Kornimate/medical-research-clean huggingface dataset:
relationship between biological profiles and clinical evolutions within the same cluster covid-19 (covidcollect)

Conditions: Covid19; Contact Case

Summary: the hypothesis is that from a cluster defined by a confirmed positive case of covid-19 and its contact cases, it is possible to study the different expressions and clinical evolutions of covid-19 infection and to explore the biological profiles related to the observed clinical history. certain biological determinants (virological, immunological, microbological or gentic) could indeed be correlated with the clinical presentation and/or be useful for personalized care. the main objective is to study the relationship between the biological profiles observed and the clinical evolutions within the same cluster of transmission of the coronavirus sars-cov-2 (positive covid-19 cases and contact subjects).

subjects with a covid-19 infection and thei contact cases (identification according to health insurance criteria, see "améli.fr") will be offered a clinical evaluation and the takin of biological samples, whether they are hospitalized or via the outpatient screening channel. for the main objective: during the d0 visit, the subjects who agreed to participate in the study will have a clinical evaluation according to a standardized questionnaire and a nasopharyngeal swab, saliva, blood, stool and urine. for secondary objectives : longitudinal follow-up will be carried out for 21 days, for index cases and contact cases, whether they have a positive or negative rt-pcr test on d0. a final consultation will be carried out at m3. nasopharyngeal samples, saliva, blood, stool and urine will be taken on d10 and d21. a blood test will be taken at m3 to carry out a covid-19 serology.

Eligibility criteria:
inclusion criteria: * child or adult, no age limit * able to give informed consent to participate in research * if a minor participant: consent of the legal representatives * if confirmed case covid-19 (symptomatic or asymptomatic): laboratory result confirming infection with sars-cov-2 by rt-pcr or by serology * if contact case: people identified as a risk contact according to the criteria of the "amélie.fr" health insurance exclusion criteria: * subjects under tutorship, curatorship, deprived of liberty, safeguard of justice * refusal of the child * refusal of participation

Keywords: sars-cov-2 covid19 confirmed case biological collection contact case cluster
tacrolimus versus methotrexate as rescue therapy for refractory inflammatory bowel disease

Conditions: Inflammatory Bowel Diseases

Summary: mesalazine, steroid, immunosuppressants and biologic agents are main medical treatments in treating inflammatory bowel diseases. yet some patients develop severe side effects or initial invalid to conventional therapies. some studies have already showed that tarcolimus and methotrexate are both effective in inducing and maintaining disease remission. here we conduct a retrospective study to compare the efficancy of tarcolimus and methotrexate in treating refractory inflammatory bowel diseases as rescue therapy.


Eligibility criteria:
inclusion criteria: * tarcolimus or methotrexate was used in refractory inflammatory bowel disease patents exclusion criteria: * pregnant woman
antimicrobial hernia repair device

Conditions: Ventral Hernias; Incisional Hernias

Summary: this prospective early feasibility clinical study will collect information regarding the safety and efficacy of the cook® antimicrobial hernia repair device to reinforce soft tissue during ventral or incisional hernia repair in clean-contaminated and contaminated (i.e., class ii and class iii) surgical fields.


Eligibility criteria:
inclusion criteria: * patient with ventral or incisional hernia that is to be surgically corrected in a class ii and class iii surgical field. exclusion criteria: * less than 21 years old * unwilling or unable to sign and date the informed consent * pregnant, breastfeeding, or planning to become pregnant prior to completing the study * unable or unwilling to comply with follow-up schedule * simultaneously participating in another investigational drug or device study. * medical condition or disorder that would limit life expectancy to less than the primary clinical study endpoint.
impact of family history and decision support on high-risk cancer screening

Conditions: Colorectal Cancer

Summary: family health history can help identify patients at higher than average risk for disease. there is no standardized system for collecting and updating family health history, using this information to determine a patient's disease risk level, and providing screening recommendations to patients and providers. patients will enter their family health history into metree, a family history software program. the program will produce screening recommendations tailored to the patient's family health history. the investigators will examine whether this process increases physician referrals for, and patient uptake of, guideline-recommended screening for colorectal cancer.

eligible patients are aged 40-65 years, enrolled in primary care, do not have a personal history of colorectal cancer, and have some knowledge of family health history. in aim 1, a retrospective chart review will be conducted to determine the baseline rate of documenting family health history of colorectal cancer in the medical record for patients enrolled in the aim 2 randomized trial. in aim 2, consented patients will be randomized to provide patient-entered family health history and receive patient and provider decision support at enrollment or 12 months later (wait-list control). the primary outcome is risk-appropriate crc screening/surveillance referral for patients 12 months post-enrollment. secondary outcomes include patient uptake of recommendations and referral for genetic consultation 12 months post-enrollment. in aim 3, qualitative interviews will be conducted with physicians and clinic leaders; data will be analyzed using conventional content analysis. in aim 4, data will be obtained from the administrative databases and patient medical records to conduct a budget impact analysis.

Eligibility criteria:
inclusion criteria: primary care provider inclusion criteria: * primary care physician, * physician assistant, or nurse practitioner; * at least one half-day of primary care clinic per week. patient inclusion criteria: * assigned to an enrolled pcp; * english as preferred language; * no plans to relocate or leave the va system in the next 12 months; * at least one primary care appointment in the 18 months prior to enrollment; * upcoming pcp appointment with assigned pcp; * aged 40-64 years; no previous history of colorectal cancer or adenomatous polyps or inflammatory bowel disease; * no endoscopy within previous 3 years; some knowledge of family health history exclusion criteria: n/a (contained within inclusion criteria)

Keywords: colorectal cancer early detection of cancer
cytosorb treatment of critically ill patients registry

Conditions: Septic Shock; Acute Respiratory Distress Syndrome; Trauma; Rhabdomyolysis; Cardiogenic Shock; Pancreatitis; Acute on Chronic Liver Failure; Acute Liver Failure; Burns; Chimeric Antigen Receptor T-Cell Therapy (CAR-T) Cytokine Release Syndrome (CRS); Extracorporeal Life Support; Postoperative Endocarditis; Hemophagocytic Lymphohistiocytoses; Liver Transplant; Complications; Infectious Disease; Postoperative Vasoplegic Syndrome; Drug Overdose; Sepsis

Summary: registry intended to provide a data repository and reporting infrastructure for the surveillance of cytosorb device use in real-world critical care settings, and to serve as an objective, comprehensive, and scientifically-based resource to measure and improve the quality of patient care


Eligibility criteria:
inclusion criteria: 1. planned or actual cytosorb® 300 ml device utilization 2. informed consent for prospective registry participation exclusion criteria: 1. use of the cytosorb® 300 ml device for antithrombotic removal only 2. intraoperative use of cytosorb® 300 ml device during cardiac surgery only 3. the occurrence of a complication or other medically justified circumstance that arises after written informed consent has been obtained from the patient and before or during the planned therapy and as a result of which the use of cytosorb® 300 ml adsorber is contraindicated or no longer appropriate.
mental practice on balance

Conditions: Movement, Involuntary

Summary: the main objective of this research is to see the effect of two mental practice techniques on static and dynamic balance.


Eligibility criteria:
inclusion criteria: * age between 18 and 60 * healthy and with no pain subjects exclusion criteria: * any cognitive impairment that hindered viewing of audiovisual material. * difficulty understanding or communicating. * presence of systemic pathology, central nervous system or rheumatic disease. * inadequate understanding of the spanish language to follow instructions for measuring and treatment. * collaboration of pregnant women. * underage subjects * subjects with pain at the time of the study.

