Kornimate/medical-research-clean huggingface dataset:
a study of palifermin for the reduction of oral mucositis in subjects with locally advanced head and neck cancer receiving postoperative radiotherapy

Conditions: Head and Neck Cancer

Summary: the purpose of this study is to evaluate the efficacy, safety and tolerability of palifermin on the incidence of oral mucositis in subjects with locally advanced head and neck cancer receiving postoperative radiotherapy.


Eligibility criteria:
inclusion criteria: * history of newly diagnosed histologically confirmed squamous cell carcinoma (ajcc stage ii, iii or iva) involving either the oral cavity, oropharynx, hypopharynx, larynx and post surgical resection (r0 or r1) * candidates for postoperative rt-only treatment and scheduled to receive rt within 12 weeks of surgery * eastern cooperative oncology group (ecog) performance status less than or equal to 2 * urinary protein-creatinine ratio (random sample, spot pcr) ≤ 0.2 mg/mg exclusion criteria: * tumors of the lips, paranasal sinuses, salivary glands, or of unknown primary tumors and r2 resection margins * metastatic disease (m1) * presence or history of any other primary malignancy, other than curatively treated in situ cervical cancer, or basal cell carcinoma of the skin without evidence of disease for \> 3 years * history of pancreatitis * prior radiotherapy to the site of disease * prior chemotherapy or requiring chemotherapy during treatment phase of study * prior treatment with palifermin, or other fibroblast or keratinocyte growth factors

Keywords: oncology kgf hnc head and neck oral mucositis om proteinurea palifermin clinical trial
resistant bacterial infections in the early post ldlt period

Conditions: Transplantation Infection

Summary: the purpose of this work was to study the incidence, types, risk factors and causative organisms of bacterial infections in hcv egyptian patients following liver transplantation. moreover, to identify the emerging resistant strains and their proper antimicrobial therapy

this prospective descriptive study has been done at tropical medicine department in the period between january 2014 to november 2015. after the approval of the scientific and ethical committee of ain shams university hospital, patients with hcv positive end stage liver disease (esld) eligible for liver transplantation ain shams center for organ transplant (ascot); ain shams university, (fulfilling the inclusion criteria) were included in the current study. forty five patients were recruited and each one was followed-up during a period of 3 months following transplantation. included patients were divided into 2 groups: group 1 included patients who had a postoperative single episode of infection. group 2 included those patients who had more than 1 episode of postoperative bacterial infection whom were further evaluated for the presence of emerging strains and/or antibiotic resistance.

Eligibility criteria:
inclusion criteria: * egyptian nationality. * accepting participation in the current study and signing a written consent form * age between 18-60 years, including males and females. exclusion criteria: * patients who refused to be enrolled in the study. * patients with other etiologies for end-stage liver disease (hbv, pbc...) * patients with preoperative infections, infections within 48 h after transplantation or early post-operative death
laboratory diagnosis and prognosis of severe dengue

Conditions: Dengue Fever

Summary: a study of dengue in children presenting to outpatient departments of 5 large hospitals in ho chi minh city and tien giang province, viet nam. different blood tests are compared at the early stages of dengue fever onset in their ability to accurately and specifically detect children whose dengue will progress to severe disease.

in a prospective study in the outpatients department of three large hospitals in ho chi minh city, viet nam, we will determine the early diagnostic sensitivity, specificity, positive and negative predictive values of two ns1 diagnostic tests in severe dengue cases. the study is intended to develop a prognostic algorithm for the early identification of severe dengue cases. routine demographic, haematological and biochemical laboratory markers will be utilized to derive a prognostic algorithm that is clinically-useful for guiding patient triage and interventions. we hope to discover and evaluate new early biomarkers of severe dengue and will evaluate candidate host response molecules and virological markers for their prognostic value. we further plan to understand the phylogeography of denv in the super-urban setting of hcmc. we will use genome scale sequencing of denv together with geospatial information on the residential addresses of patients to better understand transmission dynamics in space and time in a high transmission super-urban district of hcmc and thereby identify opportunities for public health interventions.

Eligibility criteria:
inclusion criteria: * clinical suspicion of dengue * axillary temperature \>=37.5c * less than 72hrs of fever * resident in ho chi minh city * 1-15 yrs of age * accompanying family member or guardian has a mobile phone * written informed consent exclusion criteria: * any patient who the attending physician believes is unlikely to be able to attend follow-up * any patient in who the attending physician believes another diagnosis is more likely.

Keywords: dengue fever severe dengue fever ns1 detection assay prognosis diagnosis
the effect of empagliflozin on glucose metabolism, weight, blood pressure and cardiac function (nt-probnp) should be investigated

Conditions: Diabetes Mellitus, Type 2

Summary: in summary, the registry should provide novel insight into potential mechanisms of cardiovascular risk reduction in patients treated with empagliflozin with an indication of intensified glucose lowering therapy based on their hba1c level.

patients with diabetes exhibit an increased risk for the development of cardiovascular disease with a significantly impaired prognosis compared to patients without diabetes. recent data from the empa-reg outcome trial suggest that treatment with the sglt-2 inhibitor empagliflozin reduces cardiovascular events, cardiovascular mortality as well as hospitalization for heart failure in patients with type 2 diabetes and pre-existing cardiovascular disease. empagliflozin leads to reduction of blood glucose by an increased glucose excretion reduces blood pressure and weight. still, it remains unclear how empagliflozin led to this pronounced reduction of cardiovascular mortality the empa-reg outcome trial. thus, our registry will analyse various biochemical as well as clinical markers in patients with type 2 diabetes and newly initiated treatment with empagliflozin. and an indication for intensification of glucose lowering therapy with empagliflozin. patients with an indication for an intensified glucose-lowering therapy (hba1c \> 7,5%) will receive 10 mg empagliflozin and we will perform biochemical analyses of blood samples including insulin, glucagon as well as metabolites at baseline as well as after 1 and 6 months. in addition we will assess echocardiographical data.

Eligibility criteria:
inclusion criteria: * diabetes mellitus ii patients with whom an empagliflozine treatment is to be initiated from a clinical indication exclusion criteria: * inability to consent to the study
tiotropium+olodaterol fixed dose combination (fdc) in chronic obstructive pulmonary disease (otemto 2)

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: the objective of this study is to assess the efficacy and safety of 12 weeks once daily treatment with orally inhaled tiotropium + olodaterol fdc (delivered by the respimat inhaler) compared with tiotropium and placebo in patients with copd.


Eligibility criteria:
inclusion criteria: * diagnosis chronic obstructive pulmonary disease * relatively stable airway obstruction with post fev1 \>=30 and \< 80% predicted normal and post fev1/ fvc \< 70% * male or female patients, 40 years of age or more * smoking history more than 10 pack years exclusion criteria: * significant diseases other than copd * history of asthma * copd exacerbation in previous 3 months * completion of pulmonary rehabilitation program within previous 6 weeks or current participation in pulmonary rehabilitation program. * pregnant or nursing women * patients unable to comply with pulmonary medication restrictions
clinician decision making regarding surveillance for low-risk intraductal papillary mucinous neoplasms of the pancreas

Conditions: Surgery Risk Assessment

Summary: the main objective of this study is to determine how physicians make decisions regarding surveillance of intraductal papillary mucinous neoplasm's (ipmn) of the pancreas.

the study will employ a survey design that poses physicians with a series of three clinical case vignettes. each vignette describes an ipmn of varying severity, and the physician will be asked determine whether they would continue or discontinue clinical surveillance in each case. this will be a double-blinded randomized survey study, featuring two arms. providers will be randomized to either be provided with, or not provided with a risk stratification tool (dart-1) when presented with their clinical case vignettes.

Eligibility criteria:
inclusion criteria: * membership in either the pacyfic or precede consortiums * physician with expertise in the management of ipmn * able and willing to complete survey exclusion criteria: * not a member of either the pacyfic or precede consortiums * not a physician with expertise in the management of ipmn
magnesium sulfate on postoperative pain

Conditions: Postoperative Pain

Summary: breast cancer is the most diagnosed type of cancer in women in turkey and in the world. according to the world health organization data, the rate of newly diagnosed breast cancer was reported as 11.6% in 20181. acute postoperative pain occurs in 40% of patients undergoing surgery for breast cancer2. in the early postoperative period, opioids are commonly used analgesics in the treatment of pain, but they have various side effects such as gastrointestinal, urinary and respiratory symptoms3. non-opioid analgesics can be used to reduce opioid use and thus limit its side effects. magnesium sulfate (mgso4) is an n-methyl d-aspartate (nmda) receptor antagonist that has been used for postoperative analgesia and reducing both the duration and intensity of pain by preventing central sensitization in response to peripheral painful stimulus4-9. the primary aim of this study is to investigate the postoperative analgesic efficacy of mgso4 in patients who were scheduled for mastectomy with the diagnosis of breast cancer. the secondary aim of our study is to evaluate the changes in perioperative vital signs that may occur due to mgso4.


Eligibility criteria:
inclusion criteria: 1. female breast cancer patients scheduled for mastectomy and modified radical mastectomy 2. 18≥ years and 3. patients with asa score i-ii exclusion criteria: 1. the patient who refused the study 2. drug allergy 3. unregulated diabetes mellitus and hypertension 4. cardiac failure with \<45% ejection fraction 5. renal failure (serum creatinine \> 2 mg/dl) 6. liver failure (blood transaminase values 2 fold higher than normal) 7. glaucoma 8. psychiatric or neurological disorders 9. communication difficulties with patient 10. calcium channel blockers or narcotic drugs uses before surgery
evaluation trial of handheld urinal for adult use

Conditions: Urinary Incontinence

Summary: usability and efficacy evaluation of a prototype handheld urinal for adult use

28 day usability and efficacy evaluation by 154 adults in domestic settings who suffer one or more of nocturia, urge, frequency or functional incontinence.

Eligibility criteria:
inclusion criteria: * suffers from nocturia urge, frequency, or funnctional incontinence exclusion criteria: * suffers only from stress ui
the effect of watching informative animation on fear and anxiety in children

Conditions: Inhalation Therapy; Complications

Summary: the aim of this project was to determine the effect of showing informative animations to children on anxiety and fear during inhalation therapy. this project is a randomized controlled trial. the population of the study will consist of children aged 7-12 years who apply to the pediatric emergency department of atatürk university research hospital between july 2022 and july 2023. the sample of the study will consist of children and their parents who present to the clinic on the dates determined, who are willing to participate in the study, and meet the inclusion criteria. probability sampling will be used to select the sample. ''introductory information form'', ''child fear scale'', ''facial expression rating scale'' and ''informative animation'' will be used for data collection.

type of study: the study was designed as a randomized controlled experimental study. place and time of research: the study will be conducted at atatürk university research hospital pediatric emergency department between july 2022 and july 2023. population and sample of the study: the population of the study will consist of children aged 7-12 years who apply to the pediatric emergency department of atatürk university research hospital between july 2022 and july 2023.

Eligibility criteria:
inclusion criteria: * the child is 7-12 years of age * the family's willingness to participate in the study * the child's willingness to participate in the study * the child does not have a chronic disease exclusion criteria: * the child has a chronic illness * the child has a neurological or mental impairment * the child is visually impaired
the living experience of hong kong chinese adolescents with chd.

Conditions: Congenital Heart Disease; Psychological Well-being; Quality of Life; Adolescent; Chinese

Summary: this study aims to explore the impacts of chd and its limitations on adolescents and the living experience of adolescents living with chd. hong kong chinese adolescents with chd are having reduced psychological well-being and quality of life than their healthy counterparts. qualitative study is therefore needed to explore how chd may impact on the adolescents' psychological well-being and quality of life.

a qualitative study was adopted. purposive sampling of 30 adolescents with chd were done. thematic analysis was used for data analysis. the participants unfold negative impacts of chd and its treatments, and the challenges they were facing with their relationship with others.

Eligibility criteria:
inclusion criteria: * hong kong chinese adolescents * aged 12 to 18 * able to read and write chinese * attending outpatient clinic of department of pediatric cardiology exclusion criteria: * adolescents with non-structural heart disease * with developmental delay or comorbid medical conditions

Keywords: congenital heart disease, hong kong, adolescent
correlation between exhaled propofol concentration with plasma concentration in children

Conditions: Eye Diseases

Summary: children due for elective eye surgery in propofol based anesthesia will be kept at steady state propofol infusion for maintenance, ventilation via endotracheal tube. exhaled propofol will be measured continously by edmon (r) (bbraun) monitor and compared with arterial plasma samples of propofol, drawn 3-5 times during the procedure.

the primary objective of the study is to determine the correlation between simultaneous concentrations of propofol in plasma and expiratory air in children during general anesthesia. key secondary objectives include correlating plasma and exhaled measurements of propofol with electroencephalogram (bis) values and computer estimated propofol concentrations in plasma and brain (tci: target control infusion) primary endpoint: exhaled air and plasma concentration ratios of propofol during general anesthesia in children.

Eligibility criteria:
inclusion criteria: * elective eye surgey exclusion criteria: * known propofol hypersensitivity
study of progression to progressive fibrosing interstitial lung disease (pf-ild) incidence/management and treatment

Conditions: Lung Diseases, Interstitial

Summary: the primary objective for this trial is to investigate the incidence probability of progression to progressive fibrosing interstitial lung diseases (pf-ilds) in patients with fibrosing ild other than idiopathic pulmonary fibrosis (ipf) in real-world setting in japan. the secondary objective is to investigate the characteristics of procedures for management and treatment in patients with fibrosing ild other than ipf in real-world setting in japan.


Eligibility criteria:
inclusion criteria: 1. patients diagnosed with at least two fibrosing interstitial lung disease (ild) codes on different dates in the patient identification period 2. patients aged 18 years and older on the index date 3. patients for whom data for the 12 months prior to the index date can be extracted as baseline data exclusion criteria: 1. patients grouped into the underlying disease of idiopathic pulmonary fibrosis (ipf) 2. patients who have met pf-ild progression criteria during the baseline period
a long term follow-up study of subjects who received icm-203 or matching placebo

Conditions: Osteoarthritis, Knee

Summary: this is an observational study of the long term safety and efficacy of icm-203.

subjects who have received icm-203 or matching placebo from icm-203 clinical studies will be enrolled. subjects will be contacted annually to collect safety and efficacy outcomes until 5 years after the last dose of icm-203 or placebo.

Eligibility criteria:
inclusion criteria: * previous receipt of icm-203 or matching placebo exclusion criteria: * none

Keywords: adeno-associated virus gene therapy icm-203 osteoarthritis
using high resolution function imaging to detect melanoma and dysplastic nevi

Conditions: Melanoma

Summary: a novel infrared imaging tool to aid in the clinical detection of atypical pigmented lesions and melanoma is developed. goals include evaluation of the utility of high-resolution infrared scanning of cutaneous lesions in the diagnosis of pigmented lesions and the identification of high-risk lesions and melanomas.

this study uses a specific skin protocol to cool the skin and then measures the cutaneous thermal recovery to uniquely identify lesions that may be cancerous. using computer models, the thermal signature is used to determine the size and shape of the lesions in question. in particular, this study seeks to add quantification analysis of high resolution thermal images of melanoma lesions to provide accurate early diagnostic capability with specific detail regarding size, shape and depth of the lesions. this information will be compared to biopsy results and surgical resection results.

Eligibility criteria:
inclusion criteria: * patients seen in the high-risk pigmented lesion clinic, who posses a pigmented lesion with a clinical indication for biopsy exclusion criteria: * none

Keywords: thermography
preliminary safety and efficacy of the pds-1.0 in patients with neovascular age related macular degeneration (amd)

Conditions: Age-Related Macular Degeneration

Summary: this study will evaluate the preliminary safety and efficacy of pds 1.0 in patients with neovascular amd.


Eligibility criteria:
inclusion criteria: * diagnosis of cnv secondary to amd confirmed by fluorescein angiography, not previously treated * retinal thickness due to edema of at least 300um in the study eye * best corrected visual acuity of 20/40 or worse in the study eye * best corrected visual acuity of 20/40 or better in the fellow eye exclusion criteria: * evidence of scarring cnv (e.g. geographic atrophy) in the study eye * fibrosis \>75% of lesion area in the study eye
functional imaging and reading deficit in children with nf1

Conditions: Neurofibromatosis Type 1

Summary: a monocenter pilot study on the acceptability and feasibility of a functional mri protocol in children with nf1 with or without reading disabilities.

the principal aim of the study is to highlight the activation of brain area involved phonological and visuo-spatial processing in children with nf1 with or without reading disabilities.

Eligibility criteria:
inclusion criteria: * age included between 8 and 12 years * child presenting a type 1 neurofibromatosis according to 2 criteria in the following criteria list : * at least 6 café au lait spots * 2 or more neurofibromas or 1 plexiform neurofibroma * axillary or inguinal freckling * 1 optic nerf glioma * 2 or more lisch nodules * 1 osseous lesion as sphenoid dysplasia or thinning of the long bone cortex with or without pseudarthrosis * 1 a first degree relative (parent, sibling, or offspring) with nf1 by the above criteria * membership in a national insurance * consent of the child and the parents exclusion criteria: * mental retardation (qi t \< 70) * treated or untreated epilepsy * visual deficit (visual acuteness \< 4/10 * presence of a symptomatic optic glioma * presence of a brain tumor.

Keywords: nf1 children reading disability morphological and functional mri genetic analysis
specific manual approach to the suboccipital area on patients with chronic mechanical neck pain

Conditions: Neck Pain

Summary: there are different inhibition suboccipital techniques, usually adjuvant of physiotherapy, for treatment of patients with chronic neck pain. in our clinical practice, a favorable effect is observed on patients with chronic neck pain, but there are no published studies evaluating the results of this techniques on pain, mobility and disability. the objective of this trial is to evaluate if the suboccipital manual techniques, provides further improvement in pain intensity, neck disability, range of motion, on patients with chronic mechanical neck pain and rotation deficit of the upper cervical spine, being treated with physiotherapy. for this purpose, investigators conduct a double-blind (patient and evaluator) randomized controlled trial, in a public primary care center. seventy four subjects will be randomized (computer application) into three groups: mobilization group, maintained pressure group and control group. all the three groups receive the same protocolized physiotherapeutic treatment during three weeks and, additionally, the mobilization group receives six sessions (two sessions in a week during three weeks) of translational dorsal glide mobilization technique grade iii of the atlanto-occipital joint and the maintained pressure group receives six sessions (two sessions in a week during three weeks) of pressure maintained suboccipital inhibition technique. the control group receives the protocolized physiotherapeutic treatment only. pain intensity (vas), neck disability index (ndi), range of motion (crom), will be measured at baseline, after treatment period, and three months after discharge from treatment. after discharge for treatment the patient subjective opinion about their evolution will be collected through a global rating of change (groc) scale, and evaluation of headache disability (hit-6).


Eligibility criteria:
inclusion criteria: * diagnosis of chronic mechanical neck pain. * flexion-rotation test positive (less of 32 degrees or 10 degrees difference between the two sides) * sign the informed consent form. exclusion criteria: * presenting one or more positive safety cervical test . * carriers of pacemaker or defibrillators. * previous history of severe trauma to the cervical region of the spine. * inflammatory arthritis. * inability to maintain supine position. * inability to tolerate flexion-rotation test * poor language and communication skills making difficult to understand the informed consent. * pending litigation or legal claim.

Keywords: physiotherapy manual therapy neck pain