bioihbjkbjnl/mcl2 huggingface dataset:
Clinical Sensitivity of Clearview Rapid Tests in 12-17 y/o Pediatric Population
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Observational

Summary: 
      This study is to establish the clinical sensitivity of the Chembio Diagnostics Systems, Inc.
      Clearview COMPLETE HIV 1/2 Assay and Clearview HIV 1/2 Stat-Pak Assay (Clearview HIV tests)
      in pediatric subjects who are between 12 and 17 years of age. A minimum of ten (10) known
      HIV-positive participants will be tested.
    

Detailed description: 
      In order to achieve the primary objective, clinical trials will be conducted to establish and
      confirm the sensitivity of the Clearview HIV 1/2 tests in the described pediatric population.
      Only HIV-1 will be included in the study.

      The Clearview HIV tests can be used as a safe and effective screening method to aid in the
      diagnosis of infection with HIV 1/2 in the pediatric population aged between 12 and 17 years.

      The secondary objectives of this study include demonstrating that:

      - The Clearview HIV tests detect HIV-1 antibodies in a variety of sample matrices: capillary
      (fingertip) whole blood, venous whole blood, plasma and serum.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The patient population intended for this study (study participants) consists of a minimum
        of 10 individuals, known to have previously tested positive for HIV antibodies, who are
        between 12 and 17 years of age. The patients should not be on HAART, however, the sponsor
        reserves the option to include a limited number of HAART patients for investigational
        purposes. The number of HAART patients enrolled will depend on the available pediatric HIV
        positive participant pool. HAART patients will be clearly identified and will be additional
        to the enrollment needed to meet the study objectives.
      
Biospecimen description: 
      Whole blood, plasma and serum
    
Keywords: HIV-1 Infections
Workers' Acceptability of a Prototype Integrated and Interactive Pedal Desk
Condition: Acceptability of Semi-recumbent Pedal Desk
Study type: Interventional

Summary: 
      The purpose of this study is to assess full-time workers'impressions and acceptability of a
      prototype pedal desk. The pedal-desk is a semi-recumbent (upright) portable pedal mechanism
      that allows workers to complete tasks in a traditional seated position.
    

Detailed description: 
      Researchers in recent years have begun to consider how modern occupational practices and
      environments could be enriched to facilitate increased energy expenditure by replacing
      sedentary behaviors with opportunities for non-exercise physical activity without competing
      with time committed to work tasks. The investigators have developed a pedal desk: a
      semi-recumbent (upright) portable pedal mechanism with a maneuverable and adaptable desktop.
      While utilizing the pedal desk, workers are able to complete their tasks in a more
      traditional seated position. Determining workers' acceptability is a key initial step in
      translating this "sedentary behavior countermeasure" to real workplace settings.

      In addition to having their height, weight, body fat percentage, and bioelectrical impedance
      measured, eligible participants will be asked to complete three tasks while simultaneously
      pedaling at a sustainable and self-selected pace. The three tasks are: 1) compose and send an
      email; 2) search a topic on the internet, and 3) complete an on-line questionnaire. The
      questionnaire that participants will complete was developed specifically for this study,
      utilizes Likert scales, and is based on the Theory of Planned Behavior. Constructs tested
      focus on perceptions of using the pedal desk at work and include: behavioral beliefs,
      normative beliefs, control beliefs, intention, self-efficacy, and an open-ended question
      soliciting general impressions concerning using the pedal desk at work.
    

Intervention name(s): WAPD
Intervention type(s): Device
Intervention description(s): The objective was to assess workers' acceptability of the Pennington Pedal Desk.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Device Feasibility
14-Day Cumulative Irritation Patch Test in Subjects With Normal Skin - Chameleon
Condition: Dermal Irritation
Study type: Interventional

Summary: 
      to determine the ability of the test article to cause irritation to the skin of humans under
      controlled patch test conditions
    


Intervention name(s): Trojan "Chameleon" Personal Lubricant
Intervention type(s): Device
Intervention description(s): silicone base with sensate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
Autonomic Nervous System Activity and Oculocardiac Reflex.
Condition: Bradycardia During Pulling of Eyeball
MeSH terms: Bradycardia
Study type: Observational

