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NCT ID: NCT03054506 Completed - Constipation Clinical Trials

The Effect of CSP01 on Chronic Idiopathic Constipation and Irritable Bowel Syndrome With Constipation

Start date: March 7, 2017
Phase: N/A
Study type: Interventional

Constipation is a common gastrointestinal motility disorder that is often chronic, negatively affects patients' daily lives. Constipation occurs when bowel movements become difficult or less frequent.This study is being done to study the effectiveness of the hydrogel capsule, CSP01, compared to the active control (carboxymethylcellulose) and placebo (non-medicine sugar pill), to relieve constipation among subjects with chronic idiopathic constipation (CIC) or with irritable bowel syndrome with constipation (IBS-C).

NCT ID: NCT03053427 Completed - Clinical trials for Restless Legs Syndrome (RLS)

A Study of Oral Dosing of Gabapentin Enacarbil in Japanese Restless Legs Syndrome Patients

Start date: March 30, 2017
Phase: Phase 4
Study type: Interventional

The objective of this study was to assess the efficacy of once-daily oral administration of gabapentin enacarbil versus placebo, based on the change in International Restless Legs Syndrome Rating Scale (IRLS) score in participants with moderate-to-severe idiopathic restless legs syndrome. This study also assessed the safety of Gabapentin enacarbil.

NCT ID: NCT03053271 Terminated - Cushing Syndrome Clinical Trials

A Study of ATR-101 for the Treatment of Endogenous Cushing's Syndrome

Start date: April 13, 2017
Phase: Phase 2
Study type: Interventional

This is a Phase 2 multicenter, randomized, double-blind, placebo controlled study of ATR-101 to evaluate the efficacy and safety of orally-administered ATR-101 in adults with endogenous Cushing's syndrome. Following wash-out (if needed), all eligible subjects will enter an open-label intra-subject dose-escalation period of 8 weeks' duration, followed either by a double-blind randomized withdrawal period of 4 weeks' duration (if the subject meets randomization criteria) or by an additional open label dosing period of 4 weeks' duration (if the subject does not meet randomization criteria).It is anticipated that the overall duration of the study per subject will range from approximately 16-22 weeks.

NCT ID: NCT03052439 Completed - Clinical trials for Irritable Bowel Syndrome

Diet Reintroduction Study in Irritable Bowel Syndrome

Start date: July 5, 2017
Phase: N/A
Study type: Interventional

Irritable bowel syndrome (IBS) is the most common gastrointestinal disease, affecting 12% of the US population and up to 20% of the population worldwide. This is a condition that is diagnosed based on specific symptoms of altered bowel habits and abdominal pain, as well as the exclusion of select other GI diseases. IBS not only causes constipation, diarrhea, abdominal cramping, and bloating, it also significantly affects quality of life, overall functioning, and work productivity. The cause of IBS is likely multifactorial, which makes it a difficult disease to treat. However, patients often associate their IBS symptoms with eating a meal. Up to 90% of IBS patients restrict their diet to prevent or improve their symptoms, and patients are increasingly interested in more holistic approaches to disease management. At present, the most persuasive evidence that dietary changes can treat IBS supports a diet low in fermentable carbohydrates (the low FODMAP (fermentable oligo, di, and monosaccharides and polyols) diet). This diet, which is low in certain carbohydrates, has been shown to improve IBS symptoms (particularly abdominal pain and bloating), but can be difficult to follow and quite restrictive. In addition, this diet is not meant to be used as a maintenance diet; patients undergo an elimination phase followed by a reintroduction phase of specific carbohydrate groups as they monitor their symptoms. From the results of our proposed study, the study team hopes to arrive at a modified, less -restrictive version of the low FODMAP diet that is equally effective, and also create a standard protocol that patients can use during this reintroduction phase. Patients with IBS will be recruited into a 13-week trial that would help determine the optimal way in which high FODMAP foods should be introduced. After consent, patients would start on a low FODMAP diet for 14 days, and if their symptoms improve, they would be invited to continue in the study. For 7 days prior to the reintroduction of individual FODMAPs, patients will ingest 1daily servings of a low FODMAP nutrition drink to validate the low FODMAP content of this dietary supplement. If patients do not experience a flare of symptoms with the supplement, they enter the reintroduction period. During this period, subjects would introduce different groups of FODMAPs in a blinded fashion while remaining on an otherwise low FODMAP diet while monitoring their IBS symptoms. At the end of the study period, subjects would be informed of the FODMAPs to which they were sensitive and would meet with a dietitian. At the completion of the study, the investigators would compile the data and determine which FODMAPs were mostly likely to exacerbate IBS symptoms, thus providing the construct for a modified low FODMAP diet, or "low FODMAP-Light." It is hoped that this modified, less restrictive version of the low FODMAP diet would be equally effective for the majority of IBS patients.

