bioihbjkbjnl/mcl2 huggingface dataset:
Heparin Prophylaxis Dosing for Antepartum Hospitalizations (HEPDOSE)
Condition: Pregnancy Related; Antepartum DVT
Intervention: Standard Dose of Unfractionated Heparin; Gestational Age-Based Dose of Unfractionated Heparin
Intervention description: 5,000 units subcutaneous unfractionated heparin every 12 hours; First trimester (< 14 weeks of gestation): 5,000 units subcutaneous unfractionated heparin every 12 hours
Second trimester (14-28 weeks of gestation): 7,500 units subcutaneous unfractionated heparin every 12 hours
Third trimester (> 28 weeks of gestation): 10,000 units subcutaneous unfractionated heparin every 12 hours
Intervention MeSH terms: Heparin; Calcium heparin
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 46.0
Sex: Female
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Thromboprophylaxis; Antepartum admission; Heparin

Summary:

      This study is a randomized control trial to compare gestational age-based dosing with
      standard dosing of unfractionated heparin for thromboprophylaxis of hospitalized antepartum
      patients. The investigators aim to determine the effect of dosing on receipt of neuraxial
      anesthesia and pregnancy outcomes and evaluate the pharmacokinetics and pharmacodynamics of
      unfractionated heparin in pregnancy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  At least 18 years of age

          -  Speak English or Spanish

          -  Antepartum admission for at least 72 hours at Ronald Reagan UCLA Medical Center

          -  Provides informed consent for study participation

        Exclusion Criteria:

          -  Active or threatened antenatal bleeding

          -  Disseminated intravascular coagulation

          -  Risk of imminent delivery (delivery within 12 hours)

          -  Thrombocytopenia (platelet count < 100 x 109)

          -  Elevated baseline aPTT (> 36.2 seconds)

          -  Concern for hemolysis, elevated liver enzymes, low platelet count (HELLP) syndrome

          -  Congenital bleeding disorders (hemophilias)

          -  Receiving therapeutic or prophylactic anticoagulation (unfractionated heparin, low
             molecular weight heparin, oral anticoagulants) for alternative indication (e.g.,
             acquired or inherited thrombophilia, history of VTE)

          -  History of heparin-induced thrombocytopenia (HIT)

          -  SARS-CoV-2 positive

          -  Cognitive impairment, psychiatric instability, or language barriers that limit their
             ability to provide informed consent

          -  Presence of a condition or abnormality that in the opinion of the Investigator would
             compromise the safety of the patient or the quality of the data.
Strattice in Repair of Inguinal Hernias
Condition: Hernia, Inguinal
MeSH terms: Hernia; Hernia, Inguinal
Intervention: Inguinal hernia repair with Ultrapro; Inguinal hernia repair with Strattice
Intervention description: surgical mesh (15x15cm) to support Lichtenstein repair; Surgical mesh (10x16) used to support Lichtenstein repair
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 172.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: surgical mesh; inguinal hernia repair; chronic groin pain

Summary:

      This is a prospective, randomized, controlled, third-party blinded, multicenter,
      interventional evaluation of inguinal hernia repair comparing Strattice to light weight
      polypropylene mesh. Performance and outcomes measures to be compared include postoperative
      resumption of activities of daily living, nature and incidence of short- and long-term pain
      and complications, and incidence of hernia recurrence.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult male

          -  symptomatic and palpable inguinal hernia

          -  open, elective, primary unilateral inguinal hernia repair

        Exclusion Criteria:

          -  bilateral inguinal hernia repair

          -  BMI >35

          -  chronic immunosuppression, active chemo/radiation therapy, uncontrolled diabetes,
             severe liver disease or COPD

          -  chronic prostatitis, orchitis, testicular pain

          -  local or systemic infection at time of repair

          -  known collagen disorder

          -  chronic pain syndrome or under active pain management
Study Comparing Tigecycline Versus Ceftriaxone Sodium Plus Metronidazole in Complicated Intra-abdominal Infection (cIAI)
Condition: Appendicitis; Cholecystitis; Diverticulitis; Intra-Abdominal Abscess; Intra-Abdominal Infection; Peritonitis
MeSH terms: Infections; Communicable Diseases; Appendicitis; Abscess; Peritonitis; Intraabdominal Infections; Abdominal Abscess; Cholecystitis; Diverticulitis
Intervention: tigecycline; ceftriaxone plus metronidazole
Intervention description: every 12 hours IV (an initial dose of 100 mg followed by 50 mg every 12 hours); Ceftriaxone sodium 2 g once daily intravenously plus metronidazole 1 g to 2 g daily given in divided doses intravenously. Test article should be administered for a minimum of 4 days and up to 14 days at the discretion of the investigator.
Intervention MeSH terms: Metronidazole; Ceftriaxone; Tigecycline
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 473.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Intra-Abdominal Infections; Abscess

Summary:

      This is a study of the safety and efficacy of tigecycline to ceftriaxone sodium plus
      metronidazole in hospitalized subjects with cIAI. Subjects will be followed for efficacy
      through the test-of-cure assessment. Safety evaluations will occur through the treatment and
      post-treatment periods and continue through resolution or stability of the adverse event(s).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of complicated intra-abdominal infection that requires surgery
             within 24 hours.

          -  Fever plus other symptoms such as nausea, vomiting, abdominal pain.

        Exclusion Criteria:

          -  Cancer

          -  Medicines that suppress the immune system

          -  Dialysis
Omega Tots: A Randomized, Controlled Trial of Long-chain Polyunsaturated Fatty Acid Supplementation of Toddler Diets and Developmental Outcomes
Condition: Preterm Birth; Child Development
MeSH terms: Premature Birth
Intervention: Docosahexaenoic Acid + Arachidonic Acid (DHA+AA); Placebo
Intervention description: 200 mg DHA+ 200 mg AA per day for 6 months; 400 mg corn oil per day for 6 months
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 377.0
Sex: All
Minimum age: 10 Months
Maximum age: 16 Months
Healthy volunteers: No

Summary:

      The purpose of this study is to examine whether supplementation with certain polyunsaturated
      fatty acids can help the cognitive development of children born preterm.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age 10-16 completed months (age corrected for prematurity) at baseline

          2. Discontinued regular breastfeeding and formula feeding at the time of randomization

          3. Gestational age < 35 completed weeks at birth

          4. English is primary language in home

          5. Informed consent obtained and signed

          6. Child admitted to any NCH managed NICU or children who have ever had a Neonatology
             Clinic follow up visit scheduled, regardless of attendance

        Exclusion Criteria:

          1. Feeding problems

          2. Major malformation, metabolic, or digestive disorder that would preclude participation
             and/or optimal absorption of the supplement.

          3. Weight < 5th or > 95th percentile for age, per WHO growth charts

          4. Consume DHA supplement drops, chews, or powders or Pediasure, or fatty fish more than
             2x per week

          5. Plans to move out of the area within the next 6 months

          6. Known corn allergy

          7. Known soy allergy

          8. Known fish allergy
Study of Brentuximab Vedotin in Participants With Relapsed or Refractory Systemic Anaplastic Large Cell Lymphoma
Condition: Lymphoma
MeSH terms: Lymphoma; Lymphoma, Large-Cell, Anaplastic
Intervention: Brentuximab vedotin
Intervention description: Brentuximab vedotin IV infusion
Intervention MeSH terms: Brentuximab Vedotin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Lymphoma; Anaplastic Large-cell; Relapsed; Refractory; Antigens, CD30; Antibody-Drug Conjugate; Antibodies, Monoclonal; Lymphoma, Non-Hodgkin; Lymphoma, Large-Cell, Anaplastic; monomethyl auristatin E; Drug Therapy; Immunotherapy; Hematologic Diseases

Summary:

      The purpose of this study is to assess the antitumor efficacy of single-agent brentuximab
      vedotin 1.8 mg/kg administered intravenously (IV) every 3 weeks, as measured by the overall
      objective response rate (ORR) in patients with r/r sALCL following at least 1 multiagent
      chemotherapy regimen (cyclophosphamide, doxorubicin hydrochloride [hydroxydaunorubicin],
      vincristine sulfate [Oncovin], and prednisone [CHOP] or equivalent multiagent chemotherapy
      regimens with curative intent).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female participants age 18 years or older, with relapsed or refractory sALCL
             who have previously received at least 1 multiagent chemotherapy

          -  Bidimensional measurable disease

          -  An Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

          -  Female participants who are postmenopausal for at least 1 year before the screening
             visit, surgically sterile, or agree to practice 2 effective methods of contraception,
             at the same time, from the time of signing the informed consent form through 30 days
             after the last dose of study drug, or agree to practice true abstinence

          -  Male participants who agree to practice effective barrier contraception during the
             entire study treatment period through 6 months after the last dose of study drug or
             agree to practice true abstinence

          -  Clinical laboratory values as specified in the study protocol

        Exclusion Criteria:

          -  Previous treatment with brentuximab vedotin.

          -  Previously received an allogeneic transplant.

          -  Participants with current diagnosis of primary cutaneous anaplastic large cell
             lymphoma [ALCL] (participants whose ALCL has transformed to sALCL are eligible).

          -  Known cerebral/meningeal disease including signs or symptoms of progressive multifocal
             leukoencephalopathy (PML)

          -  Female participants who are lactating and breastfeeding or pregnant

          -  Known human immunodeficiency virus (HIV) positive

          -  Known hepatitis B surface antigen-positive, or known or suspected active hepatitis C
             infection
GORE PROPATEN Vascular Graft vs. Disadvantaged Autologous Vein Graft
Condition: Peripheral Arterial Occlusive Disease
MeSH terms: Arterial Occlusive Diseases
Intervention: GORE PROPATEN Vascular Graft; Disadvantaged Autologous Vein Graft
Intervention description: Arterial Occlusion Bypass; Arterial Occlusion Bypass
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 31.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No

Summary:

      The primary patency of the GORE PROPATEN Vascular Graft is equivalent to or better than
      disadvantaged autologous vein graft in an infragenicular peripheral bypass application at 12
      months.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patient requires below-knee bypass secondary to severe claudication, rest pain or
             tissue loss due to peripheral arterial occlusive disease.

          2. Patient meets the disadvantaged autologous vein criteria described in Section 4.1.

          3. Patient has a post-operative life expectancy greater than one year.

          4. Patient is at least 21 years of age.

          5. Patient is able to comply with all study requirements and be available for follow-up
             visits at 1, 6, 12, 24 and 36-months post-procedure.

          6. Patient is willing and able to provide written, informed consent.

        Exclusion Criteria:

          1. Patient has had a previous instance of Heparin Induced Thrombocytopenia type 2 (HIT-2)
             or has known hypersensitivity to heparin.

          2. Patient requires an infragenicular bypass for reasons other than peripheral arterial
             occlusive disease.

          3. Patient requires sequential extremity revascularizations or other procedures that
             require use of additional vascular grafts.

          4. Patient is in need of, or is scheduled for, a cardiac surgical procedure or a
             different vascular surgical procedure within 30 days of study procedure. However,
             inflow procedures that facilitate the bypass are permitted, as long as they are not
             performed at the same sitting as the bypass procedure.

          5. Patient has been previously randomized for this study.

          6. Patient has active infection in the region of graft placement.
Cranial Electro Therapy Stimulation in Reducing Perioperative Anxiety
Condition: Anxiety
MeSH terms: Anxiety Disorders
Intervention: CRANIAL ELECTROTHERAPY (Alpha Stim) + SHAM MIDAZOLAM; MIDAZOLAM + SHAM ELECTRODES SIMULATING CRANIAL ELECTROTHERAPY; NO SEDATION WITH SHAM CRANIAL ELECTROSTIMULATION AND PLACEBO VERSED
Intervention description: APPLYING OF ELECTRODES ON THE EAR LOBES AND TEMPLES WHICH ARE SENDING AN ACTIVE MICROCURRENT THROUGH THE MIDBRAIN PRODUCING SEDATION WITHOUT PHARMACOLOGICAL AGENTS AND GIVING NORMAL SALINE AS A SHAM DRUG SEDATION; CONVENTIONAL METHOD OF PERIOPERATIVE SEDATION; NO ACTIVE SEDATION, ONLY SHAM ELECTRODES AND NORMAL SALINE SIMULATING MIDAZOLAM.
Intervention MeSH terms: Midazolam
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 115.0
Sex: All
Minimum age: 50 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: Cranial Electro Stimulation; First Eye Cataract Surgery; Preoperative sedation; Perioperative sedation

Summary:

      Cranial electro stimulation (CES) provides safe, adequate, side-effect free sedation without
      excessive drowsiness in preoperative settings.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients of both genders between 50 and 90 years old scheduled for an outpatient
             "first eye" cataract phacoemulsification with topical anesthesia.

          -  ASA classification I II and III

        Exclusion Criteria:

          -  ASA classification IV (patients with a chronic or severe disease).

          -  Hypersensitivity to midazolam or benzodiazepines

          -  acute narrow-angle glaucoma

          -  untreated open-angle glaucoma

          -  Patients with any sort of psychiatric or neurological disorder

          -  Patients on anti-anxiety medication

          -  Patients who have demand-type pacemakers installed before 1999* *Note: These are the
             exclusions listed for liability purposes by Alpha-Stim. There are no FDA exclusions.
Assessment of Subjects' Efficacy and Experiences Using Adapalene BPO Gel in the Treatment of Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: Adapalene 0.1% and Benzoyl Peroxide 2.5% gel
Intervention description: Apply adapalene BPO gel once daily in the evening for 12 weeks
Intervention MeSH terms: Adapalene; Benzoyl Peroxide
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: 16 Years
Maximum age: 25 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess subjects' experiences using Adapalene BPO gel to treat
      mild to moderate acne vulgaris using efficacy measurements, quality of life instruments, and
      video diaries.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subjects, aged 16 to 25 years inclusive;

