Kornimate/medical-research-clean huggingface dataset:
post-market clinical follow-up study of alcon precision1™ spherical and precision1™ for astigmatism soft contact lenses

Conditions: Refractive Errors

Summary: the purpose of this study is to assess long term performance and safety of verofilcon a soft contact lenses in a real-world setting in a population of 7 years or older having at least 1 year of verofilcon a (sphere or toric) contact lens wear in a daily wear and daily disposable modality.

this study consists of a baseline visit and a year 1 visit. the baseline visit is defined as the first office visit where an eye care professional provided an in-person office biomicroscopy exam to the subject before or during which a precision1™ sphere or toric contact lens prescription was released. the baseline visit will be retrospective, with all assessments obtained from chart review. the year 1 visit is defined as the visit that occurs 1 year (-2/+4 months) since baseline during which period the subject is wearing test lenses of the same design in both eyes and a contact lens examination is performed during the visit. the year 1 visit may be prospective or retrospective.

Eligibility criteria:
key inclusion criteria: * subject (or subject's legal representative) is able to understand and sign an informed consent/assent form approved by an institutional review board (irb), unless appropriate consent waiver for the retrospective chart review is provided by the irb. * verofilcon a (sphere or toric) contact lens wear as described in the protocol. * best corrected spectacle distance visual acuity (va) 20/25 or better at baseline. * healthy, non-diseased eyes, as determined/known by the investigator. * other protocol-defined inclusion criteria may apply. key exclusion criteria: * any ocular disease or condition that would contraindicate contact lens wear present at baseline. * use of systemic or ocular medications that would contraindicate contact lens wear at baseline. * other protocol-defined exclusion criteria may apply.

Keywords: myopia hyperopia astigmatism
new onset cardiac arrhythmias in septic patients in critical care setting, predictors and outcomes.

Conditions: Cardiac Arrhythmia

Summary: new onset cardiac arrhythmias in septic patients in critical care setting, predictors and outcomes

sepsis is recently defined as life-threatening condition caused by dysregulated body response to infection leading to organ dysfunction and even death. patients who are vulnerable to catch sepsis are those with immune-compromising diseases, old aged people and chronic medical condition such as diabetes, chronic kidney diseases or cancer. sepsis is symptomized by fever or hypothermia, tachycardia, tachypnea. in critical care units, septic patient are predisposed to have different cardiovascular manifestation as atrial fibrillation, atrial flutter, hypotension, etc. . many studies reported the association between atrial fibrillation and septic patients in critical care as a complication of sepsis; but data regarding factors and fates is still insufficient. so in this study we aim to observe critical ill patients with sepsis to assess and evaluate the predisposing factors leading to new onset of cardiac arrhythmia in septic patients.

Eligibility criteria:
inclusion criteria: * adult patient of 18 years old and above of both gender admitted with manifestation of sepsis. exclusion criteria: * patients below 18 years old. * pregnant females. * patients with cardiac arrhythmia before admission in the critical unit. * patients with previous cardiac surgery.

Keywords: cardiac arrhythmia sepsis critical care
salvage surgeries for splanchnic artery aneurysms after failed endovascular therapies: cases series

Conditions: Failure in Endovascular Therapy; Splanchnic Aneurysm; Mass Effect; Surgery

Summary: a retrospective review was performed for consecutive patients (from 2019 to 2021) who underwent salvage surgeries following failed endovascular therapies for splanchnic artery aneurysms in a tertiary referral center. salvage operations include total aneurysmectomy with vascular reconstruction and partial aneurysmectomy with directly closing bleeders from the intraluminal space of the aneurysms.

salvage surgery for splanchnic artery aneurysm after failed endovascular trials includes one of the following three strategies: (1) aneurysmectomy along with the involved organ if the aneurysm is located within the parenchyma of solid organs (2) aneurysmectomy with vascular reconstruction if the aneurysm outside the solid organ (3)partial aneurysmectomy with direct closing the feeding vessel orifice if the aneurysm occurs in the hostile abdomen.

Eligibility criteria:
inclusion criteria: * patients underwent salvage surgeries following failed endovascular therapies for splanchnic artery aneurysms * the aneurysms were diagnosed based on medical history and computed tomography (ct) exclusion criteria: * patients only underwent endovascular therapies for artery aneurysms * the aneurysms are not located at the splanchnic artery

Keywords: salvage surgery failed endovascular therapy giant aneurysm mass effect jaundice surgery
oxygen toxicity: mechanisms in humans

Conditions: Oxygen Toxicity; Hypercapnia; Seizures

Summary: the goal of this clinical trial is to learn about the mechanisms of oxygen toxicity in scuba divers. the main questions it aims to answer are: * how does the training of respiratory muscles affect oxygen toxicity? * how do environmental factors, such as sleep deprivation, the ingestion of commonly utilized medications, and chronic exposure to carbon dioxide, impact the risk of oxygen toxicity? * how does immersion in water affect the development of oxygen toxicity? participants will be asked to do the following: * undergo a basic screening exam composed of health history, vital signs, and some respiratory function tests * train their respiratory muscles at regular intervals * exercise on a cycle ergometer both in dry conditions and underwater/under pressure in the context of medication, sleep deprivation, or carbon dioxide exposure researchers will compare the performance of each subject before and after the possible interventions described above to see if there are changes in exercise performance, respiratory function, cerebral blood flow, and levels of gene expression.


Eligibility criteria:
inclusion criteria: * equal numbers of male and female * non-smokers * aged 18-45 years * males will be required to have vo2 peak \> or equal to ml/kg min * and females \> or equal to 30 ml/kg min exclusion criteria: * pregnancy * cardiorespiratory disease, including hypertension * neuromuscular disease * anemia * history of hemoglobinopathy, including sick cell disease and trait
neurophysiological measures of auditory perception and rehabilitation in cochlear implanted patients

Conditions: Deafness

Summary: this study aims at investigating new automatic fitting techniques for cochlear implant patients based on objective measures. for this reason, the evolution of these neurophysiological measures, expressing the encoding of pure tones and speech, will be characterized in cochlear implanted patients as a function of post-implantation time and will be compared to those of normal hearing subjects. moreover, the effect of auditory training with new tools based on serious games will be assessed.


Eligibility criteria:
inclusion criteria: * native french speaker * no medical treatment for behavior or neurological disorders * normal or corrected vision * right-handed * normal orl examination * valid affiliation to social security * absence of participation to another study for the cochlear implanted patients: * aged from 1 to 70 * bilateral severe to profound deafness * cochlear implant * congenital deafness, pre or post lingual for the normal-hearing subjects: * aged from 18 to 70 * normal tonal audiometry exclusion criteria: * no signed consent * treatment for depression, epilepsy, parkinson's or alzheimer's disease * physical health deficiency * mental retardation * neurological or psychiatric disease incompatible with the testing procedure * schooling in a foreign language * foreign language spoken at home with both parents * invalid social security * for the normal hearing subjects, no known hearing deficits

Keywords: cochlear implant deafness audiometry speech perception severe to profound deafness restored with cochlear implantation
study of the sensitivity to change of a bimanual 3d analysis protocol for the assessment of upper limb movement in children with cerebral palsy before and after therapies

Conditions: Cerebral Palsy Infantile

Summary: cerebral palsy is the most common cause of motor disability in children. it can lead to a deficit of the upper limb which alters the realization of daily activities, in particular in bimanual situations, and eventually leads to a decrease in their participation. three-dimensional (3d) movement analysis is a tool that provides an accurate and objective measurement of movement. this technology allows us to understand and characterize movement anomalies in order to guide and adapt therapies to the upper limb. the majority of 3d upper limb analysis protocols used to measure the effect of interventions, such as botulinum toxin injections indicated for the treatment of spasticity or other innovative rehabilitative therapies, are unimanual and do not study bimanual function, which is more representative of the actual use of the upper limbs in daily life. recently, a 3d bimanual analysis protocol called "be an airplane pilot" (be-api), taking place in an innovative play context, has been developed and validated in pc children. the 2nd version of the protocol (be api 2.0) also allowed the exploration of new parameters in a bimanual situation such as the fluidity and the trajectory of the movement. in order to determine the interest of the be api 2.0 protocol in routine clinical evaluation of the upper limbs, its sensitivity to change, i.e. its capacity to detect modifications caused by a therapy on the movements of the upper limbs is necessary (e.g.: hand and arm bimanual intensive therapy including lower extremity (habit ile), botulinum toxin injections).


Eligibility criteria:
inclusion criteria: * child between the ages of 5 and 18, * child with cerebral palsy as defined by the csep * level of manipulation sufficient to perform the tasks of the 3d protocol (macs score i to iii included), * for whom the habit-ile therapeutic program and/or botulinum toxin injection is prescribed * affiliated via his/her parents to a social security plan, * no opposition formulated by the holders of parental authority and the child exclusion criteria: * child with unilateral or bilateral spastic cerebral palsy * cognitive deficits hindering the comprehension of instructions or visual disorders not allowing the visualization of the game board, * pain in the upper limb (vas score\>3), * contraindications to the use of botulinum toxins and absence of indications as mentioned in the has 2010 recommendations * patients under legal protection (guardianship, curatorship, ...) * refusal to participate
antepartum betamethasone treatment for prevention of respiratory distress in infants born by elective cesarean section

Conditions: Respiratory Distress Syndrome, Newborn

Summary: this is a randomized, multicenter, double blind, placebo controlled trial of betamethasone versus a placebo given prior to the mothers at term and near term gestation (\>34 and \<40 weeks of gestation) who are scheduled to undergo a planned cesarean section. the study design is to determine the efficacy and safety of betamethasone in the prevention of breathing problems commonly seen in this population. in infants born by elective cesarean section, it is hypothesized that antenatal betamethasone treatment will reduce the risk of neonatal intensive care unit (nicu) admission from 11% to 8% and/or oxygen therapy +/- positive pressure ventilation (ppv) for \>30 minutes from 4.5% to 2.5%.

the purpose of this pilot study is to determine if antepartum betamethasone given to mothers undergoing elective cesarean section (ecs) delivery at term or near term gestation (\>34 and \< 40 weeks of gestation) is safe and feasible in reducing neonatal respiratory morbidity and the related admissions to neonatal intensive care units (nicu). the data from this pilot study will be used to support a nih application for a multicenter randomized trial to determine, if compared to placebo treatment, antenatal betamethasone initiated 2-7 days prior to an ecs results in decreased occurrence of respiratory morbidity and nicu admissions in the newborn. the multicenter protocol was recently reviewed by the nichd network for clinical trial. the reviewers were enthusiastic about the scientific merit and public health importance of the study but asked for a pilot study to determine feasibility before launching the national trial. given the rise in the rate of cs deliveries, we project substantial health cost savings from this preventive strategy if it were found to be successful in reducing neonatal morbidity.

Eligibility criteria:
inclusion criteria: * pregnant women \>/= 34 weeks gestation scheduled to undergo operative delivery within 48-72 hours after study enrollment exclusion criteria: * known contraindication to the use of betamethasone in the mother * known lethal or non-lethal congenital anomaly diagnosed antenatally * spontaneous labor * premature rupture of membranes

Keywords: glucocorticoid antepartum betamethasone treatment elective cesarean section respiratory distress in infants
mechanisms of panic disorders treatment

Conditions: Panic Disorder; Agoraphobia; Panic Attacks

Summary: investigation of mechanisms of exposure based learning by 1. investigating the effects of fear augmentation by interoceptive exposure during in vivo exposure 2. disentangling the effects of interoceptive exposure exercises in panic disorder

the study aims on investigating the effect of fear augmentation during in-vivo exposure by adding interoceptive exposure (e.g., hyperventilation) in pd/ag patients. by comparing the fear augmentation group with the therapist-guided cbt exposure, and by measuring autonomic arousal during and between exposure sessions, it will be possible to study the mechanisms of exposure based learning. a second aim is to disentangle effects of specific interoceptive exposure exercises (e.g., respiratory vs. vestibular stimulation). finally, by including patients without agoraphobic avoidance it will be possible to investigate whether interoceptive exposure alone will have any effect. this might open the door for early interventions for individuals after experiencing an initial panic attack to prevent the development of a severe panic disorder with agoraphobic avoidance.

Eligibility criteria:
inclusion criteria: * age 18-65 years old * diagnostic and statistical manual of mental disorders, fourth edition (dsm-iv) diagnosis of panic disorder, panic disorder with agoraphobia or initial panic attacks * cgi ≥ 4 (except persons with initial panic attacks) * informed consent exclusion criteria: * acute suicidality * current substance use disorder * lifetime diagnosis of psychotic disorders, bipolar disorders, borderline personality disorders * severe medical condition (chronic conditions) * current psychotherapeutic or psychopharmacological treatment

Keywords: panic disorder agoraphobia panic attacks exposure based learning interoceptive exposure exercises fear augmentation in vivo exposure
early treatments for preventing occlusal caries lesions

Conditions: Caries; Initial; Occlusal Caries; Caries,Dental

Summary: sealants effectively arrest non-cavitated caries lesions on the fully erupted occlusal surface of permanent teeth. however, the clinical effectiveness of sealants is uncertain in preventing occlusal caries lesions in partially erupted permanent molars. this study aims to evaluate the progression of caries, the degree of retention, survival rate, and quality of the remnant after applying conventional total-etch resinous sealant and self-etch sealant in erupting molars.


Eligibility criteria:
inclusion criteria: for children: 1. children presenting with good general health and cooperative behavior. 2. children having early caries lesions in a permanent molar (first or second). 3. parents signed informed consent. for permanent molars: 1. early caries lesions on the occlusal surface corresponding to international caries detection and assessment system (icdas) scores 1 and 2. \[ismail ai, sohn w, tellez m, amaya a, sen a, hasson h, pitts nb. the international caries detection and assessment system (icdas): an integrated system for measuring dental caries. community dent oral epidemiol. 2007 jun;35(3):170-8\]. 2. erupting molars: eruption stages 2 (fully erupted occlusal surface with less than half of the crown exposed) and 3 (fully erupted occlusal surface with more than half of the crown exposed). \[carvalho jc, ekstrand kr, thylstrup a. dental plaque and caries on occlusal surfaces of first permanent molars in relation to stage of eruption. j dent res. 1989 may;68(5):773-9\]. exclusion criteria: for children: 1. any allergy reported by the parents. 2. children unable to return for recall visits. for permanent molars: 1. teeth with occlusal surfaces completely covered by the gingival tissue. 2. teeth with hypoplastic defects, restorations, or sealants.

Keywords: early caries lesions sealants erupting molars
stem cell mobilization by g-csf to treat severe peripheral artery disease

Conditions: Peripheral Vascular Diseases

Summary: this study is designed to test the use of g-csf in peripheral vascular disease. the investigators hypothesize that mobilization of angiogenic cells into the blood by granulocyte colony stimulating factor (g-csf) may stimulate the formation of new blood vessels and result in a sustained improvement in blood flow in patients with severe peripheral arterial disease.

one fourth of patients with peripheral artery disease (pad) of the lower extremities have severe symptomatic disease and 1-2% have critical limb ischemia (cli). in patients with cli, the risk of limb amputation at 1 year is 50%. in addition, patients with cli often have rest pain, non-healing ulcers and severe limitations of ambulation. revascularization procedures, including bypass surgery, percutaneous transluminal angioplasty and angioplasty with stenting, are currently the only treatment options. however, many patients are not eligible for a revascularization procedure due to small vessel disease or coexisting medical problems. moreover, restenosis rates are high. there is currently no effective non-invasive treatment for critical limb ischemia. we hypothesize that mobilization of angiogenic cells into the blood by granulocyte colony stimulating factor (g-csf) may stimulate angiogenesis in areas of ischemia and result in a sustained improvement in blood flow in patients with severe pad.

Eligibility criteria:
inclusion criteria: * patients must have critical limb ischemia secondary to pad, as defined by the presence of a non-healing ulcer, rest pain, or dry gangrene. * patients must have a toe pressure ≤ 30 mm hg. * patients must be ≥18 years old. * patient must be able to self-administer a daily subcutaneous injection or have a caregiver who is able to administer a daily subcutaneous injection. * patients must be taking or have no absolute contraindication to taking aspirin and clopidogrel. if they are not currently taking aspirin, they must be willing to take aspirin (81 mg daily) and clopidogrel (75 mg daily) for 14 days starting on the first day of g-csf treatment. * after being informed of the treatment involved, patients must give written consent. the patient should not have any serious medical or psychiatric illness that would prevent either the giving of informed consent or the receipt of treatment. a built-in period of one week from discussion of the trial and initiation of the trial will be mandatory for enrollment. exclusion criteria: * patients with transmetatarsal or higher amputations in the affected limb are excluded. * patients who are candidates for a revascularization procedure.

Keywords: g-csf angiogenesis endothelial progenitor cell limb ischemia revascularization
zilver flex post-market study in japan

Conditions: Peripheral Arterial Disease (PAD)

Summary: japanese post market clinical study of the zilver flex device.


Eligibility criteria:
inclusion criteria: * symptomatic peripheral arterial disease (pad) involving the above-the-knee femoropopliteal arteries exclusion criteria: -

Keywords: drug-eluting stent, paclitaxel-eluting stent, peripheral artery disease, peripheral vascular disease, superficial femoral artery, popliteal artery
study to assess safety,tolerability,pharmacokinetics & antiviral activity of jtk-853 in hepatitis c virus genotype 1 infected subjects

Conditions: Hepatitis C Virus Infection, Response to Therapy of

Summary: the purpose of this study was to determine the safety, tolerability, pharmacokinetics and anti-viral activity of jtk-853 in hepatitis c virus genotype 1 infected subjects based on reduction in viral load (hcv rna level) from baseline to end of treatment, followed by genotypic resistance monitoring for up to one year after study drug treatment.


Eligibility criteria:
inclusion criteria: 1. males and females infected with chronic hepatitis c virus (hcv) infection and genotype 1a or 1b 2. subjects with a viral load (hcv rna level) of ≥50,000 iu/ml 3. subjects with a body mass index (bmi) of 18.0-36.0 kg/m2 (inclusive) exclusion criteria: 1. subjects should not have previously received a direct acting anti-hcv agent 2. subjects should not previously have received pegylated interferon/ribavirin for a duration of more than two weeks

Keywords: hepatitis c jtk-853
a population-based study of drug exposures and adverse pregnancy outcomes in china (deep)

Conditions: Pregnancy; Congenital Malformation; Drug Exposure

Summary: the deep cohort is the first population-based cohort of pregnant population in china that longitudinally documents drug uses throughout the pregnancy life course and adverse pregnancy outcomes.

the deep cohort is the first population-based cohort of pregnant population in china that longitudinally documents drug uses throughout the pregnancy life course and adverse pregnancy outcomes. the main goal of the study aims to monitor and evaluate the safety of drug use through the pregnancy life course in the chinese setting. the deep cohort is developed primarily based on the population-based data platforms in xiamen, a municipal city of 5 million population in southeast china. based on these data platforms, a pregnancy-centered registry was developed that documented health care services and outcomes in the maternal and other departments. for identifying drug uses, a drug prescription database was specifically developed by using electronic healthcare records documented in the platforms across the primary, secondary and tertiary hospitals. by linking the pregnancy registry and prescription database through a unique identifier, the deep cohort was developed. all the pregnant women and their offspring in xiamen are provided with health care and followed up according to standard protocols in the region, including antenatal care, delivery care, postpartum follow-up and childhood follow-ups. the primary adverse outcomes - congenital malformations - are collected using a standardized case report form.

Eligibility criteria:
inclusion criteria: * pregnant women who registered at the maternal and child health management platform in xiamen. exclusion criteria: * none

Keywords: cohort study drug exposures congenital malformation pregnancy population-based