cyrilzakka/clinical-trials huggingface dataset:
Honest, Open, Proud - College for Post-Secondary Students with Mental Health Challenges

The purpose of the study is to evaluate the efficacy of an online format of the group-based intervention "Honest Open Proud-College" among Canadian post-secondary students.

Mental health issues have been highlighted as a growing concern within the post-secondary student population. Studies show that one significant concern for post-secondary students pertains to disclosing their mental challenges to others. Disclosure decisions are especially relevant for postsecondary students in the context of academic and social support. Students with mental health challenges who do not receive helpful accommodations may experience greater stress related to academics. Students also note that, in navigating their social sphere, they often need to consider what aspects of their mental health challenges to share in what situations.

As such, students often need to make decisions about whether to conceal or disclose their mental health challenges, both of which have their own pros and cons. Disclosure is a complex decision that requires consideration of personal and contextual factors. Honest, Open, Proud-College (HOP-C) is a peer-led, group-based intervention, that supports post-secondary students in the process of making decisions to disclose their mental health conditions. This study will evaluate the impacts of HOP-C administered through a videoconferencing platform on personal, social, and disclosure related outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Age 17 to 29 years old
* Enrolment in an university or college in Canada
* Self-identify as experiencing mental health challenges
* Moderate level of self-reported self-stigma (score 4 or higher on the screening item "Do you feel ashamed about dealing with anxiety, depression, or any other mental health challenges?", rated from 1, not at all, to 7, very much)

Exclusion Criteria:

-
Investigation of the HDAC4 Copy Number Variation and Its Effect on Gene and Protein Expression in Patients With ASD

Specific Aims of this study:

1. To understand the distribution of HDAC4 CNV in the families of the ASD patients with HDAC4 CNV;
2. To perform the analysis of gene expression;
3. To investigate the HDAC4 protein level expression;
4. To investigate the correlation of clinical/cognitive features with HDAC4 CNV, RNA and protein expression in ASD patients, and compare with their unaffected family members.

Autism spectrum disorder (ASD) is a common neurodevelopmental disorder affecting up to 1/50 in the world and 1% in Taiwan. ASD is a clinically and genetically heterogeneous complex disorder with high heritability. Due to its high prevalence, lifetime impairment and no effective prevention and treatment, ASD has been prioritized for molecular genetic study. Among the genetic findings based on our copy number variation (CNV) analysis of 335 patients with ASD, HDAC4 gene is selected to help us understand the pathogenesis of ASD by investigating parent-of-origin and the gene and protein expression of this gene, alongside neurocognitive and behavioral phenotypes.

Based on our findings on HDAC4 CNV analysis, the patients with HDAC4 CNVs (\~30 patients) and their families will be invited to participate the investigation of the CNV, RNA and protein expression analysis. Five healthy controls without any diagnosis of psychiatric disorders will be recruited to perform the comparison with ASD patients with HDSC4. The autistic symptoms and behavioral phenotypes assessed by the Chinese SCQ and SRS, and the cognitive function assessed by intelligence test and WCST will be used to reveal the associations among the CNVs, RNA expression, protein level and clinical/cognitive phenotypes.

According to our previous CNV findings at the HDAC4 locus, we expect to find CNV in HDAC4 variation in another independent sample of our ASD cohort and to explore how HDAC4 CNVs affect the RNA and protein expression of HDAC4. We anticipate our endeavors will provide the comprehensive profiles of the CNV, RNA and protein expressions and the clinical features of ASD patients with HDAC4 CNVs and contribute to our understanding of the pathogenesis of ASD.

Eligibility Criteria:
Inclusion Criteria:

* ASD group: Subjects who met the diagnostic criteria of either autistic disorder or Asperger's disorder defined by the DSM-IV criteria.

Exclusion Criteria:

* TD group: Subjects with any current or lifetime DSM-IV psychiatric disorders.
Perineural Platelet-rich Plasma for Diabetic Neuropathy Pain

Peripheral neuropathy is very common in diabetes mellitus (DM). Till now there is no available effective therapy for this pathology. Objective: To evaluate the clinical effect of perineural platelet-rich plasma (PRP) injection as a treatment of diabetic peripheral neuropathy (DPN).

Diabetic Peripheral neuropathy (DPN) is a common complication of diabetes mellitus (DM). Among several complications that contribute to reduce patient's quality of life and life expectancy diabetic neuropathy (DN) generalized or focal leads to an impaired life quality.

The clinical symptoms of DPN range from pain and burning sensations, more at rest or at night; to hypoesthesia or paresthesia, and or numbness.

Different types of peripheral neuropathy are observed in diabetes, axonal or demyelination or both can be present, involves myelinated and un-myelinated, large and small fibers. Nerve conduction studies can detect these changes. Till now, there is no effective therapy for the treatment of DPN.

Since 1950 Platelet-rich plasma (PRP) has been used in dermatology and oral maxillofacial surgery, but its role as an effective alternative treatment in many other clinical applications has been increased over the last years.

Platelets contain more than 1100 proteins, include enzymes, enzyme inhibitors, growth factors, immune messengers, and other bioactive compounds which play a role in tissue repair and wound healing.

Autologous platelet-rich plasma found to promote axon regeneration in studies involving animal models. Platelet derived angiogenesis factors are capable of stimulating new capillary growth by inducing migration of endothelial cells. It was suggested that this was the mechanism by which platelet factors influence the process of angiogenesis and revascularization.

Eligibility Criteria:
Inclusion Criteria:

* type II diabetes mellitus
* diabetic peripheral neuropathy
* six months duration of symptoms,

Exclusion Criteria:

* other causes of neuropathy
* patient refusal
* ulcers or amputations
* peripheral vascular diseases
* vertebral spine disease
* connective tissue disease
* platelet dysfunction syndrome
* critical thrombocytopenia
* local infection
* coagulopathy
Optimization of Osteoporosis Management Among Patients Older Than 45 Years Old With Low Energy Fracture.

Harrington's metaphorical depiction captures the essence of the problem : "Osteoporosis care of fracture patients has been characterized as the Bermuda Triangle made up of orthopaedists, primary care physicians and osteoporosis experts into which the fracture patient disappears".

The most effective way to achieve this goal is through implementation of coordinator-based post fracture models of care. Exemplar models have been refered to as "Fracture Liaison Service" (United-Kingdom \[1-3\], Europe \[4,5\] and Australia \[6-8\]) "Osteoporosis Coordinator Program" (Canada \[9,10\]) or "Care Manager Programs" (USA \[11,12\]).

The objective of this trial is to assess efficacy of a new coordinator-based post-fracture program in the Saint-Joseph Hospital in Paris to improve the management of osteoporosis after fracture thanks to an optimal recommendations practice to reduce the incidence of secondary fractures.

Men and women are included aged over 45 years with fragility wrist and hip fractures.

Evaluation criteria are based on the evidence-based assessment (stratify risk, identify secondary causes of osteoporosis, fracture evaluation), the medication adherence, others prescriptions adherence (osteodensitometry), the incidence of secondary fractures and number of falls.

Number of patients : 200 Duration of the study: 3 years Patients' participation duration: 6 months


Eligibility Criteria:
Inclusion Criteria:

* Men and women over 45 years
* Fragility wrist and hip fractures
* Volunteer

Exclusion Criteria:

* Public route accident
* Emergency illness associated
* Short life expectancy
* Not volunteer
* Bedridden patient
Chronic Liver Disease in Urea Cycle Disorders

This is a pilot, cross-sectional study to assess liver stiffness and markers of hepatic injury, function, and fibrosis in patients with urea cycle disorders. This study will be conducted at 3 UCDC sites: Baylor College of Medicine in Houston, Texas, University of California San Francisco (UCSF), San Francisco, California and Seattle Children's Hospital, Seattle,Washington

Urea cycle disorders (UCDs) are among the most common inborn errors of liver metabolism.With early diagnosis and improved treatments, the survival of individuals with UCDs has improved, and this improved survival has led to unmasking of some long-term complications such as hepatic dysfunction and progressive fibrosis in a subset of patients. Hepatic complications in UCDs are quite variable and dependent upon the specific metabolic defect. Currently, there are no guidelines for monitoring hepatic complications or extent of liver disease in UCDs.

The purpose of this study is: 1) To determine whether liver stiffness is higher in individuals with ASS1D, ASLD, and ARG1D as compared to females with OTCD, and to assess liver stiffness in other UCDs (citrin deficiency, NAGSD, CPS1D, and males with OTCD), 2) To test whether markers of hepatocellular injury and function and novel serum biomarker panels for hepatic fibrosis provide evidence of chronic liver disease in individuals with ASS1D, ASLD, and ARG1D as compared to OTCD and to assess these sample markers of hepatocellular injury and function and novel serum biomarker panels for hepatic fibrosis in other UCDs (citrin deficiency, NAGSD, CPS1D, and males with OTCD).

Eligibility Criteria:
Inclusion Criteria:

1. Age \> 5 years and \< 60 years
2. Weight ≥ 11 kg
3. Males or females with a diagnosis of OTCD based on molecular or enzymatic testing. Males or females with a diagnosis of CPS1D, citrin deficiency, NAGSD, ASS1D, ASLD or ARG1D based on biochemical OR molecular, OR enzymatic testing

Exclusion Criteria:

1. History of hyperammonemia (blood ammonia greater than 100 micromoles/L) documented in the medical record or reported by the patient in the 30 days preceding enrollment visit
2. History of Liver transplantation
3. Current pregnancy
4. Confirmed diagnosis of chronic viral hepatitis, autoimmune liver disease, or alcohol liver disease
Effect of Remote Ischemic Conditioning on Trauma Patients With Hemorrhagic Shock

The purpose of the study is to evaluate whether remote ischemic conditioning is a safe and effective intervention to prevent the development of inflammation and coagulopathy in trauma patients with hemorrhagic shock.

Dysfunction of vital organs is one of the major reasons why trauma victims die after sustaining a major injury, even though the organs themselves may not have been directly injured. The inability to clot blood as a result of inflammation further contributes to complications in a majority of these patients. One intervention proposed to protect against impaired organ function is called "Remote Ischemic Conditioning", wherein application of intermittent occlusion and release of blood flow to the arm by sequentially inflating and deflating a blood pressure cuff can protect against the development of distant organ injury and inflammation following a severe traumatic event. In a pilot study, we will investigate the effects of remote ischemic conditioning in trauma patients with hemorrhagic shock, with a view to evaluate its effects on the immune system and coagulation profiles, both of which are known to be deranged in these patients. These studies will potentially benefit patients and will serve as a proof of principle for the use of remote ischemic conditioning in the trauma setting.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥16 years of age or estimated weight ≥50kgs if age is unknown;
* Victim of blunt or penetrating trauma
* Hemorrhagic shock defined as:
* One or more episodes of systolic blood pressure ≤90mmHg at any time prior to enrollment into the study;
* An identified source of blood loss (abdomen, chest, pelvis/retroperitoneum, extremities, external) or
* Blood products (RBC, Platelets, Plasma, etc.) has been ordered to the trauma room.
* Admitted to St. Michael's Hospital directly from the scene of injury within 3 hours of the injury
* Application and completion of Remote Ischemic Conditioning (RIC) within 4 hours of the injury

Exclusion Criteria:

* Pregnancy
* Non-hemorrhagic shock (i.e. tension pneumothorax, cardiac tamponade, spinal shock, etc.)
* Major burns \> 20% total body surface area
* Fracture of both lower extremities (i.e. traumatic amputation, fractures)
* Absence of vital signs prior to admission, ongoing CPR, possibly dead on admission or not expected to survive beyond a few hours.
* Injury in both legs (traumatic amputation, fractures, etc.)
* Patients with a systolic blood pressure above 200mmHg
* Patients treated with anticoagulants, antiplatelet therapy (Warfarin, Aspirin), steroids or with a known bleeding disorder or known abnormality of blood flow to the limb (if known)
* Patients with osteoporosis or other bone disorders, peripheral nerve injury, abnormal nerve supply, peripheral neuropathy (if known) or preexisting traumatic injury to the limb.
* Morbid obesity (largest cuff size won't fit)
* If RIC is done clinically before research protocol begins.
Positive Predictive Value (PPV) of Pseudomonas Aeruginosa

This is a non-randomized, single-blind post market clinical follow-up study for which 65 patients will be imaged at Rouge Valley Centenary Hospital (Scarborough and Rouge Hospital) who present with a chronic wound and are receiving standard wound care treatment. The MolecuLight i:X imaging device will be used by the study clinician as an adjunctive tool in the assessment of the wound and will be used to guide the targeted sampling of a wound (with curettage scraping), as per current standard of care in the principal investigator's wound care clinic. The acquired tissue sample will then be analysed using conventional gold standard semi-quantitative culture methods to determine bacterial species present, also as per current standard of care in this clinic.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female patients presenting with a chronic wound (wound duration \> 4 weeks) e.g. diabetic foot ulcer, venous leg ulcer, pressure ulcer, or other acceptable aetiology
2. 18 years or older

Exclusion Criteria:

1. Treatment with an investigational drug within 1 month before study enrolment
2. Inability to consent to medical photography (i.e. inability to understand consent process)
3. Any contra-indication to routine wound care and/or monitoring
4. Prior participation of the patient in this study (for the same wound or a different wound).
CardioMEMS HF System Coverage with Evidence Development Study

The purpose of the CardioMEMS CED Study is to determine if pulmonary artery (PA) pressure-guided heart failure management using the CardioMEMS™ HF System improves long-term health outcomes in heart failure (HF) patients in the real-world setting.

The CardioMEMS CED Study will assess 2-year HF hospitalization rates and survival for all-cause mortality in heart failure subjects managed with the CardioMEMS HF system, as compared to a contemporaneous control of HF subjects managed without PA pressure-guidance.

Eligibility Criteria:
Inclusion Criteria:

1. Subject implanted with a CardioMEMS pressure sensor (treatment arm only)
2. Subject \>=18 years of age at time of implant
3. Subject has a history of acute decompensated HF or HF-related congestion defined by at least one of the following qualifying event types: HF hospitalization, elevated BNP/NT-proBNP

Exclusion Criteria:

1. Subject has history of heart transplant or durable mechanical circulatory device
2. Subject hospitalized with cardiogenic shock or sepsis
3. Subject received prior PA pressure sensor implant (control arm only)
CAEB071 Thorough QTc Study in Healthy Volunteers

This study has been designed in compliance with the ICH-E14 guideline 2005 to evaluate the QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female subjects age 18 to 50 years (including both) of age included, and in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening.

Exclusion Criteria:

* Smokers and tobacco product users (in the previous 3 months).
* Use of any prescription drugs, herbal supplements, within four (4) weeks prior to initial dosing, and/or over-the-counter (OTC) medication, dietary supplements (vitamins included) within two (2) weeks prior to initial dosing.
* A marked baseline prolongation of QT/QTcF interval
* Presence of clinically significant illness
* Other protocol-defined inclusion/exclusion criteria may apply
Prenatal Probiotic Intervention

This study will assess the feasibility of a randomized control trial in which the effects of probiotic supplementation throughout pregnancy on maternal insulin sensitivity and inflammation, as well offspring gene expression and body composition are examined.

Maternal obesity leads to increased insulin resistance and inflammation which have been shown to induce fetal adaptations and greater risk of obesity in the offspring. Probiotic supplementation during pregnancy has been shown to improve insulin sensitivity in normal weight women. However, little is known on the effects of probiotic supplementation throughout pregnancy on maternal insulin sensitivity and inflammation as well as offspring gene expression and body composition. Long term nutritional supplementation, however, is associated with increased participant burden as well as lower compliance and retention rates. Thus, this study will assess the feasibility of a long term probiotic supplementation study in obese pregnant women. Acceptance and compliance with daily capsules throughout pregnancy and study procedures will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* BMI ≥ 30
* ≥ 18 years of age
* Singleton pregnancy
* Less than 12 weeks of gestation
* Less than 1 serving of yoghurt with live cultures or cultured milk per week
* Conceived without assisted fertility treatments

Exclusion Criteria:

* • Women with pre-existing medical conditions (e.g., diabetes, hypertension, thyroid disorders, heart disease or immune disorders) as determined by the PI to affect the outcomes of interest

  * Immunosuppressed women
  * Women taking medications during pregnancy known to affect fetal growth (i.e., thyroid hormone, glucocorticoids, insulin, oral hypoglycemic agents)
  * Women who are using recreational drugs, tobacco or alcohol during their pregnancy
  * Milk intolerance or allergy
  * Consuming probiotic supplements
StatStrip Lactate, Hemoglobin, and Hematocrit Meter in Whole Blood

The purpose of this study is to evaluate the clinical utility of the StatStrip Lactate, Hemoglobin and Hematocrit Hospital Meter System in the testing of whole blood specimens from patients in hospital settings by CLIA waived operators, over a period of at least twenty days. The specimens shall include capillary (obtained by fingerstick), and venous whole blood. The study will also evaluate the use of a Fingerstick Blood Contamination Barrier for capillary sampling from the fingertip. This submission to the FDA is intended for a Point of Care (POC), CLIA waived device for whole blood capillary and venous lactate, and hemoglobin and hematocrit measurements.

The study will be conducted at three (3) different healthcare settings (hereafter referred to as "testing sites") in POC sites/departments, by at least nine (9) CLIAW operators (at least 3 in each healthcare setting), over a period of at least twenty days at each healthcare setting. Examples of hospital departments include (but are not limited to) Emergency Department (ED), Intensive Care Unit (ICU), Pediatric Intensive Care Unit (PICU), Surgical Intensive Care Unit (SICU), Medical Intensive Care Unit (MICU), Cardiac Intensive Care Unit (CICU), Operating Room (OR), where point-of-care lactate, hemoglobin and hematocrit testing can be utilized.

Each site will recruit at least 120 patients for a total of 360 adult patients in all three (3) sites for each of the tests and specimen types. An attempt will be made to enroll 50% males and 50% females.

Each Study Subject will provide:

1. Two (2) capillary whole blood fingerstick specimens

   1. One Lactate capillary test using the Fingerstick Blood Contamination Barrier
   2. One Hb/Hct capillary test following traditional fingerstick protocol
2. One (1) venous whole blood specimen obtained by venipuncture collected in a lithium heparin tube or heparinized syringe:

   1. One lactate venous test
   2. One Hb/Hct venous test

Eligibility Criteria:
Inclusion Criteria:

* Adult subjects (over or equal to 18 years old) with ordered hemoglobin and hematocrit

Exclusion Criteria:

* Pediatric