pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Safety and Efficacy of ADC189 in Children 2-11 Years Old With Influenza
NCT Number: NCT06507813
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Influenza Type A|Influenza Type B
Interventions: DRUG: ADC189 tablets|DRUG: Baloxavir Marboxil tablets|DRUG: Placebo of ADC189 tablets|DRUG: Placebo of Baloxavir Marboxil tablets|DRUG: ADC189 granules|DRUG: Placebo of ADC189 granules|DRUG: Placebo of Oseltamivir granules|DRUG: Oseltamivir granules
Sponsor: Jiaxing AnDiCon Biotech Co.,Ltd
Sex: ALL
Age: CHILD
Enrollment: 165
Study Design: Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-06-28
Completion Date: 2025-06-01
Locations: Beijing Children's Hospital,Capital Medical University, Beijing, Beijing, China

Summary:
Currently, there is only one treatment which only need one single oral dose for influenza in children five years above (Baloxavir marboxil) in China. This study will test a medicine for influenza in children younger than 5 year of age to see if it is safe and effective.

This is a multicenter, randomized, double-blind, controlled Phase III clinical study.

The study evaluates the pharmacokinetics, safety and efficacy of ADC189 tablets/granules following a single oral dose in children aged 2 to 11 years with influenza.

Primary Outcome Measures: The safety of study drug, Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs), An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. A SAE is any significant hazard, contraindication, side effect that is fatal or life-threatening, requires hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability/ incapacity, is a congenital anomaly/ birth defect, is medically significant or requires intervention to prevent one or other of the outcomes listed above., From Day 1 up to 15 days
Secondary Outcome Measures: Plasma Concentrations of ADC189 and ADC189-I07, ADC189-I07 is an active metabolite of ADC189. Four plasma samples were collected in 4 time points from each patient. This data is collected for Pop PK analysis., From Day 1 up to 14 days, 4 time points.|Time to Resolution of Influenza Symptoms, Subjects or parents or caregivers were asked to provide an assessment of age-appropriate influenza symptoms on a CARIFS Questionare., From Day 1 up to 14 days
Cancer as a complicATion in reCipients of Autologous Hematopoietic Stem Cell Transplantation for Autoimmune Disease iNdiCation trEated in FRance and Canada?
NCT Number: NCT06507800
Acronym: CATCH CANCER
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Autoimmune Diseases
Interventions: OTHER: Observational cohort
Sponsor: Assistance Publique - Hôpitaux de Paris
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 500
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-01
Completion Date: 2025-09-01

Summary:
Autologous Hematopoietic Stem Cell Transplantation (AHSCT) is a treatment option for several types of Autoimmune Disease (AD) in patients who remain active despite disease modifying therapies. In this setting, AHSCT was shown to improve overall survival, event free survival and quality of life, with a grade A level evidence for systemic sclerosis (SSc) and multiple sclerosis (MS) patients and its benefit varies according to the AD type and the patient status for the other indications. The number of AHSCT for AD has increased in the past twenty years at each country level in Europe and also in Canada.

Information about cancer after AHSCT for AD is scant, although the AD patients population per se has an increased rate of cancer. This cancer risk can be explained in part by the long term use of immunosuppressive drugs or by other risk factors related to the AD (as in SSc or Crohn) or to the patient. In addition to pretransplant potential risk factors for cancer in AD patients, the use of conditioning regimen, which may vary from low, medium or high immunosuppressive to myeloablative chemotherapy when irradiation is added to the proecedure, may favor the onset of cancer after AHCST. Updated analysis and review of the literature until march 2023 led us to identify only twenty-two cases of cancer or hematological malignancies reported after AHSCT recipients for an AD.

The incidence of cancer after AHSCT for AD was never considered as a primary endpoint in any previous study.

In this context, the aim of this study is to describe the incidence of cancer after autologous hematopoietic stem cell transplantation (AHSCT) for auto-immune diseases (AD) in the French MATHEC (French scientific network for AD and cellular therapies) and the Ottawa and Calgary patients cohorts from Day 0 until twenty years follow up after AHSCT.

Primary Outcome Measures: Cumulative incidence of any cancer after AHSCT for an autoimmune indication, Description of the cancers by site according to the International Classification of Diseases for Oncology, 3rd Edition, Up to 22 years after AHSCT
Secondary Outcome Measures: Cumulative incidence of cancer by age and sex, Up to 22 years after AHSCT|Incidence of Non-relapse mortality (NRM), Up to 22 years after AHSCT|Incidence of disease relapse/progression, Up to 22 years after AHSCT|Overall survival (OS), Up to 22 years after AHSCT|Causes of death (Causes of death will be classified as related to primary AD disease, the secondary cancer or any other cause)., Up to 22 years after AHSCT
Evaluation of the Impact of the EDIT-B® Blood Test on the Health Status of Patients Presenting a Major Depressive Episode. Clinical Utility and Medico-Economic Aspects
NCT Number: NCT06507787
Acronym: SEM EDIT-B
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Bipolar Disorder|Major Depressive Disorder
Interventions: DIAGNOSTIC_TEST: EDIT-B test|DIAGNOSTIC_TEST: EDIT-B test (without giving result)
Sponsor: Alcediag
Collaborators: BPIfrance|Synlab Holding Deutschland GmbH
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 450
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-09
Completion Date: 2026-08

Summary:
Depression is one of the most common mental disorders, affecting nearly 10% of men and 20% of women worldwide. It is associated with a significant increase in mortality, mainly due to suicidal behavior. The Diagnostic and Statistical Manual of Mental Disorders (DSM) defines a Major Depressive Episode (MDE) by a combination of at least five different symptoms, with at least one depressed mood or loss of interest. MDEs can occur in isolation or as part of Major Depressive Disorder (MDD) or bipolar disorder (BD). Bipolar disorders affect 2% of the world's population and are defined by episodes of mania (Type I BD) or hypomania (Type II BD) alternating with episodes of depression and periods of remission.

Depression occurring whether in the context of BD or MDD is defined with the same clinical criteria. However, the pharmacological treatments are different in the two groups. In particular, antidepressants prescribed without a thymoregulator in bipolar patients can lead to a worsening of the episode, favoring suicidal behavior or a manic turn.

The average interval between the onset of BD symptoms and appropriate diagnosis is estimated to be approximately 7 years, which delays appropriate management and treatment and increases the risk of suicide.

Biological markers able to differentiate between the different types of depression were lacking before the advent of EDIT-B®; one of the main objectives of this research is to measure the clinical impact of the use of EDIT-B® in the short and medium term on the management of patients with BD and major depression. The health economic aspect will also be considered.

In total, 450 patients in two different groups (EDIT-B® group and control group) will be recruited over a study timeline of 24 months. Study participation is over 6 months with 4 visits.

Primary Outcome Measures: Average change in MADRS between inclusion and 15-16 weeks visit., MADRS is a widely recognized and validated instrument for assessing the severity of depressive symptoms. It has demonstrated high sensitivity to changes in depressive symptomatology. It is capable of detecting even subtle variations in symptom severity, allowing for precise evaluation of treatment efficacy.

Change in MADRS is commonly assessed at 8 weeks, however to allow for the time to receive EDIT-B® and alter treatment strategy if necessary, a 15-16-weeks window was chosen., 4 months (from inclusion visit to 15-16 weeks visit)
Development of 3D Reconstruction Surgical Planning Model
NCT Number: NCT06507774
Status: ACTIVE_NOT_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Lung Cancer
Interventions: DEVICE: 3D Reconstruction Technology
Sponsor: Yangdi
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 300
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-01-01
Completion Date: 2025-12-31
Locations: Affiliated Hospital of Hebei University, Baoding, Hebei, 071000, China

Summary:
This project focuses on the development of a precision multi-organ surgical planning model aided by artificial intelligence (AI), computer-aided design (CAD), multi-material 3D printing, and multimodal 3D modeling. The integration of these advanced technologies aims to enhance the accuracy and efficiency of preoperative planning for complex surgical procedures involving multiple organs. By leveraging AI and CAD, the project seeks to create detailed, patient-specific 3D models that incorporate various imaging modalities. These models will be used to guide multi-material 3D printing, producing highly accurate replicas of anatomical structures. The ultimate goal is to improve surgical outcomes by providing surgeons with precise and comprehensive tools for planning and executing intricate surgeries.

Primary Outcome Measures: Operation Time, Measure the total duration of the surgery in minutes., During the surgery|Blood Loss, Assess the total blood loss during surgery in milliliters., During the surgery|Postoperative Complications, Record any complications within 30 days post-surgery., Within 30 days post-surgery
The Effects of Mannose Supplementation on Glycosylation and Protein Levels in Human Sera
NCT Number: NCT06507735
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Physiological Stress
Interventions: DIETARY_SUPPLEMENT: Mannose
Sponsor: University of Texas Southwestern Medical Center
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 5
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-08-01
Completion Date: 2024-12-01

Summary:
The purpose of our study is to investigate the effects of supplemental mannose on sera of humans who are healthy. We will perform proteomics studies to elucidate changes to glycan structure and protein level changes. We hypothesize that we may find that mannose supplies more properly glycosylated protein substrate and helps expedite protein synthesis, that excess mannose leads to alternative glycan structures which confer improved stability, or that there are new sites that become glycosylated after mannose supplementation.

Primary Outcome Measures: Changes to glycan structure, Glycopeptide mass spectrometry will be applied to the major glycoproteins present in serum., ~1 month|Change in glycoprotein levels, Standard laboratory methods such as ELISA in either research or clinical laboratory settings (Roche Cobas or similar platform)., ~1 month
Closed Sinus Augmentation With a Calcium Phosphosilicate Putty
NCT Number: NCT06507709
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Dental Implant|Maxillary Sinus Floor Augmentation
Interventions: PROCEDURE: Low volume CBCT
Sponsor: The University of Texas Health Science Center at San Antonio
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 25
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-09
Completion Date: 2027-06
Locations: The University of Texas Health Science Center at San Antonio, San Antonio, Texas, 78229, United States

Summary:
The goal of this clinical study is to learn if cone beam computed tomography (CBCT) or 3-dimensional x-ray can help to let the investigator know if dental implant placement can be done after performing closed sinus surgery.

