bioihbjkbjnl/mcl2 huggingface dataset:
Tiagabine for the Treatment of Cocaine Dependence - 1
Condition: Cocaine-Related Disorders
MeSH terms: Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess tiagabine for the treatment of cocaine dependence.
    

Detailed description: 
      To assess the efficacy and safety of tiagabine in reducing cocaine use in subjects with
      cocaine dependence. It is hypothesized that tiagabine treatment, compared to placebo, will be
      associated with fewer days of cocaine use as assessed by self-report confirmed with urine
      assays for benzoylecgonine (BE). This is a double-blind, placebo-controlled, parallel-group
      design study, in which, after screening and a 2-week baseline assessment period, subjects
      will be equally randomly assigned to 1 of 2 treatment groups, tiagabine or matched placebo.
    

Intervention name(s): Tiagabine
Intervention type(s): Drug
Intervention MeSH terms: Tiagabine
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: cocaine dependence
Acute Physiological Effects of Electronic Sigarette vs Cigarette Smoking
Condition: Individuality
Study type: Interventional

Summary: 
      Because e-cigarettes do not contain or burn tobacco, they do not appear to deliver the known
      toxins found in conventional cigarette smoke.However e-Cigarettes with low dose of tobacco
      were found to have immediate adverse physiologic effects after short-term use that are
      similar to some of the effects seen with tobacco smoking.

      In this study we wanted to assess the short-time effect of one e-cigarette with no tobacco vs
      a "traditional" cigarette.

      10 n-smoking subject and 10 actual smokers will be enrolled in the randomized trial.
    

Detailed description: 
      On day 1 the subjects will be asked to smoke either the e-cigarette or a "traditional" one
      for 5 minutes. On day 2 the subject will be ask to smoke for 5 minutes the other kind of
      cigarette.

      Exhaled Nitric Oxide will be measured in a sitting position with a nose clip using an
      analyzer equipped with a software program. The patient will be instructed to inhale as deeply
      as possible to total lung capacity through a filter mouthpiece and consecutively exhale at a
      mouth fl ow rate of 50 mL/s for 10 s. Three consecutive trials will be performed with a 30-s
      interval.

      Dynamic Lung Volumes: Flows and lung volumes will be measured in the sitting position, a
      spirometry system (heated pneumotach, with the highest FEV 1 recorded in line with pulmonary
      guidelines. Spirometry will be measured according to the recommendations of the American
      Thoracic Society/European Respiratory Society task force guidelines. FEV 1, FVC, FEV 1 %,
      peak expiratory fl ow (PEF), and maximal expiratory fl ow (MEF) at 25%, 50%, and 75% of vital
      capacity will be measured. Each maneuver will be repeated for at least three technically
      acceptable forced expiratory fl ow curves.
    

Intervention name(s): e-cigarette; cigarette
Intervention type(s): Device; Device
Intervention description(s): smoking cigarette without tobacco; smoking cigarette with tobacco
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Central Corneal Thickness and 24-hour Fluctuation of Intraocular Pressure
Condition: Open Angle Glaucoma; Ocular Hypertension
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether 24-hour fluctuation of intraocular pressure
      (IOP) is associated with central corneal thickness (CCT) in subjects with ocular hypertension
      or open angle glaucoma and in age-matched controls. Also to evaluate whether mean IOP
      reduction as a response to latanoprost (0.005% Xalatan) is associated with CCT, after a
      4-weeks period of treatment.

      Also, to evaluate whether 24-hour fluctuation of IOP is associated with corneal hysteresis
      (CH) measured by Ocular Response Analyzer (ORA).
    


Intervention name(s): Latanoprost
Intervention type(s): Drug
Intervention description(s): 1 eyedrop of latanoprost (0.005%) dosed once a day at 8:00pm for a 4-weeks period
Other intervention name(s): 0.005% Xalatan
Intervention MeSH terms: Latanoprost
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Central corneal thickness; 24hour fluctuation of intraocular pressure; Open angle glaucoma; Ocular hypertension
Effect of Pentoxifylline on Proteinuria in Korean Type 2 Diabetic Patients
Condition: Type 2 Diabetes
MeSH terms: Proteinuria; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      This multi-center, randomized controlled study aims to evaluate the effects of pentoxifylline
      on proteinuria in Korean type 2 diabetic patients.
    

Detailed description: 
      The investigators will recruit adults patients with type 2 diabetes aged over 20 years with
      spot urine albumin to creatinine ratio over 30mg/g in two consecutive measurements.

