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Ideation: Adolescent patients with current suicidal ideation. Clinical Population: Psychological or psychiatric patients of the same age and gender without suicidal ideation.
General Population: Adolescents without known psychological or psychiatric pathology of the same age and gender, without suicidal ideation.
Researchers will compare these groups to determine if the AI algorithm is effective in differentiating individuals with suicidal ideation (Group 1) from both a clinical control group (Group 2) and a general population control group (Group 3) using the collected multimodal data. The study aims to assess the algorithm's ability to identify early signs of suicide risk in these distinct participant populations. conditions: Suicide conditions: Distress, Emotional conditions: Adolescent Behavior conditions: Healthy studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 339 type: ESTIMATED measure: Strengths and Difficulties Questionnaire (SDQ) measure: Mood and Feelings Questionnaire (MFQ) measure: Paykel Suicide Scale (PSS) measure: Facial microexpressions, voice and linguistic content analysis measure: Proteomic and stress level analysis measure: Millon Adolescent Clinical Inventory - II (MACI-II) measure: Problematic Internet Use Scale in Adolescents (EUPI-A) measure: European Bullying Intervention Project Questionnaire (EBIP-Q) and European Ciberbullying Intervention Project Questionnaire (ECIP-Q) measure: Oviedo Response Infrequency Scale-Revised (INF-OV-R) sex: ALL minimumAge: 11 Years maximumAge: 16 Years stdAges: CHILD facility: Servizo Galego de Saúde city: Santiago De Compostela state: A Coruña zip: 15703 country: Spain lat: 42.88052 lon: -8.54569 facility: Hospital Álvaro Cunqueiro city: Vigo state: Pontevedra zip: 36211 country: Spain lat: 42.23282 lon: -8.72264 facility: University of Vigo city: Vigo state: Pontevedra zip: 36310 country: Spain lat: 42.23282 lon: -8.72264 facility: University Hospital Complex of Ourense city: Ourense zip: 36002 country: Spain lat: 42.33669 lon: -7.86407 hasResults: False
<|newrecord|> nctId: NCT06341621 id: SCHBCC-N071 briefTitle: Chemotherapy Omission in ER+/HER2- Breast Cancer With 1-3 Positive Lymph Nodes Receiving Extended Adjuvant Abemaciclib acronym: Rainbow overallStatus: RECRUITING date: 2024-04-02 date: 2027-02-25 date: 2029-01-01 date: 2024-04-02 date: 2024-04-10 name: Fudan University class: OTHER briefSummary: This is a prospective, randomized, open-label, multicenter phase III study to explore chemotherapy omission in ER+/HER2-endocrine-sensitive breast cancer with 1-3 positive lymph nodes receiving extended (3 year) adjuvant abemaciclib conditions: Breast Cancer studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Arm 1# endocrine drug plus 3-year abemaciclib without chemotherapy Arm 2# treatment of physician's choice primaryPurpose: TREATMENT masking: NONE count: 1900 type: ESTIMATED name: 3-year abemaciclib without chemo name: treatment of physician's choice measure: Invasive disease free survival measure: disease free survival measure: distant disease free survival measure: overall survival measure: Time Frame: 5 years] 5. adverse effects adverse effects sex: FEMALE minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Zhimin Cancer Shao status: RECRUITING city: Shanghai zip: 200032 country: China name: Zhimin Shao, MD, PhD role: CONTACT phone: +8664175590 email: [email protected] name: Yin Liu, MD role: CONTACT phone: +8664175590 email: [email protected] lat: 31.22222 lon: 121.45806 hasResults: False
<|newrecord|> nctId: NCT06341608 id: K23DA057528 type: NIH link: https://reporter.nih.gov/quickSearch/K23DA057528 briefTitle: Improving Access to Opioid Use Disorder Treatment Among Marginalized Patients With a Tailored Telehealth Intervention overallStatus: RECRUITING date: 2023-12-08 date: 2028-04 date: 2028-04 date: 2024-04-02 date: 2024-04-02 name: University of Pennsylvania class: OTHER briefSummary: The goal of this pilot trial is to develop and test a telehealth intervention for OUD care delivery and refine measurement strategies.
The specific aims are to: 1) identify components of an effective telehealth intervention and barriers to implementation, 2) partner with an advisory board of OUD treatment stakeholders from different settings to develop a telehealth intervention for OUD treatment with buprenorphine, and 3) conduct a pilot trial of the telehealth intervention for OUD treatment.
The investigators will enroll 60 patients, 30 individuals who are currently enrolled in in-person OUD treatment with buprenorphine, with a treatment episode duration of 1-3 months, and 30 individuals who are not currently receiving OUD treatment but approved for treatment intake at buprenorphine clinic by an OUD treatment clinician, to receive the telehealth for OUD care delivery intervention. The investigators will measure clinical, implementation, and patient satisfaction outcomes. conditions: Opioid Use Disorder studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 60 type: ESTIMATED name: Telehealth for opioid use disorder treatment delivery measure: Treatment Engagement measure: Days of medication for OUD measure: Opioid and non-opioid substance use measure: Feasibility of intervention measure: Acceptability measure: Fidelity measure: Patient satisfaction sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Pennsylvania status: RECRUITING city: Philadelphia state: Pennsylvania zip: 19104 country: United States name: Shoshana Aronowitz, PhD role: CONTACT phone: 781-266-8571 email: [email protected] lat: 39.95233 lon: -75.16379 hasResults: False
<|newrecord|> nctId: NCT06341595 id: 123322 briefTitle: Concurrent Chemoradiotherapy Combined With Sintilimab as Neoadjuvant Therapy for GC Patients With PALM overallStatus: RECRUITING date: 2024-04-01 date: 2025-12-31 date: 2026-12-31 date: 2024-04-02 date: 2024-04-02 name: The First Affiliated Hospital with Nanjing Medical University class: OTHER briefSummary: This trial is a prospective, single arm, single center, phase II clinical study aimed at subjects with advanced gastric cancer and para aortic lymph node metastasis, exploring the feasibility and safety of Sintilimab Injection combined with synchronous chemo-radiotherapy as neoadjuvant therapy.
Patients will receive sintilimab Injection (200mg iv q3w d1) combined with concurrent radiotherapy and chemotherapy. The chemotherapy regimen will use oxaliplatin 130mg/m2+S-1 40mg/m2 bid d1-14. Radiotherapy is performed using intraperitoneal radiation therapy, once a day, five times a week, at a dose of 1.8-2 Gy/f, for a total of 45-50.4 Gy (60-66 Gy for lymph node lesions). Radiation therapy starts from the second cycle of Sintilimab Injection combined with chemotherapy. The subjects underwent imaging evaluation after completing 4 cycles of combination chemotherapy and radiation therapy with Sintilimab Injection. Evaluated as a surgical subject (surgical conditions: imaging evaluation of enlarged lymph nodes adjacent to the abdominal aorta with PR or no significant activity), radical surgery will be performed within 4 weeks after the last study drug treatment. After surgery, the researcher will determine the necessity of adjuvant treatment and develop an adjuvant treatment plan based on the subject's condition. Subjects evaluated as inoperable will have their best follow-up treatment plan determined by the researcher. conditions: Gastric Cancer conditions: Gastric Cancer Metastatic to Regional Lymph Nodes studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: Sintilimab name: Extraperitoneal radiation therapy name: Oxaliplatin name: S-1 measure: Recurrence free survival (RFS) measure: R0 resection rate measure: Objective response rate (ORR) measure: Major pathological response rate (MPR) measure: Overall survival (OS) measure: Adverse reactions sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Jiangsu Province Hospital status: RECRUITING city: Nanjing state: Jiangsu zip: 210029 country: China name: Yang Yan role: CONTACT lat: 32.06167 lon: 118.77778 hasResults: False
<|newrecord|> nctId: NCT06341582 id: 2023-10-14 briefTitle: Prediction and Evaluation by ETCOc of Neonatal Hyperbilirubinemia Cohort acronym: PREVENT overallStatus: RECRUITING date: 2023-12-11 date: 2025-11 date: 2025-11 date: 2024-04-02 date: 2024-04-02 name: Guangzhou Women and Children's Medical Center class: OTHER briefSummary: The hemolytic disease of newborns (HDN) is one of the most significant risk factors for hyperbilirubinemia. Studies have shown that end-tidal carbon monoxide-corrected (ETCOc) correlated with the rate of bilirubin production in the body and thus can be a good surrogate to quantify hemolysis and identifying the high-risk infants. However, there is insufficient clinical evidence regarding the early prediction of hemolytic hyperbilirubinemia using ETCOc. This study hypothesizes that early postnatal ETCOc levels are significantly associated with the risk of hemolytic hyperbilirubinemia requiring treatments within 14 days after birth, and early postnatal ETCOc can be a good indicator for early prediction of hemolysis. In addition, the investigators aim to investigate the relationship between the characteristics of treatments for hyperbilirubinemia and ETCOc. conditions: Neonatal Jaundice conditions: Neonatal Hyperbilirubinemia conditions: Hemolysis Neonatal studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 2700 type: ESTIMATED name: End-tidal carbon monoxide-corrected (ETCOc) measure: The incidence of hemolytic hyperbilirubinemia within 14 days of life (DOL) measure: The incidence of neonatal hyperbilirubinemia within 14 days of life (DOL) measure: The incidence of hemolytic diseases of newborns within 14 days of life (DOL) measure: The rate of readmission due to neonatal hyperbilirubinemia within 28 days of life (DOL) sex: ALL minimumAge: 1 Hour maximumAge: 72 Hours stdAges: CHILD facility: Dongguan Maternity and Child Healthcare Hospital status: NOT_YET_RECRUITING city: Dongguan state: Guangdong zip: 523700 country: China name: Minxu Li, M.D. role: PRINCIPAL_INVESTIGATOR lat: 23.01797 lon: 113.74866 facility: Foshan Shunde Women and Children Health Care Hospital status: NOT_YET_RECRUITING city: Foshan state: Guangdong zip: 528300 country: China name: Runzhong Huang, M.D. role: PRINCIPAL_INVESTIGATOR lat: 23.02677 lon: 113.13148 facility: Guangdong Maternity and Child Healthcare Hospital status: NOT_YET_RECRUITING city: Guangzhou state: Guangdong zip: 510010 country: China name: Chuan Nie, M.D. role: PRINCIPAL_INVESTIGATOR lat: 23.11667 lon: 113.25 facility: The First affiliated Hospital, Sun Yat-sen University status: NOT_YET_RECRUITING city: Guangzhou state: Guangdong zip: 510080 country: China name: Muxue Yu, M.D. role: PRINCIPAL_INVESTIGATOR lat: 23.11667 lon: 113.25 facility: Guangzhou Women and Children's Medical Center status: RECRUITING city: Guangzhou state: Guangdong zip: 510623 country: China name: Ge Yang, M.D. role: CONTACT phone: (86)020-38076329 email: [email protected] name: Huayan Zhang, M.D. role: PRINCIPAL_INVESTIGATOR lat: 23.11667 lon: 113.25 facility: The First Affiliated Hospital of Jinan University, Guangzhou Overseas Chinese Hospital status: NOT_YET_RECRUITING city: Guangzhou state: Guangdong zip: 510632 country: China name: Bingxiao Li, M.D. role: PRINCIPAL_INVESTIGATOR name: Shasha Han, M.D. role: PRINCIPAL_INVESTIGATOR lat: 23.11667 lon: 113.25 facility: Shenzhen Maternity and Child Healthcare Hospital status: NOT_YET_RECRUITING city: Shenzhen state: Guangdong zip: 518000 country: China name: Chuanzhong Yang, M.D. role: PRINCIPAL_INVESTIGATOR lat: 22.54554 lon: 114.0683 hasResults: False
<|newrecord|> nctId: NCT06341569 id: 11/07.03.2024 briefTitle: Physical Therapy Students: Well-being overallStatus: NOT_YET_RECRUITING date: 2024-04-11 date: 2024-08-29 date: 2024-10-30 date: 2024-04-02 date: 2024-04-10 name: University of Medicine and Pharmacy "Victor Babes" Timisoara class: OTHER briefSummary: This study aims to explore various psychosocial aspects and the potential benefits of respiratory techniques for physical therapy students. conditions: Anxiety State conditions: Motivation conditions: Life Stress conditions: Sleep, Inadequate studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: FACTORIAL interventionModelDescription: This study uses a multiple-group design to investigate various psychosocial aspects of physical therapy students and to explore the potential benefits of breathing techniques as a well-being-promoting intervention. The study involves three groups:
Intervention group: second-year physical therapy students participating in a 14-week breathing techniques program.
