bioihbjkbjnl/mcl2 huggingface dataset:
Investigation of V520 in a HIV Vaccine Dose Refinement Study (V520-027)(TERMINATED)
Condition: HIV Infections
MeSH terms: HIV Infections
Intervention: MRKAd5 HIV-1 gag/pol/nef 4 x 10^9 Ad5 vg/dose (V520); MRKAd5 HIV-1 gag/pol/nef 8 x 10^9 Ad5 vg/dose (V520); MRKAd5 HIV-1 gag/pol/nef 1.5 x 10^10 Ad5 vg/dose (V520)
Intervention description: 3-dose regimen of 1.0-mL intramuscular injections of MRKAd5 HIV-1 gag/pol/nef 4 x 10^9 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26.; 3-dose regimen of 1.0-mL intramuscular injections of MRKAd5 HIV-1 gag/pol/nef 8 x 10^9 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26.; 3-dose regimen of 1.0-mL intramuscular injections of MRKAd5 HIV-1 gag/pol/nef 1.5 x 10^10 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26.
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 210.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: AIDS

Summary:

      This study will test the safety and immunogenicity of an investigational Human
      Immunodeficiency Virus (HIV) vaccine. Immunogenicity will be measured by evaluating the
      immune response to several different dose levels.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Demonstrates good general health

          -  Human Immunodeficiency Virus (HIV), Hepatitis B surface Antigen (HBsAg), and Hepatitis
             C (HCV) seronegative

          -  Low risk of acquiring HIV infection

          -  ALT lab value within normal range

        Exclusion Criteria:

          -  Previously received an investigational HIV vaccine

          -  Has a known or suspected impairment of immunologic function

          -  Has a clinically significant chronic medical condition that is considered progressive

          -  Has a major psychiatric illness

          -  Has any history of malignancy, with the exception of basal cell or squamous cell skin
             cancer

          -  Weighs less than 105 lbs.

          -  Has a recent (within two years) history of chronic alcohol abuse

          -  Has a contraindication to intramuscular (IM) injection, such as anticoagulant therapy
             or thrombocytopenia

          -  Female is pregnant or breast feeding, or expecting to conceive or donate eggs during
             the study

          -  Male subject is planning to impregnate or provide sperm donation during the study
Botanical Oil Supplementation in Diabetic and Metabolic Syndrome Subjects
Condition: Diabetes; Metabolic Syndrome x
MeSH terms: Metabolic Syndrome; Syndrome
Intervention: borage/echium oil combination; fish oil; corn oil
Intervention description: borage/echium oil combination containing 0.85g/day SDA and 1.7g/day GLA; 1.6g/day EPA and 1.08g/day DHA; contains 4.5 g/day linoleic acid
Intervention MeSH terms: Borage oil
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 80.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No
Keywords: diabetes; metabolic syndrome; inflammation; botanical oils

Summary:

      This study will compare how well a combination of borage and echium oils will reduce
      inflammation compared to fish oils and placebo oil in subjects that are diabetic or have
      metabolic syndrome.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adults, aged 21 years or more with either diabetes or metabolic syndrome. metabolic
             syndrome defined by NCEP/ATPIII criteria; must have 3 out of 5 of the following risk
             factors: 1.central obesity, men-greater than or equal to 40 inches, women-greater than
             or equal to 35 inches; 2.fasting blood TG greater than or equal to 150mg/dl or be
             taking TG lowering medications; 3. blood HDL cholesterol, men less than 40 mg/dl,
             women less than 50 mg/dl; 4. blood pressure greater than or equal to 130/85 or on HTN
             medication 5. fasting glucose greater than or equal to 100 mg/dl.

          -  participants on statins or glucose lowering drugs if dosages are stable for 3 months

        Exclusion criteria

          -  children/young adults less than 21 years of age

          -  currently using anti-inflammatory drugs including NSAIDS, oral/IV steroids or
             injection antiinflammatory drugs(for RA), aspirin greater than 100mg/day

          -  taking leukotriene receptor antagonists ( montelukast), tylenol or nasal/inhaled
             steroids OK.

          -  currently using niacin, fibrates or fish oil

          -  blood pressure greater than 170/100

          -  HB1Ac greater than 10%

          -  TG greater than 500 mg/dl

          -  myocardial infarction/vascular surgery/stroke within the past year

          -  any stage II,III,IV heart failure

          -  prior cholecystectomy

          -  end stage renal disease

          -  BMI less than 23 or greater than 45

          -  pregnancy

          -  alcohol use greater than 14 drinks per week

          -  current self reported tobacco or illicit drug use

          -  intolerance or allergy to fish oil

          -  participants taking insulin on QD or BID doses, stable for 3 months
Study to Evaluate Botulinum Neurotoxin Serotype E (EB-001) in Reducing Musculoskeletal Pain in Abdominoplasty
Condition: Abdominoplasty
MeSH terms: Musculoskeletal Pain
Intervention: Botulinum Neurotoxin Serotype E; Placebo
Intervention description: Single botulinum neurotoxin serotype E injection into RA muscles during abdominoplasty surgery.; Placebo (sterile saline solution 0.9% Sodium Chloride Injection) injected into RA muscles during abdominoplasty surgery.
Intervention MeSH terms: Botulinum Toxins
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 23.0
Sex: All
Minimum age: 23 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: pain, neurotoxin

Summary:

      To determine the safety and efficacy of single intra-operative treatment of Botulinum
      Neurotoxin Serotype E (EB-001) intramuscular (IM) injections into the Rectus Abdominus (RA)
      in participants undergoing abdominoplasty.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Men or women 23 to 55 years of age, inclusive

          2. Scheduled to undergo elective abdominoplasty surgery with full length plication from
             xyphoid to pubis, and removal of skin/fat flap under general anesthesia (endotracheal
             or otherwise) without liposuction

          3. American Society of Anesthesiologist (ASA) Physical Class 1-2.

        Exclusion Criteria:

          1. History of prior major abdominal surgery as judged by the investigator

          2. Pre-existing lung disease that could impact participant safety in the opinion of the
             investigator

          3. Pre-existing disorders of the neuromuscular junction (myasthenia gravis, Eaton-
             Lambert syndrome, or amyotrophic lateral Sclerosis)

          4. At high risk of deep vein thrombosis as judged by the investigators determined by a
             Caprini score of 3 or higher

          5. Slow vital capacity that is below 80% of normal value for respective race, age,
             height, and gender or below 2.5 Liters (L) of absolute volume

          6. Pulse oximetry below 95%

          7. Body weight less than 50 kg (110 pounds) or a Body Mass Index (BMI) of ≥ 32

          8. Reported use of any botulinum toxin within 3 months prior to the date of surgery

          9. Use of long acting opioids within 3 days or any opioid medication within 24 hours
             prior to surgery

         10. Aminoglycoside intake within 48 hours prior to or during surgery

         11. Participants on anti-depressant or anti-psychotic medications

         12. Reported pain score of 2 or more at screening on the 11-point scale numerical pain
             rating scale-administered after an activity (NPRS-A) following an activity after and
             walking approximately 10 feet.
Safety and Efficacy of Oral AGN 203818 for the Relief of Irritable Bowel Syndrome Pain
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome
Intervention: AGN 203818; AGN 203818; AGN 203818; placebo
Intervention description: Part A: 3 mg AGN203818 capsule every 12 hours for 4 weeks; Part A: 20 mg AGN203818 capsule every 12 hours for 4 weeks; Part A: 60 mg AGN203818 capsule every 12 hours for 4 weeks; Part A: placebo capsule every 12 hours for 4 weeks
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 213.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will explore the safety and effectiveness of different doses of AGN 203818 in
      relieving Irritable Bowel Syndrome pain. The study is being conducted in 2 parts. Part A
      enrolled 213 pts dosed with either 3, 20, 60 mg AGN 203818 or placebo over 4 week treatment
      duration. Part B will enroll 320 pts and dose with either 60, 100, 160 mg BID AGN 203818 or
      placebo over 12 week treatment duration.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of Irritable Bowel Syndrome

          -  Moderate or severe IBS pain

        Exclusion Criteria:

          -  Any other uncontrolled disease

          -  Pregnant or nursing females
HORIZANT (Gabapentin Enacarbil Extended-Release Tablets) for the Treatment of Alcohol Use Disorder
Condition: Alcohol Use Disorder
MeSH terms: Alcoholism; Alcohol Drinking
Intervention: gabapentin enacarbil; Placebo
Intervention description: Horizant Extended Release Tablets, 600 mg, white to off-white, oval shaped tablets, taken 2 times per day; Placebo tablet, white to off-white, oval shaped tablets, taken 2 times per day
Intervention MeSH terms: Gabapentin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 346.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No
Keywords: alcohol use disorder; alcoholism; alcohol dependence; drinking alcohol

Summary:

      The purpose of this study is to determine whether gabapentin enacarbil is effective in the
      treatment of problems with alcohol.
    

Eligibility criteria:

        Inclusion Criteria:

        Subjects must meet each one of the following inclusion criteria in order to be eligible for
        participation in the study:

          1. Be at least 21 years of age.

          2. Have a current (past 12 months) DSM-5 diagnosis of AUD.

          3. Have a BAC by breathalyzer equal to 0.000 when s/he signed the informed consent
             document (either just prior to or immediately after signing consent).

          4. Be seeking treatment for problems with alcohol.

        Additional will be evaluated in clinic.

        Exclusion Criteria:

        Evaluations will be conducted in clinic.
A Study of Bermekimab for the Treatment of Participants With Moderate to Severe Hidradenitis Suppurativa
Condition: Hidradenitis Suppurativa
MeSH terms: Hidradenitis Suppurativa; Hidradenitis
Intervention: Bermekimab; Adalimumab; Placebo
Intervention description: Bermekimab will be administered subcutaneously.; Adalimumab will be administered subcutaneously.; Placebo will be administered subcutaneously.
Intervention MeSH terms: Adalimumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 151.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the clinical efficacy of bermekimab in participants
      with moderate to severe Hidradenitis Suppurativa (HS).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have hidradenitis suppurativa (HS) for at least 1 year (365 days) prior to the
             baseline visit as determined by the investigator through participant interview and/or
             review of the medical history

          -  Have Hurley Stage II or Hurley Stage III HS as determined by the investigator at
             screening and baseline visits

          -  Have HS lesions present in at least 2 distinct anatomic areas (examples include but
             are not limited to left and right axilla; or left axilla and left inguinocrural fold)
             at screening and baseline visits

          -  Have a total abscess and inflammatory nodule (AN) count of greater than or equal to
             (>=) 5 at the screening and baseline visit

          -  Agree not to receive a live virus or live bacterial vaccination during the study and
             for 90 days after the last administration of study intervention

        Exclusion Criteria:

          -  Has a current diagnosis or signs or symptoms of severe, progressive, or uncontrolled
             renal, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic,
             hematologic, rheumatologic, psychiatric, or metabolic disturbances

          -  Has unstable cardiovascular disease, defined as a recent clinical deterioration (that
             is, unstable angina, rapid atrial fibrillation) in the last 3 months or a cardiac
             hospitalization within the last 3 months

          -  Has or has had herpes zoster within the 2 months before screening

          -  Has a transplanted organ (with exception of a corneal transplant greater than [>] 3
             months before the first administration of study intervention)

          -  Has known allergies, hypersensitivity, or intolerance to bermekimab or adalimumab or
             its excipients
AGN-199201 for the Treatment of Erythema With Rosacea
Condition: Rosacea; Erythema
MeSH terms: Rosacea; Erythema
Intervention: AGN-199201 Dose A; AGN-199201 Dose B; AGN-199201 Dose C; AGN-199201 Vehicle
Intervention description: AGN-199201 Dose A applied once or twice daily to the face for 28 days.; AGN-199201 Dose B applied once or twice daily to the face for 28 days.; AGN-199201 Dose C applied once or twice daily to the face for 28 days.; AGN-199201 Vehicle applied once or twice daily to the face for 28 days.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 357.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will evaluate the safety and efficacy of 3 doses of AGN-199201 once and twice
      daily compared to vehicle for the treatment of moderate to severe facial erythema associated
      with rosacea.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Redness of the skin caused by rosacea

        Exclusion Criteria:

          -  ≥3 inflammatory lesions

          -  Laser light-source or other energy based therapy in the last 6 months

          -  Any prescription or over the counter product for the treatment of acne or rosacea in
             the last 14 days
Study of Panobinostat in Combination With Bortezomib and Dexamethasone in Japanese Patients With Relapsed/Refractory Multiple Myeloma
Condition: Relapse/Refractory Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: LBH589 (panobinostat); bortezomib; dexamethasone
Intervention description: Panobinostat (PAN) capsules were supplied at dose strengths of 10 mg and 15 mg. and dosed at 20mg during treatment phase 1 (21 days) and treatment phase 2 (42 days); Bortezomib (BTZ) s.c: 1.3 mg/m2 was administered during both treatment phase 1 (21 days) & treatment phase 2 (42 days).; Dexamethasone (Dex): 20mg tablets taken during both treatment phase 1 (21 days & treatment phase 2 (42 days)
Intervention MeSH terms: Dexamethasone; Bortezomib; Panobinostat
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 31.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: LBH589; panobinostat; bortezomib; dexamethasone; Phase II; bortezomib and dexamethasone; Japanese patients; relapsed/refractory multiple myeloma; Panobinostat (PAN)

Summary:

      The purpose of this study was to evaluate the efficacy and safety of panobinostat in
      combination with bortezomib and dexamethasone in Japanese patients with relapsed/refractory
      multiple myeloma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient had a previous diagnosis of multiple myeloma

          -  Patient required retreatment for multiple myeloma

          -  Patient had measurable M component in serum or urine at study screening

        Exclusion Criteria:

          -  Primary refractory disease (patients that never reached at least an minor response for
             over 60 days under any prior therapy)

          -  Patient who had been treated by bortezomib before, and did not reach at least a minor
             response under this therapy, or progressed under it or within 60 days of last dose

          -  Patient received prior treatment with DAC inhibitors including panobinostat

          -  Patient had impaired cardiac function, or a prolonged QTc interval at screening ECG
Safety and Efficacy Study of a Protease Activated Receptor-4 Antagonist Being Tested to Reduce the Chances of Having Additional Strokes or "Mini Strokes"
Condition: Thrombosis
MeSH terms: Thrombosis
Intervention: BMS-986141; Aspirin; Placebo
Intervention MeSH terms: Aspirin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether BMS-986141 is effective in reducing the
      recurrence of stroke in people who recently had a stroke, or a transient ischemic attack
      (known as a TIA or "mini stroke") and are receiving acetylsalicylic acid (also known as
      aspirin or ASA) to treat the stroke or TIA.
    

Eligibility criteria:

        For more information regarding BMS clinical trial participation, please visit
        www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Male or female, age 18 or older

          -  Must have had a very recent stroke or transient ischemic attack ("mini stroke") that
             can be confirmed by the study doctor

          -  Able to be assigned to a study group no later than 48 hours after the stroke occurred

          -  Has an image of the brain that confirms that the stroke was not caused by hemorrhage
             or other reason that could explain symptoms

        Exclusion Criteria:

          -  A suspicion by the study doctor that the transient ischemic attack or stroke was
             caused by a blood clot that formed in the heart; examples of this include history of
             an abnormal heart rhythm known as atrial fibrillation or a ventricular aneurysm or
             defect of the heart.

          -  Any condition requiring treatment with an anticoagulant

          -  History of intracranial hemorrhage ("bleeding in the brain")

          -  Gastrointestinal ("stomach or intestinal") bleeding in the last 3 months that required
             treatment

          -  Planned or anticipated invasive surgery or procedure during the study

          -  Unable to tolerate MRI procedures.
Endoscopic Therapy of Early Cancer in Barretts Esophagus
Condition: Early Stage Esophageal Adenocarcinoma; Barrett Esophagus
MeSH terms: Barrett Esophagus
Intervention: Endoscopic Mucosal Resection; Photodynamic Therapy
Intervention description: Endoscopic mucosal resection at time of endoscopy if indicated.; Porfimer sodium 2mg/kg
Intervention MeSH terms: Dihematoporphyrin Ether
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 73.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study is being done to see if treatment for esophageal cancer can be done using
      endoscopy for patients ineligible for surgical or radiological therapy. The standard method
      of treating this type of cancer is surgical removal of the esophagus. The study will
      determine if removing just the cancer with endoscopy is enough treatment or if the addition
      of another treatment called photodynamic therapy (treatment with a red light and a drug
      called sodium porfimer) is needed.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Non-recurrent adenocarcinoma in Barrett's Esophagus confirmed by two experienced
             gastrointestinal pathologists

          -  No evidence of submucosal invasion

          -  No evidence of metastatic disease in either regional or distal lymph nodes, or other
             organs

          -  Pre-entry CT scans of the upper abdomen and chest and Endoscopic Ultrasound (EUS) of
             the tumor and regional lymph nodes are required. Fusion PET scans are suggested for
             any indeterminate lesions

          -  Zubrod Performance Status 0-1

          -  Participants must be have oral intake of greater than 1700 calories a day

          -  Patient must not have had a second malignancy, other than curable non-melanoma skin
             cancer or cervical cancer in situ, unless disease free for greater than or equal to 3
             years and deemed cured by their hematologist and/or oncologist

          -  Staging procedures should be performed prior to study entry

          -  All patients or legally authorized representative must sign a study-specific informed
             consent prior to randomization.

        Exclusion criteria:

          -  Prior major esophageal surgery

          -  Patients who are unable to tolerate endoscopic procedures

          -  Due to the possible toxic effects of photodynamic therapy and endoscopic sedation to
             embryos, pregnant or lactating women or men unable or unwilling to practice
             contraception are excluded

          -  Patients with an uncontrolled diabetes, heart disease, or hypertension

          -  Patient and/or legally authorized representative who are unable to comprehend the
             study requirements or who are not likely to comply with the study parameters.