Kornimate/medical-research-clean huggingface dataset:
colchicine in covid-19: a pilot study

Conditions: COVID-19

Summary: this is an interventional, pilot, multicenter, randomized, open-label, phase 2 study, enrolling patients with covid-19 disease. one-month rate of entering the critical stage (either a. respiratory failure occurs and requires mechanical ventilation; b. patients combined with other organ failure need icu monitoring and treatment; c. death) is the primary endpoint.

this is an interventional, pilot, multicenter, randomized, open-label, phase 2 study, enrolling patients with covid-19 disease. participants will be randomized in a 1:1 ratio to receive colchicine plus current care versus current care. one-month rate of entering the critical stage (either a. respiratory failure occurs and requires mechanical ventilation; b. patients combined with other organ failure need icu monitoring and treatment; c. death) is the primary endpoint. secondary objectives are trend of white blood cell count, change of the "sequential organ failure assessment" (sofa), rate of biochemical criterion (ck, alt,ferritin) recovery, rate of disease remission and safety of colchicine.

Eligibility criteria:
inclusion criteria: * informed consent for participation in the study * virological diagnosis of sars-cov-2 infection (real-time pcr) * hospitalized due to clinical/instrumental diagnosis of pneumonia * oxygen saturation at rest in ambient air ≤94% * pao2/fio2 ratio of 350 to 200 exclusion criteria: * known hypersensitivity to colchicine or its excipients * severe diarrhea * patients who cannot take oral therapy * pregnant and lactating patients * patients with severe cardiac, renal insufficiency (creatinine clearance (ccl) \<30 ml / min) * patients with kidney or liver damage \[(ast or alt\> 5 times the normal limits in international units (uln)\]; or are taking cyp3a4 enzyme - p glycoprotein inhibitors. * known other clinical condition that contraindicates colchicine and cannot be treated or solved according to the judgement of the clinician * neutrophils \<1.000 / mmc * platelets \<50.000 / mmc * bowel diverticulitis or perforation * patients already in icu or requiring mechanical ventilation * patients receiving tocilizumab * patients already enrolled in other clinical trials

Keywords: covid covid-19 coronavirus sars-cov-2 colchicine il-1
efficacy and safety of intradermal acupuncture for major depressive disorder

Conditions: Major Depressive Disorder

Summary: major depressive disorder (mdd) is a common mental illness that severely affects the health and quality of life of patients. treatment with acupuncture alone or a combination of appropriate adjuncts has been reported to be significantly effective in reducing the severity of mdd, relieving patients' somatic symptoms and improving sleep. this study will focus on the intradermal acupuncture, which is more convenient, gentler and has longer lasting effects. the aim is to study the efficacy and safety of intradermal acupuncture for mdd, and to preliminarily explore the central nervous mechanisms by which it exerts its therapeutic effects.

a total of 90 patients with mdd who meet the inclusion criteria will be included in the study. participants will be randomly assigned 1:1:1 to the waiting list group (patients in this group will be treated with selective 5-hydroxytryptamine reuptake inhibitors (ssris) only), sham intradermal acupuncture combined with ssris (sia) group and active intradermal acupuncture combined with ssris (aia) group. the study will assess the efficacy and safety of intradermal acupuncture for mdd and examine whether intradermal acupuncture reduces side effects and improves the efficacy of ssris for mdd. in addition, the study will use magnetic resonance imaging (mri) to study the possible central mechanisms by which intradermal acupuncture exerts its antidepressant effects.

Eligibility criteria:
inclusion criteria: 1. patients diagnosed with mdd according to the international classification of disease-10 (icd-10); 2. aged between 18 and 60 years (no limitation on gender); 3. no depression-related treatment in the past two weeks, except ssris; 4. patients undergoing mri and mrs should be right-handed and free of traumatic brain injury, claustrophobia or metal implants; 5. written informed consent is obtained by the person or guardian. exclusion criteria: 1. icd-10 diagnoses: schizophrenia, bipolar disorder, manic episode or other psychotic disorders; alcohol and drug addiction; 2. significant skin lesions, severe allergic diseases, tumors, and severe or unstable internal diseases involving the cardiovascular, digestive, endocrine, or hematological system; 3. acute suicidal tendency; 4. allergy to adhesive tape and fear of intradermal acupuncture; 5. pregnancy and lactation; 6. mental retardation and difficult to cooperate with doctors. 7. participating in other clinical trials.

Keywords: major depressive disorder intradermal acupuncture magnetic resonance imaging
ileal reservoir length and functional outcome in ileal pouch-anal anastomosis: an assessor-blinded, randomized controlled trial

Conditions: Ulcerative Colitis; Familial Adenomatous Polyposis

Summary: the aim of this randomized controlled trial is to compare outcome after construction of an ileal (j-shaped) reservoir of 10 versus 15 centimeters in primary ileal pouch-anal anastomosis surgery.

the primary aim of this randomized controlled trial is to compare functional outcome in terms of bowel function correlated with quality of life for patients who undergo primary ileal pouch-anal anastomosis surgery with an ileal (j-shaped) reservoir length of either 10 cm or 15 cm. secondary aims include health-related quality of life measures and postoperative complications.

Eligibility criteria:
inclusion criteria: * undergoing ileal pouch-anal anastomosis (ipaa) for ulcerative colitis or familial adenomatous polyposis (fap) (implying a normal sphincter function as judged by history and clinical examination) * signed informed consent * able to perform both a small (10 cm) and medium-size (15 cm) pouch with adequate reach and no tension as determined subjectively by the surgeon intraoperatively

Keywords: ileal pouch-anal anastomosis ulcerative colitis familial adenomatous polyposis randomized controlled trial pouch function quality of life complications
endostar combined with nvb and ddp second-line treatment of advanced esophageal squamous cell carcinomas

Conditions: Esophageal Squamous Cell Carcinoma

Summary: the aim of this study is to explore whether endostar combined with nvb and ddp as treatment could improve progression-free surial time (pfs) and to evaluate the safety of the chemotherapy regimens

this study is to explore whether endostar combined with nvb and ddp as treatment could improve progression-free surial time (pfs) and to evaluate the safety of the chemotherapy regimens used as second-line treatment of advanced esophageal squamous cell carcinomas

Eligibility criteria:
inclusion criteria: 1. histologically proven primary thoracic esophageal squamous cell carcinoma 2. according to the esophageal ajcc2009 7th to determine new stage iv esophageal cancer 3. the subject has pd after first-line chemotherapy or radiation within a year 4. presence of at least one index lesion measurable by ct scan or mri according to recist 1.1 5. can eat more than liquid diet; no signs before esophageal perforation 6. 18\~75 years 7. ps:0-1 8. life expectancy of ≥ 3 months 9. anc ≥ 2×109/l，plt ≥ 100×109/l，hb ≥ 90g/l 10. tb ≤ unl； alt/ast ≤ 2.5×unl，akp ≤ 5×unl 11. ccr≤ unl,scr≥60 ml/min 12. normal electrocardiogram (ecg), the body had no unheal wounds 13. radiotherapy before within the scope of the normal dose and not affect subsequent treatment 14. prior to biological agents, especially e. coli genetically engineered products without severe allergic reactions 15. signed written informed consent exclusion criteria: 1. breast-feeding or pregnant women, no effective contraception if risk of conception exists 2. chronic diarrhea, enteritis, intestine obstruction which are not under control 3. esophageal obstruction cannot eat liquid completely, esophagus have deep ulcer perforation or hematemesis; esophageal cancer common complications such as anastomotic leakage, serious lung complications, etc. 4. a second primary tumor (except skin basal cell carcinoma) 5. the original serious heart disease, including: higher risk of congestive heart failure, unable to control arrhythmia, unstable angina, myocardial infarction, severe valvular heart disease, and resistant hypertension 6. with uncontrol nerve, mental illness or mental disorders, compliance is poor, can't cooperate with accounts and response to treatment; primary brain tumors or cns metastases illness did not get a control, has obvious cranial hypertension or nerve mental symptoms 7. with bleeding tendency 8. has inherited bleeding evidence of physical or blood coagulation disorder 9. with clear chemotherapy drug allergy 10. other researchers believe that patients should not participate in this testing
a trial of shr0410 injection in postsurgical pain management

Conditions: Postsurgical Pain

Summary: the study is being conducted to evaluate the efficacy, safety of shr0410 injection and to explore the reasonable of shr0410 injection for pain management after orthopaedic surgery.


Eligibility criteria:
inclusion criteria: 1. able and willing to provide a written informed consent； 2. subjects requiring elective general anesthesia orthopedic surgery； 3. male or female； 4. meet the body mass index standard； 5. conform to the asa physical status classification； 6. negative pregnancy test. exclusion criteria: 1. subjects with a history of myocardial infarction or unstable angina pectoris； 2. subjects with atrioventricular block or cardiac insufficiency； 3. subjects with a history of malignancy ； 4. subjects with a history of stroke； 5. subjects with a history of mental illness； 6. subjects with a history of difficult airway； 7. random blood glucose ≥11.1mmol/l； 8. subjects with poor blood pressure control； 9. abnormal values in liver or renal function； 10. subject with a history of substance abuse and drug abuse； 11. allergic to drugs that may be used during the study； 12. use other drugs that affect the analgesic effect before randomization, and the time from the last use to randomization is shorter than 5 half-lives； 13. participated in clinical trials of other drugs (received experimental drugs)； 14. other circumstances that the investigator judged inappropriate for participation in this clinical trial.
prognostic performance of a chemogram in patients with bladder cancer.

Conditions: Urinary Bladder Neoplasms

Summary: the aim of the study is to evaluate chemogram in patients with intermediate-grade superficial bladder cancer and patients with infiltrating bladder cancer, who are likely to be treated according to the standard procedure. this project is based on the premise that treatments - notably chemotherapy - are standard, but that each cancer is unique. it is therefore necessary to personalize the treatment for each patient, while at the same time proposing an approach that is economically bearable for the healthcare system. for both types of bladder tumor, chemotherapy is used either as an alternative to immunotherapy, or as an adjuvant to surgery. its use is therefore based on its effectiveness in reducing post-treatment recurrence.

the project is based on the premise that treatments - particularly chemotherapy - are standard, but that each cancer is unique. it is therefore necessary to personalize treatment for each patient, while proposing an approach that is economically viable for our healthcare system. the chemogram is inspired by the principle of antibiograms, since it tests, for a given patient and in conjunction with oncologists, different chemotherapeutic or targeted treatment options based on clinical and anatomopathological data. these tests are carried out in vitro in academic research laboratories. with this study, its proposed a "proof of concept" for the clinical use of chemograms in patients with superficial or infiltrating bladder cancer. the use of chemograms will have no impact whatsoever on the patient's treatment, which will be administered according to standard practice. nevertheless, this study may help determine whether chemograms can detect tumor sensitivity to certain anti-cancer treatments. in the years to come, the aim of this research work is to be able to guide the therapeutic management of patients whose tumours are resistant to the treatment envisaged (tumours with intrinsic resistance to treatment). this will avoid unnecessary treatments for the patient, often with very serious side effects. for these two types of bladder tumour, the use of a chemogram to detect the tumour's chemosensitivity would make treatment more effective and rapid.

Eligibility criteria:
inclusion criteria: * major patient * patient with suspected bladder cancer likely to be treated with chemotherapy * patient affiliated to a social security scheme exclusion criteria: * insufficient tumor volume * patient under guardianship * pregnant or breast-feeding women * patient opposed to participation in the study

Keywords: urinary bladder neoplasms chemogram
prognosis of right ventricular dysfunction assessed by speckle tracking in postoperative thoracic surgery

Conditions: Right Ventricle; Thoracic Surgery

Summary: in postoperative thoracic surgery (lobe resection, pneumonectomy or wedge resection), cardiovascular complications are the most frequent (10 to 15%) with a significant morbi-mortality rate. right ventricular (rv) dysfunction is a complication that can be multifactorial in post thoracic surgery. the rv longitudinal shortening fraction (rv-lsf) is a new 2d-ste parameters able to more accurately detect patients with rv dysfunction compared to conventional echocardiographic parameters. this project is a single-center, prospective, interventional study of patients hospitalized at the amiens university hospital for scheduled thoracic surgery. tte is performed preoperatively, at day 2 and day 15 following the thoracic surgery. echocardiographic parameters will be measured by an echocardiographic expert in offline with a dedicated software. mace criteria will be collected at day 2, day 15 and day-30 following the thoracic surgery.


Eligibility criteria:
inclusion criteria: * adult patient (\>18 years) * patient hospitalized at the amiens university hospital for scheduled thoracic surgery (lobectomy, pneumonectomy, wedge resection). * surgery by thoracotomy or video-assisted thoracic surgery * information of the patient and collection of his non-opposition exclusion criteria: * patient with poor echogenicity on tte not allowing evaluation of 2d-ste or conventional parameters of the rv. * patient with a rapid supraventricular rhythm disorder (hr \> 100) at the time of tte * patient under mechanical ventilation * patient under extracorporeal membrane oxygenation * patients under guardianship or legal protection * patients whose clinical condition does not allow for their non-opposition * pregnant women

Keywords: right ventricle speckle tracking thoracic surgery
treatment of mirizzi syndrome

Conditions: Mirizzi Syndrome; Cholelithiasis; Acute Cholecystitis

Summary: mirizzi syndrome is an infrequent complication of long-standing cholelithiasis. extrinsic compression of the common hepatic duct is usually caused by an impacted stone in hartmann's pouch or cystic duct resulting in the development of cholecystobiliary fistula. this syndrome is classified based on the presence and severity of cholecystobiliary fistula. mirizzi syndrome is challenging to diagnose preoperatively and may require complex biliary surgical procedures for resolution. endoscopic treatment is a safe alternative with a high success rate. single-operator cholangioscopy combined with lithotripsy has been shown to have a 90-100% success rate in the treatment of biliary stones. herein, a single center experience treating mirizzi syndrome with single-operator cholangioscopy guided electrohydraulic lithotripsy is presented. difficult management of mirizzi syndrome has led to research of new treatment options to minimize the risk of high rate complications. single-operator cholangioscopy in combination with laser lithotripsy is an adequate and safe alternative for the treatment of this condition.


Eligibility criteria:
inclusion criteria: * patients older than 18 years old * patients with a preoperative diagnosis of mirizzi syndrome * patients with a common bile duct dilatation exclusion criteria: * patients younger than 18 years old * patients with an inconclusive biliary diagnosis * patients without a diagnosis of mirrizi syndrome * patients without common bile duct dilatation
molecular mechanisms of clinical resistance to targeted therapy among patients with breast cancer

Conditions: Breast Cancer

Summary: the purpose of this study is to learn why certain drugs stop working in patients.in lab studies, tumors become resistant in several ways. specific molecules seem to change and this may be why therapy stops working. however, we do not know if the same molecules change in patients. this study is being done to see if they do change. if we learn more about how patients become resistant, we may be able to offer better treatment in the future.


Eligibility criteria:
inclusion criteria: all patients: * diagnosed with breast cancer. * patient must be able to consent to a biopsy * patient must be able to safely undergo a secondary biopsy, if needed. cohort 1 * patients who previously received treatment with anti-her2 therapy (including trastuzumab, pertuzumab, tdm1, lapatinib, neratibin, or ds8201) as part of adjuvant chemotherapy and now have progressive or recurrent breast cancer or, patients who previously (or currently) received anti-her2 therapy as part of a regimen for metastatic breast cancer and subsequently experienced. * evidence of disease progression or recurrence after prior therapy (e.g. radiologic progression by recist criteria or new metastasis). * prior tumor biopsy (may be original) defined as her2+ by amplification by fish (\>1.9 gene copy number) or ihc 3+. cohort 2 * patients who previously received treatment with hormonal therapy (including aromatase inhibitors or serms or serds) as a part of adjuvant therapy and now have progressive or recurrent breast cancer or patients who previously (or currently) receive hormonal therapy as part of a regimen for metastatic breast cancer and subsequently experienced evidence of disease progression. cohort 3 * patients not eligible for cohorts 1 or 2. exclusion criteria: * patients who are unable to consent to a biopsy. * patients for whom a repeat biopsy would be medically unsafe

Keywords: recurrent breast cancer male breast cancer stage iv breast cancer
graded motor imagery in women diagnosed with genito-pelvic pain penetration disorder

Conditions: Genito-Pelvic Pain/Penetration Disorder

Summary: the goal of this clinical trial is to assess the effects of a graded motor imagery (gmi) programme in women diagnosed with genito-pelvic pain penetration (gppd) disorder. the main questions it aims to answer are: does a gmi programme reduce pain intensity levels in women diagnosed with gpppd? does a gmi programme have an effect on sexual function in women diagnosed with gpppd? participants will undergo a gmi programme and will be tested prior to and after the intervention to assess if the programme has a significant effect with regards to pain intensity and other pain-related outcome

graded motor imagery has been extensively used in several populations suffering pain-related disorders. it triggers cortical stimulation gradually in order to have an effect on the alterations that might have occured due to pain women suffering from genito-pelvic pain penetration disorder deal with persistent pelvic pain that is no longer responding to a noxious stimulus, therefore this clinical presentation could have several cortical alterations implicated. the main goal of this study is to assess if a graded motor imagery programme is able to reduce pain intensity and improve sexual function in women diagnosed with genito-pelvic pain penetration disorder.

Eligibility criteria:
inclusion criteria: * women diagnosed with persistent pelvic pain * pain suffered for a period of a minimum of 3 months * adult (\>18 years) women exclusion criteria: * medical condition that logically explains the presence of pain * pain suffered for a period of less than 3 months

Keywords: genito-pelvic pain/penetration disorder pelvic pain dyspareunia graded motor imagery physical therapy
peep test and gas exchange in ali/ards patients

Conditions: Acute Respiratory Distress Syndrome

Summary: the investigators aim to study the effect of different levels of peep in ali/ards patients on gas exchange.

in a population of ali/ards patients during mechanical ventilation we will evaluate the effect of different levels of peep on gas exchange and dead space.

Eligibility criteria:
inclusion criteria: * ali/ards patients requiring mechanical ventilation exclusion criteria: * hemodynamic instability * barotrauma

Keywords: gas exchange dead space respiratory failure ali/ards patients
phase ii study of systemic screening in pathologic node positive breast cancer

Conditions: Breast Cancer; Node-positive Breast Cancer

Summary: the purpose of the study is to determine the frequency of systemic metastasis in node positive breast cancer following chemotherapy and surgery. participants will be asked to spend about 6 months in this study. participants will undergo a computed tomography (ct) screening of the thorax, abdomen, and pelvis at baseline prior to adjuvant radiation therapy and another ct screening of the thorax, abdomen, and pelvis at 6 months if the baseline ct is found to be negative.


Eligibility criteria:
inclusion criteria: * histologic diagnosis of breast cancer with documentation of er/pr/her2 status. * hr+ will be defined as er and/or pr ≥ 10%. to be classified as her2+ disease, overexpression of her2 by either ihc or in-situ hybridization is necessary as defined by the asco / cap guidelines27. triple negative will be classified as er and pr \<10% and her2-. * node positive her2+ and triple negative breast cancer (ypn+) following receipt of neoadjuvant chemotherapy. hr+/her2- patients should have ypn2 or ypn3 disease following receipt of neoadjuvant chemotherapy and surgery. * patient must have completed a minimum of 8 weeks of standard neoadjuvant chemotherapy consisting of an anthracycline and/or taxane-based regimen. to include her2 directed therapy for her2+ patients. * age ≥ 18. * life expectancy ≥ 6 months. * eastern cooperative oncology group performance status 0 to 2. * patients must be able to understand and the willingness to sign an informed consent for study procedures. * ability to understand and stated willingness to comply with all study procedures and availability for the duration of the study. exclusion criteria: * prior diagnosis of systemic metastases. * patients with prior history of non-breast cancer malignancies should have ned ≥ 2 years excluding adequately treated non-melanoma skin cancer, in situ cancer of the cervix or bladder. * contraindication towards ct iv contrast. * chronic kidney disease stage iv or v or end stage renal disease (crcl \<30 ml/min).