bioihbjkbjnl/mcl2 huggingface dataset:
Proton Beam Radiation Therapy in Treating Young Patients Who Have Undergone Biopsy or Surgery for Medulloblastoma or Pineoblastoma
Condition: Brain and Central Nervous System Tumors; Long-term Effects Secondary to Cancer Therapy in Children
MeSH terms: Nervous System Neoplasms; Central Nervous System Neoplasms; Medulloblastoma; Pinealoma
Study type: Interventional

Summary: 
      RATIONALE: Specialized radiation therapy that delivers radiation directly to the area where a
      tumor was surgically removed may kill any remaining tumor cells and cause less damage to
      normal tissue.

      PURPOSE: This phase II trial is studying how well proton beam radiation therapy works in
      treating young patients who have undergone biopsy or surgery for medulloblastoma or
      pineoblastoma.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the 3-year incidence and severity of ototoxicity in young patients with
           medulloblastoma or pineoblastoma treated with adjuvant proton beam craniospinal and
           posterior fossa radiotherapy.

        -  Determine the incidence of primary hypothyroidism and other endocrine dysfunction
           (neuroendocrine and end organ) in patients treated with this regimen.

        -  Determine the incidence and severity of neurocognitive abnormalities in patients treated
           with this regimen.

        -  Determine the acute side effects of this regimen, including esophagitis, upper and lower
           gastrointestinal tract disease, and weight loss, in these patients.

        -  Determine the 3-year progression-free survival rate of patients treated with this
           regimen.

      OUTLINE: Patients are stratified according to risk (standard vs high).

      Patients receive proton beam craniospinal and posterior fossa radiotherapy once daily 5 days
      a week for 6-8 weeks*.

      NOTE: *Unless otherwise specified by a co-existing protocol.

      Patients undergo neurocognitive evaluation at baseline or within 3 months after completion of
      radiotherapy and then at 1, 3, and 5 years. Patients also undergo endocrine evaluation at
      baseline and then annually for 5 years; and audiology evaluation at baseline, before each
      course of cisplatin-based chemotherapy (if receiving this), and then annually for 5 years.

      After completion of study treatment, patients are followed every 3-6 months for 2-5 years.

      PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.
    

Intervention name(s): radiation therapy
Intervention type(s): Radiation
Intervention description(s): Radiation therapy with proton beam to standard doses
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: long-term effects secondary to cancer therapy in children; untreated childhood medulloblastoma; untreated childhood pineoblastoma
Adult Stem Cell Therapy for Repairing Articular Cartilage in Gonarthrosis
Condition: Osteoarthritis, Knee; Knee Injuries; Joint Diseases; Rheumatic Diseases; Cartilage Diseases
MeSH terms: Osteoarthritis; Osteoarthritis, Knee; Rheumatic Diseases; Joint Diseases; Cartilage Diseases; Collagen Diseases; Knee Injuries
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a prospective, open-label, single-dose, single-arm phase I-II study in which 15
      patients diagnosed with gonarthrosis grade II-III (Kellgren and Lawrence) will enter the
      study with the primary objective of assessing the feasibility and safety of the knee
      articular infiltration of autologous bone marrow mesenchymal stem cells (MSC). Secondary
      objectives are to assess the efficacy by imaging procedures and clinical questionnaires.

      MSC obtained from each patient's bone marrow will be isolated and expanded "Ex-Vivo" under
      GMP conditions at Xcelia-División de Terapias avanzadas del Banc de Sang I Teixits. After 21
      days, patients will be implanted a single-dose of approximately 40 millions of autologous MSC
      in the knee by articular injection, and followed up for 12 month. Articular cartilage changes
      will be determined by T2-weighted MRI (Cartigram) at 6 and 12 month. Clinical assessment will
      measure the pain by the visual analogue scale (VAS), the self-reported functional status by
      Heath Assessment Questionnaire (HAQ), and the quality of life by Short Form 36 questionnaire
      (SF-36) at 3, 6 and 12 month.

      The working hypothesis proposes that the expected regenerative articular cartilage effect of
      the MSC will be produced to a measurable degree by imaging procedures and clinical
      questionnaires.
    


