pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Safety and Efficacy of Persistent Atrial Fibrillation Ablation With a Cryoballoon Technology
NCT Number: NCT06567652
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Atrial Fibrillation
Interventions: DEVICE: catheter ablation
Sponsor: Universitair Ziekenhuis Brussel
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Observational Model: |Time Perspective: p
Start Date: 2021-01-01
Completion Date: 2022-09-01
Locations: UZ Brussel Heart Rhythm Management Center, Brussels, 1090, Belgium

Summary:
The goal of this retrospective observational study is to learn about the safety and efficacy of cryoballoon catheter ablation in 80 patients with persistent atrial fibrillation using the PolarX (Boston scientific) cryoablation technology. The main question it aims to answer is if it is safe and effective.

Primary Outcome Measures: Effectiveness, Primary effectiveness failure is defined as the composite of any of the following occurrences:

Failure to achieve acute procedural success at the index procedure (pulmonary vein isolation); More than one repeat procedure during the blanking period (within 90 days post-index procedure); Documented atrial fibrillation, or new onset of atrial flutter or atrial tachycardia event (≥ 30 seconds in duration or from a 10 second 12-lead ECG) Repeat procedure for atrial fibrillation, or new onset of atrial flutter or atrial tachycardia Electrical and/or pharmacological cardioversion

• Prescribed a new antiarrhythmic drug not documented at baseline Prescribed a higher dose of antiarrhythmic drug documented at baseline, 1 year follow-up|Safety of the procedure, Safety is defined as the composite of any of the following occurrences:

Death Myocardial infarction Persistent gastroparesis/injury to vagus nerve Stroke/Transient ischemic attack Thromboembolism/ Air embolism Cardiac tamponade/perforation Pneumothorax Serious vascular access complications\* Pulmonary edema/Heart Failure Ablation related atrioventricular block not attributable to medication effect or vasovagal reaction.

Safety events (0-30 days post procedure) Symptomatic pericardial effusion Safety events (0-360 days post procedure) Atrial esophageal fistula Persistent Phrenic nerve injury Pulmonary Vein Stenosis

\* Including hematoma requiring intervention or prolongation of hospital stay, artero-venous fistulas or pseudoaneurysm., The safety endpoint was evaluated at 7-days 30-days and 1-year follow-up
High Density Mapping in Brugada Syndrome
NCT Number: NCT06567639
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Brugada Syndrome
Interventions: PROCEDURE: Catheter ablation
Sponsor: Universitair Ziekenhuis Brussel
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 15
Study Design: Observational Model: |Time Perspective: p
Start Date: 2018-04-01
Completion Date: 2021-03-31
Locations: UZB, Brussel, Belgium

Summary:
The current study has the following objectives:

1. To characterize the changes in amplitude and duration of epicardial right ventricular outflow tract electrograms captured through a multipolar mapping catheter in patients with Brugada syndrome before and after an ajmaline challenge.
2. To investigate the relationship between the above cited invasive electrophysiological findings and non invasive ECG imaging (ECGI) of the epicardial layer of the right ventricular outflow tract (RVOT) of patients affected by Brugada syndrome and undergoing substrate thoracoscopic catheter ablation.

Primary Outcome Measures: HD-grid electrograms, EGMs on HD-grid will be analyzed in detail by two physicians., During ablation
Validation of a Swiss German Language Test for Children
NCT Number: NCT06567613
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Hearing Loss
Interventions: DIAGNOSTIC_TEST: Speech test
Sponsor: Insel Gruppe AG, University Hospital Bern
Collaborators: University Hospital, Basel, Switzerland|University Hospital, Zürich|Luzerner Kantonsspital
Sex: ALL
Age: CHILD
Enrollment: 180
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-10-01
Completion Date: 2025-12-31
Locations: Inselspital Bern, Bern, 3010, Switzerland

Summary:
The aim of this study is to validate a Swiss German children's language test. Standard values for the speech intelligibility of Swiss German monosyllables and disyllables for children with normal hearing aged 4-6 years are recorded.

Primary Outcome Measures: Speech reception threshold for monosyllabic words, Speech Reception Threshold (SRT) measured in decibel sound pressure level (dB SPL), with lower scores indicating better hearing, Single visit at baseline|Speech reception threshold for bisyllabic words, Speech Reception Threshold (SRT) measured in decibel sound pressure level (dB SPL), with lower scores indicating better hearing, Single visit at baseline
Secondary Outcome Measures: Speech reception threshold in noise for monosyllabic words, Speech Reception Threshold (SRT) measured in decibel signal-to-noise ratio (dB SNR) with lower scores indicating better hearing, Single visit at baseline|Speech reception threshold in noise for bisyllabic words, Speech Reception Threshold (SRT) measured in decibel signal-to-noise ratio (dB SNR) with lower scores indicating better hearing, Single visit at baseline
Low-dose Gemcitabine and Cisplatin and PD-1/PD-L1 Antibody Therapy in Intrahepatic Cholangiocarcinoma
NCT Number: NCT06567600
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Intrahepatic Cholangiocarcinoma|Chemotherapy Effect|Immunotherapy
Interventions: DRUG: Low-dose Gemcitabine and Cisplatin Chemotherapy plus PD-1/PD-L1Antibody
Sponsor: Third Affiliated Hospital, Sun Yat-Sen University
Collaborators: Second Affiliated Hospital of Guangzhou Medical University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 43
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2028-12-31
Locations: The Third Affiliated Hospital of Sun Yat-Sen University, Guangzhou, Guangdong, China

Summary:
In this phase 2 study, researchers aimed to evaluate the efficacy and safety of low-dose gemcitabine and cisplatin chemotherapy and the immune checkpoint inhibitor PD-1/PD-L1 antibody in patients with advanced and unresectable intrahepatic cholangiocarcinoma.

Primary Outcome Measures: Objective Response Rate (ORR), ORR according to RECIST 1.1 using investigator assessment, 12 months
Secondary Outcome Measures: Incidence of adverse events, Rate of participants with treatment-related adverse events as assessed by CTCAE v4.0, 12 months|Deepness of response (DpR), DpR according to RECIST 1.1 using investigator assessment, 12 months|Disease control rate (DCR), DCR according to RECIST 1.1 using investigator assessment, 12 months|Overall Survival (OS), OS is defined as the time from date of combined theray start to the date of death from any cause or to the date of last follow-up if patients are alive, 36 months|Progression-free Survival (PFS), From the beginning date of combined therapy to the date of disease progression. PFS according to RECIST 1.1 using investigator assessment, 36 months
Dexmedtomodine Effect on Agitated Psychotic Patients Suffer COPD
NCT Number: NCT06567587
Status: ACTIVE_NOT_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Response of Agitated Patients to Dexmedetomidine
Interventions: DRUG: Dexmedetomidine|DEVICE: BIPAP
Sponsor: Tanta University
Collaborators: Laila Ahmed Abd-Elmotaleb El-Ahwal|Marwa Ahmed Abogabal
Sex: ALL
Age: ADULT
Enrollment: 70
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-10
Completion Date: 2024-11-10
Locations: Tanta, Tanta, State/Province:*, 0020, Egypt

Summary:
Many studies approved dexmedetomodine as a drug controlled agitation for psychotic patients and also for patients on non invasive ventilation.

So we study the same effect on agitated patients who are on non invasive ventilation and also suffer of psychosis as agitation become more aggressive than usual

Primary Outcome Measures: Primary outcome, failure rate of patients necessitates invasive ventilation after non-invasive ventilation., 6 months
Secondary Outcome Measures: Secondary outcome, Richmond agitation score.

• Effective doses of dexmedetomidine are needed to control agitation., 6 months
Treatment of Mandibular Bone Cyst by Navigation and Endoscopy
NCT Number: NCT06567535
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Jaw Cysts
Interventions: PROCEDURE: Navigation and endoscopy
Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 122
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-20
Completion Date: 2026-12-30
Locations: WangYan, Guangzhou, Guangdong, 510000, China

Summary:
In this study, with the assistance of endoscopic technology and intraoperative navigation technology, the removal and curettage of large odontogenic jaw cyst occurred in the mandible were performed to reduce the rate of postoperative nerve injury. In this study, the investigators compared the efficacy of traditional extraction and curettage with endoscopic navigation assistance in the treatment of giant mandibular bone cysts. In this study, the rate of inferior alveolar nerve injury 1 month after surgery was taken as the main outcome index, and the recurrence rate 1 year after surgery was taken as the secondary outcome index, to explore whether endoscopic combined with intraoperative navigation-assisted treatment of giant mandibular bone cyst could achieve lower postoperative nerve injury rate and postoperative recurrence rate.

Primary Outcome Measures: Rate of inferior alveolar nerve injury at one month postoperatively, Rate of inferior alveolar nerve injury at one month postoperatively, one month
Secondary Outcome Measures: Recurrence rate one year after surgery, Recurrence rate one year after surgery, one year
Effects of a Virtual Reality Intervention on Mental Health Outcomes and Academic Success in Physical Therapy Students
NCT Number: NCT06567496
Status: ENROLLING_BY_INVITATION
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Mental Stress|Anxiety|Depression|Satisfaction
Interventions: OTHER: First Resort
Sponsor: Belmont University
Collaborators: BehaVR LLC
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-16
Completion Date: 2025-01-15
Locations: Belmont University, Nashville, Tennessee, 37212, United States

Summary:
Exploring the impact of a virtual reality program, First Resort on graduate physical therapy student wellness and academic success.

Primary Outcome Measures: Patient Health Questionnaire-8, Self-reported questionnaire most frequently used worldwide for the screening and severity assessment of depression, 8 weeks|General Anxiety Disorder-7, Self-reported questionnaire to measure or assess the severity of generalized anxiety disorder, 8 weeks|Perceived Stress Scale-10, Self-reported measure of global perceived stress, 8 weeks|Client Satisfaction Questionnaire-8, Self-reported questionnaire assessing satisfaction with the intervention, 8 weeks|Self-reported Cumulative Grade Point Average, Participants self-report the overall semester grade point average, 8 weeks|Qualitative feedback_survey, Self-reported survey questions about manageableness of time and value of experience with virtual reality, 8 weeks|Qualitative feedback_Focus groups, Qualitative feedback questions involving experience with first resort (Focus Group), 8 weeks
Secondary Outcome Measures: Patient Health Questionnaire-2, Self-reported questionnaire most frequently used worldwide for the screening and severity assessment of depression, 8 weeks|General Anxiety Disorder-2, Self-reported questionnaire to measure or assess the severity of generalized anxiety disorder, 8 weeks|Perceived Stress Scale-4, Self-reported measure of global perceived stress, 8 weeks|The exit survey included several questions about Life style factors, Participants will be asked about sleep and exercise behaviors throughout the study. They will also be asked if they had mental health support during the study, such as counseling or psychiatric care., 8 weeks
A Comparison of Protein-bound and Large Molecular Weight Uremic Toxin Removals With Novel Super High-flux Dialyzer Between Hemodialysis and High Volume Online HDF Modalities
NCT Number: NCT06567483
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Uremic; Toxemia
Interventions: DEVICE: ELISIO21HX
Sponsor: Chulalongkorn University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 16
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-05-01
Completion Date: 2024-03-01
Locations: Faculty of Medicine Chulalongkorn university, Pathum Wan, Bangkok, 10330, Thailand

Summary:
The goal of this prospective, randomized, crossover study is to study about using super high-flux dialyzer in the chronic hemodialysis patients.

The main questions aim to answer are the reduction ratio of protein bound uremic toxins

Participants will undergone the pre-dilution online hemodiafiltration and conventional hemodialysis for each 8 weeks followed by washout phase for 4 weeks.

Primary Outcome Measures: Protein bound uremic toxin reduction ratio (percent), The reduction ratio of indoxyl sulfate will be calculated as percent by pre and post dialysis data. The measurement will take place in the pre-dialysis of the first and the last time of intervention, 8 weeks
Secondary Outcome Measures: Beta2 microglobulin, kappa and lambda free light chain and urea reduction ratio (percent), The reduction ratio of the beta2 microglobulin, kappa and lambda free light chain and urea will be measure at the first and the last time of intervention by pre and post dialysis level., 8 weeks|Serum albumin and dialysate albumin loss, Serum albumin will be followed at the midweek pre-dialysis at the first and 8th weeks of intervention.

Dialysate albumin will also be assessed at the 1st and the 8th weeks., 8 weeks|Quality of life assessment in each group, Quality of life was assessed by the KDQOL36 questionnaire in each intervention, 8 weeks
A Study With CIT-013 in RA Patients
NCT Number: NCT06567470
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Rheumatoid Arthritis
Interventions: DRUG: CIT-013 low dose|DRUG: CIT-013 high dose|DRUG: Placebo
Sponsor: Citryll BV
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 150
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-11
Completion Date: 2027-07
Locations: UZ Leuven, Leuven, Belgium|Schwerpunktpraxis für Rheumatologie und Gastroenterologie, München, Germany|University of Szeged, Szeged, Hungary|Amsterdam UMC, Amsterdam, Netherlands|Radboud UMC, Nijmegen, Netherlands|Centrum Zdrowia Stołeczna 7, Białystok, Poland|Marqués de Valdecilla University Hospital, Santander, Spain

Summary:
The goal of this clinical trial is to learn if CIT-013 works to treat rheumatoid arthritis in adults. It will also learn about the safety of CIT-013. The main questions it aims to answer are:

Does CIT-013 lower the disease activity of RA patients? What medical problems do participants have when receiving CIT-013? Researchers will compare CIT-013 to a placebo (a look-alike substance that contains no drug) to see if CIT-013 works to treat the symptoms of RA.

Participants will:

Take receive CIT-013 or placebo every other week for 12 weeks Visit the clinic once every 2 weeks for checkups and tests Keep monitor their symptoms during this period

Primary Outcome Measures: The change in DAS28-CRP at week 12 compared to baseline, Efficacy of CIT-013, week 12
Secondary Outcome Measures: Incidence of TEAEs as assessed by CTCAE, Safety and tolerability of CIT-013, 12 weeks|Maximum Plasma Concentration of CIT-013 before doses, CIT-013 levels, 4, 8 and 12 weeks
Immunogenicity and Safety Study of Monovalent Omicron XBB.1.5 Vaccine as a Booster in Adults
NCT Number: NCT06567457
Status: WITHDRAWN
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: COVID-19
Interventions: BIOLOGICAL: SCB-2023B vaccine, a monovalent Omicron XBB.1.5 recombinant SARS-CoV-2 trimeric S-protein subunit vaccine for COVID-19|BIOLOGICAL: SCB-2019 vaccine, a monovalent wu-hu1 SARS-CoV-2 trimeric S-protein subunit vaccine for COVID-19
Sponsor: Clover Biopharmaceuticals AUS Pty Ltd
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 0
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2023-10
Completion Date: 2024-10

Summary:
The purpose of this study is to assess the immunogenicity and safety of SCB-2023B monovalent Omicron XBB.1.5 vaccine compared to the prototype SCB-2019 vaccine in participants previously vaccinated with 3 doses of inactivated COVID-19 vaccine ≥6 months prior to enrollment.

Primary Outcome Measures: GMT ratio, Demonstrate that SCB-2023B vaccine elicits an immune response superior to SCB-2019 for Omicron XBB.1.5, Day 15|Assess the reactogenicity of SCB-2023B vaccine compared to SCB-2019 vaccine, Proportion of participants with local and systemic AEs, Day 7|Assess the safety of SCB-2023B vaccine compared to SCB-2019 vaccine, Proportion of participants with unsolicited AEs, Day 29|Assess the safety of SCB-2023B vaccine compared to SCB-2019 vaccine, Proportion of participants with SAE, AEs leading to early termination from study, MAAEs, and AESIs, Up to 1 year post-vaccination
Secondary Outcome Measures: Non-inferiority of the Omicron XBB.1.5 immune response elicited by SCB-2023B vaccine versus SARS-CoV-2 Delta titers in a subset of naïve participants of the CLO-SCB-2019-003 clinical study (virus neutralization assay), GMT ratio, Day 15|GMTs, Geometric mean titers elicited by SCB-2023B vaccine and SCB-2019 vaccine by virus neutralization assay against Omicron XBB.1.5, Day 1, 15, 180|GMFRs, Geometric mean fold rise elicited by SCB-2023B vaccine and SCB-2019 vaccine by virus neutralization assay against Omicron XBB.1.5, Day 1, 15, 180|SCRs, Proportion of subjects with seroconversion by virus neutralization assay against Omicron XBB1.5, Day 1, 15, 180|Proportion of subjects with antibody titer >=LLOQ by virus neutralization assay against Omicron XBB1.5, Proportion of participants with antibody titer ≥ LLoQ, Day 1, 15, 180|GMTs, Geometric mean titers elicited by SCB-2023B vaccine and SCB-2019 vaccine by virus neutralization assay against new emergent SARS-CoV-2 strains, Day 1, 15|GMFRs, Geometric mean fold rise elicited by SCB-2023B vaccine and SCB-2019 vaccine by virus neutralization assay against new emergent SARS-CoV-2 strains, Day 1, 15|SCRs, Proportion of subjects with seroconversion by virus neutralization assay against new emergent SARS-CoV-2 strains, Day 1, 15|Proportion of subjects with antibody titer >=LLOQ, Proportion of participants with antibody titer ≥ LLoQ by virus neutralization assay against new emergent SARS-CoV-2 strains, Day 1, 15
Blood And Tears in Alzheimer's Disease
NCT Number: NCT06567431
Acronym: BAT-AD
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Neurodegenerative Diseases
Sponsor: Danish Dementia Research Centre
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 600
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-03-18
Completion Date: 2028-12-31
Locations: Danish Dementia Research Centre, Copenhagen, 2100, Denmark

Summary:
This study aims to investigate whether biomarkers of Alzheimer's disease can be found in tearfluid, as well as dried bloodspots in patients with Alzheimer's disease, other dementia diagnoses compared to controls.

Primary Outcome Measures: AD related biomarkers in tear fluid, Concentrations of AD biomarkers (AB42, AB40, Ptau217, NfL, GFAP) in tear fluid in the AD-group compared to non-AD and controls., Two years|AD related biomarkers in dry blod spots, Concentrations of AD biomarkers (AB42, AB40, Ptau217, NfL, GFAP) in dry blot spots in the AD-group compared to non-AD and controls., Two years
Secondary Outcome Measures: Testing dry blod spots at home, To test the feasability of dry blod spots card in a home setting - measuring concentrations of AD biomarkers in the blod cards performed at home compared to the card performed in the clinic., Two years
Derma Pen as Treatment of Gingivitis Induced by Orthodontics
NCT Number: NCT06567405
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Gingivitis|Orthodontic Appliance Complication
Interventions: PROCEDURE: mechanical periodontal treatment|DEVICE: Derma pen with topical ascorbic Acid
Sponsor: Safa Basiouny Alawy
Sex: ALL
Age: ADULT
Enrollment: 24
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-05-30
Completion Date: 2024-10
Locations: Tanta University, Tanta, 6624033, Egypt

Summary:
Although orthodontic therapy frequently improves tooth alignment and appearance, its problems with oral hygiene can make patients highly susceptible to gingivitis. After orthodontic treatment, gingivitis is a typical problem. New treatments that promote healing and decrease inflammation are needed. Ascorbic acid and Derma Pen used together have recently surfaced as a potentially effective therapy option for patients who seeking for periodontal therapy during and after orthodontic treatments.

Primary Outcome Measures: gingival index (GI), gingival index will be calibrated using William's probe approximately 1 to 2 mm to the margin of the gingiva at an angulation of 45 degree to document the gingival inflammation signs of the upper six anterior teeth. Each of the four surfaces of the anterior teeth (buccal, lingual, mesial, and distal) will be given a score from 0 to 3 and then areas were added and divided by four to give the accurate GI of each tooth.

Score 0 = No signs of inflammation, bleeding, or swelling. Score 1= Presence of signs of mild inflammation, slight edema, and color change but no bleeding.

Score 2 = Presence of moderate inflammation, redness, swelling, and bleeding on probing.

Score 3 = Presence of severe inflammation, marked redness, edema, and spontaneous bleeding., one month
Secondary Outcome Measures: Plaque Index (PI), PI will be measured to record soft deposit accumulations on the upper six anterior teeth. Each of the four surfaces of the anterior teeth (buccal, lingual, mesial, and distal) will be given a score from 0 to 3 and then areas were added and divided by four to give the accurate PI of each tooth.

Sore 0 = No plaque. Score 1 = A film of plaque adhering to the free gingival margin and adjacent area of the tooth. The plaque may be seen in situ only after using the probe on the tooth surface (not seen by the naked eye).

Score 2 = Moderate accumulation of soft deposits within the gingival pocket, or the tooth and gingival margin, which can be seen with the naked eye.

