bioihbjkbjnl/mcl2 huggingface dataset:
Neuropsychological Outcomes of Internationally-Adopted Children Who Are Perinatally-Infected With Human Immunodeficiency Virus
Condition: HIV/AIDS
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional

Summary: 
      Children who are perinatally-infected with HIV are extremely vulnerable to cognitive delays
      and psychiatric disease, and the risk for neuropsychiatric illness is compounded in children
      who are internationally-adopted and may have suffered trauma, abandonment, malnutrition and
      neglect. While cognitive and psychiatric issues have been described in HIV-infected children,
      and even more so in HIV-positive adults, there have been no reports on neuropsychiatric
      interventions that can improve cognitive and psychiatric states in this highly vulnerable
      population. Without these needed data, Pediatric HIV providers have not been able to advocate
      for optimal neuropsychiatric care in perinatally HIV-infected children, let alone those who
      has suffered the additional risk of being internationally adopted. In the proposed study, the
      investigators will report on the neuropsychological profiles and outcomes in a cohort of
      internationally-adopted, perinatally HIV-infected children between ages 6 to 16 years who
      have not previously undergone neuropsychological testing or treatment. Data obtained from
      this study will provide important contributions to the literature by building understanding
      of the complex needs of this population as well as guiding future intervention efforts. The
      investigators predict that intervention efforts aimed at helping educators understand the
      learning and cognitive challenges for many of our patients will guide targeted academic
      supports in the school setting and lead to gains in academic skills. The detailed information
      obtained during the comprehensive neuropsychological assessment and follow-up care will be
      shared with the child's key educators at school so that individualized educational strategies
      can be developed, while maintaining confidentiality regarding the child's HIV status.
    


Intervention name(s): Neuropsychological testing
Intervention type(s): Other
Intervention description(s): Comprehensive neuropsychological assessment and implementation of appropriate support and resources.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: neuropsychological outcomes; HIV/AIDS; international adoption; perinatal infection
Pharmacokinetics of Tranexamic Acid After Oral, Intramuscular or Intravenous Administration: a Prospective, Randomised, Cross-over Trial in Healthy Volunteers.
Condition: Healthy Volunteer Study
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1 study which aims to determine the pharmacokinetics and local and systemic
      tolerance of tranexamic acid in healthy volunteers using a population approach after oral,
      intramuscular or intravenous administration. It will also determine the feasibility of
      measuring tranexamic acid in spots of dry capillary blood.
    

Detailed description: 
      Fifteen healthy volunteers will receive in random order 1 gram of intravenous and
      intramuscular injections and 2 grams of oral tranexamic acid solution. Blood samples will be
      taken at:

        -  T0+ 5min (only for IV route)

        -  T0+30min

        -  T0+1h

        -  T0+2h

        -  T0+3h

        -  T0+4h

        -  T0+5h

        -  T0+6h

        -  T0+8h (only for IM and PO routes)

        -  T0+24h
    

Intervention name(s): Tranexamic Acid 1 gram intravenously; Tranexamic acid 2 grams oral solution; Tranexamic acid 1 gram intramuscular
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Intravenous tranexamic acid crossover to oral and intramuscular arms; Oral tranexamic acid crossover to intravenous and intramuscular arms; Intramuscular tranexamic acid crossover to oral and intravenous arms
Intervention MeSH terms: Tranexamic Acid
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: pharmacokinetics, tranexamic acid
Diagnosis of HIV and Early Antiretroviral Therapy Initiation Among HIV-1 Infected Infants
Condition: HIV Infections; Hiv
MeSH terms: HIV Infections
Study type: Observational

Summary: 
      The purpose of the study is to test the effect of the Alere™ q HIV-1/2 Detect (diagnostic
      assay) on uptake of HIV testing among HIV-exposed infants and young children, and health
      outcomes for HIV-infected infants and young children using a novel POC EID Community Model in
      Zambia. The study will also assess the feasibility of field implementation of this novel
      diagnostic tool and its acceptability among HIV-infected mothers and frontline health
      workers.
    

Detailed description: 
      The purpose of the study is to test the effect of the Alere™ q HIV-1/2 Detect (diagnostic
      assay) on uptake of HIV testing among HIV-exposed infants and young children, and health
      outcomes for HIV-infected infants and young children through a novel POC EID Community Model
      in Zambia. The study will also assess the feasibility of field implementation of this novel
      diagnostic tool and its acceptability among HIV-infected mothers and frontline health
      workers. The knowledge generated from this study will enable the Zambia Ministry of Health
      (MOH) to make informed policy decisions about the implementation and scale up of point of
      care (POC) diagnostic tools for early infant diagnosis and pediatric HIV treatment programs
      in Zambia and the region.
    

Intervention name(s): Alere Q Testing
Intervention type(s): Diagnostic Test
Intervention description(s): Infants of intervention clinics will have heelprick-obtained blood tested by standard of care method (SOC) and Alere™ q HIV-1/2 Detect Test Point of Care testing onsite (i.e. community, household, or facility level). Point-of-care (POC) testing results will be available in 52 minutes. HIV-infected infants, based on the Alere Q test result, will start ART as soon as possible and start routine SOC visits at weeks 2, 4, 8, 12, 16, 20, 24, 36, and 48 post ART-initiation. Study data will be obtained on first 4 routine visits after ART initiation (3 months). Infants will return for results of DBS-based DNA PCR testing. Positive SOC infants remain on ART/study follow-up. Negative POC test/negative SOC infants will attend only routine care visits and continue on HIV prophylaxis per national guidelines. Discordant results require DNA PCR test, with positive results continuing ART, negative results being repeated for confirmation before discontinuation.
Other intervention name(s): Alere™ q HIV-1/2 Detect Test Point-of-Care Testing
Observational model: Other
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        HIV-exposed infants and young children (up to 17 months of age)
      
Keywords: EID HIV; Early Infant Diagnosis; Point of Care; Infant; HIV
Beetroot Juice Doses and Anaerobic Performance
Condition: Anaerobic Exercise; Dietary Supplementations
Study type: Interventional

Summary: 
      The purpose of this study is to examine the effect of varying nitrate doses of beetroot juice
      supplementation on dynamic, multijoint resistance exercise performance in active, trained
      individuals. Performance will be assessed based on parameters including neuromuscular
      efficiency, anaerobic performance capability, oxygen consumption, plasma nitrate/nitrite
      levels, specific muscle tissue biomarkers including lactate, and anthropometric measurements
      of select muscle groups.
    


Intervention name(s): Beet It Sport Shot; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Commercially available concentrated beetroot juice supplement intended for athletes.; Fruit juice cordial containing negligible nitrate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Observational,Prospective Study to Develop and Validate a Prognostic Tool to Optimize Therapy in Patients With HCV G1/4
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis C; Hepatitis C, Chronic; Hepatitis
Study type: Observational

Summary: 
      Primary objective:

      • Develop and validate a tool towards patients with chronic hepatitis C genotype 1 and 4 to
      allow optimize treatment.
    

Detailed description: 
      This Tool:

        1. Predicting the overall impact of prognostic factors (including the new factor of genetic
           polymorphism of the IL28B) on Sustained Viral Response (SVR).

        2. Identify those patients most likely to respond.

        3. Therapy and therefore optimize resources

      The validation tool will check into clinical practice its predictive power (it will consider
      its ability to calibrate and discriminate) and make correct inferences and interpretations of
      the scores obtained when applying.
    

Intervention name(s): Peginterferon alfa-2a; Ribavirin
Intervention type(s): Drug; Drug
Intervention description(s): Treatment as usual clinical practice; Treatment as usual clinical practice
Other intervention name(s): Pegasys; Copegus
Intervention MeSH terms: Ribavirin; Peginterferon alfa-2a
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with chronic hepatitis C genotype 1 and 4 mono-or co-infected with HIV who meet
        the selection criteria described.
      
Biospecimen description: 
      Whole blood
Study to Determine the Efficacy and Safety of a Novel Nicotine Replacement Therapy
Condition: Tobacco Dependence
MeSH terms: Tobacco Use Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess the efficacy and safety of a novel nicotine product
      for continuous abstinence from smoking. Efficacy of product will be evaluated by assessments
      of self-reported abstinence, verified by exhaled carbon monoxide (CO) levels.
    


Intervention name(s): Nicotine Spray; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Nicotine Spray; Placebo to match nicotine spray
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
PK Study of Sotagliflozin in Subjects With Hepatic Impairment
Condition: Hepatic Impairment; Healthy
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the effect of mild, moderate, or severe hepatic impairment on the
      pharmacokinetics (PK) of a single dose of 400 mg sotagliflozin (2 x 200-mg tablets) compared
      with healthy, demographically-matched subjects.
    


