Kornimate/medical-research-clean huggingface dataset:
safety study of calcineurin-inhibitor-free immunosuppression after liver transplantation

Conditions: Liver Transplantation; Chronic Renal Insufficiency

Summary: a prospective, non-randomized two stage monocentric phase ii clinical trial to evaluate a de-novo calcineurin-inhibitor (cni)-free immunosuppressive regimen based on induction therapy with anti-cd25 monoclonal anti-body (basiliximab), mycophenolic acid (mpa), and mammalian target of rapamycin (mtor) - inhibition with everolimus to determine its safety and to investigate the preliminary efficacy in patients with impaired renal function at the time-point of liver transplantation (olt) with regards to the incidence of steroid resistant acute rejection within the first 30 days after liver transplantation.


Eligibility criteria:
inclusion criteria: 1. patients undergoing primary liver transplantation. 2. patients older than 18 years. 3. patients with a hepatorenal syndrome. 4. female patients of childbearing potential willing to perform a highly effective contraception during the study and 12 weeks after conclusion of study participation. 5. egfr \< 50 ml/min at the time point of transplantation. 6. serum creatinine levels \> 1.5 mg/dl at the time-point of transplantation. exclusion criteria: 1. patients with pre-transplant renal replacement therapy \> 14 days. 2. patients with a reason for renal impairment other than a hepatorenal syndrome. 3. patients with a known hypersensitivity to mtor-inhibitors. 4. patients with a known hypersensitivity to mycophenolate acid. 5. patients with a known hypersensitivity to anti cd 25-monoclonal antibodies. 6. patients with platelets \< 50.000/nl prior to initiation of therapy with mtor inhibition. 7. patients with triglycerides \> 350 mg/dl and cholesterol \> 300 mg/dl refractory to optimal medical treatment prior to initiation of therapy with mtor inhibition. 8. severe systemic infections and wound-healing disturbances. 9. multiple organ graft recipients. 10. patients with signs of a hepatic artery stenosis directly prior to initiation of therapy with everolimus. 11. pregnant women will not be included in the study. 12. patients with a psychological, familial, sociologic or geographic condition potentially hampering compliance with the study protocol and follow-up schedule. 13. patients under guardianship (e.g., individuals who are not able to freely give their informed consent).

Keywords: renal impairment liver transplantation chronic renal insufficiency
a study to investigate the interaction between givosiran and a 5-probe drug cocktail in patients with acute intermittent porphyria (aip)

Conditions: Acute Intermittent Porphyria (AIP); Acute Hepatic Porphyria (AHP); Porphyria, Acute Intermittent; Acute Porphyria

Summary: the purpose of this study is to evaluate the effect of givosiran on the pharmacokinetics of the 5-probe cocktail of midazolam, caffeine, losartan, omeprazole, and dextromethorphan, and their metabolites, in asymptomatic patients with acute intermittent porphyria.


Eligibility criteria:
inclusion criteria: * 18 to 65 years old * weight between 45kg and 110kg, inclusive, if male * weight between 45kg and 100 kg, inclusive, if female * diagnosis of acute intermittent porphyria (aip) * elevated urine pbg level * not be pregnant or breast feeding, and must be willing to use a highly effective method of contraception exclusion criteria: * clinically significant abnormal laboratory results * experienced an acute porphyria attack within past 12 months * history of multiple drug allergies, intolerances or sensitivities * history of recurrent pancreatitis * received an experimental drug, within 3 months of dosing * donated or lost an excessive amount of blood within 60 days of dosing

Keywords: rnai therapeutic porphyria acute hepatic porphyria (ahp) acute intermittent porphyria (aip)
investigate the diagnostic value and possibilities of oct in non-melanoma skin cancer.

