cyrilzakka/clinical-trials huggingface dataset:
Edoxaban Treatment in Routine Clinical Practice in Patients With Venous Thromboembolism in Korea and Taiwan (ETNA-VTE-KOR-TWN)

According to current guidelines, duration of anticoagulant treatment after a venous thromboembolic event varies from 3 months to indefinite treatment depending on the estimated risks of venous thromboembolism (VTE) recurrence and bleeding. Current data for edoxaban are limited to a maximum treatment duration of 12 months.

Therefore, this study aims to gather further insight into efficacy (i.e. symptomatic recurrent VTE) and safety (i.e. bleeding events, liver adverse events, all-cause mortality and other drug related adverse events) of extended treatment with edoxaban up to 12 months in an unselected patient population in routine clinical practice.

Edoxaban is an orally administered anticoagulant that inhibits coagulation factor Xa. It has been approved by the Ministry of Food and Drug Safety (MFDS) in Korea (date: 25th, August 2015) for the: Reduction in the risk of stroke and systemic embolism in patients with non valvular atrial fibrillation (NVAF) Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) Reduction in the risk of recurrent DVT and PE, and by Taiwan Food and Drug Administration (TFDA) in Taiwan (date: 24th, February, 2016) for the Prevention of stroke and systemic embolism in adult patients with NVAF with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischemic attack (TIA). Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) following 5 to 10 days of initial therapy with a parenteral anticoagulant.

According to current guidelines, duration of anticoagulant treatment after a venous thromboembolic event varies from 3 months to indefinite treatment depending on the estimated risks of venous thromboembolism (VTE) recurrence and bleeding. Current data for edoxaban are limited to a maximum treatment duration of 12 months.

This non-interventional study aims to gather further insight into efficacy (i.e. symptomatic recurrent VTE) and safety (i.e. bleeding events, liver adverse events, all-cause mortality and other drug related adverse events) of extended treatment with edoxaban up to 12 months in approximately 350 patients in an unselected patient population in routine clinical practice.

Eligibility Criteria:
Inclusion Criteria:

* Established acute initial or recurrent VTE
* Patients prescribed treatment with edoxaban according to package information before participation in the trial
* Written informed consent for participation in the study (ICF)
* Not simultaneously participating in any interventional study

Exclusion Criteria:

* None
A Prospective Real-World Multi-Center Post-Market Observational Evaluation of Supersaturated O2 Therapy Using the TherOx® Downstream® System

The purpose of this study is to collect real-world data on the TherOx DownStream System® to assess the effectiveness and cost- effectiveness of SSO2 Therapy, compared with PCI alone for treatment of patients with acute anterior MI.


Eligibility Criteria:
Inclusion Criteria:

1. Men or women aged 18 years or older.
2. Presentation with anterior acute ST-elevation myocardial infarction (\> 1 mm ST-segment elevation in two or more contiguous leads between V1 and V4).
3. The primary stented infarct-related lesion(s) must be in the proximal and/or mid-LAD coronary artery (other lesions may be treated if clinically indicated).
4. Successful angioplasty within 6 hours of symptom onset, as documented by \<50% diameter residual angiographic stenosis within all treated culprit lesions with TIMI 2 or 3 flow and no major complications such as perforation or shock.
5. The patient or their legally authorized representative has been informed of the nature of the study, agrees to its provisions and has been provided and signed written informed consent, approved by the appropriate Institutional Review Board (IRB).
6. Patient and his/her physician agree to all required follow-up procedures and visits.

Exclusion Criteria:

1. Ipsilateral insertion of a second sheath in a single femoral artery for SuperSaturated Oxygen Therapy is strictly contraindicated.
2. Presence of an intra-aortic balloon pump.
3. Proximal coronary stenosis that would restrict flow with the SSO2 Catheter in place
4. Presence of a post-intervention non-stented coronary dissection or perforation.
5. Cardiac valvular stenosis or insufficiency, pericardial disease or non-ischemic cardiomyopathy.
6. Pregnant or nursing women.
7. Cardiogenic shock.
8. Patients contraindicated for anticoagulation therapy.
9. Patients with ventricular pseudoaneurysm, VSD, or severe mitral valve regurgitation (with or without papillary muscle rupture).
10. Hemoglobin \< 10 g/dL.
11. Gastrointestinal or genitourinary bleeding within the last two months, or any major surgery (including CABG) within six weeks of procedure.
12. Patients with active COVID-19 infection.
Targeting Infant Development With Early Screening

The purpose of this study is to assess feasibility and acceptability of parent-completed screeners of child social/emotional development, social determinants of health, and adverse childhood experiences in the setting of a pediatrics primary care clinic.

Local pediatric primary care practices are beginning to implement universal screening. The investigators plan to assess feasibility and acceptability of screening by querying parents of children in order to determine their expectations, perceptions, and opinions about the screeners. The investigators will also use data from electronic health records to examine the impact of screeners on referrals and healthcare utilization. The investigators will be examining screening rates and outcomes, and correlations with demographics and changes over time.

Eligibility Criteria:
Inclusion for general practice retrospective reviews:

* Seen for a well child check at Duke Children's Primary Care Roxboro Road.
* Age 0 to 4 at day of visit

Inclusion for targeted retro reviews:

* Seen for well check at Duke Children's Primary Care Roxboro Road
* Determined by HealthySteps to require Tier 2 or Tier 3 behavioral support services
* Age 0 to 4 at day of visit
A Study of Auxora in Patients With Critical COVID-19 Pneumonia

This is a single-blind study consisting of up to 3 cohorts Patients will be randomized 3:1 to Auxora or Placebo. The first 4 patients will be enrolled in Cohort 1. If dose escalation occurs, the next 4 patients will be enrolled in Cohort 2 If dose escalation occurs, the next 8 patients will be enrolled in Cohort 3. The decision to escalate dosing will be made by CalciMedica in consultation with the PI and after the review of safety events in Cohorts 1 and 2.


Eligibility Criteria:
Inclusion Criteria:

1. Has laboratory-confirmed SARS-CoV-2 infection as determined by polymerase chain reaction (PCR) or other commercial or public health assay in any specimen;
2. Moderate ARDS characterized by the following criteria:

   * Invasive mechanical ventilation with a minimum PEEP of 5 cm H2O;
   * PaO2/FiO2 ≤200 that may be estimated from pulse oximetry or determined by arterial blood gas;
   * No evidence of volume overload or heart failure;
3. The patient is ≥18 years of age at the time of consent;
4. QTcF interval ≤ 440 milliseconds;
5. A female patient of childbearing potential must not attempt to become pregnant for 39 months, and if sexually active with a male partner, is willing to practice acceptable methods of birth control for 39 months after the last dose of study drug;
6. A male patient who is sexually active with a female partner of childbearing potential is willing to practice acceptable methods of birth control for 39 months after the last dose of study drug. A male patient must not donate sperm for 39 months;
7. The patient is willing and able to, or has a legal authorized representative (LAR) who is willing and able to, provide informed consent to participate, and to cooperate with all aspects of the protocol.

Exclusion Criteria:

1. Expected survival or time to withdrawal of life-sustaining treatments expected to be \<7 days.
2. ECMO;
3. Suspected septic shock;
4. The patient has a history of:

   * Organ or hematologic transplant;
   * HIV;
   * Active hepatitis B or hepatitis C infection;
5. Current treatment with:

   * Chemotherapy;
   * Immunosuppressive medications or immunotherapy (see Section 5.3 for list of prohibited immunosuppressive medications and immunotherapy) at the time of consent;
   * Hemodialysis or Peritoneal Dialysis;
6. The patient is known to be pregnant or is nursing;
7. Currently participating in another study of an investigational drug or therapeutic medical device at the time of consent;
8. Allergy to eggs or any of the excipients in study drug.
A Prospective Multicenters Clinical Cohort Study of Stratified Treatment of Chinese Children With LBL

With the development of molecular biology and precise medical treatment, new challenges have been raised in the diagnosis and treatment of non-Hodgkin lymphoma (NHL) in children. In recent years, the criteria for clinical staging and efficacy evaluation of NHL in children have been updated. Recent clinical studies of COG in the United States and LMB in France have confirmed that molecular biological markers such as Notch1, PTEN and LOH6q are significantly associated with the prognosis of T-lymphoblastic lymphoma (T-LBL). These molecular biological markers should be included in the new risk stratification system. High-intensity treatment of high-risk patients will improve survival. Recent studies have also suggested that PET/CT is helpful in evaluating residual lesions in patients with lymphoma after chemotherapy. In order to keep pace with the times in the diagnosis, clinical staging, risk stratification, efficacy evaluation and treatment of NHL in children. SCCCG-LBL-2017 was formulated by South China Children's Cancer Group of Non-Hodgkin lymphoma, which mainly updated in clinical staging, efficacy evaluation, risk stratification, treatment,etc..

Research purpose:

1. To investigate the efficacy and safety of SCCCG-LBL-2017 in Chinese children with LBL.
2. To explore the feasibility of risk stratification of T-LBL by combining genotyping.
3. To investigate the correlation between MDD and MRD in lymphoblastic lymphoma and prognosis.
4. To investigate the role of PET/CT in the assessment of residual lymphoblastic lymphoma.
5. To explore the effect of reducing HD-MTX dosage and shortening maintenance therapy time on the efficacy and survival of low-risk LBL patients.
6. To explore the effect of prolonging the duration of maintenance therapy on the efficacy and survival of high-risk LBL patients.

Eligibility Criteria:
Inclusion Criteria:

1. Age \< 18 years old
2. Pathologically confirmed lymphoblastic lymphoma
3. Newly diagnosed patients
4. Informed consent of guardian of children patients -

Exclusion Criteria:

1. Age \> 18 years old
2. Recurrent lymphoblastic lymphoma
3. Secondary immunodeficiency.
Pain-related Long Covid in Covid-19 Survivors

The exploratory project aims to investigate the presence of pain as a long Covid-19 symptom in previously hospitalised patients and in non-hospitalised persons previously tested positive in a PCR test.

The main objectives investigated will be to determine the general prevalence of pain symptoms In Covid-19 survivors, correlating and analysing the role of previously comorbidities in the development of pain symptom in Covid-19 survivors, and to understand the prevalence of pain related long Covid-19 symptoms for future characterisations. Hence, the projects main outcome will be to try to understand why som Covid-19 survivors develop persistant pain and others don't. Furthermore, the project plan to analyse gender and age differences, and data between Covid-19 waves as well as any possible association between pain prevalence and time after positive PCR-test.

Eligibility Criteria:
Inclusion Criteria:

* Previously infected with SARS-CoV-2 virus

Exclusion Criteria:

* Participants under the age of 18
* Hidden/secret address/name
* No access to digital mail (the channel of data collection)
Interventional Clinical Trial for CCSVI in Multiple Sclerosis Patients

To investigate the safety and tolerability of balloon venoplasty compared to sham in Multiple Sclerosis patients with Chronic Cerebrospinal Venous Insufficiency (CCSVI) as measured by adverse events occurring within 48 weeks of the procedure.

Overview of study objectives are:

* To determine the safety and tolerability of venoplasty of CCSVI in Multiple Sclerosis (MS).
* To determine the short term and long term impact on validated patient measures and by physician and radiologic reported MS outcomes.
* To determine the short term and long term recurrence rate of CCSVI for veins that have been treated with venoplasty

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Relapsing Remitting Multiple Sclerosis (RRMS) or Secondary Progressive MS according to the McDonald criteria 2010
* Age 18 to 65 years inclusive
* Neurostatus (EDSS) score at screening from 0 to 6.5
* Fulfill ultrasound criteria for CCSVI

Exclusion Criteria:

* Previous venoplasty and/or stenting of extra cranial venous system
Potential Vertebroplasty Use in the Treatment of Vertebral Metastasis From Breast and Prostate Cancer

The study aims to evaluate if adding vertebroplasty to radiotherapy, in the treatment of spine metastasis from breast and prostate cancer, is preferable to radiotherapy alone. The investigators hypothesize that, by combining vertebral augmentation with cement and radiotherapy, they could achieve an enhancement in pain relief and level of activities, as well as a decrease in the side effects of multiple medications used for pain control.

Included patients presenting with spinal metastasis secondary to breast or prostate cancer are randomized to two groups, intervention and control. Both groups receive standard radiotherapy, which is currently the gold standard of care for such patients. The intervention group will also receive a vertebroplasty \[single or multiple level(s)\], while the control group will receive a simulated vertebroplasty, where local anesthesia and gentle hand manipulation will be used but the vertebra will not be accessed. The primary outcome is pain relief, though other factors such as quality of life and pain medications will also be evaluated.

There will be an interim analysis after half of the patients have been treated with a follow-up of 3 months. In the analysis, comparisons will be made between the two groups and each patient's individual progress will also be analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Between 35 and 75 years old
* Biopsy-proven breast cancer (BC) or prostate cancer (PC)
* Radiographic evidence of spine metastases from the BC or PC in the lumbar and/or mid-low thoracic spine
* Microfractures or compression fractures up to 40% of the original height of the vertebral body in an MRI \[magnetic resonance imaging\] (reported by an independent radiologist)
* Incidental back pain (Verbal Analog Scale \> 5/10) felt to be related to those metastases

Exclusion Criteria:

* Spinal cord compression
* Massive rupture of the posterior wall of the vertebral body (according to blinded radiological report)
* Coagulopathy (International Normalized Ratio \[INR\] \> 1.5, platelets \< 80,000)
* Inability to communicate in English, French or Spanish
* Previous radiotherapy to the spine in the area presently affected
* Mental cognitive impairment
* Vertebral metastasis without fracture in the MRI
The Healthy Child Development Program Study

This study conducts a preliminary test of an intervention program delivered in the home to assist families of preschool-age children with social, emotional, and behavioral development, and the acquisition of healthy lifestyle behaviors.

Utilizing referrals from community-based organizations serving high-risk families, this study addresses both health and behavioral domains through a family-based intervention. The home-delivered prevention intervention includes content on strengthening positive behaviors in children, managing misbehavior, and addressing healthy lifestyle choices. Families engage in practical skill building and have the opportunity to practice these skills and receive feedback.

Eligibility Criteria:
Inclusion Criteria:

* parent has primary custody of the child
* one or more children in the home is in the 3 to 4 year old age range
* English-speaking parent
* parent stated an interest to participate in the program
* parent completes informed consent process
* family experiencing economic disadvantage
* parenting challenges due to child behavior

Exclusion Criteria:

* an open Child Protective Services maltreatment case on the family
* parent receiving inpatient treatment or enrolled in an institutional-residential treatment program
18F-Fluorocholine Positron Emission Tomography (PET) for the Detection of Parathyroid Adenomas

This is a prospective single arm single center Phase III study evaluating the ability of 18F-fluorocholine to detect the location of parathyroid adenomas.

PRIMARY OBJECTIVE:

I. To investigate the performance (accuracy) of 18F-fluorocholine PET in the detection of hyperfunctioning parathyroid glands in surgical patients with biochemically proven primary hyperparathyroidism.

OUTLINE:

Participants will receive a single dose of 18F-Fluorocholine at the time the participant undergoes a single imaging study using 18F-fluorocholine. Study related procedures will end after the study visit. Participants who undergo subsequent parathyroidectomy, will have the results reviewed and compared to the results from the imaging study

Eligibility Criteria:
Inclusion Criteria:

* Age \>= 13 years.
* Biochemically proven hyperparathyroidism and an indication for surgery.
* Ability to understand a written informed consent document, and the willingness to sign it.

Exclusion Criteria:

* Current Pregnancy.
* Patients unlikely to comply with study procedures, restrictions and requirements and judged by the Investigator to be unsuitable for study participation.
Thai MSM/TG Test and Treat Study

Objectives

1. To determine the uptake of universal HIV testing among Thai men who have sex with men (MSM) and transgender women (TG)
2. To determine the uptake of antiretroviral treatment (ART) regardless of CD4 count among Thai MSM/TG who test positive for HIV

Subject population:. Men or transgender women who have sex with men,Thai nationals, age ≥18 years old, Have engaged in anal intercourse with a man without using a condom at least one time in the last 6 months or have had at least 3 male sex partners in the last 6 months,Not known to be HIV-positive (either have never been tested for HIV or have had a previous negative HIV test)

Number of participants:2000 Thai MSM and TG with approximately 76%-90% in Bangkok, 5%-12% in Lampang and 5-12% in Ubonratchathani.

All participants will receive HIV testing at baseline. The frequency of study visits to determine HIV status in HIV-negative participants will be every 6 months for a total follow up time of 24 months. Once HIV-positive status is confirmed, participants will be offered ART immediately regardless of CD4 count. Those who accept ART will be seen more frequently following ART initiation, at 2 weeks, 4 weeks, 2 months, 3 months and every 3 months thereafter until completion of 24 months of follow-up. Those who deny immediate ART will have clinic visits every 6 months to monitor HIV disease. HIV-negative participants will be asked to come for HIV re-testing every 6 months or sooner if they feel exposed to risk

Eligibility Criteria:
Inclusion Criteria:

1. Thai nationals
2. Age \>18 years
3. Men or transgender women who have sex with men
4. Have engaged in anal intercourse with a man without using a condom at least one time in the last 6 months or have had at least 3 male sex partners in the last 6 months
5. Not known to be HIV-positive (either have never been tested for HIV or have had a previous negative HIV test)
6. Have signed the consent form

Exclusion Criteria:

1. Known HIV-positive serostatus
24-hour Ambulatory Blood Pressure Monitoring in Patients With Blood Pressure Above Thresholds in General Practice

High blood pressure (HBP) is a major modifiable cardiovascular risk factor which prevalence is gradually increasing. Reducing blood pressure (BP) significantly decreases cardiovascular morbi-mortality. Nevertheless, BP control remains insufficient: only 51% of French patients using antihypertensive drugs achieve the BP control targets.

HBP is mostly diagnosed and managed in primary care. Nevertheless, office BP measurements are unreliable for BP control and poorer predict target organ damage. Ambulatory BP measurements are recommended for HBP diagnosis and follow-up. 24-hour ambulatory blood pressure monitoring (ABPM) is the most cost-effective strategy. Its superiority has been demonstrated for HBP diagnosis and cardiovascular prognosis.

In France, ABPM is poorly available and little studied in primary care. Therefore, the investigators conducted a regional prospective study to analyze the feasibility and benefits of ABPM among primary care hypertensive patients in daily practice.


Eligibility Criteria:
Inclusion criteria:

* patients aged over 18 years
* with an office inclusion consultation systolic/diastolic BP≥ 140/90 mmHg
* able to understand French language and to consent to participate in the study

Exclusion criteria:

* patients aged \< 18 years
* with conditions preventing technically adequate ABPM (chronic atrial fibrillation)
* with contraindications to ABPM (musculotendinous disease of the upper limb, past history of phlebitis of the upper limb or phlebitis in progress, past history of olecranon bursitis or bursitis in progress)
* with previous ABPM in the 12 months prior to the inclusion consultation
* pregnant or lactating women