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NCT ID: NCT03560739 Completed - Multiple Sclerosis Clinical Trials

A 12 Week Randomized Open Label Parallel Group Multicenter Study to Evaluate Bioequivalence of 20 mg Subcutaneous Ofatumumab Injected by Pre-filled Syringe or Autoinjector in Adult RMS Patients

Start date: September 11, 2018
Phase: Phase 2
Study type: Interventional

The primary purpose of this study is to demonstrate pharmacokinetic bioequivalence of ofatumumab injected by Pre-filled Syringe (PFS) versus Auto-Injector (AI) devices and thereby establish a bridge between the ongoing Phase 3 program and the to-be-marketed drug-device combinations

NCT ID: NCT03550924 Completed - Anesthesia Clinical Trials

Transnasal Humidified Rapid Insufflation Ventilatory Exchange in Morbidly Obese

Start date: July 26, 2018
Phase: N/A
Study type: Interventional

This project will investigate the duration of apnea without desaturation when using transnasal humidified rapid insufflation ventilatory exchange (THRIVE) vs. low flow nasal oxygen at anesthesia induction in obese patients.

NCT ID: NCT03547583 Completed - Clinical trials for Chronic Heart Failure With Preserved Ejection Fraction

Patient-reported Outcomes in Vericiguat-treated Patients With HFpEF

VITALITY-HFpEF
Start date: June 15, 2018
Phase: Phase 2
Study type: Interventional

The primary hypothesis in this trial is that the treatment with vericiguat 10 mg or 15 mg in patients with HFpEF improves the KCCQ PLS (Kansas City Cardiomyopathy Questionnaire Physical limitation score) compared to placebo after 24 weeks of treatment.

NCT ID: NCT03541811 Completed - Hemophilia Clinical Trials

Gait Examination in Patients With Hemophilia in Austria

JOSEPHA
Start date: July 2, 2018
Phase:
Study type: Observational

Hemophilia is an inherited disease caused by deficiency in varying degrees of clotting factors VIII and IX. Depending on the percentage of clotting factor in the blood the disease is categorized as "severe" (<1%, characterized by spontaneous bleedings), "moderate" (1-5%) and "mild" (>5%). If untreated, recurrent bleeding into the synovial joints often results in irreversible damage due to destruction of the cartilages and progressive joint impairment. 3d-gait analysis has been demonstrated as valid method to assess abnormal gait patterns and to monitor disease progression in patients with hemophilia (PWH). Furthermore, its outcomes facilitate the design of individually tailored therapeutic programs. In contrast to radiological examinations, 3d-gait analyses take place under weight-bearing conditions, which is a relevant issue in terms of weight-induced pain. This study aims to explore the applicability of 3-d gait analysis as biomarker (gait deviation index) for functional impairments in PWH. Besides 3-d gait scores, secondary endpoints such as biomarkers reflecting cartilage damage and a laterality-ratio of leg muscle mass (in the case of one-sided target joints) will be tested for their ability to detect functional impairments in young adults with hemophilia. Based on sample size calculation, 24 subjects aged 16-49 years, able to walk without aids or assistance will be included in each of the two groups: control (healthy, male), PWH (severe or moderate, treated prophylactically). Subjects suffering from functional impairments caused by other conditions than hemophilia, patients with bleedings within 30 days prior to the examination, PWH treated with immune-tolerance therapy and/or not successfully treated present or past high-titer factor VIII or FIX inhibitor will be excluded. Subjects will pass through a set of examinations (medical history, clinical examination, 3d-gait analysis, anthropometrics, body composition analysis, venipuncture, and urine sampling) and carry an accelerometer device for seven consecutive days. Confounder adjusted group differences will be assessed by ANCOVA with contrasts and Bonferroni correction. Correlations between the applied examination approaches will be assessed. An evidence based health promotion program including follow-up examinations, physical activity promotion, and tailored physiotherapy are being envisaged as a follow-up project (JOSEPHA phase 2).

NCT ID: NCT03541759 Completed - Postoperative Pain Clinical Trials

Pain Management After Elective Shoulder Surgery

Start date: January 2, 2018
Phase: Phase 4
Study type: Interventional

Postoperative pain management plays an important role in elective shoulder surgery. The aim of this randomized quantitative study is to compare two frequently used postoperative pain regimes (hydromorphone versus piritramide) regarding onset and duration after the effectiveness of the single-shot interscalene block has diminished.

NCT ID: NCT03538041 Completed - Clinical trials for Autoimmune Hemolytic Anemia

A Study of INCB050465 in Participants With Autoimmune Hemolytic Anemia

Start date: November 21, 2018
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of parsaclisib administered orally to participants with autoimmune hemolytic anemia (AIHA) who have decreased hemoglobin and evidence of ongoing hemolysis that requires treatment intervention.

NCT ID: NCT03532126 Completed - Clinical trials for Midface Volume Deficit

A 52-week Clinical Investigation of Princess® VOLUME PLUS Lidocaine in Subjects With Midface Volume Deficit

PRIMAvera
Start date: March 28, 2018
Phase:
Study type: Observational

This investigation aims to confirm the safety and effectiveness of Princess VOLUME PLUS Lidocaine in midface volume deficit augmentation and includes a long term safety followup.

NCT ID: NCT03529877 Completed - Clinical trials for Recessive Dystrophic Epidermolysis Bullosa

Allogeneic ABCB5-positive Stem Cells for Treatment of Epidermolysis Bullosa

Start date: February 16, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

The aim of this clinical trial is to investigate the efficacy (by monitoring overall improvement of EB symptoms) and safety (by monitoring adverse events) of three doses of allo-APZ2-EB administered intravenously to patients with recessive dystrophic epidermolysis bullosa (RDEB).

NCT ID: NCT03525990 Completed - Clinical trials for Breast Neoplasm Malignant Female

Study Evaluating the Impact of Electronic Surveys on Patient-physician Communication and Quality of Life in Breast Cancer Patients

Start date: January 10, 2018
Phase: N/A
Study type: Interventional

PRO-COM Project: Randomized-controlled study evaluating the impact of electronic patient reported outcome (ePRO) surveys on patient-physician communication and quality of life in patients with advanced breast cancer

NCT ID: NCT03525574 Completed - Cystic Fibrosis Clinical Trials

A Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy

Start date: October 9, 2018
Phase: Phase 3
Study type: Interventional

The study evaluates the long-term safety and tolerability of VX-445 in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are homozygous or heterozygous for the F508del mutation