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NCT ID: NCT04185883 Recruiting - Clinical trials for Advanced Solid Tumors

Sotorasib Activity in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101)

Start date: December 17, 2019
Phase: Phase 1
Study type: Interventional

To evaluate the safety and tolerability of sotorasib administered in investigational regimens in adult participants with KRAS p.G12C mutant advanced solid tumors.

NCT ID: NCT04182841 Recruiting - COPD Clinical Trials

RheOx Registry Study in Europe

Start date: January 9, 2020
Phase: N/A
Study type: Interventional

Post-market clinical study (registry study) to collect post-market safety and clinical utility data in European patients with chronic bronchitis treated with RheOx.

NCT ID: NCT04173273 Recruiting - Crohn's Disease Clinical Trials

A Study Evaluating the Efficacy and Safety of Oral Etrasimod in the Treatment of Adult Participants With Moderately to Severely Active Crohn's Disease

CULTIVATE
Start date: January 6, 2020
Phase: Phase 3
Study type: Interventional

This is a Phase 2/3 study that comprises 5 substudies designed to evaluate the efficacy, safety, and tolerability of oral etrasimod as therapy in adult participants with moderately to severely active Crohn's disease (CD) who are refractory or intolerant to at least 1 of the current therapies for CD (ie, corticosteroids, immunosuppressants, or biologics). The overall duration of this study is up to 282 weeks, inclusive of the Screening Period, Treatment Period of up to 274 weeks (Induction, Extension or Maintenance, and Long-term Extension Periods), and the 4-Week Follow-Up Period for safety assessment.

NCT ID: NCT04165486 Recruiting - Clinical trials for Multiple System Atrophy

Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ION464 Administered to Adults With Multiple System Atrophy (HORIZON)

HORIZON
Start date: July 21, 2022
Phase: Phase 1
Study type: Interventional

The primary objectives are to evaluate the safety and tolerability of multiple doses of ION464 administered via intrathecal (IT) injection (Part 1) and to evaluate the long-term safety and tolerability of ION464 (Part 2) in participants with multiple system atrophy (MSA). The secondary objectives are to evaluate the pharmacodynamic (PD) effect of ION464 on the level of a potential biomarker of target engagement (Parts 1 and 2) and to evaluate the pharmacokinetic (PK) profile of ION464 in serum (Part 1).

NCT ID: NCT04150406 Recruiting - Endometriosis Clinical Trials

Flexofytol® for the Treatment of Endometriosis- Associated Pain

ENDOFLEX
Start date: October 22, 2019
Phase: N/A
Study type: Interventional

Endometriosis is a benign disease that affects 6-10% of women of reproductive age. The wide range of symptoms observed in patients with endometriosis is due to implantation of endometrial tissue outside the uterine cavity. This ectopic endometrium is subjected to cyclic changes similar to that of eutopic endometrium. Typically, ectopic lesions are found in the pelvis, notably on the ovaries in the form of cysts (endometriomas), as well as the rectouterine and vesicouterine pouch. Lesions have also been described in other parts of the abdomen and in other locations outside the abdominal cavity. Although endometriosis has also been described in asymptomatic patients, possible symptoms range from mild to severe pain presenting itself as dysmenorrhea, dyspareunia, or dyschezia, or as infertility. Since the clinical picture varies, the treatment of this disease has become quite personalized. Many studies conducted over the past several years have presented different treatment options for the symptoms caused by endometriosis. Turmeric, which is won from the rootstalks of Curcuma longa, has more than 300 biologically active elements. One of the three main curcuminoids that are derived from turmeric, is curcumin. Several in-vitro and animal studies have described anti-oxidant, anti-inflammatory and anti-angiogenic effects of curcumin. The main objective for the treatment of endometriosis patients is symptom relief. Treatment options include analgesic therapies, hormonal therapies, laparoscopic surgery or a combination of these. For patients who refuse hormonal therapies however, conservative treatment options are limited. Curcuma is a substance that has been in use for centuries, especially in ayurvedic and Traditional Chinese Medicine for the treatment of various symptoms, notably for pain alleviation in inflammatory illnesses. Several recently published studies have shown very promising results of Flexofytol for pain alleviation in patients with osteoarthritis, due to its anti-inflammatory and anti-oxidant properties. Due to these properties of curcuma, we aim to analyse if curcuma capsules, sold by the pharmaceutical company Tilman under the name Flexofytol®, can be used to alleviate symptoms in patients suffering from endometriosis.

