cyrilzakka/clinical-trials huggingface dataset:
To Evaluate the Safety and Preliminary Efficacy of Intravitreal EXG202 Injection in Patients with Wet (neovascular) Age-related Macular Degeneration (wAMD)

The goal of this clinical trial is to evaluate the safety, tolerability and efficacy of intravitreal injection of EXG202 in subjects with neovascular age-related Macular Degeneration (nAMD).

EXG 202 is a gene therapy product developed for the treatment of neovascular age-related macular degeneration (nAMD). Neovascular AMD is the main cause of blindness among elderly individuals. The available therapies for treating nAMD require life-long intravitreal (IVT) injections every 4-12 weeks to maintain efficacy. Administration of EXG202 has the potential to treat nAMD by providing durable expression of therapeutic levels of intraocular protein and maintaining the vision of patients. EXG 202 is designed to reduce the current treatment burden which often results in undertreatment and vision loss in patients with nAMD receiving anti-VEGF therapy in clinical practice.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female, aged ≥50 years old;
2. The study eye must meet the following criteria:

   A. Diagnosed of wAMD and current active lesions; active, defined as the presence of any of the following lesions in the macular area upon OCT examination: a) intraretinal hemorrhage or fluid; b) subretinal fluid; c) subretinal hemorrhage; B. The BCVA score tested during screening using the ETDRS eye chart (see Appendix 3 for details) must be between 73-19 letters (including boundary values), (equivalent to Snellen visual acuity of 20/40 to 20/400);
3. Clinically meaningful response to standard anti-VEGF therapy within 6 months before screening or during the lead-in period of screening.
4. The subject has clear refractive media and sufficient pupil dilation at the time of screening to obtain high-quality retinal images for confirmation of diagnosis;
5. Subjects (including male subjects) have no pregnancy plans during the screening period and the entire trial period and voluntarily take effective contraceptive measures and have no sperm or egg donation plans;
6. Voluntarily participate in this clinical trial, understand the research procedures and sign the informed consent form before screening; have good compliance and are willing to abide by the research procedures.

Exclusion Criteria:

1. The study eye has any eye disease other than wAMD that may affect central vision and/or macular detection (such as macular hole, macular epiretinal membrane, etc.);
2. The study eye has a history of retinal detachment or retinal detachment during the screening period (such as rhegmatogenous retinal detachment, tractional retinal detachment, etc.);
3. The study eye has MNV caused by reasons other than wAMD (such as diabetic retinopathy, pathological myopia, retinal vein occlusion, angioid streak disease, ocular histoplasmosis, trauma, etc.), and a history of macular pathology unrelated to wAMD;
4. The study eye plans to undergo any intraocular surgery during the study period;
A Comparison of Epivir Plus Crixivan Combined With Zerit or Retrovir in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs

To evaluate the tolerance, and comparative virologic and immunologic effects of the two combination regimens.

100 patients will be randomized to receive Zerit (Stavudine) + Epivir (Lamivudine) + Crixivan (Indinavir) and 100 patients will be randomized to receive Retrovir (Zidovudine) + Epivir (Lamivudine) + Crixivan (Indinavir).

Patients will be treated for 48 weeks.

Eligibility Criteria:
Inclusion Criteria

Patients must have:

* Documented HIV infection.
* CD4 cell count of 200 - 700 cells/mm3.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

AIDS defining condition within 1 month of study entry.

Prior Medication:

Excluded:

Patients with any history of antiretroviral therapy treatment.
Jet Injection of 1% Buffered Lidocaine Versus Topical ELA-Max for Anesthesia Prior to Intravenous (IV) Catheterization in Children

This trial is a comparison of the anesthetic effectiveness of J-Tip needle-free jet injection of 1% buffered lidocaine to the anesthetic effectiveness of topical 4% ELA-Max for peripheral intravenous catheter (PIV) insertion. The researchers hypothesize that the jet injection of lidocaine will provide superior anesthesia to the ELA-Max prior to PIV insertion.

A prospective, block-randomized, controlled trial comparing J-Tip jet injection of 1% buffered lidocaine to a 30-minute application of 4% ELA-Max for topical anesthesia in children 8-15 years old presenting to a tertiary care pediatric emergency department for PIV insertion. All subjects recorded self-reported Visual Analogue Scale (VAS) scores for pain at time of enrollment and pain of PIV insertion. Jet injection subjects also recorded pain of jet injection. Subjects were videotaped during jet injection and PIV insertion. Videotapes were reviewed by a single blinded reviewer for observer-reported VAS pain scores for jet injection and PIV insertion.

Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 8-15 years requiring a PIV as part of their management in the emergency department.

Exclusion Criteria:

* Excluded from the study if they reported use of analgesic medication within 6 hours of enrollment,
* Had a Glasgow Coma Score \< 15,
* A baseline screening VAS pain score \> 20 mm, or
* A history of skin hypersensitivity or lidocaine allergy,
* Were incapable of self-reporting a pain score,
* Had a known neurological condition that alters pain perception,
* Had methemoglobinemia, or
* Did not speak or understand English.
Low-Level Laser Therapy vs. Saline for Wound Healing After Primary Molar Extraction.

To evaluate the effect of low level laser therapy versus the saline on wound healing after extraction of primary Molars


Eligibility Criteria:
Inclusion Criteria:

* ● Children aged from 4 to 6 years.

  * Children of both genders.
  * Medically fit ASA I.
  * Children with badly decayed primary molars beyond repair and indicated for extraction.
  * Parents acceptance to participate in the study.
  * Cooperative children.
  * Antibiotics and painkillers have been stopped at least 12 hours prior to the procedure.(Özer et al., 2024)
  * Teeth with at least two-thirds of the root.

Exclusion Criteria:

* ● Uncooperative children.

  * Lack of informed consent by the child patient's parent to be approved ethically.
  * Unable to attend follow-up visits to avoid attrition bias by decreasing the number of drop off cases.
  * Medical history includes conditions such as prolonged bleeding, platelet disorders, hypersensitivity, allergic reactions to pain relievers, contraindications to laser therapy, and acute pain.
  * Teeth with root lengths less than two-third of the normal root length or those who experienced extensive iatrogenic trauma during tooth extraction.
Bioequivalence Study Of Phenytoin Suspension Versus Epamin® In 34 Healthy Volunteers.

Mexican healthy volunteers will receive the current form of the drug (under the name of Epamin) as well as Pfizer's compound (Phenytoin). Bioequivalence will be tested.

Bioequivalence

Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive
* A Body Mass Index (BMI) of 18 to 26.9 kg/m2 or ± 10% variation of the ideal weight; and a total body weight \>50 kg (110 lbs)
* An informed consent document signed and dated by the subject or a legally acceptable representative.

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing)
* Any condition possibly affecting drug absorption (eg, gastrectomy)
* A positive urine drug screen.
Optina Eye to Heart Connection

This is a prospective cross-sectional, single-center retinal imaging study expecting to enroll approximately 400 male and female subjects ≥ 18 years of age. Subjects having undergone clinically-indicated coronary angiography or coronary computed tomography angiography (CCTA) within one month of consent at the Montreal Heart Institute (MHI) will be screened for inclusion in the study.

This is a prospective cross-sectional, single-center retinal imaging study expecting to enroll aproximately 400 (280 CAD and 120 control) male and female subjects ≥ 18 years of age. Subjects having undergone clinically-indicated invasive coronary angiography or coronary computed tomography angiography (CCTA) within one month of signed consent will be screened for inclusion in the study.

Subjects will be recruited at the Montreal Heart Institute (MHI). During the screening visit, the investigator will review inclusion/exclusion criteria and the following information will be collected: demographic data including age and sex, relevant medical history including risk factors (hypertension, diabetes, dyslipidemia, smoking and obesity), history of CAD, concomitant cardiovascular medications and laboratory tests (lipid profile, fasting glucose) Subjects who provide written informed consent will undergo cognitive evaluation and an ophthalmic examination to identify any ocular exclusion criteria. All eligible subjects will then undergo hyperspectral retinal imaging using a Metabolic Hyperspectral Retinal Camera (MHRC)

Safety will be assessed through reporting of serious adverse events (SAEs) related to retinal imaging procedures.

Eligibility Criteria:
Inclusion Criteria:

* Ability and willingness to give written informed consent
* Age 18 years or older at the time of informed consent
* Stable (non-emergent) typical or atypical symptoms suspicious for CAD (e.g., chest pain, chest tightness, chest burning, shoulder pain, palpitations, jaw pain, or non-chest pain symptoms such as dyspnea or worsening effort tolerance.
* Patients having undergone clinically-indicated invasive coronary angiography or coronary computed tomography angiography within one month before consent signature

Exclusion Criteria:

1. At Screening Visit 1:

   1. Asymptomatic subjects
   2. Previous coronary revascularization (e.g., coronary artery bypass graft surgery, stenting)
   3. Subjects being evaluated for other cardiac diseases (e.g., valvular disease, cardiomyopathy)
   4. Pregnant or breastfeeding women
2. At Study Visit 2 or Ocular Exclusion Criteria:

   1. Medium or high opacity of the lens
   2. Bleeding in vitreous
   3. Pupillary dilation inadequate or contraindicated
   4. Deficient visual fixation
   5. Refractive error outside of the range -15 to +15
   6. Inability to obtain satisfactory images with the MHRC
Asthma in Children

This is a six-month non-interventional prospective study of various controller therapies in children with asthma in outpatient clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* Child (male or female) aged 5 to 11 years inclusive
* Provision of Subject Informed Consent Form for anonymous data collection and their subsequent use (must be signed by any of the parents)
* The child must be included in an out-patient observation program at a medical institution for established bronchial asthma diagnosis for at least 1 year prior to enrolment and diagnosed with moderate to severe bronchial asthma at the time of enrolment
* The child must have at least one documented bronchial asthma exacerbation in previous 1 year (including hospital admissions for bronchial asthma exacerbations, any cases of daytime hospital treatment without overnight stays and any cases of oral administration of glucocorticoids on an out-patient basis for \> 3 consecutive days)
* Out-patient receiving step 3 controller treatments with fixed dose combinations of ICSs and LABA or treatment with separate administration of glucocorticoids and LABA in stable doses with adequate control of bronchial asthma symptoms
* The patient administered with short-acting β2 agonists (inhalational) or rapidly released methylxanthines (oral) in the doses approved for the respective age as a rescue on-demand therapies during the preceding month

Exclusion Criteria:

* Cystic fibrosis, α1-antitrypsin deficiency or congenital abnormalities of lung development
* Severe comorbidities affecting the patient's overall performance
* In the physician's opinion, the patient is not able to comply with the protocol requirements
* Expected specific hyposensibilization within next 6 months
* Expected treatment at health resort facilities within next 6 months
* Other reasons that in the physician's opinion will prevent reliable assessments of the study treatment efficacy
Treatment Outcomes of Esophageal Cancer

This study will be a carried out through a prospective observational cohort design in conjunction with researchers in the African Esophageal Cancer Consortium (AfrECC). The purpose of this research is to prospectively evaluate outcomes related to existing treatment strategies for esophageal cancer (EC) at participating sites within AfrECC.

SPECIFIC AIMS:

Aim 1: To describe the types of treatments administered for all patients diagnosed with EC at participating AfrECC sites, including chemotherapeutic regimens, radiation therapy, chemo-radiotherapy, esophageal stenting, esophagectomy, and basic supportive care.

Aim 2: To evaluate the effect of different EC treatment modalities on patient reported outcomes during and after completion of treatment.

Aim 3: To measure the effect of different treatment modalities on overall survival.

Eligibility Criteria:
Inclusion Criteria:

* Participants with histopathologically confirmed or presumptive clinical diagnosis of EC. For patients who do not have histopathologically confirmed disease, presumptive clinical diagnosis may be based upon barium swallow or endoscopy without biopsy.
* Age 18 years of age or older;

Exclusion Criteria:

* Unable to provide informed consent
Efficacy of Parecoxib Combined With Paracetamol in Mastectomy

Patients undergoing breast cancer surgery experience persistent pain after surgery and subsequent development of chronic pain. Parecoxib or paracetamol has been reported to reduce postoperative pain in mastectomy. The investigators aim to assess the effectiveness of the perioperative administration of parecoxib combined with paracetamol to reduce postoperative acute and subacute breast surgical pain.

Patients with breast cancer undergoing mastectomy experience moderate postoperative pain which may persist for more than 3 months and may turn into chronic pain. This may interfere with the daily life of the patients. Proper prophylaxis and management to control postoperative pain are essential. Morphine is the most common drug to control postoperative pain. However, there are many serious side effects, e.g., nausea/vomiting, pruritus, ileus, constipation, sedation, and respiratory depression. Multimodal analgesia comprises the use of a combination of drugs to provide the opioid-sparing effect. Parecoxib, a selective cox-2 inhibitor, and intravenous paracetamol are reported to provide good postoperative analgesia. The investigators aim to apply a combination of parecoxib and paracetamol perioperatively to reduce postoperative morphine consumption.

Eligibility Criteria:
Inclusion Criteria:

* Patients with breast cancer undergoing elective mastectomy
* ASA physical status 1-3

Exclusion Criteria:

* Allergy to parecoxib, paracetamol, or sulfonamide
* History of opioid use
* Pregnant
* Renal or hepatic disease
Comparative Trial of IV Lacosamide Versus Phenytoin for Seizure Management

The Investigator plans to perform a prospective, randomized, single blinded, study that will compare patients treated with IV lacosamide to those treated with Phenytoin in the Intensive Care Unit (ICU) setting. The investigator will also evaluate the rate of clinically evident and sub-clinical seizures, and to compare long-term outcomes between patients treated with lacosamide and those treated with Phenytoin.


Eligibility Criteria:
Inclusion Criteria:

* Traumatic Brain Injury (TBI) or Subarachnoid hemorrhage (SAH)
* Admitted to the hospital less than 48 hours prior to randomization
* Glasgow Coma Scale (GCS) score 3-8 (inclusive), or GCS motor score of five or less and abnormal CT scan showing intracranial pathology
* Hemodynamically stable
* Older than 18 years of age

Exclusion Criteria:

* No IV access
* Spinal cord injury
* History of or CT confirmation of previous brain injury, including brain tumor, stroke, or a spontaneous intracerebral hemorrhage
* Hemodynamically unstable
* Suspected anoxia
* Liver failure
* Younger than 18 years of age
* Pregnant
* Allergy to phenytoin or lacosamide
* Inability to obtain consent
Safety, Pharmacokinetic and Efficacy Study of a 10% Triple Virally Reduced Intravenous Immune Globulin Solution in Patients With Primary Immunodeficiency (Hypo- or Agammaglobulinemia)

The purpose of this study is to determine the pharmacokinetics, efficacy and safety of Immune Globulin Intravenous (Human), 10% TVR (Triple Virally Reduced) Solution in subjects with primary immunodeficiency (PID) manifesting as hypo- or agammaglobulinemia. Subjects are treated every 21 days and receive a total of 12 infusions: for the first 3 infusions subjects receive GAMMAGARD S/D to ensure a steady-state and to acquire data with a licensed product; for the remaining 9 infusions subjects receive IGIV, 10% TVR Solution.


Eligibility Criteria:
Inclusion Criteria:

Subjects will be eligible for study entry if they:

* are at least 18 years old
* have a form of primary immunodeficiency (PID) as described by Rosen et al, 1999 16 manifesting as agammaglobulinemia (X-linked) or hypogamma-globulinemia (common variable immunodeficiency), requiring immunoglobulin replacement therapy
* have had regular treatment for at least three months with either intravenous immunoglobulin preparations or immunoglobulin preparations for intramuscular use given subcutaneously
* have serum IgG levels greater than or equal to 5 g/L as determined by the local laboratory at screening
* if female of childbearing potential, agree to employ adequate birth control measures during the study
* have given written informed consent

Exclusion Criteria:

Subjects will not be eligible for study entry if they:

* had severe adverse reactions to treatment with immunoglobulin preparations during the last three treatments before inclusion into the study
* suffer from documented selective IgA deficiency with antibodies against IgA
* have an acute infection that requires intravenous antibiotic treatment (Last treatment day should be seven days before study entry.)
* are known to be infected with HIV, HCV, or HBV
* are at high risk of contracting blood-borne viral infections through parenteral drug abuse or life style
* suffer from congestive heart failure and receive on-demand treatment with furosemide
* show renal dysfunction defined as serum creatinine greater than or equal to 1.5 mg/dL at baseline visit
* received another investigational drug in the three weeks preceding study entry
* in case of females, are pregnant or nursing mothers
Bear Bile Pill as add-on the Treatment of MDD

This is a single-center, double blind, randomized, placebo-controlled, parallel group study of bear bile pill, as add-on therapy in MDD patients conducted in Shang Hai Mental Health Center. The purpose of this study is to determine the efficacy and safety of bear bile pill in reducing symptoms of depression in Major Depressive Disorder (MDD)patients with inadequate response to current antidepressant therapy. Following a screening period, subjects who meet the entry criteria will be randomized to treated with either placebo or 450mg bear bile pill three times daily for 8 weeks.


Eligibility Criteria:
Inclusion Criteria:

1. Meets the Diagnostic and Statistical Manual of Mental Disorder, Fifth Edition, Text Revision (DSM-V) criteria for Major Depressive Disorder (MDD); a single or recurrent episode without psychotic features ;Codes are as follows: F32.0、F32.1、F32.2、F33.0、F33.1 、F33.2.
2. Outpatients or inpatients.
3. Male or female subjects aged 18-65 years.
4. Patients have got standard treatment of SSRI/SNRI monotherapy for more than 4 weeks in current episode of depression before trial entry.
5. MADRS score greater than 20.
6. Women of childbearing potential must be willing to use acceptable methods of contraception throughout the study period and the following one month.
7. The patient the patient fully understand and signed the informed consent form

Exclusion Criteria:

1. Patient has survived a suicide attempt or has acute suicidal tendencies (MADRS Item 10 \> 4).
2. Comorbidity according to DSM-V, axis I except major depressive disorder.
3. Failed 3 or more adequate antidepressant courses in current episode of depression.
4. MADRS reduction ratio ≥25% within one week from the screening to the baseline Visit.
5. Depressive episode secondary to psychiatric illness or somatic disease.
6. Serious and instable body disease such as cerebrovascular disease, liver and kidney disease, disease of internal secretion (abnormal thyroid function), blood disease; any history of seizures or other organic brain diseases.
7. History of alcohol or drug abuse over the last 6 months
8. Allergic history to bear bile pills, or serious drug allergic history.
9. Pregnant or lactating women and women of childbearing potential throughout the study period; men who have the desire of fertility within six months;
10. Clinically significant changes in ECG or laboratory tests, including \>1.5X upper limit of normal liver function、over the limit of normal renal function and blood sugar、abnormal cardiac troponins、obvious abnormity in the thyroid function
11. Treatment with MECT or rTMS in nearly three months.
12. Treatment with a systematic psychological treatment in nearly three months.
An Observational Study of Methoxy Polyethylene Glycol-Epoetin Beta (Mircera) in Stage V Chronic Kidney Disease Participants on Hemodialysis

This observational study will evaluate the efficacy and use of Methoxy polyethylene glycol-epoetin beta (Mircera) in participants with Stage V chronic kidney disease on hemodialysis receiving an erythropoietin prior to study entry. Attending physicians should have made the decision of placing the participant on methoxy polyethylene glycol epoetin beta in advance and not related to the study. The therapy will be administered by the attendant treating physician according to specifications in the package insert guidelines and to the routine of the site.


Eligibility Criteria:
Inclusion Criteria:

* Participants with chronic renal anemia with Stage V chronic kidney disease on hemodialysis and with a hemoglobin level of 10.0 - 13.0 grams per deciliter (g/dL)
* Participants had to be receiving an ESA prior to entering the study
* Female participants of childbearing age had to be using effective contraceptive methods

Exclusion Criteria:

* As per approved package insert
* Any contraindication to ESA treatment