bioihbjkbjnl/mcl2 huggingface dataset:
Neuromuscular Electrical Therapy in Venous Ulcers
Condition: Chronic Venous Insufficiency
MeSH terms: Venous Insufficiency; Varicose Ulcer
Study type: Interventional
Phase: Phase 4

Summary: 
      The use of neuromuscular electrical stimulation in the treatment of venous ulcers with
      difficulty of repair could be an alternative therapeutic favoring devitalized tissues and
      hence the pain.

      The aim of this study is to evaluate the effect of neuromuscular electrical stimulation on
      pain and area of venous ulcers in patients with venous insufficiency.
    

Detailed description: 
      The aim was to evaluate the effect of neuromuscular electrical stimulation on pain and area
      of venous ulcers in patients with venous insufficiency. In a simple-blind controlled clinical
      study, 20 subjects with venous ulcers with age over 50 years will be divided in two
      groups:neuromuscular electrical stimulation(n=10) and control group (n=10). Pain (by Visual
      Analogue Scale) and the ulcer area (by planimetry on graph paper and the software ImageJ ®)
      were measured.
    

Intervention name(s): neuromuscular electrical stimulation
Intervention type(s): Other
Intervention description(s): The application technique used will be bipolar, with electrodes of the type metal-tipped pen. The electrodes will be placed at the outer edges of the ulcer, on opposite sides of the same and the estimated time of 1 minute at each point. All the edge of the ulcer will be bypassed, thereby separating the injections every 1 cm, returning to the starting point at the end of the application. To ensure that the entire edge of the ulcer to receive the stimulation, the end points of the application, the application will be made for another minute sliding the pen around the whole edge. Thus the application time will be directly proportional to the ulcer area. The subjects will be received 10 applications, three times a week for a period of 4 weeks.
Other intervention name(s): intervention group
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Varicose ulcer; wound healing; electrical stimulation
Efficacy of Serratus Anterior Plane Block Mastectomy
Condition: Postoperative Pain; Postoperative Complications
MeSH terms: Postoperative Complications
Study type: Interventional

Summary: 
      Breast cancer is the main common cancer among females. . Inadequate control of pain may later
      develop into chronic pain syndrome (paraesthesias, phantom breast pain, and
      intercostobrachial neuralgia) in 25-40% of the patients .
    

Detailed description: 
      The aim of this study is to compare the efficacy of ultrasound-guided serratus anterior plane
      block with bupivacaine/ magnesium versus bupivacaine/ nalbuphine in breast cancer surgery.

      Patients and methods nclusion criteria:

      -ASA I and II female patients, age 25-60 undergoing breast cancer surgery

      Exclusion criteria:

        -  Patient refusal

        -  Contraindications for regional blocks (eg. Infection at the injection site,
           coagulopathy)

        -  Allergy to the drugs used in the study

        -  Chronic pain therapy,

        -  BMI more than 30 kg/m2
    

Intervention name(s): serratus anterior plan block
Intervention type(s): Procedure
Intervention description(s): serratus anterior plan block
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Other
Nonradiation-to-endoscopist Endoscopic Retrograde Cholangiopancreatography in Patients With Complexity Level I/II
Condition: Endoscopic Retrograde Cholangiopancreatography , Gallstone
MeSH terms: Gallstones; Cholelithiasis; Cholecystolithiasis
Study type: Observational

Summary: 
      Radiation exposure may put endoscopists at risk when performing endoscopic retrograde
      cholangiopancreatography. Although non-radiation endoscopic retrograde
      cholangiopancreatography was reported in pregnant women in previous reports, it remains
      unclear whether endoscopic retrograde cholangiopancreatography is also effective and safe
      when endoscopists were not expose to radiation. This study was to evaluate the effectiveness
      and safety of nonradiation-to-endoscopist endoscopic retrograde cholangiopancreatography in
      patients with complexity level I/II.
    


Intervention name(s): nonradiation-to-endoscopist endoscopic retrograde cholangiopancreatography; standard endoscopic retrograde cholangiopancreatography
Intervention type(s): Radiation; Radiation
Intervention description(s): All patients received magnetic resonance cholangiopancreatography before the procedure. Characteristics of lesions (e.g. common bile duct stones, stenosis) in detail was identified. During the procedure, the endoscopist was not exposed to radiation. If fluoroscopy was needed, after contrast injection (sometimes not necessary), the endoscopist went outside of the operation room and observed the X-ray image by remote control of the fluoroscopy machine.; Patients received standard endoscopic retrograde cholangiopancreatography. Fluoroscopy was normally used when necessary.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        18-90 years old, patients undergoing endoscopic retrograde cholangiopancreatography
      
Keywords: ERCP; nonradiation-to-endoscopist; gallstones
Efficacy and Safety of Activated Recombinant Human Factor VII in Severely Injured Trauma Patients
Condition: Acquired Bleeding Disorder; Trauma
MeSH terms: Hemostatic Disorders; Blood Coagulation Disorders; Hemorrhage; Wounds and Injuries
Study type: Interventional
Phase: Phase 2

Summary: 
      This trial is conducted in Africa, Asia, Europe, Oceania and North America. The aim of this
      trial is to evaluate the efficacy of activated recombinant human factor VII given in
      conjunction with standard therapy in the treatment of massive bleeding in subjects with
      severe blunt and/or penetrating trauma injury.
    


Intervention name(s): activated recombinant human factor VII; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Standard therapy in conjunction with three single doses of rFVIIa administered over a 3 hour period. Administered once the subject has received 8 units of PRBC; Standard therapy in conjunction with three single doses of placebo administered over a 3 hour period. Administered once the subject has received 8 units of PRBC
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Improving Outcomes In Diabetic Patients During CABG Surgery By Optimizing Glycemic Control
Condition: Glycemic Control
Study type: Interventional
Phase: Phase 1

Summary: 
      This study seeks to determine whether varying the dose of insulin and glucose in diabetic
      patients during coronary bypass surgery will improve outcomes in these patients.
    

Detailed description: 
      Our previous study has shown that maintaining serum glucose between 120-180mg/dl in the
      perioperative period during CABG surgery in diabetic patients improves outcomes. The purpose
      of this trial is: (1) to determine whether outcomes can be improved by altering the content
      of glucose or insulin in these solutions (2)to determine the effect of these solutions and
      glycemic control on the inflammatory response of arterial and venous conduits used during
      surgery, (3) to determine whether the beneficial effects of improved glycemic control can be
      correlated with changes in the inflammatory response.
    

Intervention name(s): A IV Insulin drip; B Low Dose GIK; C High Dose GIK
Intervention type(s): Drug; Drug; Drug
Intervention description(s): These patients will receive 100units of insulin in 100ml of saline intravenously to keep blood glucose between 120-180mg/dl.; These patients will receive D5W+80unitsInsulin+40mEqKCL IV to keep blood glucose between 120-180mg/dl; This group will receive D20W+160units IV insulin to keep blood sugar between 120-180mg/dl
Intervention MeSH terms: Insulin
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Diabetes
Phase 1 Drug Interaction Study of the Effect of Apixaban on the PK of Digoxin in Healthy Subjects
Condition: N/A - Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the effects of Apixaban on the Pharmacokinetics (PK)
      of multiple-dose Digoxin in healthy subjects.
    


Intervention name(s): Apixaban; Digoxin
Intervention type(s): Drug; Drug
Intervention MeSH terms: Digoxin; Apixaban
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Whole Body Protein Metabolism of a Whey/EAA Supplement Using Continuous Oral Stable Isotopes
Condition: Healthy
Study type: Interventional

Summary: 
      To evaluate the validity of a continuous oral sip-feeding method of stable isotope tracer for
      the evaluation of whole-body protein metabolism in response to two different doses of an
      EAA/whey protein supplement (Low=6.3g and High=12.6g). Results will be compared to those
      previously determined by constant infusion with the same EAA/whey supplement.
    

Detailed description: 
      This will be a double-blinded, randomized, crossover pilot study to evaluate the validity of
      a continuous oral sip-feeding of stable isotope tracer method for the evaluation of
      whole-body protein metabolism. This method will be evaluated using two different amounts of
      an essential amino acid (EAA) + whey protein supplement on up to six younger, healthy
      subjects. Stable isotope preparations will be continuously consumed by subjects throughout
      visits 2 and 3 to enable whole body protein metabolism to be measured.
    

Intervention name(s): Oral amino acid tracer
Intervention type(s): Other
Intervention description(s): Whole body protein metabolism response to a dose of the supplement will be measured using a continuous oral sip-feeding (every 10 minutes) method of stable isotope tracer.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: double-blinded, randomized, crossover pilot study
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: Stable Isotopes; Validation; Whole-body protein metabolism
Study Evaluating the Long-Term Safety and Efficacy of ABX464 in Patients With Moderate to Severe Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2

Summary: 
      A phase 2a open-label study to evaluate the long-term safety and efficacy of ABX464 50mg as
      maintenance therapy in patients with moderate to severe rheumatoid arthritis.
    

Detailed description: 
      This Phase 2a open-label study aims at investigating the long-term safety and efficacy of an
      oral dose of ABX464 in patients who have been previously enrolled in the ABX464-301 clinical
      study and who are willing to continue their treatment.

      All patients will receive ABX464 given at 50mg o.d. irrespectively of their previous
      treatment received in the ABX464-301 study (i.e. ABX464 or Placebo).

      The enrolment in this follow-up study will be based on the willingness of the subject to
      carry on his/her participation and also based on investigator's judgement.

      Patients will be treated with ABX464 for a period of 52 weeks. If they achieve a clinical
      response on Week 52 (defined as DAS28-CRP ≤ 2,6 for anti-TNFα naïve patients or DAS-28-CRP ≤
      3,2 for patients previously treated by anti-TNFα), they will be eligible to continue
      treatment for up to 104 weeks.Patients will be followed up at week , week 2 and then, on a
      monthly basis the first year (up to W52), and quaterly the second year (up to W104).
    

Intervention name(s): ABX464
Intervention type(s): Drug
Intervention description(s): All subjects will receive ABX464 administered at 50 mg o.d for an overall period of 2 years (104 weeks).
Intervention model: Single Group Assignment
Intervention model description: Open-label, follow-up study
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: moderate to severe Rheumatoid Arthritis
Height Measurement in Critically Ill Children
Condition: Critically Ill Child; Nutritional Status; Height; Length
MeSH terms: Critical Illness
Study type: Observational

Summary: 
      Height/length has to be assessed accurately in critically ill children, as its value is
      required to assess nutritional status, to calculate nutritional requirements, to calculate
      body surface area (involved in drug prescriptions), and to assess pulmonary function.

      The WHO has standardized practices to perform height/length measurements, but this gold
      standard is not applicable in critically ill children (who cannot stand and are equipped with
      catheters, tubes and various devices). It is not accurate to rely on previous measurements as
      children are continuously growing. No height/length measurement tool or method has been
      validated so far in this population, neither any estimation nor extrapolation methods.

      The investigators aim to compare the WHO gold standard for height/length measurement to a
      list of other methods, validated in other children populations and currently used in the
      pediatric setting. We intend to compare each of them to the gold standard. The secondary
      objectives are to describe each height/length extrapolation or estimation method and to
      estimate the practical use of each method for critically ill children.

      A prospective observational study is planned. 140 critically ill children admitted to
      pediatric intensive care unit (PICU) will be recruited.

      Body segments (ulna, tibia, knee-heel, arm span) will be measured and length/height
      extrapolated from formulas used in different populations. Previous length/height measurements
      will be collected to draw growth curves and extrapolate actual length/height. Parents will be
      asked how tall their child is.

      After PICU discharge, while the child meets WHO measurement standards, accurate length/height
      will be measured and compared to the results of the above mentioned techniques.

      Comparison will be made in-between these results.
    


Intervention name(s): critically ill children
Intervention type(s): Other
Intervention description(s): Compare a series of measurement or size estimation techniques to the WHO standard to identify the most reliable method (s) of pediatric resuscitation.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        One tertiary care university children hospital Pediatric intensive care unit
A Study Evaluating the Effect of Esomeprazole on SYN-004 Degradation of Ceftriaxone In Adults With an Ileostomy
Condition: Healthy Volunteers With Ileostomy
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      A Phase 1b/2a, Multi-Center, Open-Label, 2-Period, Fixed-Sequence Study Evaluating the Effect
      of Esomeprazole on SYN-004 Degradation of Ceftriaxone In Healthy Adult Subjects with a
      Functioning Ileostomy
    

Detailed description: 
      This is a Phase 1b/2a, randomized, multi-center, open-label study. Twenty otherwise healthy
      subjects with functioning ileostomies who are between the ages of 18 and 80 years, inclusive,
      will be enrolled. The entire duration of the study may be up to 63 days (from Screening to
      the end-of-study [EOS] visit).
    

Intervention name(s): SYN-004; Esomeprazole; Ceftriaxone
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Ceftriaxone; Esomeprazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
To Evaluate the Safety, Tolerability, and Pharmacokinetics Profiles of TG-1000 in Healthy Volunteers, and the Food Effect on Pharmacokinetics of Single Oral Dose of TG-1000 in Healthy Volunteers.
Condition: Healthy Chinese Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics
      profiles of TG-1000 in healthy volunteers, and to evaluate the food effect on
      pharmacokinetics of single oral dose of TG-1000 in healthy volunteers.
    

Detailed description: 
      This is a phase 1, single-center, randomized, double-blind, placebo-controlled, single-dose
      escalation study to evaluate the safety, tolerability, and pharmacokinetics profiles of
      TG-1000 in healthy volunteers, and to evaluate the food effect on pharmacokinetics of single
      oral dose of TG-1000 in healthy volunteers. The study will be divided into two parts.

      Part A is designed as randomized, double-blind, placebo-controlled, sequential, single
      ascending oral dose to evaluate the safety, tolerability, and PK profiles of TG-1000 in
      healthy volunteers.

      Part B is designed as randomized, open-label, two treatment (fasted vs. fed), two-period,
      two-sequence crossover to compare the effects of food on the Pharmacokinetic (PK) of single
      oral dose of TG-1000 in healthy subjects.
    

Intervention name(s): TG-1000; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Subjects will receive one single oral dose of TG-1000 on day 1 following protocol requirements.; Subjects will receive one single oral dose of placebo on day 1 following protocol requirements.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: single-center, randomized, double-blind, placebo-controlled, single-dose
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Evaluation of a Smartphone-based Screening Tool (Picterus Jaundice Pro) for Neonatal Jaundice in Dark Skin Newborns
Condition: Jaundice, Neonatal
MeSH terms: Jaundice, Neonatal; Jaundice
Study type: Interventional

Summary: 
      A cross-sectional study at the Södersjukehuset facility (Stockholm, Sweden) collect data of
      newborns from a population with Neomar scale type 4 to adjust the algorithm of Picterus JP
    

Detailed description: 
      To adjust Picterus JP to work in newborns with more pigmented skin, the investigators will
      collect a data set at Sachsska barnsjukhuset Södersjukhuset, Stockholm Sweden from 150
      newborns with dark skins using Picterus JP, TcB, skin measurements from a spectrometer,
      visual assessment, and total serum bilirubin (TSB) levels. As a control, newborns with Neomar
      scale 1-3 will be included.
    

Intervention name(s): Picterus Jaundice Pro
Intervention type(s): Device
Intervention description(s): Use Picterus Jaundice Pro, a smartphone app that is used to take photo of the newborns skin, where the Picterus calibration card is place.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
Evaluation of RC28-E Injection in Wet Age-related Macular Degeneration
Condition: Wet Age-Related Macular Degeneration
MeSH terms: Macular Degeneration
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a non-randomized, open-label, multicenter, 48-week study to investigate the efficacy,
      safety and pharmacokinetics of RC28-E injection in the treatment of patients with wet
      age-related macular degeneration by multiple administration.
    


Intervention name(s): intravitreal injection of RC28-E 0.5mg; intravitreal injection of RC28-E 1.0mg; intravitreal injection of RC28-E2.0mg
Intervention type(s): Biological; Biological; Biological
Intervention description(s): The patient received one treatment of RC28-E 0.5mg in the test group; The patient received one treatment of RC28-E 1.0mg in the test group; The patient received one treatment of RC28-E 2.0mg in the test group
Intervention MeSH terms: RC28-E protein
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Exenatide Plus Metformin vs. Insulin Aspart Plus Metformin on Glycemic Control and Hypoglycemia in Patients With Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemia
Study type: Interventional
Phase: Phase 3

Summary: 
      This study in Germany is designed to compare the effects of twice-daily exenatide plus
      metformin and twice-daily premixed human insulin aspart plus metformin with respect to
      glycemic control, as measured by HbA1c, combined with the percentage of patients with at
      least one treatment-emergent hypoglycemic episode. Patients will be treated with study
      therapy for approximately 26 weeks.
    


Intervention name(s): exenatide twice daily (BID); premixed insulin aspart twice daily (BID)
Intervention type(s): Drug; Drug
Intervention description(s): subcutaneous injection (5 mcg or 10 mcg), twice a day; subcutaneous injection (titrated appropriately), twice a day
Other intervention name(s): Byetta
Intervention MeSH terms: Insulin Aspart; Exenatide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: diabetes; exenatide; Byetta; Amylin; Lilly
Improving Antiretroviral Medication Adherence Among HIV-infected Youth: Phase I
Condition: HIV Infection
MeSH terms: HIV Infections
Study type: Observational

Summary: 
      HIV is increasing among adolescents and young adults in the US. Antiretroviral medications,
      when taken correctly (≥90% of prescribed doses taken), can vastly improve life expectancy.
      However, adherence among HIV-infected young people is suboptimal, and few interventions are
      available to help adolescents adhere to treatment.

      The first phase of the study is an intervention development phase, which includes conducting
      interviews with 40 HIV-infected youth for input on the adaptation of the approach. The
      information obtained from the qualitative interviews is used to adapt the Life-Steps
      intervention (designed by our group for HIV-infected adults) to be responsive to the needs of
      HIV-infected adolescents, with acceptability of topics and content, and feasibility of
      intervention delivery to be tested in an open pilot trial.
    

Detailed description: 
      This phase of the protocol focuses on setting up the infrastructure necessary for conducting
      the study, including hiring and training activities with study staff. This time will be spent
      conducting interviews and using these data to inform the development of the intervention
      protocol and adaptation of all Life-Steps intervention materials, including study assessment
      instruments, for HIV-infected youth.

      The interview is a one-time event and will last for 1.5-2 hours. It has two components: a
      quantitative assessment and a qualitative discussion. After all participants have completed
      the informed consent and assent (if under the age of 18) processes, the research staff will
      administer a brief quantitative assessment that will ask questions related to demographics,
      medication adherence, sexual risk, substance use, and psychosocial condition. The second part
      of the interview will be an open discussion. The interviews will be conducted by a trained
      member of the research staff. The interviews will be informed by a pre-determined qualitative
      topic guide.
    

Observational model: Cohort
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        HIV-infected youth between the ages of 13 and 24
      
Keywords: hiv; antiretroviral; adherence; adolescent