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NCT ID: NCT03811821 Active, not recruiting - Fecal Incontinence Clinical Trials

Fecal Incontinence Treatment (FIT) Study

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

Patients with severe fecal incontinence (FI), defined as two or more episodes of staining, solid or liquid FI per week, and who meet the inclusion criteria for Injection of Solesta (INJ; an inert bulking agent), or Biofeedback (BIO) will be enrolled. The baseline rate of FI will be assessed using a 2-week daily stool diary. All participants will initially be enrolled into a 4-week trial of Enhanced Medical Management (EMM; education, pelvic floor exercises, and use of non-prescription drugs to normalize stool consistency). Those who demonstrate at least a 75% reduction in FI frequency will not be randomized to one of the two treatment groups but will be followed-up for two years. Those not showing a 75% reduction in FI frequency will be randomized to BIO or INJ and will be evaluated three months later with respect to efficacy for reducing the frequency of fecal incontinence, safety of the interventions, and cost of providing care. All participants who experience a 75% decrease in FI after three months of treatment, compared to baseline, will be followed-up for a further 21 months, for a total of 24 months from the time of treatment initiation. To assess the long-term response to treatment, those who improve less than 75% in FI episodes will be offered an additional treatment with either the treatment to which they were not randomized or sacral nerve stimulation (SNS). Anorectal manometry and Magnetic Evoked Potentials will be used to subtype the physiological basis for FI. Quality of life and psychological factors will be used to assess outcomes.

NCT ID: NCT03811561 Active, not recruiting - Clinical trials for Diabetes Mellitus, Type 2

A Research Study to Look at How Semaglutide Compared to Placebo Affects Diabetic Eye Disease in People With Type 2 Diabetes

FOCUS
Start date: May 8, 2019
Phase: Phase 3
Study type: Interventional

This study will look at the long-term effects of semaglutide (active medicine) on diabetic eye disease when compared to placebo (dummy medicine). The study will be performed in people with type 2 diabetes. Participants will either get semaglutide or placebo in addition to their diabetes medicines - which treatment the participant gets is decided by chance. Participants will inject the study medicine using a pen-injector. The medicine must be injected in a skin fold in the stomach, thigh or upper arm once a week. The study will last for 5 years.

NCT ID: NCT03811535 Active, not recruiting - Clinical trials for Growth Hormone Deficiency in Children

A Research Study in Children With a Low Level of Hormone to Grow. Treatment is Somapacitan Once a Week Compared to Norditropin® Once a Day (REAL4)

REAL4
Start date: May 20, 2019
Phase: Phase 3
Study type: Interventional

The study compares 2 medicines for children who do not have enough hormone to grow: somapacitan given once a week (a new medicine) and Norditropin® given once a day (the medicine doctors can already prescribe). Researchers will test to see how well somapacitan works. The study will also test if somapacitan is safe. Participants will either get somapacitan or Norditropin® - which treatment participants get, is decided by chance. Both participants and the study doctor will know which treatment participants get. The study will last for 4 years. Participants will attend 19 clinic visits and have 1 phone call with the study doctor.

NCT ID: NCT03811522 Active, not recruiting - Clinical trials for Carbon Dioxide Insufflation

Comparison Air Versus Carbon Dioxide Insufflation in Single Balloon Anterograde Enteroscopy

Start date: January 1, 2019
Phase:
Study type: Observational

Observation study comparing patient symptoms of bloating, pain, and nausea between CO2 insufflation vs. O2 insufflation in anterograde balloon enteroscopy.

NCT ID: NCT03811171 Active, not recruiting - Renal Calculi Clinical Trials

Break Wave(TM) Extracorporeal Lithotripter First-in-Human Study

Start date: August 20, 2019
Phase: N/A
Study type: Interventional

This is a prospective, open-label, multi-center, single-arm (non-randomized) study to assess the safety and effectiveness of breaking stones in the upper urinary tract using the SonoMotion Break Wave technology. Up to 30 subjects will be included. The procedure will be performed in a hospital surgical environment as an outpatient (without being admitted) or in a non-surgical environment such as a clinic or office procedure room. The procedure will be performed under varying levels of anesthesia ranging from no anesthesia to general anesthesia (fully asleep). Stones will be limited to ≤ 10 mm for lower pole stones and ≤ 20 mm everywhere else. Safety will be measured by the self-reported occurrences of adverse events, unplanned emergency department or clinic visits, and the need for further intervention. Fragmentation will be measured by self-reported stone passage and a comparison of computed tomography (CT) images before and after the procedure.

NCT ID: NCT03811002 Active, not recruiting - Clinical trials for Stage III Lung Cancer AJCC v8

Testing the Addition of a New Immunotherapy Drug, Atezolizumab (MPDL3280A), to the Usual Chemoradiation (CRT) Therapy Treatment for Limited Stage Small Cell Lung Cancer (LS-SCLC)

Start date: July 26, 2019
Phase: Phase 3
Study type: Interventional

This phase II/III trial studies how well chemotherapy and radiation therapy (chemoradiation) with or without atezolizumab works in treating patients with limited stage small cell lung cancer. Drugs used in chemotherapy, such as etoposide, cisplatin, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving chemoradiation with or without atezolizumab may work better in treating patients with limited stage small cell lung cancer.

NCT ID: NCT03810911 Active, not recruiting - Anemia Clinical Trials

Mechanisms of EPO-induced Hypertension

EPIC
Start date: January 4, 2021
Phase: Phase 2
Study type: Interventional

The investigators hypothesize that compared to untreated controls, erythropoietin (EPO) therapy in anemic patients with chronic kidney disease will raise diastolic blood pressure (BP). The magnitude of increase in diastolic BP at 12 weeks after treatment will be related to two factors. First, endothelial dysfunction and worsening of endothelial function from baseline to 4 weeks and second, the change of forearm blood flow in response to breathing oxygen and the change in this measure from baseline to 4 weeks. Study procedures include fasting blood draws, ambulatory blood pressure, urine collection, and forearm blood flow tests. The study hopes to accrue 160 subjects.

NCT ID: NCT03810807 Active, not recruiting - Clinical trials for Metastatic Non-small Cell Lung Cancer

Study of Dacomitinib and Osimertinib for Patients With Advanced EGFR Mutant Lung Cancer

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

The purpose of this study is to test the safety of dacomitinib and osimertinib, at increasing doses, to find out what effects, if any, this combination of drugs has on people with metastatic EGFR mutant lung cancer that has not been treated with an EGFR TKI.

NCT ID: NCT03809533 Active, not recruiting - Hepatitis C Clinical Trials

The Use of Hepatitis C Positive Kidneys in Hepatitis C Negative Kidney Transplant Recipients

Start date: May 29, 2019
Phase: Phase 2
Study type: Interventional

This is an open-label, pilot trial to test the safety and efficacy of transplantation of kidneys from hepatitis C seropositive non-viremic (HCV Ab+/NAT-) and HCV seropositive viremic (HCV Ab+/NAT+) donors to HCV seronegative recipients on the kidney transplant waitlist. Treatment and prophylaxis will be administered using a transmission-triggered approach for the first scenario (HCV Ab+/NAT- donors, arm 1) and a prophylaxis approach for the later scenario (HCV Ab+/NAT+ donors, arm 2).

NCT ID: NCT03809000 Active, not recruiting - Prostate Cancer Clinical Trials

A Study of Salvage Radiotherapy With or Without Enzalutamide in Recurrent Prostate Cancer Following Surgery

STEEL
Start date: April 15, 2019
Phase: Phase 2
Study type: Interventional

Patients with post-prostatectomy PSA (Prostate Specific Antigen) recurrences with aggressive disease features will receive salvage radiation therapy and standard androgen deprivation therapy (ADT) or enhanced ADT to determine if there is any improvement in progression-free survival when enhanced ADT is used compared to standard ADT.