bioihbjkbjnl/mcl2 huggingface dataset:
Study to Assess the Efficacy and Safety of Ryanodex as Adjuvant Treatment in Subjects With EHS
Condition: Exertional Heat Stroke
MeSH terms: Heat Stroke; Sunstroke
Intervention: Ryanodex and Standard of Care; Standard of Care
Intervention description: Ryanodex to be administered as a rapid IV push; Body cooling measures and supportive measures
Intervention MeSH terms: Dantrolene
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Ryanodex (dantrolene sodium) for injectable suspension plus Standard of Care
Masking: Double (Participant, Care Provider)
Enrollment: 17.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No

Summary:

      A double-blind, parallel study of Ryanodex for the adjuvant treatment of exertional heat
      stroke (EHS) compared to current Standard of Care (SOC) for EHS.
    

Eligibility criteria:

        Inclusion Criteria: Core body temperature of greater than or equal to 40.0 degrees C (104
        degrees F); recent history of exertional activity; GCS score less than 13; tachycardia -

        Exclusion Criteria: clinical severe infection; hyperthermia secondary to another condition;
        endotracheal intubation;; sedative drugs administered prior to or at time of study entry;
        likelihood of head trauma within 6 months pre-study; positive pregnancy test; history of
        myocardial infection within 30 days; history of seizure disorder or epilepsy; concomitant
        or prior use of calcium channel blockers.

        -
A Comparative Study in Chinese Subjects With Chemotherapy Naïve Stage IV Melanoma Receiving Ipilimumab (3 mg/kg) vs. Dacarbazine
Condition: Melanoma
MeSH terms: Melanoma
Intervention: Ipilimumab; Dacarbazine
Intervention MeSH terms: Ipilimumab; Dacarbazine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 182.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether Ipilimumab will extend the life of chinese
      patients with Chemotherapy Naive Stage IV Melanoma more than Dacarbazine as well as to
      examine safety in this patient population.
    

Eligibility criteria:

        For more information regarding BMS clinical trial participation, please visit
        www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Chinese males and females ≥ 18 years of age

          -  Histologic diagnosis of malignant melanoma

          -  Chemotherapy naive Stage IV melanoma (AJCC 2010)

          -  Life expectancy of ≥ 16 weeks

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

        Exclusion Criteria:

          -  Evidence of brain metastases on brain imaging

          -  Primary ocular or mucosal melanoma

          -  Any other malignancy from which the patient has been disease-free for less than 5
             years

          -  BRAF status cannot be determined by Screening test

          -  Human Immunodeficiency Virus (HIV) positive or hepatitis B surface antigen (HBsAg)
             positive, or active Hepatitis C infection
Comparing Two Forms of Head Immobilization for Stereotactic Radiotherapy
Condition: Patients Receiving Fractionated Stereotactic Radiotherapy; for Brain Tumors
MeSH terms: Brain Neoplasms
Intervention: GTC frame; Thermoplastic facemask; Stereotactic radiation therapy
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 83.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Stereotactic radiotherapy

Summary:

      Fractionated stereotactic radiotherapy (SRT) requires extremely precise and reproducible
      immobilization of the patient's head. This randomized study compares the efficacy of two
      commonly used forms of immobilization used for SRT.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who are eligible for fractionated stereotactic radiotherapy

        Exclusion Criteria:

          -  Severe claustrophobia
Safety and Efficacy Study of Repeated Doses of DX-88 (Ecallantide) to Treat Attacks of Hereditary Angioedema (HAE)
Condition: Hereditary Angioedema (HAE)
MeSH terms: Angioedema; Angioedemas, Hereditary
Intervention: ecallantide
Intervention description: solution for SC injection, one 30 mg dose per HAE attack
Intervention MeSH terms: Ecallantide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 147.0
Sex: All
Minimum age: 10 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the efficacy and safety of repeated doses of
      ecallantide in the treatment of acute attacks of hereditary angioedema and to allow HAE
      patients continued access to ecallantide. In addition, patients enrolled in DX-88/20 (EDEMA4)
      trial will be followed up and treated for subsequent attacks in this trial.
    

