Kornimate/medical-research-clean huggingface dataset:
safety and efficacy of a new treatment in combination with laser for diabetic macular edema

Conditions: Diabetic Macular Edema

Summary: this study will evaluate the safety and efficacy of the intravitreal implant of dexamethasone with laser treatment vs. laser treatment alone in patients with diabetic macular edema.


Eligibility criteria:
inclusion criteria: * 18 years of age or older with diabetic macular edema * decrease in visual acuity in at least one eye as a result of macular edema (20/50 or worse) * visual acuity in other eye no worse than 20/200 exclusion criteria: * known anticipated need for ocular surgery within next 12 months * history of glaucoma or current high eye pressure requiring more than 1 medication * uncontrolled systemic disease * known steroid-responder * use of systemic steroids - use of warfarin/heparin
dimethyldiguanide combined with aromatase inhibitor (ai) in metastatic breast cancer

Conditions: Metastatic Breast Cancer

Summary: the addition of dimethyldiguanide might increase the efficacy of ai treatment in metastatic breast cancer.

the addition of dimethyldiguanide might increase the efficacy of ai in patients with metastatic breast cancer after the failure of the first line endocrine therapy.

Eligibility criteria:
inclusion criteria: * postmenopausal hr positive breast cancer patients; * inoperable locally advanced or metastatic breast cancer patients; * candidate for endocrine therapy; * ecog equal to or less than 1; * adequate bone marrow function(hb\>=90g/l, wbc \>=3.5×10\^9/l,anc\>=1.5×10\^9/l, plt\>=80×10\^9/l; adequate renal function(ccr\<=uln);adequate liver function(alt,ast,akp\<=2.5\*uln,or \<=5\*uln if liver metastases) * life expectancy \>=12weeks; * no severe history disease of liver,heart,lung or kidney; * written informed consent form; exclusion criteria: * her-2 overexpression; * patients who has visceral endocrisis；
genotyping analysis of acute lymphoblastic leukemia

Conditions: Acute Lymphoblastic Leukemia; Adult

Summary: identification of alterations potentially involved in the complex mechanisms of leukemogenesis and at the identification and validation of novel biological factors which may serve as predictors of drug-response and drug-resistance or which may be suitable for targeted therapy.

the investigators will use several approach to identify common genetic variations: single-nucleotide polymorphisms (snps), genomic insertions and deletions, and genetic copy number variations (cnvs), interchromosomal translocations, loss of heterozygosity (loh), and uniparental disomy (upd), epigenetic changes, such as silencing of gene expression via dna hypermethylation, that can also influence drug effects, and aberrant methylation of cpg islands is a common feature of cancer cells. over the years, methods of cytogenetic analysis evolved and became part of routine laboratory testing, providing valuable diagnostic and prognostic information in hematologic disorders. the recently developed single nucleotide polymorphism (snp) arrays offer the ability to define simultaneously the copy number changes and loss of heterozygosity (loh) events occurring in a tumor, at high resolution and throughout the genome. in addition to information on copy number changes, snp arrays allow us to investigate the impact of a high number of snps on drug response and toxicity this molecular integrated approach will lead to the identification of alterations potentially involved in the complex mechanisms of leukemogenesis and at the identification and validation of novel biological factors which may serve as predictors of drug-response and drug-resistance or which may be suitable for targeted therapy.

Eligibility criteria:
inclusion criteria: * acute lymphoblastic leukemia of any subtype or lymphoid blast crisis chronic myeloid leukemia * age \> 18 years * available data set of clinical data for review (demographics including ethnicity, stage of disease, concise treatment history, cytogenetic reports, and molecular results if available as routinely performed during diagnosis procedures) inclusion criteria: * no written informed consent * no dna samples available

Keywords: pharmacogenomics genotyping
synchronized intermittent mechanical ventilation versus open lung ventilation with spontaneous respiration

Conditions: Trauma

Summary: the purpose of this study is to collect data on patients who are on breathing machines (ventilators) in the trauma surgical intensive care unit (tsicu). this data may help us to determine if one form of assisted breathing is better than another. the two forms of assisted breathing being compared in this study are called bivent and simv. (7) bivent and simv are both delivered by a ventilator but differ in how they assist breathing. simv is an older form of mechanical breathing that blows air into the lungs to inflate the lungs. bivent is a newer form of mechanical ventilation that permits the patient to pull air into the lungs as we normally do. both bivent and simv are currently being used on a regular basis in the tsicu. the investigators hope that this study will determine if one method of assisted breathing is better than another in preventing complications associated with mechanically assisted breathing.

solv hypothesis: a prospective, randomized trial directly comparing open lung ventilation (olv) with spontaneous breathing (sb) utilizing bivent on the maquet servo-i versus synchronized intermittent mechanical ventilation (simv) will be conducted in the trauma-surgical intensive care unit at the university hospital (tsicu). both olv-sb and simv protocols have been designed according to lung protective strategies. the primary goal of the solv trial is to see determine if the early application of open lung ventilation will less ventilator days. in addition, several secondary endpoints will be evaluated. it is not anticipated that this study will be powered to show a mortality difference.

Eligibility criteria:
inclusion criteria: * \>/=18 years of age, iss \>/=25, on ventilator for more than 48 hours exclusion criteria: * less than 18 years of age, die or come off ventilator in less than 48 hours

Keywords: ventilation ards ali trauma trauma patients with iss > 25
combination treatment using capravirine (ag1549), nelfinavir, and two nucleoside reverse transcriptase inhibitors in hiv patients who failed initial combination therapy

Conditions: HIV Infections

Summary: the purpose of this study is to look at the effectiveness of an anti-hiv drug combination that adds capravirine in patients who have failed their first drug combination treatment.

\[note: as of 2/28/2001, due to toxicity studies and concern for safety, changes in the methodology were implemented and patients need to sign new informed consents. the study is unblinded. group 1 receives ag1549; group 2 receives an ag1549 placebo. patients who are taking capravirine and who currently have viral loads below 400 copies/ml may continue to take capravirine at 1400 mg twice daily. capravirine will be discontinued in patients with viral loads greater than 400 copies/ml at their last visit and they will be switched to new therapies or continue with their background therapies as deemed appropriate by the investigators.\] both groups also receive nelfinavir mesylate and 2 nrtis. all patients receive the same dose of nelfinavir mesylate. the nrtis are selected at the investigator's discretion provided the patient has not previously received the chosen nrtis. patients have regular physical examinations. blood samples are collected regularly and at 1 month post-treatment to determine plasma hiv rna, pharmacokinetics, and cd4 and cd8 counts. patients who complete 24 weeks of treatment will have the option to continue treatment for an additional 24 weeks or end participation.

Eligibility criteria:
inclusion criteria patients may be eligible for this trial if they: * are hiv-positive. * have a cd4 cell count more than 50/mm3. * are at least 18 years old. * have adequate blood, kidney, and liver functions. * are currently taking an anti-hiv drug combination of an nnrti plus 1 or more nrtis for more than 28 days and are failing that combination. exclusion criteria patients will not be eligible for this trial if they: * have had any protease inhibitor or capravirine treatment. * have been given any drug that interferes with their immune system or with the study drugs within 28 days of study entry. * have had radiation therapy within 28 days of study entry.

Keywords: hiv-1 drug therapy, combination hiv protease inhibitors rna, viral reverse transcriptase inhibitors anti-hiv agents viral load nelfinavir
hypertonic saline solution in heart failure

Conditions: Heart Failure; Renal Failure; Hyponatremia

Summary: patients with decompensated heart failure have high rates of mortality and morbidity despite recent improvements in diagnosis and treatment. some aspects of their presentation such as renal failure, hyponatremia and congestive phenomena have received special attention, as they are associated with worse prognosis. the infusion of hypertonic saline solution has been tested in different conditions of cardiovascular collapse. current evidence indicates that the infusion of hypertonic solution in heart failure patients can provide clinical and haemodynamic improvement. the investigators are testing the hypothesis that the infusion of hypertonic solution in association with diuretics may prevent the occurrence of renal dysfunction in patients with decompensated heart failure.


Eligibility criteria:
inclusion criteria: * age over 18 years old * heart failure according to framingham criteria * episode of acute decompensation,with need of in-hospital treatment * presence of congestive phenomena exclusion criteria: * patient denial * left-ventricle ejection fraction over 0,4, as measure by transthoracic echocardiography * rheumatic disease * restrictive cardiomyopathy * alcohol abuse * chronic obstructive pulmonary disease * cancer * pulmonary embolism during the last 6 months * surgical procedures or acute illness during the last 30 days * chronic or acute infection * any other circumstance that may hamper patient prognosis for the next 6 months * serum creatine over 3.0mg/dl * serum potassium over 5.5 meqs/l * any specific condition associated to the acute episode of decompensation, such as new onset cardiac arrhythmias, heart ischemia, infection, etc.

Keywords: heart failure renal failure hyponatremia
preventive catheter ablation for ventricular arrhythmias in patients with end-stage heart failure

Conditions: Heart Failure; Arrhythmia, Ventricular; Cardiomyopathy Ischemic; Catheter Ablation; Heart Transplantation; Left Ventricular Assist Device

Summary: castle-vt is a randomized evaluation of prophylactic ablative treatment of arrhythmogenic ventricular scar in patients referred for htx evaluation and diagnosed with icm. ablation will be performed with the use of a substrate-based approach in which the myocardial scar is mapped and ablated while the heart remains predominantly in sinus rhythm. the primary end point is the composite of all-cause mortality, worsening of hf requiring prioritized transplantation or lvad implantation. the main secondary study end points are all-cause mortality, cardiovascular mortality, incidence of implantable cardioverter-defibrillator (icd) therapy, hospitalizations, quality of life, time to first icd therapy, number of device-detected ventricular tachycardia/ventricular fibrillation episodes, lv function, and exercise tolerance. castle-vt will randomize 160 patients with a follow up period of 2 years.


Eligibility criteria:
inclusion criteria: 1. ischemic cardiomyopathy with left ventricular ejection fraction ≤ 35% (measured in the last 6 weeks prior to enrollment) 2. eligible for heart transplantation due to end-stage heart failure 3. nyha class ≥ iii 4. impaired functional capacity or inability to exercise 5. indication for icd therapy due to primary prevention 6. implanted icd or icd implantation within 3 months after randomization 7. the patient is willing and able to comply with the protocol and has provided written informed consent 8. age ≥ 18 years exclusion criteria: 1. previous catheter ablation for ventricular arrhythmias 2. previous appropriate icd-therapy for ventricular arrhythmias 3. acute coronary syndrome, cardiac surgery, angioplasty, or cerebrovascular accident within 4 weeks prior to enrollment 4. untreated hypothyroidism or hyperthyroidism 5. woman currently pregnant, breastfeeding, or not using reliable contraceptive measures during fertility age 6. mental or physical inability to participate in the study 7. listed as "high urgent" for heart transplantation 8. cardiac assist device implanted 9. planned cardiovascular intervention 10. life expectancy ≤ 12 month 11. uncontrolled hypertension 12. requirement for dialysis due to end-stage renal failure
potential role of water-soluble ubiquinol in complementary therapy for pediatric dilated cardiomyopathy

Conditions: Pediatric Dilated Cardiomyopathy

Summary: pediatric dilated cardiomyopathy (pdcm) is the most common form fond in children. water-soluble coenzyme q10 (ubiquinol) is better absorbed than lipid-soluble coenzyme q10 (ubiquinone) and is directly involved in the antioxidant cycle. because coenzyme q10 has shown significant health benefits in adult patients with cardiovascular disease, it is worth studying water-soluble coenzyme q10 supplements to evaluate their potential role as complementary therapy for pdcm. the purpose of this study is to explore the potential role of water-soluble ubiquinol in complementary therapy for pediatric cardiomyopathy. we will recruit 25 children with primary pdcm (age 0-20 y) and examine the relationship between coenzyme q10 level and cardiac function (left ventricular fractional shortening and ejection fraction, and b-type natriuretic peptide), oxidative stress (malondialdehyde), antioxidant enzymes activity (catalase, glutathione peroxide, and superoxide dismutase), and inflammation (high sensitivity c-reactive protein and interleukin-6) in pmc after 6 months water-soluble ubiquinol supplementation (10 mg/kg bw/d, by oral drops). in addition, we will assess the quality of life of pdcm patients by questionnaire. through this study, we expect to demonstrate that water-soluble coenzyme q10 will be a complementary therapy for pdcm, and will improve cardiac function, increase antioxidant capacity, slow deterioration of cardiac function and reduce inflammation, and further reduce the rate of heart transplantation and increase quality of life in pdcm.


Eligibility criteria:
inclusion criteria: * pediatric dilated cardiomyopathy defined as left ventricular ejection fraction ≤ 40 % by cardiac echo examination. exclusion criteria: * hypertension * arrhythmia * congenital heart defects * acute myocarditis * pregnant and lactating teens * antioxidant vitamins users

Keywords: water-soluble ubiquinol supplementation pediatric cardiomyopathy antioxidant inflammation complementary therapy
does distraction with a hand held video game reduce preoperative and emergence anxiety in children?

Conditions: Pediatric Emergence Agitation and Pain

Summary: preoperative anxiety is characterized by subjective feelings of tension, apprehension, nervousness and worry. in children, preoperative anxiety is reported to result in postoperative negative psychological effects, including nightmares, eating problems and increased fear of doctors. previous studies have assessed anxiety in children during the preoperative period and the effects of premedication and parental presence. midazolzam has been shown to reduce preoperative anxiety in children but post operative recovery maybe delayed for children undergoing a short operative procedure. distraction may be particularly helpful in children ages 6-12 as these children are curious about their environment. an association between preoperative anxiety and emergence agitation has been suggested. emergence agitation in children is not well understood but is a frightening experience for child and parent. a previous study demonstrated the efficacy of hand held video games used as an interactive distraction to allay preoperative anxiety. the purpose of this study is to treat preop anxiety with premedication, or video game and to evaluate the impact of these interventions on the incidence and severity of emergence agitation.


Eligibility criteria:
inclusion criteria: * asa rating of i-ii mask induction of general anesthesia exclusion criteria: * emergency surgery children who have developmental disabilities or chronic illness children who have had repetitive surgeries children who have excessive anxiety attacks or who are currently on benzopaines

Keywords: pediatric emergence agitation and pain
a study of alisertib in combination with endocrine therapy in patients with hr-positive, her2-negative recurrent or metastatic breast cancer

Conditions: Hormone Receptor Positive HER-2 Negative Breast Cancer; Metastatic Breast Cancer; Recurrent Breast Cancer

Summary: puma-ali-1201 is a randomized, dose optimization, multicenter, phase 2 study of alisertib administered in combination with endocrine therapy in participants with pathology-confirmed hr-positive/her2-negative metastatic breast cancer (mbc) following progression on or after at least two prior lines of endocrine therapy in the recurrent or metastatic setting. this study is intended to evaluate the optimal alisertib dose administered in combination with the selected endocrine therapy. the study is also planned to evaluate the efficacy, safety, and pharmacokinetics of alisertib in combination with endocrine and to identify the biomarker-defined subgroup(s) that may benefit most from combined alisertib and endocrine therapy.


Eligibility criteria:
inclusion criteria: * aged ≥18 years at signing of informed consent. * pathology-confirmed diagnosis of adenocarcinoma of the breast with evidence of recurrent or metastatic disease not amenable to curative therapy. * progression on or after treatment with at least two prior lines of endocrine therapy in the recurrent or metastatic setting. a. if metastatic disease recurrence occurs during or within six months of discontinuing adjuvant endocrine therapy, then that endocrine therapy will count as one line of prior therapy. * participants must have received a cdk4/6i in combination with endocrine therapy in the recurrent or metastatic setting. * hr-positive and her2-negative tumor status reported per local laboratory testing. hr and her2 testing must be performed consistent with current american society of clinical oncology/college of american pathologists (asco/cap) or european society of medical oncology (esmo) guidelines: exclusion criteria: * treatment with chemotherapy in the recurrent or metastatic setting. * prior treatment with an aurora kinase a (aurka) specific-targeted or pan-aurora-targeted agent, including alisertib, in any setting. note: there are additional inclusion and exclusion criteria. the study center will determine if you meet all of the criteria.

Keywords: hormone receptor positive (hr+) human epidermal growth factor receptor 2 negative (her2-) recurrent breast cancer metastatic breast cancer
the effect of hyperextension exercises in lumbal disc hernia

Conditions: Female Patients Diagnosed With LDH at L4-S1

Summary: the aim of this study was to examine the short-term effect on pain severity, disability level, flexibility and performance level of mckenzie hyperextension exercises applied in addition to conventional physiotherapy approaches in patients diagnosed with ldh. a total of 48 consecutive female patients diagnosed with ldh at l4-s1 were randomly separated into 2 groups of 24 as the study group and control group. the control group subjects were applied with 15 sessions of conventional physiotherapy consisting of hotpack, ultrasound, and tens. the study group subjects received 15 sessions of mckenzie hyperextension exercises in addition to the conventional physiotherapy program.

aim: the aim of this study was to examine the short-term effect on pain severity, disability level, flexibility and performance level of mckenzie hyperextension exercises applied in addition to conventional physiotherapy approaches in patients diagnosed with ldh. method: a total of 48 consecutive female patients diagnosed with ldh at l4-s1 were randomly separated into 2 groups of 24 as the study group and control group. the control group subjects were applied with 15 sessions of conventional physiotherapy consisting of hotpack, ultrasound, and tens. the study group subjects received 15 sessions of mckenzie hyperextension exercises in addition to the conventional physiotherapy program. before treatment, immediately after treatment, and at 3 months after the end of treatment, the two groups were compared in respect of pain severity (visual analog scale- vas), performance level (half-squat test and the 5 times sit-stand test), flexibility level (modified sit and reach test), and disability level (oswestry disability index - odi).

Eligibility criteria:
inclusion criteria: * the patients included were diagnosed on mri with l4-s1 ldh (bulging level), * were taking no drugs other than simple painkillers, * had ldh symptoms ongoing for at least 3 months. exclusion criteria: * patients were excluded from the study if they had a history of lumbar spinal surgery, * had any disease involving the lumbar spine other than ldh (piriformis syndrome, infection, spondylosis, spondylolysis, spondylolisthesis, ankylosing spondylitis, spinal stenosis, facet syndrome, spinal malignancy, osteoporosis), * severe neurological loss, * diabetes mellitus, or were pregnant.
microendoscopic ei sensing for real-time intraoperative surgical margin assessment

Conditions: Prostate Cancer

Summary: this research will study a custom device developed to detect if any prostate cancer tissue is left behind when the prostate is removed. this device is called an electrical impedance imaging (eii) probe.

two hundred men will be recruited to participate in this trial. consent will be obtained from all participating men prior to surgery. the trial will consist of recording eii data from: 1. in vivo pelvic floor and peri-prostatic tissues remaining after the prostate has been resected 2. resected ex vivo prostate following extraction from the abdomen (in the or) 3. resected ex vivo prostate when transferred to pathology, post-rarp the study team will also track post-surgical complications due to the study's technology (e.g., infection) and additional time required to deploy the study technology used to assess feasibility of clinical integration of the eii device. post-rarp pathological assessment of margin tissues will be used to train and evaluate the study's classification schemes for identifying positive surgical margin (psms).

Eligibility criteria:
inclusion criteria: 1. clinical diagnosis of prostate cancer requiring rarp. 2. ability to understand and the willingness to sign a written informed consent document. 3. age ≥ 18 years old exclusion criteria: 1. adults with implanted electrical devices such as pacemakers 2. prisoners 3. adults with impaired decision-making capacity 4. any condition for which, in the opinion of the investigator, contraindicates study participation.

Keywords: impedance