cyrilzakka/clinical-trials huggingface dataset:
Potential Impact of Cigarette Smoking on Platelet Reactivity in Patients on Dual Antiplatelet Therapy With P2Y12 Inhibitors

All consecutive patients undergone PTCA in the period between July 2013 and December 2013 are eligible to be enrolled. Study population are divided in :

Group 1: smokers on dual antiplatelet therapy with ASA (100 mg once a day) and Prasugrel (10 mg die); Group 2: smokers on dual antiplatelet therapy with ASA(100 mg once a day) and Ticagrelor (90 mg twice a day); Control group: smokers on dual antiplatelet therapy with ASA(100 mg once a day) and Clopidogrel (75 mg once a day).

Platelet function is evaluated using a validated method: the VerifyNow System (Accumetrics Inc., San Diego, CA), which is a point-of-care turbidimetry-based optical detection system that measures platelet-induced aggregation. These value are measured Platelet function, measured with the VerifyNow P2Y12. All patients on chronic dual antiplatelet therapy (\>1 month) quit smoking for a 2 weeks period. Therefore PRU values are obtained at baseline (at the enrollment time) and after 2 weeks after smoking cessation. Platelet reactivity are expressed in P2Y12 reaction units (PRU). PRU values \>240 are suggestive of high platelet reactivity.

Primary outcomes: P2Y12 reaction units (PRU) at baseline and two weeks after quitting smoking.

All consecutive patients undergone PTCA in the period between July 2013 and December 2013 are eligible to be enrolled. Study population are divided in :

Group 1: smokers on dual antiplatelet therapy with ASA (100 mg once a day) and Prasugrel (10 mg die); Group 2: smokers on dual antiplatelet therapy with ASA(100 mg once a day) and Ticagrelor (90 mg twice a day); Control group: smokers on dual antiplatelet therapy with ASA(100 mg once a day) and Clopidogrel (75 mg once a day).

Platelet function is evaluated using a validated method: the VerifyNow System (Accumetrics Inc., San Diego, CA), which is a point-of-care turbidimetry-based optical detection system that measures platelet-induced aggregation. These value are measured Platelet function, measured with the VerifyNow P2Y12. All patients on chronic dual antiplatelet therapy (\>1 month) quit smoking for a 2 weeks period. Therefore PRU values are obtained at baseline (at the enrollment time) and after 2 weeks after smoking cessation. Platelet reactivity are expressed in P2Y12 reaction units (PRU). PRU values \>240 are suggestive of high platelet reactivity.

Primary outcomes: P2Y12 reaction units (PRU) at baseline and two weeks after quitting smoking.

Eligibility Criteria:
Inclusion Criteria:

* All consecutive patients undergone PTCA in our institution in the period between July 2013 and December 2013 will be eligible to be enrolled.
* smokers will be all patients smoking 15±10 cigarettes daily.
* patients on dual antiplatelet therapy with ASA and P2Y12 inhibitors.
* recent (\<12 months) percutaneous coronary interventions
* angiographically-proven coronary artery disease

Exclusion Criteria:

- people unable to understand and willing to sign the informed consent form
Opioid Use Disorder in Pregnancy in Long-Term Maternal/Infant Outcomes

The objective of this study is to better understand the comprehensive integration of both clinical and genetic factors that will help to identify mothers who could be at an increased risk of poor response to opioid substitution and infants at risk of significant neonatal abstinence syndrome (NAS).

One of the greatest impacts on maternal/infant health in the United States today is mother's who have opioid use disorder also known as OUD. This study will look at how in-utero buprenorphine also known as subutex, effects both mother/fetus in prenatal stages with MRI's, blood draws, and a series of assessments. After the neonate is born, there will be follow-up with that baby for up to 2 years with another neonatal MRI, blood draws and infant/child assessments. Planning to enroll 200 mothers who have opioid use disorder and 100 mothers with no previous opioid use.

Eligibility Criteria:
Inclusion Criteria:

* Age greater 18 years
* Currently taking Buprenorphine for Opioid Use Disorder and enrolled in a prenatal opioid maintenance program in the antenatal clinic at IU Health University Hospital.
* Pregnant with single baby
* Planned delivery at Methodist, University or Riley Hospital

Exclusion Criteria:

* Serious maternal medical illness as deemed by study physician or investigator.
* Known or suspected major fetal/neonatal congenital abnormalities.
Evaluation of the Ear-EEG System for Sleep Monitoring in Healthy Subjects

Subjects sleep multiple nights in their own home, wearing actigraph, PSG (PolySomnoGraphy) and ear-EEG sensors. The object of the study is to determine the applicability of ear-EEG for sleep monitoring.


Eligibility Criteria:
Inclusion Criteria:

Informed consent obtained and letter of authority signed before any study related activities

Age 18-50 years

-

Exclusion Criteria:

1. BMI (body mass index) \> 30
2. Previous stroke or cerebral haemorrhage and any other structural cerebral disease
3. Known or suspected abuse of alcohol or any other neuro-active substance
4. Use of hearing aid or cochlear implants
5. Allergic contact dermatitis caused by metals or generally prone to skin irritation
6. Narrow or malformed ear canals
7. Obstructive sleep apnea
8. History of sleep disorders or neurological diseases
9. Chronic pain
10. People judged incapable, by the investigator, of understanding the participant instruction or who are not capable of carrying through the investigation.
11. Use of medication known to influence the user's sleep (antidepressants, sedatives, antipsychotic-, and pain relieving medication)
12. Teeth grinding (bruxism)
13. Pregnancy
Effect of the Level of Dietary Protein on Body Composition

The purpose of this study is to determine if toddlers and children who were fed breast milk or infant formulas at different levels of protein between 3 and 12 months of age have differences in growth and body composition at 3 and 5 years of age.


Eligibility Criteria:
Inclusion Criteria:

* Previous participation in infant formula controlled protein study
* Body composition data from 6 month of age available
* Consent obtained from legal representative
* Within age parameters specified in protocol around the 3 and 5 year age points

Exclusion Criteria:

* Unable to endure testing procedures upon evaluation of the Investigator
* Outside the age range of the study
Effect of Changing the Activation Frequency of the Arch Wires on the Rate of Leveling and Alignment in Moderate Crowding Cases

Leveling and alignment is the first stage in the orthodontic treatment, performed for every patient .The archwire are usually changed every 4 weeks for reactivation of the force on the teeth. However, this means that large number of appointments and archwires are required. On the other hand, there is a lack of evidence that less number of appointments with longer time intervals between the visits and less number of wires will give the same effect.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients aged (18\~33)
* CVMI = 6
* Moderate crowding (4-8) as described by Laura mitchel
* No extractions required

Exclusion Criteria:

* Growing patients
* Previous orthodontic treatment
* Missing teeth other than the wisdoms
Safety, Tolerability and Efficacy of ISIS-GCCRRx in Type 2 Diabetes

The purpose of this study is to evaluate the efficacy, safety and tolerability of ISIS-GCCRRx in combination with metformin versus placebo + metformin


Eligibility Criteria:
Inclusion Criteria:

* Male or female, age 18 to 75
* BMI greater than or equal to 25
* HbA1c greater than or equal to 7.5% and less than or equal to 10.5%
* Type 2 Diabetes Mellitus and on stable dose of oral metformin
* Agree to conduct home-based (fasted) blood glucose testing as directed

Exclusion Criteria:

* Clinically significant abnormalities in medical history or physical exam
* Show evidence of uncorrected hypothyroidism or hyperthyroidism hormone results
* History of renal transplantation or renal dialysis
* History of liver disease
* History of greater than 3 episodes of severe hypoglycemia within 6 months of screening
* Use of oral anti-diabetic medication other than metformin within 3 months of screening
* Use of medications that may affect plasma glucose levels (including systemic glucocorticoids), systemic steroids, corticosteroids, antiglucocorticoid therapies including mifepristone and ketoconazole (topical cream and systemic), immunosuppressive medications, somatostatin analogues or ACTH therapy within 3 months of screening
* History of diabetic ketoacidosis
* Current or previous diagnosis of Gilbert's disease
* Any other significant illness or condition that may interfere with the patient participating or completing the study
* Inability or unwillingness to comply with protocol or study procedures
A Phase 1, Dose Escalation Trial of RP-A601 in Subjects With PKP2 Variant-Mediated Arrhythmogenic Cardiomyopathy (PKP2-ACM)

This Phase 1 dose escalation trial will assess the safety and preliminary efficacy of a single dose intravenous infusion of RP-A601 in high-risk adult patients with PKP2-ACM.


Eligibility Criteria:
Key Inclusion Criteria:

1. Male or female ≥18 years at the time of signing the informed consent
2. Capable and willing to provide signed informed consent
3. Clinical diagnosis of ACM as defined by the 2010 revised Task Force Criteria (TFC)
4. Documentation of a pathogenic or likely pathogenic truncating variant in PKP2
5. History of Implantable Cardioverter-Defibrillator (ICD) implantation ≥6 months prior to enrollment
6. PVC frequency ≥500 per 24 hours by ambulatory rhythm monitoring
7. Left ventricular ejection fraction by echocardiogram or CMR ≥50%

Key Exclusion Criteria:

1. Anti-AAVrh.74 capsid neutralizing antibody titer of \>1:40
2. Cardiomyopathy related to a genetic etiology other than PKP2 truncating variant
3. Previous participation in a study of gene transfer or gene editing
4. Severe Right ventricular (RV) dysfunction
5. New York Heart Association (NYHA) Class IV heart failure.
Comparison of BIOdegradable Polymer and DuRablE Polymer Drug-eluting Stents in an All COmeRs PopulaTion (BIO-RESORT)

The introduction of drug-eluting stents (DES) in the treatment of coronary artery disease has led to a significant reduction in morbidity. However, the first generation of these devices had no positive impact on the mortality after PCI (compared to bare metal stents), which was greatly attributed to a somewhat increased incidence of late and very late stent thrombosis. Concerns about the role of durable polymers as a potential trigger of inflammation and finally adverse events also led to the development of DES with biodegradable coatings, which leave after degradation of the coating only a bare metal stent in the vessel wall that does not induce an inflammatory response. While such biodegradable polymer DES are increasingly used in clinical practice, there is no data available from head-to-head comparisons between biodegradable and contemporary third generation durable polymer DES.


Eligibility Criteria:
Inclusion Criteria:

* Minimum age of 18 years.
* Significant coronary artery disease and lesion(s) eligible for treatment with drug eluting stents according to clinical guidelines and/or the operators' judgement.
* Capable of providing informed consent.
* Patients with all clinical syndromes will be enrolled without any exclusion based on number, type, location, or length of lesions to be treated.

Exclusion Criteria:

* Known intolerance to components of one of the stents that will be investigated or known intolerance to antithrombotic and/or anticoagulant therapy that prevents adherence to dual antiplatelet therapy.
* Planned elective surgical procedure necessitating interruption of dual antiplatelet therapy during the first 6 months after randomization.
* Participation in another randomized drug or device trial before reaching primary endpoint.
* Adherence to scheduled follow-up is unlikely or life expectancy assumed to be less than 1 year.
* Known pregnancy
Current Value of Axillary Ultrasound in the Staging of Breast Cancer. Is BSGC Still Necessary?

AUS/FNAC allows the identification of tumors without axillary tumor involvement, or with low axillary tumor burden, many of which do not benefit from SLNB, in the staging of early breast cancer.

Objective: To calculate the negative predictive value of AUS/FNAC in those patients with breast cancer who meet ACOSOG Z0011 criteria.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Tumors with ACOSOG Z0011 criteria, except positive SLNB (cT1-T2; cN0; breast-conserving surgery; Whole-Breast Radiotherapy)
* Axillary study with AUS/FNAC.
* SLNB/ALND (Gold-Standard).

Exclusion Criteria:

* Tumors without confirmation of axillary histologic status (No Gold-Standard)
* Tumor in pregnancy or breastfeeding.
* Tumors in the male.
* Tumors treated with neoadjuvant chemotherapy
* Tumors that do not meet ACOSOG Z0011 criteria.
* Tumors without axillary study using AUS/FNAC
Clinical Feasibility of Speech Phenotyping for Remote Assessment of Neurodegenerative and Psychiatric Disorders

The primary objective of the study is to evaluate the feasibility of eliciting continuous narrative speech in different neurodegenerative and psychiatric indications, using remote, self-administered speech tasks, as measured by the average length of speech elicitation for each speech task during the first week of self-assessment. Secondary objectives include (1) evaluating the reliability of speech tasks in the remote self-administered setting, as measured by the intra- and inter-subject variance; (2) accessing the adherence of speech tasks in this setting, as measured by the subject average fraction of days during the first week, where at least one task response is submitted; (3) evaluating the feasibility of using speech tasks in the setting of a telemedicine videoconference, as measured by the average length of speech elicited in each group; (4) evaluate whether a set of acoustic and linguistic patterns can detect each indication, compare to either a control group or all other indications, as measured by the area under the receiver operating characteristic curve (AUC), sensitivity, specificity and Cohen's kappa of the relevant binary classifier; (5) evaluating how the performance of such algorithms can be impacted by speaker and environment covariates, as measured by the Kendall rank correlation coefficient of the AUC of each classifier and each of age group, gender and speech-to-reverberation modulation energy ratio.


Eligibility Criteria:
Inclusion Criteria:

* Willing to participate, having been provided full information about the study components and details.
* Native language is English.
* Has the capacity to provide fully informed consent.
* Has access to and able to use, or has a caregiver who has access to and able to use a smartphone device running an operation system of iOS 11.0 or later, or Android 7.0 or later.
* Able to use, or has a caregiver who is able to use a personal computer, notebook or tablet.
* Has access to a personal computer, notebook or tablet that is (1) Running an operating system of:

macOS X with macOS 10.9 or later; OR Windows 7 or above; AND (2) Capable of audio recording; AND (3) Able to connect to the internet; AND (4) Have access to one of following internet browser software: Internet Explorer version 11 or above; OR Microsoft Edge version 12 or above; OR Firefox version 27 or above; OR Google Chrome version 30 or above; OR Safari version 7 or above.

Exclusion Criteria:

* Diagnosis of alcohol or drug use disorder;
* History or presence of stroke within the past 2 years;
* Documented history of transient ischemic attack or unexplained loss of consciousness within the last 12 months.
* At risk of suicide: score of 10 or above on the PHQ scale, and 10 or above on the MINI suicide questionnaire
Biofeedback for Fecal Incontinence

Fecal incontinence affects 2% of adults in the United States. Biofeedback has been recommended for the treatment of fecal incontinence because uncontrolled studies over the past 25 years suggest that these treatments are as effective as medical or surgical management and involve no risk. However, placebo-controlled trials are still lacking.

The aims of this study are: (1) to compare biofeedback to alternative therapies for which patients have a similar expectation of benefit; (2) to identify which patients are most likely to benefit; and (3) to assess the impact of treatment on quality of life.

Study I is a long-term, prospective, single-blind study comparing biofeedback for fecal incontinence to a standard therapy (Kegel exercises) that is associated with a similar expectation of improvement (i.e., comparable placebo effect). Prior to randomization, patients will receive medical therapy (antidiarrheal medications as appropriate) and education for 4 weeks, and only patients who remain incontinent will be randomized. Anal canal squeeze pressures and rectal sensory thresholds will be tested before and after treatment. Patients will keep a diary throughout baseline and treatment, and they will be re-assessed at 3, 6, and 12 months. Treatment will consist of 6 clinic visits at 2-week intervals. The primary outcome is the patient's response to the question, "Have you had satisfactory relief of fecal incontinence (yes/no)?" This question is asked at 3 months following the end of treatment and at each follow-up visit. The investigators will develop a detailed treatment manual for fecal incontinence which would permit other investigators to replicate our study.

Eligibility Criteria:
Inclusion Criteria:

* Males or females age 16 or above who have an average of one or more episodes of fecal incontinence per week

Exclusion Criteria:

* Previous biofeedback treatment
Galectin and Respiratory Weaning

Galectin-3 is a biomarker for fibrotic activity. In the course of invasive ventilation, fibrotic changes in the lungs may occur. The study aims to investigate whether the level of galectin-3 levels correlates with clinical weaning parameters.

Galectin-3 (Gal-3) is a protein with an important role in cell-cell adhesion, cell-matrix interactions, macrophage activation, angiogenesis, metastasis and apoptosis. Galectin-3 is expressed in the nucleus, cytoplasm, mitochondrion, cell surface, and extracellular space.It is involved in different biological processes: cell adhesion, cell activation and chemoattraction, cell growth and differentiation, cell cycle, and apoptosis. Several studies revealed the function of galectin-3 in cancer, inflammation and (lung) fibrosis, heart disease, and stroke. Expression of galectin-3 is associated with heart failure, including myofibroblast proliferation, fibrogenesis, tissue repair, inflammation, and ventricular remodeling. A correlation between galectin-3 expression levels and various types of fibrosis has been found. Galectin-3 is upregulated in idiopathic pulmonary fibrosis.

Mechanical ventilation can cause lung damage, or worsen it if already present. This phenomenon is called ventilation-induced lung damage. Main mechanisms are high tidal volumes causing overexpansion of the lungs (volutrauma), high airway pressure (barotrauma) and cyclical collapse and reopening of atelectatic alveolar regions (atelectrauma) leading to a pulmonary inflammatory reaction called "bio-trauma".

To evaluate the (potential) lung injury serum levels of galectin-3 are measured on admission to our hospital. During respiratory weaning invasiveness of ventilation will be reduced. Data relating biomarkers especially galectin3 during/after successful respiratory weaning are missing.

This is why follow up measurements of galectin-3 will be done and correlated with ventilation parameters/duration/ success of respiratory weaning.

Prior studies evaluated the role of proGRP and CA 15-3 in patients with lung fibrosis. As a part of the study galectin-3 serum levels will be correlated with serum levels of proGRP and CA 15-3.

In summary the aim of this study is to evaluate the diagnostic value of galectin-3 in respiratory weaning.

Eligibility Criteria:
Inclusion Criteria:

* written informed consent
* mechanical ventilation

Exclusion Criteria:

* history of pulmonary disease
* left ventricular ejection fraction\<45%
* missing declaration of consent
Comparison of Outcomes of Rotator Cuff Repair With a Modified Versus Classic Double-Row Suture -Bridge Techniques

rotator cuff tears are one of the most common shoulder issues , affecting 20.7% of the general population .

accompanied by shoulder pain and dysfunction

Eligibility Criteria:
Inclusion Criteria:

* full-thickness supraspinatus
* degenerative tears
* age range 40 :65

Exclusion Criteria:

* subscapularis tear
* small and massive tears
* traumatic tears
* partial -thickness tear
* revisioin surgery
* glenohumeral arthretic changes and shoulder instability
Comparison of Two Exercise Programmes in Patients Undergoing Hemodialysis

Although exercise training of haemodialysis patients is associated with generally positive outcomes few haemodialysis units routinely offer intradialytic exercise therapy. This is often related to financial cost and/or staffing limitations. Home-based programs could be an alternative means of providing exercise benefits without associated implementation costs The aim of this study was to compare the effects of 4 weeks intradialytic versus home based exercise for haemodialysis patients regarding adherence and strength gains.


Eligibility Criteria:
Inclusion Criteria:

* people under hemodialysis treatment at least 3 months
* be medicable stable
* complete all the physical tests

Exclusion Criteria:

* heart stroke in the previous 6 weeks of the study
* inferior limb amputation without artificial aids
* cerebral vascular disease (ictus, ischemic)
* disability to complete functional tests
A Double-blinded, Randomised, Two -Period Crossover Euglycemic Clamp Trial Investigating the Pharmacokinetics, Glucodynamics and Safety of BioChaperone Insulin Lispro and Insulin Lispro (Humalog®) in Subjects With Type 1 Diabetes

The addition of Biochaperone to insulin lispro may accelerate the onset and shorten the duration of action of insulin lispro due to a facilitation of the absorption of the insulin after subcutaneous injection.

The aim of the trial is to assess the efficacy and safety of BioChaperone insulin lispro in subjects with Type 1 diabetes under a dose of 0.2 U/Kg.

This trial is a single-center, randomised, double-blinded, two-treatment, two-period cross-over, 6-hour euglycaemic glucose clamp trial in subjects with Type 1 diabetes mellitus. Each subject will be randomly allocated to a single dose of BioChaperone insulin lispro 0.2 U/Kg and a single dose of Humalog® 0.2 U/Kg on 2 separate dosing visits.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes mellitus for at least 12 months.
* Treated with multiple daily insulin injections or insulin pump for at least 12 months.
* Body Mass Index (BMI): 18.0-28.0 Kg/m².

Exclusion Criteria:

* Type 2 diabetes mellitus.
* Receipt of any investigational product within 3 months prior to first dosing.
* Clinically significant abnormalities as judged by the investigator.
* Any systemic treatment with drugs known to interfere with glucose metabolism.
* History of alcoholism, or drug/chemical abuse as per Investigator's judgement.
* Use of tobacco or nicotine-contained product within 5 years prior to screening.
* Blood or plasma donation in the past month or more than 500 mL within 3 months prior to screening.