bioihbjkbjnl/mcl2 huggingface dataset:
Multiple Ascending Doses of PF-04958242 in Subjects With Stable Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: PF-04958242; Placebo
Intervention description: Administered as specified in the treatment arm; Administered as specified in the treatment arm
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 39.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: Multiple ascending doses; safety; tolerability; pharmacokinetics; cognitive impairment associated with schizophrenia (CIAS)

Summary:

      This study aims to assess the safety, tolerability and pharmacokinetics of PF-04958242 in
      multiple ascending doses in subjects with stable schizophrenia.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Psychiatrically stable (≥3 months) male and female subjects with schizophrenia of
             non-childbearing potential between the ages of 18 and 55 years, inclusive.

          -  Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >55 kg (121 lbs).

          -  DSM-IV Diagnosis of Schizophrenia; on stable medication treatment regimen ≥2 months.

        Key Exclusion Criteria:

          -  Suicide attempt within 3 months prior to screening.

          -  History of or risk of seizures; head injury with long term abnormal resulting
             condition, abnormal EEG, clinically significant additional diseases or conditions,
             current medication with a significant risk of seizures, currently receiving
             antipsychotic medications.

        NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
A Study Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics of KA34 in Subjects With Knee Osteoarthritis
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Intervention: KA34; Placebo
Intervention description: 50 µg - 400 µg intra-articular injection (single or multiple doses); 50 µg - 400 µg intra-articular injection (single or multiple doses)
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 60.0
Sex: All
Minimum age: 40 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Osteoarthritis; Arthritis; Joint Disease; Osteoarthritis, Knee

Summary:

      This study will evaluate the safety and tolerability of KA34 when administered via
      intra-articular injection to subjects with osteoarthritis of the knee.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of localized osteoarthritis of the knee

          -  Males willing to use contraception and females who are no longer able to bear children

        Exclusion Criteria:

          -  Body Mass Index (BMI) > 40

          -  Grade 0, 3 or 4 osteoarthritis on the Kellgren and Lawrence classification system

          -  Injury to the knee or other joint within the last 12 months

          -  Receipt of any investigational product or experimental therapeutic procedure within
             the last 12 weeks
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PF-06882961 in Japanese Adults With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Placebo; PF-06882961
Intervention description: 3 matching placebo tablets taken twice a day (BID); Participants will be randomized to one of 3 active doses (40, 80, or 120 mg), taking 3 tablets twice daily for 8 weeks.
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 37.0
Sex: All
Minimum age: 20 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      This is a Phase 1, randomized, double blind (sponsor open), parallel, placebo controlled,
      twice daily oral dosing study of PF 06882961 in adult Japanese participants with T2DM
      inadequately controlled on diet and exercise alone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with T2DM who are treated with diet and exercise

          -  HbA1c greater than or equal to 7% and less than or equal to 10.5%

          -  Total body weight >50 kg (110 lb) with BMI 22.5 to 45.4 kg/m^2

        Exclusion Criteria:

          -  Any condition possibly affecting drug absorption

          -  Diagnosis of Type 1 diabetes

          -  History of myocardial infarction, unstable angina, arterial revascularization, stroke,
             heart failure, or transient ischemic attack within 6 months of screening

          -  Any malignancy not considered cured

          -  Personal or family history of MTC or MEN2, or participants with suspected MTC

          -  Acute pancreatitis or history of chronic pancreatitis

          -  Symptomatic gallbladder disease

          -  Known medical history of active proliferative retinopathy and/or macular edema

          -  Known history of HIV, hepatitis B, hepatitis C or syphilis

          -  Supine blood pressure greater than or equal to 160 mmHg (systolic) or greater than or
             equal to 100 mmHg (diastolic)

