303 matching studies

Sponsor Condition of Interest
A Study to Investigate the Efficacy and Safety of RO5285119 in Participants With Autism Spectrum Disorder...
Hoffmann-La Roche Autism Spectrum Disorder
This is a Phase II multi-center, randomized, double-blind, 24-week, 3-arm, parallel group, placebo-controlled study to investigate the efficacy, safety, and pharmacokinetics of RO5285119 in children and adolescents aged 5-17 years with ASD who are high functioning (intelligence... expand

This is a Phase II multi-center, randomized, double-blind, 24-week, 3-arm, parallel group, placebo-controlled study to investigate the efficacy, safety, and pharmacokinetics of RO5285119 in children and adolescents aged 5-17 years with ASD who are high functioning (intelligence quotient [IQ] greater than or equal to [>=] 70). Enrollment will be staggered, starting first with adolescents (aged 13 to 17 years) and then with children (aged 5 to 12 years). Initially, a first cohort of approximately 24 adolescents will be enrolled together. Based on pharmacokinetic evaluation, safety, and tolerability in the first adolescent cohort and determined final doses, enrollment of adolescents will resume and the enrollment of a first cohort of approximately 24 children (aged 5 to 12 years) can commence. Based on acceptable safety and tolerability in the first children cohort and determined final doses, enrollment of children will resume.

Type: Interventional

Start Date: Nov 2016

open study

A Study of Brexpiprazole Plus Ketamine in Treatment-Resistant Depression (TRD)
Massachusetts General Hospital Depression
This is a multi-site, double-blind, placebo-controlled study of the acute efficacy of brexpiprazole or placebo in combination with intranasal ketamine added to ongoing, stable, and adequate antidepressant therapy (ADT) in the treatment of adults with Major Depressive Disorder... expand

This is a multi-site, double-blind, placebo-controlled study of the acute efficacy of brexpiprazole or placebo in combination with intranasal ketamine added to ongoing, stable, and adequate antidepressant therapy (ADT) in the treatment of adults with Major Depressive Disorder with Treatment Resistant Depression.

Type: Interventional

Start Date: Sep 2017

open study

Central Mechanisms That Regulate Glucose Metabolism in Humans
Albert Einstein College of Medicine, Inc. Type 2 Diabetes
Increased endogenous glucose production (EGP) is the major cause of postabsorptive hyperglycemia in type 2 diabetes mellitus (T2DM). While EGP is inhibited by both glucose and insulin in non-diabetic animals and humans, T2DM is associated with increased EGP despite elevated plasma... expand

Increased endogenous glucose production (EGP) is the major cause of postabsorptive hyperglycemia in type 2 diabetes mellitus (T2DM). While EGP is inhibited by both glucose and insulin in non-diabetic animals and humans, T2DM is associated with increased EGP despite elevated plasma glucose and insulin concentrations. In fact, we and others have reported direct inhibitory effects of hyperglycemia itself on EGP in nondiabetic subjects, independent of other hormonal or metabolic signals, which are markedly blunted in subjects with T2DM. The medial hypothalamus mediates hormonal signals which affect glucose metabolism. ATP-sensitive potassium (KATP) channels are expressed in the hypothalamus and can be activated by insulin. Activation of these channels appears to be an important common mechanism whereby both systemic glucose and insulin suppress EGP, and may account for almost 50% of EGP suppression by both agents. Diazoxide has been shown to inhibit EGP in rodents via the activation of these KATP channels in the hypothalamus, while the KATP channel inhibitor glyburide blocks these effects. There is evidence to suggest that central activation of KATP channels is still able to suppress EGP in animal models that are otherwise resistant to the effects of systemic glucose and insulin.

Type: Interventional

Start Date: May 2011

open study

Study of Acarbose in Longevity
Montefiore Medical Center Aging
The investigators are studying the effects of acarbose on muscle and adipose gene transcription in older adults. expand

The investigators are studying the effects of acarbose on muscle and adipose gene transcription in older adults.

Type: Interventional

Start Date: Nov 2016

open study

Tabelecleucel for Allogeneic Hematopoietic Cell Transplant Subjects With EBV+ PTLD After Failure of Rituximab
Atara Biotherapeutics Epstein-Barr Virus-Related Post-Transplant Lymphoproliferative Disorder
This is a multicenter, open label, single-arm, phase 3 study to assess the efficacy and safety of tabelecleucel for the treatment of Epstein-Barr Virus-associated post-transplant lymphoproliferative disease (EBV+ PTLD) in the setting of allogeneic hematopoietic cell transplant... expand

This is a multicenter, open label, single-arm, phase 3 study to assess the efficacy and safety of tabelecleucel for the treatment of Epstein-Barr Virus-associated post-transplant lymphoproliferative disease (EBV+ PTLD) in the setting of allogeneic hematopoietic cell transplant (HCT) after failure of rituximab.

