bioihbjkbjnl/mcl2 huggingface dataset:
External Validation of the 4C Mortality Score for Hospitalised Patients With COVID-19 in a Tunisian Cohort
Condition: COVID-19 Pandemic
MeSH terms: COVID-19
Study type: Observational

Summary: 
      Risk prediction scores are important tools to support clinical decision-making for patients
      with coronavirus disease (COVID-19). The objective of this paper was to validate the 4C
      mortality score, originally developed in the United Kingdom, for a tunisian population, and
      to examine its performance over time.
    

Detailed description: 
      Coronavirus disease (COVID-19) caused by the Severe Acute Respiratory Syndrome Virus 2
      (SARS-CoV-2) can progress to acute respiratory distress syndrome, multiorgan failure, and
      death in some cases. The clinical presentation and progression of COVID-19 in patients is
      highly variable, which makes it difficult for clinicians to triage patients and determine
      their prognostic risk. A simple, validated prognostic tool using data that is available at
      presentation can help clinicians better prognosticate and support clinical decision-making .
      Numerous tools to predict mortality in COVID-19 patients have been developed, but many are
      limited due to small derivation cohort sizes and/or inadequate validation.

      The 4C mortality score is an accessible risk stratification score developed by the
      International Severe Acute Respiratory and Emerging Infections Consortium (ISARIC). It was
      derived and internally validated on a large, diverse cohort within the United Kingdom but
      requires external validity to confirm its generalizability.

      The objective of this study was to validate the 4 C Mortality risk score to predict
      in-hospital mortality among adults hospitalised with COVID-19 in a Tunisian cohort.

      .
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Patients included in this study had a positive SARS-CoV-2 PCR test result and were admitted
        through the emergency department one of the participating centers, between november
        1st,2020 to December 1st, 2021.
      
Keywords: covid-19; SARS-COV2; 4c score; validation
Comparison Between 6 Minute Walk Test, 6 Minute Step Test and 4 Metre Gait Speed
Condition: Healthy; Children
Study type: Interventional

Summary: 
      The purpose of this study is to find an alternative to the six minute walk test by validating
      six minute step test and four metre gait speed in healthy children. Both tests were
      previously validated in adults and are easier to achieve in non-hospital settings.
    


Intervention name(s): 6 minutes walking test; 6 minutes step test; 4 meters gait speed
Intervention type(s): Other; Other; Other
Other intervention name(s): walk during 6 minutes as fast as possible; up and down a step during 6 minutes as fast as possible; walk a four metre distance
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: evaluation; exercise tolerance; healthy children; 6MWT
GlObal Secondary Prevention strategiEs to Limit Event Recurrence After Myocardial Infarction. GOSPEL Study
Condition: Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction; Recurrence
Study type: Interventional

Summary: 
      Cardiac rehabilitation programmes are a proven treatment for individuals with recent
      myocardial infarction, resulting in reduced morbidity and mortality compared to usual care.
      Unfortunately, following completion of a cardiac rehabilitation programme, risk factors and
      lifestyle behaviours may deteriorate. The GOSPEL study investigates the benefits of a
      programme of continued educational and behavioural intervention to achieve optimal long-term
      secondary prevention goals.
    

Detailed description: 
      Study partially sponsored by Società Prodotti Antibiotici
    

Intervention name(s): multifactorial continued educational - behavioural programme
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: cardiac rehabilitation; lifestyle management; risk factor management; myocardial infarction; randomized trials
Food Effect on Pharmacokinetic Parameters of ABX464
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The goal of this study is to determine the impact of the food on the absorption of the
      ABX464.
    

Detailed description: 
      This is a phase I, single-center, open-label, two-treatment, food-effect, randomized study in
      40 healthy Caucasian male subjects in order to determine the impact of the food on the
      absorption of the ABX464.

      The two different treatments are the followings:

        -  Treatment A = 50mg of ABX464 (two 25mg capsules) /Fasted

        -  Treatment B = 50mg of ABX464 (two 25mg capsules) / Fed

      This study consists of two groups:

        -  Group 1 - single dose assessments, two-period, two-treatment, cross-over: 20 subjects
           will receive a single dose of 50mg of ABX464 in fed and fasted condition, separated by a
           wash-out period of at least 45 days.

        -  Group 2 - multiple dose assessments: 20 subjects will receive 50mg of ABX464 every 3
           days during 10 days in fasted or fed condition.
    

Intervention name(s): ABX464 Single dose; ABX464 Repeated dose
Intervention type(s): Drug; Drug
Intervention description(s): Two-periods, subjects received a single dose of 50mg of ABX464 in fed and fasted condition, separated by a wash-out period of at least 45 days.; Subjects received 50mg of ABX464 every 3 days during 10 days in fasted or fed condition.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Clinical Evaluation of the Click Sexual Health Test for the Detection of Neisseria Gonorrhoeae (NG), Trichomonas Vaginalis (TV), and Chlamydia Trachomatis (CT) in Women
Condition: Chlamydial Infection; Gonococcal Infection; Trichomoniasis
MeSH terms: Infections; Communicable Diseases; Chlamydia Infections; Gonorrhea; Trichomonas Infections
Study type: Observational

Summary: 
      This study is a multi-center study with a minimum of three CLIA-waived intended operator
      sites in the United States in which prospectively self-collected vaginal specimens obtained
      from subjects who are symptomatic or asymptomatic for CT, NG, or TV will be evaluated with
      the Click Sexual Health Test in a Clinical Laboratory Improvement Amendments (CLIA) waived
      setting. Subjects interested in participating in this study will be assessed for eligibility
      and asked to give informed consent and assent, if applicable, by the Investigational Review
      Board (IRB). Only those subjects who meet the inclusion and exclusion criteria may be
      enrolled in the study.
    


Intervention name(s): Click Sexual Health Test
Intervention type(s): Diagnostic Test
Intervention description(s): The Click Device is a single-use (disposable), fully integrated, rapid, compact, device containing a polymerase chain reaction (PCR)-based nucleic acid amplification test (NAAT) for accurate, qualitative detection and differentiation of deoxyribonucleic acid (DNA) for Neisseria gonorrhea (NG), Trichomonas vaginalis (TV), and Chlamydia trachomatis (CT) organisms.
Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The study population comprises female subjects greater than or equal to 14 years of age
        visiting any of the participating clinics for any reason, who may be symptomatic or
        asymptomatic for STIs at locations including but not limited to: OB/GYN and primary care
        offices, as well as sexually transmitted disease, teen, public health, and family planning
        clinics. Any subject who meets the inclusion/exclusion criteria is eligible to participate
        in this study.
A Study to Evaluate the Efficacy and Safety of Reslizumab in Patients With Eosinophilic Asthma
Condition: Eosinophilic Asthma
MeSH terms: Asthma; Pulmonary Eosinophilia
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of this study is to determine whether reslizumab is more effective than
      placebo in reducing the number of clinical asthma exacerbations (CAEs) in patients with
      eosinophilic asthma.
    


Intervention name(s): Reslizumab; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Patients were administered intravenously over 15 to 30 minutes reslizumab at a dosage of 3.0 mg/kg at baseline and once every 4 weeks relative to baseline over 48 weeks for a total of 13 doses.; Matching placebo (acetate sucrose buffer), administered intravenously (iv) once every 4 weeks for a total of 13 doses.
Other intervention name(s): Cinquil; humanized monoclonal antibody; CEP-38072
Intervention MeSH terms: Reslizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Ascending Multiple-Dose Study to Evaluate VIA-3196 in Healthy Subjects
Condition: Drug Safety
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single-center, randomized, double-blind, placebo-controlled, ascending
      multiple-dose study of VIA-3196 to evaluate the Safety, Pharmacokinetics and Pharmacodynamics
      of VIA-3196 in Healthy Subjects. Study dosing is organized into cohorts corresponding to
      escalating doses of VIA-3196 or matching placebo. Subjects will be dosed daily for 14 days.
    


Intervention name(s): Placebo; VIA-3196
Intervention type(s): Drug; Drug
Intervention description(s): Oral, daily-dosing for 14 days; matching number of placebo capsule(s) with active arm; Oral, daily dosing for 14 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Metabolic Profile and Anthropometric Changes in Schizophrenia
Condition: Metabolic Syndrome; Diabetes; Obesity
MeSH terms: Metabolic Syndrome; Schizophrenia
Study type: Interventional

Summary: 
      "No clinical differences will be found between the three antipsychotics under study -
      olanzapine, risperidone and haloperidol - on the patients' metabolic profile and weight. "
    

Detailed description: 
      we aimed to study the effects of antipsychotics, olanzapine, risperidone and haloperidol on
      development of metabolic syndrome in a drug naïve population suffering from first episode
      schizophrenia and compared it with a matched healthy control group. We also aimed to examine
      the prevalence of metabolic syndrome as defined by the two most widely accepted definitions,
      the ATP IIIA and the IDF.
    

Intervention name(s): Olanzapine; Risperidone; Haloperidol
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Olanzapine in dose range of 10-20mg; Risperidone 1-6mg; Haloperidol 10-20mg
Intervention MeSH terms: Haloperidol; Olanzapine; Risperidone; Haloperidol decanoate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Screening
Keywords: Metabolic syndrome; Obesity; Diabetes
A Single-Dose Study of the Safety and Tolerability of REGN475(SAR164877) in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, double-blind, placebo-controlled single-dose study of the safety and
      tolerability of intravenously administered REGN475 in healthy volunteers. The primary
      objective of the study is to assess the safety and tolerability of REGN475. The secondary
      objectives are to characterize the pharmacokinetic and immunogenicity profiles of REGN475.
    


Intervention name(s): REGN475 (SAR164877)
Intervention type(s): Biological
Intervention description(s): Subcutaneous administration REGN475 (SAR164877)
Intervention MeSH terms: Fasinumab
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Healthy volunteers
Sustainability of MOVE UP Lifestyle Intervention
Condition: Body Weight; Diet, Healthy; Physical Disability
MeSH terms: Body Weight
Study type: Interventional

Summary: 
      In prior research the investigators have shown that the Mobility and Vitality Lifestyle
      Program for healthy aging and weight management (MOVE UP) was effective in producing a mean
      loss of >= 5% body weight, with increased physical activity and reduced fatigue. The current
      study will pilot a modified and streamlined program to see if it will be similarly effective.
    

Detailed description: 
      The investigators aim to test feasibility of Community Health Worker delivery of a modified
      and streamlined lifestyle program in volunteer community settings and to provide pilot data
      to inform the design of future randomized controlled trials that may improve physical and
      mental health in older adults. The current objective is to:

        1. Adapt and pilot the previously studied 32-session, 13-month MOVE UP intervention to a
           streamlined 12-session (4-month) community-based translational behavioral weight
           management program. The pilot program will be delivered by trained Community Health
           Workers (CHWs).

        2. Implement and evaluate the program's impact on weight and healthy lifestyle changes,
           including physical performance outcomes, at 2 sites, each with at least 6 eligible obese
           adults ages 60-75 years old.
    

Intervention name(s): MOVE UP
Intervention type(s): Behavioral
Intervention description(s): Each of the 12-group-sessions will focus on incremental behavioral strategies for maintaining recommended healthy eating, activity, and weight loss behaviors. Participants will monitor body weight and weight loss behaviors. Body weight will be measured at each in-person session and participants will also be encouraged to measure their body weight on their own. Beginning in Session 3, participants are given a home physical activity goal of 10 minutes/day, 50 minutes/week. The goal is raised by 5 minutes/day, 25 minutes/week every other session, the final goal being 30 minutes/day, 150 minutes/week. All subjects will be recommended to engage in an energy restricted dietary intervention that evidence demonstrates has effectively reduced body weight by 5-7% within the initial 4 months of the intervention. This will include reducing energy intake to 1200 to 1800 kcal/d based on initial body weight (<200 pounds = 1200 kcal/d; 200 to 250 pounds = 1500 kcal/d; >250 pounds = 1800 kcal/d).
Intervention model: Single Group Assignment
Intervention model description: Implementation research for adapted effective intervention
Masking: None (Open Label)
Primary purpose: Prevention
PegIntron Treatment of Chronic Hepatitis B e Antigen-Positive Patients (P05170/MK-4031-327)
Condition: Hepatitis B, Chronic
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine the efficacy and safety of two dosages of PegIntron
      for treating hepatitis B e antigen (HBeAg) positive chronic hepatitis B compared with the
      approved dosage, which is PegIntron 1.0 microgram (mcg)/kg given once a week for 24 weeks.
      This study compares dosages of (1) 1.5 mcg/kg once a week for 24 weeks and (2) 1.5 mcg/kg
      once a week for 48 weeks with the approved dosage. All subjects are followed for 24 weeks
      after their treatment ends.
    


Intervention name(s): pegylated interferon alpha-2b; pegylated interferon alpha-2b; pegylated interferon alpha-2b
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 1.0 mcg/kg subcutaneously (S.C.) QW for 24 weeks; 1.5 mcg/kg S.C. QW for 24 weeks; 1.5 mcg/kg S.C. QW for 48 weeks
Intervention MeSH terms: Interferons; Interferon-alpha; Interferon alpha-2; Peginterferon alfa-2b
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Digestive Endoscopy Suite Radiation Controlling Protective Strategies
Condition: Radiation Exposure
Study type: Interventional
Phase: Early Phase 1

Summary: 
      ERCP is associated with radiation exposure to the endoscopist and staff, which may be
      significant at high volume programs despite the use of lead aprons. We hypothesize that
      draping of the fluoroscopy image intensifier may significantly reduce staff radiation
      exposure and help achieve implementation of the ALARA (As Low As Reasonably Achievable)
      principle.
    

Detailed description: 
      A total of 100 consecutive ERCP procedures were randomly assigned to the
      radiation-attenuating or sham drape in a 1:1 ratio. There were 2 subjects, the endoscopists
      performing ERCP and the nurse assisting in the procedure.
    

Intervention name(s): lead-free protective drape containing bismuth and antimony (RADPAD®); sterile identical sham drape
Intervention type(s): Device; Device
Intervention MeSH terms: Bismuth
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Development of Immunological Assays for the Evaluation of Tumor Antigen Specific Immunity
Condition: Ovarian Serous Adenocarcinoma; Undifferentiated Carcinoma of Ovary; Cervical Cancer; Cervical Intraepithelial Neoplasia, Grade 3; Acute Myeloid Leukemia; Chronic Myeloid Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Uterine Cervical Neoplasms; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Uterine Cervical Dysplasia; Cystadenocarcinoma, Serous; Carcinoma
Study type: Observational

Summary: 
      This study is a clinical study aiming at establishing immunological assays for the
      qualitative and quantitative evaluation of WT-1, Survivin and HPV16 E7-specific immune
      responses in cancer patients. Such a study will allow the development of suitable
      immunological tools to be used in assessing response in a subsequent phase I study aiming at
      evaluating therapeutic vaccine candidates targeting WT-1, Survivin and/or HPV16 E7-expressing
      tumors. In addition, this study will help defining the baseline cancer-associated immune
      responses in the selected patient population.

      Cervical and ovarian cancer patients, as well as leukemia patients, will be included in this
      study.

