37 results on '"Prinz-Langenohl, Reinhild"'
Search Results
2. Efficacy and safety of an early oral switch in low-risk Staphylococcus aureus bloodstream infection (SABATO): an international, open-label, parallel-group, randomised, controlled, non-inferiority trial
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Kaasch, Achim J, primary, López-Cortés, Luis Eduardo, additional, Rodríguez-Baño, Jesús, additional, Cisneros, José Miguel, additional, Dolores Navarro, M, additional, Fätkenheuer, Gerd, additional, Jung, Norma, additional, Rieg, Siegbert, additional, Lepeule, Raphaël, additional, Coutte, Laetitia, additional, Bernard, Louis, additional, Lemaignen, Adrien, additional, Kösters, Katrin, additional, MacKenzie, Colin R, additional, Soriano, Alex, additional, Hagel, Stefan, additional, Fantin, Bruno, additional, Lafaurie, Matthieu, additional, Talarmin, Jean-Philippe, additional, Dinh, Aurélien, additional, Guimard, Thomas, additional, Boutoille, David, additional, Welte, Tobias, additional, Reuter, Stefan, additional, Kluytmans, Jan, additional, Martin, Maria Luisa, additional, Forestier, Emmanuel, additional, Stocker, Hartmut, additional, Vitrat, Virginie, additional, Tattevin, Pierre, additional, Rommerskirchen, Anna, additional, Noret, Marion, additional, Adams, Anne, additional, Kern, Winfried V, additional, Hellmich, Martin, additional, Seifert, Harald, additional, Valiente, Adoración, additional, de Cueto, Marina, additional, Rodríguez, Ángel, additional, Molina, José, additional, Fischer, Julia, additional, Paul, Gregor, additional, Gallien, Sébastien, additional, Fihman, Vincent, additional, Lacasse, Marion, additional, Coustillères, Francois, additional, Becker, Christian, additional, Fuchs, André, additional, Morata, Laura, additional, Weis, Sebastian, additional, Ponscarme, Diane, additional, Khatchatourian, Lydie, additional, Rouveix, Elisabeth, additional, Merrien, Dominique, additional, Lecomte, Raphaël, additional, Veenemans, Jacobien, additional, Vilchez, Helem H., additional, Kessel, Johanna, additional, Bonten, Marc J.M., additional, Rupp, Jan, additional, Hocqueloux, Laurent, additional, Lucht, Frederic, additional, Stahl, Jean-Paul, additional, Vlek, Anne, additional, Prinz-Langenohl, Reinhild, additional, and Tolsma, Violaine, additional
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- 2024
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3. A randomised controlled multicentre investigator-blinded clinical trial comparing efficacy and safety of surgery versus complex physical decongestive therapy for lipedema (LIPLEG)
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Podda, Maurizio, Kovacs, Maximilian, Hellmich, Martin, Roth, Rebecca, Zarrouk, Marouan, Kraus, Daria, Prinz-Langenohl, Reinhild, and Cornely, Oliver A.
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- 2021
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4. Long-Term Follow-Up of Pediatric Patients with Dyskinetic Cerebral Palsy and Deep Brain Stimulation
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Koy, Anne, Kühn, Andrea A, Schiller, Petra, Huebl, Julius, Schneider, Gerd-Helge, Eckenweiler, Matthias, Rensing-Zimmermann, Cornelia, Coenen, Volker Arnd, Krauss, Joachim K, Saryyeva, Assel, Hartmann, Hans, Lorenz, Delia, Volkmann, Jens, Matthies, Cordula, Schnitzler, Alfons, Vesper, Jan, Gharabaghi, Alireza, Weiss, Daniel, Bevot, Andrea, Marks, Warren, Howser, Angela, Monbaliu, Elegast, Mueller, Joerg, Prinz-Langenohl, Reinhild, Visser-Vandewalle, Veerle, Timmermann, Lars, and STIM-CP investigators
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dyskinetic cerebral palsy ,children ,prospective ,trial ,long-term effects ,deep brain stimulation - Abstract
BACKGROUND: Deep brain stimulation (DBS) has been increasingly used in the management of dyskinetic cerebral palsy (DCP). Data on long-term effects and the safety profile are rare. OBJECTIVES: We assessed the efficacy and safety of pallidal DBS in pediatric patients with DCP. METHODS: The STIM-CP trial was a prospective, single-arm, multicenter study in which patients from the parental trial agreed to be followed-up for up to 36 months. Assessments included motor and non-motor domains. RESULTS: Of the 16 patients included initially, 14 (mean inclusion age 14 years) were assessed. There was a significant change in the (blinded) ratings of the total Dyskinesia Impairment Scale at 36 months. Twelve serious adverse events (possibly) related to treatment were documented. CONCLUSION: DBS significantly improved dyskinesia, but other outcome parameters did not change significantly. Investigations of larger homogeneous cohorts are needed to further ascertain the impact of DBS and guide treatment decisions in DCP. © 2023 The Authors. Movement Disorders published by Wiley Periodicals LLC on behalf of International Parkinson and Movement Disorder Society. ispartof: Mov Disord ispartof: location:United States status: Published online
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- 2023
5. Quality of Life after Deep Brain Stimulation of Pediatric Patients With Dyskinetic Cerebral Palsy: A Prospective, Single-Arm, Multicenter Study With a Subsequent Randomized Double-Blind Crossover (STIM-CP)
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Koy, Anne, Kuehn, Andrea A, Huebl, Julius, Schneider, Gerd-Helge, van Riesen, Anne K, Eckenweiler, Matthias, Rensing-Zimmermann, Cornelia, Coenen, Volker Arnd, Krauss, Joachim K, Saryyeva, Assel, Hartmann, Hans, Haeussler, Martin, Volkmann, Jens, Matthies, Cordula, Horn, Annette, Schnitzler, Alfons, Vesper, Jan, Gharabaghi, Alireza, Weiss, Daniel, Bevot, Andrea, Marks, Warren, Pomykal, Angela, Monbaliu, Elegast, Borck, Guntram, Mueller, Joerg, Prinz-Langenohl, Reinhild, Dembek, Till, Visser-Vandewalle, Veerle, Wirths, Jochen, Schiller, Petra, Hellmich, Martin, and Timmermann, Lars
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Canada ,dyskinetic cerebral palsy ,Adolescent ,DYSTONIA ,IMPACT ,Deep Brain Stimulation ,Clinical Neurology ,CHILDREN ,Globus Pallidus ,MANAGEMENT ,Humans ,prospective trial ,Prospective Studies ,RATING-SCALE ,Child ,OUTCOMES ,Science & Technology ,Cerebral Palsy ,deep brain stimulation ,Dystonia ,Treatment Outcome ,Neurology ,quality of life ,Dystonic Disorders ,Quality of Life ,Neurology (clinical) ,Neurosciences & Neurology ,Life Sciences & Biomedicine - Abstract
BACKGROUND: Patients with dyskinetic cerebral palsy are often severely impaired with limited treatment options. The effects of deep brain stimulation (DBS) are less pronounced than those in inherited dystonia but can be associated with favorable quality of life outcomes even in patients without changes in dystonia severity. OBJECTIVE: The aim is to assess DBS effects in pediatric patients with pharmacorefractory dyskinetic cerebral palsy with focus on quality of life. METHODS: The method used is a prospective, single-arm, multicenter study. The primary endpoint is improvement in quality of life (CPCHILD [Caregiver Priorities & Child Health Index of Life with Disabilities]) from baseline to 12 months under therapeutic stimulation. The main key secondary outcomes are changes in Burke-Fahn-Marsden Dystonia Rating Scale, Dyskinesia Impairment Scale, Gross Motor Function Measure-66, Canadian Occupational Performance Measure (COPM), and Short-Form (SF)-36. After 12 months, patients were randomly assigned to a blinded crossover to receive active or sham stimulation for 24 hours each. Severity of dystonia and chorea were blindly rated. Safety was assessed throughout. The trial was registered at ClinicalTrials.gov, number NCT02097693. RESULTS: Sixteen patients (age: 13.4 ± 2.9 years) were recruited by seven clinical sites. Primary outcome at 12-month follow-up is as follows: mean CPCHILD increased by 4.2 ± 10.4 points (95% CI [confidence interval] -1.3 to 9.7; P = 0.125); among secondary outcomes: improvement in COPM performance measure of 1.1 ± 1.5 points (95% CI 0.2 to 1.9; P = 0.02) and in the SF-36 physical health component by 5.1 ± 6.2 points (95% CI 0.7 to 9.6; P = 0.028). Otherwise, there are no significant changes. CONCLUSION: Evidence to recommend DBS as routine treatment to improve quality of life in pediatric patients with dyskinetic cerebral palsy is not yet sufficient. Extended follow-up in larger cohorts will determine the impact of DBS further to guide treatment decisions in these often severely disabled patients. © 2021 The Authors. Movement Disorders published by Wiley Periodicals LLC on behalf of International Parkinson and Movement Disorder Society. ispartof: MOVEMENT DISORDERS vol:37 issue:4 pages:799-811 ispartof: location:United States status: published
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- 2021
6. Relation of isoflavones and fiber intake in childhood to the timing of puberty
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Cheng, Guo, Remer, Thomas, Prinz-Langenohl, Reinhild, Blaszkewicz, Meinolf, Degen, Gisela H, and Buyken, Anette E
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- 2010
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7. Thalamic deep brain stimulation for Tourette Syndrome: A naturalistic trial with brief randomized, double-blinded sham-controlled periods
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Baldermann, Juan Carlos, primary, Kuhn, Jens, additional, Schüller, Thomas, additional, Kohl, Sina, additional, Andrade, Pablo, additional, Schleyken, Sophia, additional, Prinz-Langenohl, Reinhild, additional, Hellmich, Martin, additional, Barbe, Michael T., additional, Timmermann, Lars, additional, Visser-Vandewalle, Veerle, additional, and Huys, Daniel, additional
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- 2021
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8. Additional file 1 of A randomised controlled multicentre investigator-blinded clinical trial comparing efficacy and safety of surgery versus complex physical decongestive therapy for lipedema (LIPLEG)
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Podda, Maurizio, Kovacs, Maximilian, Hellmich, Martin, Roth, Rebecca, Zarrouk, Marouan, Kraus, Daria, Prinz-Langenohl, Reinhild, and Cornely, Oliver A.
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Additional file 1. SPIRIT 2013 Checklist.
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- 2021
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9. Thalamic deep brain stimulation for Tourette Syndrome: A naturalistic trial with brief randomized, double-blinded sham-controlled periods
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Baldermann, Juan Carlos, Kuhn, Jens, Schueller, Thomas, Kohl, Sina, Andrade, Pablo, Schleyken, Sophia, Prinz-Langenohl, Reinhild, Hellmich, Martin, Barbe, Michael T., Timmermann, Lars, Visser-Vandewalle, Veerle, Huys, Daniel, Baldermann, Juan Carlos, Kuhn, Jens, Schueller, Thomas, Kohl, Sina, Andrade, Pablo, Schleyken, Sophia, Prinz-Langenohl, Reinhild, Hellmich, Martin, Barbe, Michael T., Timmermann, Lars, Visser-Vandewalle, Veerle, and Huys, Daniel
- Abstract
Background: There is still a lack of controlled studies to prove efficacy of thalamic deep brain stimulation for Tourette's Syndrome. Objectives: In this controlled trial, we investigated the course of tic severity, comorbidities and quality of life during thalamic stimulation and whether changes in tic severity can be assigned to ongoing compared to sham stimulation. Methods: We included eight adult patients with medically refractory Tourette's syndrome. Bilateral electrodes were implanted in the centromedian-parafascicular-complex and the nucleus ventro-oralis internus. Tic severity, quality of life and comorbidities were assessed before surgery as well as six and twelve months after. Short randomized, double-blinded sham-controlled crossover sequences with either active or sham stimulation were implemented at both six-and twelve-months' assessments. The primary outcome measurement was the difference in the Yale Global Tic Severity Scale tic score between active and sham stimulation. Adverse events were systematically surveyed for all patients to evaluate safety. Results: Active stimulation resulted in significantly higher tic reductions than sham stimulation (F = 79.5; p = 0.001). Overall quality of life and comorbidities improved significantly in the open-label phase. Over the course of the trial two severe adverse events occurred that were resolved without sequelae. Conclusion: Our results provide evidence that thalamic stimulation is effective in improving tic severity and overall quality of life. Crucially, the reduction of tic severity was primarily driven by active stimulation. Further research may focus on improving stimulation protocols and refining patient selection to improve efficacy and safety of deep brain stimulation for Tourette's Syndrome. (c) 2021 The Authors. Published by Elsevier Inc. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
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- 2021
10. Protocol update for the SABATO trial: a randomized controlled trial to assess early oral switch therapy in low-risk Staphylococcus aureus bloodstream infection
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Kaasch, Achim J., Rommerskirchen, Anna, Hellmich, Martin, Fätkenheuer, Gerd, Prinz-Langenohl, Reinhild, Rieg, Siegbert, Kern, Winfried V., and Seifert, Harald
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Staphylococcus aureus ,Randomized controlled trial ,Oral switch therapy ,Antimicrobial ,Bacteremia ,Bloodstream infection ,Intravenous ,Update ,Pragmatic trial - Abstract
Background SABATO (Staphylococcus aureus bacteremia antibiotic treatment options) is a randomized, parallel-group, clinical non-inferiority trial designed to examine the efficacy and safety of early oral switch therapy in low-risk Staphylococcus aureus infection. The original trial protocol was published in Trials (accessible at 10.1186/s13063-015-0973-x). Here we describe final amendments to the study protocol and discuss the underlying rationale. Methods/design Three major changes were introduced into the study protocol: (1) the inclusion and exclusion criteria were refined so that patients with certain comorbidities (end-stage renal disease, severe liver disease) and uninfected foreign bodies (orthopedic prosthesis, pacemaker, implanted cardiac cardioverter-defibrillator) became eligible for enrollment under certain conditions; (2) the target sample size was decreased by choosing a conventional non-inferiority margin of 10% and converting the interim analysis (215 patients) into the final analysis; and (3) an additional follow-up visit after 30 days was introduced to allow for a closer follow-up of patients. Conclusion Changes to the study protocol were introduced to improve the enrollment and follow-up of patients. Furthermore, the decrease of the sample size will facilitate completion of the trial. Trial registration ClinicalTrials.gov, NCT01792804. Registered on 13 February 2013. German Clinical trials register, DRKS00004741. Registered on 4 October 2013, EudraCT 2013-000577-77
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- 2020
11. Calculation of red blood cell folate steady state conditions and elimination kinetics after daily supplementation with various folate forms and doses in women of childbearing age
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Pietrzik, Klaus, Lamers, Yvonne, Brämswig, Susanne, and Prinz-Langenohl, Reinhild
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- 2007
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12. Red blood cell folate concentrations increase more after supplementation with [6 S]-5-methyltetrahydrofolate than with folic acid in women of childbearing age
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Lamers, Yvonne, Prinz-Langenohl, Reinhild, Brämswig, Susanne, and Pietrzik, Klaus
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- 2006
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13. Beneficial role for folate in the prevention of colorectal and breast cancer
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Prinz-Langenohl, Reinhild, Fohr, Iris, and Pietrzik, Klaus
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- 2001
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14. Indicators of Overweight and Cardiovascular Disease Risk Factors among 11- to 17-Year-Old Boys and Girls in Germany
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Kleiser, Christina, Schienkiewitz, Anja, Rosario, Angelika Schaffrath, Prinz-Langenohl, Reinhild, Scheidt-Nave, Christa, and Mensink, Gert B.M.
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- 2011
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15. Availability of food folate in humans
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Prinz-Langenohl, Reinhild, Bronstrup, Anja, Thorand, Barbara, Hages, Monika, and Pietrzik, Klaus
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Folic acid deficiency -- Evaluation ,Folic acid in human nutrition -- Physiological aspects ,Vitamin metabolism -- Physiological aspects ,Food/cooking/nutrition - Abstract
The aim of our study was to determine whether the area-under-the-plasma-response-curve method with the positive area (AUC+) as primary analysis variable is suitable to evaluate the availability of food folate in humans. Healthy volunteers (n = 20) received four test meals in a randomized, four-period cross-over design as follows: meal A, 600 g spinach; meal B, 300 g spinach; meal C, 0.4 mg folic acid in water; meal D, folate-free control meal. Blood samples were drawn before administration of the test meals and up to 10 h postprandially. Plasma folate was significantly increased for up to 6 h after uptake of spinach and folic acid (P < 0.007), whereas the response curve after the control meal decreased slightly but significantly (P < 0.007). To calculate the net increase of plasma folate, the values were corrected by the individual predose concentrations. The AUC+ was calculated with these corrected values. The mean AUC+ was highest after consumption of meal A (71.2 [+ or -] 24.0 h x nmol/L) followed by meal C (61.8 [+ or -] 23.8 h x nmol/L) and meal B (41.4 [+ or -] 19.4 h x nmol/L). The AUC+ after meal B was significantly lower than after the other two meals (P < 0.05). The results suggest that the AUC method with multiple blood sampling is useful for assessing the availability of food folate in humans. KEY WORDS: folate; availability; spinach; AUC method; humans
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- 1999
16. Red blood cell folate concentrations increase more after supplementation with [6S]-5-methyltetrahydrofolate than with folic acid in women of childbearing age
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Lamers, Yvonne, Prinz-Langenohl, Reinhild, Bramswig, Susanne, and Pietrzik, Klaus
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Folic acid -- Influence ,Folic acid -- Comparative analysis ,Folic acid -- Case studies ,Women -- Nutritional aspects ,Food/cooking/nutrition ,Health - Abstract
Background: For the primary prevention of neural tube defects (NTDs), public health authorities recommend women of childbearing age to take 400/[micro] g folic acid/d 4 wk before conception and during the first trimester. The biologically active derivate [6S]-5-methyltetrahydrofolate ([6S]-5-MTHF) could be an alternative to folic acid. Objective: We investigated the effect of supplementation with [6S]-5-MTHF compared with that of folic acid on red blood cell folate concentration, an indicator of folate status. Design: The study was designed as a double-blind, randomized, placebo-controlled intervention trial. Healthy women (n = 144) aged 19-33 y received 400 [micro]g folic acid, the equimolar amount of [6S]-5-MTHF (416 [micro] g), 208 [micro] g [6S]-5-MTHF, or placebo as a daily supplement for 24 wk. Red blood cell and plasma folate concentrations were measured at baseline and at 4-wk intervals. Results: The increase in red blood cell folate over time was significantly higher in the group receiving 416 [micro] g [6S]-5-MTHF/d than in the groups receiving 400 [micro] g folic acid/d or 208 [micro] g [6S]-5-MTHF/d (P < 0.001). No plateau was reached in red blood cell folate concentration in the 3 treatment groups during 24 wk of intervention; however, plasma folate plateaued after 12 wk. Conclusions: We showed that administration of [6S]-5-MTHF is more effective than is folic acid supplementation at improving folate status. In addition, the study indicates that the recommended period for preconceptional folic acid supplementation should be extended to >4 wk for maximal prevention of NTDs based on folate concentrations. [6S]-5-MTHF might be an efficient and safe alternative to folic acid. Am J Clin Nutr 2006;84:156-61. KEY WORDS Red blood cell folate, 5-methyltetrahydrofolate, folic acid, preconception supplementation, neural tube defect
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- 2006
17. Supplementation with [6S]-5-methyltetrahydrofolate or folic acid equally reduces plasma total homocysteine concentrations in healthy women
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Lamers, Yvonne, Prinz-Langenohl, Reinhild, Moser, Rudolf, and Pietrzik, Klaus
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- 2004
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18. 5,10-Methylenetetrahydrofolate reductase genotype determines the plasma homocysteine-lowering effect of supplementation with 5-methyltetrahydrofolate or folic acid in healthy young women
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Fohr, Iris P, Prinz-Langenohl, Reinhild, Bronstrup, Anja, Bohlmann, Anja M, Nau, Heinz, Berthold, Heiner K, and Pietrzik, Klaus
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Homocysteine -- Physiological aspects ,Folic acid in human nutrition -- Physiological aspects ,Food/cooking/nutrition ,Health - Abstract
Background: Elevated plasma total homocysteine (tHcy) is a risk factor for vascular disease and neural tube defects. The polymorphism in the gene encoding 5,10-methylenetetrahydrofolate reductase (FAD[H.sub.2]) (MTHFR) influences the tHcy concentration and the response to tHcy-lowering therapy. Supplementation with folic acid (FA) decreases plasma tHcy, but limited data are available on the effect of 5-methyltetrahydrofolate (MTHF). Objective: We evaluated the tHcy-lowering potential of low-dose FA and of MTHF with respect to the MTHFR genotype. Design: In this randomized, placebo-controlled, double-blind study, 160 women received 400 [micro]g FA, the equimolar amount of MTHF (480 [micro]g, racemic mixture), or a placebo daily during an 8-wk treatment period. Blood samples were collected at baseline and at 4 and 8 wk. Results: Changes in plasma tHcy concentration depended on the supplemented folate derivative and the MTHFR genotype. Supplementation with FA significantly decreased tHcy concentrations by [greater than or equal to] 13% in women of all 3 genotypes after both 4 and 8 wk. The greatest decrease was 20% (P < 0.05) in the women with the TT genotype after 4 wk. MTHF supplementation also decreased tHcy, but only the women with the CT genotype had a significant decrease after 4 wk (7%; P < 0.05). The largest nonsignificant reduction (15%) occurred in the women with the TT genotype after 4 wk of MTHF supplementation. Conclusions: The response to tHcy-lowering therapy is influenced by MTHFR genotype. Women with the TT genotype seem to benefit the most from supplementation with either FA or MTHF. In women with the CT or CC genotype, FA is more effective than MTHF in lowering plasma tHcy. KEY WORDS MTHFR genotype, homocysteine, folic acid, methyltetrahydrofolate, methylenetetrahydrofolate reductase, supplementation, women
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- 2002
19. Potential determinants of obesity among children and adolescents in Germany: results from the cross-sectional KiGGS study
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Prinz-Langenohl Reinhild, Mensink Gert BM, Schaffrath Rosario Angelika, Kleiser Christina, and Kurth Bärbel-Maria
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Public aspects of medicine ,RA1-1270 - Abstract
Abstract Background Obesity among children and adolescents is a growing public health problem. The aim of the present paper is to identify potential determinants of obesity and risk groups among 3- to 17-year old children and adolescents to provide a basis for effective prevention strategies. Methods Data were collected in the German Health Interview and Examination Survey for Children and Adolescents (KiGGS), a nationally representative and comprehensive data set on health behaviour and health status of German children and adolescents. Body height and weight were measured and body mass index (BMI) was classified according to IOTF cut-off points. Statistical analyses were conducted on 13,450 non-underweight children and adolescents aged 3 to 17 years. The association between overweight, obesity and several potential determinants was analysed for this group as well as for three socio-economic status (SES) groups. A multiple logistic regression model with obesity as the dependent variable was also calculated. Results The strongest association with obesity was observed for parental overweight and for low SES. Furthermore, a positive association with both overweight (including obesity) and obesity was seen for maternal smoking during pregnancy, high weight gain during pregnancy (only for mothers of normal weight), high birth weight, and high media consumption. In addition, high intakes of meat and sausages, total beverages, water and tea, total food and beverages, as well as energy-providing food and beverages were significantly associated with overweight as well as with obesity. Long sleep time was negatively associated with obesity among 3- to 10-year olds. Determinants of obesity occurred more often among children and adolescents with low SES. Conclusion Parental overweight and a low SES are major potential determinants of obesity. Families with these characteristics should be focused on in obesity prevention.
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- 2009
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20. Early oral switch therapy in low-risk Staphylococcus aureus bloodstream infection (SABATO) : Study protocol for a randomized controlled trial
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Kaasch, Achim J, Fätkenheuer, Gerd, Prinz-Langenohl, Reinhild, Paulus, Ursula, Hellmich, Martin, Weiß, Verena, Jung, Norma, Rieg, Siegbert, Kern, Winfried V, Seifert, Harald, and SABATO trial group (with linked authorship to the individuals in the Acknowledgements section)
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Staphylococcus aureus ,Time Factors ,Research Support, Non-U.S. Gov't ,Administration, Oral ,Medicine (miscellaneous) ,Bacteremia ,Staphylococcal Infections ,Anti-Bacterial Agents ,Pragmatic Clinical Trial ,Europe ,Multicenter Study ,Treatment Outcome ,Clinical Protocols ,Recurrence ,Research Design ,Risk Factors ,Randomized Controlled Trial ,Disease Progression ,Journal Article ,Humans ,Administration, Intravenous ,Pharmacology (medical) - Abstract
Background: Current guidelines recommend that patients with Staphylococcus aureus bloodstream infection (SAB) are treated with long courses of intravenous antimicrobial therapy. This serves to avoid SAB-related complications such as relapses, local extension and distant metastatic foci. However, in certain clinical scenarios, the incidence of SAB-related complications is low. Patients with a low-risk for complications may thus benefit from an early switch to oral medication through earlier discharge and fewer complications of intravenous therapy. The major objective for the SABATO trial is to demonstrate that in patients with low-risk SAB a switch from intravenous to oral antimicrobial therapy (oral switch therapy, OST) is non-inferior to a conventional course of intravenous therapy (intravenous standard therapy, IST). Methods/Design: The trial is designed as randomized, parallel-group, observer-blinded, clinical non-inferiority trial. The primary endpoint is the occurrence of a SAB-related complication (relapsing SAB, deep-seated infection, and attributable mortality) within 90 days. Secondary endpoints are the length of hospital stay; 14-day, 30-day, and 90-day mortality; and complications of intravenous therapy. Patients with SAB who have received 5 to 7 full days of adequate intravenous antimicrobial therapy are eligible. Main exclusion criteria are polymicrobial bloodstream infection, signs and symptoms of complicated SAB (deep-seated infection, hematogenous dissemination, septic shock, and prolonged bacteremia), the presence of a non-removable foreign body, and severe comorbidity. Patients will receive either OST or IST with a protocol-approved antimicrobial and are followed up for 90 days. Four hundred thirty patients will be randomized 1:1 in two study arms. Efficacy regarding incidence of SAB-related complications is tested sequentially with a non-inferiority margin of 10 and 5 percentage points. Discussion: The SABATO trial assesses whether early oral switch therapy is safe and effective for patients with low-risk SAB. Regardless of the result, this pragmatic trial will strongly influence the standard of care in SAB. Trial registration: ClinicalTrials.gov NCT01792804registered 13 February 2013; German Clinical trials register DRKS00004741registered 4 October 2013, EudraCT 2013-000577-77. First patient randomized on 20 December 2013.
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- 2015
21. Additional file 1: of Early oral switch therapy in low-risk Staphylococcus aureus bloodstream infection (SABATO): study protocol for a randomized controlled trial
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Kaasch, Achim, FäTkenheuer, Gerd, Prinz-Langenohl, Reinhild, Paulus, Ursula, Hellmich, Martin, WeiĂ, Verena, Jung, Norma, Rieg, Siegbert, Kern, Winfried, and Seifert, Harald
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List of Ethics Committees and Competent Authorities that approved the trial. (PDF 190 kb)
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- 2015
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22. Early oral switch therapy in low-risk Staphylococcus aureus bloodstream infection (SABATO): study protocol for a randomized controlled trial
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Kaasch, Achim J., Faetkenheuer, Gerd, Prinz-Langenohl, Reinhild, Paulus, Ursula, Hellmich, Martin, Weiss, Verena, Jung, Norma, Rieg, Siegbert, Kern, Winfried V., Seifert, Harald, Kaasch, Achim J., Faetkenheuer, Gerd, Prinz-Langenohl, Reinhild, Paulus, Ursula, Hellmich, Martin, Weiss, Verena, Jung, Norma, Rieg, Siegbert, Kern, Winfried V., and Seifert, Harald
- Abstract
Background: Current guidelines recommend that patients with Staphylococcus aureus bloodstream infection (SAB) are treated with long courses of intravenous antimicrobial therapy. This serves to avoid SAB-related complications such as relapses, local extension and distant metastatic foci. However, in certain clinical scenarios, the incidence of SAB-related complications is low. Patients with a low-risk for complications may thus benefit from an early switch to oral medication through earlier discharge and fewer complications of intravenous therapy. The major objective for the SABATO trial is to demonstrate that in patients with low-risk SAB a switch from intravenous to oral antimicrobial therapy (oral switch therapy, OST) is non-inferior to a conventional course of intravenous therapy (intravenous standard therapy, IST). Methods/Design: The trial is designed as randomized, parallel-group, observer-blinded, clinical non-inferiority trial. The primary endpoint is the occurrence of a SAB-related complication (relapsing SAB, deep-seated infection, and attributable mortality) within 90 days. Secondary endpoints are the length of hospital stay; 14-day, 30-day, and 90-day mortality; and complications of intravenous therapy. Patients with SAB who have received 5 to 7 full days of adequate intravenous antimicrobial therapy are eligible. Main exclusion criteria are polymicrobial bloodstream infection, signs and symptoms of complicated SAB (deep-seated infection, hematogenous dissemination, septic shock, and prolonged bacteremia), the presence of a non-removable foreign body, and severe comorbidity. Patients will receive either OST or IST with a protocol-approved antimicrobial and are followed up for 90 days. Four hundred thirty patients will be randomized 1:1 in two study arms. Efficacy regarding incidence of SAB-related complications is tested sequentially with a non-inferiority margin of 10 and 5 percentage points. Discussion: The SABATO trial assesses whether early oral swit
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- 2015
23. Early oral switch therapy in low-risk Staphylococcus aureus bloodstream infection (SABATO): Study protocol for a randomized controlled trial
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Infection & Immunity, Epi Infectieziekten Team 1, JC onderzoeksprogramma Infectieziekten, Epi Infectieziekten, MMB, MS Interne Geneeskunde, MMB Medische Staf, Kaasch, Achim J, Fätkenheuer, Gerd, Prinz-Langenohl, Reinhild, Paulus, Ursula, Hellmich, Martin, Weiß, Verena, Jung, Norma, Rieg, Siegbert, Kern, Winfried V, Seifert, Harald, SABATO trial group (with linked authorship to the individuals in the Acknowledgements section), Infection & Immunity, Epi Infectieziekten Team 1, JC onderzoeksprogramma Infectieziekten, Epi Infectieziekten, MMB, MS Interne Geneeskunde, MMB Medische Staf, Kaasch, Achim J, Fätkenheuer, Gerd, Prinz-Langenohl, Reinhild, Paulus, Ursula, Hellmich, Martin, Weiß, Verena, Jung, Norma, Rieg, Siegbert, Kern, Winfried V, Seifert, Harald, and SABATO trial group (with linked authorship to the individuals in the Acknowledgements section)
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- 2015
24. Prevention of NTDs - Proposal of a New Concept
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Pietrzik Klaus, Prinz-Langenohl Reinhild, and Holzgreve Wolfgang
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congenital, hereditary, and neonatal diseases and abnormalities ,Pediatrics ,medicine.medical_specialty ,Pregnancy ,Spina bifida ,business.industry ,Prenatal diagnosis ,medicine.disease ,Encephalocele ,Anencephaly ,medicine ,Etiology ,Gestation ,Anencephalus ,business - Abstract
Neural tube defects (NTDs) are a heterogeneous group of serious congenital structural abnormalities of the brain and spine due to inadequate formation and/or closure of the developing brain and lower spine in the first month of pregnancy. Anencephalus, spina bifida, and encephalocele are the main manifestations of NTDs. The most serious form of NTDs is an anencephalus incompatible with life. Although NTDs can be detected by increased levels of alpha-fetoprotein and especially by ultrasound investigations early in pregnancy (Holzgreve et al., 1994), the prenatal diagnosis is often missed. After prenatal detection of NTDs, careful and comprehensive counseling of the parents is needed. Some parents select to carry the affected child to term, others decide to have a termination of pregnancy within the legal frameworks of their countries. If an anencephaly is recognized only late in gestation or even only at birth, the psychologic shock for the parents is usually prominent, and in their desperation to have at least some positive aspect in an otherwise hopeless situation parents have even requested in these rare situations to have organs transplanted from anencephalic donors (Holzgreve et al. 1987). NTDs have multiple etiologies and the role of folate, other vitamins and various micronutrients as factors in their etiology has been investigated from different angles for a long time now (Holzgreve et al., 1991, Simpson et al., 2010, 2011) A number of observational and interventional studies have demonstrated that folic acid (FA) supplementation before and in early pregnancy reduces the risk of having a NTD-affected offspring (Laurence et al., 1981; Milunsky et al. 1989; Smithells et al., 1980; Vergel et al., 1990).
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- 2012
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25. Prevention of NTDs - Proposal of a New Concept
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Prinz-Langenohl Reinhild, Pietrzik Klaus, Holzgreve Wolfgang, Prinz-Langenohl Reinhild, Pietrzik Klaus, and Holzgreve Wolfgang
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- 2012
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26. Supplementation with a multivitamin containing 800 µg of folic acid shortens the time to reach the preventive red blood cell folate concentration in healthy women
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Brämswig, Susanne, primary, Prinz-Langenohl, Reinhild, additional, Lamers, Yvonne, additional, Tobolski, Oliver, additional, Wintergerst, Eva, additional, Berthold, Heiner K., additional, and Pietrzik, Klaus, additional
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- 2009
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27. Potential determinants of obesity among children and adolescents in Germany: results from the cross-sectional KiGGS study
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Kleiser, Christina, primary, Schaffrath Rosario, Angelika, additional, Mensink, Gert BM, additional, Prinz-Langenohl, Reinhild, additional, and Kurth, Bärbel-Maria, additional
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- 2009
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28. Does long‐term supplementation with folic acid or (6S)‐5‐methyltetrahydrofolate have an impact on plasma vitamin B12 concentrations in healthy subjects?
