Kornimate/medical-research-clean huggingface dataset:
alto endograft italian registry

Conditions: Abdominal Aortic Aneurysm

Summary: the aim of present study is to evaluate intraoperative, peri-operative, and post-operative results in patients treated by the alto stent graft (endologix inc. irvine, calif) for elective abdominal aortic aneurysm repair in a multicentric consecutive experience.

thirty years ago, juan parodi developed the first prototype of endograft for endovascular aneurysm repair, a handmade device made of a tube-shaped aorto-aortic graft sutured at each end to a balloon-expandable stent based on the design of radiologist julio palmaz. this device was implanted in a human body for the first time on september 7, 1990, in buenos aires, argentina. by 1994, the first commercially available devices had been launched onto the market. stent-graft material and design changed in various ways to improve conformability, reduce fracture, and minimize device migration rates. over the years endovascular aneurysm repair has become an effective treatment of aaa in challenging anatomy as hostile neck and small access. these performances have been achieved thanks to continuous technological development to overcome the previous limitation in endovascular aneurysm repair applicability. since 2010, the ovation abdominal stent graft system (endologix inc. irvine, calif) has offered a new concept of sealing, achieved by a network of o-rings filled with a polymer that can treat a great variety of difficult anatomies through a low-profile platform. in the latest version of the stent-graft, called ovation alto, the conformable o-rings with customsealtm polymer have been repositioned near the top of the endograft, providing a seal just below the renal arteries. very few papers were published highlighting the early and late outcomes of this new device. in this perspective, this study is intended to be the first multicenter prospective registry regarding the implantation of alto stent graft.

Eligibility criteria:
inclusion criteria: * elective aaa patients that should be treated by standard evar, according to endologix alto endograft device's instructions for use; * patient is willing to comply with specified follow-up evaluations at the specified times for the duration of the study; * patient is \>18 years old; * patient, or their legal representative, understands the nature of the procedure and provides written informed consent, prior to enrollment in the study. exclusion criteria: * evar performed in urgent/emergent setting; * patients treated outside endologix alto endograft device's instructions for use; * patients refusing treatment; * patients for whom antiplatelet therapy, anticoagulants or antihypertensive drug are contraindicated; * patients with a history of prior life-threatening contrast medium reaction; * life expectancy of less than follow-up period. aaa: abdominal aortic aneurysm; evar: abdominal endovascular aneurysm

Keywords: abdominal aortic aneurysm aaa endovascular aneurysm repair evar endograft
clinical, functional and inflammatory evaluation in asthmatic patients after a simple short-term educational program

Conditions: Asthma; Inflammation; Patient Relations, Nurse; Spirometry

Summary: background: patient education is one of the pillars of asthma treatment according to gina guidelines. it has considered essential for adherence to treatment and for correct technique of inhaled devices.

objective: analyze clinical, functional and inflammatory features of adult patients with partly controlled and uncontrolled asthma, before and after an educational intervention. methods: 58 adult asthmatic patients (18-70 years old) were randomized into two groups: intervention group (ig) (n=38) or control group (cg) (n=26). ig patients were submitted to three 30-minutes intervention of a shortterm educational program delivered by a nurse in 3 visits with a one-month interval. cg group did not receive educational intervention. all patients were submitted to a spirometry, induced sputum collection, nitric oxide measure, collecting exhaled condensed (cytokine analysis) air and it's ph measure, asthma control test (act), asthma control questionnaire (acq), asthma quality life questionnaire (aqlq), beck depression inventory (bdi), and answered a symptoms diary, statistical analysis: repeated measures (sigma plot software 3.0).

Eligibility criteria:
inclusion criteria: * non-smokers or those who stopped smoking more than five years ago * age between 18-69 years * be legally capable * response to the short-acting bronchodilator fev1\> 12% and\> 200 ml * absence of upper airway infection during 30 days and associated systemic diseases exclusion criteria: * smokers * over 70 years old * airway infection * legally incapable persons * diseases that may affect respiratory function

Keywords: asthma inflammation patients education spirometry
exercise in patients with post-concussion symptoms

Conditions: Craniocerebral Trauma; Head Injury, Minor; Postconcussion Syndrome; Posttraumatic Headache; Mild Traumatic Brain Injury

Summary: physical activity and exercise have traditionally not been much of a focus in treatment of postconcussion symptoms and posttraumatic headache. on the contrary, patients have often got advice to rest until they were free from symptoms. this approach, however, is challenged, and complete rest should probably be discouraged after the first 24-72 hours. moderate aerobic exercise has been found promising in the early phase after sports-related concussion, and in the treatment of patients with headache. this study is an open pilot-study of guided, home-based exercise in a clinical sample with postconcussion symptoms and posttraumatic headache after mixed-mechanism mild traumatic brain injury and minimal head injuries. the study will result in data about the feasibility and possible effects of exercise as treatment for prolonged postconcussion symptoms and posttraumatic headache.


Eligibility criteria:
inclusion criteria: * having sustained a minimal head injury (according to the head injury severity scale, hiss) or mild traumatic brain injury (tbi) (according to the tbi definition and the who criteria for mild tbi) within the last three years). * post-concussion symptoms of at least moderate degree (according to the rivermead postconcussion symptom questionnaire rpcsq) occurring within the first week after the head injury and/or posttraumatic headache according to the international classification of headache disorders 3 (ichd-3) criteria. * outpatients at st olavs hospital clinic of physical medicine and rehabilitation, department of acquired brain injury exclusion criteria: * symptoms better explained by other conditions. * severe communication problems, typically due to language problems. * severe psychiatric, neurological, somatic or substance abuse disorders that will complicate follow-up and outcome assessment. * orthopedic injury or other disability too severe for performing the test or the intervention. * cardiovascular conditions or risk factors that are not compatible with testing or safe unsupervised exercise.

Keywords: exercise exercise therapy treadmill symptom threshold postconcussion symptoms
a study of duloxetine in the treatment of fibromyalgia

Conditions: Fibromyalgia

Summary: this study is designed to evaluate duloxetine for the treatment of fibromyalgia syndrome patients.


Eligibility criteria:
inclusion criteria: * meet criteria for primary fibromyalgia syndrome as defined by the american college of rheumatologists exclusion criteria: * treatment with a monoamine oxidase inhibitor within 14 days prior to visit 2 or the potential need to take within 5 days after discontinuation from the study. * any patients judged by their physicians to be at serious suicidal risk. * have uncontrolled narrow-angle glaucoma
ckd-504 in sad and mad in healthy korean and caucasian adult male and female subjects

Conditions: Huntington Disease

Summary: to assess the safety, tolerability, pharmacokinetics (pk) and pharmacodynamics (pd) of single and multiple ascending oral doses of ckd-504 compared to placebo in healthy korean and caucasian adult subjects


Eligibility criteria:
inclusion criteria: * healthy adult korean or caucasian aged 19 to 45 (inclusive) years, at the time of screening. * subjects weighing ≥ 50 kg with bmi between 18 and 27 kg/m2 (inclusive) at screening visit. * subjects who agreed to voluntarily participate in this study and comply with all the protocol requirements by signing informed consent form after being informed of the nature of this study and understanding all aspects of this study. * subjects who were deemed as eligible subjects by investigators on their physical examination, laboratory findings, and medical examination by interview. exclusion criteria: * subjects with a history of hypersensitivities to the drug, including investigational drugs or other drugs or with a history of clinically significant hypersensitivities. * subjects with a history of drug abuse or a positive urine screening for drug abuse. * subjects who have participated and taken investigational drug in any other clinical trial (including bioequivalence study) within three months prior to study drug administration. * subjects who have donated a unit of whole blood within 60 days or blood components within 30 days prior to study drug administration. * subjects judged ineligible for the study after a review of the clinical laboratory results by the investigator or for other reasons.
neurofeedback-eeg-vr system for non-opioid pain therapy

Conditions: Pain Management

Summary: this study will assess the feasibility of developing the neurofeedback-eeg-vr (nevr) system for non-opioid pain therapy. subjects suffering from pain will undergo sessions involving vr and neurofeedback training and their pain will be assessed.

quasar and ucsd are conducting a clinical trial on 25 subjects to evaluate the feasibility of a novel neurofeedback electroencephalography (eeg) virtual reality (vr) system aimed at reducing chronic pain. the nevr device consists of a dry electrode eeg headset combined with a vr head-mounted display (vr-hmd) device and neurofeedback software. this approach relies on retraining the brain's networks to reduce the perception of pain and does not involve pharmaceutical drugs. patients with chronic lower back pain will be recruited by ucsd at its altman clinical \& translational research institute. patients that meet the recruitment criteria will be asked to conduct 20 1-hour long sessions of eeg-based neurofeedback in vr over the course of a couple of months. pain assessment and device usability questionnaires will be conducted prior to and after the first and last sessions, and at intermediate time points. this will be a single arm clinical trial aimed at demonstrating the safety and viability of the nevr device, with the primary outcome measure being the ability of patients to conduct all 20 sessions safely and comfortably. secondary outcome measures include assessment of changes in pain perception, and of changes in eeg activity patterns.

Eligibility criteria:
inclusion criteria: * chronic back pain that can be of multifactorial etiology inclusive of axial and radicular back pain * report a numerical rating scale (nrs, or visual analog score vas) score of greater than 6/10 * must be willing to for the duration of the study make no pharmacological adjustments or have additional interventional therapies, as reported by the patient * must have the cognitive capacity to provide consent/assent * must be able to sit up in a chair during the recording session * must demonstrate understanding of the protocol, its purpose and subject participation * must be fluent in english exclusion criteria: * measured head size too small or too large for the eeg equipment * any significant skull defect * history of a recent craniotomy (within the last six months) * any signs of scalp inflammation, irritation, or abnormal skin conditions * history of epilepsy or seizures * known allergies to any material to be used in this project * sight disabilities that make participation impractical * hair styles with thick braids or dread locks
tumor budding in patients with colorectal cancer under different mmr status

Conditions: Tumor Budding; Rectal Cancer

Summary: this study investigates the ability of tumor budding to identify prognosis in different mmr states and different levels of tumor lymphocyte infiltration. tumor budding is usually defined as an isolated single cancer cell or a cluster of up to four cancer cells located at the front of an infiltrating tumor.

as a component of the tumor microenvironment, tumor budding is associated with the epidermal mesenchymal transition of tumor cells and may predict disease progression and poor survival. the current assessment of tumor budding levels is mainly based on the itbcc grading system. the dmmr phenotype of colorectal cancer is associated with the generation of non-self-recognizing neoantigens by the immune system, with tumor-associated extensive inflammatory cell infiltration, and often the dmmr phenotype of colorectal cancer has a lower level of outgrowth, possibly with the generation of local immune responses capable of eradicating tumor budding cells. the prognostic value of the conventional tumor budding grading system has been validated mainly in stage i and ii colorectal cancers and does not consider the effect of mmr status on tumor budding. this retrospective study is designed to investigate whether the high grade of tumor budding under high immune response status implies immune escape of tumor cells and brings worse survival outcome, establish a more independent risk grading system to maximize the prognostic value of tumor budding in dmmr phenotype of colorectal cancer in combination with tumor-infiltrating lymphocytes.

Eligibility criteria:
inclusion criteria: 1. confirmed colorectal adenocarcinoma cancer pathologically 2. underwent primary surgery 3. with records for tumor budding staining 4. willing and able to provide written informed consent for participation in this study 5. non-complicated primary tumor (complete obstruction, perforation, bleeding) exclusion criteria: 1. with distant metastases at the time of initial diagnosis 2. without a complete pathological date 3. hereditary colorectal cancer 4. subjects with a history of a prior malignancy within the past 5 years, except for adequately treated basal cell or squamous cell skin cancer

Keywords: tumor budding rectal cancer
prognosis of nutritional status for surgical peri hilar cholangiocarcinoma

Conditions: Perihilar Cholangiocarcinoma

Summary: curative treatment of peri hilar cholangiocarcinomas is r0 surgery and require major hepatectomy with biliary tract resection. these complexe procedures can lead to high morbidity and mortality. a severe alteration of nutritional status before the surgery might be a poor prognosis for survival.

peri hilar cholangiocarcinomas are rare tumors, which when diagnosed at the resectable stage, require major hepatic resection associated with biliary reconstruction. these are complex procedures with a high morbidity and mortality, mainly due to postoperative hepatic failure and sepsis. these patients undergo optimization of liver function with portal embolization according to the volume of the future remaining liver and preoperative biliary drainage. on top of technical challenges of the surgery, the patients usually present a significant alteration of the general condition at the time of diagnosis, with denutrition that can be severe. the importance of evaluating the preoperative nutritional status in the context of oncological surgery is increasingly recognized in the literature. different nutritional scores exist such as the conut score, pni, or the evaluation of sarcopenia on imaging examinations and have shown an impact on morbi-mortality in liver surgery.

Eligibility criteria:
inclusion criteria: * surgical peri hilar cholangiocarcinoma from 01/01/2003 to 04/01/2021 at nancy university hospital exclusion criteria: * non curative surgery

Keywords: sarcopenia nutritional status surgery
drug interaction with genes in parkinson's disease

Conditions: Parkinson's Disease

Summary: this observational study aims at identifying gene modifiers of parkinson disease (pd) and of treatment response and adverse events of antiparkinsonian drugs. six hundred pd patients will be followed annually for up to 5 years. a biological collection will be associated with a full clinical assessment of motor and non motor symptoms, medical and treatment history, environmental factors. the association between candidate gene polymorphisms and disease or treatment complications will be analyzed.

title : drug interaction with genes in parkinson disease objective: to identify genes associated to disease and treatment complication and response. number of subjects: 500 study duration : 6 years design: prospective cohort with biological collection primary objective: identification of genes which polymorphism or haplotype is associated with a complication of parkinson disease, directly or with the interaction of treatment. secondary objectives: * prevalence and incidence of disease or treatment complications * clinical risk factor for disease or treatment complications * biomarkers of disease progression, disease or treatment complications

Eligibility criteria:
inclusion criteria: * men and women, age \> 18. * parkinson disease according to ukpdsbb criteria * pd diagnosis \< 6 years * informed consent exclusion criteria: - atypical parkinsonism

Keywords: parkinson's disease pharmacogenetics genetics
an intervention study on the effect of brazilian spinach supplementation on health outcomes among type 2 diabetes patients in hospital universiti sains malaysia

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of this study is to determine whether brazilian spinach supplementation effective in improving the nutritional status of type 2 diabetes mellitus patient.

background: vegetables are valuable health promotion foods because they contain vital nutrients such as vitamins, minerals, proteins, fibres and bio-functional components but are low in fat, sodium and calories as compared with many other foods. in terms of body fat, increase vegetable intake that consist of dietary fibre can play an important role in the regulation of body weight. therefore, the supplementation of dietary fibre intake from vegetable may have benefit in reducing the percentages of body fat. though, the clinical effect in human remains unclear and currently no study conducted in malaysia regarding the effectiveness of this plant towards blood sugar control. apart from that, lower intake of vegetable among malaysian, lower cost vegetable choices and higher availability of althernanthera sissoo (brazilian spinach) due to easy growth may benefit the diabetes patient. therefore, the investigators plan to conduct this study to determine the effectiveness of 12-weeks brazilian spinach supplementation on health outcomes among patients with type 2 diabetes especially in kelantan region. the investigators hypothesized that diabetes patients on supplementation of brazilian spinach would have significant differ in terms of anthropometry, biochemical, clinical, and dietary intake compared to control group. method: a single-center randomized, controlled, and two-arm parallel design clinical trial will be carried out in malaysia especially in kelantan region. this study enrols 100 patients from hospital universiti sains malaysia (husm) diagnosed with type 2 diabetes. diabetic patients who meet eligibility criteria will be randomly allocated to two groups, which are brazilian spinach treatment group and control group. both groups will be compared on the primary and secondary outcomes at baseline, 3, 6, and 12 weeks. discussion: the study will provide insights into the potential beneficial effect of brazilian spinach in type 2 diabetic patients. in addition, the therapeutic effect of brazilian spinach towards type 2 diabetes will reflect as a change of metabolite profile in serum.

Eligibility criteria:
inclusion criteria: * age between 30-65 years old * have confirmed diagnosed with type 2 diabetes mellitus of equal or more than 6 months * hba1c levels equal or more than 7% (within the last 3 months of recruitment) * on at least one oral hypoglycemic agent * agree not to take other herbal or nutritional supplements for the duration of study. exclusion criteria: * unable to tolerate to fiber especially vegetables * type 1 diabetes mellitus * pregnant * insulin treatment * severe diabetic complications including end-stage renal diseases, liver diseases or gastrointestinal diseases * on coagulant therapy (warfarin)
genetic causes of gestational diabetes in the emirati population

Conditions: Gestational Diabetes; GDM; Maturity-onset Diabetes of the Young; MODY

Summary: the study aims to identify the number of mody patients to be found among emirati women with gdm as the incidence and prevalence of monogenic diabetes among this group of patients is unknown. this will enable improvements in diagnostics, treatment and the counselling of these women.

the present study aims to perform systematic genetic screening of genes known as the cause of mody in women diagnosed with gestational diabetes to estimate the prevalence of mody. this is important to understand the extent to which monogenic diabetes is encountered for the first time during pregnancy. once women with mody developing gdm have been identified, biomarkers to identify these women can be found which will assist the clinical process of performing genetic screening in the right subset of patients. also for the women participating in the present study, this is of great importance as correct genetic diagnosis will provide them with the needed information to receive optimal treatment, correct plan for follow-up and a more accurate prognosis in relation to risk of future complication and therefore prevention of such.

Eligibility criteria:
inclusion criteria: * currently pregnant women diagnosed with gdm. * women with history of gdm (with negative gad/ia2 antibodies if results available). exclusion criteria: * women with positive gad/ia2 antibodies (if results available) * women genetically diagnosed as mody

Keywords: gdm mody genetic testing next generation sequencing ngs
comparing the pharmacodynamics and pharmacokinetics of explorative formulation of insulin degludec with insulin glargine in subjects with type 1 and type 2 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Summary: this trial is conducted in europe. the aim of this trial is to compare the pharmacodynamics (the effect of the investigated drug on the body) and pharmacokinetics (the exposure of the trial drug in the body) of insulin degludec (insulin 454), an explorative formulation, not similar to the proposed commercial formulation, with insulin glargine in subjects with type 1 and type 2 diabetes.


Eligibility criteria:
inclusion criteria: * glycosylated haemoglobin (hba1c) below or equal to 10 procent based on central laboratory results * specific inclusion criteria for subject with type 1 diabetes: * diagnosed with type 1 diabetes mellitus and treated with insulin for at least 12 months prior to screening * body mass index (bmi) between 18.0 and 27.0 kg/m\^2 (both inclusive) * specific inclusion criteria for subject with type 2 diabetes: * diagnosed with type 2 diabetes mellitus for at least 12 months prior to screening * treated with insulin for the past 3 months prior to screening * body mass index (bmi) between 22.0 and 35.0 kg/ m\^2 (both inclusive) exclusion criteria: * subject with a history of significant multiple drug allergies or with a known allergy or suspected allergy to the trial product or any medicine chemically related to the trial product,as judged by the investigator. * subject with a history of or presence of cancer * any condition that the investigator and/or sponsor feels would interfere with study * specific exclusion criteria for subject with type 2 diabetes: * therapy with oral antidiabetic drugs within the past 3 months prior to screening