Kornimate/medical-research-clean huggingface dataset:
training and supervision program for depression management

Conditions: Depression

Summary: according to the literature the management of depressive disorders at primary care level is not always consistent with guidelines. the main objective of this study is to test whether a comprehensive technology-assisted training and supervision program will improve depression management in primary health care clinics in santiago, chile.

a cluster randomized controlled clinical trial will be conducted in four primary health care (phc) clinics in santiago, chile. the sample selection of the phc clinics will be performed in two steps. firstly, two urban municipalities of santiago metropolitan region, chile, will be randomly selected if they work with the faculty of medicine of the u.chile and have at least two phc.municipalities with a high human development index, high percentage of immigrants and older population, and psychiatry residents working in phc , will be excluded.secondly in each selected municipalities,two phc will be randomly selected for the active and control arm. to detect a difference of 20%, in a one-sided model, with an alpha of 5% and power of 80%, 152 depressed persons, 76 to each group, will be required for the study. a design effect of 2.42 was estimated. after applying the design effect the sample needed increased to 368 depressed persons. considering a retention rate of approximately 85%, 434 depressed cases will be needed required for the study, hence 109 cases in each of the 4 primary health care clinics. analysis and presentation of the results will be in accordance with consort guidelines for randomized clinical trials, with the primary comparative analysis being conducted on an intention to treat basis and due emphasis placed on confidence intervals for the between-arm comparisons. initially descriptive analysis to assess the balance between two groups will be conducted. the primary analysis will employ multilevel multivariable lineal regression to investigate differences in the phq-9 scores between groups at 3 and 6 months after randomization, adjusting for baseline outcome variable scores. sensitivity analysis making different assumptions will be conducted to investigate the potential effects of missing data. similar analysis will be done for the secondary outcomes measures.

Eligibility criteria:
inclusion criteria: * signing written informed consent * age between 18-65 years * current depressive episode, according to the mini-international neuropsychiatric interview (mini) exclusion criteria: * current depression treatment * no access to telephone

Keywords: depression
study of the synergistic effects of biofeedback and transcranial electrical stimulation in anxio-depressive disorders

Conditions: Anxiety Depression

Summary: anxio-depressive disorders are characterized by a difficulty in regulating the negative or aversive emotions adequately. these dysfunctions have been linked to a deficit in prefrontal cortex activity. the latter has an inhibitory influence on limbic regions -especially the amygdala- involved in the generation of emotions. by this means, the prefrontal cortex intervenes in the control of the sympathetic and parasympathetic branches of the autonomic nervous system whp are responsible for the physiological components of the emotion, including the variations of the cardiac rhythm (hrv: heart rate variability). in emotionally demanding situations, the activity of the prefrontal cortex is generally associated with an increase in parasympathetic activity that is exerted by stimulation of the vagus nerve. in patients with anxio-depressive disorder, there is a decrease in the activity of the autonomic nervous system whose variability in heart rate is a recognized marker. many studies show a beneficial impact of transcranial direct current stimulation (t-dcs) on anxio-depressive symptoms, particularly when a particular area is targeted: the dorso-lateral prefrontal cortex. the impacts of this intervention are multiple and aim in particular to modulate the activity of the autonomic nervous system to promote regulation. biofeedback hrv is a technique that allows you to learn how to modulate your heart rate by means of respiratory control exercises. the patient receives an immediate feedback on the effectiveness of his learning (basic principle of bio-feedback). this intervention will allow to act on the parasympathetic activity and to promote a vagal tone adequate to the emotional regulation. numerous studies have demonstrated the favorable impact of hrv biofeedback on the reduction of anxious and depressive symptoms. since the vagus nerve seems to be a primary pathway in physiologically emotional regulation, and considering that vagal tone can be stimulated by both the activity of the prefrontal cortex and through respiratory control, it appears interesting to study the association of t-dcs with hrv biofeedback techniques. the first objective of this study is to show that hrv biofeedback training coupled with t-dcs is associated with a greater decrease in anxious symptomatology. the secondary objective of the study is to show that a coupling of these two techniques is associated with an increase of the variability of the cardiac rhythm as well as a more important decrease of the depressive symptomatology.


Eligibility criteria:
inclusion criteria: * diagnose of anxio-depressive disorder * good understanding of french * high anxiety level (stai questionnaire score higher to 46) with reported difficulties to manage this anxiety. exclusion criteria: * alcohol dependence (assessed by the audit questionnaire) * pregnancy * t-dcs contra indications : traumatic brain injury, epilepsy, known bipolar disease, electronic or metalic implant * known cardiac arrhythmia or intake of beta-blockers
ai assessment and prediction models for geriatric trauma

Conditions: Trauma; Aging

Summary: to fill up the research gaps and build up a healthcare service model for geriatric trauma patients, this two-stage study aims to (a) develop geriatric trauma artificial intelligence (ai) prediction models by comparing the outcomes from clinical assessment and ai joint images; and (b) examine the long-term effects of an innovative health service program in geriatric trauma patients.

background: about 40% trauma patients will be over age 65 years by 2050, thus geriatric trauma constitutes an increasingly recognized problem that should be concerned. however, little is known about complicated causes of injury and long-term outcomes in older injured patients. previous study strategies to promote health outcomes for geriatric trauma still are inconclusive. due to the limited healthcare resources and workforce, health service for geriatric trauma care should be refined in the new era. expected outcomes/impacts: this study attempts to build up a modern healthcare model that may influence geriatric trauma care as well geriatric assessment. the ai prediction model can be used to quickly assess "degree of balance" for geriatric trauma patients. this study will involve a nursing student and healthcare professionals, and help them to learn how ai connects to geriatric trauma care. this would be an opportunity to cultivate potential experts for ai and healthcare. last, the outcomes are highly associated with the government's policies related to smart health, smart healthcare, and long-term care workforce.

Eligibility criteria:
inclusion criteria: * admitted to the hospital due to injury first time * able to communicate in mandarin * agree to participate in this study from hospital discharge to one month after hospital discharge * patients and their primary caregivers have smart mobile phones and internet access available * can move independently before trauma exclusion criteria: * not frequent user for smart phones * severe cognitive impairment * victims of hangings and poisonings
observation of acute cardiopulmonary effects in healthy individuals performing cardiopulmonary exercise test (cpx) during whole body vibration (wbv)

Conditions: Acute Cardiopulmonary Effects

Summary: observational study to evaluate acute cardiopulmonary effects of oscillatory whole body vibration (wbv) on healthy individuals analysed in non-invasive cardiopulmonary exercise test (cpx).

oscillatory whole-body vibration (wbv) is a novel exercise modality, which is performed on a vibrating platform that moves in sinusoidal oscillations, and during which static and dynamic exercises can be performed. rapid movements of the platform lead to muscle spindle reﬂexes, which result in reﬂectory contraction of muscle groups and thus promote gain of muscle strength and power. the most efﬁcient vibration rate enhancing muscle function is assumed to be ∼20 hz, leading to constant muscle contraction and anaerobic metabolism of the affected muscle ﬁbres. as a consequence, lactate liberation serves as a stimulus for muscle gain.this methodology has been successfully utilised to enhance moving velocity, muscle power and strength in young athletes and chronic obstructive pulmonary disease though not been understood in all details. therefore this investigation will help to evaluate acute cardiopulmonary effects of whole body vibration (wbv) on healthy individuals analysed in non-invasive cardiopulmonary exercise test (cpx).

Eligibility criteria:
inclusion criteria: * healthy individuals planning on performing a wbv-training * healthy individuals planning on performing a cpx exclusion criteria: * exclusion to perform cpx * exclusion to perform wbv
field trial of maternal influenza immunization in asia

Conditions: Influenza Human

Summary: this project is designed to assess the efficacy of immunizing women during pregnancy with influenza vaccine on the health of these women during their pregnancy and for 6 months post-partum as well as on the health of their newborn infants during the first 6 months of life. it will be conducted in sarlahi district in southern nepal, a rural area where a number of large scale randomized trials have been conducted over the past 20 years.

this is a community-based, placebo-controlled, individually randomized trial in trial among women who are or who become pregnant in 9 village development committees in sarlahi district, nepal. the study population for this trial will include all women who are identified as pregnant with gestational age between 17 and 34 weeks gestation during a 12-month period in 9 village development committees (vdc) of sarlahi district, nepal. the 9 vdcs include: dhungre khola, karmaiya, hariaun, ghurkauli, sasapur, netraganj, lalbandi, jabdi, and raniganj. the vaccine that will be given will be the most current vaccine at the time of subject enrollment. that is, for women enrolled after october in either study cohort, the vaccine will be switched to the newly available vaccine for that year. the control group will be placebo (saline injection). the justification for the use of a placebo injection in this trial is as follows: there is only one trial (bangladesh) that demonstrates efficacy of influenza vaccination in pregnancy on perinatal outcomes and respiratory morbidity in early infancy. one of the issues with that study is that it was not placebo controlled. the "control" in that study was adult pneumococcal vaccine. it could be that the bangladesh study underestimated the impact of influenza vaccine because the mothers and infants receive some indirect protection from the pneumococcal vaccine. in addition, influenza vaccine is not part of national policy or recommendations in nepal at the current time and ministry of health officials are very interested in the results of our study as they consider their immunization program expansion over the next few years.

Eligibility criteria:
inclusion criteria: * mid to late pregnancy exclusion criteria: * do not intend to deliver in the study area * previous pregnancy in this study

Keywords: influenza immunization pregnancy efficacy pertussis hepatitis e
sleep disorders in idiopathic pulmonary fibrosis

Conditions: Idiopathic Pulmonary Fibrosis

Summary: this diagnostic observational study was conducted to (1) investigate the prevalence of sleep-related breathing disorders and other sleep disorders in idiopathic pulmonary fibrosis in comparison to copd, (2) identify characteristics of symptomatic and prognostic significance in idiopathic pulmonary fibrosis with/without sleep disorders, and (3) evaluate different tools for their ability to assess the risk of co-existing sleep disorders in idiopathic pulmonary fibrosis.


Eligibility criteria:
inclusion criteria: * age \>=18 years * written informed consent * ipf cohort: documented history of ipf with definite or possible uip pattern and signs of emphysema below 10% by hrct (ipf diagnosis according to 2011 ats/ers ipf guidelines) * copd cohort: documented history of copd stage ii group a or b, stage iii or iv, group c or d (gold 2014) exclusion criteria: * long-term oxygen therapy * heart failure nyha stages iii and iv * left ventricular ejection fraction ≤ 45% * pregnancy and/or lactation * acute and/or life-threatening illness (instable angina pectoris, acute pulmonary arterial embolism, myocardial infarction, malignant tumor requiring treatment) * current drug or alcohol abuse * any medical, psychological or other condition impairing the patient's ability to provide informed consent * ipf cohort: acute exacerbation of ipf * ipf cohort: concomitant lung/airway diseases other than ipf (signs of emphysema \>10% by hrct) * copd cohort: acute exacerbation of copd * copd cohort: concomitant lung/airway diseases other than copd (e.g. asthma bronchiale) * healthy cohort: documented history of structural airway or lung disease
vagifem® used for the treatment of atrophic vaginitis due to oestrogen deficiency

Conditions: Menopause; Postmenopausal Vaginal Atrophy

Summary: this study is conducted in europe. the aim of this study is to investigate the self-reported impact of vagifem® (estradiol) treatment on urogenital discomfort in women with atrophic vaginitis due to oestrogen deficiency.


Eligibility criteria:
inclusion criteria: * atrophic vaginitis due to estrogen deficiency * post-menopausal
erlotinib combined with chemotherapy in tki resistant non-small cell lung cancers

Conditions: Carcinoma, Non-Small Cell Lung; EGFR Gene Mutation

Summary: numerous evidences verified that erlotinib could dramatically improve the pfs and os of non-small cell lung cancers who harbor egfr sensitive mutations, however, primary or secondary resistance will be developed after tki treatment, doctors do plenty of researches to overcome tki resistance. fast act-2 study present that, first line erlotinib combined with chemotherapy could improved mos to more than 30 months in nsclcs who harbor egfr sensitive mutations, several study shows that sensitive mutations still exist after tki resistance, because of the next generation tkis(such as bibw2992) are not avaliable at present, agents for met amplification(such as crizotinib) are so expensive that many chinese patients could not support. thus, the investigators hypothesis that, after first line tki treatment, the patients who developed tki resistance could still benefit from second line tki combined with chemotherapy.

the investigators will enroll patients diagnosed with advanced non-squamous,non-small cell lung cancer, patients with egfr tki sensitive mutations and developed tki resistance in first line treatment. after enrollment, the investigators will do biopsy again before second line treatment to find out the potential mechanism of tki resistance, do egfr mutation test for both sensitive and resistant mutation in exon 18, 19, 20 and 21; do kras, braf and pi3k mutation test, do fish for met and her-2, the investigators do all these test to evaluated both primary and secondary resistance, the investigators do all these tests to get an overview for egfr mutation status of each patient who develop tki resistance. for second line treatment, patients will received a 28 days gemcitabine platinum combined with erlotinib scheme, after 4 cycle of combined chemotherapy, patients will receive erlotinib for further treatment until progression disease. for the patients who have stable brain metastases, combined chemotherapy should begin after local treatment, such as whole brain radiotherapy or sterotactic radiosurgery. the main endpoint of this study is mean pfs, second endpoints of this study consist of mean os, 8 week orr.

Eligibility criteria:
inclusion criteria: * advanced non-small cell lung cancer, stage iiib/iv * non-squamous * egfr sensitive mutations, such as exon 19 del, or exon 21 l858r * received first line tkis treatment and developed tki resistance * ecog 0-2 exclusion criteria: * squamous non-small cell lung cancer * patients have unstable brain metastasis, predict survival less than 8 weeks * spinal-cord compression without evidence of stabilisation or treatment * women who were pregnant or lactating; women with a positive or no available pregnancy test result at baseline * patients have any unstable illness that could not receive further treatment

Keywords: tki resistance erlotinib combined chemotherapy
ldr brachytherapy versus sbrt for low and intermediate risk prostate cancer patients

Conditions: Prostate Cancer

Summary: the aim of this trial is to find out if there are any differences in the profiles of acute and late adverse effects among men with low and intermediate risk prostate cancer treated either with low dose-rate brachytherapy or hypofractionated external radiotherapy (cyberknife). also the prostate specific antigen (psa) responses and cost utility of each treatment will be analysed.

prostate cancer (pc) is the most common solid malignancy among the men in the western world. the classification to low, intermediate and high risk groups is determined by the psa, gleason score and clinical tnm status at the moment of diagnosis. there are several treatment options available for patients with low and intermediate risk pc and generally their prognosis is good. the men live long after their radical treatments and they have to live with the possible adverse effects caused by the treatment. in this prospective, randomised clinical trial we are comparing two radiotherapy modalities to find out if there are differences in the acute and late adverse effects among men treated either by low dose-rate (ldr) brachytherapy or hypofractionated external radiotherapy. also the psa-responses and cost utilities will be analysed. the number of patients recruited for the study is 60 and the patients will be randomised 1:1 to each treatment arm.

Eligibility criteria:
inclusion criteria: * biopsy proven adenocarcinoma of the prostate * gleason score ≤ 3+4 * clinical and radiological tnm t1c-2c, n0-x, m0-x, psa ≤ 20ng/ml and who 0-2 * low or intermediate risk prostate cancer according to national comprehensive cancer network (nccn) classification exclusion criteria: * clinical tnm ≥ t3 * gleason score ≥ 4+3 * high risk prostate cancer according to nccn classification * history of cancer (other than pc) during the past 5 years (excluding basalioma and squamocellular carcinoma of the skin) * previous pelvic radiotherapy * previous active treatments of prostate cancer (active surveillance allowed) * bilateral hip prothesis or other implant impedes pelvic tt or mri imaging * clopidogrel medication * poor co-operation * life expectancy \< 5 yrs

Keywords: low risk prostate cancer intermediate risk prostate cancer low dose-rate brachytherapy hypofractionated robotic external beam radiation quality of life
thin wire versus thick wire snare for cold snare polypectomy of diminutive polyps

Conditions: Polyps

Summary: cold snare polypectomy (csp) is now common practice and has proven to be a safe and effective technique for removal of diminutive polyps. both thick and thin wire snares are now commonly used for csp. however, because of their physical characteristics, thick wire snares might leave a higher percentage of residual adenoma at the resection site. since this may result in a higher risk of recurrence, the technique needs to be optimized. experts have suggested that a thin wire snare might be more efficient, with a lower risk of residual adenoma at the resection site and consequently a lower risk of recurrence and interval cancer.

approximately 90% of polyps are smaller than 10 mm. given the risk of transformation of adenomas into invasive cancer over years, it is important that these adenomas are completely resected. this will be a double-blind, prospective, randomized controlled trial. all eligible patients referred for a colonoscopy will be able to participate. there will be 2 treatment arms, one arm will be treated with a thin wire snare and the other with a thick wire snare. patients will be randomised through a computer generated programme and blinded for the type of snare used. the treatment arm will be disclosed to the proceduralist after introduction of the colonoscope into the rectum. after resection of the polyp the defect will be carefully examined by the proceduralist. in case of suspicion of residual adenomatous tissue, a re-excision will be performed. if there's a protrusion noticeable at the resection site, this will be biopsied. ultimately, the margins of the defect will be biopsied on either side for histological confirmation of complete removal.

Eligibility criteria:
inclusion criteria: * patients able to give informed consent to involvement in trial. for patients who do not speak english, an interpreter will be asked to translate the informed consent * patients referred to auburn hospital endoscopy unit for a colonoscopy for whatever reason * at least 1 lesion \<10mm beyond the rectosigmoid junction without any endoscopic features of malignancy * at least 1 lesion \<10mm beyond the rectosigmoid junction that according to the proceduralist, can be safely removed with csp exclusion criteria: * current use of antiplatelets (excluding aspirin) or anticoagulants which have not appropriately been interrupted * known coagulopathy * pregnancy * if any doubt about the benign character of the polyp, the patient will be excluded from the study

Keywords: snare polypectomy
the long qt syndrome in pregnancy

Conditions: Long QT Syndrome

Summary: long qt syndrome (lqts) is a disease of young adults and can affect women of child bearing age. suffers of lqts are at risk of ventricular dysrhythmias including torsades de pointes and ventricular fibrillation. pregnancy increases the chance that any mother may have an abnormal heart rhythm or arrhythmia. this chance is higher with the lqts. there are only a few reported cases of women with the lqts having a baby in the medical literature. this can make it difficult for the doctor caring for a pregnant woman with the long qt syndrome - especially should they need an anesthetic. we would like to study as many women who have had a baby who have the long qt syndrome to give us a better idea of whether there are any arrhythmias occurring at the time of delivery.

this will be a retrospective analysis of all lqts women managed at st. paul's or bc women's who have been pregnant in the last 5 years. these two hospitals both have a provincial role in the care of pregnant women, bc women's as the designated provincial tertiary maternity care referral centre, and st. paul's through its provincial patch clinic. using the data from these two centres should capture the majority of lqts cases in parturients in the province. we will search for these women from the department of anesthesia bc women's consult database, the st. paul's cardiac obstetrical care database, and bc women's health records using international classification of diseases - 10 coding for long qt. then, after obtaining patient consent, review the charts collecting data using the data entry form. the cases will then be compared and any conclusions into the different anesthetic managements made.

Eligibility criteria:
inclusion criteria: * pregnant women with diagnoses of long qt syndrome, romano ward and jervell - lange nielson syndrome who delivered at bc women's hospital or st paul's hospital. exclusion criteria: * non consent to participation in the study * age less than 19 * non english speaker

Keywords: long qt syndrome romano ward jervell-lange nielson syndrome