cyrilzakka/clinical-trials huggingface dataset:
Transesophageal Echocardiography to Identify pAtients With Low Risk of Stroke in Atrial Fibrillation - TIARA Pilot Study

In this multi centre pilot study we will perform TEE in patients with AF who are eligible for VKA treatment. TTE will be used as pre-screening: if TTE shows left atrial abnormalities or aortic plaque, patients will be excluded from randomisation. TEE will be performed in all other patients to detect or exclude complex aorta plaques or signs of left atrial stasis. Three hundred patients who do not have these features on TTE will be randomly assigned to treatment with aspirin or VKA. Follow-up will be 1 year.

BACKGROUND Atrial fibrillation (AF) is an independent risk factor for stroke. Therapy with vitamin K antagonists (VKA) and aspirin reduces the risk of thromboembolism (TE) dramatically. Risk stratification is nowadays based on clinical characteristics. However, many high risk AF patients may actually be at low risk, identified by trans-oesophageal echocardiography (TEE).

HYPOTHESIS A comprehensive strategy of TEE based aspirin treatment in AF patients eligible for VKA therapy is safe and feasible.

OBJECTIVES

1. To show that TEE based aspirin treatment is safe when compared with VKA therapy.
2. To test the feasibility of TEE as a tool to detect all four echocardiographic features of high stroke risk.

METHODS In this multi centre pilot study we will perform TEE in patients with AF who are eligible for VKA treatment. TTE will be used as pre-screening: if TTE shows left atrial abnormalities or aortic plaque, patients will be excluded from randomisation. TEE will be performed in all other patients to detect or exclude complex aorta plaques or signs of left atrial stasis. Three hundred patients who do not have these features on TTE will be randomly assigned to treatment with aspirin or VKA. Follow-up will be 1 year.

EXPECTED RESULTS Application of a new echo-guided antithrombotic strategy as proposed herein is feasible and may help to reduce bleeding whilst stroke prevention is maintained. If the lower limit of the 95% confidence interval of the yearly incidence of the primary endpoint on aspirin remains below 4.4% then a large multi centre randomised controlled trial will be performed.

Eligibility Criteria:
Inclusion Criteria:

* Documented atrial fibrillation or atrial flutter, paroxysmal or permanent
* Conventional indication for VKA treatment
* Signed informed consent

Exclusion Criteria:

* Planned electro cardioversion
* Very high risk of TE (previous ischemic stroke or systemic TE, symptoms of heart failure or left ventricular dysfunction, mitral valve stenosis, hypertrophic cardiomyopathy)
* Indication for VKA treatment other than atrial fibrillation (e.g. mechanic valve prosthesis)
* Atrial fibrillation secondary to reversible diseases (e.g. thyrotoxicosis)
* Contraindication for treatment with VKA, aspirin, or clopidogrel
Monitoring and Management for Metabolic Side Effects of Antipsychotics

The purpose of this study is to test an approach for implementing guideline recommendations for assessing and managing metabolic side effects (including weight gain, diabetes, elevated lipids) in patients prescribed antipsychotic medications.

Treatment of psychotic disorders consists primarily of antipsychotic medications, which are associated with metabolic side effects such as overweight/obesity, diabetes, and dyslipidemia. Expert consensus and evidence-based recommendations have been developed for assessment and management of these conditions; however, research studies show deficits and delays in metabolic monitoring for patients prescribed antipsychotics. This purpose of this study is to test a quality improvement intervention to enhance implementation of recommendations for assessing and managing metabolic side effects in patients prescribed antipsychotic medications.

Study Objectives are:

* Objective 1: To test the effect of an Evidence-Based Quality Improvement/Facilitation (EBQI/F) intervention as an augmentation to a national implementation initiative on rates of monitoring for metabolic side effects of antipsychotics in sites likely to encounter greater challenges to implementation.
* Objective 2: To test the effect of the EBQI/F intervention as an augmentation to the national implementation initiative on management of metabolic side effects of antipsychotics in sites likely to encounter greater challenges to implementation.
* Objective 3: To assess the direct costs of the EBQI/F intervention, and explore potential variations in costs of the EBQI/F intervention in sites with lower versus higher organizational challenges.

Methods This study employs a cluster randomized design with eligible study sites including VA Medical Centers with 300 patients receiving a new antipsychotic prescription in the first six months of Fiscal Year 2008. Twelve sites have been recruited and matched according to level of organizational readiness-to-change. Randomization to intervention or control group was conducted within each of the six site-pairs. Study participants include VA employees involved in the monitoring and management of patients treated with antipsychotics at participating sites. The intervention involves researchers partnering with clinical stakeholders, offering tailoring in local implementation strategies to address barriers to metabolic side-effect monitoring and management. External facilitation to support, problem-solve and refine implementation will be provided for a six-month implementation phase. The effectiveness of the EBQI/F intervention combined with the ongoing national quality improvement initiative at six sites (intervention sites) will be compared to six matched comparison sites exposed to the national quality improvement initiative alone (control sites).

Eligibility Criteria:
Inclusion Criteria:

- Providers involved in antipsychotic management or management of metabolic side effects and related conditions

Exclusion Criteria:

- None
Multiple Ascending Dose Study of TRN-157 in Stable Mild and Moderate Asthmatics

This multiple ascending dose study is to determine the safety and bronchodilator activity of TRN-157 in 59 mild and moderate asthmatics.


Eligibility Criteria:
Inclusion Criteria:

Patients who meet the following criteria will be considered eligible to participate in the study:

* The patient is ≥ 18 and \< 70 years of age, and gives informed consent
* Clinical diagnosis of mild to moderate asthma of at least 6 months duration and age of onset \< 50 years
* Presently using ICS at moderate doses (equivalent to 200-800 µg of budesonide or 88-500 µg of fluticasone daily)
* ≥ 12% and ≥ 200 mL improvement in FEV1 to 4 puffs albuterol by metered-dose inhaler (MDI) at screening visit
* Patient is willing to use acceptable form of birth control during trial and for one month thereafter
* Ability to measure morning (AM) peak expiratory flow (PEF) on schedule using electronic peak flow meter (EPFM) and to complete the study diary correctly at least 70% of the time during the run-in period
* After 7 day withdrawal from LABA therapy and overnight withdrawal from SABA therapy (except rescue medication), patient has between 55% - 80% of predicted FEV1 at CV2

Exclusion Criteria:

A patient meeting any of the following criteria is not eligible for enrollment in the study:

* A clinical diagnosis of chronic obstructive pulmonary disease (COPD), chronic bronchitis, bronchiectasis, or other significant pulmonary disease other than asthma
* History of upper or lower respiratory infection within 4 weeks of screening
* History of asthma exacerbation requiring oral or systemic corticosteroids or hospital admission within 6 months of screening
* History of myocardial infarction, or cardiac conduction abnormalities, including but not limited to atrial fibrillation, and paroxysmal atrial tachycardia
* Hospitalization due to cardiac failure within the last 6 months
* History of narrow angle glaucoma or obstructive uropathy
* Current smokers or vapers, or former smokers with \> 10 pack-year (self-reported) history of smoking
* Patients who presently use the following medications will not be eligible for participation:

  * Long-acting muscarinic receptor antagonist (LAMA)
  * LABA (but may be withdrawn and converted to SABA x 7 days prior to entry)
  * Leukotriene pathway blockers
  * Anti-IgE antibody (Xolair) within last 6 months prior to CV1
  * Phosphodiesterase 4 (PDE4) inhibitors (e.g., Roflumilast)
  * Cromolyn
  * Methylxanthines (e.g., aminophylline and theophylline)
  * 5-Lipoxygenase inhibitor (e.g., Zileuton)
* Allergies to LAMA therapies
* History of life-threatening asthma exacerbation requiring ICU admission, mechanical ventilation, or tracheostomy
Metabolic Response Following Intake of 2 Metabolic Preconditioning Drinks

Surgical patients are usually starved for 8 to 12 hours before operation in order to reduce the chances of vomiting and other complications during the anaesthetic. Recent studies have suggested that this period of starvation might be harmful as it 'weakens' or 'stresses' the body before the operation. To avoid these harmful effects of starvation, patients are now given carbohydrate drinks (sugar-containing drinks that provide energy for the body) up to 2 hours before the operation. These drinks have been shown to make patients feel better, reduce sickness after the anesthetic/surgery and result in quicker recovery from operation. But the ways in which the sugar drinks have these beneficial effects on the body are unknown. The optimum time of giving these drinks to patients before operation is also unknown. This study will investigate the hormone responses of the body, following intake of 2 different carbohydrate drinks, in order to determine the optimum time of intake of these drinks in order to obtain the maximum benefits for the body.


Eligibility Criteria:
Inclusion Criteria:

* healthy male Caucasian volunteers aged 18-40 years,
* BMI of 20-25 kg/m2,
* able to give voluntary written informed consent to participate in the study, - able to understand the requirements of the study, including anonymous publications, AND
* agree to co-operate with the study procedure.

Exclusion Criteria:

* any history of acute or chronic illness, smoking, regular medication or substance abuse, OR
* have taken part in any other clinical study within the previous 3 months.
Effects of Different Type Exercise Trainings on Functionality in Older Fallers

The aim of this study to examine the effectiveness of different types of exercise trainings on functionality in older faller

Individuals participating in the study will be blinded and 30 elderly individuals will be included. Sociodemographic information of individuals, Mini Mental State Test, Fall Efficacy Scale, Dynamic Gait Index, Montreal Cognitive Assessment Scale, Daily Life Activities Scale for Vestibular Disorders, World Health Organization Quality of Life Scale-Elderly Module test results will be recorded. Hip flexors and abductors, m.quadriceps femoris and m.tibialis anterior muscle strength will be measured by manual muscle dynamometer. In balance assessments; sensory organization test and adaptation test of computerized dynamic posturography will be recorded. Individuals will be divided into 3 groups by blocking and stratification randomization method. All individuals in the group will perform vestibular exercise training twice a day for 8 weeks as a home exercise program. In the first group, vestibular exercise training will be used as a home program, in the second group, individual rehabilitation program will be applied to the computerized balance system and in the third group, square step exercises will be applied. Exercise training will be held 3 times a week for 8 weeks.

Eligibility Criteria:
Inclusion Criteria:

* 65 years and older individuals,
* Mini Mental State Examination Test score above 24,
* At least two falls in the last year
* Independent individuals in mobilization without walking aid

Exclusion Criteria:

* Cardiac diseases
* Pulmonary embolism and deep vein thrombosis in the last three months,
* A history of cerebral aneurysm or intracranial hemorrhage,
* Acute retinal hemorrhage or previous ophthalmic surgery,
* Active infection,
* Multiple organ failure,
* Terminal disease status,
* A history of fractures in the lower and upper extremities within the last three months,
* Severe hearing and vision loss,
* Patients with Alzheimer's disease, Parkinson's disease, dementia
* Patients diagnosed with Benign Paroxysmal Positional Vertigo,
* Those who have received exercise training in the last 6 months,
A Real-world Study to Assess Safety of OZURDEX® (Dexamethasone Intravitreal Implant) in Adult Participants With Diabetic Macular Edema in China

The dexamethasone intravitreal implant (OZURDEX) delivers dexamethasone gradually to the retina over time. It is an approved drug for the treatment of diabetic macular edema (DME). This study will assess the long-term safety and effectiveness of OZURDEX in adult participants with DME in the routine clinical setting in China.

Approximately 110 participants who are prescribed OZURDEX by their physicians will be enrolled in multiple medical institutions in China where OZURDEX is used for DME in routine clinical practice.

Participants will be followed for 24 months after the first administration of OZURDEX according to the routine clinical practice of the prescribing centers. A subsequent 30-day follow-up after the last dose will be performed to obtain information on any new or ongoing safety events and concomitant medications.

No additional burden for participants in this trial is expected.


Eligibility Criteria:
Inclusion Criteria:

- Participant scheduled to receive at least one intravitreal OZURDEX® injection for DME as per most current local approved label after its approval for DME in China.

Exclusion Criteria:

* Concurrent participation in interventional clinical research that required treatment or use of an investigational agent.
* Participants for whom OZURDEX® is contraindicated:

  * Participants with known hypersensitivity to OZURDEX® or any components of this product.
  * Participants with active or suspected ocular or periocular infections including most viral diseases of the cornea and conjunctiva, including active epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, mycobacterial infections, and fungal diseases.
  * Participants with late stage glaucoma that cannot be controlled with medication alone.
  * Aphakia with ruptured posterior lens capsule.
  * Eyes with anterior chamber intraocular lenses (ACIOL), iris- or scleral-fixated intraocular lenses, and ruptured posterior lens capsule.
Thermovision-controlled Lumbar Sympathetic Blockade in Chronic Limb-threatening Ischemia Treatment

Thermovision-controlled lumbar sympathetic blockade in chronic limb-threatening ischemia treatment

Chronic limb-threatening ischemia (CLTI), the end-stage of lower extremity artery disease (LEAD), occurs with growing prevalence around the globe and is associated with increased healthcare costs. CLTI is defined by the presence of LEAD in combination with rest pain, gangrene, or lower limb ulceration lasting more than two weeks. Despite unclear results of abdominal surgical lumbar sympathectomy, novel interventional minimally invasive fluoroscopy-guided procedures seem to be promising. A prospective interventional study will be conducted, primarily targeting patients afflicted by critical limb ischemia, with the incorporation of thermal vision control and tissue oxygen monitoring.

Eligibility Criteria:
Inclusion Criteria:

* Chronic limb-threatening ischemia-Patients with chronic leg pain for at least 6 months with intensity (VAS \>=5)
* those who (only if a signature was obtainable), or whose legal guardian,fully understood the clinical trial -details and signed the informed consent form

Exclusion Criteria:

* Chronic Venous Insufficiency
* women with positive a pregnancy tests before the trial or who planned to become pregnant within the following 3 years
* other patients viewed as inappropriate by the staff
* disagreement with participation in the study
Textured Insoles and Foot Massage in Individuals Diagnosed With Rheumatoid Arthritis

The aim of this study is to determine and compare the effects of using textured insoles and plantar massage on balance in patients with rheumatoid arthritis. Patients diagnosed with rheumatoid arthritis will be divided into two groups. In the first group the patients will be given plantar massage; in the second group, both plantar massage will be applied and the patients will use textured insoles in their indoor and outdoor activities. Plantar massage will be applied by the physiotherapist 3 days a week for 6 weeks; textured insoles will also be used for 6 weeks. All patients will be asked to complete the questionnaires, which assessed foot functionality, physical activity levels and quality of life. After each patients completed the questionnaire, the physiotherapist will perform plantar sensory and balance assessment. All assessments will be made before, after and 8 weeks after treatment.

In the solution of balance problems in rheumatoid arthritis (RA), successful results can be obtained with the correct sensory inputs from the sole of the foot. Even after 5 minutes of application with plantar massage, which is one of these methods, it has been observed that there is an improvement in balance reactions. Textured insoles are also one of the methods used to improve balance with the right sensory input. Both methods increase cutaneous receptor activity and ankle proprioception by providing increased afferent information; As a result of these effects, postural sway decreases, balance can be achieved on a narrower support surface, and postural control increases. Although the positive effects of plantar massage and textured insoles on balance are known, there are no studies in which these methods are used in RA patients. In our study, we aimed to determine and compare the effects of plantar massage, which provides short-term afferent input, and the use of textured insoles, which provide long-term afferent input, on balance in RA patients. For these purposes, plantar massage will be applied to one group, and plantar massage will be applied to the other group and textured insoles will be used. In this way, the effects on the balance will be observed and compared.

Eligibility Criteria:
Inclusion Criteria:

* 18-65 years old
* Being diagnosed according to the American College of Rheumatology (ACR)/EULAR 2010 rheumatoid arthritis diagnostic criteria

Exclusion Criteria:

* Having an orthopedic or neurological disease that may cause balance and sensory impairment
* Using drugs that may cause balance and sensory disorders
* Having undergone lower extremity surgery
* Having a neurological problem that may cause hearing or vision impairment
* Having a communication problem
* Having a history of major psychiatric illness
Arizona Alzheimer's Disease Research Center (ADRC)

The Arizona Alzheimer's Disease Research Center (ADRC) is the National Institute on Aging's (NIA's) first statewide AD Center (ADC), the only ADC in the Southwestern United States, and a leading example of statewide collaboration in biomedical research. It capitalizes on Arizona's strengths in brain imaging, genomics, computer science and biomathematics, the basic, cognitive and behavioral neurosciences, clinical, and neuropathological studies of AD, the discovery and evaluation of investigational treatments, and the study of normal cognitive aging.


Eligibility Criteria:
Inclusion Criteria:

* Cognitively normal persons, individuals with mild cognitive impairment or dementia who are at least 40 years of age.
* Willing to undergo health and cognitive assessments, and collection and banking of blood with venipuncture for genetic research, biomarker research, and DNA banking.

Exclusion Criteria:

* 1. Participants whose diagnosis is unclear and confounded by multiple possible factors are excluded. Participants with diagnoses of non-AD dementias are not excluded.

  2. Participants whose primary diagnosis is cognitive impairment due to a penetrating or single severe closed head injury, multiple sclerosis, brain tumor, metabolic or toxic encephalopathy, post-infectious (e.g., viral encephalitis, bacterial meningitis), paraneoplastic, primary psychiatric illness, or otherwise not deemed relevant to the intent of the Alzheimer Disease Center program are excluded.

  3. Procedure specific exclusion criteria also apply but this does not impact the participants ability to be included in the study.
A Study of KHK4827 (Brodalumab) in Subjects With Moderate to Severe Psoriasis in Korea

The primary objective of this study is to evaluate the efficacy and safety of KHK4827 in subjects with moderate to severe plaque psoriasis randomized in a double-blind manner to receive KHK4827 or placebo for 12 weeks


Eligibility Criteria:
Inclusion Criteria:

* Subject has had stable moderate to severe plaque psoriasis for at least 6 months
* Subject has involved BSA ≧ 10%, PASI ≧ 12, and sPGA ≧ 3 at screening and at baseline

Exclusion Criteria:

* Subject diagnosed with erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, or a medication-induced psoriasis, or other skin conditions (e.g., eczema) at screening that would interfere with study evaluations
* Subject scheduled to undergo a surgical intervention during the study period
* Subject has any active infection or history of infections as defined in the study protocol
* Subject has known history of Crohn's disease
* Subject has any other significant concurrent medical condition or laboratory abnormalities, as defined in the study protocol
* Subject has not stopped using certain psoriasis therapies as defined in the study protocol
* Subject has previously used any anti-IL-17 biologic therapy
* Subject is pregnant or breast feeding, or planning to become pregnant while enrolled in the study
* Women of child-bearing potential or fertile men who do not agree to use effective contraception from the day of providing consent through 12 weeks after the last dose of investigational product.
* Subject has known history or evidence of suicidal ideation (severity of 4 or 5) or any suicidal behavior based on an assessment with the Columbia-Suicide Severity Rating Scale (C-SSRS) at screening or at baseline
* Subject has severe depression based on a total score of ≥ 15 on the Patient Health Questionnaire-8 (PHQ-8) at screening or at baseline
* Subject has known history or evidence of a psychiatric disorder that, in the opinion of the investigator, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion
* Subject has known history of alcohol and/or substance abuse within the last 12 months"
Group Psychotherapy for People With HIV

This study will examine the effectiveness of supportive-expressive group therapy plus education compared with an educational intervention in improving the quality of life and promoting health-enhancing behavior of men and women living with HIV or AIDS.

The major goal of this project is to examine the effectiveness of supportive-expressive group therapy plus education in comparison to an educationally intervention in improving the quality of life and promoting health-enhancing behavior of men and women living with HIV/AIDS.

Eligibility Criteria:
Inclusion Criteria:

* 1) a positive HIV diagnosis (either symptomatic or asymptomatic), 2) at least eighteen years of age, 3) English language skill (to complete questionnaires and participate, if assigned, to the group psychotherapy condition) and, 4) geographical proximity to groups in order to attend if assigned.

Exclusion Criteria:

* 1) severe psychiatric disorders (i.e. schizophrenia or other psychotic disorders)who would not be appropriate for participating in the group intervention, 2) active tuberculosis, 3) acute intoxication, 4) participation in an ongoing HIV/AIDS support group or 5) suicidal/homicidal ideation.