bioihbjkbjnl/mcl2 huggingface dataset:
Bikes For Life: Measuring the Effects of a Bicycle Distribution Program on Pediatric Obesity
Condition: Obesity, Childhood
MeSH terms: Obesity; Pediatric Obesity
Study type: Interventional

Summary: 
      The investigators propose a study to evaluate the success of a bicycle distribution program
      in increasing physical activity level, decreasing sedentary activity levels and positively
      affecting body-mass index (BMI) in participants aged 6 to 12 years old with overweight or
      obesity, who do not already own a bicycle, and are patients at the Children's Hospital
      Colorado Child Health Clinic (CHC), Lifestyle Medicine Clinic, or Rocky Mountain Youth
      Clinics. The investigators anticipate that the receipt of a bicycle will increase physical
      activity level, decrease sedentary activity time and decrease or stabilize patients' BMI. The
      investigators will answer this research question by distributing bicycles to 525 children and
      conducting follow up visits over the course of a year to measure the outcomes of interest.
    


Intervention name(s): Bicycle intervention
Intervention type(s): Other
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a stepped-wedge, randomized controlled trial. Possible subjects will be randomized to 1 of 4 groups. Each patient will serve as his or her own control. Within each stratum of four, patients will be randomly assigned to intervention initiation times (~130 per initiation time). Intervention initiation times will occur every other month up to a maximum of six months.
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of White Sweet Potato Tube Feeding Formula on Type 2 Diabetic Residents in Long-term Care Institutions
Condition: Type 2 Diabetes
Study type: Interventional

Summary: 
      In order to response the increasing of aging population cause losing ability that need
      long-care needs, the project entitled "10-year long-term care program" from Executive Yuan in
      2007 is carried out to assist economically disadvantaged and disabled elderly to acquire
      daily nutrition. Therefore, the long-term care resident's nutritional status got more
      attention than before. Out of control in blood glucose will not only increase bed sores and
      urinary tract infection in tube feeding residents but also rise medical expenditures. The
      nutritional status of long-term care institutions, anyang homes and nursing home are
      generally bad in nutrition management due to high cost of nutritional supplements from
      foreign imports that cause the burden of families. In this study, we will recruit diabetic
      subjects that divide into white sweet potato group (experimental group) and commercial
      formula group (control group) by using randomized, parallel and open clinical study through
      tube feeding in sixty days.
    

Detailed description: 
      All subjects will be evaluated the blood sugar and clinical nutrition assessment such as
      postural measurement, urine test and blood biomarker examination.
    

Intervention name(s): Commercial diabetic formula; White sweet potato formula
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): The formula were supplied 1500~1800 kcal daily depend on the patient's individual situation; The formula were supplied 1500~1800 kcal daily depend on the patient's individual situation
Other intervention name(s): diabetic formula; White sweet potato
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Efficacy and Safety of Alogliptin in Participants With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to determine the efficacy of alogliptin compared to placebo when
      given alone or as add-on therapy to metformin or add-on to pioglitazone (with or without
      metformin).
    

Detailed description: 
      Diabetes is a chronic illness associated with microvascular complications such as nephropathy
      (kidney disease), retinopathy (eye damage) and neuropathy (nervous system damage). Diabetes
      is also associated with macrovascular complications including cardiovascular disease (heart
      disease), stroke and peripheral vascular disease (narrowing or blockage of blood vessels).
      These complications are associated with reduced quality of life and increased morbidity and
      mortality.

      Takeda is developing SYR-322 (alogliptin) for improvement of glycemic control in patients
      with Type 2 diabetes mellitus.

      Evaluations of alogliptin and its clinical efficacy have been conducted in multiple countries
      including the United States and Japan. This study will be conducted as a multi-center
      clinical trial in order to validate the efficacy and safety of alogliptin on type 2 diabetes
      population within Asia.

      Participants who qualified for the study were stratified into 1 of the 3 therapy groups based
      upon their background antidiabetic therapy before being randomized 1:1 to receive either
      alogliptin 25 mg once daily or matching placebo once daily.

        -  Monotherapy group - patients who had been treated with diet and exercise for at least 2
           months prior to screening.

        -  Add-on to metformin therapy group - patients who had been treated with metformin for at
           least 3 months and at a stable dose (≥1000 mg/day) for at least 8 weeks prior to
           screening.

        -  Add-on to pioglitazone therapy group - patients who had been treated with a stable dose
           of pioglitazone alone or in combination with metformin at a stable dose for at least 8
           weeks prior to screening.
    

