Kornimate/medical-research-clean huggingface dataset:
application of palliative treatment in children with brain stem glioma and recurrent high-grade tumors in the central nervous system with the nanomaterial npt-ca

Conditions: Brain Tumor, Pediatric, Brainstem Glioma; Brain Tumor, Pediatric, Recurrent

Summary: this protocol is a pilot, clinical interventional study to selected patients between five and fourteen years of both sexes, carriers of the diagnosis of glioma brain stem and high grade recurrent in the central nervous system tumors, in whom there has been no response to conventional-based surgery/radiation/chemotherapy treatment or whose location does not allow treatment with conventional measures, and that already have an indication for a neurosurgical palliative procedure. it will be a close pharmacovigilance on possible adverse effects related to the nanomaterial based on the profile of cisplatin (chemotherapeutic platinum derivative), since documented toxicity data are not counted for npt-ca. quality of life will be documented with pedsql cancer module© and tumor size by magnetic resonance brain images.


Eligibility criteria:
inclusion criteria: * histopathological diagnosis or mri of the brain stem or tumor of recurrent high-grade glioma. * indication of palliative surgical treatment by neurosurgery. * good general condition, enabling the realization of surgical treatment. * scale lansky \> 20) * conventional treatment (surgery, radiotherapy, and chemotherapy) failed or not applicable to the patient. exclusion criteria: * patients with emerging infectious diseases or fever in the last 72 hours prior to placement of the npt-ca. * patients whose parents/carers do not authorize expressly the realization of procedure with knowledge of its experimental nature, are not agreed or established their commitment to meet follow-up parameters established by this protocol. * patients with surgical complications prior to placement of the npt-ca. * patients in which the size and location of the lesion do not allow their surgical approach or an increase in volume by infiltration of the lesion with 3 ml of volume of npt-ca. * patient whose neurological condition do not allow the implementation of mri without anesthesia.
alternative sedation during bronchoscopy

Conditions: Sedation

Summary: this protocol hopes to determine whether the use of dexmedetomidine-ketamine can reduce the use of standard of care fentanyl-midazolam sedation during bronchoscopy. this may result in less respiratory depression while providing better compliance with the procedure.

all patients enrolled in the study will be undergoing bronchoscopy, which is typically performed with sedation. all procedural sedation carries some risk. several features of the study may lower the risk of sedation relative to that of conventional sedation. an anesthesiologist will be present throughout the procedure. continuous monitoring of respiration with rip will be employed. administration of sedation will be via a volumetric syringe pump. benefits specific to dexmedetomidine-ketamine include the lack of respiratory depression and greater hemodynamic stability.

Eligibility criteria:
inclusion criteria: * adults over the age of 18 scheduled for elective flexible bronchoscopy in the endoscopy suite or or of hup exclusion criteria: * history of inability to complete bronchoscopy attributable to inadequate sedation * requiring more than 2 lpm supplemental oxygen to maintain sao2 \> 90% * history of allergy to study medications * pregnancy * a history of psychosis * any condition deemed likely by the pulmonologist or anesthesiologist to pose a significant risk due to elevation of blood pressure, including cerebral/aortic aneurysm, and or ischemic cardiovascular disease * bradydysrhythmia deemed significant by the anesthesiologist or pulmonologist * a diagnosis of significant renal or hepatic impairment

Keywords: bronchoscopy
effect of cerebrolysin on the blood brain barrier in patients with diabetes and ischemic stroke

Conditions: Ischemic Stroke, Acute; Diabetes Mellitus, Type 2; Blood Brain Barrier

Summary: a prospective, single-center study would be carried out in the neurology department of the university hospital "dr. josé eleuterio gonzález" in order to analyze the effect of cerebrolysin on the blood-brain-barrier in patients with ischemic stroke with personal history of type-2 diabetes

a prospective, single-center study would be carried out in the neurology department of the university hospital "dr. josé eleuterio gonzález" in order to analyze the effect of cerebrolysin on the blood-brain-barrier (bbb) in patients with ischemic stroke (is) of the middle cerebral artery with personal history of type-2 diabetes (t2d). the main objective is to compare the effect of cerebrolysin on the bbb in the above mentioned patients with intravenous thrombolysis (ivt) and without ivt. the hypothesis of this study is that cerebrolysin can affect the bbb permeability after 10 days of the administration of this drug

Eligibility criteria:
inclusion criteria: 1. age 18 - 80 years. 2. clinical and imaging criteria for ischemic stroke of the middle cerebral artery. 3. acute non-lacunar cerebral infarction. 4. cerebral infarction with a score on the nih scale between 5 and 20 points. 5. patient with a previous diagnosis of type 2 diabetes mellitus, regardless of the form of diagnosis, time of evolution, previous or current treatment, adherence or not to treatment, presence or absence of microvascular and/or macrovascular complications. 6. mrs ≤ 1 before the qualifying stroke (functionally independent for all activities of daily living). 7. the patient and/or legal representative or direct family member has signed the informed consent form. exclusion criteria: 1. advanced disease or terminal with life expectancy \< 6 months. 2. - over 80 years old 3. lacunar infarction or small vessel disease. 4. pre-existing medical, neurological, or psychiatric disease that would confound neurological or functional evaluations (eg, alzheimer's disease, vascular dementia, parkinson's disease, demyelinating disease, encephalopathy of any cause, history of significant alcohol or drug abuse). 5. pregnancy or lactation. 6. acute or chronic renal failure with creatinine clearance \<30 ml/min. 7. allergy or any condition that represents a contraindication for the administration of cerebrolysin. 8. treatment with another investigational drug within the past 30 days that may interfere with the study drug.

Keywords: stroke diabetes mellitus type 2
long-term safety and efficacy of spark-sponsored gene therapies in males with hemophilia a

Conditions: Hemophilia A

Summary: this long-term follow-up study will continue to evaluate the long-term safety and efficacy of spk-8011 and spk-8016 in males with hemophilia a, who have received a single intravenous administration of spk-8011 or spk-8016 in any spark-sponsored spk-8011 or spk-8016 study.

this study will follow patients with hemophilia a, who have received a single intravenous administration of spk-8011 or spk-8016 in any prior spark-sponsored spk-8011 or spk-8016 study. participants will be followed for up to a total of 10 years post infusion (including the time on the dosing study).

Eligibility criteria:
inclusion criteria participants are eligible to be included in the study only if all of the following criteria apply: 1. have received a single intravenous administration of spk-8011 or spk-8016 in either study spk-8011-101 or spk-8016-101, respectively. 2. understand the purpose and risks of the study and provide signed and dated informed consent before undergoing any study-specific procedures. exclusion criteria participants are excluded from the study if any of the following criteria apply: 1.unable or unwilling to comply with the schedule of visits and study assessments as described in this study protocol.
management of drug hypersensitivity in children

Conditions: Drug Hypersensitivity

Summary: the aim of this study is (1) to assess the incidence of suspected drug allergies in a pediatric hospital and the proportion in which these reactions are confirmed to be allergic; (2) to evaluate the diagnostic values of the different allergy tests available; (3) to investigate the pathophysiology of drug allergies, particularly by investigating the role of viruses, and by performing hla typing and a gene expression profile both in the acute phase of the reaction and 2 months later.


Eligibility criteria:
inclusion criteria: * participation will be proposed to any children (0 to 16 years) receiving one or several drug(s) and developing one of the following clinical manifestations: urticaria, maculopapular rash, bullous eruption, flush, anaphylaxis, serum sickness-like disease, sjs, ten, dress or fever linked to drug intake. exclusion criteria: * patients will be excluded if the symptoms occur more than 72 hours after any treatment was stopped or if the symptoms are clearly linked to another cause (measles, rubeola, roseola, varicella, fifth disease, gianotti-crosti syndrome, scarlet fever, gibert's pityriasis or food allergy).
cellvizio to evaluate margins in crohn's ileal disease

Conditions: Crohn Disease; Resection Margins; Recurrence

Summary: crohn disease is an inflammatory bowel disease. a surgical procedure is required in about 80% of cases. surgery doesn't cure from crohn's disease but the type of surgery remains important as there are several intraoperative risk factors for recurrence. among these factors the microscopic inflammation at the resection margins. this is a crucial point, if the resection is too large there is a risk of short bowel syndrome, if the resection is too short (microscopic inflammation at resection site), there is a higher risk of postoperative recurrence (75% vs 46% at 18 months). surgeons have to do a limited resection (2cm from macroscopic crohn disease). however this macroscopic non inflammatory resection margin can be microscopically inflammatory (up to 80%). thus it is useful to evaluate if there is a microscopic inflammation at the resection margin. moreover there is an increase interest for the role of the mesentery for recurrence but its role remains unclear. it is of interest to clarify the border between the inflammatory and non-inflammatory mesentery. cellvizio is a confocal laser endomicroscopy providing the possibility of obtaining in vivo high-magnification images of the gut epithelium. this allows real-time examination of the gastrointestinal mucosa at the cellular and subcellular level. cellvizio has never been used during surgery for crohn disease. the aim of this study is to evaluate the intraoperative use of cellvizio (using the celioflex microsonde) with an intravenous injection of fluorescein to determine the best ileal resection margins in crohn disease.


Eligibility criteria:
inclusion criteria: * patients who need a ileocaecal resection for a crohn disease whatever is the phenotype of the crohn's disease exclusion criteria: * patients\<18 years old, * pregnancy or breastfeeding, * patients who have an ileocolic resection for a surgical recurrence of the crohn's disease. * patients operated in emergency for a peritonitis, * patients who have a contra-indication for fluorescein injection or severe allergia to any drug

Keywords: crohn disease resection margins recurrence
symptoms comparison: suture-stent vs conventional double-j stents after ureterorenoscopy. a prospective randomized trial

Conditions: Symptoms and Signs; Pain; Ureteral Calculi

Summary: double j ureteral stents (dj) are widely used in urological practice and commonly inserted after most of ureteroscopies. stent-related symptoms (srs) represent a major issue. many research lines have been explored with the aim of decreasing srs: vogt et al. projected a self-made pigtail suture stent (pss) replacing the distal pigtail with a 0.3 fr suture reaching the bladder, showing decreased srs and good tolerance. to date, these promising results hasn't been confirmed by a prospective randomized controlled trial (rct) involving a marketed pss. thus, we designed a prospective single-blind rct to compare srs caused by marketed pss and conventional dj after uncomplicated urs for stone treatment.


Eligibility criteria:
inclusion criteria: * ureteral or renal stones \< 2 cm needing treatment through semirigid or flexible urs and laser lithotripsy * stone-free procedure and absence of intraprocedural complications * who performance status 0-2 exclusion criteria: * significant residual fragments at the end of the procedure * intraprocedural complications (e.g. ureteral damage or stricture) * indwelling double j stent * acute kidney failure * urinary tract infection * urinary tract abnormalities * pathologies or medications potentially influencing voiding pattern and pain perception

Keywords: symptoms and signs pain ureteral calculi ureteroscopy ureteral stents
chlorhexidine disk for prevention of exit-site infection in peritoneal dialysis patients

Conditions: Peritoneal Dialysis Catheter Exit Site Infection

Summary: the purpose of the study is to evaluate the efficacy and safety of chlorhexidine-impregnated disk in preventing catheter exit-site infection in peritoneal dialysis patients

the primary aim of the study is to examine the exit-site infection rate in patients using chlorhexidine-impregnated dressing. the participant will be followed up at 2, 6, 12, 24, 36 and 52 weeks of study and during each visit the catheter exit-site will be examined by one of the investigators for any sign of infection or allergic reaction, and questionnaires about satisfaction with use of study material (biopatch) will be asked by a study team member at the 12 week visit of the study. each participant will be followed up for one year.

Eligibility criteria:
inclusion criteria: * all adult incident peritoneal dialysis patients between 21 to 90 years old, who are followed up in singapore general hospital exclusion criteria: 1. patients who have known history of allergy to chlorhexidine 2. patients who had previous history of peritoneal dialysis catheter exit-site infection 3. patients with mentally challenging conditions who are unable to give the valid consent for the study 4. patients who have been involved in another study for exit site infection

Keywords: peritoneal dialysis chlorhexidine exit site infection tunnel tract infection
sb-715992 in combination with docetaxel in patients with solid tumors

Conditions: Solid Tumor Cancer

Summary: the purpose of this study is to determine the dose regimen of sb-715992 in combination with docetaxel in patients with solid tumors. sb-715992 and docetaxel were dosed by 1-hour intravenous infusion every 3 weeks (on the same day). a patient may continue to receive treatment as long as they are benefiting from the treatment. blood samples will be taken at specific times to measure the amount of both drugs in your body at specific times after the drug is given. blood samples will also be taken for lab tests such as complete blood counts and clinical chemistries. physical exams will be performed before each treatment with sb-715992. during the treatment phase, the patients will undergo regular assessments for safety and clinical response.


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed diagnosis of an advanced solid tumor malignancy that is not responsive to standard therapies or for which there is no standard therapy. * ecog (eastern cooperative oncology group) performance status of 0-2. exclusion criteria: * females who are pregnant or nursing. * pre-existing hemolytic anemia. * pre-existing peripheral neuropathy greater than or equal grade 2. greater than or equal to 4 prior chemotherapy regimens including neoadjuvant/adjuvant chemotherapy, except breast cancer subjects who may have received more than 4 prior chemotherapy regimens. * absolute neutrophil count less than 1,500/mm3. * platelets less than 100,000/mm3. * hemoglobin less than 9 g/dl. * total bilirubin greater than1.5 mg/dl. * ast/alt greater than 2.5 x upper limit of normal. * creatinine clearance less than or equal to 60 ml/min (calculated by the cockcroft gault formula). * known contraindications to the use of docetaxel or to other drugs formulated with polysorbate 80.

Keywords: safety tolerability dose limiting toxicity solid tumors docetaxel
enteral nutrition and amino acid absorption

Conditions: Malabsorption

Summary: the purpose of this study is to evaluate amino acid absorption with two different type of proteins.


Eligibility criteria:
inclusion criteria: * patient with gastrointestinal disorder : citrulline plasma concentration \< 20 µmol/l and/or xylose plasma concentration \< 1,7 mmol/l * patient under enteral nutrition at home * patient already receiving 1 l by day exclusion criteria: * obese patient bmi \> 30 * diabetes * renal or liver failure * glucocorticoids treatment
the prevalence and clinical characteristics of children with local allergic rhinitis

Conditions: Other Allergic Rhinitis

Summary: * to determine prevalence of local allergic rhinitis (lar) * to evaluate clinical characteristic and severity of local allergic rhinitis * to measure changing of tryptase and specific ige for dermatophagoides pteronyssinus (dp) after nasal allergen provocation test (napt)

children 8-18 years with nar were recruited. a napt with der p 1 solutions (napt-dp) at 200 au/ml, 600 au/ml and 2000 au/ml at 15-minute interval was performed, respectively. the immediate responses to napt-dp were assessed using symptoms score, peak nasal inspiratory flow (pnif) and acoustic rhinometry (arm). the nasal tryptase and sige-dp were measured at baseline, 15 min and 1 h after positive napt-dp. allergic rhinitis (ar) patients were used as positive control.

Eligibility criteria:
inclusion criteria: * children 8-15 years who were diagnosed with nonallergic rhinitis (nar) at least 1 year * no respiratory infections in the previous 4 weeks * no following treatment of * systemic corticosteroid 4 weeks * intranasal corticosteroid 2 weeks * oral antihistamine 1 week * leukotriene antagonist 1 week exclusion criteria: * patients with underlying disease: * chronic rhinosinusitis and nasal polyp * immunological disease * chronic renal disease * hepatobiliary disease * cardiovascular disease * cancer * parental withdraw consent * patient with uncontrolled asthma, peak expiratory flow rate (pefr) \< 80% of predicted

Keywords: 1 prevalence 2 children 3 local allergic rhinitis
clinical one-stage controlled study of resistant arterial hypertension for the designing of a personalized approach to therapy

Conditions: Resistant Arterial Hypertension

Summary: this study was planned to assess the concentration of antihypertensive drugs in the blood plasma in patients with controlled and uncontrolled arterial hypertension. methods: it is planned to include patients with arterial hypertension taking 3 antihypertensive drugs (indapanide, lisinopril or valsartan, amlodipine). based on the results of 24-hour blood pressure monitoring, the patients will be randomized into two groups: the first group - the patients with controlled ah; the second group - the patients with uncontrolled ah. venous blood was taken in both groups of the patients in the morning before and 2 hours after taking drugs to assess the concentration of lisinopril, amlodipine, valsartan and indapamide. concentation of assesed antihypertensive drugs will be compared in both groups.


Eligibility criteria:
inclusion criteria: * signed informed consent form; * an established diagnosis of ah based on the clinical guidelines "arterial hyperten-sion in adults", approved by the scientific and practical council of the ministry of health of the russian federation, 2020; * mandatory patient compliance with recommendations for lifestyle modification in accordance with the clinical guidelines "arterial hypertension in adults", approved by the scientific and practical council of the ministry of health of the russian federation, 2020 . * regular administration of any two antihypertensive drugs (lisinopril, amlodipine, valsartan) in combination with indapamide for a month, possibly in fixed combinations, in stable dosages; * fertile female patients must use proper methods of contraception throughout the study period. exclusion criteria: * patient's connection with the organization or conducting of the study; * pregnancy.

Keywords: antihypertensive drugs concentration hplc ms/ms
auricular acupressure therapy for patients with ic/bps

Conditions: Interstitial Cystitis; Bladder Pain Syndrome; Urologic Diseases; Chronic Pain

Summary: the purpose of this study is to determine the feasibility of administering auricular acupressure for patients with interstitial cystitis/bladder pain syndrome (ic/bps), and evaluating the efficacy of auricular acupressure to reduce pain scores and decrease pain medication usage over time.

eligible participants will be asked to complete baseline questionnaires. after completion, a study interventionist will place 10 adhesive acupressure pads/seeds on the participant's ears (5 on each ear). each seed will be placed on a specific site on the ear believed to help with pain and overall well-being. over the course of 5 days, participants will be asked to apply a small amount of manual pressure with their fingers to each of the ear pads and answer daily study questionnaires. this feasibility trial is being conducted in collaboration with the battlefield auricular acupressure (baapress) training and intervention fidelity study (irb00084011).

Eligibility criteria:
inclusion criteria: * age \>= 18 years * history of documented interstitial cystitis/bladder pain syndrome (ic/bps) * able to read and understand informed consent form in english exclusion criteria: * patients with a history of skin disease (e.g. psoriasis) involving the ear, adhesive allergy, recent scar tissue on ear, or current abrasions or cuts on the ear * cognitive impairment (e.g. delirium, dementia) * physical impairment preventing them from applying daily pressure/stimulation to ear seeds * patients with cardiac pacemakers (contraindication to pointer pal) * use of some types of hearing aids (which could potentially obstruct placements of ear seeds) * any acute illness or psychiatric conditions that would impact adherence to the study requirements

Keywords: interstitial cystitis bladder pain syndrome pelvic pain urologic pain urologic disease
neuromuscular electrical therapy in venous ulcers

Conditions: Chronic Venous Insufficiency

Summary: the use of neuromuscular electrical stimulation in the treatment of venous ulcers with difficulty of repair could be an alternative therapeutic favoring devitalized tissues and hence the pain. the aim of this study is to evaluate the effect of neuromuscular electrical stimulation on pain and area of venous ulcers in patients with venous insufficiency.

the aim was to evaluate the effect of neuromuscular electrical stimulation on pain and area of venous ulcers in patients with venous insufficiency. in a simple-blind controlled clinical study, 20 subjects with venous ulcers with age over 50 years will be divided in two groups:neuromuscular electrical stimulation(n=10) and control group (n=10). pain (by visual analogue scale) and the ulcer area (by planimetry on graph paper and the software imagej ®) were measured.

Eligibility criteria:
inclusion criteria: * subjects of both genders * aged over 50 years * sedentary and with clinical diagnosis of chronic venous insufficiency with ulcer in lower limbs will be included exclusion criteria: * subjects with pacemakers * diabetes * uncontrolled hypertension * osteomyelitis and pain of unknown origin * unable to walk or make use of drugs that acted directly on the healing process will be excluded

Keywords: varicose ulcer wound healing electrical stimulation