Kornimate/medical-research-clean huggingface dataset:
acrysof iq toric a-code post-market clinical study

Conditions: Cataract; Astigmatism

Summary: the purpose of this study is to clinically confirm the rotational stability of a modified acrysof iq toric intraocular lens (iol) in a japanese population.

patients will be examined pre-operatively to up to 3 years post-operatively. one eligible eye will be selected as a target eye for efficacy analysis. if both eyes are eligible, the eye in which the iol is implanted first will be selected as the target eye.

Eligibility criteria:
inclusion criteria: * diagnosis of cataracts with planned cataract removal by phacoemulsification * calculated lens power within the available range * able to sign informed consent and complete all study visits * other protocol-defined inclusion criteria may apply. exclusion criteria: * eye conditions as specified in the protocol * uncontrolled glaucoma * pregnancy, current or planned * other protocol-defined exclusion criteria may apply.

Keywords: phacoemulsification intraocular lens vision toric
impact of complex care training of hereditary epidermolysis bullosa on caregiver burden (fireb)

Conditions: Hereditary Epidermolysis Bullosa

Summary: hereditary epidermolysis bullosa (ebh) is a rare, orphan disease characterized by skin and mucous membrane fragility. the latest scientific data show that the proposed treatments are still in the experimental stage and that no curative treatment is available. the repercussions of this chronic disease, with neonatal onset, are major. epidermolysis bullosa requires multidisciplinary medical management, nursing care, psychological and social care. skin care involves preventing and treating chronic wounds and identifying their complications. the very great cutaneous-mucous fragility makes these treatments painful, long and complex, the caring hand itself being able to cause new wounds. analgesics of different levels are not effective enough during treatment. along with counseling and education, nursing takes a central role in multi-professional accompaniment interventions to support and relieve families. parents became home caregivers out of necessity, and developed specific skills in epidermolysis bullosa, their child and dressings. they have great and demanding expectations of caregivers facing this rare disease, for which they are not trained in their degree course. despite the severe nature of the disease, few studies have been carried out on the impact and psychosocial consequences on patients and their families, yet there is an expressed need for support. the burden on parents is heavy, assessed by specific scales, but to date there are no studies examining the impact of epidermolysis bullosa care on caregiver stress.


Eligibility criteria:
inclusion criteria: * nurse, nursing assistant, nursery nurse, childcare assistant, state graduates caring for patients with ebh and working at necker hospital. * having participated in the entire training program specific to the complex care of epidermolysis bullosa. * informed and not opposed to their participation in research. exclusion criteria * person under tutorship or curatorship. * other health professionals (physiotherapist, doctor, etc.).

Keywords: hereditary epidermolysis bullosa nursing care care training child
the application of enhanced recovery after surgery (eras) for cardiovascular surgery in the correction of complex congenital heart disease

Conditions: Complex Congenital Heart Disease; Enhanced Recovery After Surgery

Summary: this study is a multicenter, stepwise design, cluster randomized controlled trial. random sequence is generated by computer, and each center enters the intervention expectation (phase i) in random order to implement eras strategy. if it does not enter the intervention expectation (phase c) center, clinical diagnosis and treatment will be completed according to the traditional scheme. among children, patients aged 28 to 6 who underwent cardiac surgery were included in the eras strategy intervention plan, which mainly includes preoperative education, preoperative comfort for the patient, preoperative oral sugary beverage, continuous infusion of dexmedetomidine, multimodal analgesia, blood protection strategies, prevention of postoperative nausea and vomiting, intraoperative insulation, early tracheal extubation and intubation, and targeted liquid therapy. the traditional plan group follows the current clinical diagnosis and treatment routine. by comparing the differences in the incidence of major postoperative outcomes (mace events, major pulmonary complications, and acute kidney injury) between the intervention group and the non intervention group, as well as comparing other adverse events (including but not limited to pneumonia, massive bleeding, postoperative arrhythmia, incision infection, postoperative nausea, vomiting, and delirium), all cause secondary intubation, and all cause secondary surgery between the two groups, and recording hospitalization time, icu stay time the removal time of tracheal intubation and drainage tube, the pain score during hospitalization, the total amount of opioid drug use (converted to the same dose of morphine), hospitalization expenses, and family satisfaction scores were recorded to explore whether the eras regimen can reduce the incidence of major postoperative adverse events, improve patient prognosis, and accelerate postoperative recovery compared to traditional regimens.


Eligibility criteria:
inclusion criteria: * patients aged 28 days to 6 years * patients awaiting elective cardiac surgery with cardiopulmonary bypass (cpb). exclusion criteria: * the risk adjustment for congenital heart surgery (rachs) is above class 5 * patients with cardiac assist device, mechanical ventilation or the history of asphyxia * patients with pulmonary disease, including respiratory tract infections and asthma * patients with severe liver or renal dysfunction, including severe acute or chronic renal dysfunction need renal replacement therapy, and acute or chronic liver failure need artificial liver therapy * fetal malformation includes polysplenia syndrome, asplenia syndrome, down syndrome, digeoge syndrome, marfan syndrome, trachea-bronchus stricture, diabetes, nervous functioning disorders, genital system malformations, imperforate anus, and williams syndrome * current enrollment in another clinical trial * guardian's refusal or low adherence
echocardiography-guided oval-shaped asd closure

Conditions: ASD II; Percutaneous Closure; Zero-fluoroscopy

Summary: background: an atrial septal defect (asd) is considered oval-shaped when its shortest diameter is less than 75% of its longest diameter. research on the percutaneous closure of oval-shaped asds is limited, and to our knowledge, there are no reports of non-fluoroscopic closure for this specific population. objective: to assess the effectiveness of non-fluoroscopic percutaneous closure for oval-shaped asds. methods: this single-center, retrospective study examines patients undergoing percutaneous closure of oval-shaped asds using a non-fluoroscopy technique for initial decision-making. the device was selected to be approximately 0-4 mm larger than the longest diameter of the defect, based on measurements from transthoracic and transesophageal ultrasound.

background: an atrial septal defect (asd) is considered oval-shaped when its shortest diameter is less than 75% of its longest diameter. research on the percutaneous closure of oval-shaped asds is limited, and to our knowledge, there are no reports of non-fluoroscopic closure for this specific population. objective: to assess the effectiveness of non-fluoroscopic percutaneous closure for oval-shaped asds. methods: this single-center, retrospective study examines patients undergoing percutaneous closure of oval-shaped asds using a non-fluoroscopy technique for initial decision-making. the device was selected to be approximately 0-4 mm larger than the longest diameter of the defect, based on measurements from transthoracic and transesophageal ultrasound.

Eligibility criteria:
inclusion criteria: * oval-shaped secundum asd with evidence of right ventricular overload, no significant and irreversible pulmonary arterial hypertension, no significant arrhythmia, no serious problems in other organs, and presumption of appropriate rims for device implantation exclusion criteria: * other than stated in inclusion criteria
efficiency and safety a fixed combination of orphenadrine and diclofenac for postoperative analgesia

Conditions: Analgesia

Summary: the study will include 60 patients after cardiac surgery. the first group will include 30 patients who will use the drug neodolpasse manufactured by fresenius kabi, which is a fixed combination of 30 mg of orphenadrine and 75 mg of diclofenac; the second group will consist of 30 patients who will use patient-controlled morphine analgesia (рса) in the form of monotherapy.

the patient signs an informed consent to participate in the study after tracheal extubation.the application of one or another method of influence is carried out by the method of random sampling (the envelope method). the drug neodolpasse is used according to the following plan: in the form of an intravenous infusion of 250 ml for 2 hours 1 or 2 times a day with intervals between infusions about 12 hours. the second injection will be prescribed at vas \> 40 mm no earlier than 12 hours after the first. the first injection will begin immediately after tracheal extubation. morphine analgesia controlled by the patient will begin 2 hours after tracheal extubation (the concentration of the drug will be 1 mg /ml; the initial or loading dose is 3 mg; the bolus dose was 1 mg; the lockout interval is 6 minutes; the 4-hour maximum dose is 10 mg; the rate of constant infusion is 0.1 mg / hour).

Eligibility criteria:
inclusion criteria: 1. age from 18 years to 80 years inclusive 2. surgical access - median sternotomy 3. the first 2 hours after tracheal extubation 4. clear consciousness and productive contact with the patient 5. absence of erosive or ulcerative lesions of the mucous membrane of the esophagus, stomach and duodenum during preoperative esophago-gastro-duodenoscopy and clinical manifestations of gastrointestinal bleeding 6. no signs of renal dysfunction (kdigo 0) 7. stable state of hemodynamics exclusion criteria: 1. a history of mental illness 2. the presence of contraindications to the appointment of diclofenac and orphenadrine or individual intolerance to drugs of these groups 3. renal and hepatic insufficiency 4. perioperative brain lesions 5. postoperative bleeding\>1.4 ml/kg/hour 6. severe cardiovascular (inotropic index\>10) and/or respiratory (rao2 /fio2\<200 mmhg) insufficiency

Keywords: analgesia, non-opioid, patient-controlled analgesia
biomarkers in patients with pneumonia

Conditions: Pneumonia

Summary: to identifying biomarkers in patients with pneumonia

the aim of this study is to identify the biomarkers in patients with pneumonia. these biomarkers can distinguish community-acquired pneumonia, hospital-acquired pneumonia, severe pneumonia, bacterial infection, virus infection and fungal infection. furthermore, these biomarkers can identify the efficacy of treatment in patients with different interventions.

Eligibility criteria:
inclusion criteria: healthy patients without any diseases - exclusion criteria:age less than 18 years -
analysis of the effectiveness of visual training in stroke rehabilitation

Conditions: Stroke, Subacute

Summary: the study was a randomized control trial conducted to determine whether vr games incorporated with cognitive engagement within visual training feedback are feasible intervention options in stroke rehabilitation. an investigation has been conducted to assess the efficacy of virtual reality games that enhance hand motor functions to attain long-lasting improvements. patients were randomly assigned to the experimental and control groups. each patient's therapy consists of 24 sessions, with each session lasting 4 days per week, for a total duration of 6 weeks. developed four vr-based hand games that include hitting a rolling ball, grasping a balloon, swapping hands, and gripping a pencil.

the field of stroke rehabilitation frequently faces limitations in therapies and struggles to achieve long-lasting improvements in hand motor function. the integration of fully immersive virtual reality (vr) games with visual training feedback significantly improves the efficacy of stroke rehabilitation. virtual reality (vr) games that incorporate repetitive and particular tasks stimulate the gradual activation of brain pathways linked to motor activities. vr research has the potential to enhance vr intervention games by combining cognitive engagement with visual feedback. the objective of this study was to develop and evaluate virtual reality games that utilize an approach of cognitive engagement within visual feedback in order to enhance hand-motor capabilities. the study utilized completely immersive virtual reality (vr) games specifically designed for subacute stroke patients. the implementation of fully immersive virtual reality (vr) games as an intervention proved to be highly effective in significantly maintaining the motor recovery of patients who had experienced a stroke in the subacute phase. stroke patients exhibited enhanced dexterity, heightened range of motion, greater hand strength, and improved grip. developed vr games utilize a virtual reality device and are designed to be controlled by hand movements such as flexion/extension, close/open, supination/pronation, and pinch. patients were randomly assigned to the experimental and control groups. the experimental group received a vr hand game intervention with conventional physical therapy, while the control group only received conventional physical therapy. each patient's therapy consists of 24 sessions, with each session lasting 4 days per week for a total duration of 6 weeks.

Eligibility criteria:
inclusion criteria: * montreal cognitive assessment (moca ≥ 21) * modified ashworth scale (mas\< 4) * fugl-meyer assessment (fma between 25 and 55) * age ≥ 18 years * stroke patient type (subacute patients) exclusion criteria: * wrist impairments * contractures * patients with vestibular issues * permanent external fixation

Keywords: vr games visual feedback intervention stroke
cbct-guided navigational bronchoscopy for lung nodules

Conditions: Peripheral Pulmonary Nodules; Lung; Node; Cone Beam Computed Tomography; Guided Navigation Bronchoscopy

Summary: the purpose of this study is to determine if the cone beam computed tomography (cbct)-guided navigation bronchoscopy is better in diagnosing lung nodules compared to navigation bronchoscopy alone.

this clinical trial examines the effectiveness of a treatment comparing it to another known treatment. the u.s. food and drug administration (fda) has approved the navigation bronchoscopy as a treatment option for this disease. the u.s. food and drug administration (fda) has approved the cone-beam ct scan as a treatment option for this disease. this research study involves a screening period, a procedure and follow up visits. the names of the study interventions involved in this study are: * computed tomography (cbct)-guided navigation bronchoscopy (cbct-guided nb) * navigation bronchoscopy alone participants will receive the study procedure and will be followed for up to 6 months. it is expected that about 136 people will take part in this research study.

Eligibility criteria:
inclusion criteria: * participants ≥18 years old. * participants with lesions having an intermediate pre-test probability of malignancy (pca, 0.05 to 0.65) as determined by swensen-mayo nodule risk calculator and in whom bronchoscopic biopsy was determined to be the next best treatment step by the treating pulmonologist. * participants with higher risk lesions (pca \> 0.65) in need of a diagnosis for nonsurgical treatment or prior to surgery. * participants are willing and able to provide informed consent. exclusion criteria: * the participant is pregnant as confirmed by urine or serum pregnancy testing. * there is a predetermined plan to pursue stereotactic body radiation therapy (sbrt) in the event of a nondiagnostic study procedure in participant's with a nodule in the outer 1/3 lung zone (i.e. the participant would not go on for a ct guided ttna). * lacked fitness according to physician judgement to undergo bronchoscopy. * contraindication for temporary interruption of the use of anticoagulant therapy. * uncontrolled or irreversible coagulopathy. * known allergy for lidocaine. * uncontrolled pulmonary hypertension. * recent (\< 4 weeks) and/or uncontrolled cardiac disease. * compromised upper airway (eg concomitant head and neck cancer or central airway stenosis such that endobronchial access is considered unsafe). * asa classification ≥ 4. * covid-19 positive participant at the time of procedure.

Keywords: peripheral pulmonary nodules lung; node cone beam computed tomography guided navigation bronchoscopy
evaluation of the retinal health monitoring system thickness module

Conditions: Macular Edema; Macular Degeneration

Summary: evaluate the ability and accuracy of the retinal health monitoring system - retinal thickness module (rhms - rtm).

evaluation of the retinal health monitoring system - retinal thickness module in subjects with normal macular thickness and subjects with center-involving macular edema.

Eligibility criteria:
inclusion criteria: 1. age ≥50. 2. corrected visual acuity (va) of 20/125 or better, in the study eye(s) 3. media clarity, undilated pupil size, and subject cooperation sufficient to obtain adequate oct b-scans in the study eye(s) 4. able to perform self-testing of retinal thickness with the rhms-rtm after training 5. able and willing to provide written informed consent before undergoing any study-related procedures 6. group 1: macula with normal thickness \[central subfield thickness (cst): \<305μm in women, and \<320μm in men as measured by heidelberg spectralis sd-oct in at least one eye. patients diagnosed with dry amd are eligible for enrollment into group 1. no history of wamd, dr, or rvo in either eye 7. group 2 and group 3, in at least one and the same eye: history of center-involving macular edema due to wamd (group 2); or dr or rvo (group 3); macular edema on sd-oct with cst ≥305 μm in women, and ≥320μm in men as measured by heidelberg spectralis sd-oct. exclusion criteria: 1. history of corneal refractive surgery \[e.g., laser-assisted in situ keratomileusis (lasik), photorefractive keratectomy (prk), radial keratotomy (rk)\] in the study eye(s) 2. history of epiretinal membrane, vitreomacular traction, or macular hole in the study eye(s) 3. participation in any study using an investigational drug within 30 days of screening or an investigational device within 60 days of screening 4. refractive error within defined limits 5. history of photocoagulation laser scar or other retinal scar in the central 3 mm of the macula, in the study eye(s)

Keywords: age-related macular degeneration macular edema retinal vein occlusion diabetic macular edema
contrast medium volume and contrast-induced nephropathy after percutaneous coronary intervention

Conditions: Contrast Induced Nephropathy

Summary: to investigate the predictive value of the contrast media volume to creatinine clearance (v/crcl) ratio for the risk of contrast-induced nephropathy (cin) (i.e., within 48-72 h) and to determine a relatively safe v/crcl cut-off value to avoid cin in patients following pci

contrast media volume to creatinine clearance (v/crcl) ratios were obtained from consecutive consenting patients after unselective pci. receiver-operator characteristic (roc) curves were used to identify the optimal sensitivity for the observed range of v/crcl. the predictive value of v/crcl for the risk of cin was assessed using multivariate logistic regression.

Eligibility criteria:
inclusion criteria: * patients who agreed to stay in the hospital for 2-3 days after percutaneous coronary intervention * provided written informed consent * creatinine clearance:15-60ml/min exclusion criteria: * pregnancy * lactation * intravascular administration of an contrast medium within the previous seven days * treatment with metformin * aminoglycosides * n-acetylcysteine (nac) * nonsteroidal anti-inflammatory drugs within the previous 48 h * intake of nephrotoxic drugs within the previous seven days * history of serious reactions to contrast mediums * severe concomitant disease * renal transplantation , or end-stage renal disease necessitating dialysis patients who died during percutaneous coronary intervention

Keywords: contrast-induced nephropathy contrast medium creatinine clearance percutaneous coronary intervention
european extension study to evaluate safety and efficacy of ctp-543 in adults with alopecia areata

Conditions: Alopecia Areata

Summary: the overall objectives of the study are to evaluate long-term safety of ctp-543 and to assess long-term effects of ctp-543 on treating hair loss in adult patients with chronic, moderate to severe alopecia areata. patients from european sites who previously completed a qualifying ctp-543 clinical trial may participate in this study.


Eligibility criteria:
inclusion criteria: * have completed 24 weeks of treatment in a previous qualifying ctp-543 clinical trial exclusion criteria: * active scalp inflammation, psoriasis, or seborrheic dermatitis requiring topical treatment to the scalp, significant trauma to the scalp, or untreated actinic keratosis * females who are nursing, pregnant, or planning to become pregnant while in the study, and for 30 days after last dose of study medication * donation of blood at any point throughout the study and for 30 days after last dose of study medication
capnometry-assisted breathing training for copd

Conditions: Chronic Obstructive Pulmonary Disease

Summary: capnometry-assisted breathing training for copd (catch) is a behavioral intervention that aims to promote optimal, self-regulated, mindful breathing. a portable capnometer is used in-session to provide continuous visual feedback of respiratory rate (rr), end-tidal carbon dioxide tension (etco2), and breathing pattern. the tailored catch intervention will emphasize a slow, quiet, regular, nasal breathing pattern, as well as pursed lips breathing (plb). catch is once weekly for 6 weeks, for a total of 6 sessions; each session is approximately 60 minutes long. the principal investigator will implement the catch intervention. the principal investigator will implement the catch intervention. patients will use the address stress app on a smart phone or computer tablet as part of their home breathing exercises.


Eligibility criteria:
inclusion criteria: * over 40 years of age * has copd documented in their electronic medical record, as defined by fev1/fvc of \< 0.70 on pulmonary function testing (spirometry), or as shown on a chest ct * can maintain oxygen saturation (sao2) ≥ 90% on room air at rest * is medically cleared to participate in nyulmc's outpatient pulmonary rehabilitation program * english speaking. pregnant patients will not be enrolled in the study exclusion criteria: * requires 24-hour supplemental oxygen * has cognitive impairment as measured by ≤23/30 on the mini mental state examination (mmse) * is actively being treated for lung cancer (e.g. with chemotherapy or upcoming surgery) * has morbid obesity (bmi \> 40) * is currently smoking * has unstable cardiac disease defined by a history of a myocardial infarction in the past 3 months