bioihbjkbjnl/mcl2 huggingface dataset:
The Learning Curve of NBI With Magnification in the Diagnosis of Colorectal Lesions
Condition: Colorectal Lesion
MeSH terms: Disease
Study type: Observational

Summary: 
      It exists a learning curve in using NBI with magnification to differentiating colorectal
      lesions.
    

Detailed description: 
      It is very useful to use narrow-band imaging and Sano CP analysis in the differential
      diagnosis of colorectal lesions. The endoscopists who had never used NBI or no knowledge of
      NBI can have effective and stable diagnostic accuracy after using NBI with magnification to
      diagnose 15 target and non-target lesions respectively.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        academic hospital endoscopist of digestive department
      
Biospecimen description: 
      if the lesion is neoplastic or sm deeper cancer, we just take biopsy.If the lesion is
      adenomatous or sm1-2 cancer,we do polypectomy, EMR or ESD to get the specimen.
    
Keywords: narrow band imaging; learning curve; colorectal; differential diagnosis; with colorectal lesion; NBI with magnification
Re-Treatment Study of Probuphine in Opioid Addiction
Condition: Opioid Dependency
MeSH terms: Opioid-Related Disorders; Behavior, Addictive
Study type: Interventional
Phase: Phase 3

Summary: 
      Probuphine (buprenorphine implant) is an investigational implant placed just below the skin
      containing buprenorphine (BPN). BPN is an approved treatment for opioid dependence. This is a
      6-month, open-label, re-treatment study that will confirm the safety and efficacy of
      Probuphine in patients who have previously completed the 6-month PRO-806 study with either
      Probuphine, placebo or sublingual buprenorphine.
    


Intervention name(s): Probuphine (buprenorphine implant)
Intervention type(s): Drug
Intervention description(s): Implantable formulation of buprenorphine made of buprenorphine HCl/ethylene vinyl acetate, considered a drug.
Intervention MeSH terms: Buprenorphine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: opioid dependence; opioid addiction; buprenorphine; implant; methadone; heroin; suboxone; opioid pain medication; opioid withdrawal
Protocols of IVF/ICSI in Poor Responders
Condition: Infertility, Female
MeSH terms: Infertility; Infertility, Female
Study type: Interventional
Phase: Phase 3

Summary: 
      Comparing two ovarian induction protocols in poor responders in IVF/ICSI cycles
    

Detailed description: 
      The two groups of poor responders are randomized into either; a minimal dose stimulation
      protocol involving letrozole, recombinant FSH and GnRH antagonist versus a microflare
      conventional protocol with OCP, GnRH agonist and high dose recombinant FSH, in their IVF/ICSI
      cycles, primary outcome will be the number of oocytes retrieved.
    

Intervention name(s): Minimal stimulation protocol; Microflare protocol; IVF/ICSI cycle
Intervention type(s): Drug; Drug; Procedure
Intervention description(s): Letrozole, Recombinant FSH, GnRH antagonist; OCP, GnRH agonist, Recombinant FSH; Involving ovum pickup and embryo transfer
Other intervention name(s): Ovarian induction protocol; Ovarian induction protocol
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Two groups of poor ovarian responders to be given two different induction protocols at the same time duration of the study
Masking: None (Open Label)
Primary purpose: Treatment
Pediatric Asthma Study Using Stepwise Treatment With Two Food And Drug Administration Approved Asthma Medications
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      This study was designed to evaluate if, in children with asthma, a stepwise treatment (five
      levels varying from once daily fluticasone propionate 100mcg until twice daily a fixed
      combination of salmeterol and fluticasone propionate 50/500 mcg) based on symptom scores
      alone results in a sub-optimal treatment when compared to treatment based on cumulative
      symptom scores and bronchial hyperresponsiveness (PD20 methacholine).
    


Intervention name(s): Salmeterol/Fluticasone propionate combination product; Fluticasone propionate
Intervention type(s): Drug; Drug
Other intervention name(s): Salmeterol/Fluticasone propionate combination product
Intervention MeSH terms: Fluticasone; Xhance; Salmeterol Xinafoate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Children; Asthma; bronchial hyperresponsiveness; symptoms
Safety and Efficacy of CryoCor™ Cryoablation for PAF
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional

Summary: 
      A multi-center, randomized, controlled study of cryoablation vs medical management for the
      treatment of PAF
    

Detailed description: 
      The purpose of this prospective, randomized multi-center clinical study is to establish the
      benefits of the CryoCor(TM) Cardiac Cryoablation System for treating symptomatic paroxysmal
      atrial fibrillation (PAF) in comparison to treatment with anti-arrhythmic medications alone.
      This study also evaluates the safety profile of the CryoCor(TM) Cardiac Cryoablation System
      when used in this same setting.
    

Intervention name(s): Cardiac CryoCor Cryoablation System; Medical management
Intervention type(s): Device; Drug
Intervention description(s): Treatment with CryoCor Cardiac Cryoablation system; Medical management- treatment with standard medical therapy, which includes anti-arrhythmic medications
Other intervention name(s): Ablation with the CryoCor ablation catheter; AAD treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cryoablation; atrial fibrillation
Positron Emission Tomography (PET) Study With [18F]AZD4694 and [11C]AZD2184, Candidate PET Ligands for Aβ Amyloid
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is carried out in order to investigate if [18F]AZD4694, compared to [11C]AZD2184,
      is a suitable PET ligand for in vivo imaging of Aβ amyloid depositions in the human brain. In
      the study the two PET ligands will be examined in both healthy volunteers and patients with
      Alzheimer's Disease. A whole body dosimetry scanning will be performed in 6 healthy
      volunteers to obtain human data to estimate a safe dose.
    


Intervention name(s): radioligand [18F]AZD4694; radioligand [11C]AZD2184
Intervention type(s): Drug; Drug
Intervention description(s): single dose of iv. admin. 1-2 times per subject; single dose of iv admin. 1 time per subject
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Alzheimer's Disease; PET; Phase 1; Positron Emission Tomography
Home Sleep and Circadian Phase: Mediators of Diabetes Risk
Condition: Sleep Deprivation; Diabetes; Circadian Dysregulation
MeSH terms: Sleep Deprivation; Chronobiology Disorders; Diabetes Mellitus
Study type: Observational

Summary: 
      The purpose of this study is to determine if deficient sleep and/or disruption with the
      body's internal clock ("circadian rhythms") are associated with diabetes risk. This study is
      being done to look at the possible relationships between sleep and risk of diabetes by
      examining sleep in the home and diabetes risk in the laboratory.
    


Observational model: Ecologic or Community
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        This study will recruit a total of 100 African Americans (AA) and 100 non-Hispanic whites
        (WH) with equal numbers of men and women in each group completing the entire study. Ages
        will be 21-50 years and body mass indices (BMI) will be <40 kg/m2.
      
Keywords: diabetes; sleep
EFFECT OF PRE EXTUBATION MANUAL HYPERINFLATION TECHNIQUE VS REGULAR EXTUBATION AFTER STERNOTOMY
Condition: Sternotomy
Study type: Interventional

Summary: 
      Post operative pulmonary complication (PPC) is one of the cause of mortality and morbidity
      after sternotomy. There is no accessible confirmation which shows the impact of Pre
      Extubation Manual Hyperinflation method with Regular Extubation procedure. After sternotomy
      manual hyperinflation technique is not taken during extubation. The objective of the study
      was to determine the effect of Pre Extubation Manual Hyperinflation technique VS regular
      Extubation technique on vitals and respiratory parameters in patients after Sternotomy.
    


Intervention name(s): Extubation; Manual Hyperinflation
Intervention type(s): Procedure; Procedure
Intervention description(s): Extubation is the removal of an endotracheal tube (ETT), which is the last step in liberating a patient from the mechanical ventilator.; Providing a larger tidal volume than baseline tidal volume to the patient and using a tidal volume which is 50% greater than that delivered by the ventilator
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Sternotomy; Extubation; Manual Hyperinflation
Cognitive Outcome After Surgical and Transcatheter Aortic Valve Replacement
Condition: Postoperative Delirium; Postoperative Cognitive Dysfunction; Transcatheter Aortic Valve Replacement; Surgical Aortic Valve Replacement
MeSH terms: Emergence Delirium; Postoperative Cognitive Complications; Cognitive Dysfunction
Study type: Interventional

Summary: 
      Aortic valve stenosis is one of the most common types of heart disease in the aging Western
      population. While surgical cardiac valve replacement (SAVR) is a standard therapy for
      patients with aortic stenosis, catheter-assisted aortic valve implantation (TAVI) has
      developed as an alternative to open-heart surgery, especially for high-risk patients.
      Recently, increased surgeon experience and improved transcatheter valve systems have led to a
      global trend to use TAVI in patients with low or intermediate risk. Although cognitive
      impairment after cardiac surgery is well known, the effect of TAVI on cognitive function has
      not yet been adequately investigated. The aim of this study is to compare the occurrence and
      progression of delirium, postoperative cognitive decline (POCD), cerebral infarction, and
      health-related quality of life (QOL) in patients with intermediate risk for catheter-assisted
      (TAVI) and surgical (SAVR) aortic valve replacement.
    

Detailed description: 
      The present project is a substudy of the DEDICATE Trial (ID: NCT03112980). It is a randomized
      intervention study taking place at the Kerckhoff-Klink Bad Nauheim Germany (Campus Justus
      Liebig University Giessen) involving 100 patients undergoing aortic valve replacement (TAVI
      vs. SAVR) with a focus on cognitive outcome. A detailed assessment of psychological and
      health-related functions will be performed before intervention, during hospitalization and 3
      months after intervention. During hospitalization, the occurrence and progression of delirium
      will be assessed with the Intensive Care Delirium Screening Checklist (ICDSC). Other
      cognitive data will be collected before and 3 months after surgery with a selected and
      comprehensive neuropsychological test battery, including the evaluation of attention, word
      fluency, executive functions and various functional areas of memory. In addition, parameters
      of health-related QOL will be collected before and 3 months after the intervention using the
      SF-36, and information on anxiety and depression will be collected using the Hospital Anxiety
      and Depression Scale (HADS). A few days after the intervention, magnetic resonance images of
      the brain will be acquired to assess cerebral infarction.
    

Intervention name(s): Transcatheter Aortic Valve Implantation; Surgical Aortic Valve Replacement
Intervention type(s): Procedure; Procedure
Intervention description(s): Transcatheter Aortic Valve Implantation; Surgical Aortic Valve Replacement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study of 5-FUci Versus CPT-11 Plus CDDP Versus S-1 Alone in Advanced Gastric Cancer
Condition: Gastric Cancer
MeSH terms: Stomach Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      To investigate the superiority of a combination of irinotecan and cisplatin and the
      non-inferiority of S-1 compared to continuous infusion of 5-FU in advanced gastric cancer
    

Detailed description: 
      From the results of our previous phase III study (JCOG9205), continuous infusion of
      5-fluorouracil has remained to be a control arm of this study. This study investigates the
      superiority of a combination of irinotecan plus cisplatin and non-inferiority of S-1, a oral
      fluoropyrimidine, compared to continuous infusion of 5-fluorouracil at the point of overall
      survival, and the planned number of enrolled patients is 690 (230/arm).
    

Intervention name(s): continuous infusion of 5-fluorouracil; combination of irinotecan and cisplatin; oral administration of S-1
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Fluorouracil; Irinotecan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: gastric cancer; 5-fluorouracil; irinotecan; cisplatin; S-1; advanced or recurrent gastric cancer
A 12-week Study to Compare the Efficacy and Safety of Fixed Combinations of Fenofibrate/Simvastatin 145/20mg and Fenofibrate/Simvastatin 145/40mg Tablets Versus Fenofibrate or Simvastatin Monotherapies in Subjects With Abnormal Blood Levels of Fats (Lipids) and at High Risk of Cardiovascular Disease
Condition: Dyslipidemia
MeSH terms: Cardiovascular Diseases; Dyslipidemias
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a double-blind, randomized study designed to compare the efficacy and safety of two
      fixed combinations of fenofibrate / simvastatin 145/20 mg and fenofibrate / simvastatin
      145/40 mg tablets vs. matching monotherapies in subjects with abnormal fat (lipids) in the
      blood and at high risk of cardiovascular disease. Fenofibrate is a treatment that lowers fat
      in blood. It is prescribed in patients with high levels of triglycerides (TG). The drug has
      been marketed in more than 80 countries since 1975. Simvastatin is also used for the
      treatment of patients with a high level of cholesterol. These have also been marketed
      worldwide for more than 20 years. It is important to treat high levels of fats in the blood
      because it has been shown that even mildly elevated level of lipids in the blood can lead to
      diseases of the blood vessels. It has been shown in several studies and in clinical practice
      that the combination of fenofibrate plus simvastatin can lead to improved effects on blood
      fats, compared to treatment with simvastatin or fenofibrate alone. The main objective of the
      study is to compare the efficacy of the two fixed-combinations (FC) -fenofibrate/simvastatin
      145/20 mg tablet and fenofibrate/simvastatin 145/40 mg tablet in reducing TG and increasing
      high density lipoprotein cholesterol (HDL-C) versus simvastatin 20 mg or 40 mg, and in
      reducing low density lipoprotein cholesterol (LDL-C) versus fenofibrate 145 mg.
    


Intervention name(s): Fixed Combination of Fenofibrate/simvastatin 145/20 mg; Simvastatin 20 mg; Fenofibrate 145 mg; Fixed Combination of Fenofibrate/simvastatin 145/40 mg; Simvastatin 40 mg
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Fenofibrate/simvastatin oval biconvex film-coated tablet, 145 mg / 20 mg, once daily, 12 weeks; Simvastatin generic tablet over-encapsulated, 20 mg, once daily, 12 weeks; Fenofibrate, tablet, 145 mg, once daily, 12 weeks; Fenofibrate/simvastatin film-coated tablet 145 mg / 40 mg, once daily, 12 weeks; simvastatin, generic tablet over-encapsulated, 40 mg, once daily, 12 weeks
Intervention MeSH terms: Simvastatin; Fenofibrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Fibrates; Dyslipidemia
Stepped-care Telehealth for Young Children With ASD
Condition: Autism Spectrum Disorder
MeSH terms: Autism Spectrum Disorder
Study type: Interventional

Summary: 
      This proof-of-concept study addresses the gap in the access to care literature by examining a
      stepped-care version of a telehealth naturalistic developmental behavioral intervention
      (NDBI), Online RIT. Online RIT is an interactive website introducing Reciprocal Imitation
      Training (RIT), an NDBI focused on enhancing social imitation. RIT uses a naturalistic
      behavioral approach to teach object and gesture imitation to young children with ASD within a
      play-based context. The efficacy of RIT has been demonstrated through a small randomized
      control trial, several single-subject design studies, as well as in independent replications.
      Prior research also suggests that parents can be taught to effectively use RIT with their
      children in person, and two single-subject design studies detail the development and
      feasibility testing of Online RIT plus therapist assistance. These preliminary data suggest
      Online RIT may serve as an ideal platform for examining the potential of individualized
      telehealth delivery formats, such as stepped-care. Therefore, the goal of this study was to
      compare a stepped-care format of Online RIT to a waitlist control condition to determine
      initial feasibility and effectiveness of this innovative intervention and service delivery
      model.
    


Intervention name(s): Online RIT
Intervention type(s): Behavioral
Intervention description(s): Online RIT presents RIT techniques in four sequential learning modules: (1) Setting Up For Success (2) Imitating your Child (3) Describing Play (4) Teaching Object Imitation. Each learning module includes an instructional video, quiz, interactive exercises, and at-home planning and reflection. The website also includes a video library, Frequently Asked Questions, downloadable visual aids, links to relevant external resources, and a customizable "dashboard" that allows users to track their individualized goals and the amount of time they have spent working on their goals (e.g., practice log).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Phase 4 Field Trial of the Unicirc Instrument With Tissue Adhesive
Condition: Male Circumcision
Study type: Interventional

Summary: 
      This is a field trial of the Unicirc instrument to excise the foreskin, plus use of
      cyanoacrylate tissue adhesive to seal the wound.
    


Intervention name(s): Unicirc instrument plus cyanoacrylate tissue adhesive
Intervention type(s): Procedure
Intervention description(s): Volunteers will be circumcised using the Unicirc surgical instrument and the incision will be sealed using cyanoacrylate tissue adhesive
Other intervention name(s): Unicirc; Cyanoacrylate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Circumcision; HIV prevention; Surgical device; Cyanoacrylate; Tissue Adhesive; voluntary
Role of Exercise for Wound Healing in the Larynx
Condition: Acute Phonotrauma
Study type: Interventional

Summary: 
      The purpose of this study is to explore quantitatively the hypothesis that "resonant voice,"
      may enhance recovery from acute laryngeal phonotrauma, based on molecular assays from human
      laryngeal secretions and secondarily, clinical tests.
    

Detailed description: 
      The objective is to use the following operationalized question: Does a voicing mode shown to
      correspond to high-amplitude, low impact vocal cord oscillations, "resonant voice," improve
      the amount and time-course of recovery from acute phonotrauma, compared to vocal rest or
      spontaneous speech, as measured with molecular assays (primarily) and with behavioral and
      clinical tests (secondarily)?
    

Intervention name(s): Resonant voice; Voice rest; Spontaneous speech
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): 4-hr of resonant voice exercise; 4-hr of complete refrain from any voice use
Other intervention name(s): 4-hr of conversational (normal) voice use
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
A Clinical Trial to Evaluate the Efficacy and Safety of Testosterone Gel
Condition: Adult Male Hypogonadism
MeSH terms: Hypogonadism
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a Phase 3 clinical trial in adult hypogonadal males with baseline serum testosterone
      concentrations <300 ng/dL. The purpose of this study is to evaluate the safety and efficacy
      of testosterone gel (2%) delivered using an applicator.
    


Intervention name(s): Testosterone gel (FE 999303)
Intervention type(s): Drug
Intervention MeSH terms: Testosterone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety, Pharmacokinetics and Efficacy of Bimagrumab in Overweight and Obese Patients With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Overweight
Study type: Interventional
Phase: Phase 2

Summary: 
      This study assessed the safety, pharmacokinetics and efficacy of bimagrumab when administered
      in overweight and obese patients with type 2 diabetes
    

Detailed description: 
      A non-confirmatory, randomized, subject and investigator blinded, placebo controlled,
      parallel-arm study, investigating a 48-week treatment period with i.v. bimagrumab 10 mg/kg in
      overweight and obese subjects with type 2 diabetes.

      Participants were randomized and assigned to one of the following 2 treatment arms in a ratio
      of 1:1:

      Arm 1: Bimagrumab 10 mg/kg up to maximum 1200 mg, every 4 weeks (12 doses) until week 44.

      Arm 2: Placebo, every 4 weeks (12 doses) until week 44.

      The study consisted of a screening baseline period of 3 weeks, treatment period of 48 weeks
      and then a follow-up period of 8 weeks.

      Treatment period visits were scheduled every 4 weeks until week 44. Administration of
      bimagrumab or placebo was done via an i.v. infusion over 30 minutes followed by flushing for
      15 minutes. Subjects were asked to return to the Investigator site for dosing approximately
      every 4 weeks during the treatment period. During those visits, subjects were evaluated for
      safety, tolerability, PK and efficacy. The treatment period ended approximately 4 weeks after
      the last dose administration.
    

Intervention name(s): BYM338 10 mg/kg; Placebo
Intervention type(s): Drug; Other
Intervention description(s): intravenous infusion every four weeks; intravenous infusion every four weeks
Other intervention name(s): Bimagrumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: type 2 diabetes; obesity; DXA; MRI