bioihbjkbjnl/mcl2 huggingface dataset:
Real-World AR101 Market-Supporting Experience Study in Peanut-Allergic Children (RAMSES)
Condition: Peanut Allergy
MeSH terms: Peanut Hypersensitivity
Intervention: AR101; Placebo
Intervention description: AR101 powder provided in capsules; Placebo powder provided in capsules
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 2:1 randomization to AR101 or placebo
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 506.0
Sex: All
Minimum age: 4 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: AR101; Characterized Peanut Allergen; CPNA (Characterized Peanut Allergen); OIT (oral immunotherapy); Peanut Allergy; Peanut-Allergic Children; Desensitization; ARC007; Characterized Oral Desensitization Immunotherapy (CODIT™)

Summary:

      This is a multicenter, randomized, double-blind, placebo-controlled safety study of AR101
      using the characterized oral desensitization immunotherapy (CODIT™) regimen in
      peanut-allergic children.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Ages 4 to 17 years, inclusive

          -  History of physician-diagnosed peanut allergy that includes allergic signs and
             symptoms within two hours of known oral exposure to peanut

          -  Mean peanut wheal diameter on SPT of at least 8mm and elevated psIgE of at least 14
             kUA/L at screening

          -  Written informed consent from the subject's parent/guardian

          -  Written assent from the subject as appropriate (per local regulatory requirements)

          -  Use of effective birth control by sexually active female subjects of childbearing
             potential

        Key Exclusion Criteria:

          -  Subjects in whom the clinical diagnosis of peanut allergy is uncertain

          -  Severe or uncontrolled asthma

          -  History of cardiovascular disease, including uncontrolled or inadequately controlled
             hypertension

          -  History of severe or life-threatening episode of anaphylaxis or anaphylactic shock
             within 60 days of screening

          -  History of eosinophilic esophagitis (EoE), other eosinophilic gastrointestinal
             disease, chronic, recurrent, or severe gastroesophageal reflux disease (GERD),
             symptoms of dysphagia or recurrent gastrointestinal symptoms of undiagnosed etiology

          -  History of a mast cell disorder, including mastocytosis, urticaria pigmentosa, chronic
             idiopathic or chronic physical urticaria beyond simple dermatographism (e.g., cold
             urticaria, cholinergic urticaria), and hereditary or idiopathic angioedema

          -  Any other condition that, in the opinion of the Investigator, precludes participation
             for reasons of safety
Comparison of Bowel Cleansing Efficacy Between Same-day Dose Versus Split Dose
Condition: Unrecognized Condition
Intervention: Polyethylene Glycol (PEG)
Intervention description: Different method for bowel cleansing using same bowel cleanser. Same-day dose group : 4L PEG will be ingested on the day of colonoscopy Spli-dose group : 2L PEG will be ingested 1 day before colonoscopy, remaining 2L PEG will be ingested on the day of colonoscopy
Phase: Phase 3
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Enrollment: 352.0
Sex: All
Minimum age: 40 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Split dose bowel cleansing is recommended method for colonoscopy. For afternoon colonoscopy,
      same-day dose of bowel cleansing is alternative option. Recently, same-day bowel cleansing
      for morning colonoscopy was validated. To date, there was no study which compared the bowel
      cleansing efficacy between same-day dose and split dose regardless of colonoscopy time. The
      aim of current study is to compare the bowel cleansing efficacy, adverse events, and
      patient's tolerability between the two group.

      Subjects who underwent colonoscopy for various reasons were included. After agreeing to
      participate in the study, study participants were randomly assigned to split dose or same day
      dose group. Bowel cleansing is done using polyethylene glycol (PEG). All colonoscopy was done
      between 10 AM to 6 PM. Study participants were instructed to ingest 500ml PEG every 15
      minutes. Subjects who were assigned to split dose group ingested 2L PEG from 9PM 1 day before
      colonoscopy. Remaining 2L PEG was ingested 3-5 hours before colonoscopy. In the same-day dose
      group, bowel cleansing was started from 5AM for subjects who were scheduled to receive
      colonoscopy in the morning. Afternoon colonoscopy group in the same-day dose group ingested
      2L PEG from 5AM. Remaining 2L PEG was finished 3-5 hours before colonoscopy.

      Bowel cleansing efficacy was assessed using Boston bowel preparation scale. Vital signs and
      laboratory tests were checked before colonoscopy. Study participants completed questionnaire
      which contained patient's satisfaction, tolerability, and adverse event during bowel
      cleansing. Bowel cleansing efficacy, patient's tolerability, and safety profile were compared
      between the two groups. Successful bowel cleansing was estimated 85% for split dose group.

      The investigators set 10% for inferior margin. Considering 10% drop out, a total of 352
      subjects will be recruited.
    

