bioihbjkbjnl/mcl2 huggingface dataset:
Single Dose Crossover Study of Patient Preference for Unscented Nasonex® Nasal Spray Versus Scented Flonase® Nasal Spray (Study P04208)
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional
Phase: Phase 4

Summary: 
      This was a one-day single dose trial conducted to compare patient's preference for Nasonex®
      (mometasone) versus Flonase® nasal spray. Each patient was randomized to take one dose (2
      sprays in each nostril) of Nasonex or Flonase. Thirty minutes later, each patient was to take
      one dose of the opposite medication. Questionnaires were given to each patient after each
      drug dose to evaluate patient product preference.
    


Intervention name(s): Mometasone Furoate Nasal Spray; fluticasone nasal spray
Intervention type(s): Drug; Drug
Intervention description(s): One dose (2 sprays in each nostril) of Mometasone Furoate Nasal Spray; One dose (2 sprays in each nostril) of fluticasone nasal spray
Other intervention name(s): Nasonex, SCH 032088; Flonase®
Intervention MeSH terms: Fluticasone; Mometasone Furoate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Fibrin Sealant Spray Versus Mechanical Stapling in Laparoscopic Totally Extraperitoneal Hernioplasty
Condition: Hernia
MeSH terms: Hernia
Study type: Interventional
Phase: Phase 3

Summary: 
      Laparoscopic totally extraperitoneal hernioplasty (TEP) is one of the treatment options for
      the repair of primary unilateral inguinal hernia. Previous studies showed that patients
      underwent TEP have less post-operative pain and earlier return to normal activities. However,
      chronic pain is still a major issue affecting quality of life after TEP with a reported
      incidence of 9.2-22.5%. Mechanical stapling is the most commonly used method of mesh fixation
      to prevent mesh migration but nerve entrapment by staples causing intractable pain had been
      reported. Recently several clinical trials showed that mesh fixation with fibrin sealant (FS)
      in TEP resulted in less chronic pain but increased incidence of seroma. A spraying device for
      application of FS laparoscopically is now available which can achieve mesh fixation by using
      fewer amounts of FS.

      In this study, the investigators aim to compare the effectiveness of using fibrin spray for
      mesh fixation in reducing chronic pain after TEP. The investigators performed a randomized
      controlled trial by allocating patients in two study arm in random manner. The treatment
      group will have the mesh fixed by fibrin sealant spray, whereas the control group will have
      conventional mechanical staples for fixation. Operative procedures and post-operative
      management for the 2 groups will be identical. They will be follow-up at 1-month and 6-month
      after operation to evaluate the operative results and the incidence of chronic pain. Any
      complications related to the mesh and operation will also be recorded.
    


Intervention name(s): Fibrin sealant spray; Mechanical stapling
Intervention type(s): Device; Device
Intervention description(s): Fixation of mesh would be performed using fibrin sealant spray applied with a laparoscopic spray catheter; Fixation of mesh would be performed using mechanical staplers
Intervention MeSH terms: Fibrin Tissue Adhesive
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JNJ-39439335 in Patients With Osteoarthritis
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety of multiple oral doses of JNJ-39439335
      and to assess how JNJ-39439335 is absorbed (taken in), distributed, metabolized (broken
      down), and eliminated from the body (referred to as pharmacokinetics) in osteoarthritis
      patients. This study will also assess the effectiveness of JNJ-39439335 on pain.
    

