bioihbjkbjnl/mcl2 huggingface dataset:
Low-dose Maximal-intent Versus Controlled-tempo Resistance Training on Quality-of-life in Adults
Condition: Quality of Life
Study type: Interventional

Summary: 
      The aims of this study were to:

        1. Compare the effects of low-dose Maximal Intent and Controlled Tempo Resistance Training
           on untrained healthy adults' quality-of-life, functional capacity, and strength.

        2. Qualitatively explore perceptions of Maximal Intent and Controlled Tempo Resistance
           Training.
    


Intervention name(s): Leg Press Resistance Training Machine
Intervention type(s): Other
Intervention description(s): Participants used said unilateral leg press at 60% one-repetition max for either 3 sets x 5 reps, or 5 sets x 5 reps, at either maximal- or controlled-tempo-intent.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Activities of Daily Living; Balance; Independence; Mobility; Untrained
Evaluation of the QuantiFERON-TB Test.
Condition: Tuberculosis
MeSH terms: Tuberculosis
Study type: Observational

Summary: 
      To compare the results of the investigational test to the currently approved QuantiFERON-TB
      Gold In-Tube test.
    

Detailed description: 
      To compare the specificity of the CST001 assay to the QFT Gold Test in low TB exposure risk
      subjects and non-tuberculosis mycobacterial infections.
    

Intervention name(s): CST_001
Intervention type(s): Device
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who have either low-exposure rist to tuberculosis or have non-tuberculous
        mycobacterial infections
      
Keywords: Tuberculosis; TB
An Extension Study Designed to Assess Effects of Losartan on Proteinuria in Pediatric Populations (MK-0954-326 AM1,EXT1(AM2))
Condition: Proteinuria
MeSH terms: Proteinuria
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the effects of losartan on proteinuria in pediatric
      patients.
    

Detailed description: 
      The study included a 12-week double-blind treatment phase and a 36-month open-label extension
      phase. Participants who completed or discontinued the initial 12-week phase of the study and
      who opted to participate in the open label extension phase were randomized to either losartan
      or enalapril at a dose of the investigator's choosing for the duration of the extension. The
      open label extension was designed to continue until the 100th participant completed 3 years
      of follow-up.
    

Intervention name(s): Losartan Potassium; Comparator: Placebo (Losartan); Comparator: amlodipine besylate; Comparator: Placebo (amlodipine besylate); Placebo (Losartan); Enalapril Maleate
Intervention type(s): Drug; Other; Drug; Other; Other; Drug
Intervention description(s): Losartan Use During the Double-Blind Treatment Phase:
Losartan potassium was administered orally as tablets; 25 or 50 milligrams (mg); or as a liquid suspension 2.5 mg/mL prepared for participants who weighed less than 25 kilograms (kg) or for those participants unable to swallow tablets. During the double-blind period, participants were initially randomized to either a once-daily weight-dependent dose of approximately 0.7 mg/kg (25 mg tablet; up to 50 mg per day) and at 2-weeks the dose was increased to a once-daily maximum weight-dependent dose of 1.4 mg/kg. The maximum dose of losartan, as specified in the protocol, was 50 mg/day (if the patient weighed <50 kg)
or 100 mg/day (if the patient weighed ≥50 kg).
Losartan Use During the Treatment Extension Phase:
Dose modifications of the drug were left up to the discretion of the Investigators based on each participant's level of tolerance.; Placebo (losartan suspension), administered orally, once daily for 12 weeks; Amlodipine besylate (1 mg/mL) liquid suspension, oral administration, titrated to 0.2 mg/kg/day (5 mg maximum dose) per day for 12 Weeks; Liquid suspension, 1mg/mL, titrated to 0.2 mg/kg/day (5 mg maximum dose) once daily, for 12 weeks; Normotensive patients randomized to losartan placebo for 12 weeks.; Enalapril 2.5-, 5-, 10-, and 20-mg tablets or enalapril suspension (1 mg/mL), oral administration, once daily for 36 months.
Other intervention name(s): Cozaar®; NORVASC®; NORVASC®; Vasotec®; Renitec®
Intervention MeSH terms: Losartan; Amlodipine; Enalapril; Enalaprilat
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Development, Feasibility Testing and Validation of a Survey Set to Measure Patient-Reported Outcomes Among Hemodialysis Patients in Turkey
Condition: Renal Failure; End Stage Renal Disease
MeSH terms: Kidney Failure, Chronic
Study type: Observational

Summary: 
      Development, feasibility testing and validation of a Survey Set to Measure Patient-Reported
      Outcomes among Hemodialysis Patients in Turkey: Creating and testing an electronic patient
      questionnaire that is suitable to measure health-related quality of life in Turkish dialysis
      patients in clinical as well as in home care settings.
    

