bioihbjkbjnl/mcl2 huggingface dataset:
Pre-warmed Intravenous Fluids and Monitored Anesthesia Care
Condition: Hypothermia
MeSH terms: Hypothermia
Study type: Interventional

Summary: 
      The aim of the study is to compare effect of pre-warmed intravenous fluids on the early
      outcomes in ambulatory patients undergoing monitored anesthesia care.
    

Detailed description: 
      Monitored anesthesia care (MAC) has been increasing in fast track anesthesia for ambulatory
      or outpatient surgery. MAC provides lower anesthetic agents than general anesthesia, however
      it has been shown to result high anesthetic complication rate because of negligent
      monitoring. Therefore, aim of this study is to investigate the effect of pre-warmed
      intravenous fluids on the core body temperature and the early outcomes.
    

Intervention name(s): Pre-warmed fluids; Room temperature fluids
Intervention type(s): Other; Other
Intervention description(s): IV fluid will be stored at 41℃ set hot cabinet for 8hours; Room temperature fluid will be stored at ambient temperature
Other intervention name(s): Warming intravenous (IV) fluid; No warming intravenous fluids
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Prewarmed fluid; monitored anesthesia care; core body temperature; anesthetic satisfaction
A Study Comparing the Effects of Famotidine Pretreatment and of Food on the Relative Bioavailability of BMS-986165 in Healthy Volunteers
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of this study is to evaluate the effects of food and pH on the relative
      bioavailability (BA) of the tablet formulation of BMS-986165 in healthy volunteers
    


Intervention name(s): BMS-986165; Famotidine
Intervention type(s): Drug; Drug
Intervention description(s): Single dose; Single dose
Intervention MeSH terms: Deucravacitinib; Famotidine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Inspiratory Muscle Training in Children With Cerebral Palsy
Condition: Cerebral Palsy; Respiration; Decreased
MeSH terms: Respiratory Aspiration; Paralysis; Cerebral Palsy
Study type: Interventional

Summary: 
      Even if cerebral palsy not directly effect respiratory system, impairment of nervous and
      muscle systems, because of the brain damage, may cause respiratory functions impairment. In
      literature, it has been showed that children with cerebral palsy have decreased respiratory
      muscle strength and associated with trunk control, quality of life and respiratory functions.
      But, there is no study in literature that aims to increase respiratory muscle strength in
      these children. Hence, the aim of this study is to investigate effects of inspiratory muscle
      training on respiratory functions, trunk control, activities of daily living, functional
      exercise capacity and quality of life in children with cerebral palsy.
    

Detailed description: 
      A convenience of children with hemiparetic and diplegia CP, 7-14 years, is going to recruited
      from Gazi University, Faculty of Health Science, Department of Physiotherapy and
      Rehabilitation. Patients will randomly allocate to either a treatment group or control group.
      The treatment group will receive inspiratory muscle training at 30-40% of maximal mouth
      pressure, the control group will receive sham inspiratory muscle training at a fixed work
      load, 5% of maximal mouth pressure. Groups are going to train for a total of 30 min/d, 7
      days/week, for 6 weeks. Before and after treatment, every each of patients pulmonary function
      test will be evaluated with using spirometry, respiratory muscle strength using with
      electronic mouth pressure device, trunk control with using trunk control measurement scale,
      activities of daily living using with Pediatric Evaluation of Disability Inventory (PEDI),
      functional exercise capacity usin with six minute walk test (6MWT) and quality of life using
      with Cerebral Palsy Quality of Life Questionnaire (CPQOL).
    

Intervention name(s): Threshold (IMT)
Intervention type(s): Device
Intervention description(s): Training is going to perform by using a pressure threshold- loading device (Threshold, IMT, USA) used to inhale against a same-pressure load every inhalation for strengthening primarily the diaphragm and rib cage muscles. The device pressure is adjusted according to PImax, and reliability/reproducibility has been demonstrated.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: cerebral palsy; inspiratory muscle training
Replication of the ISAR-REACT 5 Antiplatelet Trial in Healthcare Claims Data
Condition: Acute Coronary Syndrome
MeSH terms: Acute Coronary Syndrome
Study type: Observational

Summary: 
      Investigators are building an empirical evidence base for real world data through large-scale
      replication of randomized controlled trials. The investigators' goal is to understand for
      what types of clinical questions real world data analyses can be conducted with confidence
      and how to implement such studies.
    

