bioihbjkbjnl/mcl2 huggingface dataset:
Impulse Control in Gilles de la Tourette Syndrome
Condition: Tourette Syndrome
MeSH terms: Tourette Syndrome; Syndrome
Study type: Observational

Summary: 
      The study intends to evaluate the role of Mirror Neurons in the determination of gestures,
      words, and repetitive vocalizations in subjects affected by Tourette's syndrome and to verify
      if these subjects are faster to assemble sounds, in phonology and morphology, than the
      non-pathological population.
    


Intervention name(s): Routine tests perform
Intervention type(s): Other
Intervention description(s): The subjects of the Tourette group and control group are subjected to routine tests performed at Tourette Center and Extrapyramidal Diseases. Both groups are initially subjected to an evaluation that aims to identify the IQ and therefore 4 tasks are presented. The 1st (with a duration of about 2 and a half minutes) and the 2nd (with a duration of about 2 minutes) related to the motor field, the 3rd (with duration of about 1 minute) and the 4th (with duration about 3 minutes) the language field. These evaluations are in practice at the Center for Tourette patients; the tasks will be administered to both groups.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The calculated sample size is 20 subjects per arm considering:

          1. error of I type with two queues = 0.05;

          2. Type II error β = 0.20, which corresponds to a test power (1-β = 0.80) of 80%;

          3. a clinically significant difference of 4%;
Phase 1, Single and Multiple Doses Study of Sitaxentan in Japanese and Western Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate safety, tolerability and pharmacokinetics of
      sitaxentan following single and multiple oral administrations of sitaxentan sodium in
      Japanese healthy subjects.
    


Intervention name(s): Sitaxentan sodium/Placebo; Sitaxentan sodium/Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 100 mg and 200 mg, tablet, single and multiple oral doses for 7 days; 100 mg and 200 mg, tablet, single oral dose
Other intervention name(s): Thelin; Thelin
Intervention MeSH terms: Sitaxsentan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Arthroscopic Autologous Chondrocyte Implantation Versus Microfractures
Condition: Tear; Knee, Cartilage, Articular
MeSH terms: Fractures, Stress
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a phase III, randomised controlled trial of matrix-encapsulated chondrocyte
      implantation procedure compared to the microfracture procedure in the repair of symptomatic
      cartilage lesions of the knee. Eligible patients were asked for informed consent
      preoperatively and randomised for chondrocyte implantation of microfractures. Those patients
      allocated to the chondrocyte implantation group will be harvested at time of first
      arthroscopic procedure and concurrent lesions were treated, as meniscus repair, ligament
      reconstruction, or malalignment corrected. The patients allocated to microfracture will be
      treated at the time of the only arthroscopic procedure. Both groups will have the same
      rehabilitation program. Prospective clinical, radiographic and magnetic resonance imaging
      will be performed as main outcomes.
    


Intervention name(s): Matrix encapsulated chondrocyte implantation; Microfracture awl
Intervention type(s): Procedure; Procedure
Intervention description(s): Each implant contains 6,000,000 autologous chondrocytes.; Is an awl that allow perforation of the subchondral bone.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cartilage; Articular
Immediate Effects of Myofascial Release on the Quadriceps or Hamstrings on Active Cervical Range of Motion
Condition: Healthy
Study type: Interventional

Summary: 
      The purpose of this study is to verify the immediate effects of quadriceps or hamstring
      myofascial release on the active cervical flexion and extension range of motion.
    

Detailed description: 
      After completing the questionnaire, 60 healthy college students will be randomly divided into
      three groups named Intervention Group 1 (IG 1) (n=20), Intervention Group 2 (IG 2) (n=20) and
      Control Group (CG) (n=20). In the first assessment (M0), the cervical flexion and extension
      range of motion will be measured with a goniometer. The myofascial release technique (foam
      roller) will be applied on the hamstrings (IG 1) or quadriceps (IG 2) of the dominant lower
      limb for 4 minutes (3 series of 1 minute with 30s rest). Participants in the control group
      will remain at rest sitting in a chair for 4 minutes.

      Immediately after the intervention/control, both groups will be assessed, again (M1).
    

Intervention name(s): Dynamic foam rolling
Intervention type(s): Other
Intervention description(s): The foam roller will be in contact with the muscle being tested and the patient will exert a load until they feel a slight pain. In this way, the patient performs a self-massage in the direction of the muscle fibers.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Health Services Research
Side Population in Pancreatic Ductal Adenocarcinoma (PDAC)
Condition: Neoplasm; Pancreas
Study type: Observational

Summary: 
      In the current project we aim to study the oncological process of pancreatic cancer, from a
      perspective of the CSC-theory and in particular through the 'side population' (SP)-approach.
      The SP seems to be enriched for CSC and doesn't a priori exclude any CSC-subpopulation. After
      isolation from pancreatic cancer resection specimens, SP cells will be characterized by
      gene-expression profiling based on microarray analysis. We'll identify markers and pathways
      (with emphasis for stem cell and cancer -related ones) that are differentially expressed in
      SP versus the rest of tumour cells (the 'main population' or MP). In order to assess the
      prognostic relevance of the SP, we'll study these genes using the high-throughput Nanostring
      technology in about 200 snap-frozen PDAC resection specimens of patients from our prospective
      database. Finally, two monoclonal antibodies (mAB) will be tested as novel therapeutic agents
      in vivo (mouse model), wherein the choice of mAB will be based on prognostically relevant
      molecular targets and pathways obtained from the Nanostring results.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        SP cells will be identified through incubation with vital dye Hoechst 33342 of cell
        suspensions that are obtained from fresh human pancreatic cancer resection specimens.
      
Biospecimen description: 
      Pancreatic cancer tissue specimen
    
Keywords: pancreas; cancer; stem cell
Comparison of Effectiveness of Home Based Sensory Interventions Along With Standard Therapy Versus Standard Therapy Alone in Autistic Children With Sensory Processing Abnormalities
Condition: Autistic Children With Sensory Processing Abnormalities
MeSH terms: Congenital Abnormalities; Autistic Disorder
Study type: Interventional

Summary: 
      Around 69-95% of children with Autistic Spectrum Disorder are known to have sensory
      processing abnormalities .Tackling these problems would help in better quality of life, both
      for the parents and the children. Sensory integration therapy, an individualized clinic based
      therapy have been shown to have a positive effect on those children with sensory
      abnormalities. Hence the investigators are doing this study , to primarily look into the
      efficacy and feasibility of home based sensory interventions in autistic children with
      sensory processing abnormalities.
    


Intervention name(s): Sensory interventions
Intervention type(s): Other
Intervention description(s): Tactile stimulation: Brushing technique , handling materials of various textures, bear hug and rug , play dough and find in rice techniques to be done.
Proprioception technique : Joint compression , popping bubbles, lifting weights of different measures and scooter board push activities to be done.
Movement/vestibular techniques :Bear hug and rug , swinging or rocking motion, jumping or spinning to be done.
Visual stimulation : picture recognition, dot colouring , lighting balls and toys , familiarisation of emotions to be done.
Auditory stimulation : Sound familiarisation and music time will be done.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Autistic spectrum disorder; Sensory processing abnormalities; Sensory interventions; occupational therapy
A Study to Evaluate the Effectiveness and Safety of RXI-109 on the Outcome of Keloid Excision Surgery in Healthy Adults
Condition: Keloid
MeSH terms: Keloid
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate the effectiveness of RXI-109 in reducing the recurrence of keloid formation
      following elective keloid excision.
    


Intervention name(s): RXI-109; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Keloid; Cicatrix; Keloid prevention; Keloid revision/excision; Keloidectomy
Relationship Between Succinate Dehydrogenase Mutations and High-Altitude Illness
Condition: Altitude Intolerance; High-Altitude Illness
MeSH terms: Altitude Sickness
Study type: Observational

Summary: 
      This study is is the first step of a full study named CHEMOGENE because it explores the
      genetic determinant of an alteration of the chemoreflex. This reflex determines
      hyperventilation when the pressure of oxygen falls in the blood. This happens when subjects
      travel to high-altitude where oxygen levels diminish in the atmosphere. Subjects with such an
      altered chemoreflex are intolerant to altitude and develop pulmonary or cerebral edema
      associated with a severe headache. In this study we compare subjects tolerant to high
      altitude (8000 meters)to subjects intolerant to altitude. The chemoreflex is measured i.e.
      the hyperventilation associated with hypoxia and all subjects are scanned for the genes
      implicated in the mitochondrial respiratory chain. The idea is that subjects with an impaired
      oxygen sensing will exhibit an altered chemoreflex and will be intolerant to high-altitude.
    

Detailed description: 
      Subjects are selected at an outpatient clinic specialised in the diagnosis of tolerance to
      altitude, where the chemoreflex is analyzed during a bicycle exercise performed with a oxygen
      deprived air simulating a 8000 meters altitude.

      All subjects will go later to high altitude for trekking usually. The patients are those
      subjects with an altered chemoreflex who exhibited cerebral edema or pulmonary edema during
      the trekking.

      The controls are the subjects with a normal chemoreflex who did not exhibit any trouble
      during their journey.

      Fourty subjects of each group are included. A blood sample is withdrawn and studied for
      succinate dehydrogenase genes in a blind fashion.

      After completing the inclusion the allelic mutations will be compared in the two groups.
    

Observational model: Defined Population
Time perspective: Retrospective
Keywords: Altitude; Anoxemia; Mitochondria; Reflex; Genetic research
Identifying Brain and Genetic Markers of Sertraline Treatment Response in People With Social Anxiety Disorder
Condition: Anxiety Disorders
MeSH terms: Anxiety Disorders; Phobia, Social
Study type: Observational

Summary: 
      This study will attempt to identify gene and brain activity markers that predict whether
      people with social anxiety disorder will respond to selective serotonin reuptake inhibitor
      medications.
    

Detailed description: 
      Social anxiety disorder (SAD) is an anxiety disorder characterized by excessive fear and
      avoidance of social situations. Selective serotonin reuptake inhibitors (SSRIs) are a
      medication commonly prescribed to treat social anxiety disorder, but as many as 50% of people
      with SAD do not respond to SSRIs. Current theory suggests that neurological functioning and
      genetics may influence a patient's response to treatment. This study will examine variations
      in genetics and brain reactivity among people with SAD who do and do not respond to SSRIs.
      Through this, the study will identify neurological and genetic biomarkers that can predict
      responsiveness to SSRI treatment in people with SAD.

      Participation in this study will last 14 weeks. Both healthy people and people with SAD will
      be recruited to participate. All participants will complete similar study visits at entry,
      within 2 weeks of entry, and 12 weeks after that. The first visit, which will occur at study
      entry, will include screening questionnaires, an interview with research staff, a medical
      screening, a urine test, and collection of saliva samples for genotyping. The second visit
      and the last visit, which will be separated by 12 weeks, will involve MRI scans and
      behavioral tasks to be conducted inside and outside the MRI scanner. Over the 12 weeks
      between MRI scanning sessions, participants with SAD will take sertraline, a common SSRI, on
      a daily basis. They will also attend five additional visits during this time to complete
      assessments of their symptoms. These visits will occur 1, 2, 4, 8, and 12 weeks after
      starting sertraline treatment. Participants with SAD will therefore be completing a symptom
      assessment, MRI scans, and behavioral tasks all on the final visit, 12 weeks after the second
      visit.
    

