bioihbjkbjnl/mcl2 huggingface dataset:
Modeling Stress-precipitated Smoking Behavior for Medication Development
Condition: Smoking
Intervention: guanfacine; placebo
Intervention description: 3 mg/day, with 3-week lead-in medication period. The starting dose is 0.5 mg/day for days 1-3, followed by 1.5mg/day for days 4-7, followed by 2 mg/day for days 8-12, followed by 2.5 mg/day for days 13-15, followed by 3 mg/day from day 16 to remainder of study. 5-day taper at end of study.; placebo
Intervention MeSH terms: Guanfacine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: smoking lapse behavior; guanfacine

Summary:

      The purpose of this study is to examine whether guanfacine will attenuate the ability of
      stress to precipitate smoking lapse behavior in treatment seeking and non-treatment seeking
      daily smokers.
    

Eligibility criteria:

        Inclusion Criteria:

          -  ages 18-60

          -  able to read and write in English

          -  smokers

        Exclusion Criteria:

          -  any significant current medical conditions that would contraindicate smoking

          -  current Diagnostic and Statistical Manual IV (DSM-IV) abuse or dependence of other
             substances, other than nicotine (or caffeine) dependence

          -  positive test result at intake appointments on urine drug screens conducted for
             opiates, cocaine, or benzodiazepines

          -  women who are pregnant or nursing

          -  suicidal, homicidal or evidence of severe mental illness

          -  participants prescribed any psychotropic drug in the 30 days prior to study enrollment

          -  blood donation within the past 6 weeks

          -  participants who have engaged in a quit attempt in the past 3 months

          -  specific exclusions for administration of guanfacine not already specified include:
             Hypotensive individuals with sitting blood pressure below 90/50 mmHG; EKG evidence at
             baseline screening of any clinically significant conduction abnormalities, including a
             Bazett's corrected QT interval (QTc) >450 msec for men and QTc>470 msec for women;
             known intolerance for guanfacine
Robot-Assisted Hand Motor Therapy for Subjects With Hemiparetic Stroke
Condition: Stroke
MeSH terms: Stroke
Intervention: Hand & Wrist Assisting Robotic Device
Intervention description: Treatment occurs in 2 hour sessions, 4 times a week over 3 weeks. In each treatment session, you will sit in a chair and have your weak hand attached to a mechanical device (the robot), which will help you open and close your hand. During the treatment, different types of objects (with varying shapes, sizes, and weight) will be placed into your hand. You will be given a variety of instructions related to the grasping, feeling, or identifying of the object in your hand. Sometimes these instructions will be given from the investigator and sometimes from the computer. You will often be asked to grasp, or release, each of these objects as best you can. You will also be asked to concentrate on the object in your hand. An example of what you may be asked to do is to name the object. During other times, you will play games, using the robot to control game parts on the computer screen. At other times, you will move your hand so that the robot can measure your hand function.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 41.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: stroke; rehabilitation

Summary:

      The purpose of this study is to develop and assess the effectiveness of robot-assisted
      movement therapy in enhancing hand motor function in subjects with chronic hemiparetic
      stroke, and to identify predictors of treatment response.
    

Eligibility criteria:

        Inclusion Criteria:

          1. At least 18 years old

          2. Had stroke between 11-26 weeks ago

          3. Have some weakness in one of your wrists or hands due to stroke

          4. Did not have too much disability prior to stroke

          5. Do not have major depression

        Exclusion Criteria:

          1. Non-English speaking

          2. If you have trouble keeping good attention

          3. Pregnant, advanced liver, kidney, heart, or lung disease

          4. Terminal medical diagnosis or major neurological or psychiatric disease apart from
             stroke

          5. Cannot undergo MRI scanning

          6. Have history of brain surgery or seizures
Evaluate the Safety and Efficacy of 48-Hour Infusions of HNO (Nitroxyl) Donor in Hospitalized Patients With Heart Failure
Condition: Heart Failure
MeSH terms: Heart Failure
Intervention: HNO Donor; Placebo
Intervention description: Infusion; Infusion
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 329.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      A Study to Evaluate Safety and Efficacy of Continuous 48-Hour Intravenous Infusions of HNO
      Donor in Hospitalized Patients with Heart Failure and Impaired Systolic Function
    

Eligibility criteria:

        For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
        visit www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Actively being hospitalized for acute decompensated heart failure

          -  At least 1 administration of IV diuretic for the current episode

          -  Be randomized within 18 hours of first dose of IV diuretic for current episode for
             Part 1 Cohort 1, or 48 hours for first dose for Part II Cohort II

          -  Have shortness of breath at rest or with minimal exertion after administration of 1
             dose of IV diuretic

          -  Have history of heart failure and a left ventricular ejection fraction (LVEF) ≤ 40%

        Exclusion Criteria:

          -  Systolic blood pressure <105mm Hg or >160mm Hg or heart rate <50 or >130 bpm

          -  Have an active infection requiring IV anti-microbial treatment

          -  Be hospitalized with acute coronary syndrome, coronary revascularization or acute
             myocardial infarction during the previous 90 days prior to screening

          -  Have a history of a cerebral vascular accident (CVA or stroke) or of a transient
             ischemic attack (TIA) during the previous 90 days prior to screening

          -  Suspected acute lung disease (e.g pneumonia or asthma) or severe chronic lung disease
             (e.g. severe chronic obstructive pulmonary disease, or pulmonary fibrosis)

        Other protocol defined inclusion/exclusion criteria could apply
A Study of Telaprevir (VX-950), Pegasys and Copegus in Hepatitis C (PROVE3)
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Intervention: Telaprevir; Ribavirin; Pegylated Interferon Alfa 2a; Matching Placebo
Intervention description: tablet; tablet; Solution for injection; Tablet
Intervention MeSH terms: Interferons; Ribavirin; Interferon-alpha; Interferon alpha-2; Peginterferon alfa-2a
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 465.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Genotype 1

Summary:

      The PROVE3 trial is a partially double blinded, randomized, Phase 2 research study of an
      investigational drug, Telaprevir (VX-950) or Placebo, with Pegylated Interferon Alfa 2a
      (Peg-IFN-alfa-2a, Pegasys®), and Ribavirin (RBV, Copegus®) in people with genotype 1
      hepatitis C who have not achieved a Sustained Viral Response (SVR) with a previous treatment
      of interferon therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and females between 18 and 70 years old

          -  Detectable plasma hepatitis C virus (HCV) ribonucleic acid (RNA) greater than or equal
             to (>=) 10,000 international units per milliliter (IU/mL)

          -  Must have chronic hepatitis C (genotype 1) and have already received at least one
             prior course of pegylated interferon alfa 2a with ribavirin

          -  Cannot also be infected with Human Immunodeficiency Virus or hepatitis B

          -  Must be judged to be in general good health and able to receive Pegasys® and Copegus®

          -  No drug or alcohol abuse in the last year

          -  Must agree to use two effective methods of birth control during the study and for 6
             months after you stop taking study medication. One of the methods needs to be a
             'barrier' method (condom or diaphragm)

          -  If you are a woman, you cannot be in this study if you are pregnant or nursing

        Exclusion Criteria:

          -  Participation in any clinical trial of a HCV protease inhibitor of any duration

          -  Prior response to therapy and failure to achieve SVR which was due to treatment
             non-compliance

          -  Any other cause of significant liver disease in addition to hepatitis C; this may
             include but is not limited to, hepatitis B, drug or alcohol-related cirrhosis,
             autoimmune hepatitis, hemochromatosis, Wilson's disease, nonalcoholic steatohepatitis,
             or primary biliary cirrhosis

          -  Diagnosed or suspected hepatocellular carcinoma

          -  History of or current evidence of decompensated liver disease

          -  Participation in any clinical trial of an investigational drug within 90 days before
             drug administration or participation in more than 2 drug studies in the last 12 months
             (exclusive of the current study)
Study Evaluating Nelotanserin for Treatment of REM Sleep Behavior Disorder in Subjects With Dementia (DLB or PDD)
Condition: Dementia With Lewy Bodies; REM Sleep Behavior Disorder; Parkinson's Disease Dementia
MeSH terms: Parkinson Disease; Dementia; Alzheimer Disease; Lewy Body Disease; REM Sleep Behavior Disorder; Mental Disorders
Intervention: Nelotanserin; Placebo
Intervention description: once daily, oral, 20-mg tablets; once daily, oral, matching tablets
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 34.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: Dementia with Lewy bodies; Lewy bodies; REM sleep behavior disorder; Parkinson's disease dementia

Summary:

      This study seeks to evaluate the safety and efficacy of Nelotanserin for the treatment of
      Rapid Eye Movement (REM) Sleep Behavior Disorder (RBD) in subjects with dementia with Lewy
      bodies (DLB) or Parkinson's disease dementia (PDD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult subjects at least 50 years of age, with a diagnosis of DLB or PDD and RBD based
             on Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM-5)
             diagnostic criteria

          -  Presence of frequent REM sleep behavior episodes

          -  Mini Mental State Examination score ≥ 18

        Exclusion Criteria:

          -  Subjects have a current diagnosis of significant psychotic disorders including, but
             not limited to, schizophrenia or bipolar disorder

          -  Subjects' RBD symptoms are secondary to or better accounted for by another medical
             condition, psychiatric disorder, or substance abuse

          -  Subjects with a current serious and/or unstable cardiovascular, respiratory, thyroid,
             gastrointestinal, renal, hematologic or other medical disorder
Preventing Urinary Tract Infection Post-Surgery
Condition: Urinary Tract Infection
MeSH terms: Infections; Communicable Diseases; Urinary Tract Infections
Intervention: Cranberry powder capsules; Placebo powder capsules
Intervention description: 2 cranberry powder capsules twice a day; 2 placebo capsules twice a day
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 200.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: cystitis; pyelonephritis; bladder infection; kidney infection

Summary:

      Approximately 10-27% of patients undergoing gynecologic surgeries develop a catheter
      associated urinary tract infection (CAUTI) in the post operatory period, as bladder
      catheterization is a common practice in gynecologic surgery. Cranberry products provide
      alternative means for preventing CAUTI and could result in decreased use of antimicrobials.
      In this pilot study we will enroll 200 women post gynecologic surgery and randomize them to
      take either cranberry powder capsules or placebo powder capsules. The low risk of harm
      associated with using cranberry to reduce UTI coupled with its potential benefit makes it a
      desirable intervention for the prevention of CAUTI. The conduct/ results of this pilot
      /feasibility study will prepare us for the conduct of a large scale clinical trial.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Presenting at the gynecology clinic for a pre-operatory visit

          2. Ability to give informed consent

          3. Willing to take cranberry capsules for up to 6 weeks

          4. 18 of age or older

        Exclusion Criteria:

          1. Pregnancy

          2. History of nephrolithiasis

          3. History of allergy to cranberry

          4. Patient on anticoagulant medicine to be re-started during the 4-6 weeks after surgery

          5. Less than 18 years old
OBS in Adolescent and Adults With EOE: A Phase II, Randomized, Double-Blind, Placebo Controlled, Study With an Open Label Extension
Condition: Eosinophilic Esophagitis (EoE)
MeSH terms: Esophagitis; Eosinophilic Esophagitis
Intervention: Oral Budesonide Suspension (MB-9); Placebo
Intervention description: OBS suspension to be taken bid over a 16 week course of double blind therapy and OBS suspension to be taken qd to bid during a 24 week optional open label extension period
Intervention MeSH terms: Budesonide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 93.0
Sex: All
Minimum age: 11 Years
Maximum age: 40 Years
Healthy volunteers: No
Keywords: EoE

Summary:

      This is a clinical trial to test an experimental drug for the treatment of Eosinophilic
      Esophagitis (EoE)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and Females, age 11-40

          -  Histologic evidence of EoE

          -  History of clinical symptoms of EoE including dysphagia

          -  Willing to continue with dietary, environmental or medical therapy

          -  Ability to read and understand english

          -  Written Consent

        Exclusion Criteria:

          -  Any Medical condition that may compromise the safety of the subjects or interfere with
             the signs and symptoms of EoE

          -  Use of immunomodulatory therapy

          -  Current use of swallowed corticosteroids

          -  Esophageal strictures,varices or upper GI bleed

          -  Other current diseases of the GI tract

          -  Current viral infection or immunodeficiency condition

          -  Pregnancy

          -  Hypersensitivity to budesonide

          -  History of non compliance
Phase 2 Study of TR-701 in Patients With Complicated Skin and Skin Structure Infections
Condition: Skin Diseases, Infectious; Skin Diseases, Bacterial
MeSH terms: Infections; Communicable Diseases; Skin Diseases, Bacterial; Skin Diseases, Infectious; Skin Diseases
Intervention: TR-701 200 mg; TR-701 300 mg; TR-701 400 mg
Intervention description: oral TR-701 200 mg for 5 to 7 days; oral TR-701 300 mg for 5 to 7 days; TR-701 400 mg for 5 to 7 days
Intervention MeSH terms: Tedizolid phosphate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 192.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Skin; Infection; Complicated Skin and Skin Structure Infection

Summary:

      The purpose of the study is to determine the oral dosage of TR-701 to be used in Phase III
      studies in patients with complicated skin and skin structure infections.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosed with complicated skin and skin structure infection with at least 2 signs and
             symptoms

