cyrilzakka/clinical-trials huggingface dataset:
Academic Detailing to Optimize PrEP Implementation in Pediatric Primary Care Settings: ADOPT-PrEP

In this study, 50 pediatricians will participate in academic detailing, an evidence-based, 1-on-1 outreach education technique intended to promote clinician behavior change through brief, highly interactive, and individualized dialogues with trained educators, or "detailers". The goals of this study are to learn about whether this is a practical and acceptable technique, and whether it changes how pediatricians prescribe pre-exposure prophylaxis (PrEP) to adolescents and young adults (AYA) and how patients take it.

Adolescents and young adults (AYA) account for nearly 20% of new HIV diagnoses in the US. Only 10% of sexually active adolescents have ever been tested for HIV2 and very few have used pre-exposure prophylaxis (PrEP), despite it being safe, highly effective at preventing HIV transmission, and FDA-approved for youth. Pediatric health care providers (physicians and associate clinicians) could have a major impact on PrEP use for youth, as they are trusted sources of health information for AYA. However, pediatricians infrequently discuss or recommend PrEP due to limited training in sexual health and PrEP and a lack of tools and protocols to help them integrate PrEP into busy clinical workflows. Academic detailing, an evidence-based, 1-on-1 educational outreach technique for clinicians proven to change prescribing behaviors, could improve PrEP prescribing and persistence for AYA. Academic detailing has been associated with substantial increases in PrEP prescribing in adult settings but has not been tested in pediatric settings. The objective of this study is to develop an implementation strategy to improve PrEP provision to AYA at a large children's hospital and affiliated community health center in an HIV priority jurisdiction. Our hypothesis is that academic detailing for PrEP that has been adapted for a pediatric and young adult population will be feasible, acceptable, and result in rapid, sustained, and clinically significant improvements in PrEP provision in pediatric settings.

After conducting qualitative interviews with AYA and pediatric providers to explore barriers and facilitators and to them develop materials specific to this study, we will conduct a pilot study of academic detailing amongst 50 pediatric providers in the Boston area. Providers will be recruited from Boston-area practices and invited to participated in the pilot project. Providers will complete 2 academic detailing visits and a post-visit qualitative interview and survey to assess feasibility and acceptability. Secondary outcomes include preliminary impact of academic detailing on their knowledge, intentions and readiness to prescribe PrEP, and changes in PrEP prescriptions, persistence, and HIV testing after the intervention through electronic medical record review.

Eligibility Criteria:
Inclusion Criteria:

* Primary care provider at one of our 3 study sites (Boston Children's Hospital Adolescent/Young Adult Medicine, Martha Eliot Health Center, Children's Hospital Primary Care Center)

Exclusion Criteria:

* None
Treatment of the Overactive Bladder Syndrome: A Delphi Study

Idiopathic overactive bladder syndrome (iOAB) is a prevalent condition in urological practice. The variability in management between specialists and between centers remains high. Even guidelines are not always clear on the treatment management of drug therapy resistant OAB. Standardization in OAB treatment is needed.

Guidelines on the overactive bladder syndrome (European Association of Urology, American Urology Association and International Consultation on Incontinence) are comparable but remain vague mainly on the level between conservative and major surgery. They do not specify combinations of medications and do not distinguish between intradetrusor botulinum toxin injections (BTX) and sacral neuromodulation (SNM) because of lack of evidence.

To reduce the variability in the treatment management of OAB, standardization is needed.

By use of a Delphi technique, the current perception of Belgian urologists towards the most appropriate treatment approach for idiopathic OAB (iOAB) was explored.

Based on these results a practical treatment algorithm for its use in daily clinical practice could be developed.

Eligibility Criteria:
Inclusion Criteria:

* Profession: MD, Urologist
* Member of the working group of Functional Urology

Exclusion Criteria:

* Retirement
* Non-operative as an urologist.
DHEA Supplementation for Low Ovarian Response IVF Patients

Approximately 10% of all couples will be diagnosed as infertile. The most efficient infertility treatment is In-Vitro Fertilization (IVF). One major determinant for success is production of an adequate number of oocytes (eggs) from the female in order to finally have good-quality embryos and finally acceptable pregnancy and delivery rates. Some women will not respond adequately to hormonal stimulation and will only a small number of oocytes. Therefore, the chances of finally having a successful delivery are significantly reduced. Although the specific definition of this situation is controversial, these patients are diagnosed as having "low ovarian response". This condition is more prevalent in older IVF patients as part of the reproductive aging process; it is possible at any age. Currently, the understanding of "low ovarian response" is limited, and although many therapeutic approaches have been suggested, no treatment has been proven significantly efficient.

DHEA is a pro-hormone produced by the adrenal gland and the ovary. DHEA serum levels become lower with age and in some chronic diseases. Therefore, some believe it may be beneficial as an 'anti-aging' factor. DHEA pills are available as a food-supplement, without need for prescription in the US.

DHEA is involved in the regulation of follicular growth in the ovaries. In a 2000 report, five IVF patients who had low ovarian response were treated with oral DHEA (Casson et al, Hum Reprod 2000;15:2129). A small increase in the ovarian response to hormonal stimulation was noticed. Barad and Gleicher reported their relatively extensive experience, summarizing treatment outcome in 25 IVF low-responders treated with oral DHEA pills (Barad and Gleicher, Hum Reprod 2006; 21, 2845). They observed increased increases in fertilized oocytes, normal day 3 embryos, and number of embryos transferred after DHEA treatment compared with a previous treatment outcome before DHEA.

Based on this observation, DHEA may appear useful for improving IVF outcome in some patients. However, a prospective randomized study on DHEA supplementation for IVF patients was not yet published. Our aim is to conduct such a study, focusing on IVF patient with low ovarian response.


Eligibility Criteria:
Inclusion Criteria:

* IVF patient
* Low ovarian response to hormonal stimulation

Exclusion Criteria:

* Previous DHEA supplementation
* History of malignant disease
* Liver dysfunction
* Coagulation tendency
A Prospective Clinical Evaluation of the Total Vascular Access (TVA) FLEX-1 Device Protocol Flex-1-002-IR Intervention Reduction (IR)

The primary objective of this clinical study is to evaluate the preliminary safety and effectiveness of using the FLEX-1 device for the creation of an arteriovenous fistula (AVF) including coiling of the brachial vein during the index procedure in patients requiring chronic hemodialysis.


Eligibility Criteria:
Inclusion Criteria:

* Eligible for a native surgical arteriovenous fistula, as determined by the treating physician.
* Adult (age \>18 years old).
* Advanced chronic kidney disease (CKD), stage 4 or 5 electing for hemodialysis.
* Written informed consent obtained
Safety of SonoVue on Pulmonary Hemodynamics

This is an intra-subject crossover comparative safety study to evaluate the effect of intravenous (IV) bolus injection of SonoVue on pulmonary hemodynamics.

Subjects will be divided into two groups based on their baseline mean pulmonary arterial pressure. Each subject will receive two injections in randomized order during right heart catheterization: one administration of SonoVue and one administration of placebo, either SonoVue followed by Placebo or Placebo followed by SonoVue. The purpose is to provide direct evidence on the presence or absence of pulmonary hemodynamic effect following IV administration of SonoVue versus any effects following IV administration of the same volume of placebo.

Eligibility Criteria:
Inclusion Criteria:

* Provides written informed consent male or female at least 18 years of age scheduled to undergo right heart catheterization for clinical reasons

Exclusion Criteria:

* Pregnant or lactating females
* Significant arrhythmia or non-sinus rhythm that may affect the ability to assess pulmonary hemodynamics by catheterization
* Known allergy to one of the ingredients in the investigational product or to any other contrast agents including ultrasound contrast agents
* Previously entered into the study or received an investigational compound within 30 days before admission into the study
* Unstable pulmonary and/or systemic hemodynamic condition that would affect the ability to evaluate the pharmacological or hemodynamic effect of the investigational products
Study of Dasatinib in Patients With Advanced Solid Tumors

The purpose of Segment 1 of the study is to determine the effect of ketoconazole on dasatinib. The purpose of Segment 2 is to learn how dasatinib affects tumor growth in patients with advanced solid tumors.


Eligibility Criteria:
Inclusion Criteria:

* ECOG status 0-2
* Advanced or metastatic disease, unresponsive to standard treatment (or no standard treatment exists)
* Biopsy pretreatment
* Adequate bone marrow, liver and kidney function

Exclusion Criteria:

* Serious cardiovascular disease
* Bleeding disorders
* Gastrointestinal (GI) tract disease
* Platelet inhibitors
* H2 blockers, proton pump inhibitors
Physicians' Awareness of ECG Abnormalities Linked to Acute Ischemic Chest Pain

This study aims to investigate physicians' awareness regarding patients presenting with potential acute ischemic chest pain. It focuses on various electrocardiogram (ECG) patterns requiring prompt catheter lab activation for reperfusion therapy alongside other ECG mimics that may lead to false catheter lab activations.

Chest pain is the second most common complaint in adult emergency department (ED) patients in the United States. Most visits result in a diagnosis of noncardiac chest pain and approximately half in nonspecific chest pain. Roughly 6% are ultimately diagnosed with a life-threatening condition, which is overwhelmingly (\>90%) acute coronary syndrome (ACS).

The term acute coronary syndrome (ACS) is applied to patients in whom there is a suspicion or confirmation of acute myocardial ischemia or infarction. ST-elevation myocardial infarction (STEMI), Non-ST-elevation MI (NSTEMI), and unstable angina are the three traditional types of ACS.

Eligibility Criteria:
Inclusion Criteria:

* Age from 25 to 65 years.
* Both sexes.
* Physicians who treat patients with possible acute chest pain.

Exclusion Criteria:

- Participants who failed to complete the survey questions.
A Phase 1 Study of KBP-5209 in Patients With Advanced Solid Tumors

The purpose of this study is to determine the maximum tolerated dose of KBP-5209 as a single agent when given orally to adult patients with advanced solid tumors that have progressed despite standard therapy, or where there is no standard therapy.

This is a Phase 1, open-label, multicenter study of KBP-5209 administered orally once daily (QD) in 28-day treatment cycles to adult patients with advanced solid tumors which have progressed despite standard therapy or for which no standard therapy exists. This study is designed to determine the MTD or RP2D and to characterize the safety, tolerability, and PK profile of KBP-5209.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older;
* Patients with histologically or cytologically confirmed, advanced solid tumors which have progressed despite standard therapy or for whom no standard therapy exists.
* Patients must have at least one measurable or non-measurable lesion (dose escalation only) as defined by RECIST v1.1
* Eastern Cooperative Oncology Group performance score 0 to 2;

Exclusion Criteria:

* Patients with symptomatic CNS metastases;
* Patients who have a known history of hepatitis C or chronic active hepatitis B or a known diagnosis of HIV
* Any significant ophthalmologic abnormality
* Patients who have any severe and/or uncontrolled medical conditions
* Significant gastrointestinal abnormalities,
* Patients who have impaired cardiac function or clinically significant cardiac diseases,
* Chemotherapy, biologic therapy, immunotherapy, radiotherapy or investigational agents within 5 half-lives or within 4 weeks (whichever is longer) prior to administration of the first dose of study drug on Day 1 or have not recovered from the side effects of such therapy;
* Treatment with third generation EGFR inhibitors
* Major surgery/surgical therapy for any cause within 4 weeks of Screening;
Maitland Thoracic Mobilization Versus Mulligan Thoracic Mobilization in Kyphotic Patients With Shoulder Impingement Syndrome

In recent years the management of shoulder impingement syndrome (SIS) included the thoracic spine as it was proved that it's highly correlated to pathologies in shoulder joint. SIS is proved to be associated with kyphotic posture. Also, It was proved that changing sitting posture affects the measured ROM of shoulder joint and this implicates the influence of changing thoracic position on shoulder mechanics. Explanations were made regarding the role of thoracic spine in affecting the shoulder joint through two ways. Firstly, through affecting the mechanics of scapular movements and secondly through altering the length tension relationship of shoulder musculature. This study would aim at studying the most effective thoracic mobilization in the treatment of SIS.


Eligibility Criteria:
Inclusion Criteria:

* Shoulder impingement syndrome SIS clinically diagnosed by using Hawkins-Kennedy test, the painful arc test, and the infraspinatus muscle strength test; and for a rotator cuff tear, the infraspinatus and the drop-arm test and supraspinatus muscle strength tests.
* Subjects will be diagnosed of having postural kyphosis proved by a physician referral or modified Cobb's angle of more than 40 degrees (x-ray).

Exclusion Criteria:

* The participants with any musculoskeletal abnormalities eg. Glenohumeral instability.
* Neurological abnormalities.
* Surgical operation of the last 4 months will be excluded from the study.
* Shoulder corticosteroid injection at any time in the past.
* Engaging in any athletic physical activities.
Safety, Tolerability and Immunogenicity of Meningococcal B Recombinant Vaccine Administered With or Without Routine Infant Vaccinations to Healthy Infants According to Different Immunization Schedules

Primary :1.To demonstrate a sufficient immune response of rMenB+OMV NZ, when given concomitantly with routine infant vaccines to healthy infants at 2, 4 and 6 and 2, 3 and 4 months of age, as measured by percentage of subjects with serum bactericidal activity (SBA) titer ≥1:5, at 1 month after the third vaccination Secondary :To demonstrate that immunogenicity of routine infant vaccines, when given concomitantly with rMenB+OMV NZ to healthy infants at 2, 3 and 4 months of age, was non-inferior to that of routine infant vaccines given without rMenB+OMV NZ. 2. To demonstrate that the immunogenicity of rMenB+OMV NZ when given concomitantly with routine infant vaccines was non-inferior to that of rMenB+OMV NZ given without routine infant vaccines at 2, 4 and 6 months of age. 3. To assess prevalence of meningococcal B antibodies over the study period by evaluation of SBA, at baseline and at 1 month after third vaccination, in subjects- received routine infant vaccine without rMenB+OMV NZ.


Eligibility Criteria:
Inclusion Criteria:

* Healthy 2-month old infants (55-89 days, inclusive), who were born after full term pregnancy with an estimated gestational age ≥ 37 weeks and a birth weight ≥ 2.5 kg;
* For whom a parent/legal guardian has given written informed consent after the nature of the study has been explained.

Exclusion Criteria:

* History of any meningococcal B or C vaccine administration;
* prior vaccination with routine infant vaccines (Diphtheria, Tetanus, Pertussis, Polio, Haemophilus influenzae type b (Hib), and Pneumococcal antigens);
* Previous ascertained or suspected disease caused by N. meningitidis;
* History of severe allergic reaction after previous vaccinations or hypersensitivity to any vaccine component;
* Significant acute or chronic infection within the previous 7 days or axillary temperature major or equal to38 degrees within the previous day;
* Antibiotics within 6 days prior to enrollment;
* Any serious chronic or progressive disease;
* Known or suspected impairment or alteration of the immune system;
* Receipt of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation.
Vascular and Metabolic Effects of Vytorin

The investigator hypothesize that vytorin may improve vascular and insulin resistance in hypercholesterolemic patients


Eligibility Criteria:
Inclusion Criteria:

* hypercholesterolemia

Exclusion Criteria:

* overt liver disease, chronic renal failure, hypothyroidism, myopathy, uncontrolled diabetes (HbA1c \> 9%), severe hypertension, stroke, acute coronary events, coronary revascularization within the preceding 3 months, or alcohol abuse
Evaluation of Vepoloxamer in Chronic Heart Failure

The purpose of this study is to evaluate whether vepoloxamer can provide a blood chemical marker and functional benefit to damaged heart muscle cells. This will be evaluated by measurement of blood-based laboratory markers, exercise tolerance, and echocardiograms. In addition, the safety and blood levels of vepoloxamer in subjects with chronic heart failure will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 through 74
* Duration of documented heart failure \>3 months
* On stable concomitant medication regimen ≥4 weeks
* Left ventricular ejection fraction ≤35%
* Systolic blood pressure ≥90 mmHg

Exclusion Criteria:

* Severe valvular stenosis or primary valvular regurgitation as the cause of heart failure
* History of myocardial infarction, coronary artery bypass graft surgery, or percutaneous intervention within the prior 3 months
* Estimated glomerular filtration rate ≤45 mL/min/1.73 m2
* Acutely decompensated heart failure within 1 month prior to the screening visit
The Importance of Muscle Function in Patients With Disseminated Bladder Cancer

This study investigates if reduced muscle mass and muscle function predispose to poor completion of oncological treatment in patients with bladder cancer (including cancer of the renal pelvis, ureter and urethra) and if muscle mass and muscle function change during oncological treatment in these patients. It also evaluates biomarkers for sarcopenia.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* Age ≥ 18 år
* Histologically verified cancer of the renal pelvis, ureter, bladder or urethra regardless of type of histology
* ECOG performance status 0 - 3
* Meet the requirements for receiving oncological treatment (neoadjuvant chemotherapy for localized disease, chemotherapy or immunotherapy for disseminated disease).

Exclusion Criteria:

* Age \< 18
Tomosynthesis Vs. Contrast-Enhanced Mammography in Women with Personal History of Breast Cancer in Western Pennsylvania

This is a prospective clinical trial that will examine if contrast-enhanced mammography substantially improves breast cancer detection compared to mammography with tomosynthesis, with minimal increase in false-positives, in women with a personal history of breast cancer.

The investigators expect to show in a prospective clinical trial that, in women with a personal history of breast cancer, contrast-enhanced mammography substantially improves breast cancer detection compared to mammography with tomosynthesis, with minimal increase in false positives. The investigators expect a substantial increase in node-negative invasive cancers in particular. Because DBT will be interpreted first by one reader, and CEM will be interpreted first, and independently, by a second reader, there will also be an assessment of performance of tomosynthesis alone or CEM alone in this population. Participants will be invited to three rounds of annual screening with CEM. CEM must be performed at the time of or within 6 weeks of routine annual mammogram with tomosynthesis.

Eligibility Criteria:
Inclusion Criteria:

-Asymptomatic women, ages 30-85, with a personal history of breast cancer who have had at least one routine mammogram since treatment.

Exclusion Criteria:

* Women with a history of prior iodinated contrast reaction
* Women with implant(s) in the breasts to be screened (as this creates artifacts and diagnostic performance of imaging in women with implants likely does not generalize to those without implants, and the sample size with implants would be too small to infer conclusions)
* Women who have had bilateral mastectomy
* Women with a history of kidney failure or estimated glomerular filtration rate (eGFR) \< 45 mL/min
* Pregnancy or lactation
* Women actively being treated for cancer of any type with chemotherapy
* Lump or other breast symptoms
* Abnormality on prior breast imaging that is being followed.
Single-arm Trial to Evaluate the Role of the Immune Response to Talimogene Laherparepvec in Unresected Melanoma

The study is a phase 2, multi centered, single arm study designed to evaluate the correlation between cluster of differentiation 8-positive (CD8+) cell density and objective response rate in adults with unresected stage IIIB to IVM1c melanoma. This study will also evaluate the safety and tolerability profile of talimogene laherparepvec.

The study will explore the hypothesis that intratumoral CD8+ cell density at baseline correlates with objective response rate in adults with unresected stage IIIB to IVMIc melanoma treated with talimogene laherparepvec.

Eligibility Criteria:
Inclusion Criteria:

1. Provided informed consent prior to initiation of any study-specific activities/procedures
2. Subject with stage IIIB to IVM1c melanoma for whom surgery is not recommended
3. Candidate for intralesional therapy
4. Measurable disease with greatest diameter ≥ 10 mm
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
6. Adequate organ function

Other Inclusion Criteria May Apply

Exclusion Criteria:

1. Clinically active cerebral metastases.
2. Bone metastases
3. Primary ocular or mucosal melanoma
4. Active herpetic skin lesions or prior complications of herpes simplex virus type 1 (HSV-1) infection (eg, herpetic keratitis or encephalitis)
5. Requires intermittent or chronic systemic (intravenous or oral) treatment with an antiherpetic drug (eg, acyclovir), other than intermittent topical use
6. Female subject is pregnant or breast-feeding, or planning to become pregnant during study treatment and through 3 months after the last dose of talimogene laherparepvec
7. Female subject of childbearing potential who is unwilling to use acceptable method(s) of effective contraception

Other Exclusion Criteria May Apply