bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Inguinal Hernia Repair on Isokinetic Muscle Strength
Condition: Inguinal Hernia
MeSH terms: Hernia; Hernia, Inguinal
Study type: Interventional

Summary: 
      The aim of the present prospective controlled study is to compare the trunk muscle strength,
      quality of life and neuropathic pain component after Lichtenstein and Kugel procedures.
    

Detailed description: 
      In this study patients underwent inguinal hernia repair will be evaluated for the effect of
      the surgical procedure on abdominal muscle strength.
    

Intervention name(s): lichtenstein; Kugel
Intervention type(s): Procedure; Procedure
Intervention description(s): tension free mesh hernioplasty (lichtenstein) procedure will be applied for inguinal hernia repair; preperitoneal mesh hernioplasty (Kugel) procedure will be applied for inguinal hernia repair
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Concurrent Assessment of Skeletal Muscle Mass and Synthesis/Breakdown in Old Age
Condition: Sarcopenia; Muscle Atrophy
MeSH terms: Sarcopenia; Muscular Atrophy
Study type: Observational

Summary: 
      This study involves minimally-invasive techniques to measure muscle mass, muscle protein
      breakdown and synthesis simultaneously in older age.
    

Detailed description: 
      Most people will have noticed that with age people become frail. This is principally due to
      wasting of skeletal muscle known as "sarcopenia". Crucially, sarcopenia is more than just a
      symptom of weakness and poor functional capacity; it exposes people to an increased risk of
      falls and fractures, impacting quality of life, independence, health status and ultimately
      lifespan. Muscles represent the largest organ in the body, making up over 50% of total body
      weight. Most people know that skeletal muscles are important for movement and to support the
      skeleton, but not everyone is aware of how important muscles are for whole-body health. For
      example, muscles represent a vast protein store containing amino acids (the building blocks
      of protein) which can be broken down in times of fasting, infection and disease in order to
      provide energy to help other vital organs. Because of the detrimental effects on health, and
      the associated health costs, sarcopenia is of grave concern. Therefore, there is a
      significant clinical need to pre-identify at-risk older individuals who have low muscle mass
      so that they can be offered an intervention (of diet, exercise or drug-based) before they
      suffer any of the potential problems outlined above. Current techniques for measuring
      whole-body muscle mass, including MRI and CT are time-consuming, expensive and in huge demand
      in hospital settings, meaning that muscle wasting conditions such as sarcopenia often go
      undiagnosed. In this project we propose a potential solution to this problem by developing a
      diagnostic of sarcopenia that requires only a single drink and subsequent urine collection.
      In addition, throughout this project we aim to explore the mechanisms underlying muscle
      wasting by assessing the muscle of those with low and 'normal' muscle mass.
    

Intervention name(s): D3-Creatine; Deuterium Oxide; D3-3-methylhistidine
Intervention type(s): Other; Other; Other
Intervention description(s): 30mg D3-Creatine to measure muscle mass; D2O provided to measure muscle protein synthesis; D3-3-methylhistidine is provided to measure muscle protein breakdown
Other intervention name(s): D2O; Heavy water; D3-3MH
Intervention MeSH terms: Deuterium Oxide
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Generally healthy older adults
A Study of Pain Relief in Low Back Pain
Condition: Chronic Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a study of the safety and pain-relieving ability of extended release hydrocodone and
      acetaminophen tablets in patients with moderate to severe low back pain
    


Intervention name(s): Extended release hydrocodone and acetaminophen (Vicodin CR); hydrocodone/acetaminophen extended release (Vicodin CR); placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 2 tablets BID; 1 tablet BID; 2 tablets BID
Other intervention name(s): hydrocodone / acetaminophen extended release; hydrocodone/acetaminophen extended release
Intervention MeSH terms: Acetaminophen; Acetaminophen, hydrocodone drug combination; Hydrocodone; Oxycodone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Immunologic Effects of Echinacea
Condition: Upper Respiratory Tract Infections
MeSH terms: Respiratory Tract Infections
Study type: Interventional

Summary: 
      The goal of this study is to determine if Echinacea purpurea stimulates the immune system.
      For the study, 20 healthy adults will be randomized to receive Echinacea purpurea or placebo
      for 10 days. Blood will be drawn to assess immune markers just before beginning the study
      medication, during the 10 day course of medication and after completing the course of
      medication. It is postulated that adults receiving the Echinacea will have evidence of immune
      stimulation and those receiving placebo will not.
    


Intervention name(s): Echinacea purpurea; placebo
Intervention type(s): Biological; Drug
Intervention description(s): Echinacea purpurea 100 mg/ml, 25 ml daily in 2 divided doses for 10 days; placebo 25 ml daily in 2 divided doses for 10 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Echinacea; prevention; immune modulation
Clinical Evaluation of Fitting Investigational Contact Lenses
Condition: Visual Acuity
MeSH terms: Seizures
Study type: Interventional

Summary: 
      This study is a non-randomized, open label, bilateral, non- dispensing clinical trial with
      only one visit. The Eye Care Providers will be provided with a fitting guide and will
      determine the initial study lens selection. Each subject will wear either the investigational
      contact lenses or marketed contact lenses for approximately 30-90 minutes. This study aims to
      evaluate the ECPs impression of the fitting guide for a novel multifocal lens and also their
      success in fitting the lenses.
    


Intervention name(s): JJVC Fitting Guides
Intervention type(s): Device
Intervention description(s): Subjects who are habitual contact lens wearers with Presbyopic correction or Presbyopic symptoms, at least 40 years of age and no more than 70 years of age, will be fitted, according to the fitting guides, with either the Multifocal Contact Lens or an Toric Multifocal Contact Lens if refractive cylinder power of the eye is between -1.00 to -1.50. The Intervention is approximately 30-90 minutes of wear time during a 1-day visit.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: While this study utilizes two contact lenses, the purpose was to evaluate the JJVC fitting guide. This was a non-randomized study in which eye care practitioners used the JJVC fitting guide to fit subjects with a study contact lens. Subjects may fit either in a bilateral or a contralateral fashion.
Masking: None (Open Label)
Primary purpose: Treatment
Argatroban Combined With Antiplatelet Versus Antiplatelet for Acute Ischemic Stroke
Condition: Stroke, Ischemic
MeSH terms: Stroke; Ischemic Stroke; Ischemia
Study type: Interventional
Phase: Phase 4

Summary: 
      Intravenous thrombolysis is considered as the first choice for ischemic stroke. In the recent
      years, endovascular therapy is demonstrated to be effective to treat ischemic with big vessel
      occlusion. However, only a minority of patients can get intravenous thrombolysis or
      endovascular therapy due to the restricted time window and strict indications. Dual
      antiplatelet has been demonstrated to be effective in the patients with high risk of TIA or
      minor ischemic stroke (NIHSS<4). But there is still stroke progression although dual
      antiplatelet. The ischemic stroke patients with NIHSS > 3 has been recommended to give
      aspirin in most guidelines. Of those patients, mild to moderate stroke patients (3<NIHSS<10)
      will result in the poor outcomes if the progression occurs. In addition, large artery
      atherosclerosis (LAA) stroke is prone to progress. So, we argue that the mild to moderate
      stroke with LAA should be give more intensive antiplatelet. In the present study, argatroban
      combined with antiplatelet therapy (3-5 days) is used to treat the proposed patients to
      investigate the safety and effectiveness.
    


Intervention name(s): Argatroban plus dual antiplatelet
Intervention type(s): Drug
Intervention description(s): A continuous argatroban infusion of 1.0 ug/kg per minute for 2-5 days adjusted to a target activated partial thromboplastin time of 1.75 X baseline (about 10%). For the first day, clopidogrel with loading dose 300mg, and aspirin 100mg were given, and followed by clopidogrel 75 mg and aspirin 100mg each day
Intervention MeSH terms: Argatroban
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pancreatic Duodenal Homeobox Factor-1 (PDX-1) and Neurogenin-3 (NGN-3) in Gestational Diabetes
Condition: Gestational Diabetes
MeSH terms: Diabetes, Gestational; Diabetes Mellitus
Study type: Observational [Patient Registry]

Summary: 
      Introduction: Depletion of the ability of the cells ß to secrete the amount of insulin
      required by pregnancy, increasing the risk of develop Gestational Diabetes Mellitus (GDM).
      The aim was to contrast the messenger RNA (mRNA) expression of the pancreatic duodenal
      homeobox factor-1 (PDX-1) and Neurogenin-3 (Ngn-3) in peripheral blood of pregnant women with
      GDM versus women with normal pregnancies.

      Material and methods: This was a prospective, clinical and cross-sectional study, conforming
      two groups of pregnant women: a) patients with a healthy gestation and b) patients with GDM.
      Besides anthropometry and routine laboratorial test, real-time polymerase chain reaction
      (Real-Time PCR), was used to quantify the expression of PDX-1 and NGN-3.
    

Detailed description: 
      Pregnant women attended in the Maternal-Fetal Medicine Service of the "Mónica Pretelini
      Sáenz" Maternal-Perinatal Hospital, were invited to participate. Those with autoimmune
      diseases, heart disease, nephropathy, liver disease or any other chronic condition were
      excluded and those with incomplete clinical files were discarded from the final analysis. Two
      groups were integrated: a) patients with a healthy gestation and b) patients with GDM.

      From all patients the next information was captured in an excell sheet: weight, height, Body
      Mass Index, blood pressure, albumin, creatinine, electrolytes, glucose, total cholesterol,
      triglycerides, transaminases and relative expression of PDX-1 and NGN-3.
    

Observational model: Case-Crossover
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Pregnant women attended in the Maternal-Fetal Medicine Service of the HMPMP.
      
Keywords: PDX-1; NGN-3; Glucose
Use of SMSs to Improve Attendance to Cervical Cancer Follow-up Screening
Condition: Cervical Cancer
MeSH terms: Uterine Cervical Neoplasms
Study type: Interventional

Summary: 
      This study evaluates the effect of the SMS intervention 'Connected2Care' on the attendance
      rate to cervical cancer screening follow-up appointments.
    

Detailed description: 
      Connected2Care is a non-blinded, multicentre, parallel-group, randomised controlled trial.
      Tanzanian Women testing positive to HR HPV at inclusion are randomly assigned in an
      allocation ratio of 1:1 to the SMS intervention or the control group (standard care). In a
      period of 10 months, the intervention group will receive 15 one-directional health educative
      text messages and SMS-reminders for their appointment. The total sample size will be 700 with
      350 women in each study arm. Primary outcome is attendance rate for follow-up. Secondary
      objectives are cost-effectiveness measured through incremental ratios and knowledge of
      cervical cancer by a 16-item true/false scale questionnaire at baseline and follow-up.
    

Intervention name(s): Connected to Care
Intervention type(s): Behavioral
Intervention description(s): 10 health educative SMSs' sent once a month 5 SMS-reminders for follow-up appointment sent on days -14, -7, -1 pre- follow-up appointment, and +1, +7 post follow-up appointment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Screening
Keywords: Mobile health; Screening; Early detection of cancer; HPV; SMS intervention; RCT; Tanzania
Real-time Continuous Glucose Monitoring in Very Low Birth Weight Neonates
Condition: Hypoglycemia
MeSH terms: Hypoglycemia; Birth Weight
Study type: Interventional

Summary: 
      Hypoglycemia is frequent in very low birth weight (VLBW) neonates and compromises their
      neurological outcome. The aim of this study was to compare real-time continuous glucose
      monitoring system (RT-CGMS) to standard method by intermittent capillary blood glucose
      testing in detecting and managing hypoglycemia. The investigators calculated a number of 48
      neonates to be randomized between 2 ways of glucose level monitoring for their 3 first days
      of life : either by RT-CGMS (CGM-group), or by intermittent capillary glucose testing
      (IGM-group) associated with a blind-CGMS to detect retrospectively missed hypoglycemia. The
      investigators' hypothesis is that in the CGM group number and duration of hypoglycemia will
      be lower.
    


Intervention name(s): real time continuous glucose monitoring
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Diagnostic
Keywords: hypoglycemia; very low birth weight neonate; continuous glucose monitoring
The Effect of ESPB on Intraoperative Hemodynamics in VATS
Condition: Video-Assisted Thoracoscopic Surgery; Erector Spinae Plane Block; Mean Arterial Pressure; Heart Rate
Study type: Interventional

Summary: 
      Video-assisted thoracic surgery (VATS) is frequently applied in thoracic surgery operations.
      VATS has become the standard procedure in minor and major lung surgeries. In recent years,
      regional anesthesia techniques have also been frequently applied to patients for pain relief.
      Thoracic paravertebral block (TPVB), erector spinae plane block (ESPB), and serratus anterior
      plane block (SAPB) are also among the regional anesthesia techniques frequently used in
      thoracic surgery.

      General anesthesia (GA) is the main method of anesthesia for thoracic surgery. However, GA
      can only inhibit the projection system of the cortical limbic system or hypothalamic cortex.
      GA cannot completely block the transmission of peripheral noxious stimulus to the central
      nervous system and cannot effectively inhibit the intraoperative stress response. With the
      addition of peripheral blocks such as TPVB, ESPB, and SAPB, more stable hemodynamics is
      expected by providing preemptive analgesia in patients. As a result of all these; In this
      study, we aimed to compare the intraoperative hemodynamic changes of patients who underwent
      preoperative ESPB in patients who will undergo VATS resection under GA with those who
      underwent postoperative ESPB.
    


Intervention name(s): Preoperative Erector spinae plane block; Postperative Erector spinae plane block
Intervention type(s): Procedure; Procedure
Intervention description(s): Erector spinae plane block will be performed unilaterally, under US guidance, before the surgical operation, after the induction of anesthesia, and when the patient is placed in the lateral decubitus position.; Erector spinae plane block will be performed unilaterally, under US guidance, after the surgical operation, under general anesthesia, and when the patient is placed in the lateral decubitus position.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Resin Infiltration to Arrest Early Tooth Decay
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether lesion infiltration is an effective
      management strategy to arrest early tooth decay.
    

