cyrilzakka/clinical-trials huggingface dataset:
Effect of ADDE on Tear Interferometry

Importance: Lipid layer thickness (LLT) reflects the lipid components of tear film, but is affected by the mucocutaneous components. This study investigated the therapeutic effect of the treatments for aqueous-deficient dry eye (ADDE) on LLT.

Objective: To investigate the effect of ADDE and its treatments on LLT measurements by tear interferometry.

Design, Setting, and Participants: This prospective comparative interventional study included 152 eyes from 152 patients with ADDE.

Interventions: Participants were classified into four groups: control group (Group 1), 3% diquafosol group (Group 2), punctal plug insertion group (Group 3), and combined treatment group (Group 4).

Main Outcomes and Measures: Average LLT (LLTave) was measured using a LipiView® II tear interferometer at baseline and one month after treatments.


Eligibility Criteria:
Inclusion Criteria:

1. presence of one or more subjective symptoms of DED, including eye dryness, foreign body sensation, irritation, burning, blurred vision, and pain.
2. tear meniscus height (TMH) of \<200 µm for aqueous deficiency measured using Keratograph 5M® (Oculus Optikgeräte GmbH, Wetzlar, Germany).
3. evidence of corneal and/or conjunctival damage on slit-lamp biomicroscopy with fluorescein staining.

Exclusion Criteria:

1. acute and chronic ocular surface diseases that affect DED, including infection, allergy, and autoimmune disease, and that interfere with tear interferometric measurements, such as corneal opacity and pterygium, were excluded.
2. a history of the use of contact lens, known systemic diseases such as Sjögren's syndrome, Stevens-Johnson syndrome, and ocular graft-versus-host disease.
3. any medical/surgical history related to tear production and tear function except that in the study protocol were excluded.
4. Hypersecretory meibomian gland dysfunction (MGD)

   * When both eyes of a patient could be included, an eye with the lower TMH was selected.
Non Syndromic Congenital Heart Defect and Array-CGH in Prenatal Diagnosis

Comparative genomic hybridization (CGH)-based microarrays are now often used during pregnancy in case of fetal polymalformation in order to assess significant genomic alterations. However, it is not clear whether array-CGH provide a diagnostic utility in case of isolated congenital heart defect.

This is the first prospective study aiming at defining the right chromosomal screening when a fetal isolated congenital heart defect is identified by ultrasound.

Comparative genomic hybridization (CGH)-based microarrays are now often used during pregnancy in case of fetal polymalformation in order to assess significant genomic alterations. Up to now, in case of isolated heart defect, only fetal karyotype with FISH 22q11 was usually offered. However, micro deletions or duplications could not be identified elsewhere throughout the genome. Then, in case of fetal chromosomal micro-rearrangements, parents could not be fully informed for global and neurodevelopmental prognosis. To our knowledge, clear-cut study, to assess whether array-CGH provide a diagnostic utility in case of isolated congenital heart defect, don't exist.

After informed consent, 80 women will be enrolled during two years in 2 official prenatal diagnosis centers in France. This survey is assumed to identify at least 8% of unbalanced chromosomal abnormalities. This will be also compared with 22q11 rearrangements rate.

This is the first prospective study aiming at defining the right chromosomal screening when a fetal isolated congenital heart defect is identified by ultrasound.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant woman over 18-year-old ;
* Ongoing health insurance ;
* Informed consent ;
* Prenatal samples from amniotic fluid ;
* Isolated congenital heart defect.

Exclusion Criteria:

* Transposition of great arteries ;
* Amniotic fluid sample refusal.
Characterizing Upper Extremity Function in Individuals With Multiple Sclerosis

Upper extremity (UE) function is critical to maintaining independence. Better understanding of UE involvement in MS will provide necessary information to prioritize the design and selection of future interventions. The goal of the proposed project is to characterize UE involvement in a population of community-based persons with MS across the International Classification of Functioning, Disability \& Health (ICF) domains and constructs.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed clinical Clinical diagnosis of MS
* Receive MS care at the Mandell MS Center
* Cognitively able to understand directions and complete protocol
* Signed consent form approved by the Saint Francis Institutional Review Board
* 18 years of age or older

Exclusion Criteria:

* Unwilling or unable to complete assessments
A PD/Safety Study of RDEA3170 in Combination With Febuxostat for Treating Gout or Asymptomatic Hyperuricemia Patients

The purpose of this study is to explore the pharmacodynamics (PD), pharmacokinetics (PK), safety, and tolerability of multiple doses of RDEA3170 administered in combination with febuxostat compared to RDEA3170 administered alone and febuxostat administered alone in Japanese adult male subjects with gout or asymptomatic hyperuricemia.


Eligibility Criteria:
Inclusion Criteria:

* Screening serum uric acid level ≥ 8 mg/dL;
* Body weight ≥ 50 kg and a body mass index (BMI) ≥ 18 and ≤ 40 kg/m2;
* Free of any clinically significant disease or medical condition, per the Investigator's judgment.

Exclusion Criteria:

* History or suspicion of kidney stones;
* Diagnosis of benign prostatic hypertrophy (BPH) or neurogenic bladder or evidence of BPH/neurogenic bladder such as thin urinary stream or difficulty in urination;
* An estimated creatinine clearance \< 60 mL/min calculated by the Cockcroft-Gault formula;
* QTcF interval (QT interval corrected for heart rate using Fridericia's formula) \> 450 msec at Screening;
* Receiving strong or moderate Cytochrome P450 (CYP) 3A inhibitors or p-glycoprotein inhibitors, or digoxin
Combination With Treg Levels and CMR to Assess the Severity and Prognosis of Reperfusion Injury After PPCI in STEMI Patients

This study aims to determine whether combination with regulatory T cell (Treg) levels and cardiac magnetic resonance imaging (CMR) are predictive of the severity of reperfusion injury following myocardial infarction and the prognosis in STEMI patients receiving primary percutaneous coronary intervention (PPCI).


Eligibility Criteria:
Inclusion Criteria:

* Confirmed STEMI diagnosis
* Undergoing primary percutaneous coronary intervention (presenting \<12 hours after symptom onset)
* Patients were able to complete cardiac magnetic resonance imaging (CMR) and speckle tracking imaging echocardiogram (STE) examinations
* Patients agreed and provided informed consent

Exclusion Criteria:

* Previous myocardial infarction or revascularization (PCI or CABG)
* Congestive heart failure with LVEF\<40%
* Atrial fibrillation
* Renal insufficiency (GFR \< 30 ml/min/1.73m\^2)
* Acute infectious diseases within nearly 3 months
* Rheumatic immune system diseases
* Malignant tumors
* Claustrophobia
* Contraindicated to CMR
* Patients do not agree to be included in the study
PROMUS™ Element™ Everolimus-Eluting Coronary Stent System European Post-Approval Surveillance Study

The goal of the PROMUS™ Element™ Everolimus-Eluting Coronary Stent System European Post- Approval Surveillance Study is to evaluate real world clinical outcomes data for the PROMUS™ Element™ Coronary Stent System in unselected patients in routine clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* According to Instructions For Use

Exclusion Criteria:

* Contraindications according to Instructions for Use
Minimal Invasive Imaging of Coronary Artery Disease in Patients With Asymptomatic Myocardial Injury After Major Non-cardiac Surgery.

This is a cross-sectional pilot study to assess coronary artery disease with minimal invasive techniques in patients with asymptomatic troponin elevation after noncardiac surgery. The primary objective is to quantify coronary artery disease, as determined by coronary CT and MR, as a cause of postoperative myocardial injury. The secondary objective is to correlate coronary calciumscore to postoperative levels of troponin.


Eligibility Criteria:
Inclusion Criteria:

* Major noncardiac surgery with a planned minimal postoperative hospital stay of 2 days
* Age \> 59 years
* Troponin_I elevation \> 0.06 ng/ml in the first 3 post-operative days
* No clinical symptoms of myocardial ischemia

Exclusion Criteria:

* Perioperative troponin elevation due to other factors than coronary artery disease such as proven pulmonary embolism or sepsis
* Perioperative ST-elevation myocardial infarction (STEMI)
* Perioperative symptomatic angina with troponin elevation
* Patients with a history or ECG-signs of myocardial infarction
* Patients with pre-existent heart failure, left ventricular dysfunction, significant valvular disease or left ventricle hypertrophy
* Patients with significant valvular disease or left ventricle hypertrophy determined postoperatively with echocardiography.
* Contra-indication for CMR such as claustrophobia or metal prosthesis
* Allergic reaction to CT-contrast or gadolinium
* Renal dysfunction with GFR \< 50 ml/min, as determined after the operation
* Unstable hemodynamics or other conditions disabling transport to the Radiology department
* Expected major discomfort or substantial increase in pain sensation by undergoing CCTA or CMR
* Admission at the ICU
* Poor prognosis due to other medical conditions e.g. malignancy
Accessing Care, Clinical Trials and Screening for Underserved Children and Adults With Type 1 Diabetes (ACCESS-T1D)

The purpose of this study is to identify people with T1D or celiac disease (CD) early in the course of their disease and to improve the methods of screening for these diseases.

The study will screen people who may be at risk for T1D because they have at least one person in the family with probable T1D. It can be a parent or a sibling. It can also be a second-degree relative, like nieces, nephews, aunts, uncles, grandchildren, or cousins. A relative of someone with T1D is at a higher risk of getting the disease as they are people with other autoimmune diseases. It is possible to detect T1D or CD before it shows any symptoms of high blood sugar. Sometimes, particularly in people who develop T1D in adult life, the disease is misdiagnosed as type 2 diabetes. The treatment and care for the two diseases are different.

Eligibility Criteria:
Inclusion Criteria

1. Able to provide informed consent (adults 18 and above) and assent if seven or above. Legally authorized representative (LAR) is able to provide consent in case of minors or in case of adults unable to consent.
2. Children \> 2 years and adults at elevated risk of developing (or having misdiagnosed) clinically evident Stage 3 T1D because they have at least one of the following:

   i. have one or more first- or second-degree family members (siblings, parents, cousins, aunts/uncles, grandparents) diagnosed with type 1 diabetes or ii. have other autoimmune diseases such as but not limited to celiac disease, Multiple sclerosis, rheumatoid arthritis or, thyroid disease or iii. Those diagnosed with other forms of diabetes which are suspected of being T1D because of a BMI ≤28 or progression to insulin dependence within 3 years from diagnosis.
3. Resides in the following Counties: Orange, Seminole, Osceola, Lake, Volusia, Brevard, Polk, Hillsborough.

Exclusion Criteria

1. People with a diagnosis of type stage 3T1D or T1D clinical definition per ADA Standards of Care
2. History of organ transplant
3. Be deemed unable or unlikely to comply with the protocol.
4. Presence of any condition that, in the opinion of the Investigator, compromises participant safety or data integrity or the participant's ability to complete study visit/s.
Fiber Supplementation in Heart Failure With Preserved Ejection Fraction (HFpEF)

The study team is studying how increasing dietary fiber, specifically through adding potato starch to participant's diet, may impact the species of bacteria in participant's gut microbiome. The study team also wants to understand if adding potato starch to participant's diet helps these bacteria make more short chain fatty acids, a byproduct the team thinks may benefit participant's health.


Eligibility Criteria:
Inclusion Criteria:

* A confirmed clinical diagnosis of stable HFpEF on maximally tolerated Heart Failure (HF) medical regimen (without changes in dosage in the prior month)
* Left ventricular ejection fraction of \>50% documented in the prior 12 months
* A confirmed clinical diagnosis of Type II diabetes (T2DM) with glycated hemoglobin \<10% without changes in medical regimen in the past month.

Exclusion Criteria:

* Current usage of pre- or probiotic usage
* Antibiotic usage in the past 6 months
* Current participation in another interventional clinical trial
* History of potato allergy or potato starch allergy, inflammatory bowel syndrome, inflammatory bowel disease, bowel resection, Roux-en-Y gastric bypass surgery, celiac disease, Crohn's disease, or colorectal cancer
* Hypoglycemic episode with blood glucose 70 milligrams per deciliter (mg/dL) within the last month
* Stage IV-V chronic kidney disease
* Pregnancy (self-reported)
* Comorbidity limiting survival to \< 12 months
cArdiac Non Invasive MApping in resynchronizaTION

Non-invasive mapping using the Cardio Insight system is performed in heart failure patients requiring biventricular pacing to optimize therapy, and understand mechanisms underlying pacing-induced cardiomyopathy and ventricular arrhythmias.

Non-invasive mapping using the Cardio Insight system is prospectively performed routinely in heart failure patients requiring cardiac resynchronization therapy.

Control patients are included, requiring chronic permanent right ventricular pacing.

Specific focus include: optimization of programming parameters, pacing-induced cardiomyopathy, ventricular arrhythmias, defibrillation threshold testing and electrical shocks.

Eligibility Criteria:
Inclusion Criteria:

* Patients implanted with a biventricular pacing device (CRT) device
* Patients chronically implanted with a right ventricular pacing device.

Exclusion Criteria:

* Age \<18 years
Etoposide in Treating Patients With Advanced Ovarian or Cervical Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of etoposide in treating patients who have refractory, recurrent, or metastatic ovarian or cervical cancer.

OBJECTIVES: I. Determine the efficacy of prolonged oral etoposide (VP-16) in patients with advanced ovarian epithelial or cervical cancer. II. Evaluate the frequency and severity of observed adverse effects in this patient population treated with prolonged oral VP-16.

OUTLINE: Patients receive etoposide by mouth once daily on days 1-21 every 4 weeks. Patients with responding disease continue treatment for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients with stable disease continue treatment for up to 6 months in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: If 4-6 responses are observed in the first 25 patients, an additional 15 patients will be entered. The estimated duration of the study is 8 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically confirmed recurrent or metastatic ovarian epithelial or cervical cancer Tissue not accessible for biopsy Refractory to curative therapy or established treatments and ineligible for higher priority GOG protocols Measurable disease required, as follows: Lesion measurable by physical exam Lesion bidimensionally measurable on sonogram or imaging Ascites/pleural effusion not measurable

PATIENT CHARACTERISTICS: Age: Any age Performance status: GOG 0-2 Hematopoietic: WBC at least 3,000/mm3 Absolute granulocyte count at least 1,500/mm3 Platelets at least 100,000/mm3 Hepatic: Bilirubin no more than 1.5 times normal AST no more than 3 times normal Alkaline phosphatase no more than 3 times normal Renal: Creatinine no greater than 2.0 mg/dL Other: Body surface area at least 1 square meter No requirement for intravenous hydration or nutritional support No significant infection No second malignancy other than nonmelanomatous skin cancer

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 3 weeks since anticancer therapy Chemotherapy: No more than 1 prior chemotherapy trial No prior etoposide At least 3 weeks since chemotherapy and recovered Endocrine therapy: At least 3 weeks since anticancer therapy Radiotherapy: At least 3 weeks since radiotherapy Surgery: At least 3 weeks since surgery and recovered
Monitoring of Patients With Inflammatory Bowel Diseases: the Experience of the Reference Center of the Emilia-Romagna

The study is observational with descriptive purposes, aimed at enhancing and deepening current knowledge and providing a foundation for future studies. Specifically, it seeks to identify predictive factors for aggressive disease progression, the development of frailty, the need for surgery and post-surgical outcomes, the development of neoplasia, the assessment of drug safety, and the quality of life in relation to medications or post-surgery.

The total duration of the study is expected to be 10 years. Partial analyses will be conducted during the study for data publication. The clinical data required by the protocol will be collected in a pseudonymized form by personnel designated by the Principal Investigator in an electronic Case Report Form (CRF).

Analysis Methodology:

Descriptive statistical analyses will be used to describe the characteristics of the enrolled patient sample. Continuous variables will be summarized using means, standard deviations, minimum and maximum values, and percentiles. Discrete or nominal variables will be reported as absolute frequencies and relative percentage frequencies.

To study the predictive factors for disease progression, development of frailty, need for surgery, etc. (primary objectives), multivariate models (logistic regression analysis) will be used, and Odds Ratios with 95% confidence intervals (OR - CI 95%) will be calculated.

The calculation of frequencies and the estimation of event incidences, such as drug resistance, development of comorbidities, extraintestinal manifestations, and other observed episodes/events (secondary objectives) will be accompanied by their respective 95% confidence intervals (CI 95%). Analyses may focus on subcohorts of patients with different demographic and clinical-diagnostic characteristics to evaluate their varying risk probabilities.

Data will be processed using IBM SPSS statistical software (version 25.0).

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Age \> 14 years
* Diagnosis of inflammatory bowel disease (Crohn's Disease, Ulcerative Colitis, Indeterminate Colitis, Microscopic Colitis) according to ECCO guidelines
* Having undergone at least one outpatient visit and/or hospitalization at the Regional Reference Center for IBD "Massimo Campieri"
* Acquisition of written informed consent from the patient and/or both parents/legal guardian

Exclusion Criteria:

- None
A Retrospective Study on the Factors of Drug-coated Balloon Restenosis

The purpose of this study is to analyze potential factors post paclitaxel drug-coated balloon angioplasty in patients with Denovo large vessels disease. It includes imaging endpoints and clinical event endpoints. Over 5000 patients are expected to be enrolled.

This study is a retrospective analysis that retrospectively reviewed over approximately 5000 patients with de novo-large-vessel disease who underwent paclitaxel drug-coated balloon angioplasty. The study endpoints include cardiovascular adverse events at 1 year (cardiovascular death, cardiovascular events) and coronary angiographic outcomes (primarily late lumen loss, restenosis rate). It primarily focuses on differences in baseline characteristics, lesion features, intracavitary imaging characteristics(Including OCT, IVUS), hemodynamic parameter，and procedural approaches among patients. Over 5000 patients are expected to be enrolled.

Eligibility Criteria:
Inclusion Criteria:

* Age:

  18 years and older.
* Diagnosis:

Diagnosed with coronary artery disease with native large vessel lesions confirmed by coronary angiography.

* Treatment Plan:

Scheduled to receive paclitaxel drug-coated balloon angioplasty.

* Informed Consent:

Patients have been fully informed about the nature and purpose of the study, and have voluntarily agreed to participate, with signed informed consent.

* Physiological Status:

Cardiac function classified as NYHA I-III.

Exclusion Criteria:

* Allergy History:

Known allergies to paclitaxel or any materials used in angioplasty (e.g., contrast agents).

* Severe Complications:

Uncontrolled hypertension (systolic blood pressure \>180 mmHg or diastolic blood pressure \>110 mmHg).

* Other Medical Conditions:

Active bleeding or clotting disorders.

* Other serious diseases with a life expectancy of less than 1 year (e.g., advanced cancer).
* Pregnancy or Nursing: Women who are currently pregnant or breastfeeding.
* Participation in Other Studies: Currently participating in other clinical trials that might affect the results of this study.
* Psychological or Behavioral Factors: History of psychiatric or behavioral disorders that could interfere with adherence to study protocols, or communication barriers that prevent understanding of study requirements.
Double-blind, Randomized Study Evaluating the Efficacy and Safety of Brivaracetam in Adults With Partial Onset Seizures

This study will evaluate the efficacy and safety of Brivaracetam to support the submission file in the indication of adjunctive treatment in adolescents and adults with partial onset seizures.


Eligibility Criteria:
Inclusion Criteria:

* Subjects were from 16 to 70 years, both inclusive. Subjects under 18 years of age were only included where legally permitted and ethically accepted
* Subjects with well-characterized focal epilepsy or epileptic syndrome according to the International League Against Epilepsy (ILAE) classification
* Subjects had a history of partial onset seizures (POS) whether or not secondarily generalized (Type I seizures according to the ILAE classification)
* Subjects had at least 2 POS whether or not secondarily generalized per month during the 3 months preceding Visit 1
* Subjects had at least 8 POS whether or not secondarily generalized during the 8-Week Baseline Period
* Subjects were uncontrolled while treated by 1 to 2 permitted concomitant antiepileptic drugs (AEDs). Vagal nerve stimulation was allowed and was not counted as a concomitant AED

Exclusion Criteria:

* History or presence of seizures occurring only in clusters (too frequently or indistinctly separated to be reliably counted) before Visit 3
* History or presence of status epilepticus during the year preceding Visit 1 or during Baseline