bioihbjkbjnl/mcl2 huggingface dataset:
Population Pharmacokinetics and Safety of Oral Posaconazole in Children With Leukemia
Condition: Leukemia, Acute
MeSH terms: Leukemia
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study is designed to evaluate the safety, efficacy and Population Pharmacokinetics of
      Oral Posaconazole in Children with leukemia.
    

Detailed description: 
      Posaconazole as a new triazole antifungal agent with broad spectrum coverage, was recommended
      for prophylaxis of invasive fungal disease in adults. Some studies have demonstrated the
      relationship between posaconazole plasma concentration and efficacy and few data have been
      published in children with leukemia.The purpose of this study is to describe the off-label
      use of posaconazole oral suspensions in children;to figure out the relationship between
      concentration and clinical outcomes/ adverse events;to identify factors that influence plasma
      concentration.
    

Intervention name(s): posaconazole oral suspensions
Intervention type(s): Drug
Intervention description(s): posaconazole oral suspensions（5mg/kg/d,tid) will be administered specially febrile neutropenia patients four times a day and blood samples will be taken any hours after the first dose at least Day 7.
Intervention MeSH terms: Posaconazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effects of Intravenous Fluids on Perfusion Index and Pleth Variability Index
Condition: Perfusion
Study type: Interventional

Summary: 
      This study is aimed to assess the effects of intravenously administered three fluid types on
      perfusion index and pulse variability index in patients during preoperative period. Patients
      will be randomly divided into three groups. Baseline, 5th, 10th, 15th, 20th, 25th and 30th
      min non-invasive blood pressure, oxygen saturation, heart rate, room temperature, perfusion
      index and pulse variability index will be measured and recorded.
    

Detailed description: 
      Intravenous volume replacement alter the dynamics of microcirculation. Perfusion index and
      pulse variability index are the recent parameters to evaluate the tissue microcirculatory
      condition. This study is aimed to assess the effects of intravenously administered three
      fluid types on perfusion index and pulse variability index in patients during preoperative
      period. Patients will be taken to recovery room in the operating theatre and wait for 15
      minutes to balance the skin temperature of the patients to the environment. Patients will be
      randomly divided into three groups using closed envelope technique as Group L (received 500
      ml of Ringer's lactate), Group S (500 ml of saline) and Group H (received 500 ml of 6%
      hydroxyethylstarch). Baseline, 5th, 10th, 15th, 20th, 25th and 30th min non-invasive blood
      pressure, oxygen saturation, heart rate, room temperature, perfusion index and pulse
      variability index will be measured and recorded.
    

Intervention name(s): sodium chloride; Hydroxyethylstarch; Ringer-Lactate Infusion Solution Bag
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 500 ml of 0.9% isotonic sodium chloride; 500 ml of 6% Hydroxyethylstarch; 500 ml of Ringer-Lactate Infusion Solution Bag
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Bioequivalence Study of Carvedilol 12.5mg Tablets Under Fed Conditions
Condition: Healthy
MeSH terms: Disease
Study type: Interventional

Summary: 
      The objective of this study was to compare the single-dose oral bioavailability of Carvedilol
      12.5 mg tablets of Ranbaxy Laboratories with Coreg 12.5 mg tablets of Glaxosmithkline in
      healthy, adult, human subjects under fed conditions.
    

Detailed description: 
      The study was conducted as an open label, balanced, randomized, two-treatment, two-sequence,
      two-period, single-dose, crossover, bioavailability study on carvedilol formulation comparing
      carvedilol 12.5mg of Ohm Laboratories, Inc. (a subsidiary of Ranbaxy pharmaceuticals Inc,
      USA) with Coreg® 12.5mg tablet (containing carvedilol 12.5 mg) of GlaxoSmithKline, USA in
      healthy, adult, male, human subjects under fed condition.

      Forty healthy, adult, human subjects who met the inclusion and exclusion criteria as
      described in the protocol were enrolled in the study. Thirty-nine subjects completed both the
      periods of the study
    

Intervention name(s): Carvedilol 12.5 mg tablets
Intervention type(s): Drug
Intervention description(s): bioequivalence Carvedilol 12.5 mg tablets fed conditions
Intervention MeSH terms: Carvedilol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: bioequivalence Carvedilol 12.5 mg tablets fed conditions
An Exploratory Study of High-dose Glivec in Patients With CML-CP Using Molecular Endpoints
Condition: CML; Imatinib
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is locally amended study from CSTI571K2301 to evaluate the efficacy and safety of
      high-dose Glivec in Korean patients group with chronic phase of CML. Molecular response at 60
      months after Glivec administration will be described.
    


Intervention name(s): high-dose imatinib
Intervention type(s): Drug
Intervention description(s): Study patients will receive 400 mg twice daily oral administration in the morning and the evening.
Intervention MeSH terms: Imatinib Mesylate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Speed of Processing Training to Improve Cognition in Traumatic Brain Injury and Mild Cognitive Impairment
Condition: Traumatic Brain Injury; Mild Cognitive Impairment
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Wounds and Injuries; Cognitive Dysfunction
Study type: Interventional

Summary: 
      The purpose of this research study is to investigate the effectiveness of a technique
      designed to improve processing speed (i.e. the amount of time it takes to process
      information) in a Traumatic Brain Injury (TBI) population. The study is designed to study how
      well this technique can help people with TBI increase their processing speed and their
      ability to function better in everyday life.
    

Detailed description: 
      The current proposal is designed to apply this treatment protocol to a large sample of
      individuals with moderate to severe TBI with documented impairment in PS. The goals of the
      trial are to (a) test the efficacy of this treatment protocol within a TBI population, (b)
      evaluate the impact of the treatment on everyday functioning, (c) evaluate the longer-term
      efficacy of the treatment, and (d) examine the utility of booster sessions in facilitating
      longer-term treatment effects. Individuals with moderate to severe TBI, with documented
      impairment in PS, will be randomly assigned to a treatment group or a control group. Both
      groups will undergo baseline, immediate post-treatment and long-term follow-up assessment
      consisting of: (1) a standardized neuropsychological battery and (2) an assessment of global
      functioning examining the impact of the treatment on daily activities. This design will allow
      us to assess the efficacy of SPT in persons with TBI and evaluate its impact on everyday
      life.
    

Intervention name(s): Speed of Processing Training; Placebo Control
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Processing Speed; Cognition; Intervention; Traumatic Brain Injury; Mild Cognitive Impairment
Training Executive Functions to Facilitate Recovery Following Traumatic Brain Injury
Condition: Traumatic Brain Injury; Brain Injuries, Traumatic
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Wounds and Injuries
Study type: Interventional

Summary: 
      The purpose of this research study is to investigate different types of task training to
      determine if training improves thinking processes following traumatic brain injury.
    


Intervention name(s): Task Switching Training; Control Task
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants will complete four, one-hour training sessions in which they will practice switching between tasks within an alternating runs task switching paradigm.; Participants will complete four, one-hour training sessions in which they will perform a single task each session
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Physiological Validation of Current Machine Learning Models for Hemodynamic Instability in Humans
Condition: Hypotension and Shock
MeSH terms: Hypotension
Study type: Interventional

Summary: 
      This study will be collecting data on participants undergoing lower body negative pressure
      (LBNP) to simulate progressive blood loss. The goal of the study is to collect data to allow
      for development of an algorithm with machine learning to predict blood pressure responses to
      hyporvolemia by analyzing the arterial waveforms collected during LBNP.
    

Detailed description: 
      Death from exsanguination continues to be a major problem in combat casualty care and the
      care of civilians subjected to trauma. The ability to detect significant blood loss using
      traditional vital signs (heart rate, blood pressure) is marginal due to a variety of
      compensatory mechanisms that maintain blood pressure in the face of marked reductions in
      circulating blood volume. Along these lines, it is critical to develop monitoring devices and
      algorithms to non-invasively assess central blood volume in humans for the purposes of
      facilitating more timely interventions. The standard way to simulate hemorrhage in humans is
      to use Lower Body Negative Pressure (LBNP). In this technique, the lower body of a supine
      volunteer is enclosed in an airtight container while suction is applied to cause venous
      pooling in the legs and reduce central blood volume. This technique generates many
      physiological adaptations that are similar to that observed during blood loss studies in
      animals and human volunteers. Thus, the purpose of this study is to obtain data for use in
      developing monitoring technology to detect hemorrhage and other surrogate markers of central
      blood volume in humans.
    

Intervention name(s): Assigned Interventions
Intervention type(s): Other
Intervention description(s): Simulated hypovolemia by applied suction to lower extremities to cause venous pooling.
Other intervention name(s): Lower body negative pressure
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Influence of Facebook Ads on Food Choice
Condition: Food Choices
Study type: Interventional

Summary: 
      This is a randomized trial to examine the influence of race-congruent food marketing on
      social media among Black and White adolescents.
    

Detailed description: 
      The overall objective of our three studies is to identify the extent to which exposure to
      Facebook food ads increases the number of calories purchased and consumed by Black and White
      adolescents. Guided by strong preliminary data, the study team will test three aims: 1)To
      evaluate the extent to which exposure to racially congruent vs. incongruent Facebook food ads
      causes Black vs. White adolescents to purchase more calories for a snack; 2)To determine the
      extent to which exposure to many vs. few "likes" on Facebook food ads causes Black and White
      adolescents to purchase more calories for a snack; and 3)To test the degree to which visual
      attention to unhealthy foods, racially congruent people, and/or "likes" in Facebook ads
      explains the relationship between ad exposure and calorie intake.
    

Intervention name(s): Racially Congruent Ads; Racially Incongruent Ads
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Facebook food ads that are racially congruent.; Facebook food ads that are racially incongruent.
Allocation: Randomized
Intervention model: Factorial Assignment
Intervention model description: The intervention is exposure to Facebook food ads that are either race congruent or race incongruent, and that have varying numbers of likes.
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
The Effect of Morphine on Prasugrel Absorption in STEMI Patients
Condition: Cardiovascular Disease
MeSH terms: Cardiovascular Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      Heart Attacks are a major cause of death in this country. When patients have a heart attack,
      they are treated with anti-clotting drugs, one of which is a drug called Prasugrel. It is
      important that Prasugrel starts to work as quickly as possible following a heart attack. As
      many patients who have a heart attack experience excruciating pain, they are often given
      morphine (a strong painkiller) by the Ambulance crew. We think that morphine may affect how
      Prasugrel is absorbed from the stomach and may delay how quickly it starts to work. We intend
      to study the effect of morphine on the absorption of Prasugrel.
    


Intervention name(s): morphine; saline
Intervention type(s): Drug; Drug
Intervention description(s): 2.5mg of morphine will be given post Prasugrel administration with a further 2.5mg 5 minutes later; 2.5ml of saline will be given post Prasugrel followed by a further 2.5ml as a comparator for the morphine
Intervention MeSH terms: Morphine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Effects of Dry Needling on Muscle Function in Patients With Hip Osteoarthritis
Condition: Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Hip
Study type: Interventional

Summary: 
      The aim of this study was to assess the effects of dry needling technique on muscle strength
      and muscle length in patients with hip osteoarthritis at short term.
    


Intervention name(s): Dry needling; Sham dry needling
Intervention type(s): Other; Other
Intervention description(s): Dry needling is a skilled intervention that uses a thin filiform needle to penetrate the skin and stimulate underlying myofascial trigger points, muscular, and connective tissues for the management of neuromusculoskeletal pain and movement impairments; Sham Dry needling use a non-penetrating acupuncture needle
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
A Community-based Depression Screening Intervention for Middle-aged Suicide
Condition: Suicide
MeSH terms: Suicide
Study type: Interventional

Summary: 
      The purpose of this study is to examine the effectiveness of a community-based
      depression-screening program for suicide prevention among middle-aged adults, the
      investigators conducted a quasi-experimental intervention study, using a parallel cluster
      design with communities at municipal level as the unit of allocation and individuals as the
      unit of analysis.
    

Detailed description: 
      Suicide is a major cause of premature death, particularly among middle-aged adults, in the
      majority of Western and Asian countries. A strong association of suicide and depression often
      indicates the necessity of a high-risk approach for suicide prevention. Improvements in
      identification and treatment can lead to better depression outcomes and suicide prevention.
      The investigators hypothesize that a 4-year community-based intervention, consisting of
      universal depression screening and subsequent care support in the target areas and health
      education programs, would result in reduced suicide rates among the middle-aged adult
      population in areas with a high suicide rate.
    

Intervention name(s): Multi-level suicide prevention programs; Suicide prevention program as usual
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The intervention included both screening and educational components. The screening component invited residents aged 36-64 years to participate in a two-step screening program. In the initial screening, a self-report questionnaire were mailed to all of those residents in the priority districts with a past high suicide rate. The second stage was conducted for the participants who screened positive though a semi-structural interview. Based on the results, participants who were diagnosed with a major depressive episode were provided with a referral to a psychiatry and support for treatment adherence. Written feedback on the screening results was mailed to all respondents. The educational component was implemented through workshops open to the general public (3 times every year) and local public newsletters (twice every year) designed to improve access and adherence to treatment and to reduce stigma associated with suicide and depression.; Usual mental health program (not including depression screening among middle-aged)
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: suicide; prevention
A Randomized Clinical Trial To Study Losartan On Endothelial Dysfunction and Insulin Resistance In Obese Patients
Condition: Obesity; Hypertension; Hyperglycemia
MeSH terms: Insulin Resistance; Hyperglycemia
Study type: Interventional
Phase: Phase 4

Summary: 
      The main purposes of this study are to find out if the study drug losartan (Cozaar) or
      placebo ("sugar pill") has an effect on insulin sensitivity (how your body responds to
      insulin) and to measure the effect of the study drug losartan or placebo on how the arteries
      in your arm dilate (enlarge to carry more blood).

      We hope to learn if taking losartan changes the amount of certain proteins in the blood that
      effect blood vessel function.

      Losartan is approved by the US FDA to treat high blood pressure. It will take approximately 4
      months for you to complete this study.
    


Intervention name(s): losartan; Placebo control
Intervention type(s): Drug; Drug
Intervention description(s): losartan 100 mg tablets 1 tab po QD; Placebo 1 po QD
Other intervention name(s): Cozaar
Intervention MeSH terms: Losartan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Impaired Fasting Glucose FPG >100-<126 mg/dL
The Role of Peptide YY (PYY)Infusions in Inhibiting Food Intake.
Condition: Obesity
Study type: Interventional

Summary: 
      The aim of the study is to compare fasting and postprandial PYY levels between
      overweight/obese and lean subjects during and after an infusion of saline, PYY1-36 or PYY3-36
      and to evaluate the efects on appetite, energy intake and energy expenditure.
    

Detailed description: 
      The study is a randomised dobbelblinded placebo controlled study with 24 male subjects ( 12
      lean and 12 overweight/obese subjects). VAS scores are used to assess appetite and two ad
      libitum meals are served in the hours following the infusion. Energy expenditure is measured
      by ventilated hood system and blood is sampled during part of the study day.
    

Intervention name(s): Peptide YY infusion
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single
Primary purpose: Treatment
Efficacy and Safety Clinical Trial of Tenoten for Children Liquid Dosage Form Therapy in Infants With Sequelae of Perinatal Brain Injury
Condition: Sequelae of Perinatal Brain Injury
MeSH terms: Brain Injuries; Wounds and Injuries
Study type: Interventional
Phase: Phase 3

Summary: 
      Purpose of the study:

        -  To assess the clinical efficacy of Tenoten for children liquid dosage form therapy (10
           oral drops per day for 12 weeks) in Infants with Sequelae of Perinatal Brain Injury
           (mild-to-moderate cerebral hypoxia-ischaemia and/or mild-to-moderate intracranial
           haemorrhage).

        -  To assess the safety of Tenoten for children liquid dosage form therapy (10 oral drops
           per day for 12 weeks) in Infants with Sequelae of Perinatal Brain Injury
           (mild-to-moderate cerebral hypoxia-ischaemia and/or mild-to-moderate intracranial
           haemorrhage).
    


Intervention name(s): Tenoten for children; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral. 10 drops daily, at the same time in the morning, 15 minutes before feeding.; Oral. 10 drops daily, at the same time in the morning, 15 minutes before feeding.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effect of CYP2C9*3 Polymorphism on Ibuprofen in Pakistani Population
Condition: Healthy Volunteers
Study type: Observational

Summary: 
      The goal of this Observational study was to identify the effect of CYP2C9 gene polymorphism
      in the Pakistani population. The main question it aims to answer were:

        -  to evaluate the effect of this genetic polymorphism on the clinical efficacy of
           Ibuprofen

        -  to evaluate the effect of this genetic polymorphism on the clinical tolerability of
           Ibuprofen Participants were prescribed Ibuprofen after molar tooth extraction.
    

Detailed description: 
      The goal of this observational study was to identify the effect of CYP2C9*3 gene polymorphism
      in the Pakistani population, due to the high prevalence of this variant in the Pakistani
      Population

      The main question it aims to answer were:

        -  to evaluate the effect of this genetic polymorphism on the clinical efficacy of
           Ibuprofen

        -  to evaluate the effect of this genetic polymorphism on the clinical tolerability of
           Ibuprofen Participants were prescribed Ibuprofen after molar tooth extraction.

      The blood samples of the participants were taken and further genotyping was performed using
      conventional tetraARMS PCR. The results were visualized by gel electrophoresis.
    

Intervention name(s): Ibuprofen
Intervention type(s): Genetic
Intervention description(s): Ibuprofen 400mg three times a day for three days
Intervention MeSH terms: Ibuprofen
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Individuals who were advised for molar tooth extractions based on orthodontic, periodontal,
        and endodontic indications
      
Biospecimen description: 
      Venous blood was withdrawn, and DNA extraction was performed using Chelex method.