bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Fasting Mimetic Diet on Nephropatic Patients
Condition: Renal Insufficiency, Chronic
MeSH terms: Renal Insufficiency; Renal Insufficiency, Chronic
Study type: Interventional

Summary: 
      Fasting mimetic diet (FMD) showed positive effects on cardiovascular risks. Purpose of the
      trial is to evaluate FMD effects on patients affected by chronic kidney disease (CKD),
      through the stimulation of kidney stem cells and improving cardiovascular and metabolic
      status.

      From April 2018, the investigators enrolled 13 patients (7 male) with an history of primary
      glomerulonephritis (GMN) and an eGFR between 60 ml/min and 30 ml/min. Exclusion criteria are:
      age <18 y.o., age> 65 y.o., secondary GMN, severe heart failure (NYHA IV),ongoing infectious
      diseases, ongoing neoplasia, hepatic diseases, COPD, inflammatory bowel disease, history of
      stroke, history of acute coronary disease less than 3 months, pregnancy, refuse informed
      consent.
    


Intervention name(s): Fasting mimetic diet
Intervention type(s): Dietary Supplement
Intervention description(s): Fasting mimetic diet for 5 days, another cycle after 25 days
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Chronic kidney disease; Fasting mimetic diet; Kidney stem cells
Nebivolol in the Supine Hypertension of Autonomic Failure
Condition: Hypertension; Pure Autonomic Failure; Multiple System Atrophy
MeSH terms: Multiple System Atrophy; Shy-Drager Syndrome; Pure Autonomic Failure; Hypertension
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the effect of the antihypertensive drug, nebivolol
      (Bystolic), compared to metoprolol (Lopressor) and sildenafil (Viagra) on blood pressure in
      patients with autonomic failure and supine hypertension.
    

Detailed description: 
      Nebivolol is distinct among beta-blockers by its ability to increase nitric oxide (NO)
      bioactivity. The contribution of this effect to the pharmacological actions of the drug,
      however, is difficult to ascertain in normal subjects because of the confounding contribution
      of the autonomic nervous system. Autonomic failure patients provide a unique model of
      hypertension devoid of autonomic modulation but sensitive to NO mechanisms. We propose to
      determine the effect of nebivolol on blood pressure in this patient population. A decrease in
      blood pressure will imply increased bioactivity of NO. Comparisons will be made with placebo,
      metoprolol (as a negative control) and sildenafil (as a positive control).
    

Intervention name(s): Placebo; Nebivolol 5 mg; metoprolol tartrate 50 mg; Sildenafil25 mg
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Placebo capsule; Nebivolol 5mg single oral dose; metoprolol tartrate 50 mg single oral dose; Sildenafil 25 mg single oral dose
Other intervention name(s): sugar pill; Bystolic; Lopressor; Viagra
Intervention MeSH terms: Metoprolol; Nebivolol; Sildenafil Citrate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Keywords: supine Hypertension; autonomic failure; nitric oxide; nebivolol
Intrathecal Bupivacaine Versus Bupivacaine and Clonidine in Paediatrics Age Group:A Comparative Evaluation
Condition: Pediatric Spinal Anesthesia
Study type: Observational

Summary: 
      The investigators can summarize intrathecal clonidine can potentiate bupivacaine thereby
      bringing about better quality and longer duration of analgesia, better sedation and better
      postoperative outcomes with minimal side effects.
    

Detailed description: 
      In our Randomized controlled, double blind study involving 30 subjects in two groups; the
      investigators compared the safety, efficacy and quality of using intrathecal hyperbaric
      bupivacaine 0.5% and hyperbaric bupivacaine 0.5% with clonidine 1µg/kg in paediatric patients
      undergoing surgeries below T8 dermatome.

      American Society of Anesthesiologists (ASA) Grade I patients aged between 3-10 years were
      scheduled for the surgeries below T8 dermatome up to two hrs duration. The patients were
      randomly allocated in - Group A-who received 0.5%of hyperbaric Bupivacaine 0.4mg/kg for 5
      to15 kg or 0.3 mg/kg for more than 15 kg intrathecally.

      Group B-who received 0.5%of hyperbaric Bupivacaine 0.4mg/kg for 5 to15 kg or 0.3 mg/kg for
      more than 15 kg and 1µg/kg preservative free clonidine intrathecally.

      The patients studied across the group did not vary much with respect to age, weight and sex
      distribution.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        prospective,randomized,double blind study cariied in 60 ASA grade 1 pediatric patients
        undergoing surgeries below T8 dermatome upto two hours duration.
      
Keywords: bupivacaine; clonidine; pediatric spinal; efficacy; duration; quality; side effects; intrathecal bupivacaine alone; bupivacaine plus clonidine
A New Adaptive Feeding Plan for Newborns
Condition: Infant Nutrition
Study type: Interventional

Summary: 
      The purpose of this clinical trial is to identify the infant formula(s) for which the
      investigators get the closest gut maturation index compared to the one they get with
      breastfed babies.
    


Intervention name(s): BSF; BSF + Lactoferrin + Probiotics; BSF + Lactoferrin + Probiotics + OS
Intervention type(s): Other; Other; Other
Intervention description(s): feeding amount according to individual baby need; feeding amount according to individual baby need; feeding amount according to individual baby need
Intervention MeSH terms: Lactoferrin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: Infant Formula; Gut
Pharmacodynamic Study of the Effect of INCB013739 on Insulin Sensitivity in Obese, Type 2 Diabetic Subjects
Condition: Diabetes Mellitus, Type 2; Obesity
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      Purpose: A 28-day US study in patients with type 2 diabetes mellitus to assess the safety and
      tolerability as well as the effects of treatment with an investigational drug.
    


Intervention name(s): Placebo; INCB013739
Intervention type(s): Drug; Drug
Intervention description(s): Matching placebo of 100 mg BID; INCB013739 100 mg BID
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Diabetes;; Type II diabetes;; Non-insulin dependent diabetes;; Obesity
Evaluate the Safety and Efficacy of Canakinumab in Pediatric Patients With Colchicine Intolerant or Colchicine Resistant Familial Mediterranean Fever (FMF)
Condition: Colchicine Resistant/Intolerant Familial Mediterranean Fever
MeSH terms: Brucellosis; Familial Mediterranean Fever; Hereditary Autoinflammatory Diseases; Fever
Study type: Interventional
Phase: Phase 2

Summary: 
      A study designed to evaluate the role of treatment with a biological agent - Canakinumab in
      pediatric (age 4-20) Familial Mediterranean Fever (FMF) patients that are intolerant or
      resistant for colchicine treatment.

      The study hypothesis is that Canakinumab will reduce attack frequency and severity.
    


Intervention name(s): Canakinumab
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: FMF, Colchicine resistant; Colchicine intolerant; Flare rate; Canakinumab
Ischemia-reperfusion Injury Model on Healthy Volunteers and Measurement of Oxidative and Inflammatory Markers
Condition: Ischemia-reperfusion Injury
MeSH terms: Reperfusion Injury; Ischemia; Wounds and Injuries
Study type: Observational

Summary: 
      Oxygen is necessary for the survival of oxygen consuming organisms. But the organisms
      metabolism alter the oxygen to free radicals. Free radicals are molecules which due to their
      structure can react with other molecules resulting in cell damage. This damage is due to
      several mechanisms.

      This is e.g what happens when human tissue is cut of from blood supply for a time, and the
      blood supply is again restored. The damage following the restoration of blood is known as
      "ischemia-reperfusion injury". The reopening of the vessels and thereby supplying oxygenated
      blood to the deprived tissue can in it self contribute to cell death due to excessive amounts
      of free radicals. Antioxidants can neutralize free radicals and thereby minimize their
      damage.

      The purpose of the investigators methodology study is to make an ischemia-reperfusion model
      on healthy volunteers (on the lower limb) to examine the expression of markers that are
      expressed in the muscle and the blood when blood supply is cut of to an area and later
      restored. The investigators wish to measure the product of the damage caused by free radicals
      and the levels of antioxidants.

      If the investigators can produce elevation of oxidative and inflammatory markers, this model
      can be used to test antioxidative intervention.
    


Sampling method: Probability Sample
Study population: 
        Healthy volunteers. Male aged 18-40 years. Non smokers. No known history of familiar
        cardio/vascular diseases. No intake of prescription medicine.
      
Keywords: Ischemia-reperfusion injury; Oxidative markers; Inflammatory markers
Vibration Anesthesia for Propofol- Rocuronium Injection Pain
Condition: Vibration; Pain Due to Certain Specified Procedures
Study type: Interventional

Summary: 
      Despite numerous strategies for preventing or alleviating pain associated with propofol and
      rocuronium injections, it remains common and distressing for patients. Vibration is an
      effective method of reducing pain during facial cosmetic injections and some venipuncture
      procedures. But it has not been previously studied in the context of propofol or rocuronium
      injection pain. This randomized study aims to evaluate the effect of vibration anesthesia on
      the incidence and severity of propofol and rocuronium injection pain.
    

Detailed description: 
      Due to their rapid onset and short duration of action, ease of titration, recovery, and
      favorable profile for side effects, propofol and rocuronium are agents frequently used
      together in anesthesia practice and for rapid-sequence intubation. However, both cause severe
      discomfort due to pain in the injection arm. Some patients recall the induction of anesthesia
      as the most painful part of the perioperative period.

      Vibration anesthesia has repeatedly been shown to alleviate pain sensation effectively and
      safely. Vibration anesthesia device is designed to reduce the pain from minor procedures,
      such as injection of medications, suture or staple removal, phlebotomy and even venipuncture
      pain in pediatric patients. The advantages of this device include its low cost, lack of
      adverse effects, and ease of use.

      It has been shown to reduce pain with a mechanism based on the gate control theory, which
      states that vibrations stimulate the dorsal horn neurons, the sites at which pain signals are
      modulated and thus block full transmission of the pain.The investigators therefore proposed
      this randomized controlled study to compare the effectiveness of a vibration device for
      propofol and rocuronium injection pain during general anesthesia induction.
    

Intervention name(s): vibration device , Beauty bar facial massaging device, T-Shape Electric Sign Face Massage Tools, Dangshan, China
Intervention type(s): Device
Intervention description(s): The vibration device is a reusable, handheld device with a battery-powered motor and a vibration frequency of approximately 6000 times per minute (Beauty bar facial massaging device, T-Shape Electric Sign Face Massage Tools, Dangshan, China)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: vibration; analgesia; propofol injection pain; rocuronium injection pain
Ultrasound to Predict the Prognosis of Rotator Cuff Tears
Condition: Rotator Cuff Tear
MeSH terms: Rotator Cuff Injuries
Study type: Observational

Summary: 
      To predict the prognosis of large-to-massive RCTs and risk of re-tear by ultrasound
      elastography.
    

Detailed description: 
      Most symptomatic large-to-massiverotator cuff tears (RCTs) should be operated, but the
      prognosis and postoperative risk of re-tear depended on the quality of rotator cuff muscles.
      Preoperative evaluations were usually done by magnetic resonance imaging (MRI). MRI was used
      in recent studies to predict the surgical outcome of large-to-massive RCTs and postoperative
      re-tear, but the clinical availability was not as good as ultrasound. The investigators
      hypothesize that ultrasound elastography can predict the prognosis of large-to-massive RCTs
      and risk of re-tear.
    

Intervention name(s): Sonoelastography
Intervention type(s): Other
Intervention description(s): This diagnostic test would be executed by a physician who has experiences of using Siemens Acuson S2000 ultrasound system for more than three year. The examination includes two of four rotator cuff muscles, listed as follows, supraspinatus muscle and infraspinatus muscle. Linear transducer (4-9 MHz) would be used for the whole test. The probe would be positioned along the longitudinal axis of the muscle belly. Compressive sonoelastography technique is used for semiquantitative analysis. In order to maintain the quality of images, quality factor needs to be over or equal to 60. The quantitative analysis was performed by shear wave sonoelastography and the region of interest (ROI) would be divided into four quadrants. The physicians will measure the shear wave velocity at the center point of each quadrant.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The investigator will enroll participants with diagnosis of large-to-massive rotator cuff
        tears who will receive surgical repairs later, and sonoelastography and MRI are necessary
        for preoperative evaluation.
      
Keywords: Rotator cuff tears; surgery; ultrasound; elastography
Study of DTRI-031 in Healthy Volunteers
Condition: Healthy Volunteers; Pharmacokinetics; Pharmacodynamics
Study type: Interventional
Phase: Phase 1

Summary: 
      A randomized, double-blind, single center, placebo-controlled phase 1 study in healthy
      volunteers to assess safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of
      a single intravenous (iv) injection of DTRI-031
    

Detailed description: 
      Up to 5 cohorts of 8 healthy volunteers for a total of 40 volunteers will be randomized to
      either DTRI-031 or matching placebo (6 active:2 placebo). Two sentinel subjects, one
      randomized to each group, will be dosed at least 1 day prior to dosing of the remaining
      subjects in a cohort.

      Subjects will complete a screening visit up to 28 days prior to administration of study drug
      to confirm eligibility. Eligible subjects will arrive at the phase 1 unit up to 24 hours
      prior to Day 1 and remain until completion of 24-hour assessments. Subjects will return for a
      Day 7 follow-up visit and receive a safety assessment telephone call on Day 28.

      A Safety Review Committee will review individual subject and aggregate group safety data
      following each dose-based study cohort and recommend whether the trial should continue to the
      next cohort.
    

Intervention name(s): DTRI-031; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Investigational drug; Matching placebo to DTRI-031
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, placebo-controlled, double-blinded, dose escalation to evaluate the safety, PK, and PD of a single dose of investigational drug or placebo
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Safety and Efficacy Study of Copaxone Administered in Combination With N-Acetylcysteine
Condition: Relapse Remitting Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      This study evaluates the effect of the therapy combining GA and NAC on disease activity as
      reflected by MRI parameters while assessing tolerability and safety.
    


