bioihbjkbjnl/mcl2 huggingface dataset:
Acute Myocardial Dysfunction and Chest Trauma - The Strainy Trauma Study
Condition: Chest Trauma
MeSH terms: Wounds and Injuries; Thoracic Injuries
Study type: Observational

Summary: 
      This study aims to investigate whether the identification of acute myocardial dysfunction by
      2D-strain transthoracic sonography in the first week following trauma would allow to better
      diagnose occult and severe patterns of myocardial contusion, in order to identify a
      subpopulation at higher risk of complications.

      The measurement of myocardial strain (2D-strain) by transthoracic sonography is a robust tool
      to assess the myocardial function.

      The investigators strongly suppose that the 2D-strain would allow to better identify
      subclinical MC in chest trauma, as well as the severe patterns that are associated with more
      organs dysfunctions and a worst outcome.
    

Detailed description: 
      Thoracic trauma is the cause of significant morbidity and accounts for 25% of trauma-related
      deaths.

      The myocardial contusion (MC) is a distinct injury, which has a prevalence increasing with
      the severity of the trauma. The diagnostic tool is a major factor to vary the prevalence of
      MC (i.e. clinical exam, biology, electrocardiogram), with the highest values for autopsy
      series, until 24% of patients. It does not exist therefore of gold standard for the diagnosis
      of MC in clinical practice leading to a modest knowledge of this nosological entity. In
      clinical practice, troponin plasma level determines the diagnostic.

      Otherwise, the measurement of myocardial strain (2D-strain) by transthoracic echocardiography
      (TTE) is a robust tool to assess the myocardial function. This ultrasound analysis allows an
      objective and topographical quantification of an acute myocardial dysfunction, be it global
      or segmental. 2D-strain has been thus has been validated for the diagnosis of myocardial
      dysfunction in medical setting. Its use in trauma setting has never been reported.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Severe trauma patients with blunt chest trauma
      
Keywords: Severe trauma; chest trauma
A Phase 1 Study of Novel GS-9973 Tablet Formulations to Evaluate the Effect of Acid Reducing Agents, Relative Bioavailability, and Food Effect on GS-9973 Pharmacokinetics
Condition: Chronic Lymphocytic Leukemia
MeSH terms: Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, Open-Label, Adaptive Study of Novel GS-9973 Tablet Formulations to
      Evaluate the Effect of Acid Reducing Agents, Relative Bioavailability, and Food Effect on
      GS-9973 Pharmacokinetics.
    


Intervention name(s): Treatment A; Treatment B; Treatment C; Treatment D; Treatment E; Treatment F; Treatment G; Treatment H; Treatment I; Treatment J
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 1600 mg GS-9973 (Formulation 1); 1600 mg GS-9973 (Formulation 1) plus 20 mg omeprazole; 1600 mg GS-9973 (Formulation 1) plus 40 mg famotidine; 1600 mg GS-9973 (Formulation 2); 1600 mg GS-9973 (Formulation 2) plus 20 mg omeprazole; 1600 mg GS-9973 (Formulation 2) plus 40 mg famotidine; 1600 mg GS-9973 (Reference formulation); 1600 mg GS-9973 (Formulation 1 or Formulation 2, based on results from Part A); An alternate dose of the chosen formulation from Part A up to 1200 mg administered twice-daily; An alternate dose of the chosen formulation from Part A up to 1200 mg administered twice-daily
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chronic Lymphocytic Leukemia; CLL
Effect of a Modified Ketogenic-Mediterranean Diet on Alzheimer's Disease
Condition: Mild Cognitive Impairment; Insulin Resistance
MeSH terms: Alzheimer Disease; Insulin Resistance; Cognitive Dysfunction
Study type: Interventional

Summary: 
      The purpose of the BEAM study is to compare the effects of a low-carbohydrate diet and a
      lowfat diet for adults with mild memory loss and adults with pre-diabetes. The data collected
      will help determine changes in cognitive function, brain structure and function, and levels
      of certain proteins and hormones in body fluids.
    

