cyrilzakka/clinical-trials huggingface dataset:
Surviving Opioid Overdose With Naloxone Education and Resuscitation Trial (SOONER)

Among people at risk of opioid overdose and receiving care in an academic emergency department, family practice, opioid substitution clinic or general inpatient units, does brief opioid overdose resuscitation training and naloxone distribution reduce resuscitation failures in a simulated overdose even, in comparison with standard-of-care referral to a local OEND program, within 14 days post-intervention? Can an integrated participant recruitment and retention strategy recruit approximately 28 eligible participants within 4 weeks and maintain less than 50% attrition rates in the context of a randomized trial on point-of-care OEND and simulated overdose resuscitation performance in family practice, emergency department, and addictions settings?


Eligibility Criteria:
Inclusion Criteria:

1. adults ≥16 years of age, and
2. Eligible for overdose education according to criteria adapted from the 2015 American Heart Association Guidelines by meeting any one or more of the following criteria:

   1. has a history of taking opioids at recognized 'high doses' (whether by prescription or otherwise, defined as \>100mg morphine equivalent per day);
   2. has required emergency care for opioid overdose previously;
   3. is enrolled in opioid agonist treatment programs, including methadone or buprenorphine maintenance programs, or stopped an opioid agonist treatment program in the last 6 months;
   4. uses non-medical opioids, injects opioids, or acquires opioids from sources other than a pharmacy or healthcare setting;
   5. has a history of non-medical opioid use who are being released from prison;
   6. is receiving prescription opioid therapy with risk factors for adverse effects, including i. relevant comorbidities, ii. co-prescriptions of benzodiazepines or other sedatives, iii. concomitant ongoing alcohol use, iv. use of prescription opioids not as prescribed.
   7. is likely to witness an opioid overdose, defined as anyone who lives with or is in frequent contact with others who use opioids, or who has previously witnessed an opioid overdose.

Exclusion Criteria:

1. plan to move away from Toronto during the study period
2. have no mode of contact or follow-up,
3. have a community do not resuscitate order,
4. have a terminal illness, end-of-life care, or illness likely to result in death within the study period,
5. are an active or previously practicing healthcare professional or professional first responder (e.g.: firefighter, police officer, lifeguard, industrial first responder), or
6. have insufficient English language skills to participate in the study.
Fish Oil-derived Omega-3 Fatty Acids on Gut Microbiota and Lipid Metabolome in Type 2 Diabetes Mellitus

The objective of this research was to investigate the impact of Omega-3 PUFAs on the gut microbiota and serum lipid metabolites in participants diagnosed with type 2 diabetes, employing high-throughput sequencing technology and untargeted lipidomics.

The pathogenesis of diabetes is associated with perturbations in lipid metabolism and intestinal flora. Nevertheless, the precise impact of Omega-3 polyunsaturated fatty acids (Omega-3 PUFAs) on key lipid metabolites, intestinal microorganisms, and fungi linked to type 2 diabetes remains indeterminate. The objective of this research was to investigate the impact of Omega-3 PUFAs on the gut microbiota and serum lipid metabolites in participants diagnosed with type 2 diabetes, employing high-throughput sequencing technology and untargeted lipidomics. The investigators randomly allocated 110 eligible participants into either the fish oil intervention group or the placebo control group for a 3-month double-blind randomized intervention trial. Bacterial 16S rDNA, fungal diversity analysis of Internally Transcribed Spacer sequences (ITS) and untargeted lipidomics were used to investigate the effects of Omega-3 PUFAs on intestinal microbiota and serum lipid metabolites.

Eligibility Criteria:
Inclusion Criteria:

* Patients with type 2 diabetes have been diagnosed;
* Male or female aged 18-70 years;
* After listening to the project presentation, voluntarily participate in the study and sign an informed consent form.

Exclusion Criteria:

* Pregnant or lactating women;
* Poorly controlled diabetes, i.e. HbA1c\>9%；
* Have taken omega-3 PUFAs-related supplements in the past six months；
* Taking lipid-lowering drugs or other drugs that affect blood lipid metabolism；
* Patients with severe diabetic complications, severe hypertension, combined with
* diseases of the heart, brain, liver, kidney, thyroid and hematopoietic system, psychosis；
* Patients with severe immune system disorders；
* Have special diets: vegetarians, weight managers, ketogenic test takers, etc；
* The attending physician deems the participant unsuitable
Fuel Selection During Eccentric Cycling With Glucose Ingestion

This study compares fuel selection during eccentric and concentric cycling, with (placebo) or without glucose ingestion during exercise. After a 2-week familiarization and habituation with the ergometers, subjects will complete four experimental conditions in a randomized order: concentric with placebo, eccentric with placebo, concentric with glucose, eccentric with glucose.

Cycling on a cycle ergometer typically requires repeated concentric muscle contractions to push on the pedals and produce mechanical work. An eccentric cycling ergometer has a motor that rotates the cranks with a predetermined torque, the cyclist needs to resist to the movement of the cranks. This leads to eccentric muscle contractions, the work is thus produced while the muscle is lengthening (negative work). This mode of exercise is known to produce a lower oxygen consumption (energy cost) for the same mechanical power output and also leads to muscle damage which can interfere with fuel selection.

Eligibility Criteria:
Inclusion Criteria:

* Low alcohol consumption (\<3 drinks/week)
* Non-smokers
* Not regularly taking medication for a known pathology
* Regularly practices endurance sports (cycling, running, etc.)

Exclusion Criteria:

* Intolerant to glucose (according to WHO standards)
* Musculoskeletal injury or illness affecting exercise performance
* Failure to respect protocol guidelines (diet, exercise prior to experimentation, etc.)
Immediate Axillary Plasty With a Pedicled Muscle Flap for Breast Cancer Related Lymphedema Prevention

The purpose of this comparable cohort study is to evaluate the efficacy and safety of immediate axillary plasty with pedicled partial Latissimus Dorsi muscle flap for lymphedema prevention in breast cancer patients who are undergoing axillary dissection.

Upper limb lymphedema is the main complication of axillary dissection. It is estimated that as many as 50% of patients undergoing lymph node dissection go on to develop lymphedema, with significantly decreased quality of life with frequent infections, decreased range of motion, and a cosmetic deformity. The treatment of lymphedema was be frustrated by technical difficulties and gave rise to a heavy budget burden. Some retrospective studies revealed that immediate and delayed breast reconstruction with lattismus dorsi flap brought unexpected relief to the upper limb lymphedema. The current study was composed to assess whether transferring a pedicled partial latissimus dorsi muscle flap to the axilla would prevent the occurrence of post-mastectomy lymphedema.

This prospectively designed cohort study have two parallel arms. Patients undergoing axillary dissection would be recruited to one of the two groups, according their own preference.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing axillary lymph node dissection

Exclusion Criteria:

* Prior iplateral upper limb edema
* Plan for breast or axillary reconstruction
* The thoracodorsal vessel damage
* Muscle flap volume too low
Comparative Effectiveness of AKYNZEO® and Standard of Care (Including EMEND®) for the Prevention of Nausea and Vomiting (CINV) in Cancer Patients

This pragmatic trial addresses the clinical gap through the generation of evidence on the comparative effectiveness between AKYNZEO® and Standard of Care (SoC, including EMEND®) in the real-life setting


Eligibility Criteria:
Inclusion Criteria:

* Male or female, Age ≥ 18 years
* Have a histological or cytological confirmed solid tumor malignancy
* Patient scheduled to receive their first course of anthracycline cyclophosphamide (AC) based chemotherapy regimen or Moderately Emetogenic Chemotherapy for the treatment of solid malignant tumor
* Patient scheduled to receive CINV prevention with AKYNZEO® or Standard of Care according to the summary of product characteristics based on the judgement of their investigator's
* Naïve of CT
* ECOG performance up to 2
* Able to read, understand and follow the study procedures
* Patient with Health insurance

Exclusion Criteria:

* Pregnancy and breastfeeding women;
* Hypersensitivity to active substances, excipients or other ingredients of Akynzeo® or Emend®;
* Protected patients: majors under guardianship, tutorship or other legal protection, deprived of liberty by judicial or administrative decision
Instrument Applied and Manual Manipulation Induced EMG Response in Asymptomatic Subjects

The purpose of this study is to determine the affects of instrumental and manual manipulation on the EMG response of asymptomatic subjects.


Eligibility Criteria:
Inclusion Criteria:

Asymptomatic subjects (without somatosensory peripheral pain) will be recruited in the study. Subjects must sign an informed consent.

Exclusion Criteria:

Subjects with heart failure and any nervous system diseases will be excluded from the study. Additional exclusions include osteoporosis, diabetes, pregnancy, vascular insufficiency, and history of joint replacement therapy. Subjects under medical treatment, surgery and trauma within six months will be excluded.
Efficacy and Safety Study of QAW039 in the Treatment of Patients With Moderate to Severe Atopic Dermatitis.

The purpose of this study is to determine whether QAW039 is safe and has beneficial effects in people who have moderate to severe atopic dermatitis (AD).


Eligibility Criteria:
Key Inclusion Criteria:

* Presence of atopic dermatitis confirmed by Itchy skin condition in the past 12 months plus three, or more, of the following:

  * History of involvement of the skin creases (fronts of elbows, behind knees, fronts of ankles, around neck or around eyes)
  * Personal history of asthma or hay fever
  * History of generally dry skin in the past year
  * Onset before age of 2 years
  * Visible flexural dermatitis
* Patients with an EASI score of ≥15 at screening and stable AD (not currently experiencing an acute flare of their AD).
* Patients that have been treated with topical corticosteroids or topical calcineurin inhibitors on at least one occasion, or could not use topical drugs (due to contraindications, side effects, etc.) and are candidates for or have previously received systemic treatment.

Key Exclusion Criteria:

* History of hypersensitivity to any of the study drugs (including local anesthesia) or to drugs of similar chemical classes (CRTh2 antagonists)
* History of serious allergic reactions to any allergen, such as anaphylactic shock or life-threatening asthma, prior intubation, respiratory arrest, hospitalization due to asthma within the last 3 months or seizures as a result of asthma
* History of clinically significant ECG abnormalities or screening/baseline ECG that demonstrated clinical significant abnormalities which could affect patient safety or interpretation of study results
* History of long QT syndrome or whose QTc interval (Frederica's) was prolonged (\>450 msec for males and females) at screening
* Use of topical prescription treatment (e.g., topical corticosteroids, calcineurin inhibitors, antibiotics, etc.) within two weeks prior to initial dosing of study drug. Patient use of emollients was encouraged
* Exception: For local atopic dermatitis flares during this 2-week interval, mild topical corticosteroids may be taken short term (up to one week)
* Recent previous systemic treatment with phototherapy, systemic antihistamines, immunosuppressive agents (e.g., cyclosporine, mycophenolate, or oral tacrolimus, including therapeutic proteins)
* Patients on maintenance immunotherapy who either began their allergen specific immunotherapy regimen or had a clinically relevant change to their immunotherapy within one month prior to granting informed consent
* Patients on high-dose statin therapy (\>40 mg fluvastatin or 20 mg simvastatin, atorvastin, pravastatin, or rosuvastatin \[10 mg if Asian\])
* Excessive exposure to UV light in the three weeks prior to study start (screening), including tanning and sun beds and/or planning excessive sunbathing or beach holidays with associated sun bathing during the treatment period
* History of hypertrophic scarring
* Body mass index \<17 or \>40 kg/m2
The Effect of Dual Task Training in Patients With Stroke

The aim of this study was to investigate the effect of dual-task training on gait, balance, and quality of life in individuals with stroke. The study included 30 individuals aged 30-80 years with stroke. All participants were assessed using the 10-meter walk test (10MWT), 10MWT under dual-task interaction (DTI), timed up and go (TUG), 30-Second Chair-Stand Test (30s-CST), Berg Balance Scale (BBS), Short Form 36 (SF-36). Participants were randomized into two groups. Both groups received conventional physiotherapy for approximately 1 hour, five days a week. Group I also received dual-task training.


Eligibility Criteria:
Inclusion Criteria:

* Having a score of 24 or above on the Mini-Mental State Test,
* Being able to walk at least 10 meters without using a walking aid
* Having a total score of 5 on the motor and cognitive sections of the Functional Independence Scale.

Exclusion Criteria:

* Neurological and orthopedic problems that could affect motor performance and balance
* Communication problems
* Patients who had received Botulinum Toxin injection treatment in the last six months
Effect of Vitamin K 2 on Vascular Calcification in Hemodialysis Patients

The aim of this study is to assess the effect of supplementation of vitamin K2 (menaquinone, MK-7) and cholecalciferol (inactive vitamin D) on circulating levels of calcification regulators and to assess their safety in pediatric patients on regular hemodialysis patients.

Vascular calcification occurs in more than half of chronic renal failure patients, which mainly appears in the large and medium size arteries \[3, 4\]. It seems that vas¬cular calcification is caused by dynamic imbal-ance of intravascular calcium and phosphorus. However, more and more studies pointed out that vascular calcification were related with local cell's function and biological characteris¬tics.

The aim of this study is to assess the effect of supplementation of vitamin K2 (menaquinone, MK-7) and cholecalciferol (inactive vitamin D) on circulating levels of calcification regulators and to assess their safety in pediatric patients on regular hemodialysis patients.

Eligibility Criteria:
Inclusion criteria:

* Patients aged 6-18 years
* Patients on hemodialysis since 3 months or longer
* Hemodialysis frequency 3 times or more weekly

Exclusion criteria:

* Patients with life expectancy \< 3 months
* Patients taking warfarin
* Patients with known intestinal malabsorption
Fiber Supplementation After Bariatric Surgery

Test compliance and gastrointestinal tolerance of a 30-day dose of potato starch in bariatric patients, and determine if short chain fatty acids, specifically butyrate, increase in response to the dosages of potato starch.

Despite the successful weight loss associated with bariatric surgery, epidemiology studies have observed conflicting associations between bariatric surgery and incidence of colorectal cancer (CRC), potentially suggesting an increased risk of CRC post-surgery. The investigators have identified a potential mechanism between bariatric surgery and CRC via profiling dietary intake, gut microbiota colonization, and short-chain fatty acid (SCFA) production, including acetate, propionate, and butyrate. They have demonstrated a decrease in SCFA after bariatric surgery. As intestinal SCFAs inhibit colon cancer cell proliferation, these results may suggest a mechanism linking bariatric surgery, SCFA levels, and CRC.

The objective of this protocol is to implement a 30-day fiber supplement, made from potato starch, as previous studies have successfully demonstrated that a resistant starch supplement increases intestinal SCFAs in healthy populations. The resistant starch supplement will be initiated 90-days post-bariatric surgery, which is when fiber supplements are tolerated. Fecal samples will be collected pre- and post-supplement and a targeted liquid chromatography/mass spectrometry platform will quantify levels of SCFAs. As SCFA levels have been associated with reduced hunger in other studies, the investigators will determine if hunger levels are altered in response to the supplement. The proposed study is described in the following aims:

Specific Aim 1. Assess compliance and gastrointestinal tolerance of a 30-day dose of potato starch in bariatric patients.

Specific Aim 2. Determine if short chain fatty acids, specifically butyrate, increase in response to the dosages of potato starch.

Exploratory Aim. Determine if there are changes in dietary intake, appetite, and satiety in response to the dosages of potato starch.

Eligibility Criteria:
Inclusion Criteria:

* Adults ≥ 18 years
* Bariatric surgery at Dartmouth Medical Center
* Daily protein intake ≥ 60 grams
* Daily fluid intake ≥ 48 fl oz.

Exclusion Criteria:

* \> 550 lbs at bariatric surgery date.
* Allergies to potato starches.
* Surgical complications per bariatric team members
* Individuals who cannot speak and/or write in English.
Injection Assistance Device Versus Manual Injections for Delivery of Dermal Fillers

The purpose of this study is to characterize the safety and performance in normal therapeutic use of the Artiste System in comparison to standard manual administration of dermal fillers. Subjects are recruited from the investigator's practice and randomized to receive treatment with the Artiste System on either the left or right nasolabial fold, the contralateral fold to be treated with standard manual injections. Treatments occur in a single session to achieve optimal cosmetic results (OCR) balanced on both sides. Investigators are encouraged to use a variety of types and brands of dermal fillers, recruiting subjects for the study as necessary. Safety and performance evaluations will be made through a combination of clinical observations, questionnaires for the subject and for the Treating Investigator, and spontaneous reports of adverse events. There are 6 required study visits: Screening, Day 1 (Treatment Day), Day 3, Day 8, Day 15, and Day 29.

This is a randomized, evaluator-blind, bilateral, controlled, multicenter study. Subjects are to be recruited from the investigator's practice and randomized to receive treatment with the Artiste System on either the left or right nasolabial fold, the contralateral fold to be treated with standard manual injections. Treatments will occur in a single session to achieve optimal cosmetic results (OCR) balanced on both sides. There are no specific requirements with respect to the type or brand of dermal filler to be used, but the investigators will be encouraged to use a variety of types and brands in the context of the study, recruiting subjects for the study as necessary. Safety and performance evaluations will be made through a combination of clinical observations (by a Blinded Evaluator distinct from the Treating Investigator), questionnaires for the subject and for the Treating Investigator, and spontaneous reports of adverse events. There will be a total of 6 required study visits: Screening, Day 1 (Treatment Day), Day 3, Day 8, Day 15, and Day 29.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, at least 18 years of age;
* Presenting at Screening with bilateral nasolabial folds rated 2 or greater on the Wrinkle Severity Rating Scale (SRS) by the Blinded Evaluator.
* Willing and able to provide informed consent;
* In good health, based upon the subject's report and medical history.

Exclusion Criteria:

* History of keloids, bleeding disorders, or severe allergic or anaphylactic reactions, including hypersensitivity to any components of the study materials;
* Active inflammatory process, scarring, or dense facial hair in the area of the nasolabial folds;
* Any chronic or acute medical condition that, in the opinion of the investigator, may interfere with evaluation of the study results or place the subject at undue risk;
* History of previous cosmetic treatment of the nasolabial folds within 6 months prior to the Screening visit;
* Planning to undergo facial surgery during the 4-week course of the study;
* Participation in a clinical investigation within the 30 days prior to the Screening visit.
Investigation of Road-crossing Safety Before and After Training Between Parkinson Disease Pedestrians and Older Pedestrians

As society ages, a large amount of human factors related research has been carried out into the subject of the safety of the elderly in their daily lives. However, most research focuses on the general elderly population and there is a serious lack of research into elderly sufferers of Parkinson's disease (PD), who receive a substantial amount of attention in medical circles. In the investigators previous study, the investigators have found that patient with PD had decreased ability to cross the road as compared to age/gender matched control subjects. Hence, this research proposed several training programs to enhance the safety of crossing road, including safe place finding，roadside search，time gap and perception of other's intentions. The investigators will compare the parameters of crossing road ability before and after training programs in patients with PD and control subjects.

The results of this research will clarify the correlation between medical scale test indicators and movement safety for patients with PD. The effects of training programs will be provided for further safety management and design concepts to improve the lives of this disease group.


Eligibility Criteria:
Inclusion Criteria:

* Patients with Parkinson's disease
* Age between 18-80 years
* Patients signed the consent form

Exclusion Criteria:

* Patients with atypical parkinsonism