cyrilzakka/clinical-trials huggingface dataset:
Urinary Leukotriene E4 Levels in Children With Obstructive Sleep Apnea

Investigate urinary leukotriene E4 levels and determine if there is a correlation with severity of obstructive sleep apnea. The investigators then would like to determine a threshold level which could then be used for confirmation of diagnosis of obstructive sleep apnea (OSA).


Eligibility Criteria:
Inclusion Criteria:

* children 2-16 years of age
* scheduled for polysomnogram

Exclusion Criteria:

* cardiovascular, neuromuscular, immunologic or craniofacial disorders
* pharmacologic treatment including corticosteroids and leukotriene receptor antagonists in the last month
* subjects who have already received treatment for OSA with an oral appliance, continuous positive airway pressure (CPAP) device
* previously undergone tonsillectomy and/or adenoidectomy
PreCoCa - "Prehospital Cooling With Cool-Caps"

This study shall investigate the feasibility of the use of cool-caps in the preclinical setting in patients with successful primary cardio-pulmonary resuscitation Hypothesis: cool-caps are efficient and feasible to use in the preclinical setting in patients after successful CPR.


Eligibility Criteria:
Inclusion Criteria:

* All patients with primary successful CPR

Exclusion Criteria:

* Age \< 18
* Pregnancy
* Severe bleeding or severe trauma
* Body core temperature \< 34 degrees celsius
The Effect of Mobile Augmented Reality Application on Nursing Students' Knowledge Skills and Motivation

The aim of this study was to examine the effects of a mobile augmented reality application on nursing students' knowledge, skills, and motivation regarding pressure injuries.

The research is a randomized controlled, quasi-experimental study. The population of the study consisted of 130 first-year students enrolled at Gülhane Faculty of Nursing, University of Health Sciences. In the study, a mobile augmented reality application was used for the training of students in the intervention group regarding pressure injury prevention. The training of the control group students continued with traditional education methods. The data collection process of the study was carried out in two stages: preparation and implementation. Prior to the commencement of the study, ethical committee approval and institutional permissions were obtained. In the analysis of the data, descriptive statistical methods such as number, percentage, min-max values, median, mean, and standard deviation were used, along with independent t-test, dependent t-test, and Chi-square analysis.

Eligibility Criteria:
Inclusion Criteria:

* Volunteering to participate in the study.
* Taking the Fundamentals of Nursing course for the first time.

Exclusion Criteria:

* Using a language other than Turkish as a native language.
* Graduating from a Vocational Health High School.
* Being enrolled in the nursing faculty through vertical transfer.
* Working as a nurse or healthcare staff in a hospital or any healthcare institution.
* Being excluded from the control and experimental groups during randomization.
Effects of Stretching Types on Gastrocnemius

Stretching is the process of positioning certain muscles and related soft tissues of the body in a position that will lengthen them. In addition to increasing the range of motion of stretching, different stretching on many functional (maximum isometric torque, muscle-tendon stiffness, passive-resistive torque, viscoelastic deformation) or structural parameters (muscle stiffness, tendon stiffness, muscle fascicle length, pennation angle, neuromuscular relaxation) We can make changes using methods.

Static stretching usually involves actively or passively moving a limb to the full range of motion, holding this stretched position for 15-60 seconds, and then repeating it 2-4 times. Dynamic stretching encompasses all body movements and involves actively moving the active joints through the range of motion in a controlled manner. PNF stretching is known to be more effective than other stretching techniques as it increases both passive and active flexibility and improves joint range of motion in the short term.

The appropriate evaluation of muscle characteristics and keeping a regular record are very important for the course of rehabilitation, clinical decisions, the creation of an appropriate treatment plan, and the evaluation of treatment practices. Objective evaluation methods are needed to measure the functional state of the muscles, that is, their viscoelastic properties. Myotonometric measurement, which is a painless, objective, and non-invasive measurement method, allows the measurement of muscle tone, elasticity, and stiffness. The myotonometer device is a portable handheld device used to measure the stiffness of soft tissues, including muscles and tendons, using a non-invasive approach. It is a device that is easy to use, fast, and very suitable for the purpose. Based on this information, the aim of our study is to evaluate the effects of different stretching types on gastrocnemius muscle viscoelastic properties and performance.


Eligibility Criteria:
Inclusion Criteria:

* Be between the ages of 18-45
* Volunteer to participate in the study

Exclusion Criteria:

* Those who have had major surgery or trauma related to the musculoskeletal system, especially the ankle and calf region
* Those with neurological disease
* Those with rheumatic disease in the active period
* Those with systemic diseases (Diabetes, hypothyroidism, infection, malignancy...)
* Those with serious psychological problems (BDI score of 30 and above)
* Those with contraindications to stretching (acute inflammations, viral and bacterial infections, infectious diseases, fever, deep vein thrombosis, active malignant disease, aneurysms)
* Those who received physiotherapeutic intervention in the ankle and calf region in the last 6 months
* Obesity (BMI≥30 kg/m2)
Percutaneous Endoscopic Lumbar Discectomy Add by Annuloplasty and Nucleoplasty

Recently, percutaneous endoscopic lumbar discectomy (PELD) is also commonly performed for lumbar disc herniation. Following discectomy, the relief of leg pain is common; however, the relief of back pain is less predictable. The association of back pain and lumbar disc herniation is still unclear. PELD and Annuloplasty (PELDA) can relieve back pain associated with disc herniation as well as leg pain through decompression and thermal ablation of annular defects in selected patients. Another problem that rapidly increasing go along with the growing number of microdiscectomies is directly proportional to the number of patients who undergo re-operations due to recurrences. The surgical treatment can be helpful in prevention of re-operations is nucleoplasty. Endoscopic discectomy for lumbosacral herniation supplemented with nucleoplasty can reduce the recurrence and reoperation rates.


Eligibility Criteria:
Inclusion Criteria:

* Primary single-level lumbosacral intervertebral disc herniation at the L4-L5 or L5- S1 level will perform surgical intervention of percutaneous endoscopic lumbar discectomy
* All patients present with sciatica and back pain that will not improve with conservative treatment for a minimum of 6 weeks
* All patients undergo plain radiographs, magnetic resonance imaging (MRI)
* The patients will require to have an obvious disc herniation that caused compression of a nerve root corresponding to the dermatomal distribution of the leg symptoms.

Exclusion Criteria:

* Patients have foraminal, extra-disc herniation, multilevel disc herniation, spinal stenosis, spondylolisthesis, scoliosis, prior lumbar surgery, spinal infection, spinal tumor, and a history of hip or knee arthritis.
Short Term Group Therapy for Anxiety Disorder

Assessing Anxiety in patient suffering from anxiety disorders (NOT OCD or PTSD)before and after group therapy


Eligibility Criteria:
Inclusion Criteria:

* Anxiety disorder (other than OCD or PTSD)
* Eligibility to participate in group therapy

Exclusion Criteria:

* OCD
* PTSD
* Suicidal thoughts
* Psychotic state
* Severe hostile personality disorder
Development of a Genetic Counseling Patient Preference Intervention for Women at Elevated Risk for Breast Cancer

This study develops a genetic counseling patient preference intervention for women at elevated risk for breast cancer. This study aims to develop an intervention that may deliver educational videos about breast cancer, heredity, multigene tests results and polygenic risk score, provide multigene and polygenic test results, obtain information about patients' questions/ concerns about test results to use in post-genetic test counseling, and determine patient preference (e.g. telephone) for receipt of post-genetic test counseling.

PRIMARY OBJECTIVE:

I. Develop the Genetic Counseling Patient Preference (GCPP) intervention in collaboration with community members.

OUTLINE:

Participants attend a focus group over 90-120 minutes providing feedback on GCPP intervention.

Eligibility Criteria:
Inclusion Criteria:

* Female
* Ages 35-64
* Known elevated risk for breast cancer
* The ability to speak and read English
* Provide written consent
Predictors of Therapeutic Success and Adverse Events in Endoscopic Ampullectomy

Although ampullary tumors are rare (representing 0.6-0.8 % of all digestive cancers), their estimated incidence has increased in recent years (\<1 per 100 000 per year). Most noninvasive ampullary tumors of the major papilla occur as sporadic and asymptomatic lesions, detected during conventional upper endoscopy performed for another indication.

Nonetheless, they can present with jaundice (17%), pain (14%), pancreatitis (4%), cholangitis (1%), and can be associated with common bile duct stones (up to 38%). Resection of ampullary adenomas is warranted to prevent malignant progression. The most recent European Society of Gastrointestinal Endoscopy (ESGE) recommend endoscopic ampullectomy as the standard of care approach for ampullary adenomas without intraductal extension, due to excellent outcomes of technical and clinical success (high complete and curative resection rates of 94% and 87%, respectively), with lower morbidity and recurrence rates. This procedure as a low rate of mortality (of 0.4%), but the rate of adverse events can exceed 20%. The most frequent adverse events are acute pancreatitis (12%), intraprocedural and/or delayed bleeding (11%), perforation (3%), cholangitis (3%), ampullary stenosis (2.5%). Also there is a high recurrence rate of up to one third after endoscopic resection; up to two thirds are identified at the first follow-up endoscopy, requiring additional endoscopic resection or surgery.

The relevance of the study is to assess the predictors for therapeutic success, adverse events and recurrence after endoscopic ampullectomy is of paramount importance to develop expertise in this challenging procedure.

The occurrence of adverse events after endoscopic ampullectomy carries a significant impact on the prognosis and recovery, possibly limiting a broader proficiency in this procedure. Thus, identifying significant predictors is crucial to more accurately select the patients and to evolve strategies to prevent and minimize the incidence and severity of adverse events.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (≥18 years) submitted to endoscopic resection of an ampullary adenoma with the following features were included:

  * lesions up to 30 mm (including with laterally spreading component)
  * with low-grade or high-grade dysplasia on preprocedural histology
  * with no intraductal extension
  * with no evidence of invasive malignancy on endoscopic assessment (including endoscopic features including hard consistency, friable or ulcera:ve surface and spontaneous bleeding)
* A minimum follow-up period of one year afer endoscopic ampullary resection.

Exclusion Criteria:

* Patients with lesions with the following features were excluded:

  * intraductal extension
  * evidence of invasive malignancy
  * other non-adenomatous lesions
* Patients who underwent endoscopic resection or surgical ampullectomy prior to enrollment
* Patients with a follow-up of less than a year after endoscopic ampullary resection
* Patients with pancreas divisum.
Real-time Neurofeedback Training of the Medial Prefrontal Cortex Based on Positive Episodic Future Thinking

Randomized active-sham controlled between-subject real-time fMRI neurofeedback trial aiming to modulate activity in the medial prefrontal cortex (mPFC) to improve subjective positive anticipation.

A randomized double-blind sham-controlled between-subject design using real-time fMRI neurofeedback. In a randomized order, a total of 60 healthy subjects will be recruited and assigned (1) experimental group (EG; N=30), which receives real neurofeedback from the left medial prefrontal cortex (mPFC), or (2) control group (CG; N=30) which receives sham neurofeedback from the primary motor cortex (M1). Neurofeedback training consists of 1 baseline session without feedback, 4 training sessions with real-time feedback, and and 1 transfer session without feedback. Resting state fMRI will be employed to explore neural effects. Objectives are to determine (1) if subjects in the neurofeedback (NF) group can gain volitional control over the mPFC activation using positive episodic regulation strategy, (2) whether successful increased modulation of the mPFC could enhance positive anticipation for future events and motivation (using the Effort-Expenditure for Reward Task, EEfRT).

Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects without any past or present psychiatric or neurological disorders

Exclusion Criteria:

* History of brain injury
* Psychiatric or Neurological Disorder
* Contraindications for MRI
* Regular use of psychotropic substances (medication, drugs)
Is Respiratory Muscle Strength, Peripheral Muscle Strength and Postural Control Affected in Scoliosis?

The vertebral column is a structure that transfers the weight of the head and torso to the lower extremity, provides trunk movements and protects the spinal cord.A three dimensional deformity involving lateral flexion of the vertebrae in the frontal plane at 10 ° and above, including axial rotation and physiologic flexion (hypokyphosis) components in the sagittal plane, is defined as scoliosis. Adolescent idiopathic scoliosis (AIS) is a type of idiopathic scoliosis that occurs in the period from the onset of puberty (up to 10 years) until the closure of growth plates.

Scoliosis is caused by postural, balance and neuromotor disorders as a primary cause of impaired sensory integrity, proprioceptive feedback deficits, secondary lung problems, organ disorders and pain. Children with adolescent idiopathic scoliosis have inadequate respiratory function. At the same time, these children show muscle weakness in certain parts of the body.

The aim of this study is to compare young adolescents with scoliosis with their healthy peers and examine whether respiratory muscle strength, peripheral muscle strength and postural control are affected.


Eligibility Criteria:
Inclusion Criteria:

* Individuals agreeing to participate in the study
* In the age range of 10-20
* Patients with scoliosis with a Cobb angle of 15-40 degrees measured on X-Ray

Exclusion Criteria:

* Surgical operation in the last 3 months
* Having mental, communicative and behavioral disorders that may cause problems understanding commands and questions or performing exercises.
Effects of an Interdisciplinary Fitness and Social Engagement Intervention

This study will evaluate feasibility and preliminary effectiveness of a 10-week interdisciplinary and multimodal intervention that utilizes patient education, group discussion, and supervised exercise for Veterans with a history of traumatic brain injury (TBI). Primary outcomes include physical activity (PA), sleep quality, and community integration.

This randomized controlled trial will have a sample size of 24. Veterans between the ages of 18 and 65 in the Polytrauma and TBI program who are greater than 1 year post injury prior to entering the study, will be recruited. After randomization participants in the intervention group will complete a 10 week bout of multidisciplinary wellness education, group discussion, and supervised exercise. The intervention will occur weekly and last up to 2 hours. The control group will complete a 10week comprehensive health education program simultaneously. All measures will be collected again, post intervention. A follow-up collection will occur at 3 months post-intervention.

Eligibility Criteria:
Inclusion Criteria:

* TBI of at least mild severity using criteria related to disturbance of consciousness
* Most recent TBI occurred \>1 year prior to consent process
* Medically stable with physician approval to participate

Exclusion Criteria:

* Unable to provide informed consent and no proxy available
* Prior history of known bipolar disorder or schizophrenia or severe psychiatric illness
* Veterans with any cardiac condition that may cause sudden decompensation during cardiovascular testing and training (e.g., severe congestive heart failure and uncontrolled hypertension)
* Veteran is currently active in a skilled physical therapy program.
* Veterans who meet or exceed American Heart Association and American College of Sports Medicine guidelines for physical activity
The Effect of Intravenous Dexamethasone on Rebound Pain After Interscalene Brachial Plexus Block for Shoulder Surgery

The rebound pain after nerve block could interfere with the patient's recovery and rehabilitation. It is not known how intravenous dexamethasone affects rebound pain. This study aims to evaluate the effect of intravenous dexamethasone on rebound pain after interscalene block for shoulder surgery.

Shoulder rotator cuff repair and acromioplasty are associated with severe postoperative pain. The interscalene block (ISB) is commonly used for this type of surgery, providing analgesia by anesthetizing the nerves that supply the shoulder. Although the nerve block provides extremely effective analgesia for the first 6-8 hours, patients experience severe pain once its effect has been wearing off. Rebound pain is a severe pain that occurs when the effect of a nerve block disappears in a patient during the postoperative period. The purpose of this study is to investigate whether the use of intravenous dexamethasone reduces rebound pain in patients recruiting for shoulder surgery with interscalene brachial plexus blockade.

This study will be conducted as a single-center, prospective, randomized, double-blinded trial in a university hospital. Patients scheduled for elective shoulder surgery will be screened for enrollment in the study. All subjects will undergo ultrasound-guided interscalene nerve block before induction of general anesthesia. They will be randomly assigned into the two groups which use intravenous dexamethasone or not. An anesthesiologist who will perform blocks will not involve in the data collection. Other health care workers who will involve in the evaluation of postoperative pain scores, nausea and vomiting, opioid consumption, quality of Sleep, and Quality of Recovery score will be blinded to the group assignment.

Eligibility Criteria:
Inclusion Criteria:

* Undergoing shoulder surgery
* Having signed a written informed consent form,
* ASAI-III

Exclusion Criteria:

* Inadequate indication for interscalene block (Coagulation disorder, local infection of block site, Diaphragmatic paralysis, Allergy to local anesthetics)
* Neuropathic disorder
* Severe cardiopulmonary disease
* Systemic steroid use
* Chronic opioids use
* Stomach ulcer
* Ucontrolled Diabetes
* Psychiatric disorders,
* Pregnancy,
* Severe obesity (body mass index \> 35 kg/m2)
Dose Ranging Study for Indacaterol in Japanese Asthma Patients

This study was designed to provide data about the safety and efficacy of 3 doses of indacaterol (150, 300, and 600 µg) in Japanese asthma patients so that an optimal dose, or doses, could be chosen for testing in later studies.


Eligibility Criteria:
Inclusion Criteria:

* Male and female Japanese asthmatic patients aged 18 to 75 years old.

Exclusion Criteria:

* Patients who have been hospitalized or had emergency room treatment for an acute asthma attack in the 6 months prior to the first day of screening or during the screening period.
* Patients who have used tobacco products within 6 months prior to the first day of screening or have a smoking history of greater than 10 pack years.
* Patients with a history of malignancy with the exception of localized basal cell carcinoma of the skin.
* Pregnant or nursing (lactating) women.
* Patients who have had treatment with disallowed medications including investigational drug.

Other protocol-defined inclusion/exclusion criteria applied to the study.
SGLT2 Inhibitor or Metformin As Standard Treatment of Early Stage Type 2 Diabetes

A real-world, nationwide, register-based, randomised trial (RRCT) comparing SGLT2 inhibitors with metformin as standard treatment in early typ 2 diabetes. An open-label trial addressing efficacy with respect to clinically important macro- and microvascular events.

2067 type 2 diabetes (T2D) patients on monotherapy or drug naive. Randomization 1:1, metformin, dosing according to treatment guidelines or SGLT2 inhibitor, dapagliflozin 10 mg od.

844 events estimated for study completion (90% power to detect hazard ratio (HR) \<0.8 for dapagliflozin vs metformin ) Endpoint collection during study duration (about 4 years) from national health care registers: Patient, Prescribed drugs, Cause of death and Population registers; National diabetes register (NDR) Primary analysis according to insulin tolerance test (ITT)

Eligibility Criteria:
Inclusion Criteria:

* Men and women ≥18 years old
* T2D (according to World Health Organization (WHO) criteria) of less than 4 years duration
* BMI 18.5-45 kg/m2
* Drug naïve or oral monotherapy with glucose-lowering drug.
* Accepting NDR participation and other register data collection.

Exclusion Criteria:

* Known or suspected other form of diabetes than type 2
* Ongoing or more than \>4 weeks in total of any previous treatment with: insulin, GLP-1 receptor agonists, SGLT2 inhibitors or combination of any diabetes medications
* Medical need to start or intensify any specific GLD treatment, e.g. insulin due to marked hyperglycemia
* HbA1c \>70 mmol/mol for patients on monotherapy, \>80 in drug naïve
* Contraindication to either metformin or dapagliflozin, or any unacceptable risk with either treatment as assessed by the investigator
* History or signs of established cardiovascular disease: diagnosis of myocardial infarction, angina pectoris, heart failure, stroke, lower extremity arterial disease, any limb amputation (except due to trauma or malignancy)
* Any serious illness or other condition with short life expectancy (\<4 yr)
* Renal impairment (eGFR \<60 ml/min/1,73m2)
* Any condition, as judged by the investigator, that suggests that the patient will be non-compliant or otherwise unsuitable to study medication or study participation
* Pregnancy or breastfeeding, women of childbearing potential (WOCBP; including perimenopausal women who have had a menstrual period within 1 year) without adequate anticonception during any part of the study period
* Involvement in the planning and/or conduct of the study
* Ongoing participation in another clinical trial.