cyrilzakka/clinical-trials huggingface dataset:
Role of the MSCT in Evaluation of the Congenital Cardiovascular Anomalies

Congenital heart diseases (CHDs) are considered as the most common congenital birth defects, comprising 1% of all live births . Echocardiography remains a first-line non-invasive imaging tool for establishing the diagnosis and follow-up in most patients .This method is operator dependent and limited by an acoustic window .

Traditional angiography is typically utilized as the gold standard modality for diagnosing CHD, but it is an invasive method and need general anseathsia with dose of radiation exposure .After recent developments in CT and MR technologies, cardiac catheterization is no longer necessary for diagnosis .

The interpretation of cardiovascular structures on cardiac CT scan studies is similar to that for echocardiography, however, it is not limited by the acoustic window or operator dependent like ultrasonography. In addition to the anatomic information, a cardiac CT scan provides hemodynamic information, including extracardiac and intra-cardiac shunts. It also enables the systematic evaluation of other thoracic structures like cardiovascular structures, the airways and the lungs by using maximum and minimum intensity projections to delineate the vascular and airway structures, respectively. Extra-cardiac great vessels can be evaluated along their length; thus augmenting the role of cardiac CT scans in children with congenital heart diseases .Inspite of the poorer temporal resolution of cardiac CTA compared to echocardiography, yet the combination of rapid acquisition time, increased anatomic coverage, high spatial resolution, multiplanar reformation and 3D capability combined with a flexible ECG synchronization have improved the image quality of cardiac CT scans and minimizing the patient risks. Multidetector computed tomography has greatly advanced the noninvasive diagnosis of these anomalies in pediatric patient, thus makes MDCT an ideal non- invasive method for evaluating pediatric patients .

Eligibility Criteria:
Inclusion Criteria:

* patients suffering from congenital cardiovascular diseases diagnosed either clinically or by echocardiographic examination.

Exclusion Criteria:

* orthopenic patient patients with hypersensitivity to contrast , medium and poor renal function .
Prospective, Non-interventional, Multi-center Post-authorization Safety Study of Riociguat for Chronic Thromboembolic Pulmonary Hypertension (CTEPH )

This local, prospective, non-interventional, multi-center study includes patients treated with Riociguat for inoperable CTEPH(Chronic thromboembolic pulmonary hypertension)/ persistent or recurrent CTEPH after surgical treatment. It is planned to include a total of 400 patients (valid for safety analysis). This study is performed as an all-case investigation. The treatment of Riociguat is performed based on the product label in Japan. The standard observation period is 12 months from the 1st treatment of Riociguat. Safety and effectiveness are evaluated at 4th and 12th month. In addition, the extension observation is carried out once a year for 7 years at the longest to collect information on safety and effectiveness as long as Riociguat treatment continues. When the treatment of Riociguat is terminated, observation of a patient ends. For each patient, the investigator records data as defined in the protocol at each evaluation point by using the Electronic Data Capture (EDC) system. The duration of the study is approximately 9 years from launch.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are treated with Riociguat for CTEPH

Exclusion Criteria:

* Patients who are contraindicated based on the product label
A Pilot Study of Thrombin Generation Changes in Neonates Undergoing Placement of a Blalock-Taussig Shunt

The primary goal of this investigation is to describe perioperative thrombin generation in neonates undergoing placement of a Blalock-Taussig (BT) shunt to better understand the coagulation changes that precipitate postoperative shunt occlusion.

To accomplish our goal, the investigators will measure preoperative levels of one major procoagulant (prothrombin) and one major anticoagulant (Antithrombin). The investigators will also measure preoperative and postoperative thrombelastograms (TEG) and preoperative and postoperative thrombin generation curves (TGC).

Eligibility Criteria:
Inclusion Criteria:

1. Full-term neonates (37-42 weeks gestational age)
2. Apgar score of 7 or more at 5 minutes after delivery
3. Surgical placement of BT shunt or repair of an aortic coarctation
4. Parent or legal guardian willing to participate, and able to understand and sign the provided informed consent

Exclusion Criteria:

1. Preterm neonates (less than 37 weeks gestation)
2. Apgar score of less than 7 at 5 minutes after birth
3. Emergent procedure
4. Surgical procedure other than placement of BT shunt or repair of aortic coarctation
5. Neonates with a known coagulation defect or coagulopathy
6. Mother with a known coagulation defect or coagulopathy
7. Parent or legal guardian unwilling to participate or unable to understand and sign the provided informed consent
Anal HSIL Screening Algorithm

This the propose to use the Multiphase Optimization Strategy Trial (MOST) design to identify an anal HSIL screening algorithm which is most suitable in terms of effectiveness, efficiency, and economy. Specifically, The Investigators will use a factorial design as the main strategy in the MOST, as this allows the evaluation of multiple intervention components that are candidates for ultimate inclusion in the algorithm. The Investigators will then implement the most suitable anal HSIL screening algorithm in the clinic, using the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) framework to guide its design, implementation, and evaluation. An interrupted time series will be used to compare anal HSIL screening uptake among men who have sex with men clients in the clinic, prior to and after the implementation of the new anal HSIL screening algorithm, and mixed-methods approaches will be used to evaluate components of the RE-AIM framework.

I. PREPARATION PHASE Purpose To lay groundwork for optimization of anal high-grade squamous intraepithelial lesion screening algorithm for MSM, and identify which test and component(s) should be included in the anal HSIL screening algorithm.

II. OPTIMIZATION PHASE Purpose To form an anal high-grade squamous intraepithelial lesion screening algorithm that meets the optimization criteria.

III. EVALUATION PHASE Purpose To establish whether the optimized anal high-grade squamous intraepithelial lesion screening algorithm has a statistically significant effect on service uptake among MSM compared to the standard of care.

Eligibility Criteria:
Inclusion criteria

Clients for MSM and TGW:

* Thai nationality, men with self-identifies as MSM and/or TGW
* HIV-positive MSM/TGW aged 30 years or older or
* HIV-negative MSM/TGW aged 40 years or older

Clinic staff:

- Has worked in the study clinic during phase III

Government stakeholders:

- Involved in health policy development in Thailand

Exclusion criteria

Clients for MSM and TGW:

* Unable to perform any study procedures, or unable to commit to attend all study visits.
* Had Anal cancer lesion at enrollment visit, this exclusion for participation in phase II study.

Clinic staff:

- Not willing to participate in the evaluation

Government stakeholders:

- Not willing to participate in the evaluation
Study of the Repair of Flexor Tendons of the Hand

Injury to the flexor tendons of the fingers of the hand is a frequent and disabling injury, since it produces tendon retraction and functional limitation. A prompt and adequate diagnosis and treatment is required to minimize the risk of tendon retraction, re-rupture, reoperation rate, and the presence of tendon adhesions that limit the range of motion. On occasions, the limitation of the articular balance of the MCP, PIP and DIP joints generates a loss of strength and difficult in completely closing the fingers to the palm of the hand.

To retrospectively evaluate the results obtained with the suture/ reinsertion of the flexor tendons of the hand, in the acute, subacute and chronic phases, treated surgically in our center between the years 2000 and 2021.

To evaluate the clinical and functional results obtained in patients who underwent surgery for a section of the flexor tendons, superficial, profundus or both, preferably in zone II of the hand. The investigators evaluate the epidemiological and prognostic factors associated with the injury, in the different phases and anatomical zones.

The researchers evaluate the functional results:

Pain at rest with movements: Assessed using the visual analogue pain scale (VAS Scale from 0 to 10).

Joint balance / Range of motion of the MCP, PIP, DIP joints. Evaluation by digital goniometer. Evaluation using Buck-Gramcko (1976) and using the Tang (2007) criteria.

Grip strength. Evaluation using a Jamar dynamometer. Functional rating scales: QuickDASH Score Reoperation rate: 1) For re-rupture / re-suture, 2) For infection, 3) For excision of tendon adhesions: arthrolysis and tendolysis, 4) For tendon transfer 5) For tendon graft placement.

Eligibility Criteria:
Inclusion Criteria:

* Patients with section of the superficial and / or profundus flexor tendons in the hand.
* Patients with section of the flexor tendon in the thumb
* Tendon injury in any anatomical area
* In the acute, subacute or chronic phases of the disease
* Associated or not with fractures
* Associated or not with arterial or nerve injuries

Exclusion Criteria:

* Previous bone disease
* History of tendon injury to the extensor or flexor tendons
* Joint stiffness prior to tendon section
* Rheumatic arthropathy
* History of operations in the same area.
Treatment of Macular Edema Caused by Leber's Miliary Aneurysms Using Intravitreal Aflibercept and Peripheral Laser Photocoagulation

This study evaluates the effectiveness of intravitreal Aflibercept (IVA) injection therapy, combined with peripheral laser photocoagulation, in the treatment of macular edema caused by Leber's miliary aneurysm. We believe that our study makes a significant contribution to the literature because to our knowledge, it is the first to report cases, in which IVA injection therapy was used to treat this condition.


Eligibility Criteria:
Inclusion Criteria:

* FA revealed many aneurysms with leakage in the temporal mid-peripheral retina and near the macula. Optical coherence tomography (OCT) showed moderate to marked cystoid macular edema and subretinal fluid. There were no abnormal findings in the cornea, anterior chamber, or lens. No particular lesions were found in the opposite eye of each subject. Based on these findings, the patients were diagnosed with Leber's miliary aneurysm.

Exclusion Criteria:

-
Effect of Tertiary A-level Hospital Remote Intervention on MACCE, Adherence to Drugs and Risk Factors Control in Patients With Stable Coronary Artery Disease Compared With Traditional Community Hospital Follow-up

The study was a multicenter, two-arm, parallel, open label, prospective study intended for to compare effect of offline community hospital intervention on adherence to drugs and risk factors control in patients with stable coronary artery disease compared with tertiary A-level hospital WeChat-based intervention.

Objective: This study is intended for to compare effect of offline community hospital intervention on adherence to drugs and risk factors control in patients with stable coronary artery disease compared with tertiary A-level hospital WeChat-based intervention.

Study design: The study was a multicenter, two-arm, parallel, open label, prospective study that evaluated a WeChat-based intervention offered by tertiary A-level hospital with 1 year of follow-up.

Study intervention: All patients received lifestyle intervention and drug adjustment at 1 month, 3 months, 6 months and 1 year follow-up. In the control group, the subsequent visit was through an offline outpatient clinic at 4 different community hospitals. Participants in this group received standard outpatient cardiology follow-up with formal cardiac rehabilitation and secondary prevention. While in the intervention group, the subsequent visit was through WeChat-based online consultations.

Outcome measures: The primary outcome was MACCE. Secondary outcome included blood pressure, heart rates, smoking cessation, drinking cessation, body mass index, and medications adherence.

Statistical analysis: Values of analyzed endpoints between intervention group and control group will be compared according to the analysis plan. We'll follow a prespecified analysis plan and subgroup analysis will be conducted accordingly.

Eligibility Criteria:
Inclusion Criteria:

1. aged between 18-99 years
2. diagnosed with SCAD according to guidelines by coronary CTA or coronary angiography (including stable angina, ischemic cardiomyopathy, and the stable course after acute coronary syndrome)
3. have sufficient Chinese language proficiency to reading, speaking and listening
4. live with at least one caregiver or guardian in the household
5. presence of stable hemodynamics without using vasopressor
6. able to individually consent
7. not participating in any other clinical trial

Exclusion Criteria:

1. unable to provide informed consent
2. unable to be involved in clinical follow up and treatment
3. suffered comorbidity with a life expectancy of less than 1 year
4. have contra-indication to cardiac rehabilitation
5. acute coronary syndrome
Garlic in Hyperlipidemia Caused by HAART

The purpose of this study is to test the effectiveness and tolerability of garlic pills in lowering cholesterol and triglycerides in hyperlipidemic HIV-infected individuals who are being treated with highly active antiretroviral therapy (HAART).

Clinical evaluation of garlic in HIV disease is warranted for several reasons. First, garlic is used as a botanical medicine and as an alternative therapy by many HIV-infected individuals. Baseline data from the Bastyr's Alternative Medicine Care Outcomes in AIDS (AMCOA) study \[1\] indicate that garlic is the most frequently used botanical medicine among HIV-infected men and women (52.9%) who utilize complementary and alternative medicine (CAM). In the same cohort, 50% of the subjects who use antiretroviral therapy are also taking garlic supplements. Second, there is a growing body of studies that indicate that garlic exhibits lipid and glucose lowering as well as hepato-protective activities. Third, several of the pharmacological activities of garlic and their reported clinical benefits in other conditions, especially in hyperlipidemia, may be relevant in the management of highly active antiretroviral therapy (HAART) in HIV-infected subjects.

Study Medication: We will utilize GarlicinTM, an allicin-standardized dried garlic supplement in two escalating doses in HIV-infected subjects who are receiving HAART.

Eligibility Criteria:
Inclusion Criteria:

* HIV-1 seropositive confirmed by medical history
* On stable HAART for at least 6 months before study entry without the likelihood of HAART therapy changes in the following 6 months due to viral rebound or adverse events
* CD4+ lymphocyte number \> 100 cells/mm3 measured within 60 days before study entry
* HIV-1 viral load \< 2000 RNA copies/ml
* Cholesterol \> 200 mg/dL
* Triglycerides \> 250 mg/dL \< 1000 mg/dL
* Willing and able to avoid raw or dry garlic, onion, leeks and shallots as well as supplements containing garlic during the 16 weeks of the trial
* Willing and able to provide inform consent
* Willing and able to understand and follow protocol for the duration of the study
* Willing and able to maintain a consistent lifestyle routine, eg. diet, exercise, medications, dietary supplements and sleep schedule for the duration of the study
* Willing and able to understand and follow the Step 1 guidelines from the National Cholesterol Education Program (NCEP) for the duration of the study
* Willing to remain adherent to the current HAART regimen
Pilot Effectiveness Trial of an ACT Self-help Workbook Tailored Specifically for Prisons

The goal of this research study is to adapt an ACT-self-help workbook to the prison setting and determine the feasibility acceptability, and effectiveness of this workbook.

Participants can expect to be in the study for 13 weeks.

The Specific Aims of the proposed study correspond directly to the three-step process.

1. In Step 1 (Specific Aim #1), identify the necessary adaptations to the content, language, and format of an ACT-based self-help workbook through stakeholder input.
2. In Step 2 (Specific Aim #2), refine the workbook and its delivery based on feedback from incarcerated individuals who complete the workbook.
3. In Step 3 (Specific Aim #3), determine the feasibility, acceptability and preliminary effectiveness of the ACT self-help workbook in a prison setting. Primary clinical outcome measure will be depression, secondary clinical outcome measure will be anxiety.

For each participant assigned to a condition, a study team member will meet with them individually to provide them with a copy of the workbook. During this meeting, the study team member will inform the participant that they should complete one chapter per week.

Participants will complete a Pre-Treatment Assessment prior to distribution of the workbook; a Mid-Treatment Assessment four weeks after the distribution of the workbook; a Post-Treatment Assessment #1 eight weeks after distribution of the workbook (when the workbook should be completed); Focus group (after completion of workbook) and, a Post-Treatment Assessment #2 twelve weeks after distribution of the workbook.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Reading level of 6th grade or higher determined by the Wide Range Achievement Test
* Moderate or severe anxiety and/or depression determined by the Beck Depression Inventory-II (BDI-II) and Beck Anxiety Inventory (BAI)
* No active self-harm or active suicidal intent
* No scheduled transfer or release for at least three months
* Must be willing and able to participate, including having permission and ability to use study materials, such as paper and a writing utensil

Exclusion Criteria:

* Unable to provide informed consent
* Active self-harm or suicidal intent
* Scheduled transfer or release within three months
Support for Physical Activity in Everyday Life With Parkinson's Disease

This study aims to determine the effects of a motor-cognitive exercise intervention, delivered in the home environment using eHealth methods, among people with Parkinson's disease. The intervention will support and motivate motor training, combined with cognitive training, aimed at attentional and executive functions, among people at mild-moderate disease stages. The main hypothesis is that unsupervised motor-cognitive training in the home environment using eHealth will lead to improvements in gait performance, increased physical activity levels and improved perceived health.

This randomised controlled trial will investigate the efficacy of a motor-cognitive exercise program in the home environment, over a 10-week period, on physical function, and motor-cognitive dual task function as well as physical activity behavior in everyday life. Participants will be recruited through Stockholms sjukhem foundation, Karolinska University and via announcements in relevant forums like for instance the Swedish Parkinson Association. Consenting participants will be randomized to the eHealth Intervention group or the control group condition. Block randomization will be achieved using a computerized random sequence generator. Blinded assessors will perform the pre- and post-intervention testing of physical performance.

The ultimate aim of this project is to provide people with PD with continual long-term and evidence-based rehabilitation in their everyday lives using mobile health technology, to support their self- management and increase their quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of idiopathic Parkinson´s disease
* Hoehn \& Yahr (Parkinsons progression scale) 2-3
* ≥ 50 years of age
* Able to ambulate indoors without mobility aid
* Able to walk continually with/without a walking aid for at least 6 minutes

Exclusion Criteria:

* Cognitive impairment affecting the ability to understand or follow verbal or written instructions (Montreal Cognitive Assessment ≤ 21 points
* Major problems with freezing and/or two or more falls in the month previous to inclusion
* Other existing neurological/ orthopedic or cardiovascular disease which impedes the performance of unsupervised exercise
* Impaired vision and/or impaired communication which hinders participation
* No internet connection in the home
Longitudinal Morphometric Changes Following SCI

In patients with chronic spinal cord injury, imaging of the spinal cord and brain above the level of the lesion provides evidence of neural degeneration; however, the spatial and temporal patterns of progression and their relation to clinical outcomes are uncertain. New interventions targeting acute spinal cord injury have entered clinical trials but neuroimaging outcomes as responsive markers of treatment have yet to be established. We aim to use MRI to assess neuronal degeneration above and below the level of the lesion after acute spinal cord injury. In our prospective longitudinal study, we enroll patients with acute traumatic spinal cord injury and healthy controls. We assess patients clinically and by MRI at baseline, 2 months, 6 months, 12 months, and if possible 24 months and 60 months follow-up, and controls by MRI at the same timepoints. We assess cervical atrophy in white and gray matter and use cross-sectional spinal cord area measurements to assess atrophy at cervical level (C2/C3) and in the lumbar enlargement. We use myelinsensitive magnetisation transfer (MT) and longitudinal relaxation rate (R1) maps in the brain to assess microstructural changes associated with myelin. We also use diffusion tensor imaging acquired in the spinal cord at C2/C3 and in the lumbar enlargement to identify axonal loss and demyelination in the spinal white matter. Finally, we assess associations between MRI parameters and clinical improvement.


Eligibility Criteria:
Inclusion Criteria:

SCI patients:

* acute injury to the spinal cord
* no medical or mental illness
* written informed consent
* over the age of 18 years

Control subjects:

* over the age of 18 years
* written informed consent

Exclusion Criteria:

SCI patients:

* head or brain lesion associated with the trauma leading to the injury
* epileptic seizures
* MRI contraindications
* pregnant women or lactating women

Control subjects:

* pregnant women or lactating women
* MRI contraindications
* neurological or psychiatric illness