Kornimate/medical-research-clean huggingface dataset:
comparison of morbidity of submucosal dissection resection of giant colon lesions versus surgery: a national multicenter study (mordigo)

Conditions: Colonic Neoplasms

Summary: propose a one-piece endoscopic resection such as endoscopic submucosal dissection (esd) rather than surgery for benign lesions and superficial t1 cancers colorectal cancers offers comparable efficacy with better tolerability. this approach is all the more in the rectum, even for giant lesions lesions (over 8cm), as rectal surgery is particularly morbid, with particularly morbid, with a functional impact that can impact, whereas rectal esd is less prone to complications fewer complications than in the colon. colonic esd for giant lesions is a longer and more morbid more time-consuming and morbid than for smaller lesions, the question of colonic surgery in this indication. this indication. in order to compare the morbidity data of patients of giant lesions with those of colectomy, a control group colectomy, a surgical control group will be set up, including patients including patients having undergone surgery for in situ t1 or t2 in situ colon cancer. surgical resections of resection of benign lesions is generally not indicated not indicated and would not provide the necessary necessary for a comparison. t3 and t4 lesions with their own their own morbidity will be excluded.


Eligibility criteria:
inclusion criteria: * group a : * patients from the fecco cohort * who have undergone esdresection of a giant lesion, defined by a fresh specimen measuring more than 8cm long axis, of the colon * between september 2019 and 2022 * major * patient affiliated to a social security scheme group b: * patients from the registre des tumeurs digestives registry (brest university hospital) * having undergone colectomy with lymph node dissection for intramucosal colonic adenocarcinoma, t1 or t2 colonic adenocarcinoma * between september 2019 and 2022 * adults * patient affiliated to a social security scheme exclusion criteria: * - rectal lesion ; * patients under legal protection (guardianship, curatorship, ...) or deprived of liberty ; * refusal to participate.

Keywords: endoscopy submucosal dissection colonic neoplasms colonic surgery
the combination of high-dose dexamethasone and acetylcysteine as the treatment of newly-diagnosed itp

Conditions: Immune Thrombocytopenia

Summary: a single-arm, open-label study to evaluate the efficacy and safety of acetylcysteine plus high-dose dexamethasone in adults newly diagnosed with primary immune thrombocytopenia (itp).

this is a prospective, open-label, phase ii, single-arm interventional trial performed in a single center in china. the investigators explore the efficacy and safety of acetylcysteine plus high-dose dexamethasone in adults newly diagnosed with primary immune thrombocytopenia.

Eligibility criteria:
inclusion criteria: 1. clinically confirmed immune thrombocytopenic purpura (itp) newly diagnosed 2. platelet count less than 30×10\^9/l on two occasions or platelets above 30×10\^9/l combined with bleeding manifestation (who bleeding scale 2 or above) 3. subject is ≥ 18 years and ≤80years 4. subject has signed and dated written informed consent. 5. fertile patients must use effective contraception during treatment and observational period 6. negative pregnancy test exclusion criteria: 1. have an impaired renal function as indicated by a serum creatinine level \> 2.0 mg/dl 2. have an inadequate liver function as indicated by a total bilirubin level \> 2.0 mg/dl and/or an aspartate aminotransaminase or alanine aminotransferase level \> 3×upper limit of normal 3. have a new york heart classification iii or iv heart disease 4. have a history of severe psychiatric disorder or are unable to comply with study and follow-up procedures 5. have active hepatitis b or hepatitis c infection 6. have a hiv infection 7. have active infection requiring antibiotic therapy within 7 days prior to study entry 8. are pregnant or lactating women, or plan to become pregnant or impregnated within 12 months of receiving study drug 9. previous treatment with rituximab 10. previous splenectomy 11. had previous or concomitant malignant disease 12. not willing to participate in the study. 13. expected survival of \< 2 years 14. intolerant to murine antibodies 15. immunosuppressive treatment within the last month 16. connective tissue disease 17. autoimmune hemolytic anemia 18. patients currently involved in another clinical trial with evaluation of drug treatment

Keywords: immune thrombocytopenia acetylcysteine
veritas laparoscopic paraesophageal hiatal hernia (peh) repair pilot trial

Conditions: Hiatal Hernia

Summary: this is an investigator initiated pilot study to observe the short-term outcomes (a follow-up period of up to six months) of patients who undergo a laparoscopic paraesophageal hiatal hernia (peh) repair using the veritas® collagen matrix brand biological mesh. this is a preliminary study at the university of washington. a peh occurs when the stomach protrudes through the diaphragm next to the esophagus. the chance of recurrence of a hiatal hernia after laparoscopic peh repair is between 20-40% within 6 months.during laparoscopic peh repair, a mesh-type product is used as a scaffold. the mesh serves as a reinforcing material during the surgical repair. it is cut to the appropriate size needed for the hernia and sutured to the surrounding diaphragmatic tissue. there are many different types of meshes available on the market, and vary in the degree of manageability, strength, and adherence. although surgical meshes work on the same principal, the variance between materials may affect patient outcomes. there is evidence that a biologic mesh, specifically one derived from small intestinal submucosa (sis), decreases the short-term (6-month) recurrence rates compared to a synthetic mesh or another type of biologic mesh. a biologic mesh, serving as a scaffold, will be replaced by the patient's own tissue after about 6 months. theoretically, this would prevent the possible complications associated with synthetic mesh including mesh erosion into the esophagus or stricture of the esophagus. there are some case series showing similar short-term results between the different biologic meshes, but there is no direct comparative data.


Eligibility criteria:
inclusion criteria: a. subjects must have a documented symptomatic paraesophageal hernia that: * 1. is greater than 5 cm hiatal hernia on upper gastrointestinal (ugi) series * 2. has evidence that the stomach or other viscera is present in the hernia and does not spontaneously reduce from the mediastinum * 3. has significant symptoms or signs of a paraesophageal hernia: heartburn, dysphagia, chest pain, shortness of breath, post-prandial abdominal pain, early satiety, odynophagia or chronic anemia b. consenting adult ≥18 years \~ documentation of informed consent will be recorded in the research records c. must be able to participate in follow-up evaluations (subjects must be fully cognitive) d. has a telephone e. free of cognitive or speech impairment exclusion criteria: a. previous operation of the esophagus or stomach b. associated gastrointestinal diseases that require extensive medical or surgical intervention that might interfere with quality of life assessment (e.g. crohn's disease) c. emergent operation for acute volvulus (twisting/rotation of the bowel leading to obstruction)

Keywords: veritas® collagen matrix, hiatal hernia
a study to determine the cartography of virologic reservoir related to antiretroviral concentrations in hiv-1 chronic patients treated by a first line treatment containing bictégravir, emtricitabine and ténofovir alafénamide

Conditions: HIV-1-infection

Summary: the main objective of the study is to evaluate the diffusion of bictegravir and associated backbone (tenofovir alafenamide and emtricitabine) in hiv-1 chronic patients in the main putative reservoirs, namely inguinal lymph nodes, rectal, fat tissues and sperm.

anrs ep69 bictevoir is an interventional pilot study, multicenter, involving the use of human biological samples. 34 hiv-1 infected male subjects, from bicetre, la pitié salpêtriere, antoine-béclère, necker, hôtel-dieu and saint-antoine hospitals will be recruited. different samples will be performed during one single day: * blood samples * rectal biopsies * nodes biopsies * cutaneous fat tissues biopsies * semen sample (at home)

Eligibility criteria:
inclusion criteria: * male hiv-1 infected subjects * age \> or = 18 years old * currently receiving as first line a stable arv regimen containing bictegravir (at 50 mg once a day) and two nucleoside reverse transcriptase inhibitors, tenofovir alafenamide/emtricitabine (biktarvy) * hiv rna \<50 cp/ml, undetectable 6 months after treatment initiation and confirmed and 12 months after treatment initiation. * normal laboratory value of tp and tca and platelets numbers at screening * written and informed consent signed by the person and the investigator (no later than the day of pre-inclusion and prior to any examination realized in the frame of the research / study / trial) (article l1122-1-1 of the public health code) * person affiliated or beneficiary of a social security scheme (article l1121-11 of the public health code) (state medical aid or ame is not a social security scheme) exclusion criteria: * single hiv-2 infection * biopsies contraindication, taking anticoagulant and antiplatelet drugs are not allowed * haemophilia * symptomatic sexually transmitted infection * being under guardianship or trusteeship mandate for future protection * participate to another research involving human person, categories 1 or 2, * associated treatments : carbamazepine, oxcarbazepine, phenytoin, phenobarbital, rifampicin, st. john's wort.

Keywords: viral cartography viral reservoir antiretroviral treatments diffusion
cilostazol stroke prevention study : a placebo-controlled double-blind trial for secondary prevention of cerebral infarction.

Conditions: Cerebral Infarction

Summary: the multi-center, double-blind, placebo-controlled, randomized, group-comparison study was designated to assess the long-term safety and efficacy of the antiplatelet drug cilostazol in preventing the recurrence of cerebral infarction in patients who had suffered a cerebral infarction 1 to 6 months prior to entering the trial.


Eligibility criteria:
inclusion criteria: 1. prior cerebral infarction onset at 1 to 6 months before randomization 2. ct or mri detection of responsible site 3. without serious complications (malignant tumor, liver cirrhosis, renal failure, or heart failure) exclusion criteria: 1. history of intracranial hemorrhage 2. possibility of cardiogenic cerebral embolism in the past or future all patients with any of the following complications were excluded: mitral valve stenosis, prosthetic valve, endocarditis, myocardial infarction within 6 weeks after onset, ventricular aneurysm, intraventricular or intraatrial blood clots, mitral valve prolapsed (age under 45 years old, lacking other causes for cerebral embolism induction), atrial fibrillation, sick sinus syndrome, idiopathic cardiomyopathy 3. severe cerebral deficits rendering the patient bed-ridden, totally dependent, or demented 4. contraindications to the study drug hemostatic disorders or systemic bleeding pregnant or possibly pregnant women, or nursing mothers 5. requirement for nonstudy antiplatelet drugs, anticoagulant drugs, or fibrinolytic drugs for another disease
feasibility of nutritional telemonitoring in elderly home care patients

Conditions: Undernutrition; Aging

Summary: an optimal nutritional status is essential for healthy ageing. telemonitoring might contribute to maintaining or improving nutritional status in elderly people.the objectives of this pilot study are to test the feasibility, acceptability and implementation fidelity of telemonitoring of nutritional parameters in community-dwelling older adults; to test the study procedures for effect evaluation; and to determine the likelihood of achieving desired impact on the primary and secondary outcomes.


Eligibility criteria:
inclusion criteria: having a care referral for at least one of the following types of care: * domestic care * personal care * nursing care * individual or group support exclusion criteria: * severe cognitive impairment (mini mental state examination (mmse) \< 20) * receiving terminal care * expected length of receiving home care \< three months * not having a television at home * clients with a visual impairment (not able to watch the television screen) * clients with a physical impairment in such a way, that they are not able to use the telemonitoring system * clients with nursing home care

Keywords: ehealth older adults undernutrition feasibility study
open label controlled trial of eculizumab in adult patients with plasma therapy-resistant ahus

Conditions: Atypical Hemolytic Uremic Syndrome

Summary: the purpose of this study is to determine whether eculizumab is safe and effective in the treatment of adult patients with plasma therapy-resistant atypical hemolytic-uremic syndrome (ahus).


Eligibility criteria:
exclusion criteria: 1. ttp, (defined as adamts-13 activity \<5%) from an historical observation (prior to initiation of plasma therapy) or as tested at the screening visit by the central laboratory 2. malignancy within 5 years of screening 3. typical hus (shiga toxin +) 4. known hiv infection 5. identified drug exposure-related hus. 6. infection-related hus 7. hus related to bone marrow transplant 8. hus related to vitamin b12 deficiency 9. renal function status requiring chronic dialysis 10. patients with a confirmed diagnosis of sepsis 11. presence or suspicion of active and untreated systemic bacterial infection that, in the opinion of the investigator confounds an accurate diagnosis of ahus or impedes the ability to manage the ahus disease 12. pregnancy or lactation 13. unresolved meningococcal disease 14. known systemic lupus erythematosus (sle) or antiphospholipid antibody positivity or syndrome 15. any medical or psychological condition that, in the opinion of the investigator, could increase the patient's risk by participating in the study or confound the outcome of the study 16. patients who have received previous treatment with eculizumab 17. patients receiving ivig within 8 weeks or rituximab therapy within 12 weeks of screening. 18. patients receiving other immunosuppressive therapies such as steroids, mtor inhibitors or tacrolimus are excluded unless: \[1\] part of an established post-transplant anti-rejection regime, \[2\] patient has confirmed anti-cfh antibody requiring immunosuppressive therapy, and \[3\] dose of such medications have been unchanged for at least 4 weeks prior to the screening period or \[4\] patient is experiencing an acute ahus relapse immediately after transplant 19. patients receiving erythrocyte stimulating agents (esas) unless already on a stable dose for at least 4 weeks prior to the screening period, or a washout period of at least 2 weeks from the last dose of esa therapy. 20. participation in any other investigational drug trial or exposure to other investigational agent, device, or procedures beginning 4 weeks prior to screening and throughout the entire trial. 21. hypersensitivity to eculizumab, to murine proteins or to one of the excipients

Keywords: ahus
bringing south african men into hiv counseling and testing and care

Conditions: Human Immunodeficiency Virus

Summary: this clinical trial seeks to determine if male-centered recruitment increases men's testing for hiv and whether or not individualized introduction to clinics increases male engagement in treatment for hiv. the study is being conducted in rural kwazulu natal.

this study combines structural and individual level interventions for hiv and integrates the two to address the study's objective of identifying south african men in kwazulu natal with hiv and maintaining those diagnosed with hiv in care to the point of viral suppression. the cluster-randomized design will randomize 8 communities to intervention or control to test the hypothesis whether male-centered mobilization and testing increases the population-level percentage of men who have been tested within the past 12 months by more than 10 absolute percentage points. the individually randomized design will test whether individualized case management will effectively link hiv-positive men to treatment to the point of viral suppression. the study will also examine the incremental cost-effectiveness of the interventions.

Eligibility criteria:
inclusion criteria: * men residing in the target communities exclusion criteria: * men outside of the target communities * men who report being tested and hiv+

Keywords: prevention testing and diagnosis treatment
a double-blind, placebo-controlled study of galantamine to improve cognitive dysfunction in bipolar disorder

Conditions: Bipolar Disorder

Summary: the purpose of this study is to determine if galantamine augmentaion improves cognition in euthymic bipolar patients. in addition, the effect of galantamine on clinical measures of functioning and psychopathology will also be assessed.

the study length is 12 to 24 weeks depending on whether patients enter the crossover. study also involves 3 neuropsychology testings.

Eligibility criteria:
inclusion criteria: * age 18-60; dsm-iv diagnosis of bipolar disorder, any subtype; baseline mini mental status exam above 20; mrs \< 16; madrs \< 16 exclusion criteria: * current substance dependence; serious unstable medical conditions; active suicidal ideation; current dsm-iv for a major mood episodes; history of copd, epilepsy, cardiac arrhythmia, and peptic ulcer disease; meet dsm-iv criteria for dementia
chronic pain following thoracic surgery

Conditions: Pain, Postoperative

Summary: pain that persists after the healing of a surgical wound has previously been described as an important, but often unrecognized clinical problem. persistent postsurgical (chronic postoperative pain) is the consequence of either ongoing inflammation or more common neuropathic pain as a result of surgical damage to peripheral nerves. previous studies have shown that chronic pain is a frequent and serious complication following thoracic surgery. however, the prevalence of chronic pain following both thoracoscopy and anterior thoracotomy in patients with pulmonary malignancies is poorly characterized and the impact of this pain on patients' lives remains unclear. thus, this study aims to investigate the prevalence of chronic pain following thoracoscopy or anterior thoracotomy, and the severity and impact of persistent post-surgical pain on daily life. this study is working with several hypotheses: 1.) persistent postsurgical pain following lung cancer surgery is predominantly of neuropathic nature and the presence of neuropathic symptoms increases the severity of postsurgical pain and reduces the patient's quality of life, 2.) the prevalence of chronic pain is reduced over time, and 3.) less invasive thoracic surgical interventions reduces the risk of the development of chronic pain.


Eligibility criteria:
inclusion criteria: * patients who previously underwent thoracic surgery with lung resection from january 2000 to december 2009 exclusion criteria: * death

Keywords: thoracotomy thoracic surgery thoracic surgical procedures thoracic surgery, video-assisted lung neoplasms thoracic nerves
phase ii study of albumin bound paclitaxel with 5-fu and cf as second line in taxanes naive advanced gastric cancer

Conditions: Gastric Caner

Summary: the purpose of this study is to evaluate the effectiveness and safety of albumin bound paclitaxel plus 5-fu and as second-line therapy in the treatment of taxanes naive patients with advanced gastric cancer.


Eligibility criteria:
inclusion criteria: * histologically confirmed adenocarcinoma of the stomach with inoperable locally advanced or recurrent and/or metastatic disease. * male or female. * age 18 -75. * previous one line of non-taxane chemotherapy for advanced/metastatic disease. * measurable disease, according to the response evaluation criteria in solid tumours(recist) * ecog performance status 0, 1 or 2 * haematological, biochemical and organ function: neutrophil count \>2.0 × 10 9/l, platelet count \> 100 ×10 9/l. serum bilirubin\ 5 × uln in patients with liver metastases,creatinine clearance \> 60 ml/min. * signed informed consent. exclusion criteria: * no prior chemotherapy for gastric cancer. * received any investigational drug treatment within 30 days of start of study treatment. * patients with active gastrointestinal bleeding. * neurological toxicity ≥ grade 2 nci-ctcae. * other malignancy within the last 5 years, except for carcinoma in situ of the cervix, or basal cell carcinoma. * history or clinical evidence of brain metastases. * serious uncontrolled systemic intercurrent illness, e.g. infections or poorly controlled diabetes. * pregnancy women. * subjects with reproductive potential not willing to use an effective method of contraception. * patients with known active infection with hiv. * known hypersensitivity to any of the study drugs

Keywords: gastric caner albumin bound paclitaxel 5-fu/cf taxanes naive
real word evidence with 1l polyethylene glycol (peg)+ ascorbic acid in iberia

Conditions: Colon Cancer; Colon Disease; Colon Cleansing

Summary: a retrospective study to evaluate the effectiveness and safety of 1l polyethylene glycol (peg)+ ascorbic acid given for bowel preparation before colonoscopy.

observational, retrospective, and multicenter study based on the review of the existing medical records of patients followed on an outpatient basis (computerized databases and dissociated data). the design implies the incorporation of existing anonymized data by the hospital centers without leaving any record of the code assigned to each patient. the design, therefore, avoids the possible risk of the dissemination of the personal data of patients.

Eligibility criteria:
inclusion criteria: * male and female outpatients aged: ≥18 years undergoing a screening, surveillance, or diagnostic colonoscopy between june 1, 2019, to september 1, 2021 * who have used ner1006 in the preparation of the colonoscopy either in split doses or same day. exclusion criteria: * history of colorectal cancer o colectomy before the first colonoscopy * impossibility to obtain the required mandatory data
efficacy and safety of pregabalin vs placebo for generalized anxiety disorder (gad) symptoms in subjects discontinuing benzodiazepine treatment and remaining 6 weeks on study medication, free from benzodiazepine use.

Conditions: Generalized Anxiety Disorder

Summary: gad subjects maintained on a stable dose of alprazolam for at least four weeks who meet eligibility criteria will be randomized to receive pregabalin vs matching placebo while simultaneously tapering off of alprazolam over 6 weeks. subjects return weekly for assessment of safety/tolerability of pregabalin vs placebo as well as for assessment of anxiety and benzodiazepine withdrawal symptoms. subjects successfully able to discontinue alprazolam, will continue 6 weeks of treatment with pregabalin vs placebo (free of benzodiazepine use). the efficacy and safety of pregabalin vs placebo for anxiety symptoms and ability to discontinue/remain free of alprazolam will be compared among pregabalin and placebo treated groups. hypothesis is that a greater proportion of subjects will be successful in discontinuing and remaining free from benzodiazepines who were treated with pregabalin as compared to subjects treated with placebo.


Eligibility criteria:
inclusion criteria: * provide written informed consent * 18-65 years old * male and female * a primary lifetime diagnosis of dsm-iv-tr (2000) gad (diagnostic and statistical manual of mental disorders, fourth edition) exclusion criteria: * pregnant or lactating women * history of non-response to alprazolam, other benzodiazepines, gabapentin or pregabalin given for the treatment of anxiety as indicated by a (screening or baseline) hamilton anxiety scale (ham-a) score \> 18