cyrilzakka/clinical-trials huggingface dataset:
In-depth Immunological Investigation of COVID-19.

The COntAGIouS trial (COvid-19 Advanced Genetic and Immunologic Sampling; an in-depth characterization of the dynamic host immune response to coronavirus SARS-CoV-2) proposes a transdisciplinary approach to identify host factors resulting in hyper-susceptibility to SARS-CoV-2 infection, which is urgently needed for directed medical interventions.

The overall aim of this prospective study is to provide an in-depth characterization of clinical and immunological features of patients hospitalized in UZ Leuven because of SARS-CoV-2 infection. For this purpose, clinical data and blood, nasopharyngeal/rectal swab, and if safe, bronchoalveolar lavage (BAL) fluid and lung tissue samples will be collected from PCR- or CT-confirmed COVID-19 patients, with varying degrees of disease severity. Assessed characteristics will be compared between severe and non-severe COVID-19 patients, and between COVID-19 positive and negative ('control') patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients \>/= 18 years old AND
* Hospitalised with PCR-confirmed and/or CT-confirmed SARS-CoV-2 disease

Exclusion Criteria:

* Age \< 18 years old
* No informed consent
Stress Reduction Intervention for Enhancing Treatment Outcome for Depressed Minority Patients

The purpose of this study is to determine the usefulness of a stress reduction treatment in helping minority patients with major depression get better. Subjects will receive six weeks of either mindfulness-based stress reduction and problem solving therapy or psychoeducation.

The purpose of this study is to determine the usefulness of a stress reduction treatment compared to psychoeducation in helping minority patients with major depression get better.

The study will last 10 weeks. During the main portion of the study, subjects will receive either individual weekly sessions of stress-reduction therapy or psychoeducation for six weeks. The stress reduction therapy will consist of mindfulness-based stress reduction and problem solving therapy, which focuses on linking psychological problems with psychosocial issues and helping you use your skills and resources to improve your functioning. The psychoeducation will consist of six sessions of education on depression and the treatment and management of symptoms. Each session will last 50 minutes, and four of the visits will also include filling out questionnaires which will take approximately 15-30 minutes to complete. One month after the last session, subjects will come in for a follow-up visit with a study clinician to see how they are doing and to fill out questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* Meet criteria for current major depressive disorder
* Men or women aged 18-75 who self-identify as a member of a racial or ethnic minority group
* Has a PCP, therapist, psychiatrist, etc aware of their depression. Or, subject agrees to seek outside mental health treatment/management

Exclusion Criteria:

* Pregnancy
Evaluating the Use of SR34006 Compared to Warfarin or Acenocoumarol in Patients With Atrial Fibrillation (AMADEUS)

This trial will include patients who have a heart condition called atrial fibrillation. Atrial fibrillation is an abnormal rhythm (irregular beat) in the heart. Patients with atrial fibrillation have an increased chance for a blood clot to form in the heart and move to other blood vessels in the body and cause obstruction. This obstruction may damage tissue. For example, a blood clot plugging a vessel in the brain could cause a stroke. Therefore, patients with atrial fibrillation may be given anticoagulant (blood-thinning) tablets such as warfarin or acenocoumarol.

The purpose of this study is to compare the safety and effectiveness of a new injectable anticoagulant drug that is administered once weekly, SR34006 with warfarin or acenocoumarol tablets.

Assignment to either SR34006 Injection or vitamin K antagonist (warfarin or acenocoumarol) tablets will be purely by chance and will be known by both patients and their doctors.


Eligibility Criteria:
Inclusion Criteria:

* ECG-documented atrial fibrillation (AF) and an indication for long-term vitamin K antagonist (VKA) therapy based on the presence of at least one of the following risk factors:

  1. previous ischemic stroke, transient ischemic attack (TIA) or systemic embolism
  2. hypertension requiring drug treatment
  3. left ventricular dysfunction (left ventricular ejection fraction \<45% or symptomatic congestive heart failure)
  4. age \>75 years
  5. age between 65-75 years plus diabetes mellitus, or
  6. age between 65-75 years plus symptomatic coronary artery disease (previous myocardial infarction (MI) or angina pectoris)
* Written informed consent

Exclusion Criteria:

* Legal lower age limitations (country specific)
* Indication for VKA other than AF, including prosthetic heart valves, venous thromboembolism, and planned cardioversion
* Transient AF caused by a reversible disorder
* Active bleeding or high risk of bleeding
* Recent (\<15 days) or anticipated invasive procedures with potential for uncontrolled bleeding, including major surgery
* Participation in another pharmacotherapeutic study within the prior 30 days
* Creatinine clearance \<10 mL/min, severe hepatic disease, or bacterial endocarditis
* Uncontrolled hypertension: systolic blood pressure \> 180 mm Hg and/or diastolic blood pressure \> 110 mm Hg
* Pregnancy or childbearing potential without proper contraceptive measures
* Breastfeeding
* Any other contraindication listed in the labeling of warfarin or acenocoumarol
PET/MRI and Biomarkers in Bladder Cancer

Muscle invasive bladder cancer is an aggressive malignancy. Currently the investigators lack accurate imaging technologies in clinical staging and estimation of response to neoadjuvant chemotherapy as well as prognostic biomarkers.

In the current study novel imaging modality (MRI/PET) is utilized to stage bladder cancer prior to transurethral resection of bladder-tumor and after neoadjuvant chemotherapy. Also prognostic biomarkers are studied from TUR-BT tissues, blood and urine to estimate response to neoadjuvant chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* invasive or locally advanced bladder cancer based on cystoscopic evaluation
* Age: 18 to 85 years old
* Language spoken: Finnish or Swedish
* Mental status: Patients must be able to understand the meaning of the study
* Informed consent: The patient must sign the appropriate Ethical Committee (EC) approved informed consent documents in the presence of the designated staff

Exclusion Criteria:

* Prior medical history: Patient must have no history of serious cardiovascular, liver or kidney disease
* Infections: Patient must not have an uncontrolled serious infection
* Contraindications for MRI (cardiac pacemaker, intracranial clips etc)
* Patient refusing radical cystectomy or chemotherapy
* Intravesical Bacillus Calmette-Guerin instillations within 6 months
Multi-center, Prospective, Cohort Study to Evaluate the Relationship of Stroke Recurrence and Anti-platelet Resistance in Ischemic Stroke Patients

This cohort study will evaluate the relatiobship of stroke recurrence and anti-platelet resistance in ischemic stroke patients


Eligibility Criteria:
Inclusion Criteria:

1. Men and women over 60 years old at the time of written consent
2. Those admitted to the hospital within 72 hours after acute cerebral infarction and treated with Aspirin 100 mg and Clopidogrel 75 mg
3. Written informed consent voluntarily signed

Exclusion Criteria:

1. Those with evidence other brain lesions such as brain tumors
2. Those who need oral anticoagulants other than vitamin K antagonists or anticoagulant therapy of warfarin
3. Contraindicate to Aspirin or Clopidogrel or allergic to the drug
4. Subjects who are at risk of active pathological bleeding such as digestive ulcer and intracranial hemorrhage
5. Cancer disease that can shorten life expectancy
6. Patient's condition that may interfere with participation in study such as mental illness, mental retardation, dementia, drug abuse, and alcoholism
7. Subjects other than the above unsuitable for this clinical study identified by Investigator
Impact of Foot Mobility Techniques on Balance and Pressure in Young Adults

This study aims to evaluate the effectiveness of specific foot mobility techniques on functional and biomechanical parameters of the foot in young adults aged 18 to 24 years. The study employs a randomized controlled trial design with the following key components:

Key outcomes include:

Baropodometric pressures (measured using a baropodometric platform). Balance (evaluated through the Y-Balance Test). Navicular height (assessed using the Navicular Drop Test) Anterior functional reach (measured through functional reach test)

This study explores the immediate and short-term effects of specific foot mobility techniques on functional and biomechanical outcomes in healthy young adults. The research is grounded in the growing recognition of the foot's critical role in postural control, balance, and lower-limb biomechanics.

The intervention consists of foot mobility techniques designed to improve joint mobility and overall foot function. These techniques will be applied bilaterally. The study employs a randomized controlled trial design, with participants randomly allocated to either the experimental group (receiving the intervention) or the control group (receiving no treatment during the intervention period).

Participants are assessed at three time points:

Baseline (M0): Before the intervention. Immediately Post-Intervention (M1). Follow-Up (M2): 24 hours after the intervention.

The primary outcomes include:

Changes in plantar pressure distribution and postural control as measured by a baropodometric platform.

Balance performance assessed through the Y-Balance Test. Navicular height variation evaluated using the Navicular Drop Test. Anterior functional reach, measured by Functional Reach Test. The study focuses on identifying measurable improvements in functional and biomechanical parameters that may enhance clinical approaches to foot health and rehabilitation. By targeting a young and healthy population, the research aims to establish a foundation for further studies in other age groups and clinical conditions. This work aims to contribute to evidence-based practices in manual therapy and foot biomechanics.

Eligibility Criteria:
Inclusion Criteria:

* minimum age of 18 years.

Exclusion Criteria:

* pregnant women,
* individuals with lesions in the lower limbs in the last 12 months,
* history of congenital deformity in the lower limb
* presence of vestibular or balance disorders
* users of corrective insoles or orthoses.
Clinical Study of Desmoteplase in Japanese Patients With Acute Ischemic Stroke

The purpose of the study is to evaluate whether desmoteplase is safe and tolerated when given to Japanese patients with acute ischemic stroke

The study is a safety and tolerability study of desmoteplase in Japanese patients with acute ischemic stroke. The study will test two doses

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of acute ischemic stroke
* Provided Informed Consent
* Male or female
* Aged between 20 and 85 years inclusive
* Treatment within 3-9 hr after onset of stroke symptoms.
* NIHSS score of 4-24 inclusive with clinical signs of hemispheric infarction
* Must receive IMP within 60 minutes after brain imaging
* Cerebral artery occlusion or high-grade stenosis in MCA

Exclusion Criteria:

* Pre-stroke mRS score of \>1
* Previously exposed to desmoteplase
* Scores \>2 on NIHSS question 1a indicating coma
* History or clinical presentation of ICH, subarachnoid haemorrhage (SAH), arterio-venous malformation (AVM), moyamoya disease, cerebral neoplasm or aneurysm
* Current use of oral anticoagulants and a prolonged prothrombin time (INR \>1.6)
* Treated with heparin in the previous 48 hours and has a prolonged partial thromboplastin time
* Baseline platelet count \<100,000/mm3
* Baseline haematocrit of \<0.25
* Baseline blood glucose \<50 mg/dl or \>200 mg/dl
* Uncontrolled hypertension defined by a blood pressure, systolic \>185 mmHg or diastolic \>110 mmHg on at least 2 separate occasions at least 10 minutes apart
* Patient has hereditary or acquired hemorrhagic diathesis
* Gastrointestinal or urinary bleeding within the past 21 days
* Arterial puncture in a non-compressible site within the previous 7 days
* Another stroke or a serious head injury in the past 6 weeks
* Major surgery or serious injury, including other sites than the head, within the preceding 14 days
* Seizure at the onset of stroke
* Acute myocardial infarction (AMI) within the previous 3 weeks
* Thrombolytic within the previous 72 hr
* Pregnant

Other inclusion and exclusion criteria may apply.
A Short Treatment Study of Aripiprazole in Pediatric Patients With Autistic Disorder

The objective of this study is to investigate the efficacy and safety of aripiprazole orally administered over a period of 8 weeks in pediatric patients with Autistic Disorder


Eligibility Criteria:
Inclusion Criteria:

* The patient meets current DSM-IV-TR diagnostic criteria for Autistic Disorder (defined in DSM-IV-TR) and also demonstrates behaviors such as tantrums, aggression, self-injurious behavior, or a combination of these problems.
* Inpatient or outpatient status
* Others

Exclusion Criteria:

* The patient is currently diagnosed with another disorder on the autism spectrum in DSM-IV-TR, including Asperger's, Rett's Disorder, PDD-NOS, Childhood Disintegrative Disorder, or Fragile-X Syndrome.
* Patients who fall under a contraindication listed in the ABILIFY package insert
* Others
Prevalence of DAO (diamino Oxidase) Deficiency in Newborns

Observational study to estimate the prevalence of genetic DAO deficiency in the population.

Diamine oxidase (DAO) is an enzyme encoded by the AOC1 gene responsible for the degradation of extracellular histamine. There are different factors that can induce a decrease in the DAO activity, with genetic origin being the main one. Currently, multiple genes have been identified SNPs that can alter the correct functioning of the DAO. The four most relevant SNPs that lead to a reduction in the enzymatic activity of DAO or a transcriptional activity decreased in this are the following: c.47C\>T (rs10156191), c.995C\>T (rs1049742), c.1990C\>G (rs1049793) and c.-691G\>T (rs2052129). Clinical studies indicate that DAO deficiency has a high prevalence in diseases such as Migraine (87%), fibromyalgia (75%) or attention deficit hyperactivity disorder (ADHD) in children (75%). However, to date no study has been conducted exploring the prevalence gene of DAO deficiency in the general population. Thus, the objective of this study is to estimate the prevalence of genetic DAO deficiency in the population.

Eligibility Criteria:
Inclusion Criteria:

* Newborns
* Both sexes
* Explicit acceptance of the parents or guardians of participation through the signature of the informed consent

Exclusion Criteria:

* None
Pilot Study of Management of Facial Paralysis in the Oncologic Patient: Nerve Transfer Techniques to Improve Facial Function and Quality of Life

The goal of this research study is to measure changes in patients' quality of life after surgeries that affect the facial nerve, including nerve transfer as treatment for facial paralysis.

Primary Objective:

To evaluate the impact of facial nerve transfer techniques (FNTT) on QoL in head and neck cancer patients with facial paralysis. This study intends to measure the impact of FNTT on QoL utilizing a series of validated questionnaires which include: (i) Facial Clinimetric Evaluation Scale and Facial Disability Index; (ii) Sunnybrook Facial Grading System; and (iii) Facial Nerve Grading Scale 2.0. These instruments will be administered at baseline, after surgery, and at 6, 12, and 18 months post-operatively.

Secondary Objective:

To compare patient-reported outcomes and facial function scales for patients who undergo facial nerve transfer technique with a historical cohort of patients who did not undergo any dynamic nerve reconstruction procedures. The same assessment tools described in primary objective above will be utilized.

Eligibility Criteria:
Inclusion Criteria:

In order to be eligible to participate in the intervention group of this study, an individual must meet all of the following criteria:

* Provision of signed and dated informed consent form
* Aged 18 or greater
* Patient scheduled to undergo facial nerve transfer
* Stated willingness to comply with all study procedures and lifestyle considerations and availability for the duration of the study

In order to be eligible to participate in the non-intervention historical control group of this study, an individual must meet all of the following criteria:

* Provision of signed and dated informed consent form
* Aged 18 or greater
* Previous facial surgery severing a facial nerve without graft or other form of dynamic facial nerve reconstruction within the last 5 years

Exclusion Criteria:

Patients known to be pregnant
DVT Ultrasound in the Emergency Department

Emergency Medicine (EM) Residents routinely conduct bedside ultrasound exams in the Emergency Department (ED) employing the two point compression method. This study endeavors to investigate the accuracy and utility of bedside ultrasound for Deep Vein Thrombosis (DVT) in the ED by EM Residents by comparing the results of that exam against the gold standard of a DVT ultrasound performed in the Radiology Department and interpreted by a Radiologist.

For subjects with suspicion of DVT to the Emergency Department, an EM Resident will perform a bedside non-diagnostic two point compression DVT Ultrasound. Subjects will then receive a diagnostic DVT Ultrasound in the Radiology Department with official radiologist interpretation. The bedside ultrasound will not interfere with or delay the diagnostic ultrasound. Patient demographic and clinical data will be collected for validation purposes. Validation of the The EM Resident interpretation will be accomplished by comparison to the official Radiologist interpretation.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Suspect of having DVT

Exclusion Criteria:

* Known DVT
* DVT with in previous 6 months
* DVT Ultrasound within the last 6 months
Long-Term Follow-Up of TX200-TR101 (STEADFAST Long Term)

This long-term follow-up study is being conducted to collect long-term (up to 15 years post-infusion) safety and tolerability data from subjects enrolled in studies evaluating TX200-TR101.

This is long- term follow up observational trial for patients who participated previously to a multicentre, first-in-human, open-label, single ascending dose, dose-ranging study of autologous, chimeric antigen receptor T regulatory cells (CAR-Treg) in HLA-A2 mismatched living donor kidney transplant recipients, with a control cohort of mismatched kidney transplant recipients of similar immunological risk.

The aim is for this observational long-term follow up study (TX200-KT03) is to collect long-term (up to 15 years post-infusion) safety and tolerability data from subjects enrolled in studies evaluating TX200-TR101. In addition, the long-term effects and durability of the clinical effect of TX200-TR101 in subjects who received TX200-TR101 will be assessed and compared with control participants in the interventional Study (TX200- KT02).

Eligibility Criteria:
Inclusion Criteria:

1. Subjects who enrolled in the Phase I/IIa study TX200-KT02, received a transplanted kidney and have either completed or withdrawn from that study.
2. Willing and able to provide written informed consent (IC) in accordance with local regulations and governing Independent Ethics Committee (IEC)/Institutional Review Board (IRB) requirements prior to any procedure or evaluation performed specifically for the sole purpose of the study.

Exclusion Criteria:

* N/A
COVID-19 Pandemic and Worldwide Organ Procurement

End-stage organ failure is estimated to affect more than 4 to 6 million persons worldwide. In 2018, transplant systems across the globe enabled around 150,000 patients to benefit from a kidney, heart, lung, liver, or other solid organ, a number that was far less than the demand. According to data from the World Health Organization, more than 1,500,000 persons live with a transplanted organ worldwide. In the US, approximately 40,000 patients receive an organ transplant every year, but 120,000 still remain waitlisted for transplantation today, with 7,600 dying annually while waiting for an organ transplant. A similar lack of organs and high death rates on the waiting list affect patients in Europe and many other countries.

As nations adjust to new realities driven by the coronavirus (COVID-19) outbreak, many health care providers, institutions and patients are concerned about the potential impact that COVID-19 will have on organ donation and transplantation. One concern is that transplant recipients may have a greater susceptibility to infection and greater viral burden. A second concern is that hospitals will lack the resources in terms of staff and equipment to care for recipients after transplantation, who often require intensive care and multispecialty management.

Because of the overwhelming healthcare system burden, a dramatic negative effect on worldwide organ donation and transplantation is anticipated, but has not been measured. Our objective was to quantify the worldwide impact of COVID-19 pandemic on organ donation and transplantation and consequences for waitlisted patients.


Eligibility Criteria:
Inclusion Criteria:

* All organs procured for transplantation and transplanted during the observation period. These include kidney, lung, liver, heart, and combined transplantations.

Exclusion Criteria:

* None
Influence of Early Standing Training on ICU Patients

Influence of early standing training on ICU patients

Objective: To study the effect of early standing training on ICU patients.Background: Early severe rehabilitation is of great significance for patients, which can help patients withdraw from mechanical ventilation as soon as possible, improve pulmonary ventilation, and promote early walking.However, patients on mechanical ventilation are more prone to delirium, muscle weakness, ventilator dependence and other problems. Early standing training can significantly improve patients' lower limb muscle strength, improve diaphragm function, improve the prognosis of patients, and reduce the length of hospital stay.Methods: selecting stable hemodynamics in ICU patients with mechanical ventilation, randomly divided into two groups, a group of routine rehabilitation training, another group stand for regular rehabilitation and early training, with the aid of electric beds, on the first day of patients, to evaluate the seventh day, the 14th day, and collect the basic information for patients and strength assessment, blood gas analysis, the diaphragm of the bed and ultrasound and muscle ultrasound, and record the patient's mortality within 28 days, the incidence of delirium, decannulation rate, etc., recorded in patients with mechanical ventilation time and the time required to walk independently and ICU stay time.

Eligibility Criteria:
Inclusion Criteria:

* The age is ≥ 18 years old;
* the hemodynamics is stable;
* 50 \< heart rate \< 120 beats / min ;
* 90 \< systolic blood pressure \< 200mmHg ;
* 55 \< mean arterial pressure \< 120mmHg;
* do not increase the dose of pressor drugs for at least 2 hours;
* intracranial pressure is stable and there are no seizures within 24 hours;
* the respiratory state is stable;
* the patient's finger pulse oxygen saturation ≥ 88%;
* Oxygen concentration less than 60%；
* Terminal positive expiratory pressure\<12cmH2O；
* 10 \< respiratory frequency \< 35 beats / min.

Exclusion Criteria:

* Pregnancy;
* acute cardio-cerebrovascular events;
* spinal or limb fractures;
* active bleeding.