Kornimate/medical-research-clean huggingface dataset:
immunonutrition in eras protocols in gynecologic oncology

Conditions: Nutritional Deficiency; Gynecologic Cancer; ERAS

Summary: a patient with oncological pathology of any type because of impaired digestion and nutrient absorption, decreased intake, and increased nutrition requirements has an increased risk of malnutrition and moderate to severe weight loss.in the present study the investigators will evaluate the impact of perioperative immunonutrition supplementation on the postoperative outcomes.

malnutrition has a major effect not only on the postoperative course of cancer surgery but can also complicate or even limit administration or compromise the effectiveness of other treatments such as chemotherapy or radiotherapy in the perioperative period. immunonutrition is a type of artificial nutrition based on the use of some types of macro- or micronutrients.the purpose of this review was to evaluate the use, indications, and effects of these formulas in oncologic surgical patients in real time and to identify the types of patients who can benefit from enteral immunonutrition.

Eligibility criteria:
inclusion criteria: * women with any gynaecologic malignancy enrolled in surgical list of our institute * must be able to consume oral supplements. exclusion criteria: * women that are not able to follow eras protocol due to medical reasons * patients with severe disease that cannot compromise with protocol
prognostic value of lymph node dissection in patients with transitional cell carcinoma of the upper urinary tract

Conditions: Lymph Node Dissection

Summary: recent studies showed the therapeutic benefit of lymphadenectomy in advanced stage urothelial carcinoma of the upper urinary tract, but there is still a lack of prospective studies. thus, the current guideline recommends lymph node dissection for invasive upper tract urothelial carcinoma (utuc) on the basis of insufficient evidence. also, the preoperative judgment of muscle invasive pathological stage t 2+,or n+ is difficult from preoperative imaging. in the investigators' clinical practice, the surgeons performed dissection of regional lymph nodes only in patients with enlargement of lymph nodes found in preoperative imaging or during surgery. the aim of this multi-institutional study was to examine the role of lymphadenectomy in urothelial carcinoma of the upper urinary tract.


Eligibility criteria:
inclusion criteria: * clinically diagnosed with upper tract urothelial carcinoma * have no distant metastasis * have an eastern cooperative oncology group (ecog) score 0 to 2 * expected to receive radical nephroureterectomy exclusion criteria: * a prior history of bladder cancer * administration of neoadjuvant chemotherapy * deny to receive long term follow-up * patients with contralateral utucs * patients with synchronous muscle invasive bladder cancer

Keywords: urothelial cancer nephroureterectomy upper urinary tract
chemotherapeutic trial with gemcitabine, cisplatin, 5-fu and folinic acid in esophageal cancer

Conditions: Esophageal Cancer

Summary: this multicenter open labeled phase 2 trial examines the efficacy of a combination of gemcitabine 1000 mg/m2 (30 min), cisplatin 30 mg/m2 (90 min), folinic acid 200 mg/m2 (30 min) and 5-fu 750 mg/m2 (24h ci) all given day 1,8 q d22 in patients with inoperable esophageal cancer. the combination was considered to be suitable for further evaluation with a freedom of progression rate (pr+cr+sd) of more than 60% and not be be of further interest with a rate of less than 40%. given an alpha error of 5% and an beta error of 10% at least 66 evaluable patients were needed based on a 2-stage simon design with a first evaluation after 25 evaluable patients.


Eligibility criteria:
inclusion criteria: * age\>=18 * histologically proven inoperable esophageal cancer * karnofsky performance status \>=60% * estimated life expectancy of \> 12 weeks * measurable disease * no other oncologic therapy * measurable disease * adequate bone marrow function * geographic proximity and compliance * informed consent * negative pregnancy test and adequate contraception exclusion criteria: * insufficient hepatic or renal function * elevated serum calcium * pregnancy/breast feeding * active infection * other malignancies * systemic tumour complications requiring emergency interventions

Keywords: esophageal cancer gemcitabine cisplatin 5-fu folinic acid inoperable esophageal cancer
a study of lurasidone hcl in subjects with schizophrenia

Conditions: Schizophrenia

Summary: the study evaluates the effectiveness and safety of lurasidone in subjects with schizophrenia over a period of 6 weeks.


Eligibility criteria:
inclusion criteria: 1. males or female aged at 20-75 years old 2. subjects who are diagnosed with schizophrenia based on diagnostic and statistical manual of mental disorders (dsm-v) criteria 3. cgi-s≦4 (at both screening and baseline) 4. subject is judged by the investigator to have been clinically stable for at least 4 weeks prior to baseline and in need for a switch from their current antipsychotic treatment due to insufficient clinical response or poor tolerability (side effects, metabolic complications, etc.). 5. if the subject recruits from opd, the subject should be intolerant to the ae or is insufficient in current antipsychotics treatment by investigator's judgment. 6. childbearing potential women who consented to the consistent use of the acceptable contraception (oral contraceptive, contraceptive injection, intrauterine device, double barrier method and contraceptive patch) 7. subject is able and agrees to remain off (or stable dosage) prior antipsychotic medication during the study period as defined by this protocol. 8. in the investigator's opinion, the ability to understand the nature of the study and any hazards of participation, and to communicate satisfactorily with the investigator and to participate in, and to comply with, the requirements of the entire protocol. 9. subject is willing and able to comply with the protocol. exclusion criteria: 1. subject has clinically substantial risk of suicide or violent behavior as judged by the investigator. 2. subject with the past history of neuroleptic malignant syndrome, water intoxication, paralytic ileus or dementia related psychosis 3. subjects is active pregnancy (must have a negative pregnancy test at screening) or nursing (must not be lactating). 4. subject has received treatment with mao inhibitors within 14 days prior to the screening (visit 1). 5. subject is currently participating, or has participated in, a study with an investigational or marketed compound or device within 1 month prior to signing the informed consent. 6. subject is unstable or critical untreated medical illness by the judgment of investigators. 7. subject who is otherwise considered ineligible for the study by investigator. for example, subjects experienced serious medical condition including known clinically relevant laboratory abnormalities, and hypersensitivity to lurasidone. 8. subjects who were considered resistance to treatment for psychotic symptoms by the investigator. 9. total daily dose of pre-switch antipsychotic was exceeded the equivalent of haloperidol 12 mg/day. 10. subjects have received long depot neuroleptics within 4 weeks prior to enrollment. or, subject was treated with clozapine for refractory psychosis within 1 month of enrollment. 11. subject requires treatment with any potent cyp3a4 inhibitors or inducers during the study. subject requires treatment with a drug that consistently prolongs the qtc interval.
promoting activity and cognitive enrichment in schizophrenia (paces)

Conditions: Schizophrenia

Summary: this project will conduct a confirmatory efficacy trial of two novel psychosocial interventions, cognitive enhancement therapy and enriched supportive therapy, for the treatment of persistent negative symptoms in schizophrenia.

this project will conduct a confirmatory efficacy trial to examine the efficacy of cognitive enhancement therapy (cet) and enriched supportive therapy (est) for the treatment of schizophrenia patients with significant and persistent negative symptoms. a total of 90 stabilized schizophrenia outpatients with moderate-to-severe persistent negative symptoms will be randomized to 18 months of cet or est. comprehensive data on persistent negative symptoms, social and non-social cognition, and functional outcome will be collected prior to treatment and at frequent 6-month intervals to (1) confirm the efficacy of cet and est for improving persistent negative symptoms; (2) confirm the impact of cognitive target engagement on reduced negative symptoms; and (3) examine the short-term durability of cet and est effects on negative symptoms and functioning.

Eligibility criteria:
inclusion criteria: inclusion criteria will be evaluated longitudinally in a 4-week evaluation period. patients will be included if they are outpatients and: 1. are between 18-60 years of age; 2. have a diagnosis of schizophrenia or schizoaffective disorder confirmed by the scid; 3. have a clinical history of persistent negative symptoms lasting at least 3 months as identified from the medical record; 4. have observed persistent negative symptoms at the beginning and end of the 4-week evaluation period; 5. have been stabilized on antipsychotic medication at the beginning and end of the 4-week evaluation period; 6. have stabilized depressive symptoms at the beginning and end of the 4-week evaluation period; 7. have mild or absent extrapyramidal symptoms at the beginning and end of the 4-week evaluation period; 8. have had changes to their primary antipsychotic medication within the previous 3 months; 9. have current iq \> 80; and 10. are able to read (sixth grade level or higher) and speak fluent english. - exclusion criteria: exclusion criteria are intended to avoid likely treatment confounders and contraindications and include: 1. the presence of organic brain syndrome; 2. comorbid medical disorders producing cognitive impairment (e.g., mild brain injury, previous concussions with loss of consciousness); 3. persistent suicidal or homicidal behavior; 4. significant clinician-estimated medication non-adherence; and 5. scid-verified substance use disorder.

Keywords: negative symptoms cognition social cognition
clinical evaluation of the neumodx sars-cov-2 assay (covid-19)

Conditions: SARS-CoV-2 Acute Respiratory Disease

Summary: a multicenter study, using prospectively collected, fresh (category i) and frozen (category ii), residual/leftover nasopharyngeal (np) swab in utm/uvt specimens obtained from symptomatic individuals suspected of covid-19 infection. this study will evaluate the neumodx sars-cov-2 assay's clinical performance on the neumodx 288 and neumodx 96 molecular systems.


Eligibility criteria:
inclusion criteria: 1. any de-identified np swab specimen in transport medium from a symptomatic individual suspected of covid-19 at the time of collection. 2. np swab specimens obtained using a flexible mini-tip flocked swab and collected into 3ml copan utm \[cat. no. 305c\] or bd uvt \[cat. no. 220531\]. 3. prospective specimens, fresh (category i) shall be tested within: 1. (4) hours when held at room temperature, or 2. (3) days when held at (2 to 8°c), with cold storage starting within (4) hours of collection. 4. minimum volume of ≥ 2ml. exclusion criteria: 1. required information unable to be obtained from the associated medical chart. 2. specimens that remained on-board the neumodx system for \> (8) hours prior to processing.
evaluate the efficacy and safety of oral hydroxychloroquine, indomethacin and zithromax in subjects with mild symptoms of covid-19

Conditions: COVID-19

Summary: currently there are no us food and drug administration (fda)-approved drugs specifically for the treatment of patients with covid-19. at present, clinical management includes infection prevention and control measures, as well as supportive care, including supplementary oxygen and mechanical ventilatory support when indicated. an array of drugs approved for other indications as well as several investigational drugs are being studied in several hundred clinical trials that are underway across the globe; however, currently there are no clinical trials available to patients in arizona. this study will determine if a specific drug cocktail can improve clinical outcomes in patients with confirmed mild sars-cov-2

covid-19 has become a massive threat to public health worldwide. current estimates suggest that the novel coronavirus (sars-cov-2) is both highly contagious (estimated reproductive rate, 2-3) and five to fifty-fold more lethal than seasonal influenza (estimated mortality rate, 0.5-5%); therefore, interventions to decrease the incidence and severity of covid-19 are emergently needed. in maricopa county there has yet to be a clinical trial to evaluate people who are sars-cov-2 positive with mild symptoms. this study will measure the improvement of covid-19 disease status as measured by time (days) required from initiation of treatment to improvement of clinical status from mild to symptom free on 14 days of a cocktail therapy of hydroxychloroquine, indomethacin and zithromax.

Eligibility criteria:
inclusion criteria: 1. \> 18 years of age 2. willing and able to provide written informed consent prior to performing study procedures 3. confirmed sars-cov2 infection by pcr 4. have mild symptoms of sars-cov2 5. must show documentation of sars-cov2 to screening visit 6. must have had recent hematology and chemistry results 7. must be able to take heart rate daily 8. must agree to skype/facetime daily 9. must agree to take temperature daily 10. must agree not to enroll in another study of an investigational agent prior to completion of day 14 of treatment. exclusion criteria: 1. known to be allergic to research drugs or drug excipients 2. incapable of providing informed consent 3. participation in any other clinical trial of an experimental treatment for sars-cov2 infection 4. pregnancy, possible pregnancy or breast feeding 5. prolonged qt interval (\>450) 6. moderate to severe symptoms of sars-cov2 7. renal failure 8. hepatic failure 9. nsaid use
regulatory post marketing surveillance study on yaz

Conditions: Contraception; Premenstrual Syndrome; Acne

Summary: the objective of this post marketing surveillance (pms) is to gain information about safety and efficacy in real practice.


Eligibility criteria:
inclusion criteria: * healthy female subjects * requesting contraception * suggesting pmdd by physician who are also requesting contraception * with acne who are also requesting contraception * age: 18 - 50 years * women who is prescribed yaz first, during study period exclusion criteria: * women who are contraindicated based on the label of yaz * presence or a history of venous or arterial thrombotic/ thromboembolic events (e.g. deep venous thrombosis, pulmonary embolism, myocardial infarction) or of a cerebrovascular accident * presence or history of prodromi of a thrombosis (e.g. transient ischaemic attack, angina pectoris) * history of migraine with focal neurological symptoms * diabetes mellitus with vascular involvement * the presence of a severe or multiple risk factor(s) for venous or arterial thrombosis may also constitute a contraindication * pancreatitis or a history thereof if associated with severe hypertriglyceridemia * presence or history of severe hepatic disease as long as liver function values have not returned to normal * severe renal insufficiency or acute renal failure * presence or history of liver tumours (benign or malignant) * known or suspected sex-steroid influenced malignancies (e.g. of the genital organs or the breasts) * undiagnosed vaginal bleeding * known or suspected pregnancy * hypersensitivity to the active substances or to any of the excipients

Keywords: contraception premenstrual dysphoric disorder pmdd acne
comparison of human embryo development using sequential and single media with time-lapse imaging

Conditions: Infertility

Summary: the purpose of this study is to compare human embryo in vitro development in sequential and single-step culture medium using time-lapse imaging.

objective: to study whether a culture medium that allows undisturbed culture supports human embryo development to the blastocyst stage equivalently to a well-established sequential media. design: randomized, double-blinded sibling trial. setting: independent in vitro fertilization (ivf) clinics. patient(s): one hundred twenty-eight patients, with 1,356 zygotes randomized into two study arms. intervention(s): embryos from each patient were randomly allocated into two study arms to compare embryo development on a time-lapse system using a single-step medium or sequential media.

Eligibility criteria:
inclusion criteria: * 6 or more normal embryos following egg retrieval and fertilization. * female patients aged 21-40 years or 21-55 years who are using an egg donor. * patients using fresh or frozen ejaculated sperm exclusion criteria: * previous history of cancer * day 3 embryo transfer

Keywords: embryo culture
randomized prospective trial: single port laparoscopic vertical sleeve gastrectomy versus conventional five port laparoscopic vertical sleeve gastrectomy surgery

Conditions: Obesity; Nutrition Disorders; Body Weight

Summary: vertical sleeve gastrectomy has been shown to significantly reduce weight and has been approved as a treatment of morbid obesity. the standard laparoscopic operation requires five small incisions for the introduction of instruments and the band into the patient's abdomen. the investigators have developed a technique for performing this operation through a single incision at the belly button. this study compares this method to the conventional 5-incision approach.


Eligibility criteria:
inclusion criteria: * bmi \>40 * asa i or ii exclusion criteria: * comorbid cardiac, pulmonary, renal, hepatic disease * bleeding disorder * previous gastric/esophageal surgery

Keywords: overweight obesity, morbid
mortality and related risk factors after hip arthroplasty

Conditions: Fracture of Neck of Femur (Hip); Femoral Head Necrosis; Dislocation of Hip Joint; Dysplasia of Hip Joint

Summary: the patients who underwent hip arthroplasty in our hospital from january 2017 to december 2020 were reviewed. the perioperative data were collected, and then the mortality was calculated and the risk factors were analyzed.


Eligibility criteria:
inclusion criteria: * all patients undergoing hip arthroplasty in renji hospital during 2017.1-2020.12 exclusion criteria: * patients who did not undergo surgery after admission age \< 18 years patients undergoing the second operation
laparoscopic versus open incisional hernia repair

Conditions: Postoperative Pain; Complications; Recurrence

Summary: primary closure of incisional hernia without the use of a mesh shows recurrence rates of up to 54%. if a mesh is used, the defect can be closed tension-free. using this method, recurrence rates have been reduced to 8-21%. laparoscopic correction of incisional hernia is a relatively new technique in which the mesh is positioned intraperitoneally. research has shown that this procedure is technical feasible and may have benefits for the patients. the ongoing debate about the merits of endoscopic versus open incisional hernia repair prompts the need for a level 1 randomized controlled trial.


Eligibility criteria:
inclusion criteria: * hernia diameter between 3 and 15 cm * location at the ventral abdominal wall at least 5cm from costae and inguinal area * indication for elective repair * age of 18 years or older * written informed consent. exclusion criteria: * contraindication for pneumoperitoneum * an absolute contraindication for general anesthesia * history of open abdomen treatment * patients participating in other trials

Keywords: operation time length of hospital stay
evaluation of prostate-specific membrane antigen (psma)-based pet imaging of primary prostate cancer

Conditions: Prostate Cancer

Summary: the objective of this study is to evaluate a radiolabeled urea-based small molecule inhibitor of prostate-specific membrane antigen (psma), \[18f\]dcfbc (dcfbc), as a pet imaging biomarker of prostate cancer detection and aggressiveness at initial diagnosis. psma is a well characterized histological marker of prostate cancer tumor aggressiveness but a quantitative non-invasive method for psma detection and monitoring is not currently available. development of such an imaging biomarker would be useful to differentiate indolent from aggressive prostate cancer phenotypes and allow for selection of appropriate risk adaptive therapies. the investigators preliminary first-in-human studies demonstrate high specific dcfbc uptake in metastatic prostate cancer and feasibility for prostate cancer imaging. the investigators propose to study patients initially diagnosed with biopsy-positive prostate cancer to determine if dcfbc uptake and location by pet imaging will be positively correlated with prostate cancer by prostatectomy tissue step-section analysis. dcfbc uptake at sites of suspected metastatic disease will be compared to conventional imaging modalities (ct, bone scan) and biopsy results when available. in addition, dcfbc-pet uptake quantification will be compared with expression levels of psma and other prostate cancer relevant markers (psa, ki-67, tmprss2-erg) by prostate tissue immunohistochemistry analysis and compared with clinical prognostic markers (psa, gleason score, clinical stage, partin tables derived prediction of pathologic stage).


Eligibility criteria:
inclusion criteria: 1. newly diagnosed prostate cancer pathologically proven by prostate biopsy 2. prostate biopsy histology grade ≥ gleason 3+3=6. 3. patients considered as candidates for and medically fit to undergo prostatectomy 4. at least 10 days after most recent prostate biopsy 5. no known problems with peripheral iv or central line access 6. able to tolerate urinary straight catheter placement 7. patient is judged by the investigator to have the initiative and means to be compliant with the protocol and be within geographical proximity to make the required study visits. 8. patients or their legal representatives must have the ability to read, understand and provide written informed consent for the initiation of any study related procedures. exclusion criteria: 1. prior pelvic external beam radiation therapy or brachytherapy 2. chemotherapy for prostate cancer 3. hormone deprivation therapy 4. investigational therapy for prostate cancer 5. hemorrhagic cystitis or active prostatitis 6. unable to lie flat during or tolerate pet/ct 7. prior history of any other malignancy within the last 2 years, other than skin basal cell or cutaneous superficial squamous cell carcinoma that has not metastasized and superficial bladder cancer 8. no prostatectomy scheduled prior to follow-up visit (12 to 72 hours post imaging) 9. serum creatinine \> 1.5 mg/dl or creatinine clearance \< 50 ml/min/1.73m2

Keywords: primary prostate cancer