Detailed description: 
      Participants will be enrolled into 1 of 3 study groups. Group 1 will include healthy
      volunteers with no apparent memory problems, memory complaints or family history of
      Alzheimer's disease or dementia. This group will complete cognitive assessments, blood and
      stool sample collection, neuroimaging, and lumbar puncture at week 0 only. Group 1 will NOT
      take part in the diet study.

      Group 2 will have pre-diabetes, but no apparent memory problems that can be observed during
      cognitive testing. Group 2 will complete an 18-week diet study, with follow-up assessment 6
      weeks after final diet completion. Throughout the study the following will also be completed;
      cognitive assessments, blood and stool sample collection, neuroimaging, and lumbar puncture.

      Group 3 will have mild memory problems that are observed during cognitive testing. Group 3
      will complete an 18-week diet study, with follow-up assessment 6 weeks after diet final
      completion. Throughout the study the following will also be completed; cognitive assessments,
      blood and stool sample collection, neuroimaging, and lumbar puncture.
    

Intervention name(s): Low-Carbohydrate Diet; Low-Fat Diet
Intervention type(s): Other; Other
Intervention description(s): Participants assigned to the Modified Ketogenic-Mediterranean Diet will keep their carbohydrate consumption below 20 grams per day throughout the 6-week intervention.; Participants assigned to the Low-Fat Diet will be encouraged to limit their amount of fat intake to <40 grams/day, while eating plentiful fruits, vegetables, and carbohydrates containing adequate fiber.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Assessment of the Therapeutic Utility of r-FSH in Association With hMG-HP
Condition: Sterility
MeSH terms: Infertility
Study type: Observational

Summary: 
      To assess the effectiveness of a protocol of ovarian hyperstimulation combining urinary
      gonadotrophins + recombinant gonadotrophins, to achieve clinical pregnancy in females
      undergoing IVF.

      Study hypothesis: to assess the effectiveness of protocols combining urinary gonadotrophins +
      recombinant gonadotrophins
    


Intervention name(s): hMG-HP/r-FSH
Intervention type(s): Drug
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Females affected by sterility able to undergo IVF
Randomized Controlled Trial of Gemcitabine Combined With 125I Brachytherapy
Condition: Locally Advanced Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      For patients with unresectable locally advanced pancreatic cancer, the combined use of
      external-beam radiation therapy (EBRT) and systemic chemotherapy of 5-FU has been widely
      recognized as the most effective chemoradiotherapy approach.But most patients succumb to
      local recurrence and metastasis after treatment, and the prognosis remains poor On the basis
      of the development and superiority of the interstitial brachytherapy and the radiosensitizing
      effect of gemcitabine, we performed a clinical study to explore the interaction of improved
      I-125 brachytherapy and gemcitabine and compare the regimen to the standard gemcitabine
      treatment specifically in patients with non-metastatic, unresectable pancreatic cancer.
    


Intervention name(s): gemcitabine; 125I brachytherapy PLUS gemcitabine
Intervention type(s): Drug; Other
Intervention description(s): a 30-minute intravenous infusions of gemcitabine 1,000 mg/m2 weekly×7, followed by a 1-week pause, and then weekly×3; 125I brachytherapy PLUS a 30-minute intravenous infusions of gemcitabine 1,000 mg/m2 weekly×7, followed by a 1-week pause, and then weekly×3
Intervention MeSH terms: Gemcitabine
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: pancreatic cancer; locally advanced
Clinical Bioequivalence Study on Two Paracetamol Tablet Formulations
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of the study is to compare the bioavailability of a generic product of
      paracetamol (immediate-release) with that of a reference product when administered to healthy
      volunteers under fasting condition. The test product is Fortolin Tab 500mg manufactured by
      Fortune Pharmacal Co. Ltd., and the reference product is Panadol Caplet 500mg manufactured by
      GlaxoSmithKline (Dungarvan) Ltd. The plasma pharmacokinetic data of paracetamol obtained from
      two formulations will be used to evaluate the interchangeability of the products.
    


