bioihbjkbjnl/mcl2 huggingface dataset:
Structural Imaging and Cognitive Functions in Adult Stem Cell Transplant Recipients Treated With Chemotherapy Alone or in Combination With Radiotherapy
Condition: Acute Myeloid Leukemia; Acute Lymphoblastic Leukemia; Acute Undifferentiated Leukemia; Biphenotypic Leukemia; Myelodysplastic Syndrome; Non-Hodgkin's Lymphoma
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Myelodysplastic Syndromes
Study type: Observational

Summary: 
      The purpose of this study is to learn about possible changes in brain anatomy and in thinking
      abilities, such as memory skills, in patients with cancer who receive treatment with
      chemotherapy alone or in combination with total body radiation before undergoing stem cell
      transplantation.
    


Intervention name(s): MRI and cognitive evaluation; MRI and cognitive evaluation; brain MRI study and a brief neuropsychological evaluation
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): Patients will undergo a brain MRI study and a brief neuropsychological evaluation, at the time of enrollment for controls and prior to undergoing the conditioning treatment required for the stem cell transplant for patients. A follow-up MRI and cognitive evaluation will be performed approximately 12 months after the transplant for patients.; Pt will undergo a Magnetic Resonance Imaging (MRI) study of the brain and a brief neuropsychological evaluation, at the time of enrollment for healthy controls and prior to undergoing the conditioning treatment required for the stem cell transplant for patients (Baseline/Time 1).; A brain MRI study and a brief neuropsychological evaluation will be performed at baseline (Time 1). A follow-up MRI and cognitive evaluation will be performed and about 12 months after the baseline for healthy controls
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects will be identified and recruited to participate in the study by Memorial
        Sloan-Kettering Cancer Center (MSKCC) and Weill Cornell Medical Center (WCMC).
      
Keywords: MRI
Internet-based Emotion Regulation Intervention for Sexual Health
Condition: Sexual Dysfunction; Sexual Dysfunctions, Psychological
MeSH terms: Sexual Dysfunctions, Psychological
Study type: Interventional

Summary: 
      Introduction: Emotion regulation difficulties have been associated with mental disorders and
      sexual dysfunctions. Traditional face-to-face transdiagnostic emotion regulation
      interventions have shown positive results for emotional and personality disorders. Only
      recently have the effects of these interventions on sexual health started to be investigated.
      Internet-delivered psychological interventions have several advantages over face-to-face
      interventions, such as cost-effectiveness, accessibility and suitability for people who
      experience shame because of their stigmatized problematic behaviors and those who avoid
      seeking help. The aims of the SHER 2 study are: a) determine the efficacy of an
      Internet-based emotion regulation intervention for sexual health and sexual satisfaction,
      and; b) explore the effects of the intervention on (1) emotion regulation skills; (2) mental
      health; (3) sexual self-perception.
    


Intervention name(s): Emotion regulation skills training
Intervention type(s): Behavioral
Intervention description(s): The intervention will involve an online emotion-regulation skills training for individuals with sexual problems. It will last for 8 weeks, encompassing psycho-educational and emotion-regulation skills components. Every week participants will gain access to a different intervention module of the training, containing videos, presentation slides, written support material and a recommendation of activities to be completed until the following week of training. Participants are expected to dedicate 30 minutes to one hour per week to complete each module.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants are assigned to one of two groups for the duration of the study. 50% of participants will be assigned to the intervention group while the other 50% will be assign to a waitlist control condition. The waitlist group will have access to the intervention after 6 months.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: internet intervention; emotion regulation; sexual health
Enhancing Gluteus Maximus Recruitment
Condition: Muscular Weakness
MeSH terms: Muscle Weakness
Study type: Interventional

Summary: 
      Can participants enhance gluteus maximus recruitment during a single-leg squat test following
      a neuromuscular training program?
    


