cyrilzakka/clinical-trials huggingface dataset:
Effects of Plant-based Polar Lipids on Acute and Second Meal Glucose Tolerance and Appetite Sensations

The overall goal of the project is to increase knowledge which can be used for the development of food products with anti-diabetic properties, with the purpose to facilitate healthier food choices for people. More specifically the primary purpose is to evaluate effects on cardiometabolic test markers of bioactive compounds in healthy humans. Previously the investigators reported beneficial effects of oat polar lipids on cardiometabolic risk markers. In this study the effects previously observed will be compared with cardiometabolic effects of another plant based lipid.


Eligibility Criteria:
Inclusion Criteria:

* Apparently healthy men and women
* non-smokers
* between 20-40 years of age
* BMI between 18,5-30 kg/m2
* No known metabolic disorders or food allergies.
* The test subjects should follow a normal diet in accordance with the Nordic Nutrition Recommendations.

Exclusion Criteria:

* Fasting blood glucose ≥6.1 mmol/L
* Use of antibiotics or probiotics in the last three months or during the study period.
* Smoking
* Blood donation during the last two months and during the study.
* Food allergies or food intolerances
* CVD
* Metabolic diseases
* Inflammatory bowel diseases.
Transitioning to a Valve -Gated Intrathecal Drug Delivery System (IDDS)

Flowonix Prometra® II Programmable Pump may require a smaller dose of drug when converting from other commercially available intrathecal drug delivery systems (IDDS).

This open-label, non-randomized, single-blind, multi-center study is designed to evaluate effects of a planned 20% dose reduction when converting to valve-gated from a peristaltic pump. Study participants will be blinded (single blind) to the dose reduction aspect of this trial and must remain blinded to this dose reduction information throughout the trial in an attempt to provide an unbiased assessment of the pain encountered by the patient with their pain pump medications used.

This study will compare the historical pain medication dose and pain scores using the peristaltic pump at baseline as well as from the last pump refill visit prior to explant to the prospective pain medication dose and pain scores using the valve-gated pump and collected at refill visits 1, 2 and 3 after valve-gated pump implant (but not exceed 12 months).

Eligibility Criteria:
Inclusion Criteria:

1. Be male or female between the ages of 22 and 85 years
2. Be capable of giving informed consent and completing assessments required by the study
3. Have pain intensity of greater than 5 out of 10 as measured by VAS
4. Have an active existing peristaltic intrathecal drug delivery system
5. Have stable drug dosage for at least 6 weeks prior to valve-gated pump implant
6. Be an appropriate candidate for surgery
7. Be able to comply with required study visits and assessments including English proficiency

Exclusion Criteria:

1. Have a significant pain disorder not intended to be treated with the test device or comparator
2. Be terminally ill and/or have a life expectancy of less than 6 months
3. Be a pregnant/lactating woman or a woman of child-bearing potential
4. Have a systemic or local infection (contraindicated for pump implantation)
5. Have history/evidence of an active disruptive psychiatric disorder or other known condition with potential to impact compliance with study visits and assessments
6. Have an underlying condition increasing susceptibility to infection
Evaluation of the Picosure 755nm Alexandrite Laser With Lens Array for the Treatment of Acne Scars

The purpose of this study is to assess treatment of facial acne scars using the 755nm Alexandrite Laser with lens arrays.


Eligibility Criteria:
Inclusion Criteria:

1. Is a healthy male or female between 18 and 65 years old
2. Has unwanted acne scars, excluding ice pick scars (Deep atrophic scars that resemble poked holes), and wishes to undergo laser treatments.
3. Is willing to consent to participate in the study.
4. Is willing to comply with all requirements of the study including biopsies, being photographed, following post treatment care and attending all treatment and follow up visits.

