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NCT ID: NCT03626012 Completed - Clinical trials for Amyotrophic Lateral Sclerosis

A Study to Assess the Safety, Tolerability, and Pharmacokinetics of BIIB078 in Adults With C9ORF72-Associated Amyotrophic Lateral Sclerosis

Start date: September 10, 2018
Phase: Phase 1
Study type: Interventional

The primary objective of this study is to evaluate the safety and tolerability of BIIB078 in adults with C9ORF72-Amyotrophic Lateral Sclerosis (ALS). The secondary objectives of this study are to evaluate the pharmacokinetic profile of BIIB078 and to evaluate the effects of BIIB078 on clinical function. As the first-in-human study, the study enrolls a small number of participants in each cohort. Every participant in a cohort is treated with the same dose or placebo. The study is designed to evaluate and confirm the safety of each dose before enrolling and exposing new participants to a higher dose in the next cohort.

NCT ID: NCT03625869 Completed - STEMI Clinical Trials

Pressure-controlled Intermittent Coronary Sinus Occlusion (PiCSO) in Acute Myocardial Infarction

PiCSO-AMI-I
Start date: July 25, 2019
Phase: N/A
Study type: Interventional

The objective of this study is to assess efficacy and safety of Pressure-controlled intermittent Coronary Sinus Occlusion (PiCSO) therapy started post flow restoration but prior to stenting during percutaneous coronary intervention (PCI) compared to standard PCI in the setting of acute ST-segment elevation anterior myocardial infarction (STEMI).

NCT ID: NCT03625141 Completed - Metastatic Melanoma Clinical Trials

A Study Evaluating the Safety and Efficacy of Cobimetinib Plus Atezolizumab in BRAFV600 Wild-type Melanoma With Central Nervous System Metastases and Cobimetinib Plus Atezolizumab and Vemurafenib in BRAFV600 Mutation-positive Melanoma With Central Nervous System Metastases

Start date: December 13, 2018
Phase: Phase 2
Study type: Interventional

This study will evaluate the efficacy and safety of cobimetinib plus atezolizumab in participants with BRAFV600 wild-type melanoma with central nervous system (CNS) metastases and of cobimetinib plus atezolizumab and vemurafenib in BRAFV600 mutation-positive melanoma patients with CNS metastases.

NCT ID: NCT03624699 Completed - Clinical trials for Glaucoma, Open-Angle

Investigation of the iStent Inject® Devices in Open-Angle Glaucoma

Start date: April 25, 2018
Phase: N/A
Study type: Interventional

The aim of this study is to evaluate the safety and intraocular pressure (IOP) lowering effect of two iStent inject devices in combination with cataract surgery in patients with mild-to-moderate open-angle glaucoma.

NCT ID: NCT03624114 Completed - Pituitary Adenoma Clinical Trials

Prediction of Sphenoid Septation in MRI Compared With CT and Intraoperative Findings During Endoscopic Pituitary Adenoma Surgery

Scope
Start date: January 1, 2018
Phase:
Study type: Observational

To investigate whether MRI is able to predict the exact anatomy and topography of the sphenoid sinus and its relationship to the sellar, parasellar und paraclinoid region and where CT yields more detailed information for the surgeon before trans-sphenoidal pituitary adenoma surgery.

NCT ID: NCT03623997 Completed - Clinical trials for Iron Deficiency Anemia

Measuring Erythrocyte Iron Incorporation From Different Dosing Regimens in Anemic Women

Start date: October 10, 2017
Phase:
Study type: Observational

Iron-deficient anaemic subjects are likely to benefit most from oral iron supplements, but supplementation schedules vary widely in clinical practice, absorption is low and compliance is poor due to mild gastrointestinal side effects. The investigators will compare iron absorption from labeled oral iron doses of 100mg and 200mg administered either on two consecutive days or on alternate days in young anemic women.

NCT ID: NCT03623178 Recruiting - Clinical trials for Substance Use Disorders

Assertive Community Treatment for Patients Suffering From Substance Use Disorders

Start date: December 1, 2017
Phase:
Study type: Observational

According to the World Health Organization the population suffering from addiction problems is increasing. This population is characterized by multiple needs at the medico-psychosocial level. However, some of these patients, a particular subgroup that we are going to be interested in the so-called "high need" user group, find it difficult to access and stay in outpatient treatment programs. Persons with substance use disorder often present a chaotic use of the health system, including a high number of hospitalizations in times of crisis. These individuals also show very low utilization of health care services, accompanied by social marginalization. This can be related to relapses and poor social functioning. A high number of relapses occur particularly at the end of hospitalization. Community Interventions, such as Assertive Community Treatment (ACT) should increase the adherence of these patients to treatment by accompanying them in the community and helping them during sensitive and crisis periods. One of the objectives of the study is to evaluate the impact of ACT on the time until service disengagement, measuring treatment adherence. The secondary objectives of this study will be to see the effect of ACT on duration and type of hospitalizations, as well as the number of emergency room visits. The investigators will focus on the impact of ACT on the participant's medico-psycho-social network, substance use and other psychological variables. The investigators will also evaluate his or her psychiatric symptoms and global and social functioning. Life satisfaction and satisfaction with the care received will also be measured. The investigators will compare the population treated with ACT with sex, age and substance-matched controls which do not respond to ACT inclusion criteria chosen from new admissions of our addictology consultation. The study will investigate this through questionnaires at the beginning of care, at three months, six months and 12 months after the start of the ACT intervention.

NCT ID: NCT03622593 Completed - Clinical trials for Diabetic Macular Edema

A Study to Evaluate the Efficacy and Safety of Faricimab (RO6867461) in Participants With Diabetic Macular Edema

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

This study will evaluate the efficacy, safety, and pharmacokinetics of faricimab administered at 8-week intervals or as specified in the protocol following treatment initiation, compared with aflibercept once every 8 weeks (Q8W), in participants with diabetic macular edema (DME).

NCT ID: NCT03621254 Recruiting - Spinal Cord Injury Clinical Trials

Investigation Into Optimal FES Training Characteristics After Spinal Cord Injury

Start date: January 7, 2019
Phase: N/A
Study type: Interventional

The aim of this study is to investigate two different modalities of functional electrical stimulation (FES) leg exercise in patients with spinal cord injury (SCI). The primary outcomes being compared are 1. FES-induced leg aerobic fitness, and 2. FES-induced leg strength. There will be two FES-leg training groups, and sub-acute patients with SCI will be randomised between the groups - high-short [HI-SHORT] and low-long [LO-LONG]. Both groups (n=10 per group) will exercise on the Hasomed RehaStimâ„¢ exercise ergometer for 6-8 weeks, three-four times per week (24 therapy sessions). [HI-SHORT] will perform 10 x 2-min of high-intensity interval training with a recovery of 1-2 min between exercise bouts. [LO-LONG] will perform 20+ min of continuous exercise at a low-moderate exercise intensity. Exercise intensity for [HI-SHORT] and [LO-LONG] will be titrated by neuromuscular stimulation characteristics. The primary outcomes will be assessed before training commences and after 6-8 weeks of training has been completed.

NCT ID: NCT03620669 Active, not recruiting - NSCLC Stage IV Clinical Trials

1st Line Durvalumab in PS 2 NSCLC Patients

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

The aim of the trial is to assess efficacy and safety of the treatment with durvalumab in PS 2 patients with treatment-naïve, locally advanced or metastatic, PD-L1 positive NSCLC who are considered unsuitable for combination platinum-containing therapy.