bioihbjkbjnl/mcl2 huggingface dataset:
Intraoperative Sedatives and Postoperative Deilirium
Condition: Lower Extremity Problem; Delirium; Propofol; Dexmedetomidine
MeSH terms: Delirium
Study type: Interventional

Summary: 
      Delirium occurs commonly in elderly patients. Its incidence after orthopedic surgery has been
      reported to be 5-61%. Delirium is classified into three sub-types: Hypoactive, hyperactive,
      and mixed. Although hyperactive delirium is not as common as hypoactive delirium, the
      abnormal behavior pattern of hyperactive delirium, such as agitation, confusion, or
      aggressiveness, is considered to be harmful to patients and medical personnel. Thus, it is
      important to promptly manage such behaviors associated with hyperactive delirium.
      Intraoperative sedation plays an important role in relieving anxiety or stress response of
      patients. Propofol-a common sedative agent-was reported to cause delirium more frequently,
      compared with dexmedetomidine, in post-cardiac surgery patients or mechanically-ventilated
      patients in the intensive care unit (ICU). In addition to the benefits of reducing opioid
      consumption and postoperative nausea/vomiting, dexmedetomidine is most often used for ICU
      sedation or procedural sedation. However, there has not been any prospective randomized study
      investigating how intraoperative dexmedetomidine sedation during regional anesthesia affects
      postoperative consciousness, perception, memory, behavior, emotion, and so on. In this study,
      based on the hypothesis that intraoperative dexmedetomidine sedation may reduce the incidence
      of abnormal psycho-motor behavior compared with propofol sedation, investigators
      prospectively will investigate the incidence of postoperative delirium in elderly patients
      who undergo orthopedic surgery with regional anesthesia.
    


Intervention name(s): Propofol; Dexmedetomidine
Intervention type(s): Drug; Drug
Intervention description(s): Propofol is infused continuously via the target-controlled infusion device (Orchestra®, Fresenius vial, Brezins, France), and the effect-site concentration is maintained within 0.5-2.0 μg/ml.; Dexmedetomidine is diluted with 0.9% saline to make a concentration of 4 μg/ml. As a loading dose, 1 μg/kg dexmedetomidine is administered over a 10-min period, which is then administered continuously at 0.1-0.5 μg/kg/h.
Intervention MeSH terms: Dexmedetomidine; Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Onychomycosis: Diagnosis and Prevalence in Diabetic Neuropathic Patients
Condition: Prevalence of Onychomycosis; Diabetic Neuropathic Patients; Diagnostic of Onychomycosis; Patients Clinically Suspected of Onychomycosis; Reliability of the Diagnosis of Onychomycosis
MeSH terms: Onychomycosis; Disease
Study type: Observational

Summary: 
      The prevalence of onychomycosis among diabetic patients is still a debated question as well
      as the best way to diagnose the disease. We conducted a prospective study to assess the
      prevalence of onychomycosis in diabetic neuropathic (DN) patients clinically suspected of
      this disease and to assess the reliability of the diagnosis of onychomycosis.
    

Detailed description: 
      From December 2000 to January 2005, we followed 100 successive diabetic patients, type 1 and
      type 2, suffering from (DN). At baseline we assessed age, gender, medical history and
      medications, foot insensitivity defined by a vibration perception threshold (VPT) >25 volts
      and onychomycosis by clinical diagnosis.

      Multiple samples of the most affected nail, often the big toe, were taken. A potassium
      hydroxide (KOH) test was done by 2 independent and blinded investigators and a culture in a
      laboratory (lab) specialized in mycology.

      Pictures of the nails and particularly of the sampled nail were taken. Apart from the
      laboratory results, two independent and blinded dermatologists gave their diagnosis looking
      at the pictures.
    

Observational model: Defined Population
Time perspective: Other
Keywords: onychomycosis; diabetic neuropathic patients; reliability of the diagnostic of onychomycosis
Chest Compression Technique in Infants
Condition: Atelectasis
MeSH terms: Pulmonary Atelectasis
Study type: Interventional

Summary: 
      Evaluate the effect of chest manual compression technique (CCT) in the variables of
      oxygenation, hemodynamic and respiratory work in infants with respiratory diseases that are
      associated with atelectasis.
    


Intervention name(s): CHEST COMPRESSION TECHNIQUE (CCT)
Intervention type(s): Other
Intervention description(s): The CCT was held with the placement of one of the hands were not engaged in. The following has been applied a symmetric oblique direction, pressure from top to bottom on the half thorax rib cage so that it went according to the complacency of the ribcage. This pressure was applied in the expiratory phase and held for 10 seconds, totaling 6 repetitions of the maneuver during 60 seconds. The other hand held on the contralateral iliac crest to stabilize the patient. The technique was held during 5 consecutive minutes with range of a respiratory incursion every 60 seconds. Immediately after and 10 minutes after the end of the application of the technique, the data was measured again.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Study to Compare Gastric Inhibition of Two Proton Pump Inhibitors (CL2008-18)(P07815)(COMPLETED)
Condition: Human Experimentation
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will determine differences between Proton Pump Inhibitors (PPI) formulations
      relative to their effects on gastric acidity.
    


Intervention name(s): Zegerid; Prevacid®
Intervention type(s): Drug; Drug
Intervention description(s): Zegerid (20 mg omeprazole/ 1100 mg sodium bicarbonate) taken with approximately 2 oz of water once daily for 7 days.; Prevacid (15 mg lansoprazole) taken with approximately 2 oz of water once daily for 7 days.
Other intervention name(s): omeprazole/sodium bicarbonate, SCH 900934; lansoprazole
Intervention MeSH terms: Omeprazole; Lansoprazole; Omeprazole, sodium bicarbonate drug combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Dried Cabernet Grapes and Cardiovascular Risk Markers
Condition: Healthy, Postmenopausal Women
Study type: Interventional

Summary: 
      This study assesses the acute effects of dried Cabernet grape intake on vascular function and
      platelet reactivity in postmenopausal women. Previous studies from this lab and others have
      demonstrated acute effects on vascular function and platelet reactivity from phenolic-rich
      food sources. Postmenopausal women are suggested as the study group, as they are likely to
      have compromised vascular function due to the loss of protective estrogen, and have been the
      study group for past and present research projects in this lab.
    

Detailed description: 
      The initiation and progression of atherosclerotic cardiovascular disease (CVD) is
      multifactorial in nature, and is currently thought of as a chronic inflammatory condition. To
      reduce the risk of CVD and its associated health care costs in California and elsewhere,
      nutrition and health recommendations strongly advocate the consumption of a diet rich in
      fruits and vegetables. Such recommendations are based largely on epidemiological data; the
      mechanisms underlying the putative positive effects of plant food-rich diets are poorly
      defined and an area of active debate.

      In addition to essential vitamins and minerals, fruits and vegetables contain a number of
      bioactive compounds that may be involved in vascular function. In this regard,
      epidemiological studies have noted a significant inverse relationship between the intake of
      plant foods rich in polyphenols and the risk of both all-cause mortality and CVD. For
      example, the "French paradox" refers to diet patterns that, despite being high in saturated
      fat, are associated with a relatively low cardiovascular risk, which may be due, in part, to
      a robust intake of polyphenols found in red wine, grapes, and other plant foods. Red wine
      contains an array of phytochemicals that have been proposed to improve cardiovascular health,
      with a great focus on polyphenols. However, grape products such as dried cabernet grapes also
      contain substantial amounts of polyphenols that may be vasculoprotective.
    

Intervention name(s): Raisin Treatment; Bagel Control
Intervention type(s): Other; Other
Intervention description(s): Subjects will consume 3.2oz of dried Cabernet grapes during a single intervention time point.; Subjects will consume 95g of whole wheat bagel during a single intervention time point.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Obesity-asthma Endophenotype and Diaphragm Mobility in Adolescence
Condition: Obesity; Asthma
MeSH terms: Asthma; Obesity
Study type: Observational

Summary: 
      Obesity and asthma share changes that may begin in the fetal development phase. The
      endophenotype obesity-asthma presents as main characteristic a pattern of inflammatory
      response different from the habitual Th2 profile of cytokines. In these obese patients,
      possible changes in the diaphragm muscle can directly influence the dynamics of pulmonary
      ventilation significantly.

      Due to the importance of the diaphragm in pulmonary ventilation, this study will be performed
      to verify possible alteration in the excursion and diaphragmatic thickness of adolescents
      with endophenotype obesity-asthma. In parallel, the possible underlying etiopathogenic
      substrate of this endophenotype will be explored through the dosing of muscle enzymes and
      inflammatory cytokines and obesity hormones.
    


Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        108 adolescents aged 12 years to 21 years will be recruited, of all sexes
      
Biospecimen description: 
      Serum
    
Keywords: obesity; asthma; diaphragm excursion; pulmonary function test
Proton Therapy for Unresectable Cancer (CA) of Pancreas
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Study type: Interventional

Summary: 
      The purpose of this study is to find out what effects, good and/or bad, proton radiation and
      chemotherapy has on you and your pancreatic cancer.
    

Detailed description: 
      Chemotherapy:Capecitabine on radiation days

      Proton radiation over 7 weeks

      Consolidation Chemotherapy:Gemcitabine
    

Intervention name(s): Proton radiation and chemotherapy
Intervention type(s): Radiation
Intervention description(s): Proton radiation 59.4 CGE in 33 fx at 1.8 CGE per fx over 7 weeks .
Chemotherapy:
Capecitabine (Xeloda ®) 1,000 mg by mouth twice a day, 5 days/week (M-F) Consolidation Chemotherapy: Suggested Regimen - Gemcitabine total of 12 doses
Other intervention name(s): Capecitabine; Xeloda; Gemcitabine; Gemzar
Intervention MeSH terms: Gemcitabine; Capecitabine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pancreatic cancer; Unresectable; Proton radiation; Chemotherapy
Effectiveness and Safety of STYLAGE® HYDRO in the Treatment of Face, Neckline Area and Neck
Condition: Aging
Study type: Interventional

Summary: 
      FLASH Study is a Post-Market Follow-Up PCMF designed to evaluate the tolerance and efficacy
      of STYLAGE Hydro by using a satisfaction questionnaire.
    

Detailed description: 
      This is a prospective, in open, single arm and multicentric study designed to evaluate the
      tolerance and efficacy of STYLAGE Hydro.

      Patients will be injected up to 2 mL of STYLAGE Hydro per area at each session. Three
      injection sessions 2 weeks apart are planned: one at visit 1 (D0), one at visit 2 (W2) and
      one at visit 3 (W4).

      Proportions of subjects who are satisfied on the face 6 weeks after treatment initiation will
      be assessed. For each question of the questionnaire, the subjects who are satisfied are
      defined as subjects who rated "Somewhat agree", "Agree" or "Totally agree". Global aesthetic
      improvement according to independent evaluator and subjects' satisfaction will also be done
      during other visits. Safety parameters will be evaluated during the study period.
    

Intervention name(s): STYLAGE Hydro
Intervention type(s): Device
Intervention description(s): 3 sessions of injections (J0, J14 and J28)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hyaluronic acid; Injection; Healthy subjects; Prospective; Single arm; ISR
In the Prediction of Recurrence and Progression of NMIBC; EORTC or CUETO or Both?
Condition: Bladder Cancer; Disease Progression; Recurrent Bladder Cancer
MeSH terms: Urinary Bladder Neoplasms; Disease Progression
Study type: Interventional
Phase: Phase 4

Summary: 
      Investigators aimed to evaluate the performance of The European Organization for Research and
      Treatment of Cancer(EORTC) and the Spanish Urology Association for Oncological
      Treatment(CUETO) risk tables on all non-muscle invasive bladder cancer patients(NMIBC), and
      those not treated with BCG and treated with BCG separately.
    

Detailed description: 
      Risk tables can be used for the prediction of recurrence and especially progression of
      nonmuscle invasive bladder cancer .The European Organization for Research and Treatment of
      Cancer(EORTC) developed a risk table,which provides a scoring system for recurrence and
      progression risk.The EORTC risk table includes these factors: number of tumors,tumor
      size,prior recurrence rate,T stage,presence of carcinoma in situ(CIS),and grade for NMIBC
      patients not treated by maintenance bacillus Calmette-Guerin(BCG) instillation therapy.The
      Spanish Urology Association for Oncological Treatment(CUETO)later proposed a modified model
      to be used for patients only treated with BCG instillation.This risk table includes these
      factors:age,gender,recurrent tumor,number of tumors,T stage,CIS,and grade.

      There is no risk table that can be used for NMIBC patients treated or not treated with
      BCG.Should we use the EORTC risk table for patients not treated with BCG and the CUETO table
      only for those treated with BCG or is one of them sufficient to predict recurrence and
      progression in all patients?The main aim of this study was to compare the utility of the
      EORTC and CUETO risk tables in all patients, and separately in patients not treated with BCG
      and treated with BCG.
    

Intervention name(s): Intravesical BCG instillation
Intervention type(s): Procedure
Intervention description(s): ıntravesical BCG instillations were done two weeks after transurethral resection of bladder cancer
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: EORTC; CUETO; bladder neoplasm; disease progression; recurrence
Phase 1/2a Study on Allogeneic Osteoblastic Cells Implantation in Delayed-Union Fractures
Condition: Long Bone Delayed-Union Fracture
MeSH terms: Fractures, Bone; Fractures, Ununited
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Fracture healing is a complex physiological process caused by interaction of cellular
      elements, cytokines and signaling proteins, which results in the formation of new bone. There
      is for now no universally accepted approach to evaluate the progression of fracture healing.
      Typically, a fracture is considered as a delayed-union when the bone has not united within a
      period of time that would be considered adequate for bone healing. Delayed-union suggests
      that union is slow but will eventually occur without additional surgical or non-surgical
      intervention, whereas non-union is defined as the cessation of all reparative process of
      healing.

      The incidence of impaired healing is estimated to range from 5 to 10% of all long bone
      fractures, depending on the fracture site, the type and degree of injury, among other
      factors. Currently the treatment of choice remains bone allograft or autograft. This
      procedure shows in general good results but requires an invasive surgery of several hours
      under general anesthesia, followed by a few days of hospitalization. Because of this, major
      complications have been reported in up to 20-30% of patients.

      The present Phase 1/2a study aims at demonstrating the safety and efficacy of ALLOB®, a
      proprietary population of allogeneic osteoblastic cells, in the treatment of delayed-union
      fractures of long bones. In this study, delayed-union is defined at the time of screening as
      an absence of healing of minimum 3 months and maximum 7 months (+/- 2 weeks) after the onset
      of the fracture.
    


Intervention name(s): ALLOB® implantation
Intervention type(s): Drug
Intervention description(s): Each patient will undergo a single administration of ALLOB® into the delayed-union site under anesthesia.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Delayed-Union Fractures; Impaired Healing; Fractures; Orthopedics; Bone; Musculoskeletal Disorders
Challenging the Gold Standard: Pilot Study Comparing Continuous Glucose Monitoring System (CGMS), Capillary Glucose Monitors and 3 Hour Glucose Tolerance Test (GTT) to Diagnose Gestational Diabetes Mellitus (GDM)
Condition: Diabetes, Gestational
MeSH terms: Diabetes, Gestational; Diabetes Mellitus
Study type: Observational

Summary: 
      The purpose of this research study is to compare 3 methods of measuring blood glucose (blood
      sugar) levels to see if the finger-stick method or the continuous glucose monitoring system
      is better than or as good as the 3 hour glucose tolerance test (GTT) for the diagnosis of
      gestational diabetes.
    

Detailed description: 
      The rate of gestational diabetes and fetal macrosomia is increasing. Moreover, it appears
      that many macrosomic infants are born to non-diabetic mothers. However, this presents the
      question of whether our current accepted means of diagnosis is reflecting the true prevalence
      of GDM. The 3-hour GTT measures glycemic control over a limited period of time. A more
      prolonged period of monitoring makes more physiologic sense, as it would paint a picture of a
      patient's overall trend before a diagnosis can be confirmed or excluded. Given the ability of
      the CGMS and capillary glucose monitor to follow glycemic trends over an extended time
      period, these methods may prove more effective at identifying patients with abnormal glucose
      tolerance. As these modalities test the patients in their native environments, the effect of
      dietary changes prior to the testing period may be minimized, potentially providing an more
      accurate assessment of abnormal glucose utilization. Furthermore, both modalities should be
      more cost-effective than the 3- hour GTT.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Pregnant women between 18 & 50 years old who are having a 3 hour GTT as directed by their
        doctor
      
Keywords: GDM; Gestational Diabetes; GTT; CGMS
To Evaluate Efficacy and Tolerability of Sodium Bicarbonate Toothpaste and Its Effect on Opportunistic or Resistant Organisms
Condition: Oral Hygiene
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will compare the Gingival Bleeding and Gingival Inflammation following twice daily
      use of a sodium bicarbonate experimental dentifrice compared to a 0% sodium bicarbonate
      toothpaste after 24 weeks of use. The study will be conducted at Salus Research, Inc.
      Participants will be recruited from their database and by use of an external recruitment
      agency
    

Detailed description: 
      This study will be a single-centre, examiner blind, two treatment, parallel group, stratified
      (by baseline number of bleeding sites smoking status and bacterial sampling) randomized
      clinical study. At the screening visit, following provision of written informed consent,
      eligible participants will be provided with a standard toothpaste and toothbrush for brushing
      once in at the clinic and for approximately one week use at home until the baseline visit.
      Participants will be asked to abstain from brushing over a 12 hour period prior to the
      Baseline visit. At the baseline visit an oral soft tissue (OST) assessment, Modified Gingival
      Index (MGI) and Bleeding Index (BI), and then dental plaque assessment will be performed.
      Participants will be stratified according to their baseline number of bleeding sites, smoking
      status and whether selected for bacterial sampling. Participants will be then randomized into
      one of two treatment groups. After using, their assigned treatment twice daily at home for 6
      weeks (visit 3), 12 weeks (visit 4) and 24 weeks (visit 5), participants will return to the
      site with overnight plaque at approximately the same time of day as the Baseline visit if
      possible. Participants will undergo a full OST examination and the recording of any Adverse
      Events (AEs). Participants will then undergo MGI, BI followed by dental plaque assessment.
      Microbiological samples will be collected on a subset of 50 participants (Determined by first
      50 participants randomized).
    

Intervention name(s): Sodium bicarbonate and sodium fluoride; Sodium fluoride
Intervention type(s): Drug; Drug
Intervention description(s): Experimental toothpaste containing sodium bicarbonate experimental dentifrice plus 1150 parts per million (ppm) fluoride as sodium fluoride; Comparator toothpaste containing 1100 ppm fluoride as sodium fluoride
Intervention MeSH terms: Listerine; Fluorides; Sodium Fluoride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
A Randomized Controlled Trial of Routine Shave Margins Versus Standard Partial Mastectomy in Breast Cancer Patients
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      This research study is designed to look at whether the routine use of shave margins (by
      taking extra tissue at the time of partial mastectomy surgery) will reduce the chances of
      having positive surgical margins requiring another surgical procedure, and whether this
      affects the long-term chances of getting cancer back in your breast.
    


Intervention name(s): Shave margins; No Shave Margins
Intervention type(s): Procedure; Procedure
Intervention description(s): Partial mastectomy with shave margins.; Partial mastectomy without shave margins.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Alternate Formula Feedings in Formula Intolerant Infants
Condition: Gastrointestinal Tolerance
Study type: Interventional

Summary: 
      This study assessed tolerance improvement of a formula change in healthy term infants with
      perceived intolerance to their current milk-based formula feeding.
    


Intervention name(s): Infant Formula 1; Infant Formula 2
Intervention type(s): Other; Other
Intervention description(s): Feed ab libitum; Feed ab libitum
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)