Intervention name(s): Autologous MSC knee implantation
Intervention type(s): Other
Intervention description(s): Isolation and "Ex-Vivo" expansion of Mesenchymal stem cells (MSC) obtained from each patient's bone marrow under GMP conditions at Xcelia-División de Terapias avanzadas del Banc de Sang I Teixits. After 21 days, approximately 40 millions of autologous MSC will be implanted in the knee by articular injection.
Other intervention name(s): Xcel-m-condro-alpha
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cell therapy; Regenerative therapy; Advance therapy; Bone marrow; Mesenchymal stem cell; Autologous; Interventional clinical trial; Osteoarthrosis; Osteoarthritis; Knee
Noninvasive Methods in Diagnosing Coronary Heart Disease in Diabetic Patients
Condition: Type 2 Diabetes
MeSH terms: Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia
Study type: Observational

Summary: 
      The purpose of this study is to investigate the prevalence of cardiac disease/coronary artery
      disease and diagnostic yield of different non-invasive methods in patients with type 2
      diabetes 40-75 years of age at examination. Exercise tests, Doppler echocardiographic
      examination with Tissue Velocity Imaging, stress Echocardiography, transthoracic Doppler of
      coronary arteries with coronary flow reserve, and cardiac MRI with late enhancement at rest,
      and perfusion after vasodilatation stress will be used in the study. A subpopulation will in
      addition measure forearm vasodilation(FMD) and CFR before and after 4 months of exercise
      training.
    


Intervention name(s): Diagnostic
Intervention type(s): Other
Intervention description(s): Diagnostic non-invasive tests:Dopplerechocardiography, cardiac MRI
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Type 2 diabetes without known cardiac disease between 40 and 75 years of age
      
Biospecimen description: 
      Routine laboratory tests, parameters to caracterize diabetes controle, inflammatory markers.
Insulin Glargine "All to Target" Trial
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary objectives were:

        -  To demonstrate the superiority of Lantus plus stepwise addition of mealtime Apidra®
           (Lantus/Apidra-3) versus twice-daily Premixed insulin based on the proportion of
           patients achieving target glycemic control (as measured by hemoglobin A1c [HbA1c] <7.0%)
           at Week 60

        -  To demonstrate the noninferiority of Lantus plus addition of 1 mealtime Apidra injection
           (Lantus/Apidra-1) versus twice-daily Premixed insulin based on the reduction from
           Baseline to Week 60 in HbA1c
    


Intervention name(s): Insulin Glulisine; Insulin Glargine; Premixed Insulin; Insulin Glulisine
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Subcutaneous injection up to 1 injection per day; Subcutaneous injection once-a-day; Subcutaneous injection twice-a-day.; Subcutaneous injection up to 3 injections per day.
Other intervention name(s): Apidra; Lantus; Novolog Mix 70/30; Apidra
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine; Insulin glulisine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Bioequivalence Study of ARQ 197 Amorphous and Crystalline Polymorphs A and B in Normal Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a bioequivalence study designed to compare three solid states of ARQ 197 in normal
      healthy volunteers using a randomized crossover design.
    

Detailed description: 
      This is a bioequivalence study designed to compare three solid states of ARQ 197 in normal
      healthy volunteers using a randomized crossover design.

      The primary objective is to obtain pharmacokinetic data to assess bioequivalence among three
      solid states of ARQ 197: amorphous, crystalline polymorph A and crystalline polymorph B.
    

Intervention name(s): ARQ 197
Intervention type(s): Drug
Intervention description(s): Treatment with ARQ 197
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Rehabilitation Program to Increase Balance and Mobility in Ataxia of Charlevoix-Saguenay
Condition: Autosomal Recessive Spastic Ataxia of Charlevoix-Saguenay
MeSH terms: Muscle Spasticity; Ataxia; Cerebellar Ataxia; Spinocerebellar Ataxias
Study type: Interventional

Summary: 
      This exploratory study used a pre-post test design. The supervised rehabilitation program was
      performed three times a week for 8 weeks (two sessions at a rehabilitation gym and one pool
      session). Outcome measures included Ottawa sitting scale, 30-Second Chair Stand test, Berg
      Balance Scale, 10-Meter Walk Test, 6-minute Walk Test, modified Activities-specific Balance
      Confidence Scale and SARA scale. 10 participants will complete the training program. They
      will be evaluated at baseline, at week 4 (miway) and after the program.
    


Intervention name(s): Training program
Intervention type(s): Other
Intervention description(s): 8-week rehabilitation program aimed at increasing trunk and lower limb motor control on balance and walking abilities, and accomplishment of activities of daily living.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Safety and Efficacy of the ToothWave -12 Weeks Calculus Study
Condition: Gingivitis; Plaque; Calculus, Dental
MeSH terms: Gingivitis; Dental Calculus; Calculi
Study type: Interventional

Summary: 
      The objective of the study is to evaluate the safety and efficacy of the home-use device
      Silk'n toothbrush (ToothWave) for the improvement in dental health through the reduction of
      plaque, gingivitis, and calculus.
    

Detailed description: 
      This is a single blind, prospective study aimed to evaluate the safety and efficacy of the
      Silk'n toothbrush in reduction of gingivitis, dental plaque and calculus.

      The study includes a total of 168 treatment sessions, twice a day, and 5 clinic visits over a
      period of 12 weeks.

      One treatment group (Silk'n toothbrush - ToothWave) and 1 control group (an ADA approved
      power toothbrush (PTB)) will participate in the study.

      For each patient, assessment data will be collected at baseline, 4 weeks, and at 6 weeks.
      Calculus condition will be measured after 12 weeks in addition to the other timepoints. The
      average data sets will be calculated for each group.

      Treatment is defined as a timed 2 minutes of teeth brushing in a regular manner, twice a day
      (morning and evening). Brushing will be undertaken using the Silk'n toothbrush and standard
      fluoride toothpaste. The control group will use a regular PTB and standard fluoride
      toothpaste.
    

Intervention name(s): RF-utilizing powered toothbrush; Control placebo with no RF
Intervention type(s): Device; Device
Intervention description(s): RF-utilizing Powered toothbrush; Placebo control, toothbrush with no RF
Other intervention name(s): RF toothbrush
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Single blind prospective study
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Combination of Continuous Femoral Block and Intravenous Parecoxib For Postoperative Analgesia After Total Knee Arthroplasty
Condition: POSTOPERATIVE ANALGESIA FOR TKA PARECOXIB/CFB
MeSH terms: Agnosia
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Combination of continuous femoral block with parEcoxib vs placebo. Investigation of morphine
      consumption, opioid sparing effects, VAS pain scores, haemodynamics, Anxierty scores,
      transfusion requirements , Range of motion and rehabilitation parameters between two groups
    


Intervention name(s): Parecoxib; CONTINUOUS FEMORAL BLOCK WITH ROPIVACAINE 0,2%; N/S 0.9%
Intervention type(s): Drug; Drug; Drug
Other intervention name(s): DYNASTAT; NAROPEINE; PLACEBO
Intervention MeSH terms: Parecoxib; Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: PARECOXIB; CONTINUOUS FEMORAL BLOCK
Clinical Effectiveness of Combining Mindfulness-Based Stress Reduction With Exercise Interventione
Condition: Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional

Summary: 
      This study is to assess the clinical effectiveness of combining Mindfulness-Based Stress
      Reduction (MBSR) with exercise intervention in improving anxiety, depression, sleep quality,
      and mood regulation in Chinese patients with non-small cell lung cancer (NSCLC).The control
      group received conventional psychological nursing care, while the intervention group received
      a combination of MBSR and exercise therapy. Pre- and post-treatment scores of anxiety,
      depression, sleep quality, and the BSRS-5 were compared.
    

Detailed description: 
      To assess the clinical effectiveness of combining Mindfulness-Based Stress Reduction (MBSR)
      with exercise intervention in improving anxiety, depression, sleep quality, and mood
      regulation in Chinese patients with non-small cell lung cancer (NSCLC). A total of 60 lung
      cancer patients from a hospital in Shanxi Province were selected using convenience sampling
      and divided into an intervention group and a control group, with 30 patients in each group.
      The control group received conventional psychological nursing care, while the intervention
      group received a combination of MBSR and exercise therapy. The two group were evaluated by
      the questionnaire three times. One day before the intervention, the first questionnaire was
      conducted, and the basic data of the two groups of patients were collected. The second
      questionnaire evaluation of anxiety, depression, sleep quality, and the Brief Symptom Rating
      Scale (BSRS-5) was conducted 6 weeks after the end of the intervention, and the third
      questionnaire evaluation was conducted 8 weeks after the end of the intervention to evaluate
      the intervention effect of the two groups. Pre- and post-treatment scores of anxiety,
      depression, sleep quality, and the BSRS-5 were compared.
    

Intervention name(s): routine health education; psychological nursing; MBSR therapy; exercise therapy
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): guided the diet of patients, and introduced the knowledge of the disease in detail; hen the patient has negative emotions, patiently listen to the patient's expression, and timely provide language comfort and guidance to the negative psychological emotions; Conducted in small groups once a week for 8 weeks, with each session lasting approximately 1-1.5 hours, encompassed mindfulness-based breathing exercises, dietary interventions, and body scans; Participants were assigned daily tasks for each session, requiring approximately 35-45 minutes per day
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: Lung cancer; Mindfulness-Based Stress Reduction; Exercise intervention; Anxiety; Depression
Is End Tidal CO2 Level Elevation During Upper Endoscopy With CO2 Gas Insufflation Physiologically Significant
Condition: Endoscopy
Study type: Interventional

Summary: 
      During the course of an endoscopic procedure, air has historically been used to inflate the
      lumen to provide adequate visualization and allow for the endoscope to advance as necessary.
      In many adult centers, carbon dioxide is used for insufflation for all procedures. Many
      pediatric centers have started using carbon dioxide for insufflation during endoscopy based
      on the adult studies. Few pediatric studies have been done. This study is designed to test
      whether carbon dioxide is associated with any negative, post-procedural, outcomes in
      pediatric patients.
    

Detailed description: 
      Luminal inflation is essential for adequate visualization and endoscope advancement during
      endoscopy. Although air has previously been the standard gas used, CO2 is increasing
      preferred in adult endoscopy centers, due to reports of decreased post-procedural abdominal
      discomfort compared to air. Few published studies in children demonstrated decreased
      abdominal discomfort with use of CO2, but safety concerns for its use in pediatric endoscopy
      remain.

      This is a Double-blinded, prospective, randomized study of all pediatric patients undergoing
      procedures involving upper endoscopy in the Childrens Hospital & Medical Center.
      Randomization will be for patients undergoing upper endoscopy related procedures. Patients
      will be randomized 1:1 for air or CO2. Vital signs will be recorded before the procedure,
      throughout the procedure and after the procedure until fully awake. While in the procedure
      room, end-tidal CO2 level will be continuously recorded.
    

Intervention name(s): Air; Carbon Dioxide
Intervention type(s): Other; Other
Intervention description(s): Air will be used for luminal inflation.; Carbon dioxide will be used for luminal inflation.
Other intervention name(s): Gas; Gas
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Eligible study participants will be randomized 1:1 into two study arms; one receiving air and the other receiving carbon dioxide for luminal inflation.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: upper endoscopy; endoscope; abdominal discomfort; insufflation; carbon dioxide
Social Adjustment and Quality of Life After Very Preterm Birth
Condition: Low Birth Weight; Premature Birth
MeSH terms: Premature Birth; Birth Weight
Study type: Observational

Summary: 
      The major aim is the follow-up of the highest risk group (< 32 weeks gestation/ < 1500
      birthweight) and their controls of the Bavarian Longitudinal Study (BLS) at the age of 24-27
      years. The focus will be the identification of risk, protective and resiliency factors for
      cognitive and behavioural development and quality of life.

      MRIs of the central nervous system will be conducted to examine aberrant activation patterns
      during the "attention network task" in stratified subgroups. Data driven MRI methods will be
      evaluated in relation to clinical, behavioural and developmental parameters.
    

Detailed description: 
      The major aim is the follow-up of the highest risk group (< 32 weeks gestation/ < 1500
      birthweight) and their controls of the Bavarian Longitudinal Study (BLS) at the age of 24-27
      years. All probands have been assessed previously, neonatally and at additional six time
      points, the last time at the age of 12-13 years. The focus will be the identification of
      risk, protective and resiliency factors for cognitive and behavioural development and quality
      of life. On the basis of previously assessed data statistical modelling of child development
      until age 8.5 years will be conducted across the total range of gestation from 26-42 weeks to
      identify social factors amenable to intervention which could be associated with a positive
      development especially in moderate prematurity. In addition, cross-validation of the findings
      is planned by means of comparisons with three international studies (Millenium Cohort, GB;
      POPS, NL; EPICure, GB). MRIs of the central nervous system will be conducted to examine
      aberrant activation patterns during the "attention network task" in stratified subgroups.
      Data driven MRI methods will be evaluated in relation to clinical, behavioural and
      developmental parameters. In line with the objectives of funding there will be a further
      follow-up of the BLS to answer important questions regarding health and development of very
      small preterms.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Very low birthweight (< 1500g birthweight) and/ or very preterm children (< 32 weeks of
        gestation) and a control group of term born children from the Bavarian Longitudinal Study
      
Biospecimen description: 
      hair
    
Keywords: very low birthweight/ very preterm children; Bavarian Longitudinal Study (BLS); Quality of life and social adjustment in adulthood
Single Dose, Repeated Dose, and Conditional Food Effect Study of PF-05221304 in Healthy Subjects
Condition: Normal Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The current study is the first clinical trial proposed with PF-05221304. It is designed to
      evaluate the safety, tolerability, and pharmacokinetics (PK) following administration of
      single and repeated doses of PF-05221304 to healthy adult subjects. The study may also
      evaluate effect of food on PK of PF-05221304.
    


Intervention name(s): PF-05221304; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Single or repeated, escalating dose of PF-05221304; single or repeated dose of placebo
Allocation: Randomized
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
A Study to Assess the Bioequivalence of Famotidine Chewable Tablets and Film-Coated Tablets (0208-144)
Condition: Heartburn
MeSH terms: Heartburn
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will determine whether the CT formulation of famotidine taken with and without
      water is bioequivalent to the FCT formulation. The primary hypothesis is that the area under
      the concentration-time curve (AUC) and the maximum plasma concentration (Cmax) of a single
      dose of famotidine 20 mg CT without water are equivalent to a single dose of famotidine 20 mg
      FCT with water.
    


Intervention name(s): Famotidine FCT; Famotidine CT
Intervention type(s): Drug; Drug
Intervention description(s): Famotidine 20 mg oral film-coated tablet taken once daily; Famotidine 20 mg oral chewable tablet taken once daily
Intervention MeSH terms: Famotidine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment