Kornimate/medical-research-clean huggingface dataset:
exploratory study of toumai endoscopic surgery system for remote gastrectomy

Conditions: Gastric Cancer

Summary: this clinical study was a prospective, single-center, single-arm exploratory study. subjects who meet the inclusion criteria will be enrolled in this study, where surgeons will perform 5g remote gastrectomy on subjects using the toumai endoscopic surgery system, and explore and evaluate the safety and efficacy of this clinical application.


Eligibility criteria:
inclusion criteria: 1. 18 years old ≤ actual age ≤80 years old. 2. patients requiring gastrointestinal endoscopic surgery. 3. willing to cooperate with and complete the study follow-up and related examinations. 4. voluntarily participate in the study and sign the informed consent in person. exclusion criteria: 1. have serious cardiovascular or circulatory disease and cannot tolerate surgery. 2. participated in other clinical trials within the last 3 months. 3. inability to understand trial requirements, or inability to complete the study follow-up plan. 4. researchers believe that there are other circumstances that are not suitable for inclusion.
dose-finding study comparing the safety and efficacy of latanoprost to a novel treatment for glaucoma

Conditions: Primary Open Angle Glaucoma; Ocular Hypertension; Pigmentary Glaucoma; Pseudoexfoliative Glaucoma

Summary: this study will evaluate the safety and efficacy of pf 03187207.


Eligibility criteria:
inclusion criteria: -diagnosis of primary open angle glaucoma (including pigmentary or pseudoexfoliative) or ocular hypertension in one or both eyes exclusion criteria: -closed or barely open anterior chamber angle or a history of acute angle closure in either eye
efficacy and safety of alogliptin used in combination with sulfonylurea in participants with type 2 diabetes in japan

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of this study was evaluate the efficacy and safety of alogliptin, once daily (qd) combined with an sulfonylurea taken qd or twice daily (bid) in type 2 diabetic patients with uncontrolled blood glucose.

both insulin hyposecretion and insulin-resistance are considered to be involved in the development of type 2 diabetes mellitus. takeda is developing syr-322 (alogliptin) for the improvement of glycemic control in patients with type 2 diabetes mellitus. alogliptin is an inhibitor of the dipeptidyl peptidase iv (dpp-iv) enzyme. dpp-iv is thought to be primarily responsible for the degradation of 2 peptide hormones released in response to nutrient ingestion. it is expected that inhibition of dpp-iv will improve glycemic control in patients with type 2 diabetes. the present study was planned to evaluate the efficacy and safety of alogliptin as an add-on to sulfonylurea in type 2 diabetic patients who had uncontrolled blood glucose despite treatment with an sulfonylurea as well as diet and exercise therapies.

Eligibility criteria:
inclusion criteria: 1. had been taking a sulfonylurea for at least 4 weeks prior to the initiation of the observation period (week -12). 2. had been taking glimepiride at a stable dose regimen (1, 2, 3 or 4 mg/day, once or twice daily in the morning or in the morning and evening, before or after meal) for at least 12 weeks prior to the initiation of the treatment period (week 0). 3. had glycosylated hemoglobin (hba1c) of 7.0% or more and below 10.0% at 8 weeks after the initiation of the observation period (week -4). 4. had an hba1c difference between 4 weeks after the initiation of the observation period (week -8) and 8 weeks after the initiation of the observation period (week -4) being within 10.0%\* of the value at 4 weeks after the initiation of the observation period (week -8) (\*rounded off to the first decimal place). 5. was receiving specific diet and exercise (if any) therapies during the observation period. exclusion criteria: 1. had taken other diabetic medications than glimepiride within 12 weeks before the initiation of the treatment period (week 0).

Keywords: diabetes mellitus - type 2 diabetes mellitus drug therapy
a comparative study of clinical, endoscopic and histopathological features of colitis in children

Conditions: Role of Ileoscopy in Diagnosis of Colitis

Summary: a comparative study of clinical, endoscopic and histopathological features of colitis in children

to find out the role of ileoscopy in diagnosis of colitis and compare clinical , endoscopic and histopathological manifestations of colitis

Eligibility criteria:
inclusion criteria: * 1. all patients diagnosed as colitis during the study period. 2. age from 1 month to 18 years. exclusion criteria: 1. patients with lower gastrointestinal manifestations and weren't diagnosed as colitis during colonoscope. 2. patients less than one month and more than 18 years.
efficacy of polymyxin b against infections caused by extensively drug-resistant (xdr) gram-negative bacteria

Conditions: Hospital Infection

Summary: the objective of the study is to evaluate the efficacy of polymyxin b for treatment gram negative bacterial infection. the hypothesis of study is polymyxin b would be the new antibacterial agents for thai gram negative infected patients in case of desirable outcomes and minimal side effects.

* investigator is notified by doctors who take care of gram negative infected patients. * investigator inform patient or their relatives about all topics in project, eligible criteria, method, material and monitoring treatment. * after patient or their relatives are appreciated to join this project, investigator collect data in case record form;electronics form, then implement the drug. * duration of treatment is determined by site and severity of infection, approximately 7-14 days. * sample size calculation, by prevalence formula, we estimate the mortality rate about 50 %, deviation 10 %,and 2-sided 95% confidence interval, therefore,97 persons * we estimate gather data about 100 persons. * statistical descriptive analysis for descriptive data. * during the study is performing, all unexpected adverse event definitely report to siriraj institutional review board immediately, in addition to subjects or their relatives.

Eligibility criteria:
inclusion criteria: * age 18-75 year-old * the infection caused by carbapenem-resistant (cr) enterobacteriaceae, cr p.aeruginosa or cr a. baumannii which susceptible to colistin * the duration of treatment approximately between 7-14 days * kidney function, according to kidney disease improving global outcomes (kdigo) classification, should less than stage 4 and no replacement therapy in all modality. * the patients are anticipated to live more than 48 hrs after participation. * in case of colistin administration beforehand, it should not exceed 24 hrs. * all of participants should be willing to join this project. exclusion criteria: * pregnancy and lactation * end stage renal disease who take renal replacement therapy * any type of neuromuscular disease * body mass index exceed 30 * infection that require treatment more than 14 days

Keywords: polymyxin b carbapenem resistant bacteria
liquid biopsies in pediatric solid tumors

Conditions: Pediatric Solid Tumor, Unspecified, Protocol Specific

Summary: this study is being done to determine if traces of tumor can be found in the blood before, during, and after patients stop treatment. we will analyze the tumor material to see if it is similar to tumor tissue and if the tumor material in blood is helpful in monitoring the disease.

liquid biopsies, particularly those involving cell-free dna (cfdna), are a promising non-invasive, cost effective method of monitoring disease in cancer patients with solid tumors and are being increasingly employed in various adult malignancies to diagnose disease, monitor tumor response, detect relapse and learn more about tumor biology. the utility of liquid biopsies which may include isolation and analysis of tumor derived material such as dna, rna, intact cells, proteins, or exosomes from blood or other bodily fluids in pediatric solid tumors has not been established. in this study, we propose to prospectively collect serial blood samples at baseline, during therapy, end of therapy, relapse, and during follow up from patients ≥ 6 months of age with newly diagnosed or relapsed/refractory various pediatric non-cns malignant solid tumors to determine the feasibility of detecting various tumor-derived material, including exosomes, circulating tumor cells, and circulating tumor nucleic acid (ctdna and ctrna). the timing of blood sample collection will be during a routine lab draw around the time of a disease evaluation. the ctdna and ctrna as well as dna and rna extracted from tumor-derived exosomes will be quantified at each time point and the findings will be correlated with conventional methods for disease evaluation (e.g., imaging studies, histologic tumor response, or serum tumor markers) and outcome (overall survival and event-free survival).

Eligibility criteria:
inclusion criteria: * newly diagnosed, relapsed, or refractory histologically confirmed high grade bone or soft tissue sarcoma or malignant renal, thyroid, germ cell, or hepatic tumors, or * healthy individual with no history of cancer or chronic medical problems and \< 21 years of age exclusion criteria: * cns malignancies * individuals \< 6 months of age
non-interventional study to evaluate effect of zoladex in endometriosis

Conditions: Endometriosis

Summary: to observe the effect of goserelin 3,6mg sc depot injection by assessment of the mean percent reduction scores for symptoms: dysmenorrhoea, dyspareunia and pelvic pain; to observe the effect of goserelin 3,6mg sc depot injection by assessment of the mean percent reduction scores for pelvic tenderness and indurations; to observe the reduction in the proportion of patients requiring analgesics for the relief of pelvic pain for 6 months in patients treated with zoladex 3.6 mg.


Eligibility criteria:
inclusion criteria: * patients diagnosed with endometriosis that the doctors have already decided to treat with zoladex within the last month, before inclusion in this program, according to romanian approved goserelin 3,6 mg exclusion criteria: * patients who have a known hypersensitivity to goserelin (zoladex) or any of its excipients or any other gnrh analogue, pregnancy, according to romanian approved goserelin 3,6 mg smpc

Keywords: endometriosis
cryoablation of intercostal nerves for better control of postoperative pain after thoracic and thoracoabdominal open surgery

Conditions: Aneurysm

Summary: the purpose of the registry is to evaluate the peri-operative and short- term outcomes of intercostal nerves cryoablation for post-operative pain control after open thoracic and thoracoabdominal aortic aneurysms repair. the cryoablation procedure is one of the opportunities for pain control after thoracotomy. so, it is routinely performed in major several centers in aortic surgery around the world as a part of the taa and taaa procedure. the registry will include approximately 200 patients treated from january 2022 to january 2024 for thoracic or thoracoabdominal aortic aneurysm by means of open surgery and in whom intraoperative intercostal nerves cryoablation will be performed; to reach 200 patients, the enrolments can be extended until january 2027.


Eligibility criteria:
inclusion criteria: * adult patients ≥18 years * patients who will undergo taa and taaa open repair with intraoperative intercostal nerves cryoablation * subject has consented for study participation and signed the approved informed consent exclusion criteria: * patients with active systemic or cutaneous infection or inflammation * patients who are pregnant or breastfeeding * patients younger than 18 years of age * unwilling or unable to comply with the follow-up schedule * inability or refusal to give informed consent * frank rupture * previous stroke with neurological sequelae
observational study to evaluate the safety of novomix® 30 flexpen®

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this study is conducted in africa. the aim of this observational study is to evaluate the incidence of adverse events while using novomix® 30 flexpen® under normal clinical practice conditions.


Eligibility criteria:
inclusion criteria: * type 2 diabetes having failed on basal insulin with or without oad * hba1c greater than 7.0% exclusion criteria: * subjects being unlikely to comply with protocol requirements * subjects who previously enrolled in this study * subjects with hypersensitivity to biphasic insulin aspart or any of the excipients * women who are pregnant, breast feeding and women in child bearing capacity who are not using reliable contraceptive method
clinical trial comparing two health education programs for obese patients (hepo-trial)

Conditions: Obesity

Summary: clinical trial comparing two health education programs for obese patients in order to achieve a substantial and beneficial weight loss, using mediterranean diet. patients will be allocated to two groups, one will receive education in diet and lifestyle, and the other one the same plus cooking lessons. the intervention period is for 6 months with monthly visits and phone and email contacts in between. an extension observation period of two years is also planned with 6 months contacts in our clinic, also with phone and email contact available.

eligibility: obese patients attending our center. exclusion criteria: previous dietary or anti-obesity drugs treatments, previous bariatric surgery, eating disorders, desire for short-term bariatric surgery, active neoplasia, end stage kidney or liver disease, food allergies or celiac disease. sample size: a total of 260 patients (130 patients in each group) are needed for α=0.05 and 1-ß=0.8, to reach a difference of a 5% in weight loss between both groups, with a maximum of a 30% dropouts. intervention: structured health education program of mediterranean diet and lifestyle changes with cooking lessons in monthly sessions, with the aid of phone and email contacts during an induction phase of 6 months, followed by an extension period of 18 months. control: same strategy without the cooking lessons. primary outcome: weight loss in % secondary outcomes: reversal in obesity associated comorbidities and quality of life.

Eligibility criteria:
inclusion criteria: * obese patients attending our center exclusion criteria: * previous dietary or pharmacologic treatment for obesity, previous bariatric surgery, desired bariatric surgery in the short-term, eating disorders, end-stage kidney or liver disease, active neoplasia, food allergies, celiac disease.

Keywords: mediterranean diet weight loss type 2 diabetes education program cooking
stereotactic ablative radiotherapy of cardiac arrhythmias (start-ca)

Conditions: Cardiac Arrhythmia

Summary: this is a prospective, single-center, phase ii trial that will be monitoring the safety and efficacy of using stereotactic ablative radiotherapy (sbrt) to treat patients with a medical condition affecting heart rate and rhythm (refractory arrhythmias) within the university health network (princess margaret cancer centre and toronto general hospital). the primary objective will be to prospectively monitor patient cardiac outcomes following sbrt.


Eligibility criteria:
inclusion criteria: * patients with heart rate and rhythm condition (arrhythmia) who have failed standard of care treatment with medication or at least one prior invasive catheter ablation procedure. * patients deemed medically fit to receive stereotactic ablative radiotherapy as determined by their radiation oncologist. exclusion criteria: * patients who have previously received high dose radiotherapy to the target area and cannot safely receive further treatment or are unable to receive radiotherapy due to other contraindications.
study of the effectiveness of specific training of health professionals on adherence in bipolar disorder

Conditions: Bipolar Disorders

Summary: bipolar disorders are common psychiatric disorders characterized by severe and recurrent symptomatic periods (major depressive episode, mania, hypomania) and interictal periods characterized by persistent residual symptoms, impaired functioning and quality of life. in addition, the prognosis of bipolar disorder is aggravated by an increased risk of suicide and a high frequency of somatic comorbidities. poor adherence is one of the major factors influencing the course of the disorder and one of the causes of ineffective treatments. considering that between 20 and 60% of patients with bipolar disorder have problems with adherence. adherence is modulated by a number of socio-demographic, clinical and neuropsychological factors. it is also modulated by the knowledge, beliefs and in addition, studies have shown that the reasons attributed to poor adherence are different depending on whether questioning patients or healthcare professionals. this fault diagnosis, assessment of the causes and "fit" into the reasons associated with poor adherence is an aggravating factor of the problem. however, this factor seems modifiable by better training of professionals. a team from newcastle university in england has developed a training program for all health professionals to improve the diagnosis and understanding of compliance issues in bipolar patients and provide simple tools to fight against patients with this problem. the investigators assume that this training will improve medication adherence among outpatients by trained professionals.


Eligibility criteria:
inclusion criteria: * suffering from bipolar disorder type 1, type 2 or unspecified according to the dsm iv * do not presenting mood episode as defined in dsm iv * with at least one medication prescribed mood stabilizer goal, whatever its observance exclusion criteria: * patients full-time hospitalized at the time of inclusion
the clinical and hemodynamic course of cardiogenic shocks hospitalized in critical care

Conditions: Cardiogenic Shock

Summary: cardiogenic shock is a frequent reason for hospitalization in critical care units, with high mortality (50%). several french registries have been created to improve knowledge of the prognostic factors of cardiogenic shock. in recent years, temporary mechanical circulatory support has become more important in cardiogenic shock. the monitoring of catecholamines is also performed with a global score: the vaso-inotropic score. the purpose of our study is to consider using these new data and techniques to create a cohort of cardiogenic shock within our critical care unit. this observational study is based on clinical, biological, and hemodynamic data recorded during the icu stay of patients for cardiogenic shock. the primary endpoint is the relationship between the hemodynamic evolution of cardiogenic shock and in-hospital mortality.


Eligibility criteria:
inclusion criteria: * patients hospitalized in icu for cardiogenic shock * patient with cardiogenic shock as defined by the frenschock2 study criteria exclusion criteria: * patient with cardiogenic shock in the context of septic shock and hemorrhagic shock

Keywords: cardiogenic shock vaso-inotropic score
bovine colostrum efficacy for the treatment of chronic prostatitis symptoms.

Conditions: Chronic Prostatitis (CP); Chronic Prostatitis With Chronic Pelvic Pain Syndrome; Chronic Prostatitis/ Pelvic Pain Syndrome

Summary: chronic prostatitis/chronic pelvic pain syndrome (cp/cpps) is a bothering condition characterized by pain localized to the pelvic, perineal and/or genital area and lower urinary tract symptoms (luts). phytotherapy, which involves the combination of two or more active compounds, can be used to treat this challenging condition. the aim of this study was to investigate the role of an oral combination of colostrum and serenoa repens extracts (prostym®) in the treatment of cp/cpps patients. the main questions the present study aims to answer are: * does prostym® enhance quality of life of cpp/cpps patients? * does it help reducing pain symptoms of cpp/cpps patients? researchers will investigate whether prostym® works to treat cpp/cpps symptoms, so its efficacy, but also its tolerability and adherence to therapy. participants will: * take prostym® every day for 6 months; * visit the clinic for follow-up visits at 3 and 6 months; * answer validated questionnaires and declare potential adverse events at follow-up visits.


Eligibility criteria:
inclusion criteria: * adult male patients (aged \>18 years) * clinical affection by cp/cpps with symptoms that persisted for ≥6 months; * cpsi pain domain score ≥5 points; * negative meares and stamey test score. exclusion criteria: * patients with prevalent bph symptoms (cpsi pain domain \<5), acute prostatitis, chronic bacterial prostatitis (positive meares and stamey test), prostate or bladder cancer, urethral stenosis or neurological bladder; * no other drug or supplement specific to chronic prostatitis in the previous 30 days.

Keywords: chronic prostatitis chronic pelvic pain syndrome prostym® bovine colostrum luts pain
registry study on drug therapy and clinical outcomes in patients with acute coronary syndrome

Conditions: Drug Therapy; Acute Coronary Syndrome

Summary: registry study on drug therapy and clinical outcomes in patients with acute coronary syndrome


Eligibility criteria:
inclusion criteria: * informed consent has been signed. * patients diagnosed in our hospital with acute coronary syndrome. * age ≥18. * life expectancy ≥12 months. exclusion criteria: * severe lack of important information such as history of previous medication, history of previous disease, history of surgery. * pregnant and lactating women. * mental disorders, or inability to communicate effectively with researchers, or failure to comply with research protocols.
effect of inguinal hernia repair on isokinetic muscle strength

Conditions: Inguinal Hernia

Summary: the aim of the present prospective controlled study is to compare the trunk muscle strength, quality of life and neuropathic pain component after lichtenstein and kugel procedures.

in this study patients underwent inguinal hernia repair will be evaluated for the effect of the surgical procedure on abdominal muscle strength.

Eligibility criteria:
inclusion criteria: * signed written informed consent * male gender (for minimizing the certain effect of gender to muscle strength) * patients aged 18-65 years' old * having no previous surgery * patients within six months to postoperative first year * ability to speak, read, and write turkish exclusion criteria: * infections or tumors of the spine * systemic bone or joint disorders (e.g., rheumatoid arthritis) * unstable cardiovascular and pulmonary diseases * polyneuropathies and musculoskeletal system diseases * presence of a diagnosed severe psychiatric disorder * presence of severe pain * regular exercise habit * recurrent operation for a hernia * presence bilateral inguinal hernia on concurrent femoral hernia * if the calculated body mass index is lower than 20kg/cm2 or over than 35kg/cm2