bioihbjkbjnl/mcl2 huggingface dataset:
Ketamine Patient-Controlled Analgesia for Acute Pain
Condition: Acute Pain; Multiple Trauma; Fractures
MeSH terms: Acute Pain; Wounds and Injuries; Multiple Trauma
Intervention: Ketamine; Hydromorphone
Intervention description: Ketamine administered as patient-controlled analgesia.; Hydromorphone administered as patient-controlled analgesia.
Intervention MeSH terms: Ketamine; Hydromorphone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: pain; trauma

Summary:

      This study will compare ketamine and hydromorphone as alternative patient-controlled
      interventions for trauma-related pain. Patients receiving ketamine PCA are expected to
      require less total and breakthrough opioid and to have similar or improved objective pain
      scores. Patients receiving ketamine are also expected to have shorter duration of
      supplemental oxygen requirement, fewer episodes of oxygen desaturation, improved pulmonary
      toilet, lower use of antiemetics, and shorter times to first bowel movement. Ketamine is
      further expected to be associated with decreased intensive care unit and hospital lengths of
      stay, faster time to maximum allowable ambulation, decreased opioid dosage at discharge, and
      lower report of chronic pain syndromes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age greater than or equal to 18 years

          -  Total Injury Severity Score greater than 9

          -  Functioning intravenous catheter present per standard of care

          -  Patient planned to receive PCA for acute pain per standard of care

          -  Patient ability to effectively use a PCA device as assessed by the primary attending
             trauma service

          -  Negative pregnancy test for women of childbearing age

        Exclusion Criteria:

          -  Body mass index greater than 35

          -  History of active psychiatric disease

          -  Acute or chronic liver or renal failure

          -  History of heart failure or coronary artery disease

          -  Patients with documented chronic pain syndrome who use opioids as maintenance
             medication in outpatient therapy

          -  Patients who abuse alcohol and are at high risk for alcohol withdrawal

          -  Intubated patients

          -  Glasgow Coma Scale score less than 13, or motor subscore less than 6

          -  Documented allergy to ketamine, hydromorphone, or lorazepam

          -  Pregnancy

          -  Incarceration
Compassionate Use of Nitazoxanide for the Treatment of Clostridium Difficile Infection
Condition: Clostridium Enterocolitis; Pseudomembranous Colitis
MeSH terms: Enterocolitis, Pseudomembranous; Colitis; Enterocolitis
Intervention: Nitazoxanide
Intervention description: 500 mg bid
Intervention MeSH terms: Nitazoxanide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 22.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Clostridium difficile Associated Diarrhea

Summary:

      The purpose of this study is for compassionate use of nitazoxanide in the treatment of
      diarrheal disease due to Clostridium difficile infection when the patient has failed previous
      treatment with metronidazole or vancomycin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient must be > 18 years of age

          -  Clinical diagnosis of C. difficile associated disease, based on the new onset of
             diarrhea, abdominal discomfort, or otherwise unexplained fever or leukocytosis

          -  Diagnosis of C. difficile colitis proven by positive assay for C. difficile toxin in
             feces

          -  Disease has been treated, and the symptoms failed to respond to treatment with
             metronidazole or vancomycin, or symptoms promptly relapsed after completing a course
             of therapy with either of these drugs

          -  Able to take oral medication

        Exclusion Criteria:

          -  Patients with other recognized causes of diarrhea or colitis

          -  Women of child bearing age who are pregnant, breast feeding, or not using birth
             control

          -  Patients taking coumadin, phenytoin, celecoxib, or losartan

          -  Patients with renal insufficiency (BUN or creatinine >2 times baseline)

          -  Serious systemic disorder incompatible with the study
Reflux Esophagitis Phase III Study (Initial Treatment)
Condition: Reflux Esophagitis
MeSH terms: Gastroesophageal Reflux; Esophagitis; Esophagitis, Peptic
Intervention: Esomeprazole; Esomeprazole; Omeprazole
Intervention description: 20mg once daily; 40 mg once daily; 20mg once daily
Intervention MeSH terms: Esomeprazole; Omeprazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 602.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Reflux Esophagitis

Summary:

      This study is to evaluate the efficacy of esomeprazole 20 mg once daily and 40 mg once daily
      for 8 weeks on healing of Reflux Esophagitis in patients with reflux esophagitis in
      comparison with omeprazole 20 mg once daily by assessment of presence/absence of Reflux
      Esophagitis at Week 8 according to the Los Angeles classification .
    

Eligibility criteria:

        Inclusion Criteria:

          -  Endoscopically verified Reflux Esophagitis classified into Los Angeles classification
             Grade A, B, C or D within 1 week before randomisation

        Exclusion Criteria:

          -  Gastric or duodenal ulcer verified by EGD within 12 weeks before randomisation.

          -  Use of any PPI from 14 days before EGD performed at the screening visit to the day of
             randomisation.
Study Evaluating The Safety And Efficacy Of Desvenlafaxine Succinate For Vasomotor Symptoms In Menopausal Women
Condition: Vasomotor Symptoms
Intervention: desvenlafaxine succinate (DVS) SR; Placebo
Intervention description: Titration with 50 mg tablets once daily for 7 days, then 100mg tablets once daily from day 8 to day 365, then taper with 50 mg tablets once daily for 7 days, followed by 25 mg tablets once daily for 7 days.; Titration with 50 mg placebo tablets once daily for 7 days, then 100mg placebo tablets once daily from day 8 to day 365, then taper with 50 mg placebo tablets once daily for 7 days, followed by 25 mg placebo tablets once daily for 7 days.
Intervention MeSH terms: Desvenlafaxine Succinate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 2186.0
Sex: Female
Minimum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Menopause; Hot Flush; Hot Flash; Desvenlafaxine succinate Sustained Release

Summary:

      The purpose of the study is to evaluate the efficacy and safety of Desvenlafaxine Succinate
      (DVS) Sustained Release (SR), in comparison to placebo for the treatment of Vasomotor
      Symptoms (VMS) in menopausal women.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Generally healthy, postmenopausal women who seek treatment for hot flushes

          -  Body Mass Index (BMI) less than or equal to 34 kg/m^2

        Exclusion Criteria:

          -  Hypersensitivity to Venlafaxine

          -  Myocardial infarction an/or unstable angina within 6 months of screening

          -  History of seizure disorder
A Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Adults With Chronic Hepatitis C Virus (HCV) Genotype 2 Infection
Condition: Chronic Hepatitis C Virus (HCV) Infection
MeSH terms: Infections; Communicable Diseases; Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Intervention: ABT-493/ABT-530; Placebo for ABT-493/ABT-530
Intervention description: Tablet; ABT-493 coformulated with ABT-530; tablet
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 304.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: Treatment-Naive; Hepatitis C Virus Genotype 2; Sofosbuvir (SOF)-Experienced; Treatment-Experienced; Non-cirrhotic

Summary:

      The purpose of this study is to evaluate the safety and efficacy of ABT-493/ABT-530 in adults
      with genotype 2 chronic hepatitis C virus (HCV) infection.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Screening laboratory result indicating hepatitis C virus (HCV) Genotype-2 (GT2)
             infection.

          -  Chronic HCV infection.

          -  Subject must be HCV treatment-naïve (subject had never received a single dose of any
             approved or investigational regimen) or had failed prior interferon (IFN) or
             pegylated-interferon (pegIFN) ± ribavirin (RBV) or sofosbuvir (SOF) + RBV ± pegIFN
             therapy.

          -  Subject must be non-cirrhotic.

        Exclusion Criteria:

          -  History of severe, life-threatening or other significant sensitivity to any excipient
             of the study drugs.

          -  Female who is pregnant, planning to become pregnant during the study, or
             breastfeeding; or male whose partner is pregnant or planning to become pregnant during
             the study.

          -  Recent (within 6 months prior to study drug administration) history of drug or alcohol
             abuse that could preclude adherence to the protocol in the opinion of the
             investigator.

          -  Positive test result at Screening for hepatitis B surface antigen (HBsAg) or
             anti-human immunodeficiency virus antibody (HIV Ab).

          -  HCV genotype performed during screening indicating coinfection with more than 1 HCV
             genotype.
Pregabalin in the Treatment of Patients With Generalized Anxiety Disorder (GAD).
Condition: Generalized Anxiety Disorder
MeSH terms: Anxiety Disorders
Intervention: pregabalin; placebo
Intervention description: pregabalin 150-600 mg/day flexibly dosed for the first 6 weeks and fixed dosed for the last 2 weeks of total 8 weeks of double blind study period, + concurrent GAD treatment from the open-label study period; placebo + concurrent GAD treatment from the open-label study period
Intervention MeSH terms: Pregabalin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 356.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to evaluate the efficacy of pregabalin as compared to
      placebo in the treatment of patients with general anxiety disorder (GAD). Efficacy will be
      measured by the improvement in the total Hamilton Anxiety Rating Scale (HAM-A) scores from
      baseline observed following 8 weeks of double-blind treatment or at earlier termination
      during the double-blind treatment phase and analyzed using a mixed linear model for repeated
      measures.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult male and female subjects with primary DSM-IV diagnosis of GAD, as confirmed by
             the MINI structured interview.

          -  Historical failure to respond optimally to a GAD treatment

        Exclusion Criteria:

          -  Current primary DSM-IV (Diagnostic and Statistical Manual of Mental Disorders 4th
             edition) diagnosis of major depressive disorder with or without seasonal pattern,
             dysthmic disorder, depressive disorder NOS (not otherwise specified), social phobia,
             panic disorder with or without agoraphobia, post traumatic stress disorder,
             dissociative disorder, borderline personality disorder, obsessive-compulsive disorder,
             antisocial personality disorder, as defined in the DSM-IV TR (Diagnostic and
             Statistical Manual of Mental Disorders 4th edition, Text Revision).

          -  Past and/or current DSM-IV diagnosis of schizophrenia, schizoaffective disorder, other
             psychotic disorders, bipolar disorders (I or II), factitious disorder or cognitive
             disorder (including delirium, dementia, and amnestic disorder).
Tofacitinib In Psoriatic Arthritis Subjects With Inadequate Response to TNF Inhibitors
Condition: Psoriatic Arthritis
MeSH terms: Arthritis; Arthritis, Psoriatic
Intervention: Tofacitinib; Tofacitinib; Placebo; Tofacitinib; Placebo; Tofacitinib
Intervention description: tablets, 5 mg BID x 6 months; tablets, 10 mg BID x 6 months; tablets, to match tofacitinib 5 mg BID x 3 months; tablets, 5 mg BID x 3 months; tablets, to match tofacitinib 10 mg BID x 3 months; tablets, 10 mg BID x 3 months
Intervention MeSH terms: Tofacitinib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 395.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: psoriatic arthritis; tofacitinib; ACR20; HAQ-DI; TNF inhibitor failure

Summary:

      To examine the safety and efficacy of tofacitinib in subjects with active psoriatic arthritis
      who have previously had an inadequate response to at least one TNF inhibitor either due to
      lack of efficacy or an adverse event.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Active arthritis at screening/baseline as indicated by >/= 3 tender/painful and 3
             swollen joints

          -  Active plaque psoriasis at screening

          -  Inadequate efficacy or lack of toleration to previously administered TNF inhibitor

        Exclusion Criteria:

          -  Non-plaque forms of psoriasis (with exception of nail psoriasis)

          -  History of autoimmune rheumatic disease other than PsA; also prior history of or
             current, rheumatic inflammatory disease other than PsA
Developing World Study for RotaTeq™ (V260-015)(COMPLETED)
Condition: Vomiting; Diarrhea; Fever
MeSH terms: Vomiting; Diarrhea
Intervention: RotaTeq™ - Rotavirus Vaccine, Live, Oral, Pentavalent; Comparator: Placebo
Intervention description: 2.0 mL oral dose of RotaTeq™. 14 week treatment period; Arm 2: Placebo. 14 week treatment period
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 7504.0
Sex: All
Minimum age: 4 Weeks
Maximum age: 12 Weeks
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of the current study is to evaluate whether the vaccine is effective,
      well-tolerated and immunogenic among infants in developing countries.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 4 weeks through 12 weeks at Dose 1

          -  Parent able to understand study procedures and give consent

        Exclusion Criteria:

          -  Clinical evidence of active gastrointestinal disease

          -  Subjects who are currently or expected to participate in other studies of
             investigational products during the 6 weeks after receiving the last dose of
             RotaTeq™/placebo
Venlafaxine ER Long-Term Extension Study for Major Depressive Disorder (MDD)
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: Venlafaxine ER
Intervention description: Treatment phase: 10 months (75-225 mg/day), oral administration Tapering phase: 1-3 weeks (stepwise dose reduction: 150-37.5 mg/day), oral administration
Intervention MeSH terms: Venlafaxine Hydrochloride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Venlafaxine ER; long-term extension; Japan

Summary:

      This is a phase 3, flexible-dose, open-label, multi-center study. The subjects who complete
      the week 8 visit in the prior double-blind study (B2411263) will be eligible to participate
      in this study. This study consists of 10 month treatment phase and 1-3 week tapering phase.
      The 2 follow-up visits will be evaluated after 2 weeks and 4 weeks of last study medication
      dosing.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Outpatients who have completed 8 weeks double-blind study (B2411263), without major
             protocol violations or tolerability concerns in the opinion of the investigator.

        Exclusion Criteria:

          -  Clinically important abnormalities on baseline (Week 8 of the double-blind study)
             physical examination, or any unresolved clinically significant abnormalities on
             electrocardiogram (ECG), laboratory test results, or vital signs recorded before Week
             8 in the previous double-blind study.

          -  Significant risk of suicide based on clinical judgment.

          -  Use of prohibited treatments
A Comparison of Technegas and Xenon-133 Planar Lung Imaging in Subjects Referred for Ventilation Scintigraphy
Condition: Lung Structure Determination
Intervention: Xe-133; Technegas
Intervention description: Xe-133 ventilation scintigraphy; Technegas ventilation scintigraphy
Intervention MeSH terms: Xenon
Phase: Phase 3
Study type: Interventional
Primary purpose: Other
Intervention model: Crossover Assignment
Intervention model description: Subjects will undergo standard of care Xe-133 ventilation scintigraphy per medical needs followed by investigational Technegas ventilation scintigraphy per protocol.
Masking: None (Open Label)
Masking description: Independent blinded readers will assess all ventilation scintigraphy images, masked as to subject identity and re-identified with a unique random code number (different code numbers for Xe-133 and Technegas images). The Xe-133 and Technegas images will be read in separate reading sessions in random order.
Enrollment: 226.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: pulmonary ventilation; ventilation scintigraphy

Summary:

      Phase 3 within-subject non-inferiority trial of Technegas ventilation imaging compared to
      Xenon-133 (Xe-133) ventilation imaging to demonstrate the non-inferiority of Technegas
      compared to Xe-133 ventilation studies with respect to subject pulmonary ventilatory
      distribution. Subjects will undergo site-specific standard of care (SOC) Xe-133 imaging per
      medical needs followed by Technegas ventilation imaging per study protocol.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subject at least 18 years of age.

          -  Subject is a candidate for ventilation imaging.

          -  Subject must be willing and able to provide informed consent.

          -  Subject must be stable and able to undergo Xe-133 planar imaging and Technegas planar
             imaging.

          -  Subject must be willing and agree to complete study procedures.

          -  Subject is using adequate birth control, if female and fertile. Adequate birth control
             is defined as surgical sterilization, hormone contraceptive use or intrauterine device
             (IUD).

          -  Female subject of child-bearing potential has a negative urine or serum pregnancy
             test.

          -  Subject has had or is scheduled to have a chest X-ray within 24 hours prior to the
             investigational imaging study.

        Exclusion Criteria:

          -  Subject has been administered any other radiopharmaceutical within a timeframe that
             might cause interference with study imaging.

          -  Subject is a pregnant or lactating female.

          -  Subject has received Technegas in the past.

          -  Subject has received an investigational drug within 30 days prior to dosing.

          -  Subject is hemodynamically unstable.
Efficacy and Safety Study of Pregabalin in the Treatment of Pain on Walking in Patients With Diabetic Peripheral Neuropathy (DPN)
Condition: Diabetic Peripheral Neuropathy
MeSH terms: Peripheral Nervous System Diseases; Diabetic Neuropathies
Intervention: Pregabalin; placebo
Intervention description: 150-300 mg/day given in 3 divided doses as capsules; matching placebo capsules given in 3 divided doses
Intervention MeSH terms: Pregabalin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 217.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Diabetic Peripheral Neuropathy; Pain on Walking; Pregabalin

Summary:

      The intent of this study is to treat subjects with painful Diabetic Peripheral Neuropathy
      (DPN) who also have pain on walking and to determine whether or not pregabalin demonstrates
      improvement relative to placebo on the following: reducing DPN pain, reducing pain on
      walking, and providing other benefits associated with daily activities and quality of life.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men or women who are at least 18 years old.

          -  Diagnosis of painful diabetic peripheral neuropathy.

          -  Pain on walking.

        Exclusion Criteria:

          -  Inability to walk 50 feet on a flat surface.

          -  Pain on walking due to conditions other than diabetic peripheral neuropathy.