bioihbjkbjnl/mcl2 huggingface dataset:
Effect of TachoSil® on Incidence of Symptomatic and Radiographic Lymphoceles After Extended Pelvic Lymph Node Dissection in Prostate and Bladder Cancer.
Condition: Prostate or Bladder Cancer
MeSH terms: Urinary Bladder Neoplasms; Lymphocele
Study type: Interventional
Phase: Phase 4

Summary: 
      Pelvic lymph node dissection (PLND) is the most accurate staging tool to determine lymph node
      involvement in prostate and bladder cancer. The main complication of PLND is development of a
      lymphocele, which can cause symptoms including lower abdominal pain, leg or penile/scrotal
      edema, bladder outlet obstruction, deep venous thrombosis or infection/sepsis. The incidence
      of radiographic (asymptomatic) and symptomatic lymphoceles following PLND varies between
      12,6-63% and 1,6-33% respectively. Medicated sponges such as Tachosil® are indicated in
      surgery for improvement of haemostasis and to promote tissue sealing. They could reduce
      lymphocele development by increased tissue sealing, due to a mechanical effect of the sponge
      itself and a lymphostatic effect of the included thrombin and fibrinogen. Our goal is to
      prospectively assess the lymphostatic effect of Tachosil(r) in patients undergoing
      transperitoneal PLND with or without radical prostatectomy or PLND with bladder cancer
      surgery.
    


Intervention name(s): 1 TachoSil hemostatic sponge (9,5 cm x 4,8 cm) placed on each side on the external iliac artery.
Intervention type(s): Drug
Intervention description(s): at the end of surgery
Intervention MeSH terms: Hemostatics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: patients,; undergoing; pelvic; lymph; node; dissection.
Prediction of Fluid Responsiveness Using Dynamic Preload Indices During Arthroscopic Shoulder Surgery in the Beach Chair Position
Condition: Shoulder Arthroscopy
Study type: Observational

Summary: 
      The beach chair position (BCP) has been commonly used for shoulder arthroscopic surgery.
      Hemodynamic instability is frequently encountered problem associated with BCP. In addition,
      high rates of cerebral desaturation events have been reported during surgery in BCP. Although
      fluid loading could alleviate hypotension associated with BCP, it may lead to volume
      overload. As an alternative to static indices, dynamic preload indices such as pulse pressure
      variation (PPV) and stroke volume variation (SVV) were reported to be sensitive predictors of
      fluid responsivness in several surgical condition. The investigators will examine the
      abilities of PPV and SVV to predict fluid responsivness during shoulder arthroscopic surgery
      in BCP. Using transesophageal echocardiography (TEE), the investigators will directly
      estimate the change of cardiac output during BCP.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        patients undergoing shoulder arthroscopic surgery in the beach chair position
Comparison Trial of OPA-15406 Ointment in Pediatric Patients With Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 3

Summary: 
      To demonstrate the superiority of the investigational medicinal product (IMP; 0.3% OPA-15406
      ointment, 1% OPA-15406 ointment, or vehicle) to the vehicle when administered twice daily for
      4 weeks using success rate in Investigator's Global Assessment (IGA) at Week 4 as the primary
      endpoint in pediatric patients with Atopic Dermatitis (AD).
    


Intervention name(s): 0.3% OPA-15406; 1% OPA-15406; Placebos
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Twice daily; Twice daily; Twice daily
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
68Ga-PSMA PET/CT in Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      The objectives of this study are to replicate the safety and efficacy of 68Ga-PSMA PET/CT and
      as a diagnostic and decision making tool in the management prostate cancer patients.The
      primary endpoints of the study are the incidence of adverse events (AE) in the study
      population up to 7 days following the scan, and the sensitivity and specificity of 68Ga-PSMA
      PET/CT vs CT on a per-patient and per-lesion basis.
    

Detailed description: 
      Positron emission tomography / computer tomography (PET/CT) is a nuclear medicine diagnostic
      imaging procedure based on the measurement of positron emission from radiolabeled tracer
      molecules in vivo. A radiotracer in use today is 68Ga-HBED-CC-PSMA (DKFZ-11) - hereinafter
      abbreviated 68Ga-PSMA - which is a radiolabeled urea-based ligand for prostate specific
      membrane antigen (PSMA) PET/CT. Imaging with 68Ga-PSMA PET is used to characterize and
      localize prostate cancer in humans in vivo. There is extensive data in the literature showing
      the value of 68Ga-PSMA PET/CT imaging in accurately staging and restaging prostate cancer.
      The objectives of this study are to replicate the safety and efficacy of 68Ga-PSMA PET/CT and
      to establish our ability to reproduce results from the literature using 68Ga-PSMA PET/CT as a
      diagnostic and decision making tool in the management prostate cancer patients. During the
      study eligible prostate cancer patients will undergo one 68Ga-PSMA PET/CT. The primary
      endpoints of the study are the incidence of adverse events (AE) in the study population up to
      7 days following the scan, and the sensitivity and specificity of 68Ga-PSMA PET/CT vs CT on a
      per-patient and per-lesion basis.
    

Intervention name(s): 68Ga-HBED-CC-PSMA PET/CT
Intervention type(s): Drug
Intervention description(s): 68Ga-HBED-CC-PSMA PET/CT Scan
Other intervention name(s): 68Ga-PSMA-11
Intervention MeSH terms: Gallium 68 PSMA-11
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
A Study of the Safety and Efficacy of Injectable Risperidone in the Prevention of Bipolar Mood Episodes
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine if risperidone is effective and safe in the
      prevention of mood episodes in patients with bipolar 1 disorder.
    

Detailed description: 
      RISPERDAL CONSTA (risperidone long-acting injection) may provide substantial improvement, by
      reducing patient non-compliance, in the long-term treatment of bipolar I disorder. This is a
      randomized (patients are assigned different treatments based on chance), double-blind,
      (neither the patient nor the physician knows whether drug or placebo is being taken, or at
      what dosage) placebo-controlled study to explore the safety and effectiveness of RISPERDAL
      CONSTA in the prevention of mood episodes in patients with bipolar 1 disorder. This study
      includes 5 periods: a screening period lasting up to 1 week; an open-label RISPERDAL (oral
      risperidone) treatment period lasting 3 weeks; an open-label RISPERDAL CONSTA stabilization
      period lasting 26 weeks; a double-blind period lasting up to 24 months; and an open-label
      extension with RISPERDAL CONSTA lasting 8 weeks. Efficacy will be assessed using the Young
      Mania Rating Scale (YMRS), Montgomery-Åsberg Depression Rating Scale (MADRS), Clinical Global
      Impressions - Severity (CGI-S) scale, Medical Outcomes Study Short Form 36 (SF-36), and the
      Personal and Social Performance (PSP) scale. Safety will be evaluated throughout the study
      and includes assessment of adverse events, clinical laboratory tests (including hematology,
      serum chemistry, blood glucose/lipid profile, prolactin, and urinalysis); electrocardiograms
      (ECGs), vital signs (pulse and blood pressure), physical examination, body mass index (BMI),
      and the Extrapyramidal Symptom Rating Scale (ESRS). Oral risperidone (flexible dosage) 1 to 6
      mg/day for the first 3 weeks. Risperidone LAI i.m. injections (12.5mg, 25 mg, 37.5 mg, or 50
      mg) given every 2 weeks for up to approximately 2.6 years (only 6 months for patients
      receiving placebo during DB-period)
    

Intervention name(s): Risperdal Consta; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 12.5, 25, 37.5 or 50mg intramuscular (IM) injection every 2 weeks; Matching placebo intramuscular (IM) injection every 2 weeks
Intervention MeSH terms: Risperidone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Mood episodes; Bipolar 1 disorder; Intramuscular Injectable; risperidone; safety and efficacy
A Study to Evaluate the Efficacy and Safety of ESK-001 in Patients With Plaque Psoriasis
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a multi-center, randomized, double-blind, placebo-controlled study in patients with
      moderate to severe plaque psoriasis.
    

Detailed description: 
      This study will consist of a 4 week screening period, 12 week treatment period, and a 4 week
      follow up period for a total of 20 weeks. Each participant will be randomized to receive
      ESK-001 or placebo daily for 12 weeks. An open label extension study will be available for
      those patients who complete the study.
    

Intervention name(s): ESK-001; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral tablet; Oral tablet
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Clinical Study to CMDHA0101 as Compared to PowerFill® for Temporary Penile Enhancement
Condition: Small Penis; Penile Enhancement
Study type: Interventional

Summary: 
      The investigators aimed to confirm the efficacy and safety of transdermal penis enlargement
      for 24 weeks after CMDHA0101 injection in subjects who wanted penile enlargement in male
      patients with small-penis syndrome *.

      *Small-penis syndrome is the anxiety of thinking one's penis is too small - even though it
      isn't.
    

Detailed description: 
      This study was designed as a 24-week, randomized, blinded, active control trial.

      If a subject signing a clinical trial agreement and satisfying the selection / exclusion
      criteria is enrolled in this clinical trial, he / she will receive the medical device for
      clinical testing at the baseline time, return to his / her home after the training . At 4
      weeks, 12 weeks, and 24 weeks after the application of the medical device for clinical
      testing at baseline, the safety, penile girth, length, and satisfaction of the subject were
      evaluated. 24 weeks after application, the clinical trial sponsor (or trustee) retrieves the
      data necessary for the analysis of results, such as case records, for the purpose of validity
      and safety evaluation
    

Intervention name(s): CMDHA0101; PowerFill®
Intervention type(s): Device; Device
Intervention description(s): Maximum injection dose : 22 ml; Maximum injection dose : 22 ml
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Hyaluronic acid; Small Penis; Penile Enhancement
Piloting a Novel, Mobile Cognitive Training Tool for Patients With Major Depressive Disorder (MDD)
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional

Summary: 
      To assess the efficacy of a mobile-device-deployed cognitive emotional treatment for
      depression (Moodify) versus an active control treatment (commercially available computer
      games).
    

Detailed description: 
      The study will involve a randomized, controlled, double-blind trial to assess the efficacy of
      a mobile-device-deployed cognitive emotional treatment for depression (Moodify) versus an
      active control treatment (commercially available computer games). Moodify is comprised of a
      novel continuous performance task (CPT) to improve cognitive slowing and lethargy often
      present in cases of major depressive disorder. This training method is based on an existing,
      validated cognitive training paradigm (tonic and phasic attention training, TAPAT1; WIRB
      Study No. 1126399). Moodify will also employ two additional cognitive training modules
      previously validated in this and other clinical populations.
    

Intervention name(s): Computerized Plasticity-Based Adaptive Cognitive Training; Commercially available computerized training
Intervention type(s): Other; Other
Other intervention name(s): Moodify; Games
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Effect of Nafamostat Mesilate in Prolonging Filter Patency With Patients on Continuous Renal Replacement Therapy
Condition: Acute Kidney Injury
MeSH terms: Acute Kidney Injury
Study type: Interventional
Phase: Phase 4

Summary: 
      Continuous renal replacement therapy (CRRT) has been considered as an effective modality for
      renal replacement therapy in hemodynamically unstable patients within intensive care unit
      (ICU) except for the necessity of anticoagulation. The severity and peculiarities of ICU
      patients often make it equivocal to use anticoagulation. This is a prospective randomized
      controlled study to show the difference in filter life span and adverse event between HF1000
      (nafamostat mesilate) group and M100 (heparin-free) group.
    


Intervention name(s): Anticoagulation with nafamostat mesilate
Intervention type(s): Drug
Intervention description(s): Initial dose of nafamostat mesilate is 20mg/hr. Dosage is adjusted from 10mg to 30mg/hr according to patients' status. For priming, two vial of nafamostat mesilate was dissolved in 2mL of 5% glucose fluid, and then mixed with 1000mL of normal saline. After carefully removing air bubble from the circuit with the prepared fluid, nafamostat mesilate was dissolved with 15 mL of 5% glucose fluid and loaded in anticoagulation line with starting dose of 20mg/hr.
Other intervention name(s): futhan
Intervention MeSH terms: Nafamostat
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: nafamostat mesilate; heparin; continuous renal replacement therapy
Aerobic Capacity and Physical Fitness Level of Adolescents With PCOS
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Syndrome
Study type: Observational

Summary: 
      Polycystic Ovary Syndrome (PCOS) is associated with hyperandrogenism, hyperinsulinemia and
      insulin resistance starting in the perimenarchal period. Insulin resistance also increases
      the risk of developing glucose intolerance, type 2 diabetes, hypertension, dyslipidemia and
      cardiovascular disorders. Studies on adult women with PCOS show that their aerobic capacity
      is affected. Therefore, in this study; it was aimed to compare the physical and
      cardiovascular fitness levels of adolescent PCOS patients with healthy adolescents.
    

Detailed description: 
      Polycystic Ovary Syndrome (PCOS) is associated with hyperandrogenism, hyperinsulinemia and
      insulin resistance starting in the perimenarchal period. Insulin resistance also increases
      the risk of developing glucose intolerance, type 2 diabetes, hypertension, dyslipidemia and
      cardiovascular disorders. Studies on adult women with PCOS show that their aerobic capacity
      is affected. Therefore, in this study; it was aimed to compare the physical and
      cardiovascular fitness levels of adolescent PCOS patients with healthy adolescents.Total fat
      and muscle ratios will be measured with the bioelectrical impedance test (BIA) instrument for
      body composition evaluation of individuals in both groups. Body mass index (BMI), waist/hip
      and waist/height ratios will be recorded. The level of cardiovascular fitness will be
      evaluated with the PACER test, which is among the Fitness Gram Test Protocol. For physical
      fitness level, muscular strength parameter will be evaluated with hand dynamometer and knee
      extensor muscle strength, and muscular endurance parameter will be evaluated with sit-up and
      push-up tests. Participants' physical activities will be evaluated with the Adolescent
      Physical Activity Questionnaire (PAQ-A).The quality of life of individuals with PCOS will be
      evaluated with the Polycystic Ovary Syndrome Quality of Life-50 Scale.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Healthy group: Being in the adolescent group, not having any chronic disease and being
        willing to participate in the study.

        Patient group: Being in the adolescent group, being diagnosed with polycystic ovary
        syndrome and being willing to participate in the study
      
Keywords: aerobic capacity; physical fitness
Single-port Thoracoscopic Sympathicotomy for Treatment of Raynaud's Phenomenon, a Feasibility Study
Condition: Raynauds
MeSH terms: Raynaud Disease
Study type: Interventional

Summary: 
      The goal is to investigate the effect of a single-port R3 sympathicotomy on microvascular
      circulation in the affected fingers. This effect is analysed by performing cooling
      plethysmography and nailfold capillary microscopy bilaterally, following a unilateral,
      single-port thoracoscopic sympathicotomy.
    

Detailed description: 
      Raynaud's phenomenon is discoloration, discomfort and numbness or pain in the fingers and
      toes as a result of excessively reduced blood flow due to sympathetic induced vasospasms, in
      response to a change in temperature or emotional stress. It usually affects multiple fingers
      of both hands and comes in frequent attacks, with little or no discomfort in between them.
      Current treatment consists of stepped-care, including preventive measures optimizing digital
      blood flow, oral and intravenous medical therapy aimed at improving microvascular
      circulation, surgical neuromodulation to achieve vasodilatation and neurostimulation.

      While surgical sympathectomy is an established treatment of Raynaud's phenomenon, its more
      invasive nature has prevented widespread application as an initial therapy. After
      introduction of minimally invasive surgical techniques in recent years, the investigators
      have further optimized the endoscopic sympathicotomy procedure performed on hyperhidrosis
      patients, now needing only a single 1 cm port for a detailed, panoramic view of the
      sympathetic chain (1). This minimal invasive technique has proven to be a safe, efficient and
      reproducible treatment for several indications and seems also suitable for Raynaud's
      patients.

      In this feasibility study, the researchers want to investigate the effect of a single-port R3
      sympathicotomy on microvascular circulation in the affected fingers. This effect is analysed
      by performing cooling plethysmography and nailfold capillary microscopy bilaterally,
      following a unilateral, single-port thoracoscopic sympathicotomy.
    

Intervention name(s): Sympathicotomy R3
Intervention type(s): Procedure
Intervention description(s): sympathicotomy R3 consists of transecting the sympathetic chain at the third costal level, cranial of the ganglia, leaving the ganglia themselves untouched
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Patient Palatability and Preference of 3 Potassium Binders in Patients With Chronic Kidney Disease and Hyperkalaemia
Condition: Chronic Kidney Disease + Hyperkalaemia +/- Heart Failure
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Hyperkalemia
Study type: Observational

Summary: 
      This non-interventional, Phase IV, exploratory, cross-over, randomised, single-blind, active
      comparator-controlled study has been designed to measure the palatability and preference of
      Lokelma® versus Veltassa® versus S/CPS in patients with dialysis and non-dialysis chronic
      kidney disease (CKD) and hyperkalaemia (HK). The sponsor hypothesizes that palatability, in
      terms of taste, texture, smell, and mouthfeel, will score higher (better) for Lokelma when
      compared with Veltassa and S/CPS.
    

Detailed description: 
      This non-interventional, Phase IV, exploratory, cross-over, randomised, single-blind, active
      comparator-controlled study has been designed to measure the palatability and preference of
      sodium zirconium cyclosilicate (hereafter referred to as Lokelma®) versus calcium patiromer
      sorbitex (hereafter referred to as Veltassa®) versus sodium polystyrene sulphonate (SPS) or
      calcium polystyrene sulphonate (CPS) (hereafter referred to as S/CPS) in patients with
      dialysis and non-dialysis chronic kidney disease (CKD) and hyperkalaemia (HK). The sponsor
      hypothesizes that palatability, in terms of taste, texture, smell, and mouthfeel, will score
      higher (better) for Lokelma when compared with Veltassa and S/CPS. Each objective will be
      analysed per country. In addition, the difference in results per regions and overall may be
      explored.
    

Intervention name(s): Calcium Polystyrene Sulphonate 15g/60 mL water; Lokelma® 5 g/45mL water; Lokelma® 10 g/45 mL water; Veltassa® 8,4 g/80mL water; Sodium Polystyrene Sulphonate 15g/60 mL water
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): K+ binder, not for treatment but for tasting (sip-and-spit taste test); K+ binder, not for treatment but for tasting (sip-and-spit taste test); K+ binder, not for treatment but for tasting (sip-and-spit taste test); K+ binder, not for treatment but for tasting (sip-and-spit taste test); K+ binder, not for treatment but for tasting (sip-and-spit taste test)
Intervention MeSH terms: Calcium; Polystyrene sulfonic acid
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients with dialysis and non-dialysis CKD and HK
      
Keywords: palatability; Lokelma; hyperkalaemia
How Fat Influences the Brain
Condition: Fat Processing in the Brain
Study type: Interventional

Summary: 
      The aim of the current study was to investigate the effect of a high versus a low fat meal
      (operationalized by high and low fat yoghurt) on homeostatic and gustatory brain regions.
    


Intervention name(s): intake of high or low fat yoghurt
Intervention type(s): Dietary Supplement
Intervention description(s): intake of 500 ml of a high fat yoghurt on one day and intake of 500 ml of a low fat yoghurt on the other day
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Fat ingestion; hypothalamus; insula; fMRI; CBF