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In addition to intravenous medications, various neuraxial and peripheral nerve blocks can be used in cardiac surgery. In recent years, thoracic epidural analgesia has been avoided due to the use of intraoperative high-dose heparin. As an alternative, peripheral nerve blocks have recently gained popularity. SAPB is one of them. SAPB can be applied in three ways. While deep SAPB (DSAPB) is applied under the serratus anterior muscle, superficial SAPB (SSAPB) is applied above the serratus anterior muscle. Combined SAPB (CSAPB) is applied both below and above the serratus anterior muscle. These blocks can be performed with a single injection anywhere between the second and seventh ribs on the lateral chest wall.
In this study, the analgesic effects of ultrasound-guided CSAPB application in patients undergoing MICS will be evaluated. conditions: Serratus Anterior Plane Block conditions: Acute Pain conditions: Postoperative Analgesia conditions: Minimal Invasive Cardiac Surgery studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: Combined SAPB measure: Pain Scores measure: Pain Scores measure: Pain Scores measure: Pain Scores measure: Pain Scores measure: Remifentanyl Consumption sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ankara City Hospital status: RECRUITING city: Çankaya state: Ankara zip: 06290 country: Turkey name: Emine N Zengin, MD role: CONTACT phone: +905063370548 email: nilbavullu@gmail.com lat: 39.9179 lon: 32.86268 hasResults: False
<\|newrecord\|> nctId: NCT06326307 id: 247-05-21 briefTitle: Effectiveness of Puppet Modeling Technique on Children Undergoing Stressful Dental Procedures overallStatus: COMPLETED date: 2023-01-01 date: 2023-12-01 date: 2023-12-01 date: 2024-03-22 date: 2024-03-22 name: King Abdulaziz University class: OTHER briefSummary: The goal of this RCT is to compare puppet modeling technique vs tell show and do on children undergoing stressful dental procedures'
* The main question\[s\] it aims to answer are:
1. To compare the effect of puppet modeling vs tell show and do on the cooperation of children during the administration of local anesthesia.
2. To compare the effect of puppet modeling vs tell show and do on the anxiety level of children during the administration of local anesthesia.
type of study: clinical trial participant population/health conditions: Healthy
In this randomized crossover clinical trial, study subjects were randomly allocated into two groups:
* Group I : Children who received puppet behavior guidance during their first visit and tell-show-do guidance in their second visit, 2 weeks later. (P-TSD)
* Group II : Children who received the tell-show-do behavior guidance during their first visit and puppet behavioral guidance in their second visit, 2 weeks later.(TSD-P) conditions: Behavioral Guidance in Pediatric Dentistry studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: * Group I : Children who received puppet behavior guidance during their first visit and tell-show-do guidance in their second visit, 2 weeks later. (P-TSD)
* Group II: Children who received the tell-show-do behavior guidance during their first visit and puppet behavioral guidance in their second visit, 2 weeks later.(TSD-P) primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Two evaluators, who are blinded to the experimented techniques, watched recorded videos of both groups separately and gave their behavior assessment. whoMasked: OUTCOMES_ASSESSOR count: 41 type: ACTUAL name: Tell Show and Do Guidance name: Puppet Guidance measure: Heart rate measure: Facial Image Scale measure: Vehnam Anxiety Rating Scale measure: Frankl behavior rating scale measure: FLACC Pain scale measure: Venham Scale of Dental behavior sex: ALL minimumAge: 3 Years maximumAge: 8 Years stdAges: CHILD facility: King Abulaziz university dental hospital city: Jeddah state: Makkah zip: 21589 country: Saudi Arabia lat: 21.54238 lon: 39.19797 hasResults: False
<\|newrecord\|> nctId: NCT06326294 id: 727/CNBS/23 briefTitle: Assessment of the Effectiveness of TA Versus LEEP for Cervical Cancer Risk Reduction in WLHIV in Mozambique overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2027-09 date: 2027-12 date: 2024-03-22 date: 2024-03-22 name: Instituto Nacional de Saúde, Mozambique class: OTHER_GOV name: M.D. Anderson Cancer Center briefSummary: Given that WLWH are more likely to develop persistent HPV infection and CC, effective screening and the management and treatment of pre-cancerous cervical abnormalities is critical to decrease the global burden of cervical cancer. The vast majority of WLWH live in SSA, where resources are more constrained. Therefore, simple, affordable, and effective tools are needed for the prevention of cervical cancer in SSA. In this setting, the best method for treatment of screen-positive WLWH has not been determined. The proposed study will compare the effectiveness of TA vs. LEEP, for treating precursor lesions (CIN 2/3) and HPV infection in WLWH, identify the determinants of treatment failure, and develop a strategy to predict patients in whom treatment is likely to fail so that alternative treatments can be provided. Moreover, local evidence of the optimal method of treatments is necessary to inform health policy and promote adherence. conditions: HIV Infections conditions: HPV Infection conditions: CIN 2/3 studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: To compare TA, an ablative cervical treatment modality, and LEEP, an excisional cervical treatment modality, in screen-positive WLWH patients, for eradication of hrHPV and effectiveness of treating biopsy-confirmed CIN 2/3. primaryPurpose: TREATMENT masking: NONE count: 4844 type: ESTIMATED name: Thermal ablation name: LOOP ELECTROSURGICAL EXCISION PROCEDURE measure: Comparison of treatment success rates for biopsy-confirmed CIN 2/3: Thermoablation (TA) vs. Loop Electrosurgical Excision Procedure (LEEP) sex: FEMALE minimumAge: 25 Years maximumAge: 49 Years stdAges: ADULT facility: INSMozambique city: Maputo country: Mozambique lat: -25.96553 lon: 32.58322 hasResults: False
<\|newrecord\|> nctId: NCT06326281 id: ACHBILKENT-ANEST-BK-01 briefTitle: Postoperative Pain Management in Laparoscopic Cholecystectomies overallStatus: COMPLETED date: 2023-07-01 date: 2024-02-22 date: 2024-02-28 date: 2024-03-22 date: 2024-03-22 name: Ankara City Hospital Bilkent class: OTHER briefSummary: This study is to demonstrate the effectiveness of external oblique intercostal plane block, a new block method, in the treatment of postoperative pain occurring after laparoscopic cholecystectomy operations, which are frequently and widely performed today.
It aims to add new applications to multimodal analgesia methods, which provide the greatest contribution to the early recovery process after surgery, and to contribute to the early recovery process by increasing patient satisfaction. conditions: Cholecystitis/Cholelithiasis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Evaluation of postoperative pain in 4 groups in laparoscopic cholecystectomy with control group primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Patients were not told which method would be used The person evaluating the patients did not know which method was applied to which patient. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 100 type: ACTUAL name: external oblique intercostal plane block group name: oblique subcostal TAP block group name: Local anesthetic infiltration group name: control group measure: Visual Analogue Scale Score sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ankara Bılkent City Hospital city: Ankara zip: 06100 country: Turkey lat: 39.91987 lon: 32.85427 hasResults: False
<\|newrecord\|> nctId: NCT06326268 id: 2023-019 id: 2023-A02133-42 type: OTHER domain: ID-RCB Number briefTitle: Interest of Light Therapy in Hematology - The PHOTO-TREAT Study acronym: PHOTO-TREAT overallStatus: RECRUITING date: 2024-04-17 date: 2025-09-17 date: 2025-09-17 date: 2024-03-22 date: 2024-04-22 name: Institut de cancérologie Strasbourg Europe class: OTHER briefSummary: Chemo-induced mucositis is a common complication in patients treated for hematologic malignancies. They can manifest itself as a simple local irritation with erythema and inflammation but can also progress to erosions and ulcerations of the entire oral mucosa and are also responsible for an increased risk of infection in these immunocompromised patients.
The only therapies currently offered are local care and intravenous analgesics. Studies in pediatric hematology show the effectiveness of prevention and low-dose laser treatment in chemo-induced mucositis, both in terms of reducing the number of mucositis developed but also in terms of reducing the grade of mucositis. This currently results in a recommendation for the use of photobiomodulation by international bodies such as ESMO (European Society for Medical Oncology). conditions: Leukemia, Myeloid, Acute conditions: Lymphoma studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 30 type: ESTIMATED name: Phototherapy system CareMin650TM measure: Evaluate the impact of Photobiomodulation (PBM) therapy in the management of chemo-induced mucositis in terms of prevalence of mucositis measure: Evaluate the impact of PBM in the management of chemo-induced mucositis in terms of reduction in analgesic consumption. measure: Evaluate the impact of PBM in terms of infection by bacterial translocation risk reduction. measure: Evaluate the impact of PBM in terms of reduction of the use of artificial feeding. measure: Evaluate the impact of PBM in terms of reduction of the length of hospital stay. measure: Evaluate the impact of PBM in terms of reduction of the number of transfusions. measure: Evaluate the impact of PBM in terms of pain reduction measure: Evaluate the impact of PBM on patient's satisfaction regarding pain management during hospital stay sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Institut de cancérologie Strasbourg Europe status: RECRUITING city: Strasbourg zip: 67033 country: France role: CONTACT phone: (0)3 68 33 95 23 phoneExt: +33 email: promotion-rc@icans.eu name: Anne ZILLIOX, MD role: PRINCIPAL_INVESTIGATOR lat: 48.58392 lon: 7.74553 hasResults: False
<\|newrecord\|> nctId: NCT06326255 id: LYASD briefTitle: Feasibility and Acceptability of Laughter Yoga in Children With Autism Spectrum Disorder and Their Parents overallStatus: NOT_YET_RECRUITING date: 2024-03-15 date: 2024-10-01 date: 2025-12-31 date: 2024-03-22 date: 2024-03-22 name: The Hong Kong Polytechnic University class: OTHER briefSummary: This is a pilot randomised controlled trial to explore the acceptability and feasibility of laughter yoga about anxiety and depression reduction in children with ASD and parenting stress reduction for their parents. Hypotheses of this study include:
1. Laughter yoga is acceptable to children with ASD and their parents.
2. Laughter yoga is feasible for anxiety and depression reduction in children with ASD and parenting stress reduction in their parents.
3. Participants in the experimental group will have significantly more reduction in depression, anxiety and parental stress than those in the wait-list-control group. conditions: Autism Spectrum Disorder conditions: Parenting Stress conditions: Depression conditions: Anxiety studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 66 type: ESTIMATED name: laughter yoga measure: Response rate measure: Attrition rate measure: Attendance rate measure: Perception on laughter yoga measure: Difficulties in laughter yoga measure: Safety issues measure: Depression measure: Anxiety measure: Parenting Stress measure: Child-parent Relationships sex: ALL minimumAge: 8 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: The Hong Kong Polytechnic University city: Hong Kong country: Hong Kong lat: 22.27832 lon: 114.17469 hasResults: False
<\|newrecord\|> nctId: NCT06326242 id: IEO 1648 briefTitle: What Unmet Need for the Patients?A Focus on the Social Determinants of Health in Phase 1 Clinical Trials overallStatus: RECRUITING date: 2023-03-27 date: 2024-12-31 date: 2024-12-31 date: 2024-03-22 date: 2024-03-22 name: European Institute of Oncology class: OTHER briefSummary: An observational prospective study of patients enrolled and treated with experimental drugs in Phase I studies. conditions: Solid Tumor studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: Solid Tumor measure: The geographical accessibility of patients attending the Phase 1 facility of the European Institute of Oncology (IEO). measure: The characterization of enrolled patients involves assessing their participation in clinical trials measure: The characterization of enrolled patients based on therapeutic compliance. measure: The protocol prescriptions in relation to socioeconomic and geographical determinants. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: European Institute of oncology status: RECRUITING city: Milano zip: 20141 country: Italy name: Teresa Profeta role: CONTACT phone: +390294372561 lat: 45.46427 lon: 9.18951 hasResults: False
<\|newrecord\|> nctId: NCT06326229 id: CEIm 3096 briefTitle: Clinical Validation of Musculoskeletal ICF Core Set in Primary Care Physiotherapy overallStatus: NOT_YET_RECRUITING date: 2024-05-06 date: 2025-01-31 date: 2025-09-26 date: 2024-03-22 date: 2024-04-05 name: University of Valladolid class: OTHER name: Castilla-León Health Service briefSummary: The aim of this observational study is to validate the content of a tailored ICF core set for the management of musculoskeletal conditions in primary care physiotherapy services.
The main question it aims to answer is:
- Are the ICF entities included in the ICF Core Set under evaluation useful from a clinical point of view?
