Kornimate/medical-research-clean huggingface dataset:
study to evaluate eupolio(ipv)'s safety, long-term protective effect and boosting effect of one booster dose in the three primary vaccination plus boosting schedule, and protective effect in the schedule with bivalent opv in infants

Conditions: Poliomyelitis; Vaccine Reaction

Summary: eupolio is inactivated poliovirus vaccine (ipv). major purpose of this study is to evaluate safety of eupolio in 2,000 infants. in addition to the safety, long-term protection after completion of the three primary vaccinations and extent of protective level after a single boosting dose of eupolio will be evaluated. as ipv plus bopv vaccination schedule (3 doses of bopv plus 2 doses of ipv in infant-toddle vaccination schedule) has been implemented in some countries, this study will also evaluate eupolio's safety and protective effect in that schedule.


Eligibility criteria:
inclusion criteria: * infants in stable health * male or female 6 to 8 weeks of age * signed informed consent by the infant's parent(s) or legally acceptable representative(s) exclusion criteria: * known or suspected poliomyelitis * known or suspected febrile(symptom of a fever), or chronic illnesses * fever ≥ 38.0℃/100.4℉ within 3 days prior to study registration or intake of drug preventing fever * known or suspected immune disorders (abnormal activity in protective system in human body) or received immunosuppressive therapy (treatment for weaken protective system in human body) * previous use of blood or blood-derived products * previous use of polio vaccines * seizures (temporary abnormalities in muscle tone or movements due to abnormal activity in the brain) * bleeding disorders * household contact or intimate exposure with a confirmed case of polio * any history of allergy (hypersensitivity) to the components of the polio vaccine * participation in another interventional clinical trial simultaneously or within 30 days
effects of preconditioning with sevoflurane during organ procurement from brain dead donors: impact on early function of liver allografts

Conditions: Post-transplantation Liver Allograft Function

Summary: the aim of the investigators study is to investigate the effects of anaesthetic preconditioning with sevoflurane during organs harvesting in brain dead donors. more particularly, the investigators will investigate whether sevoflurane preconditioning protects against ischaemia-reperfusion the livers and kidneys allografts after a prolonged period of cold ischaemia and whether this protection translates in a better clinical functional recovery of these allografts.


Eligibility criteria:
inclusion criteria: * all consecutive brain dead donors in the belgian university hospitals of leuven, brussels, louvain and liège eligible for organs harvesting followed by organs transplantation in the eurotransplant area. there is no age limitation for eligibility exclusion criteria: * haemodynamic instability that precludes safe administration of 2% sevoflurane.

Keywords: anesthetic preconditioning sevoflurane liver transplantation brain-death donors
study of a controlled release formulation of pregabalin in fibromyalgia patients

Conditions: Fibromyalgia

Summary: the purpose of this study is to evaluate the efficacy and safety of a controlled release formulation of pregabalin administered once daily as compared to placebo in the treatment of fibromyalgia. all patients will receive pregabalin; half of the patients will receive placebo at some point in the study.


Eligibility criteria:
inclusion criteria: * patients must have fibromyalgia. exclusion criteria: * patients with other painful conditions cannot participate.

Keywords: fibromyalgia pain pregabalin lyrica
study on early lyme neuroborreliosis

Conditions: Nervous System Lyme Borreliosis

Summary: the purpose of this study is to determine clinical course and the sequelae of early lyme neuroborreliosis after treatment with ceftriaxone.


Eligibility criteria:
inclusion criteria: * erythema migrans within 4 months before neurologic involvement and pleocytosis in patients \>15 years old exclusion criteria: * pregnancy * lactation * history of adverse reaction to a beta-lactam antibiotic

Keywords: lyme neuroborreliosis
time-restricted feeding for treating polycystic ovary syndrome (pcos)

Conditions: Polycystic Ovary Syndrome; Overweight; Obesity

Summary: intermittent fasting is an increasingly popular diet pattern of alternating eating and dieting.one particular form of intermittent fasting is the so-called time-restricted feeding (trf). trf allows for ad libitum feeding within a large window of time each day, and does not require any calorie counting. there is growing evidence that it can lose weight, reduce insulin resistance and improve cardiometabolic health. polycystic ovary syndrome (pcos) is the most common reproductive endocrine and metabolic disease affecting women of childbearing age. pcos shows anovulation or oligoovulation, hyperandrogenemia and ovarian polycystic changes. insulin resistance and obesity are common features of pcos. whether the trf impacts women with pcos is still unknown due to the paucity of data in this area. to explore the effects of trf on the endocrine and metabolic profile in overweight women with pcos, a 6-week single-arm trial, divided into 2 consecutive periods: (1) 1-week baseline period; and (2) 5-week trf period, will be implemented.


