bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Compare the Adhesiveness of 2 Different Rotigotine Patches Used for the Treatment of Parkinson's Disease
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Intervention: Rotigotine (Test product PR 2.3.1); Rotigotine (Reference product PR 2.1.1)
Intervention description: Pharmaceutical form: Transdermal patch
Concentration: 8 mg/24 hours
Route of administration: Transdermal; Pharmaceutical form: Transdermal patch
Concentration: 8 mg/24 hours
Route of administration: Transdermal
Intervention MeSH terms: Rotigotine
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 57.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Rotigotine patch; Neupro; Parkinson's Disease

Summary:

      The primary objective of the study is to compare the adhesiveness of 2 different patch
      formulations of Rotigotine using the largest patch size of 40 cm^2, under the assumption that
      both patch formulations show similar adhesiveness properties.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject has a diagnosis of idiopathic Parkinson's Disease

          -  Subject has been on continuous treatment with commercially available Rotigotine
             transdermal patches (Neupro®) for at least 3 months prior to enrollment

          -  Subject has been taking a stable Rotigotine dose including an 8 mg/24 hours (40 cm^2)
             patch for at least 2 weeks prior to enrollment

        Exclusion Criteria:

          -  Subject has any medical or psychiatric condition which, in the opinion of the
             investigator, could jeopardize or would compromise the subject's well-being or ability
             to participate in this study

          -  Subject has a history of significant skin hypersensitivity to adhesives or other
             transdermal products or recently unsolved contact dermatitis

          -  Subject has a history or present condition of an atopic or eczematous Dermatitis,
             Psoriasis, or an active skin disease

          -  Subject has a lifetime history of suicide attempt (including an active attempt,
             interrupted attempt, or aborted attempt), or has suicidal ideation in the past 6
             months as indicated by a positive response ('yes') to either Question 4 or Question 5
             of the Columbia-Suicide Severity Rating Scale (C-SSRS) at Screening (Visit 1) or
             Baseline (Visit 2)
A Study of LY3127760 in Healthy Participants
Condition: Healthy Volunteers
Intervention: LY3127760; Celecoxib; Placebo
Intervention description: Administered orally; Administered orally; Administered orally
Intervention MeSH terms: Celecoxib
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Enrollment: 80.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The main purposes of this study are to evaluate the safety and how well the body handles
      single and multiple doses of increasing strength of study drug, LY3127760. This study
      includes three parts. Part 3 may be initiated at sponsor's discretion, based on data from
      Part 2. Participants will only enroll in 1 of the 3 study parts. This study will last
      approximately 7 to 13 weeks, depending on part. Screening must be completed within 28 days
      prior to enrollment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Overtly healthy males or females as determined by medical history and physical
             examination

          -  Male participants agree to use a reliable method of birth control during the study and
             3 months following the last dose of the investigational product

          -  Female participants not of child-bearing potential

          -  Have a body mass index of 18.5 to 32 kilograms per square meter (kg/m^2) inclusive

          -  Are normotensive (defined as supine systolic blood pressure [BP] less than 140
             millimeters of mercury [mm Hg] and diastolic BP less than 90 mm Hg) without use of any
             antihypertensives

        Exclusion Criteria:

          -  Have known allergies to LY3127760, related compounds or any components of the
             formulation, celecoxib or sulfonamides, or history of significant atopy. Participants
             with known aspirin allergy or allergic reactions to nonsteroidal anti-inflammatory
             drugs (NSAIDs) should also be excluded

          -  Have any current or prior history of a significant gastrointestinal illness such as
             peptic ulcer disease, gastrointestinal (GI) bleeding, chronic gastritis, inflammatory
             bowel disease or chronic diarrhea

          -  Have evidence of other chronic liver disease, including but not limited to chronic
             alcoholic disease, nonalcoholic steatohepatitis, recent history (within 3 months of
             screening) of acute viral hepatitis or chronic autoimmune hepatitis

          -  Have used any NSAIDs, celecoxib, aspirin or acetaminophen (at doses greater than 1
             gram per day), anticoagulants or antiplatelet agents within 14 days of admission

        Part 2 and Part 3 only

          -  Have 1 plus pretrial pitting edema or 2 plus ankle or pedal edema
Nintedanib and Weekly Docetaxel in Lung Adenocarcinoma
Condition: Carcinoma, Non-Small-Cell Lung
MeSH terms: Adenocarcinoma; Carcinoma, Non-Small-Cell Lung; Adenocarcinoma of Lung
Intervention: Docetaxel; Nintedanib; Nintedanib; Nintedanib; Nintedanib
Intervention description: Low Dose; Medium dose; High dose; Continuous high dose
Intervention MeSH terms: Docetaxel; Nintedanib
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Phase I study. To determine the MTD (Maximum Tolerated Dose) of nintedanib + weekly Docetaxel
      in patients with locally advanced or metastatic lung adenocarcinoma after failure of
      platinum-based first line chemotherapy.
    

Eligibility criteria:

        Inclusion criteria:

        -Patients with histologically/ cytologically confirmed locally advanced (Stage IIIB) or
        metastatic (Stage IV) lung adeno carcinoma after failure of first line platinum - based
        chemotherapy (patients with non-target lesion only are eligible).

        First line chemotherapy may include continuation or switch maintenance therapy. One prior
        adjuvant and/or neoadjuvant chemotherapy line is accepted. Prior immunotherapy is allowed.

          -  ECOG inferior or equal to 1 at screening.

          -  Further inclusion criteria apply

        Exclusion criteria:

          -  Patients who have received more than one prior line of chemotherapy (i.e. second or
             third line chemotherapy) for advanced or metastatic NSCLC.

          -  Patients known to be positive for activating Epidermal Growth Factor Receptor (EGFR)
             mutation or patients known to be positive for ALK translocation

          -  Further exclusion criteria apply.
A Study of PF-04217903 in Patients With Advanced Cancer
Condition: Neoplasms
Intervention: PF-04217903
Intervention description: Escalating doses of PF-04217903 will be administered orally on a continuous dosing schedule. Doses to be evaluated will range from 50 mg BID to 1000 mg BID. A cycle is considered to be 21 days
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      PF-04217903 may work in cancer by blocking the cell growth, migration and invasion of tumor
      cells. PF-04217903 is a new member in a class of drugs called c-Met/hepatocyte growth factor
      receptor tyrosine kinase inhibitors. This research study is the first time PF-04217903 will
      be given to patients. PF-04217903 is taken by mouth daily.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Advanced solid tumors, histologically proven at diagnosis which is refractory to
             standard of care or for whom no standard of care therapy is available

          -  Adequate blood cell counts, normal kidney function, and performance status of 0 or 1

        Exclusion Criteria:

          -  Major surgery, radiation therapy or anti-cancer therapy within 2 weeks of starting
             study treatment

          -  Prior stem cell transplant

          -  Active or unstable cardiac disease or heart attack within 12 months of starting study
             treatment
A Phase 1, Open-label Study to Investigate the Pharmacokinetics of Tralokinumab (CAT-354) in Adolescents With Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: Tralokinumab 300 mg
Intervention description: Participants aged 12 to 14 years and 15 to 17 years will receive a single dose of tralokinumab (CAT-354) 300 mg, subcutaneously on Day 1.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 12 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Tralokinumab; CAT-354; Asthma

Summary:

      The pharmacokinetic (PK) profile of tralokinumab (CAT-354) will be studied in adolescent
      subjects with asthma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 12-17 years (inclusive)

          -  Weight greater than (>) 30 kilogram (kg)

          -  Asthma for a minimum of 6 months prior to Screening

          -  Effective birth control for both male and female participants in line with protocol
             details.

          -  Exclusion Criteria:

          -  Previously taken tralokinumab (the study drug)

          -  Employee of the clinical study site or any other individuals directly involved with
             the conduct of the study, or immediate family members of such individuals

          -  Pregnant or breastfeeding women

          -  Current smoker or cessation less than (<) 3 months prior to screening

          -  Known immune deficiency excluding asymptomatic selective immunoglobulin A

          -  History of cancer - Hepatitis B, C or human immunodeficiency virus (HIV) positive

          -  Any disease which may cause complications whilst taking the study drug.
Study of Erenumab (AMG 334) in Women With Hot Flashes
Condition: Vasomotor Symptoms; Hot Flashes
MeSH terms: Hot Flashes
Intervention: Erenumab; Placebo
Intervention description: Administered via subcutaneous injection.; Administered via subcutaneous injection
Intervention MeSH terms: Erenumab
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 103.0
Sex: Female
Minimum age: 45 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Vasomotor symptoms; Hot Flashes; Menopause

Summary:

      The primary objective of this study was to evaluate the frequency of moderate to severe daily
      hot flashes 4 weeks after a single dose of erenumab (AMG 334) in women with hot flashes
      associated with menopause.
    

Eligibility criteria:

        Inclusion Criteria:

          -  female subjects with hot flashes associated with menopause between 45 and 65 years of
             age, inclusive, with no history or evidence of clinically relevant medical disorders
             as determined by the investigator in consultation with the Amgen physician.

        Exclusion Criteria:

          -  History or evidence of clinically significant disorder (including psychiatric),
             condition or disease that, in the opinion of the Investigator or Amgen physician would
             pose a risk to subject safety or interfere with the study evaluation, procedures, or
             completion.
Safety And Tolerability Study Of RN6G In Subjects With Advanced Dry, Age-Related Macular Degeneration Including Geographic Atrophy
Condition: Age-Related Maculopathy; Age-Related Maculopathies; Eye Diseases; Retinal Degeneration; Macular Degeneration
MeSH terms: Macular Degeneration; Eye Diseases; Geographic Atrophy; Retinal Degeneration; Atrophy
Intervention: RN6G; Placebo
Intervention description: Intravenous, multiple dose, dose ranging from 5 mg/kg up to a maximum of 15 mg/kg; Intravenous, multiple dose with experimental dose
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 24.0
Sex: All
Minimum age: 60 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Phase 1b Advanced Dry Age-Related Macular Degeneration RN6G

Summary:

      The purpose of this study is to determine the safety and tolerability of multiple doses of
      RN6G in subjects with advanced dry, age-related macular degeneration including geographic
      atrophy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Be of non-child bearing potential

          -  Diagnosis of dry AMD including uni- or multi-focal geographic atrophy without foveal
             involvement

          -  BCVA of 20/50 or better in the study eye

        Exclusion Criteria:

          -  Evidence of ocular disease other than advanced AMD or GA in the study eye

          -  History or diagnosis of exudative (wet) AMD, with subretinal or choroidal neovascular
             lesions in the study eye

          -  Presence of disease or condition that might compromise the cardiovascular,
             hematological, renal, hepatic, pulmonary, endocrine, central nervous immune, or
             gastrointestinal system

          -  Requires ocular or systemic medications that are known to be toxic to the lens, retina
             or optic nerve
A Safety Study Of A Monoclonal Antibody Against A5B1 Integrin In Solid Tumors
Condition: Advanced Non-Hematologic Malignancies
MeSH terms: Neoplasms
Intervention: PF-04605412
Intervention description: PF-04605412 will be administered as 2 hr IV infusion every 4 or 2 weeks. Start dose is 7.5 mg. Multiple doses are foreseen. Treatment will continue until intolerable toxicity, progression of disease or patient's refusal
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 33.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Neoplasms; monoclonal antibody; PF-04605412; advanced metastatic solid tumors

Summary:

      Dose finding study of the MoaB PF-04605412 directed against the alpha5beta1 integrin. Main
      objective is to define the MTD (maximum tolerated dose) or MAD (maximum administrable dose)
      in cancer patients pre treated or unresponsive to standard therapies.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed advanced measurable or evaluable solid
             tumors unresponsive to currently available therapies, or for which there is no
             curative therapy

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0 and 1

          -  Life expectancy more than12 weeks

          -  Adequate bone marrow, liver and renal function

        Exclusion Criteria:

          -  Known brain metastasis

          -  Chemotherapy, radiotherapy, or any investigational cancer therapy within 4 weeks of
             start of screening procedures

          -  Major surgical procedure within 4 weeks of start of screening procedures

          -  Active bleeding disorder, including gastrointestinal bleeding, as evidenced by
             hematemesis, significant hemoptysis or melena in the past 6 months
Does Pulmonary Rehabilitation Improve Balance in People With Respiratory Disease?
Condition: Lung Diseases
MeSH terms: Lung Diseases; Respiratory Tract Diseases; Respiration Disorders
Intervention: Pulmonary rehabilitation
Intervention description: Pulmonary rehabilitation involves the prescription of customized exercise programs and education on disease management.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: All
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether participation in pulmonary rehabilitation
      improves balance in people with respiratory disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of lung disease

          -  Committed to regular attendance at pulmonary rehabilitation program

          -  A forced expiratory volume in 1 second (FEV1) < 80% of predicted

          -  No change in medications for the past 2 months

        Exclusion Criteria:

          -  Unstable cardiac disease

          -  Neurological conditions

          -  Musculoskeletal conditions that prevent participation in exercise sessions.
A Study to Evaluate the Safety, Tolerability, and Blood Levels of PF-03654746 in Subjects With Mild to Moderate Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Intervention: PF-03654746; Placebo
Intervention description: PF-03654746 capsule of 0.25 mg, 0.5 mg, and 1.0 mg strength. Drug is dosed orally once a day. Forced titration dosing for the first 15 days of the study being at 0.25 mg for 5 days, then 0.5 mg for days 6-10, then 1.0 mg for days 11-15. Flexible dosing for the next 15 days depending on tolerability and safety assessments done by the investigator.; Matching placebo capsules to PF-03654746 with strengths of 0.25 mg, 0.5 mg, and 1.0 mg.
Drug is dosed orally once a day. Forced titration dosing for the first 15 days of the study being at 0.25 mg for 5 days, then 0.5 mg for days 6-10, then 1.0 mg for days 11-15. Flexible dosing for the next 15 days depending on tolerability and safety assessments done by the investigator.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 9.0
Sex: All
Minimum age: 55 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Phase 1 Alzheimer's disease Safety Tolerability Pharmacokinetics

Summary:

      This is a study to evaluate the safety, tolerability and blood levels of PF-03654746 in
      subjects will mild to moderate Alzheimer's disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Probable Alzheimer's disease

          -  Mini Mental State Examination score 18-26 inclusive

          -  Aged 55-85

        Exclusion Criteria:

          -  Dementia other than Alzheimer's disease

          -  Clinically significant cardiovascular disease in the past 6 months prior to screening

          -  Creatinine clearance <30 mL/min
A Study of How MK-0736 Affects Arterial Plaque (0736-006)(TERMINATED)
Condition: Peripheral Vascular Diseases
MeSH terms: Vascular Diseases; Peripheral Vascular Diseases; Peripheral Arterial Disease
Intervention: MK-0736; Comparator: placebo (unspecified)
Intervention description: MK-0736; 7mg once daily, orally at approximately the same time each morning for 12 weeks.; Matching Placebo once daily, orally at approximately the same time each morning for 12 weeks.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      A 12-Week Efficacy Study in participants with Peripheral Arterial Disease. the primary
      hypothesis is that MK-0736 7 mg administered once daily for 12 weeks will result in a
      decrease in lower extremity atherosclerotic plaque macrophage content when compared to
      placebo (an approximate decrease of up to 30% is expected).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants with peripheral arterial disease

          -  Participants must be 18 to 85 years of age

          -  Females must be postmenopausal or sterile

        Exclusion Criteria:

          -  Participans with hepatic, HIV, endocrine, connective tissue, psychiatric disorders or
             uncontrolled hypertension
A Study of LY900014 in Elderly and Younger Adult Participants With Type 1 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: LY900014; Insulin Lispro
Intervention description: Administered SC; Administered SC
Intervention MeSH terms: Insulin Lispro
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 80.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to compare LY900014 with insulin lispro (Humalog) in elderly and
      younger adults with type 1 diabetes mellitus.

      Screening is required within 28 days prior to the start of the study. For each participant,
      the total duration of the clinical trial will be between 3 to 8 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Are male or female participants with Type 1 Diabetes Mellitus (T1DM)

          -  Have a body mass index (BMI) of 18.5 to 30.0 kilogram per meter square (kg/m²)

          -  Have a glycated hemoglobin (HbA1c) less than (<)9.0 percent (%)

          -  Have had no episodes of severe hypoglycaemia in the last 6 months

        Exclusion Criteria:

          -  Have a history or current cardiovascular, respiratory, hepatic, renal,
             gastrointestinal, endocrine (apart from T1DM), hematological, or neurological
             disorders capable of significantly altering the absorption, metabolism, or elimination
             of drugs; of constituting a risk when taking the investigational product; or of
             interfering with the interpretation of data

          -  Have a history of renal impairment

          -  Have a history of deep vein thrombosis of the leg or repeated episodes of deep leg
             vein thrombosis in first-degree relatives

          -  Have proliferative retinopathy or maculopathy and/or severe neuropathy