Kornimate/medical-research-clean huggingface dataset:
the croco study: crohn's disease cohort study

Conditions: Crohn Disease

Summary: the investigators propose to create a prospective crohn disease cohort, where patients receiving the most up-to-date therapies with a treat-to-target strategy, will be closely followed to characterize the progression of crohn disease by measuring the lémann index over time. the goal of the croco study - "crohn's disease cohort study" is to promote a greater understanding of the long-term evolution of crohn disease , to describe prospectively the impact of different therapeutic strategies and develop accurate predictors of bowel disease damage and disability.

therefore, the investigators designed a prospective, multicentre, study of the clinical course, anatomical progression and treatment of newly diagnosed cd and plan to include 600 patients over a 2-year period. patients will be followed over 5 years after diagnosis (the date of diagnosis will be the date of the index histopathology describing cd; in special situations where pathology is not available the date of diagnosis will be the date that cd was declared by the physician). a morphological evaluation (li), using abdominal magnetic resonance, will be performed at 1, 3 and 5 years after diagnosis. ileocolonoscopy, upper endoscopy and/or pelvic mri will be included according to disease location. patients will be treated with standard of care therapy and will be followed for 5 years after diagnosis, with semestrial visits after the year 1 (li 1). at each visit, clinical and laboratory markers will be collected. perianal and abdominal surgeries during follow-up will be registered. the disability index questionnaire will also be recorded every year. a preliminary requisite is therefore to implement and standardize examination reports and damage definitions used to calculate the li. to this end, training session, supervised by members of the steering committee, will be held for participating gastroenterologist and radiologists. based on commented ileocolonoscopy, upper endoscopy abdominal mri and pelvic mri, these sessions will highlight how lesions should be characterized and graded accordingly to implement the lémann index.

Eligibility criteria:
inclusion criteria to be eligible all of the following criteria must be met: * diagnosis of cd (according to ecco guidelines) established within the past 12 months; * patients able to understand the information provided to them and to give written informed consent for the study; * male or female, age \> 18 years. exclusion criteria: * patients unwilling or unable to provide informed, written consent; * severe underlying medical disorder with an anticipated life expectancy \< 2 years; * refusal or medical conditions (e.g. glomerular filtration rate \< 30 ml/min) preventing cross-sectional imaging during follow-up; * uncertain cd diagnosis; * pregnancy (if it is impossible to implement the mre at one year) or any other reason that makes resonance not feasible throughout the study (eg claustrophobia).

Keywords: crohn dii
treatment outcome of uveitis in autoimmune diseases

Conditions: Autoimmune Uveitis

Summary: reviewing the outcomes of patients with uveitis caused by autoimmune diseases treated at assiut university hospital at the ophthalmology and rheumatology and rehabilitation departments.

autoimmune uveitis (au) is an inflammation of the uvea caused by either an autoimmune reaction to self-antigens or an innate inflammatory reaction secondary to an external stimulus. corticosteroids are considered the gold standard in management of acute au, but it is necessary to combine them with other immunosuppressive drugs. finally, biological anti-inflammatory agents (for exapmle antagonists of tumor necrosis factor alpha like infliximab and adalimumab) are also showing very promising results. follow-up visits of subjects with uveitis must be frequent and focused on monitoring the recurrence of acute outbreaks, , if any. they should be aimed to determine the evolution of inflammatory signs until their complete resolution, thus ensuring the least possible consequences. after the initial phase of the treatment, the duration of use of the maintenance medication is directly related to the diagnosis, treatment and control of the underlying disease. this will help to determine if a patient is badly controlled and requires a more aggressive therapeutic plan. also, a complete physical exam must be done each time the patient sees to the physician in order to monitor ophthalmological complications or development of adverse effects secondary to the treatment.

Eligibility criteria:
inclusion criteria: * uveitis with clinical features of autoimmune disease; exclusion criteria: * other infectious and non-infectious uveitic etiologies that may mimic the given clinical presentation of autoimmune uveitis;
analysis in the emergency between transvenous cardiac pacing guided by fluoroscopy versus echocardiogram

Conditions: Bradycardia

Summary: a lot of questions about use of temporary transvenous pacing still remain obscure and there is no effective comparison between use of fluoroscopy versus electrocardiogram/echocardiogram in patients with bradicardias. the aim of the study is to evaluate how long does it take to start the correct cardiac stimulation with transvenous pacing in patients with bradicardias comparing use of fluoroscopy versus electrocardiogram/echocardiogram and compare rates of complications between two methods.

approximately 150 subjects will be recruited over a planned recruitment period of 18 months. patients will be submitted to ecchocardiogram using philips envisor, and electrocardiogram with philips healthcare pagewriter tc30.

Eligibility criteria:
inclusion criteria: * adult males and females aged \> 18 years * symptomatic bradicardia * informed consent signed. exclusion criteria: * pregnancy * hemodynamic instability (pulmonary congestion / systolic arterial pressure lower than 90 mmhg) * body mass index greater than 40 kg/ m2 * use of oral anticoagulation * acute coronary syndromes * left ventricle ejection fraction \< 45% * presence of any kind of cardiac stimulation device

Keywords: echocardiogram electrocardiogram: electrical alternans fluoroscopy
st. john's wort for the treatment of generalized social anxiety disorder (gsad)

Conditions: Anxiety Disorders; Mental Health

Summary: this study will determine whether the herbal product st. john's wort is safe and effective in treating generalized social anxiety disorder (gsad). study hypothesis: hypericum perforatum (st. john's wort) is more effective in treating gsad than placebo.

the use of complementary and alternative medicine (cam) has grown dramatically over the last decade. botanical treatments originating from plants have become especially popular for treating conditions such as anxiety and depression. evidence suggests that the botanical st. john's wort has neurochemical activity similar to that of conventional medications. however, research on the safety and effectiveness of st. john's wort is limited. this study will determine the safety and effectiveness of st. john's wort in treating gsad, a serious condition characterized by intense fear of various social situations that may cause embarrassment. participants will be randomly assigned to receive either st. john's wort or placebo daily for 10 weeks. self-report scales will be used to assess participants' gsad symptoms at study entry and at study completion. blood collection will occur at every weekly study visit to determine the levels of st. john's wort in the blood.

Eligibility criteria:
inclusion criteria: * diagnosis of gsad * brief social phobia scale (bsps) score of 20 or higher exclusion criteria: * comorbid anxiety, depressive, or bipolar disorders * schizophrenia * cognitive impairment * substance abuse or dependence within 1 year prior to study entry * any unstable medical condition * clinically significant laboratory or electrocardiogram (ekg) abnormality * currently use psychotropic medications or may need psychotropic medication during the study * psychotherapy within 6 weeks prior to study entry * failed a previous trial of st. john's wort at doses of 1800 mg/day or greater * pregnancy or breastfeeding

Keywords: social anxiety disorder social phobia generalized anxiety disorder hypericum st. john's wort medicine, herbal complementary therapies
laparoscopic suture versus mesh rectopexy for the treatment of persistent complete rectal prolapse in children

Conditions: Rectal Prolapse

Summary: purpose: to compare laparoscopic mesh rectopexy with laparoscopic suture rectopexy the operative time, recurrence rate, post-operative constipation, and effect on fecal incontinence, were reported and evaluated for each group results:

purpose: to compare laparoscopic mesh rectopexy with laparoscopic suture rectopexy patient and methods: the prospective study was conducted at pediatric surgery department, al-azhar university hospitals, cairo, egypt . the operative time, recurrence rate, post-operative constipation, and effect on fecal incontinence, were reported and evaluated for each group

Eligibility criteria:
inclusion criteria: children with persistant complete rectal prolapse. * failure of conservative treatment. * more than 2 attacks of prolapse requiring manual reduction. exclusion criteria: * sever constipation * previous abdominal or pelvic surgery with extensive adhesions. * cases older than 12ys, * patients with rectal polyp

