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## A Study to Compare the Pharmacokinetics and the Safety Between a Fixed-dose Combination Administration of "BR3005" and Co-administration of "BR3005-1" and "BR3005-2" Under Fed Conditions in Healthy Adult Volunteers - NCT ID: NCT06289933 - Study ID: BR-EMC-CT-103 - Status: RECRUITING - Start Date: 2024-03 - Completion Date: 2024-03 - Lead Sponsor: Boryung Pharmaceutical Co., Ltd ### Study Description The objective of this clinical study is to compare the pharmacokinetics and the safety between a fixed-dose combination administration of "BR3005" and co-administration of "BR3005-1" and "BR3005-2" under fed conditions in healthy adult volunteers ### Conditions - Type2 Diabetes Mellitus ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - BR3005 - BR3005-1 - BR3005-2 ### Outcomes Primary Outcomes - AUCτ - Cmax Secondary Outcomes ### Location - Facility: Clinical Research Center, H PLUS Yangji Hospital, Seoul, Gwanakgu, 08779, Korea, Republic of @@
## A Study to Compare the Pharmacokinetics and the Safety Between a Fixed-dose Combination Administration of "BR3005" and Co-administration of "BR3005-1" and "BR3005-2" Under Fasting Conditions in Healthy Adult Volunteers - NCT ID: NCT06289920 - Study ID: BR-EMC-CT-102 - Status: RECRUITING - Start Date: 2024-03 - Completion Date: 2024-03 - Lead Sponsor: Boryung Pharmaceutical Co., Ltd ### Study Description The objective of this clinical study is to compare the pharmacokinetics and the safety between a fixed-dose combination administration of "BR3005" and co-administration of "BR3005-1" and "BR3005-2" under fasting conditions in healthy adult volunteers ### Conditions - Type 2 Diabetes Mellitus ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - BR3005 - BR3005-1 - BR3005-2 ### Outcomes Primary Outcomes - AUCτ - Cmax Secondary Outcomes ### Location - Facility: Clinical Research Center, H PLUS Yangji Hospital, Seoul, Gwanakgu, 08779, Korea, Republic of @@
## Hot Flash and Night Sweat Virtual Study - NCT ID: NCT06289907 - Study ID: LH-BH-ADV-01 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-07-09 - Completion Date: 2024-07-30 - Lead Sponsor: Bonafide Health ### Study Description The purpose of this research study is to evaluate the effectiveness of the study product on vasomotor symptoms (VMS) and overall menopause symptoms in healthy women, who are perimenopausal or postmenopausal, and aged 40 - 65. ### Conditions - Menopause ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Bonafide-HF3.0 - Placebo ### Outcomes Primary Outcomes - To determine the effects of the Study Product (SP) compared to placebo on hot flash symptoms - To determine the effects of the SP compared to placebo on hot flash symptoms - To determine the effects of the SP compared to placebo on hot flash symptoms - To determine the effects of the SP compared to placebo on vasomotor symptoms - To determine the effects of the SP compared to placebo on overall menopausal symptoms - To determine the effects of the SP compared to placebo on overall menopausal symptoms - To determine the effects of the SP compared to placebo on quality of life Secondary Outcomes ### Location - Facility: Lindus Health, Inc., London, N/A, N/A, United Kingdom @@
## A Study of BRY805 in Participants With Advanced Solid Tumors - NCT ID: NCT06289894 - Study ID: BRY805-101 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2027-09 - Lead Sponsor: BioRay Pharmaceutical Co., Ltd. ### Study Description This is a phase 1 open label multicenter study to evaluate safety, tolerance and the maximum tolerance of BRY805 administered intravenously (IV) once every three weeks in participants with advanced solid tumors, so as to confirm the recommended phase 2 dose of BRY805 and obtain the preliminary efficacy information of participants with advanced solid tumors. ### Conditions - Advanced Solid Tumor ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - BRY805 injection ### Outcomes Primary Outcomes - Occurrence of Drug Limited Toxicities (DLTs) - Type and incidence of Treatment-emergent adverse event (TEAEs) and serious adverse events (SAEs) Secondary Outcomes - BRY805 Serum Concentrations - Number of Participants with BRY805 Antibodies - Overall Response Rate (ORR) - Disease Control Rate (DCR) - Progression-Free Survival (PFS) ### Location - Facility: Shandong Tumor hospital, Jinan, Shandong, 250117, China @@
## Sildenafil 100 mg Tablets Relative to Viagra 100 mg Tablets - NCT ID: NCT06289881 - Study ID: SIL-026-21 - Status: NOT_YET_RECRUITING - Start Date: 2025-02-04 - Completion Date: 2025-03-25 - Lead Sponsor: Bio-innova Co., Ltd ### Study Description The study is to compare the rate and extent of absorption of a generic formulation with that of a reference for mulation when given as equal labeled dose. The study will be randomized, open-label, single dose, two way crossover design with two-period, two-treatment and two-sequence under fasting condition and at least 3 days washout period between the doses. ### Conditions - Healthy Subjects ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: BASIC_SCIENCE ### Interventions - Sildenafill-Test product - Sildenafill-Reference product ### Outcomes Primary Outcomes - Area under the plasma concentration-time curve from time zero to the last measurable concentration (AUC 0-t) - Maximal measured plasma concentration (Cmax) Secondary Outcomes - Number of subjects with adverse events ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Access Anti-HAV and Access Anti-HAV IgM Assays EU Clinical Trial Protocol (HAV-EU-11-23) - NCT ID: NCT06289868 - Study ID: DC-TR23-0222 - Status: NOT_YET_RECRUITING - Start Date: 2024-02-27 - Completion Date: 2024-08-27 - Lead Sponsor: Beckman Coulter, Inc. ### Study Description The purpose of this study is to evaluate the clinical performance supporting that intended purpose of the Access anti-HAV as an aid in the laboratory diagnosis of HAV infection and for detection of anti-HAV after vaccination and of the Access anti-HAV IgM assay as an aid in the laboratory diagnosis of acute or recent HAV infection, on the DxI 9000 Access Immunoassay Analyzer.This study will be used to obtain CE mark for both Access anti-HAV and anti- HAV IgM assays. ### Conditions - HAV ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Access anti-HAV and Access anti-HAV IgM on the DxI 9000 Access Immunoassay Analyzer and CE-marked predicate assays - Access anti-HAV on the DxI 9000 Access Immunoassay Analyzer and CE-marked predicate assays ### Outcomes Primary Outcomes - Access Anti-HAV diagnostic accuracy measured as sensitivity and specificity - Access Anti-HAV IgM diagnostic accuracy measured as sensitivity and specificity Secondary Outcomes ### Location - Facility: Cerba Xpert, Frepillon, N/A, 95740, France @@
## Impulse Control Disorder Among Parkinson's Disease Patients - NCT ID: NCT06289855 - Study ID: Parkinson's disease - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2025-03-31 - Lead Sponsor: Assiut University ### Study Description The goal of this observational study is to learn about impulse control disorders in Parkinson's disease patients.The main question: it aims to answer:* Detect Relative frequency of impulse control disorder among Parkinson's disease patients* Detect Relation between impulse control disorders, and other non motor and motor symptoms in Parkinson's disease patients, using clinical, neurophysiological and radiological assessment ### Conditions - Parkinson's Disease ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - MDS-UPDRS ### Outcomes Primary Outcomes - number of patients with impulse control disorder among Parkinson's disease patients Secondary Outcomes - percent of cognition affection, gait affection among patients with impulse control disorder among Parkinson's disease patients - volume of cortex and basal ganglia in patients with impulse control disorder among Parkinson's disease patients - cortical excitability and inhibition inpatients with impulse control disorder among Parkinson's disease patients ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Accelerated Theta Burst Stimulation for Treatment of Suicidality in Depressed Patients - NCT ID: NCT06289842 - Study ID: ZU-IRB #9697 - Status: RECRUITING - Start Date: 2024-02-01 - Completion Date: 2026-01 - Lead Sponsor: Zagazig University ### Study Description The objective of this study is to investigate efficacy of accelerated theta burst stimulation (TBS) in suicidal reduction in patients with unipolar and bipolar depression ### Conditions - Suicide and Depression ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Transcranial Magnetic Stimulation MagPro R30 with the MCF-B70 figure-of-eight coil (MagVenture, Denmark) ### Outcomes Primary Outcomes - Change in suicidal ideation and behaviors as measured by Columbia Suicide Severity Rating Scale (C-SSRS) Secondary Outcomes - Change from baseline Montgomery-Åsberg Depression Rating Scale (MADRS) Score ### Location - Facility: Zagazig University, Zagazig, N/A, 44519, Egypt @@
## The Appropriate Remifentanil Dose for Optimal Insertion of Laryngeal Mask Airway in Adult Patients During Induction of General Anesthesia Using Remimazolam. - NCT ID: NCT06289829 - Study ID: 4-2023-1605 - Status: RECRUITING - Start Date: 2024-03-02 - Completion Date: 2025-07-29 - Lead Sponsor: Yonsei University ### Study Description The laryngeal mask airway (LMA) is an airway maintenance device that is easy to insert and has the advantage of causing less sore throat and autonomic nervous system stimulation. To appropriately insert the LMA, an adequate depth of anesthesia is essential. Various drugs have been studied for inducing anesthesia to achieve the appropriate depth for LMA insertion, and the newly developed benzodiazepine, remimazolam, is gaining attention as one of them. Remimazolam has rapid onset and recovery times, hemodynamic stability, and is often co-administered with opioids like remifentanil for more effective LMA insertion. This study aims to find the optimal dose of remifentanil for the proper insertion of the Ambu Auragain, one of the recently developed LMAs, during induction of anesthesia using remimazolam and the Biased-Coin Up-and-Down method will be used for this purpose. Starting with an initial concentration of remifentanil of 3.0 μg/mL, the success or failure of LMA insertion will determine the dosage for the next subject. Data will be collected from a total of 60 patients, and subsequent analysis will be conducted. ### Conditions - Adult, Laryngeal Masks, Remimazolam, Remifentanil ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SEQUENTIAL - Primary Purpose: OTHER ### Interventions - remifentanil of the assigned dose - Ambu Auragain for airway management ### Outcomes Primary Outcomes - Success/failure of LMA insertion on the first attempt Secondary Outcomes - Difficulty of LMA insertion - Optimality of the LMA insertion based on the administered remifentanil dose - The number of attempts required for successful LMA insertion and whether intubation was performed. - Air leak volume during positive-pressure ventilation - Systolic blood pressure - Heart rate - Patient State Index (PSI) - Severity of hoarseness - Severity of coughing - Severity of sore throat - Diastolic blood pressure ### Location - Facility: Severance Hospital, Seoul, N/A, N/A, Korea, Republic of @@
## Spleen Preserving Surgery for Splenic Hydatidosis: A Cohort Study on Short and Long-Term Outcomes - NCT ID: NCT06289816 - Study ID: 28/01/2023 - Status: COMPLETED - Start Date: 2015-01-01 - Completion Date: 2021-06-30 - Lead Sponsor: Yarmouk University ### Study Description This retrospective cohort study examines the effectiveness of minimally invasive spleen-preserving surgeries compared to total splenectomy for treating primary splenic hydatidosis in Jordan. Covering 18 patients from January 2015 to June 2021, the research highlights similar recurrence rates between both surgical approaches, emphasizing the benefits of spleen preservation in maintaining immune function and reducing septic risks, particularly in pediatric patients. ### Conditions - Spleen-Preserving Surgery - Echinococcus Granulosus Infection - Hydatid Disease - Minimally Invasive Surgery ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Minimally Invasive Surgery ### Outcomes Primary Outcomes - Incidence of Postoperative Short-Term Complications - Incidence of Postoperative Long-Term Complications Secondary Outcomes ### Location - Facility: Anas Aljaiuossi, Irbid, N/A, 22110, Jordan @@
## The Application of Probe Confocal Laser Endomicroscopy in Pancreatic Tumor Surgery - NCT ID: NCT06289803 - Study ID: Huadong Hospital of FudanU - Status: RECRUITING - Start Date: 2023-09-01 - Completion Date: 2025-06-30 - Lead Sponsor: Fudan University ### Study Description Aim of the study: To evaluate the value of Probe Confocal Laser Endomicroscopy (PCLE) in surgery for pancreatic tumor.Methods:Patients who are diagnosed with pancreatic tumor based on preoperative radiographic findings and will undergo radical resection are included in this clinical study. PCLE will be used in surgery to identify tumor is malignant or not, and surgeons will decide procedures of surgery based on outcomes of PCLE. In this present study, clinical trials will be divided into two phases. In the first phase, based on the definitive postoperative pathologic diagnosis, characteristic imaging structures that were collected by PCLE will be identified and primary diagnostic imaging criteria for pancreatic cancer would be developed. In the second phase, this criterion will be used for rapid intraoperative diagnosis of pancreatic cancer and predicting status of resection margin. In addition, accuracy of PCLE will be verified based on postoperative pathologic reports. ### Conditions - Pancreatic Cancer - Diagnosis - Pancreatoduodenectomy - Distal Pancreatectomy ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - probe confocal laser endomicroscopy ### Outcomes Primary Outcomes - diagnostic efficacy Secondary Outcomes - Rate of R0 resection ### Location - Facility: Huadong Hospital affiliated to Fudan University, Shanghai, Shanghai, 200040, China @@
## Erector Spinae Plane (ESP) Block vs Intravenous Lignocaine Infusion in (VATS) - NCT ID: NCT06289790 - Study ID: 16/BW/2023' - Status: NOT_YET_RECRUITING - Start Date: 2024-02-26 - Completion Date: 2024-11-07 - Lead Sponsor: Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland ### Study Description The goal of this clinical trial is to compare analgesic efficacy of erector spinae plane (ESP) block vs intravenous lignocaine infusion in video- assisted thoracoscopy (VATS. The main goals are to compare post- operative pain scores and cumulative post- operative opioid doses in both groups ### Conditions - Thoracic Surgery, Video-Assisted ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Erector Spinae Plane (ESP) block - Lignocaine ### Outcomes Primary Outcomes - pain score on numerical rating score - cumulative opioid dose Secondary Outcomes - incidence of severe hypotension - incidence of nausea and vomiting - incidence of priuritis - incidence of local anaesthetic systemic toxicity symptoms - intra-operative cumulative opioid dose - time to discharge from hospital ### Location - Facility: National Medical Institute of the Ministry of the Interior and Administration, Warsaw, Mazowieckie, 02-507, Poland @@
## Aortic Remodeling After Endovascular Management of Type B Aortic Dissection. - NCT ID: NCT06289777 - Study ID: aortic remodeling - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2026-04-01 - Lead Sponsor: Assiut University ### Study Description Assess the clinical outcome, morphological changes and behaviour of type B aortic dissection after endovascular repair. ### Conditions - Type B Aortic Dissection ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - TEVAR ### Outcomes Primary Outcomes - Analysis of aortic remodeling - technical success Secondary Outcomes ### Location - Facility: Faculty of Medicine, Asyut, N/A, 71515, Egypt @@
## The Effect of Aromatherapy Application With Bergamot and Grapefruit Essential Oils on PMS - NCT ID: NCT06289764 - Study ID: 7/02/2024/131 - Status: RECRUITING - Start Date: 2024-02-01 - Completion Date: 2024-05-30 - Lead Sponsor: Esra ÖZER ### Study Description Aromatherapy is;the science of using highly concentrated essential oils or essences distilled from plants to take advantage of their therapeutic properties. Essential oils or essences are obtained from various parts of plants (root, leaf, flower, bark, fruit) and used therapeutically for physical and psychological well-being.Premenstrual syndrome (PMS) is a health problem characterized by the periodic occurrence of physical, cognitive, emotional and behavioral symptoms during the luteal phase of the menstrual cycle, ending with the onset of menstruation or with the alleviation of symptoms within a few days after the onset of menstruation. It is reported that approximately 80-95% of women complain of PMS complaints.Although the use of aromatherapy in womens health is widespread, there is no study comparing bergamot and grapefruit essential oils. The aim of this study was to determine the effect of aromatherapy with bergamot and grapefruit essential oils on premenstrual syndrome and menstrual symptoms. ### Conditions - Premenstrual Syndrome-PMS ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Bergamot Essential Oil - Grapefruit Essential Oil - Sweet almond oil ### Outcomes Primary Outcomes - Premenstrual syndrome scale (PMS) Secondary Outcomes - Menstrual Symptom Scale ### Location - Facility: Ankara Medipol Unıversty, Ankara, Altındağ, 06000, Turkey @@
## Neoadjuvant Chemoimmunotherapy and Extrafascial Hysterectomy for IB2 Cervical Cancer - NCT ID: NCT06289751 - Study ID: NACI-CerV-004 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2031-01-01 - Lead Sponsor: Tongji Hospital ### Study Description This study is an exploratory clinical trial to investigate the feasibility of neoadjuvant chemoimmunotherapy plus extrafascial hysterectomy and pelvic lymph node dissection in patients with stage IB2 (2018 FIGO) cervical cancer and to observe the response rate to treatment, adverse effects and complications, and to assess the survival rate of patients. ### Conditions - Cervical Cancer - Neoadjuvant Chemoimmunotherapy - Radical Hysterectomy - Fertility Preservation ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Cadonilimab - Paclitaxel-albumin - Cisplatin - Extrafascial hysterectomy ### Outcomes Primary Outcomes - Percentage of patients meeting ConCerV criteria Secondary Outcomes - Objective Response Rate, ORR - Proportion of patients requiring postoperative adjuvant therapy - Number of Participants with Treatment-Emergent Adverse Events as assessed by CTCAE v4.0 - the surgical complication - Pathologic Complete Response - Overall survival, OS - progression-free survival, PFS ### Location - Facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, 430030, China @@
## ICF in Takayasu Arteritis - NCT ID: NCT06289738 - Study ID: ICF in Takayasu Arteritis - Status: RECRUITING - Start Date: 2024-02-21 - Completion Date: 2024-03-25 - Lead Sponsor: Pamukkale University ### Study Description The aim was to analyze the problem in patients with Takayasu Arteritis based on the International Classification of Functioning, Disability and Health.The sample of our study will consist of individuals between the ages of 18-65 who have been diagnosed with Takayasu Arteritis by rheumatologists and are followed by Pamukkale University Rheumatology Clinic. ### Conditions - Takayasu Arteritis ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - ICF ### Outcomes Primary Outcomes - 6 open-ended questions Secondary Outcomes ### Location - Facility: Elif Gur Kabul, Uşak, N/A, N/A, Turkey @@
## Impact of Hepatitis B Virus Genotype on Treatment Response in Children With Chronic Hepatitis B - NCT ID: NCT06289725 - Study ID: IRB-VN01002-23932 - Status: RECRUITING - Start Date: 2024-01-01 - Completion Date: 2026-01-01 - Lead Sponsor: Ly Hoa Anh Minh ### Study Description The study aimed to evaluate the relationship between hepatitis B virus genotype and treatment response in children with chronic hepatitis B with specific treatment indications. This is a prospective cohort study, with a follow-up period of at least 12 months, conducted at Children's Hospital 1 and City Children's Hospital, Ho Chi Minh City, Vietnam. The patient's blood was taken to be tested for hepatitis B virus genotyping using Sanger sequencing at the Center for Molecular Biomedicine Ho Chi Minh City. The research hypothesis is that genotype is related to treatment response. ### Conditions - Chronic Hepatitis b ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - antiviral treatment ### Outcomes Primary Outcomes - Serological response for HBeAg Secondary Outcomes - Virological response ### Location - Facility: Children's Hospital 1, Ho Chi Minh City, N/A, N/A, Vietnam @@
## Evaluation of the Ablation of Hepatic Lesions by Electroporation - NCT ID: NCT06289712 - Study ID: APHP231660 - Status: RECRUITING - Start Date: 2023-11-23 - Completion Date: 2025-05-23 - Lead Sponsor: Assistance Publique - Hôpitaux de Paris ### Study Description Irreversible electroporation is a curative treatment for cancerous liver lesions, performed on deep-seated tumors that are not eligible for surgical resection or percutaneous thermal ablation.The EVALHEP project aims to develop criteria for evaluating the effectiveness of the treatment based on imaging, mathematical models, and numerical simulations to assist radiologists who perform these complex procedures. ### Conditions - Liver Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Correlate 3D numerical simulations of the IRE electric field with patient imaging follow-up Secondary Outcomes - Calculation of the tumor coverage rate by the various electric field isolines at different relevant values (for example, three-dimensional isolines between 300 and 700V.cm-1 will be simulated numerically). - Correlation of recovery rate with treatment outcome and local recurrence during clinical follow-up - Identification and assessment of imaging biomarkers (radiomics-based) using numerical simulation and post-therapeutic imaging for treatment response evaluation. - Digital resolution of electrical potential and tissue conductivity values from test pulses at the start of the procedure. - Develop software solutions potentially usable in real-time and tailored for clinical use. ### Location - Facility: Service d'imagerie diagnostique et interventionnelle tri-site des HUPSSD, Bobigny, N/A, 93009, France @@
## Alert Frequency, Nurse, and Patient Satisfaction With a wCVSM Software Across Health Care Systems and Cultures - NCT ID: NCT06289699 - Study ID: WARD-CSS international 1251 - Status: RECRUITING - Start Date: 2024-02-26 - Completion Date: 2024-12-31 - Lead Sponsor: Christian S. Meyhoff ### Study Description The goal of this prospective, international multi-centre pilot study is to assess the functionality and user experience of a new vital sign monitoring system in 20 patients and 20 nurses in the general ward at each centre. The patients will be monitored with a wireless, continuous vital sign monitoring systems and answer a questionnaire afterwards. They will in addition have vital signs monitored as per standard practice. The nurses will answer a questionnaire after having had the responsibility for a monitored patient for a full shift. The main aims are: To determine the frequency of alerts activated in the app in relation to the alerts that should be activated based on measured data, to explore current practices of in-hospital monitoring by semi-structured interviews to map differences across systems and to test nurse and patient satisfaction. ### Conditions - User Experience - Postoperative Complications - Acute Medical Conditions ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Frequency of alerts activated in the app in relation to the alerts that should be activated based on measured data Secondary Outcomes - Technical feasibility - Alert relay to smartphones - Response to alerts - Patients experiences from being monitored with wCSVM. - Relevance of alarms - Frequency of delivered alarms on oxygen saturation (SpO2) pr patient pr day - Frequency of delivered alarms on respiration rate (RR) pr patient pr day - Frequency of delivered alarms on heart rate (HR) pr patient pr day - Frequency of delivered alarms on blod pressure (BP) pr patient pr day - Overall score of user satisfaction from use of WARD24/7 app - Subscale MAUQ scores - Monitoring practices prior to the wCVSM ### Location - Facility: The Cleveland Clinic Foundation, General Anesthesiology, Cleveland, Ohio, 44195, United States @@
## MIRROR Project 44 - Rotator Cuff Repairs With or Without BioEnthesis™ Augmentation - NCT ID: NCT06289686 - Study ID: C.2023.080 - Status: RECRUITING - Start Date: 2024-03 - Completion Date: 2025-12 - Lead Sponsor: Brooke Army Medical Center ### Study Description Rotator cuff (RC) injuries are particularly prevalent, difficult to repair, and attachment between the bone and tendon is notoriously difficult to achieve. The most common method and current standard of care (SOC) for reattaching connective tissues (e.g., ligaments, tendons) to bone typically involves suture anchor-based techniques, but this is fraught with problems. More specifically, re-tearing of the connective tissue after this procedure occurs in 30-60% of cases, and can be even higher in patients who engage in smoking, have a diagnosis of diabetes, etc. To address these clinical challenges, Sparta Biopharma Inc. (Sparta) developed a unique technology, called BioEnthesis, to improve the connection between the tendon and bone. Pre-clinical in vivo studies demonstrated that the biphasic bovine cancellous matrix regenerated at the bone-soft tissue interface-thereby leading to high structural integrity and will likely lead to reduced re-tear rates over time. The investigators hypothesize that patients in this interventional cohort will experience enhanced mobility, reduced pain, and less re-tears after RC procedures versus a standard suture anchor-based repair. ### Conditions - Rotator Cuff Tears - Rotator Cuff Injuries - Surgery ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Rotator cuff repairs with BioEnthesis augmentation - Rotator cuff repairs without BioEnthesis augmentation ### Outcomes Primary Outcomes - Rates of re-tear Secondary Outcomes - Change in the Visual Analogue Scale (VAS) from before surgery to after surgery - Change in the return to activities of daily living (ADL) from before surgery to after surgery - Change in the Concomitant medications (ConMeds) from before surgery to after surgery - Change in the Single Assessment Numeric Evaluation (SANE) from before surgery to after surgery - Change in the American Shoulder and Elbow Surgeons Standardized Shoulder Form (ASES) from before surgery to after surgery - Change in the Constant-Murley Score from before surgery to after surgery - Change in the shoulder immobilization status from before surgery to after surgery - Change in strength measurements from before surgery to after surgery - Change in range of motion measurements from before surgery to after surgery - Number of medical events/adverse events after surgery - Cumulative number of steroid injections after surgery - Number of unscheduled visits after surgery - Number of for-cause imaging procedures ### Location - Facility: Walter Reed National Military Medical Center, Bethesda, Maryland, 20889, United States @@
## Identification of Necessary Information for Treatment Induction in Newly Diagnosed Acute Lymphoblastic Leukemia/Lymphoma - NCT ID: NCT06289673 - Study ID: INITIALL - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2039-05 - Lead Sponsor: St. Jude Children's Research Hospital ### Study Description The goal of this study is to provide sufficient therapy during the time a patients' B-cell Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Leukemia (LLy) risk category is being determined. The term "risk" refers to the chance of the ALL or LLy coming back after treatment.Primary Objectives* To provide sufficient therapy to enable testing of newly diagnosed acute lymphoblastic leukemia/lymphoma and mixed phenotype acute leukemia/lymphoma tumor samples to determine eligibility and appropriate risk stratification for SJALL therapeutic studies.* To develop a central database of genomic and clinical findings.Secondary Objectives* To assess event free and overall survival data of patients enrolled on this study. ### Conditions - Acute Lymphoblastic Leukemia - Lymphoblastic Lymphoma - Mixed Phenotype Acute Leukemia ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Dexamethasone - Vincristine - Daunorubicin - Intrathecal triple therapy (methotrexate + hydrocortisone + cytarabine) - Methotrexate - Cytarabine ### Outcomes Primary Outcomes - Sufficient phenotypic and/or genomic data necessary for therapeutic protocol assignment by Day 8 (completion of INITIALL therapy). - Complete data within the INITIALL database Secondary Outcomes - Event Free Survival (EFS) - Overall Survival (OS) ### Location - Facility: United States, Tennessee St. Jude Children's Research Hospital, Memphis, Tennessee, 38105, United States @@
## Multicenter Italian Cohort Study on Tuberculosis in Pediatric Age - NCT ID: NCT06289660 - Study ID: PED-TB22 - Status: RECRUITING - Start Date: 2022-12-22 - Completion Date: 2033-03-01 - Lead Sponsor: Meyer Children's Hospital IRCCS ### Study Description According to the WHO report of 2021, approximately 10 million new cases were reported in 2020, of which 1 million occurred in the pediatric population. However, epidemiological data available on tuberculosis (TB) in pediatric age are extremely limited due to diagnostic challenges in this patient category. Furthermore, children are almost never included in national surveillance systems due to the lack of connections between individual pediatricians, pediatric hospitals, and national surveillance programs. It is therefore reasonable to assume that the disease may be significantly underestimated both in Italy and worldwide. ### Conditions - Tuberculosis Infection ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Epidemiology of Tuberculosis Secondary Outcomes ### Location - Facility: Meyer Children's Hospital IRCCS, Florence, Firenze, 50139, Italy @@
## Azithromycin Reduction to Reach Elimination of Trachoma B - NCT ID: NCT06289647 - Study ID: 19-28923B - Status: NOT_YET_RECRUITING - Start Date: 2024-02-28 - Completion Date: 2029-08-31 - Lead Sponsor: University of California, San Francisco ### Study Description The investigators propose a randomized controlled trial of discontinuation versus continuation of annual mass azithromycin distribution in hypoendemic communities of Maniema, DRC. The investigators will randomize communities with up to 20% Trachomatous Inflammation - Follicular (TF) prevalence following at least 5 years of mass azithromycin distribution to discontinuation or continuation of 3 additional years of annual mass azithromycin distribution. ### Conditions - Trachoma ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Azithromycin ### Outcomes Primary Outcomes - Ocular chlamydia measured in a population-based sample of 0-9 year-old children Secondary Outcomes - Infectious load of chlamydia among 0-9-year-old children infected with ocular chlamydia - Conjunctival inflammation ### Location - Facility: University of California, San Francisco, Kindu, Maniema, N/A, Congo, The Democratic Republic of the @@
## The Influence of Sound on Stress, Anxiety, and Mood - NCT ID: NCT06289634 - Study ID: Pending - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2024-04 - Lead Sponsor: Medgar Evers College, The City University of New York ### Study Description Multiple studies have highlighted music's ability to evoke diverse emotional states. Past research reveals that factors like musical elements, and the environment impact how people respond emotionally to music. For instance, faster tempos tend to heighten arousal, while minor key compositions evoke more arousal compared to major key compositions. In efforts to induce specific emotions post-stress, the research found that both pleasant and sad music aided stress recovery. Similarly, other researchers noted that positively rated music was more effective in reducing stress than negatively rated music, especially low arousal compositions over high arousal ones. Several studies focused on applying music to reduce stress and anxiety. In addition to man-made musical tones, the positive impact of natural surroundings on emotional state has been widely explored. A psycho-evolutionary viewpoint was offered, suggesting that humans have evolved in natural settings, making us inherently attuned to them physically and psychologically. A non-threatening natural environment, rich in aesthetically pleasing elements like visible escape routes, greenery, and water, tends to reduce stress and generate interest. In this study, the researchers are exploring how different sounds-man-made instrumental music versus natural sounds-affect stress, anxiety, and mood among the students of Medgar Evers College. Using an experimental approach, the researchers will assess pretest stress levels (via the perceived stress scale (PSS), anxiety (generalized anxiety disorder (GAD-7), and mood (four-dimensional mood scale (4DMS) among a sample of students. After randomly dividing them into two groups, each group will listen to one of the designated sounds (man-made music or nature sounds) for 30 minutes daily over 15 days. The researchers will then have them retake the stress, anxiety, and mood scales for post-test comparison. Statistical analysis (mixed ANOVA) will help to compare scores within and between groups. Ultimately, this study aims to determine the influence of tonal input on stress and anxiety levels among students, crucial given the significant stress they often experience. ### Conditions - Healthy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Man-made sounds - Natural sounds ### Outcomes Primary Outcomes - Stress - Anxiety - Mood Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Brief Transdiagnostic Treatment for Anxiety Disorders and Post-traumatic Stress Disorder (PTSD) in South Africa - NCT ID: NCT06289621 - Study ID: 2024P000420 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2026-12-31 - Lead Sponsor: Massachusetts General Hospital ### Study Description The purpose of this study is to examine the use of a brief transdiagnostic treatment for anxiety disorders and (post-traumatic stress disorder (PTSD) in South Africa. The intervention will be delivered by non-specialist providers (e.g., nurses) in primary care clinics. The brief intervention group will be compared to an enhanced standard care control group. ### Conditions - Anxiety Disorders - Post-traumatic Stress Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - False Safety Behavioral Elimination Treatment (FSET) - Enhanced Standard Care ### Outcomes Primary Outcomes - Structured Clinical Interview for the DSM-5 (SCID-5) - Clinician-Administered PTSD Scale for the DSM-5 (CAPS) - Work Social Adjustment Scale (WSAS) - General Anxiety Disorder-7 (GAD-7) - Beck Anxiety Inventory (BAI) - Safety Aid Scale (SAS) Secondary Outcomes - Post-traumatic Disorder Checklist (PCL-5 PTSD Checklist (PCL-5) - Patient Health Questionnaire - 9 (PHQ-9) - Beck Depression Inventory (BDI) - Anxiety Sensitivity Index -3 ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Bruxism and Underlying Psichological Factors - NCT ID: NCT06289608 - Study ID: ID_2024 - Status: RECRUITING - Start Date: 2023-02-01 - Completion Date: 2024-03-01 - Lead Sponsor: University of Salamanca ### Study Description The aim of this study was o determine the relationship between self-reported bruxism (SB) and some psychological factors (i.e: Anxiety State-Trait; Stress Reactivity Index, Beck Depression Inventory). A consecutive sample of 101 patients that reported at least 2 of the 6 items of Bruxism self-reported index, were explored clinically for quantifying the number and severity of worn teeth, and also the severe and location of the muscular pain according to an standardized inventory. ### Conditions - Bruxism - Muscular Disorders, Atrophic - Temporomandibular Joint Disorders ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - No intervention ### Outcomes Primary Outcomes - Depression Level - Stress Level - Anxiety Secondary Outcomes ### Location - Facility: Clinica Odontológica de la Universidad de Salamanca, Salamanca, N/A, 37007, Spain @@
## Impact of Photobiomodulation on Pain Associated With Orthodontic Treatment - NCT ID: NCT06289595 - Study ID: Pro00134382 - Status: COMPLETED - Start Date: 2023-10-03 - Completion Date: 2024-02-20 - Lead Sponsor: PBM Healing International Limited ### Study Description Orthodontic treatment can cause pain. Research studies have shown that light therapy can help reduce pain that is caused by orthodontic treatment. In this study, data was collected from the medical charts of patients who had orthodontic treatment and recorded their pain levels for 1 week at the beginning of orthodontic treatment while they used a light therapy device or did not use at device. This collected information was used to see if the light therapy device could lessen orthodontic pain. ### Conditions - Orthodontic - Pain ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - PBM Ortho device ### Outcomes Primary Outcomes - Level of Pain Secondary Outcomes ### Location - Facility: Bio Dental Clinic Ashiya, Ashiya, N/A, N/A, Japan @@
## Longitudinal TSPO PET Imaging With [18F]DPA-714 in PPMI (PPMI DPA-714 PET Imaging) - NCT ID: NCT06289582 - Study ID: R24-004 - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2027-06 - Lead Sponsor: University of Alabama at Birmingham ### Study Description The overall goal of this protocol is to investigate \[18F\]DPA-714 binding in prodromal and early manifest Parkinson's Disease (PD) and to determine the baseline and change from baseline in \[18F\]DPA-714 binding in PD participants during a 24-month interval.Primary Objectives* To compare \[18F\]DPA-714 binding in prodromal and manifest PD and healthy volunteers.* To determine the longitudinal change in \[18F\]DPA-714 during a 24-month interval for prodromal and early initially untreated PD participants.Secondary Objectives* To evaluate the correlation between baseline \[18F\]DPA-714 and PPMI clinical and biomarker outcomes.* To evaluate the correlation between the longitudinal change of \[18F\]DPA-714 and PPMI clinical and biomarker outcomes* To acquire safety data following injection of \[18F\]DPA-714 ### Conditions - Parkinson Disease ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: DIAGNOSTIC ### Interventions - [F-18]DPA714 administration IV ### Outcomes Primary Outcomes - Measure baseline and follow up regional brain TSPO levels using [18F]DPA-714-PET in prodromal PD. Secondary Outcomes ### Location - Facility: UAB, Birmingham, Alabama, 35294, United States @@
## Home Tele Rehabilitation Therapy for Vascular Dementia - NCT ID: NCT06289569 - Study ID: PRO00037243 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-14 - Completion Date: 2026-04-01 - Lead Sponsor: The Methodist Hospital Research Institute ### Study Description To determine whether the home telerehabilitation therapy is feasible and lessens caregiver burden in chronic stroke patients with and without vascular dementia (VaD) ### Conditions - Dementia, Vascular - Stroke Sequelae ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - Home telerehabilitation therapy ### Outcomes Primary Outcomes - Burden Scale for Family Caregivers - Adverse events Secondary Outcomes - Fugl-Meyer Upper extremity assessment - Wolf Motor Function Test (WMFT) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## [Trial of device that is not approved or cleared by the U.S. FDA] - NCT ID: NCT06289556 - Study ID: TEMP0001 - Status: WITHHELD - Start Date: N/A - Completion Date: N/A - Lead Sponsor: [Redacted] ### Study Description No description available. ### Conditions - No conditions listed. ### Study Design - Type: N/A - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Preoperative Oral Carbohydrate on Gastric Emptying - NCT ID: NCT06289543 - Study ID: BVU-ESTELOGLU - Status: RECRUITING - Start Date: 2023-01-01 - Completion Date: 2024-04-15 - Lead Sponsor: Bezmialem Vakif University ### Study Description The current preoperative fasting guidelines recommend, applying preoperative carbohydrate solution 2 hours before the operation to minimize prolonged fasting time potential negative effects and improve patient comfort. Fasting after midnight before the operation day is a widespread practice. The major obstacle to preoperative carbohydrate solutions becoming prevalent and extremely long fasting time is the limited product; which is proven safe and efficient, and unavailable in several countries. In this study, our objective is to analyze the gastric volume, preoperative anxiety, stress response, postoperative insulin resistance, and postoperative nausea and vomiting by utilizing a low osmolality oral carbohydrate solution prepared with ginger and melissa. ### Conditions - Vomit Aspiration - Anxiety ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Preoperative carbohydrate solution ### Outcomes Primary Outcomes - Gastric volume Secondary Outcomes - preoperative anxiety - postoperative nausea and vomiting - thirst, hunger, fatigue, dry mouth - Postoperative Pain Score - postoperative insulin resistance ### Location - Facility: Bezmialem University, Istanbul, Fatih, N/A, Turkey @@
## Association Between Perioperative Blood and Interstitial Fluid Glucose Level and Clinically Relevant Postoperative Pancreatic Fistula in Different Pancreatic Surgeries - NCT ID: NCT06289530 - Study ID: 2023XAGG0070-1 - Status: RECRUITING - Start Date: 2024-03-01 - Completion Date: 2024-10-01 - Lead Sponsor: Peking Union Medical College Hospital ### Study Description This observational study was conducted in patients undergoing elective pancreaticoduodenectomy or distal pancreatectomy. It mainly answers the following two main questions:1. What are the risk factors for clinically relevant postoperative pancreatic fistula in different pancreatic surgeries?2. What is the correlation between perioperative blood and interstitial fluid glucose level and clinically relevant postoperative pancreatic fistula in different pancreatic surgeries？Participants were not required to perform additional research work other than the usual postoperative follow-up within 30 days after surgery. No control group was set in this study, and no additional clinical intervention was performed. ### Conditions - Postoperative Pancreatic Fistula ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Clinically relevant postoperative pancreatic fistula Secondary Outcomes - Bile leakage - Chyle leak - Postpancreatectomy hemorrhage - Abdominal infection - Delayed gastric emptying ### Location - Facility: Peking Union Medical College Hospital,Chinese Academy of Medical Science and Peking Union Medical College, Beijing, Beijing, 100730, China @@
## PET Imaging of 68Ga-Her2-affibody in Tumors With High Her2 Expression - NCT ID: NCT06289517 - Study ID: 68Ga-Her2-affibody - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2025-06-30 - Lead Sponsor: Peking University First Hospital ### Study Description This project uses HER2 protein as the target group of radiodrugs to explore the diagnostic efficacy, safety and metabolic characteristics of 68Ga-Her2-affibody in the expression status of HER2, aiming to provide a new imaging method for the determination of HER2 status in breast cancer At the same time, it also provides new methods and means for early diagnosis, accurate staging, recurrence judgment, treatment decision-making and prognosis judgment of malignant tumors such as lung cancer, gastrointestinal cancer and bladder cancer, and provides scientific basis for precise treatment of malignant tumors. ### Conditions - Neoplasms ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - 68Ga-Her2-affibody ### Outcomes Primary Outcomes - The diagnostic efficacy of 68Ga-Her2-affibody PET/CT in the evaluation of breast cancer Secondary Outcomes - The dosimetry of 68Ga-Her2-affibody - Quantitative evaluation of 68Ga-Her2-affibody - Correlation with pathological expression ### Location - Facility: Peking University First Hospital, Beijing, Beijing, 100034, China @@
## A Study on How CagriSema Affects Levels of Atorvastatin and Warfarin in the Blood of Participants With Excess Body Weight - NCT ID: NCT06289504 - Study ID: NN9838-4694 - Status: RECRUITING - Start Date: 2024-02-27 - Completion Date: 2024-11-16 - Lead Sponsor: Novo Nordisk A/S ### Study Description This study will look at how CagriSema affects the blood levels of atorvastatin and warfarin. The study will look at the levels of warfarin and atorvastatin in the blood before the participant starts taking CagriSema and if this changes after the participant has taken CagriSema. The study will also investigate the effect of warfarin before and after the participant takes CagriSema and assess if the injection site affects the level of CagriSema in the blood. The study will last for about 8 months. ### Conditions - Obesity ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - Cagrilintide - Semaglutide - Atorvastatin - Warfarin ### Outcomes Primary Outcomes - AUC0-72hours,atorv,SD: Area under the atorvastatin plasma concentration-time curve from time 0 to 72 hours after a single dose of atorvastatin without CagriSema exposure and at CagriSema steady state - AUC0-168hours,S-war,SD: Area under the S-warfarin plasma concentration-time curve from time 0 to 168 hours after a single dose of warfarin without CagriSema exposure and at CagriSema steady state Secondary Outcomes - AUC0-∞,atorv,SD: Area under the atorvastatin plasma concentration curve from time 0 to infinity after single dose of atorvastatin without CagriSema exposure and at CagriSema steady state - Cmax,atorv,SD: Maximum observed atorvastatin plasma concentration after single dose of atorvastatin without CagriSema exposure and at CagriSema steady state - tmax,atorv,SD: Time to maximum observed atorvastatin plasma concentration after single dose of atorvastatin without CagriSema exposure and at CagriSema steady state - AUC0-∞,S-war,SD: Area under the S-warfarin plasma concentration curve from time 0 to infinity after single dose of warfarin without CagriSema exposure and at CagriSema steady state - Cmax,S-war,SD: Maximum observed S-warfarin plasma concentration after single dose of warfarin without CagriSema exposure and at CagriSema steady state - tmax,S-war,SD: Time to maximum observed S-warfarin plasma concentration after single dose of warfarin without CagriSema exposure and at CagriSema steady state - iAUCINR,0-168hours: Incremental area under the INR-curve from 0 to 168 hours after single dose of warfarin without CagriSema exposure and at CagriSema steady state - INRmax: Maximum observed INR response after single dose of warfarin without CagriSema exposure and at CagriSema steady state - tINRmax: Time to maximum observed INR response after single dose of warfarin without CagriSema exposure and at CagriSema steady state - Rac,0-168hours,Cagri: The ratio of the area under the cagrilintide plasma concentration curve from 0 to 168 hours after the 4th dose of CagriSema to the area under the plasma concentration curve from 0 to 168 hours after the 1st dose - Rac,0-168hours,Sema: The ratio of the area under the semaglutide plasma concentration curve from 0 to 168 hours after the 4th dose of CagriSema to the area under the plasma concentration curve from 0 to 168 hours after the 1st dose - AUC0-168hours, 4th dose Cagri: Area under the cagrilintide plasma concentration curve from 0 to 168 hours after 4th dose of CagriSema - AUC0-168hours,4th dose Sema: Area under the semaglutide plasma concentration curve from 0 to 168 hours after 4th dose of CagriSema ### Location - Facility: Altasciences Company Inc., Mount-Royal, Quebec, H3P 3P1, Canada @@
## Randomized Trial of Hydrus Microstent Versus Goniotomy - NCT ID: NCT06289491 - Study ID: 2024P000544 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2029-04 - Lead Sponsor: Massachusetts Eye and Ear Infirmary ### Study Description The goal of this clinical trial is to evaluate the comparative efficacy and safety of Hydrus Microstent, incisional goniotomy, and excisional goniotomy when combined with cataract surgery in patients with mild and moderate open-angle glaucoma. The main questions it aims to answer are:* How do the intraocular pressure lowering effects of these three microinvasive glaucoma surgeries compare?* How do the safety profiles of these three microinvasive glaucoma surgeries compare?Participants will be randomized to one of these three microinvasive glaucoma surgeries in combination with cataract surgery. ### Conditions - Glaucoma - Glaucoma, Open-Angle ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Hydrus Microstent - Incisional goniotomy - Excisional goniotomy ### Outcomes Primary Outcomes - Intraocular pressure - Intraocular pressure-lowering medications Secondary Outcomes - Surgical complications ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Efficacy and Safety of Retrograde Intraarticular Injection Via Drain Tube, Topical Soaking of Tranexamic Acid (TXA), or Placebo in Elderly Patients With Femoral Neck Fractures Undergoing Cementless Bipolar Hemiarthroplasty - a Randomized Controlled Trial - NCT ID: NCT06289478 - Study ID: 0151/67 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2026-04 - Lead Sponsor: King Chulalongkorn Memorial Hospital ### Study Description The goal of this Randomized controlled trial is to evaluate in household ambulatory, elderly patients sustaining femoral neck fracture who are subjected to be treat with cementless bipolar hemiarthroplasty. The main questions it aims to answer are:* The efficacy in reducing blood transfusion for topical tranexamic acid administration* The safety of tranexemic acid, topically usedAs having undergone bipolar hemiarthroplasty surgery, participants will either receive retrograde intraarticular tranexamic acid injection via drain tube, or topical soaking administration.Researchers will compare, with standard procedure (procedure), whether topically administered tranexamic acid would reduce rate of blood transfusion. ### Conditions - Femoral Neck Fracture - Bipolar Hemiarthroplasty ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Topical tranexamic acid administration ### Outcomes Primary Outcomes - Rate of blood transfusion Secondary Outcomes - Volume of blood transfusion - Calculated blood loss - Any adverse events - In-hospital mortality ### Location - Facility: Faculty of Medicine, Bangkok, N/A, 10330, Thailand @@
## Examination of Pain, Posture, Physical and Mental Status in Seasonal Hazelnut Workers - NCT ID: NCT06289465 - Study ID: IstanbulBU - Status: NOT_YET_RECRUITING - Start Date: 2024-09-01 - Completion Date: 2024-12-01 - Lead Sponsor: Istanbul Bilgi University ### Study Description The collection of hazelnuts grown in our country provides a great source of employment for local people and seasonal workers. However, geographical conditions in hazelnut growing areas, challenging variable weather conditions in August and insufficient number of workers create a disadvantageous environment for seasonal workers.In this study, it was aimed to investigate the effects of working conditions on mental status, fatigue, pain severity and postures (posture disorders, developmental delays, etc.) of young adults working in Giresun during the hazelnut picking season in comparison with the group living in the same sociodemographic and cultural environment but not working as seasonal workers. ### Conditions - Agricultural Workers' Diseases - Posture - Pain - Depression - Fatigue ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Observation ### Outcomes Primary Outcomes - McGill Melzack Questionnaire - PhysioPrint Mobile Application - Checklist Individual Strength Questionnaire Secondary Outcomes - Beck Depression Inventory ### Location - Facility: Istanbul Bilgi University, Istanbul, N/A, 34060, Turkey @@
## Safety and Efficacy Study of IVB102 Injection in Subjects With X-linked Retinoschisis - NCT ID: NCT06289452 - Study ID: IVB102-101 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-06 - Completion Date: 2029-12-31 - Lead Sponsor: InnoVec Biotherapeutics Inc. ### Study Description The goal of this clinical trial is to evaluate the safety and efficacy of IVB102 injection in subjects with XLRS. ### Conditions - Retinoschisis - Retinal Disease - Retinal Degeneration - Eye Diseases ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - IVB102 Injection - IVB102 Injection - IVB102 Injection ### Outcomes Primary Outcomes - Incidence of DLTs - Incidence of AEs - Incidence of SAEs Secondary Outcomes - Visual function - OCT imaging - ERG parameters ### Location - Facility: Peking Union Medical College Hospital, Beijing, Beijing, 100142, China @@
## Effect of Green Tea Supplementation in Older Adult Women - NCT ID: NCT06289439 - Study ID: 2024.05.25 - Status: RECRUITING - Start Date: 2024-03-05 - Completion Date: 2025-04-01 - Lead Sponsor: University of Valladolid ### Study Description Introduction: One of the consequences of aging is the decrease in physical performance which can affect the quality of life of older people. Although physical exercise is beneficial in improving this problem, older women do not seem to benefit as much as men. In this sense, the use of ergonomic aids by women could compensate for these issues. Thus, green tea has shown beneficial effects on physical performance in athletes through, among others, improving blood flow and vasodilation, mitochondrial respiration, calcium management, glucose and amino acid uptake, lipid oxidation, modulation of muscle damage, antioxidant effect, and anabolic and catabolic hormones, activation of the hypothalamic-pituitary-adrenal axis, etc. Therefore, the deterioration of physical performance and quality of life of green tea.Objective: To analyze the effect of supplementation with 1 g/day green tea extract (500 mg of polyphenols) for 10 weeks on quality of life values, physical performance (grip strength, walking speed, and resistance), and health biomarkers (biochemical, hematological, and hormonal) in women over 60 years of age who follow a physical training program.Methods: A total of 20 female volunteers between 60 and 73 years old (age: 65.9±4.58 years, BMI: 25.09±3.24 and body fat percentage: 32.54±6.39) who followed a physical activity adapted to their age and abilities are the members of this study. The volunteers were divided into two groups: placebo (CG; n = 10) and supplemented with 1 g/day of green tea (GI; n = 10). Different physical tests were performed (grip strength, walking speed and resistance) and the quality of life questionnaire (WHOQOL-BREF) was passed and health biomarkers (biochemical, hematological, and hormonal) were analyzed at the beginning (T1) and at the end of the 10 weeks of intervention (T2). ### Conditions - Female - Older Adults - Sarcopenia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Green tea (Camellia sinensis) 1000 mg as extract - Placebo ### Outcomes Primary Outcomes - Creatine kinase (CK) - Lactate dehydrogenase (LDH) Secondary Outcomes - Myoglobin (Mb) - Alanine Aminotransferase (ALT) - Aspartate Aminotransferase (AST) - Interleukin 6 (IL-6) - C-reactive protein (PCR) - Testosterone - Cortisol - Miostatin (GDF8) - advanced oxidation protein products (AOPP) - lipid peroxidation (LPO) - Oxygen radical absorption (ORAC) - Total antioxidant status (TAS) - Total antioxidant capacity (TAC) - Short Physical Performance Battery (SPPB) - World Health Organization Quality of Life - BREF (WHOQOL-BREF) ### Location - Facility: Faculty of Health Sciences, University of Valladolid Soria Campus, Soria, N/A, 42004, Spain @@
## Online Yoga for Improving the Well-being of Desk-based Workers - NCT ID: NCT06289426 - Study ID: KU3339 - Status: RECRUITING - Start Date: 2024-02-15 - Completion Date: 2024-08-15 - Lead Sponsor: Kingston University ### Study Description The goal of this clinical trial is to evaluate the effectiveness of an 8-week online yoga intervention in improving the well-being and productivity of desk-based workers. The main questions it aims to answer are:* How effective is an 8-week online yoga intervention in improving the well-being (mental and physical) and productivity (work engagement and job performance) of the yoga group compared with passive controls?* Are there any differences in well-being and work-related measures between the yoga and control groups?Participants in the yoga group will practice yoga three days a week for 8 weeks and will be compared with a wait-listed control group, which will continue with the usual routine for 8 weeks. Researchers will evaluate the impact of yoga on the well-being and productivity of desk-based workers. ### Conditions - Perceived Stress - Depression - Anxiety - Mindfulness - Self-Compassion - Compassion - Work Engagement - Productivity - Heart Rate Variability - Mental Wellbeing - Musculoskeletal Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Yoga ### Outcomes Primary Outcomes - Perceived Stress Scale - PROMIS-Anxiety Short form - The Short Warwick-Edinburgh Mental Well-being Scale (SWEMWBS) - The Mindful Attention Awareness Scale (MAAS) - The Cornell Musculoskeletal Discomfort Questionnaire (CMDQ) - Self-Compassion Scale Short Form (SCS-SF) - The Compassion Scale (CS) - Uterecht Work Engagment Scale-Short Form (UWES -9) - Work Ability Index (WAI) - Center for Epidemiologic Studies Short Depression Scale (CES-D-R 10) - Heart Rate Variability (HRV) Secondary Outcomes ### Location - Facility: Vipin Wadhen, London, N/A, KT12EE, United Kingdom @@
## Autonomic Dysfunction in Patients Following Bariatric Surgery: The ADiPOSE Study - NCT ID: NCT06289413 - Study ID: KCHRRF_ADiPOSE_0027 - Status: RECRUITING - Start Date: 2024-03 - Completion Date: 2026-06 - Lead Sponsor: Kansas City Heart Rhythm Research Foundation ### Study Description Observational two phase, retrospective and prospective registry study to assess the prevalence of and characterize outcomes of autonomic dysfunction (AD) in patients who undergo bariatric surgery (BS) and to better define the underlying pathophysiology of AD following BS. ### Conditions - Autonomic Dysfunction - Orthostatic Intolerance ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Development of AD/OI after BS ### Outcomes Primary Outcomes - To assess the prevalence of and characterize outcome of autonomic dysfunction (AD) in patients who undergo bariatric surgery (BS) Secondary Outcomes ### Location - Facility: Menorah Medical Center, Overland Park, Kansas, 66209, United States @@
## Magnetic Field Application in Patellofemoral Pain Syndrome - NCT ID: NCT06289400 - Study ID: KaratayUOAS - Status: RECRUITING - Start Date: 2024-02-26 - Completion Date: 2024-05-31 - Lead Sponsor: KTO Karatay University ### Study Description The purpose of this study is to examine the effect of magnetic field application used in the treatment of patellofemoral pain. ### Conditions - Pain, Knee ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Magnetic field application - Conventional treatment ### Outcomes Primary Outcomes - Visual Analogue Scale (VAS) - 36-Item Short Form Survey (SF-36) - Manual Muscle Test - The Lower Extremity Functional Scale (LEFS) Secondary Outcomes ### Location - Facility: KTO Karatay University, Konya, N/A, N/A, Turkey @@
## Combining Gene Variants to Improve Risk Prediction for Metabolic (Dysfunction)- Associated Fatty Liver Disease and Its Progression to Cirrhosis in Indian Individuals With Type 2 Diabetes - NCT ID: NCT06289387 - Study ID: MMDEF001 - Status: RECRUITING - Start Date: 2024-01-20 - Completion Date: 2025-01-10 - Lead Sponsor: Medanta, The Medicity, India ### Study Description Type 2 diabetes and metabolic (dysfunction)-associated fatty liver disease (MAFLD) often exist together. The prevalence of MAFLD is about 15-30% in healthy people and around 60-70% in people with type 2 diabetes. Moreover, type 2 diabetes accelerates the progression of liver disease in MAFLD.MAFLD is a spectrum of liver conditions, ranging from simple fatty liver (low risk for progression), progressing to steatohepatitis (MASH) with no or mild fibrosis, advanced liver fibrosis, cirrhosis, and hepatocellular carcinoma. Although diabetes is the strongest predictor of advanced fibrosis in MAFLD, however, only a small proportion of people with type 2 diabetes and MAFLD (about 5-7%) develop a clinically significant liver disease, but the burden of MAFLD is such that even a small proportion of patients developing cirrhosis will lead to a huge strain on the health care system in India. MAFLD is predicted to be the leading indication for liver transplantation in coming years. At present, MAFLD/MASH is the second most common indication for liver transplantation in the USA as well as in India.The question is why around 5-7% patients amongst MAFLD population develop fibrosis and cirrhosis. A growing body of evidence suggest that the disease develops because of a complex process in which several factors, including genetic susceptibility and environmental insults, are involved. There are several gene variants that have been incriminated in the development and progression of MAFLD. The most common genes associated with MAFLD are PNPLA3, TM6SF2, GCKR, and MBOAT7. The loss-of-function gene variant HSD17B13 seems to protect from NAFLD. There are a few studies from India about the role of PNPLA3 and TM6SF2 in MAFLD. However, these studies used USG for the diagnosis of MAFLD, which does not provide any information regarding fibrosis of the liver. The data regarding other three genetic variants are scarce from Indian individuals. ### Conditions - Type2diabetes ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Role of the PNPLA3, TM6SF2, GCKR, MBOAT7 and HSD17B13 genetic variants in the development and progression of MASLD. Secondary Outcomes - Correlation between body fat percentage (DEXA-measured) and the genetic variants - Correlation between lean body mass (as measured by DEXA) and the genetic variants - Correlation between bone mineral content (DEXA-measured) and the genetic variants - Correlation between fibrosis-4 score (FIB-4) and the genetic variants - Correlation between MASLD fibrosis score (NFS) and the genetic variants - Correlation between serum creatinine levels (eGFR) and the genetic variants ### Location - Facility: Medanta Division of Endocrinology & Diabetes, Gurgaon, Haryana, 122001, India @@
## Longitudinal Assessment of Biomarkers After Oesophagogastric Cancer Surgery - NCT ID: NCT06289374 - Study ID: 23HH8340 - Status: RECRUITING - Start Date: 2024-04 - Completion Date: 2029-06 - Lead Sponsor: Imperial College London ### Study Description Oesophagogastric cancer (cancer of the gullet and stomach) is the fifth most common cancer in England and Wales with 16,000 new cases diagnosed every year. Survival rates are poor with only 15% surviving beyond 5 years. There is also increasing research to understand the cancer biology and factors allowing cancers to progress. It is likely there is a relationship between the cancer-specific microbiome, cells related to inflammation, which promotes cancer progression. The BIORESOURCE 1 study has established a comprehensive resource of matched samples from patients with oesophageal and gastric cancer. This longitudinal study aims to obtain further matched biosamples in the follow-up period after cancer surgery to find biomarkers that may predict treatment response, recurrence and/or long term prognosis. ### Conditions - Oesophageal Adenocarcinoma - Gastric Adenocarcinoma ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Biosample collection ### Outcomes Primary Outcomes - Salivary microbial biomarkers to predict treatment response and long-term prognosis Secondary Outcomes - Breath volatile organic compound profile alterations of oesophagogastric cancer pre- and post- treatment - Quality of life measure up to 2 years following cancer surgery using validated questionnaires ### Location - Facility: Imperial College Healthcare NHS Trust, London, N/A, N/A, United Kingdom @@
## Cohort IMEA 070 -Lenacapavir Compassional - NCT ID: NCT06289361 - Study ID: IMEA 070 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2024-07-30 - Lead Sponsor: Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba ### Study Description Immunovirological follow-up and safety of HIV-infected patients receiving lenacapavir under compassionate access in France between 01/01/2021 and 12/31/2023 ### Conditions - HIV Infections ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - proportion of participants with plasma HIV RNA < 50 copies/ml 26 weeks after first LEN injection Secondary Outcomes - incidence of side effects and laboratory abnormalities on LEN treatment - evolution of HIV-1 or HIV-2 RNA over time - evolution of CD4, CD8 lymphocyte counts and CD4/CD8 ratio over time - Proportion of patients with capsid resistance mutations emergence at time of virological failure response) compared with initiation (D0) - Determination by multivariate analysis of factors associated with virological success 26 weeks after the first LEN injection factors associated with virological control 26 weeks after the first LEN injection ### Location - Facility: Hopital Zobda Quitman, Fort-de-France, Martinique, 97261, France @@
## Announcement of Rare Metabolic Diseases in Systematic Newborn Screening: the Phenylketonuria Experience. - NCT ID: NCT06289348 - Study ID: APHP230240 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2027-04 - Lead Sponsor: Assistance Publique - Hôpitaux de Paris ### Study Description The aims of this collaborative, interdisciplinary research project are to understand and describe the psychological impact of the announcement of a rare, serious disease present since birth and detected in the context of the systematic neonatal screening (DNS), in terms of the parents' experience, but also on the part of the medical team, in order to improve its process and the support it provides for the announcement of the diagnosis. ### Conditions - Phenylketonuria ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - socio-psychological questionnaire - revised event impact scale (IER-S) - Non directive interview - Stern interview - semi-directive interview ### Outcomes Primary Outcomes - Psychological process linked to the announcement of inherited metabolic disease for the parents - Psychological impact of the announcement of an inherited metabolic disease on the doctors' experience - Measuring awareness of inherited metabolic diseases detected by midwives Secondary Outcomes - Measure of the impact of the announcement on parents ### Location - Facility: Hôpital Necker Enfants Malades, Paris, N/A, 75015, France @@
## Dexmedetomidine Compared to Ondansetron for Postanaesthetic Shivering in Patients Undergoing a Cesarean Section - NCT ID: NCT06289335 - Study ID: HCDrIMPrieto anaesthesia - Status: COMPLETED - Start Date: 2020-08-05 - Completion Date: 2022-01-03 - Lead Sponsor: Hospital Central "Dr. Ignacio Morones Prieto" ### Study Description Evaluate the efficiency of management with intravenous dexmedetomidine compared to intravenous ondansetron to achieve the disappearance of post-anesthetic shivering in a shorter time in the obstetric patient undergoing cesarean section under regional anesthesia. ### Conditions - Postanesthetic Excitement - Cesarean Section ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - saline solution ### Outcomes Primary Outcomes - Period of time Secondary Outcomes - Adverse effects ### Location - Facility: Hospital Central Dr. Ignacio Morones Prieto, San Luis Potosí, N/A, 78290, Mexico @@
## AI4HOPE Dementia Pain Assessment Pilot Study 1 - NCT ID: NCT06289322 - Study ID: EU101136769-CLIN1 - Status: NOT_YET_RECRUITING - Start Date: 2025-07 - Completion Date: 2026-12 - Lead Sponsor: University of Bonn ### Study Description The pilot study will develop and test a standardized assessment toolkit that will provide conclusive information with a tolerable burden for cognitively impaired patients with dementia. ### Conditions - Dementia ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Digital toolkit for assessment ### Outcomes Primary Outcomes - Feasibility and acceptability of toolkit - Accuracy of toolkit assessments Secondary Outcomes - Effect of pain /distress interventions ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## NerveTrend vs. NerveAssure in Prevention of Recurrent Laryngeal Nerve Injury During Thyroid Surgery - NCT ID: NCT06289309 - Study ID: N41/DBS/001142 - Status: RECRUITING - Start Date: 2024-03-01 - Completion Date: 2025-06-30 - Lead Sponsor: Marcin Barczynski ### Study Description The aim of this study is to compare two distinct modes of NIM Vital application in thyroid surgery: NerveTrend vs. NerveAssure mode with respect to prevalence of early postoperative RLN injury.The hypothesis explored in this study is that NerveTrend mode may be not inferior than NerveAssure mode in intraoperative identification of impending neural injury and in prognostication of postoperative glottis function in monitored bilateral thyroid surgery. Hence, NerveTrend mode may be considered a bridge between i-IONM and NerveAssure modes, and particularly in health care environments with limited financial resources it can be considered a substantial step forward representing a modern alternative to the NerveAssure technique.A prospective, randomized study with 2 arms: NeveTrend vs. NerveAssure mode (n=132 patients and 264 nerves at risk, each).The primary outcome measure is prevalence of recurrent laryngeal nerve (RLN) injury (%) on postoperative day 1 assessed by direct laryngoscopy. ### Conditions - Thyroid Diseases - Surgery - Recurrent Laryngeal Nerve Injuries ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Neuromonitoring of the recurrent laryngeal nerves ### Outcomes Primary Outcomes - Prevalence of recurrent laryngeal nerve injury (%) assessed by direct laryngoscopy Secondary Outcomes - Positive predictive value (%) of introperative neuromonitoring of recurrent laryngeal nerves in prognostication of postoperative glottis function assessed by direct laryngoscopy - Negative predictive value (%) of introperative neuromonitoring of recurrent laryngeal nerves in prognostication of postoperative glottis function assessed by direct laryngoscopy - Prevalence of permanent recurrent laryngeal nerve injury (%) assessed by direct laryngoscopy ### Location - Facility: Department of Endocrine Surgery, Jagiellonian University College of Medicine, Krakow, N/A, 31-202, Poland @@
## Medium Chain Fatty Acids and Ketones - NCT ID: NCT06289296 - Study ID: MCT - Status: COMPLETED - Start Date: 2022-01-01 - Completion Date: 2023-09-30 - Lead Sponsor: University of Copenhagen ### Study Description 16 participants were randomized to complete two seven-day intervention periods with twice-daily consumption of Medium-chain fatty acids (MCT) or long-chain fatty acids (LCT) oil. Before and after each intervention, participants completed a five-hour experimental day evaluating the response to a first intake of the MCT or LCT oils (pre MCT or LCT), which was repeated after the intervention period of daily intake (post MCT or LCT) (Fig. The intervention periods were separated by a 2-4-week washout period. ### Conditions - Diet, Healthy - Health ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - Fatty acid intake in lean and obese males ### Outcomes Primary Outcomes - Ketone bodies in plasma Secondary Outcomes ### Location - Facility: University of Copenhagen, Copenhagen, N/A, 2100, Denmark @@
## Microbiota in Urine and Urothelium Can be a Factor for Induction of Urinary Bladder Cancer. The Study Will Examine Urine and Bladder Cancer Tissues From Male Patients and Urine of Controls Using Whole Genomic Sequencing Techniques and 16S rRNA. The Aim is to Elucidate Role of Microbiota in Bladder - NCT ID: NCT06289283 - Study ID: Theodor Bilharz Research Ins. - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-10-12 - Completion Date: 2026-12 - Lead Sponsor: Theodor Bilharz Research Institute ### Study Description Microbes inhabiting the urinary tract that are playing an important role in maintenance of health and the development of diseases and bladder cancer. There is correlation between initiation of bladder cancer and microbes. Urine and bladder tissues from healthy individuals and patients with bladder cancer were analyzed using 16S rRNA sequencing, results show abundant phylum. Next-generation sequencing technologies will be applied with whole genomic and 16S ribosomal RNA gene sequencing for microbiota profiling in urine and bladder tissue of male healthy individuals and patients with bladder cancer. Results will lead to prevention, diagnosis and new treatment strategies for bladder cancer. ### Conditions - Urinary Bladder Neoplasms - Microtia ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Urine samples and tissue samples: Samples will be collected in clean leak-proof containers without disinfectant or detergent residue and with tight-fitting leak-proof lids and preserved in a refrigera ### Outcomes Primary Outcomes - To characterize the microbiota in health and bladder cancer, and may lead to new prevention, diagnosis and treatment strategies for bladder cancer Secondary Outcomes ### Location - Facility: Theodor Bilharz Research Institute, Cairo, N/A, 12411, Egypt @@
## Microbiota in Urine and Urothelium Can be a Factor for Induction of Urinary Bladder Cancer. The Study Will Examine Urine and Bladder Tissues From Egyptian Male Patients and Controls Using Whole Genomic Sequencing Techniques and 16S rRNA. The Aim is to Elucidate Role of Microbiota in Bladder Cancer. - NCT ID: NCT06289270 - Study ID: Microbiota and bladder cancer - Status: RECRUITING - Start Date: 2023-09-20 - Completion Date: 2027-07 - Lead Sponsor: Theodor Bilharz Research Institute ### Study Description Microbes inhabiting the urinary tract that are playing an important role in maintenance of health and the development of diseases and bladder cancer. There is correlation between initiation of bladder cancer and microbes. Urine and bladder tissues from healthy individuals and patients with bladder cancer were analyzed using 16S rRNA sequencing, results show abundant phylum. Next-generation sequencing technologies will be applied with whole genomic and 16S ribosomal RNA gene sequencing for microbiota profiling in urine and bladder tissue of male healthy individuals and patients with bladder cancer. Results will lead to prevention, diagnosis, and new treatment strategies for bladder cancer. ### Conditions - Microbiota in Patients With Urinary Bladder Carcinoma in Urine and Cancer Tissues ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - To characterize the microbiota in male patients with bladder cancer. Secondary Outcomes ### Location - Facility: Theodor Bilharz Research Institute, Cairo, Giza, 12411, Egypt @@
## Association of Vitamin D Level and Its Receptor With Endometriosis - NCT ID: NCT06289257 - Study ID: VitDAndEndomet - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2024-09-30 - Lead Sponsor: Khon Kaen University ### Study Description Endometriosis, a condition where endometrial-like tissue grows outside the uterus, often occurs due to retrograde menstruation, where menstrual blood flows backward through the fallopian tubes into the pelvic cavity. This tissue can then implant and grow within the pelvic peritoneum. The survival of these ectopic implants leads to chronic inflammation, adhesion formation, and scarring of surrounding tissues, including the ovaries and fallopian tubes. Symptoms include cyclic pelvic pain, dysmenorrhea, dyspareunia, and infertility.Ectopic endometrial tissue survival is not attributed to mutations but rather epigenetic changes. Studies have linked this phenomenon to genes such as KRAS (Kirsten Rat Sarcoma Virus Oncogene), involved in cell proliferation and survival. Dysregulated KRAS activity can lead to increased production of MMP-2 and MMP-9 proteins, implicated in angiogenesis and tissue invasion, facilitating the spread of endometrial tissue.Vitamin D has been shown to modulate immune function and reduce inflammation. Studies suggest that vitamin D deficiency may exacerbate endometriosis symptoms and severity. However, evidence regarding the efficacy of vitamin D supplementation in managing endometriosis symptoms is mixed.One study found that long-term intake of vitamin D-rich foods was associated with an 18% lower risk of developing endometriosis. Additionally, vitamin D deficiency has been correlated with increased expression of mutated KRAS in colorectal cancer patients, suggesting a potential link between vitamin D status and genetic abnormalities in disease progression.Further research is needed to fully understand the relationship between vitamin D deficiency and endometriosis severity, particularly in specific populations like the Thai population. ### Conditions - Endometriosis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Vitamin D level - Vitamin D receptor ### Outcomes Primary Outcomes - Vitamin D level Secondary Outcomes - rASRM - Vitamin D receptor ### Location - Facility: Department of Obstetrics and Gynecology, Faculty of Medicine, Khonkaen University, Khon Kaen, N/A, 40000, Thailand @@
## Correlation Between Muscle Strength and Thickness in Critically Ill Patients - NCT ID: NCT06289244 - Study ID: 6597 - Status: RECRUITING - Start Date: 2023-06-06 - Completion Date: 2025-06-30 - Lead Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico ### Study Description Mechanical ventilation (MV) is associated with adverse outcomes in ventilated patients, and impact of MV-induced diaphragm changes are still unclear.The objective of this prospective observational study is to assess muscle thickness and strength, specifically in limb muscles such as the quadriceps, among critically ill patients who undergo extended mechanical ventilation during their Intensive Care Unit (ICU) stay.The primary inquiries this study seeks to address are:* Is there an association between muscle thickness and strength in the limbs of critically ill patients undergoing prolonged MV?* How much thickness and strength variation can be expected in respiratory and limb muscles in critically ill patients undergoing prolonged MV? ### Conditions - Critical Illness - Muscle Weakness ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Ultrasound - Muscle strength measurement ### Outcomes Primary Outcomes - Correlation between quadriceps strength and thickness Secondary Outcomes - Quadriceps strength - Quadriceps thickness - Diaphragm thickness - Diaphragm strength - Time to reach the sitting position ### Location - Facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, N/A, 20122, Italy @@
## The Use of Artificial Intelligence (AI) for Gait Analysis - NCT ID: NCT06289231 - Study ID: AWFiS/2023_5_PE - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2024-08 - Lead Sponsor: Gdansk University of Physical Education and Sport ### Study Description The main purpose of this study will be to assess the consistency and reliability of measurements made using the Vicon three-plane gait analysis device (Vicon Motion Capture System Ltd, Oxford, UK) and a mobile application based on image recognition technology with the help of artificial intelligence. ### Conditions - Gait ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Gait analysis by the Vicon system - Gait analysis by the mobile image recognition application Secondary Outcomes ### Location - Facility: Gdansk University of Physical Education and Sport, Gdańsk, Pomorskie, 80-336, Poland @@
## Kinesio Taping Versus Interferential Current Therapy in Treating Knee Osteoarthritis - NCT ID: NCT06289218 - Study ID: Treating knee osteoarthritis - Status: NOT_YET_RECRUITING - Start Date: 2024-06-25 - Completion Date: 2025-09 - Lead Sponsor: Cairo University ### Study Description The purpose of this study will be to compare the combined effect of using Kinesio taping versus interferential current with an exercise program on knee pain, function, knee range of motion, knee muscle strength, and functional mobility in chronic knee osteoarthritis. ### Conditions - Knee Osteoarthritis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - interferential current - kinesio taping - exercise ### Outcomes Primary Outcomes - knee flexion range of motion - knee extension range of motion - quadriceps muscle strength - The Western Ontario and McMaster Universities Osteoarthritis Index - Timed up and go test Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## "Comparing Methotrexate Usage Techniques to Prevent Proliferative Vitreoretinopaty After Retinal Detachment Vitrectomy" - NCT ID: NCT06289205 - Study ID: 60/IRB/SLMC/SWL - Status: RECRUITING - Start Date: 2024-03 - Completion Date: 2025-05 - Lead Sponsor: University of Health Sciences Lahore ### Study Description This clinical trial, involving participants with rhegmatogenous retinal detachment, aims to compare Methotrexate Usage Techniques in preventing Proliferative Vitreoretinopathy (PVR) after vitrectomy. The study will evaluate the development of PVR, retinal detachment recurrence, and improvement in visual acuity. Participants will undergo retinal detachment surgery using the vitrectomy technique and will be divided into two groups. One group will receive Methotrexate infusion during surgery, while the other will receive repeated Methotrexate injections post-surgery. The researcher will analyze and compare outcomes between the two groups. ### Conditions - Proliferative Vitreoretinopathy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Methotrexate ### Outcomes Primary Outcomes - Development of Proliferative Vitreoretinopathy (PVR) - Recurrence of Retinal Detachment Secondary Outcomes - Visual Acuity Improvement ### Location - Facility: Sahiwal Medical College & Teaching Hospital, Sahiwal, Pakistan, Sahiwal, Punjab, 57000, Pakistan @@
## Testing C-Raven, a Virtual Tobacco Cessation Intervention, in the Community - NCT ID: NCT06289192 - Study ID: IRB00396489 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2025-06 - Lead Sponsor: Johns Hopkins University ### Study Description To inform a future randomized trial of a virtual counselor led computer delivered intervention for tobacco cessation augmented with community health worker (CHW) support and navigation to lung cancer screening in low-income housing units in Baltimore, the investigators propose to collect data on intervention acceptability and feasibility among individuals in public housing as well as feedback on use of shared decision making when referring for low-dose chest CT (LDCT).The investigators will conduct a feasibility pilot study of a virtual counselor plus community health worker intervention. With a sample of participants from public housing units (N=15), the investigators will collect data on feasibility of recruitment, intervention engagement and completion, and short-term smoking cessation outcomes. Individuals will be assessed at baseline, 1 month and 3 months. At the end of three months, the investigators will conduct follow up interviews with a subset of pilot participants to collect qualitative data on intervention acceptability. Based on this information, the investigators will make iterative improvements to the combined intervention. ### Conditions - Tobacco Dependence ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - C-Raven Virtual Tobacco Cessation Counseling - Nicotine Replacement Product - Community Health Worker - Lung Cancer Screening ### Outcomes Primary Outcomes - Acceptability and Feasibility Secondary Outcomes - Readiness to quit smoking as assessed by The Readiness Ruler - Number of Participants that Uptake nicotine replacement therapy - Continued use of nicotine replacement therapy - Number of quit attempts - Number of participants than maintain cessation - Number of participants that uptake Quit Line services - Participant engagement with community health worker as assessed by number of CHW interactions - Participant satisfaction as assessed by study team survey ### Location - Facility: Chase House Apartments, Baltimore, Maryland, 21201, United States @@
## Thyroid and Cortisol Hormone Response to Sepsis - NCT ID: NCT06289179 - Study ID: Thyroid and cortisol in sepsis - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2026-10-25 - Lead Sponsor: Assiut University ### Study Description Thyroid and cortisol hormone response to sepsis ### Conditions - Sepsis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Pattern of cortisol level and thyroid function response to sepsis in ICU Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Safety and Efficacy of STSP-0601 in Adult Patients With Hemophilia A or B With Inhibitor - NCT ID: NCT06289166 - Study ID: STSP-0601-04 - Status: RECRUITING - Start Date: 2024-03-18 - Completion Date: 2025-02 - Lead Sponsor: Staidson (Beijing) Biopharmaceuticals Co., Ltd ### Study Description This study will assess the safety and efficacy of multiple-dose of STSP-0601 for the treatment of bleeding episodes in hemophilia A or B patients with inhibitor. ### Conditions - Hemophilia ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - STSP-0601 for Injection ### Outcomes Primary Outcomes - Incidence of adverse events - Proportion of successfully treated bleeding episodes Secondary Outcomes - Proportion of successfully treated bleeding episodes - Proportion of bleeding episodes received salvage treatment ### Location - Facility: Anhui Provincial Hospital, Hefei, Anhui, 230000, China @@
## Internal Bracing Following ACL Reconstruction - NCT ID: NCT06289153 - Study ID: 23-01182 - Status: RECRUITING - Start Date: 2024-03-01 - Completion Date: 2025-08-26 - Lead Sponsor: NYU Langone Health ### Study Description The purpose of this study is to assess Anterior Cruciate Ligament (ACL) healing through analyzing clinical, radiographic, functional and patient-reported outcomes following ACL reconstruction with quadriceps graft with and without internal bracing. ### Conditions - ACL Injury ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Arthrex Internal Brace - ACL Reconstruction ### Outcomes Primary Outcomes - Change from Baseline in 2000 International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form at Month 6 Post-Operation - Change from Baseline in 2000 IKDC Subjective Knee Evaluation Form Score at Month 12 Post-Operation - Change from Baseline in Lysholm Knee Scoring System Score at Month 6 Post-Operation - Change from Baseline in Lysholm Knee Scoring System Score at Month 12 Post-Operation - Change from Baseline in Visual Analogue Scale (VAS) - Pain Score at Month 6 Post-Operation - Change from Baseline in Visual Analogue Scale (VAS) - Pain Score at Month 12 Post-Operation Secondary Outcomes ### Location - Facility: NYU Langone Health, New York, New York, 10016, United States @@
## Oral Bioavailability of a New Formulation of Pterostilbene Cocrystal in Comparison With Its Free Form (BIOPTERO2) - NCT ID: NCT06289140 - Study ID: BIOPTERO2 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2024-04 - Lead Sponsor: Fundació Eurecat ### Study Description The goal of this interventional study is to to evaluate the oral bioavailability of the crystallized form of pterostilbene (ccPT) compared to its commercial free base form (pterostilbene (PT) in healthy volunteers. The main question it aims to answer are:• Do the crystallized forms of pterostilbene (ccPT) using two different encapsulation methods exhibit greater bioavailability than its commercial free base form (PT)?Participants will attend to four visits: a preselection visit (V0), a visit for the first postprandial study (V1), a visit for the second postprandial study (V2) after one-week washing period and a visit for the third postprandial study (V3) after another one week washing period.Researchers will analyze the three postprandial assays to determine which type of ccPT encapsulation provides the highest bioavailability compared to the commercial free base form (PT). ### Conditions - Biological Availability ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: OTHER ### Interventions - Pterostilbene cocrystal (ccPT) - Gelatin capsule - Pterostilbene free form (PT) - Pterostilbene cocrystal (ccPT) - Gastro-resistant capsule ### Outcomes Primary Outcomes - Bioavailability of Pterostilbene calculated by area under the curve (AUC 0-24) of plasma pterostilbene levels, both free and total. Secondary Outcomes - Area under the curve (AUC 0-inf) of plasma pterostilbene levels, both free and total. - Relative bioavailability of plasma pterostilbene levels (Frel). - Maximum plasma concentration (Cmax) - Time for maximum plasma concentration (Tmax) - Half-life (T1/2). ### Location - Facility: Fundació Eurecat, Reus, N/A, 43204, Spain @@
## Test Properties of Lower Quarter Y-Balance Test: Effect of Verbal Instructions and Focus Techniques - NCT ID: NCT06289127 - Study ID: GO 22/595 - Status: COMPLETED - Start Date: 2022-07-20 - Completion Date: 2023-11-10 - Lead Sponsor: Hacettepe University ### Study Description The Lower Quadrant Y-Balance Test (LQYBT) is a landmark test used in assessing lower extremity performance, determining risk factors for injury, and making return-to-sport decisions. Studies have shown that the individual's focus of attention affects balance. The literature, has shown that the use of external focus is more effective than the use of internal focus in the execution of a movement.Consistent with these findings, the use of an external focus instruction during the LQYBT may lead to achieve more realistic and a higher performance outcome than the test result with standard instructions. The primary aim of this study was to investigate the effects of using different instructions and focusing techniques on test performance on the LQYBT. The secondary aim was to investigate the reliability of the different instructions and focus tests we used for the LQYBT.Hypothesis of the study that test performance can be further enhanced by differentiating the instructions and focus techniques. A more effective assessment of individual performance may help us to make a more realistic decision to return to sport. ### Conditions - Healthy - Attention Disturbances - Physical Stress ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Lower Quarter Y Balance Test ### Outcomes Primary Outcomes - Investigate the effects of using different instructions and focusing techniques on test performance on the LQYBT. Secondary Outcomes - Investigate the reliability of the different instructions and focus tests we used for the LQYBT. ### Location - Facility: Hacettepe University, Ankara, Sıhhıye, 06430, Turkey @@
## Predictive Utility of a Short-term Improvement in Objectively Measured Physical Activity in Rheumatoid Arthritis (PUSIPA) - NCT ID: NCT06289114 - Study ID: S-20220005 - Status: RECRUITING - Start Date: 2023-09-01 - Completion Date: 2025-09-01 - Lead Sponsor: Hospital of South West Jutland ### Study Description SUMMARY Background: Several studies have shown physical activity (PA) to be inversely correlated to disease activity in rheumatoid arthritis (RA) patients. However, it is unclear whether improved PA leads to lower disease activity or if low disease activity predicts improved PA in rheumatoid arthritis patients. Furthermore, it is unknown how fibromyalgia (FM) affects this interaction.Objective(s): Our primary objective will be to compare the effect of an immediate improvement in physical activity after one week on the proportion of RA patients achieving low disease activity after 12 weeks of biological treatment. Furthermore, we will explore whether the presence of concomitant FM affects this clinical response (i.e., interaction between FM status and PA response).Design: A prospective cohort study in the form of a target-trial attempting to address a causal question comparing the outcome among the participants with an immediate improvement in physical activity, relative to individuals without.Setting and patients: Biologically naive RA patients initiating biological treatment are consecutively enrolled. PA is quantified by accelerometry one week prior to, one week after, and after 3 months of biological treatment.Sample size: 100 RA patients starting biological therapy is planned enrolled in the study.Measurements: RA patients will be divided into two groups depending on their improvement in physical activity after onset of biological treatment. The percentage of time spent in moderate-to-vigorously physical activity (MVPA) i.e., the percentage of time a patient is in motion \[walking, running, bicycling, or swimming\] is measured prior to, one week, and approximately 3 months after biological treatment onset, respectively. The MVPA ratio (MVPA After biological treatment/MVPA Before biological treatment) will divide patients enabling a contrast between two groups: Those with high improvement considering MVPA (after 1 week; the upper tertile of MVPA ratio of the sample) and those without. Treatment response (achieving a disease activity score \< 3.2) after approximately 3 months from baseline will be analyzed as the contrast between groups. ### Conditions - Rheumatoid Arthritis - Fibromyalgia, Secondary - Fatigue - Physical Inactivity ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - MVPA ratio before and after biological therapy - Disease activity score (DAS) Secondary Outcomes - Fibromyalgia - Fatigue ### Location - Facility: Esbjerg Hospital, Esbjerg, N/A, 6700, Denmark @@
## text4FATHER R21: Social Media - Efficacy Trial - NCT ID: NCT06289101 - Study ID: IRB00422008 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2025-06 - Lead Sponsor: Johns Hopkins University ### Study Description This project will be the first to examine the efficacy of a text messaging intervention designed to recruit first-time fathers-to-be using social media across the U.S. to become involved during pregnancy through two months of postnatal age to support infant, mother, and father well-being. ### Conditions - Fathers - Mobile Health - Nuclear Family ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - text4FATHER ### Outcomes Primary Outcomes - Change in Self-efficacy as assessed by the Parenting Sense of Competence Scale (PSOC) - Karitane Parenting Confidence Scale (KPCS) - Fathering Self-Efficacy Scale (FSES) - Father Engagement Scale (FES) - The Co-Parenting Relationship Scale Secondary Outcomes ### Location - Facility: Johns Hopkins Hospital, Baltimore, Maryland, 21287, United States @@
## The Effect of an Individually Adapted Lumbosacral Orthosis on Plantar Pressure and Balance - NCT ID: NCT06289088 - Study ID: E-10840098-772.02-4659 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2024-03-04 - Completion Date: 2024-05-04 - Lead Sponsor: Istanbul Medipol University Hospital ### Study Description The aim of this study is to examine the effect of steel underwire lumbosacral orthosis adapted to the individual by the prosthetist orthotist on pain, comfort, plantar pressure, static and dynamic balance in individuals with low back pain. ### Conditions - Orthosis - Low Back Pain, Postural ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: OTHER ### Interventions - First Intervention - Second Intervention - Third Intervention ### Outcomes Primary Outcomes - Visual Analog scale - Orthosis comfort score - Functional Reach Test (FRT) - Pedobarographic evaluation - Y balance test Secondary Outcomes ### Location - Facility: Istanbul Medipol University, Istanbul, N/A, N/A, Turkey @@
## PrognostICate- Study:Prognostication of ICU- and Ventilator- Days Over the Next Years Until 2040 - NCT ID: NCT06289075 - Study ID: 23-1096-retro - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2024-12-01 - Lead Sponsor: University Hospital of Cologne ### Study Description The Objective of our retrospective multicenter- study is to forecast ICU length of stay (ICULOS) and length of mechanical ventilation (LOMV) in ICU patients of different groups (regarding gender, age group, medical vs surgical admission) worldwide for the next years up to the year of 2040 using statistical forecasting models and historical, national and international ICU databases and population databases. ### Conditions - ICU Admission ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Intensive Care Unit (ICU) treatment ### Outcomes Primary Outcomes - Length of mechanical ventilation - Length of ICU stay Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Neoadjuvant Chemotherapy Plus Camrelizumab for FIGO Stage IB1 Cervical Cancer - NCT ID: NCT06289062 - Study ID: NACI-CERV-005 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2030-12-01 - Lead Sponsor: Tongji Hospital ### Study Description This multicenter, prospective clinical trial is designed to enroll PD-L1 expression-positive patients with stage IB1 cervical cancer who desire fertility preservation to undergo neoadjuvant chemotherapy in combination with a PD-1 inhibitor to evaluate the rate of complete pathologic remission, treatment-related adverse events, pregnancy rate, miscarriage rate, preterm birth rate, live birth rate, PFS and OS. ### Conditions - Cervical Cancer - Neoadjuvant Chemoimmunotherapy - Fertility Preservation ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Camrelizumab - Cisplatin - Nab paclitaxel - biopsy ### Outcomes Primary Outcomes - Pathologic complete response Secondary Outcomes - The negative conversion of HPV - Pregnancy rate - Miscarriage rate - Live birth rate - Preterm birth rate - Adverse Event - Surgical complications - Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Physical Function Score - Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Symptom Specific Scale for Cervical Cancer (EORTC QLQ-CX24) Score - Event-free survival (EFS) - Overall survival (OS) ### Location - Facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, 430030, China @@
## Heavy Strength Training in Head and Neck Cancer Survivors - NCT ID: NCT06289049 - Study ID: HREBA.CC-24-0021 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2026-04 - Lead Sponsor: University of Alberta ### Study Description Despite improvements in treatments, head and neck cancer survivors (HNCS) still endure acute and chronic side effects such as loss of muscular strength, limitations in physical functioning, fatigue, and swallowing difficulties that impact quality of life (QoL) and limit return to work. Light-to-moderate intensity strength training (LMST) has been shown to improve some side effects. Heavy lifting strength training (HLST) may further improve outcomes in some populations, however, only one small pilot study has focused on HNCS. The LIFTING 2 trial will be the first to examine the feasibility and effects of a HLST program versus no exercise in HNCS. ### Conditions - Head and Neck Neoplasms - Head and Neck Cancer - Head and Neck Squamous Cell Carcinoma - Head and Neck Carcinoma ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Experimental ### Outcomes Primary Outcomes - Recruitment rate - Adherence to a heavy lifting strength training program - Completion of maximal strength testing - Followup assessment rate - Safety Secondary Outcomes - Muscular Strength - Cancer Specific Quality of Life - Fear of Cancer Recurrence - Symptom Burden - Perceived Stress - Self-Esteem - Sleep Habits - Malnutrition Status - Swallowing Abilities - Shoulder Range of Motion - Body composition - Handgrip Strength - Physical Function ### Location - Facility: University of Alberta, Edmonton, Alberta, N/A, Canada @@
## Prognosis in Subacute Ischemic Stroke Using Multimodal Imaging - NCT ID: NCT06289036 - Study ID: H2020206632 - Status: COMPLETED - Start Date: 2021-02-01 - Completion Date: 2023-12-31 - Lead Sponsor: The First Hospital of Hebei Medical University ### Study Description We enrolled patients with subacute IS, associated with moderate-to-severe stenosis of the unilateral cervical internal carotid artery, who underwent 4D ASL. Perfusion levels and collateral circulation were compared between groups with favorable prognosis (modified Rankin scale \[mRS\] ≤ 2) and poor prognosis (mRS \> 2). ### Conditions - The Levels of Cerebral Perfusion and Collateral Circulation in Patients With Subacute Stroke ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Modified Rankin Scale（mRS） score after 3 months of onset Secondary Outcomes ### Location - Facility: The First Hospital of Hebei Medical University, Shijia Zhuang, Hebei, N/A, China @@
## HA-WBRT-SIB for Brain Metastasis of Lung Cancer - NCT ID: NCT06289023 - Study ID: NCC1278 - Status: COMPLETED - Start Date: 2016-01-01 - Completion Date: 2022-12-31 - Lead Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences ### Study Description Patients with lung cancer and brain metastases undergo HA-WBRT-SIB using image-guided radiotherapy, receiving a total dose of 30-36 Gy delivered in 18-20 fractions to the whole brain (CTV), while the dose to the GTV is boosted to 44 Gy-52 Gy in 18-20 fractions, ﬁve times a week. The optimal mean dose (Dmean) to the bilateral hippocampus should optimally be ≤ 8 Gy, with a mandatory maximum dose (Dmax) to the hippocampus not exceeding 10 Gy; the preferred Dmean to the hippocampus PRV should optimally be ≤ 9 Gy, while the mandatory Dmax to the hippocampus PRV should be ≤ 12 Gy. The HVLT-R immediate recall scores are obtained at baseline and 1, 3, and 6 months after treatment. ### Conditions - Lung Neoplasm - Brain Metastases - Simultaneous Integrated Boost - Hippocampal Avoidance - Cognitive Function ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - HA-WBRT-SIB ### Outcomes Primary Outcomes - OS Secondary Outcomes - PFS - iPFS - HVLT-R learning score ### Location - Facility: National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciecnces and Peking Union Medical College, Beijing, Beijing, N/A, China @@
## Neural Mechanisms of Family-Focused Treatment for Youth Depression - NCT ID: NCT06289010 - Study ID: 7354E - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2027-11 - Lead Sponsor: Boston University Charles River Campus ### Study Description The goal of this interventional study is to compare the baseline neural mechanisms and parenting in depressed and non-depressed children and to examine baseline neural mechanisms and parenting as predictors of Family-Focused Treatment for Childhood-Depression (FFT-CD) outcomes. The main questions it aims to answer are:* What are differences between depressed and non-depressed participants on baseline neural and parenting indicators?* Do baseline neural and parenting indicators predict response to FFT-CD?* Does change in parenting and neural functioning mediate change in depression from baseline to follow-up?Participants will:* complete baseline clinical measures* complete neuroimaging tasks via Functional Magnetic Resonance Imaging (fMR)* undergo a 12-session course of FFT-CD* complete follow up evaluations and neuroimaging ### Conditions - Childhood Depression ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Family-Focused Treatment for Childhood-Depression (FFT-CD) ### Outcomes Primary Outcomes - Depression Treatment Response - Children's Self Report of Depressive Symptoms Secondary Outcomes - Depression Remission ### Location - Facility: Boston University, Boston, Massachusetts, 02215, United States @@
## tACS Intervention for Methamphetamine Addiction - NCT ID: NCT06288997 - Study ID: TFYuan_tACS - Status: COMPLETED - Start Date: 2021-11-21 - Completion Date: 2023-11-09 - Lead Sponsor: Shanghai Mental Health Center ### Study Description A growing body of evidence suggests a wide range of brain areas are critical for regulating cognitive control over decisions and involving in drug related cue processing. Previous studies have demonstrated that transcranial alternating current stimulation (tACS) over prefrontal cortex reduces craving for meth dependences. In this study, the investigators investigated whether a current level of 15mA with a patented frequency of 77.5Hz tACS intervention of prefrontal cortex cortices in methamphetamine addiction could reduce the subjective craving and improve the cognitive abilities. ### Conditions - Methamphetamine-dependence ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - transcranial alternating current stimulation - sham tACS ### Outcomes Primary Outcomes - Changes of Cue-induced craving Secondary Outcomes - Changes of cognition: behavioral inhibition - Changes of cognition: choice under ambiguity - changes of neural mechanism - Changes of depression status - Changes of anxiety status - Changes of sleep status - Changes of impulsivity - event-related potential in passive viewing task ### Location - Facility: Beijing Tiantanghe Addiction Rehab Center, Beijing, Beijing, 100054, China @@
## Effects of rTMS on Respiratory Function and Gut Microbiota in Patients With Brain Injury - NCT ID: NCT06288984 - Study ID: NFEC-2024-061 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2026-12-31 - Lead Sponsor: Nanfang Hospital, Southern Medical University ### Study Description Impaired respiratory function may occur after brain injury, and will progress to restricted respiratory dysfunction without early intervention. At present, there is a lack of effective treatment options for respiratory dysfunction. Repetitive Transcranial Magnetic Stimulation(rTMS) is a non-invasive, painless and non-invasive neuroregulatory technique. In healthy people, rTMS applied to the respiratory motor cortex induces a contralateral respiratory muscle response. However, whether rTMS can improve respiratory function in patients with brain injury remains unclear. gut microbiota can affect muscle function and mass, and animal experiments have shown that probiotics can increase skeletal muscle mass and grip strength in mice. On the other hand, studies have found that rTMS can improve the nutritional status of patients with vegetative state by regulating the structure of gut microbiota. However, it remains unclear whether rTMS can improve respiratory muscle function in patients with brain injury by regulating gut microbiota. Therefore, the investigators intend to apply rTMS to the respiratory motor cortex to observe whether rTMS can improve respiratory function and reduce the incidence of pneumonia in patients with brain injury, and to observe the role of gut microbiota in this process. ### Conditions - Brain Injuries - Respiratory Function Impaired - Gut Microbiota ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - active rTMS - sham rTMS ### Outcomes Primary Outcomes - Diaphragm thickness - Thickening fraction Secondary Outcomes - Diaphragm mobility - Surface EMG of diaphragm - Forced vital capacity(FVC) - Forced expiratory volume at one second（FEV1） - Peak expiratory flow (PEF) - Maximum voluntary ventilation (MVV) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Personalized Innovative Intervention Pathways to Promote EF in Children With CP - NCT ID: NCT06288971 - Study ID: IRCCS FSM - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2027-03-01 - Lead Sponsor: IRCCS Fondazione Stella Maris ### Study Description Cerebral palsy (CP) is an umbrella term, covering a group of disorders of movement and posture. It is now accepted that CP represents much more than a disorder of movements considering the frequent association with a broad range of impairments, including cognitive impairments. In general, multiple clinical characteristics that define and determine different functional profiles. Several studies on children with unilateral and bilateral CP have been shown that, despite the overall preserved intellectual functioning, there are specific neuropsychological impairments distinguishing the two forms, including deficits in different Executive Functions (EF) components. Executive Functions (EFs) represent a complex cognitive domain consisting of a set of top-down functions essential for adaptive goal-directed behaviour, allowing to formulate, plan, and organise ideas, cope with challenges and novelties, resist temptations and stay focused. EF represents general domain abilities transversal to several cognitive processes and underling different daily life activities and school learning skills. Empowering EF becomes therefore crucial in children with CP both to strengthen specific functional EF weaknesses and to achieve far transfer effects on other compromised domains, such as motor planning, academic skills,and/or visuospatial processing. To pursue this, the EF training needs to be integrated into the complex and multidisciplinary care context promoting innovative intervention methodologies based on scientific evidence. Recent researches and clinical practice, carried out in our Institute, supports the effectiveness of innovative interventions on EF using new technologies in typical and atypical development, such as Self-adapting web based softwares, Game-based tools or Educational Robotics. Literature suggests these technologies allow to promote timely intervention within a user-friendly context, while respecting the key criteria of evidence-based neuropsychological rehabilitation, both reducing hospitalisation times and supporting interest and motivation for participation. The primary aim of this study is to evaluate the applicability of technological intervention integrated with psychomotor activities to promote EF and then secondary to measure the effect on the functional profile of children with CP, including motor planning, visuo-spatial processing and learning skills, evaluating both short-term (T2) and long-term changes (T3). ### Conditions - Executive Functions in Cerebral Palsy ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Self-adaption web-based software for the rehabilitation of EF and visuo-spatial abilities - Tele-rehabilitation of EF and specific cognitive processes underlying academic skills - Game-based tools for the rehabilitation of EF and motor planning ### Outcomes Primary Outcomes - changes in score of inhibition subtest at the NEPSY-II Secondary Outcomes - changes in score of the sustained attention subtest at the Leiter-3 - changes in score of Developmental Test of Visual-Motor Integration (VMI) - changes in score of MOXO-continuous performance test - changes in score of Corsi block-tapping subtest at the BVS-corsi - changes in score of Behaviour Rating Inventory of Executive Function (BRIEF-P/2) for parents - changes in score of RAN (rapid automatized naming) subtest at the rapid automatized naming and visual search of colours, figures and numbers test. - changes in score of reading and text comprehension task at the ALCE - changes in score of reading and writing task at the DDE-2 - changes in score of digit span forwards and backwards subtest at the BVN 5-11 and BVN 12-18 - changes in score of Go/No-Go and N-back 1 subtest at the teleFE - changes in score of verbal fluency subtest at the NEPSY-II - changes in score of Test of Visual Perception and Visuo-motor Integration (TPV) - changes in score of Praxic and Motor Coordination Skills-2nd Edition (APCM-2) - changes in score of Movement Assessment Battery for Children - Second Edition (Movement ABC-2) - changes in score of Synthetic scale for the evaluation of writing in developmental age (BHK test) ### Location - Facility: IRCCS Fondazione Stella Maris, Pisa, N/A, 56128, Italy @@
## Quality of Life in Children With Cerebral Palsy - NCT ID: NCT06288958 - Study ID: Fondazione Stella Maris - Status: COMPLETED - Start Date: 2019-04-01 - Completion Date: 2021-12-31 - Lead Sponsor: IRCCS Fondazione Stella Maris ### Study Description Cerebral Palsy (CP) is an umbrella term that defines a group of permanent disorders of movement and posture, happening during the developing foetal or infant brain. In addition to the main motor symptoms, other clinical disturbances are associated. CP represents a clinical condition with an impact in Quality Of Life (QOL) and social participation, as reported in different countries. QOL is a multidimensional construct defined as "an individual's perception of their position in life in the context of the culture and value systems in which they live and in relation to their goals, expectations, standards, and concerns" (WHOQOL, 1998).In order to best capture the peculiarities of CP, specific questionnaires were carried out to analyse the QOL in this clinical population. The Cerebral Palsy Quality of Life Questionnaire for Children (CP QOL-Child) is an internationally recognized CP-specific instrument based on the International Classification of Functioning, Disability and Health (ICF) framework. Many studies have used this instrument, showing a lower QOL in children with CP compared to their typical developing peers. In literature, several studies have shown that children with CP are at risk of experiencing activity limitations and participation restriction and which can potentially affect their QOL. Participation in daily-life activities, defined as a person's "involvement in a life situation," and participation restriction, characterised as "problems an individual may experience in involvement in life situations" (ICF, World Health Organization, 2001). Studies aimed at describing participation in daily-life activities in CP have consistently found lower frequencies and fewer activities in children and adolescents with CP. In order to gain an overall picture of the QOL and participation of children and adolescents with CP, several studies underline the importance of analysing other background factors, such as motor and cognitive functioning, pain perception, and individual characteristics.The present study aims to deeper understand the perception of QOL and social participation in a group of Italian children with CP, as reported by their parents, using two commonly used questionnaires in the CP population (CP-QOL and PEM-CY). In addition, this study aims to explore the roles of specific clinical variables, such as motor function and cognitive level, on parental perceptions of QOL, in the development of QOL and participation. ### Conditions - Unilateral and Bilateral Cerebral Palsy ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Quality of Life and social participation in Italian children with CP ### Outcomes Primary Outcomes - Score of CP-QOL Child questionnaire Secondary Outcomes - Score of PEM-CY questionnaire - Scores of Wechsler Intelligence scales ### Location - Facility: IRCCS Fondazione Stella Maris, Pisa, N/A, 56128, Italy @@
## Effect of an Educational Program on Health-related Outcomes of Patients With Dry Eye Syndrome - NCT ID: NCT06288945 - Study ID: Dry eye syndrome - Status: COMPLETED - Start Date: 2023-01-15 - Completion Date: 2023-09-14 - Lead Sponsor: Alexandria University ### Study Description Dry eye syndrome (DES) is a widespread ocular disease affecting the general population. It is a complex disorder affecting the surface of the eye, marked by an imbalance in the tear film and ocular symptoms. Therefore this study was done to determine the effect of an educational program on health-related outcomes of patients with DES including the severity of symptoms related to DES and their influence on visual-related functions ### Conditions - Dry Eye Syndrome ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Educational Program ### Outcomes Primary Outcomes - ocular irritation symptoms associated with Dry eye syndrome and their effect on functions related to vision Secondary Outcomes ### Location - Facility: Faculty of Nursing, Alexandria university, Alexandria, N/A, N/A, Egypt @@
## Outcome Study of Conventional Steroids vs. Steroids Combined With Mycopehnolate in Newly Diagnosed Immune Thrombocytopenia Purpura. - NCT ID: NCT06288932 - Study ID: NIBD/IRB-263/08-2023 - Status: RECRUITING - Start Date: 2024-02 - Completion Date: 2025-01 - Lead Sponsor: National Institute of Blood and Marrow Transplant (NIBMT), Pakistan ### Study Description Immune thrombocytopenia Purpura (ITP) is an autoimmune condition delineated by humoral as well as cell mediated immune response against thrombocyte surface proteins GPIIb/IIIa receptors, affecting primary homeostasis leading to mucocutaneous bleeding.ITP is characterized by platelet count \<100 x 109/L. The conventional line of treatment for newly diagnosed ITP is steroids but significant disadvantages have been associated with long term use and a high risk of relapse when reducing the dose. The addition of MMF to the first line treatment of ITP resulted in substantial response and a lower risk of refractory ITP with decreased financial burden and improved outcome. ### Conditions - Immune Thrombocytopenia Purpura ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Mycophenolate Mofetil (MMF) Treatment ### Outcomes Primary Outcomes - Platelet count monitoring Secondary Outcomes - Assessment of Health-Related Quality of Life questionnaire - Incidence of adverse events ### Location - Facility: National Institute of Blood Diseases and Bone Marrow Transplantation, Karachi, Sindh, 75300, Pakistan @@
## Erythritol vs Ultrasonic Scaler Prophylaxis Systems on Dental Implants With Crowns Made by Different Materials - NCT ID: NCT06288919 - Study ID: 2023-IMPLHYGIENE - Status: ENROLLING_BY_INVITATION - Start Date: 2024-03-01 - Completion Date: 2026-04-10 - Lead Sponsor: University of Pavia ### Study Description The aim of the study is to assess which prophylaxis methods is the most suitable for peri-implant hygiene between erythritol and ultrasonic scaler with peek inserts.A randomized clinical trial will be conducted on the patient. Patients will be randomly divided into two groups:* Erythritol group: erythritol with a particle size of \~14 µm will be used for 5 seconds (AIRFLOW® PLUS EMS)* Ultrasonic scaler group: a piezoelectric handpiece with peek inserts (Mini Piezon EMS; PI EMS) will be used.Different subgroups will be defined according to the material of the dental crown of the related implant.The oral hygiene session will be carried out every 6 months (2-years follow-up; 6 sessions), after instruction and motivation of the patient, completion of the clinical chart with the recording of the Probing Depth (evaluation in mm of the peri-implant sulcus taken by a periodontal probe; 4 surfaces of the gingival margin are detected: vestibular, palatal/lingual, mesial, distal), Bleeding on Probing and Plaque Index. ### Conditions - Dental Implant Failed - Peri-implant Mucositis - Peri-Implantitis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Erythritol prophylactic powders - Ultrasonic scaler with peek inserts ### Outcomes Primary Outcomes - Probing Depth (PD) - Bleeding on Probing (BoP) - Plaque Index Secondary Outcomes ### Location - Facility: Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia, Pavia, Lombardy, 27100, Italy @@
## Acute and Subacute Iliofemoral and/or Caval Deep Vein Thrombosis: Evaluation of Mechanical Thrombectomy Systems - NCT ID: NCT06288906 - Study ID: ASTER Study - Status: NOT_YET_RECRUITING - Start Date: 2024-03-30 - Completion Date: 2027-12 - Lead Sponsor: IRCCS San Raffaele ### Study Description This is a physician-initiated, observational, monocentric, retrospective and prospective Study. The study is intended to assess the feasibility of mechanical thrombectomy of caval and iliofemoral veins according to normal clinical practice in adult patients with symptomatic acute or subacute ileofemoral or caval deep vein thrombosis objectively diagnosed with CT scan imaging. ### Conditions - Thrombosis, Venous ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - mechanical thrombectomy of caval and iliofemoral veins ### Outcomes Primary Outcomes - Rate of Technical success - Number of Participants presenting Bleeding Secondary Outcomes ### Location - Facility: San Raffaele Hospital, Milano, N/A, 20132, Italy @@
## SHEN211 Tablets for the Treatment of Mild and Moderate Novel Corona Virus Infections (COVID-19) - NCT ID: NCT06288893 - Study ID: DEU-2001 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2025-01-01 - Lead Sponsor: JKT Biopharma Co., Ltd. ### Study Description Randomized, double-blind, placebo-controlled, multicenter phase II clinical study of SHEN211 tablets ### Conditions - COVID-19 ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - SHEN211 Tablets - Placebo for SHEN211 Tablets ### Outcomes Primary Outcomes - Change from baseline in SARS-CoV-2 viral load at each time point Secondary Outcomes - Time of recovery - Time to response - Time to negative - Percentage of subjects with disappearance of clinical symptoms - Change in COVID-19 symptom score - Ct value change from baseline - Change from baseline in chest CT scan (optional) - Percentage of Subjects Progressed - Percent of Subjects Who Died - Safety Assessment Results ### Location - Facility: Shenzhen Third People 's Hospital, Shenzhen, Guangdong, 518112, China @@
## Impact of Earthquake Trauma on Nurses' Compassion Fatigue: A Study From Kahramanmaraş, Turkey - NCT ID: NCT06288880 - Study ID: kilis_4 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2024-05-01 - Lead Sponsor: Kilis 7 Aralik University ### Study Description This study investigates the impact of earthquake trauma on compassion fatigue among nurses working in emergency services following the devastating earthquakes on 6 February 2023, in Kahramanmaraş, Turkey. These earthquakes, with magnitudes of approximately 7.7 and 7.6, affected 11 provinces and resulted in over 50,000 deaths and 100,000 injuries, placing emergency service nurses at the forefront of dealing with the aftermath and trauma. The concept of compassion fatigue, characterised by a reduced capacity for empathy after repeated exposure to traumatic events, is a significant concern for nurses who have been directly involved in the care of earthquake victims. This study aims to explore the extent of earthquake trauma and compassion fatigue among these nurses, examining the relationship between these two conditions and their long-term effects. Given the limited research on post-traumatic stress disorder and compassion fatigue among emergency service nurses, this study seeks to contribute valuable insights into the psychological impacts of disaster response on healthcare professionals. The hypotheses tested aim to better understand the risks and psychological burdens faced by nurses in the wake of such natural disasters. ### Conditions - Earthquake - Compassion Fatigue ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Section 1: Demographic Information Form - Section 2: Post-Earthquake Trauma Level Determination Scale - Section 3: Compassion Fatigue Short Scale Secondary Outcomes ### Location - Facility: Islam Elagöz, Kilis, N/A, 79100, Turkey @@
## A 12 Months Prospective Study Comparing Functional Outcome Scores in Hip Arthroscopic Labral Repair Versus Debridement - NCT ID: NCT06288867 - Study ID: FMASU MD28/2024 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2025-12-01 - Lead Sponsor: Ain Shams University ### Study Description This study aims to address hip labral tears and compare between arthroscopic labral repair versus debridement. ### Conditions - Hip Injuries - Acetabular Labral Tear - Femoro Acetabular Impingement ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Arthroscopic Labral Repair - Arthroscopic Labral Debridement ### Outcomes Primary Outcomes - Change from baseline in Hip Function, as measured by Hip Outcome Score (HOS) - Change from baseline in Hip Function, as measured by Harris Hip Score (HHS) - Change from baseline in Pain, as measured by the Visual Analogue Scale (VAS) Secondary Outcomes ### Location - Facility: Ain Shams University, Cairo, N/A, N/A, Egypt @@
## Efficacy of Olanzapine on Weight Gain in Advanced Gynecologic Cancer With Paclitaxel and Carboplatin: a Double Blind, Placebo-controlled Randomized Trial - NCT ID: NCT06288854 - Study ID: 66222 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-03 - Completion Date: 2025-06-30 - Lead Sponsor: Rajavithi Hospital ### Study Description * Efficacy of olanzapine on weight gain in advanced stage gynecologic cancer* Proprotion of pateints in advanced stage gynecologic cancer who recieving paclitaxel and carboplatin chemotherapy gain weight on olanzapine or placebo ### Conditions - Weight Gain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - weight gain each group ### Outcomes Primary Outcomes - Efficacy of olanzapine on weight gain in advanzed stage gynecologic cancer recieving paclitexal and carboplatin chemotherapy Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Efficacy and Safety of Liposomal Bupivacaine Under ERAS Concept for Postoperative Analgesia of Ultrasound-Guided QLB in Gynecologic Laparoscopic Patients: A Randomized, Single-blind, Active-Controlled Clinical Study - NCT ID: NCT06288841 - Study ID: TJMZ2023-008 - Status: RECRUITING - Start Date: 2023-11-30 - Completion Date: 2024-11-29 - Lead Sponsor: Tianjin Medical University General Hospital ### Study Description With the development of the concept of comfortable medicine and enhanced recovery surgery (ERAS), optimizing the perioperative management of patients, reducing surgical stress, and reducing postoperative pain can effectively reduce perioperative complications and achieve the purpose of accelerating recovery. As an important part of ERAS, multimodal analgesia is the core concept of perioperative analgesia management. As a kind of perioperative multimodal analgesia, quadratus lumbar muscle block (QLB) is a type of local anesthetic drug injected around the quadratus lumbar muscle to reduce or eliminate abdominal wall pain and visceral pain after abdominal surgery. QLB has been used successfully for pain control after laparoscopic and open surgery, reducing perioperative opioid use and improving prognosis-related measures such as PONV and length of hospital stay. Bupivacaine liposomes use DepoFoam technology to encapsulate the drug in polycystic liposomes, which can prolong the release time of bupivacaine due to the different rupture times of different vesicles, and the postoperative analgesia can be up to 72 hours. In this project, patients who undergo elective laparoscopic uterine and double adnexectomy were selected to be injected with lipososomes of bupivacaine at different concentrations under ultrasound guidance of bilateral posterior QLB before anesthesia induction, and the effect of liposomal bupivacaine on postoperative pain was investigated by evaluating the postoperative pain and incidence of adverse events. This study will greatly promote the clinical promotion and application of bupivacaine liposome, improve the postoperative comfort and satisfaction of patients, and accelerate the postoperative recovery of patients. ### Conditions - Pharmacological Action ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Ropivacaine injection - Bupivacaine liposome ### Outcomes Primary Outcomes - NRS pain score within 72 hours after surgery Secondary Outcomes ### Location - Facility: Tianjin Medical University General Hospital, Tianjin, Tianjin, 300052, China @@
## The Efficacy of Aerobic Exercise Training on Autonomic Nervous System and Endothelial Function in Patients With Compensated Cirrhosis - NCT ID: NCT06288828 - Study ID: IRB0569/66 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-05 - Completion Date: 2025-12-31 - Lead Sponsor: King Chulalongkorn Memorial Hospital ### Study Description The goal of this clinical trial is to explore the impact of a 16-week aerobic exercise regimen on the autonomic nervous system and endothelial function in patients with compensated cirrhosis who maintain sedentary lifestyles. The primary research question is:1) What effect does 16 weeks of aerobic exercise have on changes in the autonomic nervous system and endothelial function in cirrhotic patients?Additionally, the secondary research questions are:1. How does a 16-week aerobic exercise program influence changes in muscle mass, muscle strength, and physical performance in cirrhotic patients?2. Is there a correlation between muscle mass and parameters of the autonomic nervous system in cirrhotic patients?Participants in the intervention group will undergo 150 minutes of moderate aerobic exercise per week for 16 weeks, accompanied by a personalized nutritional plan (1.2 grams of protein per kilogram of ideal body weight per day and a calorie intake of 35 kilocalories per kilogram of ideal body weight per day). The control group will solely receive nutritional guidance and maintain their sedentary lifestyle. The researchers will compare outcomes between these two groups. ### Conditions - Cirrhosis - Aerobic Exercises - Lifestyle Modification - Endothelial Function - Autonomic Nervous System - Autonomic Dysfunction - Heart Rate Variability - Flow Mediated Dilation - Sarcopenia - Physical Activity - Physical Functional Performance ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Aerobic exercise - Nutrition consultant ### Outcomes Primary Outcomes - Autonomic function test: Heart rate variability (HRV) - Endothelial function test: Flow mediated dilation (FMD) in % FMD change Secondary Outcomes - Physical function - Muscle mass change - Muscle strength change ### Location - Facility: Faculty of medicine, King Chulalongkorn Memorial Hospital, Bangkok, N/A, 10330, Thailand @@
## Oral Fluid vs IV Fluid After Primary TKA - NCT ID: NCT06288815 - Study ID: TUH oral fluid TKA - Status: RECRUITING - Start Date: 2024-01-10 - Completion Date: 2025-06 - Lead Sponsor: Thammasat University Hospital ### Study Description The goal of this study is to compared efficacy of oral fluid and intravenous fluid after primary unilateral total knee arthroplasty.The main question it aims to answer is:Does oral fluid replacement after primary unilateral total knee arthroplasty provide a patient recover faster than intravenous fluids replacement? ### Conditions - Osteoarthritis, Knee - Total Knee Arthroplasty - Oral Fluid Replacement ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Oral fluid - IV fluid ### Outcomes Primary Outcomes - Time to stand and walk Secondary Outcomes - Time up and go - Incidence of oliguria - Incidence of nausea/vomiting - Urine specific gravity - the levels of certain electrolytes - the levels of creatinine - the levels of blood urea nitrogen (BUN). - Complications ### Location - Facility: Thammasat University, Khlong Luang, Pathum Thani, 12120, Thailand @@
## Study of Wilms Tumors Among Patients of Shefa Al-Orman Children Cancer Hospital - NCT ID: NCT06288802 - Study ID: 04-2023-200647 - Status: RECRUITING - Start Date: 2020-06-15 - Completion Date: 2024-12 - Lead Sponsor: South Egypt Cancer Institute ### Study Description The goal of this cross sectional observational study is to determine the percentage of Wilms tumors among pediatric cancers at Shefa Al-Orman Children Cancer Hospital from june 2020 to june 2024,to study the outcome of patients with Wilms tumor treated according to SIOP Umbrella protocol during the study period and to study the treatment related complications during therapy according to common terminology criteria of adverse events version 5.0 (CTCAE Version 5.0). ### Conditions - Wilms Tumor ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Overall-survival (OS) Secondary Outcomes - Event-free survival (EFS) ### Location - Facility: Shefa Al-orman Children Cancer Hospital, Luxor, N/A, N/A, Egypt @@
## Turkish Validity and Reliability of the Social Frailty Index - NCT ID: NCT06288789 - Study ID: SFI-TR - Status: COMPLETED - Start Date: 2024-02-25 - Completion Date: 2024-03-30 - Lead Sponsor: Pamukkale University ### Study Description The aim was to examine the validity and reliability of the Social Frailty Index in Turkish among older adults. 65 years and above older adults will be included included in the study. Older adults who agree to participate in the study will first be administered the Hodkinson Mental Test. Those who score 6 points and above will be included in the study. To evaluate the validity of the \"Social Frailty Index\", Social Inclusion Scale, Older people\'s quality of life-brief (OPQOL-brief) and Lubben Social Network Scale will be applied to the participants. To determine the reliability of the \"Social Frailty Index\", older adults who do not receive any treatment will be tested and re-tested at one-week intervals. ### Conditions - Elderly - Frailty - Quality of Life ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - Social Frailty Index ### Outcomes Primary Outcomes - Social Frailty Index Secondary Outcomes - Socıal Inclusıon Scale - Older people's quality of life-brief (OPQOL-brief) - Lubben Social Network Scale ### Location - Facility: Elif Gur Kabul, Usak, Merkez, 64200, Turkey @@
## Efficacy of Azadirachta Indica Based Herbal Mouthwash in Treating the Tooth Hypersensitivity - NCT ID: NCT06288776 - Study ID: SOD/ERB/2023/22-04 - Status: COMPLETED - Start Date: 2023-02-01 - Completion Date: 2023-04-30 - Lead Sponsor: Pakistan Institute of Medical Sciences ### Study Description Type of study: Single-blinded clinical trial to evaluate the effectiveness of Azadirachta indica based Herbal mouthwash to treat the tooth sensitivity in patients.Participants aged 20 years and above having Gingival Index score 3 will be included in the study. Their tooth sensitivity will be checked initially and then they will be given Herbal based mouthwash for 3 months. Again, their tooth sensitivity shall be checked after 3 months. ### Conditions - Tooth Sensitivity ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Herbal based mouthwash ### Outcomes Primary Outcomes - Toothsensitivity declination with herbal based mouthwash Secondary Outcomes ### Location - Facility: Afsheen Mansoor, Islamabad, N/A, 44080, Pakistan @@
## Nerve Transfer to Improve Function in High Level Tetraplegia - NCT ID: NCT06288763 - Study ID: SC220192 - Status: RECRUITING - Start Date: 2024-02-05 - Completion Date: 2028-12-31 - Lead Sponsor: Washington University School of Medicine ### Study Description The goal of this observational study is to determine if nerve transfer surgeries improve upper extremity function and quality of life in patients with a high level cervical spinal cord injury.Participants will:* undergo standard of care pre- and post-op testing and study exams* complete pre- and post-questionnaires* undergo standard of care nerve transfer surgeries* follow-up with surgeon at 6/12/18/24/36 and potentially at 48 months* attend therapy at local therapist for up to 2 years postop. ### Conditions - Cervical Spinal Cord Injury - Tetraplegia ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Elbow Dynamometry - Spinal Cord Independence Measure - Motor strength in medical research council grade (MRC) - Electrodiagnosis (Nerve Conduction Study and Electromyography Secondary Outcomes - Canadian Outcomes Performance Measure (COPM) - Capabilities of Upper Extremity Questionnaire (CUE-Q) - Modified Ashworth Scale (MAS) - Spinal Cord Injury Quality of LIfe Questionnaire - International SCI Pain Basic Dataset (ISCIPBDS) ### Location - Facility: Stanford University, Stanford, California, 94305, United States @@
## Protective Effect of Indocyanine Green Fluorescence Imaging Technology on Parathyroid Glands During Total Thyroidectomy - NCT ID: NCT06288750 - Study ID: sdllycyyqx001 - Status: RECRUITING - Start Date: 2024-02-01 - Completion Date: 2025-06-30 - Lead Sponsor: Shandong Linglong Yingcheng Hospital ### Study Description Accurate identification and evaluation of the parathyroid glands (PGs) intraoperatively is critical to reduce the incidence of postoperative hypoparathyroidism after total thyroidectomy. Near-infrared fluorescence imaging (NIFI), including the autofluorescence (AF) and indocyanine green fluorescence (ICGF) imaging, is a promising technique to protect PGs. This study aimed to assess whether the combined use of AF and ICGF could reduce the incidence of postoperative hypoparathyroidism and improve the identification and evaluation of PGs during total thyroidectomy. ### Conditions - Total Thyroidectomy - Parathyroid Function Low Adverse Event - Parathyroid Glands--Diseases - Indocyanine Green ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: PREVENTION ### Interventions - Indocyanine Green - No indocyanine green ### Outcomes Primary Outcomes - Identification of parathyroid glands (PGs) by NIR/ICG camera detected high-contrast Secondary Outcomes - Central lymph node dissetion (CLND) ### Location - Facility: Shandong Linglong Yingcheng Hospital, Yantai, Shandong, 264000, China @@
## Assessing Patient Engagement in Keratoconus Clinical Research - NCT ID: NCT06288737 - Study ID: 54335073 - Status: NOT_YET_RECRUITING - Start Date: 2025-03 - Completion Date: 2027-03 - Lead Sponsor: Power Life Sciences Inc. ### Study Description This study aims to investigate the influences behind patient choices regarding involvement, discontinuation, or re-engagement in keratoconus clinical trials. Uncovering these factors is essential to enhance the relevance and efficacy of future research endeavors.In essence, this trial aims to deepen understanding of the factors influencing participation in keratoconus clinical trials. Elevating participation rates could expedite the development of innovative treatments for this challenging condition. ### Conditions - Keratoconus ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Rate of patients who decide to join in a keratoconus clinical trial - Number of keratoconus patients who remain in clinical trial until completion Secondary Outcomes ### Location - Facility: Power Life Sciences, San Francisco, California, 94107, United States @@
## MOdifiable facTors to Improve VentilAtion ThErapy in ICU - NCT ID: NCT06288724 - Study ID: NatIntensive - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2024-09 - Lead Sponsor: Nat Intensive Care Surveillance - MORU ### Study Description ABSTRACT Introduction: Invasively ventilated patients in low and middle-income countries (LMICs) experience significantly higher mortality compared to those in High income countries (HICs). Direct application of HIC strategies to LMICs maybe ineffective due to context-specific challenges. This study aims to leverage the Intensive Care Registry of Uganda (ICRU) to identify ICU structural and process-related modifiable factors that impact patient outcomes in a low income country.Methods: The MOTIVATE-ICU is a prospective multicentre observational study in invasively ventilated patients. It involves a registry-embedded component examining patient- and process-related factors and a cross-sectional survey on ICU organizational structures. Inclusion criteria encompass patients aged ≥ 15 years undergoing IMV in Ugandan ICUs. Primary outcomes are ICU mortality, ICU length of stay (LOS), and duration of ventilation. Secondary outcomes include ventilator-associated complications, non-pulmonary organ support. tTracheostomy outcomes will be explored in a pre-planned substudy. Factors potentially associated with outcomes will be categorized into two groups; non-modifiable factors and potentially modifiable. Non-modifiable factors will include patient-related factors like age, comorbidities and illness severity; potentially modifiable factors include processes of care (e.g. sedation levels) and ICU organizational structure (e.g. staffing patterns). Multilevel multivariable logistic regression will be utilized to study associations, with both patient and ICU level fixed effects considered.Ethics and Dissemination: Given its observational nature, this study seeks a waiver for patient individual informed consent. Data anonymization ensures patient privacy. Following the principles of the Declaration of Helsinki, relevant ethical approvals will be acquired. Study findings will be disseminated through conferences and peer-reviewed journals. ### Conditions - Critical Illness - Invasive Mechanical Ventilation - ICU Mortality - Developing Countries - Risk Factors ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - ICU mortality - ICU Length of Stay - Duration of mechanical ventilation Secondary Outcomes - Duration of non-pulmonary organ support - ICU-Free days - Ventilator-free days - Ventilator-associated Pneumonia - Tracheobronchitis - Non-infectious Pulmonary complication - Readmission - Unplanned extubations - Tracheostomy related outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Novel Telemedicine-Delivered Prolonged Exposure Therapy for Treating PTSD in Individuals With OUD - NCT ID: NCT06288711 - Study ID: CHRBSS #STUDY00002538 - Status: RECRUITING - Start Date: 2024-04-30 - Completion Date: 2027-11-30 - Lead Sponsor: University of Vermont ### Study Description Among individuals with opioid use disorder (OUD), posttraumatic stress disorder (PTSD) presents a significant clinical challenge. The prevalence of PTSD is substantially higher in individuals with OUD than in the general population, with nearly 90% reporting lifetime trauma exposure and 33% meeting diagnostic criteria for PTSD. The primary objective of this study is to evaluate the efficacy of a novel telemedicine-delivered prolonged exposure therapy protocol for improving PE attendance and reducing PTSD symptom severity in individuals with concurrent PTSD and OUD. ### Conditions - Opioid Use Disorder - Posttraumatic Stress Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Prolonged exposure therapy - Financial incentives - Treatment as usual ### Outcomes Primary Outcomes - Prolonged exposure therapy session attendance - Prolonged exposure therapy completion - Change in posttraumatic stress disorder symptom severity - clinician rated Secondary Outcomes - Change in non-prescribed drug use - objective - Change in non-prescribed drug use - self-reported - Change in opioid craving - Medications for opioid use disorder treatment retention - Prolonged exposure therapy acceptability - Satisfaction with prolonged exposure therapy delivered via telemedicine - Prolonged exposure therapy homework adherence - Change in posttraumatic stress disorder symptom severity - self-reported ### Location - Facility: University of Vemont, Burlington, Vermont, 05401, United States @@
## Understanding Patient Engagement Trends in TBI Clinical Research - NCT ID: NCT06288698 - Study ID: 53955721 - Status: NOT_YET_RECRUITING - Start Date: 2025-03 - Completion Date: 2027-03 - Lead Sponsor: Power Life Sciences Inc. ### Study Description Clinical trials, specifically focused on TBI, are crucial in assessing the safety and efficacy of new treatments. These trials serve as fundamental instruments in determining whether emerging medications outperform standard therapies, providing compelling evidence to support wider implementation.The main goal is to thoroughly scrutinize trial completion rates and voluntary withdrawals among this particular group of patients. ### Conditions - TBI ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Number of TBI patients who decide to enroll in a clinical research - Rate of TBI patients who remain in clinical trial to trial completion Secondary Outcomes ### Location - Facility: Power Life Sciences, San Francisco, California, 94107, United States @@
## Percutaneous Trigger Finger Release Concomitant Steroid Injection Versus Percutaneous Trigger Finger Release Alone - NCT ID: NCT06288685 - Study ID: 73/256 - Status: COMPLETED - Start Date: 2023-10-11 - Completion Date: 2024-01-30 - Lead Sponsor: Police General Hospital, Thailand ### Study Description Background:Percutaneous A1 pulley release is a cost-effective and straightforward procedure with outcomes comparable to open A1 pulley release. Postoperative pain is a prevalent concern. Corticosteroid injection is a common nonoperative treatment for trigger finger, providing favorable outcomes but associated with a notable risk of recurrence. Numerous studies have explored the combined approach of percutaneous trigger finger release with corticosteroid injection. However, to date, there is no report on early postoperative results.Objective:To conduct a comparative analysis of early postoperative outcomes between percutaneous A1 pulley release with steroid injection and percutaneous A1 pulley release alone.Study Design \& Methods:This study constitutes a randomized controlled trial involving patients with trigger finger who underwent percutaneous release surgery from October 2023 to January 2024. A total of 38 patients were enrolled, with 18 assigned to the percutaneous A1 pulley release with steroid injection group and 20 to the percutaneous A1 pulley release alone group. Postoperative assessments included pain scores using the Visual Analog Scale (VAS), evaluation of quality of life through the QuickDASH score (qDASH), patient satisfaction, and complications. ### Conditions - Trigger Finger - Percutaneous A1 Pulley Release - Steroid Injection - Postoperative Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - percutaneous A1 pulley release - Triamcinolone ### Outcomes Primary Outcomes - postoperative pain score Secondary Outcomes - hand function by quickDASH - patients satisfaction ### Location - Facility: Police General Hospital, Bangkok, Pathumwan, 10330, Thailand @@
## IBS Skin Patch Test Food Allergy Study - NCT ID: NCT06288672 - Study ID: 1002 - Status: RECRUITING - Start Date: 2023-08-15 - Completion Date: 2025-12 - Lead Sponsor: IBS-80, LLC ### Study Description Participants with IBS are skin patch tested (no needles) to 80 different foods and food additives, compounded for patch testing, in search of food allergies. The testing requires 3 office visits within a 4 or 5 day period. The patches are taped to the back at Visit #. At Visit #2 48 hours later, the patches are removed from the skin and the outside border of each patch is marked with a felt tip marker. At Visit #3 (final visit) 1 or 2 days later, the patch test reading is performed by the doctor-investigator. An allergy is identified as a small red mark where the food was in contact with the skin for 48 hours. Those participants found to have food allergies are then placed on an avoidance diet (no calorie restriction) for 16 weeks where they either avoid eating the food(s) to which they are allergic (the \"true\" avoidance diet) or food(s) to which the testing did not show an allergy (this is called the \"sham\" avoidance diet). There is a 50/50 chance of going on either avoidance diet. The avoidance diet is assigned in such a way that neither the participant or the doctor-investigator knows which diet is being followed. After the 16 weeks, the participants answers a brief online questionnaire that asks about the IBS symptoms while following the avoidance diet. After the 16 week avoidance diet and final questionnaire are completed, those participants who were on the sham diet will be told of their true food allergies which they may try avoiding on their own. ### Conditions - Irritable Bowel Syndrome ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - True avoidance diet - Sham avoidance diet ### Outcomes Primary Outcomes - Post-Avoidance Diet Relative IBS Symptom Global Assessment Secondary Outcomes ### Location - Facility: Adult and Pediatric Dermatology, Marlborough, Massachusetts, 01752, United States @@
## aSAH Treatment Based on Intraventricular ICP Monitoring: A Prospective, Multicenter, Randomized and Controlled Trial - NCT ID: NCT06288659 - Study ID: KY2024-050 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2026-12-30 - Lead Sponsor: Huashan Hospital ### Study Description ASTIM is a multicenter, prospective, randomised, blinded end-point assessed trial, to investigate the efficacy and safety of treatment based on intracranial pressure monitoring in improving the prognosis of patients with aneurysmal subarachnoid hemorrhage. ### Conditions - Aneurysmal Subarachnoid Hemorrhage - Intracranial Pressure Increase ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Intraventricular intracranial pressure monitoring ### Outcomes Primary Outcomes - The rate of good neurological functional prognosis Secondary Outcomes - The rate of good neurological functional prognosis - The rate of good prognosis by Glasgow Outcome Scale-Extended (GOS-E) - Mortality - Incidence of VP shunt-related hydrocephalus - Incidence of Delayed Cerebral Ischemia - Incidence of epilepsy ### Location - Facility: Department of Neurosurgery, Huashan Hospital, Fudan University, Shanghai, Shanghai, 200000, China @@
## Using Infrared Spectroscopy to Analyze Volatile Organic Compounds (VOCs) in the Breath of Patients With Lung Cancer - NCT ID: NCT06288646 - Study ID: ROMEO 101712 - Status: RECRUITING - Start Date: 2023-04-24 - Completion Date: 2024-12-15 - Lead Sponsor: Picomole Inc ### Study Description The goal of this clinical trial is to compare breath samples from patients with lung cancer, those with stable lung nodules, and individuals without lung cancer. The main questions it aims to answer are whether breath patterns are different in these groups and to see if breath patterns change after treatment in patients with lung cancer.Participants will be asked to provide one breath sample, and two if they get treated. They will also be asked to fill out a questionnaire about their background and medical history. ### Conditions - Lung Cancer - Non Small Cell Lung Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Differences in Breath Spectra of Lung Cancer, Stable Pulmonary Nodules, and Controls Secondary Outcomes - Differences in breath spectra of patients with lung cancer before and after treatment ### Location - Facility: Vitalite Health Network, Moncton, New Brunswick, E1C 8X3, Canada @@