bioihbjkbjnl/mcl2 huggingface dataset:
A Bridging Study: Comparing Two Lots of Sci-B-Vac™ and Engerix-B in Healthy Adults
Condition: Hepatitis B
MeSH terms: Hepatitis B; Hepatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      This was a single-blind, 3-arm, comparative, controlled, randomized, study conducted at one
      site in Vietnam whose primary objective was to demonstrate clinical equivalence of the two
      production lots of Sci-B-Vac vaccine produced at two different facilities (OLD facility (Lot
      A) and NEW facility (Lot B) with respect to anti-hepatitis B-Surface (HBs) response.
      Secondary efficacy analysis was performed to demonstrate non-inferiority of seroprotection of
      each lot of Sci-B-Vac vaccine when compared to Engerix-B vaccine
    

Detailed description: 
      This was a single-blind, 3-arm, comparative, controlled, randomized, study conducted at one
      site in Vietnam. Following a screening period, healthy eligible subjects (n = 402) were
      enrolled and randomized to receive Sci-B-Vac (OLD facility (Lot A) and NEW facility (Lot B),
      or Engerix-B.

      The study was conducted in two stages, approximately a year-and-a-half apart. In the first
      stage (Stage I) beginning in March 2006, Sci-B-Vac (Lot A) vaccine was compared to Engerix-B;
      and in the second stage (Stage II) beginning in November 2007, the Sci-B-Vac (Lot B) vaccine
      was compared to Engerix-B. The subjects assigned to the Engerix-B group were equally divided
      between the stages, 67 subjects in the Engerix-B group in Stages I and II, respectively, for
      a total of 134 subjects, such that the final number of randomized subjects in Stage 1 and
      Stage 2 across the Sci-B-Vac Lot A, Sci-B-Vac Lot B and Engerix-B was 1:1:1, respectively.
      Immunogenicity evaluations for Stage I data (Visits 5 and 6) were conducted together with
      Stage II data.
    

Intervention name(s): Sci-B-Vac-Lot B; Sci-B-Vac-Lot A; Engerix-B
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Sci-B-Vac Lot B -10 μg of HBsAg, intramuscular injection of 10 μg/ml; Sci-B-Vac Lot A - 10 μg of HBsAg, intramuscular injection of 10 μg/ml; Engerix-B (hepatitis B vaccine (recombinant)) is indicated for active immunization against hepatitis B virus infection
Other intervention name(s): Sci-B-Vac; 3-antigen HepB Vaccine; Bio-Hep-B; Sci-B-Vac; 3-antigen HepB Vaccine; Bio-Hep-B
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Single blind, three-arm, two-stage, randomized study
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Sci-B-Vac; Prophylactic vaccine; Hepatitis B vaccines; Phase 3; pre-S1; pre-S2; Surface antigen; 3-antigen
Effect of Aged Garlic Extract (AGE) on Improving Coronary Atherosclerosis in People With Type 2 Diabetes Mellitus
Condition: Coronary Arteriosclerosis; Endothelial Dysfunction; Type 2 Diabetes Mellitus
MeSH terms: Atherosclerosis; Arteriosclerosis; Coronary Artery Disease; Myocardial Ischemia; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The purpose of this research study is to see the effect of taking Aged Garlic Extract (AGE)
      on the progression of coronary plaque, a condition called atherosclerosis, in people
      diagnosed with Diabetes.
    

Detailed description: 
      This clinical trial is to determine on progression rates of low attenuation plaque under
      influence of Aged Garlic Extract as compared to placebo over the 1year period in individuals
      with Type 2 Diabetes Mellitus.The study also examines the effect of Aged Garlic Extract on
      endothelial function and arterial stiffness which was measured by cardio-ankle vascular index
      (CAVI) over the 3months period.
    

Intervention name(s): Aged Garlic Extract (AGE); Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 2400mg of Aged Garlic Extract (AGE); Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double Blind Placebo Controlled
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: coronary artery disease; Endothelium
Radiofrequency-assisted Liver Resection in Intractable Liver Cancer
Condition: Liver Cancer
MeSH terms: Liver Neoplasms
Study type: Observational

Summary: 
      In this retrospective study, the investigators assessed the application of
      radiofrequency-assisted liver resection in intractable liver cancer resection, and plan to
      analysis the different factors.
    

Detailed description: 
      The primary clinical treatment of liver cancer is surgical resection, although many
      integrated applications develop rapidly, surgery is still the best way to remove the tumour
      lesion. Traditional ways that have curative removed tumours in three methods, which are liver
      resection, liver transplantation and radiofrequency ablation (RFA).

      As for primary liver cancer, surgery, and RFA are both effective and safety, but for the
      complexity of end-stage liver cancer, surgical resection may not remove the tumours alone.
      Surgical resection with radiofrequency ablation therapy for intractable liver cancer is a
      kind of active plan. The therapy can eliminate the tumour, maximize the protection of patient
      liver tissue, reduce operation damage, reduce the incidence of complications, and improve
      patients quality of life after surgery.
    

Intervention name(s): radiofrequency; TACE; TACE+radiofrequency
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): radiofrequency combined with liver resection; only TACE treatment; TACE followed by radiofrequency
Intervention MeSH terms: Chlorotrianisene
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        HCC patients
      
Keywords: RFA; liver cancer; surgical resection
Technical Failure During Colorectal Endoscopic Full Thickness Resection (EFTR): The "Through Thick and Thin" Study
Condition: Endoscopic Full Thickness Resection (EFTR); Residual /Recurrent Colorectal Lesion; Full-thickness Resection Device (FTRD); Colorectal Adenoma; Non-lifting Colorectal Lesions; Intraprocedural Complication
MeSH terms: Adenoma
Study type: Observational

Summary: 
      Among advanced resection techniques, endoscopic full thickness resection (EFTR) allows
      closure and full-thickness resection by the use of the non-exposed full thickness resection
      device (FTRD). The study is a retrospective analysis of technical failure occurring during
      colorectal full-thickness resection. Full thickness resection is a safe and effective
      procedure for "difficult" colorectal lesions. However, technical failure can occur and to
      date there is no evidence about type and clinical consequences in this setting.
    

Detailed description: 
      The study is a multicentre retrospective study involving centres with experience in advanced
      colorectal resections.

      Each centre is invited to submit information about the Centre and to report alle the
      consecutive cases corresponding to technical failure.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients undergoing colorectal EFTR with occurrence of technical failure.
The Effect of Ischemic Training on Exercise Endurance
Condition: Heart Failure; Congestive Heart Failure; Cardiovascular Disease
MeSH terms: Heart Failure; Cardiovascular Diseases
Study type: Interventional

Summary: 
      The purpose of this study is to determine if reducing blood flow to an exercising muscle
      during exercise training will enhance the training effect on that muscle in people who have
      limited exercise because of congestive heart failure
    

Detailed description: 
      The objective of this study is to determine whether reduction of blood flow during
      stair-stepping and cycling ergometer leg exercise will contribute to an improvement in whole
      body exercise capacity or submaximal exercise endurance in patients with mild congestive
      heart failure. Two groups of 25 patients with mild to moderate CHF, aged 30-70, will be
      trained for 12 weeks. The experimental group will train with pressure cuffs inflated on one
      thigh and lower leg during exercise. The cuff will be applied on alternate legs during
      training, such that each leg has the same duration of ischemic training. The control group
      will train for a similar duration and intensity without pressure cuffs on the legs. Pre and
      post training measures will include VO2peak, exercise duration at 30% VO2peak, 6 minute walk
      test, Minnesota Living with Heart Failure questionnaire
    

Intervention name(s): Ischemic exercise training
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Keywords: Exercise; Exercise Therapy
Effect of Probiotics on Gut-Liver Axis of Alcoholic Liver Disease
Condition: Alcoholic Liver Disease
MeSH terms: Liver Diseases; Liver Diseases, Alcoholic
Study type: Interventional
Phase: Phase 4

Summary: 
      Background/Aims:

      The investigators explored the therapeutic effects of probiotics in patients with AH.

