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* overall survival |
* factors influencing overall survival, progression-free survival, and time to progression |
* Symptoms and signs of the disease during the diagnosis and relapse phases, including the causes of mortality in plasma cell disorder patients. |
* genetic characteristics of plasma cell disorder |
* cost-effectiveness of treatment in Thailand Participants will be collected the data of baseline diagnosis, treatment, treatment results of all admission and follow-up visits from hospital medical record. conditions: Plasma Cell Disorders studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 750 type: ESTIMATED measure: register the plasma cell disorder patients measure: incidence of plasma cell disorders measure: Time to progression measure: Progression free survival measure: overall survival measure: influencing factors measure: Symptoms and signs measure: genetic characteristics measure: cost-effectiveness sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06286202 id: RECAS-0306 briefTitle: Integrative Neuro-social Cognitive Strategy Programme for Instilling REcovery (INSPIRE) a Community-Based Cognitive Remediation Trial overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-12 date: 2027-07 date: 2024-02-29 date: 2024-03-04 name: Singapore Institute of Technology class: OTHER name: Singapore Anglican Community Services briefSummary: Adults with serious mental illnesses (such as schizophrenia and schizoaffective disorders) often experience a range of cognitive difficulties (such as memory, problem solving difficulties) that affect their ability to lead meaningful life roles. Cognitive remediation is an intervention to address cognitive difficulties in this group of mental health service users. Its implementation in less well-resourced community-based settings is less well-studied. |
Therefore, the aims of the study are: |
* To investigate the effects of cognitive remediation on various cognitive skills (such as attention, memory, problem-solving, facial expression recognition, taking others' perspectives etc), for participants with schizophrenia or schizoaffective disorders in community mental health settings. |
* To investigate if factors such as participants' motivation for engagement and social interaction can affect changes in cognitive skills and functional ability. |
Participants in the treatment group will attend computer-based cognitive exercises to improve their cognitive skills. They will also participate in group sessions facilitated by therapists to learn how to utilize strategies learned from the computer sessions in their daily lives. Participants in the control group will attend the usual rehabilitation activities in their respective community-based psychiatric rehabilitation centers. |
This research study will compare the differences in their cognitive performance, functional ability and recovery immediately after the intervention and 8 weeks later. conditions: Schizophrenia conditions: Schizoaffective Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The intervention study model is a parallel randomized controlled trial. There will be two arms. The experimental arm is 'cognitive remediation' and the control arm is 'standard psychiatric rehabilitation'. Participants will be assigned to one of the treatment arms at the beginning of the trial and will continue in that arm throughout the length of the trial. Assignment to the group is done using a computer randomization generator. All eligible participants will be randomly assigned to one of the treatment arms (experimental or control arm) based on a 1:1 treatment allocation. Hence, those who are randomly allocated to the experimental arm will receive cognitive remediation throughout the trial, while those randomly allocated to the control arm will receive standard psychiatric rehabilitation throughout the trial. Both treatment arms will run in parallel. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Upon randomization, the co-investigators will indicate the allocated group in a separate spreadsheet from the outcome measurements. The co-investigator who is collecting baseline, post-intervention and 8-week outcome measurements will be blinded to the treatment allocation of each participant. whoMasked: OUTCOMES_ASSESSOR count: 160 type: ESTIMATED name: Cognitive Remediation: Adapted Neuropsychological and Education Approach to Remediation (NEAR) name: Standard Psychiatric Rehabilitation at Anglican Care Centers measure: Brief Assessment of Cognition in Schizophrenia (BACS) measure: Penn Emotion Recognition Task (ER40) measure: The Awareness of Social Inference Test (TASIT)- Part 3 measure: Goal Attainment Scale measure: Social and Occupational Functioning Assessment Scale (SOFAS) measure: Recovery Assessment Scale-Domain and Stages (RAS-DS) measure: Positive and Negative Syndrome Scale (PANSS) measure: Brief Negative Symptom Scale (BNSS) measure: Brief Regulation of Motivation Scale (BRoMS) measure: The Global Assessment of Functioning Scale (GAF) sex: ALL minimumAge: 21 Years maximumAge: 60 Years stdAges: ADULT facility: Anglican Care Center-Bukit Batok city: Singapore country: Singapore name: Jonathan Poh, MA role: CONTACT phone: +6592333020 email: Jonathan_poh@sacs.org.sg lat: 1.28967 lon: 103.85007 facility: Anglican Care Center-Hougang city: Singapore country: Singapore name: Mingxiu Cai, BSc (Hons) role: CONTACT phone: +6563869338 phoneExt: 101 email: mingxiu_cai@sacs.org.sg lat: 1.28967 lon: 103.85007 facility: Anglican Care Center-Simei city: Singapore country: Singapore name: Noel Tan, MA role: CONTACT phone: +6591853094 email: noel_tan@sacs.org.sg lat: 1.28967 lon: 103.85007 hasResults: False |
<|newrecord|> nctId: NCT06286189 id: 2020P002760-t briefTitle: Trazodone on OSA Endotypes overallStatus: RECRUITING date: 2024-01-01 date: 2025-01-01 date: 2025-06-01 date: 2024-02-29 date: 2024-02-29 name: Brigham and Women's Hospital class: OTHER briefSummary: Obstructive sleep apnea (OSA) is common and has major health implications but treatment options are limited. Some OSA patients with low arousal threshold wake up prematurely during an obstructive event and do not have time for spontaneous upper airway (UA) dilator muscle recruitment. As a consequence they are exposed to apnea and hypopnea cycling. In this protocol the investigators will test the effect of trazodone administered before sleep on OSA traits and OSA severity during sleep. conditions: Obstructive Sleep Apnea studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 18 type: ESTIMATED name: Placebo oral tablet name: Trazodone Hydrochloride measure: Effect of trazodone on arousal threshold (%eupnea) measure: Effect of trazodone on apnea hypopnea index (events/h) sex: ALL minimumAge: 21 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Brigham and Women's Hospital status: RECRUITING city: Boston state: Massachusetts zip: 02115 country: United States name: Nicole Calianese, BS role: CONTACT phone: 617-732-8976 email: ncalianese@mgb.org lat: 42.35843 lon: -71.05977 hasResults: False |
<|newrecord|> nctId: NCT06286176 id: LIUIRB-200311-NR1 briefTitle: Breastfeeding Promotion in Lebanon Through a Salutogenic Intervention overallStatus: COMPLETED date: 2022-11-17 date: 2023-06-30 date: 2023-06-30 date: 2024-02-29 date: 2024-02-29 name: Nabiha Ramadan class: OTHER name: Universitat de Girona briefSummary: The study is a randomized control trial to assess the effect of a salutogenic intervention on breastfeeding initiation and duration of exclusive breastfeeding in Lebanon. In this Salutogenic intervention, infant feeding helpers will provide subjects of the intervention group breastfeeding related information , and will support these subjects by counseling and guiding them to find general resistance resources. This aims to increase sense of coherence and its parameters: comprehensibility, manageability and meaningfulness, which are the base of salutogenesis. conditions: Breast Feeding conditions: Exclusive Breastfeeding conditions: Salutogenesis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 101 type: ACTUAL name: Videos with breastfeeding education material and encouraging messages name: Whatsapp group measure: breastfeeding initiation measure: Duration of Exclusive breastfeeding measure: Mean change in Self- esteem in participants from baseline to 6 months postpartum measure: The Change in Sense of Coherence (SOC) scores from baseline to 6 months postpartum sex: FEMALE minimumAge: 20 Years maximumAge: 40 Years stdAges: ADULT facility: Lebanese International University city: Beirut zip: 146404 country: Lebanon lat: 33.88894 lon: 35.49442 hasResults: False |
<|newrecord|> nctId: NCT06286163 id: PA4099 briefTitle: Neuroinflammatory Interactions of ATP and P2X3 Receptor in the Airways of Chronic Cough Patients overallStatus: RECRUITING date: 2023-10-01 date: 2024-12-31 date: 2025-06-30 date: 2024-02-29 date: 2024-02-29 name: Imperial College London class: OTHER name: Merck Sharp & Dohme LLC briefSummary: This study is being done in order to understand what causes people to have a chronic cough, which is defined as a cough lasting for more than 8 weeks. The research team wish to find out whether there is any inflammation in the lungs of patients with chronic cough. The research team will also determine whether a suspected chemical produced in the body, called adenosine triphosphate (ATP) can be responsible for causing the chronic cough. In order to be able to find out what is abnormal in those who have a chronic cough, The research team will need to compare their results with those that do not have a chronic cough. |
In this study, the research team will examine 10 participants who suffer from chronic cough and 8 individuals who do not have a chronic cough and are healthy. conditions: Chronic Cough studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 18 type: ESTIMATED measure: Presence of ATP in airways of idiopathic chronic cough patients and the localisation of P2X2/3 receptors in the airways measure: Cough sensitivity and laryngeal sensitivity to exogenous ATP measure: Examine the effects of exogenous ATP on the inflammatory response in the upper and lower airways. sex: ALL minimumAge: 30 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Royal Brompton & Harefield NHS Trust, status: RECRUITING city: London zip: SW3 6HP country: United Kingdom name: Sally Meah, SRN role: CONTACT phone: 0207 3518051 email: Sally.Meah@imperial.ac.uk name: Pankaj K Bhavsar role: CONTACT phone: 02075947961 email: p.bhavsar@imperial.ac.uk lat: 51.50853 lon: -0.12574 facility: Royal Brompton Hospital status: RECRUITING city: London zip: SW3 6HP country: United Kingdom name: Kian Fan Chung, MD role: CONTACT phone: 44205947959 email: f.chung@imperial.ac.uk name: Sally Meah, SRN role: CONTACT phone: 02073518051 email: Sally.Meah@imperial.ac.uk lat: 51.50853 lon: -0.12574 hasResults: False |
