cyrilzakka/clinical-trials huggingface dataset:
Foveal Sparing of the ILM

To compare the retinal sensitivity of complete internal limiting membrane (ILM) peeling versus foveal sparing ILM peeling during vitrectomy for epiretinal membrane or macular hole.


Eligibility Criteria:
Inclusion Criteria:

* provision of written informed consent
* age \> 60 years
* presence of idiopathic macular pucker or macular hole documented by OCT

Exclusion Criteria:

* any prior intraocular surgery
* pathologic myopia (\> 7 diopters)
* age related macular degeneration
* glaucoma and diabetic retinopathy or any other retinal vascular disease
Salivary Profiling in Infants Treated for Suspected Sepsis: The SPITSS Study

The aim of this study is to develop a faster, safer, and more accurate method for determining if a newborn has an infection. This study involves analyzing saliva for markers of infection and inflammation known as cytokines. We will analyze infant's saliva repeatedly for inflammatory biomarkers (cytokines) within the first 36 hours of their standard of care treatment. We hypothesize that levels of these cytokines will more quickly predict which babies are truly infected and which babies are not compared to the blood tests currently being used.

Specific Aim 1: Develop a predictive model of neonatal infection based upon the expression profile of six salivary inflammatory biomarkers, CRP, procalcitonin, tumor necrosis factor-alpha (TNF-α), and interleukins (IL) 1β, 6, and 8, within the first 36 hours of treatment. Serial saliva samples collected at the initiation of antibiotic therapy and 18-36 hours into treatment from 2,250 neonatal 'rule out sepsis' evaluations will undergo multiplexed quantification of the six salivary inflammatory biomarkers. Diagnostic accuracy will be calculated and predictive models will be developed, incorporating clinical, demographic, and biomarker data.

Specific Aim 2: Validate the predictive model of neonatal infection developed in Aim 1 on an external cohort of newborns. Serial saliva samples from an additional, prospective cohort of 1,750 infants undergoing a 'rule out sepsis' evaluation will be collected to test the validity of the predictive model for neonatal infection.

Specific Aim 3: Establish normative salivary reference ranges of the inflammatory biomarkers across varying gestational ages and weights, and assess the potential of these biomarkers to predict other neonatal morbidities. Salivary samples from the subset of uninfected newborns from Aims 1 and 2 will be combined and used to establish the 95% reference intervals of the salivary inflammatory biomarkers at each time point. Salivary profiles will be correlated to discharge diagnoses (i.e. bronchopulmonary dysplasia, periventricular leukomalacia) to assess the ability of each biomarker, alone and in combination, to predict neonatal morbidities known or hypothesized to be associated with an inflammatory response.

Eligibility Criteria:
Inclusion Criteria:

Neonates \< 43 weeks' gestation, currently admitted to the NICU or well-baby nursery.

Exclusion Criteria:

Neonates suffering from a lethal genetic or chromosomal abnormality or other non-infectious, life-limiting illness, known at the time parents would be approached for consent.
The Effect of Watching Informative Animation on Fear and Anxiety in Children

The aim of this project was to determine the effect of showing informative animations to children on anxiety and fear during inhalation therapy. This project is a randomized controlled trial. The population of the study will consist of children aged 7-12 years who apply to the Pediatric Emergency Department of Atatürk University Research Hospital between July 2022 and July 2023. The sample of the study will consist of children and their parents who present to the clinic on the dates determined, who are willing to participate in the study, and meet the inclusion criteria. Probability sampling will be used to select the sample. ''Introductory Information Form'', ''Child Fear Scale'', ''Facial Expression Rating Scale'' and ''Informative Animation'' will be used for data collection.

Type of Study: The study was designed as a randomized controlled experimental study. Place and Time of Research:

The study will be conducted at Atatürk University Research Hospital Pediatric Emergency Department between July 2022 and July 2023.

Population and Sample of the Study: The population of the study will consist of children aged 7-12 years who apply to the Pediatric Emergency Department of Atatürk University Research Hospital between July 2022 and July 2023.

Eligibility Criteria:
Inclusion Criteria:

* The child is 7-12 years of age
* The family's willingness to participate in the study
* The child's willingness to participate in the study
* The child does not have a chronic disease

Exclusion Criteria:

* The child has a chronic illness
* The child has a neurological or mental impairment
* The child is visually impaired
Comparing an Automated to a Conventional Sepsis Clinical Prediction Rule

The investigators will conduct a prospective cohort study to compare an automated sepsis severity score to a conventional clinical prediction rule to risk stratify patients admitted from the emergency department (ED) with suspected infection for 28 day in-hospital mortality.


Eligibility Criteria:
Inclusion Criteria:

* All consecutive adult (age 18 or older) Emergency Department (ED) patients during the study period that have been admitted from the ED and identified by the treating clinician to have a suspected infection at the time of ED disposition will comprise our study population.

Exclusion Criteria:

* No patients will be excluded from the study.
Vascularized Versus Non-Vascularized Bone Grafts in Treating Proximal Pole Scaphoid Non Unions

The purpose of this study is to investigate whether treatment of scaphoid non-unions with a vascularized bone grafts improves patient reported pain and disability compared to treatment with a non-vascularized bone graft. Secondary objectives are to examine if there is any difference in the overall rate and time to union, range of motion, grip strength, or complication rates between the two groups.

In addition, this is the first prospective randomized study to directly compare the two techniques. This is also the first study to use standardized methods of assessing union (based on computerized tomography), standardized methods of collecting objective patient data, and utilizing validated patient questionnaires to assess pain and disability.


Eligibility Criteria:
Inclusion Criteria:

* The primary inclusion criterion is any scaphoid waist or proximal pole non-union in a patient receiving a recommendation for operative treatment. Non-union is defined as \<10% bony union across the fracture site on sagittal computerized tomography (CT) after at least 16 weeks of appropriate non-operative treatment or morphologic features on plain x-ray and CT (resorption and sclerosis at the fracture site, significant cyst formation) confirming non-union.

Exclusion Criteria:

* radiologic evidence of significant scaphoid non-union advanced collapse (SNAC) wrist arthritis
* fragmentation of the proximal pole
Masseter Muscle Thickness in Gasser Ganglion Radiofrequency Treatment

Trigeminal neuralgia is common painful disorder in pain medicine clinics. Gasserian ganglion radiofrequency thermocoagulation is one of the treatment option in patients with trigeminal neuralgia in refractory cases. The most commonly involved branch in trigeminal neuralgia is the mandibular branch. Masseter muscle is innervated by mandibulary nerve branch of the trigeminal nerve.

The radiofrequency thermocoagulation therapy is used to ablate the affected trigeminal nerve branch and some of patients complain of subjective masseter weakness after this procedure.

In theoretical basis, muscles innervated by target nerve are affected from ablation procedure. In this study the primary aim is to evaluate the change of the masseter muscle thickness in patients treated by gasserian ganglion radiofrequency thermocoagulation. The results may also show possible functional effect of the procedure related with masseter muscle.


Eligibility Criteria:
Inclusion Criteria:

* Pain refractory to medical therapy for at least 3 months
* Planning radiofrequency thermocoagulation of gasserian ganglion
* Accept ultrasound measurements to be performed

Exclusion Criteria:

* Refused to participate in the study
* Not attending follow-ups regularly
* Coagulation disorder
* Pregnancy
* Localized or systemic infection
Eat-Lancet Index and Sustainable Eating Across Professions

This study aims to evaluate the relationship between the EAT-Lancet Index of occupational groups and sustainable nutrition behaviors. The study included 2,705 individuals aged 19-65 working in various occupations, using dietary assessment tools and the ehaviors Scale Towards Sustainable Nutrition (BSSN), and were analyzed with SPSS 24.

The study included 2,705 individuals aged 19-65 working in various occupations. Data were collected using a demographic structure survey and the Behaviors Scale Towards Sustainable Nutrition (BSSN). A food consumption frequency survey was administered to calculate the EAT-Lancet Index. Occupations were classified into five groups according to the International Standard Classification of Occupations (ISCO)-88: Groups 1-2, 3-4, 5-8, 6-7, and 9-10. Additionally, occupational skill levels were categorized into four levels (1 being the lowest and 4 the highest) based on ISCO-88. Statistical analysis was performed using SPSS version 24.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 19 to 65 years

Exclusion Criteria:

* Unemployed and retired individuals
* Individuals with alcohol or drug addiction
* Individuals diagnosed with psychiatric or neurological diseases
* Illiterate individuals.
Budapest Upgrade CRT Study (Version 009-4.1)

Effect of biventricular upgrade on left ventricular reverse remodeling and clinical outcomes in patient in left ventricular dysfunction and intermittent or permanent apical/septal right ventricular pacing (Budapest CRT upgrade study)

The aim of this study is to investigate the effect of upgrade to a CRT-D device on clinical and echocardiographic response at 12-month in patients with left ventricular dysfunction (LVEF ≤35%), symptomatic heart failure (NYHA II, III, IV-a), and intermittent or permanent right ventricular pacing with paced QRS complex ≥ 150 ms compared to continued therapy with a single or dual chamber pacemaker (PM) or ICD.

Prospective, post-market, international multicenter randomized controlled trial.

Eligibility Criteria:
Inclusion Criteria:

* Male or female patients over the age of 18 (expected survival time: over 1 year)
* Patients with ischemic or non-ischemic cardiomyopathy;
* Those implanted with a single or dual chamber ICD or implanted with a single or dual chamber pacemaker at least 6 months before inclusion;
* Elective generator replacement or upgrade from pacemaker-only to ICD therapy may be indicated at the time of enrollment, but are not required;
* Right ventricular pacing 20-100% in at least the last 90 days before enrollment (with an optimal AV interval based on the physician's discretion to avoid unnecessary right ventricular stimulation);
* Symptomatic heart failure for at least 3 months before inclusion;
* NYHA functional class II or III, or IV a;
* Left ventricular ejection fraction measured by echocardiography ≤ 35%;
* Paced QRS complex ≥ 150 ms;
* Optimal heart failure medical therapy;
* Informed consent obtained.

Exclusion Criteria:

* Intrinsic QRS with LBBB morphology (measured at VVI 40 bpm setting as per protocol);
* CABG or PCI in the past 3 months;
* Acute myocardial infarction in the past 3 months;
* Unstable angina;
* Planned coronary revascularization (PCI or CABG);
* Planned cardiac transplantation;
* Acute myocarditis;
* Infiltrative myocardial disease;
* Hypertrophic cardiomyopathy;
* Severe primary mitral and aortic valve stenosis or regurgitation;
* Women who are pregnant or plan to become pregnant or breastfeeding;
* Subjects who are unable or unwilling to cooperate with the study protocol;
* Tricuspid valve prosthesis;
* Any serious disease likely to interfere with the conduct of the study;
* Participation in other clinical trial;
* Patients geographically not stable or unavailable for follow-up;
* Chronic, severe renal dysfunction (creatinine value \> 200 μmol/l);
* Severe RV dilatation (RV basal diameter \>50mm);
* Severe tricuspid insufficiency.
Dermal Thermometry and Self-Care of High Risk Diabetic Patients

Foot ulcers remain the most common reason for hospital admission among veterans with diabetes. Healing and preventing these wounds should be a high priority for clinicians treating these high-risk patients. Previous work by the investigators has suggested that diabetic foot ulcers are preceded by inflammation, which can potentially be detected with a thermometer.

Background:

Foot ulcers remain the most common reason for hospital admission among veterans with diabetes. Healing and preventing these wounds should be a high priority for clinicians treating these high-risk patients. Previous work by the investigators has suggested that diabetic foot ulcers are preceded by inflammation, which can potentially be detected with a thermometer.

Objectives:

The purpose of this project is to evaluate the utility of a novel personal dermal thermometry system to empower patients and caregivers and thereby reduce the risk for lower extremity ulceration and amputation in veterans at high risk for these complications.

Methods:

In this randomized clinical trial, 384 patients are being enrolled and assigned to either standard of care (SC) or SC plus a personal dermal thermometer (DT) to evaluate and log their plantar skin temperatures. All patients are given access to a 24 hour "hot foot line" to call for immediate access to care if they identify a hot spot (DT group) or a site of concern on standard self-evaluation (SC). All patients are assigned a sophisticated computerized activity monitor, which allows investigators access to time and magnitude of activity, downloaded at regular patient visits.

Status:

Project work is complete

Eligibility Criteria:
Inclusion Criteria:

vibration perception threshold needs to be greater than 25, palpable pulse, Over 18 years of age Has Diabetes and Neuropathy

Exclusion Criteria:

No ulcers. Unable to walk without assistance of wheelchair or crutches
Benefits of Online Mahjong by Older Adults

This study aims to examine the clinical efficacy of online Mahjong in improving physical health, cognitive performance, happiness, laboratory biomarkers, and structural brain imaging (magnetic resonance imaging, MRI) by a randomized controlled trial design, and hopefully to expand the scope of healthy aging intervention activities with strong scientific evidence.

Psychomotor function among older adult's decline was associated with reducing people interaction during pandemic has been reported. The research focused on examining the benefit and efficacy of digital based Mahjong games with 6-month intervention is very limited or none. A random control design was conducted with comparing intervention group and with control group, followed the CONSORT guidelines. Six months program was intervened to ensure the impact of the intervention. Primary outcome is brain imagery changes between groups, which showed changes in temporal fusiform cortex but not in resting-state fMRI. The total score of MoCA, delayed recall was increase from baseline to after intervention in experimental group. Overall cognitive function and visuospatial/executive, in experimental group improved more than control group. Improving self-rating daily health status as associated with achievement rate of Mahjong game. Increasing level of resilience was associated with demoralization level, subtraction of cognitive function, and 5th month walking steps. In addition, affecting incased self -rate overall heath was related to demoralization. In short, online mahjong intervention has positive impact on older adults in cognitive function , resilience, demoralization and overall quality of life.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 55 years old.
2. More than 6 years of formal education.
3. Can communicate in Mandarin and Taiwanese.
4. Can accept MRI examination without claustrophobia.
5. Can understand the research process, meet the requirements of the research, and can sign the consent form and participate in the subject.

Exclusion Criteria:

1. Have engaged in any Mahjong games in the past three months.
2. Engaged in Mahjong games more than three times per year in the past three years.
High-cutoff Hemodialyzer to Reduce Chronic Inflammation in Hemodialysis Patients

The purpose of this study is to test whether a dialyzer with a higher than usual permeability for proteins can eliminate proinflammatory proteins from the blood of patients on regular maintenance hemodialysis who have chronically elevated levels of inflammation markers such as C-reactive protein (CRP) in their blood.

Patients with ESRD on chronic hemodialysis patients frequently have elevated markers of inflammation (e.g. serum CRP values). Hemodialysis may clear the blood from low molecular weight toxins and retention products such as creatinine, potassium, or urea. The dialyzer clearance of middle to high molecular weight substances such as cytokines and cytokine receptors is low. Nearly 50% of chronic dialysis patients have persistent subclinical inflammation which is strongly associated with cardiovascular disease and mortality. The study tests the hypothesis that removal of proteins in the weight range of 10.000-30.000 D via a more permeable dialyzer membrane reduces chronic inflammation in these patients.

Eligibility Criteria:
Inclusion Criteria:

* regular hemodialysis for at least 3 months
* treatment thrice weekly
* high-flux hemodialyzer for at least 4 weeks
* age \> 18 years and \< 80 years
* at least one CRP value \> 5mg/L within 8 weeks before inclusion
* able to understand and consent the study
* written informed consent

Exclusion Criteria:

* no consent
* clinically apparent acute infection
* CRP \> 50 mg/L
* serum albumin \< 3,5 mg/L
* central venous line as dialysis access
* immunosuppressive medication
* pregnancy or lactation
* inclusion into any other interventional trial
A Randomized, Double-Blind, Parallel-Arm, Placebo and Active Controlled Dose-Ranging Study of the Efficacy and Safety of Multiple Doses of Tapentadol IR for Postoperative Pain Following Bunionectomy Surgery

This study was to evaluate the efficacy and safety of dosing regimens of tapentadol HCl immediate release capsules for the treatment of postoperative pain over a period of 12 hours on the first day following a bunionectomy in men and women.

Tapentadol hydrochloride is a centrally active analgesic (antinociceptive) compound. This was a multicenter, randomized, double-blind, parallel-group, placebo- and active-controlled dose study in men and nonpregnant, nonlactating women. The patients were at least 18 and no more than 75 years of age and experienced moderate to severe pain within 9 hours after removal of postoperative analgesia. The surgery was a standardized first metatarsal bunionectomy. Treatment of postsurgical pain after the 9 hr period was with either placebo, tapentadol, or oxycodone using various dosing regimens. The primary objective of this study was to evaluate the efficacy and safety of these treatments on total pain relief and total change in pain intensity over 12 hours and reporting of adverse events, laboratory values, vital signs, and ECGs. Secondary objectives included evaluation of several other pain measures, and drug pharmacokinetics and pharmacodynamics. Six patient treatment groups received study medication orally at 0, 4, and 8 hours with one of the following dosing regimens: 1) placebo, placebo, and placebo, 2) 93 mg, 93 mg, and 93 mg tapentadol IR, 3) 140 mg, 140 mg, and 140 mg tapentadol IR, 4) 140 mg, 70 mg, and 70 mg tapentadol IR, 5) 186 mg, 93 mg, and 93 mg tapentadol IR, and 6) 10 mg, 10 mg, and 10 mg oxycodone IR.

Eligibility Criteria:
Inclusion Criteria:

* Moderate to severe pain intensity within 9 hours of the discontinuation of the popliteal block, and permitted supplemental systemic analgesics, if taken, during the postoperative surgical period
* Moderate to severe categorical pain intensity and a pain intensity VAS = 40 mm

Exclusion Criteria:

* Randomization less than 10 hours after initiation of the standardized first metatarsal bunionectomy
* History of seizure (including febrile seizure), or loss of consciousness due to head trauma
* Use of antiparkinsonian drugs, neuroleptics, anticonvulsants, monoamine oxidase inhibitors (MAOIs), tricyclic antidepressants (TCAs), SSRIs, and SNRIs at any time within 30 days of surgery and throughout the study period
Evaluation of Neurological Status and School Readiness in Preterm Preschoolers

Beginning school is an important milestone for children. Children's readiness for school involves cognitive, physical, and emotional development. While the majority of children born preterm are able to transition from preschool to kindergarten with little difficulty, some children experience challenges during this time. Factors that negatively influence children's success in kindergarten include their age, socioeconomic status, neurological status and their ability to interpret sensory information from their environment.

This study was planned to explain the relationship between the primary school readiness and the neurological status of preterm born children.

A convenience of preterm and term preschoolers recruiting from Gazi University, Faculty of Health Science, Department of Physiotherapy and Rehabilitation. Each group contains 30 children. First, sociodemographic information and histories of children are obtaining. Ages and contact information of the parents are recording. Prenatal and natal risk factors of the mothers are querying. Gestational ages and height, weight, and head circumferences of babies at birth are recording. Number of pregnancies, live births and abortions, type of delivery, multiple pregnancies for mothers as well as consanguinity between parents are asking. Marmara Primary School Readiness Scale is using to evaluate mental-language development, socio-emotional development, physical development, self-care skills,math skills, science skills, voice exercises, line exercises and labyrinths. Sensory profile caregiver questionnaire screen for the senses (sensory processing), adjustment (modulation), behavioral and emotional responses. The Touwen examination (neurological examination) is using to evaluate posture in various positions, muscle tone, dyskinesias, range of motion, reflexes, sensory function and cranial nerve function as well as developmental items, i.e. the items dealing with coordination, fine manipulative abilities and associated movements. All examination wiil be finished in the same day.

Eligibility Criteria:
Inclusion Criteria:

* No neurological diagnosis
* gestational age \< 37 weeks
* 60-78 months of age

Exclusion Criteria:

* Have a neurological diagnosis (such as cerebral palsy)
* Grade III or grade IV intraventricular hemorrhage
* Have undergone major surgery in neonatal period
* Mental retardation