bioihbjkbjnl/mcl2 huggingface dataset:
Analgesic Efficacy of Smoked Cannabis
Condition: Pain; Hyperalgesia
MeSH terms: Hyperalgesia
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to determine whether or not inhaled marijuana displays any
      pain-relieving properties on experimentally-induced pain.
    

Detailed description: 
      It is important to evaluate the effects of the cannabinoids on facilitated pain as conditions
      of hyperalgesia more closely approximates the clinical situation. There are limited clinical
      studies on the effect of the cannabinoids on facilitated pain states. Noyes et al evaluated
      the analgesic effects of Delta-9-THC in 34 cancer patients with pain. They concluded that
      20mg of oral Delta-9-THC was similar to 120mg of codeine (Noyes et al, 1975). Jain et al
      concluded that 1.5-3mg of intramuscular Levonantradol resulted in significant pain relief as
      compared to placebo in 56 patients with acute postoperative pain (Jain et al, 1981).

      Comparison(s): Three different doses of smoked cannabis will be compared to placebo for the
      reduction of experimentally induced pain.
    

Intervention name(s): Smoked Cannabis
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Pain; Cannabis; Analgesic
Evaluate the Efficacy and Safety of N02RS1 in Patient With Acute Bronchitis
Condition: Acute Bronchitis
MeSH terms: Bronchitis; Acute Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      A multi center, randomized, double-blind, placebo-controlled, parallel, phase 2b clinical
      trial to evaluate the efficacy and safety of N02RS1 in patients with acute bronchitis
    

Detailed description: 
      Suitable subjects randomized to the experimental or control group. The subjects eat IP during
      7days. Visit 3(3 days) evaluate BSS through phone call and visit 4(8 days) evaluate efficacy
      and safety.
    

Intervention name(s): N02RS1 1200mg; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 1200mg/day, Three times a day orally, 2 tablets once, 7 days; 1200mg/day, Three times a day orally, 2 tablets once, 7 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Evaluation of the Translation of the DE-PLAN Program for the Primary Prevention of Type 2 Diabetes in Routine Primary Care
Condition: Prediabetic State
MeSH terms: Prediabetic State
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the feasibility and effectiveness of the DE-PLAN
      Euskadi program for the primary prevention of type-II diabetes in high-risk population seen
      in primary care centers (Osakidetza-Basque Health Service) in which such intervention is
      implemented, compared to usual care control centers.
    

Detailed description: 
      Objective: To evaluate the feasibility and effectiveness of the DE-PLANЄ program for the
      primary prevention of type-II diabetes in high-risk population seen in primary care centers
      (Osakidetza) in which such intervention is implemented, compared to usual care control
      centers.

      DESIGN AND METHODS: A phase IV cluster randomized prospective clinical trial, conducted in 14
      primary care centers from Osakidetza, which will be randomly assigned to intervention or
      control group, that will collect a sample of 2534 followed for two years, aged 45 to 70 years
      without diabetes but with high risk of developing it (FINDRISC scale> 14), identified by a
      screening system. Nurses in intervention centers (GI) will implement DEPLANЄ for 12 months, a
      structured educational intervention on healthy lifestyles (diet and physical activity), while
      patients of the control centers will receive standard care for the prevention and treatment
      of type-II diabetes.

      ANALYSIS: The feasibility will be reported as the reach, adoption and implementation of the
      program. The attributable effectiveness of the program will be determined by comparing the
      changes in the incidence and risk of developing diabetes in healthy habits quality of life,
      observed in patients exposed to DE-PLANЄ intervention and of patients from control centers.
      The incremental cost-utility of DE-PLANЄ program will be also analysed.
    

Intervention name(s): DE-PLAN; Control group
Intervention type(s): Behavioral; Behavioral
Intervention description(s): structured group or individual educational sessions (4 to 5) on diet and physical activity, plus ongoing reminder contacts (e-mails, sms, etc) during 1 year; Standard advice for lifestyle change
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Lifestyle; Prediabetic State; Patient Education; Primary Health Care
The United States Healthy Living Study
Condition: Colo-rectal Cancer
MeSH terms: Rectal Neoplasms
Study type: Interventional

Summary: 
      The purpose of this study is to pilot test the efficacy of a patient-centered, tailored
      message intervention delivered via virtual human technology for increasing colorectal cancer
      (CRC) screening within guidelines. Although participation is not limited to these groups, the
      study team is particularly interested in the feasibility of the intervention for reaching
      racial/ethnic minority and rural patients.
    

Detailed description: 
      The primary goal of the study is to reduce colorectal cancer (CRC) morbidity and mortality by
      increasing CRC screening rates among the at-risk patient community and to reduce racial and
      geographic (rural vs. urban) disparities in CRC screening and mortality rates. To accomplish
      this long-term goal, this study aims to develop and test precision messaging tailored to
      target audiences through development and evaluation of culturally sensitive, interactive
      messages about CRC screening delivered using VHT. The study will investigate whether
      interactive, tailored messages contribute to an overall enhancement of knowledge of CRC and
      screening options by eliciting positive attitudes and behaviors toward FIT screening.

      To date, there is no other study that has looked to partner specific message strategies and
      colorectal cancer screening with an emphasis on racial concordance and modality. As such, the
      researchers hope to shed new light on how, as health communicators, to more successfully
      engage target audiences to change attitudes and/or behaviors towards getting screened for
      colorectal cancer.
    

Intervention name(s): message delivered via virtual technology
Intervention type(s): Behavioral
Intervention description(s): The intervention is precision messaging tailored to target audiences through development and evaluation of culturally sensitive, interactive messages about CRC screening delivered using VHT. The study will investigate whether interactive, tailored messages contribute to an overall enhancement of knowledge of CRC and screening options by eliciting positive attitudes and behaviors toward FIT screening.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Participant)
Primary purpose: Screening
Metabolic Response to Chardonnay Grape Marc Powder
Condition: Dyslipidemia; Obesity
MeSH terms: Dyslipidemias
Study type: Interventional

Summary: 
      To determine if the addition of chardonnay grape marc (also called pomace) powder enriched
      with grape seed extract to the diet will result in reducing blood levels of cholesterol or
      triglycerides.
    

Detailed description: 
      Previous research on grape seed nutritional properties has predominantly been confined to
      grape seed extracts (GSE) containing only soluble components. In animal models, GSE has been
      shown to prevent increases in blood pressure, blood cholesterol, and insulin resistance. In
      humans, there have been improvements in blood pressure, however no significant effect on
      blood cholesterol levels. Whole milled grape marc flours deliver more dietary complexity than
      seed extracts alone. In addition to the extractable and non-extractable polyphenols, flour
      offers dietary fiber, minerals, sterols and polyunsaturated fats. Grape marc flour is
      currently used as a food ingredient that is incorporated into various baked goods. However,
      to obtain good control of the dose level, the product will be provided in capsule form for
      this study. For reference, a ½ cup of of a high polyphenol food such as blueberries, contains
      about 325 milligrams of polyphenols, thus even with the higher dose, participants will be
      receiving an amount of polyphenols that is less than ¼ cup of blueberries. The grape marc
      powder is prepared in a facility that is certified for producing food-grade products, and the
      nutritional composition and safety of the product will be thoroughly evaluated before we
      begin the study. The objective of the current study is to determine if this chardonnay grape
      marc powder enriched with grape seed extract supplementation has beneficial impacts on the
      human blood lipid profile and to correlate gut biome changes to human metabolism.
    

Intervention name(s): Chardonnay grape marc marc high polyphenol dose (120mg); Chardonnay grape marc powder low polyphenol dose (75mg); Placebo (0mg)
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 3 prepackaged capsules taken once in the morning with meal for 3 weeks. The total dose will be 120mg of total polyphenols; 3 prepackaged capsules taken once in the morning with meal for 3 weeks. The total dose will be 75mg of total polyphenols; 3 prepackaged capsules taken once in the morning with meal for 3 weeks. The total dose will be 0mg of polyphenols
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: cholesterol; triglyceride; grape seed extract; chardonnay marc powder; polyphenol; gut microbiome
A Study To Investigate The Safety And Metabolism Of GSK376501 In Overweight Subjects
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2; Overweight
Study type: Interventional
Phase: Phase 1

Summary: 
      This study represents the first administration of GSK376501 in humans and the goal is to
      evaluate its initial safety and tolerability. The way the human body processes GSK376501 will
      also be determined.
    

Detailed description: 
      A Single-Blind, Randomized, Placebo Controlled, Ascending Single and Repeat Dose Study with
      Once Daily Dosing to Evaluate the Safety, Tolerability, Pharmacokinetics, and
      Pharmacodynamics of GSK376501 and to Evaluate Food Effects and the Relative Bioavailability
      of a Tablet Formulation Compared to the Powder for Reconstitution Formulation in Healthy
      Overweight and Obese Subjects (DIX109177)
    

Intervention name(s): placebo; GSK376501
Intervention type(s): Drug; Drug
Other intervention name(s): placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Diagnostic
Keywords: GSK376501,; First Time in Human,; Single Dose,; Dose Escalation,; Healthy Overweight/Obese Volunteer
The Effect of Ischaemic-reperfusion on the Endogenous Fibrinolysis in Man
Condition: Ischaemic Heart Diseases
MeSH terms: Heart Diseases; Myocardial Ischemia; Coronary Artery Disease; Ischemia
Study type: Interventional

