Kornimate/medical-research-clean huggingface dataset:
establishment and validation of prediction model of simultaneous chemoradiotherapy for cervical cancer organoids

Conditions: Cervical Cancer Treated with Pelvic Radiotherapy; Cervical Cancers

Summary: this is a single-arm, single-center, open-label, phase ii study aimed at assessing the efficacy of organoids in predicting the response to radiotherapy and chemotherapy in cervical cancer

by constructing cervical cancer organoids, establishing a radiochemotherapy prediction model based on organoids, and exploring radiotherapy resistance-related molecules as new therapeutic targets for locally advanced cervical cancer, the feasibility and effectiveness are assessed. utilizing the constructed model for molecular mechanism discussions and effective drug screening, new avenues for the treatment of cervical cancer patients with radiochemotherapy resistance are sought.

Eligibility criteria:
inclusion criteria: able to understand and voluntarily sign written informed consent. 1. women aged ≥18 years at the time of study entry. 2. eastern cooperative oncology group performance status (ecog ps) score of 0-2.life expectancy ≥12 weeks. 3. histologically confirmed cervical cancer. 4. histologically-confirmed squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma，villous duct carcinoma, invasive mucinous multilayer carcinoma, gastric adenocarcinoma, mesrenal duct carcinoma, clear cell carcinoma, serous carcinoma, endometrioid adenocarcinoma and small cell carcinoma，intestinal-type adenocarcinoma of the cervix; 5. at least one measurable tumor lesion according to recist v1.1 criteria. 6. available archived tumor tissue samples or recent biopsies. 7. adequate organ function. 8. for fertile women with negative serum pregnancy and effective contraception within 7 days before administration (until 120 days after the last administration of the study drug and at least 180 days after radiotherapy) exclusion criteria: 1. subject with other active malignancies within 2 years prior enter the study. 2. subject who cannot receive brachytherapy. 3. active or prior documented autoimmune disease that may relapse. 4. history of interstitial lung disease or noninfectious pneumonitis. 5. subject with the clinically significant cardio-cerebrovascular disease. 6. history of severe hypersensitivity reactions to other mabs. 7. prior allogeneic stem cell transplantation or organ transplantation. 8. subjects who require systemic treatment with glucocorticoid (\>10 mg/day of prednisone or equivalent glucocorticoid) or other immunosuppressive agents within 14 days prior enter the study. 9. receipt of live attenuated vaccines within 30 days prior to the first dose of the study drug. 10. prior exposure to any experimental antitumor vaccines, or any agent targeting t-cell costimulation or immune checkpoint pathways (eg, anti-pd-1, anti-pd-l1, anti-pd-l2, anti-ctla-4, anti-cd137 or anti-ox40 antibody, etc). 11. any condition that, in the opinion of the investigator, would interfere with the evaluation of the study drug or interpretation of subject safety or study results. -

Keywords: cervical cancer concurrent chemoradiotherapy organoid
18f-dcfpyl pet/ct impact on treatment strategies for patients with prostate cancer

Conditions: Prostate Cancer

Summary: the main purpose of this phase ii trial study is to determine whether a positron emission tomography (pet)/computed tomography (ct) scan using 18f-dcfpyl affects the clinical management plan in veterans. in this study, the management plan prior to and after 18f-dcfpyl pet/ct will be recorded by specific questionnaires and corresponding changes in management will be analyzed. the scan will be used to see how the disease has spread. both the treatment strategies and probable disease outcomes as relevant to clinical endpoints will be assessed. this study is open to veterans only.


Eligibility criteria:
inclusion criteria: * participants who fulfill criteria for initial staging or restaging as outlined below: 1. initial treatment strategy decisions (initial staging) all participants with histologically proven prostate cancer or strong suspicion of prostate adenocarcinoma based on very high psa levels (\>50 ng/ml) who require an initial treatment/management decision who may be candidate for any of the following strategies: a) surgery b) external radiation therapy (rt) c) other focal therapies d) systemic medical treatment e) watchful waiting 2. assessment for subsequent treatment strategy (restaging), any of the following: a) participants with biochemical recurrence who are potential candidates for any salvage treatment. biochemical recurrence is defined by rising psa after definitive therapy with prostatectomy or radiation therapy, as any of the following: 1. post radical prostatectomy (rp): psa equals to or greater than 0.2 ng/ml measured more than 6 weeks after rp 2. post-radiation therapy : nadir + greater than or equal to 2 ng/ml rise in psa b) participants with known prostate cancer who undergo restaging because of new symptoms c) participants with known metastatic prostate cancer who undergo restaging because of rising psa with negative or inconclusive conventional imaging d) participants with known prostate cancer who are treated medically or with rlt in whom response to treatment is assessed * capability to provide written informed consent * able to remain still for duration of each imaging procedure (about 30 minutes) \* participants may be reenrolled in the study, if 18f-dcfpyl pet/ct is performed for subsequent management decision. exclusion criteria: * less than 18 years-old at the time of radiotracer administration * inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.) * any additional medical condition, serious concurrent illness, or other extenuating circumstance that, in the opinion of the investigator, may significantly interfere with study compliance. * inability to provide written informed consent

Keywords: prostate cancer pet/ct
pemetrexed/cisplatin intercalating gefitinib treating egfr wild nsclc

Conditions: Non Small Cell Lung Cancer

Summary: to investigate the curative effect between pemetrexed/cisplatin and pemetrexed/cisplatin intercalating gefitinib treating egfr wild nsclc

in preclinical data, it is identified that pemetrexed combined with erlotinib could achieve good response than pemetrexed because egfr-tki (erlotinib) could enhance the sensitivity of pemetrexed. so we design the trial to investigate curative effect between pemetrexed/cisplatin and pemetrexed/cisplatin intercalating gefitinib treating egfr wild nsclc.

Eligibility criteria:
inclusion criteria: 1.histological or cytological diagnosis of small-cll lung cancer histology 2.18 years or older 3.eastern cooperative oncology group (ecog) performance status no more than 2 4.local stage sclc without distant metastases 5.after 1st-line chemotherapy (ep or ip) at least 4 cycles 6.after radical radiotherapy for primary tumor and lymph node drainage area:including concurrent or sequence chemoradiotherapy 7.cr or pr assessment by recist(1.0) before randomized 8.haemoglobin 10.0 g/dl, absolute neutrophil count (anc) 1.5\^9/l, platelets 100 x 10\^9/l 9.total bilirubin 1.5 x upper limit of normal (uln) alanine aminotransferase (alt) and aspartate aminotransferase (ast) \< 2.5 x uln in the absence of liver metastases, or \< 5 x uln in case of liver metastases 10.creatinine clearance 60ml/min (calculated according to cockcroft-gault formula) exclusion criteria: 1. mixed non-small cell lung cancer histology 2. neck and supraclavicular lymph node metastasis 3. be allergic to temozolomide or intolerable to radiotherapy 4. any unstable systemic disease 5. pregnant or lactating women

Keywords: non small cell lung cancer gefitinib egfr negative pemetrexed
neonatologist-performed lung ultrasound in the delivery room

Conditions: Neonatal Disease

Summary: the objective of this study is to evaluate the role of the neonatologist-performed lung ultrasound (nplus) during immediate transition after birth of late preterm and full-term neonates using the lung ultrasound score to predict the need of respiratory support persisting more than 1 hour after birth.

lung ultrasound is an emerging clinical tool to assess the lung in a dynamic way. recently, the focus has been on establishing lung ultrasound in the neonatal intensive care unit (nicu) as a point-of care application. neonates born by a caesarean section are particularly prone to have an altered adaption to extrauterine life. especially in the first hours after birth, respiratory distress syndromes (rds) may occur due to delayed lung fluid clearance after birth. while acute rds in the first hours after birth may be a self-limiting disorder and therefore a benign condition, it remains difficult to identify neonates in need for further respiratory support at the nicu. admission to the nicu not only causes parental stress but also contributes to additional healthcare costs. there is emerging evidence that nplus is a reliable tool to differentiate between the causes leading to rds in neonates. using a neonatologist performed lung ultrasound score for the early identification of neonates in need of respiratory support persisting more than 1 hour would be therefore highly advantageous.

Eligibility criteria:
inclusion criteria: * late preterm neonates (born between 34 0/7 and 36 6/7 weeks of gestation) and full-term neonates (born later than 36 6/7 weeks of gestation) delivered by caesarean section * presence of any sign of respiratory distress (defined as tachypnoea/ dyspnoea, grunting, flaring of the nostrils or chest retractions) * written informed consent obtained from the parents prior to birth. exclusion criteria: * presence of cardiopulmonary malformations * patients with pneumothorax diagnosed by neonatologist-performed lung ultrasound

Keywords: neonatologist-performed lung ultrasound postnatal transition neonates
comt activity and hypnotizability

Conditions: Pain, Postoperative; Genetic Predisposition

Summary: hypnosis is an effective pain management tool for surgery that can reduce opioid use up to 40%. comt single nucleotide polymorphisms (snps) can predict pain sensitivity and opioid use perioperatively, and may also be associated with hypnotizability or response to hypnotic analgesia. analyzing comt haplotypes from dna extracted from saliva or blood using a giant magnetoresistive (gmr) nanotechnology platform may be faster, less expensive, and at least as accurate as pyrosequencing. this study aims to validate a multi-snp point-of-care (poc) gmr assay for the rapid genotyping of snps predictive of comt activity, and test the feasibility of using comt activity as a biomarker for hypnotizability and/or response to hypnotic analgesia.


Eligibility criteria:
inclusion criteria: * prior enrollment in one of 3 specific hypnosis trials * enrollment is by invitation only exclusion criteria: * participants in the prior trials who declined to be contacted for future research.

Keywords: hypnosis biosensing, technique pain, psychology analgesia,psychology hypnotizability giant magnetoresistive sensors
coveredge algorithm programming study

Conditions: Chronic Pain

Summary: this is a prospective, on-label, multi-center, non-randomized, exploratory, single-arm study to characterize the effects of programming features of the boston scientific precision spectra™ spinal cord stimulator (scs) system using the coveredge™ surgical lead.


Eligibility criteria:
inclusion criteria: * subject implanted, on-label, with a commercially approved boston scientific spectra neurostimulation system and at least one coveredge or coveredge x surgical lead, per local directions for use (dfu). * subject signed a valid, institutional review board (irb)-approved informed consent form. * subject is 18 years of age or older when written informed consent is obtained. exclusion criteria: * subject meets any contraindication in boston scientific (bsc) neurostimulation system local dfu. * subject is currently diagnosed with cognitive impairment, or exhibits any characteristic, that would limit study candidate's ability to assess pain relief or complete study assessments.

Keywords: stimulation implantable pulse generator back pain chronic pain leg pain
trial of pulse steroid therapy in kawasaki disease--pediatric heart network

Conditions: Cardiovascular Diseases; Heart Diseases; Infection; Coronary Aneurysm

Summary: the primary endpoint is coronary artery diameter, normalized for body surface area, 5 weeks after randomization. secondary endpoints include duration of fever, crp levels, and adverse events.

background: kawasaki disease (kd) is an inflammatory vasculitis of unknown etiology that affects infants and children and can cause coronary artery aneurysms. standard therapy consists of 2 gm/kg of intravenous immune globulin plus high-dose aspirin in the acute phase, and low-dose aspirin in the convalescent phase. some children do not respond to this therapy, and some children go on to develop coronary artery aneurysms in spite of aggressive treatment. this led to the design of this randomized controlled trial to compare a single dose of intravenous steroids vs. placebo on the background of standard therapy. recruitment began in december, 2002 and ended in december, 2004 with nearly 200 patients randomized. design narrative: this is a randomized controlled trial to compare a single dose of intravenous steroids vs. placebo on the background of standard therapy

Eligibility criteria:
* fever persisting at least 4 days and the presence of at least 4 of the following 5 principal features: 1. changes in extremities: acute changes include erythema and edema of hands and feet; convalescent changes include membranous desquamation of fingertips 2. polymorphous exanthema 3. bilateral, painless bulbar conjunctival injection without exudates 4. changes in lips and oral cavity: erythema and cracking of lips, strawberry tongue, diffuse injection of oral and pharyngeal mucosae 5. cervical lymphadenopathy ( 1.5 cm in diameter), usually unilateral; or * patients with at least four days of fever and coronary artery disease, defined as either: 1. having a z-score in either the proximal right coronary artery or the proximal left anterior descending coronary artery of \> 2.5 detected by 2-dimensional echocardiography, as well as: * for patients under six months of age, at least two principal criteria * for patients at least six months of age, at least three principal criteria. 2. meeting japanese ministry of health criteria for coronary aneurysm defined as an internal lumen diameter of \>3 mm in children less than 5 years of age or \>4 mm in children 5 years of age and older, in either the proximal right coronary artery or the proximal left anterior descending coronary artery and at least one principal criterion. and enrollment within ten days of the onset of illness, with day 1 defined as the first day of fever and informed consent of parents and assent of children who are older than age 7 years and capable of understanding or according to institutional guidelines.
a study of 2 doses of vaqta™ in healthy children 12 to 23 months of age (v251-069)

Conditions: Hepatitis A Virus Infection

Summary: this study will demonstrate the immunogenicity and evaluate the safety/tolerability of the vaccine in chinese children between 12 and 23 months of age.


Eligibility criteria:
inclusion criteria: * healthy chinese children 12 to 17 months old at receipt of the first study vaccination exclusion criteria: * subject is hepatitis a virus antibody positive at screening or has a history of hepatitis a infection * subject has a fever 72 hours prior to first injection * subject has already been vaccinated for hepatitis a * subject is allergic to aluminum, formaldehyde, sodium borate, latex, or any component of the vaccine * subject has received inactivated vaccines within 14 days of screening or live vaccines within 30 days of screening
interruption of maternal-to-infant transmission of hepatitis b by means of hepatitis b immune globulin

Conditions: Hepatitis B; Hepatitis, Viral, Human; Liver Diseases

Summary: to evaluate whether hepatitis b immune globulin with a high level of antibody against the hepatitis b antigen would be capable of interrupting maternal-fetal transmission of hepatitis b virus, the single most important route of hepatitis spread in the entire third world.

background: a baseline study on the vertical transmission of hepatitis b virus in taiwan revealed that 15 percent of all pregnant women were persistent carriers of hepatitis b antigen and that 40 percent of their new babies developed a protracted antigenemia during the first 6 months of life. the incidence of acute hepatitis, cirrhosis, and hepatoma was high in taiwan, and patients with these disorders had a fivefold to sixfold higher prevalence of hepatitis b antigen than healthy persons. given the important public health problems of this disease in taiwan and the rest of the third world, this trial sought to answer the important question of whether hepatitis b immune globulin with a high level of antibody against the antigen would be of utility in combating the problem. two hundred and five babies were accepted into the study, which was actually conducted on taiwan through a contract to the community blood council of greater new york. only those babies born of mothers who had hbsag complement fixation titers of 1:8 or greater were included in these studies. at birth, blood was obtained from the mothers and cord blood from the infants. follow-up bloods were obtained from both the mother and baby when the infants were 1, 3, 6, 12, 24 and 36 months of age. in addition, all household family contacts were bled at least once during this period. design narrative: randomized, double-blind, fixed sample. a total of 205 neonates were assigned to treatment with high-titer hepatitis b immune globulin, standard immune globulin, or albumin placebo within 72 hours of delivery. the study completion date listed in this record was obtained from the query/view/report (qvr) system.

Eligibility criteria:
boy and girl infants, birth to 3 years, born to mothers who were hepatitis b surface antigen carriers.
clinical performance of glass ionomer versus resin composite restorations

Conditions: Dental Caries

Summary: the aim of this randomised-controlled, single-blind, split-mouth, and single-centre clinical trial was to evaluate the 2-year clinical performances of a high-viscosity glass ionomer and nanohybrid composite resin in occlusal restorations on mandibular second molar teeth in patients at risk for salivary contamination.

occlusal carious lesions on the right and left mandibular second molars of 56 patients (26 females, 30 males) were restored in a split-mouth design. a high-viscosity glass ionomer (hv-gic) (equia, gc) was used to restore the carious lesions in patients in the treatment group, while a nano-hybrid composite resin (gso) (grandioso, voco) was used for patients in the control group. clinical evaluations of the restorations were performed at 1-week, 6-month, 1-year, and 2-year follow-up appointments, according to the fdi criteria. data were analysed using the friedman's analysis of variance and mann-whitney u tests (α=0.05).

Eligibility criteria:
inclusion criteria: * good health and oral hygiene, * occlusal carious lesions on both mandibular second molars, * mandibular second molars with mesial and occlusal contacts, * contraindication to the use of rubber dam, * the ability to return for periodic follow-up visits. exclusion criteria: * restoration on mandibular second molars.

Keywords: restorative glass ionomer
a study to assess the acute effects of vildagliptin on gastric emptying in patients with type 2 diabetes.

Conditions: Diabetes Mellitus, Type 2

Summary: please note this study is not being conducted in the united states. the purpose of this study is to assess the acute effects of vildagliptin, an unapproved drug, in reducing post-meal glucose levels by delaying gastric emptying.


Eligibility criteria:
inclusion criteria: * must be able to complete a 1-week wash-out of current anti-diabetic medications * cannot take any medications which may alter gastric motility except for cardiac medication at a stable dose * blood glucose criteria must be met * bmi \<40 exclusion criteria: * history of type 1 diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes * need for insulin within 3 months or patients on thiazolidinediones * significant concommitant disease or complications of diabetes * patients with any history of gastrointestinal surgery or positive gastrointestinal symptons * abnormal liver function tests as defined by the protocol * other protocol-defined inclusion/exclusion criteria may apply

Keywords: vildagliptin, type 2 diabetes, gastric emptying
seroprevalence of sars-cov-2 in the setting of a non-dedicated covid-19 hospital in a low cov-2 incidence area: implications for surgery

Conditions: Covid19; Surgery; SARS (Severe Acute Respiratory Syndrome)

Summary: we have herein analysed the patients admitted to our department that underwent serologic tests for sars-cov-2 either by ab or rt pcr, to estimate the prevalence of covid-19 in the setting of a non-dedicated covid-19 hospital and in a low cov-2 incidence area, and to evaluate if security measures are necessary for this context.


Eligibility criteria:
inclusion criteria: * patients hospitalized during pandemic spread exclusion criteria: * incomplete data

Keywords: sars-cov-2, surgery
results of 8 strand repair of flexor tendon injuries

Conditions: Cut Flexor Zone ll Using 8-strand

Summary: functional results of 8 strand repair of flexor tendon injuries zone ii with and without splinting of the wrist

flexor tendon injuries of the hand, account for 30% of all hand injuries, but are difficult to treat and are associated with frequent poor outcomes . while major progress has been made with the treatment of these injuries, current surgical treatment relies mostly on conventional suturing techniques with variable results, concluding in re-operation rates of 12%, and complication rate of up to 20% restoration of tendon gliding is the goal when repairing flexor tendon injuries. the tendon forces experienced during postoperative, active flexion exercises are significantly larger than the tendon forces experienced by patients engaging in only passive flexion. multistrand sutures (typically four- or six-strand repairs) may withstand much greater tension than conventional two-strand sutures during early active mobilization. however, multistrand (particularly eight-strand) repair requires complicated surgical skills; such repair is difficult. here, we present a new eight-strand suture for flexor tendon repair that features easier passages through the tendons and fewer knots than existing approaches; it affords the necessary tensile strength to prevent both gap formation and ultimate failure. the important aspects of flexor tendon repair are that the suture should have sufficient mechanical strength, and it should not result in a bulky configuration, which would affect tendon gliding . using the 8-strand repair technique and active mobilization performed by the patient is both practical and cost-saving. intensive supervision of a hand therapist is generally not required. notably improved outcomes have been achieved while preventing adhesions at the repair site.

Eligibility criteria:
inclusion criteria 1. adult patient 2. no fractures in the affected finger 3. thumb is excluded 4. duration of injury less than 2 weeks exclusion criteria: -