cyrilzakka/clinical-trials huggingface dataset:
Implementing a Tool to Identify Risk for Venous Thromboembolism in Cancer Patients

Cancer increases the risk of deep vein blood clots and clots traveling to the lungs (emboli) which cause morbidity (leg swelling, pain, and shortness of breath), sudden death, delays cancer treatment, and decreases cancer survival by 66% compared to similar cancer patients without blood clots. Blood thinners may prevent clots but major bleeding is also a problem, so preventive therapies are not used routinely. Identifying patients at highest risk for clots is critical. A tool exists but it has not been used outside of research. We propose to study how to apply this tool in clinical practice and test if it works.

Patients with Cancer have a risk for venous thromboembolism (VTE) including deep-vein thrombosis (DVT) and/or pulmonary embolism (PE) that is markedly higher than non-Cancer patients. An acute episode of VTE has deleterious effects on the quality of life and long-term survival of cancer patients. Cancer patients with VTE have survival rates that are only one third of otherwise identical patients without VTE. Once VTE is diagnosed over 10% of cancer patients suffer a further event while on standard therapy and over 5% suffer a major hemorrhagic event.

The best way to treat VTE is its prevention (thromboprophylaxis). Studies suggest that among ambulatory cancer patients, risk for VTE varies markedly between patients and that the lack of knowledge of this risk, delays diagnosis and hampers efforts to effectively prevent VTE. Therefore, the identification of patients at high-risk for VTE may enable faster diagnosis of VTE and better use of thromboprophylaxis.

Recent studies have developed a novel tool to stratify VTE risk in cancer patients before they initiate anti-cancer treatment. We hypothesized that this risk tool will accurately identify cancer patients at high-risk and that its implementation in our clinical practice will result in a faster clinical diagnosis of VTE.

Our objective is: a) to evaluate the ideal strategy to incorporate the tool in our clinical setting as seamlessly as possible, and b) to determine whether the tool accurately predicts risk and results in a faster investigation for VTE.

Patient eligibility will be determined during the patient's initial consult to the Ottawa Cancer Center after cancer diagnosis has been confirmed by the medical Oncologist and before initiation of anticancer treatment. Follow-up for this study will be for 12 months and patients will be seen at the time of scheduled appointments for cancer treatment.

Eligibility Criteria:
Inclusion Criteria:

* 18 years old or older
* with a newly diagnosed cancer site (brain, bladder, lung, testicle, pancreas, stomach and lymphomas)
* or progression of the malignant disease after complete or partial remission who have not recently received chemotherapy (≤ 3 months), radiotherapy and surgery (≤ 2 weeks)

Exclusion Criteria:

* Cancer patients with confirmed VTE or arterial embolism within the last 3 months
* Cancer patients who are receiving continuous anticoagulation
SAPHNELO Systemic Lupus Erythematosus Japan Post-Marketing Surveillance (PMS)

To collect information on and evaluate the long-term safety and effectiveness of Anifrolumab in patients with systemic lupus erythematosus in the real-world post-marketing setting.

The objective of the Specific Use Result Study is to collect information on and evaluate the long-term safety and effectiveness of Anifrolumab in patients with systemic lupus erythematosus insufficiently responding to currently available treatment in the real-world post-marketing setting.

This investigation will be conducted to support the application for re-examination specified in Article 14-4 of the Pharmaceutical Affairs Law.

Eligibility Criteria:
Inclusion Criteria:

patients with systemic lupus erythematosus insufficiently responding to currently available treatment -

Exclusion Criteria:

None

-
Trial of Vitamins in HIV Progression and Transmission

This study tested the hypothesis that multivitamin supplementation given to HIV+ pregnant women in Tanzania would slow disease progression and enhance their overall health.

In this study, we sought to examine whether the administration of multivitamins excluding vitamin A, multivitamins including vitamin A, or vitamin A alone would reduce the risk of perinatal transmission of HIV and slow the rate of disease progression in a group of pregnant HIV infected women. We also examined the efficacy of the supplements on pregnancy outcomes, and risks of maternal and child morbidity and wasting.

