bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of the Interest of the Medical Device Called "Fluobeam" in the Localization, Visualization of the Parathyroid Glands for Patients With Mild Primary Hyperparathyroidism
Condition: Mild Primary Hyperparathyroidism
MeSH terms: Hyperparathyroidism; Hyperparathyroidism, Primary
Study type: Interventional

Summary: 
      The aim of our study is to evaluate the value of the camera called "Fluobeam" in the
      localization, visualization of the parathyroid glands for patients with mild primary
      hyperparathyroidism.
    

Detailed description: 
      Recently, it has been shown that parathyroid glands presented auto fluorescence, visible in
      the near infra-red light. Parathyroid glands emit at 822 nanometers when they are stimulated
      by a laser of 785 nanometers. Fluoptics Company (Fluoptics SAS, Grenoble, France) will
      provide a camera called "Fluobeam", facilitating the visualization of the parathyroid glands.
      The fluorescence intensity of the parathyroid glands is much more elevated than that of the
      surrounding tissues.

      Preliminary work showed the interest of this technique. Benmiloud and collabortors have shown
      that the utilization of the "Fluobeam" enable to decrease the post total thyroidectomy
      hypocalcemia rate by a better visualization and preservation of the parathyroid glands.

      The aim of this study is to evaluate the value of "Fluobeam" in the localization,
      visualization of the parathyroid glands for patients with mild primary hyperparathyroidism.
    

Intervention name(s): Use of the camera "Fluobeam"
Intervention type(s): Device
Intervention description(s): Use of the camera "Fluobeam" to localize, visualize the parathyroid glands during a parathyroidectomy.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Statins in Cerebral Blood Flow and Neuronal Activity--A Pilot Study
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Observational

Summary: 
      Specific Aim: Demonstrate that statins have an effect on cerebral blood flow and neuronal
      activity
    

Detailed description: 
      A number of recent of recent studies suggests that statins, typically used to lower blood
      cholesterol have an effect on the brain. Patients treated with statins may have increased
      blood flow in the brain resulting in increased activity of the brain's neurons. The neuronal
      system is linked to memory. Brain magnetic resonance imaging (MRI) with magnetic resonance
      spectroscopy (MRS) and magnetic resonance perfusion (MRP) will be used to assess changes in
      neuronal activity in patients receiving statins vs. patients not receiving statins.

      This is a single-site non-randomized pilot study. The study will include twenty (20), healthy
      consenting patients between the ages of 45 and 65 who are candidates for statin therapy as
      determined by their cardiologist(s). Two imaging visits will be required, one magnetic
      resonance imaging with Magnetic Resonance Spectroscopy and Magnetic Resonance Perfusion at
      baseline and one magnetic resonance imaging with magnetic resonance Spectroscopy and Magnetic
      Resonance Perfusion three months later as described.

      Patients will have selected their course of clinical treatment prior to recruitment. Ten
      patients will have elected to start statin therapy with Lipitor and ten patients will have
      elected to initially lower their cholesterol levels with diet, independent of their
      participation in the study.

      Participants on the "statin arm" will receive a dose of 20 mg per day of Lipitor and will
      receive a baseline brain Magnetic Resonance Imaging with Magnetic Resonance Spectroscopy and
      Magnetic Resonance Perfusion prior to receiving Lipitor and follow-up brain Magnetic
      Resonance Imaging with Magnetic Resonance Spectroscopy and Magnetic Resonance Perfusion three
      months after beginning Lipitor.

      Participants on the "diet arm" will receive a baseline brain magnetic resonance imaging with
      Magnetic Resonance Spectroscopy and Magnetic Resonance Perfusion at the beginning of the
      study and follow-up brain magnetic resonance imaging with magnetic resonance spectroscopy and
      magnetic resonance perfusion three months later.
    

Intervention name(s): MRI, MR Spectroscopy, MR Perfusion
Intervention type(s): Device
Intervention description(s): One brain MRI/MR Spectroscopy/MR Perfusion at baseline and one brain MR/MR Spectroscopy/MR Perfusion at 3 months.
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        20 patients male and female
      
Keywords: Alzheimer's, magnetic resonance imaging
The Use of D5LR Versus LR for Induction of Labor and Time to Delivery in Multiparous and Primiparous Patient's With Favorable and Unfavorable Bishop's Scores
Condition: Induction of Labor Affected Fetus / Newborn
Study type: Interventional

Summary: 
      Currently, the optimum IV fluid for induction of labor is unknown. The goal of this study is
      to determine the optimum fluid for induction of labor, D5LR versus LR. The investigators
      hypothesize that patients assigned to the D5LR group will have a shorter induction of labor
      when compared to patient's in the LR group.
    

Detailed description: 
      Induction of labor is increasingly common in the United States, as the overall rate has
      increased from 9.5% in 1990 to 22.1% in 2006 with the goal to stimulate contractions prior to
      the onset of spontaneous labor. Cesarean delivery rates are also at an all-time high in the
      U.S., with more than 32% of patients being delivered by Cesarean in 2009. One of the most
      common indications for Cesarean section is a prolonged labor course. Patient's with a
      prolonged labor course are also at risk for infections, including chorioamnionitis and
      endometritis, as well as an increased risk of postpartum hemorrhage. There is a lack of
      information on ways to help shorten labor to potentially minimize these risks.

      The uterus is comprised of skeletal muscle, and labor has been likened to prolonged rigorous
      exercise. While oral hydration has been endorsed by ACOG for low-risk women in spontaneous
      labor, solid foods should be avoided. In turn, women with a prolonged induction or labor may
      benefit from glucose supplementation via IV fluids.

      The DEXTRONS study, J. Pare et al., looked at supplementation of D5LR versus normal saline in
      nulliparous patients who presented for a favorable induction of labor. This study showed a
      significant reduction in active labor time in the D5LR group versus the normal saline group.

      Currently, at Genesys Regional Medical Center, lactated ringers is the preferred IV fluid for
      patients presenting for induction of labor. This study will randomly assign patients to D5LR
      versus lactated ringers and examine the length of time from induction to delivery to
      determine if glucose supplementation has an effect on reducing length of induction in both
      nulliparous and multiparous patients for either a favorable induction of labor or an
      induction for post-dates. Secondary outcomes will include Apgar scores, need for special care
      nursery/NICU admissions, and mode of delivery. The study will begin in January 2019 and
      continue through July 2019. Patients who presented to labor and delivery and consent to be
      included in the study will be randomized to each group.
    

Intervention name(s): Lactated ringers; 5% dextrose lactated ringers
Intervention type(s): Other; Other
Intervention description(s): IV fluid; IV fluid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Once-Daily Oral Dose of BeneFlax to Healthy Older Adults
Condition: Oxidative Stress; Inflammation; Aging; Pain
MeSH terms: Inflammation
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The investigators are investigating whether the flax lignan, secoisolariciresinol
      diglucoside, decreases oxidative stress and inflammation. The flax seed lignan is believed to
      be broken down in the body to produce the health benefits of flax. Flax lignan is separated
      from the whole flax seed as this compound is believed to have health effects. Decreasing
      oxidative stress and inflammation should improve a number of the problems associated with
      aging. This intervention consists of 600 milligrams of the flax lignan SDG daily or an
      equivalent amount of whey protein.

      The investigators are comparing lignan to a placebo (whey powder) to examine whether a
      dietary intervention (i.e. flax seed containing lignan) might decrease oxidative stress and
      inflammation.
    


Intervention name(s): secoisolariciresinol diglucoside, vitamin D
Intervention type(s): Dietary Supplement
Intervention description(s): SDG supplementation as a packet of 1.6g/day of BeneFlax containing 600 mg SDG for 24 weeks Vitamin D Natural Product Number (NPN) 80003663 WN Pharmaceuticals Natural Factors Whey Factors
Other intervention name(s): BeneFlax Flax Lignan Extract Archer Daniels Midland,#080001.
Intervention MeSH terms: Vitamin D; Secoisolariciresinol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: lignans; oxidative stress; inflammation; aging; muscle weakness; pain
Study of Irinotecan and Bevacizumab With Temozolomide in Refractory/Relapsed Central Nervous System (CNS) Tumors
Condition: Central Nervous System Tumors
MeSH terms: Nervous System Neoplasms; Central Nervous System Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      Bevacizumab, irinotecan, and temozolomide are three agents shown to have promising activity
      in a variety of central nervous system tumors. No prospective studies have been published or
      are currently in progress within the major consortiums with this combination of drugs. Brain
      tumors are the second most common cause of cancer in pediatrics and the leading cause of
      cancer death in children. For children with High Grade Gliomas or with relapsed/refractory
      brain tumors, new agents in new combinations are needed. Historical data shows that newly
      diagnosed high grade gliomas 5 year progression free survival is 28-42%. Recurrent malignant
      gliomas median survival is 3-9 months. Recurrent medulloblastoma's 2 years survival is 9%.
      This study is a phase I study designed to provide an objective observation of toxicity and
      establish a maximum tolerated dose of this combination. In addition, this study will observe
      the response of children with relapsed or refractory central nervous system tumors.
    

Detailed description: 
      Bevacizumab dosing is 10 mg/kg on day 1 and day 15 of a 28 days course given IV.

      Irinotecan dosing is 125 mg/m2 on day 1 and day 15 of a 28 day course given IV for the first
      3 dose levels. If the MTD of temozolomide is not reached at dose level 3, then dose level 4
      will be an escalation of irinotecan to 150 mg/m2.

      For dose level 0 Temozolomide, dosing is 75 mg/m2/day day 1-5 of a 28 day course given PO.
      Doses will be escalated according to standard phase I dose escalation criteria.
    

Intervention name(s): Bevacizumab; Irinotecan; Temozolomide
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Bevacizumab 10 mg/kg IV on day 1 and day 15 of a 28 day cycle; Irinotecan 125 mg/m2 on day 1 and day 15 of a 28 day course given IV for the first 3 dose levels. If the Maximum Tolerated Dose of temozolomide is not reached at dose level 3, then dose level 4 will be an escalation of irinotecan to 150mg/m2.; For the first cohort (dose level 0) of patients, dosing is 75 mg/m2/day day 1-5 of a 28 day course given PO for the first course. Doses will be escalated according to standard phase I dose escalation criteria. Dose levels are as follows (Dose level 1 = 125mg/m2, Dose level 2 = 175mg/m2, Dose levels 3 and 4 = 200 mg/m2)
Other intervention name(s): Irinotecan and temozolomide; Bevacizumab and temozolomide; Bevacizumab and irinotecan
Intervention MeSH terms: Bevacizumab; Irinotecan; Temozolomide
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Clinical Effectiveness of Obturator Externus Muscle Injection in Chronic Pelvic Pain Patients
Condition: Chronic Pelvic Pain
MeSH terms: Pelvic Pain
Study type: Observational

Summary: 
      Obturator externus (OE) muscle has the possibility as a pain generator, considering its
      anatomical and functional aspects, but this muscle as a possible target for therapeutic
      intervention is currently understudied in pain practice.
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        The study population was defined as chronic pelvic pain patients with a localized
        tenderness on inferolateral side of the pubic tubercle corresponding to obturator foramen
        who received OE muscle injection with local anesthetic for their pain treatment.
      
Keywords: obturator externus
Atomoxetine vs Placebo in the Treatment of ADHD in Swedish Children and Adolescents
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 3

Summary: 
      Comparison of the effect of Atomoxetine and psychoeducation with placebo and psychoeducation
      after 10 weeks of treatment
    


Intervention name(s): Atomoxetine; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Atomoxetine Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Melatonin and Sleep in Preventing Delirium in the Hospital
Condition: Delirium
MeSH terms: Delirium
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Recent data suggests that melatonin, a supplement available over the counter, may help
      prevent delirium in hospitalized patients. The investigators are hypothesizing that melatonin
      may help in delirium prevention by improving sleep quality and possibly circadian rhythm
      cycling in patients who are given the supplement. This pilot study involves a randomized
      placebo-controlled design in which participants will be randomized to receive either
      melatonin 3mg orally or placebo orally. Participants in both groups will be fitted with
      wireless actigraphy devices to obtain objective sleep quality, and will also receive a sleep
      questionnaire each morning to obtain subjective data on their sleep quality overnight.
      Delirium will be assessed by floor nurses twice daily using the Confusion Assessment Method
      (CAM).
    


Intervention name(s): Melatonin; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Melatonin is the dietary supplement we are using in delirium prevention.; Patients in this group will receive a matching placebo pill.
Intervention MeSH terms: Melatonin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Delirium; Melatonin
Botulinum Toxin in Peripheral Neuropathic Pain
Condition: Postherpetic Neuralgia; Diabetic Polyneuropathies; Other Polyneuropathies
MeSH terms: Neuralgia; Polyneuropathies; Neuralgia, Postherpetic; Diabetic Neuropathies
Study type: Interventional
Phase: Phase 4

Summary: 
      Pain due to peripheral nerve lesion remains extremely difficult to treat and current
      treatments have onl moderate efficacy and/or side effects. The investigators have previously
      demonstrated the long term efficacy of Botulinum toxin type A (BTX-A) in a small group of
      patients with post-traumatic/postherpetic neuralgia and allodynia. The present study aims to
      a/ confirm the efficacy of repeated applications of BTX-A in a larger group of patients with
      peripheral neuropathic pain with or without allodynia(primary outcome) ; b/ evaluate its
      mechanisms of action ; c/analyse the predictors of response ;d/analyse whether the second
      injection is associated with a therapeutic gain. This will be a randomized placebo controlled
      study. A total of 30 patients will be randomized to receive either BTX-A (subcutaneous
      injection in the painful area) or placebo. Each injection will be repeated within at least 3
      months depending on the duration of efficacy. Skin punch biopsies will be performed before
      and 1 month after BTX-A administration. The investigators postulate that this study will
      confirm the clinical efficacy and good safety of repeated administrations of BTX-A in the
      treatment of peripheral neuropathic pain.
    


Intervention name(s): botulinum toxin type A
Intervention type(s): Drug
Intervention description(s): BTX A : 5 units/0.2 ml, maximum 300 units will be injected subcutaneous in the painful area ; this will be performed after randomization and within a minimum of 3 months interval depending on the duration of efficacy (maximum 6 months) Saline will be injected in the same volume in the painful area within the same frequency
Other intervention name(s): botox
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: BOTULINUM TOXIN; NEUROPATHIC PAIN; RANDOMIZED CONTROLLED TRIAL
Bicuspid Valve Aortopathy Feasibility Study
Condition: Bicuspid Aortic Valve
MeSH terms: Bicuspid Aortic Valve Disease
Study type: Observational [Patient Registry]

Summary: 
      In order to determine the effectiveness of medical therapy options to prevent enlargement of
      the aorta in patients with a bicuspid aortic valve, a randomized study will be planned. This
      feasibility study will gather accurate data on number needed to screen, changes in medication
      use over time, and variance of the intended study endpoint.
    

Detailed description: 
      The study will consider all patients with a bicuspid aortic valve and 1) determine the number
      of patients needed to be screened for a clinical trial, based on patient eligibility
      percentages applying specific inclusion and exclusion criteria, 2) for those meeting these
      criteria, follow changes in and compliance with medical therapy over two years, and 3) in a
      limited subset of eligible patients, perform MRI at baseline and after 2 years to measure the
      change in aortic area over time.
    

Intervention name(s): No interventions
Intervention type(s): Other
Other intervention name(s): Observation only
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with a bicuspid aortic valve.
Affect Management Intervention for Early Adolescents Wtih Mental Health Problems
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      Adolescents are at risk for HIV because of sexual and drug use behavior initiated during
      early adolescence, and those with mental health problems appear to be particularly
      susceptible. Problems with managing emotions may make it difficult for early adolescents to
      make good decisions about sexual and substance use behaviors. This project will develop and
      evaluate interventions for early adolescents with mental health issues. An intervention
      focused on teaching affect management skills will be compared to an intervention addressing a
      variety of health topics to determine which intervention best reduces risk behavior among
      this at-risk population.
    


Intervention name(s): Affect Management; General Health Promotion
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 12-session group intervention including affect management training as well as sexual health skills training; 12-session group intervention including health information on a variety of developmentally relevant health topics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: HIV prevention
Evaluate Clinical Research From Commerical Oral Care Products
Condition: Gingival Diseases
MeSH terms: Gingival Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to conduct a clinical study comparing anti-plaque efficacy of
      commercial oral care products.
    

Detailed description: 
      The purpose of this study is to compare efficacy of two commercially available toothpastes
      and one oral rinse on dental plaque control.
    

Intervention name(s): Fluoride; Triclosan/Fluoride; Chlorhexidine Gluconate
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Brush twice daily; Half mouth toothbrushing twice daily for 4 days; Mouth rinsing twice a day for 4 days
Other intervention name(s): monofluorophosphate; sodium fluoride; triclosan; Chlorhexidine Gluconate oral rinse
Intervention MeSH terms: Chlorhexidine; Chlorhexidine gluconate; Triclosan; Fluorides; Sodium Fluoride; Fluorophosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment