Kornimate/medical-research-clean huggingface dataset:
role of samital® in the relief of chemo-radiation (ct-rt) induced oral mucositis in head and neck cancer patients

Conditions: Head-and-neck Squamous Cell Carcinoma; Oral Mucositis

Summary: the purpose of this study is to: * evaluate the activity of samital in reducing the incidence of severe mucositis in head-and-neck cancer patients undergoing chemo-radiotherapy. * assess tolerability of samital and the impact on patients reported outcomes.


Eligibility criteria:
inclusion criteria: * histologically proven squamous cell carcinomas of the head-and-neck * eligible primary tumor sites: oral cavity, oropharynx, larynx, hypopharynx * stage iii or iv disease without evidence of distant metastases * patients candidate to definitive concurrent chemo-radiotherapy or induction chemotherapy followed by chemo-radiotherapy * age ≥ 18 years * karnofsky performance status ≥70 * life expectancy ≥6 months * able to swallow and retain oral medication * good state of dentition * patients must be available for treatment and follow-up * confirmation of adequate contraception use by the patient and/or partner * signed informed consent exclusion criteria: * previous radiotherapy of the oral cavity, and/or oropharynx, larynx, hypopharynx * serious co-morbidities: uncontrolled heart disease, heart failure within 6 months prior to study participation, history of serious neurological and/or psychiatric abnormalities. * chronic administration of steroids or immunosuppressants * pregnancy.

Keywords: head and neck squamous cell carcinoma oral mucositis chemo-radiotherapy
study comparing budesonide hydrofluoroalkane (hfa) vs chlorofluorocarbon (cfc) pressurized metered dose inhalers (pmdi) in patients with mild to moderate asthma

Conditions: Asthma

Summary: this study is being carried out to see if budesonide with hfa is effective, safe and well tolerated compared with budesonide cfc. budesonide hfa has been already given in other research studies, in both healthy volunteers and subjects with asthma.


Eligibility criteria:
inclusion criteria: * patients suffering from stable, persistent, mild to moderate asthma as defined by global initiative for asthma (gina) guidelines and for whom fev1 \> 60 % * ics taking ≤ 1000 μg bdp per day, or equivalent * methacholine pc20 \< 4 mg/ml exclusion criteria: * known or suspected hypersensitivity to budesonide or any other constituents of the budesonide hfa pmdi or budesonide cfc pmdi. * currently a smoker or who has ceased smoking within 6 months of visit 1. * exacerbations of asthma requiring oral steroids, hospitalisation or change in asthma therapy in the previous three months. * diagnosis of chronic obstructive pulmonary disease (copd) or bronchiectasis

Keywords: asthma hyperreactivity
pericardial effusion from acute myocardial infarction: contributing factors and prognosis at one year (epericardim)

Conditions: Acute Myocardial Infarction; Pericardial Effusion

Summary: this study aims to clarify, in patients with more or less abundant pericardial effusion in the acute phase of a myocardial infarction, the correlation between the existence of this effusion during the acute phase with clinical parameters, biological, angiographic, therapeutic and with transmurality, extent, microvascular obstruction and intra myocardial hemorrhage found on mri made beyond one week and before the 3rd month of the constitution of the necrosis.


Eligibility criteria:
inclusion criteria: * patient between 18 and 90 years old * patient admitted to the acute or semi-recent phase (within the next fifteen days) of a myocardial infarction (primary or recurrent myocardial infarction) documented by a significant enzymatic release of troponin (threshold value at 100) in the course of: chest pain or shock, or flare-up of heart failure (left or global) or successfully resuscitated cardiac arrest, or paroxysmal ventricular arrhythmia with or without sus shift of the st segment on the input trace, with or without q wave of necrosis formed. this idm may or may not be complicated by a more or less abundant pericardial effusion of more than 10 mm in the left parasternal, which may in the extreme be the cause of tamponade; * subject affiliated or beneficiary of a social security scheme; * patient having signed the free and informed consent. exclusion criteria: * patient with a pericardial detachment of less than 10 mm, or only systolic; * patient who had a break-in during the primary angioplasty guide or complicated coronary dissection extravasation with secondary pericardial effusion; * patient with advanced chronic renal failure * patient unable to perform an mri (with a defibrillator or pacemaker). * known allergy to contrast agents, in particular gadolinium * claustrophobic patient; * protected patient: adult under guardianship or other legal protection, deprived of liberty by judicial or administrative decision; * pregnant or breastfeeding woman; * patient hospitalized without consent.
a maintenance study of mirikizumab in participants with moderately to severely active ulcerative colitis

Conditions: Ulcerative Colitis

Summary: the purpose of this study is to evaluate the efficacy and safety of mirikizumab as maintenance therapy in participants who completed as clinical responders in the prior 12-week induction study lucent-1 (nct03518086).


Eligibility criteria:
inclusion criteria: * have completed study aman (nct03518086), with at least 1 study drug administration and without early termination of study drug. * are willing and able to complete the scheduled study assessments, including endoscopy and daily diary entry. * if female, must meet the contraception requirements. exclusion criteria: * participants diagnosed with crohn's disease or inflammatory bowel disease-unclassified (indeterminate colitis) during the induction study aman (nct03518086). * participants with a bowel resection or other surgery for the treatment of uc during the previous induction study aman (nct03518086), or are likely to require surgery for the treatment of uc during study ambg. * participants with evidence of colonic dysplasia or have been diagnosed with cancer of the gastrointestinal tract during study aman (nct03518086). * participants diagnosed with clinically important infection including, but not limited to, hepatitis b, hepatitis c, hiv/aids, and active tuberculosis (tb) during the induction study aman (nct03518086). * participants who initiate a new prohibited medication during the induction study aman (nct03518086). * participants with certain laboratory abnormalities prior to start of ambg that would require permanent discontinuation from study drug.

Keywords: interleukin-23 (il-23) il-23p19 inflammatory bowel disease
effects of pancreaticoduodenectomy on glucose metabolism

Conditions: Diabetes Mellitus; Glucose Intolerance

Summary: pancreaticoduodenectomy (pd) involves removing the head of pancreas, duodenum, common bile duct, gall bladder, and/or distal stomach. in general, the postoperative changes are thought to be moderately severe, and about 20% of these patients go on to develop new clinical diabetes. pd-related factors of glucose metabolism will include removal of half of the pancreatic endocrine tissue, exclusion of the proximal small intestine, postoperative weight loss (on average, \~8% of body weight), and removal of putative diabetogenic factor in resected neoplasm. however, effect of removal of duodenum on glucose metabolism after pd has never been studied. the investigators plan to examine this issue by comparing fasting plasma levels of insulin, fasting plasma glucose, c-peptide, hba1c, homa-insulin resistance, glp-1 response after a standard meal, and body mass index (bmi) of patients before and after pd.

questionaire all studied patients will be requested to self-complete a detailed questionnaire that collects information on demographic data, including usual adult height and weight, and history of dm in first-degree relatives. existing medical conditions, including dm, duration of these medical problems, and current medications will also be inquired. the database will also include details of weight measured at the time of recruitment and body mass index (bmi), calculated as weight (kg)/height2 (m2). all studied patients will have fbg levels measured. patients receiving prescription antidiabetic medications for previously diagnosed dm will be classified as having dm regardless of their fbg value. among patients not reporting treatment for dm, classification of dm status will be based on the american diabetes association criteria; patients will be classified as having dm if the fbg level is ≧126 mg/dl (7 mmol/l), as having impaired fasting glucose (ifg) if their fbg is between 100 and 125 mg/dl (5.6-6.9 mmol/l), and as having normal fasting glucose (nfg) if their fbg value is ≦99 mg/dl (5.5 mmol/l). after withdrawal of anti-diabetic medications for 12 h, the patients were asked to fast overnight for 12 h, then were given 200 ml of formula (220kcal, 14g of protein, 28 g of carbohydrates, and 5 g of fat; modifast, stocksund, sweden) within 10 min through a ng tube on post-operative day 5 (proximal feeding group \[pfg\]) and a jejunostomy feeding tube (distal feeding group \[dfg\]) on post-operative day 6. the below parameter will be checked, including 1. homa insulin resistance assessment (homa-ir) 2. glp-1 3. gip 4. c-peptide 5. insulin 6. glucose