          -  Clinically relevant ECG abnormalities

          -  Positive urine drug test
Woebot for Substance Use Disorders
Condition: Substance Use Disorders
MeSH terms: Substance-Related Disorders
Intervention: Woebot-SUDs (W-SUDs)
Intervention description: Woebot-SUDs (W-SUDS), an artificially intelligence-powered conversational agent on a smartphone app, eliminates most current SUDs treatment barriers while simultaneously leveraging technology to enhance user experience and engagement. W-SUDs expands and refines existing SUDs treatments by adapting skills from cognitive behavioral therapy, motivational interviewing, and dialectical behavior therapy.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 101.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      Phase 1 of this study aims to develop a digitally-delivered substance use disorder program
      through the Woebot app-based platform (W-SUDs) and evaluate the effectiveness of, patient
      satisfaction with and the acceptability of W-SUDs as a substance use management tool.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All genders

          -  18-65 years

          -  Must have access to a smartphone and able to download the W-SUDs app

          -  Committed to engage with app and complete assessments

          -  Be willing to provide email address (to distribute incentives)

          -  Be literate in English (as W-SUDs conversational and video materials will be in
             English)

          -  Endorse a substance use concern according to the DAST-10 and/or AUDIT-C scale cutoffs
             for problematic use

        Exclusion Criteria:

          -  Pregnancy (as W-SUDs will not be specifically developed to address the unique needs of
             this population)

          -  Suicide attempt or within the past year

          -  Drug or alcohol overdose within the past year
A Safety Study Evaluating N6022 in Multiple-Ascending Doses in Healthy Subjects
Condition: Healthy
Intervention: 5 mg/N6022; Placebo; 10mg/N6022; 20mg/N6022
Intervention description: Intravenous formulation, given at doses of 5 mg once each day over 7 days.; Same administration procedures as active; Intravenous formulation given at doses of 10 mg once each day over 7 days.; Intravenous formulation given at doses of 20 mg once each day over 7 days.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: N6022, GSNORi

Summary:

      This Phase 1 study will evaluate multiple doses across a range that has been found to be
      effective in mouse models of asthma and safe in one Phase 1 clinical trial. It is intended to
      provide evidence of the tolerability of multiple doses as well as provide information on the
      Pharmacokinetic (PK) and metabolism of N6022 in humans.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subject is healthy, determined by pre-study medical evaluation (medical history,
             physical examination, vital signs, 12-lead ECG, and clinical laboratory evaluations

          2. Subject is a non-smoker (or other nicotine user) as determined by history (no nicotine
             use over the past year) and a negative urine cotinine test at screening and Day 1.

          3. Subject has a body weight > 50 kg and BMI between 19.5 and 29.5 kg/m2, inclusive, at
             screening.

          4. Subject has systolic BP > 90 mmHg and diastolic BP > 50 mmHg at screening or Day-1.

        Exclusion Criteria:

          1. Subject has clinically significant history or evidence of cardiovascular, respiratory,
             hepatic, renal, gastrointestinal, endocrine, neurological, immunological, or
             psychiatric disorder(s) as determined by the investigator or designee.

          2. Subject is a current alcohol abuser and/or has a history of illicit drug abuse within
             six months of entry.

