cyrilzakka/clinical-trials huggingface dataset:
High-Sensitivity Troponin in the Evaluation of Patients With Acute Coronary Syndrome

In patients with chest pain the diagnosis of a heart attack (myocardial infarction) is made where there is evidence of heart muscle damage using a blood test to measure the heart muscle protein troponin. A new a more sensitive troponin test may help us to identify patients with myocardial infarction more easily.

The investigators propose to evaluate whether use of a novel high-sensitivity troponin test to lower the threshold for diagnosis of myocardial infarction is appropriate. If increased sensitivity does not reduce specificity for the diagnosis, then this new test will improve patient outcome through better targeting of therapies for coronary heart disease. However, if increased sensitivity leads to poor specificity, then patients may be misdiagnosed and given inappropriate cardiac medications with potentially detrimental outcomes.

In ten secondary and tertiary care hospitals across Scotland, the investigators will undertake a stepped wedge cluster randomized controlled trial of the implementation of a novel high-sensitivity troponin test. The primary end-point will be the one-year rate of cardiovascular death or recurrent myocardial infarction. This will establish whether the introduction of this high-sensitivity troponin test into routine clinical practice is beneficial to patient management and outcomes.

A subset of patients will be asked to give consent for inclusion into a sub-study that will permit storage of blood samples and will require the completion of a survey during the index admission and after 6 and 12 months of follow up.


Eligibility Criteria:
Inclusion criteria:

* Suspected acute coronary syndrome
* Troponin I measurement as part of routine clinical care

Exclusion criteria:

- None
Autologous Bone Marrow Stem Cells for Children With Autism Spectrum Disorders

The purpose of this study is to determine whether the plasticity of autologous intrathecal hematopoietic cells would improve the neurologic and the social skills of pediatric patients with autism spectrum disorders.

There is accumulating evidence that shows that the administration of hematopoietic cells into the brain in the patients with spectrum autism could help in the physiopathology of the illness.

It has been found that after introducing hematopoietic cells in the subarachnoid space of the spinal cord, these cells may be transported through the cerebrospinal fluid and can be delivered more efficiently to the injured area, when compared to the intravenous route.

Patients will be stimulated for 3 consecutive days with granulocyte colony stimulating factor (G-CSF) and then their bone marrow will be harvested according to their weight. Bone marrow will be processed in order to obtain CD34+ cells and minimize the amount of red blood cells. An inoculum of 5 to 10mL of stem cells will be infused intrathecally. Patients will be evaluated with two scales "CARS" and the "IDEA" also we will check the clinical history. On days 0, 30 and 180.

Eligibility Criteria:
Inclusion Criteria:

* children with autism spectrum DSM4-TR

Exclusion Criteria:

* Patients with neurodegenerative or autoimmune diseases.
* Patients with active infection in any organ or tissue at the time of entering the study, the onset of stimulation with G-CSF or at the procedure.
* Patients who do not sign the informed consent form.
What User-requirements Need to be Considered When Developing a Lower-limb Exoskeleton? A Qualitative Study.

The goal of this study is to identify the needs and requirements of end-users regarding the implementation of a lower-limb exoskeleton in a remote home setting. The end-users include older adults with sarcopenia, post-stroke individuals and physiotherapists. The main question it aims to answer is:

• What are the needs and requirements of the end-user population when developing a lower-limb exoskeleton that can be implemented in a remote home setting?

Participants will engage in three separate focus group sessions, in which they will discuss the predetermined topics. Interactions between the participants will be guided by open questions.


Eligibility Criteria:
People post-stroke:

Inclusion Criteria:

* \> 18 years old
* ≥ 3 months ago stroke diagnosis
* Current difficulties during gait

Exclusion Criteria:

* Serious speech disorder
* Lowered cognitive competence

Older adults with sarcopenia:

Inclusion Criteria:

* \> 65 years old
* Difficulties during chair sit to stand
* Current difficulties during gait

Exclusion Criteria:

* Lowered cognitive competence

Physiotherapist:

Inclusion Criteria:

* Currently active as a physiotherapist
* Experience in treating people with sarcopenia and/or post-stroke conditions

Exclusion criteria:

* Can't verbally answer
Use of Wearables to Detect Infections in Kidney Transplant Recipients

The goal of this observational study is to develop a machine learning algorithm for early detection of infections in kidney transplant recipients using data recorded by wearable digital health technologies.

The main questions it aims to answer are:

1. What are the biometric data pattern changes in impending infections?
2. What accuracy the machine learning algorithm can achieve?

Participants will be given/use their own wearable device that will record biometric data. Any infection event will be recorded and an algorithm will be trained to recognize changes in biometric data preceding symptomatic infection.


Eligibility Criteria:
Inclusion Criteria:

* kidney transplant recipient
* age 18 years or more
* kidney allograft function (eGFR based on CKD-EPI more than 15ml/min/1.73m2)

Exclusion Criteria:

* recipient of another transplanted organ
* terminal failure of another organ (heart, liver, lung)
* diabetes mellitus type 1
* pregnant or breastfeeding woman
* refusal to give informed consent
Virtual Reality for Neglect Diagnostics

Compared to the classical "paper and pencil"-tests, testing patients in our virtual reality setup might have a higher sensitivity and specificity.


Eligibility Criteria:
Inclusion Criteria for neglect patients:

* age ≥18 and \<80 years
* first stroke
* neglect symptoms
* no hemianopsia symptoms
* consent given by the patient

Inclusion Criteria for hemianopsia patients:

* age ≥18 and \<80 years
* first stroke
* no neglect symptoms
* hemianopsia symptoms
* consent given by the patient

Inclusion Criteria for Controls:

* age ≥18 and \<80 years
* no neurological deficits
* informed consent

Exclusion Criteria (for all groups):

* language comprehension deficits
* motor deficits of the upper extremities
* cognitive impairments (MMSE \<20 or SKT \>15 or DEMTEC \>12)
* depression
* seizure disorders
* claustrophobia
Effectiveness and Safety of Adalimumab in Rheumatoid Arthritis Patients in Routine Clinical Practice

Observation of safety, tolerability and effectiveness of adalimumab (Humira) therapy in a large patient collective under everyday clinical conditions over a 5-year period.

Patients with Rheumatoid Arthritis and started treatment with adalimumab in a normal clinical setting according to the label were documented. The follow-up observation period was for 5 years and focused on safety information and maintenance of efficacy during the normal clinical setting. Follow-up with participants was via regular office visits at intervals as determined by routine clinical practice or as recommended by national guidelines.

Eligibility Criteria:
Inclusion Criteria:

* Moderate to severe active rheumatoid arthritis in adults with insufficient response to disease-modifying antirheumatic drugs, including methotrexate.
* Moderate to severe active rheumatoid arthritis in adults who have not been treated with methotrexate before.
* In case of incompatibility with methotrexate, adalimumab can be used as monotherapy

Exclusion Criteria:

* Hypersensitivity against the drug or one of the other ingredients; active tuberculosis or other severe infections (e.g. sepsis and opportunistic infections); moderate to severe cardiac insufficiency
Clinical Evaluation of Hydrogels vs Silicone Hydrogel Contact Lenses

The aim of this fitting study is to evaluate the clinical performance of different hydrogel and silicone hydrogel contact lenses.

This is a 20-subject, double masked, randomized, contra lateral, 2-day non-dispensing fitting trial.

Eligibility Criteria:
Inclusion Criteria:

A person is eligible for inclusion in the study if he/she:

* Is between 18 and 40 years of age (inclusive)
* Has had a self-reported visual exam in the last two years
* Is an adapted soft contact lens wearer
* Has a cl spherical prescription between -1.00 and -6.00 (inclusive)
* Has a spectacle cylinder up to 0.75D (diopter) in each eye
* Is correctable to a visual acuity of 20/25 or better in both eyes
* Has clear corneas and no active ocular disease
* Has read, understood and signed the information consent letter
* Is willing to comply with the wear schedule
* Is willing to comply with the visit schedule

Exclusion Criteria:

A person will be excluded from the study if he/she:

* Has never worn contact lenses before
* Currently wears rigid gas permeable contact lenses
* Has a history of not achieving comfortable contact lens wear (5 days per week; \> 8 hours/day)
* Has a contact lens prescription outside the range of -1.00 to -6.00D
* Has a spectacle cylinder ≥ 1.00D of cylinder in either eye
* Has best corrected spectacle distance vision worse than 20/25 in either eye
* Has any systemic or topical medications that will affect ocular health
* Has any ocular pathology or severe insufficiency of lacrimal secretion
* Has persistent, clinically significant corneal or conjunctival staining
* Has active neovascularization or any central corneal scars
* Is aphakic
* Is presbyopic
* Has undergone corneal refractive surgery
* Is participating in any other type of eye related conical or research study
Lung Ventilation and Perfusion in Different Phenotypes of Chronic Critical Illness With Prolonged Mechanical Ventilation

This project will conduct a series of analysis of physiological and clinical data on tracheostomy patients who receive prolonged mechanical ventilation, hoping to find out the different manifestations of patients through the investigation by a variety of physiologic measurements, so as to understand whether different types of patients phenotype to derive different clinical strategies for liberation of the mechanical ventilator.


Eligibility Criteria:
Inclusion Criteria:

* Patients with at least 10 days of mechanical ventilation at the intensive care unit of National Taiwan University Hospital and transferred to the Respiratory Care Center of National Taiwan University Hospital for weaning training
* Patients who have undergone tracheostomy and still have a tracheotomy tube
* Are at least 20 years old
* Stable respiratory condition with inspired oxygen fraction not exceeding 50%

Exclusion Criteria:

* Hemodynamic instability or continuous use of vasopressors
* Pregnancy
GROWing Up With Rare GENEtic Syndromes

Introduction Rare complex syndromes Patients with complex genetic syndromes, by definition, have combined medical problems affecting multiple organ systems, and intellectual disability is often part of the syndrome. During childhood, patients with rare genetic syndromes receive multidisciplinary and specialized medical care; they usually receive medical care from 3-4 medical specialists.

Increased life expectancy Although many genetic syndromes used to cause premature death, improvement of medical care has improved life expectancy. More and more patients are now reaching adult age, and the complexity of the syndrome persists into adulthood. However, until recently, multidisciplinary care was not available for adults with rare genetic syndromes. Ideally, active and well-coordinated health management is provided to prevent, detect, and treat comorbidities that are part of the syndrome. However, after transition from pediatric to adult medical care, patients and their parents often report fragmented poor quality care instead of adequate and integrated health management. Therefore, pediatricians express the urgent need for adequate, multidisciplinary adult follow up of their pediatric patients with rare genetic syndromes.

Medical guidelines for adults not exist and the literature on health problems in these adults is scarce. Although there is a clear explanation for the absence of adult guidelines (i.e. the fact that in the past patients with rare genetic syndromes often died before reaching adult age), there is an urgent need for an overview of medical issues at adult age, for 'best practice' and, if possible, for medical guidelines.

The aim of this study is to get an overview of medical needs of adults with rare genetic syndromes, including:

1. comorbidities
2. medical and their impact on quality of life
3. medication use
4. the need for adaption of medication dose according to each syndrome

Methods and Results This is a retrospective file study. Analysis will be performed using SPSS version 23 and R version 3.6.0.


Eligibility Criteria:
Inclusion Criteria:

* Patients with rare syndromes or rare congenital diseases visiting the multidisciplinary outpatient clinic for patients with rare diseases at the department of endocrinology, internal medicine, Erasmus Medical Center.

Exclusion Criteria:

* None
Surveillance of Non-invasive Streptococcus Pneumoniae Infections in Belgium

The investigators will conduct a prospective observational study of non-invasive S. pneumoniae infections in Belgium and characterize serotype distributions to evaluate national vaccination programs.

The investigators will conduct a surveillance of non-invasive S. pneumoniae infections in Belgium (September 2020-May 2025). Monthly, 12 peripheral hospitals will send the first 15 unduplicated clinical S. pneumoniae samples (coming from patients diagnosed with pneumonia, otitits media or sinusitis) to the investigators. The investigators will determine the serotype and the antibiotic resistance profile of these clinical isolates. Whole genome sequencing will be performed on a subset of these isolates.

From May 2021, 13 extra participating centers have been added to the study.

Eligibility Criteria:
Inclusion Criteria:

* Patients living in Belgium at the time of the study,
* from whom unduplicated S. pneumoniae isolates were collected in routine practices,
* from non-invasive upper (e.g.: pus/fluid from nasal sinus or from otitis media fluid) or lower respiratory tract (e.g. sputum bronchial or endotracheal aspirate, bronchoalveolar fluid (BAL),...) clinical samples,
* from patients diagnosed with pneumonia, sinusitis and otitis.

