bioihbjkbjnl/mcl2 huggingface dataset:
A Pharmacokinetic Study of a Single-Dose of Diazepam Nasal Spray in Adult Epileptic Patients Experiencing a Seizure Episode
Condition: Epilepsy
MeSH terms: Seizures
Intervention: Diazepam
Intervention description: single-dose; dosage in mg, based on patient body weight
Intervention MeSH terms: Diazepam
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 31.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine the pharmacokinetics of Diazepam Nasal Spray
      following a single dose in epileptic patients experiencing a seizure episode.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provide signed informed consent for study participation.

          -  General good health with no clinically significant unstable abnormalities.

          -  Diagnosis of epilepsy.

        Exclusion Criteria:

          -  Individuals receiving warfarin (Coumadin®) or dabigatran (Pradaxa®).

          -  Use of any investigational drug within 30 days.

          -  Blood or plasma donation within 30 days.

          -  Not willing or unable to tolerate blood draws.
Arasertaconazole Nitrate Pessaries - Dose Finding Study for the Vulvovaginal Candidiasis (VVC) Treatment
Condition: Vulvovaginal Candidiasis
MeSH terms: Candidiasis; Candidiasis, Vulvovaginal
Intervention: arasertaconazole nitrate; placebo
Intervention description: Arasertaconazole nitrate pessary, placebo pessary; placebo, single dose
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 229.0
Sex: Female
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: VVC; candidiasis; vaginal candidiasis

Summary:

      In order to find an optimal dose of arasertaconazole nitrate in the treatment of vulvovaginal
      candidiasis, a multicenter, randomized, double-blind, parallel, placebo-controlled study will
      be conducted to compare the therapeutic efficacy, safety and tolerability of three different
      doses of arasertaconazole nitrate (150 mg, 300 mg or 600 mg, pessaries).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women aged between 18 to 65 years of age who have signed the informed consent.

          -  Not pregnant, not nursing.

          -  No indication of other vulvovaginitis or genital infections

          -  Positive 10% potassium hydroxide (KOH) preparation for budding yeast and/or
             pseudohyphae.

          -  Negative wet mount results for T. vaginalis and clue cells.

          -  Exclusion Criteria:

          -  Subjects with another vaginal or vulvar condition that would confound the
             interpretation of clinical response.

          -  Hypersensitivity to imidazole products administered topically.

          -  Any other medical condition which in the opinion of the investigator could interfere
             with study conduct.
A Study to Evaluate RIST4721 in Palmoplantar Pustulosis (PPP)
Condition: Palmoplantar Pustulosis
MeSH terms: Psoriasis
Intervention: RIST4721; Placebo
Intervention description: RIST4721 oral solution; Placebo oral solution
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking description: Double-blind
Enrollment: 35.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: PPP

Summary:

      A Randomized, Double-Blind, Placebo-Controlled, Phase 2a Study to Evaluate the Efficacy and
      Safety of RIST4721 in Subjects with Palmoplantar Pustulosis
    

Eligibility criteria:

        Inclusion Criteria:

          -  At least a 6-month history of PPP as defined by the presence of pustules on palms
             and/or soles, but without evidence of infection on palms and soles

          -  Moderate or severe PPP, as defined by Palmoplantar Pustulosis Psoriasis Area and
             Severity Index (PPPASI) ≥8 and Palmoplantar Pustulosis Physician Global Assessment
             (PPPGA) ≥3 at Day -1, and a minimum of 8 fresh pustules at screening (fresh pustule
             count on both right/left palms and soles) and 20 fresh pustules at Day -1 (fresh
             pustule count on both right/left palms and soles)

          -  Males and females must be willing to use birth control as indicated

        Exclusion Criteria:

          -  Moderate to severe psoriasis, as defined by plaque psoriasis covering ≥10% of total
             Body Surface Area (BSA) at Day -1

