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<\|newrecord\|> nctId: NCT06291077 id: 2021/0391/HP briefTitle: Comparison of the Effects of Belatacept and Anticalcineurins on Endothelial Function in Renal Transplant Patients - <BELAFENDO> acronym: BELAFENDO overallStatus: NOT_YET_RECRUITING date: 2025-01-01 date: 2028-01-01 date: 2028-01-01 date: 2024-03-04 date: 2024-03-04 name: University Hospital, Rouen class: OTHER briefSummary: Kidney transplantation is the standard treatment for patients with end-stage renal failure.
However, anticalcineurin inhibitors, the most widely used immunosuppressants, are involved in the occurrence of cardiovascular events, a major cause of premature death in these patients. They play an important role in the occurrence of endothelial dysfunction and increased arterial stiffness by decreasing the synthesis of nitric oxide (NO), promoting intrarenal arterial vasoconstriction and stimulating the production of pro-inflammatory cytokines. leading to the development of hypertension and chronic graft dysfunction.
Belatacept, a more recently developed immunosuppressant and co-stimulation signal inhibitor, has shown an anti-rejection effect similar to cyclosporine with a better cardiovascular tolerance profile. Preliminary studies are contradictory on the influence of Belatacept on arterial stiffness. Furthermore, to date, no study has evaluated the impact of Belatacept on vasomotor endothelial function in humans, an indicator of NO bioavailability. The interest of this study is to demonstrate that patients taking Belatacept have an improvement in vascular function compared to patients taking anticalcineurins in order to consider an earlier change in immunosuppressive strategy in the event of vascular damage. conditions: Kidney Diseases studyType: INTERVENTIONAL phases: PHASE4 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 44 type: ESTIMATED name: Belatacept name: anticalcineurins measure: Replacement of anticalcineurins with Belatacept in kidney transplant patients allows an improvement in the endothelium-dependent dilation of peripheral conductance arteries sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06291064 id: IRB23-0678 briefTitle: Trial Studying Chemotherapy in Nigerian Women With Triple Negative Breast Cancer acronym: TARMAC overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2029-06 date: 2032-06 date: 2024-03-04 date: 2024-03-04 name: University of Chicago class: OTHER briefSummary: The primary purpose of this study is to determine what proportion of participants will achieve complete pathological response with epirubicin+ cyclophosphamide followed by docetaxel +carboplatin. This will also examine the potential of using signals in the blood (biomarkers) to identify resistance to chemotherapy in Nigerian women with triple negative breast cancer (TNBC).
All enrollment to this trial will occur at sites in Nigeria. University of Chicago is serving as coordinating center and will be involved in data analysis. conditions: Triple Negative Breast Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 85 type: ESTIMATED name: Cyclophosphamide name: Epirubicin name: Docetaxel name: Carboplatin name: Breast Surgery name: Capecitabine measure: Percentage of Participants that Achieve Pathologic Complete Response (pCR) Rate (Breast) measure: Percentage of Participants that Achieve Pathologic Complete Response (pCR) Rate (Lymph Nodes) measure: Percentage of Participants that Achieve Pathologic Complete Response (pCR) Rate (By Stage) measure: Side Effects of the Study Pre-surgery Chemotherapy Regimen measure: Clinical Response measure: Progressive Disease measure: Invasive Disease Free Survival (iDFS) measure: Duration of Response measure: Heart Related Side Effects of the Pre-Surgery Chemotherapy Regimen sex: FEMALE minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06291051 id: 2021/0382/HP briefTitle: Evaluation of the Safety of Electrical Spinal Cord Stimulation in Parkinson's Patients Presenting With Painful Camptocormia acronym: CAMPTOSTIM overallStatus: NOT_YET_RECRUITING date: 2024-10-01 date: 2028-01-01 date: 2028-01-01 date: 2024-03-04 date: 2024-03-04 name: University Hospital, Rouen class: OTHER briefSummary: Camptocormia is defined by abnormal flexion of the trunk, not fixed, present when standing and walking, resolves when lying down and often complicated by lower back pain. It can be observed in numerous neurological pathologies with a prevalence ranging between 5 and 19% in Parkinson's disease. The physiopathology of camptocormia associated with PD is not completely elucidated, however several mechanisms are discussed, including muscular hypertonia, abdominal muscle dystonia, proprioceptive deficit, iatrogenics linked to dopamine agonists, and focal myopathy. Although its impact is major and greater than the main symptoms of the disease, no specific treatment has been the subject of a marketing authorization request in this indication. Its management remains difficult and usually consists of: adjusting the antiparkinsonian treatment, reducing or even eliminating dopamine agonists, resorting to botulinum toxin injections and rehabilitation, sometimes with the use of a corset. However, the results observed are most often disappointing. The benefit of more invasive techniques, such as deep brain stimulation, classically proposed in advanced forms at the stage of motor complications of PD, is discussed by certain authors. Numerous studies thus suggest that bilateral stimulation of the NST could have a significant but moderate beneficial effect on postural disorders associated with PD, in particular on camptocormia. Likewise, the results of a retrospective study recently conducted in 36 Parkinson's patients discuss the effectiveness of bi-pallidal stimulation. Furthermore, surgical interventions by arthrodesis remain invasive and cause more frequent complications in Parkinson's patients with camptocormia compared to patients with isolated degenerative spinal pathology.
Electrical spinal cord stimulation (ESS) is a validated technique in the management of chronic neuropathic pain. Several publications suggest that it could be effective on postural disorders in PD. Thus, authors report the case of a Parkinson's patient afflicted with painful camptocormia refractory to drug treatments and deep brain stimulation who benefited from EMS with a remarkable effect on pain, walking and posture. This observation is corroborated by data collected in 3 Parkinson's patients with camptocormia subjected to EMS with a beneficial effect on painful and motor symptoms. The mechanism of action could be linked to the correction of the proprioceptive deficit via ascending stimulation of the basal ganglia. On the other hand, the effectiveness of repetitive spinal cord magnetic stimulation was evaluated in a study carried out in 37 patients with camptocormia associated with PD. conditions: Parkinson Disease studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 6 type: ESTIMATED name: Electrical spinal cord stimulation measure: Evaluation of the safety of electrical spinal cord stimulation in Parkinson's patients with painful camptocormia sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06291038 id: 2021/0381/HP briefTitle: Efficacy of Glutamine Supplementation in Patients Suffering From Irritable Bowel Syndrome With Impaired Intestinal Permeability acronym: MISSISIIPI overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2029-03-01 date: 2029-03-01 date: 2024-03-04 date: 2024-03-04 name: University Hospital, Rouen class: OTHER briefSummary: Irritable bowel syndrome (IBS) affects approximately 5% of the general population and remains a daily problem in the practice of clinicians with inconsistent effectiveness of treatments while patients' expectations are high.
One of the functional abnormalities described during IBS is increased intestinal permeability. This increase in intestinal permeability is primarily present in the diarrheal subtype (IBS-D) and can be measured using the lactulose/mannitol test.
Glutamine is a non-essential amino acid which regulates numerous metabolic pathways, and which plays a key role in the intestine because it is the preferential substrate of enterocytes and immune cells. Ex vivo, glutamine is able to restore the expression of tight junction proteins in patients suffering from IBS-D. On the other hand, glutamine supplementation is capable of reducing abdominal pain and restoring intestinal permeability disorders in a subgroup of patients with intestinal permeability disorder (post-infectious IBS-D).
Our working hypothesis would be that all patients suffering from IBS with permeability disorder, measured by the lactulose/mannitol test, could benefit from oral glutamine supplementation. conditions: Irritable Bowel Syndrome studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Multicentric; prospective; randomized; double blind; interregional primaryPurpose: TREATMENT masking: SINGLE maskingDescription: double blind whoMasked: PARTICIPANT count: 60 type: ESTIMATED name: • Experimental group: treatment with glutamine at a dose of 5g 3 times a day for 8 weeks name: • Control group: treatment with a protein powder (Protifar) (Placébo) 5g 3 times a day for 8 weeks. measure: Evaluate the symptomatic effectiveness of glutamine supplementation in patients suffering from IBS-D with increased intestinal permeability sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06291025 id: 2021/0374/HP briefTitle: Efficacy and Safety of Immunosuppression, Caplacizumab and Plasma Infusion Without Therapeutic Plasma Exchange in Immune-mediated Thrombotic Thrombocytopenic Purpura: Multicentric Non-inferiority Single-arm Study acronym: PEX-FREE overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-08-01 date: 2026-08-01 date: 2024-03-04 date: 2024-03-04 name: University Hospital, Rouen class: OTHER briefSummary: Immune thrombotic thrombocytopenic purpura (iTTP) is caused by a severe, autoantibody-mediated deficiency of ADAMTS13 leading to an accumulation of ultra-large von Willebrand factor multimers in plasma and finally to microthrombi in blood vessels. The current standard of care of iTTP consists in the triple association of daily plasma exchange (PEX, 60 ml/kg/day), immunosuppressive agents and anti-adhesive treatment (Caplacizumab). Our group recently reported the outcome of 90 patients with iTTP treated with this triple association and when compared to historical patients, the triplet regimen prevented death, refractoriness and exacerbations. Likewise, plasma volumes were reduced by 2 to 3-fold and we could reduce the median number of PEX sessions from 13 to 6. PEX is an invasive and time-consuming procedure, associated with catheter and plasma-related complications ranging from 22% to 30%. Consequently, to alleviate the burden of care in iTTP, using a regimen without PEX would represent a major and topical goal. Attempts to treat patients with plasma infusion (PI) without PEX were previously reported and provided evidence that large volumes of PI (20-30 ml/kg/day) improved the initial outcome of iTTP. However, fluid overload occurred in most cases after 5-7 days, limiting the feasibility of this strategy. Nevertheless, the recent availability of caplacizumab opens the perspective of treating patients with plasma for a shorter period. Recently, strategies without PEX have been carried out in Jehovah's Witnesses with iTTP \[5\]. Impressively, improvement was rapid and comparable to those provided with a standard PEX-based treatment. Additionally, a treatment combining caplacizumab and immunosuppression only was successfully performed in six iTTP patients with severe neurologic and/or cardiac involvement. The rapid and durable improvement provides evidence that a regimen without plasma seems feasible. However, we consider that robust data are still lacking to completely remove plasmatherapy from iTTP management. Based on these statements, we wish here to address the efficacy and safety of a PEX-free regimen, combining PI only (15 ml/kg/day), corticosteroids/rituximab, and caplacizumab. conditions: Thrombotic Microangiopathies studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: This trial is prospective, non-comparative, non-inferiority, single-arm, multicentric, national. primaryPurpose: TREATMENT masking: NONE count: 131 type: ESTIMATED name: PEX-FREE measure: To evaluate the efficacy of a PEX-FREE regimen in adults with iTTP as assessed by the proportion of participants day-30 post-plasma therapy death, refractoriness, exacerbation or an ADAMTS13 activity < 20%. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06291012 id: RECHMPL22_0399 id: 2024-512236-30-00 type: REGISTRY domain: EUCT Number briefTitle: Stopping Pneumonia Antibiotherapy Regimen Early acronym: SPARE overallStatus: NOT_YET_RECRUITING date: 2024-09-01 date: 2027-05-01 date: 2027-09-01 date: 2024-03-04 date: 2024-03-04 name: University Hospital, Montpellier class: OTHER name: Direction Générale de l'Offre de Soins briefSummary: The hypothesis for this trial is that an antibiotic strategy for the management of non-severe community-acquired alveolar pneumonia in children aged 3 to 59 months, including amoxicillin 80-100 mg/kg/day for at least 3 days in case of rapid response and 5 days in case of delayed response, would not be inferior to current French recommendations (antibiotic therapy for 5 days in case of rapid response and 7 days in case of delayed response) in terms of treatment of failure rate at 7 days. conditions: Community-acquired Pneumonia conditions: Child, Only studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The randomization will be carried out by minimization with stratification on the investigating center and age (\< 1 year and ≥ 1 year) primaryPurpose: TREATMENT masking: SINGLE whoMasked: CARE_PROVIDER count: 1100 type: ESTIMATED name: Quick response: Amoxicillin for 3 days name: Delayed response: Amoxicillin for 5 days name: Quick response: Amoxicillin for 5 days name: Delayed response: Amoxicillin for 7 days measure: Therapeutic failure rate D7 measure: Therapeutic failure rate on D30 measure: Adverse effects measure: Compliance measure: Duration of antibiotic therapy sex: ALL minimumAge: 3 Months maximumAge: 59 Months stdAges: CHILD facility: CHU de Montpellier city: Montpellier zip: 34295 country: France name: Sarah DUTRON, MD role: CONTACT name: Sarah DUTRON, MD role: PRINCIPAL_INVESTIGATOR name: Eric JEZIORSKI, MD PhD role: SUB_INVESTIGATOR lat: 43.61092 lon: 3.87723 hasResults: False
<\|newrecord\|> nctId: NCT06290999 id: CHUBX 2023/80 briefTitle: Study of Multifrequential Impedancemetry in Pulsatile Tinnitus acronym: MADMAN overallStatus: NOT_YET_RECRUITING date: 2024-03-15 date: 2025-09-15 date: 2025-12-15 date: 2024-03-04 date: 2024-03-04 name: University Hospital, Bordeaux class: OTHER briefSummary: This study intended to search for a relationship between the multifrequential admittancemetry and the pulsatile tinnitus. conditions: Pulsatile Tinnitus studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 50 type: ESTIMATED name: multifrequential admittancemetry measure: Multifrequency admittancemetry measure: compression maneuvers measure: Evaluation of the effect of interventional radiology measure: success of radiointerventional treatment sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Bordeaux University Hospital city: Bordeaux zip: 33000 country: France name: Balthazar CROC role: CONTACT email: balthazar.croc@chu-bordeaux.fr name: Valérie FRANCO-VIDAL, Pr role: CONTACT phone: 0556795609 email: valerie.vidal@chu-bordeaux.fr lat: 44.84044 lon: -0.5805 hasResults: False
<\|newrecord\|> nctId: NCT06290986 id: Pyrocardan® RCT briefTitle: Pyrocardan® Implant Arthroplasty or LRTI for Trapeziometacarpal Osteoarthritis overallStatus: RECRUITING date: 2022-09-26 date: 2025-09-30 date: 2025-09-30 date: 2024-03-04 date: 2024-03-04 name: Herlev and Gentofte Hospital class: OTHER briefSummary: This is a randomized controlled trial comparing the Pyrocardan® implant (intervention group) with the standard ligament reconstruction and tendon interposition (LRTI) (control group). All Danish citizens with osteoarthritis of the thumb carpometacarpal joint referred to the orthopedic department at Copenhagen University Hospital in Herlev/Gentofte will be considered for participation in the trial. The following exclude from participation in the study: Below 40 years of age; cognitive or linguistic impairment; osteoarthritis of other carpal bones; previous surgery in the carpometacarpal joint; patients with rheumatoid arthritis. A total of 64 patients will be included. The primary outcome is the patient reported outcomes questionnaire; Quick-DASH. The secondary outcomes are patient-reported outcomes, functional outcomes, radiographic outcomes, readmission, complications, revisions. The patients are examined before surgery and 3, 6, 12 and 24 months after the operation. The patients are also contacted after 5 and 10 years. conditions: CMC-1 Osteoarthritis conditions: Trapeziometacarpal Osteoarthritis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 64 type: ESTIMATED name: Pyrocardan® implant name: Ligament reconstruction and tendon interposition (LRTI) measure: Patient-reported outcome: QuickDASH measure: Patient-reported outcome measure: Strength measurements measure: Radiographs measure: Return to occupation sex: ALL minimumAge: 40 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Herlev and Gentofte Hospital status: RECRUITING city: Hellerup zip: 2900 country: Denmark name: Jens Jørgsholm, MD role: CONTACT phone: +4551339705 email: Jens.bertel.joergsholm.01@regionh.dk name: Rasmus Wejnold Jørgensen, MD, PhD role: CONTACT phone: +4538673315 email: rasmus.wejnold.joergensen@regionh.dk lat: 55.73204 lon: 12.57093 hasResults: False
<\|newrecord\|> nctId: NCT06290973 id: PI-23-3017 briefTitle: Quality of Life and Health Perception After Surgery of Varicose Veins overallStatus: COMPLETED date: 2023-01-02 date: 2023-02-28 date: 2023-11-14 date: 2024-03-04 date: 2024-03-04 name: Hospital Clínico Universitario de Valladolid class: OTHER briefSummary: The aim of this study is to analyze changes in health perception and quality of life in patients after surgery for varicose veins using clinical score VCSS and QoL scores SF12 as general health questionary and Veines QoL/Sym as disease specific questionary. conditions: Quality of Life conditions: Varicose Veins studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 58 type: ACTUAL name: surgery of varicose veins measure: changes in qol questionarie SF-12 after surgery of varicose veins measure: changes in qol questionarie Veines QoL/Sym after surgery of measure: changes in VCSS after surgery of varicose veins sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital CLínico Universitario de Valladolid city: Valladolid country: Spain lat: 41.65518 lon: -4.72372 hasResults: False
<\|newrecord\|> nctId: NCT06290947 id: BFR-AE-DT2-2023-01 id: IRB 2022/C/20/N type: OTHER_GRANT domain: AAUP briefTitle: BFR Walking for Insulin and Aerobic Improvement in Type 2 Diabetes acronym: BRAID overallStatus: COMPLETED date: 2022-03-06 date: 2023-12-20 date: 2024-01-08 date: 2024-03-04 date: 2024-03-04 name: Arab American University (Palestine) class: OTHER briefSummary: This clinical trial examines the impact of Blood-Flow Restriction Walk Training (BFRw) on insulin sensitivity and aerobic capacity in individuals with Type 2 Diabetes (T2D).
The primary objectives of the study are to determine: If Blood-Flow Restriction Walk Training (BFRw) can improve insulin sensitivity in individuals with Type 2 Diabetes (T2D).
Whether Blood-Flow Restriction Walk Training (BFRw) enhances aerobic capacity in individuals with Type 2 Diabetes (T2D).
Participants in the study are divided into two groups. One group undergoes Blood-Flow Restriction Walk Training (BFRw), and the other serves as a control. Both groups attend three treadmill walking sessions weekly for eight weeks. The BFRw group has a restriction cuff placed around both thighs during their sessions, while the control group participates in the walking sessions without any blood flow restriction.
Hemoglobin A1c (HbA1c) levels and maximal oxygen consumption (VO2 max) are monitored as indicators of insulin sensitivity and aerobic capacity, respectively. conditions: Type 2 Diabetes Mellitus studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This study employs a randomized controlled trial model with a parallel assignment to evaluate the efficacy of Blood-Flow Restriction Walk Training compared to a control condition. Participants are randomly allocated into two groups: one receiving the intervention (BFR walk training) and the other serving as a control (usual walk training). This design allows for the direct comparison of outcomes between the intervention and control groups over the study period. primaryPurpose: SUPPORTIVE_CARE masking: NONE maskingDescription: None (Open Label) count: 60 type: ACTUAL name: BFR Cuffs for Intervention Group name: Standard Walking Training Program measure: Improvement in Insulin Sensitivity measure: Improvement in Aerobic Capacity measure: Change in Body Mass Index (BMI) sex: MALE minimumAge: 40 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Arab American University - Palestine city: Jenin zip: P.O Box 24 country: Palestinian Territory, occupied lat: 32.45943 lon: 35.30086 hasResults: False
<\|newrecord\|> nctId: NCT06290934 id: GS-US-409-5704 id: 2023-508304-38 type: OTHER domain: European Medicines Agency briefTitle: Study of GS-1427 in Participants With Moderately to Severely Active Ulcerative Colitis acronym: SWIFT overallStatus: RECRUITING date: 2024-03-27 date: 2027-05 date: 2028-03 date: 2024-03-04 date: 2024-04-23 name: Gilead Sciences class: INDUSTRY briefSummary: The goal of this study is to learn if GS-1427 is effective and safe in treating participants with moderate to severe ulcerative colitis. The study will compare participants in different treatment groups treated with GS-1427 with participants treated with placebo (Part 1), and participants treated with GS-1427 or ustekinumab alone with participants treated with GS-1427 in combination with ustekinumab (Part 2).
The primary objectives of this study are:
Part 1: To assess the efficacy of GS-1427, compared with placebo control, in achieving clinical response at Week 12
Part 2: To assess the efficacy of combination therapy with GS-1427 and ustekinumab, compared with GS-1427 and ustekinumab monotherapies, in achieving clinical response at Week 12 conditions: Ulcerative Colitis studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 423 type: ESTIMATED name: GS-1427 name: Ustekinumab name: Placebo-to-match GS-1427 measure: Parts 1 and 2: Proportion of Participants Achieving Clinical Response at Week 12 measure: Part 2: Proportion of Participants Achieving Clinical Response at Week 24 measure: Parts 1 and 2: Incidence of Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), or Deaths. measure: Parts 1 and 2: Incidence of Treatment-emergent Lab Abnormalities measure: Parts 1 and 2: Proportion of Participants Achieving Clinical Remission at Week 12 measure: Part 1: Proportion of Participants Achieving Clinical Remission at Week 52 measure: Part 2: Proportion of Participants Achieving Clinical Remission at Week 24 measure: Part 2: Proportion of Participants Achieving Partial Modified Mayo Score Remission at Week 52 measure: Parts 1 and 2: Proportion of Participants Achieving Histologic-endoscopic Mucosal Improvement at Week 12 measure: Part 2: Proportion of Participants Achieving Histologic-endoscopic Mucosal Improvement at Week 24 measure: Parts 1 and 2: Proportion of Participants Achieving Mucosal Healing at Week 12 measure: Part 2: Proportion of Participants Achieving Mucosal Healing at Week 24 measure: Parts 1 and 2: Proportion of Participants Achieving Endoscopic Improvement at Week 12 measure: Part 2: Proportion of Participants Achieving Endoscopic Improvement at Week 24 sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Om Research LLC status: RECRUITING city: Camarillo state: California zip: 93010 country: United States lat: 34.21639 lon: -119.0376 facility: VVCRD Research status: RECRUITING city: Garden Grove state: California zip: 92845 country: United States lat: 33.77391 lon: -117.94145 facility: Om Research LLC status: RECRUITING city: Lancaster state: California zip: 93534 country: United States lat: 34.69804 lon: -118.13674 facility: United Medical Doctors status: RECRUITING city: Murrieta state: California zip: 92563 country: United States lat: 33.55391 lon: -117.21392 facility: Encore Medical Research. LLC status: RECRUITING city: Hollywood state: Florida zip: 33021 country: United States lat: 26.0112 lon: -80.14949 facility: Encore Medical Research of Weston, LLC status: RECRUITING city: Weston state: Florida zip: 33331 country: United States lat: 26.10037 lon: -80.39977 facility: Clinical Research Institute of Michigan, LLC. status: RECRUITING city: Chesterfield state: Michigan zip: 48047 country: United States lat: 42.66281 lon: -82.84242 facility: Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinical Research Center. status: RECRUITING city: Wyoming state: Michigan zip: 49519 country: United States lat: 42.91336 lon: -85.70531 facility: Quality Medical Research status: RECRUITING city: Nashville state: Tennessee zip: 37211 country: United States lat: 36.16589 lon: -86.78444 facility: Southwest Clinical Trials status: RECRUITING city: Houston state: Texas zip: 77074 country: United States lat: 29.76328 lon: -95.36327 facility: Southern Star Research Institute, LLC. status: RECRUITING city: San Antonio state: Texas zip: 78229 country: United States lat: 29.42412 lon: -98.49363 facility: Tyler Research Institute, LLC. status: RECRUITING city: Tyler state: Texas zip: 75701 country: United States lat: 32.35126 lon: -95.30106 hasResults: False
<\|newrecord\|> nctId: NCT06290921 id: 3472 briefTitle: Ovulation Triggering 2 vs 3 Follicles overallStatus: ACTIVE_NOT_RECRUITING date: 2024-02-22 date: 2024-12-31 date: 2025-02-20 date: 2024-03-04 date: 2024-03-04 name: Clinique Ovo class: INDUSTRY briefSummary: Poor responders in in-vitro fertilization (IVF) cycles represent a major challenge for fertility specialists. Although poor responders tend to have sub-optimal fertility treatment outcomes, many of these patients wish to attempt at least one IVF cycle. Traditionally, IVF cycles producing less than 3 to 4 mature follicles (measuring at least 14 mm) have either been cancelled or converted to intra-uterine insemination (IUI) due to the low pregnancy rates associated with these cycles. The minimal number of follicles required to proceed with egg collection is based on clinical experience, having been determined by weighing the probability of implantation and pregnancy versus the risk of not obtaining quality oocytes or reaching embryo transfer when fewer mature follicles are present. This retrospective quality control study aims to compare pregnancy rates in IVF cycles producing 3 follicles measuring 14 mm and more on trigger day, versus 2 or fewer follicles. conditions: Infertility studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 400 type: ESTIMATED name: Ovulation triggering measure: Clinical Pregnancy Rate sex: FEMALE minimumAge: 18 Years maximumAge: 42 Years stdAges: ADULT facility: Clinique Ovo city: Montréal state: Quebec zip: H4P 2S4 country: Canada lat: 45.50884 lon: -73.58781 hasResults: False
<\|newrecord\|> nctId: NCT06290908 id: TF2018-001-01 briefTitle: RPE-P/TLIF for Lumbar Spinal Stenosis With Instability overallStatus: COMPLETED date: 2018-09-04 date: 2022-04-30 date: 2024-02-01 date: 2024-03-04 date: 2024-03-04 name: Wen-xi Sun class: OTHER name: Guangdong Provincial Hospital of Traditional Chinese Medicine briefSummary: Objective To analyze the effectiveness and safety of robot-assisted percutaneous endoscopic posterior/transforaminal lumbar interbody fusion (RPE-P/TLIF) in the treatment of lumbar spinal stenosis with instability. Methods A single-center prospective study from September 2018 to April 2022, patients with lumbar spinal stenosis and instability who met the inclusion and exclusion criteria were treated with RPE-P/TLIF. Pain visual analog scale (VAS) was used to evaluate the degree of low back pain and lower limb pain before operation, 1 month, 6 months, 1 year after operation and at the final follow-up, and the Oswestry disability index (ODI) was used to evaluate the degree of lumbar spinal function. At the last follow-up, MacNab criteria were used to evaluate the clinical efficacy. Imaging evaluation included the measurement of intervertebral space height, lumbar physiological curvature, fusion rate and pedicle screw accuracy by preoperative and lateral X-ray films. conditions: Spinal Stenosis studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 26 type: ACTUAL name: RPE-P/TLIF measure: Pain visual analog scale (VAS) measure: Oswestry disability index (ODI) measure: MacNab criteria measure: intervertebral space height measure: lumbar physiological curvature measure: fusion rate measure: pedicle screw accuracy sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Guangdong Provincial Hospital of Traditional Chinese Medicine city: Guangzhou country: China lat: 23.11667 lon: 113.25 hasResults: False
<\|newrecord\|> nctId: NCT06290895 id: 3465 briefTitle: Artificial Oocyte Activation overallStatus: ACTIVE_NOT_RECRUITING date: 2024-02-22 date: 2024-12-31 date: 2025-02-19 date: 2024-03-04 date: 2024-03-04 name: Clinique Ovo class: INDUSTRY briefSummary: Studies reported that calcium signal deficiency or insufficiency during oocyte activation are related with embryo arrest and blastocyst quality. The utilization of Artificial Oocyte Activation (AOA) is safe and does not increase birth defects, cognition, language and motor skills. AOA is the first line of treatment in patients with globozoospermia (round headed spermatozoa). Poor responders in in-vitro fertilization (IVF) cycles represent a major challenge for fertility specialists and comprises about 10-15% of patients undergoing controlled ovarian hyperstimulation. The absence of synergy between the oocyte and sperm leads to a negative impact on oocyte activation. The European Society of Human and REproduction (ESHRE) recommends AOA in cases with failed fertilization/ low fertilization. conditions: Infertility conditions: Ovarian Insufficiency studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 54 type: ACTUAL name: women having had a second IVF cycle with AOA measure: Blastocyst rate sex: FEMALE minimumAge: 18 Years maximumAge: 42 Years stdAges: ADULT facility: Clinique Ovo city: Montréal state: Quebec zip: H4P 2S4 country: Canada lat: 45.50884 lon: -73.58781 hasResults: False
<\|newrecord\|> nctId: NCT06290882 id: ERMA trial briefTitle: Endoscopic Versus Robotic Myotomy for Treatment of Achalasia acronym: ERMA overallStatus: ACTIVE_NOT_RECRUITING date: 2024-01-01 date: 2026-01-31 date: 2027-01-01 date: 2024-03-04 date: 2024-03-05 name: Germans Trias i Pujol Hospital class: OTHER briefSummary: Achalasia is a primary esophageal motor disorder of unknown etiology characterized by degeneration of the myenteric plexus, resulting in impaired relaxation of the esophagogastric junction (EGJ), along with loss of peristalsis in the esophageal body. The standard criteria for diagnosing achalasia is high-resolution esophageal manometry, which shows incomplete relaxation of the EGJ along with absence of esophageal body peristalsis. These anomalies usually cause dysphagia and regurgitation as the main symptoms of this pathology. Different treatment options have been described for this pathology, with pneumatic dilation (PD) and myotomy being considered first-line, whether surgical (laparoscopic Heller myotomy, LHM) or endoscopic (peroral endoscopic myotomy, POEM). The arrival of POEM as a less invasive alternative for the treatment of achalasia has revolutionized expectations to the point that it has become a routine procedure in many centers around the world. In recent years, a large amount of data examining the effectiveness of POEM have appeared, including several meta-analyses. The success rate of POEM in prospective cohorts has been greater than 90%. Two randomized studies have been published comparing POEM with LHM, providing a framework to evaluate the comparative efficacy and safety of these two interventions and to determine which should be first-line for the treatment of these patients. According to these data, it seems that the two procedures offer the same clinical results in the medium term. On the other hand, in recent years, there has been a growing expansion of the application of robot-assisted technology. Robotic Heller myotomy (RHM) has been proposed as an alternative minimally invasive approach to traditional laparoscopy with a lower complication rate. Based on the evidence, POEM and RHM could have comparable results in short term, but there is no clear certainty about the results in medium-long term. Likewise, there is a lack of studies that confirm postoperative reflux results in both procedures.
The purpose of the study is to evaluate the clinical and quality of life results of the RHM and compare them with the results of POEM in treatment of achalasia. conditions: Achalasia Cardia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized controlled trial primaryPurpose: TREATMENT masking: NONE count: 144 type: ACTUAL name: Robotic Heller Myotomy name: Peroral Endoscopic Myotomy measure: Eckhard symptom scores measure: GERD-Q score sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Elisenda Garsot Savall city: Badalona state: Barcelona zip: 08016 country: Spain lat: 41.45004 lon: 2.24741 hasResults: False
<\|newrecord\|> nctId: NCT06290869 id: STUDY00006070 briefTitle: Tobacco Education and Lung Health Study (TEAL) acronym: TEAL overallStatus: RECRUITING date: 2024-02-22 date: 2026-02 date: 2026-04 date: 2024-03-04 date: 2024-03-06 name: Georgetown University class: OTHER briefSummary: Primary Objective To compare two smoking cessation interventions among individuals undergoing lung cancer screening. Primary outcomes are: 3-month self-reported abstinence from cigarettes and 6-month self-reported and bioverified abstinence from cigarettes.
Secondary Objectives 1) To evaluate reach and engagement overall and by subgroup (e.g., race and ethnicity, underinsured, readiness to quit). 2) To conduct an economic analysis to evaluate intervention costs from the health system perspective. conditions: Smoking Cessation studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 1188 type: ESTIMATED name: Phone-based Tobacco Treatment, Nicotine Replacement, and Stepped Care Intervention name: E-Referral to the Tobacco Quitline measure: Biochemically verified smoking abstinence- MHS vs. QL-E arms measure: Biochemically verified smoking abstinence--continued MHS arm vs Stepped Care measure: self-reported smoking status measure: cigarettes per day measure: readiness to quit measure: Patient reach and patient engagement measure: Costs per arm from the health system perspective sex: ALL minimumAge: 50 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Georgetown University Medical Center status: RECRUITING city: Washington state: District of Columbia zip: 20007 country: United States name: Kathryn L Taylor, PhD role: CONTACT phone: 202-215-9402 email: taylorkl@georgetown.edu lat: 38.89511 lon: -77.03637 hasResults: False
<\|newrecord\|> nctId: NCT06290856 id: 651397 briefTitle: Clinical Utility of Selected Circulating Tumor DNA Assays in Patients With Advanced Malignancy overallStatus: RECRUITING date: 2024-01-15 date: 2025-12-15 date: 2025-12-15 date: 2024-03-04 date: 2024-03-07 name: Oslo University Hospital class: OTHER briefSummary: Circulating tumor DNA assays are becoming relevant for routine diagnostics, but many related aspects are yet unresolved. With this project, the investigators aim to develop pragmatic molecular diagnostic pathways of liquid biopsies relevant in advanced gastrointestinal malignancies with focus on clinical utility and sensible use of resources. They want to evaluate the ctDNA assays on a fully automated "low-cost" multiplex platform which is already implemented in routine molecular diagnostics of solid biopsies. The project will evaluate to what extent these ctDNA assays are relevant for clinical decision-making. conditions: Metastatic Colorectal Cancer conditions: Pancreas Adenocarcinoma conditions: Cholangiocarcinoma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: Multiplex PCR-test for circulating tumor DNA measure: Clinical validity of ctDNA tests measure: Resources needed for ctDNA assays in routine diagnostics sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Oslo university Hospital status: RECRUITING city: Oslo country: Norway name: Ragnhild Nome, MD, PhD role: CONTACT lat: 59.91273 lon: 10.74609 hasResults: False
<\|newrecord\|> nctId: NCT06290843 id: AWFiS/2024_1_PE briefTitle: Analysis of Body Balance Parameters in Children With Idiopathic Scoliosis overallStatus: NOT_YET_RECRUITING date: 2024-04-05 date: 2024-05-30 date: 2024-05-30 date: 2024-03-04 date: 2024-04-04 name: Gdansk University of Physical Education and Sport class: OTHER briefSummary: The aim of the study is to compare body balance parameters assessed using the AMTI dynamometric platform in children with idiopathic scoliosis (with and without Schroth therapy) compared to control group. conditions: Idiopathic Scoliosis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 50 type: ESTIMATED name: Schroth method measure: Analysis of body balance on the AMTI force platform measure: Analysis of body balance on the AMTI force platform measure: Analysis of body balance on the AMTI force platform measure: Analysis of body balance on the AMTI force platform measure: Photographic analysis of body posture measure: Analysis of x-ray in the frontal plane measure: Analysis of x-ray in the frontal plane measure: Analysis of x-ray in the frontal plane measure: Analysis of x-ray in the frontal plane measure: Analysis of x-ray in the sagittal plane measure: Analysis of x-ray in the sagittal plane sex: FEMALE minimumAge: 10 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Gdansk University of Physical Education and Sport city: Gdańsk state: Pomorskie zip: 80-336 country: Poland lat: 54.35205 lon: 18.64637 hasResults: False
<\|newrecord\|> nctId: NCT06290830 id: OMUŞükranBaşgöl01 briefTitle: Abdominal Massage and Kegel Exercises on Constipation and Quality of Life in Female Students overallStatus: NOT_YET_RECRUITING date: 2024-03-15 date: 2024-05-31 date: 2024-06-01 date: 2024-03-04 date: 2024-03-12 name: Ondokuz Mayıs University class: OTHER briefSummary: In this prospective, randomized controlled study, n=140 female students with functional constipation studying at two universities Faculty of Health Sciences and meeting the Rome-IV Diagnostic Criteria for Constipation will be included in the study. Between 15.03.2024 and 31.05.2024, n=140 (35=control group, 35=kegel exercise group, 35=abdominal exercise group, 35=abdominal and kegel exercise group) volunteered to participate in the study. Female students with functional constipation will be randomly divided into four groups as intervention and control groups. Personal Information Form", "Bristol Stool Scale", "Constipation Severity Scale", and "Patient Assessment of Constipation Quality of Life Questionnaire" will be used in this study. The scales will be used in the research two times: pre and post-test (scales were reassessed at the end of the study after the exercise intervention). Descriptive statistics, Pearson, and Spearman's correlation analyses will be used in the analysis of research data. conditions: Functional Constipation conditions: Constipation conditions: Quality of Life studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 140 type: ESTIMATED name: Abdominal massage group name: Kegel Exercises group name: Both abdominal massage and kegel exercises to gether measure: Constipation severity change measure: Quality of Life change measure: Bristol stool form score change sex: FEMALE minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT hasResults: False
<\|newrecord\|> nctId: NCT06290817 id: 2023-0724 briefTitle: Orelabrutinib Combined With R-CDOP for DLBCL Patients With High-risk of CNS Relapse Defined by CNS-IPI overallStatus: RECRUITING date: 2023-03-30 date: 2025-03-30 date: 2026-03-20 date: 2024-03-04 date: 2024-03-04 name: Second Affiliated Hospital, School of Medicine, Zhejiang University class: OTHER name: Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University name: Huizhou Municipal Central Hospital name: Ningbo Medical Center Lihuili Hospital name: Affiliated Hospital of Jiaxing University name: The Second Affiliated Hospital of Jiaxing University briefSummary: This is a prospective, multicenter, single-arm clinical study on the treatment of newly diagnosed diffuse large B-cell lymphoma with high-risk of CNS relapse defined by CNS-IPI using Orelabrutinib in combination with R-CDOP regimen. conditions: Diffuse Large B-cell Lymphoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 62 type: ESTIMATED name: Orelabrutinib combined with R-CDOP regimen measure: 2-year central nervous system relapse rate measure: Complete Response Rate measure: Overall Response Rate (ORR) measure: 2-year Overall survival (OS) rate measure: 1-year Overall survival (OS) rate measure: 2-year progression-free survival (PFS) rate measure: 1-year progression-free survival (PFS) rate measure: Occurrence of hematologic adverse events and non-hematologic adverse events according to CTCAE V4.03 measure: Occurrence of adverse events and serious adverse events according to CTCAE V4.03 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Second Affiliated Hospital, School of Medicine, Zhejiang University status: RECRUITING city: Zhejiang state: Zhejiang country: China name: Wenbin Qian role: CONTACT name: Xibin Xiao role: SUB_INVESTIGATOR facility: Huzhou Central Hospital status: RECRUITING city: Huzhou country: China name: Lihong Shou role: CONTACT phone: 13362216921 email: SLH077@126.COM lat: 30.8703 lon: 120.0933 facility: Affiliated hospital of Jiaxing University , the First Hospital of Jiaxing status: RECRUITING city: Jiaxing country: China name: Hui Zeng role: CONTACT phone: 13957330440 email: zhwuhqn@163.com lat: 30.7522 lon: 120.75 facility: Affiliated hospital of Jiaxing University , the Second Hospital of Jiaxing status: RECRUITING city: Jiaxing country: China name: Beili Hu role: CONTACT phone: 0573-82080930 email: 87718916@qq.com lat: 30.7522 lon: 120.75 facility: Ningbo Medical Center LiHuili Hospital status: RECRUITING city: Ningbo country: China name: Jing Le role: CONTACT phone: 13566511755 email: nblejing@aliyun.com lat: 29.87819 lon: 121.54945 facility: Taizhou Hospital of Zhejiang status: RECRUITING city: Taizhou country: China name: Yiqun Guo role: CONTACT phone: 13515861286 email: guoqunyi@163.com lat: 32.49069 lon: 119.90812 hasResults: False
<\|newrecord\|> nctId: NCT06290804 id: drezgiyucel0000000193593877 briefTitle: Assessing Sustainable Behaviors and Health Impacts of Climate Change overallStatus: ACTIVE_NOT_RECRUITING date: 2024-01-15 date: 2024-03 date: 2024-07 date: 2024-03-04 date: 2024-03-04 name: Eskisehir Osmangazi University class: OTHER briefSummary: The relationship between climate change, sustainability and child health is complex and important. These three concepts are interacting factors and have significant impacts on children's health. Sustainability measures are vital to protect child health by mitigating the impacts of climate change. At the same time, children's education and awareness is an important factor that will contribute to future generations living in a sustainable world. As a society, tackling climate change and striving for a sustainable future is crucial to ensure that children live healthy and safe lives. The aim of this study is to evaluate the effectiveness of the education program and educational videos to be applied to children in terms of environmentally sustainable behaviors and awareness of the health effects of climate change in 60-72-month-old children studying in Eskişehir Odunpazarı Municipality Day Care Center and Nurseries. In addition, in this study, it was aimed to measure the level of global climate change awareness of parents and to evaluate the relationship with children's environmentally sustainable behaviors. conditions: Climate Change conditions: Child Health studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: PREVENTION masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 38 type: ESTIMATED name: education measure: increasing sustainable behaviors measure: raising awareness of the health impacts of climate change measure: raising awareness of global climate change sex: ALL minimumAge: 60 Months maximumAge: 72 Months stdAges: CHILD facility: Ezgi Yücel city: Odunpazarı state: Eskişehir zip: 553 723 43 57 country: Turkey lat: 39.76821 lon: 30.53538 hasResults: False
<\|newrecord\|> nctId: NCT06290791 id: K2020214 briefTitle: Does a Drain Tube Influence the Postoperative Epidural Haematoma for Lumbar Biportal Endoscopic Surgery? overallStatus: COMPLETED date: 2020-12-31 date: 2023-12-31 date: 2024-02-10 date: 2024-03-04 date: 2024-03-04 name: The Fourth Affiliated Hospital of Zhejiang University School of Medicine class: OTHER briefSummary: The purpose of this study was to evaluate if wound drains could influence postoperative spinal epidural hematoma (POSEH) in biportal endoscopic spinal surgery (BESS) procedures for decompression of lumbar spinal stenosis. conditions: Drain Tube Influence the Postoperative Epidural Haematoma studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 89 type: ACTUAL name: two level lumbar decompression with BESS procedure received one drain. name: two level lumbar decompression with BESS procedure received two drain. measure: the cross-sectional area of POSEH measure: the volume of drain output sex: ALL minimumAge: 20 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Zhonglin Zhong city: Yiwu state: Zhejiang zip: 322000 country: China lat: 29.31506 lon: 120.07676 hasResults: False
<\|newrecord\|> nctId: NCT06290778 id: Baylor IRB #023-445 briefTitle: Peer Delivered, Emotion Regulation-Focused Mental Health Prevention Training for Fire Fighter Trainees acronym: PEER UP overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2027-08 date: 2027-08 date: 2024-03-04 date: 2024-03-05 name: Baylor Research Institute class: OTHER name: University of Pittsburgh name: Boston University name: Texas A&M University briefSummary: The goal of this clinical trial is to determine if a peer-delivered emotion regulation training (Brief-Unified Protocol) workshop is effective for preventing posttraumatic stress and other psychological health symptoms in firefighter trainees. The main questions it aims to answer are:
* Do firefighter recruits who receive peer-delivered Brief-Unified Protocol report lower PTSD symptom severity over time compared to those who receive psychoeducation?
* Do firefighter recruits who receive peer-delivered Brief-Unified Protocol report lower AUD, depression, anxiety, and functional impairment symptom severity over time compared to those who receive psychoeducation?
* Do changes in neuroticism or emotion regulation mediate the effect of receiving the Brief-Unified Protocol on the treatment outcomes?
Participants will:
* Participate in a Brief-Unified Protocol workshop or psychoeducation workshop during fire academy training.
* Complete a questionnaire and clinical interview prior to the workshop.
* Complete a questionnaire immediately following the workshop and follow up questionnaires at 6, 12, 18, and 24 months after completing the fire academy.
Researchers will compare firefighters who receive a peer-delivered Brief-Unified Protocol workshop to firefighters who receive peer-delivered psychoeducation to see if the Brief-Unified Protocol is effective for preventing posttraumatic stress and other psychological health symptoms. conditions: PTSD conditions: Alcohol Use Disorder conditions: Depression conditions: Anxiety studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 480 type: ESTIMATED name: Brief Unified Protocol name: Psychoeducation measure: PTSD Symptoms measure: Alcohol Use Disorder symptoms measure: Depression symptoms measure: Anxiety symptoms measure: Functional Impairment sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06290765 id: A23-401 briefTitle: Efficacy and Safety of Ropeginterferon Alfa 2b (P1101) for Patients With Low-Risk Polycythemia Vera acronym: PV overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2025-12-31 date: 2027-02-28 date: 2024-03-04 date: 2024-03-04 name: PharmaEssentia class: INDUSTRY briefSummary: This is a randomized, open-label, multicenter, two-arm study to assess the efficacy and safety of ropeginterferon alfa-2b for patients with low-risk PV. Approximately 110 patients with low-risk PV will be enrolled. The whole study period is 108 weeks, including a main treatment phase (56 weeks), an extension treatment phase (48 weeks), and a safety follow-up phase (four weeks). conditions: Polycythemia Vera conditions: Myeloproliferative Neoplasm studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 110 type: ESTIMATED name: Ropeginterferon alfa-2b name: Phlebotomy measure: The proportion of patients with treatment response evaluated. Treatment response is defined as the maintenance of the median HCT values <45% over time, without progression of disease, and no need of any extra-protocol cytoreductive drugs. sex: ALL minimumAge: 18 Years maximumAge: 59 Years stdAges: ADULT hasResults: False
<\|newrecord\|> nctId: NCT06290752 id: KY-2024-030 briefTitle: Determining the Learning Curve for Ultrasound-guided Caudal Epidural Block overallStatus: RECRUITING date: 2024-03-01 date: 2024-11-30 date: 2024-12-31 date: 2024-03-04 date: 2024-03-12 name: The Fourth Affiliated Hospital of Zhejiang University School of Medicine class: OTHER briefSummary: mastering ultrasound-guided sacral canal block entails traversing a multifaceted learning curve characterized by anatomical intricacies, technical challenges, and patient variability. Through systematic education, deliberate practice, and clinical experience, clinicians can ascend this learning curve and harness the full potential of this innovative technique in pain management. As the landscape of regional anesthesia continues to evolve, a commitment to ongoing learning and proficiency attainment is paramount for delivering safe, effective, and patient-centered care. conditions: Anesthesia studyType: OBSERVATIONAL observationalModel: ECOLOGIC_OR_COMMUNITY timePerspective: PROSPECTIVE count: 6 type: ESTIMATED measure: operation time sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Dongmei Ma status: RECRUITING city: Yiwu state: Zhejiang zip: 322000 country: China name: Zhu Xinqiang role: CONTACT phone: +8657989935052 lat: 29.31506 lon: 120.07676 hasResults: False
<\|newrecord\|> nctId: NCT06290739 id: JHuang886 briefTitle: A Machine-learning Model to Predict Lymph Node Metastasis of Intrahepatic Cholangiocarcinoma overallStatus: RECRUITING date: 2024-02-07 date: 2024-03-07 date: 2024-03-27 date: 2024-03-04 date: 2024-03-04 name: West China Hospital class: OTHER briefSummary: The object of this study is to develop a model for prediction of lymph node metastasis among intrahepatic cholangiocarcinoma (ICC) patients. Intrahepatic cholangiocarcinoma is the second most common kind of primary liver cancer, accounting for approximately 10%-15%. There is a lack of agreement regarding the necessity of performing lymph node dissection (LND) in patients with ICC. Currently, the percentage of LND is below 50%, and the rate of sufficient LND (≥6) has plummeted to less than 20%. Consequently, a large proportion of patients are unable to acquire LN status, which hinders the following systematic treatment strategies after surgery:. Therefore, our objective is to construct a LN metastasis model utilizing machine learning techniques, including patients' clinical data and pathology information, with the goal of offering a reference for patients who have not undergone LND or have had inadequate LND. conditions: Intrahepatic Cholangiocarcinoma conditions: Machine Learning studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 300 type: ESTIMATED name: lymph nodes dissection measure: Overall survival measure: Disease free survival sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Liver Surgery and Liver Transplantation Center, West China Hospital, Sichuan University status: RECRUITING city: Chengdu state: Sichuan zip: 610041 country: China name: fengmin Luo, Doctor role: CONTACT phone: +86 028-85582944 email: hxyyhfb@163.com lat: 30.66667 lon: 104.06667 hasResults: False
<\|newrecord\|> nctId: NCT06290726 id: 202001927B0 briefTitle: Long-term Outcomes of Living Donor Liver Transplantations With Anti-HBc (+) Grafts in Pediatric Patients overallStatus: COMPLETED date: 2002-02 date: 2016-02 date: 2024-01 date: 2024-03-04 date: 2024-03-05 name: Chang Gung Memorial Hospital class: OTHER briefSummary: The goal of this observational study is to compare in anti-HBc (+) grafts/ anti-HBc (-) grafts. The main question it aims to answer is the long-term efficacy of active vaccination and graft/patient outcomes of anti-HBc (+) grafts have yet to be comprehensively investigated. Researchers will compare anti-HBc (+) grafts/ anti-HBc (-) to see if it would affect the long-term survival. conditions: Living Donor Liver Transplantations With Anti-HBc (+) Grafts studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 204 type: ACTUAL measure: Long-term survival in pediatric recipients of living donor liver transplantations with anti-HBc (+) grafts sex: ALL minimumAge: 4 Months maximumAge: 18 Years stdAges: CHILD stdAges: ADULT hasResults: False
<\|newrecord\|> nctId: NCT06290713 id: IRB202301491 id: 1R21AR079755-01 type: NIH link: https://reporter.nih.gov/quickSearch/1R21AR079755-01 id: PRO00050023 type: OTHER domain: UFIRST briefTitle: Vasodilator and Exercise Study for DMD (VASO-REx) overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2026-11 date: 2026-11 date: 2024-03-04 date: 2024-03-21 name: University of Florida class: OTHER name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) briefSummary: Examining two strategies as potential adjuvant therapies for Duchenne muscular dystrophy (DMD); aerobic exercise training (to induce adaptations in skeletal muscle and improve cardiovascular health) and tadalafil, an FDA-approved vasodilator (to optimize blood flow and muscle perfusion which is impaired and often overlooked in DMD). Target: improved muscle function, vascular health, and DMD treatment. conditions: Duchenne Muscular Dystrophy conditions: Duchenne Disease conditions: Muscular Dystrophy conditions: Muscular Dystrophy in Children conditions: Vasodilation conditions: Exercise conditions: DMD studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants are assigned to receive interventions based on their completion and results of Aim 1 (responsiveness to study drug). If participants are found to be Tadalafil-responsive after one dose, they will be included in Aim 2 of the study and will be asked to participate in the double-blinded, randomized, placebo-controlled longitudinal medication \& exercise 6-month study program. primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 50 type: ESTIMATED name: Tadalafil name: Placebo name: Exercise Training measure: Vascular responsiveness after muscle contraction to a single dose of tadalafil. measure: Cycling time to fatigue measure: Quadriceps muscle Fat Fraction measure: Metabolic recovery measure: cardiopulmonary exercise testing (CPET) - Peak aerobic capacity (VO2max) measure: cardiopulmonary exercise testing (CPET) - Minute Ventilation (VE) measure: cardiopulmonary exercise testing (CPET) - Ventilatory Equivalent for Oxygen (VE/VO2) measure: cardiopulmonary exercise testing (CPET) - Gas Exchange Threshold (GET) measure: cardiopulmonary exercise testing (CPET) - Workload at Anaerobic Threshold (W at AT) measure: The 100-meter timed test (100m) measure: the North Star Ambulatory Assessment (NSAA) measure: The 4-stair climb measure: The Physical activity questionnaire (PAQ-C) measure: Pulmonary function testing - vital capacity (FVC) measure: Pulmonary function testing - forced expiratory volume in 1 second (FEV1) measure: Neurology Quality of Life (NeuroQoL) pediatric lower extremity function measure: Patient Reported Outcomes Measurement Information System (PROMIS) pediatric fatigue measure: PROMIS parent proxy for physical activity measure: PROMIS pediatric physical activity measure: Physical Activity Monitoring - Daily Step Rate measure: Physical Activity Monitoring - Time in Low-Level Activity measure: Physical Activity Monitoring - Time in Moderate-Level Activity measure: Physical Activity Monitoring - Time in High-Level Activity sex: MALE minimumAge: 6 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06290700 id: MCBU_2880 briefTitle: Effect of Neonatal Care Education for Primiparous Pregnant Women on Postpartum Maternal Function and Quality of Life overallStatus: COMPLETED date: 2022-11-01 date: 2024-02-01 date: 2024-02-01 date: 2024-03-04 date: 2024-03-04 name: Celal Bayar University class: OTHER briefSummary: This study aimed to evaluate the effect of neonatal care education for primiparous pregnant women on postpartum maternal function and quality of life. conditions: Life Quality conditions: Functional Status studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: PARTICIPANT count: 126 type: ACTUAL name: Neonatal Care education measure: severity of maternal function by Barkin Index of Maternal Functioning measure: Maternal Postpartum Quality of Life Instrument sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Yonca ÇIÇEK OKUYAN city: Manisa country: Turkey lat: 38.61202 lon: 27.42647 hasResults: False
<\|newrecord\|> nctId: NCT06290687 id: CASE5824 briefTitle: Partial Cystectomy & Extended Pelvic Lymph Node Dissection With SOC Perioperative Systemic Therapy overallStatus: NOT_YET_RECRUITING date: 2024-08 date: 2026-01-29 date: 2027-01-29 date: 2024-03-04 date: 2024-03-06 name: Case Comprehensive Cancer Center class: OTHER briefSummary: The goal of this clinical trial is to determine if a partial cystectomy with extended pelvic lymph node removal will be effective at treating Muscle-Invasive Bladder Cancer instead of a complete cystectomy with extended pelvic lymph node removal. This clinical trial aims to determine the safety and oncologic efficacy of the intervention, and to examine patient-reported quality of life outcomes in participants. Participants will receive the standard pre-surgery treatment for approximately 4 to 6 weeks. After the pre-surgery treatment is completed, participants will undergo a partial cystectomy with extended pelvic lymph node dissection. After surgery, participants will receive adjuvant systemic therapy. conditions: Malignant Neoplasm of Bladder conditions: Muscle Invasive Bladder Carcinoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is a single-center, prospective, phase II trial. primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: Neoadjuvant Chemotherapy name: Partial cystectomy with Extended pelvic lymph node dissection name: Adjuvant systemic therapy measure: Recurrence-Free Survival (RFS) measure: Presence of Post-operative Complications measure: Median Bladder RFS measure: Median Muscle-Invasive Bladder RFS measure: Median Bladder-Intact Survival measure: Median Cancer-Specific Survival measure: Changes in Genitourinary-specific HRQoL sex: ALL minimumAge: 19 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Glickman Urological and Kidney Institute, Cleveland Clinic, Case Comprehensive Cancer Center city: Cleveland state: Ohio zip: 44195 country: United States name: Nima Almassi, MD role: CONTACT phone: 216-444-1825 email: almassn2@ccf.org lat: 41.4995 lon: -81.69541 hasResults: False
<\|newrecord\|> nctId: NCT06290674 id: P.T.REC/012/004043 briefTitle: Extracorporeal Shockwave on Abdominal Adiposity and Lipid Profile overallStatus: COMPLETED date: 2022-09-11 date: 2024-01-01 date: 2024-02-01 date: 2024-03-04 date: 2024-03-07 name: Adly A Adam class: OTHER briefSummary: Almost postmenopausal women store significant extra visceral adipose tissue with unexplained mechanism, yet. Postmenopausal obese women with excess abdominal obesity have raised metabolic risk of numerous cardiovascular diseases, which negatively influence health policy concern. Therefore, actual need to recommend non-invasive approach that cover this lack of quantitative knowledge in clinical management of obese postmenopausal women. conditions: Obesity, Abdominal studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Clinical randomized controlled study primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Double masking (Investigator and Participant) whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 60 type: ACTUAL name: Extracorporeal Shockwave therapy name: Balanced low-calorie diet measure: Waist/ hip ratio measure: Skin fold caliper measure: Lipid profile sex: FEMALE minimumAge: 45 Years maximumAge: 60 Years stdAges: ADULT facility: Helwan General Hospital city: Cairo state: Helwan, Cairo Governate zip: 02 country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False
<\|newrecord\|> nctId: NCT06290661 id: UHCT-IEC-SOP-016-03-01 briefTitle: Clinical Trial of the Safety and Efficacy of Peripheral Nerve Stimulation in the Treatment of Postherpetic Neuralgia. overallStatus: RECRUITING date: 2023-02-09 date: 2024-12-31 date: 2025-06-30 date: 2024-03-04 date: 2024-03-04 name: Wuhan Union Hospital, China class: OTHER name: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine name: The Second People's Hospital of GuangDong Province name: Xiamen Hospital of Traditional Chinese Medicine briefSummary: The goal of this clinical trial is to evaluate safety and efficacy of percutaneous peripheral nerve stimulation in patients with postherpetic neuralgia. The main questions it aims to answer are:
1. The efficacy of percutaneous peripheral nerve stimulation in patients with postherpetic neuralgia
2. The safety of percutaneous peripheral nerve stimulation in patients with postherpetic neuralgia Participants are going to undergo procedure that implant peripheral nerve stimulation electrode produced by Jiangsu CED Medtech Co., Ltd. Then the subjects, whose VAS scores decrease more 30% than baseline level, are classified into two groups randomly. One of the group receiving active stimulation called trial group and another receiving placebo stimulation called control group. All subjects are required to make their own subjects' pain diary to record VSA score before and after implantation until at the end of follow-up. Also, participants are asked to report use of analgesic medications, number of awakenings and adverse events.
Researchers will compare pain scores between the two groups to see if peripheral nerve stimulation is effective to patients with postherpetic neuralgia. conditions: Neuropathic Pain conditions: Postherpetic Neuralgia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Active electrostimulation name: Placebo electrostimulation measure: Difference in mean pain visual analogue scale VAS scores between trial and control groups in the randomised withdrawal period measure: Visual simulation assessment scale collects pain scores after peripheral electrode placement measure: Proportion of subjects whose pain relief more than 30% measure: Proportion of subjects of ideal pain state measure: Sleep-related assessment after electrostimulation measure: Change of life quality after electrostimulation measure: Analgesic medications measure: Stability of external assistant devices measure: Questionnaire survey equipment satisfaction sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Union Hospital, Tongji medical college, Huazhong University of Science and Technology status: RECRUITING city: Wuhan state: Hubei zip: 430022 country: China name: Dong Yang, PHD role: CONTACT phone: 13871230491 phoneExt: 86 email: dongyang118@sina.com lat: 30.58333 lon: 114.26667 hasResults: False
<\|newrecord\|> nctId: NCT06290648 id: 22-0868 id: 5R34MH130555 type: NIH link: https://reporter.nih.gov/quickSearch/5R34MH130555 briefTitle: Forging New Paths: Building Interventions to Treat Criminogenic Needs in Community Based Mental Health Settings acronym: FNP overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-12 date: 2025-12 date: 2024-03-04 date: 2024-03-04 name: University of North Carolina, Chapel Hill class: OTHER name: National Institute of Mental Health (NIMH) briefSummary: The goal of this clinical trial is to conduct a preliminary test of the effectiveness of Forging New Paths for people with mental illness with criminal legal system contact. The main question\[s\] it aims to answer are:
1. To examine the effectiveness of Forging New Paths at improving the primary study outcomes (aggression and community tenure).
2. To test the ability of Forging New Paths to engage the study treatment targets (impulsivity and criminal attitudes)
Participants will complete a screening interviews to see if they are eligible. Participants who are eligible will be randomly assigned to participate in one of two study conditions: Forging New Paths and usual care or usual care alone. All participants who are assigned to a study condition will participate in up to three additional research interviews. Researchers will also collect information about study outcomes using administrative records. conditions: Mental Illness studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 72 type: ESTIMATED name: Forging New Paths measure: Change in Levels of Aggression Score from Baseline to Month 3 measure: Change in Levels of Aggression Score From Baseline to Month 6 measure: Community Tenure measure: Change in Overall Criminal Attitudes Score measure: Change in Overall Impulsivity Score sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of North Carolina at Chapel Hill city: Chapel Hill state: North Carolina zip: 27599 country: United States name: Amy Wilson, PhD role: CONTACT lat: 35.9132 lon: -79.05584 hasResults: False
<\|newrecord\|> nctId: NCT06290635 id: Pro00119668 briefTitle: Edmonton Dyspnea Inventory- Validation Study overallStatus: ACTIVE_NOT_RECRUITING date: 2022-11-11 date: 2024-05-30 date: 2024-12-30 date: 2024-03-04 date: 2024-04-11 name: University of Alberta class: OTHER briefSummary: Breathlessness is a common problem for many patients with Interstitial lung disease (ILD). ILD is a group of lung diseases that cause inflammation (swelling) and scarring in the lung tissue where gas exchange (oxygen and carbon dioxide) occurs. Unfortunately, there is no cure for these conditions and as a result many patients decline over time with worsening breathlessness. This limits their ability to live a good life. Clinicians do not often recognize, assess, or treat breathlessness appropriately. Breathlessness, being a subjective experience, cannot be fully understood through objective measurements such as lung function tests, the arterial blood gas test etc. The objective and subjective measures of breathlessness are frequently disconnected. Clinicians who often rely on these types of objective tests do not directly enquire into its nature and severity of breathlessness from patients themselves. As a result, they remain unaware of this disabling symptom and the extent of its impact on patients. While there are many tools to measure breathlessness, they are not consistently used in routine care or have impacted care in a meaningful way. Many such tools are also complex with intricate response systems with possibility of errors and user fatigue. As a result, easy to use tools like modified MRC or MRC are frequently used even though they do not assess severity of breathlessness. No tool has been effective at helping clinicians identify the problem and prescribe appropriate treatments. This results in needless suffering for patients and their families and prevents them from receiving timely and appropriate therapies. Investigators propose to test an easy-to-use tool that combines the subjective and objective aspects of breathlessness. Investigators hope that the tool will help clinicians quickly identify the patient's breathlessness severity and provide them with an algorithm of what to do next. The tool was developed by clinicians with +15 years of experience in ILD and dyspnea. Early analysis already suggests the tool is useful to patients and helps improve care. conditions: ILD studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: Breathlessness Assessment Tool measure: Validate Edmonton Dyspnea Inventory (EDI; formerly known as multidimensional dyspnea scale-MDDS) measure: To perform time-motion observation of care providers or patients using the scale measure: Calculate MCID for Edmonton Dyspnea Inventory measure: Feasibility of Questionnaire measure: To assess day-to-day variability in dyspnea scores sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Kaye Edmonton Clinic city: Edmonton state: Alberta zip: T6G 2G3 country: Canada lat: 53.55014 lon: -113.46871 facility: Aarhus University city: Aarhus country: Denmark lat: 56.15674 lon: 10.21076 facility: Bristol ILD Service; North Bristol NHS Trust city: Bristol country: United Kingdom lat: 51.45523 lon: -2.59665 hasResults: False
<\|newrecord\|> nctId: NCT06290622 id: IRB300012414 (UAB23136) briefTitle: PD-1, LAG-3 and TIM-3 Checkpoint Blockade in DLBCL overallStatus: NOT_YET_RECRUITING date: 2024-06-30 date: 2026-06-30 date: 2028-01-31 date: 2024-03-04 date: 2024-04-24 name: University of Alabama at Birmingham class: OTHER briefSummary: This study is investigating the optimal dose and the advantage in combining investigational immunotherapy drugs known as Retifanlimab, INCAGN02385 and INCAGN02390 to improve the responses to CAR T-cell therapy. Additionally, the study will investigate that triple checkpoint blockade of PD-1, TIM-3 and LAG-3 molecules will overcome CAR T-cell therapy resistance in patients with suboptimal responses. conditions: Diffuse Large B Cell Lymphoma conditions: Lymphoma, B-Cell conditions: Lymphoma, Follicular studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 18 type: ESTIMATED name: Retifanlimab, INCAGN02385, INCAGN02390 measure: Identify the optimal biological dose (OBD) for Retifanlimab in combination with INCAGN02385 and INCAGN02390 in relapsed/refractory DLBCL. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Alabama at Birmingham city: Birmingham state: Alabama zip: 35294 country: United States name: Margaret Thomas role: CONTACT email: margaretannthomas@uabmc.edu name: Mayur Narkhede, MD role: PRINCIPAL_INVESTIGATOR name: Amitkumar Mehta, MD role: SUB_INVESTIGATOR name: Lauren Shea, MD role: SUB_INVESTIGATOR name: Gaurav Goyal, MD role: SUB_INVESTIGATOR lat: 33.52066 lon: -86.80249 hasResults: False
<\|newrecord\|> nctId: NCT06290609 id: 72799 briefTitle: Vibrotactile Coordinated Reset for Spasticity After Spinal Cord Injury overallStatus: NOT_YET_RECRUITING date: 2024-03-15 date: 2024-06-15 date: 2024-06-15 date: 2024-03-04 date: 2024-03-04 name: Stanford University class: OTHER briefSummary: The purpose of our study is to evaluate vibrotactile Coordinated Reset (vCR) and its effects on spasticity symptoms in incomplete spinal cord injured patients. vCR will be administered with a device called the Stanford CR Glove. vCR is expected to provide patients with a non-invasive alternative to the most widely used treatments such as oral baclofen and or deep brain stimulation. Patients will be followed for three months and will be asked to come to the lab for clinical testing 4 times during this period. A total of 30 patients will be included in the study. conditions: Spasticity, Muscle conditions: Spinal Cord Injuries studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: A single group of participants who will receive active treatment with the experimental stimulation device will be studied. primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Vibrotactile Coordinated Reset measure: Change from baseline in spasticity with the Modified Ashworth Scale (MAS) at 2 hours, 1 week, 4 weeks, and 12 weeks. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Stanford University city: Stanford state: California zip: 94305 country: United States name: Peter Tass, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 37.42411 lon: -122.16608 hasResults: False
<\|newrecord\|> nctId: NCT06290596 id: MSR/AZAST/AIP029/21/222/8/2023 briefTitle: Vasopressin Versus Tranexamic Acid for Control of Blood Loss Related to Abdominal Hysterectomy overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-10-01 date: 2024-10-01 date: 2024-03-04 date: 2024-03-06 name: Al-Azhar University class: OTHER briefSummary: To find the best option to reduce blood loss related to abdominal hysterectomy (AH), the present randomized double-blinded study sought to compare the effects of locally administered vasopressin (VP) and tranexamic acid (TXA) on blood loss in women submitted to AH for benign lesions. conditions: Uterine Surgery studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 387 type: ESTIMATED name: Vasopressin name: Tranexamic acid name: Saline measure: blood loss sex: FEMALE minimumAge: 20 Years maximumAge: 60 Years stdAges: ADULT hasResults: False
<\|newrecord\|> nctId: NCT06290583 id: Prilocaine in cesarean section briefTitle: Comparing the Effect of Spinal Bupivacaine Versus Spinal Prilocaine on Maternal Blood Pressure in Cesarean Section overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2024-11 date: 2024-12 date: 2024-03-04 date: 2024-03-05 name: South Valley University class: OTHER briefSummary: one of the most common complications associated with spinal anesthesia is hypotension, which can have adverse effects on both the mother and the fetus. The present study compare prilocaine versus bupivacaine in spinal anesthesia on hypotension and there effect on maternal outcomes. conditions: Spinal Anesthetics Causing Adverse Effects in Therapeutic Use studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Bupivacaine name: Prilocaine measure: Maternal arterial blood pressure measure: Evaluation of duration of motor block measure: Total dose of ephedrine sex: FEMALE minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT hasResults: False
<\|newrecord\|> nctId: NCT06290570 id: 23-007685 briefTitle: A Study of Artificial Intelligence ECG With ECG Devices to Detect Hypertrophic Cardiomyopathy Distinct From Athlete's Heart overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-09 date: 2025-09 date: 2024-03-04 date: 2024-04-03 name: Mayo Clinic class: OTHER briefSummary: The purpose of this study is to evaluate the AI-ECG algorithm for HCM in detecting HCM and in differentiating it from athlete's heart using not only the standard 12-lead ECG, but also ECGs obtained with the Apple Watch and Alivecor KardiaMobile devices. conditions: Hypertrophic Cardiomyopathy conditions: Athlete Heart studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 300 type: ESTIMATED name: 12-Lead ECG name: Apple Smart Watch Single Lead ECG name: AliveCor KardiaMobile 6-Lead ECG measure: Distribution of AI-ECG probabilities in HCM measure: Comparative diagnostic performance between tracings obtained from different devices measure: Distribution of AI-ECG probabilities in Athlete's Heart measure: Correlation with false negative AI ECG result sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mayo Clinic in Rochester city: Rochester state: Minnesota zip: 55905 country: United States name: Heart Rhythm Services Research Team role: CONTACT phone: 507-255-0774 name: Konstantinos Siontis, MD role: CONTACT phone: (507) 255-1051 email: Siontis.Konstantinos@mayo.edu name: Konstantinos Siontis, MD role: PRINCIPAL_INVESTIGATOR lat: 44.02163 lon: -92.4699 hasResults: False
<\|newrecord\|> nctId: NCT06290557 id: 2023-507737-17-00 briefTitle: First-in-man Single-dose and Multiple Dose Study to Evaluate the Safety, Tolerability and Efficacy ofHY-133 acronym: HY-133 overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2025-07-01 date: 2026-07-01 date: 2024-03-04 date: 2024-03-05 name: University Hospital Tuebingen class: OTHER briefSummary: In this clinical trial we will test a new approach for decolonization of S. aureus.
As innovative product HY-133 a recombinant chimeric bacteriophage endolysin will be sprayed in both nostrils of healthy subjects once or five times in one day. To avoid possible bias the subjects will be randomized 3:2 verum vs placebo, moreover the subject as well as the investigator will be blinded to the group assigned. conditions: Staphylococcus Aureus studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 52 type: ESTIMATED name: HY_133 name: Placebo measure: ADRs/AEs/SAEs occurring from the time of application until the final study visit (Day15) for each subject sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06290544 id: CCM 1552 briefTitle: Cardiovascular Risk Assessment in a Cohort of Italian Patients With Type 1 Diabetes Mellitus (CARDT1) acronym: CARDT1 overallStatus: RECRUITING date: 2021-11-29 date: 2026-07 date: 2026-07 date: 2024-03-04 date: 2024-03-04 name: Centro Cardiologico Monzino class: OTHER briefSummary: This is a multicenter prospective collection of data with diagnostic procedures different from standard clinical care in a specific cohort of patients, aimed to evaluate cardiovascular risk stratification with the European Society of Cardiology (ESC)/European Association for the Study of Diabetes (EASD) guidelines and "The Steno Type 1 Risk Engine" algorithm. The correlation between CVD risk, atherosclerosis, and microvascular complications of diabetes (retinopathy, nephropathy, and neuropathy) will then be evaluated, and the impact of glycemic variability and other glucose metrics on vascular damage will be characterized. The investigators plan to enroll at least 200 consecutive type 1 diabetes mellitus (T1DM) patients who meet all the inclusion criteria and none of exclusion criteria. conditions: Diabetes Mellitus, Type 1 conditions: Cardiovascular Diseases studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Prospective collection of data with diagnostic procedures different from standard clinical care in a specific cohort of patients. primaryPurpose: PREVENTION masking: NONE count: 200 type: ESTIMATED name: Standard of care plus additional examinations measure: Stratify cohort of type 1 diabetes patient according to ESC/EASD 2019 guidelines. measure: Stratify cohort of type 1 diabetes patient according to the Steno Type 1 Risk Engine (ST1RE). measure: Prevalence of cardiovascular disease in type 1 diabetes patients measure: Prevalence of diabetic retinopathy measure: Prevalence of diabetic nephropathy measure: Prevalence of diabetic neuropathy measure: CT-derived calcium score measure: Carotid intima-media thickness measure: Prevalence of endothelial dysfuntion (evaluated using peripheral arterial tone detection method) measure: Stratify type 1 patient cohort by Food Frequency Questionnaire (FFQ) measure: Stratify type 1 patient cohort by the Mediterranean Diet Adherence Screener score (MEDAS) measure: Stratify type 1 patient cohort by psychological profiles using psychological validated questionnaires. measure: Stratify type 1 patient cohort by lipid profile measure: Stratify type 1 patient by glucose control using HbA1c and Ambulatory Glucose Profile metrics. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Centro Cardiologico Monzino status: RECRUITING city: Milan zip: 20138 country: Italy name: Stefano Genovese, MD role: CONTACT phone: 0258002327 email: stefano.genovese@cardiologicomonzino.it lat: 45.46427 lon: 9.18951 facility: Policlinico di Monza status: NOT_YET_RECRUITING city: Monza zip: 20900 country: Italy name: Gianluca Perseghin, MD role: CONTACT phone: +390392810430 email: gianluca.perseghin@policlinicodimonza.it lat: 45.58005 lon: 9.27246 hasResults: False
<\|newrecord\|> nctId: NCT06290531 id: CEBD-CU-2023-11-12 briefTitle: Different Methods for Reducing Buccal Infiltration Local Anesthesia Injection Pain overallStatus: COMPLETED date: 2022-01-16 date: 2023-09-28 date: 2023-09-28 date: 2024-03-04 date: 2024-03-04 name: Cairo University class: OTHER briefSummary: Local anesthetic injection is considered one of the most annoying dental procedures. The use of topical anesthesia is considered a routine procedure in the dental clinic especially for children. However, the taste and application procedure of the topical gel may not be pleasant for all children.
The introduction of the Buzzy device is considered a distraction measure in the medical field. Alanazi et al., 2019, studied the effect of using the Buzzy device with cold and vibration compared to the conventional infiltration technique using 30-gauge needle. They concluded that the use of the Buzzy device resulted in better patients' acceptance and significantly lower Wong-Baker scores.
Ballard et al., 2019, mentioned in their systematic review the efficacy of the Buzzy device for pain management during needle-related procedures, they concluded that the use of the device may be promising. Ghaderi et al., 2013, evaluated the effect of cooling the injection site on pain perception before infiltration of local anesthetics. They found that cooling the injection site before infiltration of local anesthetics in the buccal mucosa for 1 min, reduced pain perceived by pediatric patients. conditions: Dental Caries in Children studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE maskingDescription: The statistician was only blinded for data analysis. But it was not feasible to blind the participant, investigator or the outcome assessor due to the nature of the study. count: 96 type: ACTUAL name: Buzzy device (cold and vibration) name: Buzzy device (vibration only) name: precooling name: Flavored Benzocaine topical anesthetic gel 20% measure: Patient reported pain during needle injection measure: Child behaviour during needle injection measure: Heart rate measure: Oxygen saturation measure: Child and parent satisfaction sex: ALL minimumAge: 6 Years maximumAge: 12 Years stdAges: CHILD facility: Pediatric Dentistry and Dental Public Health, Faculty of Dentistry, Cairo University city: Cairo zip: 11559 country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False
<\|newrecord\|> nctId: NCT06290518 id: PROBIFERT P051 briefTitle: Modulation of Reproductive Microbiota by Ligilactobacillus Salivarius CECT5713 overallStatus: COMPLETED date: 2020-09-01 date: 2023-05-03 date: 2024-01-29 date: 2024-03-04 date: 2024-03-04 name: Biosearch S.A. class: INDUSTRY name: Hospital San Carlos, Madrid name: Universidad Complutense de Madrid briefSummary: The objective of the project is to elucidate if the oral administration of Ligilactobacillus salivarius CECT5713 is capable of improving the rates of term pregnancies in couples with infertility problems of unknown cause. On the other hand, the project is aimed to detect microbiological, immunological and hormonal markers that allow the identification of couples in which the administration of the strain could be particularly effective. This is a randomized, double-blind, parallel-group controlled nutritional intervention study. The intervention (Ligilactobacillus salivarius CECT5713 or placebo) will be performed during the 6 months prior to the fertility treatment and during the first IVF cycle (estimated 1-2 months). In case of pregnancy, the woman will continue the treatment until 12 weeks of gestation. conditions: Infertility Unexplained studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Parallel Assignment Volunteers are classified into 2 groups. All women in the probiotic group consume (oral route) a daily capsule with \~50 mg of freeze-dried probiotic (9.5 log10 CFU of L. salivarius CECT5713; excipient: maltodextrin). All women in the placebo group consume (oral route) a daily capsule with \~50 mg of maltodextrin. primaryPurpose: BASIC_SCIENCE masking: TRIPLE maskingDescription: Triple (Participant, Care Provider, Investigator) Only one person of the collaborator that provides the capsules (Biosearch Life) know the correspondecs between each reference (one reference per each subject) and the arm (probiotic or placebo). The codes are blinded for the participant, the care provider and the investigator. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 72 type: ACTUAL name: Ligilactobacillus salivarius CECT5713 name: Placebo measure: Successful pregnancies measure: Modification of the vaginal microbiota measure: Vaginal immunomodulation sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Biosearch S.A.U. city: Granada zip: 18004 country: Spain lat: 37.18817 lon: -3.60667 facility: Hospital Clínico San Carlos city: Madrid zip: 28040 country: Spain lat: 40.4165 lon: -3.70256 facility: Universidad Complutense de Madrid city: Madrid zip: 28040 country: Spain lat: 40.4165 lon: -3.70256 hasResults: False
<\|newrecord\|> nctId: NCT06290505 id: PALEO briefTitle: A Trial of Palliative Chemotherapy, Radiation and Immune Treatment for Oesophageal Cancer: PALEO Study acronym: PALEO overallStatus: RECRUITING date: 2021-12-08 date: 2027-07-31 date: 2028-01-31 date: 2024-03-04 date: 2024-03-04 name: Australasian Gastro-Intestinal Trials Group class: NETWORK briefSummary: The purpose of this study is to investigate the effects of the addition of the stereotactic body radiotherapy and durvalumab to a well tolerated 2 week chemotherapy and radiation treatment regimen in people with oesophageal cancer that has spread to another are of the body (metastasised). conditions: Oesophageal Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 54 type: ESTIMATED name: Durvalumab measure: Progression free survival rate is the proportion of patients alive and progression free (the cancer has not worsened) assessed by CT Scan and clinical review. measure: Duration of dysphagia relief measure: Nutritional status measure: Quality of life change using the - European organisation for the research and treatment of cancer quality of life questionnaire QLQ-C30 measure: Quality of life change using the - European organisation for the research and treatment of cancer quality of life questionnaire QLQ-OES18 measure: Response rate in metastatic lesions measure: Physician graded toxicity measure: SAE Rate measure: Overall survival. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Border Medical Oncology status: RECRUITING city: Albury state: New South Wales zip: 2640 country: Australia name: Jacqui McBurnie role: CONTACT email: jacqui.mcburnie@bordermedonc.com.au lat: -36.07482 lon: 146.92401 facility: Calvary Mater Newcastle status: RECRUITING city: Newcastle state: New South Wales zip: 2298 country: Australia name: Kim Adler role: CONTACT email: paleo@calvarymater.org.au lat: -32.92715 lon: 151.77647 facility: Royal Brisbane and Women's Hospital status: RECRUITING city: Herston state: Queensland zip: 4029 country: Australia name: Jacqui Keller role: CONTACT email: jacqui.keller@health.qld.gov.au lat: -27.44453 lon: 153.01852 facility: Flinders Medical Centre status: RECRUITING city: Bedford Park state: South Australia country: Australia name: Aleksandra Kuruni, Dr role: CONTACT email: Aleksandra.Kuruni@sa.gov.au lat: -35.03333 lon: 138.56667 facility: St Vincent's Hospital status: RECRUITING city: Fitzroy state: Victoria zip: 3065 country: Australia name: Nadia Ranieri role: CONTACT email: Nadia.RANIERI@svha.org.au lat: -37.79839 lon: 144.97833 facility: Peter MacCallum Cancer Centre status: RECRUITING city: Melbourne state: Victoria zip: 3000 country: Australia name: Shandelle Norman role: CONTACT email: Shandelle.Norman@ctaust.org lat: -37.814 lon: 144.96332 facility: Sir Charles Gairdner Hospital status: RECRUITING city: Nedlands state: Western Australia zip: 6009 country: Australia name: Aylin Yahya role: CONTACT email: Aylin.Yahya@health.wa.gov.au lat: -31.98184 lon: 115.8073 facility: Auckland Hospital status: RECRUITING city: Grafton state: Auckland zip: 1023 country: New Zealand name: Sophie Goodger role: CONTACT email: SophieGo@adhb.govt.nz lat: -36.86029 lon: 174.76566 hasResults: False
<\|newrecord\|> nctId: NCT06290492 id: AHMU-tDCS-insomnia briefTitle: Clinical Efficacy and Mechanism of High Definition tDCS Based on dmPFC in the Intervention of Chronic Insomnia overallStatus: RECRUITING date: 2023-05-01 date: 2023-12-30 date: 2024-11-01 date: 2024-03-04 date: 2024-03-04 name: WANG KAI class: OTHER briefSummary: To investigate the intervention effect of transcranial direct current stimulation (tDCS) on subjective and objective insomnia symptoms and daytime function of chronic insomnia patients. conditions: Chronic Insomnia conditions: Transcranial Direct Current Stimulation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 45 type: ESTIMATED name: transcranial direct current stimulation name: sham transcranial direct current stimulation measure: subjective sleep quality assessed by the PSQI measure: subjective sleep quality assessed by the ISI measure: daytime sleepiness assessed by the FFS measure: daytime sleepiness assessed by the ESS measure: objective sleep quality assessed by the PSG measure: emotional symptoms assessed by the HAMA measure: emotional symptoms assessed by the HAMD sex: ALL minimumAge: 15 Years maximumAge: 65 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Anhui Medical University status: RECRUITING city: Hefei state: Anhui country: China name: Kai Wang, PhD role: CONTACT phone: +86-0551-62923704 email: wangkai1964@126.com name: Chengjuan Xie role: CONTACT phone: +8615656989777 email: xie_chengjuan@126.com lat: 31.86389 lon: 117.28083 hasResults: False
<\|newrecord\|> nctId: NCT06290479 id: 20358 briefTitle: A Three-Group Study to Examine the Efficacy of the Air up® Drinking System at Improving Hydration and Associated Health Outcomes overallStatus: RECRUITING date: 2024-02-15 date: 2024-06-30 date: 2024-06-30 date: 2024-03-04 date: 2024-03-04 name: air up GmbH class: INDUSTRY name: Citruslabs briefSummary: A randomized, controlled trial evaluating the air up® drinking system's impact on hydration and health outcomes. Participants will use air up® with Peach, Orangeade, or unscented pods and their effects on drinking habits, and health outcomes will be assessed over 12 weeks. conditions: Water Intake studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Care Provider, Investigator) primaryPurpose: OTHER masking: QUADRUPLE maskingDescription: Masking: Triple (Participant, Care Provider, Investigator) whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 50 type: ESTIMATED name: Air Up® Peach Pod name: Air Up® Orangeade Pod measure: Change in Hydration Habits and Health Outcomes as Measured by the Water Intake Questionnaire and the Hydration-Related Quality of Life Scale measure: Blood Biomarkers sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Citruslabs status: RECRUITING city: Santa Monica state: California zip: 90404 country: United States name: Patrick Renner, MSc role: CONTACT email: hello@citruslabs.com lat: 34.01945 lon: -118.49119 hasResults: False
<\|newrecord\|> nctId: NCT06290466 id: FCN-437c-CP-004 briefTitle: Clinical Study on Pharmacokinetics of FCN-437c Capsule and Its Effect on QT Interval in Healthy Subjects overallStatus: COMPLETED date: 2022-11-11 date: 2023-02-08 date: 2023-02-08 date: 2024-03-04 date: 2024-03-04 name: Ahon Pharmaceutical Co., Ltd. class: OTHER briefSummary: This is a single-center, randomized, double-blind, placebo-controlled Phase I clinical trial in healthy subjects.In healthy subjects, 300mg and 400mg FCN-437c capsules were taken orally for a single time. C-QTc effect model was used to evaluate the influence of blood concentration on QT interval, and the pharmacokinetic characteristics and safety of FCN-437c were also evaluated.Based on the C-QTc effect model, this study quantitatively analyzed the relationship between ΔΔQTcF and blood concentration, and evaluated the upper limit of 90% bilateral confidence interval of ΔΔQTcF corresponding to the geometric mean of Cmax at clinically relevant dose of FCN-437c capsule.
This study plans to set up 2 dose groups, low-dose group 300mg and high-dose group 400mg.Nine healthy subjects were planned to be enrolled in each dose group, with a 2:1 ratio of placebo control.
This study was carried out in the order of dose from low to high. After the administration of the low-dose group (300mg) and the safety assessment on the fourth day after administration, the study of the high-dose group (400mg) was decided through comprehensive evaluation. conditions: Advanced Breast Cancer studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 18 type: ACTUAL name: Low dose group name: High dose group measure: ΔΔQTcF measure: adverse events measure: Physical examination measure: Axillary temperature measure: blood pressure measure: pulse measure: Ecg monitoring and electrocardiogram measure: laboratory examination measure: Plasma concentration and pharmacokinetic parameters measure: Plasma concentration and pharmacokinetic parameters measure: Plasma concentration and pharmacokinetic parameters measure: Plasma concentration and pharmacokinetic parameters measure: Plasma concentration and pharmacokinetic parameters measure: Plasma concentration and pharmacokinetic parameters measure: Plasma concentration and pharmacokinetic parameters measure: Plasma concentration and pharmacokinetic parameters measure: Plasma concentration and pharmacokinetic parameters sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Peking University Third Hospital city: Beijing state: Beijing zip: 100191 country: China lat: 39.9075 lon: 116.39723 hasResults: False
<\|newrecord\|> nctId: NCT06290453 id: AOGR briefTitle: The Regulatory Role of miRNA 27 Follistatin Like Protein-1 Gene in Multiple Scelerosis overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-03 date: 2026-03 date: 2024-03-04 date: 2024-03-04 name: Assiut University class: OTHER briefSummary: Multiple sclerosis (MS) is a neurodegenerative disease characterized by demyelination of the central nervous system. Young women between the ages of 20 and 40 are primarily targeted by this disabling disorder. Till now there are no sufficient mechanisms to explain the pathophysiology of multiple sclerosis. conditions: Multiple Sclerosis studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 60 type: ESTIMATED name: micro RNA 27- FLP1 gene expression name: The Expanded Disability Status Scale (EDSS) name: Electrophysiological assessment: name: MRI examination MRI brain: measure: • To measure the levels of miR-27 expression and its target gene (FSTL1) in progressive MS and relapsing-remitting multiple sclerosis (RRMS) patients. measure: To correlate the levels of expression of miR-27 expression and its target gene (FSTL1) relative to the severity of symptoms of MD patients. sex: FEMALE minimumAge: 20 Years maximumAge: 45 Years stdAges: ADULT hasResults: False
<\|newrecord\|> nctId: NCT06290440 id: 28/NDGD-HDDD briefTitle: MEdication Counselling Models for Outpatient oRal antIcoaguLation acronym: MEMORIAL overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2025-12 date: 2026-12 date: 2024-03-04 date: 2024-03-06 name: Gia Dinh People Hospital class: OTHER briefSummary: The goal of this clinical trial is to investigate whether telepharmacy-led counselling can improve medication adherence, knowledge, and hospitalisation/mortality compared with pharmacist-led counselling in adult outpatients taking oral anticoagulants. conditions: Anticoagulants; Circulating, Hemorrhagic Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 360 type: ESTIMATED name: Telepharmacy-led counselling name: Pharmacist-led counselling measure: Medication adherence measure: Knowledge of oral anticoagulants measure: All-cause hospitalisation measure: VTE-related hospitalisation measure: Bleeding-related hospitalisation measure: All-cause mortality measure: VTE-related mortality measure: Bleeding-related mortality sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06290427 id: COMPAR-K briefTitle: Comparison of Outcomes of Multiple Platforms for Assisted Robotic-Kidney (COMPAR-K) acronym: COMPAR-K overallStatus: RECRUITING date: 2024-02-01 date: 2024-06 date: 2024-12 date: 2024-03-04 date: 2024-03-04 name: Azienda Ospedaliera Universitaria Integrata Verona class: OTHER briefSummary: The Urology Unit of AOUI Verona proposes a clinical study aimed at a preliminary evaluation of postoperative complications specifically focused on robotic partial nephrectomy (RAPN) procedures using three currently available platforms:
* DaVinci®;
* Hugo®;
* Versius®.
The questions it aims to answer are:
Does the estimation of the post-operative complications suggest something? Are differences (intra- and post-operative, oncological, functional, technical, and economic) among the three intervention approaches observable?
Participants will be invited to join one of these three experimental group:
1. surgery with the DaVinci platform;
2. surgery with the Hugo platform;
3. surgery with the Versius platform. conditions: Renal Carcinoma studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 45 type: ESTIMATED name: DaVinci RAPN name: Hugo RAS RAPN name: Versius® RAPN measure: Number of participants with postoperative complications measure: Number of participants with moderate to major postoperative complications measure: Number of participants with major postoperative complications measure: Overall duration of the surgery measure: Number of intraoperative complications measure: Type of intraoperative complications measure: Number of intraoperative technical malfunctions measure: Type of intraoperative technical malfunctions measure: Estimated Blood Loss measure: Postoperative hospitalization measure: Postoperative pain measure: Positive Surgical Margins measure: Serum Creatinine dosage for renal function assessment measure: Estimated Glomerular Filtration Rate for renal function assessment measure: Time taken for platform related timings measure: Procedure-related costs sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Urology Unit, AOUI Verona status: RECRUITING city: Verona state: VR zip: 37126 country: Italy name: Alessandro AA Antonelli, MD role: CONTACT phone: +39 0458127701 email: alessandro.antonelli@aovr.veneto.it name: Unità Ricerca Clinica role: CONTACT phone: +39 0458122844 email: unita.ricerca.clinica@aovr.veneto.it lat: 45.4299 lon: 10.98444 hasResults: False
<\|newrecord\|> nctId: NCT06290414 id: FDASU-Rec IM 112318 briefTitle: The Accuracy of Infrared Thermographic Imaging for Assessment of Periodontal Status overallStatus: RECRUITING date: 2023-11-30 date: 2024-03-30 date: 2024-07-30 date: 2024-03-04 date: 2024-03-04 name: Ain Shams University class: OTHER briefSummary: The diagnosis and differentiation between periodontal diseases are currently based on the measuring and interpretation of full-mouth clinical and radiographic criteria. Thermography is a modern non-invasive imaging method in which the infrared radiation emitted by an object allows the mapping and analysis of the exact temperature distribution on the surface of the object. The produced thermal images correlate with variations in local blood supply and tissue metabolism. Thus, suggested to be a useful rapid and non-invasive tool for the diagnosis of periodontal diseases. However, the validity of this tool compared to standard tools should be evaluated. conditions: Periodontal Diseases studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 45 type: ESTIMATED name: infrared thermal camera measure: Determine the agreement of thermographic images for diagnosis of periodontal diseases measure: The temperature ranges for healthy periodontium, gingivitis and periodontitis sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Faculty of dentistry Ain Shams University status: RECRUITING city: Cairo country: Egypt name: Shrouk N. Elboray, BDS role: CONTACT phone: +201065433857 email: shrouk.elboraay@dent.asu.edu.eg name: Mahetab M. AbdalWahab, lecturer role: CONTACT phone: +201115554490 email: mahetabmohamed@dent.asu.edu.eg name: Ola M. Ezzatt, professor role: PRINCIPAL_INVESTIGATOR lat: 30.06263 lon: 31.24967 hasResults: False
<\|newrecord\|> nctId: NCT06290401 id: 2023-0671 briefTitle: A Socio-ecological Approach for Improving Self-management in Adolescents With SCD acronym: SC-Thrive overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2028-01-31 date: 2028-06-30 date: 2024-03-04 date: 2024-03-04 name: Children's Hospital Medical Center, Cincinnati class: OTHER name: Nemours Children's Health System name: Emory University name: Children's Hospital of Philadelphia briefSummary: The goal of this clinical trial is to evaluate the impact of SCThrive (a behavioral self-management intervention) on patient activation, self-management behaviors, daily functioning, and emergency room visits in 260 adolescents and young adults with sickle cell disease (SCD) ages 13-21 receiving care at 1 of 4 pediatric SCD clinics.
The main question\[s\]it aims to answer are:
* Does SCThrive improve patient activation?
* Does SCThrive improve self-management behaviors, daily functioning, and decrease emergency room visits?
* Are any improvements maintained 3 months after treatment?

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