Summary: 
      Pulling the eyeball during ophthalmic surgery provokes decrease in heart rate. This
      phenomenon is called oculocardiac reflex. In some patients asystole may occur. Other cardiac
      features of this reflex include hypotension, dysrhythmias, atrioventricular block. These
      cardiovascular disturbances may lead to decreased perfusion and ischemia of vital organs.
      Patients with existing cardiovascular disease are in risk of complications. Cardiovascular
      system is mainly innervated with autonomic nervous system (ANS). Sympathetic/parasympathetic
      activity may be determined by Heart Rate Variability (HRV). HRV analysis based on short 5
      minutes electrocardiography has been found useful for prediction of hypotension and
      bradycardia during induction of general anaesthesia and during spinal block. The aim of this
      study is to verify whether it is possible to predict oculocardiac reflex with the use of HRV
      analysis for ANS activity assessment, measured prior to the ophthalmic surgery.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        patients operated bacause of retinal pathology
      
Keywords: oculocardiac effect; bradycardia; HRV
Effect of Multiple BI 1356 Doses of on the Multiple-dose Pharmacokinetics of a Combination of Ethinylestradiol and Levonorgestrel in Healthy Female Premenopausal Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective was to investigate the effect of multiple oral doses of 5 mg BI 1356 on the
      steady-state pharmacokinetics of ethinylestradiol (EE) and levonorgestrel (LNG), the
      components of Microgynon®
    


Intervention name(s): Microgynon®; BI 1356
Intervention type(s): Drug; Drug
Intervention MeSH terms: Linagliptin; Ethinyl estradiol, levonorgestrel drug combination; Ethinyl Estradiol-Norgestrel Combination
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Long Term and Permanent Contraceptive
Condition: Contraceptive Behavior
Study type: Observational

Summary: 
      We will study with the different variables that affect the intention to use long- acting and
      permanent contraceptive methods among married women in Jordan through a cross sectional
      study. Self- administered questionnaire will be distributed to aid in data collection.
    

Detailed description: 
      In this cross-sectional study, self-administered pre-made questionnaires.
      (https://docs.google.com/forms/d/e/1FAIpQLSdjuuQynIxu0AAmIbKHg0-iyZgTW0m5847JaX0OZrnl7v7v1w/v
      iewform ) will be distributed to married women. (Women of childbearing age). The candidates
      will be selected according to their age (15-49), marital status (married), and pregnancy
      status (non-pregnant). The data collected through the questionnaires will then be processed
      and interpreted in order to understand the variables that affect the use of LACM and
      permanent contraception methods among Jordanian women.
    

Intervention name(s): Al-Husban University Naser
Intervention type(s): Other
Intervention description(s): filling a questionnaire
Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        women aged 15-49 years of age
Pilot Study of Efficacy of Mechanical Insufflation Exsufflation in Stroke
Condition: Stroke; Dysphagia
MeSH terms: Deglutition Disorders; Stroke
Study type: Interventional

Summary: 
      Stroke patients with dysphagia have restrictive lung dysfunction and impaired cough response.
      This pilot study was performed to determine if Mechanical Insufflation Exsufflation (MIE)
      therapy can help recover impaired cough function.
    

Detailed description: 
      Mechanical Insufflation- Exsufflation (MI-E) is an assisted coughing machine that has been
      proven to be very effective in preventing the deterioration of pulmonary function in patients
      with degenerative neuromuscular disorders. Impaired airway clearance in stroke patients is
      associated with increased incidence of aspiration pneumonia.

      In this pilot study the investigators attempt to assess the efficacy of MI-E as part of a
      protocol for patients with dysphagia with impaired cough response.
    

Intervention name(s): Mechanical Insufflation Exsufflation
Intervention type(s): Device
Intervention description(s): Mechanical Insufflation Exsufflation -Each patient received daily treatments by means of a light-weight, elastic oronasal mask. Treatments were divided between morning and afternoon and were carried out 5 times a week. A total of 20 sessions were carried out by a a trained respiratory therapist.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stroke, dysphagia, cough, mechanical insufflation exsufflation
Uroxatral in Men With Benign Prostate Hypertrophy (BPH) and Erectile Dysfunction (ED)
Condition: BPH; Erectile Dysfunction
MeSH terms: Erectile Dysfunction; Prostatic Hyperplasia; Hypertrophy
Study type: Interventional

Summary: 
      Uroxatral (alfuzosin) may not only help BPH symptoms but may also improve sexual function in
      males with BPH and ED.
    

Detailed description: 
      The study will consist of a 30 day screening/washout phase at the end of which qualified
      subjects will be assigned to alfuzosin 10 mg tablets once a day. Subjects will be treated for
      90 days. The total duration of the study will be 120 days.
    

Intervention name(s): Alfuzosin 10 mg
Intervention type(s): Drug
Intervention MeSH terms: Alfuzosin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effect of Mobile Health Application Based on Omaha System on Symptoms and Quality of Life in COVID-19 Patients
Condition: COVID-19; Symptoms and Signs; Quality of Life
MeSH terms: COVID-19
Study type: Interventional

Summary: 
      Purpose: The aim of this study is to evaluate the effects of nursing interventions made with
      a mobile health application (COVOS) developed based on the Omaha System on the physical,
      psychosocial and cognitive symptoms and quality of life of patients diagnosed with COVID-19,
      and continuing treatment at home.

      Design: This is a single center, 1:1 randomized, single blind, parallel, active comparator
      trial.

      Method: Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) Statement
      2013 checklist used in study. The CONSORT (Consolidated Standards of Reporting Trials)
      flowchart is used in this protocol. This study will carried out in a family health center,
      located within the boundaries of İzmit District of Kocaeli province. The patients in the
      experimental group will be followed up with the COVOS app and nursing interventions (videos,
      information messages) to manage their symptoms will be directed with the COVOS app. The
      patients in the control group will not receive any intervention, the standard follow-up and
      health care provided by the family health center of the patients will continue.

      Hypothesis: In patients diagnosed with COVID-19 followed at home with COVOS, symptom
      management and quality of life will be better in 1st, 2nd and 3rd months compared to the
      control group.
    


Intervention name(s): COVOS app; Standard Care
Intervention type(s): Other; Other
Intervention description(s): In this study, the patients in the experimental group will be followed up with the COVOS app and nursing interventions (videos, information messages) to manage their symptoms will be directed with the COVOS app.; In this study, the patients in the control group will not receive any intervention, the standard follow-up and health care provided by the family health center of the patients will continue.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Omaha System; Mobile health app
Heart And Lung Failure - Pediatric INsulin Titration Trial
Condition: Heart Failure; Respiratory Failure
MeSH terms: Respiratory Insufficiency
Study type: Interventional
Phase: Phase 3

Summary: 
      Stress hyperglycemia, a state of abnormal metabolism with supra-normal blood glucose levels,
      is often seen in critically ill patients. Tight glycemic control (TGC) was originally shown
      to reduce morbidity and mortality in a landmark randomized clinical trial (RCT) of adult
      critically ill surgical patients but has since come under intense scrutiny due to conflicting
      results in recent adult trials. One pediatric RCT has been published to date that
      demonstrated survival benefit but was complicated by an unacceptably high rate of severe
      hypoglycemia. The Heart And Lung Failure - Pediatric INsulin Titration (HALF-PINT) trial is a
      multi-center, randomized clinical treatment trial comparing two ranges of glucose control in
      hyperglycemic critically ill children with heart and/or lung failure. Both target ranges of
      glucose control fall within the range of "usual care" for critically ill children managed in
      pediatric intensive care units.

