Kornimate/medical-research-clean huggingface dataset:
helicobacter pylori, atrophic gastritis and intestinal metaplasia registry and prospective study

Conditions: Helicobacter Pylori; Atrophic Gastritis; Intestinal Metaplasia

Summary: since much is unknown about factors that lead to progression of the pre-neoplastic lesions and cancer. in addition, there is ongoing debate on the optimal surveillance intervals and techniques. to solve these important clinical questions, the establishment of a registry for a longitudinal study is planned.

helicobacter pylori is believed to affect more than half of the world's population and is thought to affect nearly 2 million people in hong kong alone. it is a major cause of peptic ulcer disease and is implicated in the pathogenesis of the majority of gastric cancers. since 1994, the world health organization has designated h. pylori infection as a class 1 carcinogen. gastric cancer was the sixth commonest malignancy in hong kong in 2015; it was also the second commonest cause of death from cancer in asia. it is thought that chronic inflammation of the gastric mucosa caused by h. pylori progresses to pre-neoplastic lesions, namely atrophic gastritis and intestinal metaplasia, before developing into frank dysplasia and carcinoma. successful h. pylori eradication can lead to a rapid decrease in active inflammation, with early treatment effective in preventing the progression of disease. it is believed that atrophic gastritis may be reversible, whereas intestinal metaplasia has passed the point of no return and unlikely to have regression. national screening programmes in both japan and korea recommend endoscopy for all men and women over 40 years of age with several uncontrolled trials suggesting that this has led to a reduction of mortality due to gastric cancer. however, in countries with a lower incidence of gastric cancer, this population-based approach may not be cost-effective. much is unknown about factors that lead to progression of the pre-neoplastic lesions and cancer. in addition, there is ongoing debate on the optimal surveillance intervals and techniques. to solve these important clinical questions, the establishment of a registry for a longitudinal study is planned.

Eligibility criteria:
inclusion criteria: * adults \>= 18 years of age * written informed consent obtained * diagnosed with current or past h. pylori infection, * histologically proven atrophic gastritis (body and/or antrum of stomach), intestinal metaplasia (complete and incomplete), dysplasia (any grade) and/or gastric cancer (post- treatment) exclusion criteria: * co-morbid illness that prohibit endoscopic surveillance * declines for study questionnaire, biobanking of specimens and/or regular review per study protocol
a dose-finding phase iib study with azd0865 and esomeprazole in gerd patients with erosive esophagitis.

Conditions: GERD With Erosive Esophagitis

Summary: the primary objective is to compare the efficacy between three doses of azd0865 (25, 50 and 75 mg). the secondary objectives are to compare the efficacy between the three doses of azd0865 and esomeprazole 40 mg and to evaluate the safety and tolerability of azd0865.


Eligibility criteria:
inclusion criteria: * identification of their main symptom as heartburn defined as a burning feeling behind the breastbone. * have at least a 6-month history of heartburn and at least 4 days of episodes of heartburn with at least overall moderate intensity during the last 7 days prior to visit 1. * erosive esophagitis according to la classification grade a, b, c or d, at the visit 1 endoscopy. * have provided informed consent. exclusion criteria: subjects with current or historical evidence of the following conditions are excluded from the study: * esophageal stricture. * primary esophageal motility disorder(s), i.e. diffuse esophageal spasm, achalasia. * systemic sclerosis (scleroderma). * irritable bowel syndrome (ibs), i.e. upper abdominal discomfort or pain that in the opinion of the investigator is likely to be due to ibs or fulfilling two or more of the criteria: relieved by defecation, associated with change in frequency of stools, associated with change in form (appearance) of stools. * inflammatory bowel disease. * zollinger-ellison syndrome. * gastric ulcer, duodenal ulcer or duodenal erosions within the last 3 months subjects with i) history of significant or ii) current significant or unstable: * cardiovascular diseases or cardiac chest pain. * cerebrovascular diseases, such as cerebral ischemia, infarction, haemorrhage, or embolus. * diabetes mellitus. stable diabetes controlled on diet, oral agents or insulin is acceptable. * pulmonary, renal, pancreatic or liver diseases or any other serious disease as judged by the investigator to interfere with the evaluation of the current study. * malignant disease (except for minor superficial skin disease). * generalised bleeding disorders.

Keywords: gerd with erosive esophagitis
care transition intervention for hospitalized patients with advanced cancer

Conditions: Cancer; Follow-Up Care; Consultation, Remote; Advanced Cancer

Summary: this study is examining whether a care transition intervention, continuum (continuity of care under management by video visits), consisting of a supportive care-focused video visit with an oncology nurse practitioner (np) within three business days of hospital discharge, may improve post-discharge transitions of care for recently hospitalized patients with advanced cancer.

to address the rising incidence and burden of hospital readmissions for patients with advanced cancer, the investigators developed a population-specific care transition intervention based upon the scholarly literature and our qualitative study. the intervention, continuum (continuity of care under management by video visits), consists of a video visit conducted by an oncology np within three business days of hospital discharge, to: (1) reconcile medications, (2) manage symptoms, (3) review the post-hospital care plan for hospitalization-specific issues, and (4) schedule follow-up with the outpatient oncology team. from 01/07/21 to 05/28/21, the investigators conducted a pilot trial of continuum in 48 patients with advanced cancer recently discharged from the massachusetts general hospital cancer center (nct04640714). the investigators found that the intervention was feasible and acceptable in our population. the investigators are now conducting a randomized controlled trial of the continuum intervention versus standard of care, to study whether continuum improves patients' confidence in managing their health condition, as measured by the patient activation measure-13. the investigators will also assess the efficacy of continuum for improving patient satisfaction with clinician communication, and physical and psychological symptom burden. lastly, the investigators will explore the effect of the intervention on hospital readmissions within 30-days. study procedures include random assignment to either the continuum intervention or standard oncology care following hospital discharge, questionnaires and medical record data collection. participants are expected to be on the study for up to 40 days after hospital discharge. it is anticipated that about 286 people will take part in this research study.

Eligibility criteria:
inclusion criteria: * age \>= 18 years * first unplanned admission to the oncology service at massachusetts general hospital (mgh) since diagnosis of advanced cancer * known diagnosis of advanced breast, thoracic, genitourinary, or gastrointestinal cancer * receiving ongoing oncology care at mgh * verbal fluency in english * internet/wifi or telephone access * residing in massachusetts at the time of hospital discharge exclusion criteria: * admitted electively * discharged to a location other than home or expired during admission * discharged with hospice services

Keywords: cancer follow-up care care services, home consultation, remote advanced cancer hospitalization care transition intervention
individual cerebral hemodynamic oxygenation relationships (ichor 1)

Conditions: HIE; TBI (Traumatic Brain Injury); TBI; Hemodynamic Instability; Hypoxic-Ischemic Encephalopathy

Summary: this is an observational study in patients who require clinical anesthesia. the main purpose of this study is to understand whether there are differences in the cerebral blood flow, and oxygen metabolism affected by different types of anesthesia. subjects who require clinical anesthesia for a clinical mri and for whom the use of anesthetics for the exam are in clinical equipoise are asked to join the study. all eligible subjects will be asked to provide informed consent before participating in the study.

this is an observational study in patients who require clinical anesthesia. the main purpose of this study is to understand whether there are differences in the cerebral blood flow, and oxygen metabolism affected by different types of anesthesia. subjects who require clinical anesthesia for a clinical mri and for whom the use of anesthetics for the exam are in clinical equipoise are asked to join the study. all eligible subjects will be asked to provide informed consent before participating in the study. treatment: those who meet eligibility criteria, and who undergo the informed consent, will have their mri extended by up to 7.5 minutes for up to 5 times. standard-of-care anesthesia safety, dose and monitoring will not be changed. during their mri, the additional images acquired will teach us about cerebral blood flow and cerebral venous oxygenation. participants will also have non-invasive monitoring of their hematocrit immediately following the exam. safety assessment: the experiment will occur in the standard-of-care clinical mri environment. all patient safety and monitoring will remain in place. throughout the induction, maintenance and recovery from anesthesia, all procedures will occur in the standard of care environment and will be overseen by trained clinical personnel. efficacy assessment: structural, and/or cerebral blood flow and/or metabolism mris will be collected from all subjects.

Eligibility criteria:
inclusion criteria: * individuals who are able to tolerate an mri. * are patients scheduled for a clinically indicated mri. * between birth and up to 18 years. exclusion criteria: * presence of an mri-incompatible device or implant (e.g. pacemakers, stents) * unable to tolerate the enclosed spaces and loud noises for the duration of time in scanner required to obtain an mri. * preterm infants less than 25 weeks * any patient who is clinically too unstable to extend their mri by up-to 7.5 minutes.
efficacy and safety study of pegasys in the treatment of chronic hepatitis b

Conditions: Chronic Hepatitis B

Summary: the purpose of this study is to determine the safety and efficacy of pegasys + placebo + lamivudine versus lamivudine alone in patients with lamivudine versus lamivudine alone in patients with hepatitis b antigen chb.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of hepatitis b * not pregnant exclusion criteria: * treatment for hepatitis b in past 6 months * other hepatitis infections * severe liver disease * pregnancy
bilateral ultrasound-guided erector spinae plane block for postoperative analgesia in breast reduction surgery

Conditions: Postoperative Pain; Breast Hypertrophy

Summary: erector spinae plane (esp) block is a novel block developed by forero to treat severe neuropathic pain and was firstly reported in 2016. anatomical and radiological investigations in fresh cadavers indicate that its site of action is likely at the dorsal and ventral rami of the thoracic spinal nerves. the esp block has a clear and simple sonoanatomy, it is easy to perform, not time consuming and generally well tolerated by the patients. so, the investigators believed that the esp block may be an effective and safer alternative to paravertebral block, epidural analgesia and other myofascial thoracic wall blocks in breast surgery and designed a prospective, randomised, placebo-controlled trial for pain management.


