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Participants will be assigned by chance (like the flip of a coin) to receive one of three possible vaginal estrogen treatments - cream, tablets, or drug-eluting ring.
* The main study tests and procedures include an initial visit in which the researchers will collect baseline information about participants and have participants complete a series of questionnaires.
* There will then be 3 and 6 month follow-ups in which the researchers will have participants complete additional questionnaires and the researchers also assess whether participants are using the vaginal estrogen treatment that you were prescribed.
If a participant is part of the microbiome cohort, they will also be asked to do the following:
* a baseline visit in which urinary and vaginal specimens are collected to assess their baseline microbiome. The vaginal specimen collection will involve a q-tip swab inside the vagina; it is similar to a pap smear.
* Finally, participants will have an imaging modality performed on their vagina called optical coherence tomography, which allows the researchers to assess the thickness of the vaginal walls and the blood vessel density. This imaging modality involves the insertion of a thin probe into the vagina to obtain the images of the vaginal wall.
* These tests will then be repeated at 6 months to assess if vaginal estrogen treatment causes changes to the vagina. conditions: Recurrent Urinary Tract Infection conditions: Hypoestrogenism studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 111 type: ESTIMATED name: Estring Vaginal Product name: Vagifem name: Estrace 0.01% Vaginal Cream measure: Adherence to vaginal estrogen treatment measure: UTI rates measure: validated patient questionnaire - Urinary Distress Inventory Short Form (UDI-6) measure: validated patient questionnaires - UTI Symptoms Assessment Questionnaire (UTISA) measure: validated patient questionnaires - Treatment Satisfaction with Medications Questionnaire (SATMED-Q) measure: validated patient questionnaires - Patient Global Impression of Improvement Questionnaire (PGI-I) measure: validated patient questionnaires - Medication Adherence Report Scale (MARS-5) measure: optical coherence tomography measurements for nested OCT cohort - vaginal epithelial thickness measure: optical coherence tomography measurements for nested OCT cohort - blood vessel density measure: Vaginal health index for nested microbiome cohort measure: Vaginal maturation index for nested microbiome cohort measure: Urologic microbiome results for nested microbiome cohort measure: Vaginal microbiome results for nested microbiome cohort sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of California Irvine Medical Center status: RECRUITING city: Orange state: California zip: 92868 country: United States name: CHARLOTTE TER HAAR role: CONTACT email: terhaarc@hs.uci.edu lat: 33.78779 lon: -117.85311 hasResults: False
<\|newrecord\|> nctId: NCT06353256 id: 300012607 id: UL1TR003096 type: NIH link: https://reporter.nih.gov/quickSearch/UL1TR003096 id: 24POST1198805 type: OTHER_GRANT domain: American Heart Association briefTitle: A Community Health Worker Intervention to Address Preeclampsia acronym: AW2H overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-04-30 date: 2025-04-30 date: 2024-04-09 date: 2024-04-09 name: University of Alabama at Birmingham class: OTHER name: American Heart Association name: National Center for Advancing Translational Sciences (NCATS) briefSummary: United States maternal mortality and preterm birth rates are among the highest among high-income countries due in part to a combination of racial, regional and socioeconomic disparities in access to care and overall health. The research proposed focuses on adapting and expanding a perinatal community health worker intervention for Black postpartum patients with preeclampsia (PE). Investigators will partner with a community-based organization that trains and deploys community health workers. Investigators will test an intervention for urban and rural Black postpartum patients with PE to 1) enhance blood pressure control postpartum and 2) promote long-term cardiovascular disease prevention for this underserved population. This pilot study will determine if randomizing and implementing a community health worker intervention tailored to pregnant people experiencing preeclampsia is feasible and found to be acceptable by participants. conditions: Preeclampsia Postpartum studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: usual postpartum care measure: Acceptability sex: FEMALE minimumAge: 16 Years maximumAge: 56 Years stdAges: CHILD stdAges: ADULT hasResults: False
<\|newrecord\|> nctId: NCT06353243 id: STUDY00022901 briefTitle: Bilateral Infant Stimulation Study acronym: BLISS overallStatus: RECRUITING date: 2024-02-26 date: 2024-08 date: 2024-08 date: 2024-04-09 date: 2024-04-09 name: Oregon Health and Science University class: OTHER briefSummary: This study will investigate stress that parents of children admitted to the neonatal intensive care unit (NICU) experience. Investigation of a novel intervention of using bilateral alternating stimulation to reduce parental stress and anxiety and increase bonding/attachment in NICU. Evaluate parental stress and feelings of bonding using surveys before and after the intervention. Intervention will be done at neonate's bedside while admitted to the NICU. Vital sign data will be collected as a marker of parent and neonate's stress response during the intervention. conditions: Parent-Child Relations conditions: Preterm Birth conditions: Stress Reaction conditions: Hospitalism in Children studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 40 type: ESTIMATED name: Bilateral alternating stimulation measure: Parental anxiety measure: Physiologic stress response measure: Parental distress sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Oregon Health and Science University Neonatal Intensive Care Unit status: RECRUITING city: Portland state: Oregon zip: 97219 country: United States name: Emily Garavatti, MD role: CONTACT phone: 503-494-2634 email: garavatt@ohsu.edu lat: 45.52345 lon: -122.67621 hasResults: False
<\|newrecord\|> nctId: NCT06353230 id: 0001 briefTitle: Comparison of Sclerotherapy Agents Used for Rectal Prolapse Treatment in Children acronym: Prolapse overallStatus: COMPLETED date: 2019-10-15 date: 2020-10-14 date: 2021-04-13 date: 2024-04-09 date: 2024-04-15 name: King Edward Medical University class: OTHER briefSummary: Introduction Patients with rectal prolapse are treated with injection sclerotherapy, which is the most often used first-line surgical technique. Injection sclerotherapy has a success rate of 90-100% in youngsters, according to certain studies. Objective To compare the outcome of injection sclerotherapy using 5% Phenol in almond oil, 15% hypertonic saline and 50% dextrose water in the treatment of rectal prolapse in children. conditions: Rectal Prolapse studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Comparison of 5% phenol in almond oil, 15% hypertonic saline and 50% dextrose water for sclerotherapy treatment of rectal prolapse in children. primaryPurpose: TREATMENT masking: NONE maskingDescription: Randomly allocated groupA,B or C by computer generated lottery method.and participants ,care provider and outcome assessor were kept blind by removing the drug name from injection vial count: 93 type: ACTUAL name: injection 5% phenol in almond oil name: injection 15% hypertonic saline name: injection 50% dextrose water measure: Recurrence measure: fecal incontinence sex: ALL minimumAge: 3 Years maximumAge: 13 Years stdAges: CHILD facility: department of pediatric surgery King Edward Medical University city: Lahore state: Punjab zip: 54000 country: Pakistan lat: 31.558 lon: 74.35071 hasResults: False
<\|newrecord\|> nctId: NCT06353217 id: IRB00419034 id: K23DK128572 type: NIH link: https://reporter.nih.gov/quickSearch/K23DK128572 briefTitle: Study of a Primary Care Hypoglycemia Prevention Program overallStatus: RECRUITING date: 2024-04-14 date: 2026-04-14 date: 2026-04-14 date: 2024-04-09 date: 2024-04-10 name: Johns Hopkins University class: OTHER name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) briefSummary: This is a single site, pre-post pilot study. The objective is to evaluate the acceptability and feasibility of a primary care hypoglycemia prevention program for patients taking hypoglycemia-causing medications. The study will also evaluate relevant process outcomes and clinical outcomes for refining the intervention and planning for a larger efficacy trial. conditions: Diabetes Mellitus conditions: Hypoglycemia studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Pre/post pilot study primaryPurpose: PREVENTION masking: NONE count: 35 type: ESTIMATED name: Patient Group (Hypoglycemia Prevention Program) name: Primary Care Physician Group name: Clinic Staff Group measure: Overall acceptability to patients measure: Overall acceptability to primary care providers measure: Overall acceptability to clinic staff measure: Intervention coherence (patients) measure: Opportunity costs (patients) measure: Ethicality (patients) measure: Affective attitude (patients) measure: Burden (patients) measure: Self-efficacy (patients) measure: Perceived effectiveness (primary care providers) measure: Intervention coherence (primary care providers) measure: Opportunity costs (primary care providers) measure: Affective attitude (primary care providers) measure: Burden (primary care providers) measure: Self-efficacy (primary care providers) measure: Burden (clinic staff) measure: Opportunity costs (clinic staff) measure: Recruitment rate measure: Retention rate for second clinic visit measure: Continuous glucose monitoring (CGM) completion measure: Continuous glucose monitoring (CGM) wear time measure: Time needed to complete patient hypoglycemia profile measure: Duration of clinical visit measure: Patient completion of hypoglycemia assessment measure: Primary care provider use of provider hypoglycemia toolkit measure: Patient hypoglycemia burden on continuous glucose monitoring (CGM) measure: Patient time below range on continuous glucose monitoring (CGM) measure: Patient time above range on continuous glucose monitoring (CGM) measure: Patient mean glucose on continuous glucose monitoring (CGM) measure: Patient satisfaction with care measure: Patient activation measure: Patient self-reported hypoglycemic events measure: Changes to hypoglycemia-causing medications measure: Glucagon prescription measure: Continuous glucose monitoring (CGM) prescription measure: Change in Frequency of Referrals to Diabetes Self Management Training (DSMT) measure: Frequency of hypoglycemia history discussions measure: Frequency of Hypoglycemia anticipatory guidance discussions measure: Frequency of Medication adherence discussions sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Johns Hopkins University School of Medicine status: RECRUITING city: Baltimore state: Maryland zip: 21287 country: United States name: Scott J Pilla, MD, MHS role: CONTACT phone: 908-768-0002 email: spilla1@jhmi.edu lat: 39.29038 lon: -76.61219 hasResults: False
<\|newrecord\|> nctId: NCT06353204 id: 3325 briefTitle: Effectiveness of the Justice Diversion Halt-intervention overallStatus: RECRUITING date: 2024-02-01 date: 2027-07 date: 2027-07 date: 2024-04-09 date: 2024-04-09 name: Wetenschappelijk Onderzoek en Datacentrum class: OTHER_GOV name: Utrecht University name: Leiden University briefSummary: In the current study the effectiveness of the Dutch diversion measure Halt is investigated using a randomized controlled trial. Because of the thorough scientific substantiation of the intervention theory, it is hypothesized that receiving the Halt-intervention will lead to less recidivism in comparison to receiving no intervention. conditions: Criminal Recidivism conditions: Delinquency conditions: Antisocial Behavior studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A comparison between two groups will be made. One half of the participants will be randomly assigned to a group that receives the Halt-intervention, while the other group receives no Halt-intervention. primaryPurpose: TREATMENT masking: NONE count: 1300 type: ESTIMATED name: Halt-intervention measure: Criminal Recidivism based on self-report measure: Criminal Recidivism based on official police records measure: Criminal Recidivism based on official judiciary records measure: Truancy based on self-report measure: Conventional beliefs measure: Minimizing/mislabeling measure: Social skills measure: Taking responsibility for the consequences of behavior measure: Correct wrongdoing measure: Support from social network measure: Experienced legitimacy measure: Experienced treatment measure: Receiving adequate information measure: The right to be informed measure: Experienced voluntariness measure: Access to legal assistance measure: Knowledge of not obtaining a criminal record measure: Experienced stigmatisation measure: Experienced re-integration measure: Mental health problems during the last six months measure: Experienced problems measure: Delinquent friends measure: Parental involvement measure: Demographical characteristics measure: Halt-intervention program integrity measure: Characteristics Halt-employee measure: Perceived relationship with Halt-employee measure: Educational attainment measure: Type of criminal offense measure: Characteristics of referral to Halt-intervention measure: Types of modules used during the Halt-intervention measure: Parts of the Halt-intervention carries out as group or solo intervention sex: ALL minimumAge: 12 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: WODC status: RECRUITING city: The Hague state: Zuid-Holland zip: 2500EH country: Netherlands name: Benthe J van Delft, MSc role: CONTACT email: b.j.van.delft@wodc.nl lat: 52.07667 lon: 4.29861 hasResults: False
<\|newrecord\|> nctId: NCT06353191 id: 19-002566 id: NCI-2024-00943 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: 19-002566 type: OTHER domain: Mayo Clinic in Florida id: P30CA015083 type: NIH link: https://reporter.nih.gov/quickSearch/P30CA015083 id: R01HL169268 type: NIH link: https://reporter.nih.gov/quickSearch/R01HL169268 id: R56HL160643 type: NIH link: https://reporter.nih.gov/quickSearch/R56HL160643 briefTitle: Biomarkers to Predict Cancer Therapy-related Cardiotoxicity overallStatus: RECRUITING date: 2019-05-03 date: 2026-06-01 date: 2026-06-01 date: 2024-04-08 date: 2024-04-08 name: Mayo Clinic class: OTHER name: National Cancer Institute (NCI) name: National Heart, Lung, and Blood Institute (NHLBI) briefSummary: This study evaluates why some cancer patients but not others experience changes in heart function following treatment with chemotherapy. conditions: Hematopoietic and Lymphatic System Neoplasm conditions: Malignant Solid Neoplasm studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1000 type: ESTIMATED name: Non-Interventional Study measure: Collection of biospecimens from patients who developed cardiac toxicity (CRCT) or who are at high risk for developing CRCT sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mayo Clinic in Arizona status: RECRUITING city: Scottsdale state: Arizona zip: 85259 country: United States name: Clinical Trials Referral Office role: CONTACT phone: 855-776-0015 email: mayocliniccancerstudies@mayo.edu name: Myrah Manuel role: CONTACT phone: 480-574-3157 email: Manuel.Myrah@mayo.edu name: Lida A. Mina, MD role: PRINCIPAL_INVESTIGATOR lat: 33.50921 lon: -111.89903 facility: Mayo Clinic in Florida status: RECRUITING city: Jacksonville state: Florida zip: 32224-9980 country: United States name: Clinical Trials Referral Office role: CONTACT phone: 855-776-0015 email: mayocliniccancerstudies@mayo.edu name: Pamela Williamson role: CONTACT phone: 904-953-4694 email: Williamson.Pamela@mayo.edu name: Nadine Norton, Ph.D. role: PRINCIPAL_INVESTIGATOR lat: 30.33218 lon: -81.65565 facility: Mayo Clinic in Rochester status: SUSPENDED city: Rochester state: Minnesota zip: 55905 country: United States lat: 44.02163 lon: -92.4699 hasResults: False
<\|newrecord\|> nctId: NCT06353178 id: 20240314 briefTitle: Building Empowerment and Coping Outcomes for caNcer Patients, Survivors and Their Caregivers acronym: BEACON overallStatus: RECRUITING date: 2024-04-08 date: 2025-02-01 date: 2025-04-01 date: 2024-04-08 date: 2024-04-08 name: Color Health, Inc. class: INDUSTRY briefSummary: Cancer has a psychological, emotional and social impact beyond a patient's physical health. This study examines three new online peer mental-wellness support program for cancer patients, survivors or their caregivers. Each program teaches evidence-based skills, in the context of that groups lived experience, to manage the emotional impact of cancer. This study examines the impact of that program. conditions: Cancer conditions: Caregiving Stress conditions: Caregiver Burnout conditions: Survivorship studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants will be randomized to waitlist or intervention group. Those in intervention group will receive the peer program; those on the waitlist will receive it after being on the waitlist for 3 months. primaryPurpose: SUPPORTIVE_CARE masking: NONE maskingDescription: Participants will be notified of a waitlist assignment upon enrolling. Those on the waitlist will receive the intervention after 3 months. count: 120 type: ESTIMATED name: Cancer Connect Program measure: Quality of Life sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Color Health status: RECRUITING city: Burlingame state: California zip: 94010 country: United States lat: 37.5841 lon: -122.36608 hasResults: False
<\|newrecord\|> nctId: NCT06353165 id: CRO-2022-12-BAC-SNF-THA-YPZ briefTitle: Anti-bacterial Clinical Study on Teeth, Tongue, Cheek, Gum, and Saliva overallStatus: COMPLETED date: 2023-03-08 date: 2023-04-12 date: 2023-04-12 date: 2024-04-08 date: 2024-04-15 name: Colgate Palmolive class: INDUSTRY briefSummary: This 4-week clinical study was designed to examine the antibacterial efficacy of brushing with a 0.454% stannous fluoride toothpaste with potassium nitrate and pyrophosphate compared to a toothpaste containing 0.76% MFP (marketed as Colgate Cavity Protection Toothpaste) in different regions of the mouth (dental plaque, tongue, cheek, gum surface and in saliva) 12 hours post-brushing (overnight) after 2 and 4 weeks of product use. conditions: Plaque, Dental studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: blinded primaryPurpose: PREVENTION masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 100 type: ACTUAL name: Stannous fluoride toothpaste name: Colgate Dental Cream measure: Whole mouth scores of dental plaque measure: Measurement of total bacterial counts on tongue measure: Measurement of total bacterial counts on cheek measure: Measurement of gingivitis measure: Measurement of total bacterial counts in saliva sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: M U International Oral Science Research, Ltd. city: Bangkok state: Krung Thep Maha Nakhon zip: 10250 country: Thailand lat: 13.75398 lon: 100.50144 hasResults: False
<\|newrecord\|> nctId: NCT06353152 id: GC506-507 briefTitle: Claudin 18.2-Targeted Chimeric Antigen Receptor T-cells for Gastric/Gastroesophageal Junction Adenocarcinoma overallStatus: RECRUITING date: 2023-11-17 date: 2025-11-16 date: 2025-11-16 date: 2024-04-08 date: 2024-04-08 name: Peking University class: OTHER name: Gracell Biopharmaceuticals, Inc. briefSummary: A single-arm, open-label early-stage exploratory clinical study to evaluate the safety, tolerability and efficacy of Claudin 18.2-Targeted Chimeric Antigen Receptor T-cells in subjects with gastric/gastroesophageal junction adenocarcinoma. conditions: Gastric Adenocarcinoma conditions: Gastroesophageal Junction Adenocarcinoma studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 12 type: ESTIMATED name: Claudin18.2-Targeted Chimeric Antigen Receptor T Cell Injection measure: Occurrence of Dose limiting toxicity. measure: Incidence of treatment-emergent AEs, AESIs, and SAEs. measure: Disease control rate (DCR) measure: Objective response rate (ORR) measure: Duration of disease control (DDC) measure: Duration of response (DOR) measure: Progression-free survival (PFS) measure: Overall survival (OS) measure: Proliferation and persistence of Claudin18.2-Targeted Chimeric Antigen Receptor T Cell measure: Incidence of anti-CAR-T cell antibody in peripheral blood after infusion. sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Beijing Cancer Hospital status: RECRUITING city: Beijing state: Beijing zip: 100142 country: China name: Shen Lin, Professor role: CONTACT phone: 010-88196561 email: doctorshenlin@sina.cn name: Shen Lin, professor role: PRINCIPAL_INVESTIGATOR lat: 39.9075 lon: 116.39723 hasResults: False
<\|newrecord\|> nctId: NCT06353139 id: 90591 briefTitle: The Efficacy of Modified Olfactory Training for Patients With Olfactory Dysfunction overallStatus: RECRUITING date: 2023-07-01 date: 2024-12-31 date: 2024-12-31 date: 2024-04-08 date: 2024-04-08 name: Peking University Third Hospital class: OTHER briefSummary: The goal of this clinical trial is to validate the effectiveness of the modified olfactory training device, the main questions it aims to answer are:
Is it possible that the device can treat olfactory disorders in adults? Compared to the conventional device, how efficient is the modified olfactory training device for treating patients with olfactory disfunction? conditions: Olfactory Impairment studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 72 type: ESTIMATED name: Modified olfactory training device measure: Clinically significant olfactory improvement sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Dawei Wu status: RECRUITING city: Beijing state: Beijing zip: 100191 country: China name: Dawei Wu, MD, PhD role: CONTACT phone: 13522503401 email: davidwuorl@163.com role: CONTACT phoneExt: Wu email: davidwuorl@163.com name: Dawei Wu, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 39.9075 lon: 116.39723 hasResults: False
<\|newrecord\|> nctId: NCT06353126 id: DTACESALT briefTitle: DEB-TACE Prior to Liver Transplantation in the Treatment of HCC overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-07-01 date: 2027-07-01 date: 2024-04-08 date: 2024-04-08 name: RenJi Hospital class: OTHER name: Boston Scientific Corporation briefSummary: The goal of the study is to explore whether the usage of DEB-TACE (Drug-Eluting Bead Transarterial Chemoembolization) prior to SALT (Sequential Adult Left Lateral Liver Transplantation) can prolong the recurrence-free survival in patients with hepatocellular carcinoma (HCC). It is a single-center, exploratory study. The patients scheduled for SALT receive DEB-TACE 2 weeks prior to the surgery.
The primary outcome: Recurrence-free survival (RFS) The secondary outcome:1) Overall survival (OS)；2) Pathological response rate (Pathological Response); 3) Proportion of patients completing SALT; 4) Adverse events related to DEB-TACE. conditions: Liver Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: DEB-TACE measure: Recurrence-free survival (RFS) measure: Overall survival (OS) measure: Pathological response rate (Pathological Response) measure: Proportion of patients completing SALT measure: Adverse events related to DEB-TACE sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06353113 id: HS-2023-0254 briefTitle: Feasibility of a Prenatal Yoga Mobile App in African American Pregnant Women overallStatus: RECRUITING date: 2024-04 date: 2024-07 date: 2024-09 date: 2024-04-08 date: 2024-04-08 name: San Diego State University class: OTHER briefSummary: The goal of this research is to test if a prenatal yoga app can improve well-being in African American/Black (AA) pregnant women. The main questions it aims to answer are:
1. Is the Down Dog prenatal yoga app feasible for AA pregnant women?
2. How does mental and physical health change after using the Down Dog app for 12-weeks?
3. What cultural adaptations to the Down Dog app are needed?
The study lasts for 12 weeks and participants are asked to:
* do prenatal yoga with the app for at least 20 min/day, three days/week, from home
* wear a Garmin Vivosmart 5 watch daily
* complete four online surveys
* complete an optional virtual interview
This project aims to advance public health by contributing to a broader understanding of how prenatal yoga can support the health and well-being of AA pregnant women and promote optimal maternal and child health outcomes. conditions: Pregnancy Related conditions: Mental Health Issue conditions: Discrimination, Racial conditions: Stress conditions: Depression studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 50 type: ESTIMATED name: Down Dog Prenatal Yoga App measure: Acceptability of the intervention measure: Demand of the intervention measure: Retention measure: Ease of recruitment measure: Discrimination measure: Perceived stress measure: Perinatal Depression measure: Self-awareness measure: Mindfulness measure: Subjective physical activity measure: Objective physical activity (steps) measure: Objective physical activity (intensity) measure: Cardiac health (heart rate) measure: Cardiac health (heart rate variability) measure: Cultural adaptations measure: Birth outcomes (gestational age) measure: Birth outcomes (type of delivery) measure: Birth outcomes (intervention used for delivery) measure: Birth outcomes (birth weight) measure: Birth outcomes (maternal weight) measure: Birth outcomes (pregnancy-related disorders) sex: FEMALE minimumAge: 18 Years maximumAge: 46 Years stdAges: ADULT facility: San Diego State University status: RECRUITING city: San Diego state: California zip: 92182 country: United States name: Jeni Green, PhD role: CONTACT lat: 32.71533 lon: -117.15726 hasResults: False
<\|newrecord\|> nctId: NCT06353100 id: 230602006 briefTitle: Chronic Pain in the General Population of Chile acronym: RDC overallStatus: ACTIVE_NOT_RECRUITING date: 2023-01-01 date: 2024-12-30 date: 2024-12-30 date: 2024-04-08 date: 2024-04-08 name: Pontificia Universidad Catolica de Chile class: OTHER name: Chilean Safety Association (ACHS) briefSummary: The present study seeks to follow up the cohort of adults representative of Chile's urban population whose levels of chronic pain were evaluated in March 2023 (baseline) as part of the Mental Health Thermometer (MHT) study. The study consists of a 12 month follow-up telephone interview to assess parameters of chronic pain (CP) and subtypes, mental and physical health, lifestyle and adversity and work characteristics.
