bioihbjkbjnl/mcl2 huggingface dataset:
Prevalence, Characteristics and Risk Factors of HIV-Associated Neurocognitive Disorders in Subjects Between the Ages of 55 and 70 Years: An Exposed/Unexposed Cross Sectional Study
Condition: HIV-1 Infection
MeSH terms: Neurocognitive Disorders
Study type: Interventional

Summary: 
      The primary objective is to measure the prevalence of according to the Frascati
      classification in a HIV-infected population aged between 55 and 70 years (exposed group) and
      to compare it with the prevalence of HIV-Associated Neurocognitive Disorders (HAND) in
      unexposed subjects from the general population-based cohort CONSTANCES, matching subjects on
      age, gender, geographical origin and socioprofessional category.
    

Detailed description: 
      Secondary objectives are:

        -  To study factors associated with Asymptomatic Neurocognitive Impairment (ANI) or Mild
           Neurocognitive Disorders (MND) by distinguishing the impact of traditional risk factors
           of neurocognitive impairment and those related to HIV infection,

        -  To compare in the exposed and unexposed population physical characteristics, complaints
           and comorbidities,

        -  To compare global neurocognitive scores in both populations after standardized normal
           reduction of each test.

      Methodology:

      HIV-infected subjects aged between 55 and 70 years will be recruited in centres that support
      people who living with HIV usually. The study will be proposed consecutively to all subjects
      aged between 55 and 70 year. A brief inquiry will collect motives on subjects that refuse to
      participate. A minimum of 70 subjects by 5 years age categories will be included. Unexposed
      subjects will be recruited in the same regions as their HIV-infected counterparts from the
      CONSTANCES database, a general population health cohort, after random selection matched on
      age, gender, geographical origin and socioprofessional category (2 HIV-unexposed subjects for
      1 exposed subject). Data collection will follow the same methods as in the CONSTANCES cohort,
      in particular the neurocognitive tests by trained neuropsychologists.
    

Intervention name(s): Health related quality of life and social and demographic informations; Neurocognitive assessment; cerebral images sub-study
Intervention type(s): Other; Other; Radiation
Intervention description(s): At the inclusion visit with a self-assessment questionnaire; At the neurocognitive visit, with standard test as CONSTANCES cohort; Standard magnetic resonance imaging
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Dapagliflozin Efficacy and Action in PCOS
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess the efficacy and safety of dapagliflozin on improving
      insulin resistance and hyperandrogenemia in obesity women with polycystic ovary syndrome.
    


Intervention name(s): Dapagliflozin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive dapagliflozin 10mg po qd. Additionally, participants will receive lifestyle modification and nutrition education.; Participants will receive placebo po qd. Additionally, participants will receive lifestyle modification and nutrition education.
Intervention MeSH terms: Dapagliflozin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Polycystic Ovary Syndrome; SGLT2 inhibitor
Energy Expenditure Methodology Infant
Condition: Healthy
Study type: Observational

Summary: 
      Indirect calorimetry is valuable in determining resting energy expenditure in infants,
      children and adults. This measure will estimate the number of calories needed per day under
      resting conditions.

      Adding physical activity measures will help estimate total energy requirements in
      individuals. With the rise in obesity, numerous programs of prevention are being developed.
      Being able to characterize carefully energy intake and energy expenditure is one of the
      challenges of most of these initiatives.
    


Intervention name(s): No intervention
Intervention type(s): Device
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy infants
Membrane Blue Versus Infracyanine Green
Condition: Macular Pucker; Macular Hole
MeSH terms: Retinal Perforations; Epiretinal Membrane
Study type: Observational

Summary: 
      To compare possible toxicities of membrane blue and infracyanine green in vivo by macular
      function and peripheral visual field.
    


Time perspective: Prospective
Study population: 
        Patients with a macular pucker or a macular hole, without any other retinal disease
      
Keywords: Macular pucker; Macular hole; Membrane Blue; Infracyanine Green; Peripheral Visual Field
A Study of Ascending Multiple Doses of Oral Surotomycin in Healthy Participants (MK-4261-009)
Condition: Clostridium Difficile Associated Diarrhea (CDAD)
MeSH terms: Diarrhea
Study type: Interventional
Phase: Phase 1

Summary: 
      This study aims to assess the safety, tolerability, and pharmacokinetics (PK) of oral doses
      of surotomycin (CB-183,315) administered for 14 consecutive days in healthy males and
      females.
    


Intervention name(s): Surotomycin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Two oral doses of surotomycin in hard gelatin capsules totaling either 0.5, 1 or 2 g per day, for 14 days; Two oral doses of placebo for surotomycin in hard gelatin capsules per day, for 14 days
Other intervention name(s): CB-183,315
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Evaluation of Chlorhexidine Gluconate Concentration on Skin of Human Subjects Following Multiple Application Times
Condition: General Skin Cleansing
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will evaluate the amount of chlorhexidine gluconate (CHG) present on treated skin
      of human volunteers following different application times with a test material bathing
      system. The amount of recovered CHG that resides on the skin following each of the evaluated
      application times will be evaluated via high performance liquid chromatography with
      ultraviolet detection (HPLC-UV) and correlated with the MIC values determined separately.
    


Intervention name(s): Chlorhexidine Gluconate with HUBS
Intervention type(s): Combination Product
Intervention description(s): 4% CHG soap will be applied to HUBS following manufacturers recommendation and applied to skin for different application times as dictated by the randomization of the marked sites on the forearm. Followed by a HUBS moistened with water.
Intervention MeSH terms: Chlorhexidine; Chlorhexidine gluconate
Intervention model: Single Group Assignment
Intervention model description: Volunteer forearms will be marked with 6 test sites which will be randomly assigned a time point for the application.
Masking: None (Open Label)
Primary purpose: Other
Evaluation of a Cincalcet Suppression Test
Condition: Parathyroid Hormone Suppression Test With Cinacalcet
MeSH terms: Vision Disorders; Hyperparathyroidism
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of the study is to compare the results of a parathyroid hormone (PTH)suppression test
      using a single oral tablet of cinacalcet in two groups of subjects: 1- a group of healthy
      adults in whom the results of the test with cinacalcet will be compared with those of the
      standardized PTH suppression test with intravenous calcium loading; 2- a group of patients
      with proven primary hyperparathyroidism in whom the results of the test with cinacalcet will
      be compared with those obtained during the same test, in healthy controls.
    


Intervention name(s): cinacalcet; cinacalcet dose 1; cinacalcet dose 2
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Intake of a single tablet of cinacalcet; PTH suppression test in primary hyperparathyroidism using cinacalcet (dose 1).; Parathyroid hormone suppression test in primary hyperparathyroidism using cinacalcet (dose 2).
Intervention MeSH terms: Cinacalcet
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Parathyroid hormone; Cinacalcet; Primary hyperparathyroidism; Diagnosis
Fat Reduction in the Submandibular/Submental Area
Condition: Body Fat Disorder
MeSH terms: Lipid Metabolism Disorders
Study type: Interventional

Summary: 
      The purpose of this study is to further evaluate the safety and efficacy of non-invasive
      reduction of subcutaneous fat in the submental and submandibular area using Cryolipolysis.
    


Intervention name(s): The ZELTIQ CoolSculpting System
Intervention type(s): Device
Intervention description(s): The CoolSculpting device will be used to perform the treatments.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Non Opioid Treatment for Experimental Dyspnea
Condition: Dyspnea; Pain
MeSH terms: Dyspnea
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this protocol is to test the effects of the non opioid nefopam on experimental
      dyspnea and on the counterirritation (ie inhibition of one pain by another pain) induced by
      dyspnea in healthy subjects.
    

Detailed description: 
      Dyspnea and pain share many features. One of them is the counterirritation phenomenon:
      defined in pain research as the attenuation of one pain by another pain. Dyspnea induced with
      inspiratory threshold loading (increased sense of work/effort ) has been shown to attenuate
      electrical pain as shown through nociceptive flexion reflex inhibition, or thermal pain, as
      measured with cortical evoked responses (laser evoked potentials-LEP).

      The investigators will study whether nefopam modulates the counterirritation of laboratory
      induced dyspnea in healthy subjects. The effect of nefopam on experimental dyspnea will be
      measured with a visual analog scale (VAS) and a validated multidimensional dyspnea profile
      (MDP). The effect of treatment on counterirritation will be measured by recording LEP
      obtained using a CO2 laser system. The amplitude of the N2-P2 component of the LEP is the
      main study outcome.
    

Intervention name(s): Nefopam
Intervention type(s): Drug
Intervention description(s): Subjects will be infused intravenously with nefopam (20mg/2mL) over a course of 30 minutes in a supine position. There will be a single administration of IV 20 mg nefopam and IV placebo. Each intervention will occur on a separate day.
Other intervention name(s): acupan
Intervention MeSH terms: Nefopam
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Dyspnea; Pain
Pulmonary Function at Presentation and Follow-up in Hemato-Oncology 3-7 Years Old Children
Condition: Acute Lymphoblastic Leukemia; Acute Myeloblastic Leukemia; Solid Tumors,; Hodgkin's Disease; Non-Malignant
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid; Hodgkin Disease; Leukemia, Myeloid, Acute
Study type: Observational

Summary: 
      The aim of this study was to investigate the occurrences of respiratory symptoms risk factors
      and abnormalities in lung function in young children (3-6 years old) with hemato-oncologic
      diseases at presentation (before treatment) and up to 3 years follow-up (study period).
    

Detailed description: 
      Pulmonary function tests (PFTs) are a part of the routine follow-up of patients receiving
      anti-cancer treatment. Treatment is frequently associated with diverse pulmonary damage which
      may become functionally and clinically evident many years later. PFTs may help to quantify
      the damage in the lungs; help to evaluate the point at which lung function deviates from
      normal to allow early intervention before irreversible lung damage occurs and thereby to
      reduce morbidity and mortality.

      Reliable PFTs in the preschool age have traditionally been difficult to perform, but recent
      publications have demonstrated that the majority of preschool children can produce
      reproducible forced expiratory flow volume (FEVC) curves with proper coaching techniques.
      This recent development may enable studying the long term effect (years) of treatment on lung
      function in young children suffering from hemato-oncologic diseases.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        All pediatric patients (age 3-7 years) with hemato-onclogic diseases that were treated at
        the Hemato-Oncology Department, and were sent to the pediatric pulmonary unit at the Safra
        children's hospital, Sheba medical center, Ramat-Gan, Israel, to perform lung function
        tests, as a part of a 3-year follow-up study.
      
Keywords: acute lymphoblastic leukemia; long-term lung function
UARK 2013-05 A Study of Autologous Expanded Natural Killer Cell Therapy for Asymptomatic Multiple Myeloma
Condition: Asymptomatic Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell; Smoldering Multiple Myeloma
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the safety and in vivo persistence and expansion of
      autologous and expansion of autologous, ex vivo expanded-natural killer(ENK) cells.
    

Detailed description: 
      To determine whether significant in vivo expansion of auto-ENK cells occurs, defined as a > 4
      fold increase in absolute cluster of differentiation 3(CD3)-cluster of differentiation 56
      (CD56+) NK cell count/blood 7 days after infusion over the pre-study baseline level and the
      safety of the ENK cell therapy in research participants with high-risk asymptomatic multiple
      myeloma (AMM) defined as gene expression profile (GEP) 70 gene score>-0.26.
    

Intervention name(s): ENK Cell Infusion
Intervention type(s): Drug
Intervention description(s): Day 0(1 dose) ENK Cell Infusion Day 0 to + 12 (13 doses) Aldesleukin (IL2), 3x10 IU
Other intervention name(s): Auto-ENK Cell Therapy
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Asymptomatic Multiple Myeloma; Auto-ENK Cell Therapy; Natural Killer Cells
Dose Escalation Trial of CM310 in Patients With Moderate-to-Severe Atopic Dermatitis (AD)
Condition: Moderate-to-severe Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a multi-center, randomized, double blind, placebo-controlled multiple dose escalation
      study to evaluate the safety, tolerance, PK, PD, immunogenicity and preliminary efficacy of
      subcutaneously CM310 in moderate-severe AD subjects.
    

Detailed description: 
      The study consists of 3 periods, a up-to-4-week Screening Period, a 4-week randomized
      Treatment Period and a 8-week Safety Follow-up Period.
    

Intervention name(s): CM310; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): IL-4Rα monoclonal antibody; Placebo
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Iplasma IL6, Procalcitonin and VEGF and Dialysate Level in CAPD Patients
Condition: Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Observational

Summary: 
      The aim of study was to evaluated the correlation between plasma levels, dialysate appearance
      rate of VEGF, inflammatory cytokines (IL- 6, procalcitonin) and PSTR, dialysis adequacy in
      CAPD patients.
    

Detailed description: 
      This cross -sectional study measured IL-6, procalcitonin and VEGF level in plasma and
      overnight effluent. PSTR of small solutes was evaluated by standard peritoneal equilibration
      test (standard PET). Weekly Kt/V and creatinine clearance (CCr ) were evaluated in all
      patients.
    

Intervention name(s): Measure plasma and dialysate level of IL-6, procalcitonin and VEGF
Intervention type(s): Other
Intervention description(s): correlation between plasma levels, dialysate appearance rate of VEGF, inflammatory cytokines (IL- 6, procalcitonin) and PSTR, dialysis adequacy in CAPD patients.
Intervention MeSH terms: Dialysis Solutions
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        CAPD patients age more than 18 years
      
Keywords: CAPD; Peritoneal solute transport rate; Dialysis adequacy
Geko Venous Leg Ulcer Study
Condition: Venous Leg Ulcer
MeSH terms: Varicose Ulcer; Leg Ulcer; Ulcer
Study type: Interventional

Summary: 
      This study is designed to look at the effect of the geko device on the circulation in lower
      limbs of participants with venous leg ulcers.
    


Intervention name(s): geko
Intervention type(s): Device
Intervention description(s): neuromuscular electrostimulator
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Efficacy, Safety of Hypertonic Lactate Soln. as Fluid Resuscitation Compared With Ringer's Lactate in Post-CABG Pats
Condition: Low Cardiac Output
MeSH terms: Cardiac Output, Low
Study type: Interventional
Phase: Phase 3

Summary: 
      Prospective, randomized, open-label study to assess the efficacy and safety of hypertonic
      lactate solution, compared to Ringer's Lactate as fluid resuscitation to maintain hemodynamic
      stability in post-coronary artery bypass grafting(CABG) patients. Patients who were eligible
      received either hypertonic lactate solution or Ringer's Lactate post-CABG in the ICU when
      fluid resuscitation was needed.
    

Detailed description: 
      Prospective, randomized, open-label study to assess the efficacy and safety of hypertonic
      lactate solution, compared to Ringer's Lactate as fluid resuscitation to maintain hemodynamic
      stability in post-coronary artery bypass grafting(CABG) patients. Patients who were eligible
      received either hypertonic lactate solution or Ringer's Lactate post-CABG observed in the
      first 12 hours in the ICU when fluid resuscitation was needed.
    

Intervention name(s): Hypertonic lactate; Ringer's lactate
Intervention type(s): Drug; Drug
Intervention description(s): Parenteral solution administered to a maximal volume of 10 ml/kg BW over the first 12 hours post-CABG; Parenteral solution administered to a maximal dose of 30 ml/kg BW over the first 12 hours post-CABG
Other intervention name(s): Totilac
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: coronary; artery; bypass; grafting; I.V.; cardiac output
Evolution of Molecular Biomarkers in Acute Heart Failure Induced by Shock
Condition: Acute Heart Failure; Shock
MeSH terms: Heart Failure; Shock
Study type: Observational

Summary: 
      The relationship between shock, ischemia and reperfusion (I/R) injury, hemodynamic
      instability, systemic inflammatory response syndrome and multiorgan failure has been
      extensively investigated, but there is no consensus on the trigger mechanisms of tissue
      injury at the molecular level.

      Current therapies are targeted to reduce symptoms of shock and multiorgan damage but they are
      unable to act at the "beginning of the cascade", because of the lack of a model explaining
      the molecular basis of shock induced tissue injury and ensuing organ damage.

      The present observational study is aimed at identifying the molecular triggers of acute heart
      failure (HF) induced by shock and to identify inflammatory mediators and markers that are
      activated in shock, with a particular emphasis on the role of uncontrolled proteolytic
      activity.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        All the patients admitted to ICU
      
Biospecimen description: 
      whole blood, serum
    
Keywords: shock; heart failure; inflammation; biomarkers; cardiovascular instability; metabolic pathways; proteolysis
Effect of Pioglitazone on Cardiovascular Outcome on Higashi-Saitama Trial in Patients With Type 2 Diabetes
Condition: Type 2 Diabetes; Hypertension; Dyslipidemia; Diabetic Nephropathy
MeSH terms: Diabetic Nephropathies; Diabetes Mellitus, Type 2; Dyslipidemias
Study type: Observational

Summary: 
      We want to investigate the effects of pioglitazone on cardiovascular events in Japanese
      patients with type 2 diabetes.
    

Detailed description: 
      Primary composite endpoints:

      Cardiovascular death Non-fatal myocardial infarction and angina Non-fatal stroke Renal
      failure (hemodialysis/doubling of serum creatinine)

      Secondary endpoints:

      urinary albumin excretion diabetic retinopathy hyperlipidemia hypertension gout
    

Intervention name(s): pioglitazone
Intervention type(s): Drug
Intervention MeSH terms: Pioglitazone
Observational model: Defined Population
Time perspective: Prospective
Prostaglandin E2 in Migraine Suffers Without Aura.
Condition: "Migraine-like" Headache
MeSH terms: Migraine Disorders; Headache
Study type: Interventional

Summary: 
      The hypothesis of this study is that Prostaglandin E2 (PGE2) induces headache and dilatation
      of brain vessels in migraine patients without aura.
    


Intervention name(s): dinoprostone; isoton sodium chloride
Intervention type(s): Drug; Drug
Intervention description(s): intravenous injection 0.4 μgr/kg/min for 25 min; intravenous injection for 25 min
Other intervention name(s): Prostin E2; placebo
Intervention MeSH terms: Dinoprostone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
The Effect of Message Framing on Blood Donation-Study 2
Condition: Rh Negative Blood Donor
Study type: Interventional

Summary: 
      Rh negative blood group is a rare blood group in China, as it only accounts for 0.3-0.4
      percent of the Han population. Therefore, low inventory is often found in blood collection
      and supply agencies in many regions in China. In order to assess the effects of the
      gain-versus-loss framing message on blood donation among Rh negative donors, we designed two
      kinds of self-administered, standardized and structured questionnaires. In addition of the
      basic socio-demographic characteristics, one questionnaire includes the questions which
      survey the attitude of saving patients lives, and the other was to survey the attitude of
      preventing patients from death. The questionnaires were randomly sent to Rh negative blood
      donors.
    


Intervention name(s): Gain-frame questionnaire; Loss-frame questionnaire
Intervention type(s): Other; Other
Intervention description(s): Questionnaires focusing on the attitude of saving patients' lives were given to Rh negative blood donors in this group.; Questionnaires focusing on the attitude of preventing patients from death were given to Rh negative blood donors in this group.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research