          -  Subject is known to have an immune deficiency or is immunocompromised

          -  Positive test for hepatitis, human immunodeficiency virus (HIV) or tuberculosis

          -  Use of topical therapies for PPP within 2 weeks of Day -1 and/or systemic therapies
             for PPP within 4 weeks
Safety and Efficacy Trial of Ipilimumab Versus Pemetrexed in Non-Squamous Non-Small Cell Lung Cancer
Condition: Lung Cancer - Non Small Cell
MeSH terms: Lung Neoplasms
Intervention: Ipilimumab; Pemetrexed
Intervention description: Intravenous (IV) solution, IV, 10mg/kg, Once every 3 weeks for 4 doses, then once every 12 weeks during Treatment Phase, 90 minute infusion; IV solution, IV, 500 mg/m2, Once every 3 weeks during Treatment Phase, 10 minute infusion.
Intervention MeSH terms: Pemetrexed; Ipilimumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this trial is to determine whether Ipilimumab will prolong survival when
      compared to Pemetrexed in subjects with nonsquamous, non-small cell lung cancer.
    

Eligibility criteria:

        For additional information, please contact the BMS oncology clinical trial information
        service at 855-216-0126 or email MyCancerStudyConnect@emergingmed.com. Please visit
        www.BMSStudyConnect.com for more information on clinical trial participation.

        Inclusion Criteria:

          -  Non-Squamous, Non-Small Cell Lung Cancer

          -  Recurrent/Stage IV Non-small cell lung cancer (NSCLC)

          -  Eastern Cooperative Oncology Group (ECOG) 0 or 1

          -  Not progressing after 4 cycles of a platinum-based first line chemotherapy

        Exclusion Criteria:

          -  Brain Metastases (unless stable)

          -  Autoimmune Diseases
A Phase 2 Study of LY2495655 in Participants With Pancreatic Cancer
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Intervention: LY2495655; Placebo; Standard of Care Chemotherapy
Intervention description: Intravenous (IV) treatment every 14 days while on study. Number of Cycles: until treatment options are exhausted or unacceptable toxicity develops.; Intravenous (IV) treatment every 14 days while on study. Number of Cycles: until treatment options are exhausted or unacceptable toxicity develops.; Standard of care, gemcitabine-based regimen (single-agent gemcitabine or gemcitabine plus erlotinib) or FOLFIRINOX (combination chemotherapy regimen including 5-fluorouracil, leucovorin, oxaliplatin, and irinotecan). The choice of gemcitabine-based regimen or FOLFIRINOX will be determined by the investigator (based on the standard of care used at the treating institution or as directed by local regulatory authorities).
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 125.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase 2 study is a multicenter, randomized, double-blind, placebo-controlled trial in
      participants with locally advanced/inoperable or metastatic pancreatic cancer, and will
      investigate 2 different doses of LY2495655 in combination with standard of care chemotherapy.
    

Eligibility criteria:

        Inclusion:

          -  Unresectable or metastatic pancreas cancer; participants with previous radical surgery
             for pancreas cancer are eligible after progression is documented

          -  Participants may have received previous adjuvant treatment with gemcitabine with or
             without radiotherapy for pancreas cancer

          -  ECOG (Eastern Cooperative Oncology Group) Performance status ≤ 2

          -  Adequate organ function

          -  Have an estimated life expectancy of at least 12 weeks and in the judgment of the
             investigator, will be able to complete at least 2 cycles of treatment

          -  Ability to perform the indicated functional performance measures at baseline

        Exclusion:

          -  Prior systemic therapy for unresectable/metastatic pancreas cancer

          -  Any medical or psychiatric condition, orthopedic or neuromuscular conditions that
             could limit participation or confound study results

          -  Currently taking medications that are considered both muscle building and performance
             enhancing (for example, androgen therapies, or anabolic steroids)
Repeated Partial Sleep Deprivation to Augment SSRI Response in Depression
Condition: Depression
MeSH terms: Sleep Deprivation; Depression; Depressive Disorder
Intervention: Sleep scheduling; Fluoxetine
Intervention description: 8 hours vs. 6 hours time in bed for two weeks, with either 2 hour advance of risetime, or 2 hour delay of bedtime; 20-40 mg fluoxetine daily for 8 weeks
Intervention MeSH terms: Fluoxetine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 68.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: depression; sleep; treatment

Summary:

      The purpose of the study is to determine whether changing sleep patterns improves response to
      an antidepressant medication.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Between 18 and 65 years old

          -  Current major depressive episode

          -  Habitual TIB of 7 to < 10 hours

          -  No antidepressant medications for ≥ 2 weeks (4 weeks for MAOIs or longer acting
             antidepressants)

          -  Score of at least 18 on the Hamilton Rating Scale of Depression

        Exclusion Criteria:

          -  Alcohol or substance abuse/dependence in past 6 months

          -  Current posttraumatic stress disorder or bulimia nervosa (past 6 months)

          -  Lifetime history of bipolar I or II disorder, schizophrenia/other psychotic disorder,
             and anorexia nervosa

          -  Trials of fluoxetine in the past 6 months

          -  Medical disorders or pain syndromes that may affect sleep or are associated with
             significant depression (e.g. thyroid or Cushing's disease); history of head trauma
             with loss of consciousness of > 5 minutes; history of seizures

          -  Sleep disorders other than insomnia, such as sleep apnea and periodic limb movement
             disorder

          -  Current use of prescription, over-the-counter, or naturopathic remedies for sleep
             (e.g., barbiturates, benzodiazepine agonists, nonbenzodiazepine hypnotics, analgesics)
             or depression (e.g., Sam-E, St. John's Wort)

          -  Currently working evening or midnight shift (subjects who have recently traveled
             across multiple time zones will be included at the discretion of the PI).

          -  Currently at risk for drowsy driving or employment that requires routine operation of
             transportation vehicles (e.g., truck/taxi driver, airline pilot) or hazardous
             equipment.

          -  Known allergy, hypersensitivity or contraindication to study medication

          -  Females: pregnant or nursing
A Study of HTD1801 in Adults With Nonalcoholic Steatohepatitis (NASH) and Type 2 Diabetes Mellitus (T2DM)
Condition: Fatty Liver, Nonalcoholic; NAFLD; Nonalcoholic Fatty Liver Disease; Nonalcoholic Steatohepatitis; Digestive System Diseases; Type 2 Diabetes Mellitus (T2DM)
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease; Digestive System Diseases; Gastrointestinal Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: HTD1801; Placebo
Intervention description: HTD1801 tablets, 250mg; tablets manufactured to mimic HTD1801 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: 101.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      Randomized, double-blind, placebo-controlled, parallel-group study comparing multiple doses
      of HTD1801 to placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of NASH as assessed by MRI

          -  Clinically documented diagnosis of T2DM

          -  Body mass index (BMI) >25 kg/m2

        Exclusion Criteria:

          -  Liver disease unrelated to NASH

          -  Poorly controlled T2DM or Type 1 Diabetes Mellitus

          -  History of alcohol or substance abuse or dependence

          -  Inability to undergo MRI for any reason

          -  History of significant cardiovascular disease
A Study to Explore the Impact of Lumacaftor/Ivacaftor on Disease Progression in Subjects Aged 2 Through 5 Years With Cystic Fibrosis, Homozygous for F508del
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis; Disease Progression
Intervention: LUM/IVA; LUM/IVA; Placebo
Intervention description: FDC tablets or granules for oral administration.; FDC granules for oral administration.; Placebo matched to LUM/IVA for oral administration.
Intervention MeSH terms: Ivacaftor
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Double blinded in Part 1, and Open label in Part 2
Enrollment: 51.0
Sex: All
Minimum age: 2 Years
Maximum age: 5 Years
Healthy volunteers: No

Summary:

      This study will explore the impact of lumacaftor/ivacaftor (LUM/IVA) on disease progression
      in subjects aged 2 through 5 years with cystic fibrosis (CF), homozygous for F508del (F/F).
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Subjects with confirmed diagnosis of CF.