      Methods:

      Between September 2010 and April 2012, the investigators conducted a 7-day,
      double-controlled, randomized, prospective clinical trial comparing the efficacy of
      probiotics in improving liver enzymes, LPS, pro-inflammatory cytokines. AH was defined as an
      aspartate aminotransferase (AST)/alanine aminotransferase (ALT) > 2 and elevated AST (ALT)
      level with an alcohol consumption history within 48 hours. Patients were randomized to
      receive 7 days of probiotics (1500 mg/day) or placebo. The levels of liver enzymes, modified
      Discriminant Function (mDF), LPS, and pro-inflammatory cytokines were checked at baseline and
      again after therapy.
    

Detailed description: 
      Background/Aims: Alcoholic hepatitis (AH) is one of the leading causes of liver diseases.
      Gut-derived microbial lipopolysaccharide (LPS) has been known as a central role in the
      pathogenesis of AH. Some animal studies suggested an emerging role of probiotics in
      restoration of the bowel flora and improving liver enzymes. We explored the therapeutic
      effects of probiotics in patients with AH.

      Methods: Between September 2010 and April 2012, we conducted a 7-day, double-controlled,
      randomized, prospective clinical trial comparing the efficacy of probiotics in improving
      liver enzymes, LPS, pro-inflammatory cytokines. AH was defined as an aspartate
      aminotransferase (AST)/alanine aminotransferase (ALT) > 2 and elevated AST (ALT) level with
      an alcohol consumption history within 48 hours. Patients were randomized to receive 7 days of
      probiotics (1500 mg/day) or placebo. The levels of liver enzymes, modified Discriminant
      Function (mDF), LPS, and pro-inflammatory cytokines were checked at baseline and again after
      therapy.
    

Intervention name(s): hepatitis, alcohol, probiotics; alcohol, hepatitis, Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 7 days of probiotics (1500 mg/day); Placebos of the same shape and size were manufactured at Pharmaceutical Corporation.
Other intervention name(s): LACTOWELL; Placebo
Intervention MeSH terms: Ethanol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: hepatitis, alcohol
APOSTrophe Study (Parenteral Nutrition and Bone Trophicity) Impact of a Long-term Parenteral Nutrition on Bone Metabolism Measured by High Resolution Peripheral Quantitative Computer Tomography (HR-pQCT) in Children and Young Adults
Condition: Long-term Parenteral Nutrition (2 Years) in Children and Adults
Study type: Interventional

Summary: 
      Recent progress in parenteral nutrition has contributed to improve vital prognosis and to
      reduce morbidity in patients with severe intestinal failure.

      Currently, home parenteral nutrition is the only alternative to prolonged hospitalization for
      those patients. However, long-term parenteral nutrition can result in complications
      especially in bone, such as osteopenia or osteomalacia, then increasing the risk of
      fractures. Children are especially at risk because of bone growth and peak mineralization
      acquisition during puberty.

      Moreover, frequency and risk factors of those complications are not well documented for
      children.

      Dual-energy X-ray Absorptiometry (DXA) is considered as the golden standard for bone
      mineralization measurement. In pediatrics, this technique has some limits such as the
      underestimation of Bone Mineral Density (BMD) in short stature, the overestimation of the BMD
      in tall children, and the inability to distinguish cortical from trabecular bone or to
      evaluate the bone microarchitecture.

      HR-pQCT, High Resolution peripheral Quantitative Computed Tomography enables noninvasive
      assessment of bone microarchitecture (virtual bone biopsy) using a radiation similar to DXA.
      However this technique has never been validated in patients with long-term parenteral
      nutrition.

