bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy of Ultrasound Guided Rectus Sheath Block on Post Operative Quality of Recovery
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      Effective Postoperative pain management following laparotomy represents a cornerstone in the
      care of surgical patients. With the growing utilization of Enhanced recovery after surgery
      protocols (ERAS), a paradigm shift in perioperative care has resulted in reduction of both
      hospital stay and clinical complications faced by patients.

      One important component of successful implementation of ERAS protocol is optimized pain
      control. It has been shown that opioids have a considerable role in reducing bowel motility
      in addition; it hinders early mobilization and enteral feeding besides their commonly faced
      side effects such as nausea and vomiting.

      Consequently, ERAS programs encourage the usage of multimodal opioid sparing analgesia which
      includes neuraxial or regional anesthesia techniques to provide effective pain relief while
      reducing the opioid related side effects. [1]

      Regional blocks have remained popular with evidence of superior postoperative pain control
      when compared with systemic analgesics. Regional anaesthesia techniques have undergone
      considerable refinement with the advent of ultrasound guidance. Ultrasound visualization of
      anatomical structures increases both the safety and quality of regional blocks through
      optimal needle placement. Ultrasound-guided rectus sheath (RS) blocks are an emerging
      anaesthetic technique providing excellent analgesia after laparotomy. The anatomic
      characteristics of this block suggest minimal serious complications are likely, and this
      regional block is particularly useful where epidural is contraindicated
    


Intervention name(s): rectus sheath block
Intervention type(s): Procedure
Intervention description(s): blocking the nerve underneath the rectus muscle by bupivicaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Supportive Care
Incidence of Major Cardiovascular Events in Diabetic Patients With ACS Undergoing Coronary Angioplasty and Treated With Clopidogrel 150 mg Versus 75 mg
Condition: Diabetes Mellitus, Type 2; NSTEMI - Non-ST Segment Elevation MI; Coronary Angioplasty
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      Acute Coronary Syndrome (ACS) is triggered by the rupture of an atherosclerotic plaque that
      results in a platelet aggregation reaction in the coronary artery. The administration of
      antiplatelet agents starting from the acute phase of the disease has helped reduce the risk
      of ischemic relapse both during initial and long-term hospitalization.

      Management of clopidogrel following an ischemic event has been the subject of several
      treatment regimens ranging from a single continuous dose to a sequential double dose of
      between 7 and 30 days. The CURRENT-OASIS 7 therapeutic trial showed a benefit of clopidogrel
      double dose in reducing the risk of myocardial intervention (MI) and the composite outcome:
      cardiovascular mortality, MI, or stroke (CVA/TIA) at 30 days. However, the study protocol was
      interested in all ACSs, regardless of the Type 2 Diabetes Mellitus (T2DM) status in selected
      patients. Also, doubling of clopidogrel dose was maintained over 7 days after angioplasty.
      The literature describes an increased cardiovascular risk in type II diabetics in secondary
      prevention. No previous study has evaluated the effect of clopidogrel double dose given for 1
      month on the reduction of this risk in the long-term in diabetic patients.

      Thus, the objective of this study is to evaluate the efficacy and safety of clopidogrel
      double dose, given for 1 month in ACS in the diabetic patient.
    

Detailed description: 
      The study is an open label, multicentric clinical trial. Collected data are managed by the
      DACIMA Clinical Suite®, the electronic data capture platform which complies with the FDA 21
      CFR part 11 requirements (Food and Drug Administration 21 Code of Federal Regulations part
      11), the HIPAA specifications (Health Insurance Portability and Accountability Act), and the
      ICH standards (International Conference on Harmonisation).
    

Intervention name(s): Clopidogrel
Intervention type(s): Drug
Intervention description(s): COPIGREL® - clopidogrel dosed at 75 mg per tablet
Other intervention name(s): COPIGREL®
Intervention MeSH terms: Clopidogrel
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A comparative, interventional, multicenter, randomized, prospective, two-arm study with monotherapy in two different doses
Masking: None (Open Label)
Primary purpose: Treatment
EXPRESS: Examining Pagoclone for Persistent Developmental Stuttering Study
Condition: Persistent Developmental Stuttering
MeSH terms: Stuttering
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of the study is to determine the effects of pagoclone on the symptoms of
      Persistent Developmental Stuttering, using a flexible dosing titration regimen on persistent
      developmental stuttering in patients 18 to 65 years of age.
    


Intervention name(s): Pagoclone; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Persistent Developmental Stuttering
A Randomized, Parallel-Group Comparison Study of Topical Corticosteroids in Dry Eye Patients With Sjögren Syndrome
Condition: Dry Eye Syndromes; Sjögren Syndrome
MeSH terms: Sjogren's Syndrome; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Syndrome
Study type: Observational [Patient Registry]

Summary: 
      The purpose of this study is to evaluate the effectiveness of fluorometholone combined with
      sodium hyaluronate eye drops in the treatment of Sjögren syndrome.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        the people who suffered from the dry eye disease coused by the Sjögren syndrome
      
Keywords: Corticosteroids Dry Eye Sjögren syndrome inflammation treatment
Healthful Seafood Consumption for Sensitive Populations
Condition: Infant Brain Health
Study type: Interventional

Summary: 
      Fish can provide pregnant women with omega-3 fatty acids for fetal brain development but some
      fish contains high levels of mercury which is detrimental to fetal brain development. The
      hypothesis is that women who have previously consumed high mercury fish can reduce the
      mercury level in their bodies and improve their omega-3 levels in three months by eating fish
      that is high in omega-3 fatty acids and low in mercury.
    

Detailed description: 
      Exposure to methylmercury, a developmental toxicant found primarily in fish. Fish is
      nutritionally important for providing long chain omega-3 fatty acids that are important for
      perinatal health. Since maternal transfer of mercury and omega-3 fatty acids are the primary
      routes for fetal (placental transfer) or infant (maternal milk) exposure, there is a critical
      need to develop specific advice for childbearing-aged women based upon the 2004 Dietary
      Guidelines Advisory Committee's recommended intake i.e., consume 8 ounces of fish per week.
      This clinical trial investigates whether weekly consumption of selected fish species for 12
      weeks can improve plasma concentrations of the omega-3 fatty acids (eicosapentaenoic acid
      (EPA) and docosahexaenoic acid (DHA)) while reducing hair or blood mercury concentrations.
    

Intervention name(s): Feeding low mercury fish
Intervention type(s): Other
Intervention description(s): Subjects fed 6 oz of either tilapia (low omega-3 fish) or salmon (high omega-3 fish) for 3 months. Both fish are low in mercury
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Fish; mercury; omega-3 fatty acids; infant; brain development; pregnancy; nursing mother; dietary recommendations; Hair mercury; Blood mercury; Recommendations for pregnant or nursing women; Infant brain health
Predictive Value of Inflammatory Biomarkers and FEV1 for COPD
Condition: COPD; FEV1
Study type: Observational

Summary: 
      This is a multi-center, prospective, cohort study. A total of 10,000 people aged 40～75
      without lung disease will be recruited and followed for 3 years. By measure the rate of
      decline in forced expiratory volume at one second（FEV1） and baseline inflammatory biomarkers
      in exhaled breath condensate and peripheral blood, we aim to explore the predictive model for
      chronic obstructive pulmonary disease（COPD） in China.
    

Detailed description: 
      This is a multi-center, prospective, cohort study. A total of 10,000 subjects aged 40～75
      without history of lung disease will be recruited and followed for 3 years. The Department of
      Respiratory and Critical Care of Peking University First Hospital is responsible for this
      research. Other 9 units participating in the study, include the The Second Hospital of Hebei
      Medical University, Henan Provincial People's Hospital, The Second Hospital of Jilin
      University, The First Affiliated Hospital of Xi'an Jiaotong University, Shandong Provincial
      Hospital Affiliated to Shandong University,Shanxi Dayi Hospital, Tianjin Medical University
      General Hospital, The Affiliated Hospital of Inner Mongolia Medical University,The First
      Hospital of Qinhuangdao. Some questionnaire such as St George's Respiratory Questionnaire
      (SGRQ), income class, educational level, comorbidity, smoking habit and biomass smoke
      exposure history will be collected. The baseline level of Interleukin 6 (IL-6),
      high-sensitivity C-reactive Protein (hs-CRP), microRNAs-23a (miR-23a) in peripheral blood and
      pH value in exhaled breath condensate (EBC) will be measured, lung spirometry will be tested
      in the first, second and fourth years. Primary outcome is the incidence of COPD, multivariate
      regression analysis will be used to establish the predictive model for COPD in China.

      The study protocol has been approved by the Peking University First Hospital Institutional
      Review Board (IRB) (2018-31). Any protocol modifications will be submitted for the IRB review
      and approval.
    

Intervention name(s): No intervention
Intervention type(s): Other
Intervention description(s): This is a multi-center,observational, prospective, cohort study. A total of 10,000 subjects aged 40～75 without history of lung disease will be recruited and followed for 3 years. So there is no intervention in this study.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        A total of 10,000 subjects aged 40～75 without history of lung disease will be recruited and
        followed for 3 years.
      
Biospecimen description: 
      plasma，whole blood，exhaled breath condensate
    
Keywords: COPD incidence; Decline in FEV1; Inflammatory biomarkers; EBC; microRNA-23a
Effectiveness of an Interactive Consulting System to Enhance Patients' Decision-making: A Randomized Controlled Trial
Condition: Age-related Cataract
MeSH terms: Cataract
Study type: Interventional

Summary: 
      To compare the effectiveness of an interactive mobile chatbot and traditional decision aid
      booklets to enhance informed decisions made by cataract patients. The chatbot was built based
      on large language models, and could generate ChatGPT-level responses.
    

Detailed description: 
      Cataract surgery is the only way to treat age-related cataract. For patients at early or
      moderate stages, cataract surgery is an elective surgery without objective indications.
      Therefore, patients are uaually not aware whether they should receive the surgery or not. In
      clinical practice, traditional Patient Decision Aids (PDA) booklets are used to provide
      health education to patients. However, PDAs lack real-time interaction with patients, and are
      unable to answer the new questions raised. Patients still have doubts about whether they
      should receive cataract surgery or not. In this study, the investigators aim to assess the
      effectiveness of an interactive Q&A mobile application based on natural language processing
      technology to enhance informed decisions made by cataract patients.
    

Intervention name(s): Interactive Consulting System; A traditional patient decision aid brochure
Intervention type(s): Other; Other
Intervention description(s): Potential participants use the Interactive Consulting System on a mobile application with information about cataract surgery choice, and outcome data will be gathered using standardized questions in a structured interview after 2 weeks.; Potential participants receive a traditional patient decision aid brochure with information about cataract surgery choice, and outcome data will be gathered using standardized questions in a structured interview after 2 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Paracetamol Hypothermia Children
Condition: Safety Issues
MeSH terms: Hypothermia
Study type: Interventional
Phase: Phase 4

Summary: 
      Transient Acetaminophen Induced Hypothermia in Pediatrics Population Undergoing General
      Anesthesia
    


Intervention name(s): Paracetamol
Intervention type(s): Drug
Intervention description(s): Give paracetamol or placebo and compare temperature
Intervention MeSH terms: Acetaminophen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Other
Biphasic Insulin Aspart 30 in Type 2 Diabetes Failing OAD Therapy
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      This trial is conducted in the United States of America (USA). The aim of this trial is to
      compare biphasic insulin aspart 30 plus metformin in a standard injection regimen to a
      standard dosing of insulin glargine plus metformin on blood glucose control in subjects with
      type 2 diabetes who are insulin naive and failing OAD therapy.
    


Intervention name(s): biphasic insulin aspart; insulin glargine; metformin; pioglitazone
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Metformin; Insulin Glargine; Pioglitazone; Insulin Aspart; Biphasic Insulins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Efficacy of Iontophoretic Dexamethasone Phosphate Ophthalmic Solution in Non-Infectious Anterior Uveitis
Condition: Anterior Uveitis
MeSH terms: Uveitis; Uveitis, Anterior; Iridocyclitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of ocular iontophoresis with
      dexamethasone phosphate ophthalmic solution EGP-437 using the EyeGate® II Drug Delivery
      System (EGDS) compared to prednisolone acetate ophthalmic suspension (1%) in patients with
      non-infectious anterior segment uveitis.
    

Detailed description: 
      This will be a Phase 3, randomized, double-masked, parallel arm, positive-controlled
      non-inferiority study, in which up to 250 subjects (approximately 125 subjects per treatment
      arm) will be enrolled at up to 60 clinical sites. Patients with non-infectious anterior
      segment uveitis who are interested in participating in the study will be provided an informed
      consent form prior to screening. Screening/Baseline procedures which include BCVA, slit lamp
      examination, fundus exam, IOP by tonometry will be used to determine eligibility.
    

Intervention name(s): Dexamethasone Phosphate Ophthalmic Solution; Prednisolone Acetate Ophthalmic (1%)
Intervention type(s): Drug; Drug
Intervention description(s): 40 mg/mL; Prednisolone Acetate (1%)
Other intervention name(s): EGP-437; Pred Acetate (1%)
Intervention MeSH terms: Dexamethasone; Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Ophthalmic Solutions; Prednisolone hemisuccinate; Prednisolone phosphate; Dexamethasone 21-phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Iontophoresis; Ophthalmology; Non-Infectious Anterior Segment Uveitis
The Effect of Stabilization Exercises After Radiofrequency Lumbar Facet Denervation
Condition: Low Back Pain; Facet Joint Pain; Radiofrequency Denervation; Pain; Disability Physical
MeSH terms: Arthralgia; Low Back Pain
Study type: Interventional

Summary: 
      A gap of knowledge exists on the understanding of the acute effects of stabilization
      exercises on pain, disability and physical performance when applied after radiofrequency
      denervation. Therefore, the main objective of this study is to show the effects of
      stabilization exercises when started in acute period and also reduce the frequency of
      recurrence low back pain of patients with FJS after radiofrequency denervation.
    