NCT ID: NCT03051139 Withdrawn - Clinical trials for Acute Respiratory Distress Syndrome

A Strategy to Improve Implementation of LTVV for Patients w/ ARDS

Start date: June 24, 2013
Phase: N/A
Study type: Interventional

The primary objective of this study is to evaluate whether a multi-component implementation strategy/quality improvement intervention comprised of 1) clinical decision support that couples a natural language processing (NLP) acute respiratory distress syndrome (ARDS) recognition tool with a clinician alert system, and 2) audit and feedback improves the implementation of low tidal volume ventilation (LTVV) for patients with the acute respiratory distress syndrome (ARDS). This will be accomplished with a cluster randomized controlled trial comparing the implementation strategy to usual care

NCT ID: NCT03050268 Recruiting - Pancreatic Cancer Clinical Trials

Familial Investigations of Childhood Cancer Predisposition

SJFAMILY
Start date: April 6, 2017
Phase:
Study type: Observational

NOTE: This is a research study and is not meant to be a substitute for clinical genetic testing. Families may never receive results from the study or may receive results many years from the time they enroll. If you are interested in clinical testing please consider seeing a local genetic counselor or other genetics professional. If you have already had clinical genetic testing and meet eligibility criteria for this study as shown in the Eligibility Section, you may enroll regardless of the results of your clinical genetic testing. While it is well recognized that hereditary factors contribute to the development of a subset of human cancers, the cause for many cancers remains unknown. The application of next generation sequencing (NGS) technologies has expanded knowledge in the field of hereditary cancer predisposition. Currently, more than 100 cancer predisposing genes have been identified, and it is now estimated that approximately 10% of all cancer patients have an underlying genetic predisposition. The purpose of this protocol is to identify novel cancer predisposing genes and/or genetic variants. For this study, the investigators will establish a Data Registry linked to a Repository of biological samples. Health information, blood samples and occasionally leftover tumor samples will be collected from individuals with familial cancer. The investigators will use NGS approaches to find changes in genes that may be important in the development of familial cancer. The information gained from this study may provide new and better ways to diagnose and care for people with hereditary cancer. PRIMARY OBJECTIVE: - Establish a registry of families with clustering of cancer in which clinical data are linked to a repository of cryopreserved blood cells, germline DNA, and tumor tissues from the proband and other family members. SECONDARY OBJECTIVE: - Identify novel cancer predisposing genes and/or genetic variants in families with clustering of cancer for which the underlying genetic basis is unknown.

NCT ID: NCT03050138 Completed - Clinical trials for Postthrombotic Syndrome

Prevalence of Post-Thrombotic Syndrome in Deep-Vein Thrombosis (DVT) Patients Treated With Dabigatran

DABI-PTS
Start date: April 2016
Phase:
Study type: Observational

The primary objective in this cross-sectional study is to assess the prevalence of post-thrombotic syndrome (PTS) in the two treatment arms of the RE-COVER studies (warfarin versus dabigatran). PTS will be assessed by the recently developed Patient Reported Villalta (PRV) Score. Secondary objectives: to assess in both treatment arms the 1. Prevalence of recurrent venous thromboembolism (VTE) after the discontinuation of study treatment. 2. Prevalence of PTS determined by the standard Villalta score. 3. Health related Quality of Life (HRQoL).

NCT ID: NCT03048747 Completed - Clinical trials for Syndrome of Inappropriate Antidiuretic Hormone Secretion

A Multicenter Trial to Investigate the Efficacy and Safety of Tolvaptan in Patients With Hyponatremia in SIADH

Start date: March 2, 2017
Phase: Phase 3
Study type: Interventional

The objective of this study is to investigate the efficacy and safety of tolvaptan based on the change in serum sodium concentration following administration of tolvaptan oral tablets at 7.5 to 60 mg/day for up to 30 days in patients with hyponatremia in the SIADH.

NCT ID: NCT03048279 Active, not recruiting - Clinical trials for Multiple Endocrine Neoplasia Syndromes

Registry for Multiple Endocrine Neoplasia Syndromes: MEN1/MEN2

Start date: September 5, 2001
Phase:
Study type: Observational

Objectives: To contribute new and prospective data to our existing database library for patients with MEN1 and MEN2 at The University of Texas M.D. Anderson Cancer Center.

NCT ID: NCT03047993 Completed - Clinical trials for Myelodysplastic Syndrome

Glutaminase Inhibitor CB-839 and Azacitidine in Treating Patients With Advanced Myelodysplastic Syndrome

Start date: November 15, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

This phase I/II trial studies the side effects of glutaminase inhibitor CB-839 in combination with azacitidine in treating patients with myelodysplastic syndrome that has spread to other places in the body. Glutaminase inhibitor CB-839 and azacitidine may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.