The study will look at the structure of your gum where the implant will be placed after performing the surgery using 3-D x-ray and compare that to how the structure of your gum looks 6 months later.

The 3-D imaging will happen after standard of care surgery to prepare your gum for an implant and then 6 months later to verify that the site is ready for the implant.

Primary Outcome Measures: Bone Volume change, Bone volume changes will be reported as a percentage, with mean, median, and standard deviation., Baseline to 6 months
Comparison of the Efficiency of Two Different Methods in Managing Early Postoperative Thirst
NCT Number: NCT06507696
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Patient Satisfaction|Nursing Caries|Post-Op Complication
Interventions: OTHER: Ice Application|OTHER: Wetted Gauze Application
Sponsor: Acibadem University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 240
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: OTHER
Start Date: 2023-01-01
Completion Date: 2023-03-31
Locations: Yasemin Uslu, İstanbul, Ataşehir, 34752, Turkey|Acıbadem University, İstanbul, Eyalet/Yerleşke, 34752, Turkey

Summary:
Postoperative thirst is one of the most common problems in patients. Thirst is a subjective symptom. Thirst can cause unwanted problems in patients such as anxiety, discomfort and nausea. It may even cause anxiety, hypertension, dysrhythmia, non-compliance with treatment and increased need for anesthesia. Although different methods have been applied in the management of thirst in the existing literature and positive results have been obtained, studies with high evidence value are very limited. The aim of this study was to compare the effectiveness of two different methods in thirst management.

Primary Outcome Measures: Thirst score, Visual Comparion Scale (VCS) was used to assess thirst. In this scale, thirst was graded from 0 to 10. 0=no thirst, 10=the most severe thirst.

The scale was evaluated as 0-3 points mild thirst, 4-6 points moderate thirst, 7-10 points severe thirst.

* First follow-up (T1): Patient's thirst level measured by VCS and intervention (ice application or wet gauze application)
* Second follow-up (T2); evaluation was performed with VCS 5 minutes after the application.
* Third follow-up (T3); evaluation was performed with VCS 30 minutes after the application.

  * Fourth follow-up (T4); assessment was performed with VCS 60 minutes after the application.

Fifth follow-up (T5); evaluation was performed with VCS 90 minutes after the application.

The thirst level of the patient was measured 5 times in total. At 90 minutes, data collection was terminated.

Scores between 5 measurement values were compared., Using Thirst Visual Comparion Scale score after immediately after surgery (T1) 5th min.(T2), 30th min.(T3), 60th min.(T4), 90th min.(T5)
Evaluate the Efficacy and Safety of Radiotherapy Combined With Ripretinib in the Treatment of Unresectable Advanced GIST
NCT Number: NCT06507683
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Gastrointestinal Stromal Tumors
Interventions: RADIATION: simultaneous integrated boost intensity-modulated radiation therapy combined with ripretinib
Sponsor: First Affiliated Hospital of Chongqing Medical University
Collaborators: Peking University Cancer Hospital & Institute
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 32
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-05-28
Completion Date: 2027-07
Locations: The First Affiliated Hospital of Chongqing Medical University, Chongqing, Chongqing, 400016, China

Summary:
The goal of this prospective study is to learn whether there is a synergistic effect when radiotherapy is combined with ripretinib in the treatment of patients with unresectable advanced GIST. It will also learn about the safety of this regimen.The main questions it aim to answer is: Dose radiotherapy combined with ripretinib prolong the time to disease progression for patients with advanced GIST?

Primary Outcome Measures: Time to disease progression of irradiated lesions, Time from start of radiotherapy to progression of irradiated lesions, Approximately 12 months since the first subject enrolled
Secondary Outcome Measures: Time to disease progression of any lesions, Time from start of radiotherapy to progression of any lesions, Approximately 12 months since the first subject enrolled|Overall survival (OS), the time from start of radiotherapy to all-cause death., Approximately 12 months since the first subject enrolled|Objective Response Rate(ORR) of irradiated lesions, the percentage of patients whose efficacy is confirmed as complete response(CR) or partial responses(PR) based on mRECIST 1.1, Approximately 12 months since the first subject enrolled
Point of Care Ultrasound for the Detection of Esophageal Food Bolus
NCT Number: NCT06507670
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Esophageal Foreign Body|Esophageal Obstruction
Interventions: DIAGNOSTIC_TEST: Point of care ultrasound
Sponsor: WellSpan Health
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-01
Completion Date: 2027-01-01
Locations: WellSpan Health York Hospital, York, Pennsylvania, 17403, United States

Summary:
This will be a prospective, observational, case-control study of adult patients presenting to the WellSpan York Hospital Emergency Department (YHED) with signs and symptoms of esophageal food or foreign body impaction. Point of care ultrasound (POCUS) will then be performed by a trained emergency physician to collect ultrasound data, including the presence or absence of direct visualization food bolus/foreign body, as well as secondary markers of dilatation, such as maximal esophageal area. Investigators will also enroll an age/sex-matched control group of asymptomatic individuals to establish baseline esophageal measurements.