Conditions: Skin Neoplasms

Summary: we will do systematic and functional assessment of non-melanoma skin cancer including precancerous lesions by oct imaging and other diagnostic methods. the systematic assessment will be comparison of clinical diagnosis, histopathology, oct images, spectrophotometry and high frequency ultrasound of non-melanoma skin cancer functional exploration of non-melanoma skin cancer is done with doppler-oct and polarization-sensitive-oct.

optimal management of skin malignancies relies on early and accurate diagnosis. the reference standard in skin cancer is biopsy and histopathological assessment from a clinical suspicious skin lesion. the clinical diagnosis of skin cancer has sensitivity ranging from 50% to 90 % and specificity around 70% to 80% depending on the population studied and the experience of the clinician. a rapid, non-invasive technique that could be used for characterization of skin lesions prior to biopsy would be valuable. in some patients with multiple, recurrent skin tumours the need for numerous biopsies in the same area is problematic, both cosmetically and diagnostically, as the cancer can be hidden under scar tissue. the biopsy has several weaknesses: the biopsy must be done exactly in the tumour, and it does not delineate the tumour borders. biopsy from skin is in general easy, but there are problematic places such as the t-zone in the face, the eyelids and the ears. notably these places are areas where most types of skin cancer exhibit aggressive, invasive growth and have a high recurrence rate. oct is a novel, non-invasive optical imaging technology. it can provide cross-sectional tomographic images of tissue pathology in situ and in real time, without the need for excision and processing of specimens, as in conventional histopathology. oct uses harmless, infrared light to create high-resolution images of tissue. oct provides cross-sectional images of structures below the tissue surface in analogy to histopathology. hence oct can function as an "optical biopsy" providing images of tissue structure on the micron scale. for example, oct could be used where standard excisional biopsy is hazardous or impossible, and oct could reduce sampling errors associated with excisional biopsy.

Eligibility criteria:
inclusion criteria: * patients above the age of 18 years with primary non-melanoma skin cancer nmsc or precancerous lesions from the dermatology department, and the plastic surgery department at roskilde hospital, and from office based dermatologist in roskilde county. patients will only be recruited after informed consent. exclusion criteria: * pregnancy. * to avoid the potential bias of scar tissue in the oct images we will not include oct images from recurrent nmsc in this study. * patients will be excluded from the study if they are not able to give an informed consent. staff from the dermatology, internal medicine and plastic surgery departments at ras cannot be included in the phase i/phase 2 study. * gender: both * age limits: 18- no max

Keywords: optical coherence tomography
ecls versus impella™ as bridge to lvad (eci-blad)

Conditions: Cardiogenic Shock; End-stage Heart Failure

Summary: in this retrospective observational multicenter study the authors tested the hypothesis that the use of impella™ pump as bridge to bridge, by giving the opportunity of active rehabilitation, should improve patient's outcomes after the implantation of left ventricular assist device (lvad).

end stage heart failure patients admitted in intensive care unit (icu) for refractory cardiogenic shock requiring short-term mechanical circulatory support as a bridge to a long-term lvad might benefit from early mobilization and rehabilitation with impella™ inserted via the axillary artery. the aim of this study is to compare the early rehabilitation and outcomes after lvad implantation between patients previously treated by impella™ or extracorporeal life support (ecls)

Eligibility criteria:
inclusion criteria: * patients supported with impella™ or ecls for refractory cardiogenic shock as a bridge to long duration lvad exclusion criteria: * patient refusing to give access to their medical chart * guardianship and curactorship * deprived of liberty * short term mechanical circulatory system weaned before lvad implantation

Keywords: cardiogenic shock end stage heart failure bridge to bridge bridge to decision left ventricular assist device impella™ ecls
humanized cd19 chimeric antigen receptor (car)-modified t cell therapy in treating patients with b-cell malignancies

Conditions: Acute Lymphoblastic Leukemia; B Cell Lymphoma

Summary: this is a single arm, open-label study to evaluate the safety and efficacy of humanized anti-cd19 car-t cells in patients with relapsed or refractory b cell malignancies.

chimeric antigen receptor (car)-modified t cells (car-t cells) have the capabilities to recognize tumor associated antigen and kill tumor cells specifically. car-t therapy showed great effect on patients with relapsed or refractory b cell malignancies. to improve the efficacy and safety, the researchers designed a second-generation humanized car, consisting of humanized cd19 single chain variable fragment (scfv) and cd137 costimulatory domain. this study aims to evaluate the safety and effectiveness of humanized anti-cd19 car-t cells in patients with relapsed or refractory b cell malignancies.

Eligibility criteria:
inclusion criteria: 1. the patient is pathologically and histologically confirmed as cd19 + b cell tumors, and has no effective treatment options currently, such as chemotherapy; or relapsed after auto-hsct/allo-hsct; or patients voluntarily choose cd19 car-t cells as a first treatment; 2. b cell hematological malignancies include the following three categories: a. b-cell acute lymphocytic leukemia (b-all); b. indolent b-cell lymphoma (cll, fl, mzl, lpl); c. aggressive b-cell lymphoma (dlbcl, bl, mcl); 3. aged from 14 to 70 years old; 4. expected survival time \> 6 months; 5. female patients around childbearing age, negative pregnancy test before trial, and agreed to take effective contraceptive measures during the trial until the last visit; 6. voluntarily participate in this experiment and sign informed consent by themself, or legally authorized representative. exclusion criteria: 1. with a history of epilepsy or other central nervous system diseases; 2. having graft-versus-host reaction, requires the use of immunosuppressants; 3. the presence of clinically significant cardiovascular disease, such as uncontrolled or symptomatic arrhythmias, congestive heart failure or myocardial infarction within recent six months, or heart disease with cardiac function in any grade 3 (moderate) or 4 ( severe) (according to the new york heart association (nyha) functional classification system); 4. pregnant or lactating women (safety of this therapy for the unborn child is unknown); 5. not curable active infection; 6. patients with active hepatitis b or hepatitis c virus infection; 7. combined use of systemic steroids within two weeks (except use of inhaled steroid recently or currently); 8. using product of gene therapy before; 9. creatinine\> 2.5 mg / dl (221.0 umol/l); alt / ast\> 3 x the normal amount; bilirubin\> 2.0 mg / dl (34.2 umol/l); 10. patients suffering from other uncontrolled diseases, and researchers believe that the patient is not suitable for trial; 11. patients with hiv-infection; 12. any situation that may increase the risk of patients or interfere with test results.
the effects of muscles strength on physical performance in patients with multiple sclerosis

Conditions: Multiple Sclerosis

Summary: muscle weakness, which is one of the most common symptoms in patients with ms, limits the activities of daily life activities of patients by causing balance and gait disturbance. lower extremity muscle strengths of ms patients are reported to be weaker than healthy individuals. broekmans et al. showed that the weakness of the knee flexor and extensor muscles in patients with ms caused a decrease in walking distance and they are important determinants of walking capacity. the effects of the endurance and strength of core muscles, as well as the extremity muscles, are important on physical performance. the weakness of the extremities and core muscles in ms patients also affects the sit-to-stand performance negatively as well as a decrease in walking speed and capacity. in this study, it was aimed to investigate the effects of extremity and core muscle strength on walking and sitting-up performance of ms patients.

patients with ms between 0-5,5 score according to the extended disability status scale (edss) and healthy individuals of similar age and sex to patients will be included in the study. the strength of the extremity and core muscles, walking capacity, and sit-to-stand performance will be evaluated once. investigators will use descriptive statistics and t-tests to compare variables between groups. investigators will examine the correlations between variables using pearson bivariate correlations. the significance level is set at p\<0,05

Eligibility criteria:
inclusion criteria: * participants who 18-65 years of age * ms patients who are ambulatory (expanded disability status scale score ≤ 5,5 ) in a stable phase of the disease, without relapses in the last 3 month. exclusion criteria: * participants who have orthopedic, vision, hearing, or perception problems

Keywords: strength walking sit-to-stand
antimicrobial drug use and resistant staphylococcus aureus

Conditions: Staphylococcus Aureus

Summary: the purpose of this investigation is to study the relationships between antimicrobial stewardship program efforts, antimicrobial drug use, and infection control efforts to the incidence rates of hospital acquired infections with staphylococcus aureus in a sample of us academic medical center hospitals.

hospitalized patients can become infected with a variety of microorganisms, but infections caused by staphylococcus aureus (i.e., "staph" infections) are particularly common. the main strategy to reduce the number of patients infected with staph. aureus is to decrease cross-transmission from one patient to another. in addition, increasing evidence suggests that improvements in antimicrobial drug use--promoted by hospital antimicrobial stewardship programs (asps) -- may also favorably impact rates of staph. aureus infections. while many staphylococcal strains remain susceptible to an old drug called methicillin (methicillin-susceptible staph aureus, or mssa), many staph. aureus are methicillin-resistant (mrsa). the drug of choice for mrsa has historically been vancomycin, and vancomycin is now the most commonly prescribed antibiotic in us teaching hospitals. vancomycin-resistant staph. aureus (vrsa) is still uncommon, but some staph. aureus are developing "low level" resistance to vancomycin. these strains are often called s. aureus with mic "creep" to vancomycin (sa-miccreep), and staphylococcus aureus with heterogeneous resistance to vancomycin (hvisa), but the epidemiology, clinical significance and risk factors for these organisms are not well described. we will survey uhc participating hospitals to learn more about these organisms, the drug and asp related risk factors, and whether hospitals are trying to identify these organisms.

Eligibility criteria:
inclusion criteria: * na exclusion criteria: * na

Keywords: staphylococcus aureus antimicrobial stewardship antibacterial resistance vancomycin
intermittent therapy in hiv-1 infected patients with successful viral suppression under highly active antiretroviral therapy (haart)

Conditions: HIV Infections

Summary: although lifelong continuous therapy with haart remains the standard of care of hiv infection, allowing to achieve undetectable plasma viral rna, restore cd4 cell count and provide substantial decline in hiv-related morbidity and mortality, long-term toxicity associated with antiretroviral therapy is a real concern. the purpose of this study is to compare an intermittent therapy strategy to a continuous treatment in patients with chronic and well controlled hiv-1 infection.

although lifelong continuous therapy with haart remains the standard of care of hiv infection, allowing to achieve undetectable plasma viral rna, restore cd4 cell count and provide substantial decline in hiv-related morbidity and mortality, long-term toxicity associated with antiretroviral therapy is a real concern. the purpose of this study is to compare an intermittent therapy (it) strategy (8 weeks off / 8 weeks on) to a continuous treatment (ct) in patients with chronic and well controlled hiv-1 infection (cd4 over 450/µl and plasma hiv1-rna below 200 cp/ml) under haart, over a 96-week study period. the study hypothesis is that intermittent therapy is not inferior to continuous therapy in maintaining a cd4 cell above 300/µl. it will compare the proportions of and time to immunological failure (cd4 count below 300/µl confirmed by a retest 14 days later) in the it and ct groups.

Eligibility criteria:
inclusion criteria: * hiv-1 infection * cd4 cell count over 450/µl for at least 6 months prior to screening * plasma hiv1-rna below 200 cop/ml for at least 6 months prior to screening * stable and well tolerated art for at least 6 months prior to screening * acceptable methods of contraception * patient able to comply with the protocol * informed consent signed prior to (or at) screening exclusion criteria: * cd4 nadir below 100/µl * abacavir or nevirapine in the current art * hepatitis b with 3-tc, adefovir or tenofovir current therapy * current or upcoming treatment with interferon for hepatitis b or c * history of aids-defining event in the 18 months prior to screening * pregnancy or breast feeding

Keywords: hiv infections
lifestyle modification programme for hiv-infected individuals with fatty liver