      During the usual follow-up of the patients, HR-pQCT will be the only exam which will come in
      addition to the routine medical tests.
    


Intervention name(s): HR-pQCT
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Long-term parenteral nutrition; HR-pQCT; DXA; Bone trophicity
Explorative Study of AZD1305 in Atrial Fibrillation Patients
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional
Phase: Phase 2

Summary: 
      Explorative study in Atrial Fibrillation patients to assess Safety and Pharmacokinetics at
      initiation of treatment and at steady state
    


Intervention name(s): AZD1305; AZD1305; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): AZD1305 loading dose 250 mg + 125 mg evening dose on Study Day 1, maintenance dose 125 mg twice daily from Study Day 2; AZD1305 loading dose 500 mg + placebo evening dose on Study Day 1, maintenance dose 125 mg twice daily from Study Day 2; Placebo corresponding to AZD1305 loading dose + evening dose on Study Day 1, maintenance dose twice daily from Study Day 2
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
YOGA Asanas and Myofascial Chain Activity in Elderly Individuals
Condition: Geriatrics
Study type: Interventional

Summary: 
      Aging is a differentiation process with chronological, biological, psychological and social
      characteristics, which occurs in the intrauterine period and ends with death. With aging, the
      structures and functions of tissues are affected and there is a decline in overall physical
      performance. Asanas in yoga use tonic muscle contraction coordinated with breath control and
      kinesthetic awareness, which saves energy compared to phasic muscle contraction often
      observed in physical exercises. We have not encountered a study examining the effect of
      asanas on muscular activity in old age. Our study will provide support to the literature in
      this direction.
    

Detailed description: 
      The study will be carried out on volunteers after the approval of the ethics committee.
      Before the research, individuals and / or their relatives will be informed about the purpose
      and content of the study. Participants will first start in mountain (Tadasana) asana. They
      will then be asked to come to the following asanas in a randomized order. In each of the
      asanas, you will statically pause for 15 seconds and repeat the movement three times.
      Participants will rest for 2 minutes between asanas. If deemed necessary during the
      application, modifications will be made in the movements and security measures will be taken.
      Warrior 2, elongated triangle, and Light Cluster stances will be evaluated for each limb
      separately. Muscle activations of individuals to the contralateral external oblique abdominal
      and ipsilateral adductor longus muscles of the anterior oblique myofascial chain lines and
      the contralateral latissimus dorsi and ipsilateral biceps femoris long head muscles to the
      posterior oblique myofascial chain lines will be evaluated using superficial EMG.
    

Intervention name(s): YOGA
Intervention type(s): Other
Intervention description(s): Five different YOGA Asana's will made randomly
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of LY2623091 in Male and Females With Chronic Kidney Disease
Condition: Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this trial is to investigate the safety and efficacy of LY2623091 in males and
      females with chronic kidney disease.
    

Detailed description: 
      This trial consists of 4 treatment arms: 3 LY2623091 dose levels and eplerenone. Each
      participant will participate in 2 treatment periods, with a minimum wash-out period of 28
      days between dosing in the 2 treatment periods. Dosing days will be numbered 1-21 in each of
      the 2 treatment periods. Participants will receive different treatments in periods 1 and 2.
      Participants will be housed as inpatients during the days of the controlled diet
      administration and the oral potassium challenge and until at least 24 hours after its
      completion (Days -3 to 1; Days 19 to 22, in each treatment period). Otherwise the study will
      be done on an outpatient basis, with participants returning to the clinic for evaluations
      during each treatment period (Days 3 or 4, 7, and 14).
    

