cyrilzakka/clinical-trials huggingface dataset:
Diabetic Macular Edema Treated With Ozurdex (DMEO)

To measure various pro-permeability factors in the aqueous humor of patients with persistent/recurrent diabetic macular edema

Patients with Diabetic Macular Edema (DME) are increasingly being treated with molecules targeting vascular endothelial factor (VEGF). One potential advantage of a dexamethasone implant over specific VEGF antagonists is that steroids suppress production of multiple pro-permeability factors.

Our primary objective is to measure the pro-permeability factors in the aqueous humor of patients with persistent/recurrent macular edema despite prior treatment with anti-VEGF agents at baseline and at 1, 2, 3, and 4 months after intraocular injection of a dexamethasone implant.

Eligibility Criteria:
Inclusion Criteria:

* • Signed informed consent and authorization of use and disclosure of protected health information

  * Age more than or equal to 18 years
  * Diagnosis of diabetic macular edema
  * Intraretinal or subretinal fluid in the macula determined by Spectralis OCT
  * Best corrected visual acuity score in the study eye of 20/30 to 20/400 inclusive (Snellen equivalents using the ETDRS protocol at a distance of 4 meters)
  * In the opinion of the investigator, decreased vision in the study eye is due to foveal thickening from DME and not from other obvious causes of decreased vision
  * Persistent or recurrent edema despite prolonged treatment with an anti-VEFG agent

Exclusion Criteria:

* • Scatter laser photocoagulation or macular photocoagulation within 3 months of study entry in the study eye

  * Intraocular surgery in the study eye within 3 months of study entry
  * Use of intraocular or periocular injection of steroids in the study eye (e.g., triamcinolone) within 4 months of study entry
  * Previous use of an anti-VEGF drug within 1 month of study entry
  * Yttrium-Aluminum-Garnet (YAG) laser capsulotomy within 1 month of study entry
  * Any condition that the investigator believes would pose a significant hazard to the subject if investigational therapy were initiated.
  * Inability to comply with study or follow up procedures
  * History of glaucoma. (Patients who have undergone filtration surgery may be included)
  * Patients with active or suspected ocular or periocular infection, including most viral diseases of the cornea and conjunctiva, including active epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, mycobacterial infections, and fungal diseases.
  * Aphakic eyes with rupture of the posterior lens capsule.
  * Eyes with ACIOL and rupture of the posterior lens capsule.
  * Patients with hypersensitivity to dexamethasone or to any other components of the product
Safety and Efficacy of FolateScan (Technetium Tc 99m EC20) in Subjects With Suspected Metastatic Renal Cell Carcinoma

The folate receptor (FR) is overexpressed by many different cancer types, including renal cell carcinoma. Besides helping in the diagnosis of cancer, a folate-targeted imaging agent could provide an effective method to identify folate receptor-positive (FR+) cancer patients that may benefit from folate-targeted therapy. Up to 40 subjects, with known or strongly suspected metastatic renal cell carcinoma with at least one target lesion detected by a diagnostic imaging procedure (e.g. ultrasonography, CT, or MRI), will be enrolled in this study.

The investigational new drug (FolateScan or Technetium Tc 99m EC20) is a folate-targeted diagnostic radiopharmaceutical designed to bind to the folate receptor. The folate receptor is a glycoprotein that is over-expressed in many types of cancer cells but it is only minimally distributed in normal tissues. Folate conjugates bind to the folate receptor with high affinity and are brought into the cell via endocytosis. In contrast, folic acid itself enters most normal cells via the reduced folate carrier, a pathway entirely inaccessible to folate conjugates. Therefore, these folate conjugates are specific to cancer cells.

Endocyte's folate-targeted delivery system was applied towards the targeting of a diagnostic imaging agent (111In-DTPA-Folate) to ovarian cancer tumors. This proof-of-principle study was designed to demonstrate the ability of folate to target drugs to folate-receptor-positive (FR+) cancer tissue.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must meet the following eligibility requirements to be enrolled in the study.

  1. Subject must be 18 years of age or older.
  2. Subject must have known or strongly suspected metastatic renal cell carcinoma with at least one target lesion as identified by ultrasonography, MRI, or CT.
  3. Subject must have good kidney function.
  4. Subject must provide written informed consent prior to enrollment.

Exclusion Criteria:

* Subjects must be excluded if any of the following conditions are present:

  1. Subject is pregnant or breastfeeding.
  2. Subject is simultaneously participating in another investigational drug study, excluding the follow-up phase.
  3. Subject has received an investigational agent within 7 days prior to enrollment.
  4. Subject is unable to tolerate conditions for radionuclide imaging.
  5. Subject has been administered another radiopharmaceutical that would interfere with the assessment of Technetium Tc 99m EC20.
Value of Ultrasonographic Enthesitis Assessment in Spondyloarthritis

The aim of the study is to determine how valuable ultrasonographic enthesitis to asssess disease activity, functionality and quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Spondyloarthritis patients that fulfill 2009 ASAS criteria

Exclusion Criteria:

* history of elbow, ankle or knee surgery, local injection at the examination sites within the six weeks, peripheral neuropathy, infection and wound at examination site
The Effect of Sensory Integration Balance Training on Children With ABI

This study aim to investagte the effectivness of sensory integartion balance training during gait training with obstecles and stimulation to different sensation, in comparission to gait training with obstecles without sensory stimulation among children with acuired brain injury


Eligibility Criteria:
Inclusion Criteria:

* Children with ABI, able to walk with or without assistance, GMFCS level I-III, aged 4-12 years old, with subjective symptoms of balance impairments, fear of falling and/or history of falls

Exclusion Criteria:

* Botox injections or tendon release surgery in the past six months
Arteriopathy and Endothelial Function

To determine whether fruit juice might reverse endothelial dysfunction and whether this reversibility has a prognosis value


Eligibility Criteria:
Inclusion Criteria:

* Peripheral arteriopathy
* Stable cardio-respiratory status

Exclusion Criteria:

* Dialysis
Nicotinic Modulation of Schizophrenia-like Information Processing Deficits in Healthy Subjects

This study examines the interactive effects of ketamine and nicotine.


Eligibility Criteria:
Inclusion Criteria:

* 18-50 years old
* Smokers
GnRHa for Luteal Phase Support in Long GnRHa Protocol Cycles

Evaluation of the effect of adding a single dose of gonadotropin releasing hormone agonist (GnRHa) as a luteal phase support on the outcomes of intracytoplasmic sperm injection (ICSI) following long GnRHa protocol

Endometrial preparation for embryo transfer (ET) will be started after oocyte retrieval by giving 800 mg/day natural progesterone vaginal supplement + 4 mg/day estradiol oral supplement. The patients will be randomly divided into 2 groups for luteal phase support: (i) Group A (GnRHa group) in which the luteal phase support will be continued by the same regimen started on the day of oocytes retrieval until 2 weeks after embryo transfer (ET) with subcutaneous administration of a single dose (0.2 mg) of GnRHa (Triptorelin) 6 days after oocyte retrieval, and (ii) Group B (control group) in which the luteal phase support will be continued only by the same regimen started on the day of oocytes retrieval until 2 weeks after ET

Eligibility Criteria:
Inclusion Criteria:

* Women subjected to ICSI through controlled ovarian hyperstimulation (COH) with pituitary downregulation by GnRHa.

Exclusion Criteria:

* Moderate or severe endometriosis.
* Hydrosalpinx.
* Uterine abnormalities.
* Myoma.
* Previous uterine surgery.
Clinical Procedures to Support Research in ALS

The purpose of the Clinical Procedures To Support Research (CAPTURE) study is to utilize information collected in the medical record to learn more about a disease called amyotrophic lateral sclerosis (ALS) and related disorders.

The study will consent patients with ALS or related disorders that are receiving care at a clinical center in the CReATe consortium that uses Epic as its electronic health record (EHR) system. The study aims to systematically gather a clinical dataset through the EHR using a standardized approach to characterize the natural history of ALS and related diseases.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of ALS or a related disorder (e.g. primary lateral sclerosis, progressive muscular atrophy).
* Receiving care at a clinical center that uses Epic as its EHR.
* Able and willing to provide informed consent (or informed consent obtainable from a designated proxy).

Exclusion Criteria:

* Inability to understand English and/or Spanish
Donor Derived Cell-free DNA and Rejection of Kidney Allografts

To assess the association of dd-cfDNA with the presence, activity and severity of allograft rejection, and determine whether dd-cfDNA adds value to standard of care monitoring parameters in detecting kidney allograft rejection.


Eligibility Criteria:
Inclusion Criteria:

* Recipients transplanted from a deceased or living donor, who undergone a kidney allograft biopsy with clinical, biological, histological and immunological data.
* Written informed consent at the time of transplantation for the center database

Exclusion Criteria:

* Combined organ transplantation
* Pregnant women
* Bone marrow transplant
Diagnostic Study of Quantitative Imaging and Spectroscopy in Patients With Multiple Sclerosis

OBJECTIVES: I. Determine by quantitative magnetic resonance imaging measurements the change in the total volume of brain parenchyma as well as its gray and white matter, T2 and enhanced T1 lesion volume, and the magnetization transfer ratio histogram parameters, and correlate these measurements with clinical measures of disability in patients with multiple sclerosis.

II. Measure the quantity of whole brain N-acetylaspartate in patients with multiple sclerosis and compare these values to those from age matched controls.

III. Determine the correlation between specific neuropsychological tests which assess global cognitive functioning and the quantitative measurements taken in these patients in this study.

PROTOCOL OUTLINE:

Patients undergo magnetic resonance imaging and spectroscopy with standard gadolinium contrast followed by neuropsychological testing every 6 months for 5 years. An equal number of age and sex matched healthy patients act as a control group and undergo magnetic resonance imaging and spectroscopy without standard gadolinium contrast every 6 months for 5 years.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

* Diagnosis of multiple sclerosis Relapsing-remitting defined as 2 exacerbations and a worsening of neurologic function over 1 day followed by at least 30 days of no progression OR Secondary-progressive defined as increase of at least 1.0 unit on Expanded Disability Status Scale (EDSS) in past 2 years with or without exacerbations

--Prior/Concurrent Therapy--

* Biologic therapy: Prior interferon beta 1A, 1B, or glatiramer acetate No concurrent interferon beta 1A, 1B, or glatiramer acetate
* Endocrine therapy: Concurrent oral and IV corticosteroids allowed

--Patient Characteristics--

* Performance status: EDSS no greater than 7.0
* Hematopoietic: No hematologic dysfunction including hemolytic anemia
* Hepatic: No hepatic dysfunction
* Renal: No renal dysfunction
* Cardiovascular: No cardiac pacemaker
* Other: Not pregnant or nursing Negative pregnancy test No intracranial clips, metal implants, or external clips within 10 mm of head No metal in eyes No known gadolinium texaphyrin allergy No known claustrophobia
Effects of an Internet Use Disorder and Internet Gaming Disorder Early Intervention Program

Background. In the last two decades Internet usage has grown vastly. Pathological Internet usage (IUD; Internet Use Disorder) is associated with severe mental health problems affecting social, academic and daily life functioning. Internet Gaming Disorder (IGD) has been already included in the DSM-V. Recently, the WHO declared to include Gaming Disorder (GD) in the upcoming ICD-11. Despite the increasing rates of adolescents with IUD and (I)GD, affected people are treated unsystematically and there is a lack of evidence based treatment programs. PROTECT+ is a low-threshold, cognitive behavioral short-term group intervention.

Methods. 54 patients, aged 9-19 years, received PROTECT+ intervention in Heidelberg, Germany. The PROTECT+ intervention group underwent a cognitive-behavioral 4-session group therapy. Follow-up data were collected at 1, 4, and 12 months after admission. Primary outcome was the change in (I)GD and IUD related symptoms at the 12-months follow-up. Secondary outcomes were changes in comorbid symptoms as well as in problem solving, cognitive restructuring and emotion regulation skills

Discussion. Treatment of IUD and IGD is still in its early stages. Recent reviews report increasing research on treatment but also a lack of well-designed studies and evidence based treatment programs. The PROTECT+ intervention is a theory driven and evidence based therapy program which is based on the PROTECT preventive intervention in school settings. In the intervention group a reduction of (I)GD and IUD symptom severity is expected over 12 months.


Eligibility Criteria:
Inclusion Criteria:

Adolescents aged 9 to 19 years Self-selection

Exclusion Criteria:

Severe comorbid mental health disorder
Study of VX-765 in Subjects With Treatment-resistant Partial Epilepsy

The purpose of this study is to determine the safety, tolerability, and efficacy of VX-765 in subjects with Treatment-resistant Partial Epilepsy


Eligibility Criteria:
Inclusion Criteria:

* Subjects that are male or female aged 18 to 64 years (inclusive) with a body mass index between 18 and 35 (kg/m2)
* Subjects must have a diagnosis and history of treatment resistant partial onset seizures for which they are taking 1 to 4 concomitant antiepileptic drugs (AED). Treatment resistance is defined as failure to achieve seizure freedom despite adequate use of 2 different AEDs. All AED doses must remain stable for 4 weeks prior to the Screening Visit and throughout the entire study
* Subjects must have had at least 1 electroencephalogram (EEG) consistent with partial epilepsy and a brain magnetic resource imaging (MRI) or computed tomography (CT) scan within 5 years of Screening Visit negative for other confounding conditions
* Subjects must have had at least 6 observable partial seizures in 6 weeks prior to randomization, with at least 1 seizure per week during 3 of the 6 weeks within the Baseline Period
* Subjects who are male or female must agree to use acceptable contraceptive methods as defined in the protocol
* Subjects who are in otherwise good health

Exclusion Criteria:

* Subjects with a history of non-epileptic transient alterations in consciousness
* Subjects who have a history of status epilepticus in the past 12 months
* Subjects whose seizure frequency cannot be quantified
* Subjects who have significant medical illness including kidney, liver, pulmonary or gastrointestinal disease; or unstable or poorly controlled conditions
* Subjects who have clinically significant psychiatric illness
* Subjects with a positive drug screen (excluding any allowed prescribed medications) and history of alcoholism or drug addiction within past 2 years
* Males subjects that have a female partner of childbearing potential who do not agree to use medically approved methods of birth control
* Male subjects that have a female partner who is pregnant, nursing, or is planning to become pregnant during the study period, or within 90 days of the last dose of study drug
* Female subjects who are pregnant or lactating, or who are of reproductive potential who do not agree to use medically approved birth-control methods
* Subjects with a current or prior history of illness precluding them from immunomodulatory therapy (e.g. history of recurrent infections)
* Subjects with active hepatitis B, hepatitis C, or human immunodeficiency virus (HIV)
* Subjects who have participated in any other clinical trials involving an investigational product or device and have received the last dose of study drug within 45 days or 5 half-lives of the Screening Visit
Neurogenic Myocardial and Lung Injury in SAH Patients

Up to this day, little is known whether the extent of brain damage in patients with SAH correlates with the degree neurogenic myocardial injury and neurogenic lung injury.

This is a prospective observational study designed to asses relationship between catecholamine surge and development of myocardial and lung injury in subarachnoid haemorrhage patients.

Multiple forms of brain damage, primarily, subarachnoid haemorrhage (SAH) are frequently accompanied by neurogenic myocardial injury with changes in the electrocardiogram, accompanied by the release of markers of myocardial injury. This form of cardiac dysfunction is thought to be mediated by cellular toxicity associated with catecholamine release. Central nervous system damage in the course of intracranial haemorrhage may, in a similar pathogenic pathway, lead to neurogenic lung injury. Up to this day, little is known whether the extent of brain damage in patients with SAH correlates with the degree of neurogenic myocardial injury. Moreover, it remains unknown what is the full clinical picture and duration of this type of myocardial injury and how often it co-occurs with neurogenic lung injury. Such analysis is a fundamental and most important step in optimising the treatment of these patients.

Methods: In this prospective observational study the authors aim to recruit 30 patients with subarachnoid haemorrhage, requiring hospitalization in the Intensive Care Unit. The patients will be monitored for elevation in cardiac damage markers (hs-TnT, CPK, CK-MB, NT-proBNP) and worsening of respiratory conditions, defined by need for more invasive ventilation parameters, and subsequent changes in arterial blood gas. The above mentioned parameters will be assessed every 12 hours. Additionally, the patients will be screened for an elevation in catecholamine metabolite (metanephrine) concentration in 12-hour urine collection.

Hypothesis to be tested: Myocardial and lung injury in SAH patients is timely-associated with an increase in metanephrine concentration in urine.

Eligibility Criteria:
Inclusion Criteria:

* patients with subarachnoid haemorrhage (both aneurysmal and non-aneurysmal) with acute consciousness disturbances (Glasgow Coma Scale \< 8 pts) requiring intubation and mechanical ventilation, hospitalized in the ICU for over 24 hours

Exclusion Criteria:

* severe prior pulmonary diseases
* severe prior cardiac diseases
* death in the first 72 hours of ICU stay
* need for any extracorporeal life-saving techniques
Intravenous Ascorbic Acid Administration in Hysterectomy

vitamin C or ascorbic acid has known role in tissue repair. due to it's properties(water_soluble), vitamin c is not stored in the body and when depleted, the bleeding tendency will increase due to dysfunctional connective tissues production in vessel wall and it has some important functions in platelets.

In this randomized clinical trial, 1000 mg vitamin C will administrate intravenously a day before surgery and during surgery in patients who undergo abdominal hysterectomy.

Eligibility Criteria:
Inclusion Criteria:

* To be 18 years and older
* No smoking
* No history of bleeding disorder
* No history of favism
* No history of uterus, ovary, cervical cancer

Exclusion Criteria:

* Need to injection of vasopressor drugs
* Surgeon disagreement
Erinacine A-enriched Hericium Erinaceus Mycelia for Improvement of Recognition, Vision, and Functional MRI Alterations

This study was designed as randomized double blind placebo study to investigate the efficacy of Erinacine A-enriched Hericium erinaceus mycelia for improvement of recognition, vision, and functional MRI alterations.

Patients were recruited with diagnosis of mild or medium dementia, according to criteria by NINCDS-ADRDA (National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association) as probable or possible Alzheimer's disease. Upon signature of informed consent, they were subject to: (1) Cognitive assessments, including Mini-Mental State Examination(MMSE), Neuropsychiatric Inventory (NPI), Cognitive Abilities Screening Instrument (CASI), and Instrumental Activities of Daily Living (IADL) on weeks 0, 12, 24, and 49, (2) Blood Markers Tests, including DHEAS, Alpha 1-antichymotrypsin, Superoxide Dismutase, and Homocysteine, Apolipoprotein E, Hemoglobin, Calcium, Albumin, and Amyloid Beta on weeks 0, 24, and 49, (3) fMRI Assessments for Super-resolution Track Density Imaging (TDI), and Blood Oxygenation Level-Dependent (BOLD) Signal Mapping, on weeks 0 and 49, (4) Vision Assessments, including Visual Acuity (VA) and Contrast Sensitivity (CS), on weeks 0, 24, and 49. Mann-Whitney U test and Wilcoxon tests were applied to examine the data before and after dietary intake of Erinacine A-enriched Hericium Erinaceus Mycelia after 49 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Aged between 50 and 90
* Confirmed diagnosis of mild and intermediate Alzheimer's disease based on clinical assessments according to criteria of NINCDS-ADRDA (National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association)

Exclusion Criteria:

* vulnerable to injuries
* loss of self-recognition,
* loss of behavioral capacity
* with critical illness
* with major diseases