bioihbjkbjnl/mcl2 huggingface dataset:
Study on the Efficacy and Safety of PEG-rhG-CSF in Preventing Neutropenia During Concurrent Chemoradiotherapy of Cervical Cancer
Condition: Cervical Cancer
MeSH terms: Uterine Cervical Neoplasms; Neutropenia
Study type: Interventional
Phase: Phase 2

Summary: 
      This randomized controlled prospective study aims to explore the efficacy and safety of using
      (PEGylated Recombinant Human Granulocyte Stimulating Factor) PEG-rhG-CSF to prevent
      neutropenia during concurrent chemoradiotherapy of paclitaxel and cisplatin (TP) regimen for
      cervical cancer. To find out the best time to use PEG-rhG CSF, and to explore investigate the
      effect of PEG-rhG-CSF on long-term bone marrow function in the process of concurrent
      chemoradiotherapy, and finally to explore the clinical feasibility of using PEG-rhG-CSF to
      prevent neutropenia during concurrent chemoradiotherapy of TP regimen for cervical cancer.
    

Detailed description: 
      Study design: In this prospective, single-center, randomized controlled study, patients with
      locally advanced cervical cancer are randomly divided into two groups. Patients in the
      experimental group will receive PEG-rhG-CSF 6mg prevention during concurrent
      chemoradiotherapy, whereas the control group do not use PEG-rhG-CSF for prevention. When the
      patient's ANC is less than 1✕109/L, 5μg/kg rhG-CSF will be given for treatment until the ANC
      returned to 2✕109/L.

      Case selection: patients with IIb-IIIb cervical cancer, squamous cell carcinoma confirmed by
      histopathology, and three-week regimen of paclitaxel and carboplatin with Concurrent
      Radiotherapy.

      Primary end point: incidence and duration of grade 3/4 neutropenia in patients. Secondary
      endpoints: 1) Incidence of febrile neutropenia (FN); 2) the rate of postponement of the
      course of radiotherapy, reduction in chemotherapy dose and postponement of the course of
      chemotherapy; 3) Changes of bone marrow function in patients 3 months and 6 months after
      radiotherapy.

      Safety assessment: laboratory safety testing, including platelet count and hemoglobin.
      Evaluation of adverse events: infection, neutropenic fever, bone pain, etc.
    

Intervention name(s): PEG-rhG-CSF; rhG-CSF
Intervention type(s): Drug; Drug
Intervention description(s): During the concurrent chemoradiotherapy, a single subcutaneous injection of 6 mg PEG-rhG-CSF was given to the patient 2 hours after radiotherapy on the first day after the end of chemotherapy. Blood tests were performed weekly, if the patient's neutrophils were less than 1.0 × 109 / L during radiotherapy, rhG-CSF was given as a remedial treatment. If fever occurs, antibiotics were given promptly.; Blood tests were performed weekly, if the patient's neutrophils were less than 1.0 × 109 / L during radiotherapy, rhG-CSF was given as a remedial treatment. If fever occurs, antibiotics were given promptly.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Cervical Cancer; concurrent chemoradiotherapy; neutropenia; PEG-rhG-CSF
Prevalence, Etiology and Therapy of Micturition Disorders of Children With a Mental and/or Motoric Disability
Condition: Micturition Disorder
MeSH terms: Urination Disorders
Study type: Interventional

Summary: 
      Investigation of the prevalence etiology and therapy of micturition disorders of children
      with a mental and/or motoric disability
    

Detailed description: 
      Overview of the problem by a questionnaire, diary of micturition and drinking behaviour,
      filled out by the parents or by the staff of the institution.

      Investigation of the etiology by clinical and functional examination (uroflowmetry, bladder
      scan, video-urodynamic examination).

      Frequency:

        -  Uroflowmetry: two periods of two weeks, with 6 weeks break between both periods. During
           the follow-up period every 3 months during 12 months

        -  Bladder scan: once during the periods of the uroflowmetry

        -  Video-urodynamic examination: once in selected participants, after consent of the
           parents

        -  Adaptation of the drinking behaviour: start after two weeks of observation, after
           uroflowmetry and bladder scan. Continuous proces.