Intervention name(s): Sertraline
Intervention type(s): Drug
Intervention description(s): Oral sertraline will begin at 50 mg per day, then increase to 75 mg per day on Day 8, then increase to 100 mg per day on Day 15. The dose may be increased to 150 mg per day on Week 8, based on clinical response and medication toleration.
Other intervention name(s): Zoloft
Intervention MeSH terms: Sertraline
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Community and outpatient clinic samples
      
Biospecimen description: 
      Saliva samples
    
Keywords: Anxiety; Social Phobia; Generalized Social Anxiety Disorder
Conditioning Effect of Previous Symptoms on the Responses to Meal Ingestion
Condition: Healthy
Study type: Interventional

Summary: 
      Meal ingestion induces sensations that are influenced by a series of conditioning factors.

      Aim: to determine the conditioning effect of previous digestive symptoms to a standardized
      probe meal.

      Controlled randomized parallel study in healthy subjects on the conditioning effect of
      previous digestive symptoms on the responses to a comfort meal. Digestive symptoms will be
      induced by lipid (or sham) infusion into the intestine. On three separate days, digestive
      sensations (satiety, abdominal bloating, digestive well-being, mood, discomfort) in response
      to a comfort meal will be measured before, during and after the intervention. Primary
      outcome: effect of conditioning on the sensation of digestive well-being measured by -5 to +5
      scale after a comfort meal. Secondary aim: effect of conditioning on abdominal on homeostatic
      sensations (satiety, fullness, discomfort, nausea).

      Participants (16 women, 8 in the intestinal infusion and 8 in the sham intervention) will be
      instructed to eat a standard dinner the day before, to consume a standard breakfast at home
      after overnight fast, and to report to the laboratory, where the comfort meal will be
      administered 4 h after breakfast. Studies will be conducted in a quiet, isolated room. On
      each study day, participants will be intubated with a nasoduodenal feeding tube under
      fluoroscopic control for lipids or sham infusion. A comfort meal will be administered and
      perception of digestive sensations will be measured at 5 min intervals 10 min before and 20
      min after ingestion and at 10 min intervals up to 60 min after the probe meal.
    


Intervention name(s): Lipids infusion; Sham infusion
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Lipids infusion via intestinal tube; Sham infusion via intestinal tube
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: meal ingestion; postprandial responses; hedonic sensations; homeostatic sensations; Conditioning
A Controlled Trial of High Dietary Fiber Intake on Serum Lipids
Condition: Hyperlipidemia
MeSH terms: Hyperlipidemias
Study type: Interventional

Summary: 
      The study evaluates high fiber diet intake in patients with hyperlipidemia.
    

Detailed description: 
      Dietary fiber intake has been shown to have modest effect in lowering cholesterol. However,
      most of these studies were done with 20g/daily fiber intake. Not much is known about high
      dietary fiber intake (30-40 g/day) and serum cholesterol. Also, there have been small studies
      that have shown modest decrease in oxidative stress by increasing dietary fiber intake. The
      goal of our study is to determine the efficacy /safety of high dietary fiber intake in
      raising HDL, lowering LDL, and lowering oxidative stress in patients with hyperlipidemia.
    

Intervention name(s): Uncle Sam Cereal
Intervention type(s): Dietary Supplement
Intervention description(s): two 3/4 cup servings daily of Uncle Sam Cereal dietary instruction on high fiber diet
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: low HDL
Heart Rate Variability and Diabetic Kidney Disease in Type 2 Diabetes Mellitus Patients
Condition: Type2 Diabetes Mellitus
MeSH terms: Kidney Diseases; Diabetic Nephropathies; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Observational

Summary: 
      Several studies have investigated an association between cardiac autonomic neuropathy (CAN)
      and albuminuria, glomerular filtration rate, or both, and hypothesized that CAN is involved
      in the pathogenesis of nephropathy. However, most of these studies had focused on Caucasians
      and were limited to a small number of patients with type 1 diabetes mellitus, or had used a
      conventional Ewing battery of tests based on dynamic cardiovascular maneuvers.Yet, there is
      consistent data showing that Asian diabetic populations, including the Chinese, have a higher
      risk of renal complications than Caucasians do.

      The present study investigated an association between heart rate variability (HRV) parameters
      and diabetic kidney disease (DKD) in Chinese type 2 diabetes mellitus (T2DM) patients,
      specifically through time and frequency domain analyses of HRV and urine albumin creatinine
      ratio (UACR) or estimated glomerular filtration rate (eGFR).
    

Detailed description: 
      present study investigated an association between HRV parameters and DKD in Chinese T2DM
      patients, specifically through time and frequency domain analyses of HRV and UACR or eGFR
    

Intervention name(s): Clinical examination and laboratory measurements
Intervention type(s): Other
Intervention description(s): Subjects were interviewed by a physician regarding their medical history, history of hypoglycemic attacks, smoking status, and alcohol consumption. Concentrations of blood urea nitrogen (BUN) and serum creatinine (SCr) were analyzed by the urease-ultraviolet rate method and picric acid method, respectively. Serum uric acid was determined using the enzymatic colorimetric method. Serum hemoglobin A1c (HbA1c) was measured by liquid enzymatic assay. Urine albumin and urine creatinine were found through immune turbidimetric analysis and the enzymatic method, respectively.
Other intervention name(s): Physical examination and blood urine samples collection
Observational model: Case-Only
Sampling method: Probability Sample
Study population: 
        392 patients of T2DM consecutively recruited from February 2013 to April 2015 in the
        inpatient department of Kunming First People's Hospital.The Institutional Review Board of
        Kunming First People's Hospital approved the study protocol. Adult patients with T2DM who
        had consecutively undergone 24-hour Holter monitoring for HRV analysis were included.
Effect of Yellow Pea Protein and Fibre Added to a High-carb Meal on Glycemic Response and Food Intake
Condition: Obesity; Diabetes
Study type: Interventional

Summary: 
      The investigators hypothesized that consuming isolated yellow pea fibre or protein, alone to
      together, as part of a high-carbohydrate pasta meal, would reduce the blood glucose response
      to the meal compared to a meal without yellow pea components and reduce food intake at a meal
      served 2 hours later.
    


Intervention name(s): Pasta meal with added fractions or control with no fractions
Intervention type(s): Dietary Supplement
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Food intake; satiety; glycemia; appetite; blood glucose; yellow peas; fibre; protein; mixed meal
Study of a Single Primary Dose Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) in Healthy Subjects
Condition: Japanese Encephalitis
MeSH terms: Encephalitis, Japanese; Encephalitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to describe the immunogenicity and safety of IMOJEV® in adult
      and pediatric populations in Vietnam and serve a bridging study to compare immunogenicity,
      reactogenicity, and safety data obtained with IMOJEV® in the Vietnamese population with data
      from other Asian pediatric populations.

      Primary objective:

      - To describe the safety profile of a single dose of IMOJEV®.

      Secondary objectives:

        -  To evaluate the immune response to JE 28 days after the administration of a single dose
           of IMOJEV® in healthy Vietnamese subjects aged from 9 months to 60 years.
    

Detailed description: 
      Study participants will be enrolled by age group and will each receive one injection of
      IMOJEV® on Day 0 given as primary vaccination. They will be assessed for immunogenicity and
      safety, post-vaccination.
    

Intervention name(s): Live attenuated Japanese encephalitis chimeric virus vaccine (IMOJEV®); Live attenuated Japanese encephalitis chimeric virus vaccine (IMOJEV®); Live attenuated Japanese encephalitis chimeric virus vaccine (IMOJEV®); Live attenuated Japanese encephalitis chimeric virus vaccine (IMOJEV®)
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): 0.5 mL, Subcutaneous; 0.5 mL, Subcutaneous; 0.5 mL, Subcutaneous; 0.5 mL, Subcutaneous
Other intervention name(s): IMOJEV®; IMOJEV®; IMOJEV®; IMOJEV®
Intervention MeSH terms: Vaccines
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Japanese Encephalitis; Japanese encephalitis chimeric virus vaccine; IMOJEV®; Live attenuated vaccine