Detailed description: 
      This is a non-randomized, non-interventional study that is part of the RCT DUPLICATE
      initiative (www.rctduplicate.org) of the Brigham and Women's Hospital, Harvard Medical
      School. It is intended to replicate, as closely as possible in healthcare insurance claims
      data, the trial listed below/above. Although many features of the trial cannot be directly
      replicated in healthcare claims, key design features, including outcomes, exposures, and
      inclusion/exclusion criteria, were selected to proxy those features from the trial.
      Randomization is also not replicable in healthcare claims data but was proxied through a
      statistical balancing of measured covariates through standard practice. Investigators assume
      that the RCT provides the reference standard treatment effect estimate and that failure to
      replicate RCT findings is indicative of the inadequacy of the healthcare claims data for
      replication for a range of possible reasons and does not provide information on the validity
      of the original RCT finding.
    

Intervention name(s): Ticagrelor 90mg; Prasugrel 10mg
Intervention type(s): Drug; Drug
Intervention description(s): Any ticagrelor dispensing claim is used as the exposure group; Any prasugrel dispensing claim is used as the reference group
Intervention MeSH terms: Ticagrelor; Prasugrel Hydrochloride
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        This study will involve a new user, parallel group, retrospective cohort study design
        comparing ticagrelor 90 mg twice daily to prasugrel 10 mg daily. The patients will be
        required to have continuous enrollment during the baseline period of 180 days before
        initiation of ticagrelor or prasugrel (index date). We will restrict the analyses to
        patients with an acute coronary syndrome, with or without ST-segment elevation, who were
        scheduled to undergo coronary angiography.
p-AKT Expression on Clinical Outcomes in Malignant Lymphoma
Condition: Malignant Lymphoma; P13K-AKT Pathway Deregulation
MeSH terms: Lymphoma
Study type: Observational

Summary: 
      PI3K(phosphatidylinositol 3-kinase)/AKT pathway is an important oncogenic signaling pathway.
      However, clinical information about the significance of p-AKT expression in malignant
      lymphoma is not fully understood yet. In this study, we investigated the overexpression of
      p-AKT and its prognostic implication in malignant lymphoma.
    

Detailed description: 
      Recently, among diverse oncogenic signaling pathways, a number of studies have focused on the
      significance of oncogenic PI3K/AKT (phophatidylinositol 3-kinase/serine-threonine kinase,
      also known as protein kinase B [PKB]) pathway. PI3K(phosphatidylinositol 3-kinase)/AKT
      pathway phosphorylates and activates AKT as phosphorylated AKT (p-AKT) and plays a critical
      role promoting malignant phenotype and has prognostic significance in various solid cancers.

      However, a systematic approach on the impact of p-AKT overexpression on clinical outcomes has
      not been performed in malignant lymphoma.
    

Intervention name(s): p-AKT immunohistochemical staining
Intervention type(s): Other
Intervention description(s): p-AKT staining on the adequate paraffin-embedded biopsy specimen or unstained slides
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with malignant lymphoma who are treated in a tertiary hospital in Korea (Samsung
        Medical Center)
      
Biospecimen description: 
      paraffin-embedded biopsy specimen or unstained slides for immunostaining of p-AKT
Effect of Vitamin D Replacement on Insulin Sensitivity
Condition: Insulin Sensitivity
MeSH terms: Insulin Resistance; Vitamin D Deficiency; Hypersensitivity
Study type: Interventional
Phase: Phase 1

Summary: 
      Healthy subjects with low Vitamin D levels will be randomly assigned to either Vitamin D
      replacement or placebo for a period of 8 weeks. Insulin sensitivity will be measured before
      and after the intervention, and the changes will be compared between the two groups. This
      will help us understand if Vitamin D replacement improves insulin sensitivity. Serum Retinol
      Binding Protein 4 levels will also be measured to see if changes in insulin sensitivity are
      mediated by RBP4.
    


Intervention name(s): Ergocalciferols; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): ERgocaclciferol 50,000 units weekly for 8 weeks; matching placebo
Intervention MeSH terms: Ergocalciferols; Vitamin D
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: vitamin D deficiency, insulin sensitivity
Education and Group Support for Diabetic Hispanics
Condition: Diabetes Mellitus, Non-Insulin-Dependent
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The purpose of this ongoing work in Starr County, located on the Texas-Mexico border, is to
      conduct clinical studies to determine the effectiveness of diabetes self-management programs
      designed specifically for Mexican Americans. The programs meet national standards for
      diabetes self-management education. They are provided in community settings with the primary
      purpose of improving the health of Mexican Americans with diabetes and their family members,
      who either have diabetes or are at risk for developing diabetes.

      The diabetes self-management programs are provided in Spanish and are directed by bilingual
      Hispanic clinical nurse specialists, dietitians, and community health workers. Key elements
      of the programs include instruction on nutrition, self-monitoring of blood glucose, exercise,
      and other diabetes self-management topics, as well as group support to promote behavioral
      changes.

      In the original study (1994-1998), 256 Mexican American adults diagnosed with type 2 diabetes
      and 256 family members or other support persons were enrolled. For one year, the people with
      diabetes, along with their family members, attended small group sessions held in churches,
      community health clinics, adult day care centers, and schools. Information on the
      effectiveness of the program was collected at 3, 6, and 12 months; and annually thereafter.

      Findings of the original study suggested that the program had a positive impact on diabetes
      metabolic control. Levels of diabetes knowledge and rates of glucose self-monitoring and
      attendance suggested that a shorter program - one that incorporated critical elements of the
      previous successful strategy - might result in similar improvements. Thus, the goal of the
      new study, funded in June 1999, was to shorten the original program and to compare it to the
      previous successful program in terms of short- and long-term health outcomes.

      To identify key components of the previous program, we are exploring differences between
      subjects who successfully integrated self-care components of the program and who experienced
      significant improvements in metabolic control and those who were not as successful. The
      program is being revised and shortened, based on this information. Beginning in April 2000,
      we will start recruiting participants for the clinical trial of the revised program.
    


Intervention name(s): diabetes self-management education
Intervention type(s): Behavioral
Allocation: Non-Randomized
Primary purpose: Prevention
Keywords: diabetes mellitus, type 2; diabetes self-management education; diabetes self-care; blood glucose self-monitoring; health education; patient education
Study of the Role of PCSK9 and FXR in the Physiopathology of the Joint Dyslipidemia Associated to the Human Immunoresistance
Condition: Obesity
MeSH terms: Dyslipidemias
Study type: Interventional

Summary: 
      Experimental results are strongly suggesting that PCSK9 and FXR could occur in the
      physiopathology of human joined dyslipidemia. But no data in the literature can validate the
      potential role of these two genes in the lipidic and glucidic metabolism control in
      physiopathological situations. This protocol is based on the hypothesis that the expression
      levels of PCSK 9 and FXR are modified for some patients suffering from insulin resistance and
      dyslipidemia.
    


Intervention name(s): biopsy of muscle, of liver, and of adipose tissue; clamp euglycemic - hyperglycemic; diet; biopsies for biological and genetic analyses
Intervention type(s): Procedure; Procedure; Behavioral; Other
Intervention description(s): biopsy of muscle, of liver, and of adipose tissue; clamp euglycemic-hyperglycemic; diet; biopsies for biological and genetic analyses
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: bariatric surgery planned
Shock Wave Therapy in Individuals With Lateral Epicondylitis
Condition: Lateral Epicondylitis
MeSH terms: Tennis Elbow
Study type: Interventional

Summary: 
      A sample of 40 patients poststroke (24 males) was randomly allocated to either ESWT
      experimental (n=18) or conventional physiotherapy control group (n=20). All patients received
      5 sessions during the treatment program. The Visual Analog Scale (VAS) and Taiwan version
      Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire, and dynamometer (Maximal
      grip strength) for each participant were assessed before and after the treatment program.
    

Detailed description: 
      The participants in the experiment group received 5 consecutive sessions of ESWT for 5
      minutes. Treatment parameters for the shock wave therapy group were set similar to a previous
      study (Devrimsel et al., 2013) 2000 shock waves with 1.6 bar intensity and 16 Hz frequency
      were applied for five sessions using the Swiss DolorClast Master (EMS, Nyon, Switzerland).
      The participants in the control group received 5 sessions of conventional physical therapy
      intervention for 5 minutes. The control group intervention consists of a 1-minute friction
      massage over the common extensor tendon of the elbow, followed by 3 minutes therapeutic
      ultrasound with a frequency of 1.5 Hz, and a 1-minute ice massage over the common extensor
      tendon of the elbow. All participants used 10-cm lateral epicondyle bandages in the treatment
      period, while none of them received analgesic or anti-inflammatory drugs and received
      exercise programs.
    

Intervention name(s): Extracorporeal shock wave therapy; Conventional physiotherapy
Intervention type(s): Device; Other
Intervention description(s): The participants in the experiment group received 5 consecutive sessions of ESWT for 5 minutes. Treatment parameters for the shock wave therapy group were set similar to a previous study (Devrimsel et al., 2013) 2000 shock waves with 1.6 bar intensity and 16 Hz frequency were applied for five sessions using the Swiss DolorClast Master (EMS, Nyon, Switzerland). All participants used 10-cm lateral epicondyle bandages in the treatment period, while none of them received analgesic or anti-inflammatory drugs and received exercise programs.; The participants in the control group received 5 sessions of conventional physical therapy intervention for 5 minutes. The control group intervention consists of a 1-minute friction massage over the common extensor tendon of the elbow, followed by 3 minutes therapeutic ultrasound with a frequency of 1.5 Hz, and a 1-minute ice massage over the common extensor tendon of the elbow. All participants used 10-cm lateral epicondyle bandages in the treatment period, while none of them received analgesic or anti-inflammatory drugs and received exercise programs.
Other intervention name(s): Shock wave; Physiotherapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pain; Function
Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF-06700841 In Subjects With Moderate To Severe Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The objectives of this study are to evaluate the efficacy, safety, tolerability,
      pharmacokinetics, and pharmacodynamics of PF-06651600 (200 mg for 8 weeks followed by 50 mg
      for 4 weeks) dosed once daily and PF-06700841 (60 mg for 12 weeks) dosed once daily during an
      induction period of 12 weeks, followed by an open label extension period at doses of 50 mg
      and 30 mg of PF 06651600 and PF 06700841, respectively, for 52 weeks.
    


Intervention name(s): PF-06651600 Placebo; PF-06651600; Placebo PF-06700841; PF-06700841
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 12 weeks, followed by PF-06651600, 50 mg once daily (QD) for 52 weeks; 200 mg QD for 8 weeks, followed by 50 mg QD up to 56 weeks; 12 weeks, followed by PF-06700841, 30 mg QD for 52 weeks; 60 mg QD for 12 weeks followed by 30 mg QD for up to 52 weeks
Intervention MeSH terms: PF-06700841
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Application of 3-Dimensional Printing Guide Template and Pointed Lotus-style Regulator
Condition: Vertebral Fracture
MeSH terms: Fractures, Bone; Spinal Fractures
Study type: Interventional

Summary: 
      This study aims to analysis the efficacy of the 3D printing percutaneous guide template in
      combination with the pointed lotus-style regulator in percutaneous pedicle screw fixation.
    

Detailed description: 
      All thoracolumbar fractures patients receiving percutaneous pedicle screw fixation (PPSF)
      were enrolled and randomly divided into 3 groups. Patients in Group A received traditional
      PPSF, while patients in Group B received PPSF with flat end lotus-style regulator and
      patients in Group C received PPSF with pointed lotus-style regulator.
    

Intervention name(s): Pointed lotus root regulator and guide template aided PPSF; Flat ended lotus root regulator and guide template aided PPSF
Intervention type(s): Device; Device
Intervention description(s): 20 patients in group C received PPSF with pointed lotus-style regulator; 20 patients in group B received PPSF with flat ended lotus-style regulator
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: 3D printing guide template; pointed lotus-style regulator; thoracolumbar compression fracture; percutaneous pedicle screw fixation
The Epidemiologic Study of Human Cytomegalovirus（CMV） in Female Students of Xiamen University
Condition: Cytomegalovirus Infections
MeSH terms: Cytomegalovirus Infections
Study type: Observational

Summary: 
      In this study, 100 female students aged 18 to 30 years old in Xiamen University will be
      enrolled. On the first visit, blood, saliva and urine samples of all participants will be
      collected. Then saliva and urine samples will be collected at two-week interval until 6
      months. Serum samples will be tested the PP150-IgG titer. Saliva and urine samples will be
      used to test CMV DNA by PCR. The primary purpose of this study is to identify the
      relationship between baseline PP150-IgG titer and CMV infection.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        100 female students aged 18 to 30 years old will be recruited from Xiamen University.
      
Keywords: Cytomegalovirus
Examining the Effects of Neural Stimulation on Inhibitory Control and Cigarette Smoking
Condition: Tobacco Use Disorder
MeSH terms: Tobacco Use Disorder
Study type: Interventional

Summary: 
      The purpose of this research study is to examine the effects of theta-burst Transcranial
      Magnetic Stimulation on inhibitory control and smoking among adult cigarette smokers.
    


Intervention name(s): Intermittent Theta-burst stimulation (iTBS); Continuous Theta-burst stimulation (cTBS)
Intervention type(s): Device; Device
Intervention description(s): Theta-burst stimulation (TBS), a form of repetitive transcranial magnetic stimulation (rTMS), affects brain areas stimulated directly underneath the scalp and brain areas that are functionally connected. Theta-burst stimulation (TBS), a form of repetitive transcranial magnetic stimulation (rTMS), affects brain areas stimulated directly underneath the scalp and brain areas that are functionally connected.; Theta-burst stimulation (TBS), a form of repetitive transcranial magnetic stimulation (rTMS), affects brain areas stimulated directly underneath the scalp and brain areas that are functionally connected. Continuous TBS (cTBS) which is thought to temporarily dampen brain activity in that specific area.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science