bioihbjkbjnl/mcl2 huggingface dataset:
A Study of the Safety and Pharmacokinetics of Apixaban Versus Vitamin K Antagonist (VKA) or Low Molecular Weight Heparin (LMWH) in Pediatric Subjects With Congenital or Acquired Heart Disease Requiring Anticoagulation
Condition: Thrombosis
MeSH terms: Heart Diseases; Thrombosis
Intervention: Apixaban; Vitamin K Antagonist (VKA); Low Molecular Weight Heparin (LMWH)
Intervention description: Specified dose on specified days; Specified dose on specified days; Specified dose on specified days
Intervention MeSH terms: Vitamin K; Heparin; Enoxaparin; Heparin, Low-Molecular-Weight; Tinzaparin; Dalteparin; Warfarin; Apixaban
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 192.0
Sex: All
Minimum age: 28 Days
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      To investigate the safety and pharmacokinetics of apixaban in children with congenital or
      acquired heart disease who have a need for anticoagulation.
    

Eligibility criteria:

        For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
        visit www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Males and Females, 28 days to < 18 years of age, inclusive

          -  Congenital or acquired heart diseases requiring chronic anticoagulation for
             thromboprophylaxis (eg, single ventricle physiology including all 3 stages of
             palliation, dilated cardiomyopathy, Kawasaki disease with coronary aneurysms, and
             pulmonary hypertension)

          -  Eligible participants include those who newly start anticoagulants and those who are
             currently on VKA or LMWH or other anticoagulants for thromboprophylaxis

          -  Able to tolerate enteral medication [eg, by mouth, nasogastric tube, or gastric tube]

          -  Participants 28 days to < 3 months must be able to tolerate oral/nasogastric tube
             (NGT)/gastric tube (GT) feeds for at least 5 days prior to randomization

        Exclusion Criteria:

          -  Recent thromboembolic events less than 6 months prior to enrollment

          -  Weight < 3 kg

          -  Use of aggressive life-saving therapies such as ventricular assist devices (VAD) or
             extracorporeal membrane oxygenation (ECMO) at the time of enrollment

          -  Artificial heart valves and mechanical heart valves

          -  Known inherited bleeding disorder or coagulopathy (e.g. hemophilia, von Willebrand
             disease, etc.)

          -  Active bleeding at the time of enrollment

          -  Any major bleeding other than perioperative in the preceding 3 months

          -  Known intracranial congenital vascular malformation or tumor

          -  Confirmed diagnosis of a GI ulcer

          -  Known antiphospholipid syndrome (APS).

        Other protocol defined inclusion/exclusion criteria apply
Long-Term Safety Of PF-00547659 In Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Intervention: 75mg SHP647 (PF-00547659); 225mg SHP647 (PF-00547659)
Intervention description: 75 mg sterile liquid injected subcutaneously every 4 weeks.; 225 mg sterile liquid injected subcutaneously every 4 weeks.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 330.0
Sex: All
Minimum age: 18 Years
Maximum age: 66 Years
Healthy volunteers: No
Keywords: Anti-TNF Refractory; Active Ulcerative Colitis; Immunosuppressant Refractory

Summary:

      Subjects with Ulcerative Colitis who have completed an induction study with PF-00547659 will
      receive an additional 144 weeks of open-label treatment to evaluate the long-term safety of
      the drug.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects between 18 and 66 years of age.

          -  Subjects previously enrolled in study A7281009 (NCT01620255) who have completed the 84
             day (12 week) induction period.

        Exclusion Criteria:

          -  Subjects that have completed Day 84 (Week 12) of study A7281009 but have experienced
             serious event(s) related to the investigational product, an unstable medical
             condition, or any other reason, in the opinion of the investigator, would preclude
             entry or participation in this study.

          -  Subjects who are taking any dose of Azathioprine (AZA), 6-mercaptopurine(6 MP) or
             Methotrexate (MTX).
Effects of Low-dose Naltrexone in Combination With a Range of Smoked Marijuana
Condition: Marijuana Smoking
MeSH terms: Marijuana Abuse; Marijuana Use
Intervention: Inactive Marijuana (0% THC); Active Marijuana (5.5% THC); Active Marijuana (6.2% THC); Naltrexone; Placebo naltrexone
Intervention description: Marijuana cigarette containing 0% THC; Marijuana cigarette containing 5.5% THC; Marijuana cigarette containing 6.2% THC; Naltrexone (12mg/70kg); Naltrexone (0mg)
Intervention MeSH terms: Naltrexone
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Masking description: Double-blind, placebo-controlled
Enrollment: 23.0
Sex: All
Minimum age: 21 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: naltrexone; smoked marijuana; marijuana use

Summary:

      In heavy marijuana smokers, opioid receptor blockade increases the subjective and
      cardiovascular effects of marijuana. The current study was designed to clarify
      opioid-cannabinoid interactions by assessing how naltrexone shifts the dose-response function
      for marijuana-elicited effects in heavy marijuana smokers. For this within-subject,
      double-blind study, a marijuana smoking procedure was designed to characterize a
      dose-response relationship for marijuana's subjective and cardiovascular effects under
      blinded conditions.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Current marijuana use

          -  Able to perform study procedures

          -  Women practicing an effective form of birth control

        Exclusion Criteria:

          -  Current repeated illicit drug use (other than marijuana)

          -  Presence of significant medical illness (e.g., diabetes, cardiovascular
             disease,hypertension, hepatitis, clinically significant laboratory abnormalities, LFTs
             > 3x upper limit of normal, blood pressure > 140/90
Study of Various Treatments in Non-alcoholic Fatty Liver Disease (NAFLD) Patients Who Have Aspects of Non-alcoholic Steatohepatitis (NASH)
Condition: Non-alcoholic Fatty Liver Disease; Nonalcoholic Steatohepatitis
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Intervention: LYS006; Tropifexor
Intervention description: 5 mg LYS006 capsules orally administered 20 mg b.i.d for 12 weeks; 100 ug LJN452 capsules orally administered 200ug once daily for 12 weeks
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 41.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Non-alcoholic fatty liver disease; NAFLD; Non-alcoholic steatohepatitis; NASH; Platform design; LYS006; LJN452; Tropifexor

Summary:

      This clinical study was designed to evaluate the safety, tolerability, pharmacokinetics and
      efficacy of various single and combination treatments in adult patients with non-alcoholic
      fatty liver disease (NAFLD) who manifest a non-alcoholic steatohepatitis (NASH)-like
      biomarker phenotype.
    

Eligibility criteria:

        Inclusion Criteria:

        Phenotypic diagnosis of NASH based on the presence of all of the following:

          -  ALT ≥ 43 IU/L (males) or ≥ 28 IU/L (females)

          -  BMI ≥ 27 kg/m2 (race other than Asian) or ≥ 23 kg/m2 (Asian race)

          -  History of type 2 diabetes mellitus with HbA1c ≤ 9%

          -  ELF test score ≥ 8.5 and ≤ 10.5

          -  Liver fat ≥ 8%

          -  Patients must weigh between 40 kg (88 lbs.) and 150 kg (330 lbs.)

        Exclusion Criteria:

          -  Use of other investigational drugs within 5 half-lives of randomization or within 3
             months, whichever is longer

          -  Use of obeticholic acid (OCA) or pharmacologically-active weight loss drugs within 1
             month of randomization

          -  Use of strong CYP3A4/5 inhibitors or strong CYP3A4 inducers within 5 half-lives or 7
             days of randomization, whichever is longer

          -  History or presence of other concomitant liver diseases

          -  History or current diagnosis of ECG abnormalities

          -  Patients with contraindications to MRI imaging

          -  Current or history of significant alcohol consumption

          -  Clinical evidence of hepatic decompensation or severe liver impairment

          -  Women of child bearing potential (unless on highly effective methods of contraception)

          -  Presence of liver cirrhosis

          -  Use of OAT3 inhibitors within 5 half-lives or 7 days of randomization, whichever is
             longer
Intra-operative Application of HEMOPATCH to the Pancreatic Stump to Prevent Post-operative Pancreatic Fistula Following Distal Pancreatectomy
Condition: Pancreas Cancer; Pancreas Disease; Pancreas Adenocarcinoma; Pancreas; Fistula; Surgery; Surgery--Complications; Surgery Site Fistula
MeSH terms: Pancreatic Neoplasms; Pancreatic Fistula; Pancreatic Diseases; Fistula
Intervention: Hemopatch
Intervention description: Application of hemopatch to the divided end of the pancreas during surgery.
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 52.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hemopatch

Summary:

      Despite improvements and advances in pancreas surgery, about 30-35% of patients who have
      pancreas surgery develop a type of complication called a pancreatic fistula. A pancreatic
      fistula occurs when fluid produced by the pancreas leaks into the abdomen after pancreas
      surgery. Patients who develop a pancreatic fistula can have poor short-term and long-term
      consequences.We are studying the effect of a medical device named HEMOPATCH on the
      development and seriousness of pancreatic fistulas. HEMOPATCH is a thin, flexible bovine
      protein-based pad that may improve tissue sealing where it is applied during surgery. Some
      small studies called case studies of between 2 and 7 patients, and two clinical trials have
      shown that HEMOPATCH is effective at stopping bleeding and reducing drain output after some
      types of surgery. However, there have been no completed clinical trials using HEMOPATCH to
      prevent or reduce pancreatic fistulas in patients having pancreas surgery, so we don't know
      if it works in this setting. Health Canada has approved the use of HEMOPATCH as a device to
      stop bleeding or seal other bodily fluids for procedures in which the control of bleeding or
      leakage of other body fluids or air by standard surgical techniques are either ineffective or
      impractical.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Scheduled to undergo distal pancreatectomy surgery that is open or laparoscopic, with
             or without splenectomy

          -  Age ≥ 18 years

          -  Able and willing to comply with study procedures and follow-up examinations contained
             within the written consent form

        Exclusion Criteria:

          -  Contraindication to placement of HEMOPATCH tissue sealant including: 1) Known
             hypersensitivity to bovine proteins; 2) Known hypersensitivity to brilliant blue [FD&C
             Blue No.1 (Blue 1)]; 3) Presence of an active infection; and 4) Known pregnancy or
             lactation (a negative urine pregnancy test must be obtained for women of child bearing
             potential during the pretreatment evaluation)

          -  Participating in another interventional trial that may result in co-intervention or
             contamination (to be determined by sponsor)
The Use of Tranexamic Acid to Reduce Perioperative Blood Loss During High Risk Spine Fusion Surgery
Condition: Curvature of Spine
MeSH terms: Spinal Curvatures
Intervention: Tranexamic Acid
Intervention description: intravenous administration of bolus and infusion for duration of surgical procedure
Intervention MeSH terms: Tranexamic Acid
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 61.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine if tranexamic acid reduces perioperative blood loss
      and red blood cell transfusion during high risk spine surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  age>17 years

          -  undergoing posterior spine fusion surgery for kyphoscoliosis with a >80% chance of
             major transfusion

        Exclusion Criteria:

          -  age < 18 years

          -  non-English speaking

          -  pregnancy

          -  emergency procedures

          -  surgery for tumor, trauma or infection

          -  severe coronary artery disease

          -  history of venous thromboembolism

          -  history of cerebral vascular accident

          -  history of renal insufficiency

          -  allergy to tranexamic acid
Efficacy and Safety Study of SUNPG1623
Condition: Active Psoriatic Arthritis
MeSH terms: Arthritis; Arthritis, Psoriatic
Intervention: SUNPG1623 I; SUNPG1623 II; SUNPG1623 III; SUNPG1623 IV; PLACEBO
Intervention description: injection; injection; injection; injection; injection
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 391.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a randomized, double-blind, placebo-controlled, multiple-dose, phase 2b study to
      demonstrate the safety and efficacy of SUNPG1623
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject has provided written informed consent

          -  Subject is ≥ 18 years of age at time of Screening

          -  Subject must be on stable dose of NSAID for ≥ 4 weeks prior to initiation of IMP

          -  Subject has a negative evaluation for TB within 4 weeks before initiating IMP

          -  Subject has a diagnosis of PsA (by the Classification of Psoriatic Arthritis [CASPAR]
             criteria) with symptoms present for at least 6 months.

          -  Subject has ≥ 3 tender and ≥ 3 swollen joints at Screening and Baseline.

        Exclusion Criteria:

          -  Subject has a planned surgical intervention between Baseline and the Week 24
             evaluation for a pretreatment condition

          -  Subject has an active infection or history of infections

          -  Subject has any concurrent medical condition or uncontrolled, clinically significant
             systemic disease

          -  Subject has a known history of infection with hepatitis B, hepatitis C, or human
             immunodeficiency virus
Platelet-rich Plasma (PRP) for Endometrial Regeneration and Repair
Condition: Infertility; Asherman's Syndrome
MeSH terms: Infertility; Gynatresia
Intervention: Intrauterine infusion of platelet rich plasma
Intervention description: Patients randomized to study group will have 30cc of blood drawn with isolation of platelet rich plasma (PRP) per standard manufacturer's protocol, with subsequent intrauterine infusion of this autologous PRP.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: During Study Period #1: Subjects were randomized to receive either PRP or standard care. A total of 13 subjects were randomized.
The study design was then altered to remove randomization (10/4/2018). All patients in Study Period #2 received PRP. An additional 14 subjects were enrolled in Study Period #2.
Masking: None (Open Label)
Enrollment: 27.0
Sex: Female
Minimum age: 18 Years
Maximum age: 43 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: endometrium; thin uterine lining; uterine scarring

Summary:

      Patients with intrauterine adhesions (Asherman's Syndrome) and persistent thin endometrial
      lining in in vitro fertilization (IVF) treatment programs, particularly those resistant to
      standard therapies, present a significant clinical challenge. The aim of this trial is to
      assess if intrauterine administration of platelet rich plasma (PRP) improves endometrial
      lining thickness in patients with thin lining or Asherman's Syndrome.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Persistent thin lining < 6mm on >1 cycle in previous IVF or FET cycle OR
             moderate-to-severe Asherman's syndrome

        Exclusion Criteria:

          -  Age <18 years old or >43 years old,

          -  Pregnancy,

          -  Diagnosis of cancer,

          -  Hb <11 g/dL, platelets <150,000/mm3,

          -  Anticoagulation,

          -  NSAIDs in the 10 days before procedure

          -  Any significant comorbidity or psychiatric disorder that would compromise patient
             safety or compliance, interfere with consent, study participation, follow up, or
             interpretation of study results.

          -  Incision in the uterus: myomectomy; cesarean section
Study of TER-101 Topical Ointment in Subjects With Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: TER-101; Vehicle
Intervention description: Active Comparator; Placebo Comparator
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 63.0
Sex: All
Minimum age: 12 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This Phase 2 study will assess efficacy, safety, and tolerability of TER-101 ointment and
      vehicle twice daily for 28 days in adult and adolescent subjects with mild to moderate atopic
      dermatitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adolescent or adult subject aged 12 - 65 years.

          -  Overall IGA score of 2 (mild) or 3 (moderate) at baseline on a 5-point IGA

        Exclusion Criteria:

          -  AD with known hypersensitivity to excipients of TER-101 Ointment

          -  Subjects who are immunocompromised
Aprepitant Injectable Emulsion in Patients With COVID-19 (GUARDS-1)
Condition: COVID-19
MeSH terms: COVID-19
Intervention: Aprepitant injectable emulsion; Saline Placebo
Intervention description: Aprepitant injectable emulsion, once daily (QD) for 14 days.; Saline Placebo, once daily (QD) for 14 days.
Intervention MeSH terms: Aprepitant
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 27.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: COVID-19; Coronavirus

Summary:

      The study will evaluate the efficacy and safety of aprepitant injectable emulsion added to
      standard of care for hospitalized patients with COVID-19.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Is hospitalized for ≤48 hours with SARS-CoV-2 infection. Confirmed by polymerase chain
             reaction (PCR), antigen or immunoglobulin M (IgM) antibody test.

          -  Has at least 1 of the following: Radiographic infiltrates by imaging, or oxygen
             saturation of <94% by pulse oximetry on room air or requiring supplemental oxygen.

          -  Not anticipated to require mechanical ventilation within 48 hours.

        Exclusion Criteria:

          -  Is taking high-dose hydroxychloroquine or chloroquine.

          -  Is taking pimozide or strong or moderate CYP3A4 inhibitors.

          -  Is currently receiving treatment with products intended to modify immune response to
             COVID-19 (exception: dexamethasone, methylprednisolone, or equivalent are allowed),
             chemotherapy or on hemodialysis or peritoneal dialysis.

          -  Has known hypersensitivity to any components of aprepitant injectable emulsion.

          -  Has evidence of ARDS.

          -  Is being treated with oxygen delivered by high-flow nasal cannula nonrebreather mask,
             noninvasive positive pressure ventilation, or ECMO.

          -  Has multiple organ failure.

          -  Has current confirmed Influenza A or B infection, or a a history of organ or
             hematologic transplant, HIV, or active hepatitis B or hepatitis C infection.