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NCT ID: NCT03683186 Enrolling by invitation - Hypertension Clinical Trials

A Study Evaluating the Long-Term Efficacy and Safety of Ralinepag in Subjects With PAH Via an Open-Label Extension

Start date: September 23, 2019
Phase: Phase 3
Study type: Interventional

Study ROR-PH-303, ADVANCE EXTENSION, is an open-label extension (OLE) study for participants with WHO Group 1 PAH who have participated in another Phase 2 or Phase 3 study of ralinepag.

NCT ID: NCT03682068 Active, not recruiting - Clinical trials for Metastatic Urothelial Cancer

Study of Durvalumab Given With Chemotherapy, Durvalumab in Combination With Tremelimumab Given With Chemotherapy, or Chemotherapy in Patients With Unresectable Urothelial Cancer

NILE
Start date: September 27, 2018
Phase: Phase 3
Study type: Interventional

This is a randomized, open-label, controlled, multi-center, global Phase III study to determine the efficacy and safety of combining durvalumab ± tremelimumab with standard of care (SoC) chemotherapy (cisplatin + gemcitabine or carboplatin + gemcitabine doublet) followed by durvalumab monotherapy versus SoC alone as first-line chemotherapy in patients with histologically or cytologically documented, unresectable, locally advanced or metastatic transitional cell carcinoma of the urothelium (including renal pelvis, ureters, urinary bladder, and urethra).

NCT ID: NCT03681093 Completed - Nasal Polyps Clinical Trials

Study of Efficacy of Fevipiprant in Patients With Nasal Polyposis and Asthma

THUNDER
Start date: March 26, 2019
Phase: Phase 3
Study type: Interventional

A Phase 3b Proof-of-Concept study to evaluate the ability of fevipiprant 150 mg and 450 mg, compared with placebo, as add-on to nasal spray standard-of-care (SoC), in reducing endoscopic nasal polyp score in adult (≥ 18 years) patients with nasal polyposis and concomitant asthma.

NCT ID: NCT03676439 Recruiting - Clinical trials for Spastic Cerebral Palsy

Lateral Cord Magnetic Stimulation For Refractory Spastic Cerebral Palsy

Start date: November 18, 2024
Phase: Phase 2/Phase 3
Study type: Interventional

Lateral cord stimulation (LCS) was discovered by the author as the producer of an average threshold increase for abnormal muscle contraction responses, in experimental pathological conditions, as described and referred. This physiological effect is proposed to improve tone, motor function and speech, in patients with spasticity of different causes, such as cerebrovascular accident, congenital brain malformations, perinatal anoxia (image called cerebral palsy), sequels of neurosurgery, etc. Due to its non-invasiveness and possible efficacy, the use of magnetic stimulation is proposed to try to demonstrate its therapeutic utility. This is the clinical test of phase 2/3 of the method, in the future, and how its use could be extended, if the results were positive, its indications could be extended to other pathological conditions, giving a greater spectrum of spastic patients, potentially benefited

NCT ID: NCT03675737 Active, not recruiting - Stomach Neoplasms Clinical Trials

Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Participants Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (MK-3475-859/KEYNOTE-859)

Start date: November 8, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy of pembrolizumab (MK-3745) in combination with chemotherapy (Cisplatin combined with 5-Fluorouracil [FP regimen] or oxaliplatin combined with capecitabine [CAPOX regimen]) versus placebo in combination with chemotherapy (FP or CAPOX regimens) in the treatment of human epidermal growth factor receptor 2 (HER2) negative advanced gastric or GEJ adenocarcinoma in adult participants. The primary hypotheses of this study are that pembrolizumab plus chemotherapy is superior to placebo plus chemotherapy in terms of overall survival (OS).

NCT ID: NCT03675308 Active, not recruiting - Psoriatic Arthritis Clinical Trials

A Study Comparing Risankizumab to Placebo in Participants With Active Psoriatic Arthritis (PsA) Who Have a History of Inadequate Response to or Intolerance to at Least One Disease Modifying Anti-Rheumatic Drug (DMARD) Therapy

KEEPsAKE 1
Start date: March 25, 2019
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the safety and efficacy of risankizumab versus placebo in participants with moderately to severely active psoriatic arthritis (PsA).

NCT ID: NCT03674112 Completed - Clinical trials for HER2-Positive Early Breast Cancer

A Study to Evaluate Patient Preference and Satisfaction of Subcutaneous Administration of the Fixed-Dose Combination of Pertuzumab and Trastuzumab in Participants With HER2-Positive Early Breast Cancer

PHranceSCa
Start date: December 19, 2018
Phase: Phase 2
Study type: Interventional

This is a Phase II, randomized, multicentre, multinational, open-label, cross-over study in adult patients who have completed neoadjuvant chemotherapy with neoadjuvant pertuzumab and trastuzumab and have undergone surgical treatment of human epidermal growth factor receptor 2 (HER2)-positive early breast cancer. The study will consist of two adjuvant treatment periods: a treatment cross-over period and a treatment continuation period. It will evaluate participant-reported preference for a subcutaneously administered fixed-dose combination formulation (FDC SC) of pertuzumab and trastuzumab compared with intravenously (IV) administered pertuzumab and trastuzumab formulations. The study will also evaluate participant-reported satisfaction with pertuzumab and trastuzumab FDC SC and health-related quality of life outcomes; healthcare professionals' perceptions of time/resource use and convenience of pertuzumab and trastuzumab FDC SC compared with pertuzumab and trastuzumab IV formulations; as well as the safety and efficacy of each study regimen.

NCT ID: NCT03673501 Active, not recruiting - Clinical trials for Gastrointestinal Stromal Tumors

A Study of Ripretinib vs Sunitinib in Advanced GIST Patients After Treatment With Imatinib

INTRIGUE
Start date: February 8, 2019
Phase: Phase 3
Study type: Interventional

This is a 2-arm, randomized, open-label, international, multicenter study comparing the efficacy of ripretinib to sunitinib in GIST patients who progressed on or were intolerant to first-line anticancer treatment with imatinib. Approximately 426 patients will be randomized in a 1:1 ratio to ripretinib 150 mg once daily (continuous dosing for 6 week cycles) or sunitinib 50 mg once daily (6 week cycles, 4 weeks on, 2 weeks off).

NCT ID: NCT03672487 Recruiting - Chagas Disease Clinical Trials

Short-course Benznidazole Treatment to Reduce Trypanosoma Cruzi Parasitic Load in Women of Reproductive Age

BETTY
Start date: June 1, 2019
Phase: Phase 3
Study type: Interventional

The investigators are proposing to perform a double-blinded, non-inferiority randomized controlled trial comparing a short 30-day treatment with BZN 150mg/day (30d/150mg) vs. a 60-day treatment with BZN 300 mg/day (60d/300mg). The investigators will recruit not previously treated T. cruzi seropositive women with a live birth during the postpartum period in Argentina, randomize them at six months postpartum, and follow them up with the following specific aims: Specific Aim 1: To measure the effect of BZN 30d/150mg compared to 60d/300mg preconceptional treatment on parasitic load measured by the frequency of positive PCR (primary outcome) and by real-time quantitative PCR (qPCR), immediately (Specific Aim 1a) and 10 months (Specific Aim 1b) after treatment. Hypothesis 1a: The frequency of positive PCR and the parasitic load measured by qPCR immediately after BZN 30d/150mg will be non-inferior (Non Inferiority [NI] margin for PCR: 10% absolute difference) to BZN 60d/300mg. Hypothesis 1b: The frequency of positive PCR and the parasitic load measured by qPCR 10 months after BZN 30d/150mg will be non-inferior (NI margin for PCR: 9% absolute difference) to BZN 60d/300mg. Specific Aim 2: To measure the frequency of serious adverse events leading to treatment interruption of BZN 30d/150mg compared to 60d/300mg. Hypothesis 2: The frequency of serious adverse events leading to treatment interruption will be 50% lower with BZN 30d/150mg than with BZN 60d/300mg. A 24-month recruitment period is planned in four hospitals with 23,436 deliveries in 2015 and frequencies of T. cruzi seropositive women varying from 1.5% to 4.8%. The investigators are planning to enroll 600 T. cruzi seropositive women.

NCT ID: NCT03671148 Active, not recruiting - Clinical trials for Psoriatic Arthritis (PsA)

A Study Comparing Risankizumab to Placebo in Participants With Active Psoriatic Arthritis Including Those Who Have a History of Inadequate Response or Intolerance to Biologic Therapy(Ies)

KEEPsAKE2
Start date: March 7, 2019
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of risankizumab in adults with moderately to severely active psoriatic arthritis (PsA).