cyrilzakka/clinical-trials huggingface dataset:
ATP Expression in Lymphocytes of MS Patients by Means of "ImmuKnow®" Assay.

The purpose of this study is to see if we can find a new way to test how certain Multiple Sclerosis (MS) medications work in the body and to better understand how the medicines change certain substances (cells) found in the immune (protective) system.

Blood test will be drawn by doing the following:

* Use a new method called the "Immuknow®" Test to see if this method will help to better understand how MS medicines work.
* Measure certain levels of immune cells in a new way, to see if it this will help to understand the body's response to MS medicines.

These methods will test those with MS who are not taking any MS medications, to help us compare the results.

About 100 subjects will be enrolled in this study at the Partners Multiple Sclerosis Center at Brigham and Women's Hospital. Biogen Idec, Inc. of Cambridge, MA, is paying for this study to be done.

The primary objective of this study is to determine the effects of various therapies (immunomodulatory as well as immunosuppressive) on ATP levels in CD4+ cells and to determine whether the "ImmuKnow®" assay is an appropriate screening tool to assess the immunocompetence of potential Tysabri patients.

Secondary objective is to correlate the expression of ATP in CD4+ cells with CD4+ cell count.

Tertiary objective is to examine the level of regulatory T-cells (CD4+ and CD25+) in MS patients and its possible correlation to the therapy used, and how well a recently proposed marker of regulatory T-cells, LAP, correlates with CD25 marker.

Eligibility Criteria:
Inclusion Criteria:

1. Patients must be taking 1 of the following medications for 3 months or more: Cytoxan, Cellcept, Novantrone Betaseron, Rebif, Avonex or Copaxone.
2. Patients must be able to provide written informed consent.

Exclusion Criteria:

1. Patients on combination of multiple medications.
2. Restricted treatment whereby no use in 50 days prior to enrollment visit is permitted: systemic steroids.
3. With educational completion below 8th grade school equivalent or non-fluent in English.
4. Any other reason, in the opinion of both the Investigator and/or Sponsor, the patient is determined not suitable for study participation.
Canine-assisted ANxiety Reduction IN Emergency

The purpose of this study is to see if dogs can reduce the anxiety level of patients in the emergency department.

Patients will score their pain, anxiety, and depression. A dog will then come into the patient's room for approximately 15 minutes after which the patient will score his/her pain, anxiety, and depression again.

Eligibility Criteria:
Inclusion Criteria:

* Research staff will screen for inclusion criterion by asking the care providers if they agree with this statement, "I believe this patient is experiencing moderate or greater anxiety".

Exclusion Criteria:

* Extreme intoxication, agitation that precludes conversation with the patient, fear of dogs, dog bite, allergy to dogs.
CoaguChek XS in Antiphospholipid Antibody Syndrome (APL) Patients

The purpose of this study is to see if the CoaguChek XS is accurate in measuring International Normalized Ratio (INR) in patients with Antiphospholipid Antibody Syndrome (APL) receiving warfarin therapy.

Antiphospholipid Antibody Syndrome (APL) is an autoimmune disease that increases ones risk for blood clots. Therefore, these patients receive anticoagulation therapy with warfarin. Point of care devices such as the CoaguChek XS are often used to monitor International Normalized Ratio (INR) in patients on warfarin. However, the antibodies present in patients with APL may lead to false INR results when using the CoaguChek XS. This study will compare the accuracy of the CoaguChek XS in measuring INR in patients with APL by measuring INR by the CoaguChek XS and a standard lab as a reference point. Patients on warfarin for indications other than APL will be measured by both methods as well to serve as a control group.

Eligibility Criteria:
Inclusion Criteria:

* 18-65 years of age
* anticoagulated with warfarin for at least 1 month
* Diagnosis of antiphospholipid antibody syndrome for intervention arm

Exclusion Criteria:

* any type of mental disability that would hinder their ability to give informed consent
* any terminal illness or any other condition that could interfere with study completion, that person will be excluded.
D-OCT for Detection and Subtyping of BCC: a Diagnostic Cohort Study

The current gold standard for diagnosing basal cell carcinoma (BCC) is the histopathological examination of biopsy specimen. However, non-invasive imaging modalities such as optical coherence tomography (OCT) may replace biopsy if BCC presence and its subtype can be established with high confidence. Subtype differentiation is crucial; while superficial BCCs (sBCC) can be treated topically, nodular (nBCC) and infiltrative BCCs (iBCC) require excision. Dynamic OCT (D-OCT) is a functionality integrated within the OCT device, enabling the visualization of vascular structures through speckle variance.

Descriptive studies have unveiled vascular shapes and patterns associated with BCC and its respective subtypes. These findings suggest that D-OCT could contribute to the accuracy of BCC detection and subtyping. Yet comparative clinical studies between OCT and D-OCT are lacking. In the proposed diagnostic cohort study, we aim to assess whether D-OCT assessment is superior to OCT in terms of accuracy for BCC detection and subtyping.


Eligibility Criteria:
Inclusion Criteria:

* 18+ years
* Lesions suspect for non-melanoma skin cancer or premalignancy
* Patient underwent D-OCT scan and biopsy conform regular care

Exclusion Criteria:

* Patient unable to sign informed consent.
Research to Evaluate a Possible Relation Between Values Obtained After Processing CT Images, Lung Function Tests and the Experience of the Patient During an Exacerbation in COPD Patients.

In this study the consequences of exacerbations will be visualized by high resolution computed tomography (HRCT) scan at functional residual capacity (FRC) and total lung capacity (TLC) as taken during an episode of exacerbation and after recovering. Changes in HRCT based airway dimensions and computational fluid dynamic (CFD) -based resistance values will be correlated with changes in patient reported outcomes (PROs) and lung function tests recorded at the same time.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, ≥ 40 years old
* COPD as defined by the global Initiative on obstructive lung disease4
* Post-bronchodilator FEV1/FVC \< 70% AND post-bronchodilator FEV1 \<80%pred as documented in the last 5 years.
* Smoking history of at least 10 pack-years
* At entry in the study experiencing an exacerbation defined as an acute change in the patient 's baseline dyspnea, cough, and/or sputum that is beyond normal day to day variations, and that necessitates the administration or doubling of systemic corticosteroid treatment.
* Patients must be able to understand and complete protocol requirements, instructions, questionnaires and protocol-stated restrictions.
* Written and signed informed consent

Exclusion Criteria:

* Pregnant or lactating females
* Patient diagnosed with asthma
* Patient with pneumonia as defined radiologically at the start of the exacerbation
* Patient with a history of or presence of lung cancer
* Patient with an indication for non-invasive ventilation
* Patient unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study.
* Patient who received any investigational new drug within the last 4 weeks prior to visit 1.
Genomics and COVID-19 Vaccine Adverse Events

Vaccines routinely used are extremely safe; however, severe adverse events to vaccines do occur. As vaccination against COVID-19 has begun, adverse events to the vaccine, particularly Guillain-Barré syndrome (GBS), vaccine-induced immune thrombotic thrombocytopenia (VITT)/thrombosis with thrombocytopenia syndrome (TTS), and myocarditis/pericarditis, after COVID-19 vaccination have been reported worldwide.

Study hypothesis: there are genetic factors that contribute to increased risks of particular COVID-19 vaccine-induced adverse events.

The objective of the study is to determine if there are specific genetic factors strongly associated with each of the COVID-19 vaccine-induced adverse events (i.e., GBS, VITT/TTS, and myocarditis/pericarditis).

Purpose:

Reduce the risk of COVID-19 vaccine-induced adverse events (i.e., GBS, VITT/TTS, and myocarditis/pericarditis) through improved understanding of the biology underlying these severe adverse events and the genetic contribution to their cause

Research Design:

* Prospective case-control study designs will be performed to investigate the genetic associations of Guillain-Barré syndrome (GBS), vaccine-induced immune thrombotic thrombocytopenia (VITT)/thrombosis with thrombocytopenia syndrome (TTS), and myocarditis/pericarditis strongly associated (OR ≥ 3.0) with COVID-19 vaccination.
* Determined cases of specific COVID-19 vaccine-induced GBS, VITT/TTS, and myocarditis/pericarditis, and vaccinated controls without these adverse events will be included.
* Saliva DNA samples from eligible adverse event cases and vaccinated controls will be collected.
* Candidate gene and genome-wide association studies (GWAS) approaches will be conducted.
* Genomics analyses will be stratified by severity, age, sex, vaccine, and other critical covariates as determined by the GVDN Work Group for each adverse event and as adequately powered analyses allow.
* To complement GWAS, particularly in protein-coding regions, additional whole-exome sequencing (WES) will be performed on the most severe patients who are categorized as Brighton Collaboration Level One case of COVID-19 vaccine-induced adverse events to identify the most possible disease-causing mutations.

Eligibility Criteria:
Inclusion Criteria:

* Case: Any patient who received COVID-19 vaccines and developed GBS, VITT/TTS, or myocarditis/pericarditis after vaccination
* Control: Any participant who received COVID-19 vaccines and does not experience GBS, VITT/TTS, or myocarditis/pericarditis.

Exclusion Criteria:

* Individuals who have not received a COVID-19 vaccine
* Individuals who are unable to provide informed consent
Pilot Study : New Sensors to Monitor Apnea During Sedation

Evaluation of a Mandibular and Abdominal Motion Detection Sensor (JAWAC) to Prevent Apnea During Sedation With Propofol in TCI Mode

In 2016 , monitoring of propofol sedation , currently recommended by the American Society of Anaesthesiology and European companies includes among others, a pulse oximeter (SpO2) and a continuous measurement of CO2 exhaled by an appropriate device (CapnoLine). This monitoring does not allow to anticipate the occurrence of obstructive apnea .

The anticipation of the occurrence of apnea or airway obstruction using this type of monitoring could allow the anesthesiologist to act earlier on the titration of propofol and maintaining the airway. This would avoid the side effects associated with hypoxemia and hypercapnia and therefore further improve patient safety .

This pilot study tests the JAWAC system to detect those apneas.

This is an interventional diagnostic study on the JAWAC monitoring system validation in a prospective cohort of patients undergoing sedation in order to provoke sleep apnea. Indeed , sedation technique is already used with propofol during snoring provocation tests in patients at risk for sleep apnea.

Eligibility Criteria:
Inclusion Criteria:

* Any adult patient scheduled for a sleep apnea provocation test under sedation by propofol
* Hospital Erasme during the period of the study.

Exclusion Criteria:

1. Patient Refusal
2. Patient Age: 18 years and under 80 years
3. Intervention earlier in the mandible or thorax
4. A history of facial burn
5. Allergy tape
An Open-label, Multi-center Study Evaluating the Validity, Reliability, and Responsiveness of a New Female-specific Angina Questionnaire in Women With Chronic Angina Treated With Ranolazine Extended-release Tablets (CVT 3041)

According to the American Heart Association (AHA) 2011 update of heart disease and stroke statistics, more than 9 million adult patients in the United States (US) have angina. This update also notes that a study of 4 national cross-sectional health examination studies found that, among Americans 40 to 74 years of age, the age-adjusted prevalence of angina was higher among women than men. Per ACC/AHA guidelines, the goal of antianginal therapy is the complete or near complete elimination of anginal chest pain and a return to normal activities and functional capacity. However, evaluating angina and responses to antianginal therapy is often not straightforward. This is particularly true of female patients with angina. Because angina and response to antianginal therapy may differ in men and women, an instrument designed specifically to address symptomatology in women with angina could enhance our understanding and characterization of angina and responses to therapy in this population. The current study will evaluate the validity, reliability, and responsiveness of the newly developed Women's Ischemia Symptom Questionnaire (WISQ) based on changes in angina symptomatology in a female angina population treated with ranolazine, compared with the widely used Seattle Angina Questionnaire (SAQ).


Eligibility Criteria:
Inclusion Criteria:

* At least 3 months of documented history of stable angina or angina equivalents that is relieved by rest and/or sublingual NTG
* Taking antianginal therapy with beta-blockers, and/or dihydropyridine calcium antagonists, and/or long-acting nitrates for at least 4 weeks
* Mean angina frequency of ≥ 2 attacks per week
* Documented clinical evidence of ischemia

Exclusion Criteria:

* Clinically significant hepatic impairment
* Uncontrolled clinically significant cardiac arrhythmias or a history of ventricular fibrillation, torsades de points, or other life-threatening ventricular arrhythmias not associated with acute coronary syndrome
* Treatment with strong cytochrome P450 inhibitors including ketoconazole, itraconazole, clarithromycin, nefazodone, nelfinavir, ritonavir, indinavir, or saquinavir
* Prior treatment with ranolazine
* End-stage renal disease requiring dialysis
* Myocardial infarction or unstable angina
Driving Ability of Drug Dependant Patients in Maintenance Therapy

"Mobility" is a contributing factor in today's society. Drug dependence displays not only a medical but also an economic problem: Especially for an intended reintegration of a drug dependant patient in maintenance therapy the possession of a driving licence could be decisive for a job allocation and therefore the intended reintegration to society.

Subject of this study was to verify if patients under substitution therapy with R, S- Methadone, S- Methadone, Buprenorphine and Buprenorphine plus Naloxone are just as fit to drive a car as a non drug dependent person.

For this investigation we compared 121 drug dependent patients in stable maintenance therapy for a minimum of two years without consumption of any other psychotropic substances than their maintenance drug (including THC) with non- drug dependant subjects of the same gender, age and level of education.

This is the largest study on this topic worldwide. The neuro- cognitive working order was tested by means of the "Vienna Test System" an objective, reliable and valid test quantifying reaction time, attention efficiency, concentration, maximum resilience and orientation. Current use of any other psychotropic substance or alcohol just as any serious illness (including psychiatric diseases, except for an effectively treated depression) lead to exclusion from this study.


Eligibility Criteria:
Inclusion Criteria:

* Drug dependent patients in stable maintenance therapy for a minimum of two years without consumption of any other psychotropic substances than their maintenance drug (including THC)
* Written agreement on attending this study after full clarification
* majority

Exclusion Criteria:

* Patients, who do not approve or are not able to approve, to this study
* Patients, who are not legally competent
* Patients in emergency situations
* Patients under age
* Consumption of any other psychotropic substances than the maintenance drug
* Severe illnesses p.e. malignant diseases, serious psychiatric illness
Gypenosides Treatment for Optic Neuritis

The purpose of this study is to determine whether gypenosides are neuroprotective in patients with acute optic neuritis.


Eligibility Criteria:
Inclusion criteria

1. Male and female Chinese patients aged ≥18 to ≤60 years
2. Patients with a first episode of optic neuritis in the eye of interest
3. First symptoms of optic neuritis ≤28 days prior to the first administration of investigational product
4. Best corrected visual acuity in the eye of interest ≤0.8

Exclusion criteria

1. Pre-existing multiple sclerosis MS or NMO
2. Refractive media opacity
3. Hyperopia \>5 diopters, myopia \<-5 diopters, or astigmatism \>3 diopters
4. Active tuberculosis, hepatitis, renal insufficiency, uncontrolled hypertension, diabetes mellitus, infection with HIV or syphilis, or any other conditions potentially interfering treatment trial
5. Other autoimmune diseases (systemic lupus erythematosus, rheumatoid arthritis, etc)
6. Existing other retina or optic nerve diseases
7. Pregnant or females who plan to be pregnant during study
Study Evaluating Antibiotic Utilization Measures and Control of Extended-Spectrum-Lactamases (ESBLs)

* To determine the value of using piperacillin/tazobactam in reducing the cases of ESBL producing E. coli or K. pneumoniae colonization and infection.
* To determine the acquisition rate of ESBL producing E. coli or K. pneumoniae, both pre and post intervention in the selected medical centers.


Eligibility Criteria:
Inclusion Criteria:

* Patients admitted or transferred to the ICU/pulmonary/hematology units.
* Patients of either sex, 18 years of age or older

Exclusion Criteria:

* Pregnant and nursing women. Female of childbearing potential without using any birth control methods. Female of childbearing potential using oral contraceptives during study period. (Note: penicillin and beta-lactamase inhibitors may prevent oral contraceptives from working properly, increasing the chance of pregnancy).
* Patients who have the contraindications of using Tazocin (pipercillin/tazobactam)

Other exclusions apply.
Evaluating the Efficacy of Resveratrol Containing Mouthwash as Adjunct Treatment Periodontitis:

To evaluate the effectiveness of resveratrol mouthwash as adjunct to NSP treatment of periodontitis

* Measuring and comparing the efficacy of RV mouth wash in comparison with CHX and placebo mouth wash in improving the clinical periodontal parameters;
* Measuring the salivary cytokines (IL-6) before and after 4weeks of the use of RV mouth wash as adjunct to NSP treatment in comparison with other mouthwash by using enzyme-linked immunosorbent assay.
* Measuring the salivary RANKL before and after 4weeks of the use of RV mouth wash as adjunct to NSP treatment in comparison with other mouthwash by using enzyme-linked immunosorbent assay.
* Correlate the salivary cytokines IL-6 and salivary RANKL with clinical periodontal parameter and with each other.
* Evaluate the intervention by using Visual analog scale (VAS)- score-based questionnaire will be filled out by each participant at the end of the trial.

Eligibility Criteria:
Inclusion Criteria:

-

The inclusion criteria:

1. Participants need to be systemically healthy with age \> 18 years old.
2. Not taking antibiotic and anti-inflammatory drugs in the last three months.
3. At least 20 teeth should be present
4. Should have unstable periodontitis (PPD ≥ 5 or BOP at 4mm pocket)

The exclusion criteria:

1. Patients wearing fixed prosthesis (crowns, bridges or orthodontic appliances)
2. Those with chronic disease, immunocompromised patients, pregnant, on contraceptives or lactating women.
3. Those currently using any mouthwash.
4. Those on antibiotic therapy and anti-inflammatory medications during the study and in the last 3 months before the study.
5. Those having a history of hypersensitivity to any product used in the present study.
6. Those who are smokers or alcoholics.
7. Those who refuse to participate in the trial.

   -
Thrombolysis With rhPro-UK in 4.5-6 Hours After Acute Ischemic Stroke in a Double-blinded,Controlled Trial

This is a randomized,controlled, double-blinded, phase 3 clinical study to evaluate the efficacy and safety of recombinant human urokinase(rhPro-UK) versus basic treatment for patients with acute ischaemic stroke in 4.5-6 hours after stroke onset.


Eligibility Criteria:
Inclusion Criteria:

1. Ischemic stroke with symptoms of neurological deficits.
2. Aged 18 to 80 years,male or famale.
3. NIH Stroke Scale（NIHSS）scores of 4 to 25.
4. Treatment 4.5 to 6 hours after stroke onset.(Stroke onset time is defined as the last time a patient with no clinical neurological deficit,for patients who wake up with stroke symptoms, consider that stroke occurs when the patient begins to fall asleep).
5. The symptoms of stroke last at least 30 minutes without significant improvement before treatment.
6. CT showed negative or signs of early infarction.
7. Patients and/or their families are willing to participate in this study and agree to sign informed consent.

Exclusion Criteria:

1. Patients with premorbid modified Rankin Scale(mRS) score ≥2
2. CT showed multiple infarctions（low density\> 1/3 cerebral hemisphere）.
3. Transient ischemic attack.
4. Epileptic seizure when stroke onset.
5. Intracranial tumor, arteriovenous malformation and aneurysm.
6. Iatrogenic Stroke.
7. Thrombectomy is planned.
8. Cardioembolism and atrial fibrillation.
9. Myocardial infarction history within 3 months.
10. Severe cerebral trauma or stroke history within 3 months.
11. Blood pressure is still out of control after aggressive antihypertensive treatment.Uncontrolled blood pressure is defined as systolic blood pressure≥ 180mmHg or diastolic blood pressure≥100mmHg.
12. High density lesions (bleeding) and subarachnoid hemorrhage is revealed by emergency CT examination.
13. Active visceral hemorrhage.
14. Patients with intracerebral hemorrhage history.
15. Patients with diabetic retinopathy history.
16. Puncture in 1 week which can not be oppressed.
17. Major surgery or severe trauma within 2 weeks.
18. Intracranial surgery, intraspinal surgery or solid organ biopsy within 30 days.
19. Heparin treatment within 48 hours (APTT above normal upper limit).
20. Taking anticoagulant drugs orally, and PT \>15s or INR \>1.7.
21. High risk of acute hemorrhage include platelet count\<10\^9/L.
22. Taking thrombin inhibitors or factor Xa inhibitor with abnormal results of sensitive laboratory examination(e.g. APTT, INR, PLT, FIB、TT or appropriate Ⅹ a factor activity test, etc.).
23. Blood glucose \< 2.7 mmol/L or \> 22.2 mmol/L.
24. Pregnancy, lactating or menstrual women.
25. Patients who have difficulty swallowing and are unable to take medications orally.
26. Clinician thinks patient doesn't fit to participate in the test of other diseases or conditions.