Detailed description: 
      A 3-year prospective, randomized control clinical trial (RCT) is designed incorporating a
      split mouth intra-oral design. Young volunteers (18-24 years old) with at least two early
      lesions in posterior teeth will be enrolled into this clinical trial to evaluate the clinical
      effectiveness of arresting lesion progression by resin infiltration therapy as adjunct to
      standard-of-care preventative measures. Lesion status (non-cavitated) is clinically confirmed
      prior to implementing the assigned therapy.
    

Intervention name(s): Resin infiltration; Sham treatment
Intervention type(s): Device; Device
Intervention description(s): Baseline treatment of one caries lesion with resin infiltration therapy, in addition to preventative measures and behavioral modification.
ICON product: FDA-510(k): K100062; Baseline treatment of one caries lesion with sham treatment, in addition to preventative measures and behavioral modification.
Other intervention name(s): ICON Infiltration kit (DMG, Germany) (ICON=product name)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Dental caries; Proximal surfaces; Posterior teeth; Carious lesions; Tooth diseases; Preventive therapy
Optimal Doses for Drug Provocation Tests to Beta-lactams
Condition: Drug Hypersensitivity
MeSH terms: Hypersensitivity; Drug Hypersensitivity
Study type: Interventional

Summary: 
      Drug provocation tests (DPT) are widely in case of suspicion of drug hypersensitivity (and in
      the absence of contraindications), but there are no standardized protocols and most groups
      use hypothesis (clinically-driven) protocols.

      investigators used 20 year experience in drug hypersensitivity to analyse retrospectively 171
      patients (accounting for 182 positive DPT to beta-lactams). Using survival analysis, they
      identified optimal doses to include in a data-driven protocol. This data-driven protocol will
      be applied to new prospective patients, to test its safety and benefits (gain in time,
      hospital and patient benefits).
    


Intervention name(s): simplified drug provocation test
Intervention type(s): Procedure
Intervention description(s): Assessment of the Hypersensitivity to betalactams by simplified drug provocation test
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Betalactams; Drug hypersensitivity; Drug provocation test; Reactive dose
Prospective Clinical Evaluation of the New Aegis Plate for Anterior Interbody Fusions
Condition: Degeneration; Spondylosis; Spondylolithesis; Stenosis
MeSH terms: Spondylosis
Study type: Observational

Summary: 
      Introduction: Degenerative changes of the discs and facet joints in the lumbar spine can
      result in pain and disability from spondylosis, spondylolisthesis and stenosis. Patients who
      are suffering with back and/or leg pain are potential candidates for an ALIF procedure.

      Purpose: To assess and compare clinical outcomes and fusion rates in patients undergoing an
      instrumented ALIF procedure. Comparisons in all variables will be made across diagnostic
      categories. Comparisons between type of interbody spacer, graft type, and type of
      instrumentation will also be made
    

Detailed description: 
      To assess and compare clinical outcomes and fusion rates in patients undergoing an
      instrumented ALIF procedure. Comparisons in all variables will be made across diagnostic
      categories. Comparisons between type of interbody spacer, graft type, and type of
      instrumentation will also be made.

      This study is part of a larger Continuous Quality Improvement initiative at the Columbia
      Orthopaedic Group. The purpose of this effort is to improve surgical and non-surgical
      outcomes by using rigorous statistical analysis of our outcomes to guide our treatment
      decisions. Through an iterative feedback process we hope to optimize patient outcomes.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Any person who comes into the clinic and gives consent to participate in this prospective
        study.
      
Keywords: Degeneration; Spondylosis; Spondylolisthesis; Stenosis
A Phase 1, Open-Label, 10 Day Safety Study
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1 open-label study in healthy volunteers who will receive oral 200 mg TR 701
      FA once daily for 10 days and will include ophthalmologic and neurologic assessments.
    

Detailed description: 
      This is a Phase 1 open-label study in healthy volunteers who will receive oral 200 mg TR 701
      FA once daily for 10 days (Days 1 through 10) and undergo safety evaluations including
      ophthalmologic and neurologic assessments before (Screening or Day -1), 1 day after final
      study drug administration (Day 11 or earlier if a subject discontinues treatment), and 2 to 4
      weeks after the last study drug administration (Late Follow-up Visit).
    

Intervention name(s): TR-701 FA
Intervention type(s): Drug
Intervention description(s): TR-701 FA 200 mg once daily
Other intervention name(s): Tedizolid Phosphate
Intervention MeSH terms: Tedizolid phosphate; Tedizolid
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other