cyrilzakka/clinical-trials huggingface dataset:
A Multiple Dose Study of Repeat Intravitreal Injections of GEM103 in Neovascular Age-related Macular Degeneration

This study is designed to investigate the safety and tolerability of GEM103 IVT injection + standard of care vs. sham + standard of care.

This is a Phase 2a, multi-center, multiple dose study in subjects with Neovascular Age-related Macular Degeneration (nAMD) to investigate the safety and tolerability of GEM103 IVT injection + standard of care vs. sham + standard of care.

Subjects will undergo clinical and ophthalmic assessments for determination of inclusion in the study and who meet all eligibility criteria will be enrolled.

Eligibility Criteria:
Inclusion Criteria:

1. At least 50 years old at the time of signed informed consent
2. Choroidal neovascularization (CNV) related to nAMD with the following features, as determined by the Image Reading Center

   1. Maximum CNV lesion size of 12 disc areas
   2. Subretinal hemorrhage less than or equal to (\<=) 50% of lesion size
3. On aflibercept treatment prior to Day 1
4. Best Corrected Visual Acuity (BCVA) in the study eye between 24 to 75 letters using EDTRS

Exclusion Criteria:

1. Presence of the following ocular conditions in the study eye:

   1. Any active ocular disease or condition that impact the subject to participate in the study or be a contraindication of IVT injections
   2. Any intraocular surgery
   3. Aphakia or complete absence of the posterior capsule
   4. Prior corneal transplant
   5. Scar or fibrosis greater than or equal to (\>=) 50% of CNV lesion or involving center of fovea
2. Presence of any of the following ocular conditions in either eye:

   1. History of herpetic infection, idiopathic polypoidal choroidal vasculopathy (PCV), pathologic myopia, central serous chorioretinopathy (CSCR), adult onset foveal pattern dystrophy
   2. Concurrent disease that could require medical or surgical intervention during the study period
   3. Active/suspected ocular/periocular infection or active intraocular inflammation
   4. History of idiopathic or autoimmune-associated uveitis
3. Any prior or ongoing medical condition or clinically significant screening laboratory value that may present a safety risk, interfere with study compliance, interfere with consistent study follow-up, or confound data interpretation throughout the longitudinal follow-up period
4. Has experienced a cardiovascular or cerebrovascular event within 12 months of informed consent
5. Females must not be pregnant or lactating
6. Current use of medications known to be toxic to the lens, retina or optic nerve
7. Use of any investigational new drug or other experimental treatment in the last 6 months prior to Day 1, and/or receipt of any prior gene therapy or ocular device implantation
Activation of Polyamine Catabolism in Patients With Acute Pancreatitis

Background: Polyamines are essential compounds in all mammalian tissues. If tissue spermidine/spermine levels, however, dramatically decrease, the cellular survival is severely endangered. Transgenic animals, where the homeostasis of cellular polyamines can be disturbed and tissue spermidine/spermine levels are decreased, acute pancreatitis evolves, indicating pancreas to be one of the most vulnerable organs for tissue polyamine catabolism. On the other hand, our own data suggests that also in other models of acute experimental pancreatitis pancreatic polyamines are changed depending on the severity of pancreatitis in such a way that the more severe pancreatitis the lower are the pancreatic polyamine levels. Minor changes were observed also in rats undergoing sham operation only. In addition of pancreatic enzymes, inflammatory mediators are also involved in the pathophysiology of the disease. CRP, IL-6, IL-8, IL-10 and Procalcitonin are useful in predicting the severity of the disease, combination of IL-6 and IL-10 at admission can predict organ failure with sensitivity of 95 %, specificity of 88 %.

Hypothesis: Similar to experimental pancreatitis, blood polyamine changes are associated with acute pancreatitis also in the man. These changes are dependent on the severity of pancreatitis, but not on the etiology of pancreatitis. The changes are specific to acute pancreatitis compared with other intra-abdominal emergencies. The changes observed return to baseline during recovery. Furthermore, we assume that blood polyamine negatively correlates with IL-6, IL-8, and procalcitonin, and positively with IL-10.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are diagnosed as acute pancreatitis.
* Patients who are diagnosed as either of gallstone, duodenal ulcer or bleeding, gastric ulcer or bleeding, irritable bowel syndrome, hernia, diverticulitis, retrocecal appendicitis with non-pancreatic acute abdominal pain.

Exclusion Criteria:

* Patients who underwent operation
* Patients who underwent recurrent acute pancreatitis
Prevalence of Seroconversion of Hepatitis c Virus Among Children With CKD on Regular Hemodialysis

observational cross sectional study for children with chronic kidney disease who on regular hemodialysis in assiut univeristy children hospital at dialysis unit, observe prevalence of serological seroconversion of hepatitis c virus and associated risk factors

Hepatitis C virus (HCV) is a blood-borne pathogen that appears to be endemic in many parts of the world,the highest prevalence of HCV has been found in Egypt (17-26%) The prevalence of HCV infection is higher in most subgroups of chronic kidney disease (CKD) patients than in the general population.

As there is very little known about HCV infection in infants and children with CKD and this very limited information implies that the current guidelines do not apply directly and completely to this specific population, and as the Kidney Disease Improving Global Outcomes (KDIGO) has recommended that pediatric nephrologists and other physicians - in charge of caring for children with CKD - should carefully evaluate the extent to which the current guidelines may be extrapolated to children.

Hepatitis C virus (HCV) infection is a significant cause of morbidity and mortality in hemodialysis patients and observed as a major public health problem infecting 170 million people globally and hepatitis C virus (HCV) infection is one of the most common blood-borne infections in Egypt, a large number of egyptians are exposed to infection due to low hygiene and sterilization measures in our community The Patients who undergo maintenance hemodialysis (HD) treatment are at increased hazard of getting these infections and have a greater prevalence of HCV than the general population due to underlying impaired cellular immunity which increases their susceptibility to HCV infection the hemodialysis patients are exposed to prolonged vascular access and exposure to contaminated equipment and handling by medical staff, In addition the CKD patients require frequent blood transfusion to recover the anemia related with chronic kidney disease and this blood transfusion make a source for HCV infection The inadequate sterilization of medical equipments, invasive dialysis procedures, mode of dialysis, contaminated blood and blood products, duration of end stage kidney disease, sharing of dialysis equipment, insertion of an intravascular catheter and contact with contaminated HD equipments and supplies during hemodialysis, all these risk factors help in HCV infection in hemodialysis patients.

In this study, the prevalence of seroconversion of hepatitis c virus among children with CKD on regular hemodialysis is to be assessed and its possible risk factors related to it

Eligibility Criteria:
Inclusion Criteria:

1. Age: from 1 year to 18 years
2. CKD children on regular hemodialysis for more than one month duration

Exclusion Criteria:

* 1-Age: less than 1 year and more than 18 years 2- CKD children who are not on regular hemodialysis and for less than one month duration
A Study of Tirzepatide (LY3298176) in Healthy Participants

This study has four parts. Each participant will enroll in one part.

Part A: The purpose of Part A is to compare study drug tirzepatide solution formulation to a powder formulation mixed with water and given subcutaneously (SC) (just under the skin). Part A will measure how much of the study drug gets into the blood stream and how long it takes the body to get rid of it.

Part B: The purpose of Part B is to evaluate the safety and tolerability of tirzepatide intravenous (IV) formulation when administered into a vein.

Part C: The purpose of Part C is to evaluate the safety and tolerability of tirzepatide following multiple SC weekly doses of a solution.

Part D: The purpose of Part D is to evaluate the safety and tolerability of tirzepatide following single IV bolus dose of lyophilized formulation.

This study will last approximately 70 days for each part (Part A, Part B or Part D) and 92 days for Part C. This does not include screening. Screening is required within 28 days prior to the start of the study.


Eligibility Criteria:
Inclusion Criteria:

* Overtly healthy males or females, as determined by medical history and physical examination
* Male participants: agree to use an effective method of contraception for the duration of the study and for 3 months following the last dose of investigational product
* Female participants: not of childbearing potential due to surgical sterilization (hysterectomy or bilateral oophorectomy or tubal ligation) or menopause. Women with an intact uterus are deemed postmenopausal if they are greater than or equal to (≥)45 years old and have not taken hormones or oral contraceptives within the last year and had cessation of menses for at least 1 year. Or, have had at least 6 months of amenorrhea with follicle-stimulating hormone levels consistent with a postmenopausal state
* Have a body mass index of 18.5 to 32.0 kilograms per meter squared (kg/m²) inclusive

Exclusion Criteria:

* Currently enrolled in a clinical trial involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study
* Received treatment with a drug that has not received regulatory approval for any indication within 30 days of screening
* Have a history of heart block, or a pulse rate (PR) interval greater than (\>)200 milliseconds (msec), or any abnormality in the 12-lead electrocardiogram (ECG) at screening that, in the opinion of the investigator, increases the risks associated with participating in the study
* Have a significant history of or current cardiovascular (myocardial infarction, congestive heart failure, cerebrovascular accident, venous thromboembolism, etc.), respiratory, hepatic, renal, gastrointestinal (GI), endocrine, hematological (including history of thrombocytopenia), or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs, or of constituting a risk when taking the study medication, or interfering with the interpretation of data
HCV Tappt Adherence Study

The goal of this non-inferiority clinical trial is to evaluate the efficacy of Tappt, a novel digital medication companion solution, among individuals with hepatitis C virus (HCV) who are starting a daily oral medication regimen following standard of care in a clinical pharmacy setting.

* The primary aim is to assess the non-inferiority of Tappt with medication adherence, treatment completion, sustained virologic response (SVR) assessment, and SVR achievement rates.
* The secondary aim is to assess the efficacy of Tappt at enabling pharmacists to personalize treatment and management decision based on participants' reported barriers to adherence, care, and SVR achievement.

Participants will download and utilize the Tappt app to record adherence to oral medication. For the purposes of this study, adherence for participants in the intervention arm will be measured using a modified medication possession ratio (MPR) measure called medication tag scan ratio (MTSR). MTSR is defined as a percentage of the number of times participants scanned their passive tags versus the total of expected tag scans based on that participant's medication regimen and treatment period.

Upon study completion, a retrospective matched control will be established for the intervention group. Historic data for the matched control's adherence, treatment completion, SVR assessment, and SVR rates will be compared to the intervention arm.


Eligibility Criteria:
Inclusion Criteria:

1. 18 years of age or older
2. Hepatitis C virus (HCV) infection (denoted by positive HCV antibody and detectable HCV RNA)
3. Initiating oral HCV therapy with glecaprevir/pibrentasvir or sofosbuvir/velpatasvir
4. HCV treatment provided and managed by the clinical pharmacist at UI Health
5. Access to a mobile smartphone (iPhone 7 or later; Android release date 2012 or later) with reliable data and/or Wi-Fi access
6. Ability to verbalize understanding of the study protocol in English
7. Able and willing to provide informed consent in English

Exclusion Criteria:

1. Inability to speak and read English
2. Inability or unwillingness to adhere to the study protocol
3. Pregnant individuals
4. Decompensated cirrhosis (Child Turcotte Pugh Class B and C); hepatocellular carcinoma; prior liver or kidney transplant

No patient will be excluded because of gender, race or ethnic origin.

The following populations will be excluded from the study:

* Adults 18 years of age and older who are unable or unwilling to consent
* Individuals less than 18 years old
* Pregnant individuals
* Prisoners
Tailored Intervention to Improve Medication Adherence in Patients With Hypertension

Patients with hypertension have an increased risk of stroke and myocardial infarction. However, poor adherence to treatment with antihypertensives and lipid-lowering agents occurs frequently within this patient group. The purpose of this study is to investigate whether a complex tailored intervention in a hospital setting will lead to increased medication adherence and fewer cardiovascular events when compared to a usual care group. Interventions focus on motivational interviewing, medication review and telephone follow up.


Eligibility Criteria:
Inclusion Criteria:

Age: 18 years or older

* Patients receiving ambulatory treatment for hypertension in a hospital setting
* The patient or a carer usually dispenses the patient's medications
* Patient lives in the Southern Region of Denmark
* Written consent

Exclusion Criteria:

* Lives in a care home or institution
* Receive dose dispensed medicine from a pharmacy
* Medicine is dispensed by a nurse in the patient's home
* Correctional mental health patients
The Role of Cytokine-Serotonin Interactions in Post-Stroke Depression

Depression is a common and often serious problem occurring in stroke patients. Inflammatory hormones, known as cytokines, are stimulated by an activated immune system and sometimes become active following a stroke. They may be responsible for altering levels of key neurotransmitters and their metabolites in the blood and brain of stroke patients. The investigators' objective is to examine whether increased cytokine activity following a stroke may be the cause of an increased presence or severity of depression or cognitive impairment among stroke patients, as a result of tryptophan depletion and/or kynurenine activation. They are recruiting patients within one month of their strokes and measuring levels of key markers in their blood. Patients are assessed for the presence of depressive and/or cognitive symptoms and treated with an antidepressant if needed. The investigators expect to show that cytokine activation is related to depression and/or cognitive impairment among stroke patients.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Gender: male or female
* Language: speaks and understands English
* Clinical diagnosis of stroke according to World Health Organization MONICA Project and recent (\< 3 months) cerebral infarctions
* Written, informed consent
* Depressed group only: diagnosis of a major depressive episode according to the depression module of the Structured Clinical Interview for the DSM-IV (SCID-IV)

Exclusion Criteria:

* Subarachnoid hemorrhage
* Intracranial hemorrhage
* Significant acute medical illness including: drug overdose, severely disturbed liver, kidney or lung function, anemia, hypothyroidism, or uncontrolled diabetes
* Significant acute neurologic illness including: impaired consciousness, Parkinson's disease, Huntington's chorea, progressive supranuclear paralysis, brain tumor, subdural hematoma, multiple sclerosis, hydrocephalus, Binswanger's disease, or severe aphasia
* Presence of a premorbid Axis I psychiatric diagnosis (eg. schizophrenia, bipolar disorder)
* Depressed group only: contraindications to receiving treatment with citalopram (including previous nonresponse) or serious risk of suicide
The Effect of Mitomycin C on Corneal Haze and Scarring After Corneal Crosslinking in Keratoconus Patients

Corneal crosslinking (Crosslinking, CXL) is a treatment offered for the stabilization of early corneal ectatic disorders such as keratoconus. Although CXL is an excellent treatment option to stabilize early ectatic corneas, complications include corneal haze, sterile infiltrate, endothelial cell toxicity, treatment failure and stromal scarring. Corneal haze is a common finding in almost all CXL patients and may decrease visual quality. The effect of 0.02% mitomycin C (MMC) for 2 minutes on corneal haze and scarring in refractive surgery is well established in the literature with many clinical studies confirming its effectiveness. Although the pattern of corneal haze after CXL appears to be different from the haze pattern seen following refractive procedures, both processes are thought to be caused by an inflammatory response.

The investigators postulate that MMC can reduce post-CXL haze and scars when using the optimal concentration and duration of exposure.


Eligibility Criteria:
Inclusion Criteria:

* Patients from both genders with confirmed keratoconus with evidence of clinical and topographic progression.
* Patients with the diagnosis of other ectatic disorders such as post refractive surgery ectasia with evidence of clinical and topographic progression.

Exclusion Criteria:

* Patients who are pregnant
* Patients who are breast-feeding
* Patients who have allergy to MMC
* Patients with other corneal conditions such as limbal stem cell deficiency (LSCD)
* Patients with peripheral marginal keratitis
* Patients with history of corneal melting
* Patients with history of HSV/VZV keratitis
* Patients with history of hydrops
Endoscopic Biliary Drainage in Malignant High Grade Biliary Stricture

Biliary drainage is the mainstay of the palliative treatment in patients with inoperable malignant bile duct stricture. Endoscopic retrograde cholangiopancreatography (ERCP) is the cornerstone of biliary drainage method in these patients. However, ERCP is sometime unsuccessful to perform because of the presence of the high grade biliary stricture, tumor invasion of duodenum and ampulla of vater and surgically altered gastrointestinal anatomy. Endoscopic ultrasound (EUS) guided biliary drainage has been emerged as an alternative procedure to traditional surgical bypass and percutaneous trans hepatic biliary drainage after failed ERCP. There were few data to directly compare between ERCP and EUS guided biliary drainage and in patients with malignant high grade biliary stricture.

The aim of this study is comparing the efficacy and complications between ERCP and EUS guided biliary drainage in patients with malignant high grade biliary stricture. Malignant high grade biliary stricture has not been well defined. The investigators define this malignant high grade biliary stricture using these arbitrary number include total bilirubin ≥ 15 mg/dl and or bile duct diameter ≥12 mm. based on the investigation's experience.

The study will be divided patients with inoperable malignant high grade biliary stricture into 2 groups, group (A) will be undergone ERCP with biliary stenting and group (B) will be undergone EUS guided biliary drainage. If the assigned intervention is not successful, then patients will be crossed-over to the another intervention.

Eligibility Criteria:
Inclusion Criteria: I) Patients aged \> 18 years. II) Clinical, laboratory data, imaging and or histology suggestive of malignant distal bile duct strictures that occurs as a result of pancreatic adenocarcinoma, cholangiocarcinoma, ampullary carcinoma, duodenal carcinoma, gallbladder cancer and metastasis malignant bile duct obstruction III) Inoperability by tumor staging, medically unfit or patient wishes

1. distant metastasis
2. major vascular involvement (unreconstructible Superior mesenteric vein/Portal vein, superior mesenteric artery, common hepatic artery and celiac artery)
3. metastasis to lymphnode beyond the field or surgery IV) Jaundice, total bilirubin ≥15 mg/dl and/ or Common bile duct diameter ≥12 mm

Exclusion Criteria: I) pregnancy II) uncorrectable coagulopathy ( international normalized ratio ≥ 1.5 ) III) thrombocytopenia (platelet count \< 50,000 ) IV) extremely poor general condition, ERCP with stent insertion impossible for ethical reasons V) an extension of stricture to the main biliary confluent (hilum) or the existence of obstructive duodenal invasion VI) active suppurative cholangitis VI) surgically altered anatomy (i.e. Billroth II or Roux-en-Y reconstruction ) VII ) previous treatment with bile duct stent.
Mobile Technology and Data Analytics to Identify Real-time Predictors of Caregiver Well-Being

The purpose of this study is to test whether personalized messages from an easy-to-use mobile app improve mood and stress among care partners and to see if care partners like using the app.


Eligibility Criteria:
Care Partner Inclusion Criteria:

* Provide emotional, physical, and/or financial support/assistance to an individual with spinal cord injury (SCI), Huntington's Disease (HD), or hematopoietic cell transplantation (HCT)
* Have access to necessary resources for participating in a technology-based intervention (smartphone/tablet and internet access) and be willing to use their personal equipment/internet for this study, including downloading the study app and the Fitbit® app on their mobile device
* Care partners of persons with HD: Be caring for an adult (18 years or older) with a clinical diagnosis of HD
* Care partners of persons with SCI: Be caring for an adult (18 years or older) that is ≥1 post-injury and sustained a medically documented SCI at age 16 or older
* Care partners of persons with HCT: Be caring for an adult (18 years or older) who is receiving, has received or is scheduled to receive HCT

Exclusion Criteria:

* Is a professional, paid caregiver (e.g., home health aide)