bioihbjkbjnl/mcl2 huggingface dataset:
PED NEONAT 20-000599 Fetal Body Composition
Condition: IUGR; Gestational Diabetes; Pregnancy Related
MeSH terms: Diabetes, Gestational
Intervention: 3T "Free-Breathing" Fetal Magnetic Resonance Imaging
Intervention description: Subject will have a one time MRI scan.
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Pregnant mothers who's infants were diagnosed with intrauterine growth restriction and mothers with pregnancies complicated by gestational diabetes, and mothers with healthy uncomplicated pregnancies will be recruited to have a fetal MRI in the third trimester.
Masking: None (Open Label)
Enrollment: 23.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Obesity is an ongoing public health problem that is difficult to treat. There is evidence
      that obesity has fetal origins. Body composition, including visceral, subcutaneous, brown,
      and hepatic fat have been found to be important predictors in obesity and metabolic syndrome.
      Magnetic resonance imaging (MRI) can quantify body composition that does not require
      radiation but is motion limited. The investigators have developed a motion-compensated MRI
      sequence, also known as "free breathing" MRI. In this study, the investigators plan to obtain
      free-breathing MRIs of pregnant women in the third trimester of pregnancy. MRIs will be
      obtained from healthy mothers, mothers with growth-restricted fetuses, and mothers with
      gestational diabetes. The different types of adipose tissue will be measured and compared
      between groups and correlated to birth growth parameters. The goal is this study is to assess
      if motion-compensated MRI can help predict early growth patterns in infancy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pregnant women with singleton pregnancies (healthy cohort)

          -  Pregnant women with fetuses with weights < 10th percentile weight for gestational age
             (IUGR cohort)

          -  Pregnant women with gestational diabetes (diabetes cohort)

        Exclusion Criteria:

          -  Pregnant minors

          -  Major congenital anomalies or disease processes in the fetus

          -  Fetus with known chromosomal anomalies

          -  Mothers who do not plan to deliver at UCLA

          -  Multiple pregnancy (i.e. twins, triplets, etc)

          -  History of claustrophobia

          -  Contraindications to MRI such as metallic devices in the body that are not MRI
             compatible
Safety and Tolerability of Seroguard Use
Condition: Adhesion
MeSH terms: Tissue Adhesions
Intervention: Seroguard; Placebos
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: laparoscopic cholecystectomy
Masking: Double (Participant, Investigator)
Masking description: The present study was planned as double-blind, placebo-controlled study. With the aim of maximum objectification of end point, neither Medical Investigator, nor patients had access to the code of healthcare institution.
The test drug or the placebo were received by the sites as ready for use and blinded vials, 200 mL each. Each vial had individual number and identification of contents ("Drug A" or "Drug B"). Conformity of identification of Seroguard or the placebo was not disclosed to the sites.
Before surgery, the Medical Investigator prepared required number of vials according to identification of the drug on the vial and identification of the group in randomization envelope of patient. Individual number of each vial administered to a patient was recorded in documentation of site.
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Adhesion; Safety

Summary:

      The performed study of safety and tolerability of Seroguard, solution (JSC Pharmasyntez,
      Russia) in patients, undergoing planned laparoscopic cholecystectomy, demonstrated that
      patients from the both groups had the similar safety profile
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male and female patients.

          2. Age from 18 to 75 years, inclusive.

          3. Signed informed consent form.

          4. One of the following diagnoses as per International classification of diseases -10:

             4.1. K80.1 Calculus of gallbladder with other cholecystitis 4.2. K80.2 Calculus of
             gallbladder without cholecystitis

          5. Indications for planned laparoscopic cholecystectomy.

        Exclusion Criteria:

          1. Recall of informed consent by patient.

          2. Non-compliance with the rules of participating in the study by patient.

          3. Getting pregnant.

          4. Required conversion during surgery.

          5. Required repeated surgery.

          6. Development of diseases described in non-inclusion criteria, required use of drugs not
             provided by the protocol in patient.

          7. Another reasons appeared during the study and interfering conduction of the study as
             per the protocol.
Buspirone as a Candidate Medication for Methamphetamine Abuse
Condition: Methamphetamine Dependence; Methamphetamine Abuse
Intervention: Methamphetamine; Placebo
Intervention description: The pharmacodynamic effects of methamphetamine will be determined during placebo and buspirone maintenance.; The pharmacodynamic effects of placebo methamphetamine will be determined during placebo and buspirone maintenance.
Intervention MeSH terms: Methamphetamine
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 9.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Methamphetamine use disorders are an unrelenting public health concern. Intensive research
      efforts have yielded behavioral interventions that reduce methamphetamine use, however, these
      interventions are not universally effective and treatment effects diminish over time.
      Development of a pharmacotherapy that enhances the efficacy of these interventions is a
      priority for the National Institute on Drug Abuse. This study proposes to determine the
      impact of buspirone maintenance on self-administration of methamphetamine. These preliminary
      data will be used to support further research developing buspirone as a pharmacotherapy for
      methamphetamine use disorders. The investigators hypothesize that buspirone will attenuate
      the reinforcing effects of methamphetamine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Lifetime methamphetamine use

