Clinical Trials in Raleigh North Carolina

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Ellijay, Georgia 30536
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Study to Assess Safety, Tolerability and Efficacy of Incremental Doses of MGB-BP-3 in Patients With CDAD
NCT03824795
Condition: Clostridium Difficile Infection
Intervention: Drug: MGB-BP-3
Sponsors: MGB Biopharma Limited; Syneos Health
Recruiting
Observational Study Evaluating the Safety of ADASUVE® in Agitation Associated With Schizophrenia or Bipolar I Disorder
NCT03513549
Condition: Agitation,Psychomotor
Intervention: Drug: Loxapine 10 MG
Sponsors: Galen Limited; Pharmaceutical Research Associates
Recruiting
Physical Activity in Men Newly Diagnosed With Prostate Cancer: A Feasibility Study
NCT03331458
Condition: Prostate Cancer
Intervention: Behavioral: exrecise intervention
Sponsor: Duke University
Recruiting
Tryton Post Approval Study (PAS) for the Tryton Side Branch Stent
NCT03318796
Condition: Coronary Artery Disease
Intervention: Device: Coronary Artery Stenting
Sponsor: Tryton Medical, Inc.
Recruiting
Optimizing Overactive Bladder Treatment
NCT03904407
Condition: Overactive Bladder
Interventions: Other: Lactobacillus Probiotic Capsule; Other: Matching Lactobacillus Probiotic Placebo Capsule
Sponsors: University of North Carolina, Chapel Hill; Society of Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction
Recruiting
Establishing the Safety and Efficacy of Reloxaliase in Patients With Enteric Hyperoxaluria
NCT03847090
Condition: Enteric Hyperoxaluria
Interventions: Drug: Reloxaliase; Drug: Placebo
Sponsor: Allena Pharmaceuticals
Recruiting
Abuse Liability of Reduced Nicotine Content Cigarettes in the Context of Concurrent E-Cigarette Use
NCT02870218
Conditions: Nicotine Addiction; Cigarette Smoking
Interventions: Drug: Smoking research cigarettes with e-cigarette; Drug: Nicotine discrimination thresholds
Sponsors: Rose Research Center, LLC; National Institutes of Health (NIH); Food and Drug Administration (FDA); National Institute on Drug Abuse (NIDA)
Recruiting
Disseminating NIH Evidence Based Sickle Cell Recommendations in North Carolina
NCT03253211
Condition: Sickle Cell Disease
Intervention:
Sponsors: Duke University; Agency for Healthcare Research and Quality (AHRQ)
Recruiting
A Clinical Trial to Confirm Safety & Effectiveness of the SYNERGY 4.50 mm and 5.00 mm Stent for Treatment of Atherosclerotic Lesion(s)
NCT03875651
Conditions: Atherosclerosis; Heart Diseases, Coronary; Coronary Artery Disease; Cardiovascular Diseases
Intervention: Device: SYNERGY 4.50 mm and 5.0 mm Coronary Stent System
Sponsor: Boston Scientific Corporation
Recruiting
Implementation Program to Improve CHG Bathing Compliance
NCT03898115
Condition: Central Line-associated Bloodstream Infection (CLABSI)
Intervention: Behavioral: CHG Education
Sponsor: Duke University
Recruiting
A Postmarketing Study of Plecanatide in Breast Milk of Lactating Women Treated With TRULANCE®
NCT03551873
Condition: Chronic Idiopathic Constipation
Intervention: Drug: Plecanatide
Sponsor: Bausch Health Americas, Inc.
Recruiting
Placebo Controlled, Multiple Ascending Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SAP-001 in Gout Patients
NCT04040816
Conditions: Gout; Hyperuricemia
Intervention: Drug: SAP-001
Sponsor: Shanton Pharma Co., Ltd.
Recruiting
A Registry for Hereditary Cancer Risk Assessment and Genetic Testing
NCT04015102
Condition: Prostate Cancer
Intervention:
Sponsors: Myriad Genetic Laboratories, Inc.; Carolina Urologic Research Center
Recruiting
Environmental Polymorphisms Registry
NCT00341237
Conditions: Diabetes; Heart Disease; Asthma
Intervention:
Sponsor: National Institute of Environmental Health Sciences (NIEHS)
Recruiting
Pharmacokinetics of Dabrafenib in Subjects With Renal Impairment
NCT02852239
Condition: Renal Impairment
Intervention: Drug: dabrafenib
Sponsor: Novartis Pharmaceuticals
Recruiting
Safety and Tolerability Study of K0706 in Subjects With Parkinson's Disease
NCT02970019
Condition: Parkinson Disease
Interventions: Drug: K0706; Drug: Placebo
Sponsor: Sun Pharma Advanced Research Company Limited
Recruiting
Breast Cancer WEight Loss Study (BWEL Study)
NCT02750826
Condition: Breast Carcinoma
Interventions: Other: Health Education Program; Other: Weight Loss Intervention
Sponsors: Alliance for Clinical Trials in Oncology; National Cancer Institute (NCI); Division of Cancer Control; NIH Biomarker, Imaging and Quality of Life Studies Funding Program (BIQSFP); Canadian Cancer Trials Group
Recruiting
Aspirin in Preventing Recurrence of Cancer in Patients With HER2 Negative Stage II-III Breast Cancer After Chemotherapy, Surgery, and/or Radiation Therapy
NCT02927249
Condition: Node Positive HER2 Negative Breast Cancer
Interventions: Other: Placebo; Drug: Aspirin
Sponsors: Alliance for Clinical Trials in Oncology; National Cancer Institute (NCI); United States Department of Defense; Bayer; Canadian Cancer Trials Group
Recruiting
Clinical Trial of Neoadjuvant Chemotherapy With Atezolizumab or Placebo in Patients With Triple-Negative Breast Cancer Followed After Surgery by Atezolizumab or Placebo
NCT03281954
Condition: Triple Negative Breast Cancer
Interventions: Drug: Placebo; Drug: Atezolizumab
Sponsors: NSABP Foundation Inc; Genentech, Inc.; Hoffmann-La Roche
Recruiting
Evaluation of Major Cardiovascular Events in Patients With, or at High Risk for, Cardiovascular Disease Who Are Statin Intolerant Treated With Bempedoic Acid (ETC-1002) or Placebo
NCT02993406
Conditions: Cardiovascular Diseases; Statin Adverse Reaction
Interventions: Drug: Bempedoic acid 180 mg tablet; Drug: Matching placebo tablet
Sponsors: Esperion Therapeutics; The Cleveland Clinic
Recruiting
Doxorubicin Hydrochloride and Cyclophosphamide Followed by Paclitaxel With or Without Carboplatin in Treating Patients With Triple-Negative Breast Cancer
NCT02488967
Conditions: Breast Adenocarcinoma; Estrogen Receptor Negative; HER2/Neu Negative; Progesterone Receptor Negative; Stage IB Breast Cancer; Stage IIA Breast Cancer; Stage IIB Breast Cancer; Stage IIIA Breast Cancer; Stage IIIC Breast Cancer; Triple-Negative Breast Carcinoma
Interventions: Drug: Carboplatin; Drug: Cyclophosphamide; Drug: Doxorubicin Hydrochloride; Other: Laboratory Biomarker Analysis; Drug: Paclitaxel
Sponsors: NRG Oncology; National Cancer Institute (NCI)
Recruiting
Standard of Care Therapy With or Without Stereotactic Radiosurgery and/or Surgery in Treating Patients With Limited Metastatic Breast Cancer
NCT02364557
Conditions: Dyspnea; Fatigue; Nausea and Vomiting; Pain; Stage IV Breast Cancer
Interventions: Radiation: Stereotactic Radiosurgery; Procedure: Therapeutic Conventional Surgery; Other: Laboratory Biomarker Analysis
Sponsors: NRG Oncology; National Cancer Institute (NCI)
Recruiting
Safety Follow-up Study in Subjects With Silicone Gel-filled Breast Implants as Compared Both to Saline-filled Breast Implants and to National Norms
NCT00443274
Condition: Breast Implant
Interventions: Other: NBIR Placeholder; Device: 410 Arm; Device: BIFs
Sponsor: Allergan
Recruiting
To Evaluate the Safety and Tolerability of Atogepant 10mg, 30 mg and 60 mg Once a Day for the Prevention of Migraine in Participants With Episodic Migraine
NCT03777059
Condition: Episodic Migraine
Interventions: Drug: Atogepant 30 mg; Drug: Atogepant 60 mg; Drug: Placebo; Drug: Atogepant 10 mg
Sponsor: Allergan
Recruiting
A Study To Assess Pharmacodynamics, Safety And Tolerability Of PF-05221304 And PF-06865571 Co-Administered For 6 Weeks In Adults With Non-Alcoholic Fatty Liver Disease.
NCT03776175
Condition: Non-Alcoholic Fatty Liver Disease (NAFLD)
Interventions: Drug: PF-05221304 Monotherapy; Drug: PF-06865571 Monotherapy; Drug: Placebo; Drug: PF-05221304 and PF-06865571 Combination
Sponsor: Pfizer
Recruiting
A Trial of IW-3718 for 8 Weeks in Patients With Persistent Gastroesophageal Reflux Disease (GERD) Receiving Proton Pump Inhibitors
NCT03561090
Condition: Gastroesophageal Reflux Disease (GERD)
Interventions: Drug: IW-3718; Drug: placebo
Sponsor: Ironwood Pharmaceuticals, Inc.
Recruiting
The DES BTK Vascular Stent System vs PTA in Subjects With Critical Limb Ischemia
NCT03551496
Condition: Critical Limb Ischemia
Interventions: Combination Product: Drug Eluting Stent - Below the Knee; Device: Standard PTA Control Arm
Sponsor: Boston Scientific Corporation
Recruiting
Hemodynamic-GUIDEd Management of Heart Failure
NCT03387813
Conditions: Heart Failure; Heart Failure, Systolic; Heart Failure, Diastolic; Heart Failure NYHA Class II; Heart Failure NYHA Class III; Heart Failure NYHA Class IV; Heart Failure，Congestive; Heart Failure With Reduced Ejection Fraction; Heart Failure With Normal Ejection Fraction; Heart Failure; With Decompensation
Intervention: Device: CardioMEMS™ HF System
Sponsor: Abbott Medical Devices
Recruiting
Randomized Placebo-controlled Trial of FCM as Treatment for Heart Failure With Iron Deficiency
NCT03037931
Conditions: Heart Failure; Iron-deficiency
Interventions: Drug: Ferric carboxymaltose; Drug: Placebos
Sponsors: American Regent, Inc.; Duke Clinical Research Institute
Recruiting
Shockwave Medical Peripheral Lithoplasty System Study for PAD (Disrupt PAD III)
NCT02923193
Condition: Peripheral Arterial Disease
Interventions: Device: Shockwave Lithoplasty® Peripheral Lithoplasty System; Drug: Medtronic IN.PACT (DCB)
Sponsor: Shockwave Medical, Inc.
Recruiting
Safety and Efficacy Study of JNJ-64304500 in Participants With Moderately to Severely Active Crohn's Disease
NCT02877134
Condition: Crohn Disease
Interventions: Drug: JNJ-64304500; Drug: Placebo; Drug: Ustekinumab
Sponsor: Janssen Research & Development, LLC
Recruiting
Study to Assess the Efficacy and Safety of Ublituximab + TGR-1202 With or Without Bendamustine and TGR-1202 Alone in Patients With Previously Treated Non-Hodgkins Lymphoma
NCT02793583
Conditions: Diffuse Large B-Cell Lymphoma; Follicular Lymphoma; Marginal Zone Lymphoma; Mantle Cell Lymphoma
Interventions: Drug: TGR-1202 + Ublituximab; Drug: TGR-1202; Drug: TGR-1202 + Ublituximab + Bendamustine
Sponsor: TG Therapeutics, Inc.
Recruiting
Randomized On-X Anticoagulation Trial
NCT00291525
Condition: Heart Valve Disease
Interventions: Device: On-X valve using reduced anticoagulation; Device: On-X Valve with Standard warfarin Therapy
Sponsors: On-X Life Technologies, Inc.; Clinipace Worldwide; Alere, Inc.
Recruiting
Long-term Study to Evaluate and Clinical Outcomes in Patients With Favorable Intermediate Risk Localized Prostate Cancer
NCT03290508
Condition: Prostate Cancer
Intervention: Diagnostic Test: Prolaris Testing
Sponsor: Myriad Genetic Laboratories, Inc.
Recruiting
Evaluation of Transcatheter Aortic Valve Replacement Compared to SurveilLance for Patients With AsYmptomatic Severe Aortic Stenosis
NCT03042104
Conditions: Aortic Stenosis; Heart Diseases
Intervention: Device: Edwards SAPIEN 3 THV
Sponsor: Edwards Lifesciences
Recruiting
Transvenous Lead Removal Post-Market Clinical Study
NCT03688412
Condition: Cardiac Electrophysiology
Intervention: Device: Cook lead extraction devices
Sponsor: Cook Research Incorporated
Recruiting
Rucaparib in Treating Patients With Genomic LOH High and/or Deleterious BRCA1/2 Mutation Stage IV or Recurrent Non-small Cell Lung Cancer (A Lung-MAP Treatment Trial)
NCT03845296
Conditions: Deleterious BRCA1 Gene Mutation; Deleterious BRCA2 Gene Mutation; Loss of Heterozygosity; Lung Non-Small Cell Squamous Carcinoma; Recurrent Large Cell Lung Carcinoma; Recurrent Lung Adenocarcinoma; Recurrent Lung Non-Small Cell Carcinoma; Recurrent Non-Squamous Non-Small Cell Lung Carcinoma; Stage IV Lung Cancer AJCC v8; Stage IVA Lung Cancer AJCC v8; Stage IVB Lung Cancer AJCC v8
Intervention: Drug: Rucaparib
Sponsors: Southwest Oncology Group; National Cancer Institute (NCI)
Recruiting
A Single Ascending Dose Study in Adults (Stage 1) and Single Ascending Dose-Finding Study (Stage 2) in Elderly Subjects With ASP3772, A Pneumococcal Vaccine
NCT03803202
Conditions: Healthy Volunteers; Pneumococcal Disease
Interventions: Biological: ASP3772; Biological: PCV13; Biological: PPSV23
Sponsors: Astellas Pharma Global Development, Inc.; Affinivax
Recruiting
Study Comparing the Safety and Efficacy of IDP-120 Gel and IDP-120 Vehicle Gel in the Treatment of Acne Vulgaris
NCT03664752
Condition: Acne Vulgaris
Interventions: Drug: IDP-120 Gel; Drug: IDP-120 Vehicle Gel
Sponsor: Bausch Health Americas, Inc.
Recruiting
Comparative Effectiveness Study Telerehab Versus Conventional
NCT03468868
Condition: Multiple Sclerosis
Intervention: Behavioral: Exercise program for people with MS
Sponsors: Shepherd Center, Atlanta GA; University of Alabama at Birmingham; University of North Carolina, Chapel Hill; University of Georgia; The Cleveland Clinic; University of Colorado, Denver; Marquette University; Accelerated Cure Project for Multiple Sclerosis; Patient-Centered Outcomes Research Institute
Recruiting
MT10109L in the Treatment of Glabellar Lines
NCT03795922
Condition: Glabellar Lines
Interventions: Drug: MT10109L; Drug: Placebo
Sponsor: Allergan
Recruiting
MT10109L in the Treatment of Lateral Canthal Lines With or Without Concurrent Treatment of Glabellar Lines
NCT03732833
Condition: Lateral Canthal Lines, Glabellar Lines
Interventions: Drug: MT10109L; Drug: Placebo
Sponsor: Allergan
Recruiting
Extension of Phase 3 Gene Therapy for Painful Diabetic Neuropathy
NCT04055090
Conditions: Painful Diabetic Neuropathy; Diabetic Neuropathy, Painful
Interventions: Genetic: Long-Term Follow-Up of Patients who Received VM202; Drug: Long-Term Follow-Up of Patients who Received Placebo
Sponsor: Helixmith Co., Ltd.
Recruiting
Evaluating the Safety and Efficacy of Tradipitant vs. Placebo in Idiopathic and Diabetic Gastroparesis
NCT04028492
Conditions: Idiopathic Gastroparesis; Diabetic Gastroparesis; Gastroparesis
Interventions: Drug: Tradipitant; Drug: Placebo
Sponsor: Vanda Pharmaceuticals
Recruiting
Study of Azeliragon in Patients With Mild Alzheimer's Disease and Impaired Glucose Tolerance
NCT03980730
Condition: Alzheimer Disease
Interventions: Drug: Azeliragon; Drug: Placebo
Sponsor: vTv Therapeutics
Recruiting
A Study of MD-7246 to Treat Abdominal Pain in Patients With Diarrhea-predominant Irritable Bowel Syndrome
NCT03931785
Condition: Irritable Bowel Syndrome With Diarrhea (IBS-D)
Interventions: Drug: MD-7246; Drug: Placebo
Sponsors: Ironwood Pharmaceuticals, Inc.; Allergan Sales, LLC
Recruiting
Sodium Oxybate for Treatment of Excessive Daytime Sleepiness and Cataplexy in Narcolepsy
NCT02720744
Conditions: Excessive Daytime Sleepiness; Cataplexy; Narcolepsy
Interventions: Drug: Sodium Oxybate; Drug: Placebo
Sponsor: Flamel Ireland Limited
Recruiting
Clostridium Difficile Vaccine 2-Dose Versus 3-Dose Study
NCT03918629
Condition: Clostridium Difficile Associated Disease
Interventions: Biological: Clostridium difficile; Biological: Placebo
Sponsor: Pfizer
Recruiting
Study to Evaluate the Efficacy, Safety and Tolerability of Vibegron in Men With Overactive Bladder (OAB) Symptoms on Pharmacological Therapy for Benign Prostatic Hyperplasia (BPH)
NCT03902080
Condition: Overactive Bladder
Interventions: Drug: Vibegron; Drug: Placebo
Sponsor: Urovant Sciences GmbH
Recruiting
A Study of Baricitinib (LY3009104) in Adults With Severe or Very Severe Alopecia Areata
NCT03899259
Condition: Alopecia Areata
Interventions: Drug: Baricitinib; Drug: Placebo
Sponsors: Eli Lilly and Company; Incyte Corporation
Recruiting
Acute Treatment Trial in Adult Subjects With Migraines
NCT03872453
Condition: Migraine
Interventions: Drug: BHV3500 10mg; Drug: BHV3500 20mg; Drug: BHV3500 5mg; Drug: BHV3500 matching placebo; Device: Intranasal Aptar Pharma Unit Dose System
Sponsor: Biohaven Pharmaceuticals, Inc.
Recruiting
Efficacy, Safety, and Tolerability of Atogepant for the Prevention of Chronic Migraine
NCT03855137
Condition: Chronic Migraine
Interventions: Drug: Atogepant 30 mg; Drug: Atogepant 60 mg; Drug: Placebo
Sponsor: Allergan
Recruiting
Lung-MAP: A Master Screening Protocol for Previously-Treated Non-Small Cell Lung Cancer
NCT03851445
Condition: Previously Treated Non-Small Cell Lung Cancer
Intervention: Drug: Screening Platform
Sponsors: Southwest Oncology Group; National Cancer Institute (NCI)
Recruiting
Study of the Efficacy, Safety, and Tolerability of Serlopitant for the Treatment of Chronic Pruritus of Unknown Origin
NCT03841331
Condition: Pruritus
Interventions: Drug: 5 mg Serlopitant Tablets; Drug: Matching Placebo Tablets
Sponsor: Menlo Therapeutics Inc.
Recruiting
A Study to Evaluate the Safety and Tolerability of ABBV-951 in Subjects With Parkinson's Disease (PD)
NCT03781167
Condition: Parkinson's Disease (PD)
Intervention: Drug: ABBV-951
Sponsor: AbbVie
Recruiting
A Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics and Pharmacodynamics of M281 Administered to Adults With Generalized Myasthenia Gravis
NCT03772587
Condition: Generalized Myasthenia Gravis
Interventions: Drug: M281; Other: Placebo
Sponsor: Momenta Pharmaceuticals, Inc.
Recruiting
Study to Assess the Effect of Omecamtiv Mecarbil on Exercise Capacity in Subjects With Heart Failure
NCT03759392
Condition: Heart Failure With Reduced Ejection Fraction
Interventions: Drug: Omecamtiv Mecarbil; Drug: Placebo
Sponsors: Amgen; Cytokinetics; Servier
Recruiting
A Study to Assess Efficacy and Safety of SER‑287 in Adults With Active Mild-to-Moderate Ulcerative Colitis
NCT03759041
Condition: Ulcerative Colitis
Interventions: Drug: Vancomycin Pre-Treatment; Drug: Placebo for Vancomycin Pre-Treatment; Drug: SER-287; Drug: Placebo for SER-287
Sponsor: Seres Therapeutics, Inc.
Recruiting
A Study to Assess the Safety of GRF6021 Infusions in Subjects With Parkinson's Disease and Cognitive Impairment
NCT03713957
Condition: Parkinson Disease
Interventions: Drug: GRF6021; Other: Placebo
Sponsors: Alkahest, Inc.; Michael J. Fox Foundation for Parkinson's Research
Recruiting
Open- Label Trial of Sipuleucel-T Administered to Active Surveillance Patients for Newly Diagnosed Prostate Cancer
NCT03686683
Condition: Adenocarcinoma of the Prostate
Intervention: Biological: sipuleucel-T
Sponsors: Dendreon; PRA Health Sciences
Recruiting
Study to Assess the Long Term Safety and Tolerability of ACT-541468 in Adult and Elderly Subjects Suffering From Difficulties to Sleep
NCT03679884
Condition: Insomnia Disorder
Interventions: Drug: ACT-541468 10 mg; Drug: ACT-541468 25 mg; Drug: ACT-541468 50 mg; Drug: Placebo
Sponsor: Idorsia Pharmaceuticals Ltd.
Recruiting
PRECISION GRX Registry
NCT03278301
Condition: Coronary Artery Disease
Intervention: Device: Robotic-assisted PCI
Sponsor: Corindus Inc.
Recruiting
Single and Multiple Ascending Doses of MEDI6570 in Subjects With Type 2 Diabetes Mellitus
NCT03654313
Conditions: Atherosclerosis; Cardiovascular Disease
Interventions: Biological: MEDI6570; Biological: Placebo; Biological: Part B Placebo
Sponsor: MedImmune LLC
Recruiting
Long-term Safety, Tolerability and Effectiveness Study of Ofatumumab in Patients With Relapsing MS
NCT03650114
Condition: Relapsing Multiple Sclerosis
Intervention: Biological: Ofatumumab
Sponsor: Novartis Pharmaceuticals
Recruiting
A Study to Assess the Efficacy and Safety of Multiple Dose Levels of AZD7594 Administered Once Daily by Inhalation in Asthmatic Subjects
NCT03622112
Condition: Asthma
Interventions: Drug: AZD7594 DPI 55μg/50μg.; Drug: AZD7594 DPI 99 µg/90 µg; Drug: AZD7594 DPI 198 µg/180 µg; Drug: AZD7594 DPI 396 µg/360 µg once daily.; Drug: AZD7594 DPI 792 µg/720 µg; Drug: Placebo for AZD7594 once daily.; Drug: FF 100 µg once daily (open-label)
Sponsors: AstraZeneca; Parexel
Recruiting
REPRISE IV: LOTUS Edge Valve System in Intermediate Surgical Risk Subjects
NCT03618095
Condition: Aortic Valve Stenosis
Intervention: Device: LOTUS Edge Valve System
Sponsor: Boston Scientific Corporation
Recruiting
Safety and Efficacy of KPI-121 in Subjects With DED
NCT03616899
Condition: Kerato Conjunctivitis Sicca
Interventions: Drug: KPI-121 Ophthalmic Suspension; Drug: Vehicle
Sponsor: Kala Pharmaceuticals, Inc.
Recruiting
Long-term Extension Trial in Subjects With Atopic Dermatitis Who Participated in Previous Tralokinumab Trials - ECZTEND
NCT03587805
Condition: Atopic Dermatitis
Intervention: Drug: Tralokinumab
Sponsor: LEO Pharma
Recruiting
PSD502 in Subjects With Premature Ejaculation
NCT03578783
Condition: Premature Ejaculation
Interventions: Drug: Placebo; Drug: PSD502
Sponsor: Plethora Solutions Ltd
Recruiting
Study to Assess the Efficacy and Safety of ACT-541468 in Adult and Elderly Subjects Suffering From Difficulties to Sleep
NCT03575104
Condition: Insomnia Disorder
Interventions: Drug: ACT-541468; Other: Placebo
Sponsor: Idorsia Pharmaceuticals Ltd.
Recruiting
A Cariprazine Study in the Prevention of Relapse in Bipolar I Disorder Patients Whose Current Episode is Manic or Depressive, With or Without Mixed Features
NCT03573297
Conditions: Bipolar I Disorder; Mania; Depression
Interventions: Drug: Cariprazine; Drug: Placebo
Sponsor: Forest Laboratories
Recruiting
A Trial to Evaluate the Safety, Efficacy, and Tolerability of Brexpiprazole in Treating Agitation Associated With Dementia of the Alzheimer's Type
NCT03548584
Conditions: Agitaton Associated With Alzheimer's Dementia; Alzheimer Dementia
Interventions: Drug: Brexpiprazole; Other: Placebo
Sponsors: Otsuka Pharmaceutical Development & Commercialization, Inc.; H. Lundbeck A/S
Recruiting
A Study to Evaluate the Efficacy and Safety of TAK-906 in Adult Participants With Symptomatic Idiopathic or Diabetic Gastroparesis
NCT03544229
Conditions: Diabetic Gastroparesis; Idiopathic Gastroparesis
Interventions: Drug: TAK-906 Maleate; Drug: TAK-906 Maleate Placebo
Sponsor: Millennium Pharmaceuticals, Inc.
Recruiting
A Multicenter Study of the Efficacy and Safety of JZP-258 in the Treatment of Idiopathic Hypersomnia (IH) With an Open-label Safety Extension
NCT03533114
Condition: Idiopathic Hypersomnia
Interventions: Drug: JZP-258; Drug: Placebo Oral Solution
Sponsor: Jazz Pharmaceuticals
Recruiting
Effect of Sotagliflozin on Cardiovascular Events in Patients With Type 2 Diabetes Post Worsening Heart Failure (SOLOIST-WHF Trial)
NCT03521934
Condition: Heart Failure-Type 2 Diabetes Mellitus
Interventions: Drug: Sotagliflozin (SAR439954); Drug: Placebo
Sponsor: Sanofi
Recruiting
A Study of LY3303560 in Participants With Early Symptomatic Alzheimer's Disease
NCT03518073
Condition: Alzheimer Disease (AD)
Interventions: Drug: LY3303560; Drug: Placebo
Sponsor: Eli Lilly and Company
Recruiting
A Study to Evaluate the Effect of Testosterone Replacement Therapy (TRT) on the Incidence of Major Adverse Cardiovascular Events (MACE) and Efficacy Measures in Hypogonadal Men ( TRAVERSE )
NCT03518034
Conditions: Hypogonadism; Cardiovascular Diseases
Interventions: Drug: Testosterone; Drug: Placebo
Sponsors: AbbVie; Acerus Pharmaceuticals Corporation; Allergan Sales, LLC; Endo Pharmaceuticals; Upsher-Smith Laboratories
Recruiting
ECG Belt for CRT Response
NCT03504020
Condition: Heart Failure
Intervention: Device: ECG Belt Research System
Sponsor: Medtronic Cardiac Rhythm and Heart Failure
Recruiting
To Assess the Patients' Ability to Self-Administer Fasinumab
NCT03491904
Conditions: Osteoarthritis, Knee; Osteoarthritis, Hip
Interventions: Drug: Fasinumab AI; Drug: Fasinumab PFS
Sponsors: Regeneron Pharmaceuticals; Teva Pharmaceutical Industries, Ltd.
Recruiting
FLExAbility Sensor Enabled Substrate Targeted Ablation for the Reduction of VT Study
NCT03490201
Condition: Ventricular Tachycardia
Interventions: Device: Market Approved RF Ablation System; Device: FlexAbility SE Ablation Catheter
Sponsor: Abbott Medical Devices
Recruiting
Benefits of µCor in Ambulatory Decompensated Heart Failure
NCT03476187
Condition: Heart Failure
Intervention: Device: µCor
Sponsor: Zoll Medical Corporation
Recruiting
Study to Investigate CSL112 in Subjects With Acute Coronary Syndrome
NCT03473223
Condition: Acute Coronary Syndrome
Interventions: Biological: Apolipoprotein A-I [human] (apoA-I); Other: Placebo
Sponsor: CSL Behring
Recruiting
Study To Evaluate the Efficacy, Safety and Tolerability of E2027 in Participants With Dementia With Lewy Bodies
NCT03467152
Condition: Dementia With Lewy Bodies
Interventions: Drug: E2027; Drug: Placebo
Sponsor: Eisai Inc.
Recruiting
Safety and Efficacy of Adalimumab Versus Ustekinumab for One Year
NCT03464136
Condition: Crohn Disease
Interventions: Biological: Placebo for Ustekinumab; Biological: Placebo for Adalimumab; Biological: Ustekinumab (6 mg/kg); Biological: Ustekinumab (90 mg); Biological: Adalimumab (40 mg)
Sponsor: Janssen Scientific Affairs, LLC
Recruiting
Evaluate ALLN-177 in Patients With Enteric Hyperoxaluria
NCT03456830
Condition: Enteric Hyperoxaluria
Interventions: Drug: ALLN-177; Drug: Placebo
Sponsor: Allena Pharmaceuticals
Recruiting
Efficacy and Safety Study of Gantenerumab in Participants With Early Alzheimer's Disease (AD)
NCT03444870
Condition: Alzheimer Disease
Interventions: Drug: Gantenerumab; Drug: Placebo
Sponsor: Hoffmann-La Roche
Recruiting
Safety and Efficacy Study of Gantenerumab in Participants With Early Alzheimer's Disease (AD)
NCT03443973
Condition: Alzheimer's Disease
Interventions: Drug: Gantenerumab; Drug: Placebo
Sponsor: Hoffmann-La Roche
Recruiting
An Extension Study of GDC-0853 in Participants With Moderate to Severe Active Systemic Lupus Erythematosus
NCT03407482
Condition: Lupus Erythematosus, Systemic
Intervention: Drug: GDC-0853
Sponsor: Genentech, Inc.
Recruiting
Oral Sulopenem-etzadroxil/Probenecid Versus Ciprofloxacin for Uncomplicated Urinary Tract Infection in Adult Women
NCT03354598
Condition: Uncomplicated Urinary Tract Infections
Interventions: Drug: Sulopenem-Etzadroxil/Probenecid; Drug: Ciprofloxacin
Sponsor: Iterum Therapeutics, International Limited
Recruiting
A Study of the Efficacy and Safety of Upadacitnib (ABT-494) in Subjects With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Conventional and/or Biologic Therapies
NCT03345849
Condition: Crohn's Disease
Interventions: Drug: Upadacitinib; Drug: Placebo for Upadacitinib
Sponsor: AbbVie
Recruiting
A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Biologic Therapy
NCT03345836
Condition: Crohn's Disease
Interventions: Other: Matching placebo for upadacitinib; Drug: upadacitinib
Sponsor: AbbVie
Recruiting
Safety and Tolerability Study Of PF-06835375 In Subjects With Seropositive Systemic Lupus Erythematosus Or Rheumatoid Arthritis
NCT03334851
Conditions: Systemic Lupus Erythematosus; Rheumatoid Arthritis
Interventions: Drug: PF-06835375; Drug: Placebo
Sponsor: Pfizer
Recruiting
BOTOX® Intravesical Instillation in Participants With Overactive Bladder and Urinary Incontinence
NCT03320850
Conditions: Urinary Incontinence; Overactive Bladder With Urinary Incontinence
Interventions: Drug: OnabotulinumtoxinA and Hydrogel admixture; Drug: Placebo and Hydrogel admixture
Sponsor: Allergan
Recruiting
Strategic Management to Improve CRT Using Multi-Site Pacing Post Approval Study (Reference # C1918)
NCT03257436
Condition: Left Ventricular Dysfunction
Intervention: Device: CRT-D
Sponsors: Boston Scientific Corporation; ICON Clinical Research
Recruiting
An Investigational Study to Evaluate BMS-986165 in Patients With Systemic Lupus Erythematosus
NCT03252587
Condition: Systemic Lupus Erythematosus
Interventions: Drug: BMS-986165; Other: Placebo
Sponsor: Bristol-Myers Squibb
Recruiting
Electronic Patient Reporting of Symptoms During Cancer Treatment
NCT03249090
Conditions: Advanced Cancer; Metastatic Cancer
Interventions: Other: Patient Self-Reporting of Symptoms; Other: Usual Care Delivery
Sponsors: Alliance Foundation Trials, LLC.; Patient-Centered Outcomes Research Institute; University of North Carolina; Mayo Clinic; American Society of Clinical Oncology; American Cancer Society, Inc.; Dana-Farber Cancer Institute
Recruiting
Pembrolizumab in Treating Patients With Locally Advanced Bladder Cancer
NCT03244384
Conditions: Stage II Bladder Urothelial Carcinoma AJCC v6 and v7; Stage III Bladder Urothelial Carcinoma AJCC v6 and v7
Interventions: Other: Clinical Observation; Other: Laboratory Biomarker Analysis; Biological: Pembrolizumab; Other: Pharmacological Study; Other: Quality-of-Life Assessment; Other: Questionnaire Administration
Sponsor: National Cancer Institute (NCI)
Recruiting
Safety and Efficacy of the SurVeil™ Drug-Coated Balloon
NCT03241459
Conditions: Peripheral Arterial Disease; Peripheral Vascular Disease; Artery Disease, Peripheral; Femoropopliteal Artery Occlusion
Interventions: Device: Surmodics SurVeil DCB; Device: Medtronic IN.PACT Admiral DCB
Sponsor: SurModics, Inc.
Recruiting
ECOSPOR III - SER-109 Versus Placebo in the Treatment of Adults With Recurrent Clostridium Difficile Infection
NCT03183128
Condition: Clostridium Difficile Infection
Interventions: Drug: SER-109; Drug: Placebo
Sponsor: Seres Therapeutics, Inc.
Recruiting
Stellarex DCB Versus Standard Balloon Angioplasty for Treatment of Below-The-Knee (BTK) Arteries
NCT03175744
Condition: Critical Limb Ischemia
Interventions: Device: Stellarex DCB; Device: PTA Catheter
Sponsor: Spectranetics Corporation
Recruiting
A Study of Nivolumab Plus Brentuximab Vedotin Versus Brentuximab Vedotin Alone in Patients With Advanced Stage Classical Hodgkin Lymphoma, Who Are Relapsed/ Refractory or Who Are Not Eligible for Autologous Stem Cell Transplant,
NCT03138499
Condition: Hodgkin's Disease
Interventions: Biological: Nivolumab; Biological: Brentuximab vedotin
Sponsors: Bristol-Myers Squibb; Seattle Genetics, Inc.; Ono Pharmaceutical Co. Ltd
Recruiting
Study to Assess Outcomes in Women Undergoing Either Hysteroscopic Sterilization (Essure®) or Laparoscopic Tubal Sterilization
NCT03127722
Condition: Contraception
Interventions: Procedure: Blood draw; Device: ESSURE (BAY1454032); Procedure: Laparoscopic tubal sterilization
Sponsor: Bayer
Recruiting
Evaluation of Treatment Strategies for Severe CaLcIfic Coronary Arteries: Orbital Atherectomy vs. Conventional Angioplasty Technique Prior to Implantation of Drug-Eluting StEnts: The ECLIPSE Trial
NCT03108456
Conditions: Coronary Artery Disease; Ischemic Heart Disease; Non ST Segment Elevation Myocardial Infarction
Interventions: Device: Orbital Atherectomy; Device: Balloon
Sponsors: Cardiovascular Systems Inc; Cardiovascular Research Foundation, New York
Recruiting
A Study of the Efficacy and Safety of Risankizumab in Subjects With Crohn's Disease Who Responded to Induction Treatment in M16-006 or M15-991; or Completed M15-989
NCT03105102
Condition: Crohn's Disease
Interventions: Drug: placebo for risankizumab SC; Drug: risankizumab IV; Drug: placebo for risankizumab IV; Drug: risankizumab SC
Sponsor: AbbVie
Recruiting
Efficacy and Safety of Filgotinib in the Treatment of Perianal Fistulizing Crohn's Disease
NCT03077412
Condition: Fistulizing Crohn's Disease
Interventions: Drug: Filgotinib; Drug: Placebo to match filgotinib
Sponsors: Gilead Sciences; Galapagos NV
Recruiting
MILD® Percutaneous Image-Guided Lumbar Decompression: A Medicare Claims Study
NCT03072927
Condition: Lumbar Spinal Stenosis
Intervention: Device: MILD
Sponsor: Vertos Medical, Inc.
Recruiting
Efficacy and Safety of OBE2109 in Subjects With Heavy Menstrual Bleeding Associated With Uterine Fibroids
NCT03070899
Conditions: Uterine Fibroids; Heavy Menstrual Bleeding
Interventions: Drug: Placebo + Placebo Add-back; Drug: OBE2109 + Placebo Add-back; Drug: OBE2109 + Add-back
Sponsor: ObsEva SA
Recruiting
Profiling Biospecimens From Cancer Patients to Screen for Molecular Alterations Related to Treatment Selection
NCT03061305
Conditions: Cancer; Adult Solid Tumor; Lymphoma
Intervention:
Sponsor: Strata Oncology
Recruiting
Efficacy and Safety of Filgotinib in the Treatment of Small Bowel Crohn's Disease (SBCD)
NCT03046056
Condition: Small Bowel Crohn's Disease
Interventions: Drug: Filgotinib; Drug: Placebo to match filgotinib
Sponsors: Gilead Sciences; Galapagos NV
Recruiting
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Subcutaneous Infusions of ABBV-951 in Subjects With Parkinson's Disease
NCT03033498
Condition: Parkinson's Disease (PD)
Intervention: Drug: ABBV-951
Sponsor: AbbVie
Recruiting
AURORA: Phase 3 Study for the Efficacy and Safety of CVC for the Treatment of Liver Fibrosis in Adults With NASH
NCT03028740
Condition: Nonalcoholic Steatohepatitis
Interventions: Drug: Cenicriviroc; Drug: Placebo
Sponsor: Tobira Therapeutics, Inc.
Recruiting
QUILT-3.032: A Multicenter Clinical Trial of Intravesical Bacillus Calmette-Guerin (BCG) in Combination With ALT-803 in Patients With BCG Unresponsive High Grade Non-Muscle Invasive Bladder Cancer
NCT03022825
Condition: Bladder Cancer
Interventions: Drug: ALT-803; Drug: BCG
Sponsor: Altor BioScience
Recruiting
Myocardial Ischemia and Transfusion
NCT02981407
Conditions: Myocardial Infarction; Anemia
Intervention: Biological: Red Blood Cell Transfusion
Sponsors: Rutgers, The State University of New Jersey; University of Pittsburgh; National Heart, Lung, and Blood Institute (NHLBI)
Recruiting
A Phase II Study of M2951 in Systemic Lupus Erythematosus (SLE)
NCT02975336
Condition: Systemic Lupus Erythematosus
Interventions: Drug: Placebo; Drug: M2951
Sponsors: EMD Serono Research & Development Institute, Inc.; Merck KGaA, Darmstadt, Germany
Recruiting
Comparison of Operative to Monitoring and Endocrine Therapy (COMET) Trial For Low Risk DCIS
NCT02926911
Conditions: DCIS; Ductal Carcinoma in Situ
Interventions: Other: Guideline Concordant Care; Other: Active Surveillance
Sponsors: Alliance Foundation Trials, LLC.; Patient-Centered Outcomes Research Institute; Duke University; Dana-Farber Cancer Institute; M.D. Anderson Cancer Center; New York University; Washington University School of Medicine
Recruiting
Veliparib, Pembrolizumab, and Combination Chemotherapy in Treating Patient With Locally Advanced Rectal Cancer
NCT02921256
Conditions: Rectal Adenocarcinoma; Stage II Rectal Cancer AJCC v7; Stage III Rectal Cancer AJCC v7
Interventions: Drug: Capecitabine; Drug: Fluorouracil; Radiation: Intensity-Modulated Radiation Therapy; Drug: Leucovorin Calcium; Drug: Oxaliplatin; Biological: Pembrolizumab; Drug: Veliparib
Sponsor: National Cancer Institute (NCI)
Recruiting
Filgotinib in the Induction and Maintenance of Remission in Adults With Moderately to Severely Active Crohn's Disease
NCT02914561
Condition: Crohn's Disease
Interventions: Drug: Filgotinib; Drug: Placebo to match filgotinib
Sponsors: Gilead Sciences; Galapagos NV
Recruiting
Anemia Studies in Chronic Kidney Disease: Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor Daprodustat-Non-Dialysis (ASCEND-ND)
NCT02876835
Condition: Anaemia
Interventions: Drug: Daprodustat; Drug: Darbepoetin alfa; Drug: Placebo; Drug: Iron Therapy
Sponsor: GlaxoSmithKline
Recruiting
RelayPro Thoracic Stent-Graft in Subjects With Thoracic Aortic Aneurysms and Penetrating Atherosclerotic Ulcers
NCT02818972
Condition: Aortic Aneurysm, Thoracic
Intervention: Device: RelayPro
Sponsor: Bolton Medical
Recruiting
Phase 3 Study to Evaluate the Efficacy and Safety of Elafibranor Versus Placebo in Patients With Nonalcoholic Steatohepatitis (NASH)
NCT02704403
Condition: Nonalcoholic Steatohepatitis (NASH) With Fibrosis
Interventions: Drug: Elafibranor; Drug: Placebo
Sponsor: Genfit
Recruiting
The PARTNER 3 - Trial - The Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis
NCT02675114
Condition: Aortic Stenosis
Interventions: Procedure: Surgical aortic valve replacement (SAVR); Device: Transcatheter Aortic Valve Replacement (TAVR)
Sponsor: Edwards Lifesciences
Recruiting
Entyvio (Vedolizumab) Long Term Safety Study
NCT02674308
Condition: Ulcerative Colitis and Crohn's Disease
Interventions: Drug: Vedolizumab; Other: Other Biologic Agents
Sponsor: Takeda
Recruiting
Baroreflex Activation Therapy for Heart Failure
NCT02627196
Condition: Heart Failure
Interventions: Device: BAROSTIM NEO® System; Drug: Medical Management
Sponsor: CVRx, Inc.
Recruiting
Nivolumab After Surgery and Chemotherapy in Treating Patients With Stage IB-IIIA Non-small Cell Lung Cancer (An ALCHEMIST Treatment Trial)
NCT02595944
Conditions: Stage IB Lung Non-Small Cell Carcinoma AJCC v7; Stage II Lung Non-Small Cell Cancer AJCC v7; Stage IIA Lung Non-Small Cell Carcinoma AJCC v7; Stage IIB Lung Non-Small Cell Carcinoma AJCC v7; Stage IIIA Lung Non-Small Cell Cancer AJCC v7
Intervention: Biological: Nivolumab
Sponsor: National Cancer Institute (NCI)
Recruiting
An Open-Label Phase 3 Study to Examine the Long-Term Safety, Tolerability and Efficacy of APL-130277 for the Acute Treatment of "OFF" Episodes in Patients With Parkinson's Disease
NCT02542696
Condition: Parkinson Disease
Intervention: Drug: APL-130277
Sponsor: Sunovion
Recruiting
Cediranib Maleate and Olaparib or Standard Chemotherapy in Treating Patients With Recurrent Platinum-Resistant or -Refractory Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
NCT02502266
Conditions: Deleterious BRCA1 Gene Mutation; Deleterious BRCA2 Gene Mutation; Fallopian Tube Clear Cell Adenocarcinoma; Fallopian Tube Endometrioid Adenocarcinoma; Fallopian Tube Serous Adenocarcinoma; Fallopian Tube Transitional Cell Carcinoma; Fallopian Tube Undifferentiated Carcinoma; Ovarian Clear Cell Adenocarcinoma; Ovarian Endometrioid Adenocarcinoma; Ovarian Seromucinous Carcinoma; Ovarian Serous Adenocarcinoma; Ovarian Transitional Cell Carcinoma; Ovarian Undifferentiated Carcinoma; Primary Peritoneal Serous Adenocarcinoma; Recurrent Fallopian Tube Carcinoma; Recurrent Ovarian Carcinoma; Recurrent Primary Peritoneal Carcinoma
Interventions: Drug: Cediranib; Drug: Cediranib Maleate; Other: Laboratory Biomarker Analysis; Drug: Olaparib; Drug: Paclitaxel; Drug: Pegylated Liposomal Doxorubicin Hydrochloride; Other: Questionnaire Administration; Drug: Topotecan; Drug: Topotecan Hydrochloride
Sponsors: National Cancer Institute (NCI); NRG Oncology
Recruiting
Assessment of the GORE® EXCLUDER® Conformable AAA Endoprosthesis in the Treatment of Abdominal Aortic Aneurysms
NCT02489539
Condition: Aortic Aneurysm, Abdominal
Intervention: Device: GORE® EXCLUDER® Conformable AAA Endoprosthesis
Sponsor: W.L.Gore & Associates
Recruiting
Lower-Limb Adventitial Infusion of DexaMethasone Via Bullfrog to Reduce Occurrence of Restenosis After Atherectomy (ATX)-Based Revascularization
NCT02479620
Condition: Chronic Limb Ischemia
Intervention: Drug: Dexamethasone Sodium Phosphate Injection, USP, 4 mg/mL
Sponsor: Mercator MedSystems, Inc.