          3. Subject has donated blood (> 500 mL) or blood products within 56 days prior to Day -1.

          4. Subject has a history of bleeding disorders (i.e., severe hemorrhage, melena, rectal
             bleeding, nosebleeds, bruising, etc.).
A Study to Compare Subcutaneous Versus Intravenous MabThera (Rituximab) in Combination With Chemotherapy in Patients With Chronic Lymphocytic Leukemia
Condition: Lymphocytic Leukemia, Chronic
MeSH terms: Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Intervention: Cyclophosphamide; Fludarabine; rituximab [MabThera]; rituximab [MabThera]; rituximab [MabThera]
Intervention description: Days 1-3 or Days 1-5 of cycles 1-6; Days 1-3 or Days 1-5 of cycles 1-6; One cycle of intravenous MabThera, followed by 5 cycles of subcutaneous MabThera; After 4 cycles of intravenous MabThera without experiencing grade 3 or 4 infusion-related reactions. patients will receive 1 additional cycle of intravenous MabThera and 1 cycle of subcutaneous MabThera.; 6 cycles of intravenous MabThera
Intervention MeSH terms: Cyclophosphamide; Rituximab; Fludarabine
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 240.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This randomized, parallel-group, multi-center study will compare the pharmacokinetics and
      safety of subcutaneous administration of MabThera (rituximab) versus intravenous MabThera in
      combination with chemotherapy in previously untreated patients with chronic lymphocytic
      leukemia (CLL). The study consists of 2 parts. In part 1, patients who have previously
      received 4 cycles of intravenous MabThera will receive in Cycle 5 intravenous MabThera and in
      Cycle 6 subcutaneous MabThera. In part 2, patients will be randomized to receive either 6
      cycles of intravenous MabThera, or 1 cycle of intravenous MabThera and 5 cycles of
      subcutaneous MabThera. Additionally, all patients will receive chemotherapy (fludarabine and
      cyclophosphamide) on Days 1-3 or Days 1-5 of every cycle. The anticipated time on study drug
      is 24 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients, >/=18 years of age

          -  Patients with treatment-requiring chronic lymphocytic leukemia (CLL)

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0-1

          -  Life expectancy >6 months

        Exclusion Criteria:

          -  Transformation to aggressive B-cell malignancy

          -  History of other malignancy unless the patient was treated with curative intent and
             has been in remission for more than 5 years prior to enrolment

          -  HIV or Hepatitis B positive unless clearly due to vaccination

          -  Inadequate liver or renal function

          -  Any coexisting medical or psychological condition that would preclude participation in
             the required study procedures

        Additional exclusion criterion for Part 1:

          -  Any previous treatment for CLL except for up to 4 cycles of rituximab IV in
             combination with FC chemotherapy as first-line treatment for CLL

        Additional exclusion criterion for Part 2:

          -  Any previous treatment for CLL
Phase I Study of Intravenous Lipotecan® (TLC388 HCl for Injection) in Patients With Advanced Solid Tumors
Condition: Advanced Solid Tumors
MeSH terms: Neoplasms
Intervention: Lipotecan
Intervention description: Lipotecan IV day 1, 8, 15
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 54.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to find a safe and tolerable dose of Lipotecan® when
      administered to patients with advanced solid tumors.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients defined by age ≥18 years.

          -  Pathologically confirmed advanced solid tumors for which standard therapy proven to
             provide clinical benefit does not exist or is no longer effective

          -  Evaluable disease, either measurable on imaging or with informative tumor marker(s),
             by RECIST (Response Evaluation Criteria in Solid Tumors) criteria.

        Exclusion Criteria:

          -  Pregnancy or lactation. Women of childbearing potential must have a negative pregnancy
             test within 7 days prior to enrolment. Male and female patients of childbearing
             potential must agree to use appropriate birth control (barrier methods with
             spermicides, oral or parenteral contraceptives and/or intrauterine devices) during the
             entire duration of the study, or the patient must be surgically sterile (with
             documentation in the patient's medical records).

          -  Previous malignancy, except for non-basal-cell carcinoma of skin or carcinoma-in-situ
             of the uterine cervix, unless the tumor was treated with curative intent more than 2
             years prior to study entry.

          -  Receipt of more than 3 prior regimens of chemotherapy.

          -  Chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C)
             prior to baseline. Receipt of radiotherapy to >25 % of bone marrow. Major surgery
             within 4 weeks prior to baseline.

          -  Concomitant treatment with, or anticipated use of, pharmaceutical or herbal agents
             which are potent inhibitors or inducers of cytochrome P450 enzymes unless approved by
             the Sponsor.

          -  Uncontrolled intercurrent illness that would jeopardize patient safety, interfere with
             the objectives of the protocol, or limit patient compliance with study requirements,
             as determined by the Investigator.
Injection of Local Anesthetic to Trocar Insertion Sites After Laparoscopy
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Intervention: Bupivacaine
Intervention description: Bupivacaine (0.25%) will be injected through the closed trocar incisions after completion of the laparoscopic hysterectomy case.
Intervention MeSH terms: Bupivacaine
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 135.0
Sex: Female
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Local; Anesthesia; Pain; Laparoscopic hysterectomy; Trocar site; Port site

Summary:

      The primary objective of this study is to assess if injection of local anesthetic to the
      laparoscopic trocar sites after a hysterectomy will make a difference in a patient's pain
      after surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who are scheduled for a laparoscopic hysterectomy for benign indications at
             the Department of Obstetrics & Gynecology's Division of Minimally Invasive Surgery at
             Milton S. Hershey Medical Center will be included.

        Exclusion Criteria:

          -  Patients who are scheduled for a hysterectomy through the vaginal or abdominal
             approach will be excluded. Patients with preoperative indications of endometriosis or
             chronic pelvic pain will also be excluded since these patients could potentially have
             higher thresholds of pain.
A Study of Galcanezumab (LY2951742) in Healthy Chinese Participants
Condition: Healthy
Intervention: Galcanezumab; Placebo
Intervention description: Administered SC; Administered SC
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to assess how fast galcanezumab gets into the blood stream and
      how long it takes the body to remove it. Information about side effects will be collected.
      The study is open to healthy Chinese participants. It will last up to about 24 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants who are native Chinese (all 4 biological grandparents and both biological
             parents to be of Chinese origin)

          -  Participants who are overtly healthy males or females, as determined by medical
             history and physical examination

        Exclusion Criteria:

          -  Participants who are currently enrolled in a clinical study involving an
             investigational product or any other type of medical research judged not to be
             scientifically or medically compatible with this study

          -  Participants who have participated, within the last 30 days, in a clinical study
             involving an investigational product. If the previous investigational product has a
             long half-life, 5 half-lives or 30 days (whichever is longer) should have passed

          -  Participants who have received treatment with any CGRP (calcitonin gene related
             peptide) antibody (including galcanezumab), or antibody against CGRP receptor
             (including erenumab), or have received biologic agents (such as monoclonal antibodies)
             within 4 months or 5 half-lives (whichever is longer) prior to dosing

          -  Participants who have a history of multiple or severe allergies or has had an
             anaphylactic reaction to prescription or non-prescription drugs or food

          -  women who are lactating

          -  Participants who show evidence of positive human immunodeficiency virus antibodies, or
             positive hepatitis C antibody, or positive hepatitis B surface antigen, or active
             tuberculosis
Bioavailability Study Comparing 10 mg Amlodipine Besylate Orally Disintegrating Tablets (ODT) And 10 mg Amlodipine Besylate Capsules
Condition: Healthy Volunteers
Intervention: Amlodipine - reference; Amlodipine ODT - test
Intervention description: Amlodipine capsule, 10 mg, single dose, with water; Amlodipine orally disintegrating tablet (ODT), 10 mg, single dose, without water
Intervention MeSH terms: Amlodipine
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: biological availability; bioavailability; amlodipine; orally disintegrating tablet; ODT; tablets

Summary:

      This study is being performed to determine the bioavailability, or extent of absorption into
      the body, of a 10 mg amlodipine besylate orally disintegrating tablet (ODT) as compared to
      the bioavailability of a 10 mg amlodipine besylate capsule.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy male and/or female literate subjects (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 26.4 kg/m2; and a total body weight >50 kg (110 lbs).

        Exclusion Criteria:

          -  Evidence or history of clinically significant hematological, renal, endocrine,
             pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or
             allergic disease (including drug allergies, but excluding untreated, asymptomatic,
             seasonal allergies at time of dosing).

          -  A positive urine drug screen.