cyrilzakka/clinical-trials huggingface dataset:
Implementation of a Population Health Chronic Disease Management Program

A pilot program was created by the network's primary care leadership team at Massachusetts General Hospital. A population health management program was implemented for chronic disease management. The investigators evaluated quality of care process and outcome measures over the first six months of the program and compared practices assigned a central population health coordinator to those not assigned this support.

A pilot program was created by the network's primary care leadership team at Massachusetts General Hospital. They hired and allocated 4 population health coordinators (PHCs) as part of a pilot project to centralize population health management efforts to improve quality of care for chronic disease management. The network did not have sufficient resources to implement a PHC in all of the 18 network practices. So the program's team invited practice leaders to participate and the PHCs were allocated by program's leadership team based on a variety of factors including responses from the practice leader, baseline quality scores, size of the practice, nature of the practice (health center vs not), and location of the practice (on campus or community based). These decisions were made in a way that sought to equitably distribute available PHC resources within the practice network as a way to get network buy-in and maximize the impact of the program, both for practices with and without PHCs. In this study, the investigators evaluated quality of care process and outcome measures over the first six months of the chronic disease management program. The investigators hypothesized that practices assigned a central PHC would have greater performance increases in quality measures compared to practices that were not assigned a PHC.

Eligibility Criteria:
Inclusion Criteria:

* Diabetes mellitus (type 1 or type 2), or cardiovascular disease (including coronary artery disease, peripheral vascular disease, and cerebrovascular disease), or hypertension
* Breast cancer: women 50-74 years of age
* Cervical cancer: women 21-64 years of age
* Colorectal cancer: men or women 52-75 years of age

Exclusion Criteria:

* Patients not connected with a specific network physician or practice
* Patients who switched between PHC and non-PHC practices during the follow-up period
* Breast: bilateral mastectomy
* Cervical: total hysterectomy Colorectal: total colectomy
Assessment of Disease Burden in Hairy Cell Leukemia

Drug-free, single-center, prospective observational pilot study in hairy Cell Leukemia patients

The V600E gene lesion of B-raf, specific and almost always present in patients with hairy cell leukemia, correlates with the presence of neoplastic cells, therefore of active disease. The measurement of the fractional abundance of the mutated gene, by ddPCR, could therefore constitute a method of molecular assessment of the minimal residual disease. In addition, the values of fractional abundance (FA) of the mutated allele obtained can be integrated coherently in patients' clinical context, along with their PB counts and BM findings.

Primary objective Verify whether the absence of mutation at the end of treatment, indicative of a state of complete molecular response to therapy, can represent a predictor of long treatment-free survival.

Secondary objectives Verify the association between the absence of mutation and the duration of response in patients who do not need treatment for at least 5 years after only one treatment with purine analogues (cladribine and pentostatin) and judged in CR according to current criteria.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed diagnosis of HCL patients:

   1. newly diagnosed and candidates for first-line cytoreductive treatment with analogues purines or
   2. in relapse after a previous line of treatment, with indication for rescue therapy (repetition of a purine analogue; use of targeted or innovative drugs), except splenectomy or
   3. in CR for at least 5 years after a first line of treatment, in the absence of clinical alterations indicative of a state of hematological relapse, or in any case in the absence of an indication for a new line of cytoreductive therapy (time-to-next treatment exceeding 5 years).
2. Age ≥ 18 years at enrollment
3. Signature of written informed consent

Exclusion Criteria:

1. Concomitant second malignancy.
Anesthetic and Dilating Gel for Cataract Surgery

To prepare the eye for cataract surgery, drugs must be given to the eye to allow for surgery to take place. Traditionally, dilating drops and drops containing NSAIDs (to control inflammation) are given to the patient well in advance of surgery at repeated time intervals. As well, a gel containing lidocaine is applied to the eye just prior to surgery to anesthetize (reduce pain and feeling) in the area of the eye. Although effective, the procedure is time-consuming and costly for nursing staff. Recently, a few hospitals have reported success in mixing the pupil-dilating and NSAID drops with the lidocaine gel, creating an "anesthetic dilating gel". Although success has been reported, there have been no studies to clearly demonstrate that the "anesthetic dilating gel" is as effective at dilating the pupil and reducing sensitivity of the cornea during surgery than the traditional methods of drops and gel. It is possible that the dilating gel is less effective due to slower diffusion of drugs into the eye. The study will compare the effectiveness of the anesthetic dilating gel with the standard pre-operative pharmacologic regimen for cataract surgery. Stability (maintaining effectiveness over time) and contamination of the study gel will also be assessed. If the dilating gel is shown to be as effective in regards to pupil dilation and corneal anesthesia, while maintaining stability and sterility over time, hospitals can be encouraged to use such a anesthetic dilating gel routinely during pre-operative procedures before cataract surgery.


Eligibility Criteria:
Inclusion Criteria:

* scheduled for first cataract surgery (i.e., first eye)

Exclusion Criteria:

* previous ocular surgery,
* pseudoexfoliation syndrome,
* diabetes,
* herpetic eye disease,
* posterior synechiae,
* previous uveitis
Motivational Interviewing to Increase Parent Engagement in Preventive Parenting Programming

Evidence-based programs aimed at enhancing parenting skills are effective, and pediatricians identify many parents who could benefit from such programs. Low-income children have high rates of behavior problems and their family system and environmental exposures often lead to cumulative and daunting levels of risk for poor functional outcomes; their parents are highly likely to benefit from parenting supports. However, low-income families are the most likely to drop out of parenting interventions, meaning the families and children with the greatest need receive the least support. Fewer than 25% of low-income families recruited to parenting programs will participate in even one session, and only about half of these parents will participate in more than half of the sessions offered. The aims of this trial are:

Aim 1: To test the hypothesis that the provision of motivational interviewing (MI), as compared to an attention control (AC) condition, will increase the engagement of low-income parents of preschoolers in an evidence-based parenting skills group (the Incredible Years Series (IYS)). For this study, the outcome of engagement is operationally defined as intention to attend IYS sessions, attendance, and satisfaction with the IYS program.

Aim 2: To test the hypothesis that the effect of MI on engagement in IYS will be impacted by the following moderators: parenting self-efficacy, child behavior problems, and maternal depression.

The investigators hypothesize that the effect of MI on engagement will be greater among parents with lower parenting self-efficacy and parents of children with more behavior problems, but less among parents with more maternal depressive symptoms.

The investigators will use a stratified, randomized controlled trial (RCT) design to evaluate the impact of MI on parent engagement in a well-validated preventive parenting skills intervention, the Incredible Years Series (IYS).


Eligibility Criteria:
Inclusion Criteria:

* all children enrolled in the Head Start agencies involved in this study, who were randomized to the study arm involving the Incredible Years Series

Exclusion Criteria:

* child is a foster child
* parent or child cannot communicate in English
SENSIMED Triggerfish Sensor Sizes

This is a study investigating the effect of various SENSIMED Triggerfish sensor lens sizes on the recorded IOP related patterns in 10 healthy volunteers. Each volunteers receives 4 24-hours sessions of pattern recording on one selected eye (study eye). Each of the sensor lens sizes is placed on the eye in the different sessions. Subjects visit the study site for installation and removal of the device and accompanying exams, but remain ambulatory during the recording.


Eligibility Criteria:
Inclusion Criteria:

* Healthy subject without previous ocular disease
* Aged ≥ 18 years, of either sex
* Central corneal radius (flat meridian) between 7.75 mm and 8.25 mm in at least one eye
* Not more than 6 diopters spherical equivalent in the study eye
* Having given written informed consent, prior to any investigational procedures

Exclusion Criteria:

* Corneal or conjunctival abnormality precluding contact lens adaptation
* Severe dry eye syndrome
* Subjects with allergy to corneal anesthetic
* Subjects with contraindications for silicone contact lens wear
* Subjects not able to understand the character and individual consequences of the investigation
* Participation in other clinical research within the last 4 weeks
* Any other contra-indication listed in the TF user manual
A Study to Investigate Efficacy and Safety of VTAMA (Tapinarof) Cream, 1% in Intertriginous Plaque Psoriasis

This is an open-label, multi-center study to evaluate the efficacy and safety of VTAMA (tapinarof) cream, 1% in adults with intertriginous psoriasis

This is an open-label study in which participants will be assigned to receive VTAMA (tapinarof) cream, 1% once daily for 12 weeks. Study participants will have a follow-up period of 1 week. The study duration will be up to 17 weeks.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older, at the time of signing the informed consent
* Participants with clinical diagnosis of plaque psoriasis, including lesion(s) in intertriginous area(s) and stable disease in intertriginous areas for at least 3 months prior to the study
* An iPGA score of 2 (mild), 3 (moderate), or 4 (severe) at screening and baseline
* Female subjects of child bearing potential who are engaging in sexual activity that could lead to pregnancy agree to follow the specified contraceptive guidance throughout the study
* Negative pregnancy test at Baseline (Day 1)
* Capable of giving written informed consent

Exclusion Criteria:

* Diagnosis of a type of psoriasis other than plaque psoriasis
* Any sign of infection of any of the psoriatic lesions
* Concurrent significant dermatologic or inflammatory condition other than plaque psoriasis that, in the Investigator's opinion, would make it difficult to interpret data or assessments during the study
* History of or ongoing serious illness or medical, physical, or psychiatric condition(s) that, in the Investigator's opinion, may interfere with participation in the study and ability to understand and give informed consent
* History of sensitivity to the study product, or components thereof or a history of drug or other allergy that, in the opinion of the Investigator or Medical Monitor, contraindicates participation in the study
* Previous known participation in a clinical study with tapinarof (previously known as GSK2894512 and WBI-1001); previous or current use of VTAMA® (Tapinarof) Cream 1%
* Use of any prohibited medication or procedure within the indicated period before the baseline visit including other investigational product within 30 days or 5 half-lives of the investigational product (whichever is longer)
* UV light therapy or prolonged exposure to natural or artificial sources of UV radiation (e.g., phototherapy, tanning beds/booths, or therapeutic sunbathing) within 4 weeks prior to the Baseline
Neurophysiologic Maturation Index for Moderate and Late Preterm Infants

Moderate and late preterm infants contribute to significant neonatal intensive care unit health care resource utilization because of their sheer numbers. Determinants of the length of hospitalization (LOH) in this population are understudied. Gestational age (GA) is used most commonly as a predictor for LOH but there are many limitations including inaccurate dating and morbidities of prematurity which at least partly related to neurophysiological immaturity. The latter can be assessed by amplitude integrated electroencephalogram (aEEG, a simplified 5 lead EEG), and possibly by heart rate variability (HRV) and respiratory variability (RV). All 3 are non-invasive tests that can be done at the bedside. Our study hypothesis is to determine if neurophysiologic maturation as assessed by aEEG, HRV and RV within 24-96 hours following birth improves the correlation between gestational age and length of hospitalization compared to gestational age alone.


Eligibility Criteria:
Inclusion Criteria:

* Gestational age of either 320-326 weeks or 340-346 weeks by Obstetric criteria (presence of a sure LMP or sonogram performed in the first trimester, or agreement between LMP and a sonogram performed between the first trimester and 20 weeks)
* Admitted to a NICU of a participating institution
* Post-natal age less than 96 hours

Exclusion Criteria:

* Major congenital anomaly/genetic anomaly
* Growth restriction (birth weight \< 10%, Fenton growth curves)
* Unsure obstetric dating (e.g., absence of a sure LMP without a sonogram, earliest sonogram performed after 20 weeks without a sure LMP, or discrepancy between LMP and sonogram)
* Exposure to medications within the preceding 12 hrs which may affect CNS function (e.g., fentanyl, morphine, midazolam)
* Neonatal seizures
* Neonatal abstinence syndrome secondary to in-utero exposure to narcotics, methadone etc, or at high risk for development of abstinence
* Hypoxia-ischemia defined as the combination of fetal acidemia (cord gas or blood gas within 1 hour of birth: pH ≤ 7.15 or BE ≥ -10mEq/L), need for resuscitation at birth (PPV ± chest compressions or medications), and evidence of encephalopathy (Stage 1, 2 or 3 Sarnat). Stage 1 encephalopathy will be defined based on the level of consciousness which is characterized by a hyper-alert state, apparent alertness, and irritability. In the absence of a cord or early post-natal blood gas, there must be a history of a perinatal event which may have compromised oxygenation or blood flow to the fetus.
* Infants who are expected to be on mechanical (via an endotracheal tube) or high frequency ventilation for the first 96 hours after birth.
* Inability to obtain the informed consent
Surrogating Physician-recorded SCORE2 Risk Calculator Inputs by Using Auxiliary Data

The goal of the clinical trial is to assess whether the data collected from wearable devices can reduce the uncertainty in predicting the cardiovascular disease (CVD) risk in women aged 40-69 years in a situation where information about the blood pressure and blood lipids are unavailable.

Participants will:

* Complete a screening and baseline assessment, including blood sample collection and vital parameter measurement.
* Wear a wearable device for one week.
* Fill in a work and sleep journal.
* Complete a last visit assessment.


Eligibility Criteria:
Inclusion Criteria:

* Fluency in German (written and oral).
* Ownership of a smartphone.
* Signing the informed consent form.

Exclusion Criteria:

* Diagnosis of cardiovascular disease.
* Diagnosis of diabetes mellitus.
* Diagnosis of chronic kidney disease.
* Diagnosis of familial hypercholesterolemia.
* Incapable of providing informed consent.
* Current employment at the Section Gynecological Endocrinology and Reproductive Medicine of the Department for Obstetrics and Gynecology at the Inselspital Bern or any other professional relation to one of the study project leaders / investigators.
* Concurrent participation in a clinical intervention study.
* Inability to comply with the study procedures for any reason, including language comprehension, psychiatric illness, general inability to get to the study site.
* Participant's smartphone not compatible with Fitrockr.
* Technical inability of participant's smartphone to connect to the smartwatch.
ALERT-HF: Adherence to Guidelines in the Treatment of Patients With Chronic Heart Failure

ALERT-HF is an observational study aimed to evaluate the diagnostic criteria adopted and the adherence to the current therapeutic guidelines in a large series of patients affected with chronic heart failure. Secondary objective is to evaluate the prevalence of chronic heart failure among all the patients referring to the ambulatory cardiologists of the healthcare district.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Heart Failure
* Signature of informed consent
* Age older than 65 years

Exclusion Criteria:

* indication for cardiac surgery or cardiac surgery by less than 3 months
* age less than 65 years
* inability to perform periodic checks
* presence of malignant neoplasms and other severe diseases.
IL-7 Receptor Polymorphisms and Immune Recovery With HAART

The aim is to investigate the hypothesis that IL7-receptor polymorphisms contribute to the differential immune recovery of CD4 + T cells following HAART

AIM: To examine the association between the four haplotypes of IL-7Rα gene and a cohort of HIV infected patients who have commenced HAART with varying CD4+ T lymphocyte responses.

METHODS: IL-7Rα gene SNPs and haplotypes will be measured by constructing DNA pools, and PCR amplification and DNA sequencing. IL-7Rα expression will be examined using constitutive expression of IL-7Rα, IL-7Rα gene expression, and inducible expression of IL7Rα.

Eligibility Criteria:
Inclusion Criteria:

* Men or women at least 18 years of age
* First antiretroviral regimen composed of HAART as defined by at least three antiretrovirals
* Controlled viremia for a period of at least 12 months following commencement of HAART. Controlled viremia is defined as HIV viral load of ≤ 500 copies/mL on bDNA testing (versions 2 and 3) and \<400 copies/ml measured by RT-PCR assay by 6 months treatment.
* CD4 cell count \<500 at commencement of HAART
* Measurement of CD4+ cell count on at least 3 time points, in the 12 months post commencement of HAART.

Exclusion Criteria:

* Exclude patients treated for HIV seroconversion illness
* Exclude patients on immunomodulatory therapy such as IL-2, hydroxyurea or prednisolone or who have received an HIV therapeutic vaccine
Changes in Pelvic Health, Sexual Function, and Quality of Life in Women With Pelvic Cancer Undergoing Radiation Therapy

This study investigates changes in physical measures of pelvic health and patient-reported outcomes of sexual function, intimate relationship, and quality of life over time in women undergoing radiation therapy for pelvic cancer. Evaluating vaginal changes prior to and after a course of radiation and collecting patient reported outcomes of sexual function, partner communication, and intimacy may help researchers may help researchers better understand physical changes and symptoms over time.

PRIMARY OBJECTIVES:

I. To evaluate changes in objective physical exam findings from baseline to the end of radiation and through two years follow-up for women with pelvic cancer.

II. To examine changes in sexual, relational and quality of life outcomes from baseline to the end of radiation and through one year follow-up for women with pelvic cancer using the patient reported outcome measures.

III. To compare physical exam and patient-reported outcome trajectories over time.

OUTLINE:

Patients undergo standard of care pelvic exam at baseline and 1, 3, 6, 12, and 24 month follow ups. Patients also complete patient reported outcome measures at baseline and 1, 3, 6, 12, 18, and 12 month follow ups.

Eligibility Criteria:
Inclusion Criteria:

* Any patient with anal, rectal, cervical, endometrial, vaginal, or vulvar cancer receiving external beam radiation alone, brachytherapy alone, or both external beam radiation and brachytherapy
* Concurrent or prior chemotherapy is allowed, including those participating in Ohio State University (OSU)-16166
* Any prior gynecologic surgery is permitted
* Rectal surgery, including lower anterior resection and abdominoperineal resection, is permitted

Exclusion Criteria:

* Patients with scleroderma, mixed connective tissue disorder, and lupus will be excluded
* Patients who have received prior pelvic radiation
Serum Concentration of Endogenous Estrogens and Sirtuin-1 After Administration of Atorvastatin and Quercetin:

Chronic coronary syndrome (CCS) is the leading cause of death in women in the most developed regions of Brazil. The primary etiopathogenic mechanism is the process of atherosclerosis. A healthy diet rich in fruits and vegetables is associated with a lower incidence of CCS. The higher consumption of these foods promotes greater availability of phenolic compounds, and the higher intake of these compounds is one of the main hypotheses for vascular health. Quercetin, a phenolic compound, is the most abundant natural antioxidant belonging to the group of flavonoids. Quercetin improves lipoprotein metabolism, has an antioxidant capacity, produces vasodilating substances in the vascular endothelium, and reduces platelet aggregability. Likewise, statins are medications known to reduce cardiovascular events in women with CCS by reducing serum LDL-cholesterol levels and, to a lesser extent, by possible pleiotropic effects. In turn, SIRT1 is one of the 7 classes of proteins. It mediates various metabolic pathways in response to nutritional stimuli, particularly for caloric restriction and phenolic compounds, as well as coordinating the production and secretion of important hormones. However, the impact of quercetin supplementation and statin administration on serum endogenous estrogen levels is unknown

The main objective of this study is to investigate the influence of atorvastatin and of quercetin in the serum concentrations of estradiol and estrone after the administration of atorvastatin and supplementation with quercetin. This is a randomized, double-blind, placebo-controlled, 60-day study in 60 postmenopausal women with CAD, divided into three groups of 20 women each: Group 1 - quercetin (500 mg/day); Group 2 - atorvastatin (80 mg/day); Group 3 - control (placebo).

Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women;
* Diagnosed coronary artery disease;
* Stable coronary disease;

Exclusion Criteria:

* hypo or hyperthyroidism,
* rheumatic disease,
* use of alcohol,
* hepatic failure,
* renal failure
* hormone replacement therapy
* use of insulin