cyrilzakka/clinical-trials huggingface dataset:
Impact of Von Willebrand Factor and Its Multimers on Angiogenesis

The study aims to study the expression of numerous proteins involved in angiogenesis in 70 patients with von Willebrand disease in order to try to identify markers of interest. Secondly, the investigators plan to investigate whether there is a relationship between the proteins tested, the distribution of multimers and the clinical phenotype of the patients, in particular by looking for the presence of bleeding linked to the presence of angiodysplasias.


Eligibility Criteria:
Inclusion Criteria:

For patients:

* Patient with von Willebrand disease proven by genetic analysis of the VWF gene.
* Lack of treatment that could interfere with angiogenesis.
* Patient informed by an information note sent to his home, with the possibility of objecting to the use of his blood samples in the context of research.

For the control:

* Patient with a normal coagulation report
* Absence of abnormal hemorrhagic symptoms
* Lack of notion of angiodysplasia.
* Lack of treatment that could interfere with angiogenesis.
* Patient informed by an information note sent to his home, with the possibility of objecting to the use of his blood samples in the context of research.

Exclusion Criteria:

* Patient under guardianship or curatorship.
* Pregnant and lactating women.
* Blood transfusion or treatment with von Willebrand factor concentrates less than 7 days old.
* Treatment which may interfere with angiogenesis.
Observational Study of Baska Mask, a New Supraglottic Airway Device

The Baska mask is a new supraglottic airway device . The investigators would like to assess its performance in setting in which the current standard - LMA device - is being used.

Our group has performed a number of studies on novel airway devices. In this study we would like to evaluate a new supraglottic airway named Baska mask. We would like to monitor certain parameters (time to and ease of insertion, failure rate, seal pressures, complications etc) as regarding the performance and safety profile of this device. This is a descriptive case series of patients undergoing airway management under general anaesthesia.

Eligibility Criteria:
Inclusion Criteria:

* Written informed Consent
* No relevant drug allergies
* Body-mass index (BMI) 20-35
* Age 18-65
* Non-urgent surgery of planned duration 0-2 hrs

Exclusion Criteria:

* Inability of patient/parent to understand or consent for the trial
* Non-English speakers
* Neck pathology
* Previous or anticipated problems with the upper airway or upper GI tract (reflux, hiatus hernia, oropharyngeal tumour, upper respiratory tract infection in the last 10 days etc)
* BMI \>35
* Expected Difficult airway
* Live Pregnancy
* Increased risk for Gastric Aspiration
Evaluation of a Transdiagnostic Mobile App Intervention Among University Students

This study is a two-armed randomized controlled trial (RCT) aimed at evaluating the effectiveness and adoption of a transdiagnostic mobile app intervention that focuses is on enhancing adaptive emotional regulation (ER) skills among university students.

Globally, an estimated 30% of university students struggle with mental health issues, primarily anxiety, depression, and substance abuse. Recent trends have highlighted the potential of online interventions for accessible, low-threshold support in preventing these issues among this demographic.

At Erasmus University Rotterdam (EUR), a transdiagnostic mobile app is being developed as part of a student wellbeing program. This app provides a range of tools aimed at improving mental health by teaching students adaptive emotional regulation strategies. It incorporates exercises from various therapeutic modalities, addressing factors like negative thoughts, rumination, and prolonged negative emotions. Delivered through a smartphone, the app includes 24 therapeutic exercises focusing on techniques such as enhancing positive emotions, mindfulness, cognitive defusion, cognitive restructuring, relaxation, breathing, and self-compassion.

The present study is a 12-week two-armed RCT study with outcomes assessed at the baseline, and three follow-ups at weeks 3, 8, and 12. It compares a group of distressed students with access to the mobile app intervention against a waitlist control group.

The main goal of the study is to assess the impact of the intervention on stress symptoms and emotional regulation skills. The secondary outcomes of the study, include an evaluation of the intervention's impact on depression, anxiety symptoms, and students' resilience levels. Lastly, the study examines the app's uptake, including engagement patterns and user experiences, and evaluates the real-life application of the skills learned through the app.

