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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: zhimingshao@yahoo.com name: Yin Liu, MD role: CONTACT phone: +8664175590 email: liuyinfudan@163.com 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: visho@nursing.upenn.edu 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: geyang99@outlook.com 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: aliuyz@126.com 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: aliuyz@126.com 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: oepaulard@chu-grenoble.fr 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: cz711010@163.com 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: indrit.begue@unige.ch 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: benjamin.galipeau.1@ulaval.ca name: Christian Jacques, M.Ps. role: CONTACT email: christian.jacques@psy.ulaval.ca 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.
Experimental design:
The investigators will access tumor samples from matched pre-therapy (transurethral resection of the bladder tumor) and post-therapy (radical cystectomy) surgical interventions. They will also analyze the imaging analyses of combined bladder multiparametric MRI/Fluorodeoxyglucose Positron Emission Tomography (PET) scans pre-post neoadjuvant therapies, and will associate the data with the pathological response to treatment, expanding our previously reported work (PMID: 31882281).
Biomarker analyses will include the following: i.) multiplex immunofluorescence assays will allow the investigators defining the immune contexture of tumor lesion; ii.) multiparametric flow cytometry will allow the phenotypic and functional analysis of peripheral blood cells at single cell level; iii.) a whole transcriptome assay will enable investigators to assign specific molecular subtypes to pathological response and outcome, as previously reported (PMID: 33785257; 32165065).
Expected results:
The investigators will expect to identify the tumor characteristics and immune-profiling enabling them to delineate the selection of patients most suited for certain novel perioperative therapies, thus anticipating the developments in clinical research that are being conducted worldwide in MIBC.
The investigators will be also able to develop noninvasive tools for pathological complete response identification, thus enabling them to develop a next-generation of clinical trials aimed at sparing any radical local therapy on the bladder tumor.
Impact on cancer:
In principle, the present personalized strategy yields the potential to enhance the therapeutic standards achievable with RC alone as well as with single-agent immunotherapy and RC. conditions: Bladder Cancer studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Post-hoc biomarker analyses of ongoing phase 2 studies primaryPurpose: OTHER masking: NONE count: 153 type: ESTIMATED name: various neoadjuvant therapies measure: Predictors of immune response to experimental combination therapies in MIBC. measure: Genomic predictors of response to experimental combination therapies in MIBC. measure: Transcriptomic predictors of response to experimental combination therapies in MIBC. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Ospedale San Raffaele status: RECRUITING city: Milan state: Mi zip: 20132 country: Italy name: Andrea Necchi, MD role: CONTACT phone: +390226435789 email: necchi.andrea@hsr.it name: Rossella Miotti, PhD role: CONTACT email: miotti.rossella@hsr.it lat: 45.46427 lon: 9.18951 typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2023-02-02 uploadDate: 2024-03-19T18:02 filename: Prot_000.pdf size: 1464434 hasResults: False
<\|newrecord\|> nctId: NCT06341465 id: HÜ- FTR- BD- 3 briefTitle: Investigation of the Effects of Exercise and Kinesiological Taping on Spinal Deformities and Serum Markers in Individuals With Scoliosis overallStatus: NOT_YET_RECRUITING date: 2024-04-04 date: 2024-07-04 date: 2024-07-04 date: 2024-04-02 date: 2024-04-02 name: Hacettepe University class: OTHER briefSummary: The aim of this study is to investigate the effects of Schroth exercises and kinesiological taping on spinal deformities and serum markers in young adults with scoliosis. The study will include young adults aged 18-21 with scoliosis. A total of 57 participants will be included in the study. Out of 57 participants, 38 have scoliosis, and 19 are healthy. 38 participants will be randomly divided into 2 groups. One group (n=19) will receive only Schroth exercises, and the other group (n=19) will receive both Schroth exercises and kinesiological taping. The laboratory analyses of proteins associated with autophagy (Beclin-1, LC3, and ATG3) and bone-cartilage metabolism (COMP and MMP-3) will be conducted in the Biomedical Engineering Laboratory of our university. Trunk rotation will be assessed using the Adams Forward Bend Test with scoliometer, quality of life will be evaluated with the SRS-22 Quality of Life questionnaire and Quality of life profile for spinal deformities questionnaire, perception of deformity will be measured using the Walter Reed Visual Assessment Scale, and Cobb angles will be evaluated from anterior-posterior X-ray images. conditions: Scoliosis conditions: Scoliosis Idiopathic conditions: Musculoskeletal Deformity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: 3 groups. Schroth exercise group (n=19), schroth exercise and kinesiological taping group (n=19), healthy people (n=19). primaryPurpose: TREATMENT masking: NONE count: 57 type: ESTIMATED name: Just Exercise name: Exercise name: Taping measure: Trunk rotation measure: Cobb angles measure: Serum markers measure: Quality of life with scoliosis people measure: Body image assessment sex: ALL minimumAge: 18 Years maximumAge: 21 Years stdAges: ADULT hasResults: False
<\|newrecord\|> nctId: NCT06341452 id: HD-NaM-01-EU briefTitle: Comparison of Individualized Sodium Management Versus Standard Treatment in Hemodialysis acronym: SODIAH overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2025-03 date: 2025-12 date: 2024-04-02 date: 2024-04-02 name: Fresenius Medical Care Deutschland GmbH class: INDUSTRY briefSummary: The SODIAH study is designed with the aim to assess the impact of isonatremic dialysis on interdialytic weight gain, fluid status, intradialytic hemodynamic stability, and incidence of intradialytic morbid events in dialysis patients. The study will be comparing the Na management option on the 6008 HD dialysis machines with the same machine without the Na management option turned on. Relevant performance and clinical data will be collected as well as information on patients' quality of life and wellbeing. conditions: End Stage Renal Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Prospective, open, controlled, parallel, randomized, interventional, multi-center, explorative primaryPurpose: TREATMENT masking: NONE count: 130 type: ESTIMATED name: Hemodialysis or Hemodiafiltration either with sodium zero-diffusive treatment or standard treatment without sodium-control measure: Interdialytic weight gain measure: Intradialytic hemodynamic stability measure: Intradialytic hemodynamic stability measure: Intradialytic morbid events measure: Fluid status measure: Fluid status measure: PRO: Thirst feeling measure: PRO: Thirst feeling measure: PRO: Fatigue measure: PRO: Hypotensive episodes measure: PRO: HRQOL measure: PRO: Health status sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06341439 id: Prot. 001_2023 briefTitle: Clinical Efficacy of Mouthrinses Based on Chlorhexidine 0.12% and CITROX® overallStatus: ACTIVE_NOT_RECRUITING date: 2023-02-18 date: 2024-01-18 date: 2024-03-30 date: 2024-04-02 date: 2024-04-02 name: University of L'Aquila class: OTHER briefSummary: The goal of the following clinical trial is to compare the efficacy of a product based on chlorhexidine 0.12% and CITROX and the same product without CITROX in the healing phenomena that occur after non-surgical periodontal therapy. The main questions it aims to answer are:
* Is the response to periodontal therapy better if mouthwash containing Citrox is used?
* What is the patients' perception?
Participants, divided into 2 groups, are asked to use either one or the other mouthwash for 14 days after non-surgical periodontal therapy. conditions: Periodontitis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 40 type: ACTUAL name: Mouthwash with chlorhexidine 0,12% and CITROX name: Mouthwash with chlorhexidine 0,12% measure: Probing Depth (PD) measure: Gingival Index (GI) measure: Plaque Index (PI) measure: Full mouth plaque score (FMPS) measure: Full mouth bleeding score (FMBS) measure: Patient Reported Outcome Measure (PROMS) sex: ALL minimumAge: 25 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of L'Aquila, division of periodontology city: L'Aquila zip: 67100 country: Italy lat: 42.35055 lon: 13.39954 hasResults: False
<\|newrecord\|> nctId: NCT06341426 id: 23-5872 briefTitle: Psilocybin-Assisted Psychotherapy for Treatment-Resistant Depression: Comparing One Versus Two Doses of Psilocybin acronym: PSI-1V2 overallStatus: RECRUITING date: 2024-02-05 date: 2028-02-01 date: 2028-08-01 date: 2024-04-02 date: 2024-04-02 name: University Health Network, Toronto class: OTHER name: Centre for Addiction and Mental Health briefSummary: The purpose of this study is to see if one or two doses of psilocybin is more effective in relieving depressive symptoms in patients with treatment-resistant depression (TRD). Researchers also want to know if a second dose of psilocybin is safe and well-tolerated. This study will see if psilocybin is effective, safe, and well-tolerated by tracking changes in depressive symptoms, suicidality, and side effects. This study will also see if a second dose of psilocybin has an effect on quality of life, functioning, cognition (thinking, reasoning, remembering), and how long depressive symptoms improve (or worsen) after psilocybin is administered. conditions: Major Depressive Disorder conditions: Depression conditions: Treatment-Resistant Depression conditions: Mood Disorders studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants will be randomized to two groups for the first dosing session in a 1:1 allocation: 1) non-psychedelic/placebo dose (psilocybin 1mg) or 2) psychedelic dose (psilocybin 25mg). All participants will receive a psychedelic dose (psilocybin 25mg) for their second dosing session. primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: The first dose will be randomized and blinded (1mg psilocybin versus 25mg psilocybin), while the second dose will be open-label (25mg psilocybin). whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 92 type: ESTIMATED name: Single Psychedelic Dose Psilocybin name: Two Psychedelic Doses Psilocybin measure: Antidepressant Efficacy measure: Self-Reported Depression Symptoms measure: Anxiety Symptoms measure: Self-Reported Quality of Life measure: Subjective Functioning measure: Incidence of Treatment Emergent Adverse Events (Safety and Tolerability) measure: Cognitive Dysfunction measure: Psychomotor Performance measure: Phonemic Word Fluency measure: Psychomotor Speed, Visual search, and Attention measure: Verbal Learning and Memory measure: Working Memory, Attention and Executive Function measure: Effort-Based Decision Making measure: Participant Blinding Success measure: Expectancy Effects measure: Quality of Clinician-Patient Therapeutic Relationship measure: Qualitative Narrative Feedback measure: Percentage Restarting Antidepressants measure: EEG Predictors of Response sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Toronto Western Hospital status: RECRUITING city: Toronto state: Ontario zip: M5T 2S8 country: Canada name: Danica Johnson, BScH role: CONTACT email: danica.johnson@uhn.ca name: Zoe Doyle, RN role: CONTACT email: zoe.doyle@uhn.ca name: Joshua Rosenblat, MD, MSc role: PRINCIPAL_INVESTIGATOR lat: 43.70011 lon: -79.4163 hasResults: False
<\|newrecord\|> nctId: NCT06341413 id: 2023-1281 id: A539500 type: OTHER domain: UW- Madison id: SMPH/SLEEP CENTER/SLEEP CTR type: OTHER domain: UW- Madison id: Protocol version 1/17/2024 type: OTHER domain: UW- Madison id: 1R01MH132221 type: NIH link: https://reporter.nih.gov/quickSearch/1R01MH132221 briefTitle: Sleep and Emotion Processing in Adolescent Post-traumatic Stress Disorder overallStatus: NOT_YET_RECRUITING date: 2024-07 date: 2024-10 date: 2024-10 date: 2024-04-02 date: 2024-04-24 name: University of Wisconsin, Madison class: OTHER name: National Institute of Mental Health (NIMH) briefSummary: The goal of this clinical trial is to characterize the role of sleep, emotion processing, and daily affect in post-traumatic stress disorder (PTSD) and whether improving sleep quality using slow wave activity enhancement will impact next-day affect in youth.
Participants will attend 4 study visits:
* A clinical and trauma assessment visit
* A testing day that may include cognitive testing, surveys, and an MRI.
* An overnight sleep study following one week of at-home sleep recordings with the device in the sham condition
* An overnight sleep study following one week of at-home sleep recordings with the device in the sleep enhancement condition conditions: Post Traumatic Stress Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 180 type: ESTIMATED name: SmartSleep device measure: Change in Emotional Regulation - arousal measure: Change in Emotional Regulation - recall measure: Change in Slow-wave Activity (SWA) measure: Change in Positive and Negative Affect Schedule (PANAS) sex: ALL minimumAge: 15 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: University of Wisconsin city: Madison state: Wisconsin zip: 53705 country: United States name: Sara Heyn, JD, PhD role: CONTACT phone: 303-296-2116 email: sheyn@wisc.edu name: Stephanie Jones, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 43.07305 lon: -89.40123 hasResults: False
<\|newrecord\|> nctId: NCT06341400 id: 2024-KY-030-01 briefTitle: RC48 Combined With Toripalimab as Neoadjuvant Therapy for Cisplatin Ineligible MIBC Patients overallStatus: RECRUITING date: 2024-05-20 date: 2026-05-01 date: 2027-05-01 date: 2024-04-02 date: 2024-04-02 name: Zhujiang Hospital class: OTHER briefSummary: A single-arm, prospective, exploratory clinical trial to explore the pathological complete response (pCR) rate of immune checkpoint inhibitors combined with antibody conjugate drugs as the perioperative treatment of platinum-intolerant bladder cancer patients. Fifty-five patients with clinically or pathologically confirmed muscle-invasive bladder urothelial carcinoma (MIBC) who were ineligible for cisplatin-based chemotherapy or refused cisplatin-based chemotherapy were enrolled. Each subject will receive RC48-ADC and toripalimab intravenously every 2 weeks for a total of 4 cycles before surgery, 8 cycles after surgery. The efficacy was evaluated and followed up after 4 cycles of neoadjuvant therapy, 3 months postoperative, and every 3-6 months thereafter. The primary endpoint of this study was pathological complete response rate (pCR). The secondary endpoints were to explore the safety, disease-free survival (DFS), overall survival (OS), objective response rate (ORR) and disease control rate (DCR) of RC48 combined with toripalimab neoadjuvant therapy followed by radical cystectomy. conditions: Bladder Cancer conditions: Muscle-Invasive Bladder Carcinoma studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 55 type: ESTIMATED name: DisitamabVedotinForIicction Toripalimab measure: PcR sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Zhujiang Hospital, Southern Medical University status: RECRUITING city: Guangzhou state: Guangdong country: China name: Peng Xu, doctor role: CONTACT phone: 18665073650 lat: 23.11667 lon: 113.25 hasResults: False
<\|newrecord\|> nctId: NCT06341387 id: R178522-ieo1906 briefTitle: Volatolomic and Proteomic Profile for Early Diagnosis of Lung Cancer overallStatus: RECRUITING date: 2023-05-05 date: 2024-05-30 date: 2024-07-31 date: 2024-04-02 date: 2024-04-02 name: European Institute of Oncology class: OTHER name: University of Rome Tor Vergata briefSummary: The goal of this prospective, case-control study is to discover the specific "omics" biomarkers of early stage of lung cancer using the non-invasive samples (breath, urine and serum) in a total of 200 subjects (100 healthy controls and 100 lung cancer patient). The main questions it aims to answer are:
* Which are the "omics" biomarkers that characterize the early stage of lung cancer?
* How to Translate Laboratory Data into Clinical Data?
For each participant we will collected the breath, urine and blood samples. In lung cancer patients group the samples will be sample before lung cancer resection. The samples of Breath, urine and serum will be analysed using different type of analysis: eNose and the Gas Chromatography combined with Ion Mass Spectrometry (GC/IMS). Moreover, Serum will be analyzed by mass-spectrometry-based proteomics. The purpose of these analyses will be to find biomarkers capable of distinguishing the early-stage of lung cancer from the healthy group. Followup will be performed to evaluate the possible change of the volatolomic and proteomic profile. conditions: Lung Cancer conditions: Non-small Cell Lung Cancer Stage I conditions: Non-small Cell Lung Cancer Stage II conditions: Lung Cancer Diagnosis studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 200 type: ESTIMATED name: Breath, urine and blood analysis measure: Comparison of the proteomic and volatolomic signature in samples of respiratory exhalation, serum, and urine from patients with lung cancer (stage I/II) and healthy individuals at high risk. measure: Omics-Data intagration. sex: ALL minimumAge: 50 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Europen insitute of Oncology- Division of Thoracic Surgery status: RECRUITING city: Milan zip: 20141 country: Italy name: Roberto Gasparri, MD, PhD role: CONTACT phone: 0257489499 email: roberto.gasparri@ieo.it lat: 45.46427 lon: 9.18951 hasResults: False
<\|newrecord\|> nctId: NCT06341374 id: 2023/5079 briefTitle: Impact of Sleep Disorders on Innate Immunity in COVID-19 Patients overallStatus: RECRUITING date: 2023-11-06 date: 2024-03-30 date: 2024-09-30 date: 2024-04-02 date: 2024-04-02 name: Parc Taulí Hospital Universitari class: OTHER briefSummary: Sleep is an important modulator of the immune response, whereby sleep disturbances (ie, poor sleep quality, insufficient sleep and/or primary sleep disorder, obstructive sleep apnea (OSA)) contribute to inflammatory disease risk and dysregulation of immune response in front of infectious agents.
The objective of this study is to evaluate the impact of undiagnosed and non-treated sleep disorders on innate immunity in a cohort of COVID-19 patients and the role of trained immunity induced by influenza vaccination in the innate immune response. conditions: Apnea, Obstructive Sleep conditions: SARS CoV 2 Infection studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 50 type: ESTIMATED name: Influvac Tetra measure: Immunological study: cytokines. measure: Innate cells: monocytes, classical dendritic cells and Natural Killer cells. measure: Epigenetic modification. measure: Diagnostic of obstructive sleep apnea in selected cohort sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital Universitari Parc Tauli status: RECRUITING city: Sabadell state: Barcelona zip: 08208 country: Spain name: Andrea F Grau, Medicine role: CONTACT phone: +34608151458 email: andreagrau94@gmail.com name: Miguel D Gallego, Medicine role: CONTACT phone: +34616315290 email: mgallego@tauli.cat lat: 41.54329 lon: 2.10942 hasResults: False
<\|newrecord\|> nctId: NCT06341361 id: OCT-FFR briefTitle: OCT-based Machine Learning FFR for Predicting Post-PCI FFR overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2024-04-30 date: 2025-10-15 date: 2024-04-02 date: 2024-04-02 name: Yonsei University class: OTHER name: Gangnam Severance Hospital name: Severance Hospital briefSummary: This study aims to compare the diagnostic accuracy of the fractional flow reserve (FFR) model derived by machine learning based on optical coherence tomography (OCT) exam after coronary artery stent implantation with the wire-based FFR. conditions: Tomography, Optical Coherence conditions: Fractional Flow Reserve, Myocardial studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 82 type: ESTIMATED name: OCT-based machine learning FFR measure: Correlation of OCT-based machine learning FFR compared to wire-based FFR measure: Diagnostic performance of OCT-based machine learning FFR compared to wire-based FFR measure: Diagnostic performance of OCT-based machine learning FFR according to the coronary artery (LAD, LCx or RCA) compared to wire-based FFR sex: ALL minimumAge: 19 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06341348 id: Dalin Tzuchi Hospital briefTitle: Effects of Case Management for Patients With Rheumatoid Arthritis in Taiwan overallStatus: COMPLETED date: 2016-01-01 date: 2018-06-30 date: 2018-12-31 date: 2024-04-02 date: 2024-04-02 name: Dalin Tzu Chi General Hospital class: OTHER briefSummary: Case management (CM) has been recommended as a way of inspiring measurable changes in individual behaviors and improving clinical outcomes for patients with chronic diseases. However, data on its effectiveness for Taiwanese patients with rheumatoid arthritis (RA) are limited. This study aimed to determine the long-term effectiveness of CM that focused on nurses' role among Taiwanese RA patients.
A quasi-experimental pre-post test, control-group study with purposive sampling recruited RA patients from a hospital in Taiwan during 2016-2017. CM program was composed of health education sessions and follow-up telephone consultations over a six-month period. A review of medical records and structured questionnaires yielded data about patient demographics and disease characteristics, and included Chinese version of the Arthritis Self-Efficacy Scale and the Taiwanese Depression Questionnaire. A comparison of the long-term effectiveness of the CM program was made using generalized estimating equation.
This evidence-based study may be beneficial to characterize the long-term effectiveness of CM for Taiwanese patients with RA, and may be a reference for healthcare providers in facilitating the provision of appropriate interventions to improve the adaptation processes and clinical outcomes for them. conditions: Case Management conditions: Rheumatoid Arthritis conditions: Effectiveness studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE maskingDescription: A trained interviewer, who was blind with the study design and participants, was assigned to collect the participants' information on demographic and disease characteristics. count: 96 type: ACTUAL name: Case management measure: Depressive symptoms measure: Self-efficacy level measure: Sexual dysfunctionform-14 measure: DAS28 sex: ALL minimumAge: 20 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06341335 id: AK109-301 briefTitle: A Study of AK104/Placebo Plus AK109/Placebo And Paclitaxel in Gastric or Gastroesophageal Junction Adenocarcinoma overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-11 date: 2027-07 date: 2024-04-02 date: 2024-04-02 name: Akeso class: INDUSTRY briefSummary: This randomized, multicenter, double-blind, phase 3 study will evaluate the efficacy and safety of the combination of cadonilimab (AK104) and pulocimab (AK109) and paclitaxel compared with paclitaxel in patients with advanced gastric or gastroesophageal junction adenocarcinoma who failed first-line immunochemotherapy. conditions: Gastric and Gastroesophageal Junction Adenocarcinoma studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 506 type: ESTIMATED name: cadonilimab name: pulocimab name: paclitaxel name: placebo measure: Progression-free survival (PFS) assessed by blinded independent central review (BICR) measure: Overall survival (OS) measure: Progression-free survival (PFS) assessed by investigator measure: Objective Response Rate (ORR) measure: Duration of Response (DoR) measure: Disease control rate (DCR) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06341322 id: ERC0003996 briefTitle: Using Behavioural and Cultural Insights to Increase Colorectal Cancer Home-testing in Croatia overallStatus: RECRUITING date: 2024-03-05 date: 2024-04 date: 2024-07 date: 2024-04-02 date: 2024-04-02 name: Veerle Snijders class: OTHER name: Croatian Institute of Public Health name: Andrija Štampar School of Public Health briefSummary: Colorectal cancer (CRC) is one of the leading causes of death in Croatia. An average of 3600 cases are diagnosed and an average of 2100 people die from the disease every year. Since 2007, Croatia has invited every man and woman aged 50-74 to participate in the home testing screening programme every two years. Currently only around 36% of the invited request the test-kit and 25% complete the home testing procedure, far below the target of 40-60%.
The Croatian Institute of Public Health with technical support from World Health Organization (WHO) Regional Office for Europe is undertaking a mixed-methods research study with the aim to increase the completion of colorectal cancer home testing and improve our knowledge of the barriers and drivers to do so. The study has a quantitative and a qualitative component:
1. Quantitative: testing the introduction of a reminder letter to encourage people to respond to the initial invite to participate in the CRC home test program and test which elements of a reminder letter improve response rates.
The quantitative component consists of a four-arm reminder letter randomized controlled trial (RCT) comparing no letter, standard letter, behaviorally informed letter, and behaviorally informed letter sent with a home testing kit to investigate the effectiveness of reminders in increasing uptake of home-testing for colorectal cancer. Recruitment and data collection for the reminder letter trial will be conducted utilizing the routine screening process and routinely collected screening data.
2. Qualitative: conducting in-depth interviews with people from the target population who did or did not respond to the CRC invite letter and reminder to better understand the barriers and drivers to participation.
The qualitative component consists of 24 in-depth interviews (IDIs) conducted with members of the target population to identify barriers and drivers to completing colorectal cancer screening home-testing. Data collection for IDIs will be face-to-face, using discussion guides, and will be audio recorded. The audio-recordings will then be analyzed using a rapid analysis approach based on by the modified Capability-Opportunity-Motivation-Behavior (COM-B) framework. conditions: Colorectal Cancer conditions: Behavior Change studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants will be randomized to either control (no reminder screening invitation) or one of three treatments (standard reminder letter, behaviorally informed reminder letter, behaviorally informed letter with home testing kit included). primaryPurpose: SCREENING masking: SINGLE whoMasked: PARTICIPANT count: 13000 type: ESTIMATED name: Standard letter name: Behaviorally informed letter name: Home testing colorectal cancer kit measure: Home test kit ordered measure: Completed colorectal cancer screening measure: Opted out measure: Qualitative feedback sex: ALL minimumAge: 50 Years maximumAge: 74 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Croatian Institute of Public Health status: RECRUITING city: Zagreb country: Croatia name: Ivana Brkić Biloš, MD role: CONTACT email: ivana.brkic@hzjz.hr name: Nataša Antoljak, Prof role: CONTACT email: natasa.antoljak@hzjz.hr lat: 45.81444 lon: 15.97798 hasResults: False
<\|newrecord\|> nctId: NCT06341309 id: CSPC-DEY-CRC-K09 briefTitle: Exploratory Study of Irinotecan Liposomes in Maintenance Therapy of Metastatic Colorectal Cancer overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-04-01 date: 2026-08-01 date: 2024-04-02 date: 2024-04-02 name: West China Hospital class: OTHER briefSummary: To evaluate the progression-free survival (PFS1), objective response rate (ORR), disease control rate (DCR), progression-free survival from first-line treatment initiation (PFS2), overall survival (OS), and safety of irinotecan liposome combined with bevacizumab in patients with advanced metastatic colorectal cancer. conditions: Metastatic Colorectal Cancer studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: Irinotecan Liposome name: Bevacizumab measure: Progression free survival -1 measure: Progression free survival -2 measure: Objective response rate measure: Disease control rate measure: Overall survival measure: Incidence of adverse events and severity of adverse events as assessed by CTCAE 5.0 sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06341296 id: CSPC-DEY-CRC-K07 briefTitle: Phase II Study of Irinotecan Liposomes in First-line Treatment of Metastatic Colorectal Cancer overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-04 date: 2026-12 date: 2024-04-02 date: 2024-04-02 name: West China Hospital class: OTHER briefSummary: To evaluate the objective response rate, disease control rate, progression-free survival, overall survival, surgical conversion rate and safety of irinotecan liposome combined with 5-FU/LV+ bevacizumab regimen in first-line treatment of advanced metastatic colorectal cancer patients. conditions: Metastatic Colorectal Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 86 type: ESTIMATED name: Irinotecan Liposome name: 5-FU name: LV name: Bevacizumab measure: Objective response rate measure: Disease control rate measure: Progression free survival measure: Overall survival measure: Percentage of patients undergoing surgery. measure: R0 resection measure: Incidence of adverse events and severity of adverse events as assessed by CTCAE 5.0 sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

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