cyrilzakka/clinical-trials huggingface dataset:
Computerized Alcohol Screening for Children and Adolescents

The goal of this project is to develop a computerized screening program for primary care offices that is based on the NIAAA's Alcohol Screening Guide for Children and Adolescents and assess its psychometric properties among nine- to 18-yr-old primary care patients. There have been few studies of alcohol screening and brief intervention conducted among adolescents receiving primary medical care. This project will develop and validate a new computerized Alcohol Screening for Children and Adolescents (cASCA) system based on the two age-specific screening questions of the NIAAA Guide and includes the CRAFFT and AUDIT as secondary risk and problem assessments. The system will yield a provider report with the screening results, level of risk, and recommended brief advice, counseling, or referral strategies. The Specific Aims of this project are to: 1)Assess the sensitivity, specificity, positive and negative predictive values of the 'any drinking/number of drinking days' and 'friends' questions of the cASCA in identifying past-year use as determined by the Timeline Follow-Back Calendar (TLFB), and for identifying any problem use, abuse or dependence as determined by the AUDIT, CRAFFT and a structured psychiatric diagnostic interview (computerized DISC-IV, Youth Version) at baseline (criterion validity); 2)Assess the test-retest reliability of the cASCA in measuring drinking frequency categories and in classifying patients into Low, Medium and High risk categories; 3)Assess the predictive validity of the 'any drinking/number of drinking days' and 'friends' questions in predicting drinking, "binge" drinking, and any problem use, abuse or dependence at 12-mos follow-up; 4)Assess the degree to which the 'any drinking/number of drinking days' item of the cASCA predicts drug use risk as measured by the TLFB (any use and frequency), tobacco use as measured by the Hooked on Nicotine Checklist (screen for potential nicotine dependence), drug use disorders as measured by the Drug Abuse Screening Test for Adolescents, and the degree to which it predicts other mental health problems as measured by the Youth DISC Predictive Scales at baseline and 12-month follow-up; 5)Compare the psychometric properties of the cASCA across subgroups, including: age, gender, race/ethnicity, practice type, provider type, and patient risks (e.g., those with/without friends who drink); and explore the possible effects of the cASCA system on drinking at 3-, 6-, 9-, and 12-month follow-ups.


Eligibility Criteria:
Inclusion Criteria:

* nine- to 18-years old
* arriving for non-emergent care
* have an email address and internet access
* provide informed assent/consent.

Exclusion Criteria:

* unable to read or understand English
* living away at college at the time of the recruitment visit
* not available for computer/telephone follow-ups
* judged by the provider to be medically or emotionally unstable at time of visit.
Short-term Effect of COVID-19 Vaccine on Blood Pressure

To investigate short-term effect of COVID-19 vaccination on blood pressure by conducting 24-hour ABPM

Safety of coronavirus disease 19 (COVID-19) vaccines has been a concern. Despite safety profile of different vaccines demonstrated in phase 2/3 trials, there has been evolving evidence on adverse effects of some particular COVID-19 vaccines. One of the mostly known example is vaccine-induced thrombotic thrombocytopenia (VITT). Apart from the thrombotic risk of ChAdOx1 nCoV-19 vaccine, there has been studies providing the preliminary data on effect of mRNA-based COVID-19 vaccine on blood pressure.

A case series report was published on Hypertension in June 2021 on documented stage III hypertension within minutes of vaccination (mRNA vaccines) in a vaccination centre located in Switzerland. The study reported 9 subjects experienced a surge in blood pressure to stage III hypertension after vaccination. Yet the study had a few shortcomings. There was not baseline measurement of blood pressure. Surge of blood pressure shortly after vaccination could be due to nervousness or white coat effect. Thus surge of blood pressure within minutes of vaccination could be not due to vaccination. There was not long-term follow-up on blood pressure measurement after vaccination.

Further to the case series report, another prospective study in Italy investigated effect of mRNA vaccine on blood pressure and heart rate. The study was conducted as a survey. There was 5.3% of respondents (6/113) reported rise of home blood pressure of at least 10mmHg after 1st dose vaccination, compared with home blood pressure prior to vaccination. Among these subjects, 4 of them required anti-hypertensive medication intensification.

Yet there remains lack of evidence and detailed description on effect of COVID-19 vaccines and blood pressure before and after vaccination. Use of ambulatory blood pressure monitoring (ABPM) before and after vaccination helps to understand the details on short-term blood pressure changes.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who will be receiving COVID-19 vaccination
* Subjects who understand Chinese to make an informed consent

Exclusion Criteria:

* Skin condition around the cuff not suitable for long term cuff wearing (e.g. severe dermatitis, wound)
Phase I Study Evaluating The Safety And Efficacy of a Device for Collection of Electrical Bioimpedance Data

The objectives of this study are to evaluate the safety and initial efficacy of the epidural injection procedure when combined with real-time multi-frequency bio-impedance measurements that collect data on the electrical bioimpedance characteristics of living human tissue on the path of the epidural needle.


Eligibility Criteria:
Inclusion Criteria:

1. Male or females 18 - 60 years of age
2. Imaging spine study (CT or MRI) in previous 3 months.
3. American Society of Anesthesiologists (ASA) class I-III
4. Patients undergoing elective standard pain relief treatment of Epidural Steroid Injection
5. Patients must be willing to participate in the study, and provide written informed consent
6. Women of child bearing potential must have a negative pregnancy test during the screening and baseline visits or the patient must be surgically sterile or be at least one year postmenopausal
7. Women of child-bearing potential must be using a medically acceptable method of birth control throughout the study such as: bilateral tubal ligation or the use of either a contraceptive implant, a contraceptive injection, an intrauterine device, or an oral contraceptive that has been taken for at least three months, which the subject agrees to continue using during the study, or a double-barrier method which must consist of a combination of any two of the following: diaphragm, cervical cap, condom or spermicide.

Exclusion Criteria:

1. Any contraindications for epidural injection
2. Patient with severe scoliosis
3. Previous spinal surgery, or any additional surgical intervention in the level of epidural injection other than elective standard pain relief treatment of Epidural Steroid Injection.
4. Documented, known or per examination neurological deficiency in lower extremities.
5. Pregnant or breastfeeding patients
6. Patients who have participated in another study within 30 days of enrolment
7. Investigator's opinion that the patient is medically unfit or would be at major risk if enrolled into the study i.e. known coagulopathy or recent use of anticoagulants or anti aggregates.
8. Presence of fever, sepsis or infection near the point of insertion or an infection in the bloodstream which may "seed" onto the catheter
9. Patients with known Hypovolemia
10. Any known Anatomical abnormalities, such as spina bifida, meningomyelocele or scoliosis
11. Patient suffering problems of the central nervous system, including multiple sclerosis or syringomyelia
12. Patients with identified heart-valve problems
13. Patients excessively hirsute where the surface electrodes are to be placed that are unwilling to shave these areas.
A Randomised Proof-of-Principle Trial Investigating Pharmacodynamics, Pharmacokinetics, and Safety of NNC0143-0406 in Subjects With Type 1 Diabetes Mellitus

This trial is conducted in Europe. The aim of this trial is to investigate Pharmacodynamics (the effect of the investigated drug on the body) , Pharmacokinetics (the exposure of the trial drug in the body), and Safety of NNC0143-0406 in Subjects with Type 1 Diabetes Mellitus


Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 18-55 years (both inclusive) at the time of signing informed consent
* Subjects diagnosed (clinically) with type 1 diabetes mellitus at least 365 days prior to the day of screening
* Treated with continuous subcutaneous insulin infusion at least 90 days prior to the day of screening

Exclusion Criteria:

* Known or suspected hypersensitivity to trial product(s) or related products
* Males who are sexually active and not surgically sterilised (vasectomy or otherwise) and their partners that are not using a highly effective contraception method, from randomisation until 90 days after dosing, such as double barrier contraception (e.g. condom and spermicide) or combination of either an oral ontraceptive, a contraceptive patch, a diaphragm or intrauterine device, together with a physical barrier such as condom. Male subjects must also agree to refrain from sperm donation from randomisation until 90 days after last dosing
* Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods (adequate contraceptive measures as required by local regulation or practice) (adequate contraceptive measures are defined as sterilisation, hormonal intrauterine device, oral contraceptives, condom with spermicide sexual abstinence or vasectomised partner)
Stress Reactivity of Physical Stressor on Depression

Depressive elderly individuals have showed higher basal level of cortisol and lower level of dehydroepiandrosterone (DHEA). Moreover, changes on these hormone levels have also observed in reactivity of an acute stress, such as physical exercise. On the other hand, physical training can modulate the release of these hormones. Therefore, depressive elderly individuals physically actives might show attenuated reactivity of an acute physical stressor compared to sedentary elderly individuals. The aim of these study is to compare the effect of an acute physical stressor on cortisol levels in depressive and healthy individuals, physically actives and sedentaries. Additionally, the sulfated form of DHEA (DHEAS) serves as a reservoir for DHEA, because of that it is expected that DHEAS levels might reduce after the acute physical exercise.

Depressive and healthy individuals were submitted to one session of 30 minutes of physical exercise of moderate intensity. Before and soon after the exercise it was collected saliva - to analyse cortisol and DHEAS hormones - and some psychological and physical aspects were also collected, such as anamneses, scales of anxiety, temperaments, mood, stress and quality of life. Moreover, during exercise heart rate and mood scale were assessed. To evaluate the reactivity and recovery of physical stressor (physical exercise) saliva tubes and psychological scales were collected 30 minutes and 45 minutes after the end of exercise.

Eligibility Criteria:
Inclusion Criteria:

* Age above of 60 years old
* Clinical diagnostic of depression

Exclusion Criteria:

* Hormonal replacement
* Physical disease
* Fasting
Safety of Percutaneous Tracheostomy in Clopidogrel and Selective Serotonin Reuptake Inhibitors

Safety of Percutaneous Tracheostomy in Clopidogrel and Selective Serotonin Reuptake Inhibitors

We propose a retrospective review of our experience with bleeding complication in the presence of antiplatelet and SSRI therapy and compare the complications with those who were not on antiplatelet agents or SSRI.

Eligibility Criteria:
Inclusion Criteria:

* on antiplatelet therapy or selective serotonin reuptake inhibitors(SSRI)

Exclusion Criteria:

* N/A
Effects of Dietary Ingredients on Vascular Function

The main aim of the study is to investigate the effects of dietary ingredients (polyphenols and carotenoids) on vascular function during acute glucose load. Each subject will receive 4 weeks of intervention with test product or placebo product after a dietary restriction run-in period of 14 days. Subjects will be challenged with an oral glucose tolerance test (OGTT) immediately after the run-in phase and at the end of the intervention phase. During the OGTT, blood samples will be taken at regular intervals.

The study will be conducted in subjects with impaired glucose tolerance.


Eligibility Criteria:
Inclusion Criteria:

* Males or females confirmed with IGT;
* Age ≥ 35 and ≤ 65 year at screening;
* Body Mass Index (BMI) \> 25 and \<40 kg/m2;
* Reported intense sporting activities ≤ 10h/w;
* Reported alcohol consumption ≤ 14 units/week (female volunteers) or ≤ 21 units/week (male volunteers)
* Currently not smoking and being a non-smoker for at least six months

Exclusion Criteria:

* Any medical condition or use of over-the-counter and prescribed medication which might affect study measurement (judged by the study physician);
* No reported participation in another nutritional or biomedical trial 3 months before screening;
* Reported weight loss or gain of 10% or more during a period of 6 months prior to screening;
* Anti-hyperglycemic drug or other medication which interferes with study measurements;
* No blood donation 1 month prior to screening;
* Reported allergy or intolerance to test products or other food products provided during the study;
Emergency Home Delivery. Learning Skills for Medical Doctors and Nurses. Kirkpatrick Levels of Learning

Mannequin training for emergency home delivery on medical doctors and nurses

two groups will be exposed to frontal lecture and simulato scenario on emergency home birth. After the first training a debriefing will be done. Following a second scenario will bi performed. All participants will complete a google form questionnaire before and after addressed to understand the value of their participation.

Eligibility Criteria:
Inclusion Criteria:

* medical doctors and nurses

Exclusion Criteria:

* none
Multi-Component Early Intervention for Socially Inhibited Preschool Children

This project is intended to provide a rigorous test of the Turtle Program, an early intervention program for behaviorally inhibited preschoolers. The proposed project will extend promising pilot study findings by: (a) evaluating the integrated intervention in a larger sample (n = 150) of 45-64 month children and their parents, which will allow for an examination of mediators and moderators of treatment effects; (b) comparing the Turtle Program to the best available treatment for preschool behavioral inhibition, the Cool Little Kids (CLK) parent psychoeducation group; (c) examining heart rate reactivity and regulation as both baseline moderators of treatment response and as outcome measures; (d) examining parent anxiety disorders as a moderator of treatment response; (e) including a mid-treatment assessment and extending follow-up to one year.


Eligibility Criteria:
Inclusion Criteria:

* child must be attending preschool; child must score within top 15% on parent-rated Behavioral Inhibition Questionnaire

Exclusion Criteria:

* child has a diagnosis of pervasive developmental disorder, selective mutism, or mental retardation; child scores above clinical cutoff on Social Communication Questionnaire; child is currently receiving treatment for anxiety; child does not have a custodial parent who has also consented to participate
Is Detoxification Needed in Medication-overuse Headache?

Medication-overuse headache (MOH) is a disabling condition, yet treatable. According to European guidelines and based on evidence, multidisciplinary detoxification is the first choice of treatment for MOH. However, consensus about the details in such detoxification programs is lacking. Contrary, other headache specialists believe more in treating chronic headache with medication overuse with single-therapy of prophylaxis and no withdrawal of acute medication, based on randomized controlled double-blinded placebo trial with prophylaxes. Only a single RCT has compared single-therapy with prophylaxis to detoxification. However there was no significant difference.

AIM:

1. To compare three different treatment protocols in order to improve the therapy of MOH.
2. To test several baseline variables for being potential predictors for good treatment outcome.
3. To examine the role of epigenetics in MOH.


Eligibility Criteria:
Patients with medication-overuse headache:

Inclusion Criteria:

* Confirmed MOH diagnosis according to the ICHD-III beta (1).
* Eligible for outpatient treatment based on type of medication overuse (without massive pure opioids and barbiturates overuse), and personal resources and motivation.
* Capable of completing headache diary/calendar.
* Age ≥ 18 years old and capable of providing informed consent.
* Medication-overuse headache based on initial tension-type headache (TTH) or migraine.
* Signed informed consent.

Exclusion Criteria:

* Severe physical illness or psychiatric disorders.
* Addiction to alcohol or other drugs.
* Current treatment with headache prophylaxis. Patients can be included minimum 5 weeks after stop of prophylaxis.
* Pregnancy, breastfeeding or planned pregnancy within the next 12 months.
* Inability to provide reliable information about medical history.

Criteria for Control group 1 - Episodic migraineurs:

* Episodic migraine, with/without concomitant tension-type headache, according to the ICHD-III beta.
* Headache days / month ≤ 6 at time of inclusion.
* Days with analgesics / month ≤ 6 at time of inclusion.
* Prophylactics are allowed.
* Age ≥ 18 years old.
* Ability to fill out headache calendar.
* No previous medication overuse.
* No significant co-morbid pain, physical or psychiatric disorders.
* No addiction to alcohol or drug-abuse.
* No pregnancy, breastfeeding or planned pregnancy within the next 12 months.

Criteria for Control group 2 - Healthy volunteers:

•≥ 2 days with headache in the past month at time of inclusion.

* Days with analgesics / month ≤ 6 at time of inclusion.
* Age ≥ 18 years old.
* No significant co-morbid pain, physical or psychiatric disorders.
* No addiction to alcohol or drug-abuse.
* No pregnancy, breastfeeding or planned pregnancy within the next 12 months.
A Mindful Self-compassion Based Intervention for Specialist Rehabilitation Providers

The goal of this clinical trial is to explore the impact of an online compassion-based intervention on burnout among specialist rehabilitation providers. Post-intervention interviews aim to gather information on: burnout and compassion, experiences with the intervention, barriers and facilitators to taking part, and suggestions for improving online course delivery.

Burnout threatens the sustainability of compassionate care in rehabilitation. This project explores the impact of an online compassion-based intervention on burnout among specialist inpatient rehabilitation healthcare providers. Thirty specialist rehabilitation healthcare providers will be recruited to take part. The online intervention will include six weekly live one-hour sessions. Healthcare provider socio-demographic, practice, and wellness measures will be collected at baseline, post-course, and three months later. Qualitative interviews will be used to explore participant views on burnout and compassion, experiences with the intervention, barriers and facilitators to taking part, and suggestions for improving online course delivery. Up to two instructors and support persons will be invited to participate in qualitative interviews to explore their views for improving online course delivery.

Eligibility Criteria:
Inclusion Criteria:

* Employed substantively as a regulated health professional (e.g., physiatrist, nurse, allied health professional) by a specialist rehabilitation institute (e.g., Sunnybrook/St. John's Rehab, University Hospital Network, Providence Healthcare, Westpark Healthcare)
* Over 18 years of age
* Able to speak, read, and write in English
* Willing to take part in the MSC course for up to the full 6-week duration
* Willing to complete all study related questionnaires

Exclusion Criteria:

* Those already having completed a MSC (mindfulness-based stress reduction) course or mindfulness-based cognitive therapy within the past 12 months
* Those employed as agency staff
Food Intake and Appetite in the Children of Mothers With Diabetes

This protocol is for study of the effect of inhibition of parasympathetic outflow on insulin secretion and glucose metabolism. Insulin secretion will be measured during infusions of escalating doses of atropine. Other clinical parameters of parasympathetic inhibition by atropine will also be assessed.

Children of mothers who had diabetes during pregnancy are at an increased risk of diabetes and obesity in later life, effects partly mediated by the early environment experienced by the offspring of diabetic mothers in utero. In this protocol, we address why intra-uterine exposure to maternal diabetes might lead to later childhood obesity. Previous studies of children of diabetic mothers have not detected any alteration in energy expenditure, either as resting metabolic rate or physical activity. We will now examine whether they are at an increased risk of obesity due to differences in food intake. We will assess composition of the diet, patterns of eating, taste preference and physiological responses to a mixed meal. No previous work in human subjects has addressed these issues.

Eligibility Criteria:
* INCLUSION CRITERIA:

Group 1: Offspring of mothers with diabetes during pregnancy.

Maternal diagnosis of type 2 diabetes (by WHO criteria after a 75g OGTT or on clinical grounds with at least one random plasma glucose greater than 200mg/dl) before or during the index pregnancy.

Group 2: Offspring of mothers with diabetes diagnosed following pregnancy.

Maternal diagnosis of type 2 diabetes (by WHO criteria after a 75g OGTT or on clinical grounds with at least one random plasma glucose greater than 200 mg/dl) after the index pregnancy.

It is important to also ensure that these mothers did not have any major disturbance in glucose tolerance during the index pregnancy and a record of normal glucose tolerance after the index pregnancy; therefore they will only be included if there are also:

Adequate records of glucose testing during the index pregnancy and these records are not in keeping with a diagnosis of gestational diabetes (by either WHO criteria if a 75g oral glucose tolerance test has been carried out).

At least one non-diabetic OGTT after the index pregnancy.

EXCLUSION CRITERIA:

1. History of weight loss for child (greater than 2kg over last 6 months).
2. Presence of other major illnesses which might interfere with appetite or food intake in mother or child.
3. Child not living with mother.