Eligibility Criteria:
Inclusion Criteria:

* Willing to participate and provide informed consent
* Access to smartphone and internet
* Feels comfortable with English language for verbal and written communication and interaction with the app
* Scores \<13 on the Perceived Stress Scale (PSS-10)

Exclusion Criteria:

* Scores \>20 on the Patient Health Questionnaire (PHQ-9)
* Having a medical diagnosis of psychosis or bipolar disorder, severe clinical depression or anxiety disorder
* Undergoing psychopharmacological treatment or treatment with experimental drugs
A Research Study Looking Into Blood and Urine Levels of the Medicine NNC0194-0499 in the Body and How Well it is Tolerated in Participants With Reduced Kidney Function and Normal Kidney Function

Novo Nordisk is developing the study medicine NNC0194-0499 for the treatment of non-alcoholic steatohepatitis (NASH). NASH is a serious disease where fat, inflammation and scar tissue builds up in the liver. In this study the blood and urine levels of NNC0194-0499 will be compared in people with various degrees of reduced kidney function to the blood and urine levels in people with normal kidney function, after administration of one dose of 30 milligrams (mg) NNC0194-0499. Participant will only get the study medicine in one injection into a skinfold in the thigh (subcutaneous). The study will last for about 66 days including a screening phase of up to 28 days prior to dosing.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, aged 18-80 years (both inclusive) at the time of signing informed consent.
* Body mass index (BMI) between 18.5-39.9 kilogram per meter square (kg/m2) (both inclusive).
* Meeting the pre-defined estimated glomerular filtration rate (eGFR) values based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation according to Kidney Disease: Improving Global Outcomes (KDIGO) 20121, 2 standardized to the individual body surface area (BSA).

Group description eGFR (mL/min)

1. Normal renal function greater than or equal to 90
2. Mild renal impairment 60 - 89
3. Moderate renal impairment 30 - 59
4. Severe renal impairment 15 - 29 not requiring dialysis
5. End-Stage Renal Disease (ESRD) less than 15 or requiring dialysis treatment Renal group 5 (ESRD).

   * Participants requiring dialysis treatment should be on treatment with haemodialysis.

Exclusion Criteria:

* Any disorder, except for conditions associated with renal impairment, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
* Use of prescription medicinal products or non-prescription drugs, or non-routine vitamins, which at the investigators judgement may affect participant safety or the results of the study within 14 days before screening. Use of the following are allowed: Routine vitamins, occasional use of paracetamol, ibuprofen and topical medication not reaching systemic circulation.
* Use of drugs known to affect creatinine clearance including cephalosporin and aminoglycoside antibiotics, flucytosine, cisplatin, cimetidine, trimethoprim, cibenzoline and nitrofurantoin within 14 days or 5 half-lives, whichever is greater, before planned dosing of the investigational medicinal product (IMP).
* Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, gastrointestinal, or endocrinological conditions (except conditions associated with renal impairment or ESRD).
Screening for Anal Cancer in Women With High-grade Vulvar Dysplasia or Vulvar Cancer.

Almost half of all women will develop an HPV infection in their lifetime. While most infections are naturally asymptomatic or cleared by the immune system, some persist and can lead to the development of cervical, vulvar, or anal lesions and eventually cancer. Screening regimens for these lesions are currently only in place for the cervix through regular Pap tests. These Pap tests usually involve an examination of the vulva -however, no screening procedures exist for anal cancer for women. Several studies have suggested that women with existing gynecological lesions are more likely to develop anal lesions and anal cancer. Here the investigators propose a multi-center study which seeks to screen for and treat anal cancer in women over the age of 40 with vulvar lesions and a stable immune system. The investigators will achieve this through performing anal Pap smears on eligible women and conducting High Resolution Anoscopy (HRA) and appropriate treatment procedures on those with abnormal anal cells. With enough evidence, there may be an indication to establish regular anal cancer screening measures in this potentially underserved population.

Hypothesis: The investigators hypothesize that at least 40% of women with vulvar cancer or VIN2/3 will have abnormal anal cytology. 35% of the population will be hrHPV DNA positive and 11% will additionally have AIN2/3. This prospective study may lay the groundwork for routine anal screening regimens in Ontario and help shift health policy to treat this population.


Eligibility Criteria:
Inclusion Criteria:

* Women age ≥ 40
* Previous diagnosis of VIN 2/3 or vulvar

Exclusion Criteria:

* Women with a previous diagnosis of cancer aside from basal cell carcinoma of the skin, cervical cancer, or vulvar cancer
* Women who are HIV positive
* Women currently taking immunosuppressant medication
* Women who have had a previous hysterectomy
A Study on the Long Term Survivals in an Expand Access Program (EAP) of Iressa

The primary objective is to describe the quality of life of long-term survivors who are not terminated from the EAP.


Eligibility Criteria:
Inclusion Criteria:

* Provision of informed consent prior to any study specific procedures.
* Participated in the Iressa EAP in China.
* Diagnosed as NSCLC.
* Patients who started EAP at least 3 years before this study initiated and have not yet terminated from the EAP (active long-term survivors).
* Patients who consent to provide blood sample and available archival tumour tissue sample for EGFR gene testing (provision of tumour tissue sample is optional).

Exclusion Criteria:

* Patients who disagree to participate this study.
* Patients in whose medical objection was recorded to use the existing data from medical practice for scientific research.
Response to Influenza Virus Vaccination in Patients Immunocompromised Due to Chemotherapy

Patients treated with chemotherapy or immunosuppressives are at higher risk of influenza infection and mortality and morbidity are higher compared to healthy adults. Vaccination against the influenza virus can prevent these complications. In this study it is investigated whether vaccination during chemotherapy is effective in reaching protective serum antibody concentrations and the relation between time of vaccination (day 4 +/- 1 day versus day 16 +/- 1 day of the chemotherapy cycle).

This study will be conducted to answer the question whether vaccination during chemotherapy induces an adequate antibody response in oncology patients. Moreover, the effect of the timing of the vaccination during a chemotherapy cycle will be evaluated. In the mamma carcinoma patients, the effect of early versus late vaccination during a chemotherapy cycle will be studied. It was chosen to vaccinate in the early group at day 4 +/- 1 day; the immediate influence of the chemotherapy on the vaccination response is expected to have passed by then and patients will not already have their nadir. Late vaccination was defined as vaccination on day 16 +/- 1 day of the cycle. It is expected that the white blood cell and platelet counts by then are normalised.

In order to define a relatively homogenous patient population with mamma carcinoma, in this study patients will be recruited who are treated in the adjuvant setting with FEC-containing regimens (5-fluorouracil 500 mg/m2, epirubicin 100 mg/m2 and cyclophosphamid 500 mg/m2). The results of vaccination in these immunocompromised groups will be compared to the serological response to vaccination in persons who receive the influenza vaccination due to heart failure. Studies have shown that, although cytotoxic T-cell responses might be diminished, the rise in haemagglutinin inhibition titres in patients with heart failure vaccinated against influenza can be compared to the response to vaccination in otherwise healthy persons. These patients with heart failure will therefore be used as a control group. Patients with heart failure who are on treatment with immunosuppressives like prednisolone will not be included, because prednisolone diminishes the response to vaccination. The heart failure patients will be vaccinated according to the standard influenza vaccination protocol in the Netherlands.

Eligibility Criteria:
Inclusion Criteria:

* Patients with mamma carcinoma treated with FEC-containing triweekly chemotherapy at moment of vaccination
* Patients with heart failure and therefore having an indication for the influenza vaccination
* Age ≥ 18 years
* Signing of informed consent

Exclusion Criteria:

* Fever at time of vaccination defined as a temperature of ≥ 38.5 °C.
* Previous/known allergic reaction to any of the components of the vaccines given, for example hypersensitivity to egg protein
* Thrombocytopenia (defined as \< 50 \* 109/L ) at moment of vaccination
* Treatment with prednisolone on moment of vaccination.
Cervical Cancer Brachytherapy With Interstitial Needles in 3 Fractions

Aim To determine the feasibility and safety of 3 fractions of high dose rate (HDR) brachytherapy with interstitial needles for cervical cancer in the outpatient setting

Primary objective To determine the clinical outcome (2-yr local control rate, loco-regional control rate, progression free survival and overall survival)

Secondary objective To determine the long-term toxicities of this regimen based on CTCAE v5

This study is designed as a single arm phase II prospective study that will be open for recruitment for approximately 3 years. An estimated 56 cervical cancer patients treated in NUH will be recruited.

Pre-treatment Assessment

1. Case reviewed in gynae multidisciplinary meeting
2. Detailed gynaecologic assessment on diagnosis
3. Staging scan - MRI pelvis, CT TAP or PET CT
4. Baseline blood result - Full blood count, renal panel, liver panel, coagulation profile and Group screen and match

Treatment

All patients will be registered and reviewed in NUH Radiotherapy Centre. Written consent will be obtained if patient is agreeable to be recruited.

Brachytherapy A pre-brachytherapy planning magnetic resonance imaging (MRI) scan is performed to evaluate the response and extent of the parametrial involvement if any, as well as to determine the ideal placement of interstitial needles to achieve optimal coverage. The applicator to be used should be chosen prior to BT if possible. Twenty-four hours prior to the procedure, oral fleet is given to the patient to ensure adequate bowel preparation.

The 3 fractions of HDR brachytherapy may be delivered in the following ways:

Option 1: 3 insertions over 2 non-consecutive days:

9 Gy to the HRCTV in the first fraction on day 1 of the brachytherapy procedure and 7 Gy x 2 fractions at least 6 hours apart on day 2, retaining the same brachytherapy applicators of the second insertion for the final fraction.

Option 2: 3 insertions over 3 non-consecutive days 8Gy to the HRCTV per fraction per day for 3 non-consecutive days. Acute and late radiation toxicities will be scored according to Common Terminology Criteria for Adverse Events (CTCAE), version 5 Patients will be followed up at 1 month with a physical examination and with an MRI of the cervix within 3 months post procedure.

Patients will subsequently be followed up every 3 monthly with vaginal examination for the next 2 years. At each follow-up, toxicity will be recorded as per the CTCAE.

Eligibility Criteria:
Inclusion Criteria:

1. 21 years old and above
2. Histologically proven squamous cell carcinoma, adenocarcinoma, adenosquamous or poorly differentiated cervical cancer
3. Clinically or radiologically stage IB - IVA cervical cancer based on TNM 8th Edition
4. ECOG performance status 0, 1, or 2
5. To complete external beam radiotherapy and brachytherapy in NUH
6. Written, voluntary informed consent
7. Patients must be accessible for follow up and management in NUH

Exclusion Criteria:

1. Post operative cervical cancer cases
2. Pregnant or breastfeeding women
A Study to Assess the Efficacy and Safety of Alefacept in Psoriasis Patients for Whom Conventional Treatment is Ineffective or Inappropriate

To assess the efficacy and safety of Alefacept compared to placebo for the treatment of Chronic Plaque Psoriasis in patients for whom conventional therapies are ineffective and inappropriate

Patients who completed the initial 24-week treatment course (12 weeks of weekly dosing following b y 12 weeks of follow-up) and met the eligibility criteria continued in the 24-week open label extension

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Chronic Plaque Psoriasis involving ≥ 10% body surface area
* Treatment history for Psoriasis in which 3 or more conventional anti-psoriatic therapies are inappropriate or ineffective
* CD4+ T lymphocyte counts at or above the lower limit of normal

Exclusion Criteria:

* Clinically significant abnormal hematology values or blood chemistry values
* AST or ALT ≥ 3x the upper limit of normal
* Other types of Psoriasis
* Serious infection within the 3 months prior to the first dose of study drug
* History of drug or alcohol abuse within the past 2 years
* Antibody positive for HIV
* History of malignancy
* History of any clinically significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major disease
* Exposure to psoriasis-modifying phototherapy or high-potency topical corticosteroid therapy within 2 weeks prior to the first dose of study drug
* Exposure to systemic anti-psoriatic therapy , topical immunomodulators or topical CNIs within 4 weeks prior to the first dose of study drug
* Current treatment with any therapy for tuberculosis
* Previous exposure to Alefacept
* Nursing mothers, pregnant women, and women planning to become pregnant during the study
Ticagrelor and ASA vs. ASA Only After Isolated Coronary Artery Bypass Grafting in Patients With Acute Coronary Syndrome

The study is a Randomised Registry-based Clinical Trial (RRCT) to assess whether dual antiplatelet therapy with ticagrelor and ASA compared to ASA alone improves outcome after isolated CABG in patients with acute coronary syndrome.

