bioihbjkbjnl/mcl2 huggingface dataset:
Saliva Profiles in Children With Congenital Heart Disease
Condition: Cardiac Disease; Dental Caries
MeSH terms: Dental Caries; Heart Diseases; Heart Defects, Congenital
Study type: Interventional

Summary: 
      The purpose of this study was to evaluate whether there are relationships between the
      salivary oxidative stress status of children with CHD directly dental caries including
      gender, age, salivary flow rate, salivary pH, salivary buffering capacity and drug intake
      such as angiotensin-converting enzyme (ACE) inhibitors. If such relationships exist, they
      might be employed to patient caries -prevention treatment.
    

Detailed description: 
      Using heart failure medications may cause low salivary pH and buffering capacity.As improved
      oral health is a priority for cardiac patients, it is necessary that they attend dental
      clinics for regular follow up.

      This cross sectional study was carried out with 42 CHD and 42 healthy children who applied to
      Istanbul University, Faculty of Dentistry, Department of Pedodontics. Gender, age, general
      health and medications, and caries scores (dfs/DMFS) were recorded. Unstimulated saliva was
      collected from the participants and were assessed for the salivary secretion rate, salivary
      buffering capacity, pH, protein levels, superoxide dismutase (SOD), ferric reducing
      antioxidant power (FRAP), the thiobarbituric acid reactive substances (TBARS), protein
      carbonyl, protein thiols, total sialic acid.
    

Intervention name(s): saliva
Intervention type(s): Other
Intervention description(s): salivary secretion rate, salivary buffering capacity, pH, protein levels, superoxide dismutase (SOD), ferric reducing antioxidant power (FRAP), the thiobarbituric acid reactive substances (TBARS), protein carbonyl, protein thiols, total sialic acid.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: cross sectional study was carried out with 42 CHD and 42 healthy children
Masking: Single (Participant)
Primary purpose: Diagnostic
Keywords: saliva composition; antioxidant activity; caries risk factors; congenital cardiac disease
Safety and Efficacy of Multiple Doses of BT061 in Patients With Moderate to Severe Chronic Plaque Psoriasis
Condition: Psoriasis Vulgaris
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 2

Summary: 
      This Phase II clinical study is to test safety and efficacy of BT061 against psoriasis given
      as repeated doses.
    

Detailed description: 
      Patients are enrolled into escalating dose levels. Improvement of PASI, physician's global
      assessment and itching score is evaluated after administration of BT061 or placebo. Safety
      data are assessed by an independent data and safety monitoring board (DSMB).
    

Intervention name(s): BT061; placebo treatment
Intervention type(s): Drug; Drug
Intervention description(s): administration of BT061 either intravenous or subcutaneous; administration of the end formulation buffer of BT061 without active ingredient, either subcutaneous or intravenous
Other intervention name(s): SC or IV administration of BT061 or placebo; SC or IV administration of BT061 or placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: chronic plaque psoriasis; psoriasis vulgaris; autoimmune disease
Efficacy of Proprietary Cherry Juice Blend in Osteoarthritis of the Knee
Condition: Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary purpose of this research study is to test the ability of a proprietary cherry
      juice blend to be helpful in the treatment of osteoarthritis (OA) of the knee.
    

Detailed description: 
      The primary objective is to determine if the proprietary tart cherry juice blend improves the
      pain and function in persons with knee osteoarthritis. A secondary objective is to ascertain
      if the blend lowers serum uric acid.

      This is a prospective double blind, placebo controlled cross-over study.

      The study will be performed in the Philadelphia VA Medical Center 1 South Rheumatology Clinic
      with patients meeting ACR criteria for Kellgren grade 2-3 knee osteoarthritis and 4-9 pain
      severity on a VAS. Fifty patients will be studied with each having 5 visits. Subjects will
      take either the proprietary cherry blend or placebo for 6 weeks and then switch. WOMAC pain
      and function will be the primary outcome with acetaminophen use, walking time and serum uric
      acid as secondary outcomes.
    

Intervention name(s): proprietary cherry juice blend (food); control juice (kool aid blend)
Intervention type(s): Other; Other
Intervention description(s): 2 bottles per day for 6 weeks, 1 in the morning and 1 in the evening; 2 bottles per day for 6 weeks, 1 in the morning and 1 in the evening
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: osteoarthritis; gout; pain; uric acid; tart cherry; alternative medicine; knees
Comparing the Efficacy of WeChat-based Patient Education and Conventional Patient Education in the Management of Helicobacter Pylori Eradication
Condition: Helicobacter Pylori Infection Helicobacter Pylori Eradication Patient Education
Study type: Observational

Summary: 
      we conducted a retrospective study to compare the efficacy of WeChat-based patient education
      and conventional patient education in the management of Helicobacter pylori eradication.
    

Detailed description: 
      This is a single-institute retrospective study comparing the efficacy of WeChat-based patient
      education and conventional patient education in the management of Helicobacter pylori
      eradication. We identified all patients aged between 18-75 years old and had been prescribed
      a 14-day course of bismuth-contained quadruple therapy for H. pylori infection in our
      outpatient clinics between 1 July 2019 and 31 July 2021. H. pylori infection was confirmed by
      any two positive outcomes of rapid urease test,13C-urea breath test (UBT) and histopathology.
      Patients who had H. pylori therapy history, using other therapeutic regimens or unwilling to
      take prescribed medications were excluded. Demographic data, treatment regimens, outcomes of
      therapy, adherence to therapy and adverse event were retrieved. The main indicator is
      eradication rate, as the secondary indicators are compliance and adverse events.
    

Intervention name(s): patient education; patient education
Intervention type(s): Other; Other
Intervention description(s): patients in experimental group were asked to join a WeChat group, which was governed by experienced gastroenterologists. Relevant knowledge of H. pylori eradication was released in the group chat irregularly. Patients in WeChat group were allowed to ask questions at any time during the whole treatment process, soon afterwards, suggestions were given.; Patients in the control group received verbal education and a specifically designed printout with detailed instructions.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        patients aged between 18-75 years old and had been prescribed a 14-day course of
        bismuth-contained quadruple therapy for H. pylori infection in our outpatient clinics
        between 1 July 2019 and 31 July 2021. H. pylori infection was confirmed by any two positive
        outcomes of rapid urease test,13C-urea breath test (UBT) and histopathology. Patients who
        had H. pylori therapy history, using other therapeutic regimens or unwilling to take
        prescribed medications were excluded.
      
Keywords: helicobacter pylori eradication patient education Wechat group
Controlled Propofol Administration
Condition: HYPNOSIS
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to compare the administration of the standard anesthetic agent
      (propofol) using this automatic system with the manual administration of propofol by the
      anesthesiologist.
    


Intervention name(s): propofol
Intervention type(s): Drug
Intervention description(s): propofol administration
Intervention MeSH terms: Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hypnosis with propofol
Impact of Three Continuing Education Meetings for Community Pharmacists on Weight Management
Condition: Continuing Pharmacy Education; Obesity
Study type: Interventional

Summary: 
      This study is a three-arm randomized controlled trial to evaluate the effects of 1-day
      continuing educational meetings for community pharmacists with three distinct educational
      methods: 1) Didactic lecture 2) Didactic lecture plus case discussion in a large group 3)
      Didactic lecture plus small group education with simulated patient

      Knowledge and attitude of the participants would be measured as the study outcome in three
      periods: pre-education, post-education and 1 month after the meetings.
    

Detailed description: 
      The study is designed as an Instructor blinded-Randomized Controlled Trial.

      An educational need assessment is undergone prior to educational content preparation by
      interviewing 5 community pharmacists. After educational content preparation by instructors,
      the outcome assessment tool (knowledge, attitude questionnaire) would be designed by a
      distinct investigator. Closed and Open-ended questions are included to investigate different
      levels of Bloom's taxonomy.

      The questionnaire would be validated by specialists other than the instructors and it will
      piloted to investigate the reliability( Cronbach's Alfa > 0.7).

      Community pharmacists of Tehran,Capital city of Iran, would be invited to participate in the
      study. The participants would be randomly assigned to 3 groups by random number table. Each
      group receives the same education content with a different method:

        1. Didactic lecture

        2. Didactic lecture plus case discussion in a large group

        3. Didactic lecture plus small group education with simulated patient(SP). Interviewing
           with SP is conducted by small group facilitators with Brain Storming Technic.

      Each participant receives a compact disk which includes the educational material and he/she
      would be able to contact the instructors by phone or e-mail during the follow-up period.
      (Reinforcement Phase)
    

Intervention name(s): Didactic Lecture; Interactive Lecture; Lecture plus Small Group Education
Intervention type(s): Other; Other; Other
Intervention description(s): 2 sessions of didactic lecture with PowerPoint presentations each delivered by a special lecturer. whole education period lasts 3 hours.; 2 sessions of brief interactive lectures followed by case discussion sections.; A 1.5 hours session of didactic lecture followed by a session of small group education with 3 simulated patients.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Health Services Research
Behavior Intervention for Weight Loss for Type 2 Diabetes Mellitus Adults With Obesity Problem (BMI of ≥23kg/m2)
Condition: Obesity; Diabetes Mellitus, Type 2; Behavior
MeSH terms: Diabetes Mellitus; Obesity; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      This quasi-experimental study aims to determine the effectiveness of a health intervention
      (Chance2Act) on behaviour change to act for weight loss among overweight/obese type 2
      diabetes adults.

      The main question it aims to answer is:

      - Is the new health intervention (Chance2Act) effective in changing overweight/obese type 2
      diabetes adults from not being ready to act, to take action to lose weight?
    


Intervention name(s): Chance2Act
Intervention type(s): Behavioral
Intervention description(s): A Health education package that has been developed based on Transtheoretical Model to encourage behaviour change for weight loss among overweight/obese type 2 diabetes adults.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Managing Outpatient Hysteroscopy-associated Pain
Condition: Pain; Hysteroscopic Surgery
Study type: Interventional

Summary: 
      Hysteroscopy is a reference diagnostic and therapeutic procedure in intrauterine pathologies,
      increasingly performed without general anesthesia. Pain is the most common reason for
      discontinuation of outpatient hysteroscopy (OH). There is no consensus on pain alleviation
      during OH. The aim was to compare the effectiveness of pain relief options during OH.
    

Detailed description: 
      A prospective randomized trial (consent no.1072.6120.228.2021) includes women subjected to OH
      due to focal uterine lesion, abnormal uterine bleeding, or infertility. Women are randomly
      assigned to 3 arms - A: NSAID (ketoprofen 100 mg intravenously), B: A+infiltration anesthesia
      (20 ml 1% lidocaine), C: A+paracervical block (20 ml 1% lidocaine). Karl Storz 5.0 mm
      Bettocchi® operative sheath with 2.9 mm 30 degree telescope and 5 Fr working channel was
      used. Intensity of pain in numeric rating scale (NRS), intensity of cervical bleeding,
      frequency of vaso-vagal reaction, and frequency of abandoning/ limiting the procedure were
      compared.
    

Intervention name(s): ketoprofen for pain relief in office hysteroscopy; ketoprofen plus infiltration anesthesia with lidocaine for pain relief in office hysteroscopy; ketoprofen plus paracervical block anesthesia with lidocaine for pain relief in office hysteroscopy
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): ketoprofen ketoprofen 100 mg intravenously 30 minutes pre-procedure for pain relief in office hysteroscopy; ketoprofen ketoprofen 100 mg intravenously 30 minutes pre-procedure for pain relief in office hysteroscopy plus 20 ml 1% lidocaine in intracervical administration at the start of the procedure; ketoprofen ketoprofen 100 mg intravenously 30 minutes pre-procedure for pain relief in office hysteroscopy plus 20 ml 1% lidocaine in paracervical block at the start of the procedure
Intervention MeSH terms: Ketoprofen; Lidocaine; Anesthetics
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Women are randomly assigned to 3 arms - A: NSAID (ketoprofen 100 mg intravenously), B: A+infiltration anesthesia (20 ml 1% lidocaine), C: A+paracervical block (20 ml 1% lidocaine).
Masking: None (Open Label)
Primary purpose: Treatment
S8809-S9800-S9911TM- Biological Markers in Patients With Follicular Lymphoma Treated on Clinical Trial SWOG-8809, SWOG-9800, or SWOG-9911
Condition: Lymphoma
MeSH terms: Lymphoma; Lymphoma, Follicular
Study type: Observational

Summary: 
      RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help
      doctors identify and learn more about biomarkers related to cancer. It may also help doctors
      predict how patients respond to treatment.

      PURPOSE: This laboratory study is examining biological markers in patients with follicular
      lymphoma treated on clinical trial SWOG-8809, SWOG-9800, or SWOG-9911.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the prognostic significance of MUM-1, lymphoma-associated macrophages, and
           regulatory T cells in patients with follicular lymphoma treated on clinical trials
           SWOG-8809, SWOG-9800, or SWOG-9911 representing pre- and post-monoclonal antibody
           therapy protocols.

        -  Determine whether these factors have similar prognostic significance in patients treated
           with chemotherapy alone vs chemotherapy and monoclonal antibody therapy on these
           clinical trials.

      OUTLINE: This is a multicenter study.

      Previously collected tissue samples from patients are analyzed by immunohistochemistry, gene
      expression profiling, and quantitative analysis for MUM1 expression, lymphoma-associated
      macrophages, FOXP3-positive regulatory T cells, CD68, and CD163.

      PROJECTED ACCRUAL: A total of 318 samples will be accrued for this study.
    

Intervention name(s): microarray analysis; immunohistochemistry staining method; laboratory biomarker analysis
Intervention type(s): Genetic; Other; Other
Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients enrolled to S8809, S9800 and S9911 consenting to banking
      
Keywords: contiguous stage II grade 1 follicular lymphoma; contiguous stage II grade 2 follicular lymphoma; contiguous stage II grade 3 follicular lymphoma; noncontiguous stage II grade 1 follicular lymphoma; noncontiguous stage II grade 2 follicular lymphoma; noncontiguous stage II grade 3 follicular lymphoma; stage III grade 1 follicular lymphoma; stage III grade 2 follicular lymphoma; stage III grade 3 follicular lymphoma; stage IV grade 1 follicular lymphoma; stage IV grade 2 follicular lymphoma; stage IV grade 3 follicular lymphoma
Clinical Study to Investigate the Pharmacokinetics, Efficacy, Safety and Immunogenicity of a Recombinant FVIII in Patients With Severe Hemophilia A
Condition: Hemophilia A
MeSH terms: Hemophilia A
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a clinical study to investigate the pharmacokinetics, efficacy, safety and
      immunogenicity of human-cl rhFVIII, a newly developed human cell-line derived recombinant
      FVIII concentrate in previously treated patients with severe Hemophilia A.
    


Intervention name(s): Human-cl rhFVIII; Kogenate FS
Intervention type(s): Biological; Biological
Intervention description(s): 50 IU/kg for PK dose; 50 IU/kg for PK dose
Intervention MeSH terms: Factor VIII
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Assessment of Pharmacokinetics and Safety of M923 Administered Via Auto-injector or Prefilled Syringe, in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will assess the pharmacokinetic (PK) and safety of a single 0.8 mL (40 mg)
      subcutaneous (SC) dose of M923 administered via an auto-injector (AI) or a prefilled syringe
      (PFS) in healthy subjects.
    


Intervention name(s): M923
Intervention type(s): Biological
Intervention description(s): Recombinant human immunoglobulin G subclass 1 (IgG1) monoclonal antibody specific for human tumor necrosis factor-alpha (TNF-α)
Other intervention name(s): Adalimumab
Intervention MeSH terms: Adalimumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
12-Week Study of Plecanatide for CIC (The National CIC3 Study)
Condition: Chronic Idiopathic Constipation
MeSH terms: Constipation
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to confirm that the investigational medication, plecanatide, is
      safe and effective in treating chronic idiopathic constipation.
    

Detailed description: 
      This is a national, randomized, 12-week, double-blind, placebo-controlled, study in
      approximately 1350 adult male and female patients with CIC comparing 2 doses of plecanatide
      to placebo. The study will be conducted at approximately 180 clinical study sites in the
      United States. The primary objective of the study is to evaluate the efficacy and safety of
      3.0 and 6.0 mg of plecanatide administered once daily (QD) for 12 weeks in a population of
      patients with CIC. The study population will include only patients without other causes of
      constipation or other chronic conditions that could interfere with study assessments.
      Patients may not take laxatives (with the exception of the study-provided rescue medication,
      bisacodyl 5mg tablets), or a number of prohibited drugs that are known to cause constipation
      or diarrhea, during study participation.

      There are 6 scheduled study visits, including the screening and follow-up visits. The planned
      duration of participation in this study will be 112 days and up to 155 days, with washout and
      all visit windows considered.
    

Intervention name(s): Plecanatide; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Plecanatide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: CIC; Constipation; Chronic Constipation; Synergy; Plecanatide
DP13 - A Phase II Study in Patients With Primary Aldosteronism
Condition: Primary Aldosteronism
MeSH terms: Hyperaldosteronism
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the present phase II study is to determine whether DP13 displays the clinical
      safety and efficacy profile to support further development in patients with primary
      aldosteronism.
    

Detailed description: 
      A phase II, multi-centre, randomized, parallel group, baseline-and withdrawal-controlled
      study in 36 patients with primary aldosteronism to determine the dose-dependent efficacy,
      safety and tolerability of DP13 after a 2-week single-blind placebo run-in period followed by
      a randomized 8-week double-blind treatment period. After an additional single-blind, 2-week
      DP13 placebo withdrawal period, patients are switched to standard of care.
    

Intervention name(s): DP13
Intervention type(s): Drug
Intervention description(s): DP13 systemic administration
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment