cyrilzakka/clinical-trials huggingface dataset:
Long-term Atazanavir Experience in a High HIV Caseload Primary Care Practice in Sydney, Australia

This observational study will aim to determine long-term atazanavir experience in a high HIV caseload primary care practice in Sydney, Australia.

This observational study will aim to determine long term atazanavir experience in HIV-1 infected patients in a primary care setting.

3. OBJECTIVES OF THE STUDY i. Primary objective Long-term (2 years or greater) atazanavir experience in HIV-1 infected patients in a primary care setting through retrospective data collection.

ii. Secondary objectives

1. To illustrate long term therapeutic efficacy of atazanavir in ART naïve and experienced HIV-1 infected patients.
2. To illustrate long term tolerability to atazanavir in ART naïve and experienced HIV-1 infected patients.
3. To identify ART treatment history in ART naïve and experienced HIV-1 infected patients on ATV.
4. To identify contraindicated therapy in ART naïve and experienced HIV-1 infected patients on ATV.

Eligibility Criteria:
Inclusion Criteria:

1. HIV-1 positive
2. Have commenced ATV between 2002-2008 (Baseline)
3. Follow-up data (clinical and laboratory) available from baseline

Exclusion Criteria:

1. Patients not commenced ATV between 2002-2008
2. No follow-up data (clinical and laboratory) available from baseline
3. Patient 'lost to follow-up' with \< 2 years of follow-up data (Clinical and laboratory)
Manual Therapy in Hemophilic Arthropathy of the Ankle

Introduction: Haemophilic ankle arthropathy manifests as functional (deficit in muscle strength, mobility and proprioception), intra-articular degenerative alterations and chronic pain. Manual therapy techniques are characterised by treating the soft tissues with the aim of modifying their density, relieving pain, reducing tissue sensitivity and improving the ranges of mobility. The objective is to evaluate the safety and effectiveness of a manual therapy protocol in patients with haemophilic ankle arthropathy.

Methods: Randomised crossover clinical trial. 13 patients with haemophilic ankle arthropathy from different regions of Spain will be recruited and randomised into two study groups (experimental and control). Each session of the experimental group will last 50 minutes, with 1 physiotherapy session per week for a period of 3 weeks. Patients will be evaluated at the beginning of the study, after the intervention and after a follow-up period of 4 weeks. The treatment programme includes 10 techniques that must be administered bilaterally. The study variables are the frequency of ankle haemarthrosis, range of movement, pressure pain threshold, pain intensity, joint status, biomechanical analysis of gait and balance, functionality and kinesiophobia.

Expected results: To evaluate the safety of manual therapy in patients with haemophilia. To observe changes in pain, mobility, joint condition, stability and functionality of the ankle, and kinesiophobia.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with haemophilia A and B
* With severe haemophilia phenotype (\<1% FVIII/FIX)
* Over 18 years of age
* With a medical diagnosis of ankle arthropathy and with clinical assessment using the Hemophilia Joint Health Score
* On prophylactic or on-demand treatment with coagulation factor VIII/FIX concentrates

Exclusion Criteria:

* Patients with neurological or cognitive disorders that prevent them from understanding the questionnaires and physical tests
* Failure to sign the informed consent document
Study of Changes in Retrofoveolar Choroidal Thickness During Aerobic Exercise

Study the change of retrofoveolar choroidal thickness measured by optical coherence tomography during aerobic exercise inducing an increase in systolic blood pressure in healthy subjects.Ten healthy participants will perform an exercise (riding a bicycle ergometer) and will be examined with EDI-OCT. Each participant will be scanned before exercise, during the exercise and afterwards at 0 and 5 min. Each OCT measurement will be coupled to the arterial blood pressure evaluation.

Currently there is a growing interest in the study of the choroid in the pathogenesis of many ocular pathologies such as central serous chorioretinitis1, age-related macular degeneration, diabetic retinopathy, and myopia. Moreover, the recent development of new imaging methods allows the exploration of the normal and pathological processes of the choroid. In particular, the Enhanced Depth Imaging (EDI) mode in Optical Coherence Tomography (OCT) provides cross-sectional imaging of the choroid and in vivo measurement of its thickness. Understanding the factors that would modify the choroidal thickness would make it possible to better understand the pathophysiology of many chorioretinal pathologies and would help to guide therapeutics in the future.

However, systemic changes induced by physical activity, and in particular changes in systolic blood pressure, could be responsible for changes in the choroidal blood flow and thus in the choroidal thickness. The study consists in testing ten patients who will perform an exercise testing as part of the practice of a sportive activity. Patients will undergo an OCT in EDI mode to measure the retrofoveolar choroidal thickness during the exercise.

Each OCT image will be coupled to the evaluation of blood pression and heart rate.

Patients are treated in the usual way but the study is an interventional study, with minimal risks and constraints, because of the imaging (OCT image in EDI mode).

Eligibility Criteria:
Inclusion Criteria:

* Male patients wishing to perform a standardized aerobic exercise stress test Best - Corrected visual acuity ≥ 10/10 (Monoyer scale)
* Absence of ocular pathologies
* Absence of previous ocular surgery
* Refraction between -4 diopters and +4 diopters
* Absence of alcohol or drug abuse
* Absence of systemic pathologies
* Absence of regular doping ;

Exclusion Criteria :

* History of ocular pathologies, intraocular surgery
* Macular or papillary abnormality seen at OCT
* History of systemic pathology such as high blood pressure, diabetes
* Exercise \<72 hours
* Intake of coffee or tea \<48 hours
* High myopia (axial length\> 26mm) or high hyperopia (axial length \<19mm) -
* Professional athlete ;Sedentary patient doing sports less than twice a month ; smocking \<24 hours
* Pharmacological pupillary dilation \<72 hours
IMARA, Adapting SiHLE for Detained African American Adolescent Females

The IMARA Program will test the efficacy of a multi-session HIV Prevention program, adapted from an existing program(SiHLE), for incarcerated African American adolescent females.

African American adolescent females in youth detention centers are at high risk for HIV infection. There are, however, no evidence-based interventions (EBI) for this vulnerable population. The aim of this project is to develop and test a culturally and gender-appropriate sexual health education program designed to promote HIV preventive sexual behaviors among African American adolescent females in youth detention centers. The study will be conducted in four stages: (1) adaptation of SiHLE intervention; (2) pilot adapted intervention; (3) revisions to adapted intervention, measures, and implementation; and (4) implementation and evaluation.

We will work closely with the Metro Regional Youth Detention Center (RYDC), in Atlanta, Georgia for all four stages of the project. The first stage, adaptation of SiHLE intervention, will be implemented using data collected from a prior study and with use of Community and Teen Advisory Boards (CAB and TAB). The pilot intervention will be completed with 20 participants from Metro RYDC and will test recruitment and retention strategies, the adapted intervention, and all measures. Revisions will be made based on findings from the pilot. For stage four, implementation and evaluation, we propose to recruit 350 unmarried African American adolescent females, 13-17 years of age, from Metro RYDC. While at the Metro RYDC, adolescents will be invited to participate in the proposed study. All adolescents will be required to have verbal informed parental/guardian consent and complete signed assent forms. Adolescents who are eligible and willing to participate in the project will complete an initial survey conducted on a computer(ACASI). The survey is designed to assess adolescents' sexual risk and preventive behaviors. After they complete the survey, adolescents will then be assigned, by chance alone, to receive either the adapted SiHLE intervention or the control condition. All adolescents will complete 3 individual sessions implemented by an African American health educator.

As we anticipate the participants will be released prior to the follow-up assessment, adolescents will come to a central community site to complete follow-up interviews at 3 and 6-months after completing their initial survey. We will also obtain a self-collected vaginal swab specimen to test for chlamydia and gonorrhea. We will compare the new adapted SiHLE intervention, IMARA, to the control condition in its ability to maintain or enhance adolescents' use of HIV prevention behaviors. If successful, the findings could have important implications for HIV prevention in this vulnerable population.

Eligibility Criteria:
Inclusion Criteria:

* Female
* African American
* Ages 13-17
* Sexually experienced
* Incarcerated at least 2 days and released to a non-restrictive setting
* Parent/guardian consent
* Assent

Exclusion Criteria:

* Married
* Pregnant
Association Between Renal and Right Cardiac Functions After Urinary Sodium Depletion Following Cardiac Surgery

Following cardiac surgery, right ventricular function may be altered leading to increase central venous pressure and decrease in renal blood flow. The investigator's standard care includes use of diuretic to avoid interstitial fluid accumulation. The aim of the study is to assess cardiac and renal function before and after depletion by using diuretics

The study will compare cardiac and renal data before and 6 hours after use of diuretic

* Echocardiographic measure of right function (S wave, TAPSE, ventricle surfaces, inferior vena cava diameter) and left function (LVEF, cardiac output
* Renal function: cumulative diuresis, creatinine level variation and incidence of acute kidney injury using KDIGO classification (creatinine level\>26.5 or diuresis\<0.05 ml kg-1 h-1)

Eligibility Criteria:
Inclusion Criteria:

patient undergoing elective cardiac surgery under cardiopulmonary bypass

Exclusion Criteria:

* heart transplantation
* use of vasopressor
* chronic renal disease (DGF under 30 ml min-1)
* endocarditis
* patient under ECLS or CPIA
* patient under 18-year-old
Study to Evaluate the Safety and Efficacy of ARI0002h, for the Initial Treatment of Patients With Primary Plasma Cell Leukaemia

Phase II, pilot, open-label, prospective, multicenter, non-randomized study to evaluate the safety and efficacy of ARI0002h (cesnicabtagene autoleucel) in 20 patients with newly diagnosed primary plasma cell leukemia (PCL).

The study population is patients between 18 and 75 years of age with newly diagnosed primary plasma cell leukemia (pPCL), with a life expectancy of more than 3 months.

The primary objective is to assess the safety and efficacy of CARTBCMA ARI0002h (cesnicabtagene autoleucel) after initial treatment to induce response in patients with newly diagnosed primary plasma cell leukaemia.


Eligibility Criteria:
Inclusion Criteria:

1. Patients between 18 and 75 years old diagnosed with newly diagnosed primary plasma cell leukemia (the presence of 5% or more circulating plasma cells in peripheral blood smears in patients otherwise diagnosed with symptomatic multiple myeloma), according to International Myeloma Working Group (IMWG).
2. Disease measurable at diagnosis by monoclonal component in serum or urine, or by free light chains in serum according to the eligibility criteria for clinical trials of the "International Myeloma Working Group".
3. ECOG Performance Status from 0 to 2
4. Life expectancy greater than 3 months.
5. Adequate venous access and absence of contraindications for lymphoapheresis.
6. Patients who, after being informed, give their consent by signing the Informed Consent Document.
7. Up to two cycles of previous treatment for symptomatic control will be allowed before inclusion.

Exclusion Criteria:

1. No previous treatments, except for induction therapy for primary plasma cell leukemia.
2. Administration of any anti-BCMA therapy as part of induction
3. Not having achieved at least a minimal response with induction treatment (IMWG criteria)
4. Absolute lymphocyte count \<0.1x109/L
5. Active immunosuppressive therapy except for prednisone 10 mg/day (or equivalent).
6. Any other concomitant neoplasia, unless it has been in complete remission for 3 years or longer, except for non-melanoma skin cancer or completely resected in situ carcinoma.
7. Active infection requiring treatment.
8. Active HIV, HBV, or HCV infection.
9. Uncontrolled medical illness
10. Severe organ impairment that meets any of the following criteria: EF\<40%, DLCO \<40%, GFR \<30 ml/min, bilirubin \>3 times the upper limit of normality (unless due to Gilbert syndrome)
11. Previous diagnosis of symptomatic AL amyloidosis,
12. Pregnant or lactating women. Women of childbearing potential must have a negative pregnancy test at the screening phase.
13. Women of childbearing potential, including those whose last menstrual cycle was in the year prior to screening, who are unable or unwilling to use highly effective contraceptive methods\* from the beginning of the study to completion of the study.
14. Men who are unable or unwilling to use highly effective contraceptive methods\* from the beginning of the study to completion of the study.
15. Contraindication to receive lymphodepletive chemotherapy.
Genoss DES in Patients With a High Risk of Ischemic Events (GENTLE Registry)

This is a prospective cohort study to evaluate the long-term effect and safety of Genoss drug-eluting stents (DES) in patients with coronary artery disease with high ischemic features.

It is known that ischemic events after percutaneous coronary intervention (PCI) or coronary artery bypass surgery (CABG) increase as the anatomical, physiological, or functional complexity of coronary artery disease increases. Recently, the concept of complex higher-risk and clinically indented procedure (CHIP) has been proposed, which includes patients with various medical conditions, patients with various heart conditions, and patients with technically complex PCI. Until now, Genoss stents have no data on the evaluation of stents in patients with coronary artery disease and high ischemic features.

Eligibility Criteria:
Inclusion Criteria:

* Subject is ≥ 19 years
* Subject has signed informed consent for data release

Exclusion Criteria:

* Subject did not sign informed consent for data release
* Known intolerance to aspirin, clopidogrel, ticlopidine, heparin or any other anticoagulation / antiplatelet therapy required for PCI, cobalt chromium, Sirolimus or contrast media
* Pregnancy
* Subject with life expectancy less than 12 months
* Subject with cardiogenic shock
Chamomile Therapy for Generalized Anxiety

This study will determine the effectiveness of chamomile extract for treating generalized anxiety disorder.

Study hypotheses: 1)Chamomile extract will have a superior anti-anxiety effect compared to placebo. 2)Chamomile will have a comparable safety profile to that of placebo.

We propose to investigate the anti-anxiety activity of Chamomile. Among the many uses of Chamomile, its use as an anti-anxiety herb is universal. Despite its widespread use and acceptance, there have been no studies evaluating the safety and anti-anxiety efficacy of Chamomile in human subjects. Given this lack of controlled clinical data, we propose a pilot study of Chamomile safety and efficacy in mild anxiety, and propose using the data as a basis for statistically powering a future R01 application. We will ask: Is Chamomile a safe and effective alternative treatment for Generalized Anxiety Disorder (GAD)? To do this, 60 patients with a diagnosis of mild to moderate GAD will receive double-blind treatment for 8 weeks with either (i) Chamomile extract, or (ii) placebo. We hypothesize that Chamomile will have a superior anti-anxiety efficacy compared to placebo, and a comparable safety profile to placebo.

Eligibility Criteria:
Inclusion Criteria:

Men and women \> 18 years of age (all races and ethnicity)

Meet DSM IV criteria for GAD

Mild to moderate symptom severity

HAM-A score \> 8

Not receiving anti-anxiety medication (e.g., benzodiazepine, venlafaxine, buspirone, or SSRI)

Able to understand and provide signed informed consent

Able to participate in a 8-week study

Exclusion Criteria:

Patients \< 18 years old

Current DSM IV Axis I diagnosis of Major Depressive Disorder, Bipolar Disorder, Panic Disorder (with or without agoraphobia), Specific Phobia Disorder, Obsessive-Compulsive Disorder, Posttraumatic Stress Disorder, Acute Stress Disorder, Substance-Induced Anxiety Disorder, Schizophrenia, Other psychotic disorders, Current alcohol or drug abuse, Alcohol or drug dependence within 3 months, \[NB: Patients with co-morbid DSM IV Axis I Depressive Disorders NOS (e.g., minor depressive disorder, premenstrual dysphoric disorder, and recurrent brief depressive disorder will not be excluded)\]

Unstable medical condition (e.g., hypothyroidism, hypertension, myocardial infarction within 1 month, neoplastic condition)

Allergy to Chamomile preparation

Allergy to plants of the asteraceae family (e.g., ragweed, asters, chrysanthemum)

Allergy to mugwort, RAST, or birch tree pollen

Concurrent tranquilizer, antidepressant or mood stabilizer therapy

Concurrent use of over-the-counter anti-anxiety and/or antidepressant preparations (e.g., Chamomile, St. John's Wort, Kava kava)

Women of child-bearing potential not willing to employ a medically proven form of contraception (e.g., condoms, oral contraceptives, etc)
The Use of Klorsept Solution for Debriding Infected Wounds: is it Effective and Safe? Prospective Observational Study

Klorsept is a debridement solution of necrotic infected tissue promoting wound healing. The aim of this study is to elaborate the effectiveness and safety of this solution.

Klorsept is a debridement solution of necrotic infected tissue promoting wound healing. The aim of this study is to elaborate the effectiveness and safety of this solution.

This study will include 50 patients suffering from necrotic and infected wounds. Several parameters will be evaluated in order to provide the effectiveness and safety of this treatment.

Eligibility Criteria:
Inclusion Criteria:

* hospitalized patients with infected wounds who can sign an informed consent

Exclusion Criteria:

* patient that can not sign an informed consent
* pregnant woman
* age less than 18 years
* Allergy to chlorine
How Accurately Does the Diopsys Visual Evoked Potential (VEP) Vision Testing System Detect Glaucoma?

Evaluate sensitivity and specificity of NOVA-DN visually evoked potentials (VEP) protocol and new software method (Corda) for glaucoma detection using optical coherence tomography (OCT) images to differentiate between normal subjects and glaucoma suspects.

The aim of this study was to evaluate the ability of NOVA-DN VEP protocol and Corda parameters to discriminate between healthy eyes and eyes with early to moderate glaucomatous visual field loss. We will evaluate measurements of the NOVA-DN VEP protocol, Corda software and Cirrus spectral domain (SD) OCT software in order to compare and correlate.

Hypotheses is that NOVA-DN VEP protocol and Corda analysis results in a high sensitivity, specificity and area under the Receiver Operating Characteristic (ROC) curves (ROC area) for glaucoma detection. Second hypothesis is NOVA-DN VEP protocol and Corda parameters can differentiate between normal and glaucoma suspects.

Eligibility Criteria:
Inclusion Criteria:

Group 1: Healthy Subjects

* intraocular pressure less than 22 millimeters of mercury (mmHg)
* normal appearing optic discs and retinal nerve fiber layer (RNFL)
* normal optical coherence tomography (OCT) RNFL thickness
* normal visual field (VF) results in both eyes.

Group 2: Glaucoma Suspects

* glaucomatous appearance of optic discs and/or RNFL in at least one eye
* normal OCT
* normal VF results in both eyes.

Group3: Glaucoma Patients

* Glaucomatous optic disc appearance (cup to disc ratio, rim thinning or RNFL defects)
* Repeatable intraocular pressure (IOP) of 23 mmHg or more, in at least one eye
* Repeatable abnormal VF tests

Exclusion Criteria:

* inability to perform reliable VF or OCT
* visual acuity worse than 20/40
* refractive error greater than +/-5.00 diopters sphere, greater than +/- 3.00 diopers cylinder
Medical Assistant Health Coaching for Diabetes in Diverse Primary Care Settings

This study is a cluster (clinic level) randomized pragmatic trial to compare the effectiveness of MA Health Coaching (MAC) delivered by non-clinician primary care staff (i.e., MAs) versus usual care (UC) in improving diabetes clinical control among individuals with poorly controlled type 2 diabetes mellitus (T2DM).

The study will be conducted in the primary care environments of two distinct, yet representative healthcare systems in San Diego County: Neighborhood Healthcare (a San Diego County FQHC system and designated Patient-Centered Medical Home, serving predominantly ethnic minority, low income patients) and Scripps (a large, non-profit, private insurance-based health system, serving predominantly Caucasian, middle-to-higher income patients). Six hundred patients at intervention (n=2; patient N=300) and control (n=2; patient N=300) clinics, aged 18 and older, with T2DM, and glycosylated hemoglobin (HbA1c) ≥ 8.0%, and/or low-density lipoprotein cholesterol (LDL-C) ≥ 100 mg/dL, and/or systolic blood pressure (SBP) ≥ 140 within the last 60 days, will be identified and enrolled using electronic health records (EHRs). Primary clinical outcomes of HbA1c, LDL-C, and SBP assessed as part of quarterly (or annual, for LDL-C), standard-of-care medical visits will be extracted from EHRs over 12 months. Changes in patient-reported behavioral (diabetes self-care) and psychosocial (quality of life, patient activation) outcomes will be evaluated via telephone assessment in a subset of intervention and control (N=300 total) participants at baseline, month 6, and month 12. A thorough process evaluation will be conducted to establish reach, acceptability/feasibility, adoption/maintenance, and fidelity of the intervention and will integrate patient, MA, and primary care provider perspectives. Cost-effectiveness will also be examined from the health system perspective. Principles of community engaged research were incorporated in intervention and study planning and will be sustained throughout the research period.

Eligibility Criteria:
Inclusion Criteria:

1. Must be a patient at selected Scripps or Neighborhood Healthcare clinic,
2. Must be age 18 years or older,
3. Must have a T2DM diagnosis,
4. Must show evidence of poor clinical control, defined as HbA1c ≥ 8% and/or LDL-C ≥ 100 mg/dL, and/or SBP ≥ 140 mmHg.

Exclusion Criteria:

None as this is a pragmatic trial.