          -  Suspected or confirmed infection due to a gram-positive organism

        Exclusion Criteria:

          -  Complicated skin and skin structure infection due to gram-negative organisms

          -  Complicated skin and skin structure infections requiring more than 7 days of therapy

          -  Uncontrolled diabetes

          -  Chronic systemic immunosuppressive therapy

          -  AIDS with CD4 count < 200 cells/mm3

          -  Uncontrolled hypertension

          -  Mild moderate or severe renal failure

          -  Severe hepatic disease

          -  Neutropenia

          -  Use of antidepressants such as SSRIs or MAOIs for 14 days before first dose of study
             drug

          -  Women who are pregnant or nursing
Apnea, Bariatric Surgery Versus Continuous Positive Airway Pressure (CPAP) Trial
Condition: Obstructive Sleep Apnea; Obesity
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Intervention: Laparoscopic Gastric Banding; Continuous Positive Airway Pressure
Intervention description: Those randomized to surgery would meet with the bariatric surgeon and the dietitian during the 3 month weight management period and based on insurance requirements, would undergo LGB surgery after 3 months of weight management. PAP therapy would be utilized for the 3 week peri-operative period (1 week prior to 2 weeks post-operatively) given evidence that this might reduce peri-operative respiratory complications. Routine surgical follow-up will occur 2 weeks post-operatively and then every 4-6 weeks to assess weight loss trajectory and adjust the band as needed.; Participants randomized to the CPAP arm will undergo a CPAP titration within 2 weeks of enrollment unless a split-night study was already performed as part of their diagnostic polysomnogram (PSG) providing a reliable CPAP therapeutic pressure. As soon as an appropriate pressure is identified, CPAP therapy will begin with routinely scheduled follow-up visits to maximize CPAP adherence. All participants will be offered a 12 month supervised weight loss program in addition to OSA-specific therapy.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 53.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the feasibility of conducting a comparative
      effectiveness study comparing a medical versus surgical approach to the initial management of
      obstructive sleep apnea (OSA) in the setting of obesity.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Severe sleep apnea with at least 1 referable symptom

          -  Obesity (BMI 35-45 kg/m2)

        Exclusion Criteria:

          -  Prior use of CPAP within the last two years or prior bariatric surgery

          -  Hypoxemia or hypercapnia

          -  Elevated peri-operative risk

          -  Drowsy driving in past year

          -  Unstable medical or psychiatric conditions
The Antihypertensives and Vascular, Endothelial and Cognitive Function Trial
Condition: Cognitive Impairment; Hypertension; Aging
MeSH terms: Cognitive Dysfunction
Intervention: candesartan; lisinopril; hydrochlorothiazide; nifedipine, long acting; metoprolol, long-acting
Intervention description: orally 8 mg increased to 16 mg then 32 mg to achieve target blood pressure of 140/90, then daily for 12 months; orally 10 mg increased to 20 mg then 40 mg to achieve target blood pressure of 140/90, then daily for 12 months; orally 12.5 mg increased to 25 mg to achieve target blood pressure of 140/90, then daily for 12 months; If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 30 mg increased to 60 mg and 90 mg in 2 week increments; If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 12.5 mg increased to 25 mg and 50 mg
Intervention MeSH terms: Metoprolol; Hydrochlorothiazide; Candesartan; Candesartan cilexetil; Lisinopril; Nifedipine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 53.0
Sex: All
Minimum age: 60 Years
Healthy volunteers: No
Keywords: cognitive disorders; angiotensin receptor blockers

Summary:

      The purpose of this study is to examine the effects of blood pressure medications on
      cognition and blood flow in hypertensive elderly patients with cognitive impairment. The
      hypothesis is that treatment with an angiotensin receptor blocker (ARB) or an
      angiotensin-converting enzyme inhibitor (ACEI) will be associated with a slower rate of
      further cognitive decline, improved cerebral blood flow and its regulation, and preserved
      physical function as compared to treatment with a diuretic (HCTZ), independent of blood
      pressure level.
    

Eligibility criteria:

        Inclusion Criteria:

          -  60 years or older

          -  Hypertension

          -  Cognitive criteria: score either 10 or less out of 15 for the executive clock draw
             test 1 (CLOX1) or less than or equal to 1 standard deviation from the corresponding
             age specific mean on the immediate memory subtest

        Exclusion Criteria:

          -  Intolerance to ACEI or ARB

          -  History of congestive heart failure

          -  History of diabetes mellitus

          -  History of stroke (less than 6 months)