cyrilzakka/clinical-trials huggingface dataset:
Real-world Study on Edoxaban Treatment for Patients With Non-valvular Atrial Fibrillation in China

The safety of edoxaban treatment will be examined using real-world clinical evidence from adult patients with non-valvular atrial fibrillation (NVAF) indications in routine clinical practice.

This non-interventional, observational study will evaluate the safety of edoxaban treatment in adult patients with NVAF indications with one or more risk factors.

The primary objective of the study is to collect and evaluate safety data up to 2 years in a real-world setting in relation to adverse event onset (related to edoxaban treatment), duration, severity, and outcome.

The secondary objective will evaluate the effect of edoxaban treatment on stroke (ischemic and hemorrhagic), systemic embolic event (SEE), transient ischemic attack (TIA), major adverse cardiovascular events (MACE), venous thromboembolism (VTE), acute coronary syndrome (ACS), hospitalization related to cardiovascular condition, extent of exposure and compliance to edoxaban therapy, and rate and reasons of permanent discontinuation of edoxaban therapy.

Eligibility Criteria:
Inclusion Criteria:

* Written, informed consent
* NVAF-patients treated with edoxaban according to packaging information (i.e., for NVAF adult patients with one or more risk factors (such as history of congestive heart failure, hypertension, age ≥75 years old, diabetes, prior stroke or TIA) in prevention of stroke and systemic circulation embolism)
* Not participating in any interventional study at the same time

Exclusion Criteria:

* Not applicable
Music Program for Hong Kong Adolescents: Improving Emotion Regulation and Reducing Depression, Anxiety, and Loneliness

This study is a clinical trial that aims to test and validate a music-based program called "Tuned In" in helping adolescents in Hong Kong improve their mental well-being. The researchers want to find out if the program can help participants enhance their ability to regulate their emotions, reduce mood symptoms and feelings of loneliness.

Participants in the study will be randomly assigned to either the group that receives the program right away (intervention group) or the group that waits for four weeks before receiving the program (wait list group). They will take part in a group-based weekly program for four weeks. Additionally, they will be asked to complete questionnaires before and after the program to see if there are any changes in their mental well-being. The program will be delivered by a facilitator with a psychology background, and a registered music therapist.

By addressing the gaps in mental health interventions for young people in Hong Kong, this study aims to contribute to the development of effective strategies to support their emotional well-being.


Eligibility Criteria:
Inclusion Criteria:

* self-report as having problems with low mood, anxiety or loneliness
* score 3 or above on the General Health Questionnaire (GHQ-12), which indicates psychological distress.
Adjunctive Clindamycin Versus Linezolid for β-lactam Treated Patients With Invasive Group A Streptococcal Infections

This study aims to emulate a hypothetical target pragmatic multi-center, non-blinded trial of adult inpatients in the PINC AITM dataset with B-lactam treated culture confirmed monomicrobial invasive Group A streptococcus (GAS) between the years 2015-2021


Eligibility Criteria:
Inclusion Criteria:

* Adult inpatients patients (=\> 18 y of age)
* Monomicrobial Group A streptococcus invasive infection
* Primary therapy with a B-lactam agent (initiated before or on same day as adjunctive anti-toxin therapy)

Exclusion Criteria:

* Patients with a polymicrobial GAS culture (non-GAS organisms identified on eligibility GAS culture)
* Patients who received linezolid but have a documented linezolid resistant isolate
* Patients with GAS infections of non-sterile non-invasive sites (i.e sites which do not meet above mentioned inclusion criteria) which include but not limited to the lower urinary tract, upper respiratory tract
* Patient with concomitant MSSA/MRSA invasive infection (+/- seven days of index GAS eligibility culture)
* Patients who receive both anti-toxin agents (violation of protocol)
* Patient who do not complete at least 3 days of B-lactam (violation of protocol)
Validation Study of the Accuracy of E/e' in Estimating Left Ventricular Filling Pressure

The non-invasive estimation of left ventricular end diastolic pressure (LVeDP) is a main goal for performing an echocardiography in the routine clinical practice. Conflicting evidence exists about mitral E/e' ratio reliability for predicting high LVeDP


Eligibility Criteria:
Inclusion Criteria:

* Age over 18 years
* Patient performing an echocardiography in the routine clinical practice
* Informed consent given

Exclusion Criteria:

* Severe valve disease, valvular prostheses, calcification of the mitral valve, the history of myocardial infarction, atrial fibrillation, severe arrhythmias not allowing the Doppler analysis, pacemaker and any image by inadequate Doppler ultrasound
* Major person under legal protection (backup justice, trusteeship, guardianship), person deprived of liberty.
Adjuvant Transcatheter Arterial Chemoembolization Versus Adjuvant Systemic Chemotherapy for Hepatocellular Carcinoma

The purpose of this study is to determine that adjuvant systemic chemotherapy is superior to adjuvant transcatheter arterial chemoembolization(TACE) in prolonging recurrence free survival（RFS） in patients after radical resection of hepatocellular carcinoma.


Eligibility Criteria:
Inclusion Criteria:

1. a preoperative diagnosis of HCC with no previous treatment;
2. compensated cirrhosis with Child-Pugh class A, B or no cirrhosis;
3. multiple tumors more than 5 cm or tumor involving a major branch (the Wrstor second branch) of the portal or hepatic vein(s) on preoperative investigations, and on intraoperative ultrasonography and gross examination of the liver during operation;
4. on exploration and intraoperative ultrasonography, the tumor with multiple lesions localized in right or left hemiliver,or the main tumor localized in one lobe only with a small solitary lesion in contralateral lobe, or tumor involving a major branch (the Wrst or second branch) of the portal or hepatic vein(s), which could be safely resected without grossly remaining tumors, and the patient was judged to have well preserved liver function to survive the operation.
5. Adequate organ and marrow function, with neutrophil count≥1.5X10e9/L, platelet count≥75×10e9/L, AST or ALT﹤2.5×upper limit of normal (ULN), total bilirubin\<1.5×ULN, international normalized ratio \<1.5;normal baseline left ventricular ejection fraction_lower limit of normal for the institution. Patients with AST and ALT\<5 ×ULN could be recruited if total bilirubin was in the normal range.

Exclusion Criteria:

1. documented allergy to study drugs; any previous TACE or systemic chemotherapy treatment before random assignment;
2. concomitant use of any other anticancer therapy, including interferon alfa and herbal medicine approved by the local authority to be used as anticancer medicine (except palliative radiotherapy to a nontarget lesion);
3. CNS metastasis;
4. Other serious illness or medical condition.
Sleep and Quality of Life in Patients With Glycogen Storage Disease on Standard Versus Modified Uncooked Cornstarch

The aim of the present study is to determine if there is a change in quality and quantity of sleep perceived by adults and children with GSD and their parents while starting a modified UCCS (Glycosade) to prevent nocturnal hypoglycemia. The investigators also aim to evaluate if there is a change in quality of life perceived by adults and children and their parents with Glycosade.

This is a prospective cohort study. Patients above 2 years old and their parents (for children only) will be enrolled during their usual follow-up. Parents will be asked to complete a quality of sleep questionnaire (as it pertains to both child and parent) relating to the past month on their current dietary regimen (standard UCCS) and a quality of life questionnaire (as it pertains to the child only). Parents will then complete a sleep diary (for both child and parent) and both child and parent will wear an actigraph that will record movements during sleep over a 1 week period. Adult GSD patients will complete their own questionnaires. Following this first assessment, they will be hospitalised over a 24 hour period as part of standard of care to start the modified UCCS, Glycosade, under supervision and with a continuous glucose monitoring (CGM) sensor. Following hospitalization, the family will return home. Glucose will be monitored with the aid of the CGM sensor for 5 to 7 days. The actigraphy and the sleep diary will be repeated after 2 weeks (for 1 week) while on Glycosade. One month after starting the modified UCCS, questionnaires on quality of sleep and quality of life will be repeated.

Eligibility Criteria:
Inclusion Criteria:

* Patients of ≥ 2 years old with a diagnostic of GSD 0, I, III, VI, IX or XI based on a liver biopsy, mutation in the appropriate gene or clinical evidence of GSD with a positive familial history
* Medical history of fasting hypoglycemia
* Currently taking standard UCCS
* With a stable condition
* Followed in GSD clinics at the Montreal Children's Hospital and the Hôpital St-Luc
* With informed consent obtained

Exclusion Criteria:

* Continuous overnight feeds
Ultrasound Biomicroscopy - Apoptosis

A group of researchers at the Ontario Cancer Institute/Princess Margaret Hospital have discovered that a very specific form of cell death 'apoptosis' can be detected using high-frequency ultrasound imaging. This type of cell death is recognized to occur in tumours in response to various different chemotherapeutic drugs and in response to radiation therapy. This group of researchers has confirmed that high-frequency ultrasound can detect apoptosis in response to tumour treatments experimentally using cell culture and experimental animal systems. The ultrasound approach is now being evaluated clinically in a 3-year clinical trial enrolling a target of 200 patients including Hodgkin's disease and non-Hodgkin's disease lymphoma patients, melanoma patients and patients with basal cell carcinoma. Our hope is to be able to use this type of imaging system in the future to clinically monitor the effects of therapy on tumours and rapidly detect tumours which are not responding so that changes in therapy can be made much quicker than presently possible.


Eligibility Criteria:
Inclusion Criteria:

* lymphoma patients with superficial lesions prior to starting chemotherapy or after relapse of disease
* patients with superficial melanoma lesions
* patients with superficial basal cell carcinoma lesions
* Informed consent

Exclusion Criteria:

-
Dentists' Understanding of Diagnostic Test Results and Treatment Efficacy.

There is little evidence on how best to present diagnostic and treatment effect information to dentists and whether this makes any difference to their understanding of the information given and clinical management. The objective of this study is to assess the influence of different formats for presenting diagnostic test results and treatment efficacy on dentists' understanding and on their reported clinical management. The hypothesis is that presenting diagnostic test and treatment effectiveness results using natural frequencies influences the threshold for treatment and improves interpretation of tests results compared to conditional probabilities and percentage differences. A group of dentists recruited from postgraduate courses were randomized to two of four arms, being two arms of a hypothetical realistic diagnostic scenario (a) and two arms of a hypothetical realistic treatment scenario (b): a1) diagnostic test results presented in conditional probabilities; a2) diagnostic test results presented in natural frequencies; b1) treatment efficacy presented in percentages; b2) treatment efficacy presented in natural frequencies. The main outcome measures were the correct answer as to whether disease was actually present (post-test probability) and the correct answer as the number of patients that would benefit from the treatment (efficacy). Secondary outcome measures included the decision whether to treat or not treat the hypothetical patient.


Eligibility Criteria:
Inclusion Criteria:

* Graduated dentist undergoing a postgraduate course in a public university in Rio de Janeiro.

Exclusion Criteria:

* None.
Phase 3 Study to Evaluate the Efficacy & Safety of Tralokinumab in Adults & Adolescents With OCS Dependent Asthma

A Multicentre, Randomized, Double-blind, Parallel Group, Placebo Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Tralokinumab in Reducing Oral Corticosteroid dependent Asthma.

This is a randomized, double-blind, parallel group, placebo-controlled study designed to evaluate the efficacy and safety of a fixed 300 mg dose of tralokinumab administered subcutaneously every 2 weeks in adult and adolescent subjects with oral corticosteroid dependent asthma. Approximately120 subjects will be randomized globally. Subjects will receive tralokinumab or placebo, administered via subcutaneous injection at the study site, over a 40-week treatment period.

Eligibility Criteria:
Inclusion Criteria:

1) Age 12-75 2) Documented physician-diagnosed asthma. 3) Documented treatment with ICS at a total daily dose corresponding to ≥500µg fluticasone propionate dry powder formulation and a LABA. 4) Subjects must have received OCS for the treatment of asthma for 6 months prior to Visit 1 and on a stable OCS dose between ≥7.5 to ≤30mg daily or daily equivalent for at least one month prior to enrolment (Visit 1) . 5) Pre-BD FEV1 value \<80% (\<90% for patients 12-17 yrs of age) of their PNV. 6) Post-BD reversibility of ≥12% in FEV1.

Exclusion Criteria:

1) Clinically important pulmonary disease other than asthma. 2) History of anaphylaxis following any biologic therapy. 3) Hepatitis B, C or HIV. 4) Pregnant or breastfeeding. 5) History of cancer. 6) Current tobacco smoking or a history of tobacco smoking for ≥10 pack-years. 7) Previous receipt of tralokinumab.
Multicenter Study Evaluating the Performance of the Assay of Anti-hinge Region Antibodies in the Diagnosis of Progressive Forms of IgA Nephropathy

The anti-hinge region antibodies would be a relevant biomarker of IgA nephropathy. Beyond a prognostic value (which could increase the risk of Renal Absolute), the longitudinal monitoring for these antibodies could be of interest: (1) in the monitoring of patients (in place including a possible repetition renal biopsy); (2) to guide treatment decisions and (3) in clinical research, as an outcome (in substitution for the occurrence of kidney failure) in therapeutic trials IgA nephropathy.

This research project constitutes the first step in validating these antibodies biomarker of IgA nephropathy and its main objective is to study the performance of the blood levels of anti-hinge region antibodies in the diagnosis of progressive forms of histologically IgA nephropathy as defined by the Renal Risk Absolute.

The secondary objectives of this project are to establish a bio-collection that will allow us to search for other prognostic factors (genetic, cellular and serum) of IgA nephropathy and to evaluate the performance of Renal Absolute risk by integrating Oxford score, the new international histological classification.


Eligibility Criteria:
Inclusion Criteria:

* Major Patient
* Diagnosis of a primitive form of IgA nephropathy histologically proven

Exclusion Criteria:

* Suspicion of secondary IgA nephropathy forms
* Less than 5 glomeruli present on renal biopsy
Detection of K14 in Bladder Cancer With a Non Invasive Technique

By an invasive technique keratin 14 has been identified as a prognostic factor in bladder cancer. This study aims to analyze whether through a non-invasive technique keratin 14 can be used as a diagnostic and prognostic marker for this cancer.


Eligibility Criteria:
Inclusion Criteria:

* Bladder cancer

Exclusion Criteria:

* Inability to sign the informed consent
Upper Limb Function and Visuospatial Exploration After Stroke

This project is a cross-sectional, observational mono-center study with prospective data collecting.

This study aims to further explore quality of upper limb movement in relation to characteristics of visuospatial exploration in stroke subjects and healthy subjects by a applying comprehensive measurements of clinical scales and kinematic data in capacity- and performance-based activities. The results will contribute to assessing and monitoring quality of upper limb movements and visuospatial attention and their relationship.


Eligibility Criteria:
Inclusion Criteria:

* Subjects of 18 years and older with chronic ischemic stroke (\> 6 month) restricted to one hemisphere (confirmed by CT/MRI)
* With impairments in upper limb function and at least partial ability to lift the arm against gravity, flex and extend the fingers
* Without relevant pre-existing limitations in arm and hand function (orthopaedic, muscular, neurologic)
* Written informed consent after participants's information

Exclusion Criteria:

* Increased muscle tone in the upper limb with limited rang of motion
* Severe sensory deficits in the upper limb
* Clinically significant concomitant disease (affecting the upper limb or impaired vision, e.g. due to glaucoma etc.)
* Contraindications on ethical grounds (vulnerable persons)
* Known or suspected non-compliance, drug or alcohol abuse
* Severe communication or cognitive deficits, that cause inability to follow the procedures
Motor Response to Sildenafil in PD

Sildenafil (Viagra(R))is widely used by men with Parkinsons Disease (PD) and erectile dysfunction. A number of patients have reported that when they take Sildenafil, their need of anti-PD medication is reduced.

We hypotheses that sildenafil increases brain blood flow and hence improves the function of specific brain regions, improving motor function.

Motor function and cerebral blood flow of 8 patients will be tested before and after Sildenafil intake and before and after anti-PD medication.

Erectile dysfunction can be experienced by up tp 40% of men with Parkinsons Disease (PD). Sildenafil (Viagra(R))is widely used by men with PD and erectile dysfunction. A number of patients have reported that when they take Sildenafil, their need of anti-PD medication is reduced.

We hypotheses that sildenafil increases cerebral blood flow in basal ganglia and hence improves the function, improving motor function.

Motor function and cerebral blood flow (rCBF) of 8 patients will be tested before and after Sildenafil intake and before and after anti-PD medication.

rCBF will be measured by the Xe133 inhalation method and a fast-rotating, brain-dedicated, single photon emission computerized tomograph (SPECT, Tomomatic, 232, Medimatic, Inc., Denmark). Two scans will be perfomed, when patients are i)in normal medicated state and ii) in normal medicated state 1 hour after intake of 100 mg sildenafil.

Motor function will be measured i 4 conditions: i)in normal medicated state and ii) in normal medicated state 1 hour after intake of 100 mg sildenafil, iii) after 12 hours of discontiation of anti-PD mediciation and iiii) after 14 hours of discontiation of anti-PD mediciation and 1 hour after intake of 100 mg sildenafil.

Eligibility Criteria:
Inclusion Criteria:

* Men
* Parkinsons disease
* Erectile dysfunction
* previous tried sildenafil with beneficial effects on motor function

Exclusion Criteria:

* psychosis
* Heart disease
Second Ovulation Induction

Studies reported various risk factors for inadequate ovulation induction such as body mass index, low ovarian reserve, low baseline FSH and LH, and previous use of contraception or agonist.

The flexibility to use human chorionic gonadotropin (hCG) or gonadotropin-releasing hormone agonist (GnRHa) in ovulation induction for antagonist protocol or progestin primed ovarian stimulation (PPOS) is an advantage helping fertility doctors to decrease the risk of ovarian hyperstimulation syndrome. However, luteinizing hormone (LH) levels \<15UI/L and progesterone ≤11.13nmol/L eight to twelve hours post GnRHa trigger were highly correlated to failed oocyte pickup (FOP).

Rescue hCG have been found to increase favorable outcomes in patients with FOP. The presence of false FOP could be due pharmaceutical reasons and human error. Genuine FOP could be due to intrinsic ovarian pathology.

The FOP is defined as the absence of oocytes after ovarian stimulation and follicular aspiration. It is an uncomfortable situation for the patient and medical team to deal with due to the apparent expectations of favorable results.

Ovulation induction could be via GnRHa, HCG, or both in antagonist protocol and PPOS protocol. Long or short agonist protocol could be triggered only via HCG.


Eligibility Criteria:
Inclusion Criteria:

* Participants with no oocytes retrieved in the first ovum pick-up

Exclusion Criteria:

* Error in trigger medication or timing by the patient/ medical team
* Major absence of information (primary objective, trigger medication, time interval of trigger and ovum pick-up
Short-term Study of Two Soft Contact Lenses in Wearers With Low Astigmatism

The primary objective of the study is to evaluate and compare the performance of two soft contact lens.

The primary objective of the study is to evaluate and compare the performance of two different soft contact lens in existing spherical soft contact lens (CL) wearers with low levels of refractive astigmatism over a 2-week wear period.

Eligibility Criteria:
Inclusion Criteria:

1. At least 17 years and no more than 42 years of age.
2. Have read and signed the study consent form.
3. Are willing and able to follow instructions and maintain the appointment schedule.
4. Are habitual wearer of spherical soft contact lenses (not toric or multifocal design), any brand and any replacement frequency.
5. Are willing to wear the study contact lenses for 6 days a week while in this study and on three days (day 1, Day 7 and Day 13) for at least 12 hours.
6. Are willing to provide a contact email and telephone number and to use a device that allows them to respond to a short online questionnaire every 3 hours on days 1, 7 and 13 of each lens arm, while wearing one of the 2 study lenses.
7. Are non-presbyopic i.e. no requirement for a reading addition for routine daily tasks (self report).
8. Have astigmatism of either -0.50, -0.75, -1.00 or -1.25 DC in each eye by subjective sphero-cylindrical refraction.
9. Achieves at least 0.10 LogMAR in each eye by subjective sphero-cylindrical refraction.
10. Can be fit with available study contact lens powers of between +6.00 to -10.00 DS.
11. Demonstrate an acceptable fit with the study contact lenses.

Exclusion Criteria:

1. Are participating in any concurrent clinical interventional study.
2. Have worn rigid contact lenses in the last 3 months.
3. Have worn soft toric contact lenses in the past 3 months.
4. Have any known active ocular disease or allergies and/or infection.
5. Have clinically significant biomicroscopy findings or have an ocular condition that contraindicate contact lens wear.
6. Have a systemic condition that in the opinion of the investigator may affect a study outcome variable or contraindicate wearing soft contact lenses.
7. Are using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable or contraindicate wearing soft contact lenses.
8. Have known sensitivity to the diagnostic sodium fluorescein to be used in the study.
9. Have undergone refractive error surgery or intraocular surgery.
10. Are an employee of the Centre for Ocular Research \& Education directly involved in this study.