        -  Therapeutic measures (medication, miction clock): start after 10 weeks of observation or
           after video-urodynamic examination.

      Development of a therapeutic plan: adaptation of the micturition and drinking behaviour,
      anticholinergic therapy.
    

Intervention name(s): Questionnaire and micturition and drinking diaries; Clinical and functional examination (uroflowmetry, bladder scan and video-urodynamic examination); Adaptation of the drinking scheme; Anticholinergic therapy; Micturition clock
Intervention type(s): Procedure; Procedure; Behavioral; Drug; Behavioral
Intervention MeSH terms: Cholinergic Antagonists
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Laser CO2 Versus TENS After Reconstruction of the Rotator Cuff
Condition: Rotator Cuff Injury
MeSH terms: Rotator Cuff Injuries
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the most effective method between Transcutaneous
      Electrical Stimulation and Light Amplification by Stimulated Emission of Radiation therapy
      carbon dioxide therapy for pain control in the post-surgical rehabilitation of patients
      treated with reconstruction of the rotator cuff.
    

Detailed description: 
      To evaluate the most effective method between Transcutaneous Electrical Stimulation and Light
      Amplification by Stimulated Emission of Radiation therapy carbon dioxide for pain control in
      the post-surgical rehabilitation of patients treated with reconstruction of the rotator cuff
      and to evaluate, at the end of the rehabilitation period, the range of motion, the function
      gained and the quality of life comparatively in the two groups of patients treated with
      Transcutaneous Electrical Stimulation or Light Amplification by Stimulated Emission of
      Radiation therapy carbon dioxide therapy.
    

Intervention name(s): LASER CO2; TENS
Intervention type(s): Procedure; Procedure
Intervention description(s): The therapy is performed with the patient sitting, place the unit high above the shoulder with the following indicators: through a pulsed 40 Hz, distance between device and patient 60 cm, 10x15 cm area of application, power 2W; energy between 10 and 15 J/cm2; Transcutaneous Electrical Nerve Application of Stimulation occurs through the use of No. 3 channels (long head of biceps area (CLB), the supraspinatus muscle area, the area medial border of the scapula.
Duration: Twenty (20) minutes, mpulsi: 70 microsec, frequency: 100 Hz, intensity: between 20 and 40 mA.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: rotator cuff surgery; pain; exercise therapy
Safety and Efficacy of FURESTEM-RA Inj. in Patients With Moderate to Severe Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Safety and Efficacy of FURESTEM-RA Inj. in Patients With Moderate to Severe Rheumatoid
      arthritis
    

Detailed description: 
      Phase 1: Single center, open Phase 2a : Multi-center, randomized, double-blind, parallel,
      placebo Clinical Trial to Evaluate the Efficacy and Safety of FURESTEM-RA Inj. for Moderate
      to Severe Rheumatoid arthritis
    

Intervention name(s): FURESTEM-RA Inj; sterile saline
Intervention type(s): Biological; Other
Intervention description(s): The allogeneic umbilical cord blood-derived mesenchymal stem cells of each dose level as below were mixed into an IV bag containing 100 ml of sterile saline solution and the IV bag was gently massaged to obtain homogeneous mixture of the cell suspension.
Administer the constituted cell suspension by IV infusion to a subject. The infusion should be completed in 60 minutes using infusion pump.
Dose level 1: 5.0 x 10^7 cells /body 3 repeated intravenous injection at 4 week intervals
Dose level 2: 1.0 x 10^8 cells /body 3 repeated intravenous injection at 4 week intervals; sterile saline 3 repeated intravenous injection at 4 week intervals
Placebo were mixed into an IV bag containing 100 ml of sterile saline solution and the IV bag was gently massaged to obtain homogeneous mixture of the cell suspension.
Administer the constituted cell suspension by IV infusion to a subject. The infusion should be completed in 60 minutes using infusion pump.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: FURESTEM-RA Inj.; Rheumatoid Arthritis; Cell therapy
CNAP™ Monitor Study
Condition: Cardiac Surgery; Spinal Surgery
Study type: Observational

Summary: 
      A newly developed monitor for continuous non-invasive blood pressure monitoring (CNAP™
      Monitor 500; CNSystems Medizintechnik AG, Graz, Austria) provides beat-to-beat BP readings
      and is non-invasive. To make sure that anaesthesiologist can rely on and make clinical
      decisions based on values provided by the CNAP™ monitor, to demonstrate its reliability we
      will test it during the perioperative care of children.
    


Intervention name(s): CNAP
Intervention type(s): Device
Intervention description(s): Non-invasive blood pressure monitor
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Surgery patients at Nationwide Children's Hospital receiving an arterial line.
Effects of Stearidonic Acid-Containing Foods on Eicosapentaenoic Acid Levels in Red Blood Cells and Omega-3 Index
Condition: Sudden Cardiac Death; Sudden Cardiac Arrest; Cardiovascular Disease
MeSH terms: Cardiovascular Diseases; Death, Sudden, Cardiac; Death
Study type: Interventional

Summary: 
      The purpose of this study is to assess the effect of stearidonic acid when used as a food
      ingredient on eicosapentaenoic enrichment of red blood cell membranes and Omega-3 Index in
      men and women.
    


Intervention name(s): Sunflower Oil Softgels; EPA softgels; Sunflower Oil Food; SDA soybean Oil Food
Intervention type(s): Dietary Supplement; Dietary Supplement; Other; Other
Intervention description(s): 3 x 500 mg softgel capsules/day; 3 x 500 mg softgel capsules/day; 3 servings/day; 3 servings/day
Other intervention name(s): Food; Food
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Omega 3 fatty acids; Omega 3 Index; Stearidonic acid (SDA); Red Blood Cells; Lipids
T-Cell Turnover Following Vaccination With MVA85A
Condition: Tuberculosis
MeSH terms: Tuberculosis
Study type: Interventional
Phase: Phase 1

Summary: 
      This study examines the early immune response to a new vaccine (MVA85A) being developed to
      combat tuberculosis (TB).
    

Detailed description: 
      MVA85A is a promising new vaccine designed to prevent tuberculosis (TB) by dramatically
      boosting pre-existing responses to BCG, the only licensed vaccine against the disease at
      present. In BCG vaccinated individuals it induces a strong immune response. However little is
      known about the evolution of that response or of the kinetics of T-cells (the immune cells
      that respond to the vaccine) immediately following vaccination. Crucially, the outcome of
      this process may determine long term protection from disease.

      This study aims to define the early immune response to MVA85A and is the first to apply a
      safe, non-radioactive 'label' - deuterium - to measure T-cell turnover following vaccination.
      This labelling approach has been used successfully by the study collaborators to examine
      immune cell kinetics in human clinical studies in the UK over the last 8 years. The resulting
      data will provide insight into the immune response generated by MVA85A and aid in the future
      design and modification of other T-cell inducing vaccines.

      Group 1 (Immune responses only)

      Previous human studies of MVA85A have described the immune response to vaccination at fixed
      timepoints but not in between. The investigators will vaccinate four volunteers and measure
      immune responses daily for 14 days. This will provide important new data and aid
      interpretation of kinetics data from groups 2 and 3.

      Groups 2 & 3 (Labelling)

      Eight volunteers will be vaccinated and then receive a timed infusion of deuterated glucose.
      Blood will be collected during the follow up period to determine the rates of uptake and loss
      of label in responding immune cells.
    

Intervention name(s): MVA85A; Deuterated glucose infusion
Intervention type(s): Biological; Other
Intervention description(s): Vaccine. Dose: 1 x 10^8 plaque-forming units (pfu) given by intradermal injection into the deltoid region of the upper arm.; 6,6D2-glucose given as a timed intravenous infusion. The total dose of deuterated glucose will be 1g/kg volunteer body weight (up to a maximum of 60g).
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Tuberculosis; Lymphocyte kinetics; MVA85A; Deuterium
The Efficacy and Tolerance of Tacrolimus Sustained-release Capsules on Refractory Nephrotic Syndrome (RNS)
Condition: Nephrotic Syndrome
MeSH terms: Nephrotic Syndrome; Nephrosis; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      It is a pilot study to explore the efficacy and safety of Tacrolimus Sustained-release
      Capsules (ADVAGRAF) on 6-month induction therapy of Refractory Nephrotic Syndrome (RNS).
    


Intervention name(s): Tacrolimus Sustained-release Capsules (ADVAGRAF)
Intervention type(s): Drug
Intervention description(s): Started: 0.05-0.1mg/kg/d, one time per day, then adjusting the dose to maintain the blood level 5-10ng/ml in the induction treatment .
Other intervention name(s): ADVAGRAF
Intervention MeSH terms: Tacrolimus
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Refractory Nephrotic Syndrome; Tacrolimus
Fluorescence-guided Resection of Malignant Gliomas With 5-Aminolevulinic Acid
Condition: Brain Cancer; Brain Tumors; Cancer of Brain; Primary Brain Tumors; Brain Tumor, Primary
MeSH terms: Glioma; Brain Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of the study "Fluorescence-guided resection of malignant gliomas with
      5-Aminolevulinic acid (5-ALA) vs. conventional resection" is to determine how accurately
      contrast agent-accumulating tumour can be removed by primary surgery and to assess the
      clinical usefulness of this method.
    

Detailed description: 
      Malignant gliomas are locally invasive tumors that carry a dismal prognosis despite a
      combination of surgery, radiotherapy and chemotherapy. Cytoreductive surgery is generally
      considered beneficial but complete resection of contrast enhancing tumor is achieved in less
      than 20 % of patients, one reason being the difficulty in discerning marginal, enhancing
      tumor intraoperatively.

      Five-aminolevulinic acid (5-ALA) leads to the accumulation of fluorescent porphyrins in
      malignant gliomas, a phenomenon under exploration for intraoperative identification and
      resection of these tumors. This study investigated the benefit derived from
      fluorescent-guided resections using 5-ALA on surgical radicality, progression-free survival
      and morbidity.
    

Intervention name(s): 5-aminolevulinic acid (5-ALA)
Intervention type(s): Drug
Intervention description(s): 1.5 grams 5-ALA dissolved in 50 ml water, single dose, orally, 2-4 hours prior to surgery
Intervention MeSH terms: Aminolevulinic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Diagnostic
Comparison of the Cognitive and Motor Effects of Treatment Between an Immediate- and Extended-release Tacrolimus (Envarsus® XR) Based Immunosuppression Regimen in Kidney Transplant Recipients
Condition: Kidney Transplant Failure and Rejection
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The primary objective is to compare the effect of treatment with an immediate-release
      tacrolimus to an extended-release tacrolimus (i.e., Envarsus® XR) immunosuppressive regimen
      on cognitive and motor function in kidney transplant recipients
    

Detailed description: 
      Between four (4) months and 14 months after receiving a kidney transplant and, per standard
      of care (SOC), having been placed on an immediate-release (IR) tacrolimus immunosuppressant
      regimen, participants in this study will undergo cognitive and motor function testing and
      have a blood sample collected (BASELINE). Half of the participants will then be randomly
      converted to extended-release (XR) tacrolimus (Envarsus® XR) while the other half will remain
      on IR tacrolimus for the duration of the study. Both the IR and XR groups will repeat the
      cognitive and motor function testing and have a blood sample collected at 6, 12, and 24 weeks
      Post-BASELINE. A practice version of the cognitive and motor function tests will be
      administered no more than 60 days prior to the baseline visit (Pre-BASELINE). Alternate
      versions of the cognitive and motor tests will be used at each Post-BASELINE testing session
      to control for possible practice effects.

      The primary objective is to compare the effect of treatment with an immediate-release
      tacrolimus to an extended-release tacrolimus (i.e., Envarsus® XR) immunosuppressive regimen
      on cognitive and motor function in kidney transplant recipients.

      The secondary objective is to determine the factors that explain inter-individual variability
      in cognitive response. Pharmacokinetic and demographic factors will be explored. Variability
      in cognitive response between individuals can be large. A population approach (nonlinear,
      mixed effects) will be used. Measurement of drug concentration will be the dependent
      variable.
    

Intervention name(s): immediate-release tacrolimus; extended release tacrolimus
Intervention type(s): Drug; Drug
Intervention description(s): Standard of care for transplant patients; Experimental care
Other intervention name(s): Prograf; Envarsus®XR.
Intervention MeSH terms: Tacrolimus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Kidney; Transplant
Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LGD-6972 in Healthy Subjects and Subjects With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to evaluate the safety and tolerability of a range of single oral
      doses of LGD-6972 in healthy subjects. Additionally, the study will characterize the
      Pharmacokinetic profile in healthy subjects under fed and fasted conditions and in subjects
      with Type 2 Diabetes Mellitus under fasted conditions.
    

Detailed description: 
      This is a double-blind, placebo-controlled, randomized, sequential, ascending, single oral
      dose study conducted in 2 parts. Part 1 will consist of evaluation of LGD-6972 in healthy
      subjects (6 groups of 8 subjects each),and will be followed by Part 2, evaluation of LGD-6972
      in subjects with T2DM (1 group of 8 subjects).

      There will be a Screening Period of up to 30 days. Subjects who qualify for Group G (T2DM)
      will discontinue any anti-diabetic medication on Day -9 (1 week prior to confinement) for
      that group. Subjects in Groups A, B, C, D, E and F will be admitted to the study site on Day
      -1 , and Group G will be admitted to the study site on Day -2. Groups of 8 subjects will be
      randomized in a double-blind manner to receive either LGD-6972 or placebo (6 active:2
      placebo) as a single dose. Group D will receive treatment under fasted and fed conditions
      separated by a washout period of at least 14 days and up to 21 days. Each subject will be
      administered a specified dose of LGD-6972 or placebo under fasting conditions (and fed
      conditions for Group D to evaluate the effects of food on the LGD-6972 PK profile) and will
      be observed through the morning of Day 3 (48 hour post dose assessment). Safety assessments,
      LGD-6972 PK sample collection, and PD assessments will occur during this time. Subjects will
      be discharged from the study site after the 48 hour assessments and return to the study site
      on Day 7 for a follow up evaluation. After the follow up evaluation for each subject and
      evaluation of all safety and tolerability data, and any available PK data, the dose for the
      next group of subjects will be determined by the Safety Monitoring Panel (SMP).
    

Intervention name(s): LGD-6972; Placebo (Captisol®)
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Glucagon receptor antagonist
Diabetes Risk Reduction Through Eat, Walk, Sleep and Medication Therapy Management for Depressed Cambodians
Condition: Diabetes; Depression
MeSH terms: Diabetes Mellitus; Depression
Study type: Interventional

Summary: 
      The primary aim of the study is to compare the effect of three different interventions on
      lifestyle risk factors and biological risk factors for type 2 diabetes in depressed
      Cambodians. The three different interventions are lifestyle, lifestyle plus medication
      therapy management, and social services.
    

Detailed description: 
      Cambodian Americans have high risk for major depressive disorder and for type 2 diabetes.
      Depression is a known risk factor for diabetes. Some antidepressants can also increase risk
      of diabetes by causing weight gain. DREAM will test the effect of lifestyle and medication
      therapy management (MTM) compared to social services (control) on diabetes risk among
      depressed Cambodian Americans. Community health workers (CHWs) will deliver the lifestyle
      intervention and assist pharmacists with MTM. Lifestyle and biological risk factors for
      diabetes, such as depressive symptoms, HbA1c and insulin sensitivity, will be measured before
      and after the interventions.
    

Intervention name(s): Social Services; Lifestyle; Lifestyle Plus Medication Therapy Management
Intervention type(s): Behavioral; Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Diabetes; Depression; Medication therapy management; Community health workers; Cambodian; Refugee; Prevention