bioihbjkbjnl/mcl2 huggingface dataset:
Delayed Mycophenolate Mofetil in Single-Donor Islet Allotransplantation in Type 1 Diabetes
Condition: Type 1 Diabetes; Hypoglycemia
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypoglycemia
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The objective of this study is to assess the safety and efficacy of islet allotransplantation
      for the reestablishment of stable glycemic control in patients with type 1 diabetes, using
      anti-thymocyte globulin induction immunosuppression with sirolimus, mycophenolate mofetil and
      low dose tacrolimus maintenance immunosuppression.
    

Detailed description: 
      To assess the safety and efficacy of a new single-donor islet allotransplant protocol
      focusing on minimization of ischemic damage by the two-layer pancreas preservation technique,
      attenuation of posttransplant nonspecific inflammatory responses by etanercept and
      anti-thymocyte globulin, deletion/inactivation of autoreactive T cells by anti-thymocyte
      globulin and daclizumab induction immunotherapy, and potent yet non-diabetogenic maintenance
      immunosuppression with sirolimus and delayed mycophenolate mofetil instead of tacrolimus for
      the reestablishment of stable glycemic control in recipients with type 1 diabetes.
    

Intervention name(s): Allogeneic islets of Langerhans transplant
Intervention type(s): Biological
Intervention description(s): Allogeneic islets of Langerhans transplant
Other intervention name(s): Islet transplant
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Ketamine+Propofol vs Remifentanyl+Propofol on Laryngeal Mask Insertion Conditions
Condition: Surgery
Study type: Observational [Patient Registry]

Summary: 
      Laryngeal mask airway is a common tool for airway management during anesthesia in many
      surgeries. Insertion of laryngeal mask needs deep anesthesia, suppression of airway, stabile
      hemodynamic response. Many drug regimens has been used for this purpose. This study aimed to
      compare the insertion conditions of laryngeal mask by using ketamine+propofol versus
      remifentanil + propofol.
    


Intervention name(s): Ketamine; remifentanyl; propofol; laryngeal mask
Intervention type(s): Drug; Drug; Drug; Device
Intervention description(s): To compare ketamine+propofol versus remifentanyl+propofol to maintain good laryngeal mask insertion conditions
Other intervention name(s): Remifentanyl
Intervention MeSH terms: Ketamine; Remifentanil; Propofol
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Surgery performed with laryngeal mask as airway tool in gynecologic clinic
      
Keywords: Laryngeal mask; Ketamine; Remifentanyl
Brivaracetam as add-on Treatment in Adolescents and Adults Suffering From Epilepsy
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will compare the safety and efficacy of Brivaracetam at flexible dose with Placebo
      in subjects suffering from Epilepsy.
    


Intervention name(s): Placebo; Brivaracetam
Intervention type(s): Drug; Drug
Intervention description(s): Daily oral dose of two equal intakes, morning and evening, of Placebo in a double-blinded way for the 16-week Treatment Period; Daily oral dose of two equal intakes, morning and evening, Brivaracetam 20 mg/day or Brivaracetam 50 mg/day or Brivaracetam 100 mg/day or Brivaracetam 150 mg/day, in a double-blinded way for the 16-week Treatment Period
Intervention MeSH terms: Brivaracetam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Epilepsy; Brivaracetam; Partial Onset Seizures
Eplerenone, Aflibercept and Topical Nepafenac Serous Foveal Deta Chment in Central Serous Chorioretinopathy
Condition: Central Serous Chorioretinopathy
MeSH terms: Central Serous Chorioretinopathy
Study type: Observational

Summary: 
      describing the influence of; combined Eplerenone, intravitreal Aflibercept, and topical
      Nepafenac; on serous foveal detachment in eyes with CSCR
    

Detailed description: 
      Retrospective Review of records of eyes with Central serous chorioretinopathy (CSCR) that
      have been treated in the period between 2015 and 2021

      After checking inclusion and exclusion criteria; we will enroll all cases that have been
      treated by the combination of eplerenone, intravitreal aflibercept and topical nepafenac.

      Investigators collected and recorded the following data:

        -  Age

        -  Gender

        -  Systemic hypertension (present or not)

        -  Smoking (Yes / No)

        -  Best corrected visual acuity (BCVA) (baseline, final)

        -  Central macular thickness (CMT) (baseline, final)

        -  Serous detachment Height (SDH) (baseline, final)

        -  Duration of Follow-up ( in months)
    

Intervention name(s): Eplerenone , Intravitreal Aflibercept and Topical nepafenac therapy
Intervention type(s): Other
Intervention description(s): Eplerenone , Intravitreal Aflibercept and Topical nepafenac therapy
Intervention MeSH terms: Nepafenac; Aflibercept; Eplerenone
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Eyes with Central serous chorioretinopathy (CSCR) that have been treated in the period
        between 2015 and 2021
Non-comparative Evaluation of Facial Expressions Following Lower Face Correction Using Emervel Classic and Emervel Deep
Condition: Nasolabial Folds; Wrinkles
Study type: Interventional
Phase: Phase 4

Summary: 
      Study is designed to characterize subject and treating investigator reported outcomes in the
      early post-treatment period, following bilateral correction of nasolabial folds using Emervel
      Classic and Emervel Deep.

        1. to evaluate subject-reported return to social engagement, after the initial treatment
           (Baseline/Day 1 visit).

        2. to evaluate change in Global Aesthetic Improvement Scale (GAIS) at day 30-
           subject/investigator reported

        3. to evaluate subject satisfaction with treatment outcome at baseline, day 14 and day 30.

        4. to evaluate change in Wrinkle Severity Rating Scale (WSRS) from baseline to
           post-treatment follow-up time points at day 14 and Day 30 - investigator reported

        5. to evaluate all adverse events during the course of the study
    


Intervention name(s): Emervel Classic; Emervel Deep
Intervention type(s): Device; Device
Intervention description(s): Subjects requiring bilateral correction of NLFs and meeting eligibility criteria will be enrolled and treated with Emervel Classic (moderate NLFs; WSRS = 3/3); Subjects requiring bilateral correction of NLFs and meeting eligibility criteria will be enrolled and treated with Emervel Deep (severe NLFs; WSRS = 4/4).
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study to Assess the ART Impact on the Brain Outcomes. The ARBRE Study
Condition: HIV-1 Infection; Cognitive Impairment
MeSH terms: Infections; Cognitive Dysfunction
Study type: Observational

Summary: 
      The ARBRE Study is an observational prospective trial aimed at investigating the impact of
      the therapy initiation with INTIs on brain outcomes according to the time of therapy
      initiation. Three study arms are considered: 1) Early treated HIV-1 infected patients (<3
      months since estimated date of infection), 2) Regularly treated HIV-1 infected patients (>6
      months since estimated date of infection), 3) Matched seronegative control group. Study
      assessments will be performed at baseline, 1 month and 12 months. Study assessments will
      comprise comprehensive evaluation of brain outcomes. They will include cognitive functioning,
      neuroimaging parameters, and functional outcomes.
    

Detailed description: 
      Randomized patients will receive LA CAB+RPV administration in the hospital (standard of care)
      or out-of- hospital administration every 2 months (M2, M4, M6, M8,M10, M12). Medical visits,
      rutinary blood tests and pharmacy visits at the hospital of reference will take place every 6
      months- at baseline, M1 (if patient has not previously receiving LA CAB+RPV), M6 and M12.
    

Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        HIV patients early treated HIV chronically patients non HIV participants
      
Keywords: Brain; HIV-1 Infection
Computer Assisted Quality-monitoring for Magnet-controlled Capsule Endoscopy: a Prospective Case-control Study.
Condition: Magnet Controlled Capsule Endoscopy
Study type: Observational [Patient Registry]

Summary: 
      During the past several years，MCE（magnet controlled endoscopy）has made great process in
      detecting lesions of gastric as well as screening. Compared with conventional endoscopy,
      magnetically controlled capsule endoscopy can be further optimized in gastric examination. So
      we make an AI for operators to help improve the quality of MCE and record the mucosa
      visibilty of gastirc.
    