Eligibility criteria:

        Inclusion Criteria:

          -  all subjects who undergo colonoscopy for various reasons.

        Exclusion Criteria:

          -  hemodynamic instability

          -  ileus or bowel obstruction

          -  active inflammatory bowel disease

          -  advanced colon cancer
Contrast-enhanced Ultrasound Evaluation of Chemoembolization
Condition: Hepatocellular Carcinoma; Chemoembolization, Therapeutic
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Intervention: Ultrasound contrast agent (Contrast-enhanced ultrasound); Logiq E9 Scanner (Contrast-enhanced ultrasound)
Intervention description: Intravenous injection of ultrasound contrast agent followed by saline flush though an angiocatheter in the arm or hand.; Ultrasound scanning using a commercial scanner with a C1-5-D broad-spectrum convex transducer followed by a RAB2-5-D broad-spectrum real-time 4D transducer.
Phase: Phase 3
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 131.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No

Summary:

      The primary objective of this trial is to evaluate the sensitivity and specificity of 2D and
      4D contrast enhanced ultrasound for monitoring transarterial chemoembolization (TACE)
      response 1-2 weeks and 1 month post treatment as an alternative to contrast-enhanced magnetic
      resonance (MRI) or computed tomography (CT) imaging
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients >= 21 years of age

          -  Patient capable of making informed decisions regarding his/her treatment

          -  Scheduled for TACE treatment of a HCC mass (lesions reported as Liver Imaging
             Reporting and Data Systems 4B or 5 or Organ Procurement and Transplantation Network 5a
             or 5b)

          -  Negative pregnancy test in a female of child-bearing age.

          -  Have an HCC mass viewable on grayscale B-mode ultrasound.

        Exclusion Criteria:

          -  Females who are pregnant or nursing.

          -  Patients not eligible or scheduled for TACE of a HCC mass.

          -  Patients who have received an investigational drug in the 30 days before study drug
             administration, or will receive one within 72 h after their final CEUS exam.

          -  Patients who have received prior radioembolization (Y90) of the lesion of interest.

          -  Patients with known or suspected cardiac shunts.

          -  Patients with pulmonary hypertension or unstable cardiopulmonary conditions.

          -  Patients who are medically unstable, patients who are seriously or terminally ill, and
             patients whose clinical course is unpredictable. For example:

          -  Patients with unstable occlusive disease (e.g., crescendo angina)

          -  Patients with clinically unstable cardiac arrhythmias

          -  Patients with uncontrolled congestive heart failure (NYHA Class IV)
Safety and Efficacy of Reduced Versus Standard Dose Efavirenz (EFV) Plus Two Nucleotides in Antiretroviral-naïve Adults.
Condition: HIV Infections
MeSH terms: HIV Infections
Intervention: Efavirenz 600mg; Efavirenz 400mg
Intervention description: 3 x EFV 200 milligram (mg) tablets once daily; 2 x EFV 200 milligram (mg) tablets plus 1x matched EFV placebo tablet once daily
Intervention MeSH terms: Efavirenz
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 636.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: No
Keywords: HIV; Antiretroviral Therapy (ART); Efavirenz (EFV); Dose reduction

Summary:

      Clinical data suggests that the standard dose of the anti-HIV medication, efavirenz (EFV),
      could be reduced without compromising its effectiveness. Lower drug doses could have fewer
      side effects and would make EFV more affordable. The purpose of this study is to compare the
      safety and effectiveness, over 96 weeks, of standard (600mg) versus reduced dose (400mg) EFV
      in controlling HIV as part of initial combination antiretroviral therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  HIV-1 positive by licensed diagnostic test

          -  aged >16 years of age (or minimum age as determined by local regulations or as legal
             requirements dictate)

          -  50 < cluster of differentiation (CD)4 <500 cells/µL

          -  No prior AIDS-defining illness, using the Center for Diseases Control 1993 Case
             Definition (except pulmonary tuberculosis)

          -  HIV RNA ≥1000 copies/mL

          -  no prior exposure to antiretroviral therapy (ART) (including short course ART for
             preventing MTCT)

          -  calculated creatinine clearance (CLCr) more than or equal to 50 mL/min
             (Cockcroft-Gault formula)

          -  provision of written informed consent.

        Exclusion Criteria:

          -  the following laboratory values:

               -  absolute neutrophil count (ANC) <500 cells/μL

               -  hemoglobin <7.0 g/dL

               -  platelet count <50,000 cells/μL

               -  alanine aminotransferase and/or aspartate aminotransferase >5 x upper limit of
                  normal

          -  pregnant women or nursing mothers

          -  active opportunistic or malignant disease not under adequate control

          -  use of immunomodulators within 30 days prior to screening

          -  use of any prohibited medications

          -  current alcohol or illicit substance use that might adversely affect study
             participation
Prospective Biomarkers of Bone Metabolism in Hemophilia A
Condition: Hemophilia; Bone Disease
MeSH terms: Bone Diseases; Hemophilia A
Intervention: Advate
Intervention description: Patients who are currently taking Advate as their factor replacement will be eligible for the 5-day study.
Intervention MeSH terms: Factor VIII
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: Male
Minimum age: 16 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: hemophilia; bone disease; clinical study; biomarkers

Summary:

      One of the major shortcomings in studying bone disease in hemophilia is the lack of fracture
      outcome data demonstrating the clinical significance of decreased BMD and altered bone
      biomarkers in the hemophilia population. This study demonstrates that PwH have an increased
      risk of fracture compared to the general population and that the issue of bone health will
      increase in importance as the PwH population ages.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Males with a diagnosis of hemophilia A with a historic baseline FVIII level ≤ 2%.

          2. Age > 16 years old

          3. Currently using ADVATE as FVIII replacement therapy

        Exclusion Criteria:

          1. Subject or guardian is unwilling or unable to give written informed consent and/or
             assent

          2. Joint or muscle bleeding within 2 weeks of Study Day 1

          3. Presence of a current factor inhibitor (>0.6 BU/mL via Nijmegan-modified Bethesda
             assay)

          4. Known collagen vascular bone disease.
Evaluation of Safety and Efficacy of PDP-716
Condition: Open Angle Glaucoma; Ocular Hypertension
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension
Intervention: Brimonidine Tartrate Ophthalmic Suspension; Brimonidine Tartrate Ophthalmic Solution
Intervention description: PDP-716; Three Times Brimonidine Tartrate Ophthalmic Solution
Intervention MeSH terms: Brimonidine Tartrate; Ophthalmic Solutions
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 682.0
Sex: All
Minimum age: 2 Years
Healthy volunteers: No

Summary:

      The study will be conducted to evaluate the efficacy and safety of topical administration of
      PDP-716 compared with brimonidine tartrate ophthalmic solution.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Be male or female, of 2 years of age or older

          2. Have open-angle glaucoma or ocular hypertension in both the eyes

          3. Be able and willing to follow study instructions and complete all required visits.

        Exclusion Criteria:

          1. Females who are pregnant/lactating.

          2. Have uncontrolled systemic disease which might interfere with the study

          3. Any known allergy or sensitivity to the study medications or their components

          4. Any other clinically relevant abnormality
Efficacy and Safety of Cadazolid Versus Vancomycin in Subjects With Clostridium Difficile - Associated Diarrhea
Condition: Clostridium Difficile Infection
MeSH terms: Clostridium Infections; Diarrhea
Intervention: Cadazolid; Vancomycin; Cadazolid-matching placebo; Vancomycin-matching placebo
Intervention description: Cadazolid 250 mg as oral suspension twice daily.; Vancomycin 125 mg as oral capsules 4 times daily.; Placebo matching cadazolid and administered orally twice daily; Placebo capsules matching vancomycin and administered orally 4 times per day
Intervention MeSH terms: Vancomycin; Oxazolidinones
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 632.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Post-antibiotic diarrhea; Clostridium difficile infection

Summary:

      This clinical study is conducted to assess the efficacy of cadazolid compared to vancomycin
      in subjects with Clostridium difficile-associated diarrhea (CDAD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed Informed Consent.

          -  Male or female ≥ 18 years of age. Females of childbearing potential must agree to use
             an adequate and reliable method of contraception.

          -  Subject with a diagnosis of mild-moderate or severe CDAD (first occurrence or first
             recurrence within 3 months) with: Diarrhea: a change in bowel habits with > 3 liquid
             or unformed bowel movements (UBM) within 24 hours prior to randomization, AND Positive
             C. difficile toxin test on a stool sample produced within 72 hours prior to
             randomization.

        Exclusion Criteria:

          -  More than one previous episode of CDAD in the 3-month period prior to randomization.

          -  Evidence of life-threatening or fulminant CDAD.

          -  Likelihood of death within 72 hours from any cause.

          -  History of inflammatory colitides, chronic abdominal pain, or chronic diarrhea.

          -  Antimicrobial treatment active against CDAD administered for > 24 hours except for
             metronidazole treatment failures (MTF)

          -  Known hypersensitivity or contraindication to study drugs, oxazolidinones, or
             quinolones.

          -  Unable or unwilling to comply with all protocol requirements.

          -  Any circumstances or conditions, which, in the opinion of the investigator, may affect
             full participation in the study or compliance with the protocol
Safety And Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir Fixed-Dose Combination for 12 Weeks in Adults Who Participated in a Prior Gilead-Sponsored HCV Treatment Study
Condition: Hepatitis C Virus Infection
MeSH terms: Hepatitis C
Intervention: SOF/VEL/VOX
Intervention description: 400/100/100 mg FDC tablet administered orally once daily with food
Intervention MeSH terms: Velpatasvir
Phase: Phase 3
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

Summary:

      The primary objectives of this study are to determine the efficacy, safety, and tolerability
      of treatment with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed-dose combination
      (FDC) for 12 weeks in participants with chronic hepatitis C virus (HCV) infection with or
      without cirrhosis, who did not achieve sustained viral response (SVR) after receiving prior
      treatment in a Gilead-sponsored HCV treatment study of direct-acting antiviral
      (DAA)-containing regimens.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Chronically HCV-infected males and non-pregnant/non-lactating females aged 18 years or
             older who did not achieve sustained virologic response (SVR) in a prior
             Gilead-sponsored HCV treatment study

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Examination of Bromocriptine on Homeostatic and Hedonic Mechanisms of Food Intake in Individuals at High Risk for T2DM
Condition: Overweight and Obesity; Eating Behavior
MeSH terms: Overweight
Intervention: Placebo; Bromocriptine-QR
Intervention description: 2 capsules, orally administered once; 1.6mg (2 0.8mg capsules), orally administered once
Intervention MeSH terms: Bromocriptine
Phase: Phase 3
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Participants are randomly assigned to one of two possible intervention arms (active drug vs. placebo) at baseline. Following a 2-week washout period, participants receive the other intervention.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 55.0
Sex: All
Minimum age: 18 Years
Maximum age: 35 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: bromocriptine; dopamine agonist; TaqIA polymorphism; eating behavior; food intake; overweight; obesity

Summary:

      The current project applies an integrative three-prong approach to investigate the potential
      of the dopamine D2 receptor (DRD2) agonist bromocriptine to: 1) increase homeostatic
      satiation signaling, 2) alter neural circuitry to reduce hedonically motivated food intake,
      and 3) examines a genetic predisposition that may markedly impact the effectiveness of this
      medication in those at high risk for T2DM.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Baseline BMI between 25 and 35

        Exclusion Criteria:

          -  Individuals with current fMRI contraindications (e.g., metal implants, braces)

          -  Probable current Axis I psychopathology (e.g., major depression disorder, panic
             disorder, generalized anxiety disorder, bipolar disorder)

          -  Habitual use of cigarettes or illicit drugs

          -  Pregnancy or breastfeeding

          -  Diagnosis of serious medical problems (e.g., diabetes, cardiovascular disease, stroke)

          -  Current weight loss dieting and/or weight fluctuations great than 10 lbs in the
             previous 6 weeks

          -  Do not consume dairy

          -  Allergy to bromocriptine, dairy, and nuts
A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes Not Controlled With Diet and Exercise Alone
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Tirzepatide; Placebo
Intervention description: Administered SC; Administered SC
Intervention MeSH terms: Tirzepatide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 478.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: glucose-dependent insulinotropic polypeptide (GIP); glucagon-like peptide-1 (GLP-1); GIP/GLP-1 dual receptor agonist; T2DM

Summary:

      The goal for this study is to evaluate the efficacy and safety of tirzepatide versus placebo
      in participants with type 2 diabetes not under control with diet and exercise alone. The
      study will last approximately 47 weeks and may include about 15 visits.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have been diagnosed with type 2 diabetes mellitus (T2DM).

          -  Are naïve to diabetes injectable therapies and have not used any oral
             antihyperglycemic medications (OAMs) during the 3 months preceding screening.

          -  Have HbA1c between ≥7.0% and ≤9.5%.

          -  Be of stable weight (± 5%) for at least 3 months before screening.

          -  Have a BMI ≥23 kilograms per meter squared (kg/m²) at screening.

        Exclusion Criteria:

          -  Have type 1 diabetes mellitus.

          -  Have had chronic or acute pancreatitis any time prior to study entry.

          -  Have proliferative diabetic retinopathy or diabetic maculopathy or nonproliferative
             diabetic retinopathy requiring acute treatment.

          -  Have disorders associated with slowed emptying of the stomach, or have had any stomach
             surgeries for the purpose of weight loss.

          -  Have an estimated glomerular filtration rate <30 mL/minute/1.73 m².

          -  Have had a heart attack, stroke, or hospitalization for congestive heart failure in
             the past 2 months.

          -  Have a personal or family history of medullary thyroid carcinoma or personal history
             of multiple endocrine neoplasia syndrome type 2.

          -  Have been taking weight loss drugs, including over-the-counter medications during the
             last 3 months.