bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Retaron® on Oxygen Induced Retinal Vasoconstriction in LPS Induced Inflammatory Model in Humans
Condition: Imparied Retinal Vascular Reactivity; Healthy Subjects
Study type: Interventional

Summary: 
      Oxidative stress has been implicated to play a pathogenic role in many disease processes,
      especially in age-related disorders such as age-related macular degeneration. It has been
      hypothesized that antioxidative agents such as vitamins and minerals, which are capable of
      scavenging free radicals, may reduce oxidative stress and may, in turn, be beneficial for
      patients with age-related disorders. Based on this hypothesis several different combinations
      of vitamins have been introduced, all targeting at reducing oxidative stress. However, the
      in-vivo effect of the antioxidative properties of a certain drug or vitamin combination is
      hard to investigate. In the current study, we propose to investigate the effect of Retaron®,
      a combination of carotoinoids, omega-3-fatty acids, a herbal extract of Aronia, vitamins and
      trace elements, in a systemic in-vivo inflammation model.

      In the present study, the infusion of LPS, which is a cell wall component of gram-negative
      bacteria and a major mediator in the pathogenesis of septic shock, will be used as a
      standardized experimental model of systemic inflammation in humans. Given that inflammation
      is associated with enhanced oxidative stress and widespread endothelial dysfunction, the LPS
      model is well suitable for determination of the antioxidative effects of Retaron®. As a main
      outcome parameter the vascular reactivity of retinal vessels to systemic hyperoxia (induced
      by breathing 100% oxygen) will be tested in presence or absence of the antioxidant
      combination.
    


Intervention name(s): Escherichia coli Endotoxin; Retaron®; Placebo
Intervention type(s): Drug; Dietary Supplement; Other
Intervention description(s): dose: 2 ng/kg bodyweight (corresponding to 20 IU/kg), i.v. bolus on both study days.; Dosage 1 capsule Retaron® per day.: Lutein 10mg, Zeaxanthin 2mg, Fishoil 500mg (with 250 mg DHA, 30 mg EPA), Vitamin C 100mg, Zinc 10mg, Selen 25µg, Vitamin E 25mg, Taurin 50mg, Aroniaextract 50mg, administered for 14 days; Placebo capsules identical in appearance to Retaron capsules
Other intervention name(s): LPS, US Standard Reference Endotoxin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Effect of Retaron on imparied retinal vascular reactivity after LPS administration in healthy subjects
Perioperative Goal Directed Therapy (PGDT) in Spinal Surgery in the Prone Position
Condition: Intraoperative Hypotension; Pulmonary Complication; Cardiovascular Complication
MeSH terms: Hypotension
Study type: Observational

Summary: 
      This study aims at evaluating if a specific protocol, that can be framed in the innovative
      concept of Perioperative Goal Directed Therapy (PGDT), based on the evaluation of the Stroke
      Volume Variation (SVV) - a parameter deriving from the adoption of a minimally invasive
      advanced hemodynamic monitoring technology with a special sensor called FloTrac® (Edwards) or
      of a non-invasive monitoring system with the Clearsight® sensor (Edwards) - is able to
      guarantee a greater precision in the intraoperative management of patients undergoing spinal
      surgery in prone position.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        44 Patients undergoing spinal surgery in prone position at "Gaspare Rodolico Presidium" of
        Policlinico-Vittorio Emanuele University Hospital of Catania, in which a specific protocol,
        that can be framed in the innovative concept of Perioperative Goal Directed Therapy (PGDT),
        based on the evaluation of the Stroke Volume Variation (SVV) by using a minimally invasive
        advanced hemodynamic monitoring technology with a special sensor called FloTrac® (Edwards)
        o a non-invasive monitoring system with Clearsight® sensor (Edwards), is used.
      
Keywords: Spinal Surgery
A Trial to Investigate the Single Dose Pharmacokinetics of Insulin Degludec/Liraglutide Compared With Insulin Degludec and Liraglutide in Healthy Chinese Subjects
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of the trial is to compare the bioavailability (extent of drug absorption
      into the circulation) of insulin degludec and liraglutide as part of a combination product
      insulin degludec/liraglutide compared to the corresponding doses of single, separate
      injections of insulin degludec and liraglutide. Participants will receive all three test
      substances. The order of trial administration will be allocated by chance. During the trial
      period, serials of blood samples will be collected from the participants at three dosing
      periods, in order to determine the concentration of insulin degludec and liraglutide. The
      total volume of blood taken throughout the whole trial period will be less than 400 mL.
      Participants will be asked to stay on daytime and overnight in the trial sites on some
      predefined days. For other outpatient days, participants need to attend the trial site as
      required for drug administration or required assessments.
    


Intervention name(s): insulin degludec/liraglutide; insulin degludec; liraglutide
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Insulin Degludec/Liraglutide combination product with 0.61 mg Liraglutide and 17 U Insulin Degludec, single dose administration under the skin in the thigh.; 17 U Insulin Degludec, single dose administration under the skin in the thigh.; 0.6 mg Liraglutide, single dose administration under the skin in the thigh
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Liraglutide; Insulin, Long-Acting; Xultophy
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Three-period complete cross-over, six treatment sequences
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Physical and Chemical Study of Atherosclerosis Mechanisms
Condition: Myocardial Infarction; Coronary Artery Diseases; Diabetes Mellitus, Type 2; Atherosclerosis of Femoral Artery
MeSH terms: Coronary Artery Disease; Myocardial Infarction; Atherosclerosis; Diabetes Mellitus, Type 2; Infarction
Study type: Interventional
Phase: Phase 4

Summary: 
      Study the mechanisms of atherosclerosis based on a comparative study of physical and chemical
      properties of lipid tissues at various localization with subsequent development of concept of
      treatment and prevention.
    

Detailed description: 
      The chemical and physical properties of different lipids of body. The clinical part of the
      work is a prospective randomized comparative controlled clinical trial of patients with
      atherosclerotic diseases.

      Developed the concept of "limited biological resources" of the body based on the increase in
      the expenditure of energy reserves of the body, allowing a critical look at overweight.

      The role of overweight in the development of atheromatous fat was revealed. The positive
      results from the weight loss in patients with atherosclerotic disease were drawn. Developed
      the metabolic concept of atherosclerosis associated with evolutionary aging and conversion of
      lipids in hard atherosclerotic fat.
    

Intervention name(s): Conventional treatment; Weight loss treatment
Intervention type(s): Drug; Dietary Supplement
Intervention description(s): Lipidlowering: "Atorvastatin" (Liprimar) - 40mg per day. Antihypertensive: "Diroton" (Lisinopril, Gedeon Richter Ltd) - 10mg twice per day and "Ditiazem" (calcium bloker from the benthodiazepines, Lannacher, Austria) - 90mg per day.
Antihyperglycemic drugs: biguanides "Metformin" - 0.5 g two or tree times per day, or "Exenatide" - 5-10 µg per day.
Anti-inflammatory: "TromboACC" (acetylsalicylate acid) up to 2 g per day and/or "Clopidogrel" (thienopyridine class antiplatelet agent) - 75mg per day.; Weight loss treatment by administering a healthy very low-calorie, low-fat vegetables and salt diet and includes an adjustment and modify eating behavior and increased physical activity.
Other intervention name(s): Pathogenetic and symptomatic treatment; vegetable and salt diet
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: atherosclerosis, development of concept, weight loss therapy
ED50 and ED95 of Intranasal Dexmedetomidine in Pediatric Patients Undergoing Transthoracic Echocardiography Study
Condition: Patients for Transthoracic Echocardiography; Unknown Diagnosis
Study type: Interventional
Phase: Phase 4

Summary: 
      The median effective dose (ED50) and ED95 of intranasal dexmedetomidine as a single bolus
      have not been described for sedation in children undergoing transthoracic echocardiography
      (TEE) study. This information is important to compare agents and to determine the most
      effective sedative dose. The investigators performed a two-stage study to determine the ED50
      and the ED95 of intranasal dexmedetomidine to investigate age-related differences in
      participants undergoing transthoracic echocardiography study.
    

Detailed description: 
      The investigators performed a two-stage study to determine the ED50 and the ED95 of
      intranasal dexmedetomidine in children undergoing transthoracic echocardiography study. In
      phase 1, 120 participants were randomized in a Dixon-Massey study to describe the minimum
      local sedative dose. In phase 2, a further 160 participants were randomly allocated to
      receive sedation with doses in the upper dose-response range to define the ED95
    

Intervention name(s): intranasal dexmedetomidine
Intervention type(s): Drug
Intervention description(s): Phase 1, Children received a bolus of intranasal dexmedetomidine which adjusted by the "Dixon up-and-down method for TEE study. The first child received 2.5 mcg/kg of intranasal dexmedetomidine dose (100mcg/ml), and the dose varied by 0.1 mcg/kg according to the up-and-down method Phase 2 was a dose-escalation study. After interim analysis of the phase 1 results, four dose levels above the calculated ED50 were defined. Dose spacing was set at 0.25 mcg/kg of intranasal dexmedetomidine consistent with the re-estimated standard deviation (SD).
Intervention MeSH terms: Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Dose-Response Relationship, Drug
Training in Exercise Activities and Motion for Growth
Condition: Single Ventricle Physiology
MeSH terms: Univentricular Heart
Study type: Interventional

Summary: 
      To determine if an exercise program of passive range of motion (ROM) is safe and feasible in
      infants with single ventricle (SV) physiology after their Norwood procedure.
    

Detailed description: 
      This is a non-randomized pilot study to evaluate the safety and feasibility of an exercise
      program in hospitalized infants with single ventricle physiology. Following the Norwood
      procedure, the intervention will be administered for up to 21 days or until discharge,
      whichever comes first. Data will be collected daily during hospitalization and at a follow-up
      visit at 3 months of age. Sources of data will include medical record review. Twenty subjects
      will be enrolled at three Pediatric Heart Network study sites (Utah Primary Children's
      Hospital, Children's Hospital of Philadelphia and Texas Children's Hospital). Subjects will
      be recruited following Institutional Review Board (IRB) approval at each institution and
      parental/legal guardian consent.
    

Intervention name(s): Passive range of motion (ROM) exercise
Intervention type(s): Other
Intervention description(s): After their Norwood surgery, stable subjects will undergo passive ROM exercise therapy for up to 21 consecutive days or until hospital discharge, whichever comes first. Subjects will have completed the study after their anthropometric measurements are collected at 3 months of age
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Passive range of motion; Single ventricle; Infants; Congenital heart disease
Social Exergaming for Healthy Weight in Adolescent Girls
Condition: Obesity and Physical Inactivity in Adolescents
Study type: Interventional

Summary: 
      The purpose is to evaluate the feasibility of a 12-week exergaming dance program for
      adolescent girls. This study combines dancing, video games, and a full body work-out to test
      if video games can increase physical activity and promote healthy weight in adolescent girls.
      We hypothesize that girls who play the dance exergames, versus those in the control group,
      will lose weight, decrease body fat and visceral fat, improve cardiovascular health, increase
      physical activity, and improve psychosocial health including self-confidence and quality of
      life.
    

Detailed description: 
      Klub Kinect will last about 14 weeks for each participant. The program begins with a 3.5 hour
      clinic visit, the intervention lasts for 12 weeks, and the participant comes in for a final
      3.5 hour clinic visit.
    

Intervention name(s): Klub Kinect
Intervention type(s): Behavioral
Intervention description(s): Dance Central and Just Dance are a series of rhythm games developed by Harmonix Music Systems exclusively for the Xbox 360 Kinect. The Dance Central suite of games (Dance Central 1, 2, and 3) and Just Dance will be played on the Xbox 360+ Kinect gaming console, which employs whole body movement using an infrared sensor that tracks body movements such that an external controller device is not required. The player performs dance moves demonstrated by on-screen characters and set to popular music, with a choice of over 650 dance moves, 90 dance routines, and over 300 songs.
The exergaming condition will wear a pedometer to record total steps during game play, and they will participate in private weigh-ins at each session to track body weight over the 12-week intervention.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Physical Activity; Sedentary Behavior; Video Games; Exergames
Chemotherapy Toxicity Reduction Via Urea Cycle Support
Condition: Cancer
Study type: Interventional
Phase: Phase 2

Summary: 
      Patients undergoing bone marrow transplantation (BMT) and peripheral blood stem cell
      transplants (PBSCT) frequently develop organ dysfunctions, much of which may be initiated by
      damage to the liver and to cells lining blood vessels.

      We, the researchers at Vanderbilt University, propose to perform a randomized, prospective,
      double-blind, placebo-controlled study of 144 patients undergoing allogeneic marrow
      transplantation. The treatment is aimed at supporting hepatic urea cycle function in patients
      receiving escalated dose chemotherapy/BMT. By so doing we hope to prevent development of
      hepatic venoocclusive disease (HVOD) and acute lung injury (ALI), two morbid complications of
      BMT. Patients will be randomized to receive oral citrulline, a urea cycle amino acid
      intermediate, or placebo beginning before conditioning therapy and continuing until 21 days
      after BMT. All patients will be followed for 100 days after study enrollment with intensive
      data collection.
    


Intervention name(s): Citrulline; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral provision of amino acid citrulline to support impaired urea cycle function during escalated dose chemotherapy for stem cell transplant
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Peripheral Blood Stem Cell Transplant; Bone Marrow Transplant; Citrulline; Urea Cycle; Hepatic Injury; Allogeneic PBSCT; Matched-Unrelated PBSCT
Mycophenolate Mofetil (MMF) Versus Intravenous CTX Pulses in the Treatment of Adult Severe HSPN
Condition: Henoch-Schoenlein Purpura; Nephritis
MeSH terms: Nephritis; IgA Vasculitis; Purpura
Study type: Interventional

Summary: 
      This study is performed to compare the efficacy, safety, tolerability and relapse of MMF vs
      CTX in the treatment of severe HSPN
    

Detailed description: 
      Henoch-Schoenlein purpura nephritis (HSPN) with massive proteinuria,renal insufficiency and
      crescent formation at onset have high risks of progressing to end stage renal failure. Though
      clinical studies have shown that steroids in combination with cyclophosphamide could reduce
      proteinuria and preserve renal function, this protocol is associated with many side effects,
      and is not effective in some patients.

      Recent studies have shown that mycophenolic acid(MPA), the active metabolite of mycophenolate
      mofetil(MMF),could inhibit multifarious effects on endothelial cells, including adhesion
      molecular expression, neutrophil attachment,IL-6 secretion, and the process of angiogenesis,
      which contribute to the efficacy of MMF in the treatment of vasculitis. Clinical studies also
      showed that MMF was effective in the treatment of lupus nephritis with vasculitic lesions.
      These findings suggest that MMF might be effective in the treatment of severe HSPN, which is
      a kind of vasculitic lesion. This prospective open-labeled clinical trial study investigates
      the efficiency of MMF in the treatment of severe HSPN compared with pulse intravenous
      cyclophosphamide. After 12 months of treatment, we will assess the efficacy, safety,
      tolerability and relapse of MMF compared with cyclophosphamide in the treatment of severe
      HSPN.
    

Intervention name(s): Mycophenolate mofetil
Intervention type(s): Drug
Intervention description(s): MMF,1.0g/d
Other intervention name(s): Mycophenolate mofetil,cellcept
Intervention MeSH terms: Mycophenolic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Henoch-Schonlein purpura nephritis Mycophenolate mofetil; Cyclophosphamide; treatment
Safety and Pharmacokinetic Profile of Udenafil in Healthy Mexican Adults
Condition: Erectile Dysfunction; Phosphodiesterase 5 Inhibitor
MeSH terms: Erectile Dysfunction
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and tolerability of Udenafil 150 mg
      compared to placebo.
    

