cyrilzakka/clinical-trials huggingface dataset:
Structured Post-marketing Surveillance to Collect the Safety Data of Intravitreal Aflibercept Injection (IVT-AFL) in Patients of Wet Age-related Macular Degeneration During Real World Clinical Practice

The proposed regulatory post-marketing surveillance (PMS) study will be planned to collect the safety data of aflibercept intravitreal injection in patients with wet Age-related Macular Degeneration (AMD) in real-life treatment practice

The primary objective is:

- To collect safety data in wet AMD patients treated with intravitreal aflibercept injection

The secondary objective is:

- To determine how disease activity is monitored including type and frequency of ocular tests and frequency of injections

The study will be multicenter, observational, prospective, single arm, post marketing surveillance study of intravitreal aflibercept injection in wet AMD patients in routine clinical practice and real-life conditions without any protocol mandated interventions.

Approximately 100 wet AMD patients from up to ten ophthalmology clinics across India will be enrolled in this study. Each study site will be requested to enroll approximately 10 patients, however, the sites will be asked to enrolled additional patients in case of failure to enroll 10 patients by other site to complete the recruitment of approximately 100 patients.

Patients will be observed for maximum period of 6 months after the start of intravitreal aflibercept treatment. The observation period should cover the entire period from initial visit to the last follow-up visit at six months or withdrawal of consent, or the patient is lost to follow up (whatever is earliest).

The study site will be asked to enroll into the study all consecutive patients with wet AMD for whom the decision has been made to treat with intravitreal aflibercept injection and patients agrees to sign informed consent form for data collection purpose.

Any switch to another therapy or initiated administration of other anti-VEGF (Vascular Endothelial Growth Factor) injection in fellow eye or the discontinuation of treatment with IVT-AFL before the 6 month implies the end of the observation period. However, the safety follow-up will continue at least 30 days after last intravitreal aflibercept injection or in case of the discontinuation of treatment with IVT-AFL or till the patient switch the treatment from IVT-AFL and received other anti-VEGF injection before the 6 month observation period.

Eligibility Criteria:
Inclusion Criteria:

* Decision to treat with intravitreal aflibercept injection prior to patient enrolment as per the treating ophthalmologist's routine clinical practice.
* Adult patients with a diagnosis of wet AMD, as an indication approved by the local health authorities (DCGI) for use with intravitreal aflibercept injection.
* Patient or legal delegate signed informed consent.

Exclusion Criteria:

* Participation in a clinical trial of an investigational agent within 30 days.
* Patients receiving other anti-VEGF agent in fellow eye.
* Contraindications according to the local prescribing information.
Fecal Calprotectin for Prediction of Esophageal Varices in Cirrhotic Patients

The goal of this cross-sectional observational study is to evaluate the accuracy of fecal calprotectin versus non-invasive scores in assessing the presence and grading of esophageal varices in Egyptian patients.

Researchers will compare fecal calprotectin levels in cirrhotic patients with and without esophageal varices (EVs) and healthy subjects. researchers will also evaluate the performance of fecal calprotectin, AST to platelet ratio index (APRI) score, fibrosis-4 (FIB-4) score, albumin-bilirubin (ALBI) score, platelet-albumin-bilirubin (PALBI) score, and platelet-spleen diameter ratio (PSR) for predicting esophageal varices.

Participants will undergo history-taking, clinical examination, laboratory investigations, fecal calprotectin, abdominal ultrasonography, and upper endoscopy. Endoscopic grading of esophageal varices will be done using Paquet's classification. The APRI, FIB-4, ALBI, PALBI, and PSR scores will be calculated. The performance of fecal calprotectin for predicting EVs will be compared versus other non-invasive scores.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Liver cirrhosis

Exclusion Criteria:

* Patients aged \< 18 years.
* Inflammatory bowel disease.
* Infectious gastroenteritis.
* Malignancy.
* Patients on proton pump inhibitors or NSAID.
* Patients with spontaneous bacterial peritonitis.
* Patients with hepatic encephalopathy.
* Unwilling to participate in our study.
Quality of Life in Children With HIV Infection

The purpose of this study is to characterize the quality of life (QOL) and longitudinal patterns of change in QOL outcomes in children and youth with HIV infection; to identify demographic, social, disease status, treatment, and health care utilization factors that predict longitudinal changes in outcomes; to develop a conceptual model that characterizes the effects of specific factors that predict longitudinal changes in QOL; and to characterize the influence of HIV symptoms on QOL outcomes in the domains of health perceptions, physical, psychological, and social role functioning.

This is a Phase III study. This study will use national data available through a prospective, observational, longitudinal study of children and youth (n=1,993) from birth to 25 with HIV infection (Pediatric AIDS Clinical Trials Group Protocol 219/219C) to develop knowledge about the quality of life (QOL) and the factors that affect it in order to be able to implement effective nursing interventions and clinical programs to support and improve QOL in this vulnerable population of children.

Eligibility Criteria:
Inclusion criteria

* Children and youth with perinatally acquired HIV infection
* Enrolled in PACTG 219/219C
* Completed quality of life assessment

Exclusion criteria

--HIV exposed, not infected
Ultra-low-dose Chest CT for HHT

This study aims to develop a novel ultra-low dose chest CT technology for use in Hereditary Hemorrhagic Teleangiectasia (HHT) patients and to determine the lowest possible radiation dose that is achievable without sacrificing the diagnostic quality.


Eligibility Criteria:
Inclusion Criteria:

* Ages 1 to 17 years
* Diagnosed with positive HHT causing mutations or based on Curacao criteria

Exclusion Criteria:

* Acute respiratory distress
* Unstable cardiovascular status
* Pneumothorax, hemoptysis
* Pulmonary edema
* Pulmonary emboli
* Fractured ribs or other chest trauma
* Recent bronchoscopy
* Lung transplantation
Efficacy of Mictalase® After ThuLEP

In this single-center, prospective, randomized, open label, phase-III study, patients with indication to Thulium Laser Enucleation of Prostate were enrolled. The report conformed to CONSORT 2010 guidelines. Eligible patients were 1:1 randomized. Randomization defined Group A: patients who were administered Phenolmicin P3 and Bosexil suppositories twice a day for 5 days, then once a day for other 10 days; Group B: patients who did not receive the suppositories ("controls"). Study endpoints were evaluated at 15 and 30 days postoperation. Primary endpoint included evaluation of effects of the suppository on irritative symptoms by administering International Prostate Symptom Score (IPSS) with Quality of Life (QoL) questionnaire. Secondary endpoint included evaluation of effects on urinary tract infections by performance of urinalysis with urine culture.


Eligibility Criteria:
Inclusion Criteria:

- Patients with symptomatic benign prostatic hyperplasia deemed eligible for thulium laser enucleation of prostate.

Exclusion Criteria:

* patients with history of prostatitis,
* patients with history of neurogenic detrusor overactivity (as determined after urodynamic observation),
* patients diagnosed with prostate cancer,
* patients who underwent previous surgeries of the lower urinary tract,
* patients with indwelling catheter,
* patients with history of nephrolithiasis,
* patients with known or suspected hypersensitivity to Phenolmicin P3 and/or Bosexil
* patients experiencing occurrence of severe intraoperative complications.
Phase 1 Study of DDI Between DW330SR and DW1030 in Healthy Male Subjects

The purpose of this study is to evaluate drugs interactions to compare pharmacokinetics in groups of monotherapy DW330SR, monotherapy DW1030, and coadministration DW330SR and DW1030


Eligibility Criteria:
Inclusion Criteria:

* Healthy Adult males aged 20\~40 years at screening visit
* Subjects with range of 19 kg/m2 \~ 27 kg/m2 as BMI measurements at screening visit
* Subjects with BP range of below:

  90 mmHg ≤ Systolic BP ≤ 140 mmHg 50 mmHg ≤ Diastolic BP ≤ 90mmHg
* Subjects who voluntarily agreed with written consent that be able to understand the objective, method of the study, the characteristics of investigational drug, and comply with the reguirement of the study

Exclusion Criteria:

* Subjects with clinically significant disease or history such as Liver, kidney, gastrointestinal, respiratory, musculoskeletal, endocrine, nervous psychiatric, blood tumor system and cardiovascular. (In particular, bronchial asthma, severe hepatic, renal failure, severe blood disorders, severe myasthenia gravis, cardiac dysfunction, peptic ulcer, etc.)
* Subjects with history of gastrointestinal disease (ex, Chrones dz, peptic ulcer, etc) affect the absorption of Investigational drugs or history of surgery (except for a simple appendectomy or hernia surgery)
* Subjects with hypersensitivity reaction or clinically significant disease in drugs (Aspirin, NSAID and antibiotics) including ingredient of DW330SR and DW1030 and Food
Glycine Treatment of Prodromal Symptoms

This is an open label trial of the NMDA agonist glycine used alone for symptoms that appear to be prodromal for schizophrenia in adolescents and young adults.


Eligibility Criteria:
Inclusion Criteria:

* age 14-35
* meets SIPS criteria for psychosis prodrome

Exclusion Criteria:

* current antipsychotic medication
* more than 4 weeks of antipsychotic medication lifetime
Diet, Eating, and Lifestyle Improvement for Valued Employees and Their Relatives

Food is widely understood as a cornerstone of health, however multiple barriers stand between well-intentioned, well-informed consumers and the adoption of healthier dietary practices. This mixed-methods randomized controlled trial (RCT) will measure the impact of offering a Community Sustained Agriculture (CSA) share as an employee benefit on household food environments (diets), eating behaviors, and lifestyles.

Aim: We will test a strategy to increase frequency of cooking meals at home and consumption of healthful, fresh foods by providing study participants with a CSA membership.

Study design: This is a mixed method randomized controlled trial, with survey, home-food audit, and interview components.

Hypothesis: The intervention group who received a CSA membership as an employee benefit will prepare more meals at home and consume more healthful, fresh foods compared to the control group (no CSA participation).

Using both qualitative and quantitative assessments, outcomes will be measured using 3 primary measures:

1. Home food audits at baseline and at week 8 of the intervention. A random selection of participants will have home-food audits completed by members of the research team - those not randomly selected will complete the home-food audit themselves.
2. Self-administered surveys, including food frequency questionnaires, at baseline, week 8, and week 16.
3. Randomly selected participants will be asked to participate in qualitative interviews at the close of the 16-week intervention period.

Eligibility Criteria:
Inclusion Criteria:

* Individuals who are non-faculty employees at the University of Pennsylvania and University of Pennsylvania Health System.
* Individuals who score below the median (50th percentile) on dinners prepared at home on screening survey.

Exclusion Criteria:

* Individuals who are under the age of 18.
* Individuals who are already have a CSA membership.
Topical Nepafenac as Supplement for Diabetic Macular Edema

Diabetic macular edema (DME) is a major cause of visual loss in patients with diabetes mellitus. The standard treatment is with focal/grid laser therapy. Topical nepafenac was used as an adjunct therapy for treatment of DME.

The aim of this study is to compare the difference of best corrected visual acuity (BCVA) and central macular thickness (CMT) at 3 months post treatment between combination therapy of laser and topical nepafenac and laser monotherapy in patients with DME.

Diabetes mellitus with its systemic complications has been an enormous health treat to the world population today. In the US, the ophthalmic related complications has been estimated to cause up to 4.2 million (28.5%) people in 2005 till 2008 to suffer from blindness. One of the most common causes of visual acuity loss in patients with diabetes mellitus is diabetic macular edema (DME).

The gold standard of treatment for clinically significant macular edema (CSME), a form of DME, is through focal and grid laser as shown by the Early Treatment Diabetic Retinopathy Study. The development of newer drugs such as anti vascular endothelial growth factors anti (VEGFs), an alternative to laser treatment, has become a topic of interest in the recent years. Other alternative to treatment of DME is steroid such as triamcinolone injection and dexamethasone injections. However, both anti VEGFs and steroids are expensive and not readily available in all centres. Both types of medications require repeated treatment and the route of administration through intravitreal also poses risk of endophthalmitis, lens injury, retinal detachment, vitreous hemorrhage, increase in intraocular pressure and cataract.

The pathophysiology of DME is not fully understood yet. It was suggested that it is likely to be a chronic low-grade inflammation. Through this theory, topical non-steroidal anti-inflammatory drugs (NSAIDs) have been used to treat DME. The investigators postulate that the addition of topical NSAIDs in patients receiving standard treatment of laser therapy may help to improve the outcome of patients with DME. It has the advantage of no needles involved, convenient, easy to use and minimal side effects. The aim of this study is to evaluate the outcome of visual acuity and macular thickness at 3 months post treatment between laser monotherapy and combination of laser and topical nepafenac in DME.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 Diabetes Mellitus with CSME
* Aged 18 to 70 years old
* Clear media (Able to perform OCT)
* HbA1c less than 12% at 3 months

Exclusion Criteria:

* CSME with severe Non-Proliferative Diabetic Retinopathy (NPDR) or Proliferative Diabetic Retinopathy(PDR)
* Previous laser treatment
* Previous ocular injury or surgery
* History of taking topical or systemic anti inflammatory agents
* Allergic to NSAIDs
* Other ocular pathology (ARMD, Glaucoma, IPCV)
* High myope
Evaluation of 3D Surface Scanning for Virtual-CT Based Radiation Therapy Treatment Planning

This study evaluates if three dimensional (3D) surface images can be used instead of the standard computed tomography (CT) scans for treatment planning in electron radiation therapy. 3D scanning has previously been used by several groups to design patient-specific devices to be 3D printed, and as has shown excellent agreement with CT obtained surfaces. Using 3D surface imaging instead of x-ray based CT, benefits include: no ionizing radiation used to produce images, shorter time between patient consultation and treatment, and ability to produce and evaluate patient-specific devices for electron therapy earlier in the treatment planning process. This study may help researchers learn how 3D surface scanning may be used to produce a virtual CT image of patient surfaces, and accurately replace traditional planning CT for treatment planning of electron based radiation therapy.

PRIMARY OBJECTIVES:

I. Develop and benchmark the necessary software to convert a 3D scan to a virtual CT.

II. Compare the spatial accuracy of virtual CTs from 3D scans to the planning CT.

III. Compare radiation treatment plans based on the virtual CTs from aim 2 to treatment plans based on the actual planning CTs.