The trial is a 1:1 randomized, interventional, multi-national, multi-center, safety/efficacy, parallel assignment, open-label treatment study and will use the RRCT methodology. A RRCT study utilizes existing health care registry platforms to conduct a pragmatic prospective randomized trial.

After the CABG, eligible patients that have consented to the study, will be randomized to either treatment arms. In the intervention arm, patients will be treated with ticagrelor 90 mg twice daily and ASA 75-100 mg daily for 12 months and patients in the control arm will get ASA only (75-160 mg daily according to local guidelines) during the same time period.

The patients will be followed by telephone interviews at 30 days and 365 days after inclusion. After the treatment period patients will be followed during an observation period by collection of outcome data from registries or medical records, 24, 36, 60 and 120 months after inclusion of the patient. No other data but the registry data or data from medical records will be collected.

Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent
2. Age ≥18 years
3. Has undergone first time isolated CABG due to an episode of acute coronary syndrome (STEMI, NSTEMI, unstable angina) within 6 weeks before surgery

Exclusion Criteria:

1. Previously enrolled in this study (i.e. patient now at repeat encounter)
2. Concomitant surgical procedure other than CABG
3. Anticoagulant treatment after the operation (e.g. warfarin, direct thrombin inhibitors (dabigatran), FXa inhibitors (rivaroxaban, apixaban, heparin, low-molecular weight heparin, fondaparinux)
4. Discharge from the operating hospital to an ICU at another hospital
5. Pregnancy or lactation
6. Known intolerance or contraindication to ticagrelor or ASA
7. Any disorder that may interfere with drug absorption
8. Any condition other than coronary artery disease with a life expectancy \<12 months
9. Known chronic liver disease, renal disease requiring dialysis or bleeding disorder
10. Atrioventricular block II and III in patients without pacemaker
11. Any other indication for dual antiplatelet therapy, i.e. recent stent implantation
12. Debilitating stroke within 90 days before inclusion
13. Previous intracranial bleeding
14. Treatment with immunosuppressants (e.g. cyclosporine and tacrolimus)
15. Treatment with strong CYP3A4-inhibitors (e.g. ketoconazole, clarithromycin, nefazodone, ritonavir or atazanavir)
16. Any condition that in the opinion of the investigator may interfere with adherence to trial protocol
17. Participation in any other clinical trial evaluating investigational products at the time for enrollment in this study
Analysis of Patient Seeking Second Opinion Who Are Undergoing Full Mouth Orthodontic Treatment

Patient safety is a great concern for the whole society. Since the investigators have a leadership in the medical field in Taiwan, the investigators should be courageous to face the reality from the patients seeking second opinions undergoing orthodontic treatment.

Orthodontics just became a recognized specialty by the Department of Health in Taiwan in 2009. It is just a beginning to set up the training course criteria at the national level. It will be a good timing for us to look at the treatment quality when patients seeking second opinions at NTUH. Whether the unsatisfied results are from the patient's unrealistic expectation, patient's compliance issue, doctor's diagnosis, treatment planning or skills, or a simple communication problem, depend on a good systemic analysis from the records and questionnaire collected in a timely fashion.

The investigators plan to ask patients who are undergoing full-mouth orthodontic treatment and seeking second opinion to join this study. The investigators will thoroughly explain to patients before they agree to take records and fill in questionnaire. Then the investigators use these records to perform root cause analysis.

Our hypothesis is that the risk of adverse event (AE) is related to the training quality, communication skills, patient's understanding and compliance. From these results, the investigators shall be able to assess the risk of AE and make the education policy either at continued education level or special training courses towards a patient satisfied treatment.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are not under full mouth fixed orthodontic treatment in National Taiwan University Hospital

Exclusion Criteria:

* Patient who only had partial orthodontic treatment
* Pregnancy