Kornimate/medical-research-clean huggingface dataset:
feasibility study of a protocol to treat pediatric oral mucositis by low-level laser therapy

Conditions: Oral Mucositis

Summary: low level laser therapy has been used for a few years in some pediatric hospital centers for chemo- and radiotherapy-induced oral mucositis care. it may promote ulceration's healing, limits mucositis severity and associated pain. as its use is recommended in the treatment of radio induced mucositis in adults, the level of evidence in pediatric studies does not allow a precise treatment protocol. the investigators present here the protocol of a feasibility study in the haemato-oncology department of the children university hospital of toulouse, with the view to a future efficacy study.

this study aims to evaluate the feasibility of using low level laser therapy (lllt) in the haemato-oncology department of the children university hospital of toulouse. the feasibility will be considered as acceptable if 60% of patients hospitalized for oral mucositis had successfully benefit from the procedure. the secondary objectives are the evaluation of efficacy of lllt on pain and mucositis grade, the evaluation of tolerance of this treatment and the medical time needed for this supportive care. the athermic phototherapy laser diode will be used by scanning the entire oral mucosa area. it will be applied uniformly every two days as long as grade of mucositis is 2 or more, with a fluence of 4j/cm², under two wavelengths (635 nm and 815 nm).

Eligibility criteria:
inclusion criteria: * hospitalization in the oncology ward of the university hospital toulouse france * onco-haematological paediatric patients treated by radio- and /or chemo-therapy, affected by an oral mucositis of who grade 2 to 4, * lack of any physical or psychological disease which could interfere with the realization of the study. exclusion criteria: * onco-haematological paediatric patients treated by radio- and /or chemo-therapy, affected by an oral mucositis of who's grade under 2 * child suffering from epilepsy * patient wearing a cardiac pacemaker * patient not able to open their mouth at least 20 mm * patient refusing the wearing of safety goggles.

Keywords: low level laser therapy oral mucositis child
a positron emission tomography (pet) study evaluating brain metabolism of a medical food in alzheimer's disease

Conditions: Alzheimer Disease

Summary: this study will examine the brain metabolic effects of ac-1202 (axona®), a medical food for alzheimer's disease. subjects who meet entry criteria will undergo h215o positron emission tomography prior to and 90 minutes after consumption of axona® at baseline and then again after 45 days of treatment. cognitive testing will also be conducted at baseline and day 45.


Eligibility criteria:
inclusion criteria: * diagnosis of probable ad (ninds-adrda criteria(32)) * age 50 - 90 (inclusive) * mmse range: 10 to 28 * participants may be taking medications for ad, provided that the dose of these medications has been stable for \> 90 days * proficiency in english to be able to perform cognitive tests * a caregiver must be available to monitor and administer treatment and to accompany the subject to every clinical visit. exclusion criteria: * inability for any reason to undergo pet/ct scans * previous treatment with ac-1202 * allergic to milk or soy * presence of neurodegenerative disease other than ad * history of stroke or other injury that could result in cognitive impairment * psychiatric disorder * diabetes mellitus * recent (\<90 days) changes to medications prescribed for cognitive reasons or with the potential to impact cognition * irritable bowel syndrome (ibs) or other gastrointestinal conditions that could interfere with treatment compliance * any factor deemed by the investigator to be likely to interfere with study conduction

