cyrilzakka/clinical-trials huggingface dataset:
A Study of PEP02 in Combination With 5-fluorouracil (5-FU) and Leucovorin (LV) in Advanced Solid Tumors

This trial is a multi-center, open-label, phase I, dose escalation study of PEP02 (liposomal encapsulated irinotecan) in combination with 5-FU and LV in patients with advanced solid tumors.

In this study, the initial starting dose of PEP02 is 60 mg/m2, and was escalated by increments of 20 mg/m2 between dose levels. 5-FU and LV was given as 24-hour infusion via an implanted central venous catheter, with dose fixed at 2000 mg/m2 and 200 mg/m2, respectively. PEP02 was administered on Day 1; 5-FU/LV was started after the end of PEP02 infusion on Day 1 and also on Day 8. Treatment repeated every 3 weeks and it was regarded as one cycle of treatment.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed solid tumor which was locally advanced or metastatic and had failed to standard chemotherapy or no standard treatment was available
* ECOG performance status 0 or 1
* With normal organ and marrow function

Exclusion Criteria:

* Have had major surgery, chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or have not recovered from toxicities due to previous treatment
* With known or suspicious primary or secondary brain tumors
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to PEP02, 5-FU or leucovorin
* HBsAg+ or anti-HCV+ patients with splenomegaly (defined as spleen size \> 11 cm in CT scan)
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, and history of symptomatic congestive heart failure of Functional Class II or more (New York Heart Association) and ischemic heart diseases (i.e. myocardial infarction or angina pectoris), cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
* Pregnant or breast feeding females (a pregnancy test must be performed on all females who are of child-bearing potential before entering the study and the result must be negative)
* Had received irinotecan treatment
Caries Transmission Prevention in Alaska Native Infants

The purpose of this study is to conduct a community based, randomized control trial to determine if the use of chlorhexidine mouth rinse and xylitol-sweetened chewing gum will reduce the vertical transmission of caries between Alaska Native mothers to their infants.

Alaska Native children are disproportionately affected by early childhood caries, compared to all U.S children. Dental care needs for adults and children in rural Alaska far exceed the acute care and prevention resources available. As a result, there is a high level of dental morbidity present among adults that likely contributes to early transmission of mutans streptococci (MS) from adult caregivers to infants in the household. Furthermore, the cultural practice of pre-mastication of solid food for infant feeding amplifies the transmission of oral secretions from adult to child. The prevention of early MS acquisition and subsequent caries in infants and toddlers requires efforts starting at birth. Since Alaska Natives are a rural population at high risk for caries, interruption of vertical transmission of MS using a combination of improved oral hygiene practices, and topical antimicrobials and bacteriostatic agents may be an ideal prevention strategy for childhood caries. Chlorhexidine and xylitol are two agents that have been shown to reduce dental decay and MS counts.

The specific aim of this proposal is to conduct a community based, randomized blinded trial to determine if the serial use of chlorhexidine and xylitol will reduce the vertical transmission of caries between Alaska Native mothers and infants. We hypothesize that a two week period of twice-daily chlorhexidine mouthwash use prior to delivery, followed by a subsequent two year period of maternal xylitol gum use, will lead to a significant reduction in the age-specific prevalence of early childhood caries at 12 and 24 months of age among the offspring of mothers in the intervention group, compared to control group mothers. We also hypothesize that, compared to controls, mothers and children in the intervention group will have significant reductions in oral MS counts at each follow-up interval.

If proven successful, this intervention could have a significant impact on the prevalence of caries among young Alaska Native children and other population groups at high risk for childhood caries.

Eligibility Criteria:
* primiparous or multiparous pregnant Alaska Native mothers of all ages
* in the last month of pregnancy
* reside in the health service delivery area of the native health corporation, in one of the communities with the highest birth counts from 2002
* eligible for obstetric care from the health corporation
* plan to give birth to their infant in a specified city of Alaska
Feasibility Study of Dialysis Clinic Semi-Autonomous Ultrasound Scanning Using the Vexev Ultrasound Imaging System for Arteriovenous Fistula Mapping Examinations. the CANSCAN Trial.

Study to assess the feasibility of dialysis clinic staff to perform upper limb mapping ultrasound scans using the Vexev Ultrasound Imaging System.


Eligibility Criteria:
Inclusion Criteria:

1. Referred to a study site for chronic renal replacement therapy OR referred to a study site for management of CKD.
2. Able to understand the procedures and requirements of the study and provide written informed consent and authorization for protected health information disclosure.
3. Greater than or equal to 21 years of age at the time of written informed consent.

Exclusion Criteria:

1. Patients' unable to load arm into scanning bed (due to upper limb medical co-morbidities/injury).
2. Patient has evidence of open or incompletely healed wounds on both arms. Patients with open or incompletely healed wounds on a single arm are not excluded - if the ipsilateral arm is not able to be scanned - contralateral arm may be scanned.
3. Any acute or chronic condition that would limit the ability of the patient to participate in the study - in the opinion of the principal investigator.
4. Previous vascular/vascular access surgery on both upper limbs. Patients with previous vascular/vascular access surgery on a single arm are not excluded- contralateral arm may be scanned.

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Health Values and Spirituality in Veterans With HIV/AIDS

We have previously shown that: 1) time tradeoff utilities for current health are high, indicating that patients have a strong will to live; 2) half of patients felt that their life was better now than before they were HIV-infected; and 3) certain non-health-related factors such as spirituality and concern and love for one�s children correlated with health values and a sense that life has improved.

Background:

We have previously shown that: 1) time tradeoff utilities for current health are high, indicating that patients have a strong will to live; 2) half of patients felt that their life was better now than before they were HIV-infected; and 3) certain non-health-related factors such as spirituality and concern and love for one�s children correlated with health values and a sense that life has improved.

Objectives:

1) To assess health values of veterans and non-veterans with HIV/AIDS; 2) To characterize spirituality in patients with HIV/AIDS; 3) To derive a power function relating health ratings to utilities; and 4) To assess whether society assigns higher values to health states for veterans than for non-veterans.

Methods:

We interviewed 100 representative veterans with HIV/AIDS from the Cincinnati and Pittsburgh VAMCs and, concurrently, 350 non-veterans with HIV/AIDS from Cincinnati and Washington, DC, twice over 12-18 months. The patient questionnaire included clinical and demographic data; health values measures; a question comparing life now with life before being infected with HIV; and measures of health status/health concerns, HIV symptoms, depressive symptoms, spirituality/religion, adherence, social support, self-esteem, and optimism. We also assessed how medical house officers rate and value the health state of a hypothetical patient with congestive heart failure, identified either as a 72-year-old veteran or merely as a 72-year-old male.

Status:

Data collection completed ahead of schedule. Several manuscripts published with others to be submitted soon.

Eligibility Criteria:
Inclusion Criteria:

Adults with HIV/AIDS

Exclusion Criteria:
Addressing Social Vulnerabilities in Cardiovascular Disease

The investigators will conduct a feasibility study of an enhanced transitional care intervention, that will: 1) automate identification and risk-stratification of patients with CHF and IHD with social vulnerabilities; 2) incorporate a new standardized social vulnerabilities screening tool into clinical care; 3) enable electronic referrals to community resources; and 4) add novel community-based interventions to the existing medically-oriented transitional care intervention that is the standard of care at the study hospital (Parkland Hospital in Dallas, Texas) and other hospitals nationwide.

