bioihbjkbjnl/mcl2 huggingface dataset:
Single Blind Cross-over Dose Response Study in Subjects of Two Inhalers of Salmeterol and Fluticasone Propionate
Condition: Healthy
Intervention: Salmeterol; fluticasone propionate
Intervention description: A, D 2 puffs; B, E 6 puffs; C, F 12 puffs; A, D 2 puffs; B, E 6 puffs; C, F 12 puffs
Intervention MeSH terms: Fluticasone; Xhance; Salmeterol Xinafoate; Fluticasone-Salmeterol Drug Combination
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 52.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: long-acting beta agonist (LABA); corticosteroid; pMDI; inhaler

Summary:

      The purpose of this study is to test the body's response to several doses of two different
      inhalation products in healthy volunteers.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy Volunteer

          -  Willing and able to give informed consent

          -  Willing to withhold all alcoholic beverages for 48 hours and all xanthine- containing
             foods and beverages for 24 hours prior to reporting to clinic

          -  Male and female subjects aged 18 to 55 years (inclusive)

          -  Subjects must agree to use an adequate method of contraception from admission through
             12 weeks after last administration

        Exclusion Criteria:

          -  Evidence or history of clinically significant abnormalities or disease or chronic
             respiratory disorders

          -  Any presence or history of a clinically significant allergy including any adverse
             reaction to study drug

          -  History of drug or alcohol abuse within the past 2 years

          -  Smoked tobacco within the past 6 months or have a history of more than 10- pack years
             (number of packs smoked per day x number of years smoked)

          -  Donation or loss of greater than 400 mL of blood within the previous 3 months

          -  Have received any prescription medication within 4 weeks or investigational medication
             within 12 weeks of study (exception: contraceptives are permitted)

          -  Have received any non-prescription medication within 14 days prior to dosing
             (exception: paracetamol use within 2 days)

          -  Upper respiratory tract infection (excluding otitis media) within 14 days of the first
             study day, or lower respiratory tract infection within the last 3 months

          -  If female, nursing, lactating or pregnant

          -  Regular alcohol consumption in males >21 units per week and females >14 units per week
             (1 unit = ½ pint beer, 25 mL of 40% spirit or a 125 mL glass of wine)

          -  Surgery scheduled during the study or within 3 weeks after last dose

          -  History of familial long QT syndrome or history of sudden death in family members aged
             < 30 years
Safety, Tolerability and Pharmacokinetics of ERX-963 in Adults With Myotonic Dystrophy Type 1
Condition: Myotonic Dystrophy, Type 1 (DM1); Myotonic Dystrophy
MeSH terms: Myotonic Dystrophy
Intervention: ERX-963; Placebo
Intervention description: Active medicine; Comparator
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Excessive Daytime Sleepiness; hypersomnia

Summary:

      Participants in this study will receive two treatments, placebo and ERX-963, on different
      days in a randomized fashion.

      The primary purpose of this study is to investigate the safety and tolerability of ERX-963 in
      participants diagnosed with Myotonic Dystrophy, Type 1 (DM1).

      The secondary purpose is to evaluate the potential of ERX-963 treatment to reduce excessive
      daytime sleepiness / hypersomnia and improve cognitive function in DM1 participants compared
      to placebo treatment.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  18 to 65 years of age

          -  DM1 defined by genetic testing or clinical-confirmation

          -  Epworth Sleepiness Scale (ESS) of > 11 or participants who have long sleep periods of
             an average of > 10 hours a day

          -  Age of onset of DM1 greater than 16 years

        Key Exclusion Criteria:

          -  Significant respiratory compromise

          -  Significant cardiac disease

          -  Diagnosis of symptomatic Restless Leg Syndrome or significant untreated nocturnal
             hypoxias

          -  Significant moderate to severe hepatic insufficiency

          -  Clinically active depression, anxiety, or other medical condition that, in the
             investigator's opinion, would interfere with the safety and efficacy assessments

          -  History of seizures

          -  History of panic disorders
A Study of LY3009104(Baricitinib) for Healthy Subjects
Condition: Healthy Volunteer
Intervention: LY3009104; Placebo
Intervention description: Administered orally; Administered orally
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 34.0
Sex: All
Minimum age: 20 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      To evaluate the safety and tolerability of LY3009104 when given orally as single and multiple
      doses in Japanese healthy subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy males or females. Male subjects: Agree to use 2 forms of highly effective
             methods of birth control with female partners of childbearing potential for the
             specified duration. Female subjects: Females must not be pregnant, breastfeeding, or
             at risk to become pregnant during study participation. Female subjects of childbearing
             potential must test negative for pregnancy at screening and agree to use 2 forms of
             highly effective methods of birth control, or remain abstinent for the specified
             duration.

          -  Up to third generation Japanese, that is defined as all of the subject's biological
             grandparents are of exclusive Japanese decent and have been born in Japan.

          -  Are between the body mass index (BMI) of 18.0 and 30.0 kg/m², inclusive at screening.

        Exclusion Criteria:

          -  Are subjects who have previously completed or withdrawn from this study or any other
             study investigating LY3009104, and received the study drug.

          -  Have a history of or current cardiovascular, respiratory, hepatic, renal,
             gastrointestinal, endocrine, hematological, or neurological disorders capable of
             significantly altering the absorption, metabolism, or elimination of drugs; of
             constituting a risk when taking the study medication; or of interfering with the
             interpretation of data.

          -  Show evidence of significant active neuropsychiatric disease.

          -  Have current or recent history of herpes zoster or simplex in the last 90 days prior
             to randomization, or history of herpes zoster, such as disseminated herpes zoster
             involving multiple dermatomes, ocular involvement, including herpes zoster involving
             the ophthalmic branch of the trigeminal nerve.

          -  Have or have a history of rheumatoid arthritis.

          -  History of malignancy, with the exception of cured basal cell or squamous cell
             carcinoma of the skin.

          -  History of stomach or intestinal surgery, except that appendectomy and/or
             cholecystectomy will be allowed.

          -  Receipt of blood products within 2 months prior to study entry.
Metabolic Signatures and Biomarkers in Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: Aripiprazole; Risperidone; Healthy volunteers
Intervention description: Aripiprazole for 4 weeks; Subjects will be randomized to risperidone for 4 weeks; Healthy volunteers
Intervention MeSH terms: Risperidone; Aripiprazole
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 71.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Schizophrenia; Metabolomics

Summary:

      We plan to use a metabolomics lipid platform to map biochemical signatures in unmedicated
      schizophrenic patients prior to and 4 weeks post treatment with the antipsychotic drug
      aripiprazole and compare that to lipid perturbations induced by risperidone. These drugs have
      inherently different risk for metabolic adverse effects and patients respond to them
      differently. Metabolic signatures for the drugs capture significant biochemical information
      that could explain part of the basis for varied drug response within individuals and will
      highlight pathways implicated in drug action and in disease pathogenesis possibly enabling
      new drug design strategies. In addition, we will compare patients to healthy controls at
      baseline in regard lipid profiles.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18-60 years

          -  Diagnosis of schizophrenia

          -  Actively psychotic

          -  No more than a single dose of antipsychotic in the preceding 2 weeks

        Exclusion Criteria:

          -  Mental retardation, epilepsy or history of head trauma

          -  Substance use disorder that explains the majority of the psychopathology

          -  Pregnant or lactating females
Effect of 1,25-dihydroxyvitamin D3, Treatment on Insulin Secretion and Muscle Strength in Pre-diabetic Persons
Condition: Pre-Diabetic
MeSH terms: Prediabetic State
Intervention: Calcitriol capsules; Oral Placebo
Intervention description: 0.25micrograms, taken daily for eight weeks, orally; Placebo will be created to mimic the appearance of the study drug
Intervention MeSH terms: Calcitriol
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 17.0
Sex: All
Minimum age: 20 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Pre-menopausal women

Summary:

      The purpose of this research is to study the effects of 1,25(OH)2 D3 (a prescription form of
      active Vitamin D) on muscle strength and insulin secretion by the pancreas and glucose
      utilization by skeletal muscle.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Body mass index (BMI) of >24kg/m2

          -  Fasting serum glucose <126 mg/dL

        Exclusion Criteria:

          -  BMI</=24 kg/m2

          -  Fasting serum glucose >/=126 mg/dL

          -  Patient is taking Calcium or Vitamin D supplements and is unwilling to stop for 8
             weeks

          -  Serum Calcium >10.2 mg/dL

          -  Serum inorganic phosphorous >4.5mg/dL

          -  Pregnancy or breastfeeding

          -  Diagnosis of Diabetes Mellitus

          -  Diagnosis of Rheumatoid Arthritis

          -  Diagnosis of Chronic Obstructive Pulmonary Disease (COPD)

          -  Renal in sufficiency/failure ( serum creatinine >1.5 mg/dL men, > 1.3 mg/dL women)

          -  Chronic active liver disease (bilirubin >1.2 mg/dL, AST>144IU/L, or ALT >165 IU/L)

          -  History of chronic hepatitis

          -  Active coronary artery disease ( unstable angina, myocardial infarction, stroke and
             revascularization of coronary, peripheral or carotid artery within the last 3 months)

          -  Oral warfarin group medications or history of blood clotting disorders

          -  Platelet count <100,000 per uL within the last 7 days

          -  Alcohol consumption greater than 2 glasses/day or other substance abuse

          -  Untreated or uncontrolled thyroid disorders (outside a TSH range of 0.5 to 10mIU/L)

