bioihbjkbjnl/mcl2 huggingface dataset:
Combined Non-invasive Coronary Angiography and Myocardial Perfusion Imaging Using 320 Detector Computed Tomography
Condition: Arterial Occlusive Diseases; Coronary Disease; Heart Diseases; Myocardial Ischemia; Vascular Diseases; Arteriosclerosis; Ischemia; Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Heart Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Ischemia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the diagnostic accuracy of multi-detector computed
      tomography using 320 detectors for identifying the combination of coronary artery stenosis ≥
      50% and a corresponding myocardium perfusion defect in a patient with suspected coronary
      artery disease compared with conventional coronary angiography and single photon emission
      computed tomography myocardium perfusion imaging.
    

Detailed description: 
      The Combined Coronary angiography and myocardial perfusion imaging using 320 detectors
      computed tomography (CORE-320) was designed as a prospective, multi-center, international,
      blinded study designed to evaluate the diagnostic accuracy of multi-detector computed
      tomography using 320 detectors for identifying coronary artery luminal stenosis and
      corresponding myocardium perfusion defects in patients with suspected coronary artery
      disease. The primary analysis will be a comparison of the diagnostic capability of the
      combination of quantitative 320-MDCT angiography and quantitative perfusion imaging to the
      combination of conventional coronary angiography and SPECT myocardial perfusion imaging at
      the patient level. A positive patient will be defined as having at least one vessel with a ≥
      50% diameter stenosis defined by quantitative coronary angiography and a corresponding
      positive SPECT territorial myocardial perfusion defect.
    

Intervention name(s): 320 Volume Detector Computed Tomography; Other: Multidetector Computed Tomography - 320 detectors
Intervention type(s): Procedure; Other
Intervention description(s): Single Arm Study. All patients undergo Volume (Multidetector) CT.; Multidetector computed tomography angiography
Other intervention name(s): Aquilion ONE CT scanner
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: Coronary Artery Disease; Computed Tomography; Myoperfusion; Angiography; SPECT
Insulin Therapy in the Hospital Comparing Two Protocols
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine if by using insulin analog (Glargine and lispro
      insulin) with an insulin pen the investigators are able to obtain a higher rate of correct
      timing of insulin and food administration as when compared to the usual therapy (insulin NPH
      and regular) with syringes.
    


Intervention name(s): Glargine insulin; NPH insulin and regular insulin; lispro insulin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): The study group will receive Insulin Glargine as basal insulin. The protocol for initial insulin dose and subsequent dose adjustment has been developed by the "Inpatient Diabetes Advisory Group" and is detailed in appendix A. The patient will receive information regarding diabetes treatments, appropriate diet and diabetic self management which will be provided by the nursing and nutritional staff.; The active control group will receive twice daily NPH insulin as basal insulin and bolus (prandial) insulin as regular insulin to be administered 30 minutes before meals. The administration of basal (prandial) regular insulin and food will be done as the current usual care on the hospital ward. The protocol for initial insulin dose and subsequent dose adjustment has been developed by the "Inpatient Diabetes Advisory Group" and is detailed in appendix B. The patient will receive information regarding diabetes treatments, appropriate diet and diabetic self management which will be provided by the nursing and nutritional staff.; Bolus (prandial) insulin as lispro insulin (choice between pens or vials will be made). The administration of bolus (prandial) insulin pen or syringe will be delivered concurrently with the food tray (the concept of "insulin pen/syringe on the food tray") by the nursing staff that together with hospital food services identifies the food tray for the patients in the study group. The protocol for initial insulin dose and subsequent dose adjustment has been developed by the "Inpatient Diabetes Advisory Group" and is detailed in appendix A. The patient will receive information regarding diabetes treatments, appropriate diet and diabetic self management which will be provided by the nursing and nutritional staff.
Other intervention name(s): Lantus insulin
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine; Insulin, Isophane; Isophane Insulin, Human; Isophane insulin, beef; Insulin Lispro
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetes; Inpatient; Insulin; Insulin pen
A Study in Healthy Male Subjects Designed to Assess the Mass Balance Recovery and Pharmacokinetics of 14C TZP-101
Condition: Postoperative Ileus
Study type: Interventional
Phase: Phase 1

Summary: 
      A study to investigate the mass balance recovery and pharmacokinetics of 14C TZP-101.
    


Intervention name(s): TZP-101
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Active Reminders and Motivational Techniques on Oral Hygiene and Gingival Health in Orthodontic Patients
Condition: Oral Hygiene; White Spot Lesion; Gingivitis
MeSH terms: Gingivitis
Study type: Interventional

Summary: 
      This study will compare the use of text message reminders versus multiple in-person sessions
      of oral hygiene instructions and motivation on improving oral hygiene measurements.
    

Detailed description: 
      Orthodontic treatment (i.e. braces) makes it hard to keep good oral hygiene. The purpose of
      this research study is to compare the use of text message reminders versus multiple in-person
      sessions of oral hygiene instructions and motivation on improving oral hygiene measurements.
      Participation in this study will last up to 6 months and will consist of 4 study visits to
      the VCU Orthodontic clinic which are also regular visits for treatment. Measurements to
      assess participant's oral health will be taken during these visits. Participants will be
      randomly assigned to 1 of 4 groups which may include receiving different types of text
      messages, repeated in-person oral hygiene instructions, or both, or neither.
    

Intervention name(s): Oral hygiene instructions
Intervention type(s): Behavioral
Intervention description(s): Oral hygiene instructions and motivation
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Association Between Heat Pain Detection Threshold and Area of Secondary Hyperalgesia
Condition: Healthy
MeSH terms: Hyperalgesia
Study type: Interventional

Summary: 
      The purpose of this prospective study is to investigate how close Heat Pain Detection
      Threshold is associated with the area of secondary hyperalgesia, elicited by the clinical
      pain model Brief Thermal Sensitization.

      Furthermore we wish to investigate how close the clinical pain model: Pain during 1 min.
      heating of the skin (45 degrees celsius), and the psychological tests, Pain Catastrophizing
      Scale and Hospital Anxiety and Depression Scale are associated with the area of secondary
      hyperalgesia, elicited by the clinical pain model Brief Thermal Sensitization.
    

Detailed description: 
      The study participants will be tested with 3 types of clinical pain models on two separate
      identical study days. A minimum of 7 days will separate the two study days, thus, the minimum
      length of the study is 7 days, but can be higher.

      The 3 types of pain conditioning consist of 1) Brief thermal sensitisation (BTS), 2) Heat
      pain detection threshold (HPDT), and pain during 1 min. thermal stimulation (p-TS.

      The order of the stimulations (HPDT and BTS) is randomised for each patient and each study
      day, by a random allocation sequence, computer-generated by Copenhagen Trial Unit and stored
      in sealed and opaque envelopes to secure adequate allocation concealment. p-TS is conducted
      subsequent to BTS and HPDT.

      The participants will complete the psychological tests Pain Catastrophizing Scale (PCS) and
      Hospital Anxiety and Depression Scale (HADS) in their private home prior to study day 1. The
      completed tests will be placed in opaque sealed envelopes to secure blinding of the
      investigator and outcome assessor.
    

Intervention name(s): Brief thermal sensitization; Pain during 1 min. thermal stimulation; Heat pain detection threshold
Intervention type(s): Other; Other; Other
Intervention description(s): A small area of the skin of the study participants are heated to 45 degree celsius for 3 minutes, followed by evaluation of secondary hyperalgesia.; A small area of the skin of the study participants are heated to 45 degrees celsius for 1 minute. During the 1 minute period, the study participant will continually report pain on an electronic visual analog scale.; The threshold for heat pain are evaluated by heating a small area of the study participants skin. When the study participant feels pain, the temperature (degrees celsius) is registered. 4 threshold measurements per session. Heat pain threshold is defined as the average temperature of the 4 measurements.
Other intervention name(s): Clinical pain model; Clinical pain model; Clinical pain model
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Experimental pain; Men
Study of Nighttime Dosing of Sublingual Tizanidine (12 mg) in Multiple Sclerosis (MS) Patients With Significant Spasticity
Condition: Muscle Spasticity
MeSH terms: Muscle Spasticity; Multiple Sclerosis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Nightly administration of 8 mg of a unique sublingual (under the tongue) formulation of
      tizanidine, a known anti-spasticity medication, has been shown in a previous study to improve
      next-day spasticity, about 12 hours following dosing in 20 multiple sclerosis (MS) patients.
      This improvement was statistically significant when compared to oral tizanidine dosing. The
      current study is being undertaken to see if increasing the dose to 12 mg once nightly will
      result in an even greater improvement, with a longer effect, i.e., next day improvement in
      spasticity both in the morning as well as in the late afternoon.
    

Detailed description: 
      Sublingual tizanidine, a novel test formulation of the known effective antispasticity agent,
      has been shown to have a unique pharmacokinetic profile [(i.e., nearly twice the
      bioavailability/AUC), but with little or no increase in peak plasma levels (Cmax) as compared
      to oral tizanidine (Zanaflex)]. When administered nightly to 20 MS patients, at a dose of 8
      mg, it was shown to improve next-day spasticity (statistically significant improvement in
      Ashworth scores) about 12 hours post-dosing), improvement in nighttime (first quartile) sleep
      efficiency (as demonstrated by actigraphic measurement), and no increase in daytime
      somnolence.

      Current study is being undertaken to evaluate if increased dosing (12 mg once nightly) of
      sublingual tizanidine (vs. oral) will show a concomitant increase in clinical effect, i.e.,
      longer improvement, with next-day spasticity score improvement both in AM (as previously) as
      well as at PM (late afternoon) evaluation, with no increase in daytime somnolence.
    

Intervention name(s): Tizanidine (sublingual or oral)
Intervention type(s): Drug
Intervention MeSH terms: Tizanidine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Multiple Sclerosis; Spasticity; Sublingual Tizanidine; Ashworth Scores; Spasticity in Multiple Sclerosis Patients
A Study of LY2624803 in Japanese Participants With Transient Insomnia
Condition: Sleep Initiation and Maintenance Disorders
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of this study is to learn how different doses of LY2624803 affect sleep in healthy
      Japanese participants. The study has four treatment periods. Participants will receive a
      single dose of LY2624803 or placebo in each treatment period.
    


Intervention name(s): LY2624803 - Solution; LY2624803 - Capsule; Placebo - Solution; Placebo - Capsule
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Administered orally as reconstituted solution; Administered orally as a capsule; Administered orally as solution; Administered orally as a capsule
Intervention MeSH terms: Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
The Effect of a Nutritional Supplement Product Containing Cactus Fruit Juice (Nopalea) on C-Reactive Protein
Condition: Inflammation
MeSH terms: Inflammation
Study type: Interventional

Summary: 
      This study has been developed to investigate the anti-inflammatory effects of a commercial
      product (Nopalea) containing Prickly Pear Cactus Fruit Juice in healthy adults. The research
      method employs a double blind, placebo controlled, and time-series (repeat measures) design
      with high-sensitivity C-Reactive Protein (HS-CRP) serving as a marker for inflammation -
      testing for levels of CRP at time points: baseline (pre-test), 8 weeks (60 days) and 12 weeks
      (90 days). The final time point (i.e., 12 weeks) will serve as the post-test. It is expected
      that baseline CRP levels in healthy participants will decline.
    


Intervention name(s): NOPALEA
Intervention type(s): Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention
Keywords: CRP; Nopalea; Fruit; Juice
Ultrasound Assessment of Clear Liquid Intake During Labour
Condition: Anesthesia
Study type: Interventional

Summary: 
      We designed a two arms prospective, randomised, simple blinded trial to compare the impact of
      clear liquid intake on gastric content before delivery. We hypothesize that there will be no
      difference between the two groups, leading to safety of clear liquid intake during labour.
    

Detailed description: 
      Gastric emptying is a major concern for anesthetists in obstetric. In order to prevent the
      risk of gastric aspiration, we are used to forbid to eat and to drink during labour.

      However, this behaviour is controversial and some studies have shown that clear liquid intake
      can be safe during labour. Informations from a bedside ultrasound examination of the stomach
      content may be a useful tool to balance benefits and risks of such attitude. This technique
      has recently been shown very promising in pregnant women for the assessment of the gastric
      volume.
    

Intervention name(s): Apple juice
Intervention type(s): Other
Intervention description(s): Intervention consists in allowing drinks during labour
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Add-on Complex Ayurvedic Treatment in Fibromyalgia-Syndrome Compared to Standard Care Alone
Condition: Fibromyalgia Syndrome
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes; Syndrome
Study type: Observational

Summary: 
      The aim of this study is to evaluate the effectiveness of an additive complex āyurvedic
      diagnosis and treatment compared to conventional standard care alone in stationary patients
      with Fibromyalgia Syndrome.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Men and Women with Fibromyalgia-Syndrome between 18 und 70 years of age
      
Keywords: Fibromyalgia Syndrome; Fibromyalgia; Ayurveda; Traditional Indian Medicine; CAM; Pain; Chronic Widespread Pain
Modulation of Autophagy in Patients With Advanced/Recurrent Non-small Cell Lung Cancer - Phase II
Condition: Non-small Cell Lung Cancer; Advanced Non-small Cell Lung Cancer; Recurrent Non-small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Recurrence
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to examine the combination of one standard treatment for lung
      cancer plus an additional drug, hydroxychloroquine. The standard treatment for lung cancer
      being used includes 2 chemotherapy drugs, called paclitaxel and carboplatin. Some patients
      who have a specific type of lung cancer can also receive another drug, a drug that targets
      blood vessels, called bevacizumab (also known as avastin). Hydroxychloroquine is an FDA
      approved drug for the treatment of malaria, rheumatoid arthritis and lupus erythematosis.
    


Intervention name(s): Paclitaxel; Carboplatin; Hydroxychloroquine; Bevacizumab
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Paclitaxel will be given at a dose of 200 mg/m2(by IV over 3 hours on Day 1). Cycles every 3 weeks for 4-6 Cycles.
Prior to receiving paclitaxel, all patients will receive the following premedication:
Dexamethasone 20 mg po 12 and 6 hours prior to paclitaxel infusion (patients may be treated with dexamethasone 20 mg iv < 1 hour prior to infusion with paclitaxel if the patient did not take the oral dexamethasone)
Diphenydramine 50 mg iv (or equivalent) < 1 hour prior to paclitaxel infusion
Ranitidine 50 mg iv < 1 hour prior to paclitaxel infusion (alternatively other H2-blockers may be used); Carboplatin will be given at AUC = 6 by IV over 15-30 minutes on Day 1 immediately following paclitaxel. Cycles every 3 weeks for 4-6 Cycles.; Hydroxychloroquine will be given as a flat dose of 200 mg orally BID (total daily dose of 400 mg). Cycles every 3 weeks for 4-6 Cycles.; Cohort 1 only:
Bevacizumab will be given by IV on Day 1 of each 21-day cycle at a dose of 15 mg/kg. Cycles every 3 weeks for 4-6 Cycles.
Other intervention name(s): Taxol; Paraplatin; Plaquenil; Avastin
Intervention MeSH terms: Hydroxychloroquine; Paclitaxel; Bevacizumab; Carboplatin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Lung cancer; Non-small cell lung cancer; Advanced non-small cell lung cancer; Recurrent non-small cell lung cancer
Application of Electrical Neurostimulation Transcutaneous in Patients With Primary Dysmenorrhea.
Condition: Primary Dysmenorrhea
MeSH terms: Dysmenorrhea
Study type: Interventional

Summary: 
      The present study aims to verify the analgesic potential of a new methodological proposal for
      application for transcutaneous electrical nerve stimulation (TENS interactive) using patients
      with primary dysmenorrhoea and compare it with placebo in a randomized double blind study
      with convenience sample.
    

Detailed description: 
      The denouement will be the intensity of pain from visual analogue scale.
    

Intervention name(s): TENS; TENS (sham)
Intervention type(s): Device; Device
Intervention description(s): In the active group there was only one application with interactive TENS (n = 42) with the final parameters of frequency between 90 and 150pps and pulse duration between 300 and 400μs and intensity level of tolerance, lasting 35 minutes.; In the placebo group, there was a simulated single application, following the same procedures as the active TENS group, also for 35 minutes.
Other intervention name(s): TENS - eletric pulse generator
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: TENS; Dysmenorrhea; analgesia; interactive
Effects of Nurse-counselling in the Improvement of the type1 Diabetes Control in Adolescents
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The incidence of type 1 diabetes is increasing in France. A recent cross sectional study has
      shown that in France, only 15% of children and 26% of adults had HbA1c<7%. Adolescents seem
      to need particularly a better metabolic control.

      Working Hypothesis:

      We hypothesized that a stricter control of glycaemia by nurse-counselling could probably
      improve metabolic control in adolescents with type 1 diabetes.

      Objectives:

      To show that nurse-counselling may improve levels of patient satisfaction.

      Methodology:

      The main criterion is the patient acceptance of diabetes measured by an analogical visual
      scale rated from 0 (I cope very well with my diabetes, I cope very badly with my diabetes) to
      10 cm. The scale will be measured every quarter within 12 months follow-up. We wish to
      improve patient's appreciation by 10 mm, near to "I cope very well with my diabetes".

      This is a randomised parallel group study with 36 subjects in each group. During the
      follow-up, the "routine follow-up" group will continue its routine care. The "complementary
      follow-up" group will be called by nurses every 15 days and consult monthly. HbA1c is the
      secondary criterion and will be measured every 3 months.

      The total study duration is 18 months including 6 months for the recruitment and 12 months
      for the patients follow-up
    


Intervention name(s): nurse-counselling
Intervention type(s): Behavioral
Intervention description(s): Phone calls performed by nurse 15 days after each monthly visit
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Type1 diabetes;; nurse-counselling;; adolescent