cyrilzakka/clinical-trials huggingface dataset:
Assessment of the Efficacy of the First Aspirin Dose in Children Undergoing Surgery for Congenital Heart Disease (CHD) Who Require Post-operative Antiplatelet Therapy

The use of heparin and aspirin for their respective anticoagulation and antiplatelet effects is routine in intensive care units around the country and world in children who have undergone surgery for congenital heart disease (CHD) who are at risk for thrombosis after repair. Most common protocols recommend heparin infusions after surgery with transition to oral aspirin when oral intake begins. Patients at risk for thrombosis after congenital heart surgery requiring long-term antiplatelet therapy include those undergoing shunt placement for single-ventricle palliation or establishment of pulmonary blood flow, valve replacements, or coronary artery manipulation. Post-operative thrombosis after congenital heart surgery is rare, but thrombosis can result in death. The routine use of aspirin in these patients is intended to prevent the potentially catastrophic consequences of thrombosis. However, there is no routine clinical assessment of the platelet inhibitory effect of aspirin; nor have there been any prospective studies to assess the effectiveness of aspirin's antiplatelet effect in children after congenital heart surgery. No data exists to suggest that the first dose of aspirin transition from heparin infusion is either sufficient or insufficient in its antiplatelet effect.

In this study, the investigators will evaluate the effectiveness of the first aspirin dose in its antiplatelet effects after surgery for congenital heart disease. Degree of antiplatelet effect will be evaluated with thromboelastograph (TEG) and TEG-platelet mapping study analysis. Thromboelastography is a clinical laboratory method of assessing whole blood hemostasis and allows for assessment of clot formation, strength, and stability. TEG is most commonly used in patients at risk for bleeding or thrombosis and also to monitor antiplatelet therapies (such as aspirin).

The investigators hypothesize: the first dose of aspirin transitioned from heparin infusion after congenital heart surgery is sufficient in its antiplatelet effect as tested by TEG and TEG-platelet mapping studies. Confirmation of the antiplatelet effect of aspirin will help support the current practice of empiric aspirin therapy to prevent post-operative thrombosis in children after congenital heart surgery.


Eligibility Criteria:
Inclusion Criteria:

* Age 0-18
* Undergoing surgery for congenital heart disease requiring oral antiplatelet therapy

Exclusion Criteria:

* Strict: personal or family history of bleeding/clotting disorder, patients requiring anticoagulation rather than antiplatelet therapy after surgery.
* Relative: patients with significant post-operative bleeding precluding the use of anticoagulation and/or antiplatelet therapy within the first 48-72 hours (eg. clinical instability preventing the initiation of oral aspirin therapy), patients requiring additional fresh platelet transfusion after the initiation of post-operative heparin infusion.
Ultrasound Guided Erector Spinae Plane Block Versus Retrolaminar Plane Block

Retrolaminar block (RLB) and erector spinae plane block (ESPB) are alternative approaches to paravertebral block (PVB) and are advantageous in that they are easier and safer techniques compared with the traditional PVB. These blocks are considered to be compartment blocks or interfascial plane blocks. In these approaches, local anesthetics are assumed to penetrate the superior costotransverse ligament and reach the paravertebral space, although the needle tip is not advanced into the paravertebral space.

the study aim to evaluate and compare the analgesic efficacy of retrolaminar plane block and erector spinae plane block.


Eligibility Criteria:
Inclusion Criteria:

1. Age18-60.
2. Both genders.
3. hepatobiliary surgery.
4. ASA I-III.

Exclusion Criteria:

1. Drug allergy.
2. Morbid obesity (BMI \>40 kg/m2).
3. Psychiatric disorder.
4. Opiod dependence.
Increasing Equity in Lung Cancer Screening

The overall objective of this mixed methods study is to: 1) Refine the Emergency Department Lung Cancer Screening (ED-LCS) intervention using qualitative interviews among key stakeholders; 2) pilot test the ED-LCS intervention evaluating the intervention efficacy, acceptability, and feasibility; and 3) provide an in-depth description of stakeholders' experiences with the ED-LCS intervention for future refinement.


Eligibility Criteria:
Inclusion Criteria:

* • Eligible for LCS (50-80 years old, smoked in past 15 years, and smoked at least 20 pack years)

Exclusion Criteria:

* • Non-English/Spanish speaking

  * Decompensated psychiatric illness (suicidal, homicidal, psychosis). Will confirm with attending physicians at time of enrollment
  * Intoxicated with alcohol or drugs
  * Cannot provide reliable follow up contact information (cell phone)
  * Presenting to the ED with a life-threatening condition
  * Have received chest CT scan in past 12 months
  * Already enrolled in LCS
  * Hospice enrolled
Aortic Valve replAcement in eLective Patients From aOrtic Valve multiceNter Registry

Multicenter registry data analysis of aortic valve stenosis patients that underwent elective, isolated transcutaneous aortic valve implantation (TAVI) or surgical aortic valve replacement between 2015 and 2019. In TAVI group only transfemoral access was considered.

A retrospective analysis of the Multicenter Aortic Valve Registry patients operated between 2015 and 2019 in the three departments of cardiac surgery in Poland: the Medical University of Silesia in Katowice, Medical University in Gdańsk, and Poznań, University of Medical Science. Baseline clinical, procedural, and outcome data at follow-up were entered into prespecified electronic case report forms. Follow-up status was validated by personal contact or access to Polish National Health Fund. Patients with planned concomitant intervention on coronary arteries (by bypass grafting or percutaneous intervention), other valvular interventions, arrhythmia ablation, or left atrial appendage occlusion were excluded too. In TAVI group only femoral access was considered. For SAVR any tissue or mechanical valve implantation in an aortic position with sternotomy or minimal access was included.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* Elective procedure
* Aortic valve replacement with means of TAVI or SAVR

Exclusion Criteria:

* Concomitant procedures
Project Engage: A Wrist Biosensor-based mHealth Suite to Support Alcohol Intervention in Young People Living With HIV

In this study, participants will be asked to wear a wrist alcohol biosensor for 30 days and report alcohol use using a ecological momentary assessment (EMA) app. A subset of the sample will be micro-randomized to test two engagement strategies--reciprocity and personalized feedback via the eWrapper app to promote their engagement with the biosensor.

YPLWH (N = 160, 136 after 15% attrition, 18-29 years of age, estimated to include 73% male, 26% female, 1% transgender, 70% racial and ethnic minorities) will be asked to wear a wrist alcohol biosensor (BACtrack Skyn) for 30 days and report their alcohol use using daily ecological momentary assessment (EMA). A subset of the sample will also be micro-randomized twice daily to test two empirically-based engagement strategies - reciprocity and personalized feedback. Data from the 30-day MRT will be used to (a) develop and validate the algorithm for alcohol detection based on Skyn data; and (b) address scientific questions concerning which engagement strategy works best, for whom and under what conditions in terms of facilitating proximal engagement in biosensor wearing. We will also collect alcohol biomarker (i.e., PEth) at 1-month follow up.

Eligibility Criteria:
Inclusion Criteria:

* 18 years and 0 months to 29 years and 11 months
* Currently reside in Florida
* Report having had at least 1 alcoholic drink in the last 30 days
* Able to read and understand English
* Have internet access via smartphone, tablet or computer
* Be diagnosed as HIV positive and;
* Willing to provide informed consent.

Exclusion Criteria:

* Adults unable to consent
* Individuals who are not yet adults
* Individuals who are not diagnosed as HIV+
* Prisoners
* Pregnant women
Nursing Activity and Quality of Hospitalized Patients' Sleep

This study is to determine the impact of night shift nurse's activity on patients' sleeping patterns in medical services including individual, clinical and environmental factors. The patients will be questioned in order to create both a control group and a group with troubled sleeping patterns.

There are 5 speciality medical units involved. Patients must respond to the define inclusion criteria. Each patient will be asked if they agree to participate and if so will be asked to consent to participate.

Every day, nurses will give a questionnaire which will be completed by the patient to know if there were troubles sleeping patterns. If so, a second questionnaire will be completed by the patient.

Other data will be recorded such as personal informations, diagnostic, medical history, consumption habits and treatments.

The inclusion phase lasts 15 days maximum.

Eligibility Criteria:
Inclusion Criteria:

* Patient hospitalize in medical units
* In the unit since one night
* Patient over 18 years old
* Patient agree to participate

Exclusion Criteria:

* Patient who can't answer to the questionnaire for health reasons
* Patient who need a specific surveillance
* Patient recently operated
Balance Systems Protocol for Subacute Phase Stroke Patients.

The aim of the study is to evaluate if the application of a protocol focused on the equilibrium systems versus the conventional treatments decreases the time to acquire equilibrium in standing, the risk of falls and favors the early initiation of treatments aimed at recovering the physiological gait.

In order to respond to the objectives, a randomized clinical trial was proposed on a total N of 70 stroke survivors (N = 35 patients in the control group and N = 35 patients in the intervention group), who Are in the subacute stage of the disease, meet the inclusion and exclusion criteria, and require hospitalization to perform the rehabilitative treatment.

For this, a rehabilitation treatment protocol was designed focusing on the equilibrium systems. The intervention of the study will be carried out during 4 weeks. The control group will receive conventional rehabilitation treatment for stroke patients, consisting of physiotherapy therapy for 60 minutes; While the intervention group will receive conventional rehabilitative treatment during the first 45 minutes and the last 15 minutes therapy will be based on the protocol designed.

The evaluation of the program will be carried out based on the stated objectives. In order to evaluate the improvement of the patients in terms of balance, gait, risk of falls and patient autonomy, these will be assessed at the beginning of the intervention at 15 days and at the end (30 days). After the intervention two more assessments will be made; At 3 months and at 6 months to follow up in time.

Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 18 years, who are admitted to an intermediate care unit after an acute stroke, for functional recovery.
* Diagnosis of ischemic or hemorrhagic stroke confirmed by Magnetic Resonance Imaging (MRI) or Computed Tomography (CT) scan.
* Patients with no alteration on sitting balance: patients should be able to sit on the edge of the bed with the hip and knees on 90º flexion, feet flat on the floor and inclination forward 30º towards the healthy and paretic side and able to return to the vertical balance without any support of the back or upper limbs.

Exclusion Criteria:

* Patients with severe prior functional dependence (Barthel Index ≤60)
* Patients diagnosed with dementia or previous cognitive impairment
* Patients diagnosed with delirium.
* Patients diagnosed with Wernicke aphasia.
* Patients with previous visual deficit (retinopathy, cataract, etc.)
* Patient with a history of other causes of balance impairment.
* Patients with orthopedic conditions that difficult the performance of the proposed rehabilitation treatment.
Efficacy and Safety of Basiliximab in Hepatitis C Virus Positive Patients Undergoing Liver Transplantation

The natural history of HCV infection in liver transplant recipients may be accelerated when compared to that in patients with normal immune systems.

The objective of this trial is to assess the efficacy and safety of basiliximab, in combination with cyclosporin and MMF on the success rate of liver transplants for HCV related cirrhosis, in comparison with standard steroid treatment.


Eligibility Criteria:
Inclusion Criteria Patients undergoing first cadaver liver transplant Patients receiving an AB0 identical or compatible graft HCV+ patients (serology test within the last 12 months)

Exclusion Criteria Antiretroviral prophylactic treatment post-transplant Serological markers positive for Hepatitis B surface Antigen and Human Immunodeficiency Virus Recipients of a split liver transplant Other protocol-defined inclusion/exclusion criteria applied
Study of the Efficacy and Safety of Letrozole Combined With Trastuzumab in Patients With Metastatic Breast Cancer

Phase IV trial to investigate the effect of the combination of Letrozole with trastuzumab in metastatic breast cancer patients


Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal
* Her-2 overexpression and ER and/or PgR positive
* Metastatic Breast Cancer

Exclusion Criteria:

* Previous treatment with trastuzumab
* Significant Liver or renal impairment
* Erbb2 negative and/or ER and PgR negative

Other protocol-defined inclusion / exclusion criteria may apply.
Etanercept Treatment in the Early Course of Polymyalgia Rheumatica

The purpose of this study is to evaluate the effect of the tumor necrosis factor alpha (TNF) antagonist, etanercept, on the early clinical course of polymyalgia rheumatica (PMR).

PMR is a common inflammatory disease with an unknown etiology that is characterized by aching, tender, and stiff proximal muscle. Some evidence suggests that TNF plays a central role in the pathophysiology of PMR.

The preferred treatment with glucocorticoids (GCs) is adequate for most patients, but a subset of patients have a more prolonged, relapsing disease course. These patients require treatment with GCs for 1 to 2 years. GC related adverse events are frequent during treatment.


Eligibility Criteria:
Inclusion Criteria:

* Persons with active polymyalgia rheumatica (patients only).
* Signed informed consent and written authorization.

Exclusion Criteria:

* Other inflammatory conditions than polymyalgia rheumatica, including symptoms of giant cell arteritis, e.g. head aches, jaw claudication and visual disturbances.
* Current malignancy or history of malignancy.
* Neuromuscular conditions.
* Infections with systemic impact.
* Uncontrolled diabetes mellitus.
* Uncontrolled hypertension.
* Current tuberculosis or history of tuberculosis.
* Severe heart failure (NYHA class 3 and 4).
* Current use of glucocorticoids, biological drugs, and immunosuppressive drugs.

Exclusion Criteria (controls):

* Polymyalgia rheumatica.
Comparison of Tumor Glucose Metabolism Before and After Artificial Nutrition

Evaluate the feasability to determine the difference of tumoral metabolism before and after artificial nutrition.

Evaluation of the feasability to determine the difference of tumoral metabolism before and after artificial nutrition. This activity will be measured with TEP/TDM 18F-FDG

Eligibility Criteria:
Inclusion Criteria:

* VADS cancer or oesophageal cancer
* Evaluation by 18F-FDG PET
* denutrition with weight loss of 5%
* Artificial nutrition
* ECOG\<2

Exclusion Criteria:

* Treatment by chemotherapy, surgery unless 2 months
* Treatment by radiotherapy unless 4 months
* Capillar glycemia \>12mmol/l during the PET
The Effect of Two Short Education Programs for Nonspecific Low Back Pain in a Workers' Health Care Organization

The purpose of this study is to assess the effect of two different types of health education programs on the disability, beliefs related to low back pain and duration of sick leave in patients seen at a workers' health care organization


Eligibility Criteria:
Inclusion Criteria:

* low back pain patients, with or without referred or radiated pain
* no systemic disease or criteria for referral to surgery

Exclusion Criteria:

* inability to fill out the questionnaires and scales
* bedridden
* rheumatologic inflammatory disease, cancer or fibromyalgia
* suspicion of fibromyalgia
* spinal fracture
Evaluate the Efficacy of Anti-Jak1 Inhibitors as Treatment for Patients With Aicardi-Goutières Syndrome

Aicardi-Goutières Syndrome (AGS) is a hereditary multisystem autoinflammatory disorder that predominantly affects the central nervous system. It is characterized by severe neurological disability and chronic inflammation caused by the persistent overproduction of type I interferon. To date, nine causative genes of AGS have been identified, each of which can lead to classic AGS presentations, atypical forms, or other manifestations that do not meet the formal diagnostic criteria for AGS and are referred to as "AGS-related interferonopathies." Janus Kinase 1 (JAK1) inhibitors, including Baricitinib and Ruxolitinib, offer a promising therapeutic strategy for Aicardi-Goutières Syndrome (AGS) by directly targeting the central pathogenic pathway of the disease.

Patients treated with JAK1 inhibitors for AGS have shown significant improvement in systemic symptoms, though the effect on neurological symptoms and brain imaging remains unclear.

The aim of this project is to retrospectively analyze the efficacy, particularly on neurological symptoms and brain imaging, and the safety of JAK1 inhibitor treatment in AGS patients treated at Italian tertiary centers. Data will be collected before starting the therapy and during follow-up at 6, 12, 18, and 24 months, where available.

Preliminary data collection was carried out through a survey conducted by the AGS Italy group to assess the number of patients treated with JAK1 inhibitors.

Clinical, brain imaging, genetic, and laboratory data routinely recorded in nine different Italian centers as part of the standard clinical care of these patients will be retrospectively collected and analyzed.

In the second phase of the study, brain MRI data from AGS patients treated with JAK1 inhibitors will be compared to untreated AGS patients matched for age and genotype, in order to evaluate the potential therapeutic efficacy of JAK1 inhibitors on brain imaging compared to the natural clinical progression of the disease.

Through the analysis of the Italian experience, this study could lay the groundwork for drafting a potential consensus on the use of JAK1 inhibitors for the treatment of AGS patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 0 to 25 years
* Patients who have been genetically diagnosed with Aicardi-Goutières Syndrome (AGS) or AGS-related interferonopathies For case cohort-Patients treated with Janus Kinase 1/2 (JAK1/2) inhibitors, such as Baricitinib or Ruxolitinib

Exclusion Criteria:

* Patients over the age of 25 years
* Patients who have not been genetically diagnosed with Aicardi-Goutières Syndrome (AGS) or AGS-related interferonopathies.
Assessment of Changes in Labioincisal Relationship in Deep Bite Correction by Twin Slot Orthodontic Bracket Clinical Trial Study.

Assessment Changes in Labio incisal Relationship in Deep bite Correction by Twin Slot Orthodontic Bracket; clinical trial study.

Group(A): patients will be treated with double slot bracket with wire in incisal slot Group(B):patients will be treated with double slot bracket with wire in cervical slot

Eligibility Criteria:
Inclusion Criteria:

* • Mild to moderate deep bite.

  * Permanent dentition stage (excluding the third molar)
  * Age ranges from 16-23 years.
  * Free from any medical or systemic condition that could interfere with
  * Orthodontic treatment plane or effect on procedures. Angle class1 or class11 malocclusion with minimal crowding.
  * Female patient to avoide any sexual dimorphism which may affect the comparison.
  * Good oral hygiene.
  * No previous orthodontic treatment.

Exclusion Criteria:

* Uncooperative patient.

  * Frequent missing appointments.
  * Frequent broken appliance.
  * Previous orthodontic treatments.
  * Any systemic or bone diseases.
Safety and Tolerability of IRX-101 in Patients Receiving Intravitreal Injections

This is a randomized, double-masked study to evaluate the tolerability and safety of IRX-101 versus 5% povidone-iodine (PI) in subjects receiving intravitreal anti-VEGF injections.


Eligibility Criteria:
Inclusion Criteria:

1. Capable of giving informed consent
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Male or female, ≥ 18 years of age and receiving intravitreal anti-VEGF injections in one or both eyes

Exclusion Criteria:

1. Current or past diagnosis of endophthalmitis
2. Current diagnosis of uveitis
3. Monocular patients (vision 20/100 or worse in one eye) who are receiving injections in the better seeing eye
4. Current use of viscous lidocaine products for ocular anesthesia prior to IVT
5. Currently receiving intravitreal steroid injections
6. Concurrent participation in another clinical trial
7. Females who are pregnant, planning to become pregnant or lactating
Lavender vs Zolpidem Sleep Quality During Diagnostic PSG

In this pragmatic, clinical study the investigators propose that lavender aromatherapy is comparable to Zolpidem (Ambien) in improving the quality of diagnostic sleep studies.


Eligibility Criteria:
Inclusion Criteria:

* Age \>=18 years
* In-center diagnostic or split night sleep study (PSG)

Exclusion Criteria:

* No exclusion criteria
The Nanowear Wearable Covid-19 Observational and Analysis Trend

The NanoCOAT study is a multi-center, prospective, non-randomized, feasibility, observational, non-significant risk study. The NanoCOAT study will enroll a minimum of 10 and a maximum of 100 subjects in a potential for a multi-site in order to collect data and analyze physiological and biometric trends due to Covid-19.


Eligibility Criteria:
Inclusion Criteria:

* Subject has provided informed consent
* Male or female over the age of 18 years
* The patient is currently hospitalized with a primary diagnosis of Covid-19

Exclusion Criteria:

* Subject is unwilling or unable to wear the vest during hospitalization.
* Subjects who are pregnant.
* Subject is intubated or admitted to ICU
* Subject has an implantable cardiac device (i.e pacemaker or internal cardioverter defibrillator)
RCT of Post-Suicide Attempt Case Management (ACTION-J)

This study will determine the effectiveness of continuous follow-up care by case manager in preventing further suicide attempts

It is well known that many subjects who survived a suicide attempt will make further suicide attempts, even after the medical treatment at critical emergency unit. To examine the effectiveness of continuous follow-up care by case manager after the suicide attempt, a randomized, controlled, multicenter trial by J-MISP (Japanese Multimodal Intervention Trials).This research project is one of the strategic research projects funded by The Japanese Ministry of Health, Labor and Welfare. In this study, J-MISP will implement the intervention for suicide attempters, a considerably high-risk group of further suicide attempts, who are transported by emergency services.

Eligibility Criteria:
Inclusion Criteria:

1. Over 20 years old
2. Suffering from Axis I disorder
3. Had intent for suicide (confirmed more than 2 times)
4. Able to understand this study and provide informed consent
5. Able to have interview before trial registry and psycho education at hospital
6. Able to have interview for assessment at continuous follow-up care by case manager at the hospital

Exclusion Criteria:

1. Not suffering from Axis I disorder as a primary diagnosis