cyrilzakka/clinical-trials huggingface dataset:
NAVISTAR® THERMOCOOL® Catheter Post Approval Registry

The purpose of this registry is to provide additional corroborative short-term safety and long-term safety data for the NAVISTAR THERMOCOOL and NAVISTAR EZ STEER THERMOCOOL catheters in the treatment of symptomatic Paroxysmal Atrial Fibrillation (PAF).

This registry is a prospective, multi-center, non-randomized post approval evaluation comprised of two (2) registry arms with independent hypotheses. The registry arms are defined as; Arm 1) physicians who perform greater than or equal to 50 atrial fibrillation ablation procedures per year and Arm 2) physicians who perform less than 50 atrial fibrillation ablation procedures per year. Subjects with drug refractory recurrent symptomatic PAF will be considered for this post approval registry. This registry will be conducted at up to 40 centers in a minimum of 381 evaluable subjects. The devices are currently FDA approved for commercial distribution under PMA #P030031/S11.

Eligibility Criteria:
Inclusion Criteria:

Candidates for this registry must meet ALL of the following criteria:

* Patients with drug refractory recurrent symptomatic PAF who have had three (3) AF episodes in the six (6) months prior to enrollment and one AF episode documented within the one (1) year prior to enrollment. Documentation may include electrocardiogram (ECG), transtelephonic monitor (TTM), Holter monitor (HM), or telemetry strip.
* Failure of at least one AAD for AF (class I or III or AV nodal blocking agent such as beta blockers and calcium channel blockers) as evidenced by recurrent symptomatic PAF, or intolerable side effects.
* Age 18 years or older.
* Able and willing to comply with all pre-, post- and follow-up testing and requirements.
* Signed Patient Informed Consent Form.

Exclusion Criteria:

Candidates will be excluded from the registry if any of the following conditions apply:

* Atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause.
* AF episodes that last longer than 30 days and are terminated via cardioversion.
* CABG procedure within the last six (6) months.
* Awaiting cardiac transplantation or other cardiac surgery.
* Documented left atrial thrombus on imaging (i.e., TEE, ICE, CT, or MRA).
* History of a documented thromboembolic event within the past one (1) year.
* Diagnosed atrial myxoma.
* Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this registry.
* Women who are pregnant (by history of menstrual period or pregnancy test if the history is considered unreliable).
* Acute illness or active systemic infection or sepsis.
* Unstable angina.
* Uncontrolled heart failure.
* Myocardial infarction within the previous two (2) months.
* History of blood clotting or bleeding abnormalities.
* Contraindication to anticoagulation (i.e. heparin or warfarin).
* Life expectancy less than 12 months.
* Enrollment in an investigational study evaluating another device or drug.
* Presence of intramural thrombus, tumor or other abnormality that precludes catheter introduction or manipulation.
Telerehabilitation in Lung Surgery Patients

In this study, providing access to physiotherapy applications by telerehabilitation method and the effectiveness of this application will be examined for patients who have undergone lung surgery in the early postoperative period during the pandemic process in which social isolation continues.

* Patients who meet the inclusion criteria and agree to participate in the study will be included in the study.
* Patients diagnosed with lung cancer and underwent thoracotomy will be randomly divided into Telerehabilitation Group (TGR) and Control (KG) groups.
* Before the operation, enlightened and signed consent will be obtained from the cases, the first evaluations of the patients in both groups will be made and the first exercise training will be given to the telerehabilitation group.
* The study group will be followed up every day during their hospitalizations and the final tests of both groups will be made before discharge. Long-term follow-up will be carried out in the 1st month and 3rd month after discharge.

Eligibility Criteria:
Inclusion Criteria:

* Having a smart phone and capable of making video calls,
* Planned to be operated with thoracotomy or videothoracoscope,
* Staged between IA and IIIB with clinical staging,
* With proven lung tumor (If AC diagnosis is not confirmed after frozen or wedge, the patient will be excluded from the study),
* Patients with no cardiac disease (ASA II or better) that affects their quality of life.

Exclusion Criteria:

* Having a cardiac disease that affects the quality of life,
* Serious cognitive problems and presence of psychiatric diseases,
* Presence of physical limitations (vision, hearing impairment, orthopedic problems).
A Safety Comparison of Iopromide and Iodixanol in Renal Impaired Patients

The investigators intend to find out which contrast agent has less kidney toxicity in renal impaired patients undergoing cardiac angiography or percutaneous coronary intervention (PCI).

