bioihbjkbjnl/mcl2 huggingface dataset:
Environmental Influences on Vitamin D Status
Condition: Vitamin D Deficiency
MeSH terms: Vitamin D Deficiency
Study type: Observational

Summary: 
      Vitamin D deficiency is a common problem. The principal source of vitamin D for humans is
      solar exposure, with cutaneous synthesis of vitamin D by photoconversion of
      7-dehydrocholesterol in the skin to pre-vitamin D3. Latitude, altitude, season, skin
      pigmentation, and age are recognized factors that influence how much vitamin D can be made by
      solar exposure. However, the relative influences of each are largely unknown and we cannot
      reliably answer the question of how much sun exposure an individual needs at various
      latitudes and at various seasons in order to ensure normal vitamin D status.
    

Detailed description: 
      Purpose of the study: To determine the effect of environmental influences on Vitamin D
      status.

      Specific Aims

        1. To measure the prevailing 25D and Vitamin D levels in communities at diverse latitudes
           (Alaska and Hawaii).

        2. To collect information on variables that influence Vitamin D status such as skin color,
           history of sun exposure and sunscreen use, diet history, vitamin and calcium supplements
           used, and BMI.

        3. To collect typical food samples from the region for future analysis of their Vitamin D
           and 25D content.

        4. To collect a blood sample for DNA analysis of inter-individual differences in Vitamin D
           metabolism (Gc or Vitamin D binding protein alleles).
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Age of Subjects: The subjects will be between ages 18-60. The upper age is limited to age
        60 as aging skin is less able to make vitamin D, therefore a separate study of elderly
        people would be more appropriate.

        Racial and Ethnic Origin: Both sites have a diverse ethnic and racial population and the
        subjects will be as representative of the population as possible.
      
Keywords: Vitamin D; Sun; Latitude; Vitamin D status
New Health Devices to Improve Adherence to Physical Activity in Overweight Inactive Adults
Condition: Cardiovascular Diseases; Obesity
MeSH terms: Cardiovascular Diseases; Overweight
Study type: Interventional

Summary: 
      The purpose of this study is to test in overweight and inactive adults whether the new PAI
      eHealh APP leads to better adherence to a physical activity regimen than the wearable step
      counter App from the market leader FitBit, and to evaluate if improved adherence will be
      reflected in a better cardiovascular profile in this group.
    


Intervention name(s): Pai APP; FitBit APP
Intervention type(s): Device; Device
Intervention description(s): prescribed 100 PAI weekly; prescribed 10000 steps daily
Other intervention name(s): personal activity Intelligence (PAI) application; Mio Fuse wristband; FitBit zip step counter
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: healthy volunteers; patient compliance; exercise; motivation
Remote Neurocognitive and Psychological Assessment in PKU
Condition: Phenylketonurias
MeSH terms: Phenylketonurias
Study type: Observational

Summary: 
      PKU is a rare autosomal recessive condition associated with disruption in dopamine synthesis.
      Although early diagnosis and treatment prevent the severe impairments associated with
      untreated PKU, individuals with early-treated PKU (ETPKU) nonetheless experience significant
      sequelae, including impaired working memory and increased risk for anxiety problems. Past
      research with other clinical populations (e.g., generalized anxiety disorder) suggests that
      the two phenomena may be linked, with increased anxiety contributing to poorer WM
      performance. Currently we propose to initiate an exciting new line of research examining the
      potential relationship between anxiety and WM in ETPKU. The proposed study will also apply
      remote neuropsychological performance-based assessment to the study of ETPKU and thus
      overcoming the geographical limitations/challenges associated with recruitment of
      participants with this rare disease.
    


Intervention name(s): nointervention
Intervention type(s): Other
Intervention description(s): Nointervention
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Individuals age 18-40 years old with and without PKU
      
Biospecimen description: 
      Blood phe levels
Anti-FLEX: Flexed Levering of Gluteal Vessels
Condition: Healthy
Study type: Observational

Summary: 
      The purpose of this study is to evaluate the effect of the gluteal vasculature in the prone
      and jackknife positions.
    

Detailed description: 
      This is a prospective collection of contrast-enhanced CT images of healthy female volunteers
      in prone and jackknife positions in order to determine if position impacts gluteal venous
      vasculature.
    

Intervention name(s): CT imaging
Intervention type(s): Diagnostic Test
Intervention description(s): Contrast-enhanced CT imaging of the pelvis in prone and jackknife positions
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Healthy volunteers who will undergo contrast-enhanced CT imaging of the gluteal venous
        vasculature in the prone and jackknife positions
      
Keywords: gluteal venous vasculature; prone position; jackknife position
No-worry Baby Project
Condition: Gestational Diabetes Mellitus in Pregnancy; Gestational Hypertension; Thyroid Disease Pregnancy; Obesity; Anemia in Pregnancy; Complications, Pregnancy; Depression; Obstetric Labor Complications; Asthma; Allergic Disorder; Immune System Diseases; Neurodevelopmental Disorders; Reproductive Disorder
MeSH terms: Diabetes, Gestational; Hypertension, Pregnancy-Induced; Obstetric Labor Complications; Pregnancy in Diabetics; Pregnancy Complications; Thyroid Diseases; Immune System Diseases; Hypersensitivity; Neurodevelopmental Disorders
Study type: Observational

Summary: 
      The Huizhou mother-infant cohort was set up to investigate the effect of dietary factors and
      environmental exposures during pregnancy on health consequences of mothers and offsprings in
      Huizhou, China.
    

Detailed description: 
      Huizhou mother-infant cohort (No-worry Baby Project) is a scientific research/public health
      project jointly initiated by Huizhou First Maternity and Child Healthcare Hospital and School
      of Public Health, Sun Yat-sen University. The project plans to recruit 10,000 participants
      since early pregnancy and follow up for three years after birth in the first stage.
      Biological samples, data from questionnaires survey and clinical information will be
      collected for both mothers and infants. The study is aimed to investigate the effects of
      dietary factors and environmental exposures during pregnancy on infants' health as well as
      the prognosis of diseased mothers. The study will have essentially both clinical and public
      health implications to find effective strategies for prevention and management of a range of
      chronic disorders (above mentioned) during pregnancy and exploration of the possible impacts
      on offspring health. The cohort will provide scientific basic for improvement of mother and
      infant's health.
    

Intervention name(s): No intervention
Intervention type(s): Other
Intervention description(s): No intervention
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Eligible pregnant women will be recruited from Huizhou First Maternal and Child Care
        Service Center.
      
Biospecimen description: 
      During pregnancy: maternal vein blood at mid- and last trimester, spot and 12-hr urine and
      feces at mid-trimester; At delivery: umbilical cord blood, placenta , umbilical cord,
      mother's milk. Postnatal: mother's vein blood During infancy: meconium. During childhood:
      Mother's milk and baby's feces.
CardioQ vs Thermodilution Measurements of Cardiac Output
Condition: Comparison of CardioQ and Thermodilution Derived Cardiac Output Measurements
Study type: Interventional

Summary: 
      Minimal invasive monitoring systems of central hemodynamics are gaining increasing
      popularity. The present study investigates the precision of the esophageal doppler (CardioQ)
      derived cardiac output and its agreement with pulmonary artery catheter thermodilution (PAC
      TD) for measuring CO during steady state and with induced hemodynamic changes in patients
      scheduled for elective cardiac surgery.
    

Detailed description: 
      Twenty-five patients are planned to be enrolled. After induction of anesthesia, insertion of
      the PAC and the esophageal-doppler probe, the patient are placed in the following successive
      positions: a) supine, b) head-down tilt, c) head-up tilt, d) supine, e) supine with
      phenylephrine administration f) pace heart rate 80 bpm, g) pace heart rate 110 bpm, and CO
      are measured simultaneously using the CardioQ and PAC TD.
    

Intervention name(s): induced changes in hemodynamics
Intervention type(s): Other
Intervention description(s): Twenty-five patients are planned enrolled. After induction of anesthesia, insertion of the PAC and the CardioQ probe, the patient are placed in the following successive positions: a) supine, b) head-down tilt, c) head-up tilt, d) supine, e) supine with phenylephrine administration f) pace heart rate 80 bpm, g) pace heart rate 110 bpm. CO are measured simultaneously using the TEE and thermodilution technique.
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Diagnostic
Keywords: cardiac output; thermodilution; esophageal doppler; trending ability
A Pilot Study to Evaluate the Efficacy of Ariva® Silver Wintergreen, a Smoking Aversive Lozenge
Condition: Tobacco Use Disorder; Smoking
MeSH terms: Tobacco Use Disorder
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a study to determine the safety and effectiveness of silver salt in Ariva® Silver
      Wintergreen Lozenge on discouraging smoking, by its imparting an unfavorable taste to the
      smoker when tobacco is smoked.
    

Detailed description: 
      Each subject will be given an Ariva® Silver Wintergreen lozenge or a Placebo Wintergreen
      lozenge on a random basis.

      Once the lozenge has dissolved in the mouth, subjects will smoke one of their own cigarettes,
      and will answer questions about the experience and their craving for a cigarette.

      After a washout period, each subject will repeat the steps with the second type of lozenge.
    

Intervention name(s): Ariva Silver Wintergreen; Placebo Wintergreen
Intervention type(s): Other; Other
Intervention description(s): Study product containing 6 mg silver salt and 2 mg nicotine per dissolvable lozenge, administered orally as a single dose.; Placebo Wintergreen lozenge containing no tobacco, nicotine, or silver salt, administered orally as a single dose.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: smoking; smokeless; aversion; nicotine; nicotine replacement
The Effect of Tinnitus Retraining Therapy on Subjective and Objective Measures of Chronic Tinnitus
Condition: Tinnitus
MeSH terms: Tinnitus
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to examine the efficacy of tinnitus retraining therapy (TRT)
      as a treatment of chronic tinnitus in people with limited hearing loss. The study design is
      prospective, randomized, double-blind, with repeated measures. The null hypothesis states
      there will be no difference in subjective measures of tinnitus severity between subjects
      treated with standard TRT and subjects treated with sham TRT.
    

Detailed description: 
      The specific aims of the study are to:

        -  Evaluate the efficacy of TRT in reducing the objective magnitude of tinnitus.

        -  Evaluate the efficacy of TRT in reducing the subjective awareness and impact of
           tinnitus.

        -  Determine the therapeutic time course of improvement in tinnitus.

        -  Determine the long-term improvement in tinnitus derived from TRT.
    

Intervention name(s): Tinnitus retraining therapy; Sound therapy
Intervention type(s): Behavioral; Device
Intervention description(s): Sound therapy and counseling; sound therapy and counselling
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: tinnitus
N2003-01: Irinotecan, Temozolomide, and Cefixime in Treating Young Patients With Recurrent or Resistant Neuroblastoma
Condition: Diarrhea; Drug/Agent Toxicity by Tissue/Organ; Neuroblastoma
MeSH terms: Neuroblastoma; Diarrhea; Drug-Related Side Effects and Adverse Reactions
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Drugs used in chemotherapy, such as irinotecan and temozolomide, work in different
      ways to stop tumor cells from dividing so they stop growing or die. Temozolomide may help
      irinotecan kill more tumor cells by making them more sensitive to the drug. Cefixime may be
      effective in preventing diarrhea that is caused by treatment with irinotecan.

      PURPOSE: This phase I trial is studying the side effects and best dose of irinotecan when
      given together with temozolomide and cefixime in treating young patients with recurrent or
      resistant neuroblastoma.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the maximum tolerated dose of oral irinotecan when administered with
           fixed-dose temozolomide and cefixime in pediatric patients with recurrent or resistant
           high-risk neuroblastoma.

        -  Determine the toxic effects of this regimen in these patients.

      Secondary

        -  Determine the response rate in patients treated with this regimen.

        -  Determine the pharmacokinetics of this regimen in these patients.

        -  Correlate UGT1A1 genotype with the occurrence of dose-limiting diarrhea in patients
           treated with this regimen.

        -  Correlate BCRP genotype with pharmacokinetic phenotype in patients treated with this
           regimen.

        -  Correlate p53 status in tumor cells with response in patients treated with this regimen.

      OUTLINE: This is a multicenter, dose-escalation study of irinotecan.

      Patients receive oral cefixime once daily beginning 5 days before the start of fixed-dose
      temozolomide and irinotecan and continuing for the duration of the study. Patients also
      receive oral temozolomide once daily on days 1-5 and oral irinotecan once daily on days 1-5
      and 8-12. Courses repeat every 21 days in the absence of disease progression or unacceptable
      toxicity.

      Cohorts of 3-6 patients receive escalating doses of irinotecan until the maximum tolerated
      dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2
      of 6 patients experience dose-limiting toxicity. A maximum of 12 patients are treated at the
      MTD.

      Patients are followed for toxicity, response, and survival.

      PROJECTED ACCRUAL: A total of 15-30 patients will be accrued for this study within 1.25
      years.
    

Intervention name(s): cefixime; irinotecan hydrochloride; temozolomide
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Cefixime; Irinotecan; Temozolomide
Primary purpose: Treatment
Keywords: diarrhea; drug/agent toxicity by tissue/organ; disseminated neuroblastoma; recurrent neuroblastoma
A Novel Mobile Phone Application ( OptiBP) for Blood Pressure Monitoring
Condition: Technology
Study type: Observational

Summary: 
      Evaluation of a novel mobile application designed to estimate blood pressure
      (systolic-diastolic and mean arterial pressure) based on collected optical signals on
      patient's finger treated in surgical patients in the post-anesthesia care unit
    

Detailed description: 
      The purpose of the study is to compare the blood pressure values measured by a novel mobile
      phone application ( camera of the smartphone will be obstructed by the patient's right index)
      and the values measured by reference method used (the oscillometric brachial cuff).

      All patients scheduled for noncardiac surgery at Erasme Hospital Brussels, Belgium will be
      recruited and their pressure will be measured with both mesurement methods. (novel smartphone
      application versus upper arm cuff oscillometry) at 5 time points (each 20-30 minutes)

      The OptiBP Application is a mobile application installed on a mobile phone which is a
      non-invasive data-logger intended to acquire physiological data from patients. By applying
      the patient's finger on a smartphone's camera, a movie is generated and transformed into
      values of diastolic, mean and systolic blood pressure.

      Three measures will be taken (spaced by one minute) with both methods after a period of 3
      minutes of rest at each time point.

      The patient's blood pressure will be measured in parallel with the mobile application and
      with the reference equipment (the oscillometric brachial cuff).

      Then, the values obtained by the two methods will be compared to confirm the reliability of
      the data obtained with the novel mobile application.

      The goal is therefore to compare blood pressure values as obtained by the analysis of the
      data recorded by the OptiBP Mobile Application, against simultaneous measurements provided by
      the oscillometric brachial cuff
    

Intervention name(s): novel mobile phone application for blood pressure monitoring.
Intervention type(s): Device
Intervention description(s): Comparative blood pressure measurement with the mobile phone application and the non-invasive reference method (upper arm cuff).
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients admitted to the surgical department at Erasme hospital for a moderate risk surgery
Two-month Regimens Using Novel Combinations to Augment Treatment Effectiveness for Drug-sensitive Tuberculosis
Condition: Tuberculosis, Pulmonary
MeSH terms: Tuberculosis; Tuberculosis, Pulmonary
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The current standard management strategy for drug-sensitive pulmonary tuberculosis (TB) is to
      treat with multiple drugs for 6 months, although patients often fail to adhere to the long
      treatment, leading to poor clinical outcomes including drug resistance, which is expensive
      and difficult to treat.

