Kornimate/medical-research-clean huggingface dataset:
capeox vs observation in colorectal cancer patients with positive mrd

Conditions: Colorectal Cancer

Summary: patients with stage ⅰ colorectal cancer or stage ⅱ colon cancer usually have a good prognosis and are not recommended to receive adjuvant chemotherapy after radical surgery. with the advances in liquid biopsy technology, detection of circulating tumor dna (ctdna) can effectively identify early-stage cancer patients with minimal residual disease (mrd) after surgery. according to the growing number of mrd studies in solid tumor, colorectal cancer patients with ctdna-mrd detection have a poor clinical outcome and are likely to relapse within two years. this study aims to assess the efficacy of adjuvant chemotherapy with capecitabine plus oxaliplatin (capeox) compared with conventional observation in mrd-positive patients with stage i colorectal cancer and clinically low-risk stage ii colon cancer.


Eligibility criteria:
inclusion criteria: 1. colorectal cancer confirmed by pathology, and the tnm stage (ajcc v8) is stage i or stage ii. stage ii patients have t3 colonic adenocarcinoma with proficient mismatch-repair system (by immunohistochemistry for four mismatch repair proteins msh1, msh2, msh6, and pms2) and have no the following clinical risk factors: a) less than 12 lymph nodes examined; b) mucinous carcinoma; c) poor differentiation; d) bowel obstruction or perforation; e) lymphatic/vascular invasion, perineural invasion; f) close, indeterminate, uncertain, positive margins 2. ecog performance status 0-1 3. no neoadjuvant therapy before surgery 4. appropriate for active surveillance (i.e., no adjuvant chemotherapy) based on current practice patterns or according to the chinese society of clinical oncology guidelines for colorectal cancer (version 2022) 5. no history of other primary cancers in the past 3 years 6. no history of bone marrow, stem cell or organ transplant 7. blood samples from 7 to 21 days after surgery were tested positive for ctdna (tested by minerva mrd assay) 8. pregnancy test done within 14 days before randomization must be negative (for women of childbearing potential only) 9. voluntarily join the study and sign the informed consent document 10. no unstable or any medical condition that affects patient safety and study compliance evaluated by researchers 11. availability and provision of adequate surgical tumor tissue for molecular diagnostics exclusion criteria: 1. patients with multiple primary colorectal cancers 2. patients with another primary cancer 3. patients have the following conditions by blood test, or have obvious contraindication in adjuvant chemotherapy: 1. moderate/severe renal impairment (gfr\<30 ml/min), as calculated by the cockcroft and gault equation 2. absolute neutrophil count \<1.5×109/l 3. platelet count \< 75×109/l 4. hemoglobin \<90 g/l 5. aspartate aminotransferase/alanine aminotransferase \>2.5 × upper limit of normal 4. lactating women 5. have serious or uncontrolled medical condition that may preclude compliance with the protocol
a (5-5-5-8) technique for laparoscopic cholecystectomy

Conditions: Cholecystitis; Gallstone; Cholecystolithiasis; Cholecystitis, Chronic

Summary: the aim of this current study is to investigate the effectiveness and safety of a novel technique which is the 5-5-5-8 where the camera port is 5 mm.

more than 50 different lc procedures are described in the literature, mostly as a result of changes made by surgeons to enhance cosmetic and postoperative results. some adjustments include port size and/or number reductions relative to conventional lc usage. each of these methods has benefits and drawbacks, and each one is appropriate for usage in particular circumstances. the aim of this current study is to investigate the effectiveness and safety of a novel technique which is the 5-5-5-8 where the camera port is 5 mm. the study has two analyses: 1. at 6 month follow up 2. at 24 months follow up

Eligibility criteria:
inclusion criteria: * aged \> 18 years * patients eligible for lc during the study period exclusion criteria: * refused to participate
pd-1 inhibitor combined with neoadjuvant chemoradiotherapy plus surgery for locally advanced escc (neocrtec2101)

Conditions: Squamous Cell Esophageal Carcinoma; Esophageal Cancer; Oesophageal Cancer

Summary: the primary objective is to compare pd-1 inhibitor combined with preoperative chemoradiotherapy followed by surgery versus neo-adjuvant chemoradiotherapy followed by surgery, in terms of the overall survival time (os) in patients with stage t1-4an1-3m0 or t3-4an0m0 squamous cell esophageal carcinoma.


Eligibility criteria:
inclusion criteria: 1. histologic diagnosis of squamous cell thoracic esophageal carcinoma of stage t1-4an1-3m0 or t3-4an0m0,which is potentially resectable. 2. patients must not have received any prior anticancer therapy. 3. more than 6 months of expected survival. 4. age ranges from 18 to 70 years. 5. absolute white blood cells count ≥4.0×109/l, neutrophil ≥1.5×109/l, platelets ≥100.0×109/l, hemoglobin ≥90g/l, and normal functions of liver and kidney. 6. who ps score 0-1 7. signed informed consent document on file. exclusion criteria: 1. patients have received any prior anticancer therapy. 2. patients are diagnosed or suspected to be allergic to sintilimab,toxal or cisplatin. 3. patients with concomitant hemorrhagic disease. 4. patients who cannot tolerate surgery. 5. pregnant or breast feeding. 6. patients without informed consent because of psychological, family, social or any other factors. 7. patients with concomitant peripheral neuropathy, whose ctc status is 2 or even more. 8. patients with malignant tumors other than esophageal cancer,except for non-melanoma skin cancer, in situ cervical cancer, or cured early prostate cancer. 9. patients with history of diabetes over 10 years and unsatisfactory glycemic control. 10. patients with severe heart,lung,liver,renal dysfunction, hematopoietic system diseases, immune system diseases, cachexia or other diseases that lead to intolerance of chemoradiotherapy or surgery. 11. patients with history of autoimmune diseases, immunodeficiency, or organ and allogeneic bone marrow transplantation. 12. patients with history of interstitial lung disease or noninfectious pneumonia. 13. patients with active pulmonary tuberculosis infection, or a history of active pulmonary tuberculosis infection within one year before enrollment, or a history of active pulmonary tuberculosis infection more than one year ago without regular treatment. 14. patients with active hepatitis b ( hbv dna ≥ 2000 iu / ml or 104 copies / ml ) or hepatitis c ( hcv antibody positive ).
a sub study of the study evaluating the safety, efficacy, and pharmacokinetics of miricorilant in patients with presumed nonalcoholic steatohepatitis (nash)

Conditions: Nonalcoholic Steatohepatitis (NASH)

Summary: this optional sub study is a part of the phase 1b, open-label study is to assess the safety, efficacy of miricorilant in patients with presumed nonalcoholic steatohepatitis (nash)

this optional sub study is a part of the phase 1b, open-label study is to assess the safety, efficacy of miricorilant in patients with presumed nonalcoholic steatohepatitis (nash). all patients who participated in the current study (cort118335-861) or the corcept phase 2a nash study (cort118335-860), and who received at least one dose of miricorilant will be eligible for participation in an observational follow-up study; this includes patients who either terminated early or are study completers.

Eligibility criteria:
inclusion criteria: * have participated in either study cort118335-861 (current study) or study cort118335-860 (corcept phase 2a nash study) and received at least one dose of miricorilant; this includes patients who terminated early from the study or completed the study. * have not participated in any other clinical trial following study completion in either study cort118335-861 or study cort118335-860.

Keywords: nonalcoholic steatohepatitis nash nonalcoholic fatty liver disease
the effects of gnrha add up to routine luteal phase support on frozen embryo implantation in frozen embryo transfer .

