bioihbjkbjnl/mcl2 huggingface dataset:
A Study of Chemoradiotherapy Using Gem Plus Nab-paclitaxel for Pancreatic Cancer
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the clinical safety and efficacy of Gemcitabine plus
      nab-Paclitaxel chemoradiotherapy and to determine the Maximal Tolerated Dose (MTD) for
      unresectable locally advanced pancreatic adenocarcinoma.
    

Detailed description: 
      Gemcitabine plus nab-Paclitaxel is one of the standard chemotherapy for metastatic pancreatic
      adenocarcinoma. Gemcitabine plus nab-Paclitaxel realize the favorable anti-tumor effect and
      tolerable toxicity. Gemcitabine plus nab-Paclitaxel is a promising regimen for concurrent
      chemoradiotherapy, but the investigators need to know the safety in the case of the
      concurrent chemoradiotherapy.
    

Intervention name(s): Gemcitabine; Nab-Paclitaxel
Intervention type(s): Drug; Drug
Intervention description(s): Gemcitabine is administered with 30 min intravenous infusion on day 1,8 and 15 every 4 weeks.; Nab-Paclitaxel is administered with 30 min intravenous infusion on day 1,8 and 15 every 4 weeks.
Other intervention name(s): Gemcitabine ；gemzer; Nab-Paclitaxel ；Abraxane
Intervention MeSH terms: Paclitaxel; Albumin-Bound Paclitaxel; Gemcitabine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effect of Spinal Flexion in the Lateral Decubitus Position on the Unilaterality During Spinal Anesthesia
Condition: Spinal Anesthesia
Study type: Interventional

Summary: 
      For unilateral spinal block, spinal local anesthetics should take effect on the spinal nerves
      of one side. With full flexion of the spine, the cauda equina becomes tightened and hangs in
      the middle of the subarachnoid space. This study was performed to assess if flexion of the
      vertebral column facilitates unilateral spinal anesthesia.
    


Intervention name(s): lateral decubitus position with full spinal flexion; lateral decubitus position without spinal flexion
Intervention type(s): Other; Other
Intervention description(s): The patients maintained the lateral decubitus position with the hips and back fully flexed for 15 minutes.; the patients are allowed to straighten their flexed hips and back to obtain the normal lordotic curvature of spinal column
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Blended Learning in Future Physiotherapy Professionals
Condition: Heart Diseases; Teach-Back Communication
MeSH terms: Heart Diseases
Study type: Interventional

Summary: 
      Blended Learning (BL) is proving to be an effective method of teaching within the health
      professions . However, there are still scarce studies on BL conducted with undergraduate
      physiotherapy students. Therefore, the aim of this study was to determine the effectiveness
      of a heart disease BL programme in knowledge, motivation, engagement, design of the programme
      instructions and learning behaviours in physiotherapy students.
    


Intervention name(s): Blended learning in heart disease
Intervention type(s): Other
Intervention description(s): The intervention included face-to-face classes and online resources (Moodle, online syllabus, videos, websites, podcasts, activities, apps, forums, emails, tutoring).
Intervention model: Single Group Assignment
Intervention model description: Students of physiotherapy of the University of Valencia
Masking: None (Open Label)
Primary purpose: Other
Keywords: Blended learning; Education; Teaching methods; Physiotherapy; Students
Clinical Study of the Mirabilis High-Intensity Focused Ultrasound System for Non-Invasive Treatment of Uterine Fibroids
Condition: Uterine Fibroids (Leiomyomas)
MeSH terms: Leiomyoma; Myofibroma
Study type: Interventional

Summary: 
      The Mirabilis High-Intensity Focused Ultrasound (HIFU) Treatment System delivers therapeutic
      focused ultrasound energy to the uterus under integrated ultrasound imaging guidance to offer
      non-invasive treatment for uterine fibroids. The purpose of this clinical study is to assess
      the initial safety and performance of the Mirabilis HIFU Treatment System for transabdominal
      treatment of uterine fibroids in eligible women who are scheduled to undergo hysterectomy
      following treatment with the device or who are seeking relief from fibroid-related symptoms.
    


Intervention name(s): Mirabilis High-Intensity Focused Ultrasound Treatment System
Intervention type(s): Device
Intervention description(s): The intervention consists of a treatment session with the device, during which focused ultrasound energy is applied across the intact abdominal wall to ablate appropriately selected uterine fibroids under ultrasound imaging guidance.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Uterine Fibroids; Leiomyomas; High-Intensity Focused Ultrasound Ablation; Ultrasonography
The Effect of Statins in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 4

Summary: 
      Chronic obstructive pulmonary disease (COPD) is a condition of the lungs which results in
      breathing difficulties due to the lungs becoming inflamed and the airways narrowed. Current
      treatments have focused on opening up the narrowed airways but, in addition, we know there is
      increased inflammation in the blood and these patients are at increased risk of heart
      disease. Statins, simvastatin being one of them, are drugs used to lower cholesterol in the
      blood but may also reduce inflammation and lower the risk of heart disease. This study will
      explore whether simvastatin reduces one of the risk factors in patients with COPD in a short
      term proof of principle study. The key purpose is to determine whether simvastatin improves
      the pressure and stiffness of the main blood vessels namely the arterial stiffness measure of
      aortic pulse wave velocity (PWV). In parallel, we will describe changes in airways and / or
      blood inflammation and change in breathing ability
    


Intervention name(s): Simvastatin; Lactose tablet
Intervention type(s): Drug; Drug
Intervention description(s): Simvastatin 20mg once daily (in the evening) for 6 weeks; One tablet taken each evening for 6 weeks
Intervention MeSH terms: Simvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Phase 2 Study of Safety, Tolerability, and Immunogenicity of Three Dose Levels of ACAM3000 Smallpox Vaccine
Condition: Smallpox
MeSH terms: Smallpox
Study type: Interventional
Phase: Phase 2

Summary: 
      A phase 2 study to assess the MVA smallpox vaccine in previously vaccinated and vaccine-
      naive subjects at three dose levels.
    

Detailed description: 
      This study will be a randomized, double-blind, placebo-controlled out-patient study conducted
      in multiple centers in the United States (US). Up to 700 healthy male and female adult
      subjects 18 to 55 years of age (inclusive), who have been previously vaccinated or subjects
      who are naïve to smallpox vaccine will be enrolled. Subjects will be randomized to 1 of 8
      treatment groups with 100 (or 50 placebo) subjects per group in which they will receive
      either ACAM3000 MVA Smallpox Vaccine (1 of 3 dose levels) or placebo on Study Days 0 and 28.
      All personnel associated with the trial will be blinded as to treatment, with the exception
      of the study pharmacist who prepares the treatment for administration to each subject. There
      are 2 control groups in this study. A comparison of adverse events and other safety
      assessments between placebo and ACAM3000 MVA Smallpox Vaccine will be performed. In addition
      to serving as a control for safety, the previously vaccinated subjects receiving placebo will
      serve as a control for antibody and T-cell responses in persons with preexisting immunity who
      receive ACAM3000 MVA Smallpox Vaccine. Safety, tolerability, and immunogenicity data for 110
      subjects undergoing primary immunization with graded doses of ACAM3000 MVA Smallpox Vaccine
      will be available following completion of Acambis protocol H-249-001, an ongoing phase I
      clinical trial. The doses levels in this study may be changed following the availability of
      results from protocol H-249-001. Statistical analysis will focus on comparisons among the
      dose levels of ACAM3000 MVA Smallpox Vaccine and comparisons of ACAM3000 MVA Smallpox Vaccine
      to placebo, as appropriate. A separate analysis will be performed for previously vaccinated
      and naïve subjects. Descriptive statistics will be used to compare demographic and baseline
      clinical data between stratum.
    

Intervention name(s): MVA Smallpox vaccine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Two 0.5mL subcutaneous injections, separated by 28 days; Two 0.5mL subcutaneous injections, separated by 28 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: MVA Vaccine
A Phase 3b, Open-Label, Safety and Efficacy Study of Rotigotine as Add-On Therapy With Low Doses of Pramipexole or Ropinirole in Patients With Advanced Parkinson's Disease
Condition: Advanced Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is to investigate the safety and efficacy of Rotigotine add-on therapy with low
      doses of Pramipexole or Ropinirole in patients with advanced-stage Parkinson's Disease (PD)
      who have insufficient response to L-dopa and low doses dopamine receptor agonists.
    


Intervention name(s): Rotigotine
Intervention type(s): Drug
Intervention description(s): Application of Rotigotine up to 8 mg/24 h patches for 24 hours.
Other intervention name(s): Neupro
Intervention MeSH terms: Rotigotine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Rotigotine; Neupro
Analgesic Properties of Oral Sucrose During Immunizations
Condition: Procedural Pain
MeSH terms: Pain, Procedural
Study type: Interventional

Summary: 
      The purpose of this study is to examine the analgesic properties of oral sucrose during
      routine immunizations. Hypothesis: Oral sucrose solution and maternal contact will
      significantly decrease the objective measures of acute pain during routine immunizations.
    

Detailed description: 
      The purpose of this study is to examine the analgesic properties of oral sucrose during
      routine immunizations. Hypothesis: Oral sucrose solution and maternal contact will
      significantly decrease the objective measures of acute pain during routine immunizations.

      Acute pain during early life may alter infant pain responses, cognitive development and
      behavioral outcomes. Infants respond to immunizations with significant pain and distress.
      This study will examine the analgesic properties of oral sucrose and maternal holding in
      postnatal infants.

      Comparison: Administration of oral sucrose, sterile water and maternal contact 2 minutes
      before routine immunizations.
    

Intervention name(s): Administration of oral Sucrose; Administration of oral Placebo
Intervention type(s): Other; Other
Intervention description(s): Participants received oral sucrose 2 minutes prior to the combind DTaP, IPV, and Hep B vaccine.; Participants received Placebo 2 minutes prior to the combind DTaP, IPV, and Hep B vaccine.
Other intervention name(s): sterile water
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Pain; Procedural pain; Sucrose; Infant
Vasopressin Deficiency in Hemorrhagic Shock
Condition: Body Response to Trauma
MeSH terms: Diabetes Insipidus, Neurogenic; Shock, Hemorrhagic
Study type: Observational

Summary: 
      In this study we hope to delineate the typical vasoactive mediator response of trauma
      patients to shock. We plan to assess serum levels of vasopressin and also catecholamines,
      angiotensin, and cortisol during resuscitation of trauma patients to delineate high risk
      populations for vasopressin deficiency.
    

Detailed description: 
      This is a prospective observational study. The only research-driven procedure will be the
      removal of blood samples at designated time points(total blood removed 48 cc per patient).
      Hemodynamic, fluid infusion and agitation/pain data (RAMSEY Score) will prospectively be
      collected for research purposes. We will collect data from a convenience sample of patients
      (when research staff is available) over a one year period.
    

Intervention name(s): Phlebotomy
Intervention type(s): Other
Intervention description(s): Blood draws (total 48 cc blood)
Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        observational study - trauma patients admitted to University Hospital
A Study to Evaluate the Efficacy and Safety of Daratumumab in Pediatric and Young Adult Participants Greater Than or Equal to (>=)1 and Less Than or Equal to (<=) 30 Years of Age With Relapsed/Refractory Precursor B-cell or T-cell Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma
Condition: Precursor Cell Lymphoblastic Leukemia-Lymphoma
MeSH terms: Lymphoma; Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid; Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy of daratumumab in addition to standard
      chemotherapy in pediatric participants with relapsed/refractory B-cell acute lymphoblastic
      leukemia (ALL)/lymphoblastic lymphoma (LL) and T-cell ALL/LL as measured by the complete
      response (CR) rate.
    

Detailed description: 
      Screening for eligible participants will be performed within 21 days before administration of
      the study drug. Participants with B-cell ALL/LL will receive treatment until disease
      progression, unacceptable toxicity or achievement of CR followed by hematopoietic stem cell
      transplant (HSCT). Participants with T cell ALL/LL will receive treatment for up to 2 cycles.
      If disease progression is confirmed, then the participant will discontinue study treatment,
      complete the End of Treatment Visit, and enter the Posttreatment Period. For those
      participants who discontinue study drug prior to disease progression, disease evaluations
      will continue to be performed every 8 weeks until subsequent anticancer therapy is initiated.
    

Intervention name(s): Daratumumab; Vincristine; Prednisone; Doxorubicin; Peg-asparaginase; Cyclophosphamide; Cytarabine; 6-mercaptopurine; Methotrexate
Intervention type(s): Drug; Drug; Drug; Drug; Biological; Drug; Drug; Drug; Drug
Intervention description(s): Participant will receive daratumumab 16 milligram per kilogram (mg/kg) in cohort 1 and cohort 2.; Participant will receive vincristine 1.5 milligram per meter square (mg/m^2) in cohort 1 and cohort 2.; Participant will receive prednisone 40 mg/m^2 in cohort 1 and cohort 2.; Participant will receive doxorubicin 60 mg/m^2 in cohort 2.; Participant will receive peg-asparaginase 2500 units per meter square (U/m^2) in cohort 2.; Participant will receive cyclophosphamide 1 gram per meter square (g/m^2) once in cohort 2.; Participant will receive cytarabine 75 mg/m^2 in cohort 2.; Participant will receive 6-mercaptopurine 60 mg/m^2 orally daily in cohort 2.; Participant will receive methotrexate 5 g/m^2 intravenously (IV) in cohort 2.
Intervention MeSH terms: Cytarabine; Prednisone; Cyclophosphamide; Doxorubicin; Methotrexate; Vincristine; Asparaginase; Daratumumab; Mercaptopurine; Pegaspargase
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Adaptive Optics ScanningLaser Ophthalmoscope Safety and Efficacy Clinical Trial
Condition: Retinal Disease; Healthy
MeSH terms: Retinal Diseases
Study type: Observational

Summary: 
      This prospective, multicenter, single-group, target-value clinical trial was designed to
      evaluate the efficacy and safety of an Adaptive Optics ScanningLaser Ophthalmoscope(AOSLO)
      for ophthalmic examination.
    

Detailed description: 
      objective: This study aims to collect AOSLO retinal images from human population to assess
      the imaging quality and quantitative measurement consistency of AOSLO devices manufactured by
      Robotrak and also monitor any possible side effects.

      study population: randomly invited 194 volunteers who meets inclusion criteria

      design: the study is an observational protocol that participants will be imaged with Robotrak
      AOSLO systems to get cellular level images of photoreceptors and blood vessels in foveal
      area. Automatics analysis of cell/blood vessel morphology parameters will be calculated for
      consistency evaluation. In general, participants will undergo a complete ophthalmic
      examination including assessments of visual acuity, intraocular pressure, slit lamp
      examination, ocular biometry, OCT, fundus imaging, multi-focal ERG and OCT scan to assess
      potential side effects of AOSLO imaging.

      outcome measures: the primary efficacy outcome measure of this study are multi expert grading
      of the image quality collected.

      the secondary efficacy outcome measure are quantitative assessment of the morphological
      parameters generated from the captured images and device operator ratings.

      the safety measures are side effect signs from ophthalmic examinations before&after AOSLO
      imaging
    

Intervention name(s): No intervention measures
Intervention type(s): Other
Intervention description(s): No intervention measures
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        randomly invited volunteers from primary eyecare outpatient patients or accompanying family
        members who meet the inclusion criteria
      
Keywords: healthy patients; eye disease
Vitamin D Oral Replacement in Asthma
Condition: Asthma; Vitamin D Deficiency; Pediatric Obesity
MeSH terms: Asthma; Vitamin D Deficiency; Pediatric Obesity
Study type: Interventional

Summary: 
      The overall objective of the study is to determine the pharmacokinetics of Vitamin D
      supplementation in children who have asthma and are overweight or obese.
    

Detailed description: 
      This study has two parts. In part 1, study participants will be randomized to receive one of
      four doses of vitamin D supplementation in international units (IU) over at 16-week period:
      1) Single 50,000 IU loading dose + 6000 IU daily dose; 2) Single 50,000 IU loading dose +
      10,000 IU daily dose: 3) 6000 IU daily dose; or 4) 600 IU daily dose. Based on
      pharmacokinetic analysis, one of the doses (1-3) will be selected to use in part 2.

      In part 2, study participants will be randomized to the dose selected in part 1 or the 600 IU
      daily dose of vitamin D supplementation to be administered over a 16-week dosing period.

      Across both parts, safety of each dose regimen of vitamin D supplementation will be
      evaluated, and the effectiveness of each dose to achieve a serum level of 25(OH)D greater
      than or equal to 40 ng/ml will be assessed.
    

Intervention name(s): Vitamin D3 oral regimen
Intervention type(s): Dietary Supplement
Intervention description(s): Vitamin D3 oral regimens supplementation
Intervention MeSH terms: Vitamin D; Cholecalciferol
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, parallel arm clinical trial 4 arms in part 1 2 arms in part 2
Masking: None (Open Label)
Primary purpose: Other
Keywords: pediatric obesity
Effectiveness of Injury Prevention Guidelines in Recreational Runners
Condition: Sports Injury
MeSH terms: Wounds and Injuries; Athletic Injuries
Study type: Interventional

Summary: 
      The aim of this trial is to investigate the effectiveness of specific training programs on
      the incidence of injuries in recreational runners. 408 runners between the ages of 18 and 55
      years, will be recruited and randomly allocated to either the intervention group or control
      group. The intervention group will perform the training program twice a week in addition to
      their regular training. Injury data will be collected as the injuries occur and documentation
      of injury will follow a predetermined definition of injury. Participants will submit weekly
      reports of their running distance, frequency, running-related pain, as well as successful
      performance of the assigned training program for the intervention groups. The primary outcome
      is the incidence of injuries in all groups.
    

Detailed description: 
      Injuries and especially overuse injuries within recreational running are a common occurrence
      with higher incidence rates in novice runners but also in recreational runners training for a
      specific event. The mechanisms behind overuse injury development are thought to be
      multifactorial and certain parameters have shown to increase injury risk in recreational
      runners. The aim of this trial is to target these specific parameters and implement training
      programs to which recreational runners will adhere for a period of 18 weeks. About 408 male
      and female recreational runners, aged 18-55 years will be randomly allocated to one either
      the intervention (INT) or Control (CON).The INT group will perform an exercise program
      containing muscle control and foamrolling exercises in addition to their regular training,
      twice a week. The CON group will continue as per usual with their training. Training data
      will be collected on a weekly basis from all groups and pain and injury information will be
      submitted by the participants upon occurrence. The primary outcome measure is the number of
      sustained injuries in both groups. Participants will be recruited in December 2018 and the
      intervention will start in January 2019 for a period of 18 weeks, ending in May 2019. Data
      analyses are anticipated to be completed in September 2019.
    

Intervention name(s): Exercise program
Intervention type(s): Other
Intervention description(s): The runners will be asked to perform the training program twice a week. The intervention consist of muscle control and foam rolling exercises for the lower extremities.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Running-related injury