bioihbjkbjnl/mcl2 huggingface dataset:
Alpha-lipoic Acid Reduces Left Ventricular Mass in Normotensive Type 2 Diabetic Patients With Coronary Artery Disease
Condition: Type 2 Diabetes; Coronary Artery Disease; Left Ventricular Mass
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      Cardiovascular complications account for the highest mortality in type 2 diabetic patients,
      mainly due to coronary artery disease (CAD). Most of the attention in treating CAD in type 2
      diabetes is understandably directed toward treating coronary artery conditions. However there
      are other treatable culprits in these patients.

      Left ventricular hypertrophy (LVH) is widespread in type 2 diabetic patients with CAD, even
      in the absence of hypertension. It is a strong predictor of cardiovascular events and
      all-cause mortality. Regression of LVH has been associated with an improved prognosis,
      independent of change in blood pressure (BP). Therefore, cardiovascular events and mortality
      in type 2 diabetes with CAD might will be reduced if the investigators can find novel
      therapies to regress LVH.

      Alpha-lipoic acid reduces oxidative stress which then regresses LVH. Alpha-lipoic acid can
      improve endothelial function in diabetic conditions. Hence, the main aim of this study was to
      assess whether alpha-lipoic acid could regress LVM in type 2 diabetic patients with CAD.
    


Intervention name(s): alpha-lipoic acid
Intervention type(s): Drug
Intervention MeSH terms: Thioctic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Robot-assisted vs VATS Lobectomy for NSCLC
Condition: Pulmonary Neoplasm
MeSH terms: Lung Neoplasms
Study type: Interventional

Summary: 
      Robot-assisted thoracoscopic surgery (RATS) was widely used in thoracic surgery, the surgical
      safety and feasibility of RATS lobectomy for NSCLC has been confirmed. However, the
      oncological long-term outcomes of RATS lobectomy has not been studied by randomized
      controlled trial, the purpose of this study is to determine whether RATS lobectomy would be
      as effective as VATS lobectomy on short-term and long-term outcomes.
    

Detailed description: 
      Video-assisted thoracoscopic surgery (VATS) lobectomy is recommended for non small cell lung
      cancer (NSCLC) with surgical indications in China, its oncological long-term outcomes has
      been widely approved. As a new form of VATS, robot-assisted thoracoscopic surgery (RATS) was
      widely used in thoracic surgery, the 3D vision and flexible robot arm were helpful for
      surgeons to perform precise operations, and RATS was reported to bring extra benefits to
      patients. The surgical safety and feasibility of RATS lobectomy for NSCLC has been confirmed.
      However, the oncological long-term outcomes of RATS lobectomy has not been studied by
      randomized controlled trial. so we designed this randomized controlled trial to determine
      whether RATS lobectomy would be as effective as VATS lobectomy on short-term and long-term
      outcomes.
    

Intervention name(s): VATS lobectomy; RATS lobectomy
Intervention type(s): Procedure; Procedure
Intervention description(s): a minimal invasive surgical types for NSCLC: VATS lobectomy; a minimal invasive surgical types for NSCLC: RATS lobectomy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: lobectomy; robot-assisted thoracoscopic surgery; lung cancer
A Study to Evaluate the Efficacy of E-PR-01 on Musculoskeletal Health in Physically Active Individuals
Condition: Joint Pain
MeSH terms: Arthralgia
Study type: Interventional

Summary: 
      The present study is a randomized, placebo-controlled, parallel-group, double-blind
      (double-dummy) clinical study. Not more than 210 individuals will be screened, and
      considering a screening failure rate of 18%, approximately 168 participants will be
      randomized in a ratio of 1:1:1 to receive E-PR-01 (LD: 200 mg/day), E-PR-01 (HD: 400 mg/day),
      or placebo (400 mg/day). After accounting for a dropout/withdrawal rate of 15%, each group
      will have at least 48 completed participants with equal numbers of participants having knee
      and lumbo-sacral as index joint. The intervention duration for all the study participants
      will be approximately 90 days.
    


