Kornimate/medical-research-clean huggingface dataset:
pilot study to detect sars-cov-2 virus in sperm

Conditions: Covid19

Summary: this is a prospective study involving 50 patients, with acute sars-cov-2 infection and a positive rna detection. men will give semen, saliva, urine and blood specimens following rt-pcr diagnosis and 15, 30, 60 and 90 days after. sars-cov-2 rna will be detected in seminal plasma, native semen cells and processed spermatozoa. the purpose of this study is to seek the presence of sars-cov-2 in semen, to determine its localization and infectiousness and to assess the efficiency of spermatozoa processing methods to obtain virus free spermatozoa.

since the end of 2019, an epidemic of sars-cov-2 infections (covid-19) began in china and is now a global pandemic affecting more than 3 millions of people. droplets and close contact are the most common routes of transmission of sars-cov-2 and aerosol transmission may be another route. researchers have detected sars-cov-2 in samples of respiratory tract, saliva, stool, gastrointestinal tract, urine, tears and conjunctival secretions of covid-19 patients. vertical transmission from mother to infant has been suspected, but not confirmed to date. information about localization of sars-cov-2 in the genital tract or shedding is poorly documented and the results of these studies were discrepant. one of two studies have reported sars-cov-2 rna in semen from six infected patients. however, there is no data on the duration of the seminal excretion of the virus, its viral load and infectiousness and on its localization in semen compartments (cells, seminal plasma, spermatozoa). the purpose of this study is to seek the presence of sars-cov-2 in semen, to determine its localization and infectiousness and to assess the efficiency of spermatozoa processing methods to obtain virus free spermatozoa. this is a prospective study involving 50 patients, with acute sars-cov-2 infection and a positive rna detection. men will give semen, saliva, urine and blood specimens following rt-pcr diagnosis and 15, 30, 60 and 90 days after. sars-cov-2 rna will be detected in seminal plasma, native semen cells and processed spermatozoa.

Eligibility criteria:
inclusion criteria: * patient aged 18 to 50, male. * patient in acute phase of infection with sars-cov-2 and whose rt-pcr shows the viral genome in the nasopharyngeal or salivary sample or in any other sample. * patient who can come to the laboratory for samples * patient having given his free and informed consent and having signed the consent * patient affiliated to a social security scheme or equivalent exclusion criteria: * patient having previously consulted for male infertility or having previously carried out a semen examination which was abnormal (who standard) * patient with ejaculation disorder or unable to take a semen sample or with an abnormal semen volume (\<1.5 ml). * patient who would present serious clinical signs that would not allow him to travel to the investigating center to take samples. * patient under a protection regime for adults (including guardianship, curatorship or safeguard of justice.

Keywords: covid19 sars-cov infection semen
spme for metabolomics and concomitant measurements of rocuronium bromide levels in liver transplantation

Conditions: Liver Failure

Summary: standard anesthetic management of liver transplantation patients includes a general anesthetic using multiple drugs, including the neuromuscular relaxant rocuronium. pharmacokinetic modelling of this agent has been poorly described during liver transplantation, which impacts on appropriate dosing of this agent within this population where plasma concentrations can vary with fluid shifts and hepatic drug metabolism during the various phases of liver transplantation. plasma drug and drug metabolite concentrations will be measured using the technique of solid phase micro-extraction (spme). measuring and correlating the levels of rocuronium and other liver metabolites with the degree of post transplantation hepatic dysfunction may serve as a simple and cost-effective marker to aid diagnosis, identify those at risk of hepatic dysfunction and potentially grade the severity


Eligibility criteria:
inclusion criteria: * first time liver transplant recipients above 18 years of age * elective cadaveric or living donor liver transplant patients will be recruited exclusion criteria: * all patients under 18 years of age * unable to give consent

Keywords: liver transplantation solid phase micro extraction rocuronium metabolomics pharmacokinetics clinical marker
an experimental study on the effect of tenofovir amibufenamide on blood lipid during anti-hbv treatment

Conditions: Hepatitis B, Chronic; Lipid Disorder

Summary: in june 2021, chinese food and drug administration approved the launch of the self-developed new drug tenofovir amibufenamide(tmf). tmf is a new second generation of tenofovir(tfv) and its effect on blood lipids is unclear. our study aims to figure out the effect of tmf on serum lipid level in the process of antiviral therapy for chronic hepatitis b patients.