Detailed description: 
      Lumbar facet joint syndrome has been described as a potential cause of low back pain and
      affects an estimated 4% to 8% of those low back pain patients without neurological deficits
      or radiographic evidence of lumbar spine disease. The levels of physical performance and
      functional disability of the patients with lumbar FJS are affected because of the chronicity
      of the pain.

      Radiofrequency denervation (RFD) is one of the therapautic procedures are used most commonly
      in treatment of facet joint syndrome. Numerous placebo-controlled trials have examined lumbar
      facet pain and demonstrated that RFD yields positive results in lumbar pain in properly
      selected patients. The lumbar stabilization exercise is based on the control of the local
      muscle system (multifidus, transversus abdominis, diaphragm and pelvic floor muscles)
      responsible for ensuring segmental stability of the vertebral colon in recent years.

      In the clinical trials, stabilization exercises have been shown to reduce pain, improves
      physical performance and prevent the recurrent low back pain by strengthing of muscles
      supporting the vertebral colon.

      Therefore, the main objective of this study is to show the effects of stabilization exercises
      when started in acute period and also reduce the frequency of recurrence low back pain of
      patients with FJS after radiofrequency denervation.
    

Intervention name(s): Exercise
Intervention type(s): Other
Intervention description(s): Exercises were basically performed in 3 phases in this study. In the first phase; effectively and correctly contraction of TrA and multifidus muscles and how the patients adapted to daily life activities was taught. In the second phase; was aimed that the protection of stabilization by counteracting more muscle activation, in the third phase neutral position along with the activities required high level control.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Stabilizastion (exercise group) and control group
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy of a Web-based Sexual Violence Risk Reduction Program for Female College Students
Condition: Sexual Violence
Study type: Interventional

Summary: 
      This study evaluates the efficacy of a web-based program for female college freshmen
      ("RealConsent") in reducing their risk of sexual violence victimization. Half the
      participants will receive RealConsent-F and half will receive an attention-placebo control
      ("Stress and Mood Management").
    

Detailed description: 
      Sexual assault of college women is a serious and complex public health problem: one in five
      college women report being sexually assaulted. The purpose of this study is to conduct a
      randomized controlled trial study with 750 female college students from three universities to
      test the efficacy of RealConsent, a sexual violence risk reduction program for college women,
      compared to an attention-placebo control. RealConsent is a multi-media 3-hour program based
      on social cognitive theory and alcohol myopia theory. The primary outcome will be
      self-reported sexual violence victimization and the secondary outcomes will be alcohol and
      dating protective- and risk-related behaviors and resistance strategies. The investigators
      expect that women in the treatment group will report less sexual violence victimization than
      women in the control group. Expected outcomes are demonstrated feasibility and efficacy of a
      technologically novel risk reduction program for female college students.
    

Intervention name(s): RealConsent; Stress and Mood Management
Intervention type(s): Behavioral; Behavioral
Intervention description(s): This 3-hour web-based program consists of four 45-minute modules that are interactive and range in number of segments (1-14) and types of activities. Each of the modules involves interactivity, didactic activities and two episodes of a serial drama ("Squad"), which allow for the modeling of positive behaviors and illustrate both positive and negative outcome expectations. Behaviors modeled include drinking safely (e.g., eating before drinking, pacing, and drinking water), having a game plan before going out, communicating with male sex partners, engaging in protective dating behaviors, use of resistance strategies, self-defense strategies and bystander intervention with the goal of reducing risk of being sexually assaulted.; This 3-hour general health promotion web-based program consists of four 45-minute modules ("Stress Management", "Managing Depression", "Managing Anxiety", and "Treatments that work") that provide a range of activities related to reducing day-to day stress and alleviating anxiety through meditation and exercise.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
A Study to Investigate the Effects of Cytochrome P450 1A2 Induction by Ritonavir on BMS-986165 Drug Levels and Effects in Healthy Participants
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      The Study of Cytochrome P450 1A2 Induction by Ritonavir on the drug effects of BMS-986165 in
      Healthy Participants
    


Intervention name(s): BMS-986165; Ritonavir
Intervention type(s): Drug; Drug
Intervention description(s): Dose 1; 100 mg
Intervention MeSH terms: Ritonavir; Deucravacitinib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research