Kornimate/medical-research-clean huggingface dataset:
flexible ureteroscopy versus eswl in the management of lower calyceal stones

Conditions: Renal Stones

Summary: to assess safety, efficacy of flexible ureteroscopy (furs) holmium:yag laser lithotripsy (ll) compared to extracorporeal shockwave lithotripsy (eswl) in management of lower calyceal stones (lc) stones.

to assess stone free rate, number of sessions and complications of flexible ureteroscopy holmium:yag laser lithotripsy compared to extracorporeal shockwave lithotripsy in the management of lower calyceal stones less than 2 cm in size.

Eligibility criteria:
inclusion criteria: * unilateral * radiopaque stone(s) * \< 2 cm * located in the lower calyx. exclusion criteria: * bleeding tendency * distal obstruction * anomalies of the urinary tract * solitary kidney

Keywords: renal stones lower calyx ureteroscopy shockwave lithotripsy holmium laser adult kidney
phase i/ii study of human anti-cytomegalovirus (cmv) monoclonal antibody msl-109 in newborns with symptomatic congenital cmv infection without central nervous system disease

Conditions: Cytomegalovirus Infections

Summary: objectives: i. evaluate the safety, tolerance, and potential efficacy of 3 doses of human anti-cytomegalovirus (cmv) monoclonal antibody sdz msl-109 (moab msl-109) in the treatment of newborns with congenital cmv infection and no central nervous system disease. ii. determine the relationship between plasma concentrations of moab msl-109 and therapeutic outcome. iii. determine whether moab msl-109 influences the antibody response and clearance of virus from the urine.

protocol outline: patients are treated with human anti-cytomegalovirus monoclonal antibody msl-109, administered intravenously every other week for a total of 3 doses. groups of 6 patients are treated at each of 3 msl-109 doses; there is no intrapatient escalation. no concurrent therapy with antibiotics for systemic infection, parenteral antifungal agents, biological response modifiers, or other antiviral agents is allowed. patients are followed every 2 weeks for 6 weeks, every 4 weeks for 12 weeks, then annually for 5 years.

Eligibility criteria:
protocol entry criteria: --disease characteristics-- symptomatic congenital cytomegalovirus (cmv) infection confirmed by urine culture no cmv acquired natally or postnatally normal eye exam and skull x-ray, computerized tomography, or magnetic resonance imaging no evidence of central nervous system cmv, e.g.: microcephaly, hydrocephaly, or hydranencephaly intracranial calcification chorioretinitis normal cerebrospinal fluid preterm: wbc no greater than 30 protein less than 120 mg/dl term: wbc no greater than 25 protein less than 80 mg/dl --prior/concurrent therapy-- at least 2 weeks since investigational drugs no prior or concurrent antiviral agents --patient characteristics-- life expectancy: no imminent demise renal: creatinine no greater than 1.5 mg/dl other: birth weight at least 1200 g no congenital toxoplasmosis, congenital rubella, or syphilis no active systemic infection, i.e.: bacterial non-cmv viral, including hiv protozoal fungal no severe concurrent clinical condition, e.g.: non-cmv congenital disease genetic abnormality moderate to severe hyaline membrane disease

Keywords: congenital cytomegalovirus infection cytomegalovirus infection herpesvirus infection immunologic disorders and infectious disorders neonatal disorders rare disease viral infection
effect of immersion bathing and showering applications on comfort level and physiological parameters of newborn

Conditions: Preterm Birth

Summary: effect of immersion bathing and showering applications on comfort level and physiological parameters of newborn

this study aims to determine the effect of immersion bathing and showering on comfort levels and physiological parameters of newborns in neonatal intensive care units. this is a randomized controlled experimental study. the sample consisted of a total of 69 newborns who were born at the 37th gestational week and above, were referred to the neonatal intensive care unit of a training and research hospital, and met the study inclusion criteria. study groups were determined through randomization by throwing a dice (immersion bathing group:35, showering group:34). environmental variables were kept the same for both groups. physiological parameters (respiration, high heart rate, oxygen saturation, body temperature) and comfort levels of newborns in both groups were compared before, just after and 15 minutes after the bath. their comfort levels were measured using the newborn comfort behavior scale (ncbs).

Eligibility criteria:
inclusion criteria: * being a newborn born at the 37th gestational week and above, * completing 24 hours following the birth * having a stable condition (no tachycardia and bradycardia) exclusion criteria: * having respiratory failure and distress (having respiratory rate between 30-60, not being monitored in the ventilator, having oxygen saturation of 90% and above, having no need for high concentrations of oxygen via methods such as hood and cpap) * having signs of infection, fever and hypothermia (having an ideal body temperature between 36-37.3 ℃) * having neurological problems (hypotonia, hypertonics, etc.), no history of convulsions, using no sedative medication, and having a normal cranial usg.

Keywords: immersion bathing showering comfort physiological parameters
scalp cooling in gynecologic cancer patients

Conditions: Gynecologic Cancer; Chemotherapy-Induced Change

Summary: in gynecologic cancers, many common chemotherapy agents can lead to chemotherapy-induced alopecia. currently scalp cooling is the most well studied preventive measure. however, its acceptability and its impact on patients' qol in asian population is unclear.

dynamic scalp cooling system prevents alopecia by inducing vasoconstriction leading to a reduction of scalp blood flow, thus reducing the delivery of cytotoxic drugs to the hair follicles and reducing follicular metabolic activities. one recent meta-analysis included 10 studies showed that the efficacy was 43% in general.

Eligibility criteria:
inclusion criteria: 1. patients must be at least 18 years old. 2. patients with primary gynecologic cancers. 3. patients who are going to receive at least four cycles of chemotherapy that are known to induce alopecia, such as carboplatin, paclitaxel, taxotere, topotecan, etoposide, vincristine and ifosfamide. 4. patients who are fit to give informed consent. exclusion criteria: 1. patients who have pre-existing alopecia of ctcae v5.0 grade 1 or above will be excluded. 2. patients who have the following conditions will be excluded: 1. migraine 2. scalp or brain metastasis 3. hypothyroidism 4. uncontrolled diabetes 5. liver and / or renal derangement (where liver enzymes and / or creatinine are 1.5x more than upper normal limit) 6. severe untreated anaemia 7. cold sensitivity 8. cold agglutinin disease, cryoglobulinemia, or cryofibrinogenemia 3. patients who had brain irradiation. 4. patients who have documented psychiatric disorders will be excluded. 5. patients who are pregnant.

Keywords: gynecologic cancer chemotherapy-induced alopecia scalp cooling
folfiri or mfolfox6 in adjuvant chemotherapy in advanced colorectal cancer

Conditions: Colorectal Cancer

Summary: the aim of this study is to observe the effect of irinotecan-based regimen in patients with advanced colorectal cancer.


Eligibility criteria:
inclusion criteria: * histologically confirmed adenocarcinoma in colorectal cancer * clinical stage ⅲ or ⅳa(with potential radical resective metastatic lesions),≥ 12 lymph nodes examined * no cancer cells were found in ascites * eastern cooperative oncology group(ecog) performance status of 0-2 * male or female, between 18 and 75 years old * adequate hematologic, hepatic and renal functions * without severe heart disease in the last 6 months before enrolled. if with hypertension or coronary artery disease, it can be controlled * not enrolled into others clinical trial during this study * all patients should sign the informed consent exclusion criteria: * can not be tolerated operation * receiving others therapy(including traditional chinese herbs)for this disease, can not obey the investigator during the study * can not be tolerated the adverse effect of drugs in these regimens * major surgery within 4 weeks prior to study treatment start, or lack of complete recovery from major surgery * metastatic disease more than one organ * pregnant or lactating women

Keywords: folfiri folfox adjuvant chemotherapy advanced colorectal cancer
visual performance, patient satisfaction and pco rate after implantation of a trifocal hydrophobic iol

Conditions: Cataract; Lens Opacities; Presbyopia

Summary: prospective, controlled, single-surgeon, single-center post-market clinical follow up study to investigate the clinical outcomes of a hydrophobic trifocal iol (physiol pod f gf)

this clinical investigation is a prospective, controlled, single-surgeon, single-center post-market clinical follow up study whereby patients undergoing routine cataract surgery will have bilateral implantation of trifocal intraocular lenses finevision pod f gf (physiol, liège, belgium). the study purpose is to obtain clinical data on visual acuity, contrast sensitivity, questionnaire outcomes and pco rate on patients implanted with finevision pod f gf. the device under investigation (finevision pod f gf) is a trifocal glistening-free hydrophobic acrylic intraocular lens (iol) manufactured by the sponsor of this study physiol sa/nv. the iol will be implanted as part of the routine cataract surgery on patients suffering from cataract development. in total 25 patients will be recruited for this clinical study and receive a bilateral implantation of finevision pod f gf intraocular lens. subjects participating in the trial will attend a total of 8 study visits (1 preoperative, 2 operative and 5 postoperative) over a period of 24 months.

Eligibility criteria:
inclusion criteria: * cataractous eyes with no comorbidity * spontaneously emitting the desire for spectacle independence after surgery and with realistic expectation. * availability, willingness and sufficient cognitive awareness to comply with examination procedures * signed informed consent exclusion criteria: * irregular astigmatism * age of patient \< 45 years * regular corneal astigmatism \>0.75 dioptres by an automatic keratometer or biometer or \>1.0 dioptres if the steep axis of cylinder is between 90° and 120° in one or both eyes * difficulty for cooperation (distance from their home, general health condition) * acute or chronic disease or illness that would increase risk or confound study results (e.g. diabetes mellitus (with retinopathy), immunocompromised, glaucoma etc...) * any ocular comorbidity * history of ocular trauma or prior ocular surgery including refractive procedures * capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome, chronic uveitis, marfan's syndrome) * pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils or pupils that do not dilate under mesopic/scotopic conditions) * amd suspicious eyes (determined by oct) * complicated surgery

Keywords: intraocular lens trifocal hydrophobic hydrophilic
tap block catheters vs liposomal bupivacaine for pain control after colorectal surgery

Conditions: Colorectal Surgery; TAP Blocks

Summary: this is a prospective randomized study designed to compare the pain control from a single shot of liposomal bupivacaine (exparel) against transversus abominus plane (tap) catheters with ropivicaine bolus in patients undergoing elective colorectal surgery.

at uc davis, it is standard practice to place tap blocks with catheters for adult colorectal surgery patients for perioperative pain control. this practice, however, is resource intensive, adds the risk of catheter-related complications, and adds increased burden to patients by requiring them to be tethered to 2 catheters. an alternative tap can be performed using a single shot of liposomal bupivacaine (exparel), an extended release local anesthetic that is fda-approved for surgical plane infiltration including tap blocks. with this prospective study, we seek to improve patient care at uc davis and educate other institutions through the use of concrete data comparing these 2 treatment options.

Eligibility criteria:
inclusion criteria: * patients scheduled for elective colorectal surgery with dr. linda farkas exclusion criteria: * patients under 18 years of age * patient over 90 years of age * pregnancy * prisoners * patients unable to provide consent * patients on systemic anticoagulation therapy * patients with an allergy to local anesthetics
the pre-diabetes interventions and continued tracking to ease-out diabetes (pre-dicted) program

Conditions: Pre-diabetes

Summary: the pre-dicted (pre-diabetes intervention and continued tracking to ease-out diabetes) program is a community-based diabetes prevention program. this study aims to test the effectiveness of structured, group-based lifestyle interventions with stepwise addition of metformin, if required, among subjects with pre-diabetes in multi-ethnic singapore.

the pre-dicted program is designed as a randomized, controlled, pragmatic trial. the program targets to recruit up to 846 overweight/obese (bmi ≥23.0) adults (age 18-64) with isolated impaired fasting glucose (ifg), isolated impaired glucose tolerance (igt), or ifg + igt in singapore. the follow-up period will be 3 years. eligible subjects will be identified through community, primary care clinics and hospital-based diabetes screening program. following informed consent, eligible participants will be randomised into the control or the treatment arm. participants in the control arm will receive the current standard of care for pre-diabetes which includes counseling on lifestyle modifications and follow up by primary care physicians. participants in the treatment arm will undergo a 3-month, locally tailored, group-based lifestyle intervention program (consisting of nutrition workshops, exercise sessions and goal-setting workshop) plus subsequent stepwise addition of metformin for selected participants at the highest risk of progression to diabetes at ≥ 6 months of follow-up. financial incentives will be awarded to participants who achieve weight lost of ≥5% of baseline weight during follow-up period. the primary outcome of diabetes incidence will be assessed bi-annually and compared across the study arms. secondary outcomes will include weight, waist circumference, fasting plasma glucose (fpg), 2-h glucose, hba1c, physical activity, diet and metformin adherence.

Eligibility criteria:
inclusion criteria: 1. singapore citizens or permanent residents 2. age between 18 and 64 3. body mass index (bmi) ≥ 23.0 kg/m2 4. pre-diabetes diagnosed based on: 1. fasting plasma glucose 6.1 - 6.9 mmol/l (impaired fasting glucose; ifg) and/or 2. 2-hr plasma glucose in 75g oral glucose tolerance test (ogtt) 7.8 - 11.0 mmol/l (impaired glucose tolerance; igt) (laboratory tests to be done within 6 months of enrolment) exclusion criteria: 1. individuals with diabetes mellitus 2. health conditions impeding participation in lifestyle change programme (e.g. active cancer, recent myocardial event within 6 months, heart failure, chronic kidney disease) 3. current pregnancy or breast feeding 4. treatment with medications known to alter glucose tolerance 5. known allergic reaction to metformin
a study of atezolizumab (mpdl3280a) compared with a platinum agent (cisplatin or carboplatin) + (pemetrexed or gemcitabine) in participants with stage iv non-squamous or squamous non-small cell lung cancer (nsclc) [impower110]

Conditions: Non-Squamous Non-Small Cell Lung Cancer, Squamous Non-Small Cell Lung Cancer

Summary: this randomized, open-label study will evaluate the efficacy and safety of atezolizumab compared with chemotherapy consisting of a platinum agent (cisplatin or carboplatin per investigator discretion) combined with either pemetrexed (non-squamous disease) or gemcitabine (squamous disease) in programmed death-ligand 1 (pd-l1)-selected, chemotherapy-naive participants with stage iv non-squamous or squamous nsclc.


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed, stage iv non-squamous or squamous nsclc * no prior treatment for stage iv non-squamous or squamous nsclc. participant known to have a sensitizing mutation in the epidermal growth factor receptor (egfr) gene or an anaplastic lymphoma kinase (alk) fusion oncogene are excluded from the study * tumor pd-l1 expression as determined by immunohistochemistry (ihc) assay of archival tumor tissue or tissue obtained at screening * eastern cooperative oncology group (ecog) performance status 0 to 1 * measurable disease as defined by response evaluation criteria in solid tumors (recist v1.1) * adequate hematologic and end-organ function exclusion criteria: * known sensitizing mutation in the egfr gene or alk fusion oncogene * active or untreated central nervous system (cns) metastases as determined by computed tomography (ct) or magnetic resonance imaging (mri) evaluation * malignancies other than nsclc within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome * pregnant or lactating women * history of autoimmune disease * history of idiopathic pulmonary fibrosis, organizing pneumonia, drug induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest ct scan. history of radiation pneumonitis in the radiation field (fibrosis) is permitted * positive test for human immunodeficiency virus (hiv) * active hepatitis b or hepatitis c * prior treatment with cluster of differentiation (cd) 137 agonists or immune checkpoint blockade therapies, anti pd1, and anti-pd-l1 therapeutic antibody * severe infection within 4 weeks prior to randomization * significant history of cardiovascular disease
the s100β levels in patients with mild brain injury.

Conditions: Brain Concussion

Summary: mild traumatic brain injury (tbi) accounts for the majority of tbi. at present, whether tbi has traumatic intracranial lession is mainly diagnosed by computed tomography (ct), while only 5% of mild tbi has positive ct results. the risk stratification method for patients with mild tbi is needed to reduce unnecessary ct use and reduce medical costs. s100β is a protein in glial cells and can be used as a biomarker of brain injury. s100β is showed to have the clinical and economic value in ruling out traumatic intracranial lesions in mild tbi patients in europe and the united states. however, it was showed to have difference between races, and there lacks systematic research data from chinese population. in addition, if it is used for emergency departments, it is necessary to evaluate new rapid detection methods. this study is based on a novel fast s100β test. the reference intervals of s100β in chinese adults will be established. further, evaluation of s100β in diagnosis of traumatic intracranial lesions in acute mild tbi will be conducted from the perspective of clinical and economic value in china, which will provide data for screening of low-risk tbi patients and avoiding unnecessary ct use in clinical practice.


Eligibility criteria:
inclusion criteria: 1. study on healthy people: apparently healthy people \>18 years old who came to our hospital for physical examination. 2. study of emergency trauma patients: 1) emergency trauma patients at least 18 years old with suspected brain injury; 2) glasgow coma score 13-15 (patients with mild traumatic brain injury); 3) closed head trauma; 4) clinical judgment of patients requiring craniocerebral ct examination. exclusion criteria: 1. healthy population study: stroke history, trauma, surgery, mental illness, senile dementia, cognitive impairment, and tumor patients within 3 months. 2. study of emergency trauma patients: 1) neurological or psychiatric history, 2) intellectual disabilities, 3) alcohol or drug addiction (trauma after drinking was eligible for inclusion, but alcohol consumption was recorded), 4) brain tumor patients, 5) time of trauma was not available, and 6) patients whose clinical conditions were deemed unsuitable for participation in the trial.
effects of preoperative anxiety and preemptive analgesia on postoperative delirium in septo/rhinoplasty surgery

Conditions: Preoperative Anxiety; Postoperative Delirium

Summary: effects of preoperative anxiety and preemptive analgesia on postoperative delirium in septo/rhinoplasty surgery

it is known that preoperative anxiety causes postoperative agitation. in adult patients, preoperative anxiety is assessed with the beck anxiety inventory (bai) and bai≥16 is considered 'anxious'. postoperative agitation is assessed with the riker sedation-agitation scale (rsas) and rsas ≥5 is considered agitated, pain is assessed with the numerical pain scale (nrs) \>4 is considered postoperative pain. measurements were recorded at 0, 5, 10 and 15 minutes postoperatively. there are factors such as inhalation agents, preoperative anxiety and postoperative pain in its etiology.

Eligibility criteria:
inclusion criteria: * - 18-65 years old, * asa i-ii risk group * those who will be operated under general anesthesia under elective conditions. * will undergo surgery for septo/rhinoplasty * patients whose informed consent form was read to their parents was obtained exclusion criteria: * -those do not want to participate in the study, * asa iii -iv-v patients * having a history of drug allergy and drug interaction, * having a history of systemic disease such as heart, kidney, liver failure, * having a history of bleeding diathesis, * difficult intubation expected, * obese, * emergency patients, * mental-motor retarded, * having psychiatric and neurological diseases, * those with chronic drug use