Keywords: rectal prolapse laparoscopy mesh rectopexy pediatrics
cinematherapy for women with depression and anxiety

Conditions: Depression Anxiety Disorder

Summary: group cinematherapy program in reducing depressive and anxiety symptoms in women diagnosed with depressive disorders and anxiety disorders.

cinematherapy is a creative therapeutic intervention in which a trained professional prescribes the patient to watch a film and uses the characters and themes as metaphors to promote self-exploration and change. the effectiveness of cinematherapy as a therapeutic technique has been demonstrated through its effectiveness in improving participants' self-esteem, emotional expression and understanding, and interpersonal relationships, and in reducing depressive and anxious symptoms.the cinematherapy intervention involves a targeted selection of film content and activities designed to improve the patients' mental condition.the study includes eight meetings on a monthly basis (programming of eight films lasting approximately two hours and subsequent discussion on the contents of the film shown).

Eligibility criteria:
inclusion criteria: * female, aged 18-75 years; * diagnosis of depressive disorders (unipolar and bipolar) and anxiety disorders according to the criteria of the diagnostic and statistical manual of mental disorders - fifth edition (dsm-5), both new onset in subjects without a previous psychiatric history, and depressive and anxious recurrences; * taking psychopharmacological therapy; * fluent knowledge of the italian language; * release of a written informed consent, signed by the patient or legal representative and partner. exclusion criteria: * diagnosis of schizophrenia or other psychotic spectrum disorders; * diagnosis of neurological disorders associated with cognitive decline; * current abuse of alcohol and psychotropic substances, with the exception of smoking; * refusal to sign the informed consent to participate in the study.
hearing loss and osteoporosis

Conditions: Hearing Loss; Osteoporosis, Postmenopausal

Summary: to compare the audiological profiles in postmenopausal women with and without osteoporosis and to examine the pattern of hearing loss in osteoporotic patients. postmenopausal women will be separated as normal, osteopenic and osteoporotic according to bone mineral densitometry results. the evaluation of hearing test will be done in these groups and the results will be compared between the groups.


Eligibility criteria:
inclusion criteria: * between 45-60 years * postmenopausal women exclusion criteria: * women over 60 years old, * acute or chronic otitis media, * ear surgery, * use of ototoxic drugs, * congenital hearing loss, * previous long-term steroid use, * malignant or benign neoplasm of the brain, * patients with a history of exposure to noise were excluded from the study.

Keywords: bone mineral density postmenopause
healthy effects of an innovative probiotic pasta

Conditions: OBESITY; INFLAMMATION; DYSLIPIDEMIA; CONSTIPATION

Summary: the aim of the project was the evaluation of the antioxidant and anti-inflammatory effects of a whole grain pasta, enriched in barley β-glucans and fortified with strains of bacillus coagulans, versus a control wheat pasta on healthy volunteers, using a parallel randomized controlled trial.

epidemiological evidences indicate that consumption of whole grains products is associated to a decreased risk for common chronic diseases, as cardiovascular diseases, diabetes, obesity, hypertension and metabolic syndrome. in the present study a whole grain pasta was supplemented with prebiotics and probiotics 'ad hoc' formulated. in detail, pasta was industrially developed after the identification of particular cultivars of wheat and barley, rich in carotenoids, β-glucans (2.6 g/100g pasta), not soluble fibers and antioxidants. further, pasta was supplemented with spores of bacillus coagulans, a putative probiotic microorganism, belonging to lactobacillus family. it is well demonstrated the ability of this microorganism to survive to technological processes and to upper gastro-intesinal tract, in order to exert beneficial effects in the lower gut, as anti-microbial activity, increasing immunological defences as well as improvements in intestinal regularity. conversely, the control pasta was made from the same cultivar of grain and by the same technological process, but without any supplementation. in this parallel randomized controlled one arm trial, 40 healthy volunteers were randomly allocated for the consumption of the two kind of pasta once a day, for 12 weeks. at the beginning of the study and every 4 weeks, subjects were asked to provide blood, urine and feces for the evaluation of: * blood inflammation markers; * blood lipid and carbohydrate profile; * blood and urine markers of cardiovascular risk; * feces profile of microbiota and detection of markers for the healthiness of the gut. in addition, volunteers filled in different questionnaires regarding their dietary habits, the physical activity and the gut healthiness.

