bioihbjkbjnl/mcl2 huggingface dataset:
Study to Evaluate the Pharmacokinetics of Filgotinib in Participants With Impaired Hepatic Function
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Filgotinib
Intervention description: 100 mg tablet administered orally
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The primary objective of this study is to evaluate the pharmacokinetics (PK) of filgotinib
      and its metabolite, GS-829845, in participants with varying degrees of impaired hepatic
      function relative to matched, healthy controls.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Eligible individuals will be male and nonpregnant, nonlactating females, aged 18 to 70
             years (inclusive), body mass index (BMI) between 18 and 36 kg/m^2 (inclusive), with
             either impaired hepatic function or normal hepatic function.

          -  Individuals will be current nonsmokers (no use of tobacco, nicotine-containing, or
             tetrahydrocannabinol [THC]-containing products within the last 14 days).

          -  Individuals with hepatic impairment will be categorized by the Child-Pugh-Turcotte
             (CPT) classification system indicating hepatic impairment as follows:

               -  Class A (mild): CPT score 5-6

               -  Class B (moderate): CPT score 7-9

               -  Class C (severe): CPT score 10-15

          -  Hepatic impairment must have been stable during the 3 months (90 days) prior to study
             drug. Each individual in the control group will be matched to a individual with
             impaired hepatic function by age (± 10 years), gender, and body mass index (± 15%).

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
TAK-114 Single- and Multiple-Dose Phase 1 Study
Condition: Clinical Pharmacology
Intervention: TAK-114 10 mg capsule; TAK-114 matched placebo
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 82.0
Sex: Male
Minimum age: 20 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to evaluate the safety and tolerability of TAK-114 following
      single and multiple ascending oral doses in healthy Japanese male participants.
    

Eligibility criteria:

        Inclusion Criteria:

        Healthy Japanese participants:

          -  Must be willing to provide written informed consent and in the investigator's opinion
             able to comply with the study protocol.

          -  Is aged 20 to 45 years, inclusive.

          -  Weighs at least 50 kilogram (kg) and have a body mass index (BMI) between 18.5 and
             25.0 kilogram per square meter (kg/m^2).

        Healthy Caucasian participants:

          -  Must be willing to provide written informed consent and in the investigator's opinion
             able to comply with the study protocol.

          -  Is aged 20 to 45 years, inclusive; are of Caucasian descent (born to Caucasian parents
             and grandparents and has lived outside original country for less than 5 years) and
             maintains their original diet and lifestyle.

          -  Weighs at least 50 kg and have a body mass index between 18.5 and 30.0 kg/m2.

        Exclusion Criteria:

        • Participants have a known hypersensitivity to any component of the formulation of TAK-114
        or any herb medicine or supplement related to Indigo naturalis.
Autologous Adult Stem Cells to Patients With Type 1 Diabetes and a Successful Renal Transplant
Condition: Type 1 Diabetes; Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: Autologous CD34+ stem cells
Intervention description: Up to 5 x 10 log 8 of autologous stem cells on a single occasion
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Autologous stem cells
Masking: None (Open Label)
Enrollment: 7.0
Sex: All
Minimum age: 16 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: diabetes type I; diabetes type 2; renal transplant; stem cells; successful renal transplant

Summary:

      This is a phase I study to assess the safety and tolerability of infusing expanded stem cells
      into the pancreas of patients with type I diabetes and a successful renal transplant. The
      stem cells used in this study occur naturally in the body and are collected from each
      recipient by a procedure called leukapheresis. The cells are then expanded and differentiated
      into insulin-like cells in a sterile suite before being injected into the body or tail of the
      pancreas of the recipient.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female patients aged from 16 to 65 years of age

          -  Patient with Type I or Type 2 diabetes mellitus plus:

          -  Successful previous kidney transplant.

