cyrilzakka/clinical-trials huggingface dataset:
Open-label, Follow-up of Doravirine/Islatravir (DOR/ISL 100 mg/0.75mg) for Participants With Human Immunodeficiency Virus-1 (HIV-1) Infection (MK-8591A-033)

The safety and tolerability of MK-8591A, a 2-drug fixed dose combination (FDC) of doravirine (DOR 100mg) and islatravir (ISL 0.75mg) will be evaluated in participants with Human Immunodeficiency Virus -1 (HIV-1) who were treated with DOR and ISL in earlier clinical studies.


Eligibility Criteria:
Inclusion Criteria:

* Is currently receiving DOR 100 mg/ISL 0.75 mg adult FDC tablet in an MSD-sponsored clinical study and has completed the last treatment visit.
* Is considered by the investigator to have derived clinical benefit from receiving DOR/ISL and for whom further treatment with DOR/ISL is considered clinically appropriate.
* Female is not pregnant or breastfeeding, and at least one of the following conditions applies: Is not a woman of childbearing potential (WOCBP); or is a non-pregnant WOCBP who agrees to the following during the intervention period and for at least 6 weeks after the last dose of study intervention: Not be sexually active, or if sexually active, to use an acceptable method of contraception; or is pregnant and continues to receive study intervention (where allowed by local regulations and as appropriate based on available data/local standard-of-care guidelines)

Exclusion Criteria:

* Is taking or is anticipated to require any prohibited therapies.
Optimal Management of Women With Wrist Fractures

To evaluate the effectiveness of a multifaceted intervention (reminder and educational material) in improving the evaluation of osteoporosis follow-up care of post-menopausal women with wrist fractures by their primary care physicians. The intervention is directed at improving the gap in continuity of care between emergency/fracture clinics and family physicians, and reducing knowledge gaps.

Numerous studies have demonstrated that women with wrist fractures have lower bone mineral density. Despite new guidelines for the care of such women, research has shown that they are not generally evaluated for osteoporosis. This care gap exists although it is known that wrist fractures are an important marker for subsequent fractures, such as a hip fracture, which represents a significant socio-economic burden to society.

Comparison: Cluster randomized trial of women and their physicians, both of whom receive educational material and reminder on post fracture osteoporosis evaluation. Comparison is to women and their physicians who receive standard post fracture information. Family practices are randomized to intervention or non-intervention group.

Eligibility Criteria:
Inclusion Criteria:

1. Postmenopausal women with low trauma distal radius fracture (confirmed by x-ray).
2. Can be taking Didrocal (etidronate), Miacalcin (calcitonin),or hormone replacement therapy .

Exclusion Criteria:

1. Women with fractures of the elbow, mid radius, scaphoid, or injury to wrists (without actual fracture).
2. Significant cognitive impairment (which would preclude them from filling out simple questionnaires).
3. Women already taking osteoporosis therapy, ie. either Fosamax (alendronate), Actonel (risedronate), or the selective estrogen receptor modulator, Evista (raloxifene).
Comparison of 68Ga-DOTA-FAPI-46 and 68Ga-DOTA-2P(FAPI)2 PET/CT in Patients With Various Types of Cancer

To evaluate the potential usefulness of 68Ga-DOTA-2P(FAPI)2 positron emission tomography/computed tomography (PET/CT) for the diagnosis of primary and metastatic lesions in various types of cancer, compared with 68Ga-DOTA-FAPI-46 PET/CT.

In order to enhance the tumor uptake and tumor retention time, we designed the dimer structure of fibroblast activation protein inhibitor (FAPI), a novel imaging agent that targeting cancer-associated fibroblasts expressed in various types of cancer, 68Ga-DOTA-2P(FAPI)2. Subjects with various types of cancer underwent contemporaneous 68Ga-DOTA-2P(FAPI)2 and 68Ga-DOTA-FAPI-46 PET/CT either for an initial assessment or for recurrence detection. Tumor uptake was quantified by the maximum standard uptake value (SUVmax). The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy of 68Ga-DOTA-FAPI-46 and 68Ga-DOTA-2P(FAPI)2 PET/CT were calculated and compared to evaluate the diagnostic efficacy.

Eligibility Criteria:
Inclusion Criteria:

* (i) adult patients (aged 18 years or order);
* (ii) patients with suspected or newly diagnosed or previously treated malignant tumors (supporting evidence may include magnetic resonance imaging (MRI), CT, tumor markers and pathology report);
* (iii) patients who had scheduled both 8Ga-DOTA-FAPI-46 and 68Ga-DOTA-2P(FAPI)2 PET/CT PET/CT scans;
* (iv) patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee.

Exclusion Criteria:

* (i) patients with non-malignant lesions;
* (ii) patients with pregnancy;
* (iii)the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.
Echogenic Versus Non-echogenic Needles for Venous Access

Randomized controlled intervention study comparing echogenic needles with non echogenic needles for ultrasound guided venous access in the subclavian vein.

Patients undergoing certain surgical procedures and patients in intensive care unit require a central venous catheter (CVC) for infusion of medicaments and for monitoring. Central venous access (CVA) can be performed both with a blind technique or an ultrasound guided technique. A common place for CVA is the subclavian vein.

While many guidelines recommend the use of ultrasound for jugular access, there are no explicit recommendations for subclavian CVA For ultrasound guided CVA procedures good needle visualization is important to successfully place the needle and catheter in the correct position.

Echogenic needles can give better needle visualization when performing ultrasound guided CVA procedures. Theoretically, the use of echogenic needles should improve performance time and success rates, and reduce complication rates due to a better needling control.

The investigators will investigate the use of echogenic needles for vascular access.

A prospective randomized controlled trial design will be used. Echogenic needles will be compared with non-echogenic (standard) needles. The main null hypothesis states that there is no difference in access time between the needles.

Eligibility Criteria:
Inclusion Criteria:

undergoing a surgical procedure requiring a CVC Patients must be at least 18 years of age. Patients that have given informed written consent.

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Exclusion Criteria:

* Patients that do not speak or understand Norwegian language.
* Skin disease or infection affecting the whole-body surface or within the area of examination.
* Patients with untreated coagulopathy
* Known vascular abnormality
* Any reason why, in the opinion of the investigators, the patient should not participate.
* Subject participates in a potentially confounding drug or device trial during the course of the study.
Physical Activity and Recreation School Program for Special Needs Individuals and Their Parents

The general purpose of this project; "Physical Activity and Recreation School" for the evaluation of physical activity behaviors of individuals with physical disabilities between the ages of 6-18, to increase the level of knowledge and awareness of these individuals and their parents, and to enable individuals with special needs to experience sports activities in the company of health and sports professionals who are experts in their fields. is to arrange. This project consists of three main topics as evaluation, training and experimentation.

During the evaluation phase, interactive roundtable activity, valid and reliable scales and physical assessments, and barriers and motivators for physical activity participation of individuals with special needs will be evaluated. A comprehensive interactive training seminar on physical activity will be held for individuals with special needs and parents during the training phase.

In the experimentation phase, children and adolescents with special needs will participate in training programs that include exercise and sportive activities suitable for the determined physical activity barriers and motivators, and will have the opportunity to experience exercises and sportive activities that they have not experienced before. The results of this project will provide gains in the analysis and application of physical inactivity, which is seen as an important public health problem in our country, for individuals with special needs, and will also guide many relevant institutions, health professionals and educators.


Eligibility Criteria:
Inclusion Criteria:

For Individuals with special needs;

* Between the ages of 6-18
* Being diagnosed with Cerebral Palsy, Neuromuscular Muscle Disease, Spina Bifida or having a chronic neurological or orthopedic problem that causes physical disability
* Being in a wheelchair/ able to walk with an assistive device or independently
* Have a cognitive level to understand and communicate questions
* Being residing in the province of Istanbul For parents of individuals with special needs;
* Being the mother or father of a special needs child or adolescent
* Volunteering for a special needs child to participate in the study
* Being able to participate in the activities to be held within the scope of the project on a full-time basis
* Have a cognitive level to understand and communicate questions
* Using a smart phone.

Exclusion Criteria:

For Individuals with special needs;

* Having a cognitive problem that will prevent the application of the evaluation parameters
* Failure to approve the assessment by the custodial parent
* Having had lower extremity surgery in the last 6 months
* Doing regular physical activity in the last 6 months
* Being a professional athlete For parents of individuals with special needs;
* Being illiterate.
* Not living with a special needs child.
Characterization of Immune Cells and Their Secreted Cytokines in Endometriosis Patients

The EUmetriosis project aims to address the most important unmet needs of endometriosis sufferers to advance patient care. The objectives cover all main aspects of disease management, including elucidating the pathogenesis, diagnosing the condition promptly and efficiently, facilitating care by implementing self-management strategies, raising awareness and promoting policy changes. The objectives comprise individual yet intersecting pieces of a puzzle which, when positioned correctly, can immensely improve disease perception and understanding to enhance patient care. The project will prioritise the needs and wants of modern-day patients, focused on providing easily accessible and noninvasive therapeutic options. Combining all these elements in a well-coordinated project is pivotal to relieving the heavy burden endometriosis places on European society as a whole.

EUmetriosis will generate new knowledge in the field of endometriosis, its drivers and consequences, as well as biological determinants, which will result in a better understanding of endometriosis pathogenesis and the factors involved. Specifically, the project will assess the role of the immune cells, diet, cognitive behaviour and other related factors in disease pathogenesis, and develop strategies on how to alleviate endometriosis-associated pain, enhance quality of life and improve outcomes for patients. The knowledge base (like the association between nutrition, epigenetics, the microbiome and endometriosis) and methodologies generated within the project will drive the fields of gynaecology, primary care, pain medicine, urology and gastroenterology forward. Finally, through the collection of evidence for effective self-management strategies, the project will pave the path for more patient-tailored health policies. The project aims to link different stakeholder groups involved in this field, like clinicians, patients, healthcare insurers/payers and other researchers in women's health. With this multidisciplinary consortium, EUmetriosis will maximise its impact by creating therapeutic and diagnostic endometriosis solutions best suited to real-world applications, with a clear strategy for implementation.

Eligibility Criteria:
Inclusion Criteria:

* Women with a clinical and/or ultrasound diagnosis of endometriosis who are candidates for surgery
* Age between 18 and 50 years
* Pre-menopausal status
* Experiencing regular menstruation
* Willing to collect menstrual effluent
* Signature of informed consent to the study

Exclusion Criteria:

* Age below 18 years
* Post-Menopausal status
* Presence of Crohn's disease
* Presence of Ulcerative Colitis
* Presence of short bowel syndrome or another chronic inflammatory disease
* Use immunosuppressive medication
* Receiving contraceptive hormone therapy
* Pregnant
* Presence/history of malignancy
Community Health Workers and Teleaudiology as a Culturally-relevant Approach to Improving Access to Hearing Health Care

The purpose of this study is to test the feasibility of a teleaudiology intervention with assistance from Community Health Workers to improve access to hearing health care.


Eligibility Criteria:
Inclusion Criteria:

* Bilateral hearing loss within the fitting range of study hearing aids

Exclusion Criteria:

* Medically unqualified to receive hearing aids
* Current hearing aid user
* Cognitively impaired
Neurally Adjusted Ventilatory Assist (NAVA) in Pediatric Patients

The purpose of this study is to find out if NAVA-technology is better in detecting patients own inspiratory efforts during mechanical ventilation than currently used flow-triggering in PRVC (pressure regulated volume controlled) ventilation, and if NAVA gives real benefits for patients or not.

The investigators study hypothesis is that NAVA-technology can detect spontaneous inspiration more accurately than currently used methods, and thus will lead to more smooth adaptation to mechanical ventilation in pediatric patients. The investigators expect this to decrease the time of ventilatory support needed.

Asynchrony means that the timing of support given by ventilator is different from patients own breathing pattern. Asynchrony during ventilatory care may increase the risk for complications, make the weaning more difficult and may affect the survival rates.

In our study we randomly treat pediatric patients needing ventilatory support with neurally adjusted ventilatory assist and pressure controlled or PRVC-ventilation. We are willing to find out if there are any special benefits for patients with each treatment mode.

Eligibility Criteria:
Inclusion Criteria:

* All children from term newborn (37+0 gestational week) to 16-year-old needing ventilatory care at least 30 minutes

Exclusion Criteria:

* Any condition that prevents feeding tube positioning. Critical ventilatory or perfusion problems.
Evaluation of Regional Myocardial Dynamics at Physical Stress in Essential Hypertension

The study hypothesis is stress-related regional tissue dynamics is related to left ventricular outflow tract blood flow.


Eligibility Criteria:
Inclusion Criteria:

* Essential hypertension

Exclusion Criteria:

* History of Myocardial Infarction
* Diabetes Mellitus
* Renal Failure
* Orthopedic problems
The Drift-Reduction for Improved FFR Using Fiberoptic Technology (DRIFT) Study

The primary objective of this study is to assess the accuracy, efficacy, and durability of the OpSens Medical OptoWire Deux pressure wire in the assessment of angiographically intermediate proximal left anterior descending coronary artery (LAD) stenoses in clinical practice.

This study is designed as a prospective, observational in nature, multi-center, single-arm, clinical registry to estimate the ischemic burden of angiographically intermediate proximal LAD stenosis in clinical practice using the OpSens Medical OptoWire Deux FFR system. Subjects with stable angina or unstable angina who are found to have an intermediate proximal LAD stenosis on coronary angiography with anatomy amenable to PCI and underwent physiological lesion assessment with the OptoWire Deux pressure wire and OCT as part of their routine procedures using standard of care techniques will be enrolled. Patients meeting enrollment criteria will be offered the opportunity to enroll in this observational registry post-procedure. All patients enrolled in this study are expected to be evaluated and treated using a standard of care technique. This study will enroll a total of 60 patients at Columbia University Medical Center and St. Francis Hospital.

Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects, \>18 years of age.
* Patients with stable angina, unstable angina or non-ST segment elevation myocardial infarction (if the LAD lesion is the non-culprit lesion) and in whom an intermediate proximal LAD de novo stenosis (30-80%) with TIMI flow 3 has been identified on angiography. Note: Patients with multi-vessel disease can be enrolled.
* Patients have had fractional flow reserve (FFR) and optical coherence tomography (OCT) of the LAD with the OpSens FFR system as part of their routine evaluation as standard of care procedure.
* Provides written, informed consent and HIPAA consent to use the data in a clinical study.

Exclusion Criteria:

(General exclusion criteria)

* Patients presented with NSTEMI with the LAD involved as the culprit lesion
* Any ST-elevation myocardial infarction within the past 30 days.
* Hemodynamic instability requiring vasopressor or mechanical circulatory support.
* Prior heart transplant.
* Known left ventricular ejection fraction ≤40%.
* LAD supplying akinetic or severely hypokinetic territories if already known based on prior imaging.
* Patient is enrolled in another clinical study that may impact the results of this study.
* FFR not acquired per instructions for the OpSens Wire.
* LAD Lesion not assessed with OCT.

(Angiographic exclusion criteria)

* Thrombolysis in Myocardial Infarction (TIMI) grade 2 or lower at baseline angiography.
* Target lesion involves left main (stenosis \>50%).
* Previous percutaneous coronary intervention (PCI) with stent in LAD or left main trunk.
* Presence of chronic total occlusion in any vessel.
* Presence of a side branch≥2.75 mm with ≥70% stenosis in the LAD.
* Bifurcation lesion that resulted in the stent implantation of a side branch.
Acceptability and Tolerance Study of a New Oral Nutritional Supplement (ONS)

Tolerance and Acceptability of new oral nutritional supplement - AYMES PARIS

To evaluate tolerance and acceptability of AYMES PARIS in patients requiring supplementary oral nutritional support compared with currently available alternatives, measuring outcomes of GI effects, Compliance, product preference,convenience etc.

To obtain data to support an ACBS submissions for AYMES PARIS (to allow for prescription in the community at NHS expense).

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (≥18 years) who are able to communicate their views regarding acceptability.
* Patients established on an oral nutritional supplement, being prescribed 1-2 ONS providing approximately 300kcal/day
* Patients expected to require oral nutritional supplementation for at least 2 further weeks.
* Informed consent obtained.

Exclusion Criteria:

* Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study
* Patients requiring a milk-free diet
* Patients with medical or dietary contraindication to any feed ingredients (see appendix 2 of protocol for full list)
* Patients with significant renal or hepatic impairment
* Patients with swallowing impairment requiring thickened fluids
* Patients with inflammatory bowel disease or previous bowel resection.
HPV Multilevel Intervention Strategies Targeting Immunization in Community Settings (HPV MISTICS)

This intervention study will use parent-, provider-, and health center-level strategies to promote HPV vaccination among 11-17 year olds receiving care in 8 community health centers in Florida, will explore factors related to the intervention effect, and will explore implementation outcomes of the intervention.

The goals of this multi-level intervention study are to: 1) test whether HPV MISTICS intervention increases human papillomavirus (HPV) vaccine initiation and completion rates among 11-17-year-old adolescents in 8 Health Choice Network-affiliated community health centers in Florida. 2) Explore other factors related to the intervention effect. 3) Explore implementation outcomes (i.e., reach, adoption, implementation, maintenance, and sustainability) and identify implementation barriers and facilitators with a focus on equity. The study will use parent-, provider-, and health center-level strategies to promote HPV vaccination.

Eligibility Criteria:
Inclusion Criteria:

* For Staff:
* 18 years of age or older
* Working within the participating Federally Qualified Health Center system
* Able to read, write and speak English
* For Providers:
* 18 years of age or older
* Working within the participating Federally Qualified Health Center system
* Interacting with parents of adolescents ages 11-17
* Able to read, write and speak English
* For parents:
* Parent of 11-17 year old child that has received care within the prior two months at one of the participating Federally Qualified Health Centers
* Whose child has not initiated or completed the HPV vaccine series at the time of their last visit
* Able to read, write and speak English or Spanish, or Haitian Creole