Kornimate/medical-research-clean huggingface dataset:
personalized drinking feedback interventions

Conditions: Alcohol Abuse

Summary: the objective of this research is to better understand how to reduce hazardous drinking among oef/oif veterans by assessing the effectiveness of a low-cost, computer-delivered preventative program.

excessive drinking among oef/oif veterans represents an important public health problem for both the veterans themselves and those with whom they interact. the objective of this research is to better understand how to reduce hazardous drinking among this group by assessing the effectiveness of a low-cost, computer-delivered preventative program. it is hypothesized that an intervention that provides personalized feedback about drinking behaviors will be more effective than an education-only control condition at reducing alcohol use and negative alcohol-related consequences.

Eligibility criteria:
inclusion criteria: * oef/oif veteran exclusion criteria: * none

Keywords: alcohol brief intervention personalized feedback veterans
evaluation of resuscitation markers in trauma patients

Conditions: Trauma; Hypovolemic Shock

Summary: severe trauma patients have an elevated risk of multiple organ failure and death. in order to increase survival possibilities the initial treatment must be focused into resuscitation from shock. traditionally the most common resuscitation markers used are vital signs and urine output. unfortunately, many patients might present normal vital signs, but still undergo a compensated shock with persistent acidosis, hence being able to develop multiple organ failure and death. consequently, it is important to define better resuscitation markers for these patients. this investigation project consists in an observational prospective study, performed by a multidisciplinary team, in which different resuscitation markers are evaluated in severe trauma patients. there will be a specific timing (1st, 8th and 24th hours from arrival) evaluation of different markers: hemodynamic (vital signs, urine output, etc); analytical (lactate, base excess, natriuretic atrial peptide); tissue perfusion markers (nirs); microcirculation markers (videomicroscopy) and coagulopathy markers (thromboelastometry). there will be a registry of total volume administration; blood cell transfusions and vasoactive drug requirements. each marker will be evaluated in relation to mortality; multiple organ failure; massive transfusion protocol activation; blood cell transfusion requirement; surgical control of bleeding requirement and emergent arteriographic embolization. the objective of this study is to demonstrate which of these markers is better to predict hemodynamic evolution of severe trauma patients and might become a guide for resuscitation in the future.


Eligibility criteria:
inclusion criteria: * pre-hospital priority 0 protocol activation: * glasgow coma scale \< 14 * systolic blood pressure \< 90 mmhg * respiratory rate \ 29 breaths per minute * absent peripheral pulses * pre-hospital priority 1 protocol activation: * all penetratin injuries to head, neck, torso and extremities proximal to elbow and knee * flail chest * two or more proximal long-bone fractures * crushed, degloved or mangled extremity * amputation proximal to wrist and ankle * pelvic fracture * open or depressed skull fracture * paralysis exclusion criteria: * hospitalization \< 24 hours ( transport of the patient to an other trauma center) * patients transported from an other hospital (first hours of medical support done elsewhere)

Keywords: microcirculation videomicroscopy spectroscopy, near-infrared b-type natriuretic peptide thromboelastometry trauma resuscitation hypovolemic shock
emotional skills training with social robot

Conditions: Autism Spectrum Disorder

Summary: autism is a neurodevelopmental disorder that involves difficulties especially in the sphere of social interaction, social communication, and restricted and stereotyped behavior patterns. in particular, emotional regulation is a central developmental skill. in fact, the emotional dysregulation observed in children with autism results in increased social and behavioral difficulties over time. therefore, the present protocol aims to test the role of a human-assisted social robot as a mediator of social-emotional understanding intervention for children with autism spectrum disorders (asd). the children, will be divided into two groups, an experimental one in which training will be conducted through the use of social robot and control group which will be conducted through traditional therapy.


Eligibility criteria:
inclusion criteria: * language in sentences * use of connectors * ability to narrate events not present * ados level: module 2 * griffiths: qs\>75 exclusion criteria: * presence of other medical disorders

Keywords: autism children emotional skills social robot
dose optimization of infliximab in moderate to severe plaque psoriasis (study p05315)

Conditions: Psoriasis

Summary: participants from an ongoing observational study (p05319) who have a limited (adequate but less than optimal) response to infliximab will be randomized to either increase the frequency of infliximab infusions from every 8 weeks to every 6 weeks, or to add weekly methotrexate to their current treatment plan. while receiving infliximab study treatment(s), patients in this study will attend regularly scheduled office visits for various clinical tests for safety and effectiveness evaluations.


Eligibility criteria:
inclusion criteria: * subjects must have a diagnosis of moderate to severe plaque-type psoriasis and have had participated in study p05319. * subjects must have demonstrated an adequate but suboptimal response to infliximab in study p05319 * subjects must be at least 18 years old * subjects must be candidates for phototherapy or systemic treatment for psoriasis. * subjects must not be pregnant and must meet contraceptive requirements * subjects must meet tuberculosis screening criteria * subjects must meet laboratory and medical history screening requirements exclusion criteria: * subjects for whom infliximab or methotrexate is contraindicated or not recommended. * subjects already using certain investigational, biological, or immunosuppressive drugs * subjects with certain comorbid conditions * subjects who currently have or have a history of certain infections * subjects who have recently received live virus or bacterial vaccinations * subjects who are in a situation or have any condition that, in the opinion of the investigator, may interfere with optimal participation in the study.
the impact of aerobic interval and inspiratory muscle training on patient reported outcome scores in individuals with chronic constipation

Conditions: Constipation; Constipation by Outlet Obstruction; Constipation-predominant Irritable Bowel Syndrome; Constipation - Functional

Summary: the primary aim of this study will be to determine if the addition of aerobic interval and inspiratory muscle training (imt) targeted at improving cardiopulmonary-based measures will further improve patient satisfaction scores in individuals with chronic constipation (cc) who report plateau or limited improvements in cc after demonstrating a corrected defecation pattern using anorectal biofeedback training.


Eligibility criteria:
inclusion criteria: * adults \>18 years of age * complaint of chronic constipation and associated symptoms * confirmed pelvic floor muscle dyssynergia * willing and able to sign informed consent * ability to comply with study guidelines. * potential subjects must report two or more of the following: straining during more than 25% of defecations, lumpy or hard stools more than 25% of defecations, sensations of incomplete bowel evacuation more than 25% of defecations, manual maneuvers to facilitate more than 25% of defecations, sensation of anorectal obstruction/blockage more than 25% of defecations, and fewer than 3 small bowel movements per week. exclusion criteria: * rectal prolapse greater than grade 2 * pregnancy * cognitive impairments * history or present cardiac condition that would exclude them from moderate intensity exercise * presence of an orthopedic condition with significant severity that the exercise protocol may exacerbate * currently receiving additional physical therapy treatment for conditions associated with pelvic floor muscle dysfunction * recent surgery within the past 3 months without clearance from a medical doctor * medication usage that would interfere with their ability to exercise safely * individuals recovering from a confirmed eating disorder or recent unexplained weight loss \>10lbs within one month.
obstructive sleep apnea syndrome in patients treated for cancer of the upper aerodigestive tract

Conditions: Upper Aerodigestive Tract Neoplasms; Obstructive Sleep Apnea-hypopnea Syndrome

Summary: prospective open-label, non-randomized, monocentric, cohort study, to assess the prevalence and severity of sleep apnea syndrome in patients treated for cancer of the upper aerodigestive tract. the patient follows a usual course of care including, at the end of the treatment of his cancer of the upper aerodigestive tract, screening for obstructive sleep apnea syndrome at 3 months and 6 months (epworth score and ventilatory polygraphy)

prospective open-label, non-randomized, monocentric, cohort study, to assess the prevalence and severity of sleep apnea syndrome in patients treated for cancer of the upper aerodigestive tract. patients are included in the study when they are hospitalized for panendoscopy. thereafter, it takes about 1 month to start any treatment. the duration of treatment is estimated at about 5 months (the longest regimen would be induction chemotherapy followed by surgery and adjuvant complementary treatment). after which the patient follows a usual course of care including, at the end of the treatment of his cancer of the upper aerodigestive tract, screening for obstructive sleep apnea syndrome at 3 months and 6 months (epworth score and ventilatory polygraphy).

Eligibility criteria:
inclusion criteria: * macroscopic lesion suggestive of a cancerous tumour of the upper aerodigestive tract (oral cavity, oropharynx, larynx, hypopharynx, cavum, cervical lymph node metastases with an occult primary cancer) * awaiting anatomopathological confirmation exclusion criteria: * history of cancer of the upper aerodigestive tract * history of known obstructive sleep apnea syndrome * cancer of the thyroid, salivary glands, nose and paranasal sinuses * patients under guardianship or curatorship

Keywords: upper aerodigestive tract neoplasms obstructive sleep apnea-hypopnea syndrome epworth score ventilatory polygraphy
normal values of high frequency ecg (hyperq™) in apparently healthy individuals and in young and masters athletes

Conditions: Healthy; Asymptomatic; Obesity

Summary: the main objective of this study is to investigate depolarization characteristics represented by changes in hyperq in asymptomatic, apparently healthy athletic and non-athletic individuals. we also aim to examine a subgroup of obese and non-obese subjects. the goal of the study is to establish normal hyperq values in these populations and compare hyperq values of age-matched athletic vs. non-athletic individuals of similar health status.


Eligibility criteria:
inclusion criteria: * an asymptomatic, apparently healthy patient performing a maximal exercise stress test exclusion criteria: * contraindications for an exercise test * wolff-parkinson-white (pre-excitation) syndrome * atrial fibrillation or significant ventricular arrhythmia * treatment with digoxin * pacemaker * pregnancy or suspected pregnancy * qrs duration\>120ms or other conduction delays

Keywords: high frequency ecg normal values asymptomatic obese
a study to evaluate the effect of vitamin d supplementation on insulin sensitivity and secretion

Conditions: Diabetes Mellitus, Non-Insulin-Dependent

Summary: the purpose of the study is to evaluate the change in insulin sensitivity and secretion indices (early markers for development of diabetes) after 4 weeks of a megadose of vitamin d. this will also help to calculate sample size for and choose an appropriate index for a larger randomized control trial which may be required subsequently.

accumulating evidence suggests that serum vitamin d levels may be inversely related to the prevalence of diabetes, to the concentration of glucose , insulin resistance and metabolic syndrome.the available trials have been conducted using small sample sizes in different subgroups (hemodialyzed patients , healthy volunteers , gestational diabetes and post menopausal women ) document variable results with a positive result in some (hemodialysis and gestational diabetes) and no effect in other settings(healthy volunteers and postmenopausal women).we therefore, planned this trial to study the effect of vitamin d supplementation (240,000 iu) on insulin secretion and peripheral insulin sensitivity.this will also help to calculate sample size for and choose an appropriate index for a larger randomized control trial which may be required subsequently. study design and comparison:single group, open label intervention trial involving assessment of insulin sensitivity and secretion in 30 volunteers before and after 4weeks of a megadose of vitamin d. the pre and post intervention results will be compared using the paired t test.

Eligibility criteria:
inclusion criteria: * male * ≥30 years of age * waist circumference ≥80 cm exclusion criteria: * diabetic- fasting blood sugar \>126 mg/dl or on anti-diabetic medication * bp\>140/90 or on anti-hypertensive medication * receiving vitamin d or calcium supplementation * chronic disease-renal/hepatic/malignancy/gastrointestinal * on any medication within the last one month which could potentially influence insulin secretion, insulin sensitivity, vitamin d or calcium metabolism * febrile illness or infective morbidity in the past 10 days

Keywords: diabetes vitamin d insulin sensitivity insulin secretion
prospective study of n-acetyltransferase2 (nat2) and cytochrome p4502e1 (cyp2e1) gene as susceptible risk factors for antituberculosis (att) induced hepatitis

Conditions: Pulmonary Tuberculosis

Summary: n-acetyltransferase2 (nat2) and cytochrome p4502e1 (cyp2e1) are two drug metabolizing enzymes. antituberculosis drug isoniazid is acetylated by nat2 and forms ultimately a nontoxic compound which is metabolized by cyp2e1 to a toxic metabolite. slow acetylator genotype of nat2 and wild type genotype of cyp2e1 gene has been attributed to greater toxicity of att drug. therefore this study has been designed to analyze the genetic polymorphism of nat2 and cyp2e1 genes in tuberculosis patients who developed drug induced hepatitis upon administration of antituberculosis drug.polymorphism study of nat2 and cyp2e1 gene may help in predicting the high risk group of att induced hepatitis.


Eligibility criteria:
inclusion criteria: * patients with pulmonary tuberculosis * patients receiving conventional antituberculosis drugs * patients who directly presented with antituberculosis drug induced hepatitis exclusion criteria: * habitual alcohol drinkers * patients with evidence of viral hepatitis
prevention of restenosis after genous stent implantation using a paclitaxel eluting balloon in coronary arteries

Conditions: Coronary Artery Disease

Summary: percutaneous coronary intervention with stent implantation is limited on the one hand by restenosis due to smooth muscle cell proliferation and on the other hand by stent thrombosis due to incomplete or not sufficient enough endothelialization of stent struts. the genous stent implantation allows a rapid layer over the stent struts with endothelial progenitor cells allowing a fast endothelialization and probably reducing the risk of stent thrombosis. local therapy with drug-eluting balloons administering paclitaxel has been shown to reduce restenosis in in-stent restenosis and de-novo lesions in vessels with small reference diameter. the combination of a paclitaxel-eluting balloon and genous stent implantation may summarized both advantages: a rapid endothelialization limiting the number of stent thrombosis and on the other hand a reduction of smooth muscle cell proliferation minimizing the risk of restenosis with the subsequent need for revascularization.


Eligibility criteria:
inclusion criteria: * patients \>18 years old * lesion in native coronary artery * de-novo stenosis * indication for revascularization (angina status, myocardial ischemia, positive stress test, pathologic ffr) * range of reference diameter 2.5 to 4.0mm exclusion criteria: * lesion in saphenous vein graft * chronic total occlusion * bifurcation lesion requiring stenting of main and side branch * left main stenosis * restenosis * in-stent restenosis * contraindication for dual antiplatelet therapy for the following 6 months * coronary aneurysm in target vessel

Keywords: patients with coronary artery disease percutaneous coronary intervention stent implantation paclitaxel eluting balloon angiographic follow-up clinical follow-up
march vascular endothelium substudy

Conditions: Cardiovascular Disease

Summary: this is a substudy of march, in which we are exploring the changes in the vascular endothelium using pulse wave tonometry (a non invasive measure of cardiac health) to measure the changes in small and large arterial elasticity in participants of the march study who switch to maraviroc-based regimens over 96 weeks of follow-up.

cardiovascular disease is increasingly recognised as a complication of hiv +/- therapies to treat it. blood vessel elasticity, or compliance, can be depicted as the ability of the vessels to convert intermittent blood flow (cardiac ejection during systole) to continuous blood flow throughout the cardiac cycle. the compliance, or ability of vessels to accept energy, can be subdivided into elasticity of large and small vessels. pulse wave tonometry is a non-invasive technique performed using a hand-held tonometer that generates two indices which correspond to large artery elasticity (lae) and small artery elasticity (sae). lae and sae estimates by pulse waveform analysis have previously shown greater correlation to framingham risk when directly compared with other techniques such as flow-mediated diltation, and both lae and sae are associated with traditional cardiovascular risk factors (smoking, insulin resistance, hypertension). it is unclear what the net effect of maraviroc, a chemokine-receptor blocker is on cardiovascular function. the aims of this substudy are: * to compare changes in the vascular endothelium between the control arm ((n(t)rti) plus pi/r) and each of the maraviroc switch arms over 48 weeks of follow-up. * to compare the changes in biomarkers and selected immunological markers between the control arm ((n(t)rti) plus pi/r) and each of the maraviroc switch arms over 48 weeks of follow-up.

Eligibility criteria:
inclusion criteria: * enrolled prior to treatment in the parent study; * provision of written, informed consent for participation in the substudy exclusion criteria: * known supraventricular tachycardia such as atrial flutter and/or fibrillation that precludes the measurement of pulse wave using tonometry.

Keywords: cardiovascular function maraviroc
omega 3 polyunsaturated fatty acids (pufa) or magnesium in obese polycystic ovary syndrome patients

Conditions: Polycystic Ovary Syndrome; Obesity

Summary: polycystic ovary syndrome (pcos) is the most prevalent endocrine disorder in reproductive age women. pcos is usually characterized by an excessive androgen production, menstrual irregularities, and polycystic ovaries. women with pcos are often obese and have a varying degree of insulin resistance (ir). weight reduction constitutes the initial treatment for these patients. metformin has proven to be useful in ir and is frequently used in pcos. however metformin use may be accompanied by gastrointestinal discomfort, and a high abandon rate. other therapeutic alternatives such as magnesium and polyunsaturated fatty acids have been used in other ir states and may be useful in pcos. the aim of this study is to asses the efficacy of these alternatives in obese pcos patients.

polycystic ovary syndrome (pcos)

Eligibility criteria:
inclusion criteria: * polycystic ovary syndrome according to rotterdam criteria, * bmi ≥ 27 kg/m2 exclusion criteria: * type 2 diabetes mellitus, * in treatment for polycystic ovary syndrome features

Keywords: polycystic ovary syndrome obesity metformin magnesium polyunsaturated fatty acids
new surgical approach in labioplasty

Conditions: Gynecologic Disease; Surgery-Complications

Summary: the data of patients who underwent labiaplasty + vaginoplasty between 2020 and 2022 by a single surgeon in our clinic were analyzed. preoperative and postoperative fsfi (female sexual function index) questionnaire scores were used to compare the results of the classical surgical approach and the new surgical approach technique designed according to the fibonacci ratio in the early postoperative period such as operating time, bleeding amount, etc.

the data of patients who underwent labiaplasty + vaginoplasty between 2020-2022 for reasons such as vaginal laxity, personal hygiene problems, recurrent vaginal infections were analyzed retrospectively. the data of the patients who underwent fibonacci ratio, which is a new surgical approach technique( by okuyan e. m.d), and the patients who underwent classical surgical technique were taken from their files and retrospectively analyzed. data including age, body mass index, number of live births, preoperative fsfi, fgsis and postoperative one month fsfi (female sexual function index) and fgsis (the female genital self-image scale) scores were recorded and compared between both groups.

Eligibility criteria:
inclusion criteria: 1. no history of any disease 2. the presence of at least 2 of the reasons such as dislike of cosmetic appearance, vaginal abundance, personal hygiene disorder, difficulty in wearing underwear. 3. body mass index between 15-25 4. informed consent has been obtained for the new surgical approach technique. 5. not taking any medication continuously 6. willing to participate in the study. exclusion criteria: 1. absence of at least 2 of the reasons such as dislike of cosmetic appearance, vaginal abundance, personal hygiene disorder, difficulty in wearing underwear. 2. history of continuous medication, alcohol and/or smoking. 3. history of chronic diseases (asthma, diabetes mellitus, cardiac disease, psychiatric disease etc.) 4. body mass index outside the range of 15-25. 5. not wanting to be included in the study or wanting to leave the study after inclusion.

Keywords: labioplasty vaginoplasty fibonacci ratio