bioihbjkbjnl/mcl2 huggingface dataset:
To Study the Peripheral Effect of Botulinum Toxin-A (Botox-A) on Experimentally Induced Cutaneous Pain in Healthy Subjects
Condition: Healthy
Study type: Interventional

Summary: 
      This is a human trial to study the peripheral effect of therapeutic botulinum toxin
      (botox-A). The trial is performed on healthy normal males. The study comprises of two
      parallel placebo-controlled, double blinded studies.

      In experiment 1 intramuscular Botox will be given in corrugator (one site) and frontalis (two
      sites) muscles on one side and placebo to the other side. Intradermal (i.d.) capsaicin
      injection will be given to both sides (between the two sites of frontalis injection
      horizontally). Capsaicin-induced pain intensity and flare together with the area of
      hypersensitivity to different stimulus modalities will be measured and mapped at specific
      time points using different cutaneous stimuli (thermal, electrical, tactile, pressure). This
      will characterize which fibres and receptors are affected by Botox and will show if Botox
      have a unilateral effect (peripheral) or if it also affects the contralateral side (central
      effect).

      In experiment 2 intradermal Botox will be given in corrugator (one site) and frontalis (two
      sites) muscles on one side and placebo to the other side. I.d. capsaicin injection will be
      given to both sides (between the two sites of frontalis injection horizontally).
      Capsaicin-induced pain intensity and flare together with the area of hypersensitivity to
      different stimulus modalities will be measured and mapped at specific time points using
      different cutaneous stimuli (thermal, electrical, tactile, pressure). This will characterize
      which fibres and receptors are affected by Botox. The effect of intradermal Botox will be
      compared to the results of experiment 1.

      The two experiments will show if the intramuscular Botox exerts its action via a leak of
      Botox from the muscle to the overlying skin.

      Antipruritic effects of Botox on histamine prick test and itch will also be assessed in
      parallel with the experiment 2. In this sub-experiment, 5 Units of Botox will be injected
      intradermally in the middle of volar forearm. The same volume of placebo will be injected
      into the other side. Histamine prick test will induce itch and the effect of intradermal
      Botox will be assessed compared to the baseline. Flare area and visual analogue scale (VAS)
      ratings will be measured.
    


Intervention name(s): Botox (Allergan Inc., US)
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Health Services Research
Keywords: The trial is performed on healthy normal males.
Effects of Inorganic Nitrate and Intensity of Exercise on Cardiovascular Health in Post-Menopausal Females
Condition: Vascular Dilation; Arterial Stiffness
MeSH terms: Dilatation, Pathologic
Study type: Interventional
Phase: Phase 1

Summary: 
      Post-menopausal females experience elevated cardiovascular disease risk (CVD), compared to
      premenopausal females and age-matched males. Current exercise guidelines appear inadequate to
      ameliorate this increased risk and higher intensity exercise may be necessary. Oral inorganic
      nitrate supplementation enhances both exercise performance and CVD risk profile in several
      clinical conditions. However, the effects of this intervention in post-menopausal females is
      unexplored.
    

Detailed description: 
      The purpose of this study is to determine whether acute inorganic nitrate supplementation and
      exercising at different exercise intensities (high vs moderate) improve vascular health in
      post-menopausal females.
    

Intervention name(s): BEET IT - Concentrate Beet root juice; BEET IT - Concentrate Beet root juice (nitrate depleted)
Intervention type(s): Drug; Drug
Intervention description(s): Beet It Sport (James White Drinks, Ltd.) each containing 400mg of inorganic nitrate (~6.5 mmol) will be consumed twice daily (totalling ~13 mmol of inorganic nitrate per day) for at least 2 days prior to testing visits, as well as 2 hours prior to testing visits.; Beet It Sport (James White Drinks, Ltd.) each containing 0mg of inorganic nitrate (~0 mmol) will be consumed twice daily (totalling ~0 mmol of inorganic nitrate per day) for at least 2 days prior to testing visits, as well as 2 hours prior to testing visits. It is provided by the same company that produces the concentrated beet root juice shots (James White Drinks) but the placebo version is nitrate-depleted.
Other intervention name(s): Dietary Nitrate supplementation (nitrate rich); Dietary Nitrate supplementation (nitrate depleted)
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subject are stratified randomized to consume either beetroot juice with, or without, inorganic nitrate and will consume this same supplement throughout all testing
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Flow-mediated dilation; Pulse wave velocity; Exercise intensity; Vascular function
Assessment of Optimal Egg Intake in a Healthy Population
Condition: Cardiovascular Disease
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      Recently, the United States Department of Agriculture (USDA) has recommended removal of the
      300mg/day limit on dietary cholesterol intake due to a lack of evidence supporting a
      connection between cholesterol intake and increased risk for cardiovascular disease (CVD).
      Previous work has shown that daily intake of eggs actually favorably alters many parameters
      associated with CVD risk. Conversely, emerging research suggests that choline, a nutrient in
      eggs, may be converted into trimethylamine oxide (TMAO) by the intestinal microbiota. TMAO is
      thought to increase the risk for CVD. Therefore, the purpose of this study is to determine a
      threshold of daily egg intake at which the risk for CVD is not negatively impacted in a
      young, healthy population.
    

Detailed description: 
      The purpose of this study is to establish a threshold of egg intake at which CVD risk is not
      negatively altered in young, healthy individuals. Participants (age 18-30, healthy lipid
      profile) will undergo a 2-week washout period followed by daily intake of 1, 2, and 3 eggs
      per day for 4 weeks each. Blood samples will be collected at baseline and following each
      4-week dietary period. Samples will be analyzed to determine the impact of daily intake of
      increasing numbers of eggs on blood lipids, TMAO, biomarkers of oxidative stress and
      inflammation, and expression of cholesterol-related genes.
    

Intervention name(s): Eggs
Intervention type(s): Other
Intervention description(s): Participants will complete a 2-week washout period followed by intake of 1, 2, and 3 eggs per day for 4 weeks each.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
A Research Study to Characterize the Pharmacodynamics and Safety of Repeat Dose SP-102
Condition: Lumbosacral Radicular Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      This is an open-label, single-arm, repeat dose study to characterize the pharmacodynamics and
      safety/tolerability of SP-102 administered by epidural injection.
    


Intervention name(s): SP-102
Intervention type(s): Drug
Intervention description(s): Injection
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: lumbosacral radicular pain; sciatica; leg pain
Effect of Hyoscine and Promethazine on Labor Pain
Condition: Labor Pain
MeSH terms: Labor Pain
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      It is always considered to shorten the duration of delivery without compromising the mother
      and fetus by obstetrics. Hyoscine and Promethazine are used widely in hospital and research
      is very limited, with conflicting results regarding the efficacy of these two drugs. So the
      investigators decided to compare of effect of hyoscine N-butyl bromide and Promethazine on
      length of active phase of the first stage of labor.
    


Intervention name(s): Hyoscine; Promethazine
Intervention type(s): Drug; Drug
Intervention description(s): The samples were randomly allocated to inject of 20 mg of hyoscineIM in dilatation 3-5cm.; The samples were randomly allocated to inject of 25 mg of promethazine IM in dilatation 3-5cm.
Intervention MeSH terms: Promethazine; Diphenhydramine; Scopolamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Keywords: Hyoscine,; Promethazine,; The first stage of labor,; Labor pain
The Effect of Exercise on Disease Activity and Cardiovascular Risk for Patients With Axial SpondyloArthritis
Condition: Axial Spondyloarthritis
MeSH terms: Spondylitis; Spondylarthritis; Axial Spondyloarthritis
Study type: Interventional

Summary: 
      The overall aim of this multicenter randomised controlled trial (RCT) is to investigate if
      exercise can modify the disease course and prevent comorbidity in patient with
      spondyloarthritis (SpA).
    

Detailed description: 
      International guidelines recommend exercise as a cornerstone in the management of SpA. Due to
      the typical features of SpA with reduced spinal mobility, the main focus for exercise has
      been flexibility exercise. Exercise trials for this patient group have mainly aimed at
      improving spinal mobility and there is limited evidence of the potential effects of exercise
      on disease pathogenesis and CVD risk factors.
    

Intervention name(s): Exercise
Intervention type(s): Behavioral
Intervention description(s): An exercise program for 40-60 minutes three times a week in 3 months. Twice a week the exercise sessions will be supervised by a physiotherapist and these sessions will consist of endurance and strength training. The endurance training will be high intensity interval training on a treadmill. And strength training with external load for the major muscle groups (individually adapted: six exercises, eight to ten repetitions maximum, two to three sets). Once a week the participants will exercise individually for a minimum of 40 minutes of endurance exercise.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Perioperative Insulin, GIK or GLP-1 Treatment in Diabetes Mellitus
Condition: Diabetes Mellitus Type II
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The incidence of diabetes mellitus type II is increasing. More and more patients who need
      surgery have diabetes mellitus type II. Despite an enormous amount of glucose lowering
      protocols and the proven negative effects of hyperglycaemia. There is no evidence for the
      optimal glucose lowering protocol.

      This study investigates the optimal intraoperative treatment algorithm to lower glucose in
      patients with diabetes mellitus type 2 undergoing non-cardiac surgery, comparing
      intraoperative glucose-insulin-potassium infusion (GIK), insulin bolus regimen (BR) and GLP-1
      (liraglutide, LG) treatment.
    

Detailed description: 
      Diabetes mellitus is associated with poor outcome after surgery. The prevalence of diabetes
      in hospitalised patients is up to 40%, meaning that the anaesthesiologist will encounter a
      diabetes patient in the operating room on a daily basis. Multiple protocols for perioperative
      glucose regulation have been developed, ranging from intravenous glucose-insulin-potassium
      infusion to subcutaneous bolus regimens. Despite this abundance of published glucose lowering
      protocols and the proven negative effects of intraoperative hyperglycaemia in diabetes, there
      is no evidence regarding the optimal intraoperative glucose lowering treatment. Recently,
      incretins have been introduced to lower blood glucose. The main hormone of the incretin
      system is glucagon-like peptide-1 (GLP-1). GLP-1 increases insulin and decreases glucagon
      secretion in a glucose-dependent manner, resulting in low incidence of hypoglycaemia. This
      study investigates for the first time the optimal intraoperative treatment algorithm to lower
      glucose in patients with diabetes mellitus undergoing non-cardiac surgery.

      Objective:

      This study investigates the optimal intraoperative treatment algorithm to lower glucose in
      patients with diabetes mellitus type 2 undergoing non-cardiac surgery, comparing
      intraoperative glucose-insulin-potassium infusion (GIK), insulin bolus regimen (BR) and GLP-1
      (liraglutide, LG) treatment.
    

Intervention name(s): Liraglutide; Insulin bolus; GIK infusion
Intervention type(s): Drug; Drug; Drug
Intervention description(s): continuous infusion
Other intervention name(s): Victoza; novorapid; glucose, insulin, potassium infusion
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Liraglutide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: glucose; diabetes mellitus; perioperative
Anaysis of Phytotherapy Agent Against Periodontitis
Condition: Periodontitis
MeSH terms: Periodontitis
Study type: Interventional

Summary: 
      In light of the controversy that are already approved but that however still exists regarding
      the efficacy and influence of the decontaminant tools for the management of Periodontitis (,
      the aim of this study was to evaluate, at 6 months follow-up, the post-treatment clinical
      parameters and immunological and gingival microbial profiles in patients with periodontitis,
      treated by either SRP in addition to phytotherapeutic drug or SRP alone.
    

Detailed description: 
      This trial was conducted in accordance with the World Medical Association's Declaration of
      Helsinki of 1975, and reviewed in 2008. The local ethical committee of the University of
      Messina approved the study protocol and each patient was carefully informed about the
      possible inherent risks of the study and provided their informed written consent 34 patients,
      18 men and 16 women, aged 27 to 65 (mean age 44.2) were assessed for eligibility . In all
      subjects, subgingival plaque was acquired from 4 separate proximal sites at 365 days after
      therapy.

      The Gingival Crevicular Fluid (GCF) was gathered, at the same time from other four different
      non-contiguous interproximal sites using filter paper strips‡ as previously described. The
      levels of IL-1β, IL-10 and TNF-α were recognized by conventional enzyme-linked immunosorbent
      assay using an equation with software using a five polynomial parameter. Each selected
      subject underwent randomly, without anaesthesia, at the same time and after recording
      periodontal parameters, the two following treatments: in one, were treated as conventional
      Scaling and Root Planing (SRP) + phytotherapeutic drug (Neuridase), while the other group
      were treated as conventional SRP alone
    

Intervention name(s): gingival crevicular fluid evaluation
Intervention type(s): Diagnostic Test
Intervention description(s): anaysis of interleukins in gingival crevicular fluid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Comparison of Quality of Recovery (QoR)-15 Scores Between Propofol and Remimazolam Anesthesia
Condition: Patients Undergoing Thyroid Surgery for Neoplasm
MeSH terms: Thyroid Diseases
Study type: Interventional

Summary: 
      Remimazolam is a ultra-short-acting benzodiazepine that is rapidly metabolized in the body by
      tissue esterase and not accumulates in the body for long periods of infusion. In addition,
      similar to other benzodiazepines, it is possible to reverse the sedation and anesthetic
      effects through flumazenil. It has no injection pain and infusion syndrome compared with
      propofol. There is no study to investigate overall postoperative functional recovery via
      QoR-15 in patients receiving TIVA using remimazolam. The purpose of this study is to
      determine whether there is any difference in the quality of postoperative recovery between
      propofol-based and remimazolam-based total intravenous anesthesia in female patients
      undergoing thyroidectomy. The QoR-15 questionnaire score, pain, nausea/vomiting, and the
      frequency of complications are evaluated and compared between the two groups.
    


Intervention name(s): Arm I (Propofol group); Arm II (Remimazolam group)
Intervention type(s): Drug; Drug
Intervention description(s): Propfol group will be started and maintained total intravenous anesthesia with propofol and remifentanil .; Remimazolam group will be started and maintained total intravenous anesthesia with remimazolam and remifentanil.
Intervention MeSH terms: Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Hormones and Reduction in Co-users of Marijuana and Nicotine
Condition: Marijuana Dependence
MeSH terms: Marijuana Abuse
Study type: Interventional

Summary: 
      The purpose of this study is to examine the role of progesterone (a naturally occurring
      hormone found in both men and women) on reducing marijuana use. The investigators will see if
      progesterone effects impulsivity, withdrawal, mood and stress during marijuana cessation.
    

Detailed description: 
      This double-blind, randomized pilot clinical trial will prescreen an estimated 250 potential
      subjects, consent and further evaluate approximately 100 potential subjects, and ultimately
      enroll 70 subjects to ensure 40 subjects will provide a primary marijuana reduction outcome
      measure at four weeks post quit date. Subjects will be stratified by sex then randomized to
      one of two treatment groups (n=20 per drug group, 50% female): progesterone (PRO; 200mg
      2x/day) or Placebo (PBO). Telephone screening and visit invitation (20 minutes) leads to the
      consent process and in-person screening including medical-psychiatric evaluation for
      inclusion/exclusion (two visits, two hours each), then randomization and medication start (7
      days), then stable medication (28 days) with medication reduction and final evaluation (7
      days).
    

Intervention name(s): Progesterone; placebo
Intervention type(s): Drug; Drug
Intervention description(s): generic progesterone; placebo
Other intervention name(s): Promitrium, Crinone, Endometrin, Prochieve
Intervention MeSH terms: Progesterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Vaccine Therapy With gp100 and/or Sargramostim in Treating Patients With Malignant Melanoma
Condition: Melanoma (Skin)
MeSH terms: Melanoma
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Vaccines made from gp100 and sargramostim may make the body build an immune
      response to kill tumor cells.

      PURPOSE: Phase I trial to study the effectiveness of vaccine therapy with gp100 and/or
      sargramostim in treating patients who have malignant melanoma.
    

Detailed description: 
      OBJECTIVES: I. Determine the safety and toxicity of in vivo particle bombardment with DNA
      coated gold beads carrying cDNA for gp100, with or without gold beads carrying cDNA for
      sargramostim (GM-CSF), into uninvolved skin of patients with melanoma. II. Estimate the
      intensity and duration of gp100 transgene expression following these regimens in these
      patients. III. Assess local lymphocyte phenotype and systemic lymphocyte function following
      these regimens in these patients. IV. Compare gp100 transgene expression as well as local
      lymphocyte phenotype and systemic lymphocyte function when the cDNA for GM-CSF is
      administered 3 days before cDNA for gp100 vs on the same day as gp100 administration in these
      patients. V. Determine the effect of these regimens on tumor shrinkage, histological evidence
      of tumor inflammation or necrosis, or in vitro evidence of antitumor immune reactivity in
      these patients.

      OUTLINE: This is a dose escalation study. Patients are assigned to one of three treatment
      groups. Group I: Patients receive particle mediated gene transfer (PMGT) of gp100 on day 1 to
      2 or 4 separate sites. One site is biopsied on day 3. A second course is administered on day
      22 and one of the sites is biopsied on day 26. Delayed type hypersensitivity (DTH) is
      assessed on days 40 and 43. Group II: Patients receive PMGT of sargramostim (GM-CSF) on day 1
      to 1-5 separate sites. PMGT of gp100 is administered to 2-4 of these same sites on day 4. One
      of the gp100 sites is biopsied on day 6. A second course is administered beginning on day 22,
      with one of the sites biopsied on day 29. DTH is assessed on days 40 and 43. Group III:
      Patients receive PMGT of GM-CSF in combination with gp100 on day 1 to 2 or 4 separate sites.
      Courses are administered as in group I. Patients who achieve partial or complete response or
      maintain stable disease may receive another course of therapy. Cohorts of 3-6 patients are
      treated at each dose in each group until the maximum tolerated dose (MTD) is determined. The
      MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting
      toxicity. Patients are followed at 3, 6, and 12 months, and then annually thereafter.

      PROJECTED ACCRUAL: A total of 18 patients will be accrued for this study.
    

Intervention name(s): gp100 antigen; sargramostim
Intervention type(s): Biological; Biological
Intervention MeSH terms: Sargramostim
Primary purpose: Treatment
Keywords: stage IV melanoma; recurrent melanoma