bioihbjkbjnl/mcl2 huggingface dataset:
Sanofi Pasteur's Tdap Combined Vaccine as a Booster Versus Local DT Vaccine in Children or Versus Local Td Vaccine in Adolescents and Adults in China.
Condition: Diphtheria; Tetanus; Pertussis
MeSH terms: Whooping Cough; Tetanus; Diphtheria
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of the study is to assess the immunogenicity and safety profile of ADACEL compared to
      local adsorbed diphtheria and tetanus combined vaccine (local DT or local Td vaccine in
      participants in China.

      Primary objective:

        -  To describe diphtheria and tetanus seroprotection rates and pertussis booster response
           rates induced by each of the study vaccines: ADACEL vaccine (in all study age groups),
           local DT vaccine (in children), and local Td vaccine (in adolescents and adults).

      Secondary Objectives:

        -  To further describe in each group the immunogenicity of the study vaccines at baseline
           and 1 month after vaccination.

        -  To describe the safety of the study vaccines
    

Detailed description: 
      Study participants will receive a single booster dose of ADACEL (Tdap vaccine) or a single
      booster dose of local DT or local Td vaccine, depending on the age subgroup.

      Immunogenicity will be assessed before and 28 days post-vaccination; safety profile will be
      assessed in all subjects up to Day 35 post vaccination.
    

Intervention name(s): Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed Tdap (ADACEL); DT vaccine (Diphtheria and Tetanus Combined Vaccine, Adsorbed); Td vaccine (Diphtheria and Tetanus Combined Vaccine for Adults and Adolescents, Adsorbed)
Intervention type(s): Biological; Biological; Biological
Intervention description(s): 0.5 mL, Intramuscular; 0.5 mL, Intramuscular; 0.5 mL, Intramuscular
Other intervention name(s): ADACEL
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Diphtheria; Tetanus; Pertussis; ADACEL®; Tdap vaccine
Safety and Efficacy of Vortioxetine (Lu AA21004) in Adults With Major Depressive Disorder
Condition: Depressive Disorder, Major
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy, safety and tolerability of
      vortioxetine, once daily (QD), compared with placebo in adults with major depressive
      disorder.
    

Detailed description: 
      The drug that was tested in this study is called Vortioxetine. Vortioxetine is being tested
      to treat depression in adults who have major depressive disorder (MDD). This study looked at
      MDD relief in people who took varying dosages of vortioxetine.

      The study enrolled 614 patients. Participants were randomly assigned (by chance, like
      flipping a coin) to one of the four treatment groups-which remained undisclosed to the
      patient and study doctor during the study (unless there was an urgent medical need):

        -  Vortioxetine 15 mg

        -  Vortioxetine 20 mg

        -  Duloxetine 60 mg

        -  Placebo (dummy inactive capsule) - this was a capsule that looked like the study drug
           but had no active ingredient.

      All participants were asked to take one capsule at the same time each day throughout the
      study.

      This multi-center trial was conducted in the United States. The overall time to participate
      in this study was up to 13 weeks. Participants made 9 visits to the clinic, and were
      contacted by telephone 4 weeks after the last dose of study drug for a follow-up assessment.
    

Intervention name(s): Vortioxetine; Duloxetine; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Encapsulated vortioxetine immediate release tablets; Overencapsulated duloxetine delayed-release capsules; Placebo-matching capsules
Other intervention name(s): Lu AA21004; Brintellix®; Cymbalta®
Intervention MeSH terms: Duloxetine Hydrochloride; Vortioxetine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Major Depressive Disorder; Depression; Melancholia; Drug Therapy
Parental Knowledge and Beliefs About Infant Sleep Position
Condition: Sudden Infant Death Syndrome
MeSH terms: Infant Death; Sudden Infant Death
Study type: Interventional

Summary: 
      In the United States, Sudden Infant Death Syndrome (SIDS)is the leading cause of death in
      infants between the ages of 1 and 12 months. The etiology of SIDS is still not clear although
      a number of risk factors have been identified. Sleeping on the stomach has been identified as
      a major risk for SIDS. The rates of SIDS have dropped substantially in countries in which the
      usual sleep position has changed from the stomach to the side or back. Back sleep has been
      shown to be the most stable and safest position. The American Academy of Pediatrics now
      recommends the back sleeping position for all healthy infants. Since the American Academy of
      Pediatrics began advocating the back sleep position, the incidence of SIDS has decreased by
      more than 40% in this country. However, the decrease has not been uniform across segments of
      the population. Black infants continue to have a higher rate of SIDS compared with other
      groups. This discrepancy could be related to infant sleep position practices. Several studies
      have shown that infants born to low income, minority, inner-city families were more likely to
      be placed on the stomach to sleep. Education appears to influence choice of sleep position
      and may explain, at least to some degree, the difference in choice of sleep position among
      certain groups. We believe that uniform education of parents will influence the sleep
      position that parents choose for their baby. We will undertake this initial study to document
      what parents choose to do with their infants regarding sleep position and why they make these
      choices so that we can improve our educational approach.
    


Intervention name(s): Parental knowledge and beliefs about infant sleep position
Intervention type(s): Behavioral
Primary purpose: Educational/Counseling/Training
Placebo Development and Validation for Healing Water
Condition: Balneology
Study type: Interventional

Summary: 
      The study aimed to develop and validate an easy-to use cheap method capable of producing
      placebo from tap water.
    

Detailed description: 
      Introduction: The beneficial health effects of healing waters have been reported by numerous
      studies. However, the lack of proper placebo substance makes the "medication-like"
      investigation of healing waters difficult. The investigators aimed to develop and validate an
      easy-to use cheap method capable of producing placebo from tap water.

      Methods: Both medical water and tap water will be colored. The temperature and the pH of the
      tap water will be adjusted to the temperature pH of the healing water. The patients will be
      divided into two groups, colored healing water and placebo group. A single 20 minutes-long
      treatment will be performed in bath tubs. Considering the healing waters odor, the treatment
      will be given in the same room. Patients will be asked to tell whether they are treated with
      colored healing water or placebo or could not tell. Questions will be asked before the
      treatment, 10 minutes after the beginning of the treatment, immediately after the end of the
      treatment and after shower. The study will be performed in a double blind setup. Patients
      will be scored, one point for each correct answer.

      Target patient number:174
    

Intervention name(s): Colored healing water; Placebo treatment (colored tap water)
Intervention type(s): Other; Other
Intervention description(s): Patients will be treated with colored healing water for 20 minutes.; Patients will be treated with colored tap water for 20 minutes.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: double blind study for testing a placebo development method
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Other
Keywords: medical water; healing water; placebo
Effectiveness of Eplerenone to Improve Target Organ Damage in Patients With Resistant Arterial Hypertension
Condition: Essential Hypertension
MeSH terms: Hypertension; Essential Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      Resistant hypertension is defined as hypertension not controlled (i.e. blood pressure not
      below 140/90 mmHg) with the use of adequate doses of at least three different
      anti-hypertensives including a diuretic. Resistant hypertension is abundant. In the ALLHAT
      trial 34% of patients did not reach the blood pressure goal of 140/90 mmHg. One possible
      mechanism of resistance is the aldosterone-escape phenomenon.

      During aldosterone escape, aldosterone plasma levels are normal or even elevated despite
      therapy with ACEIs or ARBs. The prevalence is about 30-50%. Possible reasons for aldosterone
      escape are alternative ways of aldosterone stimulation (hyperkalemia, adrenomedullin, ACTH),
      local aldosterone production or primary aldosteronism. Aldosterone has deleterious blood
      pressure independent effects on cardiac, vascular and renal damage.

      Hypothesis: Eplerenone is effective to improve hypertensive target organ damage in patients
      with resistant hypertension.
    

Detailed description: 
      see above
    

Intervention name(s): placebo; eplerenone
Intervention type(s): Drug; Drug
Intervention description(s): od; 50mg od
Intervention MeSH terms: Eplerenone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Essential hypertension
Tolerability, Efficacy, and PK of ZSP1601 in Patients With Non-Alcoholic Steatohepatitis (NASH)
Condition: Non-Alcoholic Steatohepatitis (NASH)
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Double-blind, randomized, placebo-controlled study to explore the safety, tolerability PK
      characteristics and early efficacy of ZSP1601 tablets in patients with non-alcoholic
      steatohepatitis (NASH).
    


Intervention name(s): ZSP1601; ZSP1601 Placebo
Intervention type(s): Drug; Drug
Intervention description(s): ZSP1601 tablets be taken orally for 28 days.; Subjects will receive matching placebo of ZSP1601
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Discomfort Score Identifies Painfulness During Unsedated Colonoscopy
Condition: Risk Factors Associated With Painful Colonoscopy
Study type: Observational

Summary: 
      Some patients felt no pain or only mild discomfort with the unsedated colonoscopy. However,
      unsedated colonoscopy was thought to be an option for some but not for all. If we could able
      to identify which patients at high risk for painful colonoscopy in preoperational stage,
      targeted administration of sedatives or special techniques to these patients would be an
      attractive option.
    

Detailed description: 
      Here we prospectively collected the data during colonoscopy and investigated the possible
      risk factors associated with painful colonoscopy by using a step-wise multivariate regression
      model. Furthermore we developed a novel point score to predict whether the patients at high
      risk for painful colonoscopy and targeted offer an appropriate method of colonoscopy or with
      the aid of special techniques to help the completion of procedure.
    

Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All patients were prescribed polyethylene glycol electrolyte for bowel preparation
        according to the preference of physicians. They were asked to drink the first 2L of
        PEG4000e at19:00-20:00 PM on the night before colonoscopy within 2 hours. Then, on the day
        of the examination, patients were asked to take the remaining 2L 5 hours before the
        procedure. Patients were encouraged to drink more clear liquids after purgatives for
        adequate hydration before colonoscopy. In addition, patients were instructed to have a
        regular meal for lunch and only liquid diets for dinner the day before the operation.
Misoprostol for Treatment of Postpartum Hemorrhage at Community-level Births in Egypt
Condition: Postpartum Hemorrhage
MeSH terms: Postpartum Hemorrhage; Hemorrhage
Study type: Interventional

Summary: 
      This randomized controlled community-based trial will assess the effectiveness of
      administration of 800 mcg sublingual misoprostol with standard of care vs. placebo with
      standard of care for postpartum hemorrhage treatment at the community level, primarily home
      births attended by primary health care unit (PHU) staff in Etay El Barood and Kafr El Dawar
      districts (El Beheira governorate), Egypt. Standard of care per national guidelines in this
      setting is referral to a higher level health facility.
    

Detailed description: 
      Hospital-based clinical trials have demonstrated misoprostol to be a safe and effective
      treatment option for postpartum hemorrhage (PPH). Additional research is needed to
      demonstrate how these findings translate into program effectiveness at lower levels of the
      health care system, including community home births, where access to skilled providers and
      treatment options are limited and misoprostol could potentially have the greatest impact on
      maternal health outcomes. This randomized controlled community treatment trial will assess
      the effectiveness of misoprostol with standard of care (i.e., referral to higher level care)
      vs. placebo with standard of care for PPH treatment at the community level, primarily home
      births attended by primary health care unit staff in Etay El Barood and Kafr El Dawar
      districts (El Beheira governorate), Egypt. This research will help guide decisions on how to
      introduce misoprostol into PPH care programs in different contexts such as primary care
      settings, including community-based home births.
    

Intervention name(s): Misoprostol + referral; Placebo + referral
Intervention type(s): Other; Other
Intervention description(s): 800 mcg of sublingual misoprostol (four tablets of 200 mcg misoprostol) + standard of care (referral to higher level care); Placebo (4 tablets resembling misoprostol) + standard of care (referral to higher level care)
Intervention MeSH terms: Misoprostol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: postpartum hemorrhage; treatment; misoprostol; home births
Safety and Efficacy of Squaric Acid Dibutyl Ester for the Treatment of Herpes Labialis
Condition: Herpes Labialis
MeSH terms: Herpes Simplex; Herpes Labialis
Study type: Interventional
Phase: Phase 1

Summary: 
      Subjects with a history of recurrent herpes labialis will be sensitized with either 2% SADBE
      or placebo. Following this, subjects sensitized with 2% SADBE will received.2% sqauric acid
      or.5% squaric acid on their cold sore within 72 hours of a recurrence. Subjects sensitized
      with placebo solution will receive placebo solution on their cold sore within 72 hours of a
      recurrence. Subjects will be followed for up to 6 mos after application of study medication.
    


Intervention name(s): Squaric Acid solution; Placebo solution
Intervention type(s): Drug; Drug
Other intervention name(s): Squaric Acid Dibutyl Ester solution; SADBE
Intervention MeSH terms: Pharmaceutical Solutions; Squaric acid dibutyl ester
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Biomagnetic Signals of Intestinal Ischemia
Condition: Ischemia
MeSH terms: Ischemia
Study type: Observational

Summary: 
      The lack of blood flow to the small intestine causes mesenteric ischemia. Using a
      Superconducting QUantum Interference Device (SQUID) which measures the magnetic field of the
      small intestine, we are hoping to identify abnormalities without surgical intervention.
    

Detailed description: 
      The electrical activity of the small intestine may contain important information that will
      help us diagnose gastrointestinal diseases. The major impediment to reducing mortality of
      mesenteric ischemia is the lack of a noninvasive diagnostic test that identifies the syndrome
      before extensive necrosis occurs. Mesenteric ischemia is caused by the lack of blood flow to
      the intestine. The Superconducting QUantum Interference Device (SQUID) measures the magnetic
      field of the intestinal smooth muscle. By comparing normal smooth muscle and that of patients
      with mesenteric ischemia, we hope to identify abnormal disease states without surgery.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Primary Care Clinic
      
Keywords: Blood Supply; Mesentery
Comparison of Technics for Determination of Epstein-Barr Virus Serological Diagnosis
Condition: EBV
MeSH terms: Epstein-Barr Virus Infections
Study type: Observational

Summary: 
      This study compared the performance of three automated immunoassays, Architect (Abbott),
      Immulite (Siemens) and Liaison (Diasorin), for Epstein-Barr virus (EBV) serology. Ninety-one
      serum samples collected in Amiens University Hospital were analyzed for the presence of Viral
      Capsid Antigen (VCA) IgG and IgM and Epstein-Barr Nuclear Antigen (EBNA) IgG. The agreement
      between the three assays was calculated for each marker individually and for determination of
      the EBV profile, based on interpretation of the combination of these three EBV markers.
    

Detailed description: 
      This retrospective study was conducted on 91 samples collected between 2014 and 2015 for
      which EBV diagnosis was requested. The serological diagnosis of EBV infection was performed
      in the Amiens University Hospital virology laboratory (France). The median age of patients
      was 34 years (mean: 38 years, range: 3-82 year) with a sex ratio of 50%. Sixteen of the 91
      samples concerned children (<15 years).

      This study compared the performance of three automated immunoassays, Architect (Abbott),
      Immulite (Siemens) and Liaison (Diasorin), for Epstein-Barr virus (EBV) serology. Ninety-one
      serum samples collected in Amiens University Hospital were analyzed for the presence of Viral
      Capsid Antigen (VCA) IgG and IgM and Epstein-Barr Nuclear Antigen (EBNA) IgG. The agreement
      between the three assays was calculated for each marker individually and for determination of
      the EBV profile, based on interpretation of the combination of these three EBV markers.
    

Intervention name(s): Serological giagnosis
Intervention type(s): Other
Intervention description(s): The serological diagnosis of EBV infection was performed in the Amiens University Hospital virology laboratory (France). 91 routinely collected samples were analyzed by Immulite, Architect, and Liaison Blood samples were centrifuged for 15 min at 2500g at room temperature. Sera were aliquoted and first analyzed by Immulite. All samples were tested for EBV VCA IgG, EBV VCA IgM and EBV EBNA IgG in order to determine infection status (primary EBV infection, past infection, absence of infection and indeterminate status).
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        91 samples collected between 2014 and 2015 for which EBV diagnosis was requested. The
        serological diagnosis of EBV infection was performed in the Amiens University Hospital
        virology laboratory (France). The median age of patients was 34 years (mean: 38 years,
        range: 3-82 year) with a sex ratio of 50%. Sixteen of the 91 samples concerned children
        (<15 years)
      
Keywords: Epstein-barr virus; infectious mononucleosis
Effects of CPAP Level on Respiratory Mechanics and Central Drive in Patients With COPD
Condition: Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional

Summary: 
      Chronic Obstructive Pulmonary Disease (COPD) is a common respiratory disease characterized by
      airflow limitation that is progressive and not fully reversible. Expiratory flow limitation
      (EFL) is the main mechanism leading to dynamic pulmonary hyperinflation (DPH) and intrinsic
      positive end-expiratory pressure (PEEPi). DPH and PEEPi lead to increased inspiratory muscle
      efforts and impaired central drive mechanical and ventilation coupling, which is an important
      mechanism of dyspnea. Appropriate setting of extrinsic PEEP (PEEPe) can decrease inspiratory
      efforts and work of breathing, improve patient-ventilator synchrony in severe COPD patients
      with PEEPi and treated with mechanical ventilation. Nevertheless, the effects of CPAP/PEEPe
      level on respiratory mechanics, especially on central drive mechanical and ventilation
      coupling, still need further investigations.

      In the present study, about 40 patients with COPD will be recruited as research subjects. And
      the investigators aim to observe the changes in respiratory mechanics, central drive
      mechanics, central drive mechanical and ventilation coupling at different levels of CPAP.
      Contrast analysis will be conducted to evaluate the effects of CPAP level on respiratory
      mechanics and central drive during DPH, which may provide a reasonable basis for the clinical
      application of CPAP to COPD patients and the exploration of a new reasonable CPAP setting
      method.
    

Detailed description: 
      Patients with COPD are divided into two groups: moderate group and severe group, both of
      which are intervented by CPAP level. The static pressure volume curves of the lung and chest
      wall (Campbell diagram) were established with slow deep respiratory manoeuvre. Before using
      CPAP level, we will measure the relevant parameters of lung volume, respiratory flow,
      diaphragm electromyogram, central drive mechanical and ventilation coupling. Then incremental
      CPAP level will be applied to investigate the effects of CPAP level on the above mentioned
      respiratory mechanics parameters.
    

Intervention name(s): CPAP level
Intervention type(s): Procedure
Intervention description(s): CPAP level ranges between 4 and 12 cm water column (cmH2O), each pressure increment for 1 cmH2O.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: COPD; CPAP; Central Drive