bioihbjkbjnl/mcl2 huggingface dataset:
Favipiravir Plus Hydroxychloroquine and Lopinavir/Ritonavir Plus Hydroxychloroquine in COVID-19
Condition: COVID-19; Favipiravir; Kaletra; Hydroxychloroquine; Lopinavir/Ritonavir
MeSH terms: COVID-19
Study type: Interventional

Summary: 
      This is an open-label, non-randomized clinical trial study. The number of 40 COVID-19
      patients with moderate severity will be admitted in progressive care units (PCUs) and
      intensive care units (ICUs) enrolled in the study. The sampling will be purposive and based
      on the same independent variables, including age, gender, past medical histories, and the
      situation of the patient at the admission day, and ventilator support. The patients will be
      allocated into two groups with different regimens. Group "A" (regimen A)will be defined as
      Favipiravir 1600 mg a first dose and 600 mg in 3 divided doses daily plus 400 mg in 2 divided
      doses of Hydroxychloroquine every day. The group "B" (regimen B) will be contained 400 mg of
      Lopinavir/Ritonavirin 2 divided doses plus the first dose (400 mg) of Hydroxychloroquine.
      Hydroxychloroquine will not be used for adverse drug reactions. The regimen remained at least
      7 up to 10 days.

      Data will be analyzed using statistical package for social sciences (SPSS) version 18 (SPSS
      Inc. Chicago, IL, USA) for windows. The variables will be compared using independent and
      paired T-test for normally distributed variables and Wilcoxon, Chi-square for non-normal
      distributed variables. The Kaplan Meier test will be used for survival analysis and the
      one-sample Kolmogorov-Smirnov test for the evaluation of distributions.
    


Intervention name(s): Favipiravir; Hydroxychloroquine; Lopinavir / Ritonavir
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Patients will be given a stat dose of 1600mg Favipiravir tablets for the first time, and for next time they will be given 600mg of favipiravir tablets three times per day for 7 days; 200mg of Hydroxychloroquine two times per day will be given to patients for seven days in Test group, and Patients in Control group will be given a stat dose of 400mg Hydroxychloroquine tablets two times per day.; Patients will be given 200/50 mg of Lopinavir / Ritonavir two times per day for seven days.
Other intervention name(s): Kaletra
Intervention MeSH terms: Ritonavir; Lopinavir; Hydroxychloroquine; Favipiravir
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Human Papillomavirus in Young People Epidemiological Research 2 (HYPER2)
Condition: Human Papillomavirus; Human Papillomavirus Infection
MeSH terms: Infections; Papillomavirus Infections
Study type: Observational

Summary: 
      Australia was one of the countries to implement a universal school-based male vaccination
      program - in 2013. This research project will examine the prevalence of HPV among young men
      who have sex with men (MSM) who have been offered school-based HPV vaccination.
    

Detailed description: 
      HYPER-2, will be a cross-section study, using the same recruitment and testing strategies
      used in HYPER 1, which determined the prevalence of anal, genital and oral HPV among men who
      have sex with men aged 16-20 years. Given the differing age groups that will have been
      offered vaccination over the 2 study period, men aged 16-19 will be recruited in the first
      year (2017) and men aged 16-20 will be recruited in the second year (2018) to ensure that the
      participants included in the HYPER-2 study would have been eligible for the free male HPV
      vaccine in Australia. A total of 200 men will be recruited over a 2-year period, and HPV
      vaccination status for each participant will be verified against the National HPV Vaccination
      Program Register.

      This 2-year cross-sectional study will recruit men who report sex with men aged from 16 to 20
      years.
    