Intervention name(s): Fortolin Tab 500mg; Panadol Caplet 500mg
Intervention type(s): Drug; Drug
Intervention description(s): Fortolin Tab 500mg is a generic product manufactured by Fortune Pharmacal Co. Ltd.; Panadol Caplet 500mg is manufactured by GlaxoSmithKline (Dungarvan) Ltd.
Other intervention name(s): Acetaminophen Tablet 500mg; Acetaminophen Caplet 500mg
Intervention MeSH terms: Acetaminophen
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Study to Evaluate the Relative Bioavailability of Fixed-dose Combination Tablet Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) as a Whole Tablet, as a Split Tablet, and as Crushed Tablet in Healthy Adult Participants
Condition: Healthy
MeSH terms: Crush Injuries
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the single-dose pharmacokinetics and relative
      bioavailability of Darunavir (DRV) 800 milligram (mg), Cobicistat (COBI) 150 mg,
      Emtricitabine (FTC) 200 mg, and tenofovir alafenamide (TAF) 10 mg when administered as a
      fixed-dose combination (FDC) (D/C/F/TAF) tablet in healthy adult participants when given as
      Treatment A (reference): a single dose of D/C/F/TAF (800/150/200/10 mg) FDC tablet swallowed
      as a whole, intact tablet with 240milliliter (mL) of noncarbonated water.Treatment B (test):
      a single dose of D/C/F/TAF (800/150/200/10 mg) FDC tablet as a split tablet swallowed with
      240 mL of noncarbonated water. Treatment C (test): a single dose of D/C/F/TAF (800/150/200/10
      mg) FDC tablet as a crushed tablet mixed in 4 ounces (oz) of applesauce.
    


Intervention name(s): Darunavir (DRV); Cobicistat (COBI); Emtricitabine (FTC); Tenofovir Alafenamide (TAF)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Darunavir 800 milligram (mg) will be taken orally in FDC together with COBI(150mg)/FTC(200mg)/TAF(10mg).; Cobicistat 150 milligram (mg) will be taken orally in FDC together with DRV(800mg)/FTC(200mg)/TAF(10mg).; Emtricitabine 200 milligram (mg) will be taken orally in FDC together with COBI(150mg)/DRV(800mg)/TAF(10mg).; Tenofovir Alafenamide 10 milligram (mg) will be taken orally in FDC together with COBI(150mg)/FTC(200mg)/DRV(800mg).
Intervention MeSH terms: Tenofovir; Emtricitabine; Darunavir; Cobicistat
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Trial of Probiotics for Constipation in Parkinson's Disease
Condition: Parkinson Disease
MeSH terms: Parkinson Disease; Constipation
Study type: Interventional

Summary: 
      This is a double blinded randomised placebo controlled trial to evaluate the efficacy of
      probiotics in the treatment of constipation in Parkinson's disease.
    


Intervention name(s): Probiotic Capsule; Placebo Capsule
Intervention type(s): Drug; Drug
Intervention description(s): Probiotic - one capsule a day for four weeks; Placebo - one capsule a day for four weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Placebo Controlled
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Consequences of Hypoglycemia on Intensive Care Unit (ICU) Patients
Condition: Critical Illness
MeSH terms: Hypoglycemia; Critical Illness
Study type: Observational

Summary: 
      Hypoglycemia occurs frequently during intensive blood glucose control in critically ill
      patients. The incidence of hypoglycaemia is associated with impaired outcome. However, it is
      hitherto unknown if hypoglycaemia itself predisposes patients to neurological impairment,
      e.g. cognitive dysfunction, or if it is the underlying medical condition that makes the
      patient prone to a high risk of hypoglycaemia and, concomitantly, neurocognitive impairment.
      Therefore we investigate neurocognitive function in patients who had hypoglycemias during
      their intensive care stay and compare the results to patients without hypoglycaemia whose
      medical conditions are matched to the hypoglycaemia patients.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        All patients who were admitted to the hospital ICU after 2003 are screened for hypoglycemia
      
Keywords: critical illness; hypoglycemia; neurocognitive dysfunction; intensive insulin therapy
The Chinese Registration Study of Driver Ablation of Persistent Atrial Fibrillation.
Condition: Atrial Fibrillation, Persistent
MeSH terms: Atrial Fibrillation
Study type: Interventional

Summary: 
      This is an open label, multi-center, randomized parallel control clinical trial, to
      demonstrate the role of driver mechanism in maintenance substrate of persistent atrial
      fibrillation, and evaluate the clinical outcomes of driver mapping and ablation strategy in
      patients with persistent atrial fibrillation.
    

Detailed description: 
      This is an open label, multi-center, randomized parallel control clinical trial. Patients
      with persistent atrial fibrillation are 1:1 randomized into the experimental group (driver
      ablation+ circumferential pulmonary vein isolation) or the control group (stepwise ablation).
      Postoperative atrial fibrillation recurrence rate and other indicators are analyzed to
      demonstrate the role of driver mechanism in maintenance substrate of persistent atrial
      fibrillation and evaluate the clinical outcomes of driver mapping and ablation strategy in
      patients with persistent atrial fibrillation.
    

Intervention name(s): Driver ablation+CPVI; Stepwise ablation
Intervention type(s): Procedure; Procedure
Intervention description(s): Patients receive driver ablation and CPVI (circumferential pulmonary vein isolation).; Patients receive stepwise ablation.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Persistent Atrial Fibrillation; Driver ablation; Stepwise ablation
(CB-01-02/01) Randomized Placebo Controlled Trial of Budesonide-multi-matrix System (MMX™) 6 mg and 9 mg in Patients With Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare Budesonide MMX™ 6 mg and Budesonide MMX™ 9 mg tablets
      to placebo and to Asacol 6x 400 mg tablets over an 8-week treatment period to determine if
      Budesonide MMX™ is effective in the treatment of ulcerative colitis.
    

Detailed description: 
      Each patient will receive one of the following regimens in the morning after breakfast:

        1. one budesonide-MMX™ 6 mg tablet plus two placebo Asacol® over encapsulated tablets, or

        2. one budesonide-MMX™ 9 mg tablet plus two placebo Asacol® over encapsulated tablets, or

        3. two placebo Asacol® over encapsulated tablets plus one placebo budesonide tablet, or

        4. two Asacol® 400 mg over encapsulated tablets plus one placebo budesonide tablet, daily
           for 8 weeks.

      Each patient will also receive on each day after the midday meal and after the evening meal
      either:

        -  two Asacol® 400 mg over-encapsulated tablets (Group 4), or

        -  the equivalent placebo Asacol® over-encapsulated tablets, (Groups 1, 2 and 3)

      Hence, each patient is to take seven tablets per day of active or placebo study medication as
      per the randomization schedule. Placebo tablets of budesonide-MMX™ and placebo
      over-encapsulated tablets of Asacol® will be used to maintain the study blind using a
      double-dummy technique.

      During the study, five visits to the clinical center are scheduled: one at Screening and
      three in the double-blind treatment period (Day 1, Day 14, Day 28 and Day 56). A safety
      follow up visit will take place about 2 weeks after the final study visit. If a patient is
      withdrawn from the study before Day 56, they will be asked to attend the study center as soon
      as possible thereafter so that the Final visit assessments can be conducted.
    

Intervention name(s): Blood sampling, endoscopy; budesonide-MMX® 6 mg; budesonide-MMX® 9 mg; Placebo; Asacol® 400 mg
Intervention type(s): Procedure; Drug; Drug; Drug; Drug
Intervention description(s): Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores; 6 mg/day, 6 mg tablets; 9 mg/day, 9 mg tablets; Placebo; 2400 mg/day, 400 mg tablets
Intervention MeSH terms: Budesonide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Ulcerative colitis
Effect of Orthokeratology on Myopia Progression in French Children
Condition: Myopia Progression
MeSH terms: Myopia; Disease Progression
Study type: Observational

Summary: 
      To evaluate and to compare the effect of orthokeratology (OK) on axial elongation in French
      myopic children.
    


