Kornimate/medical-research-clean huggingface dataset:
clinical evaluation of the fluidvision accommodation intraocular lens (aiol)

Conditions: Cataract

Summary: the objective of this study is to evaluate the safety and effectiveness of an investigational iol in providing a range of vision as compared to a commercially available trifocal iol in subjects undergoing cataract extraction and iol implantation.

upon obtaining written informed consent and confirmation of subject eligibility via preoperative assessments, subjects were randomized in a 1:1 ratio to receive either the investigational iol or the commercially available trifocal iol in both eyes. the second eye for each subject was implanted after completion of the 1-week follow up for the first implanted eye. the expected total duration of participation for each subject was up to 14 months.

Eligibility criteria:
key inclusion criteria: * require cataract extraction by phacoemulsification; * corrected distance visual acuity (cdva) worse than 20/40 snellen, or presence of visually significant lens opacity; * preoperative or predicted postoperative astigmatism of ≤ 1.0 diopter. key exclusion criteria: * use of current medications that may affect accommodation or confound study results; * systemic disease that may increase the operative risk or confound results; * ocular conditions or degenerative disorders that may predispose the subject to future complications; * monocular subjects or significant permanent visual function loss in 1 eye; * previous ocular surgery in either eye that may confound the results or increase the risk to the subject.

Keywords: intraocular lens eye surgery
vitamin d supplementation to correct the vitamin d deficiency for breast cancer

Conditions: Breast Cancer

Summary: an open clinical trial not randomized, multicentric. this study search to evaluate vitamin d supplementation efficacy at high dose (uvedose, colecalciferol, oral solution at 100 000 ui) of vitamin d on day 1 of each cycles for breast cancer treated adjuvant chemotherapy. a calcium supplementation will be prescribed in parallel. an initial dosage of 25oh vitamin d rate will be done and a vitamin-calcic dosage will done on day 1 of every cycles of chemotherapy


Eligibility criteria:
inclusion criteria: * breast adenocarcinoma should receive 6 cycles of adjuvant chemotherapy * women ≥ 18 years old (no age limit) * performance status :0 or 1 * patients must be affiliated to a social security system * signed informed consent obtained before any study specific procedures. * vitamin d deficiency confirmed ( vitamin d result must be \< at 30 ng/ml) exclusion criteria: * metastatic disease * patients with previous or concomitant other (not breast cancer) malignancy within the past 5 years except adequately treated basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix. patients who have had a previous other malignancy must have been disease free for at least five years * calcium or colecalciferol contraindications (vitamin d hypersensitivity - disease or an other condition result in hypercalcaemia or hypercalciuria -calcic lithiasis- high vitamin d level) * presence of the following diseases in the last 3 years : endocrinal disease, a phosphor calcic disorder treated by vitamin d supplementation at 1000 ui/day or more (this patient who have received a dose \< 1000 ui/day, will be included after have to stop vitamin d at least 48 hours ) - osteopenia or osteoporosis confirmed treated * concomittant treatment with an other experimental product * pregnant or breastfeeding women * legal incapacity or physical, psychological or mental status interfering with the patient's ability to sign the informed consent or to terminate the study.
brain and mindfulness

Conditions: Healthy

Summary: the main aim of this project is to explore the neuro-anatomical and -physiological correlates of meditation on attention and emotion-regulation. by investigating this, our scientific goal is to more generally identify the mechanisms and biomarkers of health and mental well-being. therefore, the investigators use non-invasive imaging like magneto-encephalography (meg), electroencephalography (eeg), functional and anatomic magnetic resonance imaging (mri; including diffusion tensor - dti). these brain measures will then be linked to behavioral measurements. experimental methods (i.e., simple computer tasks) will be used to measure attention, conscious perception and regulation of pain and emotion.


Eligibility criteria:
inclusion criteria: * age : 25-70 * being affiliated to a social security system. * motivated to participate in this study. exclusion criteria: * medication acting on the central nervous system * opioids, antidepressive agents. * actual or previous neurological or psychiatric illnesses * chronic pain or any other medical condition which is related to pain or an increased sensitivity to pain. * not having a personal or family history of epilepsy * alcohol or drugs consumption 2 days before or during the study.
renal artery denervation in chronic heart failure study

Conditions: Chronic Systolic Heart Failure

Summary: the reach study, is a prospective, double-blinded, randomised, controlled study of the safety and effectiveness of renal denervation in subjects with chronic systolic heart failure. bilateral denervation will be performed using the symplicity catheter - a percutaneous system that delivers radio frequency (rf) energy through the luminal surface of the renal artery.

interventional study allocation: randomised endpoint classification: safety / efficacy study intervention model: parallel assignment masking: double blind (subject / chf team). the interventional operator, will have no role in care of the patient following randomisation. primary purpose: treatment chronic systolic heart failure device: renal denervation (symplicity catheter system) symplicity catheter system -intervention: device: renal denervation (symplicity catheter system) patients are randomised in the cath lab to receive either renal denervation or sham procedure. experimental arm: renal denervation control arm: no renal denervation (sham procedure) in both arms, aftercare is provided by clinicians who are blinded to the randomised allocation arm. subjects will have been recruited on stable heart failure therapy, and the intention is to maintain this therapy steady during followup.

Eligibility criteria:
inclusion criteria: * chronic heart failure due to systolic dysfunction * new york heart association class ii or higher * maximal pharmacological therapy including (where clinically indicated and tolerated), b-blocker, ace inhibitors /a2 blocker, aldosterone blockade. * ejection fraction less than 40% exclusion criteria: * estimated gfr\<35ml/hr * unfavourable renal anatomy (renal artery stenosis) * unable to walk on a treadmill for cardiopulmonary exercise test * significant valvular disease (moderate or more aortic regurgitation/stenosis or mitral stenosis; severe mitral/tricuspid regurgitation) * severe lung disease * symptomatic orthostatic dizziness * unable to consent * pregnancy
think fast research study

Conditions: Age-related Cognitive Decline

Summary: to test a 14-hour prolonged nightly fasting (pnf) protocol in a group of older adults (≥ 65 years old) with self-identified age-related cognitive decline (arcd) on the primary outcome of neurocognitive function and performance as measured by objective outcomes. the investigators will use an 8-week single group pre-post pilot study design to measure outcomes related to neurocognitive function and performance and cardiometabolic risk factors (i.e., sleep disturbances, body mass index).


Eligibility criteria:
inclusion criteria: * 65 or older * self-identified age-related cognitive decline (arcd) * has a text capable phone and access to wifi exclusion criteria: * diagnosed with an eating disorder in the past 20 years * works a night shift * cannot participate in a 14 hour fast * has diabetes
is medicinal cannabis an effective treatment for tourette syndrome in adolescents? a pilot study

Conditions: Tourette Syndrome in Adolescence

Summary: this is a single site, pilot double-blind, randomized, placebo-controlled, cross-over study of 10 participants comparing medicinal cannabis (thc:cbd 10:15 oil) with placebo in reducing tics in adolescents aged 12 - 18 years with severe tourette syndrome (ts). the primary objective of this pilot study is to evaluate all elements of the study design (recruitment strategy, study duration, study procedures, study medication tolerance and outcome measures) to assess if they are acceptable and feasible for the conduct of a full-scale randomized controlled trial of thc:cbd 10:15 oil to reduce tic severity in adolescents with ts. the secondary objective of this study is to collect preliminary data on the safety of oral thc:cbd 10:15 oil in adolescents aged 12 to 18 years with ts. as an exploratory aim data from clinician- and parent-rated measures will be compared across the phases to explore for a signal of efficacy on primary (tic reduction) and secondary (premonitory urges, obsessive compulsive behaviors, attention deficit hyperactivity disorder \[adhd\] symptoms) outcome measures.


Eligibility criteria:
inclusion criteria: * males and females aged 12 - 18 years of age; * dsm-5 (diagnostic and statistical manual of mental disorders, fifth edition) diagnosis of ts as assessed by the study clinician; * ts severity defined as a score of 20 or higher on the total tic severity section of the yale global tic severity scale; * no changes in either medication or other interventions in the 4 weeks prior to randomization, and intention to remain on same dose for the duration of the study; * participant and family have the ability to comply with the protocol requirements, in the opinion of the investigator; * agrees not to drive for the duration of the study. exclusion criteria: * non-english speaking parents; * participant history of psychosis, schizophrenia, bipolar disorder, or major depressive disorder, or a family history of psychosis; * taking anti-epileptic medications which interact with medicinal cannabis: clobazam, mtor (mammalian target of rapamycin) inhibitors (e.g sirolimus, tacrolimus), anti-cancer agents, citalopram \>20mg/day, escitalopram \>10mg/day; * abnormal liver function tests defined as alt (alanine transaminase) \> twice uln (upper limit of normal); * current use of illicit drugs or medicinal cannabis, or use in the 4 weeks prior to screening; * pregnant or intending to become pregnant during the study, or breastfeeding; * history of clinically significant suicidal thoughts in the prior 12 months.
pilot feasibility of app-supported vestibular rehabilitation

Conditions: Vestibular Disorder

Summary: the primary goal of the study is to examine the feasibility of accompanying vestibular practice supported by a phone app for vestibular rehabilitation. feasibility will be established using the following parameters: (1) the user satisfaction evaluation questionnaire (useq) (2) a custom-made questionnaire to collect feedback from participants, and (3) compliance measurements derived from app usage. the secondary goal of the study is to examine the effect of practice supported by the app on balance and anxiety indices. these will be measured using the following parameters: (1) instrumented timed up and go test (itug), (2) dizziness handicap inventory (dhi), (3) state-trait anxiety inventory (stai). the third goal is to assess the correlation between balance function (itug) and anxiety (stai). a randomized crossover pilot study will be conducted with 24 participants. during the study, each group will undergo two and a half weeks of conventional vestibular rehabilitation and two and a half weeks of app-supported vestibular rehabilitation. measurement sessions will be conducted at three-time points: upon enrollment in the study (t0), after two and a half weeks (t1), and at the end of the study (t2).


Eligibility criteria:
inclusion criteria: participants that will meet the following inclusion criteria were recruited to the study: 1. between the ages of 18-75; 2. diagnosis of vestibular dysfunction; 3. fluent in hebrew; 4. own an android smart-phone exclusion criteria: exclusion criteria for the study group will be as follows: 1. a medical condition that prevents participant from performing home vestibular rehabilitation practice - such as orthopedic, neurological, cardiac, visual impairment; 2. individuals with dizziness who already have been given a home vestibular rehabilitation exercise program; 3. diagnosis of central vestibular disorder due to brain structural damage.
feasibility study of microkine dx system in critically-ill pediatric patients.

Conditions: Multiple Organ Failure

Summary: this study will enroll approximately 25 pediatric patients to assess the performance and real-world feasibility of multi-biomarker based prognostic and predictive algorithms to aid in the clinical management of pediatric critically-ill patients.

this study will enroll approximately 25 pediatric patients to assess the predictive performance of multi-biomarker based prognostic and predictive algorithms to aid in the clinical management of pediatric critically-ill patients. all enrolled patients will undergo a series of blood collection procedures during their admission to the pediatric intensive care unit. the levels of inflammatory cytokines, chemokines, and effectors will be assessed and used in multi-biomarker based prognostic and predictive algorithms to determine patients at risk of in-hospital mortality.

Eligibility criteria:
key inclusion criteria: 1. age 38 weeks gestation to 21 years of age 2. admitted to the picu within the prior 24 hours 3. indwelling catheters for obtaining blood 4. meet ≥2 age-adapted sirs criteria key exclusion criteria: 1. anticipated pediatric intensive care unit admission \<24 hours 2. primary immunodeficiency 3. limited resuscitation, no escalation of treatment, do not resuscitate, or other limitations to care note: other protocol defined inclusion/exclusion criteria may apply.
outcome of iv acetaminophen use in laparoscopic cholecystectomies in patients at risk of osa

Conditions: Cholecystitis; Cholelithiasis; Obstructive Sleep Apnea

Summary: the objective of this study is to determine if iv acetaminophen administered intraoperatively can decrease the dose of narcotics required for adequate pain control and shorten recovery time in the pacu specifically in obese patients at risk for obstructive sleep apnea.

obese adult patients at risk for having osa will be randomized into two groups: those receiving intraoperative iv acetaminophen and those not receiving the drug. the patients will be blinded to the administration of acetaminophen. for the group randomized to receive the study drug, anesthesia providers will be instructed to administer 1000mg of iv acetaminophen intraoperatively immediately after induction. they may utilize narcotics and other pain medication perioperatively at their discretion according to their perceived patients' needs. post-operatively in the recovery unit, all patients will be monitored according to current standards with appropriate oxygen supplementation as needed, and they may receive narcotics or other adjuncts as ordered by the anesthesia provider. recovery nurses will record vital signs, aldrete score, pain score, and drugs administered per standard protocol. the recovery nurses will be blinded to the study group, and no patients regardless of control vs. study group will be allowed to receive acetaminophen in the pacu or for six hours from surgery end time due to fda approved dosing of iv acetaminophen no more frequently than every six hours. the patients' recovery data will then be de-identified and reviewed, and each of the groups' recovery time, narcotic use, pain score, and any complications will be examined and compared.

Eligibility criteria:
inclusion criteria: * obesity (bmi greater than or equal to 30) * symptoms of obstructive sleep apnea as determined by an osa questionnaire patients will complete preoperatively * prior diagnosis of obstructive sleep apnea * undergoing laparoscopic cholecystectomy * 18 years old or greater exclusion criteria: * negative osa questionnaire or recent negative workup * open cholecystectomy or conversion to open procedure intraoperatively * allergy to acetaminophen * severe hepatic dysfunction * pediatric patients * patients unable to consent for themselves

Keywords: cholecystitis cholelithiasis obstructive sleep apnea acetaminophen
cerenovus neurothrombectomy devices registry

Conditions: Cerebral Stroke

Summary: a post-market registry evaluating the embotrap® revascularization device, cerenovus large bore catheter/ embovac™ aspiration catheter, and cereglide 71 intermediate catheter in acute ischemic stroke patients with confirmed intracranial vessel occlusion.

the objective of this study are to separately assess the effectiveness of the cerenovus neurothrombectomy devices (embotrap® revascularization device, large bore catheter/embovac aspiration catheter, and cereglide 71 intermediate catheter) in a real-world setting, as well as to explore correlations between patient comorbidities, clot characteristics, revascularization rates, and clinical outcomes.

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 2. the participant or the participant's legally authorized representative has signed and dated an informed consent form. in the event that local regulations allow for alternative approaches of consent, these must be fulfilled as approved by the sponsor and site's ethics committee/regulatory authority (if applicable) 3. participants experiencing acute ischemic stroke with angiographic confirmation of intracranial vessel occlusion 4. a clinical decision has been made to use a cerenovus neurothrombectomy device (embotrap® revascularization device, large bore catheter/ embovac aspiration catheter, or cereglide 71 intermediate catheter) independently and prior to enrollment in the research study 5. a cerenovus neurothrombectomy device is the first attempted primary device/technique for mechanical thrombectomy for the intracranial occlusion in the participant. the following primary devices/techniques are eligible for this study: a) embotrap® revascularization device alone b) embotrap® revascularization device + co-aspiration with the large bore catheter/embovac aspiration catheter or cereglide 71 intermediate catheter c) embotrap® revascularization device + co-aspiration with any other aspiration catheter d) large bore catheter/embovac aspiration catheter alone (that is, direct aspiration with no stent retriever in the first attempted technique) e) cereglide 71 intermediate catheter alone (that is, direct aspiration with no stent retriever in the first attempted technique) exclusion criteria: 1. currently participating in an investigational (drug, device, etc) clinical trial that may confound study endpoints. patients in observational, natural history, and/or epidemiological studies not involving intervention are eligible 2. confirmation of positive pregnancy test according to site specific standard of care (example, test, verbal communication) 3. use of multiple stent retrievers on the first pass

Keywords: mechanical thrombectomy embotrap embovac cereglide 71
effects of amlodipine/benazepril in the hypertensive african-american population with type 2 diabetes mellitus

Conditions: Hypertension

Summary: this study evaluated the efficacy and safety of amlodipine/benazepril compared with that of enalapril in the treatment of hypertension in african-american patients with type 2 diabetes.


Eligibility criteria:
inclusion criteria: * african-american * males and females * current diagnosis of type 2 diabetes documented by medical history; * mean sitting diastolic blood pressure of ≥ 90 and ≤ 110 mm hg; * hba1c ≤ 9.5% exclusion criteria: * having unilateral or bilateral renal artery stenosis; * having clinically significant cardiac dysrhythmias; * having a significant history of coronary artery disease within the past 6 months; * having a history or diagnosis of congestive heart failure (chf); * having any clinically relevant cardiac valvular disease

Keywords: hypertension, diabetes, african-american, amlodipine/benazepril
predictive value of diffusion-weighted mri performed in early post-treatment in the occurrence of tumor recurrence or progression in head and neck squamous cell carcinoma treated with chemoradiotherapy: a pilot study

Conditions: Head and Neck Squamous Cell Carcinoma

Summary: head and neck squamous cell carcinoma are frequent. the chemoradiotherapy protocols are part of the reference treatment of locally advanced stage tumors. diffusion-weighted mri (dw-mri) is a non radiating imaging, not requiring injection of gadolinium, giving informations on tumor activity, based on the brownian motion of water molecules. the differences in motion are expressed by the apparent diffusion coefficient (adc). the adc variations reflect changes in water molecules motion and redistribution between the intra- and extracellular compartments. several studies have shown that malignant lesions have an adc coefficient lowered as compared to benign lesions.

study the diagnostic performance of diffusion mri performed in early post treatment, notably changes in the adc factor, in the onset of tumor recurrence or progression in patients showing no residual tumor at the end a treatment by chemoradiotherapy for squamous cell carcinoma of head and neck seat. compare the characteristics of diffusion mri, such as adc coefficient, between patients with residual tumor and patients with no residual tumor after chemoradiotherapy for squamous cell carcinoma of head and neck location.

Eligibility criteria:
inclusion criteria: * patients with head and neck squamous cell carcinoma * patients with indication of a treatment by chemoradiotherapy (without surgical indication) * patient consenting to participate to the study * patient enrolled in the national healthcare insurance program * patient older than 18 years exclusion criteria: * patients with contraindications for mri