[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Dalhousie University\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":259},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,46,79,109,138,167,201,228],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":26,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":4},"100638583","moving-forward-with-menopause-treatment-through-pharmacists-expanded-roles-in-hormone-health-100638583",false,"NCT07618039","MOving Forward With MENopause Treatment Through Pharmacists' Expanded Roles in Hormone Health","MOMENT","Inclusion Criteria:\n\nPharmacist (pharmacies) participants:\n\n* Select community pharmacies with an appointment based system as chosen in consultation with PANS.\n* Pharmacist participants must be licensed to practice direct patient care in Nova Scotia.\n* Pharmacist participants must have completed the MOMENT education and training.\n\nPatient participants:\n\n* Resident of Nova Scotia with a provincial MSI card.\n* People with the anatomical and physiological components (AFAB) that would predispose them to signs and symptoms of menopause that are associated with decreasing hormones (e.g., estrogen).\n* Signs and\u002For symptoms of the menopause and the person is seeking care for the same, regardless of whether they are using treatments.\n\n  * The potential participants will screen using MQ6 questions based on: 1) changes in periods; 2) presence of hot flashes; 3) vaginal dryness, pain, or sexual concerns; 4) bladder issues or incontinence; 5) new sleep difficulties; 6) new or increased anxiety, irritability, depression or low mood.\n\n    * People with symptoms in 2, 3, or 4 indicate symptoms for which MHT may be indicated and are eligible to be included for the study.\n    * People with only number 1 should talk with the pharmacist to determine if these symptoms are related to menopause and what the menstrual changes are (i.e. frequency, volume, regularity, duration, non-menstrual bleeding, bleeding outside of the reproductive age, acute or chronic bleeding). If there is evidence of other signs and symptoms of menopause on assessment, they can be included. If no other signs or symptoms related to menopause are present, people will be referred back to their regular primary care provider, if the person has one. If not, the pharmacist will provide the person with information on care options (e.g., https:\u002F\u002Fwww.nshealth.ca\u002Fwheretogoforhealthcare).\n    * People only with 5 can be considered as part of common ailments prescribing (existing scope within the Standards of Practice for Prescribing Drugs), if appropriate, and will be included in the study only if other signs and symptoms of menopause are present.\n    * People only with number 6 will be assessed regarding their symptoms. If no other signs or symptoms related to menopause are present, people will be referred back to their regular primary care provider, if the person has one. If not, the pharmacist will provide the person with information on care options (e.g., https:\u002F\u002Fwww.nshealth.ca\u002Fwheretogoforhealthcare) and options for mental health care if deemed appropriate (https:\u002F\u002Fmha.nshealth.ca\u002Fen). Additionally, the pharmacist can determine if there are options within their existing scope to provide care to the patient, if appropriate, and also refer the patient to a Bloom Program pharmacy if deemed appropriate.\n* Perimenopausal people who previously had symptoms of menopause and were also receiving hormonal contraceptives but warrant a transition to MHT based on clinical factors (e.g., older age, reached menopause).\n\nExclusion Criteria:\n\nPatient participants:\n\n* People with surgical menopause via oophorectomy.\n\n  o Patients who have had oophorectomy experience early menopause (i.e., surgical menopause). These patients are most likely to have previously received or currently be receiving systemic treatment with MHT. If this was not the case, pharmacists will refer the patient back to their regular primary care provider, if the patient has one. If not, the pharmacist will provide the person with information on care options (e.g., https:\u002F\u002Fwww.nshealth.ca\u002Fwheretogoforhealthcare).\n\n  o If the pharmacist deems that a renewal of previous MHT is appropriate, they will use their clinical discretion and follow their legal and ethical obligations as per usual when engaging in this activity.\n* People with a final menstrual period (FMP) \\\u003C 40 years or \"early menopause\" (FMP \\\u003C45 years).\n\n  o additional investigation is required to explore underlying causes related to their menstrual cessation (e.g., hypothalamic-pituitary-ovarian axis conditions or other possible causes). People in this category will be referred back to their regular primary care provider, if the person has one. If not, the pharmacist will provide the person with information on care options (e.g., https:\u002F\u002Fwww.nshealth.ca\u002Fwheretogoforhealthcare). Typically, people in this situation are typically treated with hormones to around the age of 51 (i.e. typical age of menopause).\n\n  o Note: a person that had premature or early menopause and has progressed beyond the typical age of treatment for replacement of hormones (i.e., 51), and is currently experiencing signs and symptoms via screening, can be considered for inclusion.\n* Perimenopausal people who are seeking contraception prescribing.\n\n  o Pharmacists should engage in prescribing for contraceptive management as per the Nova Scotia College of Pharmacists Standards of Practice for Prescribing Drugs.\n* People who are stable on existing MHT and other therapies to manage menopausal symptoms and no changes are required.\n* People who only require a renewal, adaptation, or therapeutic substitution for a menopausal treatment. These activities fall within pharmacists' existing scope.\n\n  o Exception: people who do not have a doctor or nurse practitioner are eligible for inclusion if the pharmacist has been providing these prescribing services.\n* GSM induced by testosterone therapy for gender affirming care. o Transmasculine or gender diverse individuals using testosterone therapy with GSM induced by testosterone therapy (these people should be managed in collaboration with their gender affirming care providers).\n* The person cannot consent for themselves for the study due to cognitive impairment (e.g., advanced Alzheimer's disease or other dementias).