Participants will evaluate the relevance of each ICF entity included in the ICF core set according to their musculoskeletal condition. conditions: Musculoskeletal Diseases studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 385 type: ESTIMATED name: ICF entities assessment measure: ICF core set for post-acute musculoskeletal conditions (adapted version for primary care physiotherapy services) measure: Sociodemographic data of the sample sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ólvega Primary Care Physiotherapy service city: Ólvega state: Soria zip: 42110 country: Spain name: Héctor Hernández Lázaro, PhD role: CONTACT phone: +34976645480 phoneExt: 38229 email: hhernandezl@saludcastillayleon.es lat: 41.77901 lon: -1.98391 hasResults: False
<\|newrecord\|> nctId: NCT06326216 id: 19-011292 id: NCI-2023-05221 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: 19-011292 type: OTHER domain: Mayo Clinic Institutional Review Board briefTitle: Determination of Baseline Levels for Prostate Cancer-Derived Extracellular Vesicles Following Local Treatment of Prostate Cancer overallStatus: RECRUITING date: 2020-06-10 date: 2025-07-01 date: 2025-07-01 date: 2024-03-22 date: 2024-03-22 name: Mayo Clinic class: OTHER briefSummary: This study is being done to determine whether levels of prostate cancer derived extracellular vesicles from blood and urine specimens correlate with response to primary local treatment (surgery) in prostate cancer. conditions: Prostate Carcinoma studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: Non-Interventional Study measure: Levels of prostate cancer-derived extracellular vesicles (EVs) - radical prostatectomy measure: Levels of prostate cancer-derived extracellular vesicles (EVs) - negative controls measure: Correlation between prostate specific antigen (PSA) levels and prostate cancer-derived EVs measure: Prostate cancer-derived EV levels sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mayo Clinic in Rochester status: 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: Eugene D. Kwon, M.D. role: PRINCIPAL_INVESTIGATOR lat: 44.02163 lon: -92.4699 hasResults: False
<\|newrecord\|> nctId: NCT06326203 id: UPECLIN-MB-8 briefTitle: Cell Therapy for Lower Limb Ulcers in Patients With Critical Limb Ischemia overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2027-07-01 date: 2027-12-31 date: 2024-03-22 date: 2024-04-10 name: UPECLIN HC FM Botucatu Unesp class: OTHER name: Conselho Nacional de Desenvolvimento Científico e Tecnológico briefSummary: Peripheral arterial disease (PAD) can progress to critical limb ischemia (CLI) of the affected lower limb, characterized by pain at rest, ulcerations or gangrene, with a high risk of amputation. In this phase, the best treatment is arterial limb revascularization, but this is not always possible or even effective for promoting pain relief, healing of ulcers or preventing amputations, in addition to the high socioeconomic cost caused by the disease. Recent advances in cell therapy represent a promising supporting alternative for the treatment of PAD in cases where conventional alternatives have run out. Objective: To evaluate the safety and efficacy of cell therapy with expanded autologous mesenchymal stem cells in the treatment of patients with PAD with CLI and chronic arterial ulcers. Methods: An open randomized clinical study will be performed with 2 groups of 20 patients with CLI: in group 1, a fragment of abdominal fat tissue (10g) will be collected to obtain mesenchymal stem cells, which will be expanded and applied using subcutaneous perilesional injection in the affected lower limb, in addition to the application in the form of a personalized curative biological on the wounds. Group 2 will receive conventional treatment with a Hydrogel dressing with essential fatty acids. Periodic clinical evaluations, complementary exams and photographic record will be carried out. The main outcome of effectiveness will be partial or total wound healing. Safety outcomes will be monitored for infections, gangrene, amputations and deaths. Participants will be monitored for 120 days. Major amputation cases will not be included. An independent external evaluator and blind to the groups will evaluate the results. It is an innovative procedure with high impact and financial return for SUS, in view of the high prevalence of the disease and the high socioeconomic impact of the disease when it progresses to limb amputation. conditions: Peripheral Arterial Disease conditions: Leg Ulcer studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: CELULAS TRONCO name: CONVENTIONAL DRESSING measure: Major Amputation measure: Ulcer Healing sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06326190 id: EORTC-2334-BTG briefTitle: 177Lu-DOTATATE for Recurrent Meningioma acronym: LUMEN-1 overallStatus: NOT_YET_RECRUITING date: 2024-11-06 date: 2027-04-14 date: 2028-12-22 date: 2024-03-22 date: 2024-03-22 name: European Organisation for Research and Treatment of Cancer - EORTC class: NETWORK name: Novartis briefSummary: Novel treatments are urgently needed for meningiomas progressing after local therapies (surgery, radiotherapy). So far, no effective systemic therapies are known in this situation. The LUMEN-1 trial will investigate in a prospective randomized trial the efficacy of the precision medicine "theranostic" concept of combining diagnostic patient selection using PET-based molecular imaging and target-specific therapeutic intervention using a systemically administered radioligand.
The rationale for the LUMEN-1 trial is based on the following: (a) high somatostatin receptor (SSTR) expression in meningiomas, (b) wide-spread availability of clinically established SSTR-PET imaging, (c) proven efficacy of SSTR-targeting radioligand therapy using \[177Lu\]Lu-DOTATATE in another tumor type (neuroendocrine tumors), and (d) promising experiences with \[177Lu\]Lu-DOTATATE therapy in compassionate use applications and retrospective case series and interim results from one ongoing uncontrolled prospective trial in meningiomas. LUMEN-1 is the first randomized clinical trial to investigate \[177Lu\]Lu-DOTATATE therapy in refractory meningioma and may open new avenues for treatment and research in this area. conditions: Recurrent Meningioma studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 135 type: ESTIMATED name: Local standard of Care name: 177Lu-DOTATATE measure: Progression Free Survival (PFS) measure: Overall Survival (OS) measure: Radiological response rate measure: Radiological response rate measure: The magnitude of change in Health-related quality of life (HRQoL) measure: The magnitude of change in Health-related quality of life (HRQoL) measure: The magnitude of change in Health-related quality of life (HRQoL) measure: Neurological function (NANO scale) measure: Toxicity According to CTCAE Version 5.0 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06326177 id: Yeditepe U - Poyraz Tuncer briefTitle: Investigating Association Between Spine, Scapular, Shoulder and Core in Swimmers overallStatus: ENROLLING_BY_INVITATION date: 2024-06-15 date: 2024-07-01 date: 2024-09-01 date: 2024-03-22 date: 2024-03-27 name: Yeditepe University class: OTHER briefSummary: The aim of this observational study is to investigate relationship between cervical, thoracic, lumbar and thoracolumbar spine posture, spine movement, isometric and eccentric shoulder strength, scapular dyskinesis and core muscle endurance in healthy competitive young swimmers in comparison with healthy recreational swimmers. The main question is whether spine posture affects spine movement, shoulder strength, scapular dyskinesia and core endurance. Participants will asked to complete a warm up period, after that spine posture, spine movement, scapular dyskinesia, shoulder strength and core endurance will be assessed by examiner. Researchers will compare competitive swimmer group and recreational swimmer group. Additionally correlation between spine posture, spine movement, scapular dyskinesia, shoulder strength and core muscle endurance will be investigated in competitive swimmer group. Aim of the study is to determine whether posture have any effect upon these parameters. conditions: Postural Kyphosis conditions: Postural Lordosis conditions: Movement, Abnormal conditions: Spine Injury conditions: Cervical Lordosis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 44 type: ESTIMATED name: Spine Posture Assessment name: Spine Movement Assessment name: Core Muscle Endurance Assessment name: Scapular Dyskinesia name: Shoulder Strength measure: Spinal Posture measure: Cervical Movement measure: Thoracic Movement measure: Lumbar Movement measure: Thoracolumbar Movement measure: Anterior Core Musculature Assessment measure: Lateral Core Musculature Assessment measure: Posterior Core Musculature Assessment measure: Core Musculature Ratio Assessment measure: Shoulder Strength Assessment measure: Shoulder Strength Ratio Assessment measure: Scapular Dyskinesia sex: ALL minimumAge: 12 Years maximumAge: 24 Years stdAges: CHILD stdAges: ADULT facility: PT Academy city: Istanbul state: Kadıköy zip: 34744 country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False
<\|newrecord\|> nctId: NCT06326164 id: sample briefTitle: Effect of Kinesio-taping of Lower Limbs overallStatus: RECRUITING date: 2024-02-15 date: 2024-06-15 date: 2024-07-18 date: 2024-03-22 date: 2024-03-22 name: Kafrelsheikh University class: OTHER briefSummary: The goal of this clinical trail is to test if kinesio-taping on lower limbs has an effect on balance and gait in children with diplegic cerebral palsy. Children in study group will have designed physiotherapy for gait and balance, the control group will have designed physiotherapy in addition to kinesio-taping on both lower limbs. conditions: Cerebral Palsy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: kinesio-taping. name: A designed physiotherapy program. measure: Change in gait. measure: Change in balance. sex: ALL minimumAge: 6 Years maximumAge: 10 Years stdAges: CHILD facility: Asmaa Mohamed Khalil Sedeek status: RECRUITING city: Kafr Ash Shaykh country: Egypt name: asmaa M khalil role: CONTACT phone: 01101011588 email: asmaakhalil011010@gmail.com lat: 31.11174 lon: 30.93991 hasResults: False
<\|newrecord\|> nctId: NCT06326151 id: UMAPS-UDATO briefTitle: Interdisciplinary Psychoeducational Intervention Programme for Caregivers of Dependent Older Adults overallStatus: NOT_YET_RECRUITING date: 2024-09-01 date: 2025-09-01 date: 2025-12-31 date: 2024-03-22 date: 2024-03-22 name: University of Salamanca class: OTHER briefSummary: Background: Caring for an older dependent adult with cognitive impairment can have negative consequences for the family caregiver. Interdisciplinary interventions are necessary to address their needs jointly and comprehensively. While attempts have been made to improve their situation from different disciplines in isolation, a collaborative approach is required to ensure the best possible outcome.
Methods: A parallel, randomized, controlled clinical trial with two arms will be conducted at the Occupational Therapy Teaching and Care Unit (UDATO) and the Municipal Psychosocial Support Unit for the Elderly (UMAPS), both of which belong to the University of Salamanca and are in agreement with the City Council of Salamanca, Spain. The trial will also be conducted at the University Care Centre of Salamanca (CAUSA). People aged 60 years or older will be recruited as family caregivers of dependent older adults with cognitive impairment in a chronic situation. Participants will be divided into two groups: the intervention group (IG) will carry out an interdisciplinary psychoeducational programme from the perspective of psychology and occupational therapy, and the control group (CG) will carry out a controlled follow-up. Participants will complete 12 sessions over a period of 3 months, followed by three monthly reinforcement sessions after the intervention. At the beginning and end of the intervention, participants will be assessed and socio-demographic data will be collected along with the following scales: the Spanish version of the Caregiver Burden Interview (CBI), the Spanish version of the Center for Epidemiologic Studies-Depression Scale (CES-D), the Psychosocial Support Questionnaire adaptation (PSQ), the General Health Questionnaire (GHQ), the World Health Organization Quality of Life Assessment - AGE (WHOQOL-AGE) and the Bayer-Activities of Daily Living Scale (B-ADL).
Discussion: The objective of this study is to enhance conventional clinical practice for family caregivers of dependent older adults. This will be achieved through an interdisciplinary psychoeducational intervention that aims to reduce overload and depressive symptomatology, increase social support, improve health and perceived quality of life, and enhance understanding of the syndrome/illness. The intervention will also focus on managing difficult situations associated with day-to-day caregiving, managing emotions and associated erroneous beliefs, and promoting self-care. Additionally, the study aims to improve the functionality of the cared-for person. conditions: Dependent Older People conditions: Family Caregiver conditions: Interdisciplinary conditions: Intervention conditions: Occupational Therapy conditions: Psychoeducational conditions: Psychology studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE maskingDescription: The work of sequencing, randomisation, recruitment and allocation of the trial sample will be carried out by research staff who are not involved in the assessments or interventions of each group, thus avoiding any potential bias in the trial.
Participants will also be blinded and will not know which group they have been allocated to and therefore which intervention they will receive. In order to minimise any contamination between groups, the assessment process will be carried out by external research staff who will perform the measurements and who have been previously trained and educated to avoid subjective bias in the process, as they will be unaware of the intervention group to which they have been assigned, thus masking the blinded assessment by third parties in the clinical trial. In addition, the researchers responsible for the statistical analysis of the trial will be blinded in order to increase the rigour of the trial process and thus the scientific quality. whoMasked: OUTCOMES_ASSESSOR count: 70 type: ESTIMATED name: Interdisciplinary Psychoeducational Programme name: Health Education Programme measure: Mini Mental State Examination (MMSE) measure: Barthel Index measure: Caregiver Burden Interview measure: Centre for Epidemiological Studies Depression Scale measure: Adaptation of the Psychosocial Support Questionnaire measure: General Health Questionnaire measure: World Health Organization Assessment of Quality of Life - AGE (WHOQOL-AGE) measure: The Bayer-Activities of Daily Living Scale (B-ADL) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Eduardo Jose Fernandez Rodriguez city: Salamanca state: Castilla Y Leon zip: 37002 country: Spain name: Eduardo PhD Fernandez, PhD role: CONTACT phone: 923294500 email: edujfr@usal.es lat: 40.96882 lon: -5.66388 hasResults: False
<\|newrecord\|> nctId: NCT06326138 id: 22121 briefTitle: Pharmacokinetics and Pharmacodynamics of Edoxaban Before and After Bariatric Surgery acronym: EXPOSE overallStatus: WITHDRAWN date: 2024-03-11 date: 2024-03-11 date: 2024-03-11 date: 2024-03-22 date: 2024-03-22 name: Institut universitaire de cardiologie et de pneumologie de Québec, University Laval class: OTHER briefSummary: The study will be conducted at a single site in the Canada, Quebec. Participants will be recruited from the bariatric surgery clinic and will be required to be either, waiting for sleeve gastrectomy surgery (n=12, restrictive bariatric surgery, Group 1) or Roux-en-Y gastric bypass (n=12, mixed bariatric surgery, Group 1), or had underwent Roux-en-Y gastric bypass 12 ± 3 months ago (n=12, Group 2).
Participants in Group 1, edoxaban pharmacokinetic and pharmacodynamics will be evaluated before and 48 ± 5 hours after bariatric surgery (sleeve gastrectomy and Roux-en-Y gastric bypass). Participants in Group 2, edoxaban pharmacokinetic and pharmacodynamics will be evaluated only once, at 12 ± 3 months following their Roux-en-Y gastric bypass.
All participants will be received single oral doses of 60 mg edoxaban at each pharmacokinetic and pharmacodynamics evaluation. conditions: Bariatric Surgery Candidate studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Group 1: 12 patients waiting for a sleeve gastrectomy surgery and 12 patients waiting for a Roux-en-Y gastric bypass surgery.
Group 2: 12 patients 12 months after Roux-en-Y gastric bypass surgery. primaryPurpose: OTHER masking: NONE count: 0 type: ACTUAL name: Edoxaban Pharmacokinetics and Pharmacodynamics measure: Pharmacokinetics edoxaban parameter measure: Pharmacokinetics edoxaban parameter measure: Pharmacokinetics edoxaban parameter measure: Pharmacokinetics edoxaban parameter measure: Pharmacodynamics edoxaban parameter measure: Pharmacodynamics edoxaban parameter measure: Pharmacodynamics edoxaban parameter sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06326125 id: SherzadSH briefTitle: Pharmacology and Non-pharmacology Approaches in Reducing Children's Pain and Fear During Painful Procedures overallStatus: ENROLLING_BY_INVITATION date: 2023-12-15 date: 2024-04-10 date: 2024-04-10 date: 2024-03-22 date: 2024-03-28 name: Uppsala University class: OTHER briefSummary: This study Will contribute in the knowledge of pediatric nurses during painful procedures such venipuncture conditions: Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 160 type: ESTIMATED name: TICK-B name: TKTX-Cream name: TICK-B and TKTX-C measure: severity of Pain measure: Fear sex: ALL minimumAge: 6 Years maximumAge: 12 Years stdAges: CHILD facility: Sherzad Khudeida Suleman city: Duhok state: Erbil zip: 42012 country: Iraq lat: 36.86709 lon: 42.98845 hasResults: False
<\|newrecord\|> nctId: NCT06326112 id: 4588 briefTitle: Role of Active Deresuscitation After Resuscitation: acronym: RADAR-Canada overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-03-31 date: 2025-06-30 date: 2024-03-22 date: 2024-03-22 name: Unity Health Toronto class: OTHER name: Canadian Institutes of Health Research (CIHR) briefSummary: The RADAR-Canada trial is a pilot RCT undertaken to assess the acceptability of, compliance with, and biologic consequences of a deresuscitation protocol designed to expedite the removal of excess interstitial fluid in patients who remain in a positive fluid balance following admission to an intensive care unit (ICU). conditions: Fluid Overload conditions: Critical Illness conditions: Sepsis conditions: ARDS conditions: Trauma studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: RADAR-Canada is a parallel group CT in which study participants are randomized in a 1:1 ratio to protocolized deresuscitation or usual care primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Masking of the health care team will not be feasible as they must administer the intervention whoMasked: OUTCOMES_ASSESSOR count: 120 type: ESTIMATED name: Furosemide Injection name: Metolazone Tablets measure: Efficacy: Mean cumulative fluid balance measure: Compliance with deresuscitation protocol measure: Acceptability of protocol measure: All cause mortality measure: New onset organ dysfunction measure: Organ support-free days measure: Inflammatory and renal biomarkers - change from baseline values sex: ALL minimumAge: 18 Years maximumAge: 120 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Unity Health Toronto city: Toronto state: Ontario zip: M5B 1W8 country: Canada name: John C Marshall, MD role: CONTACT phone: 4168645225 email: john.marshall@unityhealth.to lat: 43.70011 lon: -79.4163 hasResults: False
<\|newrecord\|> nctId: NCT06326099 id: R34AA030655 type: NIH link: https://reporter.nih.gov/quickSearch/R34AA030655 briefTitle: Brief Binge Eating and Drinking Online Intervention overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-04-30 date: 2026-04-30 date: 2024-03-22 date: 2024-03-22 name: University of Southern California class: OTHER briefSummary: This pilot project targets both binge drinking and binge eating behavior in college students through a mobile-based online program that provides students with evidence-based intervention material designed to reduce the incidence of both behaviors and encourage students to seek more formal in-person counseling. conditions: Binge Eating conditions: Binge Drinking studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 300 type: ESTIMATED name: Brief Online Binge Eating and Drinking Intervention measure: Frequency of past 28-day binge drinking measure: Frequency of past 28-day binge eating measure: Brief Young Adult Alcohol Consequences Questionnaire (B-YAACQ) measure: Mental Health/Substance Use Disorder Treatment History Inventory sex: ALL minimumAge: 18 Years maximumAge: 24 Years stdAges: ADULT hasResults: False
<\|newrecord\|> nctId: NCT06326086 id: REC.65-080-7-1 briefTitle: Differences in Rate of Decline in CT-defined Skeletal Muscle Mass and Physical Performance in Patients With Advanced Non-small Cell Lung Cancer Receiving Chemotherapy and Targeted Therapy/Immunotherapy, Before and After Treatment. overallStatus: RECRUITING date: 2022-08-01 date: 2024-08-01 date: 2024-08-01 date: 2024-03-22 date: 2024-03-22 name: Prince of Songkla University class: OTHER briefSummary: Lung cancer is a common disease leading to 18 % of cancer deaths worldwide. Despite various improvement in treatment, there still remains low 5-year survival rate of 10-20 % in advanced lung cancer patients. Skeletal muscle mass and physical performance have been shown to effect overall survival and prognosis in lung cancer. This research focuses on effects of different treatment of lung cancer such as chemotherapy, targeted therapy and immunotherapy on skeletal muscle mass and physical performance. conditions: Advanced Lung Cancer conditions: Sarcopenia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 240 type: ESTIMATED name: Chemotherapy drug name: Targeted Agent name: Immunotherapy measure: To determine the differences in the rate of decline in CT defined skeletal muscle index at L3 vertebra and physical performance in advanced NSCLC patients receiving chemotherapy and targeted therapy/ immunotherapy, before and after treatment. measure: To determine validity of gender based cut off for CT-defined skeletal muscle index at L3 lumbar vertebra (L3SMI) based on recommendation of JSH/AWGS in Thai population. measure: 2. To determine baseline association between CT-defined skeletal muscle index at L3 lumbar vertebra (L3SMI) and physical performance using SPPB in advanced NSCLC patients. measure: 4. To determine differences in rate decline in skeletal muscle mass using CT-defined skeletal muscle index at L3 lumbar vertebra (L3SMI) in patients receiving first line chemotherapy (CMT) and other line chemotherapy (OCMT). sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Prince of Songkla University status: RECRUITING city: Hat Yai state: Songkla zip: 90110 country: Thailand lat: 7.00836 lon: 100.47668 hasResults: False
<\|newrecord\|> nctId: NCT06326073 id: OMUKAEK2019/324 briefTitle: Interaction Between Smoking, GCF Periostin, IL17A, IL17E and Non-surgical Periodontal Therapy overallStatus: COMPLETED date: 2019-07-01 date: 2021-02-01 date: 2021-07-01 date: 2024-03-22 date: 2024-03-22 name: Ondokuz Mayıs University class: OTHER briefSummary: It was aimed to evaluate the changes in the levels of Periostin, IL-17A and IL-17E cytokines in the gingival crevicular fluid (GCF) of periodontitis patients which non-surgical (Phase I) periodontal treatment applied to and their interactions with smoking. The study included systemic healthy smokers(SP)(n:11) and non-smokers(P)(n:11) with periodontitis, smokers (SS)(n:11) and non-smokers(S)(n:11) with periodontal healthy individuals Phase I periodontal treatment was applied to the groups with periodontitis. Before treatment (day 0), clinical measurements evaluating periodontal status were recorded and GCF samples were collected. GCF samples were collected from the same tooth regions on the 15th and 30th days after treatment and clinical measurements were repeated. GCF Periostin, IL-17A and IL-17E levels were determined by ELISA method. All data were evaluated statistically. conditions: Periodontitis conditions: Smoking studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The study included systemic healthy smokers(SP)(n:11) and non-smokers(P)(n:11) with periodontitis, smokers (SH)(n:11) and non-smokers(H)(n:11) with periodontal healthy individuals primaryPurpose: DIAGNOSTIC masking: NONE count: 44 type: ACTUAL name: Non Surgical Periodontal Treatment measure: Evaluation of Periostin levels measure: Evaluation of IL-17A levels measure: Evaluation of IL-17E levels measure: Interaction Between Smoking and GCF Periostin, IL17A, IL17E levels sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ondokuz Mayıs University Faculty of Dentistry Department of Periodontology city: Samsun zip: 55270 country: Turkey lat: 41.27976 lon: 36.3361 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2024-03-16 uploadDate: 2024-03-16T11:54 filename: Prot_SAP_000.pdf size: 206405 hasResults: False
<\|newrecord\|> nctId: NCT06326060 id: NN9541-5015 id: U1111-1291-9210 type: OTHER domain: World Health Organization (WHO) id: jRCT2051230198 type: REGISTRY domain: JRCT briefTitle: A Research Study Comparing How Well Different Doses of the Medicine NN0519-0130 Help People With Excess Body Weight Lose Weight overallStatus: RECRUITING date: 2024-03-18 date: 2024-11-25 date: 2025-05-05 date: 2024-03-22 date: 2024-04-18 name: Novo Nordisk A/S class: INDUSTRY briefSummary: This study will look at how a new medicine called NNC0519-0130 helps people with excess body weight lose weight. The study will test up to 6 different doses of NNC0519-0130. Participants will take 1-2 injections once a week. The study medicine will be injected under skin with a thin needle in the stomach, thigh, or upper arm. The study will last for about 42 weeks. conditions: Obesity studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: Sponsor staff involved in the clinical trial is masked according to company standard procedures. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 343 type: ESTIMATED name: NNC0519-0130 name: Placebo name: Tirzepatide measure: Relative change in body weight measure: Change in body weight measure: Achievement of greater than equal to (≥) 5% weight reduction measure: Achievement of ≥ 10% weight reduction measure: Achievement of ≥ 15% weight reduction measure: Achievement of ≥ 20% weight reduction measure: Change in body mass index (BMI) measure: Change in waist circumference measure: Change in glycated hemoglobin (HbA1c) measure: Change in fasting plasma glucose (FPG) measure: Change in systolic blood pressure (SBP) measure: Change in high sensitivity C-Reactive protein (hsCRP) measure: Change in total cholesterol measure: Change in high-density lipoprotein (HDL) cholesterol measure: Change in low-density lipoprotein (LDL) cholesterol measure: Change in triglycerides measure: Change in Impact of Weight on Quality of Life-Lite Clinical Trials (IWQOL-Lite-CT) Physical composite score measure: Change in IWQOL-Lite-CT Psychosocial composite score measure: Change in IWQOL-Lite-CT Physical Function score measure: Change in IWQOL-Lite-CT Total score measure: Number of adverse events sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Centricity Research-Arizona status: WITHDRAWN city: Mesa state: Arizona zip: 85206 country: United States lat: 33.42227 lon: -111.82264 facility: Arkansas Clinical Research status: WITHDRAWN city: Little Rock state: Arkansas zip: 72205 country: United States lat: 34.74648 lon: -92.28959 facility: Unity Health-Searcy Medical Center status: RECRUITING city: Searcy state: Arkansas zip: 72143 country: United States lat: 35.25064 lon: -91.73625 facility: FDRC status: RECRUITING city: Costa Mesa state: California zip: 92627 country: United States lat: 33.64113 lon: -117.91867 facility: Diablo Clinical Research, Inc. status: RECRUITING city: Walnut Creek state: California zip: 94598 country: United States lat: 37.90631 lon: -122.06496 facility: Univ of Colorado at Denver status: WITHDRAWN city: Aurora state: Colorado zip: 80045 country: United States lat: 39.72943 lon: -104.83192 facility: Nature Coast Clinical Research status: RECRUITING city: Crystal River state: Florida zip: 34429 country: United States lat: 28.90248 lon: -82.5926 facility: Northeast Research Institute status: RECRUITING city: Fleming Island state: Florida zip: 32003 country: United States lat: 30.0933 lon: -81.71898 facility: Jacksonville Ctr For Clin Res status: RECRUITING city: Jacksonville state: Florida zip: 32216 country: United States lat: 30.33218 lon: -81.65565 facility: Cedar-Crosse Research Center status: RECRUITING city: Chicago state: Illinois zip: 60607 country: United States lat: 41.85003 lon: -87.65005 facility: Midwest Inst For Clin Res status: RECRUITING city: Indianapolis state: Indiana zip: 46260 country: United States lat: 39.76838 lon: -86.15804 facility: Velocity Clin. Res Valparaiso status: RECRUITING city: Valparaiso state: Indiana zip: 46383 country: United States lat: 41.47309 lon: -87.06114 facility: L-MARC Research Center status: RECRUITING city: Louisville state: Kentucky zip: 40213 country: United States lat: 38.25424 lon: -85.75941 facility: Centennial Medical Group status: RECRUITING city: Columbia state: Maryland zip: 21045 country: United States lat: 39.24038 lon: -76.83942 facility: StudyMetrix Research LLC status: RECRUITING city: Saint Peters state: Missouri zip: 63303 country: United States lat: 38.80033 lon: -90.62651 facility: NYU Bariatric Surgical Ctr status: NOT_YET_RECRUITING city: New York state: New York zip: 10016 country: United States lat: 40.71427 lon: -74.00597 facility: Medication Mgmnt, LLC_Grnsboro status: RECRUITING city: Greensboro state: North Carolina zip: 27405 country: United States lat: 36.07264 lon: -79.79198 facility: PharmQuest Life Sciences LLC status: RECRUITING city: Greensboro state: North Carolina zip: 27408 country: United States lat: 36.07264 lon: -79.79198 facility: Physicians East Endocrinology status: RECRUITING city: Greenville state: North Carolina zip: 27834 country: United States lat: 35.61266 lon: -77.36635 facility: Piedmont Healthcare status: RECRUITING city: Statesville state: North Carolina zip: 28625 country: United States lat: 35.78264 lon: -80.8873 facility: Accellacare Wilmington status: RECRUITING city: Wilmington state: North Carolina zip: 28401 country: United States lat: 34.22573 lon: -77.94471 facility: Remington Davis Inc status: RECRUITING city: Columbus state: Ohio zip: 43215 country: United States lat: 39.96118 lon: -82.99879 facility: Family Practice Center of Wadsworth Inc. status: RECRUITING city: Wadsworth state: Ohio zip: 44281-9236 country: United States lat: 41.02561 lon: -81.72985 facility: Lynn Institute of Norman status: RECRUITING city: Norman state: Oklahoma zip: 73072 country: United States lat: 35.22257 lon: -97.43948 facility: The University of Penn Center status: RECRUITING city: Philadelphia state: Pennsylvania zip: 19104-3317 country: United States lat: 39.95233 lon: -75.16379 facility: Preferred Primary Care Physicians_Pittsburgh status: RECRUITING city: Pittsburgh state: Pennsylvania zip: 15243 country: United States lat: 40.44062 lon: -79.99589 facility: Velocity Clin Res Providence status: RECRUITING city: East Greenwich state: Rhode Island zip: 02818 country: United States lat: 41.66038 lon: -71.45589 facility: Medical University Of South Carolina status: NOT_YET_RECRUITING city: Charleston state: South Carolina zip: 29425 country: United States lat: 32.77657 lon: -79.93092 facility: Spartanburg Medical Research status: RECRUITING city: Spartanburg state: South Carolina zip: 29303 country: United States lat: 34.94957 lon: -81.93205 facility: Holston Medical Group Pc status: RECRUITING city: Bristol state: Tennessee zip: 37620-7352 country: United States lat: 36.59511 lon: -82.18874 facility: Baylr Sctt White Rs Inst, Endo status: WITHDRAWN city: Dallas state: Texas zip: 75226 country: United States lat: 32.78306 lon: -96.80667 facility: Velocity Clinical Res-Dallas status: RECRUITING city: Dallas state: Texas zip: 75230 country: United States lat: 32.78306 lon: -96.80667 facility: North Texas Endocrine Center status: RECRUITING city: Dallas state: Texas zip: 75231 country: United States lat: 32.78306 lon: -96.80667 facility: UT Southwestern Medical Center - Lingvay status: RECRUITING city: Dallas state: Texas zip: 75390 country: United States lat: 32.78306 lon: -96.80667 facility: DCOL Ctr for Clin Res status: RECRUITING city: Longview state: Texas zip: 75605 country: United States lat: 32.5007 lon: -94.74049 facility: Washington Cntr Weight Mgmt status: RECRUITING city: Arlington state: Virginia zip: 22206 country: United States lat: 38.88101 lon: -77.10428 facility: Health Res of Hampton Roads status: RECRUITING city: Newport News state: Virginia zip: 23606 country: United States lat: 37.08339 lon: -76.46965 facility: TPMG Clinical Research status: RECRUITING city: Newport News state: Virginia zip: 23606 country: United States lat: 37.08339 lon: -76.46965 facility: National Clin Res Inc. status: RECRUITING city: Richmond state: Virginia zip: 23294 country: United States lat: 37.55376 lon: -77.46026 facility: Paratus Clinical status: NOT_YET_RECRUITING city: Blacktown state: New South Wales zip: 2148 country: Australia lat: -33.76667 lon: 150.91667 facility: Northern Beaches Clinical Research status: RECRUITING city: Brookvale state: New South Wales zip: 2100 country: Australia lat: -33.76108 lon: 151.27446 facility: Holdsworth House Clinical Research status: RECRUITING city: Darlinghurst state: New South Wales zip: 2010 country: Australia lat: -33.87939 lon: 151.21925 facility: Novatrials status: RECRUITING city: Kotara state: New South Wales zip: 2289 country: Australia lat: -32.95 lon: 151.68333 facility: Paratus Clinical status: NOT_YET_RECRUITING city: Herston state: Queensland zip: 4006 country: Australia lat: -27.44453 lon: 153.01852 facility: University of Sunshine Coast status: RECRUITING city: Sippy Downs state: Queensland zip: 4556 country: Australia lat: -26.71793 lon: 153.05475 facility: CMAX Clinical Research status: NOT_YET_RECRUITING city: Norwood state: South Australia zip: 5067 country: Australia lat: -34.66667 lon: 149.73333 facility: Emeritus Research Melbourne status: NOT_YET_RECRUITING city: Camberwell state: Victoria zip: 3124 country: Australia lat: -37.84205 lon: 145.0694 facility: Austin Health, Metabolic Disorders Centre status: RECRUITING city: Heidelberg Heights state: Victoria zip: 3081 country: Australia lat: -37.74313 lon: 145.05695 facility: Linear Clinical Research status: WITHDRAWN city: Nedlands state: Western Australia zip: 6009 country: Australia lat: -31.98184 lon: 115.8073 facility: OCROM Clinic status: RECRUITING city: Suita-shi state: Osaka zip: 565-0853 country: Japan lat: 34.76143 lon: 135.51567 facility: ToCROM Clinic status: RECRUITING city: Tokyo zip: 160-0008 country: Japan lat: 35.6895 lon: 139.69171 hasResults: False
<\|newrecord\|> nctId: NCT06326047 id: NN9541-4945 id: U1111-1291-9196 type: OTHER domain: World Health Organization (WHO) id: jRCT2031230704 type: REGISTRY domain: JRCT briefTitle: A Research Study Comparing How Well Different Doses of the Medicine NN0519-0130 Lower Blood Sugar in People With Type 2 Diabetes overallStatus: RECRUITING date: 2024-03-18 date: 2024-11-25 date: 2025-08-26 date: 2024-03-22 date: 2024-04-18 name: Novo Nordisk A/S class: INDUSTRY briefSummary: This study will look at how well a new medicine called NNC0519-0130 helps people with type 2 diabetes lower their blood sugar and body weight. The study will test up to 7 different doses of NNC0519-0130. Which treatment participant will get is decided by chance. Participants will take 1-3 injections once a week. The study medicine will be injected under skin with a thin needle in the stomach, thigh, or upper arm. The study will last for about 40 weeks. conditions: Diabetes Mellitus, Type 2 studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: Sponsor staff involved in the clinical trial is masked according to company standard procedures. The study will be double-blinded within dose level of once weekly subcutaneously administered NNC0519-0130 and the corresponding volume-matched placebo arms. The active comparator arm with tirzepatide will be open label. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 288 type: ESTIMATED name: NNC0519-0130 name: Placebo name: Trizepatide measure: Change in Glycated haemoglobin (HbA1c) measure: Change in Glycated haemoglobin (HbA1c) measure: Relative change in body weight measure: Change in body weight measure: Change in fasting plasma glucose (FPG) measure: Continuous glucose monitoring (CGM): Change in time in range (TIR) 3.9-10.0 millimoles per liter (mmol/L) (70-180 milligrams per deciliter (mg/dL)) measure: Change in waist circumference measure: Change in systolic blood pressure (SBP) measure: Change in high sensitivity C-Reactive Protein (hsCRP) measure: Change in total cholesterol measure: Change in high-density lipoprotein (HDL) cholesterol measure: Change in low-density lipoprotein (LDL) cholesterol measure: Change in triglycerides measure: Number of adverse events sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Velocity Clin Res-Chula Vista status: RECRUITING city: Chula Vista state: California zip: 91911 country: United States lat: 32.64005 lon: -117.0842 facility: Valley Research status: NOT_YET_RECRUITING city: Fresno state: California zip: 93720 country: United States lat: 36.74773 lon: -119.77237 facility: Valley Research status: WITHDRAWN city: Fresno state: California zip: 93720 country: United States lat: 36.74773 lon: -119.77237 facility: Velocity Clin Res San Diego status: RECRUITING city: La Mesa state: California zip: 91942 country: United States lat: 32.76783 lon: -117.02308 facility: First Valley Med Grp Lancaster status: RECRUITING city: Lancaster state: California zip: 93534 country: United States lat: 34.69804 lon: -118.13674 facility: Torrance Clin Res Inst, Inc. status: RECRUITING city: Lomita state: California zip: 90717 country: United States lat: 33.79224 lon: -118.31507 facility: Pacific Clinical Studies status: RECRUITING city: Los Alamitos state: California zip: 90720 country: United States lat: 33.80307 lon: -118.07256 facility: Catalina Research Institute, LLC status: RECRUITING city: Montclair state: California zip: 91763 country: United States lat: 34.07751 lon: -117.68978 facility: Med Partners, Inc. status: RECRUITING city: Toluca Lake state: California zip: 91602 country: United States lat: 34.15262 lon: -118.35731 facility: UCLA Health Southbay Endocrine status: NOT_YET_RECRUITING city: Torrance state: California zip: 90505 country: United States lat: 33.83585 lon: -118.34063 facility: University Clin Investigators status: RECRUITING city: Tustin state: California zip: 92780 country: United States lat: 33.74585 lon: -117.82617 facility: University of Colorado Hospital status: RECRUITING city: Aurora state: Colorado zip: 80045 country: United States lat: 39.72943 lon: -104.83192 facility: Innovative Research of W Florida Inc. status: RECRUITING city: Clearwater state: Florida zip: 33756 country: United States lat: 27.96585 lon: -82.8001 facility: International Research Associates, LLC_Miami status: RECRUITING city: Miami state: Florida zip: 33183 country: United States lat: 25.77427 lon: -80.19366 facility: Centricity Research status: RECRUITING city: Columbus state: Georgia zip: 31904 country: United States lat: 32.46098 lon: -84.98771 facility: Elite Clinical Trials status: RECRUITING city: Blackfoot state: Idaho zip: 83221 country: United States lat: 43.19047 lon: -112.34498 facility: Methodist Medical_Center of Illinois status: RECRUITING city: Peoria state: Illinois zip: 61636 country: United States lat: 40.69365 lon: -89.58899 facility: MD Medical Research status: RECRUITING city: Oxon Hill state: Maryland zip: 20745 country: United States lat: 38.80345 lon: -76.9897 facility: Endo And Metab Cons status: WITHDRAWN city: Rockville state: Maryland zip: 20852 country: United States lat: 39.084 lon: -77.15276 facility: Clinvest Research status: RECRUITING city: Springfield state: Missouri zip: 65807 country: United States lat: 37.21533 lon: -93.29824 facility: Mercury Str Med Grp, PLLC status: RECRUITING city: Butte state: Montana zip: 59701 country: United States lat: 46.00382 lon: -112.53474 facility: Palm Research Center Inc-Vegas status: RECRUITING city: Las Vegas state: Nevada zip: 89128 country: United States lat: 36.17497 lon: -115.13722 facility: Velocity Clinical Research Binghamton status: RECRUITING city: Binghamton state: New York zip: 13905 country: United States lat: 42.09869 lon: -75.91797 facility: PharmQuest Life Sciences LLC status: RECRUITING city: Greensboro state: North Carolina zip: 27408 country: United States lat: 36.07264 lon: -79.79198 facility: Accellacare Wilmington status: NOT_YET_RECRUITING city: Wilmington state: North Carolina zip: 28401 country: United States lat: 34.22573 lon: -77.94471 facility: Accellacare Wilmington status: RECRUITING city: Wilmington state: North Carolina zip: 28401 country: United States lat: 34.22573 lon: -77.94471 facility: Diab & Endo Assoc of Stark Co status: RECRUITING city: Canton state: Ohio zip: 44718 country: United States lat: 40.79895 lon: -81.37845 facility: Velocity Clin Res_Cincinnati status: RECRUITING city: Cincinnati state: Ohio zip: 45242 country: United States lat: 39.12713 lon: -84.51435 facility: Velocity Clinical Research Springdale status: RECRUITING city: Cincinnati state: Ohio zip: 45246 country: United States lat: 39.12713 lon: -84.51435 facility: Providence Health Partners Ctr status: RECRUITING city: Dayton state: Ohio zip: 45439 country: United States lat: 39.75895 lon: -84.19161 facility: Advanced Med Res Maumee status: RECRUITING city: Maumee state: Ohio zip: 43537 country: United States lat: 41.56283 lon: -83.65382 facility: Tristar Clin Investigations, PC status: RECRUITING city: Philadelphia state: Pennsylvania zip: 19114 country: United States lat: 39.95233 lon: -75.16379 facility: Preferred Primary Care Physicians Inc. status: RECRUITING city: Pittsburgh state: Pennsylvania zip: 15243 country: United States lat: 40.44062 lon: -79.99589 facility: Preferred Primary Care Physicians, Inc. status: RECRUITING city: Uniontown state: Pennsylvania zip: 15401 country: United States lat: 39.90008 lon: -79.71643 facility: Velocity Clinical Research Abilene status: RECRUITING city: Abilene state: Texas zip: 79606 country: United States lat: 32.44874 lon: -99.73314 facility: Velocity Clin Res Austin status: RECRUITING city: Austin state: Texas zip: 78759 country: United States lat: 30.26715 lon: -97.74306 facility: Velocity Clinical Res-Dallas status: RECRUITING city: Dallas state: Texas zip: 75230 country: United States lat: 32.78306 lon: -96.80667 facility: Endocrine Associates Houston status: RECRUITING city: Houston state: Texas zip: 77004 country: United States lat: 29.76328 lon: -95.36327 facility: Biopharma Informatic_Houston status: RECRUITING city: Houston state: Texas zip: 77043 country: United States lat: 29.76328 lon: -95.36327 facility: Biopharma Informatic_Houston status: NOT_YET_RECRUITING city: Houston state: Texas zip: 77043 country: United States lat: 29.76328 lon: -95.36327 facility: Consano Clinical Research, LLC status: RECRUITING city: Shavano Park state: Texas zip: 78231 country: United States lat: 29.58495 lon: -98.55252 facility: Burke Internal Medicine & Research status: RECRUITING city: Burke state: Virginia zip: 22015 country: United States lat: 38.79345 lon: -77.27165 facility: TPMG Clinical Research status: RECRUITING city: Newport News state: Virginia zip: 23606 country: United States lat: 37.08339 lon: -76.46965 facility: Macquarie University status: NOT_YET_RECRUITING city: Macquarie Park state: New South Wales zip: 2109 country: Australia lat: -33.7751 lon: 151.11272 facility: Royal North Shore Hospital status: NOT_YET_RECRUITING city: St Leonards state: New South Wales zip: 2065 country: Australia lat: -33.82344 lon: 151.19836 facility: Western Endocrine Blacktown status: NOT_YET_RECRUITING city: Sydney state: New South Wales zip: 2148 country: Australia lat: -33.86785 lon: 151.20732 facility: Western Endocrine Blacktown status: WITHDRAWN city: Sydney state: New South Wales zip: 2148 country: Australia lat: -33.86785 lon: 151.20732 facility: Illawarra Diabetes Service Clinical Trials & Research Unit status: NOT_YET_RECRUITING city: Wollongong state: New South Wales zip: 2500 country: Australia lat: -34.424 lon: 150.89345 facility: University of Sunshine Coast status: NOT_YET_RECRUITING city: Birtinya state: Queensland zip: 4575 country: Australia lat: -26.74322 lon: 153.11913 facility: Eastern Clinical Research Unit Box Hill status: NOT_YET_RECRUITING city: Box Hill state: Victoria zip: 3128 country: Australia lat: -37.81887 lon: 145.12545 facility: Austin Health, Metabolic Disorders Centre status: NOT_YET_RECRUITING city: Heidelberg Heights state: Victoria zip: 3081 country: Australia lat: -37.74313 lon: 145.05695 facility: The Royal Melbourne Hospital status: NOT_YET_RECRUITING city: Parkville state: Victoria zip: 3050 country: Australia lat: -37.78333 lon: 144.95 facility: OCT Research