Kornimate/medical-research-clean huggingface dataset:
"embolization before ablation of renal cell carcinoma (embarc)"

Conditions: Renal Cell Carcinoma (RCC)

Summary: multi-center, single arm, prospective trial to estimate safety, feasibility, technical outcomes, and clinical outcomes of percutaneous cryoablation with neo-adjuvant trans-arterial embolization of the tumor in patients with t1b renal cell carcinoma. continuous safety monitoring will be performed with stopping rules for patient accrual or study continuation.


Eligibility criteria:
inclusion criteria: 1. aged ≥18 years 2. solid renal mass consistent with rcc on either ultrasound, mri, or ct 3. longest tumor diameter measures 4.1-7cm 4. tumor stage t1bn0m0 without vascular invasion, adenopathy, or distant metastatic disease 5. for females of reproductive potential: use of highly effective contraception for at least 1 month prior to enrollment and agreement to use such a method during study participation 6. provision of signed and dated informed consent form 7. stated willingness to comply with all study procedures and availability for the duration of the study exclusion criteria: 1. pregnancy 2. severe renal insufficiency with an estimated glomerular filtration rate (egfr) \<30 3. renal cell carcinoma as part of a syndrome 4. horseshoe kidney 5. patient unable to undergo renal mass protocol ct or mri 6. severe allergy to iodinated contrast not mitigated by steroid and diphenhydramine prophylaxis 7. uncorrectable coagulopathy, including a platelet count of \ 2.5 that does not respond to platelet transfusion or prothrombin complex concentrate infusion, respectively 8. performance status precludes enrollment as determined by the investigators
journey for control of diabetes study (0431-111)

Conditions: Type 2 Diabetes Mellitus

Summary: behavior change and self-efficacy are key for patients with diabetes to sustain blood sugar goals, but most care systems do not provide effective support to assist patients in successful ongoing self-management. after initial education, many programs are limited by allowable medicare reimbursement for diabetes education which currently requires physician referral and cannot exceed two hours of training per year for a beneficiary, plus one hour of nutritional services. these services are usually provided either on an individual basis or occasionally through a traditional group class approach. for patients with established type 2 diabetes who are not achieving optimal glycemic control, we propose to develop and formally evaluate in a randomized trial a novel group experience to educate and motivate patients with established type 2 called idea, (interactive dialogue to educate and activate). this multi-site, randomized, prospective trial will randomize 621 patients with inadequately blood sugar control levels to one of 3 study groups: (1) idea - patients receive group sessions totaling 8 hours, with an average of 10 patients per group, using conversation maps as a conduit to facilitate dialogue between providers and patients (2) individual education (ie) - patients receive 2 hours with a nurse educator and 1 hour with a dietitian, and (3) usual care (uc)- patients receive no research intervention. the primary analyses will involve mixed model regression to assess whether idea improves outcomes compared to ie and uc. blood sugar level, blood pressure, and lipids will be evaluated 6 and12 months post-randomization and behavioral, emotional, and satisfaction outcomes through survey at baseline, 3, 6, 9 and 12 months. depending on 12 month results, a longitudinal four year post intervention analysis is planned to assess sustainability of treatment effects and cost-effectiveness.


Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus exclusion criteria: * gestational diabetes * type 1 diabetes mellitus
maintaining a prone position after use of an epidural blood patch for the treatment of post-dural puncture headache

Conditions: Post-Dural Puncture Headache

Summary: the main objective of this study is to assess the rate of recurrence of headache following a first blood patch where patients will be positioned in the prone position for an hour after each blood patch needed during this study.

the secondary objectives of this study are to: a. to evaluate the number of blood patches needed for each patient during her hospital stay b. assessing the intensity of all headaches every 24h c. evaluate the complications occurring during the hospital stay.

Eligibility criteria:
inclusion criteria: * the patient was informed about the implementation of the study, its objectives, constraints and patient rights * the patient has signed the informed consent * the patient must be affiliated or beneficiary of a health insurance plan * the patient is available for follow up concerning her hospital stay * the patient has a post-dural puncture headache after a vaginal delivery. the diagnosis of post-puncture headache is retained on the basis of a frankly postural character for the headache, triggered or exacerbated by orthostatic position and relieved by recumbency. * the patient has an indication for a blood patch exclusion criteria: * the patient is participating in another interventional study, with the exception of the following studies: papillo pma (2013-a00538-37); dg-postpartum (2013-a00277-38); elastomap (2013-a01148-37); elastodéclench (2014-a00828-39); lxrs(2009-a00968-49); oasis ii (2013-a00773-42); grosspath (2014-a01120-47). * the patient is in an exclusion period determined by a previous study * the patient is under guardianship, curatorship or under judicial protection * the patient refuses to sign the consent * it is not possible correctly inform the patient * the patient is pregnant * the patient has a contra-indication (or an incompatible combination therapy) for a necessary treatment in this study * the patient was delivered by cesarean section
impact of a low-carbohydrate diet in pediatric type 1 diabetes

Conditions: Type 1 Diabetes

Summary: dietary carbohydrate consumption is a key factor influencing postprandial glycemia for patients with type 1 diabetes mellitus (t1dm). because post-prandial glucose excursions profoundly influence hemoglobin a1c (hba1c), therapeutic approaches to mitigate post-prandial hyperglycemia are of great importance. the quantity and source of carbohydrates affect post-prandial glycemia more than any other dietary factor. these findings serve as the physiologic basis for a growing interest in carbohydrate-restricted diets in the management of t1dm despite american diabetes association (ada) guidelines that discourage restricting total carbohydrate intake to less than 130 grams per day. although case series and prospective studies suggest low-carbohydrate diets (lcd) significantly improve hba1c for adults with t1dm, data in the pediatric t1dm population is limited. the investigators will conduct a randomized prospective pilot study evaluating glycemic control, lipidemia, and quality of life (qol) in pediatric t1dm patients on a lcd.


Eligibility criteria:
inclusion criteria: * diagnosed with t1dm for at least 12 months * age 13 to 21 years * total daily dose of insulin 0.5 to 1.25 units/kg/day * current use of an insulin pump and cgm * hba1c between 7% and 10% * tanner stage 3 to 5 on physical exam * participant or parent of participant use of smart phone * able to read and speak english exclusion criteria: * any episode of diabetic ketoacidosis (dka) in the last 12 months * any episode of severe hypoglycemia (defined as requiring assistance from another person, including coma, seizures, or episodes requiring glucagon, iv dextrose or oral carbohydrate administered by another person) in the last 12 months * any prior abnormal fasting lipid panel (ldl \> 130) * additional dietary restrictions * following a weight-loss or otherwise restrictive diet * use of medication or supplements other than insulin to control blood glucose * use of medication or other supplements to lower lipids * pregnancy or breast feeding * history of hemoglobinopathy

Keywords: low carbohydrate diet standard carbohydrate diet
a study of sunitinib in combination with capecitabine compared with capecitabine in patients with breast cancer

Conditions: Breast Neoplasms

Summary: the treatment received with sunitinib plus capecitabine could delay tumor growth longer than with treatment with capecitabine alone.


Eligibility criteria:
inclusion criteria: * locally advanced or metastatic disease that can be measured. patients with bone-only disease are also allowed to enter the study. * previous treatment with an anthracycline and a taxane in any setting * progression on first or second line regimen or adjuvant regimen if disease free interval less than 12 months exclusion criteria: * history of inflammatory carcinoma if there is no other measurable disease * more than 2 chemotherapy agents in the advanced disease setting * brain metastases
efficacy of erector spinae plane block analgesia after off pump cardiac surgery

Conditions: Postoperative Pain

Summary: in this study the investigators will investigate the efficacy of espb as a part of enhanced recovery after surgery on postoperative analgesia and recovery criteria after off pump cardiac surgery.

general anaesthesia will be induced by 0.05 mg/kg midazolam, 3 µg/kg fentanyl, 1-2mg/kg propofol, and 0.5mg/kg of atracurium. after induction, bilateral erector spinae plane block will be performed in the block group. intraoperative analgesia will be achieved by fentanyl boluses of 0.5-to-1 µg/kg titrated according to haemodynamic parameters. postoperative analgesia will be managed by paracetamol 1000 mg /6hours and morphine 1-2mg boluses when pain score ≥4 1 to 2 mg to be repeated every 5 minutes if needed.

Eligibility criteria:
inclusion criteria: * age 18-70 years * ejection fraction of \> 45% * undergoing elective off-pump cardiopulmonary bypass surgery exclusion criteria: * vertebral anomalies * intra-aortic balloon pump in the preoperative period * acute myocardial infarction * local infection at the site of block * allergy to the local anesthetic used * morbid obesity, psychiatric disorders, neurologic deficits, alcohol and chronic opioid abuse, and patients with bleeding diathesis.
a study of topical ns2 cream to treat ichthyosis in sjögren-larsson syndrome (sls)

Conditions: Sjögren-Larsson Syndrome

Summary: this is a multi-center, randomized, double-blind, vehicle-controlled, parallel-group study designed to evaluate the safety, pharmacokinetic (pk), and exploratory activity of topically-applied ns2 dermatologic cream administered once-daily (qd) to subjects with ichthyosis secondary to sjögren- larsson syndrome (sls). ns2 is expected to trap fatty aldehydes that are pathogenic in sls patients, and thereby diminish the lipid-aldehyde adduct formation that likely results in ichthyosis associated with sls, and potentially reduce the mild dermal inflammation characteristic of sls.


Eligibility criteria:
inclusion criteria: * genetically-confirmed diagnosis of sls * active ichthyosis on the lower extremities that is determined to be at least moderate severity exclusion criteria: * evidence of an active infection * currently receiving immunosuppressive therapy, including intermittent or low-dose corticosteroids and is not able or willing to suspend from 2 weeks before and during the study * currently receiving systemic or topical retinoids, other topically applied drugs, or other supplements that could interfere with dermatologic examination findings * received an investigational systemic or topically administered drug within 30 days before screening

Keywords: sjögren-larsson syndrome sls faldh deficiency neuro-ichthyosis fatty alcohol:nad+ oxidoreductase deficiency fatty aldehyde dehydrogenase deficiency disease congenital icthyosis mental retardation spasticity syndrome spastic neurologic disorder oligophrenia ichthyosis
clinical evaluation of the nucleus 5 cochlear implant (ci) system

Conditions: Hearing Loss

Summary: to evaluate the performance of the nucleus 5 cochlear implant system.

performance outcomes of newly implanted adult recipients using the nucleus 5 cochlear implant system.

Eligibility criteria:
inclusion criteria: * eighteen years of age or older at the time of the study. * postlinguistic onset of bilateral severe-to-profound sensorineural hearing loss * bilateral severe-to-profound hearing loss that meets current cochlear implant criteria (\<50% open-set sentence recognition in quiet scores in the ear to be implanted and \<60% in the best-aided condition) * english spoken as the primary language. * willingness to participate in and to comply with all requirements of the study * subject may receive bilateral simultaneous cochlear implants. exclusion criteria: * previous cochlear implant experience * congenital hearing loss (for the purpose of this study, onset prior to 2 years-of-age). * ossification, absence of cochlear development or any other cochlear anomaly that might prevent complete insertion of the electrode array. * normal hearing in one or both ears. * hearing loss of neural or central origin (e.g., deafness due to lesions on the acoustic nerve or central auditory pathway). * active middle-ear infection. * unwillingness and/or inability of the candidate to comply with all investigational requirements including, but not limited to, study protocol and surgical procedure.

Keywords: speech perception ability in the ci alone condition
an exposure-based implementation strategy to decrease clinician anxiety around suicide prevention

Conditions: Implementation Science

Summary: study objectives are to design and pilot test a novel, exposure-based implementation strategy (ebis) directly targeting clinician anxiety and low self-efficacy for use of evidence-based suicide screening, assessment, and intervention (ssai) strategies with patients at risk for suicide in community settings. early phases of this study will develop the ebis in partnership with community clinicians (n = 15). the last phase of this study is a pilot clinical trial in which 40 community mental health clinicians will be randomized to receive either implementation as usual (iau) or iau+ebis.

this exploratory project brings together an interdisciplinary team to design and pilot-test an exposure-based implementation strategy (ebis) to target clinician-level anxiety about suicide screening, assessment, and intervention (ssai) use. we will test the effect of ebis as an implementation strategy to augment implementation as usual (iau) to enhance ssai implementation in community mental health settings. specifically, this study first will use participatory design methods to develop and refine ebis in collaboration with a stakeholder advisory board of clinicians, administrators, and content experts. this study then will further iteratively refine ebis with up to 15 clinicians in a pilot field test, using rapid cycle prototyping, in collaboration with the inspire methods core. clinicians in aim 2 will also provide qualitative feedback on ebis' ability to mitigate anxiety and increase self-efficacy to deliver ssais to optimize our ability to engage target mechanisms of clinician anxiety. in the final phase, this study will test the refined ebis in a pilot implementation trial in which 40 community mental health clinicians will be randomized to receive either iau or ebis+iau. primary clinical trial dependent variables are ebis acceptability and feasibility, measured through questionnaires, interviews, and recruitment and retention statistics; this pilot trial is not intended to be powered to detect effects. secondary outcomes are preliminary effectiveness of ebis on clinician-level implementation outcomes (ssai adoption), and engagement of target implementation mechanisms (clinician anxiety and self-efficacy related to ssai use), assessed via mixed methods.

Eligibility criteria:
inclusion criteria: * practicing mental health clinicians who provide direct mental health services to a treatment-seeking population * proficient in the english language * have access to a computer with internet connectivity exclusion criteria: * participants will be excluded if they do not see any mental health patients that are at risk for suicide (e.g., they screen out high-risk patients for their individual practice).
treatment phenotypes for adolescents with asthma

Conditions: Asthma in Children; Adherence, Treatment

Summary: this study will evaluate how adolescents take their asthma medications using an electronic medication monitor.

this study will look at how adolescents use both their controller and rescue medications using an electronic medication monitoring platform, for the period of one year. participants will be enrolled in a medication monitoring platform, and their asthma care provider will have access to medication usage information. the study team will collect data on medication use patterns in a real world setting for 12 months per participant. additionally, healthcare providers will be enrolled in focus groups to determine barriers and facilitators to optimal medication use for their patients.

Eligibility criteria:
for adolescent participants: inclusion criteria: * diagnosis of asthma on an inhaled controller and rescue medication for which a propeller health device is available exclusion criteria: * other significant chronic lung disease (from problem list) * cystic fibrosis * chronic respiratory failure * tracheostomy status * intersititial lung disease * significant developmental delay * taking more than 3 asthma related medications * primary language other than english, spanish, catalan, dutch, french, german or italian healthcare providers will be recruited as well to participate in focus groups as part of specific aim 2.
vegetative monitoring during brainstem-associated surgery

Conditions: Brain Tumor, Recurrent; Vestibular Schwannoma; Brainstem Neoplasm; Brainstem Glioma

Summary: intraoperative monitoring of heart rate variability, blood pressure variability, baroreceptorsensivity etc.


Eligibility criteria:
inclusion criteria: * age 0-99 * brain tumor exclusion criteria: * no consent
randomized placebo controlled efficacy and safety study investigating gw876008 in patients with irritable bowel syndrome

Conditions: Irritable Bowel Syndrome (IBS)

Summary: this is a double-blind, placebo-controlled, randomised crossover study to investigate the efficacy and safety of gw876008


Eligibility criteria:
inclusion criteria: * the subject has been diagnosed with ibs consistent with the rome ii criteria as adapted in appendix 3 of the protocol * the subject has normal results from a flexible sigmoidoscopy, colonoscopy, or a flexible sigmoidoscopy plus barium enema, according to subject's age, within 5 years of randomization. otherwise, the appropriate procedure(s) must be performed and normal results obtained during the 7-day procedure window (prior to randomization): if the subject is \< 50 years of age and has not had a colonic examination within 5 years of the screening visit, flexible sigmoidoscopy, or colonoscopy must be performed. if the subject is = 50 years of age and has not had a colonic examination within 5 years of the screening visit, a colonoscopy or flexible sigmoidoscopy plus barium enema must be performed. * colonic procedure results must be known prior to randomization into the study and dispensing study medication * during the two-week screening phase, the subject must have conducted self assessments on = 10 days of 14 day (with 80% compliance on daily ivrs calls) compliance assessment using the telephone data entry system exclusion criteria: * as a result of any of the medical interview, physical examination, evaluation of mental state and psychiatric history or screening investigations the physician * subject reported no stool for 7 consecutive days during the two-week screening phase responsible considers the subject unfit for the study * the subject has a concurrent illness or disability that may affect the interpretation of clinical data, or otherwise contraindicates participation in this clinical study (e.g., an unstable cardiovascular, autoimmune, renal, hepatic, pulmonary, endocrine, metabolic, gastrointestinal, haematological, or neurological condition).

Keywords: irritable bowel syndrome safety
a phase 2 study to evaluate effects of vx-661/ivacaftor on lung and extrapulmonary systems in subjects with cystic fibrosis, homozygous for the f508del-cftr mutation

Conditions: Cystic Fibrosis

Summary: to evaluate the clinical mechanisms of action in lung and extrapulmonary systems of vx-661 (tezacaftor; tez) in combination with ivacaftor (iva) (tez/iva) in participants with cystic fibrosis (cf) who are homozygous for the f508del mutation on the cf transmembrane conductance regulator (cftr) gene.


Eligibility criteria:
inclusion criteria: * male and female participants, homozygous for the f508del cftr mutation * confirmed diagnosis of cf by sweat chloride testing * forced expiratory volume in 1 second (fev1) ≥40% and ≤90% of predicted normal for age, sex, and height at screening visit * stable cf disease as judged by the investigator. exclusion criteria: * history of any comorbidity that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the subject. * an acute upper or lower respiratory infection, pulmonary exacerbation, or changes in therapy for pulmonary disease within 28 days before day 1 * history or evidence of clinically significant findings on ophthalmologic examination during the screening period. * history of solid organ or hematological transplantation * pregnant or nursing females * participants who have had radiation exposure within 1 year before the first mucociliary clearance (mcc) procedure that would cause them to exceed federal regulations by participating in this study * in the opinion of the investigator, unable to adequately perform inhalation maneuvers during the mcc procedures
defining a dosing regimen with maximal absorption for oral iron supplementation during pregnancy

Conditions: Iron Deficiency Anemia of Pregnancy

Summary: iron deficiency anemia (ida) is common during pregnancy and has adverse effects on the mother, fetus and newborn. oral iron supplements are usually recommended to prevent id/ida during pregnancy. the aim of this study is to define an iron supplementation schedule with maximal absorption using serum hepcidin profiles and stable iron isotopes in pregnant women. in this randomized, open-label trial, fractional and total iron absorption will be compared from daily dosing with 60 mg iron versus alternate day and every third day dosing with 120 mg iron in pregnant thai women with low iron stores (n=28) during their second trimester of pregnancy. this study could have wide impact, providing the evidence base for revised, improved recommendations for iron supplementation during pregnancy.


Eligibility criteria:
inclusion criteria: * gestational week 14-16 at study start * singleton pregnancy * serum ferritin sf \<60 µg/l * non-anemic or mildly anemic, defined as hemoglobin (hb) \>10 g/dl * female aged 18-45 years * healthy thai woman exclusion criteria: * acute or chronic disease * taking medications that could influence iron absorption * smoking