bioihbjkbjnl/mcl2 huggingface dataset:
The CHAPTER II Study - Congenital Heart Adolescents Participating in Transition Evaluation Research
Condition: Congenital Heart Disease
MeSH terms: Heart Diseases; Heart Defects, Congenital
Study type: Interventional

Summary: 
      Transition is the planned movement of teens with chronic conditions from child-centered to
      adult-oriented healthcare. National bodies have published detailed guidelines about the
      importance of helping teens move to adult healthcare. However, there is no research regarding
      how to best organize and deliver Congenital Heart Disease (CHD) transition programs. Data is
      urgently needed. Therefore, the aim of this program is to develop research evidence that will
      better prepare health care providers to improve how they can help adolescents with
      transition.

      This project will determine whether a nurse-led transition intervention program is better at
      preparing teens with CHD to independently manage their medical care, compared to the care
      that is currently provided. The most important finding of this study will be whether or not
      these teens subsequently attend the adult cardiology clinic that specializes in CHD problems,
      and the timing of when they attend.

      Hypothesis: A transition intervention in combination with usual care, improved time to first
      Adult Congenital Heart Disease (ACHD) clinic attendance compared to usual care alone.
    


Intervention name(s): Educational; Self management
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The first interaction will happen at study enrolment and will be educational in nature.
Following the session, the nurse will follow up with the participant to discuss any questions.; The second interaction will take place 2 months after enrollment and will focus on self management and communication skills.
Following the session, the nurse will follow up with the participant to discuss any questions.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Transition from pediatric to adult clinical care
Prevention of High Altitude Pulmonary Edema
Condition: High Altitude Pulmonary Edema
MeSH terms: Altitude Sickness; Pulmonary Edema; Hypertension, Pulmonary; Edema
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      A double-blind placebo controlled study

        -  To compare the effect of tadalafil and dexamethasone versus placebo on Ppa and pulmonary
           edema formation in subjects susceptible to HAPE.

        -  To investigate the effect of dexamethasone on alveolar fluid clearance, as assessed by
           measurement of the nasal potential difference, and prevention of HAPE.

        -  To investigate the effect of the tadalafil and dexamethasone versus placebo on the
           dynamic CBF autoregulation properties and on the development of AMS in HAPE susceptible
           subjects.
    


Intervention name(s): dexamethasone 8 mg bid; tadalafil 10mg bid
Intervention type(s): Drug; Drug
Intervention MeSH terms: Dexamethasone; Tadalafil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Diet and Sleep Monitoring
Condition: Sleep; Diet Modification
Study type: Interventional

Summary: 
      This study will investigate the effect of two dietary patterns on sleep outcomes and measures
      of reported appetite. Participants will be given two different diets on two separate stays.
    

Detailed description: 
      Normal sleep consists of alternating periods of non-rapid eye movement (NREM) and rapid eye
      movement (REM) sleep. The deeper stages of NREM sleep are also known as slow-wave sleep
      (SWS). Genetic and environmental factors, such as age, gender, race, socioeconomic status and
      others contribute to high inter-individual variability in sleep quality.

      Current evidence from epidemiologic, clinical and experimental studies support a strong
      relationship between insufficient sleep and increased risk for obesity. A reciprocal
      connection between sleep and energy metabolism may exist between diet and sleep.

      It is also well known that diet greatly influences body weight and metabolic health. Numerous
      disease risk factors are known to be associated with dietary patters consisting low fiber,
      high saturated fat, and added sugar, but the effects of diet on sleep quality remains
      unknown.

      A small group of studies have indicated an effect of diet on sleep quality (assessed
      objectively by polysomnography [PSG]) under controlled laboratory conditions. However, none
      have experimentally tested sleep and appetite outcomes under different dietary patterns
      matched for macronutrients.

      The overall objective of this study is to compare the effects of consumption of unhealthy
      meals with low fiber, high saturated fat, and high added sugar content i.e. simulated fast
      food diet [SFF] to healthy meals with high fiber, low saturated fat, and low added sugar
      content i.e. healthy diet. We hypothesize that a healthy diet (as recommended by the Dietary
      Guidelines Advisory Committee and the American Heart Association) compared to SFF diet will
      promote better sleep quality (as assessed by PSG) reflected by higher sleep efficiency,
      increased SWS and increased REM sleep and other improved sleep variables. We will also
      evaluate subjective appetite, mood and sleepiness as secondary outcomes.
    

Intervention name(s): Diet Quality
Intervention type(s): Other
Intervention description(s): Diets matched for calorie intake and macronutrient distribution but differing by overall diet quality will be provided in a random order, cross-over design study.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Other
Keywords: sleep; macronutrients; dietary patterns; sleep quality; diet quality; polysomnography; appetite; mood; hunger
Effects of Airway Conditioning Devices on Ventilator Associated Pneumonia:a Randomized Clinical Trial
Condition: Acute Lung Injury
MeSH terms: Pneumonia; Pneumonia, Ventilator-Associated; Lung Injury; Acute Lung Injury
Study type: Interventional

Summary: 
      The main hypothesis are:

        1. Passive and Active-Passive airway conditioning devices reduce the incidence of
           ventilator associated pneumonia

        2. Active-Passive airway conditioning devices reduce the incidence of endotracheal tube
           obstruction

        3. Nurses' workload is reduced with Passive and Active-Passive airway conditioning devices
    

Detailed description: 
      For all Three lines of the study we record Clinical Pulmonary Infection score and Airways
      Care Score, SOFA (Sequential Organ Failure Assessment), sedation strategy, Glasgow Coma Score
      and clinical data.
    

Intervention name(s): Airway Conditioning
Intervention type(s): Device
Intervention description(s): Each Passive device will be changed daily. When using Active and Passive devices as well as Active-Passive devices the ventilatory circuit will be changed every 7 days.
Other intervention name(s): Passive: Hygrobac; Active-Passive: Hygrovent Gold; Hot Water: Tyco HC 2000 heated wire
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Hot water humidifier, Passive heat and moisture exchangers
Study of Evaluation Indexes for Antibody Production in Sera After Immunization
Condition: Aged
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study is to evaluate analytical methods such as ELISA and OPKA that measure
      the activity of vaccine-induced pneumococcal antibodies. After validation of ELISA and OPKA,
      pneumococcal antibodies were measured by ELISA and OPKA in paired samples before and after
      immunization (pneumococcal PS vaccine) in children, adults and elderly.
    

Detailed description: 
      To evaluate the immune response to the pneumococcal polysaccharide vaccine in the elderly,
      samples from children, young adults and elderly were obtained before and one month after
      vaccination. The quantitative and qualitative response to the vaccine were measured by the
      ELISA and opsonophagocytic killing assay for eight vaccine type serotypes (4, 6B, 9V, 14,
      18C, 19A, 19F, 23F) and one vaccine-related serotype (6A).
    

Intervention name(s): pneumococcal polysaccharide vaccine
Intervention type(s): Biological
Intervention description(s): single intramuscular injection of 0.5 ml Pneumo23® (Sanofi-Aventis, Lyon France)
Other intervention name(s): Pneumo23®
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Pneumococcal Vaccine; Aged
An Effectiveness and Safety Study of Inhaled JNJ 49095397 (RV568) in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the effectiveness and safety of JNJ 49095397 in
      participants with symptomatic moderate to severe chronic obstructive pulmonary disease
      (COPD).
    

Detailed description: 
      This is a randomized (the study medication is assigned by chance), double-blind (neither
      physician nor participant knows the treatment that the participant receives),
      placebo-controlled (an inactive substance that is compared with a medication to test whether
      the medication has a real effect in a clinical study), multicenter, parallel-group (each
      group of participants will be treated at the same time) study. Approximately 200 participants
      will be randomly assigned to JNJ 49095397 or placebo in the ratio 1:1. The study consists of
      3 phases: screening (3 weeks), double-blind treatment (12 weeks), and follow up (4 weeks).
      Safety evaluations will include assessment of adverse events, vital signs, physical
      examination, electrocardiograms, and clinical laboratory tests which will be monitored
      throughout the study. The total duration of the study for each participant will be
      approximately 19 weeks.
    

Intervention name(s): JNJ 49095397; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): JNJ 49095397 400 microgram will be inhaled by participants once daily by using a dry powder inhaler for 12 weeks.; Placebo will be inhaled by participants once daily by using a dry powder inhaler for 12 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Chronic Obstructive Pulmonary Disease; JNJ 49095397; RV568; Forced expiratory volume in one second; FEV1
The Effect of Bitter, Umami and Sweet Tastants on Food Intake
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      Rationale: The appearance of tastants in the small intestine can result in the activation of
      a negative feedback mechanism from different parts of the intestine to the stomach, the small
      intestine and to the central nervous system. These processes inhibit food processing,
      appetite sensations and food intake, and furthermore they increase feelings of satiety and
      satiation. We will investigate the effects of intraduodenal infusion of quinine 75mg
      (bitter), rebaudioside A 540mg (sweet), monosodium glutamate 2g (umami), a combination of
      these tastants (quinine, rebaudioside A, monosodium glutamate) and placebo (5 test days in
      total) on ad libitum food intake, satiation and in vivo release of the gut satiety peptides
      CCK and GLP-1.

      Study design: To assess the effect of intraduodenal infusion of single ingredients and a
      combination of tastants (bitter, umami and sweet) on ad libitum food intake.

      Secondary Objective(s):

        1. To investigate the effect of intraduodenal delivery of a combination of tastants on
           satiation.

        2. To assess the effect of intraduodenal delivery of a combination of tastants on
           gastrointestinal hormone release.

        3. To assess the effects of the tastants quinine, rebaudioside A and monosodium glutamate
           on the parameters as mentioned under the primary objective, and under secondary
           objectives 1 and 2.

        4. To compare the effects, as mentioned under the primary objective, and under secondary
           objectives 1 and 2, of the combination of tastants to those of the three single tastants
           quinine, rebaudioside A and monosodium glutamate.
    


Intervention name(s): umami; bitter; sweet
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): intraduodenal infusion of umami tastant; intraduodenal infusion of bitter tastant; intraduodenal infusion of sweet tastant
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: food intake; tastants; obesity
Perspectives on Prescribing Hormonal Contraception Among Rural New Mexicans
Condition: Contraception
Study type: Observational

Summary: 
      The goal of this study is to identify the thoughts and perceptions of pharmacy access to
      hormonal contraception among rural women and pharmacists. This will be key in order to
      address concerns or perceived barriers in order to inform the implementation of this program.
    

Detailed description: 
      There are no studies examining New Mexico pharmacists' interest in prescribing hormonal
      contraceptives or rural New Mexican women's support for pharmacist prescribed hormonal
      contraceptives. However, some states where pharmacists already prescribe contraception have
      experienced difficulties in implementing the education, infrastructure, and financial support
      necessary to provide hormonal contraception in the community pharmacy setting. Nationwide,
      68% of women reported that they would utilize pharmacist prescribed hormonal contraception
      and cited benefits such as convenient hours and locations of pharmacies. The goal of this
      study is to identify the thoughts and perceptions of pharmacy access to hormonal
      contraception among rural women and pharmacists. This will be key in order to address
      concerns or perceived barriers in order to inform the implementation of this program.
    

Intervention name(s): Pharmacists & women's perspectives on pharmacist prescribed hormonal contraception
Intervention type(s): Other
Intervention description(s): The goal of this study is to identify the thoughts and perceptions of pharmacy access to hormonal contraception among rural women and pharmacists. This will be key in order to address concerns or perceived barriers in order to inform the implementation of this program.
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Our study is qualitative and not meant to capture a representative sample of the state's
        population, but rather capture a diverse array of opinions regarding hormonal
        contraception.
      
Keywords: Pharmacists; Prescriptions
The Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of HEC88473 in Healthy Subjects
Condition: Non-alcoholic Steatohepatitis
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      A Phase 1, double blind, placebo controlled, single and multiple ascending dose, safety,
      tolerability, pharmacokinetic, and pharmacodynamic study of HEC88473 in healthy subjects
    

Detailed description: 
      This is the first time HEC88473 will be administered to humans. The aim of this study is to
      obtain safety, tolerability, PK, PD, and immunogenicity data of HEC88473 SC administration as
      single and multiple ascending doses in healthy subjects.
    

Intervention name(s): HEC88473 injection; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): HEC88473 will be provided as a 17 mg/mL solution and will be administered by subcutaneous injection in the abdomen; Placebo will be administered by subcutaneous injection in the abdomen
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
LEPU Renal Denervation System for Resistant Hypertension
Condition: Hypertension; Cardiovascular Diseases; Vascular Diseases
MeSH terms: Hypertension; Cardiovascular Diseases; Vascular Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose was to evaluate 6-month outcomes of renal denervation(RDN) for the treatment of
      resistant hypertension in Chinese patients in a prospective cohort study.
    

Detailed description: 
      Currently, considerable data on RDN have been obtained from Western populations, while the
      clinical outcomes of RDN in East Asian populations are seldom reported. Therefore, the
      purpose was to evaluate 6-month outcomes of RDN for the treatment of resistant hypertension
      in Chinese patients.In a prospective single-center cohort study, 50 Chinese patients with
      resistant hypertension would be recruited to undergo RDN by LEPU Renal denervation system,
      which was similar to Symplicity the Symplicity renal-denervation system (Medtronic). The
      primary effectiveness endpoint was change in systolic and diastolic blood pressure at six
      months as measured by office-based blood pressure assessment and 24-hour ambulatory blood
      pressure monitoring following therapeutic renal denervation compared to baseline. The primary
      safety endpoint was the incidence of Major Adverse Event (MAE) through 6 months , including
      severe renal artery dissection/stenosis(>60%) that required stenting or surgery,
      cerebrovascular accident, myocardial infarction, death.
    

Intervention name(s): LEPU Renal Denervation System
Intervention type(s): Device
Intervention description(s): LEPU Renal denervation system was similar to Symplicity Catheter System (Medtronic Inc.)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Bioequivalence Study of Montelukast From Asmakast 10mg Tabs (Sandoz, Egypt) & Singulair 10mg Tabs (Merck)
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Comparative randomized, single dose, two-way crossover open-label study to determine the
      bioequivalence of Montelukast fromAsmakast10 mg tablets (Man. by Minapharm Egypt for Novartis
      Pharma Egypt S.A.E (Sandoz), Egypt) and Singulair10 mg tablets (Produced by Global Napi
      Pharmaceuticals, Egypt under license from: Merck & Co. Inc., USA) after a single oral dose
      administration of each to healthy adults under fasting conditions.
    

Detailed description: 
      19 blood samples will be drawn in each period. The total volume of blood will not exceed 200
      ml throughout the whole study.0.00 (pre-dose), 0.25, 0.50, 0.75, 1.00, 1.25, 1.50, 2.00,2.50,
      3.00,3.50, 4.00, 4.50, 5.00, 6.00, 8.00, 10.00, 12.00, and 24.00 hours post dose. Primary
      Pharmacokinetic Parameters: Cmax, AUC0→t and AUC0→∞ Secondary Pharmacokinetic Parameters: Ke,
      tmax and t1/2e. ANOVA using 5% significance level for transformed (with the 90% confidence
      intervals) and untransformed data of Cmax, AUC0→t and AUC0→∞ and for untransformed data of
      Ke, tmax and t1/2e. The confidence intervals of logarithmically transformed Test/Reference
      ratios for Cmax, AUC0→t and AUC0→∞ to be within 80.00-125.00%.

      A comprehensive final report will be issued upon the completion of the study.
    

Intervention name(s): Asmakast; Singulair
Intervention type(s): Drug; Drug
Intervention description(s): 1 tablet contains 10 mg of montelukast; 1 tablet contains 10 mg of montelukast
Other intervention name(s): Singulair
Intervention MeSH terms: Montelukast
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Impact of Interpretation Bias Modification Training on Anger and Reactive Aggression
Condition: Anger
MeSH terms: Aggression
Study type: Interventional

Summary: 
      Difficulties with anger control are reported in a number of psychological conditions and are
      associated with social problems, such as dating violence and workplace violence. High trait
      anger is a personality construct characterized by elevations in the frequency, duration, and
      intensity of anger episodes. However, the cognitive processes contributing to high trait
      anger are still poorly understood. This study will examine the effectiveness of a
      computer-based cognitive bias modification (CBM) program designed to target hostile
      interpretations associated with high trait anger.
    

Detailed description: 
      High trait anger is a personality construct characterized by elevations in the frequency,
      duration, and intensity of anger episodes. According to the Integrative Cognitive Model (ICM)
      of anger, three cognitive processes jointly contribute to an individual's level of trait
      anger and reactive aggression: hostile attributions, ruminative attention, and effortful
      control processes. Specifically, individuals high in trait anger are more prone to interpret
      ambiguous situations as hostile; are more likely to ruminate about anger-related events; and
      have a more limited capacity to employ control processes when they become angry.

      One means of evaluating unconscious biases that has become increasingly popular is cognitive
      bias modification (CBM). CBM programs are computerized training paradigms, which aim to train
      more adaptive cognitive biases by repeatedly exposing participants to an experimental
      contingency between an emotional stimulus and a response.Previous researchers have begun to
      investigate the impact of CBMs targeting cognitive control and hostile attribution bias in
      relation to anger. However, these studies have been conducted exclusively in samples
      reporting low trait anger.

      This study will examine the effectiveness of a short-term interpretation bias modification
      program (CBM-I) on hostile attribution biases and reactive aggression in a sample of
      undergraduate students eporting high trait anger.
    

Intervention name(s): Interpretation Bias Modification; Control Training Program
Intervention type(s): Behavioral; Behavioral
Intervention description(s): A computer based interpretation bias modification program that aims to reinforce neutral interpretations of ambiguous social situations.; A sham training program that is similar in design and delivery to the experimental training condition.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Reactive aggression; High trait anger; Cognitive bias modification; Interpretation bias modification
A Double-blind Study of KRN321 for the Treatment of Anemia in Cancer Patients
Condition: Anemia
MeSH terms: Anemia
Study type: Interventional
Phase: Phase 3

Summary: 
      To compare the effectiveness of KRN321 to placebo in the treatment of anemia in cancer
      patients receiving multi cycle platinum-containing chemotherapy
    


Intervention name(s): darbepoetin alfa
Intervention type(s): Drug
Intervention MeSH terms: Darbepoetin alfa
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: darbepoetin alfa; anemia; cancer patients; platinum containing chemotherapy