Patients will otherwise receive medical treatment per standard of care. Subsequent interventions will also be documented, including glucagon, carbonated beverages, and esophagogastroduodenoscopy (EGD). If patients remain in the ED and improve without need for EGD they will undergo repeat ultrasound. Chart review at 1 month will be performed to establish results of EGD including improvement, recurrence, or presence of pathologic abnormalities. The investigators aim to establish normal and abnormal parameters to aid in the diagnosis of esophageal food impactions to predict need for definitive EGD management.

Primary Outcome Measures: Presence or absence of esophageal foreign body/food impaction, Presence of absence of esophageal foreign body/food impaction on esophagogastroduodenoscopy, Within 48 hours of index visit (Emergency department arrival to emergency department or hospital discharge)
Secondary Outcome Measures: Number/proportion of subjects experiencing resolution of symptoms with standard medical therapies, Number/proportion of subjects experiencing resolution of symptoms with standard medical therapies, including glucagon and carbonated beverages, Within 48 hours of index visit (Emergency department arrival to emergency department or hospital discharge)|Number/proportion of subjects requiring endoscopic intervention, Number/proportion of subjects needing interventional procedures during esophagogastroduodenoscopy due to esophageal symptoms, Within 48 hours of index visit (Emergency department arrival to emergency department or hospital discharge)
Effect of Empagliflozin on Left Atrial Function in Adults at Risk for Heart Failure
NCT Number: NCT06507657
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: EARLY_PHASE1
Conditions: Hypertension|Cardiovascular Diseases
Interventions: DRUG: empagliflozin|DRUG: Placebo tablet
Sponsor: University of Minnesota
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-15
Completion Date: 2029-01-15

Summary:
Sodium-glucose cotransporter 2 inhibitors (SGLT2i) reduce CVD events, including incident HF. SGLT2 is a glucose transport protein in the kidneys. Inhibition of this protein results in glucosuria and lower serum blood sugar. The SGLT2i medications were initially approved to treat type 2 diabetes (T2D). In 2015, Zinman et al. published the first large randomized clinical trial (RCT) demonstrating a lower composite CVD outcome in adults with T2D treated with empagliflozin compared to placebo (HR 0.85, 95% CI 0.74-0.99). In the specific case of empagliflozin, the hazard ratio was 0.75 (95% CI 0.65-0.86) for HFrEF 8 and 0.79 (95% CI 0.69-0.90) for HFpEF using a treatment dose of 10mg daily.

The purpose of this placebo-controlled, double-blinded, randomized pilot study is to investigate the effect of empagliflozin on left atrial (LA) function in 80 patients who are at risk for heart failure. Participants will be randomized 1:1 to either intake of a 10mg empagliflozin oral tablet or a matching placebo once daily.

Primary Outcome Measures: change in LA function, LA function will be quantified by assessing LA reservoir, conduit, and contractile strain with 2DE at baseline and 9 months., 9 months
Secondary Outcome Measures: change in left ventricular ejection fraction, 9 months|change in global longitudinal strain, 9 months|change in mass (indexed to body surface area), 9 months|change in E/e' ratio, 9 months|change in plasma protein levels: DLK-1 (protein delta homolog 1), 9 months|change in plasma protein levels: GDF15 (growth differentiating factor 15), 9 months|change in plasma protein levels: Spondin-1, 9 months|change in plasma protein levels: IGBPF-7, 9 months|change in plasma protein levels: THBS-2 (thrombospondin 2), 9 months|change in plasma protein levels: IGFBP-1 (insulin-like binding factor protein 1), 9 months|change in plasma protein levels: FABP-4 (fatty acid-binding protein 4), 9 months|change in plasma protein levels: CCL16 (C-C motif chemokine 16), 9 months|change in cardiovascular disease biomarker C-reactive protein (CRP), 3 months and 9 months|change in cardiovascular disease biomarker Troponin, 3 months and 9 months|change in cardiovascular disease biomarker NT-proBNP, 3 months and 9 months|changes in blood pressure ration, 1, 3 and 9 months
Dose-Escalating Study of Pfs230D1 in Combination With R21 in Matrix-M in African Adults
NCT Number: NCT06507605
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Prevention of Malaria Transmission and Clinical Malaria
Interventions: BIOLOGICAL: R21|BIOLOGICAL: Pfs230D1-CRM197|BIOLOGICAL: Pfs230D1-EPA|OTHER: Matrix-M
Sponsor: Serum Institute of India Pvt. Ltd.
Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
Sex: ALL
Age: ADULT
Enrollment: 240
Study Design: Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-07-30
Completion Date: 2025-10-30
Locations: University of Science, Technique and Technology of Bamako (Usttb), Bamako, Mali

Summary:
This is a Phase 1, individually randomized, double-blind, dose escalating study designed to evaluate the safety, tolerability, and immunogenicity of Pfs230D1 conjugate vaccines, R21 nanoparticle vaccine, or their combination conjugate vaccines, formulated on Matrix-M in healthy African adults aged 18 to 50 years.

Primary Outcome Measures: Number of Participants with Immediate adverse events, Occurrence of immediate adverse events, within 30-minutes following each dose|Number of Participants with Solicited local adverse events, Occurrence of solicited local adverse events, for 7 days following each dose|Number of Participants with Solicited systemic adverse events, Occurrence of solicited systemic adverse events, for 7 days following each dose|Number of Participants with Unsolicited adverse events, Occurrence of all unsolicited adverse events, for 28 days following each dose|Number of Participants with Abnormal Laboratory Values post-vaccination, Any significant change from baseline for laboratory values defined as adverse events, within 7 days following each dose|Number of Participants with Serious adverse events, Occurrence of serious adverse events, Till 6 months post last dose
Secondary Outcome Measures: Anti-NANP IgG antibodies, Comparison of anti-NANP IgG antibodies, at 2 weeks post dose 3 in all treatment arms|Anti-Pfs230D1 IgG antibodies, Comparison of Anti-Pfs230D1 IgG antibodies, at 2 weeks post dose 3 in all treatment arms
Oxidative-reductive Processes and the Degree of Inflammation in Saliva With Conventional Brackets and Clear Aligners
NCT Number: NCT06507592
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Inflammation|Oxidative Stress|TNF-α
Interventions: DIAGNOSTIC_TEST: Saliva samples collection
Sponsor: University of Campania "Luigi Vanvitelli"
Sex: ALL
Age: CHILD, ADULT
Enrollment: 26
Study Design: Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: DOUBLE (INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2023-01-27
Completion Date: 2024-12-21
Locations: Multidisciplinary Department of Medical-Surgical and Dental Specialties, Naples, 80138, Italy

Summary:
The purpose of this prospective observational study is to evaluate the differences in oxidative-reductive processes and the degree of inflammation in saliva during treatment with conventional brackets and clear aligners. The evaluation will be performed by determining the salivary values of Total oxidant status (TOS), total antioxidant status (TAS) and 8-hidroxy-2'-deoxyguanosine (8OHdG).

Primary Outcome Measures: Oxidative-reduction and inflammation, The Total Antioxidant Status (TAS) in saliva samples was measured using a N 2 615700-1KIT Total Antioxidant Status Assay Kit, a colorimetric assay for antioxidant levels in serum or plasma. The Total Oxidant Status (TOS) was measured with a CS0790-1KT Antioxidant Assay Kit, which includes all necessary reagents to measure total antioxidant capacity in plasma, serum, urine, saliva, cells, and tissue lysates. It also measures the radical cation (ABTS+) scavenging capacity. The 8-Hydroxy-2'-deoxyguanosine (8-OHdG) and Tumor Necrosis Factor-α (TNF-α) levels were determined using an E-EL-H0109 HUMAN TNF-ALPHA ELISA KIT, which detects protein levels quantitatively in serum, plasma, or cell lysate supernatants., One year
Secondary Outcome Measures: Potential risk factors, Using plastic-based or metallic materials for orthodontic devices can increase saliva's oxidative and inflammatory status, potentially correlating with conditions like gingivitis, dental caries, periodontitis, or minor lesions such as aphthous ulcers. Oxidative stress impairs the ability to counteract further pathological events. Free radicals or reactive oxygen species (ROS) are typically generated during biochemical redox reactions as part of normal cell metabolism (for protection against infectious agents) and in response to environmental factors like UV radiation, cigarette smoke, pollutants, and gamma radiation. Once formed, ROS can attack cellular components in the mouth, damaging lipids, proteins, and DNA in oral tissues. This damage can initiate or exacerbate oral diseases, including gingivitis, dental caries, periodontitis, and other inflammatory conditions., Two years
Dental Emergencies Among Patients of the Health Care Access Center at the University Hospital of Nancy
NCT Number: NCT06507540
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Community Dentistry|Emergencies
Interventions: OTHER: No intervention (observational study)
Sponsor: Central Hospital, Nancy, France
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 350
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-22
Completion Date: 2024-12
Locations: CHRU Nancy, Nancy, 54000, France

Summary:
The dental Health Care Access Center at the University Hospital of Nancy opened in January 2023. The patients ot the dental Health Care Access Center consulting the dental department have largely been treated as dental emergencies. However, to date, no study has been carried out into the nature of these patients' consultations or treatments. This new patient management has necessitated adaptations within the dental department, but there are no data to enable us to better understand and organize the care of these patients. Moreover, the cost of dental emergencies has not been estimated.

Our hypotheses are that patients of the dental Health Care Access Center consulted mainly the dental departement for painful emergencies and that the emergency dental cares were provided rapidly and at low cost. On the other hand, patient flow was probably correlated with the days when a social worker of the dental Health Care Access Center was present, referring patients to the dental department.

The main aim of the study is to describe the nature of emergency dental care provided to patients of the dental Health Care Access Center at the dental department of the University Hospital of Nancy.

The secondary objectives are: i) to describe the temporality of dental emergency consultations for patients of the dental Health Care Access Center, ii) to describe the rate of dental consultations secondary to an initial emergency consultation, and iii) describe the direct cost of emergency consultations and treatment.

Primary Outcome Measures: Dental care reported in the medical record, Types of emergency dental care parformed among patients referred by the Health Care Access Center at the dental service of the University Hospital of Nancy, 18 months
Secondary Outcome Measures: Days of dental emergencies, Month and day of the week of emergency consultations for patients of the dental Health Care Access Center, 18 months|Follow-up, Number and delay of dental consultations in the dental service following an initial emergency consultation, 18 months|Costs, Cost of consultations and treatments performed at the dental service, 18 months
Blinatumomab and Auto-HSCT Sandwich Strategy as Consolidation Therapy for B-ALL
NCT Number: NCT06507514
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: B-cell Acute Lymphoblastic Leukemia
Interventions: COMBINATION_PRODUCT: blinatumomab and auto-HSCT "sandwich " strategy
Sponsor: The First Affiliated Hospital of Soochow University
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 4
Study Design: Allocation: NA|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-04-01
Completion Date: 2030-04-01
Locations: The First Affliated Hospital of Soochow University, Suzhou, Jiangsu, 215006, China

Summary:
Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is the main method potentially curing adult B-ALL, but the high treatment-related mortality (NRM) affects overall survival (OS). Autologous stem cell transplantation (auto-HSCT) can significantly reduce NRM but has a higher relapse rate. Studies have confirmed that achieving MRD negativity before Auto-HSCT can effectively reduce post-transplant relapse, achieving similar efficacy to allo-HSCT. The efficacy of blinatumomab in clearing MRD has been confirmed. Therefore, using blinatumomab combined with Auto-HSCT for B-ALL patients seems to make it possible to achieve benefits in leukemia free survival（LFS） and OS. The investigators first conducted blinatumomab and auto-HSCT "sandwich " strategy as consolidation therapy in patients with B-ALL. The main Purpose of this study was to observe the safety and efficacy of this new strategy.

Primary Outcome Measures: Overall survival（OS）, It is measured from the date of entry into this trial to the date of death from any cause; patients not known to have died at last follow-up are censored on the date they were last known to be alive., 4 years|leukemia free survival（LFS）, It is measured from the date of achievement of a remission until the date of relapse from CR, or CRi, or death from any cause; patients not known to have any of these events are censored on the date they were last examined., 4 years
Secondary Outcome Measures: Number of adverse events, Adverse events are evaluated with CTCAE V5.0 from the date of entry into this trial., 4 years
Effects of Exercise Training With Blood Flow Restriction
NCT Number: NCT06507501
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Healthy
Interventions: OTHER: Low Load Blood Flow Restriction Exercise Training (LL-BFRE)|OTHER: High Load Resistive Exercise Training (HL-RE)
Sponsor: Atlas University
Sex: ALL
Age: ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-04-15
Completion Date: 2024-07-25
Locations: Onur Turan, Istanbul, Kağıthane, 34408, Turkey

Summary:
In this study, it was aimed to compare the effects of low load blood flow restriction exercise (LL-BFRE) training versus high load resistance exercise (HL-RE) training in healthy young individuals on the parameters of lower extremity muscle strength, dynamic and static postural balance, functional performance and cognitive performance.

Primary Outcome Measures: Muscle Strength, Knee extansor and flexor muscle strength will be measured by using Hoggan Scientific; MicroFET2 brand hand-held dynamometer., Baseline to 6 weeks after exercise training|Dynamic Balance, Dynamic balance will be assessed by using Y-Balance Test Lower Extremity., Baseline to 6 weeks after exercise training|Static Balance, Static balance will be assessed by using Single Leg Stance Test with eyes open and closed., Baseline to 6 weeks after exercise training
Secondary Outcome Measures: Funtional Performance, Functional performance will be assessed by using 6 Minute Walk Test., Baseline to 6 weeks after exercise training|Funtional Performance, Functional performance will be assessed by using Single Leg Hop Test., Baseline to 6 weeks after exercise training|Cognitive Performance, Cognitive performance will be assessed by using Trail Making Test., Baseline to 6 weeks after exercise training|Cognitive Performance, Cognitive performance will be assessed by using Stroop Colour and Word Test., Baseline to 6 weeks after exercise training
Other Outcome Measures: Sociodemographic Information, Age (years), gender, education level, smoking \& alcohol habits, whether they have a chronic disease, whether they use any medication, and exercise habits of the individuals participating in the study will be recorded., Baseline|Physical Assessment, Height (cm), body weight (kg) and body mass index (BMI) (kg/m2) will be measured. Height will be measure via stadiometer, body weight will be measure via weighing device and BMI will be calculated using with the formula "weight/height (m)2"., Baseline
A Diagnostic Prediction Model for Prostate Cancer in Patients With PI-RADS Score 3
NCT Number: NCT06507462
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Prostate Cancer
Interventions: PROCEDURE: prostate biopsy
Sponsor: Anhui Provincial Hospital
Sex: MALE
Age: ADULT, OLDER_ADULT
Enrollment: 500
Study Design: Observational Model: |Time Perspective: p
Start Date: 2021-01-01
Completion Date: 2024-12-31
Locations: Department of Urology, The First Affiliated Hospital of Bengbu Medical University, Bengbu, Anhui, 233000, China|Department of Urology, The First Affiliated Hospital of USTC, Hefei, Anhui, 230001, China|Department of Urology, The First Affiliated Hospital of Wannan Medical College, Wuhu, Anhui, 241000, China

Summary:
The goal of this observational study is to construct a predictive model for improving the diagnostic accuracy in patients with PI-RADS score of 3. The main aims of this study are:

* Construct a diagnostic model of patients with PI-RADS of score.
* Internal and external validation of the model.
* Decision curve analysis. The data of participants was collected retrospectively.

Primary Outcome Measures: Multivariate logistic regression analyses and calculate the odds ratios (95% confidence interval ) of the clinical variables for clinically significant prostate cancer, The clinically significant prostate cancer was defined as Gleason score ≥ 3+4, through study completion, an average of 3 months
Secondary Outcome Measures: Validation by calculating the C-statistics, drawing ROC curves (AUC values) and calibration curves., Evaluate the discrimination and calibration of the model constructed by logistic regression analyses, through study completion, an average of 3 months
The Phase III Clinical Study of Herombopag for the Treatment of Thrombocytopenia in Chronic Liver Disease Patients Undergoing Elective Invasive Surgery
NCT Number: NCT06507436
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Thrombocytopenia in Chronic Liver Disease Patients Undergoing Elective Invasive Surgery
Interventions: DRUG: Herombopag tablets|DRUG: Herombopag placebo tablets
Sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 101
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-31
Completion Date: 2025-09-30
Locations: Zhongshan Hospital, affiliated with Fudan University, Shanghai, Shanghai, 200032, China

Summary:
This study includes Part A and Part B. Part A is a dose-finding study for subjects with chronic liver disease-related thrombocytopenia scheduled for elective surgery. Part B is a multicenter, randomized, double-blind, placebo-controlled Phase III clinical study designed to evaluate the efficacy and safety of Herombopag compared to placebo in patients with chronic liver disease-related thrombocytopenia undergoing elective invasive surgery.

Primary Outcome Measures: Part A: CL/F, 0 minute to 5 days|Part A: Vc/F, 0 minute to 5 days|Part A: ka, 0 minute to 5 days|Part A: Q/F, 0 minute to 5 days|Part A: AUC0-tau, 0 minute to 5 days|Part A: Cmax, 0 minute to 5 days|Part A: Kin, 0 minute to 35 days|Part A: Kout, 0 minute to 35 days|Part A: Kdeg, 0 minute to 35 days|Part A: Slope, 0 minute to 35 days|The proportion of subjects whose platelet count is ≥50×10^9/L within 24 hours before surgery and has increased by ≥20×10^9/L from baseline, and who have not received platelet transfusion or other treatments to raise platelet levels before surgery, Part B, 0 minute to 11 days
Secondary Outcome Measures: The proportion of subjects with a platelet count of ≥50×10^9/L within 24 hours before surgery, 0 minute to 11 days|The duration of time during the study when the platelet count remains ≥50×10^9/L, 0 minute to 35 days
Performance of the SeptiCyte LAB Test for Antibiotic Stewardship in Mesenteric Ischemia
NCT Number: NCT06507423
Acronym: SPASM
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Acute Mesenteric Ischemia|Sepsis Bacterial|Intra-abdominal Infection
Interventions: DEVICE: Septicyte Lab Test pre operative|DEVICE: Septicyte Lab Test post operative
Sponsor: Central Hospital, Nancy, France
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 15
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-01
Completion Date: 2024-11-01

Summary:
This study will help determine whether the SeptiCyte LAB test can accurately differentiate between SIRS and actual infections in postoperative patients, potentially reducing unnecessary antibiotic use and improving patient outcomes in cases of acute mesenteric ischemia

Primary Outcome Measures: Presence or absence of bacterial coinfection during acute mesenteric ischemia, Septicyte Lab test \< 4 if there is no infection, Day 0 (pre operative)
Secondary Outcome Measures: Diagnostic performance of Septicyte Lab test to rule out the presence of intra-abdominal infection during acute mesenteric ischemia, Sensitivity, Specificity, Positive Predictive Value, Negative Predictive Value of the Septicyte Lab test, Day 0 (pre operative)|Diagnostic performance of PCT to rule out the presence of intra-abdominal infection during acute mesenteric ischemia, Sensitivity, Specificity, Positive Predictive Value, Negative Predictive Value of the PCT, Day 0 (pre operative)|Diagnostic performance of CRP to rule out the presence of intra-abdominal infection during acute mesenteric ischemia, Sensitivity, Specificity, Positive Predictive Value, Negative Predictive Value of the CRP, Day 0 (pre operative)|Change in Septicyte Lab test during the post-operative period to address the influence of surgery on the response of patient's immune system, Value of Septicyte Lab test, Day 1
Additive Effects of Clonidine Used in Propofol Sedation in Colonoscopy
NCT Number: NCT06507410
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Clonidine|Propofol|Sedation|Colonoscopy
Interventions: DRUG: Propofol|DRUG: Propofol combined with clonidine
Sponsor: Tanta University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 62
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-20
Completion Date: 2024-09-01
Locations: Tanta University, Tanta, El-Gharbia, 31527, Egypt

Summary:
The objective of this study was to compare safety, satisfaction, and efficiency outcomes of propofol versus propofol with clonidine in patients undergoing colonoscopy.

Primary Outcome Measures: Patient satisfaction, Patient's satisfaction level will be assessed with a Likert five-item scoring system (1 = Not at all satisfied, 2 = slightly satisfied, 3 = somewhat satisfied, 4 = very satisfied, and 5 = extremely satisfied)., 24 hours postoperatively
Secondary Outcome Measures: Heart rate, Heart rate will be recorded at 30 minutes before induction, at induction, and at the end of surgery., Till the end of surgery|Mean arterial blood pressure, Mean arterial blood pressure will be recorded at 30 minutes before induction, at induction, and at the end of surgery., Till the end of surgery|Side effects, Side effects such as nausea and vomiting, psychological reactions will be noted., 24 hours postoperatively
Dural Puncture Epidural Anesthesia Versus Traditional Spinal Anesthesia for Rigid Cystoscopy
NCT Number: NCT06507397
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Dural Puncture Epidural Anesthesia|Spinal Anesthesia|Rigid Cystoscopy
Interventions: DRUG: hyperbaric bupivacaine and fentanyl|DRUG: plain bupivacaine and fentanyl
Sponsor: Tanta University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 76
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2022-10-01
Completion Date: 2024-03-01
Locations: Tanta University, Tanta, El-Gharbia, 31527, Egypt

Summary:
The main objective of this study was to determine if the dural puncture epidural (DPE) anesthesia provides superior analgesia and better patient satisfaction when compared to traditional spinal anesthesia for rigid cystoscopy.

Primary Outcome Measures: Assessment of the onset of anesthesia, Assessment of the onset by test sensory loss at T10 by pin prick using sterile needle with blunt edge (defined as time from end of injection of bolus dose to 1st sign of sensory block at T10).

Sensory level of the techniques which was assessed at 2 min after end of injection of the drug then every 5 min till the 30 min then every 15 min till end of the surgery., Every 15 minutes till end of the surgery
Secondary Outcome Measures: Time of onset of motor block, Time of onset of motor block was assessed from end of drug injection to time of achieving Breen Modified Bromage scale (BMBS) grade 1) in the lower extremities was assessed by using a BMBS: Grade 1 as complete motor block to Grade 6 as no motor block) and it was assessed at 2 min then every 3 min after injection of the drug till 30 min then every 15 min till the end of the surgery., Till the end of the surgery|Incidence of side effects, Incidence of side effects such as (hypotension and bradycardia) were recorded., 24 hours postoperatively|Number of patients required rescue analgesia, Number of patients required rescue analgesia was measured., 24 hours postoperatively
Combination Letrozole and Clomiphene Citrate Versus Letrozole Alone
NCT Number: NCT06507332
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Polycystic Ovary Syndrome
Interventions: DRUG: Letrozole 2.5mg
Sponsor: Egymedicalpedia
Collaborators: Ain Shams University
Sex: FEMALE
Age: ADULT
Enrollment: 64
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-03-01
Completion Date: 2024-09-10
Locations: Ain Shams University Hospitals, Cairo, Abbasia, Egypt

Summary:
Clomiphene citrate is a non-steroidal triphenylethylene derivative distantly related to diethylstilbestrol. It acts as a selective estrogen receptor modulator (SERM), similar to tamoxifen and raloxifene. All three drugs are competitive inhibitors of estrogen binding to estrogen receptors (ERs) and have mixed agonist and antagonist activity, depending upon the target tissue.

Letrozole is a potent, nonsteroidal, aromatase inhibitor, originally used for postmenopausal breast cancer therapy.

Primary Outcome Measures: Pregnancy Check, The participants required to make pregnancy test after Receiving the drugs of the study, 2 weeks after ovulation