Intervention name(s): Glatiramer Acetate, N-Acetylcysteine
Intervention type(s): Drug
Intervention description(s): Subcutaneous glatiramer acetate 20 mg and concomitant oral administration of N-Acetylcysteine divided into two 2.5 g doses.
Intervention MeSH terms: Acetylcysteine; Glatiramer Acetate; N-monoacetylcystine; (T,G)-A-L
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of a 10 Component Dietary Supplement on Health and the Quality of Life
Condition: Blood Pressure; HDL Low; Stress; Lung Function Decreased; Quality of Life; Energy Supply; Deficiency; Concentration Ability Impaired; Joint Instability; Immune Deficiency
MeSH terms: Joint Instability; Immunologic Deficiency Syndromes
Study type: Interventional

Summary: 
      This open-label field trial evaluates the effects of treatment with a multi-pathway dietary
      supplement (Stem Cell 100+) that has been commercially available for several years. The
      objective of the intervention trial is to determine if normal subjects over 35 years of age
      experience any observable health benefits from the dietary supplement as to their blood
      pressure, pulse rate, blood cholesterol, lung capacity, stress levels, or self reported
      changes in markers of overall health and life expectancy.
    

Detailed description: 
      Currently, only dietary restriction has been verified to slow the rate of aging and to
      promote general health. This trial is designed to see whether a complex supplement (Stem Cell
      100+) that targets multiple longevity pathways could also have positive effects on several
      markers of successful aging and good health. Multipath causes of aging include: stem cell
      function, telomere loss, chronic stress, inflammation, insulin-like growth factors,
      autophagy, vascular loss, neural dysfunction, and oxidative stress. The goal of the study was
      to test the effects of this novel multipath intervention strategy in a clinical trial of
      healthy people using health markers such as blood pressure, cholesterol status, lung
      function, stress levels, and self-reported health status. Hundreds of published animal and
      human clinical studies have been done with each of the individual active ingredients in the
      formulation, which target many critical causes of aging.

      Based on their published animal studies showing extension of life span in a model animal and
      their laboratory work on adult human stem cells, the investigators believe that Stem Cell
      100+ will provide evidence of efficacy in addressing multiple index markers of health and
      life expectancy outcomes.
    

Intervention name(s): Stem Cell 100+
Intervention type(s): Dietary Supplement
Intervention description(s): Open-Label 10-Component Dietary Supplement
Other intervention name(s): SC100+
Intervention model: Single Group Assignment
Intervention model description: Open-label field trial without a placebo.
Masking: None (Open Label)
Primary purpose: Prevention
A Study to Evaluate a Modified Contact Lens
Condition: Myopia
MeSH terms: Myopia
Study type: Interventional

Summary: 
      This study is being conducted to evaluate the product performance of SofLens daily disposable
      contact lenses packaged in an investigational Test solution versus SofLens daily disposable
      contact lenses packaged in the currently marketed solution (Control), as it relates to
      comfort when worn by adapted soft contact lens wearers on a daily-wear basis.
    


Intervention name(s): SofLens in investigational solution; SofLens in currently marketed solution
Intervention type(s): Device; Device
Intervention description(s): SofLens in investigational solution, worn on a daily disposable basis for 7 days.; SofLens packaged in currently marketed solution, worn on a daily disposable basis for 7 days.
Intervention MeSH terms: Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: ocular irritation
Investigating the Impact of Self-monitoring Feedback for Health Behaviors
Condition: Obesity
Study type: Interventional

Summary: 
      Investigating the impact of self-monitoring feedback for health behaviors
    

Detailed description: 
      Obesity is highly prevalent in Samoa, where a 2010 study estimated that 64.6% of adult
      females were obese, according to Polynesian BMI cut offs (BMI ≥32.0 kg/m2).1,2 Interventions
      designed to increase physical activity or facilitate weight loss often include a
      self-monitoring component, but these intervention programs have not yet been tested in the
      Samoan setting. The goal of this project is to pilot test such an approach.

      The specific aims of this study are:

        1. To investigate the acceptability and feasibility of self-monitoring of physical activity
           and weight through the introduction of step counting devices (FitBit Zips) and scales
           (BodyTrace).

        2. To measure any changes that occur in participants' health, health behaviors related to
           diet and physical activity, or conceptions of health (including self-efficacy and
           perceptions of weight) over the study period.
    

Intervention name(s): step counter; weight scale; step counter with screen covered
Intervention type(s): Device; Device; Device
Intervention description(s): Fitbit; BodyTrace weight scale; Fitbit with screen covered
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Participant)
Primary purpose: Treatment