Kornimate/medical-research-clean huggingface dataset:
performance and safety assessment of t2769 in contact lens wearers with dry eye symptoms.

Conditions: Dry Eye

Summary: this is a confirmatory clinical investigation. the objective is to collect new additional clinical data demonstrating the safety and performance of the device in the contact-lens wearing population with dry eyes. the hypotheses are that t2769 improves dry eye symptomatology (e.g. decrease in cldeq-8 score, in osdi score, ocular discomfort assessed by vas) and signs (e.g. increase in schirmer and tbut, decrease in oxford score) at d36, in comparison to baseline. the primary objective of this investigation is to assess the performance of t2769 in contact lens wearers with dry eye symptoms in terms of change from baseline (day 1) to day 36 (final visit) in contact lens dry eye questionnaire-8 (cldeq-8) total score.


Eligibility criteria:
main inclusion criteria: * informed consent signed and dated * patient aged ≥ 18 years old * well fitted contact lenses (cl) according to the investigator judgement * daily wearer of any type of cl for a minimum of 5 days/week for 6 hours/day over at least the last month and is willing to continue to do so during the study * patient with an ocular surface disease index (osdi) score ≥ 18 * cldeq-8 score ≥ 12 main exclusion criteria: * far best-corrected visual acuity (bcva) ≥+0.7 logmar (e.g., ≤0.2 in decimal value or ≤20/100 snellen equivalent or ≤50 etdrs letters). * severe blepharitis * severe meibomian gland dysfunction * palpebral or nasolacrimal disorders * dry eye associated with at least one of the following diseases/symptoms: ocular rosacea, pterygium, eyelid malposition, corneal dystrophy, ocular neoplasia, filamentous keratitis, corneal neovascularisation, orbital radiotherapy, cataract, retinal disease.
evaluation of safety and performance of the atalante system with patients with lower limb paralysis

Conditions: Spinal Cord Injuries; Paraplegia; Paralysis, Lower Limbs; Lower Extremity; Robotics

Summary: the study is a prospective, open, bicentric and observational study. it is conducted to assess the safety and performance of the atalante exoskeleton system with patients with lower limb paralysis. the principal objective is to assess the performance of the atalante system in performing ambulatory functions with motor complete sci patients characterized by the success rate in performing a 10mwt at the last session of training with the atalante system.


Eligibility criteria:
inclusion criteria: * motor complete traumatic spinal cord injury (ais a and b) since at least 4 months * spinal injury level between ais t5 and ais t12 * able to verticalize on a daily basis * height: between approximately 1.60 and 1.90 m. more specifically, atalante is able to accommodate the following limb lengths: * thigh: 380-460 mm * distance between the ground and the joint space of the knee (to be measured while wearing the shoes they intend to wear with atalante): * 457-607 mm for patient with an ankle dorsiflexion ≥ 16° * 457-577 mm for patient with an ankle dorsiflexion between 13° et 16° * 457-567 mm for patient with an ankle dorsiflexion between 10° et 13° * 457-557 mm for patient with an ankle dorsiflexion between 0° et 10° o hip width less of equal to 460 mm when seated * maximum weight: 90 kg * patient having given his written consent exclusion criteria: * patients whose joint centers cannot be aligned atalante's * ranges of motion below: * hip: 115° flexion, 15° extension, 17° abduction, 10° adduction, 10° medial rotation, 20° lateral rotation * knee: 5° extension, 110° flexion * ankle: 0° dorsiflexion, 9° plantar flexion, 18° inversion and eversion * severe spasticity (greater than 3 on the modified ashworth scale) of the adductor muscles, hamstrings, quadriceps and triceps surae * pregnant or lactating woman * unbalanced psychiatric or cognitive status which may interfere with an appropriate use of the device * other neurological disorder * history of osteoporotic fracture and/or disease or treatment responsible for a secondary osteoporosis * active implantable medical device * evolutive intercurrent disease: pressure sore, infection, venous thrombosis * unstable and unhealed limb and pelvic fracture * unstable spine * severe illness which may interfere with the verticalized posture and tolerance to effort * evolutive osteoma * syringomyelia

Keywords: spinal cord injuries paraplegia paralysis, lower limbs lower extremity robotics physiotherapy rehabilitation powered exoskeleton walking ambulation
examination of implant´s safety in an electronic and magnetic field environment

Conditions: Disorder of Cardiac Pacemaker System; Disorder of Implantable Defibrillator; Cardiac Arrhythmia

Summary: the number of active electrical cardiac implants such as internal cardioverter defibrillators (icds), pacemakers or cardiac contractility modules (ccm) has significantly risen over the last two decades. this has been paralleled by an increase in the number of sources of electromagnetic fields in daily life and occupational circumstances. to date it remains unclear whether patients are at risk of device failure when being subjected to these fields. there are currently no general guidelines available to help clinicians informing their patients about safety levels and behavior around these electromagnetic fields. this study aims to identify the thresholds of safe use of these devices and potential failures under worst-case conditions in 50/60 hz fields (i.e. power line frequency). device implanted patients will be exposed to electric, magnetic and combined fields of different intensity at various device programming (e.g. nominal and maximum sensitivity). the results will show whether patients are safe in public or occupational environments, which medical relevant disturbances can occur and if a correlation exists between disturbances and device type or patients physique.


Eligibility criteria:
inclusion criteria: * men and women between 18 and 80 years * implantation of a pacemaker (sm)-/ icd-assembly at least four weeks ago * signed informed consent exclusion criteria: * enduring addiction of implant * thyroid disease * electrolyte imbalance on the trial day * pregnancy and breastfeeding * acute myocardial infarction (\<30 days) * comorbidity, which complicates an emergency assistance, e.g. morbus bechterew, glaucoma, micturition disturbance
ranolazine loading to prevent pci-induced myocardial injury

Conditions: Coronary Artery Disease

Summary: it has previously been shown that pretreatment with ranolazine 1,000 mg twice daily for 7 days can significantly reduce procedural myocardial injury in elective percutaneous coronary intervention (pci). the investigators tested the hypothesis that twice overnight high-dose ranolazine loading before pci can reduce the peri-procedural myocardial ischemic damage similarly to long-term pre-treatment with standard doses.

background ranolazine is a novel antianginal drug that reduces intracellular sodium and calcium accumulation during ischemia thus limiting ischemic injury. it has previously been shown that pretreatment with ranolazine 1,000 mg twice daily for 7 days can significantly reduce procedural myocardial injury in elective percutaneous coronary intervention. it remains unknown, however, which of these two therapeutic approaches is more effective after pci. purpose the primary objective of this study is to test the hypothesis that twice overnight high-dose ranolazine loading before pci can reduce the peri-procedural myocardial ischemic damage similarly to long-term pre-treatment with standard doses.

Eligibility criteria:
inclusion criteria: * angiographically-proven coronary artery disease * class i indication to elective percutaneous coronary intervention * stable conditions * no recent acute coronary syndromes * normal baseline values of markers of myocardial damage (creatine kinase, creatine kinase-mb, myoglobin, and troponin i) * able to understand and willing to sign the informed consent form exclusion criteria: • women of child bearing potential patients must demonstrate a negative pregnancy test performed within 24 hours before

Keywords: periprocedural myocardial infarction ranolazine
a pilot trial to evaluate the effect of diet and exercise in renal transplant recipients on tacrolimus

Conditions: Renal Transplantion; Kidney Transplantion

Summary: the purpose of this trial is to investigate whether a combined dietary and exercise intervention, added to standard care, reduces the expected frequency of insulin resistance in renal (kidney) transplant recipients on tacrolimus.

this is an open-label (all people know the identity of the intervention), prospective (study following participants forward in time), single-arm, multi-center (conducted in more than 1 center), interventional pilot study of the effects of a combined dietary and exercise intervention on glucose metabolism. the duration of this study will be 6 months and will include following visits: baseline, week 4, week 12, and week 24. dietary compliance will be evaluated with a 3-day food record and during weekly telephone conversations and face-to-face visits with a dietician. exercise compliance will be measured using an exercise log presented to the co-ordinator at the end of each month. primarily, participants with insulin resistance will be assessed by homeostasis model assessment-insulin resistance (homa-ir) of greater than 1 at 6 months. participants' safety and tolerability will be monitored throughout the study.

Eligibility criteria:
inclusion criteria: * participants who has sufficiently recovered from surgery to tolerate an intensive exercise evaluation * participants who have received a living-donor or cadaveric (from dead donor) renal transplant * participants who has been initiated tacrolimus as first-line immunosuppressive agent * participants who has given informed consent forms exclusion criteria: * participants with significant disease or disability that prevents taking part in a diet or exercise regime (e.g. cardiac instability, including unstable angina \[chest pain due to decreased oxygen being supplied to the heart\] and/or other unstable disease, severe cognitive \[mental functioning\] impairment) * participants with significant post-surgical complications that prevent participation in the exercise component of the study (e.g. wound dehiscence \[pathologic process consisting of a partial or complete disruption of the layers of a surgical wound\] or infection) * participants with contraindications to maximal exercise testing or high-intensity progressive resistance training (e.g. proliferative diabetic or hypertensive retinopathy, un-repaired aneurysm, critical aortic stenosis, recurrent symptomatic hernias, new york heart association (nyha) class-iv congestive heart failure) * participants with non-ambulatory (mobility) status * participants who require ongoing systemic immunosuppressive therapy for an indication other than renal transplant and this therapy is higher than that required for their kidney disease

Keywords: tacrolimus prograf pride
the effects of dexmedetomidine on peroperative shivering incidence under spinal anesthesia

Conditions: Perioperative/Postoperative Complications

Summary: the purpose of this study to compare the efficacy of intravenous or intrathecal dexmedetomidine on the incidence of shivering on patients who scheduled spinal anesthesia for elective surgery.

the design of the study includes three study groups done in random order. the groups are as follows: 1) control group received 15 mg levobupivacaine intrathecally and intravenous 0.9% sodium chloride; 2) intravenous group received 15 mg levobupivacaine intrathecally and intravenous dexmedetomidine (1mcg/kg/10min, 0.5mcg/kg/h infusion) ; 3) intrathecal group received 15 mg levobupivacaine + 3 mcg dexmedetomidine intrathecally and intravenous 0.9% sodium chloride. throughout the study period,shivering scores, tympanic temperature were recorded, heart rate were measured continuously using an electrocardiogram; blood pressure was determined oscillometrically at 5 min intervals at the ankle. in case heart rate decreased by more than 30% of the baseline atropin received and blood pressure decreased 30% of the baseline effedrin received. side effects (bradycardia, hypotension, hypothermia, nausea and vomiting etc ) were recorded peroperatively in the operating room and postanesthetic care unit.

Eligibility criteria:
inclusion criteria: * 18-65 y/o patients * american society of anesthesiologists' physical status class i-ii * scheduled for the spinal anesthesia exclusion criteria: * patients who have the body temperature over 37.3 celsius degree * pregnants * known allergies to the study drugs * contraindication to spinal anesthesia

Keywords: shivering dexmedetomidine spinal anesthesia
feasibility of the utilization of buprenorphine in the emergency room to treat clinical opioid withdrawal

Conditions: Drug Overdose; Opioid Withdrawal; Opioid-use Disorder

Summary: the investigators are trying to determine whether they can effectively treat patients suffering from acute opioid withdrawal in the emergency department at virginia commonwealth university health system (vcuhs) and subsequently transfer them to an outpatient addiction clinic within the existing infrastructure. this will be a descriptive investigation of the process to reveal areas of success and opportunities for improvement in order to determine feasibility of the study procedures in preparation for a larger clinical investigation.

currently, patients in the emergency department at vcuhs experiencing opioid withdrawal, after reversal of opioid intoxication by naloxone, do not receive any direct treatment to stop the symptoms. they do receive indirect treatment aimed at each specific symptom, such as an anti-emetic to stop vomiting. the investigators propose directly treating all of the symptoms with the medication suboxone, (buprenorphine/naloxone). buprenorphine is a partial agonist on the mu-receptor, which means it will provide less opioid effect than morphine, but should provide enough to make opioid withdrawal more tolerable. this is very important because stopping the withdrawal symptoms early will prevent the patient from quickly leaving and using opioids again, continuing their addiction cycle. the naloxone is included with buprenorphine as a deterrent to prevent intravenous injection of the drug for abuse. the investigators believe that if the patient is treated with suboxone for withdrawal in the emergency department, and transported to the outpatient addiction treatment center at vcu, called the motivate clinic, the investigators can potentially break that cycle and help the patient work toward recovering. if successful, the investigators hope to improve the quality of life, prevent further overdose and death in those suffering from this deadly addiction. buprenorphine effectively treats the opioid withdrawal state. this has been demonstrated in many studies during the initial induction period with buprenorphine. many of these patients are experiencing opioid withdrawal during this time. the sublingual dose can effectively be increased to resolve symptoms. according to many protocols and guidelines, acute opioid withdrawal is the preferred state of the patient when buprenorphine should be started.

Eligibility criteria:
inclusion criteria: * opioid overdose only, of any formulation or route, with complete reversal of toxicity after naloxone by any route. * rr ≥ 12 * pulse oximetry \> 95% * gcs 15 * clinical opioid withdrawal scale (cows) score ≥ 8 exclusion criteria: * pregnancy * prisoner * incomplete reversal of toxicity related to metrics above * police custody * known allergy to buprenorphine * emergent psychiatric condition including active suicidality that requires admission * emergent medical condition that requires admission
a multi-center randomized double-blind placebo-controlled study to investigate the effect of isoprinosine in immunodepressed patients with uncomplicated generalized lymphadenopathy

Conditions: Lymphatic Disease; HIV Infections

Summary: the objective of this phase iii, randomized, double-blind, placebo-controlled study in patients with immunologic deficiency is to determine the effect of isoprinosine in producing an immuno-restorative response within the study observation period (including the 2-month period following cessation of the 28 days of treatment), measured by one or more of the following immunologic parameters: * increase in natural killer (nk) cell activity. * increase in total t-cells (okt-11). * increases in absolute number and percentages of t-helper cells (okt-4).


Eligibility criteria:
exclusion criteria co-existing condition: patients with the following are excluded: * history of gout, uric acid urolithiasis, uric acid nephrolithiasis, renal dysfunction, and severe gastric ulcer. * lymphoid malignancy. * infectious mononucleosis caused by cytomegalovirus (cmv) or epstein-barr virus (ebv). * heart disease (especially if receiving cardiac glycosides). * hemophilia. patients with the following are excluded: * kaposi's sarcoma or overt opportunistic infections. * active evidence of infectious mononucleosis caused by epstein-barr virus (ebv) or cytomegalovirus (cmv) as determined by heterophile test (ebv) or cell culture (cmv). * a history of gout, uric acid urolithiasis, uric acid nephrolithiasis, renal dysfunction, and severe gastric ulcer. * critical illness. * condition requiring hospitalization. * women of childbearing age are excluded. prior medication: excluded: * steroids, cytotoxic immunosuppressive agents. * antiviral medicine. * excluded within 1 month of study entry: * immunomodulators (including isoprinosine). prior treatment: excluded: * radiotherapy. patients who have unexplained immunodepression and are at risk of developing aids. * patients with prolonged generalized lymphadenopathy for 3 or more months (greater than 1 cm at two or more noncontiguous sites). iv drug abuse.

Keywords: t-lymphocytes immune tolerance inosine pranobex killer cells t-lymphocytes, helper-inducer acquired immunodeficiency syndrome aids-related complex
ketamine in acute brain injury patients.

Conditions: Brain Injuries, Traumatic

Summary: although, in the past years, an increasing use of ketamine in traumatic brain injury (tbi) has been reported as an adjunct to other sedatives, there is no evidence from randomized clinical trial to support this practice. the bike (brain injury and ketamine) study is a double-blind placebo controlled randomized multicenter clinical trial to examine the safety and feasibility of using ketamine as an adjunct to a standard sedative strategy in tbi patients.

in this study the effects of ketamine as an adjunct to an standard sedation regime in adult tbi patients will be investigated on the therapy intensity level and intracranial pressure. all patients will receive propofol for sedation to control icp, to a maximum dose of 4 mg/kg/h. if the icp is not controlled at the maximum dose of propofol, midazolam will be added, to a maximum dose of 0.3 mg/kg/h, as part of the current standard of care in the participating sites. all patients will receive remifentanil, fentanyl or sufentanil infusions for pain relief. the study medication (ketamine or placebo) will be started after randomization. as part of the current standard of care in the participating sites, the decision for decompressive craniectomy and/or barbiturate coma will be taken after multidisciplinary consultation between the treating intensivist and neurosurgeon. the decision to stop or reduce sedation, lies with the treating physician, based on the level of icp control, the absence of clinical or radiological signs of deterioration of the neurologic state. in the case of barbiturate coma, the study drug will be discontinued. during and following decompressive craniectomy, the sedative regime (propofol/midazolam/study drug/ opioids) will be continued. in case of suspected or threatening propofol-related infusion syndrome, propofol will be stopped and switched to midazolam. in case of hypertriglyceridemia \>200 mg/dl, propofol will be reduced and if necessary, midazolam will be associated to allow control of sedation. during surgical procedures related to the traumatic brain injury or not, the study drug will not be discontinued. the use of open label administration of ketamine is not allowed during the course of the trial, i.e until hospital discharge.

Eligibility criteria:
inclusion criteria: * traumatic brain injury patients * age \>= 18 years * admitted to the icu * within 72 hours after admission to the initial hospital: * icp monitoring in place (parenchymal probe, ventricular catheter, or both) * requiring sedation exclusion criteria: * known pregnancy and/or lactation * imminent or actual brain death upon inclusion * allergy or intolerance to the study medication * pre-existing neurocognitive disorders, pre-existing congenital or non-congenital brain dysfunction. * inability to obtain informed consent * inclusion in an interventional randomised controlled trial of which the pi indicates that co-inclusion specifically in the bike study is prohibited. * therapy restriction code upon inclusion. * porphyria * glaucoma
cancer patients treated with immunotherapy in intensive care unit

Conditions: Cancer; Critical Illness; Immunotherapy

Summary: this work aims to describe the characteristics and methods of management of patients suffering from a solid tumor treated with immunotherapy admitted to intensive care.

the place of checkpoint inhibitors (anti-pd-1 and pd-l-1) is currently validated in the management of melanoma and metastatic non-small cell lung cancer. the toxicity profile is specific with adverse effects related to immunity. some side effects (myocarditis, colitis, interstitial lung disease, etc.) can be severe and patient could be hospitalized in intensive care unit. the question of immunotherapy's imputability in the acute disease is becoming more frequent.

Eligibility criteria:
inclusion criteria: * \> or = 18 years old; * with a solid tumor; * treatment with anti-ctla4 and / or anti-pd-1 / pdl-1 still in progress or up to 6 months after stopping; * admitted to resuscitation or continuous care in an unprogrammed way, whatever the reason. exclusion criteria: * minors; * pregnant or lactating woman; * admission after surgery of a scheduled surgery or for the security of procedure; * anti-ctla4 and / or anti-pd-1 / pdl-1 treatment stopped for more than 6 months; * subject under guardianship or deprivation of liberty; * refusal of consent; * no affiliation to a health insurance scheme.

Keywords: cancer intensive care unit checkpoint inhibitors adverse event