Kornimate/medical-research-clean huggingface dataset:
ascension® humeral resurfacing arthroplasty follow-up study

Conditions: Shoulder Arthritis Osteoarthritis; Rheumatoid Arthritis Shoulder; Acquired Deformity of Head; Post-traumatic Arthrosis of Other Joints, Shoulder Region

Summary: it is a non-randomized, consecutive enrollment, 10-year follow-up study of patients who are treated with the ascension® hra. its purpose is to measure and document the outcomes associated with implanting the ascension hra prosthesis. patients will be periodically assessed to collect data related to safety and effectiveness endpoints at the following intervals: preoperative, surgery/immediate post-op, 3 months, 6 months, 1 year, 2 year, 5 year, and 10 years.

at each assessment interval, information on complications and adverse events will be collected. in addition, shoulder joint range of motion will be collected, and implants will be evaluated radiographically to determine joint position and assess implant with regards to radiolucencies, subsidence and subluxation (migration). patient satisfaction with regard to the effect of the implant on shoulder function, joint pain, and overall satisfaction will be assessed using a visual analog scale (vas). furthermore, if there are any implant revisions during the 10-year follow-up for any of the patients enrolled in the study, the implant and/or surrounding tissue will be harvested if possible and submitted for histopathological examination.

Eligibility criteria:
inclusion criteria: * the following patient will be included in the study - patient who: * is treated with the ascension hra; * is disabled by either non-inflammatory or inflammatory arthritis (i.e. rheumatoid arthritis, osteoarthritis and avascular necrosis; * has mild or moderate humeral head deformity and /or limited motion; * has post-traumatic arthritis; * has an intact or reparable rotator cuff; * has the means and ability to return for all required study visits * is willing to participate in the study; * has signed an informed consent form; * is at least 18 years of age and skeletally mature at the time of surgery; * is less than 75 years of age at the time of surgery exclusion criteria: the following patients will be excluded from the study - patients who: * infection, sepsis, and osteomyelitis; * osteoporosis; * metabolic disorders which may impair bone formation; * osteomalacia; * rapid joint destruction, marked bone loss or bone resorption apparent on x-ray; * revision procedures where other devices or treatments have failed * refuses to be in the study; or does not have the means and ability to return for all required study visits; * currently participating in another clinical study.

Keywords: humeral resurfacing humeral resurfacing arthroplasty
tivanisiran for dry eye in subjects with sjögren's syndrome

Conditions: Dry Eye Disease; Sjögren Syndrome

Summary: this study will examine the efficacy and safety of tivanisiran sodium eye drops versus vehicle after a 2-week run-in phase when dosed once daily for 3 months in subjects with signs and symptoms of dry eye disease (ded) due to sjögren's syndrome.


Eligibility criteria:
inclusion criteria: * subject is a male or a female aged ≥ 18 years * have given their written consent to participate in the study * use of artificial tears (at), autologous serum or specific dry eye medications during the last 6 months prior to the selection * willing to not use at or autologous serum for the study duration * vas scale for dry eye symptom score ≥ 40 * total cfs ≥ 5 * schirmer's test with anesthesia \< 10 mm/5min * patients with sjögren syndrome exclusion criteria: * any concomitant treatment or prior ocular procedure or surgery, or alteration of the dose of systemic medications at the time of entry into the study * use of contact lenses during the study * significant eye diseases according to investigator's opinion

Keywords: oligonucleotide sirna keratoconjunctivitis sicca syl1001
personalizing enzalutamide therapy by understanding the relation between tumor mrnas, mirnas and treatment response

Conditions: Metastatic Castration Resistant Prostate Cancer

Summary: the primary aim is to show whether a reduction in tumor related mrnas and a panel of selected mirnas can be used to personalize enzalutamide therapy. furthermore the aim is to explore the relation between drug exposure and the decrease in the selected biomarkers and treatment response.


Eligibility criteria:
inclusion criteria: * male patients with chemotherapy naive metastatic castration resistant prostate cancer\* * age at least 18 years * patients from who it is possible to collect blood samples * patient who are able and willing to give written informed consent prior to screening and enrollment * life expectancy of \> 6 months * measurable disease \*definition of crpc according to eau guidelines 2014 exclusion criteria: * none the study objective is to explore the effect of enzalutamide on biomarker exposure in a group of patients treated with enzalutamide in agreement with the drug label. therefore no strict exclusion criteria will be used in this study
a protein supplementation and exercise strategy to promote muscle protein anabolism in frail elderly people

Conditions: Sarcopenia

Summary: the present study is designed to investigate whether timed protein supplementation will increase skeletal muscle mass in the frail elderly population.


Eligibility criteria:
inclusion criteria: * frail elderly individuals * able to understand and perform the study procedures exclusion criteria: * type i or type ii diabetes (fasted blood glucose level ≥7,0 mmol) * no recent history (within 2 years) of participating in any regular resistance exercise training program (general questionnaire) * use of anti-coagulation medication (except of acetyl salicyl acid) * presence of coronary heart disease (ecg) * renal insufficiency (egfr \<60 ml/min/1.73 m2) * allergic or sensitive for milk proteins

Keywords: sarcopenia frail elderly protein drink resistance exercise skeletal muscle mass muscle mass in elderly
the immunological effects and metabolic tolerance of lipid infusion in patients with cirrhosis.

Conditions: Alcoholic Liver Disease

Summary: the study will be an experimental pre-post trial in which patients with ethanol related liver disease (both severe alcoholic hepatitis and decompensated ) admitted in our institute from jun 2013-dec 2014 will be enrolled in the study. those on ryle's tube feeding would receive polymeric blenderized kitchen based liquid diet while those tolerating orally would receive soft/ solid diet as tolerated as per requirement. all the patients would receive same amount of calories i.e., 30-35 kcal/kg ideal body weight/ day and 1-1.2 gm/kg protein. 35-40% of non protein calorie would be provided as fats and rest of the calories will be provided as carbohydrates. all patients will be transfused 250ml of 20% intra lipid per day for 3 consecutive days, over and above the feed provided to them to be taken enterally (orally or through ryle's tube). patients will undergo tests prior to infusion and 72 hours after infusion.


Eligibility criteria:
'inclusion criteria: * subjects aged ≥ 18 years. * patients with alcohol related liver disease (severe alcoholic hepatitis and decompensated cirrhosis) * patients tolerating enteral nutrition. exclusion criteria: * active ongoing gastrointestinal bleed. * unresolved sepsis * allergy to soya oil, eggs, peanuts or other ingredients of intralipid. * co-morbidities like diabetes mellitus, hyperlipidemia, coronary artery disease (cad) and hypothyroidism. * renal failure (s.creatinine \> 1.5mg %) * pregnancy * patients on high inotropic support (requiring more than 1 inotropic support) * refusal to participate in the study
effects of omegas 3 and 6 on alcohol dependence

Conditions: Alcohol Dependence

Summary: context: the treatment of alcoholism is a challenge for psychiatrists and patients. some studies have shown that alcohol alters the environment of the membranes, mainly by modifying their permeability through the lipid fraction. these lipids are known as essential fatty acids (efa) because they are obtained only through the diet, as the human body is unable to synthesize them. linolenic acid (la), or omega 6, and alpha-linolenic acid (ala), or omega 3, are polyunsaturated fatty acids (pufas). finally, ethanol changes the absorption and metabolism of pufas, and it's supplementation may be helpful for alcohol dependence recovery. objective: to assess the effectiveness of pufas supplementation in the treatment of alcohol dependent patients.


Eligibility criteria:
inclusion criteria: * severe alcohol dependence * no history of allergic processes, hepatic, cardiovascular, renal, pulmonary, endocrine or neurological pathologies, as well as no history of psychiatric disorders, dependences other than alcohol and/or tobacco, and blood test results outside the reference range exclusion criteria: * history of allergic processes, hepatic, cardiovascular, renal, pulmonary, endocrine or neurological pathologies * dependences other than alcohol and/or tobacco * psychiatric disorders * test laboratories results outside the reference range

Keywords: pufas alcoholism treatment effectiveness
study to evaluate the efficacy of alks 3831 on body weight in young adults who have been recently diagnosed with schizophrenia, schizophreniform, or bipolar i disorder

Conditions: Schizophrenia; Schizophreniform Disorders; Bipolar I Disorder

Summary: this study will evaluate the effect of alks 3831 compared to olanzapine on body weight in young adults with schizophrenia, schizophreniform, or bipolar i disorder who are early in their illness

in the us adolescent subjects starting at age 16 will be enrolled. in the eu, subjects age 18 and older will be enrolled.

Eligibility criteria:
inclusion criteria: * has less than 24 weeks previous treatment with antipsychotics (cumulative; lifetime) * subject treated with aripiprazole can receive an additional 1 year of treatment at ≤5 mg/day, and this treatment will not be considered as part of the 24 weeks of previous treatment with antipsychotics * has less than 4 years elapse since the initial onset of active-phase of symptoms * has a body mass index (bmi) of \<30 kg/m\^2 * agrees to use an acceptable method of contraception for the duration of the study and for 30 days after the last dose of study drug * subject meets the criteria for a primary diagnosis of schizophrenia, schizophreniform disorder, or bipolar i disorder * for bipolar i disorder, must have been experiencing an episode of acute mania within ≤14 days prior to visit 1 * suitable for outpatient treatment * additional criteria may apply exclusion criteria: * poses a current suicide risk * has a history of poor or inadequate response to treatment with olanzapine * has previously been treated with long-acting injectable antipsychotic medication within the 2 months prior to screening, or has \> 6 months cumulative life use, or has received treatment with electroconvulsive therapy in their lifetime * has initiated treatment with mood stabilizers (eg lithium, valproate, etc) \>2 months prior to visit 1 * has a positive drug screen for opioids, phencyclidine (pcp), amphetamine/methamphetamine, or cocaine * has taken opioid agonists (eg, codeine, oxycodone, tramadol, morphine) within the 14 days prior to visit 1, or has taken opioid antagonists, including naltrexone and naloxone, within 60 days prior to visit 1 * taking any weight loss agents or hypoglycemic agents * has a clinically significant or unstable medical illness, condition, or disorder that would be anticipated to potentially compromise subject safety or adversely affect the evaluation of efficacy * has joined a weight management program or had significant changes in diet or exercise regimen within the past 6 weeks * has started a smoking cessation program within the past 6 months * has a history of diabetes * currently pregnant or breastfeeding or is planning to become pregnant during the study or within 30 days of the last study drug administration * additional criteria may apply

Keywords: alkermes alks 3831 olanzapine samidorphan schizophrenia schizophreniform bipolar i
high flow oxygen therapy effect on healthy subjects

Conditions: Healthy Volunteers; Diaphragm; Respiratory Rate

Summary: the use of high-flow nasal cannula (hfnc) has increased. diaphragmatic ultrasonography is a tool that, as a noninvasive complement to esophageal pressure (pes) measurement, allows the evaluation of diaphragm function and reflects, through the diaphragm thickening fraction (dtf), the magnitude of diaphragmatic fiber recruitment. the objective of this study was to evaluate the impact of hfnc therapy on the dtf in healthy subjects. second, this study aimed to assess the behavior of the respiratory rate (rr) and the work of breathing in these subjects.


Eligibility criteria:
inclusion criteria: * healthy subjects over 18 years old exclusion criteria: * contraindication for esophageal balloon placement * diagnosis of lung disease * smokers

Keywords: high flow nasal canula high flow nasal canula therapy diaphragm thickening fraction work of breathing respiratory rate
respiratory monitoring during right heart

Conditions: Pulmonary Hypertension; Heart Failure

Summary: respiratory monitoring during right heart catheterization to differentiate between various types of pulmonary hypertension; the effects of the cardiovascular system on the lung mechanical properties.

differentiation between different kinds of pulmonary hypertension (phtn) requires right heart catheterization. monitoring heart failure patients is challenging in many. the study will enroll patients undergoing right heart catheterization (rhc) for the evaluation of heart failure and phtn, based on the regular clinical practice. the regular indices as the right ventricle pressure (rvp), pulmonary artery pressure (pap), pulmonary artery wedge pressure (pawp), and cardiac output will be measured with the swan ganz catheter and recorded. noninvasive measurement of the respiratory flow will be acquired by a medical approved flow-meter that is mounted on a simple plastic breathing mask. non-invasive system that includes three accelerometers that are attached to the chest and epigastrium of the patient will be used to measure respiratory chest wall dynamics. through evaluating the correlation between the invasive and non-invasive measurements the study intends to prove the ability of the non-invasive system to provide the required information.

Eligibility criteria:
inclusion criteria: * patients undergoing right heart catheterization exclusion criteria: * inability or unwillingness to follow or to sign the study protocol.

Keywords: heart failure pulmonary hypertension right heart catheterization
intra hospital mortality risk factors in patients admitted to cardiac intensive care units in 2017 in france

Conditions: Heart Disease; Acute Coronary Syndrome; Acute Cardiac Failure; Heart Rhythm Disorders; Valve Pathologies

Summary: retrospective, observational cohort study. objectives: to identify intra hospital mortality risk factors in patients admitted admitted to cardiac intensive care units (cicu). the clinical main endpoint will be the observed percentage of deaths that occured during the year 2017 in french cicu. to identify the length of stay key determiners of patients admitted in french cicu. the study will use data from one of the french nationwide healthcare systems database (snds) : the national hospital discharge database (pmsi) to be precise.


Eligibility criteria:
inclusion criteria: * being admitted at least one time in a french cicu in 2017 * being covered by the mandatory french national health insurance plan in 2017 without discontinuity exclusion criteria: * being older than 18 years of age

Keywords: cardiac intensive care unit organization prognostic score
a pilot first in man study of excel-ⅱto treat the patients with de novo coronary artery lesions

Conditions: Ischemia; Coronary Artery Disease

Summary: one of the purpose of this study is to assess the preliminary safety and feasibility,and to provide related information and evidence for the design of the further pivotal randomized control trial.the other purpose is to assess the performace of the stent delivery system.

1. single-center, prospective, pilot study 2. de novo,coronary artery, single vessel and single lesion 3. sample size = 45 4. follow- up clinical or phone at 1-month,9-month and annually 2 to 5 years 5. randomization 2:1 angio and oct scheduled follow-up in the hospital 6. follow-up angio and oct randomized 30 patients for 4-month and 15 patiens for 12-month

Eligibility criteria:
inclusion criteria: 1. 18yrs≤age≤75yrs . 2. de novo lesion at native coronary artery. 3. single target vessel and single target lesion. 4. lesion length ≤32mm. 5. rvd 2.5mm～4.0mm. 6. ds%≥70% by visual estimation. 7. target lesion could be covered by only one stent. 8. subjects are willing to follow the specified requirements follow-up. 9. a process by which a subject voluntarily confirms his or her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the subject's decision to participate. informed consent is documented by means of a written, signed and dated informed consent form. exclusion criteria: 1. ami within one week. 2. cto(timi0),lm lesion,ostial lesion,graft vessel lesion,bifurcation (side branch rvd≥2.5mm),isr,mutivessel disease need to be treated. 3. severe calcified lesion unable to predilate. 4. extremely tortuous proximal to the lesion that is inadequate to stent delivery. 5. nyha≥ⅲ or lvef≤40%. 6. prior stenting within 1 year. 7. pregnancy or lactation, and plan in postoperative pregnancy or lactation. 8. subjects had bleeding tendency or blood coagulation dysfunction or pci contraindications, or anticoagulant therapy taboo or can't continue dapt healers at least 1 year. 9. there are other diseases (such as cancer,malignant tumor ,congestive heart failure,organ transplantation or candidate) or abuse history (alcohol cocaine heroin, etc.), scheme compliance is poor, interference related data explanation or the limited life (\< 1 year). 10. to aspirin heparin clopidogrel cobalt chromium alloy rapamycin pla polymer contrast agent of one of allergy. 11. serious liver and kidney function is not complete person. 12. the investigators think that do not fit to enroll the study.

Keywords: mace tvr mi tlf death
cumulative and booster effects of multisession prefrontal tdcs in asd adolescents

Conditions: Transcranial Direct Current Stimulation; Autistic Spectrum Disorder; Electroencephalography

Summary: autism spectrum disorder (asd) is a neurodevelopmental disorder characterized by disturbances in communication, poor social skills, and aberrant behavior. to date, asd has no known cure, and the disorder remains a highly disabling condition. recently, transcranial direct-current stimulation (tdcs), a non-invasive brain stimulation technique, has shown great promise as a potentially effective and cost-effective tool for reducing the core symptoms in patients with autism, such as anxiety, aggression, impulsivity, and inattention. although the preliminary findings in patients with asd are encouraging, it remains to be determined whether this experimental data can translate into benefits in real life. further studies are needed to determine the factors that can lengthen the therapeutic effects or cognitive benefits of tdcs, and to determine possible risk factors associated with relapse in patients with asd. booster sessions of tdcs is an important component of treatment planning and prognosis and may promote better outcomes to control for resurgence of symptoms. this study has three aims. first, the investigators aim to evaluate the therapeutic effects of tdcs on improving cognitive function in patients with asd. second, the investigators aim to better understand the neural mechanisms underlying the neuro-enhancing effects of tdcs in patients with asd. third, the investigators aim to assess the effectiveness of booster treatment cycles of tdcs for enhancing cognitive and social functions in individuals with asd.


Eligibility criteria:
inclusion criteria: * individuals who are confirmed by a clinical psychologist based on the diagnostic and statistical manual of mental disorders-5th ed (dsm-v) criteria of autism spectrum disorder and structured interview with their parents or primary caregivers on their developmental history using the autism diagnostic interview-revised (adi-r). exclusion criteria: * individuals without a confirmed diagnosis from the clinical psychologist, with a history of other neurological and psychiatric disorders and head trauma, or on psychiatric medication will be excluded from the study.
does deficiency in vitamin d induced hypercoagulation or thrombin generation

Conditions: Cardiovascular Disease

Summary: working hypothesis and aims: the aim of our study is to investigate whether vitamin d deficiency could cause increased thrombin generation and a hypercoagulable state healthy volunteers. methods: in total 400 healthy volunteers are planned for inclusion in this trial. after signing an informed consent two blood samples will be obtained from each participant. expected results: invastigator expect to find that volunteers with vitamin d deficiency will have thrombin generation curve compatible with hypercoagulable state and returning to normal after treatment with vitamin d


Eligibility criteria:
inclusion criteria: age \>18 healthy naive to drug treatment - exclusion criteria: no exc criteria -
neural correlates of cognition and mood

Conditions: Epilepsy, Complex Partial

Summary: the overall objective of this study is to determine the neural correlates of cognition and mood. this study represents the first preliminary study to begin investigating cognitive and emotional states in patients who have undergone implantation of invasive electrodes for the purpose of seizure localization. in the post-implantation paradigm where patients remain under close supervision with intracranial instrumentation for recording, this study aims to create the platform and preliminary data to inform a larger study for calibrated examination of neural correlates of cognition and mood. as such, this study has the following specific aims: aim 1: establish a portable platform for the assessment of cognitive, behavioral, and emotional tasks with time synchronization to ecog/seeg recording platform aim 2: quantify the variance in clinical assessments of mood and cognitive function in patients undergoing phase ii epilepsy monitoring aim 3: assess the relationship between validated surveys/tasks and electrophysiology

study interventions are limited entirely to validated surveys completed on a computer or tablet pc, as outlined above. patients may elect to have electrodes to be implanted that are not used in standard-of-care at this institution, but are fda-approved for the same indications. patients who consent and complete enrollment will be asked to complete cognitive and behavioral tasks on a portable computer or tablet pc while the invasive electrodes remain implanted. tasks typically require the patient to think or act and then respond by interacting minimally with the portable computer. the primary outcome for this study includes percentage of completed cognitive or behavioral tasks as a measure of the feasibility of the administration of these tasks. as this is a feasibility study, we are interested in the practical aspects of data acquisition. secondary outcomes include the cognitive and behavioral tasks themselves and their relationship with electrophysiology.

Eligibility criteria:
inclusion criteria: * patient is able to consent for themselves and the patient has or is scheduled for surgically implanted electrodes for the purposes of phase ii epilepsy surgical evaluation. exclusion criteria: * none