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NCT ID: NCT03379428 Active, not recruiting - Breast Neoplasms Clinical Trials

Trial of Ibrutinib Plus Trastuzumab in HER2-amplified Metastatic Breast Cancer

Start date: November 29, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

This is a Phase I/II, open-label dose-escalation study designed to evaluate the maximum tolerated dose (MTD) and dose-limiting side effects of ibrutinib (560 or 840 or 420 mg daily oral dose), given in combination with trastuzumab administered through the vein, in patients with HER2-amplified Metastatic Breast Cancer that has gotten worse after prior therapy with ado-trastuzumab emtansine (T-DM1).

NCT ID: NCT03378765 Active, not recruiting - Obesity Clinical Trials

Gut Microbiota, Short Chain Fatty Acids, and Adiposity Across The Epidemiological Transition

Start date: January 2, 2018
Phase:
Study type: Observational

The objective of this study is to define associations between gut microbiota, SCFAs and obesity in populations spanning the epidemiologic transition, and explore mechanisms by which these factors may independently and collectively influence the development of obesity. The central hypothesis of this study is that the composition of gut microbiota drives SCFA production which in turn influences obesity risk at the population-level.

NCT ID: NCT03378622 Active, not recruiting - Clinical trials for Pelvic Organ Prolapse

Anchor for Robotic Sacrocolpopexy

ARiSe
Start date: November 29, 2017
Phase: Phase 3
Study type: Interventional

1. PRIMARY OBJECTIVE: To assess the effect of absorbable anchor compared to suturing for mesh attachment to vagina in robotic assisted sacrocolpopexy on the length of surgery for this portion of the procedure. 2. SECONDARY OBJECTIVES: i. To assess intraoperative and ii. postoperative complication rates, iii. Intraoperative 10 cm visual analog scale (VAS), to subjectively assess surgeon satisfaction with the technique iv. post-operative Pelvic Organ Prolapse Quantification (POPQ) evaluation for anatomic failure and v. a VAS of the vaginal walls overall appearance

NCT ID: NCT03378219 Active, not recruiting - Clinical trials for Rheumatoid Arthritis -Exposure During Pregnancy

An Observational Study on Sarilumab-exposed Pregnancies

Start date: May 18, 2018
Phase:
Study type: Observational

Primary Objective: To evaluate the relative risk of major structural birth defects, specifically a pattern of anomalies, in sarilumab-exposed pregnancies compared to disease-matched unexposed pregnancies. Secondary Objective: To evaluate the risk for sarilumab-exposure relative to the group of healthy pregnant women, and the effect of exposure on other adverse pregnancy and infants outcomes.

NCT ID: NCT03377569 Active, not recruiting - Parkinson Disease Clinical Trials

Subcortical Oscillations in Human Sleep Dysregulation

Start date: February 27, 2018
Phase:
Study type: Observational

Sleep problems are common in the United States (US) adult population (>50 million), and have a negative impact on quality of life, productivity, and healthcare. A major obstacle to understanding how the brain is involved in human sleep disorders has been the lack of recordings of human brain function, from inside the brain, during the known sleep states.

NCT ID: NCT03377543 Active, not recruiting - Inflammation Clinical Trials

Sleep and Inflammatory Resolution Pathway

Start date: June 6, 2018
Phase: Early Phase 1
Study type: Interventional

Goal of this project is to investigate whether increases in inflammation that result from common patterns of restricting sleep on week nights and catching up on sleep over the weekend are caused by disruption in the newly discovered inflammatory resolution pathways. These pathways are crucial in the active termination of the inflammatory response, and their disruption may contribute to ongoing unresolved inflammation, which has been observed not only during periods of sleep restriction, but also after recovery sleep has been obtained. If the hypothesis is true, it is possible that increasing the body's natural production of endogenous, inflammatory resolution mediators may provide a non-behavioral strategy to limit the inflammatory consequences in those undergoing periods of sleep restriction with intermittent recovery sleep.

NCT ID: NCT03377491 Active, not recruiting - Clinical trials for Pancreas Adenocarcinoma

Effect of Tumor Treating Fields (TTFields, 150 kHz) as Front-Line Treatment of Locally-advanced Pancreatic Adenocarcinoma Concomitant With Gemcitabine and Nab-paclitaxel (PANOVA-3)

Start date: February 10, 2018
Phase: Phase 3
Study type: Interventional

Brief Summary: The study is a prospective, randomized controlled phase III trial aimed to test the efficacy and safety of Tumor Treating Fields (TTFields) in combination with gemcitabine and nab-paclitaxel, for front line treatment of locally-advanced pancreatic adenocarcinoma.The device is an experimental, portable, battery operated device for chronic administration of alternating electric fields (termed TTFields or TTF) to the region of the malignant tumor, by means of surface, insulated electrode arrays.

NCT ID: NCT03377387 Active, not recruiting - Breast Cancer Clinical Trials

Capecitabine 7/7 Schedule With Neratinib in Patients With Metastatic HER2-Positive Breast Cancer

Start date: December 13, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

This is a phase l/II study. The purpose of this study is to test the safety of the study drug neratinib in combination with a standard chemotherapy drug called capecitabine at different doses to find out what effects, if any, it has on people. Capecitabine (Xeloda®) is approved by the Food and Drug Administration (FDA) for advanced breast cancer treatment. Neratinib is an investigational drug, meaning the FDA has not approved the use of this drug for advanced breast cancer. The combination of capecitabine and neratinib has been studied before in another study where capecitabine was administered using the standard dosing schedule. In this study, the investigators want to find out if a different dosing schedule of capecitabine combined with neratinib is safer. This different dosing schedule is experimental, meaning the administration schedule of capecitabine and neratinib is not FDA approved for treatment for HER2 positive advanced breast cancer.

NCT ID: NCT03377361 Active, not recruiting - Colorectal Cancer Clinical Trials

An Investigational Immuno-therapy Study Of Nivolumab In Combination With Trametinib With Or Without Ipilimumab In Participants With Previously Treated Cancer of the Colon or Rectum That Has Spread

CheckMate 9N9
Start date: February 1, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to investigate treatment with nivolumab in combination with trametinib with or without ipilimumab in participants with previously treated cancer of the colon or rectum that has spread.

NCT ID: NCT03377023 Active, not recruiting - Clinical trials for Non Small Cell Lung Cancer

Phase I/II Study of Nivolumab and Ipilimumab Combined With Nintedanib in Non Small Cell Lung Cancer

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

The main purpose of this study is to see if the combination of nivolumab, ipilimumab and nintedanib is effective in people with non- small cell lung cancer. Researchers also want to find out if the combination of nivolumab, ipilimumab and nintedanib is safe and tolerable.