Kornimate/medical-research-clean huggingface dataset:
internet delivered cbt for olfactory reference syndrome

Conditions: Olfactory Reference Syndrome

Summary: the primary aim of the study is to test the feasibility and efficacy of, a manual based, internet-delivered, cognitive behaviour therapy (cbt) for patients with olfactory reference syndrome (ors) who live in sweden. the secondary aim is to investigate smell sensitivity and body odor in these ors-patients.


Eligibility criteria:
inclusion criteria: * primary diagnosis of ors * outpatients * male or female * signed informed consent * have regular access to a computer with internet access and skills to use the web exclusion criteria: * not able to read or understand the basics of the icbt self-help material * psychotropic medication changes within two months prior to treatment * completed cbt for ors within last 12 months * ongoing substance dependence or misuse * lifetime bipolar disorder or psychosis * suicidal ideation * axis ii diagnosis that could jeopardize treatment participation * serious physical illness that will be an obstacle in icbt * other ongoing psychological treatments that could affect ors symptoms * epilepsia
noninvasive transcutaneous glucometer development

Conditions: Healthy; Prediabetic State (IGT); Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1

Summary: the objective of this study is to assist in the development of a noninvasive device for the accurate measurement of blood glucose levels.

the feasibility of measuring blood glucose concentration in patients with diabetes mellitus using near infrared (nir) spectroscopy and multivariate data analysis techniques has been established using general purpose, scientific-grade infrared spectrophotometers under the 90-049 unm hrrc protocol. now that the concept of painless, bloodless, and reagent-less clinical laboratory tests has been shown to be viable, the challenge is to bring this technology to the patients who need it. we must develop a device that is portable, affordable, and rugged - all while improving accuracy. we must also improve our understanding of the nature of glucose in whole, intact skin. since the light beam cannot discriminate plasma glucose in skin blood vessels from glucose in the larger skin interstitial fluid space, the exact nature of the glucose in all tissue compartments contributing to the light-beam signal must be elucidated. the noninvasive measurement can be no more accurate than the reference measurement on which it was based. finally, we have found that the accuracy of the noninvasive measurement also worsens as a function of time from the initial measurement. this effect is independent of instrumentation drift and is due to physical changes in the patient's skin such as variation of hydration, collagen, vascularity, glycation end-products, etc. to account for these sources of physiologic interference they must be evaluated independently and then compared to errors of the noninvasive predictions over time.

Eligibility criteria:
inclusion criteria: * 18 years of age or older * healthy * type i diabetics * type ii diabetics * impaired glucose tolerance exclusion criteria: * minor status (\<18 years of age) * pregnant
interprofessional community-based diabetes intervention for older adults

Conditions: Diabetes Mellitus, Type 2

Summary: this study will examine the feasibility and acceptability of a 6-month interprofessional community-based health promotion program, and explore its effects on older adults' self-management of type 2 diabetes (t2dm). recently enrolled clients of diabetes care guelph (dcg), who are age 65+ and have at least two other chronic conditions, will be eligible to participate. participants must be english speaking, community-dwelling, independent in activities of daily living, and mentally competent to give informed consent. the 6-month intervention will consist of: in-home visits by a registered nurse and registered dietitian from dcg; participation in a monthly diabetes wellness day group program offered through the guelph wellington seniors association (gwsa) together with dcg; peer support from trained volunteers at the diabetes wellness day group program; care coordination by the dcg registered nurse to help participants access necessary supports and services; and monthly team conferences between care providers at dcg and the gwsa to develop a client-centred plan of care. to evaluate the program, participants will complete interviewer-administered questionnaires before and after the intervention, and care providers and peer volunteers will take part in group interviews.


Eligibility criteria:
inclusion criteria: * age 65+ * referred to diabetes care guelph within the past 12 months * at least two chronic conditions in addition to type 2 diabetes mellitus * english speaking * community-dwelling, in the city of guelph * independent in activities of daily living * mentally competent to provide informed consent

Keywords: diabetes mellitus, type 2 comorbidity aged health services
expanded access use of stiripentol in dravet syndrome or sodium channel mutation epileptic encephalopathies

Conditions: Dravet Syndrome; Epileptic Encephalopathies Associated With SCN1A Mutations

Summary: this is an expanded access use of stiripentol in dravet syndrome or epileptic encephalopathies associated with sodium channel mutations who have failed other drugs in an effort to give them the best chance at seizure control and quality of life. as a treatment protocol and not a research study, children will only be monitored on a clinical basis for seizure improvement and side effects predominantly by parent and caregiver report.

the initial dose of stiripentol will be determined by the prescribing neurologist and titrated up to an initial goal dose of 50 mg/kg/day divided into 2 to 3 doses per day. further dose increases by 10-20 mg/kg/day increments up to a max of 100 mg/kg/day or 4000 mg total daily dose may be necessary for improved seizure control. stiripentol is available as gelatin capsules and powder sachets (250 mg, 500 mg). the same granule formulation (i.e. active, pvp and portion of sodium starch glycolate) used for the capsule is used in the final powder blend with a few additional excipients. depending upon patient weight, the 250 mg or 500 mg formulation will be utilized for each participant. caretakers will be queried about common adverse effects including drowsiness, tremor, ataxis, nausea, anorexia, weight loss, and emesis. intolerable adverse effects will prompt dose reduction or withholding medication. monitoring of these and other potential aes will occur during study visits and participant-initiated telephone calls throughout the study. safety events and tolerability will be recorded as adverse events (ae) or serious adverse events (sae). physical examination, weight, vital signs, and laboratory tests (cbc, complete metabolic panel, and aed levels) will be conducted at baseline and at least every 6 months and as clinically warranted.

Eligibility criteria:
inclusion criteria: * 6 months and older * diagnosis of dravet syndrome or epileptic encephalopathies associated with scn1a mutations defined as: * a documented gene mutation reported to result in dravet syndrome phenotype; or * clinical confirmation of dravet syndrome by two pediatric neurologists; or * clinical confirmation of other epileptic encephalopathies associated with sodium channel mutations * failure of at least 2 therapeutic anticonvulsants (excluding na channel blockers) indicative of intractable seizures exclusion criteria: * hypersensitivity to the active substance or to any of the excipients * past history of psychoses in the form of episodes of delirium * impaired hepatic and/or renal function, defined as creatinine \>2 and/or transaminase \>4xuln

Keywords: stiripentol dravet syndrome epilepsy epileptic encephalopathies
prospective evaluation of the predictive criteria of severity for respiratory infection due to covid-19 virus

Conditions: SARS-CoV2

Summary: emergency call centers are very solicited in epidemic situations. it is necessary to detect early predictive criteria of severity in covid respiratory infection to identify patients at risk of complication or aggravation from an emergency call center in order to adapt their orientation and their medical management.


Eligibility criteria:
inclusion criteria: * patient (more than 15 years old) calling the emergency call center (15 center) for low or high respiratory infection with or without fever and suspected to be covid exclusion criteria: * unknown contact facility * call not regulated by a practitioner from the medical emergency help team
outcome of covid-19 cases based on tuberculin test: can previous bcg alter the prognosis?

Conditions: COVID-19; BCG Vaccination

Summary: there is no evidence that the bacille calmette-guérin vaccine (bcg) protects people against infection with covid-19 virus. two clinical trials addressing this question are underway, and who will evaluate the evidence when it is available. in the absence of evidence, who does not recommend bcg vaccination for the prevention of covid-19. who continues to recommend neonatal bcg vaccination in countries or settings with a high incidence of tuberculosis. there is experimental evidence from both animal and human studies that the bcg vaccine has non-specific effects on the immune system. these effects have not been well characterized and their clinical relevance is unknown


Eligibility criteria:
inclusion criteria: * covid-19 positive cases admitted to hospitals in upper egypt exclusion criteria: * none

Keywords: outcome covid-19 pneumonia bcg tuberculin test positive egypt
flaxseed oil and pomegranate extract on inflammation, lipid profile and nutritional status of hemodialysis patients

Conditions: Chronic Kidney Diseases; Dialysis; Complications; Inflammation; Lipid Metabolism Disorders

Summary: nutritional and metabolic alterations in patients with chronic kidney disease (ckd) such as inflammation, oxidative stress, dyslipidemia, and poor nutritional status which associate with poor clinical outcome can potentially be targeted and ameliorated by interventions using nutritional supplements. the investigators evaluated the effects of 8 weeks of oral supplementation with flaxseed oil and pomegranate dry extract on markers of inflammation, lipid profile and nutritional status of individuals undergoing hemodialysis (hd). the goal of this randomized, placebo-controlled, double-blind clinical trial is to evaluate the effects of 8 weeks of oral supplementation with flaxseed oil and pomegranate dry extract on markers of inflammation, lipid profile and nutritional status of individuals undergoing hemodialysis (hd). participants will be randomly assigned, in a 1:1 ratio, to supplementation group to receive twice a day 1 capsule of 1.000 mg of flaxseed oil plus 1 capsule of 600mg of pomegranate dry extract; or to placebo group, to receive twice a day 1 capsule of 1.000 mg of sunflower oil plus 1 capsule of 600mg of microcrystalline celulose.


Eligibility criteria:
inclusion criteria: * age ≥ 19 years; have a diagnosis of ckd; * perform hd three times a week for a period of ≥ three months; * acceptance of participation. exclusion criteria: * history of allergy to flaxseed or pomegranate; * infection or hospitalization in the beginning or during the course of the study; * hiv seropositivity and active malignancy; * pregnancy or breastfeeding.

Keywords: chronic kidney disease hemodialysis inflammation dyslipidemia flaxseed pomagranate
psa glycomics assay for early detection of prostate cancer

Conditions: Prostate Cancer; PSA

Summary: the principal aim of this pilot study is to test whether the psa glycomics assay on urine and serum samples can provide insights regarding the disease state of patients with elevated psa concentrations, as well as to accurately identify if the patient has prostate cancer and, in the case of prostate cancer, to determine its level of aggressiveness.


Eligibility criteria:
inclusion criteria: * patients with elevated psa (\>3 ng/ml) * signed informed consent exclusion criteria: * patients that have a cystitis (bladder infection) * patients under chemotherapy * patients using 5-alpha reductase inhibitors * history or presence of cancers, or non-prostate urological disorders.

Keywords: prostate cancer psa glycomics assay
magnetomotoric ultrasound for diagnostic purposes in rectal cancer

Conditions: Rectal Cancer

Summary: a magnetomotive ultrasound combines standard diagnostic ultrasound equipment with the application of an external time-varying magnetic field. the investigators aim to use this equipment to improve preoperative diagnostics in rectal cancer.

the investigators will compare magnetomotive ultrasound with mri and pathology report on specimens extracted during surgery.

Eligibility criteria:
inclusion criteria: * rectal cancer * surgery with abdominoperineal resection exclusion criteria: * no informed consent * not fulfilling inclusion criteria * no rectal cancer
interactive virtual assistance for self-care management and mental health promotion in type 2 diabetes

Conditions: Diabetes Mellitus, Type 2; Depression, Anxiety; Mental Health Disorder; Old Age; Debility

Summary: backgroud: health technology is an important tool in the aging process, which may improve the health condition and self-esteem of the elderly, in addition to offering new opportunities and challenges. in this scenario, the use of virtual interaction systems emerge as promising alternatives for the old adults, which often deals with the lack of social interaction, cognitive decline and decline in functional capacity, making the control of chronic diseases, such as diabetes, a challenge. objectives: this project aims to evaluate the effectiveness of using an interactive virtual assistance system in mental health parameters, glycemic profile and diabetes selfcare behavior in elderly people with diabetes. methods: a randomized clinical trial is proposed, for an intervention that includes 3 months of use of the smart speaker echo dot system, programmed to provide reminders, stimulate treatment records and maintain healthy habits. outcomes assessed will include parameters of mental health and diabetes control.


Eligibility criteria:
inclusion: * being 65 years of age or older; * having a diagnosis of type 2 diabetes; * residing in porto alegre or metropolitan region; * presenting availability of wi-fi connection at home; and * presenting availability to participate in the proposed face-to-face evaluation and accept receiving one visit for installation of the device. exclusion: * having an interactive virtual home assistance device at the time of enrollment; * having cognitive impairments or severe hearing impairments that prevent adequate interaction with outcome assessors and the application of follow-up questionnaires; or * residing in regions of difficult access. recruitment: study subjects will be recruited through two different strategies: * screening of records of the outpatients clinics of hospital são lucas (hsl) * social media advertising, specially in instagram®
early aggressive strategy for treatment of lipid-lowering in acute ischemic stroke delivered with endovascular therapy for large artery occlusion

Conditions: Stroke

Summary: a prospective, multicenter, open-label, randomized controlled study to assess the effects of early intensive lipid-lowering initiated before endovascular treatment setting on (i) functional outcome in patients with acute ischemic stroke between preoperative intensive lipid-lowering therapy with pcsk9 inhibitor (pcsk9i) and guideline-recommended standard of care (soc)(ii) safety in these patients.

as a prospective, multicenter, open-label, randomized controlled clinical study, east-ldl will enroll 652 patients with acute ischemic stroke with anterior circulation large vessel occlusion undergoing endovascular treatment from approximately 10 clinical sites in china. this study aims to evaluate the effects of functional outcome according to an ordinal analysis of the full range of scores on the mrs, safety of lipid-lowering therapy, ldl-c goal attainment rate, change in inflammatory markers, incidence of recurrent ischemic stroke events , incidence of symptomatic intracranial hemorrhage transformation within 48 hours, incidence of new-onset hemorrhagic stroke, and incidence of maces in patients between early intensive lipid-lowering therapy with pcsk9 inhibitor and guideline-recommended standard of care treatment.

Eligibility criteria:
inclusion criteria: * adults (age 18 years and older); * imaging diagnosis of acute ischemic stroke with anterior circulation large vessel occlusion (including: internal carotid artery, middle cerebral artery m1 and m2, anterior cerebral artery a1 and a2); * planned to undergo endovascular intervention within 24 hours of symptom onset (or last known well time) according to local guidelines; * provision of informed consent by the patient or his/her legally authorized representative (or by an appropriate agent according to local requirements). exclusion criteria: * aspects score ≤5 on cranial ct imaging; * pre-existing functional impairment, with mrs score \>2; * patients who are allergic to pcsk9 inhibitors; * patients who have received pcsk9 monoclonal antibody within 1 month prior to enrollment or pcsk9 sirna therapy within 6 months prior to enrollment; * severe renal insufficiency, defined as estimated glomerular filtration rate (egfr) \< 15 ml/min/1.73m2 at final screening; * active liver disease or hepatic dysfunction, defined as aspartate aminotransferase (ast) or alanine aminotransferase (alt) \> 3 times the upper limit of normal; * severe, concomitant non-cardiovascular disease expected to reduce life expectancy to less than 3 months; * pregnant or lactating women; * patients who are participating in other clinical trials; * other conditions deemed unsuitable for inclusion in the clinical study by the investigator.

Keywords: acute ischemic stroke ldl-cholersterol lowering endovascular therapy pcsk9 clinical trials
kinetics of c-reactive protein during the management of acute coronary syndrome treated by transluminal angioplasty

Conditions: Acute Coronary Syndrome

Summary: the primary objective of the study focuses on the kinetics of plasma crp measured during the overall management (before the angioplasty procedure until the discharge of hospitalization) of patients with st+ acs requiring emergency transluminal angioplasty.

during the management of acute coronary syndrome with st segment elevation (acs-st+), an ischemia-reperfusion syndrome is observed in connection with primary coronary occlusion (ischemia) and percutaneous angioplasty during the therapeutic coronary reperfusion. this ischemia-reperfusion syndrome results biologically in an inflammatory syndrome evaluated in particular by the assay of c-reactive protein (crp). crp is a marker of inflammation used in routine practice. previous studies have reported the prognostic value of crp at the 48th hour of hospital treatment for st+ acs. if the value of crp is correlated with the risk of mortality and heart failure, the fact remains that no study has, to date, studied its kinetics during the overall management (pre and intra-hospital) of acs st+. this is all the more important since the previous therapies taken by the patient (statins for example) and/or those administered during treatment (colchicine, ticagrelor, anti-gpiibiiia are capable of modifying the pre-hospital value of the crp. in this study, the kinetics of plasma crp measured during the first medical contact (emergency, cardiology or resuscitation), then, in the catheterization room before the angioplasty procedure, then in the catheterization room, after the angioplasty, then at the 6th hour (h6), at the 12th hour (h12), at the 24th hour (h24), at the 48th hour (h48) and once a week until the 7th day then once a week until discharge hospitalization with a maximum of 30 days of follow-up, as part of the usual follow-up of patients with st+ acs requiring emergency transluminal angioplasty.

Eligibility criteria:
inclusion criteria: * age over 18 years old; * st+ acs requiring emergency transluminal angioplasty; * affiliation to a social security scheme or beneficiary. exclusion criteria: * st+ acs not requiring emergency transluminal angioplasty; * pregnancy; * under guardianship or curatorship; * foreign patient under french ame scheme.

Keywords: acute coronary syndrome c reactive protein kinetic adults
effect of ly333531 on vascular and neural functions

Conditions: Diabetes Mellitus

Summary: to determine if protein kinase c beta plays a significant role in vascular endothelial dysfunction, small fiber neural dysfunction, and oxidative stress associated with diabetes mellitus.

32mg ruboxistaurin; 4 week cross-over treatment.

Eligibility criteria:
inclusion criteria: * type 2 diabetes diagnosed for at least 1 mo and less than 10 yrs prior to visit 1 * hba1c less than 9% and fasting plasma glucose less than 260mg/dl * blood pressure less than 160/100 mmhg * total cholesterol less than 300 mg/dl and/or triglycerides less than 600 mg/dl exclusion criteria: * subjects treated with a thiazolidinedione (tzd) in 12 weeks prior to visit 1. * history of heart disease (mi, unstable angina, cva, tia, cabg, or percutaneous transluminal coronary angioplasty) w/in 6 months of visit 1 or subjects with byha class iii or iv congestive heart failure. * female subjects of child-bearing potential that are pregnant or intend to become pregnant (i.e. not practicing an acceptable method of birth control) * tsh greater than 1.5 times upper limit of normal at v1 or other endocrine disease. * alt greater than 1.5 times upper limit of normal at v1; serum creatinine greater than 2.0mg/dl at v1; micro-albumin greater than 300.
simple versus radical hysterectomy for stage i cervical cancer

Conditions: Cervical Cancer

Summary: the primary objective of this study is to assess the preferences (values and utilities) of women for complications and recurrences associated with the surgical treatment of cervical cancer. a secondary objective of this study is to compare the preferences of women at high-risk for developing cervix cancer with the preferences of women who have already been diagnosed with cervix cancer.

you will be asked to undergo a face to face interview. during the interview, you will be asked questions about your values and feelings about your health status. you will be shown a "feeling thermometer" and asked to rate how your health condition makes you feel. you will also be asked to rate how some of the risks of treatment of cervix cancer make you feel. you will be shown a "chance board" and asked to consider some of the possible outcomes of the disease and possible risks associated with the treatment of cervix cancer. you will be asked to consider the likelihood of achieving certain outcomes and of developing certain side effects due to the disease and/or treatment. the interview will take place in a private room in the clinic and should take around 20 minutes to complete. this is an investigational study. as many as 96 women will participate in this study. up to 48 women who are at high risk of developing cervix cancer and up to 48 women who have been diagnosed with cervix cancer will participate. all will be enrolled at m. d. anderson.

Eligibility criteria:
inclusion criteria: 1. women who are at least 18 years of age. 2. women who speak english 3. women presenting to the colposcopy clinic in the gynecologic oncology clinic at m.d. anderson cancer center or women with an established diagnosis of either stage ia2 or ib1 cervix cancer treated with radical hysterectomy 3-24 months prior to presenting to the gynecologic oncology exclusion criteria: 1. women who are not 18 years of age. 2. women who are non-english speakers. 3. women with a diagnosis of any type of cancer other than cervical cancer. 4. women who are currently pregnant.

Keywords: cervical cancer hysterectomy interview