Eligibility criteria:
inclusion criteria: age ≥ 18 years; bmi≥24kg/m2; anovulation; rott-pcos. exclusion criteria: taking weight loss or regulate hormone secretion medications in recent 6 months; the body weight fluctuated more than 5% in the past 3 months; preparation for pregnancy, having been in pregnancy or lactation; perimenopausal; night-shift workers; fasting more than 16 hours a day; hypotension; patients with other diseases (such as congenital adrenal hyperplasia, cushing syndrome, androgen-secreting tumors, hyperprolactinemia, diabetes, thyroid diseases, severe serious cardiovascular, gastrointestinal, kidney or liver diseases); alcohol intake more than 100g per week; smoking within 3 months; engaging in high-intensity exercise.
effects of ketamine on human bladders and its possible mechanisms

Conditions: Cystitis

Summary: this study is aimed to evaluate the relationship between ketamine abused and bladder dysfunction and its possible mechanisms.


Eligibility criteria:
inclusion criteria: * adult male or female * cystitis (the clinicians ruled out the causes of bacterial infection) * frequent micturition * the clinicians are willing to sign the icf exclusion criteria: * suffers from the urinary system disease, is not suitable to carry on the urinary bladder biopsy sampling * suffers from other diseases, doctor recognized that is not suitable to carry on the sampling * the clinicians are not willing to sign the icf

Keywords: ketamine bladder dysfunction bladder mucosa mechanisms
evaluation of pd-l1 (programmed death-ligand 1) tumor expression in patients with large-cell neuroendocrine carcinoma (nec)

Conditions: Large Cell Lung Cancer; Neuroendocrine Carcinoma of Lung (Diagnosis)

Summary: observational, multicentre, retrospective study on patients taken care according to the national guidelines. the objective is to define, after the diagnosis confirmation, the frequency of pd-l1 expression in patients with large-cell lung neuroendocrine carcinoma (nec), whatever the stage of the disease, and to correlate this parameter to clinical data at the time of diagnosis, therapeutic response and survival. large-cell necs present a bad prognostic and there is no evidence of treatment for these patients with advanced disease in second ligne of treatment at that time. to demonstrate the pd-l1 expression in this type of cancer might have a major therapeutic impact in a close future to access immunotherapies.


Eligibility criteria:
inclusion criteria: * patients aged \> or = 18 years * diagnosis of large-cell nec confirmed by centralised reading * tumoral materials available and readable for pd-l1 labeling exclusion criteria: * other type of lung cancers * tumoral material not available or not readable for centralised reading * tumoral material not available or not readable for pd-l1 labeling
mri staging in colon cancer

Conditions: Colon Cancer

Summary: the main purpose of this study is to investigate whether magnetic ressonance imaging (mri) can be used in treatment planning with assessment of diagnostic accuracy. with the inclusion of 150 patients the study will investigate whether mri is useful and better than ct scanning in patients with colon tumors. and also if mri is useful after neoadjuvant treatment.

colon cancer is a frequent disease in denmark with over 3200 new cases and about 1350 deaths per year. ct scanning is currently the national standard method for determining the stage of disease planning for treatment. ct scan can sufficiently distinct between minor and advanced colon tumors. prevalence of advanced tumors was well over 40% in the ct study from vejle hospital in 2013. sensitivity and specificity of detection of advanced colon tumors in the ct study was approx. 70% and 80%, respectively. a small mri pilot study showed higher sensitivity and specificity of 89% and 96%, respectively. mri scan is currently performed in most patients with rectal cancer, which has resulted in better treatment planning and increased survival. mri scan of the rectum is documented with higher accuracy than ct scan. there has been reluctance to introduce mri scan in patients with colon cancer, as the colon has more peristalsis than the rectum, and movement of the bowel can result in image quality reduction in mri. however, in recent years mri has become faster and thereby less sensitive to movements. mri scanning may in the future help to select the patients who will benefit from neoadjuvant treatment. in addition, with mri it is possible to perform mri diffusion measurements of the tumor, which gives an estimate of the tumor's cell density. it will also be possible to investigate whether this changes the mri diffusion restriction during the neoadjuvant treatment. this study is prospective and uses state of the art equipment with a 3 tesla mri unit. the main purpose of the study is to investigate whether mri can be used in treatment planning with assessment of diagnostic accuracy. with the inclusion of 150 patients the study investigates whether mri is useful and better than ct in patients with colon tumors. and also if mri is useful after neoadjuvant treatment.

Eligibility criteria:
inclusion criteria: * diagnosed with colon cancer * 18 years old or older * written and verbally informed consent exclusion criteria: * pacemakers, implanted medical pumps, and nerve stimulators * cochlea implants and cerebral aneurism clips will in some cases be absolute contraindications to mri examinations. * previous treatment with radiation and or chemotherapy * serious disease that contraindicates surgical treatment, including severe heart disease * any type of cancer other than of the colon (excluding skin cancer, cancer in situ, endometrial cancer, malignant melanoma) * any other condition or disease that from the investigator's point of view makes it inappropriate for the patient to participate.
clinical comparison of different glass ionomer-based restoratives and a bulk-fill resin composite in class i cavities: a 48-month randomized split-mouth controlled trial

Conditions: Class I Dental Caries

Summary: the aim of this study is to compare the clinical performances of high-viscosity glass ionomer (gi), glass carbomer (gc), zirconia-reinforced gi (zir), and bulk-fill (bf) composite resin restorations.for this purpose, two calibrated operators placed 128 restorations in 30 patients with a mean age of 21 years. the restorations will be evaluated by one examiner at baseline and at 6, 12, 18,24, and 48 months using the modified us public health service criteria. the data will statistically analyzed.


Eligibility criteria:
inclusion criteria: * patients presenting 1) at least four single-surface occlusal caries on their posterior molar teeth (first and/or second molars); 2) teeth to be restored had to be vital and without pulpal or periodontal disease, pain, and preoperative sensitivity; 3) teeth should be in occlusion; and 4) must agree to come to follow-up appointments. exclusion criteria: * patients with 1) poor oral hygiene, serious health problems, and/or heavy bruxism; 2) partly erupted teeth; 3) absence of adjacent and antagonist teeth; 4) teeth with interproximal caries; and 5) inability to attend recalls.

Keywords: glass ionomer cements bioactive materials
a study of ctx-009 (abl001) in combination with irinotecan or paclitaxel in advanced or metastatic solid tumor patients

Conditions: P1b: Advanced Solid Tumors; P2: Biliary Tract Cancer

Summary: this study is a phase 1b/2 multi-center study to assess the safety, tolerability, pharmacokinetics of ctx-009 (abl001) in combination with irinotecan or paclitaxel in patients with advanced or metastatic solid tumors.

phase 1b study: indication of phase 1b study is the advanced or metastatic solid tumors (including, but not limited to, colorectal cancer, gastric cancer, and ovarian cancer). phase 2 study: indication of phase 2 study is unresectable advanced, metastatic or recurrent biliary tract cancer (btc) (including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, gallbladder cancer, and ampullary carcinoma).

Eligibility criteria:
key inclusion criteria: * p1b only: patients with histologically or cytologically confirmed metastatic or unresectable advanced solid tumors * p2 only: patients with histologically or cytologically confirmed unresectable advanced, metastatic, or recurrent biliary tract cancers (including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, gallbladder cancer, ampullary carcinoma) * p2 only: patients who have shown disease progress or recurrence of disease after receiving first-line or second-line systemic chemotherapy, including treatment with gemcitabine in combination with a platinum agent * patients aged 19 years or older * at least one lesion measurable defined by response evaluation criteria in solid tumors (recist) version 1.1. * life expectancy ≥ 12 weeks * ecog performance status 0 or 1 * women of childbearing potential must have a negative pregnancy test outcome * patients must provide written informed consent to voluntary participation in this study key exclusion criteria: * history of hypersensitivity reactions to any of the components of the investigational product or other drugs of the same class (humanized/human monoclonal antibody) and irinotecan or paclitaxel * less than 4 weeks have elapsed since a surgery * history of cardiac illness: new york heart association (nyha) class ≥ ii congestive heart failure (chf), uncontrolled hypertension, hypertension crisis, pulmonary hypertension, myocardial infarction, uncontrolled arrhythmia, unstable angina * persistent, clinically significant nci-ctcae v5.0 grade ≥ 2 toxicities from the previous anticancer therapy * severe infections or major and unhealed injury (active ulcer, untreated fracture) * symptomatic or uncontrolled central nervous system (cns) metastasis * pregnant or lactating women or patients planning to become pregnant during the study * participation in another clinical trial within 30 days prior to initiation of study treatment and received an investigational drug treatment * administration of antiplatelets or anticoagulants within 2 weeks prior to screening * requiring continuous treatment with systemic nsaids or systemic corticosteroids * hiv or other severe diseases that warrant the exclusion from this study

Keywords: vegf dll4 solid tumors bispecific antibody anti-angiogenic
association of intraoperative renal regional oxygen saturation and acute kidney injury

Conditions: Liver Transplant; Complications; Renal Injury

Summary: this study is a prospective observational study of a single cohort of the patients who will undergo a scheduled living donor liver transplantation. the investigators attempt to evaluate the association of intraoperative renal regional oxygen saturation and acute kidney injury in patients undergoing living donor liver transplantation. near-infrared spectroscopy sensor will be attached to the skin near bilateral kidney areas in all patients and renal regional oxygen saturation will be monitored during the operation. renal regional oxygen saturation (rso2) of the patients who developed acute kidney injury postoperatively will be compared with rso2 of the patients who did not.

acute kidney injury is a frequent complication after liver transplantation, which is related to poor prognosis and longer hospital stay. there is no sensitive or specific marker for predicting postoperative acute kidney injury, although studies of the biomarkers have shown promising results. near-infrared spectroscopy is a non-invasive and real-time monitoring device for regional oxygen saturation measurement. previous studies revealed that it could be applied to the skin near the kidney and be used to monitor renal regional oxygen saturation. therefore, in this study, the investigators will apply near-infrared spectroscopy around kidney area to measure real-time renal regional oxygen saturation during liver transplantation surgery and investigate the association between the intraoperative renal regional oxygen saturation and the development of post-transplant acute kidney injury.

Eligibility criteria:
inclusion criteria: * adult patients scheduled to undergo elective living donor liver transplantation * patients who provided written informed consent exclusion criteria: * missing preoperative serum creatinine value * underlying kidney disease, such as hepatorenal syndrome, chronic kidney disease * history of unilateral or bilateral nephrectomy * patients who died within 48 hours immediately after surgery * any skin problem at the attachment site of regional oxygen saturation probe

Keywords: near-infrared spectroscopy renal regional oxygen saturation living donor liver transplantation acute kidney injury
mini-invasive spine surgery for neuromuscolar scoliosis

Conditions: Neuromuscular Scoliosis; Spine Deformity; Surgery; Vertebral Fusion

Summary: neuromuscular scoliosis (snm) are deformities related to the impairment of normal function of the central nervous system (cns) and/or peripheral nervous system (pns) resulting in alterations to the of the functional unit represented by the integrated motor sequence (sim). at the level of the spine, dysfunction of the sim results in altered dynamic support of the spine. this results in a control of the trunk that is not harmonious due to the lack of effective mechanisms of muscle compensation. in particular, a greater degree of pelvic tilt with respect to the ground plane, with an increase in the degree of the so-called pelvic obliquity (op), a fundamental parameter in walking and maintaining the seated posture. spinal deformity causes severe alterations of the rib cage resulting in respiratory failure that often requires ventilatory supports and is associated with frequent airway infections, including pneumonias, often fatal. snms also express other comorbidities: cardiac (heart failure), neurological (epilepsy), nutritional that necessitate careful management multidisciplinary and especially anesthesiological evaluation for the peri-operative management. the surgical treatment of snm constitutes a topic that is still debated due to both the bio-mechanical peculiarities of snm and the clinical features, particularly comorbidities, that characterize this patient population. compared with idiopathic scoliosis surgery, in snm there is a higher rate of complications. to date, most of the complications are respiratory in nature (23%), followed by complications mechanical of the implanted surgical instrumentation (13%), and surgical site infections (11%). furthermore, there is evidence that snm surgery correlates with increased blood loss intraoperative. to date, it is recognized in the literature that the safest and most effective surgical treatment for snms is arthrodesis posterior instrumented with pedicle screws extended to the pelvis. in the years, mini-invasive surgical techniques have become increasingly prominent. invasive with the goal of reducing operative time, blood loss and complications themselves.


Eligibility criteria:
inclusion criteria: * diagnosis of snm * age 9 to 25 years * male and female gender * preoperative cobb \> 45° cobb * preoperative pelvic obliquity \> 10° * extent of scoliotic curve (expressed in cobb degrees) on supine whole spine x-ray ≤ 25% compared with magnitude of curve assessed on into spinal x-rays from supine sitting. * loss of walking ability * absence of emergency criteria for spinal surgery exclusion criteria: * scoliosis with etiology other than snm * pre-operative cobb \< 45° cobb * preoperative pelvic obliquity \< 10° * high anesthesiologic risk for severe respiratory deficit * criteria for surgical urgency * preserved ambulatory capacity * patients who did not perform follow-up at the rizzoli orthopaedic institute; * patients whose parents/guardians have denied consent for access to their own medical records. * language barrier
components of social functioning in survivors of pediatric brain tumors

Conditions: Brain Tumor, Pediatric; Medulloblastoma, Pediatric

Summary: children with brain tumors are at risk for a number of psychological late effects, including neurocognitive and social deficits. this observational study focuses on assessment of social functioning, including social-cognitive and neurocognitive abilities, in survivors of pediatric brain tumors. this study will also assess the influence of medical factors, including diagnosis and age at diagnosis, on social functioning. primary objective: examine the impact of social-cognitive and neurocognitive abilities on social functioning in survivors of pediatric brain tumors. secondary objective: assess the influence of medical factors such as diagnosis and age at diagnosis on the social functioning of survivors of pediatric brain tumors.

assessment of social and neurocognitive functioning in survivors of pediatric brain tumors who are least two years post-therapy and between 8 and 12 years of age will be included. participants will be recruited from two tumor types: 1) medulloblastoma, and 2) other brain tumors that were not treated with craniospinal irradiation. upon enrollment, participants will complete standard psychological questionnaires used to evaluate both performance-based and self-report measures of social and neurocognitive functioning. parents will complete questionnaires. families will be asked for permission to contact teachers to complete additional questionnaires. children will identify their best friend as part of their questionnaires and will be asked permission to contact this friend to complete two questionnaires. finally, children will be asked to complete an online daily diary of social interactions for seven days.

Eligibility criteria:
inclusion criteria: * diagnosis of medulloblastoma or other brain tumor * current age between 8 and 12 years, inclusive * at least 2 years post-completion of therapy * enrolled in school full-time * english speaking * cognitive and language capacity to complete measures * teacher inclusion: consent received from survivor and parent to contact. * best friends inclusion: (1) consent received from survivor and parent to contact, (2) english-speaking, (3) cognitive capacity to complete questionnaires as judged by the parent during the consent process. exclusion criteria: * diagnosis of a genetic disorder/pre-existing neurodevelopmental condition associated with neurocognitive or social impairment (e.g., autism, neurofibromatosis type 1 (nf1), down syndrome * homeschooled or full-time special education * iq less than 70 as documented in the medical record * inability or unwillingness of research participant or legal guardian/representative to give written informed consent. * other tumor cohort exclusion: (1) diagnosis of craniopharyngioma, (2) treatment history includes craniospinal irradiation (csi).

Keywords: survivorship social functioning social outcomes