          -  Good kidney allograft function /no episodes of rejection for at least one year
             post-transplant

          -  Not taking steroids as part of standard immuno-suppression

          -  Has a WHO performance score of less than 2

          -  Has a life expectancy of at least 3 months

          -  Ability to give written consent

          -  Women of childbearing potential may be included, but must use a reliable and
             appropriate contraceptive method

        Exclusion Criteria:

          -  Patients below the age of 16 or above the age of 65 years

          -  Patients with chronic pancreatitis and poor exocrine pancreatic function

          -  Pregnant or lactating women

          -  Patients with recent recurrent GI bleeding or spontaneous bacterial peritonitis

          -  Patients with evidence of HIV or other life threatening infection

          -  Patients unable to give written consent

          -  Patients with a history of hypersensitivity to G-CSF

          -  Patients who have been included in any other clinical trial within the previous month
Mouse Cancer Cell-containing Macrobeads in the Treatment of Human Cancer
Condition: Intraabdominal Cancers (Various Types)
Intervention: Cancer Macrobead placement in abdominal cavity
Intervention description: 8 macrobeads per kg
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 56.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: intraabdominal cancer (carcinomas); agarose macrobeads; mouse kidney cancer cells; cancer cell growth inhibition

Summary:

      This is a phase 1 trial to evaluate the safety and toxicity of mouse kidney cancer
      cell-containing agarose-agarose macrobeads that are implanted in the abdominal cavity as a
      proposed biological treatment of patients with end-stage, treatment-resistant cancer. The
      macrobeads have been extensively tested in tumor models in mice and rats, as well as in
      forty-five veterinary patients (cats and dogs) with naturally occurring tumors of various
      types including breast cancer, prostate cancer, liver cancer, and lymphoma with clear tumor
      responses and no significant detectable toxicity.
    

Eligibility criteria:

        Inclusion Criteria:

          -  End-stage, treatment resistant epithelial-derived cancer (carcinoma) arising
             originally within the abdominal cavity with expected minimum six-month survival

        Exclusion Criteria:

          -  Multiple intraabdominal metastases or carcinomatosis or other medical conditions
             indicating that the procedure would be of too high a risk for the individual
Study to Compare the Effects of Repeated Doses of an Investigational New Drug and a Placebo on Appetite in Advanced Cancer and Anorexia
Condition: Non-small Cell Lung Cancer; Pancreatic Cancer; Colorectal Cancer; Prostate Cancer; Breast Cancer; Ovarian Cancer; Loss of Appetite; Fatigue; Cachexia; Anorexia
MeSH terms: Wasting Syndrome; Fatigue; Anorexia; Cachexia
Intervention: PF-06946860; Placebo for PF-06946860
Intervention description: subcutaneous injection; subcutaneous injection
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking description: Double-blind, sponsor open for 6-week double-blind treatment period followed by an optional 18-week open-label treatment period.
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: cancer, anorexia, cachexia, weight loss, loss of appetite, fatigue

Summary:

      Study to compare the effects of the investigational new drug (PF-06946860) and a placebo on
      appetite and to find out how participants with advanced cancer and anorexia feel after
      receiving repeated subcutaneous (SC-injected under the skin) doses.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Documented diagnosis of non-small cell lung, pancreatic, colorectal, prostate, breast
             or ovarian cancer which, in the treating oncologist's assessment, is considered
             advanced.

          -  Anorexia as defined by a score of ≤5 in the Cancer-Related Cachexia Symptom Assessment
             Appetite 7-day recall scale

          -  Meets any of the following criteria at Randomization:

               -  Not currently receiving antineoplastic therapy

               -  On standard of care systemic antineoplastic therapy or treatment without curative
                  intent

          -  Signed informed consent.

        Key Exclusion Criteria:

          -  Receiving tube feedings or parenteral nutrition at the time of Screening or
             Randomization.

          -  Current active reversible causes of decreased food intake.

          -  Current, severe gastrointestinal disease

          -  Participants with known symptomatic brain metastases requiring steroids.

          -  Active uncontrolled bacterial, fungal, or viral infection, including HBV, HCV, HIV or
             participants with known AIDS-related illness

          -  inadequate renal or liver function.

          -  Women who are pregnant or breast-feeding
Development of a mHealth Intervention for Ambivalent Smokers
Condition: Tobacco Use Disorder; Smoking Cessation; Motivation; Behavior, Smoking
MeSH terms: Tobacco Use Disorder
Intervention: Control mHealth program; Experimental mHealth program; Nicotine patch
Intervention description: The intervention includes a mHealth intervention that is grounded in best practice recommendations for treatment of nicotine dependence.; The intervention includes a mHealth intervention that is grounded in best practice recommendations for treatment of nicotine dependence. Experimental participants also receive additional content designed to motivate smoking reduction/quitting and provide skills training.; Participants in both arms can earn the ability to request a 2-week supply of over-the-counter nicotine patches. Patches are earned through accumulated use of the assigned mHealth program.
Intervention MeSH terms: Nicotine
Phase: Phase 1
Study type: Interventional
Primary purpose: Device Feasibility
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 57.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: mHealth; smoking; smoking cessation; motivation

Summary:

      The current pilot study will assess the feasibility and acceptability of a novel mHealth app
      designed for people who are ambivalent about quitting smoking. Results will be used to refine
      the intervention and plan for a future randomized effectiveness trial.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 years or older;

          -  Can speak/read English;

          -  Current smoker;

          -  Own and regularly use an eligible smartphone;

          -  No vision impairments;

          -  Willing to install and use the study program;

          -  Willing to use birth control if elect to use nicotine replacement during the study
             (females);

          -  Meet definition for ambivalence

          -  Not actively using treatment

        Exclusion Criteria:

          -  Smoke less than 10 cigarettes per day

          -  Self-report a lifetime history of dementia, manic depression, bipolar disorder, or
             schizophrenia;

          -  Have medical contraindications for nicotine replacement therapy;

          -  Another household member is enrolled in the study

          -  Unable to verify contact information

          -  Fail to install app
A Study of Extended-release (ER) Niacin/Laropiprant in Adolescents With Heterozygous Familial Hypercholesterolemia (MK-0524A-158)
Condition: Hypercholesterolemia, Familial; Heterozygous Familial Hypercholesterolemia
MeSH terms: Hyperlipoproteinemia Type II; Hypercholesterolemia
Intervention: MK-0524A; MK-0524A
Intervention description: 1 tablet of MK-0524A (1g ER niacin/20mg laropripant) orally; 2 tablets of MK-0524A (1g ER niacin/20mg laropripant) orally
Intervention MeSH terms: Niacin; Niacinamide; Nicotinic Acids
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 10 Years
Maximum age: 16 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine the pharmacokinetics of laropiprant following
      administration of a single dose of 1 (Panel A) and 2 (Panel B) combination tablets of
      MK-0524A in adolescents with heterozygous familial hypercholesterolemia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Post-pubescent adolescent age 10 to 16 with heterozygous familial hypercholesterolemia

          -  Agree to use (and/or have their partner use) acceptable methods of birth control
             beginning at the prestudy visit until at least 2 weeks after dosing of study drug

          -  Height and weight fall between the 10th and 95th percentile for age with a minimum
             body weight of 23 kg

          -  Receiving appropriate medical care for hypercholesterolemia, such as a statin or other
             lipid-modifying therapy.

        Exclusion Criteria:

          -  History of psychiatric or personality disorders that may affect the patient's ability
             to participate

          -  History of stroke, chronic seizures, or major neurological disorder

          -  History of clinically significant endocrine, gastrointestinal, cardiovascular,
             hematological, hepatic, immunological, renal, respiratory, or genitourinary
             abnormalities or diseases (excluding lipid abnormalities)

          -  Poorly controlled or recently diagnosed Type 1 or Type 2 diabetes mellitus

          -  History of neoplastic disease within previous 5 years

          -  Consumes alcohol or excessive amounts of products that contain caffeine (e.g. cola)

          -  Has had major surgery, donated and/or received blood within previous 8 weeks

          -  Participated in another investigational study within previous 4 weeks

          -  History of significant multiple and/or severe allergies (including latex allergy), or
             has had an anaphylactic reaction or significant intolerability to prescription or
             non-prescription drugs or food

          -  Positive for hepatitis B surface antigen, hepatitis C antibodies or human
             immunodeficiency virus (HIV)

          -  Cannot swallow large tablets

          -  Pregnant or breastfeeding
Safety And PK Study Of CVX-060 In Patients With Advanced Solid Tumors
Condition: Advanced Solid Tumors; Neoplasms; Carcinoma; Cancer; Malignancy
MeSH terms: Neoplasms
Intervention: CVX-060
Intervention description: Weekly, intravenous dose
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 34.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Phase 1; Tumors; CVX-060

Summary:

      The purpose of this study is to determine the safety and tolerability of CVX-060 in patients
      with advanced solid tumors.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed advanced solid tumors unresponsive to currently available therapies or for
             which there is no standard therapy.

          -  Adequate coagulation, liver, and renal function.

          -  Candidate for DCE-MRI evaluations.

          -  ECOG (Eastern Cooperative Oncology Group) performance status of 0 or 1.

        Exclusion Criteria:

          -  Evidence of significant bleeding problems.

