Kornimate/medical-research-clean huggingface dataset:
a study to evaluate the effect of renal function on the biological activity of telavancin

Conditions: Kidney Diseases; End Stage Renal Disease

Summary: the purpose of this study is to evaluate the effect of renal function on the biological activity of telavancin using blood samples obtained from subjects with normal renal function, severe renal impairment, and end stage renal disease.


Eligibility criteria:
inclusion criteria: * weighs at least 45 kg and body mass index of 18 to 40 kg/m2, inclusive * an estimated creatinine clearance value based on cockcroft-gault method of: * \>80 ml/min for subjects with normal renal function * \<30 ml/min for subjects with severe renal impairment * receiving hemodialysis three times a week for subjects with end stage renal impairment * if female, the subject is at least 2 years postmenopausal, surgically sterile or practicing effective birth control, and is not pregnant or lactating * good venous access exclusion criteria: * history of any clinically significant acute illness (other than renal disease and conditions related to the renal disease in renal impairment subjects, such as stable diabetes or hypertension) * has had a kidney transplant that is still functioning * history of unexplained syncope, cardiac arrest, unexplained cardiac arrythmia or torsade de pointes, structural heart disease, prolonged qt interval, or family history of long qt syndrome * known hypersensitivity to telavancin or any of the excipients in the formulation, or a history of severe allergic or anaphylactic reactions * history of consuming more than 7 units of alcoholic beverages per week, or history of alcoholism or substance abuse within past 2 years * known to be positive for human immunodeficiency virus antibody * for subjects with normal renal function, has had treatment with prescription or non-prescription drugs, including complementary and alternative medicines or over-the counter medications, with the exception of oral contraceptives, hormone replacement therapy, daily aspirin, and occasional use of acetaminophen within the past 14 days * for subjects with renal impairment, has not been on a stable dose of concomitant medications for at least 2 weeks prior to study start or is taking any medication that would interfere with the evaluation of televancin in this study * has received an experimental agent within 30 days or ten half-lives, whichever is longer, prior to study drug administration * has had any significant blood loss, donated one unit (450 ml) of blood or more, or received a transfusion of any blood or blood products within 60 days or donated plasma within 7 days prior to admission

Keywords: telavancin pharmacokinetics severe renal disease vibativ® asp9809
a safety study of sgn-cd352a for patients with relapsed/refractory multiple myeloma

Conditions: Multiple Myeloma

Summary: this study tests the safety of a drug called sgn-cd352a, to find out what its side effects are. sgn-cd352a will be given every 4 weeks to a small group of patients with multiple myeloma.

the study will have 2 parts. in the first part, different doses of sgn-cd352a will be given to different patients (each individual patient will get the same dose for all treatments). the doses will be very low at the start of the trial, and will increase only when the lower dose levels are proven safe. in the second part of the study, up to 2 dose levels that are both safe and show promising activity against mm will be given to more patients

Eligibility criteria:
inclusion criteria: * diagnosis of mm requiring systemic therapy (per the international myeloma working group \[imwg\] ). * age 18 years or older. * an eastern cooperative oncology group (ecog) performance status score of 0 or 1. * life expectancy greater than 3 months. * received at least 2 prior lines of therapy for mm including an immunomodulatory drug and a proteasome inhibitor. * measurable disease, as defined by at least one of the following: serum m protein 0.5 g/dl or higher, urine m protein 200 mg/24 hr or higher, serum free light chain (sflc) 10 mg/dl or higher, and abnormal sflc ratio. * adequate hematologic, renal, and hepatic function * a negative pregnancy test (for females of childbearing potential). * patients must provide written informed consent. exclusion criteria: * other invasive malignancy within the past 3 years. * active cerebral/meningeal disease related to the underlying malignancy. * active grade 3 or higher infection. * known to be positive for hiv or known to have active hepatitis b or c. * previous allogeneic stem cell transplant. * idiopathic interstitial pneumonia or impaired diffusion capacity of the lung for carbon monoxide (dlco). * cerebrovascular or cardiovascular event, or congestive heart failure within the last 6 months. * females who are pregnant or breastfeeding.
multi-elemental imaging of lung tissues with libs (laser-induced breakdown spectroscopy)

Conditions: Interstitial Lung Disease; Sarcoidosis; Idiopathic Pulmonary Fibrosis

Summary: evaluate the feasibility of performing a multi-elemental imaging analysis of lung specimens from patients with ilds, with an technology named libs (laser induced-breakdown spectroscopy)

there is a major health problem due to the environmental and occupational related exposures to mineral particles, metals, and dust. the impact on health is considerable in terms of prevalence, morbidity and healthcare costs. pathologists rarely report the presence of a possible mineral or metal-related etiology in a specimen by lack of available and convenient technology. therefore, several respiratory diseases are considered idiopathic. interstitial lung disease (ild), also known as diffuse parenchymal lung disease (dpld) is a group of lung diseases affecting the interstitium (the tissue and space around the air sacs of the lungs). in france, 15.000 new cases of ild are diagnosed each year. ild may be classified according to the cause. idiopathic ild are ild of unknown causes. the most frequent idiopathic ild are sarcoidosis and idiopathic pulmonary fibrosis (ipf).these two diseases are the core topic of the present study since they may relate to important mineral or metal exposure. the overall goal of this medico-libs study is to evaluate the feasibility of using a laser-induced breakdown spectroscopy (libs)-based instrument to image(ie, identify, localize and possibly quantify) metals within selected human specimens with ilds.

Eligibility criteria:
inclusion criteria: * patient with ild * patient informed, and agreed to participate exclusion criteria: * patient opposed to participating in the study. * patient without available specimen. * patient under legal protection

Keywords: laser induced breakdown spectroscopy multi elemental imaging
the norwegian stroke in the young study ii

Conditions: Ischemic Stroke at a Young Age

Summary: nor-sys ii is designed for finding the cause of acute ischemic stroke lesions in young adults, age 15 to 49 years. risk factors, arterial wall changes by intima-media thickness and plaques and consequences of stroke are examined by standardized diagnostics.

nor-sys ii is as far as possible standardized concerning patients' history, ultrasound examination of pre-cerebral and femoral arteries, and standardized examinations performed by speech therapists, occupational therapists and physiotherapists. the ultrasound-protocol for carotid and femoral arteries is the same as previously performed in the nor-sys study. the methods have been published before.

Eligibility criteria:
inclusion criteria: * documented acute, arterial ischemic stroke * speaks norwegian fluently exclusion criteria: * post-traumatic and procedure related stroke * sinus venous thrombosis, sepsis and endocarditis * serious co-morbidity, such as advanced cancer with "end-of-life stroke". * patients mentally retarded or with severe psychiatric disease who do not accept the diagnosis and who would need sedation to perform clinical diagnostics.

Keywords: young ischemic stroke risk factors causes consequences
autologous fat infiltration versus general measures as treatment in radiodermatitis induced for radiotherapy in breast cancer patients

Conditions: Breast Cancer; Radio Dermatitis; Radiotherapy

Summary: radiodermatitis is a major problem in oncologic patients, fat grafts previously used for cosmetic procedures have been shown to have regenerative power due to their stem cell content. our purpose was to compare the clinical changes in the treatment of radiation dermatitis in breast cancer patients with the application of fat graft versus traditional therapy with general measures.a randomized controlled clinical trial was performed, 22 patients were recruited and randomly assigned to one of two groups: an intervention group that received an autologous fat graft and a control group that received treatment with general measures; a 6-week follow-up was performed to determine the presence and classification of radiodermatitis using the lent/soma scales, as well as biopsies. women were included, with a diagnosis of breast cancer, eastern cooperative oncology group 0 or 1, attended in our hospital during september 2023 to october 2024, older than 18 years, undergoing lumpectomy or mastectomy and in radiotherapy as part of the treatment scheme for breast cancer.


Eligibility criteria:
inclusion criteria: * patients older than 18 years with a confirmed diagnosis of common bile duct cyst by imaging studies and/or intraoperative findings. * patients who received surgical treatment at the institution during the study period. * clinical records with complete information for analysis. exclusion criteria: * patients who do not consent to their inclusion in the study or who for any physical or mental reason are unable to give their consent (patients with cognitive impairment, etc.). * pediatric patients (\<18 years). * incomplete clinical records or with loss of postoperative follow-up. * patients with diagnosis of other biliary pathology without evidence of common bile duct cyst.

Keywords: autologus fat filtration radiodermatitis breast cancer nanofat
scleral hydrops and intralabyrinthine schwannoma

Conditions: Hydrops Saccular

Summary: the symptoms of intralabyrinthine schwannomas (vertigo, deafness, instability, tinnitus) cut across the symptoms found in pressure pathologies involving the inner ear, particularly the endolymphatic hydrops. some publications have described dilatation of the membranous labyrinth (hydrops) in the presence of intralabyrinthine tumors. it would be interesting to measure the size of the saccule (structure of the membranous labyrinth) in the presence of an intralabyrinthine schwannoma, to evaluate if some of the symptoms presented by the patients could be explained by the concomitant presence of an endolymphatic hydrops (accessible to drug therapy - betahistine).


Eligibility criteria:
inclusion criteria * age\> 18, * subject having benefited from an exploration of internal auditory canals by mri in our service at chu de hautepierre between january 1, 2008 and october 1, 2017 * presence on the mri of the internal auditory ducts, including the realization of a high resolution fluid sequence of fiesta-c (exploitable) type, of an intralabyrinthine schwannoma, without extension to the internal auditory canal. * subject who has agreed to the use of medical data for the purposes of this research. criteria for non inclusion * refusal of the patient to participate in the study * absence of high resolution fluid sequence of fast imaging employing steady state acquisition (fiesta-c) * presence of movement artifacts interfering with the interpretation of the fiesta-c sequence * interior surgery of the inner ear or pontocerebellar angle, without preoperative imaging inflammatory or infectious pathology of the concomitant middle or inner ear * extension of schwannoma to the internal auditory canal * impossibility of giving the subject informed information (difficulty understanding the subject,) * subject under the protection of justice * subject under guardianship or curatorship

Keywords: hydrops sacculaire schwannoma intralabyrinth
antiretroviral switch from didanosine to tenofovir in hiv/hcv co-infected patients

Conditions: HIV; HIV Infections

Summary: the primary purpose of this study is to evaluate the impact of changing didanosine in an effective anti-hiv regimen to tenofovir on virologic suppression. we hypothesize that, in patients with maximal virologic suppression on a double class regimen (including two nrtis and an nnrti or a pi, boosted with rtv or not), a single drug substitution of didanosine for tenofovir will represent a viable strategy without any negative impact on the virologic efficacy of the regimen.

primary objective - to determine the impact of changing part of an effective haart regimen to tenofovir on maintenance of virologic suppression in hcv co-infected patients. secondary objective - to assess the safety and tolerability over 12 weeks in patients switched to tenofovir. research method - this will be a single arm observational study to include 30 subjects. patients requiring hcv treatment will be assessed and patients receiving didanosine will be clinically evaluated to determine an appropriate nrti drug switch. patients who are to switch the didanosine component of their regimen to tenofovir will be eligible to participate in the study and will be followed for a period of observation of up to 4 weeks. all patients will be receiving tenofovir as one capsule, once daily. the primary endpoint will be maintenance of virologic suppression between the baseline visit and week 12 in the overall study group. measures of adherence to haart, safety, tolerability and cd4 cell counts will also be obtained at each study visit, and will constitute secondary study endpoints.

Eligibility criteria:
inclusion criteria: 1. be age 19 or older; 2. have a confirmed diagnosis of hiv infection; 3. have a confirmed positive hcv rna pcr; 4. have two consecutive hiv rna levels \<50 copies/ml with the most recent within the past 3 months; 5. must not exhibit evidence of an acute illness, including an acute opportunistic infection; 6. must not have any evidence of grade 3-4 laboratory abnormalities; 7. must be able and willing to provide informed consent. exclusion criteria: 1. be receiving investigational drug within 30 days prior to beginning this study; 2. if female, be pregnant or breast-feeding; 3. in the opinion of the investigator, is unlikely to comply with the study protocol or is unsuitable for participation for any reason.

Keywords: tenofovir didanosine hiv hepatitis c virus infection treatment
fluid dairy products consumed before and within a pizza meal on glycemic response, food intake and satiety in children

Conditions: Diabetes Prevention; Obesity Prevention

Summary: the purpose of this study is to examine the effects of fluid dairy products on blood glucose and insulin, satiety and energy intake in normal weight and overweight/obese children in the age range of 9-14 y. experiment 1: the specific objective is to examine the effects of isocaloric and isovolumetric amounts of 2% m.f. milk, 1% m.f. chocolate milk, 1.5% m.f. yogurt drink, tropical punch and water consumed before and within a pizza meal 60 min later on appetite and food intake. experiment 2 will compare the effects of 2% m.f. milk and tropical punch consumed before and with a pizza meal 60 min later on food intake, blood glucose, and appetite hormone response.


Eligibility criteria:
inclusion criteria: * healthy * born at term exclusion criteria: * diabetes * medications * lactose-intolerance or allergies to milk * breakfast skippers and those on an energy restricted diet

Keywords: food intake appetite blood glucose insulin dairy milk
telepharmaceutical care diabetes trial

Conditions: Diabete Mellitus; Diabete Type 2; Telemedicine; Telehealth

Summary: the prevalence of diabetes mellitus (dm) in the world is currently around 9.3% of adults aged between 20 and 79 years, which corresponds to 463 million people living with dm, and about 80% of these people are found in developing countries. in brazil, fourth in the number of patients with type 2 diabetes mellitus (dm2) in the world, the prevalence of dm is around 12%, with a significant increase in the last three decades. non-adherence to dm treatment is known as a problem in the scenario and internationally, as it impairs the physiological response to the disease, increasing the direct and indirect cost of treatment. pharmaceutical care is a practice model characterized by the provision of pharmaceutical services that optimize treatment, improve the process of medicines used, and aim at their best use. with the calamity situation arising from the covid-19 pandemic created in the state of rio grande do sul, the pharmaceutical telecare service was implemented. dapagliflozin was recently incorporated into the brazilian public system for the treatment of type 2 dm. considering that there are no studies in brazil to date on the use, treatment adherence, and problems related to pharmacotherapy (prm) associated with dapagliflozin, and also considering that the guidance and monitoring of patients remotely have become more frequent and necessary, the purpose of this protocol is to describe a clinical trial that will evaluate the impact of a pharmaceutical telecare service in aspects related to treatment adherence, disease control, and costs, offered to people with dm2 using dapagliflozin. the hypothesis that will be tested is that pharmaceutical telecare can be as effective as standard care for type 2 diabetes and assess the associated costs related to teleconsultation in public health settings.


Eligibility criteria:
inclusion criteria: * people aged 18 years or older, with a previous diagnosis of type 2 diabetes mellitus and who take dapagliflozin at the special medicines pharmacy of the state of rio grande do sul, brazil, will be selected. in addition, it will be considered an inclusion criterion that the person is available to receive phone calls. exclusion criteria: * do not present a telephone record registered in the system; * be participating in another diabetes education program; * pregnancy; * severe cognitive problems; * communication difficulties; * presence of other injuries; * patients who are hospitalized at the time of recruitment will also be excluded from participation in this study.