Detailed description: 
      Individuals with chronic kidney disease represent a growing population in adult and pediatric
      practices. This has resulted in a drive to optimize patient care and outcomes. Historically,
      healthcare outcomes focused on morbidity, mortality or complication rates, but failed to
      provide meaningful data on the value of medicine to patients and the quality of life gained
      or lost. Several studies have revealed that treatments aimed at minimizing morbidity and
      mortality in end-stage renal disease (ESRD) have very often been ineffective. Therefore,
      attention to HRQOL among ESRD patients is crucial.

      The aim of this pilot study is creating and testing an electronic patient questionnaire that
      is suitable to measure health-related quality of life in Turkish dialysis patients. This
      questionnaire consists of the PROMIS Cognitive Function and Abilities Subset, the PROMIS-29,
      a new post-dialysis recovery time module, the MOS-Social Support Scale (MOS-SSS), Subscales
      of the KDQOL SF 1.3 (sexual function & cognitive function), the General Self-Efficacy Scale
      and the Health Services Utilization And Productivity Loss Survey which are to be delivered
      together on a tablet computer.
    

Intervention name(s): Administration of patient questionnaire
Intervention type(s): Other
Intervention description(s): Patients undergoing maintenance hemodialysis complete electronic questionnaires on a tablet computer during this study to assess patient reported outcomes.
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Turkish dialysis patients (in center or home dialysis)
      
Keywords: Hemodialysis; Psychometric tests; Patient questionnaire
Clinical Studies of Gemcitabine-Oxaliplatin
Condition: Medulloblastoma; Central Nervous System Tumors; Neuroblastoma; Osteosarcoma
MeSH terms: Neuroblastoma; Osteosarcoma; Nervous System Neoplasms; Central Nervous System Neoplasms; Medulloblastoma
Study type: Interventional
Phase: Phase 2

Summary: 
      These are Phase 2 single-arm studies of gemcitabine in combination with oxaliplatin in
      refractory or relapsing pediatric solid tumors.
    


Intervention name(s): Gemcitabine (Gemzar®), Oxaliplatin (Eloxatin®)
Intervention type(s): Drug
Intervention MeSH terms: Gemcitabine; Oxaliplatin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Gemcitabine; Oxaliplatine; Paediatric solid tumors; Other CNS tumors; Other miscellaneous solid non-CNS tumours
Study on the Effect of Electroacupuncture at Both Zusanli and at Both Yanglingquan Acupoints on Cardiovascular Activity
Condition: Reaction of Autonomic Nervous System; Reaction of Acupuncture; Reaction of Blood Circulation
Study type: Interventional

Summary: 
      The purpose of this present study was to investigate the effect of electroacupuncture at both
      Zusanli and at both Yanglingquan acupoints on autonomic nerve modulating cardiovascular
      activity, and skin blood flow and skin temperature. The investigators use pulse rate
      variability to investigate autonomic nerve modulates cardiovascular function, and using
      distant skin blood flow and skin temperature recordings to investigate the relationship
      between the same names meridian of hand and foot.
    

Detailed description: 
      A total of 24 adult healthy volunteer were studied, they received the three sessions of sham
      electroacupuncture, electroacupuncture at Zusanli and electroacupuncture at Yanglingquan,
      respectively. Each session was divided into three periods of before electroacupuncture,
      electroacupuncture, and post electroacupuncture. Each period was 20 min in duration. The
      ahead 15 min of the period was the skin blood flow and skin temperature recordings at Hoku's
      and Zhongzhu's region of right hand; the final 5 min of the period was pulse rate variability
      recordings of left hand. The data was storage and analysis in a personal computer.
    

Intervention name(s): acupuncture
Intervention type(s): Device
Intervention description(s): electroacupuncture at at Zusanli, electroacupuncture at Yanglingquan, and acupuncture at non-acupoint.
Allocation: Non-Randomized
Intervention model: Factorial Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Pulse Rate Variability; Skin Blood Flow; Skin Temperature; Electroacupuncture; Zusanli; Yanglingquan
A Study to Investigate the Safety, Tolerability and Pharmacokinetics of RD01 (Pegerythropoietin) in Healthy Chinese Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      A first-time in human study to investigate the safety, tolerability and pharmacokinetics of
      RD01 in healthy Chinese subjects
    

Detailed description: 
      A Phase 1, Randomised, Double-blind, Single-centre, Placebo-controlled, Dose-Escalation study
      to evaluate the Safety, Tolerability and Pharmacokinetics of single S.C. doses of RD01
      (Pegerythropoietin) in Healthy Chinese Subjects. Doses were escalated from 0.2μg/kg up to
      4.8μg/kg with 12 subjects (randomized to 5:1 for test or placebo) in every cohort.
    

Intervention name(s): RD01; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): single S.C. dose of RD01 for subjects in test group; single S.C. dose of placebo for subjects in placebo group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
First in Human Study of ChAdOx1-HBV
Condition: Hepatitis B; Healthy
MeSH terms: Hepatitis B
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, first in human study of ChAdOx1-HBV. The study will be conducted in 40
      healthy participants and 12 participants with CHB and virally suppressed with oral antiviral
      medication. This will be an open-label, non randomised dose escalation study comparing the
      safety, tolerability and immunogenicity of 2 different doses of ChAdOx1 HBV vaccine. T cell
      responses in healthy participants who have received a prior two-dose series of AZD1222 will
      be compared with those who have received either the Pfizer COVID 19 vaccine or the Moderna
      mRNA COVID 19 vaccine.
    

Detailed description: 
      This is a first in man human study of a therapeutic vaccine for chronic hepatitis B
      infection(ChAdOx1-1HBV). The vaccine will be given to participants in a dose escalation
      strategy (two doses). Five healthy participants will be administered the low dose first
      (cohort 1). Dose escalation will only be initiated in the next 5 healthy participants (cohort
      2) following Safety Monitoring Committee (SMC) review.

      Six CHB participants will be administered the low dose (cohort 3) before the dose escalation
      is initiated in the remaining 6 CHB participants (cohort 4).

      Thirty healthy participants (15 who have received two doses of AZD1222 [cohort 5] and 15 who
      have received at least two prior doses of Pfizer/Moderna mRNA COVID 19 vaccine [cohort 6])
      will be dosed in parallel with the high dose used in cohorts 2 and 4.

      Each participant will receive 1 dose of the vaccine (intramuscular injection). Participants
      (Volunteers & patients) in cohorts 1 to 4 will attend up to 9 study visits and cohorts 5 & 6
      will attend up to 4 visits in total. The last visit will be 24 weeks after vaccination for
      cohorts 1 to 4 and 12 weeks for cohorts 5 & 6.
    

Intervention name(s): ChAdOx1-HBV
Intervention type(s): Biological
Intervention description(s): chimpanzee adenovirus-vectored hepatitis B virus vaccine
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: The participants will be recruited in 6 cohorts as follows - Cohort 1 - Healthy Volunteers - Low dose Vaccine - 5 participants Cohort 2 - Healthy Volunteers - High dose Vaccine - 5 participants Cohort 3 - Participants with Chronic Hepatitis B infection - Low dose - 6 participants Cohort 4 - Participants with Chronic Hepatitis B infection - High dose - 6 participants Cohort 5 - Healthy Volunteers who have completed 2 doses of COVID-19 AZD1222 vaccine Cohort 6 - Healthy Volunteers who have completed 2 doses of either Pfizer or Moderna mRNA COVID 19 vaccine
Masking: None (Open Label)
Primary purpose: Treatment
Effects of a Limited Almond Consumption After a Weight Loss Plan on Weight Maintenance
Condition: Obesity; Overweight
MeSH terms: Overweight; Weight Loss
Study type: Interventional

Summary: 
      The purpose of this study is to assess the effects of limited portion of almond consumption
      after a successful weight loss by a comprehensive weight loss plan (NovinDiet Plan) on weight
      maintenance in obese female adults.
    


Intervention name(s): Almond Group; Nut Free group
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Almond Group (AG) are asked to have a 30 gr. almond every day in their afternoon snack plus following the hypoenergetic diet; continue their diet without any nut consumption.
Other intervention name(s): AG group; NFG
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Almond Group (AG) are asked to have a 30 gr. almond every day in their afternoon snack plus following the hypoenergetic diet Nut Free group (NFG), as control group, who continue their diet without any nut consumption.
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: almond; weight loss; Weight maintenance; hypoenergetic diet
Activity and Participation in Ambulatory Cerebral Palsy
Condition: Cerebral Palsy
MeSH terms: Cerebral Palsy
Study type: Observational

Summary: 
      The investigators would like to understand how the physical activity levels and body size of
      a child with cerebral palsy (CP) in a clinical situations versus out in the community relates
      to what they want to do in day to day life (participation in life). The investigators believe
      that what a child really does out in day to day life will predict life participation to a
      greater degree than what they do in a structured clinical situation (i.e. therapy session
      with therapist). The investigators think that increased body size with normal growth is
      related to less physical activity and participation in day to day life for children with
      cerebral palsy (CP) who can walk. This project will use a novel accelerometer to measure
      walking activity during day to day life.
    

Detailed description: 
      We want to know how the physical activity of children with walking problems or cerebral palsy
      (CP) relates to what they do in their day to day lives.

      We are looking for children who:

        -  Have walking problems that started before age 2

        -  Have any type of cerebral palsy (CP) or primary problem that is a developmental movement
           disorder

        -  May have hemiplegia, diplegia, walking quadriplegia, May have ataxia, spastic, mixed
           tone, athetoid, or dyskinetic

        -  Ages 2 years to less than 10 years

        -  Able to do some functional walking with or without help(walkers, gait trainers)

        -  Project requires a one time visit to Seattle Children's Hospital of about 2 hours.

        -  Children and/or parents will complete surveys.

        -  The child will be tested for their gross motor and walking skills like at a physical
           therapy session.

        -  The child will be given an ankle monitor to wear for 7-10 days.

        -  They will return the monitor by mail with a questionnaire about what they did the last
           week.

        -  Families will receive a print out of their child's walking activity
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Children with cerebral palsy (CP) or developmental movement disorder before age two who are
        able to walk
      
Keywords: cerebral palsy; walking activity; physical activity; participation; activity performance; activity capacity
Medical Treatment of Early-Enamel Carious Lesion Using Different Remeneralizing Agents
Condition: Enamel Caries
MeSH terms: Dental Caries
Study type: Interventional

Summary: 
      Medical Treatment of Early-Enamel Carious Lesion using Different Remeneralizing agents
    

Detailed description: 
      Medical management of incipient lesions by application of remineralizing agents like fluoride
      therapy, amorphous calcium phosphate (ACP), and Casin phosphopeptide amorphous calcium
      phosphate (CPP-ACP) has proved to be effective in reversing such lesions.

      Fluoride was considered the "gold standard" remineralizing agent , However several recent
      researchers found that; the ideal remineralizing agents should diffuse or deliver calcium and
      phosphate ions into early enamel lesion.

      Calcium-silicate based material such as β-CaSiO3 and β-Ca2SiO4 play an important role in hard
      tissue regeneration, showing good bioactivity and biocompatibility and can induce bone like
      apetite formation in stimulated body fluids. when β-CaSiO3 and β-Ca2SiO4 come in contact with
      saliva it will be dissolve forming silanol group (Si-O ) on the enamel surface which can bind
      to Ca ions and inducing the precipitation of hydroxyapatite.

      In the light of this, this study was designed to compare the remineralization potential of
      silver diamine flouride/ potassium iodide, casin phosphopeptide amorphous calcium phosphate
      and experimental tricalcium silicate on early enamel lesions.
    

Intervention name(s): Silver diamine fluoride- potassium iodide; Casein phosphopeptide amorphous calcium phosphate; experimental tricalcium silicate
Intervention type(s): Drug; Drug; Drug
Intervention description(s): SDF-KI (riva star, SDI.Ltd )was applied ( as a professional application) by micro brush over the early enamel lesions on the buccal surface of molar teeth; CPP-ACP (tooth mousse, GC, Matraville Sydney, Australia) was applied by using micro brush over the early enamel lesions on the buccal surface of the molar teeth twice daily. the patients were instructed to leave it for about 3minutes before rinsing; prepared tricalcium silicate paste was applied by using micro brush over the early enamel lesions on the buccal surface of the molar teeth twice daily. the patients were instructed to leave it for about 3minutes before rinsing
Intervention MeSH terms: Calcium; Fluorides; Caseins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Enamel remineralization; Randomized Clinical Trial; Experimental Tricalcium silicate; Sillver diamine flouride-potassium iodide
Neointimal Coverage After Implantation of Biolimus Eluting Stent With Biodegradable Polymer: Optical Coherence Tomographic Assessment According to the Treatment of Dyslipidemia and Hypertension and the Types of Implanted Drug-eluting Stents
Condition: Stable Angina or Acute Coronary Syndrome Considered for Percutaneous Coronary Intervention With Dyslipidemia or Hypertension
MeSH terms: Hypertension; Acute Coronary Syndrome; Angina, Stable; Dyslipidemias
Study type: Interventional
Phase: Phase 4

Summary: 
      There has been little research on neointimal coverage and malapposition after BES
      implantation using OCT in human coronary artery. Furthermore, specific drug may possibly
      influence the vascular healing after stent implantation. Therefore, this study will
      investigate 1) neointimal coverage and malapposition on OCT after BES versus SES implantation
      and 2) relationship of specific drug treatment and neointimal coverage or late malapposition
      by the prospective, randomized study.
    


Intervention name(s): Sirolimus-eluting stent; Biolimus-eluting stents; pravastatin 20mg/day after DES implantation; pitavastatin 2mg/day after DES implantation; Non-ARB /day after DES implantation; Eposartan 600mg/day after DES implantation
Intervention type(s): Device; Device; Drug; Drug; Drug; Drug
Intervention description(s): 2x2 randomization by the treatment of dyslipidemia and hypertension(In patients of dyslipidemia: pitavastatin 2mg/day vs. pravastatin 20mg/day, in patients of hypertension: eporsartan 600mg/day vs. Non-ARB) and the types of the implanted DES, SES vs BES.; 2x2 randomization by the treatment of dyslipidemia and hypertension(In patients of dyslipidemia: pitavastatin 2mg/day vs. pravastatin 20mg/day, in patients of hypertension: eporsartan 600mg/day vs. Non-ARB) and the types of the implanted DES, SES vs BES.; 2x2 randomization by the treatment of dyslipidemia and hypertension(In patients of dyslipidemia: pitavastatin 2mg/day vs. pravastatin 20mg/day, in patients of hypertension: eporsartan 600mg/day vs. Non-ARB) and the types of the implanted DES, SES vs BES.; 2x2 randomization by the treatment of dyslipidemia and hypertension(In patients of dyslipidemia: pitavastatin 2mg/day vs. pravastatin 20mg/day, in patients of hypertension: eporsartan 600mg/day vs. Non-ARB) and the types of the implanted DES, SES vs BES.; 2x2 randomization by the treatment of dyslipidemia and hypertension(In patients of dyslipidemia: pitavastatin 2mg/day vs. pravastatin 20mg/day, in patients of hypertension: eporsartan 600mg/day vs. Non-ARB) and the types of the implanted DES, SES vs BES.; 2x2 randomization by the treatment of dyslipidemia and hypertension(In patients of dyslipidemia: pitavastatin 2mg/day vs. pravastatin 20mg/day, in patients of hypertension: eporsartan 600mg/day vs. Non-ARB) and the types of the implanted DES, SES vs BES.
Intervention MeSH terms: Sirolimus; Pravastatin; Pitavastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: SES vs BES