Kornimate/medical-research-clean huggingface dataset:
medical supervised duodenal-enteral feeding treatment

Conditions: Obesity; Obesity, Visceral; Overweight and Obesity; Body Fat Disorder; Feeding and Eating Disorders; Hormone Disturbance; Weight Loss

Summary: medical supervised duodenal-enteral feeding for overweight, obesity and increased body fat percentage treatment based on an intervention procedure performed by a licensed nutritionist doctor for weight loss and loss of fat percentage in patients who need it.

medical supervised duodenal-enteral feeding for overweight, obesity and increased body fat percentage treatment based on an intervention procedure performed by a licensed nutritionist doctor for weight loss and loss of fat percentage in patients who need it. the feeding is by nasogastric-duodenal tube depending on the desired fat loss and / or weight in relation to the basal metabolism. feeding by tube of 12-29 days, continuing with personalized nutritional treatment for 2 weeks and physical activity during the protocol. losses of weight and / or expected fat greater than 10%. the results will be compared with bariatric surgery. the main objective is to provide a tool for the obesity epidemic that can be applied worldwide by doctors without the complications of surgery and with a lower price for health systems and controlling the actions of the hormones leptin and ghrelin.

Eligibility criteria:
inclusion criteria: - desire for weight loss, desire to improve body image, voluntariness exclusion criteria: - esophageal alteration or swallowing, not sign the informed consent, acute active disease

Keywords: obesity overweight fat percentage body fat enteral feeding fat loss
gut permeability, sensitivity and symptomatology

Conditions: Irritable Bowel Syndrome; Visceral Hypersensitivity

Summary: to better understand the relationship between gut barrier function and the symptomatology and pathophysiology of irritable bowel syndrome (ibs).


Eligibility criteria:
inclusion criteria * age 18 to 70 years * no abdominal surgery (except appendectomy, cholecystectomy, hernia repair, hysterectomy, and c-section). * written informed consent exclusion criteria * females who are pregnant or breastfeeding * use of tobacco products within the past 6 months (since nicotine may affect intestinal permeability) * use of nsaids or aspirin within the past week (since nsaids affect intestinal permeability) * use of oral corticosteroids within the previous 6 weeks * ingestion of artificial sweeteners such as splenda (sucralose), nutrasweet (aspartame), lactulose or mannitol 2 days before the study tests begins, e.g. foods to be avoided are sugarless gyms or mints and diet soda. * ingestion of any prescription, over the counter, or herbal medications which can affect gastrointestinal transit 7 days before the study begins. * proton pump inhibitors. * antibiotics for the preceding 60 days before the start of the study. * (vii) alcohol intake beyond the recommended safe limit (\<21 unites per week) * bleeding disorders or medications that increase risk of bleeding from mucosal biopsies. * known allergy to fluorescein * inflammatory bowel diseases, celiac disease.

Keywords: ibs irritable bowel syndrome visceral hypersensitivity permeability small bowel lactulose mannitol
examination of the applicability and performance of otolaryngology telemedicine, telediagnostics in establishing the diagnosis and therapy of otolaryngology diseases

Conditions: Ear Infection; Telemedicine

Summary: system/device name: otoscopic recording and clinical data telemedicine software supporting its transmission and analysis. characteristics of the medical device: the device is applied to an iphone with a ce mark also from a ce-marked optical unit and the system operator, a consists of software under investigation.

the detailed operation is in the user guide in hungarian included. the device makes a video recording of the external ear canal and about the tympanic membrane, and it records clinical data (symptoms, complaints). the telephone application sends the data through the system to a doctor, who, by analyzing them, makes a diagnosis and provides therapy. the study is a prospective, single-arm study. the specialist treating the real patient (called doctor 2) does not see or know the diagnosis and the therapy from the telemedicine system, or the recommendation from the telemedicine the diagnosis and therapeutic treatment established by the two methods are evaluated by an independent specialist and decides whether the primary diagnosis and therapeutic treatment are the same or not in the telemedicine system.

Eligibility criteria:
inclusion criteria: * signed informed consent form * patients with ear complaints (especially, but not exclusively, ear pain from the ear discharge, itching, cerumen accumulation,) * the subject communicates well with the investigator and is able to understand the requirements of the test plan and to help with compliance. exclusion criteria: * poor general condition * based on the investigator's decision, a condition that directly threatens life or a symptom that corresponds to these may indicate (e.g.: liquor dripping, massive bleeding, etc.) * any disease that, in the investigator's opinion, endangers the patient's health and/or contraindicates performing the test * the examiner finds that further participation is a disadvantage for the patient for any reason; * the patient requests the suspension of his participation orally or in writing
study to evaluate the reactogenicity and safety of rotarix™ in chinese adults

Conditions: Infections, Rotavirus

Summary: the purpose of this study is to assess the safety of rotarix ™ when administered in healthy adults aged 18 to 45 years in china.


Eligibility criteria:
inclusion criteria: * subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study. * a male or female subject of chinese origin, 18 years to 45 years inclusive of age at the time of the vaccination. * written informed consent obtained from the subject. * healthy subjects as established by medical history and clinical examination before entering into the study. * female subjects of non-childbearing potential may be enrolled in the study. * female subjects of childbearing potential may be enrolled in the study, if the subject: * has practiced adequate contraception for 30 days prior to vaccination, and * has a negative pregnancy test on the day of vaccination, and * has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of vaccination. exclusion criteria: * use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the dose of study vaccine, or planned use during the study period. * acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by medical history, physical examination or laboratory tests. * any clinically significant history of chronic gastrointestinal disease including uncorrected congenital malformation of gastrointestinal tract that would predispose for intusussception. * gastroenteritis within 7 days preceding the study vaccine or placebo administration. * any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. * history of allergic disease or reactions likely to be exacerbated by any component of the vaccine. * chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to vaccination. planned administration/ administration of a vaccine not foreseen by the study protocol within 14 days of the study vaccine or placebo and ending 14 days after. * concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product * administration of immunoglobulins and/ or any blood products within the three months preceding the dose of study vaccine or planned administration during the study period. * acute disease at the time of enrolment. * pregnant or lactating female. * female planning to become pregnant or planning to discontinue contraceptive precautions. * history of chronic alcohol consumption and/ or drug abuse.

Keywords: human rotavirus vaccine
comparative efficacy of 20% benzocaine versus tac alternate gel

Conditions: Dental Pain; Postoperative Pain

Summary: the project is a study comparing the effectiveness of two topical anesthetics for control of pain associated with dental needle insertion in the palatal mucosa. a standard dental topical anesthetic (20% benzocaine) will serve as an "active" control and will be compared to a combination topical anesthetic, consisting of 20% lidocaine, 4% tetracaine and 2% phenylephrine (tac alternate gel, compounding arts pharmacy, lafayette, la).


Eligibility criteria:
inclusion criteria: 1. volunteers 18 years or older 2. ability to consent to participate in the research 3. ability to communicate a vas score 4. generally healthy, asa i and asa ii 5. no known drug allergies 6. ability to tolerate pulse oximeter and blood pressure cuff without psychological, or physiological consequence exclusion criteria: 1. allergy or other contraindications to the topical anesthetics 2. inability to consent to participation in the study 3. use of analgesics prior to the procedure 4. vulnerable populations

Keywords: topical anesthetics topical anesthesia 20% benzocaine tac alternate gel combination topical anesthetics dental anesthesia
prospective validation of clinical prediction model for venous thromboembolism following neurosurgery

Conditions: Venous Thromboembolism; Neurosurgery; Risk Assessment

Summary: validation of clinical prediction model for venous thromboembolism following neurosurgery: a multicenter, prospective, and cohort study

a clinical prediction model for vte after neurosurgical procedures during hospitalization has been developed and internally retrospectively validated. a multicenter, prospective cohort study is planned to validate this clinical prediction model again.

Eligibility criteria:
inclusion criteria: 1. age \>18 years 2. underwent neurosurgical procedures during hospitalization 3. underwent preoperative ultrasound examination exclusion criteria: 1. a patient with obvious bacterial or viral infection within the past two weeks before admission 2. a patient with venous thromboembolism within the past three months before surgery 3. a patient with anticoagulant therapy (direct oral anticoagulants, low molecular weight heparin) was administered continuously or intermittently before admission 4. a patient with a prior coagulation dysfunction
dnase treatment for dry eyes

Conditions: Dry Eye

Summary: the purpose of this study is to evaluate the tolerability and preliminary efficacy of dnase eye drops in patients with sjogren's and non-sjogren dry eye disease.


Eligibility criteria:
inclusion criteria: * aged 18 years or older. * capable of giving informed consent and does provide informed consent. * documented dry eye disease for at least 6 months. * schirmer i \<10 * corneal/ conjunctival (rose bengal) staining ≥1 * ocular symptoms must be considered as annoying or activity limiting (osdi ≥13; mild). * women must be post-menopausal ≥ 1 year, or surgically sterilized. if not, a negative urine pregnancy test is required within 14 days of receiving her first dose of test medication (placebo/ study drug) along with definite evidence of contraceptive use during the duration of the study. exclusion criteria: * allergic to deoxyribonuclease eye drops or any similar products, or excipients of deoxyribonuclease eye drops 0.1%. * receiving or have received within 30 days any experimental systemic medication. * active ocular infection or ocular allergies. * any history of eyelid surgery or ocular surgery within the past 3 months. * corneal epithelial defect larger than 1 mm2 in either eye. * the use of topical cyclosporine or corticosteroids within 2 weeks of enrollment * have active drug/alcohol dependence or abuse history

Keywords: dnase, pulmozyme, dry eye disease, treatment
development and validation of intraoperative image-quality criteria

Conditions: Proximal Femur Fractures

Summary: an expert panel of surgeons agreed that there is not any established, standardized approach to the teaching of intraoperative imaging and that there may be practice gaps in decision making and the use of imaging among trauma surgeons. the panel is set to initiate a consensus-based evaluation process to develop a list of criteria for assessing images and would like to validate these criteria for differentiating good quality versus poor quality images in term of reliability and accuracy.


Eligibility criteria:
inclusion criteria: * diagnosis of proximal femur fracture * operated between may 2010 and december 2010 * open reduction internal fixation (orif) * lateral and anteroposterior intraoperative images available exclusion criteria: none

Keywords: radiographic image enhancement, intraoperative care femoral fractures femoral neck fractures hip fractures, internal fixators fracture fixation internal fracture fixation intramedullary fractures bone
the study observes how long patients with non-small cell lung cancer (nsclc) benefit from treatment with epidermal growth factor tyrosine kinase inhibitor (egfr-tki) when given either for uncommon mutations or for common mutations in the sequence afatinib followed by osimertinib

Conditions: Non-squamous, Non-Small Cell Lung Cancer

Summary: non-interventional, multi-country, multi-centre cohort study based on existing data from medical records (paper or electronic) or electronic health records of patients with advanced nsclc harbouring egfr mutations and treated with an egfr-tki


Eligibility criteria:
inclusion criteria: 1. adult patients 2. diagnosed with epidermal growth factor receptor tyrosine kinase inhibitor (egfrtki) naive advanced egfr mutated non-small cell lung cancer (nsclc), 3. treated for epidermal growth factor receptor (egfr) mutated nsclc within regular clinical practice. 4. informed and privacy consent signature must be obtained depending on local regulations. more specific inclusion criteria for each cohort are the following: uncommon mutation cohort: 5. patients harbouring uncommon or compound egfr mutations 6. patients who started with either afatinib (gi(l)otrif®), gefitinib (iressa®), erlotinib (tarceva®), or osimertinib (tagrisso®) in the first- or second-line setting within regular clinical practice 7. patients must have started egfr-tki treatment at least 12 months prior to data entry. sequencing cohort: 5. patients with common egfr mutations (del19, l858r) 6. patients were treated with afatinib (gi(l)otrif®) in the first-line setting and for acquired t790m mutation with osimertinib in the second line; 7. patients must have started osimertinib treatment at least 10 months prior to data entry. patients treated with osimertinib within an early access program/ compassionate use program (eap/cup) are allowed exclusion criteria: 1. patients treated for egfr mutated nsclc within a clinical trial or participated in giotag study. 2. patients with active brain metastases at start of egfr-tki therapy (independent of treatment line) 3. for uncommon mutation cohort: patients treated with osimertinib with no further uncommon mutation than acquired t790m further exclusion criteria apply
investigation of gene mutations in patients with triple-negative and patients with her2+ breast cancer adenocarcinoma

Conditions: Breast Cancer

Summary: the present study is a transnational study in patients with high risk recurrent breast cancer who receive adjuvant chemotherapy with epirubicin and cyclophosphamide followed by docetaxel or paclitaxel.

this will be a retrospective analysis of patients with histologically confirmed triple-negative or her2+ operable breast cancer (with high risk of recurrence) who are treated at hellenic cooperative oncology group (hecog)- affiliated departments of oncology. patients who participate are 18 years or older, women of any menopausal status with triple-negative or her2+ breast cancer who receive epirubicin and cyclophosphamide every two weeks followed by docetaxel every three weeks or weekly paclitaxel. patients with her2-positive tumors are treated with trastuzumab, initiated concurrently with the first cycle of docetaxel, for 52 weeks. pertuzumab may be combined with trastuzumab only in patients with node-positive disease.patients can be treated with hormone therapy and/or radiotherapy. the investigation of the potential biomarkers will be performed using in situ methods in formalin fixed paraffin embedded (ffpe) tumor sections. more specific will be investigated the expression of estrogen and progesterone receptors, the expression of sparc proteins, special cellular activation and metastasis systems and other important pathways in cell life and reproduction. statistical analysis: the primary endpoint of the study will be the progression-free survival (pfs), defined as the time from treatment initiation to either the first documented disease progression or death from any cause. second primary endpoint will be the overall survival (os), defined as the time from treatment initiation to patient's death or last contact. survival curves will be estimated using the kaplan-meier method and compared across groups with the log-rank test. the associations between the clinicopathological factors to be examined and the mortality rate will be evaluated with hazard ratios estimated with cox proportional hazards model. the statistical analyses will be completed using the sas software (sas for windows, version 9.3, sas institute inc., cary, nc).

Eligibility criteria:
inclusion criteria: * 18 years or older * αny menopausal status is allowed * triple-negative breast cancer * her2+ breast adenocarcinoma * tumor size \<= 5 cm * presence of operable axillary lymph nodes or the presence of clinicopathological parameters indicating an intermediate or high risk of recurrence without the presence of infiltrated lymph nodes * performance status (ps) = 0 or 1 * adequate bone marrow function , heart, liver and kidney * no other history of previous neoplasm or other serious illness exclusion criteria: -

Keywords: triple-negative breast cancer her2 positive breast adenocarcinoma
tissue collection for biomarkers determining resistance to ibrutinib

Conditions: Mantle Cell Lymphoma; Chronic Lymphocytic Leukaemia

Summary: clinical validation of biomarkers determining resistance to btk inhibition with ibrutinib in mantle cell lymphoma and chronic lymphocytic leukaemia stage 1.

with the recent fda approval of ibrutinib for the management of relapsed/refractory mcl and cll, we are entering an exciting phase in the management of these conditions. a crucial next step is to validate biomarkers that predict clinical activity of ibrutinib in order to tailor therapy and maximise benefit to patients. the recently opened named patient supply (nps) of ibrutinib in the uk provides an excellent window of opportunity for these studies. the investigators have set up a collaboration with professor simon rule (plymouth) and dr george follows (cambridge), who are carrying out a prospective data collection study for patients entered on to the nps. with the help of our collaborators the investigators will be able to identify centres in the nhs for collection of samples. patients entered on to the nps will be provided an information sheet and research specific consent form following which samples from consenting patients will be transferred to the royal marsden hospital (rmh) for storage. samples will be logged and tracked using a secure database. samples for research will be collected at the same time as routine sampling and therefore no additional sampling will be required. for each patient, consent will be obtained for pretreatment, progression as well as any diagnostic samples taken or stored and patients will require to be on the study for at least 24 months from the start of their treatment. the collection will end 24 months after the last patient commences treatment on the nps. once we have an idea of the number of patient samples we can collect, the second stage of this study will be initiated and will involve molecular screening of samples at rmh for biomarkers of resistance. the data from the molecular studies will then be correlated with the clinical response data from our collaborators for clinical validation.

Eligibility criteria:
inclusion criteria: * all patients entered into the ibrutinib nps for relapsed refractory mcl and cll in the uk and who consent to have biological material stored for this research will be included in the study. patients who have already commenced treatment with ibrutinib will also be eligible whether or not they are responding. exclusion criteria: * all samples received will undergo histological (or morphological) review and immunophenotyping. the following samples will be excluded- 1. samples not satisfying the criteria for diagnosis of cll or mcl. 2. samples with evidence of high grade transformation (e.g. richter's transformation of cll).
preservation of blood in extremely preterm infants

Conditions: Bronchopulmonary Dysplasia

Summary: current clinical protocols for blood sampling and analyses in extremely preterm infants rely on an infrastructure adapted to and developed for adult medicine. excessive blood sampling volumes and the resulting loss of fetal blood components are related to neonatal morbidity. this randomised trial aims to provide evidence that preservation of blood using micro-methods results in decreased morbidity and increased quality of life in extremely preterm infants.

extremely preterm (ept) infants are subjected to a sample-related withdrawal of whole blood of 50 % of total blood volume during the first 2 postnatal weeks and a transfused volume of 100 % of total blood volume with donor blood during the corresponding time period. the resulting decrease in the proportion of fetal hemoglobin is strongly associated with morbidity outcome, especially broncho-pulmonary dysplasia (bpd), in the ept infant. this randomized trial evaluates if a reduction in sample-related blood volume loss by 50% during the first two postnatal weeks leads to a reduced rate of bpd in ept infants. half of the included infants will be subjected to clinical blood sampling using micromethods during the first two postnatal weeks whereas blood sampling in the other half of infants will be performed using standard clinical methods.

Eligibility criteria:
inclusion criteria: * gestational age \< 27 weeks at birth exclusion criteria: * major malformation

Keywords: extremely preterm infant blood sampling blood transfusion
comparison of image quality between "double low dose" liver ct and standard liver ct

Conditions: Metastasis to Liver; Colorectal Cancer

Summary: in patients with malignancies, contrast-enhanced abdominal ct (hereafter abdominal ct) plays an important role in detecting carcinoma recurrence and assessing treatment response. in this study, we aim to investigate whether such a "double low" dose ct is feasible in patients with liver metastases of colorectal cancer using a vendor-agnostic artificial intelligence-based noise reduction and contrast enhancement software.


Eligibility criteria:
inclusion criteria: * colorectal cancer (crc) patients * on surveillance or monitoring for liver metastasis (of crc) exclusion criteria: * any relative or absolute contra-indication of cect * diffuse infiltrative type of liver metastasis or on monitoring for too many liver lesions

Keywords: ct