cyrilzakka/clinical-trials huggingface dataset:
Behavioral Science and Hepatitis C Screening Outreach

This project aims to evaluate different approaches to increase Hepatitis C screening among primary care patients at Penn Medicine through a centralized screening outreach program. In a pragmatic trial, we will evaluate different approaches to increase completion of screening among eligible patients, including changing the default from opt-in to opt-out and incorporating behavioral science principles into the outreach communication.

The hepatitis C virus (HCV) is the leading cause of liver transplant and hepatocellular carcinoma in the US. New direct-acting antivirals are available that can eradicate the disease in over 95% of those that are treated, with minimal side effects. As a result of new therapies and a five-fold higher risk among baby boomers, the US Preventive Services Task Force and CDC now recommend HCV screening for all patients born between 1945 and 1965. Of the estimated 3.2 million people chronically infected with HCV, about 75% were born during this time frame. Despite this, national rates of screening among this group remain low at less than 30%. If more people could get screened, we could potentially identify more undiagnosed disease and help navigate to treatment.

At Penn Medicine primary care practices, HCV screening rates have risen from 37% in 2014 to 61% in 2017, likely from a combination of provider educational efforts and EHR alerts. There is also significant practice variation ranging from 4% to 99% screening rates. While EHR alerts have been shown to increase HCV screening rates, there is potential to complement this with direct outreach to patients homes, as has been incorporated into cancer screening initiatives. Additionally, there is a mandate from the state of Pennsylvania requiring health care providers to offer HCV testing to all primary care patients. There is an opportunity to provide direct outreach to all eligible primary care patients at Penn Medicine, while also evaluating different approaches to increasing HCV screening rates.

Insights from behavioral science have been shown to increase participation in health promoting behaviors in a variety of ways. Switching from opt-in to opt-out framing has been shown to triple patient participation in remote monitoring and CRC screening. Additionally, messaging that incorporates social norms, reciprocity, and precommitment have also been shown to increase participation. However, it is not clear how these approaches would translate to HCV screening.

Eligibility Criteria:
Inclusion Criteria:

* at least 2 visits to primary care provider within 2 years
* born between 1945 and 1965

Exclusion Criteria:

* have had 1 HCV antibody test, viral load test or are considered up-to-date on HCV screening by health maintenance
Social Connections and Late Life Suicide

With the long-term goal of improving interventions for late-life suicide, the purpose of this study is to examine whether a mechanism by which behavioral interventions reduce risk for late-life suicide is by increasing social connectedness. The investigators propose to examine whether a manualized intervention that targets connectedness--ENGAGE--increases connectedness in older adults who report clinically significant depression and disconnectedness-operationalized as feeling lonely and/or like a burden on others. The investigators propose a randomized controlled trial comparing the ENGAGE intervention with care-as-usual (CAU), using n=100 primary care patients aged ≥ 60 years who report social disconnectedness (i.e., loneliness or burdensomeness) and either Minor or Major Depression. At baseline, 3-week, 6-week and 10-week assessments, subjects will report on social connectedness, depression, and suicide risk. The investigators hypothesize that those subjects assigned to ENGAGE will report greater increases in connectedness-measured as greater belongingness and lower burdensomeness-compared to CAU; that ENGAGE will produce greater reductions in depression and suicide ideation than CAU; and that changes in depression will be accounted for changes in social connectedness.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 60 yrs;
* English speaking;
* Reside in the community;
* Endorse social disconnectedness, as measured by feeling lonely and/or like a burden on others;
* Meet criteria for Minor or Major Depression.

Exclusion Criteria:

* Imminent risk for suicide;
* Active psychosis;
* Significantly impaired cognitive functioning (i.e., MOCA \<23);
* Active substance abuse in the last year (AUDIT score of 5 or more);
* Hearing loss that precludes comfortable communication;
* Residence in a long-term care facility.
The Effect of Virtual Reality Application on Pain Severity, Anxiety Level and Patient Satisfaction

In this study; It is aimed to examine the Effect of Virtual Reality Based Relaxation Program on Pain Severity, Anxiety Level and Patient Satisfaction in Patients Who Will Be Applied Angiography.

Beginning 1 minute before the start of the procedure, the patients will be watched (30-45 minutes) with an android mobile phone inserted into the Cardboard Super Flex Binoculars Glasses, with a music background, licensed product "Secret Garden", during the procedure (30-45 minutes).

Eligibility Criteria:
Inclusion Criteria:

* Being over 18 years old
* Ability to communicate adequately
* Absence of psychiatric problems
* Volunteering to participate in the research
* Experiencing coronary angiography for the first time

Exclusion Criteria:

* Those who have communication problems
* Those with psychiatric problems
* Emergency coronary angiography
* Having symptoms of myocardial infarction,
* Being unconscious,
* Having surgery in the last 6 weeks,
A Clinical Study to Evaluate the Safety and Efficacy of Mesenchymal Stem Cells in Liver Cirrhosis

Cirrhosis is caused by sustained liver damage over several years either by alcohol, viral infection (Hepatitis B, C), a toxic substance (for eg. drugs, excess copper or iron in the liver), or by blockage of biliary system such that the liver undergoes progressive scarring that slowly replaces all of normal liver cells.(LC) represents a late stage of progressive hepatic fibrosis characterized by distortion of the hepatic architecture and formation of regenerative nodules. For this condition of disease the liver transplantation is one of the only effective therapies available ,but due to lack of donors, surgical complications, rejection, and high cost are it's serious problems.

Presently stem cells are used to be a one of the treatment for the same. So our approach is to evaluate the safety and efficacy of mesenchymal stem cell in condition of liver cirrhosis .

In this study, the patients with liver cirrhosis will undergo administration of human Mesenchymal stem cell MSCs intravenously for these patients.To observe the results Liver function will be monitored by serum analysis.The levels of serum alanine aminotransferase (ALT), total bilirubin (TB), prothrombin time (PT), prealbumin(PA) and albumin (ALB) will be examined at pre-transfusion, and 6th days to 1 years post-transfusion.Also the to see Improvement evaluation by MELD score ,Quality of life ,Child-Pugh score will be done .

Eligibility Criteria:
Inclusion Criteria

* 25 -65 Ages Eligible for Study
* Clinical diagnosis of liver cirrhosis
* Ability to comprehend the explained protocol and thereafter give an informed consent as well as sign the required Informed Consent Form (ICF) for the study.
* Expecting lifetime is over three years
* Ready to come all visits

Exclusion Criteria:

* History of life threatening allergic or immune-mediated reaction
* Positive test results for HIV and AIDS complex ,HCV , HbsAg and Syphilis
* Malignancies
* Sepsis
* Vital organs failure
* Pregnant or lactating women
* Subject who has been transplanted recently
* If the investigator or treating physician feels that the Subject with any disease or condition would interfere with the trial or the safety of patient
Development and Evaluation of the T.E.A.C.H. Study: A Randomized Control Trial

Using a randomized control design, this study seeks to develop and evaluate a nutrition intervention to increase Montessori teachers' nutrition knowledge, nutrition self-efficacy, nutrition teaching self-efficacy and cultural food competence to improve teachers' eating behaviors, nutrition teaching practices, classroom food practices, and teacher-parent communication. This study will examine the feasibility and efficacy of a nutrition intervention for teachers which will include a nutrition education program via an online platform and hands-on Montessori-based curriculum to teach nutrition in the classroom. Teachers from multiple schools will be recruited using the public national Montessori listserv. This study will enhance teachers' nutrition knowledge which may increase their nutrition teaching practices and improve their personal nutrition habits. Improving teachers' personal and classroom nutrition practices may improve teachers' personal health outcomes and may positively impact their students through modeling of healthy behaviors and improving the classroom food environment.


Eligibility Criteria:
Inclusion Criteria:

Teachers were considered eligible to participate in the study if they taught in early childhood classrooms (students 3 to 6 years old), were ≥ 18 years old, and had access to an electronic device with internet connection and audiovisual capabilities.

Exclusion Criteria:

Teachers were deemed ineligible to participate if they were not fluent in English (written \& verbal) or had plans to leave their place of employment during the study timeframe
Extracorporal Shockwave Lithotripsy Versus Retrograde Intrarenal Surgery for the Treatment of Kidney Stones

The purpose of this study is to compare two established modalities for the treatment of kidneystones: ESWL (extracorporal shockwave-lithotripsy) vs. URS (uretero-reno-scopy with stone-extraction). Comparison of the stone-free rates 3month postoperative.

* Trial with surgical intervention


Eligibility Criteria:
Inclusion criteria: - kidneystones requiring treatment up to an maximal size of 15mm (singular or multiple kidneystones with at least one stone with min. 5mm of size)

* male and female patients between 18 and 99 years
* informed consent signed by patient after explanation of the both treatment-modalities

Exclusion criteria: - age \< 18 or \> 99

* pregnancy
* breastfeeding mother
* disorders of blood clotting
* kidneystones \> 15mm
* aneurysms of the aorta or renal artery
* severe skeletal deformations which hamper one of the treatment modalities
* synchronous stones of the ipsilateral ureter
* stones which can not visualized which X-ray or sonography
Right Ventricular Resynchronization Therapy

The purpose of this study is to determine whether cardiac resynchronization therapy with the use of an implanted electronic pacemaker reduces morbidity associated with chronic thromboembolic pulmonary hypertension

Rationale: The clinical severity of right ventricular disease is largely determined by right-to-left ventricular dyssynchrony, i.e., delay of electrical activity between the right and left ventricles. Moreover, in patients with chronic thromboembolic pulmonary hypertension (CTEPH), we found that acute correction of this dyssynchrony by temporary pacing (prior to pulmonary endarterectomy, presently the therapy of choice for CTEPH) results in significant improvement in cardiac output. In this study, we aim to establish whether chronic pacing with the use of implanted pacemakers confers long-lasting improvements in cardiac output and functional class.

Objective: To study whether chronic pacing with implanted pacemakers confers long-lasting improvements in cardiac output and functional class in severely symptomatic CTEPH patients who are not eligible for pulmonary endarterectomy, or those in whom pulmonary endarterectomy has failed.

Study design: Chronic intervention study, double-blinded, randomized, cross-over.

Study population: Adult CTEPH patients who are not eligible for pulmonary endarterectomy, or those in whom pulmonary endarterectomy has failed.

Intervention (if applicable): chronic right ventricular resynchronization therapy (RVRT), i.e., chronic right atrial, right ventricular, and left ventricular pacing with the use of implanted pacemakers.

Main study parameters/endpoints: (Duration of) improvements (in l/min) in cardiac output as measured using Doppler echocardiography, and functional class as measured using 6-minute walking distance (6-MWD), right and left ventricular dimensions and ejection fractions (99mTechnetium scintigraphy), biomarkers for heart failure (serum NT-proBNP levels), and quality of life (SF-36) questionnaire.

Design: Randomized, double-blind, cross-over study with 2 arms of 10 patients each (arms 1 and 2). In arm 1, RVRT is switched on immediately after pacemaker implant, is switched of in week 5, and switched on at the start of week 6 until study end (32 weeks). In arm 2, RVRT is switched at the start of week 5 after pacemaker implant until study end (32 weeks). At various follow-up visits at weeks 1, 4, 5, 6, 8, 12, 16, the main study parameters/endpoints (see previous paragraph) will be assessed.

Eligibility Criteria:
Inclusion Criteria:

Adult patients with chronic thromboembolic pulmonary hypertension (CTEPH) who are ineligible for pulmonary endarterectomy, and those in whom pulmonary endarterectomy has failed

Exclusion Criteria:

None
Patient-Reported Outcomes and Quality of Life in Adult and Pediatric Patients With Nodular Lymphocyte-Predominant Hodgkin Lymphoma (NLPHL)

There is a pressing need to measure patient-reported symptoms in patients of all ages diagnosed with nodular lymphocyte-predominant Hodgkin lymphoma (NLPHL). This study aims to measure longitudinal symptom burden and treatment tolerability utilizing validated patient-reported outcomes (PROs) instruments.

Primary Objective:

* To develop the data collection infrastructure required to prospectively collect longitudinal electronic patient-reported outcomes (PROs) survey instruments in adult and pediatric patients diagnosed with NLPHL.

Secondary Objective:

* To examine differences in baseline and longitudinal changes in PROs based on disease characteristics, disease status, and treatment strategies among adult and pediatric patients diagnosed with NLPHL.

The broad aim of this study is to develop the foundational data management infrastructure required to prospectively collect longitudinal electronic patient-reported outcomes (PROs) survey instruments in adult and pediatric patients diagnosed with nodular lymphocyte-predominant Hodgkin lymphoma (NLPHL). The study team further aims to elucidate how PROs change over time and how they may be affected by different patient, disease, and treatment characteristics.

Eligibility Criteria:
Inclusion Criteria

* Age ≥ 8 years
* Patient or their adult proxy must have verbal and written English language proficiency.
* Pathologically confirmed diagnosis of nodular lymphocyte-predominant Hodgkin lymphoma (NLPHL); patients with evidence of transformed lymphoma at diagnosis or subsequent development of transformed lymphoma after diagnosis are eligible.
* Patients or their adult proxy must be able to provide consent.
* Patients and/or adult proxy must be able to complete electronic quality of life surveys

Exclusion Criteria

* Age 7 years or less.
* Patient or adult proxy does not have verbal and written English language proficiency.
* Patients with histologic evidence of a composite lymphoma (NLPHL with a concurrent diagnosis of Hodgkin lymphoma, indolent non-Hodgkin lymphoma, or gray zone lymphoma) at diagnosis are not eligible.
* Inability or unwillingness of research participant or legal guardian/representative to give consent.
Adherence to Guidelines VAccination in Type 1 DIabetes Mellitus Patients (AVADI-1).

Observational study about adherence to guidelines for Influenza, Pneumococcal and Hepatitis B Vaccination in adult patients with type 1 Diabetes mellitus.

Cross-sectional analysis about adherence to guidelines for Influenza, Pneumococcal and Hepatitis B Vaccination in adult patients with type 1 Diabetes mellitus.

All clinical variables are gathered from two EMR softwares (Mambrino XXI and Turriano).

Data analysis is conducted using SPSS (Chicago, IL) statistics software. Results are presented as mean ± SD values or percentages. A paired Student's t-test or a Wilcoxon signed-rank test were used for the analysis of differences. Comparisons between proportions were analyzed using a chi-squared test. A P value \< 0.05 was considered statistically significant.

The protocol was approved by the reference Castilla-La Mancha Public Health Institute Ethic Committee. All participants provided written informed consent.

Eligibility Criteria:
Inclusion Criteria:

* ≥18 years of age.
* Diagnosed of Type 1 Diabetes Mellitus.
* Be attended in Ciudad Real General University Hospital.

Exclusion Criteria:

* Less than 18 years old.
* Other types of diabetes mellitus.
Survivorship Sleep Program

This is a randomized pilot trial to test the feasibility and acceptability (primary outcomes) of a virtual cognitive behavioral program for insomnia for survivors of various cancer types. Secondary outcomes are to examine the preliminary effects on reducing insomnia severity from baseline to post-intervention.

Cognitive Behavioral Therapy for insomnia (CBT-I), is an evidenced-based insomnia program that is recommended by the American College of Physicians and can be delivered using session-by-session treatment manuals.

Among cancer survivors, CBT-I has only yielded small-to-moderate sized improvements in several aspects of sleep, including sleep efficiency, sleep onset latency, and wake after sleep onset as compared with inactive control conditions. Moreover, systematic reviews of CBT-I with cancer survivors have found high rates of attrition and low attendance. Thus, while CBT-I for cancer survivors is promising, further adaptation is needed to demonstrate greater feasibility and larger effects. Additionally, CBT-I is traditionally delivered in-person, which is not feasible for many cancer survivors. Barriers include time limitations, travel, and illness burden constraints, as well as a paucity of trained CBT-I providers. Telehealth delivery of CBT-I is an innovative approach to address these barriers to care and enhance uptake.

The intervention being tested in this study was informed by a 4-10 session CBT-I protocol and adapted based on interviews the investigators conducted with cancer survivors with insomnia to learn about their sleep-related challenges, suggestions, and preferences for intervention delivery, as well as a systematic review and meta-analysis the investigators published in Sleep Medicine Reviews in 2020.

The research study procedures include screening for eligibility and randomization into 1 of 2 study arms: the Adapted Virtual Intervention Group or a Control Group (Enhanced Usual Care; referral for behavioral sleep medicine and sleep hygiene handout). Participants will be in this research study for approximately 2 months. It is expected that about 40 people will take part in this research study.

Eligibility Criteria:
Inclusion Criteria:

* History of nonmetastatic, localized, or regional solid or blood malignancy(ies)
* Completion of primary cancer treatment (i.e., radiation, surgery, and/or chemotherapy)
* Chronic insomnia
* Age ≥18 years

Exclusion Criteria:

* Self-reported inability to speak and write in English
* Undertreated noninsomnia sleep disorder (e.g., sleep apnea)
* Undertreated epilepsy, serious mental illness, or suicidality, and/or psychiatric hospitalization in the past year
* Unwilling or unable to discontinue night shift work
Rehabilitation After Coronary Bypass Grafting. Comparison of Different Types of Rehabilitation Programs

The purpose of this study is to compare different types of rehabilitation after coronary bypass surgery. The investigators wish to compare rehabilitation in an institution for four weeks with a home based rehabilitation. They also wish to compare rehabilitation in an institution for four weeks with a rehabilitation program were the patients live at home but visit the hospital twice a week for twelve week. The investigators will measure the patients' physical capacity by measuring their maximal oxygen consumption. The investigators will also analyze their blood and their endothelian function (how well their arteries dilate).


Eligibility Criteria:
Inclusion Criteria:

* Coronary artery bypass

Exclusion Criteria:

* Significant lung disease
* Drug abuse
* Pregnancy
* Major physical impairment
S0916, MLN1202 in Treating Patients With Bone Metastases

RATIONALE: Monoclonal antibodies, such MLN1202, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them.

PURPOSE: This phase II trial is studying how well MLN1202 works in treating patients with bone metastases.

OBJECTIVES:

Primary

* To assess the urinary n-telopeptide (uNTX) response to anti-CCR2 monoclonal antibody MLN1202 in patients with bone metastases.

Secondary

* To assess the feasibility of performing cross-disease site trials within the Southwest Oncology Group.
* To explore the effect of anti-CCR2 monoclonal antibody MLN1202 on markers of tumor cell proliferation, monocytes/macrophage trafficking, and osteoclast maturation.
* To estimate allele frequencies of defined SNPs occurring in the CCL2 and CCR2 genes in these patients.

OUTLINE: This is a multicenter study.

Patients receive anti-CCR2 monoclonal antibody MLN1202 IV over 1 hour on days 1, 15, and 29 in the absence of disease progression or unacceptable toxicity.

Patients undergo urine and blood sample collection at baseline and on days 15, 29, and 43 for correlative biomarker and polymorphism studies.

After completion of study treatment, patients are followed up for ≥ 30 days.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Radiographically documented metastases to the bone by bone scan, x-ray, CT scan, MRI, or PET scan within the past 42 days

  * Documentation of progression of metastatic disease by serial scans is not required for study entry
* No untreated or progressive brain metastases

  * History of brain metastases allowed provided they have been treated and remain controlled

PATIENT CHARACTERISTICS:

* Zubrod performance status 0-2
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Must consent to urine and blood specimen submissions
* No concurrent uncontrolled illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situation that would limit compliance with the study requirements
* No known hypersensitivity to anti-CCR2 monoclonal antibody MLN1202 or other recombinant human antibodies

PRIOR CONCURRENT THERAPY:

* At least 14 days since prior radiotherapy and recovered (≤ grade 1 from all related toxicities)
* At least 84 days since prior radionuclide therapy (e.g., strontium, samarium) and recovered (≤ grade 1 from all related toxicities)
* More than 14 days since prior investigational agents, chemotherapeutic agents, or other anticancer agents
* Concurrent bisphosphonate therapy for bone metastases allowed provided treatment was initiated ≥ 28 days before study entry

  * No initiation of bisphosphonates during study treatment
* Concurrent hormonal therapy (e.g., anti-estrogens or anti-androgens) or stable doses of steroids for cancer allowed provided treatment was initiated \> 14 days before study entry
* No concurrent G-CSF or other growth factor support