bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Evaluate the Clinical Performance and Safety of an Intra-articular Hyaluronic Acid in Knee Osteoarthritis
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a study to evaluate the Clinical Performance and Safety of a single intra-articular
      (i.a.) injection of hyaluronic acid product (as HL-01) in the treatment of pain due to
      osteoarthritis (OA) of the knee.
    


Intervention name(s): HL-01: high and low molecular weight hyaluronic acid; Placebo
Intervention type(s): Device; Device
Intervention description(s): 2 ml intra-articular single injection; 2 ml intra-articular single injection
Other intervention name(s): Sinovial HL®
Intervention MeSH terms: Hyaluronic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Ultrasound-guided PNB and DPNB for Pediatric Distal Hypospadias Surgery
Condition: Regional Anesthesia; Hypospadias
MeSH terms: Hypospadias
Study type: Observational

Summary: 
      Hypospadias repair is a urological surgical operation that is very painful in the
      postoperative period and requires long-term analgesia. A dorsal penial nerve block (DPNB) and
      pudendal nerve block (PNB), which are regional anesthesia techniques for this operation, are
      used to provide postoperative analgesia.
    

Detailed description: 
      The regional anesthesia techniques used for postoperative analgesia in hypospadias repair
      include the peripheral nerve blocks of pudendal nerve block (PNB) and dorsal penile nerve
      block (DPNB). Ultrasound (US) has recently become increasingly popular in regional anesthesia
      practice and is used to aid these two peripheral nerve block applications in various
      pediatric urological procedures. US-guided DPNB has been shown to provide effective and
      long-term analgesia when compared to caudal epidural block in a recent study on hypospadias
      surgery in the pediatric population.
    

Intervention name(s): Pudendal nerve block group; Dorsal penile nerve block group
Intervention type(s): Procedure; Procedure
Intervention description(s): A 22 Gauge 50 mm insulated needle was then introduced in the anterior-posterior direction at the middle of the ultrasound probe's superior edge with an out-of-plane approach and using an inclination of 15° in the sagittal plane. The needle tip's position was identified by direct visualization using the movement of adjacent anatomical structures.; Half of the total 0.2 ml/kg dose of 0.25% bupivacaine was administered while observing its distribution with US. The same procedure was then repeated on the other side of the penis.
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study was conducted with children who underwent hypospadias surgery at a training and
        research hospital in Istanbul, Turkey.
      
Keywords: Postoperative pain; Ultrasound; Dorsal penile nerve block; Pudendal nerve block; Hypospadias
Safety and Efficacy of AVP-923 in the Treatment of Levodopa-induced Dyskinesia in Parkinson's Disease Patients
Condition: Dyskinesia; Parkinson's Disease
MeSH terms: Parkinson Disease; Dyskinesias
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate the efficacy, safety, and tolerability of AVP-923 capsules containing 45 mg
      dextromethorphan and 10 mg quinidine (AVP-923-45) compared to placebo for the treatment of
      levodopa-induced dyskinesia (LID) in patients with Parkinson's disease (PD).
    

Detailed description: 
      Proof-of-concept phase 2a, double-blind, randomized, placebo-controlled, crossover study.
    

Intervention name(s): AVP-923-45; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): One capsule twice daily for 14 days; One capsule twice daily for 14 days
Other intervention name(s): dextromethorphan/quinidine
Intervention MeSH terms: Quinidine; Dextromethorphan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: levodopa; dyskinesia; parkinson's disease; AVP-923; dextromethorphan; quinidine
Prognosis Analysis of Elderly Donor Liver in Liver Transplantation
Condition: Liver Transplantation; Hepatocellular Carcinoma; Survival
MeSH terms: Carcinoma, Hepatocellular
Study type: Observational

Summary: 
      Based on the follow-up data of elderly donation after cardiac death(DCD) donor liver
      transplant recipients from the CLTR, a database and official website for national data
      gathering. patients who met the enrollment criteria were screened for postoperative
      complications and survival for statistical analysis to understand the prognosis of patients
      and analyze the risk factors affecting their prognosis.
    

Detailed description: 
      Since the Chinese organ donation system was developed in 2015, donation has been the only
      source of organs for transplantation in China. Adult patients (age 18 or older) who underwent
      LT using grafts from deceased donors between January 1st, 2015, and December 31st, 2018, were
      retrospectively identified using the CLTR, a database and official website for national data
      gathering. Based on the follow-up data of elderly DCD donor liver transplant recipients from
      the CLTR, a database and official website for national data gathering. patients who met the
      enrollment criteria were screened for postoperative complications and survival for
      statistical analysis to understand the prognosis of patients and analyze the risk factors
      affecting their prognosis.
    

Intervention name(s): Age
Intervention type(s): Other
Intervention description(s): The study was retrospective and did not involve the application of interventions.
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Adult patients (age 18 or older) who underwent LT using grafts from deceased donors between
        January 1st, 2015, and December 31st, 2018, were retrospectively identified using the CLTR,
        a database and official website for national data gathering.
      
Keywords: elderly donor; liver transplantation; donation after cardiac death; hepatocellular carcinoma; survival
Effects of Two Different Parenteral Nutrition Regimes on Nutrient Intakes, Growth and Plasma Electrolytes in Very Low Birth Weight Infants
Condition: Nutrition Disorder, Infant
MeSH terms: Nutrition Disorders; Infant Nutrition Disorders; Birth Weight
Study type: Observational

Summary: 
      A single-center retrospective observational study comparing two cohorts of very low birth
      weight (VLBW, birth weight < 1500 grams) infants who received parenteral nutrition (PN)
      either before or after a concentrated PN regime was implemented into clinical use. Primary
      outcome is weight SDS at 28 days.
    

Detailed description: 
      This study is a single-center retrospective observational study comparing two cohorts of very
      low birth weight (VLBW, birth weight < 1500 grams) infants who received parenteral nutrition
      (PN) either before or after a concentrated PN regime was implemented into clinical use. Both
      PN regimes were based on standardized PN solutions with the possibility to complement with
      additive nutritional products according to individual assessment by the attending physician.
      To meet recommended macronutrient intakes, in 2012 a concentrated parenteral nutrition regime
      was implemented into clinical use at the neonatal intensive care unit in Umeå University
      hospital, Sweden. However, there is a lack of data on how changes in nutrient intakes affect
      growth and electrolyte status in preterm infants. Recent studies have demonstrated an
      increased incidence of hypokalaemia, hypophosphatemia and hypercalcaemia in infants who
      received enhanced parenteral energy and protein intakes.

      This study is a single-center retrospective observational study comparing two cohorts of very
      low birth weight (VLBW, birth weight < 1500 grams) infants who received parenteral nutrition
      (PN) either before or after a concentrated PN regime was implemented into clinical use. Both
      PN regimes were based on standardized PN solutions with the possibility to complement with
      additive nutritional products according to individual assessment by the attending physician.
    

Intervention name(s): More concentrated parenteral nutrition solution
Intervention type(s): Dietary Supplement
Intervention description(s): This study is a single-center retrospective observational study comparing two cohorts of very low birth weight (VLBW, birth weight < 1500 grams) infants who received parenteral nutrition (PN) either before or after a concentrated PN regime was implemented into clinical use. Both PN regimes were based on standardized PN solutions.
Intervention MeSH terms: Parenteral Nutrition Solutions
Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        All infants VLBW infants admitted to the neonatal intensive care unit at Umeå University
        Hospital, Sweden, within 24 hours after birth and treated there for ≥ 7 days, during 1
        February 2010 and 30 September 2013.
      
Biospecimen description: 
      Blood samples
    
Keywords: preterm
Switch to Maraviroc + Integrase Inhibitor
Condition: HIV
Study type: Interventional
Phase: Phase 3

Summary: 
      This clinical study proposes to evaluate the combination of maraviroc with an integrase
      strand transfer inhibitor (either raltegravir or dolutegravir) in antiretroviral-experienced
      patients to document the efficacy, safety, and tolerability of this combination in order to
      provide clinicians with a treatment regimen that minimizes the risk of metabolic
      complications by avoidance of NRTI/NNRTIs and PIs. The development of an alternative ART
      regimen which lessens the risk of metabolic complications could improve long-term adherence
      and reduce the risk of certain co-morbidities associated with long-term ART use. If this new
      combination is found to be as efficacious as the standard regimen with enhanced tolerability
      and improved metabolic effects, there is great potential for altering the current practice of
      HIV medicine.
    

Detailed description: 
      Description of the study design:

      The study will enroll 30 HIV-infected patients on a stable ART regimen with a suppressed HIV
      RNA < 50 copies/ml for at least one year. Patients will be switched to the experimental
      regimen (maraviroc 300 mg twice a day plus either raltegravir 400 mg twice a day or
      dolutegravir 50 mg once a-day) and followed for 96 weeks. The decision to use raltegravir or
      dolutegravir will be left to investigator/subject preference, as the two integrate inhibitors
      are largely interchangeable aside from twice daily (raltegravir) vs. daily (dolutegravir)
      dosing.

      Primary endpoint:

        -  The primary endpoint is the proportion of patients virologically suppressed (HIV RNA <
           50 copies/ml) at 48 weeks.

      Definitions:

        -  Virologic suppression is an HIV RNA < 50 copies/ml.

        -  Virologic failure is an HIV RNA ≥ 50 copies/ml confirmed on 2 separate occasions,
           separated by > 1 week after viral suppression.

      Secondary endpoints:

        -  The percent change in total cholesterol, LDL, and HDL at 48 and 96 weeks.

        -  The number of adverse events.

        -  The proportion of patients who are virologically suppressed (HIV RNA < 50 copies/ml) at
           96 weeks.

      Exploratory endpoints:

        -  Telomerase activity and telomere length measured at baseline and 24, 48, and 96 weeks.
    

Intervention name(s): Switch to Maraviroc + Raltegravir or Dolutegravir
Intervention type(s): Drug
Intervention description(s): Change HIV-infected patients on stable, suppressed ART regimens for at least 1 year to experimental regimen of Maraviroc + Raltegravir or Dolutegravir for 48 weeks
Intervention MeSH terms: Raltegravir Potassium; Dolutegravir; Maraviroc
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HIV
The Effects of Pythagorean Self-Awareness Intervention on Young Adolescents in Primary School-Α One Arm Clinical Trial
Condition: Stress; Health Promotion; Adolescence
Study type: Interventional

Summary: 
      In this one arm clinical trial, students of the 6th grade in a primary school participated in
      the PSAI for 8 weeks. Self-report questionnaires and hair cortisol concentrations were used
      for the evaluation of the aforementioned variables at baseline and at the end of the
      intervention.
    


Intervention name(s): PSAI-CA
Intervention type(s): Behavioral
Intervention description(s): The intervention is based on the principles of the teaching of the ancient Greek philosopher Pythagoras. These principals set a basic framework for behavior on the basis of experiential learning and weekly evaluation of the implementation of 12 virtues. The technique is practiced twice a day(before night sleep and in the morning before getting up from bed) and evolves into five successive steps;1)reading of the 12 virtues and diaphragmatic breathing, 2)recall every event og the day,3)third person visualization and self-observation, 4)self-dialogue "What have I done wrong?", "What have I done right?", "What have I omitted that I ought to have done?" Endorsement or disapproval of actions according to the 12 virtues and the instructions for a healthy lifestyle, 5) next morning brief revision of the previous night's conclusions and setting of goals for the upcoming day.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: holistic program; self-awareness; Pythagorean Self-Awareness Intervention; PSAI; stress; adolescence; school; bullying; healthy lifestyle; cognitive intervention
Study of Target-Guided Chemotherapy in Metastatic Colorectal Patients
Condition: Progression Free Survival
MeSH terms: Disease Progression
Study type: Interventional
Phase: Phase 2

Summary: 
      Treatment options for patients with colorectal cancer (CRC) have increased in the last years.
      However, there are no validated prospective molecular markers in CRC to select which agents
      are better to treat any individual case. The conventional first-line treatment in CRC
      patients in clinical studies get a proportion of patients free of progression at 12 months
      ranging from 35-40% with a median of 9 months of free disease progression.

      The aim of this study is to demonstrate that the identification of therapeutic targets in
      real time and their prospectively use to customize the treatment get a proportion of
      colorectal metastatic patients patients free of progression disease at 12 months of 50%.
    


Intervention name(s): Tailored Chemotherapy
Intervention type(s): Drug
Intervention description(s): Patients will be treated with Folfox, Folfiri, Xelox or Xeliri and Cetuximab or Bevacizumab at usual doses tailored by:
K-ras native: Cetuximab. K-ras mutated: Bevacizumab Topoisomera 1 positive ( Topo-1): Irinotecan Topo-1 positive and ERCC-1 negative: oxaliplatin Topo-1 1 negative and ERCC-1 positive: investigator option Thimidylate synthase (TS) positive: No Fluoropyrimidines (FLP) TS negative: FLP Thimidylate phosphorylasa (TP) positive: Capecitabine TP negative: 5-FU
Other intervention name(s): Biomarker selection; Therapeutic Targets chemotherapy
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Molecular Targets; Personalize Treatment; Colon Cancer; Complete Response Rate
Dynamic Knee Laxity Measurement Coupled to MRI in Cases of Suspected Partial Anterior Cruciate Ligament Tear
Condition: Anterior Cruciate Ligament Tear
MeSH terms: Anterior Cruciate Ligament Injuries
Study type: Interventional

Summary: 
      Anterior cruciate ligament (ACL) tear is frequent, but the diagnosis of partial tears is
      difficult. Standard MRI may be used but is of limited diagnostic value. The present study
      aimed to evaluate the diagnostic interest of dynamic knee laxity measurement coupled to MRI
      for the diagnosis of ACL tear.
    


Intervention name(s): LaxIRM
Intervention type(s): Device
Intervention description(s): Dynamic knee laxity measurement coupled to MRI for the diagnosis of ACL tear
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: dynamic knee laxity measurement; laxi-MRI; partial anterior cruciate ligament tear
Vismodegib in Treating Younger Patients With Recurrent or Refractory Medulloblastoma
Condition: Recurrent Childhood Medulloblastoma
MeSH terms: Medulloblastoma; Recurrence
Study type: Interventional
Phase: Phase 2

Summary: 
      This phase II trial studies how well vismodegib works in treating younger patients with
      recurrent or refractory medulloblastoma. Vismodegib may slow the growth of tumor cells.
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. Estimate the efficacy of GDC-0449 (vismodegib) treatment for pediatric patients with
      recurrent or refractory medulloblastoma, as measured by the sustained objective response
      rates for patients without (stratum A) and with (stratum B) evidence of activation of
      Hedgehog (Hh) signaling pathway in their tumors.

      II. Characterize the pharmacokinetics (plasma) of GDC-0449 in children/adolescents with
      refractory medulloblastoma.

      III. To document pathologic and genomic methods to identify medulloblastomas with activation
      of the Hh signaling pathway.

      SECONDARY OBJECTIVES:

      I. Document and describe toxicities associated with GDC-0449 administered on a daily
      schedule.

      II. Estimate the duration of objective response and progression-free survival (PFS).

      III. Characterize the pharmacokinetics (cerebrospinal fluid) of GDC-0449 in
      children/adolescents with refractory medulloblastoma.

      OUTLINE: This is a multicenter study. Patients are stratified according to evidence of
      activation of Hedgehog signaling pathway in their tumors (without vs with vs unknown).

      Patients receive vismodegib orally (PO) once daily (QD) on days 1-28. Treatment repeats every
      28 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.

      Plasma and cerebrospinal fluid samples are collected periodically for pharmacokinetic and
      other correlative studies.

      After completion of study treatment, patients are followed up every other month for up to 12
      months.
    

Intervention name(s): Laboratory Biomarker Analysis; Pharmacological Study; Vismodegib
Intervention type(s): Other; Other; Drug
Intervention description(s): Correlative studies; Correlative studies; Given PO
Other intervention name(s): Erivedge; GDC-0449; Hedgehog Antagonist GDC-0449
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Controlling Myopia Progression With Soft Contact Lenses
Condition: Myopia
MeSH terms: Myopia
Study type: Interventional

Summary: 
      This study is to investigate whether novel soft contact lens optical designs can slow myopia
      progression.
    

Detailed description: 
      The study will be a prospective, randomized, single blind, bilateral dispensing study
    

Intervention name(s): Test Lens 1; Test Lens 2; Control Lens
Intervention type(s): Device; Device; Device
Intervention description(s): Investigational soft contact lens with asperic optical design to control myopia progression.; Investigational soft contact lens with asperic optical design to control myopia progression.; Spectacle Lenses.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
3DV+TPS Software Outlines the Radiotherapy of Nasopharyngeal Carcinoma
Condition: Radiotherapy; Nasopharyngeal Carcinoma
MeSH terms: Carcinoma; Nasopharyngeal Carcinoma
Study type: Observational

Summary: 
      Comparing the accuracy and speed of 3DV+TPS software with imported TPS and domestic TPS to
      outline the contours of crisis organs, it is proved that 3DV+TPS has superiority compared
      with domestic TPS, and it has non-inferiority compared with imported TPS, indicating that the
      software can improve contour sketching accuracy. And speed, reduce the burden on doctors,
      improve medical efficiency.
    

Detailed description: 
      Comparing the accuracy and speed difference between 3DV+TPS software and imported TPS and
      domestic TPS to outline the contours of crisis organs, the selected organs are: bilateral
      eyeballs, bilateral crystals, bilateral optic nerves, bilateral parotid glands, oral cavity,
      spinal cord, brainstem, The brain has a total of 12 organs; verify that 3DV+TPS is superior
      to domestic TPS, and has non-inferiority compared with imported TPS, Ming software can
      improve the accuracy and speed of contour sketching, reduce the burden on doctors, and
      improve medical efficiency.
    

Intervention name(s): 3DV+TPS；VARIAN TPS；FonicsPlan
Intervention type(s): Device
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        A total of 7 different grade hospital radiotherapy centers have received radiotherapy for
        patients with nasopharyngeal carcinoma Case information, based on inclusion and exclusion
        criteria, a total of 300 cases were screened. Among them, Xinqiao Hospital collected 180
        cases, He collected 20 cases in 20 hospitals, totaling 200 cases.
Standard Sleeve Pouch Versus Relatively Wide Pouch With Plication
Condition: Obesity, Morbid
MeSH terms: Obesity, Morbid
Study type: Interventional

Summary: 
      three hundred morbidly obese patients candidate for sleeve gastrectomy will divided into
      equal two groups, group A : will operated by standard sleeve gastrectomy on bougie 36 without
      plication of stable line and group B: will operated by sleeve gastrectomy on bougie 42 with
      plication of stable line. the aim is to test the effect of pilcation on the incidence of
      leaks and bleeding
    

Detailed description: 
      three hundred morbidly obese patients candidate for sleeve gastrectomy will divided into
      equal two groups, group A : will operated by standard sleeve gastrectomy on bougie 36 without
      plication of stable line and group B: will operated by sleeve gastrectomy on bougie 42 with
      plication of stable line. the primary outcomes is the incidence of leaks and bleeding which
      is the main nightmare of sleeve gastrectomy, secondary outcome operative time, weight loss
      and metabolic effect
    

Intervention name(s): sleeve with plication; sleeve without plication
Intervention type(s): Procedure; Procedure
Intervention description(s): sleeve with plication; sleeve without plication
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: post sleeve gastrectomy leak; post sleeve gastrectomy