NCT ID: NCT04142437 Recruiting - Clinical trials for Locally Advanced or Metastatic Solid Tumor Harboring an NTRK Gene Fusion

Study to Learn More About the Safety and Effectiveness of the Drug VITRAKVI During Routine Use in Patients With TRK Fusion Cancer Which is Locally Advanced or Spread From the Place Where it Started to Other Places in the Body

ON-TRK
Start date: April 3, 2020
Phase:
Study type: Observational

In this observational study researcher want to learn more about the effectiveness of drug VITRAKVI (generic name: larotrectinib) and how well the drug is tolerated during routine use in patients with TRK fusion cancer which is locally advanced or spread from the place where it started to other places in the body. TRK fusion cancer is a term used to describe a variety of common and rare cancers that are caused by a change to the NTRK (Neurotrophic Tyrosine Kinase) gene called a fusion. During this fusion, an NTRK gene joins together, or fuses, with a different gene. This joining results in the activation of certain proteins (TRK fusion proteins), which can cause cancer cells to multiply and form a tumor. VITRAKVI is an approved drug that blocks the action of the NTRK gene fusion. This study will enroll adult and paediatric patients suffering from a solid tumor with NTRK gene fusion for whom the decision to treat their disease with VITRAKVI has been made by their treating physicians. During the study, patients' medical information such as treatment information with VITRAKVI, other medication or treatments, changes in disease status and other health signs and symptoms will be collected within the normal medical care by the treating doctor. Participants will be observed over a period from 24 to 60 months.

NCT ID: NCT04142164 Recruiting - Clinical trials for Diabetic Macular Edema

Computer-based Tutorial and Automated Speech Recognition for Intravitreal Drug Injections

Start date: October 24, 2019
Phase: N/A
Study type: Interventional

Evaluation if a computer-based tutorial ("MacInfo" tool) improves the patients' knowledge about intravitreal drug injections, associated risks, and the underlying diseases of treatment-naive patients.

NCT ID: NCT04140747 Recruiting - Clinical trials for Microbial Colonization

Transfer of Strictly Anaerobe Microbes From Mother to Child

TRAMIC
Start date: October 7, 2016
Phase:
Study type: Observational

This study aims to investigate the changes in the microbiota at different body sites in late pregnancy, in comparison with non-pregnant women, with particular emphasis on archaea, and to identify possible maternal-to-child transfer routes for acquisition of strictly anaerobic microorganisms by analyzing the gut microbiota of new born infants (delivered vaginally or by C-section).

NCT ID: NCT04138186 Recruiting - Clinical trials for Irritable Bowel Syndrome With Diarrhea (IBS-D)

G-PUR® for Symptomatic Treatment in Irritable Bowel Syndrome With Diarrhea

Start date: October 2, 2019
Phase: N/A
Study type: Interventional

A randomized, double-blind, placebo-controlled pilot study in patients with IBS-D according to Rome IV criteria evaluating the clinical efficacy and safety of oral administration of 2g G-PUR® tid compared to placebo in a cohort of 30 patients over an active treatment period of 12 weeks.

NCT ID: NCT04136587 Recruiting - Clinical trials for Inflammatory Bowel Diseases

The Bacterial Secretome in IBD

Start date: June 1, 2019
Phase: N/A
Study type: Interventional

Secreted bacterial effectors produced by the intestinal microbiota are in part responsible for the proinflammatory effect of the fecal content in inflammatory bowel disease (IBD) patients.