bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Intensified Physical Activity for Patients With Stroke - a Combined Physical and Behavioural Approach
Condition: Stroke
MeSH terms: Stroke
Intervention: High-Intensity Functional Exercise Programmes (HIFE)
Intervention description: Hife include functional exercises consisting of everyday tasks challenging leg strength, postural stability, and gait ability. All exercise shall be performed in weight-bearing positions, eg squats and walking over obstacles. HIFE are performed twice a week during 1 h. for three months in a group with 6-7 seven patients with stroke. Two physiotherapists lead the group and one physiotherapist select exercises for each participant according to their functional deficits. The exercises will be progressively increased in load and difficulty.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 67.0
Sex: All
Minimum age: 65 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: stroke; physical activity; balance; muscle-strength

Summary:

      Chronic conditions such as stroke are associated with physical disability and an economic
      burden for the family and the society. A medical approach is often not sufficient to address
      the bio-psychological process of chronic disease. Behavioural medicine approaches are often
      needed to improve the treatment outcomes. Those approaches have often successfully been used
      together with physical activity to change health behaviour in inactive individuals and in
      pain management. In this project the combined approach of behavioural medicine principles and
      physical training will be tried on patients who have had a stroke one year ago where it has
      yet only been used scarcely. As the study focus on the individuals' ability to function and
      be active the primary outcome measure is disability. The aim of the study are in a randomized
      controlled study evaluate if a high intense functional exercise program as an group
      intervention under three months can influence functional, psychosocial, anthropometric and
      biochemical factors 3, 6 months and 1 year after the start of the study. Following outcome
      variables will be analyzed:

        1. level of physical activity, motor function and balance

        2. depression and health-related quality of life

        3. body mass index (BMI), metabolic risk profile, inflammation status

        4. number of falls, fall-related self-efficacy and outcome expectations
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient with first-ever stroke in the age of 65-65 years getting their stroke at least
             one year ago and living in the community.

        Exclusion Criteria:

          -  Other illness or disability that have an impact on the activity level and
             participation in tests beside problems after stroke.
Study Evaluating SKI-606 (Bosutinib) In Advanced Malignant Solid Tumors
Condition: Neoplasms
Intervention: bosutinib; bosutinib; bosutinib; bosutinib
Intervention description: Dose levels evaluated 50mg, 100mg, 200mg, 300mg, 400mg, 500mg and 600mg. 500mg was identified as MTD, however due to GI toxicities at that dose, 400mg was selected as the RP2D. Drug was administered as long as tolerable and disease under study did not worsen.; 400mg QD bosutinib, as long as tolerated and disease under study does not worsen.; 400mg QD bosutinib, as long as tolerated and disease under study does not worsen.; 400mg QD bosutinib, as long as tolerated and disease under study does not worsen.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 151.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Solid tumors

Summary:

      To evaluate the safety and tolerability of oral SKI-606 (bosutinib) administered on a daily
      schedule to subjects with advanced malignant solid tumors and to define a maximum tolerated
      dose (MTD) in this subject population.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Advanced or recurrent solid malignancy confirmed histologically or cytologically for
             which no effective therapy is available.

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1.

          -  Measurable disease as outlined by the modified Response Evaluation Criteria in Solid
             Tumors (RECIST) criteria.

          -  Other inclusion applies.

        Exclusion Criteria:

          -  Use of any systemic antitumor agents or any investigational agent within 28 days
             before the first dose of test article is administered.

          -  Prior exposure to SKI-606 or any other Src-kinase inhibitor, major surgery or
             radiotherapy within 14 days before the first dose of test article (recovery from
             previous surgery should be complete before day 1).

          -  Active central nervous system (CNS) metastases, as indicated by clinical symptoms,
             cerebral edema, requirement for corticosteroids and/or progressive growth (Treated CNS
             metastases must be stable for >= 2 weeks before day 1).

          -  Other exclusion applies.
Amoxicillin Drug Interaction Study With MMX® Mesalazine/Mesalamine
Condition: Healthy
Intervention: Amoxicillin + MMX placebo; Amoxicillin + MMX mesalazine/mesalamine
Intervention description: MMX placebo administered once a day (QD) orally on Days 1-3, then a single oral dose of Amoxicillin (500 mg) + MMX placebo on Day 4.; MMX mesalazine/mesalamine (4.8 g) administered QD orally on Days 1-3, then a single oral dose of Amoxicillin (500 mg) + MMX mesalazine/mesalamine (4.8 g) on Day 4.
Intervention MeSH terms: Amoxicillin; Mesalamine
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 62.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a drug interaction study evaluating the pharmacokinetic profiles of amoxicillin
      administered alone & in combination with MMX Mesalazine/mesalamine.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age 18-55 years inclusive at the time of consent. The date of signing informed consent
             is defined as the beginning of the Screening Period.

          2. Subject is willing to comply with any applicable contraceptive requirements of the
             protocol and is:

               -  Male, or

               -  Non-pregnant, non-lactating female

               -  Females must be at least 90 days post-partum or nulliparous.

        Exclusion Criteria

          1. A history of current or recurrent disease that could affect the colon. This includes
             gastrointestinal disease, peptic ulceration, gastrointestinal bleeding, celiac
             disease, lactose intolerance, ulcerative colitis, Crohn's disease, or Irritable Bowel
             Syndrome. Subjects who have a history of chronic constipation, which is physician
             diagnosed and treated, will also be excluded from the study (frequency of bowel
             movements >48 hours between samples).

          2. A history of current or relevant serious, severe, or unstable (acute or progressive)
             physical or psychiatric illness.

          3. A history of gastrointestinal surgery performed within the past 12 months prior to the
             first dose of investigational product, with the exception of an appendectomy.

          4. A history of or current clinically relevant moderate or severe renal or hepatic
             impairment.

          5. A history of asthma or bronchospasm associated with the use of 5-ASA or other
             non-steroidal anti-inflammatory drugs.

          6. Known or suspected intolerance or hypersensitivity to the investigational product or
             amoxicillin, closely related compounds, or any of the stated ingredients

          7. A history of, or current, pancreatitis
A Study Evaluating The PF-03084014 In Combination With Docetaxel In Patients With Advanced Breast Cancer
Condition: Breast Cancer Metastatic
MeSH terms: Breast Neoplasms
Intervention: PF-03084014; PF-03084014; PF-03084014; Docetaxel; Docetaxel
Intervention description: Tablet, 10 mg, twice a day; Tablet, 50 mg, twice a day; Tablet, 100 mg, twice a day; Solution for IV infusion 75 mg/m^2, every 3 weeks; Solution for IV infusion 100 mg/m^2, every 3 weeks
Intervention MeSH terms: Docetaxel; Nirogacestat
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Masking: None (Open Label)
Enrollment: 30.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Breast cancer metastatic; docetaxel; PF-03084014

Summary:

      This study is aimed to determine the tolerability of the PF-03084014 plus docetaxel
      combination in patients with advanced breast cancer. Preliminary information about the
      efficacy of the combination will also be collected.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of breast cancer with evidence of a) metastatic or b) locally
             recurrent/advanced disease.

        Exclusion Criteria:

          -  Prior treatment with a gamma secretase inhibitors or other Notch signaling inhibitors.
A 2 Part Study to Assess the Relative Bioavailability of Tablet Formulation Compared to Capsule Formulation and the Effect of Food and Taste Assessment on the Tablet Formulation in Healthy Participants
Condition: Healthy Volunteers
Intervention: RO7017773 Phase I Capsule; RO7017773 Phase II Tablet Unflavored; RO7017773 Phase II Tablet Sweetened/Flavored
Intervention description: Participants will receive 1 single oral dose of RO7017773 Phase I Capsule.; Participants will receive 3 single oral doses of unflavored RO7017773 Phase II tablet during Part 1, and 1 single oral dose of unflavored RO7017773 Phase II tablet during Part 2.; Participants will receive 1 single oral dose of sweetened/flavored RO7017773 Phase II tablet during Part 2.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a two-part, open-label, healthy volunteer study. Part I will investigate the relative
      bioavailability of capsule and tablet formulations of RO7017773. Part II will explore how the
      taste of the tablet formulation is perceived with and without added sweetener/flavoring.
    

Eligibility criteria:

        Inclusion Criteria

          -  Non-smoker for at least six months

          -  Healthy, as judged by the Investigator

          -  Women of non-childbearing potential (WONCBP) who are not pregnant or lactating

          -  Men must be willing to remain abstinent or agree to use contraceptive measures with
             partners who are women of childbearing potential (WOCBP), and must refrain from
             donating sperm, for at least 28 days after the last dose of study drug

        Exclusion Criteria

          -  History or evidence of any medical condition potentially altering the absorption,
             metabolism or elimination of drugs

          -  History of convulsions (other than benign febrile convulsions of childhood) including
             epilepsy, or personal history of significant cerebral trauma or CNS infections (e.g.
             meningitis)

          -  A history of clinically significant hypersensitivity (e.g., drugs, excipients) or
             allergic reactions

          -  Current or chronic history of liver disease, or known hepatic or biliary abnormalities

          -  Have used or intend to use over-the-counter or prescription medication including
             herbal medications within 30 days prior to dosing

          -  Participation in an investigational drug or device study within 90 days prior to
             screening

          -  Human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies

          -  Presence of hepatitis B surface antigen (HBsAg) or positive hepatitis C antibody test
             result at screening or within 3 months prior to starting study treatment
A Study to Evaluate the Effect of the Potent CYP3A4 Inhibitor Itraconazole on the Pharmacokinetics (PK) of TAK-906 in Healthy Participants
Condition: Healthy Participants
Intervention: TAK-906 Maleate; Itraconazole
Intervention description: TAK-906 capsule; Itraconazole solution
Intervention MeSH terms: Itraconazole
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Drug Therapy

Summary:

      The purpose of this study is to evaluate the effect of the potent cytochrome P-450 (CYP) 3A4
      inhibitor (itraconazole) on the single-dose PK of oral TAK-906 maleate.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Is a man or woman (with no child bearing potential) aged 18 to 55 years, inclusive, at
             the Screening Visit.

          2. Has a body mass index (BMI) greater than or equal to (>=) 18 and less than or equal to
             (<=) 30 kilogram per square meter (kg/m^2) and a body weight greater than (>) 50
             kilogram (kg) at the Screening Visit.

          3. Is a nonsmoker who has not used tobacco- or nicotine-containing products (example,
             nicotine patch) for at least 6 months before administration of the initial dose of
             trial drug/invasive procedure.

        Exclusion Criteria:

          1. Has a positive alcohol or drug screen.

          2. Has had a major surgery, donated or lost 1 unit of blood (approximately 500 milliliter
             [mL]) within 8 weeks of the first dose of study drug.

          3. Has a history of alcohol consumption exceeding 2 standard drinks per day on average (1
             glass is approximately equivalent to: beer [354 mL/12 ounces], wine [118 mL/4 ounces],
             or distilled spirits [29.5 mL/1 ounce] per day).

          4. Consumes excessive amounts, defined as greater than 6 servings (1 serving is
             approximately equivalent to 120 mg of caffeine) of coffee, tea, cola, energy drinks,
             or other caffeinated beverages per day.

          5. Has a substance abuse disorder.
SAD/MAD Study to Assess Safety, Tolerability, PK & PD of MEDI1814 in Subjects With Mild-Moderate Alzheimer's Disease.
Condition: Mild-Moderate Alzheimer's Disease; Healthy Elderly
MeSH terms: Alzheimer Disease
Intervention: MEDI1814 for IV injection; MEDI1814 for Subcutaneous Injection; IV Placebo; Placebo for Subcutaneous Injection
Intervention description: Monoclonal antibody for IV Injection; Monoclonal antibody for subcutaneous injection; Placebo for IV injection; Subcutaneous Placebo Injection
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 77.0
Sex: All
Minimum age: 55 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the safety, drug levels and effects on the body of 1
      or 3 injections of MEDI1814, in people with mild to moderate Alzhiemer's Disease or healthy
      elderly people.
    

Eligibility criteria:

        Inclusion Criteria Male and female (non child bearing potential) subjects Mild-moderate
        Alzheimer's Disease

        Exclusion Criteria History or evidence of significant autoimmune disease Presence of
        psychiatric disorder which would affect completion of the study Current serious or unstable
        clinically important illness
Monoclonal Antibody Therapy in Treating Patients With Progressive Small Cell Lung Cancer (SCLC)
Condition: Lung Cancer
MeSH terms: Lung Neoplasms; Small Cell Lung Carcinoma
Intervention: monoclonal antibody hu3S193
Intervention MeSH terms: Antibodies; Antibodies, Monoclonal
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: 18 Years
Healthy volunteers: No
Keywords: recurrent small cell lung cancer (SCLC)

Summary:

      RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver
      tumor-killing substances to them without harming normal cells.

      PURPOSE: This phase I trial is studying the side effects of monoclonal antibody therapy in
      treating patients with progressive small cell lung cancer (SCLC).
    

Eligibility criteria:

        Inclusion Criteria:

        Small cell lung cancer, pathologically confirmed. Measurable disease, including at least
        one lesion measuring ≥ 2 cm that has not been previously irradiated.

        Progression of disease after one, two, or three prior chemotherapy regimens. At least 4
        weeks since the last chemotherapy or radiation treatment. Karnofsky performance status ≥
        70% (ECOG 0 or 1).

        The following laboratory results within the last 2 weeks prior to study day 1:

        White Blood Cell Count (WBC) ≥ 3,500/mm3; Platelet count ≥ 100 x 10^9/L; Serum creatinine ≤
        2.0 mg/dL; Serum bilirubin ≤ 2.0 mg/dL; International normalized ratio (INR) ≤ 1.3; Women
        of childbearing potential with confirmed negative quantitative serum HCG on the day of
        administration of study agent.

        Negative stool guaiac test (read by laboratory). Tumor tissue positive for Lewis Y
        expression.

        Exclusion Criteria:

        Clinically significant cardiac disease (New York Heart Association Class III/IV).

        Uncontrolled brain or leptomeningeal metastases. GI bleed within the preceding 6 months.
        Patients with history of receiving mouse monoclonal antibody. Participation in any other
        clinical trial involving another investigational agent within 4 weeks prior to enrollment.

        Women who are pregnant or breast-feeding.
Adaptive Physical Activity for Chronic Stroke
Condition: Stroke
MeSH terms: Stroke
Intervention: APA-Stroke; Sittercise
Intervention description: Exercise program design specifically for individuals with residual hemiparetic gait deficits due to stroke. Exercises are progressive, beginning with a 5 minute walk at the beginning and end of each class and gradually progressing to a 15 minute walk at the beginning and end of each class. Exercises focus on walking and are designed to improve walking ability and balance. Program includes a homework component.; Not stroke specific. This less vigorous exercise program consists of seated exercise focusing on stretching to improve general range of movement and weight exercises to strengthen the trunk, arms, and legs. There is no assigned exercise homework.
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 76.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: stroke; exercise

Summary:

      This study will compare the Adaptive Physical Activity program (APA) to a less vigorous group
      exercise program, (Sittercise) to see if APA leads to greater improvements in walking
      endurance, quality of life, and participation in social activities.
    

Eligibility criteria:

        Inclusion Criteria:

          -  evidence of stroke (ischemic or hemorrhagic) minimum 6 months prior in men or women
             ages 40 or older;

          -  residual hemiparetic gait deficits;

          -  already completed all conventional inpatient and outpatient physical therapy;

          -  ability to rise from a chair unaided and without an assistive device

        Exclusion Criteria:

          -  cardiac history of active unstable angina, recent (less than 3 months) myocardial
             infarction, or congestive heart failure (NYHA category II or higher);

          -  orthopedic, circulatory, or chronic pain conditions restricting exercise;

          -  active cancer; poorly controlled hypertension ( greater than 180/100 on 2 readings
             separated by 5 minutes rest);

          -  dementia;

          -  severe receptive or global aphasia with inability to follow 2-step commands;

          -  co-morbid non-stroke neurological disorder that impairs mobility (e.g. multiple
             sclerosis or Parkinson's);

          -  untreated clinical depression;

          -  inability to complete the "6-Minute Walk" test during baseline testing
Evaluation Of Hepatic Impairment On AG-013736 Pharmacokinetics
Condition: Hepatic Insufficiency
MeSH terms: Hepatic Insufficiency; Liver Failure
Intervention: AG-013736; AG-013736; AG-013736
Intervention description: Single oral 5-mg dose of AG-013736, administered as a film-coated, immediate-release tablet.; Single oral 5-mg dose of AG-013736, administered as a film-coated, immediate-release tablet.; Single oral 5-mg dose of AG-013736, administered as a film-coated, immediate-release tablet.
Intervention MeSH terms: Axitinib
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: hepatic impairment

Summary:

      This study will evaluate the effects of mild and moderate impairment of hepatic function on
      the single-dose pharmacokinetics, safety and tolerability of AG-013736.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of reduced hepatic function (Child Pugh Classification A or B)

          -  Body Mass Index of 18-32 kg/m2

        Exclusion Criteria:

          -  History of febrile illness within 5 days prior to first dose

          -  Any condition possibly affecting drug absorption (e.g. gastrectomy)

          -  Positive urine drug screen
Relative Bioavailability of Empagliflozin (BI 10773) (Final Formulation) Compared to Empagliflozin (BI 10773 XX) (Trial Formulation 2) in Healthy Male and Female Volunteers
Condition: Healthy
Intervention: BI 10773 XX (Trial Formulation 2); BI 10773 (Final Formulation)
Intervention description: one single dose tablet in the morning; one single film-coated tablet in the morning
Intervention MeSH terms: Empagliflozin
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The objective of the study is to investigate the relative bioavailability of the final tablet
      formulation (FF) of BI 10773 in comparison to the tablet formulation 2 (TF2).
    

Eligibility criteria:

        Inclusion criteria:

        Healthy male and female subjects