bioihbjkbjnl/mcl2 huggingface dataset:
Epidemiology of Viral Hepatitis Among Subjects in Precarious
Condition: Social Insecurity
MeSH terms: Hepatitis
Study type: Interventional

Summary: 
      Social insecurity is a significant cost in human terms (health and societal), it defines evil
      and can be identified as difficulties accessing health and especially water.

      We chose to take stock of these populations defined by difficulties accessing water as
      precarious setting. Subjects homeless population fall into this by accident of life, a life
      "homeless" or migrant subjects often illegally having only transitory access (associative or
      charitable structures host) the conditions precarious sanitation including drinking water or
      toilet. Populations of slums in the same conditions or the presence rationed water (one tap
      for 150 people) restricts hygiene.
    

Detailed description: 
      Social insecurity is a significant cost in human terms (health and societal), it defines evil
      and can be identified as difficulties accessing health and especially water.

      We chose to take stock of these populations defined by difficulties accessing water as
      precarious setting. Subjects homeless population fall into this by accident of life, a life
      "homeless" or migrant subjects often illegally having only transitory access (associative or
      charitable structures host) the conditions precarious sanitation including drinking water or
      toilet. Populations of slums in the same conditions or the presence rationed water (one tap
      for 150 people) restricts hygiene.

      The sampling system as part of a consultation in routine care (will be in DBS (blotter) only
      alternative to invasive venous sample and requiring heavier care facility. The capillary
      sampling on filter will also detect a marker of malnutrition .

      Thus in live in large social precariousness adult this study should show which interventions
      in public health and management proposals are most appropriate for this population.
    

Intervention name(s): capillary sampling
Intervention type(s): Biological
Intervention description(s): After elution in buffer (PBS-Tween azide and thiamol) eluate 200 microliter is processed on automated techniques (Siemens Centaur XL and Diasorin) after adjustment of the figures according to ISO 15189 scope B.
The results are qualitatively made and sent to the teams. The return of results, a proposal for appropriate care in the event of contact with virus (anti-HAV HCV HBV) through a rendering consultation results
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Functional Outcome in Two Types of Total Knee Replacement Surgery for People With Osteoarthritis
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional
Phase: Phase 2

Summary: 
      When performing total knee replacement surgery, the surgeon has a choice as to which type of
      surgical technique to use. The standard technique at the Royal Infirmary in Edinburgh is the
      so-called 'medial parapatellar' exposure. And alternative and more recently introduced
      technique is the 'Mid-vastus approach' in which the surgeon will cut through less of the
      muscle at the front of the leg. In this study we compare the two surgical techniques in a
      so-called randomized trial. This means that we put people randomly into two groups, one group
      will receive surgery with the 'Mid-vastus approach' and the other group the surgery with the
      'Medial parapatellar approach'. It is hypothesized that people who receive the Mid-vastus
      approach recover quicker and have a better short-term functional outcome than people who
      receive the 'Medial parapatellar approach'.
    

Detailed description: 
      This study is a prospective randomized controlled double blind trial in which both immediate
      post-operative recovery and functional outcome at 6 weeks, 3 and 6 months after total knee
      replacement surgery will be assessed for two different types of surgical approach; Medial
      Parapatellar and Mid-vastus.

      Functional outcome will be assessed by recording the kinematics of the lower limb joints in
      addition to muscle activity (electromyography) during walking, stair ascending and descending
      and getting up from a chair through computerized 3D motion analysis. Outcome measures will be
      recorded immediate post surgery and at medium follow-up and will cover all areas of the World
      Health Organisation, International Components of Functioning, Disability and Health (ICF)
      components 'Body Structures and Functions/Impairments' ,'Activities and Participation' and
      'Personal factors'. It is hypothesized that by minimizing the damage to the quadriceps,
      patients operated using the Mid-vastus approach will have better muscle function and will
      therefore have more normal knee range of motion, knee joint loading and muscle activity
      patterns compared to those with the Medial Parapatellar approach.
    

Intervention name(s): Mid-vastus approach; medial parapatellar approach
Intervention type(s): Procedure; Procedure
Intervention description(s): Mid-vastus approach to avoid patellar eversion and to minimise the muscle split.; medial parapatellar approach
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Total Knee Arthroplasty; function
N2004-04: Fenretinide LXS in Treating Patients With Recurrent, Refractory, or Persistent Neuroblastoma
Condition: Neuroblastoma
MeSH terms: Neuroblastoma
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Drugs used in chemotherapy, such as fenretinide LXS, work in different ways to
      stop the growth of tumor cells, either by killing the cells or by stopping them from
      dividing.

      PURPOSE: This phase I trial is studying the side effects and best dose of fenretinide LXS in
      treating patients with recurrent, refractory, or persistent neuroblastoma.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the maximum tolerated dose of fenretinide (4-HPR) Lym-X-Sorb™ (LXS) oral
           powder (4-HPR/LXS oral powder) in patients with recurrent, refractory, or persistent
           neuroblastoma.

        -  Define the toxicities of 4-HPR/LXS oral powder in these patients.

        -  Determine the plasma pharmacokinetics of 4-HPR/LXS oral powder and its metabolites in
           these patients.

        -  Determine the tolerability of the combination of ketoconazole and 4-HPR/LXS oral powder
           in these patients.

      Secondary

        -  Determine the response rate in patients treated with 4-HPR/LXS oral powder.

        -  Determine the level of 4-HPR/LXS oral powder in normal peripheral blood mononuclear
           cells (PBMC) as a tumor cell surrogate tissue.

        -  Determine plasma levels of 4-HPR/LXS oral powder when given in combination with
           ketoconazole.

        -  Determine whether ketoconazole increases 4-HPR/LXS oral powder plasma levels.

      OUTLINE: This is a dose-escalation study of fenretinide (4-HPR) Lym-X-Sorb™ (LXS) oral
      powder, followed by an open-label study. Patients are sequentially assigned to 1 of 2
      intervention groups.

        -  Group I: Patients receive 4-HPR/LXS oral powder 3 times daily on days 0-6.

        -  Group II: Patients receive 4-HPR/LXS oral powder as in group I and oral ketoconazole
           once daily on days 0-6.

      In both groups, treatment repeats every 21 days for at least 6 courses in the absence of
      disease progression or unacceptable toxicity. Patients in complete remission at study
      enrollment may receive up to 12 courses (9 months) of therapy.

      Blood samples are collected at baseline and during courses 1, 2, and 6 for pharmacokinetic
      and correlative studies.

      After completion of study treatment, patients are followed periodically.

      PROJECTED ACCRUAL: A total of 32 patients will be accrued for the dose-escalation portion and
      36 will be accrued for the open-label portion of this study.
    

Intervention name(s): fenretinide lipid matrix; ketoconazole; laboratory biomarker analysis; pharmacological study
Intervention type(s): Drug; Drug; Other; Other
Intervention MeSH terms: Ketoconazole; Fenretinide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: recurrent neuroblastoma
The Effect of Hypoglycaemia on Brain Lactate Accumulation and Cerebral Blood Flow
Condition: Type 1 Diabetes Mellitus; Hypoglycemia Unawareness
MeSH terms: Unconsciousness; Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypoglycemia
Study type: Interventional

Summary: 
      Iatrogenic hypoglycemia is the most frequent acute complication of insulin therapy in people
      with type 1 diabetes (T1DM). Recurrent hypoglycemic events initiate a process of habituation,
      characterized by suppression of hypoglycemic symptoms and lead to hypoglycemia unawareness,
      which in itself defines a particularly high risk of severe hypoglycemia. Recent evidence
      suggest a pivotal role for increased brain lactate transport capacity in the pathogenesis of
      hypoglycemia unawareness. However, there is uncertainty about the magnitude of this effect
      and whether such excess brain lactate is oxidizes as a glucose-sparing alternative energy
      source or acts as a metabolic regulator controlling brain glucose metabolism, oxygen
      consumption and cerebral blood flow.

      Objective: The primary objective of this study is to investigate the effect of hypoglycemia
      on brain lactate accumulation and regional cerebral blood perfusion in humans. The secondary
      objective is to assess whether this effect is a related to hypoglycemia unawareness or a
      consequence of T1DM per se.

      Hypothesis: The investigators hypothesize that hypoglycemia stimulates lactate transport over
      the blood-brain barrier leading to cerebral lactate accumulation and that this lactate
      accumulation is a function of prior hypoglycemic exposure frequency contributing to clinical
      hypoglycemia unawareness. Furthermore, the investigators expect that this effect of
      hypoglycemia on brain lactate accumulation is related to changes in cerebral blood flow
      (CBF).
    


Intervention name(s): hypoglycemia; euglycemia
Intervention type(s): Other; Other
Intervention description(s): Blood glucose levels will be kept at ~3.0 mmol/l; Blood glucose levels will be kept at ~5.0 mmol/l
Other intervention name(s): Low blood glucose levels; Normal blood glucose levels
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Type 1 Diabetes Mellitus; Hypoglycemia unawareness; 1H MRS; Lactate
Pilot Study of Startle-response Test to Assess Transcranial Direct Current Stimulation-induced Modulation of Hyperphagia in Prader-Willi Syndrome
Condition: Hyperphagia; Prader-Willi Syndrome
MeSH terms: Prader-Willi Syndrome; Syndrome; Hyperphagia
Study type: Interventional

Summary: 
      The purpose of this study is to determine the effects of transcranial direct current
      stimulation (tDCS) as it modifies hyperphagia in obese subjects, non-obese subjects, and
      subjects with Prader-Willi syndrome (PWS).
    

Detailed description: 
      PWS is characterized by hypotonia, feeding difficulties, developmental delay and failure to
      thrive during infancy, and by an insatiable appetite (hyperphagia), rapid weight gain and
      obesity in early childhood.

      Hyperphagia is one of the most prominent and debilitating features of PWS, and currently no
      pharmaceutical drug has been successful in decreasing appetite in such patients.

      tDCS is a safe, noninvasive method whereby a weak electric current is directly transmitted
      into the brain via external electrodes connected to a 9-volt radio battery. It is based on
      decades-old observations that nerve cell firing can be altered by low amplitude direct
      current (DC). The researchers in this study believe that tDCS may have a positive impact on
      hyperphagia and weight.

      In this study, the investigators intend to assess whether the effects tDCS differ between
      obese subjects, non-obese subjects, and subjects with Prader-Willi syndrome by measuring the
      amplitude and latency of eyeblink startle responses to a set of food- and non-food-related
      visual stimuli in all subjects, various hyperphagia questionnaires, and cognitive and
      behavioral assessments. It is hypothesized that as a group, subjects with Prader-Willi
      syndrome will demonstrate behavioral and psychometric evidence of abnormal food image
      processing, craving and associated behaviors relative to our control groups, and this group
      may receive potentially beneficial effects from tDCS sessions. Obese subjects are also
      predicted to have decreased hyperphagia and food cravings as a result of tDCS.
    

Intervention name(s): tDCS
Intervention type(s): Device
Other intervention name(s): ActivaDoseII
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Obesity; Over weight
Optimising FSH Dosage During in Vitro Fertilization Fertilization (IVF)
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional

Summary: 
      During in vitro fertilisation (IVF) treatment, women receive hormone stimulation with
      gonadotropins to induce growth of several ovarian follicles. Selecting the optimal dosage of
      gonadotropin is important to avoid maturation of too few or too many follicles, which may
      impair the chances of treatment success, lead to treatment cancellation, or serious side
      effects.

      Motivated by the lack of standardised procedures to estimate the optimal dosage of
      gonadotropins, a patient-specific test has been developed to predict the optimal hormone
      dosage. By measuring internalisation of gonadotropin by the patient's monocytes isolated form
      the peripheral blood ex vivo, the Gonadotropin Removal Test determines whether a patient
      needs increased or reduced hormon doses.

      In this clinical study the investigators compare deviation from optimal outcome at oocyte
      pick-up day in two patient groups. Optimal outcome of stimulation is defined as 10 oocytes
      collected in the group of patients matching the inclusion criteria of the study.

      The control group receives starting hormone dosage assigned by the clinician according to
      standard clinical procedures. The intervention group receives starting hormone dosage
      adjusted according to the results of the Gonadotropin Removal Test.
    


Intervention name(s): Gonadotropin removal test; Routine IVF method
Intervention type(s): Other; Other
Intervention description(s): Patient receives hormone dosage adjusted according to the results of the Gonadotropin removal test.; Patient receives hormone dosage according to the standard dosage regimen, without revealing the results of the Gonadotropin removal test to the clinician.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: In vitro fertilization
Comparison of Three Soft Bifocal Contact Lenses
Condition: Presbyopia
MeSH terms: Presbyopia
Study type: Interventional

Summary: 
      The primary purpose of the study is to compare the performance of three soft bifocal contact
      lenses in terms of the vision provided by the lenses.
    


Intervention name(s): balafilcon A; senofilcon A production; senofilcon A test
Intervention type(s): Device; Device; Device
Intervention description(s): multifocal contact lens; multifocal contact lens; multifocal contact lens
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
The Utility of Second Generation Colon Capsule Endoscopy in Ulcerative Colitis
Condition: Colitis, Ulcerative
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the accuracy of second generation colon capsule
      (C2) in evaluating colonic mucosal inflammation of ulcerative colitis patients, using
      conventional endoscopy as the gold standard.
    

Detailed description: 
      Consecutive patients with ulcerative colitis will be recruited. Second generation colon
      capsule endoscopy (C2) and conventional colonoscopy will be performed one after another on
      the same day. Colonic mucosal inflammation will be scaled by physicians who review C2 videos
      and those who perform conventional colonosocpies independently. Physicians who review C2
      videos and colonoscopists will be blinded to the findings of colonoscopies and C2 videos,
      respectively.The accuracy of C2 in evaluating mucosal inflammation will be evaluated, using
      conventional endoscopy as the gold standard.
    

Intervention name(s): C2; colonoscopy
Intervention type(s): Device; Procedure
Intervention description(s): C2 and colonoscopy will be performed one after another on the same day
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: capsule colonoscopy; ulcerative colitis
Self-injection and Self-management
Condition: Food Allergy
MeSH terms: Hypersensitivity; Food Hypersensitivity
Study type: Interventional

Summary: 
      The purpose of the present study is to determine if asking adolescent patients (ages 13-17)
      to self-inject an empty syringe into their thigh during routine clinic visits results in
      increased reported comfort with self-injection, reduced anxiety regarding self-injection and
      food allergy management for both patient and caregiver(s), and in greater perceived
      likelihood of epinephrine self-injection, in the event of an emergency.
    

Detailed description: 
      The purpose of the present study is to determine if asking adolescent patients (ages 13-17)
      to self-inject an empty syringe into their thigh during routine clinic visits results in
      increased reported comfort with self-injection, reduced anxiety regarding self-injection and
      food allergy management for both patient and caregiver(s), and in greater perceived
      likelihood of epinephrine self-injection, in the event of an emergency. Forty participants,
      in total, will be recruited during routine visits to an outpatient allergy clinic. Half of
      all participants will be randomized to the behavioral self-management intervention; whereby
      patients will insert a needle attached to an empty syringe into their thigh (simulating an
      injection of epinephrine); the other half of participants will be randomized to the control
      condition, and will be encouraged to speak to their physician about self-injection, but will
      not undergo the self-injection protocol. Prior to randomization, baseline measures will be
      collected on patient's comfort with epinephrine self-injection. Following the self-injection
      protocol and/or the discussion of self-injection with the physician, all participants will
      complete immediate post-intervention questionnaires at clinic about comfort with
      self-injection, health care management and anxiety. One month following the clinic visit, all
      patients will be sent a follow-up questionnaire that will include items identical to the ones
      completed at immediate post-intervention.
    

Intervention name(s): Simulation of epinephrine self-injection
Intervention type(s): Behavioral
Intervention MeSH terms: Epinephrine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Food allergy; self-management; epinephrine self-injection; ntervention; adolescents
A Study of LY2940680 in Healthy Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single dose study of radiolabelled LY2940680 taken by mouth in healthy participants
      to study how the body absorbs and removes LY2940680 from the blood. This study is for
      research purposes only and is not intended to treat any medical condition.
    


Intervention name(s): [^14C]-LY2940680
Intervention type(s): Drug
Intervention description(s): Administered as solution by mouth
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Saxagliptin as Monotherapy in Pediatric Patients With Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy, safety, tolerability, of Saxagliptin
      in pediatric patients with type 2 diabetes.
    


Intervention name(s): Saxagliptin; Placebo (Saxagliptin); Metformin IR; Placebo (Metformin); Metformin (Active Rescue)
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Tablets, Oral, 2.5 mg or 5.0 mg (according to body weight category), Once Daily, 1-52 weeks; Tablets, Oral, Once daily, 1-16 weeks; Tablets, Oral, 500 mg, Once Daily, 17-52 weeks; Tablets, Oral, Once daily, 1-16 weeks; Tablets, Oral, 500 mg, Titrated as needed, 2-52 weeks
Other intervention name(s): BMS-477118; Onglyza
Intervention MeSH terms: Metformin; Saxagliptin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Role of Glare and Spectral Filtering on Contrast Sensitivity: A Pilot Study
Condition: Visual Acuity
MeSH terms: Hypersensitivity
Study type: Interventional

Summary: 
      This will be a split-plot design, randomized, parallel, double-masked feasibility study to
      evaluate the role of a test lens on contrast sensitivity with and without glare.
    


Intervention name(s): Test Lens; Control Lens
Intervention type(s): Device; Device
Intervention description(s): ACUVUE OASYS MAX 1-Day with TearStable Technology and OptiBlue Light Filter; ACUVUE OASYS 1-Day with HydraLuxe Technology
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment