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Participants receive treatment and will complete questionnaires. The study is conducted in two phases. Its aim is to compare two different trauma-focused treatments (EMDR and PE) for patients with PTSD to one another and with a nontrauma-focused psychotherapy (IPT) and to investigate possible predictors and moderators for treatment success. Patients will first be randomized to PE or EMDR in the first treatment phase. After this first phase, non-responders are re-randomized for a second phase of treatment. They receive either the alternative phase 1 trauma-focused psychotherapy or IPT as non-trauma-focused therapy. In phase 1 researchers will compare the PE and EMDR group to see which treatment is most effective for whom. In phase 2 researchers will compare the trauma-focused treatments (PE and EMDR group) with the nontrauma-focused treatment (IPT group) to see which treatment is most effective for whom. conditions: Stress Disorders, Post-Traumatic studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The study is a randomized controlled trial (RCT) conducted in two phases. Patients with PTSD will first be randomized to PE or EMDR in the first treatment phase. After this first phase of treatment, non-responders are re-randomized for a second phase of treatment. They receive either the alternative phase 1 trauma-focused psychotherapy or IPT as non-trauma-focused therapy for PTSD. In both phases (phase 1 and 2) the treatment lasts 8 weeks. Patients receive 14 sessions of 1 hour in 8 weeks. primaryPurpose: TREATMENT masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 442 type: ESTIMATED name: Prolonged Exposure therapy name: Eye Movement Desensitization Reprocessing (EMDR) name: Interpersonal Psychotherapy (IPT) measure: PTSD Checklist for DSM-5 (PCL-5) measure: Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) measure: International Trauma Questionnaire (ITQ) measure: Hospital Anxiety and Depression Scale (HADS) measure: Mental Health Continuum Short Form (MHC-SF) measure: Positive and Negative Experiences of Psychotherapy questionnaire (PNEP) measure: Age measure: Gender measure: Education measure: Employment measure: Marital status measure: Ethnicity/race measure: Medication use measure: Treatment history measure: Mini-Schedules for Clinical Assessment in Neuropsychiatry (mini-SCAN) measure: Life Events Checklist for DSM-5 (LEC-5) measure: The Childhood Trauma Questionnaire-Short Form (CTQ-SF) measure: Symptom Checklist-90 (SCL-90), Hostility subscale measure: Experiences in Close Relationships-Relationship Structures (ECR-RS) measure: The Brief Experiental Avoidance Questionnaire (BEAQ) measure: Improving Access to Psychological Therapies (IAPT) measure: Posttraumatic Cognitions Inventory (PTCI) measure: Trauma Related Guilt Inventory (TRGI) measure: Trauma Related Shame Iventory (TRSI) measure: Working Alliance Questionnaire shortened version (WAV-12) measure: Expectancy rating (patients and therapists) sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Dimence status: RECRUITING city: Deventer country: Netherlands name: Maarten K van Dijk, PhD role: CONTACT phone: +31 0570-604000 email: m.vandijk@dimence.nl name: Dominique Jonkers, Master role: CONTACT phone: +31 038-4692300 email: d.jonkers@dimence.nl lat: 52.255 lon: 6.16389 hasResults: False
<|newrecord|> nctId: NCT06279585 id: ECA GVHD briefTitle: Physical Therapy in Patients Undergoing Allo-HSCT With cGVHD overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-12 date: 2025-09 date: 2024-02-28 date: 2024-02-28 name: University of Seville class: OTHER briefSummary: Allogeneic Hematopoietic Stem Cell Transplantation (alloHSCT) represents the only curative option for many patients diagnosed with various hematologic neoplasms. Procedure-related morbidity and mortality pose challenges to long-term outcomes and quality of life, especially among patients who develop chronic graft-versus-host disease (cGVHD). There is a gap in healthcare that comprehensively addresses the specific needs of these patients. Physical therapy as an adjuvant treatment, through therapeutic exercise involving muscle strength and cardiorespiratory endurance, has shown positive influences on health markers and serves as a strong medical ally in similar profiles. Although these strategies could be reproducible and potentially beneficial for cGVHD patients, research has been limited to date, with the role of physical therapy possibly underutilized in this field. Justification: Unaddressed medical gap with no rigorously scientific responses specific to cGVHD. Objectives: This project aims to conduct the first randomized clinical trial from a physical therapy perspective as an adjuvant treatment for patients undergoing alloHSCT diagnosed with cGVHD. conditions: Graft-versus-host-disease conditions: Graft Versus Host Disease, Chronic conditions: Stem Cell Transplant Complications conditions: Hematological Malignancy conditions: Hematologic Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 108 type: ESTIMATED name: Physical therapy measure: Health-related quality of life measure: Chronic Graft-Versus-Host Disease (cGVHD) symptom burden measure: Muscular strength measure: Cardiorespiratory fitness measure: Functional status measure: Distress measure: Mood measure: Anxiety measure: Biological markers measure: Responses to medical treatment sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Seville; Manuel Siurot Avenue, no number city: Seville zip: 41013 country: Spain name: Raquel P Aguilar, Ph.D.cand. role: CONTACT phone: 955 013 260 phoneExt: 34 email: raquelijorml@gmail.com name: José Antonio P Simón, PhD role: CONTACT phone: 955 013 260 phoneExt: 34 email: josea.perez.simon.sspa@juntadeandalucia.es lat: 37.38283 lon: -5.97317 hasResults: False
<|newrecord|> nctId: NCT06279572 id: 20-011624 id: NCI-2022-09618 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: 20-011624 type: OTHER domain: Mayo Clinic Institutional Review Board briefTitle: Immune Profile of Acute Myeloid Leukemia Patients Receiving Azacitidine Plus Venetoclax Induction Chemotherapy overallStatus: RECRUITING date: 2021-04-22 date: 2025-12-31 date: 2026-12-31 date: 2024-02-28 date: 2024-02-28 name: Mayo Clinic class: OTHER briefSummary: This study investigates the immune profile of patients receiving treatment with venetoclax plus azacitidine for acute myeloid leukemia (AML). Studying the information gathered from the immune profile from blood and bone marrow samples may help researchers understand the associated responses to the treatment of patients undergoing therapy of venetoclax plus azacitidine and create future immune based treatment approaches. conditions: Acute Myeloid Leukemia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 80 type: ESTIMATED name: Biospecimen Collection name: Bone Marrow Aspirate name: Electronic Health Record Review measure: Immune profile of treatment naive acute myeloid leukemia (AML) patients receiving azacitidine plus venetoclax chemotherapy sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mayo Clinic in Arizona status: NOT_YET_RECRUITING city: Scottsdale state: Arizona zip: 85259 country: United States name: Clinical Trials Referral Office role: CONTACT phone: 855-776-0015 email: mayocliniccancerstudies@mayo.edu name: Cecilia Y. Arana Yi, M.D. role: PRINCIPAL_INVESTIGATOR lat: 33.50921 lon: -111.89903 facility: Mayo Clinic in Florida status: RECRUITING city: Jacksonville state: Florida zip: 32224-9980 country: United States name: Clinical Trials Referral Office role: CONTACT phone: 855-776-0015 email: mayocliniccancerstudies@mayo.edu name: Talha Badar, M.D. role: PRINCIPAL_INVESTIGATOR lat: 30.33218 lon: -81.65565 facility: Mayo Clinic in Rochester status: NOT_YET_RECRUITING city: Rochester state: Minnesota zip: 55905 country: United States name: Clinical Trials Referral Office role: CONTACT phone: 855-776-0015 email: mayocliniccancerstudies@mayo.edu name: Mithun V. Shah, M.D., Ph.D. role: PRINCIPAL_INVESTIGATOR lat: 44.02163 lon: -92.4699 hasResults: False
<|newrecord|> nctId: NCT06279559 id: MTinHRP_v1_10/01/2023 briefTitle: Music Therapy and High-risk Pregnancy overallStatus: RECRUITING date: 2023-06-01 date: 2024-12-01 date: 2024-12-01 date: 2024-02-28 date: 2024-02-28 name: Istituto Giannina Gaslini class: OTHER briefSummary: The objective of this clinical trial is to assess the impact of a music therapy intervention on reactive psychological components related to the risk of preterm birth in hospitalized pregnant women. The primary inquiries it seeks to address are:
1. Can a music therapy intervention during high-risk pregnancy mitigate reactive psychological components (perceived emotional state, state anxiety and trait anxiety, depressive symptoms, perceived stress) related to the risk of preterm birth in hospitalized pregnant women?
2. Does music therapy intervention during high-risk pregnancy positively influence the development of the attachment bond between the mother and the child?
3. How does the risk of preterm birth modulate the future attachment bond between mother and child?
Participants will be categorized into three groups: a clinical experimental group (pregnant women at risk of preterm birth undergoing music therapy intervention), a clinical control group (pregnant women at risk of preterm birth receiving standard ward care), and a non-clinical control group (pregnant women with a physiologically progressing pregnancy).
Upon signing the informed consent, all three groups will be required to complete five self-report questionnaires assessing perceived positive and negative feelings, depressive symptoms, state anxiety and trait anxiety, perceived stress, and the mother-fetus attachment bond. Subsequently, the clinical experimental group will undergo ten online music therapy sessions, while the clinical control group will receive routine ward care. Following the music therapy sessions, both clinical groups will reassess the aforementioned measures. The non-clinical control group will complete the same self-report questionnaires with the same timing as the clinical groups. All three groups will be contacted three months after childbirth to complete a self-report questionnaire evaluating the postnatal attachment bond.
Researchers will compare the outcomes of the two clinical groups to address the first two research questions, while the comparison between the clinical control group and the non-clinical control group outcomes will be employed to answer the third research question. conditions: High Risk Pregnancy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 72 type: ESTIMATED name: Music-therapy measure: Depressive symptoms measure: State anxiety and trait anxiety measure: Perceived stress measure: Perceived positive and negative feelings measure: Mother-fetus attachment bond measure: Mother-child attachment bond sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Istituto Giannina Gaslini status: RECRUITING city: Genova zip: 16147 country: Italy name: Cristina Venturino role: CONTACT phone: 010 5636.2346 email: cristinaventurino@gaslini.org lat: 44.40478 lon: 8.94438 hasResults: False
<|newrecord|> nctId: NCT06279546 id: IECED-12345 briefTitle: Artificial Intelligence vs Endoscopist Identification in EUS Normal Anatomy overallStatus: COMPLETED date: 2023-05-01 date: 2023-10-01 date: 2024-01-26 date: 2024-02-28 date: 2024-02-28 name: Instituto Ecuatoriano de Enfermedades Digestivas class: OTHER name: The Methodist Hospital Research Institute name: Baylor Saint Luke's Medical Center name: Beth Israel Deaconess Medical Center name: Barra Life Medical Center, Brazil name: Hospital Clinico Universitario de Santiago name: Universitair Ziekenhuis Brussel name: Hospital Civil de Morelia, Michoacan name: ELIAS Emergency University Hospital name: Larkin Community Hospital name: Carol Davila University of Medicine and Pharmacy name: mdconsgroup, Guayaquil, Ecuador briefSummary: Endoscopic ultrasound (EUS) visual impression is operator-dependant and can hinder diagnostic accuracy, especially in less experienced endoscopists. The implementation of artificial intelligence can potentially mitigate operator dependency and interpretation variability, helping or improving the overall accuracy.
The investigators therefore aim to compare diagnostic accuracy between artificial intelligence (AI)-based model and the endoscopists when identifying normal anatomical structures in EUS-procedures. conditions: Gastrointestinal Diseases studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 30 type: ACTUAL name: Detection of structures measure: Diagnostic accuracy measure: Interobserver agreement sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IECED city: Guayaquil state: Guayas zip: 090505 country: Ecuador lat: -2.20584 lon: -79.90795 hasResults: False
<|newrecord|> nctId: NCT06279533 id: LV232-02 briefTitle: Safety and Pharmacokinetics Study of Multiple Ascending Doses and Food Effect of LV232 Capsules overallStatus: RECRUITING date: 2024-02-27 date: 2024-07 date: 2024-07 date: 2024-02-28 date: 2024-04-24 name: Vigonvita Life Sciences class: INDUSTRY briefSummary: This study is divided into two parts: the safety, tolerability, pharmacokinetic profiles of LV232 capsules after multiple ascending doses (hereinafter referred to as "PK characteristics of multiple ascending doses study ") and food effect study (hereinafter referred to as "FE study"). A total of 48 subjects are planned to be enrolled. The two parts of the study can be carried out simultaneously, and there is no order requirement. conditions: Healthy Subjects studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: PK characteristics of multiple ascending doses study is parallel design, and FE study is crossover design primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: PK characteristics of multiple ascending doses study is double-blinded, placebo-controlled design, and FE study is open-label design whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 48 type: ESTIMATED name: LV232/Placebo name: LV232 measure: Tmax measure: Cmax measure: T1/2 measure: AUC0-t measure: AUC0-24h measure: AUC0-∞ measure: Number of participants with treatment emergent treatment-related adverse event(s) measure: Laboratory test measure: Vital signs measure: Number of participants with ECG findings of potential clinical importance sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Shanghai Xuhui Central Hospital status: RECRUITING city: Shanghai country: China name: Chen Yu role: CONTACT lat: 31.22222 lon: 121.45806 hasResults: False
<|newrecord|> nctId: NCT06279520 id: 2023-08-003 briefTitle: Driving Ability Evaluation System to Improve the Conditional Driving License System: Safety and Feasibility Study. overallStatus: RECRUITING date: 2024-02-19 date: 2024-12-31 date: 2024-12-31 date: 2024-02-28 date: 2024-02-28 name: Seoul National University Hospital class: OTHER briefSummary: The primary objective of this study is to verify the safety and validity of a VR driving simulator developed for evaluating the driving abilities in healthy adults.
This study also aims to establish indicators in VR driving simulator to evaluate high-risk group for driving, such as cognitive and physical abilities. Therefore, this study aims to measure the physical driving function and cognitive function of healthy drivers. to identify the correlation between their outcomes and the VR driving simulator's result conditions: Automobile Driving studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SCREENING masking: NONE count: 100 type: ESTIMATED name: VR Driving Simulator name: Computerized Neurocognitive Function Test name: Driver Test Station name: On-road field driving Test measure: Feasibility of VR driving simulator measure: Driving performance in simulator, measured by driving errors sex: ALL minimumAge: 19 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Seoul National University Hospital status: RECRUITING city: Seoul country: Korea, Republic of name: Ja-Ho Leigh, M.D. Msc. role: CONTACT email: mazican@gmail.com lat: 37.566 lon: 126.9784 hasResults: False
<|newrecord|> nctId: NCT06279507 id: PMK-00007 briefTitle: Efficacy of Hyaluronic Acid Injection in Knee Osteoarthritis overallStatus: RECRUITING date: 2024-02-10 date: 2025-01-31 date: 2025-06-30 date: 2024-02-28 date: 2024-02-28 name: Phramongkutklao College of Medicine and Hospital class: OTHER name: Chulalongkorn University name: Khon Kaen University name: Police General Hospital briefSummary: The aim of this clinical trial study is to compare the efficacy of Hyaluronic injection in patients with symptomatic knee osteoarthritis. The main questions it aims to answer are:
* Is Hyaluronic acid injection improve pain symptom, joint stiffness, and joint function in patients with knee osteoarthritis
* Is Hyaluronic acid injection improve knee performance status and health-related quality of life in patients with knee osteoarthritis
Participants will be allocated to receive one treatments; either Hyaluronic acid or normal saline injections after receiving glucocorticoid injection.
Researchers will compare the Hyaluronic acid with normal saline injection to see if the former show superior effect in terms of pain, joint stiffness, function, as well as health-related quality of life comparing with placebo. conditions: Knee Osteoarthritis conditions: Pain, Joint conditions: Stiffness of Knee, Not Elsewhere Classified conditions: Quality of Life studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The participants would be allocated into one treatment group;
* Intervention group : Hyaluronic acid injection
* Placebo group : Normal saline primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: Participants will not know what treatment they receive. Co-investigators will not know what the participants are injected. Outcome assessor will not know which treatment participant receive. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 176 type: ESTIMATED name: Sodium Hyaluronate name: Normal Saline name: Triamcinolone Acetonide 10mg/mL measure: Pain outcome measurement measure: Joint stiffness and function measurement measure: Overall symptom assessment measure: Knee performance evaluation measure: Quality of life assessment sex: ALL minimumAge: 50 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Phramongkutklao Hospital status: RECRUITING city: Bangkok zip: 10400 country: Thailand name: Suthee Panichkul role: CONTACT phone: 6623547600 phoneExt: 93681 email: suthee99@yahoo.com lat: 13.75398 lon: 100.50144 hasResults: False
<|newrecord|> nctId: NCT06279494 id: Sirolimus for GVHD prophylaxis briefTitle: Sirolimus+Abatacept+Mycophenolate Mofetil for Prophylaxis of aGVHD in Patients Receiving Haplo-HSCT Who Are Intolerant to Calcineurin Inhibitors overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-06 date: 2025-03 date: 2024-02-28 date: 2024-03-21 name: Peking University People's Hospital class: OTHER briefSummary: Graft-versus-host disease (GVHD) is an important complication after transplantation, with an incidence of 40-60%, which can increase non-relapse mortality if poorly controlled. At present, the standard prophylaxis for GVHD is cyclosporine combined with methotrexate. However, calcineurin inhibitors (CNI) can cause some vital side effects, which are not tolerated by some patients. Therefore, this study aims to explore the safety and efficacy of Sirolimus in combination with Abatacept and Mycophenolate Mofetil for the prophylaxis of GVHD in patients with haplo-HSCT who are intolerant to calcineurin inhibitors. conditions: Acute Leukemia conditions: Myelodysplastic Syndromes conditions: Severe Aplastic Anemia studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: PREVENTION masking: NONE count: 6 type: ESTIMATED name: Sirolimus name: Abatacept name: MMF name: ATG measure: Incidence of Grade 2-4 aGVHD within 100 days post transplantation measure: Incidence of chronic GVHD (cGVHD) within 1 year post transplantation measure: Incidence of thrombotic microangiopathy within 1 year post transplantation measure: Cumulative incidence of relapse measure: Transplant-related mortality measure: Overall survival measure: Incidence of cytomegalovirus (CMV) and Epstein-Barr virus (EBV) sex: ALL minimumAge: 14 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<|newrecord|> nctId: NCT06279481 id: PUMCH-K2458 briefTitle: Effect of Virtual Reality (VR) on Pain Relieve During Colonoscopy overallStatus: RECRUITING date: 2024-03 date: 2024-12 date: 2024-12 date: 2024-02-28 date: 2024-02-28 name: Peking Union Medical College Hospital class: OTHER briefSummary: Purpose: To evaluate the effectiveness and safety of virtual reality (VR) technology in alleviating pain during colonoscopy.
Design and Methods: In the context of a single-centered, prospective, randomized controlled study, the pain levels experienced during colonoscopy are compared between the VR group and the control group. conditions: Pain conditions: Colonoscopy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: a single-centered, prospective, randomized controlled study primaryPurpose: TREATMENT masking: NONE count: 98 type: ESTIMATED name: Nonpharmacological method measure: Comparison of Visual Analogue Scale Mean Scores by Groups measure: Comparison of State Trait Anxiety Inventory Mean Scores by Groups measure: Comparison of Vital Signs between Groups: Pulse Rate measure: Comparison of Vital Signs between Groups: Blood Pressure measure: Comparison of Vital Signs between Groups: Respiration Rate measure: Comparison of Vital Signs between Groups: Oxygen Saturation measure: Comparison of Patient Satisfaction of Colonoscopy between Groups measure: Comparison of Patient Willingness of Future Colonoscopy between Groups measure: Comparison of Adverse Effects in both groups sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Peking Union Medical College Hospital, Chinese Academy of Medical Sciences status: RECRUITING city: Beijing state: Beijing zip: 100010 country: China lat: 39.9075 lon: 116.39723 hasResults: False
<|newrecord|> nctId: NCT06279468 id: I-23PJ2232 briefTitle: Clinical Effectiveness of Intervertebral Disc Release in Treating Lenke 5 Adolescent Idiopathic Scoliosis overallStatus: RECRUITING date: 2024-01-01 date: 2026-06-01 date: 2026-06-01 date: 2024-02-28 date: 2024-02-28 name: Peking Union Medical College Hospital class: OTHER briefSummary: Adolescent idiopathic scoliosis (AIS) poses challenges in achieving optimal three-dimensional correction. While posterior fusion with pedicle screws has shown success, osteotomy techniques, such as Ponte osteotomy, have further improved outcomes. However, residual vertebral rotation remains a concern, impacting long-term complications. Intervertebral disc release (IDR) presents a potential solution to enhance derotation and reduce fusion levels, particularly in Lenke Type 5 AIS. This prospective randomized controlled trial aims to evaluate the clinical effectiveness of IDR in treating Lenke 5 AIS, comparing it to Ponte osteotomy. The study focuses on axial vertebral rotation correction, coronal curve improvement, blood loss, hospital stay, and adverse events. Participants aged 10-18 with Lenke 5 AIS will undergo either IDR or Ponte osteotomy, randomly assigned. Outcome measures include axial rotation correction rate, radiographic parameters, and clinical assessments. A total of 132 participants will be recruited. The IDR technique, through posterior disc removal, presents a promising approach to optimize derotation in Lenke 5 AIS. While offering potential advantages, challenges like limited working space and bleeding risks require careful consideration. The study's findings aim to provide robust clinical evidence, enhancing treatment strategies for Lenke 5 AIS and offering innovative approaches for AIS as a whole. conditions: Adolescent Idiopathic Scoliosis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 132 type: ESTIMATED name: intervertebral disc release name: Ponte osteotomy measure: The correction rate of axial rotation of the apex vertebrae measure: Lumbar curve measure: UIV tilt measure: C7-CSVL measure: Lumbar lordosis measure: SVA measure: Radiographic parameters measured by CT scan: LIV and LIV+1 translation measure: LIV tilt measure: The lowest instrumented vertebra disc angle measure: Age measure: Gender measure: Risser grade of the patients at the time of surgery measure: number of fused spinal levels measure: length of operation measure: Scoliosis Research Society-22,SRS-22 score measure: the MOS item short from health survey, SF-36 score measure: EuroQol Five Dimensions Questionnaire, EQ-5D score measure: Perioperative total blood loss measure: Visible blood loss measure: Perioperative transfusion amounts measure: Perioperative transfusion rates measure: Rate of postoperative infection measure: The incidence of nerve damage measure: The incidence of loss of correction sex: ALL minimumAge: 10 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Peking Union Medical College Hospital status: RECRUITING city: Beijing state: Beijing zip: 100035 country: China name: Qianyu Zhuang, Professor role: CONTACT phone: +86 15200838996 email: baizhuosong@126.com lat: 39.9075 lon: 116.39723 hasResults: False
<|newrecord|> nctId: NCT06279455 id: E-74555795-050.01.04-392120 briefTitle: Pelvic Floor Muscle Exercise During Pregnancy overallStatus: COMPLETED date: 2022-12-05 date: 2023-03-06 date: 2023-10-30 date: 2024-02-28 date: 2024-04-03 name: Istanbul University - Cerrahpasa (IUC) class: OTHER briefSummary: This study was conducted to evaluate the effects of pelvic floor muscle exercises during pregnancy on sexual function, lower urinary tract symptoms and birth process. The research was conducted with pregnant women who applied to the Pregnancy Outpatient Clinic of Istanbul University-Cerrahpasa Cerrahpasa Faculty of Medicine Hospital. Power analysis was performed to determine the number of samples to be included in the study. It was determined that 29 pregnant women should be included in each group (experimental and control). Considering the possibility of data loss, 50 pregnant women were included in each group. As a result of the exclusion of 8 women who withdrew from participating in the study, 5 women due to risky pregnancies (bleeding, preeclampsia and gestational diabetes) and 17 women due to cesarean delivery, the data of 35 pregnant women in the experimental group and 35 pregnant women in the control group were obtained. Pregnant women in the experimental group were gestational aged 18-20. Two sessions of training were given on female reproductive and urinary system anatomy, physiological changes during pregnancy and their effects on sexual life, and pelvic floor muscle exercises, using the "Pelvic Floor Health \& Sexual Life Training Booklet during Pregnancy" and the pelvic floor muscle exercise training video developed by the researcher between the weeks of pregnancy. Pregnant women were asked to perform pelvic floor muscle exercises, 3 sets a day, 3 days a week, for 12 weeks, starting from the 20th week of pregnancy, and record them in the Pelvic Floor Muscle Exercise Follow-up Form created by the researcher. Pregnant women in the control group were not given any training and were routinely monitored in the outpatient clinic. Pregnant women who apply to the outpatient clinic are examined by nurses, with their vital signs taken and anamnesis taken by the physician. Recommendations are made regarding the complaints of pregnant women. Non-stress tests are routinely applied to pregnant women who are at the 36th week of pregnancy and above. conditions: Lower Urinary Tract Symptoms conditions: Sexual Function studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Pelvic Floor Muscle Exercise Group primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 70 type: ACTUAL name: Pelvic Floor Muscle Exercise measure: Sexual Function measure: Lower Urinary Tract Symptoms measure: Birth Process sex: FEMALE minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: Istanbul University-Cerrahpasa city: Istanbul country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False
<|newrecord|> nctId: NCT06279442 id: LACOG 0723 briefTitle: Adrenal Project: Clinical and Epidemiological Characterization of Adrenocortical Carcinoma in a Brazilian Cohort overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2025-08 date: 2025-08 date: 2024-02-28 date: 2024-02-28 name: Latin American Cooperative Oncology Group class: OTHER briefSummary: This is a retrospective observational cohort study. The clinical, pathological and treatment data of participants identified with adrenocortical carcinoma from the year 2000 onwards will be evaluated. Participants recruited for this study will be identified at the participating sites. conditions: Carcinoma Adrenal conditions: Carcinoma, Adrenocortical Recurrent studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 150 type: ESTIMATED measure: Demographic and Clinical Characterization of Adrenocortical Carcinoma in Brazil measure: Assessment of the Association Between Clinical, Pathological, Epidemiological Factors, and Therapeutic Modalities with Prognosis and Outcomes such as Overall Survival or Recurrence-Free Survival measure: Evaluating the Impact of Adjuvant Mitotane Use on Progression-Free Survival and Overall Survival sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: A.C. Camargo Cancer Center city: São Paulo zip: 01.509-001 country: Brazil name: Milena Shizue Tariki role: PRINCIPAL_INVESTIGATOR lat: -23.5475 lon: -46.63611 hasResults: False
<|newrecord|> nctId: NCT06279429 id: KTGH11137 briefTitle: Sucrosomial Iron on Insomnia in Non-dialysis Chronic Kidney Disease Patients With Iron Deficiency Anemia overallStatus: RECRUITING date: 2022-05-31 date: 2024-12-31 date: 2024-12-31 date: 2024-02-28 date: 2024-02-29 name: Kuang Tien General Hospital class: OTHER briefSummary: Insomnia or sleep disturbance is a common disorder in patients with chronic kidney disease (CKD), but is often unrecognized and undertreated. It is known that sleep disorders may indirectly cause a variety of diseases and affect quality of life. The most common sleep disorders that occur in CKD are insomnia, excessive daytime sleepiness, obstructive or central sleep apnea (SA), and sleep disorders. This study evaluates the effectiveness and safety of Sideral® Sucrosomial Iron and iron chewable tablets 100mg commonly used in health insurance on sleep disorders in patients with CKD and iron deficiency anemia. conditions: CKD conditions: Sleep Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 100 type: ESTIMATED name: Sideral® Sucrosomial Iron name: Iron chewable tablet measure: Insomnia Severity Index (ISI) measure: Pittsburgh Sleep Quality Index (PSQI) measure: Epworth sleepiness Scale (ESS) measure: Hemoglobin measure: Ferritin measure: Serum Iron measure: Transferrin Saturation measure: Erythrocyte sedimentation rate sex: ALL minimumAge: 20 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Kuang Tien General Hospital status: RECRUITING city: Taichung zip: 433 country: Taiwan name: Nai-Hwei Wang, MD role: CONTACT phone: 886426885599 email: fengcheese@gmail.com name: Chun-Pai Yang, MD role: PRINCIPAL_INVESTIGATOR lat: 24.1469 lon: 120.6839 hasResults: False
<|newrecord|> nctId: NCT06279416 id: 2023-31 briefTitle: Expected Difficult Airway Management overallStatus: RECRUITING date: 2023-12-30 date: 2024-12 date: 2024-12 date: 2024-02-28 date: 2024-03-08 name: Kocaeli City Hospital class: OTHER_GOV briefSummary: In this study, the investigators will evaluate the advanced airway methods applied in the anesthesiology and reanimation clinic of the hospital to patients who met the criteria for awake intubation specified in the ASA 2022 difficult airway management guideline or who could not be intubated after induction of anesthesia in another center. The advanced airway method applied to the difficult airway patient expected in the operating room, the duration, success and complications of the method will be observed and recorded. conditions: Awake Intubation conditions: Advanced Airway Techniques studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 108 type: ESTIMATED name: fiberoptic intubation name: laryngeal mask airway-mediated aintree catheter name: videolaryngoscopy measure: Comparison of advanced airway methods in the awake patient with difficult airway. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Kocaeli City Hospital status: RECRUITING city: Kocaeli country: Turkey lat: 39.62497 lon: 27.51145 hasResults: False
<|newrecord|> nctId: NCT06279403 id: IIT-2023-0277 briefTitle: Upfront Immune Checkpoint Inhibitors With Deferred Cytoreductive Nephrectomy for Metastatic Renal Cell Carcinoma overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2026-03-01 date: 2029-03-01 date: 2024-02-28 date: 2024-02-28 name: RenJi Hospital class: OTHER briefSummary: Study Objective: To determine the efficacy of upfront immune checkpoint inhibitors combined with deferred cytoreductive nephrectomy in treating metastatic renal cell carcinoma.
Primary Endpoint: Pathological Major Response (MPR), defined as the percentage of residual tumor cells \<10% in the primary tumor after nephrectomy.
Study Design:
Population: Participants meeting the diagnostic criteria with biopsy-proven clear cell renal cell carcinoma, IMDC score ≤3, or ≤5 metastatic lesions involving ≤3 organs.
Sample Size: 20 participants.
Patient Grouping: Non-randomized.
Interventions: Eligible participants will receive upfront treatment with a combination of Axitinib and Toripalimab for 4 cycles. After 2 cycles of treatment, radiological assessment will be conducted using RECIST 1.1 criteria. If disease progression is observed, the clinical trial will be terminated, and second-line treatment will be initiated according to guidelines. If disease progression is not observed, treatment will continue for 2 additional cycles followed by repeat radiological assessment before undergoing surgery. conditions: Clear-cell Metastatic Renal Cell Carcinoma conditions: Immune Checkpoint Inhibitors conditions: Cytoreductive Nephrectomy studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: Toripalimab name: Cytoreductive Nephrectomy name: Axitinib measure: Pathological Major Response (MPR) sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<|newrecord|> nctId: NCT06279390 id: 202305126RINC briefTitle: PRE-DELIRIC Prediction Model Plus SMART Care to Reduce the Incidence of Delirium in ICU Patients overallStatus: COMPLETED date: 2023-06-08 date: 2023-10-30 date: 2023-10-30 date: 2024-02-28 date: 2024-02-28 name: National Taiwan University Hospital class: OTHER briefSummary: Delirium is a severe acute brain dysfunction characterised by sudden confusion, inattention and fluctuating level of consciousness, which mainly affects intubated intensive care patients. It increases the risk of self-extubation, prolongs ICU stay and increases mortality. The incidence of delirium in ICUs varies, with approximately 33.3% of patients affected, and rates of new-onset and pre-existing delirium range from 4% to 89%. Accurate diagnosis is challenging, with 60-80% of patients remaining undiagnosed. Early detection is critical for intervention and improved outcomes.
To address these issues, the PREdiction of DELIRium (PRE-DELIRIC) model incorporates 10 risk factors and predicts delirium within 24 hours of ICU admission, allowing risk stratification into low to very high risk categories. It recalibrates predictive values with a sensitivity of 91.3% and specificity of 64.4% using a cut-off score of 27%. However, its integration into delirium management is underexplored. Delirium risk stratification supports efficient resource allocation, cost control, workload reduction and ethical care, while promptly identifying high-risk patients.
In this study, Investigators evaluate the integration of the PRE-DELIRIC model into a comprehensive delirium management approach called PRE-DELIRIC-guided SMART/SmART care. SMART care includes improving familiarity, assessing pain and anxiety, reducing equipment discomfort and cognitive stimulation. Patients with PRE-DELIRIC scores \>30% receive SMART care and multidisciplinary involvement, based on the American Delirium Society. conditions: Intensive Care Unit Delirium studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 381 type: ACTUAL measure: the incidence of delirium measure: duration of ventilator use measure: rate of unplanned self-extubation measure: day of physical restraint measure: level of mobility measure: cumulative dose of sedatives sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: National Taiwan University Hospital city: Taipei zip: 100 country: Taiwan lat: 25.04776 lon: 121.53185 hasResults: False
<|newrecord|> nctId: NCT06279377 id: Katip Celebi University briefTitle: Examining the Effectiveness of Exercise Training After Cervical Laminoplasty Surgery overallStatus: RECRUITING date: 2023-05-05 date: 2024-09-15 date: 2025-05-15 date: 2024-02-28 date: 2024-02-28 name: Izmir Katip Celebi University class: OTHER briefSummary: The goal of this clinical trial is to compare the effects of the stabilization exercise program applied after cervical laminoplasty surgery compared to standard exercise on pain, dysfunction, normal joint movement, proprioception, balance, muscle endurance, postural alignment and related factors (kinesiophobia, awareness, quality of life, disability, physical activity level). The main question\[s\] it aims to answer are:
* Does the exercise program applied after cervical laminoplasty surgery have an effect on pain, dysfunction, normal joint movement, proprioception, balance, muscle endurance, postural alignment and related factors (kinesiophobia, awareness, quality of life, disability, physical activity level)?
* Does the stabilization exercise program applied after cervical laminoplasty surgery have an effect on pain, dysfunction, normal joint movement, proprioception, balance, muscle endurance, postural alignment and related factors (kinesiophobia, awareness, quality of life, disability, physical activity level)?
Patients will start their first exercise session on the day they will be discharged from the hospital. Patients in both exercise groups will be provided with cervical normal joint movement (ROM), posture and patient education on the day of discharge. They will be asked to do posture exercises and neck exercises under the guidance of a physiotherapist. Patients in the stabilization exercise group (experiment) will undergo stabilization exercises under the supervision of a physiotherapist, in addition to the practices in the standard exercise group. Both groups will do a warm-up program before exercise and a cool-down program afterwards. Patients will be asked to do the exercises face to face with a physiotherapist 3 days a week. The first evaluations will be made on the day they come to the outpatient clinic for examination before surgery. Post-surgical evaluations will be made routinely after the exercise program is completed, when they are called by the physician for a check-up (6th week).
Researchers will compare the standard exercise group with the stabilization exercise group to see if pain, dysfunction, normal joint movement, proprioception, balance, muscular endurance, postural alignment and related factors (kinesiophobia, awareness, quality of life, disability, physical activity level) are different. conditions: Cervical Spine Disease conditions: Surgery conditions: Rehabilitation conditions: Exercise studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 36 type: ESTIMATED name: Stabilization Exercises name: Standard Exercises measure: Pain intensity measure: Dysfunction measure: Joint Range of Motion measure: Proprioception measure: Balance measure: Neck Extensor Muscle Endurance measure: Neck Flexor Muscles Endurance measure: Postural Alignment measure: Kinesiophobia measure: Neck Awareness measure: Life Quality measure: Disability measure: Physical Activity Level measure: Sociodemographic İnformation measure: Sociodemographic İnformation BMI measure: Health-related Habits measure: Dominant Side sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Izmir Katip Celebi University Ataturk Education and Research Hospital status: RECRUITING city: İzmir country: Turkey name: Hasan Kamil SUCU, Prof. Dr. role: CONTACT name: Hilal UZUNLAR, MSc, RC role: PRINCIPAL_INVESTIGATOR name: Sevtap GUNAY UCURUM, Assoc. Dr. role: PRINCIPAL_INVESTIGATOR name: Ismail Ertan SEVİN, Prof. Dr. role: SUB_INVESTIGATOR lat: 38.41273 lon: 27.13838 hasResults: False
<|newrecord|> nctId: NCT06279364 id: SKB264-Ⅲ-11 briefTitle: A Study of SKB264 Versus Investigator's Choice Chemotherapy in Patients With Unresectable Recurrent or Metastatic Triple-Negative Breast Cancer overallStatus: NOT_YET_RECRUITING date: 2024-02 date: 2026-07 date: 2026-07 date: 2024-02-28 date: 2024-02-28 name: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. class: INDUSTRY briefSummary: The aim of the study is to evaluate the efficacy and safety of SKB264 as first-line treatment for patients with unresectable recurrent or metastatic triple-negative breast cancer (TNBC) whose tumors do not express programmed cell death ligand 1 (PD-L1) or in patients with PD-L1 positive tumors who received prior anti-programmed cell death 1 (PD-1)/PD-L1 inhibitor in early setting conditions: Triple Negative Breast Cancer studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants will be randomised in a 1:1 ratio to one of two intervention groups. primaryPurpose: TREATMENT masking: NONE count: 524 type: ESTIMATED name: SKB264 name: Paclitaxel name: Nab-paclitaxel name: Capecitabine name: Eribulin name: Carboplatin measure: Overall Survival (OS) measure: Progression Free Survival (PFS) assessed by Blinded Independent Central Review (BICR) measure: Objective Response Rate (ORR) measure: Duration of Response (DoR) measure: Progression-Free Survival (PFS) assessed by Investigator measure: Disease control rate (DCR) measure: Time to Response (TTR) measure: Adverse events(AEs) and severe adverse events (SAEs) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fudan University Shanghai Cancer Center city: Shanghai state: Shanghai country: China name: Zhimin Shao role: CONTACT email: szm@163.com lat: 31.22222 lon: 121.45806 hasResults: False
<|newrecord|> nctId: NCT06279351 id: Thalicolorectal briefTitle: Thalidomide Enhances Clinical Efficacy of Cetuximab Combined With Standard Chemotherapy for Left Colorectal Cancer overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-12-31 date: 2024-12-31 date: 2024-02-28 date: 2024-02-28 name: Xinqiao Hospital of Chongqing class: OTHER name: Chongqing Medical University briefSummary: 1. To verify that thalidomide can increase the efficacy of cetuximab plus chemotherapy in the treatment of stage IV RAS and BRAF wild-type unresectable left colorectal cancer, which has important clinical significance and provides a basis for subsequent large-scale research and clinical application.
2. To evaluate the changes of cytokines and verify the effect of some cytokines on the efficacy of cetuximab +FOLFIRI, so as to provide a scientific basis for the subsequent precise therapy using cytokines antibodies. conditions: Thalidomide Enhances Clinical Efficacy of Cetuximab Combined With Standard Chemotherapy for Left Colorectal Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 96 type: ESTIMATED name: Thalidomide+cetuximab+FOLFOX/FOLFIRI measure: ETS measure: ORR measure: DCR measure: PFS sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<|newrecord|> nctId: NCT06279338 id: [2023] No.0969 briefTitle: A Novel Conditioning Regimen for Myelodysplastic Syndrome With Moderate High IPSS-M Score overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2026-01-31 date: 2026-01-31 date: 2024-02-28 date: 2024-02-28 name: Wuhan Union Hospital, China class: OTHER briefSummary: Figure out the Efficacy and Safety of Azacitidine Combined with BUCY2 Conditioning Regimen Before Allogeneic Hematopoietic Stem Cell Transplantation for Myelodysplastic Syndrome with Moderate High IPSS-M Score conditions: Myelodysplastic Syndromes studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: Azacitidine Injection measure: Progression-free survival (PFS) at 18 months post-transplant, month measure: Overall survival (OS) at 18 months post-transplant, month sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<|newrecord|> nctId: NCT06279325 id: C.I. PI23/637 briefTitle: Effects of a Computerized Cognitive Stimulation Intervention Adapted to the Level of Cognitive Reserve overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-05-31 date: 2025-01-15 date: 2024-02-28 date: 2024-02-28 name: Universidad de Zaragoza class: OTHER briefSummary: Normal ageing presents subtle cognitive changes that can be detected before meeting the criteria for Mild cognitive impairment (MCI). Older people with low cognitive reserve and who receive limited cognitive stimulation are at greater risk of deterioration. In this regard, cognitive stimulation (CS) has been identified as an intervention that reduces this risk, provided that its design considers the differences in the level of cognitive reserve (CR) acquired throughout life and the baseline level of cognitive functioning. The general objective of this study is to evaluate, through a randomized clinical trial, the effectiveness of a computerized cognitive stimulation program, designed and adapted from Occupational Therapy based on the level of cognitive reserve in older adults in Primary Care. 100 participants will be randomized in a stratified manner according to the level of cognitive reserve (high/low), assigning 50 participants to the control group and 50 participants to the intervention group. The intervention group will carry out a computerized cognitive stimulation intervention designed and adapted from occupational therapy according to the level of cognitive reserve, through the "stimulus" platform. The main result expected to be achieved is the improvement of higher brain functions. As secondary results, the investigators expect that those cognitive aspects most vulnerable to ageing will decrease more slowly (in areas such as memory, executive function, attention and processing speed) and that the cognitive reserve of the participants will increase, in addition to being able to balance gender differences in these aspects. The investigators think that these results can positively impact the creation of adapted, meaningful and stimulating CS programs in older adults to prevent MCI and experience healthier ageing. conditions: Mild Cognitive Impairment conditions: Cognitive Dysfunction studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 100 type: ESTIMATED name: Computerized cognitive stimulation program name: Face-to-face training-explanatory session measure: MEC-35 (Spanish version of Folstein's Mini-Mental) measure: Cognitive Reserve Questionnaire (CRQ) measure: Set-Test measure: The SDMT or Symbols and Digits Test measure: Color Word Stroop Test (CWST) measure: Verbal Learning Test (TAVEC) measure: Mobile Device Proficiency Questionnaire in Short Form (MDPQ-16) sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<|newrecord|> nctId: NCT06279312 id: N202311065 briefTitle: The Effect of Adaptogen Elixir on Sleep Improvement overallStatus: RECRUITING date: 2024-02-26 date: 2024-07-31 date: 2024-12-31 date: 2024-02-28 date: 2024-03-15 name: TCI Co., Ltd. class: INDUSTRY briefSummary: This study aims to examine the effectiveness of Adaptogen Elixir herbal drink in relieving emotions and improving sleep quality. Participants will be randomly assigned to either the placebo group or the Adaptogen Elixir herbal drink group, with 25 participants in each group. On the day of the experiment (week 0), participants are required to collect blood and saliva samples, fill out questionnaires assessing sleep disorders and stress condition, and use a sleep monitoring system to track their sleep and autonomic nervous system conditions. Subsequently, participants will be given the experimental samples and instructed to consume them continuously for 4 weeks following the instruction. Follow-up assessments will be conducted in the 2nd and 4th weeks, participants are required to collect blood and saliva samples, fill out questionnaires assessing sleep disorders and stress condition, and use a sleep monitoring system to track their sleep and autonomic nervous system conditions. conditions: Sleep Disorder conditions: Anxiety Disorders studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 50 type: ESTIMATED name: Placebo drink name: Adaptogen Elixir drink measure: Sleep monitoring measure: Sleeping qualityy measure: Sleeping disorders measure: Neuropeptide Y concentration measure: Cortisol concentration measure: Anxiety measure: Low Frequency/High Frequence (LF/HF) ratio sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Taipei Medical University status: RECRUITING city: Taipei country: Taiwan name: Hsin-Chien Lee, Doctor role: CONTACT phone: +886-02-22490088 phoneExt: 79213/8158 email: ellalee@tmu.edu.tw lat: 25.04776 lon: 121.53185 hasResults: False
<|newrecord|> nctId: NCT06279299 id: LLND briefTitle: Lateral Pelvic Lymph Node Dissection for Rectal Neuroendocrine Neoplasms Undergoing Laparoscopic Total Mesenteric Excision overallStatus: RECRUITING date: 2022-08-01 date: 2028-08-01 date: 2028-08-01 date: 2024-02-28 date: 2024-02-28 name: National Cancer Center, China class: OTHER briefSummary: The purpose of this study is to investigate the metastatic status of lateral pelvic lymph nodes in rectal neuroendocrine neoplasms (rNENs) undergoing laparoscopic total mesenteric excision (TME). The hypothesis is that the rate of lateral lymph node metastasis is underestimated in rNENs undergoing TME, necessitating concurrent lateral Pelvic lymph node dissection. conditions: Rectal Neuroendocrine Neoplasm studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: lateral pelvic lymph node dissection measure: The rate of lateral pelvic lymph node metastasis measure: The rate of lymph node metastasis measure: Disease-free survival rate measure: Overall survival rate measure: Locoregional recurrence free survival rate measure: Radical resection (R0) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: National Cancer Center status: RECRUITING city: Beijing state: Beijing zip: 100000 country: China name: Haitao Zhou, M.D. role: CONTACT phone: +8613381167333 email: zhouhaitao01745@163.com name: Yueyang Zhang, M.D. role: CONTACT phone: +8613552910035 email: yyzhang0129@163.com lat: 39.9075 lon: 116.39723 hasResults: False
<|newrecord|> nctId: NCT06279286 id: HS-10506-201 briefTitle: Phase Ⅰb/Ⅱ Study of HS-10506 in Chinese Participants With Insomnia Disorder overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-01 date: 2025-01 date: 2024-02-28 date: 2024-04-23 name: Jiangsu Hansoh Pharmaceutical Co., Ltd. class: INDUSTRY briefSummary: The primary purpose of this phase Ⅰb/Ⅱ study is to investigate the safety, tolerability, pharmacokinetics (the study of the way a drug enters and leaves the blood and tissues over time) after multiple dose administration and the efficacy of HS-10506 (change versus placebo) on latency to persistent sleep (LPS) measured by polysomnography (PSG) in Chinese adult participants with insomnia disorder. conditions: Insomnia Disorder studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 312 type: ESTIMATED name: HS-10506 name: Placebo measure: Incidence and severity of adverse events (AE) measure: Incidence and severity of serious adverse events (SAE) measure: Changes in laboratory test before and after drug administration measure: Changes in ECG before and after drug administration measure: Changes in Karolinska Sleepiness Scale (KSS) scores before and after drug administration measure: Change from baseline in the mean LPS measured by PSG on Night 13 and Night 14 measure: The maximum plasma concentration (C[max]) measure: Time to reach the maximum plasma concentration (T[max]) measure: Area under the plasma concentration-time curve from time zero to last time of quantifiable concentration (AUC[0-t]) measure: Terminal elimination half-life (t1/2) measure: Change in latency to persistent sleep (LPS) relative to baseline on night 5 of PSG monitoring measure: Change in Wake After Sleep Onset (WASO) relative to baseline on night 5 of PSG monitoring measure: Change from baseline in mean LPS measured by PSG measure: Change from baseline in mean TST measured by PSG measure: Change from baseline in mean WASO measured by PSG measure: Change from baseline in the mean values of self-reported sleep-onset latency (sSOL) recorded in the sleep diary measure: Change from baseline in the mean values of self-reported total sleep time (sTST) recorded in the sleep diary measure: Incidence and severity of adverse events (AE) measure: Incidence and severity of serious adverse events (SAE) sex: ALL minimumAge: 18 Years maximumAge: 64 Years stdAges: ADULT facility: Xuanwu Hospital Capital Medical University city: Beijing country: China name: yuping Wang, PhD role: CONTACT email: wangyuping01@sina.cn lat: 39.9075 lon: 116.39723 hasResults: False
<|newrecord|> nctId: NCT06279273 id: NZhong-005 briefTitle: A Study for the Risky Decision-making Deficits Among Methamphetamine Dependence Individuals and Treatment overallStatus: ACTIVE_NOT_RECRUITING date: 2023-01-01 date: 2024-07-31 date: 2025-12-31 date: 2024-02-28 date: 2024-02-28 name: Shanghai Mental Health Center class: OTHER name: Wuhan Mental Health Centre name: Wuhan Judicial Bureau Hanyang Compulsory Isolated Detoxification Center briefSummary: The risky decision-making deficits is the core feature of the methamphetamine (MA) dependence. Our previous research found that MA dependents have network abnormalities such as decision-making and rewarding. The feedback-related negativity amplitude in the prefrontal central area of MA users becomes smaller and blunted after a loss. Moreover, the neural modulation over the prefrontal cortex showed potent to decrease the craving, and the functional connectivity between frontal cortex and subparietal lobules increases. It suggests that there is a correlation between the decision-making network and the reward network of MA addicts, but there is no real-time observation of the dynamic changes of these brain network activities, so it is difficult to correct the interaction mechanism.
In order to clarify the dynamic brain network mechanism of the risky decision-making deficits among MA dependents, firstly, based on magneto-encephalography source information reconstruction methods, firstly, based on magneto-encephalography source information reconstruction methods, the investigators will observe the sequence and interaction among decision-making network, rewarding network, and emotion network. Besides, the investigators clarify that the trans-cranial current stimulation over prefrontal cortex could improve the speed and intensity of the key network interactions among MA dependents, which could improve risky decision-making and craving. The successful implementation of the study is expected to provide important clues for elucidating the pathological mechanism of risky decision-making deficits in MA dependents and providing a theoretical basis for the treatment of addiction. conditions: Methamphetamine Use Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Transcranial direct current stimulation measure: Frontal lobe activation level measure: cue-induced craving measure: Cognitive function measure: Attention bias towards methamphetamine sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Shanghai Mental Health Center city: Shanghai country: China lat: 31.22222 lon: 121.45806 hasResults: False
<|newrecord|> nctId: NCT06279260 id: 2023.295RMH21343Protocol_V2.0 briefTitle: National Robotics-Assisted Radical Prostatectomy Database overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2029-12 date: 2030-12 date: 2024-02-28 date: 2024-04-25 name: Melbourne Health class: OTHER name: Peter MacCallum Cancer Centre, Australia name: Epworth Healthcare name: St Vincent's Hospital name: Austin Health briefSummary: Surgical notes are detailed reports written by surgeons during and after surgeries. These notes cover everything from the techniques, instruments used, any issues with the surgical procedure and post-surgical care for the patient. This information is a treasure trove for researchers because they can study it to understand how surgeries go, what works best, and how certain treatments affect patients.
By looking closely at these notes, researchers can find patterns and trends, helping them in understanding what makes surgeries successful and identify the best ways to perform them. This information is crucial for creating guidelines based on solid evidence. Also, these surgical notes are a goldmine for looking back at past surgeries to see how they have affected patients in the long run.
The real power for research comes when we combine these surgical notes within the Electronic Medical Records (EMR) and research databases. This makes it easy to collect information systematically, making it simpler for researchers to study a large number of cases. Unfortunately, not many people have paid attention to this idea for a long time, leading to big gaps in the data collection.
To address this issue, we aim to create a database that collects information from surgical notes effortlessly. This includes details about how surgeons are trained and how they progress. It's important to make sure that doctors work aligns with research - which is the best way to address data collection issues. This data can also help record different technical aspects of surgery and different surgeons' learning curve, making it easier to compare and improve training. Thus, we aim to standardise notes that are the same across different hospitals conducting robotic-assisted surgeries for prostatectomy. conditions: Database conditions: Prostate Cancer conditions: Robotic-assisted Radical Prostatectomy conditions: Surgical Outcomes conditions: Oncological Outcomes conditions: Patient Reported Outcome Measures conditions: Learning Curve studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 10000 type: ESTIMATED measure: To provide a standardized framework, enabling robust evidence strengthening & analyses, trend identification, and the formulation of evidence-based guidelines for the individualized management of PCa. measure: Patient reported quality of life outcome measures measure: Surgical measure: Oncological sex: MALE minimumAge: 16 Years maximumAge: 90 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Austin Healthcare city: Melbourne state: Victoria zip: 2084 country: Australia name: Damien Bolton role: CONTACT lat: -37.814 lon: 144.96332 facility: E.J Whitten Prostate Cancer Centre, Epworth Healthcare city: Melbourne state: Victoria zip: 3002 country: Australia lat: -37.814 lon: 144.96332 facility: St. Vincent's Private Hospital city: Melbourne state: Victoria zip: 3002 country: Australia name: Lih-Ming Wong role: CONTACT lat: -37.814 lon: 144.96332 facility: Peter MacCallum Cancer Centre city: Melbourne state: Victoria zip: 3050 country: Australia name: Marlon Perara role: CONTACT lat: -37.814 lon: 144.96332 facility: Royal Melbourne Hospital city: Melbourne state: Victoria zip: 3050 country: Australia name: Nathan Lawrentschuk role: CONTACT lat: -37.814 lon: 144.96332 hasResults: False
<|newrecord|> nctId: NCT06279247 id: KYLL-202212-011 briefTitle: Proteomics and Metabolomics of Body Fluid in Patients With Narcolepsy overallStatus: RECRUITING date: 2022-09-01 date: 2024-09 date: 2024-09 date: 2024-02-28 date: 2024-03-15 name: Qilu Hospital of Shandong University class: OTHER briefSummary: Narcolepsy (NRL) is a rare chronic central nervous system dysfunction disease, which is more common in children and adolescents, and less common in adults. Its typical clinical features include excessive daytime sleep, paroxysmal cataplexy, sleep paralysis and sleep hallucination. In addition to the above typical manifestations, patients with narcolepsy can also manifest as hyperappetite, weight gain, multiple dreams, sleep fragmentation, anxiety and depression and other emotional disorders. In particular, in narcolepsy type 1 with cataplexy, cataplexy episodes can be confused with falls caused by seizures, transient ischemic attacks or neuromuscular disorders, or even mental conversion disorders. Due to its diverse clinical symptoms, it is easy to be missed and misdiagnosed.
At present, the pathogenesis of narcolepsy is still unclear, and its pathogenesis may be related to immune, genetic, environmental, infection, central nervous system degeneration and other factors. This study aims to investigate the changes of body fluid proteomics and metabolomics in patients with narcolepsy, and to provide an important basis for the pathogenesis of narcolepsy. conditions: Narcolepsy studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 60 type: ESTIMATED measure: To screen potential molecular markers related to the biological characteristics and prognosis of narcolepsy. sex: ALL minimumAge: 5 Years maximumAge: 100 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Qilu Hospital of Shandong University status: RECRUITING city: Jinan state: Shandong zip: 250012 country: China name: Wenjing Jiang role: CONTACT phone: 18560082210 email: jiangwenjing@qiluhospital.com lat: 36.66833 lon: 116.99722 hasResults: False
<|newrecord|> nctId: NCT06279234 id: C4001002 briefTitle: A Study to Learn How Different Amounts of PF-06954522 Are Tolerated and Act in Adults With Type 2 Diabetes Mellitus overallStatus: RECRUITING date: 2024-02-20 date: 2024-12-31 date: 2024-12-31 date: 2024-02-28 date: 2024-04-11 name: Pfizer class: INDUSTRY briefSummary: The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of multiple escalating oral doses of PF-06954522 in adult participants with inadequately controlled type 2 diabetes mellitus (T2DM) on metformin (Part A) and optionally in non-diabetic participants with obesity (Part B). conditions: Type 2 Diabetes Mellitus (T2DM) conditions: Obesity studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: NONE count: 122 type: ESTIMATED name: Placebo name: Rosuvastatin name: Midazolam name: Omeprazole name: PF-06954522 measure: Number of Participants Reporting Adverse Events measure: Number of Participants with Clinically Significant Change From Baseline in Laboratory Abnormalities measure: Number of Participants With Clinically Significan Change From Baseline in Vital Signs measure: Number of Participants With Clinically Significant Change From Baseline in 12-Lead ECGs measure: Number of Participants with categorical scores on the Columbia Suicide Severity Rating Scale (C-SSRS) measure: Number of Participants With Change From Baseline in Physical Examination measure: Maximum Observed Plasma Concentration (Cmax) measure: Area Under the Curve from Time Zero to end of dosing interval (AUCtau) measure: Time to Reach Maximum Observed Plasma Concentration (Tmax) measure: Plasma Decay Half-Life (t1/2) measure: Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) measure: Percentage of Dose of PF-06751979 Excreted Unchanged in the Urine Over the Dosing Interval Tau (Aetau%) measure: Renal Clearance (CLr) sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Anaheim Clinical Trials, LLC status: RECRUITING city: Anaheim state: California zip: 92801 country: United States lat: 33.83529 lon: -117.9145 facility: Qps-Mra, Llc status: RECRUITING city: South Miami state: Florida zip: 33143 country: United States lat: 25.7076 lon: -80.29338 hasResults: False
<|newrecord|> nctId: NCT06279221 id: B7981055 briefTitle: Litfulo Capsules Special Investigation overallStatus: NOT_YET_RECRUITING date: 2024-04-30 date: 2030-06-25 date: 2030-06-25 date: 2024-02-28 date: 2024-02-28 name: Pfizer class: INDUSTRY briefSummary: The objective of this Study is to confirm the safety during the long-term use of this drug and the effectiveness during the use of this drug under the actual use in the patients treated with this drug. conditions: Alopecia Areata studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 850 type: ESTIMATED name: LITFULO measure: Proportion of participants with adverse events (AEs) measure: Percentage of patients achieving SALT≤20 [SALT score (absolute value) 20 or less] sex: ALL minimumAge: 12 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<|newrecord|> nctId: NCT06279208 id: 2023-A00272-43 briefTitle: Phosphoproteomic Profile of Children With Down Syndrome acronym: PEPS overallStatus: RECRUITING date: 2024-03-18 date: 2024-09 date: 2024-09 date: 2024-02-28 date: 2024-04-01 name: Perha Pharmaceuticals class: INDUSTRY name: Proteas Bioanalytics name: Göteborg University briefSummary: One of the major causes of cognitive disorders limiting the learning abilities of children with Down's syndrome is excess activity of the DYRK1A protein kinase, whose gene is located on chromosome 21. Consequently, variations in the level of phosphorylation, and hence activity, of DYRK1A target proteins involved in synaptic transmission, could identify mechanisms underlying these cognitive disorders.
Several studies have shown that plasma proteins can reflect a pathophysiological brain state. The investigators plan to carry out a phosphoproteomic study to determine the phosphorylation profile of plasma proteins in children with Down's syndrome, and identify potential DYRK1A-dependent pathophysiological mechanisms and biomarkers involved in the natural course of cognition in children with Down's syndrome. conditions: Down Syndrome studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 60 type: ESTIMATED name: Blood sample measure: Phosphoproteomic profile measure: Identification of brain proteins measure: Impact of environnement on phosphoproteomic profile measure: Impact of DYRK1A on Down Syndrome specific proteomic profile sex: MALE minimumAge: 6 Years maximumAge: 12 Years stdAges: CHILD facility: CHU Grenoble status: NOT_YET_RECRUITING city: Grenoble country: France name: Dr Marey role: CONTACT phone: 0476767285 lat: 45.16667 lon: 5.71667 facility: Hospices Civils de Lyon status: RECRUITING city: Lyon country: France name: Dr Sanlaville role: CONTACT phone: 0427855573 lat: 45.74848 lon: 4.84669 facility: Institut Jérôme Lejeune status: RECRUITING city: Paris country: France name: Dr Cieuta-Walti role: CONTACT phone: 0156586300 lat: 48.85341 lon: 2.3488 facility: CHU Rennes status: RECRUITING city: Rennes country: France name: Dr Jean-Marçais role: CONTACT phone: 0299266744 lat: 48.11198 lon: -1.67429 facility: CHU Saint-Etienne status: NOT_YET_RECRUITING city: Saint-Etienne country: France name: Dr Touraine role: CONTACT phone: 0477828116 lat: 45.43389 lon: 4.39 hasResults: False
<|newrecord|> nctId: NCT06279195 id: EH23-326 briefTitle: Phenotyping of Idiopathic Pelvic Pain With Real-time Uterine Imaging and Relugolix-Combination Therapy Treatment overallStatus: NOT_YET_RECRUITING date: 2024-04-05 date: 2025-08-02 date: 2025-08-02 date: 2024-02-26 date: 2024-02-28 name: NorthShore University HealthSystem class: OTHER name: Pfizer briefSummary: The mechanisms underlying variable efficacy of Relugolix-Combination Therapy (REL-CT) in mitigating unexplained pelvic pain will be evaluated with uterine imaging techniques and quantitative sensory testing. conditions: Pelvic Pain studyType: INTERVENTIONAL phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants in two groups with different conditions will be give REL-CT. primaryPurpose: BASIC_SCIENCE masking: NONE count: 60 type: ESTIMATED name: Relugolix (40 mg) /estradiol (1 mg)/norethisterone acetate (0.5 mg) oral tablet measure: Correlation between post-treatment pelvic pain and baseline uterine contraction frequency measure: Correlation between post-treatment pelvic pain and baseline sensory hypersensitivity Z-score. sex: FEMALE minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT facility: NorthShore University HealthSystem city: Evanston state: Illinois zip: 60201 country: United States name: Kevin Hellman, PhD role: CONTACT phone: 847-570-2622 email: khellman@northshore.org lat: 42.04114 lon: -87.69006 hasResults: False
<|newrecord|> nctId: NCT06279182 id: IRB-FY2024-106 briefTitle: Impact of Barre Stretching Among Dental Hygiene Students overallStatus: NOT_YET_RECRUITING date: 2024-02 date: 2024-03 date: 2024-04 date: 2024-02-26 date: 2024-02-26 name: Idaho State University class: OTHER briefSummary: The healthcare profession of dental hygiene can be a highly stressful academic path and occupation. Physical stressors can quickly lead to postural disturbances and musculoskeletal disorders (MSDs) due to instrument grasping while under muscle tension, working with vibrating instruments, and performing repetitive micromovements. Chronic, high stress levels have the potential to lead to burnout, fatigue, and other health problems, which can impact a student's ability to perform well in their clinical rotations and didactic studies and may translate into their workforce experiences after graduation.
The purpose of this study is to determine whether a relationship exists between Barre stretching and reported stress and pain levels among entry-level dental hygiene students.
This study will be a 6-week experimental randomized control trial (RCT) where participants will be assigned to a 15-minute Barre stretching and breathing video two times a week for the experimental group or control group. The continuous dependent variables in this study will be the reported stress levels and reported pain levels of the entry-level dental hygiene students. The independent variable will be the Barre stretching intervention. The participants will include students at two universities enrolled in an entry-level dental hygiene program as first-year students.