Kornimate/medical-research-clean huggingface dataset:
anti-relapse efficacy and tolerance assessment of a cosmetic cream for very dry, irritated to atopic sensitive skin.

Conditions: Atopic Dermatitis; Eczema, Atopic

Summary: multicentric, double blind, randomized, comparative study with two parallel group: study group vs placebo group. 5 visits: inclusion visit \[day (d) 0\] and 4 follow-up visits (d30, d60, d90, and d120).

this is a prospective, double blind, multicentric and comparative study including 5 visits (on d0 which corresponds to inclusion visit, d30, d60, d90, and d120). it will take place from june 2024 to june 2025 in argentina (cirec latam, buenos aires) and india (cidp, new dheli). this study will include 100 patients (50 in india and 50 in argentina) who will be followed up for 120 days (± 3 days).

Eligibility criteria:
inclusion criteria: * general criteria: healthy subject (except ad and other atopic diseases - allergic rhinitis, conjunctivitis, and asthma). the subject can keep its usual treatment (antihistamines, inhaled corticosteroids, and antileukotriene treatment) during the study if applicable. written informed consent from the subject's parent(s)/legal representative(s) and children over 8 years old (specific argentina) and over 12 years old (specific singapore). subject accepting to continue the normal conditions of hygiene and sunscreen (if applicable). subject, parents/legal representative(s) willing to adhere to the study protocol and procedures. specific criteria: sex: male or female. age: from 6 months to 15 years. subject having on average one flare-up per month during the four months preceding the study, including the one observed on the inclusion visit d0. subject having easi value from 7.1 - 21 on d0 (moderate ad). subject having one atopic eruption on the inclusion visit which the dermatologist will prescribe topical corticosteroids or calcineurin's inhibitors (pimecrolimus and/or tacrolimus). exclusion criteria: * subject presenting cutaneous pathology in the studied zone other than ad (according to the investigator's appreciation, i.e., acne, psoriasis). subject using systemic treatment, including oral steroids and oral immunosuppressants e.g., ciclosporin during the previous weeks liable to interfere with the assessment of the cutaneous tolerance of the study product or placebo (according to the investigator's appreciation). subject using skin-moisturizing products from inclusion (d0) other than the study product or placebo. subject who had systemic therapy with immune-suppressive drugs and antibiotics within the last 14 days before the beginning of the study subject having serious illness that might require regular systemic medication (e.g., insulin-dependent diabetes, cancer) or conditions that exclude a participation or might influence the study evaluation. subject with documented allergies to the study product or placebo ingredients. subject enrolled in another clinical study during the study period. parent(s)/legal representative(s) considered by the investigator to be likely not compliant to the protocol.
accuracy of spybite forceps when compared to conventional sampling methods

Conditions: Accuracy of Tissue Diagnosis; Bile Duct Stricture; Pancreatic Duct Stricture

Summary: the investigators are evaluating the use of a spybite biopsy forceps for tissue diagnosis when compared to standard biopsy techniques.

the participants will undergo an endoscopic retrograde cholangiopancreatography (ercp) with cholangiopancreatoscopy and evaluation of a bile duct or pancreatic duct stricture with three different types of techniques for biopsy: spybite biopsy forceps, cytology brush and rj3biopsy forceps.

Eligibility criteria:
inclusion criteria: 1. subjects is 18 years or older 2. scheduled to undergo endoscopic retrograde cholangiopancreatography (ercp) wiht cholangioscopy and/or pancreatoscopy at the university of florida gainesville florida as medically indicated. 3. lesion of the pancreatobiliary system that requires tissue sampling as medically indicated 4. subject myst be able to give informed consent exclusion criteria: 1. any contraindication to endoscopic retrograde cholangiopancreatography (ercp) 2. the subject is unable to give informed consent
cavatak in patients with stage iiic or iv malignant melanoma to extend dosing to 48 weeks (vla-008 calm ext)

Conditions: Melanoma

Summary: this is an extended use study for patients who have received 10 doses of cavatak™ in the vla 007 trial. there may be patients who have benefitted from the study drug and who might benefit from further treatment. in order to accommodate those patients further treatment to complete 48 weeks of cva21 intratumoral injections will be made available.


Eligibility criteria:
inclusion criteria: * 1. patients must have reached week 24 of the core protocol in immune-related complete response (ircr), immune-related partial response (irpr), immune-related stable disease (irsd), or immune-related progressive disease (irpd) (unconfirmed) with evidence of tumor inflammatory reaction. * 2. if patient is in irpd (unconfirmed) status, they must not have had a decrease in their karnofsky performances scale (kps) score \> 10 points and to be judged to not have "rapid clinical deterioration" by the investigator since the subject's last tumor measurement leading to irpd assessment. * 3. patients must start treatment in the extension protocol within 8 weeks of their last injection administered in the core protocol. * 4. patient is able and willing to provide written informed consent to participate in the study. * 5. fertile males and females must agree to the use of an adequate form of contraception, e.g., condoms for males. exclusion criteria: * 1. tumors to be injected lying in mucosal regions or close to an airway, major blood vessel or spinal cord that, in the opinion of the investigators, could cause occlusion or compression in the case of tumor swelling or erosion into a major vessel in the case of necrosis. * 2. if lesions are too small to be visualized or palpable for accurate injection. * 3. currently in status of irpd (confirmed) or irpd (unconfirmed) without evidence of tumor inflammatory response, or with rapid clinical deterioration, or with a decrease of 10 points or more on their kps score since their last assessment before irpd (unconfirmed) assessment.

Keywords: melanoma calm
the application of personalized titanium plate in the bone tumors around the knee

Conditions: Bone Tumors

Summary: microwave ablation of bone tumors is time-consuming and usually results in postoperative fractures. hence the investigators designed and fabricated a titanium plate customized to the patient's bone structures for fixation after the removal of tumorous tissue, to improve the clinical outcomes of microwave ablation.

3d models of tumor-bearing bone segments were constructed by using computed tomography (ct) and magnetic resonance imaging (mri). the 3d models were used to design the model of personalized titanium plates. the model of the plates was transferred into a numerical control machine for manufacturing the personalized titanium plates by 3d printing technology. the plates were then surgically implanted for reconstruction assistance following microwave-induced hyperthermia to remove the bone tumor. implementation parameters and knee function were then evaluated.

Eligibility criteria:
inclusion criteria: 1. clinical diagnosis of primary malignant bone tumors in the distal femur or proximal tibia according to the preoperative biopsy. 2. malignant soft tissue tumor invading distal femur or proximal tibia. 3. the patients have the opportunity of limb salvage and treatment of microwave-induced hyperthermia in situ and reconstruction with internal fixation. exclusion criteria: 1. distant metastasis. 2. benign tumor. 3. metastatic tumor around the knee. 4. no indication of limb salvage. 5. malignant soft tissue tumor without bone invasion. 6. recrudescent tumors.

Keywords: knee titanium plate
laryngeal mask ambu aura once vs. supreme in children

Conditions: Apnea

Summary: the purpose of this study is determine safety and efficiency of mechanical ventilation in children with two different types of single use laryngeal masks (ambu auraonce vs. lma supreme). the main interest is leakage pressure of oropharynx and stomach. the null hypothesis is that leakage pressures of ambu auraonce and lma supreme are equivalent. the alternative hypothesis is that there is a difference in leakage pressure.

before starting surgery patients will be anesthetised and airway managed either with lma ambu auraonce or supreme. ventilation parameters, stomach inflation, and hemodynamic parameters will be measured.

Eligibility criteria:
inclusion criteria: * children aged 1-10 years * asa i - iii * elective procedure in general anaesthesia * parental informed consent exclusion criteria: * non fasting patient * body mass index \> 35 kg/m2 * cervical spine pathologies or peripheral neurologic deficiences * malformations of upper airway or head * anamnestic hiatus hernia or esophageal reflux * status post operation of stomach or esophagus * recurrent respiratory infection or obstructive airway disease * non elective procedure

Keywords: laryngeal mask, leakage pressure, ventilation
n-acetylcysteine protection against radiation induced cellular damage

Conditions: Cardiac Arrhythmia

Summary: catheter ablation procedures (caps) are first line treatment for a great variety of cardiac arrhythmias. caps require x-ray imaging; consequently, caps cause ionizing radiation (ir) exposure for patients. exposure to ir, even at low-doses, increases individual risk of developing cancer. ir cause dna damage directly and, mostly, indirectly by formation of cellular free radicals. furthermore different response to ir results from inherited variants in genes involved in dna damage repair. n-acetylcysteine (nac) is an aminoacid that can directly neutralize free radicals and increase antioxidant systems. our preliminary data suggest that ir exposure in patients undergoing cap deranges the oxidative stress status and the pre-procedure intravenous administration of nac could decrease such abnormality.

carapace is a prospective, randomized, single-blinded, parallel-arm monocenter study. eligible patients undergoing cap at the arrhythmology unit of centro cardiologico monzino will be enrolled. the hypothesis driving our study, based on published literature and our preliminary data, is that administration of antioxidant agents, before cardiac procedures involving ir exposure, might prevent ir harmful effects on human tissues in terms of reduction of systemic oxidative stress status and, in parallel, of oxidative dna damage. the antioxidant agent tested in our study is nac. nac is a well-tolerated and safe medication and it has antioxidant properties is based on three main mechanisms: 1) direct antioxidant effect, 2) glutathione (gsh) precursor action, and 3) its activity in breaking thiolated proteins. another hypothesis to be tested is whether genes involved in dna damage repair could explain the great variability in patient radiosensitivity to ir exposure and whether these genes could affect nac protective/healing effects.

Eligibility criteria:
inclusion criteria: * patient's age \>18 years. * negative hcg pregnancy test (if appropriate). * indication to perform cap guided by fluoroscopy (ir imaging). * ability and willingness to give informed consent and to comply with protocol. exclusion criteria: * any contraindication to cap (such as, pregnancy and breastfeeding). * hypersensitivity to the active substance or to any of the excipients. * enrollment in another study that may interfere with carapace study. * administration of an experimental drug within 30 days or 5 half-lives of the investigational drug. * chronic kidney disease (serum creatinine \>1.5 mg/dl). * acute/chronic inflammatory disease. * antioxidant drugs intake over the previous 2 weeks. * history of radiotherapy or chemotherapy in the last year. * any documented condition that, in pi's motivated judgement, makes the patient a poor candidate for the study. * computed tomography and/or coronary angiography within 5 days prior to baseline analysis.

Keywords: electrophysiology arrhythmias arrhythmia ablation ionizing radiation risk oxidative stress dna damage biomarkers
osimertinib as 1st line therapy for patients with advanced egfr positive non-small cell lung cancer

Conditions: Lung Cancer Non-small Cell Stage IV

Summary: the present study will evaluate the use of osimertinib as 1st line therapy for patients with advanced egfr positive non-small cell lung cancer who are treated at hellenic cooperative oncology group (hecog)-affiliated departments of oncology.

this will be an observational, multicentric, retrospective/ prospective analysis of patients with advanced egfr positive non-small cell lung cancer that receive osimertinib as 1st line therapy. the patient data will be collected at hellenic cooperative oncology group (hecog)-affiliated departments of oncology during scheduled patient clinical visits, from february 2020 for a total period of three years. the biological material obtained from the patients of this analysis will be possibly used in a future translational study as an exploratory analysis.

Eligibility criteria:
inclusion criteria: * men or women of 18 years or older that live in greece * histologically or cytologically confirmed, advanced egfr positive non-small cell lung cancer * untreated patients for advanced nsclc * patients who are expected to receive osimertinib regardless of their enrollment in the study * signed written informed consent exclusion criteria: * patients with cancer other than nsclc that require treatment * pretreated patients for nsclc * patients that receive or are expected to receive or have received an investigational drug/product/intervention

Keywords: non-small cell lung cancer egfr mutation osimertinib
influence of obesity on propofol pharmacokinetics during cardiopulmonary bypass

Conditions: Obesity

Summary: the primary objective of this study is to develop a descriptive and predictive pharmacokinetics model propofol disposition during cardiopulmonary bypass (cpb) in obese and lean patients.

anaesthesia maintenance upon initiation of cpb will be achieved by propofol (1%) bolus (1 mg/kg tbw) immediately followed by 2 mg/kg tbw/hr infusion that will be continued till weaning from cpb. during cpb an additional propofol bolus doses can be administered to prevent awareness according to the clinical judgment of the responsible anaesthesiologist. any additional doses given and their timings will be recorded. blood samples of 2 ml each will be collected from the arterial line of cpb machine until the end of cpb then from sub-clavin arterial catheter routinely inserted in such surgeries. sampling process will follow the following schedule; at baseline prior to dosing, followed by samples at 1, 3, 5,7 min after the propofol bolus dose, then every 20 minutes during propofol infusion, just before discontinuation of the propofol infusion and at 1, 3, 5, 7, 10, 20, 30, 60 minutes after the end of infusion. in addition, just before any rescue propofol dose administration, an unscheduled sample will be withdrawn

Eligibility criteria:
inclusion criteria: * bmi ≤ 25 kg/m2 or ≥ 30 kg/m2. * propofol based maintenance of anaesthesia during cpb. exclusion criteria: * pregnant women or lactating mothers. * renal (serum creatinine concentration\>1.5 or creatinine cl ≤ 30 ml/min) or hepatic disorders (total bilirubin \>1.5 or ≥ 2 fold increase in alanine transferase (alt) or aspartate transferase (ast). * systemic infections. * hypoalbuminemia (defined as albumin \<3.5 gm/dl). * known history of alcohol or drug abuse. * administration of aspirin on the day of surgery or warfarin within 7 days preceding surgery

Keywords: propofol cardiopulmonary bypass pharmacokinetics obesity
benefits of insulin supplementation for correction of hyperglycemia in patients with type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: the purpose of this study is to test whether using extra doses of aspart insulin to correct blood sugars before meals improves the care of patients with type 2 diabetes in the hospital who are already receiving the standard of care treatment with glargine and aspart insulin injections to control blood sugar levels. studies done in the past indicate that blood sugar levels are controlled on the standard treatment of insulin and that most patients do not need the small extra dose of insulin at bedtime. the investigators want to test if there is any benefit to giving patients extra doses of insulin during the day to correct the high blood sugars.

the management of patients with type 2 diabetes involves treatment with two different types of insulin injections to control blood sugar levels. the doses of the two types of insulins, glargine insulin and aspart insulin are adjusted daily through the hospital stay based on blood sugar levels. many times, in addition to glargine and aspart insulin at meals, additional small doses of aspart insulin are given to correct high blood sugar levels. it has not been determined if using these extra doses of aspart insulin to correct blood sugars before meals improves care of the patients. studies done in the past indicate that blood sugar levels are well controlled on the standard treatment of the two insulins and that most patients do not need the small extra dose of insulin at bedtime. this study will test if insulin supplementation improves glycemic control and prevents hypoglycemia in insulin treated patients with type 2 diabetes mellitus.

Eligibility criteria:
inclusion criteria: 1. subjects admitted to the hospital with acute or chronic medical illnesses or for elective and emergency surgical illness or trauma 2. known history of type 2 diabetes mellitus for \>3 months 3. treated with either diet alone, any combination of oral antidiabetic agents, non-insulin injectables or insulin therapy 4. blood glucose levels between \>140 mg and \<400 mg/dl without laboratory evidence of diabetic ketoacidosis exclusion criteria: 1. hyperglycemia without a history of diabetes 2. subjects with acute critical illness admitted to the icu or expected to require icu admission 3. subjects receiving continuous insulin infusion 4. clinically relevant hepatic disease 5. corticosteroid therapy 6. serum creatinine ≥ 3.5 mg/dl and/or glomerular filtration rate (gfr) \<30 7. subjects unable to sign consent 8. pregnancy

Keywords: hyperglycemia hypoglycemia
comparison of insulin detemir and insulin aspart in 2 separate injections twice daily to extemporaneous mixing injection regimen twice daily - the paediatric mixing trial

Conditions: Diabetes; Diabetes Mellitus, Type 1

Summary: this trial is conducted in europe. the aim of the trial is to compare two methods of injection in basal-bolus insulin regimen in children with type 1 diabetes with insulin detemir associated with insulin aspart given twice daily in either separate or mixed injections and to investigate if there is any clinical impact in choosing one regimen over another.


Eligibility criteria:
inclusion criteria: * parents' informed consent (ic) obtained before any trial-related activities * obtained child's assent (when possible) * type 1 diabetes * treatment with insulin detemir and insulin aspart either in extemporaneous mixed or separate injections * hba1c (glycosylated haemoglobin a1c) lesser than or equal to 8.6% exclusion criteria: * history of alcoholism, drug abuse, or psychiatric disease or personality disorders likely to invalidate voluntary consent or to prevent good compliance with the trial protocol * mental incapacity, unwillingness or language barrier precluding adequate understanding or co-operation * anticipated change or new use in concomitant medication known to interfere with glucose metabolism, such as systemic corticotherapy more than 5 mg/day (prednisone) * any other condition that the investigator (trial physician) feels would interfere with trial participation or evaluation of results
phase 2 evaluation of multi-modality algorithm for non-metastatic adenocarcinoma of pancreas or ampulla

Conditions: Ductal Adenocarcinoma of Pancreas; Adenocarcinoma of Ampulla

Summary: patients diagnosed with pancreatic cancer without clinically detectable metastatic disease will be treated with standardized systemic chemotherapy, followed by chemoradiation, and then surgical resection for those with resectable or borderline resectable disease. the primary endpoint is disease-free survival at 1 yr from initiation of treatment.

patients with ductal adenocarcinoma of the pancreas (or ampulla) that have received no prior therapy and have no clinically detectable metastatic disease will be enrolled. management will be driven by resectability status as defined by the american college of surgeons. all patients will be defined at entry as resectable, borderline resectable or locally advanced (unresectable). all patients will be treated initially with gemcitabine and nanoparticle albumin bound paclitaxel (nab-paclitaxel) every 14 days for 4 cycles. patients classified as resectable, who have ca19-9 below 180 and ca-125 below 30 will then proceed to resection. all other patients will get 5-fluorouracil as 46 hr infusion given with leucovorin and irinotecan (folfiri-3) every 14 days x 4 cycles. all patients without progression will then receive chemoradiation consisting of external beam radiotherapy (40 gy in 20 fractions given over 4 weeks). during radiation all patients will receive radiosensitizing radiotherapy as: 5-fluorouracil at 225 mg/m2 5 days per week, mitomycin-c at 3 mg.m2 on d1, 8, 15 \& 22; cisplatin at 10 mg/m2 on d2, 9, 16, 23 and unfractionated heparin at 6,000 units/m2 daily in divided doses from day 1 to day 28. after approximately 4 weeks to recover from chemoradiation, all patients with resectable or borderline resectable disease will undergo definitive surgery. adjuvant therapy with folfir-3 for an additional 6 cycles will be offered to all patients post-operatively. patients will then be actively followed every 3 to 6 months in keeping with national comprehensive cancer network (nccn) guidelines for 2 yrs, and then followed for recurrence, late toxicity and vital status every 6 months through 5 years.

Eligibility criteria:
inclusion criteria: * histologic proof of adenocarcinoma consistent with ductal carcinoma of pancreas or ampulla, with no evidence of metastatic disease by clinical exam or cross-sectional imaging. * fitness for chemotherapy in judgement of treating physician * bilirubin \< 4 (any means of biliary drainage acceptable) exclusion criteria: * medical or mental illness precluding provision of informed consent * pregnancy * active infection for which neutropenia would pose high risk of mortality