Control group: second-year physical therapy students who do not participate in the program but complete the same questionnaires.
Comparison groups: 1st, 2nd, and 3rd year physical therapy students participating in assessments only. primaryPurpose: SCREENING masking: NONE count: 150 type: ESTIMATED name: Respiratory breathing techniques group measure: Assessing intrinsic and extrinsic motivation levels among physical therapy students. measure: Assessing the happiness levels of the students participating in the study. measure: Assessing the positive and negative emotional states of the students participating in the study. measure: Assessing the well-being of the students participating in the study. measure: Assessing the overall life satisfaction levels of the students participating in the study. measure: Assessing the subjective happiness levels of the students participating in the study. measure: Assessing the sleep quality of the students participating in the study. measure: Assessing the worry and anxiety levels of the students participating in the study. measure: Assessing the effects of the respiratory techniques program on the intrinsic and extrinsic motivation levels of the students participating in the study. measure: Assessing the effects of the respiratory techniques program on the happiness levels of the students participating in the study. measure: Assessing the effects of the respiratory techniques program on the students' positive and negative emotional states. measure: Assessing the effects of the respiratory techniques program on the students' well-being. measure: Assessing the effects of the respiratory techniques program on the overall life satisfaction levels of the students participating in the study. measure: Assessing the effects of the respiratory techniques program on the subjective happiness levels of the students participating in the study. measure: Assessing the effects of the respiratory techniques program on the quality of sleep of the students participating in the study. measure: Assessing the effects of the respiratory techniques program on the worry and anxiety levels of the students participating in the study. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<|newrecord|> nctId: NCT06341556 id: iNHL-03 briefTitle: A Multicenter, Prospective, Phase II Study of Zanubrutinib for Maintenance in Patients With Mantle Cell Lymphoma overallStatus: RECRUITING date: 2024-04 date: 2026-03 date: 2028-06 date: 2024-04-02 date: 2024-04-02 name: Fudan University class: OTHER briefSummary: This study aims to evaluate whether maintenance therapy with Zanubrutinib monotherapy could improve the 2-year progression free survival (PFS) of patients with mantle cell lymphoma who had remission after first-line immunochemotherapy conditions: Mantle Cell Lymphoma conditions: Maintenance Therapy studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 52 type: ESTIMATED name: Zanubrutinib measure: 2-year progression-free survival (PFS) measure: 2-year event-free survival (EFS) measure: overall survival measure: Hematology and non hematology toxicity measure: Quality of life questionnaire measure: Exploratory biomarkers sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fudan University Shanghai Cancer Center status: RECRUITING city: Shanghai state: Shanghai zip: 200032 country: China name: Yizhen Liu role: CONTACT phone: 021-64175590 phoneExt: 85100 email: [email protected] lat: 31.22222 lon: 121.45806 facility: Shanghai Cancer Center status: RECRUITING city: Shanghai state: Shanghai zip: 200032 country: China name: Yizhen Liu role: CONTACT phone: 021-64175590 phoneExt: 85100 email: [email protected] lat: 31.22222 lon: 121.45806 hasResults: False
<|newrecord|> nctId: NCT06341543 id: QUANTIFOT id: PHRCI-2021-68 type: OTHER_GRANT domain: DGOS (France) briefTitle: Quantiferon CMV to Identify Treatment Need For Asymptomatic CMV Infection After Solid Organ Transplant (QUANTIFOT) acronym: QUANTIFOT overallStatus: NOT_YET_RECRUITING date: 2024-04-25 date: 2026-06-15 date: 2026-06-15 date: 2024-04-02 date: 2024-04-10 name: University Hospital, Grenoble class: OTHER briefSummary: Context
Cytomegalovirus (CMV) infection is a frequent and potentially severe event in solid organ transplant (SOT) recipients.
Most of available treatment display adverse effects that limit their use. Therefore, in case of an infection, it is of primary importance to identify the patients at high risk of severe infection and/or disease, and who ill benefit the most from antiviral therapy.
As CMV infection is mainly controlled by cellular immunity, measuring specific anti-CMV T lymphocyte immunity could be an interesting tool for identifying these at-risk individuals. One of these tests is the QuantiFERON-CMV (QF-CMV) assay (QuiagenTM, Courtabœuf, France).
Aim of the study
The aim of the study is to determine the extent to which the QF-CMV can be use to identify, among SOT recipients with a CMV viremia, those that may not need antiviral therapy.
Methods
Participation to the study will be proposed to SOT recipients with an asymptomatic CMV infection with a blood viral load between 1,000 and 15,000 IU/mL.
The QF-CMV will be performed in included participants, and the result will be given or not to the clinician in charge (according to the attributed group through randomisation).
* In the group without result communication, the clinician in charge will determine whether a treatment is needed according to the guidelines and the local practices.
* in the group with result communication, the clinician in charge will be advised not to introduce antiviral therapy if the result is positive, and to determine whether a treatment is needed according to the guidelines and the local practices if the result is positive.
In the following weeks, the viral load will be monitored, along with creatininemia, cell blood count, and kalemia (to detect antiviral adverse effect).
The participants will be sampled:
* 5 to 12 days after QF-CMV sampling (V2) ;
* 7 to 14 days days after V2 (V3 - between D12 and D26) ;
* 7 to 14 days days after V3 (V4 - between D19 and D40) .
Endpoints
The primary endpoint is the rate of uncontrolled infection 5 to 12 days after QF-CMV sampling, defined as follows:
* Blood CMV viral load \>10,000 IU/mL \[4 log\];
* And/or increase in blood viral load ≥0.5 log IU/mL with CV otherwise \>5000 IU/mL;
* And/or the onset of CMV disease.
The secondary endpoint is the is the occurrence antiviral adverse effects (hematoxicity or nephrotoxicity). conditions: Cytomegalovirus Infections conditions: Heart Transplantation conditions: Kidney Transplantation conditions: Lung Transplantation conditions: Liver Transplantation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 288 type: ESTIMATED name: Quantiferon CMV (assay that determine the presence of CMV-specific T lymphocytes). name: Communication of the result of the QF-CMV to the clinician in charge measure: proportion of participants with CMV viral load (>10,000 IU/mL, or increase ≥0.5 log IU/mL) measure: proportion of participants with CMV disease measure: proportion of participants with antiviral-associated anemia measure: proportion of participants with antiviral-associated leucopenia measure: proportion of participants with antiviral-associated thrombopenia measure: proportion of participants with antiviral-associated tubulotoxicity (hypokaliemia) measure: antiviral-associated kidney failure (creatininemia) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Olivier EPAULARD city: Grenoble state: Isere zip: 38043 country: France name: Olivier Epaulard role: CONTACT phone: +00476765291 email: [email protected] lat: 45.16667 lon: 5.71667 hasResults: False
<|newrecord|> nctId: NCT06341530 id: SURPASS-1 briefTitle: Anlotinib Combined With Penpulimab as Front-line Treatment in Advanced Non-small Cell Lung Cancer overallStatus: RECRUITING date: 2024-01-31 date: 2024-12-31 date: 2025-12-31 date: 2024-04-02 date: 2024-04-02 name: The First Affiliated Hospital of Zhengzhou University class: OTHER briefSummary: In recent years, with the emergence and clinical application of anti-angiogenesis therapy, the therapeutic effect of patients has been significantly improved while ensuring that the adverse reactions of patients do not increase. Anti-angiogenic therapy can improve the hypoxia state of tumor tissue, normalize blood vessels, relieve immune suppression in tumor microenvironment, increase the degree of infiltration of immune cells, and fully activate immune cells to achieve the effect of tumor immunity. Previous studies have shown that penpulimab injection combined with anlotinib in the treatment of NSCLC can induce the normalization of tumor blood vessels and reshape the tumor immunosuppressive microenvironment, and the combination of the two can have synergistic effects.