ULC (dba Okanagan Clinical Trials) status: RECRUITING city: Kelowna state: British Columbia zip: V1Y 1Z9 country: Canada lat: 49.88307 lon: -119.48568 facility: OCT Research ULC (dba Okanagan Clinical Trials) status: NOT_YET_RECRUITING city: Kelowna state: British Columbia zip: V1Y 1Z9 country: Canada lat: 49.88307 lon: -119.48568 facility: Cook Street Medical Clinic status: RECRUITING city: Victoria state: British Columbia zip: V8V 4A1 country: Canada lat: 48.43294 lon: -123.3693 facility: G.A. Research Associates Ltd. status: RECRUITING city: Moncton state: New Brunswick zip: E1G 1A7 country: Canada lat: 46.09454 lon: -64.7965 facility: Nova Scotia Hlth Halifax status: NOT_YET_RECRUITING city: Halifax state: Nova Scotia zip: B3H 1V7 country: Canada lat: 44.64533 lon: -63.57239 facility: Wharton Med Clin Trials status: RECRUITING city: Hamilton state: Ontario zip: L8L 5G8 country: Canada lat: 43.25011 lon: -79.84963 facility: Albion Finch Medical Centre status: NOT_YET_RECRUITING city: Toronto state: Ontario zip: M9V 4B4 country: Canada lat: 43.70011 lon: -79.4163 facility: Albion Finch Medical Centre status: RECRUITING city: Toronto state: Ontario zip: M9V 4B4 country: Canada lat: 43.70011 lon: -79.4163 facility: Centricity Research Quebec City status: RECRUITING city: Levis state: Quebec zip: G6W 0M5 country: Canada lat: 46.80326 lon: -71.17793 facility: Recherche GCP Research status: NOT_YET_RECRUITING city: Montreal state: Quebec zip: H1Y 3H5 country: Canada lat: 45.50884 lon: -73.58781 facility: Centricity Research Ville St. Laurent VSL status: WITHDRAWN city: Ville Saint-Laurent state: Quebec zip: H4T 1Z9 country: Canada facility: Diex Recherche Quebec Inc. status: NOT_YET_RECRUITING city: Quebec zip: G1V 4T3 country: Canada lat: 46.81228 lon: -71.21454 facility: Life Care Clinic & Research Centre status: NOT_YET_RECRUITING city: Bangalore state: Karnataka zip: 560092 country: India lat: 12.97194 lon: 77.59369 facility: Amrita Institute Of Medical Sciences & Research Centre status: NOT_YET_RECRUITING city: Kochi state: Kerala zip: 682041 country: India lat: 9.93988 lon: 76.26022 facility: Seth GS Medical College & KEM Hospital status: NOT_YET_RECRUITING city: Mumbai state: Maharashtra zip: 400012 country: India lat: 19.07283 lon: 72.88261 facility: Chellaram Diabetes Institute status: NOT_YET_RECRUITING city: Pune state: Maharashtra zip: 411021 country: India lat: 18.51957 lon: 73.85535 facility: Christian Medical College Hospital, Vellore status: NOT_YET_RECRUITING city: Vellore state: Tamil Nadu zip: 632004 country: India lat: 12.9184 lon: 79.13255 facility: Kumudini Devi Diabetes Research Center, Ramdevrao Hospital status: NOT_YET_RECRUITING city: Hyderabad state: Telangana zip: 500072 country: India lat: 17.38405 lon: 78.45636 facility: MS Ramaiah status: NOT_YET_RECRUITING city: Bengaluru zip: 560054 country: India lat: 12.97194 lon: 77.59369 facility: Tokuyama clinic status: RECRUITING city: Chiba zip: 261-0004 country: Japan lat: 35.6 lon: 140.11667 facility: Soka Sugiura Internal Medicine Clinic status: RECRUITING city: Soka-shi, Saitama zip: 340-0015 country: Japan facility: Soka Sugiura Internal Medicine Clinic status: NOT_YET_RECRUITING city: Soka-shi, Saitama zip: 340-0015 country: Japan facility: Tokyo-Eki Center-building Clinic status: RECRUITING city: Tokyo zip: 103-0027 country: Japan lat: 35.6895 lon: 139.69171 facility: Fukuwa Clinic status: RECRUITING city: Tokyo zip: 104-0031 country: Japan lat: 35.6895 lon: 139.69171 facility: Fukuwa Clinic status: NOT_YET_RECRUITING city: Tokyo zip: 104-0031 country: Japan lat: 35.6895 lon: 139.69171 facility: Seoul National University Bundang Hospital status: NOT_YET_RECRUITING city: Gyeonggi-do zip: 13620 country: Korea, Republic of lat: 37.58944 lon: 126.76917 facility: Nowon Eulji Medical Center, Eulji University status: NOT_YET_RECRUITING city: Seoul zip: 01830 country: Korea, Republic of lat: 37.566 lon: 126.9784 facility: Korea University Anam Hospital status: NOT_YET_RECRUITING city: Seoul zip: 02841 country: Korea, Republic of lat: 37.566 lon: 126.9784 facility: Kangbuk Samsung Hospital status: NOT_YET_RECRUITING city: Seoul zip: 03181 country: Korea, Republic of lat: 37.566 lon: 126.9784 facility: Asan Medical Center status: NOT_YET_RECRUITING city: Seoul zip: 05505 country: Korea, Republic of lat: 37.566 lon: 126.9784 facility: Josha Research status: WITHDRAWN city: Bloemfontein state: Free State zip: 9301 country: South Africa lat: -29.12107 lon: 26.214 facility: Wits Bara Clinical Trial Site status: WITHDRAWN city: Johannesburg state: Gauteng zip: 2013 country: South Africa lat: -26.20227 lon: 28.04363 facility: Shop#1 Health Emporium status: WITHDRAWN city: Midrand state: Gauteng zip: 1685 country: South Africa lat: -25.98953 lon: 28.12843 facility: Dr Pillay's Rooms status: WITHDRAWN city: Durban state: KwaZulu-Natal zip: 4450 country: South Africa lat: -29.8579 lon: 31.0292 facility: Dr T Padayachee status: WITHDRAWN city: Umkomaas state: KwaZulu-Natal zip: 4170 country: South Africa lat: -30.20674 lon: 30.79776 hasResults: False
<\|newrecord\|> nctId: NCT06326034 id: AAA234 briefTitle: Impact of Dapagliflozin as Add-on Therapy on Glycemic Status and Quality of Life in Type 2 Diabetic Patients overallStatus: COMPLETED date: 2022-05-01 date: 2023-01-01 date: 2023-01-01 date: 2024-03-22 date: 2024-03-22 name: Mohammed Mahmood Mohammed class: OTHER briefSummary: Type 2 Diabetes Mellitus (T2DM) is a syndrome of metabolic dysregulation that needs a multifactorial behavioral and pharmacological treatments to prevent or delay complications, morbidity and mortality. Uncontrolled hyperglycemia can be negatively affecting the patient's physical and psychological status and thus lower the patient's quality of life (QoL) (Verma \& Dadarwal, 2017)(Vanstone et al., 2015)(Gebremedhin et al., 2019). According to American Diabetes Association (ADA), when hyperglycaemia remain uncontrolled (HbA1c ≥1.5% above the glycemic target), a second therapy for T2DM is needed (Davies et al., 2022).
It has been certained by ADA, beside the glucose lowering effect the add-on antidibetic medication should have an impact on weight management to achieve and maintain the optimum glycemic and weight control which are the goals in people without established cardiorenal risks (Vijan et al., 2014((Inzucchi et al., 2012). Although metformin still the first-line pharmacotherapy in most T2DM patients, according to American Diabetes Association (ADA) (Association, 2020) but has little or even weight neutral effect, as well as gliptins (Hermansen \& Mortensen, 2007)(Sazan et al., 2012). Other old antidibetic classes such as thiazolidinediones (TZDs) and sulfonylureas (SUs) inspite of their efficacy in controlling glycemia but their use is associated with weight gain and other adverse effects (Derosa \& Maffioli, 2010)(Najim et al., 2014)(Fonseca, 2003). However, The newest class of antidibetic drugs, sodium-glucose cotransporter 2 inhibitors (SGLT2i), are approved for the treatment of T2DM as add-on or even initial therapy (Tamez-Pérez et al., 2013). This class is act by inducing glycosuria and thus improving glycemic status without affecting insulin level (Merovci et al., 2015). Dapagliflozin is a highly selective inhibitor of SGLT2. It has been well tolerated and its safety and efficacy approved in the clinical trials, mostly on cardio-renal outcomes with additional benefits of weight loss and low risk of hypoglycemia (Heerspink et al., 2020)(Solomon et al., 2022)(Wiviott et al., 2019)(McMurray et al., 2019). To date, no clinical data regarding SGLT2i recorded in Iraqi patients with limited data available on Arabic population. On Qatari, assessment of Dapagliflozin effectiveness revealed a significant improvement in the glycemic status after 6 months when used in combination with standard therapy, a reduction (Al AdAwi et al., 2019). In Saudi Arabia, Dapagliflozin was found to be well-tolerated and effective treatment option for T2DM patients after 6 months (Alguwaihes, 2021). conditions: Diabetic Nephropathy Type 2 studyType: INTERVENTIONAL phases: PHASE4 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: This interventional randomized clinical study was conducted from May to December 2022, at the National Diabetic Centre for treatment and research/ Mustansiriyah University/ Baghdad/ Iraq. Ethical approval from the diabetic center and college of pharmacy/ Mustansiriyah University, was taken prior to the study initiation. All investigations/ procedures carried out in this study involving human participants were in accordance with the 1975 Declaration of Helsinki and its later amendments. primaryPurpose: TREATMENT masking: NONE count: 40 type: ACTUAL name: Dapagliflozin measure: Quality of Life Assessment tool sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mohammed Mahmood Mahmood city: Baghdad zip: 00964 country: Iraq lat: 33.34058 lon: 44.40088 hasResults: False
<\|newrecord\|> nctId: NCT06326021 id: BJGBYY-IIT-LCYJ-2024-004 briefTitle: Optimised CD33 (FL-33) CAR T Therapy for Refractory/Relapsed Acute Myeloid Leukaemia overallStatus: RECRUITING date: 2024-04-11 date: 2026-06-15 date: 2026-12-30 date: 2024-03-22 date: 2024-04-16 name: Beijing GoBroad Hospital class: OTHER briefSummary: This study is a single-center, open-label, non-randomised, single-arm phaseⅠclinical trial to explore the safety and efficacy of FL-33 CAR T therapy for refractory/relapsed acute myeloid leukaemia. The primary endpoints are incidence and type of dose limiting toxicity within 21 days of CAR T infusion; total number, incidence and severity of adverse events (AE) 30 days after CAR T infusion. The secondary endpoints are total number, incidence and severity of AEs 30 days to 2 years after CAR T infusion; objective response rate (ORR), complete response rate (CR) and complete response with incomplete haematological recovery (CRi) by dose group at 15, 30 and 90 Days after CAR T Infusion; duration of response (DOR), progression-free survival (PFS), overall survival (OS); pharmacokinetic characteristics. The trial will use BOIN12 design to explore the optimal biological dose (OBD) of FL-33 CAR T cells for refractory/relapsed acute myeloid leukaemia. FL-33 CAR T is set at two dose levels: 5\10\^5 (±20%) CAR-T cells/kg for dose 1 (DL-1) and 1\10\^6 (±20%) CAR-T cells/kg for dose 2 (DL-2), and after the optimal biological dose (OBD) is determined in the dose exploration phase, the dose expansion phase will expand the trial by 6-12 cases at the OBD, enrolling up to 21-27 cases. Enrolment of more than 21 cases can be reported for analysis and the trial will be stopped when enrolment reaches 27 cases. conditions: Refractory/Relapsed Acute Myeloid Leukaemia studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 27 type: ESTIMATED name: autologous FL-33 CAR T therapy name: prior-HSCT donor-derived FL-33 CAR T therapy measure: Dose-limiting toxicity(DLT) measure: Adverse events (AEs) measure: Long-term Adverse events (AEs) measure: Objective Response Rate (ORR) measure: Duration of response (DOR) measure: Progression-free survival (PFS) measure: Overall survival (OS) measure: The persistence of FL-33 CAR T cells sex: ALL minimumAge: 1 Year maximumAge: 70 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: BeijingGoBroadH status: RECRUITING city: Beijing country: China name: Tengyu Wang role: CONTACT phone: 18333186020 email: tengyu.wang@gohealtharo.com lat: 39.9075 lon: 116.39723 hasResults: False
<\|newrecord\|> nctId: NCT06326008 id: BJGBYY-IIT-LCYJ-2023-002 briefTitle: Safety, Tolerability, and Pharmacokinetics of Donor-derived CD19 CAR Therapy Bridged Allo-HSCT and Sequential Donor-derived CD22 CAR Therapy for r/r B-ALL: a Clinical Trial overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2026-03-15 date: 2026-06-30 date: 2024-03-22 date: 2024-03-27 name: Beijing GoBroad Hospital class: OTHER briefSummary: This is an investigator-initiated, single-arm, open-label, non-randomised phase I clinical study. The objective of this trial is to evaluate the safety, tolerability and pharmacokinetics of donor-derived CD19 CAR Therapy bridged Allo-HSCT and sequential donor-derived CD22 CAR Therapy for r/r B-ALL and to explore the efficacy of this therapy preliminarily. The primary endpoints are incidence and type of dose-limiting toxicity (DLT) within 28 days (i.e., 43 days after donor-derived CD19 CAR T-cell infusion) after donor-derived CD19 CAR T-cell therapy bridged allogeneic haematopoietic stem cell transplantation; total number, incidence and severity of adverse events from donor-derived CD19 CAR T cell infusion back to 30 days after donor-derived CD22 CAR T cell infusion (i.e., within 120 days of donor-derived CD19 CAR T cell infusion). The secondary endpoints are total number, incidence and severity of adverse events from 120 days to 2 years after donor-derived CD19 CAR T-cell infusion; ORR(CR+CRi) on days 45, 90, 120; duration of response(DOR), event-free survival(EFS), overall survival(OS); pharmacokinetics characteristics. The trial plan to enroll 3\~12 cases in dose escalation phase and 36 cases in dose expansion phase. conditions: B-cell Acute Lymphoblastic Leukemia conditions: Acute Lymphoblastic Leukemia, in Relapse studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 48 type: ESTIMATED name: Donor-derived CD19 CAR Therapy Bridged Allo-HSCT and Sequential Donor-derived CD22 CAR Therapy measure: Dose-limiting toxicity (DLT) measure: Adverse events (AEs) measure: Long-term Adverse events (AEs) measure: Objective response rate(ORR) measure: Duration of response (DOR) measure: Event-free survival (EFS) measure: Overall survival (OS) measure: The persistence of CD19/CD22 CAR T cells. measure: The Maximum concentration (Cmax) of CD19/CD22 CAR T cells. measure: The time to maximum plasma concentration (Tmax) of CD19/CD22 CAR T cells. sex: ALL minimumAge: 1 Year maximumAge: 18 Years stdAges: CHILD stdAges: ADULT hasResults: False
<\|newrecord\|> nctId: NCT06325995 id: Changhai HHHospital briefTitle: Hypofractionated Post-prostatectomy Radiotherapy (HYPORT)for Localized Prostate Cancer overallStatus: RECRUITING date: 2023-10-01 date: 2025-10-01 date: 2030-10-01 date: 2024-03-22 date: 2024-03-22 name: Changhai Hospital class: OTHER briefSummary: The aim of this trial is to compare the safety outcomes of Hypofractionated postprostatectomy radiotherapy (HYPORT) and Conventionally fractionated postprostatectomy radiotherapy(COPORT) in treating patients with localized prostate cancer.