Intervention name(s): orthokeratology; single-vision spectacle correction
Intervention type(s): Device; Device
Intervention description(s): rigid contact lenses; simple wear of spectacle
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        64 consecutive myopic children who underwent OK treatment or single-vision spectacle
        correction at a private ophthalmology clinic in Nancy from November 2019 to December 2020
Effects of Anesthetic Infusion on the Amplitude of Motor Evoked Potential in Pediatrics Undergoing Tethered Spinal Cord Surgeries
Condition: Tethered Cord
Study type: Interventional
Phase: Phase 1

Summary: 
      The tethered spinal cord is a common pathology in pediatric neurosurgery. Intraoperative
      neurophysiologic monitoring (IOM) has gained popularity over the past two decades as a
      clinical discipline that uses neurophysiologic techniques to detect and prevent iatrogenic
      neurologic injuries. IOM techniques are extensively used in adult neurosurgery and, in their
      principles, can be applied to the pediatric population. Inhalational agents cause a
      dose-dependent reduction in MEPs and are arguably considered incompatible with effective
      neurophysiological monitoring(5) For this reason, total intravenous anesthesia (TIVA), using
      IV anesthetics (propofol or ketamine) and opioids (fentanyl or remifentanil), is commonly
      used in spinal surgeries under MEPs monitoring
    

Detailed description: 
      A combination of ketamine and dexmeditomidine has several benefits in terms of hemodynamic
      stability, absence of respiratory depression, postoperative analgesia, and recovery. (11)
      ketamine could prevent the decrease of blood pressure and heart rate which had been observed
      with dexmedetomidine. In addition, dexmedetomidine could prevent the increase of blood
      pressure and heart rate, salivation, and physiological emergence reaction from ketamine. This
      combination was not previously used in this type of procedure except in a case report
      performed by Rozzana Penny who had used dexmedetomidine and ketamine infusion during
      scoliosis repair surgery with somatosensory and motor evoked potential monitoring in 15 years
      old female.(10) Evoked potentials are highly sensitive to fluctuations in physiological
      parameters such as peripheral and core body temperature, arterial blood pressure, hematocrit,
      etc. Keeping in view all the above factors we plan this study to compare the effect of the
      combinations of propofol and fentanyl versus the combination of ketamine and dexmedetomidine
      and fentanyl in producing a minimum effect on MEP amplitude and on hemodynamic stability
      during the surgery.
    

Intervention name(s): ketamine and dexmeditomidine combination; Propofol
Intervention type(s): Drug; Drug
Intervention description(s): Dexmedetomidine( 0.4 -0.6 μg/.kg /.hr)) ketamine,( 1 -2m/.kg/.hr) infusion; propofol (100 ug /kg/min) infusion
Intervention MeSH terms: Ketamine; Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: forty six Children undergoing untethered spinal cord surgery will be randomly allocated into two equal groups using computerized generated random tables.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Health Services Research
Lesser Toe PIP Joint Arthrodesis Versus Resection Arthroplasty
Condition: Claw Toe; Lesser Toe Deformity
MeSH terms: Hammer Toe Syndrome; Congenital Abnormalities
Study type: Interventional

Summary: 
      Background: The aim of this study was to compare operative outcomes after lesser toe
      deformity correction with either proximal interphalangeal (PIP) joint arthrodesis or PIP
      joint resection arthroplasty.

      Methods: A prospective randomized controlled trial was performed on 37 patients (48 toes) who
      underwent one of these two procedures. The Numeric Rating Scale (NRS) for pain, American
      Orthopaedic Foot and Ankle Society (AOFAS) score, osseous consolidation, and clinical outcome
      were evaluated preoperatively and at 6 weeks and 6 months postoperatively.
    


Intervention name(s): Arthrodesis; Resection arthroplasty
Intervention type(s): Procedure; Procedure
Intervention description(s): see study group description; see study group description
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: lesser toe deformity; claw toe; PIP joint; arthrodesis; resection arthroplasty