Kornimate/medical-research-clean huggingface dataset:
pharmacokinetic (pk) study of oral and iv tr-701 fa in adolescent patients

Conditions: Bacterial Infection

Summary: this is an open-label, multi-center, two-part, parallel-design study to assess the pk, safety, and tolerability of tr-701 fa and its active metabolite, tr-700, following a single oral dose (part a) or iv dose (part b) of tr-701 fa in 12 to 17 year old adolescent patients.


Eligibility criteria:
inclusion criteria: * males and females, between 12 and 17 years of age, inclusive; * receiving prophylaxis for or have a confirmed or suspected infection with gram positive bacteria and receiving concurrent antibiotic treatment with gram positive antibacterial activity * in stable condition * females must be premenarchal, surgically sterile, abstinent, or practicing an effective method of birth control * males will either be surgically sterile, abstinent, or practicing an effective method of birth control exclusion criteria: * relevant history of seizures, clinically significant cardiac arrhythmia, cystic fibrosis, moderate or severe renal impairment, or any physical condition that could interfere with the interpretation of the study results * any acute or chronic condition that, in the opinion of the investigator, would limit the patient's ability to complete and/or participate in this clinical study * physician-diagnosed migraine headaches * history of infection with hepatitis or other significant hepatic disease * females who are pregnant or breast feeding

Keywords: antibiotic adolescents receiving antibiotics
study of dengue in patients with autoimmune diseases during the epidemics of 2020 and 2021 in reunion island

Conditions: Dengue

Summary: it is not known whether there is a different clinical profile of dengue in patients with immune system dysfunction. preliminary data and previous literature suggest that autoimmune diseases, and in particular their treatment, may favour the evolution to severe forms of dengue. our research hypothesis is that the clinico-biological presentation of dengue might be different in case of autoimmune disease, either on the side of overactivation (autoimmune and auto inflammatory diseases without treatment) or immunodepression (autoimmune and auto inflammatory diseases under immunosuppressive treatment).


Eligibility criteria:
inclusion criteria: * age ≥18 years * patient with autoimmune or autoinflammatory disease * confirmed diagnosis of dengue (in 2020 or 2021): serological test, antigenic test or pcr test to confirm the diagnosis according to current criteria exclusion criteria: * minor * opposition to the re-use of data * patient not followed in reunion * protected adult (guardianship or curatorship) or under legal protection
repeated amiodarone dosing in cardiac surgical procedures

Conditions: Atrial Fibrillation

Summary: this study is a single-center, prospective, randomized, open-label trial of subjects who develop atrial fibrillation after non-emergent cardiac surgery at the university of kentucky chandler medical center (ukcmc). patients will be randomized to receive either a conventional amiodarone dosing regimen (cdr) or a repeated amiodarone bolus dosing regimen (rbdr).

this study will screen and consent approximately 150 patients undergoing non-emergent cardiac surgery. approximately 60 of these patients are likely to develop stable postoperative atrial fibrillation (poaf) in the postoperative period. amiodarone is commonly given as an initial intravenous (iv) bolus (150 mg iv) followed by a combined iv and oral load to a total dose of 8 gm. because of amiodarone's beta-blocker activity, the iv bolus in patients with poaf is associated with a reduced heart rate that may lead to restoration of nsr. for this reason, some clinicians will provide up to 5 additional iv amiodarone boluses during the drug's loading period to treat rvr.

Eligibility criteria:
inclusion criteria: * subject must be 18 years old or older * subject must be willing to give written informed consent * subject must undergo or scheduled for non-emergent cardiac surgery, including coronary artery bypass grafting (cabg), non-infectious valve repair or replacement, atrial or septal defect repair, thoracic aortic replacement surgery, or any combination of these procedures exclusion criteria: * documented allergy to amiodarone or iodine * history of atrial fibrillation or other heart conduction system abnormality * history of cardiac maze, pulmonary vein isolation, or other procedure affecting the conduction system * scheduled cardiac maze, pulmonary vein isolation, or other procedure affecting the conduction system * low cardiac index or cardiogenic shock requiring pharmacologic or mechanical support * history of pre-existing respiratory system disease requiring oxygen therapy prior to admission * history of cirrhosis or other chronic liver diseases * pregnancy or breastfeeding mothers * prisoner status
physiotherapy treatment in women with dyspareunia following gynecological cancer: a pilot study

Conditions: Gynecological Cancer; Dyspareunia

Summary: gynecological cancers represent more than half of female cancers. it has been clearly established that cancer survivors suffer from important health issues such as pain during sexual intercourse (dyspareunia) and sexual dysfunctions which sorely impact their quality of life. although it affects more than 63% of cancer survivors, the available treatments remain limited and poorly studied. cancer survivors are thus confronted with these health issues as well as relationship difficulties and psychological consequences, with limited treatment avenues. addressing pelvic floor muscle dysfunctions and loss of vaginal elasticity, pelvic floor physiotherapy was shown to be effective in reducing or even alleviating dyspareunia and improving sexual function. until now, no study investigated this treatment in gynecological cancer survivors with dyspareunia. therefore, there is a need to examine pelvic floor physiotherapy to determine whether or not gynecological cancer survivors with dyspareunia could benefit from this treatment. the objectives of this single-arm mixed-method study are to evaluate the acceptability and feasibility of a physiotherapy treatment in gynecological cancer survivors suffering from dyspareunia and to explore treatment effects. this single-arm study using mixed methods will involve three data collections (pre- and post-treatment assessments). these assessments will be carried out by physiotherapists. participants will receive physiotherapy treatment weekly in individual 60-minute sessions for 12 weeks. thirty-one gynecological cancer survivors with vulvovaginal pain during sexual intercourse for at least 3 months will be recruited. the results of this study will bring new information regarding physiotherapy treatment for this population in preparation for a definitive randomized controlled trial.


Eligibility criteria:
inclusion criteria: * history of gynecological cancer (endometrial, cervical, vaginal or other parts of the uterus) * scheduled oncological treatments completed with no signs of cancer for at least 3 months * vulvovaginal pain during sexual intercourse for at least 3 months exclusion criteria: * vulvovaginal pain before cancer and not related to sexual intercourse * medication recognized to affect pain * refuse to stop other treatments until post-treatment assessment * other conditions interfering with assessment

Keywords: pilot study feasibility study dyspareunia gynecological cancer survivors physiotherapy
skeletal muscle wasting in sars-cov-2

Conditions: Cachexia; Muscle Loss; Muscle Wasting; Muscle Atrophy; Critical Illness

Summary: the sars-cov-2 pandemic causes a major burden on patient and staff admitted/working on the intensive care unit (icu). short, and especially long admission on the icu causes major reductions in skeletal muscle mass (3-4% a day) and strength. since it is now possible to reduce mortality on the icu, short and long-term morbidity should be considered another principal endpoint after sars-cov-2 infection. cachexia is defined as 'a complex metabolic syndrome associated with underlying illness and characterized by loss of muscle mass'. its clinical features are weight loss, low albumin, anorexia, increased muscle protein breakdown and inflammation. there is strong evidence that cachexia develops rapidly in patients hospitalized for sars-cov-2 infection, especially on the icu. several mechanisms are believed to induce cachexia in sars-cov-2. firstly, the virus can interact with muscle cells, by binding to the angiotensin converting enzyme 2 (ace-2). in vitro studies have shown the virus can cause myofibrillar fragmentation into individual sarcomeres, in addition to loss of nuclear dna in cardiomyocytes. similar results were found during autopsies. on a cellular level, nothing is known about the effects of sars-cov-2 infection on skeletal muscle cells. however, up to 19.4% of patients present with myalgia and elevated levels of creatine kinases (\>200u/l), suggesting skeletal muscle injury. moreover, patients with sars-cov-2 infection are shown to have elevated levels of c-reactive protein and other inflammatory cytokines which can all affect skeletal muscles. the above mentioned factors are not the only mediators by which skeletal muscle mass might be affected in sars-cov-2. there are other known factors to affect skeletal muscle mass on the icu, i.e. immobilization and mechanical ventilation, dietary intake (anorexia) and inflammatory cytokines. sars-cov-2 infection in combination with bed rest and mechanical ventilation can lead to severe muscle wasting and functional decline resulting in long-term morbidity. until know there are no studies investigating acute skeletal muscle wasting in patients infected with sars-cov-2 and admitted to the icu. as a result, there is a need of more in-depth understanding the effects of sars-cov-2 infection on muscle wasting. an optimal characterization of these effects may lead to improvement in morbidity and even mortality in the short and long term by the establishment of evidence-based rehabilitation programs for these patients.


Eligibility criteria:
inclusion criteria: * age \>18 years * sars-cov-2 infection * expected stay to icu of \> 7 days exclusion criteria: * spinal cord injury * chronic use of corticosteroids before hospital admission
serum bdnf role as a biomarker for stroke rehabilitation

Conditions: Stroke; Biomarker; Rehabilitation; BDNF

Summary: this study aims to develop the quantitative biomarker to establish the individualized strategy in stroke rehabilitation. brain-derived neurotrophic factor (bdnf) acts on certain neurons of the central nervous system (cns) helping to support the survival of existing neurons, and encourage the growth and differentiation of new neurons and synapses. bdnf in cns can be assessed by analysing serum bdnf. the final objective of this study is to demonstrate a role of biomarker of bdnf in stroke rehabilitation to establish the individualized strategy.

serum bdnf, probdnf and mmp-9 in all participants will be measured before and after the comprehensive inpatient rehabilitation during subacute stroke phase. at 3 months after stroke onset, serum bdnf, probdnf and mmp-9 will also be measured. in addition, motor impairment with fugl-meyer assessement will be assessed at same time points with serum analysis. we will compare potential serum biomarkers with motor impairment in stroke patients

Eligibility criteria:
inclusion criteria: * unilateral stroke patients * admission to the rehabilitation department before 1 month after stroke onset * mild to severe motor impairment at time of transferring to the rehabilitation department exclusion criteria: * progressive or unstable stroke * pre-existing and active major neurological disease * pre-existing and active major psychiatric disease * advanced liver, kidney, cardiac, or pulmonary disease * a terminal medical diagnosis consistent with survival \< 1 year) * pregnant or lactating woman
a study of guselkumab in participants with active psoriatic arthritis

Conditions: Arthritis, Psoriatic

Summary: the purpose of this study is to evaluate the efficacy of guselkumab treatment in participants with active psoriatic arthritis (psa) by assessing the reduction in signs and symptoms of psa.


Eligibility criteria:
inclusion criteria: * have active psoriatic arthritis (psa) despite previous non-biologic disease-modifying antirheumatic drug (dmard), apremilast, and/or nonsteroidal anti-inflammatory drug (nsaid) therapy * have a diagnosis of psa for at least 6 months before the first administration of study agent and meet classification criteria for psoriatic arthritis (caspar) at screening * have active psa as defined by: at least 3 swollen joints and 3 tender joints at screening and at baseline; and c-reactive protein (crp) greater than or equal to (\>=) 0.3 milligrams per deciliter (mg/dl) at screening from the central laboratory * have \>= 2 joints with erosions on baseline radiographs of the hands and feet as determined by central read * have at least one of the following psa subsets: distal interphalangeal joint involvement, polyarticular arthritis with absence of rheumatoid nodules, arthritis mutilans, asymmetric peripheral arthritis, or spondylitis with peripheral arthritis * have active plaque psoriasis, with at least one psoriatic plaque of \>= 2 centimeter (cm) diameter or nail changes consistent with psoriasis exclusion criteria: * has known allergies, hypersensitivity, or intolerance to study intervention or its excipients * has other inflammatory diseases that might confound the evaluations of benefit of guselkumab therapy, including but not limited to rheumatoid arthritis (ra), axial spondyloarthritis (as)/non-radiographic axial spondyloarthritis (nr-axspa), systemic lupus erythematosus, or lyme disease * has previously received any biologic treatment * has ever received tofacitinib, baricitinib, filgotinib, peficitinib, decernotinib, upadacitinib or any other janus kinase (jak) inhibitor * has received any systemic immunosuppressants (example, azathioprine, cyclosporine, 6 thioguanine, mercaptopurine, mycophenolate mofetil, hydroxyurea, tacrolimus) within 4 weeks of the first administration of study intervention
study of two surgical drilling techniques to treat juvenile osteochondritis dissecans of the knee

Conditions: Juvenile Osteochondritis Dissecans

Summary: the purpose of this study is to compare the functional, clinical and radiographic outcomes associated with trans-articular drilling versus retro-articular drilling, two commonly employed techniques of operative treatment for stable forms of juvenile osteochondritis dissecans (jocd) lesions. this study also aims to better define the natural history of this condition in its most commonly identified pathological state (as a stable lesion) following surgical intervention by determining the rate of radiographic healing and any need for secondary surgery.


Eligibility criteria:
inclusion criteria: * diagnosis of jocd, * lesion located on the lateral aspect of the medial femoral condyle, * lesion considered stable based on mri, * patient deemed skeletally immature based on mri, * completed a course of conservative therapy. exclusion criteria: * significant concomitant knee pathology (avn, fracture, inflammatory arthritis, acl tear, discoid/meniscal tear, etc.) * lesion healed sufficiently and surgery is not recommended, * prior surgery on the affected knee, * diagnosis of metabolic bone disorder (e.g. osteogenesis imperfecta), * diagnosis of sickle cell disease, * history of prolonged corticosteroid or chemotherapy treatment,

Keywords: osteochondritis dissecans (ocd) juvenile osteochondritis dissecans (jocd) knee osteochondritis dissecans retro-articular drilling trans-articular drilling stable osteochondritis dissecans lesion
helical tomotherapy in multiple myeloma

Conditions: Multiple Myeloma

Summary: to explore the safety and efficacy of systemic radiotherapy (tbi) combined with melphalan (mel) for pretreatment of autologous hematopoietic stem cells in multiple myeloma.

this study is a single-center, prospective clinical study targeting myeloma patients requiring transplantation, and investigating the efficacy and safety of tbi combined with mel regimen for transplant pretreatment. subjects who meet the enrollment criteria were screened to enter the study and receive the corresponding regimen treatment.

Eligibility criteria:
inclusion criteria: 1. multiple myeloma patients receiving induction therapy and stem cell mobilization preparation for autologous transplantation; 2. should agree to comply with all contraceptive requirements; 3, ecog≤2; 4. total bilirubin, alt and ast \ 1000/ul and a platelet count of \>100,000/ul; 7. the expected survival time is more than 3 months; 8. written informed consent was obtained from the patients or their immediate family members. exclusion criteria: any of the following was an exclusion criterion: 1. according to the investigator's judgment, patients who cannot tolerate melphalan and radiotherapy; 2. patients with known active hepatitis b virus (hbv) or hepatitis c virus (hcv), or seropositive for human immunodeficiency virus (hiv); 3. patients with uncontrolled or severe cardiovascular disease 4. according to the protocol or the investigator's judgment, the patient has a serious physical or mental illness
assessing the variability over time of tobacco carcinogen biomarkers in smokers - 2

Conditions: Tobacco Use Disorder

Summary: lung cancer is the leading cause of cancer death in the united states. currently it remains impossible to predict which smokers will get cancer. each puff of a cigarette delivers a mixture of over 60 known carcinogens. biomarkers that quantify carcinogen levels and metabolism are a useful tool and available to use. the purpose of this study is to assess the variability of tobacco smoke carcinogen biomarker levels over one year in a group of smokers.

lung cancer is the leading cause of cancer death in the united states. approximately 90% of lung cancer is caused by cigarette smoking. while most lung cancer cases occur in smokers or ex-smokers, only 15-25% of smokers will get lung cancer. currently it remains impossible to predict which smokers will get cancer. each puff of a cigarette delivers, along with nicotine, a mixture of over 60 known carcinogens. most of these carcinogens require metabolic activation before they can negatively affect cell dna and cause cancer. biomarkers that quantify carcinogen levels and metabolic activity of carcinogens are a useful tool and available to use. the purpose of this study is to assess the variability of tobacco smoke carcinogen biomarker levels over one year in a group of smokers. this longitudinal observational study will involve a repeated measure analysis of 6 different tobacco carcinogen biomarkers. fifty current smokers who intend to continue smoking for the duration of the study will be recruited through advertisements. participants will be compensated for their time. blood samples will be collected every two months for one year. all samples will be analyzed for the 6 different carcinogen biomarkers and individual variability in biomarker levels will be assessed.

Eligibility criteria:
inclusion criteria: * currently smokes * intends to continue smoking for the 12 months following enrollment exclusion criteria: * unstable physical or mental condition
organoid models of hepatocellular carcinoma

Conditions: Hepatocellular Carcinoma; Organoids; Gut Microbiota; Tumor Microenvironment; System Disorders, Digestive; Surgery

Summary: a promising tool to elucidate the molecular characteristics of hcc are patient-derived organoids (pdos), three-dimensional cultures of cells that self-organise according to tissue-specific patterns and can be used to test the susceptibility of a specific tumour to anticancer agents. in this study, pdos for hcc will be developed that closely resemble the tumour microenvironment in vivo and mimic the crosstalk of the gut-liver axis to establish a correlation with patient prognosis and test the efficacy of available systemic therapies.

the objectives of the project will be 1) to develop hcc pdos from tumour and non-tumour patient liver tissue obtained from surgical specimens or liver biopsies; 2) to evaluate genomic and transcriptomic changes resulting from the integration of hcc pdos with patient-derived gut microbiota and host immune cells, and to assess the correlation with patient prognosis; 3) to exploit hcc pdos to test the efficacy of systemic therapies (ici and tkis) and to understand possible modifying cofactors. researchers with laboratory experience have been recruited who will focus on the construction of pdos and the analysis of immune-inflammatory pathways. state-of-the-art technologies will be used, in particular next-generation sequencing, flow cytometry, high-throughput genomic and transcriptomic analysis, ultrafiltration, drug screening, multiplex immunoassays and enzyme immunoassays. the project aims to study the mechanisms involved in the modulation of therapeutic efficacy in patients with hcc. therefore, the experimental model could be a valuable support to be integrated into real clinical practice to maximise therapeutic efficacy through a fully customised strategy.

Eligibility criteria:
inclusion criteria: * capacity to express informed consent; * age ≥18 years; * suspected radiological diagnosis of hcc or diagnosis of hcc with indications for surgical resection. exclusion criteria: * age \< 18 years; * contraindications to liver biopsy (ascites, platelets\ 1.7); * contraindications to hcc resection surgery; * active viral infection; * refusal to sign informed consent to participate in the study.
outcomes of patients with covid-19 in the intensive care unit

Conditions: Coronavirus Infections; COVID-19; Viral Pneumonia Human Coronavirus

Summary: the objective of this study is to evaluate the clinical characteristics and outcomes of critically ill patients with covid-19 admitted to the intensive care unit. a multicenter observational study.

as of 23 march 2020, a cumulative total of 332,930 confirmed cases of coronavirus disease 2019 (covid-19) were reported in 189 countries and territories worldwide. as of this time, there had been 367 total confirmed cases of covid-19, including four deaths in mexico. the clinical manifestations of patients with covid-19 are wide, asymptomatic infection, mild upper respiratory tract illness, and approximately 5% of critically ill patients with covid-19 have presented rapidly progressive respiratory failure, development of acute respiratory distress syndrome (ards), and intensive care unit (icu) admission. on march 24, 2020, the secretary of health of mexico, formally declared the beginning of phase 2. it has been estimated that many confirmed cases of covid-19 would occur, thus would result in a significant increase of hospital and icu admissions.

Eligibility criteria:
inclusion criteria: * confirmed case: critically ill patient who meets the operational definition of a suspected case and who has a confirmed diagnosis by the national network of public health laboratories recognized by the institute of epidemiological diagnosis and reference (indre) (mexico). exclusion criteria: * if a negative for sars-cov-2 result is obtained from a critically ill patient with a high index of suspicion for covid-19 virus infection. * patients who had participated in another observational study in the last 30 days prior to inclusion.

Keywords: intensive care unit critical care outcomes epidemiology