Summary: 
      Heart attacks are usually caused by a blood clot blocking an artery supplying blood to the
      heart. Current treatments are designed at relieving this blockage as quickly as possible to
      minimise damage to the heart muscle. However in restoring the supply of blood local damage
      known as "ischaemia-reperfusion injury" may occur. The aim of this study is to assess how
      clot forming and clot dissolving pathways are affected during this process, and examine the
      role of a natural inflammatory hormone, bradykinin. This will help us to understand the
      mechanism by which ischaemia-reperfusion injury may occur and to devise new treatments for
      heart attacks.
    


Intervention name(s): Forearm vascular study
Intervention type(s): Procedure
Intervention description(s): Forearm blood flow measured by venous occlusion plethysmography during interarterial infusion of substance P (2,4,8 pmol/min). Venous blood sampling via cannula in antecubital fossa.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Ischaemia reperfusion; t-PA; Fibrinolysis; Endothelial function
Efficacy and Safety of Zingiber Officinale Roscoe Extract on Body Fat
Condition: Obesity
Study type: Interventional

Summary: 
      This study was conducted to investigate the effects of daily supplementation of Zingiber
      officinale Roscoe extract on body fat.
    

Detailed description: 
      This study was a 12 weeks, randomized, double-blind, placebo-controlled human trial. Forty
      subjects were randomly divided into Zingiber officinale Roscoe extract 200 mg or placebo
      group. The investigators measured Body Fat Mass, Percent Body Fat, Fat Free Mass, weight, and
      body mass index.
    

Intervention name(s): Zingiber officinale Roscoe extract 200 mg; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 2 cap/day, 800 mg/cap for 12 weeks; Placebo for 12 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Diagnosing Adult Growth Hormone Deficiency
Condition: Growth Hormone Deficiency
MeSH terms: Dwarfism, Pituitary; Endocrine System Diseases
Study type: Interventional

Summary: 
      The purpose of this study was to validate the growth hormone releasing hormone (GHRH) plus
      arginine (GHRH+arg) stimulation test and it´s cut-off limits for diagnosis of adult growth
      hormone deficiency using the growth hormone (GH) Immulite 2000 Xpi assay calibrated against
      the IS 98/574 from the World Health Organization. A specific aim was to study the effect of
      gender and age on the peak GH response in the GHRH+arg test
    

Detailed description: 
      Adult growth hormone deficiency (AGHD) is a clinical entity including increased abdominal fat
      mass, decreased muscle mass, low bone density and adverse effects on quality of life and
      cardiovascular morbidity. These signs are nonspecific, and accurate diagnosis with laboratory
      tests in needed.

      The GHRH+arg test is used to diagnose AGHD, but the cut-off values vary based on controls
      used. At moment consensus cut-off criteria are BMI specific, but gender and age may also
      affect the GH response in the GHRH+arg.
    

Intervention name(s): GHRH plus arginine test
Intervention type(s): Other
Intervention description(s): One ug/kg GHRH [GHRH(1-29), GEREF Serono, Italy] was administered as an iv bolus at time 0 min, followed by arginine (L-arginine monohydrochloride, Braun, Melsungen, Germany) 0.5 g/kg (max 30g9 over 30 min. Blood samples were drawn at -15,0,15,30,45,60,75,90 min.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Phase II Pilot Controlled Study of Short Vs Longer Term Pimozide (Orap) Therapy in Tourette Syndrome
Condition: Tourette Syndrome
MeSH terms: Tourette Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      OBJECTIVES: I. Determine whether the time period between randomization and endpoint is longer
      in the short term pimozide therapy or longer term therapy in patients with Tourette syndrome.

      II. Determine whether tic severity, medication side effects, academic performance and
      psychosocial functioning are better in the short term pimozide therapy or longer term
      pimozide therapy.
    

Detailed description: 
      PROTOCOL OUTLINE: This is a combined open label and double blind randomized study.

      Patients receive pimozide (open label) orally until a stable level of tic control is achieved
      and remains unchanged for at least 1 month.

      Then, patients are randomized to one of two possible double blind treatments. In the short
      term pimozide group, patients receive pimozide over 2 weeks. Then, pimozide is gradually
      replaced by an inactive placebo within the following 10 weeks.

      Patients in the long term pimozide group receive pimozide. Patients continue treatment for 12
      months or until a worsening of tics or behavioral symptoms are present for which an increased
      dosage is required.

      Patients who do not experience an exacerbation of tics requiring an increase in dosage are
      followed for 1 year from the date of entry.
    

Intervention name(s): pimozide
Intervention type(s): Drug
Intervention MeSH terms: Pimozide
Allocation: Randomized
Primary purpose: Treatment
Keywords: Tourette syndrome; neurologic and psychiatric disorders; rare disease
Optimized Therapy in Severe Traumatic Brain Injured Patients
Condition: Traumatic Brain Injury; Coma
MeSH terms: Brain Injuries; Brain Injuries, Traumatic
Study type: Interventional
Phase: Phase 4

Summary: 
      Severe traumatic brain injury is associated with life-threatening and incapacitating
      secondary injury.

      Contemporary therapeutic interventions are aimed at preventing and treating secondary damage.
      In this context, improved cerebral metabolism is an important target in modern neurointensive
      care.

      The main hypothesis is that continuous intravenous infusion of glutamyl-alanyl dipeptide
      restores disturbed brain metabolism following severe traumatic brain injury.
    

Detailed description: 
      Patients suffering from severe traumatic brain injury and requiring multimodal
      neuromonitoring during pharmacological coma will receive alanyl-glutamine dipeptide
      (Dipeptiven) as part of standard clinical nutrition.

      In two groups of patients the influence of different duration of infusion (group 1: 24 hours;
      group 2: 5 days) will be investigated. For this, pharmacokinetic and pharmacodynamic
      parameters in plasma and brain are determined.

      Increased plasma glutamine and alanine in arterial and jugular venous plasma and in cerebral
      microdialysates are to reflect efficacy of Dipeptiven infusion.

      Plasma glutamate levels as well as changes in cerebral glutamate, lactate, lactate/pyruvate
      ratio, intracranial pressure, bispectral index electroencephalography will be measured to
      exclude potential adverse effects
    

Intervention name(s): Dipeptiven
Intervention type(s): Drug
Intervention description(s): two groups: group 1: continuous infusion for 24 hours group 2: continuous infusion for 5 days
Other intervention name(s): Dipeptamin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: traumatic brain injury; glutamine; microdialysis; metabolism
Effects of Lumbar Traction on the Straight Leg Raise Test and Pain
Condition: Prolapsed Intervertebral Disc
MeSH terms: Intervertebral Disc Displacement
Study type: Interventional

Summary: 
      Disc prolapse causes impairment of function by nerve root compression compelling the patient
      to seek medical advice for low backache. Traction is one of the physical modalities
      frequently used for the treatment of lumbar disc herniations. So the purpose of the study is
      to determine the effect of one-fifth, one-half, and one-third of body weight traction on the
      straight leg raise test and pain.
    

Detailed description: 
      A total of 45 patients suffering from lumbar PIVD and having neurological symptoms will be
      selected for the study. Lumbar PIVD will be confirmed from MRI. Participants will be divided
      into three groups with 15 participants in each group. group A. for one-fifth of body weight
      traction, group b for one-third of body weight traction, and group C for one-half of body
      weight traction. SLR and pain will be measured before traction and after traction. A
      goniometer will be used to measure SLR and VAS will be used to measure pain.
    

Intervention name(s): Mechanical Traction
Intervention type(s): Procedure
Intervention description(s): Mechanical Traction will be applied to the lumbar region using a traction unit.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Three-arm parallel groups
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Mechanical Traction; Prolapsed intervertebral disc; straight leg raise test; pain
A Study to Evaluate the Effects of Food and Esomeprazole on the Pharmacokinetics of Crizotinib in a Coated Microsphere Formulation.
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will estimate the effect of food and the proton pump inhibitor, esomeprazole on
      the pharmacokinetics of crizotinib in a coated microsphere formulation.
    

Detailed description: 
      This study is an open-label, randomized, 4-period, 5-treatment, 6-sequence study in adult
      healthy volunteers. Subjects will receive up to four separate single oral 300 mg doses of a
      coated microsphere (cMS) formulation of crizotinib. Period 1 through Period 3 will evaluate
      the effect of food, and, the effect of multiple doses of a gastrointestinal acid reducing
      agent, esomeprazole, in fasted state, on the pharmacokinetics (PK) of crizotinib cMS. Period
      4 will evaluate whether apple sauce or orange juice may reduce the effect of multiple doses
      of esomeprazole on the PK of crizotinib cMS, if there is an effect.
    

Intervention name(s): Crizotinib; Esomeprazole
Intervention type(s): Drug; Drug
Intervention description(s): Crizotinib in a coated microsphere formulation; Proton pump inhibitor, esomeprazole
Intervention MeSH terms: Crizotinib; Esomeprazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science