This study intends to treat patients with advanced non-small cell lung cancer (NSCLC) confirmed by pathology with the combination of anlotinib and penpulimab injection, and observe the efficacy and safety of anlotinib and penpulimab injection in the first and second lines of NSCLC. This study is expected to provide a reference for the treatment strategy of advanced non-small cell lung cancer patients, and has important clinical value for the treatment of advanced lung cancer. conditions: Non-small Cell Lung Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 33 type: ESTIMATED name: anlotinib combined with penpulimab measure: Progression-free survival sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Zhe Cheng status: RECRUITING city: Zhengzhou state: Henan zip: 450000 country: China name: Zhe Cheng role: CONTACT phone: 18638027777 email: [email protected] lat: 34.75778 lon: 113.64861 hasResults: False
<|newrecord|> nctId: NCT06341517 id: IRB_in_progress briefTitle: Brain Circuitry Therapeutics for Schizophrenia acronym: ATHENA overallStatus: NOT_YET_RECRUITING date: 2024-11-05 date: 2026-01-05 date: 2027-12-12 date: 2024-04-02 date: 2024-04-02 name: Indrit Begue class: OTHER briefSummary: This project is a double blind randomized clinical trials that examines the efficacy of cerebellar non invasive stimulation for apathy improvement in patients with schizophrenia conditions: Schizophrenia; Psychosis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: The subjects, care providers, investigators and outcome assessors will all be blinded as to the randomization sequence, and thus will be blinded as to sham vs active TMS status. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 70 type: ESTIMATED name: iTBS measure: Brief Negative Symptoms Scale - apathy subscale (BNSS-Apathy) at follow-up (FU) at T3. The primary endpoint will be assessed at baseline and all follow-up visits at week 1, 6 and 12. sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Indrit Bègue city: Geneva zip: 1202 country: Switzerland name: Indrit Bègue, MD, PhD role: CONTACT phone: +41589440300 email: [email protected] lat: 46.20222 lon: 6.14569 hasResults: False
<|newrecord|> nctId: NCT06341504 id: ALVMsg2023 id: 263472 type: OTHER_GRANT domain: Fonds de recherche du Québec - Société et culture briefTitle: Prevention Messages for EGMs: Effects on Behaviours and Cognitions overallStatus: RECRUITING date: 2024-02-27 date: 2024-09 date: 2024-09 date: 2024-04-02 date: 2024-04-02 name: Benjamin Galipeau class: OTHER name: Fonds de recherche du Québec - Société et culture name: Fonds pour la prévention et le traitement du jeu briefSummary: The goals of this randomized controlled trial are to test the manifold effects of prevention pop-up messages on participants' behaviours, cognitions and affects. This study is conducted among regular EGMs' players (defined as having played EGMs at least once every two weeks for the past 12 months) who are not classified as probable pathological gamblers by the PGSI.
After answering a series of short questionnaires by phone, participants are asked to schedule a gambling session which is done in a laboratory on the university's campus. This laboratory replicates a typical bar, and is equipped with real EGMs. Participants are recruited under the false pretense of giving their opinion on the realism of the bar replica, and on the overall feeling of the gambling session in it. They are told that: (a) they are free to gamble as much and for as long as they like; (b) they are allowed to take breaks; (c) gambling is to be done with their own money; (d) the only compensation for participation are the potential winnings made while gambling; (e) net winnings across their whole session are paid, but losses are real. There is only one participant at a time in the laboratory for the gambling session.
