bioihbjkbjnl/mcl2 huggingface dataset:
Sufentanil Infusion vs Sufentanil Bolus
Condition: Anesthesia
Study type: Interventional
Phase: Phase 4

Summary: 
      Randomized single blind controlled clinical trial to test the benefit of sufentanil infusion
      over bolus dosing to reduce time to extubation and reduced length of ICU stay.
    

Detailed description: 
      This study will compare Sufentanil bolus vs infusion and analyze which has a faster
      extubation time in participants who undergo routine cardiac surgery. The hypothesis is that
      routine cardiac surgery patients receiving sufentanil infusion will have a lower sufentanil
      concentration at the end of surgery and have a shorter time to extubation than participants
      receiving sufentanil bolus dosing even with similar total doses of sufentanil. The
      intervention will be Sufentanil infusion during surgery and evaluations will include
      Sufentanil blood concentrations, ICU and hospital length of stay and re-intubation rate. We
      will follow up with the participants through their ICU stay (primary objective) and hospital
      length of stay (secondary objective).
    

Intervention name(s): Sufentanil Infusion; Sufentanil Bolus
Intervention type(s): Drug; Drug
Intervention description(s): Intra-operative sufentanil infusion; Intra-operative sufentanil bolus
Other intervention name(s): Sufentanil; Sufentanil
Intervention MeSH terms: Sufentanil; Dsuvia
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Ertapenem Sodium (MK-0826) Versus Piperacillin/Tazobactam Sodium for the Treatment of Diabetic Foot Infections in Chinese Adults (MK-0826-061)
Condition: Infection; Diabetic Foot
MeSH terms: Infections; Communicable Diseases; Diabetic Foot
Study type: Interventional
Phase: Phase 3

Summary: 
      This study compared ertapenem sodium to piperacillin/tazobactam sodium for the treatment of
      moderate to severe diabetic foot infections. The primary hypothesis was that treatment with
      ertapenem sodium is non-inferior to treatment with piperacillin/tazobactam sodium, in
      achieving clinical improvement or cure.
    


Intervention name(s): Ertapenem sodium; Piperacillin/tazobactam sodium; Piperacillin/tazobactam-matching placebo; Amoxicillin/clavulunate potassium
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Ertapenem sodium, 1.0 g IV daily over 30 minutes at Hour 0 for 5 to 28 days; Piperacillin/tazobactam sodium, 4.5 g, IV every 8 hours, given over 30 minutes at Hours 0, 8, and 16 for 5 to 28 days; Placebo, IV over 30 minutes, 2 times per day at Hours 8 and 16 for 5 to 28 days; If clinically indicated, participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28
Other intervention name(s): MK-0826, INVANZ™; Tazocin™
Intervention MeSH terms: Amoxicillin; Tazobactam; Piperacillin; Ertapenem; Piperacillin, Tazobactam Drug Combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Infection; Diabetes complications; Diabetes wound infection; Soft tissue infection; Osteomyelitis; Diabetes mellitus
Patient Education in NorthTrondelag Hospital Trust
Condition: Diabetes Mellitus
Study type: Interventional

Summary: 
      The purpose of this randomised open study is to examine the effect of self-management program
      for diabetes patients.
    

Detailed description: 
      The primary aim in this study is HbA1c in addition to secondary aims like quality of life and
      coping.
    

Intervention name(s): Lifestyle counseling
Intervention type(s): Behavioral
Intervention description(s): Self-management group education
Other intervention name(s): Self-management
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Patient Education as a Topic; Self-Management Program; Health promotion; Self Efficacy; Quality of life
Immediate Versus Delayed Loading for Implants Retaining Mandibular Complete Overdenture
Condition: Bone Loss; Dental Implant
Study type: Interventional

Summary: 
      The aim of this study will be to compare the amount of marginal bone height changes between
      immediate and delayed loading for immediately inserted implants used as abutments of
      mandibular overdenture.
    


Intervention name(s): Immediate loading of the implants; Delayed loading of the implant
Intervention type(s): Other; Other
Intervention description(s): Patients of this group will be rehabilitated by implant-retained mandibular overdenture with immediate loading of the implants as opposed to conventional maxillary complete dentures.; Patients of this group will be rehabilitated by implant retained mandibular overdenture with delayed loading of the implants (after 3 months) opposed by conventional maxillary complete dentures
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Egcg, a dyrk1a Inhibitor as Therapeutic Tool for Reversing Cognitive Deficits in Down Syndrome Individuals.
Condition: Down Syndrome
MeSH terms: Down Syndrome; Syndrome; Cognition Disorders; Cognitive Dysfunction
Study type: Interventional
Phase: Phase 2

Summary: 
      There is a mounting evidence of the modulation properties of the major catechin in green tea,
      epigallocatechin-3-gallate (EGCG), on dual specificity tyrosine-phosphorylation-regulated
      kinase 1A (DYRK1A) gene overexpression in the brains of DS mouse models.The aims are to
      investigate the clinical benefits and safety of EGCG administration in young adults with DS,
      to establish short-term EGCG effects (three months) on neurocognitive performance, and to
      determine the persistency or reversibility of EGCG related effects after three months of
      discontinued use.
    


Intervention name(s): Epigallocatechin-3-gallate (EGCG); Placebo
Intervention type(s): Dietary Supplement; Drug
Intervention description(s): EGCG normally works as a dietary supplement. EGCG administration in Down syndrome patients will result in an improvement of their cognitive performance.A a daily oral dose containing 9 mg/kg (range 6.9-12.7) of EGCG is given during three months.; No active treatment is given.
Intervention MeSH terms: Epigallocatechin gallate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Transcutaneous Electrical Nerve Stimulation for Tissues Perfusion
Condition: Renal Function Disorder; Critical Illness; Critical Illness Myopathy
MeSH terms: Critical Illness
Study type: Interventional

Summary: 
      The aim of this study is to determine the effect of transcutaneous electrical nerve
      stimulation in mechanically ventilated patients on the lower limb and renal tissue perfusion.
    


Intervention name(s): trans-cutaneous electrical nerve stimulation.; Sham TENS
Intervention type(s): Device; Device
Intervention description(s): • Patients assigned to the EMS group received daily EMS sessions of both lower extremities starting from the second day for 5days.; Patients in the control group will receive sham TENS.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Supportive Care
PK/PD Biosimilarity Study of Gan & Lee Insulin Glargine Injection vs.US & EU Lantus® in Type 1 Diabetes Mellitus Patients
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary objectives:

      To demonstrate biosimilarity with regard to the total and maximum pharmacokinetic exposure
      during one dosing interval (AUC ins. 0-24h, Cins.

      max) of Gan & Lee Insulin Glargine with Lantus® (US RLD / EU RP) in subjects with type 1
      diabetes

      To demonstrate biosimilarity with regard to the total and maximum pharmacodynamic response
      during one dosing interval (AUC GIR.0-24h, GIR max) of Gan & Lee Insulin Glargine with
      Lantus® (US RLD / EU RP) in subjects with type 1 diabetes

      Secondary objectives:

      To compare the pharmacokinetic and pharmacodynamic properties of Gan & Lee Insulin Glargine
      and of Lantus® (US RLD / EU RP)

      To assess the safety and tolerability of Gan & Lee Insulin Glargine and of Lantus® (US RLD /
      EU RP)
    


Intervention name(s): Gan & Lee Insulin Glargine Injection
Intervention type(s): Drug
Intervention description(s): All IMPs will be administered as a 0.5 U/kg single subcutaneous dose by a pre-filled pen.
Intervention MeSH terms: Insulin Glargine
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: The trial will be a randomized, double-blind, multicenter, single-dose, 3-way crossover, 3-treatment, euglycemic glucose clamp trial in male subjects with type 1 diabetes mellitus
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Diabetes; Diabetes Type 1; Type 1; Basal; Insulin; Glargine; T1DM; Diabetes Mellitus; Insulin Dependent Diabetes
A Clinical Study Investigating the Comparability of Somatrogon in Two Different Drug Product Presentations
Condition: Healthy Male Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, single-center, open-label randomized, 2×2 crossover (Ref Test | Test Ref)
      study with a washout of two weeks to establish bioequivalence between single dose of
      somatrogon in a PEN to somatrogon in VIAL administered sc in healthy male volunteers.
    

Detailed description: 
      The subjects will undergo a screening period (Day -28 to -1), and when eligible for study
      participation will be randomized to receive one sc injection of one of two somatrogon drug
      product presentations on Day 0, either the PEN or VIAL presentation. A series of blood draws
      and study procedures will be carried out over the course of the next 10 days to evaluate the
      subjects. Following a two week washout period, the subjects will be brought back to the
      clinic to receive the other somatrogon drug product presentation, and once again followed for
      the next 14 days to study completion.
    

Intervention name(s): Somatrogon
Intervention type(s): Drug
Intervention description(s): A single dose of 12 mg of somatrogon will be injected as one sc injection to the arm on each dosing day (Day 0 and Day 14).
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This is a Phase 1, single-center, open-label randomized, 2×2 crossover (Ref Test | Test Ref) study with a washout of two weeks to establish bioequivalence between single dose of somatrogon in a PEN to somatrogon in VIAL administered sc in healthy male volunteers.
Masking: None (Open Label)
Primary purpose: Other
Impact of a Mailed Educational Reminder on Fecal Occult Blood Testing (FOBT): A Randomized Controlled Trial
Condition: Colon Cancer
MeSH terms: Colonic Neoplasms
Study type: Interventional

Summary: 
      The purpose of our randomized controlled trial is to determine whether mailed educational
      reminders would increase fecal occult blood test (FOBT) card return rates and, therefore,
      improve patient compliance with colonrectal cancer (CRC) screening.

      We will conduct a randomized, controlled trial to evaluate the hypothesis that compliance to
      FOBT referrals is at least 10% greater among patients who receive mailed educational
      reminders on the importance of CRC screening. The study will be conducted in Veteran Affairs
      Medical Center and surrounding VA clinics in San Diego.
    

Detailed description: 
      Colorectal cancer (CRC) is the third most common cancer in men and women in the United States
      with an estimated 147,000 new cases and more than 56,000 deaths each year. Early detection of
      colon cancer and removal of precancerous adenomatous polyps have been shown to reduce its
      morbidity, mortality and incidence. There are several recommended CRC screening tests,
      including fecal occult blood test (FOBT), flexible sigmoidoscopy, air-contrast barium enema,
      and colonoscopy. In the VA, FOBT is the predominant screening test for CRC, however patient
      compliance is low. Numerous studies have evaluated patient participation in CRC screening
      programs and FOBT card return rates, all of which have shown patient adherence was
      suboptimal. To date, there are no studies that have evaluated whether mailed educational
      reminders can improve FOBT compliance. The purpose of our randomized controlled trial is to
      determine whether mailed educational reminders would increase FOBT card return rates and,
      therefore, improve patient compliance with CRC screening.
    

Intervention name(s): Mailed Educational Reminder
Intervention type(s): Other
Intervention description(s): 1 page educational reminder that reminds the patient to return their FOBT cards back to the VA laboratory. In addition, it also contains reasons why colon cancer screening is important.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Screening
Keywords: colon cancer screening; mail reminders; fecal occult blood test; compliance
Accessing the Driving Skills After the Endoscopy of Intravenous Anesthesia by Driving Simulator
Condition: Driving
Study type: Interventional

Summary: 
      The purpose of this study is to assess the driving and cognitive ability of gastrointestinal
      endoscopy patients at different time points after intravenous anesthesia (propofol for
      example), and to explore whether the driving and cognitive ability have a relationship with
      the blood concentration of propofol or not.
    

Detailed description: 
      20-70 year-old volunteers who hold legitimate licenses were recruited to have gastroscopy or
      colonoscopy under intravenous anesthesia with propofol, and before endoscopy using driving
      simulator and NCT to measure patients' driving ability and cognitive function as a baseline,
      in the same way, assessing patients' driving ability and cognitive function after 2h, 4h of
      the endoscopy , meantime collecting blood samples and separating blood plasma, using HPLC
      (High Performance Liquid Chromatography) to measure blood concentration of propofol.
    

Intervention name(s): Endoscopy of Intravenous Anesthesia; Driving Simulator; Propofol
Intervention type(s): Procedure; Device; Drug
Intervention description(s): The dose of intravenous anesthesia drug and time was controlled by the anesthesiologist,endoscopists were responsible for gastroscopy or colonoscopy , nurses assisted endoscopists with biopsy.Each subject's initial dose of propofol were set at 2mg / kg, and were added properly by anesthesiologists additional according to the subjects' intraoperative sedation or surgical time.; 2mg / kg
Intervention MeSH terms: Propofol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Propofol; gastroscopy and colonoscopy; driving simulator; driving ability; cognitive function; patients
A Study of Donanemab (LY3002813) in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to assess how fast donanemab (LY3002813) gets into the
      blood stream and how long it takes the body to remove it when administered as single dose in
      healthy participants. The study will also evaluate the safety and tolerability of donanemab.
      The study will last up to approximately 22 weeks.
    


Intervention name(s): Donanemab
Intervention type(s): Drug
Intervention description(s): Administered IV.
Other intervention name(s): LY3002813
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
(18)F-FDG PET Database of Adult Healthy Individuals
Condition: Healthy
Study type: Interventional

Summary: 
      Epilepsy is the most common chronic neurological disorder in the world, affecting more than
      50 million people worldwide.

      Approximately 35% of patients with epilepsy are refractory to all available antiepileptic
      drugs. Focal Hypometabolism on interictal [18F]-FDG PET is a hallmark of the Seizure Onset
      Zone as well as surrounding areas. Using [18F]-FDG PET is thus particularly useful to
      determine the seizure onset zone of epileptic patients and thus to guide surgical treatment
      when antiepileptic drugs fail.

      Interpretation of PET images primarily relies on standard visual analysis, but statistical
      analysis, with the widely used Statistical Parametric Mapping (SPM) software improves the
      diagnostic yield of PET. Over the past years, some authors have thus reported that the use of
      SPM can result in greater sensitivity and specificity of PET imaging in patients with partial
      epilepsy.

      In order to perform statistical analysis of PET images to compare brain metabolism of
      epileptic patients and healthy controls, it is necessary to collect a normative database of
      [18F]-FDG PET images in healthy controls.

      The purpose of this study is (i) collect a normative database of [18F]-FDG PET images in
      healthy adults controls to evaluate rigorously the diagnostic value of multimodal imaging for
      non-invasive localization of the EZ and (ii) to evaluate the test-retest reliability of
      [18F]-FDG PET scanning.
    


Intervention name(s): PET [18F] FDG; Anatomical MRI
Intervention type(s): Other; Other
Intervention description(s): Measurement of carbohydrate metabolism at the individual level. Standardization of the individual imaging data in a standard anatomical space and then calculation of an average image through the group-level controls.; All subjects will benefit from a 3D anatomical MRI to control the normality of their MRI and an automatic segmentation of 73 brain regions by multi-atlas segmentation.
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Physical Activity Intervention to Promote Walking Among Female University Students
Condition: Physical Activity
Study type: Interventional

Summary: 
      This study is a parallel group randomized controlled trial among female university students
      designed to test the effect of a physical activity intervention on daily walking. Both groups
      will receive messages 2-3 times per week via WhatsApp. Intervention group will receive
      orientation and wear a pedometer for the study period. The follow-up duration is 3 months.
    

Detailed description: 
      Background: Sedentary lifestyle is a major risk factor for chronic diseases. The majority of
      Saudi females do not meet a recommended level of physical activity.

      Study Objective: To test the effect of a physical activity intervention on daily walking.

      Study Design: Parallel group randomized controlled design among female university students.

      Methods: Students will be randomly assigned to either the intervention or the control arm.
      WhatsApp groups (2 per arm) will be formed within each study arm for communications. The
      intervention participants will receive a brief (15-minute) orientation on diet, exercise, and
      benefits of keeping a healthy weight; each will be instructed to wear a pedometer every day
      for 12-weeks with a daily step goal of 8,000. They will receive 2-3 health-promotional
      (walking and diet) messages per week via WhatsApp; group interaction is optional. The control
      group participants will receive 2-3 non-health related messages per week. Average daily steps
      will be assessed in all participants at baseline and 3-month follow-up using a 7-day
      pedometer measurement.
    

Intervention name(s): Intervention; Control
Intervention type(s): Behavioral; Other
Intervention description(s): Brief introductory session, pedometer instruction, daily pedometer use, and health messages delivered via WhatsApp 2-3 times per week.; Non-health related messages delivered via WhatsApp 2-3 times per week.
Other intervention name(s): Walking group; Attention Control
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Study of GSK Biologicals' Pandemic Influenza (H1N1) Candidate Vaccine in Children Aged 10 to Less Than 18 Years
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to show that vaccination with a single dose of GSK Biologicals'
      pandemic H1N1 vaccine results in an immune response that meets or exceeds European Medicines
      Agency (EMEA) Committee for Medicinal Products for Human Use (CHMP) guidance criteria for a
      pandemic influenza vaccine.
    


Intervention name(s): GSK Biologicals' Influenza investigational vaccine GSK2340274A; GSK Biologicals' Influenza investigational vaccine GSK2340273A; Placebo (saline)
Intervention type(s): Biological; Biological; Biological
Intervention description(s): One or two doses administered intramuscularly; Two doses intramuscularly; One dose intramuscularly
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: pandemic influenza; Clinical trial; H1N1; children
Ultrasound High BMI Study
Condition: Obesity Complicating Childbirth
Study type: Interventional

Summary: 
      This is a prospective experimental pilot study of full-term non-emergent obese parturients
      whose labor is being managed with epidural anesthesia to determine if neuraxial block
      placement with pre-procedure handheld ultrasound affects time to placement or number of
      needle passes. Approximately 25 patients, presenting for delivery at the University of
      Kentucky HealthCare Obstetrics Department, will be randomized to either the ultrasound or
      palpation group, between study approval and 31 July 2022.
    

Detailed description: 
      Placement of neuraxial blocks is commonly achieved by palpating surface landmarks. This
      somewhat "blind" technique to identify the spinal space becomes more difficult and less
      reliable in obese patients. Ultrasound devices have become common and successful with blocks
      and venous access, both involving mostly soft tissues. Application of conventional ultrasound
      for neuraxial blocks has been limited by its bulkiness, limited imaging for bony structures
      and a long learning curve. A newly developed pocket-size ultrasound addresses these
      limitations by providing real-time pattern recognition for spinal bony structures and 3D
      overlay for recognition of midline spinous process and intervertebral space using an
      automated artificial intelligent algorithm. The hypothesis is that ultrasound guidance will
      reduce time to epidural placement and reduce number of passes in obese patients.
    

Intervention name(s): Neuraxial block placement
Intervention type(s): Procedure
Intervention description(s): The time and ease of administering neuraxial blocks in high BMI patients,for the management of labor and delivery pain, will be assessed.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: High BMI, pregnancy, ultrasound