Kornimate/medical-research-clean huggingface dataset:
an efficacy and safety 6-months study of synolis va 80/160 and synolis va 40/80 in the treatment of symptomatic knee osteoarthritis

Conditions: Osteoarthritis, Knee

Summary: multicentre, independent assessment study on synolis va 80/160 and synolis va 40/80 over a period of 24 weeks


Eligibility criteria:
inclusion criteria: * patient between 35 and 75 years old * patients with knee osteoarthritis. the diagnosis is based on the following american college of rheumatology (acr) classification: * knee pain * positive radiography (presence of osteophytes) * morning stiffness \< 30 min and/or crepitus while walking * symptoms related to knee osteoarthritis for at least 6 months * treatment failure (i.e. ineffective response) with analgesics and/or nsaids or intolerance to nsaids or low-grade opioids * kellgren-lawrence radiographic stage: i - iii (pre-inclusion radiography) * womac pain index score ≥ 40 mm (vas 0-100 mm) on the knee to be treated * contralateral knee pain \< 10 mm (vas) compared to treated knee * patient signed inform consent form- exclusion criteria: * inability to understand the study or language used to be informed/sign the consent * participation in another clinical trial within 4 weeks prior to the start of the trial, and commitment to non-participation within 4 weeks following the end of the trial * intraarticular injection of hyaluronic acid in target knee within the 6 months prior to inclusion * patient who has received an intra-articular (ia) or intra-muscular (im) steroid injection within the 3 months prior to inclusion or has taken oral corticosteroids within the month prior to inclusion * joint, bone, ligament, or any local or loco-regional surgery of the leg involved, arthroscopic operation on the target knee within the 3 months prior to inclusion * any recent trauma to the leg involved, including a sprain, dislocation within the 3 months prior to inclusion * rheumatoid arthritis, joint condition or any other inflammation and arthritis * lupus * dermatological disorder or any epidermal conditions that prevent an intraarticular injection * visible joint effusion of the target knee during physical examination evidenced by a protuberance or positive ballottement of the patella * evidence of a subchondral fracture, meniscal lesion, presence of bone or cartilage fragments, horizontal meniscal lesion tear (flap) in the target knee * osteonecrosis (1 or both knees) * daily dosage \> 101 mg of acetylsalicylic acid as part of cardiovascular preventive treatment (antithrombotic). if dose \< 101 mg, must be maintained during the study * known intolerance/hypersensitivity/allergy to any of the components in either product, synolis va * fibromyalgia * patient of childbearing potential, pregnant or breast-feeding known at inclusion or in the planning phase during the study unless willing to use contraceptives through the whole duration of the study * excessive and repeated consumption of alcohol or illicit substances * any medical condition that may interfere with the proper conduct of the study (including any surgery or hospitalisation)

Keywords: osteoarthritis knee osteoarthritis hyaluronic acid
efficacy and safety evaluation of alirocumab in patients with heterozygous familial hypercholesterolemia or high cardiovascular risk patients with hypercholesterolemia on lipid modifying therapy (odyssey japan)

Conditions: Hypercholesterolemia

Summary: primary objective: to demonstrate the reduction of low-density lipoprotein cholesterol (ldl-c) by alirocumab as add-on therapy to stable daily statin therapy with or without other lipid modifying therapy in comparison with placebo after 24 weeks of treatment in heterozygous familial hypercholesterolemia (hefh) or high cardiovascular risk participants with hypercholesterolemia. secondary objectives: * to evaluate the effect of alirocumab in comparison with placebo on ldl-c after 12 weeks of treatment. * to evaluate the effect of alirocumab on other lipid parameters. * to evaluate the long-term effect of alirocumab in comparison with placebo on ldl-c after 52 weeks of treatment. * to evaluate the safety and tolerability of alirocumab. * to evaluate the development of anti-alirocumab antibodies. * to evaluate the pharmacokinetics of alirocumab.

total duration per participant of approximately 63 weeks (14 months) (screening: 3 weeks, double-blind treatment period: 52 weeks, and follow-up period: 8 weeks).

Eligibility criteria:
inclusion criteria: participants with heterozygous familial hypercholesterolemia or non-familial hypercholesterolemia who were not adequately controlled with a stable daily dose of statin with or without other lipid modifying therapy, at stable dose prior to the screening visit (week -3). exclusion criteria: 1. ldl-c \<100 mg/dl (\<2.59 mmol/l) at the screening visit in participants with heterozygous familial hypercholesterolemia or in participants with non-familial hypercholesterolemia who had a history of documented coronary heart disease as described in japan atherosclerosis society (jas) guidelines for prevention of atherosclerotic cardiovascular diseases 2012. 2. ldl-c \<120 mg/dl (\<3.10 mmol/l) at the screening visit in participants with non-familial hypercholesterolemia who had a history of documented diseases or other risk factors as categorized in primary prevention category iii as described in jas guidelines for prevention of atherosclerotic cardiovascular diseases 2012. 3. not on a stable daily dose of lipid modifying therapy (including statin) within 4 weeks prior to the screening visit or between screening and randomization visits. 4. age \<20 years at the screening visit. the above information is not intended to contain all considerations relevant to a participants' potential participation in a clinical trial.
assessment of left-sided cardiac sparing through the use of 3-dimensional surface matching-based deep inspiration breath hold and active breathing control

Conditions: Left-Sided Breast Cancer

Summary: the standard treatment for breast cancer is surgery followed by adjuvant breast radiation therapy in most cases. for left sided breast cancers, the heart dose delivered by the radiation treatment is often of particular concern. in order to spare the heart, different strategies are currently available, including active breathing control (abc) and voluntary deep in inspiration breath hold (dibh) (both strategies are currently being used at our centre). to perform accurate heart-sparing treatments, it is important to ensure that patients are positioned consistently. one available approach is through surface imaging which tracks the position of a portion of the skin surface, known as the alignrt system (visionrt ltd, london, uk).


Eligibility criteria:
inclusion criteria: * women with diagnosis of left-sided breast malignancy * women who require left chest wall or breast irradiation status post mastectomy or lumpectomy * treatment with modified wide tangents to include imcs * treatment with four-field technique * age \>18 years * performance status ecog \<3 * patient must be able to maintain a 30 second breath hold * conventional chest wall or breast radiation delivery dose of 50gy/25 or hypofractionated chest wall/breast radiation delivery dose of 42.56gy/16 with or without a boost exclusion criteria: * right sided breast cancer patients * treatment with partial breast irradiation * previous left breast/chest wall irradiation * locally advanced breast cancer * pregnant patients * unable to follow commands
a brief study to evaluate the safety, tolerability, and blood levels of multiple doses of pf-044467943 or placebo in combination with donepezil in subjects with mild to moderate alzheimer's disease

Conditions: Alzheimer's Disease

Summary: the purpose of the study is to evaluate the safety of pf-04447943 when given in combination with donepezil in subjects who have alzheimer's disease. the study will also evaluate the absorption and distribution of both pf-04447943 and donepezil.


Eligibility criteria:
inclusion criteria: * subjects must have alzheimer's dementia with a mini mental state examination score between 18-26, inclusive. * subjects must have a reliable caregiver. * subjects must be on aricept * memantine is allowed if subjects are on a stable dose * subjects must be in reasonably good health, based on medical history, physical examination, vital signs, and ecg, with no serious or unstable disease within the past 3 months. exclusion criteria: * subjects with clinically significant heart disease cannot participate. * subjects with a past or current history of seizures cannot participate.

Keywords: phase 1 alzheimer's disease donepezil
changes in tactile perception in people with segmental exclusion syndrome

Conditions: Upper Limb Exclusion Syndrom

Summary: segmental exclusion syndrome is characterised by the non-use or under-use of a limb segment, most oftenly reported in the distal part, following an injury, without affecting the central nervous system. this syndrome has an important negative impact on the daily life of affected subjects; however, it remains poorly studied, particularly in terms of pathophysiology, and its management is still not specific. currently, the main pathophysiological hypothesis is an alteration of the afferences related to a dysfunction of the sensorimotor loop. an hypothesis is that this dysfunction could concern the level of tactile perception and that the damage to the distal light touch receptors could play a role in the pathophysiology. the protocol is based on the performance of tests that explore different aspects of light touch: passive, active, dynamic and static sensitivity.


Eligibility criteria:
inclusion criteria: * no history of upper limb involvement * confirmed diagnosis of segmental exclusion \> 3 months after injury (2 items assigned to 400 points) * able to understand simple orders exclusion criteria: * central neurological involvement after the initial or pre-existing injury * truncal nerve damage * presence of psychiatric pathology * communication and/or comprehension disorders * presence of other pathology that may lead to sensory disorders (complicated diabetes, ductal syndrome, ...)
efficacy and safety of evogliptin when added to ongoing metformin and dapagliflozin combination therapy in patients with type 2 diabetes who have inadequate glycemic control

Conditions: Type2 Diabetes

Summary: a multicenter, double-blind, placebo-controlled, randomized, parallel, phase iii clinical trial to evaluate the efficacy and safety of evogliptin when added to ongoing metformin and dapagliflozin combination therapy in patients with type 2 diabetes who have inadequate glycemic control


Eligibility criteria:
inclusion criteria: * patients with type ii diabetes mellitus aged 19 years or older * subjects who performed dual therapies (complex allowed) for one of the following, along with meals and exercise therapy 1. subjects who are receiving metformin ≥ 1000 mg/d and dapagliflozin 10 mg/d at the same dose for at least 8 weeks prior to the screening visit 2. subjects who are receiving metformin ≥ 1000 mg/d and sglt-2 inhibitor except for dapagliflozin at the same dose for at least 8 weeks prior to the screening visit * subjects with 7.0%≤hba1c≤10.5% at screening visit * subjects with fasting plasma glucose ≤ 270mg/dl at screening visit * subjects with 18.5kg/m2≤bmi≤40kg/m2 at screening visit exclusion criteria: * patients with type 1 diabetes, secondary diabetes, gestational diabetes, diabetic ketoacidosis, diabetic coma, pre-coma, lactic acidosis, and acute or chronic metabolic acidosis * patients with hypopituitarism or adrenal insufficiency, pulmonary infarction, severe pulmonary dysfunction and other hypoxemia * patients with severe infectious disease or severe traumatic systemic disorders * end stage renal disease or dialysis patients * patients with galactose intolerance, lapp lactase deficiency, glucose-galactose malabsorption * subjects with liver cirrhosis, chronic active hepatitis b or c, cholecystitis, acromegaly, asthma or major skin allergies
'dialogue and guidance' - a policy intervention for improved ohs among workplaces with wea violations

Conditions: Occupational Diseases; Occupational Injuries; Safety Issues

Summary: with the aim to inspire and motivate workplaces in their work to prevent and reduce occupational health and safety hazards, the danish working environment authority (wea) developed the intervention 'dialogue and guidance' aimed at workplaces receiving notices (prohibition notice, immediate improvement notice and notice with time limit) from wea during inspections. at present, wea gives dialogue and guidance as standard practice during wea inspections to all workplaces receiving a notice with the purpose to help workplaces resolve the occupational health and safety problem that led to the notice. in the intervention 'dialogue and guidance' the experimental groups are receiving additional dialogue and guidance at a subsequent meeting (over the telephone or physical presence) that takes place after the inspection and after the deadline for appealing the notice has expired. the control group is receiving dialogue and guidance during inspection as usual. the aim of this rct study is to evaluate the policy-developed intervention with additional 'dialogue and guidance' in regards to the effect on motivation and priority of occupational health and safety work at the workplace after 6 months follow-up and for wea notices by next wea inspection (approx. follow-up by 12-18 months). study is risk assessed and approved under danish data protection agency via the national research centre for the working environment's umbrella approval.


Eligibility criteria:
subjects under inspection are workplaces, and respondents of the questionnaires are the workplace manager and a work environment representative or shop steward. inclusion criteria: • workplaces (production units) who receives a wea notice during wea inspection through the period of intervention. the following wea notices are included: * immediate improvement notice * notice with time limit (material) exclusion criteria: * companies with 0-1 employees. * production units from the construction industry met on temporary worksites (such as construction sites) that have more than one employee and does not have a certified occupational health and safety management system. * companies receiving notices only about issues in the formal/procedural aspects of the work environment (such as flaws in the workplace risk assessment) and no other notices. * companies receiving more than four reactions from wea at the inspection (as these receive a competency notice and are not included in the study). * companies that receive a prohibition notice by the wea inspector due to severity of work environment violations. * a wea improvement notice is not eligible for inclusion in the study if the workplace has entered into a collaborative agreement with wea on improvement of the issue, or if they have received a competency notice on the wea issue. * companies receiving wea inspections in relation to initiatives targeting social dumping
tributyrin: time course & efficacy to improve health & performance

Conditions: Metabolite Concentration; Gut Permeability; Inflammation; Sleep; Performance

Summary: the purpose of this study is to determine if tributyrin supplementation improves metabolite concentrations, overall health biomarkers, and performance in sedentary men and women. the study would further understand the potential usage of tributyrin as a health and performance increasing supplement through improving gut and immune health, sleep, and performance as well as reduce inflammation. participants will supplement for tributyrin for 4 weeks and complete fecal metabolite measures, cardiovascular evaluation, sleep assessment, and exercise testing as well as provide blood samples.


Eligibility criteria:
inclusion criteria: * age: 30-50 years * sedentary (\<150 minutes of aerobic exercise per week) exclusion criteria: * chronic, uncontrolled metabolic, cardiovascular, gastrointestinal, or hepatic disease * consumption of supplements known to impact the microbiome, hydration status, core temperature, or exercise performance * experienced previous heat illness * known injuries that limit exercise * bmi ≥ 40 kg/m\^2 * pregnant
neuropsychological impact of hospitalization on intubated, ventilated and sedated icu patients

Conditions: Stress Disorders, Post-Traumatic; Depression

Summary: this is a prospective, single-center, pilot, cohort study. the first phase of this study is observational and the usual care of patients is maintained during the icu stay, except for an interview with a psychologist preceding patient discharge. a phone interview at 2 months and a visit with a psychologist at four months after icu discharge are specific to the study. the main objective of this study is to make a first estimate of the percentage of patients (ci = +- 10%) with cognitive impairment at four months after icu discharge. the presence / absence of cognitive impairment will be determined by the d2 test.

the secondary objectives of this study are: a. to study the potential links between cognitive impairment and quality of life 4 months after discharge from the intensive care unit. b. to study the associations between variables measured during hospitalization. is there "clustering" among certain symptoms during hospitalization? c. to study the associations between variables measured at two and four months after icu discharge. is there clustering among these symptoms? d. to study potential risk factors for cognitive problems at 4 months after icu discharge. e. if objective c determines the presence of clusters, is the presence / absence of these clusters related to the variables (or clusters of variables) measured during hospitalization? f. to study potential risk factors for poor quality of life at 4 months:

Eligibility criteria:
inclusion criteria: * the patient (or his/her "trusted person") must have given his/her informed and signed consent * the patient must be insured or beneficiary of a health insurance plan * the patient is available for a telephone interview at 2 months after icu discharge, and for a follow-up visit at 4 months after icu discharge * patient admitted to the icu and intubated and ventilated for at least 48 hours exclusion criteria: * the patient is currently participating in or has participated in another study (within the past 3 months) that might influence the results of the current study * the patient is under judicial protection, under tutorship or curatorship * the patient refuses to sign the consent * it is impossible to correctly inform the patient * the patient is pregnant, parturient, or breastfeeding * the patient has a contra-indication for a treatment used in this study * patient admitted to intensive care with sedation started for more than 24 hours * patient with neurological or psychiatric (cognitive) disorders * patient admitted for cardiac arrest * patient admitted for stroke * patient admitted for cervical trauma \> c6 * patient presenting with tracheotomy accompanied by long-term mechanical ventilation * moribund patient or with little hope of survival beyond 48 hours * patients for whom a limitation or termination of care is considered * mccabe score = 0 * knauss scale = c or d

Keywords: cognitive disorders quality of life intensive care
effect of efpeglenatide on cardiovascular outcomes

Conditions: Type 2 Diabetes Mellitus

Summary: primary objective: to demonstrate that efpeglenatide 4 and 6 mg was noninferior to placebo on 3-point major adverse cardiac events (mace) in type 2 diabetes mellitus (t2dm) participants at high cardiovascular (cv) risk. secondary objectives: to demonstrate that efpeglenatide 4 and 6 mg was superior to placebo in t2dm participants with high cv risk on the following parameters: * 3-point mace. * expanded cv outcome. * composite outcome of new or worsening nephropathy. to assess the safety and tolerability of efpeglenatide 4 and 6 mg, both added to standard of care in t2dm participants at high cv risk.

the study duration per participant was up to approximately 36 months.

Eligibility criteria:
inclusion criteria: * t2dm with glycosylated hemoglobin (hba1c) greater than (\>) 7 percentage. * age 18 years or older who met at least one of the cardiovascular disease criteria or age 50 years (male), 55 years (female) or older with glomerular filtration rate greater than or equal to 25 and less than 60 milliliters per minute and at least had one cardiovascular risk factor. * female participants agreed to follow contraceptive guidance. * signed written informed consent. exclusion criteria: * clinically relevant history of gastrointestinal disease associated with prolonged nausea and vomiting. * history of chronic pancreatitis or acute idiopathic pancreatitis or diagnosis of any type of acute pancreatitis within 3 months prior to screening. * personal or family history of medullary thyroid cancer. * hypertension (with a systolic blood pressure \>180 millimeters of mercury \[mmhg\] and/or diastolic blood pressure \>100 mmhg). * hospitalization for hypertensive emergency within 3 months prior to randomization. * planned coronary procedure or surgery after randomization. * no documented ophthalmologic exam with fundoscopy within 6 months prior to randomization. * retinopathy or maculopathy with treatment, either recent (3 months prior to randomization) or planned during the study. * treated with any glucagon-like peptide-1 receptor agonist product alone (eg, exenatide, liraglutide, lixisenatide, albiglutide, dulaglutide, semaglutide) or in combination within 3 months prior to screening. * use of any dipeptidyl peptidase 4 inhibitor within 3 months prior to screening. * antihyperglycemic treatment had not been stable within 3 months prior to screening. the above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
expression of nis protein and mrna in thyroid tumors

Conditions: Tumors

Summary: the uptake of iodide by thyroid cells requires the expression of sodium iodide symporter (nis). thyroid benign and malignant tumors have low iodide uptake activity. previous studies of nis expression with rt-pcr and immunohistochemistry showed divergent data. nis protein was overexpressed in thyroid cancer. the aim of this study was to investigate the nis transcript levels and its presence and localization in 30 samples of thyroid tumors (14 benign and 16 malignant) and in their surrounding non-tumoral tissues (nt), by real time rt-pcr and immunohistochemistry, respectively. our results revealed lower gene expression in 78.6% of the benign tumors and 100% of the carcinomas when compared with the nt samples, using ghpdh as a housekeeping gene. immunohistochemical staining revealed presence of nis protein in 100% of the non-tumoral samples, 100% of the benign tumors and 93.75% of the malignant tumors. nis protein was identified at basolateral membrane in 23.3% of non-tumoral samples, 14.3% of benign and 12.5% of malignant tumors. stronger cytoplasmatic immunostaining of nis protein was detected in 64.3% of benign tumors and in 87.5% of malignant tumors when compared to nt. association between low gene expression and strong cytoplasmatic immunostaining was found in 50% of benign tumors and 87.5% of malignant tumors. we concluded that the reduced nis gene expression in thyroid tumors associated with strong intracytoplasmatic staining may be due to its incapacity to migrate to cellular membrane.

the aim of this study was to quantify nis transcript levels by real time pcr and to determine the presence and cellular localization of nis protein by immunohistochemistry, in benign and malignant thyroid tumor cells and to compare with their paired surrounding non-tumoral cell. nis expression was also compared to that of the tshr

Eligibility criteria:
inclusion criteria: * patients with thyroid tumors undergoing surgery for total or partial thyroidectomy exclusion criteria: * pregnancy

Keywords: nis thyroid adenoma thyroid cancer iodine uptake expression