Keywords: telehealth pharmaceutical care diabetes mellitus pharmaceutical services tele-interventions
evaluation of effectiveness and safety of abluminal biodegradable polymer sirolimus-eluting stent

Conditions: Coronary Artery Disease; Percutaneous Coronary Intervention

Summary: in real-world practice, the investigators plan to evaluate the effectiveness and safety of using the genoss (genoss des ii) stent, which has a biodegradable polymer only on the inner wall of the blood vessel, for patients(all-comers) with coronary artery disease who require percutaneous coronary intervention through stent insertion.

this study will enroll patients who underwent percutaneous coronary intervention using the genoss des stent. this study is a single-arm, registry, observational study, so it is not necessary to calculate the number of subjects, but the investigators plan to enroll approximately 1,000 patients at 7 institutions during the registration period.

Eligibility criteria:
inclusion criteria: 1. adults over 19 years of age 2. patients with typical symptoms or objective evidence of myocardial ischemia and eligible for coronary angioplasty. 3. severe coronary artery stenosis suitable for genoss stent insertion 4. patients who agree to the research protocol and clinical follow-up plan and give written informed consent in the consent form approved by the institutional review board/ethics committee of each research institution. exclusion criteria: 1. test subjects with known hypersensitivity or contraindications to the following drugs or substances: heparin, aspirin, clopidogrel, sirolimus, contrast medium (however, even subjects with hypersensitivity to contrast medium can be controlled by steroids and pheniramine) in this case, registration is possible, but if there is known anaphylaxis, it is excluded) 2. patients who also received other drug-eluting stents 3. if you have a disease with a remaining life expectancy of less than 1 year 4. pregnant or lactating women or women who may be pregnant 5. cases in which the patient was admitted to the hospital due to psychogenic shock and the likelihood of survival is medically expected to be low. 6. patients judged by researchers to be unsuitable for research
sling vs no sling after reverse total shoulder arthroplasty

Conditions: Shoulder Disease; Rotator Cuff Tear Arthropathy; Shoulder Osteoarthritis

Summary: this study involves patients who will be undergoing a reverse total shoulder replacement at duke university. 100 eligible will be randomly assigned into one of two groups, a sling or no sling group. patients in the sling group will wear a sling for three weeks after their surgery while the no sling group will only wear a sling three days after their surgery. patients will follow their doctors normal follow up visit schedule after surgery, with visits at 2 weeks, 6 weeks, 3 months, 6 months, 1 year, and 2 years.

the purpose of this study is to determine whether or not a sling is necessary after the nerve block has worn off postoperatively for patients undergoing reverse total shoulder arthroplasty. patients who are scheduled for a reverse total shoulder with the participating investigators will be approached for potential participation in the study. before the surgery, subjects will be randomly assigned to either the sling (control) group or the no-sling (investigational) group. the sling, or control, group will wear a sling through 3 weeks postoperatively. the no sling (investigational) group, will wear a sling either through 3 days postoperatively. following surgery, patients will be followed at their standard of care visits at 2 weeks, 6 weeks, 3 months, 6 months, 1 year, and 2 years after their surgical date. the investigators will collect data from these standard of care visits including pros (including but not limited to ases and sane), adverse events data, and physical exam data including range of motion. patients will be followed through their two-year visit and then taken off study.

Eligibility criteria:
inclusion criteria: * patient is scheduled to undergo a primary reverse shoulder arthroplasty procedure * patient voluntarily consents to participate in the study and has the mental and physical ability to participate in the study, fill out subjective questionnaires, return for follow-up visits, and comply with prescribed post-operative physical therapy * patient meets indications for primary reverse shoulder arthroplasty for the following diagnosis * rotator cuff arthropathy * glenohumeral arthritis * patient is between 18-100 years old * patient is english speaking exclusion criteria: * a history of ipsilateral shoulder arthroplasty * a history of shoulder septic arthritis * a history of a proximal humeral fracture * chronic locked dislocation * rheumatoid arthritis * tumors * axillary nerve damage * non-functioning deltoid muscle * glenoid vault deficiency precluding baseplate fixation * infection and neuropathic joints * known or suspected non-compliance, drug or alcohol abuse * patients incapable of judgement or under tutelage * inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, contraindication for imaging etc. * the subject is related to investigator as family members, employees, or other dependent persons