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The Shoulder Diary

Primary Objective  To describe how patients experience the first eight weeks after shoulder arthroplasty, regarding pain and pain medication, shoulder function and quality of life.  To determine the direct effect of patients' expectations on…

The effect of pelvic floor muscle training on bowel symptoms after low anterior resection for rectal cancer.

The proportion of successful patients, defined as an improvement in LARS category, will be 25% larger in the experimental group than in the control group (in which 10 % improvement is assumed).

Treatment Effect of Bone Anchored Protraction in Cleft Patients

Bone-anchored maxillary protraction therapy improves facial profile in cleft children.

The effect of one session of high velocity low amplitude thrust manipulation (HVLA) at the cervicothoracic junction (CTJ) and thoracolumbar junction (TLJ) in healthy female elite waterpolo players on maximal throwing speed performance, functional movement (SPADI and DASH questionnaire ), pain (NPRS questionnaire), range of motion (inclinometer (CTJ, TLJ and shoulder) and strength of the muscles in the shoulder region by hand-held dynamometer.

In this study we are interested in the effect of high velocity low amplitude thrust manipulation at the cervical-thoracic junction and thoracic-lumbar junction in healthy elite female water polo players on :maximum throwing speedfunctional movement…

Utilizing Novel dipole density Capabilities to Objectively Visualize the Etiology of Rhythms in Atrial Fibrillation (UNCOVER-AF)

The objective of the clinical study is to evaluate the incidence of device- and procedure-related safety, efficacy, and efficiency (6-and 12-month outcomes) when using the AcQMap as an imaging and mapping system for ablation of persistent atrial…

The effect of twice daily aclidinium bromide/formoterol fumarate 340/12 mcg vs. once daily tiotropium 'respimat' 5mcg on static and dynamic hyperinflation in patients with COPD during 24 hours.

Therefore we aimed to study the 24 hour effect of twice daily aclidinium/formeterol versus once daily tiotropium on serial static and dynamic lung hyperinflation measurements, as well as (24 hour) symptoms and sleep quality. Tiotropium was chosen as…

A two-part randomized, double-blind, placebo-controlled multicenter dose ranging and confirmatory study to assess the safety and efficacy of VAY736 in autoimmune hepatitis patients with incomplete response to or intolerance of standard therapy (AMBER)

Part 1 - To determine effects of different ianalumab doses on ALT normalization at Week 24 in patients with AIH who are incomplete responders or intolerant to standard therapy.Part 2 - To confirm the efficacy (biochemical and histological remission…

Phase 1b multi-indication study of anetumab ravtansine (BAY 94-9343) in patients with
mesothelin expressing advanced or recurrent malignancies

The key purpose of Safety lead in part of this study is to determine the maximum tolerable dose of anebumab ravtansine in combination with cisplatin for treatment of mesothelin-expressing cholangiocarcinoma, and similar for the combination with…

AssessinG Efficacy of carboplatin and ATezOlizumab in metastatic Lobular breast cancer: GELATO-trial

To assess the efficacy of atezolizumab in combination with carboplatin in metastatic ILC

An Open-Label, Randomized, Crossover Pilot Study to Evaluate the Pharmacokinetics and Relative Bioavailability of JZP-324 Formulations vs. Xyrem in Healthy Subjects

Part 1:The purpose of the study is to compare 5 different JZP-324 formulations to Xyrem. It will be investigated how quickly and to what extent JZP-324 is absorbed and eliminated from the body (this is called pharmacokinetics) when compared to Xyrem…

Clinical trial to evaluate safety and dose response using the C2 CryoBalloonTM 180 Ablation system for the treatment of dysplastic Barrett*s esophagus

The objective of this study is to determine the safe and efficacious dose required to eradicate LGD or HGD in BE, or residual BE after endoscopic removal of early cancer (*therapeutic dose*), using the C2 CryoBalloon 180 Ablation System. *Dose* is…

Helping pregnant women stop smoking with a dual tasking treatment

Specifically, the first objective of the current study is to compare the efficacy of a dual tasking treatment versus treatment as usual in the treatment of smoking addiction in a pregnant population on smoking outcomes. Secondary objectives:Effect…

BOOSTH: serious gaming in combination with physical activity promotion.

The primary aim of this study is to examine prospectively the effects of BOOSTH on moderate to vigorous PA (MVPA) in 8-12 year old overweight/ obese children participating in the COACH program.

A modular, multi-arm, multi-part, first time in patient study to evaluate the
safety and tolerability of OMO-1, alone and in combination with anti-cancer
treatments, in patients with locally advanced, unresectable or metastatic
solid malignancies

Core:Core Primary Objective:* To investigate the safety and tolerability of OMO-1 when given orally to patients with locally advanced, unresectable or metastatic solid malignancies, alone or in combination with anti-cancer treatments, and define the…

An International, Multicenter, Open-label, Long Term Extension Study Evaluating the Safety of Diacerein 1% Ointment Topical Formulation in Subjects with Epidermolysis Bullosa Simplex (EBS)

The primary objective of this study is to evaluate the long-term safety and tolerability of Diacerein 1% Ointment for 2 treatment cycles in subjects with EBS that were previously enrolled in studies CCP-020-301 or CCP-020-101.

A Multi-Center, Open-Label Phase 1b/2 Study of a Novel FGFR3 Inhibitor (B-701) Combined with Pembrolizumab in Subjects with Locally Advanced or Metastatic Urothelial Carcinoma who have Progressed Following Platinum-based Chemotherapy or are not eligible for cisplatin-containing chemotherapy.

Phase 1b Primary Objective: 1. To establish the initial safety and determine a recommended Phase 2 dose (RP2D) of vofatamab in combination with pembrolizumabPhase 2 Primary Objectives: 1. To evaluate the safety and tolerability of vofatamab plus…

A Randomized, Controlled Double-blind Study Comparing the Efficacy and Safety of Orelvo (voclosporin) (23.7 mg Twice Daily) with Placebo in Achieving Renal Response in Subjects with Active Lupus Nephritis

Main objective:To assess the efficacy of Orelvo (voclosporin) compared with placebo in achieving renal response after 52 weeks of therapy in subjects with active lupus nephritis (LN)Secondary objective:To assess the safety and tolerability of Orelvo…

An Open Label Phase 1, First-In-Human Study of TRAIL Receptor Agonist ABBV-621 in Subjects with Previously-Treated Solid Tumors and Hematologic Malignancies

The primary objectives are to determine the maximum tolerated dose (MTD) and/or recommended phase two dose (RP2D) of ABBV-621 and to evaluate pharmacokinetics (PK) of (A) single agent ABBV-621; and (B) the combination of ABBV-621 and venetoclax in…

European Proof-of-Concept Therapeutic Stratification Trial of Molecular Anomalies in Relapsed or Refractory Tumors (ESMART)

This study has been transitioned to CTIS with ID 2024-514791-40-00 check the CTIS register for the current data. Based on results from a comparative review (Paoletti 2013), we hypothesize that if the toxicity profile and the PK parameters observed…

A pilot study to test the feasibility, safety and efficacy of the addition of the BiTE antibody Blinatumomab to the Interfant-06 backbone in infants with MLL-rearranged acute lymphoblastic leukemia. A collaborative study of the Interfant network.

The primary objective of the study is to assess the safety of 1 course of blinatumomab added to the Interfant-06 backbone in infants with newly diagnosed ALL. The secondary objectives are: • to assess the feasibility• to define the preliminary…