bioihbjkbjnl/mcl2 huggingface dataset:
The Effect of Tocilizumab on Procalcitonin and Other Biochemical and Clinical Markers in the Setting of COVID-19 Pneumonia
Condition: COVID-19 Pneumonia; ARDS
MeSH terms: COVID-19; Pneumonia
Study type: Observational

Summary: 
      This study aims to establish whether tocilizumab has any significant effect on procalcitonin
      levels on patients diagnosed with COVID-19 pneumonia requiring intensive care admission. The
      effects on other biochemical and clinical markers are also considered.
    

Detailed description: 
      A retrospective study, involving the first fifty patients treated with tocilizumab for acute
      deterioration in COVID-19 pneumonia in the Intensive Care Unit (ICU) at Mater Dei Hospital in
      Malta.

      The following parameters will be collected from medical records:

        -  procalcitonin levels, daily for twenty days or until discharge or death.

        -  namely white cell count (WCC), neutrophils, lymphocytes,

        -  C-reactive protein (CRP)

        -  PaO2/FiO2 ratio (P/F ratio).

      This group will be compared to a control group was chosen from patients admitted to the ICU
      who were not eligible for tocilizumab treatment, matched to the study group for age, gender,
      mode of ventilation required and length of stay in ICU.
    

Intervention name(s): Tocilizumab
Intervention type(s): Drug
Intervention description(s): Tocilizumab administered at a dose of 8mg/kg up to a maximum of 800mg
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        COVID-19 patients treated with tocilizumab single dose therapy in ICU
      
Keywords: COVID-19 Pneumonia; Tocilizumab; Procalcitonin; C-Reactive Protein
ABCA2 GIRMS Analytical Validation Clinical Performance Study
Condition: Gastroparesis
MeSH terms: Gastroparesis
Study type: Interventional

Summary: 
      The purpose of this study is to collect human breath samples for use in a validation study
      intended to demonstrate equivalent clinical performance measures of new ABCA2 GIRMS
      (Automated Breath Carbon Analyzer-2 Gas Isotope Ratio Mass Spectrometer) instruments to the
      currently FDA-approved ABCA GIRMS (Automated Breath Carbon Analyzer Gas Isotope Ratio Mass
      Spectrometer) system. ABCA GIRMS systems are used to analyze the ratio of 13CO2 to 12CO2 in
      patient breath samples during the GEBT (Gastric Emptying Breath Test) procedure.
    

Detailed description: 
      In this study the participants will be administered the FDA-approved GEBT test, which
      involves collecting breath samples prior to and after consumption of a non-radioactive carbon
      stable isotope (13C) labeled test meal. Breath samples will be collected at times consistent
      with FDA approved labeling. Participant's breath samples will be analyzed on the currently
      approved ABCA GIRMS and on the new ABCA2 GIRMS instruments. The values collected from both
      systems will be used to determine the clinical diagnostic agreement at each individual time
      points and percent agreement in diagnosis between the approved ABCA GIRMS and the new ABCA2
      GIRMS.
    

Intervention name(s): ABCA2 GIRMS
Intervention type(s): Device
Intervention description(s): Two systems (ABCA-C and ABCA-D) with run order randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Gastroenterology; Gastric Emptying Breath Test
Emergency Department Healthcare Education Assessment and Response for Teen Relationships: A Pilot Feasibility Study
Condition: Adolescent Behavior; Emergency Department; Abuse Physical; Abuse Mental; Abuse Verbal; Abuse Domestic; HEART; Intimate Partner Violence
MeSH terms: Emergencies
Study type: Interventional

Summary: 
      This is a single-site, randomized, controlled trial. Investigators will evaluate feasibility
      of the Emergency Department Healthcare Education Assessment and Response for Teen
      Relationships (ED-HEART) intervention among adolescents age 14-19 years receiving care in the
      Children's Mercy emergency department.
    

Detailed description: 
      This study is a mixed methods feasibility evaluation that will use a randomized controlled
      trial to assess feasibility of Emergency Department Healthcare Education Assessment and
      Response for Teen Relationships (ED-HEART) (intervention arm: ED-HEART + teen resource list;
      control arm: enhanced standard care [standard care + teen resource list]). Adolescents age
      14-19 years will be recruited and enrolled during an emergency department visit.
      Investigators will evaluate feasibility using the eight Bowen model feasibility constructs:
      acceptability, demand, implementation, practicality, adaptation, integration, expansion, and
      limited-efficacy testing. Investigators will also examine theory of planned behavior
      constructs (attitudes, beliefs, perceived behavioral control, intention) to facilitate
      exploratory analysis of factors that may contribute to differential outcomes.
    

Intervention name(s): ED-HEART
Intervention type(s): Behavioral
Intervention description(s): Behavioral intervention that assesses 1) healthy and unhealthy relationship behaviors, 2) conversation with partners around boundaries within relationships, 3) harm reduction strategies, and 4) resources for Adolescent Relationship Abuse (ARA) and related concerns, including Point of Care (POC) Reproductive and Sexual Health (RSH) harm reduction resources.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Adolescents will be enrolled in one of two arms: Emergency Department Healthcare Education Assessment and Response for Teen Relationships (ED-HEART) (intervention arm) or Enhanced Usual Care (control arm). Adolescents will complete study surveys at baseline (Baseline Survey; intervention and control arms), immediately post-intervention (Exit Survey, intervention arm), and 12 weeks after intervention delivery (Follow-up Survey, intervention and control arms).
Masking: None (Open Label)
Primary purpose: Other
Effects of Preventive Treatment for Respiratory Syncytial (RS) Virus Infection During Infancy on Later Atopic Asthma in Preterm Infants
Condition: Atopic Asthma; Recurrent Wheezing
MeSH terms: Virus Diseases; Asthma; Respiratory Sounds
Study type: Observational

Summary: 
      The primary objective of the study is to determine whether the incidence of atopic asthma
      after three years old may be suppressed in the children who were born as preterm infants and
      prophylactically treated with palivizumab for respiratory syncytial (RS) virus infections
      during the infancy.

      The secondary objective is to determine whether the incidence of recurrent wheezing after
      three years old may be suppressed in the children who were born as preterm infants and
      prophylactically treated with palivizumab for RS virus infections during the infancy.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The children who are participating in another on-going study, "Effect of Palivizumab on
        Later Recurrent Wheezing in Preterm Infants (ClinicalTrials.gov Identifier: NCT01072552)"
        and whose parents or legal guardian provide informed consent in writing for continuing
        participation in the study.
      
Biospecimen description: 
      The serum samples
    
Keywords: atopic asthma; recurrent wheezing; preterm infants; palivizumab; respiratory syncytial virus; RSV
MK-7625A Plus Metronidazole Versus Meropenem in Pediatric Participants With Complicated Intra-Abdominal Infection (cIAI) (MK-7625A-035)
Condition: Complicated Intra-Abdominal Infection
MeSH terms: Infections; Communicable Diseases; Intraabdominal Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      This study aims to evaluate the safety and tolerability of MK-7625A (ceftolozane/tazobactam)
      plus metronidazole, compared with that of meropenem in pediatric participants with cIAI.
    


Intervention name(s): Ceftolozane/Tazobactam; Metronidazole; Meropenem; Placebo for Metronidazole
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Ceftolozane 20 mg/kg (maximum 1 g) and tazobactam 10 mg/kg (maximum 0.5 g/dose) administered IV every 8 hours for between 5 to 14 days.; Metronidazole 10 mg/kg (maximum 1.5 g/day) administered IV every 8 hours for between 5 to 14 days. Participants ≤ 28 days old, start with a loading dose of 15 mg/kg; then if ≤ 2 kg are dosed 7.5 mg/kg/ every 12 hours; or if > 2 kg are dosed 10 mg/kg every 8 hours.; Meropenem 20 mg/kg (maximum 1 g/dose) administered IV every 8 hours for between 5 to 14 days.; Placebo for metronidazole administered IV every 8 hours for between 5 to 14 days.
Other intervention name(s): MK-7625A; MERREM
Intervention MeSH terms: Metronidazole; Meropenem; Tazobactam; Ceftolozane; Ceftolozane, tazobactam drug combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Physiotherapy for Chronic Metatarsalgia
Condition: Metatarsalgia
MeSH terms: Metatarsalgia
Study type: Observational

Summary: 
      The pilot study was conducted in the form of an open prospective single-arm observational
      study with 28 patients who received physiotherapy at the Spiraldynamik® Med Center in Zurich.
    

Detailed description: 
      The pilot study was conducted in the form of an open prospective single-arm observational
      study. The data of 28 patients who received physiotherapy at the Spiraldynamik® Med Center in
      Zurich was evaluated. The endpoints of Visual Analog Scale Foot and Ankle (VAS FA), Activity
      Index (AI), plantar and inter-metatarsal pres-sure pain, rearfoot angle and dorsal extension
      capability of the upper ankle joint were individually compared and analyzed before and after
      therapy.
    

Intervention name(s): physiotherapy
Intervention type(s): Other
Intervention description(s): physiotherapeutic intervention according to the principles of the Spiraldynamik® concept
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        patients with chronic metatarsalgia
Long-term Extension Study of SM-13496 (Lurasidone HCl) in Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 3

Summary: 
      The study evaluates the long term safety and efficacy of SM-13496 in patients with
      schizophrenia.
    


Intervention name(s): SM-13496
Intervention type(s): Drug
Intervention description(s): 40 or 80 mg once daily orally
Intervention MeSH terms: Lurasidone Hydrochloride
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Effectiveness of Immunotherapy With Autologous HIV-Specific CD8 Cells in HIV Infected Adults
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      Effective, suppressive treatment for HIV infected patients can be a major challenge because
      HIV progressively destroys their immune systems. CD8 cells isolated from a patient's blood
      and grown in large numbers in the laboratory may increase a patient's immune system response
      to HIV. The purpose of this study is to determine if CD8 cells will provide effective
      antiviral activity against HIV when transplanted back in large numbers into HIV infected
      patients.

      Study hypothesis: There are specific cells in the immune system that recognize and can kill
      HIV-infected cells.
    

Detailed description: 
      The function of CD8 cells in the human body is to kill infected target cells, such as HIV
      infected cells. Recent data suggest that intravenous administration of HIV-specific CD8 cells
      is safe, augments host immunity, and mediates a dramatic reduction in circulating
      HIV-infected CD4 cells. However, the observed antiviral effects are transient, and HIV
      infected CD4 cells re-emerge as the number of self CD8 cells declines. Augmenting CD8 cell
      response to HIV by immunotherapy with CD8 cells may be a useful addition to drug therapy if
      the infused CD8 cells can survive long-term in vivo. Administration of interleukin-2 (also
      known as aldesleukin or IL-2), a naturally occurring cytokine, has been proposed as a way to
      maintain the number of CD8 cells. This study will evaluate the safety and efficacy of
      immunotherapy with HIV-specific CD8 cells in HIV infected patients. Additionally, this study
      will determine if aldesleukin injections improve the persistence of self CD8 transplants and
      the duration of antiviral activity without severe toxicity.

      This study will last 18 months. CD8 cells will be isolated from the blood of HIV infected
      patients; the cells will be allowed to multiply in the laboratory, and patients will receive
      back their CD8 cells. Patients will receive up to 3 infusions of self CD8 cells. On Day 0,
      patients will receive their first infusion of CD8 cells. On Day 7, patients will receive
      their second infusion of CD8 cells; this infusion will be followed by 14 days of aldesleukin
      administered daily by injection under the skin. Patients with less than a Grade 2 toxicity
      will receive a third infusion of CD8 cells; this infusion will be followed by 21 days of
      aldesleukin.
    

Intervention name(s): Adoptive transfer of HIV-specific CD8+ T cells; Aldesleukin
Intervention type(s): Procedure; Drug
Intervention MeSH terms: Aldesleukin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Treatment Naive; Treatment Experienced
A Clinical Study to Evaluate the Safety and Efficacy of Elagolix in Participants With Moderate to Severe Endometriosis-Associated Pain
Condition: Endometriosis
MeSH terms: Endometriosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this study is to evaluate safety and efficacy of elagolix in the management
      of moderate to severe endometriosis-associated pain in adult premenopausal female
      participants including the safety and efficacy of elagolix in combination with concomitant
      hormonal add-back therapy.
    


Intervention name(s): Estradiol/Norethindrone Acetate; Placebo for Elagolix; Elagolix; Placebo for E2/NETA
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Tablets; Tablet; Tablet; Tablets
Other intervention name(s): Activella; E2/NETA; ABT-620; Elagolix Sodium; ORILISSA
Intervention MeSH terms: Norethindrone; Norethindrone Acetate; Estradiol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Elagolix; Endometriosis associated pain; Dysmenorrhea (DYS); Non-menstrual pelvic pain (NMPP); ORILISSA
Prevention Management Model for Early Childhood Caries (MAYA Project)
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether dental disease patterns and transmissable
      bacteria that are known to cause a severe form of dental decay in young children can be
      reduced or eliminated by treating mothers and their young infants early on with Chlorhexidine
      and fluoride varnish applications, respectively as part of a comprehensive Prevention
      Management Model.
    

Detailed description: 
      The primary aim is to evaluate two programs, a minimal intervention program and a moderate
      intensity program, for preventing Early Childhood Caries. A four-year randomized clinical
      trial will be conducted specifically to: 1) Assess demographic and behavioral factors as
      predictors of ECC and the relationship between three-year post-intervention behavioral
      changes from baseline measures with disease outcomes; 2) Compare the efficacy for the
      prevention of ECC in two groups - the minimal intervention group (Group 1) receiving
      counseling alone, with the moderate intensity group (Group 2) receiving a) counseling and a
      therapeutic four-month regimen of Chlorhexidine rinse for new mothers and b) fluoride varnish
      applications for their infants and toddlers starting at twelve months of age and continuing
      to age 30 months; 3) Assess baseline salivary microbiological markers as predictors of ECC in
      the infants of women in both groups and the relationship between three-year post-intervention
      salivary markers and changes from baseline measures with disease outcomes; 4) Assess the
      impact of a caries-preventive model in lowering the salivary mutans streptococci level in
      post-partum women, and subsequently, in inhibiting the growth of these bacteria in their
      young children, delaying the infectious process.

      The long term objectives are to build upon our understanding of caries risk factors, to
      assess the effectiveness of a prevention management model, to improve access to preventive
      oral health services and information for low-income pregnant women and their young children,
      and to reduce oral health disparities in a border population (U.S. - Mexico Border near San
      Diego Bay Area) at high risk for dental disease.
    

Intervention name(s): Chlorhexidine gluconate; Fluoride Varnish
Intervention type(s): Drug; Device
Intervention description(s): 0.5oz chlorhexidine gluconate 0.12% solution mouth rinse twice daily for 14 days then no rinse for 14 days, repeated for 3 months; 0.25ml FV every 6 months from age 12 to 30 months
Other intervention name(s): Peridex® OMNII Oral Pharmaceuticals; CavityShield® OMNII Oral Pharmaceuticals
Intervention MeSH terms: Chlorhexidine; Chlorhexidine gluconate; Fluorides; Fluorides, Topical
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Early childhood caries
Observational Study of Azilsartan/Chlorthalidone and Irbesartan/Hydrochlorothiazide in Hypertension and Obesity.
Condition: Arterial Hypertension
MeSH terms: Hypertension; Obesity
Study type: Observational

Summary: 
      This is an observational prospective study of azilsartan medoxomil / chlorthalidone compared
      with irbesartan / hydrochlorothiazide in routine therapy of patients with arterial
      hypertension and obesity.
    

Detailed description: 
      Observational Prospective stUdy of aZilsartan medoxomil/ chlorthalidone compared with
      irbesartan/hydrochlorothiaZide combination therapy in patients with arteriaL hypertension and
      obEsity in routine clinical practice (PUZZLE).

      The study population is 94 patients with untreated or poorly controlled arterial hypertension
      and obesity.

      The main inclusion criteria are:

        1. Male and female 35-55 year old.

        2. Diagnosis of essential arterial hypertension I-II grade.

        3. Patients with obesity (BMI ≥ 30 kg/m²)

        4. Patients with untreated arterial hypertension (clinic SBP ≥ 140 mmHg, DBP ≥ 90 mmHg and
           no previous antihypertensive treatment.

        5. Patients with poorly controlled arterial hypertension (clinic SBP ≥ 140 mmHg, DBP ≥ 90
           mmHg on previous antihypertensive treatment.

        6. Written informed consent.

      The main exclusion criteria are:

        1. Patients with symptomatic organ damage (myocardial infarction, stroke, angina pectoris,
           chronic kidney disease ≥ 4 grade, diabetes).

        2. Patients with secondary arterial hypertension.

        3. Patients with intolerance of angiotensin II receptor blockers, thiazide diuretic.

        4. Patients with contraindication to study drugs in accordance with Russian instruction.

        5. Patients currently enrolled in other clinical trials. The treatment period is 6 months.
           The study plan includes 4 basic and 1 additional visits are planned: initial visit, 3
           follow-ups (including additional) and study-end visit.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The study population is 94 patients with untreated or poorly controlled arterial
        hypertension and obesity 35-55 years old.
      
Keywords: Obesity
Safety Study of BMS-770767 in Subjects With Hypercholesterolemia
Condition: Dyslipidemia
MeSH terms: Hypercholesterolemia; Dyslipidemias
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the safety, tolerability and pharmacodynamic effects
      on LDL cholesterol (LDL-C)
    


Intervention name(s): BMS-770767; BMS-770767; BMS-770767; BMS-770767; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Active, Oral, 15 mg, Daily, 28 days; Active, Oral, 50 mg, Daily, 28 days; Active, Oral, 150 mg, Daily, 28 days; Active, Oral, 50 mg BID, Daily, 28 days; Placebo, Oral, 0 mg, daily, 28 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Dosing Study of Remifentanil for Smooth Removal of the Laryngeal Mask Airway (LMA)
Condition: Drug Usage
Study type: Interventional
Phase: Phase 4

Summary: 
      The investigators attempted to determine the optimal effect-site concentration of
      remifentanil for smooth removal of the LMA from propofol anesthesia.
    

Detailed description: 
      At the end of the surgery, propofol infusion was stopped and remifentanil was titrated to
      predetermined (initial concentration 1.0 ng/ml for the first patient). LMA removal was
      performed when the patients opened their eyes and spontaneous respiration and adequate tidal
      volume and ventilatory frequency were confirmed.
    

Intervention name(s): remifentanil; laryngeal mask airway (LMA)
Intervention type(s): Drug; Device
Intervention description(s): The concentration of remifentanil was determined by modified Dixon's up-and-down method, starting from 1.0 ng/ml (0.2 ng/ml as a step size); LMA was removed when the patients opened their eyes, and spontaneous respiration and adequate tidal volume and ventilatory frequency were confirmed
Other intervention name(s): Ultiva
Intervention MeSH terms: Remifentanil
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: LMA removal; remifentanil; propofol