bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Compare Pharmacokinetic and Safety of TRS003 to China-approved Bevacizumab and US-licensed Avastin®
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a 12-week, randomized, double-blind, single-dose pharmacokinetic (PK) study.
      Approximately 114 healthy male participants (screening occurred within 28 days prior to
      dosing) will be randomized 1:1:1 to either TRS003, China-approved bevacizumab, and
      US-licensed Avastin® groups. Study drug will be dispensed as a single 3 mg/kg dose for
      intravenous infusion within 90 minutes. PK and immunogenicity samples will be collected and
      safety will be assessed. The primary objective of this study was to demonstrate
      pharmacokinetic similarity between TRS003, China-approved bevacizumab and US-licensed
      Avastin®, as measured by AUC0-inf in healthy male participants after a single 3 mg/kg dose.
    

Detailed description: 
      The primary assessment of PK similarity will be based upon a 90 percentage confidence
      interval (CI) for the ratio of the geometric means (TRS003, China-approved bevacizumab and
      US-licensed Avastin®) for AUC0-inf on PK analysis set. If the 90 percentage CI of the ratio
      of the geometric means for AUC0-inf is within the range of 80-125 percentage, then PK
      similarity will be concluded. Secondary PK parameters such as but not limited to Cmax,
      AUClast will be analyzed using the same statistical approach. A nonparametric approach, for
      example, Wilcoxon signed-rank test, will be taken to evaluate parameters such as t1/2.
      Exploratory analyses may be performed for other PK parameters as deemed appropriate. All
      adverse events (AEs) will be listed and summarized using descriptive methodology. The
      incidence of AEs for each treatment will be presented by severity and association with the
      study drugs. Clinical laboratory parameters, vital signs, and electrocardiogram (ECG)
      parameters will be listed and summarized using descriptive statistics. The number and
      percentage of participants testing positive for anti-drug antibodies (ADAs) will be
      summarized by treatment and time point.
    

Intervention name(s): TRS003; China-approved Bevacizumab; US-licensed Avastin
Intervention type(s): Biological; Biological; Biological
Intervention description(s): 25mg/mL (4 mL/vial) Injection，Single dose of 3mg/kg Intravenous infusion for 90 minutes; 25mg/mL (4 mL/vial) Injection，Single dose of 3mg/kg Intravenous infusion for 90 minutes; 25mg/mL (4 mL/vial) Injection，Single dose of 3mg/kg Intravenous infusion for 90 minutes
Intervention MeSH terms: Bevacizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Safety and Immunogenicity of Sequential Pneumococcal Immunization in Preschool Asthmatics
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 4

Summary: 
      Asthma is a major health problem in preschool children. Infections by pneumococci a the most
      frequent cause of airway infections, which tend to cause worsening of asthma. Vaccination
      against pneumococci is recommended by scientific boards and the medical community, in order
      to reduce the burden of disease. Data on the immunogenicity and safety of pneumococcal
      immunization in preschool asthmatics are scarce.
    

Detailed description: 
      Respiratory infections are major triggers of exacerbations in preschool asthma. Many
      countries' guidelines recommend immunization against pneumococci for patients suffering from
      chronic airway disease. Also the interval between priming and booster is a matter of debate.

      We immunize a large group of preschool asthmatics (2-5 years old) sequentially: one dose of
      seven-valent pneumococcal conjugate vaccine (PCV-7) followed by a single dose of 23-valent
      pneumococcal polysaccharide vaccine (PPV-23). We randomly assign half of the vaccinees to
      receive PPV-23 eight weeks after PCV-7 (group A), and the rest to a 10-month interval (group
      B). Pneumococcal antibody concentrations to serotype 4, 5, 6B, 7, 9V, 14, 18c, 19F, and 23F
      are determined initially, after two, and 12 months after PCV-7. Local and systemic reactions
      to each vaccine are recorded.
    

Intervention name(s): prevenar; pneumovax
Intervention type(s): Biological; Biological
Intervention description(s): 7-valent pneumococcal conjugate vaccine; 23 valent pneumococcal polysaccharide vaccine
Other intervention name(s): Prevnar, PCV-7; pneumopur, PPV-23
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: preschool asthma; sequential pneumococcal immunization; immunogenicity; safety
18F-AV-1451 High Resolution Autopsy Study
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is designed to examine the relationship between imaging results detected on a
      18F-AV-1451 PET scan and pathology found at autopsy within six months of imaging.
    


Intervention name(s): 18F-AV-1451
Intervention type(s): Drug
Intervention description(s): Subjects will receive a single IV bolus injection of 370 megabecquerel (MBq)(10 millicurie [mCi]) of 18F-AV-1451.
Other intervention name(s): [F-18]T807
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Physical Activity and Food Intake Interaction: Effect of Weight Loss in Obese Adolescent
Condition: Obesity
MeSH terms: Weight Loss
Study type: Interventional

Summary: 
      In obese adolescents, energy expenditure (EE) of chronic high intensity muscular exercise (>
      70% VO2max) conducted one hour before a meal causes an anorectic effect at lunch and dinner
      the same day. The effect on food intake of the distribution of this exercise into two
      sessions during 24h remains to be determined. In addition, a multidisciplinary load of
      obesity generates a loss of body weight in the short term, which we do not know the effects
      on energy balance. To our knowledge, the impact of weight loss on the anorectic effect of
      muscle exercise is unknown.
    

Detailed description: 
      Two measuring sequences will be carried out before (M0) and after 4 months (M4) of a
      multidisciplinary treatment program of four months. Each sequence will have three days: a
      "sedentary" day (SED) and two days "exercise" (EX). During the exercise day "EX1", a
      continuous intense exercise will be conducted for 40 min at 70% VO2max of subjects. During
      the second day exercise "EX2" teenage realize two exercise representing the same DE as EX1 in
      the morning (50% ED) and late afternoon (50% ED). The multidisciplinary management program
      (without energy restriction) controlled by institution consists of nutrition education,
      physical activity and therapeutic education. The exercise program will involve the activity
      sessions controlled and supervised by a sports educator and interactive sessions using a
      scientifically validated physical activity program (Biomouv®).
    

Intervention name(s): Physical activity
Intervention type(s): Behavioral
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Obesity; Appetite regulation; Insulin sensitivity; Adolescents; Exercise
Body Composition, Dietary Behaviors, Energy Expenditure and Physical Activity Among Moroccan Schoolchildren and Adolescents
Condition: Body Composition; Physical Activity
Study type: Observational

Summary: 
      Considering the increasing public health concern the obesity in Morocco, the aim of the
      present study was to use isotope techniques to assess body fat, total energy expenditure and
      physical activity to inform design and improve interventions for the prevention and control
      of obesity and related health risks such as diabetes and elevated blood pressure among
      children and adolescents. Specific objectives of the trial: 1. Determine the extent of
      obesity and physical activity levels in children and adolescents to design effective
      interventions in the school setting. 2.Propose alternative field based techniques for
      assessing body composition and physical activity that could be used in largescale situation
      assessments and in assessing interventions to address obesity and risk related health care. *
      For body composition: BMI z-score, waist circumference, waist measurement at height. * For
      physical activity: Questionnaire, Accelerometers 3. To identify factors contributing to the
      development of obesity and related health risks in schoolchildren and adolescents. 4.
      Collaborate with stakeholders (government, schools and / or colleges, communities and
      development partners) in designing interventions to address obesity and health risks. 5. To
      recommend to stakeholders the most effective interventions in schools to prevent and combat
      obesity and health risks in children and adolescents.
    


Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Moroccan children and adolescents recruited from public urban schools.
      
Keywords: Obesity; Body composition; energy expenditure; sedentarity; dietary behaviors
Study to Investigate the Regional Drug Absorption of KUC-7483 CL Administered Via an Enterion™ Capsule Compared to an Immediate Release Formulation in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to determine and compare the absorption of KUC 7483 CL from different regions of the GI
      tract with the immediate release formulation and to compare the absorption of particulate
      versus solution formulations from the ascending colon
    


Intervention name(s): KUC 7483 CL, immediate release tablet; KUC 7483 CL, particulate formulation; KUC 7483 CL, solution formulation; Enterion™ capsule
Intervention type(s): Drug; Drug; Drug; Device
Intervention MeSH terms: p-Hydroxyamphetamine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Quantifying Gait Alteration in Multiple Sclerosis Using a Wearable Device
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Observational

Summary: 
      Gait alteration is frequent in MS and limitation in walking ability is a major concern in MS
      patients. The development of wearable device offers the opportunity to collect data during
      daily activity including walking.
    

Detailed description: 
      Umanit and LMJ (Nantes university) has developed a device call eMSgait to assess walking
      ability in MS patients individuals (eg MS patients). This device consists in a commercialized
      IMU sensor (MetaMotionR Sensor, Mbientilab) worn at the right hip, a smartphone app and
      dedicated algorithm/mathematical model to extract raw sensor data and calculate individual
      gait pattern (IGP). This IGP consists of a curve, based on quaternion and representing the
      rotation recorded by the IMU during an average gait cycle. Pursue first pilot work assessing
      information from IGP on gait alteration in MS.
    

Intervention name(s): Wearable sensor
Intervention type(s): Other
Intervention description(s): IMU sensor (as part of eMSGait device) worn at the hip during T25FW
Other intervention name(s): MetaMotionR Sensor, Mbientilab
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        MS patients cohort followed at Nantes university hospital
      
Keywords: Wearable sensor; Gait
Physical Activity, Exercise Capacity and Coronavirus Phobia of Adult Cystic Fibrosis Patients During COVID-19 Pandemic
Condition: Cystic Fibrosis
MeSH terms: COVID-19; Cystic Fibrosis; Fibrosis
Study type: Observational

Summary: 
      The purpose of this study was to evaluate physical activity, exercise capacity, quality of
      life, cognitive status level and coronavirus phobia level of adult cystic fibrosis patients
      and compare with the findings of healthy subjects with teleconference during COVID-19
      pandemic.
    

Detailed description: 
      This study will be participated adult with cystic fibrosis and healthy individuals.
      Demographic information of individuals will be recorded in online video conference. Physical
      activity, exercise capacity and cognitive function levels will be measured during video
      conferencing.Then, the physical activity level, coronavirus phobia and quality of life of the
      participants will be evaluated subjectively with questionnaires through the Google forms.
    

Intervention name(s): exercise capacity
Intervention type(s): Other
Intervention description(s): 3minute step test and 1minute sit to stand test used assessment of exercise capacity.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients and healthy individuals between 18-65 years old, who are diagnosed with cystic
        fibrosis will be included in the study.
Omphalitis Community Based Algorithm Validation Study
Condition: Omphalitis
Study type: Observational

Summary: 
      The objective of this study is to develop and test a simple community-based diagnostic
      algorithm for omphalitis in sub-Saharan Africa. To date, there has been no validated
      community-based algorithms developed and tested in the sub-Saharan context where the
      manifestations of omphalitis presentation may vary and diagnosis could be potentially more
      challenging in infants with darker skin color. Given the current attention to cord care at
      the global and national policy level, validated community-based algorithms will be needed to
      allow primary health workers to identify cord infections and reduce associated morbidity.

      After obtaining guardian informed consent, newborns aged 1-10 days presenting to the health
      facility for routine or sick visits will undergo two independent, parallel evaluations;
      first, by a community level worker and second, by a Zambian medical doctor (gold standard). A
      third independent assessment of a photo of the cord will be performed remotely by a
      board-certified pediatrician. Using the on-site clinician as the gold standard, the
      community-based algorithm and the photo assessment will be tested for concordance and the
      sensitivity and specificity of the algorithm will be generated. Likewise, the remote
      pictorial assessment will be compared to the gold standard to determine reliability of
      diagnosis from photographs alone.
    


Intervention name(s): Diagnostic Algorithm for Community Based Worker for Omphalitis
Intervention type(s): Procedure
Intervention description(s): After obtaining guardian informed written consent, newborns aged 1-10 days presenting to the health facility for routine or sick visits would undergo 2 independent, parallel evaluations; first, by a ZamCAT Field Monitor (community level worker from our existing study) and the second by a Zambian medical doctor (gold standard). A US board of pediatrics-certified pediatrician will perform a third independent assessment of a photo of the cord remotely. Using the on-site clinician as the gold standard, the community-based algorithm and the photo assessment will be tested for concordance and the sensitivity and specificity of the algorithm will be generated. Likewise, the remote pictorial assessment will be compared to the gold standard to determine reliability of diagnosis from photographs alone.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Neonate between day 1-10 of life presenting to Livingstone and Mazabuka district hospitals
        and community health centers in Southern Province, Zambia
      
Keywords: Omphalitis; Neonate; Zambia; Neonatal mortality; Umbilical cord infection
Increasing Exercise and Decreasing Sedentary Behavior Among Patients in a Cardiac Rehabilitation Clinic
Condition: Acute Coronary Syndrome; Heart Failure; Other Cardiac Conditions Among Cardiac Rehabilitation Participants
MeSH terms: Acute Coronary Syndrome
Study type: Interventional

Summary: 
      Cardiac rehabilitation patients often fail to exercise as prescribed on days they are not
      attending rehabilitation and there is a steep drop off in exercise following rehabilitation
      completion. Moreover, little is known about the amount of time that cardiac rehabilitation
      patients spend in sedentary behavior, which is associated with increased risk of
      cardiovascular morbidity and mortality, independent of time spent in exercise. This pilot
      study aims to test acceptability, feasibility, and preliminary efficacy of a smartphone
      application (B-MOBILE-CARDIAC) for increasing time spent in moderate-to-vigorous intensity
      physical activity accumulated in bouts of at least 10 minutes in duration (i.e. bout-related
      MVPA) and decrease time spent in sedentary behavior. Up to 32 patients will be recruited,
      enrolled, and randomized during the first 2 weeks of cardiac rehabilitation to either: 1)
      B-MOBILE-CARDIAC plus cardiac rehabilitation or 2) cardiac rehabilitation alone. Participants
      will complete 7 days of objective activity monitoring to measure daily minutes spent in
      bout-related MVPA and sedentary behavior (primary outcomes) at baseline, mid-rehabilitation
      (6 weeks), end of cardiac rehabilitation (12 weeks), and 4-week follow-up (16 weeks). At
      these same time points, participants will complete questionnaires assessing sedentary
      behavior, MVPA, exercise tolerance, health-related quality of life, mood, and affect. At
      baseline and end of cardiac rehabilitation participants will undergo a blood draw to measure
      cardiometabolic and inflammatory risk factors and complete a test of cognitive functioning.
      Feasibility and acceptability of the B-MOBILE-CARDIAC application will be assessed at the
      4-week follow-up.
    


Intervention name(s): B-MOBILE-CARDIAC smartphone application; Cardiac rehabilitation as usual
Intervention type(s): Other; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study of ARO-AAT in Normal Adult Volunteers
Condition: Alpha 1-Antitrypsin Deficiency
MeSH terms: Alpha 1-Antitrypsin Deficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and
      pharmacodynamics of single- and multiple-ascending doses of ARO-AAT in healthy adult
      volunteers.
    


Intervention name(s): ARO-AAT Injection; Sterile Normal Saline (0.9% NaCl)
Intervention type(s): Drug; Other
Intervention description(s): Single or multiple doses of ARO-AAT by subcutaneous (sc) injections; Calculated volume to match active comparator
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Efficacy of Zingiber Officinalis (Homoeopathic Medicine) in Treatment of Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 1

Summary: 
      Acne is one of the most common skin problems in teenagers and adolescents. There are many
      lesser known homoeopathic medicines which have been mentioned in the literature for treatment
      of acne but their potential has not been properly assessed /documented and therefore these
      medicines don't form a part of many prescriptions. As a part of this study, efficacy of
      Zingiber officinalis will be studied in the treatment of Acne vulgaris
    


Intervention name(s): Zingiber officinalis
Intervention type(s): Drug
Intervention description(s): To start with subjects will be prescribed Zingiber officinalis in 6 potency to be taken in form of pills 4 times a day for seven days. Dosage and frequency will be changed, if required, based on the condition of subject and their response according to homoeopathic principles.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acne Vulgaris; Homoeopathy; Zingiber officinalis
Personalized Back Rx Exercise Program as a Treatment for Discogenic Low Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      The prevalence and disability associated with discogenic low back pain are significant, and
      there is a general lack of widely accepted conservative treatments for the condition. A
      majority of previous studies that have assessed the efficacy of self-directed exercise-based
      rehabilitation programs did not include comprehensive metrics to confirm whether participants
      actually participated in the exercises prescribed. In this pilot study, the investigators
      hope to determine whether proxies of compliance with a daily, self-directed rehabilitation
      program for discogenic low back pain are correlated with participant-reported improvements in
      pain and function. The feasibility of a mobile interface designed to help patients with
      chronic low back pain track the daily management of their conditions will also be evaluated.
    


Intervention name(s): Back Rx program
Intervention type(s): Other
Intervention description(s): The Back Rx program can be viewed via a smartphone app.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
First-in-Human, Single- and Multiple-Ascending Dose and Food-Effect Study of BGB-23339 in Healthy Participants
Condition: Not Determined
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the safety, tolerability, and pharmacokinetics of BGB-23339 and food
      effects in healthy participants
    


Intervention name(s): BGB-23339; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered orally as a tablet; Administered orally as a tablet
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science