bioihbjkbjnl/mcl2 huggingface dataset:
Urinary Retention After Removing Urinary Catheter at 24 Hour Versus 48 Hour in Patients With Vaginal Surgery
Condition: Urinary Retention; Pelvic Organ Prolapse
MeSH terms: Urinary Retention; Prolapse; Pelvic Organ Prolapse
Study type: Interventional

Summary: 
      Comparison incident of urinary retention in patients with vaginal surgery of pelvic organ
      prolapse, who removed urinary catheter at 24 hours versus 48 hours after surgery
    

Detailed description: 
      Vaginal surgery of pelvic organ prolapse needs to insert urinary catheter for monitoring
      post-operative complication, hemodynamic status, and prevention post-operative urinary
      retention. Urinary retention occur 2.4 - 43% after pelvic organ prolapse surgery, whereas
      retaining urinary catheter is common cause of urinary tract infection, often
      hospital-acquired infection. At Rajavithi hospital always remove urinary catheter at 48 hour
      after surgery. Accordingly, appropriated time for removing urinary catheter in patients with
      vaginal surgery of pelvic organ prolapse is unclear. This study aims to reduce timing for
      removing urinary catheter after vaginal surgery, not increase urinary retention and
      re-catheterization and reduce urinary tract infection and day of hospital stay.
    

Intervention name(s): Removing urinary catheter
Intervention type(s): Procedure
Intervention description(s): Removing urinary catheter after vaginal surgery of pelvic organ prolapse
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Urinary Retention; Pelvic Organ Prolapse; Vaginal surgery; Urinary catheter
Islet Transplantation in Type 1 Diabetic Patients
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      Our hypothesis is that a successful clinical islet transplant program can be established at
      the University of Wisconsin using a steroid -free, sirolimus- and low dose tacrolimus - based
      immunosuppressive drug regimen (Edmonton protocol). We intend to answer the following
      research questions: 1) will treatment of islet transplant recipients with thiazolidinediones
      (i.e. pioglitazone) enhance post-transplant islet function and reduce the number of islets
      necessary to achieve adequate metabolic control? 2) which type 1 diabetic patients are
      optimal candidates for islet transplantation (i.e. islet transplant alone or islet after
      kidney transplantation)? 3) Can cadaver donor pancreases, which are ordinarily discarded and
      not used for pancreas transplantation be used for islet transplantation?
    


Intervention name(s): Thiazolidinedione
Intervention type(s): Drug
Intervention description(s): Thiazolidinedione vs. no intervention with standard immunosuppression using Edmonton Protocol
Intervention MeSH terms: 2,4-thiazolidinedione
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Bioequivalence Study of Bisoprolol Fumarate Tablet 10 mg Under Fasting Condition
Condition: Fasting
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, open Label, balanced, two-treatment, two-period, two-sequence, single
      dose, crossover pivotal study. The purpose of this study is to assess the bioequivalence
      between Test Product and the corresponding Reference Product under fasting condition in
      normal, healthy, adult human subjects.
    

Detailed description: 
      Objective of this pivotal study was to assess the bioequivalence between Test Product:
      Bisoprolol Fumarate Tablet 10 mg of Ipca Laboratories Limited, India and the corresponding
      Reference Product: Zebeta® (Bisoprolol Fumarate) Tablets 10 mg of Duramed Pharmaceuticals
      Inc., USA under fasting condition in normal, healthy, adult, human subjects in a randomized
      crossover study.

      The study was conducted with 24 healthy adult subjects. In each study period, a single 10 mg
      dose of either test or reference was administered to the subjects as per the randomization
      schedule in each study period with about 240 mL of water at ambient temperature in sitting
      position.

      The duration of the clinical phase was approximately 15 days including washout period of at
      least 10 days between administrations of study drug in each study period.
    

Intervention name(s): Bisoprolol Fumarate Tablet 10 mg; Bisoprolol
Intervention type(s): Drug; Drug
Intervention description(s): 10 mg tablet once a day; 10 mg tablet once a day
Other intervention name(s): Test Product; Zebeta®
Intervention MeSH terms: Bisoprolol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Three M Study (Malabsorption, Microbiota, Mini-Gastric Bypass)
Condition: Obesity (Disorder)
MeSH terms: Malabsorption Syndromes; Obesity
Study type: Interventional

Summary: 
      Bariatric surgery represents the best therapeutic option to induce sustainable weight loss
      and to solve serious comorbidities improving the life-expectancy and the quality of life.
      Actually the choice of the procedure is based on the surgeon's and patients preference . Mini
      gastric bypass(MGB) is an emerging procedure offering excellent results in terms of weight
      loss and comorbidities (mainly metabolic) control. On the other hand, recent data indicated
      that the gut microbiota may mediate some of the beneficial effects of bariatric surgery and
      changes in the composition and diversity of the gut microbiota have been observed after RY
      Gastric Bypass (RYGB) in humans as well as in mice. However, there are no prospective
      investigations on Gut Microbiota changes after MGB, despite the procedure is described as
      "malabsorptive" and there are no studies comparing gut microbiota shift and malabsorption
      entity in humans after RYGB vs MGB. Thereafter prospective data on the incidence of bile
      reflux esophageal lesions after MGB are lacking.

      The aim of the present multicentric prospective comparative study is to evaluate
      malabsorption and gut microbiota shift after laparoscopic RYGB vs MGB at 1 year.
    


Intervention name(s): Mini Gastric Bypass; Roux en Y Gastric Bypass
Intervention type(s): Procedure; Procedure
Intervention description(s): Standardization of the techniques will be guaranteed:
Mini Gastric Bypass Arm
Roux en Y Gastric Bypass arm All patients will have intraoperative measurement of the whole length of bowel from Treitz ligament to the ileocecal junction (expected range 6-8 m).The common limb will be therefore about 2/3 of total small bowel length.; Standardization of the techniques will be guaranteed:
Mini Gastric Bypass Arm
Roux en Y Gastric Bypass arm All patients will have intraoperative measurement of the whole length of bowel from Treitz ligament to the ileocecal junction (expected range 6-8 m).The common limb will be therefore about 2/3 of total small bowel length.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Malabsorption, Mini Gastric Bypass, Roux en Y Gastric Bypass
Preliminary Results for the Double-dose Adenovirus-mediated Adjuvant Therapy Improving Outcome of Liver Transplantation in Patients With Advanced Hepatocellular Carcinoma
Condition: Liver Cancer; Hepatocellular Carcinoma
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Study type: Interventional
Phase: Phase 2

Summary: 
      HCC patients with tumors >5 cm in diameter, regardless of involvement in the intrahepatic and
      extrahepatic portal branches participated in the study. Patients were randomized allocated in
      liver transplantation (LT) only group and LT plus ADV-TK therapy group. All patients received
      orthotopic liver transplantation; in the LT plus ADV-TK group, ADV-TK therapy was delivered
      to patients twice.
    


Intervention name(s): LT; ADV-TK; ganciclovir
Intervention type(s): Procedure; Drug; Drug
Intervention description(s): Orthotopic LT
Other intervention name(s): liver transplantation; adenovirus-thymidine kinase
Intervention MeSH terms: Ganciclovir; Ganciclovir triphosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hepatocellular carcinoma; liver transplantation; adenovirus-thymidine kinase; gene therapy
Safety and Immunogenicity Study of AdCLD-CoV19-1: A COVID-19 Preventive Vaccine in Healthy Volunteers
Condition: Covid19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1 clinical trial to assess the safety and immunogenicity of AdCLD-CoV19-1 in
      healthy adults.
    

Detailed description: 
      This is a dose-escalation, multi-center, open-label, Phase 1 clinical trial. We assess the
      safety of AdCLD-CoV19-1 and immune responses against SARS-CoV-2. DSMB will evaluate safety
      when events occurred during the whole study period.
    

Intervention name(s): AdCLD-CoV19-1
Intervention type(s): Biological
Intervention description(s): Replication deficient adenoviral vector based COVID-19 prevention vaccine containing recombinant gene of SARS-CoV-2 spike protein
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: COVID-19; Prevention; Vaccine
Follow-up of Prader Willi Syndrome Infants Treated by Oxytocin and Comparison With Not-treated Infants.
Condition: Prader-Willi Syndrome
MeSH terms: Prader-Willi Syndrome; Syndrome
Study type: Interventional

Summary: 
      The objective of this study is to collect data on tolerance and effects of early treatment
      with oxytocin in children with Prader Willi Syndrome aged from 3 to 4 years and to compare
      these infants with not treated age-matched infants with Prader Willi Syndrome.
    

Detailed description: 
      In accordance with recommendations of regulatory authorities, we want to collect long term
      data of patients treated with oxytocin before the age of 6 months. Moreover clinical
      observations of these infants support long term effects on communication skills, global
      development and behaviour.
    

Intervention name(s): Oxytocin; Control
Intervention type(s): Drug; Other
Intervention description(s): Infant included in the ancient study (repeated administrations of oxytocin in infants with Prader Willi Syndrome aged from 0 to 6 months); Not treated.
Intervention MeSH terms: Oxytocin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Prader-Willi; Oxytocin; Communication skills; Oral skills; Brain activity; Hormonal disease
Specific Neurotechnical Strength Training (NeuroTraining)
Condition: Neuromuscular Adaptations
Study type: Interventional

Summary: 
      This study aims to apply a novel study methodology using high density electromyography
      (HDEMG) to know what are the mechanisms underlying the structural and functional changes
      obtained by two different training methods, commonly used, facilitating their understanding,
      study and subsequent application according to specific needs.
    

Detailed description: 
      Different training methodologies have previously shown similar results in the improvement of
      structural or functional characteristics such as hypertrophy or strength. However, the
      different nature of their methods has suggested for years the possibility that different
      neuromuscular mechanisms could be behind these observed characteristics.

      The development of a new technology, such as high-density electromyography (HDEMG), capable
      of studying new properties previously hidden from assessment methods, such as the speed of
      nerve impulse propagation or the frequency of motor unit discharge, has allowed a more
      thorough study of the mechanisms.

      This study aims to apply this new study methodology to know what are the mechanisms
      underlying the changes at the structural and functional level obtained by two different
      training methods, commonly used, facilitating their understanding, study and subsequent
      application according to specific needs.

      For this reason, the main hypothesis is the generation of different neuromuscular mechanisms
      and adaptations by executing, for 4 weeks, two different training methodologies, obtaining a
      dissociation between the results obtained at the structural level (hypertrophy), functional
      (generation of strength) and HDEMG analysis of the central and peripheral characteristics of
      the neuromuscular system in each of the programs studied.
    

Intervention name(s): Speed Loss 20% Strength Training; Reduced Rest Time Strength Training
Intervention type(s): Other; Other
Intervention description(s): Strength training based on the control of speed loss in execution.; Strength training based on a protocol that includes reduced rest times between sets.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Two randomly allocated parallel groups
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Keywords: Strength training; Neuromuscular adaptation
Early-onset Rectal Cancer
Condition: Rectal Cancer
MeSH terms: Rectal Neoplasms
Study type: Observational

Summary: 
      The present study aimed to review the characteristics and outcome of early-onset rectal
      cancer in a subset of Egyptian patients aged 40 years or less. Since the previous studies
      assessed this point of research in CRC overall, the investigators opted to focus upon rectal
      cancer alone since it may represent a separate category, distinct from colon cancer, in this
      age group with regards to presentation, tumor behavior, and outcome.
    


Intervention name(s): Total mesorectal excision
Intervention type(s): Procedure
Intervention description(s): Radical resection of rectal cancer and draining lymph nodes
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Patients of either gender aged 40 years or less who presented with rectal cancer of any
        stage
A Study of Effect of Food and a Proton Pump Inhibitor on Selpercatinib (LY3527723) in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to assess the effect of food on how fast selpercatinib gets
      into the bloodstream and how long it takes the body to remove it after a high-fat meal, and
      the effect of a change in gastric pH after multiple doses of omeprazole on how fast
      selpercatinib gets into the bloodstream and how long it takes the body to remove it when
      administered under fasted and fed conditions in healthy participants. The study will also
      evaluate the safety and tolerability of selpercatinib in healthy participants. The study will
      last up to 33 days excluding the screening period.
    


Intervention name(s): Selpercatinib; Omeprazole
Intervention type(s): Drug; Drug
Intervention description(s): Administered orally; Administered orally
Other intervention name(s): LY3527723; LOXO-292
Intervention MeSH terms: Omeprazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Fear of Activity in Situations (FActS) - Study 2016
Condition: Chronic Heart Failure; Fear of Movement (Fear of Physical Activity)
MeSH terms: Heart Failure
Study type: Observational

Summary: 
      The aim of the study is to evaluate the psychometric properties of the newly developed Fear
      of Activity in Situations - Heart Failure (FActS-HF 15) scale. The FActS-HF 15 is a
      questionnaire assessing fear of physical activity (fear of movement) in patients with chronic
      heart failure. FActS-HF 15 assesses cognitions and emotions that can occur during physical
      activity, independent of avoidance behavior. Firstly, the study aims at evaluating the
      instrument's reliability and validity and to investigate associations of fear of physical
      activity with demographic, medical, and psychosocial patient characteristics. Secondly, the
      study aims at assessing everyday physical activity using accelerometric measures to test the
      hypothesis that fear of physical activity in patients with heart failure is related with
      lower actual physical activity.
    


Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        The study population will consist of adult patients with diagnosed chronic heart failure of
        all underlying diagnoses. Patients have to be outpatients at time of study participation.
        They will be recruted in primary care clinics, and heart failure outpatient clinics in
        Germany.
      
Keywords: heart failure; fear of physical activity; motor activity
Visual Assessment for Pressure-time Curve
Condition: Mechanical Ventilation
Study type: Observational

Summary: 
      Airway pressure-time (P-t) curve and stress index (SI) assessment have been proposed to guide
      the mechanical ventilation settings and minimize ventilator-induced lung injury.
    

Detailed description: 
      The stress index (SI), which has been proposed to guide the mechanical ventilation settings
      and minimize ventilator-induced lung injury. It reflects the change of respiratory compliance
      during inspiration. Value of SI equals to 1 that indicates a constant compliance, whereas
      values lower and higher than 1 indicate increase and decrease of compliance over inspiratory
      time, suggesting tidal recruitment and tidal hyperinflation, respectively. Based on the
      different values of SI showing different shapes, SI of straight curve equals to 1, SI of
      concave curve lower than 1 and convex curve higher than 1, the investigators speculated that
      the SI value could be reliably and accurately estimated by visual inspection of the P-t
      curve.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        intubated and mechanical ventilated by volume-control ventilation with constant flow
Clinical Trial to Assess the Efficacy and Safety of 'INNOCELL Immuncell-LC' With Temozolomide in Newly Diagnosed Glioblastoma of Korea
Condition: Glioblastoma
MeSH terms: Glioblastoma
Study type: Interventional
Phase: Phase 3

Summary: 
      This clinical study was planned in order to assess the superiority of INNOCELL Corp.
      "Immuncell-LC" in aspects of therapeutic efficacy and safety when administered with
      Temozolomide to glioblastoma patients when compared with the control group who did not
      receive administration of the drug.
    

Detailed description: 
      <Primary Purpose> Compare clinical efficacy of group treated with cell theraputic INNOCELL
      Immuncell-LC evaluated by progression free survival with that of untreated group.

      <Secondary Purpose> Compare clinical efficacy of group treated with INNOCELL Immuncell-LC, a
      drug for treating glioblastoma evaluated by overall survival, therapy reaction, EORTC
      QLQ-C30, and Karnofsky Performance Status (KPS) and that of untreated group, and evaluate
      adverse reactions, clinical pathological tests, and its safety.
    

Intervention name(s): Activated T lymphocyte(Immuncell-LC)
Intervention type(s): Drug
Intervention description(s): Efficacy/Effects: Removal of minimal residual cancer after removal of brain tumors and relapse prevention
Method of administration and quantity: Test Drug: Per 60kg of average adult body weight, administer 100mg that contains 109~2x1010 lymphocytes for one hour intravenously. (Duration of administration can be controlled based on patient conditions)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Glioblastoma; Newly diagnosed Glioblastoma
PET MYOCARDIAL Blood Flow Comparison to Coronary CTA and CT-FFR
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Study type: Interventional

Summary: 
      The broad, long-term objective of this pilot study is to develop an optimal, clinically
      usable, non-invasive evaluation of Coronary Artery Disease (CAD) in the setting of stable
      angina which provides both anatomic and functional information.

      Patients already scheduled to undergo Invasive coronary catheterization (ICA) for the
      clinical indication of angina will be recruited to under go stress-rest Positron Emission
      Tomography-Coronary CT Angiography-Fractional Flow Reserve (PET-cCTA-cFFR)
    

Detailed description: 
      This is a single cohort, technology assessment study. Thirty-five patients presenting with
      stable angina and a moderate pretest likelihood for CAD who are already scheduled to undergo
      invasive coronary angiography (ICA) for the clinical indication of angina will be recruited
      to undergo a cCTA examination with FFR followed immediately by regadenoson stress-rest PET on
      the same PET/CT scanner.

      Sensitivity, specificity, NPV, PPV of CTA-cFFR will be obtained using the reference standard
      of standard of care ICA with FFR for each epicardial coronary artery.

      Segmental stress PET MBF will be compared to presence or absence of a coronary artery
      stenosis ≥ 50% diameter on CCTA and ICA.
    

Intervention name(s): PET-cCTA-cFFR
Intervention type(s): Diagnostic Test
Intervention description(s): patients presenting with stable angina and a moderate pretest likelihood for CAD who are already scheduled to undergo ICA for the clinical indication of angina will be recruited to undergo PET-cCTA-cFFR
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Safety and Efficacy Trial of a RNActive®-Derived Prostate Cancer Vaccine in Hormone Refractory Disease
Condition: Hormonal Refractory Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to determine the efficacy and safety of a new vaccine in hormone
      refractory prostate cancer
    

Detailed description: 
      Immunotherapy of prostate cancer is a promising approach for the treatment of advanced or
      recurrent forms of prostate cancer. Recently, immunotherapy of prostate cancer has been
      facilitated by the identification of a number of prostate specific antigens that are
      expressed in healthy and tumor prostate tissues. For prostatectomized patients, such antigens
      offer ideal targets for immunotherapy as they are only present in tumor but not in healthy
      tissue. The use of prostate specific antigens in a cancer vaccine is one attractive option
      for cancer immunotherapy.
    

Intervention name(s): CV9103
Intervention type(s): Biological
Intervention description(s): Over a period of 23 weeks 5 vaccinations with CV9103 will be administered.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hormonal refractory prostate cancer; RNA vaccine