bioihbjkbjnl/mcl2 huggingface dataset:
A Phase II Study of Carboplatin Plus Irinotecan Versus Irinotecan in Children With Refractory Solid Tumors
Condition: Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      This clinical research study is being conducted to investigate the effectiveness of combining
      carboplatin and irinotecan, versus irinotecan alone, in treating children who have refractory
      solid tumors.
    


Intervention name(s): carboplatin + irinotecan; irinotecan
Intervention type(s): Drug; Drug
Intervention description(s): Solution, IV, Carbopaltin AUC 4 mg/ml.min every 21 days; irinotecan 12 mg/m2/day x 10 days , Minimum of two cycles of chemotherapy projected to be up to 6.; Solution, IV, irinotecan 12 mg/m2/day x 10 days, minimum of two cycles of chemotherapy projected to be up to 6.
Other intervention name(s): Paraplatin
Intervention MeSH terms: Carboplatin; Irinotecan
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: unspecified childhood solid tumor, protocol specific
Sumatriptan Succinate 100 mg Tablets Under Fasting Conditions
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to compare the rate and extent of absorption of sumatriptan
      from a test formulation of Sumatriptan Succinate 100 mg Tablets versus the reference Imitrex®
      100 mg Tablets under fasting conditions.
    

Detailed description: 
      Criteria for Evaluation: FDA Bioequivalence Criteria

      Statistical Methods: FDA bioequivalence statistical methods
    

Intervention name(s): Sumatriptan Succinate; Imitrex®
Intervention type(s): Drug; Drug
Intervention description(s): 100 mg Tablets; 100 mg Tablet
Intervention MeSH terms: Sumatriptan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Bioequivalence; Healthy Subjects
Oral Glutathione Supplementation in Older Healthy Adults and Its Effect on the Number of Healthy Days Experienced During Four Months of Supplementation Compared to Placebo
Condition: Improvement in Immune Cell Function in Elderly Humans
Study type: Interventional

Summary: 
      A randomized, double blind placebo-controlled parallel intervention in adults over the age of
      50 will be performed. Participants will receive a supplement capsule containing placebo
      (Crystalline Cellulose) or 500mg of Setria® Glutathione to eat for 120 days. Glutathione is
      hypothesized to replenish the body's reserves that may be depleted through natural aging
      process, poor diet, or due to the detoxification process for drugs. The primary end point is
      the number of healthy days experienced during the duration of the study. Secondary endpoints
      include cellular and biochemical measures from blood samples taken before and after the
      study.
    

Detailed description: 
      The long term goal of this investigation is to understand how food components improve immune
      function, both in its ability to respond to pathogens and its ability to turn off when the
      response is no longer needed. The goal of this application is to examine mechanisms by which
      glutathione improves immune cells after consumption. The central hypothesis is that
      glutathione improves redox status within the cell, thereby improving cell function and
      increasing the number of healthy days experienced by the participants.

      After obtaining informed consent, human participants will receive 500 mg/day of Setria®
      Glutathione or placebo for 120 days. Peripheral blood mononuclear cells (PBMC), neutrophils
      and serum will be obtained from blood draws before and after the 120 days. A daily diary of
      illness will be kept by each participant and will record any incidence of illness, the number
      of symptoms per incidence, and the number of days in which symptoms are present. This study
      is powered on the basis that over 120 days, the glutathione-supplemented group would
      experience 3% more healthy days compared to the placebo group. The analysis indicated 60
      people per group.
    

Intervention name(s): Setria glutathione supplement; Crystalline Cellulose
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 500 mg/day capsule taken in the morning for 120 days.; 500 mg/day capsule taken in the morning for 120 days.
Other intervention name(s): Setria; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
EndoMaster EASE System for Treatment of Colorectal Lesions
Condition: Colonic Neoplasms
MeSH terms: Colonic Neoplasms
Study type: Interventional

Summary: 
      This is a prospective, single arm study to assess the safety and performance of the
      EndoMaster EASE (Endoluminal Access Surgical Efficacy) System for the treatment of patients
      with colorectal neoplasms.
    

Detailed description: 
      Prospective, single arm study to assess the safety and performance of robotically assisted
      ESD of superficial colorectal lesions, that otherwise cannot be optimally and radically
      removed by snare-based techniques
    

Intervention name(s): EndoMASTER EASE Robotic system for ESD
Intervention type(s): Device
Intervention description(s): EndoMaster EASE System, is a robotic-assisted endoscopy system indicated for endoscopic visualization and therapeutic access to the adult gastrointestinal (GI) tract for endoscopic surgery
Intervention model: Single Group Assignment
Intervention model description: Prospective, Single-Arm Study
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Colonic ESD; Robotic Endoscope
Kinesiotaping and Post-dry Needling Soreness
Condition: Mechanical Neck Pain
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      Application of trigger point dry needling can induce post-dry needling soreness. This is not
      a negative experience, but sometimes some patients want to reduce it as much as possible.
      Different therapeutic strategies targeting to decrease post-dry needling soreness need to be
      investigated. Since Kinesiotaping has been advocated for decreasing tone in the muscle
      tissues, it would be a potential intervention for this objective.
    


Intervention name(s): Kinesiotaping; Placebo
Intervention type(s): Other; Other
Intervention description(s): A Kinesiotaping will be provided over the upper trapezius muscle after the application of dry needling; Individuals will not perform any action after the application of trigger point dry needling
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Ambulatory vs Office BP Management Usual Care for Diagnosing and Managing Hypertension: A Pilot Study
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      The purpose of this study is to compare the effectiveness of ambulatory blood pressure
      monitoring to usual care (blood pressure measurement in the office) in diagnosing and
      managing hypertension.
    

Detailed description: 
      The usual strategy for detecting hypertension-repeated office blood pressure (BP)
      measurements-is inefficient and inaccurate. When paired with ambulatory BP monitoring (ABPM),
      which takes a multitude of measurements over 24 hours, it is clear that office BP
      measurements may convey a falsely positive diagnosis known as white-coat hypertension. What
      is less well-known is that office BP measurements may also convey a falsely negative
      diagnosis termed masked hypertension (MH). That is, office BP may measure as normal, yet
      24-hour ambulatory measurements show elevated BP. People with MH have cardiovascular risk
      that is similar to that of people with diagnosed hypertension, yet MH goes unrecognized, and
      therefore, untreated. Ultimately, identifying the best strategy for accurately detecting
      hypertension is vital to improving overall BP control and reducing cardiovascular events.
      Without a feasible ABPM strategy, MH will continue to go unrecognized and untreated.

      Participants enrolled in the study will be randomized to either the usual care group or the
      ABPM-guided group. All participants will have a baseline ABPM. ABPM will be used to make a
      diagnosis and determine anti-hypertensive treatment in the ABPM-guided group only.
      Participants in the ABPM-guided group will have a follow-up ABPM in 2 months. All
      participants will have a final ABPM 4 months after enrollment.
    

Intervention name(s): Amlodipine; Chlorthalidone; Losartan
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Amlodipine 5 mg or 10 mg; Chlorthalidone 12.5 mg or 25 mg; Losartan 50 mg or 100 mg
Other intervention name(s): Norvasc; Thalitone; Cozaar
Intervention MeSH terms: Losartan; Amlodipine; Chlorthalidone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Hypertension; Blood Pressure; Ambulatory Blood Pressure Monitoring
Pharmacologic Impact on Sedation Assessments
Condition: Pediatric Acute Lung Injury
MeSH terms: Lung Injury; Acute Lung Injury
Study type: Observational

Summary: 
      PISA is an ancillary study to the NIH funded clinical RESTORE Trial (U01 HL086622). This
      study will provide data that may allow for improved dosing recommendations in this critically
      ill population of children.
    

Detailed description: 
      PISA is an ancillary study to the NIH funded clinical RESTORE Trial (U01 HL086622). This
      project will use sophisticated modeling and simulation techniques to evaluate the impact of
      genetics and other variables such as degree of illness, age, weight and organ dysfunction on
      the pharmacokinetics and pharmacodynamics of morphine and midazolam in children who are
      mechanically ventilated for respiratory failure, and require sedation. This proposed work
      will allow the design of a pharmacologic model that can be used to individualize therapy in
      children requiring mechanical ventilation with the goal of optimizing sedation while
      minimizing the duration of mechanical ventilation. This study will provide data that may
      allow for improved dosing recommendations in this critically ill population of children.
    

Intervention name(s): Pharmacokinetic Sampling and pharmacogenetic analysis
Intervention type(s): Other
Intervention description(s): Pharmacogenetic and pharmacokinetic samples will be obtained from a peripheral catheter, central catheter, or venipuncture coordinated with scheduled phlebotomies. Pharmacokinetic and pharmacogenetic analyses will be performed. Pharmacodynamic data will be collected.
Other intervention name(s): Pharmacokinetic Sampling; pharmacogenetic Sampling
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Subjects must be enrolled in the parent study RESTORE, be at least 10kg, and be receiving
        either morphine and/or midazolam continuous infusions.
      
Biospecimen description: 
      The primary evaluation will be the assessment of morphine/midazolam pharmacokinetics (PK) and
      pharmacodynamics (PD). Data from all fully evaluable subjects will be included in the
      analysis. Analyses will be model based.
    
Keywords: sedated; intubated; mechanically ventilated; pediatric; lung injury
Efficacy of Plaque Removal of a Novel Brushing Device
Condition: Dental Plaque
MeSH terms: Dental Plaque
Study type: Interventional

Summary: 
      The purpose of this research study is to compare how a novel, automated mouthpiece-based
      toothbrushing device removes dental plaque compared to a manual toothbrush.
    

Detailed description: 
      Plaque is one of the main etiological factors in dental decay and the principal etiological
      factor for periodontal diseases. Although toothbrushes have greatly evolved, dexterity is
      still the key component to an efficient cleaning routine. The primary goal is to examine 60
      participants to determine the efficacy of a new powered teeth cleaning device designed to
      bypass the variability of individual dexterity compared with manual toothbrushing.

      This is a single-blind, randomized controlled trial. Sixty pediatric patients will be
      recruited for the study and randomized into treatment and control groups, subdivided into
      primary (20), mixed (20), and permanent dentition (20). Participants will be asked to abstain
      from brushing, flossing, gum or mouthwash use for 24 hours prior to the study visit. Plaque
      will be assessed using the Turesky Modification of the Quigley-Hein Plaque Index before and
      after a one-time brushing with the assigned study device. A soft tissue assessment will be
      conducted and intraoral photos taken pre- and post-brushing.
    

Intervention name(s): Automated mouthpiece-based toothbrush; Manual toothbrush
Intervention type(s): Device; Device
Intervention description(s): One-time use during study visit.; One-time use during study visit.
Other intervention name(s): Novel toothbrushing device
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Single-blind, parallel group, randomized controlled clinical trial
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Gingivitis; toothbrushing; oral hygiene; biofilm
Effects of Moringa Oleifera on hsCRP and Hgba1c Level of Patients in Ospital ng Maynila Medical Center Diabetic Clinic
Condition: Diabetes
Study type: Interventional
Phase: Phase 1

Summary: 
      Current evidence supports a central role of inflammation in the pathogenesis of
      atherosclerosis and diabetes [57-60]. Diabetes Mellitus type 2 is an inflammatory
      atherothrombotic condition associated with high prevalence of thrombotic cardiovascular
      disease. In patient with DM type 2, this inflammation is reflected by elevated plasma levels
      of several biomarkers of inflammation such as C-reactive protein (CRP) [51-55]. HsCRP is
      considered as a strong predictive of cardiovascular risks and death [53, 61-72]. Besides its
      predictive role in determining cardiovascular risk, there is some evidence that CRP may
      represent an active participant in atherogenesis [54]. CRP is expressed in human
      atherosclerotic plaques and both vascular cells and monocytes/macrophages appear to represent
      a significant source of CRP in the inflammatory vessel wall [54].

      Among the DM risk factors (like hypertension, atherogenic dyslipidemia, insulin resistance,
      impaired fibrinolysis, inflammatory profile), definitely, inflammation is the neglected one.

      Moringa oleifera has been suggested to exert anti-inflammatory effects [42][43][45] and
      hypoglycemic property [80]. As with many reports of the nutritional or medicinal value of a
      natural product, there are an alarming number of purveyors of "healthful" food who are now
      promoting M. oleifera as a panacea. While much of this recent enthusiasm indeed appears to be
      justified, it is critical to separate scientific evidence from anecdote.

      Herein, the investigators will investigate the effects of Moringa oleifera leaves
      supplementation on levels of inflammatory marker specifically hsCRP, hgbA1c level and
      clinical outocome in diabetic patients through a cohort study.
    

Detailed description: 
      We performed a prospective cohort study of adult diabetics who were given 12-weeks
      supplementation of Moringa oleifera. Plasma hsCRP and serum HgbA1c were compared before and
      after treatment with M. oleifera.
    

Intervention name(s): Moringa oleifera
Intervention type(s): Dietary Supplement
Intervention description(s): 12 weeks supplementation
Other intervention name(s): Malungay
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: hscrp; hgba1c; diabetes mellitus
Effect of Reduction of Inflammatory Status on Glucose Metabolism in Overweight Men
Condition: Overweight; Obesity; Inflammation
MeSH terms: Overweight; Inflammation
Study type: Interventional

Summary: 
      Overweight increases the risk to develop chronic diseases including type-2 diabetes and
      cardiovascular disease. The low-grade inflammatory status often seen in overweight subjects
      is thought to play an important role in disease development.

      The purpose of this study is to determine the role of inflammation on glucose metabolism and
      insulin resistance. In this study the effect of the anti-inflammatory treatment diclofenac on
      markers of inflammation and on parameters of glucose metabolism will be studied.
    


Intervention name(s): Diclofenac
Intervention type(s): Drug
Intervention MeSH terms: Diclofenac
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Safety Study of the Ventricular Partitioning Device (VPD) Implant System in Heart Failure Patients
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 1

Summary: 
      The CardioKinetix Ventricular Partitioning Device (VPD) is intended to isolate the
      malfunctioning portion of the left ventricle in patients with symptoms of heart failure due
      to ischemic heart disease. By isolating the malfunctioning portion of the left ventricle, it
      is hypothesized that the left ventricle will pump more effectively.
    


Intervention name(s): VPD Implant System
Intervention type(s): Device
Intervention description(s): Percutaneous introduction using standard catheterization techniques of the VPD Implant.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Heart failure; percutaneous; interventional cardiology; apical remodeling; LV dilatation; akinesis; dyskinesis
18611 - Sun Protection Factor Assay
Condition: Sunscreening Agents
Study type: Interventional

Summary: 
      To evaluate the Sun Protection Factor efficacy on human skin.
    


Intervention name(s): BAY 987517
Intervention type(s): Drug
Intervention description(s): Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application (Formulation number V26-160)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Sevoflurane and Ketamine on QT in Electroconvulsive Therapy
Condition: Major Depression; Electroconvulsive Therapy
MeSH terms: Depressive Disorder, Major
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study was to evaluate the effect of sevoflurane or ketamine on the QTc and
      Tp-e interval during in patients with major depression.
    

Detailed description: 
      Patients enrolled in the study are randomly allocated by computer-generated random numbers to
      receive either sevoflurane or ketamine for their initial ECT session. They subsequently
      receive an alternative study drug in their next session, continuing to alternate between
      drugs at each session until the sixth session. In group S, sevoflurane are initiated at %8
      sevoflurane for anesthesia induction and maintained at 2% to %4 until the electrical stimulus
      is delivered, In group K, ketamine are given to 1mg/kg ıv bolus.

      Electrical stimulus is delivered via bilateral frontotemporal electrodes.The mean arterial
      pressure (MAP), HR, and ECG are recorded before anesthetic induction (T1), after anesthetic
      induction (T2) and at 0, 1, 3, 10 min after the seizure ended (T3, T4, T5 and T6,
      respectively).The QT interval and Tp-e interval are measured by one author, who was unaware
      of group allocation.
    

Intervention name(s): Sevoflurane; Ketamine
Intervention type(s): Drug; Drug
Intervention description(s): sevoflurane was initiated at %8 sevoflurane for anesthesia induction and maintained at 2% to %4 until the electrical stimulus was delivered; ketamine was given to 1mg/kg ıv bolus
Other intervention name(s): Volatile agent; Intravenous anesthetic agent
Intervention MeSH terms: Ketamine; Anesthetics; Sevoflurane; Anesthetics, Intravenous
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: sevoflurane; ketamine; QT interval
Early Mobilization of Operatively Stabilized Distal Radius Fractures - a Randomized Controlled Trail
Condition: Closed Fracture of Lower End of Radius and Ulna
MeSH terms: Fractures, Bone; Radius Fractures; Wrist Fractures; Fractures, Closed
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate if an early mobilization after distal radius
      fractures treated by surgery leads to an better functional outcome then immobilization after
      surgery for 5 weeks in a cast
    

Detailed description: 
      All patients with a distal radius fracture treated by surgery (palmar angle stable plate)
      will be included in this study and randomised into two groups according the CONSORT
      Guidelines of Prospective Randomised Trails. One group ("early mobilisation") receive a
      removable plastic cast for one week and are allowed to move the wrist directly postoperative.

      The other group ("control group") received a non removable cast for 5 weeks. Both groups
      underwent physiotherapy two times a week. The control group was only allowed to move the
      closed-by joints.

      In the 6., 9., 12. postoperative week, a half and one year after the operation the patients
      underwent range of motion (ROM), grip strength measurement and pain according to the visual
      analogue scale (VAS). Hand function will be analysed according the PRWE (Patient-Rated Wrist
      Evaluation) Score, DASH (Disabilities of the Arm, Shoulder and Hand) Score and Mayo Wrist
      Score.

        -  Inclusion criteria:

             -  Age ≥ 18 and ≤ 75 years

             -  A2 - C3 distal radius fracture

             -  no acute or older injury that influences hand function

             -  operative stabilized by palmar angle stable plate

        -  Exclusion criteria:

             -  Age ≥ 76 years

             -  Age < 18 years

             -  C3.3 radius fracture

             -  acute or preexisting injures that influences hand function

             -  pregnancy

             -  neurologic disorders

             -  incapacitated people
    

Intervention name(s): Questionnaire; X- Ray; Grip Strength; VAS Score; Range of Motion measurement
Intervention type(s): Other; Radiation; Other; Other; Other
Intervention description(s): DASH Score, PRWE Score, Mayo Wrist Score; X-ray exposures in two planes 6., 9., 12. postoperative week, half and one year after surgery; Grip strength measurement; Measurement pain according to the visual analogue scale (VAS); Angle measurement of the active range of motion in the wrist
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: distal radius fractures; early mobilization; postoperative treatment; outcome