Kornimate/medical-research-clean huggingface dataset:
ischemic post-conditioning in acute ischemic stroke thrombectomy (protect-1b)

Conditions: Acute Ischemic Stroke; Reperfusion Injury

Summary: ischemic post-conditioning is a neuroprotective strategy attenuating reperfusion injury in animal stroke models. the investigators have conducted a 3 + 3 dose-escalation trial to demonstrate the safety and tolerability of ischemic post-conditioning incrementally for a longer duration of up to 5 min × 4 cycles in stroke patients undergoing mechanical thrombectomy. this study aims to assess the infarct volume after ischemic post-conditioning in patients with acute ischemic stroke who are treated with mechanical thrombectomy.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years; * acute ischemic stroke within 24 hours from stroke onset (or from time last known well) to groin puncture; * previous mrs ≤ 2; * baseline nihss ≥ 6; * baseline aspects ≥ 6; * with an occlusion of unilateral middle cerebral artery m1 segment/distal intracranial carotid artery; * successful recanalization (mtici ≥ 2b) after thrombectomy confirmed by dsa; * written informed consent provided by the patients or their legal relatives. exclusion criteria: * confirmed or clinically suspected cerebral vasculitis/fibromuscular dysplasia; * difficulty in reaching the designated position of the balloon used for ischemic post-conditioning; * stenting in the middle cerebral artery m1 segment/distal intracranial carotid artery during thrombectomy; * \> 2 times balloon dilations as rescue therapy due to angioplasty during thrombectomy; * moderate/severe residual stenosis (≥ 50%) in the offending artery after thrombectomy; * patients with contraindications to mri; * other conditions that the investigator considered inappropriate for inclusion.
coronary revascularization in patients on dialysis in china-retrospective registry

Conditions: Coronary Artery Disease; End Stage Renal Disease; Dialysis

Summary: coronary artery disease (cad) is the leading cause of death in end-stage renal disease (esrd) patients requiring dialysis. there are limited data on clinical characteristics, treatment strategies and outcomes in this special patient population in china. as a nationwide, observational, multicenter cohort study, this study consecutively included esrd patients on dialysis with significant cad at 30 tertiary care centers in 12 provinces in china from january 2015 to june 2021. patient data collected included demographics, comorbidities, cardiac history, cardiac function, location and severity of cad, procedural information, medications, and clinical events.


Eligibility criteria:
inclusion criteria: * 50% or greater stenosis in any of three main coronary arteries or left main coronary artery on visual assessment of the coronary angiogram * receive peritoneal dialysis or hemodialysis for more than 3 months exclusion criteria: -

Keywords: coronary artery disease end-stage renal disease cardiac catheterizations percutaneous coronary intervention coronary artery bypass grafting prognosis metabolic syndrome revascularization optimal medical therapy
study of efficacy and safety of s 95005 (tas-102) in patients with metastatic colorectal cancer who failed standard chemotherapies

Conditions: Metastatic Colorectal Cancer

Summary: the purpose of this study is to evaluate the efficacy of s 95005 in patients with metastatic colorectal cancer (mcrc) who are refractory or intolerant to standard chemotherapies in terms of progression-free survival rate at 2 months in the russian population.


Eligibility criteria:
inclusion criteria: * male or female aged ≥18 years of age * has definitive histologically or cytologically confirmed adenocarcinoma of the colon or rectum * has received at least 2 prior regimens of standard chemotherapies for metastatic colorectal cancer (including fluoropyrimidines, irinotecan and oxaliplatin and, if accessible, an anti-vegf monoclonal antibody and at least one of the anti-egfr monoclonal antibodies for ras wild-type patients (if ras mutation status was evaluated)) and was refractory or intolerant to those chemotherapies * has eastern cooperative group (ecog) performance status of 0 or 1 * has at least one measurable metastatic lesion(s) * has adequate organ function * female participants of childbearing potential and male participants with partners of childbearing potential must agree to use a highly effective method of birth control during the study and for 6 months after the discontinuation of study medication exclusion criteria: * pregnancy, breastfeeding * participation in another interventional study within 4 weeks prior to inclusion; participation in non-interventional registries or epidemiological studies is allowed * has previously received s95005 or history of allergic reaction attributed to compounds of similar composition to s95005 * has a serious illness or medical condition(s) as described in the protocol * has had certain other recent treatment e.g. major surgery, field radiation, anticancer therapy, within the specified time frames prior to inclusion * has unresolved toxicity of greater than or equal to common terminology criteria for adverse events (ctcae) grade 2 attributed to any prior therapies.

Keywords: metastatic colorectal cancer lonsurf s95005 russia
pilates training and low intensity shock wave therapy for post-prostatectomy stress incontinence

Conditions: Stress Incontinence, Male

Summary: 120 patients with urinary incontinence following radical prostatectomy would be randomly assigned to either 4 groups all receive conventional pelvic floor muscle exercises plus group a receive pilates exercises and low intensity extracorporeal shock wave therapy, group b receive low intensity extracorporeal shock wave therapy, group c receive pilates exercises and group d receive conventional pelvic floor muscle exercises. assessment at baseline, immediately after the intervention, to evaluate the degree of urinary incontinence and quality of life after three months from treatment.

120 patients with urinary incontinence following radical prostatectomy would be randomly assigned to either 4 groups all receive conventional pelvic floor muscle exercises plus group a receive pilates exercises and low intensity extracorporeal shock wave therapy, group b receive low intensity extracorporeal shock wave therapy, group c receive pilates exercises and group d receive conventional pelvic floor muscle exercises. assessment at baseline, immediately after the intervention, to evaluate the degree of urinary incontinence by urodynamic investigation system, severity index scale and cytometry and quality of life by the quality of life questionnaire iqol after three months from treatment.

Eligibility criteria:
inclusion criteria: * all patients diagnosed as urinary incontinence. * age between 40 -75 male patients or older. * all patients received the same medical treatment exclusion criteria: * adjuvant or neoadjuvant chemo-radiation therapy. * severe postoperative complications. * history of pelvic surgery, and diseases that could affect voiding function and limitations for the exercise program such as for patients with serious cardiovascular events or spinal or articular disease.
effects of a moisturizing product on dry eye and skin

Conditions: Dry Eye Syndromes

Summary: dry eye is a common syndrome associated with symptoms of dryness, burning, itching and grittiness of eyes. the objective of this study is to investigate the effects of a moisturizing product in liquid formula on symptoms and signs of dry eye and on skin around the eyes.


Eligibility criteria:
inclusion criteria: * dry eye symptoms osdi score 20 or higher * dryness, burning or foreign body sensation moderate or higher exclusion criteria: * severe eye diseases * known allergy to any of the ingredients of the product * laser surgery of eyes during the last year
study of a new anticoagulant drug in patients with atrial fibrillation

Conditions: Atrial Fibrillation

Summary: the primary purpose of this study (cln-504) is to determine the safety and develop a dosing regimen of an investigational anticoagulant drug (ati-5923) in patients with atrial fibrillation.

ati-5923 is a structural analog of warfarin that is being developed as an oral anticoagulant. it has a similar pharmacological profile to warfarin but was designed to provide more uniform and stable anticoagulation. ati-5923 is a selective, non-competitive inhibitor of vitamin k epoxide reductase. ati-5923 is metabolized by esterase to a single inactive metabolite and thus is expected to have less variable metabolism, drug-drug interactions and reduced instances of under/over coagulation, making the response safer and more predictable. the primary purpose of this study is to develop a dosing regimen and inr monitoring schedule that can be applied in an outpatient setting to safely and conveniently anticoagulate patients with atrial fibrillation to a therapeutic inr. patients with atrial fibrillation (af) were chosen for the study population of this trial because they require anticoagulation if they have risk factors for stroke.

Eligibility criteria:
inclusion criteria: * documented atrial fibrillation * candidate for anticoagulation or currently receiving warfarin at screening * males or females greater than 18 years of age * males or females with a chads2 score of 0 to 2 exclusion criteria: * contraindications to anticoagulation e.g., active bleeding * taking other anticoagulant or antiplatelet agents other than low-dose aspirin * history of myocardial infarction, acute coronary syndrome, or coronary revascularization procedure within the past 3 months prior to day 1 * history of laboratory values suggestive of anemia (i.e., hb \<10 gm/dl) * women of childbearing potential

Keywords: atrial fibrillation anticoagulation
outcomes of transrenal artery perfusion versus transrenal vein perfusion using lifeport for deceased donor kidney transplantation

Conditions: Kidney Transplantation; Organ Preservation

Summary: the main objective of this study is to compare the outcomes of transrenal artery perfusion versus transrenal vein perfusion using lifeport for deceased donor kidney transplantation. patients registered in the national dialysis and transplant registry awaiting deceased donor kidney transplantation were included. delayed graft function (dgf) or primary nonfunction (pnf) may occur after deceased donor kidney transplantation. compared with static cold storage, the application of lifeport can significantly reduce the incidence of dgf and pnf in deceased donor kidney transplantation. transrenal artery perfusion is currently the mainstream but confronts multiple renal arteries, resulted in prolonged cold ischemia time. transrenal vein perfusion is expected to be a solution. however, whether the clinical outcomes of transrenal vein perfusion is inferior to transrenal artery perfusion remains unknown. in this study, values of urine volume and creatinine, incidence and duration of dgf, and incidence of pnf within 1 week after surgery are recorded and compared between the transrenal artery perfusion group and the transrenal vein perfusion group. monthly egfr and creatinine values, the incidence of acute rejection within 1 year after transplantation and 1-year graft and patient survival are also recorded and compared.


Eligibility criteria:
inclusion criteria: 1. adult recipients older than 18 years; 2. patients diagnosed with end-stage renal diseases and volunteered to register in the transplant and dialysis registry of china awaiting for deceased donor kidney transplantation; 3. first single kidney transplantation; 4. the recipients can understand the purpose and risk of deceased kidney transplantation and sign informed consent; 5. ethics committee approved. exclusion criteria: 1. patients less than 18 years old, or more than 65 years old; 2. patients who receive multiple organ transplants; 3. diagnosed with malignancy or had a history of malignancy in the past 5 years; 4. non-kidney transplantation history.
exploratory study of the ercc-1 gene

Conditions: Colon Cancer; Rectal Cancer

Summary: this study is for patients with advanced or stage ii and iii colon or rectal cancer. the primary purpose of this research study is to determine if a particular protein in the patient's blood will change when they receive treatment with a drug called oxaliplatin, which is used to treat the colon or rectal cancer. this protein is called ercc-1. it is thought that the amount of this protein in the blood could influence the manner in which the patient responds to oxaliplatin.


Eligibility criteria:
inclusion criteria: * histologically confirmed diagnosis of colorectal cancer. * ecog performance status 0-2 (appendix a). * patient is a candidate for oxaliplatin based therapy either in the adjuvant or in the metastatic setting. * consent to donate 4 tubes of pbmc of 7 ml of blood each. * willing to consider additional post therapy tumor biopsy if applicable (refusal to consent is not an exclusion criteria). * adequate organ function as defined as: * neutrophil count \> 1500/μl * platelets \> 75,000/ μl * hemoglobin \> 8 g/dl * bilirubin \< 2.0 x upper limit of normal * creatinine \ 40 ml/mt * the patient must have signed a consent form approved by the albert einstein college of medicine cancer center cci and montefiore medical center irb exclusion criteria: * no other significant underlying medical condition that will, in the opinion of the principal investigator or designees, make administration of oxaliplatin unusually hazardous, such as significant hepatic, bone marrow and/or cardiac disease, requiring active medical treatment. * pregnant women or women of child bearing potential not practicing birth control or sexually active males unwilling to practice contraception during the study. * patients undergoing major surgical procedures (they will be delayed enrollment until complete recovery from their surgery - 4 wk for major or 2 wk from minor surgery). * patients with grade 2 neuropathy will not be eligible for the study. * the patient must not have received chemotherapy within 4 weeks of beginning oxaliplatin treatment. at least 6 weeks must elapse if prior therapy included mitomycin c or nitrosoureas. at least 2 weeks must have elapsed since the end of prior palliative radiation therapy.

Keywords: colorectal cancer oxaliplatin ercc-1
jak inhibitors for solid malignant tumor patients with immune checkpoint inhibitors-related dermatitis: a open-lable, single arm, phase iia trial

Conditions: Immune Checkpoint Inhibitors (ICI)-related Dermatitis

Summary: currently, the principal strategy for immune checkpoint inhibitors (ici)-related dermatitis include systemic use of corticosteroids, which can impair the efficacy of preceding icis treatment. janus kinase inhibitors (jaki) could be the optimal option for ici-related dermatitis, which can not only provide rapid relief for ici-related dermatitis but also potentially enhance the anti-tumor efficacy of icis. this is an open-lable, single arm, phase ii trial, aims to evaluate efficacy and safety of jak inhibitors for solid malignant tumor patients with ici-related dermatitis.


Eligibility criteria:
inclusion criteria: * patients receiving treatment with any of the food and drug administration (fda) approved monoclonal antibodies that block ctla-4, pd-1, pd-l1, or any combination. patients recommended to undergo skin biopsy due to a clinical diagnosis of ici-induced dermatitis as part of routine and standard clinical care are eligible. may have been treated with additional steroids or immunomodulators (one or more) prior to study entry (e.g. infliximab, mycophenolate mofetil, intravenous immunoglobulin), provided such immunomodulators are discontinued prior to first dose of study therapy. patients must be age 18 or older. patients diagnosed with solid malignant tumor. eastern cooperative oncology group (ecog) performance status \< 2. measurable disease as per recist 1.1 patients must be able to personally sign and date informed consent indicating that the patient has been informed of all pertinent aspects of the study are eligible. adequate organ and marrow function as defined below: white blood cell (wbc) ≥ 2.0 ×109/l. neutrophil (anc) ≥ 1.5 ×109/l. platelet (plt) ≥ 75 ×109/l. hemoglobin (hgb) ≥ 8.0 g/dl. ast and alt ≤ 3 x uln in subjects without hepatic metastases; ast and alt ≤ 5 x uln in subjects with hepatic metastases, if ast/alt elevation is not due to ici-induced hepatitis. total bilirubin ≤ 2 x uln not due to ici-hepatitis (except subjects with gilbert syndrome, where total bilirubin must be \< 3.0 mg/dl). exclusion criteria: * patients taking antibiotics or who plan to begin taking antibiotics known medical condition (e.g. a disease associated with chronic skin inflammation such as atopic dermatitis or psoriasis) that, in the investigator's opinion, would increase the risk associated with study participation or interfere with the interpretation of results not recovered to non-dermatologic =\< grade 1 toxicities related to any prior therapy pregnant woman patients with human immunodeficiency virus (hiv), hepatitis b, or c will be excluded from this study any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures (including compliance issues related to feasibility/logistics)

Keywords: immune checkpoint inhibitors (ici)-related dermatitis janus kinase inhibitors
an experimental medicine study to evaluate serum biomarkers of lipid metabolism

Conditions: Atherosclerosis

Summary: the purpose of this study is to validate novel assays for serum biomarkers of lipid metabolism (pcsk9 and ldl receptor) and to obtain information about how these biomarkers differ in subjects with normal or high cholesterol levels


Eligibility criteria:
inclusion criteria: * hypercholesterolemia * statin monotherapy exclusion criteria: * significant acute or chronic illness * secondary causes of hypercholesterolemia
a multidisciplinary intervention for weight loss

Conditions: Obesity

Summary: this is an open label study in which obese participants were treated with a restrictive hypo-caloric diet under hospitalization for a maximum period of 3 months in a metabolic rehabilitation unit. a multidisciplinary approach was used (combination of diet, physical exercise and psychotherapy)


Eligibility criteria:
inclusion criteria: * age \>= 18 * bmi \>= 30 * one or more comorbidities (type 2 diabetes mellitus, dyslipidemia, high blood pressure, hyperuricemia, and others) exclusion criteria: * active cancer * severe cognitive or functional impairments * severe behavioral disorders * known kidney failure (previous glomerular filtration rate \<30 ml/min) * known liver failure (child b or c)
hiv prevention preparedness study

Conditions: HIV Infections; HIV Seronegativity

Summary: the purpose of this study is to provide researchers with information that will help them prepare for a future study to test the efficacy of two anti-hiv vaginal gels. this study will also estimate how likely people living in certain areas are to become infected with hiv and other infections passed during sex.

this study is designed to prepare for the implementation of a second study, hptn 035: a phase ii/iii safety and effectiveness study of the vaginal microbicides buffergel and pro 2000/5 gel (p) for the prevention of hiv infection in women. hptn 035 requires an average hiv seroincidence rate of 5-6 percent among enrolled participants. the primary objective of the present study is to estimate the rates of hiv seroincidence among women targeted for inclusion in hptn 035. women will be enrolled in this study for 6 to 12 months. study visits will take place monthly. at each visit, participants will complete a medical/menstrual history and undergo pregnancy testing. each quarter, participants will undergo a structured interview about sexual practices and will receive hiv and std tests, education, and counseling. participants will also undergo a pelvic exam with wet mount testing for bacterial vaginosis, candidiasis, and trichomoniasis. colposcopic evaluations will be performed at selected sites. pap smears will be performed at sites with the capacity and expertise to prepare and interpret the smears and provide appropriate follow-up care to participants with abnormal results.

Eligibility criteria:
inclusion criteria: * sexually active (defined as having had vaginal intercourse at least once in the 3 months prior to screening). * hiv-uninfected at screening. * able and willing to provide adequate locator information for study retention purposes. exclusion criteria: * history of adverse reaction to latex. * non-therapeutic injection drug use in the 12 months prior to screening. * vaginal intercourse more than an average of 2 times per day in the 2 weeks prior to screening. * plans to travel away from the study site for more than 3 consecutive months in the next 12 months. * plans to relocate away from the study site in the next 12 months. * pregnancy or plans to become pregnant in the next 12 months. * pregnancy within 42 days prior to enrollment. * enrollment in any other study of a vaginally-applied product. * clinically apparent pelvic exam finding involving deep epithelial disruption. * diagnosis with a current std and/or other reproductive tract infection requiring treatment. * conditions that would preclude provision of informed consent, make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.

Keywords: incidence hiv seroprevalence vagina anti-infective agents administration, topical gels hiv seronegativity
the celljuvant study: a phase 3 immunogenicity and safety study of aqivc vaccine in adults aged 50 years and older

Conditions: Influenza, Human

Summary: this is a phase 3, randomized, parallel-group, comparator-controlled, observer-blind, multicenter study of immunogenicity and safety in approximately 7700 male and female adults aged 50 years and older (approximately equally split between two age groups: 50-64 years; 65 years and older), who are healthy or have stable comorbidities that increase their risk of complications from influenza infection. three lots of aqivc will be evaluated for consistency and pooled for the comparison with the 2 control vaccines. subjects will be randomly assigned to receive 1 of 3 lots of aqivc, qivr, or aqiv in a 1:1:1:2:2 ratio (for a 3:2:2 ratio for aqivc, qivr, and aqiv). the study will have a treatment period (day 1 to day 29) and a follow-up period (day 30 up to day 181); a subset of 770 subjects will be followed up up to day 365.


Eligibility criteria:
main inclusion criteria: * individuals, aged 50 years and older, who are healthy or have stable comorbidities that increase their risk of complications from influenza infection * individuals who can comply with all study procedures main exclusion criteria: * progressive, unstable, or uncontrolled clinical conditions * known hypersensitivity or allergy to any study vaccine component * known history of guillain-barré syndrome or other demyelinating disease * condition representing a contraindication to vaccination or blood draw * abnormal function of immune system due to known disorder or medication. * influenza vaccination within 180 days prior to informed consent.

Keywords: influenza vaccine mf59 adjuvant