Eligibility criteria:

        Inclusion Criteria:

          -  10 years of age or older

          -  Documented diagnosis of HAE (Type I or II)

          -  Willing and able to give informed consent

          -  Acute HAE attack at time of presentation

        Exclusion Criteria:

          -  Receipt of an investigational drug or device, within 30 days prior to study treatment,
             other than DX-88 (ecallantide)

          -  Pregnancy or breastfeeding

          -  Receipt of non-investigational C1-INH or DX-88 within 72 hours of treatment

          -  Patients eligible for current, ongoing clinical trial in which DX 88 (ecallantide) is
             offered
A Study to Test the Safety and Efficacy of Adding Sitagliptin in Patients With Type 2 Diabetes Mellitus (MK0431-074)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Comparator: Sitagliptin phosphate; Comparator: Placebo
Intervention description: All participants will receive placebo tablets two weeks prior to treatment period. Participants will receive sitagliptin phosphate 100 mg tablets once daily (q.d.) and continue on stable dose of metformin therapy (500 or 850 mg twice daily). Treatment period of 24 weeks.; All participants will receive placebo tablets two weeks prior to treatment period. Participants will receive sitagliptin phosphate placebo tablets q.d. and continue on stable dose of metformin therapy (500 or 850 mg twice daily). Treatment period of 24 weeks.
Intervention MeSH terms: Sitagliptin Phosphate; Metformin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 395.0
Sex: All
Minimum age: 18 Years
Maximum age: 78 Years
Healthy volunteers: No

Summary:

      A study to assess the safety and efficacy of the addition of sitagliptin compared to placebo
      in patients with Type 2 Diabetes Mellitus who have inadequate glycemic control on metformin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 - 78 years of age

          -  Currently on metformin monotherapy

        Exclusion Criteria:

          -  History of Type 1 diabetes mellitus or ketoacidosis

          -  Currently on a weight loss program and not in the maintenance phase or has started on
             a weight loss medication within the last 8 weeks

          -  Has undergone surgery requiring general anesthesia within the past 4 weeks or has
             planned major surgery

          -  Currently participating in a study or has participated in a study with or without an
             investigational compound or device within the past 12 weeks

          -  History of active liver disease such as chronic active hepatitis B or C, cirrhosis or
             symptomatic gallbladder disease

          -  HIV positive

          -  Pregnant, breast-feeding or planning to become pregnant during the study

          -  User of recreational or illicit drugs or has a recent history (within the past year)
             of drug or alcohol abuse or dependence
Long-Term Follow-Up Studies at Year 6, 7, 8, 9, 10: 2 Formulations of Combined Hepatitis A/B Vaccine Compared in Subjects Aged 12-15 Years
Condition: Hepatitis B; Hepatitis A
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis
Intervention: Twinrix™ Adult; Twinrix™ Junior
Intervention description: Intramuscular administration in the deltoid region (2 doses).; Intramuscular administration in the deltoid region (3 doses).
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 244.0
Sex: All
Minimum age: 12 Years
Maximum age: 15 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Hepatitis B; TWINRIX™ Adult; Hepatitis A; TWINRIX™ Junior

Summary:

      To evaluate the persistence of anti-hepatitis A virus (anti-HAV) and anti-hepatitis B surface
      antigen (anti-HBs) antibodies up to 6, 7, 8, 9 and 10 years after administration of the first
      dose of the study vaccine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy male and female volunteers vaccinated in study HAB-084.

          -  Written informed consent obtained from the subject before the blood sampling visit of
             each year.

        Exclusion Criteria:

        • none
Effectiveness of D-Cycloserine as an Aid to Enhance Learning for Individuals With OCD Receiving Behavior Therapy
Condition: Obsessive-Compulsive Disorder
MeSH terms: Obsessive-Compulsive Disorder
Intervention: seromycin; Behavior Therapy
Intervention description: 100mg tablet administered 1 hour prior to each therapy session; 10 weekly hour-long behavior therapy sessions
Intervention MeSH terms: Cycloserine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 33.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: OCD

Summary:

      This study will assess the effectiveness of Seromycin (D-cycloserine) in enhancing the
      positive effects of behavior therapy for people with Obsessive-Compulsive Disorder (OCD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Structured Clinical Interview for DSM-IV (SCID) diagnosis of Obsessive Compulsive
             Disorder

          -  Score of greater than 16 on the Yale-Brown Obsessive Compulsive Scale

          -  Negative urinary beta-Human Chorionic Gonadotropin (hCG) test

        Exclusion Criteria:

          -  Currently taking or have taken an unstable dose of psychotropic medications within 2
             months prior to enrollment

          -  Currently taking medications that may interfere with the study medication

          -  History of seizure disorder or other serious medical illnesses (e.g., cardiovascular,
             liver, kidney, respiratory, endocrine, neurologic, or blood-related disease)

          -  Current diagnosis of tuberculosis

          -  Other psychiatric diagnoses (e.g., alcohol dependence, bipolar disorder, psychosis,
             organic mental disorder, or development disorder) that are of greater concern than the
             obsessive-compulsive disorder diagnosis

          -  Currently taking medications that may lower seizure threshold (e.g., including
             clozapine, pethidine, and the following antibiotics in high dosage: penicillins,
             cephalosporins, amphotericin, and imipenem)

          -  Poses a serious suicidal or homicidal threat

          -  Currently undergoing psychotherapy

          -  Failure to benefit from ten or more sessions of previous Exposure and Response
             Prevention (ERP) treatment

          -  Pregnant or breastfeeding
Clinical Study of TA-650 in Patients With Refractory Kawasaki Disease
Condition: Kawasaki Disease Refractory to Initial Therapy With Intravenous Immunoglobulin
MeSH terms: Mucocutaneous Lymph Node Syndrome
Intervention: TA-650; Polyethylene Glycol-treated Human Immunoglobulin (VGIH)
Intervention description: TA-650 at 5 mg per kg body weight on the day of TA-650 administration (day 0) is administered by intravenous infusion slowly over at least 2 hours.; VGIH at 2 g per kg body weight on the day of VGIH administration (day 0) is administered by intravenous infusion slowly over at least 20 hours.
Intervention MeSH terms: Immunoglobulins; Immunoglobulins, Intravenous; Antibodies
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 31.0
Sex: All
Minimum age: 1 Year
Maximum age: 10 Years
Healthy volunteers: No
Keywords: Infliximab; REMICADE; TA-650; intravenous immunoglobulin; Kawasaki disease; IVIG

Summary:

      The purpose of this study is to evaluate the efficacy and safety of TA-650 in comparison with
      a control drug Polyethylene Glycol-treated Human Immunoglobulin (VGIH) in patients with
      Kawasaki disease refractory to initial therapy with Intravenous Immunoglobulin (IVIG). The
      pharmacokinetics of TA-650 is also examined.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients diagnosed with Kawasaki disease (incipient cases only) with 5 or more of the
             6 major symptoms of Kawasaki disease.

          -  Patients refractory to initial IVIG therapy (a single administration at 2 g per kg
             body weight).

          -  Patients with a fever of 37.5ºC or higher axillary temperature at the time of
             enrollment.

          -  Patients to whom the study drug can be administered by day 8 of disease.

        Exclusion Criteria:

          -  Patients who have received vaccination with Bacille Calmette-Guérin (BCG) vaccine
             within 6 months before the enrollment.

          -  Patients with a complication, or a history within 6 months before the enrollment of,
             serious infections requiring hospitalization.

          -  Patients with a complication, or a history within 6 months before the enrollment of,
             opportunistic infections.

          -  Patients complicated with active tuberculosis, active hepatitis B or C, or patients
             confirmed to be hepatitis B virus carriers or a history of hepatitis B.

          -  Patients confirmed to have HIV infection, or patients with a family history of HIV
             infection.

          -  Patients who have a history of receiving treatment with infliximab or other biological
             products.

          -  Patients who had participated in another clinical study and had received a study drug
             within 12 weeks before giving consent.
Induction With Misoprostol: Oral Mucosa Versus Vaginal Epithelium (IMPROVE)
Condition: Pregnancy
Intervention: misoprostol/placebo
Intervention description: buccal or vaginal routes of administration/ placebo to compare methods for efficacy and safety during induction.
Intervention MeSH terms: Misoprostol
Phase: Phase 3
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 300.0
Sex: Female
Minimum age: 14 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: induction of labor; safety; pharmacokinetic; misoprostol

Summary:

      The primary objective of this study is to compare the efficacy and safety of vaginal and
      buccal misoprostol for women undergoing labor induction at greater than or equal to 37+ 0
      completed weeks gestation. Thus, the investigators have both efficacy and a safety primary
      outcomes.

      The secondary objective of this study is to assess the pharmacokinetic(PK) parameters with
      these two routes of administration in a sub-cohort of this trial. The long term objective of
      this line of research is to inform providers' clinical decision making for the large number
      of women having labor induction. By providing robust PK and pharmacodynamic (PD) evaluation,
      clinical outcomes data for these two routes of administration, clinicians will be informed
      for evidence-based decisions about the preferred route of administration of misoprostol.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A medical indication for induction of labor at a gestational age between 37 +0 and 38
             +6 weeks OR an elective or medical indication for induction of labor at a gestational
             age greater than or equal to 39 + 0 completed weeks

          -  Participant age of greater than or equal to14 years old

          -  Singleton pregnancy

          -  Modified Bishop score of less than or equal to 6

          -  Vertex fetal presentation by examination or ultrasound

          -  Any membrane status

        Exclusion Criteria:

          -  Elective inductions between 37 +0 and 38 +6 completed weeks are specifically excluded

          -  Known intrauterine fetal demise

          -  Any uterine scar including prior cesarean section and myomectomy

          -  Known major fetal congenital malformations that may impact neonatal health

          -  Other evidence of fetal compromise (such as Category 2 or 3 tracing) before the
             induction begins

          -  Prior induction/cervical ripening methods utilized during this pregnancy

          -  Allergy to misoprostol

          -  Known untreated cervical infection (e.g. Gonorrhea, Chlamydia)

          -  Planned cesarean section due to maternal or fetal condition

          -  Any other contraindication to labor induction or misoprostol therapy
Prevalence of Vitamin D Deficiency in Type 1 Diabetes Mellitus and Effect of Supplementation on Insulin Requirements
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1; Vitamin D Deficiency
Intervention: Vitamin D
Intervention description: 2000iu once a day
Intervention MeSH terms: Vitamin D; Cholecalciferol
Phase: Phase 3
Study type: Interventional
Primary purpose: Health Services Research
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients with clinically significantly low Vitamin D levels (<30 ng/mL) were supplemented with Vitamin D and compared to patients with normal vitamin D levels (50-80 nG/mL).
Masking: None (Open Label)
Enrollment: 75.0
Sex: All
Minimum age: 1 Year
Maximum age: 18 Years
Healthy volunteers: No
Keywords: Diabetes; Type I; Newly Diagnosis Type I Diabetes Mellitus

Summary:

      Our objective is to demonstrate that providing supplemental vitamin D to children with new
      onset DM will significantly decrease the levels of HbA1c and insulin requirement by the
      following methods.

        1. Identify how often vitamin D levels are low in patients with new onset Type 1 diabetes
           mellitus (DM).

        2. Record the hemoglobin A1c (HbA1c) level (which reflects the average blood sugar level
           over the past few months) and document insulin requirements before and after vitamin
           supplementation is given.

      Hypothesis: Maintaining vitamin D levels >30 ng/ml will decrease HbA1c and insulin
      requirements.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Newly diagnosed type I DM.

          -  Age <18 years

        Exclusion Criteria:

          -  Pregnancy
Isoflurane-induced Neuroinflammation in Children With Hydrocephalus
Condition: Toxicity; Hydrocephalus
MeSH terms: Hydrocephalus; Neuroinflammatory Diseases
Intervention: Isoflurane; Dexmedetomidine
Intervention MeSH terms: Dexmedetomidine; Isoflurane
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 1 Day
Maximum age: 5 Years
Healthy volunteers: No

Summary:

      The investigators will quantify inflammatory biomarkers in cerebrospinal fluid (CSF) and
      serum of children with hydrocephalus who are undergoing ventriculoperitoneal shunt placement
      under isoflurane anesthesia.
    

Eligibility criteria:

        Inclusion Criteria (HC study patients):

          -  Pediatric patients, aged 6 months-less than 11 years, diagnosed with hydrocephalus
             undergoing a primary surgical (non-bedside) shunting procedure with general
             anesthesia.

          -  Participants must have a parent/guardian who is able to provide written informed
             consent in accordance with human investigation committee guidelines.

          -  The shunting procedure must be an initial VPS placement (not a VPS revision).

        Inclusion Criteria (MRI with general anesthesia: peripheral blood patients; anesthesia but
        no surgery):

          -  Otherwise healthy pediatric patients, aged 6 months-less than 11 years, undergoing MRI
             with general anesthesia for evaluation of non-neurologic, non-inflammatory disease.

          -  Participants must have a parent/guardian who is able to provide written informed
             consent in accordance with IRB guidelines.

        Exclusion Criteria (HC study patients):

          -  Any active infection or infection within the last 14 days.

          -  Treatment in the last 48 hours with non-steroidal anti-inflammatory (NSAID) or
             corticosteroid medications.

          -  Anticoagulant administration in the last 48 hours.

          -  Treatment with any drug known to induce or suppress inflammation.

          -  Clinically unstable patients.

          -  Patients that have an American Society of Anesthesiologists physical status ≥4
             (severe, life-threatening disease).

          -  Infants born more than 4 weeks premature.

        Exclusion Criteria (MRI with general anesthesia: peripheral blood patients; anesthesia but
        no surgery):

          -  Known central nervous system disease.

          -  Treatment in the last 48 hours with non-steroidal anti-inflammatory (NSAID) or
             corticosteroid medications.

          -  Treatment with any drug known to induce or suppress inflammation.

          -  Patients that have an American Society of Anesthesiologists (ASA) physical status ≥4
             (severe, life-threatening disease).

          -  Infants born more than 4 weeks premature.