bioihbjkbjnl/mcl2 huggingface dataset:
Mesh Alone VS Combined Mesh and Darn in the Management of Primary Inguinal Hernia in Adult Males
Condition: Inguinal Hernia
MeSH terms: Hernia; Hernia, Inguinal
Study type: Interventional

Summary: 
      A prospective randomized study involved 228 individuals with primary inguinal hernia,
      operated in our departments, between January 2015 to February 2018. The duration of hospital
      stay, operative time, duration of returning to routine activities, postsurgical sequels and
      recurrence rates estimated. We randomly allocated it into two groups: mesh repair was applied
      to 166 patients (Group 1) and combined both mesh, and darn repair applied to 162 patients
      (Group 2).
    

Detailed description: 
      Background In spite of the era of laparoscopy still, open repair in primary inguinal hernia
      is currently the most commonly performed general surgical operation. To evaluate whether the
      combined darn repair plus Lichtenstein compare Lichtenstein repair alone in the treatment of
      inguinal hernias regarding postoperative complication and recurrence.

      Materials and methods:

      A prospective randomized study involved with 218 patients with primary inguinal hernia,
      operated in our departments, between 2015 and 2018. The duration of the operation time,
      hospitalization, and time to return to daily activities and postoperative complication and
      recurrence rates were evaluated. We randomly allocated into two groups: Lichtenstein repair
      was applied to 169 patients (Group 1), and combined both modified darn repair plus
      Lichtenstein repair was applied to 160 patients (Group 2).

      Results:

      The average follow-up period was 48 months. For the alone Lichtenstein procedure, the average
      duration of operation was 62 min; the average time to return to routine activities was 21
      days. The number of patients with postoperative complications was 12 (11.3 %), and the number
      of patients with recurrence was 1 (0. 9%). For darn repair plus Lichtenstein procedure, the
      average duration of operation was 72 min; the time to return to daily activities was 21days.
      The number of patients with postoperative complication was 13 (11.6%), and no recurrences
      were noted. The hospitalization time of the groups was similar.

      Conclusion:

      Two-year follow-up, combined mesh and darn better than mesh alone in recurrence rate, both
      had the same postoperative complication, hospitalization time and return to routine activity.
    

Intervention name(s): polypropelene mesh
Intervention type(s): Procedure
Intervention description(s): compare use mesh alone or combined mesh and darn repair
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Adult inguinal hernia; Mesh; Darn repair; Hernia repair techinques; Primary inguinal hernia
Open Thyroid Surgery With Pillow Versus no Pillow for Better Post-operative Outcomes
Condition: Post-operative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      Primary: To compare the post-operative pain in patients with neck extension and without neck
      extension.

      Secondary: To determine the benefit of neck exposure and peri-operative complications, which
      include duration of operation, intra-operative blood loss, recurrent nerve (RLN) injury and
      hypocalcaemia in both groups.

      Hypothesis: Patients who undergoing thyroidectomy without neck extension will have less
      post-operative pain and there are no significant difference of post-operation complications
      between both groups.
    

Detailed description: 
      Conventional open thyroid surgery is still one of the most common operations performed
      globally. Traditionally, patients who undergoing thyroid surgeries are usually positioned
      with extended neck by using pillow under shoulder in order to facilitate neck exposure and
      make the surgery easier. However, the degree of benefit from the extended neck is doubtful
      and there is little objective evidence that suggest extended neck thyroid surgery offers
      better outcomes. On the the hand, over-extension of the neck should be avoided because of it
      is associated with post-operative pain, vomiting, spinal damage and stroke. The objective of
      the present study is to compare the post-operative pain in patients with neck extension and
      without neck extension. In addition to that, we also like to determine the benefit of neck
      exposure and peri-operative complications, which include duration of operation,
      intra-operative blood loss, recurrent nerve (RLN) injury and hypocalcaemia in both groups.
      This is a prospective randomized controlled trial, which will be conducted from 1st of March
      2012 till 30th September 2012. Given that approximately 300 to 400 patients would undergo
      thyroid surgery in each year, we estimated 180 patients will be recruited and randomly
      divided into 2 groups (neck extension and no neck extension) before undergoing open thyroid
      surgery for this trial. Visual analogue scale (VAS) is used to determine the post-operative
      pain. Primary end point and other peri-operative variables are then analyzed with SPSS
      software.
    

Intervention name(s): Extended neck with standard support or pillow
Intervention type(s): Procedure
Intervention description(s): Patient will undergo thyroid surgery with an extended neck
Other intervention name(s): neck extension; neck hyper-extension
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Post-operative pain; Wound bleeding requiring exploration; PTH; RLN complication; Hypocalcaemia complication
Testing the Effectiveness of Integrating Relationship Education Into an Existing Workforce Readiness Program
Condition: Marriage; Family Relations
Study type: Interventional

Summary: 
      The project will test the strategy of integrating 25 hours of relationship education into an
      existing employment program for low-income individuals ages 18-30. It will use a 2-arm
      randomized controlled trial to test the effect of this full package of services on
      participants' employment outcomes and relationship outcomes.
    

Detailed description: 
      The study will examine the programming by FWCA, which currently offers the Career Pathways
      Bridge program in three locations in St. Louis County in Missouri. The evaluation will test
      the strategy of integrating relationship education into an existing workforce readiness
      program. FWCA plans to add approximately 17 hours of content from the Within My Reach
      relationship education curriculum to the two-week job readiness workshop it offers as part of
      the Career Pathways Bridge program. Second, FWCA will add up to eight additional one-hour
      relationship skills education sessions that customers can attend in the five weeks after
      completing the initial two-week job readiness workshop.

      The evaluation will use a 2-arm randomized controlled trial to test the effect of this full
      package of services on participants' employment outcomes and relationship outcomes. The
      target population will be low-income individuals ages 18-30 living in St. Louis County,
      Missouri. The study will aim to enroll 1000 individuals over 2 years. The Metropolitan
      Employment and Training (MET) Center will be the primary recruitment and service location.
    

Intervention name(s): Workforce Readiness Program; Relationship education
Intervention type(s): Behavioral; Behavioral
Intervention description(s): job readiness workshops, organized into ten daily sessions over two weeks.; 25-hours of "Within My Reach" curriculum and relationship skills education sessions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Cognitive Behavioral Therapy for Adolescent Binge Eating and Loss of Control Eating
Condition: Binge Eating; Eating Disorders in Adolescence; Overweight and Obesity
MeSH terms: Overweight; Bulimia; Feeding and Eating Disorders; Binge-Eating Disorder
Study type: Interventional

Summary: 
      This study will develop and test a cognitive-behavioral intervention for adolescents with
      binge/loss-of-control eating.
    

Detailed description: 
      Youth who engage in binge eating or loss-of-control eating are at high risk for physical and
      mental health impairment, as well as excess weight gain. As there are few evidence-based
      treatments for adolescents with binge/loss-of-control eating, assessment and treatment have
      received minimal attention for adolescent patients. Among adults, cognitive-behavioral
      therapy (CBT) has a strong evidence base for binge-eating disorder. Adolescents have unique
      social, cognitive and emotional needs because of their developmental stage; unique treatment
      approaches are essential to meet these unique needs. This study will develop a new CBT
      treatment for adolescents with binge eating or loss-of-control eating (modifying adult CBT
      for binge-eating disorder, conducting interviews with adolescents about aspects of treatment
      that need to be modified, conducting an open series of patients who receive the active
      treatment). This study will also test the efficacy of the newly-developed CBT for adolescents
      with binge/loss-of-control eating versus a control group in a randomized controlled trial.
    

Intervention name(s): Cognitive-Behavioral Therapy for Adolescent Binge/Loss-of-Control Eating; Control Condition
Intervention type(s): Behavioral; Other
Intervention description(s): Cognitive-behavioral therapy (CBT) developed for adolescents with binge eating or loss-of-control eating.; Educational and informational materials on adolescent health and nutrition.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: adolescent; cognitive-behavioral therapy; loss of control eating
Effects of Isoflavones on Gene-expression
Condition: Postmenopause
Study type: Interventional

Summary: 
      Alleged benefits experienced by the consumption of soy in Asian countries have been
      attributed to the isoflavone content of soy products. Amongst other benefits, isoflavones are
      believed to relieve menopausal symptoms and are therefore often consumed in supplement form
      in Western countries. These supplements contain relatively high amounts of isoflavones, and
      the question is if these concentrations still exert beneficial effects or whether negative
      effects become dominant. Therefore, the investigators will study the effect of intake of one
      dose of isoflavones, as compared to placebo, for eight weeks on gene-expression in Peripheral
      Blood Mononuclear Cells (PBMCs) in post-menopausal, equol-producing women.
    

Detailed description: 
      Primary Objective: to determine the effect of intake of one dose of isoflavones, as compared
      to placebo, for eight weeks on gene-expression in Peripheral Blood Mononuclear Cells (PBMCs)
      in post-menopausal, equol-producing women.

      Secondary Objectives: to determine the association between isoflavone plasma levels and
      gene-expression in PBMCs; to determine the variation of isoflavone plasma levels between
      subjects after intake of isoflavones for four and eight weeks; to explore whether PBMC
      gene-expression markers identified after 8 weeks isoflavone intervention are already present
      after 4 weeks intervention; to explore whether the severity of previous menopausal complaints
      is related to the effect of isoflavones on PBMC gene-expression; and to explore the
      association between isoflavone levels in plasma and spot urine.

      Study design: Double-blind placebo controlled crossover intervention study

      Study population: Thirty-six healthy females, 45-70 years, post-menopausal and
      equol-producing

      Intervention: Two intervention periods of eight weeks with a isoflavone supplement or a
      placebo and a washout period of 8 weeks in between.

      Main study parameters/endpoints: The main study parameter is gene-expression in PBMCs
      measured by micro-arrays.
    

Intervention name(s): Isoflavone supplement
Intervention type(s): Dietary Supplement
Intervention description(s): The participants will consume 2 times 2 supplements per day, which will lead to a daily dose of 114 mg. (HPLC analysis confirmed an aglycone isoflavone content of 28.41 mg per supplement)
Other intervention name(s): Phytosoya forte (35mg) from the company Arkopharma
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Keywords: health; women
PK Study of Dapagliflozin in Pediatric Subjects With T2DM
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of this study is to evaluate the pharmacokinetics (PK) of Dapagliflozin
      in pediatric subjects with type 2 diabetes mellitus (T2DM)
    

Detailed description: 
      Primary purpose: The primary purpose is to assess the pharmacokinetics of a single dose of
      Dapagliflozin in the range of 2.5 to 10 mg in pediatric subjects aged 10 to 17 years with
      T2DM
    

Intervention name(s): Dapagliflozin; Dapagliflozin; Dapagliflozin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Tablet, Oral, 2.5 mg, Single-dose; Tablet, Oral, 5 mg, Single-dose; Tablet, Oral, 10 mg, Single-dose
Intervention MeSH terms: Dapagliflozin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Symptomatic Treatment of Acute Uncomplicated Diverticulitis
Condition: Diverticulitis
MeSH terms: Diverticulitis
Study type: Interventional

Summary: 
      The purpose of this study is to determine the safety and efficacy of symptomatic treatment
      (i.e. without antimicrobial drugs) of acute uncomplicated diverticulitis.
    


Intervention name(s): Ibuprofen; Paracetamol
Intervention type(s): Drug; Drug
Intervention MeSH terms: Acetaminophen; Ibuprofen
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Resistant Wheat Starch on Subjective Appetite and Food Intake in Healthy Adults
Condition: Feeding Behavior
Study type: Interventional

Summary: 
      A randomized, single-blind, cross-over study was conducted to determine the effect of
      replacing standard wheat flour (SWF) with resistant wheat starch (RWS) on markers of appetite
      and food intake in healthy adults.
    


Intervention name(s): Resistant Starch Type 4
Intervention type(s): Dietary Supplement
Intervention description(s): single dose 26g fiber given at the breakfast meal
Other intervention name(s): Fibersym
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Keywords: Appetite; Food Intake; Satiety Hormones
A Study to Evaluate the Efficacy and Safety of Experimental Drugs ABT- 493/ABT-530 in Adults With Chronic Hepatitis C Virus Genotype 1-6 Infection and Human Immunodeficiency Virus -1 Coinfection (EXPEDITION-2)
Condition: Hepatitis C Virus Infection; Human Immunodeficiency Virus Infection; Chronic Hepatitis C; Compensated Cirrhosis and Non-cirrhotics
MeSH terms: Infections; Communicable Diseases; Hepatitis A; Virus Diseases; Hepatitis C; Hepatitis C, Chronic; Acquired Immunodeficiency Syndrome; HIV Infections; Hepatitis; Hepatitis, Chronic; Immunologic Deficiency Syndromes; Fibrosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess the efficacy and safety of ABT-493/ABT-530 in adults
      with chronic hepatitis C virus genotype 1-6 infection and human immunodeficiency virus-1
      co-infection.
    


Intervention name(s): ABT-493 coformulated with ABT-530
Intervention type(s): Drug
Intervention description(s): Tablet
Other intervention name(s): ABT-493 also known as glecaprevir; ABT-530 also known as pibrentasvir; MAVYRET
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HCV Genotype 3; Non-cirrhotic; HCV Genotype 1; HCV Genotype 6; Human Immunodeficiency Virus (HIV) Infection; HCV Genotype 5; HCV Treatment Naive; HCV Genotype 4; HCV Treatment Experienced; HCV Genotype 2; Hepatitis C Virus (HCV) Infection; Compensated Cirrhosis
Correlation of Risk Factors and Severity of Hypoxic-ischaemic Encephalopathy
Condition: Hypoxic Ischaemic Encephalopathy
MeSH terms: Brain Diseases; Brain Ischemia; Hypoxia-Ischemia, Brain; Ischemia; Hypoxia
Study type: Observational

Summary: 
      The first aim of this study is to analyse perinatal risk factors leading to hypoxic ischaemic
      encephalopathy in term and near term neonates born in Switzerland who were admitted to the
      neonatal and intensive care units offering hypothermia therapy.

      Further, investigators would like to analyse the influence of these perinatal risk factors on
      the severity of encephalopathy during and after hypothermia therapy.
    

Detailed description: 
      Encephalopathy of the neonate could have different aetiologies. Perinatal asphyxia leading to
      hypoxia-ischaemia is frequent ,1-2 per 1000 life born neonates are affected. Hypoxic
      ischaemic encephalopathy is one of the most important causes for adverse neurodevelopmental
      outcome, cerebral palsy, epilepsy and hearing and vision deficiencies in term and near term
      neonates. Til now, hypothermia therapy is the only therapy reducing the risk of adverse
      neurodevelopmental outcome and is nowadays standard of care. In this study investigators
      would like to analyse perinatal risk factors causing HIE and their influence on the Sarnat
      Score on day 1 and 3 of life (during hypothermia therapy) and on day 4 of life (after
      hypothermia therapy).
    

Intervention name(s): risk factors
Intervention type(s): Other
Intervention description(s): investigators will analyze if certain risk factors will influence the progression of the encephalopathy
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Neonates born >35 0/7 gestational weeks with clinical signs of hypoxic encephalopathy with
        Apgar Score<5 with 10minutes of life, mechanical ventilation with 10minutes of life, pH 7.0
        or BE -16mmol/L, lactate >12mmol/L within 60minutes after birth, and seizures or Sarnat
        staging II-III or Thompson Score >7.
      
Keywords: hypothermia therapy; perinatal asphyxia
Assessment of Thoracolumbar Fascia Length
Condition: Fascia
MeSH terms: Shoulder Impingement Syndrome
Study type: Observational

Summary: 
      The purpose of the study is to compare the elasticity of thoracolumbar fascia in patients
      with and without subacromial impingement syndrome.

      30 patients diagnosed as subacromial impingement syndrome in physical medicine and
      rehabilitation department of Baskent University will be recruited as group 1. 30 healthy
      volunteers will be recruited as group 2. Visual Analogue Scale (VAS) with the aim of
      assessing pain severity, tape measurement for posterior capsule shortness; body lateral
      flexion, rotation and extensor movements and lumbar extensor shortness will be observed for
      correlation with thoracalumbal fascia flexibility. Lateral flexion, flexion, and extension
      movements will be measured using goniometry for trunk normal joint movements. The
      thoracolumbar fascia length test and Modify Schober test will be used for thoracolumbar
      fascia length.
    


Intervention name(s): Visual Analogue Scale; posterior capsule tightness; shortness tests for lumbar movements; range of motion tests for lumbar movements; The thoracolumbar fascia length test; Modify Schober test
Intervention type(s): Diagnostic Test; Diagnostic Test; Diagnostic Test; Diagnostic Test; Diagnostic Test; Diagnostic Test
Intervention description(s): intensity of pain perception patients feel; tape measurement for posterior capsule tightness with patients lying at side and horizontally adducting their shoulder.; tape measurement for lumbar movements; range of motion measurements for lumbar flexion, extension and lateral flexion with goniometer.; patient sitting straight with shoulders at horizontal plane, both the arms are asked to rotated with primarily spinal rotation. the degree of rotation gives idea about the thoracolumbar fascia length; tape measurement of spinal flexion between designated regions
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        30 patients with Subacromial Impingement Syndrome and 30 volunteers
      
Keywords: thoracolumbar fascia; subacromial impingement syndrome
WalkIT Arizona: Walking Interventions Through Texting
Condition: Physical Activity; Behavior; Goals
Study type: Interventional

Summary: 
      The purpose of this study is to develop adaptive (AI) and micro-incentive (MI) interventions
      and test them against static (SI) and delayed-incentive (DI) interventions in a 4-arm
      randomized factorial trial to increase MVPA adoption and maintenance among inactive adults.
      Using neighborhood walkability and socioeconomic status, participants will be recruited from
      four neighborhood types: "high walkable/high SES," "high walkable/low SES," "low
      walkable/high SES," and "low walkable/low SES." We will evaluate synergistic or antagonistic
      effects of interventions and neighborhood factors on MVPA adoption by 12 months and
      maintenance by 24 months.
    


Intervention name(s): Adaptive Goals; Static Goals; Delayed (non-contingent) Incentives; Immediate Micro-Incentives
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): Prescribed goals change daily based on participant's performance; Prescribed goals remain the same throughout study; Incentives are provided on bi-monthly basis for participation; Incentives are provided immediately for each goal attained
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Reinforcement; Walking; Exercise; Built Environment; Adaptive; Financial incentive; Walkability
The Effect of Obturator Thickness on the Function
Condition: Maxilla--Cancer
Study type: Interventional

Summary: 
      the effect of obturator bulb thickness on masticatory function has been verified.
    


Intervention name(s): obturator
Intervention type(s): Device
Intervention description(s): variable bulbs
Other intervention name(s): bulb
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: obturator, bulb
Clinical Study to Assess the Pharmacokinetics, Safety and Tolerability of Single and Multiple Oral Doses of AFQ056 in Children With Fragile X Syndrome (FXS)
Condition: Fragile X Syndrome
MeSH terms: Fragile X Syndrome; Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of this study is to characterize the pharmacokinetics and safety/tolerability of
      AFQ056 in children with Fragile X Syndrome(FXS)
    


Intervention name(s): AFQ056
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Fragile X Syndrome; pharmacokinetics; safety and tolerability