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Lamers, Yvonne, primary, Prinz‐Langenohl, Reinhild, additional, Brδmswig, Susanne, additional, and Pietrzik, Klaus F., additional
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- 2006
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29. Calculation of red blood cell folate steady state conditions after supplementation with different folate forms and dosages
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Pietrzik, Klaus F., primary, Lamers, Yvonne, additional, Brämswig, Susanne, additional, Prinz‐Langenohl, Reinhild, additional, and Pietrzik, Claus U., additional
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- 2006
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30. Folate Status in Germany 1997–2000
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Gonzalez-Gross, Marcela, primary, Prinz-Langenohl, Reinhild, additional, and Pietrzik, Klaus, additional
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- 2002
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31. Effects of folic acid and combinations of folic acid and vitamin B-12 on plasma homocysteine concentrations in healthy, young women[1,2]
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Bronstrup, Anja, Hages, Monika, Prinz-Langenohl, Reinhild, and Pietrzik, Klaus
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Homocysteine -- Measurement ,Folic acid -- Physiological aspects ,Young women -- Physiological aspects ,Food/cooking/nutrition ,Health - Abstract
Background: Elevated plasma homocysteine concentrations are considered to be a risk factor tot vascular disease and fetal malformations such as neural tube detects. Recent studies have shown that plasma homocysteine can be lowered by folic acid in amounts corresponding to 1-2 times the recommended dietary allowance. Preliminary evidence indicates that vitamin B-12 may be beneficial when included in supplements or in a food-fortification regimen together with folic acid. Objective: We aimed to compare the homocysteine-lowering potential of a folic acid supplement with that of 2 supplements containing different doses of vitamin B-12 in addition to folic acid. Design: Female volunteers of childbearing age (n = 150) received a placebo for 4 wk followed by a 4-wk treatment with either 400 [micro]g folic acid, 400 [micro]g folic acid + 6 [micro]g vitamin B-12, or 400 [micro]g folic acid + 400 [micro]g vitamin B-12. Results: Significant reductions (P [is less than] 0.001) in plasma homocysteine were observed in all groups receiving vitamin treatment. The effect observed with the combination of folic acid + 400 peg vitamin B-12 (total homocysteine, -18%) was significantly larger than that with a supplement containing folic acid alone (total homocysteine, -11%) (P [is less than] 0.05). Folic acid in combination with a low vitamin B-12 dose (6 [micro]g) affected homocysteine as well (-15%). Conclusions: These results suggest that the addition of vitamin B-12 to folic acid supplements or enriched foods maximizes the reduction of homocysteine and may thus increase the benefits of the proposed measures in the prevention of vascular disease and neural tube defects. Am J Clin Nutr 1998;68:1104-10. KEY WORDS Folic acid, vitamin B-12, supplementation, homocysteine, neural tube defect, cardiovascular disease, women
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- 1998
32. Quality of Life after Deep Brain Stimulation of Pediatric Patients With Dyskinetic Cerebral Palsy: A Prospective, Single-Arm, Multicenter Study With a Subsequent Randomized Double-Blind Crossover (STIM-CP)
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Koy, Anne, Kuehn, Andrea A., Huebl, Julius, Schneider, Gerd-Helge, van Riesen, Anne K., Eckenweiler, Matthias, Rensing-Zimmermann, Cornelia, Coenen, Volker Arnd, Krauss, Joachim K., Saryyeva, Assel, Hartmann, Hans, Haeussler, Martin, Volkmann, Jens, Matthies, Cordula, Horn, Annette, Schnitzler, Alfons, Vesper, Jan, Gharabaghi, Alireza, Weiss, Daniel, Bevot, Andrea, Marks, Warren, Pomykal, Angela, Monbaliu, Elegast, Borck, Guntram, Mueller, Joerg, Prinz-Langenohl, Reinhild, Dembek, Till, Visser-Vandewalle, Veerle, Wirths, Jochen, Schiller, Petra, Hellmich, Martin, Timmermann, Lars, Koy, Anne, Kuehn, Andrea A., Huebl, Julius, Schneider, Gerd-Helge, van Riesen, Anne K., Eckenweiler, Matthias, Rensing-Zimmermann, Cornelia, Coenen, Volker Arnd, Krauss, Joachim K., Saryyeva, Assel, Hartmann, Hans, Haeussler, Martin, Volkmann, Jens, Matthies, Cordula, Horn, Annette, Schnitzler, Alfons, Vesper, Jan, Gharabaghi, Alireza, Weiss, Daniel, Bevot, Andrea, Marks, Warren, Pomykal, Angela, Monbaliu, Elegast, Borck, Guntram, Mueller, Joerg, Prinz-Langenohl, Reinhild, Dembek, Till, Visser-Vandewalle, Veerle, Wirths, Jochen, Schiller, Petra, Hellmich, Martin, and Timmermann, Lars
- Abstract
Background Patients with dyskinetic cerebral palsy are often severely impaired with limited treatment options. The effects of deep brain stimulation (DBS) are less pronounced than those in inherited dystonia but can be associated with favorable quality of life outcomes even in patients without changes in dystonia severity. Objective The aim is to assess DBS effects in pediatric patients with pharmacorefractory dyskinetic cerebral palsy with focus on quality of life. Methods The method used is a prospective, single-arm, multicenter study. The primary endpoint is improvement in quality of life (CPCHILD [Caregiver Priorities & Child Health Index of Life with Disabilities]) from baseline to 12 months under therapeutic stimulation. The main key secondary outcomes are changes in Burke-Fahn-Marsden Dystonia Rating Scale, Dyskinesia Impairment Scale, Gross Motor Function Measure-66, Canadian Occupational Performance Measure (COPM), and Short-Form (SF)-36. After 12 months, patients were randomly assigned to a blinded crossover to receive active or sham stimulation for 24 hours each. Severity of dystonia and chorea were blindly rated. Safety was assessed throughout. The trial was registered at ClinicalTrials.gov, number NCT02097693. Results Sixteen patients (age: 13.4 +/- 2.9 years) were recruited by seven clinical sites. Primary outcome at 12-month follow-up is as follows: mean CPCHILD increased by 4.2 +/- 10.4 points (95% CI [confidence interval] -1.3 to 9.7; P = 0.125); among secondary outcomes: improvement in COPM performance measure of 1.1 +/- 1.5 points (95% CI 0.2 to 1.9; P = 0.02) and in the SF-36 physical health component by 5.1 +/- 6.2 points (95% CI 0.7 to 9.6; P = 0.028). Otherwise, there are no significant changes. Conclusion Evidence to recommend DBS as routine treatment to improve quality of life in pediatric patients with dyskinetic cerebral palsy is not yet sufficient. Extended follow-up in larger cohorts will determine the impact of DBS further to guide trea
33. Quality of Life after Deep Brain Stimulation of Pediatric Patients With Dyskinetic Cerebral Palsy: A Prospective, Single-Arm, Multicenter Study With a Subsequent Randomized Double-Blind Crossover (STIM-CP)
- Author
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Koy, Anne, Kuehn, Andrea A., Huebl, Julius, Schneider, Gerd-Helge, van Riesen, Anne K., Eckenweiler, Matthias, Rensing-Zimmermann, Cornelia, Coenen, Volker Arnd, Krauss, Joachim K., Saryyeva, Assel, Hartmann, Hans, Haeussler, Martin, Volkmann, Jens, Matthies, Cordula, Horn, Annette, Schnitzler, Alfons, Vesper, Jan, Gharabaghi, Alireza, Weiss, Daniel, Bevot, Andrea, Marks, Warren, Pomykal, Angela, Monbaliu, Elegast, Borck, Guntram, Mueller, Joerg, Prinz-Langenohl, Reinhild, Dembek, Till, Visser-Vandewalle, Veerle, Wirths, Jochen, Schiller, Petra, Hellmich, Martin, Timmermann, Lars, Koy, Anne, Kuehn, Andrea A., Huebl, Julius, Schneider, Gerd-Helge, van Riesen, Anne K., Eckenweiler, Matthias, Rensing-Zimmermann, Cornelia, Coenen, Volker Arnd, Krauss, Joachim K., Saryyeva, Assel, Hartmann, Hans, Haeussler, Martin, Volkmann, Jens, Matthies, Cordula, Horn, Annette, Schnitzler, Alfons, Vesper, Jan, Gharabaghi, Alireza, Weiss, Daniel, Bevot, Andrea, Marks, Warren, Pomykal, Angela, Monbaliu, Elegast, Borck, Guntram, Mueller, Joerg, Prinz-Langenohl, Reinhild, Dembek, Till, Visser-Vandewalle, Veerle, Wirths, Jochen, Schiller, Petra, Hellmich, Martin, and Timmermann, Lars
- Abstract
Background Patients with dyskinetic cerebral palsy are often severely impaired with limited treatment options. The effects of deep brain stimulation (DBS) are less pronounced than those in inherited dystonia but can be associated with favorable quality of life outcomes even in patients without changes in dystonia severity. Objective The aim is to assess DBS effects in pediatric patients with pharmacorefractory dyskinetic cerebral palsy with focus on quality of life. Methods The method used is a prospective, single-arm, multicenter study. The primary endpoint is improvement in quality of life (CPCHILD [Caregiver Priorities & Child Health Index of Life with Disabilities]) from baseline to 12 months under therapeutic stimulation. The main key secondary outcomes are changes in Burke-Fahn-Marsden Dystonia Rating Scale, Dyskinesia Impairment Scale, Gross Motor Function Measure-66, Canadian Occupational Performance Measure (COPM), and Short-Form (SF)-36. After 12 months, patients were randomly assigned to a blinded crossover to receive active or sham stimulation for 24 hours each. Severity of dystonia and chorea were blindly rated. Safety was assessed throughout. The trial was registered at ClinicalTrials.gov, number NCT02097693. Results Sixteen patients (age: 13.4 +/- 2.9 years) were recruited by seven clinical sites. Primary outcome at 12-month follow-up is as follows: mean CPCHILD increased by 4.2 +/- 10.4 points (95% CI [confidence interval] -1.3 to 9.7; P = 0.125); among secondary outcomes: improvement in COPM performance measure of 1.1 +/- 1.5 points (95% CI 0.2 to 1.9; P = 0.02) and in the SF-36 physical health component by 5.1 +/- 6.2 points (95% CI 0.7 to 9.6; P = 0.028). Otherwise, there are no significant changes. Conclusion Evidence to recommend DBS as routine treatment to improve quality of life in pediatric patients with dyskinetic cerebral palsy is not yet sufficient. Extended follow-up in larger cohorts will determine the impact of DBS further to guide trea
34. Long-Term Follow-Up of Pediatric Patients with Dyskinetic Cerebral Palsy and Deep Brain Stimulation.
- Author
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Koy A, Kühn AA, Schiller P, Huebl J, Schneider GH, Eckenweiler M, Rensing-Zimmermann C, Coenen VA, Krauss JK, Saryyeva A, Hartmann H, Lorenz D, Volkmann J, Matthies C, Schnitzler A, Vesper J, Gharabaghi A, Weiss D, Bevot A, Marks W, Howser A, Monbaliu E, Mueller J, Prinz-Langenohl R, Visser-Vandewalle V, and Timmermann L
- Subjects
- Humans, Child, Adolescent, Follow-Up Studies, Prospective Studies, Globus Pallidus, Treatment Outcome, Cerebral Palsy therapy, Deep Brain Stimulation, Dyskinesias etiology, Dyskinesias therapy, Movement Disorders therapy
- Abstract
Background: Deep brain stimulation (DBS) has been increasingly used in the management of dyskinetic cerebral palsy (DCP). Data on long-term effects and the safety profile are rare., Objectives: We assessed the efficacy and safety of pallidal DBS in pediatric patients with DCP., Methods: The STIM-CP trial was a prospective, single-arm, multicenter study in which patients from the parental trial agreed to be followed-up for up to 36 months. Assessments included motor and non-motor domains., Results: Of the 16 patients included initially, 14 (mean inclusion age 14 years) were assessed. There was a significant change in the (blinded) ratings of the total Dyskinesia Impairment Scale at 36 months. Twelve serious adverse events (possibly) related to treatment were documented., Conclusion: DBS significantly improved dyskinesia, but other outcome parameters did not change significantly. Investigations of larger homogeneous cohorts are needed to further ascertain the impact of DBS and guide treatment decisions in DCP. © 2023 The Authors. Movement Disorders published by Wiley Periodicals LLC on behalf of International Parkinson and Movement Disorder Society., (© 2023 The Authors. Movement Disorders published by Wiley Periodicals LLC on behalf of International Parkinson and Movement Disorder Society.)
- Published
- 2023
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35. Quality of Life After Deep Brain Stimulation of Pediatric Patients with Dyskinetic Cerebral Palsy: A Prospective, Single-Arm, Multicenter Study with a Subsequent Randomized Double-Blind Crossover (STIM-CP).
- Author
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Koy A, Kühn AA, Huebl J, Schneider GH, van Riesen AK, Eckenweiler M, Rensing-Zimmermann C, Coenen VA, Krauss JK, Saryyeva A, Hartmann H, Haeussler M, Volkmann J, Matthies C, Horn A, Schnitzler A, Vesper J, Gharabaghi A, Weiss D, Bevot A, Marks W, Pomykal A, Monbaliu E, Borck G, Mueller J, Prinz-Langenohl R, Dembek T, Visser-Vandewalle V, Wirths J, Schiller P, Hellmich M, and Timmermann L
- Subjects
- Adolescent, Canada, Child, Globus Pallidus, Humans, Prospective Studies, Quality of Life, Treatment Outcome, Cerebral Palsy therapy, Deep Brain Stimulation methods, Dystonia, Dystonic Disorders
- Abstract
Background: Patients with dyskinetic cerebral palsy are often severely impaired with limited treatment options. The effects of deep brain stimulation (DBS) are less pronounced than those in inherited dystonia but can be associated with favorable quality of life outcomes even in patients without changes in dystonia severity., Objective: The aim is to assess DBS effects in pediatric patients with pharmacorefractory dyskinetic cerebral palsy with focus on quality of life., Methods: The method used is a prospective, single-arm, multicenter study. The primary endpoint is improvement in quality of life (CPCHILD [Caregiver Priorities & Child Health Index of Life with Disabilities]) from baseline to 12 months under therapeutic stimulation. The main key secondary outcomes are changes in Burke-Fahn-Marsden Dystonia Rating Scale, Dyskinesia Impairment Scale, Gross Motor Function Measure-66, Canadian Occupational Performance Measure (COPM), and Short-Form (SF)-36. After 12 months, patients were randomly assigned to a blinded crossover to receive active or sham stimulation for 24 hours each. Severity of dystonia and chorea were blindly rated. Safety was assessed throughout. The trial was registered at ClinicalTrials.gov, number NCT02097693., Results: Sixteen patients (age: 13.4 ± 2.9 years) were recruited by seven clinical sites. Primary outcome at 12-month follow-up is as follows: mean CPCHILD increased by 4.2 ± 10.4 points (95% CI [confidence interval] -1.3 to 9.7; P = 0.125); among secondary outcomes: improvement in COPM performance measure of 1.1 ± 1.5 points (95% CI 0.2 to 1.9; P = 0.02) and in the SF-36 physical health component by 5.1 ± 6.2 points (95% CI 0.7 to 9.6; P = 0.028). Otherwise, there are no significant changes., Conclusion: Evidence to recommend DBS as routine treatment to improve quality of life in pediatric patients with dyskinetic cerebral palsy is not yet sufficient. Extended follow-up in larger cohorts will determine the impact of DBS further to guide treatment decisions in these often severely disabled patients. © 2021 The Authors. Movement Disorders published by Wiley Periodicals LLC on behalf of International Parkinson and Movement Disorder Society., (© 2021 The Authors. Movement Disorders published by Wiley Periodicals LLC on behalf of International Parkinson and Movement Disorder Society.)
- Published
- 2022
- Full Text
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36. Early oral switch therapy in low-risk Staphylococcus aureus bloodstream infection (SABATO): study protocol for a randomized controlled trial.
- Author
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Kaasch AJ, Fätkenheuer G, Prinz-Langenohl R, Paulus U, Hellmich M, Weiß V, Jung N, Rieg S, Kern WV, and Seifert H
- Subjects
- Administration, Intravenous, Administration, Oral, Anti-Bacterial Agents adverse effects, Bacteremia diagnosis, Bacteremia microbiology, Bacteremia mortality, Clinical Protocols, Disease Progression, Europe, Humans, Recurrence, Research Design, Risk Factors, Staphylococcal Infections diagnosis, Staphylococcal Infections microbiology, Staphylococcal Infections mortality, Staphylococcus aureus isolation & purification, Time Factors, Treatment Outcome, Anti-Bacterial Agents administration & dosage, Bacteremia drug therapy, Staphylococcal Infections drug therapy, Staphylococcus aureus drug effects
- Abstract
Background: Current guidelines recommend that patients with Staphylococcus aureus bloodstream infection (SAB) are treated with long courses of intravenous antimicrobial therapy. This serves to avoid SAB-related complications such as relapses, local extension and distant metastatic foci. However, in certain clinical scenarios, the incidence of SAB-related complications is low. Patients with a low-risk for complications may thus benefit from an early switch to oral medication through earlier discharge and fewer complications of intravenous therapy. The major objective for the SABATO trial is to demonstrate that in patients with low-risk SAB a switch from intravenous to oral antimicrobial therapy (oral switch therapy, OST) is non-inferior to a conventional course of intravenous therapy (intravenous standard therapy, IST)., Methods/design: The trial is designed as randomized, parallel-group, observer-blinded, clinical non-inferiority trial. The primary endpoint is the occurrence of a SAB-related complication (relapsing SAB, deep-seated infection, and attributable mortality) within 90 days. Secondary endpoints are the length of hospital stay; 14-day, 30-day, and 90-day mortality; and complications of intravenous therapy. Patients with SAB who have received 5 to 7 full days of adequate intravenous antimicrobial therapy are eligible. Main exclusion criteria are polymicrobial bloodstream infection, signs and symptoms of complicated SAB (deep-seated infection, hematogenous dissemination, septic shock, and prolonged bacteremia), the presence of a non-removable foreign body, and severe comorbidity. Patients will receive either OST or IST with a protocol-approved antimicrobial and are followed up for 90 days. Four hundred thirty patients will be randomized 1:1 in two study arms. Efficacy regarding incidence of SAB-related complications is tested sequentially with a non-inferiority margin of 10 and 5 percentage points., Discussion: The SABATO trial assesses whether early oral switch therapy is safe and effective for patients with low-risk SAB. Regardless of the result, this pragmatic trial will strongly influence the standard of care in SAB., Trial Registration: ClinicalTrials.gov NCT01792804 registered 13 February 2013; German Clinical trials register DRKS00004741 registered 4 October 2013, EudraCT 2013-000577-77 . First patient randomized on 20 December 2013.
- Published
- 2015
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37. Supplementation with a multivitamin containing 800 microg of folic acid shortens the time to reach the preventive red blood cell folate concentration in healthy women.
- Author
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Brämswig S, Prinz-Langenohl R, Lamers Y, Tobolski O, Wintergerst E, Berthold HK, and Pietrzik K
- Subjects
- Adolescent, Adult, Diet, Diet Records, Double-Blind Method, Female, Folic Acid analysis, Folic Acid blood, Homocysteine blood, Humans, Methionine, Reference Values, Riboflavin blood, Time Factors, Vitamin B 12 blood, Vitamin B 6 blood, Young Adult, Dietary Supplements, Erythrocytes chemistry, Folic Acid administration & dosage, Micronutrients administration & dosage, Neural Tube Defects prevention & control, Nutritional Status
- Abstract
Background: The lowest risk of having a child with a neural tube defect (NTD) was related to red blood cell (RBC) folate concentrations of >906 nmol/L. For NTD prevention, it is recommended that women use periconceptional supplementation of 400 microg/day folic acid. Using this dose previous studies indicate that RBC folate >906 nmol/L was not reached within four weeks of supplementation., Objective: The effectiveness of a multivitamin/multimineral supplement containing 800 microg folic acid (verum) was evaluated using RBC folate concentration exceeding 906 nmol/L as primary endpoint. In addition, the time frame of achieving the threshold level was established as well as the effect of supplementation of other B vitamins on folate metabolism., Subjects and Methods: 46 healthy females received 800 microg/day of folic acid or placebo for 16 weeks. Blood samples were collected in four-week intervals. Plasma and RBC folate were measured with the microbiological method., Results: Mean (+/-SED) RBC folate increased over time to 1430+/-53 nmol/L, but did not reach a steady state after 16 weeks of intervention. Mean time to reach the target level was 4.2 +/- 3.5 weeks in the verum group. Intake of verum also led to an increase over time of plasma folate., Conclusions: Preventive RBC folate concentration of more than 906 nmol/L can be reached within four weeks of supplementation with daily intake of 800 microg folic acid. With respect to NTD prevention, we suggest the re-evaluation of the current recommendation of folic acid supplementation.
- Published
- 2009
- Full Text
- View/download PDF
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