cyrilzakka/clinical-trials huggingface dataset:
In Situ Simulation Training in Lifeguard Organisations

This retrospective study will analyse a dataset consisting of 919 in situ simulation assessments collected between 2018 and 2023 in a Danish nationwide surf lifeguard organisation. The primary objective is to estimate the pass/fail ratio of in situ simulation assessments. The secondary objective is to analyse risk factors associated with a failed assessment. These results may guide future efforts to improve the Danish surf lifeguard training program.

Background: Once weekly on all lifeguard-supervised beaches during the summer holiday period, a lifeguard instructor sneaks undetected into the primary surveillance zone between the flags and raises a hand to indicate a drowning scenario. This is called in situ simulation and is used to assess Danish surf lifeguards' rescue and medical skills. It is an unannounced test occurring during working hours, followed by feedback and training with the lifeguard instructors. Previous data indicate that approximately 1 in 5 lifeguards fail the in situ assessment. Analysing data from in situ simulation assessments may pinpoint areas for future improvement.

Objectives: The primary objective is to estimate the pass/fail ratio of in situ simulation assessments. The secondary objective is to analyse risk factors associated with a failed assessment. These results may guide future efforts to improve the Danish surf lifeguard training program.

Methods: This retrospective study will analyse a dataset consisting of 919 in situ simulation assessments collected between 2018 and 2023 in a Danish nationwide surf lifeguard organisation. Data on the local conditions (e.g., wave height, time of the day, and the number of beach visitors) and the in situ evaluation (pass/fail) were extracted directly from the predefined variables. Data on failure reasons were extracted through manual validation of the semi-structured free text fields by four independent observers. Any discrepancies were resolved by a senior member of the research group.

Eligibility Criteria:
Inclusion Criteria:

* All in situ assessments in the nationwide Danish lifeguard organisation from 2018 to 2023.

Exclusion Criteria:

* Blank entries
* Dublets
Cotinine Metabolism in Infants and Children

Levels of cotinine, a biomarker for nicotine, have been found to be higher in infants and small children than adults. This pharmacokinetic study is designed to determine whether children metabolize cotinine differently than adults.

Seventy-two healthy children between the ages of 2 months and 6 years will come with their mothers to SFGH GCRC for one approximately 9 hour visit. After being examined by a pediatrician, the child will be administered one dose of cotinine at .05 mg/kg.

Saliva and urine samples will be collected prior to dosing and throughout the day to characterize the metabolism and excretion of cotinine. The investigators have previously shown that a ratio of 3'-hydroxycotinine/cotinine (3HC/Cot) in saliva correlates closely to nicotine metabolism.

Following these one day hospital visits, a research assistant will visit the participants in their homes to collect urine and saliva samples at 1,2,3,7, and 10 days after the initial dose.

The long-term goal is to characterize developmental changes in CYP2A6 activity and nicotine and cotinine metabolism in infants and children. Our hypotheses are:

* The rate of nicotine and cotinine metabolism and the level of CYP2A6 activity will increase with age throughout infancy and childhood.
* The rate of cotinine glucuronidation (reflecting UGT 1A4 and 1A9 activity) will increase with age.
* Cotinine clearance will be lower and cotinine half-life longer in African-Americans compared to Caucasians.
* The excretion of cotinine glucuronide will be less among African-Americans compared to Caucasians.
* Developmental increases in CYP2A6 will be greatest in children with wild type CYP2A6 genes, and will be lower in children who have CYP2A6 gene variants associated with reduced activity.

This present study is the first step in the investigation of the above hypotheses. The primary goal of this study is to determine if there are age-related changes in cotinine clearance and validate the 3HC/COT ratio as a biomarker of cotinine clearance and half-life. This biomarker can then be used in larger studies to explore the hypotheses described above. The biomarker could also be used in epidemiologic studies of the health effects of SHS in infants and children.

Primary Specific Aims:

1. Determine the following in infants and children between 2 and 84 months of age dosed with deuterium-labeled cotinine:

   * The clearance of cotinine
   * The half-life of cotinine
   * The volume of distribution of cotinine
2. Validate the 3HC/Cot ratio in saliva and in urine as a marker of cotinine clearance and half-life.

   Secondary Specific Aims:
3. Determine the effects of age on the cotinine metabolite profile in the 8-hour urine sample.
4. Determine if sulfation is a conjugation pathway for cotinine in infants and young children.

Eligibility Criteria:
Inclusion Criteria:

* Ages: 12 months, 13-24 months, and 25-83 months
* Caucasian (including Hispanic) and African American only
* Some exposure to secondhand smoke

Exclusion Criteria:

* Any medical problems
* Taking prescription medication (there are exceptions)
Does the Invitation by the General Practitioner Improve Patients' Participation in Colorectal Cancer Screening?

The propose of this study is to assess the effect of general practitioner's involvement on first patients' solicitation in screening for colorectal cancer by testing for faecal occult blood (FOBT).


Eligibility Criteria:
Inclusion Criteria:

* Aged : 50 to 74 years.
* Not having ever been invited to participate in colorectal screening.

Exclusion Criteria:

* Patients who have a Fecal Occult Blood Test for less than 2 years or a colonoscopy within the past 5 years or excluded for medical reasons (according to information known from ADECA).
Effects of Insulin in Perceived Mood Symptoms in Patients With Type 2 Diabetes

This study investigates the influence of two different insulin regimens, twice-daily insulin lispro low mix (LM) and once-daily insulin glargine, on perceived physical, mood, and cognitive symptoms as well as cognitive-motor task performance in patients with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed as having type 2 diabetes mellitus, as defined by the World Health Organization
* Are being treated with metformin therapy alone, metformin therapy plus once-daily insulin, or metformin plus one or more other oral antihyperglycemic agents at the time of study entry
* Female patients not breastfeeding and female patients of childbearing potential must test negative for pregnancy at time of study entry based on a urine pregnancy test and do not intend to become pregnant during the study and agree to use a reliable form of birth control during the study
* Hemoglobin A1c greater than or equal to 7.0% and less than or equal to 10% within 3 months prior to visit 1
* Have given informed consent to participate in the study in accordance with local regulations

Exclusion Criteria:

* Are investigator site personnel directly affiliated with the study, or are immediate family of investigator site personnel directly affiliated with the study.
* Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry
* Have previously been diagnosed with clinical depression or have been treated with a central nervous system stimulant, antidepressant, antipsychotic, or anxiolytic agent within 30 days prior to study entry
* Have a known allergy to insulin lispro low mixture, insulin glargine, metformin hydrochloride, or excipients contained in these products
* Have known hypersensitivity or contraindication to metformin hydrochloride
Healthy Children, Healthy Families: Parents Making A Difference

The impacts of Healthy Children, Healthy Families: Parents Making a Difference! (HCHF) on how low-income parents enrolled in the Expanded Food and Nutrition Education Program use effective parenting practices to influence children's healthy eating and active play behavior will be investigated, as compared to a delayed intervention control group.

The Healthy Children, Healthy Families: Parents Making a Difference! (HCHF) curriculum is a Cornell curriculum for parents and caregivers focusing on the behaviors most likely to help children avoid unhealthy weight gain. These behaviors include drinking water or milk instead of sweetened beverages, eating more vegetables and fruits, playing actively, eating fewer high-fat and high-sugar foods, limiting screen time, and having sensible serving sizes. The 8-session curriculum uses a learner-centered dialogue approach, hands-on activities and role plays. The study will include 300 participants with young children 3-5 years old in Head Start and childcare programs in New York City using a randomized control design. In period 1 (9 weeks), half the groups will receive HCHF education (immediate education, IE) and half will serve as controls, receiving no education (delayed education, DE). In period 2 (9 weeks), DE will receive education; IE will receive no education and be followed longitudinally for periods 2 and 3. In period 3 (16 weeks), neither group will receive education and both will be followed longitudinally. Data will be collected at each time point using validated measures, including the HCHF Checklist developed by the investigators and complementary measures that assess parenting feeding practices, food behavior in parents, food behavior in children, and parent self-efficacy around obesity prevention behaviors. It is hypothesized that change pre- to post- HCHF will be greater than control groups, and changes in behavior will be retained post-education.

Eligibility Criteria:
* Inclusion Criteria: Parents/caregivers with young children 3-5 years old
* Exclusion Criteria: Any person who does not have children who are 3-5 years old
Remission Through Early Monitored Insulin Therapy - Duration Month

REMIT-DM is a feasibility pilot study where participants will be recruited soon after their diagnosis of type 2 diabetes to be placed immediately on insulin therapy for maximum of four weeks with titrations of insulin guided by glucose levels and trends provided by a continuous glucose monitor (CGM), with the purpose of achieving diabetes remission.

REMIT-DM is a feasibility pilot study that aims to show that previously published diabetes remission through early use and titration of short-term insulin therapy is possible and safe in the ambulatory diverse American population of patients with T2D, with continuous glucose level and trend information provided by CGM. We developed the algorithm based on published diabetes remission studies and include within the algorithm the CGM trend arrows to further refine insulin doses for both safety and efficacy purposes. Data captured by the CGM transmits automatically to the cloud and is accessible at any time of day by the multidisciplinary diabetes team, which includes the certified diabetes educator (CDE) and Endocrinologist. The CGM-guided insulin titration algorithm is designed to achieve euglycemia (defined as fasting CBG \< 100 mg/dL, and 2 hour post-prandial CBG \< 120 mg/dL) within 2 weeks of initiating insulin therapy, then to help maintain euglycemia for 2 weeks before discontinuing insulin entirely. Ten participants will undergo a maximum of 4 weeks of insulin therapy and will be assessed for remission afterwards to confirm enough recovery of beta cell function. (Complete remission is defined as fasting glycemia \<100 mg/dL without use of pharmacological therapy.) Afterwards, we will implement American Diabetes Association (ADA) guidelines for standard glycemic management, as necessary. We will use the data collected during this feasibility study to sharpen the CGM-guided insulin titration algorithm for creation of a T2DM remission mobile application that could then be tested and studied in a larger sample size.

The feasibility study will also take into account clinically meaningful data points e.g. the number of phone calls between the patient and the diabetes team, the patient experience, and patient satisfaction.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18
2. A1C criteria - \>7.0
3. Newly diagnosed with T2D within 4 years
4. Lifestyle controlled
5. Subject may be on up to 2 medications for diabetes.
6. Smart phone or home computer compatible with DEXCOM CLARITY software
7. English speaking
8. Assessed by endocrinologist and diabetes educator to be able to perform skills necessary for CGM use and insulin delivery

Exclusion Criteria:

1. Autoimmune Type 1 DM, defined as positive GAD65 or islet cell antibodies
2. Pregnant
3. Chronic Kidney Disease (CKD) Stage IV or greater
4. Mental and/or cognitive disorder (based on documented disorder and/or assessment of physician or educator)
5. No access to computer for downloading CGM
6. BMI \<18.0
Opinions and Representations of Advanced Practice Nurses (IPA) in Nephrology in France on Clinical Research

This single-center study will identify the representations and opinions of Advanced Practise Nurses (IPA) in nephrology in the Auvergne Rhône Alpes (AURA) region about clinical research. The study will consist of individual semi-directive interviews with Advanced Practise Nurses (IPA).


Eligibility Criteria:
Inclusion Criteria:

* Hold a state diploma in advanced practice nursing
* Have been working at the health facilities for at least 3 months
* Working in France

Exclusion Criteria:

- Refusal to participate in the study
Study Evaluating DVS-233 SR and Venlafaxine ER in Adult Outpatients With Major Depressive Disorder

To compare the antidepressant efficacy and safety of DVS-233 SR versus placebo in adult outpatients with MDD.


Eligibility Criteria:
Inclusion Criteria:

* Outpatients.
* Sexually active individuals participating in the study must use a medically acceptable form of contraception during the study and for at least 15 days after the last dose of test article
* Subjects must have a primary diagnosis of major depressive disorder

Exclusion Criteria:

* Treatment with DVS-233 SR at any time in the past
* Treatment with venlafaxine (immediate release \[IR\] or ER) within 90 days of study day 1
* Known hypersensitivity to venlafaxine (IR or ER)
Clinical Assessment of Urinary Antiseptics Methenamine and Methylthioninium in Recurrent Cystitis

This is a double-blind, randomized, double-dummy, comparative study in parallel groups of subjects presenting with recurrent cystitis (≥2 episodes within the past 6 months). Subjects will be randomized and treated with one of two presentations of urinary antiseptics containing methenamine and methylthioninium for three days, followed by three days of antibiotic therapy as determined by urine culture and antibiogram. This study aims to assess the efficacy and safety of each treatment.

This is a double-blind, randomized, double-dummy, comparative study in parallel groups of subjects presenting with recurrent cystitis (≥2 episodes within the past 6 months). After initial evaluations including urine culture and antibiogram, a total of 284 subjects will be randomized and treated with one of two presentations of urinary antiseptics containing methenamine and methylthioninium for six days. After three days of treatment, subjects will return to the study center and antibiotic therapy based on the results of the urine culture and antibiogram will be initiated for each subject, to be continued for the remaining three days of the treatment period. Efficacy assessments will include the UTISA (Urinary Tract Infection Symptoms Assessment Questionnaire) together with a global assessment by the investigator. Safety assessments will include monitoring of adverse events and laboratory tests carried out at each of the three study visits.

Eligibility Criteria:
Inclusion Criteria:

* Patients of both sexes, age ≥18
* Clinical diagnosis of recurrent cystitis (≥ 2 episodes in the past 6 months)
* Female subject of reproductive age not pregnant, agrees to use birth control during study period
* Subject has read, understood, signed and dated informed consent document

Exclusion Criteria:

* History of nephritis or kidney stones
* History of hepatic or gastrointestinal disease
* Diabetes
* Glaucoma
* Female subjects: pregnancy or breastfeeding
* History of anatomical alterations contributing to recurring cystitis on imaging exams
* Hypersensitivity to any component of study drug
Impact at One Year of a Secondary Prevention Educational Program on Cardiovascular Risk Factors

In secondary prevention, the beneficial role of cardiac rehabilitation programs after myocardial infarction, percutaneous coronary intervention or coronary artery bypass is now well established. The large majority of patients don't benefit from cardiac rehabilitation but for those who do, they usually follow an inhospital short health educational program with a sensibilisation to different coronary risk factors like smoking, overweight and inactivity. The impact of these inhospital short health educational programs combined to cardiac rehabilitation has never been totally evaluated, especially the impact on smoking cessation, weight loss and daily physical activity.

Therefore, the present study aims to evaluate the impact at one year on 400 consecutive patients' coronary risk profile of:

* an inhospital short health educational program alone
* an inhospital short health educational program combined to cardiac rehabilitation
* a cardiac rehabilitation program alone

Classical CV risk factors, quality of life, daily physical activity and energy expenditure, smoking dependency and a daily quantification of fat intake are assessed with previously validated self-administrated questionnaires. Further factors like the lipid profile and glycaemia (with HbA1c in case of diabetes) will also be assessed. These evaluation will take place once at the of the hospitalization for acute coronary events in all patients, once at the end of any of the three rehabilitation programs for the concerned patients and, finally, one year after the hospitalization or the end of the rehabilitation program (mailed questionnaires and biological check-up). At this time, smoking dependency, medication, body mass index, any coronary event or need of coronary revascularization along with the professional ongoing situation (return to work) will be investigated.

As this study aims to evaluate the efficiency of France's clinical practice in spotting most relevant risk factors, the results of the present study could help us to focus the medical and paramedical resources on the modification of specific relevant risk factors.

Eligibility Criteria:
Inclusion Criteria:

* acute coronary syndrome or myocardial infarcts

Exclusion Criteria:

* misunderstand the questionnaires
* living in institution
* severe morbidity
Comparison of SureCALL® EMG Labor Monitor® and Tocodynamometer to Intrauterine Pressure Catheter Measurement (IUPC) Measurement in Pregnant Women

This measurement study was designed to evaluate the performance of SureCALL® EMG Labor Monitor® (SureCALL®) to the predicate Tocodynamometer device (TOCO) using the performance of an Intrauterine Pressure Catheter device (IUPC) as the "gold standard".

The SureCALL® EMG Labor Monitor® (SureCALL®) is a transabdominal electromyography monitor intended to measure intrapartum uterine activity. It is intended for use on term pregnant women who are in labor, with singleton pregnancies, using surface electrodes on the maternal abdomen. The device is intended for use by healthcare professionals in a clinical setting.

This measurement study was designed to evaluate the performance of SureCALL® to the predicate Tocodynamometer device (TOCO) using the performance of an Intrauterine Pressure Catheter device (IUPC) as the "gold standard".

This study involved 20 women at term, in labor, at three clinical sites. Each study subject was instrumented with three technologies for measuring uterine activity:

1. a tocodynamometer attached to the maternal abdomen
2. a set of abdominal surface electrodes for uterine electromyography, and
3. an intrauterine pressure catheter.

Using IUPC as the "gold standard", this study methodology allowed a three way comparison for evaluating how well the SureCALL® system performed compared to the TOCO technology.

Eligibility Criteria:
Inclusion Criteria:

* Singleton Pregnancy
* Indicated for IUPC
* Gestational ages from 37 to 41 weeks
* Informed consent required

Exclusion Criteria:

* Multifetal Pregnancy
* Not Indicated for IUPC
* Gestation ages below 37 or above 41 weeks
* Informed consent not given
Evaluation of Clear Aligner Trays to Straighten Teeth

The objective of this study is to evaluate the efficacy of Clear Aligners to correct tooth malocclusions with the use of attachments and/or buttons, as determined by the amount of teeth movement and overall achievement goals of the treatment plan.

This is a prospective, multi-center study with a maximum duration of 24 months or longer depending on refinements, to assess the safety and efficacy of 3M Clear Aligners, with the use of attachments to correct teeth malocclusions.

The subject population for this study will be male and female subjects ≥ 14 years of age. Subjects who meet the inclusion and exclusion criteria will be asked to participate in the study. Up to a total of 180 subjects may be enrolled at up to 12 different clinical research sites, (up to 15 subjects per site).

The subjects will undergo a target of up to 24 months (or longer depending on refinements) of treatment to align the teeth to the planned target. Subjects will wear the Clear Aligners for at least 22 hours per day, with the exception of consumption of meals and beverages, with the exception of water, which can be consumed while wearing the aligners. During each 6-week period between follow up visits, subjects will wear each set of Clear Aligners for 2 weeks, in the order indicated per the Orthodontists treatment plan.

Eligibility Criteria:
Inclusion Criteria:

1. Subject is at least 14 years of age.
2. Subject is willing and able to give informed consent.
3. Subject is willing to be digitally scanned at each 6-week visit, including after application of attachments.
4. Subject has a need for single or double arch orthodontic treatment with a target duration of 18 months or less.
5. Subject has good oral hygiene defined by the orthodontist.
6. Subject has only permanent dentition.

Exclusion Criteria:

1. Subject has skeletal discrepancies requiring surgery
2. Subject is undergoing active dental work
3. Subject has severe open bite \> 2 mm
4. Subject has severe overjet \> 4 mm
5. Subject has deep bite \> 3 mm
6. Subject has over crowding per arch \> 4 mm
7. Subject has dental prostheses/implants that will interfere with projected teeth movement
8. Subject is taking systemic steroid medication
9. Subject is taking Biphosphonates or any other medication for treatment of osteoporosis