Keywords: dementia
post- thoracotomy paravertebral block

Conditions: Pain, Postoperative

Summary: postoperative pain is the most undesired consequence of surgery, and if not managed adequately, can lead to delayed recovery and increased hospital stay. surveys continue to reveal that postoperative pain is insufficiently managed throughout the first world, let alone in the third world. an american survey over 20 years showed that only one in four patients had adequate relief of postoperative pain. this has led recovery room protocols to include pain as a fifth vital sign that needs to be addressed before patients are discharged to the ward

this prospective, randomized, double-blinded, parallel assignment clinical trial will be done after receiving approval from the local ethics committee of the faculty of medicine, assiut university. a written informed consent will be taken after discussing a detailed description of the study with the patients. patients will be allocated randomly into two equal groups by computer programs and will be contained in sealed opaque envelopes. patients will be premedicated with midazolam (0.1mg/kg), 30 min before the operation. patients will be monitored with ecg, non-invasive blood pressure, heart rate, temperature, oxygen saturation, exhaled co2 (end tidal capnography), and train of four. in both groups, general anesthesia will be induced with propofol (2mg/kg) and fentanyl (1 mcg/kg). tracheal intubation will be facilitated with cisatracurium 0.1 mg/kg. anesthesia will be maintained with isoflurane (1-2 %) and cisatracurium (0.05 mg/kg per dose). fentanyl (0.5mcg/kg) will be repeated if heart rate (hr) and/or mean arterial pressure (map) rise 20 % above baseline values. after the end of anesthesia induction and before surgical procedure technique of ultrasound guided paravertebral block will be done in both groups.

Eligibility criteria:
inclusion criteria: 1. asa i, ii and iii. 2. in the age ranged between 18 up to 60 years. 3. elective video-assisted thoracoscopy exclusion criteria: 1. asa iv and v 2. liver impairment 3. renal impairment 4. allergy to the drugs used 5. known contraindication for regional techniques such as: * infection near the site of the needle insertion * coagulopathy * anti-coagulation therapy,

Keywords: dexmedetomidine bupivacaine ultrasound guided paravertebral block pain post-thoracotomy
comparison of diagnostic accuracy before or after stricture dilation in biliary stricture

Conditions: Biliary Strictures

Summary: biliary strictures present a diagnostic and therapeutic challenge to clinicians due to unsatisfied accuracy of sampling modality. the major problem is very difficult to discern malignant from non-malignant strictures, such as patients with primary sclerosing cholangitis (psc). with the poor prognosis and high mortality rate of advanced stage of hepatopancreaticobiliary malignancies, early and accurate diagnosis impacts patients' outcome and possible surgical candidacy. therefore, a pre-operative determination of malignancy to help plan appropriate treatment is highly desirable. before 2000s, several diagnostic modalities, including laboratory tests, ultrasonography (us), computed tomography (ct) scan, cholangiography by percutaneous transhepatic cholangiography endoscopic (ptc) and endoscopic retrograde cholangiopancreatography (ercp), and brushing cytology disclosed 13% to 24% false positive rate for suspicious malignant hilar strictures. compared to recent studies, ercp brushings still suffer from low sensitivity (41.6% ± 3.2% (99% ci)) and negative predictive value (58.0% ± 3.2% (99% ci)). in order to increase diagnostic accuracy, at least two sampling methods, including brushing cytology, biopsy, and fine-needle aspiration is therefore recommended. one article showed multimodal tissue-sampling (brushing + biopsy + fine-needle aspiration) increased the sensitivity for diagnosis of malignant biliary stricture to 62%. however, no any literature demonstrate the best sequence of combined sampling modalities to yield the highest diagnostic accuracy. besides, the role of stricture dilation before or after different tissue sampling modality is still uncertain. in this study, the investigators want to compare stricture dilation before or after multimodal tissue-sampling, including brush cytology, intraductal suction and forceps biopsy for the diagnosis of malignant biliary stricture and also assess which kind of the sequence of combined tissue-sampling modalities could offer the highest diagnostic accuracy.


Eligibility criteria:
inclusion criteria: * clinically suspicious biliary stricture that required tissue sampling as medically indicated were considered for the study exclusion criteria: * biliary stricture caused by extra-luminal compression, such as pancreatic cancer and lymphadenopathy * contraindication for ercp study * age younger than 20 years * prior tissue sampling had yielded a diagnosis of malignancy * a guidewire could not be passed through the stricture * less than 6-month follow-up was available for patients with negative tissue sampling
risk factor of pod and pocd after cardiac surgery

Conditions: Postoperative Delirium; Postoperative Cognitive Dysfunction

Summary: postoperative delirium (pod) and postoperative cognitive decline (pocd) are common after surgeries in the elderly, especially after cardiothoracic surgery. these conditions are associated with adverse short- and long-term outcomes. multiple conditions in the perioperative period have been proposed as risk factors of pod and pocd. incidences vary across institutions due to differences in screening and diagnostic tools.

this is a prospective observational study to identify the incidences and risk factors of postoperative delirium and postoperative cognitive decline after elderly patients undergoing cardiac surgical procedures which require cardiopulmonary bypass and postoperative intensive care unit (icu) admission. patients will be screen for pod and pocd with various psychological tests in the postoperative period and after hospital discharge. perioperative data and outcomes will be used to identify risk factors of both conditions.

Eligibility criteria:
inclusion criteria: * age 65 years old or older * undergoing open heart surgery (cardiopulmonary bypass assisted cardiothoracic surgery exclusion criteria: * unable to communicate * severe visual or hearing impairment

Keywords: cardiac surgery perioperative care postoperative delirium postoperative cognitive dysfunction
surgical vs. lifestyle in obese older adults

Conditions: Obesity

Summary: the study aims are 1. to demonstrate the feasibility of recruiting and enrolling 10 subjects aged 55-75 planning to undergo sleeve gastrectomy and enrolling 10-20 (1-2 per surgical patient) matched subjects to the described intensive lifestyle intervention. 2. to collect preliminary data on the comparative effectiveness of the two interventions on physical function, weight loss, body composition, bone density and qol.

the investigators propose a 1-year pilot feasibility study to examine the comparative effectiveness of sleeve gastrectomy compared to an intensive lifestyle intervention of a high protein low carbohydrate, hypocaloric weight loss diet combined with exercise training among older adults aged 60-75. for pragmatic and ethical reasons, the investigators are employing a nonrandomized design. the investigators will recruit 10 older patients undergoing sleeve gastrectomy and match, recruit, and enroll 1-2 subjects to the lifestyle intervention for each surgical subject. the investigators will assess physical function, weight loss, body composition, bone density, qol and adverse events/health utilization at baseline and 6 and 12 months.

Eligibility criteria:
inclusion criteria: * patients must be aged 55-75 at the time of recruitment, * speak english, * meet medical eligibility criteria for wls (i.e. bmi of \>40 or \>35 with a major obesity comorbidity), * and be willing and able to participate in study procedures including the physical activity intervention and complete follow-up. exclusion criteria: the investigators will exclude participants for whom * intentional weight loss might be inappropriate (e.g. patients with serious life-limiting illness) * or who might be psychologically unstable (e.g. moderate to severe depression on the phq-9) * or who have contraindications to a high protein diet or the physical activity intervention (e.g. recent mi/cva in last 6 months, uncontrolled congestive heart failure, serum creatinine \> 2.0 mg/dl/on dialysis, h/o celiac disease/crohn's disease/ulcerative colitis.) * or patients whose weight exceeds 450 lbs (weight limit of dxa). * the investigators will withdraw bariatric subjects who do not undergo weight loss surgery and his or her matched lifestyle subject. the investigators will withdraw subjects in the lifestyle group who do not attend at least attend two of the first three nutrition and physical therapy visits. the investigators will recruit additional subjects to replace lifestyle subjects who are withdrawn from the study for this reason.
a retrospective analysis of spinal anaesthesia for turbt procedures in elderly patients

Conditions: Spinal Anaesthesia; Bladder Tumor; Transurethral Resection

Summary: the aim of the study was to evaluate the safety and effectiveness of spinal anesthesia among elderly patients the basic methods for diagnosis and management of bladder cancer include endoscopic procedures (cystoscopy, trans-urethral resection of bladder tumour turbt). the age of most patients is above 60, which increases the risk of complications during the perioperative period. usually the leading anaesthesia method in turbt procedures is regional, mainly spinal, anaesthesia. although the prevalence of regional upon general anaesthesia is questioned, certain positive aspects of regional anaesthesia are indisputable. maintaining logical communication with a patient during the procedure enables early diagnosis of complications (tur syndrome, bladder perforation). undeniably, regional anaesthesia ensures the best pain management in the early post-operative period. the simplicity of performing an efficacious spinal block and its cost-effectiveness are additional factors, which have contributed to the acknowledgement of the method as the standard of anaesthesia for transurethral procedures.


Eligibility criteria:
inclusion criteria: * turbt procedure * spinal anaesthesia * age over 60 exclusion criteria: * general anaesthesia

Keywords: spinal anaesthesia elderly patients transurethral resection of bladder tumour
hfpef and 2-year mortality of copd patients

Conditions: Chronic Obstructive Pulmonary Disease; Heart Failure

Summary: this study was designed to assess potential relationship between heart failure with preserved ejection fraction and 2- year mortality of patients with chronic obstructive pulmonary disease


Eligibility criteria:
inclusion criteria: exacerbation of chronic obstructive pulmonary disease requiring hospitalization age 40 - 80 years performance status 0-1 according to eastern cooperative oncology group (ecog) long acting beta agonist (laba)/ long acting antimuscarinic (lama) bronchodilator treatment exclusion criteria: presence of major heart valve dysfunction documented noncompliance with treatment presence of active malignancy body mass index \> 40 interstitial lung disease
assessment of vzv-specific elispot assay for predicting vzv infection in kidney transplant recipients (ave-kt)

Conditions: Kidney Transplantation

Summary: vzv is one of the important opportunistic infection in transplant recipients.until now, there is no laboratory method to stratify the risk of vzv reactivation after solid organ transplantation. theoretically, vzv-specific cell-mediate immune response before solid organ transplantation will further categorize the patients into high or low risk of vzv development after solid organ transplantation. the investigators thus evaluate the usefulness of vzv-specific elispot assay in kidney transplant candidates to predict the development of vzv infection after kidney transplantation.

we will develop vzv-specific elispot assay, then perform this assay before transplantation. we will evaluate whether this assay will predict zoster reactivation after transplantation.

Eligibility criteria:
inclusion criteria: * age 16 years or more * agree with written informed consent * wbc count 2000/ul or more exclusion criteria: * no exclusion criteria
bioequivalence study of 2 sizes of shr4640 tablets orally in healthy subjects

Conditions: Hyperuricemia

Summary: the study is being conducted to evaluate the pharmacokinetic, and safety of two sizes of shr4640 tablets in healthy adults, to explore the bioequivalence between two sizes of shr4640 tablets.


Eligibility criteria:
inclusion criteria: 1. able and willing to provide a written informed consent. 2. 18 years to 45 years (inclusive). 3. body weight should above 45 kg, and body mass index should be between 19 and 28 kg/m2 (inclusive). 4. the physical examination, vital signs, laboratory examination and electrocardiogram are not abnormal or abnormal but with no clinical significance. exclusion criteria: 1. pregnant or nursing women. 2. no birth control 1 weeks before screening or until one week after shr4640 administration. 3. average daily alcohol consume more than 14g for female or more than 28g for male within 1 month before screening, or baseline alcohol screening is positive. 4. smokers (average daily smoking of 5 cigarettes or more in the 3 months before screening). 5. subject with a history of substance abuse and drug abuse. 6. the investigators determined that other conditions were inappropriate for participation in this clinical trial. 7. sua level ≥480 μmol/l. 8. egfr \< 90 ml/min/1.73 m2. 9. positive result for human immunodeficiency virus (hiv), hepatitis c virus antibody, or syphilis antibody, or hepatitis b surface antigen. 10. 12-lead electrocardiogram (ecg) showed abnormal and clinically significant. 11. cardiovascular, neuropsychiatric, respiratory, digestive tract, endocrine and other systemic diseases within 1 year before screening, which were judged to be serious by the investigators. 12. history of hypersensitivity to shr4640 or its analogues. 13. history or suspected crystals or stones in the urinary system during the screening period of b-ultrasound. 14. history of been diagnosed with acute kidney injury in the past or screening period. 15. had undergone major surgery within 3 months prior to screening, or have not recovered from surgery, or plan major surgery during the study. 16. blood donation within 1 month before screening; or patients with trauma or major surgical procedures who donated blood or lost blood \> 400 ml in the 3 months prior to screening. 17. has unsuitable venous for blood sampling. 18. received the last dose of a study drug (or treatment with a medical device) within 3 months or 5 t1/2 (whichever is longer) of the screening or are currently participating in another study of a study drug (or medical device). 19. have received or been exposed to other live vaccines or live attenuated vaccines within 3 months prior to day 1, or who plan to receive live vaccines or live attenuated vaccines during the study. 20. consumes grapefruit and/or poppy seed within 48 hours before shr4640 administration. 21. taken any prescription drugs, over-the-counter drugs, herbal medicines or food supplements within 2 weeks before screening.
an international survey on aminoglycoside practices in critically ill patients: amino iii survey

Conditions: Underdosing of Aminoglycosides; Critical Illness

Summary: this is an international observational cohort study on current aminoglycoside practices in intensive care units. clinical and demographic data, dosing and therapeutic drug monitoring data will be collected during the first week of aminoglycoside (tobramycin, amikacin or gentamicin) administration in different countries over a year. a minimum of ten consecutive patients will be enrolled at each site.

aminoglycosides are commonly used antibiotics for difficult to treat infections. however, aminoglycoside administration varies widely among countries. the aim of this multicenter observational study is to provide up-to-date and comprehensive descriptive data on current aminoglycoside (tobramycin, amikacin or gentamicin) use in a large cohort of critically ill patients in different countries. the benefits expected from this study are a better understanding of worldwide aminoglycoside prescription variability in critically ill patients and to determine the risk factors of inadequate aminoglycoside dosing regimens.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years old * intensive care unit patients * receiving aminoglycoside therapy for a sepsis according to the third international consensus definitions for sepsis and septic shock exclusion criteria: * aged \< 18 years of age * previous inclusion in the study

Keywords: antimicrobial intensive care units
neuromuscular training program in patients with knee oa (osteoarthritis)

Conditions: Knee Osteoarthritis

Summary: the aim of this study was to compare the effects of neuromuscular training program and conventional physical therapy program on pain, functional status, physical performance, balance, muscle strength and quality of life in patients with knee osteoarthritis (koa).

the study was carried out in afyonkarahisar health sciences university health application research center in individuals with 2nd or 3rd degree koa according to kellgren and lawrence classification. the study was planned as a randomized controlled clinical trial design. the study group were recruited to the neuromuscular training program and the control group were recruited to the conventional physical therapy program 5 days a week for 3 weeks. individuals were evaluated at the baseline and after training programs. demographic and clinical data were first recorded in the evaluation.

Eligibility criteria:
inclusion criteria: * having grade 2 or 3 osteoarthritis according to the kellgren and lawrence classification * having pain score of 2 or above on vas * not having received physical therapy in the last 3 months * not having received an intra-articular corticosteroid injection in the last 6 months * not having used oral corticosteroids in the last month * being between the ages of 40-80 * body mass index being between 19-40 kg/cm2 exclusion criteria: * systemic arthritis * hypertensive condition that prevents exercise * pregnancy, cognitive impairment, parkinson-like neurological disorders * having had a knee or hip joint replacement

Keywords: neuromuscular training knee osteoarthritis physical therapy