cyrilzakka/clinical-trials huggingface dataset:
Dexamethasone-Implant for the Treatment of Macula Edema Due to Irvine Gass Syndrome

To analyze macula edema formation after cataract surgery called Irvine-Gass-Syndrome.

20 to 25 patients suffering from Irvine Gass Syndrom should be monitored for at least six months, controlled monthly. In all cases best corrected visual acuity, Spectralis-OCT (volume thickness scan), fundus photography (Optomap), intraocular pressure, slitlamp assessment and indirect ophthalmoscopy should be performed on every visit. Fluorescein angiography should be performed at baseline and after 3 and 6 months.

Inclusion criteria:

Patients older than 18 years who develop macula edema secondary to cataract surgery.

- Consent agreement - Patients should be informed that it is possible to get an active medication (Ozurdex implant) as an "on label" indication from the health insurance company if the diagnosis is accepted as an intraocular inflammation form of "Uveitis posterior".

Exclusion criteria:

Visual acuity worse than 20/400, known history of glaucoma and steroid response, any macular disease interfering with visual acuity (DME, AMD, etc.), history of vitrectomy, use of systemic, periocular, or intraocular corticosteroids within 30 days.

Outcome:

* BCVA
* Patients suffering from diabetes mellitus should be evaluated also separately.
* Change in central retinal thickness using optical coherence tomography (OCT)
* Secondary parameters (elevated IOP, retinal detachments, vitreous hemorrhage, endophthalmitis rates)

Eligibility Criteria:
Inclusion Criteria:

Patients older than 18 years who develop macula edema secondary to cataract surgery

Exclusion Criteria:

Visual acuity worse than 20/400, known history of glaucoma and steroid response, any macular disease interfering with visual acuity (DME, AMD, etc.), history of vitrectomy, use of systemic, periocular, or intraocular corticosteroids within 30 days.
End-expiratory Trans-pulmonary Pressure Guided PEEP Titration in Patients With Pulmonary Fibrosis and UIP Pattern Undergoing Mechanical Ventilation

Patients with pulmonary fibrosis and associated usual interstitial pneumonia that require mechanical ventilation for acute respiratory failure experience poor clinical outcomes. This may be influenced by the unfavorable interaction between the fibrotic lung and the stress and strain stimuli generated during controlled ventilation. Although there is no consensus on how to ventilate these patients, much of the recommendations followed in clinical practice are taken from the experience on patients with acute respiratory distress syndrome. Among these, measuring the esophageal pressures and adjusting positive-end expiatory pressure to make trans-pulmonary pressures positive can decrease atelectasis, derecruitment of lung, and cyclical opening and closing of airways and alveoli, thus optimizing lung mechanics and oxygenation. The effect of this strategy on the fibrotic lung has not yet been documented. With this observational study we aim at documenting the effect of PEEP titration maneuver based on end-expiratory trans-pulmonary pressure on lung mechanics of patients with pulmonary fibrosis and UIP pattern,


Eligibility Criteria:
Inclusion Criteria:

* pulmonary fibrosis with UIP pattern
* subjected to endotracheal intubation and controlled mechanical ventilation for acute respiratory failure
* candidate to a trial of PEEP titration according to positive end expiratory pressure.

Exclusion Criteria:

* chest wall deformities
* chronic obstructive pulmonary disease
Inhaled Iloprost (Ventavis): Efficacy, Safety, and Pharmacokinetics (PK) Confirmation Study

This study is to investigate the efficacy, safety, and Pharmacokinetics (PK) of Inhaled Iloprost (Ventavis) therapy in Japanese pulmonary arterial hypertension (PAH) patients in Main Treatment Phase (12 weeks) and to investigate the safety, tolerability, and efficacy of longterm Inhaled Iloprost (Ventavis) therapy in Japanese PAH patients in Extension Phase.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects aged 18 to 75 years
* Symptomatic Pulmonary Artery Hypertension (PAH) classified (Dana Point Classification 1)
* New York Heart Association (NYHA)/World Health Organization (WHO) functional class III or IV
* PAPmean at rest \> 25 mm Hg, Pulmonary capillary wedge pressure (PCWP) or left ventricular end-diastolic pressure \</= 15 mm Hg and Pulmonary Vascular resistance (PVR) \>/= 240 dyn.sec.cm-5 (\>/= 400 dyn.sec.cm-5 for patients treated with both endothelin receptor antagonist (ERA) and phosphodiesterase-5 inhibitor (PDE5i) ) as measured by Right Heart Catheter test
* Women of childbearing potential and men must agree to use adequate contraception when sexually active

Exclusion Criteria:

* Baseline 6-minute walk distance of less than 100 meters or more than 500 meters
* Subjects with critical severe PAH
* Forced Expiratory Volume in 1 second (FEV1)/Forced Vital Capacity (FVC) ratio \< 60% and/or Total Lung Capacity (TLC) \< 70% predicted (especially at interstitial lung disease, TLC \< 60% predicted)
* Clinically relevant obstructive lung disease (e.g. asthma or chronic obstructive pulmonary disease )
* More than mild patchy interstitial lung disease on High Resolution Computerized Tomography (HRCT)
* History of left-sided heart disease
* Uncontrolled systemic hypertension as evidenced by systolic blood pressure \>/= 160 mm Hg or diastolic blood pressure \>/= 100 mm Hg on repeated measurement
* Systemic hypotension with systolic blood pressure \< 85 mm Hg
A Study of Efficacy and Safety of Topiramate in the Treatment of Obese Patients With Mild to Moderate Essential Hypertension

The purpose of this study is to compare the efficacy and safety of daily topiramate (96mg or 192mg) versus placebo in obese patients with mild to moderate high blood pressure.

Topiramate is not approved for the treatment of obesity. The use of topiramate to reduce weight in obese patients may have the adjunctive benefit of reducing blood pressure in subjects with treated or untreated hypertension, on or off background antihypertensive medications. This double-blind, placebo controlled study investigates the long-term efficacy of topiramate for reduction of weight and blood pressure in obese patients with mild-moderate hypertension, and the safety and tolerability of topiramate in this patient population. The study consists of 4 phases: 6 week run-in phase (2 weeks screening and 4 weeks single-blind placebo), 8 week titration phase (topiramate group will have their dose increased from 16mg/day to either 96mg/day or 192mg/day), 52 week maintenance phase (patients will receive fixed dose of either topiramate or placebo) and 6 week follow-up phase. Beginning at enrollment and throughout the study, all subjects participated in a standardized behavioral modification program which provides subjects with lifestyle and self-management strategies for diet, nutrition and physical activity. Effectiveness will be evaluated by multiple measurements such as change in body weight, sitting diastolic blood pressure, sitting systolic blood pressure, Body Mass Index, number and proportion of treatment responders, volume of left ventricle of the heart as measured by echocardiography, and fasting lipid profile. Safety evaluations (incidence and severity of adverse events, vital signs, 12 lead ECG, clinical laboratory results) will be conducted throughout the study. The study hypothesis is that topiramate is effective in reducing blood pressure in obese patients with mild to moderate hypertension and is well tolerated. During the initial 8 weeks, the dose of topiramate or placebo will be gradually increased to the target doses (either 48mg twice daily or 96mg twice daily by mouth) and the doses will be maintained for 52 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of mild to moderate essential hypertension (sitting diastolic blood pressure \>= 90 and \< 110 and/or sitting systolic blood pressure \>= 140 and \< 180)
* Diagnosis of obesity (Body Mass Index \>= 27 and \< 50 and steady body weight)
* Female patients must be postmenopausal for at least 1 year, surgically incapable of childbearing, practicing abstinence, or practicing an acceptable method of contraception (requires negative pregnancy test)

Exclusion Criteria:

* Prior exposure or known contraindication or hypersensitivity to topiramate
* Pregnancy, nursing or subjects who plan to become pregnant during the study
* Diagnosis of severe hypertension
* History or diagnosis of Diabetes Mellitus
* A history of diastolic or systolic hypertension secondary to a known cause
* Significant cardiovascular or liver disease
Hypoglycemia and Glucagon Response in CF

The goal of this clinical trial is to investigate the etiopathogenesis of isolated hypoglycemia and hypoglycemia with abnormal glucose tolerance in children with Cystic Fibrosis (CF) and to evaluate the role of glucagon and pancreatic insufficiency on hypoglycemia in CF. The main questions it aims to answer are:

1. Do isolated hypoglycemia and hypoglycemia with abnormal glucose tolerance have different etiopathogenesis?
2. What is the role of pancreatic insufficiency in these two conditions? Participants were asked to perform 3-h OGTT and to take blood samples. Researchers compared with healthy peers to see if there is isolated hypoglycemia in OGTT and how is the glucagon response to OGTT in healthy peers.

The exact underlying mechanism of hypoglycemia in CF is still unknown. Some recent studies support the delayed and prolonged insulin secretion and impaired counterregulatory hormone response as the reason of reactive hypoglycemia, whereas the others argued an additive effect of an intrinsic factor.

However, the weakness of these limited studies is that nearly all of them included CF patients who had pancreatic insufficiency (PI) and could not reveal the mechanism of hypoglycemia seen in those without PI. In addition, there were no healthy controls for comparison of glucagon secretion in CF patients with hypoglycemia. Moreover, the studies that evaluate the role of glucagon in hypoglycemic CF patients were performed in hypoglycemic adult patients with abnormal glucose tolerance (AGT) and the delayed and prolonged insulin release is expected to be more likely as the reason of hypoglycemia in this setting. Previously, the investigators had demonstrated isolated hypoglycemia in some of the pediatric CF patients during OGTT. In this study, the investigators aimed to further investigate possible mechanisms of hypoglycemia. The investigators hypothesized that the mechanism of isolated hypoglycemia might be different from hypoglycemia seen in patients with AGT. Furthermore, the investigators evaluated the role of pancreatic insufficiency in hypoglycemia of CF patients by analyzing glucose, insulin and glucagon response to a glucose load in CF patients with and without PI.

Eligibility Criteria:
Inclusion Criteria:

* 10-18 year-old children genetically diagnosed with Cystic Fibrosis
* Regularly followed by the department of pediatric endocrinology

Exclusion Criteria:

* Using corticosteroid therapy in the last 3 months
* Those who had acute exacerbation in the last 3 months
* Previously diagnosed with diabetes
Target Volume Delineation After NACT in LA-NPCarcinoma Patients Treated With NACT+ CCRT

The gross tumor volumes of the primary site and the neck nodes (GTVnx and GTVnd) could be delineated according to the post-NACT tumor position and receive radical radiation dose, while the tumor disappear after NACT could be encompassed in the first clinical target volume (CTV1) and receive high preventive radiation dose. Through this method,it is more likely to achieve the ultimate goal that maximize the chance of cure while minimize the injury of surrounding normal tissues, maintaining organ function and life quality. Therefore, this stage II clinical trial was designed to study the prognosis and locoregional failure patterns of this target volume delineation method in LA-NPC treated with NACT plus CCRT.


Eligibility Criteria:
Inclusion Criteria:

1. histologically confirmed NPC;
2. no evidence of distant metastasis;
3. no previous treatment for NPC;
4. stages III-IVb disease according to the staging system of the 6th AJCC/UICC;
5. adequate liver, renal and bone marrow function;
6. Karnofsky Performance Status (KPS) ≥80 scores.

Exclusion Criteria:

1. fine-needle aspiration biopsy, incisional or excisional biopsy of neck lymph node, or neck dissection prior NACT;
2. disease progression during NACT;
3. presence of distant metastasis;
4. pregnancy or lactation;
5. previous malignancy or other concomitant malignant disease.
Galvanize Prospective/Retrospective Pulsed Electric Field Device Registry

The goal of this observational registry is to assess the use and performance of Galvanize PEF technology in a real-world setting. The main questions it aims to answer are:

* PEF utilization and performance
* Monitor safety outcomes and inform future generation devices.

Participants will undergo the PEF procedure and be followed per institutional standard of care.

This is a multi-center, observational registry that follows patients for a total of 2 years from the date of the Pulsed Electric Field (PEF) procedure with the FDA cleared Galvanize Technology.

Patients will be enrolled and followed prospectively or enrolled retrospectively with prospective, longitudinal follow up.

Enrollment for this study will include up to 200 patients throughout the US who underwent or are scheduled to undergo PEF energy delivery.

Eligibility Criteria:
Inclusion Criteria:

1. Subject will undergo or has undergone PEF energy delivery utilizing Galvanize technology
2. Subject is expected to be available for follow-up per the enrolling physician's standard care practices
3. For prospective cohort, subject has a life expectancy of at least 3 months; for retrospective cohort, subject has completed at least three months of imaging following the PEF procedure
4. Signed informed consent is obtained, if required by IRB

Exclusion Criteria:

None
Reducing Sedentary Time in Rheumatoid Arthritis: The Take a STAND for Health Study

This research program aims to comprehensively investigate the clinical, physiological, metabolic, and molecular effects of reducing sedentary behavior in rheumatoid arthritis. To this aim, we will conduct a 4-month parallel-group randomized controlled trial aiming to investigate the feasibility and efficacy of a newly developed personalized intervention focused on replacing sedentary time with light-(or very light-) intensity physical activity in rheumatoid arthritis. Additionally, a sub-sample of patients will complete a randomised cross-over study aiming to unravel potential mechanisms underlying the metabolic, physiological and molecular effects of breaking up sedentary time with light-intensity physical activity versus carrying out the minimum amount of daily exercise at once and then remaining sedentary versus simply remaining sedentary throughout all sessions, in a well-controlled laboratorial condition.


Eligibility Criteria:
Inclusion Criteria:

* Post-menopausal women diagnosed with rheumatoid arthritis

Exclusion Criteria:

* any physical disabilities that preclude physical exercise testing
* participation in structured exercise training programs within the last 12 months
* unstable dose of disease modifying drugs, including biological therapy, in the last 3 months prior to and during the study
A Study to Compare Nivolumab Drug Product Process D to Nivolumab Drug Product Process C in Participants With Stage IIIa/b/c/d or Stage IV Melanoma After Complete Resection

The purpose of this study is to compare the drug levels, immunogenicity and safety of Nivolumab Process D to Nivolumab Process C after complete resection of stage IIIa/b/c/d or stage IV melanoma.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed stage IIIa/b/c/d or stage IV melanoma
* Complete resection of Stage III disease that is documented on the surgical and pathology reports or complete resection of Stage IV disease with margins negative for disease that is documented on the pathology report
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1

Exclusion Criteria:

* Prior malignancy active within the previous 3 years, except for locally curable cancers that have been apparently cured
* Any significant acute or chronic medical illness that is uncontrolled
* History of ocular/uveal melanoma
* Active, known or suspected autoimmune disease
* Systemic treatment with either corticosteroids (\> 10 mg daily prednisone or equivalent) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement steroid doses \> 10 mg daily prednisone or equivalent, are permitted in the absence of active autoimmune disease.

Other protocol-defined inclusion/exclusion criteria apply
Observational Study on Contraception With Essure in France

Using a very broad survey, the objective is to confirm the effectiveness of the Essure method, and to obtain more information on the conditions of use as well as on the methods used during the 3-month check-up, as well as the 12-month, 24-month and 5-year follow-up on patients.

The study is a prospective epidemiological survey to collect local real life data on patients under routine pratice

Eligibility Criteria:
Inclusion Criteria:

* Woman ≥ 18 years old,
* Scheduled for Essure procedure
* Patient who has been given appropriate information about the study objectives and procedures and who has given her consent.

Exclusion Criteria:

* Patients with contraindications as listed in the current Instruction For Use (IFU) will be excluded.
Does Quality of Life Improve in Multiple Sclerosis Patients Treated With Interferon Beta-1a?

This study was to find out if patients with Relapsing Remitting Multiple Sclerosis treated with Interferon beta-1a had an improved quality of life after treatment with Interferon beta-1a

The study was an open-label, multi-center, international post-marketing study (phase 4). Eligible patients were interferon naïve patients suffering from relapsing MS. The duration of a subject's participation in the study was up to a maximum 26 months.

Eligibility Criteria:
Inclusion Criteria:

* Relapsing Remitting Multiple Sclerosis
* Interferon naïve
* Eligible for interferon beta-1a (AVONEX®) therapy as per Summary of Product Characteristics:
* Subject has had relapsing MS for \> 1 year
* Subject has had experienced 2 exacerbations in the last 2 years
* Subject had an EDSS \[5\] score of \< 5.5
* Subject was ambulant

Exclusion Criteria:

* Diagnosis of MS defined as progressive
* History of any significant cardiac, hepatic, pulmonary, or renal disease; immune deficiency; or other medical conditions that would preclude therapy with interferon beta
* History of severe allergic or anaphylactic reactions or history of hypersensitivity to human albumin
* History of seizures within the 3 months prior to starting this study
* History of intolerance to acetaminophen (paracetamol), ibuprofen, naproxen or other NSAIDs, that would preclude use of at least one of these during the study
* History of intolerance to interferons
* Previous use of interferon beta
* Female subjects who were pregnant or breast-feeding
* For female subjects, unless postmenopausal or surgically sterile, unwillingness to practice effective contraception
Safety and Efficacy of Dextromethorphan and Quinidine in the Treatment of the Pain of Diabetic Neuropathy

The purpose of this study is to determine whether dextromethorphan (Neurodex) and quinidine are effective in the treatment of pain of diabetic neuropathy.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of diabetes mellitus
* Established diabetic therapy for at least 3 months
* Lab-supported diagnosis of painful diabetic distal symmetric sensory/motor polyneuropathy
* Pain the previous three months
* Not pregnant

Exclusion Criteria:

* Patient failed adequate trial of 3 or more medications or has required narcotics for pain
* History of torsades de pointes
* Sensitivity to quinidine or opiate drugs (codeine, etc)
* Severe pain that could confound the assessment
* Patient has had any amputations
* Patient has participated in the past 30 days or is currently participating in another trial
* Patient has previously received treatment with dextromethorphan and quinidine
Pre-surgical Evaluation for the Quantra System in Adult Patients Undergoing Cardiac Surgery

This study will evaluate the performance of the Quantra System comprised of the Quantra Hemostasis Analyzer with the QPlus Cartridge in patients taking anitplatelet medication that are scheduled to undergo cardiac surgery.

The Quantra System is a fully integrated and automated in vitro diagnostic device which uses SEER Sonorheometry, an ultrasound-based technology, to characterize the viscoelastic properties of a whole blood sample during coagulation. The Quantra QPlus Cartridge was developed to monitor hemostasis during major surgical procedures in adult patients. The cartridge consists of four independent channels each containing different sets of reagents, which provide four measurements performed in parallel yielding six parameters that depict the functional status of a patient's coagulation system.

This single-site, prospective, observational study will evaluate the performance of the Quantra System as compared to standard coagulation tests and comparable measures determined using TEG in patients taking antiplatelet medication that are scheduled to undergo cardiac surgery.

Eligibility Criteria:
Inclusion Criteria:

* Subject is scheduled for elective cardiac surgery utilizing cardiopulmonary bypass, including the placement of a ventricular assist device
* Subject was identified as taking antiplatelet medication, specifically a P2Y12 inhibitor such that a TEG Platelet Mapping test is prescribed prior to surgery to assess possible platelet inhibition
* Subject is ≥ 18 years
* Subject is willing to participate and he/she has signed a consent form

Exclusion Criteria:

* Subject is younger that 18 years
* Subject is unable to provide written informed consent
* Subject is incarcerated at the time of the study
* Subject is pregnant
* Subject is currently enrolled in a distinct study that might confound the results of the proposed study
* Subject is affected by a condition that, in the opinion of the clinical team, may pose additional risks.