bioihbjkbjnl/mcl2 huggingface dataset:
Platelet Reactivity Inhibition Following Ticagrelor Loading Dose and One Year Outcome
Condition: Acute Coronary Syndrome
MeSH terms: Acute Coronary Syndrome; Syndrome
Study type: Interventional

Summary: 
      This study will try to determine if the measure of the platelet reactivity of the patients
      receiving from the ticagrelor continuation in an acute coronary syndrome handled by coronary
      angioplasty allows to predict the hemorrhagic risk.
    

Detailed description: 
      The use of thienopyridines in patients undergoing percutaneous coronary intervention (PCI)
      has dramatically decreased the rate of early stent thrombosis. Further the CURE trial
      demonstrated that long-term clopidogrel decreases the rate of major adverse cardiovascular
      events in acute coronary syndrome patients (ACS) . However clopidogrel has several
      limitations including a long delay of action which is a potential limitation in acute
      settings of coronary artery disease. Another major limitation of the drug is the wide inter
      individual variability in clopidogrel responsiveness related to various factors.

      In addition recent studies suggested that platelet reactivity inhibition does also determine
      the bleeding risk.

      The ticagrelor is a new blocker of the receiver P2Y12 which distinguishes itself from the
      clopidogrel by a superior biological efficiency. This biological property was translated in
      the study PLATO, having compared it with the clopidogrel in the ACS, by a reduction of the
      risk thrombotique. The ticagrelor is thus recommended in first intention in this indication.
      There seems be a variability of answer to the ticagrelor. Besides the ticagrelor infers a
      level of intense platelet inhibition which could explain on hemorrhagic risk which is
      associated with it.
    

Intervention name(s): blood sample
Intervention type(s): Other
Intervention description(s): Biological samples will be done to determine platelet reactivity testing by VASP-index, will be obtained between 6 and 12 hours after receiving ticagrelor
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Open-label, Follow-up Study of Oral Testosterone Undecanoate in Hypogonadal Men
Condition: Male Hypogonadism
MeSH terms: Hypogonadism
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this one year extension (follow-up) study is to gather additional safety data
      in hypogonadal men treated with oral TU or AndroGel who have completed the 12-month Phase III
      study CLAR-09007.
    

Detailed description: 
      This is the long-term extension of Study CLAR-09007, which like Study CLAR-09007, is an
      open-label study. This study contained an arm to evaluate the oral TU formulation as well as
      a comparator arm of the market-leading transdermal T-gel formulation. The comparator arm was
      included in the Phase III study and in this extension study to allow a general evaluation of
      comparative safety. Subjects randomized to oral TU in the Phase III study were continued on
      oral TU in the extension, and those who completed this 12-month Phase IV study have been
      followed for a total of 2 years of oral TU therapy. Likewise, subjects randomized to
      transdermal T-gel in the Phase III study were continued on T-gel in the extension, and those
      who completed this 12-month Phase IV study have been followed for a total of 2 years of T gel
      therapy. This 2-year period of therapy and assessments was to provide a long-term view of the
      safety of oral TU and the stability of the T replacement.
    

Intervention name(s): Oral testosterone undecanoate; Transdermal testosterone gel (AndroGel)
Intervention type(s): Drug; Drug
Intervention description(s): Total daily dose of T = 200 mg T (as 316 mg TU) to 600 mg T (as 948 mg TU), taken as 100 mg to 300 mg T BID; Total daily dose of T = 2.5 to 10 g of gel (25 mg to 100 mg T) QD
Other intervention name(s): Oral TU; AndroGel
Intervention MeSH terms: Methyltestosterone; Testosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Varenicline in Bipolar Depressed Patients
Condition: Smoking; Bipolar Disorder; Depression
MeSH terms: Depression; Bipolar Disorder
Study type: Interventional

Summary: 
      Patients with bipolar disorder have one of the highest rates of nicotine dependence and one
      of the lowest quit rates. Varenicline has been shown in previous trials to be effective for
      smoking cessation, but has not been studied in subjects with bipolar disorder. This 12-week
      open label trial will be conducted to assess the feasibility, acceptability, and safety of
      varenicline in bipolar depressed smokers, given in addition to the subject's primary
      treatment for bipolar disorder. The primary study hypothesis was that the abstinence rate for
      bipolar depressed patients will be 50%.
    

Detailed description: 
      Varenicline, a nicotinic acetylcholine receptor partial agonist, has been shown in two
      placebo-controlled trials to be efficacious for smoking cessation. Given the high prevalence
      of nicotine dependence in bipolar disorder and the high prevalence of sub-syndromal and
      syndromal depressive symptoms in bipolar disorder, this 12-week adjunctive varenicline open
      label trial will be conducted to assess the feasibility, acceptability, and safety of
      varenicline in bipolar depressed smokers. All subjects will receive individual behavioral
      counseling.

      Primary hypothesis: the abstinence rate for bipolar depressed patients will be 50%. Secondary
      hypothesis: At final visit, bipolar depressed patients who have achieved remission, defined
      as a Montgomery Asberg Depression Rating Scale (MADRS) <8, will have a higher rate of tobacco
      abstinence than depressed patients who did not achieve remission (MADRS >/= 8).
    

Intervention name(s): Varenicline
Intervention type(s): Drug
Intervention description(s): Varenicline (Chantix®, Pfizer) is an oral medication with a recommended dosage of 0.5 mg once daily for 3 days, increasing to 0.5 mg twice daily for days 4-7, and then to the maintenance dose of 1 mg twice daily for the 12 weeks of treatment.
Other intervention name(s): Chantix
Intervention MeSH terms: Varenicline
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Smoking; Bipolar Disorder; Depression
A Phase 1 Absolute Bioavailability Study For Oral Crizotinib In Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will be an open-label, randomized, 2-period, 2-treatment, 2-sequence, cross-over
      single-dose study to test the absolute bioavailability of oral crizotinib formulation to IV
      formulation in healthy adult volunteers. Fourteen (14) subjects will be enrolled to obtain at
      least 12 evaluable subjects who complete the study. Each subject will receive two treatments
      (A and B) with a washout period of at least 14 days between each treatment.
    

Detailed description: 
      evaluate the absolute bioavailability of oral crizotinib to IV crizotinib.
    

Intervention name(s): crizotinib; crizotinib
Intervention type(s): Drug; Drug
Intervention description(s): Treatment A: Intravenous dose of 50 mg crizotinib will be administered as directed.; Treatment B: Oral dose of 250 mg crizotinib as 1 × 50-mg Immediate Release Tablet and 2 × 100-mg Immediate Release Tablets will be administered in the fasted state as directed.
Intervention MeSH terms: Crizotinib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: healthy volunteers; crizotinib; absolute bioavailability; pharmacokinetics
PECO Air Purification in Hospital Rooms to Improve Health Outcomes for Pediatric Respiratory Distress
Condition: Asthma; Pneumonia; Respiratory Distress Syndrome
MeSH terms: Pneumonia; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn
Study type: Interventional

Summary: 
      This study will investigate the efficacy of a novel air purification technology, Photo
      Electrochemical Oxidation (PECO), has on pediatric patients hospitalized for respiratory
      distress. The study will take place at Mercyhealth Hospital - Rockton Avenue where all 23
      pediatric rooms will be outfitted with portable PECO air purifying units. The main outcomes
      are the length of stay and progression to ICU, which will be compared with historical
      controls.
    

Detailed description: 
      The goal of this study is to assess whether using PECO to purify air in a hospital can
      improve health outcomes for pediatric patients with respiratory distress.

      The results of this study will be used in three primary ways:

        1. As evidence to support an installation of PECO in hospital HVAC systems to improve the
           standard of care for patients with respiratory distress

        2. Towards dissemination efforts through publication in a peer-reviewed journal and
           presentation at national and international conferences

        3. For informing healthcare providers and stakeholders

      There are no plans to repeat this study with other hospital partners
    

Intervention name(s): Photo Electrochemical Oxidation (PECO) for Air Purification
Intervention type(s): Device
Intervention description(s): PECO air purifiers from Molekule will be placed in every patient room. Health metrics will be tracked for patients whose diagnosis is respiratory distress.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: asthma; environmental intervention; respiratory distress; pediatric hospitalization; pneumonia; bronchiolitis
Exercise and Treatment-as-usual in Substance Use Treatment Outcomes
Condition: Substance-Related Disorders
MeSH terms: Substance-Related Disorders
Study type: Interventional

Summary: 
      The research study compares the substance abuse treatment outcomes (e.g., craving, withdrawal
      symptoms, rates of use, abstinence) of standard intensive outpatient care, with or without an
      added 6-wk aerobic exercise component. In addition, certain biomarkers associated with both
      exercise and substance use (e.g., endocannabinoids and cortisol) will be assessed. In a
      rolling admissions format over the course of a year, approximately 36 treatment-seeking
      substance users who are currently receiving Intensive Outpatient Treatment through a local
      Alcohol or Other Drug Abuse agency will be randomized to either receive 6 weeks aerobic
      exercise training in addition to standard care or standard care with 6 weekly laboratory
      visits to complete questionnaires (18 per group).
    