Eligibility criteria:
inclusion criteria: * american society of anesthesiologists (asa) i-ii, 18-65 years of age, adult, female patients undergoing elective breast reduction surgery exclusion criteria: * coagulopathy * allergy to amide-type local anesthetics * infection at the esp block injection site * severe obesity (bmi \> 35 kg/m2) * liver or renal deficiency * patients with anatomical deformities * recent use of analgesic drugs * patient refusal or inability to consent
tr64 in patients with advanced solid tumors

Conditions: Advanced Solid Tumor

Summary: this is a open-label, dose escalation, accelerated titration combined 3+3 design, phase i study, to evaluate the safety and tolerability, and to determine the rp2d of tr64 when administered qd in patients with advanced solid tumors. up to 6 cohorts of 1-6 or 3-6 patients each will be treated in the study.

patients will receive study treatment until criteria for study termination are met. a safety follow-up visit will be conducted 28 days (±7 days) after the last dose of study treatment. patients who discontinue study treatment for reasons other disease progression will have post-treatment follow-up for disease assessment until start of new anticancer treatment, patient withdraws consent, is lost to follow-up, death, or until the sponsor stops the study, whichever comes first. adverse events will be assessed using the nci common terminology criteria for adverse events (nci-ctcae) version 5.0. tumor response will be assessed by computed tomography (ct) and/or magnetic resonance imaging (mri) scan using recist 1.1 criteria, assessed by the investigator.

Eligibility criteria:
inclusion criteria: * fully understand the procedures of the clinical study and participate voluntarily with signed and dated written informed consent form, comply with the requirements of the study protocol. * males and/or females at least 18 years old when signing the informed consent form. * histologically or cytologically confirmed patients with advanced malignant solid tumors, eligible patients must have failed standard treatment, no standard treatment, or not suitable for standard treatment at this stage as determined by the investigator. * measurable disease with at least one lesion amenable to response assessment per recist 1.1. * eastern cooperative oncology group performance status (ecog) ≤2 at screening. * life expectancy of at least 3 months. * acceptable organ function: absolute neutrophil count(anc)≥1.5×109/l; platelet count(plt)≥90×109/l; hemoglobin(hb)≥90 g/l; total bilirubin(tbil)≤1.5×upper limit of normal value(uln); alanine aminotransferase(alt)≤2.5×uln; aspartate aminotransferase(ast)≤2.5×uln; creatinine clearance ≥50ml/min. * fertile male and female must agree to use medically approved contraceptives during the study and within 90 days after the last dose of the study. exclusion criteria: * known or suspected allergies to any of the investigational drug composition. * medical history and surgical history excluded according to the protocol. * any previous medical treatment history exclude from the protocol. * abnormal laboratory results exclude from the protocol. * pregnant and lactating women (currently breast-feeding or less than six months after delivery although not breast-feeding). * subjects may not be able to complete the study duo to poor compliance or other reasons, or unsuitable for the study by the investigator's judgment.
anti cancer stem cell activity of pre-operative bevacizumab and chemotherapy in breast cancer

Conditions: Breast Cancer

Summary: the purpose of this study is to evaluate anti-cancer stem cell (csc) activity (measured by the amount of aldehyde dehydrogenase 1/aldh1+ cells before and after treatment) of pre-operative bevacizumab in combination with conventional chemotherapy in breast cancer receiving neo-adjuvant treatment, compared to a control arm receiving chemotherapy alone.


Eligibility criteria:
inclusion criteria: * women older than 18 ys * primary breast cancer treated in the neoadjuvant setting (synchronous metastatic disease are eligible) * primary breast tumor accessible to initial biopsy * white blood count \> 3.000/µl and absolute neutrophil count ≥ 1.500/µl and platelets ≥ 100 x 109/l and hemoglobin ≥ 9 g/dl, serum creatinine ≤ 150µm/l• urine dipstick for proteinuria \< 2+. patients discovered to have ≥ 2+ proteinuria on dipstick urinalysis at baseline should undergo a 24 hour urine collection and must demonstrate ≤ 1 g of protein in 24 hours, total bilirubin ≤ 1.5 uln and asat \< 2.5 uln and alat \< 1.5 uln (2.5 if liver metastasis), adequate coagulation function: international normalized ratio (inr) ≤ 1.5 and tca ≤ 1.5 x uln * left ventricular ejection fraction (lvef) ≥ 55% (isotopic or * ultrasound methods) * karnofsky index \> 1 ; performance status 0 to 1 * patients must have signed a written informed consent form prior to any study specific screening procedures * patient affiliated to the national "social security" regimen or beneficiary of this regimen. exclusion criteria: * previous history of cancer (other than curatively treated basal and squamous cell carcinoma of the skin and/or in-situ carcinoma of the cervix) relapsing within the 5 years before study entry * known contra-indication to anticancer compounds used * uncontrolled hypertension (systolic \>150 mmhg and/or diastolic \>100 mmhg) or history of hypertensive encephalopathy * history of inherited diathesis or recent thrombotic events * non-healing wound, active peptic ulcer or bone fracture. * major surgery or significant traumatic injury within 28 days prior to study treatment start * history of abdominal fistula, trachea-oesophageal fistula or urinary fistula * use of non steroid anti inflammatory or full dose anticoagulants or antiaggregation treatments within 10 days * pregnancy and breast feeding, premenopausal patient and no effective contraception * brain metastasis. * any unstable severe disease such as : uncontrolled cardiac or vascular disease, uncontrolled hemorrhagy, uncontrolled neuropsychiatric disorders, including dementia, uncontrolled infection or any severe disorders that may preclude study participation * patient considered geographically, socially or psychologically unable to comply with the treatment and the required medical follow-up.

Keywords: breast cancer
physical activity levels and statin therapy

Conditions: Cardiovascular Diseases; HMG COA Reductase Inhibitor Adverse Reaction; Muscle Pain

Summary: rationale: combining statin treatment and physical activity is very effective for the prevention of cardiovascular diseases. statins are well-tolerated by most patients, but may cause statin-associated muscle symptoms (sams). objective: to identify predictors for sams in statin users and to objectively assess physical activity levels and sedentary time between symptomatic and asymptomatic statin users.

combining statin treatment and physical activity is very effective for the prevention of cardiovascular diseases. statins are well-tolerated by most patients, but may cause statin-associated muscle symptoms (sams). physical activity may exacerbate sams, producing decreased physical activity levels or statin nonadherence. however, it is unknown if daily activity patterns differ between symptomatic and asymptomatic statin users. in this cross-sectional observational study the investigators will assess if physical activity levels and sedentary time differ between symptomatic and asymptomatic statins users. secondly, questionnaires will be used to assess predictors of sams.

Eligibility criteria:
inclusion criteria: * mentally able to give informed consent * statin treatment for at least 3 months exclusion criteria: * known hereditary muscle defect * known mitochondrial disease * other diseases known to cause muscle symptoms (e.g. m. parkinson or rheumatic diseases)
comparison of perioperative analgesia between intravenous paracetamol and fentanyl for rigid hysteroscopy

Conditions: Analgesia; Effect of Drug

Summary: objective of study: to compare the efficacy of intravenous paracetamol and fentanyl for intra-operative and post-operative pain relief in patients undergoing diagnostic and therapeutic hysteroscopy. hypothesis of study: there is no difference in pain control between intravenous fentanyl and paracetamol in patients undergoing hysteroscopy.

intraoperative pain assessment will be based on: hemodynamic vital (sbp, dbp. map and hr) increase 20% from the baseline will be observed and assumed pain. postoperative pain assessment will be based on: mean pain score :visual analogue pain scale (vas) of 0-10 cms will be used to assess the pain at the end of the procedure. diagnostic hysteroscopy: patients presenting with abnormal premenopausal or postmenopausal uterine bleeding, pain, infertility, intrauterine adhesions, endometrial biopsy, foreign body. therapeutic hysteroscopy: to remove iud, uterine polyps, fibroid, foreign body and submucosal fibroids, sterilization.

Eligibility criteria:
inclusion criteria: * elective surgery * american society of anaesthesiologists (asa) grade i \& ii exclusion criteria: * patients with anticipated difficult airway * gastro-oesophageal reflux disorder * body mass index (bmi) \>30kg/m2 * known hepatic disorder * known ischemic heart disease * history of hypersensitivity reactions to paracetamol and fentanyl or already taking paracetamol and fentanyl * patient experiencing the iatrogenic intra-operative uterine perforation

Keywords: paracetamolgeneral anaesthesia fentanyl general anaesthesia hysterescopy
normal values of brain oxygenation

Conditions: Cerebral Arterial Disease

Summary: new technology allows non-invasive monitoring of brain oxygenation (near-infrared-spectroscopy). however, there are no large series of normal values in various adult age groups. we hypothesised that baseline values in patients breathing room air are lower in old patients than in younger subjects and that younger patients respond increase their brain oxygenation more in response to supplemental oxygen.


Eligibility criteria:
inclusion criteria: * age between 25 and 95 years undergoing a elective surgical procedure exclusion criteria: * history of cerebral disease * dependence on supplemental oxygen

Keywords: aging