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NCT ID: NCT03362918 Completed - Clinical trials for Polycystic Ovary Syndrome

Polycystic Ovary Syndrome and Exercise

Start date: January 1, 2018
Phase: N/A
Study type: Interventional

Polycystic Ovary Syndrome (PCOS) is a common hormonal disorder characterized by oligo-ovulatory menstrual dysfunction, androgen excess and polycystic ovaries. It affects ten to fifteen percent of reproductive-age women and has been associated with complications in reproductive, metabolic and cardiovascular health. Current Clinical Practice Guidelines suggest exercise and weight loss for PCOS, although their specific roles in improving PCOS-related symptoms are uncertain. Non-pharmacological treatments are appealing to many reproductive age women. There is preliminary evidence that exercise in PCOS may increase menstrual regularity, ovulation, cardiorespiratory fitness, health-related quality of life (HRQOL) and self-esteem, and decrease body fat and insulin resistance. These studies have been limited by short durations and lack of randomization or appropriate control groups. High-intensity interval training (HIIT), which involves brief intervals of near-maximal exercise alternating with lower-intensity exercise, is becoming increasingly popular in the exercise community. In some non-PCOS trials, HIIT resulted in improved cardiovascular fitness and greater fat loss compared with continuous aerobic exercise. No other trials are currently on-going that are comparing HIIT with continuous aerobic exercise training in women with PCOS (as confirmed by searches of the literature and the clinical trials registry maintained by the US NIH).

NCT ID: NCT03362879 Completed - Clinical trials for Parkinson's Disease (PD)

COmedication Study Assessing Mono- and cOmbination Therapy With Levodopa-carbidopa inteStinal Gel

COSMOS
Start date: December 14, 2017
Phase:
Study type: Observational

The purpose of this study is to evaluate treatment of advanced Parkinson's Disease (PD) patients on levodopa-carbidopa intestinal gel (LCIG) monotherapy in a routine clinical setting.

NCT ID: NCT03362723 Completed - Solid Tumors Clinical Trials

A Study to Investigate the Bioequivalence or Relative Bioavailability of Three New Idasanutlin Tablet Variants Following Oral Administration in Participants With Solid Tumors

Start date: November 27, 2017
Phase: Phase 1
Study type: Interventional

This multi-center, open-label, pharmacokinetic study will evaluate the bioequivalence (BE) or relative bioavailability (rBA) of three new idasanutlin-tablet variants compared to the reference tablet formulation following oral administration of a 300 milligrams (mg) dose in participants with solid tumors for whom no further treatment options are available. Following the four administrations of idasanutlin in the BE/rBA cycle of the study (Cycle 1), participants who have no clinically defined progressive disease and who recover from any prior treatment toxicity to Grade less than or equal to (</=) 1 may enter the optional treatment extension phase. This extension phase will continue for additional 28-day cycles or until disease progression or unacceptable toxicity is observed.

NCT ID: NCT03362541 Completed - Multiple Sclerosis Clinical Trials

A Multi-Site Trial of MS INFoRm (Fatigue Management Resource)

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

People with MS commonly experience extreme fatigue that negatively impacts their ability to engage in a full range of daily activities, quality of life, and employment. A new website called MS INFoRm (Multiple Sclerosis: An Interactive Fatigue Management Resource) allows people with MS to take a personalized and active approach to learning about and managing their fatigue. The aims of this study are: 1. To determine to determine whether 3-month use of the MS INFoRm website can reduce the impact of fatigue on daily life among persons with MS. 2. To determine whether 3-month use of the MS INFoRm website results in improvement in self- efficacy/ confidence for managing MS fatigue, self-reported cognitive function, participation and autonomy/ independence, and depression. 3. To determine whether benefits are maintained among the MS INFoRm users after 6-months.

NCT ID: NCT03361956 Completed - Hepatitis B Clinical Trials

An Efficacy, Safety, and Pharmacokinetics Study of JNJ-56136379 in Participants With Chronic Hepatitis B Virus Infection

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

The main purpose of this study is to evaluate efficacy of 24 weeks of study treatment, in terms of changes in hepatitis B surface antigen (HBsAg) levels.

NCT ID: NCT03361891 Completed - Early Ambulation Clinical Trials

WalkMORE: Volunteer Walking Coach Program for Hospitalized Internal Medicine Patients

Start date: June 6, 2018
Phase: N/A
Study type: Interventional

Patients admitted to hospital typically experience periods of decreased activity or bed-rest. This reduced activity level leads to deconditioning - a loss of muscle mass, muscle strength (by 2-5% per day), and muscle shortening. Even among patients who were ambulatory at the time of admission, deconditioning has been linked with deleterious effects, such as increased rates of falls, functional decline, and frailty. Furthermore, it has been suggested that the physiological stresses associated with hospitalization - including deconditioning, as well as sleep deprivation and poor nutrition - makes discharged patients vulnerable to recurrent or new illnesses and to frailty. This physiological stress-induced vulnerability has been coined post-hospital syndrome and is thought to have a role in most hospital readmissions. The investigators hypothesize that by engaging ambulatory patients to walk with trained volunteer coaches, patients will increase their amount of walking, have less deconditioning and functional decline, and consequently, fewer falls. Furthermore, the investigators anticipate that patients who walk with a trained coach will have reduced length-of-stay in hospital and decreased likelihood of readmission. Finally, as shown in other programs trialing health coaches, the investigators anticipate an overall improvement in the patient experience. Our aim is to demonstrate the feasibility of an intentional walking protocol called WalkMORE, which pairs trained volunteer coaches with ambulatory patients admitted to the Internal Medicine unit (4th floor University Hospital), aimed at decreasing deconditioning through increased walking.

NCT ID: NCT03361865 Completed - Clinical trials for UC (Urothelial Cancer)

Pembrolizumab in Combination With Epacadostat or Placebo in Cisplatin-ineligible Urothelial Carcinoma (KEYNOTE-672/ECHO-307)

Start date: December 4, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study was to evaluate the efficacy and safety of pembrolizumab + epacadostat vs pembrolizumab + placebo in participants with cisplatin-ineligible urothelial carcinoma.

NCT ID: NCT03361826 Completed - Clinical trials for Borderline Personality Disorder

Magnetic Seizure Therapy for the Treatment of Borderline Personality Disorder

Start date: October 17, 2017
Phase: N/A
Study type: Interventional

Suicide is a major public health crisis for which effective new interventions are needed. An innovative new brain stimulation technique called magnetic seizure therapy (MST) shows promise for treating suicidal thinking in chronically depressed individuals. Using a high-risk cohort of suicidal patients with borderline personality disorder (BPD) and treatment resistant major depressive disorder (MDD), this study will evaluate the effectiveness of MST for reducing suicidality and depressive symptoms in an open-label clinical trial of up to 15 treatment sessions. Based on research showing that functioning of the dorsolateral prefrontal cortex (DLPFC) may be disrupted in BPD and place individuals at risk for suicide, the DLPFC will be targeted for stimulation. Moderate-to-highly suicidal patients with BPD beginning dialectical behavioural therapy (DBT) will be recruited using a case-control design, comparing individuals receiving MST and DBT with matched patient control group receiving DBT alone.

NCT ID: NCT03361748 Completed - Multiple Myeloma Clinical Trials

Efficacy and Safety Study of bb2121 in Subjects With Relapsed and Refractory Multiple Myeloma

KarMMa
Start date: December 18, 2017
Phase: Phase 2
Study type: Interventional

This is an open label, single-arm, multicenter, Phase 2 study to evaluate the efficacy and safety of bb2121 in subjects with relapsed and refractory multiple myeloma. A leukapheresis procedure will be performed to manufacture bb2121 chimeric antigen receptor (CAR) modified T cells. Prior to bb2121 infusion subjects will receive lymphodepleting therapy with fludarabine and cyclophosphamide.

NCT ID: NCT03361501 Completed - Clinical trials for Hypertriglyceridemia

A Phase 3 STudy of CaPRe in LOwering Very hiGh TriglYcerides (TRILOGY 2)

TRILOGY 2
Start date: February 1, 2018
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to determine the efficacy of CaPre 4 g daily, compared to placebo, in lowering fasting TG levels in subjects with fasting TG levels ≥500 mg/dL and ≤1500 mg/dL (≥5.7 mmol/L and ≤17.0 mmol/L) after 12 weeks of treatment. Approximately 615 subjects will be screened to obtain 245 randomized subjects following a treatment allocation ratio of 2.5:1 (CaPre:placebo).