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NCT ID: NCT04447261 Completed - Obesity Clinical Trials

A Study to Test How Well Different Doses of BI 1356225 Are Tolerated by Men and Women With Obesity or Overweight

Start date: June 30, 2020
Phase: Phase 1
Study type: Interventional

The primary objective of this trial is to investigate safety and tolerability of BI 1356225 in male and female patients with overweight and obesity following oral administration of multiple rising doses per day over 28 days. Secondary objectives are the exploration of pharmacokinetics (PK) of BI 1356225 after multiple oral dosing. Additionally, the relative bioavailability (BA) of midazolam and celecoxib in the presence and absence of BI 1356225 will be evaluated

NCT ID: NCT04444895 Completed - Angioedema Clinical Trials

A Study of Long-Term Safety and Efficacy of Lanadelumab for Prevention of Acute Attacks of Non-histaminergic Angioedema With Normal C1-Inhibitor

Start date: February 5, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the long-term safety and efficacy of repeated subcutaneous (SC) administration of lanadelumab in adolescents and adults with non-histaminergic angioedema with normal C1-inhibitor who completed study SHP643-303 (NCT04206605).

NCT ID: NCT04444804 Completed - Clinical trials for Venous Thromboembolism

Study to Compare the Effectiveness of Rivaroxaban (Xarelto) Versus Low-molecular-weight Heparin (LMWH) and Phenprocoumon for the Treatment and Secondary Prevention of Venous Thromboembolism in Routine Clinical Practice in Germany

Start date: July 31, 2020
Phase:
Study type: Observational

Researcher in this study want to compare the effectiveness of Rivaroxaban (Xarelto) versus low-molecular-weight heparin (LMWH) and phenprocoumon for the treatment and secondary prevention of venous thromboembolism by evaluating routine clinical practice data from research database in Germany. VTE is defined by a blood clot in the leg or lower extremity (deep vein thrombosis) or a blood clot in the lung (pulmonary embolism). Treatment of VTE traditionally consists of acute anticoagulation treatment with heparin (mainly LMWH), followed by maintenance oral anticoagulation with vitamin-K antagonists (in Germany mainly phenprocoumon). Rivaroxaban, a direct-acting oral anticoagulants (DOAC), is an alternative VTE treatment and has been approved for both the acute and maintenance phase of VTE treatment. The study will enroll adult male or female patients who are newly diagnosed with VTE and are already on the treatment with Rivaroxaban or LMWH and phenprocoumon. Researchers are especially interested whether patients experience under treatment any VTE events or fatal bleedings.

NCT ID: NCT04444661 Completed - Osteoporosis Clinical Trials

Effects of COVID-19 Induced Deconditioning After Long-term High Intensity Resistance Exercise

Start date: June 10, 2020
Phase:
Study type: Observational

Osteosarcopenia designates the simultaneous presence of sarcopenia and osteopenia; both chronic conditions of advanced age. Dynamic-resistance exercise (DRT) might be the most powerful agent to fight osteosarcopenia. Indeed, in the present FrOST study, we clearly determine the positive effect of slightly adapted 18 month high-intensity (HIT)-DRT on bone mineral density (BMD), sarcopenia and other health related parameters in osteosarcopenic men. However, after a short training break, COVID-19 induced lock down prevented a re-start of the HIT resistance exercise training in the FrOST cohort. The aim of the present observational study is thus to determine the effects of 6 months of deconditioning on health related parameters under special regard of osteosarcopenia in this cohort of older men with osteosarcopenia.

NCT ID: NCT04442269 Completed - Clinical trials for Allergic Bronchopulmonary Aspergillosis

Investigating Treatment With Dupilumab in Patients With Allergic Bronchopulmonary Aspergillosis (ABPA) (LIBERTY ABPA AIRED)

Start date: September 15, 2020
Phase: Phase 2
Study type: Interventional

The primary objective of the study is to evaluate the efficacy of dupilumab on lung function in participants with Allergic Bronchopulmonary Aspergillosis (ABPA). The secondary objectives of the study are: - To evaluate the effects of dupilumab on exacerbations in participants with ABPA - To evaluate the effects of dupilumab on ABPA-related exacerbations - To evaluate the effects of dupilumab on hospitalization/emergency department (ED)/urgent care visits in participants with ABPA - To evaluate the effects of dupilumab on asthma control in participants with ABPA - To evaluate the effects of dupilumab on health-related quality of life (HRQoL) in participants with ABPA - To evaluate the effects of dupilumab on serum total immunoglobulin E (IgE) and Aspergillus-specific IgE concentrations - To evaluate the effects of dupilumab on Fractional exhaled Nitric Oxide (FeNO) levels - To evaluate safety and tolerability of dupilumab in participants with ABPA - To evaluate dupilumab concentrations in serum and the incidence of anti-dupilumab antibodies in participants with ABPA

NCT ID: NCT04440592 Completed - Clinical trials for Diffuse Cutaneous Systemic Sclerosis

Study to Evaluate Efficacy, Safety, and Tolerability of MT-7117 in Subjects With Diffuse Cutaneous Systemic Sclerosis

Start date: February 5, 2021
Phase: Phase 2
Study type: Interventional

To evaluate the efficacy of MT-7117 treatment in subjects with diffuse cutaneous systemic sclerosis (dcSSc) using the American College of Rheumatology Composite Response Index in Diffuse Systemic Sclerosis (ACR CRISS) at Week 52

NCT ID: NCT04439929 Completed - Clinical trials for Healthy Participants

Comparative Pharmacokinetic, Safety, Tolerability and Immunogenicity Study of Adalimumab in Healthy Subjects

Start date: July 17, 2019
Phase: Phase 1
Study type: Interventional

This is a randomized, double-blind, two-arm, parallel group, single-dose study to demonstrate pharmacokinetic, safety, tolerability and immunogenicity similarity of biosimilar candidate TUR01 to EU-sourced Humira® in healthy participants after administration of adalimumab.

NCT ID: NCT04439734 Completed - Clinical trials for Athletic Performance

Effects of Whole-body Electromyostimulation on Golf Performance in Amateur Golfers

Start date: July 1, 2020
Phase: N/A
Study type: Interventional

Golf is becoming increasingly popular in Germany. However, the biomechanical and motor challenge of golf should not be underestimated. Nevertheless, only very few amateur golfers carry out serious preparation and conditioning as part of a strength/stabilization program. The main argument for this limitation is the aspect of "limited time resources". A solution to this problem could therefore be the time-effective and highly individualizable whole-body electromyostimulation (WB-EMS) technology. The aim of the present study is to evaluate the effectiveness of 16 weeks of WB-EMS application on trunk stability and clubhead speed in male amateur golfers in a (randomized) controlled setting.

NCT ID: NCT04439539 Completed - Clinical trials for Hepatitis B, Chronic

A Study of JNJ-73763989, Pegylated Interferon Alpha-2a, Nucleos(t)Ide Analog (NA) With or Without JNJ-56136379 in Treatment-naive Participants With Hepatitis B e Antigen (HBeAg) Positive Chronic Hepatitis B Virus (HBV) Infection

Start date: September 14, 2020
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy of a treatment regimen of JNJ-73763989 + pegylated interferon alpha-2a (PegIFN-alpha-2a) + nucleos(t)ide analog (NA).

NCT ID: NCT04438499 Completed - Urodynamics Clinical Trials

e۰Sense® Catheter Clinical Investigation

Start date: June 16, 2020
Phase: N/A
Study type: Interventional

This pre-market study will be conducted on consenting patients undergoing a medically prescribed, invasive, conventional urodynamics (UDS) test using the investigational device (e۰Sense® urodynamic catheters). Data pertaining to the safety, effectiveness and usability of the catheters will be collected.