bioihbjkbjnl/mcl2 huggingface dataset:
Comparative Glucose Clamp Study of Wockhardt's Recombinant Insulin Analog Glargine(Glaritus) With Lantus in T1DM
Condition: Type1 Diabetes
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of this trial is to demonstrate bioequivalence of Glaritus® to Lantus® with regard to
      its total and to its maximum serum insulin concentrations.
    

Detailed description: 
      The purpose of this study is to test for bioequivalence based on the pharmacokinetic
      parameter AUC INS-GLR 0-24h and on pharmacodynamic parameter AUC GIR 0-24h between the two
      long-acting insulin glargine formulations, Lantus® and Wockhardt's Glaritus® in subjects with
      type1 diabetes as well as assessing safety and local tolerability of the two insulin
      preparations.
    

Intervention name(s): Glargine
Intervention type(s): Biological
Intervention description(s): dosage form: Subcutaneous injection
Intervention MeSH terms: Insulin Glargine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Health Services Research
Evaluation of Pandemic Influenza A (H1N1) Vaccine in Chronic and or Immunocompromised Patients, Elderly and Pregnants
Condition: Immunocompromised Patients; Safety of Pandemic Influenza A (H1N1)Vaccine; Immunogenicity of Pandemic Influenza A (H1N1)Vaccine
MeSH terms: Influenza, Human
Study type: Observational

Summary: 
      The objective of this study is to describe the safety and immunogenicity of a non-adjuvanted
      vaccine against pandemic influenza A (H1N1)in patients with chronic and or immunocompromised
      disease, elderly and pregnants. The primary immunological endpoint is to analyze the
      proportion of subjects with antibody titers of 1:40 or more on hemagglutination-inhibition
      assay 21 days after 1 dose of the vaccine. Volunteers will be monitored for safety during 21
      days after vaccination. Volunteers will be recruited based on inclusion and exclusion
      criteria. Vaccine composition is: 15 micrograms of split inactivated virus
      (A/California/7/2009 (H1N1) (NYMC X179A). The hypothesis of the study is that the vaccine is
      safe and immunogenic in the volunteers recruited.
    


Intervention name(s): Split inactivated A/California/7/2009 (H1N1) (NYMC X-179A) VIRUS
Intervention type(s): Biological
Intervention description(s): 1 full dose of 15 micrograms, IM, for volunteers 9 years of age or older; children 6 months to 2 years of age, half of the dose,IM, with 21 days interval; children 3 years old up to 8 years old, 1 full dose, IM, twice, with 21 days interval.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Volunteers with chronic and or immunocompromised disease, elderly and pregnant in follow -
        up at the institutions participants in the study will be recruited.
      
Keywords: Immunocompromised patients; Safety of pandemic influenza A (H1N1)vaccine; Immunogenicity of pandemic influenza A (H1N1)vaccine
Effects of Bobath Technique Versus Task Oriented Training on Gross Motor Function in Cerebral Palsy Children
Condition: Cerebral Palsy
MeSH terms: Cerebral Palsy
Study type: Interventional

Summary: 
      Cerebral palsy is the most familiar motor disorder of childhood. Consistent with the results
      of recent scientific researches BOBATH approach in physical restoration of youngsters with
      cerebral palsy promotes formation of motor skills. Improvement in mobility has been primary
      goal in treatment of CP. There are only a few studies available within the efficacy of
      "task-oriented training" to improve gross motor function in CP child. Hence, this comparative
      study is undertaken to gauge the effect of task-oriented training verses neurodevelopmental
      training on gross motor function in cerebral palsy child. Objective of this study is to find
      out the effects of BOBATH technique and Task Training on gross motor function in cerebral
      palsy children. A Convenient sample of Cerebral Palsy children fulfilling inclusion and
      exclusion criteria, from physiotherapy OPD of Allied & DHQ hospitals of Faisalabad will be
      considered. Informed consent will be taken from all patient's caregivers. Patients will be
      divided into two groups through chit draw randomization. Age of children will be 3 years to
      10 years without discrimination of gender. Group A will receive BOBATH training and Group B
      will receive task training. Data will be collected through Gross Motor Function Measure
      (GMFM-88). Data analyses using SPSS version 25 as a statistical tool.
    


Intervention name(s): BOBATH technique; Task training
Intervention type(s): Other; Other
Intervention description(s): In group A (BOBATH) one session per day for three days lasting 1 hour for 3 months. Position transitions such as turning from supine to prone or from prone to supine from sitting to standing are facilitated according to the needs. Balance reflexes are attempted to stimulate by using a CP ball. Ambulation training appropriate to the child's motor development. Additionally, passive stretching of spastic muscle reduces spasticity and facilitates the motor function; In group B (task training) will be applied for 60 minutes per day, 3 times per week for 3 months the individual session lasted roughly 10 minutes for each activity. Standing from a seated situation; (ii) reaching for an object high up, which required ankle plantarflexion from the standing position, and go back to the starting position with the heel leaning on the floor; (iii) stepping on and off a bench; (iv) walking up and downstairs. (10) (v) Drinking water hold the cup stable and drink it by lifting it at an appropriate speed and power (vi) Moving a rubber ball, the task involved taking a 6.5 cm diameter rubber ball and placing it in a basket with a diameter of ten cm (the basket location was moved in various directions).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Redox Status and Immune Function
Condition: Skeletal Muscle Damage; Aseptic Inflammation; Skeletal Muscle Function
MeSH terms: Inflammation
Study type: Interventional

Summary: 
      In this investigation the investigators utilized N-acetylcysteine (NAC) supplementation to
      enhance reduced glutathione (GSH) stores during an 8-day recovery period from a strenuous
      eccentric exercise protocol in order to test the hypotheses: i) redox status perturbations in
      skeletal muscle are pivotal for the immune responses and ii) antioxidant supplementation may
      alter immune cell responses following exercise-induced muscle microtrauma.
    

Detailed description: 
      The major thiol-disulfide couple of GSH and oxidized glutathione (GSSG) is a crucial
      regulator of the main transcriptional pathways regulating aseptic inflammation and recovery
      of skeletal muscle following aseptic injury. Antioxidant supplementation may hamper
      exercise-induced inflammatory responses.

      The objective was to examine how thiol-based antioxidant supplementation affects immune
      mobilization following exercise-induced skeletal muscle microtrauma. In a two-trial,
      double-blind, crossover, repeated measures design, 10 young men received either placebo or
      NAC (20 mg/kg/day) immediately after a muscle-damaging exercise protocol (300 eccentric
      contractions) and for eight consecutive days. Blood sampling and performance assessment were
      performed pre-exercise, 2h post-exercise and daily for 8 consecutive days.
    

Intervention name(s): n-acetylcysteine; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 20 mg//kg/day, orally, daily for eight days following exercise; 500 mL orally, daily for eight days following exercise
Other intervention name(s): NAC
Intervention MeSH terms: Acetylcysteine; N-monoacetylcystine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: muscle injury; exercise; redox status; immune cells
Correlation of Non Invasive Hemoglobin Measurement With Laboratory Hemoglobin Measurement in Living Liver Donors
Condition: Anesthesia
Study type: Observational [Patient Registry]

Summary: 
      Pulse CO-Oximetry (Masimo Corp, Irvine, CA, USA) is a method that allows non-invasive
      continuous hemoglobin (Hb) measurement. This technology measures continuous Hb with a
      multi-wavelength spectrophotometric fingertip sensor.

      Aim of investigators in this study is to make continuous Hb measurement with Pulse
      CO-Oximetry method in living liver donors, to compare these measurements with the laboratory
      results routinely taken during the operation, to determine the level of correlation for this
      patient group.
    

Detailed description: 
      Continuous Hb measurement with Pulse CO-Oximetry (SpHb) can be usefull for living liver donor
      and improve the quality of intraoperative care. This technology measures continuous Hb with a
      multi-wavelength spectrophotometric fingertip sensor.

      The perfusion index (PI) is the ratio of the pulsatile blood flow to the nonpulsatile or
      static blood in peripheral tissue. Perfusion Index thus represents a noninvasive measure of
      peripheral perfusion that can be continuously and noninvasively obtained from a pulse
      oximeter. Changes in PI can also occur as a result of local vasoconstriction (decrease in PI)
      or vasodilatation (increase in PI) in the skin at the monitoring site. These changes occur
      with changes in the volumeof oxygenated bloodflow in the skin microvasculature. PI values can
      change due to surgical process and may affect SpHb measurement.

      Aim of investigators in this study is to make continuous Hb measurement with Pulse
      CO-Oximetry method in living liver donors before and after surgery incision, to compare these
      measurements with the laboratory results routinely taken during the operation, to determine
      the level of correlation for this patient group.
    

Intervention name(s): Masimo Model RDS7A
Intervention type(s): Device
Intervention description(s): Masimo monitoring platform equipped with Radical-7 Pulse CO-Oximeter fingertip probe for measurement non-invazive hemoglobin level (SpHb) an perfusion index (PI)
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        According to ASA physical status classification system ASA 1-2 cases scheduled for
        hepatectomy for liver transplantation
      
Keywords: hemoglobin level; Pulse CO-Oximetry; intraoperative
A Study of Tomato Products and Disease Risk
Condition: Inflammation
MeSH terms: Inflammation
Study type: Interventional

Summary: 
      The purpose of this research study is to test whether certain compounds in tomatoes will help
      reduce factors in the subject's blood associated with disease risk. The investigators want to
      know if the tomato-associated compounds will lower or improve the status of these factors,
      like cholesterol and inflammation. In this research study, the subject will be asked to
      consume high fat test meals on two separate occasions. The investigators want to see how the
      subject's body responds to a standard high fat meal, one meal with tomato products and one
      meal without tomato products. The investigators will measure the subject's blood throughout
      the study period to determine if consumption of tomato products reduces factors in their
      blood associated with disease risk.
    

Detailed description: 
      This study will take three weeks at most, and require one initial screening visit lasting
      approximately 45 minutes and two study visits each lasting approximately 6 - 8 hours. The
      investigators are looking for healthy, non-smoking male and female volunteers between the
      ages of 18 - 65, with no medical history of diabetics, heart, lung, kidney, stomach, or liver
      disease.

      The initial screening visit will determine subject' eligibility through height, weight and
      waist circumference measurements, blood glucose (finger prick) test and a fasting screening
      blood draw. There will be no compensation for the screening visit, other than transportation
      costs.

      If subject qualify, subject will continue to the two study visits. Each visit will require
      subject to have blood drawn several times during subject' study visit (total amount of blood
      equal to approximately 1 ½ tablespoons). To make this process more tolerable, a registered
      nurse will place a catheter (similar to what happens when you give blood) into subject's vein
      for ease in drawing blood. After the catheter placement and the first blood draw, subject
      will be asked to eat the test meal (tomato or non-tomato meal) and then subject will continue
      to have blood taken at specific time points for the next 6 hours. The investigators will also
      do an ultrasound on subject's arm to measure blood flow both before eating and midway through
      the 6 - hour study visit. The investigators will ask that subject not consume tomatoes or
      tomato products during the course of the study and record all food and beverages consumed on
      certain days.
    

Intervention name(s): Tomato; Non-tomato
Intervention type(s): Other; Other
Intervention description(s): Tomato with high carb/fat meal; Non-tomato with high carb/fat meal
Other intervention name(s): Active Comparator; Placebo Comparator
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Tomato; Nutrition
Effects of Buprenorphine/Naloxone Administered in Different Ways For Treating Opioid Dependence
Condition: Opioid-Related Disorders
MeSH terms: Opioid-Related Disorders
Study type: Interventional

Summary: 
      Buprenorphine is a treatment for opioid dependence. Naloxone is given in addition to
      buprenorphine in order to limit the abuse potential that is commonly associated with
      buprenorphine. The purpose of this study is to examine the effects of buprenorphine/naloxone
      when given through different routes and at different doses.
    

Detailed description: 
      Buprenorphine, a mixed agonist-antagonist opioid (or partial agonist), is a safe and
      effective treatment for opioid dependence. However, there is concern that buprenorphine may
      be abused due to its high abuse potential. A sublingual buprenorphine/naloxone combination
      tablet may reduce the risk of abuse associated with buprenorphine alone. The purpose of this
      study is to characterize the effects of buprenorphine/naloxone in opioid-dependent
      individuals.

      This study will last 10 weeks. Participants will stay in a residential research unit, and
      will be maintained on oral hydromorphone (10 mg). During twice-weekly experimental sessions,
      participants will be randomly assigned to receive either sublingual tablets, intramuscular
      injections, or a placebo. The 15 conditions studied will include: sublingual or intramuscular
      buprenorphine/naloxone (1/0.25 mg, 2/0.5 mg, 4/1 mg, 8/2 mg, and 16/4 mg), 0.25 mg of
      intramuscular naloxone (antagonist control), 10 mg of intramuscular hydromorphone (agonist
      control), sublingual and intramuscular buprenorphine (8 mg), and placebo.
    

Intervention name(s): Buprenorphine
Intervention type(s): Drug
Intervention description(s): single doses given by sublingual and parenteral routes
Intervention MeSH terms: Buprenorphine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: opiate dependence
Study of Proellex in Pre-menopausal Women With Symptomatic Uterine Fibroids
Condition: Uterine Fibroids
MeSH terms: Leiomyoma; Myofibroma
Study type: Interventional
Phase: Phase 2

Summary: 
      Two (2) dose levels of Proellex or placebo will be administered once-daily for up to 91 days.
      Following screening and a pre-treatment endometrial biopsy, subjects will be followed monthly
      for the three month treatment phase.
    

Detailed description: 
      Two (2) dose levels of Proellex or placebo will be administered once-daily for up to 91 days.
      Following screening and a pre-treatment endometrial biopsy, subjects will be followed monthly
      for the three month treatment phase. At the three-month treatment visit, subjects will be
      entered into an open-label extension treatment protocol, if deemed eligible. At four months
      after their first treatment visit, subjects not electing to enter the open-label study will
      be assessed at a final follow-up visit.
    

Intervention name(s): 12.5 mg Proellex; 25 mg Proellex; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 12.5 mg Proellex administered orally daily; 25 mg Proellex administered orally daily; Administered orally daily
Other intervention name(s): CDB-4124; Telapristone acetate; CDB-4124; Telapristone acetate; Dummy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Uterine fibroids
Pharmacodynamic Bioequivalence of Metered Dose Inhalers of Albuterol Sulfate in Patients With Stable Mild Asthma
Condition: Mild Persistent Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to demonstrate the pharmacodynamic bioequivalence of the test
      product to the reference product, using bronchoprovocation (methacholine challenge testing)
      in adult patients with stable mild asthma.
    

Detailed description: 
      A Multicenter, Double-Blind, Double-Dummy, Placebo-Controlled, 5-Treatment, Randomized,
      Crossover Study to Demonstrate the Pharmacodynamic Bioequivalence of Test and Reference
      Metered Dose Inhalers containing Albuterol Sulfate using Bronchoprovocation in Adult Patients
      with Stable Mild Asthma
    

Intervention name(s): methacholine chloride; placebo ProAir HFA; ProAir HFA; Lupin albuterol HFA MDI; placebo Lupin albuterol HFA MDI
Intervention type(s): Other; Drug; Drug; Drug; Drug
Intervention MeSH terms: Albuterol; Procaterol; Methacholine Chloride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Comparison of Sugammadex Administered at 1-2 Post Tetanic Counts (PTCs) or Better With Neostigmine Administered as Per Standard of Care to Reverse Rocuronium-Induced Neuromuscular Blockade in Adults Undergoing Elective Open Abdominal Procedure (19.4.334) (P05774)
Condition: Anesthesia
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary purpose of this study is to compare the incidence of

      residual neuromuscular blockade at the time of tracheal extubation after reversal of
      rocuronium bromide-induced neuromuscular blockade by 4 mg/kg sugammadex with that of 50 µg/kg
      neostigmine. Residual neuromuscular blockade is defined as the fourth twitch to first twitch
      (T4/T1) ratio of

      < 0.90.
    

Detailed description: 
      Undetected residual neuromuscular blockade is common in the post-anesthesia care

      unit (PACU). In fact, 16%-42% of patients receiving intermediate-acting muscle

      relaxants in the operating room have T4/T1 ratios <0.7-0.8 in the PACU. Respiratory and
      pharyngeal muscle function can be adversely affected during minimal neuromuscular blockade.
      Studies in awake volunteers and surgical patients have demonstrated that T4/T1 ratios of 0.7
      - 0.9 are associated with impaired airway protective reflexes, upper airway obstruction, a
      decreased hypoxic ventilatory response, and post-operative hypoxemia. The incidence and
      severity of residual neuromuscular blockade at the time of tracheal extubation will be
      evaluated to determine how these influence the length of stay in the operating room and PACU.
    

Intervention name(s): Sugammadex; Neostigmine; Rocuronium
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Participants received 4 mg/kg sugammadex at 1-2 Post Tetanic Counts (PTCs) or better after the last dose of rocuronium bromide.; Participants received 50 µg/kg neostigmine combined with 10 µg/kg glycopyrrolate after the last dose of rocuronium bromide as per standard of care.; Participants received a single intubation bolus dose of 0.6 mg/kg rocuronium bromide, followed if necessary to maintain neuromuscular blockade by one or more single bolus dose(s) of 0.15 mg/kg rocuronium bromide.
Other intervention name(s): Org 25969; SCH 900616; MK-8616; Bridion®; Prostigmin®; Rocuronium bromide; Esmeron®
Intervention MeSH terms: Bromides; Rocuronium; Neostigmine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Cognitive Dysfunction in MS: Using Altered Brain Oscillation to Link Molecular Mechanisms With Clinical Outcomes
Condition: Pediatric Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Cognitive Dysfunction
Study type: Observational

Summary: 
      Up to 65% of patients with multiple sclerosis (MS) experience cognitive dysfunction.
      Diminution of mental capacity has a pervasive and profound impact on their quality of life.
      Subtle changes in white matter predict cognitive changes in these patients but how this
      disrupts brain function remains unclear. Development of effective therapeutics to restore
      normal cognition hinges on elucidating these functional changes. The investigators seek to
      uncover the patho-physiological basis for cognitive decline in MS. The investigators
      hypothesize that cognitive decline originates from disrupted gamma oscillations and that
      gamma oscillations are disrupted by molecular changes triggered by demyelination.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Seven patients who have pediatric-onset multiple sclerosis and 7 healthy (non-patient)
        children are expected to participate in this study.
Cerebral Microembolism in Cardiology
Condition: Cerebral Embolism
MeSH terms: Intracranial Embolism; Embolism
Study type: Observational

Summary: 
      During different interventional cardiology procedures we aim to identify cerebral microemboli
      load. Further we aim to differentiate the quality and the quantity of cerebral microemboli.We
      will measure cerebral microemboli in different interventional phases, e.g. during valve
      deployment, rapid pacing, post-implantation.
    


Intervention name(s): Transcranial Doppler (TCD) ultrasound measurement
Intervention type(s): Device
Intervention description(s): Non-invasive measurement of cerebral embolic load and blood flow using TCD
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients undergoing Interventional cardiology procedure (TAVI, MitraClip, TricuspidalClip)