cyrilzakka/clinical-trials huggingface dataset:
Vasoactive and Anti-inflammatory Effects of Prasugrel in Acute Coronary Syndrome

To test the vasoactive and anti-inflammatory effects of prasugrel in patients with acute coronary syndrome endothelial function -as a surrogate parameter of NO bioavailability- and different markers of inflammation, oxidative stress and platelet activation will be assessed in patients with unstable angina.

Trial Objectives To test the vasoactive and anti-inflammatory effects of prasugrel in patients with acute coronary syndrome, endothelial function -as a surrogate parameter of NO bioavailability- and different markers of inflammation, oxidative stress and platelet activation will be assessed in patients with unstable angina.

Trial Design Single center, double blind, double-dummy, randomized, parallel trial.

Endpoints

Primary Endpoint Assessment of endothelial function (FMD) via high-resolution ultrasound (Sonoline G50, 12 MHz linear array transducer, Siemens, Germany) by experienced sonographer.

Secondary Endpoints

* Non-invasive assessment of microvascular perfusion and oxygen saturation by laser Doppler perfusion imaging and tissue spectrometry (O2C, Lea Medizintechnik, Giessen, Germany)
* Determination of leukocyte activity: plasma MPO levels (ELISA), plasma elastase levels (ELISA)
* Assessment of platelet activity: plasma levels of sCD40 ligand (ELISA), RANTES (ELISA)
* Measurement of different oxidative stress markers: hsCRP (ELISA), CD40 ligand (ELISA), carbonylated proteins (ELISA), urinary 8-iso-PGF2α (gas chromatography mass spectrometry)
* Determination of platelet-leukocyte aggregates by fluorescent activated cell sorter (FACS)
* Assessment of platelet function (PADA-test)

Eligibility Criteria:
Inclusion Criteria:

* Acute coronary syndrome, unstable angina
* planned percutaneous coronary intervention
* Written informed consent

Exclusion Criteria:

* - Age \< 18 years or ≥75 years
* Body weight \< 60 kg
* STEMI, NSTEMI
* Cardiogenic shock at the time of randomization
* Refractory ventricular arrhythmias
* Congestive heart failure (NYHA IV)
* Increased risk of bleeding
* Active internal bleeding or history of hemorrhagic diathesis
* History of TIA, ischemic or hemorrhagic stroke
* Intracranial neoplasm, aneurysm and arteriovenous malformation
* INR \> 1.5 at screening
* Platelets \< 100,000/ml
* Anemia (Hb \< 10 g/dl) at screening
* One or more doses of a thienopyridine 5 d or less before PCI
* Oral anticoagulation which cannot be safely discontinued for the duration of the study
* One or more doses of a thienopyridine 5 d or less before PCI
* Treatment within the last 30 d with an investigational drug or are presently enrolled in another drug or device study
* Women who are known to be pregnant, have given birth within the past 90 d, or are breast-feeding
* Concomitant medical illness that in the opinion of the investigator is associated with reduced survival over the expected treatment period
* Known severe hepatic dysfunction
* Any condition associated with poor treatment compliance, including alcoholism, mental illness, or drug dependence
* Intolerance of or allergy to aspirin, ticlopidine, or clopidogrel
Clinical Course of Interstitial Lung Diseases: European IPF Registry and Biobank

Born out of the European Union 7th Framework Programme funded project European IPF Network (eurIPFnet), the European IPF Registry (eurIPFreg) has become Europe's leading database of longitudinal data from IPF patients, including control groups of patients with other lung diseases. The registry was initiated with the intention of creating a permanent and continuously growing record of well defined data on IPF in Europe, in order to increase the chances of finding better treatment options for this devastating disease.

Clinical colleagues who would like to actively participate (both in terms of patient recruitment and data analysis) are invited to contact us (http://www.pulmonary-fibrosis.net/).

The group's work aims to foster research on Idiopathic Pulmonary Fibrosis (IPF), the most aggressive form of an Idiopathic Interstitial Pneumonia (IIP). Within the eurIPFreg we, the eurIPFreg steering committee and a growing number of external site investigators, aim to describe the natural course of IPF and other IIPs, to identify risk factors that are associated with the evolution of the disease and to sample biomaterials that may serve as underlying basis for translational research activities.

IPF and non-specific interstitial pneumonia (NSIP), as well as the other entities of IIPs (cryptogenic organizing pneumonia, COP; desquamative interstitial pneumonia, DIP; respiratory bronchiolitis interstitial lung disease, RB-ILD; lymphoid interstitial pneumonia, LIP; acute interstitial pneumonia, AIP) are frequently progressive, fibroproliferative diseases of unknown etiology, affecting the lung parenchyma. Patients with IPF have the most devastating prognosis within the group of IIPs, with a median survival rate of 2-3 years.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent signed

Exclusion Criteria:

* No informed consent signed
Sevoflurane as an Anesthetic During Dilation and Evacuation Procedures

Sevoflurane is an FDA-approved anesthetic drug commonly used for anesthesia during second trimester abortion procedures. It has a few advantages, including ease of use by the anesthesia provider. However, the literature suggests that when used in doses higher than those used at Oregon Health \& Science University (OHSU) and Lovejoy, it is associated with an increase in the risk of bleeding. The investigators study aims to test whether the lower dose used at OHSU and Lovejoy during second trimester abortion procedures causes any difference in blood loss, when compared to similar abortion procedures for which this drug is not used.

This study seeks to examine the bleeding complications associated with use of sevoflurane in general anesthesia regimens for second trimester abortion procedures and assess anesthesia providers' use and beliefs regarding possible risks associated with newer inhalational agents such as sevoflurane in this setting. Participants' anesthesia will either be intravenous (IV) propofol, IV midazolam, IV fentanyl and nitrous oxide or this same regimen combined with sevoflurane during maintenance of anesthesia. Procedural outcomes, specifically those related to bleeding complications, including need to intervene for excess blood loss, will be recorded and analyzed to establish if such a relationship between use of sevoflurane and excess blood loss exists.

Eligibility Criteria:
Inclusion Criteria:

* Voluntarily requesting pregnancy termination
* Estimated gestational age of 18 weeks - 23 weeks, 6 days gestational age as calculated by fetal biparietal diameter on clinic ultrasound.
* Be able and willing to sign an informed consent and agree to terms of the study

Exclusion Criteria:

* Known severe maternal respiratory disease or upper respiratory infection or sinus blockage
* Anticoagulation use: within 24 hours if Lovenox, or within 12 hours if heparin, (Must have a documented normal international normalized ratio (INR) prior to procedure if on anticoagulation)
* Multiple pregnancy
* Fetal demise, if more than 2 weeks difference exists between known gestational age (by previous US dating) and gestational size on current ultrasound.
* Known allergy/sensitivity to sevoflurane or any other inhaled anesthetic agents
Pharmacosurveillance Data Repository of Patients With and Without History of Anaphylactic Reactions Subsequent to Xolair Dosing

This study will establish a clinical data and serum repository of anaphylaxis cases associated with Xolair administration and control patients who have received Xolair without associated anaphylaxis. This is an observational repository and not an investigational clinical trial. Associated with the repository is an optional skin testing substudy.


Eligibility Criteria:
Inclusion Criteria for Cases:

* Confirmed anaphylaxis based on Sampson criteria subsequent to Xolair

Inclusion Criteria for Controls:

* At least 1 patient control among 4 controls who discontinued Xolair for at least 16 weeks but not more than 18 months at enrollment
* At least one dose of Xolair in the 18 months before the date of the case event (index date)
* No prior anaphylaxis or other hypersensitivity reaction subsequent to Xolair dosing, including any reactions to its components
Validation of the MiCK Assay

Testing Mayo Clinic cancer patients with the results being correlated with prior patient therapy, performance status, and extent of disease.

This study will be conducted in two phases.

During the Feasibility Phase, specimens from any tumor will be sent to the central DiaTech MiCK assay laboratory to determine the ease of sample acquisition, processing, transport, and assay interpretation.

Once DiaTech has completed analyses for the feasibility phase specimens and has confirmed that the sample acquisition, processing, transport, and assay interpretation are appropriate, we will proceed with the Demonstration Phase.

During the Mesothelioma Demonstration Phase, 20 mesothelioma samples will be assayed and the results will be correlated with prior patient therapy, performance status, and extent of disease.

Eligibility Criteria:
Inclusion Criteria:

* 20 subjects diagnosed with mesothelioma and 10 diagnosed with any malignancy.

Exclusion Criteria:

* patients that a sample cannot obtained for testing.
Exercise in Severe Mental Illness. The PsychiActive Project 2.0

The purpose of this randomized controlled trial is to study the feasibility, adherence and effects of two exercise interventions on body weight, body composition, anthropometric and fasting blood measures, physical fitness, quality of life, and lifestyle habits in patients with severe mental illness.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of psychiatric disorder (ICD-10).
* Stabilized antipsychotic medication during the last month.

Exclusion Criteria:

* Clinical instability.
* Substance abuse.
* Comorbidities contraindicating.
Aesthetic Performance of Bioactive Injectable Composite Versus Universal Injectable Composite in Class V Cavities

Using bioactive injectable resin composite in anterior class v carious lesions can provide better aesthetic outcome and marginal integrity by releasing multiple ions, including fluoride. This offers better marginal integrity due to presence of S-PRG fillers


Eligibility Criteria:
Inclusion Criteria:

1. Age 20-60 years.
2. Co-operative participants approving to participate in the study.
3. Male or female patients.
4. Medically free participants.
5. Moderate or high caries risk participants.

Exclusion Criteria:

1. Systemic disease or severe medical complications.
2. Participants with a history of allergy to any component of restorations will be used in the study.
3. Lack of compliance
4. Evidence of severe bruxism, clenching, or temporomandibular joint disorders or bizarre habits
The WEB®-IT China Clinical Study

This trial is a prospective, multicenter, single-arm confirmatory clinical trial. The study is to confirm the safety and effectiveness of the WEB Aneurysm Embolization System demonstrated in the US WEB-IT Study for the treatment of intracranial wide-neck bifurcation aneurysms. The study's primary endpoints include a primary effectiveness endpoint and a primary safety endpoint. The study device must meet both endpoints. The primary effectiveness endpoint is adjudicated by an independent third party core lab.


Eligibility Criteria:
Inclusion Criteria:

* Patient whose age ≥ 18 and ≤75 years old
* Patient must have a single ruptured or unruptured IA(intracranial aneurysm)requiring treatment
* Patient must sign and date IRB/EC approved written informed consent prior to initiate of any study procedures

Exclusion Criteria:

* Patient has an IA with characteristics unsuitable for endovascular treatment
* Patient has stroke-in-evolution within the prior 60-days
* Patient has had an SAH(subarachnoid hemorrhage) from a nonindex IA or any other intracranial hemorrhage within 90 days
* Patient's index IA was previously treated
* Patient is pregnant
Simultaneously Targeting Obesity and Pain: The STOP Trial

The purpose of this study is to determine whether an integrated behavioral treatment approach can help overweight or obese individuals who also have chronic pain reduce their weight and manage their pain symptoms. The goal of this research is to develop better treatments for individuals with chronic pain and overweight or obesity. All participants in this study will receive treatment for weight management and/or pain symptoms. Participants will be assigned at random (like we picked it blindly out of a hat) to receive either: (1) Standard behavioral treatment for weight loss; or (2) Standard behavioral treatment for pain management; or (3) Integrated behavioral treatment for weight loss and pain.


Eligibility Criteria:
Inclusion Criteria:

* Adults aged ≥ 18
* Body mass index (BMI) ≥ 25
* Chronic, non-cancer pain (pain at a level ≥ 4 on a scale of 0-10 on a majority of the days for 6 months or more prior to study participation)

Exclusion Criteria:

* Have an unstable medical or psychiatric condition
* Meet criteria for current substance abuse or dependence
* Meet the criteria for bulimia
* Non-fluent in spoken or written English
* Currently pregnant, pregnant within the past 6 months, trying to get pregnant in the next 3 months
* Demonstrate significant cognitive or sensorimotor impairment precluding treatment engagement
* Already participating in a similar structured diet or exercise program or pain self-management program or plans to begin such a program outside the study during the next month
* At risk for significant adverse cardiovascular events with moderate activity
* Plans to relocate within the upcoming 12 months
The Inter-rater Reliability of the Turkish Version of Aphasia Rapid Test for Stroke

The Aphasia Rapid Test (ART) is a bedside aphasia screening test developed originally in French. The purpose of this study is to assess the inter-rater reliability of the Turkish version of the ART in stroke patients.

The Aphasia Rapid Test (ART) was developed and validated originally in French to evaluate language skills in post-stroke patients (Azuar et al., 2013). It is a 26-point scale that takes less than 3 minutes to administer. The simplicity of the ART allows it be used bedside in acute post-stroke patients with little to no training needed. The items needed to administer the ART are also easy to access in healthcare settings (e.g., watch, pen, doctor's coat). Although the ART is not a diagnostic test, it is beneficial for tracking progress and determining prognosis in stroke patients.

The original ART was designed similar to the NIH Stroke Scale (NIHSS), a widely-used test in stroke patients. The NIHSS which assesses many areas of functioning (level of consciousness, gaze, visual ability, facial palsy, motor and sensory ability, limb ataxia, language, dysarthria, and extinction and inattention) was chosen because of its sensitivity to early changes in neurological status and high prognostic accuracy (http://www.nihstrokescale.org). The ART is an expanded version of the language section of the NIHSS. The total possible points on the ART is 26, which indicates the highest level of impairment. The test begins with the patient being asked to follow two one-step commands (up to two points each), a complex command (up to 3 points), repeat three nouns (up to 6 points), repeat a simple sentence (up to 2 points), and name three simple objects (up to 6 points). The next item requires a rating of dysarthria by the examiner (up to 3 points). On the final item, the patient is asked to name as many animals as they can think of in one minute (up to 4 points). With the exception of items 1a, 1b, and 6, there are no time restrictions on the test.

The purpose of the present study is to translate the original ART into Turkish to provide an efficient method for the evaluation of language skills in post-stroke Turkish-speaking patients and to assess its inter-rater reliability.

Eligibility Criteria:
Inclusion Criteria:

* Left MCA infarct due to CVA
* Right hand dominant
* Turkish as first language
* CVA within the last 10 days

Exclusion Criteria:

* Right or bilateral brain lesion
* Previous stroke
* Psychiatric disorder
* Other neurological disorder
* Cognitive impairment
* Endotracheal entubation prohibiting responses to test
An Effectiveness and Safety Study Comparing Acetaminophen (3900 mg/Day) to Ibuprofen (1200 mg/Day) in the Treatment of Post-Race Muscle Soreness.

The purpose of this study is to compare the effectiveness and safety of acetaminophen extended release caplets and ibuprofen in relieving the muscle soreness that occurs after a marathon.

The objective of this randomized, double-blind study is to compare the effectiveness and safety of acetaminophen extended release caplets and ibuprofen in relieving the muscle soreness that occurs in subjects who complete a marathon. Subjects are randomized to receive acetaminophen extended release caplets, 3900 mg/day (two 650 mg caplets taken three times a day, for five days) or ibuprofen caplets, 1200 mg/day (two 200 mg caplets taken three times a day, for five days). The primary measurement of efficacy is the average change in muscle soreness from baseline for both the morning and evening assessments. Safety assessments consist of monitoring adverse events, and a physical examination including vital signs, weight, a review of concomitant medications, and a urine pregnancy test for female subjects. Two hypotheses are examined in a step-down approach. The first hypothesis is that acetaminophen extended release is not inferior to ibuprofen in relieving the muscle soreness that occurs after a marathon. If acetaminophen extended release is not inferior to ibuprofen in relieving the muscle soreness that occurs after a marathon, the second hypothesis is that acetaminophen extended release (3900 mg/day) is superior to ibuprofen (1200 mg/day) in relieving the muscle soreness that occurs after a marathon. Two acetaminophen 650 mg extended release caplets, taken by mouth, three times a day for five days or two ibuprofen 200 mg caplets, taken by mouth, three times a day for five days.

Eligibility Criteria:
Inclusion Criteria:

* Patients must complete the marathon
* be able to swallow the study medication
* comply with study requirements regarding the use of any other pain medications before, during or after the marathon
* rate their muscle soreness on the evening after the marathon as at least a 4, on a zero-to-ten point scale
* if female, must not be pregnant or breastfeeding, and must be using an acceptable form of contraception

Exclusion Criteria:

* Previous diagnosis of osteoarthritis requiring pain medication therapy
* currently have a major medical illness
* have a history of cardiovascular disease, heat injury (heat exhaustion or heat stroke) or collapse during a running or endurance event
* known hypersensitivity to acetaminophen or ibuprofen
Epidemiology of Klebsiella Pneumoniae in China

Klebsiella pneumoniae is one of the most common pathogens causing both community-onset and nosocomial infection. More worse, the emergency of Carbapenem-Resistant Klebsiella pneumoniae (CRKP) had cause the clinical therapy be very difficult. However, there is not much empirical data as to the prevalence, risk factors, characteristics,outcomes and the rationality of the current therapy for the Klebsiella pneumoniae infection in China.Thus, the study was aimed to investigate the epidemiology and risk factors, characteristics, outcomes and the rationality of the current therapy for the Klebsiella pneumoniae infection in China.

All the patients with culture positive of Klebsiella pneumoniae were screened and reported to the the clinical doctors and confirmed by them. And the clinical characteristics of the patiens, such as baseline data, outcomes etc, were recorded. Finially, to find the prevalence, risk factors, characteristics, outcome and the rationality of the current therapy for the Klebsiella pneumoniae infection in China.

Eligibility Criteria:
Inclusion Criteria:

- new confirmed community-onset or noscomial infection of Klebsiella pneumoniae infection

Exclusion Criteria:

* Age\<18, or \>85 years old; Mixed infection of Klebsiella pneumoniae and other microbes
Study to Assess the Benefit of Midodrine in the Treatment of Patients With Neurogenic Orthostatic Hypotension

The purpose of this clinical study is to evaluate the clinical effect of midodrine hydrochloride (ProAmatine®) compared to placebo in patients with orthostatic hypotension by measuring the time to onset of near syncopal symptoms and assessing several cardiovascular measurements, such as heart rate, blood pressure, and ECG, using the tilt table test.


Eligibility Criteria:
Inclusion Criteria:

* The male or female subjects must be 18 years of age or older and ambulatory. (Subjects must not require assistance with a walker or wheelchair to perform regular daily activities at all times.)
* Women of childbearing potential must have a negative serum beta HCG pregnancy test at screening and baseline.
* The subject has been diagnosed with symptomatic orthostatic hypotension due to Parkinson's disease, multiple system atrophy, pure autonomic failure or autonomic neuropathy (i.e. neurogenic orthostatic hypotension).
* The subject manifests one of the following symptoms while standing or has a history of one of the following when not treated for orthostatic hypotension: dizziness, lightheadedness, feeling faint or feeling like they may black out.
* The subject is willing and able to undergo the procedures required by this protocol including morning office visits, assessment completion, protocol compliance and participation in the wash-out period.
* The subject has signed an Institutional-Review-Board approved written informed consent form prior to any study procedures taking place.

Exclusion Criteria:

* The subject is a pregnant or lactating female.
* The subject has pre-existing sustained supine hypertension greater than 180 mm Hg systolic and 110 mm Hg diastolic.
* The subject is taking medications such as vasodilators, pressors, diuretics, ACE inhibitors, angiotensin receptor blockers, beta-blockers, combined alpha and beta-blockers, MAOI's, herbals or specific mixed effect medications.
* The Principal Investigator deems any laboratory test abnormality clinical significant.
* The subject has a diagnosis of any of the following disorders at the time of screening: pheochromocytoma; cardiac conditions including: congestive heart failure within the previous 6 months, myocardial infarction within the previous 6 months, symptomatic coronary artery disease, history of ventricular tachycardia, or uncontrolled cardiac arrhythmias; thyrotoxicosis; uncontrolled diabetes mellitus (uncontrolled defined as a HgbA1c greater than or equal to 10%); history of cerebrovascular accident, transient ischemic attack (TIA) or symptomatic carotid artery stenosis within the previous 6 months; history of coagulopathies; pulmonary hypertension; severe psychiatric disorders; renal failure (Creatinine equal to or greater than 2 times the upper limit of normal)
* The subject has a concurrent chronic or acute illness, disability, or other condition that might confound the results of the tests and/or measurements administered in this trial, or that might increase the risk to the subject.
Spanish Natural History Study for LAMA2 Muscular Dystrophy

The objective of this natural history study is to comprehensively characterize the disease progression and clinical features of LAMA2-related dystrophies (LAMA2-RD) in the pediatric population. The study aims to establish a well-defined cohort of patients in Spain, enabling long-term follow-up and facilitating recruitment for future clinical trials.


Eligibility Criteria:
Inclusion Criteria:

* All patients with compatible clinical presentation and identification of 2 pathogenic variants in LAMA2, or muscle biopsy with decreased laminin alpha2 protein and at least one pathogenic variant
* Signed informed consent by the Legal Authority Responsible and/or assent by the subject (starting from 6 years old)