After having stopped by their own volition (some exceptions apply, see "Detailed Description" for further details), participants are debriefed on the real goals of this study and reimbursed any incurred losses while gambling. They are then be asked to answer another series of questionnaires. conditions: Gambling studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Stratified block randomization assignment. Blocks are size 4 and strata are divided on problem gambling severity using PGSI categories. Two conditions:
* Experimental: Regular gambling session + Prevention pop-up messages
* Active Comparator: Regular gambling session
Three assessment phases:
* Pre-experiment. Telephone interview before the gambling session. Measures baseline characteristics and schedule the gambling session. Usually done within a couple of days following an application to participate.
* Experiment. Gambling session in the laboratory. Behaviour is continuously measured starting with the first time the participant puts money in the EGM to participant choosing to end their gambling session. Duration is limited to 2 hrs (unbeknownst to participant). Session is scheduled days to weeks after the Pre-experiment, depending on participant's availability.
* Post-experiment. Debriefing and post-experiment interview. Done right after the gambling session is ended. primaryPurpose: PREVENTION masking: SINGLE maskingDescription: Participants are recruited under the false pretense of evaluating the realism of a gambling session in a laboratory replicating a bar environment. While the participants in the experimental group should notice the novel prevention messages, before debriefing, for all they know, there are no groups to be assigned to. Therefore they would not be aware, that there are two different groups, nor that this study tests the effects of prevention pop-up messages.
Note that masking becomes "open label" after debriefing. Indeed, after being informed of the true goals of this study, participants will easily be able to determine in which group they were assigned based on what occured during their gambling session. Though, gambling behaviours are recorded before debriefing and won't be affected by unmasking.
There is no functional way to mask group assignment to the members of the research team. However, the randomization procedure assures that allocation is purely random. whoMasked: PARTICIPANT count: 80 type: ESTIMATED name: Prevention pop-up messages name: Mandatory time limit name: Responsible gambling information name: Electronic gambling machine (model IGT GL20) name: Square terminal measure: Gambling behaviour (between group) - Gambling session's total duration measure: Gambling behaviour (between group) - Total time effectively spent gambling measure: Gambling behaviour (between group) - Number of breaks taken measure: Gambling behaviour (between group) - Mean breaks' duration measure: Gambling behaviour (between group) - Total breaks duration measure: Gambling behaviour (between group) - Mean time elapsed between breaks measure: Gambling behaviour (between group) - Number of different games played measure: Gambling behaviour (between group) - Money betted (physical) measure: Gambling behaviour (between group) - Money betted (all) measure: Gambling behaviour (between group) - Number of bets placed measure: Gambling behaviour (between group) - Gambling speed measure: Gambling behaviour (between group) - Gambling intensity (physical) measure: Gambling behaviour (between group) - Gambling intensity (all) measure: Perceived self-control while gambling on EGMs (between group) measure: General level of fun while gambling on EGMs (between group) measure: Psychological reactance to prevention pop-up messages (between group) measure: Perceived behavioural effectiveness of prevention pop-up messages (between group) measure: Change in gambling behaviours (within group) - Money betted (physical) measure: Change in gambling behaviours (within group) - Total time effectively spent gambling measure: Change in perceived self-control while gambling on EGMs (within group) measure: Change in general level of fun while gambling on EGMs (within group) measure: Perceived realism - Gambling location type most resembling the session in the laboratory measure: Perceived realism - Session in the laboratory VS gambling on EGMs in a bar/restaurant measure: Perceived realism - Similarities between session in the laboratory VS gambling on EGMs in a bar/restaurant measure: Perceived realism - Differences between session in the laboratory VS gambling on EGMs in a bar/restaurant measure: Perceived realism - What could be done to heighten realism of the session in the laboratory measure: Perceived realism - Effect of using one own money on realism measure: Perceived realism - Effect of using one own money on realism (free) measure: Perceived correspondence between habitual gambling behaviour and gambling behaviour during the session in the laboratory measure: Perceived correspondence between habitual gambling behaviour and gambling behaviour during the session in the laboratory (free) measure: Protocol credibility measure: Protocol credibility (free) measure: Recruitment potential - Volunteers measure: Recruitment potential - Recruited measure: Recruitment potential - Rejected measure: Recruitment potential - Refusal measure: Attrition measure: Prevention pop-up messages recall - Free recall (Y/N) measure: Prevention pop-up messages recall - Free recall (number) measure: Prevention pop-up messages recall - Free recall (content) measure: Prevention pop-up messages recall - Cued recall (Y/N) measure: Prevention pop-up messages recall - Cued recall (number) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Centre québécois d'excellence pour la prévention et le traitement du jeu status: RECRUITING city: Québec zip: G1V 0A6 country: Canada name: Benjamin Galipeau role: CONTACT email: [email protected] name: Christian Jacques, M.Ps. role: CONTACT email: [email protected] name: Benjamin Galipeau role: PRINCIPAL_INVESTIGATOR name: Isabelle Giroux, Ph.D. role: PRINCIPAL_INVESTIGATOR name: Serge Sévigny, Ph.D. role: PRINCIPAL_INVESTIGATOR name: Christian Jacques, M.Ps. role: SUB_INVESTIGATOR lat: 46.81228 lon: -71.21454 hasResults: False
<|newrecord|> nctId: NCT06341491 id: obs. Delay Discounting briefTitle: The Study of Delay Discounting Among Beneficiaries of the Pé-de-Meia Program overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-04-30 date: 2025-12-01 date: 2024-04-02 date: 2024-04-02 name: Federal Institute of Education, Science and Technology of the State of Mato Grosso class: OTHER briefSummary: The aim of this observational study is to explore how the "Pé-de-Meia" Program, a policy of the Brazilian Federal Government designed to encourage the retention and completion of studies by students from low-income families, affects both the students' tendency towards delay discounting and their academic performance. The study seeks to answer the following questions:
How does the "Pé-de-Meia" Program affect the students' propensity for delay discounting? Is there a relationship between the level of delay discounting among students, their academic performance, and school attendance? Participants in the study, high school students enrolled in the "Pé-de-Meia" Program, will undergo assessments to measure their level of delay discounting. The academic performance and school attendance of the participants will be monitored and analyzed in relation to their propensity for delay discounting conditions: Delay Discounting studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 120 type: ESTIMATED name: Pé-de-Meia Program measure: Delay discounting measure: Academic performance - grades measure: School attendance sex: ALL minimumAge: 14 Years maximumAge: 24 Years stdAges: CHILD stdAges: ADULT hasResults: False
<|newrecord|> nctId: NCT06341478 id: IG-2022-27746 briefTitle: Investigator Grant (IG) 2022 27746 overallStatus: RECRUITING date: 2024-03-15 date: 2026-03-15 date: 2027-03-15 date: 2024-04-02 date: 2024-04-02 name: IRCCS San Raffaele class: OTHER briefSummary: Background:
Muscle-invasive bladder cancer (MIBC) is a systemic disease as \>40% of patients (pts) ultimately develop recurrence after radical cystectomy (RC). For pts who cannot receive or refuse cisplatin-based chemotherapy there is no standard-of-care neoadjuvant therapy. Single-agent pembrolizumab, given neoadjuvantly in patients with T2-4N0M0 MIBC, documented a 42% pathologic complete response-rate (ypT0N0) in a previous AIRC-supported trial (PURE-01, NCT02736266; PMID: 30343614). However, there is a huge proportion of pts who do not benefit from single-agent immunotherapy. Antibody-drug conjugates (ADC) represent the next wave of MIBC treatment revolution. An umbrella of various neoadjuvant therapies including the ADC Sacituzumab govitecan (SG), SG plus pembrolizumab, and chemoimmunotherapy combination has been established to improve our knowledge on MIBC biology and to improve the outcomes.
Hypothesis:
By developing a robust biomarker program associated with therapeutic benefit of novel therapies or their combinations, along with an imaging biomarker development, the investigators will be able to identify suitable tumor characteristics for personalizing perioperative therapies in MIBC, coupled with the possibility to predict the pathological response to treatment.
Aims:
The project is aimed at characterizing the tumor and microenvironment characteristics of muscle-invasive bladder cancer, with a special focus on their changes induced by various neoadjuvant therapies preceding radical cystectomy.
The investigators will aim to evaluate the tumor and immune profile on matched pre- vs post-therapy samples and noninvasively monitor the response to treatment with the use of radiological assessments.