<|newrecord|> nctId: NCT06286150 id: EC-2023-087(QX)-03 briefTitle: Efficacy and Safety of Single-port Surgical Robot System in Thoraic Surgery overallStatus: RECRUITING date: 2023-09-15 date: 2025-07-15 date: 2027-07-15 date: 2024-02-29 date: 2024-02-29 name: The First Affiliated Hospital of Guangzhou Medical University class: OTHER briefSummary: Robotic surgical systems have become a promising surgical assistance system, with unique advantages such as 3D high-definition visual system, highly flexible wrist-jointed instruments, and automatic fitering of hand tremors. Robotic surgical systems is applied in various fields including urology, general surgery, cardiothoracic surgery, head and neck surgery, and gynecology. Currently, the Da Vinci surgical robot system is the most widely used robot system globally. However, the Da Vinci robot system for single-port laparoscopic surgery has not yet been launched in China. Therefore, the investigators conduct a prespective, single-center study to evaluate the efficacy and safety of single-port surgical robot system in thoracic surgery. conditions: Lung Cancer studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: Surgical robot system measure: Intraoperative conversion rate measure: Surgical complications rate measure: Intraoperating bleeding volume measure: Surgical time measure: Length of hospital admissions measure: Postoperative wound pain score measure: Surgeon satisfaction measure: Adverse events measure: Rate of re-admission to hospital measure: Rate of reoperation measure: Postoperative mortality sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The First Affiliated Hospital of Guangzhou Medical University status: RECRUITING city: Guangzhou state: Guangdong zip: 510000 country: China name: Jianxing He, M.D. role: CONTACT phone: +86-20-83337792 email: hejx@vip.163.com lat: 23.11667 lon: 113.25 hasResults: False |
<|newrecord|> nctId: NCT06286137 id: NL82922.078.22 briefTitle: Duration of Music Interventions and Pain Tolerance (DOMINANT) acronym: DOMINANT overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-02 date: 2025-06 date: 2024-02-29 date: 2024-03-06 name: Erasmus Medical Center class: OTHER briefSummary: This study will investigate the effect of different durations of music interventions (1, 5 and 20 minutes of music) on pain tolerance. conditions: Pain, Acute studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The randomized controlled trial will have four study arms. Subjects will be assigned to one of the four arms: control without music and music groups with 1 minute, 5 minutes and 20 minutes. All subjects will receive electric stimuli in three phases. In each phase, subject will be exposed to three consecutive stimuli. First a detection threshold will be measured. Secondly a baseline test will be performed in order to assess basic levels of pain endurance. Hereafter, the intervention phase starts. Subjects in the music groups will listen to 1, 5 and 20 minutes of their own preferred music through headphones. Directly after, all subjects will again receive three electric stimuli. primaryPurpose: TREATMENT masking: NONE maskingDescription: Due to the nature of the study and the music intervention, it is not possible to blind participants and investigators. However, participants will not be informed of the study arm to which they are randomized in advance. count: 80 type: ESTIMATED name: Listening to music for 1 minute name: Listening to music for 5 minutes name: Listening to music for 20 minutes name: Not listening to music measure: Pain tolerance measure: Heart rate variability (HRV) measure: Level of perceived anxiety, Spielberger State-Trait Anxiety Inventory (STAI)-6 questionnaire measure: Valence and arousal, Self-Assessment manikin (SAM) questionnaire measure: Music listening Questionnaire measure: Pain intensity measure: Pain unpleasantness sex: ALL minimumAge: 18 Years maximumAge: 64 Years stdAges: ADULT facility: Erasmus Medical Center city: Rotterdam zip: 3015 GD country: Netherlands name: Emy S van der Valk Bouman, MD role: CONTACT phone: +31646461901 email: e.vandervalkbouman@erasmusmc.nl name: Antonia S Becker, MD role: CONTACT phone: +31641188966 email: a.becker@erasmusmc.nl name: Markus Klimek, MD PhD role: PRINCIPAL_INVESTIGATOR lat: 51.9225 lon: 4.47917 hasResults: False |
<|newrecord|> nctId: NCT06286124 id: 8612 briefTitle: Midline Restoration After HYbriD Hernia RepAir Surgery (HYDRA) acronym: HYDRA overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2027-04 date: 2028-04 date: 2024-02-29 date: 2024-02-29 name: Erasmus Medical Center class: OTHER name: Medtronic name: Alrijne Hospital briefSummary: The goal of this observational study is to learn about the functioning of the abdominal wall in patients who underwent hybrid (open- and laparoscopic) incisional hernia repair. The main objective is to assess the anatomical restoration and function of the linea alba one year after surgery by ultrasonography and mean peak torque during trunk flexion using a BioDex machine. conditions: Incisional Hernia of Midline of Abdomen studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 52 type: ESTIMATED name: Hybrid Surgery measure: Mean peak torque 1 year measure: Mean peak torque 2 years measure: Recurrent Incisional Hernia measure: Severity of surgical complications measure: Surgical complications measure: General Quality of Life measure: Mesh specific Quality of Life measure: Scar satisfaction measure: Pain in the abdominal region sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Alrijne Hospital city: Leiden country: Netherlands name: Willem Hueting, MSc role: CONTACT lat: 52.15833 lon: 4.49306 hasResults: False |
