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NCT ID: NCT04204408 Completed - Healthy Volunteers Clinical Trials

A Research Study Investigating Mim8 in People With Haemophilia A

FRONTIER1
Start date: January 10, 2020
Phase: Phase 2
Study type: Interventional

This study is investigating how Mim8 works in people with haemophilia A, who either have inhibitors or do not have inhibitors. Mim8 is a new medication that will be used for prevention of bleeding episodes. Mim8 works by replacing the function of the missing clotting factor VIII (FVIII). Mim8 will be injected with a thin needle in the skin of the stomach, using a pen-injector. The study will last for up to 44 months. It consists of a main phase (part 1 and part 2) and an extension phase. In part 1, participants will be injected only once with either Mim8 or a "dummy" medicine (placebo) - which one will be decided by chance. In part 2 and the extension phase participants will get an Mim8 injection weekly or monthly.

NCT ID: NCT04203810 Completed - Cough Clinical Trials

Effectiveness and Tolerability of Ectoin® Mouth and Throat Spray Althaea Honey (ERS09)

Start date: January 14, 2020
Phase: N/A
Study type: Interventional

The aim of this multicentre, actively controlled, randomized, open label, parallel group, prospective, comparator study is to collect data on the clinical effectiveness and tolerability of the medical device ERS09 compared to a well-established comparator spray in the symptomatic treatment of sore throat due to acute pharyngitis and dry cough.

NCT ID: NCT04203797 Completed - Asthma Clinical Trials

A Study to Evaluate the Effect of Dupilumab on Exercise Capacity in Adult Patients With Asthma

Start date: July 16, 2020
Phase: Phase 4
Study type: Interventional

The primary objective of the study is to demonstrate that dupilumab treatment improves exercise capacity in patients with moderate-to-severe asthma. The secondary objectives of the study are: - To demonstrate that dupilumab treatment increases physical activity of daily living in patients with moderate-to-severe asthma - To demonstrate that dupilumab treatment improves pre- and post-exercise lung function in patients with moderate-to-severe asthma

NCT ID: NCT04203667 Completed - Polyp of Colon Clinical Trials

EndoRotor® Endoscopic Mucosal Resection System for the Colon

Start date: April 18, 2018
Phase: N/A
Study type: Interventional

The EndoRotor® is intended for use (USA labeling) in endoscopic procedures by a trained gastroenterologist to resect and remove tissue, not intended for biopsy, of the gastrointestinal (GI) system including post-endoscopic mucosal resection (EMR) tissue persistence with a scarred base and residual tissue from the peripheral margins following EMR. In this trial investigators will conduct a post-market, prospective, non-randomized, multi-center study for the treatment of subjects with the need for resection of recurrent flat or sessile colorectal lesions where EndoRotor is the primary resection modality of persistent adenoma with a scarred base.

NCT ID: NCT04202692 Completed - Clinical trials for Gastro Esophageal Reflux

Effect of a Combination Oral Formulation of Hyaluronic Acid, Chondroitin Sulphate and Magnesium Trisilicate in Patients With Gastro-Esophageal Reflux Disease Not Fully Satisfied With Their Treatment

Start date: November 5, 2019
Phase: N/A
Study type: Interventional

This is a post-market, multi-center, double-blind, placebo-controlled, randomized, cross-over study with GERDOff Plus added on top of the current PPI treatment in patients with GERD. The aim of the study is to evaluate the performance of GERDOff Plus, a class III medical device, consisting in a hyaluronic acid, chondroitin sulphate and magnesium trisilicate, in addition to the PPIs, in patients with GERD not fully satisfied with their current treatment with PPIs. Patients will receive either GERDOff Plus or placebo q.i.d. for 21 days followed by a wash-out period of 3 weeks. After the wash-out period, the patients will receive either placebo or GERDOff Plus respectively

NCT ID: NCT04202159 Completed - Seizures Clinical Trials

A Study to Evaluate the Effectiveness of Perampanel as Only Add-on Treatment in Participants With Primary or Secondarily Generalized Tonic-clonic Seizures

Start date: January 21, 2020
Phase:
Study type: Observational

The primary purpose of this study is to investigate the effectiveness reflected by the retention rate of perampanel as the only add-on treatment in adult participants with primary generalized tonic-clonic (PGTC) or secondarily generalized tonic-clonic (SGTC) seizures based on focal or idiopathic generalized epilepsy in a non-interventional (observational) setting.

NCT ID: NCT04202029 Completed - Clinical trials for Percutaneous Endoscopic Gastrostomy (PEG)

Additional Benefit of Thoracic Impedance Monitoring (TIM) for Propofol-sedation Monitoring During PEG Placement

TIMPEG
Start date: November 4, 2019
Phase: N/A
Study type: Interventional

The present study is a randomized, prospective, single-blinded study. A total of 172 patients presenting for percoutaneous endoscopic gastrostomy (PEG) under sedation will be included according to the statistical sample size calculation. Patients will be randomized to either group 1- standard monitoring (pulseoxymetry and non-invasive blood preassure monitoring) or group 2- standard monitoring and thoracic impedance measurement during Propofol-based sedation for PEG. Episodes of Hypoxia are documented and compared in both groups. Statistical analysis will be done in cooperation with the statistical biomedical institute oft he university hospital in Frankfurt.

NCT ID: NCT04200430 Completed - Healthy Clinical Trials

Effect of Meal Composition and Timing on Evobrutinib Bioavailability

Start date: April 15, 2019
Phase: Phase 1
Study type: Interventional

This study will evaluate the Pharmacokinetics (PK) of the Phase II tablet formulation of Evobrutinib under fasted conditions, within 30 minutes after start of a light meal, one hour prior to start of a low-fat meal, and 2 hours after start of a low-fat meal.

NCT ID: NCT04198558 Completed - Chronic Pain Clinical Trials

A Study of the Safety, Tolerability and Pharmacokinetics of MEDI0618 in Healthy Volunteers

Start date: November 29, 2019
Phase: Phase 1
Study type: Interventional

This is a randomised, placebo-controlled study of the safety and tolerability of single doses of MEDI0618 in healthy volunteer subjects.

NCT ID: NCT04196283 Completed - Clinical trials for Advanced Solid Tumors Cancer

A Study to Determine the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ABBV-368 Plus Tilsotolimod and Other Therapy Combinations in Participants With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma

Start date: January 22, 2020
Phase: Phase 1
Study type: Interventional

The main objective of this study is to assess safety, tolerability, and pharmacokinetics (PK) of ABBV-368 plus tilsotolimod; ABBV-368 plus tilsotolimod and nab-paclitaxel; and ABBV-368 plus tilsotolimod, nab-paclitaxel, and ABBV-181 in participants with recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC).