Kornimate/medical-research-clean huggingface dataset:
comparison of liver trauma in two retractors used in sleeve gastrectomy

Conditions: Obesity

Summary: in laparoscopic sleeve gastrectomy, retraction of the left lobe of the liver is important for an effective visualisation. there are many retractors available for this retraction. a study is designed to compare two different liver retractors for liver trauma; nathanson liver retractor that is used more commonly and reveel liver retractor that has more recent history of use.

a randomised controlled prospective study is designed with 80 patients over 3-month period (january 2017 to march 2017). laparoscopic sleeve gastrectomy is planned for all patients. two groups are designed depending on retractor. liver retraction will be provided with nathanson retractor in first group (nathanson group, 40 patients), and with reveel retractor in second group (reveel group, 40 patients). preoperative serum levels of transaminases, total bilirubin and c-reactive protein will be measured in all patients. the same biochemical markers will be measured on days 1 and 2 postoperatively. the patients with body mass index (bmi) ≥35kg/m2 are enrolled to study. the parameters of demographic characteristics (age, gender, bmi, weight, and body fat percentage), and clinical outcomes (postoperative complications, mortality, readmissions) are planned to record. operative technique all patients will be operated by same surgeons. and anesthetist. peroperatively intravenous paracetamol 10 mg, tramadol 50 mg and fentanyl 150 mcg will be used for analgesia. laparoscopic sleeve gastrectomy will be performed with 5 trocars, in reverse trendelenburg position by creating pneumoperitoneum with 14 mmhg carbon dioxide insufflation. trocar replacements are one 10-mm trocar in the midline above umbilicus for the endoscope, one 12-mm trocar to right midclavicular line linage to the 10-mm trocar. one 5-mm trocar to the left midclavicular line linage to the 10-mm trocar, one 5-mm trocar to the front axillary line below the left costal margin. both liver retractors will be placed from 2 cm below the xiphoid process for liver retractor. in nathanson group; after placing the blade of nathanson retractor below the left lobe of the liver, it will be fixed to the operating table by the other instruments of retractor. in reveel group; the retractor will be placed below the left lobe of the liver and then it will be fixed to the skin with a towel clamp. 38 f orogastric tube will be used. no use of nasogastric tubes and urinary catheters routinely is planned. drain replacement is planned for all patients. preoperative and postoperative values of the markers will be analysed and compared between two groups.

Eligibility criteria:
inclusion criteria: * patients with bmi\>35 exclusion criteria: * patients with known liver disease

Keywords: sleeve gastrectomy liver retractor nathanson reveel liver trauma
to evaluate effects of azd1446, placebo and donepezil in patients with alzheimer's disease

Conditions: Alzheimer´s Disease

Summary: the purpose of this study is to evaluate whether treatment with single and multiple oral doses of azd1446 for 1 week will have effect on quantified electroencephalography and event-related potentials in patients with alzheimers disease. the total treatment period is 9 weeks, divided into 5 equally long sub-periods of 7 days and 4 wash-out periods of 7 days each.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of probable alzheimer´s disease * hachinski ischaemic score \< 4 * mse score 18 to 24 exclusion criteria: * history of any clinically significant disease or dementia other than alzheimer´s disease * current major depressive disorder or other major psychiatric disorders

Keywords: phase ii alzheimer's disease eeg cognition pharmacodynamic
tc99m-maa bronchial artery injection during bronchial embolization for pulmonary mass induced hemoptysis for dosimetry planning

Conditions: Lung Cancer

Summary: this research study will evaluate the administration of a particle called macro-aggregated albumin (maa) labelled with the radiotracer technetium 99m (tc99m) as a proxy to estimate the anticipated dose of radiation to tumor and adjacent structures. administration of this labeled maa will not have a therapeutic benefit on the participant's cancer. administration will help researchers determine if arterial administration of radiation may be feasible for lung cancer in the future.

this research study is a pilot study, which is the first time investigators are examining this study intervention. as mentioned above, standard of care treatment for stage iii lung cancer includes chemotherapy and stereotactic body radiation therapy. however, arterial administration of radiation to these tumors may represent an alternative method of radiotherapy, with dose directly administered to the tumor. the potential radiation dose to the tumor and adjacent structures is not known. this study aims to estimate the dose of radiation to tumor and adjacent structures in the chest via administration of a radiotracer called tc99m-maa. tc99m-maa is a particle that is used to assess blood flow distribution and has a similar size to the particles that are utilized for arterial delivery of radiation therapy, also called radioembolization. tc99m-maa is currently used to estimate radiation dosimetry prior to arterial radiotherapy administration for liver malignancies. if this study is successful, the results will allow doctors to use the distribution of tc99m-maa to estimate radiation dose to tumors and adjacent structures in the setting of intra-arterial radiation therapy. this will provide information to plan future therapy with intra-arterial radioembolization for lung malignancies.

Eligibility criteria:
inclusion criteria: * subjects 18 years of age and older * patients with known active lung cancer with a history of hemoptysis presenting for standard of care bronchial artery embolization will be considered. * patients must be presenting for secondary prophylaxis of hemoptysis. * if female, not of childbearing potential or negative serum β-hcg pregnancy test prior to cta chest and radiotracer injection. * if female, not nursing. * willing and able to understand and sign a written informed consent document. * willing and able to undergo all study procedures exclusion criteria: * patients with current active hemoptysis * any acute or chronic inflammatory disease or medical conditions that in the investigator's opinion may interfere with the study procedures or the interpretation of the study results. * subjects who have exclusion criteria that would prevent them from receiving a ct scan or fluoroscopy, or administration of contrast. * history of allergic reactions or hypersensitivity attributed to compounds of similar chemical or biologic composition to macro-aggregated albumin * patients with severe pulmonary hypertension. * glomerular filtration rate \< 30 * platelets \< 30 * inr \> 3.0

Keywords: lung cancer
study to evaluate effects of inl1 in patients with heart failure and reduced ejection fraction

Conditions: Heart Failure; Reduced Ejection Fraction

Summary: this is a multicenter, randomized, double-blind, placebo-controlled, dose-response trial in patients with chronic stable heart failure (hf) and reduced left ventricular ejection fraction (lvef) to evaluate the efficacy and safety of three inl1 doses compared with placebo. patients will be treated for approximately 12 weeks with one of three inl1 doses: 50 mg, 150 mg, 300 mg, or, placebo capsules, taken twice daily (bid).


Eligibility criteria:
inclusion criteria: * clinical diagnosis of hf requiring chronic treatment of loop diuretics * left ventricular ejection fraction (lvef) ≤ 40% at screening by echocardiography * n-terminal-prohormone of brain natriuretic peptide (nt-probnp) ≥400 pg/ml at screening for patients without atrial fibrillation or atrial flutter, or, nt-probnp ≥ 1,200 pg/ml at screening for patients with atrial fibrillation or atrial flutter * treated for heart failure with stable, optimal pharmacological therapy * acceptable screening echocardiographic image quality exclusion criteria: * female patients of childbearing potential * patients with a new york heart association (nyha) class i or iv * heart failure that is clearly caused by toxin / drug such as adriamycin * significant medical conditions or recent history suggesting the patient's study participation will potentially pose a major risk to patient's safety and well-being * need for routine scheduled outpatient iv infusions for heart failure or scheduled ultrafiltration * history of rhabdomyolysis or history of autoimmune diseases * severe renal disease * hepatic disease * pulmonary disease limiting exercise capacity * atrial fibrillation with rapid ventricular response * life expectancy of less than 6 months * type 1 diabetes mellitus or type 2 diabetes mellitus with very poor glycemic control * patients with anemia

Keywords: heart failure
alvocade® (bortezomib) safety and effectiveness study

Conditions: Multiple Myeloma, Refractory

Summary: this study is a phase iv, post-marketing, observational, cohort study for safety and effectiveness evaluation of alvocade® use in iranian patients with multiple myeloma. no control groups were considered in the study design. the primary objective of this study was safety assessment, including the incidence of adverse events (aes).

this study is a phase iv, post-marketing, observational, cohort study for safety and effectiveness evaluation of alvocade® use in iranian patients with multiple myeloma. data were gathered in two booklets, containing information on sixteen injections, which were filled by the designated physician. exposure to alvocade® in this study was defined as administration of bortezomib (alvocade®, nanoalvand) with a dose of 1.3 mg/m2, once every 3 weeks during 2.5 to 5.5 months (16 injections). the primary objective of this study was safety assessment, including the incidence of adverse events (aes). this study was single arm and the sample size of this study was 59 patients.

Eligibility criteria:
inclusion criteria: * patients with multiple myeloma were included in the study. exclusion criteria: * there were no exclusion criteria for this study.

Keywords: multiple myeloma bortezomib safety alvocade
radiotherapy to the primary in metastatic non-small cell lung cancer patients

Conditions: Non-Small Cell Carcinoma of Lung, TNM Stage 4; Radiation Therapy

Summary: study the effect of radiotherapy to the primary lesion after first line systemic therapy in metastatic non-small cell lung cancer patients.

metastatic non-small cell lung cancer patients after receiving their first line systemic therapy according to their genetic mutation will be randomized to follow up versus radiotherapy to the primary lesion.

Eligibility criteria:
inclusion criteria: 1. confirmed histological diagnosis of nsclc. 2. stage iv disease. 3. patients with p.s ≤ 2. 4. finished at least 4 cycles of platinum-based doublet chemotherapy if patient has no diver mutation, or at least 3 months of anti-egfr, anti-alk according to their driver mutation with sd, pr or cr. exclusion criteria: 1. history of prior irradiation to the lung. 2. residual malignant pleural or pericardial effusion at randomization time. 3. history of prior malignant tumor likely to interfere with the treatment protocol. 4. severe comorbidities as measured by morbidity index. 5. disease progression on first line systemic therapy.

Keywords: bronchogenic cancer lung cancer
treatment of pelvic ring fractures in the elderly

Conditions: Pelvic Pain

Summary: pelvic ring fractures in the elderly are associated with high morbidity during standard conservative treatment due to immobility. furthermore the risk of long term dependence even after the fracture has united is high. in analogy to the treatment of hip fractures in a similar patient population, patients might benefit from surgical treatment due to a reduction in pain and early mobilization.

comparison of surgical vs conservative treatment with respect to mobility, pain, morbidity and mortality.

Eligibility criteria:
inclusion criteria: * cti/mri verified fracture of the sacrum affecting the posterior ring or both posterior and anterior ring * age\>65 years, ambulatory with/without walking aids before trauma * ambulatory with/without walking aids before trauma * postmenopausal status in women * informed consent for study participation and surgery exclusion criteria: * refusal of consent by the patient or legal representatives to participate in the study * other fractures or * unstable pelvic fracture (type b or c according to classification of 'arbeitsgemeinschaft für osteosynthesefragen' (ao)/ota) requiring surgical stabilisation after high- or low-energy trauma * suspicion of a pathological fracture in the context of known or unknown malignancy * previous surgery of the pelvis with metal obstructing the planned paths of the ilio-sacral screws * symptomatic low back pain with morphological changes, i.e. intervertebral disc displacement, neoplasm metastasis in the axial skeleton, spinal stenosis, vertebral fracture, spondylarthropathy etc. * comorbidity that precludes undergoing general or spinal anaesthesia * pre-trauma mobility status that precludes achieving a post-trauma mobility status enabling the patient to perform the timed up and go test (e.g. patient being in a wheel chair)

Keywords: treatment
development of biomarker for development of non-alcoholic steatohepatitis (nash) in children

Conditions: Non-Alcoholic Steatohepatitis

Summary: the purpose of this study is to document how often specific genotypes known to be associated with adult-onset nash (non-alcoholic steatohepatitis) occur in a pediatric cohort and investigate whether these genotypes are associated with increased susceptibility to nash.

nash is a clinico-pathological entity characterized by the development of histological changes of inflammation and fibrosis in the liver that are nearly identical to those induced by excessive alcohol intake, but in the absence of alcohol abuse. nonalcoholic steatohepatitis occurs commonly children with additional comorbidities such as obesity and diabetes mellitus. paralleling the increasing prevalence of obesity and type 2 diabetes in the pediatric population, nonalcoholic fatty liver disease (nafld) and especially its more severe histological form nash, is expected to become one of the most common causes of end-stage liver disease in both children and young adults. although no genome wide association studies have been conducted in association with nash to date, individual candidate gene investigations have identified several genes associated with increase susceptibility to nash in adults including the microsomal triglyceride transfer protein (mtp) which regulates the incorporation of triglycerides into apolipoprotein b and a key enzyme for the assembly and secretion of vldl from hepatocytes, the manganese superoxide dismutase (mnsod) gene which catalyzes the conversion of two molecules of superoxide anion, a highly unstable ros, into hydrogen peroxide and oxygen more stable ros, and lastly, phosphatidylethanolamine n-methyltransferase (pemt) which is required for hepatic secretion of triacylglycerol in very low density lipoproteins (vldl). we propose the following aim: aim 1: to document the frequency of specific genotypes, previously identified to be associated with adult-onset nash, in a purely pediatric cohort. aim 2: to investigate whether these genotypes are associated with increased susceptibility to nash and increased occurrence of fibrosis in the cohort of pediatric subjects. our hypothesis would be: a significantly higher proportion of the polymorphisms would exist in those subjects with nash compared to controls. aim 3: to investigate the presence of other polymorphisms or other biomarker that are indicative of pediatric nash. such that our secondary hypothesis would be: specific polymorphisms or biomarkers will be identified that will indicate a higher probability of nash.

Eligibility criteria:
inclusion criteria: * all subjects aged 2-18 with biopsy proven nafld and/or nash undergoing a blood draw and willing to consent to this study will qualify for inclusion in this protocol. exclusion criteria: * other causes of chronic liver disease or other chronic diseases, specifically autoimmune disorders, immunodeficiencies, or individuals with congenital/genetic disorders * chronic viral hepatitis, wilson's disease, or alpha -1- antitrypsin deficiency * acute life threatening illness or conditions

Keywords: nash biomarker
obt measurement to differentiate between presence and absence of hcc determined by mri

Conditions: HCC

Summary: the exalenz clinical investigation is a multicenter, non-randomized, study of the ¹³c-octanoate breath test (obt). the present study is a feasibility trial, which aims to evaluate the capability of the obt to differentiate between presence and absence of hcc determined by magnetic resonance imaging (mri) in patients with chronic liver disease.

1. informed consent will be obtained from all patients prior to enrollment. 2. the trial will be conducted in compliance with this protocol, with gcp standards, and the applicable regulatory requirements. 3. this study will be cross-sectional, where patients will be enrolled on a walk in basis. once one arm is completed the other one will be enriched in order to obtain at least 50 positive and at least 50 negative hcc subjects as defined by mri. 4. all patients will undergo afp and us if they do not have results within the past three months. 5. if the patient undergoes liver fna, the biopsy results will be evaluated for the presence of hcc. 6. for all patients, a case report form will be completed. 7. all patients will undergo a physical examination, and their medical history/concomitant medications, weight, height and age will be recorded. furthermore, recent (past 3 months) blood test results, if available, may be recorded. 8. if relevant (woman of child bearing age), a pregnancy test will be performed to rule out pregnancy when performing the breath test. 9. all mri negative patients with low obt results will undergo additional mri within 6 to 12 months post obt to rule out hcc occurrence. 10. if available, all additional mri/ct/us results will be recorded within the patient's crf.

Eligibility criteria:
inclusion criteria: 1. any patients with chronic liver disease at risk for hcc. 2. age ≥ 18 years. 3. patient has an mri result (positive or negative for hcc) up to 3 months prior to recruitment or will be scheduled for an mri during the trial period. 4. patient is naïve to hcc treatment (rfa or tace or oral hcc treatments) since last mri. exclusion criteria: 1. any patients with chronic liver disease at risk for hcc. 2. age ≥ 18 years. 3. patient has an mri result (positive or negative for hcc) up to 3 months prior to recruitment or will be scheduled for an mri during the trial period. 4. patient is naïve to hcc treatment (rfa or tace or oral hcc treatments) since last mri. 5. patients currently receiving total parenteral nutrition if they have contraindications to oral drugs. 6. women who are pregnant or breast feeding. 7. patient taking drugs that can interfere with octanoate metabolism or can also cause nafld independent of the metabolic syndrome, including: corticosteroids, amiodarone, tetracycline, valproic acid, methotrexate, stavudine, zidovudine. 8. patient, based on the opinion of the investigator, should not be enrolled into this study. 9. patient unable or unwilling to sign informed consent. 10. patients that are participating in other clinical trials evaluating experimental treatments or procedures
development and validation of a digital twin-based clinical research system (x town stage i)

Conditions: Chronic Disease

Summary: chronic diseases, characterized by their prolonged duration and slow progression, have emerged as predominant contributors to global morbidity and mortality. the investigators have developed a digital twin-based clinical research system (termed x town) for chronic diseases, to predict clinical outcomes under various interventions. in this study, the investigators aim to evaluate the reliability of the developed digital twin-based clinical research system in predicting short-term clinical outcomes via virtual and real-world clinical studies.


Eligibility criteria:
inclusion criteria: 1. age≥18 years old 2. receiving care at a community health service centre 3. able to understand and comply with the study procedures 4. agrees to participate in the study and signs the informed consent form exclusion criteria: 1. patients with severe mental illness 2. patients expected to be unable to complete follow-ups
role of oral steroids in reducing recurrence of urethral stricture after direct vision internal urethrotomy

Conditions: Recurrence

Summary: it was a randomized controlled trial conducted at department of urology, armed forces institute of urology, rawalpindi from 1st january, 2018 july 2019 to 31st march 2021 to determine the role of oral steroids after direct vision internal urethrotomy to reduce the recurrence rate of urethral strictures.


Eligibility criteria:
inclusion criteria: * patients with urethral stricture with restricted urine flow of \< 15 ml/min on uroflowmetry exclusion criteria: * patients presenting with post-anastomotic urethroplasty strictures (assessed on history and medical record), * patients with post-turp strictures * patients with neurogenic bladder * patients with prior history of steroid use * patients with extravasation during optical internal urethrotomy
safety and efficacy of the gore® septal occluder to treat ostium secundum atrial septal defects

Conditions: Septal Defect, Atrial

Summary: the primary objective of the gore® septal occluder study is to evaluate the safety and efficacy of the occluder device in the treatment of transcatheter closure of ostium secundum atrial septal defects (asds). the data obtained in this study will evaluate this next generation device as compared to outcomes of prior studies conducted with the gore® helex® septal occluder.

ostium secundum atrial septal defects present as a persistent communication between the atria and are a common congenital cardiac anomaly accounting for approximately 10% of all congenital heart disease. they are one of the most common congenital heart defects to present in adulthood. untreated, asds produce right heart volume overload and progressive impairment over time, including reduced aerobic capacity, atrial dysrhythmias, congestive heart failure, pulmonary hypertension, and potential paradoxical embolism. in the u.s. alone it is estimated that approximately 10,000 new patients per year can be expected to have an asd. successful surgical repair of asd has been performed for 50 years with continued improvement in technique and outcomes. king and mills reported the first transcatheter closure of asd in 1976, but the delivery system was quite large and impractical, especially for younger patients. with time, improvements in design concepts and materials discoveries have led to improved results in transcatheter closure systems. several devices are now available commercially for transcatheter asd closure.

Eligibility criteria:
inclusion criteria: * asd less than or equal to 17 mm. exclusion criteria: * conditions that would confound treatment of asd or complicate distinguishing onset of adverse events. * unable to accommodate device delivery catheter.