rjac/clinicaltrials.gov-summary_and_eligibility huggingface dataset:
Safety and Effectiveness of Cochlear Implantation in an Expanded Adult Population
Status: Not yet recruiting

This study aims to evaluate the safety and efficacy of cochlear implantation for adults with bilateral sensorineural hearing loss who currently do not meet the FDA-approved indications for cochlear implantation. Following cochlear implantation, participants will complete speech perception assessments and questionnaires over the course of seven visits.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Individuals 18 or older at the time of consent Meets the following audiometric criteria for the ear to be implanted: clinically established sensorineural hearing loss (SNHL) defined by a four frequency pure tone average (PTA) at 500, 1000, 2000, & 4000 Hz of: ≥60 dB HL and compromised functional hearing in the aided condition defined as <50% correct on a word recognition test Meets the following audiometric criteria for the non-implanted contralateral ear: clinically established SNHL defined by a four frequency PTA at 500, 1000, 2000, & 4000 Hz of >30 dB HL Candidate is a fluent speaker in the language used to assess speech perception performance as determined by the investigator. Willing and able to provide written informed consent.  Exclusion Criteria:  Meets current indications on audiometric thresholds for traditional adult CI candidates (i.e., bilateral moderate to profound hearing loss in the low frequencies and profound [≥ 90 dB HL] hearing loss in the mid to high speech frequencies) Absence of cochlea development or a cochlear nerve Presence of active middle ear infection in the ear to be implanted Tympanic membrane perforation in the presence of active middle ear disease in the ear to be implanted Medical or psychological conditions that contraindicate general anaesthesia, surgery, or participation in the clinical investigation. Existing contralateral cochlear implant or medical plan to implant a contralateral cochlear implant during the clinical investigation. Pregnant or breastfeeding women. Women who plan to become pregnant during the course of the clinical investigation. Unrealistic expectations on the part of the participant, regarding the possible benefits, risks, and limitations that are inherent to the surgical procedure(s) and prosthetic devices as determined by the investigator. Additional disabilities that may affect the participant's participation of safety during the clinical investigation. Unable or unwilling to comply with all of the requirements of the clinical investigation as determined by the investigator. Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling. Employees of Cochlear. Current participation, or participation in another interventional clinical study/trial in the past 30 days, involving an investigational drug or device (unless the other investigation was/is a Cochlear sponsored investigation and determined by the investigator or Sponsor to not impact this investigation. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Accelerated Flap Coverage in Severe Lower Extremity Trauma
Status: Not yet recruiting

The goal of this randomized controlled trial is to determine if accelerated flap coverage compared to standard flap coverage timing leads to improved infection-related complications in patients with open fractures and/or dislocations below the knee. Eligible patients will be randomized to receive either a flap within a goal of 72 hours of injury or standard of care flap timing for the institution. The primary outcome will be a composite outcome to evaluate clinical status 6 months after randomization. Components of the composite outcome will be hierarchically assessed in the following order: 1) all-cause mortality, 2) amputation related to injury, 3) re-operation for infection and/or flap complication (flap compromise, partial and/or complete flap failure), and 4) days in hospital, defined as days in an acute in-patient hospital (i.e., not rehab or nursing facility).

Eligibility:
- EligibilityCriteria: The inclusion criteria are:  Patients 18 years of age or older. Severe lower extremity open fracture and/or dislocation below the knee requiring an acute flap for management of the musculoskeletal injury. Will have all planned musculoskeletal injury surgeries performed by a participating surgeon or delegate. Able to be randomized within 48 hours of injury. Site anticipates being able to implement the accelerated flap protocol due to temporary local logistics.  The exclusion criteria are:  Primary amputation anticipated prior to attempted flap for management of the injury. Critical limb ischemia that requires re-vascularization for limb perfusion. Chronic or acute infection at or near the musculoskeletal injury site at the time of initial injury surgery. Burns at the musculoskeletal injury site. Incarceration. Currently enrolled in a trial that does not permit co-enrollment. Declined to provide informed consent. Unable to obtain informed consent due to language barriers. Unable to obtain informed consent because a legally authorized representative was unavailable. Anticipated problems, in the judgment of research personnel, with maintaining follow-up with the patient. Prior enrollment in the trial. Other reason to exclude the patient, as approved by the Methods Centre. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Evaluation of Functionality of Amputees According to the Medicare Functional K Classification System
Status: Recruiting

The aim of our study is; To evaluate the functionality of lower extremity unilateral amputees, to ensure that the results of the Medicare Functional K Classification System, which provides subjective data for the evaluator, become an objective evaluation method and to determine the functional levels of unilateral amputees; To create an objective data set by applying one-leg standing test, ten meter walking test, L test, figure-8 walking test, joint range of motion, amputee mobility estimator scale, houghton scale and joint position sense evaluation tests.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Unilateral lower extremity amputation, Being using a prosthesis, Being literate, Being between the ages of 18-65, Having a healthy stump, Using your current prosthesis in daily living activities,  Exclusion Criteria:  Bilateral lower extremity amputation Unilateral or bilateral amputation of the upper extremity, Having a cognitive or mental problem, Having serious hearing and vision problems, The individual has an orthopedic disease other than amputation, Having an uncontrolled neurological and systemic systemic disease, - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult
Registry on Luma Vision's VERAFEYE System (ENLIgHT)
Status: Not yet recruiting

The objective of the study is to compile real-world data on the use of the VERAFEYE System in standard of care atrial fibrillation (AF) ablation procedures and left atrial appendage closure (LAAC) procedures.

Results from this study will be used to guide development of the VERAFEYE System.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Subject is 18 years of age or of legal age to give informed consent specific to state and national law at the time of consent Subjects is indicated for an atrial fibrillation ablation and/or a left atrial appendage closure procedure with the VERAFEYE System as intracardiac echocardiography imaging system, per physician discretion; Subject is able to understand and willing to provide written informed consent Subject is able and willing to complete all study assessments at an approved clinical investigational center  Exclusion Criteria:  Subject is contraindicated for intracardiac echocardiography (ICE) catheter placement or placement of VERAFEYE Imaging Catheter is technically not feasible per physician discretion Any known contraindication to intracardiac echocardiography imaging, including those listed in the system instructions for use Subjects with an indication for intracardiac echocardiography imaging that is not according to the system instructions for use Pregnant women or women who plan to become pregnant during the course of their participation in the study (women should either be of non- childbearing potential at the time of enrolment (as documented in the medical file) or have a negative pregnancy test within the previous 7 days prior to the procedure) Subjects who are currently enrolled in another study that would directly interfere with this study - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Subjects will be recruited from the investigator's general patient population. Subjects considered for participation in this study will be entitled to undergo a standard of care AF ablation and/or LAAC procedure. - SamplingMethod: Non-Probability Sample
To Assess With Ezefeno Tab. in Patients With Dyslipidemia and T2DM
Status: Not yet recruiting

The goal of this observational study is to assess in the long term efficacy and safety of ezefeno. The primary endpoint are:

major adverse cardiovascular events within 48 months of the trial duration
microvascular events within 48 months of the trial duration

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients with type 2 diabetes diagnosed by American Diabetes Association criteria Age ≥ 19 years Non-HDL-C ≥100 mg/dL, TG ≥200, <500 mg/dL on moderate-intensity statins with cardiovascular risk factor  Exclusion Criteria:  Pregnant or breastfeeding women Uncontrolled hyperglycemia(more than 12.0% for Subject treated with anti-diabetic treatment.) Patient with myopathy and rhabdomyolysis AST/ALT more than 3 ULN Clinical evidence of genetic disorders such as galactose intolerance, Lapp lactose deficiency, and/or glucose-galactose malabsorption - Gender: All - MinimumAge: 19 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Patients with type 2 diabetes, Dyslipidemias - SamplingMethod: Probability Sample
The Effect of Spinal Column Flexion on Unilaterality of Spinal Anesthesia
Status: Not yet recruiting

The effect of two different positions on spinal anesthesia in hip fracture surgery

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  ASA 1-2-3 Hip fracture 18-85 Age BMI: 18-40  Exclusion Criteria:  ASA score of 4 and above Left ventricular ejection fraction below 40% Severe aortic valve stenosis Obesity (BMI >40) Presence of cardiac arrhythmia Having peripheral vascular disease Failure of spinal block Bleeding diathesis - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 85 Years - StdAgeList: Adult, Older Adult
Two-period Crossover Study to Demonstrate the Comparability of Pharmacokinetics of Subcutaneous Ianalumab Between 2mL Auto-injector/2mL PFS with1mL Pre-filled Syringe in Adult Participants With Autoimmune Disease
Status: Not yet recruiting

The purpose of this study is to demonstrate the comparability of ianalumab exposure following the sub-cutaneous (s.c.) administration of one injection of 300 mg/2 mL auto-injector (AI) versus two injections of 150 mg/1 mL pre-filled syringe (PFS), and to evaluate the safety and tolerability of ianalumab following the s.c. administration of both devices in participants with rheumatoid arthritis (RA), Sjögren's disease (SjD), or systemic lupus erythematosus (SLE).

A second optional cohort may be included with the objective of demonstrating the comparability of pharmacokinetics of ianalumab between 1 x 2 mL Pre-filled Syringe (PFS) and 2 x 1 mL PFS.

Eligibility:
- EligibilityCriteria: Key Inclusion criteria:  Signed informed consent must be obtained before any assessment is performed. Male and female patients aged 18 years to 70 years (inclusive). Body weight at least 35 kg and not more than 150 kg and must have a body mass index (BMI) within the range of 18 - 35 kg/m2. BMI = Body weight (kg) / [Height (m)]2 at screening. Diagnosed with RA, SjD and/or SLE as determined by the investigator. Have active disease (RA, SjD or SLE) that may benefit from B-cell depletion therapy, as determined by the investigator. Participants currently receiving protocol-allowed SoC should be on stable doses of SoC medications for 4 weeks prior to first dosing of study treatment. Ability to communicate well with the investigator, understand and agree to comply with the requirements of the study.  Key Exclusion criteria:  Use of prohibited therapies. Active viral, bacterial or other infections requiring systemic treatment at the time of screening or baseline or history of recurrent clinically significant infection. Plans for administration of live vaccines during the study period. Uncontrolled co-existing serious disease. Pregnant or nursing (lactating) women. Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, refusing or unable to use highly effective methods of contraception while on study treatment and for 6 months after stopping of study drug. US (and other countries, if locally required): sexually active males unless using barrier protection during intercourse with women of child-bearing potential while taking study treatment.  Other protocol-defined inclusion/exclusion criteria may apply. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 70 Years - StdAgeList: Adult, Older Adult
The Effect of Mindfulness Practice on Coping With Primary Dysmenorrhea on Pain and Anxiety Level
Status: Recruiting

The aim of this project is to determine the effect of mindfulness practice to cope with dysmenorrhea on pain and anxiety levels. The project will be carried out in a semi-randomized controlled manner. It will be applied to 100 students with dysmenorrhea (100 students by increasing by 10%, taking into account the losses that may occur in the 90 students determined in the sample calculation). Students who meet the inclusion criteria and approve of participating in the project will be given a pre-test before the application. 'Introductory Information Form', 'VAS Scale' and 'State and Trait Anxiety Scale' will be used in the pre-test. After the pre-test, mindfulness practice will be applied for 8 weeks (1 day/120 minutes per week). At the end of 8 weeks, an intermediate test will be performed in the first 3 days of the first menstrual cycle. After the mid-term test, students will practice mindfulness on their own with the brochures provided. Motivational messages will be sent to students for mindfulness practice, starting 3 days before their cycle. The final test will be administered 3 months after the intermediate test. 'VAS Scale' and 'State and Trait Anxiety Scale' will be used in the mid-test and post-test.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Being over 18 years old, Being literate, Having dysmenorrhea, Volunteering to participate in the study, Participating in mindfulness practice for 8 weeks, Not using any pharmacological or non-pharmacological methods, Studying at Bartin University  Exclusion Criteria:  Not being a university student Not experiencing dysmenorrhea Not attending at least two mindfulness practices - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Female - GenderBased: Yes - GenderDescription: Female students who are 18 years of age or older studying at the university will be included. - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Understanding and Treating Traumatic Brain Injury (TBI) Associated Photophobia With Botulinum Toxin Type A (BoNT-A)
Status: Not yet recruiting

The purpose of this research is to understand and treat Traumatic Brain Injury (TBI) associated photophobia (light sensitivity) and its impact on visual function.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Recruit and enroll male and female subjects, civilians and veterans (1:1 mix anticipated, i.e., n = 25 from each group) of all races and ethnicities. ≥18 years of age who are able to consent. Report chronic photophobia (Numerical Rating Scale ≥4 on a 0-10 scale, photophobia present ≥6 months) with a remote history of TBI (>1 year). Inclusion into the study with regard to TBI status will be based on the Department of Defense Standard Surveillance Case Definition for TBI Adapted for Armed Forces Health Surveillance Division (AFHSB) Use. This can include one hospitalization or outpatient medical encounter with documented International Classification of Diseases (ICD9/ICD10) codes as identified within the Surveillance Case Definition. Subjects must also have been on a stable medication regimen for the past 3 months and must be naïve to BoNT-A treatment for orofacial conditions. English as primary language (by self-report).  Exclusion Criteria:  Individuals with ocular diseases that may confound photophobia, such as glaucoma, corneal and conjunctival scarring, corneal edema, uveitis, iris transillumination defects, retinal degeneration, etc. Patients who are participating in another study with an investigational drug within one month prior to screening. Pregnant individuals. Pregnant subjects will not be scanned in the functional Magnetic Resonance Imaging (fMRI). Although there are no known risks associated with MRI during pregnancy, according to facility policy, University of Miami will not scan someone that is pregnant. Therefore, all women of childbearing potential (menstruating or >12 years old) must complete a for stating that are not pregnant within 24 hours of each MRI scan. Individuals with contraindications to fMRI scanning (e.g. metal implants, pacemaker) will not be offered inclusion. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Enoxaparin for Preventing the Radical Artery Occlusion After the Transradial Access Hepatic Arterial Infusion Chemotherapy
Status: Recruiting

The present investigation is designed as a single-blind, randomized, controlled, bicentric trial. The objective is to ascertain whether the subcutaneous administration of enoxaparin sodium for prophylactic anticoagulation during transradial hepatic arterial infusion chemotherapy (HAIC) can diminish the incidence of radial artery occlusion (RAO) post-procedure

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Signed informed consent; Age: 18-69 years; Pathologically diagnosed with hepatocellular carcinoma or clinically in accordance with the American Association for the Study of Liver Diseases (AASLD) diagnostic criteria for hepatocellular carcinoma; Clinical stage: BCLC stage B or C, liver function Child-Pugh class A or B$ (≤7 points)$, ECOG $score <2$; suitable for HAIC treatment; Adequate hematological and organ function, i.e., based on laboratory results obtained within 7 days before treatment, such as complete blood count, liver and kidney function, coagulation function, myocardial enzymes, etc., to assess whether the patient is suitable for HAIC treatment; Low-risk patients for VTE (Venous Thromboembolism) according to the Padua scoring system (≤3 points).  Exclusion Criteria:  Concomitant primary tumors of other organs or histologically diagnosed tumors inconsistent with hepatocellular carcinoma; Serious diseases of the heart, lungs, kidneys, or other organs; Patients who have received trans-radial interventional surgery within the past 3 months; Patients with thrombocytopenia $and/or $leukopenia due to cirrhosis-related coagulation disorders or splenic hyperfunction are excluded; Preoperative radial artery ultrasound suggests vascular anatomical abnormalities, malformations, etc., unsuitable for trans-radial interventional treatment; Patients with thrombotic diseases who are undergoing anticoagulation therapy; Any unstable conditions or situations that may jeopardize the patient's safety or their compliance with the study; Pregnant and lactating women. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 69 Years - StdAgeList: Adult, Older Adult
The Importance of Discharge Education for Mommy Blues
Status: Recruiting

The study will be conducted with participants who will give birth at Farabi Training and Research Hospital in Darıca District, Kocaeli Province.

The sample size of the study was calculated using the G*Power 3.1.9.2 program, and the effect size of the Edinburgh Postnatal Depression Scale (EPDS) score in the Sun et al. (2021) study was considered in the effect size calculation. In the relevant article, the effect size is reported as effect size: 0.47. In our planned research, the minimum number of individuals to be sampled was calculated using G*Power 3.1.9.2 with effect size: 0.47 α= 0.05, power: 0.80, and the sample size was set at a minimum of 57 participants in each group. In anticipation of possible data loss, the study will be completed with a total of 140 participants, including 70 cases and 70 routine discharge training groups. This research aims to determine the effect of discharge training on maternal blues and postpartum depression on the levels of maternal blues and postpartum depression during postpartum follow-up.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  38-42. Those who gave birth between weeks of gestation, Those who have had vaginal birth or caesarean section, Able to speak and understand Turkish, Those over 18 years of age, Mothers with a single healthy baby Those with an Edinburgh Postnatal Depression Scale score of 9 or less in depressive symptoms screening  Exclusion Criteria:  Preterm or postterm birth, Received psychiatric treatment or used psychotropic medications during pregnancy, Having a history of substance dependence and/or use in the past 6 months, Being in the high-risk category, Interventional/instrumented birth (Kiwi, vacuum, crystal maneuver), Mothers having babies with congenital malformations requiring intensive care intervention (small for gestational age, mort de fetus, fetus without major pathology according to ultrasonography). Participants who wish to withdraw from the study at any time will not be included in the study. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Female - GenderBased: Yes - MinimumAge: 18 Years - MaximumAge: 45 Years - StdAgeList: Adult