      The purpose of the study is to determine the comparative effectiveness of tight glycemic
      control to a target range of 80-110 mg/dL (TGC-1, 4.4-6.1 mmol/L) vs. a target range of
      150-180 mg/dL (TGC-2, 8.3-10.0 mmol/L) on hospital mortality and intensive care unit (ICU)
      length of stay (LOS) in hyperglycemic critically ill children with cardiovascular and/or
      respiratory failure. This will be accomplished using an explicit insulin titration algorithm
      and continuous glucose monitoring to safely achieve these glucose targets. Both groups will
      receive identical standardized intravenous glucose at an age-appropriate rate in order to
      provide basal calories and mitigate hypoglycemia. Insulin infusions will be titrated with an
      explicit algorithm combined with continuous glucose monitoring using a protocol that has been
      safely implemented in 490 critically ill infants and children.
    


Intervention name(s): Insulin; Insulin
Intervention type(s): Drug; Drug
Intervention description(s): IV insulin titration to target a blood glucose of 80-110 mg/dL; IV insulin titration to target a blood glucose of 150-180 mg/dL
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cardiovascular; Respiratory; Failure; Heart; Lung; Continuous glucose monitoring; Tight glycemic control; Subcutaneous; Insulin; Algorithm
HIV Point-of-Care Test Evaluation in Infants
Condition: HIV
Study type: Interventional

Summary: 
      HIV Point-of-Care tests in Babies Study (BABY) - Operational evaluation of HIV Point-of-Care
      tests for very early infant HIV diagnostics in infants born to HIV infected mothers in Mbeya,
      Tanzania.
    

Detailed description: 
      This in-vitro diagnostic (IVD) study in infants born to HIV infected mothers evaluates the
      reliability and operational feasibility of an HIV Point-of-Care (PoC) test for HIV early
      infant diagnosis (EID) in a public health setting at obstetric clinics in Mbeya, Tanzania.

      Recruitment is planned to take place at 4 obstetric/maternity study sites in and around Mbeya
      over a time period of 12 months. The HIV PoC test will be validated against the
      Standard-of-Care diagnostic test, i.e. Dried Blood Spot (DBS) analyses.

      The PoC test under investigation is the Xpert HIV-1 Qual produced by Cepheid, Sunnyvale, USA.
    

Intervention name(s): In-vitro Diagnostics
Intervention type(s): Other
Intervention description(s): Ex-vivo performed diagnostic blood based test.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: In-vitro Diagnostics; paediatrics
Treatment of Peripheral T-cell Lymphoma
Condition: Peripheral T-cell Lymphoma
MeSH terms: Lymphoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of GDPT regiment
      (gemcitabine，cisplatin,Prednisone ,Thalidomide

      ) for patients with Peripheral T-cell lymphoma.
    

Detailed description: 
      Patients with Peripheral T-cell lymphoma usually have a bad prognosis. These patients cannot
      be treated successfully with the conventional chemotherapy of CHOP. The investigators have
      been proceeding this trial to evaluate the efficacy and safety of the combination
      chemotherapy regiment GDPT regiment (gemcitabine，cisplatin,Prednisone ,Thalidomide

      ) in the patients with Peripheral T-cell lymphoma.
    

Intervention name(s): GDPT regimen; CHOP regimen
Intervention type(s): Drug; Drug
Intervention description(s): GDPT regimen(Gemcitabine,Cisplatin,Prednisone ,Thalidomide) Cisplatin(DDP) 25 mg/m2,ivgtt（intravenously guttae）,d1-3;Prednisone 60mg/m2,p.o,d1-5;Gemcitabine(GEM) 800mg/m2,ivgtt,30min,d1,8;Thalidomide,p.o,200mg/d,Continued use to the end of chemotherapy .Every 21 days for one cycle and three cycles are required. Efficacy was evaluated every two cycles.; CHOP regimen(Cyclophosphamide,Vincristine,Doxorubicin,Prednisone) Cyclophosphamide 750mg/d,ivgtt, d1;Vincristine,1.4g/m2,ivgtt, d1;Doxorubicin,50mg/m2,ivgtt,d1;Prednisone 60mg/m2,p.o, d1-5.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Peripheral T-cell lymphoma;chemotherapy;; RR;PFS;OS
Is Saxenda® a Viable Treatment of Obese Patients in Forensic Psychiatry?
Condition: Mental Disorder; Metabolic Disturbance; Feasibility; Overweight and Obesity; Liraglutide
MeSH terms: Overweight; Mental Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      An open-label, multi-centre, 26-weeks clinical feasibility study. The objective is to explore
      whether Saxenda could be a feasible choice in the treatment of overweight, obesity and
      weight-related medical problems, in patients diagnosed with a severe mental illness and
      hospitalized at a forensic department in Denmark. We wish to determine the viability of the
      daily Saxenda®-injection treatment in this specific patient group.
    


