Kornimate/medical-research-clean huggingface dataset:
sodium citrate 4% locking solution for children requiring home parenteral nutrition

Conditions: CLABSI - Central Line Associated Bloodstream Infection

Summary: this study an open label prospective observational cohort study to evaluate the safety and efficacy of sodium citrate 4% locking solution in preventing central line associated blood stream infection in children requiring long term central venous catheters for home parenteral nutrition. sodium citrate 4% is fda-approved for dialysis catheters, but has not been formally evaluated for use in tunneled catheters for parenteral nutrition. the rate of central line-associated bloodstream infection (clabsi) and other potential adverse events will be monitored for 12 months, with the option to remain in the study for a longer period of time.

in this prospective observational cohort study of pediatric patients requiring home parenteral nutrition for intestinal failure, participants will be enrolled from the pediatric intestinal rehabilitation clinic, and data collection will be obtained from the electronic medical record. participant will receive daily sodium citrate 4% catheter locking solution for clabsi prophylaxis, instead of heparin locks. participants will be monitored for 12 months for adverse events, including clabsi. participants will have the same routine laboratory schedule and monthly outpatient follow up. after 12 months, participants will be given the option to continue to use sodium citrate 4% locks after the initial study period if no serious adverse events have occurred. the investigators anticipate enrolling 10-15 participants per year and anticipate enrollment to continue for 3-5 years. sodium citrate locks: 3 ml vials of locking solution will be prepared by the infusion pharmacy using commercially available 4% sodium citrate iv fluid (available in 500 ml bags). the sodium citrate locks will be instilled into the central catheter daily during the period that parenteral nutrition is not infusing, and will be withdrawn and disposed of prior to resuming infusion of parenteral nutrition. if subjects are hospitalized, sodium citrate locks will be temporarily held during the duration of the inpatient stay, and will be resumed once the participant is discharged home.

Eligibility criteria:
inclusion criteria: * pediatric patients (\<18 years) and adult patients (up to 21 years still in our clinic) * requiring long-term (\>3 months) home parenteral nutrition due to intestinal failure/short bowel syndrome * has had at least one central line-associated blood stream infection exclusion criteria: * known cardiac arrhythmias * hypersensitivity to citrate * pregnancy * receiving continuous parenteral nutrition (infusing over 24 hours)

Keywords: pediatric home parenteral nutrition intestinal failure
the role of short course of palliative radiation in metastatic cancer rectum

Conditions: Metastatic Cancer Rectum

Summary: short-course radiotherapy (scrt), which allows the delivery of 25 gy in five daily fractions, has emerged as an attractive strategy for rectal cancer treatment. surgery can safely be deferred after scrt, allowing an opportunity to deliver chemotherapy (cht) preoperatively rather than postoperatively. in cases of metastatic disease, this represents an effective treatment option to improve local control and avoid colostomy in a subset of patients.

all patients will be under go complete history and physical examination, proctoscopy and biopsy, followed by metastatic work up include chest x ray, pelvic abdominal ct. radiotherapy: target volume: all the gross primary disease and gross nodal involved plus 2 cm safety margin will be included. not involved node will not be included. dosage: total dose of 25 gy over 5 fractions through 1 weak will be given. time: radiotherapy will be given first and chemotherapy will be given after 1 weak rest to avoid the over lapping toxicity. chemo therapy: to be started after 1 weak rest after radiotherapy. capox (oxaliplatin given intravenously at 130 mg/m2 on day 1, followed by oral capecitabine 1000 mg/m2 twice daily on days 1-14, in a 3-week cycle). or folfox (leucovorin calcium (iv 200 mg/m2 on day 1,2,15,16 ) + 5 fluorouracil (iv 600 mg/m2 on day 1,2,15,16)+ oxaliplatin (iv 85 mg/m2 on day 1, 15) plus target agent according to ras status if wild for bevacizumab ( iv 5 ml/kg on day 1, 15) or cetiximab (iv 250 mg/m2 on day 1,8,15, 22) or vectibex (iv 6mg/kg on day 1,15) surgery: surgery if complete bowel obstruction as palliation or as treatment if controlled metastatic sites and primary follow up: ct pelvi-abdomen will be done after 3 cycle of chemotherapy to assess the response then after end of cth every 3 month in first year. toxicity of rth will be collected before and after rth.

Eligibility criteria:
inclusion criteria: 1. adenocarcinoma pathological evidence in rectal carcinoma. 2. metastatic unresectable rectal cancer. 3. symptomatic disease for at least one of the following signs: bleeding, pain, tenesmus, obstruction, exclusion criteria: 1. previous radiotherapy. 2. concomitant chemotherapy. 3. previously created stoma.
acute effect of neural mobilization in cervical radiculopathy: a randomized controlled study

Conditions: Cervical Radiculopathy

Summary: the aim of this study was to investigate the immediate effect of neural mobilization techniques, one of the manual therapy methods that can be used in the treatment of cervical radiculopathy.

this study was designed as a randomized controlled experimental study and was conducted in the physiotherapy and rehabilitation department of istanbul medicana international hospital. population: the study included patients diagnosed with cervical disc herniation who were referred to physiotherapy sessions by a physician patients were assigned to the control group(cg) or neural mobilization group(nmg) by simple randomization. the control group received conventional physiotherapy while the neural mobilization group received neural mobilization of the ulnar median and radial nerves. the pain of the patients was evaluated with numeric pain rating sacale (nprs) and neuropathic pain questionnaire (npq) at the beginning and end of the intervention, while hand grip strength and pinch grip strength were evaluated with digital hand dynamometer (jamar plus digital hand dynamometer) and digital pinchmeter (jamar plus pinch gauge). pre- and post-intervention data were statistically analyzed and compared.

Eligibility criteria:
inclusion criteria: * participants meeting the following criteria were included in the study: age between 18 and 65 years, referred to physiotherapy with a diagnosis of cervical disc herniation, self-reported neck pain with a visual analog scale (vas) score of more than 5, presence of pain radiating from the neck to the arm, and at least 3 of the following tests were positive: spurling's test, upper extremity tension test-1, distraction test, and ipsilateral cervical rotation less than 60 degrees. these tests were assessed by a trained examiner according to standardized procedures exclusion criteria: * exclusion criteria were surgical intervention in the head and neck region, history of fracture in the head and neck region, known chronic disease, infection and structural disorders in the bone and soft tissue in the cervical spine, malignancy and severe osteoporosis.

Keywords: neural mobi̇li̇sati̇on,cervi̇cal radi̇culopathy,
influenza vaccination in the emergency department

Conditions: Influenza

Summary: randomized controlled trial of influenza vaccination versus referral for vaccination in the emergency department. is the emergency department an effective venue for vaccination for influenza? does vaccination for influenza in the emergency department change the rates of influenza, influenza-like-illness or medical provider visits when compared with patient referred for vaccination in the community?

this study is a prospective randomized, controlled trial of influenza vaccination vs referral for influenza vaccination in the emergency department. subjects are either offered vaccination or education regarding vaccination and a list of community providers. at a four-month follow up, rates of influenza, influenza-like illness and number of medical provider visits are determined.

Eligibility criteria:
inclusion criteria: * unvaccinated patients presenting to the emergency department aged 6 months or more who have at least one high risk attribute: * age 6-59 months or \>50 years * pregnant * health care worker * aged 6 months-18 years on chronic aspirin therapy * comorbidity (cardiovascular disease, pulmonary disease, metabolic disease, renal disease, hepatic disease, seizures, neuromuscular disease, cognitive dysfunction, or any reason to have had regular medical follow up or hospitalization in the preceding year) * household contact or caregiver of someone with at least one high risk attribute exclusion criteria: * prior vaccination * history of guillan-barre syndrome within 6 weeks of prior influenza vaccination * allergy to influenza vaccination or eggs * age \< 6 months old * fever with more than minor illness * hospitalization

Keywords: influenza vaccination emergency department
external validation os the acme scoring system

Conditions: Acute Cholecystitis

Summary: acute calculous cholecystitis (acc) is the second most frequent surgical condition in emergency departments. the recommended treatment is surgical treatment (st) and the accepted mortality is \<1%, but in severe and/or fragile patients is higher. despite the tokyo guidelines, there no consensus on who is the unfit patient for st. a recent study has identified 4 risk factors that predicts the mortality in a 92% of patients (acme) and could help to develop new guidelines in acc. the aim of this study is to perfom an external validation of the new simplified scoring system for mortality in acc.

this is a prospective multicenter observational study of 10.000 adults with acc during 2 consecutive years (2025/2026), including baseline demographic characteristics, comorbidity severity defined as charlson comorbidity index (cci), asa score, tokyo guidelines severity classification and the new acme scoring system. the primary outcome is to study the prediction of mortality of acme score. secondary outcomes include complications following clavien-dindo's classification, c-statistic, and roc curves.

Eligibility criteria:
inclusion criteria: * acute calculous cholecystitis exclusion criteria: * acute cholangitis * chronic cholecystitis * neoplasia * acute pancreatitis * pregnant

Keywords: acute cholecystitis cholecystectomy tokyo guidelines postoperative complications mortality high-risk patient
penicillin allergy delabeling project

Conditions: Penicillin Allergy

Summary: a investigational study to establish: 1. a validated cllinical pathway for delabeling declared penicillin allergiy outside allergologic departments. 2. a survey to examine anesthesiologists attitudes and knowledge about penicillin delabeling. 3. a qualitative focus group study investigating barriers and facilitators in penicillin delabeling among hospital nurses and physichians. 2. implement the pathway for delabeling declared penicillin allergy outside allergologic clinics across the western norway health region.

patients labeled penicillin allergic is a significant and growing public health problem. 10% of all patients report penicillin allergy. 9 out of 10 however tolerate penicillin on provocation, to be labeled as penicillin allergic has several well documented negative health outcomes for the individual, and on a public health scale. one of the biggest obstacles in delabeling penicillin allergy is the lack of validated tools i norwegian, the lack of in vitro tests for severe late /t cell mediated reactions and the accessibility of the gold standard procedure, drug provocation test. in this study patients having a penicillin allergy label will after giving their written concent be screened used a risk stratification tool. the low risk patient will then directly undergo a single full dose amoxicillin challenge. high risk patients are refered to a allergologic clinic and undergoes full allergologic examination. the investigators seek to document that in low risk patients is a single dose amoxicillin challenge safe and beneficial outside an allergologic clinic, and to validate the risk stratification tool in norwegian. to implement such pathways i qualitative data is needed to facilitate the right efforts and translate the method into every day clinical practice in a sustainable way. here a anesthesiologist survey and focus group interviews with hospital nurses and physichians is planned. finally we will implement the method in an implementation study across the western norway health region

Eligibility criteria:
inclusion criteria: * penicillin allergy in the patient journal oder patient reported exclusion criteria: * not able to give concent. under 16 years of age.

Keywords: penicillin allergy clinical pathway implementation delabeling
pediatric sleep questionnaire: use for collection of clinical data

Conditions: Sleep Disorders

Summary: the purpose of this study is to develop a questionnaire that can be used for standardized patient information gathering in the clinical setting. this will serve as the information source for a pediatric sleep database.

a sleep questionnaire will be administered to patients who present to the pediatric neurology clinic and the pediatric sleep clinic in the dcam as well as larabida children's hospital complaining of sleep problems. the questions asked are those routinely obtained in clinical practice of sleep medicine. medical students, residents and faculty as part of their normal clinical responsibilities will administer the questionnaire. the database will be maintained in filemaker pro program for future research purposes. collection of the data will require approximately 15 minutes. a database file number not related to the patient medical record number will be assigned to each patient. the investigator will keep a separate log linking patient database number and patient medical record number. the logbook will be kept under lock and key by the investigator.

Eligibility criteria:
inclusion criteria: * all patients seen in the pediatric neurology clinic and at la rabida children's hospital exclusion criteria: * adults

Keywords: sleep disorders
lymphatic anomalies registry for the assessment of outcome data

Conditions: Lymphatic Malformation; Generalized Lymphatic Anomaly (GLA); Central Conducting Lymphatic Anomaly; CLOVES Syndrome; Gorham-Stout Disease ("Disappearing Bone Disease"); Blue Rubber Bleb Nevus Syndrome; Kaposiform Lymphangiomatosis; Kaposiform Hemangioendothelioma/Tufted Angioma; Klippel-Trenaunay Syndrome; Lymphangiomatosis

Summary: lymphatic anomalies are a rare subset of vascular anomalies that are poorly understood. the understanding of the natural history, long-term outcomes, risk factors for morbidity and mortality, and the relative benefit of medical therapies and procedures is limited.the goal of this project is to better understand these diseases and improve the care of theses rare patients. to do this, the investigators are conducting an observational study of patients with lymphatic anomalies, including an annual follow-up questionnaire to gather prospective data on mortality, morbidity, treatments, and functionality as well as quality of life.

the purpose of the lymphatic anomalies registry, created at boston children's hospital, is to create a database to help current and future patients diagnosed with a lymphatic anomaly. the ultimate goal of the registry is to better understand and predict responses to therapies and risk factors for complications. although the lymphatic anomalies registry exists at boston children's hospital, patients can be entered into the registry regardless of whether or not they visit boston children's hospital, thus increasing the program's accessibility. the lymphatic anomalies registry includes patients who have vascular anomalies with a lymphatic component across various diagnoses. from the patient's perspective, participation in the lymphatic anomalies registry means taking part in a short, thirty minute interview, and providing the registry with access to medical records. the interview is conducted verbally with study staff of the lymphatic anomalies registry, and can take place either at the hospital, or over the phone. during the interview, the registry will inquire about the patient's diagnosis, disease features, medical therapies, and procedures. interested prospective patients will receive an introductory packet from the registry with information on how to proceed in the registry process. all obtained patient information is housed on a secure, hippa compliant, internal database, managed by boston children's hospital staff. patient information entered into the external database is de-identified. the research teams will also obtain a medical record release form to request the patient's medical record for review in our study.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of complex vascular tumor, malformation or overgrowth syndrome with significant lymphatic component

Keywords: vascular anomalies lymphatic anomalies lymphatic malformation
efficacy and safety of summers non-pesticide lice asphyxiator (l.a.)for the treatment of head lice.

Conditions: Head Lice

Summary: this is a multi-center, randomized, double blind, vehicle controlled, study designed to evaluate the pediculicidal activity of summers 5% l.a. compared to a vehicle control.


Eligibility criteria:
inclusion criteria: 1. males and females 6 months of age or older. 2. have an active infestation with pediculus capitis, the human head louse, with at least three live lice at baseline. 3. agree not to use any other pediculicides or medicated hair-grooming products during the duration of the study. 4. be healthy, non-febrile, and not suffering from an infection likely to require antibiotic therapy during the study period. 5. subject or guardian is able to understand the new hipaa regulations and sign the hipaa form. 6. subject or guardian has read, understood, and signed appropriate informed consent in english. if english is not the primary language, the information about the study must be explained in their language and a copy of the informed consent must be in that language. 7. subject is willing to participate in the study, and abide by the protocol requirements. - exclusion criteria: 1. participation in any clinical study within the past 30 days. 2. known hypersensitivity to any ingredient in the product formulation.
safety and efficacy of aliskiren on the progression of atherosclerosis in coronary artery disease patients

Conditions: Coronary Artery Disease (CAD); Coronary Atherosclerosis

Summary: the study will assess the change in coronary atherosclerotic disease as determined by intravascular ultrasound (ivus) for aliskiren compared to placebo when given in addition to standard therapy in patients with coronary artery disease (cad) and a blood pressure in the pre-hypertensive range.