Detailed description: 
      The drug being tested in this study is called Udenafil. Udenafil is being tested to determine
      a safe and well-tolerated dose. This study will look at vital signs, laboratory tests and
      side effects in people who take Udenafil.

      The study will enroll approximately 84 patients. Participants will be randomly assigned (by
      chance) and by blocks to assure balanced groups (i.e. same number of participants) to one of
      the four treatment schemes-which will remain undisclosed to the patient and study doctor
      during the study (unless there is an urgent medical need):

        -  a) Udenafil-Udenafil

        -  b) Udenafil- Placebo

        -  c) Placebo-Udenafil

        -  d) Placebo-Placebo

      All participants will be asked to take one tablet on Day 1 and one tablet on Day 3.

      This single-centre trial will be conducted in Mexico. The overall time to participate in this
      study is up to 7 days. Participants will make 3 visits to the clinic, including 5 days
      confinement to the clinic, and will be contacted by telephone 15 days after last visit to the
      clinic for a follow-up assessment.
    

Intervention name(s): Udenafil; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Udenafil tablets; Placebo tablets
Intervention MeSH terms: Udenafil
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: Drug therapy
Effect of Pregabalin Administration on Catheter- Related Bladder Discomfort in Urological Surgical Operations
Condition: Pregabalin on Catheter Related Bladder Discomfort
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The aim of this study is to assess the effect of pregabalin administration on
      catheter-related bladder discomfort (CRBD). The study group includes patients that are about
      to be subjected to urological operations because of the high incidence of CRBD observed in
      this kind of surgical population.
    


Intervention name(s): Placebo oral capsule; Pregabalin Oral Capsule [Lyrica] 75mg; Pregabalin Oral Capsule [Lyrica] 150 mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Placebo oral capsule administered 1 hour prior to the surgical operation; Pregabalin Oral Capsule [Lyrica] 75 mg administered 1 hour prior to the surgical operation; Pregabalin Oral Capsule [Lyrica] 150 mg administered 1 hour prior to the surgical operation
Other intervention name(s): Pregabalin; Pregabalin
Intervention MeSH terms: Pregabalin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective, double-blind,randomized, placebo controlled trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: urinary bladder; urinary catheters; pregabalin
Clinical Validation of Stool DNA-based SDC2 Methylation Test for Colorectal Cancer Detection
Condition: Colorectal Cancer; Polyps; Other Cancers; Healthy
MeSH terms: Colorectal Neoplasms
Study type: Observational

Summary: 
      Pivotal trials of SDC2 methylation biomarker test in stool DNA to estimate clinical
      sensitivity and specificity in detection of colorectal cancer.
    

Detailed description: 
      The purpose of this study is to validate the clinical performance of EarlyTect Colon Cancer
      test which is measuring Syndecan 2 methylation status in stool DNA to detect CRC. Syndecan 2
      (SDC2) is a newly developed methylation biomarker for colorectal cancer diagnosis.
      Methylation status of SDC2 gene in stool DNA is determined by methylation specific qPCR.
      Sensitivity and specificity will be determined by comparing Stool DNA test from healthy
      subjects, CRC patients, and other group including polyps and other diseases.
    

Intervention name(s): EarlyTect Colon Cancer
Intervention type(s): Device
Intervention description(s): SDC2 methylation assay by qPCR using EarlyTect Colon Cancer kit
Observational model: Case-Control
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        Patients who have colorectal cancer or pre-malignancy or benign polyp or other solid tumor,
        or healthy normal subjects, and confirmed by colonoscopy or pathological examination.
      
Keywords: Syndecan 2; Methylation biomarker; Colorectal cancer; EarlyTect Colon Cancer test