          -  History of certain gastrointestinal problems including fistula and abscess.

          -  Chronic, uncontrolled hypertension.

          -  Patients with any history of primary or metastatic tumor involvement of the brain or
             with tumors that encase great vessels.
Preoperative Anti-PD-1 Antibody Combined With Chemoradiotherapy for Locally Advanced Squamous Cell Carcinoma of Esophagus
Condition: Esophageal Squamous Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Esophageal Squamous Cell Carcinoma
Intervention: Pembrolizumab
Intervention description: Arm1：Pre-operative Pembrolizumab+chemoradiotherapy
Intervention MeSH terms: Pembrolizumab
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Participants will receive carboplatin (AUC=2) IV and paclitaxel (50mg/m²) IV on day 1,8,15,22,29. And radiotherapy will start on day 1 of chemotherapy. A total of 41.4 Gy, 23 fractions of 1.8 Gy, 5 fractions a week. Participants will also receive pembrolizumab (2mg/kg) IV on days 1 and 22. Surgery will be performed within 6 weeks after completion of preoperative therapy described above
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: esophageal squamous cell carcinoma; neoadjuvant chemoradiotherapy; pembrolizumab; immune therapy; checkpoint inhibitor

Summary:

      This study will evaluate the safety and feasibility of preoperative immune checkpoint therapy
      with concurrent chemoradiotherapy in patients with locally advanced esophageal squamous cell
      carcinoma. And this study will provide valuable information for further clinical trials of
      preoperative pembrolizumab and other immune checkpoint therapy in esophageal cancer
      treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A patient will be eligible for inclusion in this study only if ALL of the following
             criteria apply:

               1. Histologically confirmed cT2-T4a,N0-N+,M0 resectable esophageal squamous cell
                  carcinoma

               2. Eastern Cooperative Oncology Group (ECOG) performance status 0-1

               3. Patients approve and sign the informed consent

        Exclusion Criteria:

          -  1. Patients with active autoimmune disease or history of autoimmune disease 2.
             Patients who have a condition requiring systemic treatment with either corticosteroids
             or other immunosuppressive medications 3. Subjects with a history of symptomatic
             interstitial lung disease 4. History of allergy to study drug components 5. Women must
             not be pregnant or breast-feeding 6. Men with female partners (WOCBP) that are not
             willing to use contraception 7. Patient has received prior chemotherapy, radiotherapy,
             target therapy and immune therapy for this malignancy or for any other past malignancy
             8. Underlying medical conditions that, in the Investigator's opinion, will make the
             administration of study drug hazardous or obscure the interpretation of toxicity or
             adverse events
Pharmacokinetic And Pharmacodynamic Study Of A Single-Dose Of PF-04950615 (RN316) In Combination With Atorvastatin
Condition: Hypercholesterolemia; Dyslipidemia
MeSH terms: Hypercholesterolemia; Dyslipidemias
Intervention: 4 mg/kg; 0.5 mg/kg
Intervention description: RN316 10 mg/ml vial sd. Infusion based on weight Infusion duration = 60 minutes.; RN316 10 mg/ml vial sd. Infusion based on weight Infusion duration = 60 minutes.
Intervention MeSH terms: Bococizumab
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Hypercholesterolemia; Dyslipidemia; LDL; Cholesterol; High Cholesterol; PF-04950615; RN316

Summary:

      The primary objective of this study is to evaluate the pharmacokinetics and pharmacodynamics
      of a single dose of PF-04950615 (RN316) in volunteers on stable doses of atorvastatin.
      PF-04950615 (RN316) is an investigational drug that is currently being studies as a
      cholesterol lowering therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  On stable doses of atorvastatin (40 mg daily) for 45 days prior to Day 1.

          -  BMI 18.5 to 40 kg/m2 inclusive, and body weight equal or lower than 150 kg.

        Exclusion Criteria:

          -  History of a cardiovascular event (e.g., MI ) during the past year.

          -  Poorly controlled Type 1 or Type 2 Diabetes mellitus (definition: uncontrolled
             diabetes is defined as HBIAc >9%).

          -  Poorly controlled hypertension (uncontrolled hypertension is defined as a systolic
             blood pressure greater than 140 mm Hg or a diastolic blood pressure greater than 90 mm
             Hg, even with treatment). Subjects who have hypertension and are controlled on stable
             dosages of anti-hypertensive medications can be included.