Intervention name(s): exercise; treatment-as-usual
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The EX participants will engage in supervised, individual treadmill exercise 3xs/wk at the UW Natatorium. Sessions will consist of a 5-minute warm-up followed by 30 minutes of a moderate to moderately-high intensity exercise and then finish with a 5-minute cool down. Questionnaires will be completed before and after exercise on a weekly basis.; The control (standard care) participants will come to the UW-Natatorium on a weekly basis to complete questionnaires.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Single-blind, Dose-ranging Study of Novel Swine Influenza Virus Vaccine in Japanese Pediatric Subjects
Condition: Swine-Origin Influenza A H1N1 Virus
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This study is to identify the preferred vaccine dosage (of antigen and adjuvant) and schedule
      (one or two administrations) of the cell-derived H1N1sw monovalent vaccine in healthy
      children/adolescents based on European Medicines Agency's Committee for Medicinal Products
      for Human Use (EMEA/CHMP) criteria, and safety and tolerability.
    

Detailed description: 
      This is a multi-center, randomized, single-blind, dose-ranging study. Subjects were
      randomized at a 1:1 ratio to receive either 3.75μg of cell-derived H1N1sw vaccine formulated
      in half (i.e., half the content of the European-licensed adjuvanted seasonal influenza
      vaccine) MF59 adjuvant (3.75_halfMF59) or 7.5μg of cell-derived H1N1sw vaccine formulated
      with full MF59 (7.5_fullMF59). Subjects were not informed of their allocated doses. Two
      vaccinations were administered IM three weeks apart. Subjects in both the vaccine groups were
      stratified into three age strata: 6 to 35 months, 3 to 8 years and 9 to 19 years. Blood
      samples were collected at day 1 (baseline), three weeks after the first vaccination (day 22)
      and three weeks after the second vaccination (day 43). Sera were tested by Hemagglutination
      Inhibition (HI) and Microneutralization (MN) assays. Local and systemic reactions were
      collected for the first week following each injection using Diary Card (i.e., day 1 to day 7
      and day 22 to day 28). All adverse events (AE), serious adverse events (SAE), and AEs that
      led to withdrawal from the study and related prescription medications were collected for the
      entire study period.
    

Intervention name(s): Adjuvanted cell-derived, inactivated novel swine origin A/H1N1 monovalent subunit influenza virus vaccine
Intervention type(s): Biological
Intervention description(s): High dose group and low dose group of adjuvanted vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Influenza A; H1N1 subtype; Children/adolescent; Vaccine; Adjuvant
An Interactive Game for HIV Prevention in Early Adolescents
Condition: HIV; Risk Reduction
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate, through a randomized clinical trial, the efficacy
      of an interactive video game the investigators are developing at reducing risk behaviors in
      at-risk teens.
    

Detailed description: 
      The purpose of this study is to evaluate, through a randomized clinical trial, the efficacy
      of an interactive video game the investigators are developing at reducing risk behaviors in
      at-risk teens. The investigators are using proven components of HIV prevention interventions,
      social cognitive theory, self-efficacy, prospect theory, message framing, and video gaming
      principles to develop and evaluate this interactive HIV prevention video game. In Phase 1 of
      this project, the investigators have been working with Schell Games of Pittsburgh, PA,
      Digitalmill of Portland, ME, and the Farnam Neighborhood House in New Haven, CT to develop
      our interactive video game with the input from our experts and focus groups and interviews
      with adolescents. Phase 1 has been a developmental iterative process in which the
      investigators have been building the software for the game for the purposes of targeting HIV
      prevention in our population of interest: young minority adolescents. Following development
      of the video game, the investigators will move to Phase 2 in which the investigators will
      enroll 330 minority adolescents who are attendees at one of several after-school programs in
      the greater New Haven area and assign them to play either the experimental game or a control
      game. In the experimental game, the player will be presented with a series of "risk
      challenges" thereby helping them to develop sex, drug and alcohol negotiation and refusal
      skills.
    

Intervention name(s): Experimental Video Game; Off the Shelf Video Game
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants will play either the experimental or the control videogame for 6 weeks. Both interventions will be provided during 12 sessions, twice weekly for 6 weeks; each session will involve one and one-quarter hour of game play.; Participants will play either the experimental or the control videogame for 6 weeks. Both interventions will be provided during 12 sessions, twice weekly for 6 weeks; each session will involve one and one-quarter hour of game play.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Adolescent; risk; HIV; video games
Clopidogrel Reloading in Clopidogrel Resistant Patients With ACS
Condition: Clopidogrel Non-Responsiveness
Study type: Interventional
Phase: Phase 3

Summary: 
      Laboratory clopidogrel resistance is associated with adverse atherothrombotic events in
      patients with coronary artery disease. In the proposed study we wish to prospectively assess
      the effect of reloading with 600 mg clopidogrel, and administer maintenance treatment with
      clopidogrel 150 mg/day for one month in a group of acute myocardial infarction (AMI) patients
      who demonstrate non-responsiveness to clopidogrel.
    

Detailed description: 
      Prior studies have demonstrated significant variability in platelet response to clopidogrel
      in patients with coronary artery disease (CAD). Up to 25% of patients have been shown to be
      non-responders to a conventional dose of clopidogrel. This phenomenon has been associated
      with higher incidence of recurrent cardiovascular (CVS) adverse events in patients with acute
      coronary syndrome (ACS), and higher incidence of peri-procedural myocardial damage,
      thrombotic complications, and ischemic events in patients undergoing elective percutaneous
      coronary intervention (PCI). Both the ex-vivo anti-platelet effect and the clinical benefit
      of clopidogrel are dose related. Moreover, in patients sustaining ACS while on maintenance
      clopidogrel treatment, reloading with 600 mg clopidogrel, resulted in further reduction in
      platelet aggregation, although the patients were not non-responders. Despite this, the effect
      of dose escalation has never been examined in patients resistant to clopidogrel. In the
      present study we wish to assess prospectively the effect of reloading with 600 mg
      clopidogrel, and double dose maintenance treatment (150 mg/day) for one month in acute
      myocardial infarction (AMI) patients who demonstrate non-respondese to clopidogrel.
    

Intervention name(s): clopidogrel
Intervention type(s): Drug
Intervention MeSH terms: Clopidogrel
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: clopidogrel; platelets; acute coronary syndrome; percutaneous coronary intervention
A First-in-human Study to Evaluate the Safety, Tolerability and Pharmacokinetics of LFX453
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this first-in human study is to demonstrate systemic and local tolerability
      and investigate pharmacokinetics of LFX453 after multiple topical applications in healthy
      subjects.

      The current study has been designed with three distinct parts. Part 1 focuses on safety and
      tolerability of once daily application on the back, prior to moving forward and assessing the
      safety and tolerability in more sensitive treatment areas in Part 2 or twice daily
      application in Part 3.
    


Intervention name(s): LFX453 H1; LFX453 L1; LFX453 H2; LFX453 L2; Imiquimod; Placebo 1; Placebo 2
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): LFX453 high dose cream 1; LFX453 low dose cream 1; LFX453 high dose cream 2; LFX453 low dose cream 2; Imiquimod cream; Placebo cream 1; Placebo cream 2
Intervention MeSH terms: Imiquimod
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Healthy volunteer
Randomized Study of Weekly Erythropoietin Dosing in Preterm Infants
Condition: Preterm Infants
MeSH terms: Premature Birth
Study type: Interventional
Phase: Phase 2

Summary: 
      Preterm infants are a risk for multiple transfusions, and the administration of human
      recombinant erythropoietin (Epo) has been shown to decrease transfusion requirements. Dosing
      usually occurs three times a week, but extended dosing schedules have been successful in
      adults. The investigators assessed weekly Epo dosing in preterm infants compared to standard
      three times weekly dosing.
    

Detailed description: 
      Erythropoietin (Epo) increases and maintains hematocrit using once weekly dosing in adults
      with anemia due to end stage renal disease. Epo is used in preterm infants to treat the
      anemia of prematurity, but has not been studied using once weekly dosing. We compared
      reticulocyte responses of once weekly Epo dosing with thrice weekly dosing in preterm
      infants.

      Infants ≤1,500 grams and ≥7 days of age were randomized to once weekly Epo, 1,200
      units/kg/dose, or thrice weekly Epo, 400 units/kg/dose, subcutaneously for 4 weeks, along
      with iron and vitamin supplementation. Complete blood counts, absolute reticulocyte counts
      (ARC), transfusions, phlebotomy losses, and adverse events were recorded.
    

Intervention name(s): three times weekly Epo; weekly Epo
Intervention type(s): Drug; Drug
Intervention description(s): Epo 400 units/kg administered subcutaneously three times per week for a total of 4 weeks; Epo 1,200 units/kg administered subcutaneously once a week for a total of 4 weeks
Other intervention name(s): Epoetin alfa; Procrit; Epoetin alfa; Procrit
Intervention MeSH terms: Epoetin Alfa
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: anemia; transfusions; erythropoiesis; neonate; preterm
Effects of Single-dose and Steady-state TPV/r on the Steady-state Pharmacokinetics of Clarithromycin and a Preliminary Assessment of the Effects of a Standard High-fat Test Meal on the Steady-state Pharmacokinetics of Tipranavir
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To determine the effects of single-dose and steady-state Tipranavir/Ritonavir (TPV/r) at 500
      mg/200 mg bid on the steady-state pharmacokinetics of clarithromycin and to determine the
      effects of a standard high-fat test meal on the steady-state pharmacokinetics of tipranavir.
    


Intervention name(s): Tipranavir; Ritonavir; Clarithromycin; High-Fat Test Meal
Intervention type(s): Drug; Drug; Drug; Other
Intervention MeSH terms: Ritonavir; Tipranavir; Clarithromycin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment