bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy of an Oral, Killed Enterotoxigenic Escherichia Coli Vaccine in Prevention of Diarrhea in Egyptian Infants and Young Children
Condition: Diarrhea
MeSH terms: Escherichia coli Infections; Diarrhea
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a randomized, double-blind, placebo-controlled clinical trial performed in Egyptian
      children 6-18 months of age. The primary aim of the study is to determine the protective
      efficacy of an oral, inactivated whole-cell enterotoxigenic Escherichia coli (ETEC) vaccine
      against diarrhea associated with excretion of ETEC that express a vaccine-shared antigen over
      a one year period of follow-up by active surveillance. The vaccine consists of a mixture of
      five formalin-killed ETEC bacteria expressing prevalent ETEC colonization factors and
      recombinant cholera toxin B-subunit (killed ETEC/rCTB vaccine). The placebo preparation is
      heat-killed Escherichia coli K-12 bacteria.
    


Intervention name(s): ETEC/rCTB vaccine; Placebo
Intervention type(s): Biological; Other
Intervention description(s): Cocktail of five whole-cell, formalin-inactivated ETEC strains (total of 10^11 formalin-killed bacteria per dose) plus recombinant cholera toxin B-subunit (rCTB) (1 mg); Heat-killed, nonpathogenic E. coli K-12 bacteria (total of 10^11 heat-killed bacteria per dose)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Olanzapine Pamoate Depot Versus Oral Olanzapine on Treatment Outcomes in Outpatients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 3

Summary: 
      To compare the health outcome of patients with schizophrenia, who are at risk for relapse,
      when treated with a long acting injection form of olanzapine versus treatment with oral
      olanzapine.
    


Intervention name(s): olanzapine; olanzapine pamoate depot
Intervention type(s): Drug; Drug
Intervention description(s): 10 milligrams (mg), oral tablets, once daily for 4 weeks followed by 5-20 mg flexible dosing, oral tablets, once daily, for 100 weeks, for a total treatment duration of 104 weeks.; 405 milligrams (mg), intramuscular injection, followed 4 weeks later by 150-405 mg flexible dosing, intramuscular injection, every 4 weeks thereafter for 96 weeks, for a total treatment duration of 104 weeks.
Other intervention name(s): LY170053; Zyprexa
Intervention MeSH terms: Olanzapine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Early Postoperative Prevention and Treatment of Median Sternotomy Scars With Botulinum Toxin Type A Injection
Condition: Scar
MeSH terms: Cicatrix
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Linear hypertrophic scar is a common surgical problem that can be difficult to manage,
      especially for the median sternotomy scar. Despite high demand for the early intervention to
      prevent and treat surgical scars, there is yet no universal consensus on satisfactory
      treatment. Botulinum toxin type A is a neurotoxin that has been widely and safely used in
      medicine for more than 30 years. It induces chemodenervation through acting on the
      presynaptic neuron to prevent release of acetylcholine, which leads to functional denervation
      of striated muscle for about 6 months after injection. The aim of this randomized controlled
      trial is to evaluate the efficacy of Botulinum toxin type A as a prophylactic treatment in
      the early postoperative of median sternotomy for the purpose of preventing excess scar
      formation.
    

Detailed description: 
      The goal of this study is to conduct a randomized controlled trial about using Botulinum
      toxin type A ( BTA) to prevent hypertrophic scar in median sternotomy wound. The entire
      median sternotomy wound was divided into the upper half and the lower half. Both halves of
      the wound were randomized to receive treatment with either BTA or 0.9% normal saline. The
      patient and the surgeon will be blinded to the treatment arm. The primary end point was the
      evaluation of upper and lower half scar using the Vancouver Scar Scale (VSS). At 6 months
      follow-up, two blinded dermatologists examined the patients and took photographs of the scar
      in the outpatient clinic of XiJing Hospital. Scars were assessed using the VSS and assigned
      the mean score of the two observers. At 6-month follow-up, ultrasonography to measure the
      scar width will be performed. At the same time, patients were asked to evaluate their overall
      satisfaction, using a four-point grading scale for each half the scar(1= very satisfied, 2=
      satisfied,3= slightly satisfied, 4= unsatisfied ).Paired t-test was used to compare the VSS
      scores, scar width and the overall satisfaction between the BTA-treated group and normal
      saline group.
    

Intervention name(s): Botulinum toxin type A; normal saline
Intervention type(s): Drug; Drug
Intervention description(s): 50 units of botulinum toxin diluted in 1 ml of normal saline will be administered. 0.1mlof BTA will be injected with a 30G needle.; 0.1mlof normal saline will be injected with a 30G needle.
Other intervention name(s): Botox; Botulinum Toxin; NaCl 0.9%
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Botulinum toxin type A, scar
Effect of Folic Acid Supplementation on Plasma Homocysteine Level in Obese Children
Condition: Hyperhomocysteinemia; Obesity
MeSH terms: Hyperhomocysteinemia
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the present study was to determine whether folic acid supplementation could
      reduce plasma homocysteine in obese children and to determine the association between dietary
      folate, serum folate and homocysteine level through the randomized double blinded placebo
      controlled trial.
    

Detailed description: 
      Atherosclerosis is common & remains a significant clinical problem because of leading to
      myocardial infarction, stroke and cardiovascular death. Many studies founded
      hyperhomocysteinemia is an independent risk factor for those cardiovascular diseases which
      take responsible for about 10% of total cardiovascular disease risk. Reduction of elevated
      plasma homocysteine may prevent up to 25% of cardiovascular events. One of modifiable cause
      of hyperhomocysteinemia is prevention of vitamin deficiency, especially folate deficiency.

      Obese Thai children are probable risk for folate deficiency due to low dietary folate intake
      and low serum folate level from unbalanced diet (low vegetables intake & high fat diet) and
      high prevalence of thalassemia. Moreover obese children are also at risk of atherosclerosis.
      However, no data have been reported about effect of folic acid supplementation on
      homocysteine level in these patients.
    

Intervention name(s): Folic Acid; placebo
Intervention type(s): Drug; Drug
Intervention description(s): yellow tablet contained 5mg of folic acid, manufactured from the Government Pharmaceutical Organization, Ministry of Public Health, Thailand; sugar tablet manufactured to mimic folic acid tablet
Intervention MeSH terms: Folic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Folic acid; Folate; Homocysteine; Obese; Children
Preconditioning of One-lung Ventilation
Condition: One Lung Ventilation
Study type: Interventional

Summary: 
      To observe the effect of one-lung ventilation (OLV) preconditioning on perioperative
      oxygenation during thoracic surgery.
    

Detailed description: 
      For lung isolation and better surgical view, one-lung ventilation(OLV) is essential for
      thoracic surgery. However, OLV may cause serious pulmonary complications due to
      intraoperative hypoxia.

      Animal studies showed a positive effect of OLV preconditioning (Intermittent OLV before
      surgical intervention) on perioperative pulmonary oxygenation.

      Thus, we designed a study to observe the effect of OLV preconditioning on perioperative
      oxygenation during thoracic surgery
    

Intervention name(s): One-lung ventilation
Intervention type(s): Other
Intervention description(s): The patient undergoing thoracic surgery is intubated with double lumen tube after induction of general anesthesia with propofol and remifentanil.
In the intervention group, 5 cycles of one-lung ventilation preconditioning (2-min of one-lung ventilation and 2-min of two-lung ventilation for 1 cycle) is performed before surgical incision. One-lung ventilation is done at dependent lung with FiO2 100% and tidal volume 6 ml kg-1. Two-lung ventilation is done with FiO2 50%, tidal volume 8 ml kg-1.
Other intervention name(s): Preconditioning
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Prevalence of COVID-19 (Coronavirus Disease 19) in Pregnant Women on Labor in a Public Hospital in Chile (COroNavirus diSease Covid-19 pandEmic iN ChilE)
Condition: Pregnancy; Covid19; Labor (Obstetrics)--Complications; Demography
MeSH terms: COVID-19
Study type: Observational

Summary: 
      This study aim is to assess the prevalence of SARS-COV-2 in unselected pregnant women on
      labour (or a predictable delivery during next 24 hours), their outcome and sociodemographic
      conditions.
    

Detailed description: 
      This is a cross sectional study conducted in Hospital San Juan de Dios, Santiago of Chile.
      This Hospital attends nearly 4500 births every year. When the COVID-19 pandemia came to
      Chile, there was no possibility to assess the seroconversion for SARS-Cov2. Currently, it
      remains unclear the seroprevalence of SARS-Cov-2 in pregnant near to delivery in our country,
      also its correlation with clinical, perinatal outcomes and sociodemographic characteristics.
      The project will evaluate these features, collecting nasopharyngeal swab serology in a
      systematic manner in unselected pregnant women on labor (or a predictable delivery during
      next 24 hours). Maternal information including clinical data, obstetric history,
      comorbidities and sociodemographic characteristics acquired from medical records will be
      correlated to the seroconversion.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Pregnant women on labor or preterm labor or who will require interruption of their
        preg-nancy during the next 24 hours in the Hospital San Juan de Dios in Santiago de Chile
        between 15 April 2020 and 15 July 2020.
      
Keywords: Pregnancy; Labor; COVID-19; SARS-Cov2; sociodemographic
A Canadian Study to Evaluate Early Use of Adalimumab After Methotrexate Failure in Early Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 4

Summary: 
      A Canadian study to evaluate early use of adalimumab after methotrexate failure in early
      rheumatoid arthritis. The study hypothesis will verify if adalimumab effectively reduces
      joint damage in more participants when introduced earlier than in current practice.
    


Intervention name(s): adalimumab; Methotrexate
Intervention type(s): Biological; Drug
Intervention description(s): Study drug will be provided to participants in Early Adalimumab arm as a sterile, preservative-free solution for subcutaneous injection, contained in a pre-filled syringe housed in a pen device (pre-filled pen). 40 mg of adalimumab will be administered subcutaneously at Baseline and then every other week for 24 months. Adalimumab may be initiated in participants in standard of care (SOC) arm after a minimum of 6 months of treatment recommended by their study doctor.; Participants in both arms will receive a methotrexate regimen based on local guidelines and their study doctor's judgment.
Other intervention name(s): ABT-D2E7; Humira; Trexall; Rheumatrex
Intervention MeSH terms: Adalimumab; Methotrexate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Rheumatoid Arthritis; Anti-Inflammatory; Biological Therapy; adalimumab; Disease-Modifying Antirheumatic Drugs; Antirheumatic Agents; Agents
Low-dose CT-based Method for Detection of Subclinical Anthracycline-induced Cardiotoxicity
Condition: Neoplasms
MeSH terms: Cardiotoxicity
Study type: Interventional

Summary: 
      Prospective single arm study to evaluate a low-dose CT-based protocol for early detection of
      myocardial dysfunction in 50 cancer patients undergoing anthracycline-based chemotherapy.
    


Intervention name(s): low dose CT
Intervention type(s): Diagnostic Test
Intervention description(s): CT-based protocol for detection of anthracycline-induced myocardial dysfunction at early stages
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Study of SY-201 Ophthalmic Solution in Subjects With Dry Eye Disease
Condition: Dry Eye Disease
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Eye Diseases
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a phase 2, multi-center, double-masked, randomized, vehicle-controlled,
      dose-response, parallel-group study designed to evaluate the safety and tolerability and
      ocular efficacy of SY-201 Ophthalmic Solution versus vehicle over a 60-day treatment period
      in subjects with dry eye disease (DED).
    


Intervention name(s): SY-201 Ophthalmic Solution 2.0%; SY-201 Ophthalmic Solution 1.0%; SY-201 Ophthalmic Solution 0.5%; SY-201 Ophthalmic Solution Vehicle
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): SY-201 Ophthalmic Solution 2.0%; SY-201 Ophthalmic Solution 1.0%; SY-201 Ophthalmic Solution 0.5%; SY-201 Ophthalmic Solution Vehicle
Intervention MeSH terms: Pharmaceutical Solutions; Ophthalmic Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double-masked, parallel, randomized
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Effects of a Sub-maximal Exercise Program on Adolescents Who Sustained a Concussion
Condition: Concussion, Mild; Concussion, Brain; Concussion, Severe; Exertion; Excess
MeSH terms: Brain Concussion
Study type: Interventional

Summary: 
      Patients who sustain a concussion will undergo a sub-maximal exercise protocol throughout
      their recovery. Cerebrovascular function, heart rate, and symptom severity, and exercise
      volume will be monitored throughout.
    

Detailed description: 
      There has been recent change to the management of concussion, including the addition of
      exercise while a patient may still be experiencing symptoms. Some patients will be given a
      dose-dependent exercise prescription based on their own sub-maximal output. They will
      aerobically exercise at this given threshold for 8 weeks, while heart rate and symptom
      duration is tracked. Some patients will only follow physician prescribed exercise, while
      undergoing the same heart rate and symptom monitoring for 8 weeks.
    

Intervention name(s): Sub-maximal exercise
Intervention type(s): Other
Intervention description(s): Subjects will participate in aerobic exercise 5 days a week. This includes walking, biking, jogging and running. While participating in these activities, they will be wearing their Polar Wrist Unit and Heart Rate Monitor to help subjects track their exercise intensity. They will exercise for 20 minutes 5times a week at 60% of their maximum heart rate or 80% of their symptom limited heart rate.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients will be randomly assigned to either the exercise intervention group or the usual care group.
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Efficacy on Phase III Study on 300 IR SLIT to Patients Suffering From Grass Pollen Rhinoconjunctivitis
Condition: Primary Disease
MeSH terms: Conjunctivitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of sublingual tablets of
      grass pollen allergen extract when initiated 2 months before the grass pollen season compared
      with placebo for reduction of rhinoconjunctivitis symptoms and rescue medication usage.
    

Detailed description: 
      To assess the efficacy of sublingual tablets of grass pollen allergen extract when initiated
      2 months before the grass pollen season on:

      - The Average Adjusted Symptom Score (AASS).

      To document the safety of the treatment.
    

Intervention name(s): 300 IR; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 300 IR grass pollen allergen extract tablet starting 2 months before the grass pollen season and during the grass pollen season; Placebo sublingual tablet starting 2 months before the grass pollen season and during the grass pollen season
Other intervention name(s): Sublingual immunotherapy tablet; Sublingual placebo tablet
Intervention MeSH terms: Immunomodulating Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: allergic rhinoconjunctivitis
Single Dose Escalation Study of PF-05190457 in Healthy Volunteers
Condition: Diabetes Mellitus, Type II
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      PF-05190457 is a novel compound proposed for the treatment of Type 2 diabetes mellitus. The
      purpose of the study is to evaluate the safety and tolerability of PF-05190457 after
      administration of a single dose to healthy volunteers and to evaluate the plasma drug
      concentrations after single dose in healthy volunteers.
    


Intervention name(s): PF-05190457; PF-05190457; PF-05190457; PF-05190457; PF-05190457; PF-05190457; PF-05190457; PF-05190457; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Single Dose 2 mg; Single Dose 10 mg; Single Dose 30 mg; Single Dose 100 mg; Single Dose 300 mg; Single Dose 600 mg; Single Dose - to be determined with food; Single Dose - to be determined; Single Dose Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effect of Yoga in Reducing Chemotherapy Induced Nausea and Vomiting
Condition: Breast Cancer; Malignant Female Reproductive System Neoplasm; Lymphomas; Chemotherapy-induced Nausea and Vomiting
MeSH terms: Genital Neoplasms, Female; Nausea; Vomiting
Study type: Interventional
Phase: Phase 2

Summary: 
      -  This randomized controlled three arm study compares the effects of a yoga intervention
           with jacobsons progressive muscle relaxation training and only standard of care in
           chemotherapy naive cancer patients.

        -  This study will also assess the neurophysiological correlates of nausea and vomiting and
           assess if effects of intervention on nausea and vomiting outcomes are mediated by
           changes in gastric motility (electrogastrogram) or stress arousal (cardiac autonomic
           function and sympathetic skin response) or self reported anxiety.
    


Intervention name(s): yoga; Jacobsons PMRT group
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Postures,relaxation techniques; jacobsons Progressive muscle relaxation training involving 16 muscle groups
Other intervention name(s): PMRT
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: yoga; chemotherapy; nausea; vomiting
Cognitive Behavioral Therapy and the Nicotine Transdermal Patch for Cannabis Dependence and Nicotine Dependence
Condition: Cannabis Dependence; Nicotine Dependence
MeSH terms: Marijuana Abuse; Tobacco Use Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      The investigators are conducting a Stage 1 pilot feasibility study at McLean Hospital to
      develop and refine a Cognitive Behavioral Therapy (CBT) intervention. The investigators aim
      to develop a feasible 10-week integrated CBT intervention for the treatment of concurrent
      marijuana dependence and nicotine dependence. The investigators hypothesize that the CBT
      intervention, in conjunction with Nicotine Replacement Therapy (NRT) in the form of a
      transdermal nicotine patch, will reduce the use of marijuana and nicotine.
    

Detailed description: 
      The investigators will conduct a Stage 1 pilot feasibility study at McLean Hospital to
      develop and refine a Cognitive Behavioral Therapy (CBT) intervention. Twelve subjects (50%
      female, ages 18-65) who meet Diagnostic and Statistical Manual of Mental Disorders 4th
      edition (DSM-IV) criteria for both marijuana and nicotine dependence and seek treatment to
      stop using both marijuana and tobacco will receive individual CBT aimed at treating both
      disorders, as well as Nicotine Replacement Therapy (NRT) in the form of a transdermal
      nicotine patch. Subjects will start with a 21-mg nicotine patch for 6 weeks, followed by a
      taper to a 14-mg nicotine patch for 2 weeks and, finally, a 7-mg nicotine patch for 2 weeks.
      Others will start with a 14-mg patch for 8 weeks followed by a 7-mg patch for 2 weeks. All
      participants will receive 10 weeks of 1-hour weekly CBT with an experienced clinician.
      Follow-up visits, scheduled at 4, 6, 8, and 10 weeks, will evaluate of the durability of
      treatment effects on drug use and psychosocial outcomes.
    

Intervention name(s): Cognitive Behavioral Therapy; Nicotine Replacement Therapy
Intervention type(s): Behavioral; Drug
Intervention description(s): individual CBT once weekly, 50 minutes, for 10 weeks; 21 mg patch for 6 weeks, 14 mg patch for 2 weeks, then 7 mg patch for 2 weeks
14 m g patch for 8 weeks, then 7 mg patch for 2 weeks
Other intervention name(s): Nicotine Transdermal Patch
Intervention MeSH terms: Nicotine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cognitive behavioral therapy; nicotine dependence; cannabis dependence; smoking cessation; nicotine replacement therapy