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NCT ID: NCT03758209 Completed - Colorectal Cancer Clinical Trials

Prehabilitation Versus Enhanced Recovery Program for Elective Colorectal Cancer Surgery.

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

Elective surgery is the most effective treatment option for colorectal cancer, however it has been recognized to be associated with high morbidity and mortality risks. ERAS (Enhanced Recovery After Surgery) is a preoperative multimodality treatment package, which has been well investigated and proved to be effective in reducing early postoperative morbidity, mortality, length of hospital stay and hospital costs, as well. Still, a good proportion of patients are not suitable for ERAS program, mainly based on lack of compliance and the impaired physical function before surgery. Prehabilitation Program is a recently introduced trimodal preoperative preparation (training) program, which addresses improvement of physical, mental and nutritional status of the high risk elective surgery patients. This study aims to investigate the benefit of all efforts of a 4-6-week preoperative preparation program (Prehabilitation) being added to an established ERAS protocol.

NCT ID: NCT03756974 Completed - Clinical trials for Spasticity Due to Multiple Sclerosis

BX-1 in Spasticity Due to Multiple Sclerosis

Start date: February 18, 2019
Phase: Phase 3
Study type: Interventional

To investigate the efficacy and safety of orally administered BX-1 compared to placebo in patients with spasticity due to multiple sclerosis not sufficiently controlled by current anti-spasticity medication

NCT ID: NCT03755934 Completed - Clinical trials for Painful Diabetic Neuropathy

Efficacy and Safety of MEDI7352 in Subjects With Painful Diabetic Neuropathy

Start date: November 19, 2018
Phase: Phase 2
Study type: Interventional

This is a study investigating the effect of MEDI7352 on chronic pain in patients with painful diabetic neuropathy. The study incudes a screening period of up to 45 days and a 12-week treatment period during which MEDI7352 or placebo will be administered intravenously (IV) on 6 occasions, with each dose separated by 14 days. There will be a 6-week follow-up period. Subjects will randomly be assigned to double-blind treatment with one of 4 dose levels of MEDI7352 or placebo

NCT ID: NCT03752970 Completed - Crohn Disease Clinical Trials

A Study Testing How BI 655130 Works in Patients With Fistulizing Crohn's Disease

Start date: February 5, 2019
Phase: Phase 2
Study type: Interventional

This is a study in adults with Crohn's Disease who also have fistulas near the anus. The study has 2 parts. The first part is to find out more about what causes the fistulas. In this part of the study, tissue samples are taken from patients. The second part of the study tests whether a medicine called spesolimab (BI 655130) helps patients with Crohn's Disease. Participants get study medication for 24 weeks. The participants are put into 2 groups. It is decided by chance who gets into which group. One group gets an intravenous drip that contains spesolimab every 4 weeks. The other group gets a placebo drip every 4 weeks. The placebo drip looks like the spesolimab drip, but contains no medicine. The doctors regularly examine fistulas of the participants. The results of the fistula examinations are compared between the groups. The doctors also check the general health of the patients.

NCT ID: NCT03751124 Completed - Uterine Fibroids Clinical Trials

Study of Relugolix With Estradiol and Norethindrone Acetate in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids

Start date: October 16, 2018
Phase: Phase 3
Study type: Interventional

The objectives of this randomized withdrawal study are to evaluate the long-term efficacy and safety of the combination of relugolix, estradiol (E2) and norethindrone acetate (NETA), once daily, for up to 104 weeks in patients with uterine fibroids who have completed a total of 52 weeks of treatment, including a 24-week treatment period in a parent study (study MVT-601-3001 or MVT-601-3002) and a 28-week treatment period in the open-label extension study (MVT-601-3003), and who meet the definition of responder, defined as a patient who demonstrates a menstrual blood loss of < 80 mL and at least a 50% reduction from parent study baseline menstrual blood loss volume on the alkaline hematin analysis of the feminine products returned at Week 48 in the extension study.

NCT ID: NCT03750552 Completed - Clinical trials for Symptomatic Neurogenic Orthostatic Hypotension

Clinical Effect of Ampreloxetine (TD-9855) for Treating Symptomatic nOH in Subjects With Primary Autonomic Failure

SEQUOIA
Start date: January 24, 2019
Phase: Phase 3
Study type: Interventional

A Phase 3 study to evaluate efficacy, safety, and tolerability of ampreloxetine (TD-9855) in subjects with primary autonomic failures (MSA, PD, or PAF) and symptomatic nOH with up to 4 weeks of treatment.

NCT ID: NCT03749252 Completed - Pediatric Patients Clinical Trials

Pharmacokinetics, Safety and Efficacy of P03277 in Pediatric Patients Undergoing Central Nervous System Contrast-enhanced MRI

Start date: November 6, 2018
Phase: Phase 2
Study type: Interventional

This is a pharmacokinetics (PK), open-label, uncontrolled, multicenter phase II trial with age-staggered approach. The primary objective is to evaluate the PK profile of gadopiclenol in plasma following single IV injection of 0.05 mmol/kg body weight (BW) in pediatric population aged from 2 to 17 years undergoing CNS contrast-enhanced MRI (CNS cohort).

NCT ID: NCT03748134 Completed - Clinical trials for Esophageal Squamous Cell Carcinoma

Sintilimab or Placebo With Chemotherapy in Esophageal Squamous Cell Carcinoma ( ORIENT-15 )

Start date: December 24, 2018
Phase: Phase 3
Study type: Interventional

This is a randomized, double-blind multi-center, phase III study comparing the efficacy and safety of sintilimab or placebo in combination with chemotherapy as first-line treatment in subjects with unresectable, locally advanced recurrent or metastatic esophageal squamous cell carcinoma. After the interim analysis conducted by the iDMC, an open-label assignment of experimental arm therapy will continue in regions outside of China, in order to further evaluate the efficacy and safety of sintilimab in combination with chemotherapy in subjects representing the western population with advanced esophageal squamous cell carcinoma

NCT ID: NCT03745638 Completed - Atopic Dermatitis Clinical Trials

Topical Ruxolitinib Evaluation in Atopic Dermatitis Study 1 (TRuE AD1) - An Efficacy and Safety Study of Ruxolitinib Cream in Adolescents and Adults With Atopic Dermatitis

Start date: December 20, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the efficacy and safety of twice daily ruxolitinib cream in adolescents and adults with Atopic Dermatitis (AD).

NCT ID: NCT03744507 Completed - Endometriosis Clinical Trials

Bone Mineral Density in Women With Uterine Fibroids or Endometriosis

Start date: August 3, 2018
Phase:
Study type: Observational

The purpose of this study is to characterize the longitudinal bone mineral density (BMD) in premenopausal women with uterine fibroids or endometriosis.