bioihbjkbjnl/mcl2 huggingface dataset:
Examining the Effectiveness of a Wait List Intervention for the Management of Adolescent Eating Disorders
Condition: Eating Disorders
MeSH terms: Feeding and Eating Disorders
Study type: Interventional

Summary: 
      The current application targets patient education and enablement, implementation of best
      practices, continuity of care, and an improvement model to improve efficiencies by
      investigating whether a brief targeted intervention prior to the first formal ED assessment
      is efficacious in altering outcome and treatment course.
    

Detailed description: 
      The Eating Disorder Program at the Children's Hospital of Eastern Ontario (CHEO) offers a
      continuum of treatment options to child and adolescent patients with eating disorders (EDs).
      Although our own funding has increased in recent years, so too have the number of referrals,
      which has resulted in lengthy wait times for therapeutic assessments by our team. The current
      application targets patient education and enablement, implementation of best practices,
      continuity of care, and an improvement model to improve efficiencies by investigating whether
      a brief targeted intervention prior to the first formal ED assessment is efficacious in
      altering outcome and treatment course. It is well known that early recognition and
      implementation of treatment as soon as possible after the onset of symptoms is protective in
      eating disorders and leads to better success rates and recovery (APA Treatment Guidelines for
      EDs). It is hoped that the outcome of this study will influence the way in which centers look
      to address the ongoing issue of lengthy wait times in hopes of offering cost-effective
      interventions that ultimately improve patient outcomes. By offering an added level of support
      to families whose referral has been initiated, we hope to ease the burden of primary care
      providers and increase their satisfaction as it relates to patient safety concerns and
      complex case management.
    

Intervention name(s): Psychoeducational Workshop and telephone support
Intervention type(s): Behavioral
Intervention description(s): The intervention involves completion of a single workshop (delivered by a psychiatrist and adolescent health physician), provision of psycho educational materials, and regular telephone support with a specially trained nurse-coordinator to parents of youth on our waiting list.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: anorexia nervosa; bulimia nervosa; EDNOS
Renal Considerations in the Heat Stress Recommendations (Aim2)
Condition: Hot Weather; Adverse Effect; Kidney Dysfunction; Kidney Injury; Hyperthermia; Dehydration
MeSH terms: Dehydration; Hyperthermia
Study type: Interventional

Summary: 
      An epidemic of chronic kidney disease is occurring in laborers who undertake physical work
      outdoors in hot conditions. The reason for this is largely unknown, but may be related to
      kidney dysfunction caused by increases in body temperature and dehydration that elicit
      oxidative stress and inflammation in the renal tubules. The purpose of this study is to
      determine whether hydration status modifies the development of renal oxidative stress and
      inflammation.
    


Intervention name(s): Fluid replacement; No fluid replacement
Intervention type(s): Procedure; Procedure
Intervention description(s): Participants will drink Gatorade Zero ad libitum, up to 1 cup every 15 minutes.; Participants will not be permitted to drink.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Study Evaluating the Efficacy of Nifedipine GITS - Telmisartan Combination in Blood Pressure Control.
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      Patients having uncontrolled or poorly controlled hypertension are at risk of experiencing
      cardiovascular events such as myocardial infarction or stroke. To reduce this risk an
      appropriate antihypertensive therapy should allow to reach a target blood pressure of less
      than 130/80 mmHg in order to maximise cardiovascular protection.The purpose of this study is
      to evaluate the efficacy in blood pressure control when anti-hypertensive therapy is
      initiated with a combination of low dose Nifedipine GITS and Telmisartan compared to a
      regimen starting with monotherapy before adding the other drug.The primary efficacy parameter
      will be the 24 hour mean systolic Blood Pressure on Ambulatory Blood Pressure Monitoring
      (ABPM) at 16 weeks of treatment compared to baseline
    


Intervention name(s): Nifidipine; Telmisartan; Nifedipine/Telmisartan
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Tablets 20 Mg daily for 4 weeks then combination therapy; Tablets 80 Mg daily for 4 weeks then combination therapy; 2 drugs (20 Mg Nifedipine/80 Mg Telmisartan) Combination therapy since the beginning
Intervention MeSH terms: Telmisartan; Nifedipine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Glycogen Metabolism in Children
Condition: Healthy
Study type: Interventional

Summary: 
      It is not fully understood in children how much of hepatic and muscle glycogen is used during
      a night and how they are replenished after a breakfast. This study aims to analyze the
      glycogen metabolism before and after an overnight sleep as well as after a breakfast in
      children between 8 and 12 years old.
    

