cyrilzakka/clinical-trials huggingface dataset:
Postprandial Responses to Fish Intake

Fish consumption has been increasing in recent decades due to consumer interest in the positive health effects of regular food intake, among other factors. Previous studies have described significant results on the acute consumption of fish products, favoring the reduction of triglycerides, total cholesterol, low-density lipoprotein, reduced insulin secretion, and increased plasma concentration of high-density lipoprotein during the postprandial period. Despite this scenario, studies investigating acute metabolic responses, such as postprandial physiological phenomena after consumption of the main fish species ingested by Brazilians, are still scarce. Thus, investigations of the acute effects of fish intake on postprandial metabolism may reveal new beneficial effects associated with this food group. The present proposal aims to compare the acute effects of the ingestion of two sources of fish and bovine protein on postprandial metabolism through the capillary blood sample collected within 5 hours after the ingestion of test meals, investigating hormones and inflammatory mediators and quantifying triglycerides, total cholesterol and non-esterified fatty acids and blood glucose, in addition to evaluating sensory aspects and satiety between different meals. It is expected to generate new data on postprandial physiology and investigate possible effects of fish ingestion that can contribute to public health management and healthy eating patterns.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adults between 18 and 35 years and with a body mass index between 20 and 29 kg/m2.

Exclusion Criteria:

* Individuals with a vegetarian/vegan diet, a history of fish allergy, aversion to fish, used supplementation with n-3 polyunsaturated fatty acids or probiotics, who have a diagnosis of pregnancy, dyslipidemia, diabetes, inflammatory bowel disease, liver disease, who have undergone surgeries that alter the anatomy of the digestive tract (bariatric surgery or cholecystectomy, for example) and use of antimicrobial therapy in the 3 months before the study will not be allowed to participate.
Kinematics of Knees of Patients With Tumor Around Knee After Microwave Ablation With Plate Internal Fixation

The aim of this study is to investigate kinematics of knees of patients with tumor around knee after microwave ablation with plate internal fixation


Eligibility Criteria:
Inclusion Criteria:

1. age \< 40.
2. Body mass index \< 30.
3. For controls, no history of major injury or surgery in lower limbs; no symptoms of lower limbs; physical examination to test the lower limbs to be healthy.
4. For MF group, patients With Tumor Around Knee After Microwave Ablation With Plate Internal Fixation for 6 months or more.

Exclusion Criteria:

1. Body mass index \>30.
2. For controls, injury or surgery in hip/knee/ankle.
3. For MF group, injury or surgery in hip/ankle;
4. Neuropathic disease.
5. Muscular disease.
6. Lack ability to finish the procedure physically or mentally.
7. Easy to fall.
8. Any other conditions that can influence gait parameters of the lower limbs.
Family Integrated Care in the NICU

In the highly technological environment of the modern neonatal intensive care unit (NICU), the infant is physically, psychologically and emotionally separated from its parents. Recognition that this impedes parent- infant interaction and is detrimental to the infant, led to the development of programs such as family centered care, kangaroo care and skin-to-skin care1-3. However, they are based on the common premise that only NICU professionals with special skills can provide care for the infant. Parents are relegated to a supportive role, and some have described themselves as voyeurs who are "allowed" to visit and hold their infants4. Many feel anxious and unprepared to care for their infants after discharge5.

In 1979, a shortage of NICU nurses in Estonia prompted Levin1,6 to implement a "humane" care model in which parents provided nursing care for the infant (except for administration of IV fluid and medication), while nurses provided teaching and guidance to parents. This resulted in 30% improvement in weight gain1,30% reduction in infections, 20% reduction in NICU length of stay, 50% reduction in nurse utilization and overall improved satisfaction among parents and staff \[personal communication, Levin,A.\]. Building on the Estonian experience, we have developed a new Family Integrated Care (FIC) model that is adapted for the NICU environment in North America. In a pilot study at Mount Sinai Hospital, Toronto 46 infants and their families were enrolled in the study. Preliminary results and feedback from parents and healthcare providers (HCP) show that the FIC model is both feasible and safe, and may lead to improved outcomes including improved weight gain(paper submitted for publication). This study is a cluster randomized controlled trial in 16 tertiary level NICUs, to evaluate the efficacy of the FIC model in Canada.