      The TRUNCATE-TB trial evaluates an alternative strategy (the TRUNCATE-TB Management Strategy)
      comprising treatment for 2 months (8 weeks, extended to 12 weeks if inadequate clinical
      response) with a regimen predicted to have enhanced sterilising activity ("boosted regimen")
      and monitoring closely after treatment cessation. Those who relapse (predicted to be always
      drug sensitive and likely to occur early) will be retreated with a standard 6 month regimen.

      The trial is a randomized, open-label, multi-arm, multi-stage (MAMS) trial to test the
      hypothesis that the TRUNCATE-TB Management Strategy is non-inferior to the standard
      management strategy in terms of longer-term outcomes (clinical status at 96 weeks). If
      non-inferiority is demonstrated then the advantages/disadvantages of implementing the
      strategy will be explored in secondary outcomes (from patient and programme perspective).

      The trial will evaluate the TRUNCATE-TB Management Strategy with 4 potential boosted regimens
      (180 per arm, total 900 with the standard TB management strategy arm). The boosted regimens
      include new drugs (licensed drugs, repurposed from other indications) and optimized doses of
      standard drugs, selected based on consideration of maximal sterilising effect, absence of
      drug-drug interactions, as well as safety and tolerability over a period of 2 months
    


Intervention name(s): Rifampicin; Isoniazid; Pyrazinamide; Ethambutol; Linezolid; Clofazimine; Rifapentine; Levofloxacin; Bedaquiline; Rifampicin
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 10mg/kg; 5mg/kg; 25mg/kg; 15mg/kg; 600mg; 200mg; 1200mg; 1000mg; 400mg once daily for 2 weeks then 200mg 3x a week; 35mg/kg
Intervention MeSH terms: Levofloxacin; Rifampin; Isoniazid; Linezolid; Pyrazinamide; Ethambutol; Rifapentine; Bedaquiline; Clofazimine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This study uses a multi-arm, multi-stage (MAMS) parallel study design
Masking: None (Open Label)
Primary purpose: Treatment
Vasopressin to Prevent Hypotension During Beach Chair Surgery
Condition: Rotator Cuff Tear Arthropathy
MeSH terms: Rotator Cuff Tear Arthropathy; Hypotension; Rotator Cuff Injuries
Study type: Observational

Summary: 
      Patients undergoing surgery in beach chair position (BCP) are at risk for cerebral ischaemia.
      The impacts of arginine vasopressin (AVP) on haemodynamics and cerebral oxygenation are
      evaluated during surgery in BCP.
    

Detailed description: 
      Patients undergoing shoulder surgery in BCP under general anaesthesia are randomly allocated
      to receive i.v. normal saline (control group) or AVP 0.05 or 0.07 U kg-1 (AVP group, n = 15
      each) 2 min before moving into BCP. Mean arterial pressure (MAP), heart rate (HR), jugular
      venous bulb oxygen saturation (SjvO2) and regional cerebral tissue oxygen saturation (SctO2)
      are measured before (pre-sitting in supine position) and after patients assumed BCP.
    

Intervention name(s): Vasopressins; Placebo; propofol; sevoflurane
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Vasopressins propofol vasopressins sevoflurane; Placebo propofol & placebo sevoflurane; vasopressin propofol & placebo propofol; vasopressins sevoflurane placebo sevoflurane
Other intervention name(s): Arginine vasopressin; saline 10 ml as placebo; Intravenous anesthetic; general anesthetic
Intervention MeSH terms: Vasopressins; Arginine Vasopressin; Propofol; Anesthetics, Intravenous; Anesthetics; Sevoflurane; Anesthetics, General
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients undergoing shoulder surgery in the beach chair position under the general
        anesthesia
      
Keywords: cerebral oxygen saturation; beach chair position; hemodynamic; jugular venous oximetry