bioihbjkbjnl/mcl2 huggingface dataset:
Health Effects of Oat and Oat Polar Lipids in Human
Condition: Postprandial Glucose Regulation
Study type: Interventional

Summary: 
      Aim of the study is to investigate health effects of oats and oat derived components, in
      human intervention studies, with the purpose to build new knowledge for development of
      cardiometabolic protective foods.
    

Detailed description: 
      The overall goal is to increase the knowledge which can be used for the development of food
      products with anti-diabetic properties, with the purpose to facilitate healthier food choices
      for people. More specifically the primary purpose of this project is to evaluate effects in
      healthy humans on cardiometabolic test markers of oat and oat based product. The new
      knowledge will form a base for the development of oat based food products with added health
      values.
    

Intervention name(s): Effects of Oat and Oat Components on Cardiometabolic risk variables
Intervention type(s): Combination Product
Intervention description(s): Oat and oat bioactive components consumed as breakfast meal.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Prevention
A Phase 3 Study of Fluvoxamine (SME3110) in Pediatric/Adolescent Patients With Obsessive Compulsive Disorder
Condition: Obsessive Compulsive Disorder
MeSH terms: Compulsive Personality Disorder; Obsessive-Compulsive Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of the first phase of this study is to evaluate the efficacy of fluvoxamine
      compared to placebo on change in total score of Japanese version of the Children's Yale-Brown
      Obsessive Compulsive Scale (JCY-BOCS) 10-item from baseline to the last observation visit (10
      weeks) in pediatric/adolescent participants with obsessive compulsive disorder (OCD).

      The objective of the second phase of the study is to evaluate the long-term safety and
      efficacy of fluvoxamine in pediatric/adolescent patients with OCD.
    

Detailed description: 
      The first phase will be conducted in a randomized, placebo-controlled, double-blind manner to
      evaluate the efficacy of fluvoxamine on change from baseline to the last observation visit in
      the JCY-BOCS 10-item total score. Eligible patients will be allocated to the fluvoxamine
      group or placebo group in a 1:1 ratio using the experience of fluvoxamine treatment and age
      as stratification factors (dynamic allocation). The first phase consists of a screening
      period of 1-2 weeks, a forced titration dose period of 2 weeks, a dose adjustment period of 4
      weeks, a maintained dose period of 4 weeks, and a tapering dose period of 0-4 weeks.

      The 2nd phase will be conducted in an open-label manner in participants who completed the
      first phase to evaluate the long-term safety of fluvoxamine. The 2nd phase consists of 3
      periods; a forced titration dose period of 2 weeks, a flexible dose period of 50 weeks, and a
      tapering dose period of 0-4 weeks. After the last dose of study drug (including tapering dose
      period) or the early termination visit, participants will be followed for up to 30 days.
    

Intervention name(s): Fluvoxamine maleate; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Film-coated tablet containing 25 mg of fluvoxamine maleate; Placebo tablet matching to fluvoxamine maleate
Other intervention name(s): SME3110; Luvox; Depromel
Intervention MeSH terms: Fluvoxamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Obsessive Compulsive Disorder; Adolescent Subjects; Pediatric Subjects
Metabolic and Cardiovascular Impact of CD36 Deficiency in African Americans
Condition: Obesity
Study type: Observational

Summary: 
      CD36, a protein that facilitates tissue uptake of fat, as a common link between blood fat
      concentrations and metabolic disease states such as diabetes mellitus. Genetic variants in
      the CD36 gene are more common in African Americans compared to Whites and it may confer
      protection against metabolic diseases by altering the amount of fat in the blood.

      The purpose of this study is to compare the levels of fat in the blood and to assess
      endothelial dysfunction among carriers versus non-carriers of the coding SNP, rs3211938 of
      the CD36 gene after a high fat meal challenge
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        we will recruit subjects locally
      
Biospecimen description: 
      serum, white cells
Early Feasibility Study 2 of Outpatient Control-to-Range - Testing System Efficacy (France)
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      An unblinded, randomized, cross-over design with each patient participating in two 40-hour
      outpatient admissions: (a) Experimental involving automated Control-to-Range (CTR) and (b)
      Control using Continuous Glucose Monitor (CGM)-augmented insulin pump treatment outside of a
      hospital based clinical research center.
    

Detailed description: 
      The principal goal is to validate a smart phone-based control-to-range (CTR) system for
      ambulatory use and to estimate the effect of CTR vs. sensor-augmented pump therapy, thereby
      providing justification for further larger home-based trials of CTR.
    

Intervention name(s): Diabetes Assistant (DiAs)
Intervention type(s): Device
Intervention description(s): A medical platform that uses a smart-phone to connect to a continuous glucose sensor to insulin pump and run closed-loop control. The cell phone runs the Control to Range and is connected to work with the insulin pump and continuous glucose monitor to help keep the blood sugar in a desired range (80-180 mg/dL during the day) and help avoid hypoglycemia during the night.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetes Mellitus, Type 1 (T1DM); Continuous Glucose Monitor (CGM); Artificial Pancreas (AP); Insulin Pump; Closed Loop Control (CLC); Open Loop treatment; Diabetes Assistant; DiAs
Nutrition and Neurological Development of Very Preterm Infants
Condition: Premature Infant; Infant Nutrition Disorders; Delayed Mental Development
MeSH terms: Nutrition Disorders; Infant Nutrition Disorders
Study type: Observational

Summary: 
      The main goal of this study is to determine, in preterm infants born with a GA < 32 weeks,
      the association between:

        -  the quantity of mother's milk and duration and breastfeeding

        -  the intake of polyunsaturated fatty acids and iron during hospitalizations
    

Detailed description: 
      The main hypothesis of this study is that the intake of lipid during hospitalization in
      neonatology department is associated with neurological development of preterm infants born
      with a GA < 32 weeks. The other hypotheses are that iron intake and the duration of
      breastfeeding are also associated with the development of preterm infants.

      In the previous study EPINUTRI (NCT01486173), the development of infants was evaluated until
      the age of 1 year. EPINUTRI_3 is the follow-up of EPINUTRI until the age of 3 years.

      The aim of EPINUTRI_3 study is to determine the association between lipid intake during
      hospitalization in neonatology department of preterm infants born with a GA < 32 weeks.

      The secondary objective is :

      - to evaluate the association between these factors and communication, developmental and
      social-emotional delays with the test " Ages and Stages questionnaire " (ASQ) at 3 years of
      age.
    

Intervention name(s): Premature infants with a GA < 32 weeks
Intervention type(s): Other
Intervention description(s): At 3 years of age: ASQ (filled in by parents)
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subsample of infants born very preterm (before 32 weeks of gestation), otherwise included
        in the French national cohort EPIPAGE 2, and previously included in EPINUTRI study.
      
Biospecimen description: 
      saliva, whole blood
    
Keywords: Premature infants; Nutritional status; Polyunsaturated fatty acids status
Fecal Microbiota Transplant for Recurrent Clostridium Difficile Infection
Condition: Clostridium Difficile Infection
MeSH terms: Infections; Communicable Diseases; Clostridium Infections
Study type: Observational

Summary: 
      The purpose of this research is to investigate the efficacy of transplanting screened donor
      fecal material in treating patients with recurrent Clostridium difficile infection.
      Participants with refractory Clostridium difficile infection will be given healthy donor
      stool administered by colonoscopy or enema and their response will be evaluated by symptom
      questionnaire and stool testing for Clostridium difficile at 4 weeks after the treatment.
    


Intervention name(s): Fecal Microbial Transplantation
Intervention type(s): Biological
Intervention description(s): Participants with refractory Clostridium difficile infection will be given healthy donor stool administered by colonoscopy or enema.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who are referred for recurrent Clostridium difficile infections. Donors will be
        identified by the Recipient.
      
Biospecimen description: 
      A donor stool sample will be kept for future testing in case of contamination.
Tumor Necrosis Factors (TNF)-α Blockade for Psoriatic Arthritis
Condition: Psoriatic Arthritis
MeSH terms: Arthritis; Arthritis, Psoriatic
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is:

        -  To elucidate the immunomodulating properties of anti-TNF-α therapy in patients with
           psoriatic arthritis (PsA).

        -  To ascertain whether magnetic resonance imaging (MRI) is a sensitive tool in measuring
           early response after therapy with anti-TNF-α in the PsA wrist using the Outcome Measures
           in Rheumatoid Arthritis Clinical Trials (OMERACT) guidelines for rheumatoid arthritis
           (RA).

        -  To assess whether the lipid and other cardiovascular risk profiles would improve after
           anti-TNF-α therapy in patients with PsA.
    

Detailed description: 
      The study was a 12-week, open-label trial of anti-TNF therapy in 20 consecutive patients
      (Group 1). Another 20 consecutive patients with active disease whom have met the exclusion
      criteria, or were unwilling to start anti-TNF therapy for fear of toxicity would be recruited
      as control patients (Group 2). 20 healthy controls were recruited for comparison of the
      metabolic risk factors (Group 3). Study visits for groups 1 and 2 were conducted at baseline,
      weeks 2 and 6, and then week 12.
    

Intervention name(s): Infliximab; Etanercept
Intervention type(s): Drug; Drug
Intervention description(s): Infliximab 5 mg/kg given at day 1, week 2, week 6; Etanercept 25 mg twice weekly
Other intervention name(s): remicade; enbrel
Intervention MeSH terms: Infliximab; Etanercept
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Psoriatic Arthritis; TNF-α; Cardiovascular risk; Immunomodulatory activities
A Study of a New Local Anesthesia Method for Transperineal Prostate Biopsy
Condition: Prostate Biopsy; Local Anesthesia
Study type: Interventional

Summary: 
      In comparison with transrectal prostate biopsy, transperineal prostate biopsy has the
      advantage of better sampling from the anterior area, low risk of infection, and no rectal
      bleeding. The main problems associated with the transperineal method are pain control and
      additional general or spinal anesthesia. Three types of anesthesia have been reported for
      transperineal prostate biopsy: (1) spinal anesthesia; (2) general anesthesia; and (3) local
      anesthesia. From the viewpoint of patient selection (general anesthesia is contraindicated in
      some patients) and medical cost, local anesthesia is the most suitable choice for prostate
      biopsy. Periprostatic block is the standard method of local anesthesia for this procedure.
      However, periprostatic block is insufficient for transperineal prostate biopsy due to high
      pain sensitivity in this region. A number of new methods to eliminate pain have been
      reported, including (1) periapical triangle (PAT) block, (2) paraprostatic plus sexual nerve
      block, and (3) periprostatic block plus pudendal block.However, there is no anatomical basis
      for some of these methods, and there have been no randomized controlled trials to evaluate
      their effectiveness, and some methods are technically difficult to learn. In the previous
      perineal nerve autopsy, we found that there are two branches leading into the prostate and
      anterior lateral prostatic tissue, which is the main site of puncture pain. There is a fixed
      position where the two branches appear. Therefore, this anatomical position block may be a
      useful site for local anesthesia. We named this location the 'transperineal prostate biopsy
      local anesthesia switch' (abbreviated as TPA switch). In order to validate its effect, we
      organized this clinical trail.
    

Detailed description: 
      Ninety patients scheduled for prostate biopsy will include in this study. The clinical trial
      validation process will be as follows: (1) all patients are randomly divided into three
      groups (Figure 1): group 1, subcutaneous local anesthesia+periprostatic block; group 2,
      subcutaneous local anesthesia+periapical triangle (PAT) block; group 3, subcutaneous local
      anesthesia+TPA switch (transperineal prostate biopsy local anesthesia switch) block; VAS
      scores for each puncture and complications will be recorded.
    