          -  Subjects with mild or moderate facial acne (Investigator's Global Assessment (IGA) = 2
             or 3;

          -  A minimum of 10 inflammatory lesions (papules and pustules) on the face (excluding the
             nose);

          -  Subjects who agree to be photographed at each visit;

          -  Subjects who agree to be video recorded by study designated staff members. They should
             be able to clearly and comfortably communicate their responses to questions and
             express their thoughts related to their disease and treatment throughout the study

        Exclusion Criteria:

          -  Subjects with nodules, cysts, acne conglobata, acne fulminans, secondary acne
             (chloracne, drug-induced acne, etc.) or severe acne requiring systemic treatment;

          -  Subjects with a wash-out period for topical acne treatment on the face less than 30
             days

          -  Subjects with a wash-out period for systemic acne treatment less than 30 days with the
             exception of isotretinoin which requires a washout of 4 months;

          -  Subjects who are currently being treated with antibiotics;

          -  Subjects who foresee intensive ultraviolet (UV) exposure during the study (mountain
             sports, UV radiation, sunbathing, tanning beds, etc.);

          -  Subjects who refuse photographic and videography procedures and/or refuse to sign a
             full release for their use in promotional materials
A Study of Subject Satisfaction With BOTOX® Cosmetic Treatment in Facial Rhytides
Condition: Facial Rhytides
MeSH terms: Facies
Intervention: onabotulinumtoxinA; Normal Saline
Intervention description: BOTOX® (onabotulinumtoxinA) injected into the areas of glabellar lines and crow's feet lines on Day 1.; Placebo (normal saline) injected into the areas of glabellar lines and crow's feet lines on Day 1.
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 125.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This is a safety and efficacy study of BOTOX® in subjects with facial rhytides (glabellar
      lines and crow's feet lines).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Glabellar lines and crow's feet lines

          -  No prior use of botulinum toxin therapy of any serotype for any reason

        Exclusion Criteria:

          -  Previous facial cosmetic surgery, tissue grafting, or tissue augmentation with
             silicone or fat or other permanent fillers

          -  Planning a facial cosmetic procedure during the study period

          -  Diagnosis of myasthenia gravis, Eaton-Lambert Syndrome, and/or amyotrophic lateral
             sclerosis

          -  Anticipated need for treatment with botulinum toxin of any serotype for any reason
             during the study (other than study treatment)
Smoking Cessation Treatment for Methadone Maintenance Patients
Condition: Smoking Cessation; Substance-Related Disorders
MeSH terms: Substance-Related Disorders
Intervention: Varenicline; Placebo
Intervention description: Days 1-3: 0.5 mg once a day Days 4-7: 0.5 mg twice a day Days 8-84: 1 mg twice a day; Days 1-3: 1 pill daily Days 4-7: 2 pills daily Days 8-84: 2 pills daily
Intervention MeSH terms: Varenicline
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 112.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: methadone maintenance

Summary:

      Patients in substance abuse treatment smoke four times more than non-substance abusers, and
      suffer high rates of tobacco-related disease and death. While many quit smoking treatments
      exist that have been shown to help non-substance abusers quit smoking, little is known about
      what treatments work for patients in substance abuse treatment. The drug varenicline
      (Chantix) has been shown to be more effective at helping people quit smoking than nicotine
      replacement therapy, bupropion or placebo. However, varenicline has not yet been studied in
      patients in substance abuse treatment. The study aims to evaluate the feasibility,
      effectiveness and safety of varenicline, in combination with counseling, in methadone
      maintained smokers. It also aims to evaluate the link between quitting smoking and alcohol
      and illicit drug use in methadone maintained smokers. We hypothesize that participants
      receiving varenicline will have higher abstinence from smoking than participants receiving
      placebo and that participants taking varenicline will not have significantly more adverse
      reactions than were described in the general population in other studies. We also hypothesize
      that compared to continued smokers, tobacco abstainers will be more likely to be abstinent
      from alcohol or illicit drugs.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18 or older

          -  English speaking

          -  Smoked at least 100 cigarettes/lifetime

          -  Smokes 5 or more cigarettes per day

          -  Interested in quitting smoking (preparation or contemplation state of change)

          -  Enrolled in Einstein/Montefiore methadone program for 3 or more months

          -  Stable methadone dose for 2 weeks

          -  Agree to use contraception throughout the trial (among women with reproductive
             potential)

          -  Willing to participate in all study components

          -  Able to provide informed consent

        Exclusion Criteria:

          -  Serious or unstable HIV/AIDS, liver, cardiovascular, or pulmonary disease

          -  Psychiatric instability

          -  Women who are pregnant, breastfeeding, or contemplating pregnancy

          -  Creatinine clearance less than 30 mL/min