Intervention name(s): E-PR-01 (Low dose); E-PR-01 (High Dose); Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): One Capsule to be consumed twice a day; One Capsule to be consumed twice a day; One Capsule to be consumed twice a day
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, Parallel Group, Placebo Controlled Trial
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other
Influence of Daylong Glycemia on Detraining Induced Metabolic Changes
Condition: Healthy
Study type: Interventional

Summary: 
      Aim of the study is to investigate the impact of glycemic index (provided as soft drinks) on
      changes in insulin sensitivity, metabolic flexibility, and arterial stiffness in response to
      detraining.

      The investigators hypothesize that low glycemic soft drinks decrease the detraining-induced
      impairment of insulin sensitivity, metabolic flexibility and arterial stiffness.
    

Detailed description: 
      The duration of the study is 7 weeks: two x 2 weeks intervention (phase A and phase B) with 3
      weeks washout phase inbetween. Each 2-week intervention phase consists of an active week
      followed by an inactive week.

      in phase A subjects consume high GI (maltodextrin and sucrose) soft drinks during the
      inactive week. In phase B subjects consume a low GI soft drink (palatinose) during the
      inactive week.

      subjects were randomly assigned to either start with phase A or with phase B (cross over
      design).

      During the whole study duration all food is provided (55% CHO, 30% fat, 15% protein)

      Physical activity will be assessed by a step counter (active phase 7000-10000 steps/d and
      inactive phase 3000-4000 steps/d).
    

Intervention name(s): soft drinks
Intervention type(s): Dietary Supplement
Intervention description(s): soft drinks with palatinose and maltodextrin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: glycemic index; inactivity; insulin sensitivity; metabolic flexibility; arterial stiffness; young men
A Study to Assess the Nicotine Pharmacokinetics, Tolerability and Safety With a New Oral Nicotine Replacement Product in Healthy Japanese Smokers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      In Part 1, the purpose of this study is to elucidate the single-dose pharmacokinetic profiles
      of 1 spray and 2 consecutive sprays of oromucosal nicotine spray (ONS) in comparison with
      those of nicotine gum and cigarette smoking in healthy Japanese smokers. In Part 2, the
      purpose is to evaluate the multiple-dose nicotine pharmacokinetics of ONS administered
      repeated-dose administration in healthy Japanese smokers.
    


Intervention name(s): Oromucosal Nicotine Spray (ONS); Nicotine Gum; Cigarette
Intervention type(s): Drug; Drug; Other
Intervention description(s): Participants will receive oral dose of oromucosal nicotine spray (ONS).; Participants will chew nicotine gum for 30 minutes.; Participants will smoke one cigarette as 10 puffs for 3 minutes.
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Effects of Simvastatin on Biomarkers
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      A year-long randomized, double-blind, placebo-controlled trial of simvastatin to see if it
      produces beneficial changes in cerebral spinal fluid proteins associated with Alzheimer's
      disease.
    

Detailed description: 
      The purpose of this study is to see if a drug called simvastatin (brand name Zocor)
      beneficially affects the level of certain molecules (such as proteins) in the spinal fluid of
      people. The molecules the investigators are measuring are thought to be important in the
      development of Alzheimer's disease (AD), and the investigators are testing whether
      simvastatin can change proteins to a level that is associated with a reduced risk for AD.

      Simvastatin has been approved by the United States Food and Drug Administration (FDA) for the
      treatment of high cholesterol and to reduce the risk of coronary artery disease. It is an
      investigational drug in this study.

      Participants will be randomly assigned to Placebo or Simvastatin. The investigators and the
      participant will be blinded. Randomization will be stratified by age and gender.

      This study is being funded by the National Institute on Aging. The investigators will take
      part in this study at the VA Puget Sound Health Care System.

      This study will last up to 1 year. Participants will be asked to come to the VA in Seattle a
      total of 9 times, 2 of those times will be for lumbar punctures (also known as a spinal tap).

      The investigators would also like to ask a person who knows the participant well (such as a
      spouse, child, sibling, or good friend) some questions about the participant's health,
      memory, mood and behavior, and abilities to do daily tasks at the beginning and the end of
      the study.

      Participants must be cognitively normal, healthy, willing to have a lumbar puncture, and not
      need or take any medications to control cholesterol.
    

Intervention name(s): Simvastatin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Simvastatin 40mg qHS for 1 year; Placebo 1 tablet qHS for 1 year
Other intervention name(s): Zocor; Sugar Pill
Intervention MeSH terms: Simvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Alzheimer's Disease; Prevention; Spinal Fluid; Biomarkers; Simvastatin
Study of PEMF to Evaluate VPT and Thermal Sensory in Subjects With Diabetic Peripheral Neuropathy
Condition: Diabetic Peripheral Neuropathy
MeSH terms: Peripheral Nervous System Diseases; Diabetic Neuropathies
Study type: Interventional

Summary: 
      A study to demonstrate the effectiveness of PEMF treatment compared to sham treatment in
      changing Vibration Perception Threshold (VPT) and Thermal Sensory (QST) in patients with
      diabetic peripheral neuropathy (DPN) when treatment is administered twice daily through
      120-day period.
    

Detailed description: 
      Multi-center, sham-controlled, double-blind, enriched enrollment, randomized withdrawal
      clinical trial conducted on subjects with bilateral symmetrical diabetic peripheral
      neuropathy. Eligible subjects will include those between 22 and 80 years of age with Type 1
      or Type 2 diabetes having persistent pain, numbness, tingling, or burning in both feet
      despite treatment. Eligible subjects will receive two active treatment devices (one for each
      foot, to allow simultaneous treatment) and treat at home, twice daily for 60 days after which
      they will return to the clinic at Day 61 for a response assessment. Subjects that are
      determined to be responders at Day 61 (subjects that achieve a 1-point decrease in the
      average pain score over the last 24 hours using the Numeric Pain Rating Scale (NPRS)) will be
      randomized 1:1 to either active treatment or inactive sham devices and will continue treating
      through Day 120. Subjects that are determined to be non-responders at Day 61 will continue
      treating with the active devices given at enrollment and will return to the clinic at Day 75
      and Day 91 for a response assessment. If a subject is determined to be a responder at Day 75,
      they will be randomized 1:1 to receive either active treatment or inactive sham and will
      continue treating through Day 120. If a subject is determined to be a responder at Day 91,
      they will be randomized 1:1 to receive either active treatment or sham and will continue to
      treat through Day 120. If a subject continues to be a non-responder at Day 91 they will be
      terminated from the study.
    

Intervention name(s): Active Provant Therapy System; Inactive (sham) Provant Therapy System
Intervention type(s): Device; Device
Intervention description(s): Treatment with active Provant Therapy System; Treatment with Inactive (sham) Provant Therapy System
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects deemed "responders" after active treatment will be randomized in a 1:1 ratio to either active treatment or a sham device.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Open Label Crossover Study Pharmacokinetics (PK) Study in Healthy Volunteers Receiving Various Forms of Fentanyl
Condition: Healthy
Study type: Interventional
Phase: Phase 4

Summary: 
      A partially randomized, open-label, 3-way crossover, single-center, systemic and CSF PK and
      bioavailability study in healthy volunteers.
    

Detailed description: 
      An Open-Label Single-Dose Crossover Study Comparing the Plasma and Cerebrospinal Fluid
      Pharmacokinetics and Bioavailability of Fentanyl Delivered Intranasally Versus Sublingually
      Versus Intravenously in Healthy Volunteers
    