Detailed description: 
      This will be a double-blind (patient and study staff will not know the identity of assigned
      treatment), randomized (assignment to 1 to 3 treatment groups will be by chance, like
      "flipping a coin"), placebo-controlled, multiple dose study conducted at up to two clinical
      sites. Up to 42 patients with osteoarthritis of the knee will be enrolled in 3 cohorts
      (Cohort 1 to 3). Additional cohorts (up to 14 patients per cohort) may be added after
      completion of Cohort 3. The study consists of eligibility screening, a treatment phase, and 4
      follow-up visits. The study duration for each patient will be approximately 10 weeks.
      Patients safety will be closely monitored during the study by review of adverse events,
      electrocardiograms, vital signs (including oral temperature), clinical laboratory tests, and
      physical examinations. During specified study visits, blood samples will be collected for
      pharmacokinetics, pharmacodynamics (inpatient patients), and pharmacogenomic (optional)
      evaluations of JNJ-39439335. The effectiveness of JNJ-39439335 will be evaluated by assessing
      pain using an 11-point numerical rating scale and by the Western Ontario and McMaster
      Osteoarthritis Index. In Cohort 1 and 2, all patients will take their study medication
      orally, twice a day for 21 days. The treatment groups for Cohort 1 are JNJ-39439335 10 mg,
      naproxen 500 mg every 12 hours, and placebo. The treatment groups for Cohort 2 are
      JNJ-39439335 25 mg, naproxen 500 mg every 12 hours, and placebo. The treatment groups for
      Cohort 3 will be determined based on the results of Cohort 1 and 2.
    

Intervention name(s): Placebo; JNJ-39439335; Naproxen; JNJ-39439335
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Placebo tablet/capsule every 12 hours for 21 days; 2 x 25 mg tablets once daily for 21 days; 500 mg capsule every 12 hours for 21 days; 2 x 5 mg tablets once daily for 21 days
Intervention MeSH terms: Naproxen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Osteoarthritis, knee; knee pain; pain measurement
Evaluation of the Hypoallergenicity of a New Formula Based on Hydrolyzed Rice Proteins
Condition: Cow Milk Allergy
MeSH terms: Hypersensitivity; Milk Hypersensitivity
Study type: Interventional

Summary: 
      The aim of this study is to show the hypoallergenicity of a new thickened rice based formula
      (TRHF) through a double blind placebo controlled food challenge (DBPCFC), as recommended by
      the American Academy of Pediatrics, in subjects with IgE-mediated CMA and in subjects with
      non-IgE-mediated CMA.
    

Detailed description: 
      The study is made of 2 different steps : 1st step is a double blind randomised food challenge
      where the new formula is compared to a placebo.

      The second part of the trial consists in an open phase during which all infants will be fed
      with the study formula.
    

Intervention name(s): rice formula; placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): new rice based thickened formula; formula previously tolerated by the subject - only for the 1st part of the study
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Platelet Drug Trial in Coronary Disease Progression
Condition: Cardiovascular Diseases; Coronary Disease; Heart Diseases; Myocardial Ischemia
MeSH terms: Cardiovascular Diseases; Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia; Ischemia
Study type: Interventional
Phase: Phase 3

Summary: 
      To determine the effectiveness of the platelet inhibitor drugs dipyridamole and aspirin in
      reducing the angiographic progression of coronary artery disease over a five-year period and
      to test the predictive value of the platelet survival half-life in identifying patients with
      more rapid progression of coronary disease and development of its complications.
    

Detailed description: 
      BACKGROUND:

      Coronary atherosclerosis is the leading cause of death in this country and the developed
      countries of the world. Although modern coronary care units have resulted in a markedly
      decreased hospital mortality from acute myocardial infarction, especially in those patients
      who enter the hospital early, its overall impact is limited since two-thirds of patients who
      die from coronary disease do not reach the hospital. When the trial was initiated in 1979,
      new approaches to the medical treatment of coronary disease and its complications were needed
      with an effort directed towards prevention of its progression and prevention of its
      complications through medical therapy. This prevention could save significant health care
      dollars over the long-term especially if the need for aortocoronary bypass graft surgery and
      the incidence of myocardial infarction could be reduced. Early identification of the patient
      at risk of developing coronary disease or of those with early coronary artery lesions would
      allow a greater impact of any successful intervention therapy.

      DESIGN NARRATIVE:

      Randomized, double-blind. The patients in the experimental group were treated with
      dipyridamole and aspirin for five years. Patients in the control group received a lactose
      placebo. The primary endpoint was angiographic evidence of progression of coronary artery
      disease and development of new coronary disease. Secondary endpoints included total
      mortality, cardiac mortality, mortality due to myocardial infarction, and incidence of new
      myocardial infarction. Recruitment ended in December 1982.

      The study completion date listed in this record was obtained from the statement immediately
      above ("Recruitment ended in December 1982") and was confirmed from the Query/View/Report
      (QVR) System.
    

Intervention name(s): aspirin; dipyridamole
Intervention type(s): Drug; Drug
Intervention MeSH terms: Aspirin; Dipyridamole
Allocation: Randomized
Masking: Double
Primary purpose: Prevention
Effect of an Apple Polyphenol Extract on Brachial Artery Flow-mediated Vasodilatory Function
Condition: Borderline Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 2

Summary: 
      Effect of apple polyphenols on FMD.
    

Detailed description: 
      The aim of this single centre, repeated-dose, double-blind, placebo-controlled, crossover
      study is to test the hypothesis that an orally ingested apple polyphenol extract rich in
      epicatechin and flavan-3-ol oligomers improves brachial artery endothelium-dependent
      vasodilation function (FMD) in volunteer subjects with borderline hypertension. FMD and
      endothelium-independent nitrate-mediated vasodilatation (NMD) of the left brachial artery
      will be investigated with ultrasonography at the start and end of both treatment periods.
      Biomarkers of vascular function and epicatechin (and metabolite) concentrations will be
      determined from blood samples taken at the start and end of both treatment periods. Diet
      diary data will be collected for the evaluation of the possible effects of diet on the study
      results. Adverse events data will be collected throughout the study. Safety laboratory
      determinations will be performed at the last visit of both treatment periods.
    

Intervention name(s): Epicatechin; Microcrystalline cellulose
Intervention type(s): Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: FMD; epicatechin; apple polyphenol; borderline hypertension
Observational Follow-up of Participants From Clinical Trial 64,185-202 (NCT00850993)
Condition: Jaundice; Neonatal Hyperbilirubinemia
MeSH terms: Hyperbilirubinemia, Neonatal; Jaundice; Hyperbilirubinemia
Study type: Observational

Summary: 
      Observational follow-up of participants from earlier interventional trial 64,185-202
      (NCT00850993).

      No interventions were administered during this follow-up study.
    


Intervention name(s): Stannsoporfin; Placebo Control; Phototherapy (as needed)
Intervention type(s): Drug; Drug; Other
Intervention description(s): No intervention was administered during this observational study; No intervention was administered during this observational study; No intervention was administered during this observational study
Other intervention name(s): Experimental product; Saline; Standard Care
Intervention MeSH terms: Tin mesoporphyrin
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Babies who participated in protocol 64,185-202 (NCT00850993)
      
Keywords: stannsoporfin; hyperbilirubinemia; heme oxygenase
Pharmacokinetics and Safety Study of Tipranavir in Combination With Low Dose Ritonavir in Human Immunodeficiency Virus (HIV)-Infected Children
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to assess the safety and tolerability of tipranavir
      (TPV) oral formulation and soft gelatin capsules together with low-dose ritonavir in
      HIV-infected children and adolescents, to provide information concerning the pharmacokinetic
      characteristics of tipranavir and ritonavir in this age group, and to determine the relative
      bioavailability of the TPV liquid formulation and TPV capsule formulation in adolescents
      switching from liquid to capsule.

      The secondary objective of this study is the determination of the dose of topranavir and
      ritonavir (TPV/r) in children and adolescents between 2 and 18 years of age required for an
      adult equivalent systemic exposure of TPV/r 500 mg / 200 mg.
    


