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NCT ID: NCT03110107 Terminated - Advanced Cancer Clinical Trials

First-In-Human Study of Monoclonal Antibody BMS-986218 by Itself and in Combination With Nivolumab in Participants With Advanced Solid Tumors

Start date: May 4, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to determine whether BMS-986218 both by itself and in combination with Nivolumab is safe and tolerable in the treatment of advanced solid tumors.

NCT ID: NCT03107052 Terminated - Cluster Headache Clinical Trials

A Study to Explore the Long-Term Safety and Efficacy of Fremanezumab (TEV-48125) for the Prevention of Cluster Headache

ENFORCE
Start date: April 27, 2017
Phase: Phase 3
Study type: Interventional

This is a 68-week study to evaluate the long-term safety and efficacy of fremanezumab in participants with cluster headache (CH). Participants who complete the pivotal studies TV48125-CNS-30056 (NCT02945046) and TV48125-CNS-30057 (NCT02964338) and enroll into the current study will visit the investigational center for investigational medicinal product (IMP) administration, safety and efficacy assessments, and blood and urine collections for pharmacokinetics, immunogenicity (anti-drug antibodies [ADAs]), and biomarker analyses. Participants will return to the investigational center for a follow-up visit to evaluate ADAs, fremanezumab concentrations, biomarkers, and safety (adverse events and concomitant medications) approximately 7.5 months after the last dose of IMP.

NCT ID: NCT03105479 Terminated - Clinical trials for Clostridium Difficile Infection

Comparison of Cadazolid Versus Vancomycin in Children With Clostridium Difficile-associated Diarrhea (CDAD)

Start date: April 14, 2017
Phase: Phase 2/Phase 3
Study type: Interventional

Cadazolid has demonstrated activity against a bacteria named Clostridium difficile in animal studies. The results of a first study conducted in adult patients have suggested efficacy of the new antibiotic, cadazolid, in the treatment of diarrhea caused by this bacteria. This is the first study of cadazolid in children. The overall purpose of this study is to provide reassurance on the safety and efficacy of cadazolid in children suffering from infection due to Clostridium difficile.

NCT ID: NCT03095287 Terminated - Clinical trials for Hemophilia A, Congenital

Alphanate in Immune Tolerance Induction Therapy

Start date: January 3, 2018
Phase: Phase 2
Study type: Interventional

This is a multicenter, multinational, prospective, single-arm, nonrandomized, open-label study, planned in of approximately 25 male participants with congenital hemophilia A who will receive their first (primary) immune tolerance induction (ITI) treatment with alphanate. The study consists of 2 phases: - An ITI Treatment Phase in which all eligible participants will receive ITI treatment with alphanate for a period of up to 33 months. Upon confirmation of complete immune tolerization, participants will then enter a 12-month Prophylactic Phase. If, after 33 months of ITI, a participants has achieved partial immune tolerance, the participants will enter a 12-month Prophylactic Phase. - A 12-month Prophylactic Phase for all participants who meet the criteria for complete or partial success to continue on a prophylactic dosing regimen of alphanate. Due to limited enrollment, this study was early terminated.

NCT ID: NCT03094832 Terminated - Clinical trials for PIK3CA-Related Overgrowth Spectrum (PROS)/Proteus Syndrome

Study of Miransertib (MK-7075) in Participants With PIK3CA-related Overgrowth Spectrum and Proteus Syndrome (MOSAIC) (MK-7075-002)

MOSAIC
Start date: May 16, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

This is an open label, Phase 1/2 study of oral miransertib (MK-7075) administered to participants at least 2 years of age with phosphatidylinositol-4,5-bisphosphate 3-kinase, catalytic subunit alpha (PIK3CA)-related Overgrowth Spectrum (PROS) and Proteus Syndrome (PS) (MOSAIC).

NCT ID: NCT03094715 Terminated - Stroke, Acute Clinical Trials

Efficacy and Safety of Thrombectomy in Stroke With Extended Lesion and Extended Time Window

Tension
Start date: June 20, 2018
Phase: N/A
Study type: Interventional

TENSION (Efficacy and safety of ThrombEctomy iN Stroke with extended leSION and extended time window) is a prospective, open label, blinded endpoint (PROBE), European two-arm, randomized, controlled, post-market study to compare the safety and effectiveness of endovascular thrombectomy as compared to best medical care alone in the treatment of acute ischemic stroke patients with extended stroke lesions defined by an Alberta Stroke Program Early CT Score (ASPECTS) score of 3-5 and in an extended time window (up to 12 hours or unknown time of symptom onset). Up to 665 subjects will be randomized. Primary endpoint will be functional outcome assessed by the modified Rankin scale at 90 days post-stroke ("mRS shift analysis"). By this, TENSION will provide evidence of efficacy and safety of thrombectomy in an acute stroke population with uncertain benefit of endovascular stroke treatment.

NCT ID: NCT03094195 Terminated - Clinical trials for Post-herpetic Neuralgia

Dose Response Study of EMA401 in Patients With Post-herpetic Neuralgia (PHN)

EMPHENE
Start date: June 27, 2017
Phase: Phase 2
Study type: Interventional

This study was designed to characterize dose response, and evaluate safety and efficacy of three different doses of EMA401 compared to placebo in patients with post-herpetic neuralgia (PHN).

NCT ID: NCT03088735 Terminated - Infertility, Female Clinical Trials

Transfer Strategy in an Oocyte Donation Programme

Start date: April 5, 2017
Phase: N/A
Study type: Interventional

It has been previously shown that although the activation of the embryonic genome can begin as early as two days of initiation of the embryonic development (D2), it is expressed on day 3 (D3). Without this activation, the embryo can not continue its development. Therefore, it has been suggested that extended culture to blastocyst stage could be an option to identify and better select embryos that have been able to carry out this activation. The purpose of this study is to compare cumulative pregnancy and live birth rates following transfer of cleavage embryos or blastocysts.

NCT ID: NCT03084861 Terminated - Clinical trials for Neurotrophic Keratopathy

A Clinical Trial to Asses Efficacy and Safety of Cord Blood Eye Drops in Neurotrophic Keratopathy

Start date: February 24, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

This is a multicenter, randomized, open-label, two-arms phase I/II, clinical trial, in which 42 patients will be enrolled with the principal objective to evaluate the efficacy through changes in lesion size and, secondary, to evaluate the safety and efficacy through corneal sensibility, corneal opacity, visual acuity and complications of Neurotrophic Keratopathy (NK). Patients will be randomized 1:1 to receive experimental treatment (cord blood eye drops) or conventional treatment (artificial tears and therapeutic contact lens).

NCT ID: NCT03071692 Terminated - Dyslipidemia Clinical Trials

Pemafibrate to Reduce Cardiovascular OutcoMes by Reducing Triglycerides IN patiENts With diabeTes (PROMINENT)

PROMINENT
Start date: March 23, 2017
Phase: Phase 3
Study type: Interventional

The primary objective of the study is to determine whether pemafibrate administered twice daily will delay the time to first occurrence of any component of the clinical composite endpoint of: - nonfatal Myocardial Infarction (MI) - nonfatal ischemic stroke - coronary revascularization; or - Cardio Vascular (CV) death.