Conditions: NAFLD; Hiv

Summary: non-alcoholic fatty liver disease (nafld) is rising in prevalence, and will likely become the predominant cause of chronic liver disease in hiv-infected individuals. metabolic factors and obesity are important risk factors for nafld in hiv-infected individuals. there is currently no approved effective pharmacological treatment for fatty liver disease. therefore, lifestyle modification directing at weight loss is currently the cornerstone of treatment for fatty liver disease in the general population. hypocaloric diets can improve fatty liver in the general population, but the most effective specific dietary interventions are yet to be elucidated. the study aims to 1. determine the efficacy of a lifestyle modification programme in inducing resolution of nafld in hiv-infected individuals 2. to determine the efficacy of a lifestyle modification programme in improving insulin resistance, pro-inflammatory markers, and liver fibrosis in hiv-infected individuals with fatty liver disease 3. to determine changes in intestinal microbiome secondary to the lifestyle modification programme, and the association with resolution of nafld in this group of patients.


Eligibility criteria:
inclusion criteria: * age 18 years or above * positive hiv antibody, on anti-retroviral therapy * hiv viral load ≤50 copies/ml for ≥6 months * intrahepatic triglyceride content ≥5% on magnetic resonance spectroscopy exclusion criteria: * current aids-defining illness * active malignancy, or history of malignancy within the last 5 years * hepatitis b and/or hepatitis c co-infection, as determined by positive hbsag and anti--hcv antibody * alcohol consumption \>30g per week in men or 20g per week in women * alanine aminotransferase (alt) above 10 times the upper limit of normal * liver decompensation (as evidenced by bilirubin above 50 µmol/l, platelet count below 100 × 109/l, prothrombin time above 1.3 times the upper limit of normal, albumin below 35 g/l, presence of ascites or varices).
eldoa technique versus lumbar snags with motor control exercises

Conditions: Low Back Pain

Summary: study will be a randomized clinical trial to check the effects of eldoa technique versus lumbar snags with motor control exercises on pain, function and mobility in patients with chronic low back pain. duration of study will be 8 months, non probability convenience sampling technique will be used, subject following eligibility criteria from district headquarters hospital okara will be randomly allocated in two groups using computer random number generator. baseline assessment will be done. group a participants will be given baseline treatment along with eldoa exercises, group b participants will be given baseline treatment along with lumbar snags and motor control exercises for 3 weeks. assessment will be done by using numeric pain rating scale, oswestry disability index and inclinometer at baseline, at 3 weeks and a follow up will be taken at 6 weeks. 3 sessions per week will be given, data will be analyzed by using spss version 21.

lbp is a significant global health problem, and its impact is still great. in 2019, there were 6972.5 (95% ui 6190.5 to 7860.5) age-standardized point prevalence estimates for lbp worldwide, with 568.4 million (95% ui 505.0 to 640.6 million) prevalent cases. the gbd research also revealed that lbp has a worldwide point prevalence of 9.4%, with men having a greater prevalence than women (8.7% vs. 10.1%). back discomfort might arise as a result of mobility disorders, musculoskeletal sprains, incorrect spine positioning, or nucleus pulposus degeneration. there is huge literature regarding the management of low back pain and yet after the decades of research there are gaps in treatment options. the current study will compare the eldoa technique to lumbar snags with motor control exercises. the current study is novel in a way that there is very limited evidence avialbale on eldoa technique and motor control exercises. this study will provide vital insights into their efficacy and can help to guide clinical decision making for individuals with low back pain. furthermore, this study can add to the expanding body of information regarding low back pain treatment and will help to improve patient outcomes.

Eligibility criteria:
inclusion criteria: * age 18-30 * patients of both genders. * patients having chronic low back pain ( \>3 months duration) * patients with restricted range of motion (patients will be examined for active lumbar range of motion) * patients with lumbar straightening based on referral from orthopedic exclusion criteria: * history of neurological condition of hip and lumbar region. * medical red flag history (tumor, metabolic diseases, rheumatoid arthritis, osteoporosis or infection) * medical record of severe disabling chronic cardiovascular and pulmonary disease. * prescribed history of epidural steroidal injection for pain.

Keywords: core stability disability low back pain stretching exercise