          -  Debilitating chronic disease (at the discretion of the investigators)

          -  The presence of infections, highly communicable diseases ( AIDS, active tuberculosis,
             venereal disease, hepatitis)

          -  Any malignancy
Reduced Intensity Transplant in Medically Refractory Systemic Lupus Erythematosus (SLE) and Systemic Sclerosis (SSc)
Condition: Systemic Lupus Erythematosus; Systemic Sclerosis
MeSH terms: Lupus Erythematosus, Systemic; Scleroderma, Systemic; Scleroderma, Diffuse; Sclerosis
Intervention: Reduced Intensity Allogeneic Transplant; Fludarabine; Busulfan; Campath
Intervention description: Eeduced intensity allogeneic stem cell transplantation with a fludarabine/busulfan/alemtuzumab conditioning regimen is anticipated to result in mixed and/or complete donor chimerism and potentially alter the natural history and outcome of patients with medically refractory Systemic Lupus Erythematosus (SLE) or Systemic Sclerosis (SSc).; Fludarabine 30 mg/m2 Day -7, -6, -5, -4, -3, -2; Busulfan 3.2 mg/kg Days _8, -7, -6, -5; Campath: 2 mg/m2 Day -5; 6 mg/m2 Day -4, -3; 20 mg/m2 Day -2
Intervention MeSH terms: Fludarabine; Busulfan; Alemtuzumab
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1.0
Sex: All
Minimum age: 7 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: Autoimmune Disease; Reduced Intensity Transplant

Summary:

      The purpose of this study is to determine if a reduced intensity (RI) (non-myeloablative)
      chemoimmunotherapy followed by Allogeneic Stem Cell Transplantation AlloSCT (matched family
      donors and matched unrelated cord blood donors) will be well tolerated.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diffuse Systemic Sclerosis and variants as per ACR criteria

          -  Medically refractory disease

          -  Adequate Organ Function - Pulmonary function

          -  Renal function, Cardiac function defined as:

          -  SGOT (AST) or SGPT (ALT) <5 x upper limit of normal

          -  Diagnosis of SLE - Medically refractory disease

        Exclusion Criteria:

          -  Karnofsky/Lansky <60%
A Study Of PF-06263507 In Patients With Advanced Solid Tumors
Condition: Neoplasms; Carcinoma, Non Small Cell Lung; Breast Neoplasms; Ovarian Neoplasms
MeSH terms: Neoplasms; Breast Neoplasms; Carcinoma, Non-Small-Cell Lung; Ovarian Neoplasms
Intervention: PF-06263507; PF-06263507
Intervention description: Part 1 - PF-06263507 will be administered intravenously in 21-day cycles in cohorts of 2 or more patients starting at a dose of 0.05 mg/kg. Increases in dose will continue until MTD is determined.; Part 2 - Patients with select tumor types will be treated at the MTD or Recommended Phase 2 dose selected in Part 1.
Intervention MeSH terms: PF-06263507
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Masking: None (Open Label)
Enrollment: 26.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: ADC 5T4; PF-06263507; solid tumors; lung cancer; breast cancer; ovarian cancer; cancer; tumors; neoplasm metastasis

Summary:

      To assess the safety and tolerability at increasing dose levels of PF-06263507 in patients
      with advanced solid tumors in order to determine the maximum tolerated dose and select the
      recommended Phase 2 dose.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of solid tumor that is advanced/metastatic and resistant to standard therapy
             or for which no standard therapy is available.

          -  Performance Status of 0 or 1.

          -  Adequate bone marrow, kidney, liver, and heart function.

        Exclusion Criteria:

          -  Brain metastases requiring steroids.

          -  Major surgery or anti-cancer therapy within 4 weeks of study treatment start.

          -  Active bacterial, fungal or viral infection.
Phase 1b Study of Tizanidine in Pediatric Patients With Cerebral Palsy
Condition: Spasticity Due to Cerebral Palsy
MeSH terms: Muscle Spasticity; Cerebral Palsy
Intervention: Zanaflex Capsules; Zanaflex Capsules; Zanaflex Capsules; Zanaflex Capsules
Intervention description: 0.025 mg/kg; 0.05 mg/kg; 0.075 mg/kg; 0.1 mg/kg
Intervention MeSH terms: Clonidine; Tizanidine
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 2 Years
Maximum age: 16 Years
Healthy volunteers: No

Summary:

      A Single-Dose, Phase 1b, Multicenter, Open-Label Study to Assess the Pharmacokinetics, Safety
      and Tolerability, and Pharmacodynamics of Tizanidine at 4 Different Oral Dose Levels in
      Pediatric Subjects 2 to 16 Years Old With Mild to Moderate Spasticity Due to Cerebral Palsy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have clinically diagnosed spasticity resulting from cerebral palsy

