Kornimate/medical-research-clean huggingface dataset:
efficacy evaluation of the esophagogastric junction exposure obtained by the flexible liver retractor in gastroplasty

Conditions: Obesity

Summary: evaluation of a new technique of liver retraction for the exposure of the his angle in gastric bypass roux-en-y surgery.

obesity is a chronic disease of clinical treatment initially, but with precise surgical indications regulated by national and international health organizations. among the surgical techniques, the gastric bypass roux-en-y is considered the "gold standard" for its efficiency and low morbidity and mortality. in gastric laparoscopic surgery it is necessary to move the liver in order to ensure adequate working space and a good view. conventional laparoscopic retractors surgery are generally coarse, require an additional incision for its installation, or handling by an assistant during surgery and involve risk of liver injury. the objective of this study was to evaluate the efficacy of a flexible liver retractor in the exposure of the his angle in roux-en-y gastric bypass for morbid obesity. this was a prospective, controlled, open and comparative study, with 100 patients randomly divided into two groups (conventional and flexible retractor), with medical indication for bariatric surgery. data were recorded during surgery in both groups for comparison of the two hepatic retraction techniques.

Eligibility criteria:
inclusion criteria: * between 18 - 65 years, both genders, with indication of bariatric surgery according to ifso criteria. * agreed to participate and signed informed consent form. exclusion criteria: * patients who did not agree to participate and / or any other condition that the investigator judged relevant for not participating in the study were excluded.

Keywords: liver laparoscopy bariatric surgery esophagogastric junction obesity
trauma and cardiometabolic health in an american indian community

Conditions: Psychological Stress; Cardiometabolic Conditions; Mental Health

Summary: volunteers for the study are asked to participate in two laboratory sessions. in the first laboratory session, volunteers are asked to provide a blood sample which will be used to measure factors related to health. participants also complete questionnaires related to demographic and health-related information and undergo evaluations of their body composition. in the second laboratory visit, participants are asked to have cardiovascular, neuroendocrine, and inflammatory activity measured during a brief period of rest and during a short challenging psychological task. participants will also complete questionnaires. the study is designed to examine the associations between experiences such as trauma and resiliency with changes in bodily systems during a challenge and current health.

this cross-sectional study will examine the association between factors of resiliency and trauma with physiological (cardiovascular, neuroendocrine, inflammatory) responses to acute stress and current mental and physical health. study volunteers will include individuals who identify as american indian and currently live on and near the blackfeet reservation. study volunteers will be asked to provide information that will be used to measure: correlates of cardiometabolic and mental health, acute psychological stress, arterial stiffness. results of the study will help increase knowledge of cardiometabolic and mental health in the context of past and ongoing trauma and resiliency.

Eligibility criteria:
inclusion criteria: * 18-40 years * identifying as american indian * living on or near blackfeet reservation exclusion criteria: * uncontrolled hypertension
practicability and acceptability of stylomax® in children

Conditions: Growth Hormone Deficiency

Summary: primary objective: to evaluate the practicability and acceptability of stylomax®, a new injection device for maxomat®, in children, for 1 year.


Eligibility criteria:
inclusion criteria: * children over 3 years of age with growth hormone deficiency, requiring treatment with maxomat® according to the criteria of the ma. exclusion criteria: * the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
immunological and virological characterization of patients with chronic hbv-hdv infection: outcomes and response to bulevirtide treatment

Conditions: Hepatitis D

Summary: pharmacological, single-center, non-profit observational study. the present study is part of a cooperation project between the sc gastroenterology and hepatology, fondazione irccs ca' granda ospedale maggiore policlinico (milan, italy), the university of milan, the university of parma and rome tor vergata, funded under the call for research projects of significant national interest - 2022 pnrr call (prot. p2022wexp2). hepatitis d virus (hdv) is a defective rna virus, which requires the presence of hepatitis b virus (hbv) to infect liver cells and propagate. to date, the mechanisms underlying the accelerated disease progression in the natural history of delta hepatitis are poorly understood, as is the course of the hdv-specific immune response (cd4 and cd8 t cells). as in chronic hbv and hcv infections, the outcome of chronic hdv infection appears to be dictated primarily by the host immune response, which represents a key determinant for virus control or persistence. for hbv/hdv coinfection, the role of t cells has not been well defined, as suitable animal models are lacking and so far few hdv-specific t cell epitopes have been precisely mapped, mainly limited to hla-b alleles. the study is divided into two substudies (cross-sectional and longitudinal). the primary objective of the cross-sectional study is to calculate the prevalence of hdv-specific t responses in patients with chronic hbv-hdv infection naïve to treatment with bulevirtide. the primary objective of the longitudinal study is the change in the prevalence of hdv-specific t responses in patients with chronic hbv-hdv infection during treatment with bulevirtide compared to baseline (pre-treatment).


Eligibility criteria:
inclusion criteria: * 18 years of age or older * ability to understand and sign the informed consent * chronic hdv infection defined by positivity of hbsag antigen (hbv) and hdv rna (hbv-hdv co-infection) for at least 6 months at the time of enrollment. exclusion criteria: * co-infection with other viruses (hcv, hiv) * treatment with immunosuppressive/immunomodulatory drugs * other congenital and/or acquired immunodeficiency conditions
objective and perceived quality study in patients undergoing elective groin hernia surgery

Conditions: Inguinal Hernia; Quality of Life; Surgery; Survey

Summary: this is a prospective non-comparative observational study of cohorts. consists on offering surveys to every patient undergoing groin hernia surgery in our abdominal wall surgery unit, in hospital of navarra.

hypothesis: the objective and perceived quality data of the patients under study (adult patients undergoing scheduled inguinal hernia without complications) in pamplona are within the international quality standards. objectives primary objective: -obtaining data of objective and perceived quality of patients undergoing elective groin hernia surgery in pamplona durinag a year to compare them with international quality standards. secondary objectives: * obtaining data on duration of sick leave (temporary disability due to common contingency) associated with the referred procedures, as well as their possible complications. * assess the costs associated with the intervention and its possible complications. * raise options (if necessary and feasible) to improve the results exposed obtained by our service.

Eligibility criteria:
inclusion criteria: * patients entering surgical waiting list during a year (from march 1st, 2018, to february 28th, 2019). * elective surgery. exclusion criteria: * age below 16. * mental diseases. * patients not capable of understanding the study. * patients that reject entering the study.

Keywords: inguinal hernia quality of life survey surgery pamplona prospective observational cohorts
lenient rate control versus strict rate control for atrial fibrillation. the danish atrial fibrillation randomised clinical trial

Conditions: Atrial Fibrillation, Persistent; Atrial Fibrillation Chronic; Atrial Fibrillation

Summary: atrial fibrillation is the most common heart arrhythmia with a prevalence of approximately 2% in the western world. atrial fibrillation is associated with an increased risk of death and morbidity. the comparable effects of a lenient rate control strategy and a strict rate control strategy in patients with atrial fibrillation are uncertain and only one trial has assessed this previously in patients with permanent atrial fibrillation. the investigators will therefore undertake a randomised, superiority trial at four hospitals in denmark.


Eligibility criteria:
inclusion criteria: 1. participants with atrial fibrillation (ecg confirmed and diagnosed by the treatment provider) who at inclusion have either persistent (defined as atrial fibrillation for more than 7days) or permanent atrial fibrillation (only rate control is considered going forward). 2. rate control must be accepted as being the primary management strategy going forward. consideration towards whether rhythm control is more appropriate must be considered, especially given the results of the early treatment of atrial fibrillation for stroke prevention trial (east). 3. informed consent. 4. adult (18 years or older). exclusion criteria: 1. no informed consent. 2. initial heart rate under 80 bpm at rest (assessed via ecg before randomisation). 3. less than 3 weeks of anticoagulation with new oral anticoagulants or 4 weeks with efficient warfarin if indicated. 4. if the treating physician deems that the participant is not fit to be randomised into both groups based on an individual assessment. such a decision will be made before randomisation by the treating physician. this can e.g. be participants dependent on a high ventricular rate to maintain a sufficient cardiac output. such participants could be participants with heart failure, participants with a hemodynamically significant valve dysfunction, or severely dehydrated participants. 5. participants who are haemodynamically unstable and therefore require immediate electrical cardioversion

Keywords: rate control
ono-4538 phase i study in patients with solid tumor

Conditions: Advanced Solid Tumors; Recurrent Solid Tumors

Summary: the objective of the study is to investigate the pharmacokinetics of ono-4538 administered to korean patients with advanced or recurrent solid tumors who are refractory or intolerant to standard therapy or for whom no appropriate treatment is available.


Eligibility criteria:
inclusion criteria: * male or female ≥ 20 years of age * histologically or cytologically confirmed solid tumor * patients with advanced or recurrent solid tumors who are refractory or intolerant to standard therapy or for whom no appropriate treatment is available * ecog performance status is 0 to 1 exclusion criteria: * current or prior severe hypersensitivity to another antibody product * multiple primary cancers
early-onset pneumonia after out-of-hospital cardiac arrest

Conditions: Out-of-Hospital Cardiac Arrest

Summary: early-onset pneumonia after out-of-hospital cardiac arrest is frequent. an association between early-onset pneumonia and an increase in morbidity has been reported in this population. the diagnosis of early-onset pneumonia inpatients with out-of-hospital cardiac arrest may be challenging as diagnosis criteria are unspecific in this setting. on the other hand some studies have reported an association between early antibiotics and better prognosis in patients with out-of-hospital cardiac arrest suggesting that early diagnosis and treatment of pneumonia would benefit to patients. nonetheless, adminitration of antibiotics to any patients with out-of-hospital cardiac arrest would expose to antibiotic patients without infection and woould participate to increase in antibiotic resistance. therefore, the pp-acr study aims to evaluate the impact of a diagnosis algorithm including blinded sampling protected brushes on early-onset pneumonia treatment and patient prognosis after out-of-hospital cardiac arrest.

this study is a single centre observational study with a before - after design.

Eligibility criteria:
inclusion criteria: * patients admitted for out-of-hospital cardiac arrest and treated with hypothermia exclusion criteria: * age less than 18 * consent withdrawal

Keywords: early onset pneumonia out-of-hospital cardiac arrest prognosis antibiotic
tiotropium + procaterol vs tiotropium + placebo in copd patients

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: study compares the efficacy and safety of tiotropium + a beta agonist (procaterol) vs. tiotropium alone among patients with moderate chronic obstructive pulmonary disease

this study aims to determine the efficacy and safety of tiotropium plus procaterol in comparison to tiotropium plus placebo in filipino patients seen in manila, with moderate copd. after a 1-week wash-out period, 6-minute walk test, and st. george's respiratory questionnaire (sgrq) will then be administered prior to a run-in period of 1 week wherein all patients will be started on tiotropium alone. the patients will then be randomly allocated to either of the two arms for a two-week treatment, followed by one week washout, and crossed-over to the other treatment for another two weeks. the procaterol or placebo dose is given 2 hrs after the tiotropium dose.

Eligibility criteria:
inclusion criteria: 1. gold criteria for moderate copd (post-bronchodilator) * fev1/fvc \< 70% * 50% ≤ fev1 \< 80% predicted * with or without symptoms 2. willing to undergo the treatment protocol with signed informed consent exclusion criteria: 1. exacerbation within 1 month prior to run-in period 2. significant hypoxemia and/or desaturation at rest and during exercise. 3. significant cardiac, renal, or other systemic disease 4. history of adverse reaction to any of the two test drugs (tiotropium and procaterol)

Keywords: chronic obstructive pulmonary disease procaterol tiotropium
a study to evaluate the safety, tolerability, and efficacy of imb-1018972 in patients with non-obstructive hypertrophic cardiomyopathy trial

Conditions: Non-obstructive Hypertrophic Cardiomyopathy

Summary: the purpose of this study is to assess the safety, tolerability, and potential efficacy of imb-1018972 in patients with non-obstructive hcm.


Eligibility criteria:
inclusion criteria: * diagnosis of hypertrophic cardiomyopathy consistent with current us and european guidelines * ability to perform an upright treadmill cardiopulmonary exercise test * agreement to abide by contraceptive requirements exclusion criteria: * clinically significant concurrent condition which could prevent the patient from performing any of the protocol-specified assessments, represent a safety concern if the patient participates in the trial or could confound trial assessments of safety or tolerability * women who are pregnant, planning to become pregnant or lactating * participation in another clinical study involving a test product or invasive medical device within 28 days (or within 5 elimination half-lives of the respective test product, whichever is longer), prior to first dosing
comparison of posterior fixation alone and combined with articular process fusion in thoracolumbar burst fractures

Conditions: Thoracolumbar Burst Fracture

Summary: nearly 90% of all spinal fractures occur in the thoracolumbar region, and burst fractures are composed of 15% of such injuries. but the treatment of thoracolumbar fractures remains controversial. treatment varies from the conservative management to various types of surgery. internal fixation with spinal fusion is a surgical treatment method that is generally accepted for patients with thoracolumbar fracture. in this department, the investigators treat thoracolumbar burst fracture with posterior fixation alone and combined with articular process fusion. to evaluate the result of the two kinds of treatment, the investigators design this clinical trial. so, the investigators compared the radiological and clinical outcomes between patients who underwent posterior fixation alone and supplemented with fusion following the onset of thoracolumbar burst fractures.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of thoracolumbar burst fracture exclusion criteria: * smoking during the period of the trial * conservative treatment could be attempted * do not meet the requirements of follow-up

Keywords: operative treatment internal fixation posterior spinal fusion
evaluation of neural loss in multiple sclerosis and neuromyelitis optica using high resolution oct

Conditions: Multiple Sclerosis; Neuromyelitis Optica

Summary: the purpose of this study is to determine the ability of stratus oct and high resolution oct to detect and to quantify the neural loss in multiple sclerosis and neuromyelitis optica and its subtypes.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of multiple sclerosis or neuromyelitis optica * age between 15 and 60 years * bcva better than 20/400 * no optic neuritis crisis in the last 6 months exclusion criteria: * diagnosis of glaucoma, opacities or disc anomalies * diagnosis of macular disease * disc swelling at fundoscopy

Keywords: optic neuritis longitudinally extensive transverse myelitis retinal nerve fiber layer macular thickness
glucose uptake in metabolic tissues after bariatric surgery

Conditions: Obesity; Insulin Resistance

Summary: the goal of this study is to provide a comprehensive evaluation of whole-body and tissue-specific glucose metabolism after consuming a mixed meal in lean people and people with obesity, before and after 20-35% weight loss induced by roux-en-y gastric bypass or sleeve gastrectomy surgery.

obesity is associated with an impairment in postprandial glucose disposal, which is an important risk factor for type 2 diabetes (t2d). weight loss improves postprandial glycemic control. the difficulty in achieving successful weight loss by using lifestyle therapy (diet and physical activity) has led to an increased interest in bariatric surgery, which is the most effective available weight loss therapy. moreover, bariatric surgery procedures that bypass the upper gastrointestinal tract, such as roux-en-y gastric bypass (rygb) and sleeve gastrectomy (sg), have profound effects on glycemic control and cause remission in a large percentage of people with t2d. however, the effect of rygb and sg surgery on postprandial glucose disposal among key metabolic organs has not been investigated and compared. the goal of this study is to provide a comprehensive evaluation of whole-body and tissue-specific glucose metabolism after consuming a mixed meal in lean people and people with obesity, before and after 20-35% weight loss induced by rygb or sg surgery. glucose uptake (gu) will be assessed by using: i) a combination of oral and intravenous stable isotopically-labeled glucose tracers to assess the delivery of ingested glucose into the systemic circulation and whole-body glucose disposal rate; and ii) positron emission tomography (pet) with magnetic resonance (mr) imaging to assess muscle, subcutaneous and visceral adipose tissue, liver, small intestine, and pancreas gu.

Eligibility criteria:
inclusion criteria: * bmi 35.0-50.0 kg/m2 for obese group and 18.5-24.9 kg/m2 for the lean group * must be scheduled for rygb or sg surgery exclusion criteria: * previous bariatric surgery * unstable weight (\>4% change during the last 2 months before entering the study) * significant organ system dysfunction (e.g., severe pulmonary or kidney disease) * cancer or cancer that has been in remission for \<5 years * conditions that render subject unable to complete all testing procedures (e.g. metal implants that interfere with imaging procedures; coagulation disorders) * use of medications that are known to affect the study outcome measures or increase the risk of study procedures and that cannot be temporarily discontinued for this study * pregnant or lactating women * persons who are not able to grant voluntary informed consent * persons who are unable or unwilling to follow the study protocol or who, for any reason, the research team considers not an appropriate candidate for this study, including non-compliance with screening appointments or study visits
clinical trial to evaluate the efficacy and safety of ckd-495 tablet

Conditions: Gastritis

Summary: to evaluate the efficacy and safety of ckd-495

a phase 2, multi-center, randomized, double-blind, parallel-group trial to evaluate the efficacy and safety of ckd-495 in patients with acute and chronic gastritis

Eligibility criteria:
inclusion criteria: 1. male or female subjects aged ≥ 19 2. acute or chronic gastritis patients who have more than 1 erosion on endoscopy within 7days prior to the use of the investigator's product taken date 3. patients who have more than 1 subjective symptom exclusion criteria: 1. patients with peptic ulcer, gastroesophageal reflux disease, malignant tumor in the digestive system or coagulation disorder, or taking antithrombotic medicine 2. patients who have been taken any gastritis medicine that could affect the treatment: h2 receptor antagonist, ppi(proton pump inhibitor), antacid, improvement of movement in digestive system, prostaglandin, and protective agent for gastritis 3. patients who have to take medicine that could cause gastritis

Keywords: acute gastritis chronic gastritis cinnamic acid ckd-495
gelatines in pediatric patients

Conditions: Treatment of Hypovolemia and Shock

Summary: the aim of volume replacement is to compensate a reduction in the intravascular volume e.g. during surgery and to counteract hypovolemia in order to maintain hemodynamics and vital functions. so far, there is only few data on the safety and efficacy of the products under investigation in children. the primary aim of this non-interventional observational study (nis) is to collect further data of gelatine solutions in a large pediatric population during routine clinical practice.


Eligibility criteria:
inclusion: * age ≤ 12 years * american society of anesthesiologists (asa) risk score: ≤ iii * peri-operative infusion of gelatine solutions * informed consent and/or data protection declaration signed by parents/legal guardians (according to local requirements) exclusion: * inclusion in another investigational study in the field of volume replacement which could interfere with the routine clinical practice regarding the administration of the gelatine solutions * in addition contraindications as outlined in the valid local summaries of product characteristics (smpcs) have to be considered.

Keywords: pediatric patients gelatine