Intervention name(s): Alogliptin; Placebo to alogliptin; Metformin; Pioglitazone
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Alogliptin tablets; Alogliptin placebo-matching tablets.; Stable metformin dose; Stable pioglitazone dose
Other intervention name(s): SYR-322; Fortamet; Glucophage; Glumetza; Actos
Intervention MeSH terms: Metformin; Pioglitazone; Alogliptin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Type 2 Diabetes Mellitus; Drug Therapy
Does Minimally Invasive Surgery Reduce Anxiety?
Condition: Anxiety
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      The purpose of this study was to identify factors that may contribute to anxiety of patients
      undergoing total abdominal hysterectomy(TAH) or total laparoscopic hysterectomy(TLH) before
      and after the operation. Thus, we aimed to learn whether anxiety levels change according to
      the type of hysterectomy.
    

Detailed description: 
      Hysterectomy is the most common gynecological procedure worldwide. . There has been a
      increasing interest towards to more minimally invasive procedures in the past decade.
      Hysterectomy operation anxiety is a complex phenomenon affected by various parameters.
      Patients' anxiety may be affected by their age, gender, educational status,type of operation
      and personality. Each patient's anxiety was measured using Spielberger's State-Trait Anxiety
      Inventory immediately before, immediately after the operation.
    

Intervention name(s): Spielberger's State-Trait Anxiety Inventory(STAI ); total laparoscopic hysterectomy(TLH); total abdominal hysterectomy(TAH)
Intervention type(s): Behavioral; Procedure; Procedure
Intervention description(s): State anxiety (STAI-S) refers to a temporary emotional state related to a specific situation, whereas trait anxiety (STAI-T) represents anxiety as a relatively stable personality character. Each scale has values ranging from 20 to 80, with higher scores representing more severe anxiety. The STAI has no established categories, but a cutoff score of 40 has been used to identify patients with high/very high anxiety. The validity and reliability of the Turkish versions of these instruments have been validated.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
rhGH Therapy on Hepatic Drug Metabolism
Condition: Growth Hormone Deficiency, Dwarfism
MeSH terms: Dwarfism
Study type: Observational

Summary: 
      The purpose of the study is to understand the effect of rhGH therapy on hepatic drug
      metabolism in children with idiopathic growth hormone deficiency.
    

Detailed description: 
      Growth Hormone (GH) deficiency is a prominent cause of short stature, affecting approximately
      14,000 children in the US. Although a single study has demonstrated reduces CYP1A2 activity
      following Gh replacement therapy, the effect of GH on the most abundant phase 1
      biotransformation pathways (e.g. CYP2D6 and CYP3A4) remain largely uncharacterized. This
      information gap exists largely due to the lack of sufficiently safe, specific and
      non-invasive methods appropriate for the longitudinal evaluation of enzyme activity in young
      children. We can overcome these problems by employing validated phenotyping methods using
      caffeine, a commonly ingested dietary substance and dextromethorphan, a safe, non-sedating
      over the counter anti-tussive agent. Application of these methods will permit us to identify,
      characterize and describe the isoform-specific effects of rhGH on major phase 1 hepatic drug
      biotransformation pathways, thereby addressing this information gap with minimal risk to
      children.
    

Intervention name(s): Dextromethorphan and Caffeine
Intervention type(s): Drug
Intervention description(s): All subjects received standard medical therapy with rhGH and at specified times low doses of the pharmacologic "probes" (e.g., caffeine and dextromethorphan) as surrogate markers to determine CYP450 activity. The only direct treatment effect measured was the biological response to rhGH.
Intervention MeSH terms: Dextromethorphan; Caffeine
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children recently diagnosed with idiopathic GH deficiency who were candidates for rhGH
        therapy were eligible for enrollment. All subjects were recruited via informed parental
        consent and patient assent (for children > 7 years). The anticipated sample size was 12
        children.
      
Keywords: Recombinant Human Growth Hormone; growth hormone deficiency; short stature; phenotyping
High Dose of Dual Therapy Plus Metronidazole for Helicobacter Pylori RescueTreatment
Condition: Helicobacter Pylori Infection
Study type: Interventional
Phase: Phase 4

Summary: 
      Dual therapy containing high dose of proton pump inhibitor (PPI) and amoxicillin had showed
      excellent eradication results with Helicobacter pylori first-line treatment. However, no
      study has examined the the efficacy of high dose of dual therapy or dual therapy plus
      metronidazole for H. pylori rescue treatment.This study is designed to evaluate the efficacy
      and safety of the addition of metronidazole to high dose of dual therapy for H. pylori rescue
      treatment.
    


Intervention name(s): Esomeprazole; Amoxicillin; Metronidazole
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Proton pump inhibitor; Antibiotic for H. pylori eradication; Antibiotic for H. pylori eradication
Intervention MeSH terms: Amoxicillin; Metronidazole; Esomeprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Bioequivalence Study of Amlodipine Tablets Under Fasting Conditions
Condition: Healthy
Study type: Interventional

Summary: 
      The objective of this study was to compare the rate and extent of absorption of Ranbaxy
      amlodipine 10 mg tablet to that of Norvasc® 10 mg tablet after a single, one4ablet dose in
      fasted subjects.
    

Detailed description: 
      The study was conducted as an open label, balanced, randomised, two-treatment, two-period,
      two-sequence, single-dose, crossover , bioequivalence study on Amlodipine besylate
      formulations comparing Amlodipine 10mg tablets of Ranbaxy Laboratories with (Norvasc®, Pfizer
      Inc USA, in healthy, adult, human, subjects under fasting conditions
    

Intervention name(s): amlodipine 10 mg tablet
Intervention type(s): Drug
Intervention MeSH terms: Amlodipine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Bioequivalence amlodipine tablets fasting
Rapid Detection of Staphylococcus Aureus in Burn Patients
Condition: Burns; Sepsis
MeSH terms: Sepsis; Burns
Study type: Interventional

Summary: 
      The purpose of this study is to determine if rapid early detection of the bacteria causing
      sepsis in burn patients improves patient outcomes.
    

Detailed description: 
      Burn patients have lost their primary barrier to microorganism invasion and therefore are
      continually and chronically exposed to pathogens. Ninety-seven percent of patients with >20%
      total body surface area (TBSA) burns develop septicemia; predominantly involving gram
      positive cocci including MRSA and methicillin sensitive Staphylococcus aureus. Blood culture
      (BC) is the traditional detection method for septicemia. However, antibiotics and inadequate
      sample volumes can impair detection by BC and results can take 3-4 days.

      Polymerase chain reaction (PCR) represents a potential adjunct to BC. Pathogens are detected
      in a growth-independent manner by targeting their genetic make-up. Quantitative determining
      of pathogen DNA using PCR could aid in determining antimicrobial drug therapy efficacy by
      providing results on the same testing day as opposed to 3-4 days with BC. PCR may also detect
      persistent infections during antimicrobial therapy when culture samples are inhibited.

      The aims of this study are:(1)to correlate quantitative PCR results with that of the BC; (2)
      to test the clinical application of PCR results with clinical outcomes of treatment of
      presumptive diagnosis of staphylococcal sepsis.
    

Intervention name(s): PCR test
Intervention type(s): Other
Intervention description(s): PCR samples will test for Staphylococcus aureus (including MRSA) from wound swab and positive blood culture samples to augment treatment decisions. Serial PCR testing will follow after positive results to catalog pathogen loads over the course of treatment in a blinded fashion.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Burn; Sepsis; Infection
Association of Genetic Polymorphism and Acute Kidney Injury After Liver Transplantation
Condition: Liver Transplantation
Study type: Observational

Summary: 
      Some of the liver transplantation recipients experience postoperative acute kidney injury due
      to various causes including genetic factors. Prevention of postoperative acute kidney injury
      is essential for postoperative care in liver transplantation recipients. The aim of this
      study is to investigate the relationship between gene polymorphisms which have been known to
      be associated with postoperative acute kidney injury, and the occurrence of acute kidney
      injury after liver transplantation.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adult patients scheduled for liver transplantation
      
Biospecimen description: 
      blood obtained from enrolled patients before surgery
A Study to Evaluate Pegylated Interferon Lambda Monotherapy in Patients With Chronic Hepatitis Delta Virus Infection
Condition: Hepatitis D, Chronic
MeSH terms: Hepatitis A; Virus Diseases; Hepatitis D; Hepatitis D, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate safety and tolerability of lambda over a 48-week treatment period in HDV
      patients.
    

Detailed description: 
      Lambda is the pegylated form of interferon lambda-1a (IFN-λ), a conjugate of recombinant
      human interleukin 29 (rIL-29) and a linear polyethylene glycol (PEG) chain. IFN-λ and
      interferon alpha (IFN-α) share the common interferon (IFN)-stimulated gene induction pathway
      that leads to broad-spectrum antiviral activities. Since IFN-α has demonstrated
      anti-hepatitis delta virus (HDV) activity in patients with chronic hepatitis delta (CHD), it
      is postulated that pegylated IFN-λ could also induce HDV ribonucleic acid (RNA) decline in
      patients with CHD. Based on IFN-λ's more limited receptor distribution and previous data from
      studies involving treatment with IFN-λ in patients with hepatitis B virus (HBV) or hepatitis
      C virus (HCV), it is postulated that Lambda treatment could be associated with fewer adverse
      effects than IFN-α treatment. This Phase II study is designed as randomized, open-label study
      of Lambda 120 or 180 μg subcutaneous (SC) injection weekly for 48 weeks in patients with
      chronic HDV infection, and the primary objectives of the study are as follows:

        -  To evaluate the safety and tolerability of treatment with 2 dose levels of Lambda over a
           48-week treatment period.

