bioihbjkbjnl/mcl2 huggingface dataset:
Functional Magnetic Resonance Imaging (fMRI) for the Study of Response Inhibition, and Face and Linguistic Processing in Autism
Condition: Autism; Asperger's Syndrome
MeSH terms: Autistic Disorder; Asperger Syndrome
Study type: Observational

Summary: 
      This study investigates face processing, response inhibition and phoneme processing in
      autistic adults by fMRI.
    

Detailed description: 
      Fifteen adult outpatients with high functioning autism or Asperger's Syndrome will be
      recruited. Fifteen healthy volunteers matched for age and IQ will also be recruited.
      Participants will undergo an fMRI scan. During the scan they will perform a task. The
      paradigm is designed to test control inhibition, face processing and language. Therefore, it
      includes a go-no go test, a face emotion discrimination test and a linguistic sound. The
      subjects are shown a series of faces with happy or sad expressions in random order. Each face
      presentation is accompanied by either a standard or variant sound. The sound stimulus is the
      English phoneme /oe/. The variant sound was created by raising the frequency of the standard
      sound by 20%. The task consists of four blocks. During each block the subjects are asked to
      press a button when they see a happy or sad face depending on the block. Each block consists
      of 96 trials lasting 2 seconds and an initial and final fixation period of 40 sec. For each
      trial the target image is projected for 500 ms. There is 1250 ms fixation time allowed for
      response and 250 ms for jitter. Twenty-four of the 96 trials are no go trials and 16/96 are
      sound oddball trials. The oddball is at least two trials apart (between two variant sounds
      there are at least two standard sounds). There are 24 faces displayed in total, 12 female and
      12 male. Faces switch every 16 trials. Face genders are balanced. The faces were selected
      with over 80% congruency except for two faces with congruency of over 72%. The correlation
      between sound (2 conditions: standard versus variant) and target condition (go-no go) is
      zero. The task was piloted on healthy controls and autistic adults. All subjects performed
      well.
    

Intervention name(s): fMRI
Intervention type(s): Procedure
Intervention description(s): there is no intervention
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Thirty adults with ASD and 30
      
Keywords: autism; fMRI; response inhibition; face processing; linguistic processing
Study Evaluating the Effects of DVS SR and Duloxetine on the Pharmacokinetics of Desipramine in Healthy Subjects
Condition: Depression; Depressive Disorder; Depressive Disorder, Major
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the effects of multiple doses of DVS SR and
      duloxetine on the pharmacokinetics of a single dose of desipramine in healthy subjects.
    


Intervention name(s): desvenlafaxine SR; desipramine; duloxetine
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Duloxetine Hydrochloride; Desvenlafaxine Succinate; Desipramine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy
Tegafur-Uracil and Leucovorin or S-1 in Treating Patients With Stage III Colon Cancer That Has Been Completely Removed by Surgery
Condition: Colorectal Cancer
MeSH terms: Colonic Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      RATIONALE: Drugs used in chemotherapy, such as tegafur-uracil, leucovorin, and S-1, work in
      different ways to stop the growth of tumor cells, either by killing the cells or by stopping
      them from dividing. It is not yet known whether giving tegafur-uracil together with
      leucovorin is more effective than giving S-1 in treating patients with stage III colon
      cancer.

      PURPOSE: This randomized phase III trial is studying giving tegafur-uracil together with
      leucovorin to see how well it works compared with giving S-1 in treating patients with stage
      III colon cancer that has been completely removed by surgery.
    

Detailed description: 
      OBJECTIVES:

        -  Compare the disease-free survival of patients with stage III colon cancer treated with
           S-1 or tegafur-uracil and leucovorin after curative surgery .

      OUTLINE: Patients are randomized to 1 of 2 treatment arms.

        -  Arm I: Patients receive oral tegafur-uracil and oral leucovorin 3 times daily on days
           1-21. The treatment repeats 5 times every 5 weeks.

        -  Arm II: Patients receive oral S-1 twice daily on days 1-28. The treatment repeats 4
           times every 6 weeks.

      Biological samples are collected for gene expression analysis for identification of
      predictive markers.
    

Intervention name(s): folinate calcium; tegafur-uracil; tegafur-gimeracil-oteracil potassium
Intervention type(s): Drug; Drug; Drug
Other intervention name(s): Leucovorin, leucovorin; UFT; S-1, TS-1
Intervention MeSH terms: Leucovorin; Tegafur; Calcium; Levoleucovorin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: adenocarcinoma of the colon; stage III colon cancer
A Multicentre Trial to Determine the Efficacy of AD 452 in RA Subjects.
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2

Summary: 
      AD 452 is a new drug which is being developed for use in adult patients with RA. It is
      believed that AD 452 may modify the underlying disease of RA as well as improving RA
      symptoms, and in order to establish its efficacy and safety, AD 452 is being tested in a 3
      month study. Patients enrolled in this study will already be taking methotrexate for their RA
      and they will remain on methotrexate throughout the study. An earlier clinical study in 98
      subjects with RA on stable background therapy investigated the pharmacokinetics, safety and
      tolerability of AD 452 taken for one month. The drug was well tolerated and no significant
      drug related adverse events were reported.
    


Intervention name(s): AD 452
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Rheumatoid Arthritis; RA; ACR20 endpoint; Tender/swollen joints; Improvement in pain; Health assessment questionnaire; Profile of mood states
Effects of Eldoa Versus Meckenzie Exercise on Non-specific Low Back Pain Patients
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      To determine the effects of Eldoa and Mckenzie exercises in posture. To determine the effects
      of Eldoa and Mckenzie exercises in ROM.
    

Detailed description: 
      To determine the effects of Eldoa and Mckenzie exercises in pain. To determine the effects of
      Eldoa and Mckenzie exercises in Quality of life.
    

Intervention name(s): Mckenzie extension exercise; Eldoa stretch technique
Intervention type(s): Other; Other
Intervention description(s): Hot pack applied on lumbar region for (ten minute). Mckenzie extension exercise performed 02 sets of 05 repetitions with 45 second hold and 15 sec rest between each set once a day.
TENS is applied on lumbar region for (ten minutes).; Hot pack applied on lumbar region for (ten minute). Eldoa stretch performed 02 sets of 05 repetitions with 45 second hold and 15 second rest between each set once a day.
TENS is applied on lumbar region for (ten minutes).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
A Study to Assess the Safety of GRF6019 Infusions in Subjects With Severe Alzheimer's Disease
Condition: Severe Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the safety, tolerability, and potential cognitive benefit of the
      experimental treatment GRF6019 in subjects with severe Alzheimer's disease.
    

Detailed description: 
      This is a randomized, double-blind, placebo-controlled study to assess the safety,
      tolerability and potential cognitive benefit of GRF6019, a human plasma protein fraction.
      GRF6019 or placebo will be administered intravenously to subjects with severe Alzheimer's
      disease every day for 5 consecutive days. The total study duration for each subject is
      approximately 9 weeks.
    

Intervention name(s): GRF6019; Placebo
Intervention type(s): Drug; Other
Intervention description(s): GRF6019 for IV infusion; Placebo for IV infusion
Other intervention name(s): Normal Saline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Brain Diseases; Nervous System Diseases; Central Nervous System Diseases; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Dementia; Tauopathy
Metabolism and Excretion of Liraglutide in Healthy Male Volunteers
Condition: Diabetes; Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe. The aim of this trial is characterise the metabolic
      profile of liraglutide in plasma, urine, and faeces after a single injection of
      [3H]-liraglutide.
    


Intervention name(s): liraglutide [3H]
Intervention type(s): Drug
Intervention description(s): A single dose of 0.75 mg will be given as a subcutaneous injection
Other intervention name(s): [3H]-liraglutide
Intervention MeSH terms: Liraglutide
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Biostimulation After Tooth Extraction
Condition: Dental Caries in Children; Wound Heal
MeSH terms: Dental Caries
Study type: Interventional

Summary: 
      This study evaluated the effect of low-level laser therapy on postoperative pain and wound
      healing in children undergoing primary molar extractions 40children, 6-10 years of age,
      systemically healthy, and had atraumatic extraction indications of bilateral primary molar
      teeth were included in the study. A randomly selected tooth was extracted under local
      anesthesia in the first session. Only the clot formation on the socket was observed and
      photographed in the control group. Other group extractions were performed 2weeks later. The
      LLLT group was treated with a 980 nm wavelength Doctor Smile Wiser diode laser and
      photographed. Non-epithelialized surface measurements were performed with the ImageJ program.
      Pain assessment was performed with the Wong-Baker Pain Scale. Statistical analyses were
      performed with SPSS software.
    


Intervention name(s): Tooth extraction
Intervention type(s): Other
Intervention description(s): Tooth extractions were performed by a single physician. Topical anesthesia (Xylo-caine, Astra, Södertalje, Switzerland) was applied to the dried mucosa in the area to be lo-calized with the help of an ear stick for 1 minute. Posterior-superior-alveolar nerve block anesthesia and palatal anesthesia were applied for the upper primary molars; Inferi-or-alveolar nerve block anesthesia and lingual anesthesia (Ultracain, Aventis Pharma, Is-tanbul, Turkey) were applied for the lower primary molars. After anesthesia control was achieved, a randomly selected tooth was extracted. Tooth extraction on the other side was performed two weeks later. During the shootings, attention was paid to the traumatic ap-proach. After the control of bleeding was achieved, data were recorded for each group.
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Factors Associated With Mortality in Neonates
Condition: Neonatal Mortality
Study type: Observational

Summary: 
      The purpose of this study is to better understand the factors associated with mortality and
      identify potentially preventable causes of death in neonates who die after receiving health
      care. As a result, an improved neonatal mortality classification system may be defined.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Neonates for whom healthcare was provided.
      
Keywords: Neonatal mortality; Preterm birth; Low gestational age; VLBW
Combination Effect of Nefopam With Propacetamol for Postoperative Pain After Thyroidectomy
Condition: Thyroidectomy; Pain
Study type: Interventional

Summary: 
      Patients undergoing thyroidectomy are suffering not only surgical wound pain but posterior
      neck pain because of neck extension position during the surgery. However, there has been
      little attention of posterior neck pain. Nefopam and Propacetamol have different
      pharmacodynamics and been used for postoperative pain control in thyroidectomy patients. The
      aim of this study is evaluation of combination effect of Nefopam and Propacetamol for acute
      wound pain, posterior neck pain and chronic pain after thyroidectomy.
    


Intervention name(s): Nefopam; Propacetamol
Intervention type(s): Drug; Drug
Intervention description(s): Patients undergoing thyroidectomy receive medications depending on the group allocation 30minutes prior to the surgery end; Nefopam 20mg, Propacetamol 2g, and Nefopam 20mg+Propacetamol 2g. In addition, patients will take the same medication every six hours during POD 1.; Patients undergoing thyroidectomy receive medications depending on the group allocation 30minutes prior to the surgery end; Nefopam 20mg, Propacetamol 2g, and Nefopam 20mg+Propacetamol 2g. In addition, patients will take the same medication every six hours during POD 1.
Intervention MeSH terms: Propacetamol; Nefopam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Polyphenols and Insulin Resistance
Condition: Healthy Volunteers; Insulin Resistance; Type 2 Diabetes (T2D)
MeSH terms: Diabetes Mellitus, Type 2; Insulin Resistance
Study type: Interventional

Summary: 
      Diet and nutrition play an essential role in the development and the clinical expression of
      the most common health problems. Overeating and obesity induce oxidative stress, which has
      been proposed to be a pathogenic mechanism leading to insulin resistance, type 2 diabetes
      (T2D) and associated cardiovascular complications. The main objective of the proposed
      research is to evaluate the beneficial effects of polyphenolic compounds derived from red
      grape marc extracts on the cascade of events leading from overeating to oxidative stress and
      insulin resistance. For that, we will study free radicals production, inflammatory markers,
      adipokines, mitochondrial function, insulin sensitivity and energy substrate utilization in
      healthy volunteers at risk for insulin resistance and T2D (1st degree relatives of T2D
      patients with associated overweight). These volunteers will be randomized between a placebo
      and a polyphenol group for 9 weeks. The demonstration of the beneficial effects of
      polyphenols will be sensitized by high-fructose feeding for the last 6 days of the protocol.
    


Intervention name(s): polyphenol; placebo
Intervention type(s): Drug; Drug
Intervention description(s): 2 capsules of 0.5 gram to be taken at the beginning of breakfast and dinner (2g/day) fructose : dose of 3 g/kg/day from D57 to D62 in the form of a 20% solution taken during the three main meals; 2 capsules of 0.5 gram to be taken at the beginning of breakfast and dinner (2g/day) fructose : dose of 3 g/kg/day from D57 to D62 in the form of a 20% solution taken during the three main meals
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: insulin resistance; type 2 diabetes (T2D); cardiovascular complications; polyphenolic compounds derived from red grape marc extracts; oxidative stress
Safety and Efficacy Study of the NeuGuide Device
Condition: Pelvic Organ Prolapse
MeSH terms: Prolapse; Pelvic Organ Prolapse
Study type: Interventional

Summary: 
      This study aims to investigate the safety, efficacy, peri and postoperative complications,
      and patient satisfaction of sacro-spinous ligament fixation (SSLF) for the management of
      pelvic organ prolapse (POP).

      Prolapse staging for all subjects in this study will be performed according to the POP-Q
      staging system.

      Ultrasound examinations for all subjects in this study are subjected to the surgeon need and
      will be performed if required by qualified personnel
    


Intervention name(s): NeuGuide device
Intervention type(s): Device
Intervention description(s): The NeuGuideTM device is indicated for anchoring sutures to ligaments of the pelvic floor
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Treatment of Cerebellar Ataxia With Mesenchymal Stem Cells
Condition: Cerebellar Ataxia
MeSH terms: Ataxia; Cerebellar Ataxia
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The study is to investigate the efficacy and safety of allogenous transplantation of
      adipose-derived mesenchyma stem cells in patients with cerebellar ataxia.
    


Intervention name(s): Allogeneic adult adipose-derived mesenchymal stem cells
Intervention type(s): Biological
Intervention description(s): Patients will receive intravenously one dose of 5-7x10^7 cells of allogeneic adipose-derived mesenchymal stem cells
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Preventive Effects of Bosentan on the Systemic Cardiovascular Consequence of Sleep Apnea
Condition: Obstructive Sleep Apnea; Hypertension
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional
Phase: Phase 2

Summary: 
      The study will compared the effects of bosentan, an endothelin receptor antagonist, and nasal
      continuous positive airway pressure (nCPAP), obstructive sleep apnea current reference
      treatment, on diastolic blood pressure in untreated mildly hypertensive sleep apnea patients.

      The hypothesis is that blocking endothelin receptors with a drug will have the same systemic
      blood pressure lowering effect than nCPAP in sleep apnea patients.
    


Intervention name(s): bosentan; nasal continuous positive airway pressure (CPAP)
Intervention type(s): Drug; Device
Intervention description(s): 62.5 mg b.i.d for 4 weeks; Daily application throughout sleep for 4 weeks
Other intervention name(s): TRACLEER
Intervention MeSH terms: Bosentan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cardiovascular system; Sleep; Endothelial function; Endothelin system
Testing the Reliability and Validity of the CIBA
Condition: Quality Improvement
Study type: Observational

Summary: 
      The overall objective of the study is to improve the experience for pediatric patients
      undergoing anesthesia inductions. The specific objective for this proposal is to establish
      whether the CIBA tool demonstrates inter-rater reliability and concurrent validity with the
      Induction Compliance Checklist.
    

Detailed description: 
      The proposed research study will assess the reliability and validity of a new tool that is
      being used in the Department of Anesthesia (The Child Induction Behavioral Assessment tool)
      to grade the difficulty of patient behaviors exhibited during anesthesia inductions. The
      Child Induction Behavioral Assessment (CIBA) tool is more succinct than previously validated
      tools for assessing behavioral responses to inhalation inductions, making it practical for
      use in a busy clinical practice setting. Having clinicians document a patient's behavioral
      response to induction using the CIBA tool is useful because this information can help to
      optimize subsequent induction plans if the patient returns. Additionally, population data may
      be collected using electronic data reports for QI purposes. Prior to using data from the CIBA
      tool in QI initiatives, it is important to assess whether this tool is reliable and valid.
    

Intervention name(s): Observing patient behaviors for anesthesia induction compliance
Intervention type(s): Behavioral
Intervention description(s): Observing patient behaviors for anesthesia induction compliance so to test reliability and validity of the CIBA Tool
Intervention MeSH terms: Anesthetics
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        patients aged 1 to 13 years undergoing inhalation inductions for general anesthesia
Single Bundle Anterior Cruciate Ligament Reconstruction in Active Young Men
Condition: Anterior Cruciate Ligament Rupture
MeSH terms: Rupture
Study type: Interventional

Summary: 
      The clinical outcomes of anterior cruciate ligament reconstruction using free tendon Achilles
      allograft are comparable to those using Achilles allograft with bone block on its end.
    


Intervention name(s): anterior cruciate ligament reconstruction
Intervention type(s): Procedure
Intervention description(s): single bundle anterior cruciate ligament reconstruction with Achilles allograft
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: anterior cruciate ligament; Achilles; free tendon; bone-tendon; free tendon Achilles allograft; Achilles allograft with calcaneal bone block on its end
A PHASE I, RANDOMIZED, PLACEBO-CONTROLLED, SINGLE DOSE ESCALATION STUDY TO INVESTIGATE SAFETY, PHARMACOKINETICS AND PHARMACODYNAMICS OF SHR0534 IN HEALTHY VOLUNTEERS
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, placebo-controlled, single dose escalation study to investigate the
      safety, tolerability, pharmacokinetics and pharmacodynamics of SHR0534. The study will be
      conducted with starting dose of 10 mg followed by dose escalation groups up to 200 mg. Eight
      subjects will be randomized in 3:1 ratio in each cohort to receive the study drug or placebo.
    


Intervention name(s): SHR0534; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment