Kornimate/medical-research-clean huggingface dataset:
cgm academy for youth with type 1 diabetes

Conditions: Type1 Diabetes

Summary: the goal of this randomized clinical trial is to compare the effects of a virtual education curriculum in blood glucose variation of youth with type 1 diabetes wearing continuous glucose monitoring (cgm) device. the main questions the study aims to answer are: * do participants undertaking the proposed curriculum present improved glucose variation than participants of standard education? * explore relationships between participant's glycemic outcomes with diabetes distress, diabetes family responsibilities, and number of hours of diabetes education. participants in the intervention group will: * receive an interactive workbook with problem-based learning scenarios and video links about cgm and glucose management strategies. * participate in four in-depth online group sessions with diabetes care and education specialists * complete questionnaires three times: at the time of study enrollment, week 4 and 6 months. participants in the comparison group will: * receive standard education provided to all patients at chla * complete questionnaires three times: at the time of study enrollment, week 4 and 6 months.

youth with type 1 diabetes (t1d) are at increased risk for kidney failure, vision loss, heart disease, and premature mortality due to challenges with glycemic excursions. continuous glucose monitoring (cgm) systems represent an important advance in diabetes technology with significant advantages over self-monitored blood glucose and the potential to optimize glycemic management. despite these advances, youth with t1d, including patients at children's hospital los angeles (chla), fail to achieve recommended glycemic targets, highlighting the opportunity for testing innovative diabetes education programs aimed at increased technology uptake such as the cgm academy intervention.

Eligibility criteria:
inclusion criteria: * current age of 8-18 years, age group eligible for cgm therapy with dexcom g6 and g7 * t1d duration ≥6 months, as insulin adjustments during honeymoon stage differs from establishedt1d * able to speak, read, and write english or spanish * smartphone compatible with dexcom g6 and g7application * ability to participate in virtual visits exclusion criteria: • known history of medical adhesive allergies

Keywords: continuous glucose monitoring glycemic control diabetes education type1 diabetes
efficacy and safety of bulevirtide (blv) therapy in hdv chronic hepatitis (chd) in italy

Conditions: Hepatitis D

Summary: spontaneous, pharmacological observational, no-profit, retrospective, multi-center. this study was designed to get a "real-life" snapshot across several italian hepatology centers. all hdv patients are followed up according to easl 2017 guidelines. this allows uniformity on the indication for antiviral treatment and management of that antiviral therapy. no off-label medications are used. all data are retrievable from the patient's medical record. in addition, clinical and biochemical data from patients at month 0, 1, 2, 4, 6 and 12 of treatment, and otherwise within the study period, will be collected retrospectively/longitudinally. the primary objective of the study is to describe the virological response to blv in all patients starting blv therapy, defined as a \>2 log decline in hdv-rna or undetectable hdv-rna (using the robogene 2.0 quantitative kit, llq \<6 iu/ml) at month 12 of therapy. all patients with active hdv chronic hepatopathy (quantifiable hdv-rna) who initiated treatment with blv 2 mg/day during the study period at the s.c. gastroenterology and hepatology (fondazione irccs ca' granda ospedale maggiore policlinico) and at participating centers, and who met the inclusion criteria and none of the exclusion criteria.


Eligibility criteria:
inclusion criteria: * 18 years of age or older * chronic hepatitis delta * compensated cirrhosis hdv related * bulevertide 2 mg/day within december 15, 2020, to december 31, 2022 exclusion criteria: - hdv-related decompensated cirrhosis (cpt ≥7)
coolsculpting system

Conditions: Body Fat Disorder

Summary: evaluate the safety and efficacy of multiple, simultaneous coolsculpting cycles for the purpose of non-invasive fat reduction.


Eligibility criteria:
inclusion criteria * subject (healthy volunteer) has read and signed the study written informed consent form. * male or female ≥ 22 years and ≤65 years of age. * subject has clearly visible fat in one or more areas on the torso (abdomen, flank, back fat, bra fat), which in the investigator's opinion, may benefit from the treatment. * subject has not had weight change exceeding 5% of body weight in the preceding month. * subject agrees to maintain his/her weight (i.e., within 5%) by not making any major changes in their diet or exercise routine during the study. * subject has a bmi ≤ 30 as determined at screening. * subject agrees to have photographs taken of the treatment area(s) during the scheduled time periods. exclusion criteria * subject has had a recent surgical procedure in the area of intended treatment. * subject has had an invasive fat reduction procedure (e.g., liposuction, mesotherapy) in the area of intended treatment. * subject has had a non-invasive fat reduction and/or body contouring procedure in the area of intended treatment within the past 12 months. * subject needs to administer or has a known history of subcutaneous injections into the area of intended treatment (e.g., heparin, insulin) within the past month. * subject has a known history of cryoglobulinemia, paroxysmal cold hemoglobinuria, or cold agglutinin disease. * subject has a known sensitivity to cold, such as cold urticaria, raynaud's disease, chilblains (pernio), or any known condition with a response to cold exposure that limits blood flow to the skin. * subject has a history of bleeding disorder or is taking any medication that in the investigator's opinion may increase the subject's risk of bruising. * subject is taking or has taken diet pills or supplements within the past month. * subject has any dermatological conditions, such as moderate to excessive skin laxity, or scars in the location of the treatment sites that may interfere with the treatment or evaluation (stretch marks is not an exclusion). * subject has an active implanted device such as a pacemaker, defibrillator, or drug delivery system * subject has a history of hernia in the area(s) to be treated. * subject is pregnant or intending to become pregnant during the study period (in the next 8 months). * subject is lactating or has been lactating in the past 6 months. * subject is unable or unwilling to comply with the study requirements. * subject is currently enrolled in a clinical study of any unapproved investigational drug or device. * any other condition or laboratory value that would, in the professional opinion of the investigator, potentially affect the subject's response or the integrity of the data or would pose an unacceptable risk to the subject.
cryoablation of the retrograde fast pathway as treatment for avnrt

Conditions: Atrioventricular Node Arrhythmia

Summary: in this study a new technique for ablation in atrioventricular nodal reentrant tachycardia using cryo-energy will be studied in cases where the standard approach has higher risk.

atrioventricular nodal reentrant tachycardia (avnrt) is the most common cause of fast heartbeats in young people. people with avnrt have two pathways within the heart, the fast pathway (fp) and slow pathway (sp). a treatment for avnrt is ablation (burning or freezing) of the sp. this can be done with either radiofrequency or cryo-energy. a complication which occurs in 1% of cases is av block (avb), meaning the person needs a pacemaker. slow pathway ablation is a problem in people when the electrocardiogram (ecg) shows a long pr interval, with greater rates of avb. this accounts for 5% of avnrt cases. a possible solution is to treat the fp with cryo-energy and leave the sp intact. this pilot study aims to show this is safe and effective.

Eligibility criteria:
inclusion criteria: * documented supraventricular tachycardia (svt) * planned to undergo electrophysiology (ep) study and ablation * pr interval on ecg \ 220ms (group 2) exclusion criteria: * pregnancy * age \<18 years * inability to provide consent * high likelihood of tachycardia mechanism other than avnrt (e.g. pre-excitation on surface ecg, atrial tachycardia)

Keywords: avnrt cryoablation pr interval
multimedia self-management intervention for lung cancer surgery family caregivers and patients

Conditions: Caregiver; Stage I Lung Cancer AJCC v7; Stage IA Lung Cancer AJCC v7; Stage IB Lung Cancer AJCC v7; Stage II Lung Cancer AJCC v7; Stage IIA Lung Cancer AJCC v7; Stage IIB Lung Cancer AJCC v7; Stage III Lung Cancer AJCC v7; Stage IIIA Lung Cancer AJCC v7; Stage IIIB Lung Cancer AJCC v7

Summary: this randomized phase iii trial studies how well a multimedia self-management intervention works in preparing family caregivers and patients with stage i-iii lung cancer for lung cancer surgery. the multimedia self-management intervention, preparing for your lung cancer surgery, is a nurse-led, caregiver-based, multimedia intervention that may improve patient recovery after surgery, lower caregiving burden, and improve distress and quality of life.

primary objectives: i. test the effects of the multimedia self-management (msm) intervention on family caregivers (fcg) outcomes and cancer support services use at discharge and 3-month post-discharge, comparing intervention and attention control groups. ii. test the effects of the msm intervention on patient outcomes and healthcare resource use at discharge and 3-months post-discharge, comparing intervention and attention control groups. iii. test the effects of the msm intervention on outcome mediators at discharge and 3-months post-discharge, comparing intervention and attention control groups. secondary objectives: i. explore moderators (age, sex, marital status, caregiver relationship to patient, caregiver employment status, co-morbidities) of fcg and patient outcomes and reciprocal relationships. ii. determine, through exit interviews, participant's experience with the msm intervention. outline: patients are randomized to 1 of 2 groups. group i: patients and fcgs receive the msm intervention consisting of videos, a handbook, and research nurse coaching over 40-60 minutes, approximately 3-7 days before surgery and within 24 hours of planned discharge. patients and fcgs also receive research nurse support by telephone (separate sessions for fcgs and patients) over 20-30 minutes at 2 and 7 days, and 2 months post-discharge. group ii: patients and fcgs receive attention control intervention consisting of videos (american cancer society video on "clinical trials"), american cancer society print materials, and assistance from a clinical research associate (cra) approximately 3-7 days before surgery and within 24 hours of planned discharge. patients and fcgs also receive assistance from cras via telephone calls at 2 and 7 days, and 2 months post-discharge.

Eligibility criteria:
family caregiver inclusion criteria: * a family member or friend identified by the patient as being the primary care provider before and after surgery * a patient/care recipient enrolled in the study * age 21 years or older * able to read or understand english patient inclusion criteria: * diagnosis of stage i-iii non-small cell lung cancer * scheduled to undergo surgery for treatment * a family caregiver enrolled in the study * age 21 years or older * able to read or understand english.
immunogenicity, safety of measles-mumps-rubella-varicella vaccine (memuru-oka) compared to priorix™ given with varilrix™

Conditions: Varicella; Rubella; Measles; Mumps

Summary: as measles-mumps-rubella (mmr) vaccination is established as routine childhood practice in most industrialised countries and varicella vaccination is now being introduced in many countries during the second year of life, a combined measles-mumps-rubella-varicella vaccine was developed for administration convenience and improved compliance to vaccination. to account for situations where children have received a first dose of mmr vaccine without varicella, this study will evaluate the effect of the combined measles-mumps-rubella-varicella vaccine given in place of the second dose of mmr vaccine. a second dose of the monovalent varicella vaccine will be given to all children participating to this trial since there is a current debate on the need of a second dose to induce a full protection against varicella.


Eligibility criteria:
inclusion criteria: * children must be healthy to participate exclusion criteria: * immunosuppressive (including hiv) conditions, allergic diseases, neurological disorders, known anaphylactic reaction to mmr vaccine, and fever (axillary temperature ³ 37.5°c at the time of vaccination) are excluding factors. * children must have received one dose (but not more) of mmr at least 6 weeks before entering the study. * they must not receive or have received other non-registered drug or vaccine within 30 days prior to study start, or immunosuppressants for more than 14 days. * immunoglobulins or any blood products are prohibited during the 6 months before and during the study, as well as vaccine other than that foreseen by the protocol, 30 days before until 56 days after vaccination. * children must not have been vaccinated against varicella. * they must not have had measles, mumps, rubella or varicella, or have been exposed to those diseases within 30 days prior to study start. * new-born infants (\< 5 weeks of age), pregnant women without previous exposure to chickenpox, and immunodeficient persons cannot live in the same household as the vaccinated child.
evaluation of the "blue halo coil catheter" for patients with prostatic obstruction

Conditions: Urinary Retention

Summary: the investigators will study a device for men in urinary retention secondary to benign prostatic hyperplasia, bph ,who are catheter dependent or who have a post void residual \> 350cc. the hypothesis is that the device will allow these participants to return to volitional voiding with a post void residual \<75 cc.

the indication for use of the blue halo coil catheter is to facilitate bladder drainage in adult male patients with urinary retention due to benign prostatic hyperplasia. the device is inserted for temporary use up to 28 days. study participants will have a history of foley catheter use or self-catheterization to drain their bladder.participants may include men in urinary retention with no prior intervention. the hypothesis is that the blue halo coil catheter will reduce the post void residual to \<75 cc with volitional voiding. the blue halo coil catheter is comprised of a coiled retention portion with a guidewire accommodating tip, a short prostate catheter segment, and a pusher/delivery catheter segment, that when left in place allows for the temporary collection of urine prior to conversion to short segment without an external collection device. the tip of the blue halo coil catheter utilizes a horizontal coil retention device. a monofilament suture is attached to the prostate catheter segment to allow for ease of positioning and removal. the suture also allows for repositioning should the device slip back into the bladder.

Eligibility criteria:
inclusion criteria: * male subjects \> 50 years of age * able to provide consent * participants in urinary retention with post void residual \> 350 cc * urinary retention is due to bph with a prostate volume \> 50cc or a prostatic urethral length of 5+ cm * subjects with a psa \> 4 ng/ml and a psa density of 0.1 or less * subjects on alpha- blocking drugs or 5-alpha-reductase inhibitor drugs may be included exclusion criteria * inability to undergo bladder catheterization ( i.e. urethral stricture) * presence of gross hematuria * lack of cognitive ability to give consent or keep appointments * history of prostate cancer * subject with a psa \> 4 ng/ml and a psa density of \> 0.1 will require prostate biopsy to rule out prostate cancer in order to be considered for study enrollment * a subject with a prostate nodule will require biopsy to exclude cancer diagnosis * subject with a psa \> 10 ng/ml * subject taking lhrh analogs or anti-androgen drugs
spi-1005 for the treatment of meniere's disease (open label)

Conditions: Meniere's Disease; Ménière's Disease

Summary: study of the safety of open-label spi-1005 400 mg bid treatment in adults with meniere's disease (md) for 6 or 12 months to support chronic or chronic intermittent use.


Eligibility criteria:
inclusion criteria: * adult males/females, 18-75 years of age at the time of enrollment. * diagnosis of probable or definite meniere's disease by aao-hns amended 2015 criteria. * at least two of three active symptoms (fluctuating hearing; tinnitus; aural fullness; vertigo or dizziness) of meniere's disease, within 3 months of study enrollment. * type a tympanogram at screening. * air conduction thresholds ≤ 90 db at all tested frequencies (250-8000 hz) in both ears. * subject is willing and able to provide informed consent and perform study procedures and assessments per protocol. * reproductive requirements exclusion criteria: * current, or within 60 days prior to study enrollment, use of iv or intratympanic ototoxic medications such as chemotherapy including cisplatin, carboplatin, or oxaliplatin; aminoglycoside antibiotics including gentamicin, amikacin, tobramycin, kanamycin, or streptomycin; or loop diuretics including furosemide. * history of otosclerosis or vestibular schwannoma. * history of significant middle ear or inner ear surgery in the affected ear. * conductive hearing loss with air-bone gap ≥15 db, otitis media, or mixed hearing loss. * significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, neurological, or psychiatric disease. * current use or within 30 days prior to study enrollment systemic steroids. * current use or within 7 days prior to study enrollment intratympanic steroids. * hypersensitivity or idiosyncratic reaction to compounds related to ebselen or excipients. * female patients who are pregnant or breastfeeding. * participation in another investigational drug or device study within 30 days prior to study consent. * participant resides more than 100 miles from the study site.

Keywords: ebselen hearing loss tinnitus vertigo dizziness spi-1005
virtual reality for parent training intervention

Conditions: Attention-Deficit/Hyperactivity Disorder (ADHD)

Summary: previous research has shown how parental responses can affect adhd symptoms by triggering dysfunctional cyclic processes. therefore, it may be useful within rehabilitative treatments to include parent training (pt). recent literature data have demonstrated the potential of using virtual reality in the rehabilitation of children with adhd. no study has been conducted on the use of virtual reality (vs) within a pt program. it is possible to hypothesize that virtual reality, by providing a controlled environment can help the parent improve his or her ability to self-control and perceive the child's difficulties. this allows the parent's empathizing skills to be implemented and reinforces the educational techniques learned during the parent training intervention.

the investigators designed a single-blind, randomized, controlled study on adhd patients and their parents, with the aim of evaluating the effects of virtual reality support during pt program compared to traditional pt sessions.

Eligibility criteria:
inclusion criteria: * patients diagnosed with adhd, according to diagnostic and statistical manual of mental disorders (dsm-5) criteria; * age including 6 to 10 years; * subjects with iq \>70; * signed informed consent and the availability of at least one family member to participate in the diagnostic/therapeutic process. exclusion criteria: * important comorbidities with psychiatric or neurological syndromes (e.g., epilepsy, known genetic syndromes, infantile cerebral palsy, sensory deficits); * subjects under the age of 6 years; * subjects older than 10 years of age; * subjects diagnosed with intellectual disability (iq ≤70); * informed consent not signed and/or unavailability of at least one family member to participate in the diagnostic/therapeutic process.
multidetector raw ct as a single tool in the setting of ischemic stroke

Conditions: Ischemic Stroke

Summary: this is a prospective study including acute ischemic stroke patients aged 18 to 90. multidetector raw ct is performed in acute ischemic stroke patients. heart, neck vessels and brain arteries are studied during the same acquisition. results are compared with the standard methods including transesophageal echocardiography (tee), doppler ultrasound (dus) and mr angiography (mra) of neck vessels. the main criteria is the ability of ct to classify the stroke etiology correctly according to the toast classification in comparison with the standard methods.


Eligibility criteria:
inclusion criteria: * acute (\< 1 week) ischemic stroke patient aged 18 to 90 * informed consent obtained * presence of health insurance exclusion criteria: * pregnancy or absence of efficient contraceptive method * allergy * allergy to contrast material * asthma * renal failure (blood creatinine \> 130 µmoles/l, creatinine clearance \< 80 ml/mn according to cockroft method) * myeloma * hyperthyroidism (uncontrolled) * difficulties to synchronize ct to heart rhythm * contra-indication to tee or mri * absence or retirement of informed consent * absence of health insurance

Keywords: stroke, ischemic, etiology, toast, ct, multidetector
the effect(s) of sevelamer carbonate (renvela) on atherosclerotic plaque inflammation judged by fdg-pet scan

Conditions: Dialysis; Cardiovascular Disease; Atherosclerosis; Inflammation; Hyperphosphatemia

Summary: the hypothesis is that switching calcium based phosphate binders to sevelamer carbonate will be associated with less inflammation including less atherosclerotic plaque inflammation (inflammation of the vessel walls).


Eligibility criteria:
inclusion criteria: * a signed consent form; * male or female, 50 years or older; * diagnosed with end stage renal disease (esrd), on maintenance hemodialysis for at least three (3) months; * on calcium-based phosphate binders; * subject must be able to understand and provide informed consent; * no known contraindications to therapy with sevelamer carbonate. exclusion criteria: * any patient with a medical condition or taking any medications that would be contraindicated with the use of sevelamer carbonate, such as history of bowel obstruction; * history of severe allergic reactions to the study medication; * history of active infection (other than a simple respiratory tract infection) or acute gouty attack within 2 weeks prior to enrollment; * known serological positivity for human immunodeficiency virus (hiv), hepatitis b surface antigen (hbsag), or hepatitis c virus antibody (hcv ab) except dose with normal liver function tests (ast, alt, bilirubin, and alkaline phophatase) and no history of cirrhosis; * elevation of liver function tests at time of entry (aspartate aminotransferase (ast) and/or alanine aminotransferase (alt) \> 2 times the upper limit of normal); * history of drug, alcohol, or chemical abuse within 6 months prior to enrollment; * history of malignancy except those adequately treated, has completed treatment and clinically in remission for more than 6 month; adequately treated in-situ cervical carcinoma, or adequately treated basal or squamous cell carcinoma of the skin; * history of an inflammatory disease such as systemic lupus erythematosus (sle), rheumatoid arthritis or ulcerative colitis except those in remission for more than 6 months; * patients currently on sevelamer carbonate or sevelamer chloride or history of taking them for more than a week in the past three months; * patients receiving chronic anti-inflammatory therapy; * patients in whom fdg-pet/ct dual scans are contraindicated.