Intervention name(s): Exercise
Intervention type(s): Other
Intervention description(s): Exercise to improve gluteus maximus recruitment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Knee; Hip; Muscle Strength; Electromyography; Biomechanical Phenomena
Oral Anticoagulation in Hemodialysis
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional
Phase: Phase 4

Summary: 
      The investigators refer to the trial with clinicaltrials.gov indentifier NCT02610933 entitled
      Effect on Vascular Calcification of Replacing Warfarin by Rivaroxaban With or Without VitK2
      in Hemodialysis Patients.

      After termination of this trial, included patients will be asked to participate in the
      extension trial by continuing the treament of their respective allocation arm. No new
      intervention will be done.
    

Detailed description: 
      The investigators refer to the trial with clinicaltrials.gov indentifier NCT02610933 entitled
      Effect on Vascular Calcification of Replacing Warfarin by Rivaroxaban With or Without VitK2
      in Hemodialysis Patients.

      After termination of this trial, included patients will be asked to participate in the
      extension trial by continuing the treament of their respective allocation arm. No new
      intervention will be done. Relevant endpoints like death, cardiovascular events and bleeding
      episodes will be registered.
    

Intervention name(s): Rivaroxaban 10 MG Oral Tablet; MK-7 2000µg thrice weekly; Vitamin K Antagonist - Drug
Intervention type(s): Drug; Dietary Supplement; Drug
Intervention description(s): replacement of warfarin by rivaroxaban; dietary supplement of vitamin K2 MK-7 2000µg thrice weekly; treatment with a vitamin K antagonist
Intervention MeSH terms: Vitamin K; Rivaroxaban
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: hemodialysis; rivaroxaban; vitamin K2
Anesthetic Requirement and Stress Hormone Response During Surgery in Spinal Cord-injured Patients
Condition: Complete Spinal Cord Injury; Surgery
MeSH terms: Spinal Cord Injuries
Study type: Observational

Summary: 
      Spinal cord injury (SCI) reduces anesthetic requirements and stress hormonal responses.
      Anesthetic requirements and stress hormone response are compared in SCI patients undergoing
      anesthesia with sevoflurane supplemented with clinically equivalent doses of either N2O or
      remifentanil.
    

Detailed description: 
      Nitrous oxide (N2O) is often used for anesthetic adjuvant, but may be associated with side
      effects and toxicities. Remifentanil shares characteristics with N2O, including
      anesthetic-reducing and antinociceptive effects and a rapid recovery. Anesthetic requirements
      and stress hormone response in SCI patients undergoing anesthesia with sevoflurane
      supplemented with clinically equivalent doses of either N2O or remifentanil. Forty-five SCI
      patients scheduled to undergo pressor sore surgery below the level of the injury are randomly
      allocated to receive either sevoflurane alone (control, n=15), or combined with 67% N2O
      (n=15) or target-controlled infusions of 1.37 ng/mL remifentanil (n=15). Sevoflurane
      concentration is titrated to maintain a Bispectral Index (BIS) value of 40-50. Measurements
      include end-tidal sevoflurane concentrations, mean arterial blood pressure (MAP), heart rate
      (HR), and plasma catecholamine and cortisol concentrations.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        ASA physical status II, with chronic, clinically complete cord injuries scheduled for a
        surgery for pressure sore below the level of the neurologic lesion under general
        anesthesia.
      
Keywords: spinal cord injury; stress hormone; surgery; bispectral index value; volatile anesthetic
Efficacy and Safety of SHR-1209 Combined With Lipid-lowering Agents in Patients With Hypercholesterolemia
Condition: Non-familial Hypercholesterolemia; Mixed Hyperlipidemia
MeSH terms: Hyperlipidemia, Familial Combined; Hyperlipoproteinemia Type V; Lipidoses; Hypercholesterolemia; Hyperlipidemias; Hyperlipoproteinemias
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate the efficacy, safety, pharmacokinetics and immunogenicity of SHR-1209
      subcutaneous administration in patients with non-familial hypercholesterolemia and mixed
      hyperlipidemia after lipid-lowering therapy
    


Intervention name(s): SHR-1209 ;placebo; SHR-1209 ;placebo; SHR-1209 ;placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): SHR-1209 and placebo 150 mg subcutaneous injection once every 4 weeks for 48 weeks; SHR-1209 and placebo 300 mg subcutaneous injection once every 8 weeks for 48 weeks; SHR-1209 and placebo 450 mg subcutaneous injection once every 12 weeks for 48 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: SHR-1209 combined with lipid-lowering agents
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
FACE-Q in Blepharoplasty
Condition: Dermatochalasis of Upper Eyelid
MeSH terms: Cutis Laxa
Study type: Observational

Summary: 
      The aim of this study is to assess the effect of two different suturing techniques in
      patients undergoing bilateral upper eyelid blepharoplasty on the results of the FACE-Q Eye
      Module questionnaire for measuring patient-reported outcomes as well as on the blinded
      objective assessment by two experienced surgeons using the same questionnaire.

      We aim to investigate the differences of the 2 most common techniques of skin closure with
      running cutaneous or subcuticular Nylon (6-0 Prolene) sutures in upper blepharoplasties and
      their effect on postoperative complications and scar formation. Besides the functional
      outcomes (visual field) and objective postoperative results, we aim to measure the patients'
      satisfaction using the FACE-Q Eye Module as a comprehensive, procedure- and disease-specific
      patient-reported outcome instrument.
    


Intervention name(s): Blepharoplasty
Intervention type(s): Procedure
Intervention description(s): 90 patients undergoing bilateral upper eyelid blepharoplasty are randomly assigned to a suturing technique (running cutaneous or subcuticular Nylon (6-0 Prolene) sutures). Steri-strips will be used until suture removal 7 days after blepharoplasty for patient blinding.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Ninety patients will be enrolled in the study. Eligibility will be assessed at the first
        visit based on inclusion/exclusion criteria.
Bioavailability Study of 3 Tablet Formulations vs. Capsule Formulation of JNJ-56021927 in Fasting Healthy Male Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the pharmacokinetics (PK - the study of the way a
      drug enters and leaves the blood and tissues over time) and relative bioavailability (the
      extent to which a drug or other substance becomes available to the body) of JNJ-56021927,
      when administered as 3 tablet formulations (test) compared with JNJ-54781532 softgel capsule
      formulation (reference) in healthy male participants under fasted conditions at a single dose
      of 240 milligram (mg).
    

Detailed description: 
      This is a randomized (study medication assigned to participants by chance), open-label (all
      people know the identity of the intervention), single-center, 4-treatment, parallel design (a
      medical research study comparing the response in two or more groups of participants receiving
      different interventions) study of a single dose of 240 mg JNJ-56021927. The duration of study
      will be approximately of 78 days per participant. The study consists of 3 parts: Screening
      phase (that is, 21 days before study commences on Day 1); Open-label Treatment phase
      (consists of 4 parallel single-dose treatments); and End-of-Study (completion of the Hour
      1344 PK sampling on Day 57, or upon early withdrawal). All the eligible participants will be
      randomly assigned to 1 of the 4 possible treatments: Treatment A (240 mg dose as softgel
      capsule); Treatment B (240 mg dose as Tablet Formulation 1); Treatment C (240 mg dose as
      Tablet Formulation 2); or Treatment D (240 mg dose as Tablet Formulation 3). Participants
      will fast overnight from food and fluids (excluding non-carbonated water) for at least 10
      hours before study drug administration on Day 1. Blood samples will be collected pre-dose and
      over 1,344 hours (Day 57) after dosing for the determination of JNJ-56021927 concentration
      and its active metabolite. Relative bioavailability of 3 tablet formulations as compared to
      the softgel capsule formulation of JNJ-56021927 will be evaluated primarily. Participants'
      safety will be monitored throughout the study.
    

Intervention name(s): JNJ-56021927 Softgel Capsule; JNJ-56021927 Tablet Formulation 1; JNJ-56021927 Tablet Formulation 2; JNJ-56021927 Tablet Formulation 3
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Single oral dose of JNJ-56021927 240 mg softgel capsule on Day 1.; Single oral dose of JNJ-56021927 240 mg Tablet Formulation 1 on Day 1.; Single oral dose of JNJ-56021927 240 mg Tablet Formulation 2 on Day 1.; Single oral dose of JNJ-56021927 240 mg Tablet Formulation 3 on Day 1.
Other intervention name(s): ARN-509
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy; JNJ-56021927; JNJ-56142060; ARN-509
A Trial to Evaluate the Effect of Food on LEO 152020
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      A phase 1 trial in healthy people to evaluate the food effect on LEO 152020 in an open-label
      design using film-coated tablets
    

Detailed description: 
      This trial will evaluate the pharmacokinetics and tolerability of 2 single doses of
      film-coated tablets in the morning after fasting or after a high-fat breakfast. The 2 doses
      will be separated by a washout period.
    

Intervention name(s): LEO 152020 Tablet
Intervention type(s): Drug
Intervention description(s): film-coated tablet
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Single dose, cross-over with food effect
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: Healthy
Study of Olmesartan Medoxomil (CS-866) in Patients With Chronic Glomerulonephritis or Diabetic Nephropathy
Condition: Chronic Glomerulonephritis; Diabetic Nephropathy
MeSH terms: Kidney Diseases; Diabetic Nephropathies; Glomerulonephritis; Chronic Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The treatment period was 16 weeks, the initial dose, 5 mg, was unforcedly titrated to 10 mg,
      20 mg and 40 mg after confirming tolerance at weeks 4, 8 and 12. The primary endpoint for
      efficacy was the change in the urinary protein/creatinine ratio from baseline to the end of
      treatment. The secondary endpoint was creatinine clearance (Ccr).
    


Intervention name(s): olmesartan medoxomil
Intervention type(s): Drug
Intervention description(s): olmesartan medoxomil tablets, once daily
Intervention MeSH terms: Olmesartan; Olmesartan Medoxomil
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chronic Glomerulonephritis; Diabetic Nephropathy; Angiotensin II Receptor Blocker; Urinary Protein
Vortioxetine for Posttraumatic Stress Disorder
Condition: Post-Traumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional
Phase: Phase 4

Summary: 
      Post-traumatic stress disorder (PTSD) can result from having experienced or witnessed a
      traumatic event. Patients with PTSD symptoms can sometimes experience symptom relief after
      treatment with antidepressants; however, few patients experience complete symptom relief.
      There is a need to develop new treatments for PTSD.

      This study will evaluate if 12 weeks of using Vortioxetine relieves PTSD symptoms.
      Vortioxetine has been approved for the treatment of depression; however, Vortioxetine has not
      been approved by the Food and Drug Administration for the treatment of PTSD.
    

Detailed description: 
      Patients included in the study will either take the study medication or will take a placebo,
      a pill without the active medication. This will be determined by chance like a flip of a
      coin.

      Study procedures will include taking study medication and coming to regular in-clinic visits.
      Depending on the study visit, study tests may include the following: medical evaluations,
      physical exams, body measurements, vital signs, blood and urine tests, pregnancy tests,
      genetic testing, heart function monitoring, clinical and psychiatric measures,
      neuropsychological testing (for example, investigators will test how well you remember words
      or how fast you perform a certain task), a function test (for example, investigators will
      test how well you perform certain daily tasks), and a test to measure your startle response.
      A startle response is an unexpected response by a sudden activity.
    

Intervention name(s): Placebo; Vortioxetine
Intervention type(s): Drug; Drug
Intervention description(s): Placebo pill matching Vortioxetine.; Immediate Release 10 mg. Vortioxetine Pill
Intervention MeSH terms: Vortioxetine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: PTSD,; trauma; stress disorder; post-traumatic stress disorder; anxiety disorder
Early Outcomes of Radical Debridement Versus no Debridement Under Different Surgical Procedures
Condition: Spinal Tuberculosis
MeSH terms: Tuberculosis; Tuberculosis, Spinal
Study type: Interventional

Summary: 
      Whether radical debridement is necessary for the treatment of thoracic and lumbar
      tuberculosis is still questionable. The objective of this prospective randomized study was to
      compare the outcomes of radical debridement versus no debridement under different surgical
      procedures for the treatment of thoracic and lumbar tuberculosis.
    

Detailed description: 
      Seventy-four thoracic and lumbar tuberculosis patients with a neurological function of grade
      D and E underwent surgeries from January 2009 to January 2014. All patients were divided into
      group A and group B by taking the drawing of lots. In group A, radical debridement, bone
      graft and instrumentation were performed. In group B, isolated posterior instrumentation
      without debridement were performed in all cases and drainage of iliopsoas abscess via
      laparoscopy in 2 cases. The operative time, blood loss, visual analogue score (VAS),
      erythrocyte sedimentation rate (ESR), kyphotic angle, Frankel grading, fusion rate and
      complications were evaluated.
    

Intervention name(s): no debridement
Intervention type(s): Procedure
Intervention description(s): It is a spinal surgery performed with isolated posterior instrumentation without debridement.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Hydromorphone vs Fentanyl in Children Undergoing Tonsillectomy Surgery
Condition: Obstructive Sleep Apnea; Tonsillitis
MeSH terms: Tonsillitis; Sleep Apnea, Obstructive
Study type: Interventional
Phase: Early Phase 1

Summary: 
      A RCT to compare hydromorphone versus fentanyl for pain control following tonsillectomy or
      adenotonsillectomy surgery.
    

Detailed description: 
      This is a randomized clinical trial with masked assessment, comparing recovery indices for
      patients receiving intermediate acting versus short acting opioid analgesia using
      hydromorphone or fentanyl as intraoperative analgesics. An otherwise standardized anesthetic
      and analgesic regimen will be utilized, consistent with routine care at SLCH. Patients will
      be randomized 1:1 in block sizes of 5 per group. Patients will be randomized to receive
      either hydromorphone or fentanyl throughout the perioperative period by opening a sealed
      protocol envelope.
    

Intervention name(s): Hydromorphone; Fentanyl
Intervention type(s): Drug; Drug
Intervention description(s): Patients will be randomized to one of two opioids for the treatment of post-operative pain.; Fentanyl
Intervention MeSH terms: Fentanyl; Hydromorphone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
A Multicenter Study on Recombinant Human Thrombopoietin in Management of ITP in Pregnancy
Condition: Immune Thrombocytopenia; Pregnancy
MeSH terms: Thrombocytopenia; Purpura, Thrombocytopenic, Idiopathic
Study type: Interventional
Phase: Phase 3

Summary: 
      The project was undertaking by Qilu Hospital of Shandong University and other well-known
      hospitals in China. Aims at evaluating efficacy and safety of rhTPO in management of ITP in
      pregnancy.
    

Detailed description: 
      The investigators are undertaking a multicenter, open-labeled, pilot study of 30 ITP patients
      in pregnancy from Qilu Hospital of Shandong University and other well-known hospitals in
      China. ITP patients in pregnancy who failed to respond to prednisone, IVIG and developed
      refractoriness to platelet transfusion will be given rhTPO intravenously at a dose of 300U/kg
      every day. Dose will be tapered to 300U/kg every other day when platelet count rise over
      50×10^9/L. Maintenance will be continued after delivery and the dose will be further reduced
      to 300U/kg per week. Platelet count, bleeding and other symptoms will be evaluated before and
      after treatment. Adverse events will be recorded throughout the study.
    

Intervention name(s): rhTPO
Intervention type(s): Drug
Other intervention name(s): TPIAO
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: recombinant human thrombopoietin; immune thrombocytopenia; pregnancy