bioihbjkbjnl/mcl2 huggingface dataset:
Trial on TAP Block After Bariatric Surgery
Condition: Morbid Obesity
MeSH terms: Obesity, Morbid
Study type: Interventional

Summary: 
      Patients undergoing bariatric surgery will be divided randomly into two groups: the first
      will have TAP block upon completion of surgery and the second groups will not have TAP block.
    

Detailed description: 
      Upon completion of the laparoscopic bariatric procedure to be performed for every patient and
      just before recovery from general anesthesia, an ultrasound-guided TAP block will be
      conducted in the operative theater by the anesthetist for group I patients whereas group II
      will be recovered from anesthesia without having a TAP block.

      The ultrasound probe will be placed on the lateral abdominal wall in the mid-axillary line
      between the lower costal margin and iliac crest. Using ultrasound will allow accurate
      deposition of the local anesthetic in the correct neurovascular plane. A spinal needle will
      be advanced using in-plane technique between the aponeurosis of the internal oblique and
      transversus abdominis muscles. With intermittent aspiration, 20 mL of local anesthetic (0.25%
      bupivacaine) will be deposited in the TAP on each side and seen as a hypoechoic shadow
      pushing the two layers apart.
    

Intervention name(s): TAP block; Bariatric surgery
Intervention type(s): Procedure; Procedure
Intervention description(s): Injection of 20 mL of 0.25% bupivacaine in the transversus abdominis plane under ultrasound guidance after performing bariatric surgery; Bariatric surgery will be conducted
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Glucosamine Sulphate, Ginger, Ginger-Avocado-Soya and Ginger-Ibuprofen for Chronic Back Pain
Condition: Back Pain
MeSH terms: Back Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      The main purpose of this study is to investigate the ability of some dietary supplement
      products to affect general joint health and life quality in a selected population with back
      pain.

      The study is randomized and double - blind, with parallel groups receiving treatment for a
      duration of 12 weeks.
    


Intervention name(s): Glucosamine sulphate; Ginger; Ginger-Avocado-Soya; Ginger-ibuprofen
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Ibuprofen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: back pain
An ACDF Multi-Center Study Using ViviGen Cellular Bone Matrix
Condition: Cervical Spondylosis; Degenerative Intervertebral Discs; Herniated Disc
MeSH terms: Spondylosis; Intervertebral Disc Displacement; Intervertebral Disc Degeneration
Study type: Observational

Summary: 
      The purpose of this post-market study is to collect data on ViviGen and how its use affects
      fusion rates in the cervical spine when used as additional grafting material to fill the
      cervical spacer. The patient population of interest is patients who have already elected to
      undergo a 2-3 level ACDF surgical procedure using ViviGen, per standard of care.
    


Intervention name(s): ViviGen
Intervention type(s): Other
Intervention description(s): ViviGen Cellular Bone Matrix is a formulation of cryopreserved viable cortical cancellous bone matrix and demineralized bone. ViviGen is a Human Cells, Tissues, and Cellular and Tissue-based Product (HCT/P) as defined by the U.S. Food and Drug Administration in 21 CFR 127 1.3(d).
Other intervention name(s): ViviGen Cellular Bone Matrix
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Male or female patients with cervical spondylosis, degenerative disc disease (DDD), or
        herniated nucleus pulposus (HNP) who are to receive cervical spine surgery with anterior
        column support at two or three contiguous levels (C2-C7)
      
Keywords: ViviGen; ACDF; Cervical
Citrulline Supplementation Combined With Exercise: Effect on Muscle Function in Elderly People (CITEX Study)
Condition: Sarcopenia; Obesity
MeSH terms: Sarcopenia
Study type: Interventional

Summary: 
      The main objective of this study is to determine if oral supplementation of Citrulline, when
      combined with HIIT, can produce significant changes in body composition, muscle quality,
      muscle metabolism and functional capacity in older obese men and women .

      The investigators hypothesize that Citrulline combined with HIIT will be more beneficial than
      HIIT alone which will be more beneficial than citrulline alone which will be more beneficial
      than placebo alone in obese elderly men and women .
    

Detailed description: 
      Citrulline is a non-protein amino acid, isolated from watermelon, involved in the urea cycle
      and an arginine precursor. Participants will take 10g/d of citrulline or placebo
      (isocaloric).

      High intensity interval training (HIIT) is a high intensity aerobic training (30 sec at 85%
      and up of HRmax + 1min30 at 65-70% of HRmax). they HIIT duration is 30 min/session. HIIT is
      recognized as beneficial to improve health in human such as Vo2max, body fat or .

      Then intervention will be follow during 12 consecutive weeks.
    

Intervention name(s): Citrulline; Placebo; Exercise; without exercise
Intervention type(s): Dietary Supplement; Other; Behavioral; Other
Intervention description(s): Twelve weeks of citrulline oral supplementation will be taken by half of the participants (other are taken a placebo). Citrulline supplementation will be taken orally. Ten grams of citrulline (white powder) will be mixed with a liquid daily. Supplementation will be consumed once at lunch time.; Twelve weeks of oral placebo will be taken by half of the participants. Ten grams of placebo (maltodextrin white powder) will be mixed with a liquid and will be consumed once daily at lunch time.; Participants will also take part in twelve weeks of HIIT (30s at 85% and up of maximal heart rate + 1m30sec at 60-75% of maximal heart rate (HR max). 3 times/ week during 30 continuous minutes. Each period are supervised and monitored using borg scale and polar system.; No exercise program will be assigned to participants.
Other intervention name(s): High intensity interval training (HIIT)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Muscle function; Functional capacity
The Effect of Processed Tomato Products on CVD Risks
Condition: Cardiovascular Disease
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      The primary working hypothesis is that consuming processed tomatoes frequently/daily will
      favorably improve endothelium and platelet function disease-risk biomarker profiles in adult
      men and women compared to consuming no or relatively low amounts of processed tomatoes.
    


Intervention name(s): Tomato products
Intervention type(s): Dietary Supplement
Intervention description(s): Specified amounts of tomato products (i.e. tomato juice, ketchup, salsa, tomato soup, spaghetti sauce) to be consumed daily during a 6 week intervention phase.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cardiovascular disease; Lycopene; Tomato
A Study of the Safety and Efficacy of SP-624 in the Treatment of Adults With Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase 2 clinical study evaluating the safety and effectiveness of SP-624 as
      compared to placebo in the treatment of adults with Major Depressive Disorder.
    


Intervention name(s): SP-624; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral capsule; Oral capsule
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Left Radial comparEd to Femoral Approach for CORonary Angiography in Patients With Previous CABG StuDy
Condition: Coronary Artery Disease; Vascular Access Complication
MeSH terms: Coronary Artery Disease
Study type: Interventional

Summary: 
      This randomized, multicenter, prospective study seeks to compare left radial and femoral
      access during cardiac catheterization of patients with prior history of CABG surgery, with
      the primary objective of demonstrating that the two access techniques do not differ in the
      net procedure time (non-inferiority study) expanding the documented benefits of radial access
      to this group of patients.
    

Detailed description: 
      Patients from 4 different centers with a history of CABG are randomized 1:1 to left radial or
      femoral access. Based on the literature, a randomized study sample of a total of 150 patients
      was calculated with assumptions of 30 +/- 10-minute duration of the procedure, alpha = 5%,
      beta = 10% (power 90%) and non-inferiority limit Δ = 5 minutes. The primary endpoint of the
      study is the time it takes after placing the sheath at the initial puncture site until the
      completion of the diagnostic procedure (Net procedure time). Secondary endpoints include
      total time of the procedure, fluoroscopy time, total patient exposure radiation, amount of
      contrast used, possible vascular complications, major cardiovascular events and need for
      crossover access site.
    

Intervention name(s): Coronary Angiography
Intervention type(s): Procedure
Intervention description(s): Comparison of left radial versus femoral access during coronary angiography of patients who have undergone coronary artery bypass grafting surgery
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: L-RECORD; Radial; Femoral; CABG; coronary artery bypass graft
Impact of Subthalamic Nucleus Deep Brain Stimulation on Pain in Parkinson Disease
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      Pain is a common symptom of Parkinson's disease (PD) but the physiology remains poorly
      understood. Recent work suggests that subthalamic nucleus deep brain stimulation (STN-DBS)
      could make a profit on the pain in PD.

      The investigator would drive a study with a follow up of PD patients before and after
      STN-DBS. The pain will be clinically explored by targeted questionnaires and
      electrophysiological through laser evoked potentials.

      The questionnaires are designed to quantify and characterize the pain in these patients.
      Laser evoked potentials will, through repetitive stimulation, study both the functional
      status of the afferent nociceptive pathways, their habituation to repetitive nociceptive
      stimuli, and so better understand any abnormalities of the central processing of nociceptive
      information.
    


Intervention name(s): Laser-Evoked potential
Intervention type(s): Other
Intervention description(s): Laser-Evoked potential can document lesions of spinothalamic tract and lateral brainstem and of thalamo-cortical projections conducting nociceptive signals. The rapid heating of skin by infrared laser pulses stimulate small fibers sensory pathways. The main cortical laser evoked potential is a complex of components N2-P2. Evaluation of the registered potentials includes shape, latency and amplitude.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Parkinson Disease; Pain; Deep Brain Stimulation; Laser-Evoked Potentials
Oxidative Stress and Vitamin E Requirements
Condition: Smoking
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine if oxidative stress derived from cigarette smoking
      increases vitamin E requirements. The study will also assess the role of vitamin C in
      modulating vitamin E requirements. Vitamin E requirements will be assessed by measuring
      vitamin E in plasma as well as by measuring the excreted vitamin E metabolite in the urine.
    

Detailed description: 
      We will be investigating the fractional disappearance rate of tocopherols in cigarette
      smokers compared to nonsmokers. This will be accomplished by supplementing individuals with
      deuterium labeled alpha- and gamma-tocopherols. Quantification of plasma tocopherols as well
      as urinary metabolites, alpha- and gamma-carboxy ethyl hydroxychromanol, will be determined
      using liquid chromatography/mass spectrometry analysis. In addition, the role of vitamin C as
      it pertains to its influence on the fraction disappearance rate of vitamin E will also be
      evaluated.
    

Intervention name(s): Vitamin E with and without Vitamin C
Intervention type(s): Drug
Intervention MeSH terms: Vitamins; Vitamin E
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: cigarette smoking; tocopherol; bioavailability; metabolism; oxidative stress
Feasibility Study to Determine the Optimal Calibration Method for Glucose Sensors
Condition: Diabetes
Study type: Interventional

Summary: 
      Two new glucose sensors (IR-Glucose Reader (Joanneum Research, Austria), IR-CGM (IMM,
      Germany)) will be investigated to determine the optimal calibration method in patients with
      type 1 diabetes
    

Detailed description: 
      The subjects (Type 1 diabetes) will stay at the Clinical Research Centre for the whole period
      of the investigation (12 hours).

      Continuous blood glucose monitoring will be performed using the IR-Glucose Reader system
      and/or the IR-CGM system based on microdialysis. In parallel blood glucose measurements will
      be performed every 15 min as reference. The measurements of the sensors will be calibrated
      with different schemes and the difference between the calibrated glucose readings and the
      reference blood glucose values will be determined.
    

Intervention name(s): Insulin dosing; Glucose sensors IR-Glucose Reader (Joanneum Research, Austria), IR-CGM (IMM, Germany)
Intervention type(s): Drug; Device
Other intervention name(s): Subjects will use their daily usual insulin:; Lantus; Levemir; Humalog; Novorapid; Sensors:; IR-Glucose Reader (Joanneum Research, Austria); IR-CGM (IMM, Germany)
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Study to Compare LBVD to Eupenta and Imovax Polio in Healthy Adults
Condition: Diphtheria; Tetanus; Pertussis; Poliomyelitis; Hepatitis B; Haemophilus Influenzae Type b Infection
MeSH terms: Hepatitis B; Diphtheria; Poliomyelitis; Haemophilus Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single-center, randomized, active-controlled, parallel-group, open-label, phase I
      study to evaluate safety and immunogenicity of single injection of LBVD or Eupenta
      co-administered with Imovax Polio in healthy adults.
    


Intervention name(s): DTP-HepB-IPV-Hib vaccine; DTP-HepB-Hib vaccine & IPV
Intervention type(s): Biological; Biological
Intervention description(s): Hexavalent vaccine (DTP-HepB-IPV-Hib vaccine: Diphtheria-Tetanus-Pertussis-Hepatitis B-Inactivated Poliovirus-Haemophilus influenzae type b vaccine); Pentavalent vaccine (DTP-HepB-Hib vaccine: Diphtheria-Tetanus-Pertussis-Hepatitis B-Haemophilus influenzae type b vaccine)+ IPV(Inactivated poliovirus vaccine)
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
A Multiple Dose Escalation Study of ASKP1240 in Subjects With Moderate to Severe Plaque Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to explore the safety and tolerability of multiple doses of
      ASKP1240 compared to placebo and determine Pharmacokinetics and Pharmacodynamics in subjects
      with moderate to severe psoriasis.
    

Detailed description: 
      Treatment with ASKP1240 or placebo will be over 4 weeks (Baseline/Day 1, Days 15 and Day 29)
      with 12 weeks of follow-up for a total of 16 weeks.
    

Intervention name(s): ASKP1240; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Intravenous; Intravenous
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Moderate Psoriasis; Severe Psoriasis; Skin disease; ASKP1240; CD40 antigen; Anti-CD40 monoclonal antibody
A Randomized, Open-label, Two-way Crossover Trial to Determine the Pharmacokinetics of Metoclopramide When Administered as the Orally Disintegrating Tablet Compared to Reglan® Tablets in Subjects With Diabetic Gastroparesis
Condition: Diabetic Gastroparesis
MeSH terms: Gastroparesis
Study type: Interventional

Summary: 
      To determine whether a new Orally Disintegrating Tablet of Reglan (metoclopramide) is
      metabolized faster than the conventional Reglan tablet in patients with diabetic
      gastroparesis, pharmacokinetics following a single 10 mg dose of each formulation are being
      compared. Subjects must be 18 or older, have Type 1 or 2 diabetes with documented
      gastroparesis and agree to withhold medications for gastroparesis for 3 days prior to each
      dosing. Exclusion criteria include serum glucose >300 mg/dL, Hb1Ac >10%, and concurrent
      illness interfering with gastrointestinal motility. Subjects will stay in the clinic
      overnight, and pharmacokinetic sampling will continue for 8 hours after the first morning
      dose. The time (Tmax) and amount (Cmax) of peak concentration and the area under the curve
      (AUC) from time zero to 8 hr will be compared for the 2 formulations.
    

Detailed description: 
      See approved Package Insert for Adverse Event information.
    

Intervention name(s): Reglan ODT
Intervention type(s): Drug
Intervention MeSH terms: Metoclopramide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effect of Bariatric Surgery on Peripheral Nerve Function and Axonal Regeneration
Condition: Peripheral Neuropathy; Obesity
MeSH terms: Peripheral Nervous System Diseases
Study type: Observational

Summary: 
      The goal of this research is understand if obesity is a major factor for neuropathy
      development in patients with and without Type 2 diabetes. This study will examine the
      relationship between weight, metabolism, and nerve function and regeneration.
    

Detailed description: 
      Peripheral neuropathy causes progressive injury to the longest nerves of the body, starting
      in the toes, then progressing slowly up the leg. Neuropathy often causes pain, numbness, and
      weakness if the feet and can lead to reduced mobility, foot ulcers, and even amputation. The
      most common cause is diabetes, but work at the University of Utah finds that prediabetes and
      other consequences of obesity, including abnormal cholesterol levels, may be associated with
      neuropathy. Research has shown that these risk factors may damage nerves and interfere with
      the ability of nerves to grow back after an injury.

      This study aims to

        1. characterize peripheral nerve function and cutaneous nerve structure in obese bariatric
           surgery candidates;

        2. evaluate peripheral nerve regeneration capacity (and other nerve function measures)
           before and after bariatric surgery in obese subjects with no or mild neuropathy;

        3. examine the relationship between ectopic lipid accumulation, lipotoxic mediators,
           neuropathy and regeneration capacity in surgical candidates before and one year after
           surgery.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participants will be recruited through bariatric surgery clinics in the local area.
      
Biospecimen description: 
      DNA, serum, tissue
    
Keywords: Bariatric surgery; Obesity; Neuropathy
Pilot BA Study of New LY03005 vs Pristiq
Condition: Major Depression
MeSH terms: Depressive Disorder, Major
Study type: Interventional
Phase: Phase 1

Summary: 
      The objects of this study is to assess the relative bioavailability (BA) of 80 mg LY03005
      oral tablets compared to 50 mg Pristiq® oral tablets after a single oral intake under fasting
      conditions in healthy subjects between 18 and 50 years of age.
    

Detailed description: 
      Twenty (20) eligible subjects will be enrolled and assigned to either LY03005 group or
      Pristiq group at a 1:1 ratio at one site in the USA.
    

Intervention name(s): LY03005; Pristiq
Intervention type(s): Drug; Drug
Intervention description(s): LY03005
Other intervention name(s): Desvenlafaxine
Intervention MeSH terms: Desvenlafaxine Succinate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Long-term, Extended Treatment Study of Aripiprazole in Pediatric Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this study is to investigate the safety and efficacy of aripiprazole
      (initial dose 2 mg/day, maintenance dose 6-24 mg/day, maximum dose 30 mg/day) orally
      administered over a period of 52 weeks in subjects who complete a short-term treatment study
      of pediatric patients (aged 13-17 years) with schizophrenia (031-09-003 study).
    


Intervention name(s): Aripiprazole
Intervention type(s): Drug
Other intervention name(s): Abilify
Intervention MeSH terms: Aripiprazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Schizophrenia, Pediatric patients