Kornimate/medical-research-clean huggingface dataset:
a comprehensive third-generation intervention for people with psychosis and post-traumatic stress symptoms

Conditions: Trauma, Psychological; Psychosis

Summary: existing data suggest that both trauma and post-traumatic stress disorder (ptsd) are very common among individuals with psychosis. the presence of ptsd symptoms in psychosis is associated with worse clinical outcomes and poorer social functioning. however, ptsd is a poorly attended and poorly studied condition among this population. research to date indicates that trauma-focused treatments are safe and effective for ptsd, even when psychotic comorbidity is present. recent systematic reviews of psychological interventions for trauma in psychosis found that are effective in reducing trauma symptoms, suggesting that they should be implemented in front-line services. nonetheless, larger confirmative trials are required to form robust conclusions.the aim of this project is to examine the efficacy of comprehensive third-generation protocol for people with comorbid trauma and psychosis.

this study is a randomized clinical trial at psychiatric rehabilitation services of the public network of care for people with serious mental disorders. we hypothesize that participants receiving the intervention, in comparison with controls, will show a reduction in general, ptsd and psychotic symptomatology, an improvement in levels of functioning and well-being, a greater ability to regulate emotions with more help-seeking behaviours. given the complexity of both psychosis and ptsd and the reluctance of professionals to treat it, we plan to develop a precise comprehensive protocol. in order to address all issues associated with both psychosis and comorbid ptsd, the protocol will be developed following the three stages of recovery from trauma: first, focusing on establishing the therapeutic alliance and safety; second, focusing on recounting and re-processing the traumatic event; and third, focusing on reconnecting with others and with life despite the trauma experienced. the therapy will be adapted to the characteristics of people with smd and administered in 11 90-minute individual sessions per week, combining strategically act, mindfulness, emdr as well as positive psychology interventions.

Eligibility criteria:
inclusion criteria: those showing a high risk of ptsd (tsq ≥6) will be further evaluated to determine whether they meet the inclusion criteria. participants must: * be between the ages of 18 and 65 fluent enough in spanish language; * meet the criteria for a diagnosis of a psychotic spectrum disorder or a mood disorder with psychotic symptoms according to mini (sheeman et al., 1997); * meet ptsd diagnostic criteria according to the clinician-administered ptsd scale (caps; blake et al., 1995) exclusion criteria: * those who have a diagnosis of substance or alcohol abuse or dependence in the 30 days prior to participation in the study * to have a severe neurocognitive problems or brain damage that interfere with the basic processing of information in psychotherapy.

Keywords: psychosis trauma psychological intervention emdr
dried blood spots for sars-cov-2 serology (covid-19).

Conditions: SARS-CoV-2 Acute Respiratory Disease

Summary: this study aims to validate dried blood spots (dbs) for sars-cov-2 (severe acute respiratory syndrome 2) antibody detection in elderly individuals.

in the current sars-cov-2 pandemic, testing for sars-cov-2 specific antibodies is paramount to monitor immune responses in post-authorization vaccination and sero-epidemiology studies. however, large scale and iterative serological testing by venipuncture in older persons can be challenging. capillary blood sampled using a finger prick and collected on protein saver cards, i.e., dried blood spots (dbs), has already proven to be a promising alternative. however, elderly persons have a reduced cutaneous microvasculature, which may affect dbs-based antibody testing. therefore, we aimed to evaluate the performance of dbs for the detection of sars-cov-2 antibodies in nursing homes residents. we collected venous blood and paired whatman and euroimmun dbs from nursing home residents, and from staff as a reference population. venous blood samples were analyzed for the presence of sars-cov-2 igg antibodies using the abbot chemiluminescent microparticle immunoassay (cmia). dbs were analyzed by the euroimmun enzyme-linked immuno sorbent assay (elisa) for sars-cov-2 igg antibodies.

