bioihbjkbjnl/mcl2 huggingface dataset:
A Prospective Trial Comparing Metal to Plastic Speculums for Patient Comfort
Condition: Patient Comfort
Study type: Observational

Summary: 
      The purpose of this study is to evaluate the comfort of two type of speculums used during
      routine gynecologic exam. Your treatment and medical care will not change because you are
      participating in this study. Your doctor will continue to make all decisions regarding your
      proper treatment and care.
    

Detailed description: 
      Speculum examination is a common procedure in the gynecology clinic used for evaluation of
      numerous conditions such as vaginitis, and during cervical cytology screening (PAP smears).
      The speculum is inserted into the woman's vagina and used to keep the vaginal walls apart
      during exam and procedures. Each step of the examination with a speculum including insertion,
      manipulation during examination, and removal can cause discomfort for the patient. Fear of
      examination pain is considered one barrier to examination compliance. Any method to decrease
      discomfort during the exam would be considered beneficial to patient screening.

      Typically two types of speculums are used in clinical practice, metal and plastic. There are
      advantages to both, and usage is usually predicated by physician preference. Previous studies
      have demonstrated a clear difference in patient comfort between metal speculums and newer
      dilating speculums such as the Vera scope (1). Clinical trials have also shown the benefit of
      using lubrication on metal speculums during routine exams (2). To date there are no clinical
      trails to examine the difference in patient comfort between metal and plastic bi-valve
      speculums.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women greater than 18 years of age presenting for routine speculum exam
      
Keywords: Speculum; Metal; Plastic; Visual Analoge Scale; Discomfort
Effect of L-PRF and A-PRF in Ridge Preservation
Condition: Atrophic Maxilla; Ridge Preservation
MeSH terms: Atrophy
Study type: Interventional

Summary: 
      A split-mouth design study will be performed regarding the use of platelet concentrates on
      ridge preservation: L-PRF vs A-PRF vs control. Patient needing multiple teeth extractions in
      the upper jaw (single-rooted teeth) will be recruited. The use of each platelet concentrate
      or control will be randomized by means of a computer program. The results will be analysed
      clinical and radiographically (CBCT). When the subject will choose for implant
      rehabilitation, a biopsy will be taken in the site of the preserved sockets. The region will
      be localized with a customized stent, fabricated with the position of the extracted teeth.
      VAS scales will be provided to evaluate the post-operative discomfort.
    


Intervention name(s): L-PRF; A-PRF
Intervention type(s): Other; Other
Intervention description(s): Platelet concentrates are produced from a small peripheral blood sample, which is immediately centrifuged without any anticoagulant. Coagulation starts during the centrifugation, and three layers are obtained: red blood corpuscles (RBCs) at the bottom of the tube, platelet-poor plasma (PPP) on the top and an intermediate layer called "buffy coat" where most platelets and leucocytes are concentrated. L-PRF has potential advantages, namely: it creates a bioactive construct that stimulates the local environment for differentiation and proliferation of stem and progenitor cells and it acts as an immune regulation node with inflammation control abilities, such as slow continuous release of growth factors over a period of 7-14 days.; Platelet concentrates are produced from a small peripheral blood sample, which is immediately centrifuged without any anticoagulant. Coagulation starts during the centrifugation, and three layers are obtained: red blood corpuscles (RBCs) at the bottom of the tube, platelet-poor plasma (PPP) on the top and an intermediate layer called "buffy coat" where most platelets and leucocytes are concentrated. L-PRF has potential advantages, namely: it creates a bioactive construct that stimulates the local environment for differentiation and proliferation of stem and progenitor cells and it acts as an immune regulation node with inflammation control abilities, such as slow continuous release of growth factors over a period of 7-14 days.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: leucocyte- and platelet rich fibrin; ridge preservation; growth factors; platelet concentrates
Identification of High Risk People for Colorectal Cancer and Evaluation of a Specific Surveillance System
Condition: Cancer Colorectal
MeSH terms: Colorectal Neoplasms
Study type: Interventional

Summary: 
      Colorectal cancer is one the most frequent cancer in developed countries. In France, it rank
      third with 43000 new cases in 2015. French Health Authority recommended colonoscopy screening
      for people with a high risk for colorectal cancer. But this compliance with colonoscopy is
      low (20-40%), it is therefore necessary to develop new strategies to improve compliance.

      The purpose of this project is to to offer and evaluate the feasibility and the effectiveness
      of a specific surveillance system for high risk people for colorectal cancer

      The project will be divided into 2 phases:

      Objectives of the first phase:

        -  Identify high risk people for colorectal cancer in the department of Indre-et-Loire,

        -  Fill in as completely as possible their colonoscopic history in the past 5 years,

        -  Estimate the proportion of high risk people for colorectal cancer in the target
           population for colorectal cancer screening in Indre-et-Loire (Men and women aged from 50
           to 74 years).

      Objective of the second phase:

      Compare the performed colonoscopy rate of high risk people for colorectal cancer without
      notion of colonoscopy in the past 58 months following or not (control group) the sending of a
      letter reminding the importance of compliance with colonoscopy.
    


Intervention name(s): Reminder letter
Intervention type(s): Behavioral
Intervention description(s): The letter will consist in several parts:
Reminder of : -the need of individual follow-up for high risk people for colorectal cancer AND - the general recommendations (one colonoscopy every 5 years)
Recommendation to consult their general practitioner or gastroenterologist if they haven't done their follow up
Request information if they've done their follow-up or if we have incorrect information
Indication that the letter is sent as part of a surveillance program specific for high risk people for colorectal Cancer
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: high risk; surveillance; screening; colonoscopy
Effect of Diet Versus Sleeve Gastrectomy and Gastric Bypass on Appetite
Condition: Obesity
Study type: Interventional

Summary: 
      The biggest challenge in obesity management is maintaining weight loss in the long-term.
      Currently, bariatric surgery is the most effective treatment, leading to sustained weight
      loss that is not yet achievable with lifestyle intervention (e.g. diet). The reasons behind
      its success is still not clearly understood, but beneficial changes in the homeostatic and
      hedonic appetite systems (the two major physiological regulators of appetite), along with the
      microbiome (known to have a mediatory effect on appetite) have been shown to occur after
      bariatric surgery. These alterations are in opposition to what is seen after diet-induced
      weight loss. Today, the component of appetite regulation that drives bariatric surgeys'
      long-term success is still unknown. By comparing a lifestyle and surgical intervention in
      parallel, the investigators can observe the impact of a similar magnitude of weight loss on
      these three domains of appetite regulation simultaneously, thereby illuminating the
      mechanisms behind bariatric surgerys' success.
    


Intervention name(s): VLED group; Sleeve Gastrectomy group; Gastric Bypass group
Intervention type(s): Dietary Supplement; Procedure; Procedure
Intervention description(s): 10-week weight loss period with total meal replacement, consisting of 750 kcal/day. Measurements will be taken at baseline (before diet start), 10 weeks after intervention start (Wk11), and at 1 year.; Standard clinical practice with 2-week diet consisting of 750 kcal/day prior to surgery. The pre- and post-surgical diet of this group will be matched with the VLED group in macro- and micronutrient composition. Measurements will be taken at baseline (before diet start), 10 weeks after intervention start (Wk11), and 1 year after surgery (sleeve gastrectomy); Standard clinical practice with 2-week diet consisting of 750 kcal/day prior to surgery. The pre- and post-surgical diet of this group will be matched with the VLED group in macro- and micronutrient composition. Measurements will be taken at baseline (before diet start), 10 weeks after intervention start (Wk11), and 1 year after surgery (gastric bypass)
Other intervention name(s): very-low-energy-diet
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: diet; bariatric surgery; appetite
Prevalence of Acute Critical Neurological Disease in Children: a Global Epidemiological Assessment
Condition: Cardiac Arrest; Stroke; Traumatic Brain Injury; Brain Mass; Status Epilepticus; Spinal Cord Disease; Hydrocephalus
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Hydrocephalus; Status Epilepticus; Nervous System Diseases; Spinal Cord Diseases
Study type: Observational

Summary: 
      PANGEA is an international prospective point prevalence study to describe the epidemiology,
      interventions, and outcomes in children with acute critical brain disease.
    


Intervention name(s): No intervention
Intervention type(s): Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Critically-ill children with acute neurologic injury
Evaluation of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Effects of PER977 Following Heparin
Condition: Healthy
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Normal subjects will receive unfractionated heparin followed by a single dose of PER977 with
      dose escalation by cohort. Ten subjects enrolled in Cohort 4 will receive a single dose of
      PER977 followed by a one-week washout and then will receive unfractionated heparin followed
      by a single dose of PER977. The study will provide some insight into the doses that may be
      required to reverse anticoagulation induced by heparin.
    


Intervention name(s): PER977; Placebo; Heparin Sodium
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Reversal of heparin-induced anticoagulation; Reversal of heparin-induced anticoagulation
Intervention MeSH terms: Heparin; Calcium heparin
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: PER977; heparin; anticoagulation reversal; whole blood clotting time
Shigella WRSS1 Vaccine Trial in Bangladesh
Condition: Diarrhea
MeSH terms: Diarrhea
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a research study of an experimental (investigational) live attenuated Shigella sonnei
      vaccine (WRSS1) to find a dose of the vaccine that is safe, tolerable, and develops an immune
      response. Shigella causes bloody and watery diarrhea, and infants and children living in
      developing countries experience the greatest consequences of this disease.
    

Detailed description: 
      The WRSS1 vaccine in will be given to healthy toddlers (12-24 months old). The first
      vaccination was given to toddlers in the inpatient unit and the second and third doses will
      be administered on an outpatient basis. A safety evaluation was performed after the first
      dose before enrolling subjects in subsequent cohorts to receive a higher vaccine dose.

      After the study was initiated, its funder, the Bill and Melinda Gates Foundation (BMGF) made
      significant changes to the PATH Enteric Vaccine Initiative (EVI) portfolio and decided not to
      support the three higher-dose cohorts (Cohort 1, 2, and 3) planned as part of this study.
    

Intervention name(s): Shigella sonnei Strain WRSS1 Vaccine; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Live attenuated, oral Shigella WRSS1 vaccine; Sterile saline solution
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: shigellosis; Enterobacteriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases
Effects of tDCS on Maximal Isometric Strength and Endurance Test of Trunk Extensors.
Condition: Healthy
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Improving trunk muscle strength and endurance is one of the many goals to be achieved in
      rehabilitation protocols for a variety of health conditions. Cerebral electrical stimulations
      techniques, such as transcranial direct current stimulation (tDCS) can modulate motor brain
      areas involved in motor functions. However, their effects on trunk function are lacking.

      This study aims to investigate the effects of transcranial direct current stimulation (tDCS)
      on trunk muscle strength and endurance in healthy subjects.
    


Intervention name(s): Transcranial direct current stimulation (tDCS)
Intervention type(s): Device
Intervention description(s): The noninvasive and nonpharmacological weak electrical current applied to the scalp to modulate cortical excitability.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
A Study To Investigate The Metabolism Of GW876008 In Smokers Compared To Non-Smokers.
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will investigate the effect of smoking on the metabolism of a single oral dose of
      GW876008.
    


Intervention name(s): GW876008
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Pharmacokinetics,; tolerability,; healthy,; subjects,; smokers,; non-smokers
Influence of Mango Intake of Skin Health in Postmenopausal Women
Condition: Wrinkle; Skin Red
MeSH terms: Erythema
Study type: Interventional

Summary: 
      This study aims to investigate the effects on 16 weeks of mango intake on skin health in
      postmenopausal women. Half of the participants will receive 85g portions of mangoes while the
      other half receive 250g portions of mangos. Participants will be instructed to consume the
      specific portion 4 times a week, for a total duration of 16 weeks.
    

Detailed description: 
      Mangoes are rich in carotenoids, flavonoids, vitamins and other active phytochemicals such as
      resistant starches. Although a role of mangoes in skin health has long been advocated in
      traditional medicine, little scientific research has been conducted.

      We hypothesize that 85g (0.5 cups) of mango intake for 16 weeks will have minimal impact on
      skin health, while 250g (1.5 cups) of mango intake will produce significant benefits.
    

Intervention name(s): 16 weeks mango intake
Intervention type(s): Other
Intervention description(s): Participants will be provided fresh frozen Ataulfo mangoes.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Skin Health; Skin Wrinkle; Skin Redness; Carotenoid; Mango
DD Obesity MRI Study
Condition: Diverticular Disease
MeSH terms: Diverticular Diseases; Diverticulum
Study type: Observational

Summary: 
      In this study, our novel MRI techniques for studying the small bowel will be applied to
      patients with diverticular disease. The ratio of visceral to subcutaneous fat will also be
      determined using MRI measurements. These data will be correlated with measurements of
      adipokines to determine if visceral fat has a specific influence on the severity of
      diverticular disease.
    

Detailed description: 
      Colonic diverticulosis is the most common structural abnormality of the colon and studies
      suggest that its incidence and/or complications are increasing. Increasing evidence suggests
      a link between obesity and complications of diverticular disease. With the prevalence of
      obesity increasing in westernised populations, the risk of complications from diverticular
      disease is likely to also increase. At present however, there is little understanding of how
      diverticular complications are increased by obesity. A high BMI might be a surrogate marker
      for other lifestyle factors which predispose to diverticular complications. Visceral fat may
      also have an influence on related complications, due to the compounds secreted by adipocytes.

      Altered bowel habit is a common complaint of diverticular patients. The cause is not well
      understood, is probably multi-factorial, and may include changes in the small bowel. Until
      recently, studies of the large and small bowel required intestinal intubation and perfusion
      and could not be performed on the undisturbed colon. New MRI techniques have now been
      developed, which allow these areas to be studied non-invasively. Abdominal fat can also be
      measured using MRI, and the distribution of subcutaneous and visceral fat will be compared
      for symptomatic and asymptomatic diverticular patients.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participants will include:

          1. Participants with symptomatic DD stratified by patient heath questionnaire 12 somatic
             symptom scale

          2. Participants with asymptomatic DD
      
Biospecimen description: 
      Serum and stool
    
Keywords: diverticular disease; MRI; visceral and subcutaneous fat; adipokines
Comparison of Dehydrated Human Amnion-Chorion and Type 1 Bovine Collagen Membranes for Guided Bone Regeneration
Condition: Ridge Deficiency
MeSH terms: Dehydration
Study type: Interventional

Summary: 
      The objective of this randomized clinical study was to evaluate the use of dehydrated human
      amnion-chorion membrane as an exposed barrier for guided bone regeneration (GBR) after tooth
      extraction and to determine whether intentional exposure of this membrane to the oral
      environment compromises ridge dimensions and bone vitality for implant placement.
    

Detailed description: 
      Forty-three patients requiring extraction of at least one tooth and delayed implant placement
      were randomly assigned to either an experimental or a control group. For both groups,
      demineralized freeze-dried bone allograft was used to graft the socket. For the control
      group, Type I bovine collagen was used as a membrane; for the experimental group, human
      amnion-chorion membrane was used. For both groups, the barrier membranes were left exposed,
      and no primary closure was achieved. Patients returned for implant placement after a mean
      healing period of 19.5 weeks, at which time a core bone biopsy specimen 2 mm in diameter was
      obtained for histomorphometric analyses. Clinical ridge dimensions were measured at the times
      of extraction and implant placement.
    

Intervention name(s): Guided Bone Regeneration (GBR)
Intervention type(s): Procedure
Intervention description(s): Teeth Extraction With Bone Grafting and Membrane
Other intervention name(s): Ridge Preservation
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Guided Bone Regeneration; Dehydrated Human Amnion Chorion Membrane; Type I Bovine Collagen Membrane; Ridge Preservation; Ridge Healing; Teeth Extraction
Milk Patch for Eosinophilic Esophagitis
Condition: Eosinophilic Esophagitis; Milk Allergy
MeSH terms: Esophagitis; Eosinophilic Esophagitis; Milk Hypersensitivity
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a single-site, double-blind, placebo-controlled, randomized trial to study efficacy
      and safety of the Viaskin® Milk Patch for children with milk induced Eosinophilic Esophagitis
      (EoE). 20 subjects will be randomized 3:1 to Viaskin® Milk or placebo patch.
    

Detailed description: 
      This is a double-blind, placebo-controlled, randomized trial to study the efficacy and safety
      of Viaskin® Milk, an allergen extract of milk administered epicutaneously using the Viaskin®
      epicutaneous delivery system (EPIT) in subjects from 4 to 17 years old with a milk induced
      Eosinophilic Esophagitis. Subjects will be randomized in a 3:1 ratio into two different
      treatment groups, to receive EPIT with Viaskin® Milk (500 µg of milk proteins) or placebo.

      Subjects who complete the double-blind treatment period (approximately 11 months), will
      automatically rollover into an open label treatment period (additional 11 months). All
      subjects will receive the 500 µg (micrograms) Viaskin Milk patch.
    

Intervention name(s): Viaskin Milk 500 mcg; Viaskin Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Biological: Viaskin Milk 500 mcg Subjects epicutaneously administered daily (up to 24 hours application per day) with a patch containing 500 mcg cow's milk proteins.; Biological: Viaskin Placebo Subjects epicutaneously administered daily (up to 24 hours application per day) with a patch containing a matching placebo formulation.
Other intervention name(s): Milk Patch; Viaskin Epicutaneous ImmunoTherapy (EPIT); Placebo Patch; Placebo Epicutaneous ImmunoTherapy (EPIT)
Intervention MeSH terms: Immunomodulating Agents; Immunologic Factors
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Milk Allergy; Viaskin Milk; Epicutaneous ImmunoTherapy (EPIT); Eosinophilic Esophagitis; Milk-Induced Eosinophilic Esophagitis