Accumulating evidence has proven the safety and feasibility of HYPORT for localized prostate cancer.But for localized prostate cancer,the optimal dose per fraction of HYPORT is still on its way.
It is not yet known whether giving HYPORT(57.5-65 Gy in 23-26 daily fractions of 2.5 Gy ) with or COPORT may work better in treating patients with prostate cancer. conditions: Localized Prostate Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 428 type: ESTIMATED name: Conventional radiation therapy name: Hypofractionated radiation therapy measure: Incidence of radiotherapy-related gastrointestinal and urogenital tract adverse events measure: 5-year progression-free survival (PFS) measure: quality of life (QoL) measure: medical expenses measure: Overall survival (OS) measure: Prostate cancer-specific survival sex: MALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Changhai hospital status: RECRUITING city: Shanghai state: Shanghai zip: 200433 country: China name: Huojun Zhang, M.D. role: CONTACT phone: +8613311732399 email: chyyzhj@163.com name: Huojun Zhang, M.D. role: PRINCIPAL_INVESTIGATOR lat: 31.22222 lon: 121.45806 hasResults: False
<\|newrecord\|> nctId: NCT06325982 id: BYFFL-01 briefTitle: Clinical Observation of Drug Retention Enema in Preventing Acute Radiation-induced Rectal Injury overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-05-01 date: 2025-12-31 date: 2024-03-22 date: 2024-03-22 name: Fujian Cancer Hospital class: OTHER_GOV briefSummary: The main objective of this study was to evaluate the efficacy and safety of drug retention enema for the prevention of acute radiation rectal injury in the real world. conditions: Radiation Injuries conditions: Rectal Diseases studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: PREVENTION masking: NONE count: 200 type: ESTIMATED name: Triethanolamine cream measure: Occurrence time of acute and chronic radiation rectal injury measure: Evaluation of acute and chronic radiation rectal injury measure: Clinical symptom assessment measure: Quality of life assessment assessed by IBDQ sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06325969 id: PCOS Immune briefTitle: PCOS Patients Immune Status Evaluation overallStatus: RECRUITING date: 2024-03-16 date: 2025-12-01 date: 2026-03-08 date: 2024-03-22 date: 2024-03-22 name: Shanghai 10th People's Hospital class: OTHER briefSummary: In this study, the investigators will include PCOS patients and healthy women who meet the trial criteria from the clinical research centers of 3 hospitals, introduce the content of this study to participants, and invite participants to participate. Flow cytometry was used to detect the immune function of peripheral blood samples of PCOS patients, to clarify the immune function characteristics of PCOS patients, and to try to establish an evaluation method of the immune function of PCOS patients. conditions: Polycystic Ovary Syndrom conditions: Metformin conditions: Immune Function studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 250 type: ESTIMATED name: Detect the immune function of peripheral blood samples measure: The number of cell groups expressing different markers were counted by the fluorescence detection system on flow cytometry. measure: The percentage of cell groups expressing different markers were counted by the fluorescence detection system on flow cytometry. measure: Homeostasis model assessment of insulin resistance measure: body mass index measure: menstrual frequency measure: fasting glucose measure: fasting insulin measure: Total cholesterol measure: Triglycerides measure: HDL-c measure: LDL-c measure: total testosterone measure: free testosterone measure: Sex hormone-binding globulin measure: Androstenedione measure: Dehydroepiandrosterone sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Department of Endocrinology, Shanghai Tenth People's Hospital status: RECRUITING city: Shanghai zip: 200072 country: China name: Manna Zhang, Doctor role: CONTACT phone: +86-021-66301004 email: mannazhang@126.com lat: 31.22222 lon: 121.45806 hasResults: False
<\|newrecord\|> nctId: NCT06325956 id: Immune status and metformin briefTitle: PCOS Immune Function Predicts Metformin Efficacy overallStatus: RECRUITING date: 2024-03-16 date: 2025-12-01 date: 2026-07-01 date: 2024-03-22 date: 2024-03-22 name: Shanghai 10th People's Hospital class: OTHER briefSummary: In this study, the investigators will include PCOS patients who meet the trial criteria, introduce participants to the content of this study, and invite participants to participate. The immune function of peripheral blood samples of PCOS patients was detected by flow cytometry. Participants were further treated with metformin for 6 months and followed up after the intervention. The objective of this study was to investigate immune markers related to the efficacy of metformin in PCOS patients and to predict the efficacy of metformin in PCOS patients using immune function. conditions: Polycystic Ovary Syndrome conditions: Metformin conditions: Immune Function studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 100 type: ESTIMATED name: Metformin measure: The number of cell groups expressing different markers were counted by the fluorescence detection system on flow cytometry. measure: The percentage of cell groups expressing different markers were counted by the fluorescence detection system on flow cytometry. measure: Homeostasis model assessment of insulin resistance measure: body mass index measure: menstrual frequency measure: fasting glucose measure: fasting insulin measure: Total cholesterol measure: Triglycerides measure: HDL-c measure: LDL-c measure: total testosterone measure: free testosterone measure: Sex hormone-binding globulin measure: Androstenedione measure: Dehydroepiandrosterone sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Department of Endocrinology, Shanghai Tenth People's Hospital status: RECRUITING city: Shanghai zip: 200072 country: China name: Manna Zhang, Doctor role: CONTACT phone: 86-21-66301004 email: mannazhang@126.com lat: 31.22222 lon: 121.45806 hasResults: False
<\|newrecord\|> nctId: NCT06325943 id: CIDPRIT briefTitle: Rituximab in Chronic Inflammatory Demyelinating Polyradiculoneuropathy acronym: CIDPRIT overallStatus: COMPLETED date: 2019-04-01 date: 2023-05-30 date: 2023-11-30 date: 2024-03-22 date: 2024-03-26 name: Istituto Clinico Humanitas class: OTHER name: Ospedale Mondino di Pavia name: University of Turin, Italy name: Istituto Neurologico Carlo Besta di Milano name: San Raffaele University Hospital, Italy name: Università di Messina name: Universita degli Studi di Genova name: Istituto Di Ricerche Farmacologiche Mario Negri name: Università di Napoli Federico II briefSummary: Randomized double-blind controlled study of rituximab versus placebo in patients with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) on chronic treatment with immunoglobulins. The primary objective of the study is to determine whether rituximab treatment is effective in preventing the disease from getting worse after stopping immunoglobulin treatment for six months in patients with CIDP. The secondary objective is to evaluate whether treatment with rituximab can improve the response to therapy compared to placebo in patients treated with immunoglobulins and whether it can allow to delay the mean time of worsening after discontinuation of immunoglobulin therapy.
Exploratory objectives are the correlation between response to rituximab therapy and the clinical form of CIDP and the presence of antibody reactivity against node of Ranvier antigens. Intervention will be Rituximab or placebo, 1 g by intravenous infusion on day 1 and 15 after randomization and concomitant treatment for 6 months with intravenous or subcutaneous immunoglobulin at the same dosage as before randomization. conditions: Polyradiculoneuropathy, Chronic Inflammatory Demyelinating studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This study is a phase 3, multicenter, randomized, placebo-controlled, parallel-group, double-blind study primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 37 type: ACTUAL name: Rituximab name: Placebo measure: Inflammatory Neuropathy Cause and Treatment (INCAT) scale, range 0-10 points with higher values meaning more severe disability measure: Medical Research Council (MRC), range 0-60 with lower values meaning more severe disability measure: Inflammatory Rasch-built Overall Disability Scale (I-RODS), range 0-48 with lower values meaning more severe disability measure: Inflammatory Neuropathy Cause and Treatment (INCAT) scale, , range 0-10 points with higher values meaning more severe disability measure: Inflammatory Neuropathy Cause and Treatment (INCAT) scale, range 0-10 points with higher values meaning more severe disability measure: treatment suspension measure: time to worsening measure: Short Form Health Survey 36 (SF-36), range from 0 to 100, with a higher score defining a more favorable health state measure: motor conduction block in the two most relevant nerves, range 0-100% with lower score defining lesser degree of impairment measure: clinical form measure: response to rituximab in patients with antinerve antibodies sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Istituto Clinico Humanitas city: Rozzano country: Italy lat: 45.38193 lon: 9.1559 hasResults: False
<\|newrecord\|> nctId: NCT06325930 id: RIV-HU6-105 briefTitle: A Study to Investigate the Absorption, Metabolism, and Excretion of [14C]-HU6 overallStatus: RECRUITING date: 2024-03-26 date: 2024-05-22 date: 2024-05-22 date: 2024-03-22 date: 2024-04-17 name: Rivus Pharmaceuticals, Inc. class: INDUSTRY briefSummary: This is a single-center, non-randomized, open-label Phase 1 study to characterize the absorption, metabolism, excretion, mass balance, pharmacokinetics (PK), safety and tolerability of HU6 following administration of a single dose of \[14C\]-HU6 in a fed state with a standard meal administered approximately 15 minutes prior to dosing. conditions: Healthy studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 8 type: ESTIMATED name: [14C]-HU6 measure: To assess the mass balance sex: MALE minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Pharmaron Clinical Pharmacology Center (CPC) status: RECRUITING city: Baltimore state: Maryland zip: 21201 country: United States name: Kristin Satterfield, MD, PhD role: CONTACT lat: 39.29038 lon: -76.61219 hasResults: False
<\|newrecord\|> nctId: NCT06325917 id: 101271-5 briefTitle: Effect of Diabetes Self-management Education and Support on Glycemic Control Among Patients With Type 2 Diabetic acronym: DSMES overallStatus: ACTIVE_NOT_RECRUITING date: 2022-11-01 date: 2024-07-01 date: 2024-07-30 date: 2024-03-22 date: 2024-03-22 name: University of Jordan class: OTHER briefSummary: Introduction: Diabetes mellitus (DM) is one of the chronic diseases that can have an impact on increasing morbidity, disability, and death. Social media has become a valuable resource for people with diabetes in improving self-management skills Applying diabetes self-management education with ongoing support using social media produces behavioral changes, empowerment, and cost-effectiveness.
purpose: the purpose of this study is to examine the effect of self-management education with ongoing support using social media (WhatsApp) on glycemic control among patients with uncontrolled diabetes.
