bioihbjkbjnl/mcl2 huggingface dataset:
Single Ascending Dose Study of Safety and Tolerability of Sarilumab and Methotrexate in Japanese Patients With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary Objective:

      To assess the safety and tolerability of a single dose of subcutaneously administered
      sarilumab in Japanese patients with rheumatoid arthritis (RA) who are receiving concomitant
      treatment with methotrexate.

      Secondary Objective:

      To assess the pharmacokinetic profile of a single subcutaneous (SC) dose of sarilumab in
      Japanese RA patients.
    

Detailed description: 
      Total study duration per patient is up to 88 days

        1. Screening: 3 to 28 days

        2. Treatment: 1 day

        3. Follow-up: 57± 3 days after dosing
    

Intervention name(s): sarilumab SAR153191 (REGN88); placebo; methotrexate; folic acid
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Pharmaceutical form:solution Route of administration: subcutaneous; Pharmaceutical form:solution Route of administration: subcutaneous; Pharmaceutical form:capsule Route of administration: oral; Pharmaceutical form:tablet Route of administration: oral
Intervention MeSH terms: Folic Acid; Methotrexate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Comparison of Individual Culture and Group Culture of Preimplantation Embryos in Human IVF Treatments
Condition: Other Complications Associated With Artificial Fertilization
Study type: Observational

Summary: 
      Prospective randomized comparison of two widely used in vitro culture system in human IVF
      treatments. In vitro fertilized oocytes and embryos are cultured in individual culture media
      droplets using conventional petridish or in group culture using WOW (well of the well)
      petridish.

      Primary outcome: implantation and pregnancy rates Secondary outcome: fertilization rate and
      embryo quality
    


Intervention name(s): individual embryo culture or group culture
Intervention type(s): Other
Intervention description(s): Embryos cultured in a 25 microliter droplet of culture media individually in a conventional petridish or in groups of 2-10 embryos in a Well-of-the-Well petridish
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients entering in vitro fertilization and embryo transfer treatment
      
Keywords: In vitro fertilization; Embryo transfer; Embryo culture; individual culture; Group culture; embryo quality; Pregnancy rate; Implantation
Cardiovascular Risk Factors, Body Composition, Fitness Levels And Quality Of Life In Overweight And Obese 8-17 Year Olds
Condition: Childhood Obesity; Type 2 Diabetes; Hypercholesterolemia; Hypertension
MeSH terms: Overweight; Hypercholesterolemia; Pediatric Obesity
Study type: Interventional

Summary: 
      This project will address the important area of childhood obesity and the risk of
      cardiovascular disease associated with obesity. This is a serious health concern since
      children who are overweight or obese are prone to other medical conditions including high
      blood pressure, abnormal lipid profiles,and type 2 diabetes. Although exercise and nutrition
      programs are recommended, evidence for the efficacy of these programs in improving
      cardiovascular health is lacking.

      Specific Aims: a) improve cardiovascular risk factors, b) increase physical fitness levels,
      c) improve lean body mass, d) enhance QOL of the child e) influence adherence rates to
      exercise and a healthy lifestyle change both during and beyond the conclusion of the program.

      Hypothesis 1a: Compared to baseline and matched controls, children randomized to a 10 week
      multidisciplinary fitness and nutrition program will show significant improved levels of
      cardiovascular risk factors.

      Specific Aim 2: To determine if a multidisciplinary fitness and nutrition program, when
      compared with a matched, WLC group will show a change in whole body assessment including a
      decrease in fat mass, an increase in percent lean body mass, and a decrease in percent body
      fat, as measured utilizing dual-energy X-ray absorptiometry Hypothesis 2a: Compared to
      baseline and matched controls, children randomized to a 10 week multidisciplinary fitness and
      nutrition program will show improved whole body assessments including.

      Specific Aim 3:To determine if a multidisciplinary fitness and nutrition program, when
      compared with a WLC group will show improved levels of fitness. Hypothesis 3a: Compared to
      baseline and matched controls, children randomized to a 10 week multidisciplinary fitness and
      nutrition program will show significant improvements in fitness including.
    


Intervention name(s): Exercise
Intervention type(s): Other
Intervention description(s): Strength training, aerobic exercise and core strengthening, running
Intervention model: Single Group Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pediatric Overweight/Obesity, DEXA, Fitness
Posterior Parasagittal In-Plane Ultrasound-Guided Infraclavicular Brachial Plexus Block
Condition: Brachial Plexus Block
Study type: Interventional

Summary: 
      Abstract

      Introduction: The brachial plexus at the infraclavicular level runs deeper compared to its
      course proximally, giving rise to impaired needle visualisation due to the steep angle of
      needle insertion with the current ultrasound-guided approach. A new posterior parasagittal
      in-plane ultrasound-guided infraclavicular approach was introduced to improve needle
      visibility. However no further follow up study was done.

      Methods: We performed a case series and a cadaveric dissection to assess its feasibility in a
      single centre, University of Malaya Medical Centre, Kuala Lumpur, Malaysia from November 2012
      to October 2013. After obtaining approval from the Medical Ethics Committee, University
      Malaya Medical Centre, 18 patients undergoing upper limb surgery were prospectively
      recruited. A cadaveric dissection was also performed. The endpoints of this study were the
      success rate, performance time, total anaesthesia related time, quality of anaesthesia and
      any incidence of complications.
    

Detailed description: 
      Introduction Our study focus on the ultrasound guided infraclavicular brachial plexus block,
      which is a cord-level block of the brachial plexus for surgical procedures below mid-humerus.
      The brachial plexus at this level runs deeper compared to its course proximally, giving rise
      to impaired needle visualisation due to the steep angle of needle insertion with the current
      ultrasound-guided approach (lateral para-sagittal in-plane technique).1

      A new ultrasound-guided posterior approach parasagittal in-plane infraclavicular block was
      introduced to improve needle visibility.2 However no further follow up study was done.

      Therefore, we performed a case series of 18 patients with a cadaveric dissection, to assess
      the feasibility of this approach.

      Methods After obtaining ethics committee approval from the Medical Ethics Committee,
      University Malaya Medical Center, Kuala Lumpur, Malaysia (Chairperson Professor Dr. Looi Lai
      Meng; IRB reference no. 949.14 dated 17 October 2012, amendment no.1038.76 dated 19 December
      2013) and written informed consent, 18 patients undergoing surgery of the elbow, forearm,
      wrist, or hand were prospectively recruited based on the criteria below.
    

Intervention name(s): Posterior approach
Intervention type(s): Procedure
Intervention description(s): We adopted the technique as described by Hebbard et al.
Other intervention name(s): posterior approach parasagittal in-plane
Intervention model: Single Group Assignment
Masking: None (Open Label)
Physical Therapy Treatments, Including Neural Mobilization and Hip/Back Stretches for People Between 50-89 With Lumbar Spinal Stenosis and Leg Pain Provoked by Walking
Condition: Lumbar Spinal Stenosis
MeSH terms: Spinal Stenosis; Constriction, Pathologic
Study type: Interventional

Summary: 
      Aging of the back is common in the older people and can result in difficulties standing and
      walking. Conservative treatment is recommended before considering surgery. Some recommended
      exercises involve the use of expensive equipment. The present study plans to evaluate if
      specifically moving the nerves in the legs/back and improving flexibility of the hip and back
      can benefit patients. These exercises require no equipment, are simple to perform, and can
      provide patients a way to continue to perform these exercises at home. The purposes of this
      study are to (1) observe the benefit of a treatment program involving moving the nerves of
      the leg/back, stretching the legs and low back in patients with low back pain and
      difficulties walking; and (2) determine if benefits received remain at a 3-month follow-up.
    


Intervention name(s): Physical therapy intervention
Intervention type(s): Other
Intervention description(s): Double knee to chest stretches, hip extension mobilization, neural mobilizations, home exercises program
Intervention model: Single Group Assignment
Intervention model description: Case Series
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Degenerative lumbar spinal stenosis; Neural mobilization; Hip extension mobilization; Case series; Neurogenic claudication
The Effects of Ectoin® Allergy Nasal Spray and Ectoin® Allergy Eye Drops Compared to Placebo
Condition: Allergic Rhinitis; Allergic Conjunctivitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Conjunctivitis; Conjunctivitis, Allergic; Hypersensitivity
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to assess the relative efficacy of Ectoin® Allergy Eye
      Drops and Ectoine® Allergy Nasal Spray compared to placebo, by evaluating Total Nasal Symptom
      Score (TNSS) and Total Ocular Symptom Score (TOSS).

      The secondary objectives are :

        -  To evaluate the relative efficacy of Ectoin® Allergy Eye Drops and Ectoin® Allergy Nasal
           Spray compared to placebo by evaluating Total Non Nasal Symptom Score (TNNSS),
           congestion symptom scores, red eye symptom scores, watery eye symptom scores, itchy eye
           symptom scores, and by evaluating the mean cross-sectional area (MCA) using acoustic
           rhinometry (AcR).

        -  To assess the change from baseline (post-EEC from pre-EEC) in inflammatory parameters of
           nasal secretions, comparing Ectoin® Allergy Eye Drops and Ectoin® Allergy Nasal Spray to
           placebo at each post-treatment visit.
    


Intervention name(s): Ectoin® Allergy Nasal Spray and Ectoin® Allergy Eye Drops; Placebo
Intervention type(s): Device; Device
Intervention description(s): Placebo Eye Drops/Nasal Spray
Intervention MeSH terms: Ophthalmic Solutions
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Allergic Rhinitis; Conjunctivitis; Bitop; Eye; Eye Drops; Nasal Spray; Total Nasal Symptom Score; Total Ocular Symptom Score; AUC
Evaluation of Pharmacokinetic Interaction of Indacaterol With Ketoconazole in Healthy Adult Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the interaction potential between indacaterol and ketoconazole (a
      potent CYP3A inhibitor) in healthy adult subjects.
    


Intervention name(s): Indacaterol (QAB149)
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pharmacokinetics, interaction, QAB149, indacaterol, ketoconazole, healthy subjects
Ezetimibe Plus Simvastatin Versus Simvastatin in Untreated Subjects With High Cholesterol (P03435)
Condition: Hypercholesterolaemia; Atherosclerosis
MeSH terms: Atherosclerosis; Hypercholesterolemia
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will assess whether co-administration of ezetimibe 10 mg with simvastatin 20 mg
      will be more effective than treatment with simvastatin 20 mg alone in reducing LDL-C
      concentrations when administered for 6 weeks.
    


Intervention name(s): Ezetimibe + Simvastatin; Simvastatin
Intervention type(s): Drug; Drug
Intervention description(s): oral tablets: ezetimibe 10 mg + simvastatin 20 mg once daily for 6 weeks; oral tablets: simvastatin 20 mg + ezetimibe placebo once daily for 6 weeks
Other intervention name(s): SCH 58235; Zetia; Zocor; Zocor
Intervention MeSH terms: Simvastatin; Ezetimibe
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Levosimendan Versus Combination With Magnesium Sulphate on Spine Protection by NIRS in Infants Undergoing Coarctectomy
Condition: Aortic Coarctation
MeSH terms: Aortic Coarctation
Study type: Interventional
Phase: Phase 4

Summary: 
      In pediatric patients ,undergoing elective surgical correction of aortic coarcatation one of
      our main concern is spinal cord protection .Our aim to study the protective effect of
      levosimendan versus its combination with magnesium sulphate .
    

Detailed description: 
      Effect of levosimendan and its combination with magnesium sulphate infusion as spinal cord
      protection using NIRS values before Aortic cross clamp and 10,20 min after cross clamp till
      the end of surgery .
    

Intervention name(s): Saline Solution; Levosimendan; Magnesium Sulfate
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Placebo; Levosimendan; Magnesium Sulfate
Other intervention name(s): Nacl 0.9 %
Intervention MeSH terms: Magnesium Sulfate; Simendan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Yoga/Pranayama for Posttraumatic Stress Disorder
Condition: Posttraumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional

Summary: 
      This study aims to investigate the effect of a pranayama focused yoga intervention on
      post-traumatic symptom severity in patients with post-traumatic stress disorder undergoing
      standard psychotherapy/ trauma-focused cognitive-behavioral therapy (TF-CBT). Therefore,
      short pranayama sessions of 5-10 minutes will be provided to the patients directly at the
      begin of each of standard TF-CBT unit, while the control group will get standard TF-CBT
      alone. It should further be investigated, whether pranayama can enhance the affective
      tolerance of patients with post-traumatic stress disorder towards the used exposure
      techniques of TF-CBT.
    


Intervention name(s): Pranayama assisted trauma-focused Cognitive Behavioral Therapy (TF-CBT); Trauma-focused Cognitive Behavioral Therapy (TF-CBT)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The pranayama intervention is placed directly at the begin of the respective TF-CBT unit and will be repeated for 10 subsequent TF-CBT units. Pranayama contains the performance of Kapalabhati, Ujjayi, and/or Nadi Shodhana (for overall 1 minute) as well as following Kumbhaka (intentional respiratory reflex inhibition). Pranayama will be repeated 3 times before each TF-CBT unit.; Trauma-focused Cognitive Behavioral Therapy (TF-CBT)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Posttraumatic Stress Disorder; Cognitive-Behavioral Therapy; Complementary Therapies; Yoga; Pranayama; Effectiveness; Safety; Randomized Controlled Trial
Primary Vaccination Study With a Pneumococcal Conjugate Vaccine in Healthy Children 6 to 10 Weeks of Age
Condition: Infections, Streptococcal; Streptococcus Pneumoniae
MeSH terms: Pneumonia, Pneumococcal; Streptococcal Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess the immunogenicity in terms of antibody response and
      the safety/reactogenicity in terms of solicited and unsolicited symptoms and serious adverse
      events following primary vaccination of Indian infants with pneumococcal conjugate vaccine
      GSK1024850A co-administered with a diphtheria, tetanus, whole cell pertussis (DTPw)-combined
      vaccine during the first 4 months of life. The study will be conducted in India.
    


Intervention name(s): Pneumococcal conjugate vaccine GSK1024850A; Tritanrix-HepB/Hib; Hiberix; Tritanrix-HepB
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): Intramuscular injection, 3 doses; Intramuscular injection, 3 doses; Intramuscular injection, 3 doses; Intramuscular injection, 3 doses
Other intervention name(s): DTPw-HBV/Hib; Hib; DTPw-HBV
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Pneumococcal disease; Pneumococcal vaccine; Safety; Primary vaccination; Immunogenicity
Neoadjuvant Chemoradiation in Patients With Borderline Resectable Pancreatic Cancer
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Previous reports suggest benefit of neoadjuvant chemoradiation treatment for borderline
      resectable pancreas cancer. This study is a multicenter prospective randomized phase II/III
      study of neoadjuvant chemoradiation with gemcitabine in patients with borderline resectable
      pancreas cancer. The study is designed in 2 arms, one with upfront surgery and the other with
      neoadjuvant chemoradiation therapy.
    

Detailed description: 
      Previous reports suggest benefit of neoadjuvant chemoradiation treatment for borderline
      resectable pancreas cancer.

      This study is a multicenter prospective randomized phase II/III study of neoadjuvant
      chemoradiation with gemcitabine in patients with borderline resectable pancreas cancer. The
      study is designed in 2 arms, one with upfront surgery and the other with neoadjuvant
      chemoradiation therapy.

      This phase 2/3 multicenter randomized controlled trial was designed to enroll 110 patients
      with BRPC who were randomly assigned to gemcitabine-based neoadjuvant chemoradiation
      treatment (54 Gray external beam radiation) followed by surgery or upfront surgery followed
      by chemoradiation treatment from four large-volume centers in Korea. The primary endpoint was
      the 2-year survival rate (2-YSR). Interim analysis was planned at the time of 50% case
      enrollment.
    

Intervention name(s): Neoadjuvant chemoradiation; Upfront surgery
Intervention type(s): Drug; Procedure
Intervention description(s): Neoadjuvant chemoradiation; 45Gy/25fx + 9Gy/5fx of radiation over 6 weeks with Gemcitabine 400mg/㎡
4 weeks rest, re-evaluation for resectability
operation
start maintenance chemotherapy within 4~6 weeks after operation with Gemcitabine 1000mg/㎡ (D1, 8, 15) every 4 weeks, for 4 cycle; Operation at time of diagnosis
Adjuvant chemoradiation; 45Gy/25fx + 9Gy/5fx of radiation over 6 weeks with Gemcitabine 400mg/㎡
start maintenance chemotherapy within 4~6 weeks after completion of adjuvant chemoradiation with Gemcitabine 1000mg/㎡ (D1, 8, 15) every 4 weeks, for 4 cycle
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pancreas; cancer; borderline resectable; locally advanced; resectability; chemotherapy; radiation; chemoradiation; neoadjuvant; survival; prognosis; recurrence; response rate
Safety, Tolerability and Efficacy of Evolocumab (AMG 145) in Children With Inherited Elevated Low-density Lipoprotein Cholesterol (Familial Hypercholesterolemia)
Condition: Familial Hypercholesterolemia
MeSH terms: Hyperlipoproteinemia Type II; Homozygous Familial Hypercholesterolemia; Hypercholesterolemia
Study type: Interventional
Phase: Phase 3

Summary: 
      The main purpose of this study is to describe the safety and tolerability of 80 weeks of
      subcutaneous (SC) evolocumab when added to standard of care in children 10 to 17 years of age
      with familial hypercholesterolemia.
    


Intervention name(s): Evolocumab
Intervention type(s): Biological
Intervention description(s): Administered by subcutaneous injection
Other intervention name(s): Repatha®; AMG 145
Intervention MeSH terms: Evolocumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hypercholesterolemia; Elevated Cholesterol; High Cholesterol; PCSK9 mutations; Severe Familial Hypercholesterolemia; evolocumab; Repatha; Heterozygous Familial Hypercholesterolemia; Homozygous Familial Hypercholesterolemia; Pediatric; Paediatric
The Value of Preoperative Diagnosis and Prognostic Prediction Based on Radiomics of Giant Cell Tumor of Spine
Condition: Spinal Tumor
MeSH terms: Giant Cell Tumors; Spinal Cord Neoplasms; Spinal Neoplasms
Study type: Observational

Summary: 
      1. Exploit CT (plain scan), enhanced CT and fMRI based radiomic biomarkers, explore their
           correlation with the prognostic molecular markers of spinal GCTB(p53/vegf/rank/rankl…),
           and help accurate diagnosis of GCTB.

        2. Exploring a new method of preoperative risk stratification for spinal GCTB, and
           establishing radiomic model combined with clinical features. Exploring the GCTB
           biological behavior prediction model and the prognosis prediction of GCTB.
    

Detailed description: 
      This study intends to conduct a systematic review of patients with spinal GCTB who have
      undergone standardized imaging (CT or MRI) in our hospital since 2006 to obtain case samples,
      conduct standardized clinical and imaging data extraction and analysis, and fully integrate
      histopathology and clinical follow-up results. To preliminarily explore the value of
      postoperative imaging-based radiomics markers in the preoperative precise diagnosis of spinal
      GCTB, risk stratification and prediction of tumor biological behavior.
    

Intervention name(s): RANK/RANKL(RANK: Receptor Activator of Nuclear factor Kappa-Β /RANKL:Receptor Activator of Nuclear factor Kappa-Β Ligand)
Intervention type(s): Diagnostic Test
Intervention description(s): Immunohistochemical staining was performed using the following antibodies: anti-RANK antibody from Bioss Company (No.bs-2695R) and anti-RANKL antibody from Abcam (No.ab222215).
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients diagnosed with spinal GCTB
      
Keywords: giant cell tumor of bone; radiomics; recurrence; spine tumor