Recruiting
Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial)
NCT02465060
Conditions: Advanced Malignant Solid Neoplasm; Bladder Carcinoma; Breast Carcinoma; Cervical Carcinoma; Colon Carcinoma; Colorectal Carcinoma; Endometrial Carcinoma; Esophageal Carcinoma; Gastric Carcinoma; Glioma; Head and Neck Carcinoma; Kidney Carcinoma; Liver and Intrahepatic Bile Duct Carcinoma; Lung Carcinoma; Lymphoma; Malignant Uterine Neoplasm; Melanoma; Ovarian Carcinoma; Pancreatic Carcinoma; Plasma Cell Myeloma; Prostate Carcinoma; Rectal Carcinoma; Recurrent Bladder Carcinoma; Recurrent Breast Carcinoma; Recurrent Cervical Carcinoma; Recurrent Colon Carcinoma; Recurrent Colorectal Carcinoma; Recurrent Esophageal Carcinoma; Recurrent Gastric Carcinoma; Recurrent Glioma; Recurrent Head and Neck Carcinoma; Recurrent Liver Carcinoma; Recurrent Lung Carcinoma; Recurrent Lymphoma; Recurrent Malignant Solid Neoplasm; Recurrent Melanoma; Recurrent Ovarian Carcinoma; Recurrent Pancreatic Carcinoma; Recurrent Plasma Cell Myeloma; Recurrent Prostate Carcinoma; Recurrent Rectal Carcinoma; Recurrent Skin Carcinoma; Recurrent Thyroid Gland Carcinoma; Recurrent Uterine Corpus Carcinoma; Refractory Lymphoma; Refractory Malignant Solid Neoplasm; Refractory Plasma Cell Myeloma; Skin Carcinoma; Thyroid Gland Carcinoma; Uterine Corpus Cancer
Interventions: Drug: Adavosertib; Drug: Afatinib; Drug: Afatinib Dimaleate; Drug: Binimetinib; Drug: Capivasertib; Drug: Copanlisib; Drug: Copanlisib Hydrochloride; Drug: Crizotinib; Other: Cytology Specimen Collection Procedure; Drug: Dabrafenib; Drug: Dabrafenib Mesylate; Drug: Dasatinib; Drug: Defactinib; Drug: Defactinib Hydrochloride; Drug: Erdafitinib; Drug: FGFR Inhibitor AZD4547; Drug: Ipatasertib; Other: Laboratory Biomarker Analysis; Drug: Larotrectinib; Drug: Larotrectinib Sulfate; Biological: Nivolumab; Drug: Osimertinib; Drug: Palbociclib; Biological: Pertuzumab; Drug: PI3K-beta Inhibitor GSK2636771; Drug: Sapanisertib; Drug: Sunitinib Malate; Drug: Taselisib; Drug: Trametinib; Biological: Trastuzumab; Biological: Trastuzumab Emtansine; Drug: Ulixertinib; Drug: Vismodegib
Sponsor: National Cancer Institute (NCI)
Recruiting
A Study in Patients With Acute Major Bleeding to Evaluate the Ability of Andexanet Alfa to Reverse the Anticoagulation Effect of Direct and Indirect Oral Anticoagulants (Extension Study)
NCT02329327
Condition: Bleeding
Intervention: Biological: Andexanet
Sponsors: Portola Pharmaceuticals; Population Health Research Institute
Recruiting
Crizotinib in Treating Patients With Stage IB-IIIA Non-small Cell Lung Cancer That Has Been Removed by Surgery and ALK Fusion Mutations (An ALCHEMIST Treatment Trial)
NCT02201992
Conditions: ALK Gene Rearrangement; ALK Gene Translocation; ALK Positive; Stage IB Non-Small Cell Lung Carcinoma AJCC v7; Stage II Non-Small Cell Lung Cancer AJCC v7; Stage IIA Non-Small Cell Lung Carcinoma AJCC v7; Stage IIB Non-Small Cell Lung Carcinoma AJCC v7; Stage IIIA Non-Small Cell Lung Cancer AJCC v7
Interventions: Other: Clinical Observation; Drug: Crizotinib; Other: Laboratory Biomarker Analysis
Sponsors: ECOG-ACRIN Cancer Research Group; National Cancer Institute (NCI)
Recruiting
Genetic Testing in Screening Patients With Stage IB-IIIA Non-Small Cell Lung Cancer That Has Been or Will Be Removed by Surgery (The ALCHEMIST Screening Trial)
NCT02194738
Conditions: Lung Adenocarcinoma; Lung Large Cell Carcinoma; Stage IB Lung Non-Small Cell Carcinoma AJCC v7; Stage IB Lung Squamous Cell Carcinoma AJCC v7; Stage II Lung Non-Small Cell Cancer AJCC v7; Stage II Lung Squamous Cell Carcinoma AJCC v7; Stage IIA Lung Non-Small Cell Carcinoma AJCC v7; Stage IIA Lung Squamous Cell Carcinoma AJCC v7; Stage IIB Lung Non-Small Cell Carcinoma AJCC v7; Stage IIB Lung Squamous Cell Carcinoma AJCC v7; Stage IIIA Lung Non-Small Cell Cancer AJCC v7; Stage IIIA Lung Squamous Cell Carcinoma AJCC v7
Interventions: Other: Clinical Observation; Drug: Crizotinib; Other: Cytology Specimen Collection Procedure; Drug: Erlotinib Hydrochloride; Biological: Nivolumab; Other: Placebo
Sponsor: National Cancer Institute (NCI)
Recruiting
Erlotinib Hydrochloride in Treating Patients With Stage IB-IIIA Non-small Cell Lung Cancer That Has Been Completely Removed by Surgery (An ALCHEMIST Treatment Trial)
NCT02193282
Conditions: ALK Gene Rearrangement; EGFR Exon 19 Deletion Mutation; EGFR NP_005219.2:p.L858R; Stage IB Lung Non-Small Cell Carcinoma AJCC v7; Stage II Lung Non-Small Cell Cancer AJCC v7; Stage IIA Lung Non-Small Cell Carcinoma AJCC v7; Stage IIB Lung Non-Small Cell Carcinoma AJCC v7; Stage IIIA Lung Non-Small Cell Cancer AJCC v7
Interventions: Other: Clinical Observation; Drug: Erlotinib Hydrochloride; Other: Laboratory Biomarker Analysis; Other: Placebo
Sponsor: National Cancer Institute (NCI)
Recruiting
Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial
NCT02089217
Condition: Carotid Stenosis
Interventions: Procedure: Carotid endarterectomy (CEA); Device: Carotid Stenting (CAS); Other: Intensive Medical Management - no CEA; Other: Intensive Medical Management - no CAS
Sponsors: Thomas G. Brott, M.D.; National Institute of Neurological Disorders and Stroke (NINDS)
Recruiting
Best Endovascular vs. Best Surgical Therapy in Patients With Critical Limb Ischemia
NCT02060630
Condition: Critical Limb Ischemia
Interventions: Procedure: Open surgical revascularization; Device: Endovascular revascularization
Sponsors: New England Research Institutes; Brigham and Women's Hospital; Massachusetts General Hospital; Boston Medical Center; National Heart, Lung, and Blood Institute (NHLBI)
Recruiting
Dimethyl Fumarate (DMF) Observational Study
NCT02047097
Condition: Multiple Sclerosis
Intervention: Drug: dimethyl fumarate
Sponsor: Biogen
Recruiting
Lenalidomide Plus Rituximab Followed by Lenalidomide Versus Rituximab Maintenance for Relapsed/Refractory Follicular, Marginal Zone or Mantle Cell Lymphoma.
NCT01996865
Condition: Lymphoma, Non-Hodgkin
Interventions: Drug: Lenalidomide; Drug: Rituximab
Sponsor: Celgene
Recruiting
Apixaban for the Reduction of Thrombo-Embolism in Patients With Device-Detected Sub-Clinical Atrial Fibrillation
NCT01938248
Conditions: Atrial Fibrillation; Stroke
Interventions: Drug: Apixaban; Drug: aspirin
Sponsors: Population Health Research Institute; Bristol-Myers Squibb; Pfizer; Medtronic; Canadian Institutes of Health Research (CIHR); Hamilton Health Sciences Foundation
Recruiting
Safety and Effectiveness of Belimumab in Systemic Lupus Erythematosus Registry
NCT01729455
Condition: Systemic Lupus Erythematosus
Interventions: Biological: BENLYSTA; Other: SLE treatment
Sponsors: Human Genome Sciences Inc., a GSK Company; GlaxoSmithKline
Recruiting
Radiation Therapy Regimens in Treating Patients With Limited-Stage Small Cell Lung Cancer Receiving Cisplatin and Etoposide
NCT00632853
Condition: Lung Cancer
Interventions: Radiation: Standard Radiation Dose Therapy; Drug: cisplatin; Drug: etoposide; Radiation: High Radiation Dose Therapy; Drug: carboplatin
Sponsors: Alliance for Clinical Trials in Oncology; National Cancer Institute (NCI)
Recruiting
Psoriasis Longitudinal Assessment and Registry (PSOLAR)
NCT00508547
Conditions: Psoriasis; Arthritis, Psoriatic
Interventions: Biological: Ustekinumab; Biological: Biological therapies other than infliximab, ustekinumab and guselkumab; Drug: Conventional systemic agents; Biological: Infliximab; Biological: Guselkumab
Sponsor: Janssen Scientific Affairs, LLC
Recruiting
Setmelanotide (RM-493), Melanocortin-4 Receptor (MC4R) Agonist, in Bardet-Biedl Syndrome (BBS) and Alström Syndrome (AS) Patients With Moderate to Severe Obesity
NCT03746522
Conditions: Bardet Biedl Syndrome (BBS); Alström Syndrome (AS)
Interventions: Drug: Setmelanotide; Drug: Placebos
Sponsor: Rhythm Pharmaceuticals, Inc.
Recruiting
A Study of Crisaborole Ointment 2%; Crisaborole Vehicle; TCS and TCI in Subjects Aged ≥ 2 Years, With Mild-moderate AD
NCT03539601
Condition: Atopic Dermatitis
Interventions: Drug: Crisaborole ointment, 2%; Drug: Hydrocortisone butyrate cream, 0.1%; Drug: Pimecrolimus cream, 1%; Drug: Crisaborole Vehicle
Sponsor: Pfizer
Recruiting
Safety, Tolerability, and Immunogenicity of V114 in Healthy Infants (V114-029)
NCT03893448
Conditions: Pneumococcal Infections; Pneumococcal Vaccines
Interventions: Biological: V114; Biological: Prevnar 13™; Biological: RotaTeq™; Biological: Pentacel™; Biological: RECOMBIVAX HB™; Biological: VAQTA™; Biological: M-M-R™; Biological: VARIVAX™; Biological: HIBERIX™
Sponsor: Merck Sharp & Dohme Corp.
Recruiting
TRuE AD1 - An Efficacy and Safety Study of Ruxolitinib Cream in Adolescents and Adults With Atopic Dermatitis
NCT03745638
Condition: Atopic Dermatitis
Interventions: Drug: Ruxolitinib cream; Drug: Vehicle cream
Sponsor: Incyte Corporation
Recruiting
Efficacy and Safety of Oral Ibrexafungerp (SCY-078) vs. Placebo in Subjects With Acute Vulvovaginal Candidiasis
NCT03734991
Condition: Candida Vulvovaginitis
Interventions: Drug: Ibrexafungerp; Drug: Placebo
Sponsor: Scynexis, Inc.
Recruiting
Study to Investigate Efficacy and Safety of PF-04965842 in Subjects Aged 12 Years and Over With Moderate to Severe Atopic Dermatitis With the Option of Rescue Treatment in Flaring Subjects
NCT03627767
Conditions: Dermatitis; Dermatitis, Atopic; Eczema; Skin Diseases; Skin Diseases, Genetic; Genetic Diseases, Inborn; Skin Diseases, Eczematous; Hypersensitivity; Hypersensitivity, Immediate; Immune System Diseases
Interventions: Drug: PF-04965842 100 mg; Drug: PF-04965842 200 mg; Drug: Placebo
Sponsor: Pfizer
Recruiting
Disrupt CAD III With the Shockwave Coronary IVL System
NCT03595176
Conditions: Coronary Artery Disease; Myocardial Infarction
Intervention: Device: Lithotripsy
Sponsor: Shockwave Medical, Inc.
Recruiting
A Study of Oral VT-1161 for the Treatment of Patients With Recurrent Vaginal Candidiasis (Yeast Infection)
NCT03562156
Condition: Recurrent Vulvovaginal Candidiasis
Interventions: Drug: VT-1161; Drug: Placebo
Sponsor: Mycovia Pharmaceuticals Inc.
Recruiting
Safety and Efficacy of TRx0237 in Subjects With Early Alzheimer's Disease
NCT03446001
Condition: Alzheimer Disease
Interventions: Drug: TRx0237 8 mg/day; Drug: Placebo; Drug: TRx0237 16 mg/day
Sponsor: TauRx Therapeutics Ltd
Recruiting
Study to Evaluate Efficacy and Safety of PF-04965842 With or Without Topical Medications in Subjects Aged 12 Years and Older With Moderate to Severe Atopic Dermatitis
NCT03422822
Condition: Dermatitis, Atopic
Interventions: Drug: PF-04965842 100 mg; Drug: PF-04965842 200 mg; Drug: Placebo
Sponsor: Pfizer
Recruiting
A Study of the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Crohn's Disease
NCT03105128
Condition: Crohn's Disease
Interventions: Drug: placebo for risankizumab; Drug: risankizumab IV; Drug: risankizumab SC
Sponsor: AbbVie
Recruiting
A Study to Assess the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment
NCT03104413
Condition: Crohn's Disease
Interventions: Drug: placebo for risankizumab IV; Drug: risankizumab SC; Drug: risankizumab IV
Sponsor: AbbVie
Recruiting
3T MRI CIED Post-Approval Study
NCT02969395
Condition: Cardiac Rhythm Disorder
Intervention:
Sponsor: Medtronic
Recruiting
Chronic Hypertension and Pregnancy (CHAP) Project
NCT02299414
Condition: Hypertension
Interventions: Drug: Anti-hypertensive therapy; Other: No anti-hypertensive therapy (unless BP is severe)
Sponsors: University of Alabama at Birmingham; Columbia University; Drexel University College of Medicine; Rutgers, The State University of New Jersey; Lehigh Valley Hospital; Saint Peters University Hospital; Christiana Care Health Services; Washington University School of Medicine; Duke University; University of Texas Southwestern Medical Center; The University of Texas Health Science Center, Houston; Stanford University; University of Pennsylvania; The University of Texas Medical Branch, Galveston; University of Utah; Intermountain Health Care, Inc.; University of California, San Francisco; Johns Hopkins University; University of Pittsburgh; Ochsner Health System; University of North Carolina, Chapel Hill; National Heart, Lung, and Blood Institute (NHLBI); WakeMed Health and Hospitals; San Francisco General Hospital; McKay-Dee Hospital; Winthrop University Hospital; New York Hospital Queens; Latter Day Saints Hospital; Lyndon B Johnson General Hospital; Virtua Medical Group; Bayview Medical Center; Duke Regional Hospital; Utah Valley Regional Medical Center; Northwestern; Brown (WIHRI); Baylor College of Medicine; Case Western/Metro Health; Ohio State University; University of Iowa; University of California, San Diego; Indiana University; Unity Point Health-Meriter Hospital WI; Weill Medical College of Cornell University; University of Oklahoma; Medical University of South Carolina; Beaumont Hospital; University of Colorado, Denver; University of Kansas Medical Center; Denver Health and Hospital Authority; Gundersen Health System; Aurora Health Care; Oregon Health and Science University; Medical College of Wisconsin; Temple University; New Jersey Medical School; University of South Alabama; Vanderbilt University; University of Arkansas; Miami Valley Hospital; Emory University; St. Luke's Hospital and Health Network, Pennsylvania; Cleveland Clinic Fairview Hospital; University of Tennessee Health Science Center; TriHealth Inc.; Cleveland Clinic Hillcrest Hospital; Tulane University; Yale University; Arrowhead Regional Medical Center
Recruiting
Safety and Efficacy Study of Lotus Valve for Transcatheter Aortic Valve Replacement
NCT02202434
Condition: Aortic Stenosis
Interventions: Device: Lotus Valve System; Device: CoreValve/Evolut R Transcatheter Aortic Valve Replacement System; Device: LOTUS Edge Valve System
Sponsor: Boston Scientific Corporation
Recruiting
Product Surveillance Registry
NCT01524276
Conditions: Cardiac Rhythm Disorders; Urological Disorders; Neurological Disorders; Cardiovascular Disorders; Digestive Disorders; Intracranial Aneurysm; Mechanical Circulatory Support
Intervention:
Sponsor: Medtronic
Recruiting
Safety Study in Patients With Multiple Sclerosis Treated Fingolimod or Other Approved Disease-modifying Therapies
NCT01442194
Condition: Multiple Sclerosis
Interventions: Drug: other disease-modifying therapy; Drug: Fingolimod
Sponsor: Novartis Pharmaceuticals
Recruiting

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