      Enrolled patients will be randomly assigned to receive pentoxifylline (400mg three times
      daily) or placebo for 24 weeks.

      Fasting blood and spot urine will be collected at baseline, 12 weeks and 24 weeks.

      The investigators will evaluate the impact of pentoxifylline on proteinuria in type 2
      diabetic patients.
    

Intervention name(s): Pentoxifylline; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Pentoxifylline 400mg three times a day; placebo tablet three times a day
Other intervention name(s): Trental
Intervention MeSH terms: Pentoxifylline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Type 2 Diabetes; pentoxifylline; proteinuria
Study on Hydronidone Capsule BE
Condition: Healthy
Study type: Interventional

Summary: 
      The purpose of this study was to compare the hydronidone capsules (specification: 30
      mg/particle, test preparation) developed by Shanghai Ruixing Gene Technology corporation with
      Self reference preparation hydronidone capsule (specification: 15 mg/capsule) Differences in
      the extent and rate of absorption of healthy male subjects in Fasting state in China. Through
      the main pharmacokinetic parameters and relative bioavailability, whether the two are
      bioequivalent, and provide a basis for the registration of the test preparation
    


Intervention name(s): Hydronidone Capsule(Specification: 30 mg / grain）; Hydronidone Capsule(Specification: 15 mg / grain）
Intervention type(s): Drug; Drug
Intervention description(s): Test group; Control group
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Prolonged Grief in Young Bereaved Spouses and Partners
Condition: Grief
Study type: Observational

Summary: 
      The purpose of the research is to learn more about the experience of grief in young bereaved
      spouses/partners. Recent research has shown that young bereaved spouses/partners experience
      grief uniquely from other age groups, but it is still unclear how certain factors affect the
      experience of grief. The investigators research team is interested in studying how the
      psychological factors of trauma, personality, and meaning of the loss affect grief reactions
      in young spouses/partners after the loss of a spouse to cancer.
    


Intervention name(s): in-person or telephone interview
Intervention type(s): Behavioral
Intervention description(s): Participants will be administered one battery of questionnaires that should take 50- 55 minutes, which may be broken down into two or more segments if necessary. They may choose to have these questionnaires administered to them in person at the hospital, in person at their home, or via telephone by a trained master's level research assistant.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Only spouses/partners of deceased Calvary and Memorial Sloan Kettering patients will be
        assessed in this study.
      
Keywords: Young Bereaved Spouses
Naproxen Sodium/Acetaminophen Proof of Concept Dosing Study
Condition: Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      Study assessing efficacy and safety of concomitantly dosed naproxen sodium with
      acetaminophen, compared with naproxen sodium, hydrocodone/acetaminophen and Placebo in a
      postoperative dental pain.
    

Detailed description: 
      This is a randomized, double-blind, placebo- and active-controlled, parallel-group study to
      evaluate the analgesic efficacy and safety of concomitantly administered naproxen sodium 440
      mg with acetaminophen 1000 mg and concomitantly administered naproxen sodium 220 mg with
      acetaminophen 650 mg, compared with a fixed combination of hydrocodone 10 mg/acetaminophen
      650 mg, naproxen sodium 440 mg, and placebo over a twelve-hour period after surgical
      extraction of four third molars.
    

Intervention name(s): 440 mg naproxen sodium with 1000 mg acetaminophen; 220 mg naproxen sodium with 650 mg acetaminophen; 10 mg hydrocodone + 650 mg acetaminophen; 440 mg naproxen sodium; Placebo tablet
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): 440 mg naproxen sodium with 1000 mg acetaminophen administered as a single dose of two naproxen sodium 220 mg tablets and two acetaminophen 500 mg tablets; 220 mg naproxen sodium with 650 mg acetaminophen administered as a single dose of one naproxen sodium 220 mg tablet and two acetaminophen 325 mg tablets and one placebo tablet; 10 mg hydrocodone with 650 mg acetaminophen administered as a single dose of two hydrocodone 5 mg + acetaminophen 325 mg tablets and two placebo tablets; 440 mg naproxen sodium administered as a single dose of two naproxen sodium 220 mg tablets and two placebo tablets; Single dose of four placebo tablets
Other intervention name(s): Naproxen Sodium with Acetaminophen - High Dose; Naproxen Sodium with Acetaminophen - Low Dose; Commercial Hydrocodone + Acetaminophen Tablet; Naproxen sodium
Intervention MeSH terms: Acetaminophen; Naproxen; Acetaminophen, hydrocodone drug combination; Hydrocodone
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Post-operative dental pain following third molar extraction.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Analgesics; Dental Pain; Naproxen; Acetaminophen; Pain
Airway Microbiome in Asthma: Relationships to Asthma Phenotype and Inhaled Corticosteroid Treatment
Condition: Asthma; Atopy
MeSH terms: Asthma
Study type: Interventional

Summary: 
      There are new, very sensitive methods for detecting bacteria. These methods show that
      hundreds of millions of microbes (organisms that can only be seen with microscopes),
      especially bacteria, live in healthy people. The collection of different microbes found in a
      site is called a "microbiome." The investigators know that microbiomes of the skin, sinuses,
      mouth, gastro-intestinal tract, etc. differ from each other. The make-up of the microbiome -
      which bacteria are found in a site - may be necessary for good health. For example, the
      microbiome of the mouth is different in people with inflammation of the gums (periodontitis),
      and the microbiome of the bowel is different in people with inflammation of the intestinal
      tract (inflammatory bowel disease).

      The purpose of this research study is to find out if the microbiome in the lungs is different
      in healthy people without asthma compared to people with asthma. This study will also find
      out if the microbiome of the lungs changes when people with asthma take a daily "controller"
      medication called an inhaled corticosteroid.
    

Detailed description: 
      Two broad specific aims of this study are: 1)To evaluate whether the microbiota of the
      bronchial airways in atopic asthmatics and atopic healthy controls differ in microbial
      diversity, richness, evenness, or composition of specific bacterial taxa. 2) To determine
      whether inhaled corticosteroid treatment alters bronchial microbial community composition in
      asthmatics.
    

Intervention name(s): fluticasone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Dry Powder Inhaler: 250 mcg/puff, one puff, twice a day; Dry Powder Inhaler: Placebo
Other intervention name(s): Flovent 250
Intervention MeSH terms: Fluticasone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
A Clinical Trial to Assess Three Different Doses of OPS-2071 in Patients With Bacterial Enteritis
Condition: Bacterial Enteritis
MeSH terms: Enteritis
Study type: Interventional
Phase: Phase 2

Summary: 
      To assess safety, efficacy and pharmacokinetics of multiple dosesin patients with Bacterial
      Enteritis caused by Clostridium difficile infection(CDI) or Enteric infection.
    


Intervention name(s): OPS-2071 tablet
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Rituximab for Pediatric Renal Transplant Rejection
Condition: Kidney Transplantation
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Rituximab will be tested for its safety and potential efficacy in treating B cell dense renal
      allograft rejection episodes in children receiving renal transplants at Stanford University
    

Detailed description: 
      Twenty kidney transplant recipients who are being cared for at Stanford University and UCLA
      and are between the ages of 2-21, can be considered for participation in this research if
      they are having an acute rejection episode. After a biopsy is done and the diagnosis of acute
      rejection is made, ten patients will be randomly enrolled in the group to be treated with
      Rituximab and steroid pulses. Ten children will be enrolled as the control group, receiving
      standard of care for acute transplant rejection.

      Assignment will be based on a 1:1 randomization scheme. That means two patients will be
      assigned to the group of patients receiving steroid pulsing and 4 doses of Rituximab. The
      third patient would be assigned to the group receiving steroid pulses and adjustment in
      immunosuppression medications which is the standard of care at Stanford University.

      The dose of Rituximab that will be given is 375 mg/m2 and is administered through an IV.
      Additional doses of Rituximab will be administered on a weekly basis. A total of four doses
      will be given.

      If the acute rejection does not resolve by one-week, patients in both groups have the option
      of receiving polyclonal antibody therapy.
    

Intervention name(s): Rituximab for transplant rejection
Intervention type(s): Drug
Intervention MeSH terms: Rituximab
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of Eflornithine on Facial and Forearm Skin
Condition: Hirsutism
MeSH terms: Hirsutism
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate whether regular use of eflornithine 11.5% cream in
      treating women with facial hair will induce skin damage (atrophy) on the face and/or forearms
    


Intervention name(s): Eflornithine hydrochloride
Intervention type(s): Drug
Intervention MeSH terms: Eflornithine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Use of Antibacterial Cement in Infected Dentin
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Interventional

Summary: 
      Dental materials with antibacterial properties can prevent the harmful effects caused by oral
      cariogenic bacteria. This double-blind controlled clinical trial evaluated the performance of
      antibacterial cement for sealing infected dentin in atraumatic restorations of primary
      molars.
    

Detailed description: 
      The study enrolled 45 children (45 teeth) between 5 and 8 years of age, of both genders,
      divided into two groups. In group A (GA; n=22), the cavities were lined with conventional
      glass ionomer cement (Vidrion F®) and in group B (GB; n=23), with antibacterial cement
      (Vidrion F® containing 1% each of metronidazole, ciprofloxacin, and cefaclor). Both groups
      were restored with Ketac Molar Easymix®. Molars with carious lesions on the inner half of
      dentin without clinical or radiographic pulp damage were selected. Patients were evaluated
      clinically (for pain, fistulas, or mobility) and radiographically (area of caries, periapical
      region, and furcation of teeth) after 1, 3, 6, and 12 months.
    

Intervention name(s): Antibacterial cement
Intervention type(s): Other
Intervention description(s): Glass ionomer cement containing 1% each of metronidazole, ciprofloxacin, and cefaclor
Other intervention name(s): Antibacterial cement (Formula & Ação, São Paulo, Brazil)
Intervention MeSH terms: Anti-Bacterial Agents
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Antibacterial agents; Deciduous Teeth; Clinical Trial
Long-term Safety and Tolerability of TRI476 (Oxcarbazepine) in Children With Inadequately Controlled Partial Onset Seizures
Condition: Partial Onset Seizures
MeSH terms: Seizures
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This study is designed to provide long term safety data of TRI476 in children with
      inadequately-controlled partial seizures. This study is conducted in patients who complete
      the core study CTRI476B1301. Blinding is maintained during the transition and dose adjustment
      phase of the extension study. All patients are treated with TRI476 from the dose adjustment
      phase onwards. The purpose of study is to confirm that TRI476 as adjunctive therapy is safe.
    


Intervention name(s): Oxcarbazepine
Intervention type(s): Drug
Intervention MeSH terms: Oxcarbazepine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Seizures; oxcarbazepine; child
Effect Of Ketoconazole On The Pharmacokinetics Of Tasocitinib (CP-690,550) In Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Estimate the effect of oral ketoconazole administration (400 mg once daily over 3 days) on
      the pharmacokinetics (process by which the drug is absorbed, distributed, metabolized, and
      eliminated by the body) of single 10 mg dose of tasocitinib (CP-690,550) in normal healthy
      volunteers.
    


Intervention name(s): Tasocitinib (CP-690,55) plus Ketoconazole
Intervention type(s): Drug
Intervention description(s): Period 1, Day 1: tasocitinib (CP-690,550) as a single oral 10 mg dose given as two 5 mg tablets Period 2, Days 1-2: ketoconazole as a daily single oral 400 mg (dose given as two 200 mg tablets Period 2, Day 3: ketoconazole as a single oral 400 mg dose given as two 200 mg tablets PLUS tasocitinib (CP-690,550) as a single oral 10 mg oral dose given as two 5 mg tablets Period 2, Day 4: No treatment (discharge)
Intervention MeSH terms: Ketoconazole; Tofacitinib
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Drug-Drug Interaction; Healthy Volunteers; Tasocitinib (CP-690; 550); Ketoconazole
Dose Finding Study of Single Dose GHB11L1 in Healthy Adults
Condition: Influenza, Human
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this phase IIa trial is to evaluate the immunogenicity of a single dose of
      GHB11L1 administered by liquid nasal spray for vaccination against influenza A (H1N1) virus.

      This study is also performed to assess safety, tolerability and pharmacokinetics (shedding)
      of a single dose of GHB11L1 administered by liquid nasal spray.
    

Detailed description: 
      GHB11L1 intends to provide a novel vaccination for influenza virus infection. 48 healthy
      volunteers will be included in this phase IIa study investigating three dose levels. 16
      subjects will be randomised at a ratio of 3:1 for GHB11L1 or placebo.

      Healthy male volunteers, 18-50 years of age and seronegative with respect to the applied
      virus antigens (antibody titers <1:10 detected) will be randomised.

      GHB11L1 will be administered once on day 1. Follow-up visits will be performed on days 2, 8
      and 29.
    

Intervention name(s): GHB11L1; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): GHB11L1 administration by liquid nasal spray at doses of 6.0 log10, 6.5 log10 and 7.0 log10 TCID50/volunteer; SPGN buffer
Other intervention name(s): A/Brisbane/59/07(H1N1)-like delNS1 virus reassortant; SPGN buffer
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: live attenuated flu vaccines; Influenza A (H1N1); intranasal application; replication-deficient influenza virus