Type: Interventional

Start Date: Dec 2017

open study

Efficacy, Safety, and Tolerability Study of Oral Full-Spectrum MicrobiotaTM (CP101) in Subjects With...
Finch Research and Development LLC. Clostridium Difficile Infection Recurrence
This is a Multicenter, Double-Blind, Parallel-Arm, Placebo-Controlled, Phase 2 Study of the Efficacy, Safety, and Tolerability of Oral Full-Spectrum MicrobiotaTM (CP101) in Subjects with Recurrence of Clostridium difficile Infection expand

This is a Multicenter, Double-Blind, Parallel-Arm, Placebo-Controlled, Phase 2 Study of the Efficacy, Safety, and Tolerability of Oral Full-Spectrum MicrobiotaTM (CP101) in Subjects with Recurrence of Clostridium difficile Infection

Type: Interventional

Start Date: May 2017

open study

Connecting Youth and Young Adults to Optimize ART Adherence: YouTHrive Efficacy Trial
University of Minnesota - Clinical and Translational Science Institute HIV Infections
YouTHrive (YT) is a two-arm randomized control trial (RCT) to test the efficacy of an adapted version of the Thrive With Me (TWM) intervention for youth living with HIV (YLWH). In the RCT, intervention participants will have access to the full YouTHrive (YT) website- a mobile-enhanced... expand

YouTHrive (YT) is a two-arm randomized control trial (RCT) to test the efficacy of an adapted version of the Thrive With Me (TWM) intervention for youth living with HIV (YLWH). In the RCT, intervention participants will have access to the full YouTHrive (YT) website- a mobile-enhanced private social networking website aimed at improving medication adherence for YLWH. The investigators will enroll up to 60 YLWH for formative work on YT, and 300 YLWH (15-24 years old) of all genders with a detectable viral load (VL) across six cities and randomize them to either the intervention condition or control condition. Assessments will be collected at baseline, 5, 8, and 11-month follow-up.

Type: Interventional

Start Date: May 2017

open study

Study of Oral Treprostinil in Subjects With Pulmonary Hypertension (PH) Associated With Heart Failure...
United Therapeutics Pulmonary Hypertension Associated With HFpEF
This is an open-label study to evaluate the safety of continued therapy with oral treprostinil in subjects who have completed Study TDE-HF-301. This study will provide long-term, open-label data regarding the effect of continued long-term oral treprostinil therapy for the treatment... expand

This is an open-label study to evaluate the safety of continued therapy with oral treprostinil in subjects who have completed Study TDE-HF-301. This study will provide long-term, open-label data regarding the effect of continued long-term oral treprostinil therapy for the treatment of pulmonary hypertension (PH) associated with heart failure with preserved ejection fraction (HFpEF). Subject visits will occur at Baseline, Weeks 6, 12, 18, 24, and every 12 weeks thereafter until either oral treprostinil becomes commercially available to treat PH associated with HFpEF or the study is discontinued by the Sponsor.

Type: Interventional

Start Date: Aug 2017

open study

An Efficacy and Safety Study of JNJ-56021927 (Apalutamide) in High-risk Prostate Cancer Subjects Receiving...
Aragon Pharmaceuticals, Inc. Prostatic Neoplasms
The purpose of this study is to determine if apalutamide plus gonadotropin releasing hormone (GnRH) agonist in participants with high-risk, localized or locally advanced prostate cancer receiving primary radiation therapy results in an improvement of metastasis-free survival. expand

The purpose of this study is to determine if apalutamide plus gonadotropin releasing hormone (GnRH) agonist in participants with high-risk, localized or locally advanced prostate cancer receiving primary radiation therapy results in an improvement of metastasis-free survival.

Type: Interventional

Start Date: Nov 2015

open study

A Randomized Trial to Assess Patient Quality of Life and Function After Alternative Surgeries for Pathologic...
Memorial Sloan Kettering Cancer Center Proximal Femoral Metastases
The purpose of this study is to look at two different types of surgeries regularly used for treating cancer that has spread to and weakened the thigh bone (femur). Because it is not known which of these surgeries is best, the investigators will compare the results of the two... expand

The purpose of this study is to look at two different types of surgeries regularly used for treating cancer that has spread to and weakened the thigh bone (femur). Because it is not known which of these surgeries is best, the investigators will compare the results of the two procedures. They are looking to see if differences exist (after surgery) in function, quality of life, pain control, and possible complications.

Type: Interventional

Start Date: Jun 2014

open study

The OLYMPUS Study - Optimized DeLivery of Mitomycin for Primary UTUC Study
UroGen Pharma Ltd. Carcinoma, Transitional Cell
The study is investigating the ability of UroGen's MitoGel™ procedure to treat urothelial carcinoma tumors from the upper urinary tract. If this treatment will prove to be effective this will lead to the development of a new treatment approach for patients suffering from Low... expand

The study is investigating the ability of UroGen's MitoGel™ procedure to treat urothelial carcinoma tumors from the upper urinary tract. If this treatment will prove to be effective this will lead to the development of a new treatment approach for patients suffering from Low Grade Upper Urinary Urothelial Carcinoma (UTUC).

Type: Interventional

Start Date: Apr 2017

open study

Combination Chemotherapy in Treating Young Patients With Newly Diagnosed High-Risk B Acute Lymphoblastic...
National Cancer Institute (NCI) B Acute Lymphoblastic Leukemia Central Nervous System Leukemia Ph-Like Acute Lymphoblastic Leukemia Testicular Leukemia Untreated Adult Acute Lymphoblastic Leukemia
This randomized phase III trial studies how well combination chemotherapy works in treating young patients with newly diagnosed B acute lymphoblastic leukemia that is likely to come back or spread, and in patients with Philadelphia chromosome (Ph)-like tyrosine kinase inhibitor... expand

This randomized phase III trial studies how well combination chemotherapy works in treating young patients with newly diagnosed B acute lymphoblastic leukemia that is likely to come back or spread, and in patients with Philadelphia chromosome (Ph)-like tyrosine kinase inhibitor (TKI) sensitive mutations. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug (combination chemotherapy) and giving the drugs in different doses and in different combinations may kill more cancer cells.

Type: Interventional

Start Date: Feb 2012

open study

The Modifying the Impact of ICU-Associated Neurological Dysfunction-USA (MIND-USA) Study
Vanderbilt University Delirium Impaired Cognition Long Term Psychologic Disorders
The long-term objective of the MIND-USA (Modifying the Impact of ICU-Induced Neurological Dysfunction-USA) Study is to define the role of antipsychotics in the management of delirium in vulnerable critically ill patients. We and others have shown that delirium is an independent... expand

The long-term objective of the MIND-USA (Modifying the Impact of ICU-Induced Neurological Dysfunction-USA) Study is to define the role of antipsychotics in the management of delirium in vulnerable critically ill patients. We and others have shown that delirium is an independent predictor of more death, longer stay, higher cost, and long-term cognitive impairment often commensurate with moderate dementia. The rapidly expanding aging ICU population is especially vulnerable to develop delirium, with 7 of 10 medical and surgical ICU patients developing this organ dysfunction. Antipsychotics are the first-line pharmacological agents recommended to treat delirium, and over the past 30 years they gained widespread use in hospitalized patients globally prior to adequate testing of efficacy and safety for this indication. Haloperidol, the most commonly chosen antipsychotic, is used by over 80% of ICU doctors for delirium, while atypical antipsychotics are prescribed by 40%. Antipsychotics safety concerns include lethal cardiac arrhythmias, extrapyramidal symptoms, and the highly publicized increased mortality associated with their use in non-ICU geriatric populations. The overarching hypothesis is that administration of typical and atypical antipsychotics—haloperidol and ziprasidone, in this case—to critically ill patients with delirium will improve short- and long-term clinical outcomes, including days alive without acute brain dysfunction (referred to as delirium/coma-free days or DCFDs) over a 14-day period; 30-day, 90-day, and 1-year survival; ICU length of stay; incidence, severity, and/or duration of long-term neuropsychological dysfunction; and quality of life at 90-day and 1-year. To test these hypotheses, the MIND-USA Study will be a multi-center, double-blind, randomized, placebo-controlled investigation in 561 critically ill, delirious medical/surgical ICU patients who are (a) on mechanical ventilation or non-invasive positive pressure ventilation or (b) in shock on vasopressors. In each group (haloperidol, ziprasidone, and placebo), 187 patients will be enrolled and treated until delirium has resolved for 48 hours or to 14 days (whichever occurs first) and followed for 1 year.

Type: Interventional

Start Date: Dec 2011

open study

A Clinical Trial of Omalizumab in Participants With Chronic Rhinosinusitis With Nasal Polyps
Hoffmann-La Roche Nasal Polyps Chronic Rhinosinusitis
The purpose of this study is to determine the efficacy and safety of omalizumab compared with placebo in adult participants with chronic rhinosinusitis with nasal polyps (CRSwNP) who have had an inadequate response to standard-of-care treatments. expand

The purpose of this study is to determine the efficacy and safety of omalizumab compared with placebo in adult participants with chronic rhinosinusitis with nasal polyps (CRSwNP) who have had an inadequate response to standard-of-care treatments.

Type: Interventional

Start Date: Nov 2017

open study

Pharmacokinetics and Pharmacodynamics Study of SEG101 (Crizanlizumab) in Adult Sickle Cell Disease (SCD)...
Novartis Pharmaceuticals Sickle Cell Disease
The purpose of the CSEG101A2202 study is to characterize the PK and PD of SEG101 at 5 mg/kg and to evaluate the safety and efficacy of SEG101. Study CSEG101A2202 is designed as a Phase II, multicenter, open-label study. Up to 45 patients (to identify 27 evaluable patients) will... expand

The purpose of the CSEG101A2202 study is to characterize the PK and PD of SEG101 at 5 mg/kg and to evaluate the safety and efficacy of SEG101. Study CSEG101A2202 is designed as a Phase II, multicenter, open-label study. Up to 45 patients (to identify 27 evaluable patients) will be enrolled to the treatment group crizanlizumab 5.0 mg/kg to complete full PK/PD sampling at week 1 and week 15. In all patients, trough PK/PD samples will also be collected prior to each dose. In addition, throughout the study (and when possible), all patients will have blood drawn for serum to assess PK and PD drawn at times of onset and resolution of each VOC event, fever, or suspected infection. Once the up to 45 patients are enrolled, 10 additional patients will be enrolled to the exploratory treatment group and begin at 7.5 mg/kg of crizanlizumab.

Type: Interventional

Start Date: Dec 2017

open study

Afatinib Treatment for Patients With EGFR Mutation Positive NSCLC Who Are Age 70 or Older
Boehringer Ingelheim Carcinoma, Non-Small-Cell Lung ErbB Receptors
Continuous treatment until progression or occurence of intolerable Adverse Event (AE) or end of trial. The end of trial is one year after the last patient has entered the study. expand

Continuous treatment until progression or occurence of intolerable Adverse Event (AE) or end of trial. The end of trial is one year after the last patient has entered the study.

Type: Interventional

Start Date: Aug 2015

open study

A Study to Evaluate the Efficacy and Safety of CC-220 in Subjects With Active Systemic Lupus Erythematosus
Celgene Lupus Erythematosus, Systemic
The purpose of this Phase 2, multicenter, randomized, placebo-controlled, double-blind study to evaluate the efficacy and safety of an oral treatment regimen of CC-220 versus placebo in adult subjects with active systemic lupus erythematosus. Approximately 280 subjects with... expand

The purpose of this Phase 2, multicenter, randomized, placebo-controlled, double-blind study to evaluate the efficacy and safety of an oral treatment regimen of CC-220 versus placebo in adult subjects with active systemic lupus erythematosus. Approximately 280 subjects with a documented diagnosis of SLE will be randomized 2:2:1:2 to receive CC-220 (0.45 mg QD, 0.3 mg QD or 0.15 mg QD) or identically appearing placebo.

Type: Interventional

Start Date: Jul 2017

open study

Simple Bone Cysts in Kids
The Hospital for Sick Children Bone Cyst
Simple bone cysts (SBCs) are cysts filled with fluid that occur most frequently in the long bones (arms or legs) of children. There are many ways to treat SBCs but it is unclear if one is better than another. The purpose of this research trial is to compare the effectiveness of... expand

Simple bone cysts (SBCs) are cysts filled with fluid that occur most frequently in the long bones (arms or legs) of children. There are many ways to treat SBCs but it is unclear if one is better than another. The purpose of this research trial is to compare the effectiveness of two common treatments that are used by surgeons today.

Type: Interventional

Start Date: Mar 2015

open study

Study to Compare Oral PF-06651600, PF-06700841 and Placebo in Subjects With Moderate to Severe Ulcerative...
Pfizer Ulcerative Colitis
The purpose of this study is to determine whether PF-06651600 and PF-06700841 are effective in treatment of moderate to severe ulcerative colitis. expand

The purpose of this study is to determine whether PF-06651600 and PF-06700841 are effective in treatment of moderate to severe ulcerative colitis.

Type: Interventional

Start Date: Feb 2017

open study

A Study to Assess Whether Macitentan Delays Disease Progression in Children With Pulmonary Arterial Hypertension...
Actelion Pulmonary Arterial Hypertension
This is a prospective, multicenter, open-label, randomized, controlled, parallel group, group-sequential, event-driven Phase 3 study to evaluate efficacy, safety and pharmacokinetics (PK) of macitentan in children. expand

This is a prospective, multicenter, open-label, randomized, controlled, parallel group, group-sequential, event-driven Phase 3 study to evaluate efficacy, safety and pharmacokinetics (PK) of macitentan in children.

Type: Interventional

Start Date: Nov 2017

open study

Lenvatinib/Everolimus or Lenvatinib/Pembrolizumab Versus Sunitinib Alone as Treatment of Advanced Renal...
Eisai Inc. Renal Cell Carcinoma
This is a multicenter, randomized, open-label, Phase 3 study to compare the efficacy and safety of lenvatinib in combination with everolimus (Arm A) or pembrolizumab (Arm B) versus sunitinib (Arm C) as first-line treatment in participants with advanced renal cell carcinoma. expand

This is a multicenter, randomized, open-label, Phase 3 study to compare the efficacy and safety of lenvatinib in combination with everolimus (Arm A) or pembrolizumab (Arm B) versus sunitinib (Arm C) as first-line treatment in participants with advanced renal cell carcinoma.

Type: Interventional

Start Date: Oct 2016

open study

An Investigational Immuno-therapy Study of Nivolumab or Placebo in Patients With Resected Esophageal...
Bristol-Myers Squibb Advanced Cancer
The purpose of this study is to determine whether Nivolumab will improve overall survival, disease-free survival, or both compared with placebo. expand

The purpose of this study is to determine whether Nivolumab will improve overall survival, disease-free survival, or both compared with placebo.

Type: Interventional

Start Date: May 2016

open study

National Collaborative to Improve Care of Children With Complex Congenital Heart Disease
Children's Hospital Medical Center, Cincinnati Hypoplastic Left Heart Syndrome (HLHS)
The purpose of this initiative is to improve care and outcomes for infants with HLHS by expanding the NPC-QIC national registry to gather clinical care process, outcome, and developmental data on infants with HLHS between diagnosis and 12 months of age, by improving the use of... expand

The purpose of this initiative is to improve care and outcomes for infants with HLHS by expanding the NPC-QIC national registry to gather clinical care process, outcome, and developmental data on infants with HLHS between diagnosis and 12 months of age, by improving the use of standards into everyday practice across pediatric cardiology centers, and by engaging parents as partners in the process.

Type: Observational [Patient Registry]

Start Date: May 2016

open study

Safety And Efficacy Study Of Avelumab Plus Chemotherapy With Or Without Other Anti-Cancer Immunotherapy...
Pfizer Non-small Cell Lung Cancer Urothelial Cancer
This is a Phase 1b/2, open label, multicenter, safety and clinical activity study of avelumab in combination with chemotherapy as first-line treatment of adult patients with locally advanced or metastatic solid tumors. Initially, avelumab will be evaluated in combination with... expand

This is a Phase 1b/2, open label, multicenter, safety and clinical activity study of avelumab in combination with chemotherapy as first-line treatment of adult patients with locally advanced or metastatic solid tumors. Initially, avelumab will be evaluated in combination with pemetrexed and carboplatin in patients with advanced non-squamous non-small cell lung cancer (NSCLC) (Cohort A1) and in combination with gemcitabine and cisplatin in patients with cisplatin-eligible urothelial (bladder) cancer (UC) (Cohort A2). As more information is learned about other anti-cancer immunotherapy agents, in future portions of the study, avelumab may be combined with chemotherapy and other anti-cancer immunotherapy agents in patients with these same or different tumor types.

Type: Interventional

Start Date: Dec 2017

open study

A 5-year Longitudinal Observational Study of Patients Undergoing Therapy for Inflammatory Bowel Disease
Target PharmaSolutions, Inc. Inflammatory Bowel Diseases Crohn's Disease Ulcerative Colitis Indeterminate Colitis
TARGET-IBD is a 5-year, longitudinal, observational study of adult and pediatric patients (age 2 and above) being managed for Inflammatory Bowel Disease (IBD) in usual clinical practice. TARGET-IBD will create a research registry of patients with IBD within academic and community... expand

TARGET-IBD is a 5-year, longitudinal, observational study of adult and pediatric patients (age 2 and above) being managed for Inflammatory Bowel Disease (IBD) in usual clinical practice. TARGET-IBD will create a research registry of patients with IBD within academic and community real-world practices in order to assess the safety and effectiveness of current and future therapies.

Type: Observational [Patient Registry]

Start Date: Jul 2017

open study