bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy & Safety of STG320 Sublingual Tablets of HDM Allergen Extracts in Adults and Adolescents With HDM-associated AR
Condition: Rhinitis, Allergic, Perennial; House Dust Mite Allergy
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial; Dust Mite Allergy
Intervention: 300 IR; Placebo
Intervention description: 300 IR tablet of HDM Allergen Extracts; Placebo tablet
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1607.0
Sex: All
Minimum age: 12 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The objective of this study was to assess the efficacy and safety of 12 months of treatment
      with 300 IR of STG320 sublingual tablets compared with placebo in adults and adolescents with
      HDM-associated allergic rhinitis.
    

Eligibility criteria:

        Main Inclusion Criteria:

          -  Patients with HDM-associated allergic rhinitis (AR) for at least 1 year

          -  Patients sensitized to D. pteronyssinus (D. pte) and/or D. farinae (D. far) defined on
             skin prick test and HDM-specific serum IgE

        Main Exclusion Criteria:

          -  A history of rhinitis, rhinoconjunctivitis or asthma to allergens other than HDM,
             likely to result in rhinitis symptoms during the evaluation periods

          -  Partly controlled or uncontrolled asthma

          -  Controlled asthma requiring controller treatment(s) consistent with GINA 2014
             treatment Steps 3 to 5
Inositol to Reduce Retinopathy of Prematurity
Condition: Retinopathy of Prematurity (ROP)
MeSH terms: Retinal Diseases; Retinopathy of Prematurity; Premature Birth
Intervention: myo-Inositol 5% Injection; Placebo
Intervention description: Abbott Nutrition Division, Abbott Laboratories is supplying myo-Inositol 5% Injection to the clinical centers for the duration of the trial.
Inositol: myo-Inositol 5% Injection is an isotonic, preservative-free, sterile 5% solution of myo-inositol in water containing 0.5 gm sodium chloride per liter (8.55mM), pH 6.5-7.5. It is administered via IV infusion using syringe pump over 15-30 minutes twice per day at 12-hour intervals at a dose of 80 mg inositol/kg/day (40 mg inositol/kg/dose), which is equivalent to 1.6 mL/kg/day (0.80 mL/kg/dose).; % glucose(dextrose)
Intervention MeSH terms: Inositol
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 638.0
Sex: All
Minimum age: 12 Hours
Maximum age: 72 Hours
Healthy volunteers: No
Keywords: Retinopathy; Prematurity; Infant, Newborn, Diseases

Summary:

      This is a Phase 3, randomized, double-masked, placebo-controlled study designed to determine
      the effectiveness of myo-Inositol 5% Injection to increase the incidence of survival without
      severe Retinopathy of Prematurity (ROP) through acute/final ROP determination up to 55 weeks
      postmenstrual age (PMA) in premature infants <28 0/7 weeks' gestation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Inborn or out born infants of either gender or any race with best obstetrical estimate
             of gestation <28 weeks (27 6/7 weeks and younger). Gestational age will be determined
             by best obstetrical estimate using the hierarchy of best obstetrical estimate using
             early ultrasound dating, maternal menstrual dating confirmed by examination, or
             neonatal gestational age assessment by physical examination.

          -  Alive at 12 hours.

          -  Age in hours up to 72 hours, although we will seek enrollment as early as feasible
             after consent and 12 hours.

          -  Informed consent signed and dated by parent and/or guardian, which includes likelihood
             of completing follow-up ophthalmic examinations as an outpatient, and long-term
             follow-up.

        Exclusion Criteria

          -  Major congenital malformations

          -  Congenital malformations of the eye identified prior to randomization.

          -  Overt evidence of intrauterine congenital infections ("TORCH") or life threatening
             impairment of renal, hepatic, or cardiac function (considered moribund).
Phase 3 Trial in Squamous Non Small Cell Lung Cancer Subjects Comparing Ipilimumab Plus Paclitaxel and Carboplatin Versus Placebo Plus Paclitaxel and Carboplatin
Condition: Lung Cancer (NSCLC)
MeSH terms: Lung Neoplasms
Intervention: Paclitaxel; Carboplatin; Ipilimumab; Placebo
Intervention description: 0.9% sodium chloride injection, USP, or 5% dextrose injection
Intervention MeSH terms: Paclitaxel; Carboplatin; Ipilimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 342.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of the study is to determine whether Ipilimumab plus Paclitaxel and Carboplatin
      will extend the life of patients with squamous only non small cell lung cancer more than
      placebo plus Paclitaxel and Carboplatin.
    

Eligibility criteria:

        For more information regarding BMS clinical trial participation, please visit
        www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Subjects with NSCLC of predominantly squamous histology documented by histology or
             cytology from brushing, washing or needle aspiration of a defined lesion but not from
             sputum cytology alone

          -  Stage IV or Recurrent NSCLC (per the 7th International Association for the Study of
             Lung Cancer (IASLC) classification)

          -  At least 1 measurable tumor lesion, as defined by mWHO criteria, that is not located
             in a previously irradiated area

          -  Eastern Cooperative Oncology Group (ECOG) performance status ≤1

        Exclusion Criteria:

          -  Brain metastases

          -  Malignant pleural effusion that is recurrent

          -  Documented history of severe autoimmune or immune mediated symptomatic disease that
             required prolonged (more than 2 months) systemic immunosuppressive (ie, steroids)
             treatment
Colchicine/Statins for the Prevention of COVID-19 Complications (COLSTAT) Trial
Condition: SARS-CoV-2
Intervention: Standard of Care (SOC) and Colchicine+Rosuvastatin
Intervention description: Patients will take Rosuvastatin 40mg daily and Colchicine 0.6mg twice for 3 days and then 0.6mg daily during hospitalization
Intervention MeSH terms: Colchicine; Rosuvastatin Calcium
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 250.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Rosuvastatin; Colchicine

Summary:

      This is a pragmatic randomized open-label study of the safety and efficacy of the combination
      of colchicine and Rosuvastatin in addition to standard of care (SOC) compared to SOC alone in
      hospitalized patients with SARS-CoV-2
    

Eligibility criteria:

        Inclusion Criteria 1.18 years or older and confirmed SARS-CoV-2 infection by RT-PCR 2.
        Patient is admitted to the floor (non-ICU) within 48 hours of hospital admission 3. The
        patient, or legally authorized representative, has been informed of the nature of the
        study, agrees to its provisions and has provided witnessed (by 2 independent members of the
        health care team) oral informed consent, or a photograph of the signed informed consent
        approved by the Institutional Review Board (IRB)

        Exclusion Criteria:

          1. Known pregnancy or nursing mothers

          2. Known allergy to statins or colchicine

          3. Patient is on chronic colchicine or oral corticosteroid treatment

          4. Acute liver disease defined by elevated transaminases (AST/ALT > 3x ULN)

          5. Severe chronic kidney disease defined as glomerular filtration rate (GFR) <
             30mL/min1.73 m2

          6. Severe QTc prolongation (>500ms narrow QRS<120ms and >550ms for wide QRS>120)

          7. Presents with severe disease on admission (WHO ordinal scale of clinical improvement
             scores 5-8)

          8. Rhabdomyolysis or CPK > 5x ULN

          9. Thrombocytopenia defined as platelet count < 50,000 / mm3

         10. Leukopenia defined as white blood cell count < 3000 ml

         11. Severe anemia defined as Hemoglobin value <8 g/100ml

         12. Participation in any other clinical trial of an experimental treatment for COVID-19
A Study of the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Intervention: placebo for risankizumab; risankizumab IV; risankizumab SC
Intervention description: Placebo for risankizumab administered by intravenous infusion; Risankizumab administered by intravenous infusion; Risankizumab administered by subcutaneous (SC) injection
Intervention MeSH terms: Antibodies, Monoclonal
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 931.0
Sex: All
Minimum age: 16 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Crohn's Disease (CD); Risankizumab; ABBV-066; BI 655066

Summary:

      The purpose of this study is to evaluate the efficacy and safety of risankizumab versus
      placebo during induction therapy in participants with moderately to severely active Crohn's
      disease (CD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female aged >=18 to <= 80 years, or minimum age of adult consent according to
             local regulations, at the Baseline Visit. Where locally permissible, participants 16
             to < 18 years of age who meet the definition of Tanner stage 5 for development at the
             Baseline Visit.

          -  Diagnosis of CD for at least 3 months prior to Baseline.

          -  Confirmed diagnosis of moderate to severe CD as assessed by stool frequency (SF),
             abdominal pain (AP) score, and Simple Endoscopic Score for Crohn's Disease (SES-CD).

          -  Demonstrated intolerance or inadequate response to conventional or to biologic therapy
             for CD.

          -  If female, participant must meet the contraception recommendations.

        Exclusion Criteria:

          -  Participant with a current diagnosis of ulcerative colitis or indeterminate colitis.

          -  Participants with unstable doses of concomitant Crohn's disease therapy.

          -  Receipt of Crohn's disease approved biologic agents (infliximab, adalimumab,
             certolizumab, vedolizumab, natalizumab within 8 weeks prior to Baseline or ustekinumab
             within 12 weeks prior to Baseline), or any investigational biologic or other agent or
             procedure within 35 days or 5 half-lives prior to Baseline, whichever is longer.

          -  Prior exposure to p19 inhibitors (e.g., risankizumab).

          -  Complications of Crohn's disease.

          -  Having an ostomy or ileoanal pouch.

          -  Known active Coronavirus Disease 2019 (COVID-19) infection.
A Study of Palbociclib (PD-0332991) + Letrozole vs. Letrozole For 1st Line Treatment Of Postmenopausal Women With ER+/HER2- Advanced Breast Cancer (PALOMA-2)
Condition: Breast Neoplasms
MeSH terms: Breast Neoplasms
Intervention: PD-0332991; Letrozole; Placebo; Letrozole
Intervention description: PD-0332991, 125mg, orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment; Letrozole, 2.5mg, orally once daily (continuously); Placebo, 125mg, orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment; Letrozole, 2.5mg, orally once daily (continuously)
Intervention MeSH terms: Letrozole; Palbociclib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 666.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: breast cancer; postmenopausal women; estrogen-receptor positive; HER2 negative; locoregionally recurrent; metastatic; Palbociclib (PD-0332991); PALOMA-2

Summary:

      The study is designed to compare the clinical benefit following treatment with letrozole in
      combination with PD-0332991 versus letrozole in combination with placebo in postmenopausal
      women with ER(+)/HER2(-) advanced breast cancer who have not received prior systemic anti
      cancer therapies for their advanced/metastatic disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult women with locoregionally recurrent or metastatic disease not amenable to
             curative therapy.

          -  Confirmed diagnosis of ER positive breast cancer

          -  No prior systemic anti-cancer therapy for advanced ER+ disease.

          -  Postmenopausal women

          -  Measurable disease as per Response Evaluation Criterion in Solid Tumors [RECIST] or
             bone-only disease

          -  Eastern Cooperative Oncology Group [ECOG] 0-2

          -  Adequate organ and marrow function

          -  Patient must agree to provide tumor tissue

        Exclusion Criteria:

          -  Confirmed diagnosis of HER2 positive disease

          -  Patients with advanced, symptomatic, visceral spread that are at risk of life
             threatening complication in the short term

          -  Known uncontrolled or symptomatic CNS metastases

          -  Prior (neo)adjuvant treatment with letrozole or anastrozole with DFI ≤ 12-months from
             completion of treatment.

          -  Prior treatment with any CDK 4/6 inhibitor.
Study of Safety and Efficacy of an Oral Contraceptive
Condition: Prevention of Pregnancy
Intervention: Norethindrone Acetate/Ethinyl Estradiol 24 Days; Norethindrone Acetate /Ethinyl Estradiol 21 Days
Intervention description: One tablet per day for 24 days of each 28 day cycle followed by 4 placebo tablets; One tablet per day for 21 days of each 28 day cycle followed by 7 placebo tablets
Intervention MeSH terms: Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Ethinyl Estradiol; Norethindrone; Norethindrone Acetate; Estradiol; Polyestradiol phosphate
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 938.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Contraception

Summary:

      This is a comparative study. The primary objective of the study is to assess the efficacy of
      a low dose oral contraceptive in the prevention of pregnancy. The secondary objectives are to
      assess the incidence of intracyclic bleeding of norethindrone acetate/ethinyl estradiol
      (NETA/EE) administered for 24 days and NETA/EE administered for 21 days; and to assess the
      safety and tolerability of the product.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy Women

          -  Age 18-45

          -  At risk for pregnancy

          -  History of regular cycles

        Exclusion Criteria:

          -  Contraindications for use of hormonal contraception

          -  Conditions which affect the absorption or metabolism of steroid hormones

          -  BMI > 35
Clinical Study to Evaluate Efficacy of New Paracetamol Formulation Compared to Ibuprofen in Headache
Condition: Pain
MeSH terms: Headache
Intervention: Paracetamol and Caffeine; Ibuprofen; Placebo
Intervention description: Caplets containing 500 milligrams (mg) of paracetamol and 65 mg of caffeine; Caplets containing 200 mg of ibuprofen; Matching placebo caplets
Intervention MeSH terms: Acetaminophen; Ibuprofen; Caffeine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 365.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this multi-center study is to assess the efficacy of headache relief of new
      paracetamol/caffeine formulation compared to placebo and ibuprofen in episodic tension-type
      headache (ETTH).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants in good general health, and with diagnosis of ETTH with following
             conditions:

               1. number of days with the condition is historically greater than or equal to two
                  per month;

               2. severity of headaches is historically at least moderate;

               3. duration of headaches is historically more than or equal to 4 hours, if
                  untreated.

                  Exclusion Criteria:

          -  Participant with known or suspected hypersensitivity, allergy, intolerance or
             contraindication to the use of any of the study medications

          -  Participant has chronic tension type headache, psychiatric disease or a significant
             cognitive disorder, or any chronic pain disorder.

          -  Participant currently taking or has taken medications or herbal supplements within the
             three months that are likely to interfere with the validity of subject-rated
             assessments.
MK0954 Versus Placebo for Treatment of Mild to Moderate Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Intervention: losartan potassium; Comparator: placebo
Intervention description: losartan tablet (MK0954) 25 or 50 mg q.a.m. or 25 mg b.i.d., for 12 weeks; placebo to losartan tablet q.a.m. , for 12 weeks
Intervention MeSH terms: Losartan
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 428.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No

Summary:

      The study had a 4 week single blind placebo period followed by 12 weeks of double blind
      treatment. Patients were randomized to one of four treatment arms to evaluate the
      antihypertensive efficacy of Losartan.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient has been diagnosed with mild to moderate hypertension

          -  Patient has no treatment or active medical problem, other than hypertension that might
             affect the patients blood pressure

        Exclusion Criteria:

          -  Pregnant of lactating female patients

          -  Secondary hypertension or history of malignant hypertension

          -  Sitting systolic blood pressure > 210 mmHg

          -  History of stroke

          -  History of myocardial infarction with in the past year

          -  Current of prior history of heart failure

          -  Known hypersensitivity to losartan

          -  Obesity

          -  Patients known to be HIV positive or known to be positive for Hepatitis B

          -  Absence of one kidney

          -  Patient is abusing or previously abused alcohol or drugs with in past two years
Open Label Extension to Bridging Study CTBM100C2303
Condition: Pseudomonas Aeruginosa; Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Intervention: Tobramycin inhalation powder
Intervention description: Tobramycin inhalation powder, 112 mg (4 capsules of 28 mg), inhalation capsules, b.i.d.
Intervention MeSH terms: Tobramycin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 55.0
Sex: All
Minimum age: 6 Years
Maximum age: 21 Years
Healthy volunteers: No
Keywords: Tobramycin Inhalation Powder; Cystic fibrosis; Lung diseases; Anti-Bacterial Agents

Summary:

      This was an open-label, single arm (uncontrolled) study in participants suffering from cystic
      fibrosis, who had completed their study participation in CTBM100C2303 (all visits) and who
      were proven infected with Pseudomonas aeruginosa (P. aeruginosa) at enrollment into
      CTBM100C2303.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Completed all visits in study CTBM100C2303, and visit 4 took place not more than 5
             days before enrollment into this study.

          -  Confirmed diagnosis of cystic fibrosis participants with P. aeruginosa infection.

          -  Forced Expiratory Volume in One Second (FEV1) at screening (study CTBM100C2303) must
             be between 25% and 80% of normal predicted values.

        Exclusion Criteria:

          -  Any use of inhaled anti-pseudomonal antibiotics between the termination of the core
             trial CTMB100C2303 and the enrollment into this study.

          -  Known local or systemic hypersensitivity to aminoglycosides or inhaled antibiotics.
Nicotine Mouth Film for Craving Relief.
Condition: Smoking Cessation
Intervention: Nicotine
Intervention description: Comparison of different dosage forms of nicotine
Intervention MeSH terms: Nicotine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 320.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: provoked craving

Summary:

      Nicotine mouth film is a new dosage form of nicotine replacement therapy. The purpose of this
      study is to investigate the craving relief efficacy of nicotine mouth film by comparing mint
      nicotine mouth film to nicotine lozenge in light smokers using the provoked craving model.
      The cues used to provoke a craving episode will be the sight and smell of a lit cigarette and
      the manipulations required to light a cigarette. The smokers will be denied access to
      cigarettes for 4 hours prior to the provoked craving session in order to precipitate nicotine
      withdrawal and an increase level of cigarette craving.
    

Eligibility criteria:

        Inclusion Criteria:

          -  BMI within the range of 19-35 kg/m2;

          -  Current cigarette smokers who have smoked regularly daily for at least a year,

          -  Participants who smoke their first cigarette more than 30 minutes after waking up

        Exclusion Criteria:

          -  Known or suspected intolerance or hypersensitivity to nicotine (or closely related
             compounds) or any of the stated ingredients in formulation.

          -  Any participant whose CO level rises during the sequestration period (i.e., the
             subject's two expired CO assessments immediately prior to the provoked craving
             paradigm are higher than the mean baseline CO assessment) and, in the opinion of the
             investigator, may have smoked during that time.