bioihbjkbjnl/mcl2 huggingface dataset:
WOEST ( What is the Optimal antiplatElet & Anticoagulant Therapy in Patients With Oral Anticoagulation and Coronary StenTing)
Condition: Anticoagulants; Platelet Aggregation Inhibitors; Stents; Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional
Phase: Phase 4

Summary: 
      The study will assess the hypothesis that the combination warfarin & clopidogrel 75 mg/day is
      superior to triple therapy (warfarin + clopidogrel 75mg/day + aspirin 80mg/day) with respect
      to bleeding complications while equally safe with respect to the prevention of thrombotic
      complications in patients with both indications for warfarin use and dual antiplatelet
      (clopidogrel 75mg/day + aspirin 80mg/day) treatment.
    

Detailed description: 
      Chronic oral antithrombotic treatment is necessary in patients with mechanical heart valves
      and in the majority of patients with atrial fibrillation. When these patients have to undergo
      Percutaneous Coronary Intervention (PCI) with stenting, there is also an indication for
      treatment with aspirin and clopidogrel. However, triple therapy is known to augment the risk
      for bleeding complications.Unfortunately, no prospective data are available to solve this
      issue. Nevertheless, it all comes down to finding the ideal therapy in patients with both
      atrial fibrillation and percutaneous intervention to prevent thrombotic complications (e.g.
      stent thrombosis) without increasing the risk of bleeding. This prospective randomised study
      will assess the hypothesis that in patients on warfarin therapy and indication for elective
      percutaneous intervention, the combination warfarin & clopidogrel 75 mg/day is superior to
      triple therapy treatment in reducing the risk of bleeds while equally safe with respect to
      the prevention of thrombotic complications
    

Intervention name(s): PCI (percutaneous coronary intervention)
Intervention type(s): Device
Intervention description(s): only patients scheduled for PCI can be included tough this intervention would also take place without this study. What we want to study is the difference in outcome after a little change in the antithrombotic treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Atrial fibrillation; Percutaneous coronary stenting; Bleeding complications; Triple therapy
A Phase 2 Study to Evaluate Immune Responses of FluMist®
Condition: Influenza Vaccine
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study is to describe the level of serum antibody and cellular
      immune responses conferred by FluMist and TIV against influenza virus strains.
    

Detailed description: 
      The primary objective of this study is to describe the level of serum antibody and cellular
      immune responses conferred by FluMist and TIV against antigenically matched and antigenically
      mismatched influenza virus strains.

      The secondary objective of this study is to describe the safety of FluMist and TIV in
      subjects 12 to <36 months of age.
    

Intervention name(s): TIV, Trivalent Inactivated Influenza Virus Vaccine; FluMist, Influenza Virus Vaccine Live
Intervention type(s): Biological; Biological
Intervention description(s): 0.25 mL will be administered intramuscularly for each of two doses; 0.5 mL will be administered intranasally (approximately 0.25 mL into each nostril) for each of two doses
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Live, attenuated influenza virus vaccine (LAIV); Trivalent inactivated influenza virus vaccine (TIV); FluMist
Investigations of Amygdala Function Using Neurophysiological Recording and Stimulation
Condition: Fear; PTSD; Panic Disorder
MeSH terms: Panic Disorder
Study type: Interventional

Summary: 
      This study aims to specifically examine the in vivo electrophysiology and effects of direct
      stimulation of the human amygdala during conditioned and evoked fear. Investigators will also
      examine amygdala electrophysiology and the effects of stimulation during tasks to examine the
      effects of reward on fear memory.

      This study will recruit subjects with a history of temporal lobe epilepsy (TLE) who have
      undergone neurosurgical implantation with FDA-approved, NeuroPace RNS devices for treatment
      of seizures. These patients provide a unique cohort with (Responsive Neurostimulation) RNS
      devices capable of both recording and stimulating the amygdala during performance of
      fear-based, behavioral tasks.
    