Method: 140 patients with diabetes type 2 attending outpatients' diabetes clinic setting in Aqaba will participate in a two-arm randomized controlled trial study. Self-management education will be applied for all participants, ongoing support using social media (what's app) will be applied to the intervention group, and only usual diabetes care by a diabetes specialist nurse will be applied to the control group. conditions: Diabetes Mellitus, Type 2 studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: two arms parallel randomized controlled primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 140 type: ACTUAL name: what's app ongoing support name: usual care measure: glycemic control measure: diabetes self management behaviors sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Jordan city: Amman zip: 11942 country: Jordan lat: 31.95522 lon: 35.94503 hasResults: False
<\|newrecord\|> nctId: NCT06325904 id: 9138930 briefTitle: Uniportal VATS Versus Chest Tube for Early Empyema overallStatus: COMPLETED date: 2021-03-01 date: 2023-06-01 date: 2023-12-01 date: 2024-03-22 date: 2024-03-25 name: Minia University class: OTHER briefSummary: This randomized controlled study compared uniportal video-assisted thoracoscopic surgery (U-VATS) versus chest tube drainage for initial (first-line) treatment of stage I (exudative) and stage II (fibrinopurulent) empyema in adult patients (\>18 years old). The primary end-point of outcome was the overall success of treatment (no need for re-intervention or death). The main results demonstrated the safety of minimally invasive U-VATS procedure in the initial treatment of early stages of pleural empyema in comparison to traditional chest tube drainage. Initial use of U-VATS was safe and feasible due to postoperative freedom from complex or marked effusion, in addition to significant reduction in the need for additional intervention, postoperative complications, length of hospital stay, and total cost. conditions: Empyema, Pleural studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 70 type: ACTUAL name: Uniportal VATS name: Tube thoracostomy measure: Need for further management measure: Mortality sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Minia University city: Minya zip: 61111 country: Egypt lat: 28.10988 lon: 30.7503 hasResults: False
<\|newrecord\|> nctId: NCT06325891 id: RP025 briefTitle: Microbiota in Gastric Cancer by Gastric Mucosal Brushing overallStatus: RECRUITING date: 2024-02-01 date: 2025-03-31 date: 2025-05-31 date: 2024-03-22 date: 2024-03-22 name: King Chulalongkorn Memorial Hospital class: OTHER briefSummary: Many studies have shown a significant change of diversity and composition in gut microbiota across the gastric carcinogenesis process, particularly in patients with gastric cancer. However, there has been no analysis of gastric microbiota using the mucosal brushing technique, despites its favoring benefit in microbiota study. Therefore, our study aims to evaluate microbiota profile in patients with gastric cancer, compared to those without gastric cancer by using mucosal brush sampling. This will improve current knowledge of the potential role of the microbiome in patient gastric cancer as a future biomarker marker using brushing sampling. conditions: Gastric Cancer studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 40 type: ESTIMATED name: Gastric mucosal brusing name: Gastric mucosal biopsy measure: Microbiome analysis using gastric mucosal brushing measure: Microbiome analysis using gastric mucosal biopsy sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: King Chulalongkorn Memorial Hospital status: RECRUITING city: Bangkok zip: 10330 country: Thailand name: Rapat Pittayanon, MD role: CONTACT phone: +66813132112 email: rapat125@gmail.com name: Thanrada Vimonsuntirungsri role: CONTACT phone: +66853356240 email: aa_choc@docchula.com lat: 13.75398 lon: 100.50144 facility: King Chulalongkorn memorial hospital status: RECRUITING city: Bangkok zip: 10330 country: Thailand name: Thanrada Vimonsuntirungsri, MD role: CONTACT phone: +66853356240 email: aa_choc@docchula.com lat: 13.75398 lon: 100.50144 hasResults: False
<\|newrecord\|> nctId: NCT06325878 id: NEU2-OSS-2022-001 briefTitle: Genetic Architecture of Chronic Inflammatory Demyelinating Polyradiculoneuropathy acronym: GEARCIDP overallStatus: RECRUITING date: 2022-11-15 date: 2025-12-31 date: 2025-12-31 date: 2024-03-22 date: 2024-03-26 name: Istituto Clinico Humanitas class: OTHER briefSummary: The objective of this study is to characterize the genetic architecture of a large cohort of CIDP patients to evaluate whether specific alleles/haplotypes are implicated in the risk of CIDP, in its clinical and immunological variability, severity, therapeutic response, and association with diabetes and other autoimmune diseases. We will genotype \>700,000 single nucleotide polymorphisms (SNPs) by using the Illumina Global Screening Array (GSA), of approximately 1000 patients with CIDP. About 3500 healthy controls from the Italian population have been already genotyped using GWAS from our genetic department. Alleles/haplotypes will be also compared between patients with typical CIDP and its variants, between CIDP patients with and without specific antibodies, between CIDP patients with and without comorbidities, between CIDP patients with low and high levels of disability and between CIDP patients with and without response to each individual treatment (IVIg, steroids, plasma exchange) conditions: Chronic Inflammatory Demyelinating Polyradiculoneuropathy studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: NONE count: 3500 type: ESTIMATED name: Genome-wide association study measure: single nucleotide polymorphisms (SNPs) sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Istituto Clinico Humanitas status: RECRUITING city: Rozzano country: Italy name: Eduardo Nobile Orazio, Prof role: CONTACT email: eduardo.nobile@unimi.it lat: 45.38193 lon: 9.1559 hasResults: False
<\|newrecord\|> nctId: NCT06325865 id: 23C305 briefTitle: Perception of Unpleasant Sensations During Study Procedures in ALS Patients acronym: PESALS overallStatus: RECRUITING date: 2023-04-19 date: 2024-11 date: 2024-12 date: 2024-03-22 date: 2024-03-22 name: Istituto Auxologico Italiano class: OTHER briefSummary: Diagnosis of Amyotrophic Lateral Sclerosis (ALS) is considered a traumatic life event for both the patient and their next-of-kin/carers, due to the lack of treatment. Clinical Trials can offer pioneering treatment to reduce the impact of the disease and improve future treatments worldwide. Research protocols may involve routine diagnostic and/or therapeutic procedures which the patients may be already aware of and, therefore, expecting specific sensations. These could compromise participation or drop-out rate. Despite everything, participation in a clinical trial can guarantee continuity of care also thanks to the execution of these same procedures, through preferential access compared to other patients.
Aim of this study is to investigate the unpleasant sensations perceived by ALS patients during procedures in clinical trials. Analysing what type of pain/discomfort frightens patients during diagnostic and/or therapeutic procedures, including the different methods of administration of the study drug. Provide data to implement effective therapy and offer constant patients support throughout ALS specific and needed procedures. Evaluate if this support could influence adherence rate of ALS patients to conduct clinical trials as required. Provide information for future studies to create an ALS Clinical Trials multiple-retention-factors adherence scale. Create and implement an ALS-specific pain scale accounting for its impact on daily activities, aiding an interdisciplinary approach of pain management. Identify the best pain management strategies and compliance techniques to address ALS, not merely in clinical trials. Provide the best individualized care for ALS patients improving their quality of life and mental state.
This is a descriptive phenomenological study and data will be analyzed according to Sundler's method. Based on the experience of the researchers and the recommendations proposed by Sandelowski, a total of 20 interviews are estimated in order to reach the theoretical saturation per category of reference. Data collection will be carried out through in-depth semi-structured interviews recorded (13 open-ended questions after the execution of the procedures). conditions: Amyotrophic Lateral Sclerosis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 20 type: ESTIMATED name: Interview measure: Prevalence of experience of unpleasant sensations or pain measure: Study procedure that causes unpleasant sensations or pain measure: Duration of unpleasant sensations or pain caused by the study procedure measure: HADS score measure: ALSFRS score sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Istituto Auxologico italiano IRCSS, San Luca Hospital status: RECRUITING city: Milano zip: 20145 country: Italy name: Martina Sodano role: CONTACT phone: +39-02619111 phoneExt: 2937 email: m.sodano@auxologico.it lat: 45.46427 lon: 9.18951 hasResults: False
<\|newrecord\|> nctId: NCT06325852 id: 22-5772 briefTitle: Directional Bilateral Thalamic Patterned Stimulation (Chronos) overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-04-01 date: 2027-01-01 date: 2024-03-22 date: 2024-03-25 name: Alfonso Fasano class: OTHER name: Boston Scientific Corporation briefSummary: Population Size and Eligible Patients: The investigators aim to recruit 5 to 10 patients with tremors who have previously undergone Ventral Intermedius Deep Brain Stimulation (VIM-DBS) treatment but have experienced early or late loss of benefits. Additionally, the investigators will enroll ten patients with essential tremor who require VIM-DBS surgery. These individuals will undergo bilateral implantation of Boston Scientific Genus Implantable Pulse Generator (IPG) devices, connected to Boston Scientific Cartesia™ 8-contact Directional Leads.
Study Design: This study comprises two distinct phases. Phase 1 is a cross-sectional investigation designed to identify the optimal algorithm for patterned stimulation in the VIM region . Phase 2 is a prospective clinical trial focusing on the assessment of safety and efficacy of bilateral VIM-DBS in patients with essential tremor.
Objectives: The primary objective in Phase 2 is to evaluate the safety and effectiveness of bilateral VIM-DBS in individuals with essential tremor. In Phase 1, the investigators seek to explore the impact of the Chronos programming software on tremor patients who have experienced early or late loss of benefits. conditions: Essential Tremor studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 15 type: ESTIMATED name: DBS programing measure: Tremor Rating Scale (Part A-B) measure: Tremor analysis measure: Tremor Rating Scale (A-C) measure: Tremor analysis (meter per second squared) measure: Gait speed (meter per second) measure: Base of support (meter) measure: Step length (meter) measure: Stride length (meter) measure: Single stance time and double stance time (seconds) measure: Tandem gait measure: Posturography (newtons) measure: Quality of life in Essential Tremor Questionnaire (QUEST) measure: Speech analysis sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Movement Disorders Centre - Toronto Western Hospital city: Toronto state: Ontario zip: M5T 2S8 country: Canada name: Alfonso Fasano, MD, PhD role: CONTACT phone: (416) 603-5800 phoneExt: 5961 email: alfonso.fasano@uhn.ca lat: 43.70011 lon: -79.4163 hasResults: False
<\|newrecord\|> nctId: NCT06325839 id: GRU-SBF-ES-01 briefTitle: Effects of HypnoBirthing Training and Oxytocin Massage in Primiparous Pregnants overallStatus: COMPLETED date: 2023-04-01 date: 2023-09-10 date: 2023-09-10 date: 2024-03-22 date: 2024-03-22 name: Giresun University class: OTHER briefSummary: This study was conducted to determine the effects of hypnobirthing training and oxytocin massage on birth and postpartum period in primiparous pregnant women. conditions: Pregnancy Related studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The research is an experimental study with a randomized control group. primaryPurpose: SUPPORTIVE_CARE masking: SINGLE maskingDescription: Pregnant women included in the study were randomly divided into two groups using the sealed envelope method. whoMasked: PARTICIPANT count: 50 type: ACTUAL name: HypnoBirthing training and oxytocin massage group measure: Wijma Birth Anticipation/Experience Scale A (W-DEQ-A) measure: Wijma Birth Expectancy/Expectation Scale B (W-DEQ-B) measure: Postpartum Breastfeeding Self-Efficacy Scale - Short Form measure: Mother-Infant Attachment Scale (MICS) measure: Birth satisfaction scale short form (BSS-SF) sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Giresun Gynecology and Children's Diseases Hospital city: Giresun state: Center zip: 28200 country: Turkey lat: 40.91698 lon: 38.38741 hasResults: False
<\|newrecord\|> nctId: NCT06325826 id: GES briefTitle: The Study of the Validation of General Evaluation Score (GES) in the Prediction of Hepatocellular Carcinoma Risk Among Patients With Advanced Fibrosis and Cirrhosis Who Achieved Sustained Virological Response for Hepatitis C Virus After Direct Acting Antiviral Drugs overallStatus: ACTIVE_NOT_RECRUITING date: 2022-02-01 date: 2023-06-30 date: 2025-06-30 date: 2024-03-22 date: 2024-03-26 name: Egyptian Liver Hospital class: OTHER briefSummary: This cohort study aims to evaluate the validation of general evaluation score in the prediction of hepatocellular carcinoma risk among patients with advanced fibrosis (F3) and cirrhosis (F4) who achieved sustained virological response for hepatitis c virus after direct acting antiviral drugs and determine the group of these patients who require intensified surveillance. conditions: Hepatocellular Carcinoma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 500 type: ACTUAL name: General Evaluation Score (GES) measure: Hepatocellular Carcinoma sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Egyptian Liver Hospital city: Talkha state: Dakahlia zip: 36681 country: Egypt lat: 31.0539 lon: 31.37787 hasResults: False
<\|newrecord\|> nctId: NCT06325813 id: CIN001 - ADHD PreSMART briefTitle: ADHD PreSMA Response Inhibition Therapy overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-06-30 date: 2026-12-31 date: 2024-03-22 date: 2024-03-22 name: Children's Hospital Medical Center, Cincinnati class: OTHER briefSummary: ADHD children have abnormal inhibitory control, meaning they have trouble stopping themselves from doing something they should not do. This ability to control involves an area in the brain called the pre-supplementary motor area (pre-SMA). Scientists have previously shown that the pre-SMA is abnormal in ADHD patients. In this study, we will use Transcranial Magnetic Stimulation (TMS) to stimulate the pre-SMA and determine the effects on measures that are related to inhibitory control. conditions: Attention Deficit Hyperactivity Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: Active repetitive TMS name: Sham repetitive TMS measure: TMS-based Short-Interval Intracortical Inhibition (SICI) measure: EEG-based beta activity measure: TMS-based Cortical Silent Period (cSP) measure: EEG-based alpha activity measure: Stop Signal Reaction Time sex: ALL minimumAge: 12 Years maximumAge: 17 Years stdAges: CHILD hasResults: False