in june 2021, chinese food and drug administration approved the launch of the self-developed new drug tenofovir amibufenamide(tmf). tmf is the phosphoramidite precursor of tenofovir, belonging to the nucleoside reverse transcriptase and owning higher cell membrane penetration rate, which make it easier to enter hepatocytes and achieve liver-targeted therapy. meanwhile, tmf can effectively improve drug stability in plasma and reduce systemic tenofovir(tfv) exposure, and make long-term treatment safer. previous studies have shown that tenofovir disoproxil (tdf), the first generation of tfv, had the effect of lowering blood lipids. while patients who switched to tenofovir alafenamide (taf), the second generation of tfv, had elevated blood lipids. tmf is a new second generation of tfv and its effect on blood lipids is unclear. our study aims to figure out the effect of tmf on serum lipid level in the process of antiviral therapy for chronic hepatitis b patients.

Eligibility criteria:
inclusion criteria: 1. age 18-70 years old; 2. chronic hepatitis b patients who meet the chb diagnostic criteria of "guidelines for the prevention and treatment of chronic hepatitis b (chinese 2019 version)"; 3. hbv-dna can be detected (≥20iu/ml); 4. with or without liver cirrhosis caused by hepatitis b; 5. the treatment plan is tmf antiviral therapy, and no other antiviral drugs are used for at least 1 year before; 6. the clinical data are relatively complete, and the follow-up time reaches 24 weeks (6 months). exclusion criteria: 1. patients with primary liver cancer or liver metastases; 2. combined with hepatitis a virus, hepatitis c virus, hepatitis d virus, hepatitis e virus and human immunodeficiency virus infection; 3. combined with alcoholic liver disease, drug-induced liver disease, autoimmune liver disease and liver disease caused by other factors; 4. history of treatment of dysglycemia and dyslipidemia; 5. patients with lactose intolerance; 6. pregnant women and lactating women; 7. patients with other serious systemic diseases.

Keywords: tenofovir amibufenamide
trial of vemurafenib and cobimetinib in patients with advanced brafv600 mutant melanoma

Conditions: Melanoma

Summary: this trial explores the immunologic effects of vemurafenib (braf inhibitor) and cobimetinib (mek inhibitor), administered alone and in combination, to patients with advanced braf v600e/k mutant melanoma.


Eligibility criteria:
inclusion criteria: * signed informed consent * signed hiv testing consent * life expectancy ≥ 12 weeks * able to swallow pills * ecog performance status 2 or less * adequate bone marrow function * adequate renal function * adequate liver function * negative urine pregnancy test within 7 days prior to commencement of dosing in premenopausal women * histological diagnosis of unresectable ajcc stage iii or stage iv, brafv600e/k mutant melanoma * measurable disease * accessible tumor that can be biopsied * naive to targeted therapy (prior immune-based therapy in the adjuvant setting or for advanced disease will be allowed if \>2 weeks from study entry) exclusion criteria: * active systemic infection * active autoimmune disease or history of known or suspected autoimmune disease * active brain metastases or leptomeningeal metastases * treatment with any immunomodulatory medication within 4 weeks of initiation of study therapy. * positive test for hepatitis b virus * positive test for hepatitis c virus * positive test for human immunodeficiency virus (hiv) * pregnant, lactating or breast feeding women * localized radiation therapy within the last 14 days * history of malabsorption * no consumption of the following within 7 days prior to start of treatment: * st. john's wort or hyperforin (potent cytochrome p450 cyp3a4 enzyme inducer) * grapefruit juice (potent cytochrome p450 cyp3a4 enzyme inhibitor * history or evidence of cardiovascular risk * history or evidence of retinal pathology

Keywords: immunotherapy vemurafenib cobimetinib
connect for health pediatric weight management program

Conditions: Overweight and Obesity; Severe Obesity

Summary: the overall aim of this study is to disseminate the evidence-based connect for health program, specifically targeting pediatric primary care practices that deliver care to low-income children in the us who have a disproportionately high prevalence of childhood obesity and evaluate the effectiveness of the program implementation and dissemination.


Eligibility criteria:
inclusion criteria: * all children receiving primary care at the participating health centers across the three health systems

Keywords: overweight obesity pediatric implementation dissemination
evaluation of safety & tolerability of multiple dose regimens of chf 5074 and exploration of effects on potential markers of clinical efficacy in patients with mild cognitive impairment - prolonged open label extension phase

Conditions: Alzheimer's Disease

Summary: the purpose of the study is to evaluate the safety and tolerability of ascending oral doses of chf 5074 after prolonged administration to patients with mild cognitive impairment.


Eligibility criteria:
inclusion criteria: * diagnosis of amnestic or non-amnestic mild cognitive impairment. * mini-mental state examination score higher than 24 at screening. * mri scan of the brain at screening with fluid-attenuation inversion recovery (flair) and t2\*-weighted gradient-recalled-echo (gre) sequences. exclusion criteria: * diagnosis of alzheimer's disease according to the (dsm-iv-tr) or nincds-adrda criteria. * any medical condition that could explain the patients cognitive deficits. * ct or mri brain imaging results obtained within 12 months prior to baseline showing evidence of infection, infarction, or focal lesions of clinical significance * mri scan at screening showing more than 4 cerebral microhemorrhages (lesions with diameter ≤ 10 mm). * geriatric depression scale (30-point scale) score \> 9 at screening. * history of stroke. * modified hachinski ischemic scale score \> 4 at screening. * women of childbearing potential. * vitamin b12 or folate deficiency. * diagnosis of schizophrenia or recurrent mood disorder (including unipolar and bipolar disorders) within 3 years of screening. * current diagnosis of peptic ulcer or gastrointestinal bleeding within the last year and/or chronic inflammatory bowel disease. * concomitant use of donepezil at doses \> 5 mg/day or other cholinesterase inhibitors (rivastigmine or galantamine) at any dose. * concomitant use of memantine at dose \> 20 mg/day. * concomitant use of psychoactive drugs (sedatives, hypnotics, etc).
treatment of severe alzheimer's disease: evaluation of efficacy and safety of galantamine hydrobromide in a controlled study

Conditions: Dementia; Alzheimer Disease

Summary: the purpose of this study is to assess the effectiveness and safety of galantamine hydrobromide treatment in patients with severe alzheimer's disease.

this is a multicenter, 1-year study that includes a randomized, 6-month, double-blind, placebo-controlled phase and a 6-month open-label extension of galantamine hydrobromide treatment in subjects with severe alzheimer's disease. the open-label extension is optional for al patients. patients eligible for the study will be randomized to treatment with either galantamine hydrobromide or placebo over 6 months for the first phase of the study. the principal measures include the results of the severe impairment battery and the minimum data set-activities of daily living tests, to assess aspects of cognition and behavior, and impact on the patient's ability to perform normal daily activities. additional evaluations include the neuro-psychiatric inventory-nursing home version measure and 2 subscales of the minimum data set tests to further assess patients behavior, social and physical functioning, the level of caregiver support needed, and impact to the patient's caregiver; the mini-mental state examination, to assess cognitive abilities; and external health-and social-service use. safety and tolerability will be evaluated on the basis of adverse event reports, physical examination, electrocardiograms, vital signs, and laboratory parameters. the study hypothesis is that treatment with galantamine, compared with placebo, will significantly improve cognition and ability to function in patients with severe alzheimer's disease, and is generally well-tolerated. galantamine hydrobromide tablets taken by mouth two times daily: 4 weeks at 8 milligrams (mg)/day, 4 weeks at 16 mg/day, increased to 24 mg/day for the remainder of the 6 months. dose may be reduced at investigator's discretion. galatamine hydrobromide for additional 6 months in open-label phase.

Eligibility criteria:
inclusion criteria: * diagnosis of alzheimer's type dementia, rated as severe * progressive worsening of memory and other cognitive functions * brain imaging (ctor mri scan) within last 3 years * ability to be mobile (aided or unaided) with sufficient vision and hearing to comply with testing. exclusion criteria: * dementia caused by cerebrovascular disease * disturbances of consciousness, delirium, psychosis * severe aphasia * or major sensorimotor impairment * cognitive impairment due to acute cerebral trauma, hypoxic cerebral damage, vitamin deficiency, infections, primary of metastatic cerebral neoplasia, endocrine or metabolic disease or mental retardation, pregnant or nursing women or those without adequate contraception.

Keywords: dementia cognition function alzheimer disease behavioral symptoms galantamine hydrobromide
clinical application of annual liver multiscan and mrcp+ in primary sclerosing cholangitis

Conditions: Primary Sclerosing Cholangitis

Summary: primary sclerosing cholangitis (psc) is a chronic progressive biliary disease that affects approximately 1200 patients in the netherlands and around 80,000 in the western world. it is often accompanied by ulcerative colitis (uc) or crohn's disease affecting the large bowel. the cause of psc is unknown, there is no medical therapy available that has proven to halt disease progression and the median time until death or liver transplantation is 13-21 years. diagnosis is made by magnetic resonance cholangiography (mrc), or in the case of so called small duct disease by liver biopsy. due to the heterogeneous disease course and the relatively low clinical event rate of 5% per year it is difficult to predict prognosis of individual patients or to recommend any surveillance strategy for malignancies. also, the lack of surrogate endpoints impedes performing clinical research. recently, two new post-processing tools have been developed to characterize and quantify abnormalities in the biliary tree as well as excretory function captured by mrc. these tools called mrcp+ (quantitative magnetic resonance cholangiopancreatography +) and livermultiscan (lms) hold the prospect of adequately depicting and quantifying lesions of the biliary tree as well as capturing functional derailment. however, several features must be tested before the utility of this tools in clinical patient care can be concluded. therefore, the aim of this study is to investigate the utility of these novel techniques in monitoring disease activity by performing consecutive annual mri's.


Eligibility criteria:
inclusion criteria: * established psc diagnosis according to the ipscsg definitions * age ≥ 18 * able to give informed consent exclusion criteria: * post ltx * known allergy for mri contrast agents, implants non-compatible with mri or extreme claustrophobia causing discontinuation of mri studies.
pressure and diabetic foot

Conditions: Diabetes and Risk of Diabetic Foot Ulcer

Summary: diabetic foot ulcer (dfu) is a worldwide burden in the management of patients with diabetes. peripheral neuropathy has a key role in the physiopathology of dfu. others factors as skin vulnerability to plantar pressure, glycation of skin protein, articular rigidity, vascular component and abnormal foot plantar pressure are also important to take into account. the aim of the study is to assess prospectively different factors involved in dfu pathogenesis notably the neurovascular response to non noxious pressure.


Eligibility criteria:
inclusion criteria: * age \>18 years * type 2 diabetic subject * absence of active diabetic foot ulcer * patients "grade 0", "grade 1", "grade 2" or "grade 3" of the international working group on diabetic foot risk classification defined by: * absence of alteration of perception of monofilament 10g at the level of the plantar arch for the "grade 0" * alteration of perception of monofilament 10g at the level of the plantar arch for the "grade 1" * alteration of perception of monofilament 10g at the level of the plantar arch associated with foot deformity and / or an arteriopathy defined by the absence of perception of one of the two peripheral pulses for the "grade 2" * history of diabetic foot ulcer for the "grade 3" * signature of consent to participate in the study exclusion criteria: * chronic alcoholism with usual consumption of at least 5 alcoholic drinks per day * pregnancy * congenital methemoglobinemia. * porphyria * skin injured on the tibia, whatever the lesion * recent major cardiovascular history (less than 3 months) * severe renal disease (serum creatinine\> 300 μmol.l-1)

Keywords: diabetes diabetic foot ulcer plantar pressure
adaptation plan for culturally competent care (paaci) in the acute psychiatric unit.

Conditions: Mental Disorders; Cultural Competency; Psychiatric Hospitalization

Summary: this observational study aims to design, implement, and evaluate the adaptation plan for culturally competent care (paaci) in the acute psychiatric unit of parc de salut mar, barcelona. the study focuses on improving healthcare quality for immigrant patients by reducing cultural and linguistic barriers in psychiatric care. the paaci program includes educational materials in multiple languages, enhanced collaboration with social services, training for healthcare professionals in cultural competence, and the use of interpretation devices. key outcomes include reducing mechanical restraints, improving patient adherence to treatment, decreasing hospital readmissions, and increasing outpatient care engagement. the study will analyze data from immigrant patients admitted to the acute psychiatric unit one year before and after the implementation of paaci, using various clinical and patient satisfaction indicators. this initiative aims to promote equal and equitable healthcare for diverse populations, potentially serving as a model for other mental health units.

this study evaluates the implementation of the adaptation plan for culturally competent care (paaci) in an acute psychiatric unit. the project aims to improve psychiatric care for immigrant patients by addressing cultural and linguistic barriers. the study follows an observational design, comparing key clinical outcomes before and after the paaci implementation. it includes measures such as staff training in cultural competence, improved coordination with social and healthcare services, and the introduction of multilingual patient education materials. the primary focus is on enhancing healthcare equity, reducing the use of mechanical restraints, improving patient adherence to outpatient care, and decreasing hospital readmissions. findings from this study may inform future adaptations of culturally competent care models in psychiatric settings.

Eligibility criteria:
inclusion criteria: * immigrant patients admitted to the acute psychiatric unit * age 18 or older * hospitalization during the study period (12 months post-paaci implementation) exclusion criteria: * patients with severe cognitive impairment preventing informed consent * individuals with acute medical conditions requiring transfer to another service * refusal to participate or withdraw consent

Keywords: cultural competence mental health equity psychiatric care immigrant health acute psychiatric unit cross-cultural psychiatry health disparities
clinical trial of simvastatin to treat generalized vitiligo

Conditions: Vitiligo

Summary: the investigators purpose is to initiate a phase ii, randomized, placebo-controlled clinical trial to test simvastatin, an fda-approved medication for hypercholesterolemia, as a new treatment for vitiligo. the aims of this placebo-controlled study seek to determine the safety and potential efficacy of simvastatin 80mg daily versus placebo in adult male patients with generalized vitiligo. additionally, the investigators will collect blood to examine the effect of simvastatin on autoreactive cd8+ t cells in vitiligo patients.

vitiligo is an autoimmune disease caused by autoreactive cd8+ t lymphocytes that target melanocytes, and interferon-γ-induced cxcl10 plays an important role.1 simvastatin inhibits interferon-γ signaling by blocking activation of stat12 and prevented and reversed disease in our mouse model.3 a case report described a patient with vitiligo who repigmented with simvastatin.4 we conducted a small, randomized, double-blind, placebo-controlled, phase ii clinical trial to test simvastatin as a treatment for vitiligo. after obtaining informed consent, we enrolled men ages 18 to 64 years with vitiligo affecting 3% to 50% of their body surface area (bsa). we excluded patients with a segmental presentation; those already taking 3-hydroxy-3-methylglutaryl-coenzyme a reductase inhibitor; those with existing thyroid disease; and women, based on their increased risk of simvastatin-induced myopathy.

Eligibility criteria:
inclusion criteria: * male gender * ages 18-64 * at least one vitiligo skin lesion measuring at least 2x2 cm in size * willing and able to understand and sign informed consent * able to complete study and comply with study procedures exclusion criteria: * history of segmental vitiligo * allergy to statin medications * use of statin medications due to cardiac risks. * use of any medications contraindicated with use of simvastatin * use of topical vitiligo treatments in past 4 weeks * use of laser or light-based vitiligo treatments within the past 8 weeks * treatment with immunomodulating oral medications in the past 4 weeks * use of statin medications in the past 8 weeks * evidence of hepatic dysfunction, personal or family history of non-alcoholic steatotic hepatitis, or personal history of hepatitis * evidence of renal dysfunction * history of myopathy or rhabdomyolysis, or elevated baseline creatinine kinase * recent history of alcohol or drug abuse * history of diabetes * untreated hypothyroidism * other conditions that require the use of interfering topical or systemic therapy * other current conditions that might interfere with study assessments such as, but not limited to, atopic dermatitis and psoriasis * clinically significant abnormal findings or conditions which might, in the opinion of the principal investigator, interfere with study evaluations or pose a risk to subject safety during the study.

Keywords: vitiligo simvastatin