bioihbjkbjnl/mcl2 huggingface dataset:
Clozapine for Cannabis Use in Schizophrenia
Condition: Schizophrenia; Cannabis Abuse; Cannabis Dependence; Dual Diagnosis
MeSH terms: Marijuana Abuse; Schizophrenia
Intervention: Clozapine; Risperidone
Intervention description: Clozapine: target dose of 400mg per day with a maximum dose of 550mg per day; Clozapine: target dose of 4mg per day with a maximum dose of 6mg per day
Intervention MeSH terms: Risperidone; Clozapine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 49.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: Schizophrenia; Cannabis Abuse; Cannabis Dependence; Dual Diagnosis; Clozapine; Risperidone

Summary:

      Many individuals with schizophrenia also suffer from marijuana addiction that worsens their
      problems related to schizophrenia. Most of the medications prescribed for schizophrenia have
      no effect on reducing marijuana use. Preliminary data suggests that clozapine, an atypical
      antipsychotic, may limit marijuana use in people diagnosed with schizophrenia, but it is not
      commonly used due to its side effects and is reserved for people who do not respond to other
      antipsychotic medications.

      In the proposed study, 132 individuals who are diagnosed with both schizophrenia and a
      cannabis use disorder will be randomized to a 12-week treatment course with either clozapine
      or risperidone (another commonly prescribed antipsychotic medication) to test the hypothesis
      that patient treated with clozapine will have decreased cannabis use as compared to patients
      treated with risperidone.

      Should this study indicate that clozapine will lessen marijuana use in persons diagnosed with
      schizophrenia more than risperidone, it will provide evidence needed to begin to shift
      clinical practice toward its use in this population.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of schizophrenia

          -  Clinical diagnosis of a cannabis use disorder (abuse or dependence)

        Exclusion Criteria:

          -  Pregnant,trying to become pregnant or nursing

          -  History of a seizure disorder

          -  Current treatment with clozapine or risperidone

          -  Contraindication to treatment with clozapine or risperidone
Comparison of Corticosteroid Dosing Regimens After Endothelial Keratoplasty
Condition: Fuchs' Dystrophy; Corneal Edema
MeSH terms: Corneal Edema; Fuchs' Endothelial Dystrophy
Intervention: loteprednol etabonate; prednisolone acetate 1%
Intervention MeSH terms: Loteprednol Etabonate; Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 167.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Graft rejection has traditionally been one of the leading causes of cornea transplant
      failure. To help prevent rejection, corticosteroid eye drops are used for an extended period
      after transplant surgery. The purpose of this study is to compare the efficacy and side
      effects of different corticosteroid dosing regimens after endothelial keratoplasty (cornea
      transplant) surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  At least 18 years of age

          -  Male or female patient who had endothelial keratoplasty procedure within the past 1 to
             7 weeks

          -  Patient is able and willing to administer eye drops

          -  Patient is able to comprehend and has signed the Informed Consent form.

          -  Patient is likely to complete the one-year course of the study

        Exclusion Criteria:

          -  A history of a previous rejection episode in the study eye

          -  A patient exhibiting intraocular inflammation

          -  A patient with a known sensitivity to any of the ingredients in the study medications

          -  A patient who has a condition (i.e., UNCONTROLLED systemic disease) or is in a
             situation which in the investigator's opinion may put the patient at significant risk,
             may confound the study results, or may interfere significantly with the patient's
             participation in the study

          -  A patient with abnormal eyelid function.

          -  A patient that is exhibiting active corneal ulceration, keratitis, or conjunctivitis,
             or who has a history of herpetic keratitis.

          -  Presence of any ocular disease that would interfere with the evaluation of the study
             treatment. However, patients with a history of cystoid macular edema, age-related
             macular degeneration, controlled glaucoma, corneal neovascularization, and other
             non-interfering comorbidities may be enrolled.

          -  A patient with a history of non-compliance with using prescribed medication.

          -  A patient who is concurrently involved in or participated in another randomized
             clinical trial within 30 days prior to enrollment in this study.

          -  Patients who are pregnant or planning to become pregnant within the duration of the
             study
A Clinical Trial Comparing Efficacy and Safety of Exubera® and Humalog®
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: Inhaled Human Insulin (Exubera®); Insulin lispro (Humalog)
Intervention description: Preprandial inhaled insulin regimen and administration of insulin glargine QD; Subcutaneous insulin regimen of pre-prandial insulin lispro and administration of insulin glargine QD.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Lispro
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 58.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To compare efficacy and safety of Exubera® vs Humalog in patients with type 1 diabetes
      mellitus
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diabetes mellitus Type 1

        Exclusion Criteria:

          -  Severe Asthma, severe Chronic Obstructive Pulmonary Disease (COPD)

          -  Smoking
A Trial of Intravenous Calcium and Myocardial Diastolic Dysfunction During Separation From Cardiopulmonary Bypass
Condition: Diastolic Dysfunction
Intervention: Calcium Chloride; Placebo
Intervention description: Calcium chloride 10mg/kg in 50cc NS delivered over 5 minutes; Normal saline, 50cc delivered over 5 minutes
Intervention MeSH terms: Calcium
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Separation; Cardiopulmonary bypass; Calcium chloride

Summary:

      Successful heart surgery requires the resumption of a strong beating heart prior to
      separation from the heart and lung machine. There are different ways to do this. At this
      hospital, the surgical team usually gives calcium to people when they come off of the heart
      and lung machine because some doctors believe that calcium can "jump start" the heart. Not
      every hospital does this.

      Some people think that calcium may have a side effect of making the heart more stiff. Stiff
      hearts do not beat as well or receive as much blood to tissues as non-stiff hearts. If
      calcium makes the heart stiff, then doctors may have to use other medicines to support the
      heart in the operating room and the intensive care unit. This may ultimately lead to poorer
      outcomes including a longer stay in the intensive care unit and in the hospital.

      This study is being performed to find out if calcium has the side effect of making the heart
      more stiff. This study compares calcium to placebo. The placebo looks exactly like the
      calcium, but it contains no calcium. During this study patients may receive placebo instead
      of calcium. Neither the doctor nor the study team will know which drug the subject will
      receive.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and women greater than 18 years of age

          -  Undergoing primary elective valve surgery at Brigham and Women's Hospital

          -  Consented for Transesophogeal Echocardiography (TEE) as part of routine
             intra-operative care and monitoring

        Exclusion Criteria:

          -  Patients not consented for TEE as part of routine intra-operative care

          -  Any absolute contraindication to TEE

          -  Ionized calcium level < 0.80 mmol/L near separation from CPB

          -  Myocardial infarction (MI) or acute coronary syndromes < 3 months prior to surgery due
             to the presence of pre-operative diastolic dysfunction in infarcted or ischemic
             myocardium

          -  Ejection fraction (EF) < 35%

          -  Atrial fibrillation / flutter the absence of an A wave on mitral inflow Doppler

          -  Heart rate (HR) > 100 during 2 data point collections due to E / A wave
             superimposition
Loiasis Cross-reactive Antigenemia and Treatment-related Adverse Events
Condition: Loiasis
MeSH terms: Loiasis
Intervention: Ivermectin
Intervention description: single dose, 150 ug/kg
Intervention MeSH terms: Ivermectin
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 41.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study seeks to determine which Loa loa antigens are released into circulation when
      infected individuals are treated with ivermectin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Loa loa blood microfilariae of between 5,000 - 18,000 per mL

        Exclusion Criteria:

          -  known allergy to ivermectin; severe comorbidities
TAP Block With Liposomal Bupivacaine Versus Bupivacaine in Robotic Hysterectomy
Condition: Acute Pain
MeSH terms: Acute Pain
Intervention: Bupivacaine; liposomal bupivacaine
Intervention MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of the study is to compare pain control after robotic hysterectomy surgery using
      either liposomal bupivacaine or Bupivacaine when injected during a transversus abdominis
      plane (TAP) block. Robotic hysterectomy is when a patient is electively having robotic
      assisted removal of one's uterus. Both medications liposomal bupivacaine and Bupivacaine are
      standard of care in these types of surgeries.
    

Eligibility criteria:

        Inclusion Criteria:

          -  those who present for elective robotic assisted hysterectomy

        Exclusion Criteria:

          -  non english speaking

          -  chronic pain

          -  on opioids greater than 1 weeks

          -  chronic anticoagulation

          -  allergy to local anesthetics

          -  use of spinal or epidural for surgery

          -  lack of patient cooperation

          -  contraindication to regional anesthesia
Pregabalin on Colonic Motor and Sensory Function in Constipation Predominant Irritable Bowel Syndrome
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome; Constipation
Intervention: Pregabalin; Placebo
Intervention description: FDA approved medication (capsules) at 200mg dose.; Placebo capsules
Intervention MeSH terms: Pregabalin
Phase: Phase 4
Study type: Interventional
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Pregabalin; Irritable Bowel Syndrome; motor; sensation; colon; human

Summary:

      The general aim of the current study is to describe the effect of pregabalin on colonic and
      sensory functions in adults with constipation predominant irritable bowel syndrome (IBS-C).

      Study hypotheses:

        1. Single-dose pregabalin 200mg increases sensation thresholds and decreases sensation
           ratings in response to balloon distension in the colon relative to pre-pregabalin
           treatment.

        2. Single-dose pregabalin 200 mg will increase colonic compliance and decrease colonic pain
           and gas thresholds in patients with irritable bowel syndrome constipation predominant.

        3. Single-dose pregabalin 200mg increases the colonic phasic and tonic response to a
           standardized meal.
    

Eligibility criteria:

        Inclusion criteria:

        - Male or females with Constipation Predominant IBS, age 18-65

        Exclusion criteria:

          -  Abdominal surgery other than appendectomy, laparoscopic cholecystectomy, cesarean
             section, vaginal or laparoscopic hysterectomy or tubal ligation

          -  Uncontrolled hypertension

          -  Use of medications that may interact with the study medication

          -  Use of any of the study medications within the past 30 days

          -  Pregnancy

          -  History of chronic renal insufficiency (serum creatinine >1.5mg/dL)

          -  Psychiatric or psychologic dysfunction

          -  Current pelvic floor dysfunction

          -  diagnosis of lactose intolerance
Evaluating Etanercept Use in Patients With Moderate to Severe Rheumatoid Arthritis Who Have Lost Response to Adalimumab
Condition: Moderate to Severe Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Etanercept; Methotrexate
Intervention description: Administered by subcutaneous injection; Background methotrexate at least 15 mg weekly
Intervention MeSH terms: Etanercept; Methotrexate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 90.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: rheumatoid arthritis; etanercept; arthritis; adalimumab failure to respond; loss of response to adalimumab; ACR20; methotrexate; Swollen joints; tender joints

Summary:

      To evaluate the efficacy of etanercept in adults with moderate-to-severe rheumatoid arthritis
      (RA) who did not respond to or lost a satisfactory response to adalimumab when used as their
      first biologic agent.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Able to provide informed consent

          -  Diagnosed with moderate to severe rheumatoid arthritis for at least 6 months

          -  Active RA with at least 3 swollen and tender joints

          -  Failure to respond to a combination treatment of adalimumab and methotrexate (must
             have taken combination at least 3 months) or loss of a satisfactory response to the
             combination of adalimumab and methotrexate, which was taken for at least 6 months (if
             currently taking adalimumab must complete 2 weeks without it prior to starting study
             drug)

          -  Negative for hepatitis B and C

          -  Negative serum and urine pregnancy tests before starting study

          -  currently taking (stable dose) 15 mg methotrexate weekly for at least 8 weeks/has been
             taking methotrexate for at least 12 weeks total - lower dose of 10 mg per week is
             permitted with documented intolerability

          -  Normal chest X-ray within 3 months

          -  Negative testing for tuberculosis (TB)

        Exclusion Criteria:

          -  Class IV RA (wheel-chair or bed-bound)

          -  Significant concurrent medical conditions, including: (uncontrolled type 1 diabetes,
             poorly controlled type 2 diabetes, symptomatic heart failure, myocardial infarction in
             past year, history of unstable angina within past year, uncontrolled hypertension,
             severe chronic pulmonary disease, major chronic inflammatory or connective tissue
             disease other than RA, Multiple sclerosis, active malignancy, or history of cancer,
             alcoholic hepatitis or history of alcoholic liver disease)

          -  Other inclusion/exclusion criteria may apply
PROlonGed ExpoSure Sertraline
Condition: Posttraumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Intervention: Sertraline; Prolonged Exposure Therapy
Intervention description: Initial baseline dose of 25 mg/day. Clinician will attempt to titrate patients to at least 100 mg/day and up to 200 mg/day if tolerated by week 8.; up to 13 sessions of prolonged exposure
Intervention MeSH terms: Sertraline
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 223.0
Sex: All
Healthy volunteers: No
Keywords: combat-related PTSD; Posttraumatic stress disorder; prolonged exposure therapy; sertraline; military; veterans; VA hospital; mental illness

Summary:

      The current research study aims to compare the effectiveness of two proven treatments for
      posttraumatic stress disorder (PTSD): Prolonged Exposure (PE), sertraline, and their
      combination. In addition, the investigators are examining predictors of response to these two
      treatments and how PTSD symptoms, thoughts, and biological factors may be changed by such
      treatments. Biological mechanisms of change are also examined including emotion processing
      and regulation in fMRI, HPA axis function, and genetics and genomics. In addition, the
      investigators will examine acceptability of each treatment and reasons for ending treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient is an Operation Enduring Freedom/Operation Iraqi Freedom/Operation New Dawn
             (OEF/OIF/OND) combat veteran with chronic posttraumatic stress disorder (PTSD) or
             significant PTSD symptoms (Clinician Administered Posttraumatic Stress Disorder Scale
             [CAPS] >= 50) of at least 3 months duration

        Exclusion Criteria:

          -  Current, imminent risk of suicide (as indicated on C-SSRS)

          -  Active psychosis

          -  Alcohol or substance dependence in the past 8 weeks

          -  Unable to attend regular appointments

          -  Prior intolerance or failure of adequate trial of prolonged exposure (PE) or
             sertraline (SERT) (defined as at least 2 months of SERT at least 100mg/day)

          -  Medical illness likely to result in hospitalization or for which treatments are
             contraindicated (based on lab results, medical history and physical exam)

          -  Serious cognitive impairment (as evidenced by cognitive impairment felt likely to
             interfere with the ability to participate meaningfully in the study)

          -  Concurrent antidepressants or antipsychotics

          -  Pregnant females
Long-Term Efficacy & Safety of Aflibercept IVT for the Treatment of DME in Subjects Who Completed the VISTA-DME Trial
Condition: Diabetic Macular Edema
MeSH terms: Macular Edema
Intervention: Aflibercept; Focal Laser
Intervention description: pro re nata (PRN); Focal laser administered based on pre-specified criteria
Intervention MeSH terms: Aflibercept
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The Endurance Trial is a phase IV open label clinical study to assess the need for ongoing
      intravitreal aflibercept injections after the 3-year VISTA DME (VGFT-OD-1009; NCT01363440)
      end-point. Subjects will be treated with intravitreal aflibercept injections pro re nata
      (PRN) based on the presence of CR-DME (Clinically Relevant-DME). In addition, subjects who
      meet re-treatment criteria will be eligible for focal laser treatment every 90 days.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A subject must meet the following criteria to be eligible for inclusion in the study:

               1. Enrolled and Completed VISTA DME (VGFT-OD-1009) clinical trial

               2. Willing and able to comply with clinic visits and study-related procedures

               3. Provide signed informed consent

               4. Enrollment in the trial within 12 weeks of trial activation.

        Exclusion Criteria:

          -  A subject who meets any of the following criteria will be excluded from the study:

               1. Prior treatment with anti-VEGF therapy in the study eye within 28 days of
                  baseline

               2. Pregnant or breast-feeding women

               3. Sexually active men* or women of childbearing potential** who are unwilling to
                  practice adequate contraception during the study (adequate contraceptive measures
                  include stable use of oral contraceptives or other prescription pharmaceutical
                  contraceptives for 2 or more menstrual cycles prior to screening; intrauterine
                  device [IUD]; bilateral tubal ligation; vasectomy; condom plus contraceptive
                  sponge, foam, or jelly, or diaphragm plus contraceptive sponge, foam, or jelly).

                    -  Contraception is not required for men with documented vasectomy.
                       **Postmenopausal women must be amenorrheic for at least 12 months in order
                       not to be considered of child bearing potential. Pregnancy testing and
                       contraception are not required for women with documented hysterectomy or
                       tubal ligation.