          -  Homozygous for F508del (F/F).

          -  Subjects who weigh ≥8 kg without shoes and wearing light clothing at the Screening
             Visit.

        Key Exclusion Criteria:

          -  Any clinically significant laboratory abnormalities at the Screening Visit that would
             interfere with the study assessments or pose an undue risk for the subject.

          -  Solid organ or hematological transplantation.

          -  History of any illness or comorbidity reviewed at the Screening Visit that, in the
             opinion of the investigator, might confound the results of the study.

        Other protocol defined Inclusion/Exclusion criteria may apply.
A Study Comparing Two Different PROCRIT Doses to a Dose of ARANESP in Anemic Cancer Patients Receiving Chemotherapy
Condition: Neoplasms; Anemia; Cancer
MeSH terms: Anemia
Intervention: epoetin alfa; darbepoetin alfa
Intervention description: 80,000 Units and 120,000 Units of epoetin alfa (PROCRIT) injected subcutaneously once every 3 weeks for up to 13 weeks; 500 mcg of darbepoetin alfa (ARANESP) injected subcutaneously the skin once every 3 weeks for up to 13 weeks
Intervention MeSH terms: Epoetin Alfa; Darbepoetin alfa
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 235.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Anemia; Cancer; Chemotherapy-Induced Anemia; Epoetin alfa; Darbepoetin alfa

Summary:

      The purpose of this study is to compare hemoglobin response rates between two PROCRIT
      (epoetin alfa) doses and ARANESP (darbepoetin alfa) in anemic cancer patients receiving
      chemotherapy
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed diagnosis of a non-myeloid malignancy

          -  Baseline hemoglobin (Hb) value of <= 11.0 g/dL unrelated to transfusion

          -  No Packed Red Blood Cell (PRBC) or platelet transfusions in the 28 days prior to
             randomization

          -  Scheduled to receive chemotherapy for a minimum of 12 weeks during the study

          -  Eastern Cooperative Oncology Group (ECOG) Performance Status 0 - 2

        Exclusion Criteria:

          -  No planned non-palliative radiation during the study

          -  No current anemia due to factors other than cancer/chemotherapy (eg, iron deficiency
             or gastrointestinal bleeding)

          -  No uncontrolled hypertension (defined as systolic pressure > 180 and/or a diastolic
             pressure > 100 mmHg while receiving antihypertension therapy)

          -  No history of Deep Venous Thrombosis (DVT) or Pulmonary Embolus (PE) within 12 months
             before study enrollment. Prior superficial thrombophlebitis is not an exclusion
             criterion

          -  No history of Cerebrovascular Accident (CVA), Transient Ischemic Attack (TIA), Acute
             Coronary Syndrome (ACS) including unstable angina and myocardial infarction with or
             without ST elevation, or other arterial thrombosis within 6 months before study
             enrollment
Effects of Tadalafil Once a Day for 12 Weeks in Men With Signs and Symptoms of Benign Prostatic Hyperplasia
Condition: Benign Prostatic Hyperplasia
MeSH terms: Prostatic Hyperplasia; Hyperplasia
Intervention: Tadalafil; Placebo
Intervention description: 20 mg tadalafil tablet taken by mouth once a day for 12 weeks.; Placebo tablet taken by mouth once a day for 12 weeks.
Intervention MeSH terms: Tadalafil
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 200.0
Sex: Male
Minimum age: 40 Years
Healthy volunteers: No
Keywords: Benign Prostatic Hyperplasia; Benign Prostatic Hypertrophy

Summary:

      The purpose of this study is to evaluate the function of the bladder and urethra during
      urinary storage or voiding in men with signs and symptoms of benign prostatic hyperplasia
      treated with either placebo or tadalafil.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men 40 years of age or older with Lower Urinary Tract Symptoms (LUTS) with a total
             International Prostate Symptom Score (IPSS) greater than or equal to 13 at Visit 1.

