bioihbjkbjnl/mcl2 huggingface dataset:
Monoamine Contributions to Neurocircuitry in Eating Disorders
Condition: Eating Disorder
MeSH terms: Feeding and Eating Disorders
Intervention: [11C]raclopride; [11C]DASB; amphetamine
Intervention description: 1.[11C]raclopride -The change (Δ) in BPND (the difference between the [11C]raclopride BPND at baseline and post-AMPH treatment normalized to the baseline BPND; BPND of [11C]DASB.; The change (Δ) in BPND (the difference between the [11C]raclopride BPND at baseline and post-AMPH treatment normalized to the baseline BPND.
Intervention MeSH terms: Raclopride; Amphetamine; Dextroamphetamine
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 88.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study will use brain imaging technologies to measure several neurotransmitters
      (serotonin and dopamine) that contribute to our abilities to respond to reward or inhibit our
      impulses, and which are known to be altered in the brain of people with anorexia nervosa (AN)
      and bulimia nervosa (BN). Because palatable food stimulates dopamine secretion, we propose to
      use a challenge with brain imaging that will stimulate dopamine release which we hypothesize
      will generate anxiety rather than pleasure in AN, and will help explain why AN restrict
      eating in order to reduce anxiety. This study will help to understand the unique puzzling
      symptoms in eating disorders and contribute to finding better methods for identifying
      effective treatments for these often relapsing and sometimes chronic disorders.
    

Eligibility criteria:

        Inclusion

          -  history of Diagnostic and Statistical Manual (DSM-IV) diagnosis of anorexia or
             bulimia.

          -  AN women have history of average body weight (ABW) below 85% for height.

          -  AN-BN subjects have history of ABW below 85% ABW.

          -  AN-BN subjects have history of binging/purging behaviors during a period of low
             weight.

          -  Subjects must be right-handed.

          -  Subjects have been recovered for 12 months or more.

        Exclusion

          -  Diagnosis of alcohol or drug abuse or dependence in the 3 months.

          -  Alcohol or substance use within 30 days.

          -  Current diagnosis of an Axis I disorder.

          -  Organic brain syndromes, dementia, psychotic disorders, or mental retardation.

          -  Neurological or medical disorders such as seizure disorder, renal disease, diabetes,
             thyroid disease, EKG indicative of electrolyte imbalance

          -  BN subjects whose purging methods were the use of laxatives, diuretics

          -  Use of psychoactive medication in the 3 months.

          -  Pregnancy or lactation.

          -  Tobacco use in the 3 months.
Efficacy and Tolerability of Switching to Ziprasidone From Other Antipsychotics
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Intervention: ziprasidone
Intervention description: Ziprasidone by mouth 40mg twice a day (bid) for one day, then 80mg bid; may be increased to 120mg bid after three weeks
Intervention MeSH terms: Ziprasidone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Schizophrenia; Ziprasidone

Summary:

      Because ziprasidone has not been extensively studied and is not widely accepted in the
      severely mentally ill in State hospitals this study aims to demonstrate its effectiveness and
      relative lack of side effects. 75 patients with schizophrenia or schizoaffective disorder who
      need a change of medication because of ineffectiveness or side effects will be changed to
      ziprasidone and followed with detailed assessments for eight weeks.

      The hypothesis is that they will improve and have fewer side effects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Schizophrenia or schizoaffective

          -  Capacity to give consent

          -  Stable, on the same medication for a month but only partial response or with
             unacceptable side effects 18-65 years of age

        Exclusion Criteria:

          -  Repeated non-compliance

          -  Current depot medication

          -  Active medical conditions

          -  QTc >500msec

          -  Previous non-response

          -  Previous treatment with ziprasidone
A Study of Apixaban in Patients With Atrial Fibrillation, Not Caused by a Heart Valve Problem, Who Are at Risk for Thrombosis (Blood Clots) Due to Having Had a Recent Coronary Event, Such as a Heart Attack or a Procedure to Open the Vessels of the Heart
Condition: Acute Coronary Syndromes
MeSH terms: Atrial Fibrillation; Acute Coronary Syndrome; Syndrome
Intervention: Apixaban; vitamin K antagonist; Acetylsalicylic acid; Acetylsalicylic acid placebo
Intervention MeSH terms: Aspirin; Vitamin K; Apixaban
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Enrollment: 4614.0
Sex: All
Minimum age: 18 Years
Maximum age: 95 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine if Apixaban is safer than a Vitamin K Antagonist
      given for 6 months in terms of bleeding in patients with an irregular heart beat (atrial
      fibrillation) and a recent heart attack or a recent procedure to open up a blood vessel in
      the heart. All patients would also be taking a class of medicines called P2Y12 inhibitors
      (such as clopidogrel/Plavix) and be treated for up to 6 months. The primary focus will be a
      comparison of the bleeding risk of Apixaban, with or without aspirin, versus a Vitamin K
      antagonist, such as warfarin, with or without aspirin.
    

Eligibility criteria:

        For more information regarding BMS clinical trial participation, please visit
        www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Adults with either active or a history of non-valvular atrial fibrillation or flutter
             with the planned or existing use of an oral anticoagulant for prophylaxis of
             thromboembolism. In addition, subjects must have had an acute coronary syndrome or
             percutaneous coronary intervention with a stent within the prior 14 days

          -  Planned use of antiplatelet agents for at least 1 to 6 months

          -  Males and Females ≥ 18 years of age

          -  Women of childbearing potential must have a negative serum or urine pregnancy test
             within 24 hours prior to the start of study drug

        Exclusion Criteria:

          -  Conditions other than atrial fibrillation that require chronic anticoagulation. (e.g.
             prosthetic mechanical heart valve)

          -  Severe renal insufficiency (serum creatinine > 2.5 mg/dL or a calculated creatinine
             clearance < 30 mL/min

          -  Patients with a history of intracranial hemorrhage

          -  Patients have had or will undergo Coronary arterial bypass graft (CABG) for their
             index acute coronary syndrome (ACS) event

          -  Patients with known ongoing bleeding and patients with known coagulopathies

          -  Any contraindications or allergies to VKA, apixaban, or to intended P2Y12 antagonists
             or to aspirin
Panel Reactive Antibody (PRA) Reduction in Sensitized Patients Awaiting Renal Transplantation
Condition: End Stage Renal Disease
MeSH terms: Kidney Failure, Chronic
Intervention: CMVIG
Intervention description: 400mg/kg IV (60mg/kg/IV/hr initially, titrated up) once a week up to four weeks
Intervention MeSH terms: Immunoglobulins
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 26.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Renal; Transplant; PRA

Summary:

      The purpose of this study is to offer Panel Reactive Antibodies [PRA] reduction treatment to
      high responder renal transplant patients who otherwise may never be compatible with a
      potential organ donor. PRA reduction is offered in the following phases:

        1. Immunological Testing

        2. Transplant Nephrectomy

        3. Pharmacologic Therapy

        4. Plasmapheresis

        5. Transplant
    

Eligibility criteria:

        Inclusion Criteria:

          -  Renal transplant recipients with a potential living donor who is incompatible (T-&/or
             B-cell locus) due to recipient high PRA or MHC antibodies

          -  PRA greater than or equal to 20% within last twelve months

          -  Recipient and donor accepted as potential candidates by the LifeLink Healthcare Renal
             Transplant Committee

        Exclusion Criteria:

          -  Patients with known allergy to CytoGam(R), Cellcept, Rapamycin

          -  Patients who will receive IVIG or CytoGam(R) for any cause prior to protocol process

          -  ABO incompatibility

          -  Patients not capable of following through the treatment for various reasons as
             determined by treating physicians

          -  Any potential recipient who is pregnant or becomes pregnant

          -  Exclusion for Plasmapheresis: known allergy to ethylene oxide or natural rubber latex.

          -  Exclusion for Plasmapheresis: Intake of ACE-inhibitor or Angtiotensiin-receptor
             blockers in the last 24 hours prior to plasma exchange
Lamotrigine add-on Therapy for Bipolar Disorder and Cocaine Dependency
Condition: Bipolar Disorder; Cocaine Dependence
MeSH terms: Cocaine-Related Disorders; Bipolar Disorder
Intervention: Lamotrigine; Placebo
Intervention description: Lamotrigine; Placebo
Intervention MeSH terms: Lamotrigine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 112.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Bipolar Disorder; Cocaine Dependence; Dual Diagnosis

Summary:

      The purpose of this study is to determine if lamotrigine add-on therapy is associated with
      decreased cocaine craving and improvement in depressive symptom severity than placebo in a
      group of outpatients with bipolar disorder and cocaine dependence. Additionally, this study
      is examining whether lamotrigine add-on therapy is associated with decreased cocaine use and
      the improvement of manic symptom severity than placebo in a group of outpatients with bipolar
      disorder and cocaine dependence.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of bipolar I, II, not otherwise specified or cyclothymic disorders

          -  Currently depressed or mixed mood state

          -  Ages 18-70 years

          -  Men or women

          -  Self-reported cocaine use within 14 days prior to randomization

          -  English or Spanish speaking

          -  Baseline Hamilton Depression Rating Scale (HRSD17) score ≥ 10

        Exclusion Criteria:

          -  Currently taking an enzyme inducing or inhibiting anticonvulsant (e.g. valproic acid,
             carbamazepine)

          -  Current severe psychotic features (e.g. daily auditory hallucinations, fixed
             delusions, severely disorganized thought processes) that require antipsychotic
             therapy, and that do not appear to be secondary to cocaine use

          -  Active suicidal ideation (plan and intent) or ≥2 attempts in past 12 months or any
             attempt in the past month

          -  Highly unstable medical condition

          -  Change in concomitant psychiatric medications (e.g. initiated antipsychotic) or in
             other substance abuse treatment (e.g. began intensive outpatient treatment) within 7
             days prior to study entry

          -  Vulnerable populations (e.g. pregnant or nursing women, prisoners, mentally retarded)
Uterotonic Prophylaxis Trial
Condition: Hemorrhage
MeSH terms: Hemorrhage
Intervention: Methergine; placebo
Intervention description: 0.2 mg of methylergonovine maleate; saline placebo to maintain blinding
Intervention MeSH terms: Methylergonovine
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 284.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Excessive bleeding after dilation and evacuation (D&E) requiring interventions is common,
      occurring in approximately 30% of cases at one large abortion-providing clinic. Uterotonic
      prophylaxis at the time of D&E, particularly with methylergonovine maleate (MM), is a common
      practice among D&E providers despite nearly no evidence for its efficacy. Finding ways to
      decrease excessive bleeding after D&E has the potential both to improve patient safety and to
      reduce costs of provider-initiated interventions. The investigators propose a randomized,
      controlled trial to investigate the efficacy of MM prophylaxis versus placebo in decreasing
      excessive bleeding measured by a composite outcome among women undergoing D&E at 20 to 24
      weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Between 20 wks 0 days gestation and 24 wks 0 days gestation

          -  English or Spanish speaking

          -  BP before injection 140/90 or below

          -  18 years old or over

        Exclusion criteria:

          -  hypertension either on the preoperative or operative day (defined as systolic blood
             pressure greater than 140 mmHg or diastolic blood pressure greater than 90 mmHg)

          -  D&E procedures with more than one day of cervical preparation with dilators

          -  use of protease inhibitors

          -  known coagulopathy

          -  known morbidly adherent placenta
Comparison of Two Application Techniques for LET Gel
Condition: Lacerations; Pain, Procedural; LET
MeSH terms: Pain, Procedural; Lacerations
Intervention: LET Lidocaine (4%), Epinephrine (0.1%), and Tetracaine (0.5%) topical gel
Intervention description: Topical anesthetic
Intervention MeSH terms: Lidocaine; Epinephrine; Tetracaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Single-blinded randomized study; patients are randomized to one of two groups
Masking: Double (Care Provider, Outcomes Assessor)
Masking description: Investigator and nurse applied intervention and masked the intervention from the care provider. Separate nurse not caring for the patient, blinded to the intervention, brought in to obtain pain score (outcome)
Enrollment: 48.0
Sex: All
Minimum age: 7 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      Comparison of anesthetic efficacy of Lidocaine (4%), Epinephrine (0.1%), and Tetracaine
      (0.5%) topical gel (LET) applied three times for 10 minutes each time vs. once for 30 minutes
      prior to suturing simple lacerations in children aged 7-17 years.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Simple <= 3cm lacerations requiring suturing (as decided by clinician care providers)

          -  Plan to suture with simple interrupted sutures

        Exclusion Criteria:

          -  Lacerations involving the hands, feet, genitals, tongue, mucus membranes, nose, ears,
             or occurring over joints

          -  Patients whose primary language was neither English nor Spanish

          -  Developmentally delayed or disabled patient such that they were unable to give a pain
             score

          -  Patients requiring procedural sedation or anxiolysis with oral or intranasal midazolam
Bio-Behavioral Predictors of the Efficacy of Nicotine Replacement Therapy (NRT)
Condition: Smoking
Intervention: Nicoderm Transdermal Patch; Nicotine Nasal Spray
Intervention description: The dosing schedule is as follows: 4 weeks of 21mg per 24 hours, 2 weeks of 14mg per 24 hours, and 2 weeks of 7mg per 24 hours. Treatment lasted 8 weeks.; 8 weeks of self-administered nicotine nasal spray at 40 recommended doses per day, tapering by 1/3 for the last 4 weeks. Nasal spray dosing was 0.5 mg spray per nostril (1 mg) for a maximum of 5 doses per hour and 40 doses per day. This dosing schedule is based on the average nicotine intake per cigarette of 1 mg per cigarette. Treatment lasted 8 weeks.
Intervention MeSH terms: Nicotine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 674.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Nicotine nasal spray + counseling; Transdermal nicotine + counseling

Summary:

      The purpose of this research study is to:

        1. compare the effectiveness of a nicotine patch and nicotine nasal spray for smoking
           cessation; and

        2. identify predictors of response to these alternate forms of nicotine replacement therapy
           (NRT).
    

Eligibility criteria:

        Inclusion Criteria:

          -  The subjects will be male and female smokers age 18-75.

          -  Eligible smokers will be those currently smoking at least 10 cigarettes a day.

        Exclusion Criteria:

          -  Planning a pregnancy, pregnant, or lactating

          -  Current addiction to opiates, cocaine, or stimulants

          -  Skin allergies or chronic dermatitis (based on medical history/self-report)

          -  An Axis 1 major psychiatric disorder
Metformin, Muscle Energetics, and Vascular Function in Older Adults With Peripheral Artery Disease
Condition: Peripheral Artery Disease
MeSH terms: Peripheral Arterial Disease
Intervention: Metformin 1000 mg; Placebo
Intervention MeSH terms: Metformin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 2.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No

Summary:

      The investigators are doing this research study to find out if taking Metformin improves
      walking ability in patients with peripheral arterial disease (PAD). In PAD the arteries
      (blood vessels) in the legs are narrowed because of the build up of plaque. The leg muscle
      can hurt in patients with PAD and this is usually described as a cramp or tiredness. This
      pain is called intermittent claudication. Metformin is an FDA approved medication for the
      treatment of diabetes. The investigators believe that Metformin may help your leg muscles
      work better.

      The investigators will enroll up to 100 subjects in order to find 60 subjects with PAD at
      Brigham and Women's Hospital (BWH).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 40 years or greater

          -  Intermittent claudication for 6 months or greater

          -  Maximal walk time between 1-20 minutes on all ETTs

          -  Resting ABI ≤ 0.9 in index leg at baseline

          -  ABI falls ≥ 20% in index leg 1 minute post baseline ETT

          -  MWT variability < 20%

        Exclusion Criteria:

          -  Type 1 or Type 2 Diabetes

          -  Limb-threatening ischemia (rest pain, ulceration, gangrene)

          -  Peripheral vascular surgery or PCI within 6 months

          -  MI or CABG within 6 months

          -  Carotid endarterectomy (CEA) within 6 months

          -  Cerebrovascular accident or TIA within 6 months

          -  Uncontrolled hypertension (SBP > 140 mmHg, DBP >90 mmHg)

          -  Pentoxifylline/Cilostazol added/changed within 3 months

          -  HMG-CoA reductase inhibitor added/changed within 3 months

          -  Exercise limitations other than claudication (heart failure, angina, COPD, arthritis,
             neuropathy, etc.)

          -  Serum creatinine ≥ 1.5 mg/dL

          -  Pregnant or plans to become pregnant

          -  2 hour Oral Glucose Tolerance Test (OGTT) > 200 mg/dL
Steroids After Laser Trabeculoplasty for Glaucoma
Condition: Glaucoma
MeSH terms: Glaucoma
Intervention: Prednisolone 1%; Ketorolac; Artificial Tears
Intervention description: Prednisolone 1% to lasered eye 4 times/day for 4.5 days; Ketorolac 0.5% to lasered eye 4 times/day for 4.5 days; Artificial saline tears to lasered eye 4 times/day for 4.5 days
Intervention MeSH terms: Prednisolone; Prednisolone acetate; Ketorolac; Lubricant Eye Drops
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 97.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Glaucoma; Trabeculoplasty; Selective laser trabeculoplasty; Intraocular pressure

Summary:

      The purpose of this study is to determine whether the choice of post-operative eye drop
      administered after selective laser trabeculoplasty (SLT) for glaucoma affects the efficacy in
      lowering intraocular pressure (IOP).
    

Eligibility criteria:

        Inclusion Criteria:

          -  clinical diagnosis of glaucoma

          -  clinician has determined that SLT laser is indicated

          -  IOP currently >18 and was ever >21 in the past (e.g. prior to treatment)

        Exclusion Criteria:

          -  prior history of uveitis

          -  prior glaucoma surgery including glaucoma laser surgery

          -  pregnant or 3 months post-partum