cyrilzakka/clinical-trials huggingface dataset:
Effects of Canola Oil and Coconut Oil on Postprandial Metabolism in Older Adults With Increased Cardiometabolic Risk

The aim of this study is to investigate the postprandial effects of fat content and fatty acid composition of mixed meals on parameters associated with cardiometabolic diseases. Therefore, older subjects with increased risk of cardiometabolic diseases consume 4 mixed meals with 25 or 50 g of either canola or coconut oil. In a postprandial period of 6 hours, outcomes associated with cardiometabolic risk (e.g., triglycerides) are analyzed.

In a crossover design, 30 older men and women with increased risk of cardiometabolic diseases consume 4 mixed meals, enriched with either 25 or 50 g canola or coconut oil. During a postprandial period of 6 hours, parameters of lipid metabolism (e.g., plasma triglycerides), glucose metabolism (e.g., plasma glucose, serum insulin), as well as markers of inflammation (e.g., IL-6), vascular system (e.g., pulse wave velocity) and antioxidant system (e.g., trolox equivalent antioxidative capacity) are analyzed. Furthermore, fatty acid profile, neuropsychologic parameters (e.g., attention), subjective feeling of hunger and satiety, and satiety-associated hormones (e.g., ghrelin) are assessed. Each intervention arm will be separated by a washout period of about 14 days.

Eligibility Criteria:
Inclusion Criteria:

* BMI: 27 - 34,9 kg/m2
* Waist circumference: women ≥ 80 cm, men ≥ 94 cm
* At least two of the following criteria of metabolic syndrome:

Fasting triglycerides in serum: ≥ 150 mg/dl Fasting HDL-Cholesterol in serum: women \< 50 mg/dl, men \< 40 mg/dl Systolic blood pressure: ≥ 130 mmHg, diastolic blood pressure: ≥ 85 mmHg Fasting glucose in plasma: ≥ 100 mg/dL

Exclusion Criteria:

* Smoking
* Diseases that may impact outcome measures (e.g., thyroid diseases, insulin-dependent diabetes mellitus, impaired renal function, tumors, anemia)
* Intake of immunosuppressives or supplements (e.g., fish oil)
* Participation in another study
Quinoa Biscuit & CVD Risk Trial

Cardiovascular disease (CVD) is one of the most common chronic diseases in older populations, which has been increasing in line with rising overweight and obesity levels in recent years. Dietary intake is a major modifiable risk factor for CVD, and one such recommendation is to increase the intake of essential (omega-3) polyunsaturated fats in our diets, for example by consuming more oily fish. We know, however, from large population level dietary surveys, that many individuals within the United Kingdom (UK) population are not consuming enough oily fish. Therefore, alternative dietary sources of omega-3 polyunsaturated fats are required to help meet consumer needs.

Quinoa is a traditional Andean seed crop consumed in a similar fashion to staple cereal grains in Europe, and the popularity of quinoa has been growing worldwide because of its nutritional content and perceived healthiness. Quinoa contains a small amount of fat, but the ratio of omega-6 and omega-3 essential fats is more favourable in quinoa than in other plant oils. An opportunity therefore exists to incorporate quinoa flour into more frequently consumed food products (e.g. biscuits) as an alternative means of increasing consumers omega-3 intake.

The purpose of this study is to investigate the effect of consuming quinoa-enriched biscuits, compared to control, on markers of CVD risk over 4-weeks in older adults.


Eligibility Criteria:
Inclusion Criteria:

* Free-living, apparently healthy adults
* Aged 50-75 years at recruitment
* Low fish consumers (\<2 servings/wk)
* Non-smokers
* Not regularly consuming plant stanols

Exclusion Criteria:

* Non-free-living adults
* Aged \<50 or \>75 years at recruitment
* Fish consumers (2 servings/wk or more)
* Current smokers
* Pregnant/lactating females
* Coeliac disease, wheat intolerance or any other food allergy or intolerance that would prevent consumption of the biscuits
* Currently taking any fish oil-containing supplement
* Diagnosed with a chronic medical condition (such as diabetes; CVD autoimmune/ inflammatory disorders; cancer)
* Prescribed cholesterol or blood pressure lowering medications
* Daily consumption of plant stanols
Acute Impact of the Impella CP Assist Device in Pts. With Cardiogenic Shock on the Patients Hemodynamic

Prospective, monocentric open-label observational study for the assessment of acute hemodynamic effects following implantation of the IMPELLA CP cardiac support device


Eligibility Criteria:
Inclusion Criteria:

* Cardiogenic shock following acute MI or acute heart failure with

  * systolic BP \< 90 mm Hg over \> 30 min or inotropes for support of cardiac output and BP with
  * signs of left heart failure and pulmonary congestion
  * and end-organ hypo perfusion with somnolence or cold, pale skin, or oliguria or serum lactate \>2 mmol/l

Exclusion Criteria:
enCompass Carolina: A Social Support and Coaching Program for Cancer Caregivers

This study explores the feasibility, acceptability, and preliminary efficacy of a social support intervention in cancer caregivers who live in rural communities. Cancer caregivers need support, especially when they live at a distance from healthcare centers. enCompass Carolina is a social support intervention, that supports caregivers by helping them find and use new sources of support. The purpose of this study is to test and receive feedback about the program.


Eligibility Criteria:
Inclusion Criteria

Inclusion criteria for caregivers In order to participate in this study a subject must meet all of the eligibility criteria outlined below.

1. English-speaking.
2. Ability to provide written or electronic informed consent to participate in the study.
3. Subject is willing and able to comply with study procedures based on the judgment of the investigator or protocol designee.
4. Age ≥ 18 years at the time of consent. Identify as an informal (unpaid) caregiver for a rural-dwelling adult with a stage II-IV solid tumor or any hematologic malignancy in active treatment (see eligibility criteria for patients).

Inclusion criteria for subjects with cancer In order to participate in this study a subject must meet all of the eligibility criteria outlined below.

1. Their identified caregiver is enrolled in the study
2. English-speaking.
3. Ability to provide written or electronic informed consent to participate in the study.
4. Subjects are willing and able to comply with study procedures based on the judgment of the investigator or protocol designee.
5. Age ≥ 18 years at the time of consent. Have a diagnosis of stage II-IV solid tumor or any hematologic malignancy receiving active treatment s, not including hormonal therapy

7. Live in a rural area according to the USDA's Rural/Urban Commuting Area (RUCA) score of \>4.

Exclusion Criteria

Exclusion criteria for caregivers

1. Unable to complete self-report instruments due to illiteracy, neurologic illness, inability to speak or read English, or other causes;
2. Existence of another co-morbid disease, which in the opinion of the investigator, prohibits participation in the protocol;
3. Participation in the intervention development phase of this intervention.

Exclusion criteria for subjects with cancer

1. Unable to complete self-report instruments due to illiteracy, neurologic illness, inability to speak or read English, or other causes;
2. Existence of another co-morbid disease, which in the opinion of the investigator, prohibits participation in the protocol;
3. Their caregiver does not enroll in the study or withdraws consent
Teenage Functional Hallux Limitus and Ankle Dorsiflexion Study

This study aims to identify a possible correlation between reduced mobility of the first toe under load and reduced mobility of the ankle ROM in healthy adolescent basketball players. To reach this goal, two non-invasive tests will be performed to measure the amount of movement of the ankle joint and the first toe.

Functional hallux limitus (FHL) is a common condition of the first metatarsophalangeal joint (MTF) characterized by reduced dorsiflexion (DF) under load and has a negative effect on load transfer during toe off.

This condition is especially common among athletes, even at a youth age, due to repeated loads that can lead to tissue and/or joint damage. The compensations that occur in athletes with an FHL can negatively affect sports performance and start injuries.

Limited ankle dorsiflexion under load is another element that can affect sports performance as well as predisposing to injury. Several studies have investigated its regional interdependence but only a few have hypothesized a correlation between this limitation and FHL.

The aim of this study is to understand a possible correlation between reduced ankle DF and reduced MTF dorsiflexion during loading, so that preventive action can be taken to reduce the risk of injury.

Participants will fill in a cross-check survey to establish if there are any predisposing factors for FHL or ankle DF reduction.

The dorsiflexion lunge test (DLT) will be used to measure ankle dorsiflexion. The Jack Test will be used to measure first toe dorsiflexion under load and the Dorsiflexion Lunge Test will be used to measure ankle DF.

Eligibility Criteria:
Inclusion Criteria:

* male teenages basketball players enrolled in a competitive sports club
* teenagers whose parents have signed the privacy and consent forms

Exclusion Criteria:

* athletes who have suffered in the last 3 months of lower limb musculoskeletal disorders such as pain for more than 7 days (ankle distortion outcomes, leg/foot fractures, plantar fasciopathy, metatarsalgias, etc);
* athletes who have undergone surgery on their lower limb.
Impact of Human-Animal Interactions on Children With Life-Threatening Conditions and Their Parents

This study will evaluate the effects of human-animal interaction on reducing anxiety, depression, worry, and pain and enhancing quality of life in children ages 6-17 years old with a life threatening cancer and their parent caregivers.

Objectives:

* To examine the feasibility of human-animal interaction (HAI) sessions for children with a life threatening cancer and a primary caregiver, specifically to:

  * To identify and document necessary modifications for a safe and feasible intervention
  * To obtain recruitment estimates and determine potential recruitment barriers
  * To evaluate elements of implementation fidelity (design, training, delivery/receipt of treatment, enactment)
  * To verify safety
* To determine the preliminary efficacy of human-animal interaction sessions:

  * On children with a life threatening cancer for the outcomes of qualify of life, anxiety, depression, worry, and pain
  * On caregivers of children with a life threatening cancer for the outcomes of stress and anxiety

Exploratory Objective:

- To explore mechanisms (reduced salivary cortisol and urinary norepinephrine levels) associated with 8 weeks of human-animal interaction.

Eligibility Criteria:
Inclusion Criteria:

Child:

* Children age 6-17 years old that have been diagnosed with advanced cancer as defined by any stage of relapsed, recurrent or refractory cancer
* Able to understand English or Spanish to complete consents and surveys

Parent or Guardian:

* Parent or guardian as determined by person who brings child to \>50% of their clinic visits
* Able to understand English or Spanish to complete consents and surveys

Exclusion Criteria for both Children and Parent/Guardian:

* Self-reported fear of or allergies to canines
* Cognitive impairment as identified by healthcare team or inability to complete consenting process
The 2015 Pelotas (Brazil) Birth Cohort Study

This is the fourth birth cohort to be carried out in the city of Pelotas (Brazil) including more than 4 thousand children followed-up since the pre-natal period to study maternal-child health.

The Pelotas 2015 Birth cohort is the fourth birth cohort being established in Pelotas since 1982. Data is being collected with a focus on maintaining fidelity to the tools and instruments used in the previous cohorts with minimal adaptations when necessary. All children born in Pelotas during 2015 were included in the cohort, and the cohort has been followed four times, at birth, 3, 12 and 24 months (ongoing). In addition, an antenatal study identified and interviewed 73.8% of the mothers that subsequently delivered children that are now part of the cohort. The 4275 children included in the cohort are part of extensive assessments that include information on antenatal health and care, pregnancy health, gestational age, physical activity, sleep, health behaviours, socio-demographic characteristics, perinatal conditions, child anthropometry, delivery information, child mortality and morbidity, nutrition, growth, breastfeeding, neuro-cognitive development, access to health services, medicine use by both mother and child and genetic material. The cohort also nests 2 randomized clinical trials and a series of sub-studies. The data is starting to be analyzed and, among other findings, confirm the already alarming trends in surgical deliveries, amounting to 65.2% of all deliveries in 2015.

Eligibility Criteria:
Inclusion Criteria:

* live births
* mothers living in urban area of the city
* delivered during 2015

Exclusion Criteria:

* stillbirths below 500g
* mothers living outside Pelotas
The Performance / Safety of the Celsite® Venous Access Ports

The Celsite® Venous Access Ports System are intended to be used for repeated intravenous administration of, for example, chemotherapy, antibiotic and antiviral drugs, total parenteral nutrition, blood sampling or transfusion.

The objective is to assess the device's safety to deliver medication over the time in regard to the rate of adverse events related to the Celsite® access ports written in the IFU.


Eligibility Criteria:
Inclusion Criteria:

* Patient is at least 18 years old
* Provision of voluntary consent to participate in the study, following a full explanation of the nature and purpose of the study, by signing the informed consent form approved by the Ethics Committee (EC) prior to all evaluations.
* Patient for whom the access port placement has already been determined as the best treatment option within the regular planning of the patient's treatment in accordance with the IFU.
* Patients who are mentally and linguistically able to understand the aim of the study and to show sufficient compliance in the following study protocol

Exclusion Criteria:

* Patient for whom the technical and/ or clinical characteristics of the access port placement or use is outside the scope of the IFU.
* Patient not followed-up in the center where the access port is implanted.
* Pregnancy
* Patient \< 18 years of age
The Effect of Pediatric Patient Temperament on Postoperative Outcomes

The goal of this study is to determine if preoperative temperament is associated with postoperative pain, emergence agitation, emotional and behavioral changes, and overall parent satisfaction. This is a prospective observational study to assess preoperative temperament in pediatric patients undergoing tonsillectomy and adenoidectomy, gather demographic data, intraoperative data regarding surgical and anesthetic technique, and collect immediate postoperative data to assess pain, emergence agitation (EA), parental satisfaction as well as remote postoperative data to assess emotional and behavior changes. These data will be used to determine if patients with a specific temperament profile are more likely to experience increased pain, emergence agitation, emotional changes, and behavioral disturbances postoperatively.


Eligibility Criteria:
Inclusion Criteria:

* ASA I or II
* undergoing Tonsil and/or Adenoid Removal at Boston Children's Hospital

Exclusion Criteria:

* history of prematurity
* major chronic medical conditions
* neurological impairment or developmental delay
* parents/guardians who do not speak English or are unable to understand the questionnaires
The Effect and Safety of Combined Anti-platelet Treatment in Acute Ischemic Stroke Due to Large Artery Atherosclerosis

Currently, aspirin plus clopidogrel is considered as a standard acute treatment of ischemic stroke, based on results of CHANCE and POINT trial. However, still a considerable portion of patients showed early stroke recurrence, especially in those with stroke due to large artery atherosclerosis. Cilostazol may have benefit in reducing early stroke recurrence of neurologic deterioriation. The post-hoc analysis of CSPS.com showed that use of cilostazol after 15 days of stroke was effective for preventing subsequent stroke. The effect of adding cilostazol was more effective in those with large artery atherosclerosis and those receiving clopidogrel than aspirin.


Eligibility Criteria:
Inclusion Criteria:

1. Age of 20 years or older
2. Acute ischemic stroke due to large artery atherosclerosis (both including Intra and extracranial atherosclerosis) which may be defined by a ischemic lesion confirmed at diffusion-weighted image and a corresponding significant stenosis (more than 50% of diameter reduction) proximal to the ischemic lesion confirmed by MR or CT angiography.
3. Able to start IMP within 72h from stroke onset
4. Acquisition of written informed consent prior to study entry

Exclusion Criteria:

1. Large infarction unable to start antiplatelet treatment
2. Combined with acute intracranial haemorrhage
3. With initial haemorrhagic transformation
4. Previous mRS higher than 2
5. Indicated for anticoagulation
6. Contraindication for aspirin, clopidogrel or cilostazol
7. Requirement of long term NSAID
8. Pre-planned for surgery
9. Unable to withdraw consent
10. Unavailable to participate based on judgement of the investigator
11. Participants of reproductive potential (PORP)/ Participants of childbearing potential (POCBP) who do not agree to practice methods of birth control or remain fully abstinent from sexual activity with the potential for conception.
Study to Assess the Effect of ONS Nutridrink® 200 ml on the Recovery of Patients With COVID-19 and Respiratory Support

The goal of this low-interventional study was to learn about the effect a nutritional supplement in patients with COVID-19 and respiratory support. The main questions it aimed to answer were:

* if additional nutrition support has an effect on recovery of physical health in patients with COVID-19;
* to examine the effect of additional nutrition support on quality of life of patients with COVID-19;
* to examine the effect of the additional nutrition support on hospitalization period of patients with COVID-19.

Participants were split into two groups. One group had the common hospital diet, another group in addition to the common diet was given with NutriDrink® 200 ml X 2 daily. During the observation period participants were asked to measure hand strength measured by hand grip tester and fill out the quality of life standard questionnaire SF-36. In addition, several routine blood tests were performed.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed new coronavirus infection COVID-19 (based on laboratory and/or computer tomography data);
* Need in respiratory support (oxygen insufflation, non-invasive lung ventilation, artificial lung ventilation, as well in a prone position);
* Ability to take food spontaneously in the amount of 60% and more of energy and protein needs (possibility of spontaneous food intake will be determined with the three-swallow test; consumed food will be controlled with the "quarter of a plate" method);
* The informed consent is signed by a patient for the study enrollment and processing of personal data.

Exclusion Criteria:

* Diabetes mellitus;
* Renal failure;
* Hepatic failure;
* Systemic disease;
* Active cancer;
* Poor survival prognosis.
* Aggravation of a patient's condition requiring his transfer to enteral feeding and/or parenteral nutrition;
* Occurrence of complications requiring surgical interventions;
* Patient's transfer for treatment to another inpatient unit;
* Complications induced by the product for additional nutrition support (diarrhea, nausea, vomiting);
* Withdrawal of the informed consent for the study enrollment and processing of personal data.
Efficacy of Telerehabilitation Intervention Program Using Telebiofeedback Among Computer Operators

In the recent decades, with technology development, computer workstation has become fundamental both at work and at home environments, and is now used routinely for many purposes. Musculoskeletal disorders (MSD) are most often characterized by backaches, neck and upper extremities pain, discomfort and pain in joints, muscles and soft tissues. Since it has been found that many musculoskeletal disorders are connected, among others, to biomechanical and psychosocial factors relating to a person's work environment, the literature refers to them as Work Related MSD (WRMSD). Risk factors correlated with WRMSD include repetitive motions, awkward positions or static muscle loading over prolonged periods of time, use of high keystroke force, direct mechanical pressure, vibration and extreme temperatures. Computer operators found to be sitting statically for a long time in front of the computer and keyboard, with limited options of changing body position. Psychosocial factors have also been implicated in the workstation musculoskeletal disorders with computer operators. Workers with WRMSD may suffer from persistent pain, loss of function and work disability. Therefore, it may include changes in the employment and earnings for injured workers. The complex nature of these injuries suggests that workplace rehabilitation interventions are a crucial aspect of treatment management.

The main objective of this study is to explore the use of biofeedback intervention, based on tele-rehabilitation principle, with computer operators suffer from WRMSD. Treatment efficacy will be tested by use of RULA (Rapid Upper Limb Assessment) method. Data analysis will be done by ANOVA Repeated Measures.

Hypothesis: Biofeedback intervention, based on tele-rehabilitation principle, will be found effective with computer operators suffer from WRMSD.


Eligibility Criteria:
Inclusion Criteria:

* computer operators who spend more than 4 hours a day working with computer
* computer operators who suffer from pain and inconvenience or injury in upper limbs, such as Lateral Epicondylitis, de Quervain disease, Carpal Tunnel Syndrome (CTS), Ulnar Tunnel Syndrome, Flexor-Extensor peritendinitis or teno-synovitis of the forearm-wrist region.

Exclusion Criteria:

* subjects who suffer from neurological injuries
* subjects who suffer from orthopedic injuries or other metabolic or autoimmune diseases, that cause joint oedema or hand numbness (pregnancy, diabetes, heart disease and arthritis).