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NCT ID: NCT03447132 Completed - Clinical trials for Breast Neoplasm Female

Fulvestrant Versus Fulvestrant Plus Palbociclib in Operable Breast Cancer Responding to Fulvestrant

SAFIA
Start date: December 20, 2017
Phase: Phase 3
Study type: Interventional

This is a multicenter, international, double-blind randomized Phase III study to evaluate the pathological complete response (pCR) according to Chevalier classification between Fulvestrant® and the combination of Fulvestrant® plus Palbociclib as neoadjuvant therapy of hormone-sensitive patients with operable luminal breast cancer. Eligible patients will be assessed upfront using the OncotypeDX® molecular test (Recurrence Score <31).

NCT ID: NCT03431701 Completed - Vaginal Scrubbing Clinical Trials

Chlorhexidine Vaginal Cleansing Versus Iodine Prior to C-section and the Rate of Postoperative Infection

Start date: February 8, 2018
Phase: N/A
Study type: Interventional

Background: Women undergoing cesarean delivery have 5 to 20 fold greater risk for infection and infectious morbidity compared with those undergoing vaginal birth. Endometritis, febrile morbidity, and wound infection are the most frequent complications of post cesarean infections. Endometritis accounts for 6-27% followed by clinically significant fever, which was reported about 5-24%,while the incidence of wound infection is about 2-9%.Previous studies evaluated whether vaginal cleansing can reduce the incidence of postoperative infectious morbidity. In most of the studies, povidone iodine was used as intervention. Objectives: The aim of this study is to test the hypothesis that preoperative vaginal cleansing with chlorhexidine would be superior to iodine for the prevention of maternal infectious morbidities including endometritis, fever and wound complications. Methods: This prospective randomized single blinded controlled trial will be conducted at Makassed General Hospital between February 2018 and January 2019. Total of 300 patients, 150 in each group, will be enrolled. Group 1 patients will receive chlorhexidine vaginal cleansing while group 2 patients will receive iodine prior to C-section. Adverse post infectious morbidities such as endometritis, febrile illness and wound infections will be observed within 30 days of C-section.

NCT ID: NCT03427086 Completed - Clinical trials for Amyotrophic Lateral Sclerosis

Safety and Tolerability of High Dose Biotin in Patients With Amyotrophic Lateral Sclerosis

Start date: January 29, 2018
Phase: Phase 2
Study type: Interventional

This is a randomized double blinded randomized 2:1 study. The duration of the study is 6 month. The safety and tolerability of high doses of biotin (300 mg/ day) will be compared to placebo in patients with amyotrophic lateral sclerosis. Patients will be evaluated at baseline, 3, and 6 month. The primary outcome will be any adverse effects recorded. The secondary outcomes will be motor disability measured by ALS-FRS, change in Pulmonary function test parameters (FEV1- FVC), change in subject weight (in kg).

NCT ID: NCT03417193 Completed - Postoperative Pain Clinical Trials

Opioid Free Anesthesia and Major Spine Surgery

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

This study compares the intraoperative opioid free anesthesia approach in multilevel spine posterior instrumentation surgery to a conventional opioid-based anesthesia. Half of participants will receive opioid free anesthesia with dexmedetomidine, lidocaine and ketamine while the other half will receive opioid based anesthesia with fentanyl, remi-fentanyl and ketamine

NCT ID: NCT03395639 Completed - Cardiac Disease Clinical Trials

Edoxaban for Prevention of Blood Vessels Being Blocked by Clots (Thrombotic Events) in Children at Risk Because of Cardiac Disease

Start date: May 15, 2018
Phase: Phase 3
Study type: Interventional

A committee will judge the safety and effectiveness of edoxaban and the regular treatment (standard of care). All children in the study will receive free treatment. They will have a 2 in 3 chance to receive edoxaban, and a 1 in 3 chance to receive the standard of care for preventing blood clots. The study will find out if edoxaban is safer and more effective than the standard of care.

NCT ID: NCT03395184 Completed - Crohn's Disease Clinical Trials

Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF-06700841 In Subjects With Moderate To Severe Crohn's Disease

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

The objectives of this study are to evaluate the efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics of PF-06651600 (200 mg for 8 weeks followed by 50 mg for 4 weeks) dosed once daily and PF-06700841 (60 mg for 12 weeks) dosed once daily during an induction period of 12 weeks, followed by an open label extension period at doses of 50 mg and 30 mg of PF 06651600 and PF 06700841, respectively, for 52 weeks.

NCT ID: NCT03372083 Completed - Iron Overload Clinical Trials

Safety Study of Crushed Deferasirox Film Coated Tablets in Pediatric Patients With Transfusional Hemosiderosis

MIMAS
Start date: January 16, 2018
Phase: Phase 4
Study type: Interventional

This study employed a prospective, single-arm, global multi-center interventional open-label, non-randomized design to identify and assess safety profile of the crushed deferasirox FCT when administered up to 24 weeks in pediatric patients aged ≥2 to <6 years with transfusional hemosiderosis. The study was designed to enroll a minimum of 40 patients. Forty-four patients were treated and analyzed.

NCT ID: NCT03342404 Completed - Thalassemia Clinical Trials

A Study to Determine the Efficacy and Safety of Luspatercept in Adults With Non Transfusion Dependent Beta (β)-Thalassemia

BEYOND
Start date: February 5, 2018
Phase: Phase 2
Study type: Interventional

This is a Phase 2, double-blind, randomized, placebo-controlled, multicenter study to determine the efficacy and safety of luspatercept (ACE-536) versus placebo in adults with non-transfusion dependent beta (β)-thalassemia. The study is divided into the Screening Period, Double-blind Treatment Period (DBTP), Open-label Phase (OLP), and Post-Treatment Follow-up Period (PTFP). It is planned to randomize approximately 150 subjects at a 2:1 ratio of luspatercept versus placebo.

NCT ID: NCT03337529 Completed - Clinical trials for Restless Leg Syndrome

Restless Legs Syndrome in Hemodialysis Patients

Start date: September 15, 2017
Phase: N/A
Study type: Interventional

Restless legs syndrome (RLS) is defined as the spontaneous movement of the limbs (mainly legs) associated with unpleasant - painful sensation which is relieved by moving the affected limb. It is a common disorder in hemodialysis patients that leads to insomnia, impaired daytime functioning and quality of life. Symptoms of RLS are estimated to affect up to 25% of patients on dialysis when the international RLS diagnostic criteria are applied. Various pharmacological and non-pharmacological interventions have been used to treat primary RLS. However, the evidence for use of these interventions in people with End stage renal disease is not well established; and some have serious side effects. Because high oxidative stress has been implicated in the pathogenesis of RLS, investigators thought of evaluating the efficacy of vitamin C in reducing the severity of RLS symptoms in hemodialysis patients in this randomized, double-blind, placebo-controlled, two arm parallel trial. To note that only two studies were done worldwide that proved the efficacy of vitamin C in those patients.

NCT ID: NCT03335462 Completed - Lumbar Plexus Block Clinical Trials

Spread of Paravertebral Injections in the Lumbar Plexus Area

Start date: November 2, 2017
Phase: N/A
Study type: Interventional

Lumbar paravertebral block (LPB) has been used for anesthesia in different settings such as in varicocelectomy and inguinal hernia repair in adults and pediatrics. Different studies considered LPB as an alternative to general and spinal anesthesia when contraindications exist, especially in elderly patients. However, the results obtained when using LPB are controversial in terms of number of injections performed and the success rates.