Kornimate/medical-research-clean huggingface dataset:
impact of a predetermined day 5 et vs. a predetermined day 6 et on clinical pregnancy rate after icsi treatment

Conditions: Infertility; Reproductive Issues

Summary: the aim of this prospective multicenter study is to investigate the influence of a predetermined embryo transfer on day 6 compared to a predetermined embryo transfer on day 5. the study population consists of the control group (predetermined embryo transfer on day 5) and the study group (predetermined embryo transfer on day 6). the primary endpoint is the clinical pregnancy rate (detection of a gestational sac) per embryo transfer and the secondary endpoint is the abortion rate per clinical pregnancy. the data from the multicenter study are obtained at three test centers (fertility center dortmund, fertility center essen and fertility center bad münder).

since a predetermined embryo transfer on day 5 cannot be performed in some centers on every day of the week (e.g. sunday), some ivf centers perform a predetermined embryo transfer on day 4 or day 6, respepectively. data for a predetermined embryo transfer on day 4 versus a predetermined embryo transfer on day 5 showed no significant differences regarding clinical pregnancy rates. however, since a day 6 transfer might offer advantages in assessing the development stage, the prolonged culture and transfer on day 6 transfer might be a very promising option. as of yet, there are no prospective studies in the current literature examining the equivalence of a predetermined embryo transfer on day 6 versus a predetermined embryo transfer on day 5. the aim of this prospective multicenter study is to investigate the influence of a predetermined embryo transfer on day 6 compared to a predetermined embryo transfer on day 5. the study population consists of the control group (predetermined embryo transfer on day 5) and the study group (predetermined embryo transfer on day 6). the primary endpoint is the clinical pregnancy rate (detection of a gestational sac) per embryo transfer and the secondary endpoint is the abortion rate per clinical pregnancy. the data from the multicenter study are obtained at three test centers (fertility center dortmund, fertility center essen and fertility center bad münder).

Eligibility criteria:
inclusion criteria: the patients to be included should be ≥18 years old. there is no upper age limit. only icsi treatments with a single embryo transfer (set) should be included. only the first cycle per patient should be evaluated. exclusion criteria: none

Keywords: icsi predetermined day 6 embryo transfer predetermined day 5 embryo transfer
development of a clinical screening, diagnostic and evaluation tool for patients with lower limb lymphedema: aim 2

Conditions: Lower Limb Lymphedema

Summary: lymphedema is a chronic, debilitating disorder characterized by abnormal tissue swelling, adipose deposition and tissue fibrosis, resulting from disruption, blockage, or genetic abnormalities of the lymphatic system. secondary lymphedema is an acquired lymphedema due to trauma, surgery, radiotherapy or infection among others resulting in a decreased transport capacity of the lymphatic system. this can be combined with an additional load on the lymphatic system due to obesity, venous hypertension or a wound, among others. advances in oncologic treatment have led to an ever-increasing number of cancer survivors over time. as a result, morbidities related to this treatment (such as secondary lymphedema) are likely to increase too. risk factors for the development of lll after treatment for (gynaecological) cancer are: pelvic and para-aortic lymphadenectomy, the number of pelvic lymph nodes removed, adjuvant radiotherapy, adjuvant chemotherapy, increasing bmi/ bmi ≥25 kg/m², lymphocyst formation, increasing age, increasing time since surgery and insufficient physical activity level. to the investigators knowledge, no evidence exists regarding which (combination of) measuring methods are most sensitive to detect early lymphedema at the lower limbs after the treatment of cancer. thresholds for identifying subclinical edema on one or both lower limbs are lacking. therefore the investigators want to develop a screening set for patients at risk for developing lll. which measurement method (and which criterion) shows the best diagnostic accuracy in screening patients at risk for lll after cancer treatment? and: what is the added value of combining different measurement methods in terms of diagnostic accuracy?


Eligibility criteria:
inclusion criteria: * patients with a diagnosis of skin melanoma (at the level of the lower limb, at least cancer stage 3), gynecological cancer, uro-genital cancer that will receive surgery (sentinel lymph node biopsy and/or (para-aortic/inguinal/pelvic) lymph node dissection) exclusion criteria: * pregnant participants * presence of chronic venous insufficiency c4, c5, c6; deep venous thrombosis; post-thrombotic syndrome * presence of skin infections of wounds at the level of the lower limbs at the moment of inclusion

Keywords: screening urogenital cancer gynaecological cancer skin cancer lymph node dissection
western sydney kidney injury biopsy study

Conditions: Kidney Injury

Summary: the investigators aim to develop a clinically validated, histological acute tubular injury (ati) scoring system to help improve diagnostic precision and predict clinical outcomes following ati. to use an unbiased, data-driven approach, correlating pathological features (including digital pathology), key signatures using spatial technologies (transcriptomics or proteinomics) with relevant clinical outcomes. spatial technologies (including spatial transcriptomics and spatial proteinomics) allow the use of 'precision pathology' to study the critical link between molecular characteristics to histological structure.

the study is an investigator-led, retrospective, observational cohort study. this study is intended to be in perpetuity and there will be regular reporting to the local hrec (western sydney local health district, wslhd) primary aim: the investigators aim to derive a clinically validated scoring system for acute kidney injury and iteratively improve its performance through machine learning algorithms over time. secondary aims: * derive a spatially resolved transcriptomic signature of acute kidney injury (aki) * derive accurate transcriptomic signatures aligned with key cell types in aki * derive unique gene signatures to differentiate different causes of aki all participants included in the study must be age ≥ 18 years old at time of enrolment and 1. had a kidney transplant at any time after the year 2000 2. kidney biopsy sample sent to westmead hospital for clinical interpretation 3. have information regarding kidney function available. this will include groups with 1. acute tubular injury (ati) only 2. ati concurrently diagnosed with any other pathology on biopsy 3. biopsies with no ati (negative control) collection of health related data will be through review of primary medical records to improve the diagnostic utility of kidney biopsies performed to evaluate the cause of aki. the investigators will also be requesting waiver of consent for access to histopathology slides and residual kidney tissue * histopathology slides, which were created and analysed as part of routine clinical care. * residual kidney tissue, either as paraffin blocks or fresh frozen tissue

Eligibility criteria:
inclusion criteria: 1. had a kidney biopsy (native kidney or transplant kidney included) after year 2000 2. kidney biopsy sample sent to westmead hospital for clinical interpretation exclusion criteria: 1. patients who have never had a kidney biopsy performed 2. biopsy sample not available at westmead hospital 3. no information on kidney function (serum creatinine or egfr)
study of investigational drug in osteoporosis (mk-0217-908)

Conditions: Postmenopausal Osteoporosis

Summary: the purpose of this study is to evaluate the efficacy and safety of an investigational drug in postmenopausal women with osteoporosis. the primary hypothesis of this study is that in postmenopausal women with osteoporosis, oral monthly ibandronate, at doses of 100 mg and 150 mg, does not achieve persistence in reduction of bone resorption throughout the monthly dosing interval, as demonstrated by a larger change in the serum carboxyterminal crosslinked telopeptide of type i collagen (ctx-i) log-transformed fraction from baseline four weeks post dose compared to one week post dose, during the third month of treatment, in the participants taking ibandronate than in the participants taking placebo.


Eligibility criteria:
inclusion criteria: -postmenopausal for at least 3 years, with osteoporosis at any of the following sites: \[bmd \> 2.0 standard deviations below young normal mean bone mass for the hip trochanter, pa lumbar spine (l1 to l4), total hip, or femoral neck based on the normative database provided by each individual manufacturer\]. * willing to take study-supplied calcium and vitamin d supplement (or equivalent) and to discontinue any non-study calcium supplements for run-in period and the duration of the study. exclusion criteria: -pregnant or lactating, or of childbearing potential. * participated in another therapeutic trial with an investigational compound within 30 days of randomization. * history of hypersensitivity to any component of ibandronate tablets or has hereditary problems of galactose intolerance, lapp lactase deficiency or glucose-galactose malabsorption. * an abnormality of the esophagus which delays esophageal emptying such as stricture or achalasia. * unable to stand or sit upright for at least 60 minutes once a month. * current use of illicit drugs, or history of drug or alcohol abuse within the past five years. * has any of the following: hypocalcemia; any severe malabsorption syndrome; moderate or severe hypertension which is uncontrolled; new onset angina or myocardial infarction within six months of entry into the study; evidence for impaired renal function; organ transplantation; or other significant end organ diseases (genitourinary, cardiovascular, endocrine, hepatic, psychiatric, renal, hematologic, or pulmonary). * history of or evidence of metabolic bone disease (other than postmenopausal bone loss). * clinical fracture in the past year. * is receiving or has received treatment prior to randomization which might influence bone turnover. * is receiving or expected to receive during the course of the study any medication (other than study medication) which might alter bone or calcium metabolism, including vitamin a in excess of 10,000 iu per day or vitamin d in excess of 5000 iu per day, calcitonin, phenytoin, heparin, or lithium.

Keywords: postmenopausal osteoporosis
percutaneous nerve evaluation with fluoroscopy versus without

Conditions: Overactive Bladder; Urinary Incontinence; Fecal Incontinence

Summary: the investigators propose a randomized control trial comparing the rate of implantation of the interstim device following percutaneous nerve evaluation (pne) performed with or without fluoroscopic guidance.

sacral nerve stimulation (sns) is a well-established treatment for refractory urinary urgency, frequency, retention and urge incontinence as well as fecal incontinence. patients whose symptoms are refractory to more conservative therapies such as behavioral modification and/or medications are candidates for sns. the interstim system consists of a permanent tined lead and implantable pulse generator (ipg) or battery that delivers the sacral neuromodulation. this device is typically implanted after patients have a successful response to a trial of sacral neuromodulation with a temporary lead and external battery. the temporary lead placement is known as a percutaneous nerve evaluation (pne) and is typically done in as an outpatient procedure using local anesthetic. it is standard practice to use fluoroscopy intraoperatively to confirm correct placement of the permanent lead. additionally, some physicians also use fluoroscopy to confirm correct placement of temporary lead during pne while others place the lead based on anatomical landmarks and expected elicited responses for s3 stimulation. the investigators propose a randomized control trial comparing the rate of implantation of the interstim device following (pne) performed with or without fluoroscopic guidance.

Eligibility criteria:
inclusion criteria: * women age \>18 * english speakers * patients with urinary urgency, frequency, or urge incontinence refractory to at least 1 other intervention who elect to undergo pne exclusion criteria: * patients in whom bilateral leads cannot be placed * pregnant women * prisoners * less than 18 years of age
multiparametric assessment of peripheral blood and tissue myeloid cells. phenotype for precision medicine in patients with sars-cov-2 infection

Conditions: COVID-19 Pneumonia

Summary: we hypothesise that patients with sars-cov-2 infection are characterized by progressive changes in distribution of distinct lung macrophages populations mediated by influx of circulating monocytes into the lungs . moreover, we also hypothesise that patients with higher rate of mertkpos alveolar macrophages in the lung lavage will have the lowest rate of lung complications and the best recovery outcome in terms of clinical outcome and need of assisted ventilation supporting the use of macrophage phenotyping as novel prognostic biomarker in patients with sars-cov-2 infection. finally, the definition of the transcriptomic signature of peripheral blood and tissue-derived myeloid cell subtypes will offer new therapeutic target of this uncurable newly discovered infection.


Eligibility criteria:
inclusion criteria: - patients with covid-19 pneumonia exclusion criteria: * other infections rather than covid-19 * patients with concomitant treatment with prednisone ≥10 mg daily * patients under therapy with immunosuppressants

Keywords: bronchoalveolar lavage fluid peripheral blood
a pilot study of mabthera (rituximab) evaluated by mri in patients with rheumatoid arthritis.

Conditions: Rheumatoid Arthritis

Summary: this single arm study will measure the effect of mabthera in combination with methotrexate on the progression of synovitis, the extent of bone marrow edema, and the number of erosions in the wrist and hand of patients with rheumatoid arthritis, using a new mri technique. patients will receive mabthera 1000mg i.v. on days 1 and 15, in combination with a stable dosage of 10-25mg/week methotrexate throughout the duration of the study. further courses of mabthera will be provided to eligible patients. mri will be performed 1-2 weeks before treatment initiation, and repeated 1 and 6 months after the first mabthera infusion. the anticipated time on study treatment is 1-2 years, and the target sample size is \<100 individuals.


Eligibility criteria:
inclusion criteria: * adult patients, 18-75 years of age; * rheumatoid arthritis for \>=3 months and \<=10 years; * inadequate response to methotrexate (12.5-25mg/week) for \>=3 months; * evidence of erosive disease and/or clinical synovitis in a signal joint. exclusion criteria: * autoimmune rheumatic diseases other than ra; * surgical operations on bones/joints in 12 weeks prior to baseline visit; * concomitant treatment with biologic agents; * previous treatment with more than one biologic agent approved for ra, or with cell-depleting therapies.
identification of genetic factors determining disease course in the new type of coronavirus infection, covid-19

Conditions: COVID-19; Sars-CoV2

Summary: the study aims to identify environmental factors and genetic (gene mutation and gene expression) changes, which influencing the course of the disease the new type of coronavirus infection covid-19 in patients nationwide in a multicenter study. at first in the study will be performed 200 patients, selected for a homogeneous groups on the basis of the patient's anamnestic data, genetic testing. following the interim analysis, based on the results, another 800 people are planned to involve.


Eligibility criteria:
inclusion criteria: * confirmed covid 19 infection exclusion criteria: * informed refusal
drug-drug interaction study between edp-514, itraconazole, carbamazepine, and quinidine in healthy subjects

Conditions: Hepatitis B

Summary: non-randomized, 3-part, open-label, drug-drug interaction (ddi) study to evaluate the effect of itraconazole, carbamazepine, or quinidine on the pk and safety of edp-514 in healthy adult subjects.


Eligibility criteria:
inclusion criteria: * an informed consent document signed and dated by the subject. * male and female subjects of any ethnic origin between the ages of 18 and 55 years, inclusive * female subjects who are heterosexually active and of childbearing potential must agree to use two effective methods of contraception from the date of screening until 30 days after the last dose of edp-514. * screening body mass index (bmi) of 18 to 30 kg/m2 with a minimum body weight of 50 kg. exclusion criteria: * clinically relevant evidence or history of illness or disease * pregnant or nursing females. * history of febrile illness within 7 days prior to the first dose of study drug or subjects with evidence of clinically significant active infection. * a positive urine drug screen at screening or day -1. * current tobacco smokers or use of tobacco products within 3 months prior to screening. * any condition possibly affecting drug absorption (e.g., gastrectomy, cholecystectomy). • clinically significant laboratory abnormalities at screening or day -1, as determined by the investigator (including but not limited to hypokalemia, hypocalcemia, or hypomagnesemia for part 3 participants). * history of regular alcohol consumption * participation in a clinical trial within 30 days prior to the first dose of study drug. for part 2 (carbamazepine) participants: * participants of asian ancestry, given association of carbamazepine and severe rash (stevens johnson syndrome \[sjs\] and toxic epidermal necrolysis \[ten\]) with hla-b 1502 in this population. * platelets, white blood cell count or hemoglobin below the lower limit of normal, due to reported incidence of agranulocytosis and aplastic anemia with carbamazepine.

Keywords: drug-drug interaction
hydrolyzed collagen in the reduction of osteoarticular pain and functional limitation

Conditions: Osteoarthritis

Summary: this randomised study evaluates the efficacy of an oral dietary supplement of hydrolyzed collagen in reducing pain and improving physical function in subjects with osteoarthritis.

in recent years, research efforts have focused on interventions such as collagen supplementation as an alternative treatment for pain and physical function in patients with osteoarthritis. hydrolyzed collagen (hc) is a mixture of collagen peptides with a molecular weight of less than 5,000 da. it is obtained from the gelatinization and subsequent enzymatic hydrolysis of native collagen from animal tissues rich in this protein. in this line, several studies show that hc is more easily absorbed enzymatically, has a higher bioavailability, is distributed to joint tissues, and has analgesic and anti-inflammatory properties, consistently showing symptom-relieving effects, thus improving joint function and reducing joint pain, as well as optimizing the patient's quality of life. in this randomized pilot study, the investigators aimed to evaluate the effect on pain and other parameters related to physical function of an oral dietary hc supplement composed of lemon flavoring, anhydrous citric acid (acidifier), calcium ascorbate (vitamin c), sucralose (sweetener) and stevia (sweetener). a 10.728 g dose provides 10 g of hc and 80 mg of vitamin c. each placebo packet contained sucralose (sweetener) and stevia (sweetener) in identical proportions to the active preparation. both the active and the placebo were manufactured by nutraresearch© sl (barcelona, spain) under good manufacturing practices (gmps).

Eligibility criteria:
inclusion criteria: * diagnosis of osteoarthritis according to the clinical and radiographic criteria of the american college of rheumatology. * pain score of at a minimum of 50 mm on a vas scale of 0-100 mm exclusion criteria: * presence of a previous cardiovascular event in the last 6 months. * history of liver or kidney disease. * presence of medical condition requiring chronic treatment with drugs or other substances. * excessive alcohol consumption (\> 20 g/day) or substance abuse. * presence of intolerance or hypersensitivity to the food supplement or to any of its components in isolation. * use of any intra-articular injection in the anatomical area under study in the last 6 months. * treatment with symptomatic slow-acting osteoarthritis drugs (sysadoa) in the last 3 months. * criteria listed in the clinical investigation guideline for medicinal products used in the treatment of osteoarthritis published by the european medicines agency of the european union in 2010 and radiographic osteoarthritis grade 4 according to the kellgren-lawrence classification system. * any condition that, in the opinion of the investigators, would disqualify the subject from participation in the study.

Keywords: hydrolyzed collagen osteoarticular pain functional limitation
study of glutamate and glutamine metabolism in burn patients receiving enteral or parenteral nutrition

Conditions: Burns

Summary: the purpose of the study is to understand how the body uses amino acids in burned patients during the time they cannot eat normally. amino acids occur naturally in the body and the food we eat. the body combines amino acids to make protein. it uses the proteins to do things such as heal wounds, fight infection, and provide energy. we are studying two ways of receiving nutrition: through a vein or through a tube. we are also studying two different types of food: with or without glutamine. the results of this study will be used to determine the best type and way to supply nutrients during a severe burn injury. we hope to learn how to help the body use nutrients more efficiently to better repair wounded tissues and recover earlier from injury.

we hypothesize that: 1. burn patients will experience an increased conversion of glutamine to glutamate and a decreased conversion of glutamate to glutamine as compared to healthy subjects. the net direction is from glutamine to glutamate in burn patients and would render glutamine as a conditionally essential amino acid. 2. because of the limited ability of liver to oxidize glutamate, it is possible that large doses of glutamine may cause increased gluconeogenesis in burn patients, thus aggravating the glucose homeostasis secondary to insulin resistance. 3. enterally and parenterally fed glutamine and glutamate have different metabolic fate in the splanchnic bed and peripheral regions, therefore the doses should be tailored according to the route of administration. this study, using stable isotope tracers, aims to track the metabolic fate of glutamine and glutamate in body with the goal of enhancing nutritional efficiency.

Eligibility criteria:
inclusion criteria: * one or more of the following: * 5% total body surface area thermal burn * inhalation injury * resting energy expenditure of \>15% of the predicted basal metabolic rate using harris-benedict. * receiving enteral or parental nutritional support exclusion criteria: * pre-existing: * thyroid disease * congestive heart failure (ejection fraction \<20%) * malignancy currently under treatment * medical conditions requiring glucocorticoid treatment * decision not to treat because of severity of injury * presence of anoxic brain injury with no expectation for recovery * self-inflicted thermal injury * ileus, gut paralysis, or facial injuries * no ng or og tube as part of their clinical care

Keywords: glutamine metabolic kinetics glutamate metabolic kinetics enteral nutrition parenteral nutrition burn injury stable isotopes