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NCT ID: NCT03489265 Withdrawn - Diarrhea Clinical Trials

Effects of Eluxadoline (Viberzi®) 100 mg Twice Daily on Diarrhea-Associated Fecal Incontinence

ELXDFI
Start date: April 2019
Phase: Phase 2
Study type: Interventional

Accidental bowel leakage (fecal incontinence) increases in people who have diarrhea and sensations of urgency to have a bowel movement. Drugs such as loperamide (Imodium) that reduce diarrhea improve accidental bowel leakage, but loperamide has disadvantages: it is difficult to find a dose that does not cause constipation, and it does not reduce urge sensations. Eluxadoline is a new drug that is effective for reducing diarrhea, abdominal pain, and urgency in patients with irritable bowel syndrome, and it may be less likely than loperamide to cause severe constipation. Therefore, eluxadoline may help patients manage accidental bowel leakage caused by diarrhea. The chemical name for Viberzi® is eluxadoline. The primary aims of this study are to find out if eluxadoline at a dose of 100 mg orally twice a day will reduce the average number of days the patient has accidental bowel leakage, and to see if the rate of accidental bowel leakage increases when the patient stops taking eluxadoline. Additional goals are to find out if eluxadoline decreases diarrhea and urge sensations. This is a small (pilot) study to show whether eluxadoline is an effective way of treating accidental bowel leakage. If the study shows this, a larger study will be needed. There are three phases to this 12-week study: (1) A two-week run-in period to see if the patient meets the inclusion criteria. (2) Two months for treatment including one month on eluxadoline and one on placebo (sugar pills) twice a day. (3) A two-week follow-up to see what happens when you stop taking eluxadoline. To participate in the study, patients should be aged 18 or older. Patients with inflammatory bowel disease, anal fissures, or congenital malformations will be excluded. The primary outcome is the average number of days per week with any solid or liquid bowel accidents. Additional information includes: (1) Number of days per week the patient takes loperamide, (2) days per week with loose or watery stools, (3) days per week with moderate to strong urge sensations, and (4) questionnaires to measure the severity of accidental bowel leakage, quality of life, anxiety, and depression. There will be up to 38 patients in the study.

NCT ID: NCT03569150 Withdrawn - Clinical trials for Advance Care Planning

Culturally-Adapting a Communication Intervention to Improve Palliative Care Literacy on Two Native American Reservations

Start date: April 2019
Phase: N/A
Study type: Interventional

This study will evaluate the feasibility, acceptability, and perceived effectiveness of the culturally-adapted COMFORT Communication Curriculum in two Native American reservation communities. Participants in one community will have an advance care planning conversation with a healthcare professional trained in the the culturally-adapted curriculum. Participants in the other community will receive usual care.

NCT ID: NCT03688230 Withdrawn - Clinical trials for Metastatic Colorectal Cancer

Study of Abituzumab in Combination With Cetuximab and FOLFIRI in Patients With Metastatic Colorectal Cancer.

AMELION
Start date: April 2019
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of the experimental drug abituzumab (EMD525797) in combination with cetuximab and FOLFIRI in RAS wild-type, left-sided, metastatic colorectal cancer patients with high ανβ6 integrin expression.

NCT ID: NCT03724955 Withdrawn - Clinical trials for Cystic Fibrosis Related Bone Disease

Pilot E2 for Hypogonadal Women With CFBD

Start date: April 2019
Phase: Phase 4
Study type: Interventional

The study is a prospective, double blinded, placebo controlled, randomized study to evaluate the effects of daily oral estrogen supplements on bone health, sexual and reproductive health, quality of life and markers of inflammation and lung function when given to hypogonadal women with Cystic Fibrosis related Bone Disease (CFBD).

NCT ID: NCT03731806 Withdrawn - Celiac Disease Clinical Trials

Capsule Endoscopy in Newly Diagnosed Patients of Celiac Disease

Start date: April 2019
Phase:
Study type: Observational

Celiac Disease is an autoimmune disorder that affects approximately 1% of the world's population 1. The diagnosis of CD requires clinical, histopathological and serological factors 2. Since upper gastrointestinal endoscopy allows only visualization of the small bowel up to the second part of duodenum therefore this study was designed to determine involvement of different segments of small bowel using endoscopic scale by Bonatto MW et al 3 in newly diagnosed patients of celiac disease.

NCT ID: NCT02301494 Withdrawn - Mycosis Fungoides Clinical Trials

Effectiveness of Imiquimod Topical Cream in Early Stage Cutaneous T-cell Lymphoma

CTCL
Start date: April 2020
Phase: N/A
Study type: Interventional

This study is being conducted by Brian Poligone, MD PhD. The purpose of this study is to determine safety, effectiveness, and tolerability of two topical therapies, imiquimod and fluocinonide, for patients with early stage Cutaneous T-cell Lymphoma (CTCL).

NCT ID: NCT03517995 Withdrawn - Bladder Cancer Clinical Trials

Randomized, Phase II Clinical Trial of Sulforaphane in Bladder Cancer Chemoprevention

Start date: April 2020
Phase: Phase 2
Study type: Interventional

The main purpose of this study is to see if Prostaphane is effective and can help reduce the progression of bladder cancer. Researchers also want to find out if Prostaphane is safe and tolerable, and to evaluate how Prostaphane works to reduce the progression of bladder cancer. This study will compare Prostaphane with a placebo to see if taking Prostaphane is better than taking a placebo. A placebo is a pill that looks like Prostaphane but has no drug or other active ingredients in it. The study will be presented to eligible patients by the patient's surgeon at the time when an appointment is made for cystoscopy for suspicion of bladder cancer (BC) or to confirm BC diagnosis.

NCT ID: NCT03537521 Withdrawn - Urgent Surgery Clinical Trials

Reversal Agent Use in Patients Treated With Direct Oral Anticoagulants or Vitamin K Antagonists (RADOA). Focus on New Antidots

Start date: April 2020
Phase:
Study type: Observational [Patient Registry]

Patients treated with Vitamin K antagonists (VKA) or direct oral anticoagulants as Rivaroxaban, Apixaban, Edoxaban or Dabigatran, who experience severe bleeding and/or need urgent interventions/operations that cannot wait are included in this registry, or during emergency operations

NCT ID: NCT03540225 Withdrawn - Premature Birth Clinical Trials

Vaginal Progesterone for the Prevention of Preterm Birth in Twins

POPPET
Start date: April 2020
Phase: Phase 3
Study type: Interventional

This trial is a randomised, multi-centre, 2 x 2 factorial designed pilot trial with two factors of 200mg vs. 400mg progesterone self-administered daily from 11-14 weeks' gestation vs. 20-24 weeks' gestation, to compare the median gestational age (in days) at delivery between the comparison groups.

NCT ID: NCT03640338 Withdrawn - Clinical trials for Degenerative Disc Disease

The Efficacy of Continuous Cold-Therapy on Postoperative Pain and Narcotics Use Following Spinal Fusion

Start date: April 2020
Phase: N/A
Study type: Interventional

Patient outcomes and satisfaction are an ever-increasing priority in surgical specialties. Cryotherapy has been utilized following spine surgery as an adjunct therapy to reduce postoperative inflammation and improve patient outcomes. However, limited studies have investigated the effect of cryotherapy on postoperative pain and narcotics use. Fountas et al. performed a randomized controlled trial to assess the impact of postoperative cryotherapy following single-level lumbar microdiscectomy. The authors reported patients receiving cryotherapy required significantly less pain medication (0.058 mg/kg/hr versus 0.067 mg/kg/hr, p<0.001) and had shorter hospital stays (1.71 days versus 2.65 days, p<0.001) as compared to the control group. In another randomized trial of single-level lumbar discectomy patients, Murata et al. demonstrated cryotherapy to have no significant effect on VAS inpatient pain scores or postoperative blood loss.