Intervention name(s): sotagliflozin
Intervention type(s): Drug
Intervention description(s): single 400 mg dose
Intervention MeSH terms: (2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Plasma Sodium Concentration on Blood Pressure Regulators During Hemodialysis
Condition: Patients With End Stage Renal Disease on Hemodialysis
MeSH terms: Kidney Failure, Chronic
Study type: Interventional

Summary: 
      Intradialytic hypotension (IDH) is a frequent and serious complication that may occur during
      hemodialysis treatment. The investigators and others have shown that the Hemocontrol
      biofeedback system is associated with improved hemodynamic stability. Hemocontrol is a
      technique that guides the patients' blood volume along a pre-set trajectory by continuously
      adjusting the ultrafiltration rate and dialysate conductivity. In a recent pilotstudy, the
      investigators found significantly higher plasma vasopressin levels during the first hour of
      dialysis with Hemocontrol in comparison with standard hemodialysis. Increased vasopressin
      levels may contribute to intradialytic hemodynamic stability during hemodialysis by enhanced
      vasoconstriction. These results, however, did not prove directly that the improved
      hemodynamic stability with Hemocontrol is indeed caused by higher initial plasma vasopressin
      levels. Alternative explanations might be that 1) the higher initial plasma sodium levels
      with Hemocontrol dialysis enhance activity of the sympathetic nervous system directly,
      causing vasoconstriction and thereby improved hemodynamic stability and/or 2) that the higher
      initial plasma levels of sodium in Hemocontrol inhibit the release of nitric oxide by the
      vascular endothelium. Another goal of this study is to investigate whether vasopressin is
      removed with hemodialysis.
    


Intervention name(s): Hemocontrol hemodialysis; Standard hemodialysis
Intervention type(s): Device; Device
Intervention description(s): Each participating patient underwent one standard hemodialysis and one hemodialysis with Hemocontrol in random order, both 4 hours in total duration. The Hemocontrol system guides the patients' blood volume along a predefined ideal relative blood volume trajectory, by continuously adjusting ultrafiltration volume and dialysate sodium concentration.; Each participating patient underwent one standard hemodialysis and one hemodialysis with Hemocontrol in random order, both 4 hours in total duration. During standard hemodialysis, a constant ultrafiltration rate and dialysate conductivity was used.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Hemodialysis, sodium, endothelium, sympathetic activity, vasopressin
¡Salud! Por la Vida (SPLV) A Colorectal Screening Promotion Program
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional

Summary: 
      The overall goal of this educational program was to increase colorectal cancer screening
      (CRCS) in men and women who attend Federally Qualified Health Centers (FQHC) in Puerto Rico.
      FQHCs, referred to in Puerto Rico as "Clínicas 330", are ideal settings to implement
      innovative approaches to increase CRCS because they serve primarily low-income patients who
      typically have lower rates of screening. The goal of this study, is to develop and evaluate
      the impact of a clinic level intervention on increasing CRCS among low-income Puerto Rican
      men and women aged 50-75, who have either never been screened for colorectal cancer, or are
      under-screened according recommended guidelines. To evaluate the delivery of the CRCS
      education program we used a group randomized controlled trial that provided data to determine
      the effectiveness of the CRC intervention program compared with usual practice (no
      intervention).
    


Intervention name(s): ¡Salud! Por la Vida
Intervention type(s): Behavioral
Intervention description(s): Lay health worker (LHW) delivered educational intervention for colorectal cancer screening (CRCS). The intervention consisted in having the participant complete a tailored interactive multimedia intervention (TIMI). TIMI consisted of a series of educational videos that addressed common barriers to colorectal cancer screening as well as provided information about colorectal cancer (CRC) and CRCS tests. Participants were able to tailor the TIMI for sex (male/female) and CRC family history. After TIMI completion, the LHW provided participant with a copy of the SPLV newsletter and printed infographics on CRC, CRCS, and an action plan tailored by type of CRCS (FOBT/FIT or colonoscopy). The Intervention Group subject participation took approx. up to 2 hours and Control Group up to 1 hour (half hour for each: baseline and follow-up interview). Follow-up data was collected 6 months post education session (intervention group) or post-baseline survey (control group).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Hispanic/Latino; Behavioral Intervention; Lay Health Workers; Colorectal cancer; Colorectal cancer screening; Colonoscopy; cancer prevention
Brain Blood Flow: Age and Gender
Condition: Healthy; Aging
MeSH terms: Hypercapnia
Study type: Observational

Summary: 
      Baseline cerebral blood flow through the middle cerebral artery (MCA) and cerebral
      vasodilator response of the MCA to inhaled carbon dioxide (CO2) will be measured in young
      women, young men, older women, and older men using Magnetic Resonance (MR) imaging and
      transcranial Doppler ultrasound (TCD). Data collection techniques will be compared.
    

Detailed description: 
      The investigators have recently shown that cerebral blood flow responses to chemical stimuli
      are reduced in healthy older adults. The investigators also have preliminary data suggesting
      that sex differences in cerebrovascular regulation exist. The overall goal of this
      application is to extend on the investigators previous studies by employing advanced
      neuroimaging techniques to enhance the investigators understanding of neurovascular coupling
      in healthy aging. This study will collect clinically significant data with implications for
      the future risk of cognitive decline and Alzheimer's disease.

      The research aims are:

        1. To determine the effect of age and sex on baseline cerebral blood flow through the
           middle cerebral artery (MCA).

        2. To determine the effect of age and sex on cerebral vasodilator responses.

        3. To determine if the cerebrovascular responses measured by transcranial Doppler
           ultrasound (TCD) are associated with the cerebrovascular responses measured by Magnetic
           Resonance (MR) imaging.
    

Intervention name(s): MRI; TCD
Intervention type(s): Device; Device
Intervention description(s): Participants will undergo a MRI scan while two stepwise CO2 elevations are applied to the participant by adding fractional concentration of inspired CO2 (FICO2) at 4% and 6% each time. The end tidal CO2 (PetCO2) will be elevated and maintained constant for a few minutes at each target level. Breath-by-breath changes in respiratory rate and PetCO2 will be measured.; Participants will undergo a TCD scan while two stepwise CO2 elevations are applied to the participant by adding fractional concentration of inspired CO2 (FICO2) at 4% and 6% each time. The end tidal CO2 (PetCO2) will be elevated and maintained constant for a few minutes at each target level. Breath-by-breath changes in respiratory and PetCO2 will be measured.
Other intervention name(s): Magnetic Resonance Imaging; Transcranial Doppler Ultrasound
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects for this study will include healthy young adults (20-34 years old) and healthy
        older adults (50-69 years old). Both men and women will be eligible to participate in this
        study.
      
Keywords: Magnetic Resonance Imaging; Transcranial Doppler Ultrasound; Hypercapnia
Feasibility of Integrating Indirect Calorimetry (IC) Technology in Primary Care
Condition: Obesity; Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the feasibility of using indirect calorimetry (IC)
      within a comprehensive weight reduction program. Will individuals that receive a personalized
      nutrition program, at baseline, from IC technology respond better to treatment compared to
      individuals receiving IC technology at three months.
    


Intervention name(s): Individualized IC treatment; Usual Care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Individuals will receive IC measurement at baseline and three months. Nutrition and physical activity plan will be developed and adjusted from measured RMR and lifestyle.; Individuals will receive standard dietary plan. Women will receive 1200 Kcal/day and men will receive 1600 Kcal/day. Individuals will receive RMR measurement at three months. RMR information will be used to help improve eating behavior.
Other intervention name(s): MedGem indirect Calorimeter; MedGem indirect Calorimeter
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Effect of Eye Movement on Toric Lens Orientation and Visual Acuity
Condition: Astigmatism
MeSH terms: Astigmatism
Study type: Interventional

Summary: 
      The relative performance of a new toric soft contact lens against toric contact lenses
      currently available in market, specifically for visual acuity and lens orientation. The study
      will be conducted in a staged approach (2 stages).
    

Detailed description: 
      Non-dispensing, single-masked (subject-masked), randomised, controlled study. Two visits.
    

Intervention name(s): senofilcon A; balafilcon A; omafilcon A; lotrafilcon B
Intervention type(s): Device; Device; Device; Device
Intervention description(s): toric contact lens; toric contact lens; toric contact lens; toric contact lens
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: astigmatism; visual acuity; orientation; contact lenses
Supine Position for Colonoscopy Insertion
Condition: Colonoscopy Insertion; Patient Position
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether the supine position is better than the left
      lateral horizontal body position to decrease cecal intubation time, patients' pain and the
      difficulty of colonoscopy insertion.
    

Detailed description: 
      Left lateral position is conventionally performed to initiate colonoscopy, yet no evidence
      has demonstrated its efficacy and advantages. Left lateral position for insertion, which
      results in air rising away from the left colon and producing acute bends in the sigmoid,might
      increase the risk of colonoscopy loop formation.When there is difficulty advancing the
      colonoscope, supine position can be employed to ensure cecal intubation. Therefore, we
      perform a randomized controlled trial to compares supine position with left lateral position
      for the safety and efficacy of colonoscopy insertion.
    

Intervention name(s): supine position
Intervention type(s): Procedure
Intervention description(s): patients were positioned on their supine position to receive colonoscopy insertion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment