Kornimate/medical-research-clean huggingface dataset:
comparison of speech therapy and audioprosthetic care in older adults with first-time hearing aids

Conditions: Hearing Loss

Summary: the purpose of the study is to evaluate the score of the evaluation of the impact of deafness in adults(ersa)/150 questionnaire obtained at 3 months compared to the inclusion score.

this is a pilot, prospective, interventional, comparative, randomized, longitudinal, open, multicenter study comparing synchronous and delayed hearing aid and speech therapy. patients will be randomly divided by drawing lots into 2 groups. both groups will benefit from a hearing aid prescription and speech therapy for a series of 24 sessions at the rate of 1 per week, for an approximate duration of 6 months. group a will benefit from speech therapy and synchronous equipment, and group b will begin speech therapy after 3 months after the installation of the equipment. regarding the equipment, it will not be the same for all patients. indeed, it is the one that will best suit the patient who will be chosen. the same will apply to the settings, in accordance with the usual support.

Eligibility criteria:
inclusion criteria: * patient, male or female, aged 65 to 80; * first equipment; * average hearing loss between 40 and 70 db; * speech comprehension greater than 50%; * absence of acoustic recruitment phenomenon; * symmetrical bilateral deafness (inter aural difference \<20db); * affiliated patient or beneficiary of a social security scheme; * patient speaking and understanding french, able to complete questionnaires and scales; * patient having been informed and having signed an informed consent to participate in the study. exclusion criteria: * patient with a psychiatric pathology; * patient with neurological disorders; * patient taking psychotropic drugs; * patient participating in another clinical study; * protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision; * patient hospitalized without consent.
therapeutic efficacy in women with stress urinary incontinence

Conditions: Women With Stress Urinary Incontinence

Summary: we will get the impact of duloxetine versus imipramine on therapeutic efficacy in women with sui.

background/purpose: pharmacologic treatments for female stress urinary incontinence (sui) include duloxetine and imipramine. duloxetine and imipramine has been reported to have clinical significant therapeutic efficacy on female sui and overactive bladder syndrome. however, there was no randomized controlled study to compare duloxetine and imipramine for the treatment of female sui. patients and methods: we will perform a prospective randomized controlled study to recruit 90 female sui patients at the obstetrics \& gynecology outpatient clinic of far eastern memorial hospital. all sui female patients will be asked to complete iciq-ui, uss, oabss, and bladder diary before and after 4 weeks' duloxetine versus imipramine treatment.

Eligibility criteria:
inclusion criteria: * female patients over 25 years old with stress urinary incontinence. * patients who are currently not considered for surgical treatment. * patients who have undergone regular kegel exercises but have poor results. exclusion criteria: * the result of urodynamic examination, if the main cause of urinary incontinence is detrusor overactivity. * those who are taking or plan to take monoamine oxidase inhibitor (maoi) inhibitors. * patients with acute myocardial infarction. * those who are allergic to duloxetine, imipramine and dibenzazepine tricyclic antidepressants. * patients with uncontrolled narrow-angle glaucoma. * pregnant women. * those who are contraindicated to duloxetine or imipramine. * patients with suicidal ideation and behavior.
fenobam on heat/capsaicin induced hyperalgesia in healthy volunteers

Conditions: Hyperalgesia; Allodynia

Summary: our goal is to demonstrate that healthy volunteers treated with fenobam will develop a significantly reduced area of cutaneous hyperalgesia compared to volunteers treated with placebo, after exposure to the heat/capsaicin model of cutaneous sensitization. additionally we are going to assess changes in mood/affect and cognitive function of subjects following administration of fenobam and after cutaneous sensitization compared to baseline.

all subjects will receive a topical dose of capsaicin cream 0.1%(capzasin-hp) to the forearm at the start of the study visit. the order of the 2 treatment regimens indicated below will be randomized and blinded to subjects and researchers. treatment regimen 1: fenobam \[1-(3-chlorophenyl)-3-(1-methyl-4-oxo-2-imidazolidinylidine) urea hydrate\]: administration of one 150 mg gelatin capsule. treatment regimen 2: placebo (lactose monohydrate): administration of one 150 mg gelatin capsule.

Eligibility criteria:
inclusion criteria: 1. 18-50 year old 2. good general health with no remarkable medical conditions (e.g. liver, kidney, heart, or lung failure) 3. bmi between 20-33 4. willing to comply with study guidelines as outlined in protocol \[including: women of childbearing age must be willing to use a double-barrier method (e.g. oral contraception and condom) for contraception during participation in the study\] 5. willing to provide informed consent exclusion criteria: 1. anatomical malformation of upper extremities 2. status post recent trauma or chronic lesions on either forearm 3. medication use (includes vitamin, herbal, dietary and mineral supplements and grapefruit products during or within 14 days prior to study participation; excludes contraceptives) 4. history of allergy or intolerance to capsaicin 5. history of multiple drug allergies 6. history of addiction to drugs or alcohol (prior or present addiction or treatment for addiction) 7. history of chronic pain syndromes 8. pregnant and nursing females 9. smokers

Keywords: fenobam heat capsaicin hyperalgesia allodynia mood cognitive function
registry of subjects at risk of pancreatic cancer

Conditions: Familial Pancreatic Cancer; BRCA1 Mutation; BRCA2 Mutation; Lynch Syndrome; FAMMM - Familial Atypical Mole Malignant Melanoma Syndrome; Hereditary Pancreatitis; Peutz-Jeghers Syndrome

Summary: irfarpc is a multicenter national registry designed to study the diagnosis and predisposing factors of subjects with an inherited increased risk for pancreatic cancer.

pancreatic cancer is a devastating disease with a dismal prognosis. one of the ways to improve survival might be early detection. within years, many predisposing diseases or genetic conditions have been identified, thus screening/surveillance have been established worldwide. a registry of subjects at risk of pancreatic cancer will has been built up to investigate the possibility of diagnosis pancreatic cancer, or one if its predisposing lesions. inclusion criteria will be adopted as "enrollment criteria". according to this, individuals \> 18 years old will be enrolled; their familiar history and/or genetic predisposition will be collected, as well as current or previous medical records/medications data. thereafter, according to specific age-based criteria, those individuals initially enrolled will be will be considered for a "surveillance protocol" ("interventional follow-up criteria") and they will be submitted to cholangio-wirsung magnetic resonance or pancreatic endoultrasonography according to the pancreatologist's prescription at each participating center. individuals suffering from the following conditions will be enrolled: familial pancreatic cancer; peutz-jeghers syndrome; a known brca-2, brca-1, palb2, or p16 mutation with at least one first- or second-degree relative suffering from pancreatic cancer; hereditary pancreatitis; fammm syndrome; lynch syndrome with at least one first- or second-degree relative suffering from pancreatic cancer.

Eligibility criteria:
inclusion criteria to enter the registry: * individuals with at least two relatives suffering from pancreatic cancer, with at least 1 first-degree and until the third-degree * subjects with known genetic mutation of brca2, brca1, p16, palb2 with at least 1 first- or 2nd-degree relative suffering from pancreatic cancer * subjects suffering from fammm syndrome * subjects suffering from peutz-jeghers syndrome * subjects suffering from prss-1- or cftr- or spink-1- related pancreatitis * subjects suffering from lynch syndrome with at least 1 first- or 2nd-degree relative suffering from pancreatic cancer inclusion criteria to join the "radiologic follow-up": * 45 years or 10 years younger than the youngest index case of pancreatic cancer in the family for familial cases * 40 years or 5 years younger than the youngest index case of pancreatic cancer for subjects suffering from hereditary/genetic pancreatitis, lynch syndrome, or carrying a known brca 1/2, palb2, p16 genetic mutation with familiarity for pancreatic cancer * 30 years for subjects suffering from fammm, peutz-jeghers syndrome exclusion criteria: - pregnancy

Keywords: familial pancreatic cancer brca mutation lynch syndrome screening pancreatic cancer surveillance pancreatic cancer
remote ischemic perconditioning in patients with st-segment elevation myocardial infarction

Conditions: ST-segment Elevation Myocardial Infarction

Summary: to evaluate whether remote ischemic per-conditioning (ripc) can reduce infarct size in patients with st-segment elevation myocardial infarction treated with primary percutaneous coronary intervention (ppci) within 12 hours of symptoms onset. * control group: ppci only * study group: ppci + ripc primary endpoint: infarct size measured by contrast-enhanced cardiac magnetic resonance (cmr) at 6 months after the index procedure

st-elevation myocardial infarction (stemi) is a leading cause of mortality and morbidity. early myocardial reperfusion with either of thrombolytic therapy or primary percutaneous coronary intervention (ppci) is the most effective strategy for reducing the size of a myocardial infarct and improving the clinical outcome. although this process can restore blood flow to the ischemic myocardium, it can induce injury. this phenomenon termed myocardial reperfusion injury can paradoxically reduce the beneficial effects of myocardial reperfusion. the pre-clinical study in animal models of acute myocardial infarction suggests that lethal reperfusion injury accounts for up to 50% of the final size of a myocardial infarct. remote ischemic conditioning uses brief ischemia and reperfusion of a distant organ to protect the myocardium. in animal study, remote ischemic postconditioning seems to be more effective than local postconditioning in experimental myocardial infarction.bøtker et al. has reported remote ischemic preconditioning before hospital admission increase myocardial salvage in patients with acute myocardial infarction. the objective of this study is to evaluate whether remote ischemic per-conditioning (ripc) can reduce late infarct size in patients with stemi treated with ppci within 12 hours of symptoms onset. to test this hypothesis, we will randomize patients into ppci + ripc or ppci alone. we will evaluate marker of reperfusion injury using contrast cardiac magnetic resonance image.

Eligibility criteria:
inclusion criteria: * age \>19 years * presenting within 12 hours of symptom onset * \>20 min of chest pain * st-elevation myocardial infarction defined as st-segment elevation (\>0.1 mv) in at least 2 contiguous precordial leads exclusion criteria: * previous myocardial infarction * presence of chronic total occlusion * evidence of retrograde filling by collaterals at coronary angiography (rentrop 2 or 3 collateral flow) * severe multi-vessel coronary artery disease to require further interventions before follow-up cmr * cardiac arrest before randomization * arrhythmias requiring external electric shock before randomization * unwillingness to participate * external electric shock for cardioversion within first 3 days * cardiac surgery within first 3 days

Keywords: st-segment elevation myocardial infarction remote ischemic perconditioning primary percutaneous coronary intervention cardiac magnetic resonance
fludarabine or chlorambucil as first-line therapy in treating older patients with previously untreated chronic lymphocytic leukemia

Conditions: Chronic Lymphocytic Leukemia

Summary: rationale: drugs used in chemotherapy, such as fludarabine and chlorambucil, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. it is not yet known whether fludarabine is more effective than chlorambucil in treating chronic lymphocytic leukemia. purpose: this randomized phase iii trial is studying fludarabine to see how well it works as first-line therapy compared to chlorambucil in treating older patients with previously untreated chronic lymphocytic leukemia.

objectives: primary * compare the overall and progression-free survival of older patients with previously untreated chronic lymphocytic leukemia treated with fludarabine vs chlorambucil. * compare the duration of remission in patients treated with these regimens. secondary * compare the incidence of toxicity, especially infections, in patients treated with these regimens. * compare the quality of life in patients treated with these regimens. outline: this is a randomized, multicenter study. patients are randomized to 1 of 2 treatment arms. * arm i: patients receive fludarabine iv on days 1-5. treatment repeats every 28 days for up to 6 courses. * arm ii: patients receive oral chlorambucil on day 1. treatment repeats every 15 days for up to 12 months. projected accrual: a total of 205 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * confirmed diagnosis of chronic lymphocytic leukemia, meeting any of the following staging criteria: * binet stage a with b symptoms * binet stage b or c, meeting 1 of the following criteria: * rapid disease progression * enlarged lymph nodes and organs * severe b symptoms * previously untreated disease patient characteristics: performance status * ecog 0-2 life expectancy * more than 6 months hematopoietic * no thrombocytopenia * no autoimmune hemolytic anemia hepatic * not specified renal * not specified other * no severe organ dysfunction * no other prior or concurrent neoplasm prior concurrent therapy: chemotherapy * no prior chemotherapy * no other concurrent chemotherapy

Keywords: stage 0 chronic lymphocytic leukemia stage i chronic lymphocytic leukemia stage ii chronic lymphocytic leukemia stage iii chronic lymphocytic leukemia stage iv chronic lymphocytic leukemia
topical keratin in treating radiation dermatitis in patients with breast cancer

Conditions: Breast Carcinoma; Radiation-Induced Dermatitis

Summary: this randomized pilot clinical trial studies how well topical keratin works in treating radiation dermatitis in patients with breast cancer. radiation dermatitis is a skin condition that is a common side effect of radiation therapy. the affected skin becomes painful, red, itchy, and blistered. topical keratin may help to improve skin appearance and hydration in patients with breast cancer.

primary objectives: i. to determine a preliminary estimate of the improvement of skin's natural barrier, decrease of dehydration, and reduction in the appearance of inflammation associated with radiation therapy (rt) skin toxicity as well as patients' satisfaction with their skin after the application of the medical device topical keratin (kerastat cream) during rt in breast cancer patients. outline: patients are randomized to 1 of 2 groups. group i: patients receive topical keratin topically at least twice daily (bid) until the end of radiation therapy (approximately 3-6 weeks). group ii: patients receive standard of care as directed by radiation oncologist until the end of radiation therapy (approximately 3-6 weeks). after completion of study treatment, patients are followed up at 4-6 weeks.

Eligibility criteria:
inclusion criteria: * diagnosis of breast cancer, received chemotherapy, and scheduled to receive 4 to 6 weeks of radiation therapy (radiation protocol of 42 gy+) * area to be irradiated representing 1-10% of total body surface area (tbsa) * able and willing to sign protocol consent form * able and willing to document symptoms and treatment details as often as needed, not to exceed daily notes * able and willing to have photographs of the affected area taken regularly exclusion criteria: * women who are pregnant, lactating/nursing or plan to become pregnant * previous radiation therapy to the area to be treated with radiation therapy * receiving palliative radiation therapy * unhealed or infected surgical sites in the irradiation area * patients undergoing cytotoxic chemotherapy or concurrent herceptin as part of overall treatment plan (tamoxifen/aromatase inhibitor allowed) * use of oral corticosteroids or topical corticosteroids in the irradiation area * use of erbitux * autoimmune disease * skin disease in target irradiation area * smoker * known allergy to the standard of care or ingredients in kerastat cream
better understanding slow language impairment

Conditions: Slow Language Impairment

Summary: this study was designed to examine the development of children aged 6 to 10 with slow language impairment (sli). the aim was threefold: (1) to investigate language skills of children with sli at different levels - formal, semantic, pragmatic- in comparison with those of control children; (2) to test a procedural deficit hypothesis: abnormal development in the procedural memory system could account for some language deficits; (3) to make genotype-phenotype comparisons, focusing on the different levels of language development and on procedural skills. the main hypothesis is that genetic mutations, contingently epistatique, will lead to procedural learning deficit, which will have a negative impact on language skills at the formal level and consequently on semantic and pragmatic levels.

to test the main hypothesis, 60 sli children and 100 controls children will be included on the protocol. due to the lack of specific standardized tests, the diagnostic of specific language-impaired french children is a challenge. thus, both a battery of standardized and non-standardized language tests (assessing the different levels: formal, semantic and pragmatic) will be administered to children to establish a profile of weaknesses for each child with sli and to examine the relationships between sli and procedural learning. dna sampling will be conducted on each child, sli and control, to allow subsequently the molecular analyses in order to run the association comparisons between behavioral data and genetic profiles. the protocol includes as verbal standardized tests: the echelle "vocabulaire en images peabody" (evip;), the "epreuve de compre´hension syntaxico-semantique" (ecosse), two specific subtests (lexicon and grammar) of the "evaluation du langage oral" (elo;), and as non-standardized tests: a semantic inference task (drawing the meaning of new words from the context, and the meaning of predicative metaphors), and a pragmatic inference task (understanding of indirect requests, on speakers' intention meaning and on irony). the procedural learning skills will be assessed thanks to a serial reaction task, specifically adapted for children). the complete sequencing of foxp2 gene, as well as the genotyping of the 44 single nucleotide polymorphisms (snps), located in the risk haplotypes identified in atp2c2, cmip, cntnap2 genes and in the kiaa0319/ttrap/them2 locus, will be conducted.

Eligibility criteria:
inclusion criteria: for sli group, the inclusion criteria are: * to present a slow language impairment * to speak french for control group, the inclusion criteria are: * being at elementary french school * speak french exclusion criteria: * child with a neuro-motrice pathology or psychopathology * child with a neurological medication * child who have a score inferior to percentile 20 on the "coloured progressive matrices" (raven, 1998)

Keywords: slow language impairment semantic pragmatic procedural learning genotype
dose-response effect exercise and depression

Conditions: Depression

Summary: the present study aims to address gaps in the literature by evaluating the objectively measured dose-response relationship between exercise and depression symptoms; examining changes in resting (brain-derived neurotrophic factor) bdnf from baseline to week 10 of an exercise intervention; and assessing varying exercise intensities on enjoyment, affect, and health-related quality of life in sedentary young adult college students.

this 10-week randomized single-blind controlled trial will consist of an exercise intervention and attention control condition. a two-week familiarity trial period will be followed by 8 weeks of structured exercise. objectively measured physical activity will be remotely monitored via fitbit to examine its effect on depressive symptoms in sedentary young adult college students. approximately 48 enrolled college students ages 18 - 25 will be recruited for the proposed study and randomized with a 1:1:1 allocation to one of the following conditions: 1. high-dose (hd) moderate to vigorous physical activity (mvpa) (n=16) 2. moderate-dose (md moderate to vigorous physical activity (mvpa) (n=16) 3. a walking (w) attention control (n=16)

Eligibility criteria:
inclusion criteria: * enrolled ucf college students aged 18 to 25 * mild to moderate depressive symptoms * willing to wear a fitbit for extended periods of time during the study * willing to participate in moderate-to-vigorous pa * physically able to participate in exercise safely exclusion criteria: * under 110 lbs * history of bad reaction to a past blood draw * have been advised by a medical provider to not give/donate blood * presence of anemia * current cognitive therapy or antidepressant medication * diagnosis of a co-occurring condition such as attention deficit hyperactivity disorder (adhd) * diagnosis of a serious mental illness (smi) such as schizophrenia or bipolar disorder * pregnant or nursing * current smoker * beta-blocker medications

Keywords: depression exercise bdnf brain-derived neurotrophic factor major depressive disorder mdd