Kornimate/medical-research-clean huggingface dataset:
temozolomide phase ii clinical study in patients with newly diagnosed glioblastoma multiforme (study p04661)(completed)

Conditions: Glioblastoma

Summary: the purpose of this study is to evaluate the safety of combination therapy of radiotherapy and temozolomide ("concomitant radiotherapy phase"), and then temozolomide monotherapy ("monotherapy phase"), in patients with newly diagnosed glioblastoma multiforme. progression free survival and response rate will also be calculated.


Eligibility criteria:
inclusion criteria: * histopathologically confirmed newly diagnosed glioblastoma multiforme with who grade iv. * histological diagnosis must be made locally after biopsy or neurosurgical tumor resection. * four or more unstained tissue sections or a paraffin block must be provided to the pathological judgment committee as tissue specimens. * initial surgery/biopsy at diagnosis performed \<=6 weeks (42 days) prior to treatment with temozolomide. * age: \>=18 and \<=70 years. * ecog performance status \<=2. * stable, non-increasing dose of corticosteroids over the 14 days prior to treatment with temozolomide. * no prior chemotherapy or radiotherapy. * laboratory test values obtained within 14 days before initiation of administration of temozolomide must satisfy the following criteria: * absolute neutrophil count \>= 1500/mm\^3; * platelet count \>= 100,000/mm\^3; * serum creatinine \<=1.5 times the upper limit of laboratory normal; * total bilirubin \<=1.5 times the upper limit of laboratory normal; * glutamic oxaloacetic transaminase or glutamic pyruvic transaminase \<2.5 times the upper limit of laboratory normal; * alkaline phosphatase \< 2.5 times the upper limit of laboratory normal. * absence of pathological conditions that interfere with taking oral drugs. * contraception during the study period (from informed consent to the day of the last observation/examination of this study) is required in sexually active, potentially fertile patients, regardless of sex, under the supervision of the investigator or sub-investigator. * the investigator and/or subinvestigator must judge that life expectancy is 12 weeks or more. * patients may be included regardless of sex or inpatient/outpatient. exclusion criteria: * extensively disseminated glioblastoma multiforme. * severe disorders in the heart, liver, kidney, blood, etc. * presence of previous or concurrent malignancies at other sites with the exception of surgically cured carcinoma in-situ of the cervix and non melanoma skin cancer. * women who are pregnant or lactating. * women who may be pregnant or who could become pregnant and do not adopt contraception method(s). * participation in another clinical study within 6 weeks prior to the initiation of administration of temozolomide. * subjects who the investigator and/or subinvestigator judged inappropriate to participate in the study.
effect of pterygium excision on intraocular lens power calculation for subsequent cataract operation

Conditions: Pterygium; Cataract; Astigmatism

Summary: pterygium is known to induce with-the-rule astigmatism. excision of pterygium will steepen the cornea and reduce corneal astigmatism. we postulate that the alteration of keratometry reading will indirectly affect the iol power calculation in cases with concurrent pterygium and cataract. concurrent pterygium and cataract is common in hong kong and other tropical regions. the effect of pterygium excision on intraocular lens power calculation is investigated.


Eligibility criteria:
inclusion criteria: * all cases with concomitant cataract and primary pterygium, which are indicated for surgery. exclusion criteria: * pterygium smaller than 1mm, which is not visually significant. * double headed pterygium * pterygium obscuring visual axis that preclude keratometry or autorefraction measurements. * previous corneal refractive surgery that alter the keratometric power of the cornea. * patients with medical problems that preclude staged ocular surgery, e.g. dementia, heart disease, on warfarin.

Keywords: pterygium cataract astigmatism
uc-msc transplantation for left ventricular dysfunction after ami

Conditions: Left Ventricular Dysfunction; Acute Myocardial Infarction

Summary: a pilot study to evaluate the safety and feasibility of umbilical cord mesenchymal stem cells in the treatment of acute myocardial infarction by catheter transplantation

in this study, 40 patients with cardiac insufficiency after acute myocardial infarction were selected and randomly divided into umbilical cord mscs transplantation treatment group and non-intervention control group to preliminarily observe the safety and effectiveness of mscs cell transplantation treatment.