\n\nConsiderations related to inclusion and exclusion criteria:\n\n• Older age: older age is not necessarily an exclusion criteria but will have a role as \"a flag\" in clinical assessment.\n\no People AFAB who are \\> 10 years after their FMP or \\> 60 years of age are not globally initiated on systemic MHT if they have have symptoms and have never had MHT before. However, there must be a benefit-risk discussion with the person regarding the treatment options if treatment is being sought, and therapies must be individualized. Although, \"second-line\", there are other systemic non-MHT options available for symptom management and other treatments (e.g., localized treatments such as intravaginal hormones for GSM). Regardless of the treatment, a benefit-risk discussion is required with the person AFAB.",true,"FEMALE",{"count":19,"type":20},200,"ESTIMATED","OBSERVATIONAL","The MOMENT project centres pharmacists as key partners for people assigned female at birth (AFAB) in improving menopause care. Menopause is a major life event, which half of our population will experience. For many, the mental and physical symptoms of menopause can impact quality of life, relationships, and workplace productivity. There are significant inequities in menopause health care and knowledge gaps for health care providers and the public with menopause being poorly understood. Menopausal Hormone Therapy (MHT) and related treatments are under-utilized and symptom control for people AFAB is often suboptimal. Since the publication of the Women's Health Initiative (WHI) study of postmenopausal women in 2002, menopausal care changed and misinformation about the risks versus benefits of MHT continue to create fear in those AFAB and health care providers. Guideline-concordant care includes MHT as first-line therapies for symptoms and there is increasing interest to improve the care of menopausal people. When MHT is not appropriate, there are other non-hormonal options that are available.\n\nWhat do pharmacists already legally do in Nova Scotia for hormone therapies and other treatments commonly used for menopausal management for those assigned female at birth?\n\n* Hormones and non-hormonal therapies: Pharmacists receive prescriptions for and dispense MHT and other therapies related to menopausal symptoms, and as per the Standards of Practice, assess appropriateness of all prescriptions for patients, which includes, but is not limited to, assessing indications, contraindications, dosing and intervals, drug interactions (drug-drug, drug-disease, drug-food, etc.), and providing education on the medication, including but not limited to its proper use and storage, expectations of side effects and benefits, how to monitor progress, and when to follow-up and seek help. Pharmacists have a relationship and responsibility to patients for shared decision making. This requires that they know the benefits (e.g., symptom reduction, health outcome reduction or improvement) and risks (e.g., adverse effects, contraindications, drug interactions) of hormones, and in the specific patient context.\n* Pharmacists can prescribe MHT and other non-hormonal therapies with a diagnosis as set out in collaboration with another health care professional (e.g., physicians, nurse practitioners) as per the existing legal framework in Nova Scotia.\n* Pharmacists provide ongoing care and monitoring throughout a patient's medication journey.\n* Pharmacists engage in prescribing renewals and therapeutic substitutions. They assume the prescribing responsibility when deciding to lengthen the time a patient can receive the prescription after it was initially prescribed by another prescriber, and when changing, adapting, or substituting medications as clinically indicated.\n* Pharmacists prescribe hormones for contraception.\n* Pharmacists can also prescribe non-MHT medications for other conditions related to menopause (e.g., insomnia) and recommend nonpharmacological interventions (e.g., cognitive behavioural therapy for insomnia, CBTi) as this is already part of the scope of practice.\n\nWhat is the project proposing? This project will focus on initiation of treatments for menopausal symptoms (e.g., MHT and other guideline-concordant treatments) for AFAB participants as a part of menopause signs' and symptoms' management and adds initiation to other participant pharmacist prescribing responsibilities as described above.\n\nThe Pharmacy Association of Nova Scotia will facilitate communications to pharmacies and pharmacists, to request participation in the project. This will go to community pharmacies that have a practice setting that includes dedicated time for appointment-based prescribing services. For brevity, the investigators refer to these as appointment-based pharmacies (ABPs). The additional prescribing responsibilities will be facilitated through the existing legal framework in Nova Scotia. This means that it would be considered \"Prescribing in Accordance with an Approved Research or Pilot Protocol\" according to the existing regulatory framework within the Nova Scotia Pharmacy Regulator.\n\nThe project includes mixed methods with quantitative and qualitative approaches. The main sources of data will be anonymized data capture by pharmacist participants, surveys of both pharmacist participants and patient participants, and interviews of both groups of participants (i.e., pharmacist participants and patient participants).\n\nInitiating treatments for menopause based on the current scope of practice is a natural progression of the scope of pharmacists' practice. It provides the opportunity to improve the health of those with menopausal signs and symptoms. The project can explore feasibility of an additional MHT prescriber in the health system and whether scale and spread should be explored further.",[24,25],"Menopause","Pharmacists",[27,28,29,30,31,32,33],"pharmacists","menopause","implementation","access","menopause hormone therapy","genitourinary syndrome of menopause","vasomotor symptoms","NOT_YET_RECRUITING","2026-05-26",{"date":37,"type":38},"2026-06-01","ACTUAL",{"date":40,"type":20},"2026-07-01",{"date":42,"type":20},"2027-12-31",{"name":44,"class":45},"Dalhousie University","OTHER",{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":54,"minAge":55,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":58,"phases":59,"briefSummary":61,"conditions":62,"keywords":65,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":78},"100619425","supporting-the-transition-to-parenthood-through-online-sex-and-relationship-knowledge-100619425","NCT07344454","Supporting the Transition to Parenthood Through Online Sex and Relationship Knowledge","STORK (Supporting the Transition to Parenthood Through Online Sex and Relationship Knowledge) Randomized Controlled Trial","STORK","Inclusion Criteria:\n\n* married or cohabitating romantic relationship of at least 12 months\n* one member of the couple must be currently pregnant (13-27 weeks gestation) with their first baby together (If the couple has a history of miscarriage or stillbirth, previously gave a baby up for adoption, or have other children who do not live with them, they are still eligible to participate.)\n* low-risk pregnancy\n* live in Canada, the United States, Australia, New Zealand, the Republic of Ireland, or the United Kingdom\n* able to read and understand English\n* have access to a personal e-mail account\n\nExclusion Criteria:\n\n* severe relational distress or conflict as determined by baseline measures\n* one or both partners of a couple do not complete the baseline survey - this includes cases where one or both partners do not pass at least 3\u002F5 attention checks in the baseline survey\n* instructed to avoid sexual activity from a healthcare professional","ALL","18 Years",{"count":57,"type":20},268,"INTERVENTIONAL",[60],"NA","Becoming parents exerts powerful and long-lasting effects on couples' well-being and quality of life. The transition to parenthood (TtP; pregnancy to 12-months postpartum) poses significant challenges as couples balance the task of caring for a newborn while maintaining their romantic relationship. One crucial way that couples sustain their connection is through their sexuality. Most new parents experience significant disruptions to their sexual well-being (i.e., sexual satisfaction, desire, distress), with sexual concerns such as reduced sexual frequency and lack of time and energy for sex being nearly ubiquitous. Simultaneously, most new parents lack easily accessible, reliable information on the common sexual changes associated with the TtP and there is a lack of evidence-based research aimed at helping couples navigate changes to their sexual well-being across this life transition. The investigators have identified risk (e.g., stress) and protective (e.g., intimacy) factors for couples' sexual well-being across the TtP that can be targeted in a prevention program, though no such programs exist.\n\nThe goal of this two-centre randomized controlled trial is to evaluate the efficacy of STORK (Supporting the Transition to Parenthood through Online Sex and Relationship Knowledge), a novel couple-based online program to support new parents' sexual well-being. This program comprises psychoeducation about common sexual changes as well as skills that couples can develop together to manage these changes and constitutes the first evidence-based program for new parent couples' sexual well-being. The investigators expect that, compared to a waitlist control group, couples who complete STORK will have better sexual, relational, and psychological adjustment across the transition to parenthood (from 13 to 27-weeks gestation to 12-months postpartum). Given that up to 78% of new parents report receiving little-to-no information about what to expect regarding changes to their postpartum sexual relationship, this study addresses the need for accessible, couple-based supports for this commonly challenging transition. By strengthening couples' sexual relationships, the results of this research have the potential to promote the quality of new parents' relationships, strengthening the overall well-being of their families during this critical life stage.",[63,64],"Pregnancy","Postpartum",[66,67,68,69],"Transition to parenthood","sexual well-being","couples","parents","2026-01-15",{"date":72,"type":38},"2026-01-16",{"date":74,"type":20},"2026-01",{"date":76,"type":20},"2029-03",{"name":44,"class":45},2,{"id":80,"slug":81,"hasResults":11,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":4,"eligibilityCriteria":85,"healthyVolunteers":16,"sex":54,"minAge":55,"maxAge":86,"enrollmentInfo":87,"targetDuration":4,"studyType":58,"phases":89,"briefSummary":91,"conditions":92,"keywords":94,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":4},"100616407","phase-1-establishing-a-controlled-human-infection-model-for-influenza-h3n2-as-a-foundation-for-pandemic-preparedness-100616407","NCT07305207","Establishing a Controlled Human Infection Model for Influenza H3N2 as a Foundation for Pandemic Preparedness","A Double-blinded, Phase 1 Clinical Trial to Establish an RG-A\u002FTexas\u002F71\u002F2017 (H3N2) Influenza Controlled Human Infection Model (CHIM) That Safely and Reproducibly Induces Symptomatic Influenza Virus Infection in Healthy Adults 18-45 Years of Age After Intranasal Challenge","Inclusion Criteria:\n\n1. Written informed consent obtained from the participant.\n2. 18-45 years of age.\n3. Good general health status, as determined by history and physical examination conducted no longer than 30 days prior to the challenge date.\n4. HAI antibody titer ≤1:40 against influenza A\u002FTexas\u002F71\u002F2017 (H3N2).\n5. Eligibility laboratory values\\* (complete blood cell count with differential (CBC-D), biochemistry (creatinine (Cr), total bilirubin, blood urea nitrogen (BUN), aspartame aminotransferase (AST), alanine transaminase (ALT), and c-reactive protein (CRP))\\*Labs within normal range or grade 1 abnormalities deemed not clinically significant by a study investigator are considered acceptable.\n6. Vital signs\\*\\* as follows:\n\n   1. Pulse is 47 to 99 beats per minute\n   2. Systolic blood pressure is 85 to 139 mmHg\n   3. Diastolic blood pressure is 55 to 89 mmHg\n   4. SpO2 ≥ 95%; RR ≤ 18\n   5. Oral temperature is less than 38.1°C \\*\\*Clinical judgement when characterizing vital signs will be used in the context of certain populations according to the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (e.g. conditioned athletes, white coat hypertension etc.)\n7. If a person is at risk of becoming pregnant, has practiced adequate contraception for 28 days prior to challenge, and has a negative pregnancy test on the screening day and the day before influenza A\u002FH3N2 challenge (Check-in Day) and has agreed to continue adequate contraception until 60 days after challenge.\n\n   Risk of pregnancy is defined as any individual assigned female at birth or with reproductive capacity who is sexually active with individuals with sperm-producing capabilities. Individuals who have received the following are considered to not have reproductive capacity:\n   * Documented hysterectomy\n   * Documented bilateral salpingectomy\n   * Documented bilateral oophorectomy\n   * Documented and current bilateral tubal ligation or occlusion\n   * Credible self-reported history of diagnosed infertility\n   * Hormone therapy (e.g. testosterone), provided it is administered consistently and medically assessed as sufficient to reduce pregnancy such that ovulation has ceased\n   * Any other condition, as determined by the Principal Investigator\u002Fstudy physician, that would render an individual incapable of becoming pregnant\n\n   Adequate contraception is defined as a contraceptive method with a failure rate of \\\u003C1% per year when used consistently and correctly and, when applicable, in accordance with the product label. Examples include the following:\n   * Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal, or transdermal\n   * Progestogen-only hormonal contraception associated with inhibition of ovulation: oral, injectable, or implantable CI2403.03November2025\\_V3.0 52\n   * Intra-uterine device (IUD) with or without hormonal release\n   * Vasectomized partner, if this is the participant's sole partner and the partner has received a medical assessment of the surgical success\n   * Credible (as deemed by the Investigator\u002Fstudy physician) self-reported history of abstinence for at least 28 days prior to challenge\n8. Participants who, in the opinion of the Investigator\u002Fstudy physician, can and will comply with the requirements of the protocol (e.g., inpatient stay, complete eDiary Cards, return for follow-up visits).\n\nExclusion Criteria:\n\n1. Underlying chronic medical condition requiring ongoing follow-up and monitoring by a physician (e.g., diabetes, seizure disorder).\n2. Underlying renal disease or disorders requiring ongoing follow-up and monitoring by a physician. In the event a participant has a minimally elevated BUN and\u002For Cr at screening, the participant will either be excluded or an eCRF or creatinine clearance may be conducted to determine eligibility.\n3. Underlying coagulation disorder history. In the event a participant reports a personal history of undiagnosed prolonged bleeding and\u002For recurrent nosebleeds or a personal or family history of coagulation disorders, a bleeding panel (PTT, INR, fibrinogen) will be used to rule out coagulopathy.\n4. Underlying cardiac conditions including:\n\n   1. Hypertension, angina, or prior myocardial infarction\n   2. Structural or functional cardiac disease (e.g., dilated cardiomyopathy, congestive heart failure)\n   3. With a history of arrhythmias\u002Fdysrhythmias (e.g., torsades de pointes, atrial fibrillation)\n   4. Cardiac conduction abnormalities (e.g., congenital or acquired heart block)\n   5. Uncorrected or ongoing serum electrolyte abnormalities (e.g., hypokalemia, hypomagnesemia, hypocalcemia)\n5. Underlying pulmonary disease including asthma, emphysema, chronic bronchitis, pulmonary tuberculosis or any other structural or functional pulmonary condition (e.g., history of severe airway hyper-responsiveness).\n6. FEV1\u002FFEV6 \\\u003C 0.73 as an indication of potential airflow limitation.\n7. Known allergy to excipients in the challenge virus inoculum and placebo. The excipient (diluent and placebo) is SPG: sucrose, KH2PO4, K2HPO4, L-glutamic acid.\n8. Moderate or severe symptoms of health anxiety, anxiety, and mood symptoms. Self-reported current diagnosis of a major psychiatric illness, including, but not limited to, a schizophrenia spectrum disorder, bipolar disorder, posttraumatic stress disorder, obsessive compulsive disorder, substance use disorder, or eating disorder, based on standardized mental health screening tools.\n9. Habitual\\*\\*\\* smoker of tobacco, e-cigarettes or marijuana. \\*\\*\\*Habitual smokers are those who smoke more than four cigarettes, other tobacco products, e-cigarettes (to include vaping and Juuling products) or marijuana in a week and cannot agree to abstain from smoking cigarettes, other tobacco products, e-cigarettes and\u002For marijuana products during participation in the study.\n10. Any current daily use of illicit drugs whereby the individual and\u002For study staff assess that the individual cannot abstain from during the isolation period.\n11. Any current daily alcohol consumption whereby the individual and\u002For study staff assess that the individual cannot abstain during the isolation period.\n12. History of allergic rhinitis and\u002For any condition that causes similar symptoms, including chronic cough.\n13. Pregnant (known before or established at the time of screening using a urine pregnancy test) or breastfeeding.\n14. Immunocompromised (with HIV\u002FAIDS or receiving immunosuppressive therapy involving steroids) or any medical condition or medication that leads to a compromised immune system.\n15. Screening blood work positive for HBV, HCV, or HIV.\n16. Influenza virus detected in NPS sample prior to challenge using RT-qPCR and\u002For culture isolation, or detection of other respiratory infection.\n17. Received influenza vaccination within the last 4 months prior to screening based on history described by participant or planned receipt up to Study Day 57.\n18. Living with, working with, or in close contact with children less than 6 months of age, or a household member(s) highly recommended to receive an annual influenza vaccination by NACI\\*\\*\\*\\* and that have not been immunized with influenza vaccine within the last year or immunized less than 3 weeks prior to challenge.\n\n    \\*\\*\\*\\*Individuals that are highly recommended by NACI to receive an influenza vaccine and potentially at risk include the following (52): (52):\n    1. All children 6-59 months of age\n    2. Adults and children with the following chronic health conditions:\n\n    i. Cardiac or pulmonary disorders (including bronchopulmonary dysplasia, cystic fibrosis and asthma) ii. Diabetes mellitus and other metabolic diseases iii. Cancer, immune compromising conditions (due to underlying disease, therapy, or both, such as solid organ transplant or hematopoietic stem cell transplant recipients) iv. Renal disease v. Anemia or hemoglobinopathy vi. Neurologic or neurodevelopmental conditions (includes neuromuscular, neurovascular, neurodegenerative, neurodevelopmental conditions and seizure disorders \\[and, for children, includes febrile seizures and isolated developmental delay\\], but excludes migraines and psychiatric conditions without neurological conditions) vii. Morbid obesity (defined as Body Mass Index (BMI) ≥ 40 kg\u002Fm2) viii. Children six months to 18 years of age undergoing treatment for long periods with acetylsalicylic acid, because of the potential increase of Reye syndrome associated with influenza c. All individuals who are pregnant d. All individuals of any age who are residents of nursing homes and other chronic care facilities e. Adults 65 years of age and older f. Indigenous Peoples\n19. Any contraindication to receiving oseltamivir or zanamivir including known history of negative\u002Fanaphylactic reactions. Inability to take capsules containing gelatin or sorbitol (oseltamivir) or lactose-intolerant (zanamivir)\n20. Recent (within the 6 months before Screening Day) nasal or sinus surgery or diagnosis with nasal polyps.\n21. Recent use (4 weeks of Screening Day) of intranasal steroids, antihistamines, or any substance (including legally prohibited or prescription drug) that is administered nasally.\n22. Receipt of any investigational drug or vaccine within 6 months prior to challenge. An investigational drug or vaccine is one that is still being tested in clinical trials that has not yet been authorized for use in Canada for administration by public programs.\n23. Receipt of any authorized vaccines within 2 weeks prior to being challenged.\n24. Previous moderate or severe laboratory-confirmed SARS-CoV-2\u002FCOVID-19, influenza infection, or any other respiratory virus infection (e.g., RSV) that required hospitalization.\n25. Head trauma (e.g., fracture of the cribriform plate) within 1 year of screening.\n26. Symptoms indicative of acute respiratory illness (such as fever, cough, difficulty breathing) identified during the physical examination done on Study Day -1 (check-in) or Day 1 before a participant is challenged. In the event a participant reports changes to their medical history since screening up until check-in, a history-directed respiratory panel will be administered and any positive respiratory virus including SARS-COV-2 will be exclusionary\n27. History of Bell's Palsy, Guillain-Barre, and\u002For facial paralysis.\n28. Receipt of facial cosmetic filler, or any facial neuromodulator, in the past 3 months.\n29. Self-reported sleep apnea that requires a continuous positive airway pressure (cPap) machine\n30. Receipt of blood or blood products during the six months prior to the planned date of challenge.\n31. Plans to donate blood anytime throughout the study.\n32. Any other finding that the Investigator\u002Fstudy physician considers will make the participant unsuitable for the study or unable to comply with the study requirements.","45 Years",{"count":88,"type":20},32,[90],"PHASE1","The overall objective is to establish an influenza Controlled Human Infection Model (CHIM) in Canada that can be used to assess the safety and efficacy of candidate vaccines, biologics, and therapeutics targeting influenza viruses.",[93],"Influenza (Healthy Volunteers)",[95,96,97,98,99,100],"human challenge","Controlled human infection model","Influenza","intranasal challenge","Phase 1 clinical trial","Immune response","2025-12-12",{"date":103,"type":38},"2025-12-26",{"date":105,"type":20},"2026-02-01",{"date":107,"type":20},"2028-01-31",{"name":44,"class":45},{"id":110,"slug":111,"hasResults":11,"nctId":112,"briefTitle":113,"officialTitle":114,"acronym":4,"eligibilityCriteria":115,"healthyVolunteers":16,"sex":54,"minAge":55,"maxAge":116,"enrollmentInfo":117,"targetDuration":4,"studyType":58,"phases":119,"briefSummary":120,"conditions":121,"keywords":123,"overallStatus":128,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":137},"100579682","phase-1-establishing-a-controlled-human-infection-model-of-pertactin-deficient-bordetella-pertussis-100579682","NCT06827470","Establishing a Controlled Human Infection Model of Pertactin-deficient Bordetella Pertussis","Open-label, Phase 1\u002F2, Dose-escalation Clinical Trial to Establish a Controlled Human Infection Model by Determining and Confirming the Optimal and Safe J820 Bordetella Pertussis Dose Administered Intranasally to Healthy Adults 18-50 Years of Age That Induces Mild Symptomatic Infection and Detection of B. Pertussis in Nasal Samples","Inclusion Criteria:\n\nTo be eligible for the study, each participant must satisfy ALL of the following criteria:\n\n1. Age 18-50 years, inclusive.\n2. Good general health status, as determined by history and physical examination conducted no longer than 30 days prior to the challenge.\n3. Participants who, in the opinion of the Investigator, can and will comply with the requirements of the protocol (e.g., complete Diary Cards, return for follow-up visits).\n4. Written informed consent obtained from the participant.\n5. If a cis woman and\u002For gender divergent person is at risk of becoming pregnant has practiced adequate contraception for 28 days prior to challenge and has a negative pregnancy test on the day before B. pertussis challenge and has agreed to continue adequate contraception until 60 days after inoculation.\n\nRisk of pregnancy is defined as any individual assigned female at birth or with reproductive capacity who is sexually active with individuals with sperm-producing capabilities. Individuals who have received the following are considered to not have reproductive capacity:\n\n* Documented hysterectomy\n* Documented bilateral salpingectomy\n* Documented bilateral oophorectomy\n* Documented and current bilateral tubal ligation or occlusion\n* Credible self-reported history of diagnosed infertility\n* Hormone therapy (e.g., testosterone), provided it is administered consistently and medically assessed as sufficient to reduce pregnancy such that ovulation has ceased\n* Any other condition, as determined by the Principal Investigator, that would render an individual incapable of becoming pregnant\n\nAdequate contraception is defined as a contraceptive method with a failure rate of \\\u003C1% per year when used consistently and correctly and, when applicable, in accordance with the product label. Examples include the following:\n\n* Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal, or transdermal\n* Progestogen-only hormonal contraception associated with inhibition of ovulation: oral, injectable, or implantable\n* Intra-uterine device (IUD) with or without hormonal release\n* Vasectomized partner, if this is the participant's sole partner and the partner has received a medical assessment of the surgical success\n* Credible self-reported history of abstinence for at least 28 days prior to challenge\n\nExclusion Criteria:\n\nParticipants with ANY of the following criteria at the time of screening will be excluded:\n\n1. Underlying chronic medical condition requiring ongoing follow-up and monitoring by a physician (e.g., diabetes, seizure disorder).