cyrilzakka/clinical-trials huggingface dataset:
Effects of Intensive Locomotor Treadmill Training on Gross Motor Function in Young Children With Neuromotor Impairment

The purpose of this project is to examine if early exposure to intensive, short-term locomotor treadmill training (LT) in young children with neuromotor impairment will help develop walking skills earlier, decrease the amount of outside assistance needed (such as a walker or crutches) as compared to children with neuromotor impairment who receive traditional physical therapy intervention.


Eligibility Criteria:
Inclusion Criteria:

* a diagnosis of CP with GMFCS levels I and II
* ages 9 to 36 months
* the ability to sit for at least 30 seconds unsupported in ring-sitting or W-sitting
* the ability to take ten consecutive steps when held on hands

Exclusion Criteria:

* a diagnosis of a genetic syndrome
* independent ambulation without an assistive device
* previous or current use of treadmill intervention during physical therapy
* a medical contraindication for standing or walking defined by the physician 5) uncontrolled seizures
* a history of orthopedic surgery
* use of medication to control spasticity in the past 6 months
A First-In-Human Study of LY3985297 in Healthy Participants

The main purpose of this study is to see if LY3985297, the study drug, is safe and well-tolerated when given as a single dose or as multiple doses either through an intravenous (into a vein) or a subcutaneous (under the skin) injection in healthy participants. Study will also evaluate how much of the study drug LY3985297 gets into the blood stream and how long it takes the body to remove it.

The study is conducted in two parts (part A and B), each part has a separate treatment cohort.

The study will last up to approximately 116 days for part A, and 145 days for part B, including the screening period.


Eligibility Criteria:
Inclusion Criteria:

* Participants must be overtly healthy, as determined by medical evaluation.
* Have a body mass index of 18.0 to 32.0 kilograms per square meter (kg/m²), inclusive, and a minimum body weight of 45.0 kg.
* Participants must be assigned male or female at birth and not of childbearing potential.
* Have normal blood pressure, pulse rate, electrocardiogram (ECG), clinical laboratory test results that are acceptable for the study.
* Have venous access sufficient to allow for blood sampling.

For Part A Cohorts 5, 6, and 7:

* Participants must be first-generation Japanese only, defined as the participant's biological parents, and all of the participant's biological grandparents must be of exclusive Japanese descent and born in Japan. Or
* Participants must be first-generation Chinese only, defined as the participant's biological parents, and all of the participant's biological grandparents must be of exclusive Chinese descent and born in China.

Exclusion Criteria:

* Have a current or recent acute, active infection. For at least 30 days before screening and up to the randomization visit (Day 1).
* Had any surgical procedure (except for minor surgery requiring local or no anesthesia and without any complications or sequelae) within 12 weeks prior to screening or intend to during the study.
* Have a history of multiple or severe allergies, or an anaphylactic reaction, to prescription or nonprescription drugs or food.
* Show evidence of active or latent tuberculosis (TB).
* Have one of the following infections: hepatitis B, C virus or human immunodeficiency virus (HIV).
Saliva PCR in Pregnant Women with COVID-19

Abstract: Objectives We aim to study the relative viral load using saliva polymerase chain reaction among pregnant women treated with Paxlovid. Methods Pregnant women with coronavirus disease 2019 were allocated to two groups: those receiving Paxlovid and those receiving no antiviral agents. We compared the nasopharyngeal and salivary relative viral loads and their changes in saliva specimens. Results Among the 38 pregnant women, seventeen received Paxlovid, and 21 received no antiviral agents. The viral cycle threshold value of saliva was significantly higher than that from nasopharynx, with a median ± interquartile range of 26.44 ± 7.68 versus 17.6 ± 9.6 in the Paxlovid group (p = 0.005). Following treatment, the Paxlovid group showed a significant decrease in relative saliva viral load (cycle threshold value on Day 4/Day 5 minus Day 0) compared to the non-antiviral group (13.40 ± 5.64 versus -1.59 ± 9.63, p = 0.021). The detection rate of coronavirus disease 2019 using salivary polymerase chain reaction was 81.6% (31/38). Conclusions This study showed that saliva is a useful diagnostic tool for coronavirus disease 2019 in pregnant women, and a significant decrease in the relative viral load of saliva was observed in those treated with Paxlovid.


Eligibility Criteria:
Inclusion Criteria:

* This study enrolled pregnant women admitted to NCKUH 70 who tested positive for COVID-19 by real-time reverse transcription polymerase chain reaction (RT-PCR) of nasopharyngeal swab specimens. After providing the potential benefits and associated risks of antiviral treatment with Paxlovid, patients made a well-informed decision about whether or not to receive Paxlovid (300/100 mg nirmatrelvir/ritonavir, Pfizer Inc., USA) twice daily for 5 days.

Exclusion Criteria:

* Pregnant women were excluded if the time interval between the onset of symptoms and admission to our hospital was greater than seven days, in the case of insufficient saliva samples, or if any antiviral-related agents were administered, such as remdesivir, glucocorticoids, or interleukin-6 receptor antagonists.
Comparison of Minimal Versus Conventional Extracorporeal Circulation in Coronary Surgery

The aim of this study is to assess the effect of minimal (MiECC) versus conventional (CECC) extracorporeal circulation on perfusion characteristics and remote end-organ protection (lungs, brain, kidneys, liver, stomach, intestine), after elective coronary bypass grafting (CABG).

The aim of this study is to investigate whether coronary surgery with minimal Invasive Extracorporeal Circulation (MiECC) offers advantage over conventional CPB (CECC). In order to draw an evidence-based conclusion, the investigators aim to evaluate perfusion characteristics during coronary surgery with MECC and associated remote end-organ function. Improved end-organ protection translates into improved clinical outcome which greatly affects quality of life. This is the first study in the literature adequately powered to analyse organ pathophysiology during surgery with MECC and at the same time correlating common clinical variables with a detailed quality of life evaluation. Superiority of MECC could provide firm evidence towards widespread use of MECC in coronary surgery as standard of care.

Eligibility Criteria:
Inclusion Criteria:

* All patients scheduled for elective coronary artery bypass grafting

Exclusion Criteria:

* history of psychiatric disorder
* inability to undergo neuropsychological assessment
* history of transient ischemic attack or stroke
* carotid artery stenosis \> 60% assessed by duplex ultrasonography
Statins in Chronic Hepatitis C Patients Receiving Sofosbuvir/Daclatasvir Combination

The purpose of the study is to determine if statin can affect the clinical outcome of chronic hepatitis C patients receiving Sofosbuvir/Daclatasvir/Ribavirin combination

Aim of the work

To determine the benefits of statin use in CHC patients treated with Sofosbuvir/Daclatasvir/Ribavirin through :

Primary Outcome: Assessment of therapeutic SVR12

Seconadry Outcome

1. assessment of Chronic hepatitis C(CHC) infection risk on development of metabolic syndrome through assessment of lipid profile , fasting glucose test , HgbA1C and C-reactive protein(CRP).

2- Evaluation of CHC related complications such as fibrosis and cirrhosis

Patients will be followed up for the whole study period and will be subjected to assessment of the following:

1. CBC , liver function test , lipid profile and CK every month till the end of therapy.
2. HgA1C and CRP at the end of therapy.
3. HCV-PCR test 3 months after the end of therapy.
4. Fibrosis using (FIB-4) 3 months after the end of therapy.

Eligibility Criteria:
Inclusion Criteria:

1. Male patients age 18 to 70 years old.
2. Easy to treat group: treatment naïve patients with serum HCV RNA positivity by PCR.
3. Clinically stable condition outpatients.
4. Platelet count ≥ 150,000/mm³.
5. INR ≤ 1.2.
6. Serum albumin ≥ 3.5 g/dl.
7. Total serum bilirubin ≤ 1.2 mg/dl.

Exclusion Criteria:

1. Inadequately controlled diabetes mellitus (HbA1c \> 9%) .
2. Total serum bilirubin \> 3mg/dl.
3. HCV-HIV co infection.
4. HBV-HCV co infection.
5. Any cause for chronic liver disease other than hepatitis C
6. Uncontrolled hypothyroidism.
7. Hepatocellular carcinoma, except 4 weeks after intervention aiming at cure with no evidence of activity by dynamic imaging (CT or MRI).
8. Extra-hepatic malignancy except after two years of disease-free interval.
9. Child's C cirrhotic patients.
10. Creatinine kinase \> 350 u/l
Safety and Efficacy of AIN457 in Patients With Quiescent Non-infectious Uveitis

This extension study will assess the safety and efficacy of AIN457 versus placebo for maintaining uveitis suppression when reducing systemic immunosuppression


Eligibility Criteria:
Inclusion Criteria:

* Patients who have completed the entire treatment period of the 24 week core study

Exclusion Criteria:

* Inability or unwillingness to undergo repeated subcutaneous injections; inability to comply with study or follow-up procedures; any medical or psychiatric condition which, in the investigator's opinion wouldpreclude the participant from adhering to the protocol or completing the study per protocol.

Other protocol-defined inclusion/exclusion criteria may apply.
Irinotecan Liposomes Combined with Cetuximab + Vermofenib in First-line Failure of Advanced Colorectal Cancer

Efficacy and safety of irinotecan liposomes combined with cetuximab + vermofenib in first-line failure of advanced RAS wild /BRAF mutated colorectal cancer, Exploratory analysis of biomarkers (including but not limited to ctDNA, immune microenvironment indicators, tumor mutation load, lymphocyte subsets, cytokines, gut microbes, and others) in relation to efficacy.

This study aims to explore the following key questions: 1) whether replacing ordinary irinotecan in VIC protocol with irinotecan liposomes can improve the safety and efficacy of BRAF V600E mutation in second-line treatment of metastatic colorectal cancer; 2) To provide a reference for identifying the dominant population for the benefit of irinotecan liposomes through the exploration of a range of biomarkers (including but not limited to ctDNA, immune microenvironmental indicators, tumor mutation load, lymphocyte subsets, cytokines, gut microbes, and others). Thus, it provides more treatment options for BRAF V600E mutations in patients with metastatic colorectal cancer

Eligibility Criteria:
Inclusion Criteria:

* at least 18 years of age;
* Colorectal adenocarcinoma was confirmed by histological or cytopathological examination, and RAS wild /BRAF V600E mutation was detected by PCR or NGS;
* Failure or intolerance of standard first-line treatment. First-line regimens including oxaliplatin and/or irinotecan in combination with fluorouracil in patients with MSS; For BRAF V600E mutated patients with MSI-H, first-line immunotherapy with PD-1 or PD-L1 is required;
* At least one measurable lesion according to RECIST v1.1;
* ECOG score is 0\~2;
* Good bone marrow and organ function: ① Neutrophils (ANC) ≥1.5×109/L, platelets (PLT) ≥100×109/L, hemoglobin (Hb) ≥90g/L, white blood cells (WBC) ≥3.0×109/L, albumin (ALB) ≥32 g/L, and no bleeding tendency; ② AST, ALT and alkaline phosphatase (ALP) were all ≤2.5× upper limit of normal range (ULN), and ≤5×ULN when liver metastases occurred; Total bilirubin ≤1.5×ULN; Serum creatinine (Cr) ≤1.5×ULN or creatinine clearance ≥60 ml/min (calculated according to Cockroft-Gault);
* Expected survival ≥3 months;
* Can understand the situation of this study, patients and (or) legal representatives voluntarily agree to participate in this study and sign informed consent.

Exclusion Criteria:

* Patients who have previously received BRAF inhibitors or irinotecan liposomes;
* Proven allergic to the test drug and/or its excipients;
* symptomatic, untreated brain metastases or meningeal metastases that fail to achieve clinical stability;
* Acute or subacute intestinal obstruction or chronic inflammatory bowel disease;
* have had other malignant tumors within the past 5 years or currently, except for cured cervical carcinoma in situ, uterine carcinoma in situ and non-melanoma skin cancer;
* Pregnant or lactating female patients, patients of childbearing age who refuse to accept contraceptive measures;
* Patients considered by the investigator to be unsuitable for this study.
Improving Decision Making On Location of Care With the Frail Elderly and Their Caregivers

One of the toughest decisions faced by the frail elderly in Canada is whether to stay at home or move to a care facility. It is certainly difficult to make this decision alone, but can be even harder if someone else makes it for you. Shared decision making is when, instead of making decisions for the patient, healthcare professionals share information about what the evidence says, and they talk about what's important with the patient, and then make the decision together. In the case of the frail elderly in home care services, there are many health care professionals involved, e.g. the doctor, nurse and social worker. In this case decisions should be shared by all the professionals involved with the elderly person along with his or her caregivers. Unfortunately, in this context, shared decision making rarely occurs.

We have designed a training program that teaches interprofessional teams how to share decisions with their frail elderly patients, and tested it in one Quebec City and one Edmonton home care team. This project tests the training program on a broader scale with 16 home care teams attached to community health centres across the province of Quebec, and will compare the results with what happens when no one has completed the training (usual care). Home care is a rapidly growing sector and this study will lay the foundations for a national strategy to ensure that no one has to make this difficult decision alone.


Eligibility Criteria:
Inclusion Criteria:

* Receiving care from the home care team
* Faced the decision about whether to stay at home or move to a care facility in the previous 3 to 6 months
* Able to read, understand and write french or english
* Able to give informed consent
* For the case of clients unable to provide informed consent, their caregivers who was involved into decision making process will be eligible

Exclusion Criteria:

* Clients who cannot provide informed consent (e. g. clients with cognitive impairment) without a caregiver
* Clients who require acute care hospitalization and whom the location of care decision is transferred to hospital-based social services
School Based Health Care: A Model for Improving Educational Achievement for Children in Inner City Schools

Developmental problems have tremendous impact on children, affecting academic achievement and mental health later in life.The process of receiving a developmental assessment is long and arduous, and may require multiple physician visits taking over one year. Although a relatively new concept in Canada, School-Based Health Centres (SBHCs) have been successfully implemented in over 1900 schools in the United States.The first SBHC in Ontario, and Canada as a whole, was established through the Model Schools Pediatric Health Initiative (MSPHI) and is dedicated to reducing health inequities for inner city children by reducing barriers and providing accessible clinical care. To provide more conclusive evidence on the relative benefits of SBHCs as compared to traditional health care access, this study will use a prospective cohort quasi-experimental study design to compare differences in educational achievement for developmental assessments in the SBHC model relative to standard care. As per standard of care, students having difficulty in school are identified by the Toronto District School Board (TDSB) internal research staff and are presented to the monthly School Support team (SST) meetings. Historically physicians do not attend SST meetings, however, as a part of the SBHC program, pediatricians will participate in monthly SST meetings. Schools assigned to the intervention group will have SBHC physicians attend SST meetings, while schools assigned to the control group will not.

The overall objective of this study is to examine educational achievement, as defined by standardized test scores and report cards in students who use an inner city SBHCs for developmental concerns relative to those who do not. We hypothesize students attending schools in which SST meetings have a pediatrician present, that are referred to a SBHC, will score higher and show a greater increase in standardized test scores and report cards (from baseline to follow-up) than students attending schools in which SST meetings do not have a pediatrician present and access services through traditional means in the community (standard of care).The secondary objectives are: a) to examine socio-demographic data for these students and its relationship to educational achievement and b) to determine wait times to developmental assessment for students in the intervention group who attend the SBHCs using retrospective chart review.


Eligibility Criteria:
Inclusion Criteria:

* All students identified at the SST meetings requiring a developmental assessment.

Exclusion Criteria:

* Students without a developmental concern and not identified at the SST meeting will be excluded. No other specific exclusion criteria will be applied.
Walnuts and Healthy Aging

This will be a systematic investigation of the role of walnuts in preventing or slowing age related cognitive decline and age related macular degeneration. 700 subjects will be recruited between 2 sites, Loma Linda University in California, USA and Hospital Clinic in Barcelona, Spain. Participants will be randomly assigned to either the walnut group or the control group for a 2 year intervention. Baseline and annual data will be collected and analyzed.

Epidemiological studies suggest that nutrients such as n-3 polyunsaturated fatty acid, antioxidants and B-vitamins may protect against age related cognitive decline. Small human studies have shown beneficial effects of polyphenol rich foods on cognition and age related macular degeneration. Walnuts are a rich source of n-3 polyunsaturated fatty acid, alpha-linolenic acid, antioxidants, polyphenols and other bioactive compounds. A 2-year intervention will be conducted with healthy, elderly subjects to investigate the role of walnuts in preventing or slowing age related cognitive decline and age related macular degeneration.

350 subjects, age 63 to 79 years, will be recruited at each of 2 sites, Loma Linda University in California and Hospital Clinic in Barcelona. Participants will be randomly assigned to one of two groups: walnut group (habitual diet with 1 or 2 oz/d walnut supplement) or control group (habitual diet only). At baseline and yearly, cardiometabolic risk factors, red blood cell membrane fatty acids, urinary polyphenols and biomarkers of inflammation and oxidation will be measured. Eye exam, blood pressure and cognitive function tests will be measured at the beginning and end of 2 years. At the Barcelona site only, participants will be given a brain MRI and carotid ultrasound.

Descriptive results will be reported as mean plus/minus standard deviation. Primary analysis will be carried out on the basis of groups as randomly assigned. Results will be presented as appropriate effect sizes with a measure of precision (95% CI). Analysis of covariates gender, age, educational status will be conducted.

Eligibility Criteria:
Inclusion Criteria:

* 63 to 79 years old
* healthy men and women
* able to attend clinic at a study sites

Exclusion Criteria:

* illiteracy or inability to understand the protocol
* unable to undergo neurophysiological tests
* morbid obesity (BMI greater than or equal to ≥ 40 kg/m2)
* uncontrolled diabetes (HbA1c\>85)
* uncontrolled hypertension
* prior cerebrovascular accident
* any relevant psychiatric illness, including major depression
* advanced cognitive deterioration, dementia
* other neurodegenerative diseases (i.e. Parkinson's disease)
* any chronic illness expected to shorten survival (heart, liver, cancer, etc)
* bereavement in the first year of loss
* bad dentures unless fixable dental prostheses are used
* allergy to walnuts
* customary us of fish oil or flaxseed oil supplements
* eye related exclusion criteria
Characterization of Medical Student Burnout Using Remote Physiologic Monitoring

A reliable method for monitoring stress and burnout among medical students is critically needed. To address this gap, our team aims to utilize the cost-effective WHOOP strap 4.0 wearable device to continuously capture stress-relevant physiologic data (i.e., sleep hours, heart rate variability, respiration rate, resting heart rate) among up to 50 third-year medical students at 24 Sidney Kimmel Medical College at Thomas Jefferson University for 6 months.

Aim 1: To determine whether physiologic metrics of sleep and heart rate variability correlate with subjective assessments of medical student wellness in a 6-month period.

Hypothesis: Less total sleep hours will correlate with higher scores for Perceived Stress Scale-4, Medical Student Well-Being Index, and Patient Health Questionnaire-9, but lower heart rate variability will correlate with higher scores on Perceived Stress Scale-4, Medical Student Well Being Index, and Patient Health Questionnaire-9.

Aim 2: To determine whether physiologic metrics of sleep and heart rate variability correlate with performance on shelf examinations for clinical rotations in a 6-month period.

Hypothesis: Less total sleep hours and lower heart rate variability will correlate with poorer performance on shelf examinations.

Eligibility Criteria:
Inclusion Criteria:

* Third-year medical student at Thomas Jefferson University
* ≥18 years of age
* Actively participating in family medicine, internal medicine, neurology, obstetrics/gynecology, pediatrics, psychiatry, surgery, or emergency medicine rotations
* Own a smart phone for Bluetooth pairing with WHOOP strap 4.0

Exclusion Criteria:

* Allergies, contraindications, or unwillingness to wear a wrist device for the study period
Empowering Physicians With Evidence-Based Decision Support for Pediatric Rheumatology

This study compares the ability of clinicians to make diagnoses with or without the assistance of diagnostic decision support software. The area of clinical focus is primarily rheumatology.

The study uses written case vignettes, not decisions about patients seeking care from the study subjects (i.e., clinicians).

Eligibility Criteria:
Inclusion criteria: Clinicians in various medical specialties

Exclusion criteria: Non-clinician
Long-term Follow-up of Lichtenstein's Operation Versus Mesh Plug Repair

Long-term follow-up of a randomized clinical trial of Lichtenstein's operation versus mesh plug for inguinal hernia repair based on the following published study "Randomized clinical trial of Lichtenstein's operation versus mesh plug for inguinal hernia repair. Br J Surg. 2007 Jan;94(1):36-41."

Primary endpoints is recurrence.


Eligibility Criteria:
Inclusion Criteria:

* 40 years and older, patients who became 40 in the year of the operation were included (6 patients younger than 40 years were included because of explicit patient's wish).
* provision of written informed consent,
* symptomatic unilateral or bilateral inguinal hernia.

Exclusion Criteria:

* presence of a femoral hernia,
* history of hernia repair with mesh,
* type I diabetes,
* presence of local or diffuse infection (urine, skin, lung, sepsis),
* immune deficiency,
* severe medical problems contraindicating safe induction of general anaesthesia or elective surgery,
* pregnancy,
* malignant tumours and
* life expectancy of less than 2 years