bioihbjkbjnl/mcl2 huggingface dataset:
Short Course Vaginal Cuff Brachytherapy in Treating Patients With Stage I-II Endometrial Cancer
Condition: Endometrial Clear Cell Adenocarcinoma; Endometrial Endometrioid Adenocarcinoma; Endometrial Serous Adenocarcinoma; Stage I Uterine Corpus Cancer; Stage IA Uterine Corpus Cancer; Stage IB Uterine Corpus Cancer; Stage II Uterine Corpus Cancer; Uterine Corpus Carcinosarcoma; Uterine Corpus Sarcoma
MeSH terms: Adenocarcinoma; Endometrial Neoplasms; Cystadenocarcinoma, Serous; Carcinoma, Endometrioid; Carcinosarcoma; Adenocarcinoma, Clear Cell
Intervention: Vaginal Cuff Brachytherapy; Short course vaginal cuff brachytherapy
Intervention description: Undergo standard of care vaginal cuff brachytherapy; Undergo short course vaginal cuff brachytherapy
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 108.0
Sex: All
Healthy volunteers: No

Summary:

      This randomized phase III trial studies short course vaginal cuff brachytherapy to see how
      well it works compared with standard of care vaginal cuff brachytherapy in treating patients
      with stage I-II endometrial cancer. Short course vaginal cuff brachytherapy, also known as
      internal radiation therapy, uses (over a shorter period) radioactive material placed directly
      into or near a tumor in the upper portion of the vagina to kill tumor cells.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed endometrial carcinoma: endometrioid type, serous, and clear
             cell, to include tumors originating in the cervix, but are primarily located in the
             uterus, and for whom vaginal cuff brachytherapy is indicated. Carcinosarcoma and other
             sarcomas are permitted; Federation of Gynecology and Obstetrics (FIGO) stage I, with
             one of the following combinations of stage and grade:

               -  Stage IA, grade 2, 3

               -  Stage IB, grades 1-3

               -  Stage II, grades 1-3

          -  Patients post hysterectomy and free from residual disease

          -  World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG)-performance
             status 0-2

          -  Able to provide informed consent and willing to sign an approved consent form that
             conforms to federal and institutional guidelines

          -  Life expectancy of >2 years.

        Exclusion Criteria:

          -  Stages of endometrial carcinoma other than described

          -  Previous pelvic radiotherapy

          -  Interval between the hysterectomy and planned start of radiotherapy exceeding 16 weeks
A Study Assessing Saxagliptin Treatment in Type 2 Diabetic Subjects Who Are Not Controlled With TZD Therapy Alone
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Intervention: Saxagliptin; Saxagliptin; Placebo; pioglitazone; rosiglitazone; metformin
Intervention description: Tablets, Oral, 2.5 mg, Once daily (6 months ST, 12 months LT); Tablets, Oral, 5 mg, once daily (6 months ST, 12 months LT); Tablets, Oral, 0 mg, Once daily (6 months ST, 12 months LT); Tablets, Oral, 30 mg or 45 mg, once daily (6 months ST, 12 months LT); Tablets, Oral, 4 mg, once daily or 8 mg, either as once or twice daily (6 months ST, 12 months LT); Tablets, Oral, 500-2500 mg, as needed (12 months LT)
Intervention MeSH terms: Metformin; Pioglitazone; Rosiglitazone; Saxagliptin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 565.0
Sex: All
Minimum age: 18 Years
Maximum age: 77 Years
Healthy volunteers: No

Summary:

      The purpose of this clinical research study is to learn whether Saxagliptin added to
      thiazolidinedione (TZD) therapy is more effective than TZD alone as a treatment for Type 2
      diabetic subjects who are not sufficiently controlled with TZD alone
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 2 diabetics currently receiving a stable dose of TZD monotherapy (pioglitazone
             30mg or 45mg, or rosiglitazone 4mg or 8mg) for at least 12 weeks prior to screening.

          -  Hemoglobin A1c (HbA1c) > = 7.0% and < = 10.5%

          -  Body mass index < = 45kg/m2

          -  Fasting C-peptide > = 1 ng/mL

        Exclusion Criteria:

          -  Symptomatic poorly controlled diabetes

          -  Recent cardiac or cerebrovascular event

          -  Serum creatinine > = 2.0 mg/dL
Safety and Efficacy Evaluation of Topical AL-60371 Otic Suspension, 0.3% in the Treatment of Acute Otitis Externa
Condition: Acute Otitis Externa
MeSH terms: Otitis; Otitis Externa
Intervention: AL-60371, 0.3% Otic Suspension; AL-60371 Vehicle
Intervention description: Inactive ingredients used as a placebo comparator
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 768.0
Sex: All
Minimum age: 6 Months
Healthy volunteers: No
Keywords: Acute Otitis Externa

Summary:

      The purpose of this study was to demonstrate the superiority of AL-60371, 0.3% Otic
      Suspension relative to AL-60371 Vehicle based on clinical cures at test-of-cure (TOC) for the
      treatment of acute otitis externa (AOE).
    

Eligibility criteria:

        Inclusion Criteria:

          -  At least 6 months of age.

          -  Clinical diagnosis of acute otitis externa (AOE) based on clinical observation and of
             presumed bacterial origin in at least one ear.

          -  Combined numerical score of ≥4 in at least one affected ear at the Day 1 exam for
             tenderness, erythema, and edema.

          -  Agree to refrain from water immersion of the ears during the conduct of the entire
             study.

          -  Other protocol-defined inclusion criteria may apply.

        Exclusion Criteria:

          -  Duration of signs or symptoms of AOE greater than 28 days in the affected ear(s) as
             reported by patient or parent/guardian.

          -  Presence of a tympanostomy tube or perforated tympanic membrane in the affected
             ear(s).

          -  Clinically diagnosed otic disease other than AOE (eg, malignant otitis externa) in the
             affected ear(s).

          -  Known or suspected ear infection of yeast, fungal or mycobacterial origin in the
             affected ear(s).

          -  Prior otologic surgery within 6 months of study entry in the affected ear(s).

          -  Known or suspected allergy or hypersensitivity to quinolones or other ingredients
             present in the medications to be used in the study.

          -  Patients who use ear plugs, head phones or ear buds and are unwilling to discontinue
             their use during the study period.

          -  Other protocol-defined exclusion criteria may apply.
Labor and Delivery Implant Insertion: A Randomized Controlled Trial
Condition: Postpartum Contraception; Family Planning
Intervention: Etonogestrel-Immediate; Etonogestrel-Delayed
Intervention description: The investigational intervention will be to insert the contraceptive implant immediately postpartum in the delivery room insertion (0-2 hours following delivery).; The investigational intervention will be to insert the contraceptive implant 24-48 hours following delivery.
Intervention MeSH terms: Contraceptive Agents; Etonogestrel; Desogestrel
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 95.0
Sex: Female
Healthy volunteers: Accepts Healthy Volunteers
Keywords: contraceptive implant; postpartum contraception; breastfeeding and contraception

Summary:

      A barrier to initiating progestin contraceptives in the early postpartum period is the
      concern of interference with breastfeeding, specifically lactogenesis. In this trial, the
      investigators aim to describe the effects of immediate insertion of the contraceptive implant
      on breastfeeding. The investigators seek to examine the time to lactogenesis with immediate
      post-delivery insertion in delivery room versus insertion of a contraceptive implant in the
      postpartum ward prior to medical discharge. For this study, 82 consenting women will be
      randomized to immediate implant insertion (0-2 hours following delivery) in the delivery room
      or insertion of the implant following delivery in postpartum room and prior to medical
      discharge (24-48 hours following delivery).

      Participants complete a questionnaire that asks questions about breastfeeding continuation,
      supplementation, duration, and exclusivity. This questionnaire also includes questions about
      contraceptive continuation, patient satisfaction with implant, pregnancy, and postpartum care
      visits.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pregnant women who are patients of the Stanford University Obstetrics service

          -  Pregnant women who delivery a healthy infant, regardless of gestational age.

          -  Intend to breastfeed

          -  Desire the contraceptive implant as their method of contraception

          -  Agree to be randomized to delivery room vs. postpartum ward insertion

        Exclusion Criteria:

          -  Not English or Spanish speaking

          -  Allergy or Contraindication to contraceptive implant.
Clinical Investigation Using MED3000 Gel or Tadalafil Tablets in the Treatment of Erectile Dysfunction
Condition: Erectile Dysfunction
MeSH terms: Erectile Dysfunction
Intervention: MED3000 (Male); Tadalafil 5mg (Male); MED3000 (Female); Tadalafil 5mg (Female)
Intervention description: Gel formulation; Tablets; Gel formulation; Tablets
Intervention MeSH terms: Tadalafil
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients will be randomised to receive either MED3000 gel or tadalafil (5 mg) tablets after a 4 -6 week screening period
Masking: None (Open Label)
Enrollment: 116.0
Sex: Male
Minimum age: 22 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      An open-label investigation using MED3000 gel or tadalafil (5 mg) tablets in the treatment of
      erectile dysfunction in patients from 22 to 70 years of age. Each patients will be expected
      to participate for up to 30 weeks. Eligible patients will be randomised to receive either
      MED3000 gel or tadalafil (5 mg) tablets in a 1:1 ratio.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male heterosexual patients aged 22-70 years.

          -  Confirmed clinical diagnosis of mild, moderate or severe ED for more than 3 months.

          -  Involved in a continuous heterosexual relationship with their partner for at least 6
             months.

        Exclusion Criteria:

          -  Any significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal,
             haematological, endocrinological, metabolic, neurological or psychiatric disease.

          -  History of unstable medical or psychiatric condition or using any medication that, in
             the opinion of the Principal Investigator, is likely to affect the patient's ability
             to complete the investigation or precludes the patient's participation in the
             investigation.
A Study to Assess Efficacy and Safety of Two Different Dose Regimens of Risankizumab Administered Subcutaneously in Japanese Subjects With Generalized Pustular Psoriasis or Erythrodermic Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: risankizumab
Intervention description: risankizumab administered by subcutaneous injection
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Generalized Pustular Psoriasis; Erythrodermic Psoriasis; risankizumab; Japanese

Summary:

      The purpose of this study is to investigate the safety and efficacy of two different dose
      regimens of risankizumab for Japanese subjects with generalized pustular psoriasis (GPP) or
      erythrodermic psoriasis (EP).
    

Eligibility criteria:

        Inclusion Criteria:

        For GPP

          -  Have a diagnosis of GPP for at least 60 days prior to informed consent based on the
             diagnostic criteria of the Japanese Dermatological Association (JDA). Subjects not
             fulfilling one of the diagnostic criteria i.e., "accompanying systemic symptoms
             including fever or malaise" at the time of screening can be entered.

          -  Subjects with an erythema area with pustules accounting for ≥ 10% of the body surface
             area (BSA), and with a severity assessment criteria score (JDA total score) specified
             by the JDA of less than 14.

          -  Must be candidates for systemic therapy or phototherapy for GPP, as assessed by the
             investigator.

        For EP

          -  Have a diagnosis of EP prior to informed consent.

          -  Subjects with an inflammatory erythema area accounting for ≥ 80% of the BSA at
             screening and at the time of the first administration of the study drug.

          -  Must be candidates for systemic therapy or phototherapy for EP, as assessed by the
             investigator.

        Exclusion Criteria:

          -  Previous exposure to risankizumab.

          -  Currently enrolled in another investigational study or less than 30 days (from
             screening) since completing another investigational study (participation in
             observational studies is permitted).

        For GPP

          -  Subjects with active ongoing inflammatory diseases other than GPP that might confound
             trial evaluations according to investigator's judgment.

        For EP

          -  Subjects with active ongoing inflammatory diseases other than EP that might confound
             trial evaluations according to investigator's judgment.

          -  Subject diagnosed with medication-induced or medication-exacerbated EP.
Besifloxacin Ophthalmic Suspension Verses Gatifloxacin Ophthalmic Solution in Neonates With Bacterial Conjunctivitis
Condition: Bacterial Conjunctivitis
MeSH terms: Conjunctivitis, Bacterial; Conjunctivitis
Intervention: Besivance; Gatifloxacin
Intervention description: Besifloxacin hydrochloride 0.6% ophthalmic suspension, one drop instilled into infected eye, three times daily (TID) for 7 days; Gatifloxacin 0.3% ophthalmic solution one drop instilled into infected eye, TID for 7 days
Intervention MeSH terms: Gatifloxacin; Besifloxacin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Enrollment: 33.0
Sex: All
Minimum age: 1 Day
Maximum age: 31 Days
Healthy volunteers: No
Keywords: Ocular infections, bacterial

Summary:

      The objective of this study is to evaluate the safety and efficacy of Besivance (besifloxacin
      0.6%) ophthalmic suspension compared to gatifloxacin 0.3% ophthalmic solution when
      administered three times daily (TID) for seven days to neonatal subjects who are 31 days or
      younger on the day of randomization (Visit 1).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who have a clinical diagnosis of acute bacterial conjunctivitis and exhibit
             conjunctival discharge and redness in at least one eye. A minimum score of 1 should be
             present for discharge and a minimum score of 1 for conjunctival hyperemia in the same
             eye.

        Exclusion Criteria:

          -  Subjects with conjunctivitis signs and/or symptoms suggestive of fungal, protozoal, or
             viral etiology in either eye.

          -  Subjects who require or are expected to require (other than study medication) use of
             any topical ocular medication in either eye, or systemic medications during the course
             of the study or prior to Day 1 specified in the protocol as ineligible.

          -  Subjects with any abnormality of the ocular anatomy or ocular disease/disorder
             specified in the protocol as ineligible.

          -  Subjects with systemic disease/disorder specified in the protocol as ineligible.

          -  Subjects who have a known or suspected poor tolerance, sensitivity, or allergy to the
             study medications or any of their components.

          -  Subjects who have a condition or are in a situation which in the investigator's
             opinion may impact their safety or would negatively affect the conduct or outcome of
             the study.
Pilot Study of the Effect of Hyperbaric Oxygen Treatment on Behavioral and Biomarker Measures in Children With Autism
Condition: Autism
MeSH terms: Autistic Disorder
Intervention: Hyperbaric Oxygen Treatment (HBOT)
Intervention description: 1.5 ATA at 100% Oxygen of HBOT
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 3 Years
Maximum age: 8 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to increase the understanding of the effect of Hyperbaric Oxygen
      Treatment (HBOT) on the behavior and functioning of children with autism. The main goal of
      this study is to demonstrate that HBOT is safe and tolerable in autistic children, and to
      measure the effect of HBOT on specific chemicals in their blood that may play a role in the
      child's behavior.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Diagnosis of DSM-IV defined autism and meets cut off for autism on the Autism
             Diagnostic Inventory-Revised (ADI-R) or Social Communication Questionnaire (SCQ) and
             the Autism Diagnostic Observation Scale (ADOS).

          2. Age 3 to 8 years.

          3. Nonverbal IQ of 50 or above.

          4. Parental agreement to continue present dietary, behavioral or psychotropic drug
             treatment but not change treatment during 20 week intervention.

        Exclusion Criteria:

          1. Clinical evidence of seizure disorder

          2. Active infection with fever

          3. Fragile X or other known genetic cause of autism

          4. Perinatal brain injury (e.g. cerebral palsy)

          5. Previous adequate trial (at least 20 session) of HBOT

          6. Inability to clear ears in the HBOT chambers
Phase III Study of BMS-188667 (CTLA4Ig) in Patients With Rheumatoid Arthritis Who Are Currently Failing Anti-TNF Therapy or Who Have Failed Anti-TNF Therapy in the Past.
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Abatacept; Placebo; Abatacept
Intervention description: Vials, intravenous (IV), ~10mg/kg abatacept, One every 2 weeks for first month then every 4 weeks thereafter, 6 months.; Vials, IV, 0mg, One every 2 weeks for first month then every 4 weeks thereafter, 6 months.; Vials, IV, ~10mg/kg abatacept, every 4 weeks, 5.5 years
Intervention MeSH terms: Abatacept
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 738.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this clinical research study is to determine whether abatacept treatment on a
      background of Disease Modifying Antirheumatic Drugs (DMARDs) will relieve the symptoms of
      rheumatoid arthritis (RA) in participants who are currently receiving anti-tumor necrosis
      factor (TNF) therapy for at least 3 months and are not responding or have taken anti-TNF
      therapy in the last 3 months and did not respond. The safety of treatment with abatacept will
      also be evaluated. This study also has a 4.5-year long-term extension beginning 6 months
      after the start of the study.
    

Eligibility criteria:

        Eligibility Criteria:

          -  Active rheumatoid arthritis currently failing anti-TNF therapy or have failed anti-TNF
             therapy in the past.

        Exclusion Criteria:

          -  Women who are pregnant or breast feeding

          -  Current symptoms of serious medical disease

          -  History of cancer in last 5 years other than non-melanoma skin cancer

          -  Chronic serious infection

          -  Active TB requiring treatment in last 5 years

          -  Herpes zoster in last 2 months

          -  Any active viral infection including Human Immunodeficiency Virus (HIV)

          -  Serious side effects associated with previous anti-TNF therapy
Study Evaluating A Novel Ibuprofen Formulation In The Treatment Of Dental Pain
Condition: Pain
MeSH terms: Toothache
Intervention: Novel Ibuprofen; Standard Ibuprofen; Standard Ibuprofen; Placebo
Intervention description: Single-dose of novel ibuprofen (equal to 400 mg ibuprofen); Single-dose of standard ibuprofen (400mg); Single-dose of standard ibuprofen (400mg); Single-dose of placebo
Intervention MeSH terms: Ibuprofen
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 335.0
Sex: All
Minimum age: 16 Years
Maximum age: 40 Years
Healthy volunteers: No
Keywords: Pain following third molar extraction

Summary:

      This study will compare the pain relieving effect of a single-dose of a novel ibuprofen
      formulation to placebo and two formulations of standard ibuprofen in the treatment of
      post-surgical dental pain following "wisdom" tooth (third molar) removal.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Normal, healthy males and females 16 to 40 years of age

          -  Outpatients who have moderate to severe post-operative pain (confirmed by a Visual
             Analog Scale-Pain Severity Rating [VAS-PSR] score of at least 50 mm on a 100 mm
             VAS-PSR) following surgical extraction of two or more third molars, at least one of
             which must be a partial or complete bony mandibular impaction

          -  Use of only the following pre-operative medication(s)/anesthetic(s): topical
             benzocaine, a short acting parenteral (local) anesthetic (mepivacaine or lidocaine)
             with or without vasoconstrictor and/or nitrous oxide

        Exclusion Criteria:

          -  Pregnancy or breast-feeding

          -  Alcohol or substance abuse

          -  Any serious medical or psychiatric disorder

          -  History of stomach ulcers, stomach bleed, or other bleeding disorders

          -  Use of a prescription or over-the-counter drug with which administration of ibuprofen
             or any other non-steroidal anti-inflammatory drug, acetaminophen, or hydrocodone is
             contraindicated (including: opioids, antipsychotics, antianxiety agents, or other
             central nervous system depressants[including alcohol])