306 matching studies

Sponsor Condition of Interest
Study of Voicing My CHOiCES as a Tool for Advanced Care Planning in Young Adults With Cancer
National Cancer Institute (NCI) HIV Cancer Chronic Granulomatous Disease Dock 8 Deficiency
Background: - There are very few documents to help young adults living with advanced cancer discuss their concerns and end-of-life preferences. A new document, Voicing My CHOiCES, allows young adults to explain what kind of care they would want if they became unable to communicate... expand

Background: - There are very few documents to help young adults living with advanced cancer discuss their concerns and end-of-life preferences. A new document, Voicing My CHOiCES, allows young adults to explain what kind of care they would want if they became unable to communicate or make medical decisions on their own. Researchers want to study if this document is helpful. Objective: - To study if Voicing My CHOiCES can reduce anxiety, improve sense of support, and improve communication about advanced care planning. Eligibility: - Adults 18 to 39 years old being treated for cancer. Design: - Participants will answer questions about their age, gender, employment, religion, health, and marital status. They will also complete several brief questionnaires: 1. General Anxiety Short Form 2. Peace, Equanimity and Acceptance in the Cancer Experience 3. Functional Assessment of Social Support 4. Quality of Communication 5. Prior Communication about Advanced Care Planning - Then a health care professional will introduce Voicing My CHOiCES . Participants will review the document and comment on parts they find relevant. They will also say if any important items are missing. Participants will complete 3 pages of the document with the assistance of a health care provider. They will be asked for positive and negative observations. - The second stage of the study will take place about 1 month later. Participants will repeat the brief questionnaires listed above. They will be asked if they shared any of the preferences they described when completing the 3 pages of Voicing My CHOiCES during visit 1 with a family member, friend, or health care provider. Research staff will ask the participant for permission to contact the people they spoke with in order to learn whether their conversations about the document were helpful. They will ask for feedback on how to make Voicing My CHOiCES more helpful.

Type: Observational

Start Date: Apr 2014

open study

Study of M3814 in Combination With Capecitabine and Radiotherapy in Rectal Cancer
EMD Serono Research & Development Institute, Inc. Locally Advanced Rectal Cancer
The main purpose of the study is to define maximum tolerated dose (MTD), recommended Phase II dose (RP2D) of M3814 in combination with capecitabine and radiotherapy (RT) in Phase Ib and to evaluate the efficacy of M3814 in terms of Pathological Clinical Response (pCR)/Clinical... expand

The main purpose of the study is to define maximum tolerated dose (MTD), recommended Phase II dose (RP2D) of M3814 in combination with capecitabine and radiotherapy (RT) in Phase Ib and to evaluate the efficacy of M3814 in terms of Pathological Clinical Response (pCR)/Clinical Complete Response (cCR) when administered in combination with capecitabine and RT versus placebo, capecitabine, and RT in Phase II.

Type: Interventional

Start Date: Mar 2019

open study

Evaluation of Patient Outcomes From the Kidney Allograft Outcomes AlloSure Registry
CareDx Kidney Transplant Rejection
This is an observational study to evaluate safety and efficacy outcomes in renal transplant recipients in whom post-transplant care is managed using AlloSure®. AlloSure® is a non-invasive test to measure donor-derived cell-free DNA (dd-cfDNA). The AlloSure test is intended to... expand

This is an observational study to evaluate safety and efficacy outcomes in renal transplant recipients in whom post-transplant care is managed using AlloSure®. AlloSure® is a non-invasive test to measure donor-derived cell-free DNA (dd-cfDNA). The AlloSure test is intended to assess the probability of allograft rejection in kidney transplant recipients with clinical suspicion of rejection and to inform clinical decision-making regarding the necessity of renal biopsy in such patients at least 2 weeks post-transplant in conjunction with standard clinical assessment. Amendment 1 (A1): Is an observational study to develop and validate the clinical use of KidneyCare®.

Type: Observational

Start Date: Jan 2018

open study

Disrupt CAD III With the Shockwave Coronary IVL System
Shockwave Medical, Inc. Coronary Artery Disease Myocardial Infarction
The study design is a prospective, multicenter, single-arm, global IDE study to evaluate the safety and effectiveness of the Shockwave Medical Coronary Intravascular Lithotripsy (IVL) System in de novo, calcified, stenotic coronary arteries prior to stenting. Disrupt CAD III... expand

The study design is a prospective, multicenter, single-arm, global IDE study to evaluate the safety and effectiveness of the Shockwave Medical Coronary Intravascular Lithotripsy (IVL) System in de novo, calcified, stenotic coronary arteries prior to stenting. Disrupt CAD III is being conducted as a staged pivotal study.

Type: Interventional

Start Date: Jan 2019

open study

Collection and Storage of Tissue and Blood Samples From Patients With Cancer
National Cancer Institute (NCI) Lymphoma Malignant Neoplasm Malignant Solid Neoplasm Metastatic Malignant Solid Neoplasm Plasma Cell Leukemia
This research trial collects and stores tissue and blood samples from patients with cancer. Collecting and storing samples of tissue and blood from patients with cancer to study in the laboratory may help scientists create new and better models to learn about cancer and to test... expand

This research trial collects and stores tissue and blood samples from patients with cancer. Collecting and storing samples of tissue and blood from patients with cancer to study in the laboratory may help scientists create new and better models to learn about cancer and to test new cancer drugs.

Type: Observational

Start Date: May 2015

open study

Evaluation of VISITAG SURPOINT™ Module With External Processing Unit (EPU)
Biosense Webster, Inc. Paroxysmal Atrial Fibrillation
Prospective, non-randomized, post market clinical evaluation of the VISITAG SURPOINT™ Module with External Processing Unit (EPU) when used with STSF catheter and ST catheter compared to an historical control performance goal. A maximum of 330 subjects will be enrolled across... expand

Prospective, non-randomized, post market clinical evaluation of the VISITAG SURPOINT™ Module with External Processing Unit (EPU) when used with STSF catheter and ST catheter compared to an historical control performance goal. A maximum of 330 subjects will be enrolled across up to 45 sites. Two hundred eighty (280) enrolled subjects will be treated using the STSF catheter with EPU and 50 subjects will be treated using the ST catheter with EPU. Prior to enrollment, a few sites will be selected to only enroll subjects who will be treated with the ST catheter and the remaining sites will only enroll subjects who will be treated with the STSF catheter. Bayesian adaptive design will be used to assess early success at up to two interims: one after all subjects have completed the 3- month follow-up assessment, and a second to occur after all subjects have completed the 6 months follow-up visit.

Type: Interventional

Start Date: Sep 2018

open study

Connecting Youth and Young Adults to Optimize ART Adherence: YouTHrive Efficacy Trial
University of Minnesota 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 living in seven 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

A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely...
AbbVie Crohn's Disease
The objective of this study is to evaluate the efficacy and safety of upadacitinib compared to placebo as induction therapy in subjects with moderately and severely active Crohn's disease (CD). expand

The objective of this study is to evaluate the efficacy and safety of upadacitinib compared to placebo as induction therapy in subjects with moderately and severely active Crohn's disease (CD).

Type: Interventional

Start Date: Nov 2017

open study

Efficacy and Safety of AG10 in Subjects With Transthyretin Amyloid Cardiomyopathy
Eidos Therapeutics Amyloidosis Amyloid Cardiomyopathy Transthyretin Amyloidosis Cardiomyopathies Heart Diseases
Phase 3 efficacy and safety study to evaluate AG10 800 mg compared to placebo in subjects with symptomatic Transthyretin Amyloid Cardiomyopathy (ATTR-CM) expand

Phase 3 efficacy and safety study to evaluate AG10 800 mg compared to placebo in subjects with symptomatic Transthyretin Amyloid Cardiomyopathy (ATTR-CM)

Type: Interventional

Start Date: Mar 2019

open study

Dose-escalation Study of Intravenous Liposomal Vinorelbine Tartrate Injection in Patients With Advanced...
Taiwan Liposome Company Cancer
This is a phase I/IIa, Open label, Dose-escalation Study Investigating the Safety, Tolerability, and Pharmacokinetics of Intravenous Liposomal Vinorelbine Tartrate Injection in Patients with Advanced Malignancy. expand

This is a phase I/IIa, Open label, Dose-escalation Study Investigating the Safety, Tolerability, and Pharmacokinetics of Intravenous Liposomal Vinorelbine Tartrate Injection in Patients with Advanced Malignancy.

Type: Interventional

Start Date: Jun 2017

open study

Study Evaluating the Efficacy and Safety of Obeticholic Acid in Subjects With Compensated Cirrhosis Due...
Intercept Pharmaceuticals Compensated Cirrhosis Nonalcoholic Steatohepatitis
The primary objective of this study is to evaluate whether obeticholic acid (OCA; INT-747) can lead to histological improvement in fibrosis with no worsening of NASH in adults with compensated cirrhosis due to NASH. expand

The primary objective of this study is to evaluate whether obeticholic acid (OCA; INT-747) can lead to histological improvement in fibrosis with no worsening of NASH in adults with compensated cirrhosis due to NASH.

Type: Interventional

Start Date: Aug 2017

open study

Intranasal Oxytocin vs. Placebo for the Treatment of Hyperphagia in Prader-Willi Syndrome
Montefiore Medical Center Prader-Willi Syndrome Hyperphagia
This study is a phase 2 randomized double blind 8-week treatment trial of intranasal OXT vs. placebo in 50 subjects aged 5 to 17 years with PWS in order to assess IN-OXT's affect on measurements of (1) eating behaviors (2) repetitive behaviors (3) weight and body composition... expand

This study is a phase 2 randomized double blind 8-week treatment trial of intranasal OXT vs. placebo in 50 subjects aged 5 to 17 years with PWS in order to assess IN-OXT's affect on measurements of (1) eating behaviors (2) repetitive behaviors (3) weight and body composition (4) quality of life (5) salivary OXT and hormone levels (including ghrelin, pancreatic polypeptide, peptide YY, GLP-1, insulin, glucagon, testosterone, and estrogen). If superior to placebo, this data will add to the current knowledge that OXT is an effective treatment for hyperphagia as well as other symptoms of PWS. Funding Source- FDA OOPD

Type: Interventional

Start Date: Apr 2018

open study

MILD® Percutaneous Image-Guided Lumbar Decompression: A Medicare Claims Study
Vertos Medical, Inc. Lumbar Spinal Stenosis
This prospective longitudinal study will compare incidence rates of Medicare beneficiary surgical and minimally invasive intervention post index procedure, as well as harms associated with the MILD procedure, at 24 months post-treatment with MILD, tested against a control group... expand

This prospective longitudinal study will compare incidence rates of Medicare beneficiary surgical and minimally invasive intervention post index procedure, as well as harms associated with the MILD procedure, at 24 months post-treatment with MILD, tested against a control group of similar patients that have had a comparable procedure.

Type: Observational

Start Date: Mar 2017

open study

A Study to Investigate BAY2402234, a Dihydroorotate Dehydrogenase (DHODH) Inhibitor, in Myeloid Malignancies
Bayer Leukemia
The primary objective is to determine the safety, tolerability, pharmacokinetics, maximum tolerated dose (MTD), or pharmacological active dose (PAD) of BAY2402234 in patients with acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), or chronic myelomonocytic leukemia... expand

The primary objective is to determine the safety, tolerability, pharmacokinetics, maximum tolerated dose (MTD), or pharmacological active dose (PAD) of BAY2402234 in patients with acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), or chronic myelomonocytic leukemia (CMML). The secondary objective is to evaluate evidence of clinical efficacy associated with BAY2402234 in patients with AML (defined as Complete remission, Complete remission with partial hematologic recovery), and MDS (defined as hematological improvement).

Type: Interventional

Start Date: Mar 2018

open study

Cannabidivarin (CBDV) vs. Placebo in Children With Autism Spectrum Disorder (ASD)
Eric Hollander Autism Spectrum Disorder
This trial aims to study the efficacy and safety of cannabidivarin (CBDV) in children with ASD. expand

This trial aims to study the efficacy and safety of cannabidivarin (CBDV) in children with ASD.