Intervention name(s): Amygdala recording and stimulation using Neuropace RNS; Behavioral tasks
Intervention type(s): Device; Behavioral
Intervention description(s): Subjects will undergo a series of different, fear-related, behavioral tasks while undergoing amygdala electrophysiology recording and stimulation using the Neuropace RNS devices.; Subjects perform a set of fear related behavioral tasks over 2 days, with 3 tasks each day.In addition to amygdala RNS recording and stimulation, recording of electroencephalography (EEG), electromyography (EMG), and electrodermal activity (EDA) will be performed using standard techniques to capture and quantify the fear response across all tasks.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Responsive neurostimulation; Amygdala electrophysiology; Neuropace RNS; Temporal lobe epilepsy; closed-loop brain stimulation
Involvement of Plasmatic Factors in the Peripheral Muscle Dysfunction of COPD Patients - In Vitro Study
Condition: Chronic Obstructive Pulmonary
Study type: Observational

Summary: 
      Chronic Obstructive Pulmonary Patients is a defined by persistent airflow limitation that is
      usually progressive and associated with an enhanced chronic inflammatory response in the
      airways and the lung to noxious particles or gases. It is associated with an atrophy of the
      skeletal muscle that impairs the patient's prognosis. The biological mechanisms of this
      muscle atrophy have not been elucidated, and the "spill-over theory" has recently emerged.
      Indeed, in COPD patients, the pulmonary inflammation is associated with a systemic low-grade
      inflammation, and the increased pro-inflamatory molelcules in the blood - which constitute
      the cellular micro-environement of the muscle fibre - could activate the mechanisms of the
      cell atrophy.
    


Intervention name(s): Determination of pro-inflammatory plasma factors
Intervention type(s): Other
Intervention description(s): Determination of pro-inflammatory plasma factors at COPD patients aged from 35 to 85 years old and Healthy subjects aged from 35 to 85 years old
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Chronic Obstructive Pulmonary Patients
      
Keywords: COPD (Chronic Obstructive Pulmonary Patients); Atrophy; cell cultur; systemic inflammation; Catabolism
Women Engaging in Quitting Smoking Together (WE QUIT)
Condition: Smoking Cessation
Study type: Interventional

Summary: 
      The long-term goal of this program of research is to develop and disseminate an efficacious
      intervention for weight concern that will significantly increase smoking cessation rates
      among women. The overall objective of this project is to develop this intervention and modify
      it based on piloting and feedback to ensure its feasibility and acceptability. These
      objectives will be accomplished by pursuing the following specific aim: 1) develop a
      group-based distress tolerance treatment for weight concern (DT-W) in female smokers and a
      comparison health education (HE) program and pilot both treatments with three groups of 10
      (total N = 30) female weight-concerned smokers (2 DT-W groups, 1 HE group).
    


Intervention name(s): Distress Tolerance Treatment for Weight Concern (DT-W); Health Education (HE)
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: smoking cessation; women
To Establish the Traditional Chinese Medicine Based Intelligent Personal Health Care System
Condition: Traditional Chinese Medicine Body Constitution
Study type: Observational

Summary: 
      Development of a New Generation Chinese Medicine Constitution Assessment Scale
    

Detailed description: 
      Development of a New Generation Chinese Medicine Constitution Assessment Scale:

      A. Analyzing the existing CCMQ and BCQ questionnaire syntax. B. Redesigning the scale's
      question statements. C. Reintegrating the scale items and constitutional characteristics. D.
      Testing and evaluating the reliability and validity of the questionnaire, cross-assessing
      with diagnoses from experienced Chinese medicine practitioners.

      E. Collecting feedback and reviewing modifications based on the responses from the general
      population questionnaire.
    

Intervention name(s): CCMQ questionnaire
Intervention type(s): Other
Intervention description(s): Test subjects were required to fill out our modified CCMQ (Constitution in Chinese Medicine Questionnaire) Questionnaire.
Observational model: Ecologic or Community
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The enrolled normal subjects were confirmed by the Association and the research Principal
        Investigator (PI). Subjects between the ages of 18 and 85 were included. We collected all
        of the subjects' basic information and administered the Chinese Medicine Constitution
        Assessment Scale.
Effect of Travoprost 0.004% on Retinal Oximetry in Primary Open Angle Glaucoma
Condition: Primary Open Angle Glaucoma
MeSH terms: Glaucoma; Glaucoma, Open-Angle
Study type: Interventional

Summary: 
      Glaucoma is the second leading cause of blindness among seniors in Canada. It is often
      associated with an elevated intraocular pressure (IOP), but its exact mechanism is still
      largely unknown. Some studies have shown a link between glaucoma and changes in the amount of
      oxygen in the veins of the eye. The study aims to compare the amount of oxygen in ocular
      veins among three different groups using a spectrophotometer. This instrument is linked to a
      camera and can measure the quantity of oxygen in the veins using different characteristics of
      the blood inside.

      The groups of the study are: patients without glaucoma, patients suspected of glaucoma and
      patients newly diagnosed with glaucoma. The drug the investigators are using, Travoprost
      0.004%, will only be administered to the groups suspected or diagnosed with glaucoma.
      Travoprost 0.004% is already approved for use in Quebec and is part of standard care. Ten
      patients will be recruited into each group for a total of 30 patients in this study. All
      patients for the suspected or diagnosed groups will be recruited from the Jewish General
      Hospital. Subsequently all testing will be done at the École d'optométrie, Université de
      Montréal
    


Intervention name(s): placebo; travoprost
Intervention type(s): Drug; Drug
Intervention description(s): Placebo; Travatan Z is administered to newly diagnosed glaucoma patient
Other intervention name(s): travatan
Intervention MeSH terms: Travoprost
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: primary open angle glaucoma; retinal oximetry
Safety Study of Mesenchymal Precursor Cells in Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study is being conducted to assess the overall safety and tolerability of a single
      intravenous infusion of three doses of Mesenchymal Precursor Cells versus Placebo in subjects
      with Type 2 Diabetes inadequately controlled on Metformin.
    


Intervention name(s): Mesenchymal Precursor Cells (MPCs); Mesenchymal Precursor Cells (MPCs); Mesenchymal Precursor Cells (MPCs)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Single intravenous infusion of MPCs Dose 1; Single intravenous infusion of MPCs Dose 2; Single intravenous infusion of MPCs Dose 3
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Study to Determine the Equivalence of Three Products Containing Metronidazole Benzoate.
Condition: Bacterial Infections
MeSH terms: Bacterial Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine whether Terix Labs Ltd Metronidazole benzoate (400
      mg Metronidazole Per Sachet Oral Granules) is bioequivalent to 500 mg Sanofi-aventis Flagyl
      125 mg/5 ml (125 mg Metronidazole Per 5 ml Suspension) and to Zentiva Flagyl™ 400 mg Tablets
      (400 mg Metronidazole Per Film Coated Tablets).
    

Detailed description: 
      This study is a pilot study exploited for exploratory purposes to compare the absorption and
      disposition kinetics of three products containing metronidazole under fasting conditions.
      These products are: Metronidazole benzoate (formula A), Test product manufactured by ONE
      PHARMA, Greece. Flagyl 125 mg/5 ml (formula B), a Reference product manufactured by Unither
      Liquid Manufacturing, France and Flagyl™ 400 mg Tablets (formula C), a Reference product
      manufactured by Famar Health Care Services, Spain. The bioequivalence of a single 400 mg dose
      of products A and C, and a single 500 mg dose of product B will be assessed by comparing the
      pharmacokinetic parameters derived from the plasma concentration-time profiles for
      metronidazole.
    

Intervention name(s): Metronidazole benzoate; Flagyl 125 mg/5 ml oral suspension; Flagyl 400 mg Tablets
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Single oral dose of 400 mg; Single oral dose of 500 mg (20 ml suspension); Single oral dose of 400 mg
Intervention MeSH terms: Metronidazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Sleep Restriction and Energy Expenditure
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      Each 4-day period will follow the same protocol. Basically, for the entire study, we will
      prepare all of the subject's food and will require him or her to eat all of the food that we
      give at the times we tell them to eat. The subject will arrive at the hospital on the evening
      of day 1, and become inpatients. On day 2, the subject will be permitted to leave the
      hospital campus under the supervision of the research staff. On day 3, they will be required
      to stay in a small room called a metabolic chamber for 24 hours. This room measures how many
      calories you burn in one day. On day 4, we will measure the subject's energy expenditure in
      response to a breakfast meal. They will be given breakfast and the number of calories that
      they burn after that meal will be measured over a 6-hour period. Then the subject will be
      discharged at the end of the test. The 2 study periods will differ only in bedtimes and
      wakeup times. During one period, the subject will go to bed at 1 am and wake up at 5 am and
      during the other period they will go to bed at 11 pm and wake up at 7 am.
    

Detailed description: 
      Sleeping metabolic rate will be measured using a metabolic chamber on the night of day 2.
      During day 3, 24-hour energy expenditure (including a second night of measurement) will be
      measured in the metabolic chamber. On this day, the participant will perform 2 bouts of
      physical activity on a stationary bicycle for 15 minutes each bout. This will give us a
      measurement of physical activity energy expenditure. On day 4, at 7 am, the participant will
      exit the metabolic chamber and will enter a different, smaller metabolic chamber for the
      measurement of energy expenditure in response to a meal. This measurement will start at
      approximately 8 am with assessment of the resting metabolic rate (45 minutes). The
      participant will then be given a high-fat meal replacement to consume over 10 minutes. Energy
      expenditure measurements continue in the metabolic chamber for a 6-hour period.
    

Intervention name(s): Short Sleep; Habitual sleep
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants will be restricted in sleep and only allowed to sleep from 1 am to 5 am.; Participants sleep 8 h/night throughout the study phase (from 11 pm to 7 am)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Obesity; Resting Metabolic Rate; Sleep; Eating
Evaluation of the Immediate Effect and Safety of DMA™ Novel Muscle Stimulation Technology
Condition: Skin Laxity; Muscle Contracture
MeSH terms: Contracture
Study type: Interventional

Summary: 
      A total of at least 15 and up to 17 healthy subjects at a single site, aged 25-45 years old,
      who wish to receive a lifting effect and improved muscle definition, will be included in the
      study.

      The procedure will include treatments with the Legend Pro™ DMA™ technology. Photos will be
      obtained at pre-defined time points throughout the study.
    

Detailed description: 
      Single center, prospective, open Label with Before & After Study Design. This study is
      designed to evaluate the immediate efficacy and safety of Legend Pro™'s DMA™ muscle
      stimulation technology. Treatment areas will include the face, buttocks, or abdominal region.
      Each subject will receive 1 treatment with no follow-up visits required. Interim assessment
      will be held after half of the study population has received treatment.

      The study population will be divided into three arms as follows:

        -  5 female subjects will receive treatment in the face area

        -  5 female subjects will receive treatment in the buttocks area

        -  5 male subjects will receive treatment in the abdominal region
    

Intervention name(s): DMA treatment
Intervention type(s): Device
Intervention description(s): Each arm will receive the DMA treatment in a specific area on the body to observe immediate effect.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effect of Oral Guaifenesin on Pediatric Chronic Rhinitis: A Pilot Study
Condition: Chronic Rhinitis
MeSH terms: Rhinitis
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a 14-day, randomized, placebo-controlled, parallel group, masked clinical trial of
      oral guaifenesin for the therapy of Chronic Rhinitis (CRS) in 36 children between the ages of
      7 and 18 years. The study investigates the effectiveness of guaifenesin in the relief of
      nasal symptoms in children with CRS using the sinonasal 5 survey (SN-5) in comparison to
      nasal airway volume, and biophysical properties of nasal secretion. The investigators
      hypothesize that Guaifenesin use over a period of 14 days improves subjective nasal
      complaints in pediatric patients with chronic rhinitis and nasal congestion, as measured by
      the SN-5 survey compared to use of placebo. There will be an observed improvement in nasal
      volume and cross-sectional area following use of guaifenesin, and nasal secretions will have
      more favorable mucociliary and sneeze clearability compared to use of placebo.
    


Intervention name(s): Placebo; Guaifenesin
Intervention type(s): Drug; Drug
Intervention description(s): Children aged 7-11 years old will receive placebo 200 mg three times a day (TID), while children older than 12 will receive Placebo 400 mg TID.; Children aged 7-11 years old will receive guaifenesin 200 mg TID, while children older than 12 will receive guaifenesin 400 mg TID.
Intervention MeSH terms: Phenylpropanolamine; Guaifenesin; Chlorpheniramine, phenylpropanolamine drug combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Single Dose Pharmacokinetics (PK) Study of GSK2434735 in Healthy Male Volunteers
Condition: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      An exploratory First Time in Human (FTIH) study investigating the pharmacokinetics,
      immunogenicity, safety and tolerability of GSK2434735 administered as a single low dose in
      healthy male subjects
    

Detailed description: 
      Interleukin-13 (IL-13) and IL-4 are mediators in the pathogenesis of established asthmatic
      disease. GSK2434735 is a bispecific antibody to IL-13 and IL-4. The purpose of this open
      label, sequential cohort, exploratory First Time in Human (FTIH) study is to evaluate the
      pharmacokinetics (PK) profile of GSK2434735 after a single low intravenous or subcutaneous
      dose in healthy male volunteers, and to assess if the pharmacokinetics (PK) parameters can be
      scaled from monkey to man. In addition, the safety and tolerability will be monitored and the
      study will assess if antibodies are generated to GSK2434735.
    

Intervention name(s): Intravenous (IV) single dose; Subcutaneous (SC) single dose
Intervention type(s): Drug; Drug
Intervention description(s): GSK2434735 administered as a single intervenous dose at the beginning of the study; GSK2434735 administered as a single subcutaneous dose at the beginning of the study
Other intervention name(s): GSK2434735; GSK2434735
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: immunogenicity; GSK2434735; pharmacokinetics (PK); PK; biospecific antibody