Kornimate/medical-research-clean huggingface dataset:
comparison of billroth-i and roux-en-y reconstruction after distal subtotal gastrectomy

Conditions: Gastrectomy

Summary: the purpose of this trial is to compare the degree of reflux, operative outcomes and quality of life between roux en y and billroth-i reconstructions after distal subtotal gastrectomy for gastric cancer

most common procedure for the resection of gastric cancers located in middle or lower stomach is distal subtotal gastrectomy. however, the optimal reconstruction procedure after that has still not to be established. although b-i reconstruction is most common method due to the safety and simplicity, the duodenal fluid may reflux into the remnant stomach which may contribute to the mucosal injury to remnant stomach and esophagus. roux en y reconstruction may reduce the reflux to remnant stomach due to the length of roux en y limb, although it is more complicated procedure. therefore, we plan to collect 120 patients to compare the degree of reflux between roux en y and billroth-i reconstructions after distal subtotal gastrectomy for gastric cancer. in addition, we compare the surgical outcome and quality of life between two groups.

Eligibility criteria:
inclusion criteria: * patients diagnosed with adenocarcinoma at the endoscopic biopsy * patients who are possible to be performed curative resection in imaging study * patients with tumor which not involved in pylorus and are located in mid or distal portion of the stomach * patients with informed consent * patients with three or less american society anesthesiology score 3 exclusion criteria: * patients who are or become pregnant * patients with uncontrolled disease * patient s with synchronous other malignancy * patients participated in other clinical trial

Keywords: distal gastrectomy reconstruction reflux subtotal gastrectomy
stress induced by the covid-19 pandemic and nonconfinement: study of anxiety factors and potential effects on immunity.

Conditions: Stress Disorder

Summary: the aim of this project is to evaluate the impact of pandemic and nonconfinement related to anxiety and eventual immune diseases with several standardized questionnaires : implant stability quotient (isq) , generalized anxiety disorder-7 (gad-7), patient health questionnaire -9 (phq-9), post traumatic stress disorder-8 (ptsd-8), and experiences in close relationship scale (ecrs).

the covid-19 pandemic and prevention strategise have strongly impacted family lives, social lives, professional lives, and income; resulting in increased reporting of stress and anxiety within patients. this risk of infection 'post-confinement' is an additional source of stress for people returning to their professional and social lives. there are evidence showing a relationship between stress, immunity and the prognosis of several infections and inflammatory diseases. the covid-19 pandemic and prevention strategise have strongly impacted family lives and induced a high level of anxiety and other types of stress. this risk of infection 'post-confinement' is an additional source of stress for people returning to their professional and social life. there are evidences showing a relationship between stress, immunity and the prognosis of several infections and inflammatory diseases. the aim of this project is to launch an online survey that measures population stress felt during the pandemic and post-confinement time and possible effects on eventual immune mediated disorders (allergies, auto-immunity..) through the report of new events or flares. the stress will first be measured on standardized anxiety gad-7scale but also on more parameters (isq, phq-9, ptsd-8, and ecr-s). socio-economic and environmental parameters will be recorded. level of anxiety and other stress parameters as well as occurrence of inflammatory events will be measured according to the calendar and confinement /post confinement timing. risk factors will be looked for, by multi parametric data analysis. the survey has been built in a user-friendly, accessible way so the investigators can expect a high number of participants (at least 400), especially as people are highly concerned by the situation and will be motivated to take part.

Eligibility criteria:
inclusion criteria: * adult volunteer who agreed to answer the questionnaires * age ≥ 18 years old * adult affiliated or having a duty to a social security scheme exclusion criteria: * children under 18 years old * inability to understand information letter, consent, or to use online questionnaire

Keywords: covid-19 stress effects on immunity anxiety
postoperative pain after medical abortion under local anesthesia : comparison of several analgesic regimen

Conditions: Abortion, Induced

Summary: * to compare postoperative analgesia by paracetamol 1gr or ketoprofen 100 mg or the combination of these two analgesics * each treatment beeing allocated by randomization

* 240 pregnant women who undewent a medical abortion by aspiration, under local anesthesia, (day case surgery) were enrolled after informed consent and signed approval * according to randomization, they received one hour before medical abortion procedure performed under local anesthesia of the cervix, one of these three diffrente analgesics : * paracetamol 1 gr * ketoprofen 100 mg * the association of both postprocedure pain was recorded, by nurse, using a visual analog scale (vas), 7 times before and after the procedure, until the discharge of the patient. * if vas was above 40 on two consecutive measurements a morphine injection was given. * the number and total amount of morphine was recorded. * satisfaction was recorded within the 3 postoperative day by a telephone inquiry.

Eligibility criteria:
inclusion criteria: * pregnant women * medical abortion performed in day case surgery under local anesthesia * informed written consent exclusion criteria: * under 18 year old

Keywords: medical abortion analgesia
proteomics and genomics combined with ct to predict cvd

Conditions: Coronary Artery Disease Progression

Summary: this study evaluates plaque progression and characteristics in patients with coronary atherosclerosis.


Eligibility criteria:
inclusion criteria: * adult patients between 50 and 75 years old * subjects at intermediate to high risk for ascvd * asymptomatic patients without cardiac chest pain * evidence of atherosclerosis on baseline ccta exclusion criteria: * renal insufficiency, defined as egfr \< 30 ml/min * history of cardiovascular events (myocardial infarction, peripheral artery disease and ischemic stroke) * use of lipid lowering therapy other than statin, ezetimibe or bempedoic acid monotherapy * change in lipid lowering therapy in the last 6 months * use of more than two antihypertensive agents * no coronary atherosclerosis at baseline imaging * active malignancy requiring treatment * atrial fibrillation * any other treatment or clinically relevant condition that could interfere with the conduct or interpretation of the study in the opinion of the investigator * inability or unwillingness to comply with the protocol requirements, or deemed by investigator to be unfit for the study.
evaluation of work productivity and activities of the fibromyalgia patients' relatives

Conditions: Fibromyalgia; Work Productivity; Quality of Life; Pain, Chronic

Summary: patients suffering from fibromyalgia (fm) are challenged by symptoms such as chronic pain, fatigue, sleep disturbance and emotional distress. patients diagnosed with fibromyalgia can also negatively affect the relatives they live with due to their existing complaints. it is possible that their relatives accompanying them may lose their workforce due to untreated pain complaints and frequent hospital admissions. the main purpose of our study is to examine whether there is any impact on the working life of the people they live with and whether there is a decrease in their work productivity.

this cross-sectional study will evaluate fm patients and their relatives, who are in paid full- or part time employment at the time of the assessment. the study protocol doesn't require any medical intervention. fibromyalgia severity will be assessed with the fibromyalgia impact questionnaire (fiq). evaluation of patient relatives' work productivity and activities will be made with the work productivity and activity impairment questionnaire: general health (wpai:gh). analyzes will be completed with a group of healthy controls in the study.

Eligibility criteria:
inclusion criteria: study group: must live together with a patient diagnosed with fm 18-65 years old must work in a full-time/part-time job control group: must live with a healthy relative 18-65 years old must work in a full-time/part-time job exclusion criteria: must live alone not having a full-time/part-time job

Keywords: fibromyalgia work productivity and activity impairment quality of life
enhanced recovery after surgery protocal versus traditional care in laparoscopic hepatectomy

Conditions: Liver Diseases

Summary: the purpose of this study is to investigate the clinical value of enhanced recovery after surgery protocal in laparoscopic hepatectomy by assessing its outcomes and hospital stay days comparing with traditional care .

the eras programs has been proved to be a useful solutions in patients undergoing colorectal surgery in terms of significantly reduced postoperative complications and shorter length of hospital stay, compared to the patients of conventional treatment. but few studies reported about the eras programs in the laparoscopic hepatectomy. the purpose of this study is to investigate the clinical value of enhanced recovery after surgery protocal in laparoscopic hepatectomy by assessing its outcomes and hospital stay days comparing with traditional care .

Eligibility criteria:
inclusion criteria: * if patients were diagnosed with tumors 1. located at segment ⅱ、ⅲ、ⅳb、ⅴ or ⅵ 2. the tumor location and size do not affect the dissection of hepatic hilar region 3. tumor size less than 10cm 4. without portal vein tumor thrombus 5. without intrahepatic or distant metastasis * partial resection or half liver resection * willingness to participate in the study * able to understand the nature of the study and what will be required of them * body mass index of between 18 and 35 * child-pugh classification of a to b * american society of anesthesiologists (asa) grading of i to iii exclusion criteria: * pregnant or lactating women * unwillingness to participate * inability to give written informed consent * child-pugh classification of c * asa grading of iv to v * tumor invasion of the inferior vena cava or confluence part of hepatic vein * decompensated liver cirrhosis

Keywords: enhanced recovery after surgery protocal laparoscopic hepatectomy
exploratory study of danicamtiv in patients with primary dilated cardiomyopathy (dcm) due to genetic variants or other causalities

Conditions: Primary Familial Dilated Cardiomyopathy

Summary: the purpose of this phase 2a study is to establish safety and preliminary efficacy of treatment with danicamtiv in patients with primary dilated cardiomyopathy (dcm) due to myh7 or ttn variants or other causalities.


Eligibility criteria:
inclusion criteria: * for myh7 and ttn cohorts, must have diagnosis of primary dcm (dilated cardiomyopathy), clinically stable and due to probably disease-causing variant of myh7 or ttn * has adequate acoustic windows for echocardiography * maximum of 3 family members with same variant can be enrolled * for the cohort of primary dcm due to causalities other than myh7 and ttn, participant must have diagnosis of primary dcm with a cause not related to myh7 or ttn variants exclusion criteria: * significant structural cardiac abnormalities including valvar dysfunction on screening transthoracic echo(s) * routinely scheduled outpatient intravenous (iv) infusions for heart failure (e.g., inotropes, afterload reduction, or diuretics) * presence of protocol specified laboratory abnormalities at screening * recent acute coronary syndrome or angina pectoris (\<90 days) * recent hospitalization for heart failure (\<90 days)

Keywords: primary dilated cardiomyopathy (dcm) familial dilated cardiomyopathy (dcm) myosin heavy chain 7 (myh7) titin (ttn) myk-491 danicamtiv
support by singing sessions on physical and moral pain : assessment of its effectiveness in alzheimer's disease

Conditions: Alzheimer's Disease

Summary: alzheimer disease (ad), characterized by cognitive and psycho-behavioral troubles, concerns essentially 65 years old and older patients. antalgic and psychotropic treatments have adverse effects in old people, and have to be used carefully. to improve the pain support and limit the drug consumption, it is possible to perform therapies without drugs. among them, musical intervention represents an interesting complementary support, to deal with physical and moral pain in ad.

alzheimer disease (ad), characterized by cognitive and psycho-behavioral troubles, concerns essentially 65 years old and older patients. at this age, comorbidities are frequent and numerous, and often linked to pain. the prevalence is comprised between 40 and 85% according to different studies. antalgic and psychotropic treatments have adverse effects in old people, and have to be used carefully. to improve the pain support and limit the drug consumption, it is possible to perform therapies without drugs. among them, musical intervention represents an interesting complementary support, to deal with physical and moral pain in ad. the primary outcome is to evaluate the singing support on physical pain, by comparison with a control activity : "painting session".

Eligibility criteria:
inclusion criteria: * patients 60 years old and older, fulfilling the diagnostic criteria for alzheimer's disease to a mild dementia stage, or mild cognitive impairment * delay of at least one month between the diagnosis and the early work sessions * if use of psychotropic drugs, they must be stabilized for 3 month * if analgesics consumption level 2 or 3 they must be stabilized for 1 month * with a score greater than or equal to 22 on the simplified visual scale (evs) pain. * visual capabilities , auditory and oral or written expression in french language sufficient for conducting clinical and neuropsychological evaluations; * mmse \> 20 * patient affiliated or entitled to a social security scheme exclusion criteria: * patient with a different etiology of cognitive disorder that of alzheimer's disease * patients with severe disease, progressive or unstable nature which may interfere with the evaluation variables * patient with blindness or deafness could compromise its assessment * patient under guardianship
folfiri as second line chemotherapy for metastatic esophageal carcinoma

Conditions: Advanced Esophageal Carcinoma

Summary: this phase ⅱ study was designed to evaluate the efficacy and safety of folfiri as second-line treatment for metastatic esophageal carcinoma.

although there are no standard second-line treatment for metastatic esophageal carcinoma, some studies have showed that irinotecan, fluorouracil may be effective in treating patients with metastatic esophageal carcinoma after failure of first-line treatment. since irinotecan, fluorouracil, and leucovorin work in different ways to stop the growth of tumor. giving more than one drug may be more effective. in this phase ⅱ trial, the investigator would like to observe the efficacy and safety of folfiri(irinotecan/5-fu/leucovorin ) as second-line treatment for metastatic esophageal carcinoma.

Eligibility criteria:
inclusion criteria: * patients have provided a signed informed consent form * karnofsky score ≥70 * age: 18-75 years old * histologically confirmed diagnosis of advanced esophageal carcinoma * patients have received and progressed on first-line treatment, and not received cpt-11 or fluoropyrimidine based palliative chemotherapy * measurable disease in at least 1 diameter by ct scan or mri as per recist 1.1 criteria * life expectancy ≥ 3 months * patient has adequate bone marrow and organ function * absolute neutrophil count (anc) ≥ 1.5 x 109/l * platelets ≥ 75 x 109/l * hemoglobin ≥ 9.0 g/dl * patient has adequate liver function * ast and alt not more than 2.5 times uln (not more than 5.0 times uln if there is liver metastasis) * serum bilirubin ≤ 2 x uln * creatinine ≤ 1.5 times uln * good compliance exclusion criteria: * pregnant or lactating women * brain metastasis or only with bone metastasis. * patients with severe infection or active peptic ulcer which need treatment * severe systemic disease out of control such as unstable or uncompensated respiratory, cardiac, liver, renal diseases * patient has a concurrent malignancy or has a malignancy within 5 years of study enrollment, (with the exception of non-melanoma skin cancer or cervical carcinoma in situ * psychiatric illness that would prevent the patient from giving informed consent * patient is concurrently using other approved or investigational antineoplastic agent
comparison of a double-layered technique with the buccal sliding flap for closure of oroantral communication

Conditions: Oroantral Fistula

Summary: the aim of this study is to compare the clinical results of combining a pedicle connective palatal flap with a trapezoid buccal flap with the standard buccal flap alone in the closure of oro-antral fistula (oaf), and the buccal flap combined with leukocyte and platelet rich fibrin.


Eligibility criteria:
inclusion criteria: eligible population among those older than 18 y.o, systemically healthy, with a diagnosis of oac (oroantral communication), or with a strong pre-extractive radiographic suspicion of potential oac, and associated symptoms (varying among cheek pain with nasal obstruction, purulent rhinorrhea, foul odor, foul taste, headaches, anterior maxillary tenderness, and postnasal drip) . exclusion criteria: i) received antibiotic therapy in the last 3 months ii) requiring anticoagulation therapy iii) had systemic diseases that could interfere with oral tissue healing process/bleeding iv) were using bisphosfonates v) were pregnant vi) had mental/physical disabilities vii) underwent radiation treatment to the head or neck region.
patient-controlled sedation in port implantation (pacspi-1)

Conditions: Pain; Patient Satisfaction

Summary: the purpose of this prospective, observational study is to assess the feasibility of patient-controlled sedation (pcs) for implantation of subcutaneous venous ports (svp).

the main objective of this trial is to study the feasibility of (pcs) with propofol and alfentanil during svp implantation. participants included in the study are able to administer a combination of propofol and alfentanil using a patient-controlled sedation pump. this allows the patient to self-control their sedation/analgesia during svp implantation. the pump enables the patient via a hand-held button to trigger the release of a single bolus. a bolus of 0.5ml programmed into the pump contains a combination of 4.5mg propofol and 25µg alfentanil and is administered under a 7 second period resulting in a maximal amount of 8 bolus doses per minute. each svp implantation procedure is separated into four time points at which sedation scores are recorded. patients are monitored by anaesthesia staff and svp implantation is performed by an anaesthesiologist according to hospital protocol. participants are asked to fill in a written questionnaire to indicate pain score and satisfaction with the procedure when ready for discharge. adverse events, time consumption and operators satisfaction with implantation conditions are recorded periprocedural. the result of this trial will provide guidance for a larger randomized trial (pacspi-2) comparing several clinically relevant aspects of the use of pcs and local anesthesia (la) versus la alone during svp implantation.

Eligibility criteria:
inclusion criteria: • adult patients (≥18 years) scheduled for svp implantation at ryhov county hospital. exclusion criteria: * inability to operate the pcs apparatus, * inability to communicate in scandinavian languages. * patients who require general anaesthesia or patients eligible for local anaesthesia only (i.e. severe sleep apnea). * propofol or alfentanil allergy. * intake of food (or clear fluids) within six (or two) hours prior to the procedure. * failure to achieve peripheral vascular access. * pregnancy

Keywords: patient-controlled sedation totally implantable venous access devices subcutaneous implanted venous port local anesthesia propofol alfentanil indwelling catheter
prediction and prevention of asymptomatic cardiovascular insult in type 1 diabetic children: comparative effectiveness of cardioprotective drugs

Conditions: Diabetes Mellitus, Type 1

Summary: diabetic cardiomyopathy (dcm) is a distinct clinical entity of diabetic heart muscle that describes diabetes associated changes in the structure and function of the myocardium in the absence of coronary artery disease, hypertension, and valvular disease. oxidative stress plays a critical role in dcm development. dcm can be diagnosed using the novel methods of echocardiography (tissue doppler imaging, speckling tracking techniques and more recent real time 4d echocardiography). there is a possible cardioprotective effect of statins, captopril and l-carnitine in type 1 diabetic children and adolescents.


Eligibility criteria:
inclusion criteria: * children and adolescent suffering from type 1 diabetes mellitus, for at least 3 years from the onset of the disease. exclusion criteria: * children with congenital heart diseases. * children with acquired cardiac diseases. * children with other systemic diseases. * symptomatic diabetic cardiomyopathy.
effect of naproxen, aspirin, celecoxib, or clopidogrel on the healing of stomach and intestinal ulcers

Conditions: Gastroduodenal Ulcer

Summary: gastroduodenal ulcers are extremely common in the community today. though much has been written and observed concerning how ulcers form, not much has been described in the human model concerning how these ulcers heal. as numerous patients already suffer from gastrointestinal ulcers, further clarification of ulcer healing would be valuable in the treatment and management of these patients. the goal of this study is to investigate the effects of naproxen, aspirin, celecoxib, and clopidogrel on biopsy-induced gastroduodenal lesions in order to elucidate the mechanisms of ulcer healing. this single site, single-blind, randomized, placebo-controlled, one-week prospective study will examine ulcer healing through endoscopic, immunohistologic, and molecular pcr modalities.

in order to assess the extent of healing of the biopsy sites, a 12-point scale was developed and validated. after all of the procedures were complete, this scale was used to measure the effects of the study drugs on the healing of the biopsy-induced ulcers.

Eligibility criteria:
inclusion criteria: * signed informed consent * age 18-75 * use of appropriate form of birth control for women of childbearing potential. exclusion criteria: * h pylori infection * use of nsaids within 2 weeks prior to start of enrollment * use of antacids or h-2 blockers within 2 weeks of enrollment * use of ppis within 30 days of enrollment * corticosteroid use within 60 days of enrollment * history of a previous ulcer * diagnosis of a bleeding diathesis or use of warfarin within 60 days of enrollment * use of cigarettes within 6 months of enrollment * consumption of \>3 alcoholic beverages per day * hypersensitivity or allergy to nsaids, clopidogrel, or corn starch, or any contraindications to ingesting those substances * the presence of an ulcer at a baseline endoscopy * endoscopically severe gastritis or duodenitis baseline endoscopy * moderate or severe inflammation located within the duodenal bulb or within 2cm of the pyloric channel at a baseline endoscopy * any gastroduodenal tumor.

Keywords: nsaid ulcer gastroduodenal ulcer naproxen aspirin asa celecoxib clopidogrel healing cyclooxygenase 2 inhibitors anti-inflammatory agents, non-steroidal platelet aggregation inhibitors wound healing