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NCT ID: NCT03551782 Completed - Clinical trials for Castration-Resistant Prostatic Neoplasms

A Study of Cetrelimab (JNJ-63723283), a Programmed Cell Death Receptor-1 (PD-1) Inhibitor, Administered in Combination With Apalutamide in Participants With Metastatic Castration-Resistant Prostate Cancer

Start date: June 28, 2018
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety of the combination of cetrelimab, with apalutamide and to define a population of participants with metastatic castration-resistant prostate cancer (mCRPC) who respond to treatment with the combination of cetrelimab and apalutamide.

NCT ID: NCT03551496 Completed - Clinical trials for Critical Limb Ischemia

The DES BTK Vascular Stent System vs PTA in Subjects With Critical Limb Ischemia

SAVAL
Start date: August 31, 2018
Phase: Phase 3
Study type: Interventional

Single phased global, prospective, multicenter clinical trial designed to demonstrate a superior patency rate and acceptable safety in below the knee arteries with lesions treated with the DES BTK Vascular Stent System vs. percutaneous transluminal angioplasty (PTA).

NCT ID: NCT03549416 Recruiting - Atopic Dermatitis Clinical Trials

BioDay Registry: Data Collection Regarding the Use of New Systemic Treatment Options in Patients With Atopic Dermatitis

BioDay
Start date: January 1, 2018
Phase:
Study type: Observational [Patient Registry]

The BioDay Registry aims to address the need for daily practice data regarding the effectiveness and safety of new systemic treatment options (like biologics and Janus kinase inhibitors) in patients with atopic dermatitis and effect on other atopic comorbidities in a multicenter setting. The registry already consists of several additional modules concerning atopic comorbidities, like food allergy and asthma, and a module for conjunctivitis during biologic treatment.

NCT ID: NCT03548987 Completed - Obesity Clinical Trials

Research Study Investigating How Well Semaglutide Works in People Suffering From Overweight or Obesity

STEP 4
Start date: June 4, 2018
Phase: Phase 3
Study type: Interventional

This study will look at the change in participant's body weight from the start to the end of the study. This is to compare the effect on body weight in people taking semaglutide (a new medicine) and people taking "dummy" medicine. In addition to taking the medicine, the participant will have talks with study staff about healthy food choices, how to be more physically active and what a participant can do to lose weight. The participant will get semaglutide for the first 20 weeks. Then the participant will get either semaglutide or "dummy" medicine - which treatment the participant gets after the 20 weeks is decided by chance. The participants will need to take 1 injection once a week. The study medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm. The study will last for about 1.5 years.

NCT ID: NCT03548675 Completed - Clinical trials for Depressive Disorder, Major

Pharmacogenetics Informed Tricyclic Antidepressant Dosing (PITA)

PITA
Start date: May 23, 2018
Phase: Phase 4
Study type: Interventional

Tricyclic Antidepressants (TCA's) are the cornerstone of treatment for patients with severe Major Depressive Disorder (sMDD). Current dosing is guided by repeated measurements of blood levels. Compared to patients with a normal metabolization function, for those with increased CYP450 enzyme activity it takes longer to reach a therapeutic drug level. The consequent delay of drug efficacy is associated with a prolonged treatment period, increased risk of suicidal behaviour and eventually lower remission rates. For those with reduced CYP450 activity higher rates of side effects are expected. An innovative TCA dosing strategy, taking the genetic variants of CYP2D6 and CYP2C19 into account may help to reduce the above mentioned problems. Up till now, the current guidelines for CYP450 pharmacogenetics based TCA dosing have not been systematically evaluated for effectiveness and cost-effectiveness in larger groups of patients. Such evaluation is necessary before broad implementation of these guidelines can be advocated. In the present study 200 patients with sMDD who are treated with nortriptyline, clomipramine or imipramine are randomized over two strategies: dosing based both on CYP450-genotype and blood level measurements and dosing as usual (standard doses plus blood levels). We hypothesize that genotype informed dosing results in faster attainment of therapeutic drug levels, lower rates of side effects, earlier symptom relief and lower levels of health- and working related costs.

NCT ID: NCT03548220 Completed - Clinical trials for Pyruvate Kinase Deficiency

A Study to Evaluate Efficacy and Safety of AG-348 in Not Regularly Transfused Adult Participants With Pyruvate Kinase Deficiency (PKD)

Start date: August 9, 2018
Phase: Phase 3
Study type: Interventional

Study AG348-C-006 evaluated the efficacy and safety of orally administered AG-348 as compared with placebo in participants with pyruvate kinase (PK) deficiency, who were not regularly receiving blood transfusions. Participants were randomized 1:1 to receive either AG-348 or a matching placebo.

NCT ID: NCT03547362 Completed - Clinical trials for Protein Digestion Kinetics

Real-time Amino Acid Profiling

RAP
Start date: May 30, 2018
Phase: N/A
Study type: Interventional

This study was designed to obtain information about the effect of new combinations of dairy proteins, in small servings with high protein concentrations, on postprandial amino acid kinetics in blood in an older population.

NCT ID: NCT03545061 Recruiting - Large Bowel Polyp Clinical Trials

Dutch National Prospective EMR Cohort

DN-PEC
Start date: August 6, 2018
Phase:
Study type: Observational [Patient Registry]

A Prospective Study: Longterm Follow Up until S2 (2nd surveillance) at 18 months after EMR for Large Flat/Sessile Colonic Polyps.

NCT ID: NCT03541174 Completed - Clinical trials for Resistant Hypertension

A Research Study to Show the Effect of Aprocitentan in the Treatment of Difficult to Control (Resistant) High Blood Pressure (Hypertension) and Find Out More About Its Safety

PRECISION
Start date: June 18, 2018
Phase: Phase 3
Study type: Interventional

The goal of this clinical trial is to show the blood pressure lowering effect of aprocitentan, a new drug, when added to other anti-hypertensive drugs of patients with difficult to control (resistant) high blood pressure (hypertension), and to show that blood pressure reduction is kept for long period of time.

NCT ID: NCT03541083 Active, not recruiting - ALL, Adult Clinical Trials

Blinatumomab Added to Prephase and Consolidation Therapy in Precursor B-acute Lymphoblastic Leukemia in Adults.

HOVON146ALL
Start date: June 4, 2018
Phase: Phase 2
Study type: Interventional

Blinatumomab is a new active bispecific monoclonal antibody for treatment of lymphoid malignancies, including ALL (acute Lymphoblastic Leukemia ) whose activity for remission induction needs to be explored in combination with standardized treatment in order to improve outcome of this disease which is still lethal in most adult patients. Ultimate proof of efficacy resides in an increase of reaching MRD ( minimal residual disease) negativity, prolongation of that response, and long-term survival. Since hematological response rate in adult ALL is high already and defining long-term survival in a large clinical trial takes many years, this trial aims to improve the strength of the MRD response as defined by achieving complete MRD negative response (ie, < 10^-4) after the first consolidation phase including blinatumomab. This MRD response will be assessed by Real-Time Quantitative Polymerase Chain Reaction (RQ-PCR) analysis of patient-specific Ig/TCR (T-cell receptor ) gene rearrangements. When MRD data are missing, MRD positivity will be assumed. Although younger (up to 40 years of age) patients are treated more intensively than older patients (older than 40 years of age), the investigational questions concerning blinatumomab can be examined in both subgroups as both younger and older patients receive the same type of chemotherapy courses with dose adjustments for chemotherapeutic agents only for patients above 60 years of age.