Eligibility Criteria:
Inclusion Criteria:

* HIV-infected women presenting to antenatal care between 12 and 27 weeks of gestation:

Exclusion Criteria:

-
Active and Passive Distraction in Children Undergoing Wound Dressings

The hypothesis was that an active distraction is more effective than a passive distraction in conjunction with procedural pain in children. The specific aim in this study was to test how an active distraction, serious gaming and a passive distraction, the use of lollipops influence pain, distress and anxiety in children during wound care.


Eligibility Criteria:
Inclusion Criteria:

Children aged five to twelve were recruited from the pediatric day care unit at the Queen Silvia Children's hospital, Gothenburg, Sweden. Included children had wounds that differed in size and location but were too extensive to be handled in a primary care setting. The wound dressing procedures were standardized and the pain experiences were expected to be similar in all included children.

Exclusion Criteria:

Children with longstanding wounds, care-related pressure wounds, and wounds in body areas with decreased sensitivity were excluded from this study.Children with cognitive impairments were excluded from the study, as were children or parents who did not have a good command of Swedish.
Sedentary Intervention Trial in Cardiac Rehabilitation

Exercise-based cardiac rehabilitation (CR) has been shown to consistently reduce the rates of total and cardiovascular-related mortality and morbidity. Sedentary behaviours have been shown to be high in patients with cardiovascular disease, but it is not yet known if current CR programming results in significant reductions in these behaviours, or whether a targeted component is warranted. It is also unclear if self-reported sedentary time measures can provide valid and reliable information for monitoring these behaviours in a CR setting, or whether more objective measures are needed. The purpose of this study is to assess the feasibility and usability of the activPAL3 devices for measuring sedentary time in a CR setting, describe changes in sedentary time that occur with standard CR and assess whether the addition of prompting cues from a device can result in further declines in sedentary behaviour and improvements in clinical outcomes, health related quality of life, symptoms of anxiety and depression, aortic stiffness, and aerobic capacity.


Eligibility Criteria:
Inclusion Criteria:

* Patient is attending on-site (2 times weekly for 8 weeks) cardiac rehabilitation at the Minto Prevention and Rehabilitation Centre at the University of Ottawa Heart Institute
* Patient is 18 years of age or older
* Patient has confirmed diagnosis of coronary artery disease (CAD)
* Patient understands English or French
* Patient is willing and able to provide informed consent

Exclusion Criteria:

* Patient is unwilling to wear activity monitors
* Patient is already using a commercial activity monitor with sedentary prompts (e.g. Jump Up, Garmin)
* Patient is unable to attend follow-up visits
* Patient not participating in a cardiac rehabilitation program at the University of Ottawa Heart Institute
* Patient has cognitive impairment (unable to comprehend or participate in the intervention)
* Patient has a history of postural hypotension
* Patient is unable, in the opinion of the Medical Director, to participate in the study.
Trial Comparing Oral Pilocarpine (Salagen) Versus Submandibular Salivary Gland Transfer Protocol, For the Prevention of Radiation (XRT) Induced Xerostomia in Head and Neck Cancer Patients

This is a study to see whether the drug Salagen or salivary gland transfer is better for the prevention of dryness of the mouth in patients with head and neck cancer receiving radiation treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Previously untreated and confirmed histological diagnosis of squamous cell/adenoid cystic carcinoma of the oropharynx, hypopharynx, larynx, and patients with unknown primary tumor with metastases to the neck nodes and squamous cell carcinoma of the skin of head and neck region with ipsilateral neck nodes (more than one node) metastases.
2. Radiation volume to encompass \> or equal to 80% of major salivary glands (parotids and the non-transferred submandibular salivary gland) and have \> or equal to 50 Gys delivered to that volume via external beam.
3. Karnofsky performance score \> or equal to 70
4. Minimum age 18 years
5. The patient must sign a study-specific informed consent prior to study entry
6. Expected survival \> or equal to one year

Exclusion Criteria:

1. Carcinoma of nasopharynx, oral cavity, N3 disease, bilateral neck node involvement, pre-epiglottic space involvement, involvement of level 1 nodes on either side of the neck, and patients with post-operative recurrent disease.
2. Salivary gland malignancy
3. Salivary gland disease
4. Use of anti-cholinergic drugs and tricyclic drugs
5. Delay in XRT of more than 8 weeks following the curative surgery
6. Pregnant or lactating females are not eligible. Patients of childbearing potential should agree to use an effective method of contraception
7. Prior head and neck irradiation
8. Recurrent disease
9. Allergy to pilocarpine
10. Patients with uncontrolled asthma, acute iritis, or narrow angle glaucoma
Effectiveness of a School Wellbeing Programme for Internalising Problems in Irish Primary School Children

The aim of this study is to assess the effectiveness of a school-based multi-component universal programme for the reduction of internalising problems (i.e. anxiety and low mood) in primary school pupils.

Childhood and adolescence are important developmental phases for wellbeing and mental health. School has been noted in psychological literature to be a favourable environment for mental health initiatives, such as school-based programmes. Universal programmes are programmes delivered to all pupils irrespective of perceived need and have several advantages, including having a wide reach, avoiding the need for screening and are less stigmatising.

A Lust for Life is a universal school-based multi-component intervention whose target is to build well-being and emotional resilience in children. The programme was informed by evidence-based psychological approaches including cognitive behaviour therapy, positive psychology and mindfulness and consists of six lessons, each delivered by the pupils' school teacher on a weekly basis. The lessons involve classroom discussions, videos, classroom activities and homework assignments.

Study participants will complete the Revised Children's Anxiety and Depression Scale Short Format, Coping strategy indicator and Self-Efficacy Questionnaire for Children pre-intervention. Following this, schools randomly assigned to the experimental group will receive A Lust for Life, while those randomly assigned to the control group will be placed on a sixteen-week waiting list. The questionnaire measures and a Brief Satisfaction Scale will be completed by participants at post-intervention. In addition, a six-week follow-up assessment will determine whether the effects of the programme are sustained over a period of time. The programme will be delivered in the waiting list control group schools after the six-week follow-up assessment.

Eligibility Criteria:
Inclusion Criteria:

* Child
* Enrolled in primary school in Ireland
* Obtain written informed consent from parents/guardians
* Provide written assent

Exclusion Criteria:

* Failure to meet inclusion criteria
Efficacy and Safety Study on Nasogastric (NG) Tube in Patients With Upper Gastrointestinal Bleed

Upper gastrointestinal tract hemorrhage (UGIH) remains a major cause of morbidity and mortality . Nasogastric aspiration (NGA) is routinely performed in patients with UGIH to obtain important clinical data and make therapeutic decisions. But routine use of NGA remains controversial with studies reporting its usefulness and its redundant clinical information. Early esophagogastroduodenoscopy (EGD) is recommended by most gastrointestinal societies to allow for risk stratification and to perform endoscopic treatments. The results of the NGA may assist to differentiate between high-risk versus low-risk lesions. Our hypothesis is that presence of NGA can identify lesions that require endoscopic treatment and provides important clinical information to guide the treating physician. In addition, we hypothesized that the results of the NGA influence the clinical decision of the treating physician regarding the prediction of the need for endoscopic therapy. This observational randomized cross-sectional study will enroll consecutive patients with presumed UGIH and randomized them to NGA and no NGA recording its results. All patients will receive an EGD and its results will also be recorded. Subsequently, we will evaluate if the NGA is important in identifying endoscopically significant lesions. The information gained will help guide clinicians evaluating patient with UGIH.


Eligibility Criteria:
Inclusion Criteria:

* Patients older then 21 years-old presenting with actual or reported: Hematemesis, Melena, or Hematemesis and Melena

Exclusion Criteria:

* Refusal to participate
* Severe comorbid conditions making EGD hazardous for the patient, such as myocardial infarction \< 3 months with the exception if the myocardial infarction was caused by the UGIH, hemorrhagic or ischemic stroke \< 3 months, decompensated congestive heart failure, severe respiratory failure unless the patient is already intubated
* Survival expected to be less than 72h as judged by treating clinician
* Prisoners
* Patient with severe mental illness precluding the ability to obtain informed consent
* Ongoing anticoagulation which can not be reversed secondary to patient safety
* Strongly suspected gastrointestinal perforation
* Recent endoscopy (less than 30 days)
Genetesis Accelerated Registry

Heart disease is the number one cause of death in the United States, with over 650,000 deaths in 2019 alone. Many healthy individuals possess key risk factors for heart disease which include but are not limited to high blood pressure, high cholesterol, family history of heart disease, and diabetes. The purpose of the Genetesis Accelerated Registry (GEAR) study is to understand the potential for magnetocardiography to be utilized as a diagnostic, screening or surveillance tool for heart disease in healthy and non-healthy volunteers. Magnetocardiography (MCG) is a diagnostic method that analyzes and records the magnetic fields of the heart for the detection of various forms of heart disease. There will be a 12-month duration of the study where we propose to collect screening data from approximately 500 volunteers who present to the Genetesis facility for a 5-minute CardioFlux MCG scan. The volunteers will be contacted at intervals over a 1-year period for follow-up data and may choose whether or not they would like to provide follow-up data or participate in another scan.


Eligibility Criteria:
Inclusion Criteria:

1. ≥ 18 years of age at the time of enrollment.

Exclusion Criteria:

1. \< 18 years of age
2. Patients unable to fit into device
3. Non-ambulatory patients
4. Patients with present with or have reasonable clinical suspicion of any acute coronary syndrome for which delayed intervention could increase the risk or magnitude of damaged myocardium
5. Patients with claustrophobia or unable to lie supine for 5 minutes
6. Pregnant women
7. Poor candidate for follow-up (e.g. no access to phone)
8. Prisoners
9. Patients with a language barrier/language difficulties
Accuracy Evaluation of the BD FACS Presto System

The enumeration of T lymphocytes positive for the CD4 antigen is used to determine the immune status of patients with, or suspected of developing, immune deficiencies such as AIDS. The BD FACS Presto™ is an investigational automated system for in vitro diagnostic use in performing the direct enumeration of CD4 absolute count, CD4 percentage of lymphocytes, and hemoglobin (Hb) concentration in human whole blood.

This is a prospective study to determine the relative bias between the investigational BD FACS Presto system and the predicate BD FACS Calibur with BD Tritest system in their determination of absolute CD4, % CD4, and Hb concentrations.


Eligibility Criteria:
Inclusion Criteria:

* Subject has been infected with HIV and willing to provide informed consent to draw venous and capillary blood
* Specimen: Venous blood must be collected in blood collection tube with EDTA anticoagulant and stored at room temperature (20-25 °C) according to tube manufacturer's instructions
* Specimen: post enrolment staining within 24 hours
* venous blood of acceptable quality for flow cytometry, e.g. no hemolysis or clots and acceptable pre analytical handling)
* venous blood sample \> 1 mL for sample preparation
* capillary blood applied to the investigational CD4/%CD4/Hb cartridge

Exclusion Criteria:

* Subject unwilling to disclose medical information regarding previous CD4 test results
* Subject unwilling to discuss medical information regarding co-morbid conditions and current medications
BRAVO - Betrixaban Registry Using Real Time Observations in Acute Medical Illness to Assess Venous Thrombosis and Bleeding Outcomes

Part 1 - Evaluate the real-world implementation of extended prophylaxis with betrixaban in the acutely ill hospitalized medical population Part 2 - Describe patterns of Venous thromboembolism (VTE) prophylaxis in acutely ill medical patients who qualify for extended VTE prophylaxis


Eligibility Criteria:
Inclusion Criteria:

-Part 1 -

1. Hospitalized acutely ill medical patient
2. Patient prescribed betrixaban
3. Signed informed consent

Part 2 -

1. Hospitalized acutely ill medical patient
2. Patient prescribed betrixaban OR must satisfy criteria a and b:

   1. Moderately or severely restricted immobility: patient restricted to bed for at least 24 hours (severe) or restricted to bed for at least 12 hours (moderate) during their hospitalization
   2. At least One additional risk factor:

Age \> 70 years D-dimer \> 2x institutional Upper Limit of Normal (ULN) Obesity: Body mass index (BMI) \> 30 kg/m2) History of pulmonary embolism (PE) or deep venous thrombosis (DVT) Active cancer (diagnosed, treated, or progressing in the past 6 months) History of thrombophilia Recent trauma or surgery (within 30 days prior to admission) Ongoing hormonal treatment ICU stay 3. Signed informed consent

Exclusion Criteria:

* Part 1 - 1. High bleeding risk - any of the following:

  1. Patient on dialysis
  2. Low platelet count (\<50 per 109/L)
  3. Known bleeding disorder (congenital or acquired)
  4. Liver disease prohibitive to anticoagulation
  5. Bleeding within last 30 days
  6. Use of Dual Anti-Platelet Therapy (DAPT)

Part 2

1. Patients who are on another oral anticoagulant (OAC) for any reason at the time of hospitalization and will remain on it
2. Condition requiring use of OAC at admission, other than VTE prophylaxis (eg, acute VTE at admission)
3. High bleeding risk any of the following:

   1. Patient on dialysis
   2. Low platelet count (\<50 per 109/L)
   3. Known bleeding disorder (congenital or acquired)
   4. Liver disease prohibitive to anticoagulation
   5. Bleeding within last 30 days
   6. Use of Dual Anti-Platelet Therapy (DAPT)
Implementation and Effectiveness of "CareAide® App" for People with Cardiometabolic Diseases At a Primary Care Clinic

This study aims to explore the barriers and facilitators to implement CareAide® app among healthcare providers and patients at a primary care clinic in Malaysia.

This is an implementation-qualitative research study meaning researchers will collect data regarding the adoption rate, ease of implementation and adoption, and patient's willingness to use the application. The researchers will also compare the effectiveness of the application as a tool to remind patients to take their medicine, by comparing between a group of participants who use the app and another group of participants who do not use the app.

This study requires participants to use an app, then attend some routine follow-ups and be administered blood tests, followed by an interview to collect their opinions, feelings, and experiences.


Eligibility Criteria:
Inclusion Criteria:

* Above 18 years old
* Medically diagnosed with either hypertension, type 2 diabetes and dyslipidemia for at least 6 months as listed in electronic health records
* Exhibit a low adherence indicated by Malaysia Medication Adherence Assessment Tool (MyMAAT) scores of \<54 scores
* Taking at least one type of medication daily, three medications daily or two medications with multiple dosing intervals prescribed,
* Owns and able to use a smartphone
* Able to read English or Malay

Exclusion Criteria:

* Individuals who are pregnant, already using any adherence apps or diagnosed with any terminal illnesses, visually impaired, disability or mental health related illnesses
Local Recurrence Prediction of by Texture Analysis Derived From Positron Emission Tomography (PET / CT) Imaging of Non-small Cell Lung Cancer (NSCLC) Treated With Stereotactic Radiotherapy (SBRT) (Retros MUMOFRAT)

The aim of this retrospective multicentric study was to develop and evaluate a prognostic FDG PET/CT radiomics signature in early-stage non-small cell lung cancer (NSCLC) patients treated with stereotactic radiotherapy (SBRT).


Eligibility Criteria:
Inclusion Criteria:

* NSCLC stage I-II treated by SBRT
* PET/CT imaging performed within 60 days of SBRT

Exclusion Criteria:

* Lack of follow-up
* Refusal of consent
Attention Bias Modification Treatment for Children With Social Anxiety

Children with social anxiety will be randomly assigned to either Attention Bias Modification Treatment (ABMT) designed to direct attention away from threat or a placebo control condition not designed to change attention patterns. Outcome measures will be depression and social anxiety symptoms as measured by gold standard questionnaires as well as diagnosis of social phobia disorder and symptom counts derived from structured clinical interviews with children and their parents.

We expect to see significant reduction in social anxiety symptoms in the Attention Bias Modification Treatment (ABMT) group relative to the placebo control group.


Eligibility Criteria:
Inclusion Criteria:

* children suffering from social anxiety

Exclusion Criteria:

* Pharmacological or Psychological treatment