          -  Have a motor disability resulting from a static, nonprogressive brain injury or
             malformation occurring prenatally or before the age of 2 years

          -  Have mild to moderate spasticity at screening

          -  Have a parent or legally accepted representative able to understand and comply with
             study requirements who voluntarily provides informed consent and agrees to be
             primarily responsible for adhering to the requirements of the study

        Exclusion Criteria:

          -  Have a history of hypersensitivity or allergic reaction to tizanidine or any of the
             capsule components

          -  Have dietary restrictions or food allergies that conflict with a standardized meal

          -  Have clinically significant psychiatric, gastrointestinal, pulmonary, hematologic,
             endocrine, cardiovascular, renal, or hepatic disease that requires pharmacologic
             intervention

          -  Have an ongoing seizure disorder that requires medical therapy
Evaluation of Continuous Glucose Monitoring in Participants With Type 2 Diabetes Mellitus (MK-0000-258 AM2)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Vildagliptin; Placebo
Intervention MeSH terms: Vildagliptin
Phase: Phase 1
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: Single (Participant)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Maximum age: 79 Years
Healthy volunteers: No

Summary:

      This trial will attempt to develop the use of Continuous Glucose Monitoring (CGM) as a tool
      for the evaluation of both new and existing pharmacological treatments for type 2 diabetes,
      using the twice daily administered dipeptidyl peptidase-4 (DPP4) inhibitor, vildagliptin as a
      probe. The primary hypothesis is that two weeks of treatment with 50 mg of oral Vildagliptin,
      twice daily will lead to a statistically significant decrease in 24 hour weighted-mean
      glucose (WMG) relative to placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of type 2 diabetes mellitus on a clinical regimen that is metformin
             alone, up to a maximum of 3 gram per day, on a background of lifestyle measures, and
             has a Hemoglobin A1C at screening of > 7%.

          -  If on antihyperglycemic therapy with both metformin and sulfonylurea with a Screening
             Visit/Visit 1 Hemoglobin A1C of >= 6.5% and =< 7.5%, should then discontinue
             sulfonylurea usage and undergo washout of sulfonylurea.

        Exclusion Criteria:

          -  History of either stroke, chronic seizures or major neurological disorder within the
             last 6 months.

          -  Untreated hypertension with a blood pressure of > 160/95 mmHg.

          -  History of neoplastic disease within the past 5 years.

          -  History of hypersensitivity to vildagliptin or other DPP4 inhibitors.

          -  Had major surgery, or donated or lost 1 unit (500 mL) of blood, or participated in
             another investigational study within 4 weeks prior to screen.

          -  Used any illicit drug or abusively used alcohol within the past 3 months.
Bioequivalence of Metformin Under Fed Conditions After Administration of Linagliptin / Metformin Fixed Dose Combination Tablet and Single Tablets
Condition: Healthy
MeSH terms: Malnutrition
Intervention: Linagliptin/metformin; Metformin; Linagliptin
Intervention description: FDC; single tablet Metformin; single tablet Linagliptin
Intervention MeSH terms: Metformin; Linagliptin
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      To establish bioequivalence (BE) under fed conditions between metformin in
      linagliptin/metformin fixed dose combination tablet and metformin reference product
      administered in free combination togther with linagliptin
    

Eligibility criteria:

        Inclusion criteria:

        1. Healthy male and female subjects

        Exclusion criteria:

        1. Any relevant deviation from healthy conditions
Relative Bioavailability of Two Different Capsule Formulations of Sitravatinib in Healthy Adults
Condition: Tumor
Intervention: Sitravatinib; Sitravatinib
Intervention description: Administered orally as a free base capsule; Administered orally as a malate salt capsule
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 26.0
Sex: Male
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The primary objective of the study was to investigate the relative bioavailability and
      pharmacokinetics (PK) of sitravatinib free base and malate salt capsule formulations
      following oral administration in healthy adults.
    

Eligibility criteria:

        Key Inclusion Criteria:

          1. Body mass index between 18.0 and 32.0 kg/m2, inclusive.

          2. In good health, determined by no clinically significant findings from medical history,
             physical examination, 12-lead ECG, vital sign measurements, and clinical laboratory
             evaluations at Screening and/or Check-in as assessed by the Investigator (or
             designee).

          3. Able to swallow multiple capsules.

        Key Exclusion Criteria:

          1. History of stomach or intestinal surgery or resection

          2. Have previously completed or withdrawn from this study or any other study
             investigating sitravatinib and have previously received the investigational product.

          3. Participants who, in the opinion of the Investigator (or designee), should not
             participate in this study.

        NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.