Eligibility criteria:
inclusion criteria: * overweight / obesity * lower consumers of fruit and vegetables exclusion criteria: * antibiotic treatment within 3 months prior the pasta feeding * chronic diseases * surgeries * consumer of whole grain products * dieting * pregnant or lactating
imp321 (eftilagimod alpha) as adjunctive to a standard chemotherapy paclitaxel metastatic breast carcinoma

Conditions: Adenocarcinoma Breast Stage IV

Summary: the proposed phase iib clinical study aims to investigate the safety and efficacy of the active immunotherapy imp321 in combination (adjunctive) with paclitaxel chemotherapy in patients with hormone receptor-positive metastatic breast cancer.

this is a multicentre, placebo-controlled, double-blind, 1:1 randomised phase iib study in female hormone receptor-positive metastatic breast cancer patients. the study comprises of two stages. stage 1 is the open-label, safety run-in stage consisting of cohort 1 and 2 to confirm the (rptd) of imp321 in combination with paclitaxel. stage 2 is placebo-controlled, double-blind randomisation stage, paclitaxel + imp321 at the rptd will be compared to paclitaxel + placebo.

Eligibility criteria:
inclusion criteria: 1. able to give written informed consent and to comply with the protocol 2. metastatic oestrogen receptor positive and/or progesterone receptor positive breast adenocarcinoma, histologically proven by biopsy of the primary tumour and/or metastasis 3. female of age 18 years or above 4. patients who are indicated to received first line chemotherapy with weekly paclitaxel 5. evidence of measurable disease as defined by response evaluation criteria version 1.1 6 laboratory criteria: haematology and biochemistry results within the limits normally expected for the patient population. exclusion criteria: 1. prior chemotherapy for metastatic breast adenocarcinoma 2. disease-free interval of less than twelve months from the last dose of adjuvant chemotherapy 3. inflammatory carcinoma 4. candidate for treatment with trastuzumab (or other her2/neu targeted agents) 5. systemic chemotherapy, radiation therapy or any other investigational agent within 4 weeks, endocrine therapy within 1 week prior to first dose of study treatment or cdk4/6 inhibitors within 5 times half-life (acc.to spc) prior to first dose of study treatment and until completion of study treatment 6. symptomatic known cerebral and/or leptomeningeal metastases 7. serious intercurrent infection 8. evidence of severe or uncontrolled cardiac disease (nyha iii-iv) within 6 months prior to first dose of study treatment 9. active acute or chronic infection 10. active autoimmune disease requiring immunosuppressive therapy 11. previous malignancies within the last three years other than breast carcinoma 12. patients with prior organ or stem cell transplantation 13. any condition requiring continuous systemic treatment with either corticosteroids or other immunosuppressive medications within 4 weeks prior to first dose of study treatment.

Keywords: hormone receptor positive
sleep disruption pattern - epilepsy monitoring unit

Conditions: Epilepsy Intractable

Summary: epilepsy affects millions worldwide, with 40% of patients experiencing uncontrolled seizures despite medication. comprehensive epilepsy centers recommend continuous video-electroencephalography monitoring to define seizure type and distinguish mimickers. this process, however, is resource-intensive, with lengthy hospital stays. the investigators' recent study identified a heightened association between arousals and epileptic activity in drug-resistant focal epilepsy patients. building on these findings, the investigators aim to explore whether disrupting sleep with an alarm system triggers earlier occurrence of seizures, potentially offering insights to reduce hospital stay durations in epilepsy monitoring units.


Eligibility criteria:
inclusion criteria: * age 14 to 60 years * emu monitoring for presurgical evaluations * average 2-3 seizures per week based on pre-admission seizure diary * sleep as a known seizure trigger exclusion criteria: - multiple seizures a day based on pre-admission seizure diary

Keywords: epilepsy monitoring unit
blood fibrocytes during an exacerbation and lung function decline in patients with copd in primary care.

Conditions: Chronic Obstructive Pulmonary Disease

Summary: this study aims to estimate the association between blood fibrocytes measured during a suspected exacerbation and 3-year decline forced expiratory volume in one second (fev1), in patients with chronic obstructive pulmonary disease (copd) in primary care, with a history of smoking, independently of the number of exacerbations and of tobacco or occupational exposure.

copd is highly prevalent in primary care. it is associated with tobacco smoke or toxic occupational exposure. some copd patients will experience a faster decline in quality of life and lung function. there is currently no prognostic marker allowing to identify those patients at higher risk of fast lung function decline. recent data suggest that fibrocytes are involved in copd's physiopathology. a higher blood fibrocytes level during an acute exacerbation has been associated with higher mortality in copd patients at a late stage of the disease. in mice, fibrocytes role in lung function decline has been demonstrated at an early stage. to date, association between blood fibrocytes during an exacerbation and lung function decline has not been evaluated at the early stage of copd in humans. this study aims to estimate the association between blood fibrocytes measured during a suspected exacerbation and 3-year decline in forced expiratory volume in one second (fev1), in patients with copd in primary care, with a history of smoking, independently of the number of exacerbations and of tobacco or occupational exposure. in this study, blood fibrocytes during a suspected exacerbation will be measured at inclusion. the lung function (fev1) will be assessed at follow-up visits at 2 months, 12 months and 36 months after inclusion. copd-related health status and severity of dyspnea will be assessed with copd assessment test (cat) and the modified medical research council dyspnea scale (mmrc) at follow-up visits at 2 months, 12 months and 36 months after inclusion.

Eligibility criteria:
inclusion criteria: * man or woman aged more than 40 years old, * with tobacco exposure of more than 20 pack-years, * presenting to a general practitioner with a suspected mild or moderate copd exacerbation according to global initiative for chronic obstructive lung disease (gold) guidelines (worsening of symptoms with the need for prescribing short acting bronchodilatators, antibiotics or oral corticosteroids) * informed consent given * affiliated to a social insurance scheme exclusion criteria: * severe exacerbation of copd according to gold guidelines (patient requires hospitalization or visits to the emergency room), * more likely differential diagnosis than a copd exacerbation, such as pneumonia, acute pulmonary oedema or other differential diagnosis, * history of asthma, pulmonary fibrosis, primary pulmonary hypertension or chronic viral infections (hiv, hepatitis) * person under care or protection of vulnerable adults

Keywords: pulmonary disease chronic obstructive primary health care fibrocyte respiratory function tests
a retrospective study of early postoperative mobilization in the recovery of patients with oral head and neck tumors who underwent flap reconstruction

Conditions: Length of Hospital Stay

Summary: all patients with head and neck cancers and osteomyelitis who underwent vascularized flap reconstruction at shanghai ninth people's hospital (north campus), shanghai jiao tong university, from february 2020 to july 2021 were the object of a retrospective data collection.depending on whether they had postoperative early mobilization, all patients were split into experimental and control groups.in the experimental group, patients were split into two groups based on the postoperative day(pod): the pod 0-1 group and the pod \>1 group.comparison and analysis were done on the difference in hospital days and post-operative complication rates between the two groups.


Eligibility criteria:
inclusion criteria: 1. patients with head and neck diseases undergoing flap reconstruction and repair 2. patients with complete data preservation and consent 3. patients who follow medical advice during hospitalization exclusion criteria: 1. patients who survived less than 1 month after surgery 2. patients with other tumors before surgery 3, mental patients, audio-visual impairment or uncooperative patients