Exclusion Criteria:

1. The subject is female and pregnant, has been pregnant within the last 3 months, is currently breast feeding or planning a pregnancy during the study period.
2. The subject is hypersensitive to light exposure OR takes photo sensitized medication.
3. The subject has active or localized systemic infections.
4. The subject has a coagulation disorder or is currently using anti-coagulation medication (including but not limited to heavy aspirin therapy {greater than 81 mg per day}).
5. The subject has any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this research study.
6. The subject is currently enrolled in an investigational drug or device trial, or has received an investigational drug or been treated with an investigational device within 3 months prior to entering this study.
7. The subject has used Accutane within 6 months prior to enrollment.
8. The subject has the need to be exposed to artificial tanning devices or excessive sunlight during the trial.
9. The subject has had prior treatment with parenteral gold therapy (gold sodium thiomalate).
10. The subject has a history of keloids.
11. The subject has evidence of compromised wound healing.
12. The subject has a history of squamous cell carcinoma or melanoma.
13. The subject has a history of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications.
14. The subject has an allergy to lidocaine and epinephrine.
Effect of Dexmedetomidine on Ischemia-Reperfusion Injury in Lower Extremity Operations

Ischemia reperfusion injury causes the release of free oxygen radicals. The selective alpha2-receptor agonist, dexmedetomidine, has an inhibitory effect on inflammatory responses during ischemic injury. The aim of this study is to evaluate the effect of dexmedetomidine on inflammatory responses during ischemia-reperfusion injury in skeletal muscle.


Eligibility Criteria:
Inclusion Criteria:

* American Society Anesthesiologists classification I-III

Exclusion Criteria:

* use of antioxidants clinically significant cardiovascular, renal, or hepatic diseases heart block greater than the first degree
Feasibility of a Water-soluble Contrast Application Into Dysphagia Evaluation

In traditional video-fluoroscopic-swallowing study, a lipid-soluble contrast (barium sulfate) has been used more than 30 years. However, it can cause chemical pneumonitis and subsequently impair reliability of video-fluoroscopic-swallowing study if aspirated. The authors reviewed the safety and usefulness of an water soluble agent-based swallowing test.

Parallel-group, case-controlled trial was conducted from September 2015 to November 2017. All the patients who referred for video-fluoroscopic-swallowing study were screened.

Based on the pre-emptive evaluation, high-risky patients were allocated to iohexol (Omnipaque)-used video-fluoroscopic-swallowing study and others were allocated to barium sulfate-used video-fluoroscopic-swallowing study.

Statistical Package for the Social Sciences 24 was used to perform statistical analysis for the data. Quantitative data were presented as mean ± standard errors.

Eligibility Criteria:
Inclusion Criteria:

* All the patients who referred for video-fluoroscopic-swallowing study

Exclusion Criteria:

* none
Computer-based Tutorial for the Informed Consent Process for Cataract Surgery in Turkish or Serbian Speaking Patients

Investigate if a computer-based tutorial enhances the quality and efficiency of the informed consent process for cataract surgery in Turkish or Serbian speaking patients.

Informing the patient and obtaining informed consent is one of the major duties physicians have to perform before beginning a medical treatment. However, patients often experience the informed consent taking as not satisfying. In the past, several approaches were used to try to improve the informed consent taking, such as printed information sheets and multimedia tools.

A novel concept introduced several years ago is to use a multimedia tool including a so-called traffic light system. The patient sees and hears information concerning cataract surgery on a touch screen and after each short chapter a traffic light is shown on the touch screen. At this point the patient has to decide, whether everything is clear and he wants to continue (green light), if he has further questions for the ophthalmologist (yellow light), or if he wants to repeat the chapter (red light). The patient's feedback for each chapter is then printed and guides the ophthalmologist during the face to face interview. This approach is called "CatInfo tool".

The German version of the CatInfo tool has been developed and evaluated in a previous study. In short, the CatInfo tool was developed as a multidisciplinary project including patients, graphic designers and ophthalmologists. The first version of the tool was evaluated in patient focus-groups. Afterwards, an evaluation study including 60 patients was performed. Main outcome was the following: patients who used the CatInfo tool were significantly better informed than patients only having a face to face interview with an ophthalmologist and the feedback concerning the CatInfo tool was good. Meanwhile the German version of the CatInfo tool is part of our daily routine and thousands of patients profited from the CatInfo tool consent always additional to the face to face interview with an ophthalmologist. However, some patients are not able to use the CatInfo tool. One reason is that they are not literate in German. Aim of this study is to translate and evaluate a Serbian and Turkish version of the CatInfo tool to allow better access.

Eligibility Criteria:
Inclusion Criteria:

* Cataract
* Age 21 and older
* First eye to be operated
* No previous ophthalmic surgery
* Written informed consent to participation in the study

Exclusion Criteria:

* Not literate in Serbian (Serbian group) / Turkish (Turkish group) or German (both groups)
* Visual acuity of less than 6/60 in the worse eye
* Severe hearing loss
* Inability to use touch screen device (e.g. severe tremor, etc.)
* Pregnancy - for women in the reproductive age a pregnancy test is required
Comparative Study of Tranexamic Acid, Estrogen for Treatment AUB in DMPA Users

Abnormal uterine bleeding is the most common problems to discontinue Depo-medroxyprogesterone acetate (DMPA) in Thailand. This clinical trial use to provide drug to stop abnormal uterine bleeding from DMPA

Abnormal uterine bleeding is the most common problems to discontinue Depo-medroxyprogesterone acetate (DMPA) in Thailand. After discontinue DMPA, patients have not used any method. Unwanted pregnancy are rising. The reason of abnormal uterine bleeding from DMPA aren't clearly understand. In present, no standard treatment to treat abnormal utrerine bleeding in DMPA users.This clinical trial use to provide drug to stop abnormal uterine bleeding from DMPA with minimal dose and minimal side effect

Eligibility Criteria:
Inclusion Criteria:

* Abnormal uterine bleeding more than 7 days after first DMPA injection
* Provide inform consent with patient
* Can understand thai language

Exclusion Criteria:

* Have contraindication to use Tranexamic acid and estrogen such as hypertension, Stroke, MI, DM, Renal disease, Liver disease, CA breast etc.
* Have pathology in uterus from pelvic examination, pap smear and ultrasound
* Current pelvic infection
* Postpartum less than 6 months
* History deep vein thrombosis
* Breastfeeding
Sarcopenia and Aging

Objective: Evaluate the muscular strength in the ageing process and identify the changes between the abdominal muscles, upper and louver edges.

Method: 48 individuals participated in this study, being divided into four groups according to the age: (G1) 11to 18 years old, (G2) 20 to 26 years old, (G3) 45 to 60 years old and (G4) 66 - 82 years old. The excluding criterion included people who work out more than three times a week, severe arthrosin, stroke, significant cognitive deficit , obesity, use of ortheses for louver members or any break, with or without metallic implant. The evaluation instruments used were: (1) Esfigmomanômetro (EM), (2) Trunk flexor in the supine position,, (3) Jamar Dinamômetro and (4) Preston Pinch Gauge Dinamômetro.

Forty-eight subjects participated voluntarily in this work and is divided into four groups of 12 participants with 6 men and 6 women: (G1) 11 to 18 years (G2) 20 to 26 years (G3) from 45 to 60 and (G4) 66 to 82 years, selected in dependency of Unifran and residences of the city of Franca, Sao Paulo - Brazil. To evaluate muscle strength, a BD sphygmomanometer was used to analyze the strength of flexors and extensors of the knee. The Jamar Dynamometer was used to assess the functional integrity of the upper and Preston Pinch Gauge Dynamometer for evaluation of gripper hands.

Eligibility Criteria:
Inclusion Criteria:

* absence of the basic pathology that interferes directly in the muscle

Exclusion Criteria:

* people who work out more than three times a week
* severe arthrosin
* stroke
* significant cognitive deficit
* obesity
* use of ortheses for louver members or any break
* with or without metallic implant
Perioperative Symptom Study of Lung Cancer (CN-PRO-Lung 1)

Investigators propose a multicenter prospective observational cohort study to develop and validate essential technical parameters for establishing the patient-reported outcome-based perioperative symptom management cohort in patients with lung cancer. With at least 300 patients with initial diagnosis of lung cancer and scheduled for surgery, this study will administer symptom assessments (MDASI-LC) and quality of life assessments (SIQOL) before surgery (typically within 3 days before surgery), daily after surgery (in hospital ≤ 14 days), and weekly after discharge, up to 4 weeks (±3 days) or the start day of postoperative oncologic treatment. In the upgraded research protocol, symptom and quality of life assessments (every 3 month for 1 year, every 6 month for 2-3 year, every 12 month for 4-5 year), as well as the follow-up of clinical outcomes will continue until 5 years after surgery.


Eligibility Criteria:
Inclusion Criteria:

1. Be pathologically or clinically diagnosed as primary lung cancer before surgery;
2. Plan to undergo a surgical procedure.

Exclusion Criteria:

1. Aged younger than 18;
2. Diagnosis of cognitive impairment or unable to understand the study requirements.
A Study to Evaluate the Safety, Tolerability and Efficacy of XEN1101 in Major Depressive Disorder

This is a multicenter, Phase 2, double-blind, randomized, parallel-arm, placebo-controlled clinical trial to evaluate the efficacy, safety, and tolerability of XEN1101 in subjects with Major Depressive Disorder.

The study is divided into 3 stages: Screening - up to 4 weeks duration; Treatment - 6 weeks duration; Follow-up - 4 weeks duration. The total study duration per subject is estimated to be approximately 14 weeks.

Eligibility Criteria:
Key Inclusion Criteria:

* Be properly informed of the nature and risks of the study and given written informed consent.
* Male or female, aged 18 through 65 years (inclusive) with a body mass index (BMI) ≤35 kg/m².
* Subject must meet the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for current MDD and currently in a moderate to severe major depressive episode (MDE), confirmed using the Mini International Neuropsychiatric Interview (MINI).
* Current MDE duration ≥2 months and \<24 months at the time of screening.
* Current illness severity that is at least moderate, defined as a score of ≥20 on the HAM-D17 at screening and on Day 1.
* Score ≥20 on the SHAPS at screening and on Day1.
* Must be willing to comply with the study protocol for the full term of the study.

Key Exclusion Criteria:

* A primary psychiatric diagnosis other than MDD as defined by DSM-5 (comorbid anxiety disorders \[including agoraphobia, generalized anxiety disorder, social anxiety disorder, post-traumatic stress disorder (PTSD), and panic disorder\] are allowed).
* Concomitant use of antidepressants and/or other disallowed pharmacotherapy (including benzodiazepines).
* History of schizophrenia or other psychotic disorder, MDD with psychotic features, bipolar I or II disorder, or MDD with mixed features.
* History of non-response to \>1 antidepressant drug due to lack of efficacy in the current MDE.
* Failing \>3 antidepressant drug trials, for any reason, in the current MDE.
* History of non-response to electroconvulsive therapy (ECT) in the past 10 years.
* Active suicidal plan/intent in the past 6 months, or more than 1 lifetime suicide attempt.
* Females who are pregnant, breastfeeding, or planning to become pregnant during the first administration of study drug until 3 months after the last dose of study drug.
* Meets criteria for a substance use disorder within the past 12 months, with the exception of tobacco use, and/or has a positive urine toxicology screen for drugs of abuse.
* Any medical condition or personal circumstance that, in the opinion of the investigator, exposes the subject to unacceptable risk by participating in the study or prevents adherence to the protocol.
Clinical Study to Evaluate the Efficacy of Blood Purification Therapy on Cholesterol Crystal Embolism

The aim of this study is to evaluate efficacy and safety of blood purification therapy on renal dysfunction by cholesterol crystal embolism.


Eligibility Criteria:
Inclusion Criteria:

Patients who meet all of the following criteria.

* Patients who had cardiac catheterization or vascular surgery in the last 24 weeks before the time of obtaining informed consent.
* Patients who satisfy all of the following criteria or are diagnosed as CCE by skin or renal biopsy.

  1. Patients with progressive renal dysfunction in the course of weeks or months.
  2. Patients with skin lesions such as livedo reticularis of lower extremities or blue toe syndrome.
  3. Eosinophil count is more than 400 per microliter.
* Patients who or patients whose legal representative understood the requirements of the study and signed the informed consent forms.

Exclusion Criteria:

Patients who meet any of the following criteria will be excluded.

* Patients with contraindication to anticoagulant (Nafamostat Mesilate).
* Blood purification therapy is inapplicable because of severe heart failure, acute myocardial infarction, severe arrhythmia, acute stroke, or severe uncontrollable hypertension or hypotension.
* Patients with body weight less than 40kg.
* Patients with a history of allergic reaction or hypersensitivity to blood purification.
* Patients who cannot stop taking ACE inhibitors.
* Patients with any disease in which corticosteroid, statin are contraindicated.
* Patients participated in another clinical trial or study at the time of obtaining informed consent.
* Patients receiving chronic hemodialysis.
* Otherwise, patients who are judged by the investigator as being unsuitable for inclusion in the study.
addressInG iNcome securITy in Primary carE

Social processes that impact the health of individuals have been labeled the social determinants of health (SDOH). These are "the conditions in which people are born, grow, live, work and age. These circumstances are shaped by the distribution of money, power and resources at global, national and local levels". Perhaps the most important SDOH is income security, a person's actual, perceived and expected income. Our objective is to carry out a pragmatic randomized controlled trial that evaluates the impact of an income-focused health promoter.

This study aims to answer the question: What is the impact of an income security health promotion service based in a primary care setting on the income security of people living in poverty? We hypothesize that an income security health promotion service for adults living in poverty will increase monthly income relative to usual care. We will carry out a pragmatic randomized controlled trial that evaluates the impact of such a new service focused on income security health promotion. The St. Michael's Hospital Academic Family Health Team has received ongoing funding from the Ministry of Health and Long-Term Care (MOHLTC) to support this service. The primary outcome is income security, and secondary outcomes include quality of life, financial literacy and community integration.

Population - Adults living in poverty Intervention - Income security health promotion Control - Usual care Outcome - Primary: Improvement in income per month in the intervention group at 6 months (post-intervention) compared to income in control group at 6 months (pre-intervention). Secondary: quality of life, self-rated health, community engagement.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18
* Lives within the Metropolitan catchment areas
* Lives in a postal code that is in the lowest income quintile, or has had a billing code specific to social assistance forms billed ever billed, or has been identified as low income based on reported family income and number of people supported by income on the "Health Equity Data"
* Patient of the Family Health team including those that are: rostered, non-rostered, refugee claimants (IFH) or uninsured seen in the FHT.
* Verified by the patient's family physician as living in poverty, a good candidate for the intervention, and the patient's family physician agrees to have a letter submitted with his/her name attached.

Exclusion Criteria:

* Patients who have previously worked with the Income Security Health Promoter, or are part of households of people who have previously worked with the Income Security Health Promoter.
* Patients who have no available contact information for mailing.
* Patients of any member of the investigative team.
Long Protocol and Growth Hormone in Poor Responders

The long down regulation protocol is widely used in the in vitro fertilization cycles, now it will be assessed regarding its efficacy, in poor responder females undergoing in vitro fertilization cycles, alone and after the addition of growth hormone.


Eligibility Criteria:
Inclusion Criteria:

* Poor responder females are those who posses two out of these three criteria:
* Female age ≥40 years
* Females who have at least one previous cancelled IVF cycle
* POR according to AFC ≤ 5 or low AMH value.

Exclusion Criteria:

* Females over 45 years
* Females with FSH more than 20 IU/l
* Females with previous ovarian surgery
* Females suffering from causes of infertility other than poor ovarian response
* Females refusing to be enrolled in the study
PegIntron Injection Surveillance Plan (Study P04123)

Surveillance will be conducted at digestive departments of internal medicine in university or general hospitals where participants with chronic hepatitis C are generally treated. The purpose of this surveillance is to evaluate the postmarketing safety and efficacy of PegIntron Injection under actual conditions of use and to examine adverse events, serious adverse events, and adverse drug reactions.

The investigator will record continuously from the first patient since the day of contract to the numbers of patients of contract based on Pegintron approval.

Eligibility Criteria:
Inclusion Criteria:

* Participants with chronic hepatitis C treated with peginterferon alfa-2b.

Signed written contract.

Exclusion Criteria:

* None