Kornimate/medical-research-clean huggingface dataset:
estocma, an app used by teachers: an rct

Conditions: Obsessive-Compulsive Disorder

Summary: the aim of the present study is to assess the efficacy of a mobile application called estocma in promoting mental health literacy, reducing stigmatizing attitudes related to the obsessive-compulsive disorder (ocd) and improving teachers' confidence in dealing with students that might have ocd. a parallel, randomized controlled trial with two conditions (experimental and control group) will be carried out in a sample of teachers that work in primary and secondary education. pre-post changes will be assessed. experimental group will use the app until they finish it (within a set period of 10 days), whereas control group will do nothing for 10 days. primarily, it is expected that after the use of the app, participants will show an improvement in ocd-related literacy, stigmatizing attitudes, desired social distance and their comfort, confidence and perceived ability in teaching and handling students with ocd. secondarily, the investigators hypothesize that experimental group might show a reduction in obsessive-compulsive symptoms.

adolescence is a critical stage that is associated with a high vulnerability to developing obsessive-compulsive disorder (ocd). schools are part of the natural developmental context of adolescents, and teachers are involved in their education and personal development. in this sense, teachers play an essential role in the early detection and referral of students with possible obsessional symptoms and will also have to deal with the management of this symptomatology in the classroom. moreover, teachers often have low knowledge of mental health problems and lack strategies for handling mental symptomatology in the classroom. estocma is a mobile health (mhealth) application that has been developed to promote mental health literacy and reduce stigmatizing attitudes associated with ocd. previous studies have shown that it is a tool with great potential in terms of intervention on stigma and ocd literacy in the general population. thus, it could be of great interest to use this app in the field of education, and especially in non-university education since adolescents, a highly vulnerable collective to the development of ocd, spend much of their time in the classroom, and often seek help from school staff.

Eligibility criteria:
inclusion criteria: * being a practising teacher in non-university education. * working in the education field as a guidance counsellor, language teacher or therapeutic pedagogue. exclusion criteria: * working in a field other than those mentioned above. * having less than 18 years old.

Keywords: obsessive-compulsive disorder adolescence mobile app mental health literacy teachers
brazilian total neoadjuvant therapy trial

Conditions: Colorectal Neoplasms

Summary: standard therapy for localized rectal cancer includes chemotherapy and radiation therapy, followed by a "recovery" period of 7-12 weeks, surgery and adjuvant chemotherapy for 3-6 months. even though this protocol achieves high cure rates, many patients need a rectal amputation with placement of definitive colostomies. about 10-20% of patients have a complete clinical response to chemo-radiation and no tumor can be found in the surgical specimen. these patients can be followed with close surveillance and avid surgery. the aim of this study is to evaluate if a strategy including the use of a highly active chemotherapy called "folfirinox" during the 12 weeks between the end of radiation therapy and evaluation for surgery increases the rates of complete response and, therefore, allows more patients to undergo non-surgical management.

adult patients with locally advanced rectal cancer who have completed conventional long-course chemo-radiation of 54gy with capecitabine will be randomized 1:1 to a total neo-adjuvant therapy (tnt) protocol or to a control group. patients in the tnt arm will receive 4 cycles of interval chemotherapy with folfirinox (5-fu, irinotecan, oxaliplatin) between the end of chemo-radiation and re-staging and those in the control group will undergo standard post-radiation care during this period. all patients will be re-staged with colonoscopy and pelvic mri 12 weeks after the end of chemo-radiation. those with a complete clinical response will be placed under a watch-and-wait protocol with digital rectal examinations every 2 months and pelvic mri and sigmoidoscopy every 6 months. those wih residual tumors will undergo resection with total mesorectal excision (tme). patients with a "near complete response", as defined by a multidisciplinary tumor board, will be re-staged at week 16 or 18 after chemo-radiation before undergoing surgery. adjuvant chemotherapy will be done following the local standard of care.

Eligibility criteria:
inclusion criteria: * age \>= 18 y/o * biopsy-confirmed rectal adenocarcinoma * tumor stage t3+ or n+ m0 * adequate liver function (total bilirubin \< = 4.0) * adequate kidney function (calculate creatinine-clearance \>=30ml/m2/min) * adequate bone marrow function (platelet counts \>=90.000, hemoglobin \>=8mg/dl, neutrophile count \>= 1.500/cm3) * completed chemo-radiation with at least 54gy and capecitabine 1650mg/m2/d exclusion criteria: * prior tumor resection * prior radiation to the pelvis * prior chemotherapy for rectal cancer * life expectancy \< 6 months * unfit for surgery * need for urgent/ immediate surgery

Keywords: rectal cancer neoadjuvant chemo-radiation total neoadjuvant therapy watch-and-wait
the relationship between moderate-to-severe psoriasis and sleep disturbance

Conditions: Moderate-to-severe Psoriasis

Summary: psoriasis is a common chronic and systemic immune-mediated disease, induced by a combination of genetic and environmental effects. the increasingly worrying question is the negative impact on patients' sleep, which has become an important comorbidity of psoriasis. to investigate the causal relationship between psoriasis and sleep status, a prospective cohort study will be conducted by separating moderate-to-severe psoriasis patients and healthy individuals into distinct cohorts in order to observe their sleep status.

target follow-up duration for the study is 24 weeks, during which participants will undergo a sleep monitoring session every 8 weeks. the sleep monitoring data collected includes time to fall asleep, time to bed, sleep perception, and the pittsburgh sleep quality index (psqi). the dermatology quality of life index (dlqi), the psoriasis area and severity index (pasi), and the visual analog scale (vas) will simultaneously be used to assess the severity of the disease in the cohort of patients with psoriasis.

Eligibility criteria:
inclusion criteria: 1. in line with the diagnostic criteria of psoriasis 2. pasi\>10 or bsa\>10% 3. understand and agree to participate in this study and sign the informed consent. exclusion criteria: 1. those with serious mental diseases, such as depression, anxiety, etc; 2. psqi\>5 points; 3. long term use of sedative and hypnotic drugs; 4. patients with diabetes mellitus or severe heart, liver and kidney disease; 5. those diagnosed with sleep disorders, such as apnea syndrome, periodic limb movement disorder, restless legs syndrome, narcolepsy, etc; 6. there are serious cardiovascular and cerebrovascular diseases, respiratory system diseases, and immune system diseases; 7. pregnant women during pregnancy, lactation, or planned trials; 8. those who have participated in other clinical studies or are participating in other clinical trials within 3 months; 9. unable to cooperate with the study for any reason, such as the following situation: language understanding, unable to complete the scale tester. if any one of the above items is met, it shall be excluded.
secondary prevention in acute coronary syndromes: a caliber study

Conditions: Acute Coronary Syndrome

Summary: all contemporary guidelines for secondary prevention in acute coronary syndromes recommend a combination of aspirin, beta-blockers, ace-inhibitors and statins. yet underutilisation of these drugs is common. we do not know in detail what drives underutilisation, nor what its long term consequences are for survival after discharge from hospital. also unknown is whether potential adverse effects of underutilisation are the same for individual secondary prevention drugs. this study will assess the impact of secondary prevention underutilisation on survival.

using information from an england and wales audit of acute coronary syndromes (the myocardial ischaemia national audit project (minap)) we aim to assess: (i) survival from first time minap-registered event to death as a function of secondary prevention medications: to what degree do the effects of medications (assumed equal, independent and additive) relate to patient survival? is there evidence of a differential effect of discharge medications? (ii) (a) survival from first time minap-registered event to death or second time minap-registered event as a function of secondary prevention medications: to what degree do the effects of medications (assumed equal, independent and additive) relate to competing risks? is there evidence of a differential effect of discharge medications? (b) survival from first time minap-registered event to death or second time minap-registered phenotyped as stemi, nstemi or unstable angina. to what degree do the effects of medications (assumed equal, independent and additive) relate to competing risks? is there evidence of a differential effect of discharge medications? (iii) what impact would ensuring all medication is taken have on event free survival? this study is part of the caliber (cardiovascular disease research using linked bespoke studies and electronic records) programme funded over 5 years from the nihr and wellcome trust. the central theme of the caliber research is linkage of the myocardial ischaemia national audit project (minap) with primary care (gprd) and other resources. the overarching aim of caliber is to better understand the aetiology and prognosis of specific coronary phenotypes across a range of causal domains, particularly where electronic records provide a contribution beyond traditional studies. caliber has received both ethics approval (ref 09/h0810/16) and ecc approval (ref ecc 2-06(b)/2009 caliber dataset).

Eligibility criteria:
inclusion criteria: * individuals with acute coronary syndrome who have been registered with the minap database. exclusion criteria: * none

Keywords: secondary prevention aspirin beta blocker ace inhibitor statin acute coronary syndrome myocardial infarction unstable angina trends
smoking cessation and reduction in depression

Conditions: Tobacco Smoking in Depressed Patients

Summary: it is well established in studies across several countries that tobacco smoking is more prevalent among depressed patients than the general population. electronic cigarettes are becoming increasingly popular with smokers worldwide. to date there are no large randomized trials of electronic cigarettes in depressed smokers. a well-designed trial is needed to compare efficacy and safety of these products in this special population. we have designed a randomized controlled trial investigating the efficacy and safety of electronic cigarette. the trial will take the form of a prospective 12-month randomized clinical study to evaluate smoking reduction, smoking abstinence and adverse events in depressed smokers not intending to quit. we will also monitor quality of life, neurocognitive functioning and measure participants' perception and satisfaction of the product. outcome measures: a ≥50% reduction in the number of cigarettes/day from baseline, will be calculated at each study visit ("reducers"). abstinence from smoking will be calculated at each study visit ("quitters"). smokers who leave the study protocol before its completion and will carry out the early termination visit or who will not satisfy the criteria of "reducers" and "quitters" will be defined "non responders".


Eligibility criteria:
inclusion criteria: 1. patients with major depressive disorder (mdd) (according to dsm 5 criteria) from throughout sicily (italy), who smoke tobacco cigarettes. 2. smoke ≥10 factory made cig/day, for at least the past five years 3. age 18-65 years 4. in good general health (in absence of cancer, acute myocardial infarction, unstable angina, severe cardiac arrhythmia, recent cerebrovascular incident, or severe atherosclerosis ) 5. not currently attempting to quit smoking or wishing to do so in the next 30 days (a specific test will be included to check their unwillingness to quit) 6 months 6. committed to follow the trial procedures. exclusion criteria: 1. use of smokeless tobacco or nicotine replacement therapy or other smoking cessation therapies 2. pregnancy or breastfeeding 3. current or recent (less than 1 yr) past history of alcohol and/or drug abuse 4. active suicidal intention 5. other significant co-morbidities according to the investigator's clinical assessment (e.g. cancer, acute myocardial infarction, unstable angina, severe cardiac arrhythmia, recent cerebrovascular incident, or severe atherosclerosis
prognostic factors for all types of cancer combined

Conditions: Cancer

Summary: the purpose of this study is to investigate every possible applicability of flow cytometrical analysis in the intracellular detection of tumor-related material in activated macrophages in the broadest range of cancer types.


Eligibility criteria:
inclusion criteria: * (suspicion of) presence of cancer in the broadest sense of the word * must be able to understand and sign written informed consent exclusion criteria: * none

Keywords: cancer occurence cancer recurrence neo-adjuvant treatment response measurement
effect of aerobic training and ginkgo biloba on lipids levels in hiv-positive patients undergoing antiretroviral treatment

Conditions: Human Immunodeficiency Virus

Summary: the administration of antiretroviral drugs (art) has significantly prolonged the life expectancy of people living with human immunodeficiency virus (hiv) and delayed the progression towards acquired immune deficiency syndrome (aids). however, this has led to the emergence of other conditions, such as dyslipidemia, among individuals undergoing art. dyslipidemia is commonly managed with statin therapy, which has not been reported to have pharmacological interactions with art. additionally, ginkgo biloba extract (gbs) has been observed to improve blood lipid concentrations, and aerobic exercise training (exa) interventions have shown positive modifications in these values. given this context, the present study aims to investigate the potential positive effects of an aerobic training program and the consumption of ginkgo biloba extract on plasma lipid concentrations in hiv-positive individuals. the study seeks to provide insights into novel strategies for managing dyslipidemia in this population.


Eligibility criteria:
inclusion criteria: * ages 18 to 60 years * diagnosis of hiv-1 infection * receiving antiretroviral therapy with a triple regimen (biktarvy treatment) * undetectable viral load (\ 200 cells/μl * diagnosis of mixed dyslipidemia in the last three months, indicated by: * total cholesterol ≥ 200 mg/dl * hdl cholesterol \< 40 mg/dl in men and \< 50 mg/dl in women * ldl cholesterol \> 100 mg/dl * triglycerides ≥ 150 mg/dl * possession of a mobile device or computer with internet access and necessary platforms * willingness to participate voluntarily in the study and provide written consent exclusion criteria: * individuals who develop hypersensitivity or allergy to ginkgo biloba extract * failure to attend at least 80% of the physical exercise sessions (equivalent to missing more than 12 sessions) * lack of adherence to pharmacological treatment * participant's decision to discontinue the intervention

Keywords: hiv-positive individuals aerobic exercise training ginkgo biloba extract plasma lipid concentrations
analgesic treatment for cancer pain in south east asia

Conditions: Pain

Summary: this study is planned to investigate the pain control status in cancer patients in 6 south east asian countries through evaluation of prescription pattern of analgesics, satisfaction of pain control, quality of life and assessment of the adequacy of pain control and relationship among these factors in cancer patients with pain. cancer pain is undermanaged and it is hoped that this study will be used as a reference for effective cancer pain management in these countries.


Eligibility criteria:
inclusion criteria: 1. adult (over 18 years) cancer patients \[country variation would be accepted based on the definition of adults\] 2. cancer has been diagnosed pathologically 3. out-patients with cancer pain due to cancer itself or its treatment 4. patients being treated with any analgesics for more than one month for the management of cancer pain at enrolment 5. patients who are willing to voluntarily sign the study consent form exclusion criteria: 1. patients who have had an operation for any reasons within 3 months prior to the enrolment 2. patients with any oncologic emergency 3. patients who had any interventional therapy (e.g. nerve block, neurolytic procedures) related to their cancer pain within 6 weeks of study entry 4. insufficient ability or willingness to cooperate 5. patients who are judged not suitable to participate in this study by the investigator 6. patients who are participating in any other interventional clinical trials for cancer treatment or supportive care

Keywords: pain management, pain control, cancer
effects of continuous positive airway pressure and valsartan treatments on arterial blood pressure in osas patients

Conditions: Hypertension,; Obstructive Sleep Apnea

Summary: the main objective of the study is to compare the decrease of mean arterial blood pressure over 24 hours in patients having obstructive sleep apnea syndrome and weak or moderate hypertension, treated by valsartan 160mg per day versus continuous positive airway pressure.

it is now well known that cardiovascular risks are increased in patients with obstructive sleep apnea syndrome (osas). also a link has already been demonstrated between osas and hypertension. nowadays, the most efficient treatment of the osas is the continuous positive airway pressure (cpap). several studies have also shown that cpap could reduce arterial blood pressure of about 3,3 mmhg in osas patients. unfortunately, 40% of the patients either refuse being treated by cpap or give up treatment. in parallel, alternative medications are proposed to patients with moderate osas and hypertension, in order to decrease their cardiovascular risks. a study led on rats has shown the superiority of the beta adrenergic blocking agents in the decrease of hypertension in osas patients. our study has also the objective to compare the effects of valsartan and cpap on hypertension in osas patients. those one will be randomized either in the group "treatment by valsartan and then by cpap" or in the group "treatment by cpap and then valsartan" (cross-over study).

Eligibility criteria:
inclusion criteria: * male/female over than 18 years old * patient with an obstructive sleep apnea (apnea-hypopnea index \> or equal to 15) * patient with weak or moderate hypertension (140 \<= sbp \< 180 mmhg and 90 \<= dbp \< 110 mmhg). patient with antihypertensive monotherapy must stop their treatment and respect a washout period of at least 4 weeks before the screening visit. for patient treated by antialdosterone, the washout period will be of at least 8 weeks. * negative pregnancy test * ambulatory patient * patient who have signed the informed consent form * patient affiliated to social security exclusion criteria: * pregnant or nursing woman * woman who refuses to use contraceptive method * acute hepatic failure, biliary cirrhosis, cholestasis * clearance of cockcroft \< 30 ml/min/1.73m2 * kaliemia \>= 5.5 mmol/l * acute hypertension (sbp\>= 180 mmhg and/or dbp \>= 110 mmhg) * acute daytime sleepiness (epworth rating scale \> 15) * patient with a profession that is inconsistent with the continuous positive airway pressure (cpap) treatment * known cardiovascular pathologies * contraindication to cpap * allergy to valsartan * patient treated with lithium * patient treated with drug(s) acting on arterial blood pressure * patient on tutelle or curatelle * patient kept in detention, major protected by the law, hospitalised person * patient currently participating in another clinical trial

Keywords: obstructive sleep apnea hypertension ambulatory bloop pressure monitoring
clinical evaluation of instrumented wheel as biomedical device quantifying the displacement efficiency

Conditions: Spinal Cord Injury

Summary: the purpose of this study is to validate an instrumented wheel such as a new biomedical device. the physicians will compare this instrumented wheel with another instrumentation "ergometer roller", each patient will try the both instrumentations, physical and physiological parameters will be measured. the increase rate of radial power during the cardiac stress test may be more important when the physicians use the instrumented wheel.

\* the manual wheelchair is used by people for whom walking is difficult or impossible due to spinal cord lesions, neurological and muscular diseases, lower limb trauma, age ...etc. although the wheelchair help to regain mobility, this made of displacement is nor natural nor well-to-do. * the cic-it and tsr (transmissions services roulements, mérignac, france) improved the instrumented wheel, adaptable with all wheelchairs, with information wireless transmission. * the primary objective of study is to validate the instrumented wheel of manual wheelchair such as a new device of evaluation of capacities of displacement in ecologic situation. * the primary criteria is to compare the mechanical power calculated using instrumented wheel versus the power calculated using ergometer roller during protocol of standard cardio-respiratory stress test. this study is interventional, mono-centric, controlled and crossover. the population concerned is patients with spinal cord injury (sci) and users of manual wheelchair. number of subjects projected for the entire study: 62 patients the total duration of participation of each patient: 7 days ±2days

Eligibility criteria:
inclusion criteria: * age : 18-70 years. * spinal cord injured patient. * user of manual wheelchair for daily locomotion (having at least 30/100 at displacement items of wst questionnaire) . * affiliation to a social security scheme or entitled. * informed consent dated and signed by subject or subject's legally acceptable representative (and investigator). exclusion criteria: * cognitive troubles. * progressive diseases: tumoral, infectious, inflammatory and associated pathologies: brain injury, amputation.

Keywords: instrumented wheel manual wheelchair spinal cord injury (sci) manual wheelchair users aged between 18-70 years