The investigators plan to develop, pilot and evaluate the feasibility of an existing medically oriented transitional care intervention enhanced to also address social vulnerabilities, to prevent readmissions in congestive heart failure (CHF) \& ischemic heart disease (IHD). The intervention design will be based on the Andersen Behavior Model of Health Services Use, highlighting pathways for clinical linkages to community resources to facilitate individual behavior change. To summarize, although existing interventions have largely focused on individual- and health system-level factors such as optimizing medication regimens, discharge education, and post-discharge follow-up, much of the risk for readmission in patients with CHF and IHD is also driven by social vulnerabilities that are currently not addressed in medical settings. Community-based organizations are a valuable but untapped resource to ameliorate key social vulnerabilities (i.e., food/housing insecurity, behavioral health needs) that are major barriers to effective medication and visit adherence, self-management and lifestyle modification in patients with heart disease. Thus, the investigators propose an enhanced transitional care intervention that uses the Dallas Information Exchange Portal, a health information technology platform, to link patients to local community organizations at discharge. Addressing social vulnerabilities to enable better adherence, self-management, and lifestyle behaviors can in turn prevent readmissions and improve downstream health outcomes. The investigators will conduct a feasibility study of an enhanced transitional care intervention, that will: 1) automate identification and risk-stratification of patients with CHF and IHD with social vulnerabilities; 2) incorporate a new standardized social vulnerabilities screening tool into clinical care; 3) enable electronic referrals to community resources; and 4) add novel community-based interventions to the existing medically-oriented transitional care intervention that is the standard of care at Parkland and other hospitals nationwide. The investigators will assess feasibility and acceptability of our intervention using measures derived from the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) implementation science framework.

Eligibility Criteria:
Inclusion Criteria:

* patients hospitalized with CHF and IHD at high-risk for readmission

Exclusion Criteria:

* none
Clinical Evaluation of the Care On Line Thermometer

The purpose of this clinical study is to evaluate the performance of the COL thermometer by comparing its measurement to equilibrium measurement and to make a final tuning of the thermometer algorithm.


Eligibility Criteria:
Inclusion Criteria:

* Children (1-18 years old) in the pediatric or emergency department, with or without fever.
* An informed consent was signed by the patient's guardian.

Exclusion Criteria:

* The medical staff decides that participating will damage patient recovery.
The Impact of Food Advertisements on Brain Response and Eating Behavior in Children

The purpose of this project is to examine the impact that television food advertisements have on brain responses and eating behavior in children. Food advertisements enhance children's liking and intake of foods that tend to be high in energy content and low in nutritional value. Although several studies have measured the differences in children's food intake after watching advertisements, none have shown the brain mechanisms associated with this change in behavior. In order to clarify the relationship between food advertising and eating behavior, the investigators have assembled a team with expertise in functional imaging, eating behaviors, and clinical pediatric research. First, the investigators will observe the differences in children's eating behaviors after being exposed to food commercials or non-food commercials. Second, the investigators will measure the difference in child brain response to high and low energy foods after being exposed to food commercials or non-food commercials. These data will allow us to identify which areas of the brain are specifically affected by exposure to food commercials and correlate activity in these areas with children's measured food intake in the laboratory. Children ages 7-9 will participate in this 5-visit study which will be completed over the course of 12 months. Understanding how food advertisements impact children's brain responses and subsequent eating behaviors will have implications for understanding why some children respond differently to these cues than others. These outcomes may also inform the development of more effective programs and policies to prevent childhood obesity.


Eligibility Criteria:
Inclusion Criteria:

* Right-handed
* English as native language
* Reading at/above grade level
* Not Claustrophobic
* Generally Healthy

Exclusion Criteria:

* Left-handedness
* Metal in or on body that cannot be removed
* Claustrophobic
* Medication usage that may alter brain activity or blood flow
* Medical disorder that may impact comfort or safety in MRI scanner
* Food allergies
The Move for Your Health Pilot Study

The Move for Your Health Pilot Study is a 16-week study in older cancer survivors to replace and break-up sedentary activity with short bouts of light physical activity.

This pilot study will determine the feasibility and acceptability of a mobile health (mHealth) intervention to replace and break-up sedentary time with intermittent bouts of light physical activity. The intervention uses an electronic activity monitor ("Jawbone UP2"; worn on the wrist) that pairs with a mobile app, which together promote awareness and enable self-monitoring of both physical activity (steps per day) and inactivity (wristband gently vibrates after a specified time of inactivity). Pre-post intervention change in objective, subjective, and biologic data will be compared between groups.

Eligibility Criteria:
Inclusion Criteria:

* Age 60 years or older at the time of enrollment
* Diagnosed with local or regionally staged cancer (any site) and completed primary treatment
* Own a smartphone capable of running the "Jawbone UP2" app
* Willingness to be randomized to any of the 3 study arms, attend 2 clinic visits, and wear activity monitors (activPAL and actiGraph) at weeks 1 and 16 for 7 days; "Jawbone UP2" wristband monitor during weeks 2-16 during waking hours.
* Able to read, speak, and understand English.
* Living independently and capable of walking 3 blocks (approximately 1300 steps or 0.25 mile) without an assistive device (e.g., cane, walker)
* Residence within Bernalillo County or the four surrounding counties (to reduce travel burden)

Exclusion Criteria:

* Currently participating in a program to decrease sedentary time or increase physical activity
* Paid employment or volunteer position for greater than 20 hours per week
* Severe impairments or pre-existing medical limitations for engaging in daily light physical activity
* Wrist size \>20 cm
Epidiolex and Drug Resistant Epilepsy in Children

This open-label, multi-center study is open to patients 1 to 18 years of age at time of enrollment with medication resistant epilepsy.

This open-label, multi-center study is open to patients 1 to 18 years of age at time of enrollment with medication resistant epilepsy. The study consists of an 8 week baseline, titration, and treatment of Epidiolex in a daily dosage up to 25 mg/kg/day, with an optional secondary titration schedule after 26 weeks of treatment up to a maximal daily dosage up to 50 m/kg/day until End of Treatment, followed by a taper-down period, and a safety follow up. Treatment will be provided for a total of 52 weeks with an interim analysis conducted 12 weeks after achieving maximal dose (either 25 mg/kg/day or optimal dose with regards to safety and tolerability) and at the end of 1 year of treatment with treatment extensions conducted beyond 52 weeks until such time as there is market authorization for Epidiolex, if Epidiolex becomes unavailable, or the study is terminated. Cessation of Epidiolex administration will be concluded with a taper period and follow-up visit 4 weeks after the taper.

Eligibility Criteria:
Inclusion Criteria:

* Patient should have history of trying at least four antiepileptic drugs (AEDs), including one trial of a combination of two concomitant drugs, without successful seizure control. Vagal nerve stimulation, RNS deep brain stimulation, or the ketogenic diet can be considered equivalent to a drug trial.
* Patient must be taking two or more AEDs at a dose which has been stable for at least four weeks.
* A State of Georgia resident.

Exclusion Criteria:

* Patient is diagnosed as having Dravet Syndrome or Lennox-Gastaut Syndrome and eligible for a GW Pharmaceutical-Sponsored Clinical Trial.
* Patients who have been part of a clinical trial involving another investigational product in the previous six months.
Digital Symptom Tracking, Patient Engagement and Quality of Life in Advanced Cancer

The purpose of this study is to (1) describe patient and clinician engagement in web-based symptom self-monitoring, (2) identify differences in symptom management between intervention and usual care groups, and (3) identify potential outcomes of real-time symptom tracking and management.

With the assistance of the study coordinator, participants randomized to the intervention will create an account with Noona. Patients will be instructed to log symptoms as often as relevant using their own personal devices. Patients will also be prompted once per week for 24 weeks to log any recent symptoms. These participants will be sent a Symptom Questionnaire (SQ) via the Noona tool that summarizes their symptoms and distress one week prior to each oncology clinic visit. Symptoms designated as clinically severe either during regular symptom logging or via the SQ will trigger a prompt to contact the clinical team for immediate follow-up.

New patients from three cancer care programs (thoracic oncology, gastrointestinal oncology, and palliative care) at two academic institutions (Stanford and UCSF) will be screened for demographic and disease stage data within the patient medical record. Eligible patients will be asked by their oncology team whether they would be interested in participating a study of symptom management in oncology care.

Patients who express interest and ability to participate will be interviewed to determine eligibility.

Eligibility Criteria:
Inclusion Criteria:

1. Individuals (men and women) aged 18 years or older
2. Biopsy proven (recurrent or metastatic) advanced lung or gastrointestinal cancer
3. No limit on prior lines of therapy in the metastatic setting
4. ECOG performance status of 0-2
5. Estimated life expectancy of at least 6 months
6. Access to smartphone, tablet or computer with capability to utilize symptom tracking application
7. Willing and able to provide written, signed informed consent after the nature of the study has been explained, and prior to any research-related procedures
8. Willing and able to comply with all study procedures

Exclusion Criteria:

1. Concurrent disease or condition that interferes with participation or safety
2. Non-english speaking, as the application is developed in the english language
3. Non-castrate resistant prostate cancer
4. Enrolled in other non-therapeutic or therapeutic clinical trials
Online Prenatal Trial in Mindfulness Sleep Management

The aim of this study is to assess an online mindfulness intervention for pregnant women (6 weeks) for the treatment of insomnia and prevention of depression relapse in pregnancy. This mindfulness intervention will also be compared with an online intervention (6 weeks) consisting only of education about insomnia in pregnancy. The principal hypothesis is that the mindfulness intervention will be more effective than the education-only intervention.

The aim of this study is to assess an online mindfulness intervention for pregnant women (6 weeks) for the treatment of insomnia and prevention of depression relapse in pregnancy.

There will be two groups:

1. An online mindfulness intervention for pregnant women (6 weeks) that focuses on behaviors to overcome sleep difficulties in pregnancy.
2. An online control group that will receive information about sleep in pregnancy (6 weeks).

Each group will be composed of 25 participants with a total sample of 50. The principal hypothesis is that the mindfulness intervention will be more effective than sleep education in the improvement of sleep and depression symptoms during pregnancy.

The differences between the intervention and control group will be analyzed. The acceptability and usability of online content will also be assessed.

Eligibility Criteria:
Inclusion Criteria:

1) Viable pregnancy in second trimester (up to 28 weeks gestation); 2) prior diagnosis of depression currently in remission (score \< 3 on the Patient Health Questionnaire (PHQ-2) depression screening questionnaire); 3) subjective report of insomnia (score \> 7 on the Insomnia Severity Index); 4) age 18 or older; 5) access to an Internet-enabled smartphone, tablet, or computer; and 6) English fluency. Participants will not be excluded from participation if they are currently receiving psychotropic medications or psychotherapy.

Exclusion Criteria:

1) Known severe congenital fetal anomalies, fetal demise, or expected neonatal death; 2) diagnosis of major depressive disorder within past 2 months; 3) other significant psychiatric illness requiring treatment; 4) current hospitalization; 5) prior diagnosis of obstructive sleep apnea or restless leg syndrome; 6) positive self-report screen for restless leg syndrome; 7) regular mindfulness or meditative practice (at least weekly); and 8) regular night-shift work.
Clinical Pilot Study for Personalized Risk-based Breast Cancer Screening

The study aims to evaluate the impact of implementing population-based genetics testing strategy for breast cancer precision prevention using the polygenic risk score and monogenic pathogenic variant (MPV) testing in the Norwegian healthcare setting.

The study will recruit women age 40-50 referred for clinical mammography at the Vestre Viken Breast Center, with mammographic density BI-RADS a or d. After informed consent, saliva from the participants will be sampled and tested for polygenetic risk score (PRS) for breast cancer. The participants will be recommended future mammographic screening based on the PRS (standard screening, or more frequent/start at earlier age). The participants family history of cancer will be assessed, and if indicated, the participants will be referred for full genetic counselling/testing. The study will follow the women for 10 years for development of breast cancer as well as compliance to the recommended follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Women referred for clinical mammography in the Vestre Viken Breast Centre
* Breast density BI-RADS a or d
* 40-50 y.o.

Exclusion Criteria:

* Prior history of breast cancer or premalignant breast disease
* Prior genetic counselling/testing