<\|newrecord\|> nctId: NCT06325800 id: 2021401/2023007 id: Grant type: OTHER_GRANT domain: Juan Rodés Grant (JR23/00018) briefTitle: Glycoxidation, Arterial Biomechanics, and Target Organ Damage acronym: GlycOxiTod overallStatus: RECRUITING date: 2024-01-01 date: 2024-12-31 date: 2029-12-31 date: 2024-03-22 date: 2024-04-09 name: Complejo Hospitalario Universitario de Santiago class: OTHER name: Instituto de Investigación Sanitaria de Santiago de Compostela name: Instituto de Salud Carlos III name: University of Santiago de Compostela name: Hospital de Barbanza briefSummary: Vascular target organ damage (TOD), defined as structural or functional deleterious changes in large and small arteries, is related to unfavorable arterial biomechanics, atherosclerosis and arteriosclerosis. Endothelial dysfunction due to unfavorable redox and glycation states on the bases of these phenomena. However, little is known about the role of glycoxidation on arterial biomechanics and TOD in apparently healthy individuals. The main hypothesis is that glycation and glycoxidation status are associated with arterial biomechanical abnormalities and TOD in patients with moderate to high cardiovascular risk. This is an observational, ambispective, and multicenter project that will include non-smoking patients over 18 years, without diabetes mellitus or established cardiovascular disease. Demographic, epidemiological, and clinical-anthropometric variables will be collected, including data from ambulatory blood pressure monitoring. The investigators will measure the serum percentage of glycated hemoglobin, glycated albumin, and fructosamine levels; along with quantification of skin advanced glycation and glycoxidation end productos (AGEs). Plasma concentration, activity, and structure of catalase, glutathione peroxidase, and superoxide dismutase in relation to the patient's glycation and glycoxidation status will be also evaluated. Concurrently, several biomechanical parameters will be assessed in the Common, Internal Carotid Artery, and distal limb arteries using ultrasound exploration. Incipient microvasculature damage will be also evaluated by retinal image. Patients will be followed up for the development of arterial biomechanical abnormalities and TOD, along with cardiovascular events. conditions: Oxidative Stress conditions: Cardiovascular Risk conditions: Target Organ Damage studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: OTHER count: 500 type: ESTIMATED measure: Assessment of redox status (1) measure: Assessment of redox status (2) measure: Evaluation of glycation status (1) measure: Evaluation of glycation status (2) measure: Evaluation of glycation status (3) measure: Evaluation of glycation status (4) measure: Assessment of Glycoxidation status (1) measure: Assessment of Glycoxidation status (2) measure: Quantification of arterial targen organ damage (TOD) during the follow-up (1) measure: Quantification of arterial targen organ damage (TOD) during the follow-up (2) measure: Evaluation of cardiovascular disease during the follow-up sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Complejo Hospitalario Universitario de Santiago de Compostela status: RECRUITING city: Santiago De Compostela state: A Coruña zip: 15706 country: Spain name: Nestor Vazquez Agra, PhD role: CONTACT phone: 0034981950000 email: nestor.vazquez.agra@sergas.es name: Nestor Vazquez-Agra, PhD role: PRINCIPAL_INVESTIGATOR name: Ana-Teresa Marques-Afonso, MD role: SUB_INVESTIGATOR name: Sofia Barbosa-Gouveia, PhD role: SUB_INVESTIGATOR name: Anton Cruces-Sande, PhD role: SUB_INVESTIGATOR name: Carla Diaz-Louzao, PhD role: SUB_INVESTIGATOR name: Iago Carballo, PhD role: SUB_INVESTIGATOR name: Lucia Barrera-Lopez, MD role: SUB_INVESTIGATOR name: Adela Lama-López, MD role: SUB_INVESTIGATOR name: Lucia Gomez-Suarez, MD role: SUB_INVESTIGATOR name: Ivan Fernandez-Castro, MD role: SUB_INVESTIGATOR name: Clara Casar-Cocheteux, MD role: SUB_INVESTIGATOR name: Alvaro Hermida-Ameijeiras, PhD role: SUB_INVESTIGATOR name: Arturo Gonzalez-Quintela, PhD role: SUB_INVESTIGATOR name: Antonio Pose-Reino, PhD role: SUB_INVESTIGATOR name: Francisco Gude-Sampedro, PhD role: SUB_INVESTIGATOR lat: 42.88052 lon: -8.54569 hasResults: False
<\|newrecord\|> nctId: NCT06325787 id: S2021-211-02 briefTitle: Image-guided Thermal Ablation vs. Lobectomy for Solitary Papillary Thyroid Microcarcinoma overallStatus: COMPLETED date: 2013-05-01 date: 2017-01-31 date: 2024-01-31 date: 2024-03-22 date: 2024-03-25 name: Chinese PLA General Hospital class: OTHER briefSummary: To evaluate the clinical outcomes of image-guided thermal ablation versus thyroid lobectomy for the treatment of papillary thyroid microcarcinoma conditions: Papillary Thyroid Cancer studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 1021 type: ACTUAL name: thyroid lobectomy name: image-guided thermal ablation measure: disease progression measure: disease-free survival measure: complications measure: procedure time measure: cost measure: estimated blood loss measure: hospitalization sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06325774 id: Changhai HHospital briefTitle: Radical Hypofractionated Radiotherapy for Localized Prostate Cancer overallStatus: RECRUITING date: 2024-04-01 date: 2026-04-01 date: 2031-04-01 date: 2024-03-22 date: 2024-03-22 name: Changhai Hospital class: OTHER briefSummary: The aim of this trial is to study the safety outcomes of hypofractionated radiotherapy in treating patients with localized prostate cancer.
Hypofractionated radiotherapy delivers higher doses of radiotherapy in a shorter time period, may enabling the killing of more tumor cells with fewer side effects.
Accumulating evidence has proven the safety and feasibility of hypofractionated radiotherapy for localized prostate cancer.But for localized prostate cancer,the optimal dose per fraction of hypofractionated radiotherapy is still on its way. conditions: Localized Prostate Cancer studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: Hypofractionated radiation therapy measure: Incidence of radiotherapy-related gastrointestinal and urogenital tract adverse events measure: biochemical progression-free survival (bPFS) measure: local progression-free-survival(LPFS) measure: distant metastasis free survival(DMFS) measure: Overall survival (OS) measure: Quality of life (QoL) sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Changhai hospital status: RECRUITING city: Shanghai state: Shanghai zip: 200433 country: China name: Huojun Zhang, M.D. role: CONTACT phone: +8613311732399 email: chyyzhj@163.com name: Huojun Zhang, M.D. role: PRINCIPAL_INVESTIGATOR lat: 31.22222 lon: 121.45806 hasResults: False
<\|newrecord\|> nctId: NCT06325761 id: SY-5007-I-02 briefTitle: A Study to Evaluate the Food Effects on Pharmacokinetics of SY-5007 Tablets in Healthy Subjects overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-05-01 date: 2024-05-01 date: 2024-03-22 date: 2024-03-22 name: Shouyao Holdings (Beijing) Co. LTD class: OTHER briefSummary: This study is a single-center, randomized, open-label, single-dose, two-period, two-treatment crossover trial aimed at evaluating the pharmacokinetic (PK) profiles and safety of SY-5007 tablets administered orally to healthy subjects in both fasting and fed states in China. conditions: Health Subjects studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: NONE count: 28 type: ESTIMATED name: SY-5007 name: SY-5007 measure: Cmax for SY-5007 measure: Tmax for SY-5007 measure: AUC0-t for SY-5007 measure: AUC0-∞ for SY-5007 measure: t½ for SY-5007 measure: CL/F for SY-5007 measure: Vz/F for SY-5007 measure: Safety of SY-5007 sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: West China Hospital of Sichuan University city: Chengdu state: Sichuan zip: 610041 country: China name: Li Zheng role: CONTACT phone: 86-28-85423655 email: zhengli@wchscu.cn lat: 30.66667 lon: 104.06667 hasResults: False
<\|newrecord\|> nctId: NCT06325748 id: SENTI-202-101 briefTitle: SENTI-202: Off-the-shelf Logic Gated CAR NK Cell Therapy in Adults With CD33 and/or FLT3 Blood Cancers Including AML/MDS overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2025-09 date: 2040-08 date: 2024-03-22 date: 2024-03-22 name: Senti Biosciences class: INDUSTRY briefSummary: This is an open-label study of the safety, biodynamics, and anti-cancer activity of SENTI-202 (an off-the-shelf logic gated CAR NK cell therapy) in patients with CD33 and/or FLT3 expressing blood cancers, including AML and MDS. conditions: AML/MDS conditions: CD33 Expressing Hematological Malignancies conditions: FLT3 Expressing Hematological Malignancies studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 21 type: ESTIMATED name: SENTI-202 measure: Safety and tolerability for dose determination of SENTI-202 measure: Anti-cancer activity of SENTI-202 measure: Pharmacokinetic (PK) and pharmacodynamic (PDn) profile of SENTI-202 measure: Host immune response to SENTI-202 sex: ALL minimumAge: 18 Years maximumAge: 74 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06325735 id: 98 briefTitle: Combined Systemic Inflammatory Indices and Birth Weight overallStatus: COMPLETED date: 2019-12-01 date: 2021-02-01 date: 2024-04-01 date: 2024-03-22 date: 2024-04-18 name: University of Campania "Luigi Vanvitelli" class: OTHER briefSummary: The study aimed to explore the complex relationship between various systemic inflammatory indices and birth weight conditions: Systemic Inflammation Markers conditions: Birth Weight conditions: Combined Systemic Inflammatory Indices studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 199 type: ACTUAL name: None intervention measure: Systemic inflammatory indices and birth weight sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Università degli studi della Campania "Luigi Vanvitelli"- OB & Gyn - city: Napoli state: Italia zip: 80138 country: Italy lat: 40.85216 lon: 14.26811 hasResults: False
<\|newrecord\|> nctId: NCT06325722 id: 10001680 id: 001680-DK briefTitle: Diet Order Effects of Low Fat vs. Low Carb Diets on Body Fat Change overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-07-31 date: 2026-07-31 date: 2024-03-22 date: 2024-04-26 name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) class: NIH briefSummary: Background:
In a previous study, participants were lived at the NIH and randomly received either a low-fat or a low-carbohydrate diet for 2 weeks and then switched to the other diet for 2 more weeks. Participants who received the low-carbohydrate diet first lost more body fat at the end of the study than those who received the low-fat diet first. Researchers want to see if they can repeat that result in a longer weight loss study when participants live at home.
Objective:
To test the effects of diet order in people receiving either a low-fat or low-carbohydrate diet first for 4 weeks and then immediately switched to the other diet for another 4 weeks.
Eligibility:
Adults aged 19 to 50 years with a body mass index of 25 or more.
Design:
Participants will complete the study at their homes, but there will be 3 required visits to the NIH. Participants will drink a special type of water 2 weeks before the baseline NIH visit and collect urine samples at home to measure how many calories they burn. Before the diets begin, participants will visit the NIH for baseline testing when they will have a metabolism test while relaxing in a bed with a plastic hood over their head to collect the air they breathe out. They will have scans to measure their bone density and how much muscle and body fat they have. They will give stool, blood, and urine samples.
Participants will be asked to eat a specific diet for 4 weeks followed by a different diet for 4 weeks. All meals will be delivered to the participants homes. They will eat only the foods delivered.
Participants will weigh themselves daily. They will wear a monitor to track their physical activity and a sensor to measure their glucose levels. They will prick their finger each morning to test a drop of blood for ketones. Participants will meet virtually as a group with the study team weekly. Participants will have two more NIH visits towards the end of each diet period.... conditions: Overweight conditions: Obesity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: BASIC_SCIENCE masking: SINGLE whoMasked: PARTICIPANT count: 100 type: ESTIMATED name: Low-carbohydrate Diet name: Low-fat Diet measure: Change in total fat mass measure: Rate of body weight change from baseline to week 8 measure: Rate of body weight change during low-carbohydrate diet measure: Rate of body weight change during low-fat diet sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: National Institutes of Health Clinical Center city: Bethesda state: Maryland zip: 20892 country: United States name: Kevin Hall, Ph.D. role: CONTACT phone: 301-402-8248 email: kevinh@niddk.nih.gov lat: 38.98067 lon: -77.10026 hasResults: False
<\|newrecord\|> nctId: NCT06325709 id: 10001580 id: 001580-I briefTitle: Base Editing for Mutation Repair in Hematopoietic Stem & Progenitor Cells for X-Linked Chronic Granulomatous Disease overallStatus: ENROLLING_BY_INVITATION date: 2024-04-17 date: 2032-12-31 date: 2032-12-31 date: 2024-03-22 date: 2024-04-26 name: National Institute of Allergy and Infectious Diseases (NIAID) class: NIH briefSummary: Background:
Chronic granulomatous disease (CGD) is a rare immune disorder caused by a mutation in the CYBB gene. People with CGD have white blood cells that do not work properly. This places them at risk of developing infections that may be life-threatening. Stem cell transplant can cure CGD but transplanting stem cells donated by other people can have serious complications. In addition, not everyone has a matched donor. Another approach is a type of gene therapy that involves base-editing to correct the mutation in a person s own stem cells. Researchers want to know if the base-edited stem cells can improve the white cells' functioning and result in fewer CGD-related infections.
Objective:
To learn if base-edited stem cells will improve white blood cells' ability to fight against infections in people with CGD.
Eligibility:
Males aged 18 years and older with X-linked CGD.
Design:
This is a non-randomized study. Participants with the specific mutation under study will be screened during the initial phase.

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