Keywords: motor imagery
a trial of prednisolone in combination with spi-62 in participants with polymyalgia rheumatica (pmr)

Conditions: Polymyalgia Rheumatica

Summary: this will be an open label phase 1b trial to characterize the pharmacodynamics and pk of prednisolone and spi-62 when co-administered to participants with pmr. up to 24 participants could be recruited.

this will be an open label phase 1b trial to characterize the pharmacodynamics and pk of prednisolone and spi-62 when co-administered to participants with pmr. up to 24 participants could be recruited. patients diagnosed with pmr whose pmr symptoms do not vary in intensity or frequency to the degree that a clinically indicated increase in prednisolone prescription might be anticipated will be included in the trial. participants will continue to receive prednisolone and will receive spi-62 from days 3-16 inflammatory biomarkers, symptom measures, biomarkers of prednisolone toxicity, pk of prednisolone and spi-62, and biomarkers of spi-62 pharmacological activity will be measured on days 2, 3, and 16. abpm will be monitored on days 1 and 15.

Eligibility criteria:
inclusion criteria: * written informed consent * diagnosis of pmr according to european league against rheumatism and american college of rheumatology classification criteria confirmed by a rheumatologist * absence of pmr relapse based on symptoms and acute phase markers * daily oral prednisolone 10, 12.5, 15, 17.5, or 20 mg dose that will have been stable for at least 7 days prior to day 1 exclusion criteria: * any contraindication for prednisolone administration * a diagnosis or any clinical features of giant cell arteritis * any autoimmune disease (e.g., late-onset rheumatoid arthritis) other than pmr * use of medications for treatment of pmr other than oral prednisolone within specified intervals prior to day 1 and during the treatment period * use of other medications likely to interfere with trial assessments * history or diagnosis of endogenous hypercortisolism * any current or prior medical condition, medical or surgical therapies, or clinical trial participation expected to interfere with the conduct of the trial or the evaluation of its results
pharmacokinetic comparisons of two donepezil formulations

Conditions: Alzheimer Disease

Summary: to compare the relative bioavailability and pharmacokinetic characteristics of a newly developed donepezil formulation with a conventional formulation in healthy subjects with a single dose, randomized, open-label, 2-sequence -2period crossover study.

this single dose, open label, balanced, randomized, two-treatment, two-period, two-sequence, crossover study was conducted to compare the relative bioavailability and pharmacokinetic characteristics of a newly developed formulation with a conventional formulation in healthy subjects. for this, a single-center, randomized, single-dose, open-label, 2-way crossover study with a 21-day washout period was conducted in 22 healthy volunteers. plasma samples for the analysis of donepezil were collected up to 240 h after drug administration. participants received either reference or test drug formulation of 10 mg donepezil in the first period and the alternative formulation in the second period. plasma concentrations of donepezil were determined by validated high-performance liquid chromatography coupled to tandem mass spectrometry detection. pharmacokinetic parameters, including cmax and auc, were determined by noncompartmental analysis. analysis of variance (anova) was carried out using log-transformed cmax and auc, and the mean ratios and their 90% confidence intervals (ci) were calculated. according to regulatory requirements set forth by korea and the us food and drug administration, products meet the criteria for bioequivalence if the 90% cis of the mean ratios for cmax and auc are within the range of 0.80 to 1.25.

Eligibility criteria:
inclusion criteria: * males age 20 to 45 years * body weight \> 45 kg with +/- 20% of ideal body weight * signed and dated informed consent form which meets all criteria of current fda and kfda regulations exclusion criteria: * subjects with acute conditions. * presence of history affecting adme * clinically significant history or current evidence of a hepatic, renal, gastrointestinal, or hematologic abnormality * hepatitis b, hepatitis c, or hiv infection revealed on the laboratory findings * any other acute or chronic disease * a history of hypersensitivity to donepezil * a history of alcohol or drug abuse * participation in another clinical trial within 3 months * smoked \>10 cigarettes daily * consumption over 5 glasses daily of beverages containing xanthine derivatives * use of any medication having the potential to affect the study results within 10 days before the start of the study.

Keywords: pharmacokinetics bioequivalence donepezil
sensory training to treat focal dystonia

Conditions: Dystonic Disorder

Summary: this study will examine the effectiveness of braille reading as a sensory training program for improving symptoms of focal (localized) dystonia, a movement disorder caused by sustained muscle contractions. musicians, writers, typists, athletes and others whose work involves frequent repetitive movements may develop focal dystonia of the hand. dystonia patients have an impaired sense of touch, and it is thought that symptoms may improve with sensory tactile (touch) training. patients with task-specific dystonia and healthy normal volunteers may be eligible for this 8-week study. patients will undergo evaluation of their dystonia and a complete neurologic examination. healthy volunteers will have a complete physical examination. on the first day of the study, after 4 weeks and after 8 weeks, all participants will have a gap detection test for sensory perception testing. the test uses eight plastic devices called jvp-domes with ridges of different widths on the surface. the subject's arm and hand are held in palm-up position and the right index finger is tested for about 1 second 20 times with each dome. the subject is asked to report whether the direction of the dome is vertical or horizontal. the test takes about 30 minutes. patients with dystonia will also have a their symptoms evaluated at these visits. the evaluation involves completing a written questionnaire and writing a paragraph. all participants will be trained in braille reading at nih. sessions will be given every day the first week, twice a week the second and third weeks, and once a week the following weeks.

it has been hypothesized that dystonia may be a sensory disorder. animal studies as well as physiological studies of patients with focal dystonia have demonstrated sensory dysfunction. it has also been shown that patients with dystonia have impaired sensory perception including when assessed with the jvp gap detection test. this could possibly result from enlargement and dedifferentiation of representations in the sensory cortex. we therefore hypothesize that sensory training could improve the impaired sensory perception and hence improve the dystonia. this study will examine if braille reading as a sensory training program can correct the sensory perception and the dystonia. the primary outcome is improvement in the jvp gap detection test.

Eligibility criteria:
patients with idiopathic task specific dystonia and healthy normal volunteers. patients must not be receiving botulinum-toxin treatment or other medications for the past three months prior to entering the study. patients must be able to keep their hand in a pronated 'reading' position for one hour.

Keywords: gap detection test fahn-scale visual analog and verbal scale writing standard paragraph braille reading grade i
the role of mirna in group 3 pulmonary hypertension

Conditions: Pulmonary Hypertension

Summary: this study recognizes the substantial value of lung tissue obtained from explanted lungs for fundamental research purposes.by analyzing pulmonary tissue affected by pulmonary hypertension, it is possible to discover shared pathogenetic mechanisms between these two groups and to gain a deeper understanding of the mechanisms underlying pulmonary hypertension.

lung transplantation serves as the sole therapeutic approach targeting the enhancement of life expectancy and quality of life for individuals afflicted with advanced parenchymal or vascular lung diseases. the current study aligns with this objective, recognizing the substantial value of lung tissue obtained from explanted lungs for fundamental research purposes. by investigating lung tissue affected by both group 3 and group 1 pulmonary hypertension, it becomes possible to uncover shared pathogenic mechanisms between these two groups and gain a more profound understanding of the underlying mechanisms driving group 3 pulmonary hypertension. furthermore, delving into the cells responsible for the expression of dysregulated mirnas offers the potential to identify novel target mechanisms for the clinical management of group 3 pulmonary hypertension, an area currently limited in therapeutic options. through a comparative analysis of the quantitative expression patterns of each mirna among distinct groups, it becomes feasible to determine the extent of involvement of specific pathogenic pathways in the various forms of pulmonary hypertension. consequently, this approach provides guidance for future research, directing focus towards the most relevant mechanisms of interest.

Eligibility criteria:
inclusion criteria * patients who underwent lung transplantation at the aou irccs policlinico sant'orsola in bologna and the irccs fondazione policlinico san matteo in pavia (satellite center) from january 1, 2010, to december 31, 2021. * diagnosis of idiopathic pulmonary arterial hypertension, idiopathic pulmonary fibrosis, or chronic obstructive pulmonary disease. * patients who underwent at least one pre-transplant right heart catheterization in clinically stable conditions, with findings of mpap ≥ 25 mmhg, pvr \> 3 wu, and pcp \< 15 mmhg. * suitability of lung explant tissue available in the archives of the participating pathology departments: presence of at least 3 pulmonary arterioles in each specimen. * acquisition of informed consent. exclusion criteria * unsuitability of lung tissue for molecular biology investigations (due to preservation issues or deterioration of the necessary arteriolar structures). * patients with active neoplastic diseases.
haemochromatosis:phlebotomy versus erythrocytapheresis therapy

Conditions: Hemochromatosis

Summary: in this project we plan to evaluate the effectiveness of erythrocytapheresis against phlebotomy, both regarding the impact on the reduction in iron overload as well as reduction in patient "burden". aspects of cost effectiveness will be included in the final analysis. results of the study would allow decision-making based on evidence based medicine on the "best" therapeutic options available for newly-diagnosed as well as existing primary hemochromatosis patients.

in this project we plan to evaluate the effectiveness of erythrocytapheresis against phlebotomy, both regarding the impact on the reduction in iron overload as well as reduction in patient "burden". aspects of cost effectiveness will be included in the final analysis. the results of the study would allow decision-making based on evidence based medicine on the "best" therapeutic options available for newly-diagnosed as well as existing primary hemochromatosis patients.

Eligibility criteria:
inclusion criteria: * hereditary haemochromatosis patients exclusion criteria: * malignancies, severe arrhythmias, congestive heart failure and/or recent angina, severe liver disease, epileptic seizures preceding in last 3 months before planned treatment
comparative pk pd study in pah patients (fox vs. i-neb)

Conditions: Pulmonary Arterial Hypertension

Summary: administration of iloprost aerosol comparing two nebulizers: fox and i-neb


Eligibility criteria:
inclusion criteria: * male or female aged ≥ 18 years * current diagnosis of pulmonary hypertension (updated dana point classification 1). * current inhalative therapy with 5 µg iloprost using the i-neb nebulizer * who functional class iii at the time of the patient's commencement of inhalative therapy with iloprost * hemodynamic diagnosis of pulmonary arterial hypertension(pah) showing mean pulmonary arterial pressure (mpap) \> 25 mmhg, pulmonary capillary wedge pressure (pcwp) or left ventricular end diastolic pressure (lvedp) \ 320 dyn•s•cm-5 * if non-specific types of chronic treatment for pah are being administered: stable dosage of these for at least the 4 weeks up to screening * if pah-specific drug treatments (such as endothelin receptor antagonist (era) or phosphodiesterase-5 (pde5) inhibitors) are being administered: stable dosage of these for at least the 3 months up to screening. exclusion criteria: * pah related to any other etiology, especially to pulmonary veno-occlusive disease (pvod) * clinically relevant obstructive lung disease * evidence of thromboembolic disease (probable pulmonary embolism) within 3 years before screening * cerebrovascular events within 3 months before screening * atrial septostomy within the 6 months before screening * severe arrhythmia, or severe coronary heart disease or unstable angina, or myocardial infarction within 6 months before screening, or congenital or acquired valvular defects with clinically relevant myocardial function disorders unrelated to pah * systolic blood pressure \ 160 mmhg or diastolic bp \> 100 mmhg) * hepatic impairment (child pugh b, c) or chronic renal insufficiency (creatinine \> 2.5 mg/dl) and /or requirement of dialysis * clinically relevant bleedings disorders or conditions with increased risk for hemorrhages (active ulcers, trauma etc.) * addition or dose change of pah specific drug treatments such as era or pde5 inhibitors within 3 months before screening, or addition or dose change of non-specific treatments for pah such as calcium channel blockers, nitrates, digitalis, diuretics within 4 weeks before screening, or any kind of prostanoid other than those mentioned in inclusion criteria within less than 5 half-lives before treatment