        Exclusion Criteria:

          -  Abnormal screening outcome (e.g., ECG, blood chemistry result) that study physicians
             deem clinically significant

          -  Current or past histories of substance abuse or dependence that are deemed by the
             study physicians to interfere with study completion

          -  History of serious physical disease, current physical disease, impaired cardiovascular
             functioning, chronic obstructive pulmonary disease, history of seizure or current or
             past histories of serious psychiatric disorder that in the opinion of the study
             physician would interfere with study participation will be excluded from participation

          -  Females not currently using effective birth control

          -  Contraindications to methamphetamine or buspirone
A Study of an Investigational V212/Heat-Treated Varicella-Zoster Virus (VZV) Vaccine in Immunocompromised Adults (V212-002)
Condition: Herpes Zoster; Herpes Zoster-related Complications
MeSH terms: Herpes Simplex; Herpes Zoster; Chickenpox
Intervention: V212; Placebo
Intervention description: 0.65 ml V212 in 4 dose regimen. Treatment period of 125 days; 0.65 ml V212 Pbo in 4 dose regimen. Treatment period of 125 days
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 341.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Prevention of herpes zoster and HZ-related complications

Summary:

      This study will evaluate the safety and immunogenicity of a heat-treated VZV vaccine in
      autologous or allogeneic hematopoietic cell transplant (HCT) recipients, human
      immunodeficiency virus (HIV)-infected participants with a baseline cluster of differentiation
      4 (CD4) cell count ≤200 cells/mm^3, participants with solid tumor malignancy (STM; breast,
      colorectal, lung, or ovarian malignancies) receiving chemotherapy, and participants with
      hematologic malignancy (HM; leukemia or leukemia-like disease, lymphoma or lymphoma-like
      disease, or multiple myeloma). The primary hypothesis is that the heat-treated VZV vaccine
      will elicit significant VZV-specific immune responses measured by either glycoprotein-based
      enzyme-linked immunosorbent assay (gpELISA) or VZV gamma interferon enzyme-linked immunospot
      (IFN-ELISPOT) at 28 days post dose vaccination 4 in, HIV-infected participants, participants
      with STM, and participants with HM. The primary immunogenicity objective and endpoints were
      considered by the protocol as exploratory for the autologous and allogeneic HCT groups.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and women > or = to 18 years of age who are scheduled to receive an autologous or
             allogeneic hematopoietic cell transplant within 60 days of enrollment

          -  HIV-infected participants with a baseline CD4 cell count < or = to 200 cells/mm^3

          -  Participants with hematologic malignancies; or participants who are receiving
             chemotherapy for breast, colorectal, lung, or ovarian malignancies

        Exclusion Criteria:

          -  History of allergy to any vaccine component

          -  Prior history of HZ

          -  Prior history of receipt of any varicella or zoster vaccine
Methodology Study To Examine 6-Week Food Intake With Liraglutide In Obese Subjects
Condition: Obesity
Intervention: Liraglutide; Placebo
Intervention description: Liraglutide; Placebo
Intervention MeSH terms: Liraglutide
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 61.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This will be a randomized, double blind, placebo controlled, 2 arm, parallel group,
      methodology study to assess the effect of 6 weeks of liraglutide administration on food
      intake in obese subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and female subjects;

          -  Body Mass Index 30-40 kg/m2;

        Exclusion Criteria:

          -  Evidence of history of clinically significant hematological, renal, endocrine,
             pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or
             allergic disease (including drug allergises, but excluding untreated, asymptomatic,
             seasonal allergies at time of dosing)
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
Transcoronary Infusion of Cardiac Progenitor Cells in Pediatric Dilated Cardiomyopathy
Condition: Dilated Cardiomyopathy
MeSH terms: Cardiomyopathies; Cardiomyopathy, Dilated
Intervention: CDC infusion
Intervention description: Injection of CDCs (0.3 million per kg of body weight).
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Transcoronary infusion
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      A phase 1 prospective study to determine the procedural feasibility and safety and
      preliminary efficacy of intracoronary infusion of cardiosphere-derived cells (CDCs) in
      patients with dilated cardiomyopathy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients diagnosed as dilated cardiomyopathy.

          -  Patients aged under 18 years old.

          -  Cardiac ejection fraction < 40%.

        Exclusion Criteria:

          -  Contradiction to cardiac magnetic resonance imaging.

          -  Cardiogenic shock.

          -  A patient with unstoppable extracorporeal circulation.

          -  A patient with lethal, uncontrollable arrhythmia.

          -  A patient with a complication of coronary artery disease.

          -  A patient with a complication of brain dysfunction due to circulatory failure.

          -  A patient with malignant neoplasm.

          -  A patient with a complication of a serious neurologic disorder.

          -  A patient with high-grade pulmonary embolism or pulmonary hypertension.

          -  A patient with high-grade renal failure.

          -  A patient with multiple organ failure.

          -  Active infection (including endocarditis).

          -  Sepsis.

          -  Active hemorrhagic disease (e.g. gastrointestinal bleeding, injury).
A Study to Investigate the Safety and Effect of the Study Drug (FE 204205) in Patients With Cirrhotic Portal Hypertension
Condition: Portal Hypertension
MeSH terms: Hypertension, Portal; Hypertension
Intervention: FE 204205; Placebo
Intervention description: In Part 1 of the trial, each subject will receive increasing IV doses of FE 204205, given once daily as 2 hour infusion, on three consecutive days.
In Part 2 of the trial, each subject will receive a 2 hour IV infusion of the maximum tolerated dose of FE 204205 as defined in Part 1 of the trial.; In Part 2 of the trial, each subject will receive a 2 hour IV infusion of placebo.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 4.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The purpose of this trial is to investigate safety, tolerability, pharmacodynamics (PD), and
      pharmacokinetics (PK) after intravenous (IV) administration of FE 204205 in patients with
      cirrhotic portal hypertension.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed evidence of cirrhosis

          -  From medical history anticipated hepatic venous pressure gradient greater than equal
             to (≥)12 mmHg

        Exclusion Criteria:

          -  Co-existing disease e.g. significant organ failure and decompensated cirrhosis

          -  Type 1 hepatorenal syndrome

          -  Acute-on-chronic liver failure

          -  Hepatic encephalopathy ≥grade 2

          -  Hepatocellular carcinoma

          -  History of underlying chronic heart disease

          -  Use of vasopressin or terlipressin within 7 days prior to dosing
Study of Milademetan in Japanese Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML)
Condition: Acute Myeloid Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Intervention: Milademetan
Intervention description: Milademetan was administered orally once daily on Days 1 to 14 in a 28-day cycle.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Oncology; MDM2; Escalation with overdose control (EWOC)

Summary:

      This is a Phase 1, multicenter, open-label study to evaluate safety, tolerability and
      pharmacokinetics of milademetan in Japanese patients with relapsed or refractory acute
      myeloid leukemia. The milademetan initial dose will be Level 1: 90 mg. No increase in the
      milademetan dose will be made in the same participant. Dose-limiting toxicity associated with
      milademetan occurring at each level will be assessed, and the maximum tolerated dose (MTD)
      will be decided using a modified continuous reassessment method (mCRM).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Relapsed or refractory AML

          -  AML for which no standard treatment is available

          -  Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 to 2

        Exclusion Criteria:

          -  Acute Promyelocytic Leukemia

          -  Chronic myelogenous leukemia in blast crisis (BCR-ABL fusion gene positive)

          -  Presence of central nervous system involvement of leukemia or a history of primary
             central nervous system leukemia
AMG 529 First in Human Study
Condition: Cardiovascular
Intervention: AMG 529; Placebo
Intervention description: Ascending single doses of AMG 529 by subcutaneous (SC) or intravenous (IV) injection; Single doses of matching placebo by SC or IV injection
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Within each dose cohort participants were randomized in a 3:1 ratio to receive either AMG 529 or placebo.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 48.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      A study to assess the safety and tolerability of AMG 529 following single, ascending doses
      administered subcutaneously (SC) or intravenously (IV) in healthy adults.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Healthy men and women ≥ 18 to ≤ 55 years old with no history or evidence of clinically
             relevant medical disorders

          2. Body mass index (BMI) between 18 and 32 kg/m², inclusive, at screening

          3. Women must be of non-reproductive potential as defined in protocol

          4. Other inclusion criteria may apply

        Exclusion Criteria:

          1. Currently receiving treatment in another investigational device or drug study, or less
             than 30 days or 5 half-lives (whichever is longer), since ending treatment on another
             investigational device or drug study(s) prior to receiving the first dose of
             investigational product

          2. Women who are lactating/breastfeeding or who plan to breastfeed while on study through
             90 days after receiving the dose of investigational product

          3. Men with partners who are pregnant or planning to become pregnant while the subject is
             on study through 90 days after receiving the dose of investigational product

          4. Positive pregnancy test at screening or day -1

          5. Other exclusion criteria may apply