Kornimate/medical-research-clean huggingface dataset:
a study of trastuzumab deruxtecan for patients with advanced her2-positive gastric or gastroesophageal junction adenocarcinoma who have received a prior trastuzumab-based regimen accompanied by a disease registry of patients treated with conventional therapies (prosperity)

Conditions: HER2-positive Advanced Gastric Cancer; HER2-positive Gastroesophageal Junction Adenocarcinoma

Summary: trastuzumab deruxtecan (t-dxd) as monotherapy is indicated for the treatment of adult patients with advanced her2-positive advanced gastric or gastroesophageal junction (gej) adenocarcinoma who have received a prior trastuzumab-based regimen. this study will assess the effectiveness of t-dxd, patient demographic and clinical characteristics, and treatment patterns in patients with advanced her2-positive advanced gastric or gej adenocarcinoma.

this non-interventional study will investigate the effectiveness of t-dxd, the patients demographic and clinical characteristics, treatment patterns including prophylactic medications and interventions for reduction of serious adverse events (saes), serious adverse drug reactions (adrs) and safety event of interest (seis), tolerability, and patient survey of t-dxd, in cases with advanced her2-positive gastric or gej adenocarcinoma receiving t-dxd as second line of treatment and beyond treatment option. patients will be treated according to the proposed indication statement in the summary of product characteristics (smpc). no investigational drug will be administered in this study. data on conventional therapy (including platinum-fluoropyrimidine doublet chemotherapy, nivolumab, ramucirumab-paclitaxel, ramucirumab monotherapy, taxane or irinotecan, and pembrolizumab monotherapy) will also be collected in a disease registry part of the study.

Eligibility criteria:
inclusion criteria: * male or female adult patient (age ≥ 18 years) with her2 + advanced gastric or gej adenocarcinoma who have received a prior trastuzumab based regimen * histological or cytological confirmed diagnosis of advanced her2 positive gastric cancer or gej * documented her2 + status (archival sample or recent sample prior 2l therapy) * decision to newly initiate monotherapy t-dxd or conventional therapies per smpc according to the physician's choice * written dated and signed informed consent (icf) to participate in the study exclusion criteria: * patients who at time of data collection for this study are participating in or have participated in an interventional study that remains blinded * pregnancy or breastfeeding no specific exclusion criteria are defined, as patients will be treated according to the proposed indication statements in the smpc.

Keywords: her2-positive advanced gastric cancer her2-positive gastroesophageal junction adenocarcinoma trastuzumab deruxtecan conventional therapy enhertu®
the use of aging biomarkers to predict adverse outcomes after cardiac surgery

Conditions: Coronary Artery Disease

Summary: cardiac surgery associated acute kidney injury (csa-aki) has been recognized as the second most common cause of hospital acquired aki. the development of csa-aki is independently associated with an increased risk of in-hospital death. there are currently no biomarkers that could identify patients at higher risk for aki and current risk predictor scores that are based on clinical and demographic information are inadequate. therefore, a diagnostic test for predicting aki risk in this clinical context would assist clinicians to optimize surgical strategy and postoperative care to prevent csa-aki occurrence and improve patient outcomes. the primary purpose of this study is to measure the association between baseline expression of senescence markers in blood using senescetest and the occurrence of csa-aki post surgery.


Eligibility criteria:
inclusion criteria: patients must fulfill all criteria to be eligible for this study: * adult patients (\>18 yo) undergoing non-emergency cardiac surgery using cardiopulmonary bypass (cabg, combined cabg/valve, or valve surgery). exclusion criteria: patients who fulfill any of the following criteria will be excluded: * emergency surgery. * off-pump coronary bypass grafting. * aortic aneurysm repair. * congenital heart disease repair. * heart transplant or lvad patient. * severe heart failure (lvef\<25%). * hemodynamic instability or requiring preoperative vasopressors or iabp. * pre-existing end-stage kidney disease (egfr\< 15 ml/min/1.73 m2) or renal transplantation. * presence of major active infection (chronic or acute, e.g. sepsis, hiv, pneumonia). * chronic liver disease /cirrhosis.

Keywords: coronary artery bypass graft surgery acute kidney injury renal failure biomarker
limb ischemic preconditioning for prevention of contrast media induced nephropathy in diabetic kidney patient

Conditions: Serum Cystatin C Before and After Coronary Angiogram; Serum Creatinine Before and After Coronary Angiogram

Summary: contrast media induced nephropathy (cin) is considered to be a serious complication in patient who underwent coronary angiogram (cag). the pathogenesis of cin does not well understood. the probable one is the contrast media makes the afferent vessel in glomeruli constrict and results in renal shut down. limb ischemic preconditioning, a procedure that makes muscles become ischemic and adapt themselves to produce some cytokines for signaling the vessel more dilated. after the reperfusion, these cytokines are getting back to systemic circulation and effect the afferent vessel in glomeruli to become more dilated and prevent cin.


Eligibility criteria:
inclusion criteria: * documented diabetic kidney disease * elective coronary angiogram * glomerular filtration rate \< 60 ml/min by cockroft-gault or modification of diet in renal disease or ckd-epi exclusion criteria: * refuse or reject to inform consented * hemodynamic compromise (heart failure, need for intraaortic balloon pump) * expose to drug or chemical substances potentially to be a nephrotoxic agent with in 1 mo (not include preexisting angiotensin converting enzyme inhibitor or angiotensin receptor blocker with stable serum creatinine) * documented or suspected of peripheral arterial disease, upper or lower limb * bleeding diathesis * contraindicated for coronary angiogram * currently on renal replacement therapy
supplementing intracytoplasmic sperm injection handling medium with cytochalasin b

Conditions: Infertility

Summary: vienna consensus has identified 10% damage rate after icsi as a competency value. despite the highest quality embryologists doing icsi, degeneration sometimes occurs due to oocyte factors such as the fragile membrane, etc. cytochalasin b serves to facilitate spindle or pronuclear transfer procedures helping to reduce the damage rate with no harm reported. using cytochalasin b during icsi could serve to rescue some oocytes from the degeneration allowing for more chances of viable zygotes,


Eligibility criteria:
inclusion criteria: * all icsi candidates patients exclusion criteria: * no exclusion
a study clbg and benzoyl peroxide gel 1%/5% to benzaclin® gel in the treatment of acne vulgaris

Conditions: Acne Vulgaris

Summary: this study is to evaluate the therapeutic equivalence and safety of clindamycin and benzoyl peroxide gel 1%/5% and benzaclin® (clindamycin 1%/benzoyl peroxide 5%) topical gel

the objectives of this study are to evaluate the therapeutic equivalence and safety of clindamycin and benzoyl peroxide gel 1%/5% (taro pharmaceuticals inc.) and benzaclin® (clindamycin 1%/benzoyl peroxide 5%) topical gel (sanofi aventis, us) in the treatment of acne vulgaris and to demonstrate the superiority of the efficacy of the test and reference products over the placebo control

Eligibility criteria:
inclusion criteria: 1. healthy male or nonpregnant female aged ≥ 12 and ≤ 40 years with a clinical diagnosis of acne vulgaris. 2. on the face, ≥ 25 non-inflammatory lesions (i.e., open and closed comedones) and ≥ 20 inflammatory lesions (i.e., papules and pustules) and ≤ 2 nodulocystic lesions (i.e., nodules and cysts). 3. investigator's global assessment (iga) of acne severity grade 2, 3, or 4 4. willing to refrain from use of all other topical acne medications or antibiotics during the 10week treatment period. 5. if female of childbearing potential, willing to use an acceptable form of birth control during the study. exclusion criteria 1. presence of any skin condition that would interfere with the diagnosis or assessment of acne vulgaris (e.g., on the face: rosacea, dermatitis, psoriasis, squamous cell carcinoma, eczema, acneform eruptions caused by medications, steroid acne, steroid folliculitis, or bacterial folliculitis). 2. excessive facial hair (e.g. beards, sideburns, moustaches, etc.) that would interfere with diagnosis or assessment of acne vulgaris. 3. history of hypersensitivity or allergy to benzoyl peroxide or clindamycin and/or any of the study medication ingredients. 4. use within 6 months prior to baseline of oral retinoids (e.g. accutane®) or therapeutic vitamin a supplements of greater than 10,000 units/day (multivitamins are allowed). 5. use for less than 3 months prior to baseline of estrogens or oral contraceptives; use of such therapy must remain constant throughout the study. 6. use on the face within 1 month prior to baseline or during the study of: 1) cryodestruction or chemodestruction, 2) dermabrasion, 3) photodynamic therapy, 4) acne surgery, 5) intralesional steroids, or 6) x-ray therapy. 7. use within 1 month prior to baseline of: 1) spironolactone, 2) systemic steroids, 3) systemic antibiotics, 4) systemic treatment for acne vulgaris (other than oral retinoids, which require a 6-month washout), or 5) systemic anti-inflammatory agents. 8. use within 2 weeks prior to baseline of: 1) topical steroids, 2) topical retinoids, 3) topical acne treatments including over-the-counter preparations, 4) topical anti-inflammatory agents, 5) medicated cleansers or 6) topical antibiotics.
nbi-1117568-scz3029: evaluation of nbi-1117568 in inpatient adults with schizophrenia

Conditions: Schizophrenia

Summary: the primary objective for this study is to evaluate the efficacy of nbi-1117568 compared with placebo on improving behavioral and psychological symptoms of schizophrenia in adults.


Eligibility criteria:
key inclusion criteria: * participant has a primary diagnosis of schizophrenia * participant is experiencing an acute exacerbation or relapse of symptoms and currently warrants hospitalization. * participants taking prohibited medications, including antipsychotics, must discontinue before study participation * participant is willing and able to remain in an inpatient setting for the study duration, follow instructions, and comply with the protocol requirements key exclusion criteria: * participant has known hypersensitivity to any component of the formulation of nbi-1117568. * participant has an unstable or poorly controlled medical condition or chronic disease * participant is considered by the investigator to be at imminent risk of suicide or injury to self or others * participant has a diagnosis of moderate or severe substance use disorder (with the exception of nicotine or caffeine dependence) within 6 months prior to screening * participant has a positive alcohol test or drug screen for disallowed substances * participants have a history of poor or suspected poor compliance in clinical research studies and/or in the investigator's opinion, the participant is not capable of adhering to the protocol requirements. note: other protocol-specified inclusion/exclusion criteria may apply.
clinical evaluation of web 0.017 device in intracranial aneurysms

Conditions: Brain Aneurysm

Summary: the study is an observational, european, multi-center, prospective assessment of the clinical utility of the 0.017 web aneurysm embolization system in subjects with intracranial aneurysms deemed appropriate for endovascular treatment.

all eligible subjects presenting to the participating centers will be considered for entry into the study. up to 160 evaluable subjects meeting the study entry criteria will be enrolled. subjects will be followed per institution's standard of care.

Eligibility criteria:
inclusion criteria: 1. subject must be ≥ 18 years of age and ≤80 years of age 2. subject must have an intracranial aneurysm (ia), 3. subject must sign and date ethics committee approved written informed consent prior to initiation of any clinical interventional procedures or when applicable, register the patient non opposition to the study data collection 4. for ruptured aneurysm, subject with hunt \& hess score ≤ iii exclusion criteria: 1. subject has an ia with characteristics unsuitable for endovascular treatment 2. subject's index ia was previously treated 3. subject has stroke-in-evolution within the prior 30 days 4. an additional aneurysm must be treated during the procedure
the effects of pharmacotherapy on brain mechanisms underlying cocaine dependence.

Conditions: Opioid-Related Disorders; Cocaine-Related Disorders

Summary: the overall aim of this project is to use an advanced brain imaging technique, pet, in order to monitor the progress of pharmacotherapy with modafinil or topiramate for cocaine dependence in methadone-maintained patients who use cocaine in addition. comparisons will be made within the cocaine dependent methadone maintained subjects, between the start and end of treatment, and between the two medications. this is the first systematic research study of pharmacological treatment for cocaine dependence in israel. this study is of major clinical use, with implications for the treatment of cocaine dependence in poly-drug abusers in israel. successful pharmacotherapy for cocaine dependence is expected in reduction in cue-induced subjective craving and in glucose metabolism in brain areas elicited by cocaine craving. metabolic activity in regions that are activated by craving should be correlated with dopamine drd2 receptor occupancy in all patients.

specific aims 1. to try to elucidate the brain mechanisms underlying cocaine dependence and craving in co-morbid cocaine-dependent patients. for this purpose we shall trigger craving for cocaine by exposure to a videotape showing cocaine use and then measure brain metabolic activity using positron emission tomography (pet) and \[18f\] fluorodeoxyglucose (fdg) 2. to evaluate dopamine binding in the brain in the early stage, and at the end of treatment. for this purpose the patients will undergo brain imaging of the dopamine receptor drd2 by using pet with \[11c\] raclopride. this is a well established procedure for quantifying the effects of drugs such as amphetamine and cocaine on the brain. 3. to investigate the association between subjective measures of craving for cocaine and the level of dopamine drd2 receptor occupancy in the brain.

Eligibility criteria:
inclusion criteria: * methadone-maintained cocaine-dependent patients use between 1g to 2g a day; 1 to 3 times a week exclusion criteria: * use more than 2g a day; 5 times a week to everyday * subjects who are diagnosed as suffering from psychotic illness according to dsm-iv (axis 1)22, or with a history of cns disease, a history of infection that might affect cns (hiv, syphilis, cytomegalovirus, herpes), or a history of head injury with loss of consciousness,pregnant women.

Keywords: imaging cocaine methadone craving pet fdg d2 modafinil topiramate
redox state in the course of chronic renal insufficiency and hemodialysis: implications in morbimortality

Conditions: Chronic Renal Insufficiency

Summary: the influence of hemodialysis on oxidative stress, endothelial activation, inflammation and on the redox state of lymphocytes should be clarified as well as the putative relationships between all these parameters.

up to now, no anti-oxydative treatment has been able to reduce the mortality of the patients with kidney failure. thus it is necessary to have a better knowledge of oxydative stress mechanisms in patients with kf in order to find more efficacious treatments. the influence of hemodialysis upon oxidative stress is not well known.

Eligibility criteria:
inclusion criteria: * 18 and 80 years old man or woman dialysing at least 3 times a week for at least 6 months and having no residual renal function * rate of haemoglobin \> 11 g / dl * clinically stable patient that is having had no considerable event (cardiovascular problem, infection, surgical operation) with the exception of angioplasty of fistula or prosthesis vascular, in the previous 3 months the entrance to the study * patient capable of understanding and of following the essay, in particular knowing how to read the note of information. exclusion criteria: * pregnant woman * treatment by corticoids or immunosuppresseurs * hemopathy sly * chronic cancer or infection in evolution * cardiovascular event (infarct, unstable angor, coronary bypasses, confusions of the rhythm, avc, amputation) or infectious (blood-poisoning, pneumopathie, meningitis) or surgical operation in the previous 3 months the inclusion in the study.

Keywords: redox state in the course of chronic renal insufficiency and hemodialysis.
validation of icg-99mtc-nanoscan as hybrid tracer for sentinel node biopsy

Conditions: Penile Cancer; Melanoma; Oral Cancer

Summary: 99mtc-nanocolloid, the world wide used hybrid tracer for dynamic sentinel node biopsy, has recently been replaced with 99mtc-nanoscan. the hybrid form (icg-99mtc-nanoscan) has not yet been validated, to show the similarity between the lymphatic drainage pattern between icg-99mtc-nanoscan and 99mtc-nanoscan.

the investigators want to set up this study in analogy with the comparison study which was conducted before the introduction of icg-99mtc-nanocolloid (99mtc-nanocoll vs. icg-99mtc-nanocoll (nl26699.031.09 -n09drf). in particular, the investigators want to validate that the hybrid icg-99m tc-nanoscan shows the same preoperative gland involvement on preoperative lymphoscintigraphy and that the intraoperative signal intensities remain the same. all this to maintain the level of current care.

Eligibility criteria:
inclusion criteria: * patient who will undergo a sentinel node procedure in routine care. * patients \> 18 years; * patients presenting with: * a primary cutaneous melanoma of head/neck or upper part of the trunk or extremities; * or patients presenting with a primary oral cavity malignancy t1-2n0 * or patients with primary penile cancer * patients with clinical n0 stage; * patients scheduled for a sentinel node biopsy prior to (re-)excision of the primary lesion; * patients in which icg-99mtc-nanoscan would be used in routine care or a research setting exclusion criteria: * patients with known allergy to patent blue dye or nanocolloid; * patients who are pregnant or breast-feeding mothers; * history of hypersensitivity reactions to products containing human serum albumin; * history of iodine allergy * hyperthyroid or thyroidal adenoma * kidney insufficiency * incapacity or unwillingness of participant to give written informed consent;

Keywords: fluorescence radioactivity indocyanine green clinical node negative patients surgical staging
study is designed to assess the safety and tolerability of azd4547 at increasing doses in patients with advanced tumours

Conditions: Cancer; Advanced Solid Malignancies

Summary: this study is primarily designed to assess the safety and tolerability of azd4547 at increasing doses in patients with advanced solid malignancies and for whom no standard medication options are available. it also assesses the blood levels and action of azd4547 in the body over a period of time.


Eligibility criteria:
inclusion criteria: * minimum life expectancy of 12 weeks * the presence of a solid, malignant tumour that is resistance to standard therapies or for which no standard therapies exist * in the expansion for the study patients must have a tumour at least 1cm in size that can be measure using a ct or mri scan, and provide a tumour sample to the sponsor company for testing of fgfr1 and/or 2 amplification * expansion, 5 groups of advanced cancer * solid tumours,fgfr1 and/or fgfr2 gene amplified * squamous nsclc, fgfr1 gene low \& high amplified * gastric adenocarcinoma, including the lower oesophagus/gastro-oesophageal junction, fgfr2 gene low \& high amplified * aged at least 25 years exclusion criteria: * treatment with any other chemotherapy, immunotherapy or anticancer agents within 3 weeks before the first dose of study * an inability to be able to take the study medication * a bad reaction to azd4547 or any drugs similar to it in structure or class.

Keywords: cancer tumour advanced solid malignancies fgfr squamous nsclc gastric adenocarcinoma
pilot study of rhbmp-2/bcp in patients with spinal degeneration with instability requiring surgical fusion

Conditions: Degenerative Disc Disease

Summary: this study is designed to generate data relating to patient safety, bone generating activity associated with the use of the rhbmp-2/bcp device as compared to autograft and to evaluate the feasibility of conducting a larger clinical trial in a patient population requiring spinal fusion.


Eligibility criteria:
inclusion criteria: * subject has radiographically documented spinal degeneration with instability as documented by the presence of translation \>= 4mm or angulation \>= 5°. * subject has intractable back pain which does not respond to conservative treatment and in the investigator's opinion, requires surgical spinal fusion. * subject's pain is predominantly associated with the back. * subject has only one level involvement at l3-l4, l4-l5, or l5-s1. * subject is 18 years of age or greater at the time consent is given to participate in the study. * subject is willing to comply with the study plan and sign the informed consent. * subject is male or a non-pregnant, non-nursing female. all females of child-bearing age must agree to use adequate contraception for a period of no less than 16 weeks following surgery. exclusion criteria: * subject has primary spinal diagnosis of a disorder other than spinal degeneration with instability at the involved surgical level. * subject has spinal stenosis or condition which requires a full laminectomy procedure. * subject has had a previous fusion, discectomy or laminectomy procedure at l3-l4, l4-l5 or l5-s1. * subject has received drugs which may interfere with bone metabolism within two weeks prior to the planned date of spinal fusion surgery (e.g., steroids, methotrexate) or has a condition which requires postoperative medications that interfere with fusion (e.g., steroids, nonsteroidal antiinflammatory drugs, or methotrexate). * subject has overt or active infection near the operative spinal region. * subject has active systemic infection. * subject has history of autoimmune disease (systemic lupus erythematosus or dermatomyositis). * subject's history includes hypersensitivity to protein pharmaceuticals (monoclonal antibodies or gamma globulins). * subject has received treatment with an investigational therapy within 28 days prior to implantation surgery or such treatment is planned during the 16 weeks following rhbmp-2/bcp implantation. * the subject requires electrical bone growth stimulation, allograft, or bone substitute as part of treatment. * subject has history of endocrine or metabolic disorder known to affect osteogenesis (e.g. paget's disease, renal osteodystrophy, ehlers danlos syndrome, or osteogenesis imperfecta). * subject has a known diagnosis of diabetes which requires treatment with medication. * subject has received previous radiation therapy at the site to be fused. * subject is unwilling to return for required follow-up visits. * subject is a prisoner. * subject has insufficient bone mass which precludes surgery (e.g., severe osteopenia or osteoporosis).

Keywords: spinal degeneration