Intervention name(s): LY2623091; Eplerenone
Intervention type(s): Drug; Drug
Intervention description(s): Administered orally; Administered orally
Intervention MeSH terms: Eplerenone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Sarcopenic Obesity in Neurodisabilities
Condition: Sarcopenic Obesity; Spinal Cord Injuries; Stroke; Multiple Sclerosis; Traumatic Brain Injury
MeSH terms: Multiple Sclerosis; Brain Injuries; Spinal Cord Injuries; Brain Injuries, Traumatic; Obesity; Wounds and Injuries
Study type: Observational

Summary: 
      To describe the frequency and thresholds for sarcopenic obesity in neurodisabled persons and
      the fat and lean mass distribution based on various neurodisabilities
    


Intervention name(s): whole body DXA
Intervention type(s): Diagnostic Test
Intervention description(s): Measurements of body composition may be used to study how lean body mass and body fat change during health and disease and have provided a research tool to study the metabolic effects of obesity and various wasting conditions. DXA measurements are based in part on the assumption that the hydration of fat-free mass remains constant at 73%.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Persons with neurodisability, men and women in comparison with able-bodied controls.
        Controls considered healthy after physical examination and comprehensive medical history
        review, which was free of any previous fracture ,endocrine or metabolic bone disease,
        malignancy, drug abuse, alcoholism and hepatic or renal disorders.
      
Keywords: Sarcopenia; sarcopenic obesity; stroke; sci; TBI; MS
Bioequivalence Study to Compare Two Tablets of Ivermectin Tablets (3 mg Ivermectin) Versus Two Tablets of Stromectol ® Tablets (3 mg Ivermectin), in Healthy Subjects Under Fasting Conditions
Condition: Anthelmintic Agent
Study type: Interventional
Phase: Phase 1

Summary: 
      Randomized, two-way, two-period, single oral dose, open-label, crossover, bioequivalence
      study to compare two tablets of Ivermectin tablets (3 mg Ivermectin) versus two tablets of
      Stromectol ® tablets (3 mg Ivermectin), in healthy subjects under fasting conditions.
    


Intervention name(s): Ivermectin tablets (3 mg Ivermectin); Stromectol ® tablets
Intervention type(s): Drug; Drug
Intervention description(s): Two Ivermectin tablets were administered orally.; Two Ivermectin tablets were administered orally.
Intervention MeSH terms: Ivermectin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
New Techniques to Reduce Intra-operative Bleeding During Complex Liver Resection
Condition: Surgical Blood Loss
MeSH terms: Blood Loss, Surgical
Study type: Observational [Patient Registry]

Summary: 
      This observational study introduced an new advanced bleeding control strategy during complex
      liver resection.This newly described "stepwise vascular control" technique was efficacious
      and feasible to control intra-operative bleeding in complex hepatectomy involving second
      hepatic hilum and retro-hepatic inferior vena cava.
    


Intervention name(s): stepwise vascular control
Intervention type(s): Procedure
Intervention description(s): Before liver parenchymal resection, we performed "total hepatic vascular preparation for occlusion" with portal triad (PT), infra-hepatic inferior vena cava (IIVC), and supra-hepatic inferior vena cava (SIVC) preparation in order. Then we performed step-by-step vascular occlusion according to the individual bleeding situation.
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Consecutive patient sampling according to the eligibility criteria
Intraoperative Sedatives and Postoperative Pain
Condition: Arthritis, Degenerative
MeSH terms: Osteoarthritis; Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      In this study, based on the hypothesis that dexmedetomidine administered intraoperatively for
      sedation can reduce postoperative pain than that of propofol, the investigators examined the
      ability of dexmedetomidine to reduce postoperative pain in in patients undergoing the total
      knee arthroplasty.
    


Intervention name(s): Dexmedetomidine; Propofol
Intervention type(s): Drug; Drug
Intervention description(s): Intraoperative sedation using dexmedetomidine; Intraoperative sedation using propofol
Intervention MeSH terms: Dexmedetomidine; Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Dexmedetomidine; Propofol; Pain, Postoperative