The study objectives are as follows:
1. Estimate the prevalence of CP and subtypes in the general population
2. Explore the association between mental health indicators, perceived work stress and presence of CP in the population.
3. Investigate the impact of CP (functional, occupational and social) among the subset of participants reporting CP
4. Describe the use of management strategies in those who suffer from CP. conditions: Chronic Pain conditions: Migraine Disability conditions: Neuropathic Pain conditions: Fibromyalgia conditions: Depression, Anxiety conditions: Self Harm conditions: Insomnia conditions: Loneliness studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 2365 type: ACTUAL measure: Chronic pain (past 3 months) measure: Depression (2 weeks) measure: Anxiety (2 weeks) measure: Migraine Disability measure: Neuropathic Pain measure: Fibromyalgia measure: Self harm (2 weeks) measure: Insomnia (2 weeks) measure: Loneliness sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Pontificia Universidad Catolica de Chile city: Santiago state: RM zip: 7550139 country: Chile lat: -33.45694 lon: -70.64827 hasResults: False
<\|newrecord\|> nctId: NCT06353087 id: B7451114 briefTitle: Abrocitinib Taiwan Treatment Pattern and Real World Study in ATopiC Dermatitis (ATTRACT Registry) acronym: ATTRACT overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-11-15 date: 2025-11-15 date: 2024-04-08 date: 2024-04-08 name: Pfizer class: INDUSTRY briefSummary: This study is to describe the real-world treatment patterns and clinical outcomes in moderate-to-severe AD patients receiving abrocitinib over a 12-month observation period, and to describe patient demographic and baseline characteristics. conditions: Dermatitis, Atopic conditions: Dermatitis conditions: Eczema conditions: Skin Diseases conditions: Immune System Diseases conditions: Janus Kinase Inhibitors studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 200 type: ESTIMATED measure: Percentage of Participants Achieving >= 75% Improvement From Baseline in Eczema Area and Severity Index (EASI-75) Response at Week 2, 12, 52 measure: Percentage of Participants Achieving >= 90% Improvement From Baseline in Eczema Area and Severity Index (EASI-90) Response at Week 2, 12, 52 measure: Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response of Clear (0) or Almost Clear (1) and Greater Than or Equal to 2 Points Improvement From Baseline at Week 2, 12, 52 measure: Duration of Abrocitinib Treatment: All Participants measure: Demographic and baseline characteristics measure: Percent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 2, 4, 12, 16, 24, and 52 measure: Change From Baseline in Investigator's Global Assessment (IGA) at Weeks 2, 4, 12, 16, 24, and 52 measure: Change From Baseline in Percentage Body Surface Area at Week 2, 4, 12, 16, 24, and 52 measure: Change From Baseline in Patient-Oriented Eczema Measure (POEM) at Week 2, 4, 12, and 52 measure: Change from baseline of Atopic Dermatitis Control Tool (ADCT) score at Week 2, 4, 12, and 52 measure: Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score to Week 2, 4, 12, and 52 measure: Change From Baseline in Patient Global Assessment (PtGA) measure: Percentage Change From Baseline in Peak Pruritus Numerical Rating Scale (PP-NRS) From Baseline at Weeks 2, 4, 12, 16, 24, and 52 measure: Percentage of Participants Achieving >=4 Points Reduction in Peak Pruritus Numerical Rating Scale (PP-NRS) From Baseline at Week 2, 4, 12, 16, 24, and 52 measure: Percentage of Participants Achieving 0 or 1 in Peak Pruritus Numerical Rating Scale (PP-NRS) From Baseline at Week 2, 4, 12, 16, 24, and 52 sex: ALL minimumAge: 12 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06353074 id: 1335cemre. briefTitle: Uterine Preservation With Acar's Atony Suture for Postpartum Uterine Hemorrhage overallStatus: COMPLETED date: 2021-01-01 date: 2023-11-30 date: 2023-11-30 date: 2024-04-08 date: 2024-04-08 name: Necmettin Erbakan University class: OTHER briefSummary: This study is aimed to show effectiveness of a new suture technique to stop postpartum uterine bleeding due to uterine atony. conditions: Uterine Atony With Hemorrhage conditions: Postpartum Hemorrhage studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: RETROSPECTIVE count: 16 type: ACTUAL measure: Postpartum hysterectomy and/or intensive care unit need ratio sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Cemre Alan city: Konya country: Turkey lat: 37.87135 lon: 32.48464 hasResults: False
<\|newrecord\|> nctId: NCT06353061 id: LACC-MET briefTitle: Chemoradiotherapy With or Without Metformin in Locally Advanced Cervical Cancer overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2025-08-01 date: 2026-02-01 date: 2024-04-08 date: 2024-04-08 name: Peking Union Medical College Hospital class: OTHER briefSummary: This is a prospective, single-center, phase II, randomized, window-of-opportunity trial initiated by researchers. The research hypothesis is that metformin can improve the level of hypoxia in locally advanced cervical cancer and further improve progression-free survival. The study aims to compare the improvement of tumor hypoxia with synchronous chemoradiotherapy with or without metformin, using CA-IX PET/CT and radiation positioning spectral CT to evaluate tumor hypoxia, screening hypoxic patients for inclusion in the study, and comparing the effects of synchronous chemoradiotherapy with or without metformin on the degree of hypoxia and progression-free survival in the two groups of patients. conditions: Cervical Cancer conditions: Radiotherapy conditions: Metformin conditions: Hypoxia conditions: PET/CT studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 51 type: ESTIMATED name: Metformin name: Radiotherapy name: Chemotherapy name: PET/CT measure: The degree to which metformin improves the hypoxic index measured by CAIX PET measure: Progression-free survival（PFS） measure: Changes in tumor volume during treatment measure: Hematologic and gastrointestinal toxicities assessed by CTCAE v5.0 measure: Quality of life assessed by QLQ-C30 sex: FEMALE minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06353048 id: Soh-Med-24-02-04MS briefTitle: Short Term Radiological and Clinical Outcomes of Fixation of Schatzker II Tibial Plateau Fractures by Screws Only Versus Plate and Screws , Comparative Study overallStatus: RECRUITING date: 2024-02-10 date: 2025-02-15 date: 2025-02-15 date: 2024-04-08 date: 2024-04-08 name: Sohag University class: OTHER name: sohag university hospital briefSummary: Tibial plateau fractures are complex injuries produced by high- or low-energy trauma. They principally affect young adults or the 'third age' population ,the tibial plateau is a major weight-bearing surface within the largest and most kinematically complex joint in the human body. Fractures occur as a result of a combination of an axial loading force and a coronal plane (varus/valgus) moment leading to articular shear and depression and mechanical axis malalignment,So Limb alignment and articular surface restoration, allowing early knee motion, are the main goals of surgical treatment.
Soft-tissue damage in fractures around the knee is of critical importance. The oedema and inflammation associated with the trauma can easily lead to local venous compromise, dermal hypoxia, and additional soft-tissue injury. This commonly leads to blistering of the skin and in some cases dermal and even muscle necrosis. Blood-filled blisters should be expected to be associated with a worse outcome than clear fluid-filled ones. Management in the early stages of treatment should focus on preventing further soft-tissue injury while waiting to repair the fracture.
Traditionally, initial radiograph diagnosis should include anteroposterior (AP), lateral and oblique views. But single radiographs do not allow an exact fragment identification and the initial fracture classification can change in 5% to 24% (mean 12%) of cases and treatment can change in up to 26% of cases after CT scan imaging . These findings and the wider availability of CT scanning have made the oblique views less important in the diagnosis. Intra- and peri-articular soft-tissue structures can be affected even in less complex fracture patterns and some X-ray or CT scan data can also suggest the existence of a lateral or medial meniscal tear. Articular depression \> 6 mm and/or articular widening \> 5 mm are associated with the existence of lateral meniscus, lateral collateral ligament (LCL) or posterior cruciate ligament injuries .
Schatzer classification (published in 1974) will be used to complete understanding of the personality of these fracture which is the key element in decision making process when choosing the best possible treatment .
In general ,tibial plateau fracture are to be operated on , but the decision whether to be operated or not on a specific fracture should be based on the fracture morphology ,soft tissues , the patient general condition and the expected limb axis and articular surface restoration.
Usual indications for surgical treatment are :
1. Intra-articular displacement of ⩾ 2 mm
2. Metaphyseal -diaphyseal translation \> 1 cm
3. Angular deformity more than 10 degree in the coronal or sagittal view
4. Open fracture , compartment syndrome and associated ligament injury require repair.
5. Associated fractures of the ipsilateral tibia or fibula
Frequently the depressed articular fragments have to elevated back toward the knee , followed by fixation and sometimes supplemented with bone graft to fill any cancellous bone voids left beneath the joint surface after fracture reduction .
We will evaluate treatment outcomes of closed reduction and percutaneous cannulated screw fixation for tibial plateau fractures versus open reduction and fixation by plate conditions: Tibial Plateau Fractures Schatzker Type II studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: fixation of tibial plateau fractures measure: range of motion of knee joint using Rasmussen score sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sohag university Hospital status: RECRUITING city: Sohag country: Egypt name: Magdy M Amin, professor role: CONTACT lat: 26.55695 lon: 31.69478 hasResults: False
<\|newrecord\|> nctId: NCT06353035 id: NaturalResourcesIFinland id: 346136 type: OTHER_GRANT domain: Strategic Research Council Finland id: 346138 type: OTHER_GRANT domain: Strategic Research Council Finland briefTitle: Biodiversity Interventions for Well-Being acronym: BIWE overallStatus: ACTIVE_NOT_RECRUITING date: 2022-03-30 date: 2027-06-30 date: 2027-09-30 date: 2024-04-08 date: 2024-04-08 name: Natural Resources Institute Finland class: OTHER_GOV name: Tampere University briefSummary: Biodiversity is essential for nature and human well-being. Land use has reduced biodiversity in cities, which weakens the functionality of the urban ecosystems and the well-being of citizens. This may also increase the risk of immune-mediated disorders among urban dwellers.
In Biodiversity interventions for well-being (BIWE), microbial biodiversity interventions are performed to increase biodiversity in urban built areas. Results from the intervention trials are combined with publicly available land cover and ecological data. These are analyzed from the viewpoint of shifts in ecosystems and human well-being and immune regulation, ecological quality, and urban planning.
The investigators set up an intervention study in which urban private yards are rewilded with diverse vegetation and decaying deadwood and plant residuals. The investigators aim to evaluate the effect of rewilding, and yard management practices on commensal microbiome, cortisol levels and well-being and salivary cytokine levels, and gene pathways. conditions: Microbial Colonization conditions: Immune System Diseases conditions: Well-Being, Psychological conditions: Nature, Human studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Intervention-control study in which intervention study subjects private yards are rewilded and control receives no treatment. primaryPurpose: BASIC_SCIENCE masking: NONE maskingDescription: The research subjects were not randomized or masked to the intervention and control group, because the control group needs volunteers who have no intention of following the yard management instructions advised to the intervention group. count: 30 type: ACTUAL name: Rewilding measure: Skin Gammaproteobacteria measure: Salivary cytokines measure: Difference in diversity (Alpha and beta diversity) of skin, saliva and stool microbiota measure: Difference in observed species richness of skin, saliva and stool microbiota measure: Difference in taxonomies of skin, saliva and stool microbiota measure: Difference in microbial gene pathways of saliva and stool microbiota measure: Cortisol levels measure: Perceived Stress Scale measure: Warwick-Edinburgh Mental Wellbeing Scale measure: Depression Scale measure: Nature Relatedness Scale measure: Metabolites in urine measure: Associations between environmental factors and microbial measurements, salivary cytokine levels, hair cortisol levels, perceived well-being sex: ALL minimumAge: 18 Years maximumAge: 72 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Natural Resources Institute Finland city: Helsinki state: Uusimaa zip: 00970 country: Finland lat: 60.16952 lon: 24.93545 hasResults: False
<\|newrecord\|> nctId: NCT06353022 id: RC23_0267 id: 2023-508310-41 type: EUDRACT_NUMBER briefTitle: Minimal Residual Disease-based Strategy With T-Cell Redirector After Treatment With Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone (D-VRd) in Newly Diagnosed Multiple Myeloma acronym: IFm2022-01 overallStatus: NOT_YET_RECRUITING date: 2024-04-20 date: 2026-04-20 date: 2030-06-20 date: 2024-04-08 date: 2024-04-08 name: Nantes University Hospital class: OTHER name: Janssen Pharmaceutica briefSummary: This is a Phase 2 study, open-label, 2-cohort, multicenter, national, interventional in patients with newly diagnosed multiple myeloma. The study will investigate teclistamab (Tec) in combination with lenalidomide (Len) (Tec-Len; Cohort A) or in combination with talquetamab (Tal) (Tec-Tal; Cohort B), allocated based on minimal residual disease (MRD) status (MRD \[-\] \[standard-risk\] vs MRD \[+\] \[high-risk\] respectively).
The patient population will consist of adults men and women at least 18 years to younger than 66 years of age, who meet eligibility criteria. conditions: Multiple Myeloma studyType: INTERVENTIONAL phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 103 type: ESTIMATED name: Teclistamab name: Talquetamab name: Lenalidomide name: Bortezomib name: Daratumumab name: Dexamethasone measure: Rate of sustained MRD negativity (NGS, 10^-5) measure: Rate of conversion from positive MRD to negative MRD (NGS, 10^-5) measure: Number of adverse events measure: Rate of sustained MRD negativity (NGS, 10^-6) measure: Rate of conversion from positive MRD to negative MRD (NGS, 10^-6). measure: Rate of conversion from positive MRD to negative MRD (NGS, 10^-5). measure: Number of the death measure: Number of responses measure: Number of progression-free survival measure: Percentage of duration of response measure: Percenatge of time to response measure: Percentage of value of biological prognostic factors influencing outcome and response. measure: Percentage of score of quality of life sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CH de la Côte Basque city: Bayonne zip: 64109 country: France lat: 43.48333 lon: -1.48333 facility: CHU Caen city: Caen zip: 14033 country: France lat: 49.18585 lon: -0.35912 facility: CHRU DIjon city: Dijon zip: 21000 country: France lat: 47.31667 lon: 5.01667 facility: Chd Vendee city: La Roche-sur-Yon zip: 85925 country: France lat: 46.66667 lon: -1.43333 facility: CHRU LILLE - Hôpital Claude Huriez city: Lille zip: 59037 country: France lat: 50.63297 lon: 3.05858 facility: CHU Limoges city: Limoges zip: 87000 country: France lat: 45.83153 lon: 1.25781 facility: CH Lyon Sud city: Lyon zip: 69495 country: France lat: 45.74848 lon: 4.84669 facility: IPC Marseille Institut Paoli Calmettes city: Marseille zip: 13009 country: France lat: 43.29551 lon: 5.38958 facility: CHU Montpellier city: Montpellier zip: 34295 country: France lat: 43.61092 lon: 3.87723 facility: CHU de Nantes city: Nantes zip: 44093 country: France lat: 47.21725 lon: -1.55336 facility: APHP Hôpital Saint Louis city: Paris zip: 75010 country: France lat: 48.85341 lon: 2.3488 facility: APHP Hôpital Saint-Antoine city: Paris zip: 75012 country: France lat: 48.85341 lon: 2.3488 facility: APHP Hôpital La Pitié Salpétrière city: Paris zip: 75013 country: France lat: 48.85341 lon: 2.3488 facility: CHU BORDEAUX - Hôpital du Haut Lévêque city: Pessac zip: 33604 country: France lat: 44.81011 lon: -0.64129 facility: CHU Poitiers city: Poitiers zip: 86000 country: France lat: 46.58333 lon: 0.33333 facility: CHRU Rennes - Hôpital de Pontchaillou city: Rennes zip: 35033 country: France lat: 48.11198 lon: -1.67429 facility: ICANS Institut de Cancérologie Strasbourg Europe city: Strasbourg zip: 67200 country: France lat: 48.58392 lon: 7.74553 facility: CHU Toulouse city: Toulouse zip: 31059 country: France lat: 43.60426 lon: 1.44367 facility: CHU Tours Hôpital Bretonneau city: Tours zip: 37044 country: France lat: 47.38333 lon: 0.68333 facility: CHRU Nancy - Hôpitaux de Brabois city: Vandœuvre-lès-Nancy zip: 54511 country: France lat: 48.65 lon: 6.18333 hasResults: False
<\|newrecord\|> nctId: NCT06353009 id: ICM 2021-2720 briefTitle: Effect of a Single Ultra-Processed Meal on Myocardial Endothelial Function Assessed With Positron Emission Tomography acronym: SUPPER overallStatus: COMPLETED date: 2020-08-20 date: 2023-04-28 date: 2023-04-28 date: 2024-04-08 date: 2024-04-08 name: Matthieu Pelletier-Galarneau, MD MSc class: OTHER briefSummary: The objective of this study is to evaluate the effect of an ultra-processed meal on myocardial endothelial function using positron emission tomography (PET).
The proposed study is an open-label, randomized crossover clinical trial. Participants will be divided into 2 groups: half of the participants will consume a Mediterranean meal during the first experimental visit and an ultra-processed meal during the second, and vice versa for the other half. The order in which the meals will be consumed will be determined randomly.
This project will contribute to clarify the role of diet in the development and progression of coronary artery disease. The results obtained from this study may potentially demonstrate the harmful effect of ultra-processed foods, even in the short term, on coronary arteries. conditions: Myocardial Endothelial Function studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: BASIC_SCIENCE masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 15 type: ACTUAL name: NOVA4 meal name: NOVA1-3 meal measure: Myocardial blood flow values (ml/min/g) at maximum dose of adenosine. measure: Myocardial blood flow values (ml/min/g) at rest and myocardial reserve. measure: Myocardial blood flow values (ml/min/g) at intermediate dose of adenosine. sex: MALE minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Matthieu Pelletier-Galarneau city: Montreal state: Quebec zip: H1T 1C8 country: Canada lat: 45.50884 lon: -73.58781 hasResults: False
<\|newrecord\|> nctId: NCT06352996 id: Dentist Anas Kassas briefTitle: Three-Dimensional Assessment of Maxillary Canine Retraction With and Without Power Arm overallStatus: ACTIVE_NOT_RECRUITING date: 2023-06-09 date: 2024-03-09 date: 2024-07-30 date: 2024-04-08 date: 2024-04-08 name: Mansoura University class: OTHER briefSummary: Aim of the study: This trial will be conducted for three-dimensional assessment of canine retraction with and without power arm.
Materials and methods:Twenty patients with age range between 14 to 25 years. Before bonding, a hook will be attached to the canine bracket in one side only. Leveling and alignment then The first premolars will be extracted and mini-implant will be inserted.
Canine retraction using nickel titanium closed coil spring will start in the same day of upper first premolar extraction. conditions: Power Arm Canine Retraction studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 20 type: ESTIMATED name: Three-Dimensional Assessment of Maxillary Canine Retraction with Power Arm name: Three-Dimensional Assessment of Maxillary Canine Retraction without Power Arm measure: Canine tipping measure: Canine mobility measure: Implant stability measure: Pain assessment measure: canine rotation measure: canine retraction rate sex: ALL minimumAge: 14 Years maximumAge: 25 Years stdAges: CHILD stdAges: ADULT facility: Faculty of dentistry Mansoura University city: Mansoura country: Egypt lat: 31.03637 lon: 31.38069 hasResults: False
<\|newrecord\|> nctId: NCT06352983 id: 2014/11 briefTitle: Zirconium Dioxide Fixed Dental Prosthesis. overallStatus: COMPLETED date: 2017-12-20 date: 2019-09-27 date: 2023-01-20 date: 2024-04-08 date: 2024-04-08 name: Malmö University class: OTHER briefSummary: The purpose of this clinical trial is to evaluate and compare bridges to replace one or two missing teeth in the mouth. The bridges will be made of two variants of ceramic material. We will evaluate the bridges for up to five years regarding technical and biological complications. conditions: Missing Teeth studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized controlled trial primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: Both participant, care providers, dental technicians and the investigator are blinded in the process. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 31 type: ACTUAL name: Fixed dental prosthesis measure: Fractures measure: De-bonding measure: Caries measure: Endodontic measure: Function measure: Esthetics sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Malmo university city: Malmo state: Skane zip: 214 21 country: Sweden lat: 55.60587 lon: 13.00073 facility: Malmo university city: Malmo state: Skane zip: 21421 country: Sweden lat: 55.60587 lon: 13.00073 hasResults: False
<\|newrecord\|> nctId: NCT06352970 id: LundU-2024 briefTitle: Effects of Tuberculosis Infection on Development and Function of the Placenta overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-12-31 date: 2027-12-31 date: 2024-04-08 date: 2024-04-08 name: Lund University class: OTHER name: Addis Ababa University name: Armauer Hansen Research Institute, Ethiopia briefSummary: The goal of this observational study is to understand how tuberculosis (TB) infection impacts the function and development of the placenta, and whether TB infection can contribute to pregnancy-related disorders through effects on the placenta.
The main questions it aims to answer are:
* Does TB infection affect the structure of the placenta?
* Does TB infection affect the function of the placenta?
Pregnant women attending delivery clinics in Addis Abeba, Ethiopia, will be enrolled and classified for TB infection using a blood-based test. We will compare the following outcomes between women with TB infection and women without TB infection:
* Pathological lesions of the placenta
* Gene and protein expression patterns linked to pregnancy-related disorders
* Infant outcome at birth and at 6 weeks after birth conditions: Pregnancy Related conditions: Tuberculosis Infection conditions: Placenta Diseases studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 500 type: ESTIMATED name: TB infection measure: Proportion of women with pathological placental findings according to the Amsterdam consensus criteria measure: Proportions of women with placental RNA and protein expression patterns linked to pregnancy- related disorders measure: Proportions of infants (born to participating women) with adverse outcome sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06352957 id: 23022022CERC briefTitle: Use of ETElcalcetidefor pReserving vitamiN K-dependent proteIn activiTY ITAlian Study acronym: ETERNITY-ITA overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-12-31 date: 2027-12-31 date: 2024-04-08 date: 2024-04-08 name: Istituto di Fisiologia Clinica CNR class: OTHER briefSummary: The goal of this Prospective Observational Study of comparative effectiveness is to provide real world evidence of the effect of Etelcalcetide in increasing actives form VKDPs levels such as BGP and MGP at 3, 9 and 18 months from baseline, with resulting correct bone mineralization and inhibition vascular calcification in hemodialysis patients.
The study will enroll 160 hemodialysis patients: 80 patients treated with Etelcalcetide and 80 age and sex matched patients treated with Calcitriol or vitamin D analogs. The treating nephrologist will base the target dose of Etelcalcetide on individual-level in order to achieve the KDIGO PTH target. In the Etelcalcetide-treated group, the addition of calcitriol will be allowed when required by clinical practice (for correction of hypocalcemia). The main endpoint is the comparison of the levels of active forms of VKDP (MGP and BGP) between patients treated with Etelcalcetide and those treated with vitamin D or vitamin D analogues. The measurements of the biomarkers are scheduled at baseline and after 3, 9, and 18 months. conditions: Hemodialysis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 160 type: ESTIMATED measure: Levels of VKDP measure: Calcium measure: Phosphate measure: Magnesium measure: ALP measure: PTH measure: 25(OH)D measure: P1NP measure: CTX measure: TRAP 5b measure: BSAP measure: cFGF23 measure: Klotho measure: Sclerostin measure: DKK1 measure: Fetuin A measure: Zinc measure: Irisin measure: Serum Calcification Propensity T50 test measure: Hemoglobin (Hb) measure: Hematocrit (Ht) measure: Plates (PLTS) measure: Reticulocytes measure: Iron measure: Ferritin measure: Transferrin measure: Transferrin Saturation measure: Albumin measure: KT/V measure: Aluminium measure: C-reactive Protein (CRP) measure: Cholesterol measure: Triglycerides measure: Cholesterol HDL measure: Cholesterol LDL measure: Vascular Calcification measure: Vertebral Fractures measure: BMD: Bone Mineral Density measure: Association between Verterbal Fractures and Vascular Calcificatiom measure: Novel quantitative computer-assisted scoring method for vascular calcifications. measure: Effect of Etelcalcetide on cardiovascular events and all-cause mortality. measure: Etelcalcetide Safety: Number of participants with treatment-related adverse events. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06352944 id: AssiutMD briefTitle: Procalcitonin as a Marker of Severity of Non-cystic Fibrosis Bronchiectasis in Children overallStatus: NOT_YET_RECRUITING date: 2024-07 date: 2025-07 date: 2026-07 date: 2024-04-08 date: 2024-04-17 name: Assiut University class: OTHER briefSummary: The aim of this study is to evaluate the role of procalcitonin in bronchoalveolar lavage as a biomarker for assessment of severity of non-CF bronchiectasis in children in correlation with other markers (functional and radiological severity ) conditions: Non-cystic Fibrosis Bronchiectasis studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 30 type: ESTIMATED name: procalcitonin measure: procalcitonin level in bronchoalveolar lavage as a biomarker for assessment of severity of non-CF bronchiectasis in children sex: ALL minimumAge: 6 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT hasResults: False
<\|newrecord\|> nctId: NCT06352931 id: TCD & TCUS in infants briefTitle: Transcranial Ultrasound and Transcranial Doppler in Diagnosis and Detection of Outcome in Infants With Neurological Diseases overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-06-30 date: 2025-07-30 date: 2024-04-08 date: 2024-04-08 name: Assiut University class: OTHER briefSummary: To evaluate the accuracy of transcranial ultrasound in detection of brain pathology in infants with neurological diseases and value of transcranial Doppler in evaluation of intracerebral blood flow in comparison with other radiological modalities according to available imaging. conditions: Trancranial Doppler studyType: OBSERVATIONAL observationalModel: CASE_CROSSOVER timePerspective: CROSS_SECTIONAL count: 50 type: ESTIMATED name: transcranial and transcranial dopp;er measure: To evaluate the accuracy of transcranial ultrasound in detection of brain pathology in infants with neurological diseases and value of transcranial doppler sex: ALL minimumAge: 1 Day maximumAge: 1 Year stdAges: CHILD hasResults: False
<\|newrecord\|> nctId: NCT06352918 id: B.30.2.ATA.0.01.00/395 briefTitle: Peripheral Central Catheter (PICC) Care acronym: PICC overallStatus: COMPLETED date: 2023-05-01 date: 2023-11-30 date: 2023-12-31 date: 2024-04-08 date: 2024-04-08 name: Ataturk University class: OTHER briefSummary: Peripheral Central Catheter (PICC) is one of the painful interventions that are routinely performed repeatedly to establish a safe venous access in preterm babies.Nurses should reduce the pain of babies and ensure their comfort during interventions arising from the necessity of care processes.
Today, it is accepted that tactile stimuli, which have a pain-reducing effect on babies, should be used as a complementary treatment and care method. Palmar grasp reflex is one of the important tactile stimuli to reduce pain and provide comfort in babies. This research will be conducted to examine the effect of palmar grasp reflex stimulation on pain and comfort levels in PICC care in preterm babies. conditions: NEWBORN conditions: Pain, Acute studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: SUPPORTIVE_CARE masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 32 type: ACTUAL name: Palmar grasp reflex stimulation measure: Pain level measure: Comfort sex: ALL minimumAge: 28 Weeks maximumAge: 36 Weeks stdAges: CHILD facility: Ataturk University city: Erzurum zip: 25240 country: Turkey lat: 39.90861 lon: 41.27694 hasResults: False
<\|newrecord\|> nctId: NCT06352905 id: 2157711 briefTitle: Acute Effects of Whole Body Vibration for Individuals With Parkinson Disease overallStatus: RECRUITING date: 2022-09-01 date: 2025-04 date: 2025-04 date: 2024-04-08 date: 2024-04-08 name: Baylor University class: OTHER name: University of St. Augustine for Health Sciences briefSummary: This is an exploratory study to assess the impact of whole body vibration on backward walking speed in people with Parkinson disease. conditions: Parkinson Disease studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: Whole body vibration (WBV) name: Control measure: 3-meter backward walk test (3MBWT) sex: ALL minimumAge: 40 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Baylor University status: RECRUITING city: Waco state: Texas zip: 76798 country: United States name: Anne Boddy role: CONTACT phone: 904-806-2126 email: anne_boddy@baylor.edu lat: 31.54933 lon: -97.14667 hasResults: False
<\|newrecord\|> nctId: NCT06352892 id: 20210201 briefTitle: A Study to Evaluate AMG 133 in Chinese Participants With Obesity or Overweight overallStatus: NOT_YET_RECRUITING date: 2024-04-24 date: 2024-09-03 date: 2024-09-03 date: 2024-04-08 date: 2024-04-08 name: Amgen class: INDUSTRY briefSummary: The main objective of the study is to assess the pharmacokinetics (PK) of AMG 133 after a single subcutaneous (SC) administration in overweight or obese Chinese participants. conditions: Obesity studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: AMG 133 measure: Maximum Observed Plasma Concentration (Cmax) of AMG 133 measure: Area Under the Plasma Concentration-time Curve (AUC) from Time Zero to the Last Quantifiable Concentration (AUClast) of AMG 133 measure: AUC from Time Zero Extrapolated to Infinity (AUCinf) of AMG 133 measure: Number of Participants with Treatment-emergent Adverse Events measure: Number of Participants with Serious Adverse Events measure: Number of Participants with Anti-AMG 133 Antibodies sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06352879 id: 18-Al-KindyCM briefTitle: Prevalence, Types and Risk Factors of Urinary Incontinence Among Women in Baghdad, Iraq. overallStatus: RECRUITING date: 2024-03-01 date: 2024-05-31 date: 2024-06-15 date: 2024-04-08 date: 2024-04-08 name: Al-Kindy College of Medicine class: OTHER briefSummary: The goal of this observational study is to observe and describe the prevalence, types, and risk factors of urinary incontinence (UI) in adult women attending primary healthcare centers in Baghdad, Iraq. The main questions it aims to answer are:
* What is the prevalence of incontinence among the targeted group?
* What are the types of incontinence and what is the frequency of each type among the targeted group?
* What is the effect of several risk factors on the occurrence and severity of urinary incontinence (including age, job, sexual activity, chronic constipation, chronic cough, parity, largest birth weight, and body mass index)? Participants will be asked to fill out a questionnaire consisting of the Arabic International Consultation On Incontinence Questionnaire-Urinary Incontinence Short Form (Arabic ICIQ-UI SF) in addition to questions about the aforementioned risk factors. conditions: Urinary Incontinence conditions: Urge Incontinence conditions: Stress Incontinence studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 384 type: ESTIMATED measure: Arabic International Consultation On Incontinence Questionnaire-Urinary Incontinence Short Form (Arabic ICIQ-UI SF) measure: Risk factors for urinary incontinence sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Baghdad Al- Karkh Health Directorate status: RECRUITING city: Baghdad country: Iraq name: Harth Mohamed Kamber, FICMS (Uro.) role: CONTACT phone: 009647706029071 email: harthkamber@kmc.uobaghdad.edu.iq name: Shahad Hameed Kadhom, MBChB role: PRINCIPAL_INVESTIGATOR lat: 33.34058 lon: 44.40088 facility: Baghdad Al-Russafa Health Directorate status: RECRUITING city: Baghdad country: Iraq name: Harth Mohamed Kamber, FICMS (Uro.) role: CONTACT phone: 009647706029071 email: harthkamber@kmc.uobaghdad.edu.iq name: Shahad Hameed Kadhom, MBChB role: PRINCIPAL_INVESTIGATOR lat: 33.34058 lon: 44.40088 hasResults: False
<\|newrecord\|> nctId: NCT06352866 id: CASE3A23 briefTitle: Siltuximab for Cytokine Release Syndrome Prophylaxis Prior to tx w/ Teclistamab in RRMM overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2025-04-01 date: 2025-12-01 date: 2024-04-08 date: 2024-04-16 name: Jack Khouri class: OTHER briefSummary: The purpose of this study is to examine the safety, efficacy and feasibility of the use of one standard dose of siltuximab prior to teclistamab infusion. Siltuximab is an investigational (experimental) drug that works by binding directly to human interleukin-6 (IL-6). IL-6 is a cytokine; these are products that are secreted by certain cells of the immune system and effect other cells in participant's body. IL-6 regulates immune, inflammatory and metabolic processes. Siltuximab has already been tested and approved for use by the FDA in participants with a condition called multicentric Castleman's disease, which is a lymphoproliferative disorder. This study is being conducted to investigate if administration of a single dose of siltuximab will reduce the rates of and severity of Cytokine Release Syndrome (CRS) and Immune effector Cell-Associated Neurotoxicity Syndrome (ICANS) in participants prior to teclistamab administration. CRS and ICANS are adverse effects commonly experienced by participants being treated with teclistamab that are related to inflammation in the body. Siltuximab is experimental because it is not approved by the Food and Drug Administration (FDA) for prophylactic use prior to administration of teclistamab infusion. conditions: Multiple Myeloma conditions: Cytokine Release Syndrome conditions: Refractory Multiple Myeloma conditions: Immune Effector Cell Associated Neurotoxicity Syndrome studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: This study is an open label single cohort feasibility and efficacy study of siltuximab prophylaxis prior to infusion of teclistamab for treatment of RRMM. There is no planned dose escalation and no separate cohorts.
Participants will receive a single dose of prophylactic siltuximab, 11 mg/kg, 2 hours prior to the administration of the first dose of teclistamab on day 1. There is no planned dose escalation of siltuximab, and teclistamab dosing will be done following the standard planned ramp-up. Participants will be hospitalized for 9 days according to teclistamab package insert and Cleveland Clinic institutional practice. Participants will be followed for the incidence of CRS and ICANS for the first two 22-day cycles of treatment. primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 20 type: ESTIMATED name: Siltuximab name: Teclistamab(FDA-approved) measure: Change in CRS Rate measure: Safety assessment of a single dose of siltuximab as CRS prophylaxis measure: Incidence of grade ≥ 2 cytokine release syndrome after siltuximab prophylaxis measure: Incidence of all grade ICANS after siltuximab prophylaxis measure: Incidence of adverse events after siltuximab prophylaxis measure: Overall response rate measure: Progression free survival measure: Overall survival measure: Hospitalization rates sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Cleveland Clinic Taussig Cancer Center, Case Comprehensive Cancer Center Cleveland, Ohio city: Cleveland state: Ohio zip: 44195 country: United States name: Jack Khouri, MD role: CONTACT phone: 866-223-8100 email: TaussigResearch@ccf.org name: Jack Khouri, MD role: PRINCIPAL_INVESTIGATOR lat: 41.4995 lon: -81.69541 hasResults: False
<\|newrecord\|> nctId: NCT06352853 id: Diathermy and skin incision cs briefTitle: Scalpel Versus Diathermy in Transverse Abdominal Skin Incision During Cesarean Section overallStatus: COMPLETED date: 2022-04-01 date: 2022-09-01 date: 2022-10-01 date: 2024-04-08 date: 2024-04-09 name: Cairo University class: OTHER briefSummary: This study aims to compare between using of diathermy versus scalpel in making skin incision during cesarean section to judge the variations in incisional time, incisional blood loss, postoperative pain, wound healing and wound complications. conditions: Skin Wound studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 120 type: ACTUAL name: Skin incision in Cesarean Section by Diathermy name: Skin incision in Cesarean Section by Scalpel measure: Skin incision time in scalpel versus diathermy group measure: Estimation of incision blood loss in both groups measure: Postoperative pain in both groups measure: Postoperative wound healing in both groups sex: FEMALE minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: Shaimaa El Shemy city: Giza state: Cairo zip: 11562 country: Egypt lat: 30.00808 lon: 31.21093 hasResults: False
<\|newrecord\|> nctId: NCT06352840 id: HUM00231526 id: 5K23HD099283-03 type: NIH link: https://reporter.nih.gov/quickSearch/5K23HD099283-03 briefTitle: Novel Web-based, Self-directed Intervention for Chronic Pelvic Pain overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-04 date: 2026-04 date: 2024-04-08 date: 2024-04-08 name: University of Michigan class: OTHER name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) briefSummary: The study is being completed to evaluate the effectiveness of a web-based, self-management program for patients with Chronic Pelvic Pain (CPP).
The overall hypothesis is that patients with chronic pelvic pain that have access to the My Pelvic Plan program will demonstrate improvements in pain, physical function, and quality of life with this integrative self-management approach. conditions: Chronic Pelvic Pain conditions: Endometriosis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Both participants and outcome assessors will be blinded to study group assignment. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 125 type: ESTIMATED name: My Pelvic Plan Website name: Control Group website measure: Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference short form (SF) 4a between groups measure: PROMIS pain intensity 1a between groups measure: PROMIS Self Efficacy for Managing Symptoms SF 4a between groups measure: Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference short form (SF) 4a between groups measure: PROMIS pain intensity 1a between groups measure: PROMIS Self Efficacy for Managing Symptoms SF 4a between groups sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Michigan city: Ann Arbor state: Michigan zip: 48109 country: United States name: Sara Till, MD role: PRINCIPAL_INVESTIGATOR lat: 42.27756 lon: -83.74088 hasResults: False
<\|newrecord\|> nctId: NCT06352827 id: HUM00228948 id: 1K23DK134752-01 type: NIH link: https://reporter.nih.gov/quickSearch/1K23DK134752-01 briefTitle: Guideline to Implementation: A Rapid Clinical Care Pathway to Care for Patients Affected by Chronic Constipation overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-04 date: 2026-04 date: 2024-04-08 date: 2024-04-08 name: University of Michigan class: OTHER name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) briefSummary: The study is being completed to test the pilot implementation of a rapid clinical care pathway for chronic constipation in the University of Michigan Gastroenterology clinic. This study will learn how often patients get better and how satisfied patients are with care decisions, when seen by a gastroenterologist for medical advice on constipation. conditions: Constipation studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 109 type: ESTIMATED name: Surveys measure: Percentage of encounters in which anorectal physiology testing is ordered or performed at the baseline routine-care gastroenterology office appointment measure: Percentage of encounters in which pelvic floor physical therapy is ordered at the baseline routine-care gastroenterology office appointment measure: Percentage of clinical symptom responders from the Patient Assessment of Constipation-Symptoms (PAC-SYM) measure: Percentage of clinical symptom responders from the Patient Assessment of Constipation-Symptoms (PAC-SYM) measure: Percentage of constipation-specific quality-of-life responders from the Patient Assessment of Constipation-Quality of Life (PAC-QOL) measure: Percentage of constipation-specific quality-of-life responders from the Patient Assessment of Constipation-Quality of Life (PAC-QOL) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Michigan city: Ann Arbor state: Michigan zip: 48109 country: United States name: Brenda Ayala role: CONTACT phone: 734-936-4780 email: beayala@umich.edu name: Eric Shah, MD role: PRINCIPAL_INVESTIGATOR lat: 42.27756 lon: -83.74088 hasResults: False
<\|newrecord\|> nctId: NCT06352814 id: 1977152 briefTitle: Activities-based Locomotor Training Program Versus Traditional Physical Therapy in Children With Cerebral Palsy overallStatus: RECRUITING date: 2024-03-08 date: 2027-05-30 date: 2027-05-30 date: 2024-04-08 date: 2024-04-08 name: Baylor University class: OTHER briefSummary: The purpose of this study is to investigate the impact of an intensive activities-based locomotor training program as compared to traditional physical therapy on activity, participation, and central and peripheral neurophysiological adaptation in children with cerebral palsy. conditions: Cerebral Palsy studyType: OBSERVATIONAL observationalModel: CASE_CROSSOVER timePerspective: PROSPECTIVE count: 30 type: ESTIMATED name: Activities-based locomotor training (physical therapy) measure: Gross Motor Function Measure-66 (GMFM) measure: Pediatric Neuromuscular Recovery Scale (PedsNRS) measure: Pediatric Evaluation of Disability Inventory (PEDI-CAT) measure: Pediatric Quality of Life Inventory CP Module (PedsQL-CP) measure: Functional near-infrared spectroscopy measure: Electromyography measure: ActiGraph sensors sex: ALL minimumAge: 2 Years maximumAge: 6 Years stdAges: CHILD facility: Baylor University status: RECRUITING city: Waco state: Texas zip: 76798 country: United States name: Megan Flores role: CONTACT phone: 512-529-4421 email: megan_flores@baylor.edu lat: 31.54933 lon: -97.14667 hasResults: False
<\|newrecord\|> nctId: NCT06352801 id: EA230530 briefTitle: Effectiveness of Self-Compassion Intervention on Enhancing Self-Compassion and Psychological Well-Being of Children With Attention Deficit/Hyperactivity Disorder overallStatus: RECRUITING date: 2023-12-28 date: 2026-05-31 date: 2026-05-31 date: 2024-04-08 date: 2024-04-09 name: The University of Hong Kong class: OTHER briefSummary: The study aims to investigate the underlying mechanism between Attention Deficit/Hyperactivity Disorder traits (AD/HD traits) and psychological well-being through studying the role of perceived criticism, rejection sensitivity, self-compassion and growth mindset. It also aims to explore the effectiveness of self-compassion intervention on enhancing self-compassion and psychological well-being of children with AD/HD in Hong Kong. The study will contribute to the current understanding of the supportive measures for children with AD/HD, and hopefully help to mobilize more resources to preserve children with AD/HD's mental health.
The intervention program includes the following components:
Participants will be randomly assigned to the self-compassion intervention group or the waitlist control group. The intervention group consists of two parts: children training session and parent group sessions. All children participants will complete a total of 6 training sessions, and each session will last around 90 minutes. Parents of the children participants will also complete a total of 3 group sessions, and each session will last around 90 minutes.
To investigate the intervention effectiveness, children will be asked to complete a questionnaire assessing their levels of self-compassion, emotional regulation, as well as psychological well-being in terms of life satisfaction, positive and negative affect. Parents and teachers of participants will also be asked to complete a questionnaire covering children's emotional regulation, positive and negative affect. Questionnaire data collection will be conducted prior to the intervention (i.e., Time 1), immediately after the 6-session student and 3-session parent sessions (i.e., Time 2), and 2 months after the intervention (i.e., Time 3, a 2-month follow up). It takes approximately 20-30 minutes for children and parents to complete their questionnaires.
Study Objectives:
1. To investigate the underlying mechanism of the relationship between AD/HD traits and psychological well-being
2. To explore the effectiveness of self-compassion intervention on enhancing self-compassion and psychological well-being of children with AD/HD in Hong Kong
Hypotheses:
1. AD/HD traits negatively predicts psychological well-being

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