Detailed description: 
      The aim of the study is to investigate if liver and muscle glycogen stores are depleted in
      children after overnight fasting and to what extend the stores are replenished with the
      intake of small breakfast.

      The study is a balanced incomplete crossover design. Participants (children between 8 and 12
      years old) have to be two periods of two days in the study. They will be randomized in 6
      arms, receiving either water, 1 serving of a small breakfast (Breakfast 1) or 2 servings of
      the small breakfast (Breakfast 2).

      An Interim Analysis after 9 completed subjects will be performed in order to calculate the
      total number of subjects needed to adequately power the Primary Endpoint.
    

Intervention name(s): Breakfast 1; Breakfast 2; Water
Intervention type(s): Other; Other; Other
Intervention description(s): Participant will receive Breakfast 1; Participant will receive Breakfast 2; Participant will receive water
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomized, controlled, balanced incomplete crossover design
Masking: None (Open Label)
Primary purpose: Basic Science
A Study of RO4917523 in Patients With Fragile X Syndrome
Condition: Fragile X Syndrome
MeSH terms: Fragile X Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      This multi-center, randomized, double-blind, placebo-controlled, parallel-group study will
      investigate the efficacy and safety of RO4917523 in adolescent and adult patients with
      fragile X syndrome. Patients will be randomized to receive oral doses of 0.5 mg or 1.5 mg of
      RO4917523, or matching placebo once daily. The anticipated time on study treatment is 12
      weeks.
    


Intervention name(s): Placebo; RO4917523 0.5 mg; RO4917523 1.5 mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): placebo to RO4917523 orally once a day for 12 weeks; 0.5 mg orally once a day for 12 weeks; 1.5 mg orally once a day for 12 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Human Phase I Absolute Bioavailability Study of PRT054021 in Healthy Male Volunteers
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a open label, single center, single oral dose, study of PRT054021, in healthy
      subjects.
    


Intervention name(s): Betrixaban
Intervention type(s): Drug
Intervention description(s): Single Oral dose 80 mg betrixaban and Single IV (15 ml) carbon 14 80 micrograms Betrixaban administered over 15 minutes, 2 hours after the oral dose
Intervention MeSH terms: Betrixaban
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Betrixaban; Healthy; Bioavailability
Pharmacological Treatment of Comorbid Alcohol and Marijuana Withdrawal and Dependence
Condition: Cannabis Dependence; Alcohol Dependence; Cannabis Use Disorder; Alcohol Use Disorder
MeSH terms: Marijuana Abuse; Alcoholism
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary aim of the supplemental study is to provide POC testing of aprepitant as a
      treatment for comorbid alcohol and cannabis dependence. The data analysis plan specified in
      the parent grant will likewise be applied to the supplemental project to test for effects of
      aprepitant vs placebo on measures of alcohol and cannabis use and protracted withdrawal. The
      primary hypothesis is that subjects treated with aprepitant will have significantly less
      alcohol and marijuana use than subjects treated with placebo.
    

Detailed description: 
      Consistent with the scope and methods of the parent grant, this was a randomized,
      double-blind, placebo-controlled, parallel groups, Phase II, single-site, 8-week clinical
      trial of aprepitant 125 mg/d or placebo. Participants were 20 outpatients seeking treatment
      for concurrent alcohol and cannabis dependence. All participants received weekly
      protocol-specific counseling. Research assessments occurred weekly through the treatment
      phase of the 8-week study. Post treatment follow-up assessments occurred at Weeks 9 and 12.
    

Intervention name(s): aprepitant; Placebo; Manual-guided behavioral counseling
Intervention type(s): Drug; Drug; Behavioral
Intervention description(s): 125 mg daily for 8 weeks.; Placebo daily for 8 weeks.; Standardized manual-guided behavioral counseling performed 1 time per week for 8 weeks in conjunction with study drug or placebo.
Other intervention name(s): Emend; Manual-guided therapy
Intervention MeSH terms: Aprepitant
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cannabis Treatment; Alcohol Treatment; Alcohol-Related Disorders; Cannabis-Related Disorders; Substance-Related Disorders; Emend; NK1 receptor antagonist; Alcohol; Cannabis; aprepitant
Neuromodulation With Low Frequency-Pulsed Electromagnetic Fields
Condition: Electromagnetic Fields; Neuronal Plasticity; Transcranial Magnetic Stimulation
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Non-depolarizing magnetic fields, like Low Frequency-Pulsed Electromagnetic Fields (LF-PEMFs)
      have shown the ability to modulate living structures, principally by influencing synaptic
      activity and ion channels on cellular membranes. Recently, the CTU Mega 20 device was
      presented as a molecular accelerator, using energy up to 200 Joules and providing high-power
      (2 Tesla) pulsating fields with a water-repulsive (diamagnetic) action and tissue
      biostimulation. The investigators tested the hypothesis that LF-PEMFs could modulate
      long-term corticospinal excitability in healthy brains by applying CTU Mega 20®. Ten healthy
      subjects without known neurological and/or psychiatric diseases entered the study. A
      randomized double-blind sham-controlled crossover design was employed, recording TMS
      parameters (amplitude variation of the motor evoked potential as index of cortical
      excitability perturbations of the motor system) before (pre) and after (post +0, +15, +30
      min) a single CTU Mega 20 session on the corresponding primary right-hand motor area, using a
      real (magnetic field = 2 Tesla; intensity = 90 J; impulse frequency = 7Hz; duration = 15
      minutes) or sham device. A two-way repeated measures ANOVA with TIME (pre, post +0, +15, +30
      min) and TREATMENT (real vs sham stimulation) as within-subjects factor was applied.
    


Intervention name(s): CTU Mega 20 real device; CTU Mega 20 sham device
Intervention type(s): Device; Device
Intervention description(s): The CTU Mega 20 diamagnetic acceleration system discharges high-field magnetic impulses (with a duration of 5 ms and a period of 1000 ms), generating a magnetic field up to 2 Tesla, with a frequency of 7500 Hz in a volume of approximately 27 cm3.; A CTU Mega 20 sham device (with an identical appearance to that of the real device) to avoid treatment identification by the patient or experimenter was used. Of course, the application of this sham device did not provide any magnetic field.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
A Single Dose Of GSK189075 Taken By Mouth Containing Small Amounts Of Radioactivity Studied In Healthy Male Volunteers
Condition: Type 2 Diabetes Mellitus; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will look at the relative amounts of GSK189075 that are found in samples of blood,
      urine, and feces of healthy male volunteers. Results of the study will be used to understand
      how the drug is converted in the body and how it is eliminated.
    


Intervention name(s): Radiolabelled GSK189075
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: metabolite profiling; excretion,; radioactivity,; pharmacokinetic,; mass balance,
Infliximab for Treatment of Axial Spondyloarthritis (P05336 AM1)
Condition: Ankylosing Spondylitis; Axial Spondyloarthritis
MeSH terms: Spondylitis; Spondylarthritis; Spondylitis, Ankylosing; Axial Spondyloarthritis
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of this study was to assess the proportion of participants in the
      infliximab plus naproxen arm versus the placebo plus naproxen arm, in a population of
      participants with moderate-to-severe active axial spondyloarthritis and disease duration of
      ≤3 years, who achieve the Assessment in Ankylosing Spondylitis (ASAS) partial remission
      criteria.
    

Detailed description: 
      In the 28-week treatment phase, participants were randomized to receive either infliximab
      plus naproxen or placebo plus naproxen.

      After 28-weeks of treatment, participants that achieved partial remission in the treatment
      phase were randomized to continued treatment with naproxen or to receive no treatment and
      were followed for an additional 24 weeks (follow-up phase).
    

Intervention name(s): Infliximab; Placebo; Naproxen
Intervention type(s): Drug; Drug; Drug
Other intervention name(s): Remicade; SCH 215596; Naprosyn
Intervention MeSH terms: Infliximab; Naproxen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Norepinephrine to Prevent Hypotension in Ceasrean Delivery
Condition: Hypotension; Cesarean Section Complications
MeSH terms: Hypotension
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will be conducted on 40 healthy women having spinal anesthesia for elective
      cesarean delivery in the operating rooms at Menoufia university hospital.
    

Detailed description: 
      Informed written consent will be taken from all subjects included in the study after approval
      of the study by the local ethical committee.

      All subjects will be subjected to thorough history taking with risk factors, medical
      histories, general clinical examination, local clinical examination, laboratory
      investigations as complete blood count and coagulation profile.

      Standardized anesthetic care will be provided according to institutional standards, which
      include fasting, antacid premedication and noninvasive hemodynamic monitoring After arrival
      in the operating room, patients will be positioned supine with left lateral tilt, pulse
      oximeter, ECG leads, non-invasive blood pressure cuff and cardiometry leads (4 surface ECG
      electrodes is attached to the left side of the neck and the lower thorax (approximately at
      the level of the xiphoid process) will be attached to patient for monitoring of blood
      pressure (bp), heart rate, fluid responsiveness (thoracic volume variations and stroke volume
      variations), cardiac index and systemic vascular resistance and values will be recorded as a
      baseline and every 10 minutes after intrathecal injection.

      10 ml/kg/hr lactated ringer solution will be infused to all patients through an 18 gauge
      intravenous cannula for 30 minutes as a preload before spinal anesthesia then reduced to
      maintenance infusion of 6 ml/kg/hr.

      Patients will be then placed in sitting position. After skin disinfection and skin
      infiltration with lidocaine 1%, spinal anesthesia will be performed with 2ml 0.5% hyperbaric
      bupivacaine (10 mg) in addition to 0.5 ml fentanyl (25 μg) at L3-L4 or L4-L5.

      The patient will be then returned to the left-tilted supine position. The study drug regimen
      will be started immediately after intrathecal injection.
    

Intervention name(s): Norepinephrine bolus; cardiometry; Norepinephrine infusion
Intervention type(s): Drug; Device; Drug
Intervention description(s): 5 microgram bolus therapy; cardiac output, stroke volume and fluid responsiveness monitoring; 2.5 microgram/min infusion
Intervention MeSH terms: Norepinephrine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary purpose: Prevention
Keywords: hypotension; norepinephrine
The Immuno-Response to Primary Cryotherapy for the Treatment of Prostate Cancer
Condition: Recurrent Prostate Cancer; Stage I Prostate Cancer; Stage IIA Prostate Cancer; Stage IIB Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This randomized pilot phase I trial studies how well sargramostim after cryotherapy works in
      treating patients with prostate cancer. Biological therapies, such as sargramostim, use
      substances made from living organisms that may stimulate the immune system in different ways
      and stop tumor cells from growing. Cryosurgery, also known as cryotherapy, kills tumor cells
      by freezing them. Giving sargramostim after cryotherapy may work better in treating prostate
      cancer.
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. Determine an unknown normal immune response (T cell and B cell) to post-cryotherapy
      treatment for prostate cancer.

      II. Detect the altered immune response (T cell and B cell) post-GM-CSF (sargramostim)
      response and post-cryotherapy for the prostate cancer.

      Patients are randomized to 1 of 2 treatment arms.

      ARM I (TREATMENT): Patients undergo cryotherapy on day 0 and receive sargramostim
      subcutaneously (SC) on days 1, 3, 5, 8, 10, and 12.

      ARM II (CONTROL): Patients undergo cryotherapy on day 0.

      After completion of study treatment, patients are followed up for 6 months.
    

Intervention name(s): cryotherapy; sargramostim
Intervention type(s): Procedure; Biological
Intervention description(s): Undergo cryotherapy; Given subcutaneously
Other intervention name(s): GM-CSF; Leukine; Prokine
Intervention MeSH terms: Sargramostim
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Drug-Drug Interaction Study To Investigate The Potential For Multiple Doses Of Palbociclib (PD-0332991) To Alter The Pharmacokinetics Of Oral Midazolam In Adult Healthy Women of Non-Childbearing Potential.
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a drug-drug interaction study to compare the pharmacokinetics of a 2 mg oral dose of
      midazolam in adult healthy women of non-childbearing potential when administered alone and
      when administered along with 8 daily 125 mg doses of PD-0332991. Volunteers will be
      randomized to one of two sequences. Volunteers in sequence 1 will receive midazolam alone in
      treatment period 1, followed by multiple dose PD-0332991 and midazolam in treatment period 2.
      Volunteers randomized to sequence 2 will receive multiple dose PD-0332991 and midazolam in
      treatment period 1, and following a washout period of no less than 14 days they will receive
      midazolam alone in treatment period 2.
    


Intervention name(s): Midazolam; PD-0332991; Midazolam; PD-0332991
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Treatment A includes a single 2 mg oral dose of midazolam alone. Treatment B includes a single 2 mg oral midazolam dose on day 7 immediately after the day 7 PD-0332991 dose.; Treatment B includes 8 daily 125 mg oral doses of PD-0332991.; Treatment B includes a single 2 mg oral midazolam dose on day 7 immediately after the day 7 PD-0332991 dose.
Treatment A includes a single 2 mg oral dose of midazolam alone.; Treatment B is made up of 8 daily 125 mg oral doses of PD-0332991.
Intervention MeSH terms: Palbociclib; Midazolam
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: PD-0332991; Midazolam; Drug-Drug Interaction Study; Healthy Adult Volunteer
CARATKids: Italian Validation of Asthma and Allergic Rhinitis Control Test in Children
Condition: Allergic Rhinitis; Asthma
MeSH terms: Rhinitis; Asthma; Rhinitis, Allergic
Study type: Observational

Summary: 
      This project is an observational study for the Italian language validation of the CARATKids
      questionnaire investigating the asthma and coexisting allergic rhinitis control in children.
      113 patients with concomitant asthma and allergic rhinitis followed up from at least 3 months
      will be enrolled for the validation process at outpatient clinic of Pediatric Allergology &
      Pulmonology (PAP) of Respiratory Disease Research Center (RDRC) within the Institute of
      Biomedicine and Molecular Immunology (IBIM) of the National Research Council (CNR) of Palermo
      (RDRC-IBIM CNR), Italy.

      The study will be completed in two medical examination, within 3-6 weeks of each other.

      CARATKids questionnaire, VAS (Visual Analogic Scale) and C-ACT (Children Asthma Control Test)
      will be filled by each patient.

      The main outcome is the Italian language validation of the CARATKids questionnaire
      investigating the coexisting asthma and allergic rhinitis control in children.
    


Intervention name(s): CARATKids Questionnaire
Intervention type(s): Other
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        113 patients with concomitant asthma and allergic rhinitis followed up from at least 3
        months will be enrolled for the validation process at outpatient clinic of Pediatric
        Allergology & Pulmonology (PAP) of Respiratory Disease Research Center (RDRC) within the
        Institute of Biomedicine and Molecular Immunology (IBIM) of the National Research Council
        (CNR) of Palermo (RDRC-IBIM CNR), Italy.
      
Keywords: Allergic Rhinitis; Asthma; Children; Control