Observational model: Ecologic or Community
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Young same sex attracted men 16-20 years of age in Melbourne, Australia
      
Biospecimen description: 
      1. Oral sampling for HPV

        2. Anal sampling for HPV&

        3. Penile sampling for HPV

        4. Blood for HPV, HIV, Syphilis

        5. Anal swabs for rectal gonorrhoea and chlamydia

        6. Pharyngeal swabs for gonorrhoea and chlamydia

        7. Urine sample for gonorrhoea and chlamydia

      Oral, penile, and anal specimens will be collected from each man at two visits 7 days apart.
      Routine HIV and STI (chlamydia, gonorrhoea, and syphilis) screening will be performed at
      baseline (Day 0).
Asthmatic Subjects Could Live Without Short Acting beta2 Agonists
Condition: Asthma Chronic
MeSH terms: Asthma
Study type: Observational

Summary: 
      Since 2006 there was a plateau in world wide mortality from asthma. Overreliance in Short
      Acting Beta2 Agonists (SABA) was associated with increased risk of death from asthma. Long
      acting beta agonists (LABA) alone was not permitted as treatment for asthma as it was
      determined by FDA by the "black box". By contrast SABA does not have a "black box", despite
      similar overuse alerts associated with increased risk of death from asthma. the investigators
      want to know if exist asthmatic subjects that do use another rescue medication; not SABA, and
      to compare their features, Asthma Control Test (ACT), and lung function in a outpatient
      facility.

      First consecutive visits at outpatient Pulmonary Section of asthmatic subjects were
      described. Asthma Control Test (ACT) that was routinely used to assess asthma and spirometry
      were performed.
    

Detailed description: 
      During the period from March 10, 2017 to January 16, 2018 the investigators decided to
      describe the rescue medication in all new asthmatic subjects that came for a first visit to
      the outpatient pulmonary department. Patients aged ≥16 years were entered in the study with a
      a diagnosis of asthma, based on a history of episodic dyspnea and wheezing, and/or documented
      bronchodilator reversibility in forced expiratory volume in 1 s (FEV1) of 12% and 200 ml
      according to the National Institutes of Health criteria; to be non- or ex-smoker of less than
      10 pack-yr, to be neither pregnant nor breast-feeding and to be capable of completing Asthma
      control test and spirometry. Consecutive patients visiting the outpatient pulmonary
      department were included in the description.
    

Intervention name(s): NO Intervention
Intervention type(s): Other
Intervention description(s): Routine clinical data; asthma control test and spirometry
Other intervention name(s): Self-administered asthma control test and spirometry.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Outpatients coming for a first visit to the Pulmonary Section, not only due to asthma; but
        also for presurgical assessment and/or Spirometry prescription.
      
Keywords: asthma; SABA
Organ Protection With Sevoflurane Postconditioning After Cardiac Surgery With Cardiopulmonary Bypass
Condition: Cardiac On-pump Surgery
Study type: Interventional

Summary: 
      Organ protection, volatile anesthetics, postconditioning.

      Sedation of patients on ICU after cardiac surgery with cardiopulmonary bypass with either
      propofol or sevoflurane. Evaluation of organ function and inflammatory mediators in the
      blood.
    


Intervention name(s): Sevoflurane; Propofol
Intervention type(s): Drug; Drug
Intervention description(s): Sedation with sevoflurane; Sedation on intensive care unit with propofol
Intervention MeSH terms: Propofol; Sevoflurane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
eMOMS of Rochester
Condition: Gestational Weight Gain; Postpartum Weight Retention
MeSH terms: Body Weight; Weight Gain; Gestational Weight Gain
Study type: Interventional
Phase: Phase 3

Summary: 
      The project aims to develop, implement and evaluate electronically-mediated behavioral
      intervention programs for pregnant and postpartum women in order to prevent excessive weight
      gain during pregnancy and postpartum weight retention.
    

Detailed description: 
      This study seeks to expand the understanding of how to slow the accumulation of weight in
      childbearing women. The intervention goals are to decrease the prevalence of excessive
      pregnancy weight gain and mean weight retention in the first 18 months postpartum in
      socio-economically and racially/ethnically diverse sample of 1,641 pregnant women. Women will
      be randomly assigned to one of three groups: Intervention Group 1 will receive the
      intervention program only during pregnancy (e-intervention 1). Intervention Group 2 will
      receive e-intervention 1 plus intervention for 18 months postpartum (e-intervention 2).
      Control women will receive non-weight related content during both time periods at the project
      website. The primary hypotheses for the randomized controlled trial are: H1: The proportion
      of women in Intervention Groups 1 and 2 who gain more weight in pregnancy than is recommended
      by the IOM will be 33% less than the proportion of the women in the Control Group who gain
      excessively and H2: The Control Group will have a higher mean weight retention at 12 months
      postpartum than Intervention Groups 1 and 2.
    

Intervention name(s): electronic intervention during pregnancy and postpartum; electronic intervention during pregnancy; Control
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Electronically-mediated behavioral interventions to encourage women to gain an appropriate amount of weight during pregnancy and to follow a healthy lifestyle postpartum to minimize postpartum weight retention; Electronically-mediated behavioral interventions to encourage women to gain an appropriate amount of weight during pregnancy.; Control women will receive non-weight related content during both time periods at the project website.
Other intervention name(s): Behavior modification intervention for pregnancy; Behavior modification intervention for postpartum; Prevention of excessive gestational weight gain; Prevention of postpartum weight retention; Electronically-mediated behavioral interventions; Behavior modification intervention for pregnancy; Prevention of excessive gestational weight gain; Electronically-mediated behavioral interventions; Control group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Pregnancy; Postpartum; Weight gain; Weight retention; Behavior; Electronic Media; Randomized Clinical Trial
Stem Cell Study for Patients With Leg Ulcer/Gangrene
Condition: Leg Pain; Ulcer; Gangrene; Ischemia; Peripheral Vascular Diseases
MeSH terms: Vascular Diseases; Peripheral Vascular Diseases; Peripheral Arterial Disease; Ulcer; Ischemia; Gangrene
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to determine if stem cell therapy with one's own cells
      (autologous cells) delivered intramuscularly to one's leg with ulcer and/or gangrene due to
      poor blood flow will be safe and if it will relieve leg pain, increase blood flow, and/or
      cure the leg wound.
    

Detailed description: 
      Chronic critical limb ischemia (CLI) is a progressive disease, which arises as a result of
      atherosclerosis or vasculitis in leg arteries. Prognosis of chronic CLI is poor, and no
      effective treatments have been established in patients who are not eligible for the
      traditional revascularization therapies such as angioplasty and bypass procedures due to the
      inappropriate anatomy of the leg arteries or frequent reocclusion following
      revascularization. Therefore, it is necessary to establish novel revascularization treatment
      to improve prognosis of the no-option patients. We will study the safety and clinical
      efficiency of vascular regeneration by means of transplantation of autologous peripheral
      blood endothelial progenitor cells (CD34 positive cells) in patients with chronic CLI who are
      not eligible for traditional revascularization treatments. The primary endpoint is the
      primary efficacy score identified by toe brachial blood pressure index (TBPI), absolute
      claudication distance (ACD) and Wong Baker's pain rating scale, while the secondary endpoints
      are evaluation of safety, ankle brachial blood pressure index (ABPI), percutaneous tissue
      oxygen pressure (TcPO2), etc.
    

Intervention name(s): Autologous peripheral blood CD34 positive cell therapy
Intervention type(s): Genetic
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Ulcer/ gangrene; Leg diseases; Pain; Vascular diseases; Chronic limb ischemia; Peripheral artery disease
Comparison Between Dexmedetomidine and Propofol for Patients in the Intensive Care Unit After Abdominal Surgery
Condition: Microcirculation
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a single-blind randomized clinical trial. Patients undergoing abdominal surgery will
      be enrolled and randomly divided into two groups: dexmedetomidine group and propofol group.
      In the dexmedetomidine group, patients will receive continuous intravenous infusion of
      dexmedetomidine (infusion dosage range: 0.1 ~ 0.7 mcg/kg/h). In the propofol group, patients
      will receive continuous intravenous infusion of propofol (infusion dosage range: 0.3 ~ 1.6
      mg/kg/h). Hemodynamics will be continuously monitored using a non-invasive monitoring with
      chest bioreactance technique at preset time points (0, 2, 4, 6, 12h and 24h). Clinical data
      such as vital signs, hemodynamic parameters, laboratory results and fluid balance will be
      recorded. The microcirculation will be examined by Cytocam. The following microcirculatory
      parameters will be investigated: total small vessel density, perfused small vessel density,
      microvascular flow index, and heterogeneity index. The enzyme-linked immunosorbent assays
      will be used to measure serum level of endocan, diamine oxidase, and neutrophil
      gelatinase-associated lipocalin at preset time points. The primary goal of this study is to
      compare the effect on microcirculation between dexmedetomidine and propofol in intensive care
      unit patients after abdominal surgery.
    


Intervention name(s): Dexmedetomidine; Propofol
Intervention type(s): Drug; Drug
Intervention description(s): Patient receives continuous intravenous infusion of dexmedetomidine (infusion dosage range: 0.1 ~ 0.7 mcg/kg/h); Patient receives continuous intravenous infusion of propofol (infusion dosage range: 0.3 ~ 1.6 mg/kg/h)
Other intervention name(s): Precedex; Fresofol
Intervention MeSH terms: Dexmedetomidine; Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Prospective Investigation of Pulmonary Embolism Diagnosis (PIOPED II)
Condition: Lung Diseases; Pulmonary Embolism; Venous Thromboembolism
MeSH terms: Lung Diseases; Pulmonary Embolism; Embolism; Thromboembolism; Venous Thromboembolism
Study type: Interventional

Summary: 
      To determine the value of contrast enhanced spiral computed tomography (spiral CT) for the
      diagnosis of acute pulmonary embolism (PE).
    

Detailed description: 
      BACKGROUND:

      Approximately 600,000 Americans sustain pulmonary embolism each year; one-third of these
      episodes are fatal. Unfortunately, pulmonary embolism is underdiagnosed and, therefore,
      under-treated. A substantial body of evidence suggests that the diagnosis of pulmonary
      embolism is not made in the majority of patients in whom it causes or contributes to death.

      In the main, there are two explanations for the failure to diagnose pulmonary embolism:
      pulmonary embolism may be clinically silent, and there is no definitive, noninvasive
      diagnostic test. Indeed, ventilation perfusion lung scans are nondiagnostic in the majority
      of patients with suspected acute pulmonary embolism. Pulmonary angiography may be used to
      establish a diagnosis in such patients, but it is underutilized because of a mortality risk
      around 1 percent.

      Recently, relatively small studies have suggested that contrast enhanced spiral computed
      tomography (CT) scanning is a useful diagnostic test for pulmonary embolism, with sensitivity
      as high as 80 percent and specificity as high as 95 percent. Spiral CT is widely available
      and much less invasive than pulmonary angiography. If spiral CT could be established as a
      useful diagnostic test, pulmonary embolism would be diagnosed more effectively and more
      patients would receive proper treatment.

      DESIGN NARRATIVE:

      The study evaluates the role of spiral CT scan in the diagnosis of PE by comparison with a
      composite reference test, including pulmonary angiography, V/Q lung scan in patients without
      prior PE and compression ultrasound of the lower extremities in patients with no prior deep
      venous thrombosis (DVT).
    

Intervention name(s): Tomography, X-ray Computed
Intervention type(s): Device
Primary purpose: Diagnostic
Associations Analysis Between Lifestyle and Osteoporosis
Condition: Osteoporosis of Disuse With Current Pathological Fracture
MeSH terms: Osteoporosis; Fractures, Spontaneous
Study type: Observational

Summary: 
      A large-scale, community-based, cross-sectional study was conducted to evaluate the extent to
      which lifestyle was associated with osteoporosis among the Chinese population by using
      self-reported questionnaire methods.
    