Exclusion Criteria:

• Patients for whom S. pneumoniae was simultaneously isolated from blood or another usually sterile specimen
Take Charge of Your Diabetes

The investigator plans to assess enrollment rates among two different enrollment methods, while providing a behavioral economic intervention to enhance the uptake of home-health monitoring devices to lower hemoglobin A1C among patients with uncontrolled diabetes. The study is focusing on enrollment methods since the standard randomized control trial only reaches 15% of the population. The study is seeking to understand the effectiveness of a behavioral intervention, when rolled out in a larger population.


Eligibility Criteria:
Inclusion Criteria:

1. Adults between 18 and 80 years of age
2. Primary care patients at the Division of General Internal Medicine clinics at the University of Pennsylvania
3. Hemoglobin A1c measured within the last 8 weeks greater than 8.0% OR no measured Hemoglobin A1C measured in the last two years
4. A confirmed diabetes diagnosis
5. Planning to stay in area for study duration (6 months)
6. Can understand and communicate fluently in English

Exclusion Criteria:

1. Unable to read and give consent
2. Suffer from an uncontrolled psychiatric disease
SORT-OUT VI - Randomized Clinical Comparison of Biomatrix Flex® and Resolute Integrity®

To perform a randomized comparison between the BioMatrix Flex™ and the Resolute Integrity® stents in the treatment of unselected patients with ischemic heart disease.

SORT OUT VI is a randomized, multicenter, all-comer, two-arm, non-inferiority trial comparing the Biolimus-eluting Biomatrix Flex and the Zotarolimus-eluting Medtronic Resolute Integrity in treatment of atherosclerotic coronary artery lesions.

Primary Endpoint:

Target lesion failure within 12 months of stent implantation (combination of cardiac death, myocardial infarction (not index procedure related) not related to other than index lesion or target lesion revascularization).

Secondary Endpoints:

Individual components of the primary end point comprised the secondary end points and stent thrombosis rate according to the Academic Research Consortium definition (see protocol for further specification of secondary endpoints).

Clinically driven event detection will be used to avoid study-induced reinterventions. Data on mortality, hospital admission, coronary angiography, repeat percutaneous coronary intervention, and coronary bypass surgery will be obtained for all randomly allocated patients from the following national Danish administrative and healthcare registries: the Civil Registration System; the Western Denmark Heart Registry; the Danish National Registry of Patients, which maintains records on all hospitalizations in Denmark; and the Danish Registry of Causes of Death

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years or over with chronic stable coronary artery disease or acute coronary syndromes, and at least one coronary artery lesion with more than 50% diameter stenosis, requiring treatment with a drug-eluting stent.

Exclusion Criteria:

* life expectancy of less than one year
* an allergy to aspirin, clopidogrel, ticagrelor, prasugrel, sirolimus, or biolimus
* participation in another randomized trial
* inability to provide written informed consent
Short-course Radiotherapy Followed by CAPOX and Ivonescimab for Locally Advanced Rectal Cancer

This study is a single-arm, prospective, phase II clinical study to evaluate the efficacy and safety of preoperative short-course radiotherapy combined with ivonescimab and chemotherapy + total mesorectal excision(TME) surgery in patients with advanced rectal cancer.

Studies included a screening period (no more than 28 days after participants signed informed consent form to 28 days before first dose), treatment (receiving appropriate treatment until disease progression, intolerable toxicity, withdrawal of informed consent, death or study end, whichever occurs first), and follow-up (including safety follow-up and survival follow-up).

Eligible subjects will receive short-course radiotherapy (SCRT), pelvic 25Gy/5f/1 week. 1-2 weeks after the end of treatment, subjects continued to receive neoadjuvant chemotherapy combined with immunotherapy regimen for 4 cycles: ivonescimab 20 mg/kg, intravenous infusion every 3 weeks (Q3W), plus CAPOX (capecitabine: 850-1000mg/m2, bid, po, d1-14, oxaliplatin: 130mg/m2, ivgtt, d1), Q3W. Neoadjuvant therapy was assessed 2 weeks after the end of neoadjuvant therapy, and TME surgery was performed 4 weeks after the end of neoadjuvant therapy (R0 surgery was performed). Patients can choose to enter the organ preservation observation; If the efficacy after preoperative chemoradiotherapy is evaluated as clinical complete remission (cCR) and the patient strongly refuses surgery, the patient should be informed of the risk of recurrence and ask the patient to sign a rejection of surgery. Medication safety is assessed and, depending on the severity of adverse events (AEs) and drug relevance, investigators will take steps to ensure subject safety. After surgery (or patients who strongly refuse surgery) there is a 30- and 90-day safety follow-up, and survival assessments are performed every 3 months to obtain survival information and collect new tumor treatment information until the death of the participant, withdrawal of informed consent, or the end of the study, whichever occurs first.

Eligibility Criteria:
Inclusion Criteria:

* ECOG score of 0-1;
* histologically or cytologically confirmed colorectal adenocarcinoma with non-distant metastasis
* Tumor distance from anal verge ≦10cm
* at least one high-risk criterion defined by pelvic MRI: cT stage \>T2 (tumor invades intrinsic muscularis propria by more than 5 mm); Extramural vascular invasion; cN2; Involvement of the rectal mesorectal fascia (tumor or lymph node ≤1mm from the rectal mesorectal fascia); Lateral lymph node short diameter ≥5mm
* enough organ function

Exclusion Criteria:

* with known MSI-H or dMMR
* Multiple primary adenocarcinomas
* History of pelvic radiotherapy
* Previous immunotherapy, including immune checkpoint inhibitors (e.g., anti-PD-1 antibody, anti-PD-L1 antibody, anti-CTLA-4 antibody, etc.), immune checkpoint agonists (e.g., ICOS, CD40, CD137, GITR, OX40 antibody, etc.), immunocellular therapy, and other treatments targeting the immune mechanism of the tumor.
RC48-ADC in HER2-low Advanced Breast Cancer

To evaluate the efficacy and safety of Disitamab vedotin (RC48-ADC) as salvage treatment in patients with HER2-low advanced breast cancer who have received up to one previous chemotherapy for recurrent or metastatic disease without previous use of antibody-drug conjugate.

Subjects with HER2-low advanced breast cancer were treated with Disitamab vedotin as salvage treatment. ORR, PFS, OS and AE were assessed during the trial. HER2-low status is defined as IHC1+ or IHC2+ with negative FISH test.

Eligibility Criteria:
Inclusion Criteria:

* Female patients aged 18-70 years (including 18 years and 70 years)
* Expected survival ≥12 weeks
* ECOG 0-1
* Histologically confirmed invasive advanced or metastatic breast cancer that is incurable and unresectable
* At least one measurable lesion according to the RECIST 1.1
* No history of antibody-drug conjugate use
* Up to one previous chemotherapy for advanced disease
* Available hormone receptor status. Hormone receptor-positive subjects are allowed to receive no more than two previous endocrine therapy for advanced disease
* HER2-low tumors, defined as IHC1+ or IHC2+ with negative FISH test
* Adequate organ function

Exclusion Criteria:

* History of thromboembolic events
* Uncontrolled systemic diseases, including diabetes, hypertension, interstitial lung disease, cirrhosis, etc.
* Active infections requiring systemic treatment
* Pregnant or lactating
* Presence of brain metastases and/or carcinomatous meningitis
Mobile Chat Messaging for Alcohol Reduction in Patients With Chronic Liver Diseases

The goal of this pilot randomized controlled trial is to evaluate the trial feasibility and acceptability of mobile chat messaging for reducing alcohol use among patients with chronic liver diseases. Specific objectives include:

1. To assess whether the eligibility criteria were too restrictive by estimating the eligibility rate
2. To assess how many eligible CLD patients accepted the invitation to participate in the trial
3. To assess the participant retention rate through 6 months after treatment initiation
4. To assess the intervention acceptability in terms of participants' engagement with and rating of the chat messaging intervention.
5. To assess the safety of the intervention
6. To estimate the intervention effect on alcohol use outcomes and liver functions
7. To synthesise data to inform the sample size calculation in the future definitive trial
8. To explore the participants' perception and experiences in the chat-based intervention


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years
2. Diagnosed with chronic liver disease
3. Alcohol Use Disorders Identification Test score ≥8
4. Own a smartphone with a mobile instant messaging app installed
5. Able to read and communicate in Chinese

Exclusion Criteria:

1. Having a psychiatric or psychological disease or on psychotropic drugs
2. Participating in other alcohol reduction or abstinence programmes
3. Require emergency or in-patient treatment after consultation