bioihbjkbjnl/mcl2 huggingface dataset:
Surgery Versus Non-surgical Treatment for Esophageal Squamous Cell Carcinoma in Patients Older Than 70 Years
Condition: Esophageal Squamous Cell Carcinoma; Esophagectomy; Radiotherapy; Chemotherapy
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Esophageal Squamous Cell Carcinoma
Study type: Observational [Patient Registry]

Summary: 
      To determine whether older patients who underwent esophagectomy had better outcome survival
      than those who were non-surgically treated.
    


Intervention name(s): Since the data were collected retrospectively, there were no interventions
Intervention type(s): Diagnostic Test
Intervention description(s): Since the data were collected retrospectively, there were no interventions
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Data were obtained from the Sichuan Cancer Hospital & Institute Esophageal Cancer Case
        Management and the department of radiation oncology multicenter databases. We
        retrospectively analyzed esophageal squamous cell carcinoma patients who were 70 years or
        older, who underwent esophagectomy or radiotherapy/chemotherapy from January 2009 to
        December 2017. Patients were divided into two groups: surgery and non-surgery groups. We
        then prospectively collected data on 284 patients with esophageal squamous cell carcinoma
        in the Sichuan Cancer Hospital for results verification.
Study to Test Software Algorithm for Insulin Therapy and New Glucose Sensor
Condition: Diabetes
Study type: Interventional

Summary: 
      To investigate the performance of a software-algorithm based insulin therapy to control blood
      glucose in Type 1 diabetic patients.
    


Intervention name(s): algorithm
Intervention type(s): Procedure
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Pain Control Using Neuromodulation in Patients Undergoing Definitive Chemoradiotherapy for Head and Neck Cancer
Condition: Cancer of Head and Neck
MeSH terms: Head and Neck Neoplasms
Study type: Interventional

Summary: 
      The purpose of this study is to determine if Transcranial Direct Current Stimulation (tDCS)
      can reduce pain perception associated with the effects of receiving definitive radiation
      therapy or chemoradiotherapy in head and neck cancer (HNCa) patients.
    

Detailed description: 
      The goal of this study is to investigate the effectiveness of tDCS as a novel pain relief
      modality for odynophagia due to mucositis in patients with locally advanced head and neck
      cancer undergoing definitive radiation therapy or chemoradiotherapy. Participants will be
      randomized into one of two arms: (1) Treatment: radiation/chemoradiotherapy standard of care
      + tDCS neuromodulation or (2) Control: radiation/chemoradiotherapy standard of care only.

      Patients in the treatment arm will undergo tDCS stimulation on the day of their
      radiation/chemoradiotherapy appointments, prior to receiving treatment when doing tDCS
      session in clinic or after to receiving treatment when doing tDCS session at home. This will
      occur daily (5 days per week) during the second and third weeks of therapy, three times per
      week during the fourth and fifth weeks, and twice per week during the sixth and seventh
      weeks.

      Patients will also have EEG and fNIRS recordings during the study. This will occur at the
      pre-study visit, the first stimulation appointment, the third week, the 7th week, and during
      the follow-up appointments (one-week and one-month).
    

Intervention name(s): Transcranial Direct Current Stimulation (tDCS)
Intervention type(s): Device
Intervention description(s): tDCS is a non-invasive brain neuromodulatory method that involves sending a weak electrical current to the brain. 2mA of tDCS will be applied for 20 minutes at each session and participants will undergo a total of 20 sessions over a 7-week period.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Cancer Pain; EEG; fNIRS; tDCS
A Study to Evaluate the Pharmacokinetics and Safety Between Single Administration of "BR6002" and Coadministration of "BR6002A" and "BR6002B" Under Fed Conditions in Healthy Adult Volunteers
Condition: Gastric or Duodenal Ulcer
MeSH terms: Duodenal Ulcer
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this clinical trial is evaluate the pharmacokinetics and safety between single
      administration of "BR6002" and coadministration of "BR6002A" and "BR6002B" under fed
      conditions in healthy adult volunteers
    


Intervention name(s): BR6002A; BR6002B; BR6002
Intervention type(s): Drug; Drug; Drug
Intervention description(s): One tablet administered alone; One tablet administered alone; One capsule administered alone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Motiv82Change: an HIV Prevention Study for Young Latino Men
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional

Summary: 
      The purpose of this study is to develop and pilot test a culturally and developmentally
      tailored Motivational Enhancement Intervention (MEI) to reduce risky sex (unprotected anal
      sex and multiple partners) among young Hispanic men who have sex with men (YHMSM).
    

Detailed description: 
      Stage 1, divided into Stage 1a and Stage 1b, focuses on development, refinement, and pilot
      testing of interventions. The formative research leading to and including intervention
      development is completed in Stage 1a. A pilot study to provide acceptability/feasibility data
      and obtain effect size estimates of the intervention's strength in changing a desired outcome
      is conducted in Stage 1b. If Stage 1b results are "promising," the intervention moves to full
      scale efficacy testing in Stage 2 using the classic experimental design of a randomized
      control trial (RCT). The intervention is ready for Stage 3 effectiveness testing only after
      its efficacy has been demonstrated in at least two Stage 2 trials.
    

Intervention name(s): Entre Culturas: Navigating Culture, Identity, and HIV Risk
Intervention type(s): Behavioral
Intervention description(s): A pilot test of a culturally and developmentally tailored MEI to reduce risky sex (unprotected anal sex and multiple partners) among young Hispanic men who have sex with men (YHMSM) to be delivered face-to-face (FtF) and through the Internet using a real-time implementation approach. A tailored MEI for two delivery modalities, and a health education control (HEALTH) comparable in time and number of sessions. We will test the MEI's acceptability and feasibility, obtain effect size estimates of the intervention's strength to reduce risky sex, and determine if it is ready for efficacy testing.
Other intervention name(s): Young Hispanic MSM; HIV prevention interventions; Motiv8 2Change
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: HIV; HIV Seronegativity; prevention; Hispanic; Latino; MSM; men
Coarctation Of the Aorta Stent Trial
Condition: Coarctation of the Aorta
MeSH terms: Aortic Coarctation
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether Cheatham Platinum bare metal stents are
      safe and effective in the treatment of native and recurrent aortic coarctation in selected
      children, adolescents and adults.
    

Detailed description: 
      The goals of this study are to provide information that will support labeling of both the CP
      bare metal and covered stents to treat native and recurrent aortic coarctation in selected
      children, adolescents and adults. The investigation will have two phases: Phase One will
      examine the safety and efficacy of the bare metal stent, and will collect information about
      the covered stent when used as rescue therapy for aortic injuries occurring during bare metal
      stent procedures.

      The aims of the Phase One study are to assess the use of the CP bare metal stent to:

        1. provide a reduction equivalent to surgery in arm-leg systolic cuff blood pressure
           gradient 12 months after dilation and stent implantation, in comparison to the
           pre-dilation gradient;

        2. accomplish gradient relief with a shorter number of days in hospital than surgery;

        3. accomplish gradient relief with a rate of occurrence of serious procedure-related
           adverse events occurring within 30 days of dilation that is equivalent to surgery; and

        4. accomplish gradient relief with a rate of occurrence of post-procedural paradoxical
           hypertension that is lower than surgery.
    

Intervention name(s): Stent therapy of aortic coarctation
Intervention type(s): Device
Intervention description(s): Transcatheter delivery of a metallic stent to enlarge region of aortic narrowing caused by the coarctation.
Other intervention name(s): Cheatham-Platinum Stent
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Aortic Coarctation; Heart Defects, Congenital; Stents; Heart Catheterization
Mineral Water Rich in Magnesium and Perceived Stress in Healthy Consumers
Condition: Magnesium Deficiency; Stress, Psychological
MeSH terms: Magnesium Deficiency; Stress, Psychological
Study type: Interventional

Summary: 
      The goal of clinical trial is to evaluate the effect of one month of consumption of mineral
      water rich in magnesium or not on perceived stress, duration and quality of sleep in healthy
      consumers having magnesium daily intakes below the recommended dietary allowance (RDA).
    

Detailed description: 
      This is a single-center, double-blind, controlled, randomized, 2 parallel-groups clinical
      trial.

      256 healthy volunteers will be recruited for clinical trial if they meet the inclusion and no
      inclusion criteria.

      50% of volunteers (Mg+ group) will drink daily 1,5 L of mineral water rich in magnesium
      during 30 days

      50% of volunteers (Mg- group) will drink daily 1,5 L of water low in magnesium during 30 days

      Volunteers in both groups will be equipped with a wristband-connected device allowing
      recording of duration and quality of sleep.
    

Intervention name(s): Mg(+); Mg(-)
Intervention type(s): Other; Other
Intervention description(s): 1,5 L per day during 30 days
No livestyle counseling; 1,5 L water per day during 30 days No lifestyle counseling
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: magnesium deficiency; stress psycological; sleep duration and quality; mineral water rich in magnesium
Risk Factors Associated With Binge Drinking Behaviors Among College Students
Condition: Binge Drinking
MeSH terms: Binge Drinking
Study type: Interventional

Summary: 
      The purpose of this study is to specify the psychological, cognitive, neuro-functional and
      genetic profile associated with binge drinker behaviors among young adults. Results will help
      identifying more precisely vulnerability factors associated with this pattern of alcohol
      consumption and guiding prevention efforts.
    

Detailed description: 
      Binge drinking behavior is characterised by speed of drinking on a particular occasion,
      frequency of drunkenness during the most recent six month period, and the percentage of times
      getting drunk when drinking. The prevalence of weekly binge drinking among European Union
      drinkers in 2009 was reported to be 28% of the student population, and 33% among all young
      people aged 15-24. The consequences of this behavior are multiple and often dramatic, they
      include: academic failure, violent acts, rape, domestic or road accidents. The study aims to
      identify vulnerability factors associated with binge drinking. The protocol explores the
      psychological (personality), neuropsychological (executive functions, memory), genetic (snp
      polymorphisms) and neuro-anatomical (fMRI) patterns associated with binge drinking behavior.
    

Intervention name(s): Alcoolpredict
Intervention type(s): Other
Intervention description(s): psychological (personality), neuropsychological (executive functions, memory), genetic (snp polymorphisms) and neuro-anatomical (fMRI)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Resolution of Liver Fat in Non-alcoholic Fatty Liver Disease
Condition: NAFLD
MeSH terms: Liver Diseases; Fatty Liver
Study type: Interventional

Summary: 
      The major adverse health consequences of obesity occur only when non-alcoholic fatty liver
      disease (NAFLD) also develops. NAFLD is characterized by abnormal hepatic accumulation of
      triglycerides and other lipids. The first-line approach to NAFLD management is caloric
      restriction and weight loss, but these remain difficult to achieve. Little attention has been
      given to dietary carbohydrate restriction, despite recent reports showing that hepatic de
      novo lipogenesis, a process that converts dietary carbohydrates into fatty acids in the
      postprandial state, accounts for approximately 25% of liver triglyceride content in
      hyperinsulinemic subjects with NAFLD. For comparison, only 15% of the liver triglycerides
      were derived from dietary fatty acids in patients with NAFLD who had consumed a standardized
      30% fat diet for four days before being assessed.
    

Detailed description: 
      To establish the time-course of hepatic fat loss in NAFLD subjects on a
      carbohydrate-restricted diet (<20 g/day), a serial assessments of liver fat during two week
      diet will be performed. Also, markers of lipid and insulin metabolism, liver function test
      and changes in gut microbiota during rapid metabolic improvement will be assessed.

      The overall aim is to exploit this unique set of human material to determine the specific
      cellular and molecular pathways that are modified in the early stages of metabolic
      improvement and fatty liver regression.
    

Intervention name(s): Low carbohydrate diet
Intervention type(s): Other
Intervention description(s): Isocaloric, carbohydrate restricted diet 14 days
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Prevalence of Incontinence and Risk Factors in Children With Cerebral Palsy
Condition: Urinary Incontinence
MeSH terms: Cerebral Palsy; Urinary Incontinence; Enuresis
Study type: Observational

Summary: 
      This study evaluates (risk)factors influencing (in)continence in children with and without a
      brain injury.
    

Detailed description: 
      Children with cerebral palsy (CP) (Rosenbaum, 2007) gain bladder and bowel control at older
      age compared to typical developing children (Ozturk, 2006). The incidence of urinary
      incontinence during day and night, fecal incontinence and constipation is higher in this
      population.

      Incontinence in children is often treated with urotherapy. This is a nonsurgical,
      nonpharmacological treatment for lower urinary tract dysfunctions. Standard urotherapy is
      noninterventional and it includes giving information, instructions, advice regarding
      life-style, fluid intake and bladder diaries. Additionally specific interventions can be
      used, such as: various forms of pelvic floor training, behavioral modification, biofeedback,
      electrical stimulation and catheterization (Neveus, 2006). Recent research has proven
      urotherapy to be successful for the treatment of children with daytime incontinence (Mulders,
      2010).

      Despite the high prevalence of incontinence in children with CP the possible treatment
      strategies in this population are poorly investigated. Far too often, urinary incontinence in
      children with CP is considered a normal, unavoidable and even a minor problem.

      Aim: Analyze (risk) factors influencing (in)continence in children with and without CP.

      Possible parameters will be registered through questioning, measurement (uroflow combined
      with pelvic floor EMG and postmictional residue) and retrospective analysis of the patient
      files. Parameters will be compared between continent and incontinent children with and
      without CP. This comparison evaluates whether the same therapeutic strategies can be applied
      in incontinent children with and without CP.
    

Intervention name(s): Questionnaire and micturition and drinking diaries; Uroflowmetry, pelvic floor EMG and bladderscan
Intervention type(s): Other; Procedure
Intervention description(s): Questionnaire: ICCS parental questionnaire + extended history taking document, ROME III criteria, demographic information and/or PIN-Q.
Diaries: 24-hour voiding chart; Voiding variables, pelvic floor activity during micturition and postmictional residue.
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Children with CP: Cerebral palsy Reference Centre (Ghent university hospital) Incontinent
        children with normal development: Urology department (Ghent university hospital) continent
        children with normal development: community sample
      
Keywords: Cerebral Palsy; Risk factors; Child; urinary incontinence
Patient Recovery From Heart Surgery During the Covid-19 Pandemic
Condition: Cardiac Surgery; COVID
MeSH terms: COVID-19
Study type: Observational

Summary: 
      This study will describe and explore the recovery process of patients undergoing cardiac
      surgery during the covid-19 pandemic. This will include mortality, morbidity, health-related
      quality of life, event-specific distress and depression.
    

Detailed description: 
      The overall aim of this study is to describe and explore the recovery process of patients
      undergoing cardiac surgery during the covid-19 pandemic. This will include mortality,
      morbidity, health-related quality of life, event-specific distress and depression.

      All adult patients having cardiac surgery during the pandemic at St Bartholomew's Hospital
      will be approached to join this study. As of the end of March this is this is approximately
      20 operations a week. Questionnaires will be administered at five time points alongside a
      review of clinical notes.

      Appropriate descriptive and summative statistics will be used to analyse outcomes. If sample
      size is adequate, possible associations/effect of the impact of the covid-19 pandemic on each
      of the recovery parameters included in the study will be determined. The differences in
      outcomes between those with and without covid-19 may also be analysed if the sample size is
      adequate. Bias and loss to follow-up in observational cohort studies has been considered.
    

Intervention name(s): Cardiac surgery
Intervention type(s): Other
Intervention description(s): Cardiac surgery during the COVID-19 pandemic
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adult patients undergoing cardiac surgery during the COVID-19 pandemic
      
Keywords: cardiac surgery; patient reported outcomes; COVID
Sole Local Anesthetic Versus Opioid Plus Local Anesthesia in Epidural Labor Analgesia
Condition: Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      It is common for obstetric anesthesia using opioid supplement to local anesthetics for
      epidural labor pain control. Given the low doses of these epidural drugs, we never doubt the
      necessity of the supplement of opioid to lacal anesthetics during this process based on the
      concept that opioid addition can enhance and prolong the analgesic effect of local
      anesthetics. However, we unavoidably encounter many opioid-associated side effects during the
      labor delivery. In addition, usage of opioid increase the medical cost for each patient. We
      herein hypothesized that in the context of obstetric anesthesia, sole local anesthetics can
      produce as the same analgsic effect as opioid plus local anesthetics given for epidural labor
      pain control.
    


Intervention name(s): Sole local anesthetic; Sufentanil (Opioid plus local anesthetic); Ropivacaine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 0.125% ropivacaine 10-15 ml every 1h during labor delivery; Sufentanil combined with 0.125% ropivacaine, 10-15 ml every 1h during labor delivery
Other intervention name(s): Ropivacaine; Naropin; Naropin
Intervention MeSH terms: Sufentanil; Ropivacaine; Anesthetics, Local; Anesthetics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Opioid; Local anesthetic; Labor delivery; Safety
Effects of Different Recovery Methods on Lactic Acid Removal, Flexibility, Strength, and Endurance
Condition: Recovery Methods; Exercise Training
Study type: Interventional

Summary: 
      The aim of this study is to compare these three different recovery methods following a single
      bout high-intensity interval exercise program with each other in terms of blood lactate
      clearance, muscle flexibility, muscle strength and endurance.
    

Detailed description: 
      It is very important to choose the most effective recovery method for the athletes in
      training for their next training/competition. The recovery period is very significant in
      terms of removal of blood lactate and body dynamics as soon as they return to their original
      state and achieve high performance. Neither neuromuscular electrical stimulation,
      low-intensity aerobic exercise, self-massage with foam roller methods, which have been proven
      their effectiveness in the literature, have been compared with each other.
    

Intervention name(s): Active Recovery Group; Self-Massage with Foam Roller Group; Neuromuscular Electrical Stimulation
Intervention type(s): Other; Other; Other
Intervention description(s): Participants in this group will exercise for 15 minutes, for a range of 65 to 70% of the maximum heart rate as a recovery method following a single bout high-intensity interval exercise program; This group will perform 15 minutes self-massage with foam roller following the exercise session as a recovery method following a single bout high-intensity interval exercise program.; Participants of this group will be applied electrical stimulation on quadriceps femoris and hamstring muscles for 15 minutes while they are comfortable lying position as a recovery method following a single bout high-intensity interval exercise program.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: neuromuscular electrical stimulation, low intensity aerobic exercise, self massage with foam roller methods
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: foam roller; electrical stimulation; low intensity aerobic training; lactate removal