bioihbjkbjnl/mcl2 huggingface dataset:
Prevention of Malaria in HIV-uninfected Pregnant Women and Infants
Condition: Malaria
MeSH terms: Malaria
Intervention: Monthly Sulfadoxine-Pyrimethamine (SP) During Pregnancy; Monthly Dihydroartemisinin-Piperaquine (DP) During Pregnancy
Intervention MeSH terms: Pyrimethamine; Piperaquine; Sulfadoxine; Fanasil, pyrimethamine drug combination; Artenimol
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 782.0
Sex: Female
Minimum age: 16 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Chemoprevention; Malaria; Sulfadoxine-Pyrimethamine; Dihydroartemisinin-Piperaquine

Summary:

      This will be a double-blinded randomized controlled phase III trial of 782 HIV uninfected
      pregnant women and the children born to them. HIV uninfected women at 12-20 weeks gestation
      will be randomized in equal proportions to one of two intermittent preventive treatment in
      pregnancy (IPTp) treatment arms: 1) monthly sulfadoxine-pyrimethamine (SP), or 2) monthly
      dihydroartemisinin-piperaquine (DP). Both interventions arms will have either SP or DP
      placebo to ensure adequate blinding is achieved in the study. Follow-up for the pregnant
      women will end approximately 6 weeks after giving birth. All children born to mothers
      enrolled in the study will be followed from birth until they reach 12 months of age.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pregnancy confirmed by positive urine pregnancy test or intrauterine pregnancy by
             ultrasound

          -  Estimated gestational age between 12-20 weeks

          -  Confirmed to be HIV uninfected by rapid test

          -  16 years of age or older

          -  Resident of Busia District, Uganda

          -  Provision of informed consent by the pregnant woman for herself and her unborn child

          -  Agreement to come to the study clinic for any febrile episode or other illness and
             avoid medications given outside the study protocol

          -  Plan to deliver in the hospital

        Exclusion Criteria:

          -  History of serious adverse event to SP or DP

          -  Active medical problem requiring inpatient evaluation at the time of screening

          -  Intention of moving outside of Busia District, Uganda

          -  Chronic medical condition requiring frequent medical attention

          -  Prior SP preventive therapy or any other antimalarial therapy during this pregnancy

          -  Early or active labor (documented by cervical change with uterine contractions)
The Safety and Efficacy of Zoledronic Acid in the Prevention of Cancer Therapy Induced Bone Loss
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Zoledronic acid; Placebo
Intervention description: Placebo
Intervention MeSH terms: Zoledronic Acid
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 70.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Breast Cancer; Premenopausal; Bone mineral density; Cancer therapy induced bone loss; zoledronic acid

Summary:

      This study examines the safety and efficacy of zoledronic acid 4 mg., given every 3 months
      over 24 months (infusion at month 0, 3, 6, 9, 12, 15, 18 and 21) in improving bone mineral
      density in premenopausal women with hormone receptor negative breast cancer and adjuvant
      chemotherapeutic treatment
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female patients with histologically confirmed incident invasive breast cancer (T1-4)
             with positive hormone receptor status (ER and/or PgR positive) and no evidence of
             regional lymph node metastasis (N0) or distant metastasis (M0)

          -  Patient has undergone complete primary tumor resection and axillary lymph node
             dissection less than 90 days before start of study drug treatment.

          -  Patient is premenopausal at diagnosis of breast cancer (spontaneous and regular menses
             with premenopausal estradiol levels (>10 ng/dL)

          -  Patient receives adjuvant standard chemoendocrine or endocrine therapy

          -  Bone density at study entry > -2.5 T-Score

        Exclusion Criteria:

          -  History of treatment or disease affecting bone metabolism (e.g., Paget's disease,
             primary hyperparathyroidism), prior treatment with bisphosphonates or treatments for
             osteoporosis in addition to calcium and vitamin D

          -  Abnormal renal function

          -  Current active dental problems including infection of the teeth or jawbone (maxilla or
             mandibular); dental or fixture trauma, or a current or prior diagnosis of
             osteonecrosis of the jaw (ONJ), of exposed bone in the mouth, or of slow healing after
             dental procedures, recent (within 6 weeks) or planned dental or jaw surgery (e.g.
             extraction, implants)

          -  Pregnancy or lactation

          -  Women of childbearing potential not applying a medically recognized form of
             contraception (i.e., oral contraceptives or implants, IUD, vaginal diaphragm or
             sponge, or condom with spermicide)

        Other protocol-defined inclusion/exclusion criteria may apply
OTX-15:003: A Phase 3 Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Ocular Inflammation and Pain After Cataract Surgery
Condition: Post-Surgical Ocular Pain; Post-Surgical Ocular Inflammation
MeSH terms: Cataract; Capsule Opacification; Inflammation
Intervention: Dexamethasone; Placebo Vehicle
Intervention MeSH terms: Dexamethasone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 438.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The objective of the study was to evaluate the safety and efficacy of OTX-DP (dexamethasone
      insert) 0.4 mg for intracanalicular use when placed in the canaliculus of the eyelid for the
      treatment of post-surgical inflammation and pain in subjects who had undergone cataract
      extraction with intraocular lens implantation
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has a cataract and is expected to undergo clear corneal cataract surgery with
             phacoemulsification and implantation of posterior chamber lens

          -  Has a potential post-operative pinhole corrected Snellen VA of at least 20/200 or
             better in both eyes

        Exclusion Criteria:

          -  Any intraocular inflammation in the study eye present during the screening slit lamp
             examination

          -  Score greater than "0" on the Ocular Pain Assessment in the study eye at Screening

          -  Any intraocular inflammation in the study eye present during the screening slit lamp
             examination
Vascular Endothelial Growth Factor (VEGF) Trap-Eye: Investigation of Efficacy and Safety in Central Retinal Vein Occlusion (CRVO)
Condition: Retinal Vein Occlusion
MeSH terms: Retinal Vein Occlusion
Intervention: Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321); Sham treatment
Intervention description: Intravitreal injection. Weeks 0 to 20 of Aflibercept Injection every 4 weeks; Weeks 24 to 52 every 4 weeks PRN (pro re nata, on demand); plus additional on Week 60 and 68.; Sham treatment. Weeks 0 to 52 sham treatment every 4 weeks; plus additional on Week 60 and 68.
Intervention MeSH terms: Aflibercept
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 177.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Macular Edema; Central Retinal Vein Occlusion; CRVO; VEGF Trap-Eye; best-corrected visual acuity

Summary:

      To determine the efficacy of vascular endothelial growth factor (VEGF) Trap-Eye injected into
      the eye on vision function in subjects with macular edema as a consequence of central retinal
      vein occlusion
    

Eligibility criteria:

        Inclusion Criteria:

          -  Center-involved macular edema secondary to central retinal vein occlusion (CRVO) for
             no longer than 9 months with mean central subfield thickness ≥ 250 μm on optical
             coherence tomography (OCT)

          -  Adults ≥ 18 years

          -  Early treatment diabetic retinopathy study (ETDRS) best corrected visual acuity (BCVA)
             of 20/40 to 20/320 (73 to 24 letters) in the study eye

        Exclusion Criteria:

          -  Any prior treatment with anti-VEGF agents in the study eye (Pegaptanib sodium,
             anecortave acetate, bevacizumab, ranibizumab, etc.) or previous administration of
             systemic anti-angiogenic medications

          -  Prior panretinal laser photocoagulation or macular laser photocoagulation in the study
             eye

          -  CRVO disease duration > 9 months from date of diagnosis

          -  Previous use of intraocular corticosteroids in the study eye or use of periocular
             corticosteroids in the study eye within the 3 months prior to Day 1

          -  Iris neovascularization, vitreous hemorrhage, traction retinal detachment, or
             preretinal fibrosis involving the macula in either the study eye or fellow eye
Randomized, Double-blind, Placebo Controlled, Multi-center and Tolerability of RBP-7000 in Schizophrenia Patients
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: RBP-7000; Placebo; Risperidone
Intervention description: RBP-7000 90 mg and 120 mg were a mixture of the ATRIGEL Delivery System and 90 mg and 120 mg risperidone, respectively. The ATRIGEL Delivery System allows for sustained-release of risperidone in a controlled manner. Subcutaneous RBP-7000 injections on Days 1 and 29 in the lower quadrant of the abdomen rotating right and left on day 1 and 29.; Subcutaneous injection of placebo using the ATRIGEL Delivery System on Days 1 and 29 in the lower quadrant of the abdomen rotating right and left on day 1 and 29.; Oral risperidone 0.25 mg tablets daily for the first two days of the screening period. The two 0.25 mg tablets confirmed whether study participants had any negative reaction to risperidone prior to receiving a long-acting injection of risperidone (RBP-7000).
Intervention MeSH terms: Risperidone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 354.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: Schizophrenia; Schizophrenic; Schizophrenias; Risperidone

Summary:

      The purpose of this study is to evaluate the efficacy and safety of RBP-7000 compared with
      placebo in the treatment of patients with schizophrenia.

      This will be a double-blind, placebo-controlled, Phase III study with 90 mg and 120 mg doses
      of RBP-7000 compared with placebo over an 8-week treatment period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and females between the ages of 18 to 55 years, inclusive

          -  Diagnosis of schizophrenia as defined by Diagnostic and Statistical Manual, Edition 4,
             text revision (DSM-IV-TR) criteria

          -  Subjects who are deemed "valid" by the State, Assessability, Face, Ecological, and
             Rule (SAFER) interview

          -  Subjects who are otherwise healthy on the basis of their physical examination

        Exclusion Criteria:

          -  Subjects who have an improvement in their total Positive and Negative Syndrome Scale
             (PANSS) score of 20% or greater between the initial screening visit and the first day
             of treatment.

          -  Subjects taking daily oral risperidone at a dose ≥ 6 mg/day

          -  Subjects who have received a depot antipsychotic within 120 days of screen

          -  Subjects with treatment resistant schizophrenia, as judged by the investigator, who
             have been treated with antipsychotics for adequate durations and with adequate
             dosages.
ALK21-021: A Safety Study of Medisorb® Naltrexone (VIVITROL®) Administered to Health Care Professionals
Condition: Opiate Dependence
MeSH terms: Opioid-Related Disorders
Intervention: Medisorb naltrexone 380 mg
Intervention description: Intramuscular (IM) injection administered once every 4 weeks for up to 2 years
Intervention MeSH terms: Naltrexone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 38.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: opioid dependence; VIVITROL; opioid-related disorders

Summary:

      The purpose of this study is to determine the safety and tolerability of Medisorb® naltrexone
      (VIVITROL®) when administered over a period of 24 months to health care professionals who
      have a history of opioid dependence.
    

Eligibility criteria:

        Primary Inclusion Criteria:

          -  Health care professional (eg, physician, osteopath, nurse, pharmacist)

          -  18 years of age or older

          -  Enrolled or enrolling in an extended outpatient treatment program for opioid
             dependence

          -  Women of childbearing potential must agree to use an approved method of contraception
             for the duration of the study

        Primary Exclusion Criteria:

          -  Pregnancy and/or lactation

          -  Evidence of hepatic failure

          -  Active hepatitis

          -  Any psychiatric disorder that would compromise ability to complete study requirements

          -  Recent history of suicidal ideation or attempt

          -  Current dependence to any drugs other than prescription opioids or heroin,
             benzodiazepines, caffeine, marijuana, alcohol, or nicotine

          -  Positive urine drug test or self-reported use of opioids, cocaine, or amphetamines at
             screening
Montelukast Asthmatic Smoker Study (0476-332)(COMPLETED)
Condition: Asthma
MeSH terms: Asthma
Intervention: montelukast sodium; Comparator: Placebo; Comparator: fluticasone; Comparator: Placebo
Intervention description: montelukast 10 mg tablet once daily, 6 month treatment period; fluticasone propionate 250 mcg Placebo (Pbo) twice daily, 6 month treatment period; fluticasone propionate 250 mcg twice daily, 6 month treatment period; montelukast 10 mg Pbo tablet once daily, 6 month treatment period
Intervention MeSH terms: Fluticasone; Montelukast
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1640.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No

Summary:

      This is a multicenter study to evaluate the efficacy and safety of MK0476 versus placebo in
      participants with chronic asthma who actively smoke cigarettes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants with chronic asthma who actively smoke at least 0.5 to no more than 2
             packs of cigarettes a day

        Exclusion Criteria:

          -  Participant cannot have a diagnosis of Chronic Obstructive Pulmonary Disease (COPD) or
             emphysema.
Evaluation of Vitamin D Requirements During Pregnancy
Condition: Vitamin D Deficiency
MeSH terms: Vitamin D Deficiency
Intervention: cholecalciferol (vitamin D3); cholecalciferol
Intervention description: randomized control trial of three vitamin D doses: 400, 2000 and 4000 IU/day; comparing vitamin D requirements of pregnant women and their fetuses from 12 weeks' gestation through pregnancy
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 501.0
Sex: Female
Minimum age: 16 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: vitamin D; cholecalciferol; pregnancy; bone mineral density

Summary:

      The purpose of this study is to determine the effectiveness of vitamin D supplementation
      during pregnancy starting at the beginning of the second trimester. Mothers will be
      randomized to one of three vitamin D dosing groups: 400, 2,000 or 4,000 international units
      per day. It is hypothesized that the highest dosing regimen will result in a better vitamin D
      status of women regardless of their ethnicity or race.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Women who are within the ages of 16-45 years

          2. In good general health

          3. Less than 12 weeks pregnant (based on last menstrual period)

        Exclusion Criteria:

          1. Mothers with preexisting type I or type II diabetes

          2. Mothers with preexisting hypertension

          3. Mothers with preexisting parathyroid disease or uncontrolled thyroid disease

          4. Mothers with multiple fetuses (e.g., twins, triplets, etc.)
Study of Efficacy and Safety of QAW039 in Patients With Severe Asthma Inadequately Controlled With Standard of Care Asthma Treatment.
Condition: Asthma
MeSH terms: Asthma
Intervention: QAW039; QAW039; Placebo
Intervention description: QAW039 150 mg once daily; QAW039 450 mg once daily; Placebo once daily
Intervention MeSH terms: Indoleacetic Acids
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 894.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Asthma; QAW039; allergic asthma; allergy triggered asthma; reactive asthma; asthma attack; difficulty breathing

Summary:

      This study aimed to determine the efficacy and safety of QAW039 150 mg and QAW039 450 mg,
      compared with placebo, when added to GINA (Global Initiative for Asthma) steps 4 and 5
      standard-of- care (SoC) asthma therapy (GINA 2016) in the following two populations:

        -  patient with inadequately controlled severe asthma and high eosinophil counts at
           baseline (eosinophil count at Visit 1 ≥250 cells/ µl) (sub-population)

        -  patients with inadequately controlled severe asthma (overall study population)

      Inadequate control is defined as partly controlled or uncontrolled asthma (GINA 2016).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent and assent (if applicable).

          -  Male and female patients aged ≥12 years (or ≥lower age limit allowed by health
             authority and/or ethics committee/institutional review board approvals).

          -  A diagnosis of severe asthma, uncontrolled on GINA 4/5 asthma medication.

          -  Evidence of airway reversibility or airway hyper- reactivity.

          -  FEV1 of ≤80% of the predicted normal value for patients aged ≥18 years; FEV1 of ≤90%
             for patients aged 12 to <18 years

          -  An ACQ score ≥1.5.

          -  A history of 2 or more asthma exacerbations within the 12 months prior to entering the
             study.

        Exclusion Criteria:

          -  Use of other investigational drugs within 5 half-lives of study entry, or within 30
             days, whichever is longer.

          -  Subjects who have participated in another trial of QAW039.

          -  A QTcF (Fridericia) ≥450 msec (male) or ≥460 msec (female).

          -  History of malignancy with the exception of local basal cell carcinoma of the skin.

          -  Pregnant or nursing (lactating) women.

          -  Serious co-morbidities.

          -  Patients on greater than 20 mg of simvastatin, greater than 40 mg of atorvastatin,
             greater than 40 mg of pravastatin, or greater than 2 mg of pitavastatin
Suppression Of Atrial Fibrillation With Ranolazine After Cardiac Surgery
Condition: Heart; Dysfunction Postoperative, Cardiac Surgery
MeSH terms: Atrial Fibrillation
Intervention: Ranolazine; Placebo
Intervention description: Ranolazine 1000mg (2-500mg tablets) twice daily. Starting 2 days prior to surgery, morning of surgery and up to 14 days post operative depending when the breathing tube is removed from the patient post operative. If intolerant to the study drug due to adverse effects or the patient is started on diltiazem or verapamil post operative then the dose will be reduced to 500mg (1-500mg tablet) twice daily; Placebo 1000mg (2-500mg tablets) twice daily. Starting 2 days prior to surgery, morning of surgery and up to 14 days post operative depending when the breathing tube is removed from the patient post operative. If intolerant to the study drug due to adverse effects or the patient is started on diltiazem or verapamil post operative then the dose will be reduced to 500mg (1-500mg tablet) twice daily
Intervention MeSH terms: Ranolazine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 15.0
Sex: All
Minimum age: 22 Years
Healthy volunteers: No
Keywords: Suppress Atrial Fibrillation; heart bypass surgery; heart valve surgery

Summary:

      The objective of this study is to show that ranolazine is a safe, viable and potent
      alternative for post-operative atrial fibrillation suppression in patients undergoing cardiac
      surgery
    

Eligibility criteria:

        Inclusion Criteria:

          -  Indications for cardiac surgery (CABG, valve surgery or CABG and valve surgery, Able
             to provide informed consent.

        Exclusion Criteria:

          -  Documented atrial fibrillation within the previous 3 months

          -  Ongoing therapy with suppressive antiarrhythmic drugs

          -  Patient currently on digoxin

          -  Emergent surgery

          -  Patient receiving hemodialysis

          -  Concomitant use of ketoconazole, diltiazem, verapamil

          -  Known tolerance or hypersensitivity to ranolazine

          -  Pregnant individuals

          -  MAZE procedure (is a surgical ablation to treat atrial fibrillation) performed during
             concurrent cardiac surgery