Kornimate/medical-research-clean huggingface dataset:
magnesium to reduce implantable cardioverter defibrillator (icd) shocks and improve patient's quality of life.

Conditions: Arrhythmia; Quality of Life; Hypomagnesemia

Summary: this study is being conducted to see if magnesium can reduce the number of shocks patients with icds experience and to see if magnesium supplementation improves patients quality of life.

not all icd shocks are for ventricular arrhythmias. some patients receive shocks when they have arrhythmias in the atria (top chambers of the heart). these are called inapproriate shocks, but the pain is similar to the pain patients feel with an appropriate shock (a shock for a ventricular arrhythmia). this study is being conducted to determine if taking magnesium can reduce the number of shocks patients with icds experience and to see if magnesium supplementation improves patients quality of life. magnesium's impact of the electrocardiogram (ecg) and intracellular magnesium concentrations will also be studied. comparison: magnesium compared to placebo in patients with icds to evaluate the number of icd shocks and patient perceived quality of life.

Eligibility criteria:
inclusion criteria:newly implanted icd or recent icd shock (within 6 months) - exclusion criteria:inability to swallow, a non-cardiac disease with a survival prognosis of less than 12 months, hypermagnesemia, a creatinine clearance less than 30ml/min, lactic acidosis or systemic acidosis syndrome, or previous intolerance to magnesium l-lactate. -

Keywords: implantable cardioverter defibrillator magnesium electrocardiogram ventricular arrhythmia
h-35 cl trauma cemented femoral stem

Conditions: Arthroplasty; Replacement; Hip

Summary: study design: monocentric, retrospective, observational and post-market clinical study. purpose: to demonstrate the safety and performance of cl trauma femoral stem. the eligible study population is represented by the entire population that underwent a hip replacement with cl trauma femoral stem from 2017 to 2023 at azienda ospedaliera di padova (it) in accordance with the indication for use of the product.


Eligibility criteria:
inclusion criteria: 1. male or female; 2. age \> 18 years old; 3. all patients must give written informed consent approved by the study site's institutional review board (irb)/ethical committee (ec); 4. adult patients in whom a decision has already been made to perform a partial or total hip arthroplasty with cl trauma femoral stem as per indication for use. the decision to implant cl trauma must be taken prior to, and independently from the decision to enroll the patient. this decision should be made in accordance with routine clinical practice at the study site concerned; 5. patients suffering from: non-inflammatory degenerative joint disease including osteoarthritis, avascular necrosis and dysplasia; or suffering from rheumatoid arthritis; or patients requiring treatment of femoral head and neck fractures; 6. patients able to comply with the protocol. exclusion criteria: 1. adult patients with any cl trauma femoral stem contraindication for use as reported in the current local instruction for use; 2. patients with active or any suspected infection (on the affected hip or systemic); 3. patients suffering from acute or chronic osteomyelitis; 4. patients with confirmed nerve or muscle lesion compromising hip joint function; 5. patients with vascular or nerve diseases affecting the concerned limb; 6. patients with poor bone stock (such as osteoporosis or extended previous revision surgery) compromising the stability of the implant; 7. patients with metabolic disorders which may impair fixation and stability of the implant; 8. any concomitant disease and dependence that might affect the implanted prosthesis; 9. patients with known incompatibility or allergy to the product materials, and/or metal hypersensitivity to implant materials; 10. patients currently participating in any other surgical intervention studies or pain management studies; 11. female patients who are pregnant, nursing or planning a pregnancy.

Keywords: hip replacement cemented stem
comparison of anterior corneal optical aberration induced by ck and hyperopic lasik

Conditions: Refractive Error

Summary: conductive keratoplasty (ck) had shown to be a safe and effective procedure for the treatment of low to moderate hypeopia. it had been approved by the u.s. food and drug administration (fda) to treat presbyope in early 2004. ck appeals to both surgeons and patients as it avoids the need for flap creation, the use of high intraocular pressure (iop), or tissue ablation. it utilizes "blended vision" rather than the true monovision used with laser in situ keratomileusis (lasik), which patients tolerate more readily. there is very little reported research about the induction of wavefront aberration by ck. the symptomatology of high order aberrations (hoa) and the way individual zernike functions were correlated with visual acuity, contrast sensitivity, visual symptoms. this study measured the hoa created by surgically induced myopic shift via ck and lasik in an effort to better understand the phenomena of regression, multifocality, pseudo-accommodation and monovision.

to investigate anterior corneal optical higher order aberration (hoa) induced by conductive keratoplasty (ck) and laser in situ keratomileusis (lasik). 69 eyes with hyperopia or presbyopia were enrolled. 47 eyes of 47 patients underwent ck procedure, 22 eyes underwent lasik. data were acquired preoperatively, and at 3 and 6 months postoperatively. the total root mean square (rms) of the hoa as well as the individual zernike polynomials of coma, trefoil, and spherical aberration were analyzed. in ck group, the high order rms showed significant elevation at 3 months, but it returned to near preoperative levels at 6 months postoperatively. trefoil (z33) is the exclusive zenike pattern to increase significantly following ck, peaking at 3 months and then decreasing back to near preoperative level at 6 months after ck. in the hyperopic lasik group, coma increased to a peak at 3 month postoperatively, and persisted at sixth month after lasik. spherical aberration decreased significantly at 3 months and persisted till the sixth postoperative month. there was significant correlation between δse and δspherical aberration showed in both groups. the hoa and main zernike polynomials pattern and their natural changes induced by ck is significantly different from that induced by lasik in the hyperopic corrected treatment. the amount of achieved hyperopic corrections induced by ck or lasik is not correlated to the change of hoa patterns such as coma and trefoil, but it is correlated to the change of spherical aberration.

Eligibility criteria:
inclusion criteria: * age of over 40 years old (yrs) * stable refraction * planned to induce a myopic shift exclusion criteria: * age of less than 40 years old (yrs) * significant systemic illnesses * congenital myopia, * media opacity uveitis * glaucoma * intraocular surgery refractive surgery * neurologic diseases * retinal disease

Keywords: conductive keratoplasty corneal optical aberrations hyperopic corrections lasik
prospective evaluation of biomarkers variability in knee prosthetic surgery

Conditions: Knee Osteoarthritis

Summary: bone quality is an important factor influencing the outcome of total knee replacement (tkr) surgery. therefore, assessing bone quality preoperatively could help the surgeon in the choice of the most appropriate prosthetic implant. the primary goal of this study is to measure serum and tissue levels of some proteins involved in bone remodelling.

aseptic implant loosening after tkr causes knee pain, reduces knee function and may require revision surgery. several proteins have been identified, which are involved in bone metabolism and remodelling; variations in serum levels of some of these proteins after tkr loosening have also been described. however, preoperative identification of risk factors for aseptic loosening remains a challenge. an observational study is conducted to evaluate how levels of the following serum biomarkers vary after tkr: * osteoprotegerin (opg) * receptor activator of nuclear factor kappa-b (rank) * receptor activator of nuclear factor kappa-b ligand (rank-l) * sclerostin * cathepsin k to avoid bias caused by inflammatory states, c reactive protein (crp), interleukin 1 (il-1), interleukin 6 (il-6), tumor necrosis factor α (tnf-α) levels and erythrocyte sedimentation rate (esr) will be measured. secondary goals are to evaluate the mrna expression of opg, rank-l, cathepsin k and sclerostin on tibial bone biopsies and to study if changes in serum biomarkers levels after surgery are associated with: * clinical outcomes * periprosthetic bone density * variation of two bone reabsorption markers, the postoperative change of which has already been described in details: type 1 collagen cross-linked c-terminal telopeptide (ctp1) and type 1 procollagen n-terminal telopeptide (p1np). one day before surgery, after having signed informed consent, patients will undergo a vertebral and femoral dual-energy x-ray absorptiometry (dexa) scan and blood samples will be collected. during surgery a tibial biopsy will be collected. between 4 and 7 days postoperatively and 3, 6 and 12 months after surgery patients will again undergo periprosthetic dexa scans and blood samples will be collected.

Eligibility criteria:
inclusion criteria: * age \> 40, \<80 * indication for tkr * surgical indication for pfc sigma®, posterior stabilized, mobile bearing tkr * patients signed written informed consent exclusion criteria: * age \> 80, \< 40 * tkr revision surgery * fixed knee deformities greater than 15° in varus, valgus, flexion or tibial slope. * knee ankylosis * paget's disease * hyperparathyroidism * patient treated with: bisphosphonates, strontium ranelate, selective estrogen receptor modulators for osteoporosis, calcitonin, denosumab. * informed consent not accepted * serious comorbidity * active infections * pregnant or breastfeeding women
comparison of coughing and active cycle of breathing technique to improve pulmonary functions in post-surgical patients

Conditions: Post Surgical

Summary: to find out the comparison of coughing and active cycle of breathing technique to improve pulmonary functions in post-surgical patients


Eligibility criteria:
inclusion criteria: * both male and female between the age of 18-50 years who reported post-surgical complications related to pulmonary will be selected in this study exclusion criteria: * if patient is unresponsive, psychologically disturbed and does not want to participate, teenagers will be excluded from this study
luminist: lung cancer molecular insights non interventional study

Conditions: NSCLC

Summary: the recent development of therapies targeting specific biomarkers mutations is changing the standards of care and prognosis of patients with advanced nsclc, but very few data are currently available on those emerging biomarkers. in addition, the correlation of biomarkers with patients' clinical outcomes in a standard of care setting is poorly understood. this study aims to address that need.

the luminist study will enrol patients who are ineligible for the select-1 (nct01933932) or select-2 (nct01750281)rcts. within this nis patients will be followed longitudinally for treatment information and outcomes. the final dataset will enable linkage at the individual patient level of the clinical information datasets collected within luminist to the exploratory biomarker data generated from samples collected as part of select-1 screening. this will enable the examination of various molecular markers in patients with v-ki-ras2 kirsten rat sarcoma viral oncogene homolog (kras) wild-type and some kras mutation positive (kras+) patients. the luminist study aims to enable the investigation of various molecular segments in nsclc, based on patient consent and where permitted by local legislation, some of which have not yet been discovered. the availability of a longitudinal dataset of clinical information linked to tumour samples will be a valuable tool to readily assess the clinical utility of potential new biomarkers. the determination of current standards of care and outcomes in future molecular segments of interest will provide valuable new insights to the scientific community.

Eligibility criteria:
inclusion criteria: 1. provision of informed consent from the patient or next-of-kin for deceased patient at study entry, where this is mandated by local regulations 2. female and male adults (according to each country regulations for age of majority) 3. patients who are not eligible or choose not to enter selumetinib select-1 or select-2 trials 4. patients with confirmed histological diagnosis of nsclc exclusion criteria: 1. involved in the planning and/or conduct of this study (applies to both az staff and/or staff at the study site)

Keywords: nsclc lung cancer select-1 select-2 selumetinib biomarker nis observational study disease registry clinical outcomes
brainagems - a comparative study of brain aging in healthy and patients with multiple sclerosis

Conditions: Multiple Sclerosis

Summary: the purpose of this study is to investigate new quantitative mri-sequences for assessment of age-specific data for the prediction of brain aging.

after being informed about the study, healthy controls and patients with multiple sclerosis giving written informed consent will undergo blood examination (for determination of the biological age using the publicly available r-package algorithm bioage), clinical examination (for motor, cognitive and psychological parameters) as well as an mri-investigation with chemical exchange saturation transfer (cest) and t1-relaxometry on a 7 tesla mri. data from the healthy controls will be used to set up a normative brain age data set, that could be used for example to train a model for brain age prediction.

Eligibility criteria:
inclusion criteria: informed consent signed by the subject * group 1: any healthy individual between 18 and 65 years of age * group 2: any individuals with any diagnosis of multiple sclerosis between 18 and 65 years of age and edss ≤6.0. exclusion criteria: * group 1 and 2: any other neurological disease except primary headaches: insufficient language skills in german or french; pregnancy, lactation, any contraindication for mri (active implants, passive ferromagnetic implants, passive non-ferromagnetic metallic implants \>4cm in the region covered by the active rf coils, large tattoos inside a region covered by the active radiofrequency (rf) coils, claustrophobia or suspected/known non-compliance), smoking within the last 10 years prior recruitment, any other drug consumption except moderate alcohol intake (less than a standard drink containing 10 grams of alcohol per day) or use of medical cannabis, any previous head trauma (with known/suspected intracranial consequences), body mass index (bmi) \>30, and any other chronic progressive disease. * specific criteria for group 1: the calculated biological age (bioage r package algorithm) differs by \> +/- 3 years from the chronological age. these patients will not be further invited for a study visit with clinical examination and mri. * specific criteria for group 2: edss \> 6.0 as this impacts physical testing; clinical relapse within the last 6 months

Keywords: brain aging multiple sclerosis neurodegeneration quantitative mri
study of panobinostat in combination with bortezomib and dexamethasone in japanese patients with relapsed/refractory multiple myeloma

Conditions: Relapse/Refractory Multiple Myeloma

Summary: the purpose of this study was to evaluate the efficacy and safety of panobinostat in combination with bortezomib and dexamethasone in japanese patients with relapsed/refractory multiple myeloma.


Eligibility criteria:
inclusion criteria: * patient had a previous diagnosis of multiple myeloma * patient required retreatment for multiple myeloma * patient had measurable m component in serum or urine at study screening exclusion criteria: * primary refractory disease (patients that never reached at least an minor response for over 60 days under any prior therapy) * patient who had been treated by bortezomib before, and did not reach at least a minor response under this therapy, or progressed under it or within 60 days of last dose * patient received prior treatment with dac inhibitors including panobinostat * patient had impaired cardiac function, or a prolonged qtc interval at screening ecg

Keywords: lbh589 panobinostat bortezomib dexamethasone phase ii bortezomib and dexamethasone japanese patients relapsed/refractory multiple myeloma panobinostat (pan)
echocardiography in nursing home

Conditions: Heart Diseases; Heart Failure; Heart Valve Diseases

Summary: the study seeks to explore the implementation characteristics (acceptability, appropriateness, feasibility, adoption, fidelity, penetration, implementation cost and sustainability) of systematic echocardiography in nursing homes and its impact on rates of heart failure flare-up and unscheduled hospitalization at 12 months among included nursing homes.

open-label cluster randomized type 1 hybrid trial, with 2 parallel arms: nursing homes will be randomized in the interventional (echocardiography by sonographer) or non-interventional arms (usual care). in the interventional arm echocardiography will be proposed to all residents of the nursing home at baseline. clinical management will be adapted to the result of echocardiography by the general practitioner, in accordance with the cardiologist. the main objective is to assess the impact at 12 months of the initial performance of a systematic simplified echocardiography on the rate of nursing home residents presenting with heart failure episode or cardiovascular pathology. the primary endpoint is the number of nursing home residents presenting a heart failure episode or an unscheduled hospitalization for heart failure or other cardiovascular pathologies at 12 months. thirty nursing homes and 1050 residents will be included overall

Eligibility criteria:
inclusion criteria : nursing homes residents with a life-expectancy estimated \> 1 year, and able to participate to the study, giving an oral consent exclusion criteria : * no accessible to echocardiography * closed unit (severe alzheimer disease...) * recent contagious disease such covid (\<15 days) * no consent to participate * no social security number

Keywords: echocardiography nursing home implementation heart failure
bioequivalence of metformin under fed conditions after administration of linagliptin / metformin fixed dose combination tablet and single tablets

Conditions: Healthy

Summary: to establish bioequivalence (be) under fed conditions between metformin in linagliptin/metformin fixed dose combination tablet and metformin reference product administered in free combination togther with linagliptin


Eligibility criteria:
inclusion criteria: 1. healthy male and female subjects exclusion criteria: 1. any relevant deviation from healthy conditions
effectiveness of interleukin-2 (il-2) plus anti-hiv therapy in hiv-positive patients

Conditions: HIV Infections

Summary: the purpose of this study is to find out if the immune systems of hiv-positive patients can be improved by treatment with anti-hiv medications plus interleukin-2 (il-2) in the early stages of hiv infection. il-2 is a protein found naturally in the blood that can help boost the immune system. hiv spreads throughout the body by invading cd4 cells, which are cells of the immune system that fight infection. doctors hope that adding il-2 to a current anti-hiv drug combination can help restore the cd4 cell count and the immune functions. this study will look at how the hiv virus acts during the early stages of hiv infection, how the immune system responds to hiv, and what impact early treatment with anti-hiv medications has on the course of hiv infection.

at the time of initial hiv infection, cd4 cells are susceptible to infection, and the virus infects many t cells during the first 4 to 6 weeks. many of these infected cells subsequently maintain the virus in a latent state. immune reconstitution with daily low-dose il-2 therapy is intended to correct or improve the deficiency in cd4 cells, while maintaining a high frequency of cd8+ hiv-specific ctl and increasing natural killer (nk) cells. after a year of haart plus il-2, it may be possible to discontinue haart while maintaining il-2 stimulatory therapy, and the immune reactivity repaired and stimulated by il-2 should be able to contain the virus and maintain latency. patients are randomized to add il-2 to their current haart regimen or simply to remain on their current haart regimen. il-2 therapy is initiated at month 3 of haart. il-2 is injected subcutaneously daily for 9 months, in addition to haart. after completion of this 1-year treatment period, patients are evaluated for discontinuation of haart. patients with a viral load below 50 copies/ml throughout haart plus il-2, a cd4 count of at least 500 cells/mm3, and no onset of opportunistic infections may have haart discontinued and il-2 continued as monotherapy for an additional 6 months. after completing 6 months of il-2 monotherapy, eligible patients may have il-2 therapy discontinued.

Eligibility criteria:
inclusion criteria patients may be eligible for this study if they: * hiv-infected. * viral load of 5,000 copies/ml or less within 3 months. * completed at least 3 months of anti-hiv medications. * have a refrigerator to store the needles for il-2 shots. exclusion criteria * glucocorticoids or other drugs that affect the immune system such as inf-alpha, g-csf, or gm-csf.

Keywords: interleukin-2 drug therapy, combination drug administration schedule viremia t-lymphocytes, cytotoxic anti-hiv agents treatment experienced
combination therapy for neovascular age related macular degeneration

Conditions: Macular Degeneration

Summary: exudative age related macular degeneration (armd) is most common cause of blindness in old population. it is clear that no single therapy addresses the multifactorial pathogenesis of the disease. recently, studies of intravitreal anti-vegf therapies such as pegaptanib and bevacizumab have shown the beneficial effect in visual acuity in the treatment of neovascular armd. however, the problem with these intravitreal injections is that therapy must be frequently administered for a prolonged but unknown period of time to maintain the benefit. prolonged, frequent injections may be associated with additional safety risk,lack of convenience and high treatment cost. intravitreal steroid injection with anti-inflammatory properties limits any further vegf upregulation initiated by the inflammation which has been known as one of the pathogenesis and causes of recurrence after the treatment of the neovascular armd. the researchers hypothesize that the combined treatment of intravitreal bevacizumab and triamcinolone acetonide may decrease the recurrence rate after the treatment and obviate the frequent intravitreal injections in the treatment of neovascular armd. in this study, the researchers will compare the recurrence rate of combined treatment of intravitreal bevacizumab and triamcinolone acetonide versus intravitreal bevacizumab alone in the treatment of neovascular armd.


Eligibility criteria:
inclusion criteria: * neovascular armd confirmed with 90+ noncontact lens biomicroscopy, fluorescein angiography, ocular coherence tomography exclusion criteria: * intractable systemic hypertension * recent myocardial infarct within 6 months at enrollment * recent cerebrovascular attack within 6 months

Keywords: age related macular degeneration intravitreal bevacizumab intravitreal triamcinolone acetonide neovascular age related macular degeneration