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NCT ID: NCT02535377 Completed - Fertility Clinical Trials

Human Sperm Markers of Cryodamage Resistance

Start date: February 12, 2015
Phase:
Study type: Observational

Sperm freezing has been employed for decades for male fertility preservation in cases of foreseeable or unexpected loss of fertility to guarantee future paternity, and also as a complement of assisted reproduction techniques. Sperm quality after thawing is highly variable, even among consecutive samples from the same individual, with mean survival rates around 40%. To date, the molecular basis of the adequate resistance or intolerance to freezing/thawing protocols is unknown, and its knowledge can lead to improvement in the selection of the samples to be frozen and also in the adequate supplement of cryopreservation media. Microarray analysis provides a powerful tool to address the molecular explanation beyond this behaviour, yielding results about comparative messenger ribonucleic acid (mRNA)expression under the two different biological conditions: optimal and suboptimal survival. Then, the aim of the investigators' study is to determine the genomic profile of sperm samples depending on their survival resistance to cryopreservation, to determine genes involved in cryodamage sensitivity.

NCT ID: NCT02535091 Completed - Partial Epilepsy Clinical Trials

Safety and Pharmacokinetic Study of YKP3089 as Adjunctive Therapy in Subjects With Partial Onset Seizures

Start date: August 3, 2016
Phase: Phase 3
Study type: Interventional

This is a multicenter, open label study to assess the safety and pharmacokinetics of YKP3089 as adjunctive therapy in subjects with partial onset seizures. Initially, subjects taking phenytoin or phenobarbital will be enrolled followed by additional subjects taking anti-epileptic drugs (AED) other than phenytoin and phenobarbital to further investigate long-term safety.

NCT ID: NCT02534844 Completed - Clinical trials for Niemann-Pick Disease, Type C

VTS-270 to Treat Niemann-Pick Type C1 (NPC1) Disease

Start date: October 2015
Phase: Phase 2/Phase 3
Study type: Interventional

Due to different study designs, the sponsor separated Part C into a separate registration (NCT04958642), leaving Parts A/B here in NCT02534844. This study is to find out how safe and effective VTS-270 is for patients with Niemann-Pick Type C1 (NPC1) disease who have neurologic symptoms (listed under Keywords). In Parts A/B, two out of every three patients will receive the study drug. The third patient will receive 1 to 2 small needle pricks at the location where the LP and IT injection is normally made (sham control). In Part C, all participants will receive study drug, as described in the Part C registration record. Start date for this record is the first day a participant was enrolled in Parts A/B. The trial is actually continuing until the last primary outcome measure of safety data are collected from Part C participants. The last primary outcome measure of safety, along with final adverse events results will be posted in the separate Part C registration record.

NCT ID: NCT02534363 Completed - Schizophrenia Clinical Trials

Neurocognitive Effectiveness in Treatment of First-episode Non-affective Psychosis: 1-year Follow-up

PAFIP2_nc1Y
Start date: October 2005
Phase: Phase 4
Study type: Interventional

Cognitive enhancement is a primary goal in treating individuals with schizophrenia. Cognitive deficits are already present at the first break of the illness, seem to remain stable during early phases and noticeably influence daily functioning. Differences among antipsychotics in terms of cognitive effectiveness have turned out to be a topic of increasing research interest. The initially postulated superior neurocognitive effectiveness of second-generation antipsychotics (SGAs) compared to first-generation antipsychotics (FGAs) is currently under debate. Long-term studies would be of great value to evaluate the differential benefits exerted by antipsychotic drugs on cognitive performance. The aim of this study is to investigate the cognitive effects of aripiprazole, quetiapine and ziprasidone in first-episode psychosis at 1 year.

NCT ID: NCT02533674 Completed - Solid Tumors Clinical Trials

Multicenter, Open-label, Clinical and Pharmacokinetic Study of PM060184 in Combination With Gemcitabine in Selected Patients With Advanced Solid Tumors

Start date: December 12, 2014
Phase: Phase 1
Study type: Interventional

Prospective, open-label, dose-ranging, uncontrolled phase I study with escalating doses of PM060184 in combination with gemcitabine in selected patients with advanced solid tumors. The study objectives are: To determine the MTD and the RD of PM060184 in combination with gemcitabine in selected patients with advanced solid tumors. To characterize the safety profile and feasibility of this combination in this study population. To characterize the pharmacokinetics of this combination and to detect major drug-drug PK interactions. To obtain preliminary information on the clinical antitumor activity of this combination.

NCT ID: NCT02533479 Completed - Clinical trials for Dietary Modification

Erythrocytes and Skeletal-muscle Fatty Acids Are Positively Correlated After Caloric Restriction and Exercise

Start date: January 2010
Phase: N/A
Study type: Interventional

The aim is compare and correlate skeletal muscle and erythrocytes fatty acids (FAs) profiles in adult healthy human after caloric restriction and acute exercise in order to validate erythrocyte FAs profile as marker of changes in muscle fatty acid composition.

NCT ID: NCT02532764 Completed - Cystic Fibrosis Clinical Trials

Dose Escalation Study of QR-010 in Homozygous ΔF508 Cystic Fibrosis Patients

Start date: June 2015
Phase: Phase 1/Phase 2
Study type: Interventional

A randomized, double-blind, placebo-controlled study of single and multiple ascending doses of QR-010 in adults homozygous for ΔF508 Cystic Fibrosis.

NCT ID: NCT02532283 Completed - Influenza A Virus Clinical Trials

A Study to Evaluate the Pharmacokinetics, Safety, and Antiviral Activity of JNJ-63623872 in Combination With Oseltamivir in Adult, and Elderly Hospitalized Participants With Influenza A Infection

Start date: December 11, 2015
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the Pharmacokinetic parameters of JNJ-63623872 in combination with oseltamivir in elderly participants (aged 65 to <= 85 years) compared to adults (aged 18 to <= 64 years) with influenza A infection.

NCT ID: NCT02531438 Completed - Bacterial Pneumonia Clinical Trials

Omadacycline vs Moxifloxacin for the Treatment of CABP (EudraCT #2013-004071-13)

Start date: November 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of omadacycline as compared to moxifloxacin in the treatment of adults with community-acquired bacterial pneumonia.

NCT ID: NCT02531035 Completed - Clinical trials for Type 1 Diabetes Mellitus (T1DM)

A Phase 3 Study to Evaluate the Safety of Sotagliflozin in Patients With Type 1 Diabetes Who Have Inadequate Glycemic Control With Insulin Therapy Alone

inTandem3
Start date: September 2015
Phase: Phase 3
Study type: Interventional

This Phase 3 study was designed to demonstrate the net benefit of sotagliflozin versus placebo in patients with Type 1 Diabetes (T1D).