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NCT ID: NCT03394924 Completed - Clinical trials for Primary Biliary Cholangitis

A Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects With Primary Biliary Cholangitis

Start date: December 27, 2017
Phase: Phase 2
Study type: Interventional

A randomized, double-blind study to assess the safety, tolerability, PK and efficacy of EDP-305 in subjects with primary biliary cholangitis

NCT ID: NCT03393871 Completed - Clinical trials for Coronary Artery Disease

Myocardial Mass Determination by FFRct and Absolute Coronary Blood Flow

MyoMass
Start date: February 1, 2018
Phase:
Study type: Observational

The background for performing the present study is to compare the mass calculations by CT scanning and by invasive absolute blood flow measurements and thereby corroborating both methods.

NCT ID: NCT03393780 Completed - Clinical trials for Controlled Ovarian Stimulation

Study to Assess the Patterns of Use of REKOVELLE® in Naïve Women Undergoing In Vitro Fertilisation or Intracytoplasmic Sperm Injection Procedures

PROFILE
Start date: March 16, 2018
Phase:
Study type: Observational

The purpose of this study is to monitor the use in routine clinical practice of REKOVELLE®. This study will collect information from patients who never underwent previous in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI) treatments for up to three consecutive treatment cycles. The ovarian stimulation protocol with REKOVELLE®, a new recombinant human Follicle Stimulating Hormone (FSH) prescribed for ovarian stimulation, is individualised with a dosing regimen that is based on two parameters: the body weight and the level of a hormone, the Anti Müllerian Hormone, (AMH), a parameter used to predict how the ovaries will respond to the ovarian stimulation.

NCT ID: NCT03392896 Completed - Clinical trials for Primary Hyperoxaluria

Study of DCR-PHXC-101 in Normal Healthy Volunteers and Patients With Primary Hyperoxaluria

Start date: December 6, 2017
Phase: Phase 1
Study type: Interventional

This is a double-blind, placebo-controlled, dose escalation trial of DCR-PHXC in Healthy Volunteers (HVs) and patients with Primary Hyperoxaluria (PH). Once safety has been established in HV, PH patients with a confirmed diagnosis of PH1 and PH2 will be enrolled across multiple dosing cohorts. The study design will allow enrollment of PH patient cohorts at a given dose level once safety has been demonstrated in HV at that dose level. The study will be conducted in two parts: Part A: Single ascending dose (SAD) in HV; Part B: SAD in patients with PH1 and PH2 (lagging Part A by 1 dose level cohort).

NCT ID: NCT03387761 Completed - Clinical trials for Urothelial Carcinoma

Neo-Adjuvant Bladder Urothelial Carcinoma COmbination-immunotherapy

NABUCCO
Start date: January 15, 2018
Phase: Phase 1
Study type: Interventional

In cohort 1 of this study, we used an attenuated schedule of neoadjuvant ipilimumab and nivolumab. In the multicenter extension (cohort 2), 30 patients were randomized between two neoadjuvant treatment schemes, both based upon an attenuated schedule of neoadjuvant ipilimumab and nivolumab.Both cohorts are completed.

NCT ID: NCT03386058 Completed - Neuralgia Clinical Trials

Examining Carryover Effect in Patients Treated witH Spinal cOrd Stimulation (ECHO)

ECHO
Start date: January 31, 2018
Phase: N/A
Study type: Interventional

Spinal cord stimulation is a minimally invasive surgical treatment for severe, chronic, neuropathic pain that is refractory to conventional treatment. The treatment consists of an electrode implanted in the epidural space of the spinal cord, either via a percutaneous approach (using the so-called percutaneous leads) or via a surgical (hemi-) laminectomy (using the so-called surgical leads or plate leads). It is a well-known clinical observation that when activating or deactivating SCS stimulation, there is a variable interval before the patient perceives a clinical effect of the change. This variation goes by different names (carryover, echo, after effect, etc.) and might be dependent on the clinical condition and treatment duration. To our knowledge only very little research has been published on the topic of carryover effects; a recent study showed that the interval is highly variable between patients. While patients may experience immediate pain relief at the onset of SCS treatment, the effect in patients with a long-term SCS treatment history may have different characteristics, possibly due to ongoing changes in the nervous system. The aim of this pilot study is to lay the foundation for investigating the carryover effects in spinal cord stimulation. This will be carried out in a mixed population of patients with different indications for SCS, and with different treatment durations. Patients will be asked to deactivate their device via their remote control or with a magnet in a standardized fashion. They will be asked to reactivate the device when specific parameters have been met, and the time is recorded.

NCT ID: NCT03385031 Completed - Breast Cancer Clinical Trials

Prospective Validation of 3D Dose Metrics as Selection Criteria for Adaptive Radiotherapy in Breast Cancer Patients

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

In a retrospective study the investigators defined quantitative action levels based on dose and volume measures for adaptive radiation therapy in breast cancer patients (Zegers et al. Acta Oncol 2017). The aim of this study is to validate these parameters in a prospective study.

NCT ID: NCT03384966 Completed - Clinical trials for Stable Coronary Artery Disease

A Medical Research Study to Evaluate the Effects of ACT-246475 in Adults With Coronary Artery Disease

Start date: January 24, 2018
Phase: Phase 2
Study type: Interventional

The goal of this study is to find out if a drug called selatogrel (ACT-246475) can prevent platelets from binding together when administered by an injection under the skin in the thigh or in the belly. Another goal is to know how fast and for how long selatogrel (ACT-246475) works and if there is a difference if the drug is injected in the thigh or in the belly. This study will also help to find out more about the safety of this new drug.

NCT ID: NCT03384654 Completed - Clinical trials for Precursor Cell Lymphoblastic Leukemia-Lymphoma

A Study to Evaluate the Efficacy and Safety of Daratumumab in Pediatric and Young Adult Participants Greater Than or Equal to (>=)1 and Less Than or Equal to (<=) 30 Years of Age With Relapsed/Refractory Precursor B-cell or T-cell Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma

Start date: May 14, 2018
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy of daratumumab in addition to standard chemotherapy in pediatric participants with relapsed/refractory B-cell acute lymphoblastic leukemia (ALL)/lymphoblastic lymphoma (LL) and T-cell ALL/LL as measured by the complete response (CR) rate.

NCT ID: NCT03384030 Completed - Emotional Stress Clinical Trials

Exploration of the Modulation of Skin Microbiota and Odor Components by Introduction of Stress in Healthy Male Subjects

MOIST
Start date: October 31, 2017
Phase: N/A
Study type: Interventional

In the MOIST study it will be assessed whether the adapted Sternberg short-term working memory task (STMST) is an effective method to induce malodor formation by emotional stress, as assessed by expert assessments of stress-induced malodor formation in the armpits of 30 healthy male volunteers. Before, during and after being exposed to the adapted version of the STMST, saliva will be collected to determine cortisol levels, subjects have to rate their momentary feelings of anxiety and embarrassment and heart rate variability will be monitored continuously with a wireless signal transmission device. Before and after exposure to the adapted STMST, malodor levels will be assessed by two expert judges, axillary volatiles will be collected by cup scrubbing and microbiota samples will be taken to determine microbial species.