Eligibility Criteria:
Inclusion Criteria:

* \< 33 weeks gestational age at birth;
* On no respiratory support or low level respiratory support (i.e., oxygen by cannula or mask, or continuous positive airway pressure (CPAP);
* A primary caregiver parent who is willing and able to commit to spending at least 8 hours per day with her/his infant between the hours of 0700 and 2000;
* Parental consent.

Exclusion Criteria:

* Palliative care;
* Major life threatening congenital anomaly;
* Critical illness (unlikely to survive);
* On high level of respiratory support (mechanical ventilator, high frequency oscillatory or jet ventilation, extra-corporeal membrane oxygenation)
* Parental request for early transfer to another hospital;
* Parental inability to participate (e.g., health, social or language issues that might inhibit their ability to communicate with the healthcare team).
ASYMMETRIC LACK OF KNEE FLEXION AS A SYMPTOM OF DLM IN CHILDREN

Highlighted during the clinical examination of a knee flexion asymmetry, and related to the intraoperative meniscal observations on DLM.

Search for a link between asymmetric bending defect and posterior shift in MCA-type DLM.

Analysis of all patients with symptomatic DLM.


Eligibility Criteria:
Inclusion Criteria:

* \< 18 yo
* Symptomatic discoid lateral meniscus

Exclusion Criteria:

* Osteochondritis dissecans (OCD)
* Asymptomatic and partial DLM observed during arthroscopic exploration for other reasons
* Revision knee surgery
A Study of the Use of Factor XIII Concentrate in Patients With Inherited FXIII Deficiency

Congenital deficiency of Factor XIII is an extremely rare hereditary disorder associated with potentially life-threatening bleeding. This study will evaluate the safety and recommended (best) amount or level of Factor XIII in a patient's blood. Factor XIII Concentrate (Human) is given to people whose blood is lacking Factor XIII. Factor XIII Concentrate (Human) works by assisting your blood in the usual clotting process, thereby preventing bleeding.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent/assent for study participation obtained before undergoing any study-specific procedures
* Documented congenital FXIII deficiency that requires prophylactic treatment with a FXIII containing product.
* Males and females of any age with congenital FXIII deficiency.
* Received full hepatitis B vaccination and/or is hepatitis B surface antibody positive

Exclusion Criteria:

* Diagnosis of acquired FXIII deficiency
* Administration of a FXIII-containing product, including blood transfusions or other blood products within 4 weeks prior to the planned Day 0
* Any known congenital or acquired coagulation disorder other than congenital FXIII deficiency
* Known or suspected to have antibodies towards FXIII
* Use of any other investigational medicinal product within 4 weeks prior to the Baseline Visit (Day 0)
* Positive result at screening for human immunodeficiency virus (HIV)
* Serum aspartate transaminase (AST) or serum alanine transaminase (ALT) concentration \>2.5 times the upper limit of normal
* Fibrinogen \< lower limit of normal
* Active bleeding
* Pregnant or breast-feeding
* Intention to become pregnant during the course of the study
* Female subjects of childbearing potential not using, or not willing to use, a medically reliable method of contraception for the entire duration of the study
* Surgical procedure anticipated during the study period
* Suspected inability (e.g., language problems) or unwillingness to comply with study procedures or history of noncompliance
Medication Responsiveness in Parkinson's Disease

Up till now, dopaminergic replacement is considered as the gold standard for the symptomatic treatment of motor symptoms in Parkinson's disease (PD). However, the intake, especially higher doses when taken for a longer duration, are associated with several side effects including response fluctuations. These fluctuations in medication response are often characterized by a wearing-OFF period, also defined as the recurrence of PD symptoms before a patient should take the next dose of medication. The duration of test sessions during research experiments (e.g. in the field of rehabilitation) can interfere with the period of the optimal therapeutic effect of dopaminergic medication, influencing outcomes of a study. Therefore, the objective of this project is to get more insight in the measurability of ON-OFF fluctuations by testing the applicability of a short and simple timed tapping task (TTT) on a smartphone in rehabilitation research studies. The assessment can be useful for future clinical studies in PD where a precise estimation of medication is indispensable for accurate research outcomes.


Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of PD, based on the UK Brain Bank Diagnostic Criteria
* Hoehn \& Yahr stage I-III
* Mini Mental State Examination (MMSE) scores \>24
* Right-handedness
* No other known disease or disorder that will interfere with the experiments
Effects of Live Music on the Perception of Noise in the SICU: A Patient, Caregiver, and Medical Staff Environmental Study

The use of live music in SICU might affect the perception of noise, which may reduce staff's stress level and further decrease the possibility of clinical errors, reduce patient's anxiety and perception of pain as well as increase compliance from patient and family. Live music might also enhance the quality of stay and promote a holistic healing process for the patient.

In this study, the research team is looking at the effect of the live music provided by a trained music therapist, created through incorporating the noises in the SICU - such as the beeping of the machines as part of the elements in the music, to organize the sound environment as well as introducing familiar songs, chosen according to the cultures and ages of the patients, caregivers and staff, to increase a sense of familiarity and comfort. Through the intervention, the research team hope to ameliorate the effects of a noxious sound environment, which may reduce the stress level of the staff and increase their acuity level while decrease patients and caregivers' anxiety level and improve their mood state and the quality of hospitalization

Eligibility Criteria:
Inclusion Criteria:

* SICU patients, caregivers, and physicians/nursing staff

Exclusion Criteria:

* Non-medical Staff
Comparison of Multiparametric Prostate MRI and Ga-68 PSMA PET Imaging in Prostate Cancer Staging

In this study, it is aimed to compare the lesion location, lesion size, local and distant metastases detection rates of Ga68 PSMA PET and Multiparametric Prostate MR imaging tests used in staging in patients diagnosed with prostate cancer.

The pathologies of the patients who were decided to undergo radical prostatectomy as a treatment will also be compared with the staging tests.


Eligibility Criteria:
Inclusion Criteria:

* diagnosed with prostate cancer
* Gleason score 7 or above / 6 with high risk
* No other treatment

Exclusion Criteria:

* treated with radiotherapy
* treated with ADT
Post-release Retention in HIV Care for Ex-inmates in South Africa

HIV remains the leading cause of death in South Africa as a result of a failure of people living with HIV to seek HIV treatment and be retained in care. After initiating antiretroviral therapy while incarcerated, most ex-inmates fail to remain engaged in care. The goal of this research is to reduce mortality, morbidity, and HIV transmission by developing an actionable approach to retaining these individuals in HIV care.

To pilot a randomized clinical trial (RCT) of a transition adherence club (TCAC) versus traditional care, among ex-inmates receiving antiretroviral therapy in South Africa, to study feasibility, acceptability, and preliminary effectiveness using mixed methods.

Investigators will pilot an RCT of the TCAC compared to traditional care among inmates/ex-inmates measuring transition in care, six-month viral load suppression, and follow-up of participants. Feasibility will be assessed by process measures. Acceptability will be assessed using in-depth interviews among 36 participants and 10 staff. Effectiveness will be assessed by a difference in proportions in-care with an undetectable viral load at 6 months and difference in bonding social capital and care satisfaction between arms.

Eligibility Criteria:
Inclusion Criteria:

* Currently incarcerated (either an offender/sentenced inmates or awaiting trial inmate/remandee)
* Housed at one of the study correctional facilities (including participating satellite centres)
* Diagnosed with HIV
* Currently receiving antiretroviral therapy
* Anticipated release or trial date within 3 months of study enrollment
* Self-report expected to reside within Ekurhuleni, Tshwane, or Johannesburg districts of Gauteng Province and within proximity to one of the TCAC sites (within 20 km, 45 minute travel time, or two local taxi minibus rides)
* Agree to post-discharge follow-up
* Medically stable based on DCS health assessment (including not pregnant)
* On antiretroviral therapy (ART) for \>3 months at the expected time of corrections release

Exclusion Criteria:

* Failure to provide informed consent to be followed up by study staff after release
* Unable to speak one of the study languages (English, Sesotho, isiXhosa, isiZulu, Setswana, Xitsonga, and Afrikaans)
TOBI to Monitor Response to Neoadjuvant Therapy in Breast Cancer

The purpose of this research study is to see if Near-Infrared Tomographic Optical Breast Imaging (TOBI) scans can help monitor breast tumor response during treatment for breast cancer. The images created by the TOBI scan show changes in blood blow and oxygen levels in breast tissue.