Intervention name(s): TPV oral solution; TPV oral solution; RTV oral solution; RTV oral solution
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Tipranavir oral solution; Tipranavir oral solution; Ritonavir oral solution; Ritonavir oral solution
Intervention MeSH terms: Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effectiveness of Orally Dosed Emergency Contraception in Obese Women - UPA
Condition: Obesity; Contraception
MeSH terms: Emergencies
Study type: Interventional
Phase: Phase 4

Summary: 
      Obese women are significantly more likely than their normal BMI counterparts to experience
      failure of orally-dosed emergency contraceptives. Our preliminary data provides evidence for
      testing a dose escalation strategy in an effort to provide improved efficacy from
      orally-dosed emergency contraceptives in obese women. More data is needed regarding emergency
      contraception containing ulipristal acetate. The overall project will be focused on both
      levonorgestrel (LNG) - and ulipristal acetate (UPA)-containing emergency contraception but
      this protocol registration is for the UPA aspect of the study procedures.
    

Detailed description: 
      Emergency contraception (EC) provides a woman with an additional line of defense against
      unintended pregnancy following an act of unprotected intercourse. Orally-dosed EC works by
      delaying ovulation and reduces the risk of pregnancy for a single act of unprotected
      intercourse by 50-70%. Unfortunately, obese women are significantly more likely than their
      normal BMI counterparts to experience failure of orally-dosed EC and in some instances EC is
      equivalent to placebo.

      Our preliminary data provides evidence for testing a dose escalation strategy in an effort to
      provide improved efficacy from orally-dosed EC in obese women. We hypothesize that increasing
      the dose of orally-dosed EC agents will normalize the pharmacokinetics resulting in the
      expected treatment effect (delay in follicle rupture) in obese women. In the overall
      proposal, we plan to perform detailed pharmacokinetic and pharmacodynamic studies of
      UPA-based EC in obese women and expand upon our preliminary findings of LNG-based EC. This
      protocol registration is for the UPA aspect of the study procedures focused on the
      pharmacokinetics and pharmacodynamics of UPA and will include a dose escalation intervention.
    

Intervention name(s): UPA-ECx1; UPA-ECx2
Intervention type(s): Drug; Drug
Intervention description(s): Evaluating the pharmacodynamic and pharmacokinetic outcomes in obese women using 30mg of UPA-based EC; Evaluating the pharmacodynamic and pharmacokinetic outcomes in obese women using 60mg of UPA-based EC
Other intervention name(s): Ella; Ella-One; ella; ella-one
Intervention MeSH terms: Ulipristal acetate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: obesity; body weight; BMI; emergency contraception; levonorgestrel; ulipristal acetate
A Study to Assess the Effect of Capivasertib on Midazolam in Patients With Advanced Solid Tumours
Condition: Solid Tumour
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, fixed-sequence study to evaluate the effect of capivasertib on the
      pharmacokinetics (PK) of midazolam, a sensitive CYP3A substrate. The PK of midazolam will be
      assessed when administered alone and in combination with repeated doses of capivasertib.
    

Detailed description: 
      This is 2 part study: Part A and Part B. Part A of the study consists of a screening period
      and 3 treatment periods (midazolam alone, capivasertib alone, and midazolam + capivasertib).
      During Part A, the PK profile of midazolam will be determined with and without
      capivasertib.All participants will receive capivasertib treatment (4 days on/3 days off);
      however, at the Investigator's discretion, ER positive breast cancer patients may also
      receive fulvestrant in addition to capivasertib and midazolam. Participants completing Part A
      without disease progression or unacceptable toxicity, who are considered likely to continue
      to benefit from further capivasertib treatment (with or without certain standard of care
      treatment) in the opinion of the Investigator will enter Part B. Part B of the study consists
      of an extended treatment period with capivasertib, with or without certain standard of care
      treatment, followed by a 30-day safety follow-up.

      Part A of the study may be extended to allow the administration of midazolam on a rescheduled
      Cycle 1 Day 8(C1D8) and Cycle 1 Day 12(C1D12 ) visit.
    

Intervention name(s): Capivasertib; Midazolam
Intervention type(s): Drug; Drug
Intervention description(s): Capivasertib (tablet) will be given as an intermittent schedule (4 days on/3 days off) from Cycle 1 Day 2 until discontinuation. Capivasertib will be administrated in both Part A and Part B.; Single doses of midazolam (syrup, 1 mg) will be given on cycle 1 Days 1, 8, and 12.
Intervention MeSH terms: Midazolam
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: CYP3A inhibitor; Pharmacokinetics; Safety
A Study to Assess the Bioequivalence of Darunavir When Co-Administrated With Cobicistat Under Fed and Fasted Conditions
Condition: Healthy Participants
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the single-dose pharmacokinetics and bioequivalence
      of darunavir 800 mg when administered as a fixed dose combination relative to 2 x 400 mg
      tablets of the commercial tablet formulation, in the presence of 150 mg cobicistat, (under
      fed and fasted conditions) in healthy participants.
    

Detailed description: 
      This is a randomized (the study drug is assigned by chance), open-label (all people know the
      identity of the intervention), 3-panel, single-center, single-dose, crossover (method used to
      switch patients from one treatment arm to another in a clinical trial) study in 134 healthy
      adult participants. The study consists of 3 phases including a screening phase of
      approximately 3 weeks (Days -21 to -1) followed by an open-label treatment phase consisting
      of 3 panels with 2 single-dose treatment sessions of 5 days each (Days -1 to 4) separated by
      a washout period of at least 7 days, and a follow-up period occurring 7 to 10 days after last
      intake of study drugs. The study consists of 3 panels. In each panel participants will be
      randomly be assigned to 1 of 2 treatment sequences (AB or BA for Panel 1; CD or DC for Panel
      2; and EF or FE for Panel 3). Participants will receive either single-dose darunavir 800 mg
      as 2 x 400 mg tablets and cobicistat 150 mg tablet or single-dose darunavir/cobicistat
      800/150 mg as tablet in each panel (under fed and fasted conditions).
    

Intervention name(s): darunavir; cobicistat
Intervention type(s): Drug; Drug
Intervention description(s): Type=exact number, unit=mg, number=400, form=tablet, route=oral. Two tablets as a single dose or a tablet in combination with cobicistat; Type=exact number, unit=mg, number=150, form=tablet, route=oral. One tablet as a single dose or a tablet in combination with darunavir
Intervention MeSH terms: Darunavir; Cobicistat
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy participants; Darunavir; Cobicistat; Bioequivalence; Fixed dose combination; Pharmacokinetics; Human immunodeficiency virus; Protease inhibitor
Surgical Management of Optic Disc Pit Maculaopathy
Condition: Optic Disc Structural Anomaly; Maculopathy
MeSH terms: Macular Degeneration
Study type: Interventional

Summary: 
      To evaluate the anatomical and functional results of pars plana vitrectomy (PPV) combined
      with internal limiting membrane (ILM) peeling, endolaser photocoagulation and gas tamponade
      in management of optic disc pit (ODP) maculopathy.
    

Detailed description: 
      As it is well known, optic disc pit (ODP) is a rare congenital disease which is usually
      associated with maculopathy (ODP-M) in the form of intraretinal and subretinal fluid
      accumulation at the macular area leading to visual impairment.

      With no definite treatment and absence of guidelines for its management, the invistigators
      considered their prospective, interventional case series to evaluate the anatomical and
      functional results of pars plana vitrectomy (PPV) combined with internal limiting membrane
      (ILM) peeling, endolaser photocoagulation and gas tamponade in management of optic disc pit
      (ODP) maculopathy.
    

Intervention name(s): pars plana vitrectomy with internal limiting membrane (ILM) peeling
Intervention type(s): Procedure
Intervention description(s): pars plana vitrectomy (PPV) combined with internal limiting membrane (ILM) peeling, endolaser photocoagulation and gas tamponade in management of optic disc pit (ODP) maculopathy.
Other intervention name(s): Endolaser photocoagulation
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: optic disc pit; retinal detachment; maculopathy