cyrilzakka/clinical-trials huggingface dataset:
The System Fammeal With Tailored Recommendations and Gamification for Parents to Counteract Childhood Obesity

The investigators aim to test an evidence-based intervention, allocated to a mobile app designed to parents and their children with 3 to 6 years old, identified by family doctors or nurses at well-child care visits as overweight or obese for age.

This intervention aims to improve parent's perceptions and attitudes regarding children's weight status and food intake, leading to better dietary intake and children's' eating behaviors through positive parental child-feeding practices. In this study, the investigators aim to assess the feasibility of the intervention and explore its impact on the beliefs and attitudes of parents.

The investigators will enroll parents and their children with 3 to 6 years old, identified by family doctors or nurses at well-child care visits as overweight/obese for age.

Participant's eligibility will be assessed. Participants will be randomized to: 1) control group; 2) intervention group. The control group will receive treatment as usual. Parents in the intervention group will be provided with the app and invited to use it for 4 weeks. During the 4 weeks, the administrator monitors the app usage and call once to parents to improve it, if needed.

Both groups will perform a pre- and post-test, evaluating parent's perceptions and attitudes regarding children's weight status and food intake; eating behaviors and parental child-feeding practices.

Eligibility Criteria:
Inclusion Criteria:

* Children with 36 to 83 months at the start of the intervention.
* Children overweight or obese for age, according to World Health Organization criteria.
* Parent/ caregiver with at least 18 years old.
* Parent/caregiver involved in child feeding management (≥ 5 in a 0-10 rating scale, from 'Not at all' to 'Extremely involved').
* Parent/ caregiver able to read, speak and understand Portuguese.
* Parent/caregiver with an android device.
* Parent/caregiver willing to participate in the research study, to participate in two face-to-face evaluations, to install and use the app and to receive weekly notifications and 1-3 calls, during 4 weeks.

Exclusion Criteria:

* Children with any medical conditions that affect growth, intake or physical activity.
* Children with any dietary professional advice, in the last 6 months.
The Effect of Using Smart Glasses Integrated Ultrasonography on Radial Artery Catheterization

The use of Ultrasonography (USG) in arterial catheterization, in which the comfort of the practitioner and hand-eye coordination become very important, is frequently needed by anesthesiologists in their daily practice. The aim of this study is to evaluate the success rate and anesthesiologist's satisfaction between two practitioners with different levels of experience in radial artery catheterization with smart glasses USG.

The arterial catheterizations were usually performed by anesthesiologists in operation rooms and intensive care units for many reasons such as blood pressure monitoring and gas sampling. The choice of radial artery is because of its anatomic advantages. However some patients related features can cause difficulties in catheterization. The use of ultrasounography (USG) guidance raises the rate of success and decreases the complications. Coordination skills between hand, eye, procedure area and screen are essential for the USG-guided catheterization. Smarth glasses, project the USG image in real-time directly in front of the practitioner's eyes and thus allows the practitioner to simultaneously view the screen and the procedure area. The primer aim of this study is to evaluate the success rate and anesthesiologist's satisfaction between two practitioners with different levels of experience in radial artery catheterization with smart glasses USG. The secondary aims are to evaluate the cannulation time and complications between groups.

120 patients \>18 years who would be undergone elective elective surgery with an indication for radial artery catheterization between August 2022 and December 2022 were included to the prospective, randomised, single centre study. Patients underwent radial artery catheterization for any reason in the last one month, and with contraindications for catheterization were excluded. Patients were divided randomly into two groups (Group I: patients underwent radial artery catheterization using standart USG, and Group II: patients underwent radial artery catheterization using smart glasses integrated UGG). The catheterization was performed by two anesthetists with different experience. The subcutaneous distance, radial artery depth and diameter in short axis, cannulation time and ergonomic satisfaction of the practitioners were recorded. The program SPSS 11.5 was used to analyze data.

Eligibility Criteria:
Inclusion Criteria:

* \>18 years who would have undergone elective elective surgery with an indication for radial artery catheterization between August 2022 and December 2022

Exclusion Criteria:

* Patients who underwent radial artery catheterization for any reason in the last 1 month and with contraindications for catheterization
Mayo Clinic IBD Biobank

Researchers are collecting and storing blood, stool, and urine samples and medical information to better understand Inflammatory Bowel Disease (IBD) to improve disease outcome.

Subjects will be sent a letter detailing the proposed biobank and soliciting enrollment. Following the informed consent process, subjects will provide a blood sample (50 ml), urine sample (50 ml), and stool. The blood and urine samples will either be collected at the one of the Mayo Clinic outpatient laboratories or by a mail-out kit. Subjects will be asked to complete a questionnaire and 24-hour food recall questionnaire (completed online).

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with inflammatory bowel disease (IBD) who are between the ages of 18 and 85 at time of study enrollment.
* The diagnosis of IBD will be based on the standard IBD criteria including biochemical and colonoscopy screening.
* Women with inflammatory bowel disease of childbearing potential and pregnant women will be offered enrollment because there is no risk to an unborn child in this investigation.
* Patients between the ages of 18 and 85 without history of IBD or colon cancer.

Exclusion Criteria:

* Patients with known liver disease.
* Patients unable to provide informed consent.
* Prisoners and institutionalized individuals.
* Patients with a history of colorectal cancer.
Evaluation of a Noninvasive Fetal RHD Genotyping Test

This study will collect whole blood samples from pregnant subjects who are RhD negative by serology to develop an assay for RHD determination of the fetus.


Eligibility Criteria:
Inclusion Criteria:

* Subject is 18-64 years of age
* Subject is female
* Subject is pregnant
* Subject is RhD negative
* Subject is between 10 and 28 weeks gestation
* Subject provides informed consent
* Subject agrees to provide neonatal RHD and sex outcome

Exclusion Criteria:

* None
Quinagolide Vaginal Ring on Lesion Reduction Assessed by MRI in Women With Endometriosis/Adenomyosis

This will be a randomized, double-blind, placebo-controlled, proof-of-mechanism phase 2 trial investigating the effect of quinagolide extended-release vaginal ring on reduction of lesions assessed by high-resolution magnetic resonance imaging in women with endometrioma, deep infiltrating endometriosis, and/or adenomyosis.


Eligibility Criteria:
Inclusion Criteria:

1. Pre-menopausal women between the ages 18-45 years (both inclusive) at the time of signing the informed consent
2. Body mass index (BMI) of 18-35 kg/m2 (both inclusive) at screening
3. Confirmation of deep infiltrating endometriosis (DIE), endometrioma or adenomyosis by high-resolution MRI at screening
4. Transvaginal ultrasound (TVU) documenting a uterus with no abnormalities of endometrium and presence of at least one ovary with no clinically significant abnormalities at screening. Note that presence of uterine fibroids are not exclusionary but presence of any submucosal fibroids or polyps are exclusionary
5. Willing and able to use a non-hormonal single-barrier method (i.e. condom) for contraception from the start of screening to the end-of-treatment. This is not required if adequate contraception is achieved by vasectomy of the male sexual partner, surgical sterilisation (e.g. tubal ligation and blockage methods such as ESSURE) of the subject, or true abstinence of the subject (sporadic sexual intercourse with men requiring condom use)
6. Willing to avoid the use of vaginal douches or any other intravaginally administered medications or devices (except for tampons) from randomization to the end of treatment

Exclusion Criteria:

1. Use of depot medroxyprogesterone acetate (MPA) within 10 months prior to the screening visit.
2. Use of gonadotropin-releasing (GnRH) agonists (3-month depot) or dopamine agonists within 6 months prior to the screening visit.
3. Use of GnRH agonists (1-month depot or nasal spray), GnRH antagonists, aromatase inhibitors, danazol, birth control implants (e.g. NEXPLANON), progestogen or levonorgestrel releasing intrauterine device (IUD) within 3 months prior to the screening visit.
4. Use of hormonal contraceptives (including combined oral contraceptive pill, transdermal patch, and contraceptive ring) within 1 menstrual cycle prior to the screening visit.
5. Contraindications to MRI such as having internal/external metallic devices and/or accessories (e.g. cardiac pacemakers and leg braces)
A Study of OSI-7904L as Treatment in Patients With Head and Neck Cancer Who Have Failed First-Line Therapy

Multi-center, Phase II study to evaluate the efficacy and safety of OSI-7904Lin head and neck cancer in patients who have failed first-line therapy


Eligibility Criteria:
Inclusion Criteria:

Histologically or cytologically confirmed metastatic or locally recurrent SCCHN that is incurable with surgery or radiation therapy ECOG performance status 0-2 No more tha 1 prior chemotharapy regimen for metastatic or locally recurrent disease Adequate bone marrow, Hepatic and renal function. At least one target lesion greater than or equal to 20 mm.

Exclusion Criteria:

Symptomatic brain metasteses which are not stable, are not adequately controlled, are potenially life threatening or required radiation in the last 28 days Pregnant or lactating women. Concurrent anticancer therapy or other investigational drugs Patients with active or uncontrolled infections or other serious illnesses or medical conditions.
A Cohort Study With 100 Subjects Having a Primary Total Knee Replacement, Taking Pradax Post Discharge for Ten Days

Currently standard of care for preventing blood clots in total knee replacement patients is the drug Fragmin which is a daily injection for 10 days after surgery. Patients are in hospital for 3 to 5 days after total knee replacement surgery and patients are taught in hospital to do their injections.

The investigators would like to introduce the drug Pradax. Pradax is a Health Canada approved once a day, oral drug that may prevent blood clots in the patient's leg. In this study the patient will receive the standard of care injection drug Fragmin while in hospital but on discharge home the patient will take the oral drug Pradax daily (2 tablets 110mg) for 10 days.

We will enroll one hundred patients who are scheduled to have a total knee replacement. If you have signed the consent form for this study you will receive the standard of care treatment for blood clots, which is a daily injection drug called Fragmin. On the day of discharge from hospital study patients will receive a ten day supply of oral Pradax. to be taken once a day. The Orthopaedic research coordinator will call the study patients at post discharge day three and five to check on compliance and or concerns. All total knee replacement patients whether in study or not are seen in the Orthopaedic clinic at post op day 10 for staple removal and again at the 6 week point, 3 month, and 6 month and 1 year point. Standard of care x-rays are done also at these visits.

Eligibility Criteria:
Inclusion Criteria:

* Patients are eligible for the study if they are adult age, being greater than 18 years of age and less than 95 years of age. They must have the indications for a total knee replacement and have sufficiently passed the medically necessary tests by their surgeon to warrant total knee replacement.

Exclusion Criteria:

* Patients with active bleeding, or high risk of bleeding that contra-indicates the use of Pradax
* Renal or liver contra-indication necessitating adjustments of its dose.
* Clinically significant liver disease,
* Concomitant use of Proteus Ace inhibitors
* The use of the human immunitive deficiency virus
* The use of fibrinolynic agents
* Planned intermittent pneumatic compression or requirement of ongoing anticoagulation therapy
* Pregnancy
* Breast-feeding.
Cerebral Oxygenation and Neurological Outcomes FOllowing CriticAL Illness

Purpose of the Study Critical illness requiring life support affects over 150 000 people in Ontario every year. With aggressive support, the number of people who die from critical illness is decreasing. However, people who survive often have neurological problems. These neurological problems often include difficulties with memory, concentration, and attention. These problems are associated with poor quality of life among survivors of critical illness. The aim of this study is to identify the factors that contribute to these neurological deficits. Specifically, the investigators are testing whether changes in oxygen delivery to the brain during critical illness are related to both short- and long-term neurological complications.

Procedures involved in the Research When patients are diagnosed with a critical illness such as shock or respiratory failure, they are treated with intravenous fluids, medications to raise their blood pressure, and can be placed on a ventilator to assist with their breathing. They are observed in an intensive care unit (ICU). This research protocol does NOT interfere with the normal treatment of patients with critical illness. The procedure involved in this research protocol requires the placement of two stickers to either side of the patient's forehead, and information about oxygen delivery to the brain will be recorded. When the patient has recovered from the critical illness, they will be asked to perform several neurological tests. Some of these tests will be done with a pencil and paper, while others will use a robotic device to test arm movements, reaction time, and concentration.

Potential Harms, Risks or Discomforts:

This research study involves the placement of a sticker sensor to either side of the forehead. Rarely, patients may develop a rash to these electrodes. The investigators monitor patients very carefully for rashes, and if a rash is to occur, the sticker sensor will be removed. With regards to the neurological testing, rarely patients can have some mild muscle stiffness after moving their arms in the robot. The investigators do not expect any other further harms, risks, or discomforts.

A detailed protocol is currently under review for funding at Physician Services Incorporated, and can be included pending decision.

Eligibility Criteria:
Inclusion Criteria:

* Critically ill patients defined as having either:

  1. Respiratory failure: Defined as invasive mechanical ventilation for a predicted duration of \>24 hours, or:
  2. Shock: Defined as being on one of the following agents:
* norepinephrine (\>5 mcg/min) IV
* epinephrine (at any dose)
* vasopressin (in combination with another pressor)
* milrinone (in combination with another pressor)

Exclusion Criteria:

* expected survival \<24 hours
* history of cognitive dysfunction
* unable to participate in follow up testing
Trial to Assess Chelation Therapy (TACT)

The purpose of this study is to determine the safety and effectiveness of ethylene diamine tetra-acetic (EDTA) chelation therapy in individuals with coronary artery disease.

EDTA chelation therapy involves repeated administrations of a synthetic amino acid to reduce atherosclerotic plaque and other mineral deposits throughout the cardiovascular system.

Participants will be randomly assigned to receive 40 infusions of either the standard chelation solution or placebo. The primary endpoint of this trial will be a composite of all cause mortality, myocardial infarction, stroke, coronary revascularization, and hospitalization for angina.

The results of TACT will provide either a significant positive result or an informative null result upon which rational clinical decision-making and health policy can be based.

Eligibility Criteria:
Inclusion Criteria for Participants:

* Heart attack at least 6 weeks prior to study start

Exclusion Criteria for Participants:

* Serum creatinie level greater than 2.0 mg/dL
* Platelet count less than 100,000/µL
* Blood pressure greater than 160/100
* Chelation therapy within 5 years prior to study start
* History of allergic reactions to EDTA or any of the therapy's components
* Coronary or carotid revascularization procedures within 6 months prior to study start or a scheduled revascularization
* Cigarette smoking within 3 months prior to study start
* Childbearing potential
* History of liver disease
* Active heart failure or heart failure hospitalization within 6 months.
* Diagnoses of additional medical conditions that could otherwise limit patient survival
* Inability to tolerate 500-mL infusions weekly.
Investigating the Effect of Ocrelizumab in African Americans and Caucasians With Relapsing Multiple Sclerosis

The investigators intend to examine the effects of ocrelizumab use in African American multiple sclerosis disease course compared to Caucasian disease course utilizing imaging measures with magnetic resonance imaging (MRI) and optical coherence tomography angiography (OCT-A)..

Multiple sclerosis (MS) is a disease of the central nervous system (CNS). Several lines of evidence suggest that MS is an autoimmune disease with both T and B-cell activity leading to CNS inflammation which results in demyelinating injury. Ocrelizumab was FDA approved in March 2017 for relapsing remitting (RRMS) and primary progressive multiple sclerosis (PPMS) by depleting B cells. It has shown to be effective in reducing the annualized relapse rate, decreasing disability progression, and reducing the number of new and active MRI brain lesions.

Previous research studies have reported a more aggressive course in African Americans with MS, more lesions on the MRI scan, and more severe injury to layers of the eye (specifically in the retina) compared to Caucasians.

This is a novel study investigating the effect of ocrelizumab in African American relapsing multiple sclerosis (RMS) patients compared to Caucasian RMS patients using imaging measures, specifically multimodal magnetic resonance imaging (MRI) and optical coherence tomography-angiography (OCTA). This is a non-drug intervention study; therefore, patients who are recruited will have already decided to make ocrelizumab their disease-modifying therapy before enrollment. The study will recruit 86 (including 6 potential screen fails) patients in total (40 African American patients and 40 Caucasian patients who are matched by age, sex, disease duration, and disease disability. The study will consist of 5 visits in six-month intervals across two years.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who have chosen to start ocrelizumab and for whom ocrelizumab is determined to be the most appropriate standard-of-care disease modifying therapy (DMT) by the treating neurologist.
2. May be treatment naive, or had suboptimal response to no more than one DMT after an adequate course of treatment (defined as treatment duration of 6+ months).
3. Age 18 to 60 years old.
4. Ethnicity: self-identified as African American or Caucasian.
5. Clinically definite relapsing remitting multiple sclerosis (RRMS) per 2017 revised McDonald criteria.
6. EDSS from 0 to 6 (inclusive) at baseline visit.
7. Able to give informed consent.
8. Able to have MRI scans.

Exclusion Criteria:

1. Treatment with another monoclonal antibody, including but not limited to natalizumab, alemtuzumab, daclizumab.
2. Failed 2 or more DMTs.
3. Treatment with immunosuppressant agents, such as chemotherapeutic agents.
4. Claustrophobia.
5. Allergy to contrast.
6. Significant medical problems that the PI determines will interfere with the conduct of the study.
7. Relapse or use of corticosteroids within 30 days prior to baseline visit.
8. Pregnancy.
9. History of kidney or liver insufficiency.
10. History of malignancy.
Optimizing Duration of Therapist-guided Internet-delivered Cognitive Behaviour Therapy

Depression and anxiety are common and prevalent conditions that are frequently under treated. In an attempt to increase timely and accessible psychological treatment, Internet-delivered Cognitive Behaviour Therapy (ICBT) has emerged. ICBT involves delivering therapeutic content to manage depression and or anxiety via structured online lessons. This is often combined with brief therapist guidance, for example once per week for 8 weeks via secure messaging or phone calls. Although outcomes of ICBT are very impressive, there is room for improvement in terms of completion rates and outcomes. Feedback from patients suggest that some patients would prefer longer term support or follow-up care.

In this two-factorial randomized controlled trial, the investigators aim to contribute to the literature by examining whether the efficacy of ICBT is improved by offering an extended period of support to clients (from 8 weeks to 12 weeks) and being offered a booster session at 16 weeks after treatment enrollment (yes vs no). Follow-up assessments will be conducted at 8, 16 and 26 weeks after treatment enrollment. Primary outcomes are reduced anxiety and depression. Secondary outcomes include reduced panic, social anxiety, trauma, quality of life, disability, work productivity, and healthcare use.

Past research of ICBT offered in routine care has found that patients and therapists often recommend "personalizing" the delivery of ICBT, for example, by increasing the length of time therapist support is available or offering booster sessions after treatment has ended. To date, in terms of ICBT, there has been limited research on the impact of extending support after treatment materials have been delivered or offering a booster session.

In this trial, the investigators will examine if the efficacy of ICBT is improved by offering an extended period of support to clients (from 8 weeks to 12 weeks) or by being offered a booster session at 16 weeks after treatment enrollment (yes vs no). Follow-up assessments will be conducted at 8, 16 and 26 weeks after treatment enrollment. Primary outcomes are reduced anxiety and depression. Secondary outcomes include reduced panic, social anxiety, trauma, quality of life, disability, work productivity, and healthcare use. The impact of these factors on intervention usage (e.g., completion rates, log-ins, emails sent) and treatment satisfaction will also be examined.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Endorse symptoms of anxiety or depression
* Resident of Saskatchewan
* Access to a computer and the Internet

Exclusion Criteria:

* Have a severe psychiatric illness (e.g. psychosis)
* Assessed as being at high risk of suicide
* Report severe problems with alcohol or drugs
* Report severe cognitive impairment