cyrilzakka/clinical-trials huggingface dataset:
Safety of the PET-511BTM Transesophageal Transducer

The purpose of this study is to demonstrate the safety of the redesigned transesophageal echocardiogram (TEE) transducer as it is inserted and transitioned into the esophagus through the mouth.

The PET-511BTM is a multiplane transesophageal transducer designed for use with Toshiba Diagnostic Ultrasound Systems for the visualization of the heart (and other organs) as a real-time ultrasound image. It is inserted into the esophagus through the mouth to visualize a plane of the heart through the esophageal wall.

The objective of the study is to demonstrate the safe use of the redesigned Toshibal TEE transducer for ease of passage and during transitioning into and down the esophagus to complete a normal TEE study.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients between the ages of 20 and 80
* Informed consent understood and signed
* Compliance with post-treatment follow-up protocol requirements

Exclusion Criteria:

* None
Evaluation of a Mindfulness Intervention to Prevent Chemo-brain in Women Preparing for Chemotherapy for Breast Cancer

This clinical trial tests how well a mindfulness intervention helps the prevention of chemotherapy-brain (chemo-brain) in women preparing for chemotherapy for breast cancer. Cognitive dysfunction after chemotherapy has been well-documented. Factors that have been used to document and/or have been correlated with chemo brain include self-report and structural brain changes including volume loss. Mindfulness is a type of meditation practice that can be learned to support well-being and decrease stress. Mindfulness is an approach that helps the person increase their awareness of the present moment without judgement. There are data that mindfulness may increase attention and concentration which may prevent some of the side effects from chemotherapy

PRIMARY OBJECTIVES:

I. Assess the feasibility of an 8-week mindfulness intervention in women preparing for chemotherapy for breast cancer.

II. Evaluate cognitive dysfunction related factors as an exploratory objective: cognitive function, quality of life, inflammatory markers, functional magnetic resonance imaging (fMRI) brain imaging, and a record of mindfulness practice.

OUTLINE:

Patients participate in a mindfulness program composed of topics that include mindfulness of breathing and the body scan, mindful eating, mindful activity, mindfulness in daily life, expanding the field of awareness, and maintaining a flexible mindfulness practice weekly over 2.5 hours for 8 weeks. Patients also undergo blood sample collection and fMRI on the study.

After completion of study intervention, patients are followed up at 3 months.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Breast cancer diagnosis preparing to undergo chemotherapy

Exclusion Criteria:

* Under the age of 18
* Cannot provide informed consent
Arthroscopic Versus Open Excision of Dorsal Wrist Ganglion

compare recurrence rates after open and arthroscopic excision of dorsal wrist ganglion

DORSAL GANGLIONS (DGS) are one of the most frequent problems of the wrist. They represent benign soft tissue tumors that frequently remain asymptomatic. Suggested causes include trauma to the scapholunate joint, degeneration of tissue lining a tendon or sheath near the joint, and synovial herniation in most cases, diagnosis is based on history and physical examination. Patients seek treatment when these ganglions become associated with pain, weakness, interference with activities, and an increase in size Other than observation, nonoperative treatment such as closed rupture, ganglion puncture, and needle aspiration is associated with relatively higher rates of recurrenceas high as 78%. Surgical treatment with either open or arthroscopic excision is therefore offered with a lower risk of recurrence. Whereas open excision has historically been the traditional method of surgical treatment, arthroscopic excision has been suggested as a potentially more favorable alternative. Proponents of wrist arthroscopy proclaim an advantage of decreased postoperative pain, earlier return of functions, and a smaller incision. Moreover, preliminary and subsequent studies have described arthroscopic DG excision as having equal or lower rates of recurrence. However, the results of arthroscopic versus open procedures have never been directly compared.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a primary, simple DG with no underlying pathology of the wrist who sought surgical treatment.

Exclusion Criteria:

* 1. Prior ganglion treatment (rupture, puncture, aspiration, or excision) 2. Previous surgery 3. History of a fracture 4. Ligamentous tear or wrist instability 5. Patients with major medical problems 6. Unacceptable anesthetic risks, 7. Acquired or congenital abnormalities of wrist function or motion
Impact Of Muscle Vibration On Gait Control

This is a single-site interventional open label pilot study of a non-significant risk medical device on patients with defined peripheral neuropathy secondary to chemotherapy (N=10). Patients who have received chemotherapy and have evidence of neuropathy will be seen at MD Anderson. Their severity of neuropathy will be documented and assessed by physical therapy, occupational therapy and based on self-reported activities of daily living (ADL) impairment.

Primary Objective:

To assess the effect of a vibrating device applied to selected muscles on the step

Secondary Objectives:

* To summarize the adverse events of different levels from using the vibrator device in oncologic AYA patients visiting the outpatient clinic.
* To summarize the irritation, pain, and sensation of the application of vibration by the AYA patients, as determined by the survey during the application

Eligibility Criteria:
Inclusion Criteria:

* Subjects between the ages of 6 and 39 years.
* Study subjects, or their parent/legal guardian for subjects \<18 years, must be able to understand the purpose and risks of the study and to provide signed and dated informed consent and authorization to use confidential health information in accordance with national and local subject privacy regulations.
* History of any type of cancer-
* Diagnosed with peripheral neuropathy-associated gait dysfunction as defined by the treating physician.
* Able (in the Investigators estimation) and willing to comply with all study requirements.
* Subjects must be able to walk; assistance of a walker or similar support apparatus is allowed.
* Patients with ankle foot orthosis (AFOs) are allowed but will need to be removed prior to testing.

Exclusion Criteria:

* Participants with amputations, prosthetics, congenital malformations or any severe lower extremity deformities affecting gait before trials.
* Abnormalities of the lower extremities as determined by the investigator.
* Unstable participants or participants with hypotension (systolic blood pressure \<90 and diastolic blood pressure \< 60mmHg).
* Any other significant disease or disorder which, in the opinion of the investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.
* Other unspecified reasons that, in the opinion of the Investigator make the subject unsuitable for enrolment
* Pregnant women
* Children \<15 years old
* Blind
Plasma Adsorption in Patients With Confirmed COVID-19

To characterize the ability of the D2000 Cartridge in combination with the Optia SPD Protocol to reduce the morbidity and mortality associated with SARS-CoV-2 infection in patients admitted to the ICU.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old
* Admitted to ICU
* Diagnosis of SARS-CoV-2 with any one of the following conditions:

  1. Early acute lung injury (ALI)/early acute respiratory distress syndrome (ARDS); or
  2. Severe disease, defined as:

     1. dyspnea,
     2. respiratory frequency ≥ 30/min
     3. blood oxygen saturation ≤ 93%
     4. partial pressure of arterial oxygen to fraction of inspired oxygen ratio \< 300, and/or
     5. lung infiltrates \> 50% within 24 to 48 hours; or
  3. Life-threatening disease, defined as:

     1. respiratory failure,
     2. septic shock, and/or
     3. multiple organ dysfunction or failure.
* Patient fact sheet is provided to the subject.
* Subject or legal representative is able and willing to give informed consent. If authorized by the IRB, emergent plasma adsorption with the D2000 cartridge may be initiated prior to consent.

Exclusion Criteria:

* Treatment limitation or a do not attempt to resuscitate in place
* Pregnancy
* Significant or uncontrolled bleeding
* In the opinion of the investigator, any other condition that precludes plasma adsorption with the D2000
Effects of a Personalized Web-based Antenatal Care Planner

Many women are turning to the Internet to meet their health information needs, but the large amount of information available, as well as the unknown reliability and applicability of information can be overwhelming. Studies in specific patient populations have determined that patients given access to personalized, on-line medical information are more satisfied with their care than patients provided generalized information. None of these studies have looked at whether this type of patient education would be helpful for pregnant women. This study is being done to determine whether pregnant women who have access to their own health records and personalized health information over the Internet are more satisfied with their prenatal care, and if they are more compliant with health visits and tests, compared to pregnant women who receive only generic pregnancy information on the Internet and from pamphlets

Many women are turning to the Internet to meet their health information needs, but the large amount of information available, as well as the unknown reliability and applicability of information can be overwhelming. Studies in specific patient populations have determined that patients given access to personalized, on-line medical information are more satisfied with their care than patients provided generalized information. None of these studies have looked at whether this type of patient education would be helpful for pregnant women. This study is being done to determine whether pregnant women who have access to their own health records and personalized health information over the Internet are more satisfied with their prenatal care, and if they are more compliant with health visits and tests, compared to pregnant women who receive only generic pregnancy information on the Internet and from pamphlets

Women are being randomly assigned to receive secure access to pregnancy health information links chosen by the centre's physicians, or to receive these links with access to their online personal health that includes the antenatal record and a section of their care planner, from the centre's electronic medical record

Eligibility Criteria:
Inclusion Criteria:

* less than 28 weeks pregnant access to Internet

Exclusion Criteria:

* cannot speak/read English and no translator
DENEX Renal Denervation in Patients With Uncontrolled Hypertension: Safety Study

The study is the multicenter pilot study to obtain an assessment of the safety of renal denervation in the patients with uncontrolled hypertension on standard medical therapy in Korea.

DENEX system developed by Handok Kalos Medical Inc. is a renal nerve blocking system to efficiently block the sympathetic nerve of the kidney with minimal invasive procedure. It was developed to block the sympathetic nerves distributed in blood vessel wall by delivering high frequency energy to the renal artery for the purpose of treating hypertension.

Eligibility Criteria:
Inclusion Criteria:

1. Individual is ≥ 20 years of age at time of consent
2. Individual has office systolic blood pressure (SBP) of ≥ 150 mmHg
3. Individual has daytime 24-hour Ambulatory Blood Pressure Monitoring (ABPM) SBP of ≥ 140 mmHg
4. Individual maintains the following 3 antihypertensive medications: thiazide-type diuretic, calcium-channel blocker, and angiotensin-converting enzyme inhibitor or angiotensin receptor blocker (for at least 6 weeks before the screening visit) that is expected to be maintained without changes for at least 6 months.

Exclusion Criteria:

1. Main renal artery contains renal artery stenosis \>50%
2. Individual has confirmed anatomical findings in kidneys or renal arteries through CT scan or angiogram
3. Undergone prior renal angioplasty
4. Main renal arterial vessel for each kidney \<4 and \>8 mm in diameter, or \<20 mm length
5. Individual has an Estimated glomerular filtration rate \<45 mL/min/1.73 m2 at screening visit
6. Individual has experienced myocardial infarction, unstable angina pectoris, syncope, or a cerebrovascular accident within 3 months of the screening period, or has widespread atherosclerosis, with documented intravascular thrombosis or unstable plaques
7. Individual has Hemodynamically or echocardiography significant valvular heart disease
8. Individual has secondary hypertension (pheochromocytoma, Cushing syndrome,coarctation of the aorta, renovascular hypertension, primary hyperaldosteronism, or other secondary hypertension)
9. Individual has documented primary pulmonary hypertension
10. Individual has orthostatic hypotension with symptom
11. Individual requires chronic oxygen support for sleep apnea
12. Individual is taking chronic NSAIDs (Non-Steroidal Anti-Inflammatory Drugs). Only, Aspirin is permitted for cardiovascular disease prevention
13. Individual has Type 1 diabetes mellitus
Short Transverse Versus Conventional Hockey Stick Incision in Kidney Transplantation

Today the minimal invasive access is used for a lot of different operations. This technique takes the advantage of less postoperative pain, better cosmetic results, and a lower surgical complication rate (e.g. hernia, wound infection).

Especially patients under immunosuppressive therapy could benefit from this technique. First results in minimally invasive kidney transplantation indicate that it may be performed quickly and safely. Benefits are expectable on postoperative pain, recovery, and surgical complications. Another retrospective study showed lower rates of hernia, abdominal wall relaxations, and a better postoperative cosmetic.

The aim of this study is to compare the classic hockey stick incision with a minimal invasive incision in a randomized clinical trial.


Eligibility Criteria:
Inclusion Criteria:

* Age equal or over 18 years
* Sole kidney transplantation
* Consent form
Intensive Ambulance-delivered Blood Pressure Reduction in Hyper-Acute Stroke Trial

A multicentre, ambulance-delivered, prospective, randomized, open-label, blinded endpoint (PROBE) study to assess the effects of hyperacute intensive blood pressure (BP) lowering initiated in ambulance setting on (i) functional outcome in patients with acute stroke (ii) safety in patients with confirmed acute stroke and other conditions that were initially suspected as acute stroke (i.e. stroke mimic).

As an investigator initiated and conducted, multicentre, ambulance-delivered, prospective, randomised, open-label, blinded outcome (PROBE) study. INTERACT4 aims to evaluate the effects of functional outcome according to an ordinal analysis of the full range of scores on the mRS, the safety in all randomised patients; reperfusion treatment (thrombolysis and/or thrombectomy) related symptomatic ICH (sICH, according to standard definitions), infarct size, the time to and overall rate of reperfusion treatment in AIS patients; hematoma volume and early expansion in ICH.

Eligibility Criteria:
Inclusion Criteria:

1. age ≥18 years;
2. Acute syndrome that is due to presumed acute stroke, defined as FAST（Face, Arm, Speech, Time） scores of ≥2 with an arm motor deficit and time ≤2 hours from last seen well;
3. Systolic BP ≥150
4. Able to provide brief informed consent (if a waver of consent is not approved by the ethics committee)

Exclusion Criteria:

1. Coma - no response to tactile stimuli or verbal stimuli;
2. Severe co-morbid disease (e.g. cancer, chronic airflow disease, severe dementia,severe heart failure,pre-stroke disability\[needed help\]);
3. History of epilepsy or seizure at onset;
4. History of recent head injury (\<7 days);
5. Hypoglycemia(glucose\<2.8mmol/L)
Trial and Cost Effectiveness Evaluation of Intra-arterial Thrombectomy in Acute Ischemic Stroke

THRACE is a controled, multicenter and randomized trial.

The primary objective of this study is to determine whether a combined approach intravenous thrombolysis (IV) + Mechanical thrombectomy is superior to the reference treatment with IV thrombolysis alone, in the 3 hours of onset of symptoms in patients with occlusion of proximal cerebral arteries and with a neurological impairment accident (National Institutes of Health Stroke Scale \[NIHSS\] ≥ 10).

The second objective is to determine the cost-effectiveness of this procedure compared to the standard (IV thrombolysis). The assumption is that the combined approach, by improving the clinical outcome and speed recovery, allows for lower overall costs to the IV thrombolysis in 3 months and less than or at worst neutral to 1 year.


Eligibility Criteria:
Inclusion Criteria:

* 10\<=NIHSS Score=\<25
* Symptoms onset less than 4 hours
* Occlusion of the intracranial carotid, the middle cerebral artery (M1) or the upper third of the basilar

Exclusion Criteria:

* Contraindications for intravenous thrombolysis
* Occlusion or stenosis of the pre-occlusive cervical internal carotid artery ipsilateral to the lesion
* Any cause local prohibiting femoral catheterization
The Effect of Biofeedback-Based Virtual Reality Game on Children

The needles of port catheters, which are often used in childhood cancer treatment, must be changed every 5-7 days, which causes pain, anxiety, and fear in children every 5-7 days In recent years, the usage of virtual reality has grown to distract children during port catheter needle insertion. But it's not always easy for children to switch their attention to something else. A good child distractor must be sensory-stimulating, developmentally appropriate, and highly interactive.

Today, virtual reality applications have advanced, and software that provides biofeedback with breathing has improved engagement with the user. Our aim in this study is to examine the effect of biofeedback-based virtual reality games on pair, fear and anxiety levels during insertion of port needle insertion in children.

The randomized control trial design will be used, and The CONSORT list will be used to guide the research. This study will be conducted at the 62 pediatric oncology patients (31 experiment/ 31 control) aged 6-12 years. This study will be carry out in a university hospital in Istanbul, Turkey between January 2023, and June 2023. The research data will collect from the children's self-reports and parents through a survey form and scales. Children's pain will evaluate by the children and parent with Wong-Baker Faces Pain Rating Scale, child fear will evaluate by the children and parent with 'Child Fear Inventory', and child anxiety will evaluate by the children and parent with 'Child Anxiety Statement Scale'.

Eligibility Criteria:
Inclusion criteria:

* Between the ages of 6-12,
* Requires venous access
* Diagnosed with childhood cancer,
* Volunteers with at least one venous access experience.

Exclusion Criteria:

* With neurodevelopmental delay,
* Difficulty in verbal communication
* Auditory or visual impairment
* Those who have used analgesics in the last 24 hours and have a history of needle phobia.
Dysfunctional Attention Processes in Fear of Blushing: Specificity and Changeability

Blushing is associated with a heightened self-focused attention. In our study we are interested if this self-focused attention can be shown experimentally and if it can be changed by therapy and training. For the experimental part of the study, we want to compare blushing fearful individuals to social anxious participants who are not fearful of blushing and to healthy controls who report to blush either seldom or quite often. In the therapeutical part of our study, we compare an attention training to the standard cognitive behavioral therapy for social anxiety disorder in an intensive group therapy approach.

Fear of blushing is a specific syndrome in social anxiety disorder. Although attentional biases for social anxiety disorders have often been reported, specific data for fear of blushing are still missing. In this study, dysfunctional attention processes are examined by the use of various questionnaire measures and attention tests (e.g. Stroop test, task switching paradigm) comparing fear of blushers, other social phobia patients, healthy volunteers who report to blush seldomly respectively often. The second goal of the study is to examine if these attention processes can be changed by training and therapy. Therefore, individuals who fulfill DSM-IV criteria for social anxiety disorder and report fear of blushing as main problem, are treated with attention training and with CBT for social anxiety disorder. Therapy will be held in the form of intensive weekend group therapy. Differences in outcomes for both therapy types and in changeability of attention processes on objective test data are examined. Stability of results are tested up to 6-month and 12-month after post-assessment.

Eligibility Criteria:
Inclusion Criteria:

* Social anxiety disorder (DSM-IV criteria) and fear of blushing as main complaint
* age: 18-70

Exclusion Criteria:

* acute severe depression or bipolar disorder
* any disorder of ICD group F2
* acute and severe substance misuse
* any bodily illness which hinders from study participation