Intervention name(s): local anesthesia of trnasperineal prostate biopsy
Intervention type(s): Procedure
Intervention description(s): three different block site with lidocaine
Other intervention name(s): lidocaine, long injection needles
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: transperineal prostate biopsy; local anesthesia; prostate cancer diagnosis
Safety and Efficacy of Dexmedetomidine (DEX) for Sedation of Subjects ≥1 Month to <17 Years Undergoing MRI Scans
Condition: MRI Sedation
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a randomized, double-blind, dose-ranging study of the efficacy and safety of
      dexmedetomidine (DEX) when used with propofol as needed, for procedural sedation of pediatric
      subjects ≥1 month to <17 years of age undergoing MRI scans in the US and Japan.
    


Intervention name(s): dexmedetomidine; propofol
Intervention type(s): Drug; Drug
Intervention description(s): dexmedetomidine low, middle and high doses are provided as an intravenous bolus loading dose followed by an intravenous maintenance dose infusion throughout the MRI scan; propofol IV administration will be given if needed to maintain sedation
Intervention MeSH terms: Dexmedetomidine; Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: procedural sedation; dexmedetomidine; propofol; MRI
Efficacy and Safety Study of SyB L-0501 in Combination With Rituximab in Patients With Untreated, Low-grade B Cell Non-Hodgkin's Lymphoma and Mantle Cell Lymphoma
Condition: Low-grade B Cell Non-Hodgkin's Lymphoma; Mantle Cell Lymphoma Where Hematopoietic Stem Cell Transplantation is Not Indicated
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin; Lymphoma, Mantle-Cell; Lymphoma, B-Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the efficacy and safety of SyB L-0501 (two-day
      consecutive 90 mg/m2/day IV drip infusions) in combination with rituximab (375 mg/m2 IV drip
      infusion) on untreated, low-grade B cell non-Hodgkin's lymphoma and mantle cell lymphoma
      where hematopoietic stem cell transplantation is not indicated.
    


Intervention name(s): SyB L-0501; rituximab
Intervention type(s): Drug; Drug
Intervention description(s): A dose of 90 mg/m^2/day of SyB L-0501 is administered on Day 1 and Day 2 as an IV drip infusion, followed by 26-day observation. This is 1 cycle (28 days), which will be repeated for a maximum of 6 times.; A dose of 375 mg/m^2 of rituximab is administered on Day 1 (Day 0 in Cycle 1 only) as an IV drip infusion, followed by 26-day observation. This is 1 cycle (28 days), which will be repeated for a maximum of 6 times. From Cycle 2, rituximab will be coadministered with SyB L-0501 on Day 1. However, if the investigator or sub-investigator judges that the coadministration is difficult, rituximab may be administered on Day 0.
Intervention MeSH terms: Rituximab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Thermotape High-adhesion Medical Tape Comparison Study
Condition: Skin Injury
MeSH terms: Tissue Adhesions
Study type: Interventional

Summary: 
      This objective of this study is to compare the safety and performance of Thermotape compared
      to Tegaderm™ tape and Kind™ tape over the course of 24 hours.
    


Intervention name(s): Thermotape; Tegaderm; Kind
Intervention type(s): Device; Device; Device
Intervention description(s): Thermotape will be applied along the left and right forearm. One piece of tape, one inch wide by two inches long, will be applied to each arm. The location the tape, when applied, will be randomized. Altogether, two pieces of this particular tape will be applied, one to each forearm.; Tegaderm™will be applied along the left and right forearm. One piece of tape, one inch wide by two inches long, will be applied to each arm. The location the tape, when applied, will be randomized. Altogether, two pieces of this particular tape will be applied, one to each forearm.; Thermotape will be applied along the left and right forearm. One piece of tape, one inch wide by two inches long, will be applied to each arm. The location the tape, when applied, will be randomized. Altogether, two pieces of this particular tape will be applied, one to each forearm.
Allocation: Randomized
Intervention model: Factorial Assignment
Intervention model description: Tegaderm™ tape, Kind™ tape, and Thermotape will be applied to both forearms for 24 hours. Afterwards, one forearm will have the tapes removed normally, without any intervention. The other forearm will have the tapes removed after heat is applied, using a heatpack.
Masking: Single (Participant)
Primary purpose: Other
Comparison of 2L NRL994 With NaP Preparation in Colon Cleansing Prior to Colonoscopies for Colon Tumor Screening
Condition: Colonoscopy
MeSH terms: Colonic Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      To compare the efficacy, acceptability and safety of the new 2 liter gut cleansing solution
      (Moviprep) and NaP preparation in routine colon cleansing prior to tumor screening
      colonoscopies
    

Detailed description: 
      This was a randomized and multicenter phase III study in ambulatory subjects undergoing an
      elective colonoscopy for colon cancer screening. Gut cleansing was performed using either the
      2 liters of Moviprep gut lavage solution or the 90 ml NaP-containing preparation prior to
      colonoscopy. Efficacy, acceptability and safety assessments was performed.
    

Intervention name(s): Macrogol 3350 Na sulphate NaCl KCl Ascorbic Acid Na Ascorbate; Sodium Phosphate solution (NaP)
Intervention type(s): Drug; Drug
Intervention description(s): 2L gut lavage solution; 45 ml solution; BID
Other intervention name(s): MOVIPREP®
Intervention MeSH terms: Ascorbic Acid; Polyethylene glycol 3350
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Colon cleansing; Polyethylene Glycol; Sodium Phosphate
Lidocaine 5% Plasters (Versatis® 5%) in Pediatric Neuropathic Pains and Vasoocclusive Sickle Cell Crisis Pains
Condition: Neuropathic Pains; Vasoocclusive Sickle Cell Crises Pains
MeSH terms: Neuralgia
Study type: Interventional
Phase: Phase 2

Summary: 
      Lidocaine 5% plaster (VERSATIS® 5%) showed its efficacy and safety in the post-herpetic
      zoster adult pains. This treatment is recommended in first intention in adult neuropathic
      pains with allodynia.

      The purpose of this study is to assess efficacy and safety of lidocaine 5% plaster (VERSATIS®
      5%) in the pediatric neuropathic pains and vasoocclusive sickle cell crises pains.
    

Detailed description: 
      Pediatric neuropathic pain are infrequent. It's difficult to estimate the prevalence. It may
      result from several causes : infectious (post-herpetic neuropathy), traumatic (tumor or
      Positional)or toxic (chemotherapy or radiotherapy). They are often associated with malignant
      pediatric disease.

      These pains are spontaneous, continuous or intermittent, as type of burns or electric shocks
      or abnormal skin sensation (hyperesthesia or allodynia). Treatment is the same as in adults:
      antiepileptic or neuroleptics, sometimes associated with analgesic (level 2 or 3).

      Lidocaine 5% plaster are used in adults as first line of treatment to reduce post-herpetic
      neuropathic pain, especially in cases of mechanical allodynia. These plasters are indicated
      for the symptomatic treatment of post-herpetic neuropathic pain.

      Each plaster contains 700 mg of lidocaine. It must be applied on the painful area once daily
      for a maximum period of 12 hours per 24 hours.

      The primary endpoint is to evaluate the efficacy of lidocaine 5% plaster (VERSATIS 5%) after
      12 hours on reducing of pure or mixed neuropathic pain and on reducing of vasoocclusive
      sickle cell pain, localized, superficial, in child, adolescent and young adult.

      The secondary endpoint are:

        1. to evaluate the efficacy of lidocaine 5% plaster (VERSATIS 5%) after 6 hours on reducing
           of pure or mixed neuropathic pain and on reducing of vasoocclusive sickle cell pain,
           localized, superficial, in child, adolescent and young adult.

        2. to evaluate safety of lidocaine 5% plaster (VERSATIS® 5%) in these same indications.
    

Intervention name(s): Lidocaine
Intervention type(s): Drug
Intervention description(s): Lidocaine 5% plaster
Other intervention name(s): Versatis® 5%
Intervention MeSH terms: Lidocaine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Child, adolescent, young adult; Plaster; Lidocaine