cyrilzakka/clinical-trials huggingface dataset:
Clinical Evaluation of a Specific Enteral Diet for Diabetics

The hypothesis of the proposed trials is that the regular intake of a specific diet designed for enteral nutrition of type 2 diabetic patients results into a better nutritional status. Thus, the aim of the study is to scientifically evaluate the healthy effects of the administration of an enteral complete diet for diabetic patients (T-Diet plus Diabet).

This new complete diet has been carefully formulated, and incorporates functional ingredients based on:

1. A good gastrointestinal and metabolic tolerance of the product.
2. Beneficial outcomes in the nutritional status.
3. A good control of the glycaemic response and the lipidic profile, allowing an improvement of metabolic syndrome and insulin resistance indicators and hunger-satiety regulation.

The experimental enteral product is a complete diet that includes, as carbohydrates, high-molecular maltodextrin, resistant maltodextrin, fructooligosaccharides and cellulose, and does not contain added fructose. Indeed, this product contains eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA).

Eligibility Criteria:
Inclusion Criteria:

* Diabetic Subjects older than 55 years.
* Male or female
* Requirement of total enteral nutrition (TEN) during at least 3 months.
* Under medical supervision.
* Voluntary informed consent for participation.

Exclusion Criteria:

* Unstable clinical situation
* Fatal illness
* Patients treated with lipidic drugs
* Refusal to participate in the study or being enrolled in other clinical trials.
* Social or humanitarian reason
Assessment of the Safety and Performance of Ankle Ligament Supports in the Context of a Return to Sport After Sprain

Decathlon has developed Ankle STRONG products which are medical devices that must be positioned around the ankle to limit ankle sprain occurrence.

The Ankle STRONG devices cover a range of 3 products (Ankle STRONG 100/500/900). The differences between the devices is based on the strength of compression and the ankle maintain.

The objective of this multicentre study is to collect data on the related clinical complications and clinical outcomes of market-approved Decathlon Ankle STRONG products to demonstrate safety and performance of these devices in a real-world setting.


Eligibility Criteria:
Inclusion Criteria:

* Subject is aged ≥ 18 years old
* Subject has a recent mild OR moderate OR serious ankle sprain
* The current condition of his/her ankle allows the subject to resume usual physical activity
* Subject has been informed and is willing to sign an informed consent form
* Subject is willing to comply with protocol requirements and return to the study center for all clinical evaluations and required follow-up (12 weeks)
* Subject is affiliated to the French social security regime

Non-inclusion Criteria:

* Subject has conditions that may interfere with his/her ability to understand protocol requirements, participate in scheduled visits, or provide his/her informed consent
* Subject has worn a support (ankle brace or articulated orthosis) since his/her recent injury
* Subject has resumed regular physical activity since his/her recent injury
* Subject has any medical condition that could impact the study at investigator's discretion
* Subject has a known hypersensitivity or allergy to the components of the device (polyamide, elastane, polyester, cotton)
* Adult subject to legal protection measure
Smartphones Aggravating Anxiety Symptoms

The goal of this study is to assess if excessive use of smartphone apps of social media can impact a person's mental health. The study is aimed at improving the usage of smartphones which might help improve the mental health of patients. The goal is not to discourage the use of smartphones but instead to utilize smartphones in a way that they do not impact lives.


Eligibility Criteria:
Inclusion Criteria:

* For patients aged 18 years or older experiencing mild symptoms of anxiety or depression and who have a GAD-7 score 5 and above.
* Patient should have smart phone and should be using Facebook, Instagram, Twitter, Tik Tok, and Pinterest social media apps.
* Patients should have email access.

Exclusion Criteria:

* Any patient who uses a smartphone for tracking glucose for diabetes management, heart rate, or any chronic illness which is being managed through a smartphone app.
* Any patient who uses more than one personal smartphone
* Any patient who is a suicide risk as per PHQ-9 score, current recreational drug usage, or alcohol abuse.
* Any patient who has suicidal ideation as per PHQ-9 assessment before or during the study period will be excluded, (all patients will be monitored for suicidal ideation by PHQ-9 scoring method at day 1, week 6, and week 12, but it is the responsibility of the patient to inform the study team if they have developed any suicidal ideation throughout the study period).
* Patients with activated POA (Power of Attorney - Healthcare), diagnosis of mental retardation or current disability due to any psychiatric disorder or severe depression with a high risk of suicide should be excluded.
* Any patient currently undergoing ECT (electroconvulsive therapy) for severe depression.
* Any patient taking prescribed SSRIs/SNRIs, with a change and not taking them continuously in last 30 days (not a new diagnosis of anxiety). If change they will be excluded.
Gynaecological Gender-affirming Surgeries

The goal of this prospective cohort study is to learn about the patient report outcomes after gynaecological gender-affirming surgeries (i.e. hysterectomy, tubectomy, colpectomy) among trans-masculine and non-binary individuals (assigned female at birth).

The main question it aims to answer are:

• What is the experienced effect of gynaecological gender-affirming surgeries

Participants will be asked to fill out a questionaire pre-operatively and 3,9 and 18 months post-operatively.


Eligibility Criteria:
Inclusion Criteria:

* assigned female at birth
* scheduled to undergo gynaecological gender-affirming surgery (i.e. hysterectomy, ovariectomy, tubectomy and/or colpectomy)

Exclusion Criteria:

* age below 18 y/o
* surgery combined with other surgeries (e.g. urethroplasty, metoidioplasty)
New Diabetes Mellitus and Pre-Diabetes With First-time Diagnosed Coronary Artery Disease

A prospective analytic study to evaluate the incidence, clinical and laboratory characteristics, extent of coronary artery disease and short-term outcome of newly diagnosed diabetes and pre-diabetes in patients with first-time diagnosed coronary artery disease treated in Saud Al Babtain Cardiac Center.


Eligibility Criteria:
Inclusion Criteria:

* First time diagnosed coronary artery disease as confirmed by invasive coronary angiography
* Emergently or electively admitted as coronary artery disease patients.
* Informed consent form

Exclusion Criteria:

* Prior diagnosis of diabetes or pre-diabetes based on the diagnostic criteria of the American Diabetes Association (ADA, 2020)
* Known coronary artery disease
Virtual Assistant for COVID-19 PPE

The COVID virus is acquired through droplet and micro droplet transmission. Although healthcare workers must adhere to strict up-to-date clinical procedures to minimize exposure to the virus and avoid contamination, the assumption that everyone can precisely remember every step is improbable as many of these procedures are quite complex and involve multiple steps in stressful situations. Further the use of a trained safety officer to ensure adherence is not always feasible due to the ever growing demand of healthcare providers. Investigators propose to utilize the Amazon Alexa device and Alexa Skills application to develop a voice enabled virtual assistant to guide healthcare professionals through the exact steps of clinical procedures including the donning and doffing of PPE, intubation and extubation procedures.

Methods A total of 10 staff anesthesiologists will be recruited to participate in phase 1 of the study to evaluate the utility and functionality of this VA device.

A total of 40 healthcare professionals will be recruited to participate in phase 2 of the study. Anesthesia providers (staff and fellows), anesthesia assistants, respiratory assistants and operating room nurses will be randomized to receive instructional guidance by the VA on one test occasion and a human coach on another occasion. During this phase of the study, the effectiveness of this VA prototype will be compared with a trained human safety officer / coach in its ability to provide instructional guidance for 4 safety and clinical procedures: 1) proper donning of personal protective equipment (PPE); 2) doffing of PPE; 3) intubation (putting in a breathing tube) and 4) extubation (taking out a breathing tube).


Eligibility Criteria:
Inclusion Criteria:

* Only anesthesia attending staff are allowed in the phase 1 study.
* Any working anesthesia staff and fellow, anesthesia assistant, respiratory assistant and operating room nurse are qualified to take part in phase 2 of this study. However, only anesthesia staff and fellows and anesthesia assistants will participate in the part that involves intubation and extubation.

Exclusion Criteria:

• Unwillingness to enter the study for phase 1 or phase 2.
The Effect of Mandala Painting on Anxiety in Coronary Heart Patients

This study was planned as a randomized controlled trial to determine the effect of mandala painting on the anxiety of coronary heart patients.

Patients in the control group will receive routine care.Patiens in the experimental group will receive routine care and mandala painting. Experimental group will paint mandala for 30 minutes/day in the evenings for six consecutive days. In order not to interrupt the duties of the nurse and doctor in the clinic, it was planned for the experimental group to paint mandalas in the evening. Six pre-selected mandalas were planned to be printed separately on A4 paper. Each patient will be given a new mandala each day. At the beginning of the study, six colors will be given to the experimental group (yellow, blue, green, red, purple, brown). It was planned to do it for 6 days, as it was found that painting mandala for more than a week in the studies could reduce the patient's attention. In addition, based on the average hospitalization days of the patients, reaching patients for more than a week will be a problem.

Eligibility Criteria:
Inclusion Criteria:

* Having agreed to participate in the research/approved the informed consent form
* No visual or hearing impairment
* Hospitalization due to Coronary Heart Disease (patients hospitalized with the diagnosis of acute coronary syndromes such as stable angina, unstable angina, myocardial infarction, percutaneous coronary intervention and stent implantation),
* Being over 18 years old,
* Being at least literate
* The absence of any problem that would prevent him/her from painting mandala (no problem in his arm or hand that would prevent his movement (such as paralysis, or the presence of a catheter on the hand), no serious illness)
* Must not have a diagnosis of mental illness/anxiety disorder

Exclusion Criteria:

* Control group patients who coincided with the same room as the intervention group, by randomization.
* Patients who want to quit the study voluntarily during the study
* Patients whose general condition deteriorates (such as altered hemodynamics or consciousness)
Hirschsprung's Disease: Surgical Techniques and Quality of Life

This is an observational study examining the long-term quality of life in patients with Hirschsprung's Disease in relation to the choice of surgical technique.

Hirschsprung's Disease (HD) is a developmental defect causing functional obstruction of bowel. It is a condition that almost always requires surgical intervention. This study aims to examine the relation between quality of life and surgical technique in patients with Hirschsprung's disease in hopes of providing insight into advantages and disadvantages of different surgical techniques employed at OUH, department for general surgery in the time between 1985 and 2012. This will be done based on answers given on a set of validated questionnaires that has been sent to all patients diagnosed with HD in the years 1985 to 2012 at OUH, department for general surgery.

Eligibility Criteria:
Inclusion Criteria:

* All patients diagnosed with HD at the Surgical Department at Odense University Hospital from 1985 to 2012 will be invited to enroll in the study.

Exclusion Criteria:

* lack of informed consent, pregnancy, wrong diagnosis and inability to understand or answer the questionnaires.
Entertainment Media to Deliver Educational Messages About Mammography in Saudi Arabia

This clinical trial aims to test if Elissa's Entertainment-Education (EE) song can influence Saudi females' intention to perform breast cancer early screening via mammogram.

This study will be guided by a scarcely applied theoretical model that integrates the issue involvement concept into the Theory of Planned Behavior (TPB) to test the role of issue involvement in predicting intention to perform breast cancer early screening via mammogram among Saudi females after exposure to EE message.

Eligibility Criteria:
Inclusion Criteria:

* Saudi Arabian
* female

Exclusion Criteria:

* Females 39 or younger
* females above age 69 years
* females who have had breast cancer
* females that have had risk-reducing bilateral mastectomies
Acupuncture Treatment for Schizophrenia-related Central Obesity

This clinical trial aims to test the effect of acupuncture in patients with schizophrenia-related central obesity. The main question it aims to answer is:

• The effect, safety, and maintenance of acupuncture on schizophrenia-related central obesity.

Participants will receive acupuncture treatment on purpose acupoints, acupuncture on acupoint peripheries, or fake acupuncture treatment on purpose acupoints for 20 weeks. And they need three follow-up visits during the treatment period and two follow-up visits after treatment.

Researchers will compare the waist circumstance of these three groups to see if the purpose acupoints are valid for schizophrenia-related central obesity.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis with schizophrenia (Diagnostic and Statistical Manual of Mental Disorders: Fifth Edition);
* Continuous use of antipsychotics for more than one year (may be combined with mood stabilizers, antianxiety medications, antidepressants, and benzodiazepines);
* Abdominal obesity (central obesity): waist circumference ≥90cm for men or ≥85cm for women (Chinese Standard);
* All participants and their guardians signed informed consent.

Exclusion Criteria:

* Had various traditional Chinese medicine or chemical drugs, or acupuncture treatments for central obesity within two weeks before enrollment;
* Pregnant or lactating woman;
* Organic mental disorders and mental disorders induced by psychoactive and non-addictive substances;
* With other diseases affecting their mental state (e.g., chronic obstructive pulmonary disease, coronary heart disease, angina pectoris, stroke, painful joint diseases, severe psychiatric diseases, tumors, and other physical diseases)
* Severe liver and kidney insufficiency or other serious diseases of the system;
* With a family history of metabolic diseases such as hypertension, diabetes, and hyperlipidemia;
* Acupuncture dizziness, needle phobia, and other intolerant acupuncture treatment;
* Patients who are not treated according to the regulations, cannot determine the efficacy or have incomplete data affecting the efficacy and safety evaluation.
Comparison of Repaglinide and Gliclazide in Chinese Subjects With Type 2 Diabetes Never Received Oral Antidiabetic Drug Treatment

This trial is conducted in Asia. The aim of this clinical trial is to investigate the blood glucose lowering effect and the safety profile of repaglinide given alone compared to gliclazide given alone in Chinese subjects with type 2 diabetes who never have been treated with oral anti-diabetic drugs (OADs). This study also investigates the augment effect of repaglinide on the phases of insulin secretion as a subgroup study.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes
* Oral anti-diabetic drug (OAD) naïve (unsystematic OAD treatment 6 months prior to this trial is allowed)
* Insulin naïve (less than 1 week of daily use of insulin therapy before trial start is allowed)
* Lipid-lowing agent naïve
* HbA1c: 6.5-8.5%
* Fasting glucose: 6.1-13.0 mmol/L (110-234 mg/dl)
* Body Mass Index (BMI): 20-35 kg/m\^2
* Be able and willing to perform self-monitored plasma glucose (SMPG)
* Be able and willing to eat 3 main meals per day
* Only applicable to subjects who will participate in the subgroup study: Be able and willing to perform and complete IVGTT (intravenous glucose tolerance test) at additional visits

Exclusion Criteria:

* Known or suspected allergy to repaglinide, gliclazide, or related products (for example sulfonamide or other sulphonylureas (SUs)), or any of the excipients in the study drugs
* Previous participation in this study
* Participation in a study of another investigational drug within 1 month prior to study start
Comparison of Gait in Different Support Conditions for Foot Drop

Foot drop is a complication accompanying a variety of conditions and refers to difficulty in lifting the foot upwards about the ankle. Foot drop is a common outcome of conditions including cerebral palsy, brain/spinal cord injury, muscular dystrophy, stroke and after chemotherapy. Foot drop can lead to trips and falls for the individual if the foot catches on the ground when walking, negatively impacting on independence and quality of life.

Approximately 46,720 children and adolescents in the UK have the above conditions and current treatment for individuals with foot drop include use of a lycra sock for those requiring low support and a rigid Ankle Foot Orthosis (AFO) for those requiring high support. The current problem is that all children and adolescents requiring more than low support of the lycra sock are fitted with an AFO, which can lead to muscles becoming weak over time as the AFO restricts almost all movement about the ankle.

This study will assess the use of a new device, the OrthoPed splint, in young people aged 4 - 17 years old who have moderate foot drop. The OrthoPed splint has been developed to be used as a long-term device and aims to reduce loss of strength by allowing more ankle function than an AFO.

This study aims to assess the feasibility of recruiting children and adolescents with foot drop into a study, collecting information on their movement and how well they walk when wearing different support devices for foot drop. Each person in the study will be measured when walking barefoot (no external support) and when wearing an AFO, Lycra sock and the OrthoPed splint. This feasibility study will inform the design, management, and delivery of a future larger randomised, controlled, non-inferiority trial.


Eligibility Criteria:
Inclusion Criteria:

* Age 4 - 17 years old
* Diagnosed moderate unilateral or bilateral foot drop
* Able to walk independently
* Minimum of 5 degrees of ankle dorsiflexion with or without gravity (Oxford Scale 2-4, Clarkson (2010))

Exclusion Criteria:

* Younger than 4 or older than 17 years old
* Severe foot drop that requires higher levels of support than elastic splint
* Unable to walk independently
* Visual impairment when corrected to not be able to see targets when walking
* Unable to understand and or cooperate with study protocol
* Health contraindications to exercise e.g. cardiac disease
The Effect of Mild Traumatic Brain Injury on Recovery From Injury

Mild traumatic brain injury (TBI) is a common injury that can produce significant functional sequelae and ongoing disabling symptoms. Predicting who will have an uncomplicated recovery and who will suffer ongoing symptoms is difficult. This protocol evaluates the use of neuropsychologic testing after mild TBI in injured patients to attempt to objectively establish predictors of long term disability and functional recovery.

Patients who are hospitalized and who have suffered mild TBI (loss of consciousness or post-traumatic amnesia; Glasgow Coma Score 13-15; admitted within 24 hours of injury; able to read, speak, and understand English) who do not have pre-injury dementia or significant cognitive impairment will undergo computerized neuropsychologic testing using a previously validated tool that has been effective in sports-related mild TBI. Sequential testing will be performed during recovery and patients who report disabling symptoms and/or functional impairment will be compared to patients who recover uneventfully. Goal is to identify those parameters that predict early who may suffer long term sequelae or functional impairment and therefore benefit from early cognitive rehabilitation. Secondary goals are to establish objective parameters for functional recovery after mild TBI.

Eligibility Criteria:
Inclusion Criteria:

* Mild TBI
* Admitted within 24 hours of injury
* Able to read, speak,and understand English

Exclusion Criteria:

* Expected to die of their injuries
* Pre-existing dementia or significant cognitive impairment
* Neurologically impaired and incapable of completing testing
* Physically incapable of using arms/hands to complete computerized testing
Pharmacokinetics of Understudied Drugs Administered to Children Per Standard of Care

Understudied drugs will be administered to children per standard of care as prescribed by their treating caregiver and only biological sample collection during the time of drug administration will be involved. A total of approximately 7000 children aged \<21 years who are receiving these drugs for standard of care will be enrolled and will be followed for up a maximum of 90 days. The goal of this study is to characterize the pharmacokinetics of understudied drugs for which specific dosing recommendations and safety data are lacking. The prescribing of drugs to children will not be part of this protocol. Taking advantage of procedures done as part of routine medical care (i.e. blood draws) this study will serve as a tool to better understand drug exposure in children receiving these drugs per standard of care. The data collected through this initiative will also provide valuable pharmacokinetic and dosing information of drugs in different pediatric age groups as well as special pediatric populations (i.e. obese).

The purpose of this study is to characterize the PK ( Pharmacokinetics) of understudied drugs administered to children per standard of care as prescribed by their treating caregiver. This will be accomplished by the collection of biological samples during the time of drug administration per standard of care as prescribed by the caregiver. The prescribing of drugs to children will not be part of this protocol.

Aim #1: Evaluate the PK of understudied drugs currently being administered to children.

Hypothesis #1: The PK of understudied drugs in children will differ from adults and within children according to pediatric age groups or special population.

Aim #2: Explore the pharmacodynamics (PD) of understudied drugs currently being administered to children.

Hypothesis #2: The PD of targeted drugs in children will differ from adults.

Aim #3: Evaluate the influence of genetic factors, metabolic and protein profiles on therapeutic exposure.

Hypothesis #3: Genetic polymorphisms in drug metabolizing enzymes and metabolic and proteomic profiles will impact drug exposure in children.

Eligibility Criteria:
Inclusion Criteria:

* 1) Children (\< 21 years of age) who are receiving understudied drugs of interest per standard of care as prescribed by their treating caregiver

Exclusion Criteria:

* 1) Failure to obtain consent/assent (as indicated)
* 2) Known pregnancy as determined via interview or testing if available.