Eligibility criteria:
inclusion criteria: * patients receiving pancreaticoduodenectomy exclusion criteria: * history of pancreatitis * hepatic dysfunction (child-pugh \> 2) * renal dysfunction (serum creatinine concentration \> 3 mg/l, hemodialysis, or both) * pregnancy

Keywords: pancreaticoduodenectomy diabetes sugar metabolism
study of nimotuzumab and irinotecan as second line with recurrent or metastatic gastric adenocarcinoma

Conditions: Stomach Neoplasms

Summary: the trial aims to evaluate the efficacy and safety of adding nimotuzumab to irinotecan after failure of first-line treatment in recurrent or metastatic gastric adenocarcinoma with overexpression of egfr, and search for the effective biomarkers for nimotuzumab efficacy in gastric cancer.

the sample size was calculated using simon's 2-stage design. the first stage require at least 4 or more out of 19 patients to have a confirmed partial or complete response (assuming p1 = 0.30, p0 = 0.10, with alpha = 0.05 and beta = 0.2) before proceeding to the second stage, in which additional 36 patients were needed. if a total of 15 or more patients achieve a confirmed objective response, then the primary end-point would have been met. the predicted response rate in this study is at least 30%. blood and tissue samples are required to collect at baseline, response and disease progression.

Eligibility criteria:
inclusion criteria: * advanced unresectable or recurrent gastric or gastroesophageal junction adenocarcinoma patients which meet the following criteria: * willing to sign icf * above 18 years * kps score≥70 * expected survival time more than 90 days * subjects with egfr overexpression (2+ or 3+ in ihc) * with target lesions in spiral ct or mri examination within 30 days * subjects who experienced disease progression during first line or within 6 months after the last dose of first line therapy. the first line regimen must have contained a 5-fluorouracil based agent ,platinum agent and paclitaxel agent. * lab test of baseline meet following criteria * hemoglobin higher than 9.0g/dl * neutrophil higher than 1,500/mm3 * plt higher than 10.0 104/mm3 * bilirubin lower than 1.5 times of upper limit of normal range * ast,alt,alp lower than 2.5 times of upper limit of normal range * creatinine lower than upper limit of normal range * when patient has liver metastasis or bone metastasis, the value of ast,alt,alp could be within 5 times of upper limit of normal range exclusion criteria: * patients who have received irinotecan * patients who are allergic to irinotecan or nimotuzumab. * other active malignancy within the last 5 years * female patients who are in pregnancy or lactation and patients who are not willing to take contraception measures * investigator judge not eligible to this trial

Keywords: gastric adenocarcinoma egfr irinotecan nimotuzumab biomarker
pain relief for birth control implants insertion

Conditions: Contraception; Lidocaine

Summary: the aim of our study is to compare the analgesic effect of topical application of lidocaine-prilocaine cream and lidocaine infiltration during insertion of birth control implants


Eligibility criteria:
inclusion criteria: * female want use subcutaneous birth control exclusion criteria: * previous scar at side of insertion
gaining optimal osteoporosis assessments in long-term care (goal)

Conditions: Osteoporosis

Summary: the aim of this study is to disseminate the 2010 osteoporosis canada clinical practice guidelines, using a multi-faceted knowledge translation (kt) model, as kt aims to close the gap between knowledge generated from research and practice. the investigators' primary objective is to evaluate if this intervention can increase the percent of long-term care (ltc) residents receiving appropriate treatment for osteoporosis (i.e. treatment is considered appropriate for an individual over age 50 who has had a diagnosis of osteoporosis or a fragility fracture of the hip or vertebrae and those who have had more than one fragility fracture and is therefore considered high-risk). a secondary objective is to examine whether the intervention increases the percent of all ltc residents receiving vitamin d equivalent to ≥800 iu/day.

individuals who live in ltc are at high risk for osteoporosis and fractures, particularly hip fractures, which lead to pain and transfer to acute care. the investigators' previous work in ltc has shown that awareness and use of clinical practice guidelines in ltc are low. to successfully transfer knowledge, it is imperative to understand the needs of the ltc teams and to tailor kt interventions appropriately. interventions which focus on strategies to overcome barriers and on new ways to deliver and promote the uptake of best practices that are specific to both the learning needs of ltc health care providers and the operational/organizational culture in ltc are greatly needed. interdisciplinary teams who participated in the vitamin d and osteoporosis study (vidos) indicated several process barriers that may hinder the proper identification and treatment of fractures in ltc. there is a need to educate ontario ltc practitioners on the osteoporosis guidelines. the investigators' aim is to facilitate the uptake of osteoporosis canada 2010 clinical practice guidelines, across ontario ltc homes using the vidos multi-faceted kt model. furthermore, the investigators will have a greater emphasis on the implementation of guidelines which includes risk assessment and appropriate medication use.

Eligibility criteria:
inclusion criteria: * a minimum of 2 physicians for each ltc home served by a pharmacy provider exclusion criteria: * ltc homes that have only one prescribing physician

Keywords: long-term care knowledge translation
a rct of compound lidocaine cream to prevent postoperative agitation in patients with endotracheal intubation for ga

Conditions: Postoperative Agitation of Patients

Summary: the purpose of this study is to determine whether the compound lidocaine cream is effective in preventing postoperative agitation in patients with endotracheal intubation for general anesthesia.

this is a randomized controlled study. some parameters were provided by preliminary test, provided theα=0.05,and β=0.20, the sample size can be estimated to be 2000 by the open epi version 2.patients will be recruited on the basis of predefined criterias. a researcher will take charge of the recruitment. participants provide written consent and no financial incentives are provided. they are divided into experimental group and control group randomly. we need to collect their basic information including ages, genders, heights, weights, underlying diseases, surgical procedures and levels classified by asa. blood pressure, heart rate and other vital signs during the tube drawing process will be recorded. all the contents needed to be recorded had been compiled into a watch list with detailed instructions for filling in. all the personal information and observation records of participants will be kept in secret and only used for research. developing standard operating procedure and training all the researchers. a third party will assess the accuracy, completeness and representativeness of registry data. experimental data will be analysed with the help of statisticians.

Eligibility criteria:
inclusion criteria: * aged over 18 * selective operation patients with endotracheal intubation for general anesthesia exclusion criteria: * highly sensitive to local anesthetics of amide derivatives or anything else in compound lidocaine cream * congenital or idiopathic methemoglobinemia

Keywords: postoperative agitation endotracheal intubation general anesthesia
birth ball versus meperidine and haloperidol injection for pain relief during first stage of labour

Conditions: Parturition; Humanizing Deliver; Labor Pain; Natural Childbirth; Labor Onset; First Labor Stage

Summary: the study was performed at gregorio marañón hospital birth centre. a randomised clinical trial comparing the two methods of pain relief in the first time of labour was carried out. in this study, 110 women in the first stage of labour were allocated in two study groups by a randomised block design. one of them used the birth ball as a pain relief method,and the other one used pethidine and haloperidol injection.


Eligibility criteria:
inclusion criteria: * healthy pregnant women * women in the first stage of labour or women at induction of labour * fetal head in pelvis or whole amniotic membranes * must be able to understand spanish exclusion criteria: * intrapartum meconium * needed of continuous fetal monitoring * suspecte/compromise fetal wellbeing * morbidly obese women * unaccompanied women

Keywords: parturition humanizing deliver labor pain natural childbirth labor onset first labor stage birth ball meperidine pethidine
a four month home based tdcs study on patients with alzheimer's disease.

Conditions: Alzheimer Disease

Summary: the study is an open label study on patients with alzheimer's dementia using home based transcranial direct current (tdcs) stimulation. aims of the study is to investigate applicability and effect of treatment.

active tdcs of 2ma is applied via surface based electrodes daily for 30 minutes over a 4 month period. anodal electrode is placed over the left temporal lobe. participants is followed up by home visit and phone calls. cognitive tests are performed prior to the treatment period, right after finishing 4 months of treatment and 4 months after treatment is terminated.

Eligibility criteria:
inclusion criteria: * age 60-85. * fulfil diagnostic criteria of probable alzheimer's dementia. * participants has to live with a caregiver. * if medicated with cholinesterase inhibitors or memantine, a stable dose the last three months before inclusion is required. exclusion criteria: * implant in head * seizure history * severe illness, * psychosis or depression measured with a cornell score over 11. * mini mental status (mmse) score\<17.
a master protocol for orforglipron (ly3502970) in participants with obesity or overweight with and without type 2 diabetes

Conditions: Obesity; Overweight; Type 2 Diabetes

Summary: the purpose of this master protocol is to support two studies to see how well and how safely orforglipron works compared to placebo in participants who have obesity or overweight with or without type 2 diabetes. participants will be screened for about 4 weeks, after which they will enroll into either j2a-mc-gzp1, nct06972459 (do not have type 2 diabetes) or j2a-mc-gzp2, nct06972472 (have type 2 diabetes).


Eligibility criteria:
there are no specific eligibility criteria for the master protocol. * see study gzp1 for eligibility criteria relevant to participants with obesity and overweight without type 2 diabetes * see study gzp2 for eligibility criteria relevant to participants with type 2 diabetes
effect of intracuff alkalinized lidocaine on coughing incidence at extubation

Conditions: Coughing; Extubation; Lidocaine; Endotracheal Cuff

Summary: the purpose of the study is to determined whether the administration of alkalized 4% lidocaine (160 mg) in the endotracheal tube cuff is effective in diminishing the incidence of coughing at extubation in surgeries lasting more than 2 hours without the use of nitrous oxide as an anesthetic agent.

the diffusion of nitrous oxide inside the endotracheal cuff leads to increase pressure, pain and coughing. studies have shown benefit of alkalized lidocaine and other mediums within the cuff with nitrous oxide. no study has yet evaluated the benefit of alkalized lidocaine in long surgeries without the use of nitrous oxide.

Eligibility criteria:
inclusion criteria: - asa 1,2 or 3 patients requiring general anesthesia for an elective urological or gynecological surgery predicted to last more than 2 hours exclusion criteria: * patient refusal * lidocaine allergy * any allergies to drugs or anesthetics used during the study * under 18 years of age * pregnant * previous airway surgery * cormack 3 or 4 or anticipated difficult airway * upper respiratory tract infection in the last month * active respiratory disease * chronic cough or throat pain * gastro-esophageal reflux disease or at risk for aspiration

Keywords: impact of alkalized lidocaine on coughing at extubation
dose efficiency of modern ct scanners in oncologic scans

Conditions: Neoplasms; Neoplasm Metastasis; Metastatic Cancer

Summary: ct-staging is crucial for therapy planning of patients with malignancies. dose efficiency and image quality are important parameters for these examinations. up to now, scientific evidence of dose efficiency of modern ct scanners is mostly derived from retrospective analyses. this prospective study systematically analyzes dose efficiency and image quality of three modern ct scanners by randomization of patients who are scheduled for a ct scan to examine the status of malignancies. after giving informed consent and randomization (1:1:1), the ct scan will be performed at one of the modern ct scanners available at our department. this will allow a systematic allocation to the different scanners.


Eligibility criteria:
inclusion criteria: * clinical suspicion of a malignancy or known / confirmed malignancy and * indication for contrast-enhanced ct of the body confirmed by board-certified radiologist ('justifying indication' according to german/european radiation protection law) and * patient (is able to give informed consent and) has given informed consent. exclusion criteria: * age \< 18 years * known or suspected pregnancy * contraindications for contrast agent (renal failure, allergy, hyperthyroidism)

Keywords: spectral ct ct computed tomography radiation dose dose efficiency