bioihbjkbjnl/mcl2 huggingface dataset:
Activ-L™ Artificial Disc Treatment of Degenerative Disc Disease in the Treatment of Degenerative Disc Disease
Condition: Degenerative Disc Disease
MeSH terms: Spinal Diseases; Intervertebral Disc Degeneration
Study type: Interventional

Summary: 
      The purpose of this study is to learn whether an investigational device called the Activ-L
      Artificial Disc is safe and effective in the treatment of degenerative disc disease of the
      lower (lumbar) spine.
    

Detailed description: 
      The objective of this clinical study is to evaluate the safety and effectiveness of the
      Activ-L Artificial Disc for treatment of single-level degenerative disc disease of the lumbar
      spine in patients who have been unresponsive to at least six months of prior conservative
      care. The hypothesis of the study is that the Activ-L Disc is non-inferior to the control
      (the Charité® Artificial Disc [DePuy Spine] or ProDisc-L® Total Disc Replacement [Synthes
      Spine]) with respect to the rate of individual subject success at 24 months. Individual
      subject success is a composite of effectiveness and safety.
    

Intervention name(s): Activ-L Artificial Disc; ProDisc-L Total Disc Replacement or Charité Artificial Disc
Intervention type(s): Device; Device
Intervention description(s): Implantation at one level of the lumbar spine, either L4/L5 or L5/S1.; Implantation at one level of the lumbar spine, either L4/L5 or L5/S1.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Degenerative; Disc
Oculomotor Training Improves Reading Eye Movement
Condition: Ocular Motility Disorders
MeSH terms: Ocular Motility Disorders
Study type: Interventional

Summary: 
      Children with reading eye movement problems were recruited for this study. The treatment
      group was provided with oculomotor training for 8 weeks, the control group was given placebo
      exercises.
    

Detailed description: 
      Purpose of study Reading is one of the integral elements for learning and poor readers were
      reported to have less efficient reading eye movements. They were typically characterized by
      having higher number in fixation and regression, reduced reading speed and perceptual span.
      The purpose of this study was to investigate if vision therapy which limited to training of
      oculomotor skills can improve reading eye movement.

      Methodology This was a randomized, prospective study. 30 subjects aged from 8-9 years of age
      with reading difficulties and reading eye movement problems were recruited. They all have
      normal intelligence and ocular health, but failed to meet the Taylor reading eye movement
      norms when tested with the Visagraph III. The subjects were randomly assigned into either the
      treatment group (15) or the control group (15). The treatment group had to go through a
      course of oculomotor vision therapy and the control group was given placebo exercises. Vision
      therapy for the treatment group involved 8 weeks of training (office training - 3 times a
      week, 30 min per session; home training - 4 times a week, 30 min per session). Office
      training involved the use of Vis-Flex (Visual Flexibility Trainer - an electronic device with
      L.E.D. lights which can display various flashing patterns at variable speeds). Home training
      involved several saccadic eye movement exercises. Subjects and parents were also asked to
      grade the reading symptoms checklist before and after the training.
    

Intervention name(s): oculomotor training; placebo
Intervention type(s): Other; Other
Intervention description(s): a sequence of vision training exercises which focused mainly in oculomotor skill; placebo vision training exercises involving minimal accommodation and vergence eye movement.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: reading eye movement
A Single and Multiple Dose Study of Canagliflozin in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine blood and urine concentrations of canagliflozin and
      glucose in healthy adult volunteers after administration of single and multiple doses of
      canagliflozin.
    

Detailed description: 
      This is an open-label (volunteers and study staff will know the name and dose of the
      treatment assigned), single-center study of canagliflozin (JNJ-28431754) in healthy adult
      volunteers. Canagliflozin (a sodium-glucose cotransporter 2-inhibitor) is currently under
      development to lower blood sugar levels in patients with Type 2 diabetes mellitus (T2DM).
      Healthy volunteers will take canagliflozin 50 mg, 100 mg, or 300 mg tablets, orally (by
      mouth), once daily on Day 1 and on Days 4 to 9. All study drug administration will occur at
      approximately the same time each morning with 240 mL of noncarbonated water and will be
      followed by a standardized breakfast within 10 minutes.
    

Intervention name(s): Canagliflozin 100 mg; Canagliflozin 50 mg; Canagliflozin 300 mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Tablets, oral, 100-mg, once daily on Day 1 and on Days 4 through 9.; Tablets, oral, 50-mg, once daily on Day 1 and on Days 4 through 9.; Tablets, oral, 300-mg, once daily on Day 1 and on Days 4 through 9.
Intervention MeSH terms: Canagliflozin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pharmacokinetics; Pharmacodynamics; Canagliflozin
A Study to Evaluate Rebif® New Formulation (Interferon-beta-1a) in Relapsing Remitting Multiple Sclerosis
Condition: Multiple Sclerosis, Relapsing-Remitting
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional
Phase: Phase 3

Summary: 
      General Note: throughout this record, "Rebif® New Formulation" is used for historical and
      consistency purposes.

      Objectives:

      Primary: To evaluate the efficacy of Rebif® New Formulation (Interferon-beta-1a
      [IFN-beta-1a], RNF), compared to placebo, in subjects with Relapsing Remitting Multiple
      Sclerosis and active disease by means of Magnetic Resonance Imaging (MRI) at the end of 16
      weeks of treatment Secondary: To evaluate the efficacy of RNF by comparing the mean number of
      combined unique (CU) lesions per scan per subject between the initial 16 weeks of placebo
      treatment and 24 weeks of RNF treatment in the same subjects, originally randomized to
      placebo.

      Primary Endpoints: The primary endpoint is the difference between the number of CU active MRI
      lesions at Week 16 in the RNF group (Group 1) versus the placebo group (Group 2).

      Secondary Endpoints: The secondary endpoint is the difference in the mean number of CU active
      MRI lesions per scan per subject over the following treatment periods: Study Day 1 - Week 16
      versus Weeks 17 - 40 for the subjects randomized to Group 2.
    


Intervention name(s): Rebif® New Formulation (IFN-beta-1a, RNF); Placebo; Rebif® New Formulation (IFN-beta-1a, RNF)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): RNF will be administered at a dose of 44 mcg subcutaneously three times a week for 40 weeks.; Matching placebo will be administered subcutaneously three times a week for 16 weeks.; RNF will be administered at a dose of 44 mcg subcutaneously three times a week from Week 17 to Week 40.
Other intervention name(s): IFN-beta-1a; IFN-beta-1a
Intervention MeSH terms: Interferon beta-1a; Interferon-beta
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Subjects with relapsing remitting multiple sclerosis
Insulin Glulisine and Aspart in Postprandial Glycemic Control After High-GI Meal in Children With Type 1 Diabetes Mellitus
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study is to determine whether insulin glulisine is more effective in
      postprandial glycemic control than insulin aspart after the H-GI meal in children with type 1
      diabetes (T1DM) treated with insulin pump (CSII).
    

Detailed description: 
      Some studies have suggested that insulin glulisine (GLU) has a slightly faster onset of
      action compared with insulin aspart (ASP). Meals of high glycemic index (H-GI) have distinct
      effect on postprandial glycaemia (PPG).
    

Intervention name(s): Insulin glulisine; Insulin aspart
Intervention type(s): Drug; Drug
Other intervention name(s): Apidra®; NovoRapid®
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin glulisine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: diabetes; insulin pump; glulisine; aspart; glycemic index
Relative Bioavailability of Single Dose Empagliflozin (BI 10773) When Co-administered With Multiple Doses of 600 mg Gemfibrozil Compared to Single Dose Treatment With Empagliflozin (BI 10773) When Given Alone in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate the relative bioavailability of BI 10773 following coadministration with 600
      mg gemfibrozil bid dosed to steady-state in comparison to BI 10773 when given alone.
    


Intervention name(s): BI 10773; Gemfibrozil; BI 10773
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 1 tablet single dose BI 10773 in the morning; Gemfibrozil 600 mg bid for 5 days; 1 tablet single dose BI 10773 in the morning
Intervention MeSH terms: Empagliflozin; Gemfibrozil
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Albinterferon Alfa 2b Single Dose in Japanese Chronic Hepatitis C Patients
Condition: Chronic Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of
      albinterferon alfa 2b (alb-IFN) single dose in Japanese chronic hepatitis C patients
    


Intervention name(s): Albinterferon alfa 2b
Intervention type(s): Biological
Intervention description(s): recombinant human albumin-interferon alfa fusion protein, 600-1800mcg single dose by S.C. on Day 0
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chronic hepatitis C, Albinterferon alfa 2b, phase I, Japan
Identification of Gluten Sensitivity in Irritable Bowel Syndrome
Condition: Non-celiac Gluten Sensitivity; Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Hypersensitivity; Syndrome
Study type: Interventional

Summary: 
      The aim of our study will be to establish in how many subjects with gastrointestinal symptoms
      and previous diagnosis of irritable bowel syndrome (IBS), the clinical picture is
      attributable to non celiac gluten sensitivity (NCGS) or fermentable oligosaccharides,
      disaccharides, monosaccharides and polyols (FODMAPs) intolerance. For this purpose, all
      subjects with IBS will take a low FODMAPs diet, which implies the absence of cereals and
      consequently of gluten, and those presenting symptom improvement during this dietary
      treatment, will be exposed to a double-blind gluten or placebo challenge, to make a diagnosis
      of NCGS.
    

Detailed description: 
      Study design:

      For this study, patients with diagnosis of IBS performed by Rome IV criteria and followed as
      outpatients at the Clinical Nutrition Clinic of "Petrucciani" Nursing Home of Lecce (LE),
      Italy, will be enrolled.

      At baseline, the enrolled subjects will follow a balanced normal-caloric low-FODMAP and
      gluten-free diet for a period of 4 weeks. At the end of the 4 weeks patients who did not
      experience an improvement in symptoms will be considered "non-responders" and discontinue the
      clinical trial. Only those subjects who had showed a significant improvement in symptoms,
      will be enrolled for the phase 2 of the study that includes a challenge with gluten or with
      placebo, as described by the Salerno criteria.
    

Intervention name(s): diet containing gluten; Diet containing placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): gluten will be added for 7 days to the low FODMAP/gluten free diet diet. After 1 week of wash-out, patients will switch (cross-over) to placebo for another 7 days; Placebo will be added for 7 days to the low FODMAP/gluten free diet diet. After 1 week of wash-out, patients will switch (cross-over) to gluten for another 7 days
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Interventional study
Masking: Double (Participant, Investigator)
Primary purpose: Diagnostic
Keywords: gluten free diet; FODMAPs; gastrointestinal symptoms
Treatments for Improving Mood in Depressed Teens-2
Condition: Depression
MeSH terms: Depression
Study type: Interventional

Summary: 
      Phase 2: Open Trial N=12 adolescents will be enrolled into a single-arm pilot trial to test
      the adapted hatha yoga intervention
    

Detailed description: 
      In Phase 2, the investigators will conduct an open single-arm pilot trial of our 12 week
      adapted hatha yoga intervention.

      the investigators will enroll 12 adolescents in the open pilot trial.
    

Intervention name(s): Hatha Yoga
Intervention type(s): Behavioral
Intervention description(s): 12 weeks of Hatha Yoga
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Efficacy Study of BRIMOCHOL™, BRIMOCHOL™ F, and Carbachol in Subjects With Emmetropic Phakic and Pseudophakic Presbyopia
Condition: Presbyopia
MeSH terms: Presbyopia
Study type: Interventional
Phase: Phase 2

Summary: 
      Safety and Efficacy Study of BRIMOCHOL™ vs. BRIMOCHOL™ F vs. Carbachol Monotherapy Topical
      Ophthalmic Solutions in Subjects with Emmetropic Phakic and Pseudophakic Presbyopia
    

Detailed description: 
      A 3-Dose, Multicenter, Randomized, Double-Masked, Crossover Phase 2 Safety and Efficacy Study
      of BRIMOCHOL™ Topical Ophthalmic Solution vs. BRIMOCHOL™ F Topical Ophthalmic Solution vs.
      Monotherapy with Carbachol Topical Ophthalmic Solution in Subjects with Emmetropic Phakic and
      Pseudophakic Presbyopia
    

Intervention name(s): BRIMOCHOL™; BRIMOCHOL™ F; Carbachol
Intervention type(s): Drug; Drug; Drug
Intervention description(s): A single drop in each eye at a visit.; A single drop in each eye at a visit.; A single drop in each eye at a visit.
Other intervention name(s): carbachol/brimonidine tartrate; carbachol/brimonidine tartrate; carbachol monotherapy
Intervention MeSH terms: Brimonidine Tartrate; Carbachol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Safety and Efficacy of Tafamidis in Patients With Transthyretin Cardiomyopathy
Condition: Transthyretin (TTR) Amyloid Cardiomyopathy
MeSH terms: Cardiomyopathies
Study type: Interventional
Phase: Phase 3

Summary: 
      This Phase 3 study will investigate the efficacy, safety and tolerability of an oral daily
      dose of 20 mg or 80 mg tafamidis meglumine capsules compared to placebo in subjects with
      either transthyretin genetic variants or wild-type transthyretin resulting in amyloid
      cardiomyopathy.
    

Detailed description: 
      Phase 3, multicenter, global, three-arm, parallel design, placebo-controlled, double-blind,
      randomized study to determine efficacy, safety and tolerability of tafamidis on clinical
      outcomes (all-cause mortality and frequency of cardiovascular-related hospitalizations) in
      subjects with either transthyretin genetic variants or wild-type transthyretin resulting in
      amyloid cardiomyopathy.
    

Intervention name(s): Tafamidis; Tafamidis; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Tafamidis 20 mg in soft gel capsules administered once a day for 30 months; Tafamidis 80 mg in soft gel capsules administered once a day for 30 months; Placebo in soft gel capsules administered once a day for 30 months
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: amyloidosis; amyloid; transthyretin; TTR
Perception of Baby's Painful Cry in fMRI
Condition: Magnetic Resonance Imaging; Neuronal Activity
Study type: Interventional

Summary: 
      Crying is the primary signaling strategy available to the human newborn for eliciting
      parental care. Yet, the investigators only have superficial understanding of the information
      carried by cries, and how this information is perceived by parents. Using modern tools of
      sound processing and functional Magnetic Resonance Imaging (fMRI) experiment, this study aims
      to investigate cry-induced brain activation in adult depending on the cry's acoustic
      properties expressing various degrees of stress and distress levels. For that, Adults will be
      tested inside a fMRI magnet to determine their brain activations elicited by different babies
      cries according to whether the cry was evoked in a pain situation or not. The cerebral
      activity will be investigated in relation to acoustic features of cries (e.g. with pitch
      and/or roughness variations). To test if the gender or parentally of adult listeners
      influence their perceptions and brain responses, the task will be applied to 2 different
      groups (men and women not-parents). The hypothesis is that the brain of adult listeners will
      be able to discriminate adequately the intensity of the pain mediated by the cries. This
      process should involve brain areas such as the insular and the orbito frontal cortex that are
      known to participate in the integration of pain intensity and pain controls. The experiment
      should also determine which one of the acoustic features is able to transmit pain and to
      recruit brain areas involved in pain processes.
    


Intervention name(s): functional Magnetic Resonance Imaging (fMRI)
Intervention type(s): Other
Intervention description(s): During fMRI, healthy volunteers will listen 80 baby's cry.
Other intervention name(s): fMRI
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: 20 men and 20 women : group "non parent" 20 father and 20 mother : group "parent"
Masking: None (Open Label)
Primary purpose: Other
Keywords: Baby cries; pain; brain responses; neuroimaging; fMRI
Evaluation of Relative Bioavailability of D-0502 Tablet in Healthy Female Subjects
Condition: Healthy Female Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      Relative Bioavailability study of D-0502 tablet formulation in healthy female subjects
    

Detailed description: 
      Phase 1, Open Label, Randomized, Single dose, 3 Period, 3 treatment study to evaluation the
      relative Bioavailability of D-0502 tablet formulation in healthy female subjects
    

Intervention name(s): D-0502
Intervention type(s): Drug
Intervention description(s): Formulation 1 Formulation 2 Formulation 3
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Influenza Vaccine in Pregnancy Part 2
Condition: Influenza; Pregnancy
MeSH terms: Influenza, Human
Study type: Observational

Summary: 
      Pregnant women have limited knowledge regarding influenza, its implications during pregnancy,
      and recommendations for vaccination during pregnancy. The researchers plan to distribute an
      information pamphlet to women in a prenatal clinic, offer the vaccine during prenatal visits,
      and then give a questionnaire on the postpartum floor assessing knowledge.

      The researchers hypothesize that with education intervention, knowledge scores on the
      questionnaire will be higher than those from last year, when no education was provided.
    


Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        A multi-ethnic group of pregnant women
      
Keywords: influenza; vaccine; pregnancy
The Feasibility Study of Dual-Section Nasogastric Tube
Condition: Stroke; Mouth Neoplasms
MeSH terms: Mouth Neoplasms
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The purpose of this studyis to assess the feasibility and safety of novel designed two-piece
      nasogastric tube.
    


Intervention name(s): two-piece nasogastric tube
Intervention type(s): Device
Intervention description(s): one week period
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Phase I Trial of Weekly MEDI-522 in Patients With Refractory Solid Tumors
Condition: Cancer
Study type: Interventional
Phase: Phase 1

Summary: 
      To determine the safety profile of single and multiple doses of MEDI522 in patients with
      refractory solid tumors.
    


Intervention name(s): MEDI-522
Intervention type(s): Drug
Intervention description(s): MEDI-522 will be administered at doses of 1.0, 2.0, 4.0, 6.0, 8.0, and 10.0 mg/kg. [As a 30 minute IV infusion initially as a single dose (single-dose treatment period) and 2 to 5 weeks later as weekly doses (multiple-dose treatment period) for up to 1 year.]
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Ultrasound Guided Modified Pectoral Plane Block Versus Erector Spinae Plane Block During GA in Gynecomastia Surgery
Condition: Gynecomastia, Adolescent
MeSH terms: Gynecomastia
Study type: Interventional

Summary: 
      Pain of breast surgery is due to chest wall scar and arm in some cases like carcinoma or due
      to nerve injury.It is neuropathic or nociceptive pain.Its severity is depending on the extent
      of surgery and the radiotherapy if needed.

      Previous studies proved that local nerve block procedures improved the immediate
      postoperative pain and decreased the incidence of postoperative pain chronicity .

      Also effective control of pain suppresses the surgical stress response minimizes the
      anaesthestic needs intraoperatively and decreases the opioid needs postoperatively .

      Pectoralis nerve(pecs) II block and erector spinae plane (ESP) block are novel procedures
      that may provide good intraoperative and postoperative analgesia in patients undergoing
      surgical treatment of gynecomastia.
    


Intervention name(s): PECS II versus ESP
Intervention type(s): Procedure
Intervention description(s): compare between :ultrasound guided Pectoralis nerve(pecs) II block or erector spinae plane (ESP) block in surgical treatment for gynecomastia patients under general anaesthesia.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Supportive Care