Kornimate/medical-research-clean huggingface dataset:
real-time artificial intelligence-based endocytoscopic diagnosis of colorectal neoplasms

Conditions: Colorectal Neoplasms

Summary: colorectal cancer (crc) is the third most common malignancy and the second leading cause of cancer-related death worldwide. colonoscopy is considered the preferred method of screening for colorectal cancer, and resection of colorectal lesions can significantly reduce the incidence and mortality of colorectal cancer. in order to improve the qualitative and quantitative diagnosis of colorectal lesions, many endoscopic techniques, such as image-enhanced endoscopy (iee), including narrowband imaging (nbi), magnifying endoscopy, pigment endoscopy, confocal laser endoscopy, and endocytoscopy (ec) are applied clinically. however, with the increasing number of endoscopic resection, the costs associated with the pathological diagnosis of endoscopic resection and resection specimens increase year by year. in clinical practice, some non-neoplastic colorectal lesions may not require resection, so it is important to distinguish neoplastic from non-neoplastic during colonoscopy. the application of ec is intended to achieve the purpose of real-time histopathological endoscopic diagnosis without biopsy. several studies have shown that ec is effective in identifying the nature of colorectal lesions and judging the depth of invasion in crc. based on the endoscopic diagnosis, the endoscopist can determine the treatment plan for the colorectal lesions. the latest ec is an integrated endoscope with a contact light microscopy system with a maximum magnification of 520 x. ec can demonstrate the atypical of gland structure and cells after staining and display the super-amplified surface microvessels of the lesion under the ec-nbi mode. however, the judgment of endocytoscopic images needs a lot of experience to improve the diagnostic accuracy. moreover, endoscopists have certain subjective judgments and errors in endocytoscopic diagnosis. there is an artificial intelligence system which has been developed to identify colorectal neoplasms. however, there is still a lack of prospective clinical verification based on chinese population. in the study, the investigators performed a prospective clinical study to determine the diagnostic accuracy of artificial intelligence system.


Eligibility criteria:
inclusion criteria: * colorectal lesions exclusion criteria: * non-epithelial tumors * a history of inflammatory bowel disease * chemotherapy or radiation therapy for colorectal cancer * lesions without clear ec images * specific pathological types * familial adenomatous polyposis

Keywords: endocytoscopy artificial intelligence
effect of etoricoxib to treat chronic low back pain (0663-041)

Conditions: Recurrent Low Back Pain

Summary: study the effect of etoricoxib 60 mg and 90 mg compared to placebo to treat chronic low back pain.


Eligibility criteria:
inclusion criteria: * low back pain for previous 3 months and majority of days in last month * regular use of acetaminophen or nsaid to treat low back pain in past month * judged to be in otherwise good health exclusion criteria: * low back pain that is due to secondary causes * radicular/myelopathic pain * surgery for low back pain within the past 6 months * active lawsuit or claim pertaining to their low back pain * disease that may confound the results of the study or pose risk to the patients * corticosteroid use in past month * previous participation in mk0663 study
advanced biomarker assessment in pelvic organ prolapse

Conditions: Pelvic Organ Prolapse

Summary: this study will assess advanced biomarkers in patients with and without vaginal prolapse. assessments will be directed at vaginal fibroblasts and adipose derived stem cells.

vaginal biopsies and abdominal adipose harvest will be accomplished in patients undergoing vaginal hysterectomy for non-prolapse benign conditions (6) and pelvic organ prolapse (6). samples of tissues will be divided and portions will be snap-frozen, placed into transport medium for subsequent tissue digestion, and receive paraffin processing. cells in transport medium will be transported to the mayo collaborative research building (lab of dr. david lott) for isolation of fibroblasts and adipose derived stem cells. the other samples will be transported to the lab of dr. andre van wijnen (rst) to isolate rna and protein for mrna, microrna and additional protein analysis. isolated fibroblasts and asc's from the lab of dr. lott (mca) will be expanded and passaged 3-5 times. ascs phenotype will be confirmed by flow cytometry. cells lines will be duplicated and biobanked at the mayo clinic rochester biotrust and separately biobanked at the arizona state university lab of scaffold collaborator, dr. stephen massia. additional frozen cell lines will transported to the lab of dr. andre van wijnen for further processing. . all cells and materials will be used for testing and to advance the science of regenerative medicine. no biobanked cells or materials from this specific project will be used for any future intervention or treatment in humans.

Eligibility criteria:
inclusion criteria- * patients undergoing vaginal hysterectomy for non-prolapse benign conditions and pelvic organ prolapse * at least 18 years old * mayo clinic patient exclusion criteria- °patients who have a history of a recognized classic connective tissue disease
relationships between ultrasound data and the impact of lateral epicondylar pain

Conditions: Tennis Elbow; Epicondylitis, Lateral Humeral

Summary: our primary objective is to study the relationship between ultra sound data and the pain associated with tennis elbow.


Eligibility criteria:
inclusion criteria for tennis elbow patients: * the patient must have given his/her informed and signed consent * the patient must be insured or beneficiary of a health insurance plan * the patient is available for 90 days of follow up * pain when pressure applied to the epicondyl * pain upon forced movement of both epicondylien muscles * absence of pain upon forced movement of an epitrochlear muscle * absence of one or more skeletal-muscle problem on the homolateral arm felt by the patient to be just as problematic as his/her tennis elbow * at least one consult for pain treatment associated with tennis elbow (on the same elbow) inclusion criteria for healthy volunteers: * the patient must have given his/her informed and signed consent * the patient must be insured or beneficiary of a health insurance plan * no pain when pressure applied to the epicondyl * no pain upon forced movement of both epicondylien muscles * no neck pain * no skeletal-muscle problems in the arms during the 3 months preceding the study exclusion criteria for tennis elbow patients: * the patient is included in another study * the patient is in an exclusion period determined by a previous study * the patient is under judicial protection, under tutorship or curatorship * the patient refuses to sign the consent * it is impossible to correctly inform the patient * the patient is pregnant * the patient is breastfeeding * absence of one or more skeletal-muscle problem on the homolateral arm felt by the patient to be just as problematic as his/her tennis elbow exclusion criteria for health volunteers: * the subject is included in another study * the subject is in an exclusion period determined by a previous study * the subject is under judicial protection, under tutorship or curatorship * the subject refuses to sign the consent * it is impossible to correctly inform the subject * presence of one or more skeletal-muscle problems in the arms within the 3 months preceding the study * pain when pressure applied to the epicondyl * pain upon forced movement of both epicondylien muscles * consultation for any kind of treatment for elbow pain
effect of supplemental oxygen on maximal oxygen consumption in patients with chronic obstructive pulmonary disease

Conditions: Chronic Obstructive Pulmonary Disease

Summary: maximal consumption of oxygen (vo2max) during exercise is used in patients with chronic obstructive pulmonary disease (copd) to stratify perioperative risk. however, the impact of supplemental oxygen to prevent hypoxemia during exercise on maximal oxygen consumption and other ventilatory parameters during maximal exercise in the resting normoxic chronic obstructive pulmonary disease population is poorly defined. the investigators performed a randomized controlled trial in patients with copd who underwent cardiopulmonary exercise tests on room air and supplemental oxygen. the investigators compared maximal oxygen consumption and other ventilatory parameters in each individual subject under the two conditions.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of chronic obstructive pulmonary disease (copd). * pulmonary function characterized by forced expiratory volume in 1 second/forced vital capacity ratio\<0.7, and forced expiratory volume in one second \<80% predicted. exclusion criteria: * subjects with a recent copd exacerbation requiring emergency department visit or hospitalization within the last month. * subjects scheduled for a major pulmonary intervention in the next 3 months * subjects with severe peripheral vascular disease or other physical conditions that would preclude exercise testing
treatment approaches for preeclampsia in low-resource settings

Conditions: Preeclampsia

Summary: preeclampsia is a condition unique to pregnancy characterized by the new onset of hypertension and proteinuria. eclampsia, characterized by maternal seizures, is a serious complication increasing the risk of maternal and infant mortality and morbidity. magnesium sulfate is the drug of choice for prevention and treating convulsions in severe preeclampsia and eclampsia. magnesium sulfate is administered parenterally by intramuscular (im) or intravenous routes (iv). in general a loading dose of 4 to 5 grams of magnesium sulfate is administered intravenously followed by an im injection every 4 hours or by a continuous iv infusion. the iv regimen achieves more stable serum levels of magnesium but requires the use of an infusion pump for safe delivery and has a greater potential for inadvertent overdose. although magnesium sulfate has been demonstrated as a safe and effective drug for the treatment and prevention of severe preeclampsia and eclampsia, concerns about the safety of the drug remain. the im dosing regimen, while potentially safer, requires repeated painful im injections. these limitations in administration hinder the widespread use of magnesium sulfate despite its demonstrated benefits. the goal of this research is to develop a system of care that avoids overdose and facilitates the use of magnesium sulfate for the treatment of preeclampsia. to this end, a primary objective of this research is to demonstrate the safety of a simple, inexpensive flow controlled pump system (springfusor®). this randomized study will compare the administration of magnesium sulfate by the springfusor® controlled pump with an im regimen, the standard of care in most hospitals in india. the study will document the efficacy and acceptability of each treatment for patients and staff and compare the cost and time elements involved in providing each method.


Eligibility criteria:
inclusion criteria: * exhibit systolic blood pressure \> 140mm hg or a diastolic pressure \> 100 mm hg; * exhibit proteinuria \> 1+; * have not given birth, or be 24h or less postpartum; * exhibit urine output \>100 ml or more during the previous 4h or greater than 25 ml/h; * agree to comply with study procedures; * be \> 18 years of age; * give informed consent for study participation exclusion criteria: * eclamptic or seizing at the time of enrollment * received magnesium sulfate therapy 24h prior to study enrollment

Keywords: preeclampsia eclampsia magnesium sulfate
use of multiparametric mri in the management of head and neck cancer: a retrospective analysis

Conditions: Head and Neck Cancer; Multiparametric MRI; Cervical Lymph Node

Summary: the investigators aim to identify specific mri parameters that could improve diagnostic accuracy of metastatic cervical lymph nodes in patients with a squamous cell carcinoma in the head and neck region.

background:the locoregional control rates in patients with advanced head and neck cancer remain suboptimal. accurate diagnosis of metastatic cervical lymph nodes remains challenging. technological advances in magnetic resonance imaging (mri) enable to quantify diffusion and perfusion of the tumour and its surrounding tissues, which could improve diagnostic performance. objectives: the investigators aim to identify specific mri parameters that could improve diagnostic accuracy of metastatic cervical lymph nodes in patients with a squamous cell carcinoma in the head and neck region. study design: a retrospective study will be set up to explore the diagnostic performance of the selected mri parameters to differentiate between tumoural and non-tumoural cervical lymph nodes in patients with a histologically confirmed head and neck tumour ('affected group') or histologically confirmed whartin tumour or pleomorphic adenoma of the parotid gland, without malignant transformation ('control group'). patients will be screened for inclusion in the analysis if they had a routine preoperative multiparametric mri, according to a standardised protocol, between the 1st of december 2016 and the 30th of september 2018. all mr images will be screened by the resident to select those patients with one or multiple clearly distinguishable metastatic cervical lymph node(s), which can be clearly correlated with the final pathology report. other strict inclusion criteria are described in detail in the protocol.

Eligibility criteria:
inclusion criteria: * patients that received a pretreatment multiparametric mri according to a standardized protocol between december 2016 and december 2018 * histophatologically proven scc in the head and neck region * one or multiple clearly distinguishable cervical lymph node(s), that can be unambiguously correlated with the pathology report exclusion criteria: * patients not fulfilling abovementioned criteria * patients with thyroid or skin cancer * considerable artefact on mri * previous surgery, irradiation or chemotherapy in the hn region
a study of lubiprostone to treat constipation

Conditions: Constipation

Summary: the main aim of this study is to check the side effects from lubiprostone in adults with constipation. participants will be treated with lubiprostone according to their clinic's standard practice.

this is a prospective, observational post-marketing surveillance study of lubiprostone in participants with constipation. the study will assess the safety and effectiveness of lubiprostone for its approved indication with real-world setting in south korea. the study will enroll approximately 3000 participants. the data will be collected prospectively at the study sites will be recorded into electronic case report forms (e-crfs). all the participants will be assigned to a single observational cohort: • all participants the study will be conducted in south korea. the overall duration of the study will be approximately 6 years. data collection will be based on routinely scheduled visits during a 12-month follow up period for each participant up to a final follow-up when the participant discontinues treatment or at the end of follow-up period for any participants still taking lubiprostone. note: this product was divested from takeda to jeil in 2022.

Eligibility criteria:
inclusion criteria: 1. south korean adult. 2. with constipation caused by: * chronic idiopathic constipation (cic), or * opioid-induced constipation (oic) from treatment for chronic, non-cancer pain, including participants with chronic pain related to prior cancer or its treatment who do not require frequent (example weekly) opioid dosage escalation. 3. is newly prescribed (first incident) and initiates lubiprostone for the treatment of constipation. exclusion criteria: 1. treated with lubiprostone outside of the locally approved label in south korea. 2. participating in any other clinical study investigating one (or more) of the approved indications of lubiprostone.

Keywords: drug therapy
durvalumab with or without olaparib in patients with endometrial cancers regulatory post marketing surveillance

Conditions: Endometrial Cancer

Summary: objectives of this study are to assess the safety and effectiveness of durvalumab with or without olaparib (hereinafter "the study drug") in a real world setting in patients who are prescribed with the study drug under the approved indication in korea. this is a multicenter, prospective, observational, real world treatment study. patients treated as part of routine practice at korean healthcare centers by investigators will be identified and considered for inclusion in the study. the period of this study is expected to run for 4 years from the approval date of the indication for this study. approximately 50 patients are expected to be enrolled during the study. patient will be followed for approximately 12 months from the first dose or up to 90 days after treatment discontinuation if the study drug is administered for less than 12 months, unless they withdraw consent, are lost to follow-up or death.

primary objective: to assess the safety of the study drug in patients prescribed with the study drug under the approved indication(s) in korea secondary objective: to assess effectiveness of the study drug in patients prescribed with the study drug under the approved indication(s) in korea exploratory objective: to assess the safety and effectiveness of the study drug in patients prescribed with the study drug under the approved indication(s) in korea by treatment/ mmr status

Eligibility criteria:
inclusion criteria: 1. patients eligible for the study drug according to the approved label in korea 2. provision of a signed and dated written informed consent by the patient or their legally acceptable representative exclusion criteria: 1. participation in any concurrent interventional trials during the period of the study drug treatment 2. other off-label indications according to the approved label in korea
gemcitabine plus bevacizumab in locally recurrent or metastatic breast cancer

Conditions: Metastatic Breast Cancer; Locally Advanced Breast Cancer

Summary: to determine how long gemcitabine and bevacizumab will stop the cancer from growing in patients with advanced breast cancer.


Eligibility criteria:
inclusion criteria: * must be female and greater than or equal to 18 yrs of age * participants must have confirmed cancer with measurable or evaluable, locally recurrent or metastatic disease. * participants must have received a taxane as neo-adjuvant and/or adjuvant therapy * participants may have received prior hormone therapy for locally recurrent or metastatic disease exclusion criteria: * participants with breast cancer overexpressing human epidermal growth factor receptor 2 (her2) gene amplification * prior chemotherapy or targeted therapy for metastatic breast cancer * prior treatment with gemcitabine, trastuzumab, lapatinib or bevacizumab in any setting * history of, or active brain mets * major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to treatment, or anticipation of need for major surgical procedure during course of study * prior history of high blood pressure crisis * have a serious, nonhealing wound, ulcer, or bone fracture

Keywords: breast neoplasm
efficacy and safety of toludesvenlafaxine hydrochloride sustained-release tablets versus desvenlafaxine succinate sustained-release tablets targeting anhedonia in patients with major depression disorder

Conditions: Anhedonia

Summary: the purpose of this study is to evaluate efficacy and safety of toludesvenlafaxine hydrochloride sustained-release tablets in the treatment of anhedonia in patients with major depression disorder compared to desvenlafaxine succinate sustained-release tablets, to provide evidence-based basis for clinical rational drug use.

the study included 80 patients with major depression disorder (aged 18 to 65 years) who meet the diagnostic criteria for depression in the fifth edition of the diagnostic and statistical manual of mental disorders (dsm-5). eligible patients were randomly assigned (1:1) to 8-week treatment with toludesvenlafaxine hydrochloride sustained-release tablets (n=40) or desvenlafaxine succinate sustained-release tablets(n=40), followed up at period of enrollment as baseline and at the end of 2th, 4th and 8th weeks. adverse events were recorded.

Eligibility criteria:
inclusion criteria: * subjects meet the diagnostic criteria for major depression disorder in the diagnostic and statistical manual of manual disorders, fifth edition (dsm-5); * male or female aged ≥18 and ≤65 years; * subjects who have a montgomery-asberg depression rating scale (madrs) total score ≥24 points; * subjects who have a total score of snaith-hamilton pleasure scale (sharps) ≥3 points; * subjects voluntarily participate in the study and sign the informed consent form. exclusion criteria: * allergic or known to be allergic to toludesvenlafaxine hydrochloride sustained-release tablets and desvenlafaxine succinate sustained-release tablets; * subjects have a severe self-injury/clear suicide attempt or behavior; scores on madrs items factor 10 ≥4 points; * subjects who meet the diagnostic criteria for any other psychotic disorders (except for major depression disorder) in dsm-5, or those who have substance disorders or drug abuse within the past six months; * individuals with severe and unstable physical diseases such as cardiovascular disease, liver disease, kidney disease, blood disorders, and endocrine disorders; * hypertensive patients with poor blood pressure control (systolic blood pressure (sbp) ≥140 mmhg or diastolic blood pressure (dbp) ≥90 mmhg at screening); * total bilirubin (tbil) values 1.5 times / alanine aminotransferase (alt) or aspartate aminotransferase (ast) 2 times / creatinine (cr) 1.2 times higher than the upper limit of normal, or thyroid-stimulating hormone (tsh) outside the normal range at screening; * electrocardiogram (ecg) abnormalities that are clinically significant at period of screening and that the investigator considers as inappropriate conditions for inclusion, such as qtc interval \>450 ms in men and qtc interval \>460 ms in female; * pregnant or lactating women, recent planned pregnancy and unable to ensure effective contraception during the period; * other conditions that the investigator considers the participant is not suitable for the study.