Intervention name(s): Fentanyl
Intervention type(s): Drug
Intervention description(s): Lazanda (nasal spray), Subsys (sub-lingual) and intravenous fentanyl
Other intervention name(s): Lazanda, Subsys, IV fentanyl
Intervention MeSH terms: Fentanyl
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Volunteer; Pharmacokenetics (PK) (plasma and Cerebrospinal Fluid [CSF])
Effectiveness of Five Intraarticular Strategies on Knee Osteoarthritis
Condition: Osteo Arthritis Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      BACKGROUND: Current medical treatment strategies for knee osteoarthritis (OA) are aimed at
      pain reduction and symptom control. The Non-Arthroscopic Joint Lavage (NAJL) is included
      inside the therapeutic algorithm of knee OA when other therapies are contraindicated or have
      lost effectiveness. The large variety of potentially invasive interventions available (joint
      lavage included) has raised the need to assess their efficacy. The objective of this study is
      to compare the short-term effectiveness of five treatment strategies in patients with knee
      osteoarthritis (OA).

      METHODS: It was conducted a randomized prospective study involving 150 patients of whom 76.7%
      were females. The age range was 40-81 years. All patients had knee OA according to the
      American College of Rheumatology criteria, with Kellgren-Lawrence radiographic grades II and
      III. Patients were assigned to five groups, 1) non-arthroscopic joint lavage (NAJL) (n= 30),
      2) NAJL plus hyaluronic acid (HA) (n= 32), 3) NAJL plus corticosteroid (CS) (n= 32), 4) HA
      (n= 31), 5) CS (n= 25). Evaluations took place at baseline, one and three months after
      enrollment. Demographic variables, Western Ontario and McMaster University Osteoarthritis
      Index (WOMAC) and Lequesne scores were recorded. Statistical analysis included mixed analysis
      of variance, post-hoc comparisons with Sidak's adjustment, and multiple linear regression
      using as outcome WOMAC total at 3 months.

      TRIAL REGISTRATION: The protocol of the study was approved by the "Hospital Universitario
      Reina Sofía" Ethics Committee, under the number 1996, in the Minutes 208 of 29 May 2012.
    


Intervention name(s): Non arthroscopic joint lavage; Non arthroscopic joint lavage plus corticosteroid; Non arthroscopic joint lavage plus hyaluronic acid; Intraarticular injection of corticosteroid; Intraarticular injection of hyaluronic acid
Intervention type(s): Procedure; Procedure; Procedure; Procedure; Procedure
Intervention description(s): Instillation of 4 litters of cold physiological serum; Instillation of 4 litters of cold physiological serum followed by intraarticular injection of triamcinolone; Instillation of 4 litters of cold physiological serum followed by intraarticular injection of hyaluronic acid; Intraarticular injection containing 40 mg of triamcinolone acetonide.; Intraarticular injection containing 4 mL of a bioengineered hyaluronic acid.
Other intervention name(s): NAJL
Intervention MeSH terms: Hyaluronic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Open, controlled, randomized and prospective study.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Corticosteroid; Hyaluronic acid; Joint Lavage
Long-Term Outcomes of LSG in Pediatric Patients
Condition: Obesity, Childhood; Bariatric Surgery Candidate; Cardiovascular Risk Factor
MeSH terms: Pediatric Obesity
Study type: Observational [Patient Registry]

Summary: 
      This project aims to assess the short- and long-term safety and efficacy of bariatric surgery
      in children and adolescents compared to adults.
    

Detailed description: 
      Obesity affects children and adults across all age groups. More than 30% of children and
      adolescents in the United States are currently overweight or obese, whereas the prevalence of
      obesity is as high as 21.4% in young children.This increase in prevalence is associated with
      significant short- and long-term health implications and necessitates effective interventions
      that induce significant weight loss and ameliorate associated conditions.

      The results of weight loss surgery in children and adolescents are still scarce, despite
      recent studies suggesting favorable short- and intermediate-term outcomes that are comparable
      to those in adults. Although evidence continues to emerge, this solution is still denied to
      young children.

      Bariatric surgery has proven safety and efficacy in inducing significant weight loss and
      co-morbidity resolution in children and adolescents. However, long-term evidence in this age
      group is yet to be reported. This project aims to study long-term weight loss, cardiovascular
      risk factors, growth and morbidity in severely obese children and adolescents (aged 5-21
      years) who undergo laparoscopic sleeve gastrectomy (LSG).