In the diagnosis and treatment of coronary heart disease, patients should undergo cardiac angiography or percutaneous coronary intervention (PCI). In those procedures, the investigators should use the contrast media, and it may cause kidney toxicity especially in the patients with chronic renal insufficiency.

Eligibility Criteria:
Inclusion Criteria:

* 18 years old or older
* Plan to undergo Cardiac Catheterization
* Signed ICF
* eGFR: 30\~59 mL/min/1.73m2

Exclusion Criteria:

* Pregnancy
* Under dialysis
* Conditions interfering with Cardiac Catheterization
* Participation in other trials
* Allergic to X-ray contrast media
* Administration of any investigational drug within the previous 30 days
* Intra-arterial or intravenous administration of iodinated contrast medium from 7 days before to 72 hours after the administration of study drug
* Left ventricular ejection fraction (LVEF) less than 30% by ultrasound examination
* Intake of any nephrotoxic medications 24 hours before or after the administration of study drug
Efficacy of Photobiomodulation on Wound Healing and Il-6 in Neuropathic Foot Ulcer

The aim of this study is to detect the effect of Laser Photobiomodualation on the wound healing and Il-6 in neuropathic foot ulcer.

Wound healing is a complex, interactive, and integrative event, involving cellular and chemotactic activity with release of chemical mediators associated with vascular responses and cell proliferation. It consists in a sequence of events leading to the closure of dermal injuries. The repair follows steps of inflammation, re-epithelization, wound contraction, and matrix remodeling. The healing process can be influenced by various local and systemic factors.

The ulcer treatment in the diabetic foot requires a multidisciplinary approach, including revascularization and surgical procedures, as well as the infection treatment, physiotherapeutic rehabilitation with electric phototherapeutic resources to control edema, pain, metabolic disorders, tissue malnutrition, co morbidities, precise treatment of the wound and biomechanics' decompression that will help in amputation prevention.

Biophotomodulation in the form of Low level laser (LLL) irradiation can promote cell migration and cell proliferation by stimulating mitochondrial activity and maintaining viability without causing damage to the wounded cells.

The usage of LLLT presents itself as being a new therapeutic proposal, seeking the cure of these injuries, the improvement on the quality of life of the affected individuals, as well as the reduction of the costs of the treatment in the health system, this study aims to identify the effects of low-level laser therapy on neuropathic foot ulcer healing and the effect of LLL on the hyperglycemic-induced inflammatory response in IL-6 and sought to identify which pathway it might achieve this effect.

Eligibility Criteria:
Inclusion Criteria:

* All patient will be diagnosed with neuropathic foot ulcer.
* All patient diagnosed as type II Diabetes Mellitus.
* Wound size a 6-12 cm2.
* Diabetic ulcers will be in grade 2 and 3 (Partial thickness skin loss involving epidermis and or dermis (superficial, abrasion, blister, and / or full thickness skin loss damage ore necrosis of subcutaneous tissue may extend down to but not through underlying fascia.

Exclusion Criteria:

* Presence of osteomyelitis.
* Patients associated with critical illness who needs intensive care.
* Patients who suffer from cellulitis.
* Patients who suffer from nerve injury.
* Pregnancy.
* Smokers
* Malignant diseases
* Use of immunosuppressive drugs
* Phenytoin, cyclosporine, calcium channel blockers, etc.
* Patients who not have burn or ulcer or trauma in this area
Evaluating Hearing Aid Service Delivery Models

The purpose of this study is to compare the outcomes for two different hearing-aid delivery models. In one model, the audiologist selects and fits the hearing aid and, in the other model, the consumer does this directly.

The objectives of this study were to determine efficacy of hearing aids in older adults using audiology best practices, to evaluate the efficacy of an alternative over-the-counter (OTC) intervention, and to examine the influence of purchase price on outcomes for both service-delivery models. The design of this study was a single-site, prospective, double-blind placebo-controlled randomized trial with three parallel branches: (a) audiology best practices (AB), (b) consumer decides OTC model (CD), and (c) placebo devices (P). Outcome measures were obtained after a typical 6-week trial period with follow-up 4-week AB-based trial for those initially assigned to CD and P groups.

Older adults from the general community were recruited via newspaper and community flyers to participate at a university research clinic. Participants were adults, ages 55-79 years,with mild-to-moderate hearing loss. Intervention(s): All participants received the same highenddigital mini-behind-the-ear hearing aids fitted bilaterally.AB and P groups received best-practice services from audiologists; differing mainly in use of appropriate (AB) or placebo (P) hearing aid settings. CD participants self-selected their own pre-programmed hearing aids via an OTC model. Primary outcome measure was a 66-item self-report, Profile of Hearing Aid Performance/Benefit. Secondary outcome measure was the Connected Speech Test benefit.

Eligibility Criteria:
Inclusion Criteria: (for groups 1-4)

* 55-79 yrs of age
* Native English speaker
* no prior hearing aid use
* ability to read 18 point font

Exclusion Criteria: (for groups 1-3)

* hearing loss too severe or too mild for hearing aid
* middle-ear conductive pathology present
* asymmetrical hearing loss
* presence of dementia, Parkinson's disease, or other neurological disorder

Exclusion Criteria : (for groups 1-4)

- subject not interested in purchasing hearing aids
Effect of Face Masks on Pulmonary Function in Patients With COPD

Given the heightened vulnerability of COPD patients to severe illness upon SARS-CoV-2 infection, precautions like mask-wearing are deemed crucial. Yet, mask-wearing can exacerbate breathlessness and discomfort in this demographic. This study aims to assess the effects of wearing a face mask during 6-Minute-Walking-Tests (6-MWT) among COPD patients.

In this detailed study, we aim to explore the impact of wearing face masks on COPD patients during 6-Minute-Walking-Tests (6MWT). COPD, commonly observed among smokers and former smokers, poses heightened mortality risks upon SARS-CoV-2 infection. Consequently, face masks are often recommended for preventive measures. However, breathlessness remains a predominant symptom in this patient cohort. Moreover, there is a dearth of data concerning blood oxygenation levels while wearing various types of face masks.

The study will involve COPD patients who will undergo three 6MWTs: one without a mask, one with a simple face mask, and one with a FFP2 mask. Prior to each 6MWT, comprehensive pulmonary function tests including spirometry, body plethysmography, and CO-diffusion capacity measurement will be conducted. Additionally, capillary blood gas analysis will be performed both before the 6MWT and after each test session.

Eligibility Criteria:
Inclusion Criteria:

* COPD Diagnosis
* Vaccinated against SARS-CoV 2

Exclusion Criteria:

* Known cardial insufficency
* Long term oxgenation therapy
* immobility
* BMI \>35
* Pregnancy
Evaluating the Efficacy of a 91-day Self-talk Mental Health Self-care Journal

1. Does a 91-day self-talk journal intervention improve outcomes of self-criticism, self-esteem, automatic negative self-statements, and mental health among participants using the journal over wait-list control?
2. What is the adherence rate to a 91-day self-talk journal intervention?
3. What were participants' experience(s) of using a 91-day self-talk journal?

The following research project can contribute to the investigators' understanding of how/how well self-guided resources can increase participant outcomes of self-criticism, self-esteem, automatic negative self-statements, and mental health. Self-guided resources such as a self-talk journal provide can provide an easily accessible avenue for improving individual mental health. There has been a recent surge in the popularity of health-promotive self-care products, or products aimed at providing individuals with "the knowledge, skills, and attitudes required to achieve and maintain good health". These products (often in the form of journals) are similar to "self-help books"; however, a key difference is that self-care products prompt and provide space for the reader to actively engage in activities and psychological techniques, unlike the passive nature of traditional self-help books. These products typically address mental health concerns (i.e., mental health self-care) and are advertised to provide an effective means for individuals to reduce stress, improve self-compassion, and boost wellbeing. What's more, the generally positive reviews these products garner provides the perception that these products are well-received and effective in eliciting these outcomes. However, the scientific foundation for the majority of these journals is unknown. Furthermore, the efficacy of these products for improving or promoting their intended outcome(s) is often not addressed outside of these, often positive, reviews.

Eligibility Criteria:
Inclusion Criteria:

(1) being 19+ years old, (2) being fluent in English, (3) currently living in the Greater Victoria area, (4) self-reporting no previously diagnosed mental illness or psychiatric conditions, and (5) scoring \>12 on the Self-Criticism subscale of the Self-Talk Scale (based on previous mean data; Brinthaupt, Hein, \& Kramer, 2009).

Exclusion Criteria:

* Scoring =\<12 on the Self-Talk Scale, currently receiving or seeking therapy for a mental illness, or a current or previous diagnosis of mental illness.
Determination of Intratumoral Concentrations of Kinase Inhibitors in Patients With Advanced Solid Malignancies.

The purpose of this study is to determine intratumoral concentration of kinase inhibitors upon 2 weeks of treatment in tumor tissue of patients.

Patients will be cohort-wise treated with clinically available kinase inhibitors for 2 weeks prior to standard palliative treatment. Five patients will be included in each of eight drug cohorts. Biopsies will be performed to determine intratumoral drug concentrations and to compare tissue (phospho)proteomic and kinase activity profiles before and during therapy.

Eligibility Criteria:
Inclusion Criteria:

* Advanced solid malignancy
* minimum age 18 years
* indication for palliative treatment
* measurable disease with at least one lesion accessable for biopsy

Exclusion Criteria:

* Cardiovascular conditions including congestive heartfailure NYHA class \>2
* recent myocardial infarction or uncontrolled coronary artery disease
* cardiac arrhythmias requiring anti-arrhythmic therapy
* uncontrolled hypertension
* uncontrolled infections
* serious non-healing wound, ulcer or bone fracture
* pregnant or breast feeding
Evaluation of Cork Splint Materials Instead of Plaster Splint for Children

This is an evaluation of the functionality and added value of cork splint materials instead of a plaster splint for children (3-11 years old).


Eligibility Criteria:
Inclusion Criteria:

* Fractures of the wrist, forearm, elbow, ankle, foot
* Distortions of the wrist, elbow, ankle
* Wounds without tendon injuries
A Pharmacokinetic Study of TS-142 in Patients with Hepatic Impairment

This is an open-label pharmacokinetic study of TS-142 in patients with hepatic impairment


Eligibility Criteria:
Inclusion Criteria:

\<Inclusion criteria for patients with hepatic impairment\>

1. Japanese male and female who are aged 18 to 75 years at the time of informed consent
2. Patients with cirrhosis or chronic hepatic impairment
3. Patients classified as Child-Pugh classification A (mild) or B (moderate) by the principal investigator or sub-investigator at the screening test Other protocol defined inclusion criteria could apply.

\<Inclusion criteria for subject with normal hepatic function\>

1. Japanese male and female who are aged 18 to 75 years at the time of informed consent
2. Body Mass Index (BMI) between 18.5 and 35.0 at the screening test Other protocol defined inclusion criteria could apply.

Exclusion Criteria:

\<Exclusion criteria for patients with hepatic impairment\>

1. Patients who have a history of liver resection or liver transplant
2. Patients with hepatic encephalopathy of grade II or higher
3. Patients with epidermal growth factor receptor (eGFR) less than 45 mL/min/1.73 m2 at the screening test Other protocol defined exclusion criteria could apply.

\<Exclusion criteria for subjects with normal hepatic function\>

1. Subjects who are judged to have any disease by the principal investigator or sub-investigator
2. Subjects with eGFR less than 60 mL/min/1.73 m2 at the screening test Other protocol defined exclusion criteria could apply.
Study of Neuromuscular Electrical Stimulation to Increase Spontaneous Physical Activity in Obesity Patient

The study was designed to test the following hypotheses:

Main Objective:

To compare the level of spontaneous physical activity at 3 months after re-entrainment by multi-site electrical stimulation (m-ES), measured by actigraphy over 7 days, compared to conventional care (lifestyle and dietary advice and placebo (simulated) electrostimulation) (control arm).

Secondary Objectives:

To compare the metabolic, inflammatory, cardiovascular and functional parameters, physical activity, quality of life and quality of sleep, at 3 months and at 2 years in the two groups.

Design:

We will conduct a multicenter controlled study vs. reference care with randomization into two parallel groups and double-blind (placebo electrostimulation). Patients will have the ES material available at home and will be supervised by monthly visits over 3 months and by telephone follow-up for two years. The study size calculation is based on physical activity, the percentage of lean body mass and arterial stiffness measured in the OBEX study (NCT01155271).

This project will determine whether the training strategy is effective for increasing physical activity and/or in inducing significant metabolic and cardiovascular effects in these patients after 2 years. In addition, it provides a solid base of investigation for the study of the interactions between muscle contraction and cardio-metabolic health with greater precision.

Obesity and sleep apnea syndrome lead to metabolic troubles and increasing cardiovascular risk. Furthermore, both diseases are associated with reduced exercise tolerance.

For many patients with morbid obesity, the implementation of physical activity programs remains difficult for several reasons including the level of disability and psychosocial causes (the scrutiny of others, depression and poorly adapted equipment).

Main hypothesis: Neuromuscular electrostimulation is a way to increase spontaneous physical activity (PA) in treated apneic obese patients with low spontaneous physical activity

Eligibility Criteria:
Inclusion Criteria:

* Obese patients with BMI \> 35 kg/m²
* Continuous Positive Airway Pressure (CPAP) treatment and \> 4h observance per night to the patient with OSAS (obstructive sleep apnoea syndrome)
* Patients who give written consent
* Patients who subscribed social insurance

Exclusion Criteria:

* Cardiovascular or respiratory failure discovered at the moment of the inclusion in the study
* Contraindication to exercise
* Pregnant or breast-feed woman
* Patients under guardianship
* Imprisoned patients
Effectiveness of Telehealth Program in Patients With Type 2 Diabetes

Diabetes education is of great importance in the effective management of diabetes. Studies have shown that patients given diabetes education have positive developments in their ability to manage the disease and their attitudes towards the disease. The aim of the study is to compare the education given to individuals with Type 2 diabetes via mobile phone and the education given to individuals via brochures with conventional methods.

The use of telehealth technologies in the field of health is becoming more and more widespread. Telehealth has become one of the frequently used options in the follow-up process of chronic diseases such as diabetes, especially in recent years. Diabetes education is of great importance in the effective management of diabetes. Studies have shown that patients given diabetes education have positive developments in their ability to manage the disease and their attitudes towards the disease. The aim of the study is to compare the education given to individuals with Type 2 diabetes via mobile phone and the education given to individuals via brochures with conventional methods.

Eligibility Criteria:
Inclusion Criteria:

* Having a diagnosis of type 2 diabetes mellitus for at least 6 months,
* Those between the ages of 18-65,
* Receiving oral antidiabetic and/or insulin therapy,
* Having a mobile phone capable of receiving and playing video messages,
* Does not have hearing, speech and psychiatric problems that prevent communication,

Exclusion Criteria:

* Individuals who do not volunteered to participate in the study
* Patients who have hearing, speech and psychiatric problems that prevent communication
Pharmacological and Nonpharmacological Methods for Children in Venipuncture Pain

This study aimed to examine the effect of EMLA cream, cold spray, and Buzzy applied during venipuncture on the pain and fear levels of children aged 7-12 years.

The International Guide to Pediatric Anesthesia (Good Practice in Postoperative and Procedural Pain) recommends pharmacological and nonpharmacological methods to effectively manage and prevent acute procedural pain in children. Nonpharmacological methods alone or in combination with pharmacological methods help reduce pain, and therefore, have become popular especially in recent years. For pain management, nonpharmacological methods are easy to use, and cost- and time-effective methods with no side effects. Studies have evaluated a large number of pharmacological and nonpharmacological interventions for procedural pain management in children. However, most of those interventions are not used by healthcare professionals because they are expensive, time-consuming or hard to use. Therefore, easy-to-use, practical, non-invasive, cost-effective, and reusable pharmacological and nonpharmacological methods can be used especially in acute settings. EMLA cream, cold spray, and Buzzy examined in this study may serve as alternative effective pharmacological and non-pharmacological methods to reduce venipuncture pain and fear.

Eligibility Criteria:
Inclusion Criteria:

* being between the ages of 7 to 12 years,
* literate,
* requiring blood tests

Exclusion Criteria:

* having chronic diseases,
* hospital stay for treatment,
* visual, audio, or speech impairments,
* a history of allergies,
* mental disorders,
* history of sedative, analgesic, or narcotic use within 24 h before admission,
* inflammatory disease during admission.