cyrilzakka/clinical-trials huggingface dataset:
Intravitreal AAVCAGsCD59 for Advanced Dry Age-related Macular Degeneration (AMD) With Geographic Atrophy (GA)

Patients with advanced dry AMD with GA meeting inclusion criteria will be randomized in one eye in a 1:1:1 ratio comparing intravitreal high or low dose AAVCAGsCD59 with a sham injection. All enrolled subjects will be followed for 24 months to evaluate reduction in GA growth and safety of intravitreal AAVCAGsCD59.


Eligibility Criteria:
Inclusion Criteria:

1. Advanced dry AMD with GA in the study eye
2. BCVA in the study eye of 80 or less ETDRS letters (Snellen equivalent 20/25 or worse)
3. Total cumulative GA lesion size 2.5 mm2 to 12.5 mm2 in the study eye as confirmed by the reading center during the Screening Period.

Exclusion Criteria:

1. GA secondary to non-AMD etiologies in the study eye (i.e. myopia, inherited retinal diseases).
2. GA associated with the presence of an RPE rip.
3. GA contiguous with peripapillary atrophy.
4. Active CNV secondary to wet AMD in the study eye and currently receiving anti-VEGF ocular treatment within the previous 18 months.
5. Subretinal fibrosis in the macula from CNV both clinically and imaged on SD-OCT in the macula.
6. Previous macular laser photocoagulation (i.e. focal or grid laser for macular edema), photodynamic therapy (PDT), ocular/orbital radiation, laser to CNV, or subretinal surgery for CNV in the study eye.
7. History of conditions in the study eye which might alter visual acuity or interfere with study testing including proliferative diabetic retinopathy (PDR), clinically significant macular edema (CSME), central retinal vein occlusion (CRVO), hemi retinal vein occlusion (HRVO), macular branch retinal vein occlusion, and optic neuropathy.
8. Active uncontrolled glaucoma with at least one of the following: IOP\>30 mmHg despite maximum medical treatment with glaucoma medications, cup-to-disc ratio of \>0.9, visual field defects secondary to glaucoma that involve the macula, or optic atrophy from glaucoma.
9. Active acute or chronic infectious uveitis, retinitis, or conjunctivitis (excluding blepharitis)
Virological Suppression in HIV Positive Patients Involved in a Novel Standardized Adherence Protocol

This study will look at virologically suppression of patients with HIV who receive pharmacist or case management care.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a baseline viral load \> 200 copies/ml
* Patients who agree to program enrollment
* Patients ≥ 18 years of age

Exclusion Criteria:

* Pregnant women
* Adults unable to consent
* Prisoners
Supported Employment Demonstration

The purpose of this study is to determine whether offering an evidence-based package of employment supports integrated with mental health services has a positive impact on employment and clinical recovery, and delays or diminishes the need for disability benefits.

SSA contracted with Westat to implement and evaluate the Supported Employment Demonstration (SED). The SED provides integrated mental health and vocational services to people with mental illness who were recently denied Social Security disability benefits. The evaluation will determine the impact of the SED on employment, clinical recovery, and receipt of disability payments. The evaluation is using a randomized controlled trial design to compare the outcomes of two treatment groups and a control group. In the full-service arm (n = 1,000), participants receive services from an Individual Placement and Support employment specialist, a care manager, and a nurse care coordinator (NCC) who provides medication management support, as well as modest funding for out-of-pocket prescriptions, essential work-related expenses, and other services in the participant's treatment plan. The basic-service arm (n=1,000), which is expected to cost about 50 percent less than the full-service arm, provides all services and funds except the NCC. Participants in the usual services (control) group (n = 1,000) seek services as they normally would but receive a comprehensive guide to local, state, and national resources.

Data collection includes computer-assisted baseline (in-person) and blinded quarterly (telephone) interviews with participants, collection of SSA administrative and site-level program data, site visits (including fidelity assessments), qualitative interviews with site administrators and service providers, focus groups with study participants, and person-centered ethnographic interviews with participants and nonparticipants.

Eligibility Criteria:
Inclusion Criteria:

* Individuals denied Social Security disability benefits (SSDI or SSI)
* Individuals alleging a mental impairment
* Live in Community Mental Health Agency (CMHA) catchment area
* Legally competent
* Express desire to improve work situation

Exclusion Criteria:

* Intellectual disability
* Reside in a nursing home or custodial institution
* Already receiving supported employment services from CMHA site
A Phase 2 Study With MIP-1404 in Men With High-Risk PC Scheduled for RP and EPLND Compared to Histopathology

This was a multicenter, multi-reader, open-label, Phase 2 study assessing the safety and performance characteristics of MIP 1404 imaging in the detection of prostate gland and pelvic lymph node cancer. Comparative performance characteristics between MIP 1404 imaging and MRI were also assessed, as judged by histopathology results.

This is a single arm, open label study of approximately 100 high-risk prostate cancer patients scheduled for prostatectomy and extended pelvic lymph node dissection. Patients receive a single IV dose of 99mTc-MIP-1404 (study drug) followed by SPECT/CT scan 3-6 hours after injection. As standard of care, patients will undergo prostatectomy and extended pelvic lymph node dissection (EPLND) within three weeks of study drug dosing. 99mTc-MIP-1404 image data will be evaluated for visible uptake and compared with histopathology.

Eligibility Criteria:
Inclusion Criteria:

* Male aged 21 years or older.
* Ability to provide signed informed consent and willingness to comply with protocol requirements.
* Biopsy confirmed presence of adenocarcinoma of the prostate gland.
* At high-risk for metastatic disease by a stage of cT3, cT4, or a total nomogram score of greater than or equal to 130.
* Scheduled to undergo radical prostatectomy with extended pelvic lymph node dissection.
* Agree to use an acceptable form of birth control for a period of 7 days after the 99mTc MIP-1404 injection.

Exclusion Criteria:

* Participating would significantly delay the scheduled standard of care therapy.
* Administered a radioisotope within 5 physical half lives prior to study drug injection.
* Have any medical condition or other circumstances that, in the opinion of the investigator, would significantly decrease obtaining reliable data, achieving study objectives or completing the study.
* Have a contraindication for MR imaging.
Examining the Effect of Nutritional Supplementation on Skeletal Muscle Mass in Patients Awaiting Lung Transplant

This non-randomized pilot study aims to investigate whether a protein rich nutritional shake (Ensure Enlive) given to patients pre-transplant will decrease skeletal muscle loss (measured by quadriceps ultrasound) and improve nutritional state (measured by Nutritional Risk Index). A nutritional supplement would be a cost-effective solution to treat malnutrition, a known risk factor implicated in poor outcomes for lung transplant recipients.


Eligibility Criteria:
Inclusion Criteria:

* Subjects 18 years or older who are listed for single or double lung transplant
* Subject provides written informed consent to participate in this study

Exclusion Criteria:

* Subject with history of Galactosemia
* Subject with history of milk protein allergy
* Subject with history of soy protein allergy
Prophylactic Ivermectin in COVID-19 Contacts

asymptomatic family close contact of confirmed COVID -19 patient will receive prophylactic ivermectin and will be followed up for 14 days for any symptoms \& diagnosis of COVID -19


Eligibility Criteria:
Inclusion Criteria:

family contact of confirmed COVID-19 case

Exclusion Criteria:

* refuse to participate and receive the drug pregnancy or lactation known hypersensitivity to ivermectin
Immunotherapy and Irreversible Electroporation in the Treatment of Advanced Pancreatic Adenocarcinoma

Compare the efficacy and tolerability of irreversible electroporation in combination with Nivolumab in patients with locally advanced pancreatic cancer.

Immunotherapy and irreversible electroporation in the treatment of advanced pancreatic adenocarcinoma. This is a Phase II study in which all patients undergoing irreversible electroporation of locally advanced pancreatic adenocarcinoma will be treated with nivolumab post-operatively.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years if age
* Diagnosed with stage III pancreatic cancer
* Tumor is measurable
* Glomerular Filtration Rate \> 60 m/L/min/1.73 m(2)
* Willing and able to comply with the protocol requirements
* Able to comprehend and have signed the informed consent to participate

Exclusion Criteria:

* Participating in another clinical trial for the treatment of cancer at time of screening
* Are pregnant or currently breast feeding
* Have a cardiac pacemaker or Implantable Cardioverter Defibrillator implanted that cannot be deactivated during the procedure
* Have non-removable implants with metal parts within 1 cm of the target lesion
* Had a myocardial infarction within 3 months prior to enrollment
Trial of Mental Health Treatment for Darfur Refugees in Cairo

The enormous global burden of mental illness has been estimated through the publication of the Global Burden of Disease Study, adding momentum to refugee mental health studies (1,2). As research confirms that high levels of Posttraumatic Stress Disorder (PTSD) and depression occur in post-conflict settings, it is essential to develop effective treatment for psychological trauma in refugee populations recovering from mass violence (3-4). PTSD and depression are risk factors for anger, interpersonal discord and violence, not only among those who have trauma and depression, but also among their spouses and children (5-9). This "infectious" model of trauma/violence is critically important in the setting of ethnic conflict, as increased levels of interpersonal violence within the afflicted community hinder its recovery and fuel future cycles of conflict. To date, there has been little research on the interpersonal effects of trauma among refugee populations. The proposed research is a pilot and randomized controlled trial of "Interpersonal Therapy" (IPT) for Sudanese refugees living in Cairo. IPT, a very effective therapy for depression, has been adapted for PTSD treatment and sub-Saharan Africa settings (10-12). Measures will evaluate success of the treatment not only in terms of individual PTSD and depression symptoms, but also with respect to interpersonal conflict. Hypotheses: (1) After IPT intervention, Sudanese refugees will have lower levels of depression and trauma symptoms compared to wait list controls (2) After IPT intervention, Sudanese refugees will have lower levels of interpersonal violence compared to wait list controls.


Eligibility Criteria:
Inclusion Criteria:

1. Age greater than 18 years;
2. Absence of cognitive dysfunction which requires a higher level of care and/or interferes with ability to participate in IPT;
3. Absence of severe thought or mood disorder symptoms which requires a higher level of care and/or interferes with ability to participate in IPT;
4. Absence of drug and alcohol dependence;
5. HTQ score of 2.3 or greater;
6. Ability to attend twice a week therapy sessions for 4 weeks and return for regular screening;
7. Ability to give verbal informed consent .

Exclusion Criteria:

1. Unable to give informed consent;
2. Age less than 18;
3. Cognitive dysfunction which requires a higher level of care and/or interferes with ability to participate in IPT;
4. Severe thought or mood disorder symptoms which requires a higher level of care and/or interferes with ability to participate in IPT;
5. Drug or alcohol dependence in the past 6 months;
6. HTQ score less than 2.5;
7. Inability to attend twice a week therapy sessions for 4 weeks and return for regular screening .
Implantable Cardiac Defibrillators for the Prevention of Sudden Death in Patients With Cardiac Sarcoidosis

The purpose of this study is to identify patients with cardiac sarcoidosis who may be at risk for sudden death.

Sarcoidosis is an inflammatory disease that can effect many organ systems. Patients with sarcoidosis involving the heart are at risk of sudden death related to ventricular arrythmias. However, we currently do not have a clinical test which can predict sudden cardiac death in these patients. While implantable cardioverter defibrillators(ICDs) can prevent sudden cardiac death in high risk patients, we do not know which patients will benefit from implantation of these devices. This clinical problem is important because we would like to identify patients at risk for sudden death who will benefit from ICD implantation. Additionally, we would like to avoid the risks to patients and financial expenses of inserting ICDs in patients who will not benefit from them.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Cardiac Sarcoidosis
* Previous Implantable Cardioverter Defibrillator (ICD)
A Web-based Approach to Treating Cardiovascular Disease Risk in Employees With Metabolic Syndrome

The purpose of BEHHS is first to assess the baseline sub-clinical disease in a population of Baptist Health Employees who have Metabolic Syndrome, a known contributor to cardiovascular disease. Second, the investigators wish to encourage a healthy lifestyle through personalized nutrition and fitness advice, delivered as part of a web based program, which will in turn lead to increases in heart healthy behaviors such as increased consumption of heart healthy foods, increased exercise initiation, and more positive attitudes about health. To assess this, the investigators plan to randomize 200 employees with Metabolic Syndrome to either the new web-based diet and lifestyle program, or to care-as-usual, which is the currently offered MyWellnessAdvantage and WebMD websites. The investigators hypothesize that the web-based group will show greater improvements in physical health (such as weight loss, cholesterol reduction, etc.) as well as increased consumption of heart healthy foods, exercise initiation, and quality of sleep as measured by surveys administered at the 4,8, and 12 month follow-up appointments.


Eligibility Criteria:
Inclusion Criteria:

* Employee of Baptist Health
* Access to Internet
* Has a smart phone (Android or Apple supported) with data plan
* Has an email address
* Diagnosis of three or more of the following:

  1. Waist circumference \>=40 inches in and male and \>= 35 inches in a female
  2. Fasting triglyceride level \> 150 mg/dl\*
  3. HDL-C \< 40 mg/dl in men or \< 50 mg/dl in women\*
  4. BP \> 130/85 mm Hg\*
  5. Fasting blood glucose \> 110 mg/dl

     * Or currently on medication to treat the abnormal condition

Exclusion Criteria:

1. Prior history of major cardiovascular events (angina, myocardial infarction, prior coronary revascularization
2. Any woman of childbearing potential who is pregnant, breastfeeding/currently lactating, seeking to become pregnant or suspects that she may be pregnant\*\*
3. Active treatment for cancer
4. Known history of a bilateral mastectomy
5. Known history of diabetes (already being treated as high-risk group, would not qualify as having Metabolic Syndrome for purposes of our study)
6. Known history of Chronic Obstructive Pulmonary Disease
7. Currently in atrial fibrillation
8. Known history of hypo-tension
9. Known history of heart failure
10. Known history of aortic valve stenosis
11. Known history of heart block
12. Chest CT scan in the last year
13. Cognitive inability as judged by the interviewer
Vaccine Therapy in Treating Patients With Stage III or Stage IV Ovarian Epithelial Cancer

RATIONALE: Vaccines made from tumor tissue may make the body build an immune response and kill tumor cells.

PURPOSE: Phase II trial to study the effectiveness of vaccine therapy in treating patients who have stage III or stage IV ovarian epithelial cancer.

OBJECTIVES: I. Determine whether patients with surgically debulked ovarian epithelial cancer develop delayed-type hypersensitivity to dinitrophenyl-modified autologous tumor vaccine. II. Assess the toxic effects of this regimen in these patients. III. Determine the feasibility of conducting a group wide vaccine study.

OUTLINE: Patients undergo a standard debulking procedure with the tumor tissue being sent to Thomas Jefferson University. Patients then receive six courses of combination chemotherapy consisting of either paclitaxel and cisplatin or paclitaxel and carboplatin. Vaccine therapy must commence within 4-12 weeks of completion of chemotherapy. Patients are tested for delayed-type hypersensitivity (DTH) on day -7. Cyclophosphamide IV is administered on day 0. Dinitrophenyl (DNP)-modified autologous ovarian epithelial cell vaccine and BCG adjuvant are injected once a week beginning on day 3 and continuing for 6 weeks. DTH testing is repeated at week 8. Booster vaccine injections are administered at 6 and 12 months if patient is disease free. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: Approximately 20 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Surgically debulked stage III or IV ovarian epithelial cancer Must be able to obtain adequate number of viable cells from excised tumor mass Must have received 6 courses of combination chemotherapy comprised of either paclitaxel and cisplatin OR paclitaxel and carboplatin Must be clinically tumor free following completion of chemotherapy (i.e., no metastasis by physical examination and CT of the abdomen and pelvis and serum CA-125 less than 35 IU/L) Not on a Phase III GOG protocol

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: GOG 0 or 1 Hematopoietic: Hematocrit at least 25% WBC at least 3,000/mm3 Hepatic: Not specified Renal: Not specified Other: Not pregnant or nursing No active infections HIV negative Hepatitis B surface antigen negative Hepatitis C antibody negative No active autoimmune disease No prior invasive malignancy within the past 5 years except nonmelanomatous skin cancer, carcinoma in situ of the cervix, or superficial bladder cancer

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics 4-12 weeks since prior chemotherapy Endocrine therapy: No concurrent systemic corticosteroids Radiotherapy: At least 6 months since prior major field radiotherapy Surgery: See Disease Characteristics
Effect of Obesity on Tear Film and Ocular Health Among Diabetic Patients

To evaluate the effect of obesity on tear film and ocular health in diabetic patients.

Research Design An observational cross-sectional study will be conducted.


Eligibility Criteria:
Inclusion Criteria:

* Adults (18+ years)
* diagnosed with type 1 or type 2 diabetes
* categorized as obese or non-obese (BMI \>30 or \<30)
* stable glycemic control, and willing to provide consent.

Exclusion Criteria:

* Non-diabetic individuals
* pregnant/lactating women
* those with recent ocular surgeries
* systemic medications affecting tear film, or severe unrelated diseases.
Role of Fibrocytes in the Bronchial Remodelling of Chronic Obstructive Pulmonary Disease

Airway remodelling is an abnormal tissue repair following bronchial inflammation, which contributes to none reversible pathological features, such as bronchial and peri-bronchial fibrosis. It also influences the prognosis of Chronic Obstructive Pulmonary Disease (COPD) and its mechanisms remain largely unknown. The role of fibrocytes has been demonstrated in the pathophysiology of asthma, lung fibrosis or pulmonary hypertension. However, the recruitment of blood fibrocytes and their involvement in COPD airway remodelling remain unknown.

The main objective of the study is to analyse the distribution and quantify the number of the peri-bronchial and blood circulating fibrocytes in patients with different stages of COPD compared to control subjects.


Eligibility Criteria:
Inclusion Criteria:

* Male or female aged more than 40 yr
* Patient needed a thoracic surgery such as lobectomy for cancer or lung transplantation or lung reduction volume surgery.
* COPD group: diagnostic of COPD and differentiation of the stage from 1 to 4 according to the GOLD guidelines.
* Control group: subjects with normal lung function testing and no chronic symptoms (cough or expectoration). Subjects will be separated in 2 groups according to smoking history (Never smokers, smokers (former or current) and paired to patients according to age and sex.
* with a written informed consent

Exclusion Criteria:

* Subject without any social security or health insurance
* Asthma, lung fibrosis or idiopathic pulmonary hypertension
* Chronic viral infections (hepatitis, HIV)
* Pregnant woman or breastfeeding
* Subject included for cancer surgery with a Pn0 diagnosis not confirmed after the intervention.
Inspiratory Muscle Training (EMI) on Inspiratory Muscle Strength, Pulmonary Capacity and Performance in Soccer Players

The training of the respiratory muscles seems to be fundamental in people who require a high physical demand. There is abundant scientific evidence that relates the respiratory variables and the limitation to exercise. The published studies are athletics and cycling, however it is scarce in football. Objective. To assess the effects of inspiratory muscle training on lung function and sports performance in soccer players.

Objective. To assess the effects of inspiratory muscle training (IMT) on lung function, inspiratory muscle strength and athletic performance in soccer players.

Method. Participants will be randomized into two groups: experimental and sham . The two groups will perform a protocol of 8 weeks of training (6 days / week) with the PowerBreathe device. The EG will use progressive resistance loads up to 80% of the MIP, while the SG will use the device with a minimum load (20% PImax) during the 8 weeks. All participants will have the following tests before and after the intervention and 3 months after the end of the program: spirometry (FVC, FEV1), PImax, biophotogrammetry, and fit 30/15 test. For the statistical analysis, a 2-factor variance analysis will be performed for repeated measures and Pearson's correlations. The statistical significance will be set with a value of p \<0.05. The effect size will be calculated using the partial eta-square.

Eligibility Criteria:
Inclusion Criteria:

* Soccer players

Exclusion Criteria:

* Soccer players with disabilities