bioihbjkbjnl/mcl2 huggingface dataset:
Bioequivalence Study of Zolpidem Tartrate Tablets and Ambien® Under Fasting Conditions
Condition: Healthy
Intervention: Zolpidem Tartrate 10 mg tablet; Zolpidem Tartrate 10 mg tablet (Ambien®)
Intervention description: 10 mg tablet administered after an overnight fast of at least 10 hours; 10 mg tablet administered after an overnight fast of at least 10 hours
Intervention MeSH terms: Zolpidem
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 38.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: equivalency; Therapeutic equivalency

Summary:

      The purpose of this study is to compare the bioequivalence of a test formulation of zolpidem
      tartrate tablets to an equivalent oral dose of the commercially available reference drug
      product Ambien® (zolpidem tartrate tablets) in adult subjects under fasted conditions.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Sex: Male or Female; similar proportions of each preferred

          -  Age: At least 18 years

          -  Weight: must be 15% of ideal weight for height and frame

          -  Subjects must be in good health and physical condition as determined by medical
             history

          -  Subjects must read and sign the Consent Form

        Exclusion Criteria:

          -  History of treatment for alcoholism, substance abuse, or drug abuse within past 24
             months.

          -  History of malignancy, stroke, diabetes, cardiac, renal or liver disease, or other
             serious illness.

          -  History of GERD, malabsorption syndrome, colon cancer, or chronic colitis, including
             Crohn's disease.

          -  History of treatment for asthma within the past five (5) years.

          -  History of mental depression.

          -  History of pulmonary disease.

          -  History of sleep apnea.

          -  Females who are pregnant or lactating.

          -  History of hypersensitivity to zolpidem tartrate, or any hypnotic or sedative.

          -  Treatment with any other investigational drug during the four weeks prior to the
             initial dosing of the study.

          -  Donation of blood within four weeks prior to the initial dosing of the study

          -  Smokers or subjects who use tobacco/nicotine products. Three months abstinence is
             required.
Thorough QT Study to Evaluate the Effects of BI 207127 (Deleobuvir) Combined With Faldaprevir on Cardiac Safety Parameters in Healthy Subjects.
Condition: Healthy
Intervention: BI 207127; BI 207127 placebo; Faldaprevir placebo; Faldaprevir; Moxifloxacin (Avalox®)
Intervention description: Medium dose oral administration; Medium dose oral administration
Intervention MeSH terms: Moxifloxacin
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single
Enrollment: 48.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The objective of this study is to evaluate the effect of multiple doses of BI 207127 combined
      with faldaprevir on cardiac safety parameters in healthy subjects
    

Eligibility criteria:

        Inclusion criteria:

          -  Healthy male and female subjects

          -  Subjects must be able to understand and comply with study requirements

          -  Age =18 and =55 years

          -  BMI range: =18.5 and =29.9 kg/m2

        Exclusion criteria:

        - any relevant deviation from healthy conditions
Safety and Tolerability of Dalfampridine in Subjects With Cerebral Palsy
Condition: Cerebral Palsy (CP)
MeSH terms: Cerebral Palsy
Intervention: dalfampridine-ER 10mg; Placebo
Intervention MeSH terms: 4-Aminopyridine
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 35.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      A double-blind, placebo-controlled, crossover study in subjects with cerebral palsy (CP) to
      evaluate the safety and tolerability and the effect of dalfampridine extended release (ER)
      tablets on sensorimotor function
    

Eligibility criteria:

        Inclusion Criteria:

          -  A diagnosis of CP

          -  No previous use of any dalfampridine formulation

          -  Ability to perform all the required study procedures. Subjects should be capable of
             fully extending and flexing both hands

        Exclusion Criteria:

          -  Presence of any progressive neurological disease

          -  Severe CP defined as the requirement to use a wheelchair at all times and a care taker
             for constant assistance in daily activities. This definition includes spastic
             quadriplegia

          -  Pregnant or breastfeeding
A Phase 1, First in Human Study to Investigate the Safety and Tolerability of PA401
Condition: Healthy Volunteers
Intervention: PA401; Placebo
Intervention description: Part A of Study: Subcutaneous, 0.1mg to 50mg, single ascending doses Part B of Study: Subcutaneous, up to 17.1mg, single dose; Subcutaneous
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 49.0
Sex: Male
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Phase 1; First in Human; Healthy Volunteers; Lipopolysaccharide Challenge

Summary:

      The purpose of this study is to examine the safety, tolerability, immunogenicity and the way
      the body absorbs, distributes, breaks down and excretes various increasing single and
      multiple subcutaneous doses of PA401 in healthy subjects.