Detailed description: 
      We developed a new artificial intelligence for quality improving during the operation of
      magnet controlled endoscopy. The AI can help operators screen every part of gastric and then
      evaluate the visibilty of gastic. Also, It can be record time of the opration. Other than
      that ,we compared the performancce of AI with experts.
    

Intervention name(s): AI-Box
Intervention type(s): Other
Intervention description(s): AI-box is a system fixed adjacent to magnet controlled capsule endoscopy. Patients who accept the check of magnet controlled capsule endoscopywill be enrolled .
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The patients who acccept the magnet controlled capsule endoscopy with the help of
        "AI-box"will be enrolled.
      
Keywords: Artificial intelligence; Magnet controlled capsule endoscopy
Vitamin D Status and Supplementation in Athletes
Condition: Vitamin D Deficiency
MeSH terms: Vitamin D Deficiency
Study type: Interventional
Phase: Phase 3

Summary: 
      The objectives of this study are 1) to assess the prevalence of vitamin D deficiency in a
      group of sub elite athletes and 2) to identify seasonal changes in vitamin D status and the
      effect that supplementation may have during the course of a year.

      The study is a double blinded parallel study design.
    

Detailed description: 
      Study population: 175 elite/ sub elite athletes, male and female, aged 18-60y, from a variety
      of sport disciplines
    

Intervention name(s): vitamin D
Intervention type(s): Dietary Supplement
Intervention MeSH terms: Vitamin D
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: dose-response study
Quantitative EEG During PSG in Patients With and Without Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Observational

Summary: 
      The purpose of this study is to retrospectively analyze Clinical and Nocturnal
      Polysomnographic Data (Overnight Sleep Studies) in patients with and without Fibromyalgia.

      Fibromyalgia is a pain syndrome associated with dysfunctional sleep, fatigue, frequent
      awakenings, non-refreshing sleep, and alpha frequency intrusions. Quantitative EEG during
      routine Nocturnal Polysomnography can be used to assess Alpha/Delta sleep. Hypothesis: Alpha
      intrusions may be an objective marker for Fibromyalgia and may correlate with current
      clinical American College of Rheumatology Criteria for the diagnosis of Fibromyalgia.
    

Detailed description: 
      This is a Retrospective Study of patients with and without Fibromyalgia seen in private
      practice from Aug 2007-July 2010 who underwent Overnight Sleep Studies (PSG)

      The polysomnographic and clinical data from research subjects with a diagnosis of
      Fibromyalgia will be compared to other subjects' PSG and Clinical data who were also referred
      for Sleep Studies including those with Sleep Apnea, Narcolepsy, Periodic Limb Movement,
      Fatigue, and Insomnia which are standard indications for Overnight Sleep Studies.

      Clinical Data: Clinical Data points will include the following: 1. Research Study Number, 2.
      Age, 3. Gender, 4. Body Mass Index, 5. Epworth Sleepiness Scale (self reported scale on
      Sleepiness), 6. Fatigue Severity Scale (self reported scale on Fatigue, 7. American College
      of Rheumatology (ACR) Criteria for Fibromyalgia, 8. Manual Tender Point Exam (# of
      anatomically specific tender points/18), 9. Medications: Benzodiazepines (Bnz, Bnz ),
      Tricyclic Antidepressants (TCA) and Serotonin Reuptake Inhibitors (SSRIs SNRIs).

      Sleep Study Data Points: The following data points will be captured from Overnight Sleep
      Studies: 1. Total Sleep Time, 2. Sleep Efficiency, 3. Wake After Sleep Onset,
      4.Apnea/Hypopnea Index, 5. Respiratory Distress Index, 6. Periodic Limb Movement Index, 7.
      Periodic Limb Movement Arousal Index, and 8. Quantitative EEG: Delta Event/Alpha Event Ratio.
    

Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Private Sleep Practice
      
Keywords: Fibromyalgia; qEEG; Sleep; Pain
The Effectiveness of a Relaxation Technique on the Quality of Life and Symptoms in People Living With HIV
Condition: HIV
Study type: Interventional

Summary: 
      Quality of life of people living with HIV is strongly affected by the presence of one or more
      symptoms, such as sleep problems, fatigue, muscle pain, anxiety and depressive symptoms.
      Autogenic training has shown positive effects on these symptoms in different populations, but
      there is very little evidence on the effects of this relaxation technique in people living
      with HIV.
    

Detailed description: 
      The aim of this project is to evaluate the effectiveness of a relaxation technique, autogenic
      training, on the quality of life and the physical and psychological symptoms in people living
      with HIV.
    

Intervention name(s): autogenic training
Intervention type(s): Other
Intervention description(s): autogenic training
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: relaxation; quality of life; symptoms; pain; depression; anxiety; sleep problems; fatigue
A VI-0521 Study to Evaluate the Long-term Safety and Efficacy in Type 2 Diabetic Adults
Condition: Diabetes
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to determine the long-term safety and efficacy of VI-0521
      (phentermine/topiramate) compared to placebo in providing blood sugar control in Type 2
      diabetic adults. Continuation of initial 6 month trial.
    


Intervention name(s): Phentermine/Topiramate; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): phentermine 15mg/ topiramate controlled release (CR) 92mg, oral capsule, once daily, 28 weeks; Oral placebo capsules, once daily, 28 weeks
Intervention MeSH terms: Topiramate; Phentermine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Diabetes; Type 2 Diabetes; Diabetes Mellitus; Metabolic Diseases; Glucose Metabolism Disorders; Glycemic Control
Does Protein and Fat Content of Meal Increase Glucose Concentrations
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The study investigated the effects of fat protein counting (CFP) in addition to carbohydrate
      (CARB) counting for calculating prandial insulin dosage on blood glucose profile in patients
      with type 1 diabetes (T1D) on basal-bolus insulin therapy.
    

Detailed description: 
      In this single center, crossover, randomized, controlled study, control meal (SM: standard
      meal using carbohydrate counting method) and three test meals (HPM: high protein meal using
      carbohydrate counting method, HPFM-a: high protein-fat meal using carbohydrate counting
      method and HPFM-b: high protein-fat meal using carbohydrate and fat-protein counting method)
      were compared on postprandial early (0-120 minutes), late (120-240 minutes) and total (0-240
      minutes) glucose response.
    

Intervention name(s): Calculation of insulin dosages for different meals
Intervention type(s): Other
Intervention description(s): Calculation of insulin dosages For CARB counting meals using insulin-carbohydrate ratio for dosing mealtime boluses. For fat protein counting meal ICR and additionally fat-protein unit were used for dosing of mealtime boluses.
Intervention MeSH terms: Insulin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Fat-protein counting; Type 1 diabetes; Postprandial glucose level
A Manufacturing Transfer Study Comparing the Bioequivalence of a Single Oral Dose of Claritin-D 12-Hour Extended Release Tablet From 2 Different Manufactuers Under Fed Conditions in Healthy Adult Subjects
Condition: Clinical Pharmacology
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the bioequivalence of one extended release combination (loratadine 5
      mg/pseudoephedrine sulfate 120 mg) tablet manufactured for Bayer HealthCare LLC by SAG
      Manufacturing, S.L.U. Madrid, Spain (test treatment) to the extended release combination
      (loratadine 5 mg/pseudoephedrine sulfate 120 mg) tablet manufactured for Bayer SA-NV by
      Schering- Plough Labo NV Heist (reference treatment) which is currently marketed in Europe.
    


Intervention name(s): Loratadine + Pseudoephedrine sulfate (Claritin-D, BAY818725) (Manufacturer-SAG); Loratadine + Pseudoephedrine sulfate (Claritin-D, BAY818725) (Manufacturer-Heist)
Intervention type(s): Drug; Drug
Intervention description(s): Oral, Loratadine 5 mg/ pseudoephedrine sulfate 120 mg (x1); Oral, Loratadine 5 mg/ pseudoephedrine sulfate 120 mg (x1)
Intervention MeSH terms: Loratadine; Pseudoephedrine; Ephedrine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Upper respiratory allergy symptoms including congestion
Tolerance of an Oral Nutritional Supplement(ONS)
Condition: Gastro-Intestinal Tolerance
Study type: Interventional

Summary: 
      The objective of this study is to capture information on gastrointestinal tolerance (GI) of
      an oral nutritional supplement containing a new protein blend in healthy children aged ≥ 3 to
      ≤ 10 years.
    


Intervention name(s): Study Oral Nutritional Supplement
Intervention type(s): Other
Intervention description(s): Supplement contains a new protein mix consisting of a blend of milk, soy, and pea protein.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Color Perception in Dentistry (CPD)
Condition: Gender
Study type: Observational

Summary: 
      Visual shade matching (VSM) is the most common procedure to select an adequate shade in
      dentistry. This clinical procedure requires the use of a shade guide, being Vita Classical
      (VC) the most popular among the available guides. VSM is a subjective and inconsistent
      process with many observer related variables (e.g. color deficiency, experience, gender and
      eye fatigue) that can influence on the final color appearance. The gender influence on the
      accuracy of VSM is controversial.

      The purpose of this study is to evaluate the VSM performed by female (F) and male (M)
      students, using VC shade guide, testing the null hypothesis that VSM is not influenced by
      gender.
    

Detailed description: 
      -  Female and male observers will be analyzed.

        -  Human upper central incisors (UCI) will be shade matched to shade tabs from Vita
           Classical (VC) shade guide.

        -  The spectral reflectances from the four UCI and from the 16 VC shade tabs will be
           measured using a spectroradiometer (SP).

        -  Measurements will be performed over a gray background, inside a viewing booth and under
           D65 illuminant (diffuse/0º geometry).

        -  CIELAB coordinates (L*, a* and b*) will be calculated according to CIE D65 illuminant
           and CIE 2º Standard Observer.

        -  Two color difference metrics (CIELAB and CIEDE2000(2:1:1)) will be used to find the best
           option for each UCI, using VC shade guide.

        -  Data will be analyzed using descriptive statistics and McNemar test (α=0.05).
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Dental students from University of Passo Fundo (Brazil) and with some knowledge and
        clinical experience with shade matching will be included in the study.
      
Keywords: color; dentistry; gender
A Research Study of V3381 for the Treatment of Diabetic Peripheral Neuropathic Pain
Condition: Pain; Diabetic Neuropathies
MeSH terms: Neuralgia; Diabetic Neuropathies
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of this study is to investigate the safety and efficacy of an investigational
      drug, V3381, for the treatment of diabetic peripheral neuropathic (DPN) pain (pain in one's
      feet and legs, or even in one's hands and arms, sometimes experienced by people with
      diabetes). An investigational drug is one that is not approved by the United States Food and
      Drug Administration (FDA) and/or Health Canada.
    

Detailed description: 
      Diabetic Peripheral Neuropathic Pain (DPNP) is pain in your feet and legs, or even in your
      hands and arms, sometimes experienced by people with diabetes. Neuropathic pain syndromes are
      much more common than is perhaps generally recognized. Approximately 1% of the population in
      western countries suffers from neuropathic pain. Some clinical conditions are associated with
      a relatively high incidence of neuropathic pain. Approximately 15% of patients with diabetic
      neuropathy have persistent neuropathic pain in the feet, legs and hands.
    

Intervention name(s): V3381; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Pain associated with diabetes Type I or Type II; Neuropathic Pain due to diabetes; Diabetic peripheral neuropathic pain; Pain; Diabetes with burning sensation in the arms and/or legs; Diabetes with tingling sensation in the arms and/or legs; Neuropathic Pain Due to Diabetes Type I or Type II