          -  Agree not to use any other approved or experimental medications for Benign Prostate
             Hyperplasia (BPH)-Lower Urinary Tract Symptoms, including alpha blockers, 5-alpha
             reductase inhibitors, PDE5 inhibitors, or herbal preparations at any time during the
             study.

          -  Have not taken finasteride or dutasteride therapy for at least 4 months prior to Visit
             2; have not taken any other LUTS therapy (including herbal preparations) or PDE5
             inhibitors for at least 4 weeks prior to Visit 2.

          -  Have had BPH-LUTS for greater than 6 months prior to Visit 1.

        Exclusion Criteria:

          -  Any pelvic surgical procedure on the urinary tract, including minimally invasive
             BPH-LUTS therapies and penile implant surgery.

          -  History of urethral obstruction due to stricture, valves, sclerosis, or tumor.

          -  Current neurologic disease or condition associated with neurogenic bladder (for
             example, Parkinson's disease, multiple sclerosis).

          -  History of cardiac conditions including myocardial infarction, bypass surgery,
             angioplasty or stent placement for a specified time before starting the study.

          -  History of angina requiring treatment with nitrates.

          -  Prostate Specific Antigen (PSA) greater than 10 nanogram/milliliter (ng/ml) at Visit
             1.
TAK-954 in Critically Ill Participants With Enteral Feeding Intolerance (EFI)
Condition: Critical Illness; Enteral Nutrition; Enteral Feeding Intolerance
MeSH terms: Critical Illness
Intervention: TAK-954; Metoclopramide; Normal Saline
Intervention description: TAK-954 infusion; Metoclopramide infusion; 0.9% sodium chloride for injection
Intervention MeSH terms: Metoclopramide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Drug therapy

Summary:

      The purpose of this study is to assess the treatment effect of intravenous TAK-954 in
      improving the average daily protein adequacy received through enteral nutrition in
      critically-ill participants developing EFI.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Has at least a size 12-(french size) Fr nasogastric or orogastric tube with its tip at
             least 10 centimeter (cm) below the esophagogastric junction confirmed radiologically
             (the tip of the tube must be in the body or the antrum of the stomach and not in the
             fundus).

          2. Is intubated and mechanically ventilated in the ICU.

          3. Is expected to remain alive, mechanically ventilated, and receive continuous enteral
             feeding for >=48 hours following randomization.

          4. Have EFI, defined as a single GRV measurement of >=250 mL with vomiting/retching
             within the last 24 hours, or a single GRV measurement of >=500 mL with or without
             vomiting/retching within the last 24 hours.

        Exclusion Criteria:

          1. Is under consideration for withdrawal of life-sustaining treatments within the next 72
             hours.

          2. Has had major esophageal or gastric surgery or direct luminal trauma on this admission
             (participants with lower abdominal surgery are not excluded unless enteral feeding is
             contraindicated).

          3. Has mechanical bowel obstruction, short bowel syndrome, or the presence of an active
             gastric pacemaker.

          4. Have pre-existing hepatic disease that meets Child-Pugh Class B (moderate; total score
             7 to 9 points) or C (severe; total score 10 to 15 points).

          5. Has been admitted primarily for treatment of a drug overdose.

          6. Has a presence of a post-pyloric tube in place at Randomization that may be used for
             enteral nutrition.

          7. Is receiving parenteral nutrition (PN) at Screening.

          8. Is in diabetic ketoacidosis or non-ketotic hyperosmolar coma.

          9. Has a different nutrient requirement than allowed in feeding protocol.(outside a range
             of 1.2 to 2 gram per kilogram per day [g/kg/day] of proteins and up to 1.5 kilocalorie
             per milliliter [kcal/mL]).