Detailed description: 
      A large-scale, community-based, cross-sectional study was conducted to evaluate the extent to
      which lifestyle was associated with osteoporosis among the Chinese population by using
      self-reported questionnaire methods. More than 3000 participants were recruited in
      communities in Shanghai. Data involved in demographic information, lifestyle, dietary habits,
      medical history and clinical biomarkers were collected. Every participants were measured bone
      mineral density (BMD g/cm2) at calcaneus by standardized quantitative ultrasound (QUS,
      Hologic Inc., Bedford, MA, USA) utilizing T-scores based on WHO criteria. A standard
      statistical analysis including univariate and multiple variables regression analysis to
      explore the risk or preventive factors involved in Chinese lifestyle associated with
      osteoporosis.
    

Observational model: Ecologic or Community
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        We performed a risk-factor study for osteoporosis using a random sample of the Chinese
        population. Participants were recruited from rural and urban communities in Shanghai.
        Survey participants aged 30-90 years were included in this study.
A Single-dose, Dose-escalation Study of a Long-acting MOD-6031 in Healthy Overweight or Obese Subjects
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional
Phase: Phase 1

Summary: 
      MOD-6031 is a long-acting reversibly PEGylated oxyntomodulin (OXM) therapeutic. The active
      moiety is a gastrointestinal neuropeptide with a sequence identical to endogenous human OXM
      and is an agonist for both glucagon-like peptide-1 (GLP1) and glucagon (GCG) receptors. The
      peptide is a natural appetite suppressant, secreted by L-cells in the digestive system
      following food intake leading to a decrease in gastric emptying, satiety after crossing the
      blood-brain barrier, and regulation of insulin and glucose levels. Thus, MOD-6031 is being
      developed as a treatment for high risk subjects (obese) to increase weight loss, reduce food
      intake and increase glycemic control.
    

Detailed description: 
      This will be a a randomized, single-blind, placebo-controlled, single-dose, dose-escalation
      study. Five escalating dose groups are planned, with 8 subjects per dose group, randomized in
      3:1 ratio to receive a single dose of MOD-6031 or matching Placebo (6 MOD-6031 to 2 placebo
      subjects). The initial MOD-6031 dose will be 20 mg, followed by single doses of 50 mg, 100
      mg, 150 mg and 200 mg. Each subject will receive a single study drug injection in the morning
      (dosing day designated as Day 0) and will be monitored for 30 days.
    

Intervention name(s): MOD-6031; Placebo control
Intervention type(s): Drug; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Obesity
Ferric Citrate for the Treatment of Hyperphosphatemia in Patients With Chronic Kidney Disease Undergoing Hemodialysis
Condition: Hyperphosphatemia; End Stage Renal Disease; ESRD
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Kidney Failure, Chronic; Hyperphosphatemia
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate the efficacy and safety of ferric citrate capsules for the treatment of
      hyperphosphatemia in patients with chronic kidney disease undergoing hemodialysis
    

Detailed description: 
      This is a multicenter, randomized, open-label, active-controlled, parallel, phase III study
      which aims to assess the efficacy and safety of ferric citrate capsules for the treatment of
      hyperphosphatemia in patients with chronic kidney disease undergoing hemodialysis. This study
      is consisting of a Screening/Washout period (14 days) and a Treatment/Observation period (12
      weeks). During the Treatment period, the subjects will be randomly assigned to the ferric
      citrate capsule group (study group) or sevelamer carbonate tablet group (control group) in
      the ratio of 1:1.
    

Intervention name(s): Ferric Citrate; Sevelamer Carbonate
Intervention type(s): Drug; Drug
Intervention description(s): Take the capsules with meals or immediately after meals.; Take the tablets with meals.
Intervention MeSH terms: Sevelamer
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Kidney Diseases; Kidney Failure, Chronic; Hyperphosphatemia; Renal Insufficiency, Chronic; Renal Insufficiency; Phosphorus Metabolism Disorder