Eligibility criteria:
inclusion criteria: * patients with cad who have blood pressure in the pre-hypertensive range defined as a mssbp ≥ 125 and ≤ 139mmhg and a msdbp \< 90mmhg. * patients with or without current treatment for hypertension * angiographic evidence of coronary artery disease * at least 2 qualifying cardiovascular risk factors at visit 1 exclusion criteria: * baseline ivus determined unacceptable * patients requiring treatment with disallowed study medications * patients with clinically significant heart disease * previous or current diagnosis of heart failure (nyha class iv) or a documented left ventricular ejection fraction of \< 25% * patients requiring treatment with any 2 of the following classes of medication at visit 1 or visit 2: * angiotensin converting enzyme inhibitors * angiotensin receptor blockers * aldosterone receptor blockers or a direct renin inhibitor. * other conditions may apply

Keywords: cad coronary artery disease coronary atherosclerosis coronary angiography ivus intravascular ultrasound plasma renin activity renin angiotensin aldosterone system, direct renin inhibitors coronary atheroma
a phase ib study with pegylated recombinant human endostatin in advanced / metastatic nsclc or other solid tumors

Conditions: NSCLC; Solid Tumor

Summary: the primary purpose of this study is to examine the safety, tolerability and pharmacokinetics of peg-endo in combination with docetaxel in subjects previously treated or untreated (standard therapy is not suitable or without standard therapy) for advanced or metatatic non-small cell lung cancer (nsclc) or other solid tumors.

this is a multicenter, open-label, dose-escalation study in subjects with advanced or metatatic non-small cell lung cancer (nsclc) or other solid tumors.there will be five cohorts planning as following: cohort 1: peg-endo 1 mg/kg+docetaxel 75 mg/m2,once every 3 weeks at day 1 cohort 2: peg-endo 2mg/kg+docetaxel 75 mg/m2,once every 3 weeks at day 1 cohort 3: peg-endo 4 mg/kg+docetaxel 75 mg/m2,once every 3 weeks at day 1 cohort 4: peg-endo 6 mg/kg+docetaxel75 mg/m2,once every 3 weeks at day 1 cohort 5: peg-endo 8 mg/kg+docetaxel75 mg/m2, once every 3 weeks at day 1 \* every 3 weeks as a treatment cycle. subjects received only peg-endo in the first cycle. for second cycle or the higher, they received a combination therapy of peg-endo and docetaxel. docetaxel was limited in 4 or 6 cycles。 the observation period of dlt was the 21 days after the first administration of peg-endo. during the observation period of dlt (cycle 1), subjects only receive the corresponding dose of peg-endo , for the second cycle and higher ,they will treated with the combination of peg-endo and docetaxel until disease progression (pd) or intolerance . docetaxel was limited in 4 or 6 cycles。

Eligibility criteria:
inclusion criteria: 1. provision of signed and dated, written informed consent. 2. 18-70years old, male or female. 3. histological or cytological confirmation diagnosis of non small cell lung cancer(nsclc) or other solid tumor, previous treated with standard therapy , or standard therapy not suitabl ,or without standard therapy. 4. at least one measurable disease according to recist v1.1. 5. life expectancy of at least 3 months. 6. eastern cooperative oncology group (ecog) performance score 0 or 1. 7. demonstrate adequate organ function - exclusion criteria: 1. uncontrolled primary cns tumors, brain metastases, or meningeal metastases. 2. evidence of a tumor that compresses or invades major blood vessels. 3. history of hemoptysis (\>1/2 teaspoon per event) or severe bleeding or evidence of bleeding disorders in the last 3 months. 4. clinically significant active cardiovascular disease within 6 months prior to planned start of peg-endo. 5. prior treatment with anti-agiogenetic agent. 6. pregnant female patients; breastfeeding female patients. -

Keywords: pegylated recombinant human endostatin (peg-endo)