bioihbjkbjnl/mcl2 huggingface dataset:
Defibrotide in the Human Endotoxemia Model --- an Exploratory Trial Investigating the Effects and the Mechanisms of Defibrotide
Condition: Healthy Volunteers; Endotoxemia
MeSH terms: Endotoxemia
Intervention: Defibrotide; Placebo (0.9% sodium chloride); Lipopolysaccharide; Placebo (0.9% sodium chloride bolus)
Intervention description: 6.25mg/kg bodyweight over 2h infusion; (0.9% sodium chloride) infusion over 2h infusion; bolus infusion of 2ng/kg bodyweight lps; (0.9% sodium chloride) bolus infusion
Intervention MeSH terms: Defibrotide
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Subjects will be randomized to receive LPS (n=16) or placebo (n=4) first. In each group they will undergo two study periods (crossover trial): a placebo period and a defibrotide period. The placebo group (n=4) will only be analyzed descriptively.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Coagulation; Inflammation; Defibrotide; Fibrinolysis

Summary:

      Defibrotide is an anti-inflammatory and anti-coagulatory agent approved for treatment of
      veno-occlusive disease. Although it has been in clinical use for almost 30 years, the exact
      mechanism of action has never been fully elucidated. Thus, the effects of defibrotide will be
      investigated in the human endotoxemia model in order to gather further information on its
      actions.
    

Eligibility criteria:

        Inclusion Criteria:

          -  >18 years of age

          -  <90kg body weight

          -  Normal findings in medical history and physical examination unless the investigator
             considers the abnormality to be clinically irrelevant

          -  Normal laboratory values unless the investigator considers abnormalities to be
             clinically irrelevant

          -  Ability to understand the purpose and nature of the study, as well as the associated
             risks

        Exclusion Criteria:

          -  Intake of any drugs that may interfere with the trial's endpoints or drugs (i.e.
             platelet inhibitors, anticoagulants, etc.)

          -  Positive results of HIV or hepatitis virology

          -  Acute illness with systemic inflammatory reactions

          -  Known allergies, hypersensitivities or intolerances to any of the used substances

          -  Acute or recent bleeding episodes, increased risk of bleeding at the discretion of the
             investigator

          -  Participation in an LPS trial within 6 weeks of the first study day

          -  Pregnancy or breastfeeding
A Clinical Study to Evaluate if Benzalkonium Chloride (BAK) in a Quinolone Eyedrop Reduces the Likelihood of Developing Resistant Organisms
Condition: Anti-biotic Resistance
Intervention: moxifloxacin 0.5% HCI ophthalmic solution; gatifloxacin ophthalmic solution 0.3%
Intervention description: 1 drop in study eye three times a day for 14 days; 1 drop in study eye four times a day for 14 days
Intervention MeSH terms: Moxifloxacin; Gatifloxacin; Pharmaceutical Solutions; Ophthalmic Solutions
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 66.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to assess if the presence of BAK in a fluoroquinolone in the
      study eye affects the development of resistant bacteria on the conjunctiva based upon changes
      in the surface flora over the course of 2 weeks of topical treatment in healthy adult
      subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or Female

          -  At least 50 years of age

          -  In good general health

        Exclusion Criteria:

          -  Any ocular surgery or use of topical antibiotics or antiseptics in either eye within
             the last 3 months

          -  Use of topical steroids, or non-steroidal anti inflammatory drugs in either eye within
             30 days of Baseline (or anticipated during the study)

          -  Use of lid scrubs within 7 days of Baseline in either eye (or anticipated use during
             the study)
Adding an Insulin-Sensitizing Medication to Depression Treatment for People Who Are Depressed and Overweight
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Intervention: Sertraline; Metformin
Intervention description: 50 mg once a day, which may be increased to 200 mg once a day; Starting dose of 500 mg daily and increasing by 500 mg every 2 weeks to a total of 2,000 mg daily
Intervention MeSH terms: Metformin; Sertraline
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 206.0
Sex: All
Minimum age: 20 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Metabolic Diseases; Depressive Disorder, Major; Depressive Disorder; Glucose Metabolism Disorders; Depression Recurrence

Summary:

      This study will determine whether the drug metformin improves the effects of traditional
      antidepressant medications in people who are overweight.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Body mass index (BMI) greater than 28.7

          -  Positive screening for depression

          -  Must live within 100 miles of the St. Louis metropolitan area

        Exclusion Criteria:

          -  Pregnant or breastfeeding

          -  Known hypersensitivity to sertraline or metformin

          -  Recent history of heart attack or unstable heart disease

          -  Severe liver disease or kidney impairment, defined by a serum creatine level above 3
             mg/dL

          -  Psychiatric disorder thought to affect management, such as schizophrenia, or alcohol
             or drug dependence
Genetically Informed Smoking Cessation Trial
Condition: Smoking Cessation
Intervention: Combination NRT (Nicotine patch, Nicotine lozenge); Varenicline; Placebo; Intensive smoking counseling
Intervention MeSH terms: Nicotine; Varenicline
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 822.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Smoking cessation; Counseling; Genetics and Genomics

Summary:

      The investigators' goal is to identify the most appropriate smoking cessation treatments for
      smokers based on genetic information. Smokers try to quit smoking but relapses are common.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Adult (≥21 years of age), seeking treatment for smoking cessation.

          2. Able to speak English,

          3. Active smoking (Cigarettes Per Day (CPD) ≥5), and exhaled Carbon Monoxide (CO) ≥8 ppm

          4. Agree to participate in this randomized smoking cessation trial with follow up
             assessments up to 12 months.

        Exclusion Criteria:

          1. Pregnancy or breast feeding,

          2. Active use or recent use (< or equal to 1 month) of medication or e-cigarettes for
             nicotine dependence/smoking cessation, or use of e-cigarettes for more than 9 days in
             the prior month,

          3. Allergy to nicotine patch, lozenge, or varenicline,

          4. Unwillingness to prevent pregnancy during the medication phase and 1 month afterwards
             (women only),

          5. Significant cardiac conditions (myocardial infarction, unstable angina, coronary
             angioplasty, cardiac bypass) or serious arrhythmia in past 6 months,

          6. Current heavy alcohol consumption (≥6 drinks/day, 6 days/week),

          7. Active psychosis or poorly controlled depression within the past 6 months,

          8. Any prior suicide attempt or suicidal ideation within the past 6 months,

          9. End stage renal disease with hemodialysis.
Ketamine for Acute Pain Management After Trauma
Condition: Trauma Injury; Pain; Opioid Use
MeSH terms: Acute Pain; Wounds and Injuries
Intervention: Ketamine plus usual care; Usual Care
Intervention description: Bolus of .35 mg/kg Infusion start @ 0.15 mg/kg/hr; titrate range is 0.1 - 0.25 mg/kg/hr for 24 to 48 hours after admission and each subsequent major surgery plus multi-modal pain therapy considered as standard of care. Standard of care medications include Acetaminophen 1000 mg po q6 hours, Naproxen 500 mg po q12 hours, Gabapentin 300 mg po q8 hours and Lidocaine patch q 12 hours.; Standard of care medications include Acetaminophen 1000 mg po q6 hours, Naproxen 500 mg po q12 hours, Gabapentin 300 mg po q8 hours and Lidocaine patch q 12 hours.
Intervention MeSH terms: Ketamine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 305.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: No
Keywords: Multimodal Pain Therapy; Ketamine; Trauma

Summary:

      The purpose of this study is to compare the effectiveness of Ketamine drip along with usual
      care and usual care alone on trauma patients and to longitudinally quantify the pain
      experience of patients during hospitalization.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult trauma patients

          -  Admission to Shock Trauma ICU (STICU) or Surgical Intermediate Unit (SIMU)

          -  Randomization within 6 hours of arrival

        Exclusion Criteria:

          -  Patient not expected to survive

          -  Contraindications to ketamine Allergy, Poorly controlled hypertension, Cardiac
             arrhythmia disorders (including atrial fibrillation), congestive heart failure,
             unstable coronary artery disease or recent myocardial infarction( MI)(within 6
             months), cirrhosis, seizure disorder, and for those patients with unknown medical
             history - median sternotomy scar, mechanism of injury is fall from standing, 65 years
             of age or older, any arrhythmia on EKD)

          -  pregnancy

          -  in police custody

          -  history of dementia or movement disorder (i.e. Parkinson's)
SCHEDULE Follow Up Visit 5-7 yr
Condition: Heart Transplantation
Intervention: Everolimus; Cyclosporine; Mycophenolate mofetil; Corticosteroids
Intervention description: All patients, independent of their initial randomization in the core study, were followed up as in one single group
Commercially available everolimus (Certican®), oral route, was used.; Cyclosporine (CsA) control group target blood level: 150-350 ng/mL (month 1-3); 100-250 ng/mL (month 4-6); 60-200 ng/mL (month 7-12); everolimus group target blood level: 75-175 ng/mL (month 1-3); Mycophenolate mofetil (MMF) target dose for control group: 2000-3000 mg/day everolimus group target dose: 1500-2000 mg/day and 75-175 ng/mL after week 11; Corticosteroids (CS) initiated at 0.2-0.5 mg/kg/day. Tapered to no less than 0.1 mg/kg at Month 3 for control and everolimus groups.
Intervention MeSH terms: Cyclosporine; Mycophenolic Acid; Everolimus; Cyclosporins
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 95.0
Sex: All
Healthy volunteers: No
Keywords: allograft rejection; xenograft rejection; host vs graft disease; transplant

Summary:

      The major aim of this extension study was to evaluate the long-term effect (i.e. 5 to 7
      years) of early initiation of everolimus and early elimination of CsA compared to standard
      immunosuppressive regimen including CsA on primary and secondary endpoints investigated in
      the SCHEDULE (NCT01266148) main study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who participated in the SCHEDULE 12-month main study, and who completed the 3
             year follow-up visit

          -  Patients who are coming for a regular annual clinic visit 5 to 7 years after
             randomization in the main study

          -  Obtaining of a separate signed patient informed consent will be required for
             participation in this follow-up examination.

        Exclusion Criteria:

          -  Patients with a retransplanted heart since the original SCHEDULE study
Evaluating QTc, PK, Safety of Gemtuzumab Ozogamicin (GO) in Patients With CD33+ R/R AML
Condition: ECG; Pharmacokinetics; Safety
Intervention: Gemtuzumab Ozogamicin
Intervention description: Three doses of GO 3 mg/m2 (up to one vial) as a 2 hour intravenous infusion on Cycle 1 Days 1, 4, and 7. A second cycle of GO 3mg/m² (up to one vial) on Cycle 2 Days 1, 4, and 7 will be allowed at the investigator's discretion for patients who meet the criteria
Intervention MeSH terms: Gemtuzumab
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Single arm, open-label, interventional
Masking: None (Open Label)
Masking description: open-label
Enrollment: 51.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: gemtuzumab ozogamicin; Mylotarg; QT interval prolongation; Pharmacokinetics; Safety; Veno-occlusive disease; Anti-drug antibody

Summary:

      This is a single-arm, open-label, Phase 4 study evaluating the effect of GO on the QTc,
      pharmacokinetics, safety, and immunogenicity of GO as a single-agent monotherapy in adult and
      pediatric patients with relapsed or refractory CD33-positive AML.
    

Eligibility criteria:

        Inclusion Criteria

          -  Refractory or relapsed (ie, bone marrow blasts >5%) CD33-positive AML.

          -  Age >=12 years.

          -  Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 2.

          -  Initial peripheral white blood cells (WBC) counts >=30,000/mL; patients with a higher
             WBC count should undergo cytoreduction.

          -  Adequate renal/hepatic functions

        Exclusion Criteria

          -  Patients with prior treatment with gemtuzumab ozogamicin (GO).

          -  Patients with prior history of VOD/SOS.

          -  Prior HSCT is not allowed, if it was conducted within 2 months prior to study
             enrollment.

          -  Patients with known active central nervous system (CNS) leukemia.

          -  Uncontrolled or active infectious status.

          -  Uncontrolled cardiac dysrhythmias of NCI CTCAE Grade 2, uncontrolled atrial
             fibrillation of any grade.

          -  Sero-positivity to human immunodeficieny virus (HIV).

          -  Active hepatitis B or hepatitis C infection

          -  Chemotherapy, radiotherapy, or other anti-cancer therapy (except hydroxyurea as
             cytoreduction) within 2 weeks prior to enrollment in the study.

          -  Major surgery within 4 weeks prior to enrollment.

          -  QTc interval >470 milliseconds (msec) using the Fridericia (QTcF), family or personal
             history of long or short QT syndrome, Brugada syndrome or known history of QTc
             prolongation, or Torsade de Pointes (TdP).

          -  The use of medications known to predispose to Torsades de Pointes within 2 weeks prior
             to enrollment

          -  History of allergic reactions attributed to compounds of similar chemical or biologic
             composition to gemtuzumab ozogamicin (GO).
Safety and Tolerability of Repatha® (Evolocumab) in Indian Participants With Homozygous Familial Hypercholesterolemia
Condition: Homozygous Familial Hypercholesterolemia HoFH
MeSH terms: Hyperlipoproteinemia Type II; Homozygous Familial Hypercholesterolemia; Hypercholesterolemia
Intervention: evolocumab
Intervention description: Administered by SC injection via autoinjector (AI)/pen
Intervention MeSH terms: Evolocumab
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 12 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Evolocumab; Hypercholesterolemia

Summary:

      To describe the safety and tolerability of evolocumab in participants with homozygous
      familial hypercholesterolemia (HoFH) in India. All participants will receive evolocumab over
      an 8-week period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female ≥ 12 to ≤ 80 years of age at the time of signing the informed consent

          -  Diagnosis of HoFH based on low-density lipoprotein cholesterol (LDL-C), familial
             history and xanthoma

          -  On a low-fat diet and receiving background lipid-lowering therapy stable for 4 weeks
             prior to screening and during the time frame of the trial

          -  Fasting LDL-C at screening > 130 mg/dL (3.4 mmol/L)

          -  Fasting triglycerides at screening ≤ 400 mg/dL (4.5 mmol/L)

        Exclusion Criteria:

          -  Use of mipomersen or lomitapide within 6 months of screening.

          -  Known active infection or major hematologic, renal, metabolic, gastrointestinal,
             hepatic, or endocrine dysfunction

          -  Currently receiving treatment in another investigational device or drug study, or less
             than 30 days since ending treatment on another investigational device or drug
             study(ies)

          -  Female subject is pregnant or breastfeeding or planning to become pregnant or
             breastfeed

          -  Female subjects of childbearing potential unwilling to use an acceptable method of
             effective contraception

          -  Subject has known sensitivity to any of the products to be administered during dosing

          -  History or evidence of any other clinically significant disorder, condition or disease

          -  Subject has previously received evolocumab or any other proprotein convertase
             subtilisin/kexin type 9 (PKSK-9)-inhibiting therapy
Hepatic Safety of Raltegravir Versus Efavirenz as HIV Therapy for Patients With HIV and HCV Coinfection
Condition: Hepatitis C, Chronic; HIV Infection
MeSH terms: Hepatitis C; Hepatitis C, Chronic; Hepatitis
Intervention: Raltegravir; Efavirenz
Intervention description: Emtricitabine/tenofovir DF* 200 mg/300 mg po daily + Raltegravir 400 mg twice daily; Emtricitabine/tenofovir DF* 200 mg/300 mg po daily + Efavirenz 600 mg po daily
Intervention MeSH terms: Efavirenz; Raltegravir Potassium
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 80.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HIV/HCV co-infection; Antiretroviral therapy

Summary:

      The main objective is to evaluate the hepatic safety of raltegravir when compared to
      efavirenz, both in combination with tenofovir and emtricitabine as first-line HIV treatment
      in patients with HIV and hepatitis C coinfection.
    

Eligibility criteria:

        Inclusion Criteria:

          -  HIV infected patients, age >18 years, meet Vietnam guideline to begin ART (CD4 count <
             350 cells/mm3 and/or WHO stage III or IV disease)

          -  Hepatitis C infection as documented by positive HCV antibodies and a detectable serum
             HCV RNA level

          -  AST and ALT ≤ 2 x ULN (≤ 80 U/L)

          -  Estimated creatinine clearance ≥ 60 mL/min

        Exclusion Criteria:

          -  Any prior ART

          -  Positive Hepatitis B surface antigen

          -  Clinical evidence of de-compensated cirrhosis (ascites, encephalopathy, esophageal
             bleeding)

          -  Requirement for acute therapy for other AIDS-defining illness within 14 days prior to
             study entry

          -  Currently on rifampicin therapy

          -  In the first trimester of pregnancy, intent to become pregnant, or breast feeding
             during the study period
Betadine Bladder Irrigations vs. Standard of Care Prior to Indwelling Catheter Removal
Condition: Catheter; Infection (Indwelling Catheter); Catheter Infection; Catheter-Related Infections; Catheter Bacteraemia; Urinary Tract Infections
MeSH terms: Infections; Communicable Diseases; Urinary Tract Infections; Bacteremia; Catheter-Related Infections
Intervention: Povidone-iodine irrigation
Intervention description: Single dose, 60 cc of 2% povidone-iodine indwelling for 10 minutes prior to catheter removal using aseptic technique
Intervention MeSH terms: Povidone-Iodine; Povidone
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 2 arm parallel study with 1 to 1 randomization
Masking: None (Open Label)
Enrollment: 3.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Catheter associated UTI; Povidine iodine; Bladder Irrigation

Summary:

      Over the last decade, there has been great emphasis on reducing the incidence of
      hospital-acquired infections, including catheter-associated UTI (CAUTI). This study will
      evaluate the effectiveness of Betadine irrigation solution (2% povidone-iodine) instilled
      into the bladder immediately prior to indwelling catheter removal to decrease the risk of
      subsequent bacteriuria, leading to decreased rates of NHSN defined CAUTI.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Provide written informed consent and the willingness and ability to comply with all
             aspects of study requirements

          2. Male

          3. Inpatients ≥ 18 years of age with an indwelling catheter in place for at least 5 days
             with a plan for removal

        Exclusion Criteria:

          1. Patients planned for discharge with an indwelling catheter in place

          2. Patients unable to report urinary symptoms accurately

          3. Patients with hyper-sensitivity or allergic reaction to Betadine, iodine, shellfish or
             other related compounds

          4. Clinical signs or symptoms of urinary tract infection at the time of consent

          5. Patients currently being treated for UTI

          6. Patients currently taking any antibiotic medication, other than vancomycin, linezolid,
             daptomycin, clindamycin, or metronidazole.

          7. Patients already taking medications known to potentially irritate the bladder, such
             as, but not limited to, cyclophosphamide, ifosfamide, and other chemotherapeutic
             agents

          8. Patients with history of bladder cancer, pelvic radiation or interstitial cystitis

          9. Patients unable to comply with study requirements

         10. Any other condition which, per investigators' judgment, may increase patient risk
             and/or impede the reliability of study data