      This study will also look at the effect of PA401 on inflammation in the lungs following an
      inhaled lipopolysaccharide (LPS) challenge (LPS is a bacterial cell wall fragment) and sputum
      induction (a procedure performed to help to cough up sputum (phlegm)) after a single
      subcutaneous dose of two dose levels.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy adult males aged 18 to 65 years

        Exclusion Criteria:

          -  Subjects with a clinically relevant medical history
Evaluation of Infectivity and Illness of Norwalk GI.1 Virus Lot 001-09NV in the Human Challenge Model
Condition: Norovirus Infection
MeSH terms: Caliciviridae Infections
Intervention: Norwalk GI.1 Virus
Intervention description: Norwalk virus causes viral gastroenteritis, which is also known as acute nonbacterial gastroenteritis, food poisoning, food infection, or stomach flu.
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: A total of 16 eligible healthy young adults will be challenged with either the moderate or higher dose of norovirus inoculum
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Maximum age: 49 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      There is a need for safe, highly infectious Norovirus inocula for use in Norovirus
      vaccine-challenge studies to assess the efficacy of Norovirus vaccines and examine the immune
      response among vaccinated and unvaccinated subjects. The purpose of this study is to generate
      the infection and illness rate and immune response data necessary for the conduct of future
      investigation of Norovirus vaccine studies.
    

Eligibility criteria:

        Inclusion Criteria:

          -  General good health, without significant medical illness, based on medical history,
             physical examination, vital signs, and clinical laboratories (CBC, chemistry, and
             urinalysis) as determined by the investigator in consultation with the research
             monitor and sponsor

          -  Available for all planned visits and to spend at least 5 days in confinement

          -  Confirmed blood type (A or O)

          -  Demonstrated to be H type-1 antigen secretor positive (by saliva test)

          -  Body mass index between 17 and 30 at screening

          -  Female subjects must have a negative pregnancy test and either use contraceptives or
             be sterile

          -  Available to return for follow-up visits following discharge from the inpatient unit
             and deliver stool specimens to the investigator promptly

        Exclusion Criteria:

          -  Presence of significant medical condition

          -  Donation or use of blood or blood products within 4 weeks prior to challenge

          -  Diagnosed bleeding disorder or significant bruising or bleeding difficulties that
             could make blood draws problematic

          -  Abnormal stool pattern

          -  Any gastroenteritis within the past 2 weeks

          -  Occupational hazards, including having daily contact with children under the age of 5,
             women known to be pregnant, employment in the food service industry, health care
             workers, etc.
An Exploratory Clinical Study on a Variable Speed and Sensing Treadmill System (VASST) for Hemiparetic Gait Rehabilitation
Condition: Stroke; Hemiplegic Gait
MeSH terms: Stroke; Gait Disorders, Neurologic
Intervention: Variable Speed and Sensing Treadmill
Intervention description: open label study on variable speed and sending treadmill training for hemiplegic gait training.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Healthy volunteers: No
Keywords: Stroke; Hemiplegia; Variable automated treadmill treadmill

Summary:

      To conduct a feasibility clinical trial to test a novel patient sensing automated treadmill
      device devised by local engineers for subacute hemiplegic stroke patients for gait
      rehabilitation. This is a phase 1 feasibility and safety trial on the above device for 10
      chronic stroke patients with hemiparetic gait dysfunction to be conducted over a period of 2
      months.

      Research protocol and standardized outcomes measures will be used.
    

Eligibility criteria:

        Inclusion Criteria:

          1. First ever stroke (ischaemic or haemorrhagic) confirmed on Computed Tomography or
             Magnetic Resonance imaging

          2. Aged 21 - 80 years

          3. Stroke duration of >3 months in outpatient phase (subacute -chronic stroke)

          4. Able to walk overground at a self-selected speed of >0.2m/s with or without walking
             aids or lower limb orthoses for at least 150 meters with contact guard or supervision.

          5. Functional ambulation category (FAC >/= 2) (Holden et al 1994)

        Exclusion Criteria:

          1. Cardiovascular conditions such as uncontrolled hypertension/hypotension, angina
             pectoris, recent myocardial infarction, congestive cardiac failure, known
             echocardiographic ejection fraction < 40% within 3 months of stroke, chronic
             arrhythmias (e.g. atrial fibrillation) within 3 months of study screening, pacemaker,
             uncontrolled Diabetes Mellitus.

          2. End stage illness (advanced malignancy), pregnancy or end stage renal failure with
             life expectancy of <6 months.

          3. Aphasia (inability to obey 2 step commands), communication disorder precluding
             understanding of instructions, cognitive impairment, dementia, untreated depression or
             psychiatric disorder.

          4. Active lower limb arthritis, Pain (Visual Analogue Scale) >5/10, fixed orthopaedic
             deformities of the lower limb which would compromise safe ambulation on treadmill.

          5. Moderate to severe lower limb spasticity or spasms (Modified Ashworth Scale >2)

          6. Active trunk skin conditions, known abdominal aortic aneurysm, anticoagulation with
             warfarin precluding safe fit of gait harness
A Study of JNJ-30979754 (Decitabine) in Patients With Myelodysplastic Syndrome
Condition: Myelodysplastic Syndrome
MeSH terms: Preleukemia; Myelodysplastic Syndromes; Syndrome
Intervention: JNJ-30979754 15 mg/m2; JNJ-30979754 20 mg/m2
Intervention description: JNJ-30979754 (decitabine) 15 mg/m2 will be administered once daily by 1-hour intravenous infusion from Day 1 to 5 of 4-Week (28-day) Cycle 1.; Phase I: JNJ-30979754 (decitabine) 20 mg/m2 will be administered once daily by 1-hour intravenous infusion from Day 1 to 5 of 4-Week (28-day) Cycle 1. Phase II: JNJ-30979754 (decitabine) 20 mg/m2 will be administered once daily by 1-hour intravenous infusion from Day 1 to 5 of 4-Week (28-day) cycles until the decitabine was expected to be effective in participants.
Intervention MeSH terms: Decitabine
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 39.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Myelodysplastic syndrome; MDS; Decitabine; JNJ-30979754

Summary:

      The purpose of this study is to to determine the recommended dose level of JNJ-30979754
      (decitabine) as well as to assess the safety and effectiveness in patients with
      Myelodysplastic Syndrome (MDS).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Myelodysplastic syndrome (de novo or secondary) fitting any of the recognized
             French-American-British classifications: refractory anemia, refractory anemia with
             ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with
             excess blasts in transformation, chronic myelomonocytic leukemia with white blood
             cells less than 13,000 /mm3

          -  International Prognostic Scoring System (IPSS) greater than or equal to 0.5
             (Intermediate-1, Intermediate-2 or high risk) by bone marrow assessment and bone
             marrow cytogenetics within 28 days before study registration

          -  20 years or older

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0-2

          -  Normal renal and hepatic function

        Exclusion Criteria:

          -  Acute Myeloid Leukemia (AML) with bone marrow blasts greater than or equal to 30%

          -  Participants with a history of high-dose cytarabine (Ara-C) therapy (greater than
             1,000 mg/m2/day)

          -  Participants administered adrenal cortex hormones or anabolic hormones within 7 days
             of study initiation

          -  Participants who have received a colony stimulating factor (CSF) formulation within 7
             days of study initiation

          -  Active double cancer

          -  Uncontrolled cardiac disease or cognitive heart failure

          -  Uncontrolled restrictive or obstructive pulmonary disease

          -  Uncontrolled diabetes mellitus

          -  Active viral or bacterial infection

          -  Known positive serology for Human immunodeficiency virus
Estimation Of Effect Of Rifampin On Pharmacokinetics Of Crizotinib In Healthy Volunteers
Condition: Healthy
Intervention: crizotinib; rifampin; crizotinib
Intervention description: Treatment A: a single 250-mg dose of crizotinib will be administered in the fasted state on Day 1 as 1 × 50-mg and 2 × 100-mg Immediate Release Tablets.; Treatment B: 600 mg once a day doses of rifampin will be orally administered after overnight fasting from Day 1 to Day 14.; Treatment B: A single 250-mg dose of crizotinib will be administered in the fasted state on Day 9 as 1 × 50-mg and 2 × 100-mg Immediate Release Tablets.
Intervention MeSH terms: Rifampin; Crizotinib
Phase: Phase 1
Study type: Interventional
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: crizotinib; healthy volunteers; rifampin; pharmacokinetics; single dose

Summary:

      The purpose of this study is to estimate the effect of multiple doses of Rifampin on the
      single dose pharmacokinetics of Crizotinib in healthy volunteers.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy male and/or female of non-child bearing potential subjects between the ages of
             18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities
             identified by a detailed medical history, full physical examination, including blood
             pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).

          -  Body Mass Index (BMI) of 17.5 to 30.5 kg/m^2; and a total body weight >50 kg (110
             lbs).

        Exclusion Criteria:

          -  Subjects with evidence of disease, conditions affecting drug absorption, treatment
             with other investigational drug within 30 days, history of regular alcohol
             consumption, and use of prescription , nonprescription drugs and dietary supplement
             within 7 days, and blood donation of 500 mL within 56 days.
ADSC Injections for Pain Management of Osteoarthritis in the Human Knee Joint
Condition: Osteoarthritis of the Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Intervention: ADSC
Intervention description: Single injection of ADSC
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
Minimum age: 20 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: ADSC; osteoarthritis; knee; adipose

Summary:

      This safety and feasibility study used autologous adipose-derived stromal cells (ADSC), the
      stromal vascular fraction (SVF), to treat 8 osteoarthritic (OA) knees in 6 patients of grade
      I to III (K-L scale) with initial pain of 4 or greater on a 10 point scale, under
      Institutional Review Board (IRB) approved protocol.
    

Eligibility criteria:

        Inclusion Criteria:

          -  voluntarily provided written Informed Consent

          -  ages 20-70

          -  male or female

          -  grades I-III radiologically documented OA of one or both knees

          -  American Society Anaesthesiologists (ASA) physical status class I-II and a • BMI less
             than 35

          -  knee pain graded as greater than 3 out of 10 on screening questionnaire

          -  able to speak, read and understand English -

        Exclusion Criteria:

          -  patient parameters falling outside of the inclusion criteria

          -  current oral or parenteral steroid or blood thinner use

          -  hyaluronic acid-based injection to the affected knee joint within the previous six
             months

          -  corticosteroid injection to the affected knee joint within the previous three months

          -  end stage (Grade IV) OA
Tolerability Comparison Between Differin® Cream 0.1% Versus Differin® Lotion 0.1% in Subjects With Healthy Skin
Condition: Skin Manifestations
MeSH terms: Skin Manifestations
Intervention: adapalene cream 0.1%; adapalene lotion 0.1%
Intervention description: adapalene cream 0.1% - apply once daily on one side of the face for 3 weeks; adapalene lotion 0.1% - apply once daily on the opposite side of the face for 3 weeks
Intervention MeSH terms: Adapalene
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 75.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to compare the tolerability of Differin® (adapalene) Cream, 0.1%
      to Differin® Lotion, 0.1% in subjects with healthy skin treated once a day for three (3)
      weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males or females aged 18 years and older

          -  Subjects with healthy skin as determined by the clinical grader.

        Exclusion Criteria:

          -  Subjects with a degree of skin pigmentation that interferes with the reading of skin
             reactions.

          -  Subjects with a condition or who are in a situation, which in the investigator's
             opinion may put the subject at risk, may confound study results, or may interfere with
             the subject's participation in the study

          -  Subjects with known allergy to one of the components of the study drugs (refer to the
             package insert for Differin® Cream 0.1% and the investigator's brochure for Differin®
             Lotion 0.1%)

          -  Subjects who have participated in another investigational drug or device research
             study within 30 days of enrollment.

          -  Subjects with a washout period for topical treatment on the treated area less than 1
             week for corticosteroids and/or 4 weeks for retinoids.

          -  Subjects with a washout period for systemic treatment less than 1 week for medications
             that may increase photosensitivity and/or 4 weeks for corticosteroids and/or 6 months
             for retinoids.

          -  Subjects with current sunburn, eczema, atopic dermatitis, perioral dermatitis or
             rosacea on the area to be treated.

          -  Subjects who foresee unprotected and intense UV exposure during the study (mountain
             sports, UV radiation, sunbathing, etc.).