bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of Endostapled Anastomoses for Laparoscopic Gastric Bypass (EEA-LGB)
Condition: Morbid Obesity
MeSH terms: Obesity, Morbid
Study type: Interventional

Summary: 
      Laparoscopic gastric bypass surgery is a common procedure being performed for the treatment
      of morbid obesity. The procedure consists of a creation of a small gastric pouch and
      rerouting the small bowel to bypass the stomach and duodenum. There are two anastomoses in
      this procedure: the gastrojejunostomy and the jejunojejunostomy. Potential complications
      after gastric bypass include gastrointestinal bleeding and leaks. Gastrointestinal bleeding
      can occur at any staple line including the gastrojejunostomy. Potential methods for
      prevention of postoperative gastrointestinal bleeding include oversewing of the anastomosis
      or the use of a smaller stapler height. We hypothesize that the use of staplers with smaller
      staple height will significantly result in a lower rate of staple line bleeding and possible
      leaks.
    

Detailed description: 
      RATIONALE:

        1. Gastrointestinal (GI) bleeding can occur in up to 4% of cases. GI bleeding is associated
           with significant morbidity which may include transfusion and possible re-operation

        2. Leaks at the gastrojejunostomy can be potentially life threatening and ranged from 1% to
           2%.

      HYPOTHESES:

      The smaller circular stapler may be associated with a lower rate of intraoperative
      intraluminal bleeding and postoperative gastrointestinal bleeding than the larger one.
    

Intervention name(s): 3.5 mm vs 4.8 mm Stapler During Laparoscopic Gastric Bypass
Intervention type(s): Procedure
Intervention description(s): The procedure consists of a creation of a small gastric pouch and rerouting the small bowel to bypass the stomach and duodenum. There are two anastomoses in this procedure: the gastrojejunostomy and the jejunojejunostomy.
Other intervention name(s): Covidien small 3.5 mm Circular Stapler; Covidien large 4.8 mm Circular Stapler
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Morbid Obesity; Laparoscopic Gastric Bypass; Staple Line Hemorrhage
Preventive Effect of Celecoxib on Sorafenib-related Hand Foot Syndrome, a Single Center, Randomized Controlled Clinical Trail
Condition: Hepatocellular Carcinoma
MeSH terms: Carcinoma, Hepatocellular; Hand-Foot Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      Hepatocellular carcinoma (HCC) is a common fatal malignant tumor, although with the
      popularity of health examination, most patients were diagnosed as HCC in advanced stages so
      far. Sorafenib is currently recognized worldwide as the only effective treatment for advanced
      HCC. However, sorafenib need long-term medication, and will bring a series of side effects,
      including, hand, foot and comprehensive syndrome (Hand-foot syndrome, HFS) limbs swelling,
      rash, peeling, pain.Occurrence rate of HFS is about 21%-51%, which seriously affect patient's
      quality of life.Besides, this side effects appeared to be dose-related.When severe HFS
      happened, sorafenib need to reduce dosage or discontinue administration, which could
      seriously affect the patient's survival. Therefore, investigators designed this prospective
      randomized controlled study to explore preventive effect of celecoxib for sorafenib related
      HFS, the influence on the quality of life in patients with, and also the synergistic
      anti-tumor effect of celecoxib in combination with sorafenib on HCC. This study will explore
      horizon of improving treatment for sorafenib in patients with advanced HCC,quality of life
      and tumor control.
    


Intervention name(s): Celecoxib; Sorafenib
Intervention type(s): Drug; Drug
Intervention description(s): Patients from experimental group will take celecoxib, except for sorafenib; Each group will receive sorafenib as basic treatment.
Intervention MeSH terms: Celecoxib; Sorafenib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hepatocellular carcinoma; sorafenib; celecoxib
Chronic Sleep Restriction
Condition: Other Conditions That May Be A Focus of Clinical Attention
Study type: Observational

Summary: 
      Sleep is a physiological state considered essential for health and human survival. The
      prevalence of chronic sleep restriction has increased in modern society, as well as the
      effects of the same health concerns about various aspects, including the physiological and
      neurobehavioral. The objective of this study is to identify the neurobehavioral and
      physiological responses of healthy men with different needs of total sleep time (TST)
      submitted to chronic sleep restriction. Participants in this study will be 30 male
      volunteers, aged between 20 and 35 years, divided into three groups: Group 1 (n = 10) with
      TST ≤ 6 hours (h), Group 2 (n = 10) with TST ≥ 9h and Group 3 (n = 10): TST with between 7
      and 8h. The TST will be established by the constant and continuous use of actigraphy for 10
      days prior to the onset of the experimental protocol. All volunteers will undergo medical and
      polysomnography (PSG) examination to detect the presence or not of changes in sleep as well
      as other health problem that prevents their participation in the study. The experimental
      protocol consists of a basal night of sleep, five consecutive nights of chronic sleep
      restriction to 25% of TST in the beginning night and a night of recovery, which will be
      allowed to sleep the sleep pattern. Each night will have PSG monitoring and when wake up in
      each day, the volunteer will undergo tests to assess the physiological and neurobehavioral
      variables. The significance level will be 5% (p ≤ 0.05).
    


Intervention name(s): Chronic Sleep Restriction
Intervention type(s): Other
Intervention description(s): All volunteers will undergo 25% of sleep restriction of their total sleep time at the beginning sleep for five consecutive days. The nights will be monitored by polysomnography.
Other intervention name(s): Chronic; Sleep; Restriction
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Community sample, residents of Sao Paulo city
      
Keywords: Sleep; Polysomnography; Reaction Time; Sleep Deprivation; Psychophysiology; Chronic sleep restriction; healthy; without sleep complaints
Study of AK156 in Primary Osteoporosis Patients
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to investigate the efficacy and safety of AK156 in Japanese
      patients with primary osteoporosis.
    


Intervention name(s): AK156; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): zoledronic acid (i.v.)/year + daily calcium and vitamin D for 2 years; placebo (i.v.)/year + daily calcium and vitamin D for 2 years
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: AK156
Efficacy and Safety of Oral Lactobacillus Plantarum GUANKE (CGMCC NO.21720) in Enhancement of Antibody Level After SARS-CoV-2 Vaccination (Trial 1)
Condition: SARS-CoV-2
Study type: Interventional

Summary: 
      Preliminarily explore the effect of oral probiotics in SARS-CoV-2 serum neutralizing antibody
      titer level and T cell response level (spot formation cell counting).

      Provide a reference for determining the appropriate oral regimen. Provide necessary
      parameters for estimating the sample size of confirmatory clinical trial.
    

Detailed description: 
      In selected communities or assigned clinical trial institutions, participants who had
      completed two doses of SARS-CoV-2 vaccination will be invited in this study. Informed consent
      form will give to potential participants with well explained of trial contents during
      baseline. Participants who gave their signed informed consent form will be blocked randomized
      in a 1:1 ratio to intervention group or placebo control group.
    

Intervention name(s): Probiotics daily; Placebo daily
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Probiotics 1 time/day for 7 consecutive days; Placebo 1 time/day for 7 consecutive days
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A prospective, randomized, double-blind, placebo parallel controlled clinical trial.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Probiotic; lactobacillus plantarum
Use of Breath Acetone aa a Marker of Energy Balance
Condition: Fasting; Fed
Study type: Interventional

Summary: 
      This study aims at assessing whether breath acetone concentration is a good bio-marker of
      instantaneous energy balance in healthy subjects.
    

Detailed description: 
      Each participant will be studied on three occasions, separated by 1-4 weeks. Each evaluation
      will consist in the same set of metabolic measurements, but will be performed fasting or
      during administration of a 70% fat or 70% carbohydrate liquid diet, according to a randomized
      order.

      On each occasion, subjects will consume a standardized dinner the day before the experiment.
      They will remain fasted since 10 pm until the test day.

      On the day of the experiments, one venous cannula will be inserted into a forearm vein for
      the collection of blood samples. An indirect calorimetry (measurement of respiratory gas
      exchanges using a ventilated canopy at rest, or a face mask during exercise) will be
      performed throughout the 6-hour test to measure energy expenditure and net substrate
      oxidation rate. Blood samples will be obtained every 60 min for the measurement of plasma
      glucose, insulin, free fatty acids, and beta-hydroxybutyrate concentrations. Breath samples
      will be also collected every 60 min (in 500 ml sampling bag) for the measurement of breath
      acetone concentration using a novel gas analyzer based on infrared laser spectroscopy.

      Measurements will be done during 3 consecutive periods:

        -  0-120 min: Fast + Rest: subjects will remain lying in bed in fasting conditions
           (negative energy balance).

        -  120-360 min: Fed + Rest: subjects will remain in bed in a fasting state (C) or will
           receive every hour a liquid meal containing either 70% fat, 15% carbohydrate and 15%
           protein (Fat), or 70% carbohydrate, 15% fat and 15% protein (Sugar), corresponding to
           1.5 X hourly resting energy requirement (positive energy balance).

        -  360-480 min: Fed + Exercise: subjects will be transferred to an ergometric bicycle and
           will be asked to bike at a power output of 25 W [i.e. increasing total energy
           expenditure to ca. 2 time resting energy expenditure (negative energy balance)].
    

Intervention name(s): Fasting condition; Sugar condition; Fat condition
Intervention type(s): Other; Other; Other
Intervention description(s): Subjects will fast over the whole experimental period (480 min); After a 2-h fasting state, subjects will ingest every hour a drink containing 70% carbohydrate, 15% fat and 15% protein and providing 1.5 X hourly resting energy requirement.; After a 2-h fasting state, subjects will ingest every hour a drink containing 70% fat, 15% carbohydrate and 15% protein and providing 1.5 X hourly resting energy requirement.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: breath acetone; energy balance
Diagnostic Accuracy of Ultrasonography in Detecting Benign Radiolucent Lesions
Condition: Benign Radiolucent Lesions
Study type: Observational

Summary: 
      This is an in vivo study which aims to evaluate the diagnostic accuracy of ultrasonography in
      detecting benign radiolucent lesion in the both jaws. The ultrasonography-based diagnosis of
      contents will be compared to those findings obtained from the histological examination (i.e.
      the gold standard). The second part of this study will examine the measuring accuracy by
      comparing ultrasonography-based 3D measurements with those obtained from CBCT images of the
      lesion assuming that CBCT 3D measurements are the gold standard.
    

Detailed description: 
      Jaw is a common anatomical site for development of odontogenic and nonodontogenic lesions,
      and because of the wide variation of these lesions, the diagnosis is complex. Many techniques
      have been used to arrive at the final diagnosis such as conventional radiographs, computed
      tomography (CT), low dose cone beam CT, MRI.The use of ultrasonography has been shown to be
      important in evaluating the solid and cystic components of jaw lesions. Although ultrasound
      imaging technology is a safe and a minimally invasive procedure, and has been in use in
      medicine for many years, its use in dental medicine has been limited and mainly restricted to
      soft tissue applications. Studies evaluating the role of ultrasonography in the diagnosis of
      bone lesions of the jaw are limited.
    

Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Patients who are primarily diagnosed as having a benign lesion in one of the two jaws are
        going to be included in the study. Patients are usually referred to the Oral and
        Maxillofacial Department at our University Dental School to confirm their primary
        diagnosis. A database of these referred patients will be created and a random sample from
        this database will be withdrawn.
      
Keywords: CBCT; Ultrasonic diagnosis; Benign radiolucent lesions; Histopathology
Exploratory Bioavailability of Fentanyl Sublingual Spray Under Fasting Conditions
Condition: Bioavailability
Study type: Interventional

Summary: 
      The objective of this study is to compare the rate of absorption and bioavailability of
      fentanyl sublingual spray 400 mcg to fentanyl citrate 100 mcg by intramuscular injection.
    


Intervention name(s): Fentanyl Sublingual Spray (FSS); Fentanyl Citrate Injection (FCI); Naltrexone
Intervention type(s): Drug; Drug; Drug
Intervention description(s): A single dose of fentanyl, 400 mcg per sublingual spray; A single dose of fentanyl citrate, 100 mcg per intramuscular injection; Naltrexone is provided as a 50 mg tablet before and after product dosing to minimize unacceptable adverse effects of fentanyl.
Other intervention name(s): Subsys®
Intervention MeSH terms: Fentanyl; Naltrexone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Non-Invasive Neuromodulation in Children With Neurodevelopmental Disorders
Condition: Neurodevelopmental Disorders
MeSH terms: Neurodevelopmental Disorders
Study type: Interventional

Summary: 
      Children with neurodevelopmental disorders have a delay in acquiring the skills that are
      assumed considering the phases of typical psychomotor development. Added to this difficulty
      and main element of concern on the part of their families, there are another series of signs
      that appear with some frequency and that, despite being unnoticed against other major
      problems represent basic and fundamental factors in the correct development and performance
      such as constipation problems and sleep disorders.

      The aim of the study consists of to evaluate the effectiveness and safety of the non-invasive
      neuromodulation device applied in people with neurodevelopmental disorders, in relation to
      constipation problems and in the quality of sleep.
    

Detailed description: 
      While the application is being sent to the ethics committee, we will hold a series of
      informative talks for the centre's staff who, in one way or another, will be involved in the
      development of the project.

      At the same time, information letters will be sent to the parents or legal representatives of
      the children who will a priori be part of the project, as well as the corresponding informed
      consent. In addition, they will be sent the screening documents that will allow us to confirm
      if the selected subject has constipation problems and/or sleep disorders.

      The intervention period per subject will be 12 sessions, distributed in three sessions per
      week (Monday, Wednesday, and Friday), estimating that the intervention can be completed after
      one month.

      During school hours, the participants will receive their own treatment, agreed by their
      multidisciplinary team with common and personal objectives for the subjects, so that there
      will be no interruption of their usual routine.

      Two weeks after the intervention, a new assessment will be carried out to assess whether the
      possible changes recorded during the intervention phase have been maintained.
    

Intervention name(s): Non-invasive Neuromodulation
Intervention type(s): Device
Intervention description(s): The electrodes will be placed with the help of gloves and adapted socks for 1 hour, twice a week, until 12 intervention sessions are completed. In addition, depending on the session, an adhesive electrode will be placed at the level of C7. Characteristics of microcurrents: pulsed monophasic rectangular wave with a pulse of 1.3 s and pause of 300 ms, voltage 3 millivolt and intensity 0.5 μA.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: physical therapy modality; Electric Stimulation Therapy; Child Development Disorders
A Study to Assess Safety, Tolerability and Pharmacokinetics of GLPG2451 in Healthy Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is a Phase I, randomized, double-blind, placebo-controlled study evaluating
      multiple ascending oral doses of GLPG2451 and the combination of GLPG2451 and GLPG2222 given
      for 14 days in healthy male subjects.

      The purpose of the study is to evaluate the safety and tolerability of multiple ascending
      oral doses of GLPG2451 given to healthy male subjects compared to placebo, as well as of
      multiple oral doses of the combination of GLPG2451/GLPG2222 compared to placebo.
    


Intervention name(s): GLPG2451 multiple dose; Placebo multiple dose; GLPG2451/GLPG2222 multiple dose; Combined Placebo multiple dose
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): GLPG2451 oral suspension, multiple ascending doses, daily for 14 days; Placebo, oral suspension, daily for 14 days; GLPG2451 oral suspension and GLPG2222 oral suspension, multiple doses, daily for 14 days; Combined Placebo, oral suspension, daily for 14 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
A Study to Assess the PK of AL-794 Formulations in Healthy Subjects
Condition: Influenza
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a single-center, randomized, open-label crossover study to assess the
      pharmacokinetics and food effect of AL-794 formulations in healthy subjects.
    


Intervention name(s): AL-794 suspension; AL-794 tablet
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluating Safety of Andiabet on Diabetes Mellitus Type II Patients, Phase I CT.
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This phase I clinical trial is used to evaluate the safety of Andiabet, a herbal-derived
      medicinal product that assists in the treatment of type 2 Diabetes (T2D). Thereby, determine
      efficacy of the drug on stabilizing blood glucose in T2D patients.
    

Detailed description: 
      This is a 28-day phase I, open-label clinical trial to evaluate safety of Andiabet on . The
      general purpose is the evaluate safety via adverse events and tolerability of Andiabet on T2D
      patients, and evaluate effect of Andiabet on clinical and laboratory parameters.

      The study conducted on volunteering T2D patients, whose HbA1c level is =< 7.5% and are not
      pregnant, had no records of addiction, allergy, hypersensitivity, and chronic diseases. The
      main evaluation criteria are fasting glucose, used for evaluating efficacy and safety, which
      evaluated based on adverse events.

      Ensuring quality of the data:

      Sponsor and CRO are supervisors. Supervision will be conducted periodically, ensuring the
      compliance with the research proposal, following GCP.

      Hanoi Medical University-Clinical center of Pharmacology is responsible for managing the
      data. Completed CFR are sent to the Center of Clinical Pharmacology, entered by Microsoft
      Excel and analysed using SPSS 16.0 Before analysing, these data will be checked randomly,
      avoiding errors in data entry.
    

Intervention name(s): Andiabet
Intervention type(s): Drug
Intervention description(s): Each hard capsule includes: 200mg Gynostemma Pentaphyllum Leaf, 200mg Largerstroemia Speciosa Leaf, 133mg Anemarrhena Asphodeloides Whole
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 20 diabetes type 2 patients are recruited, in which 14 took part in the study, randomly divided into 2 arms.
Masking: None (Open Label)
Primary purpose: Treatment
Controlled Study of ONO-1101 in Patients With Postoperative Tachyarrhythmias in Japan
Condition: Postoperative Supraventricular Tachyarrythmia
MeSH terms: Tachycardia
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of ONO-1101 in postoperative
      supraventricular tachyarrhythmias.
    


Intervention name(s): ONO-1101
Intervention type(s): Drug
Intervention MeSH terms: Landiolol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: ONO-1101; Landiolol Hydrochloride; Postoperative; supraventricular tachyarrhythmia
Pre-study to Evaluate IENFD Induction in Patients With Taxane-induced CIPN
Condition: Peripheral Nervous System Diseases
MeSH terms: Nervous System Diseases; Peripheral Nervous System Diseases
Study type: Observational

Summary: 
      This is a non-interventional study examining IENFD levels in patients with CIPN after taxane
      chemotherapy and in age-matched healthy subjects.
    

Detailed description: 
      This is a non-interventional study examining IENFD levels in patients with CIPN after taxane
      chemotherapy and in age-matched healthy subjects. After the subjects sign the informed
      consent, the study physicians will judge the inclusion and exclusion criteria. Subjects
      meeting the inclusion requirements will register at the study center according to the
      requirements of the study physicians, and skin samples will be collected by specialized
      researchers.
    

Intervention name(s): Non interventional
Intervention type(s): Other
Intervention description(s): Non interventional
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        18-70 years old CIPN Patients and healthy subjects.