Type: Interventional

Start Date: Apr 2019

open study

Tenofovir Alafenamide (TAF) in Children and Adolescents With Chronic Hepatitis B Virus Infection
Gilead Sciences Chronic Hepatitis B
The primary objective of Cohort 1 of this study is to evaluate the safety, tolerability, and antiviral activity (HBV DNA < 20 IU/mL) of tenofovir alafenamide (TAF) 25 mg once daily versus placebo through Week 24 in treatment-naive and treatment-experienced adolescents (aged 12... expand

The primary objective of Cohort 1 of this study is to evaluate the safety, tolerability, and antiviral activity (HBV DNA < 20 IU/mL) of tenofovir alafenamide (TAF) 25 mg once daily versus placebo through Week 24 in treatment-naive and treatment-experienced adolescents (aged 12 to < 18 years) with chronic hepatitis B (CHB). Cohort 2 will consist of 2 parts: Part A and Part B. Intensive pharmacokinetic (PK) data will be collected from all participants in Part A to confirm the dose of TAF in each dose group and the remaining participants will be enrolled into Part B once dose confirmation is achieved. The primary objectives of Part A are to evaluate the steady-state PK of TAF and tenofovir (TFV) and confirm the dose of TAF given once daily in children (aged 2 to < 12 years) with CHB. The primary objective of Part B is to evaluate the safety and tolerability of TAF at Week 48 and the antiviral activity (HBV DNA < 20 IU/mL) of TAF at Week 24 in children (aged 2 to < 12 years) with CHB.

Type: Interventional

Start Date: Nov 2016

open study

Study Evaluating Subjects With Distal Renal Tubular Acidosis
Advicenne Pharma Distal Renal Tubular Acidosis
This is a phase 3, prospective, multicenter, randomized, double-blinded, placebo-controlled, study product withdrawal study comparing the efficacy of ADV7103 versus placebo in preventing the development of metabolic acidosis defined by serum bicarbonate level in pediatric (6... expand

This is a phase 3, prospective, multicenter, randomized, double-blinded, placebo-controlled, study product withdrawal study comparing the efficacy of ADV7103 versus placebo in preventing the development of metabolic acidosis defined by serum bicarbonate level in pediatric (6 months to < 18 years of age) and adult (18 to 65 years of age) subjects with primary dRTA.

Type: Interventional

Start Date: Jan 2019

open study

An Early Feasibility Evaluation of the AccuCinch® Ventricular Repair System in Patients With Heart Failure...
Ancora Heart, Inc. Heart Failure Cardiomyopathy, Dilated
This is a non-randomized, prospective, multi-center Early Feasibility Study to evaluate the AccuCinch® Ventricular Repair System in Patients with Heart Failure and Reduced Ejection Fraction (HFrEF). expand

This is a non-randomized, prospective, multi-center Early Feasibility Study to evaluate the AccuCinch® Ventricular Repair System in Patients with Heart Failure and Reduced Ejection Fraction (HFrEF).

Type: Interventional

Start Date: Aug 2018

open study

Care Optimization Through Patient and Hospital Engagement Clinical Trial for Heart Failure
Duke University Heart Failure
CONNECT-HF is a large-scale, pragmatic, cluster-randomized clinical trial to evaluate the effect of a customized, multifaceted, health system-level quality-improvement (QI) program compared with usual care on heart failure (HF) outcomes and HF quality-of-care metrics. expand

CONNECT-HF is a large-scale, pragmatic, cluster-randomized clinical trial to evaluate the effect of a customized, multifaceted, health system-level quality-improvement (QI) program compared with usual care on heart failure (HF) outcomes and HF quality-of-care metrics.

Type: Interventional

Start Date: Apr 2017

open study

Phase III Study Evaluating Efficacy and Safety of Canakinumab in Combination With Docetaxel in Adult...
Novartis Pharmaceuticals Non-Small-Cell Lung
This phase III study is designed to evaluate the role of IL-1β inhibition in combination with docetaxel in subjects with advanced NSCLC previously treated with PD-(L)1 inhibitors and platinum-based chemotherapy. The randomized III part will be preceded by a safety run-in part... expand

This phase III study is designed to evaluate the role of IL-1β inhibition in combination with docetaxel in subjects with advanced NSCLC previously treated with PD-(L)1 inhibitors and platinum-based chemotherapy. The randomized III part will be preceded by a safety run-in part in which the recommended dose of the combination of canakinumab and docetaxel will be confirmed.

Type: Interventional

Start Date: Jan 2019

open study

Understanding the Pathophysiology of Migraine Pain
Montefiore Medical Center Migraine Disorders Migraine, Classic Migraine Without Aura
Migraine is the most common headache disorder, prevalent in 18% of females and 6% of males. Emergency room visits, physician consults, hospitalizations, medications, and indirect costs such as lost work days and decreased productivity place the global economic burden of migraines... expand

Migraine is the most common headache disorder, prevalent in 18% of females and 6% of males. Emergency room visits, physician consults, hospitalizations, medications, and indirect costs such as lost work days and decreased productivity place the global economic burden of migraines at over 20 billion dollars. It is prevalent in 28 million people in the US alone. Symptoms include unilateral, throbbing, debilitating headache pain accompanied by nausea, vomiting, photophobia, and phonophobia. Upwards of 75% of migraine patients have reduced functionability, have lost time at work, and 1/3 of patients require bed rest to manage the symptoms. The health-related impact on quality of life was comparable with that experienced by patients with congestive heart failure, hypertension, or diabetes. While the burden of migraines on our society is clear, the pathophysiology of migraines remains largely unknown. The trigeminovascular system, including the external and internal carotid arteries and their associated sensory fibers which subserve the head have long been implicated in the pain and cutaneous allodynia experienced by migraine patients. Wolff in 1953, was the first to posit that migraine headache pain is the caused by dilation or circumferential expansion of the extracranial carotid artery. He demonstrated that migraineurs had twice the pulse amplitude in their external carotid arteries compared to control subjects and these changes were directly correlated to migraine symptoms. In a 2008 study, randomized migraineurs received nitroglycerin via peripheral IV or placebo for 20 minutes prior to obtaining magnetic resonance angiography (MRA). Nitroglycerin, a potent dilator of blood vessels, reliably induced migraine-like pain in up to 80% of patients, and transient dilation of vessels of up to nearly 40%, mostly in the extracranial vessels. Sumatriptan's efficacy in migraine relief provides further evidence for this theory, as it is a selective extracranial vessel constrictor which does not cross the blood brain barrier. The goal of this current work is to utilize the direct, real-time angiography, which provides a high resolution map of vasculature, and demonstrate changes in vessel flow in patients who have migraine headache attacks. This information may guide therapeutic interventions in the future in order to better treat these migraine patients.

Type: Interventional

Start Date: Jan 2017

open study

PROSpect: Prone and Oscillation Pediatric Clinical Trial
University of Pennsylvania Acute Respiratory Distress Syndrome in Children
Severe pediatric acute respiratory distress syndrome (PARDS) is a life-threatening and frequent problem experienced by thousands of children each year. Little evidence supports current supportive practices during their critical illness. The overall objective of this study is... expand

Severe pediatric acute respiratory distress syndrome (PARDS) is a life-threatening and frequent problem experienced by thousands of children each year. Little evidence supports current supportive practices during their critical illness. The overall objective of this study is to identify the best positional and/or ventilation practice that leads to improved patient outcomes in these critically ill children. We hypothesize that children with severe PARDS treated with either prone positioning or high-frequency oscillatory ventilation (HFOV) will demonstrate more days off the ventilator when compared to children treated with supine positioning or conventional mechanical ventilation (CMV).

Type: Interventional

Start Date: May 2019

open study

Study to Evaluate Performance of LifePort® Liver Transporter System, a Machine Perfusion System, for...
Organ Recovery Systems, Inc. Liver Transplantation
Comparison of hypothermic machine perfusion of livers to standard of care (static cold storage). expand

Comparison of hypothermic machine perfusion of livers to standard of care (static cold storage).

Type: Interventional

Start Date: Apr 2019

open study

A Multi-Center Study of Riociguat in Patients With Sickle Cell Diseases
Gregory J. Kato Sickle Cell Disease
The proposed study is a Phase 2 multi-center, randomized, double-blind, placebo-controlled, parallel groups study aimed to evaluate the safety, tolerability and the efficacy of riociguat compared with placebo in patients with sickle cell disease (SCD). expand

The proposed study is a Phase 2 multi-center, randomized, double-blind, placebo-controlled, parallel groups study aimed to evaluate the safety, tolerability and the efficacy of riociguat compared with placebo in patients with sickle cell disease (SCD).

Type: Interventional

Start Date: Apr 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