<|newrecord|> nctId: NCT06286111 id: ASU MD briefTitle: Red Cell Distribution Width as a Predictor for Post Operative Atrial Fibrillation After Open Heart Surgries overallStatus: NOT_YET_RECRUITING date: 2024-04-25 date: 2024-06-01 date: 2024-08-01 date: 2024-02-29 date: 2024-04-23 name: Ain Shams University class: OTHER briefSummary: In this study we investigate the correlation between RDW and POAF, as we use the RDW as a predictor for inflammation for prediction of POAF conditions: Atrial Fibrillation conditions: Inflammatory Marker conditions: Heart; Surgery, Heart, Functional Disturbance as Result studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 76 type: ESTIMATED measure: Red cell distribution width as a predictor for Post-operative Atrial fibrillation after Open Heart Surgeries sex: ALL minimumAge: 35 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06286098 id: ALA in Pediatrics on HD briefTitle: Alpha Lipoic Acid in Pediatrics on Hemodialysis overallStatus: NOT_YET_RECRUITING date: 2024-03-20 date: 2024-09-20 date: 2024-10-20 date: 2024-02-29 date: 2024-03-12 name: Ain Shams University class: OTHER name: Eva Pharma briefSummary: The goal of this clinical trial is to test alpha lipoic acid in children undergoing hemodialysis. The main questions it aims to answer are: |
* Will the use of alpha lipoic acid lower cardiovascular events in that population? |
* Is the incidence of those cardiovascular events linked to the oxidative stress and endothelial dysfunction in that population? |
* Will the drug cause side effects? |
Participants will: |
* take either one dose daily of 600mg tablet Alpha lipoic acid orally or a look-alike tablet containing no drug. |
* be monitored for the occurrence of cardiovascular events (stroke, angina, etc.) |
* be monitored for the occurrence of side effects |
* give blood samples for testing serum levels of E-selectin biomarker and superoxide dismutase enzyme |
* undergo clinical examinations (Echocardiogram, Duplex ultrasonography, Intima-Media-Thickness) Researchers will compare between the group taking alpha lipoic acid and the group taking the look-alike tablet. conditions: Hemodialysis Complication conditions: Pediatric Kidney Disease conditions: Cardiovascular Complication studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 50 type: ESTIMATED name: Alpha lipoic acid name: Placebo measure: Serum level of E-Selectin measure: Serum levels of superoxide dismutase (SOD) measure: Number of cardiovascular events measure: Number of Adverse effects sex: ALL minimumAge: 8 Years maximumAge: 16 Years stdAges: CHILD facility: New Pediatrics Hospital, Faculty of Medicine, Ain Shams University city: Cairo state: El Weili zip: 11381 country: Egypt name: Mahmoud Mohsen, Pharmacist role: CONTACT phone: +201275811494 email: mahmoudfast41@gmail.com lat: 30.06263 lon: 31.24967 hasResults: False |
<|newrecord|> nctId: NCT06286085 id: 337788 briefTitle: A Comparison of Diagnostic Testing Modalities in the Assessment of Asthma acronym: MODELS overallStatus: RECRUITING date: 2024-02-27 date: 2024-04-24 date: 2024-07-24 date: 2024-02-29 date: 2024-04-04 name: Portsmouth Hospitals NHS Trust class: OTHER_GOV briefSummary: This study aims to assess the concordance of international asthma guidelines in the diagnosis of asthma and explore the presence of airways disease using additional non-guideline physiologic criteria, such as IOS (impulse osciollometry), not included in the guidelines, but available in the Portsmouth lung function service. conditions: Asthma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 750 type: ESTIMATED name: Lung function tests measure: International asthma guidelines scores measure: non-guideline physiologic criteria measure: non-guideline physiologic criteria for asthma. measure: Comparison of the diagnostic outcomes of each guideline with a "reference standard". sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Portsmouth Hospitals University NHS Trust status: RECRUITING city: Portsmouth country: United Kingdom name: Laura Marshall role: CONTACT phone: 02392286000 email: research.office@porthosp.nhs.uk lat: 50.79899 lon: -1.09125 hasResults: False |
<|newrecord|> nctId: NCT06286072 id: YCEYHANS briefTitle: The Effect of Education and Reminder Messages on the Fatigue Level of Individuals With COPD overallStatus: RECRUITING date: 2023-11-01 date: 2024-01-30 date: 2024-03-30 date: 2024-02-29 date: 2024-02-29 name: Kirsehir Ahi Evran Universitesi class: OTHER briefSummary: COPD is an important respiratory system disease that progresses with damage to the airways.Increased mucus secretion and thickening in the airways causes obstruction.This obstruction causes symptoms such as shortness of breath, cough, phlegm and wheezing.The most obvious problem that the emerging symptoms will cause for the patient is fatigue.Coping with fatigue is an important problem in COPD. |
The main questions it aims to answer are: |
1. Does the training given in COPD affect the level of fatigue? |
2. Do the education given and text messages sent regarding COPD affect the level of fatigue? |
In this study, patients were given informative education about COPD and ways to cope with fatigue were explained. Then, in order to increase the permanence of the training, motivational messages and short briefings were continued for 8 weeks.2 messages were sent per week. Three groups were created to reveal the effectiveness of the trainings and messages. |
Group 1 was trained and messages were sent for 8 weeks. Group 2 was trained and no message was sent. Group 3 is the control group. No training has been provided other than routine maintenance. |
The initial information of all groups was taken again at the end of the 8th week. |
Main outcomes: |
* Dyspnea severity, |
* COPD general conditions and |