Eligibility criteria:
inclusion criteria: * nursing home staff and residents exclusion criteria: * not applicable

Keywords: serology dried blood spot elderly nursing home residents covid-19 antibodies immunoglobins serosurveillance vaccination enzyme-linked immunosorbent assay (elisa)
pelvic floor muscle training in the treatment of erectile dysfunction

Conditions: Erectile Dysfunction

Summary: erectile dysfunction affects about 40% of all men above the age of 40 and the prevalence increases with increasing age. it is not possible to cure the condition as current forms of treatment are aimed solely at improving symptoms. treatment options today include medications, injection therapy, and vacuum pumps, among others. however, pelvic floor muscle training is a natural, inexpensive, and non-invasive form of treatment that is used to a limited extent. theoretically, a strengthening of the pelvic floor muscles can help increase the intracavernous pressure and thereby the hardness of the erection. furthermore, tense pelvic floor muscles can help compress pelvic veins and reduce blood flow away from the penis which prolongs the erection. finally, it is possible that pelvic floor muscle training can contribute to an increased blood supply to the pelvic floor and the penis which will have positive effects in relation to both the integrity of the penile tissue and the physiological erection mechanism itself. this study aims to investigate the effect of pelvic floor muscle training in men with erectile dysfunction. the study hypothesis is that pelvic floor training can provide a clinically significant improvement in the erection function at individual patient level


Eligibility criteria:
inclusion criteria: * erectile dysfunction for more than 6 months * iief-ef score \< 25 * in a stable heterosexual relationship in minimum of 3 months (since all questionnaires are only validated for heterosexuals) exclusion criteria: * known psychiatric, neurological, and/or endocrine disorders (including hypogonadism with total testosterone \<12 nmol / l) * traumatic nerve damage * diabetes * previous surgery or radiotherapy in the pelvic region * nerve disorders that prevent nerve connection to the pelvic floor muscles * severe heart disease in the form of unstable angina, nyha class \> ii heart failure, uncontrolled arrhythmia or severe symptomatic and/or severe valvular disease * use of anti-androgen drugs peyronie's disease and/or previous cases of priapism * alcohol overconsumption (more than 21 items per week)

Keywords: pelvic floor muscle erectile dysfunction sexual dysfunction impotence kegel exercise training
a study of pexidartinib in tenosynovial giant cell tumor in japan

Conditions: Tenosynovial Giant Cell Tumor

Summary: this phase 2, multicenter, two-part, open-label, single-arm study will be conducted in japan and will evaluate the safety, tolerability, pharmacokinetics (pk), and efficacy of pexidartinib in adult participants with symptomatic tenosynovial giant cell tumor (tgct) associated with severe morbidity or functional limitation and not amenable to improvement with surgery.

this study will consist of 2 parts. in part 1, pexidartinib 800 mg/day (400 mg twice a day \[bid\]) will be administered on an empty stomach and tolerability and pk of pexidartinib will be evaluated to determine the initiation of part 2. in part 2, pexidartinib 800 mg/day (400 mg bid) will be administered on an empty stomach and efficacy, safety, and pk of pexidartinib will be evaluated.

Eligibility criteria:
inclusion criteria: * age ≥20 years * a diagnosis of tgct (i) that has been histologically confirmed by a pathologist1 and (ii) associated with severe morbidity or functional limitations and not amenable to improvement with surgery determined consensually by qualified personnel (eg, 2 surgeons or a multi-disciplinary tumor board). * measurable disease as defined by recist version 1.1 (except that a minimal size of 2 cm is required), assessed from mri scan by a central radiologist. exclusion criteria: * known metastatic tgct. * pre-existing increased serum transaminases; total bilirubin or direct bilirubin (\>upper limit of normal); or active liver or biliary tract disease, including increased alkaline phosphatase. * significant concomitant arthropathy in the affected joint, serious illness, uncontrolled infection, or a medical or psychiatric history that, in the investigator's opinion, would likely interfere with a participant's study participation or the interpretation of his or her results. * use of strong cytochrome p450 3a inducers, including st john's wort, proton pump inhibitors and potassium-competitive acid blockers, or other products known to cause hepatotoxicity.

Keywords: tenosynovial giant cell tumor tgct giant cell tumor of tendon sheath gctts pigmented villonodular synovitis pvns
safety and efficacy of doxycycline in patients with non-ischemic cardiomyopathy

Conditions: Non-ischemic Cardiomyopathy; Systolic Heart Failure (NYHA II-III)

Summary: non-ischemic cardiomyopathy and heart failure are highly influenced by the presence of systemic inflammation. doxycycline is a fda-approved drug to treat bacterial infections which also shows powerful anti-inflammatory effects. in this study we plan to determine the effects of doxycycline in patients with stable heart failure and non-ischemic cardiomyopathy on peak of aerobic exercise capacity (peak v02) and ventilator efficiency measured with a cardiopulmonary test.

in this study of safety and efficacy of doxycycline in patients with non-ischemic cardiomyopathy population, we will enroll 24 patients with a clinical diagnosis of heart failure and non-ischemic cardiomyopathy (recent imaging study documenting lv ejection fraction \<50%, and no history of coronary or ischemic heart disease) in a single-center, randomized, double-blinded, placebo-controlled clinical trial with allocation 1:1:1 to doxycycline 100 mg twice daily or doxycycline 20 mg twice daily or placebo for 2 weeks.

Eligibility criteria:
inclusion criteria: * non-ischemic cardiomyopathy (lvef\<40%) * heart failure nyha ii-iii exclusion criteria: * age \<18 * recent changes (previous 3 months) in hf maintenance medications (beta-blockers, angiotensin converting enzyme \[ace\] inhibitors, aldosterone antagonists, vasodilators, cardiac glycosides, diuretics) * hospitalization for worsening hf or acute decompensated hf within the previous 12 months * history of coronary or ischemic heart disease * anticipated need for cardiac resynchronization therapy (crt) or automated-implantable cardioverter defibrillator (aicd) or coronary revascularization or cardiac surgery * angina or electrocardiograph (ecg) changes that limit maximum exertion during cardiopulmonary exercise testing * active infection including chronic infection * active cancer (or prior diagnosis of cancer within the past 10 years) * recent (\<14 days) use of anti-inflammatory drugs (not including nsaids), chronic inflammatory disorder (including but not limited to rheumatoid arthritis, systemic lupus erythematosus), malignancy, or any comorbidity limiting survival or ability to complete the study * pregnancy * inability to give informed consent * other conditions limiting completion of cardiopulmonary exercise test or completion of the study

Keywords: heart failure non-ischemic cardiomyopathy
pharmacokinetic evaluation of moxifloxacin administered intravenously and orally in healthy volunteers who have had a gastric bypass

Conditions: Gastric Bypass; Body Weight

Summary: roux-and-y gastric bypass is one of the most common forms of bariatric surgery; due to a reduction in size of the stomach and intestine, the available surface area for the absorption of oral drugs is strongly decreased. this may lead to a reduced bioavailability resulting in a reduced efficacy of the drug. however, in literature there is no information available about the impact of bariatric surgery on the pharmacokinetics of moxifloxacin. this protocol evaluates the moxifloxacin plasma levels, the variability between subjects and the absolute bioavailability, after oral administration of 400 mg moxifloxacin in healthy volunteers who have had a gastric bypass at least 6 months ago and who now have a stable body weight.


Eligibility criteria:
inclusion criteria: * healthy volunteers who have had a gastric bypass at least 6 months ago and whose body weight has not changed more than 5% during the last 3 months * age between 18 and 60 years old * able to give informed consent exclusion criteria: * other forms of bariatric surgery (scopinaro and mason/sleeve) before gastric bypass surgery * hypersensitivity to moxifloxacin, other quinolones or to any of the excipients * pregnancy and lactation * creatinine clearance \< 80 ml/min * transaminases \> 2x the upper limit of normal (ast/alt) * impaired liver function (child pugh c) * fasting glycaemia \> 125mg/dl * epilepsy * patients with a history of tendon disease/disorder (especially achilles tendon rupture) related to quinolone treatment * patients with the following heart disorders: * electrolyte disturbance, particularly an uncorrected hypokalaemia * clinically relevant bradycardia * clinically relevant heart failure with reduced left-ventricular ejection fraction * previous history of symptomatic arrhythmias * congenital or documented acquired qt prolongation or concurrently use of drugs that prolong the qt interval: * anti-arrhythmics (classes ia and iii) * neuroleptics * tricyclic antidepressants * antimicrobials (e.g. sparfloxacin, intravenous erythromycin, pentamidine, antimalarials particularly halofantrine) * some antihistamines (e.g. terfenadine, astemizole, mizolastine) * cisapride, intravenous vincamine, bepridil and diphemanil * no normal thyroid function * all clinically significant disorders that can interfere with the study

Keywords: roux-and-y gastric bypass surgery stable body weight
study of docetaxel and cisplatin combined with nimotuzumab as first-line treatment in patients with recurrent or metastatic nasopharyngeal carcinoma

Conditions: Nasopharyngeal Carcinoma

Summary: the purpose of this single arm,phase ⅱ clinical trail is to determine the safety and efficacy of docetaxel and cisplatin combined with nimotuzumab in the treatment of recurrent and metastatic nasopharyngeal carcinoma


Eligibility criteria:
inclusion criteria: * biopsy proved nasopharyngeal carcinoma; * stage ivb according to the eighth edition american joint committee on cancer/union for international cancer control staging system, or recurrent disease beyond more than 6 months after curative chemotherapy and/or radiotherapy; * 18-70 years; * without other malignancy; * had at least one measurable disease; * had an eastern cooperative oncology group (ecog) performance status of 0-2; * estimated life expectancy exceeding 3 months; * adequate functions of the major organs. exclusion criteria: * allergic to docetaxel or cisplatin or nimotuzumab; * pregnant or lactating female; * patients received other clinical trails within 3 months; * had serious infections, comorbidities or vital organs dysfunction.
study of the effect of systematic screening of residents and caregivers with covid-19 by nasopharyngeal swab (rt-pcr)

Conditions: COVID-19

Summary: the current covid-19 epidemic has overwhelmed the health systems of many countries in which it has broken out, forcing various governments to institute population containment measures. residents of medico-social institutions for the elderly are particularly at risk of developing severe forms because they have a large number of factors favoring the progression to a severe form (very advanced age, multiple comorbidities, dependence in activities of dayli life). the specificity and positive predictive value of clinical signs are not very important in this population; which makes the diagnosis even more complicated. one of the strategies to try to protect these residents, in addition to room containment and clinical surveillance, would be to carry out a systematic screening campaign of all residents and all caregivers, then to consider reorganizing the establishments with a sector "covid +". this was announced by the french minister of health olivier veran on 04/06/2020 from the first confirmed case of covid-19 in an institution. however, asymptomatic subjects may have a "negative" rt-pcr test at one point but which is positive in the following days. and in this interval they would still be contagious. it is therefore not excluded that the implementation of such a screening campaign will not be effective in reducing the number of new cases of covid-19 in medico-social institutions for the elderly


Eligibility criteria:
inclusion criteria: * major subject (≥18 years old) * subject hospitalized in a medico-social institution for the elderly (smti or ehpad) at the hus or in another center which will be recruited secondarily and whose patients in a unit all have the same attending physician. * subject (or family) who did not express their disagreement with the reuse of this data for the purposes of this research. exclusion criteria: * subject having expressed opposition to participating in the study * subject under guardianship or guardianship * subject under safeguard of justice

Keywords: covid-19 rt-pcr sars-cov-2
percutaneous cholangiopancreatoscopy registry

Conditions: Biliary Stones; Cholangiocarcinoma, Intrahepatic; Biliary Stricture; Cholelithiasis; Choledocholithiasis

Summary: the percutaneous cholangiopancreatoscopy (pcps) registry is an observational, multicentric, prospective, and retrospective registry of patients undergoing the percutaneous cholangiopancreatoscopy procedure at sites across the united states. in the retrospective component of the study, clinical and procedural data regarding patients who have undergone clinical indicated percutaneous cholangiopancreatoscopy procedure in the past will be collected from all the registry sites and stored in a secure database. the prospective component of the registry will run for three years at each site where patients undergoing the clinically indicated percutaneous cholangiopancreatoscopy procedure will be enrolled in the study, and the patients' data will be collected whenever the patients present to interventional radiology (ir) for a procedure or clinic visit.


Eligibility criteria:
inclusion criteria: * male or female adults * 18 years of age and older * patients undergoing clinically indicated percutaneous cholangiopancreatoscopy procedure at the johns hopkins hospital or one of the registry sites. * willing and able to understand and sign a written informed consent document for the prospective component of the study. exclusion criteria: * pregnant women * children (\< 18 years of age)
the dynamics of human atrial fibrillation

Conditions: Atrial Fibrillation; Atrial Tachyarrhythmia

Summary: the study is conducted in patients with atrial fibrillation undergoing clinically prescribed ablation. the study hypothesis is that ablation at specific sites that are identified to 'drive' the atrial fibrillation may improve the success of the ablation procedure.


Eligibility criteria:
inclusion criteria: * subjects will be patients undergoing electrophysiology study and ablation for paroxysmal or persistent atrial fibrillation (af) after having failed \>or= 1 anti-arrhythmic drug.

Keywords: atrial fibrillation ablation
a randomized control trial of a simulation-based curriculum to enhance skills in colonoscopy

Conditions: Colorectal Cancer

Summary: colonoscopy is a commonly used medical procedure. medical and surgical residents learning colonoscopy typically learn the procedure experientially but simulation based teaching is increasingly being integrated into training programs. the optimal manner to teach colonoscopy on virtual-reality simulators is uncertain. we aim to test a curriculum in simulation-based colonoscopy with self-directed learning on simulators.


Eligibility criteria:
inclusion criteria: * trainee endoscopists from the gastroenterology and general surgery programs at the university of toronto exclusion criteria: * greater than 20 colonoscopies performed
a video decision support tool to assist elderly patients in esrd treatment decision-making

Conditions: Chronic Kidney Disease; Decision-making

Summary: in the united states, it is estimated that there are approximately 630,000 patients who have esrd with two-thirds of those patients subsequently receiving maintenance dialysis. studies have demonstrated that the initiation and timing of dialysis for those with esrd seem to vary widely regionally - confirming the uncertainty of the benefits of chronic dialysis in this population pre-dialysis education programs inform patients of all of their options allowing them to choose renal replacement therapy that is most consistent with their wishes. recent evidence has supported using different methods of delivering education including videos to complement standard clinical care practices to promote informed decision making. this proposed study will serve to examine the efficacy of a dialysis modality video decision support tool to inform chronic kidney disease patients of different dialytic and non-dialytic therapies.


Eligibility criteria:
inclusion criteria: * english-speaking during clinical encounters * stage 4 or 5 ckd (defined by the chronic kidney disease epidemiology collaboration for estimation of gfr \< 30 ml/min/1.73m2) exclusion criteria: * known history of dementia * legally blind * listed for kidney transplant
testing alert with gto in middle schools

Conditions: Substance Abuse

Summary: to test the efficacy of project alert with the support enhancement tool, getting to outcomes.

this study combines two programs that have been developed by rand researchers: project alert (pa) and getting to outcomes (gto). project alert is a widely used drug prevention program for middle school youth. though it has an evidence-base for effectiveness, the program (like most evidence-based programs in schools) is not run with adequate fidelity representing a large gap between what is developed and tested for effectiveness and what is used in actual practice. thus, the study will conduct an updated randomized controlled trial of pa and test gto as a tool to increase adoption and adequate fidelity of the program in schools. gto's previous evidence suggests it could be effective in public schools, yet this remains an empirical question. a successful demonstration of pa and gto could fundamentally transform evidence-based prevention's delivery, reach, and thus impact, in the us.

Eligibility criteria:
inclusion criteria: * eligibility for student participants: all students in 7th grade, primarily aged 12-14, attending school at one of the enrolled schools in the study. * eligibility for school staff participants: all educators interested in enrolling in the study at each of the enrolled schools. exclusion criteria: * not meeting eligibility criteria note: the age range is from 11 to 70 to account for both the student and teacher populations.