bioihbjkbjnl/mcl2 huggingface dataset:
Nutritional Strategies to Augment the Postprandial Muscle Protein Synthetic Response to the Ingestion of a Low Dose of Protein in Middle-aged Women
Condition: Aging
Study type: Interventional

Summary: 
      Using stable isotope methodology, investigators will determine the postabsorptive and
      postprandial muscle protein synthetic response in 60 female adults (Age 50-79, BMI: <30
      kg/m2) immediately after an acute bout of resistance exercise. Participants will be divided
      in to 5 groups of twelve women (n=12). Each group will receive a different protein beverage
      or placebo to consume following the resistance exercise training. Group 1 will consume a
      beverage consisting of whey protein; group 2 will consume whey protein supplemented with
      additional leucine; group 3 will consume whey protein supplemented with additional leucine
      and hydrolyzed whey peptides; group 4 will consume whey protein supplemented with additional
      leucine and citrulline; group 5 will just consume water. During the testing, blood and muscle
      samples will be collected.
    


Intervention name(s): Resistance Exercise; 14 g Whey protein; 6.6 g Whey protein + 1.25 g leucine; 4 g Whey protein + 1.25 g leucine + 2.6 g Whey peptides; 6.6 g Whey protein + 1.25 g leucine + 0.8 g Citrulline; Water control
Intervention type(s): Behavioral; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Other
Intervention description(s): Participants will perform unilateral leg extension exercise immediately prior to ingestion of the experimental beverage
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
The Transparent Safety Study of the 5 in 1 (DTwP-rHepB-Hib) Combination Vaccine Produced by the Indian Serine Institute in Children of Viet Nam Healthy From 6 to 12 Weeks of Age in a 3-dose Regimen, the Interval Between Doses is 4 Weeks
Condition: Diphtheria; Tetanus; Pertussis; Hepatitis B; Haemophilus Influenzae Type B
MeSH terms: Influenza, Human; Hepatitis B; Whooping Cough; Tetanus; Diphtheria; Hepatitis
Study type: Interventional

Summary: 
      The objective of this study is to evaluate safety and tolerability of Diphtheria, Tetanus,
      Pertussis, Hepatitis B and Haemophilus influenzae type b Conjugate Vaccine Adsorbed in
      Vietnamese infants aged 6-12 weeks. This is an open label, single group, bridging study.
    

Detailed description: 
      This will be an open label, single group, bridging study. Study subjects will be vaccinated
      with 3 (three) vaccine doses. The first vaccine will be administered intramuscularly starting
      at 6-12 weeks of age followed by two doses at four-week interval.

      This study was performed in strict accordance with Good Clinical Practice.
    

Intervention name(s): Study subjects will be vaccinated with 3 (three) vaccine doses. The first vaccine will be administered intramuscularly starting at 6-12 weeks of age followed by two doses at four-week interval
Intervention type(s): Biological
Intervention description(s): An openlabel, multicentric, bridging study to assess the safety of Diphtheria, Tetanus, Pertussis, Hepatitis B and Haemophilus influenzae type b Conjugate Vaccine (Adsorbed) manufactured by Serum Institute of India Pvt. Ltd in Vietnamese infants aged 6-12 weeks, given as a 3-dose regime, with 4 week intervals between the doses
Intervention MeSH terms: Vaccines
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Effect of Squeezable Bottle Nasal Irrigation Device in Children With Sinusitis
Condition: Sinusitis
MeSH terms: Sinusitis
Study type: Interventional

Summary: 
      The purpose of this study is to the effect of squeezable bottle nasal irrigation device with
      syringe in children with sinusitis in symptom score and satisfaction to nasal irrigation
    

Detailed description: 
      sinusitis is the one of common diseases in Thailand. Nasal irrigation has been used as an
      adjunctive treatment.In previous study shown that buffer hypertonic nasal irrigation have
      more effective to decrease symptom in patient sinonasal disease when compare to normal
      saline.Until now, there are no clear data comparing the effectiveness on sinonasal symptom of
      the various devices use in children with sinusitis. The purpose of this study was to compare
      the effect of squeezable bottle nasal irrigation device with syringe in children with
      sinusitis in symptom score and satisfaction to nasal irrigation.
    

Intervention name(s): squeezable bottle; syringe 20 ml
Intervention type(s): Device; Device
Intervention description(s): nasal irrigation twice daily for 2 weeks period; nasal irrigation twice daily for 2 weeks
Other intervention name(s): EEZNIS
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: nasal irrigation; sinusitis; children; buffered hypertonic saline; nasal irrigation device
ADAMTSL4 in Idiopathic Pulmonary Hypertension and CTEPH
Condition: Pulmonary Hypertension
MeSH terms: Hypertension, Pulmonary; Hypertension
Study type: Observational

Summary: 
      ADAMTSL4 (A disintegrin and metalloproteinase with thrombospondin motifs like) is a member of
      the ADAMTSL family. ADAMTSL4 is one of the family of 7 ADAMTS-Like proteins, themselves part
      of the Thrombospondin type 1 repeat (TSR) superfamily of proteins. These 7 proteins are
      divided into two distinct clades, of which ADAMTSL4 and ADAMTS-Like 6 form part of one clade,
      differing from ADAMTS-Like 1, ADAMTS-Like 3 and ADAMTS-Like 7 by lacking immunoglobulin
      repeat regions. ADAMTSL4 is widely expressed in brain, colon, heart, kidney, liver, lung,
      pancreas and spleen, yet, its precise role is unclear. in addition, ADAMTSL4 protein high
      expression to the medial layer of the arterial wall, and medial vascular smooth muscle cells
      specifically.
    

Detailed description: 
      The objectives of the present study aimed to confirm ADAMTSL4 levels in the proteomics
      between healthy control population and patients with IPAH，to analyze the expression levels of
      ADAMTSL4 between patients with IPAH and CTEPH, and to investigate whether serum levels of
      ADAMTSL4 might be used as biomarkers of disease severity in these patient populations.
    

Intervention name(s): drugs or BPA
Intervention type(s): Other
Intervention description(s): PAH target drugs，for example， Tadanafiland, Maxitensin, Prostacyclins, riociguat and etc. CTEPH treat with balloon pulmonary angioplasty or riociguat
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        patients with IPAH and CTEPH compliance with 2015 ESC/ERS Guidelines for the diagnosis and
        treatment of pulmonary hypertension
      
Biospecimen description: 
      blood
Protein Concentrations in Yogurt and Satiety, Food Intake and Glycemia in Healthy Men
Condition: Healthy; Glucose Metabolism
Study type: Interventional

Summary: 
      This study compared the effects of dairy products, including milk and yogurt, with different
      amounts of proteins on responses of appetite, glucose and insulin and on food intake at a
      meal served 120 minutes later in healthy adult male individuals.
    


Intervention name(s): Dietary intervention
Intervention type(s): Other
Intervention description(s): All snacks (arms) were randomly given to subjects to be consumed within 5 minutes, after 4 hours of consuming a standard breakfast.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Yogurt; Milk; Protein; Food intake; Appetite; Glucose; Insulin
Promoting Vegetable Intake in Preschool Aged Children
Condition: Food Habits; Food Preferences; Behavior; Health Behavior
Study type: Interventional

Summary: 
      The aim of this cluster randomised control trial is to test the efficacy of a repeated taste
      exposure intervention, a nutritional educational intervention and combination of both to
      increase intake of an unfamiliar vegetable in preschool aged children (aged 3-5 years).
    

Detailed description: 
      The aim of this study is to test the efficacy of a repeated taste exposure intervention, a
      nutritional educational intervention and combination of both to increase intake of an
      unfamiliar vegetable in preschool aged children (aged 3-5 years). In particular the study
      will assess whether these strategies are effective to encourage intake of an unfamiliar
      vegetable in children who are fussy eaters or going through the food neophobia phase. The
      effectiveness of these interventions will also be observed overtime at 3 and 6 months post
      intervention.

      Nurseries will be randomised into one of four conditions over the 12 week intervention
      period; these include educational intervention only, taste exposures only, taste exposures
      and educational intervention or no intervention (control group). All children will be offered
      an unfamiliar vegetable prior to the intervention and after the intervention to evaluate
      changes in intake of the unfamiliar vegetable. The repeated taste exposure groups will be
      offered the novel vegetable repeatedly (1 exposure per week) over the 12 week period. For the
      educational intervention nursery staff will be advised to deliver two components of an
      existing PhunkyFoods educational programme over the same period.

      Parents will be asked some general demographic questions, child food behaviour questions and
      questions about their feeding practices. Finally nursery staff will be requested to provide
      feedback to evaluate intervention feasibility, barriers and efficacy.

      It is predicted that children's intake of the unfamiliar vegetable will vary by intervention.
      The primary hypothesis to be tested is that children who receive the repeated taste exposures
      are more likely to increase their intake of the unfamiliar vegetable compared to those in
      educational only or control conditions. The second hypothesis is that repeated taste
      exposures will increase intake of an unfamiliar vegetable in fussy eaters more than
      education.
    

Intervention name(s): Taste exposure; Nutritional education
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Exposure to the same vegetable; Eat Well and Strive for Five nutritional education
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Vegetable intake; Taste exposures; Educational intervention; Preschool children; Healthy eating intervention
Effect of Cannabis on Simulated and Actual Driving in Healthy Subjects
Condition: Healthy
MeSH terms: Marijuana Abuse
Study type: Interventional

Summary: 
      Assess the effect of cigarette smoking of tobacco with or without addition of resin cannabis
      on driving performance in healthy volunteers in simulated driving in Marseille and Toulouse,
      and in real world driving to Bordeaux.

      Multicenter Study of phase 1, randomized, double-blind, cross plan, carried out in healthy
      male volunteers.
    

Detailed description: 
      -  To compare performance data driving with the data self-assessed on the ability to drive,
           and the level of sleepiness and fatigue

        -  To measure the effects of distractive task on driving performance, consisting of a
           conversation with co-driver of the real or simulated vehicle (a series of difficult
           questions involving reflection)

        -  To validate the (known) effects of cannabis

        -  To adapt equipment and standardize methods for the pharmacological studies evaluating
           other types of substances having an impact on driving (antihistamines, antidepressants,
           antiparkinsonian ...) and other populations of subjects (men versus women, young versus
           elderly, healthy versus sick ...)

        -  To compare data obtained under conditions of simulated driving and actual driving
           situation, under identical experimental conditions (volunteers, narcotic substance,
           experimental) and measure the degree of ecological validity of the simulation of driving
    

Intervention name(s): Cannabis; tobacco
Intervention type(s): Other; Other
Intervention description(s): a cigarette tobacco trade mark "Drum" with the addition of 250 mg of cannabis resin with 8% of D9THC (20 mg per cigarette)45 minutes before simulating or real driving; a cigarette tobacco trade mark "Drum" 45 minutes before simulating or real driving
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: Social circumstances
A Study of SI-F019 in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the safety, tolerability and pharmacokinetic properties of a single intravenous
      administration of SI-F019 recombinant human bivalent ACE2-Fc fusion protein injection in
      healthy participants, and provide a basis for the design of subsequent clinical trials.
    


Intervention name(s): SI-F019
Intervention type(s): Drug
Intervention description(s): Single dose is administered IV.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Cognitive and Cerebral Blood Flow Effects of 2-week Caffeine Abstinence or Maintenance
Condition: Cognitive Function; Mood; Cerebral Haemodynamics; Caffeine Withdrawal
Study type: Interventional

Summary: 
      The purpose of this study is to determine the effects of 2 weeks caffeine abstinence as
      compared to 2 weeks caffeine maintenance (300mg per day)on cognition and mood. Cerebral blood
      flow effects will also be assessed in a subset of participants. The role of caffeine
      abstinence/maintenance in the acute effects of caffeine will also be explored.
    

Detailed description: 
      The current randomised, placebo-controlled, double-blind, parallel groups study aims to
      explore the behavioural effects of 2-weeks caffeine abstinence as well as establishing the
      role of abstinence in the effects of caffeine administration by administering caffeine or
      placebo to those in a state of chronic and acute abstinence. This research also aims to
      explore, in a subset of participants, the cerebral blood flow effects of caffeine abstinence
      and caffeine administration using Near Infrared Spectroscopy (NIRS). Cerebral blood flow will
      be measured both at rest and during performance of cognitive tasks.
    

Intervention name(s): Placebo; Caffeine and Placebo; Placebo and Caffeine; Caffeine
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Inert placebo containing silica powder CAB-O-SIL-M-5Pharma (Pharmaceutical grade)CABOT GmbH. 1 Size 0 capsule 3 times a day for 14 days and 1 size 0 capsule on day 15.; 100 mg Caffeine capsules 3 times per day for 14 days and 1 size 0 capsule of inert placebo containing silica powder CAB-O-SIL-M-5Pharma (Pharmaceutical grade)CABOT GmbH on day 15.; Inert placebo capsules containing silica powder CAB-O-SIL-M-5Pharma (Pharmaceutical grade)CABOT GmbH, 1 Size 0 capsule 3 times a day for 14 days and a 100mg caffeine capsule on day 15.; Capsule containing 100 mg caffeine, one 3 times a day for 14 days and then one capsule on day 15.
Intervention MeSH terms: Caffeine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Caffeine; Withdrawal; Cognitive function; Mood; Cerebral haemodynamics
A Trial Investigating the Pharmacokinetic and Pharmacodynamic Properties of Faster-acting Insulin Aspart in Subjects With Type 2 Diabetes Mellitus
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      A Trial Investigating the Pharmacokinetic and Pharmacodynamic Properties of Faster-acting
      Insulin Aspart in Subjects with Type 2 Diabetes Mellitus
    


Intervention name(s): Faster-acting insulin aspart; Insulin Aspart
Intervention type(s): Drug; Drug
Intervention description(s): A single dose administered subcutaneously (s.c., under the skin). The dose level will be 0.3 U/kg body weight.; A single dose administered subcutaneously (s.c., under the skin). The dose level will be 0.3 U/kg body weight.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin, Long-Acting; Insulin degludec, insulin aspart drug combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Study to Evaluate the Immune Responses of Trivalent Cold-Adapted Influenza Vaccine (CAIV-T) Compared With (TIV)
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to describe the level of serum antibody conferred by CAIV-T and
      TIV against homotypic and heterotypic influenza virus strains.
    


Intervention name(s): CAIV-T; TIV
Intervention type(s): Biological; Other
Intervention description(s): A total vol. of 0.2 mL will be administered intranasally (approx. 0.1 mL into each nostril)for ea. of two doses.; A total vol. of 0.25 will be administered intramuscularly for each of two doeses.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Risedronate in Postmenopausal Women With Low Bone Density
Condition: OSTEOPOROSIS, POSTMENOPAUSAL
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal; Bone Diseases, Metabolic
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this pilot study is to estimate the percent change from baseline at
      Week 4, Month 6 in NTX bone turnover marker for a monthly 150mg dose of risedronate
      administered for 6 months and a loading dose regimen of risedronate over a 6 month treatment
      period both compared to a 5 mg daily dose of risedronate for 6 months

      The secondary objectives are :

        -  To estimate the percent change from baseline at specified visits other than Week 4,
           Month 6 in NTX for the monthly 150 mg dose of risedronate administered for 6 months and
           the loading dose regimen of risedronate over a 6 month treatment period both compared to
           the 5 mg daily dose of risedronate.

        -  To estimate the percent change from baseline at all specified visits in serum CTX and
           bone specific alkaline phosphatase for the monthly 150 mg dose of risedronate
           administered for 6 months and the loading dose regimen of risedronate over a 6 month
           treatment period both compared to the 5 mg daily of risedronate.

        -  To estimate the percent change from baseline at Month 6 in lumbar spine BMD for the
           monthly 150 mg dose of risedronate administered for 6 months and the loading dose
           regimen of risedronate over a 6 month treatment period both compared to the 5 mg daily
           dose of risedronate.

        -  To evaluate the safety of the risedronate 150 mg monthly and the loading dose regimen.
    


Intervention name(s): RISEDRONATE
Intervention type(s): Drug
Intervention MeSH terms: Risedronic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
MRI in Clinical Staging and Estimation of Treatment Response in Bladder Cancer
Condition: Bladder Cancer
MeSH terms: Urinary Bladder Neoplasms
Study type: Interventional

Summary: 
      Bladder cancer (BC) as the most common malignancy arising from the urinary tract continues to
      be a major health problem. This prospective non-randomized study will enroll 150 patients
      undergoing magnetic resonance imaging (MRI) at different stages of their diagnostic and
      therapeutical process. The enrolled patients with suspected BC (BC) based on cystoscopy will
      have their initial MRI examination before transurethral resection of bladder tumor (TUR-BT)
      and biomarker collection. After pathology review of the histological specimens, patients will
      be treated according to standard clinical practice. The second MRI examination will be
      performed before therapeutic intervention, if TUR-BT alone is not sufficient enough.
      Neoadjuvant chemotherapy will be applied in high risk patients having muscle invasison, while
      intermediate risk patient - T1 high grade or carcinoma in situ patients - will be treated
      using Bacillus Calmette-Guerin (BCG) instilliations. After the completion of the neoadjuvant
      chemotherapy or BCG treatment, the patients will undergo the third MRI examination. Low risk
      patients will be followed by annual with MRI examination.
    


Intervention name(s): MR imaging
Intervention type(s): Device
Intervention description(s): 3 T MRI of the urinary bladder
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: bladder cancer; MRI; TUR-BT; cystectomy; chemotherapy
Drug-drug Interaction Study Between EDP-305, Intraconazole and Rifampin in Healthy Volunteers
Condition: NASH - Nonalcoholic Steatohepatitis
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a non-randomized, 2-part, open-label, drug-drug interaction (DDI) study to evaluate
      the effect of concomitant administration of itraconazole or rifampin on the pharmacokinetics
      and safety of EDP-305 in healthy human volunteers.
    


Intervention name(s): intraconazole; Rifampin; EDP 305
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Subjects will receive itraconazole once daily from Day 5 through Day18; Subjects will receive rifampin once daily from Day 5 through Day 16; Subjects will receive EDP 305 once daily on Day 1 and Day 14
Intervention MeSH terms: Rifampin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: 2-Part Single Group study.
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: drug-drug interaction