Conditions: Infertility

Summary: the aim of the present prospective randomized controlled study was to determine the effects of gnrha add up to routine luteal phase support on frozen embryo implantation in frozen embryo transfer (fet).

some recent data have suggested a beneficial effect of gnrha administered in the luteal phase on the outcome of assisted reproduction techniques. in those studies, the dose and administration time of gnrha are inconsistent. single administration on third day after embryo transfer and multiple dose injection during luteal phase are the most common way. the gnrha included triptorelin 0.1mg, leuprorelin 1mg and buserelin 600ug et al. the exact underlying mechanism is still not clear, although it has been hypothesized that gnrh agonist either supports the corpus luteum function by inducing lh secretion by the pituitary gonadotrophin cells or stimulates the endometrium gnrh receptors . tesarik et al.postulated a direct effect of gnrh agonist on the embryo, evidenced by increased β-hcg secretion. currently, available data suggest that inadvertent administration of a gnrh agonist during a conception cycle is not accompanied by an increased risk of birth defects. on the basis of the currently strong available evidence, it appears that gnrh agonist supplementation during luteal phase significantly improve the outcome of art treatment. most of the former researches focused only on fresh embryo transfer in ivf/icsi cycles. in one prospective controlled study, a single dose of triptorelin 0.1mg was administrated 6 days after icsi in oocyte donor cycles and the implantation rate was improved significantly.gnrh agonist administration at the time of implantation enhances embryo developmental potential, probably by a direct effect on the embryo.

Eligibility criteria:
inclusion criteria: * infertile women with frozen thawed embryo transfer after hrt endometrial preparation. * more than 20 years old, and less than 37 years old. * bmi less than 28kg/m2. * more than 1 transplantable embryo after thawing. * patients should sign the informed consent and have the willing to follow up. exclusion criteria: * uterine malformation * diameter of intramural myoma more than 3cm * the thickness of endometrium less than 7mm on the progesterone supportive day.

Keywords: frozen embryo transfer,luteal support, gnrha
antihypertensive therapy in patients with comorbidities

Conditions: Adherence to Personalized EBM Antihypertensive Drug Prescriptions for Patients With Hypertension and Comorbidities in Everyday Clinical Practice

Summary: a retrospective analysis

this retrospective study will be performed using all-russian nationwide database of anonymized medical health claims and administrative data. the database holds information on diagnoses, patient data, medications, results of examinations, laboratory values, and genomic information, visits, follow up and outcomes. participating health care organizations include a mix of hospital, primary care, and specialty treatment providers spanning a wide range of geographies, age groups, and income levels. this study will analyze of outcomes according to comorbidity and antihypertensive drug prescriptions. the study will include patients who were first diagnosed with hypertension, attended the hospital as an outpatient due to hypertension, and received their antihypertensive prescription as an outpatient. to be eligible for inclusion, patients must have had comorbidities and outpatient visits or hospitalizations (for any indication) during the 3-years. the study will focused on comorbidities for choice of antihypertensive drug therapy: diabetes mellitus, dyslipidemia, gout/hyperuricemia, heart diseases, cerebrovascular diseases, and renal diseases. we going to analyze the emr of patients who had hypertension and comorbidities by cdss (medicbk) utilizing a core laboratory.

Eligibility criteria:
inclusion criteria: patients who were first diagnosed with hypertension, attended the hospital as an outpatient due to hypertension, and received their antihypertensive prescription as an outpatient. to be eligible for inclusion, patients had to have comorbidities and outpatient visits or hospitalizations (for any indication) during the 3-years. exclusion criteria: no
stereotype threat effect on cpr performance in covid-19 intensive care units: a randomised controlled mannequin study

Conditions: Stereotype-threat; COVID-19

Summary: stereotype threat (st) is an important issue that has been studied repeatedly in the psychology literature. st is the thought that a person will be negatively evaluated and judged regarding a negative stereotype that belongs to the group to which he/she belongs. most people are members of a social group associated with at least one negative stereotype. therefore, many people in society may be the target of stereotype threat. previous research has shown that the individual performance of people in groups identified with negative stereotypes, who are exposed to stereotype threat, decreases. the st may arise when there is an environment in which the skills of the person that may be affected by a stereotype associated with his/her group can be measured, or if this stereotype has become evident. in covid-19, there has been a rapid increase in the number of intensive care patients in our country and around the world. due to this rapid increase, the number of intensivist physicians is insufficient, and non-intensivist physicians from various branches are assigned to intensive care units. in social media and newspaper reports, it was stated that non-intensivist physicians have insufficient knowledge and skills in intubation and in the treatment of lung infection, and the public was asked to take precautions. however, these physicians were expected to treat lung infections and intubate the patients in intensive care units during pandemics. it is unknown to what extent such negative stereotypes, established or already existing, affect the performance of non-intensivist physicians during their appointment to the intensive care units during the pandemic. as in all other departments, the most basic task expected from doctors in intensive care units is effective basic life support applied for the treatment of cardiopulmonary arrest. cardiopulmonary resuscitation (cpr) is a basic life support model that is mandatory taught in medical schools. for this reason, it is expected that all doctors, regardless of their specialties, will be able to perform cpr effectively. the use of manikins is quite common in order to standardize cpr training and performance measurement. the aim of this study is to evaluate how non-intensivist physicians assigned to intensive care units during the pandemic are affected by stereotype threat and to investigate the necessary conditions to prevent a possible decrease in performance in these physicians.


Eligibility criteria:
inclusion criteria: 1- to have worked in the covid-19 intensive care unit during the pandemic exclusion criteria: 1. not meeting the above criteria 2. not willing to participate in the study

Keywords: stereotype threat covid-19 pandemic non-intensivist physicians cardiopulmonary resuscitation
combining h1-coil deep transcranial magnetic stimulation (dtms) and app-guided cbt in subjects with major depression disorder (mdd)

Conditions: Data Collection for Facilitation of Machine Learning Algorithm for Personalized Treatment

Summary: a naturalistic study design, in which dtms patients will be randomized to get a free add-on cbt treatment. the dtms procedure will include treatment as usual, and participants will use the app from post randomization (pre-treatment is defined as measures from the first three days of treatment) to the end of dtms treatment (post-treatment which is defined as measures from after twenty tms sessions over a minimum of four weeks), and for an additional three months of fu (fu).

participants will be recruited from those attending dtms clinics around the world (i.e.,naturalistic study design), and consenting individuals (in person consent done in the clinic on paper) will be given a random user code. this code will be specific for their version of the app, and the only link between their signature and the code will remain at the site for auditing purposes. participants will undergo treatment as usual of dtms and will use ggde twice a day. participants will be asked to complete demographic and clinical questionnaires via the ggde app, and relevant clinical questionnaires will be re-administered following treatment and during fu. the initial and all following dtms sessions will involve patients going through the stimulation procedure (the operator will record stimulation variables such as individual patient's intensity of stimulation and coil location into ggde) followed by 5 min of ggde use. the patient will indicate which statements (in that session) were most relevant and challenging to them, which will be followed by a pre-prepared psycho-education paragraph about the specific maladaptive belief addressed by the app that day. the patient will then be prompted to use the app one more time at home during the same day. patient will continue similar use during fu, with two ggde usage each day. the naturalistic design will allow the accumulation of large quantities of data in a short period of time, aiming to optimize ggde using machine learning. importantly, ggde will allow the random allocation of users to different ggde modules of the app (i.e., similar app versions with changes in specific parameters related to different depressive traits). one out of the ten modules used in this trial will include neutral (placebo) stimuli requiring the user to respond to plus/minus signs rather than mdd relevant statements.

Eligibility criteria:
inclusion criteria: * adult outpatients accepted to treatment as usual dtms with a primary dsm-v diagnosis of major depression, single or recurrent episode * capable and willing to provide informed consent * in a possession of a smartphone capable of running the ggde app. * able to adhere to the treatment schedule. exclusion criteria: investigators, site personnel directly affiliated with this study, and their immediate families (immediate family is defined as a spouse, parent, child or sibling, whether by birth or legal adoption). -
implementation of nurse-guided web-based cognitive behavioral therapy for pain management

Conditions: Chronic Musculoskeletal Pain

Summary: to see if nurse guided web based cognitive behavioral therapy (cbt) will show pain improvement in patients with all types of pain complaints.

the primary objective of this application is to test the feasibility of a care model where clinic nurses play a vital role in promoting the adoption of web-based cbt in the ambulatory medical setting. participants (n=60) in the primary care and rheumatology clinics will be randomized to one of 2 arms: (1) 6 regular telephone contacts, vs. (2) 6 computer generated email reminders (control arm) over an 8-week period. to enhance participants' motivation to engage in the web-based cbt, nurses will use motivational interviewing technique. the investigators will use outcome measures including the number of completed web-based learning modules, amount of time spent by the nurses on study-related and non-study related phone calls, health care use, and clinical variables. our proposed line of research is significant because it will potentially make cbt, a significantly underutilized treatment modality, potentially more affordable and accessible. if nurse guided web-based cbt can be shown to be effective and implementable, wake baptist health system can potentially leverage web-based cbt as one component in a multidisciplinary pain management program to prospective employers in north carolina. wake baptist may also develop its own web-based cbt for commercial use.

Eligibility criteria:
inclusion criteria: - 1. patients at the primary care or rheumatology clinic with daily pain for 6 months or longer affecting the low back, neck, hip, knee or widespread pain; 2. at least moderate in average pain severity, defined as a weekly average pain severity score of 5 or greater 24; 3. at least 18 years of age; 4. reliable phone (landline or cell), and 5. have home computer with reliable internet access. exclusion criteria: 1. planned elective surgery during the study period; 2. very severe symptoms of depression (i.e., the eight-item patient health questionnaire depression scale (phq8) score of ≥ 20); 3. ongoing unresolved disability claims; 4. inflammatory arthritis (e.g., lupus, rheumatoid arthritis, ankylosing spondylitis, etc.); 5. cancer-related musculoskeletal pain; 6. history of bipolar disorder or schizophrenia; and 7. takes daily opioid for more than one year.
effects of mindfulness based stress reduction intervention in patients with non-alcoholic fatty liver disease

Conditions: Non-Alcoholic Fatty Liver Disease; Fatty Liver, Nonalcoholic; Obesity

Summary: the purpose of this research study is to find out about the usefulness of mindfulness for weight loss and improvement of physical and mental health in people who have non-alcoholic fatty liver disease (nafld).

adding mindfulness to lifestyle changes for weight loss may improve fatty liver disease in particular and overall health and well-being in general by helping sustain weight loss and maintain a healthy lifestyle. this study will allow researchers to learn more about it. non-alcoholic fatty liver disease is a condition where there is accumulation of excess fat in the liver of people who drink little or no alcohol. it is part of the metabolic syndrome characterized by diabetes, or pre-diabetes (insulin resistance), being overweight or obese, elevated blood lipids, as well as high blood pressure, all are risk factors for the disease. in this study, participants will receive usual care, and in addition, they may be asked to participate in a mindfulness-based stress reduction program for 8 weeks. usual care involves the routine clinic follow up visits and routine lab tests and imaging studies.

Eligibility criteria:
inclusion criteria: 1. confirmed diagnosis of nafld and alt \>35 u/dl. 2. at least 2 features of metabolic syndrome (defined by adult treatment panel iii (2005 revision)). 3. age 18-80 years. 4. bmi ≥25 kg/m2. 5. capable of providing written or signed informed consent. exclusion criteria: 1. any known cause of liver disease other than nafld as confirmed by patient's history, laboratory data, and/or histological findings. 2. decompensated liver cirrhosis based on laboratory data and clinical manifestations (varices, ascites, or encephalopathy). 3. any previous experimental interventional treatment of nafld or nash within the past 3 months. 4. pre-existing diseases/conditions that could interfere with the results or the completion of this trial based on the investigator's judgment. 5. unstable metabolic syndrome and other serious chronic medical conditions. 6. unstable type 2 diabetes (any of the following): * requiring medication adjustment within the last 3 months. * patients requiring glp-1 agonists treatment. * no more than 10% modification in insulin dose if on insulin. * if on sglt-2 inhibitors, need to be on stable dose with more than 5% weight loss in the last 3 months. 7. unable to adhere to out-patient clinic management program. 8. do not speak english on a daily-user level. 9. pregnant or planning to become pregnant within the following 6 months. 10. active substance use disorder. 11. does not accept follow-ups over 1 year from time of inclusion (t0). 12. inmates.