cyrilzakka/clinical-trials huggingface dataset:
Study to Evaluate Pharmacokinetics and Tolerability of Multiple Doses of Eslicarbazepine Acetate and Oxcarbazepine

This purpose of this study is to measure the concentrations of two anti-epileptic drugs (Eslicarbazepine acetate and oxcarbazepine) and their metabolites in the cerebrospinal fluid and blood plasma of healthy subjects and also to assess how these drugs are tolerated.


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects
* Aged 18-55 years
* Body mass index (18.5-29 kg/m3)
The Israeli MGuard Registry

the objective of the Israeli MGurad Registry is to evaluate the 'Real World' Clinical Performance of the InspireMD MGuard Coronary Stent System

A Prospective, Observational, Multicenter Registry The primary objective of this registry is to document the safety and overall clinical performance of the MGuard Coronary Stent System in a "real world" patient population requiring stent implantation.

The secondary objective is to assess the event rate in patient subgroups with specific clinical indications and/or vessel and/or lesion characteristics.

Eligibility Criteria:
Inclusion Criteria:

* Patient is \> 18 years of age
* The patient has consented to participate by signing the "Patient Informed Consent Form"
* Patient is suitable for implantation of one or more MGuard Stent System in one or more target lesions
* Target lesion(s) are according to the Indications for Use and Israeli regulatory approval of the MGuard Stent System
* The patient is willing and able to cooperate with registry procedures and required follow up

Exclusion Criteria:

* Heavily calcified target lesions
* Target lesions with side branch bigger then 2.5mm
* Target lesions which are distal to newly stented lesion (less than 1 month).
* Women with known pregnancy
* Current medical condition with a life expectancy of less than 12 months
* Patients with medical conditions that preclude the follow-up as defined in the protocol or that otherwise limits study participation
Skin Cancer Diagnostics Using Photoacoustic Imaging

In this clinical study, photoacoustic imaging will be used on patients with suspected skin cancer (primarily melanoma, basal cell carcinoma, and squamous cell carcinoma) to determine the tumor borders both superficially and at a depth.

The study will employ multispectral photoacoustic imaging in the spectral range between 680-970 nm to scan suspected skin tumors both in vivo and ex vivo. The hyperspectral data will then undergo rigorous spectral analysis with the objective to identify the spectral fingerprints associated with healthy tissue and tumor. Thereafter, a classification algorithm will be used to determine whether a pixel in the acquired image more likely identifies with healthy tissue or tumor, which is then repeated for all pixels in the images. As such, a 3D image can be reconstructed in which the tumor is visibly contrasted from healthy tissue. Achieving this goal will facilitate the diagnostic procedures and greatly reduce waiting times, clinical costs and potential patient suffering.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled to perform surgical excision of lesion(s) suspected to be tumors.

Exclusion Criteria:

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Attention Bias Modification Treatment (ABMT) for Anxiety Disorders in Youth Who do Not Respond to CBT

First-line psychosocial treatments for anxiety disorders in children are largely exposure-based cognitive behavioral therapies (CBTs). Despite strong evidence supporting CBT's efficacy, for up to 50% of youth patients, symptoms of anxiety persist after a full course of treatment. What are the treatment options for these youth? Unfortunately, there is not a single empirical study in the youth anxiety treatment literature that has systematically examined treatment augmentation for youth who fail to respond to CBT. Empirical efforts to address this issue are important because youth who do not respond to CBT continue to suffer emotional distress and impairment associated with anxiety disorders. This study will address this gap via double-blind randomized controlled trial of Attention Bias Modification Treatment (ABMT) for anxious 10-18 year-olds who did not respond to standard CBT. Attention biases in threat processing have been assigned a prominent role in the etiology and maintenance of anxiety disorders. ABMT utilizes computer-based protocols to implicitly modify biased attentional patterns in anxious patients. Here, participants will be CBT non-responders who will be assessed by using clinical interviews and parent- and self-rated questionnaires before and after eight sessions of ABMT or placebo control, and again at an eight-week follow-up. We expect to see reduction in anxiety symptoms in the Attention Bias Modification Treatment (ABMT) group relative to the placebo control group. We also expect the findings to inform pathways to treatments for anxious children who do not respond to current standard first-line therapy, and to provide initial information on mechanisms of ABMT efficacy.


Eligibility Criteria:
Inclusion Criteria:

To be included all youth must:

1. have received a full course of CBT and were deemed treatment non-responders.
2. they must still have a primary diagnosis of GAD, SOP, or SAD.
3. if they have comorbid attention deficit hyperactivity disorder (ADHD) or depressive disorders, it must be treated with medication and stable.
4. if they have tics or impulse control problems, those problems must be treated with medication and stable and cause minimal or no impairment.

Exclusion Criteria: To be excluded youth must:

1. meet diagnostic criteria for Organic Mental Disorders, Psychotic Disorders, Pervasive Developmental Disorders, or Mental Retardation.
2. show high likelihood of hurting themselves or others.
3. have not been living with a primary caregiver who is legally able to give consent for the child's participation.
4. be a victim of previously undisclosed abuse requiring investigation or ongoing supervision.
5. be involved currently in another psychosocial treatment.
6. have a serious vision problem that is not corrected with prescription lenses.
7. have a physical disability that interferes with their ability to click a mouse button rapidly and repeatedly.
Cardiac Water and Fluoromethane Cardiac PET

In this study we are looking at the blood flow to the heart using two different chemical tags or tracers that give off a low level of radiation. The tracers used in this study are called O15-water and F17-fluoromethane. These tracers mix with the blood and will move through the body. The researchers will use positron emission tomography (PET scans)to track the tracers as they moe through the heart and chest.


Eligibility Criteria:
Inclusion Criteria:

* 1. Age 18 to 40 years old 2. Willing to provide written informed consent

Exclusion Criteria:

* 1. A history of CAD 2. A history of active bronchospasm or asthma on theophylline bronchodilators 3. A history of any cardiac risk factors including: HTN, Diabetes, Hyperlipidemia, Smoking, and premature CAD in immediate family member 4. A history of liver disease or other significant disease 5. Females who are pregnant or lactating
A Phase IV Study to Evaluate Safety, Tolerability and Effectiveness of Rivastigmine Patch 15cm2 in Patients With Severe Dementia of the Alzheimer's Type.

This was a multicenter, prospective, phase IV study evaluating safety, tolerability and effectiveness of rivastigmine 27 mg -15 cm\^2 transdermal patch prescribed in patients with severe dementia of the Alzheimer's type as per discretion of treating physician.

This was a multicenter, prospective, single-arm, open-label, phase IV study to evaluate safety, tolerability and effectiveness of Rivastigmine 27 mg -15 cm\^2 transdermal patch prescribed in patients with severe dementia of the Alzheimer's type as per discretion of treating physician. Male and female patients who were treated according to local routine clinical practice were enrolled in the study upon signing informed consent. The prescription decision was independent of the decision for inclusion in the study.

Eligibility Criteria:
Inclusion Criteria:

1. Patients willing to participate in the study by providing written informed consent.
2. Patients diagnosed with severe dementia secondary to Alzheimer's disease (AD) 3 .Patient's prescribed with rivastigmine 27mg -15 cm\^2 transdermal patch as per discretion of treating physician

Exclusion Criteria:

1. Contraindication as per PI
2. Patients simultaneously participating in other studies
3. Use of other investigational drugs within 5 half-lives of enrollment, or within 30 days (for small molecules) /until the expected PD effect has returned to baseline (for biologics)\], whichever is longer.
4. History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes
Response To Cardiac Resynchronization Therapy In Heart Failure: Role Of Arterial Stiffness

To determine if arterial stiffness as measured by non-invasive pulse wave velocity can predict the response to resynchronization therapy in heart failure.

The patients receiving CRT are medically refractory, symptomatic, NYHA class III or IV disease and QRS duration of 130 m sec or greater, and a left ventricular ejection fraction of 30 percent or less.

The pulse wave velocity between carotid and femoral (PWVcf) will be recorded in each subject at base line (before and after CRT), at one month (after AV delay optimization) and again at 6 months after CRT. The arterial pulse wave is recorded at a proximal artery, such as the carotid artery, and as well as at a distal artery, such as the femoral artery. The superficial location of the carotid and femoral arteries means that their pulse waveforms are readily measured noninvasively using the M Hz Doppler probe, and between these two sites the pulse wave has to travel through most of the aorta. The time delay between the arrival of a predefined part of the pulse wave, such as the foot, at these 2 points is obtained by gating to the peak of the R-wave of the ECG. The distance traveled by the pulse wave is measured over the body surface and PWV is then calculated as distance/time (m/s).

Clinical evidence of response: Either one or more of the following: 1) Improvement in NYHA functional classification, 2) Improvement in 6 minute walking distance. 3) Change in functional class, exercise tolerance while the heart is getting smaller on CXR. 4) Stabilization of patient CHF even without subjective improvement over 6 months (remaining class III rather than progressive to class IV). Imaging evidence of response: 1) Increase in left ventricular ejection fraction. 2) Reduction of mitral regurgitation. 3) Reduction of LV volume signifying reverse remodeling.

Eligibility Criteria:
Inclusion Criteria:

* The patients receiving CRT are medically refractory, symptomatic, NYHA class III or IV disease and QRS duration of 130 m sec or greater, and a left ventricular ejection fraction of 30 percent or less.
* All individuals are carefully selected after appropriate clinical evaluation as determined by the treating physicians to exclude possible reversible causes of heart failure.

Exclusion Criteria:

* Patients with permanent atrial fibrillation and non-palpable carotid and/or femoral pulses will be excluded due to technical limitations of the procedure used for the measurement of arterial stiffness.
Effectiveness of Proprioceptive Exercises Program in Patients With Carpometacarpal Joint Osteoarthritis

Objective: To establish the effectiveness of a proprioceptive training program as a complementary therapy for a traditional protocol in position control, pain intensity, upper limb function and occupation performance for patients with thumb CMC joint OA.

Methods: Standard conservative thumb CMC joint OA treatments were received for both the control (n=26) and experimental groups (n=26) for a period of 12 weeks. The experimental group received a proprioceptive training program during the same intervention period, which was conducted twice weekly (24 sessions). The severity of pain with activity was measured according to the visual analog scale (VAS). QuickDASH questionnaire was used to measure upper extremity function. Patient's occupational performance was measured with the Canadian Occupational Performance Measure (COPM) and proprioception was assessed using Joint position sense (JPS) testing.


Eligibility Criteria:
Inclusion Criteria:

Patients were included if they satisfied the following inclusion criteria; over 18 years of age with a diagnosis of grade I, II or III thumb CMC joint OA in their dominant hand according to the Eaton Classification Stage (14), a minimum pain rating of 4/10 on the Visual Analogue Scale (VAS) during activities of daily living (ADLs) at the time of the therapy initial evaluation,and the ability to read and understand the patient information sheets and exercises.

Exclusion Criteria:

Patients were excluded from participation if they had a neurological disorder affecting the upper limb, had received specific treatment for hand or thumb pain in the same limb in the last 6 months including an intra-articular joint injection to wrist, fingers, or thumb, had fractures or a significant hand injury or previous surgery to the wrist or hand, or had hand or finger tenosynovitis and/or Dupuytren disease. We also excluded patients with cognitive impairments who were not able to understand the informed consent and/or exercise program.
A Randomized Controlled Trial of Acupuncture in Treating Migraine

Migraine without aura is a common kind of nervous system diseases that can easily cause recurrent headache, leading to severe impacts on quality of life and health care costs. Current therapeutic options for migraine without aura mainly include flunarizine hydrochloride that can relieve vasospasm. Nevertheless, the efficacy of flunarizine hydrochloride is always limited by inevitable side effects, which result in poor compliance of patients. Moreover, for some most suffering patients, the control of pain is often unsatisfactory despite of the administration of complex treatment combinations.

As a non-pharmaceutical therapy, acupuncture is widely used for a wide range of pain conditions. Thus, it might be an alternative treatment for migraine without aura. The aim of this randomized controlled trial is to investigate the efficacy and safety of acupuncture therapy in patients with migraine without aura from the perspective of Regulating Ying and Wei.

This randomized controlled trial will enroll 96 migraine patients without aura from the Third Affiliated Hospital of Zhejiang Chinese Medical University. All patients will be randomly assigned to either the acupuncture combined with placebo group or sham acupuncture combined with medication group through a randomization system. Primary outcome will be pain intensity assessed by visual analogue scale (VAS) scale. Secondary outcomes will include migraine-specific quality of life (MSQOL) scale and headache needs assessment survey (HANA) questionnaire scale.

Eligibility Criteria:
Inclusion Criteria:

1. Patients meet the diagnostic criteria of migraine without aura;
2. 25 ≤ age ≤50 years, male or female;
3. The efficacy of drugs and other therapeutic methods is not obvious; the frequency of migraine attacks in the past 3 months is more than twice a month;
4. Drug treatment for migraine without aura is stopped for at least one week;
5. Participants can understand the study protocol and written informed consent is signed.

Exclusion Criteria:

1. Patients have severe complications in cardiovascular, liver, kidney, hematopoietic and other systems;
2. Pregnant or lactating women;
3. Patients have spontaneous bleeding tendency so it is not suitable for them to receive acupuncture;
4. Patients have an allergic history of flunarizine hydrochloride or a history of depression;
5. Patients are diagnosed as psychosis.
Performance of Lung Ultrasonography for Endotracheal Tube Positioning in Neonates

Lung Ultrasonography (US) has been shown to be effective for verifying endotracheal tube (ETT) position in adults and children but has been less studied in neonates. The aim of this study is to evaluate the performance of lung US in determining correct ETT position in neonates, in comparison with X Ray


Eligibility Criteria:
Inclusion Criteria:

* Newborns
* treated with mechanical ventilation
* and required chest X ray for determining ETT position
* hospitalised in neonatal intensive Care unit , Limoges, France
* signed parental inform consent

Exclusion Criteria:

* Congenital heart disease
Merging Yoga and Group OT (MY-OT) to Improve Balance and Decrease Fall Risk After Stroke

The long-term goal of this project is to advance best practices in occupational therapy (OT) to manage fall risk factors and reduce fall rates in older adults with stroke. To address this long-term goal, this team previously developed and pilot-tested a therapeutic yoga intervention to improve balance, balance self-efficacy, and fear of falling and a group OT intervention to improve the management of fall risk factors and fear of falling. The success of both prior studies supports Merging Yoga and group OT to improve balance, balance self-efficacy, and fall risk factor management. The objectives of this feasibility study are to 1) further develop, standardize, and manualize the MY-OT intervention and 2) assess change in balance, balance self-efficacy, and fall risk factor management.

8 week intervention of yoga plus occupational therapy. The objectives of this feasibility study are to 1) further develop, standardize, and manualize the MY-OT intervention and 2) assess change in balance, balance self-efficacy, and fall risk factor management.

Eligibility Criteria:
Inclusion Criteria:

* stroke \>6 months prior
* 59 years or older
* prior fall or Fear of Falling (FoF)
* completed all stroke rehabilitation
* able to stand with or without an assistive device
* impaired balance with a score of \<46 on the Berg Balance Scale
* able to speak English
* score \>4 out of 6 on the short Mini Mental Status Exam (Callahan, Unverzagt et al., 2002)
* able and willing to attend twice weekly sessions for 8 weeks.

Exclusion Criteria:

* people with life expectancy \<9 months;
* inability to attend sessions due to unresolved transportation issues;
* inability or refusal to provide informed consent
A Home-based Training Program for Elderly Patients With Dementia

The illness course and symptoms of dementia is usually very long and characterized with behavioral, psychological and physical changes. Family caregivers' stresses change during the illness trajectory as well. The purpose of this study is to compare the costs and effectiveness of two care models- home-based caregiver-training program model and routine care model for dementia elders in Taiwan.

The illness course and symptoms of dementia is usually very long and characterized with behavioral, psychological and physical changes. Family caregivers' stresses change during the illness trajectory as well. Thus, the needs of the elderly persons with dementia and their family caregivers differ in different stage of dementia, and the services they require are multidimensional. According to the researchers' previous 2-year study, behavioral problem management and service utilization were found to be the most difficult and least prepared caregiving activities and the family caregiver's needs for assistance of these two caregiving activities differed in different stage of dementia.The purpose of this study is to compare the costs and effectiveness of two care models- home-based caregiver-training program model and routine care model for dementia elders in Taiwan.

Eligibility Criteria:
Inclusion Criteria:(patients)

* diagnosed with dementia by a psychiatrist or neurologist
* Age 65 years or older
* living in a community of northern Taiwan
* living in a home setting
* scored \>50 on the Chinese version Cohen-Mansfield Agitation Inventory (CMAI).

Exclusion Criteria:(patients)

* diagnosed with critical illness.

Inclusion Criteria:(caregivers)

* Primary caregiving responsibility and be at least 20 years old.

Exclusion Criteria:(caregivers)

* diagnosed with critical illness.
Personalized Care Pathways for Bowel Symptoms in Rectal Cancer Patients_contributing Factors (Treatable)

Colorectal cancer is the 2nd and 3rd most common cancer in respectively women and men, of which about 40% is located in the rectum. The gold standard treatment for rectal cancer (RC) is a low anterior resection, combined with chemoradiotherapy. However, this treatment will negatively impact different aspects of bowel function and the patients' quality of life. These bowel symptoms often remain prevalent, even at 12 months after RC treatment.

The aim of this study is to identify the factors contributing to persistent bowel symptoms and their long-term impact on quality of life following treatment for rectal cancer 12 month post-surgery or post-stoma closure. These insights are crucial in developing an effective care approach, as they assist us in determining when specific evaluations should be conducted and which treatments should be applied at different stages.


Eligibility Criteria:
Inclusion Criteria:

* Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures.
* At least 18 years of age at the time of signing the Informed Consent Form (ICF).
* Proficient in reading, comprehending, and conversing in Dutch.
* Patients scheduled for Total Mesorectal Excision (TME) or Partial Mesorectal Excision (PME) or 'Watch and wait' protocol due to rectal cancer.

Exclusion Criteria:

* The participant has undergone a different type of surgery, including a Hartmann procedure, abdominoperineal excision, transanal endoscopic microsurgery, or sigmoid resection.
* Experienced fecal incontinence prior to undergoing surgery.
* Are affected by neurological disorders affecting bowel function.
* Already underwent previous pelvic surgery, previous pelvic radiation or rectal surgery for non-cancer reasons.
* Has a permanent stoma.
HealthCall-S: A Pilot Study Targeting Concurrent Non-injection Drug Use and Alcohol in HIV Primary Care Clinics

This pilot study goal is to compare two different treatments to help HIV positive patients reduce their concurrent drinking and non-injection drug use.

The goal of this study is to compare the effects of brief motivational interviewing with participation in HealthCall to brief motivational interviewing alone on non-injection drug and alcohol use. HealthCall involves 2-3 minutes of daily smartphone use to track drug use, drinking behaviors and other aspects of health, followed by personalized feedback in a graph after 30 and 60 days of using the smartphone.

Eligibility Criteria:
Inclusion Criteria:

Age 18 and older; 2. During the prior 30 days, \> 4 days of non-injection of cocaine, methamphetamine or heroin, one of which is identified by the patient as his/her primary drug During prior 30 days, \> 1 day of binge drinking (\>4 drinks on one occasion); Completion of medically supervised detoxification if such detoxification is required; HIV Positive ; Able to give informed consent

Exclusion Criteria:

Patient is currently psychotic, suicidal, or homicidal. Patient has injected any drug in the last 6 months Patient has definite plans to leave the greater New York metropolitan area within the study period.

Patient has gross cognitive/psychomotor impairment as evidenced on the Halstead-Reitan Trails (A+B) Patient does not speak English or Spanish Patient has a hearing and/or vision impairment that precludes smartphone use.

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