* Fatigue level. The results obtained will be interpreted by comparing between 3 groups. conditions: Copd conditions: Fatigue studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomised Controlled Trial primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: PARTICIPANT count: 120 type: ESTIMATED name: Education and message measure: Fatigue Level measure: Dyspnea Severity measure: COPD general condition sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Yasemin CEYHAN status: RECRUITING city: Kırşehir state: Center zip: 40100 country: Turkey name: Yasemin CEYHAN, PhD role: CONTACT phone: +9054645898065 email: yasemin-ceyhan@hotmail.com role: CONTACT phoneExt: CEYHAN email: yasemin-ceyhan@hotmail.com name: Yasemin CEYHAN, PhD role: PRINCIPAL_INVESTIGATOR lat: 39.14583 lon: 34.16389 hasResults: False |
<|newrecord|> nctId: NCT06286059 id: Phentolamine for CA-AKI briefTitle: Efficacy of Phentolamine in Prevention of Contrast-Associated Acute Kidney Injury After Complex PCI overallStatus: RECRUITING date: 2024-03-07 date: 2024-12-31 date: 2025-01-31 date: 2024-02-29 date: 2024-03-18 name: Helwan University class: OTHER briefSummary: To evaluate the efficacy and safety of phentolamine in prevention of CA-AKI following complex PCI in patients at high risk of CA-AKI. conditions: CA-AKI - Contrast-Associated Acute Kidney Injury conditions: Coronary Artery Disease conditions: Acute Coronary Syndrome conditions: Adrenergic Receptor Antagonist Adverse Reaction studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomised controlled clinical trial primaryPurpose: PREVENTION masking: SINGLE maskingDescription: Single Blinded whoMasked: PARTICIPANT count: 60 type: ESTIMATED name: Phentolamine measure: Rate of CA-AKI measure: Peak of serum creatinine elevation measure: Duration of CA-AKI measure: Change in HR measure: Change in SBP measure: Change in DBP measure: Urine output measure: Rate of RRT measure: Rate of MACE measure: Rate of rehospitalization measure: Duration of hospitalization sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Badr university hospital status: RECRUITING city: Badr state: Cairo country: Egypt name: Mohammed Soliman, MBBCH role: CONTACT phone: +201032137563 email: Mohammed_Mostafa@med.helwan.edu.eg hasResults: False |
<|newrecord|> nctId: NCT06286046 id: AG348-C-026 id: 2023-510289-28-00 type: OTHER domain: EU Clinical Trial Number briefTitle: A Study of Mitapivat in Participants With Sickle Cell Disease and Nephropathy overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2026-05 date: 2027-09 date: 2024-02-29 date: 2024-04-12 name: Agios Pharmaceuticals, Inc. class: INDUSTRY briefSummary: The primary purpose of this study is to evaluate the effect of mitapivat on albumin creatinine ratio (ACR) response in participants with sickle cell disease (SCD) and nephropathy. conditions: Sickle Cell Disease conditions: Nephropathy studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: Mitapivat measure: Percentage of Participants With Albumin Creatinine Ratio (ACR) Response measure: Change From Baseline in Cystatin C and Creatinine-based Estimated Glomerular Filtration Rate (eGFRcr-cys) measure: Change From Baseline in Albumin Creatinine Ratio (ACR) measure: Percentage of Participants With Stable ACR measure: Annualized Rate of Emergency Room (ER) Visits measure: Annualized Rate of Days of Hospitalizations measure: Type, Frequency, Severity, and Relationship to Study Drug of Adverse Events (AEs) and Serious Adverse Events (SAEs) sex: ALL minimumAge: 16 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06286033 id: AG181-C-001 briefTitle: A Safety Study of Single and Multiple Doses of AG-181 in Healthy Participants overallStatus: RECRUITING date: 2024-02-20 date: 2025-06-01 date: 2025-06-01 date: 2024-02-29 date: 2024-04-16 name: Agios Pharmaceuticals, Inc. class: INDUSTRY briefSummary: The primary purpose of this study is to assess the safety and tolerability of AG-181 in healthy participants after oral administration of single ascending dose (SAD) of AG-181 in Part 1 and multiple ascending dose (MAD) in Part 2 along with the effect of food on the pharmacokinetics (PK) of single oral doses of AG-181 in healthy participants in Part 3. conditions: Healthy Volunteers studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 120 type: ESTIMATED name: AG-181 name: Placebo measure: SAD: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) by Type, Severity, and Relationship to Study Drug measure: MAD: Number of Participants with AEs and SAEs by Type, Severity, and Relationship to Study Drug measure: Food Effect: Maximum Observed Plasma Concentration (Cmax) of AG-181 measure: Food Effect: Area Under the Concentration-time Curves (AUCs) of AG-181 measure: Food Effect: Time to Reach Maximum Observed Concentration (tmax) of AG-181 measure: Food Effect: Terminal Elimination Rate Constant (Kel) of AG-181 measure: Food Effect: Terminal Elimination Half-Life (t1/2) of AG-181 measure: Food Effect: Apparent Oral Clearance (CL/F) of AG-181 measure: Food Effect: Apparent Volume of Distribution at Terminal Phase (Vz/F) of AG-181 measure: SAD: Maximum Observed Plasma Concentration (Cmax) of AG-181 measure: SAD: Time to Reach Maximum Observed Concentration (tmax) of AG-181 measure: SAD: Terminal Elimination Rate Constant (Kel) of AG-181 measure: SAD: Terminal Elimination Half-Life (t1/2) of AG-181 measure: SAD: Area Under the Concentration-time Curves (AUCs) of AG-181 measure: SAD: Apparent Oral Clearance (CL/F) of AG-181 measure: SAD: Apparent Volume of Distribution at Terminal Phase (Vz/F) of AG-181 measure: SAD: Renal Clearance (CLR) of AG-181 measure: SAD: Total Percent of AG-181 Dose Excreted Unchanged in Urine (Fet%) measure: SAD: Percent of AG-181 Dose Excreted Unchanged in Urine Between Time 1 and Time 2 (Fet1-t2%) measure: SAD: Cumulative Amount of AG-181 Drug Excreted in Urine (Ae0-t) measure: SAD: Amount of AG-181 Drug Excreted in Urine Between Time 1 and Time 2 (Aet1-t2) measure: MAD: Maximum Observed Plasma Concentration (Cmax) of AG-181 measure: MAD: Time to Reach Maximum Observed Concentration (tmax) of AG-181 measure: MAD: Terminal Elimination Rate Constant (Kel) of AG-181 measure: MAD: Terminal Elimination Half-Life (t1/2) of AG-181 measure: MAD: Area Under the Concentration-time Curve (AUC) of AG-181 measure: MAD: Apparent Oral Clearance (CL/F) of AG-181 measure: MAD: Apparent Volume of Distribution at Terminal Phase (Vz/F) of AG-181 measure: MAD: Time to Maximum Observed Plasma Concentration at Steady State (Cmax_ss) of AG-181 measure: MAD: Accumulation Ratio for Cmax (RA_Cmax) of AG-181 measure: MAD: Accumulation Ratio for Area Under the Concentration-time Curve (RA_AUC) of AG-181 measure: Food Effect: Number of Participants with AEs and SAEs by Type, Severity, and Relationship to Study Drug sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: ICON 1255 East 3900 South status: RECRUITING city: Salt Lake City state: Utah zip: 84124 country: United States lat: 40.76078 lon: -111.89105 hasResults: False |
<|newrecord|> nctId: NCT06286020 id: VR-Zhenqiu briefTitle: Effect of Virtual Reality Therapy on Dysphagia in Wallenberg Syndrome overallStatus: RECRUITING date: 2024-02-28 date: 2024-07 date: 2024-07 date: 2024-02-29 date: 2024-03-06 name: Zeng Changhao class: OTHER briefSummary: The goal of this clinical trial is to learn about on dysphagia in wallenberg syndrome. The main questions it aims to answer are: |
the efficacy of Virtual Reality Therapy in the rehabilitation of patients with dysphagia in Wallenberg syndrome. |
Participants received conventional dysphagia treatment and Virtual Reality Therapy once a day for 14 days. Researchers compared the control group to see the effect and mechanism of Virtual Reality Therapy. conditions: Wallenberg Syndrome studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Virtual Reality Therapy name: Conventional dysphagia treatment measure: standardized swallowing assessment measure: Murray secretion scale measure: Rosenbek penetration-aspiration scale measure: swallowing-quality of life sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Xinzhu Rehabilitation Hospital status: RECRUITING city: Xinzhu country: Taiwan name: Haim Liu role: CONTACT lat: 22.46205 lon: 120.47335 hasResults: False |
<|newrecord|> nctId: NCT06286007 id: PRIPASCO-2023 briefTitle: Prevalence and Impact of Pertussis and RSV on Asthma Severity and Control acronym: PRIPASCO overallStatus: RECRUITING date: 2023-12-21 date: 2024-07-31 date: 2026-07-01 date: 2024-02-29 date: 2024-03-01 name: Hospital Clinico Universitario de Santiago class: OTHER name: Translational Research In Airway Diseases Group (TRIAD) name: CIBER of Respiratory Diseases CIBERES name: Complexo Hospitalario Universitario de A Coruña name: Hospital de Galdakao name: Hospital Universitario Doctor Peset name: Hospital San Pedro de Alcantara name: Hospital Universitario Marqués de Valdecilla name: Hospital Universitario Vall d´Hebron name: Universitat Autonoma de Barcelona name: Universidade de Santiago de Compostela name: Consortium for Biomedical Research in Epidemiology and Public Health name: Hospital Universitario Virgen del Rocio name: Hospital de La Princesa name: University Hospital Virgen de las Nieves name: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau name: Germans Trias i Pujol Hospital name: Hospital Universitario de Navarra name: Hospital Universitario de Jerez de la Frontera name: Hospital El Bierzo name: Hospital Clinico Universitario San Cecilio name: Hospital Universitario Donostia name: Hospital Universitario Central de Asturias name: Hospital Universitario de la Ribera name: Hospital Costa del Sol name: Hospital General Universitario Dr. Balmis name: Hospital de Sagunto name: Hospital Lluis Alcanyís de Xàtiva name: Hospital Universitario Lucus Augusti name: Hospital del Mar name: Hospital Clínico Universitario Virgen de la Arrixaca name: Hospital Clinic of Barcelona briefSummary: The main objective is to estimate the annual symptomatic incidence of Bordetella pertussis and RSV infections in patients aged 18 years and over with asthma, which will be identified by PCR, for Bordetella pertussis and by PCR for RSV performed at a specific timepoint from onset of symptoms for each symptomatic Acute Respiratory Infection (ARI). |
A multicentre prospective cohort study will be undertaken in Spain. Thirty-five centres from different autonomous communities in Spain will participate in the study. |
Participants will be asked to report to the investigator if they experience an asthma exacerbation or symptoms of acute respiratory infection with 2 years follow up conditions: Asthma conditions: Pertussis conditions: RSV Infection studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 784 type: ESTIMATED name: PCR measure: Incidence of Bordetella pertussis and RSV infections in adult patients with asthma, measure: To describe the seroprevalence of Bordetella pertussis in adult patients with asthma measure: To describe the seroprevalence of RSV in adult patients with asthma measure: To evaluate the severity and control of the asthma caused by either BP or RSV infection sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital Clínico Universitario de Santiago de Compostela status: RECRUITING city: Santiago De Compostela state: A Coruña zip: 15706 country: Spain name: Francisco Javier González Barcala, Ph.D. role: CONTACT email: francisco.javier.gonzalez.barcala@sergas.es lat: 42.88052 lon: -8.54569 hasResults: False |
