cyrilzakka/clinical-trials huggingface dataset:
Impact of Educational Group Intervention on the Consumption of Fruit and Vegetables

The right to food and nutrition is established in the Universal Declaration of Human Rights as they are basic requirements for promoting and protecting good health. They can also be instruments to evaluate the quality of life of human beings and communities. Awareness of a healthy diet is the first step in behavioral change, and nutritional education can be an instrument for avoiding diseases resulting from both intake deficit and excess. Educational group actions can change food intake. This study will aim at evaluating, planning and implementing the impact of a nutritional education group action concerning the consumption of fruit and vegetables in adult and elderly individuals attended to by a Primary Health Care (PHCU) Unit. It will be a randomized assay involving two groups comprising male and females individuals distributed in the following fashion: Intervention Group, in which the educational group action (EGA) will be performed in addition to routine activities; and Control Group, the individuals from which will only participate in the routine activities in the PHCA (Teaching Health Care Unit). The total sample will comprise 80 individuals with 40 in each group. In order to determine the consumption of fruit and vegetables, a weekday and a Sunday 24-hour recalls will be performed 2 (short-term effects) and 6 (medium-term effects) months after completing the intervention. The educational group activities will consist of two-hour group dynamics and cooking workshops once a week and for five weeks. Serum carotenoid dosages will also be performed in the two groups by sub-sampling (n=40) with the purpose to validate the estimated intake of fruit and vegetables obtained from the recalls.


Eligibility Criteria:
Inclusion Criteria:

* adult healthy

Exclusion Criteria:

* pregnancy, lactation, morbidity
BSSPlus Versus Lactated Ringer's for Phacoemulsification

Two intraocular irrigating solutions (BSSPlus versus Lactated Ringer's) are compared in this prospective, randomized, masked trial to investigate for differences in preservation of corneal integrity after phacoemulsification cataract surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients with senile cataract
* Visual acuity between 20/400 and 20/40

Exclusion Criteria:

* Presence of corneal opacity
* Presence of corneal disease
* Traumatic, toxic, hereditary (congenital)and complicated cataracts(uveitis)
* Anterior chamber cells or flare detected before surgery
* Previous ocular surgery
* Any condition which may affect documentation or follow-up
Rapid and Highly Sensitive Detection of Fluorescently-labeled Troponin in Patients Admitted With Chest Pain

Patients with chest pain may have postponed or missed diagnosis of acute coronary events due to relatively late detection of troponin elevation. The study will investigate a new diagnostic method for early detection of even minimal troponin elevation in patients admitted with chest pain.

Patients with chest pain may have postponed or missed diagnosis of acute coronary events due to relatively late detection of troponin elevation. The study will investigate a new diagnostic method for early detection of even minimal troponin elevation in patients admitted with chest pain.

A new diagnostic method will be applicated in the recent studies.

Eligibility Criteria:
Inclusion Criteria:

1. Patients 18 years old or older
2. Admitted to Rambam health campus for the investigation of chest pain

Exclusion Criteria:

1. No exclusion criteria will be applied
Study of HER2 Directed Dendritic Cell (DC1) Vaccine + Weekly Paclitaxel, Trastuzumab & Pertuzumab

The purpose of the study is to find out if an investigational drug called Dendritic Cell (DC1) vaccine added to standard neoadjuvant (given before main treatment) therapy can help people with HER2 (human epidermal growth factor receptor 2) positive breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* Participants must have histologically confirmed clinical stage I- III, HER2+ (per ASCO/CAP criteria) invasive carcinoma of the breast. Primary tumor should measure at least 1 cm by clinical exam or radiologic tests
* Candidate for neoadjuvant chemotherapy with Paclitaxel, Trastuzumab, Pertuzumab regimen followed by standard of care local therapy as determined by the treating physician
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* Participants must have normal organ and marrow function as defined per protocol.
* Cardiac ejection fraction within institutional normal limits by either Multigated Acquisition Scan (MUGA) or Echocardiogram at baseline.
* Women of child-bearing potential and their male partners must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. Sexually active male participants should use a barrier method or exercise abstinence during chemotherapy administration until surgery.
* Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

* Participants with inflammatory breast cancer, widespread locally advanced unresectable disease involving the chest wall/nodal basins in which a curative surgical resection cannot be performed, or those in whom de novo metastatic disease is suspected or confirmed.
* Patients may not be receiving any other investigational agents for the treatment of their breast cancer.
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to the study vaccine components and any of the chemotherapy drugs (paclitaxel, trastuzumab, pertuzumab).
* Participants who are unwilling or unable to undergo an apheresis for production of their vaccine.
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
* Pregnant women and women who are breastfeeding.
* Participants with known congenital or acquired immune deficiency (including those patients who require systemic immunosuppressant drugs for autoimmune disease or organ transplant).
Korean Cardiac Arrest Research Consortium

This study will evaluated the epidemiology and the outcomes of patients suffering out-of-hospital cardiac arrest with presumed cardiac etiology in Korea.

The Korean Cardiac Arrest Research Consortium (KoCARC) is a collaborative research network developed to comprehend various researches conducted in the field of out-of-cardiac arrest resuscitation and to strengthen the cooperative effort in conducting studies. It was organized in 2014 with recruitment of hospitals willing to participate voluntarily to the consortium.

Not only for emergency medicine, but KoCARC is expanding the research collaboration with cardiology, preventive medicine and epidemiology as well. To enhance the professionalism and effectiveness in research, seven research committees, which consists of Epidemiology and Preventive Research Committee (EPR), Community Resuscitation Research Committee (CRR), EMS Resuscitation Research Committee (ERR), Hospital Resuscitation Research Committee (HRR), Hypothermia and Post-resuscitation Care Research Committee (HPR), Cardiac Care Resuscitation Committee (CCR) and Pediatric Resuscitation Research Committee (PRR). Also Data Safety and Monitoring Board Committee (DSMB) is organized to provide annual review and Security and Ethics Committee to oversight security and ethical issues in research. Monthly meeting of interdisciplinary steering committee, consists of the consortium chair, steering committee chair, each research committee chair and secretary committee, is held to approve the proposed research agendas and to mediate between multi-center trial participating hospitals.

KoCARC registry is a data collecting system composed of OHCA risk and prognostic variables developed to provide the platform to researches conducted in KoCARC.

Eligibility Criteria:
Inclusion Criteria:

* OHCA patients who were transported to participating emergency department (ED) by emergency medical service with resuscitation efforts and whose arrest was identified as a presumed cardiac etiology by emergency physicians in ED.

Exclusion Criteria:

* OHCA with terminal illness documented by medical record, under hospice care, with pregnancy, with pre-documented 'Do Not Resuscitate' card
* OHCA of definite non-cardiac etiology, including trauma, drowning, poisoning, burn, asphyxia, or hanging
Using Social Connectedness to Increase Physical Activity

A randomized controlled trial will test the effectiveness of social incentives relative to traditional incentives in promoting walking behavior among college students (N=200). Participants who are rewarded for walking together will be compared to those who are rewarded for walking even when alone. Research participants will download activity tracking apps (Fitbit app and AWARE app) that provide activity and location data. Participants will be consented and then randomized to one of two incentive schemes for walking. Over a 2-week intervention period, the standard incentive group will earn $2 per day when they meet their walking goal regardless of whether they walk alone or with others. The social incentive group will earn $1 per day when they reach their walking goal plus an additional $1 when they walk at least 2000 steps with their walking partner. The incentive scheme will be in place for 2-weeks, preceded by a 1-week baseline period and followed by a 2-week follow-up period.

The objective of the study is to test whether social incentives that encourage physical activity with another person are more effective than incentives for individual exercise. Physical inactivity and social isolation are growing epidemics linked to increased morbidity and mortality particularly among aging Americans. This research aims to address both problems by encouraging co-productive physical activities among college students. Co-productive physical activity mean anything involving physical activity that two people can do together, e.g., walking their dogs or shopping together. Additionally, in light of the COVID-19 pandemic, walking together in this study means either walking while communicating digitally or over the phone, or by physically walking together while wearing a mask, staying 6 feet apart, and following the recommendations from health professionals. A small randomized controlled trial will test the effectiveness of social incentives relative to traditional incentives in promoting walking behavior. Participants who are rewarded for walking together will be compared to those who are rewarded for walking even when alone. The results will indicate whether social incentives are more motivating than traditional incentives for walking behavior.

Eligibility Criteria:
Inclusion Criteria:

* Age 18+
* Able to read and understand English-language surveys
* Own either iPhone or Android smartphones
* Willing to carry the smart phone during the study period and to respond to daily texts or emails from the study team
* Registered for the study as a dyad (friend pairs), with one member of the dyad a Carnegie Mellon University student

Exclusion Criteria:

• Contraindications for increased physical activity
Managing Pain and Cognitions in Older Adults With Mild Cognitive Impairment or Memory Related Problems and Chronic Pain

We aim to conduct a pilot randomized controlled trial comparing 2 symptom management programs for older adults with self-reported memory problems and chronic pain, Active Brains 1 and Active Brains 2. We will assess how each program may help in improving coping with pain and coping with cognitive functioning. We will explore feasibility, acceptability, and credibility and within group changes in physical, emotional and cognitive functioning.

We aim to conduct a pilot randomized controlled trial comparing 2 symptom management programs for older adults with self-reported memory problems and chronic pain: Active Brains 1 Active Brains 2. We will assess how each program may help in improving coping with pain and coping with cognitive functioning. We will explore feasibility, acceptability, and credibility and within group changes in physical, emotional and cognitive functioning.

Each group meets for 8 90 minute sessions over a secure video platform. Each group has 5-8 participants. Participants receive a treatment manual. There are 2 assessment points: baseline, and post program. Assessments involve questionnaires, a walk test, and objective step count with ActiGraphs for 1 week.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients, age 60 years or older
* Have nonmalignant chronic pain for more than 3 months
* Has MCI or subjective memory related problems
* Able to perform a 6-minute walk test at an accelerated pace
* Owns a smartphone with Bluetooth 4.0
* Willingness and ability to participate in the Active Brains intervention and to comply with the requirements of the study protocol (including weekly sessions and Fitbit use)
* Free of concurrent psychotropic or pain medication for at least 2 weeks prior to initiation of treatment, OR stable on current psychotropic or pain medication for a minimum of 6 weeks and willing to maintain a stable dose
* Cleared by a medical doctor for study participation
* Leads a sedentary lifestyle

Exclusion Criteria:

* Diagnosed with medical illness expected to worsen in the next 6 months
* Serious mental illness or instability for which hospitalization may be likely in the next 6 months
* Current suicidal ideation reported on self-report
* Lifetime history of schizophrenia, bipolar disorder, or other psychotic disorder, or substance dependence
* Current substance use disorder, within the past 6 months
* Practice of yoga/meditation, or other mind-body techniques that elicit the relaxation response, once per week for 45 minutes or more within the last 3 months or less
* Regular use of Fitbit in the last 3 months
* Engagement in regular intensive physical exercise for \>30 minute daily
* Unable to walk without use of assistance (e.g., wheelchair, walker)
Substrate Oxidation in Children in Response to High and Low Dairy Intake

The investigators propose a randomized trial comparing higher levels of dairy intake compared to lower levels of dairy intake. Participants will be 20 boys and girls, age 10-13, overweight (\>85%) who are currently consuming 1 or fewer servings of dairy per day. Each participant will be randomized to either higher or lower levels of dairy intake. A baseline calorimeter stay will determine 24-hour energy needs. Participants will then receive the diet they have been randomized to receive for 6 days and will then have a second calorimeter stay. During this 2nd stay, each participant will continue to receive the diet they were randomized to receive and will achieve a 300 kcal energy deficit through physical activity. The investigators hypothesize that children who receive a 300 kcal energy deficit from the energy expenditure of exercise and receive 3 to 4 servings of dairy products will show greater increases in fat oxidation compared to children who receive a 300 kcal energy expenditure of exercise and receive 1 or fewer servings of dairy products.

The study objective was to conduct a randomized clinical trial comparing enhanced levels of dairy consumption to lower levels of dairy consumption during an energy deficit resulting from 300 kcal of exercise. Participants were 24 sedentary and overweight boys, 13-15 years of age and girls, 12 to 14 years of age, and consuming 1 or fewer servings of dairy and less than 600 mg calcium per day at baseline. Participants were randomly assigned to either higher or lower dairy for 6 days and then crossed over to the opposite treatment subsequent to 2 weeks of wash out. The investigators provided all meals and snacks for the participants during the higher and lower dairy conditions. During the wash out period, participants were instructed to consume their normal diet as assessed at baseline which consisted of 1 or fewer servings of dairy and less than 600 mg calcium. Participants stayed in the calorimeter at baseline, day 7, and day 28 (end of study), after crossover. The calorimeter measured substrate oxidation under the condition of a 300 kcal energy deficit due to exercise.

Eligibility Criteria:
Inclusion Criteria:

* Must be overweight
* and 10-13 years old
* currently consuming 1 or fewer servings of dairy
* less than 600 mg calcium per day

Exclusion Criteria:

* not meeting the above criteria
* must be present for duration of the study
Dietary Protein Requirements in Hemodialysis Patients

The primary purpose of this study is to assess dietary protein requirements in clinically stable maintenance hemodialysis (MHD) patients. It is hypothesized that the average dietary protein intake (DPI) that will maintain nitrogen balance is 1.00 g protein/kg/day, but that a safe intake that maintains balance in almost all MHD patients is about 1.25g protein/kg/day.

A high proportion of maintenance hemodialysis (MHD) patients have protein-energy malnutrition (PEM) which is a powerful predictor of high morbidity and mortality. Although inflammation may contribute to PEM, low dietary protein intake (DPI) is often a contributing factor. The usual DPI of MHD patients in about 1.0 g protein/kg/day, whereas expert groups recommend = 1.20 g protein/kg/day. However, these recommendations are based upon few studies, often of insufficient duration, that were usually carried out with obsolete types of dialysis therapy.

We will examine the response to different levels of dietary protein intake (0.6-1.3 g protein/kg/day) under classical balance techniques with carefully controlled dietary intakes, living, conditions, and collection of nitrogen outputs and carefully measured nitrogen intakes and outputs.

Eligibility Criteria:
Inclusion Criteria:

* Ages from 30 years through 65 years
* Both men and women and all ethnic and racial groups
* Treatment with MHD for 6 months or greater
* Hemoglobin of at least 11 g/dL
* Neurological examination indicating no severe neuropathy
* A negative test for peripheral arterial occlusive disease

Exclusion Criteria:

* Obesity: body weight greater than \>115% of standard
* History of active cancer other than basal cell carcinoma
* Symptomatic severe ischemic heart disease, uncontrolled serious dysrhythmias, uncontrolled congestive heart failure, poorly controlled hypertension, severe musculoskeletal disease, arthritis or amputations of the lower extremities
* Insulin dependent or insulin independent diabetes mellitus
* Severe lung or liver disease, uncontrolled asthma, active vasculitis. Severe chronic infection or any other acute or chronic inflammatory or catabolic illnesses
* Psychosis, inability to give informed consent, evidence that patient will not comply with study protocol
* Alcohol or other recreational drug abuse
* Patients who received L-carnitine or anabolic hormones within the previous 6 months
* Pregnancy
* Patients who are physically and/or psychologically incapable of undergoing the protocol
Dose Escalation of RMC-4630 Monotherapy in Relapsed/Refractory Solid Tumors

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) profiles of escalating doses of RMC-4630 monotherapy in adult participants with relapsed/refractory solid tumors and to identify the recommended Phase 2 dose (RP2D).

This is an open-label, multicenter, Phase 1 study of oral RMC-4630 monotherapy in participants with advanced relapsed or refractory solid tumors. The study will include 2 components: 1) a Dose-Escalation Component for participants with relapsed or refractory solid tumors and 2) a Dose-Expansion Component for participants with relapsed or refractory solid tumors harboring certain specific mutations/rearrangements that result in hyperactivation of the RAS-MAPK pathway. Participants will be treated until disease progression per RECIST v1.1, unacceptable toxicity, or other criteria for withdrawal are met, whichever occurs first.

Eligibility Criteria:
Inclusion Criteria:

* Participant (male or female) ≥18 years of age
* Participants who have advanced solid tumors that have failed, are intolerant to, or are considered ineligible for standard of care anticancer treatments including approved drugs for oncogenic drivers in their tumor type
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
* Participants in the Dose-Expansion Component must have one of the following genotypic aberrations: KRAS amplifications, KRASG12C (NSCLC), BRAF Class 3, or NF1 LOF (NSCLC and gynecological cancers) mutations
* Adequate hematologic, hepatic and renal function
* Participant able to understand and voluntarily sign the informed consent form (ICF) and able to comply with the study visit schedule and other protocol requirements.
* Participants willing to agree to not father a child/become pregnant and comply with effective contraception criteria

Exclusion Criteria:

* Known or suspected leptomeningeal or brain metastases or spinal cord compression
* Primary central nervous system (CNS) tumors
* Clinically significant cardiac disease
* Active, clinically significant interstitial lung disease or pneumonitis
* History or current evidence of retinal pigment epithelial detachment (RPED), central serous retinopathy, retinal vein occlusion (RVO), or predisposing factors to RPED or RVO
* Known HIV infection
* Active/chronic hepatitis B or C infection
* Any other unstable or clinically significant concurrent medical condition that would, in the opinion of the investigator, jeopardize the safety of a participant, impact their expected survival through the end of the study participation, and/or impact their ability to comply with the protocol prior/concomitant therapy
* Females who are pregnant or breastfeeding
Long-term Outcome in Pediatric Surgical Bypass Grafting After Traumatic Injury and Tumor Resection

Introduction:

Vascular bypass surgery in children differs significantly from adults. It is a rarely performed procedure in the setting of trauma and tumor surgery to facilitate limb salvage. Beside the technical challenges to reconstruct the small and spastic vessels, bypass grafting should not impede growth of the extremity. The primary aim of this study was to assess long-term outcome after pediatric bypass grafting, in a single academic center, focusing on potential effects on limb development.

Methods:

In this retrospective cohort analyses we included all pediatric patients undergoing vascular bypass grafting at the Medical University of Vienna between 2002-2017. All patients ≤ 18 years suffered a traumatic injury or underwent a tumor resection of the lower or upper limb, respectively. The youngest female patient was 0.4 years, the youngest male patient was 3.5 years.


Eligibility Criteria:
Inclusion Criteria:

* age \<18 years
* planned vascular bypass grafting

Exclusion Criteria:

* age \>18 years
* no vascular intervention