        -  To evaluate the effect of treatment with 2 different doses of Lambda on HDV RNA levels.
    

Intervention name(s): Peginterferon Lambda-1A
Intervention type(s): Drug
Other intervention name(s): Lambda
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
TB Immunotherapy Trial With Heat-killed M. Vaccae
Condition: Tuberculosis
MeSH terms: Tuberculosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to carry out multi-country (Ukraine and Mongolia),
      placebo-controlled, randomized Phase III trial in patients with drug-sensitive, multi-drug
      resistant (MDR-TB) and TB-HIV and identify efficacy and safety of whole-cell, heat-killed
      Mycobacterium vaccae formulated as a pill (V7) and consequently conduct confirmatory trials
      in intended registration countries, such as China, Russia and South Africa, etc.
    

Detailed description: 
      Main end-point is negative sputum conversion rate after one month in patients on V7 vs
      placebo arm, both arms will receive conventional anti-tuberculosis chemotherapy consisting of
      1st and/or 2nd line TB drugs according to baseline diagnosis
    

Intervention name(s): V7; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): One pill of V7 once daily for 30 days together with standard of care TB drugs
Other intervention name(s): V7 or tableted heat-inactivated mycobacterium vaccae
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: M. vaccae; TB; MDR-TB; V7-immunitor
Acceptability of Lactacyd Femina
Condition: Hygiene
Study type: Interventional
Phase: Phase 4

Summary: 
      To demonstrate the safety and acceptability of the gynaecological formulation.
    


Intervention name(s): Lactic acid
Intervention type(s): Drug
Intervention description(s): Once a day
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Qualitative Analysis on the Experiences of Employment Among Schizophrenic Patients
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Observational

Summary: 
      The aim of this search is to realize the subjective experiences of employment among
      schizophrenic patients by qualitative analysis. We plan to recruit 50 people diagnosed with
      schizophrenia and divide into two groups, employment and unemployment. Every subjects will
      complete the demographic data, the evaluation of severity of disease, the record of
      medication and an intensive interview about their employment experiences. Finally, we will
      analysis the thick descriptions to understand how schizophrenic patients interpret their
      employment experiences and which factors will affect their successful employment.
    


Time perspective: Prospective
Study of the Effect of Oral Zinc Supplementation on Superoxide Radical Scavengers
Condition: Asthenozoospermia
MeSH terms: Asthenozoospermia
Study type: Interventional
Phase: Phase 2

Summary: 
      Although several studies have considered the relationship between infertility and semen super
      oxide radical scavengers levels, no study on the effects of asthenospermia treatments such as
      oral zinc supplementation on superoxide radical scavengers activity which are important in
      fertility of the individual has been reported.
    

Detailed description: 
      The present study was conducted to study the effect of zinc supplementation on the
      quantitative and qualitative characteristics of semen along with superoxide radical
      scavengers activity in the seminal plasma of asthenospermic patients.
    

Intervention name(s): zinc sulfate
Intervention type(s): Dietary Supplement
Intervention description(s): The subfertile group treated with zinc sulfate, every participant took two capsules of zinc sulfate per day for three months (each one 220 mg).
Intervention MeSH terms: Zinc Sulfate
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Zinc supplementation.; Oxidative stress.; Superoxide radical scavengers.; Asthenospermia.; Oxido-sensitive index.
Performance of Toric Hydrogel Lenses Following A Refit With Toric Silicone Hydrogel Lenses for 1 Month
Condition: Ametropia
MeSH terms: Refractive Errors
Study type: Interventional

Summary: 
      The aim of this prospective study is to evaluate the clinical performance of habitual wearers
      of methafilcon A toric lenses after a refit with fanfilcon A toric lenses for 1-month of
      daily wear.
    


Intervention name(s): methafilcon A toric contact lenses; fanfilcon A toric contact lenses
Intervention type(s): Device; Device
Intervention description(s): Bilateral daily wear of methafilcon A toric contact lenses; Bilateral daily wear of fanfilcon A toric contact lenses
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other