cyrilzakka/clinical-trials huggingface dataset:
Brachial Artery Peak Velocity Variation to Predict Fluid Responsiveness

The investigators designed this study to determine the predictive value for predicting fluid responsiveness of noninvasive evaluation of respiratory variation of peak velocity in brachial artery, in mechanically ventilated patients with acute circulatory failure.

Predicting the hemodynamic response to fluid administration (or fluid responsiveness) in critical ill patients is still a matter of concern, since fluid overload could worse the clinical situation of these patients. Parameters of fluid responsiveness usually require an invasive monitoring (like arterial pulse pressure variation).

We hypothesize that noninvasive evaluation of respiratory variation of peak velocity in brachial artery using Doppler ultrasound could provide a feasible estimation on fluid responsiveness in mechanically ventilated patients with acute circulatory failure.

Eligibility Criteria:
Inclusion Criteria:

* Patients with controlled mechanical ventilation, equipped with an indwelling radial artery catheter and for whom the decision to give fluids will be taken because the presence of one or more clinical signs of acute circulatory failure:

  * systolic blood pressure \<90 mmHg (or a decrease \>50 mmHg in previously hypertensive patients)
  * the need of vasopressor drugs
  * oliguria (urine output \<0.5 ml/kg/min for at least 2 h)
  * tachycardia
  * delayed capillary refilling
  * the presence of skin mottling

Exclusion Criteria:

* Contraindication for the volume administration: evidence of fluid overload and/or of hydrostatic pulmonary edema
* Patients with instable cardiac rhythm
Effects of Simvastatin and Ezetimibe on Cardiovascular Risk Markers in Patients With Dyslipidemia

Coadministration of drugs is common in the pharmacologic treatment of dyslipidemia, with statins and ezetimibe generally constituting the medication of choice. By acting at different levels, the combination of these drugs allows the therapeutic objective to be achieved. However, it is not known how these drugs qualitatively affect the composition of lipoprotein subfractions, which differ in size and atherogenic potential. The investigators set out to evaluate this effect as well as their effects on inflammatory, oxidative stress and endothelial function parameters.

The study consisted of a randomised parallel trial and took place during a period of 2 months. A total of 42 hyperlipidemic patients were randomly assigned to one of 2 groups: one received simvastatin (40 mg/day) and the other received ezetimibe (10 mg/day) for 4 weeks, after which both groups were administered combined therapy for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.

Eligibility Criteria:
Inclusion Criteria:

* LDL cholesterol concentration of between 160-190 mg/dl in patients with less than 2 cardiovascular risk factors
* LDL concentration of between 130-160 mg/dl in patients that presented 2 or more cardiovascular risk factors.

Cardiovascular risk factors were defined as: age (≥ 45 years in men and ≥55 years in women), a smoking habit, hypertension (≥140/90 mmHg), diabetes mellitus, a high-density lipoprotein (HDL) cholesterol concentration of ≤ 40mg/dl, and a family history of cardiovascular disease.

Exclusion Criteria:

* Triglyceride concentration \> 400 mg/dl
* Diabetes Mellitus
* Kidney, liver, or thyroid disease
Comparison Between Different Investigations Used in Intraocular Lens Calculation in High Myopic Cataractous Patients

the purpose of the study is to compare the accuracy of optical and ultrasonic biometry in intraocular lens (IOL) calculation in high myopic cataractous patients

* Prospective interventional (QUASI experimental) comparative study
* This study will be conducted on high myopic cataractous patients scheduled for phacoemulsification and IOL implantation in department of ophthalmology, Sohag university
* patients will be divided into 2 groups one will be subjected to intraocular lens (IOL) calculation by optical biometry the second one will be subjected to intraocular lens (IOL) calculation by ultrasonic biometry
* postoperative auto refraction after I month

Eligibility Criteria:
Inclusion Criteria:

* patients with simple cataract not associated with other pathologies suitable for phacoemulsification and 1ry IOL implantation With axial length (AXL) equal to or greater than 26.5mm

Exclusion Criteria:

1. History of trauma
2. Associated pathologies such as optic neuropathy, age related macular degeneration, macular edema, retinal detachment, , ocular inflammation, retinitis pigmentosa, proliferative diabetic retinopathy
3. corneal opacities or irregularities, scars, dystrophy or ectasia
4. Patients who underwent previous corneal surgery (including refractive surgery)
5. Patients having intraoperative complications as inability to achieve secure 'in the bag' placement of the IOL (i.e. due to posterior capsule rupture, vitreous loss, weak zonules, or zonular rupture)
Effect of Duramesh™ on Hernia Formation After Ileostomy Closure, Randomized Controlled Trial

Diverting ileostomy is frequently utilized to protect high-risk anastomoses, though it is not shown to reduce the leak rate it may reduce the severe consequences of an anastomotic leak. Ileostomy will be reversed with restoration of continuity in majority of patients. Stoma site incisional hernias after ileostomy closure are complex hernias that can be associated with abdominal pain, discomfort, and a diminished quality of life. Duramesh™ non-absorbable polypropylene suture is a hollow core, microporous, cylindrical suture made off in polypropylene filaments that are loosely braided and bonded to each other with heat and pressure. The Aim of this study is to evaluate Duramesh™ suture vs standard closure on rates of hernia formation after ileostomy closure.


Eligibility Criteria:
Inclusion Criteria:

* • Patients undergoing ileostomy closure after surgery for cancer All patients with a stoma (independent of diagnosis)

  * Age 18 or greater
  * Surgical oncology patient where routine radiologic surveillance for malignancy is planned
  * Patient accepts participation and gives informed consent

Exclusion Criteria:

* • Pregnancy

  * Prior mesh hernia repair at laparotomy site
  * Life expectancy less than 1 years
  * Patient is unable / unwilling to provide informed consent
  * Patient is unable to comply with the protocol or proposed follow-up visits
  * Patient is enrolled in another hernia study
  * Non-English-speaking participants
  * Data from children will not analyzed in this study.
  * Cognitively Impaired Adults: Data from cognitively impaired adults will not analyzed in this study.
  * Adults Unable to Consent: Data from adults unable to consent will not analyzed in this study.
Lipid Profile as Predictor of Adverse Maternal and Neonatal Outcomes: A Pilot Study

The purpose of this study is to ascertain lipid profiles during pregnancy, specifically during the 24-28 week gestation and again near term at 36 weeks gestation. The research team are investigating whether lipid profiles can predict adverse maternal and neonatal outcomes.

The purpose of this research is to investigate whether lipids profiles during pregnancy impact LGA and other adverse outcomes in pregnancy. Participants will have blood drawn twice; the first blood work is a fasting blood draw (separate blood draw) on the same day but preceding the standard glucose test. The second blood draw is drawn at the time of routine clinical care (third trimester blood work).

Patients will be approached at the time of the anatomy ultrasound for participation. If they consent to participate they will have a FASTING lipid panel drawn at the time of their 24-28w GCT and again at the time of their 36w third trimester labs. Patients will receive a reminder call prior to scheduled 24-28 week appointment for fasting instructions.

Eligibility Criteria:
Inclusion Criteria:

* Singleton pregnancy
* Ages 18-45
* Presentation to prenatal care by the 2nd trimester
* Prenatal care at Mount Sinai Hospital
* Anticipated delivery at Mount Sinai Hospital

Exclusion Criteria:

* Multiple gestations
* Preexisting hyperlipidemia
* Preexisting diabetes
* Delayed presentation to prenatal care after the 2nd trimester 5. Prenatal care or delivery outside of Mount Sinai Health System
Effect of Motorized Cryotherapy on Early Effusion, Swelling, and Pain After Anterior Cruciate Ligament Reconstruction

To test the efficacy of motorized cryotherapy on early effusion, and pain after ACL reconstruction

To test the efficacy of motorized cryotherapy on early effusion, and pain after ACL reconstruction compared to classical ice bagging

Eligibility Criteria:
Inclusion Criteria:

* Acute ACL ruptured patient

Exclusion Criteria:

* Combined meniscal injury requiring surgery
* Combined ligament injury requiring surgery
* Combined chondral injury requiring surgery
* Previous surgery history on corresponding knee
* Allergic to cold
Investigation of the Clinical Performance of Biatain Fiber Ag on Burns

The goal of this study is to test a new gelling fiber wound dressing with silver on patients with a partial thickness burn wound, which is infected or at risk of infection.

Participants will be asked to wear the test dressing in a two weeks period(+/- 2 days) consisting of 3-4 study visits, and will have the dressing changed once pr. week at the research facility. The wound will be cleaned, assessed and photos will be uploaded to a digital software system.

The clinical investigation is a non-comparative, one-armed, open-labelled, multi-centre study.

The test product, Biatain Fiber Ag is a non-CE-marked gelling fiber wound dressing, containing silver. The product is intended for moist wound healing and exudate management of moderate to high exuding wounds. The product has a classification III, as it contains the active ingredient silver.

The overall purpose of this investigation is to obtain clinical data supporting effectiveness of Biatain Fiber Ag to obtain the CE-mark in EU.

The total study duration for the subject will be approximately two weeks (+/- 2 days), consisting of a two-week test period and 4 study visits (V0/V1, V2 and V3). V3 will also terminate the 2-week study period.

The primary endpoint is percentage of wounds healed within 14 days (≥ 95 % reepithelialisation) The clinical investigation will be conducted in a total of 50 eligible subjects with a partial thickness burn wound that are infected or at risk of infection.

Eligibility Criteria:
Inclusion Criteria:

1. Has signed informed consent
2. Is between 18 -65 years (both included)
3. Is capable of following study procedure (assessed by investigator).
4. Has a partial thickness burn wound
5. Has a burn wound that is infected or at risk of infection (assessed by investigator)
6. The size of burn (including both study wound and non-study injuries) has a Total Body Surface Area (TBSA) less than 10% (assessed by investigator).
7. The wound should fit under a 20x30 cm dressing (600 cm2) or smaller
8. The shape and location of the wound should be suitable for photo capture (assessed by the investigator).
9. Has a wound that has medium to high level of exudate (assessed by the investigator)
10. Is suitable to use the test product for wound treatment (assessed by the investigator).

Exclusion Criteria:

1. Is pregnant/breastfeeding
2. Is currently receiving or has within the past 60 days received radio- and/or chemotherapy (low doses radio- and/or chemotherapy is allowed for other indications than cancer if assessed by investigator not to influence study wound area)
3. Known history of skin sensitivity to any components of the test dressings
4. \>72 hours from time of injury
5. Intake of antibiotics within one week before the start of the enrolment
6. Use of chemical debridement
7. Participation in any other clinical studies that can compromise this study treatment (assessed by the investigator).
MyPEEPS Mobile Plus: A Multi-Level HIV Prevention Intervention for Young MSM

MyPEEPS Mobile Plus, a multi-level intervention for improving HIV prevention outcomes in YMSM, is a novel and evidence-driven approach using mobile technology to deliver HIV prevention information specifically developed for YMSM. Building on strong preliminary work, the proposed research is the next logical step in a body of work designed to assess whether refinement of this mobile intervention used in combination with virtual PrEP Peer Navigation will result in improvements in PrEP uptake and a reduction in HIV-related behavior. This is key to advancing HIV prevention among HIV-negative US persons at extremely high-risk for HIV seroconversion.

This study expands MyPEEPS Mobile to develop MyPEEPS Mobile Plus, a multi-level intervention comprised of MyPEEPS Mobile with added PrEP content (based upon expert advisory and youth feedback) + PrEP E-Peer Navigation to overcome the challenges of PrEP initiation, adherence, and persistence among YMSM. Peer navigation is an evidence-based, widely recommended intervention for reaching youth and MSM for HIV-related care outcomes, with evidence of acceptability among racial/ethnic minority YMSM for PrEP. Peer navigation addresses common reasons for failing to begin or maintain PrEP use, including low perceived risk, structural or logistic barriers to care engagement, and anticipated side effects. Relative to in-person and group-based HIV prevention programs, behavioral interventions with digital and virtual components can have vast reach and present unique potential to rapidly scale delivery to very large and hidden groups. Therefore, the investigators propose to conduct a randomized controlled trial to test the efficacy of MyPEEPS Mobile Plus (a multi-level intervention comprised of MyPEEPS Mobile + PrEP E-Peer Navigation) for promoting initiation, adherence, and persistence of PrEP and decreased HIV risk behavior in YMSM. Building upon the team's demonstrated ability to enroll large numbers of young racially and ethnically diverse YMSM and extensive experience developing mobile health interventions, the proposed study will test the efficacy of this expanded, multi-level mobile HIV prevention intervention emphasizing PrEP. If efficacious, it will increase PrEP initiation, adherence, and persistence and decrease overall HIV risk in diverse YMSM in the US.

Eligibility Criteria:
Inclusion Criteria:

* 17-25 years of age
* identify as male, non-binary, or genderqueer
* male sex assigned at birth
* understand and read english
* own a smartphone
* report condomless anal sex with a male in the past year
* HIV-negative (OraQuick verified)

Exclusion Criteria:

* HIV Positive
* If study staff determine participant unable to consent due to obvious and severe cognitive impairment or under the influence of drugs or alcohol
* Transgender identity
* currently report consistent use of PrEP
Team-Based Home Blood Pressure Monitoring

The overall goal of this study is to identify and rigorously evaluate strategies for implementing and sustaining team-based home blood pressure monitoring (TB-HBPM) within primary care.

The TB-HBPM intervention is a multifaceted program involving patient transmission of blood readings to EHR and clinical decision support. Implementation strategies include group-based education on hypertension measurement, target blood pressure goals, drug and lifestyle management, referral to community resources, and team training designed to optimize the coordination of hypertension care, and monthly audit and feedback reports to teams and clinicians.

Hypertension control rates are suboptimal in many primary care practices with persistent racial disparities in control. Team-based home blood pressure monitoring (TB-HPBM) involving patient transmission of their home blood pressure readings in real-time to their clinical team has been shown to improve blood pressure control. There is an urgent need to implement TB-HBPM into practice. The overall objective of this research is to assess implementation strategies that mitigate barriers and leverage facilitators to TB-HBHM on hypertension control and disparities between Black and White patients. The study team and investigators will use mixed methods to assess the process and generate knowledge to facilitate broader uptake of TB-HBPM.

Aim 2: Deploy theorized implementation strategies using a type-2 hybrid stepped-wedge randomized cluster trial The department of family medicine will roll out the clinical intervention (TBHBPM).

To improve rigor in evaluation, the study biostatistician will use computer-generated numbers to randomly assign each of the eight suites to when they will begin the intervention during one of three wedges (Figure 1). The study team and investigators will randomize two suites in the first wedge and three each to the second and third wedge.

Aim 3: Assess the impact of implementation strategies using specific metrics based on RE-AIM

Aim 4: Test theoretical assumptions underlying the implementation strategies

Eligibility Criteria:
ELIGIBILITY CRITERIA

Clinicians and Staff Eligibility Criteria Practice employees (practice leaders, administrators, clinicians, or staff) that work with hypertensive patients during the study period (scheduling appointments, coordinating care, measuring blood pressure, responding to questions, and/or treating their blood pressure)

Patient Inclusion Criteria

* Current HFM patient 18-85 years of age with hypertension diagnosis
* Diagnosis of hypertension based on ICD-10 codes of I10-I14
* at least one HFM health visit and hypertension diagnosis beginning no later than 7/1/2021.

Patient Exclusion Criteria

* Not current patient in the participating practices
* Diagnosis of dementia, end-stage renal disease, and/or in hospice
* Currently pregnant
Prevalence of Diabetic Retinopathy in São José do Rio Preto-SP-Brazil

Prevalence of Diabetic Retinopathy in São José do Rio Preto-SP-Brazil

Abstract

Objective: To determine the prevalence and characteristics of diabetic retinopathy (DR) among patients from São José do Rio Preto-SP-Brazil .

Local: Departamento de Retina e Vítreo do Hospital do Olho de Rio Preto (HORP)

Methods: Design: population-based cross-sectional study. The study sample, of 710 patients was derived from the HIPERDIA (Diabetes and High-blood pressure social health care program) of São José do Rio Preto . All patients , known to have diabetes , underwent an eye examination by biomicroscope and indirect ophthalmoscope to check for any signs of DR through dilated pupils. Participants were also interviewed and examined to determine their demographic characteristics, medical conditions and the realization of previous fundoscopic eye examination. Statistical studies were done with t -Student test , Fisher test or chi-square test.

Prevalence of Diabetic Retinopathy in São José do Rio Preto-SP-Brazil

Abstract

Objective: To determine the prevalence and characteristics of diabetic retinopathy (DR) among patients from São José do Rio Preto-SP-Brazil .

Local: Departamento de Retina e Vítreo do Hospital do Olho de Rio Preto (HORP)

Methods: Design: population-based cross-sectional study. The study sample, of 710 patients was derived from the HIPERDIA (Diabetes and High-blood pressure social health care program) of São José do Rio Preto . All patients , known to have diabetes , underwent an eye examination by biomicroscope and indirect ophthalmoscope to check for any signs of DR through dilated pupils. Participants were also interviewed and examined to determine their demographic characteristics, medical conditions and the realization of previous fundoscopic eye examination. Statistical studies were done with t -Student test , Fisher test or chi-square test.

Results: Among 710 screened patients 112 had some degree of diabetic retinopathy and the overall standardized prevalence of any retinopathy was 16,3%., including 90 (80,4%) with non-proliferative and (22) 19,6 % with proliferative diabetic retinopathy. Only 143 patients (68,7%) had a history of previous fundoscopic eye examination.

Conclusion: This study demonstrated that DM and their complications are a important public health problem. The duration of DM and glicemic control is strongly associated with DR . Prevention programs with periodic fundoscopic exams shows to diminished the prevalence of this ocular disease.

Keywords: Diabetes, Retinopathy, Prevalence, Population.

Eligibility Criteria:
Inclusion Criteria:

* Patients with Diabetes Melittus

Exclusion Criteria:

* Patients without Diabetes Melittus
A Comparison of Intravascular Penetration With Curved Needle and Straight Needle During S1 STE

The goal of this observational study is to compare in intravasation rate during S1 transforaminal epidural injection between using a straight needle and a curved needle. The main question it aims to answer are:

The main question it aims to answer is:

• whether there is a difference in intravascular rate between using a straight needle and a curved needle in S1 transforaminal epidural injection

Participants in this study will be randomly assigned to receive an S1 transforaminal epidural injection using either a straight needle or a curved needle. The researchers will then observe the intravasation rate and compare it between the two groups.


Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for a lumbar 1 epidural nerve block in the outpatient department of anesthesiology and pain medicine at Kyungpook National University Hospital.

Exclusion Criteria:

1. Patients with a history of allergy to local anesthetics or steroids
2. Patients with a history of allergy to contrast media
3. Patients with a bleeding tendency
4. Patients with symptoms of infection in the sacroiliac region
5. Patients under 18 years of age or over 80 years of age
6. Patients who are pregnant or planning to become pregnant
7. Other medically incapable of consent, such as the mentally retarded.

Translated with www.DeepL.com/Translator (free version)
Comprehensive Tobacco Cessation for Cancer Patients and Survivors

The purpose of this research study is to learn how best to incorporate tobacco cessation treatment into clinical care for cancer patients, survivors, and caregivers.

The goal of this study is to generate knowledge regarding the feasibility and acceptability of integrating tobacco cessation treatment into clinical care for cancer patients, survivors, and caregivers. The evidence base regarding tobacco treatment is solid: pharmacology (nicotine replacement therapy (and/or), bupropion, or varenicline) in combination with behavioral counseling yields the best results with respect to cessation rates. What remains unclear is how best to offer and implement this comprehensive treatment in the context of a cancer center-especially in a patient population facing social determinants of health that may not be in favor of tobacco cessation. Thus, in this study, the investigators are offering the "gold standard" tobacco treatment and assessing feasibility and acceptability of these procedures in order to inform future efforts to optimize treatment delivery for this unique population and setting. The intervention for this protocol was approved for standard of care use.

Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated informed consent form
* Stated willingness to comply with study procedures and availability for the duration of the study
* Have a documented history of cancer of any type, whether active or in remission
* Identify as a current or recently-quit tobacco user

Exclusion Criteria:

* Not a VCUHealth patient
* Non English-speaking