cyrilzakka/clinical-trials huggingface dataset:
Improving Palliative Care Access Through Technology

This project will focus on developing, optimizing and pilot-testing a multi-component Improving Access Through Technology (ImPAcTT) intervention that leverages existing telehealth technologies to provide staff education; family outreach, engagement and support; care coordination; and resident symptom management and facilitation of goals-of-care discussion.

Almost 1.8 million older Americans live in nursing homes (NH), with estimates that this number will grow to more than 3 million by 2050. NHs are increasingly becoming the place of care and site of death for frail older adults dying from multiple chronic illnesses. Unfortunately, most residents die without the benefit of palliative care (PC) or with palliation delayed until the last days of life.

Unfortunately, hospice services are often the only formal end of life care service available in NHs, and access to hospice enrollment is complicated by financial implications for both NHs and residents.

Telehealth, or remote monitoring of patients through information and communication technologies, is an effective mechanism for addressing the increased demand on health services and has much to offer to people living with and dying from advanced illness. Moreover, numerous studies have demonstrated positive benefits of using telehealth in the NH to improve access to consultants (e.g., neurology, dermatology, psychiatry).

Little is known, however, about the effect of using Telehealth on improving access to PC specialists in the NH setting.

The proposed ImPAcTT intervention employs a secure communications platform that permits multi-person live video, audio, and text message consultations; real-time document sharing and documentation for advanced care planning discussions; and remote virtual assessment capabilities.

The investigator will conduct a pilot implementation trial of ImPAcTT in 3 study nursing homes to evaluate our ability to safely recruit and retain study participants, collect appropriate and accurate data, and determine preliminary estimates of an effect size of the intervention.

Eligibility Criteria:
Purposeful sampling will take place in an attempt to collect data from a range of ethnically and racially diverse participants.

INCLUSION CRITERIA:

Primary participant

* Age \>= 18 years
* English language fluency
* Palliative Care Consult Screening Tool (PCCS) scoring 9 or above
* If participant does not demonstrate capacity to consent, he/she must be able to assent to study procedures, be told of plan to approach surrogate and have a legally authorized representative available to provide consent

Family/friend caregivers:

* Closest relative/next of kin/friend who is involved in the care of his/her loved one before and during the study period
* English fluency

EXCLUSION CRITERIA:

Primary participant:

* Enrolled in hospice
* Unable to assent to study procedures
* Expresses resistance or dissent to participation or the use of surrogate consent

Family/friend caregiver:

* Life expectancy \< 1 year (e.g., metastatic cancer)
* Evidence of cognitive impairment or inability to consent to study procedures
Continuation Study of Entinostat in Combination With Pembrolizumab in Patients With Advanced Solid Tumors

The objectives of this study are to explore different dosing levels and schedules of entinostat in combination with pembrolizumab in patients with advanced solid tumors, in terms of safety, tolerability, pharmacokinetics (PK), impact on immune correlatives, and efficacy

This is a Phase 1, open-label, single center, randomized study to assess the safety and tolerability of 3 different dose regimens of entinostat in combination with pembrolizumab in patients with advanced solid tumors who previously completed Study SNDX-275-0140 (NCT02897778). Up to 30 patients will be randomized in a 1:1:1 fashion to one of three arms. In the event that greater than or equal to 2 out of the first 6 patients randomized experience a dose-limiting toxicity, the next patient randomized to that Arm will receive treatment at a reduced starting dose as outlined in the protocol.

Eligibility Criteria:
Inclusion Criteria:

1. Completed Study SNDX-275-0140 (NCT02897778)
2. Any AE or toxicity experienced in Study SNDX-275-0140 (NCT02897778) is resolved to less than or equal to Grade 1
3. Continues to meet inclusion criteria for Study SNDX-275-0140 (NCT02897778) at the time of entry into this study

Exclusion Criteria:

1. Completed Study SNDX-275-0140 (NCT02897778) more than 30 days prior to Cycle 1 Day 1 of this study
2. Continues to meet exclusion criteria for Study SNDX-275-0140 (NCT02897778) at the time of entry into this study
Comparison of the New Fitting Method Cochlear Nucleus Fitting Software (NFS) With the Established Fitting Method Cochlear Nucleus Custom SoundTM Suite (CSS)

The purpose of this study is to evaluate if the new and simplified fitting method with Cochlear Nucleus Fitting Software (a major component of a suite of tools which form the Clinical Care Innovation) provides Cochlear Implants Recipients with the same hearing outcome as the current and established clinical fitting method with Cochlear Nucleus Custom SoundTM Suite. The Clinical Care Innovation method reduces fitting to simple volume, bass and trebles adjustments, operations which are familiar to anyone who has used an audio player.


Eligibility Criteria:
Inclusion Criteria:

* Newly implanted subjects with available Nucleus Cochlear Implants compatible with CP900 series sound processors (excluding Cochlear Nucleus Hybrid)
* Post linguistically deafened adults (≥ 18 years)
* Unilaterally implanted
* ≤ 15 years of severe to profound deafness prior to implantation
* Subjects who are capable and willing to participate in speech perception tests in local language
* Subjects who are able to provide feedback in form of a written questionnaire (e.g. Speech Spatial Hearing Qualities questionnaire)
* Subjects willing to give their consent to the study

Exclusion Criteria:

* Additional handicaps that would prevent participation in evaluations (e.g. visual impairment, blindness)
* Unrealistic expectations on the part of the subject, regarding the possible benefits, risks and limitations that are inherent to the procedure/fitting method
* Bilateral implantation
* Hybrid-L (not supported by Nucleus Fitting Software)
* Subjects who already have hearing experience with a Cochlear Implant (e.g. reimplantation, contralateral Cochlear Implant)
* Subjects with single-sided deafness
* Known cochlea malformations
* Subjects who lost their hearing due to meningitis
Speckle Tracking in Pediatric Patients

An echocardiogram, also called a cardiac ultrasound or echo, is a medical test that takes pictures of the heart using sound waves. It shows images of the structures of the heart without using radiation. During the last year, the FDA has approved a new technology called Speckle Tracking that can look at the heart wall motion and contraction (pumping or squeezing) abnormalities. The study will also employ tissue Doppler and 3-Dimensional echo and uses the same echocardiographic machines which are used right now. The machines are upgraded with the new software application. This new technology is currently being used in adults, but unfortunately, there is almost no published data about normal heart function in infants and children using this technology. It is known from other technologies that the developing child's heart is not the same as an adult.

The investigators wish to study this new technology and compare it to other technologies currently being used.

This study will be done primarily by software analysis.

The investigators wish to enroll a total of 70 patients aged newborn to 17 years old. The patients will be divided into three groups: (1) 0-2 years (2) 2-10 years (3) 10-17 years of age. 59 of the patients will be normal volunteers - siblings of patients receiving routine echoes or siblings of patient caregivers at Children's Healthcare of Atlanta. The investigators will age-match those patients with twenty patients with known or suspected heart muscle dysfunction (not working properly) already scheduled for a routine echo. For the patients scheduled for a routine echo, the patient and parent/guardian will be approached prior to the routine echo being performed. If they consent/assent, it will take an additional 10-15 minutes to obtain the research images after their routine images have been obtained. The healthy volunteers will be screened from the siblings of the patients receiving a routine echo or from siblings of patient caregivers, the study explained and informed consent/assent obtained. It will take approximately 30 minutes to obtain the research images.

By studying this new technology, the investigators will be able to find out whether it will be able to give us useful information on how the heart muscle contracts, the coordination of these contractions and if it may indicate new areas for treatment.

Eligibility Criteria:
Inclusion Criteria:

Healthy Volunteers

* No known heart disease
* Age of birth to 17 years.
* Patients will be compared to age appropriate controls.
* Stable clinical condition
* Able and willing to sign informed assent (where appropriate) and consent

Study Group

* Suspected or known heart muscle dysfunction or cardiomyopathy.
* Age of birth to 17 years
* Stable clinical condition
* Able and willing to sign informed assent (where appropriate) and consent

Exclusion Criteria:

* Patients who do not have structurally normal left ventricles, have unstable or irregular heart rhythms.
* Patients not in stable clinical condition
* Unable or unwilling to sign informed consent and/or assent.
Prevention of Parastomal Hernias With a Preformed Three-dimensional, Funnel-shaped Mesh

Parastomal hernia (PH) remains a significant complication following stoma creation, boasting a considerable prevalence in the range of 30 to 50% within the first year post-surgery, a figure that climbs even higher when considering radiological evidence irrespective of clinical symptoms. A noteworthy one-third of these cases necessitate subsequent surgical interventions, yielding suboptimal outcomes both in the short and long term. The clinical manifestations of PH are diverse, ranging from mild inconveniences like fecal leakage and dermatitis to more severe and potentially life-threatening complications such as intestinal obstruction, hernia incarceration, and ischemia.

Various systematic reviews and meta-analyses have advocated for the adoption of prophylactic meshes, although defining precise incidence and recurrence rates has proven challenging due to methodological disparities across studies. Keyhole and modified Sugarbaker techniques dominate laparoscopic and robotic approaches, yet none offer ideal outcomes.

The aim of this study is to evaluate the decrease of postoperative parastomal hernia using this three-dimensional, funnel-shaped mesh.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing a definitive colostomy confection
* Terminal colostomy confection
* ASA index III or inferior
* Patients who have given legat authorization to participate in the study

Exclusion Criteria:

* Lateral colostomy or a colostomy that will be removed posteriorly
Fixed Dose Triple Therapy in Severe Chronic Obstructive Pulmonary Disease in a Real World Setting

The rationale for this non-interventional study in confirmed moderate to severe chronic obstructive pulmonary disease patients aged 40 years and above, is to assess real-life effectiveness and safety of Trimbow® in clinical practice, and to bridge the gap with the existing clinical data.

This non-interventional study assesses the real-life effectiveness and safety of the fixed triple therapy Trimbow® compared to free triple therapy, considering patient individual data, in clinical practice at second and thirdline centres in patients with confirmed moderate to severe chronic obstructive pulmonary disease.

This is an hypothesis generating study. No formal primary endpoint is defined; parameters are evaluated in an exploratory or descriptive manner.

Eligibility Criteria:
Inclusion Criteria:

* Patient has provided written informed consent
* Patient is aged 40 years or older at time of initiation of Trimbow® treatment
* Patient is diagnosed with moderate or severe chronic obstructive pulmonary disease confirmed by spirometry (post-bronchodilation) based on the Global Initiative for chronic obstructive lung disease (GOLD) 2018 classification
* Patient treated with double inhalation or free triple therapy (using at least 2 devices) who are prescribed Trimbow®

Exclusion Criteria:

• Hypersensitivity to the active substances or to any of the excipients listed below:

* Ethanol anhydrous
* Hydrochloric acid
* Norflurane (propellant)
Multimodality Evaluation of Left Ventricular Remodeling In Mitral Regurgitation: A Pilot Study

The purpose of this research is to determine the feasibility of a larger, future study proposing a multimodal approach using cardiac CT and MRI to assess the risk of developing left ventricular (LV) systolic dysfunction in patients with mitral regurgitation (MR).


Eligibility Criteria:
Inclusion Criteria:

* Age \>= 18
* Male or Female
* A diagnosis of severe chronic primary mitral regurgitation
* Undergoing isolated robotic mitral annuloplasty at Mayo Clinic Rochester
* Patients must have the ability to consent or have an appropriate representative available to do so.

Exclusion Criteria:

* Prior valve intervention,
* Concomitant valve surgery at the time of mitral annuloplasty (e.g. tricuspid annuloplasty, aortic valve replacement).
* Concomitant \>= moderate regurgitation or stenosis in any other valve by preoperative echocardiography
* History of prior myocardial infarction
* History of cardiomyopathy unrelated to mitral regurgitation (e.g. dilated, hypertrophic, infiltrative)
* Pregnancy. Women of childbearing potential will be verbally screened by clinical staff during as part of routine pre-MRI evaluation. If a subject is unsure whether they could be pregnant, a negative pregnancy test will be performed prior to scanning.
* Implantable devices that would be a contraindication to MRI
* Severe allergy to gadolinium MRI contrast
African Cancer Genome: GMD

The goal of this study is to develop a comprehensive characterization of genetic and molecular drivers of breast and prostate cancer in individuals of African ancestry. The study is conducted by the African Caribbean Cancer Consortium (AC3) and involves the recruitment of patients from nine international AC3 research sites in the Bahamas, Barbados, Benin, Burkina Faso, Haiti, Jamaica, Kenya, Namibia, and Trinidad and Tobago, and the US. The main questions are to: molecularly characterize genomic changes in the African Cancer genomes of the breast and prostate and identify the effects of social determinants of health and lifestyle factors on mutational landscape. Black individuals that have been diagnosed with pathologically confirmed prostate or breast cancer will be included. Detailed social determinants of health survey, blood and archived FFPE tissues will be collected. (Tier 1) All patient tissues will be subject to IHC for receptor status (ER, AR, PR Her2/neu). All patients with available germline DNA from blood will receive genetic screening using a Commercial gene panel testing. (Tier 2) Patient samples with a negative genetic screening will be subject to whole exome sequencing or banked for later RNA or methylation sequencing.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients, 18-85 years of age, diagnosed with a pathologically confirmed cancer at any stage at diagnosis. Participant can have a history of a previous cancer we will control for previous history of cancer diagnosis in our analysis.

Exclusion Criteria:

* Patients age \<18 year, incarcerated patients, and patients whose medical decisions are made by proxy will be excluded.
CT-validation of Ultrasound Based Planning for High Dose Rate (HDR) Prostate Brachytherapy Using Vitesse

High Dose Rate (HDR) temporary prostate brachytherapy offers a precise form of dose escalation for prostate cancer. Needles are placed, the position is confirmed and treatment is delivered. Previously High Dose Rate prostate brachytherapy was performed under TransRectal UltraSound (TRUS) guidance but planned with Computed Tomography (CT) imaging which introduced a source of error through needle displacement while transporting and repositioning patient. Recently Varian has introduced a one-step procedure where both implant and planning are based on UltraSound imaging and performed without patient repositioning. This planning system is approved by Health Canada and is commercially available.

This study will use High Dose Rate brachytherapy to treat 20 men. Treatment will be planned with TransRectal UltraSound and validated using Computed Tomography imaging.

Twenty men with intermediate risk prostate cancer, suitable for the combination of external beam radiotherapy and High Dose Rate brachytherapy will be entered in this study. High Dose Rate brachytherapy will be performed using TransRectal UltraSound guidance and then planned using both cone-beam Computed Tomography and TransRectal UltraSound. Planning by Computed Tomography is to check the reliability and reproducibility of UltraSound imaging to correctly identify the needle positions. Correct needle localization is essential because this is the basis for determining source dwell positions, dose calculation and dose optimization.

Eligibility Criteria:
Inclusion Criteria:

1. Patients must have histologically proven adenocarcinoma of the prostate.
2. Patients must have intermediate risk prostate cancer. (Clinical stage ≤ T2c, Gleason score = 7 and initial prostate specific antigen (iPSA) ≤ 20, or Gleason score ≤ 6 and iPSA \> 10 and ≤ 20.
3. Patients must be fit for general or spinal anaesthetic.
4. Patients must have an estimated life expectancy of at least 10 years.
5. Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2.
6. Patients must have no contraindications to interstitial prostate brachytherapy.
7. Patients on coumadin therapy must be able to stop therapy safely for at least 7 days.

Exclusion Criteria:

* Men not able to fully understand the trial and the informed consent document
* Men suffering from claustrophobia and unable to have a Computed Tomography scan
* Men not wishing to have a cone-beam Computed Tomography scan following the insertion of the High Dose Rate brachytherapy needles to verify the accuracy of the treatment plan
* Men who cannot safely discontinue blood thinners for a few days.
Routine Versus Selective Midtrimester Ultrasound in a Poorly Resourced Setting: a Cluster Randomised Controlled Trial

It is debatable whether routine ultrasound scanning of pregnancies at about 20 weeks of pregnancy has substantive benefits for mothers and babies. Few studies have addressed this issue in poorly resourced settings. This trial will attempt to determine the benefits, if any, of a policy of routine ultrasound scanning of normal pregnancies versus a policy of no routine (only selective) scanning. This will be done by recruiting about 900 women in South Africa, and randomly allocating about half to routine scanning and half to selective scanning groups, and following up their pregnancies.

Routine ultrasound scanning in the second trimester of pregnancy has few substantive benefits, according to the results of number of randomised trials, mostly performed in industrialised countries. While ultrasound did not seem to prevent fetal death, it was associated with improved detection of multiple pregnancies, improved detection of congenital abnormalities and reduced need for postterm labour induction. Only one trial, from Cape Town, has investigated the benefits of a policy of routine second trimester ultrasound scanning in an under-resourced setting.

This will be cluster randomised controlled trial, performed in the Krugersdorp area of South Africa, where most health service users are African, working class and dependent on government health facilities. About 900 low-risk pregnant women at less than 24 weeks gestation will be recruited, and randomised, in clusters, to either routine scanning or no scanning with recourse to selective scanning if clinically indicated.

Women will be followed up for maternal, fetal and neonatal outcome, and for indices of health service utilisation. Important outcome measures will be need for subsequent ultrasound,detection of multiple pregnancy, detection of congenital abnormalities, postterm pregnancy induction, still birth,and neonatal morbidity and mortality.

Data analysis will compare outcomes according to whether routine ultrasound scanning was or was not done, using standard statistical methods.

Eligibility Criteria:
Inclusion Criteria:

* Pregnancy, 24 weeks pregnant or less, willing to participate

Exclusion Criteria:

* High risk pregnancy condition, e.g. poor past obstetric history, hypertensive disease, previous caesarean section
Diagnosis and Definition of Local Involvement of Musculoskeletal Tumors: Assessment of Ultra-high Field MRI Exploration Contribution

Sarcomas are aggressive malignant tumors issued from mesenchymatous cells. Their curative treatment is mainly surgical, especially in soft tissue sarcomas, which are mostly localized in limbs. Surgical margins remain a major prognosis factor and are directly linked to recurrence risk. Curative surgery applies resection margins removing healthy tissue surrounding the tumor and is meticulously planned thanks to tight cooperation between expert surgeons and radiologist, based on pre-operative Magnetic resonance imaging(MRI). Resection planning optimizes chances to perform a safe carcinological resection procedure sparing these structures. Resection planning is based upon conservation (or sacrifice) of anatomic compartments limited by fascia and routine MRI might also be outdated in some cases to predict whether the fascia is involved in the tumor or not. Such uncertainties complexify the surgical procedure, lead to unnecessary healthy tissue sacrifices and increase functional impairments, which can be significant. A new MRI offering higher spatial resolution could allow tumoral satellites, previously undetected on conventional MRI, which might explain some of the observed recurrences. Ultra-high field MRI, considered as harmless and without pharmaceutical agent injection, could bring benefits to tumoral extension comprehension and should be considered as a breakthrough in medical oncology field. This is particularly true in soft tissue sarcoma pathology field, where the only curative treatment to date remains surgery.

It will be propose in this project to determine the contribution of ultra-high field MRI in Soft tissue sarcomas management and to evaluate for the first time the potential superiority of 7 Tesla imaging over routine MRI through usual data comparison in 20 patients between 1,5Tesla and 7 Tesla MRI.


Eligibility Criteria:
Inclusion Criteria:

* Major patients
* All patients with soft-tissue sarcoma
* Patients agreeing to participate in the study and having signed a consent

Exclusion Criteria:

* Patients with a contraindication to MRI will be excluded: Claustrophobia, metallic foreign bodies, cardiac pacemakers, implantable chamber. There is no known additional risk for 7Tesla MRI scanning. The same contraindications as those of conventional MRI prevail.
* Patients with bone-component sarcomas will be excluded in order to have a homogeneous group of tumors localized only in the soft tissues (and simpler analysis in high-field MRI because of the risk of artifacts related to bone).
* Intermediate malignancies will be excluded for the same reasons.