OUTLINE: This is an observational study.

Patients undergo 3D surface scans on study. Patient's medical records are also reviewed on study.

Eligibility Criteria:
Inclusion Criteria:

* Adults (18 years old or older)
* Capable of consent
* Receiving electron therapy and a planning CT scan
* Consent to two 3D surface scans of treatment area

Exclusion Criteria:

* Pediatric patients
* Mentally incapable of study consent
* Receiving electron radiation for a breast cancer boost
* Receiving electrons for total skin electron therapy
* Patients with epilepsy or other seizure disorders
METHOD - Bone Marrow Derived Mononuclear Cells in Chronic Ischemic Disease

Intramyocardial, NOGA guided injection of bone marrow derived mononuclear cells in patients with chronic ischemic heart disease and LVEF \< 40%. The primary objective is to determine whether the administration of the cells improves recovery of the left ventricular function. Secondary objective is the finding of clinical or paraclinical parameters to predict potential benefits of the treatment (basing on MRI characteristics such as size, transmurality of the myocardial infarction and peri-lesional ischemia).

In the first part of the study 10 patients are treated without control group. This phase serves as feasibility and safety part of the study.


Eligibility Criteria:
Inclusion Criteria:

* Chronic cardiac ischemic disease at least 4 months after one ore more myocardial infarctions in a stable phase of the disease without option for revascularization
* LVEF at echocardiography ≤ 40%
* Significant regional LV wall motion dysfunction in the infarct related territory
* Symptoms NYHA II-IV or CCS II-III (at least class III according to one of the two classifications)
* Patient agrees to comply with all follow-up evaluations
* Age \> 18 years old
* Patient has been informed of the nature of the clinical trial and agrees to its provision and has provided written informed consent

Exclusion Criteria:

* Abnormal regional wall motion outside the infarct region
* Need for revascularization in a non infarct-related coronary within 6 months
* Patient has moderate to severe aortic valve disease, aortic or mitral prosthetic valve
* Patient has a significant mitral valve insufficiency (Effective Regurgitant office - ERO - \> 0.2 cm2 with possibility of mitral valve surgery
* Left ventricular thrombus at echocardiography
* LV-aneurysma planned surgical aneurysmectomy
* LV-wall thickness \< 5mm in the target territory
* Congenital heart disorder of hemodynamic relevance
* Known active infection or chronic infection with HIV, HBV or HCV
* Chronic inflammatory disease
* Serious concomitant disease with a life expectancy of less than one year
* Follow up impossible (no fixed abode, etc)
* Contraindication for cardiac MRI (i.e. pace maker, neurostimulator, claustrophobia)
* Severe renal failure (creatinine \> 250 mmol/l)
* Relevant liver disease (GOT \> 2x norm or spontaneous INR \> 1,5)
* Anemia (Hb \< 8.5 mg/dl), Thrombocytopenia (\< 100.000/µl)
* Women of child bearing potential or pregnancy
* Participation at a clinical trial in the last 30 days
Factors to Obstructive Granulation Tissue Formation After Ultraflex Stenting in Benign Tracheal Narrowing

This study is aimed to determine factors leading to obstructive granulation tissue formation after placement of Self-Expandable Metallic Stent (SEMS) in patients with benign tracheal diseases.

From August 2001 to September 2007, patients with benign tracheal stenosis who underwent endoscopic tracheal stent placements at the Chang Gung Memorial Hospital, a university-affiliated hospital in Northern Taiwan, were evaluated.

Definition of airway conditions Dynamic collapse (tracheao-malacia) was defined as tracheal lumen narrowing on expiration under bronchoscopic examination. Structural tracheal stenosis was defined as tracheal stenosis excluding dynamic collapse. Etiologies of structural tracheal stenosis were post-intubation or tracheostomy, post-tuberculosis infection, granulation tissue formation cause previous SEMS re-stenosis, previous SEMS fracture, corrosive injury with stricture, mediastinitis cause airway stricture, and goiter compression.

Obstructive granulation tissue formation after SEMS implantation was defined as granulation tissue obstructing the lumen of the SEMS under bronchoscopic examination, including the proximal and distal ends.

Significant variables, such as structural obstruction airway before SEMS implantation was entered into a forward logistical regression analysis to determine the net effect of each predictor while controlling the net effects of others to obstructive granulation tissue formation. Obstructive granulation tissue formation curves between patients with and those without structural tracheal stenosis before SEMS implantation were compared by log rank test.

Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years,
* benign tracheal obstruction,
* receive Ultraflex metallic stent placement under flexible bronchoscopy.

Exclusion Criteria:

* malignant diseases,
* feasibility to receive surgical treatment or silicon stent placement.