\n2. Underlying cardiac and\u002For pulmonary disease including hypertension, angina, prior myocardial infarction, asthma, emphysema, chronic bronchitis, and pulmonary tuberculosis.\n3. Moderate or severe symptoms of health anxiety, anxiety, and mood symptoms. Self-reported current diagnosis of a major psychiatric illness, including a schizophrenia spectrum disorder, bipolar disorder, posttraumatic stress disorder, obsessive compulsive disorder, substance use, or eating disorder.\n4. QT prolongation on electrocardiogram (EKG).\n5. History of everyday smoking\u002Fvaping in the last 2 years and\u002For current smoking\u002Fvaping more than once per week.\n6. Pregnant (known before or established at the time of screening using a urine-based test) or breastfeeding.\n7. Immunocompromised (with HIV\u002FAIDS-positive or receiving immunosuppressive therapy involving steroids) or with any medical condition or medication that leads to a compromised immune system.\n8. Positive for hepatitis B or C by blood test.\n9. Vaccinated against pertussis within previous 5 years and\u002For \\>7 cumulative doses from infancy to date of screening.\n10. Reported history of laboratory-confirmed pertussis infection, including having been exposed to B. pertussis in a Controlled Human Infection Model\n11. Antibody titer to pertussis toxin \\>20 IU\u002FmL (2x the lower limit of quantification (LLOQ)).\n12. Detection of B. pertussis in nasal samples prior to challenge using culture isolation and\u002For PCR detection, or detection of other respiratory infection.\n13. Living or working with (any form of close contact) any of the at-risk\u002Fvulnerable groups who are not up to date on their vaccination, specifically children \\\u003C1 year of age, pregnant woman who have not yet received their maternal Tdap vaccine, immunocompromised individuals, adults \\>65 years of age who have not received a dose of Tdap vaccine within the past 10 years, or other at risk persons, as applicable, up to Day 57.\n\n    Note: Household members whose vaccination is not current will be offered or directed to a pertussis-containing vaccine, as recommended and funded by the Nova Scotia Department of Health and Wellness.\n14. Known allergy to macrolides including azithromycin or erythromycin, history of Clostridium difficile within last 2 months.\n15. Any contraindication to receiving azithromycin.\n16. Taking any systemic antibiotic currently or within the previous 2 weeks.\n17. Currently taking terfenadine, astemizole, theophylline, or cimetidine.\n18. Poor venous access, as defined by inability to obtain venous blood after 3 venipuncture attempts.\n19. Recent (within 6 months) nasal or sinus surgery, recent use of intranasal steroids (4 weeks), or diagnosis with nasal polyps.\n20. Receipt of any investigational drug or vaccine within 6 months prior to challenge. An investigational vaccine is defined as a vaccine that is still being tested in clinical trials or one that has not yet been authorized for use in Canada for administration by public vaccine programs.\n21. Receipt of any authorized vaccines within 2 weeks prior to challenge with B. pertussis in this study. (This is to avoid attributing any AEs from these vaccines to the B. pertussis challenge, which would skew the study results.)\n22. Previous moderate or severe respiratory infection that required hospitalization.\n23. Head trauma (e.g., fracture of the cribriform plate) within 1 year of screening.\n24. Any other finding that the Investigator considers will make the participant unsuitable for the study or unable to comply with the study requirements.\n25. Symptoms indicative of acute respiratory illness (such as fever, cough, difficulty breathing) identified during the physical examination done on Day -1 (check-in) or Study Day 1 before a participant is challenged.\n26. History of Bell's Palsy and\u002For facial paralysis.\n27. Receipt of facial cosmetic filler in the past 3 months.","50 Years",{"count":118,"type":20},60,[90],"The overall goal of this study is to establish a PRN-deficient pertussis Controlled Human Infection Model (CHIM) that represents currently circulating isolates, in the context of a North American exposure (vaccination and infection) pedigree.",[122],"Pertussis (Whooping Cough)",[124,125,126,96,127,99,100],"Bordetella pertussis","Pertussis","Whooping cough","Human challenge","RECRUITING","2025-11-27",{"date":131,"type":38},"2025-12-04",{"date":133,"type":38},"2025-11-24",{"date":135,"type":20},"2027-04-30",{"name":44,"class":45},1,{"id":139,"slug":140,"hasResults":11,"nctId":141,"briefTitle":142,"officialTitle":143,"acronym":4,"eligibilityCriteria":144,"healthyVolunteers":11,"sex":54,"minAge":55,"maxAge":145,"enrollmentInfo":146,"targetDuration":4,"studyType":58,"phases":148,"briefSummary":149,"conditions":150,"keywords":154,"overallStatus":128,"whyStopped":4,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":160,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":166,"locationsCount":137},"100563684","the-impact-of-coach-guided-risk-communication-on-the-risk-of-major-depression-100563684","NCT06619366","The Impact of Coach-guided Risk Communication on the Risk of Major Depression","The Impact of Coach-guided Risk Communication on the Risk of Major Depression: A Randomized Controlled Trial","Inclusion Criteria:\n\n* no MDE at baseline, or full remission for 2 months for those who had a past MDE (see below the question).\n* Aged 18 and 65 years.\n* At high risk of MDE based on the depression risk calculators (predicted risk of 6.5%+ for males and 11.2%+ for females), which represent the top two deciles of male and female populations in Canada.\n* Agreement to be contacted for follow-up assessments, and\n* no language barriers to English or French\n\nExclusion Criteria:\n\nindividuals who\n\n* cannot provide informed consent,\n* do not agree to be followed,\n* cannot communicate in English and French, or\n* report suicide behaviors (score \\>0 on item 9 of the Patient Health Questionnaire (PHQ-9)).","65 Years",{"count":147,"type":20},1000,[60],"Depression is a highly prevalent and disabling mental health problem. One way of preventing depression is to stop it before it happens through effective self-management. Working with potential users, a coach-guided, personalized depression risk communication tool (PDRC) was developed for sharing information about individualized depression risk, risk profile (risk factors present), potential risk reduction and evidence-based self-help strategies. It is anticipate that the PDRC will greatly motivate users to actively engage in self-help and help seeking, leading to a reduced risk of depression. The proposed study will recruit 500 male and 500 female adults who are at high risk of having depression across Canada, and randomly allocate them into the intervention and control groups. Participants will be followed for 12 months. The data of the trial will allow us to answer the questions: (1) Can the coach-guided PDRC reduce the risk of depression? (2) Does the intervention motivate people to actively engage in evidence-based self-help and help-seeking behaviors? (3) For whom the intervention works best? and (4) what are the costs and potential savings associated with the intervention? If successful, this project will offer a novel and effective tool for early prevention of major depression in the Canadian general population, help us understand how it works and the cost-effectiveness of implementing such a tool in the community from the economic perspective.",[151,152,153],"Major Depressive Episode","Risk Reduction","Self Efficacy",[155,156,157,158],"major depressive episode","risk communication","coach-guided","self-help","2025-08-26",{"date":161,"type":38},"2025-09-02",{"date":163,"type":38},"2025-02-10",{"date":165,"type":20},"2029-10",{"name":44,"class":45},{"id":168,"slug":169,"hasResults":11,"nctId":170,"briefTitle":171,"officialTitle":172,"acronym":173,"eligibilityCriteria":174,"healthyVolunteers":11,"sex":17,"minAge":175,"maxAge":176,"enrollmentInfo":177,"targetDuration":4,"studyType":58,"phases":179,"briefSummary":180,"conditions":181,"keywords":188,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":193,"lastUpdatePostDateStruct":194,"startDateStruct":196,"completionDateStruct":198,"leadSponsor":200,"locationsCount":4},"100586056","an-app-to-reduce-social-medias-impact-on-body-image-and-eating-disorders-100586056","NCT06910410","An App to Reduce Social Media's Impact on Body Image and Eating Disorders","An App to Disrupt the Link Between Social Media and Negative Body Image And Disordered Eating: A Pilot Study Of Feasibility, Acceptability, and Preliminary Efficacy","BodyScreen","Inclusion Criteria:\n\n* Women aged 15-29 years old\n* Ability to provide informed consent\n* Access to a smartphone (iOS or Android)\n* A score greater than 47 on the Eating Disorder Risk Composite (EDRC) from the Eating Disorder Inventory-3 (EDI-3) is considered to be at high risk for an eating disorder and therefore makes a participant eligible for this study.\n* Use of social media (SM) for appearance-related reasons.\n\nExclusion Criteria:\n\n* A concurrent treatment for self-esteem, perfectionism, body image, or disordered eating, as it may interfere with the intervention under investigation and will make it difficult to attribute any symptom changes to either treatment.","15 Years","29 Years",{"count":178,"type":20},50,[60],"Social media (SM) is a key communication tool, particularly for young women aged 15-29. While SM fosters social connections, it is also linked to negative effects on mental health, including poor body image, low self-esteem, and maladaptive perfectionism. These issues arise due to social comparison with idealized images, especially on platforms like Instagram, which can contribute to disordered eating behaviours. Research suggests that reducing SM use can improve mental well-being, body image, and eating disorder symptoms. However, current interventions have not simultaneously addressed both reducing SM exposure and strengthening protective psychological factors. To address this gap, the proposed study aims to pilot BodyScreen, an intervention app designed to limit SM exposure while enhancing self-esteem and reducing perfectionism in young women at high risk for eating disorders. The study hypothesizes that BodyScreen will be feasible, acceptable, and effective in improving body image, self-esteem, and SM use, with sustained benefits at a 3-month follow-up. The intervention includes a virtual face-to-face session, mid-intervention email support, and a four-week app-based program using Ecological Momentary Interventions (EMIs). Participants will receive reminders to complete exercises designed to improve self-perception and reduce the negative effects of SM. Additionally, Ecological Momentary Assessment (EMA) will track real-time self-esteem, perfectionism, and body image, while mobile sensing will monitor SM use to tailor interactive exercises accordingly. By integrating exposure reduction with psychological strengthening, BodyScreen aims to provide a novel, evidence-based approach to mitigating the harmful effects of SM on young women's mental health.",[182,183,184,185,186,187],"Anorexia Nervosa","Bulimia","Body Dissatisfaction","Self-esteem","Perfectionism","Disordered Eating Behaviors",[189,190,191,192],"self-esteem","perfectionism","disordered eating","youth mental health","2025-04-02",{"date":195,"type":38},"2025-04-04",{"date":197,"type":20},"2025-07",{"date":199,"type":20},"2027-07",{"name":44,"class":45},{"id":202,"slug":203,"hasResults":11,"nctId":204,"briefTitle":205,"officialTitle":205,"acronym":206,"eligibilityCriteria":207,"healthyVolunteers":11,"sex":54,"minAge":55,"maxAge":4,"enrollmentInfo":208,"targetDuration":4,"studyType":58,"phases":210,"briefSummary":211,"conditions":212,"keywords":214,"overallStatus":128,"whyStopped":4,"lastUpdateSubmitDate":163,"lastUpdatePostDateStruct":220,"startDateStruct":222,"completionDateStruct":224,"leadSponsor":226,"locationsCount":227},"100575822","cognitive-behavioural-couple-therapy-for-sexual-interestarousal-disorder-100575822","NCT06777277","Cognitive-Behavioural Couple Therapy for Sexual Interest\u002FArousal Disorder","CBCT for SIAD","Inclusion Criteria:\n\n* One member of the couple must identify as a cisgender woman, a trans woman, or a gender diverse person assigned female at birth;\n* One member of the couple must meet diagnostic criteria for SIAD;\n* Both partners must be fluent in English or French;\n* Both partners must be in a committed, cohabiting relationship for at least one year (with a partner of any gender\u002Fsex).\n\nExclusion Criteria:\n\n* Pregnancy, breastfeeding or one year postpartum;\n* No prior sexual experience;\n* Severe relational distress or conflict as determined by baseline measures and interview;\n* Are currently undergoing treatment for SIAD, or are in couple or sex therapy.",{"count":209,"type":20},170,[60],"Sexual health is a fundamental aspect of quality of life; a satisfying sexual relationship is linked to better physical, psychological, and relationship health and well-being. In fact, people who maintain a satisfying, active sex life over time live longer than those who report lower sexual frequency and satisfaction. Yet problems with sexual function are extremely common, especially for women: chronic difficulties with sexual desire and\u002For arousal that are personally upsetting-Sexual Interest\u002FArousal Disorder (SIAD)-affects 7% to 23% of the general population. SIAD is linked to more healthcare costs, depressive symptoms and anxiety, and lower relationship satisfaction. Experts suggest that relationship factors play a critical role in SIAD and couple-based sex therapy is a common approach used by clinicians. However, there are no treatment options available for couples that have been tested in research to confirm that they work. The goal of this three-centre randomized clinical trial is to evaluate the efficacy of a novel 16-session cognitive-behavioural couple therapy (CBCT), offered online to increase accessibility, for an inclusive sample of women with SIAD compared to a waitlist control group. The investigators expect that, compared to a waitlist control group, CBCT will lead to greater improvements in SIAD symptoms (e.g., higher sexual desire\u002Farousal, lower sexual distress) and better sexual, relational, and psychological adjustment for both partners at post-treatment and 6-months later. Given that less than a third of those affected by SIAD access treatment, this study addresses the urgent need for an accessible couple-based treatment for the most common sexual dysfunction. Results will be used by clinicians to provide couples with a scientifically based, accessible treatment option, that will improve their sexual, relationship, and psychological health.",[213],"Sexual Interest\u002FArousal Disorder",[215,216,217,218,219],"cognitive-behavioral couple therapy","Emotion regulation","Sexual dysfunction","Female sexual interest\u002Farousal disorder","DSM-5",{"date":221,"type":38},"2025-02-12",{"date":223,"type":38},"2025-01-07",{"date":225,"type":20},"2028-12-01",{"name":44,"class":45},3,{"id":229,"slug":230,"hasResults":11,"nctId":231,"briefTitle":232,"officialTitle":233,"acronym":4,"eligibilityCriteria":234,"healthyVolunteers":11,"sex":54,"minAge":55,"maxAge":4,"enrollmentInfo":235,"targetDuration":4,"studyType":58,"phases":237,"briefSummary":238,"conditions":239,"keywords":243,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":252,"lastUpdatePostDateStruct":253,"startDateStruct":255,"completionDateStruct":257,"leadSponsor":258,"locationsCount":4},"100532374","the-feasibility-of-the-opiventure-program-for-clients-undergoing-opioid-agonist-therapy-100532374","NCT06211972","The Feasibility of the OpiVenture Program for Clients Undergoing Opioid Agonist Therapy","Personality-Targeted Interventions for Addressing Polysubstance Use Among Opioid-Addicted Clients Undergoing Opioid Agonist Therapy: A Feasibility Study","Inclusion Criteria:\n\nCurrently enrolled in Opioid Agonist Therapy at one of the 4 partner clinics in Quebec and Atlantic Canada for 30 days\n\n≥18 years of age Score at least one standard deviation (SD) above the population-specific norm on 1 of 4 personality traits on the Substance Use Risk Profile Scale (SURPS ) Ability to understand spoken English or French Ability to provide informed consent\n\nExclusion Criteria:\n\nThose who are unable to provide informed consent and indicate severe cognitive impairment -measured by the Mini-Mental State Examination (MMSE), will be excluded.",{"count":236,"type":20},96,[60],"The opioid crisis continues its devastating impact on Canada, with over 13,900 deaths recorded between 2016 and 2019. Dangerous prescription opioid usage persists, affecting 12.3% of Canadians in 2018. The crisis has escalated, particularly during the COVID-19 pandemic, resulting in increased mortality rates. While opioid agonist therapy (OAT) is a common treatment, it falls short in addressing concurrent polysubstance use, a prevalent issue in OAT clients. Recognizing the limitations of OAT alone, there is a growing recommendation to supplement it with psychosocial interventions.\n\nThe PreVenture program, known for its efficacy in reducing substance use, has been adapted for OAT clients, termed \"OpiVenture.\" This study aims to comprehensively assess OpiVenture's feasibility and limited efficacy within an OAT setting. Utilizing a mixed-methods approach, the study design integrates qualitative and quantitative data collection methods to thoroughly evaluate the program's feasibility and preliminary effectiveness. The focus extends beyond immediate outcomes, encompassing the preparation for future randomized controlled trials, including considerations for sample size calculation and recruitment effectiveness. This research addresses the urgent need for more comprehensive interventions to mitigate opioid use disorder (OUD) and associated morbidity, offering a potential solution to improve OAT retention and reduce mortality rates.",[240,241,242],"Opioid Use Disorder","Polysubstance Addiction","Substance Use",[244,245,246,247,248,249,250,251],"Anxiety sensitivity","Hopelessness","Sensation-seeking","Impulsivity","Personality","Psychosocial Interventions","Feasibility","Opioid Agonist Therapy","2024-07-26",{"date":254,"type":38},"2024-07-30",{"date":256,"type":20},"2024-10-15",{"date":105,"type":20},{"name":44,"class":45},""]