Intervention name(s): liraglutide 3 mg (Saxenda®) once-daily
Intervention type(s): Drug
Intervention description(s): Liraglutide 3 mg (Saxenda®) 6 mg/ml, 3 ml pre-filled pen-injector. The injection is administered subcutaneously. The initial daily dose will be 0.6 mg liraglutide (Saxenda®) for one week. If tolerated patients increase the dose by +0.6 mg each week until the full maintenance of 3 mg is reached (week 1: 0.6 mg, week 2: 1.2 mg, week 3: 1.8 mg, week 4: 2.4 mg, week 5-26: 3.0 mg. If necessary, a longer titration period is accepted). If the lowest tolerated dose is less than 1.8 mg of liraglutide (Saxenda®) once-daily after 12 weeks from inclusion, the patient will be excluded from the study.
Intervention MeSH terms: Liraglutide
Intervention model: Single Group Assignment
Intervention model description: An open-label, multi-centre, 26-weeks clinical feasibility study
Masking: None (Open Label)
Primary purpose: Treatment
A Trial to Evaluate Safety, Tolerability, and Efficacy of Orally Administered OPC-67683
Condition: Tuberculosis, Multidrug-Resistant
MeSH terms: Tuberculosis; Tuberculosis, Multidrug-Resistant
Study type: Interventional
Phase: Phase 2

Summary: 
      A phase 2, multicenter, uncontrolled, open-label trial in participants with Multi-drug
      Resistant Tuberculosis (MDR-TB). Only participants who completed Trial 242-07-204
      (NCT00685360) were eligible. The trial was performed globally at 14 sites qualified to treat
      MDR-TB. All 434 participants who completed Trial 242-07-204 were eligible for this trial if
      there was still potential clinical benefit to them and all inclusion criteria and no
      exclusion criteria were met.
    


Intervention name(s): Delamanid; OBR
Intervention type(s): Drug; Drug
Intervention description(s): Delamanid was administered orally twice daily as 50-mg tablets under fed conditions in the morning and evening.; Selection and administration of the treatment medications (i.e. OBRs) was based on World Health Organization (WHO's) Guidelines for the programmatic management of drug-resistant TB, in conjunction with national TB program guidelines. Study investigators could change OBR for a participant based on his/her tolerability and drug susceptibility testing (DST) results.
Other intervention name(s): OPC-67683; Deltyba
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Interaction of Apelin and Angiotensin in the Human Forearm Circulation
Condition: Heart Disease; Vasodilation
MeSH terms: Heart Diseases
Study type: Interventional

Summary: 
      The apelin-APJ system is a relatively new discovery. It has generated interest in part due to
      it's apparent ability to counteract the renin-angiotensin system, which is frequently
      overactive in many cardiovascular disease.

      Apelin has the ability to cause blood vessels to relax, increasing their diameter and hence
      blood flow down the blood vessel. The researchers wish to investigate the hypothesis that an
      infusion of apelin will reduce the effects of angiotensin II, which is know to reduce the
      diameter of blood vessels.
    


Intervention name(s): Angiotensin II; Noradrenaline infusion
Intervention type(s): Drug; Drug
Intervention description(s): Infusion of up to 30picmol/ml angiotensin II will be infused and respondent vasoconstriction assessed.; Infusion of up to 480 picomol/ml of noradrenaline will be infused.
Intervention MeSH terms: Norepinephrine; Angiotensin II; Giapreza; Angiotensinogen
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Renin angiotensin system; Apelin; Vasodilatation; Heart disease; Vascular biology