Kornimate/medical-research-clean huggingface dataset:
evaluation of efficacy and safety of omacor (omega-3-acid ethyl esters) as add-on therapy in hypertriglyceridemic subjects treated with antara (fenofibrate) followed by an 8-week extension

Conditions: Hypertriglyceridemia

Summary: the purpose of om5/lov111859 was to evaluate efficacy and safety of omacor (omega-3-acid ethyl esters) as add-on therapy to antara (fenofibrate) and diet for the treatment of patients with very high triglycerides. the purpose of both om5x/lov111860 was to assess the continued efficacy and safety of adjunctive lovaza (omega-3-acid ethyl esters) therapy in hypertriglyceridemic subjects treated with fenofibrate in lowering serum triglyceride (tg) levels.

three studies comprise this om5 program * study om5 / lov111859 (double-blind study) and om5x / lov111860 (1st open-label extension) are part of this listing on clinicaltrials.gov - nct00246636. * study om5xx / lov111821 (2nd open-label extension) is listed as a separate listing on clinicaltrials.gov - nct00891293

Eligibility criteria:
for om5/lov111858 - inclusion criteria: * men and women ages 18-79 years, inclusive * triglyceride levels between 500 mg/dl and \<1300 mg/dl * body mass index between 25 and 43 kg/m2 * willingness to follow a low-saturated fat diet during the study period and maintain current physical activity level * normally active and in good health on the basis of medical history, brief physical examination, electrocardiogram, and routine laboratory tests * provide written informed consent and authorization for protected health information disclosure exclusion criteria: * sensitivity to fibrate drugs or omega-3 fatty acids * lipoprotein lipase impairment or apo c-2 deficiency or type iii hyperlipidemia * history of pancreatitis * recent history of certain kidney, liver, lung, or gastrointestinal disease or cancer (except non-melanoma skin cancer) * poorly controlled diabetes mellitus * type 1 diabetes * pregnant or lactating females. women of childbearing potential who are not using a medically approved method of contraception. * use of certain types of hormones, anticonvulsant drugs, immunologic drugs, antibiotic, antifungal and antiviral drugs, and cardiac drugs * use of isotretinoin (accutane) * use of warfarin (coumadin) for om5x/lov111859 - subjects were included in the study if they met the following criteria: 1. satisfied all inclusion and exclusion criteria prior to and throughout the previous om5 study or had a corresponding approved protocol deviation 2. successfully completed the previous om5 double-blind study to week 8 3. provided written informed consent on or before the week 8 clinic visit of the om5 double-blind study (i.e., visit 1x of the om5x extension study)

Keywords: very high triglycerides omega-3-acid ethyl esters fenofibrate lovaza
effects of therapeutic ultrasound versus shockwave therapy in medial tibial stress syndrome in recreational runners

Conditions: Medial Tibial Stress Syndrome

Summary: this project was a randomized control trial conducted to check the effects of therapeutic ultrasound versus shockwave therapy on pain , range of motion and function in recreational runners with medial tibial stress syndrome so that we can formulate a better and most effective regime for treatment of medial tibial stress. duration was of 6 months, convenient sampling was done, subject following eligibility criteria from ghurki trust teaching hospital, horizon hospital and surgimed hospital. group a participants were given baseline treatment along with shockwave and group b were given baseline treatment along with therapeutic ultrasound. assesment was done at baseline and at 2nd week and 6th week post-interrvention . assessment was done via, numeric pain rating scale(nprs), lower extermity functional scale lefs ) and goniometric measurements of shoulder ranges, data was analyzed by using spss version 26.

medial tibial stress syndrome (mtss) is a common low leg injury. it is described as activity-induced pain along posterior medial border of leg approximately for 5 cm. most commonly reported by runners and military personnel. incidence of mtss ranges between 13.6% to 20% in runners. significant increase in loading activities or rigorous exercise causing high impact like skiping, jogging can induce mtss which leads to stress fracture of tibia. various risk factors are associated with the incidence of medial tibial stress syndrome which includes both intrinsic and extrinsic factors. current study has involved comparison of therapeutic ultrasound versus shockwave therapy as there is limited knowledge about comparison of therapeutic ultrasound versus shockwave therapy.

Eligibility criteria:
inclusion criteria: * both male and female * pain at distal 2/3 of tibia * previous history of mtss * recreational runner exclusion criteria: * history of lower limb fracture * any lower limb surgical history * any malignancy * professional athlete * cardiopulmonary insufficiency

Keywords: shock wave medial tibial stress syndrome ultrasound
effects of rhythmic auditory cueing on stepping in place in patients with parkinson's disease

Conditions: Parkinson Disease

Summary: patients with parkinson's disease have internal rhythm dysfunction, which may affect the rhythmic movements such as walking. poor regularity of the rhythmic movement may lead to freezing of gait. this study will apply rhythmic auditory cues on the stepping-in-place training and the investigators will examine if the behavior and neuroelectrophysiology would change after auditory cueing training. the investigators hypothesize the variation of rhythmic movements such as walking and stepping-in-place will be reduced, and the cortical excitability would be modulated after training.

parkinson's disease is a common neurodegenerative disease and movement disorder. due to the degeneration of basal ganglia, patients with parkinson's disease also demonstrate internal rhythm dysfunction, thus will lead to difficulty in rhythmic movements such as ambulation. for improving the rhythmic movement problem, auditory cues are often used in clinical setting and shows benefits in ambulation and freezing problems. previous studies often use finger tapping test and ambulation to assess the rhythmic movement problem. no study uses stepping in place movements as a test to examine rhythmic problem. little study investigates the effects of auditory cues on brain cortical excitability. in this cross-over study, participants will receive 2 times of training include stepping-in-place exercise with and without auditory cues in random orders. auditory cues are given via the metronome. there is one-week wash-out period between two trainings. movement tests such as walking and stepping-in-place and transcranial magnetic stimulation (tms) are carried out before and after each training. the investigators hypothesize the variation of rhythmic movements such as walking and stepping-in-place will be reduced more, and the cortical excitability would be modulated after the training with auditory cues, comparing with the other training without auditory cues.

Eligibility criteria:
\[patients with parkinson's disease\] inclusion criteria: * diagnosed with idiopathic parkinson's disease * no hearing impairment * able to walk independently for at least 10m * able to follow command (mmse \>=24) \[healthy subjects\] * no hearing impairment * able to walk independently for at least 10m * able to follow command (mmse \>=24) exclusion criteria: * with other neurological diseases or psychological diseases * dementia * family history of epilepsy * history of head trauma, surgery, or metal implants * having pacemaker or other electrical stimulators * history of syncopes or frequent migraines

Keywords: parkinson's disease auditory cues step in place transcranial magnetic stimulation cortical excitability
long-term followup and/or thalidomide maintenance therapy for patients enrolled on clinical trial 20030165

Conditions: Mantle Cell Lymphoma; Non-Hodgkin's Lymphoma

Summary: the study seeks to provide long-term follow-up and/or to offer continued maintenance thalidomide (thalomid) therapy to those patients enrolled in 20030165. patients will be followed until withdrawal of consent, or death.


Eligibility criteria:
inclusion criteria: 1. enrolled on the 20030165 clinical trial. 2. ability to understand and willingness to sign a written informed consent document. exclusion criteria: 1. patients who were discontinued from 20030165 for any reason prior to the completion of protocol-specified treatment (e.g. withdrawal of consent). 2. uncontrolled, intercurrent serious illness including but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, and/or cardiac arrhythmia likely in the judgment of the pi to interfere with clinical study requirements. 3. psychiatric illness/condition likely in the judgment of the pi to limit compliance with clinical study requirements.
neck division level and postoperative pancreatic fistula after pancreaticoduodenectomy

Conditions: Pancreatoduodenectomy

Summary: brief summary:\* aim of the study : to evaluate if the neck division level significantly influences the postoperative pancreatic fistula rate of pancreatico-jejunal anastomosis after pancreatoduodenectomy. methods : patients who underwent oncologic or non-oncologic pancreatoduodenectomy between 01 january 2009 and 04 april 2018 will be included in this retrospective analysis. two independent radiologists will measure the distance between the left side of the portal vein and the remnant pancreatic stump on post operative ct scan, blindly for postoperative course. this new variable will be integrated in a logistic regression model in addition to well known risk factors of popf.

the pancreatic neck is an anatomical area mainly vascularized by the arterial network derived from the gastroduodenal artery and branches of the superior mesenteric artery running in the pancreatic head. the neck arterial blood supply is probably reduced after pancreatoduodenectomy due to the ligation of gastroduodenal artery and collaterals of superior mesenteric artery. postoperative pancreatic fistula (popf) is the main complication after pancreatoduodenectomy. popf has an estimated rate of 15 to 30%. so, this complication is frequent and could be lethal. several studies have been driven to identify risks factors of popf but there are no actual data on the impact of the neck division level and neck vascularization on popf. by considering the level of neck division is variable, the investigator hypothesize that a long remnant neck, is a risk factor of popf after pancreatoduodenectomy with pancreatojejunal anastomosis. the aim of the present study is to integrate this new variable in a logistic regression model in addition to well known risk factors of popf.

Eligibility criteria:
inclusion criteria: * elective pancreatoduodenectomy with pancreatojejunal anastomosis whatever the indication * age \> 18 y.o. exclusion criteria: * past history of pancreatic surgery * patient who reject the study protocol

Keywords: pancreatic fistula morbidity risk factors benign or malign pathology
health related quality of life after intensive care for sepsis, a national cohort study.

Conditions: Sepsis; Septic Shock; Sepsis, Severe

Summary: the study aims to map the health-related quality of life (hrqol) after intensive care for sepsis with the hypothesis that it will be lower than that in the general population. the investigators also want to identify factors that are associated with low hrqol, to see if those are available for interventions from the health care system and society to improve quality of life after treatment for sepsis in the intensive care unit (icu).

background sepsis is a common condition in intensive care units leading to severe illness with a high mortality. it can also lead to significant disability for the individuals after recovery. objective the investigators aim to study how intensive care for/with sepsis impacts the hrqol and, if possible, identify improvable factors in the treatment and rehabilitation. method this is a cohort study on all icu patients with sepsis registered in the swedish intensive care registry (sir) as well as age and gender matched population controls. the primary outcome variable hrqol will be assessed by rand-36. the investigators assess functional recovery by sick leave free days. sir provides post-icu follow-up data on rand-36. the investigators will merge these data with data on comorbidity from the national patient register, causes of death from the national death registry, socioeconomic factors from statistics sweden, as well as the data on social benefits from the swedish social insurance agency. the main analysis compares rand-36 from sepsis patients with population controls over time. the investigators will also compare the complete sepsis cohort's burden of inability to work before and sick leave free days after sepsis with matched population controls. additionally, the investigators will describe the complete sepsis cohort's burden of disease measured with charlson comorbidity index against matched population controls. ethics the study has ethical permission from swedish ethical review authority, nos 2022-00445-01 and 2022-07264-02. eligibility all patients over 18 with sepsis or septic shock diagnosis admitted to icu between january 1st 2008 until february 28th 2020 . study population nationwide registry of patients admitted to icu treatment in sweden. intervention/treatment no active intervention, but the study subjects have had intensive care for sepsis or septic shock. official title health related quality of life after intensive care for sepsis, a national cohort study.

Eligibility criteria:
inclusion criteria: * admitted to an icu in sweden that reports to the swedish icu register * admitted between january 1st 2008 until february 28th 2020 * admitted for sepsis or septic shock and / or * received sepsis or septic shock diagnosis during icu stay exclusion criteria: * age under 18

Keywords: rand-36 icu-treatment health-related quality of life hrqol icu-outcome sf-36
immunogenicity and safety of meningococcal acyw135 polysaccharide conjugate vaccine in volunteers aged from 3 to 35 months

Conditions: Meningitis, Meningococcal

Summary: the purpose of this study is to evaluate the immunogenicity and safety of meningococcal acyw135 polysaccharide conjugate vaccine in healthy volunteers aged from 3 months to 35 years.


Eligibility criteria:
inclusion criteria: * people aged 3-35 months; * subject who has not been vaccinated with meningococcal group a and c conjugate vaccine, meningococcal group a polysaccharide vaccine and meningococcal group a and c and haemophilus b conjugate vaccine at the aged of 3-11 months, and who have't given boost immunity above 1 year old, and they all meet the physical examination requirements of the project; * infants aged 3-11 months should be full-term (37-42 weeks of gestation) and their birth weight should meet the requirements (2500g ≤ body weight ≤ 4000g); * the guardian signs the informed consent form; * the guardian and his family agree to comply with the requirements of the clinical trial protocol; * subject who had no history of other live vaccines within 14 days before vaccination and no history of other inactivated vaccines within 7 days; * axillary body temperature ≤ 37.0 ℃. exclusion criteria: * history of severe allergic reactions requiring medical intervention (such as swelling of mouth and throat, dyspnea, hypotension or shock); * have a history of allergy to the vaccine or vaccine ingredients (especially those allergic to tetanus toxoid), or have a history of other serious adverse reactions to the vaccine; * a clearly diagnosed history of thrombocytopenia or other coagulation disorders that may cause contraindications to intramuscular injection; * abnormal production process, asphyxia rescue history, or congenital malformation, developmental disorder or serious chronic disease; * has serious cardiovascular, liver and kidney diseases or congenital abnormalities and hiv infection; * suffer from encephalopathy, uncontrolled epilepsy, convulsion and other progressive nervous system diseases; * acute disease, severe chronic disease, acute attack of chronic disease and fever (axillary body temperature ≥ 38.0 ℃) in the past 3 days; * plan to participate or be participating in any other drug clinical research; * the interval between the first dose of test vaccine and meningococcal group a polysaccharide vaccine is less than 28 days; * according to the judgment of the investigator, the subject has any other factors that are not suitable for participating in the clinical trial.
pharmacokinetics study of rivaroxaban and apixaban in cancer patients

Conditions: Anticoagulants and Thrombotic Disorders

Summary: direct oral anticoagulants (doacs) are now recommended as a first-line option in cancer patients with venous thromboembolism or atrial fibrillation. however, current international clinical practice guidelines and product inserts suggest caution and/or avoidance in using doacs in case of potential potential drug-drug interactions (ddi), including ddi with anticancer therapies. indeed, potential important ddis can affect the efficacy and safety of doacs and/or anticancer therapies and/or other interfering medications in these patients. data about the pharmacokinetics (pk) of doacs in cancer patients are scarce. by using a pk approach, this study aims : * to describe the pk profile of rivaroxaban and apixaban in adult cancer patients with venous thromboembolism or atrial fibrillation from a real-world setting * to identify factors (age, weight, renal function, co-morbidities, etc) influencing the pk profile of rivaroxaban and apixaban in adult cancer with venous thromboembolism or atrial fibrillation from a real-world setting.

direct oral anticoagulants (doacs) are now recommended as a first-line option in cancer patients with venous thromboembolism or atrial fibrillation. however, current international clinical practice guidelines and product inserts suggest caution and/or avoidance in using doacs in case of potential potential drug-drug interactions (ddi), including ddi with anticancer therapies. indeed, potential important ddis can affect the efficacy and safety of doacs and/or anticancer therapies and/or other interfering medications in these patients. data about the pharmacokinetics (pk) of doacs in cancer patients are scarce. by using a pk approach, this study aims : * to describe the pk profile of rivaroxaban and apixaban in adult cancer patients with venous thromboembolism or atrial fibrillation from a real-world setting * to identify factors (age, weight, renal function, co-morbidities, etc) influencing the pk profile of rivaroxaban and apixaban in adult cancer with venous thromboembolism or atrial fibrillation from a real-world setting

Eligibility criteria:
inclusion criteria: * male or female subjects with age ≥ 18 years * cancer (other than basal-cell or squamous-cell carcinoma of the skin), either active or diagnosed within 6 months prior to inclusion * confirmed symptomatic or venous thromboembolism or confirmed atrial fibrillation * patients affiliated with a health insurance system * able to provide written informed consent. exclusion criteria: * age \<18 years * pregnancy or breastfeeding * patients not affiliated with a health insurance system * patient subject to a measure of protection * legally protected adults * life expectancy \< 3 months
biomedical innovation for facial bone reconstruction in oncology: bioface pass a medico-economic study describing the standard pathway of patients treated by free bone flap

Conditions: Head and Neck Cancers

Summary: the purpose of this study is to describe the standard of care pathway of patients treated by free bone flap for facial mandibullar or maxillar reconstruction after surgery for head and neck cancers.

curative management of head and neck cancers frequently requires an interrupting mandibulectomy or maxillectomy. surgery may involve resection of anatomical structures such as jaw or maxilla. the use of free vascularized fibula or scapula flap is the "gold standard" for mandibular and maxillary reconstruction but remains suboptimal as resulting in difficulty in speaking, swallowing, and disfigurement. the bioface project, funded by "appel à projet -recherche hospitalo-universitaire en santé (rhu)" number 6 france 2023, aims to develop a new biomaterials based device to reconstruct these structure after surgery. in addition to the clinical benefits, this project aims to demonstrate the medico-economic benefits of the bioface solution. therefore, the bioface pass study has been designed to describe standard of care pathways of patients treated by free bone flap for facial reconstruction after surgery for head and neck cancer. direct medical and non-medical costs, and daily allowance 12 months after the end of treatment, and quality of life will be recorded at the inclusion, 3 and 12 months. from the hospital perspectives, production costs will be recorded using the micro-costing approach.

Eligibility criteria:
inclusion criteria: * patient with oral cavity cancer or maxillary and/or oropharynx cancer * eligible for treatment by surgery requiring a mandibulectomy or segmental maxillectomy and having a free bone flap for facial reconstruction. * patient whose disease is classified stage ct4a, n0 to n3, m0 * treatment with a feasible curative aim (no contraindication to optimal treatment such as surgery or chemotherapy at a curative dose) * age greater than or equal to 18 years * patient affiliated to a social security scheme in france * patient having given written informed consent non-inclusion criteria: * patient having any situation considered by the doctor as a reason for non-inclusion such as stenosis of the leg tripod not allowing reconstruction by fibula, one or more comorbidity(s) not allowing reconstruction by free bone flap or making this reconstruction too much risk * patient having had previous radiotherapy * patient with severe coagulation disorders * patients deprived of liberty or under legal protection regime (curatorship and guardianship, safeguard of justice)

Keywords: mandibullar or maxillar reconstruction care pathway free bone flap medico-economic study
imaging biomarkers in als

Conditions: Amyotrophic Lateral Sclerosis; Primary Lateral Sclerosis

Summary: the purpose of the study is to determine if we are able to find one or more biomarkers of amyotrophic lateral sclerosis (als) and primary lateral sclerosis (pls) using magnetic resonance imaging (mri) scans at different levels, 3 tesla (3t) and 7 tesla (7t). a biomarker is a measurable characteristic that can be used as an indicator of a particular disease state. identifying biomarkers of a disease can lead to a better understanding of the disease as well as improved treatments. this study will enroll patients with als, pls, and healthy controls.


Eligibility criteria:
inclusion criteria: * 21 to 75 years of age inclusive. * willing and able to give signed informed consent that has been approved by the institutional review board (irb). als patients: * a clinical diagnosis of possible, laboratory-supported probable, probable, or definite als, according to a modified el escorial criteria. exclusion criteria: * diagnosis of other neurodegenerative diseases (parkinson disease, alzheimer disease, etc). * clinically significant history of unstable medical illness (unstable angina, advanced cancer, etc) over the last 30 days. * inability to undergo mri scanning, including but not limited to unable to remain still in an mri scanner for more than 30 minutes, claustrophobia, presence of paramagnetic substances or pacemakers in body, weight over 300 lbs, or in the opinion of the investigator, if there is a strong likelihood that the subject would not be able to lie flat comfortably for 75-90 minutes. * the subject requires assistance to ambulate or climb stairs, unless in the opinion of the investigator, and based upon the subject's rate of disease progression, the subject is likely to be able to participate in the mri screening 12 months after enrollment.