<|newrecord|> nctId: NCT06285994 id: SRB2024016 briefTitle: Complications of High Frequency Jet Ventilation overallStatus: RECRUITING date: 2024-04-20 date: 2024-08-31 date: 2024-10-31 date: 2024-02-29 date: 2024-04-24 name: Erasme University Hospital class: OTHER briefSummary: High frequency jet ventilation (HFJV) has been introduced in 1967 as technique allowing ventilation with simultaneous access to the airway for bronchoscopy. Continuous improvement in the technique has led to a large use during interventional bronchoscopy, especially in large centers. However, complications occuring during the use of HFJV are poorly known. In this retrospective cohort study, the charts of all patients who had a bronchoscopy with the use of HFJV between 2019 and 2023 in our hospital will be analyzed. Primary outcome will the description of all complications during HFJV. Complications are defined as: |
* Hypoxia: SpO2 \< 90% for 1 min |
* Severe hypoxia: SpO2 \< 85% for 1 min |
* Hemodynamic instability, defined as Arterial pressure \< 90/60 |
* Cardiac arrhythmia |
* Laryngospasm or bronchospasm |
* Barotrauma or volutrauma |
* Need for ICU admission |
A model predicting the risk for developing any complication will be developped using 2 mathematical methods: |
* a multivariate analysis |
* a data mining approach |
For both approaches, the following variables will be included in the model: |
* Age |
* Gender |
* Weight |
* Height |
* BMI |
* Smoking |
* Alcohol consumption |
* Consumption of Other drugs |
* ASA class |
* Obstructive pulmonary disease |
* Restrictive lung disease |
* COPD status (1, 2, 3, 4) |
* Interstitial lung disease |
* Lung tumor |
* Trachea location |
* Carina location |
* Bronchial location |
* Pulmonary or tracheal stenosis |
* Presence of stridor |
* Severe stenosis (\< 6 mm) |
* Baseline SpO2 (pre-intervention) |
* Pre-intervention oxygen requirement Procedure |
* Duration (min) |
* Stent placement |
* Dilation |
* Laser treatment |
* Length of hospital stay Lung function tests |
* FEV1 (forced expiratory volume) |
* VC (Vital Capacity) |
* FEV1/VC (Tiffeneau ratio) |
* CPT (total lung capacity) |
* DLCO (carbon monoxide diffusion) conditions: High-Frequency Jet Ventilation conditions: Bronchoscopy studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 1200 type: ESTIMATED name: High frequency jet ventilation measure: Occurence of complications measure: Prediction model of complications sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hôpital Universitaire de Bruxelles - Hôpital erasme status: RECRUITING city: Brussels zip: 1070 country: Belgium name: Denis Schmartz, MD role: CONTACT phone: +3225553919 email: denis.schmartz@hubruxelles.be lat: 50.85045 lon: 4.34878 hasResults: False |
<|newrecord|> nctId: NCT06285981 id: OCI_2206 briefTitle: Retrospective Study Chimaera Long Nail in Adult Patient overallStatus: RECRUITING date: 2023-11-27 date: 2024-06-30 date: 2024-06-30 date: 2024-02-29 date: 2024-04-12 name: Orthofix s.r.l. class: INDUSTRY briefSummary: The CHIMERA study intends to evaluate the clinical benefits of the study medical device in the standard clinical practice. conditions: Pertrochanteric Fracture of Femur conditions: Intertrochanteric Fracture of Femur conditions: Subtrochanteric Fracture of Femur studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 44 type: ESTIMATED name: Chimaera Long Nail measure: percent of patients in wich bone union has been achieved measure: percent of patients that required a reoperation sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: AORN Sant'Anna e San Sebastiano status: NOT_YET_RECRUITING city: Caserta state: CE zip: 81100 country: Italy name: Gaetano Bruno role: CONTACT phone: 0823 232111 lat: 41.07262 lon: 14.33231 facility: Craeggi Hospital status: RECRUITING city: Florence state: FI zip: 50134 country: Italy name: Roberto Civinini role: CONTACT phone: 055 794 111 lat: 43.77925 lon: 11.24626 hasResults: False |
<|newrecord|> nctId: NCT06285968 id: AAAU8937 id: P50MD017341 type: NIH link: https://reporter.nih.gov/quickSearch/P50MD017341 briefTitle: The DREAM Study: A Multidimensional Sleep Health Intervention for Reducing Cardiometabolic Health Inequities overallStatus: RECRUITING date: 2024-03-12 date: 2026-03-31 date: 2027-03-31 date: 2024-02-29 date: 2024-03-28 name: Columbia University class: OTHER name: National Institute on Minority Health and Health Disparities (NIMHD) briefSummary: The purpose of this randomized controlled trial is to evaluate the impact of a multidimensional sleep health promotion intervention on blood pressure, glycemic control indicators, anthropometric markers of adiposity, and lifestyle factors in Hispanic/Latina/o/x adults. Participants will be randomized into an intervention or a control group. The control arm will receive standard Life's Essential 8 cardiovascular health educational materials. The intervention arm will additionally receive a multi-component intervention aimed at improving sleep health based on evidence-based sleep hygiene education and established behavior change techniques that include personalized sleep health feedback, goal setting and establishing a sleep health plan, coaching, self-monitoring, and addressing light and noise in the sleep environment. Mixed methods will be used to understand implementation determinants, processes, and outcomes, ensuring the successful completion and future expansion of this intervention. conditions: Blood Pressure studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 250 type: ESTIMATED name: Multidimensional Sleep Health Promotion Intervention measure: Change in office systolic blood pressure measure: Change in office systolic blood pressure (sustained effect at 24 weeks) measure: Change in office diastolic blood pressure measure: Change in out-of-office blood pressure measure: Change in fasting glucose measure: Change in body weight measure: Change in waist circumference measure: Change in diet quality measure: Change in sleep health measure: Acceptability of Implementation measure: Feasibility of Implementation measure: Appropriateness of Implementation sex: ALL minimumAge: 30 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Columbia University Irving Medical Center, Mailman School of Public Health status: RECRUITING city: New York state: New York zip: 10032 country: United States name: Nour Makarem, PhD role: CONTACT email: nm2968@cumc.columbia.edu lat: 40.71427 lon: -74.00597 hasResults: False |
<|newrecord|> nctId: NCT06285955 id: 307-reinforced teeth briefTitle: Clinical Trial of Metal-Reinforced Teeth Designed for Endoscopic Clips overallStatus: RECRUITING date: 2024-01-15 date: 2024-07-31 date: 2024-08-31 date: 2024-02-29 date: 2024-02-29 name: Beijing 302 Hospital class: OTHER briefSummary: Postoperative gastrointestinal complications following ESD, EMR, and EFTR procedures, such as gastrointestinal bleeding, diverticula, fistulas, perforations, and stent fixation, can be effectively treated through gradual endoscopic procedures. The technical limitations of traditional endoscopic hemoclips restrict their application. Although endoscopic suturing techniques are emerging, most are still in the exploratory phase. Therefore, the investigators have developed metal-reinforced teeth for hemoclips. This initial clinical study aims to validate the safety, feasibility, and effectiveness of reinforced teeth in clinical applications. The investigators also aim to explore the uses and limitations of this technology. The primary outcomes are the technical success rate and the clinical success rate. conditions: Pilot Study conditions: Clips studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 10 type: ESTIMATED measure: Clinical success rate measure: Technical success rate measure: Delayed bleeding rate measure: Delayed perforation rate sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The fifth Medical Center of Chinese PLA General Hospital status: RECRUITING city: Beijing state: Beijing zip: 100071 country: China name: Jindong Chu, MD role: CONTACT phone: +8615811201126 email: chu465292278@163.com name: Shuqian Hu role: CONTACT phone: +8618526504112 email: 1811045@mail.nankai.edu.cn name: Yan Liu, MD role: PRINCIPAL_INVESTIGATOR lat: 39.9075 lon: 116.39723 hasResults: False |
<|newrecord|> nctId: NCT06285942 id: 277.535 id: CE366/2023 type: REGISTRY domain: CET AOU Maggiore della Carità di Novara briefTitle: EdOxaban in fRagIle Patients With Percutaneous Endoscopic GAstrostoMy and atrIal fIbrIllation acronym: ORIGAMI II overallStatus: RECRUITING date: 2024-02-01 date: 2025-01-31 date: 2025-01-31 date: 2024-02-29 date: 2024-02-29 name: Azienda Ospedaliero Universitaria Maggiore della Carita class: OTHER briefSummary: The goal of this interventional study is to describe the use of Edoxaban via PEG in patients with an indication to anticoagulation therapy. One arm will receive Edoxaban through PEG and the other arm will receive other Direct oral anticoagulants through PEG or subcutaneous heparin or LMWH. |
Once enrolled, patients will be treated with a single daily dose of Edoxaban (60 or 30 mg according to specific indications). At day 4 after enrollment (steady state), evaluation of anti-FXa activity and thrombin generation assay will be performed on peripheral whole blood samples. At months 6 and 12 patients will be asked to complete the ACTS (Anti-Clot treatment scale) questionnaire specific for anticoagulation. |
The main endpoint will be: the difference in the results of the Anti-Clot treatment scale questionnaire between the two groups evaluated at 12 months. conditions: Atrial Fibrillation conditions: Fragility studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE maskingDescription: An interim-analysis will be performed on the primary endpoint when at least 50% of patients will have been randomized and completed the 6 months follow-up. The interim-analysis will be performed by an independent statistician, blinded for the treatment allocation. The statistician will report to the independent data and safety monitoring board whoMasked: OUTCOMES_ASSESSOR count: 168 type: ESTIMATED name: Edoxaban name: No Edoxaban measure: Difference in Anti-Clot treatment scale (ACTS) questionnaire results among the two groups assessed at 6 and 12 months. measure: Number of cardio-embolic events at 6 and12 months measure: Number of bleeding events measure: Assessment of drugs efficacy by measuring the anti-factor Xa activity measure: Assessment of drugs efficacy by measuring the thrombin generation measure: Assess the quality of life measure: Cost-effectiveness analysis sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ospedale Policlinico San Martino status: RECRUITING city: Genova zip: 16132 country: Italy name: Pietro Ameri, Prof role: CONTACT phone: +39 010 3538975 email: pietro.ameri@unige.it lat: 44.40478 lon: 8.94438 facility: AOU Maggiore della Carità status: RECRUITING city: Novara zip: 28100 country: Italy name: Domenico D'Amario, Prof role: CONTACT phone: 0039 0321 3733141 email: domenico.damario@uniupo.it lat: 45.44694 lon: 8.62118 facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS status: RECRUITING city: Roma zip: 00168 country: Italy name: Cristiano Spada, Prof role: CONTACT phone: 06 30151 email: cristiano.spada@policlinicogemelli.it lat: 41.89193 lon: 12.51133 hasResults: False |
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