cyrilzakka/clinical-trials huggingface dataset:
Observational Study to Evaluate the STALIF® C FLX, STALIF® M FLX, STALIF® L FLX Cages and FORTOS-C®

Post-operative clinical outcome data on the devices used to treat spinal diseases are collected and evaluated in order to analyze the safety and performance of the implants used.


Eligibility Criteria:
Inclusion Criteria:

- Indications according to IFU

Surgical implantation of STALIF® C or M FLX device for 1 or 2 levels between:

* STALIF® C FLX: C2-T1 (cervical)
* STALIF® M FLX: L2-S1 (lumbar)
* STALIF® L FLX: L2-L5 (lumbar)

Surgical implantation of FORTOS-C® for the fusion of up to 3 levels between:

* FORTOS-C®: C2 - T1 (cervical)
* Age: ≥ 21 years
* For the evaluation of the questionnaires (NDI or ODI, VAS neck and VAS arm or VAS leg and VAS back), only patients with the questionnaire available at the time of admission (pre-op) and at least at 12-months FU will be included

Exclusion Criteria:

* Relative and absolute contraindications according to IFU
Markers of Vascular Aging and Coronary Syndrome

Atherosclerosis and aging are associated to the raise of biochemical alterations of proteins grouped under the name of " non-enzymatic post-translational modifications ". They often correspond to the irreversible binding of glucose or other oses (glycation) or urea derivatives (carbamylation) on proteins and lead to the formation of complex compounds (post-translational modifications derived products, PTMD) that can accumulate in tissues and be responsible for deleterious effects. The specific role of these compounds in the pathophysiology of aging and atherosclerosis remains unknown, as are the molecular and cellular mechanisms implicated.

This project is based on the hypothesis that non-enzymatic post-translational modifications may cause changes in the genesis of complication of coronary atherosclerosis and that PTMD could therefore constitute relevant biomarkers in this specific clinical situation.

To explore these potential new biomarkers, the investigators designed a study in patients having experienced an acute coronary syndrome and followed during a year. The concentrations of PTMD assayed at 0, 1, 3, 12 months, will be correlated to clinical (severity and evolution) and paraclinical (cutaneous autofluorescence) data and the effect of cardiac rehabilitation will be assessed.

This should help to identify new (and non-traditional) biomarkers of coronary heart disease and determine some of the implicated pathophysiological mechanisms.


Eligibility Criteria:
Inclusion Criteria:

* acute coronary heart syndrome
* included during hospitalization, usual cardiologic follow-up planned in Reims university hospital

Exclusion Criteria:

* \<18yo
Alzheimer's Disease Imaging With PET/MRI - Beta-amyloid

The early detection of a preclinical AD or early stage of AD with amyloid imaging could improve the diagnosis and provide knowledge for better therapeutical approach by combining the best of imaging: structural MR sequences and newly FDA-approved biomarker for amyloid PET imaging, all these two techniques with their strengths in one machine.

Specific Aims and Hypotheses can be summarized as follows:

1. To assess image quality and diagnostic performance of 18F-florbetapir (AMYVID) PET/MRI, including direct comparison to corresponding PET/CT images of the same patients.
2. To evaluate the incremental value of using 18F-florbetapir (AMYVID) in addition to 2-\[F-18\]-fluoro-2 deoxy-D-glucose (FDG) versus FDG alone. Does quantification of plaque burden correlate with degree of neuronal degeneration as depicted by FDG as well as with clinical severity?
3. To determine plaque burden quantitatively with 18F-florbetapir (AMYVID) in PET (form PET/CT and from PET/MR) using novel software developed specifically for these brain application; Computer-Aid Diagnosis for Dementia for amyloid imaging - CAD4D-amyloid


Eligibility Criteria:
Inclusion Criteria:

* Patients with suspected AD, MCI and other cognitive impairment will be referred by their neurologist to have a clinical ordered FDG-PET/CT and clinically indicated AMYVID in addition,
* Patients equal to or greater than 21 years old,
* Signed informed consent by patient or legal guardian,
* Physically capable to cooperate.

Exclusion Criteria:

* Subjects who do not meet the above mentioned inclusion criteria,
* Subjects unwilling or unable to sign the informed consent form,
* Subjects with any significant psychiatric or neurologic disorder or disease other than dementia expected to interfere with the study,
* Subjects unable to undergo MR scanning due to exclusion via UHCMC MR restrictions (e.g. certain implanted metallic or electronic devices),
* History of adverse events related to a previous MR or PET/CT,
* Pregnant women,
* Minors.
Respiratory Volume Measure Using ExSpiron 1Xi

The purpose of this study was to determine the accuracy of one-time respiratory volume measured by RVM(Respiratory Volume Monitor) compared to the one-time respiratory volume measured by mechanical ventilation in post-operative ICU patients.

The purpose of this study was to determine the accuracy of one-time respiratory volume measured by RVM(Respiratory Volume Monitor) compared to the one-time respiratory volume measured by mechanical ventilation in post-operative ICU patients.

In addition, the investigators investigated the decrease in respiratory volume in opioid infusion after ventilator weaning in this patient, and to measure the one-time respiratory volume change by RVM during deep breathing induction using Inspirometry exercise.

Eligibility Criteria:
Inclusion Criteria:

* An adult patients ( ≥ age 19)
* patients who receive mechanical ventilation in the ICU of the Severance Hospital after surgery and plans to wean the mechanical ventilation within 3 days.

Exclusion Criteria:

* severe respiratory illness patients (pneumothorax, chest tube intubation status, severe restrictive respiratory disease, unilateral lung ventilation, lung transplantation status, chronic restrictive respiratory disease, hydrothorax, diaphragmatic movement disorder)
* If the candidate can not understand and carry out the experiment contents and process
To Evaluate the Safety in Patients Taking Duloxetine for Stress Urinary Incontinence

This is an on-going study to evaluate the long-term safety and maintenance of effect of duloxetine in patients suffering with stress urinary incontinence.


Eligibility Criteria:
Inclusion Criteria:

Have had symptoms of SUI for at least 3 months prior to study entry.

Have urine leakage most often associated with activity (such as coughing, sneezing, exercise).

Ambulatory and able to use a toilet independently and without difficulty.

-

Exclusion Criteria:

Subjects who participated or were discontinued from any previous studies investigating duloxetine.

Use of excluded medications within 14 days prior to study entry or at any time during the study.

Subjects who currently have or have had a history of urogenital cancer.
Observational Study Evaluating the Effectiveness of Drug Concentration to Predict the Recapture of Response in Crohn's Disease Patients With Loss of Response ( PRADA )

This is a multi-center study that explores the relationship between recapture of response with escalation to weekly adalimumab and trough adalimumab concentration before escalation in patients experiencing lack of response (LOR).


Eligibility Criteria:
Inclusion Criteria:

* Documented diagnosis of Crohn's Disease.
* Treatment with adalimumab, for a minimum of 16 weeks, as per clinical practice, at a dose of 160 mg at week 0, 80 mg at week 2, and then 40 mg q2w with a documented response as defined by the investigator.
* Current evidence of active inflammatory disease/LOR defined as the presence of active inflammation (confirmed with a CRP ≥ 5 mg/L and/or a fecal calprotectin ≥ 250µg/g.
* Ability of subject to participate fully in all aspects of this clinical trial.
* Written informed consent must be obtained and documented.

Exclusion Criteria:

* Primary non-responders to 16 weeks of adalimumab therapy.
* Received any investigational drug within the 16 weeks of adalimumab therapy.
* Serious underlying disease other than CD that, in the opinion of the investigator, may interfere with the subject's ability to participate fully in the study.
* History of alcohol or drug abuse that, in the opinion of the investigator, may interfere with the subject's ability to comply with the study procedures.
* Stools positive for Clostridium difficile.
* Pregnant or lactating women.
* Current enrolment in any other interventional research study.
* Presence of perianal or abdominal abscess.
The Reliability and Validity of the Functional Reach Test in Patients With Multiple Sclerosis

Loss of limits of stability ability is one of the major components of balance dysfunction in MS. The functional reach test is quick and clinically available tool for assessing limits of stability but reliability and validity of this test has not yet been systematically examined in people with Multiple Sclerosis.The aim of the study is to investigate reliability and validity of the functional reach test in patients with Multiple Sclerosis.

At baseline, the functional reach test, limits of stability test by using Biodex Balance System, Berg Balance Scale, four step square test, and timed up and go test was applied to the patients with Multiple Sclerosis. The functional reach test was repeated after seven days from the first application to evaluate its reliability.

Eligibility Criteria:
Inclusion Criteria:

* at least 18 years,
* neurologist-diagnosed Multiple Sclerosis,
* Expanded Disability Status Scale (EDSS) score \< 7,
* able to walk 20 m with or without aids,
* no MS exacerbation within the last 2 months,
* use of stable medication in the last 2 months.

Exclusion Criteria:

* other neurologic disorder,
* pregnancy,
* orthopedic problems affecting gait and stance,
* visual, auditory, orientational problems that could affect study results,
* cardiovascular, pulmonary, and humoral disease.
Evaluation of Soybean Peptides Product on Regulation of Blood Pressure Effect in Humans

This is the report to assess supplementation with soybean peptides on blood pressure among people with mild hypertension. Overall, soybean peptide consumption for 8 weeks could successfully reduce mean diastolic and systolic BP through the suppression of Angiotensin-converting enzyme (ACE) linked to downstream suppression of angiotensin II formation, which further decreases the sympathetic outflow that leads to hypertension.

This is the report to assess supplementation with soybean peptides on blood pressure among people with mild hypertension. Thirty subjects with systolic blood pressure (SBP) between 120 and 159 mm Hg and/or diastolic blood pressure (DBP) between 80 and 99 mm Hg were randomized to ingest 2 bags of soybean peptides or placebo per day for 8 weeks of a stage. Anthropometric measurements (blood pressure, body weight, body fat) and blood biochemical markers including fasting blood glucose (FBG), albumin, total cholesterol (TC), triglyceride (TG), HDL-C, LDL-C, creatinine (Cr), blood urea nitrogen (BUN), AST, ALT) were examined every four weeks.

Eligibility Criteria:
Inclusion Criteria:

* Eligible subjects were untreated hypertensive men or women aged between 20 and 80 years old with SBP between 120 and 159 mmHg and/or DBP between 80 and 99 mmHg as measured in a sitting position

Exclusion Criteria:

* Subjects were excluded if they had a history of major cardiovascular disease or severe liver dysfunction;
* Diastolic blood pressure ≥ 100 mmHg or Systolic blood pressure ≥ 160 mmHg;
* Alcoholic;
* US-controlled diabetics;
* Stoke in past one year;
* Mental diseases or melancholia;
* Pregnancy or breast-feeding a child;
* Renal dysfunction;
* Allergic to Soybean peptides.
Painted Playgrounds: Aim 2: Assessments

The Painted Playgrounds Aim 2 (Assessment) project will examine the effects of a stenciling intervention aimed at increasing physical activity and improving fundamental motor skill functioning of preschool aged children. 72 children from local licensed childcare centers will participate in individual assessments at baseline and follow-up 6-8 weeks later. Assessments include height/weight, surveys and wearing a physical activity monitor (accelerometer) for 7 days. A parent/legal guardian will provide consent for their child to participate and will also complete a brief survey about their child's lifestyle and habits.


Eligibility Criteria:
Inclusion Criteria:

* A child who attends a childcare center enrolled to Aim 1.
* A child who is ≥ 3 years and ≤ 6 years old
* Your child will continue to attend this same childcare center for the duration of the study.

Exclusion Criteria:

• Parent/legal guardian is unwilling to provide written informed consent
A Study on the Effects of Interventional Therapy in Patients With Lower Extremity Arterial Occlusive Disease and Its Risk Factors(EILRF)

Along with the improvement of living standard, the prevalence of Lower extremity arterial occlusive disease (LEAOD) is also increasing, which has become an important cause of lower extremity amputation and greatly affected the patients' life quality. Currently, percutaneous transluminal angioplasty (PTA), including balloon dilatation and stent implantation, has been regarded as the most widely applied and accepted treatment for LEAOD. The therapeutic effects of lower extremity interventional treatment, varied in different reports. It was reported that the therapeutic effects were influenced by some traditional risk factors, including age, gender, smoking, and so on. More risk factors are still unknown. The difference of therapeutic effects, the endpoint events were compared between interventional and conventional treatment group to analyze the effect of interventional treatment on LEAOD and explore its risk factors.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, age between 40-90 years old.
* Ankle-brachial index(ABI)\<0.9.
* Lower extremity arterial CT shows that the arterial stenosis\>50%

Exclusion Criteria:

* Type 2 diabetes with acute complications.
* Type 1 diabetes.
* Cerebrovascular diseases in the last 3 months.
* Cardiovascular diseases (myocardial infarction, angina, cardiac failure) in the last 3 months.
* Hemorrhagic disease.
* Hypohepatia (AST or AST is twice higher than the upper limit) or cirrhosis, hepatic encephalopathy.
* History of dialysis.
* Chronic obstructive pulmonary disease (COPD), chronic respiratory failure or hypoxemia.
* Acute infections, tumor, severe arrhythmia, mental disorders, alcohol or medicine addiction.
* Fertile woman without contraceptives.
* Allergic to iodine.
* Unable to understanding and follow the study protocol orientations.
Efficacy of Ultrasound-Guided Local Anesthetic Injection Into or Around the Sciatic Nerve for Lower Limb Anesthesia

This study was designed to assess whether the injection of local anesthetic into the nerve (intraneural), as opposed to around it (perineural), requires a shorter time to develop surgical anesthesia of the lower leg.

The investigators will compare the two types of injection using the same drug, so as to determine if there is an actual difference onset time. They will also examine the overall success rate of either kind of sciatic nerve blocks as the sole anesthetic for non-emergent orthopedic surgery.

The safety of these procedures will be examined by in-hospital and phone-call follow-up contacts.

This will be a randomized, controlled, patient- and observer-blinded trial assessing block characteristics after intra- or perineural injection of ropivacaine for subgluteal sciatic nerve blocks performed for elective surgery of the lower limb.

Eligibility Criteria:
Inclusion Criteria:

* Undergoing non-emergent orthopedic procedure of knee, leg, foot with thigh tourniquet
* ASA Physical Status Class I-III
* Consenting to surgery under peripheral nerve block anesthesia (sciatic + femoral/saphenous block)

Exclusion Criteria:

* Unable to understand or communicate for the purpose of the study
* Exhibiting any neurological disturbance of the ipsilateral lower extremity
* Inability to satisfactorily image the sciatic nerve in the opinion of the attending anesthesiologist
Bioequivalence Study Between Two Oral Formulations of Famotidine Tablets Under Fasting Conditions

Compare the rate and extent of absorption of famotidine 40 mg tablets, administered as 1 x 40 mg tablet under fasting conditions.


Eligibility Criteria:
Inclusion Criteria:

* healthy men or women 18 years of age or older
* body mass index below 30.0 kg/m2
* willing to participate and sin a copy of the informed consent form

Exclusion Criteria:

* recent history of drug or alcohol addiction or abuse
* pregnant or lactating women
* history of allergic response to heparin, famotidine, other H2-receptor antagonists, or other related drugs
* evidence of a clinically significant disorder or whose laboratory results were deemed to be clinically significant
* recipient of any drugs as part of a research study within 30 days prior to study dosing
Effect of Alendronate on Bone in People With Chronic Spinal Cord Injury (SCI) Previously Treated With Teriparatide

The purpose of this study is to determine if a year of alendronate treatment will maintain or increase bone mass density (BMD) compared to baseline BMD values in people with chronic spinal cord injury (SCI).

This study will also investigate 1) if alendronate therapy will increase bone strength in people with chronic SCI, 2) the number of participants with adverse events from alendronate, and 3) the effects of alendronate on serum markers of bone metabolism.

This extension study will enroll individuals who have completed treatment in the parent protocol "Effect of Teriparatide, Vibration and the Combination on Bone Mass and Bone Architecture in Chronic Spinal Cord Injury" or in the teriparatide extension protocol. This study will allow those individuals who previously received teriparatide to be treated for a year with alendronate to maintain any bone they may have gained and to possibly increase bone mass further. Termination of teriparatide is followed by bone loss if anti-resorptive therapy is not initiated, so this approach is optimal for continued treatment of the current group of participants.

Eligibility Criteria:
Inclusion Criteria:

* Prior enrollment in protocol "Effect of Teriparatide, Vibration and the Combination on Bone Mass and Bone Architecture in Chronic Spinal Cord Injury", (NCT01225055).
* Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy.
* Ability to understand and the willingness to sign a written informed consent.

Exclusion Criteria:

* Individual with renal insufficiency (calculated creatinine clearance \< 30 ml/min).
* Individuals who are not able to sit or stand upright for at least 30 minutes after taking their medication.
* Individuals with poor dental hygiene.
* Individuals with esophageal abnormalities.
* Individuals who are not able to tolerate alendronate treatment.
* Individuals who will not be able to return for all study visits.
* Patients may not be receiving any other investigational agents.
* Other medical conditions that in the opinion of the investigator would preclude the subject from completing the study
Comparison of Complement Factors and Genetic Polymorphisms of AMD Between Patients With Systemic Lupus Erythematosus (SLE) With and Without Retinal "Pseudo-drusen-like" Deposits: Case-control Study (PL-AMD)

The rationale of this research is to determine if patients with lupus and presenting retinal "pseudo-drusen-like" deposits have genetic and complement-related similarities with AMD patients.

Based on the results obtained, this study could lead to future research that could better target the treatment of patients with lupus or patients with AMD (Age related Macular Degeneration).

The primary objective is to check if patients with lupus, treated or not with antimalarial drugs, with "pseudo-drusen-like" deposits have a different complement profile (functional exploration of complement, complement factors, genetic complement polymorphisms involved in AMD) compared to patients without "pseudo-drusen-like" deposits.


Eligibility Criteria:
Inclusion Criteria:

* Systemic lupus erythematosus
* Case patients : with "pseudo-drusen-like" deposit
* Control patients : without "pseudo-drusen-like" deposit

Exclusion Criteria:

* Patient under a measure of legal protection
DNA Methylation in Brugada Syndrome and Risk of Sudden Cardiac Death

The goal of this observational study is to evaluate if there are differences in DNA methylation of peripheral blood in patients with Brugada syndrome and healthy subjects. The main question it aims to answer is:

Does DNA methylation changes distinguish Brugada patients from healthy controls?

Does DNA methylation changes distinguish Brugada patients with high versus low risk of sudden cardiac death?

The Investigators will enroll 10 patients with Brugada syndrome and 10 age and sex matched healthy controls. We will collect 5 mL of peripheral blood and will analyze genome-wide DNA methylation via EPIC array platform. Bioinformatic algorithms and network analysis will be applied to identify possible diagnostic and predictive biomarkers.

Eligibility Criteria:
Inclusion Criteria:

* Brugada syndrome was confirmed when the 12-lead ECG showed ST-segment elevation with a type-1 morphology of ≥2 mm in ≥1 right precordial lead either spontaneously or after a provocative drug test (intravenous administration of a Class I antiarrhythmic) in the absence of any structural heart disease.
* \>18 years
* Unrelated patients

Exclusion Criteria:

* Related patients
* Not type 1 Br patter
Study of BMS-562086 in the Treatment of Outpatients With Major Depressive Disorder

The purpose of this clinical research study is to learn whether BMS-562086 is both safe and effective in treating outpatients with major depressive disorder.


Eligibility Criteria:
Inclusion Criteria:

* Outpatient women meeting Diagnostic and Statistical Manual of Mental Disorders Manual, Fourth Edition, Text Revision (DSM-IV TR) criteria for a single or recurrent, non-psychotic episode of Major Depressive Disorder (296.2x and 296.3x).
* Patients whose current depressive episode is at least three months in duration at the Baseline Visit.

Exclusion Criteria:

* Males
* Patients with treatment resistance to other antidepressants