Eligibility criteria:
inclusion criteria: * patients with acute extensive anterior myocardial infarction were successfully treated with emergency interventional therapy within 12 hours after onset. lvef was less than 0.35 by echocardiography 30 days after operation, scar area was more than 25% by mri, and cardiac function was nyha iii-iv grade. * fully inform the purpose, method and possible side effects of the test, agree to the test, and sign an informed consent form; * good compliance, willing to take drugs and follow up according to the requirements of the plan; * life expectancy exceeds one year. exclusion criteria: * those who cannot tolerate cell therapy; * patients with severe hepatic and renal insufficiency (alt\>1.5 times the upper limit of normal value, cr \>1.5 times the upper limit of normal value); * patients with malignant tumors or extremely weak patients; * patients with severe infection; * patients who are expected to have the second coronary intervention or bypass grafting within 3 months; * patients with other serious systemic diseases and organ dysfunction; * patients with cardiogenic shock; * patients with hemorrhagic diseases; * researchers believe that anyone who is not suitable for inclusion

Keywords: ami
efficacy of serratus posterior intercostal plane block for analgesia and inflammatory marker in breast surgery

Conditions: Breastcancer; Perioperative Pain; Inflammation

Summary: to study the efficiacy of serratus posterior superior block in controlling perioperative breast cancer surgery pain and its effect on inflamatory markers.

back ground the presence of pain during the initial course of treatment in women with early-stage breast cancer was associated with significantly higher levels of c-reactive protein(crp) ,interleukin-7(il-7)and interleukin-13(il-13) there is evidence of effectiveness of regional block in controlling inflamatory markers serratus posterior superior intercostal plane block (spsipb) is a novel regional technique that provides analgesia in the hemithorax, shoulder, and back of the neck which proved its efficacy in controlling pain after video assisted thoracoscopic surgery there are little epidemiological data on (spsipb)usage in masectomy and lumpectomy procedures and its effect on inflamatory markers methodology: * type of the study: randomized prospective comparative controlled double-blinded study * study setting: ain shams university hospitals * study period: one year after approval of the protocol. * place :ain shams university hospitals * study population: adult patients who will undergo breast cancer surgey.

Eligibility criteria:
inclusion criteria: * adults undergoing unilateral breast surgery under general anesthesia * age 21 to 60 years with body mass index (bmi)=18 to 25 kg/m2 * american society of anesthesiologists (asa) grade i-iii. exclusion criteria: * patients with long-time use of analgesic drugs * past history of chest surgery, * allergy to local anesthetics, * systemic infection, * cognitive and language disorders precluding participation, * patients with coagulopathy,anticoagulant users * hemodynamic unstable patients * patients with neurology, spinal, psychiatry diseases * infection at block site * patients refused to participate in the study .
assessing the validity of the pap problems triage tool in patients with pap treatment for obstructive sleep apnea

Conditions: Obstructive Sleep Apnea (OSA)

Summary: the intended use of the positive airway pressure (pap) problems triaging tool (tt) is to appropriately triage patients with a pap-associated problem(s) to a specific intervention(s) based on patient responses. thus, the proposed research will validate the tool, determine optimal scoring thresholds, and explore the utility of the tool as an indicator for intervention. our central hypothesis is that the pap problems tt will identify treatment barriers that if unaddressed, are predictive of treatment non-adherence.

this study is a one-group observational design that uses a tt questionnaire and abstraction of pap use data from a clinically available interface (somnoware™). consecutive adults with osa and recommended to pap treatment at the fontana medical sleep center will be invited to the study. once the patient has been prescribed pap therapy and has indicated their willingness to participate the tt will be sent digitally from somnoware™. participants will receive the tt in accordance to the next time interval defined by the study protocol. a randomly selected sub-group of participants will automatically receive an animated education video delivered digitally from somnoware™. these videos will provide targeted information for self-managing the endorsed pap problem. diagnostic polysomnogram (psg) or home sleep apnea test (hsat) data will be abstracted from somnoware™. daily pap data will be abstracted from somnoware™ for the first 35-days of pap use. demographic data will also be abstracted at day 35 (from the patient's clinical intake questionnaire and electronic health record).

Eligibility criteria:
inclusion criteria: * kaiser permanente member (kp insured) * osa diagnosis by polysomnogram or home sleep apnea test with apnea hypopnea index ≥ 15 events/hour * pap naïve * able to consent to participate * fluent or proficient with english * accepts pap for home treatment exclusion criteria: * chronic respiratory failure requiring oxygen supplementation * pap device other than a pap or autopap (i.e., bilevel pap) * pregnant

Keywords: positive airway pressure (pap) therapy triaging tool pap problems pap adherence
pneumacrit device for neonatal cardio respiratory monitoring

Conditions: Neonatal Respiratory Distress

Summary: the usability of a new pneumacrit system is studied in clinical environment in this feasibility study.

electrical impedance tomography is a noninvasive monitoring tool for neonatal lung aeration and breathing. this feasibility study will assess the usability of a new pneumacrit electrode belt in clinical environment.

Eligibility criteria:
inclusion criteria: * inpatient at oulu university hospital picu or nicu * gestational age at birth over 32 weeks * weight 2000-5000g * postnatal age \> 12 hours * written informed consent from the parents of legal representative * non-invasive monitoring of oxygen saturation and ecg exclusion criteria: * postmenstrual age \< 32 weeks * weight at time of the study \ 5000g * chest skin lesion preventing safe use of the electrode belt * recent chest surgery within the past 7 days (e.g. thoracotomy)

Keywords: electrical impedance tomography, neonate
swiss childhood health and nutrition survey 2023

Conditions: Childhood Obesity

Summary: this study will repeat previous studies done in 2002, 2007 2012 and 2017/18, in order to monitor the trend in the prevalence of overweight and obesity in 6-12 year old children in switzerland over the entire period. furthermore, additional risk factors will be assessed for the later development of ncd using a questionnaire comparable to the one used in 2017/18.

a total of ca. 2500 children will be recruited throughout switzerland and their height, weight, waist circumference as well as percentage body fat will be measured. in addition, children will be asked to complete a questionnaire on some aspects of their diet, physical activity, health and socioeconomic background. data will be compared to previous surveys conducted since 2002 to monitor trends in overweight and obesity prevalence in switzerland. the results from the questionnaire will be used to investigate risk factors for obesity and the later development of ncds.

Eligibility criteria:
inclusion criteria: * age between 6 and 12 years exclusion criteria: * none
gallbladder functions & serum cholecystokinin levels in women diagnosed with hyperemesis gravidarum

Conditions: Hyperemesis Gravidarum; Pregnancy Related

Summary: this study evaluates the gallbladder functions and serum cholecystokinin levels in pregnant women diagnosed with hyperemesis gravidarum. half of the participants are healthy pregnant women and half of the participants are pregnant women diagnosed with hyperemesis gravidarum. two groups will be compared by means of gallbladder functions and serum cholecystokinin levels.

previously gallbladder functions have been observed in human with gallbladder disease. however it has never been evaluated whether there is any difference in gallbladder functions between healthy pregnant women and pregnant women diagnosed with hyperemesis gravidarum. moreover correlation between hyperemesis gravidarum symptom scores and gallbladder functions has never been assessed. there is also few data comparing serum cholecystokinin levels between healthy pregnant women and those diagnosed with hyperemesis gravidarum. the investigators will measure serum cholecystokinin levels after a fatty meal (100 g chocolate) and compare two groups. in this study the investigators would like to evaluate gallbladder functions and serum cholecystokinin levels in women with hyperemesis gravidarum and compare these with healthy subjects.

Eligibility criteria:
inclusion criteria: * gestation week between 6 and 14 weeks, * singleton pregnancy with a live embryo, * healthy women without any medical disorders, exclusion criteria * any systemic disease, * gallbladder disease * any psychological disorder that can cause vomiting, * multiple gestation

Keywords: gallbladder functions cholecystokinin hyperemesis gravidarum
hospital-based surveillance to collect prospective data to estimate the disease burden of severe rv ge in sweden

Conditions: Rotavirus Gastroenteritis; Infections, Rotavirus

Summary: this study aims to estimate the burden of rv ge. the study will focus on children hospitalized for severe rv ge, children acquiring rv ge in the hospital and the household contacts of children hospitalized with rv ge. it is expected to enrol 500-600 subjects in the study. the protocol posting has been updated in order to comply with the fda amendment act, sep 2007.


Eligibility criteria:
inclusion criteria: * written informed consent obtained from parent or guardian * a male/ female child aged less than 5 years. on the day of fifth birthday the subject is not eligible for participation * hospitalised for acute ge * developed symptoms of acute ge 72 hours after hospitalisation * stool sample should be positive for the presence of rotavirus, which will be detected either by vikia test or by elisa inclusion criteria for household members: * family members including care-takers and sibling staying in the same house and who spend most of the nights (50%) with the sick child. * written permission from care-takers or siblings or their parents. exclusion criteria: - all children in the neonatal wards.

Keywords: rotavirus gastroenteritis
retrospective analysis of patients with metastatic renal cell carcinoma treated with cabozantinib

Conditions: Metastatic Renal Cell Carcinoma

Summary: cabogen is a observational, retrospective, multicenter study that will enroll patients with metastatic clear cell renal carcinoma (mccrcc) treated with cabozantinib after one or more previous lines of treatment that included tkis, immune checkpoint inhibitors or mtor inhibitors.

the aim of this study is to describe the genomic profiling of patients with metastatic renal cell carcinoma (mrcc) who are long-lasting responders to treatment with cabozantinib and patients who are not long-lasting responders to the cabozantinib treatment. the study plan to enroll about 80 patients in 10 italian centers: group a: 40 patients defined as long-lasting responders (pfs ≥ 9 months) group b: 40 patients defined as primary refractories to cabozantinib (pfs ≤ 3 months) tissue samples from nephrectomy or from a metastatic site will be used to perform genomic profiling not older than 5 years.tissue should be formalin-fixed, paraffin-embedded (ffpe). genomic profiling will be performed with a hybrid capture-based next-generation sequencing assay (foundationone). the sample will be assayed for all coding exons of 324 cancer-related genes plus select introns from 34 genes that are frequently rearranged in cancer. sequencing will be performed to a mean exon coverage depth of \>500x. the resulting sequences will be analyzed for all classes of genomic alteration, including short variant alterations, copy number alterations, and selected gene fusions or rearrangements.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years. * patients with histological diagnosis of predominantly clear cell carcinoma * availability of the tumor tissue from the primary tumor and/or a metastatic site for the genomic profiling analysis not older than 5 years. * evaluable disease according to recist criteria v 1.1 * treatment with cabozantinib after one or more previous therapies for mrcc * patient progressed from the start to cabozantinib therapy within 3 months or after 9 months * any prognosis group according to the imdc risk score * signed informed consent must be obtained for living patients. patients who died and patient untraceable will be analyzed based on the authorization no. 9/2016 of the italian data protector supervisor. exclusion criteria: * non-availability of tumor tissue from the primary tumor or a metastatic site for biomarker analysis * patient progressed between 3 and 9 months from the beginning of treatment with cabozantinib. * non-availability of clinical information useful to evaluate the imdc risk group at baseline.

Keywords: metastatic renal cell carcinoma genomic signature long lasting response cabozantinib treatment
epidemiology and long-term outcome of patients with vhd

Conditions: Valvular Disease; Valvular Heart Disease; Aortic Valve Stenosis; Mitral Insufficiency and Aortic Stenosis; Mitral Stenosis; Coronary Artery Disease; Chronic Kidney Diseases

Summary: valvular heart diseases are significant problem in polish population. coexistence of coronary artery disease in patients with vhd increases the risk of death and affects further therapeutic strategy. the aim of the study is analysis the epidemiology and the long-term prognosis among patients with vhd.

valvular heart diseases are significant problem in polish population. coexistence of coronary artery disease in patients with vhd increases the risk of death and affects further therapeutic strategy. patients with moderate and severe valvular heart diseases are included into the study. the set of variables subject to interpretation consisted of demographic data, medical history, result of coronary angiography, and type of applied percutaneous and surgical treatment

Eligibility criteria:
inclusion criteria: * valvular heart disease in moderate and severe stages exclusion criteria: * age \< 18 years old

Keywords: valvular heart disease aortic valve stenosis mitral insufficiency coronary artery disease chronic kidney diseases
safety, tolerability and immunogenicity of hpv (human papilloma virus) vaccine in healthy females 9 to 15 years of age in india (v501-029)

Conditions: Papillomavirus Infections

Summary: the purpose of this study is to evaluate the safety and tolerability of the quadrivalent human papilloma virus (hpv) vaccine in healthy females 9 to 15 years of age in india. quadrivalent hpv vaccine is composed of l1 virus-like particles (vlps) from hpv types 6, 11, 16, and 18.


Eligibility criteria:
inclusion criteria: * healthy females age 9 to 15 years * females not sexually active and not plan on becoming sexually active during the study * no fevers 24 hours prior to the first injection exclusion criteria: * participant had received a prior vaccination with a hpv vaccine * participant has allergies to vaccine component including aluminum and yeast * participant has (human immunodeficiency virus) hiv infection * participant is immunocompromised * participant received or plans to receive blood-derived product within 6 months prior to the first injection * participant received or plans to receive immune globulin preparation within 6 months to the first injection
prospective assessment of robotic sacrocolpopexy: a european multicentric cohort (parsec)

Conditions: Pelvic Organ Prolapse

Summary: the purpose of this study is to prospectively assess the outcomes of robotic sacrocolpopexy for repair of pelvic organ prolapse in high volume european centers.

to prospectively assess the outcomes of robotic sacrocolpopexy for repair of pelvic organ prolapse in high volume european centers. primary outcome: anatomical cure rate (using simplified pop-q staging system) secondary outcomes: complication assessment (clavien-dindo), functional results, intraoperative variables, impact of surgery on quality of life (pfiq-7, pisq-12)

Eligibility criteria:
inclusion criteria: * symptomatic vaginal vault prolapse with simplified pelvic organ prolapse quantification (pop-q) stage 2 or greater exclusion criteria: * poor health status with inability to undergo general anaesthesia * age \< 18 years * ≥ 3 previous laparotomic surgeries * planned pregnancy * other: known pelvic malignancies, previous pelvic radiotherapy, congenital anomalies of genitourinary tract, autoimmune diseases with connective tissue involvement (lupus, sjogren sdr, sclerodermia, etc.), current uti's, use of steroids, anticoagulants, interstitial cystitis

Keywords: pelvic organ prolapse pop sacrocolpopexy sacrohysteropexy promontofixation colpopexy robotic surgery surgical complications mesh prolapse repair
diagnosis of metastatic tumors on 68ga-fapi pet-ct and radioligand therapy with 177lu-eb-fapi

Conditions: 177Lu-EB-FAPI

Summary: fap is a fibroblast activation protein and overexpressed in many tumor tissues. this study is intended to conduct preliminary clinical transformation and internal irradiation dosimetry research on 177lu-eb-fapi--a new 177lu therapeutic drug modified by evans blue (eb) for the first time in the world.

fibroblast activation protein (fap) is a serine peptidase on the surface of tumor associated fibroblasts. it belongs to type ii transmembrane glycoprotein. it is rich and characteristic expressed in tumor associated fibroblasts. it has special biological characteristics and stable genome. fap is expressed at a high level in mesenchymal cells during the embryonic period and is inhibited shortly after birth. it is usually not expressed or expressed at a low level in the resting tissues of normal adults, but it is highly expressed in diseases related to tissue repair and matrix reconstruction, such as wound healing, inflammatory response, fibrosis and cancer it plays an important role in metastasis and immunosuppression.currently, 68ga labeled fapi (68ga-fapi) has been successfully applied to a variety of tumor pet/ct imaging, including lung cancer, breast cancer, and gastrointestinal tract tumors.by modifying fapi with evans blue (eb) to form a new eb-fapi, endogenous albumin can be used as a reversible carrier to prolong the retention time of drugs in the blood, thus increasing the targeted aggregation and retention of 177lu-eb-fapi in tumor cells, and effectively killing a variety of transplanted tumors with positive fap expression.we'll try to assess the safety and therapeutic response to 177lu-eb-fapi in patients with metastatic tumors in human.

Eligibility criteria:
inclusion criteria: * confirmed treated or untreated metastatic tumors patients; * 68ga-fapi pet/ct and 18f-fdg pet/ct within two weeks; * signed written consent. exclusion criteria: * pregnancy; * breastfeeding; * any medical condition that in the opinion of the investigator may significantly interfere with study compliance