      WT-1, Survivin and HPV-specific immune responses will be monitored in these patients by ex
      vivo and cultured IFNg ELISpot as well as tetramer staining.
    


Intervention name(s): Blood Sampling
Intervention type(s): Procedure
Intervention description(s): Sampling of 80mL of whole blood
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Three type of patients will be enrolled in this study:

          -  Women with a confirmed diagnosis of serous or undifferentiated ovarian cancer

          -  Women with a confirmed diagnosis of CIN3 or cervical cancer

          -  HLA-A2 positive men or women with a confirmed diagnosis of AML of CML All these
             patients will be less than 70 years of age and will show no evidence of active
             progressive disease on follow up. For ovarian cancer patients, a woman with a rising
             CA125 and negative imaging is acceptable.
      
Biospecimen description: 
      PBMCs isolated from whole blood
    
Keywords: Ovarian Cancer; Cervical Cancer; Leukemia; Immunity; WT-1; Survivin; HPV
Effects of Cardiac Rehabilitation on Postoperatory of Coronary Artery Bypass Graft.
Condition: Complication of CABG
Study type: Interventional
Phase: Phase 3

Summary: 
      Randomized Clinical Trial to evaluate the use of different techniques of physical therapy on
      recovery of functional capacity, pulmonary function and respiratory muscle strength in the
      period of hospital stay after coronary artery bypass graft.
    


Intervention name(s): Combination of four techniques of physiotherapy; Combination of three techniques of physiotherapy; Combination of two techniques of physiotherapy; standard therapy
Intervention type(s): Other; Other; Other; Other
Intervention description(s): The patients receive conventional physiotherapy, expiratory positive airway pressure, inspiratory muscle training and physical exercise. Twice daily for seven days; Patients receive conventional physiotherapy, expiratory positive airway pressure and physical exercise. Twice daily for seven days; Patients receive conventional physiotherapy,expiratory positive airway pressure respiratory muscle training. Twice daily for seven days; Patients receive conventional physiotherapy and expiratory positive airway pressure. Twice daily for seven days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Supportive Care
Combining Performance of Call EMS and Simultaneous Chest Compressions in a Lone Rescuer CPR
Condition: Out-of-Hospital Cardiac Arrest
MeSH terms: Out-of-Hospital Cardiac Arrest
Study type: Interventional

Summary: 
      Investigators designed the novel combining technique that rescuer start the chest compression
      with one hand during calling for help to the Emergency Medical System (EMS) via a cell phone
      with another hand when he witnessed the arrest victim. This method may be helpful to reduce
      the hand-off time and increase the faction time of chest compression until the arrival of EMS
      members.

      To verify this hypothesis, we conducted a random, controlled simulation study.
    

Detailed description: 
      This study used a random, controlled design in the simulation setting using a manikin. Study
      participants were recruited from healthy adult (age > 18 years) laypersons who attended the
      BLS training courses provided by the BLS training class.

      The simulation scenario consists of witness of an out of hospital cardiac arrest and
      activation of the EMS system with the prepared cellular phone. Interventional method
      contained the immediate starting of the chest compression with one hand during the calling
      for help to the EMS via a cell phone with another hand.

      We compare the quality of CPR between the novel interventional method (start CPR during Call
      to EMS) and conventional method (First Call to EMS and then start CPR).
    

Intervention name(s): Combi lone-CPR; Conventional lone-CPR
Intervention type(s): Behavioral; Behavioral
Intervention description(s): When study participants meet the arrest victim (simulated), they start chest compression and call for help to EMS at the same time, then continue the chest compression and 2 breath alternatively until the EMS arrival; When study participants meet the arrest victim (simulated), they first call for help to EMS and then start chest compression and 2 breath alternatively until the EMS arrival
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cardiopulmonary Resuscitation; Emergency Medical Services; Cell phones; Simulation Training