      This study aims to narrow the current evidence gap by studying the long-term effects of
      bariatric surgery in children and adolescents with severe obesity.
    

Intervention name(s): Sleeve gastrectomy
Intervention type(s): Procedure
Intervention description(s): Laparoscopic sleeve gastrectomy
Other intervention name(s): Vertical Sleeve Gastrectomy
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children and adolescents who meet the inclusion criteria, fail to lose weight under an
        intensive family-based nutrition and lifestyle program, who signed an informed consent to
        participate in the study.
      
Biospecimen description: 
      Serum, plasma, subcutaneous and visceral fat, and liver samples obtained from patients who
      consent to have sample storage in liquid nitrogen for research purposes.
Diagnostic Performance of Smart Supra Perimetry (The DPSSP Study)
Condition: Glaucoma, Suspect; Glaucoma
MeSH terms: Glaucoma; Ocular Hypertension
Study type: Interventional

Summary: 
      Early glaucomatous visual field changes can be missed with the routinely used Standard
      Automated Perimetry (SAP) and the 24-2 test pattern due to limited sampling of the central 10
      degrees. While this shortcoming can be overcome with the addition of a 10-2 test, performing
      both tests places extra demand on the perimetric services (doubling test times) and patients.

      Smart Supra Perimetry (SSP) uses a new faster algorithm that can complete both 24-2 and 10-2
      test patterns in a similar time frame to a single 24-2 SAP test. This comparative study aims
      to determine the sensitivity and specificity (i.e. diagnostic accuracy) of SSP in identifying
      early glaucomatous visual field loss. A sample of 100 patients with early/suspect glaucoma
      will undergo SAP 24-2 and 10-2 (SITA algorithm) using Humphrey visual field perimetry and SSP
      24+10-2 using Henson 9000. Eyes will be categorised into 2 groups i.e., glaucoma and
      non-glaucoma, on the basis of structural changes to the disc as evaluated by the clinician.
      The sensitivity and specificity of the SAP and SSP tests will be established along with test
      duration. The size and location of defects established with both the SAP and SSP strategies
      will also be compared.
    


Intervention name(s): Humphrey Visual Field Test; Optical Coherence Tomography (OCT) Scan; Smart Perimetry - Henson 9000
Intervention type(s): Diagnostic Test; Diagnostic Test; Diagnostic Test
Intervention description(s): SITA Standard and 24-2 and 10-2 visual field tests; Circle and Wide Angle Scans; 24+10-2 Smart Supra test
Allocation: Randomized
Intervention model: Factorial Assignment
Intervention model description: All participants will have the same examinations but in a randomised order, these examinations are: Humphrey Visual Fields Test (10-2 and 24-2, SITA Standard), OCT Scan (Cube scan, Wide angle and macula scan) and Smart Perimetry - Henson 9000.
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: glaucoma
BOTOX® Economic Spasticity Trial (BEST)
Condition: Muscle Spasticity
MeSH terms: Muscle Spasticity
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a study to investigate if patients who have had a stroke and suffer from spasticity
      might benefit from being given BOTOX® in addition to the normal Standard Care. Spasticity is
      characterized by stiffness or frequent cramps accompanied by pain and abnormal movements and
      can prevent the carrying out of everyday tasks such as walking and getting dressed. BOTOX® is
      a neurotoxin, which is used to prevent the contraction of muscle fibre and has been shown to
      reduce spasticity significantly. Patients will be enrolled in this study at about 33
      locations in Europe and Canada. Study participation will last for about 1 year.
    


Intervention name(s): Botulinum Toxin Type A 900kD; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): The exact dosage and number of injection sites is based on the size, number, and location of muscles involved; the severity of spasticity; and the presence of local muscle weakness.
First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.; The exact dosage and number of injection sites is based on the size, number, and location of muscles involved; the severity of spasticity; and the presence of local muscle weakness.
First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
Other intervention name(s): BOTOX®
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment