Kornimate/medical-research-clean huggingface dataset:
efficacy and safety analysis of icis plus angiogenesis inhibitors for treatment of advanced nsclc in elderly patients

Conditions: NSCLC

Summary: immune checkpoint inhibitors(icis) combined with angiogenesis inhibitors may is synergistic in elderly patients with advanced non-small cell lung cancer(nsclc), however its true efficacy is still unclear. the investigators retrospectively compared clinical efficacy and safety of driver-negative elderly patients with advanced nsclc treated with icis with(or without)angiogenesis inhibitors in the cancer center of the affiliated suzhou hospital of nanjing medical university.

the investigators reviewed the medical records of all lung cancer patients in the cancer diagnosis and treatment center of suzhou hospital affiliated to nanjing medical university from january 1, 2019 to december 31, 2021, and a total of 79 patients were enrolled. the subjects were divided into two groups: the group treated with immune checkpoint inhibitors plus antiangiogenic drugs(ia group) and the group treated with immune checkpoint inhibitors without antiangiogenic drugs(nia group). the data of pfs, os, orr, covariates, and immune-related adverse events (iraes) were collected through electronic medical records and follow-up. the primary endpoint of the study was pfs, and the secondary endpoints were os, orr and iraes.all enrolled patients were followed up until august 1, 2022.

Eligibility criteria:
inclusion criteria: 1. age ≥65 years old. 2. stage iv according to the ajcc cancer grading manual (8th edition). 3. histologically confirmed nsclc. 4. no driver mutations. 5. received at least 2 courses of immunotherapy. 6. expected survival time \> 3 months. 7. no concurrent malignancy. 8. not participating in a clinical trial. 9. the functions of important organs were basically normal. 10. sign informed consent.

Keywords: elderly patient
a randomised controlled trial comparing bone anchored hearing aid with bonebridge

Conditions: Hearing Loss, Conductive; Bone Conduction Deafness

Summary: the bonebridge is a new bone conducting implantable hearing aid. the investigators plan to randomize patients to receive either the bonebridge or a conventional bone conducting hearing device. the investigators will then compare the surgical and audiological outcomes of the two groups.

the new bonebridge fully implanted, except for an external sound processor. it does not have any percutaneous parts like the bone anchored hearing aid. the investigators believe that this may improve wound healing and reduce problems with wound infection and skin overgrowth seen in bone anchored hearing aids. there may also be audiological improvements by the use of the bonebridge as the physical separation of the vibrating part from the sound processor should reduce feedback. the company also claims other audiological improvements in the bonebridge. the investigators wish to demonstrate whether this is actually the case by performing a study directly comparing the outcomes of the two groups.

Eligibility criteria:
inclusion criteria: * conductive hearing loss within criteria for bonebridge * adults exclusion criteria: * children * pregnancy

Keywords: hearing loss, conductive bone conduction bone conduction thresholds better than 45 dbhl
assessment of the efficacy on the 5th day of antibiotic therapy for febrile urinary tract infections among children from 3 months to 18 years old

Conditions: Urinary Tract Infections; Pediatric Disorder

Summary: the main objective is to describe the rate of asymptomatic patients after 5 days of effective antibiotic therapy in an uncomplicated febrile urinary tract infection in children between 3 months and 18 years of age.

this is a non-randomised prospective monocentric pilot study whose main objective is to describe the proportion of asymptomatic patients after 5 days of effective antibiotic therapy in an uncomplicated febrile urinary tract infection, in children between 3 months and 18 years of age. after being informed about the study, all patient meeting inclusion criteria will respond to a survey at d2, d5, d10 and d28 to evaluate the persistence of symptoms to determine the effectiveness of a 5-day course of antibiotic treatment. all patients will be treated in accordance to the french guidelines.

Eligibility criteria:
inclusion criteria: * child between 3 months and 18 years old * diagnosis of uncomplicated febrile urinary tract infection certain and defined by : * naked fever (without an identifiable source of infection) for at least 24 hours for boys and 48 hours for girls. * a urine test strip with at least 2 crosses of leukocyturia ≥ or 1 cross of leukocyturia ≥ with positive nitrituria * a cytobacteriological urine test with leukocyturia greater than 10/mm3 in the case of catheterisation or clean catch or greater than 100/mm3 if the collection is performed by bag (urinocol®). * positive bacteriological urine culture * response to antibiotic therapy * absence of other diagnoses that could explain the clinical picture exclusion criteria: * children under 3 months old * immunodepression * underlying uropathy or known neurological bladder disease
topical nitro or placebo pre-cath

Conditions: Coronary Artery Disease

Summary: phase 2, single-center, randomized, blinded clinical study to assess the safety and efficacy of topical nitroglycerin on ease of tra during scheduled pci. we will compare topical nitroglycerin to placebo applied prior to planned, non-urgent pci to determine if nitroglycerin is associated with decreased number of arterial puncture attempts made, decreased time to radial access, and lower crossover rate to tfa. subjects will be randomized to receive either topical nitroglycerin ointment or placebo prior to scheduled pci. there will be 256 subjects enrolled in this study with 1:1 randomization.

percutaneous coronary intervention (pci) procedures performed by entering the radial artery, or the transradial approach (tra), is associated with reduced vascular access site complications, bleeding, and length of hospital stay, as well as greater patient satisfaction when compared to the transfemoral approach. one of the major challenges to a successful tra remains the small size of the radial artery. the potential need for larger catheters during pci has been one factor limiting broader adoption of tra and a common reason for crossover from tra to femoral access intraprocedurally. additionally, multiple unsuccessful attempts to access the radial artery leads to unnecessary bleeding and may lead to severe arterial vasospasms. nitroglycerin, a vasodilator, is available in a topical form and may be used prior to pci to dilate the radial artery and potentially increase the rate of successful tra.

Eligibility criteria:
inclusion criteria: 1. male or non-pregnant female \> 18 years of age at the time of consent 2. scheduled to undergo pci using tra in the cardiac catheterization laboratory 3. able to provide informed consent with capacity, given in english. exclusion criteria patients with any of the following characteristics or conditions will not be included in the study: 1. known nitrate allergy 2. allergy to cerave moisturizing lotion 3. baseline hypotension with systolic blood pressure \<90mmhg 4. absence of radial artery blood flow in one or both arms 5. presence or history of liver, rheumatologic, or chronic kidney disease 6. current treatment with any vasodilator therapy (eg. sildenafil) 7. radial artery catheterization \<30 days prior to enrollment 8. active site infection 9. av-fistula or prior radial artery harvest for bypass surgery
medicinal dependence and chronic pain: addictive evaluation in cetd

Conditions: Opiate Dependence; Chronic Pain

Summary: prescription opioid misuse in chronic pain is a growing public health concern. few studies got interested in prevalence of misuse and of opiate use disorder in a population of patients with a non cancer chronic pain. the investigators analyzed during 3 months opiate misuse and opiate ude disorder in a population of patients consulting a center specialized in pain management.


Eligibility criteria:
inclusion criteria: * patient with a non cancer chronic pain * consulting a cetd center exclusion criteria: * non understanding of french
culinary art therapy group for adults with eating disorders.

Conditions: Eating Disorders; Behavior, Eating; Relationship, Family; Cognitive Change

Summary: the study will assess the influence of culinary art therapy group (a new therapeutic tool) for adults with eating disorders. it will assess changes in thinking patterns and behavioural patterns associated with food and eating.


Eligibility criteria:
inclusion criteria: * a diagnosis of eating disorder * body mass index (bmi) \> 15 exclusion criteria: * no active participation in three group sessions * refusal to take an active part in the sessions
fostering sustainability through diabetes self-management support

Conditions: Diabetes Mellitus

Summary: to understand the effectiveness of three approaches to address diabetes self-management support compared to enhanced usual care in church-based settings.

to understand the effectiveness of three approaches to address diabetes self-management support compared to enhanced usual care in church-based settings.

Eligibility criteria:
inclusion criteria: * have type 2 diabetes for at least 6 months * be black/african american * be a resident of metro-detroit, toledo, or flint * be at least 21 years old * be under the care of a physician for diabetes * have transportation to attend the program exclusion criteria: * have type 2 diabetes for less than 6 months * under 21 years of age * not under care of physician * lack of transportation to attend the program

Keywords: african-american
optokinetic stimulation for hemineglect

Conditions: Perceptual Disorders; Unilateral Spatial Neglect

Summary: hemineglect is a sequel to stroke, which appears more frequently when the injury occurs in the right cerebral hemisphere. hemineglect refers to those patients who do not pay attention to their left side, presenting movement disorders that do not allow them to participate spontaneously in their activities of daily life. there are different methodologies for the treatment of hemineglect. among them, we find optokinetic stimulation (oks), which consists of creating an illusory movement to the left to center the patient's frame of reference and thus, make them pay more attention to their left side. in recent years, the effect that this therapy has on motor movement disorders has begun to be explored, although the parameters for its correct application still seem to be unclear. for this reason, our aim is to describe the effect that the oks has on balance, posture, spatial representation and conscience, and movement disorders in hemineglect. patients with hemineglect will undergo oks to see its influence on the recovery of this sequel of stroke.


Eligibility criteria:
inclusion criteria: * 18 year old or older * diagnosis of right stroke * diagnosis of left heminegligence exclusion criteria: * no cooperation and comunication problems * uncontrolled epileptic seizures or migraines

Keywords: perceptual disorders unilateral spatial neglect optokinetic stimulation photic stimulation
effects of iloprost on pulmonary oxygenation in obese patients during one-lung ventilation

Conditions: Lung Cancer (Including Metastatic Cancer); Pulmonary Infection

Summary: one lung ventilation (olv) is essential during thoracic surgery. during olv, intrapulmonary shunt can be increased resulting hypoxemia. although olv technique had been advanced so far, hypoxemia during olv reaches about 10% in spite of inspired oxygen fraction 100%. iloprost is a prostaglandin analogue used for pulmonary hypertension, which can decrease pulmonary artery resistance by selectively dilating pulmonary artery. in this prospective, randomized, double blind study, the investigator is planning to investigate the effects of iloprost on respiratory physiology (intrapulmonary shunt, deadspace, oxygenation, etc) in obese patients.


Eligibility criteria:
inclusion criteria: 1. scheduled for vats lobectomy 2. 40 \< age \< 80 3. american society of anaesthesiologists(asa) physical status classification i\~iii 4. bmi \> 30 kg /m2 exclusion criteria: 1. american society of anaesthesiologists(asa) physical status classification iv or more 2. nyha class iii\~iv 3. severe obstructive lung disease and/or restrictive lung disease patients 4. patients with end-organ diseases (i.e. heart failure, respiratory failure, hepatic failure, renal failure) 5. arrhythmia 6. pregnant women 7. pulmonary edema or pulmonary arterial hypertension 8. cerebrovascular disease 9. unstable angina or myocardial infarction within 6 months 10. patients with allergic reaction at iloprost
new technologies for intensive prevention programs - net-ipp

Conditions: Coronary Artery Disease

Summary: in a randomized trial patients hospitalized for myocardial infarction are prospectively enrolled and assigned to either a web-based intensive prevention program or usual care (1 : 1 randomization). the web-based program includes telemetric transmission of data on cardiocascular risk factors (physical activity, blood pressure, body weight) by patients to the study center, e-learning modules by the study center and repetitive electronic contacts by e-mails and apps between a prevention assistant and the patient. in addition, genetic risk on cardiovascular events will be assessed in all patients of the intervention group by a polygenetic risk score (prs). patients of the intervention group are randomly assigned to disclosure of genetic risk vs. no disclosure. the study hypothesis is that disclosure of genetic risk improves cardiovascular risk factor control by increased patient motivation.


Eligibility criteria:
inclusion criteria: 1. hospitalization due to acute myocardial infarction (st-elevation or non-st-elevation myocardial infarction) defined according to valid international guidelines 2. access to internet and consent to participate in a web-based prevention program 3. consent for genetic risk assessment for cardiovascular events and risk disclosure according to randomization exclusion criteria: 1. patient refusal or inability to give informed consent 2. hemodynamically significant valvular heart disease 3. exercise limitations due to clinical conditions not related to cad (such as severe orthopedic disorders,..) 4. any major non-cardiac condition that would adversely affect survival during the duration of the study (such as cancer with prognosis \< 2 years,..) 5. inability to cooperate with the protocol, including longterm follow-up 6. chronic drug and alcohol abuse
sintilimab plus chemotherapy followed by dcrt in locally advanced escc

Conditions: Esophageal Squamous Cell Carcinoma

Summary: the purpose of this study is to observe and evaluate the efficacy and safety of a sintilimab plus chemotherapy followed by definitive concurrent chemoradiotherapy in locally advanced esophageal squamous cell carcinoma.


Eligibility criteria:
inclusion criteria: 1. written informed consent 2. aged 18-75 years 3. histologically confirmed esophageal squamous cell carcinoma 4. clinical stages t3-4n0m0 or txn1m0 or txnxm1a or txnxm1b (only for cervical lymph nodes or celiac lymph nodes metastasis) based on the 6th uicc-tnm classification 7. eastern cooperative oncology group(ecog) performance status: 0-1 8. life expectancy ≥3 months 9. adequate organ functions absolute neutrophil counts (anc) ≥1.5×109⁄l; hemoglobin (hb) ≥9g⁄dl; platelet (plt) ≥100×109⁄l; total bilirubin ≤1.5 upper limit of normal (uln); aspartate transaminase (ast) ≤2.5 uln; alanine aminotransferase (alt) ≤2.5 uln; creatinine ≤1.5 uln exclusion criteria: 1. esophageal perforation or hematemesis 2. any active autoimmune disease or a history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism and hypothyroidism (effective hormone replacement therapy excepted)) and immunosuppressive agents or systemic hormonal therapy indicated within 28 days (for adverse events of chemoradiotherapy excepted). 3. previously received or receiving other pd-1 antibody therapy or other immunotherapy against pd-1/pd-l1. 4. allergic to macromolecular protein preparations, or to any of the ingredients in sintilimab for injection. 5. uncontrolled heart diseases or clinical symptoms, such as: (1) new york heart association(nyha) class ii or higher heart failure; (2) unstable angina; (3) myocardial infarction within 1 year; (4)clinically significant arrhythmia requiring clinical intervention. 6. congenital or acquired immunodeficiency (such as hiv infection); active hepatitis b (hbv-dna≥104 copy number/ml) or hepatitis c (positive hepatitis c antibody, and hcv-rna is higher than the detection limit of the analytical method); active tuberculosis. 7. active infection or unexplained fever \>38.5 °c within 2 weeks before randomization (fever due to tumor excepted, according to investigator). 8. patients with fertility reluctant to take contraceptive measures during the trial, or female patients pregnant or breastfeeding. 9. according to the investigator, other factors that may cause termination of the study. ie, other serious diseases (including mental illness) require combined treatment, family or social factors, which may affect the safety or the collection of trial data.
a comparison between d1 and d2 lymphadenectomy in gastric cancer : a prospective randomized controlled trial

Conditions: Gastric Cancer

Summary: gastric cancer remains the second most common cancer worldwide.although the prognosis is poor for majority of patients , long term survival is achievable in patients in whom surgical resection is possible. however the results of surgery are generally disapointing in most large series.the exception to this appears to be japan and far east where a standardized approach to surgery is undertaken with low morbidity and mortality.the extent of surgery and particularly the development of systematic lymphadenectomy(d2)has been credited in japan for the improved outcome in patients with gastric cancer. hence for comparing the difference between d1 and d2 lymphadenectomy for gastric cancer in terms of overall survival,disease free survival and loco regional recurrence and also post operative morbidity and mortality following both these procedures,this study has been undertaken. in d1 lymphadenectomy, only those lymph nodes which are adjacent to the part of stomach being resected will be removed.in d2 lymphadenectomy other lymph nodes draining the stomach will also be removed according to internationally accepted guidelines and also include resection of greater omentum along with anterior layer of transverse mesocolon and lesser omentum upto its attachment to hepatoduodenal ligament. currently both these procedures are widely practised worldwide and there is no definite evidence showing the superiority of one procedure over the other.neither is any of these procedures experimental. we are doing this trial to see whether one of these procedures is superior to the other.


Eligibility criteria:
inclusion criteria:patients with biopsy/frozen section proven adenocarcinoma of stomach. * preoperative clinical examination and imaging indicating operable disease. * intraoperative exploration indicating operability i.e. no peritoneal deposits,no evidence of para aortic lymphadenopathy,no direct involvement of contiguous organs * surgical plan for distal/proximal/total gastrectomy exclusion criteria:patients with low performance score * staging investigations or intraoperative exploration indicating inoperable disease * patients medically unfit for major surgery * patients who have been given preoperative chemotherapy/chemoradiation. * patients with gastroesophageal junction tumours * patients unreliable for follow up * patients above the age of 70 years * past history of malignancy

Keywords: comparison between d1 and d2 lymphadenectomy for gastric cancer
washington university participant engagement and cancer genomic sequencing center (wu-pe-cgs)

Conditions: Cholangiocarcinoma; Multiple Myeloma; Colon Cancer; Rectal Cancer

Summary: the overall goal of the wu-pe-cgs is to build a rigorous, scientific evidence base for approaches that direct engagement of cancer patients and post-treatment cancer survivors as participants in cancer research, and to investigate the impact of directly engaging participants in decisions regarding returning of genomic results on participants' health and satisfaction. participants in this study will be presented with the choice of types of genomic results to receive, and the engagement optimization unit (eou) will investigate the impact of this intervention on participant knowledge, expectations of benefit, personal utility, and decisional conflict.


Eligibility criteria:
eligibility criteria: * patients with cholangiocarcinoma, multiple myeloma, or early onset colon or rectal cancer. * if diagnosed with multiple myeloma, must be african-american. * if diagnosed with colon or rectal cancer, must be african-american and must be no older than 65 years old at the time of diagnosis. * at least 18 years old * able to understand and willing to sign an irb-approved written informed consent document

Keywords: participant engagement genetic testing cholangiocarcinoma multiple myeloma colorectal cancer underrepresented populations
biomarkers of mild and moderate traumatic brain injury

Conditions: Brain Injuries, Traumatic

Summary: the purpose of this study is to assess if putative brain injury biomarkers have utility as blood-based traumatic brain injury (tbi) diagnostic and monitoring tools. this will be accomplished by examining the relationships between potential serum-based tbi biomarkers and clinical measures of injury severity, occurrence of complications, and outcome, in subjects with mild or moderate tbi. the assay will be evaluated in a sample population of subjects over the age of 18 who have been referred to the health care provider for closed head injury evaluation.


Eligibility criteria:
inclusion criteria: 1. at least 18 years of age and no more than 80 years of age. 2. closed injury to the head within 4 hours from symptom onset. 3. glasgow coma scale (gcs) score of 9-15. 4. head computerized tomography (ct) performed as part of routine care. 5. subject is willing to undergo the informed consent process prior to enrollment. 6. based upon the principal investigator's opinion, subject is an appropriate candidate for the study. exclusion criteria: 1. participating in another clinical study that may affect the results of either study. 2. time of injury cannot be determined. 3. head ct not done as part of clinical emergency care. 4. primary diagnosis of ischemic or hemorrhagic infarct. 5. not available for 35 day follow-up visit. 6. venipuncture not feasible. 7. blood donation within 1 week of screening. 8. the subject is otherwise determined by the investigator to be medically unsuitable for participation in this study.