* Participants will have a TOBI scan prior to starting their cancer treatment and again on day 8 after their first treatment. Participants will also be asked if they would volunteer to undergoing one or more additional TOBI scans on days 2-7 after they begin cancer treatment. These additional scans are optional. Participants will also have a scan on the first day of each treatment cycle.
* TOBI scans will be performed at the Gillette Center for Breast Cancer at the Massachusetts General Hospital.
* For the scan, each breast is placed between 2 plastic plates in order to spread the tissue apart, similar to the procedure for a mammogram. The TOBI scanner is attached to these plates. We will apply mild pressure to compress the breast and the breast will be scanned using light waves. Each scan will take about 3 minutes.

Eligibility Criteria:
Inclusion Criteria:

* Adult female patients presenting to the MGH Cancer Center Gillette Center for breast cancer neoadjuvant therapy
* Subject who have had or will have a clinically indicated pre-treatment breast MRI

Exclusion Criteria:

* Younger than 18 years of age
* Open wounds on breast
* Breast implants, because they may interfere with readings
* Subjects who will be receiving preoperative therapy for \<28 days
* Breast surgery or biopsy \< 10 days prior to optical imaging scan
* Medical or psychiatric or other medical condition that the principal investigator believes may result in inability to complete the study
* Bilateral breast cancers or a history of contralateral breast cancer
Rehabilitation in Chronic Obstructive Pulmonary Disease (COPD) Patients With Emphysema

Chronic Obstructive Pulmonary Disease has two heterogeneous conditions (chronic bronchitis and pulmonary emphysema phenotypes) with a different clinical presentation.

The phenotype evaluation in COPD patient (trough clinical, functional and radiographic parameters) could influence final results in pharmacologic and non-pharmacologic management of the disease.

The aim of our study is to investigate whether COPD patients with different disease phenotype (chronic bronchitis versus pulmonary emphysema) have a different response to PR.


Eligibility Criteria:
Inclusion Criteria:

* COPD disease with any functional grade
* Adherence to participate to a pulmonary rehabilitation program

Exclusion Criteria:

* Recent acute exacerbation (4 weeks preceding enrollment)
* Acute severe concomitant cardiovascular diseases
* Concomitant neoplastic diseases
* NO-Adherence to participate to a pulmonary rehabilitation program
Study of Effectiveness of rMV (Repeated Muscle Vibration) in Knee Osteoarthritis

The rehabilitation protocols in knee osteoarthritis are often difficult to be applied in elderly patients because they are long lasting and need the constant participation of patients. To rapidly improve the motor performances of patients it is possible to use the mechanical vibration applied to individual muscles using a protocol called "repeated muscle vibration" (rMV). The purpose of this single-blind randomized placebo-controlled study is to evaluate the effectiveness of the repeated muscle vibration (rMV) in terms of increasing the ability of the patients affected by knee osteoarthritis, compared to an ineffective treatment, considered as a placebo. Each subject, randomly assigned to either the group 1 (study group) or placebo-treatment (group 2)is administered 3 daily applications of rMV of 10 minutes each, for 3 consecutive days. Between two successive applications it's observed a break of at least 15 seconds. The probe of the specific instrument (Cro ® System) is placed near the supero-medial margin of the patella, on both quadriceps. Patients in group 2 (control group) are subjected to a treatment with muscle released in which the probe of the same instrument is approached to the quadriceps, without making contact. The instrument in these conditions emits a buzz but not provokes muscle vibration. The primary outcome of the study is to determine the changing in patients' ability (as measured by WOMAC scale = Western Ontario and McMaster Universities Osteoarthritis Index) . The secondary outcomes of the study are the assessment of changing of patients' balance and risk of falling (as measured by the Tinetti scale) and assessment of changing of patients' quality of life (as measured by EQ-VAS= EuroQuality of Life-VAS scale).Outcome measures are administered at baseline (T0), at the end of the treatment protocol (T1), at 1 month (T2), 3 months (T3) after the end of treatment and 6 months (T4) after the end of the treatment.


Eligibility Criteria:
Inclusion Criteria:

* Knee Osteoarthritis

Exclusion Criteria:

* Neurologic disease involving the lower limbs or causing balance problems
* Systemic inflammatory diseases
* Diabetic Neuropathy
* Severe heart disease.
* Acute infections or bone Tuberculosis
* Prosthetic lower limbs
* History of surgery on the affected knee in the last year
* History of cancer
* Cognitive impairment
ARTHR-IS (Arthroplasties' Infections Due to Staphylococcus Aureus)

The number of arthroplasties is expected to grow in the next few years. Staphylococcus aureus (SA) is a primary cause of prosthetic joint infection (PJI) with serious consequences. This microorganism is frequently associated with treatment failure, hospitalizations and need of prosthesis removal, leading to an important morbidity and an increase in healthcare costs.

ARTHR-IS is a retrospective multi-center study which aims to estimate the burden of SA-PJI after a hip or knee arthroplasty and their risk factors. Other objectives are to quantify the costs, the number of hospitalizations and the surgical procedures needed to treat and control the infection and finally the factors influencing therapeutic failure.

Through a case-control design, ARTHR-IS will group 20 hospitals across 5 European countries in order to include 150 cases and 450 controls.

The results of this study will provide critical information to develop strategies to prevent and treat SA-PJI and reduce treatment failures. Also, the results from ARTH-IS study will help in the design of future clinical trials in prosthesis infections by providing reliable estimates on the incidence of SA-PJI and the subsequent burden on health care services.


Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent a primary hip or knee arthroplasty between 2013 and 2016.
* Diagnosis of SA -PJI in the first 12 months after primary arthroplasty.

Exclusion Criteria:

• Patients with a previous SA infection or prosthesis revision on the index joint (joint which was replaced during arthroplasty).
Implementation of HBB Training With Facilitators That Have Undergone Simulation Methodology Training

Helping Babies Breathe (HBB) implementation is associated with reduction in neonatal deaths and reduction in fresh stillbirths. HBB has successfully integrated some aspects of simulation into an educational curriculum that teach the management of neonatal emergencies in resource-constrained countries.

Simulation based training brings special advantages and may enhance HBB training. Critical elements of simulation such as enhanced realism and post-event debriefing may carry potential to strengthen HBB training to attain maximum impact. However, evidence for the effectiveness of this combined approach is limited.

Helping Babies Breathe (HBB) implementation is associated with reduction in neonatal deaths and reduction in fresh stillbirths. HBB has successfully integrated some aspects of simulation into an educational curriculum that teach the management of neonatal emergencies in resource-constrained countries.

High levels of physical, emotional and conceptual realism are important features of simulation-based learning that impact learning outcomes. Formal debriefing is characterized as the most important element of simulation based education. Structured feedback in a safe learning environment provides the opportunity for learning of clinically relevant material. Guided reflection transfers the responsibility for learning to the participants and solidifies knowledge, skills and behaviors for transfer to clinical practice.

Simulation based training brings special advantages and may enhance HBB training. Critical elements of simulation such as enhanced realism and post-event debriefing may carry potential to strengthen HBB training to attain maximum impact. However, evidence for the effectiveness of this combined approach is limited.

Eligibility Criteria:
Inclusion Criteria:

* Only trained facilitators are eligible to participate
* Must hold a Faculty position or are a health care provider at KIU Teaching Hospital in western Uganda
* Are engaged in teaching health students.
* Participating medical students are those enrolled at KIU Teaching Hospital in western Uganda

Exclusion Criteria:

* Faculty and hospital workers who are not engaged in teaching health students.
* Medical students not enrolled at KIU Teaching Hospital, western Uganda