bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Ketorolac and Remote Ischemic Preconditioning on Renal Ischemia-reperfusion Injury in Patients Undergoing Partial Nephrectomy
Condition: Renal Cell Carcinoma
MeSH terms: Carcinoma, Renal Cell
Study type: Interventional

Summary: 
      Partial nephrectomy is a widely accepted alternative to radical nephrectomy in patients with
      clinically localized, unilateral renal cell carcinoma and a normal contralateral kidney.
      Interruption of renal blood flow via pedicle clamping is often necessary during partial
      nephrectomy, especially for complex tumors with deep parenchymal invasion.
      Ischemia-reperfusion injury is a complex process involving several mechanisms including renal
      vasoconstriction, extensive tubular damage and glomerular injury. The investigators will
      examine the postoperative renal function of patients who received intraoperative ketorolac
      and remote ischemic preconditioning during partial nephrectomy.
    


Intervention name(s): Ketorolac tromethamine and remote ischemic preconditioning
Intervention type(s): Drug
Intervention description(s): Ketorolac tromethamine/ single / 1mg/kg/ intravenous administration 30 min before renal artery clamping, remote ischemic preconditioning / 200 mmHg / 5 min inflation and 10 min deflation / 3 cycles / after anesthetic induction
Intervention MeSH terms: Ketorolac; Ketorolac Tromethamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: ketorolac; remote ischemic preconditioning; partial nephrectomy
Theta Burst TMS as a Tool to Change Smoking Behavior
Condition: Smoking; Addiction
MeSH terms: Behavior, Addictive
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The goal of this study is to determine whether transcranial magnetic stimulation (TMS) is an
      effective treatment in decreasing craving in individuals who habitually smoke cigarettes. The
      study consists of six total visits to MUSC; one for the consent process, two that will
      include MRI scans, and five that will include TMS administration. Compensation will be
      provided for each visit.
    

Detailed description: 
      Prior and recent evidence suggests a role of medial prefrontal cortex (mPFC) in cigarette
      smoking. The present study will examine whether a five-day regimen of theta-burst
      transcranial magnetic stimulation (TMS) reduces cigarette smoking outside of the lab
      (examined through self-report and physiological measures) and motivation to smoke inside the
      lab (examined through behavioral tasks and functional MRI).
    

Intervention name(s): continuous theta burst stimulation (real); continuous theta burst stimulation (sham)
Intervention type(s): Device; Device
Intervention description(s): a form of transcranial magnetic stimulation that noninvasively induces a depression in brain reactivity; a sham version of a form of transcranial magnetic stimulation that noninvasively induces a depression in brain reactivity
Other intervention name(s): cTBS (active); cTBS (sham)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Transcranial Magnetic Stimulation
Sustained Acoustic Medicine for Chronic Low Back Pain Secondary to Herniated Nucleus Pulposus or Other Conditions
Condition: Chronic Low Back Pain (CLBP); Intervertebral Disc Displacement
MeSH terms: Intervertebral Disc Displacement; Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      ZetrOZ's Ultrasonic Diathermy device is intended for use as a portable and wearable medical
      device which, when applied to various areas of the body applies Low Intensity Therapeutic
      Ultrasound (LITUS) to deep tissues. This device is FDA-cleared for pain reduction, treatment
      of muscle spasm and joint contracture, and increasing local circulation. This study will look
      at the use of therapeutic ultrasound to relieve pain and reduce disability in subjects with
      chronic low back pain, a subset of which will have chronic low back pain due to a herniated
      disc, over an 8-week treatment period.
    


Intervention name(s): Sustained Acoustic Medicine (SAM); Sham Device
Intervention type(s): Device; Device
Intervention description(s): Long-duration, low-intensity therapeutic ultrasound device that is self-applied and wearable, delivering treatment up to 4 hours per day.; Inactive ultrasound device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: herniated disc; sustained acoustic medicine; ultrasound; CLBP
Plasma Exchange With Albumin in AMN Patients
Condition: Adrenomyeloneuropathy; Adrenoleukodystrophy
MeSH terms: Adrenoleukodystrophy
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Adrenoleukodystrophy (X-ALD) is the most common genetic disorder of the brain white matter
      with an incidence of 1:14,700 births. It is caused by mutations in the ABCD1 gene, which
      encodes a transporter of very long-chain fatty acids (VCLFA) into the peroxisome for
      degradation. As a consequence VLCFA accumulate in tissues and plasma being the pathognomonic
      biomarker for diagnosis. The excess of VLCFA produces mitochondrial ROS and oxidative damage,
      a major factor driving X-ALD pathogenesis. Other key dysregulated pathways are energy
      production, mitochondrial biogenesis and respiration, proteostasis, and ER stress. Current
      therapeutic options are unsatisfactory, restricted to bone marrow transplant and gene
      therapy, for which most patients do not qualify. The encouraging results of plasma exchange
      (PE) with albumin replacement for Alzheimer's Disease prompted us to start this study. Our
      rationale is the following: In plasma, VLCFA are transported by lipoproteins and albumin.
      Albumin is the major transporter of fatty acids (FA) to the brain. ABCD1 deficiency induces
      inflammation and increases blood-brain barrier leakage, which could facilitate increased
      permeability to albumin. We posit that replacement of albumin would lower VLCFA levels in
      plasma through peripheral sink mechanisms, diminishing the quantity of VLCFA reaching the
      brain, and would prevent lipid peroxidation. A pilot proof-of-concept study in 5 X-ALD
      patients will be carried out to replace endogenous albumin through PE applied, once a week
      the first month and monthly for 5 months. A 6 months follow-up after the end of the treatment
      will be carried out.
    


Intervention name(s): Albumin solution
Intervention type(s): Drug
Intervention description(s): plasma exchange with albumin, one per week for one month, then one per month for 5 months
Other intervention name(s): plasma exchange
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: plasma exchange; albumin; VLCFA
Effects of Ketogenic Diet in Divers Breathing Enriched Air Nitrox
Condition: Overweight and Obesity; Exertion; Excess; Oxygen Toxicity
MeSH terms: Overweight
Study type: Interventional

Summary: 
      Overweight divers face a challenging activity such as immersions, starting from a higher
      levels of circulating cytokines and oxidative stress. Ketogenic Diet (KD) is described as
      effective in weight loss, in countering inflammation and oxidative stress, and used in the
      control of drug-refractory seizures.

      The aim of our pilot study was to evaluate if a ketosis state induced by a specific dietary
      regime, may have a protective effect on oxidative stress damages and inflammatory status,
      that accompanies both overweight and diving activities.

      Blood and urine samples from six overweight divers were obtained a) before (CTRL) and after a
      dive breathing Enriched Air Nitrox and performing light underwater exercise (NTRX), b) after
      a dive (same conditions) performed after 7 days of KD (K-NTRX). We measured urinary
      8-isoprostane and 8-OH-2-deoxyguanosine evaluating lipids peroxidation and DNA oxidative
      damages. Plasmatic IL-1beta, IL-6 and TNF-alpha levels were measured to investigate the
      inflammatory status.
    


Intervention name(s): Ketogenic Diet
Intervention type(s): Dietary Supplement
Intervention description(s): Diet consisted of a very low carbohydrate ketogenic diet (for 7 days) with the use of some phytoextracts as previously described. The consumed diet was primarily made of beef and veal, poultry, fish, raw and cooked green vegetables without restrictions, cold cuts (dried beef, carpaccio and cured ham), eggs and seasoned cheese (e.g., parmesan). The allowed drinks were infused tea, moka coffee and herbal extracts. The foods and drinks that subjects had to avoid included alcohol, bread, pasta, rice, milk, yogurt, soluble tea, and barley coffee. To facilitate adherence to the nutritional regime, a variety of special meals based on protein and fibers were given to each subject. KD characteristics are protein intake 1.3g/kg/day, to maintain skeletal muscle mass; carbohydrates intake less than 40 g/day and 50-60% of total kcal to induce ketosis. In accordance with a hypocaloric profile, total energy intake was calculated with 200 kcal more than basal metabolic rate.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
A Pharmacokinetic Study to Characterize JNJ-39393406 in the Cerebrospinal Fluid of Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the concentration of JNJ-39393406 achieved in the
      blood and cerebrospinal fluid of healthy adult volunteers following administration of a
      single dose of JNJ-39393406.
    

Detailed description: 
      This is a single-centre, double-blind (neither physician nor patient knows the name of the
      assigned treatment), single dose study of JNJ-39393406 or placebo (a treatment identical in
      appearance to JNJ-39393406 but does not contain active drug) in healthy adult volunteers. The
      study consists of an eligibility screening examination (between 21 and 2 days prior to dose
      administration), a double-blind treatment period, and a follow-up examination (minimally 7
      and maximally 14 days after the dose administration). For each volunteer, the maximal study
      duration will not exceed 6 weeks. JNJ-39393406 or placebo will be administered as a single
      200-mg dose on Day 1 as a liquid nanosuspension (a formulation used to improve the solubility
      of the drug) with 240 mL (approximately 8 ounces or 1 cup) noncarbonated water between 8:00
      AM and 10:30 AM after a standard breakfast has been consumed (following a fast [not eating
      food] of at least 10 hours). Volunteers will then fast until approximately 4 hours after
      taking JNJ-3939406 or placebo after which lunch will be served.
    

Intervention name(s): JNJ-39393406; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Type= exact number, Unit= mg, Number= 200, Form= oral suspension, Route= oral administration. Oral suspension to be taken once with 240 mL (8 ounces of water) between 8:00 AM and 10:30 AM.; Form= oral suspension, Route= oral administration. Oral suspension to be taken once with 240 mL (8 ounces of water) between 8:00 AM and 10:30 AM.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Keywords: Healthy volunteers; JNJ-39393406-aaa; Pharmacokinetics; Central brain penetrance; Cerebral spinal fluid
Irritable Bowel Syndrome (IBS) Treatment With H1-receptor Antagonists
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      Purpose:

      To evaluate the efficiency of Irritable Bowel Syndrome (IBS) patients treatment with the
      H1-receptor antagonist ebastine.

      Design:

      Double blind randomized placebo controlled trial. IBS patients receive a 12-weeks treatment
      with ebastine 20mg once daily or placebo (1:1 randomization).

      End points:

      End point is the effect of treatment on clinical symptoms and visceral hypersensitivity which
      will be evaluated with a barostat test.
    


Intervention name(s): ebastine; placebo capsule
Intervention type(s): Drug; Drug
Intervention description(s): 20 milligram capsule once daily; one capsule once daily
Intervention MeSH terms: Ebastine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: visceral hypersensitivity; mast cells
The University of Michigan PCOS Intervention Using Nutritional Ketosis
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The goal of this proposal is to pilot test our existing very-low carbohydrate diet
      intervention, adapted for women with PCOS.
    

Detailed description: 
      Polycystic ovary syndrome (PCOS) is a common and costly ($4.3 billion/year) endocrine
      disorder that significantly impairs quality of life and increases the risk of obesity and
      type 2 diabetes as well as hyperandrogenism, infertility, hyperlipidemia, and cardiovascular
      disease. Diet and lifestyle weight-loss interventions are recommended as the first-line
      treatment of PCOS, but experts disagree about which nutritional approach is best. A review of
      previous diet and lifestyle trials in PCOS did find a slight benefit of lower carbohydrate
      diets for weight loss, glucose control, insulin, and insulin resistance. This may be because
      carbohydrate intake leads to increased insulin secretion, which then stimulates ovarian
      androgen production and inhibits the release of fatty acids from cells, both of which worsen
      PCOS-related issues. Although lower carbohydrate diets may be helpful, research from other
      populations with or at risk of type 2 diabetes suggests that prior PCOS studies may have set
      insufficient carbohydrate reduction targets. The investigators propose that a very-low
      carbohydrate diet may be needed to especially benefit women with PCOS, as greater
      carbohydrate reduction should have a larger impact on androgen levels and weight loss. Thus,
      the goal of this proposal is to pilot test our existing very-low carbohydrate diet
      intervention, adapted for women with PCOS.
    

Intervention name(s): diet and lifestyle program
Intervention type(s): Behavioral
Intervention description(s): Participants will be taught how to follow a very low carbohydrate, ketogenic diet, become more physically active, and get adequate sleep. They will also be taught taught about positive affect skills (such as gratitude, positive reappraisal, and personal strengths) and mindfulness (general mindfulness and mindful eating).
Intervention model: Single Group Assignment
Intervention model description: Participants will be taught how to follow a very low carbohydrate, ketogenic diet, become more physically active, and get adequate sleep. Behavioral: positive affect informational materials. They will also be taught about positive affect skills, such as gratitude, positive reappraisal, and personal strengths, in addition to information about mindfulness and mindful eating techniques.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: nutrition
Automated Insulin Delivery Amongst Pregnant Women With Type 1 Diabetes
Condition: Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      Evaluation of the biomedical and psychosocial impact of automated Closed-Loop (Artificial
      Pancreas) insulin delivery in women with type 1 diabetes during pregnancy
    

Detailed description: 
      An open-label, multi-centre, randomized, two-arm parallel group trial comparing automated
      closed-loop and standard insulin delivery.

      124 pregnant women between 18 and 45 years of age with Type 1 Diabetes of at least 12 months'
      duration on standard insulin delivery (CSII or MDI) will be recruited through outpatient
      antenatal diabetes clinics. Women fulfilling the eligibility criteria will be randomized to
      automated insulin delivery (AiD) or to continue standard patient-directed insulin delivery
      (CSII or MDI) without AiD. The study will take place within the home and NHS antenatal
      clinical settings.

      Additional blood samples for the research will be obtained at the 24th and 34th week of
      pregnancy and questionnaires will also be completed by the participant at the 34th week of
      pregnancy. Following this we will collect information on the birth.

      25 of the woman randomised to the closed loop insulin delivery system will also be
      interviewed to gain more information on, among other things, their existing diabetes
      management practices, everyday work and family lives and their experience with the device.
    

Intervention name(s): Automated closed-loop insulin delivery (AiD); A standard insulin delivery system
Intervention type(s): Device; Device
Intervention description(s): Closed-loop systems are designed to deliver insulin in response to CGM glucose levels and may help to improve glucose control above and beyond what is currently achievable using insulin pumps, injections and CGM without AiD.; Self-directed insulin delivery for pregnant women with T1D, which is insulin pump or MDI.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: An open-label, multi-centre, randomized, two-arm parallel group trial
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Type 1 Diabetes
Evaluation of Whether Deferiprone Affects QT Interval in Healthy Subjects
Condition: Prolonged QTc Interval
Study type: Interventional
Phase: Phase 4

Summary: 
      Randomized, single-dose, double-blind, placebo and active controlled, four-period crossover
      study to evaluate the effect of deferiprone on QTc prolongation after administration of a
      single therapeutic (33 mg/kg) and supratherapeutic(50 mg/kg) oral doses of deferiprone in
      healthy volunteers as compared to placebo treatment.
    

Detailed description: 
      Post-marketing study to evaluate the effect of deferiprone and deferiprone 3-O-glucuronide on
      QTc prolongation in healthy volunteers after administration of a single therapeutic (33
      mg/kg) and supratherapeutic (50 mg/kg) oral dose of deferiprone and moxifloxacin (Avelox®).
    

Intervention name(s): Deferiprone; deferiprone matching placebo tablets; moxifloxacin; placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Ferriprox 500 mg tablets; deferiprone matching placebo tablets; Active control; moxifloxacin-matching placebo
Other intervention name(s): Ferriprox; L1; Placebo; Avelox
Intervention MeSH terms: Moxifloxacin; Deferiprone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Ferriprox®; LI; DFP; Deferiprone; Healthy Volunteers
Comparison of Two Neuromuscular Monitors
Condition: Neuromuscular Monitoring
Study type: Observational

Summary: 
      Different neuromuscular monitors may be available in the same care structure. Two different
      monitors are available in the investigators' institution in the operative room and the
      recovery room. However, these two monitors have not been compared and may not be
      interchangeable. Starting the monitoring with one device and continuing with another device
      may be inaccurate and may lead to inadequate medical decisions. The investigators therefore
      conducted this observational study to compare the two devices available in our institution.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients undergoing vascular surgery under general anesthesia and requiring neuromuscular
        blockade for intubation or surgery
Assessment of an Oral Influenza B Vaccine Tablet (VXA-BYW.10) Following Single Dose Administration in Healthy Adults
Condition: Seasonal Influenza B
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase 1, single-center, placeb-controlled, double-blind study. The purpose of this
      study is to determine the safety and immunogenicity of an oral vaccine tablet to prevent
      seasonal influenza B tested at two dose levels (low and high dose). The study will enroll 27
      subjects in the low dose cohorts (3 sentinel open label subjects followed by 24 subjects
      (randomized 2:1 to vaccine vs placebo, respectively). Subsequently, 27 subjects will be
      enrolled in the high dose cohort in a similar manner as to the low dose cohort. Safety and
      immunogenicity will be evaluated at Day 28. Long term safety follow-up will be evaluated
      through 1 year post vaccination.
    

Detailed description: 
      The study will enroll 54 subjects in four cohorts. All subjects will receive a single
      administration of VXA-BYW.10 at a low dose, a high dose or placebo.

      Two sentinel groups will enroll 3 subjects each in an open-label manner (Cohorts 1 and 3) to
      receive VXA-BYW.10 prior to enrolling either of the randomized, controlled cohorts (Cohorts 2
      and 4). Within the double-blinded Cohorts (2 and 4), placebo subjects will receive the same
      number of tablets as the vaccine subjects in that Cohort. Subjects will be enrolled and dosed
      in the low dose groups prior to initiation of dosing in the high dose group.

      Cohort 1: 3 subjects at low dose; Cohort 2: 16 subjects at low dose and 8 placebo; Cohort 3:
      3 subjects at high dose; Cohort 4: 16 subjects at low dose and 8 placebo

      Subjects will be followed for 28 days post vaccination for preliminary immunogenicity.
      Subjects will continue to be followed for 1 year post-vaccination for long term safety.
    

Intervention name(s): VXA-BYW.10 (Low Dose) Oral Vaccine; VXA-BYW.10 (High Dose) Oral Vaccine; Placebo Tablets
Intervention type(s): Biological; Biological; Other
Intervention description(s): Enteric coated tablet for oral delivery; Enteric coated tablet for oral delivery; Enteric coated tablet for oral delivery
Other intervention name(s): Influenza B (Low Dose) Oral Vaccine Tablets; Influenza B (High Dose) Oral Vaccine Tablets
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Influenza B