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NCT ID: NCT03604445 Terminated - Neoplasms Clinical Trials

This Study Aims to Find and Test a Safe Dose of BI 905677 in Patients With Different Types of Cancer (Solid Tumours)

Start date: August 8, 2018
Phase: Phase 1
Study type: Interventional

This study is open to adults with different types of advanced cancer (solid tumours). This study is open to people in whom previous treatments were not successful. The purpose of this study is to find out the highest dose of BI 905677 the participants can tolerate. BI 905677 is a type of an antibody that is being developed to treat cancer. One dose of BI 905677 is given to the participants every 2 or 3 weeks as infusion into a vein. In this study, BI 905677 is given to humans for the first time. The participants visit the study site at least once a week so that the doctors can check their general health. The participants are in the study for as long as they benefit from and can tolerate treatment.

NCT ID: NCT03604289 Terminated - Obesity Clinical Trials

Angiotensin 1-7 in Obesity Hypertension

Start date: April 1, 2019
Phase: Early Phase 1
Study type: Interventional

The purpose of this study is to find out if the investigational drug angiotensin-(1-7) improves cardiovascular health in patients with obesity and high blood pressure.

NCT ID: NCT03603964 Terminated - Clinical trials for Acute Myeloid Leukemia

Guadecitabine Extension Study

Start date: July 18, 2018
Phase: Phase 2
Study type: Interventional

This is a multicenter, open-label extension study for participants who participated in a previous Astex-sponsored guadecitabine clinical study [including but not limited to SGI-110-01 (NCT01261312), SGI-110-04 (NCT02348489), SGI-110-06 (NCT02920008), and SGI-110-07 (NCT02907359)].

NCT ID: NCT03603652 Terminated - Lung Cancer Clinical Trials

NEUWAVE Flex Microwave Ablation System in the Ablation of Primary Soft Tissue Lesions of the Lung

Start date: June 29, 2018
Phase: N/A
Study type: Interventional

Patients with medically inoperable primary soft tissue lesion of the lung will have transbronchial microwave ablation performed via transbronchial approach by an interventional pulmonologist or thoracic surgeon using CT imaging. Prior to the ablation procedure, the treating physician will use endobronchial ultrasound to confirm staging. Patients will be followed for one year following the ablation procedure for efficacy and safety.

NCT ID: NCT03603639 Terminated - Clinical trials for Photosensitive Epilepsy

A Study to Evaluate the Pharmacodynamic Activity of E2730 in Adult Participants With Photosensitive Epilepsy

Start date: July 27, 2018
Phase: Phase 2
Study type: Interventional

The primary purpose of the study is to assess the pharmacodynamic (PD) activity of E2730 as measured by suppression of epileptic photoparoxysmal response (PPR) in the participant's most sensitive eye condition in participants with photosensitive epilepsy.

NCT ID: NCT03603288 Terminated - Clinical trials for Duchenne Muscular Dystrophy

Phase III Study With Idebenone in Patients With Duchenne Muscular Dystrophy (SIDEROS-E)

SIDEROS-E
Start date: July 4, 2018
Phase: Phase 3
Study type: Interventional

The purpose of the study is to assess the long-term safety and efficacy of idebenone in patients with Duchenne muscular dystrophy (DMD) who completed the SIDEROS study.

NCT ID: NCT03603275 Terminated - Hemophilia A Clinical Trials

Assessing Physician and Hemophilia A Patient Reasons and Expectations for Switching Treatment to Kovaltry & Jivi: A Nested Study Within an Existing Registry

Start date: August 6, 2018
Phase:
Study type: Observational

This US study aims to assess hemophilia A patient characteristics and reasons for switching from both patient/caregiver and physician perspectives. For this purpose, this research study will include hemophilia A patients who have switched from an existing therapy to Kovaltry or Jivi. In doing so, real world evidence will be obtained from both patient and physician perspectives offering key insights for effective therapeutic management of patients with hemophilia A and to more fully understand what drives patient switching from a patient perspective and a physician perspective.

NCT ID: NCT03603080 Terminated - Obesity Clinical Trials

Efficacy of Pharmacotherapy to Enhance Weight Loss Following Sleeve Gastrectomy

Start date: March 1, 2019
Phase: Phase 4
Study type: Interventional

The study will investigate the effects of Metformin and Topiramate prescribed at 4 weeks post-surgery on overall weight loss at 6 months post-surgery. The investigators will study patients who, based on current diagnoses and medication regimens, could be expected to benefit the most by taking a medication to facilitate additional post-surgery weight loss. Patients scheduled to undergo laparoscopic sleeve gastrectomy (LSG) at Hartford Hospital's Bariatric and Metabolic Surgery Program will be screened, consented and enrolled in the study. Prior to surgery patients will be randomized to either pharmacotherapy or no pharmacotherapy following LSG. For those randomized to receive pharmacotherapy, medications will be initiated at 4 weeks, as this is the estimated time post-LSG at which patients advance from a liquid diet to soft foods allowing medications to be better tolerated. Once randomly assigned to the medication group, patients will receive Metformin or Topiramate based upon physician judgment and medical history. Dosages will not be adjusted during the course of the study. The primary outcome will be % total body weight loss (%TWL) at 6 months following surgery, as the majority of the weight loss after LSG occurs during the first 6 months. Data collected through up to 12 months will be analyzed. The %TWL for both arms of the study will also be assessed at 8 weeks, 16 weeks, and 9 months and one-year post-LSG. Resolution of comorbidities will be noted.

NCT ID: NCT03602976 Terminated - Clinical trials for Hepatic Sarcoidosis, Elevated Alkaline Phosphatase

Ursodeoxycholic Acid (UDCA) for Hepatic Sarcoidosis

Start date: August 20, 2018
Phase: Phase 2
Study type: Interventional

This study aims to (1) evaluate efficacy of UDCA in improving liver function and quality of life; (2) monitor safety, tolerability of UDCA, as well as progression of hepatic sarcoidosis and liver disease, in patients diagnosed with hepatic sarcoidosis. A minimum of 10 subjects will be followed for 12 months. For all subjects, initial 6 months will be observational; in subsequent 6 months, UDCA will be administered. Visits will occur every 3 months and involve routine blood collection.

NCT ID: NCT03602456 Terminated - Health Insurance Clinical Trials

Evaluation of the Health and Economic Consequences of Kentucky's Section 1115 Demonstration Waiver

Start date: April 1, 2018
Phase:
Study type: Observational

Kentucky HEALTH was an 1115 Medicaid waiver that was approved by the Centers for Medicare and Medicaid Services (CMS) in January 2018. In what was initially planned to be a 5-year demonstration, KY HEALTH aimed to modify the traditional Medicaid program to improve health behaviors, health outcomes, and socioeconomic outcomes in the waiver-eligible population through several innovations. In brief, these included introducing Community Engagement requirements (i.e. work requirements), monthly premiums, MyRewards accounts for dental and vision services, and annual recertification. If beneficiaries failed to complete these requirements, some penalties included suspension and 6-month lockouts from the Medicaid program. The Commonwealth of Kentucky had chosen to implement this program in a randomized fashion, where 10% of the target population was randomly assigned to continue receiving traditional Medicaid while 90% would receive Kentucky HEALTH benefits and be subject to the requirements discussed above. Randomization was conducted by the state, through their separate contract with a non-profit research firm (National Opinion Research Center, NORC). The NORC also engaged in primary data collection to support the analysis of the project. The University of Pennsylvania team served as the non-partisan, independent evaluators of this randomized intervention conducted by the Commonwealth of Kentucky. The analysis would measure the impact of KY HEALTH compared to traditional Medicaid. Due to ongoing legal challenges and a change in administrations, the implementation of Kentucky HEALTH was delayed and eventually cancelled. On March 27, 2019, the DC District Court Judge concluded that the approvals did not address how the requests would align with Medicaid's core objectives. At that point, data collection was ongoing although Kentucky HEALTH was delayed until further notice. Kentucky's 2019 gubernatorial election took place on November 5th and resulted in the election of a new governor. On December 16, 2019, a termination request was sent to CMS as a notification of the new administration's intention to cancel Kentucky HEALTH. On December 18, 2019, a clarification letter was sent to CMS to notify them that the termination did not apply to the SUD program and NEMT portion (among others) of the waiver. While the Penn team will continue conducting a separate evaluation of the ongoing SUD program, the randomized controlled trial and data collection described in this study will end with the terminated components of the waiver. As a result of the legal challenges, the implementation of Kentucky HEALTH was delayed before being cancelled altogether. The study start and end dates above reflect the beginning of data collection and the termination letter that was sent to CMS, respectively. A total of 9,396 surveys (KHES), 127 beneficiary semi-structured interviews, and 40 provider interviews were conducted.