Score 3 = Abundance of soft deposits within the gingival pocket and/or on the tooth and gingival margin that covers the interdental areas., one month
A Study to Evaluate the Mass Balance of [14C] HRS-5965 in Healthy Adult Male Volunteers
NCT Number: NCT06567392
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Complement Mediated Primary or Secondary Glomerular Diseases
Interventions: DRUG: [14C] HRS-5965
Sponsor: Chengdu Suncadia Medicine Co., Ltd.
Sex: MALE
Age: ADULT
Enrollment: 8
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-08-28
Completion Date: 2024-09-30
Locations: The First Affiliated Hospital Of Shandong First Medical University（Shandong Provincial Qianfoshan Hospital）, Jinan, Shandong, 250014, China

Summary:
Evaluate the Mass Balance of \[14C\] HRS-5965 in Healthy Adult Volunteers.

Primary Outcome Measures: Total radioactive recovery rate in urine and feces at each time interval, 0-240 hours|Cumulative total radioactive recovery rate in urine and feces, 0-240 hours|3. Percentage of parent drug and its metabolites in plasma as a percentage of total radioactive exposure (%AUC), 0-192 hours|Percentage of parent drug and its metabolites in urine and feces as a percentage of administered dose (%Dose), 0-240 hours|Radioactivity Tmax, 0-192 hours|Radioactivity Cmax, 0-192 hours|Radioactivity AUC, 0-192 hours|Radioactivity t1/2, 0-192 hours|Radioactivity CL/F, 0-192 hours|Radioactivity Vz/F, 0-192 hours|Total radioactivity ratio for blood/plasma, 0-96 hours
Secondary Outcome Measures: Plasma HRS-5965: Tmax, 0-192 hours|Plasma HRS-5965: Cmax, 0-192 hours|Plasma HRS-5965: AUC, 0-192 hours|Plasma HRS-5965: t1/2, 0-192 hours|Plasma HRS-5965: CL/F, 0-192 hours|Plasma HRS-5965: Vz/F, 0-192 hours|Plasma HRS-5965: λz, 0-192 hours|AEs and SAEs, 0-11 days
Myocardial Work Evaluation in Patients With PAH
NCT Number: NCT06567379
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Pulmonary Arterial Hypertension
Sponsor: Central Hospital, Nancy, France
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-25
Completion Date: 2024-09-30
Locations: Valentin, Nancy, France

Summary:
Right ventricular function is a key determinant of survival in patients with pulmonary arterial hypertension, with right heart failure being the leading cause of death. ERS/ESC guidelines recommend evaluating RV function at diagnosis and at first reevaluation under treatment to estimate the one-year mortality risk. However, few RV function markers address both systolic function and afterload. Noninvasive myocardial work is a promising new tool that incorporates systolic function and its afterload into global longitudinal strain. Initially developed for the left ventricle, it can be adapted for the RV using pressure-strain loops. The article aims to evaluate the association of RV myocardial work parameters with the estimate one-year mortality in patients with PAH.

This retrospective study will include patients diagnosed with PAH with transthoracic echocardiography and right heart catheterization within 48 hours at diagnosis and first reevaluation. Patients with unanalyzable echocardiography data will be excluded.

Primary Outcome Measures: One year risk mortality, According to four model strata, estimation of one year mortality risk (low, intermediate-low, intermediate-high or high risk), six months
CAR T-cell Therapy in Combination With Glofitamab for Relapsed/Refractory Large B-Cell Lymphoma With High-Risk Prognostic Factors
NCT Number: NCT06567366
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Large B-cell Lymphoma
Interventions: BIOLOGICAL: CAR T-cell therapy|DRUG: Glofitamab|DRUG: Obinutuzumab
Sponsor: Ruijin Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 45
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2027-09
Locations: Shanghai Ruijin Hospital, Shanghai, China

Summary:
The aim of this study is to evaluate the efficacy and safety of CAR T-cell therapy in combination with glofitamab for the treatment of relapsed/refractory large B-cell lymphoma with high-risk prognostic factors.

Primary Outcome Measures: Complete Response (CR) Rate, CR rate is defined as the percentage of participants achieving CR per the Lugano Classification as determined by study investigators, Up to 2 years
Secondary Outcome Measures: Objective Response Rate (ORR), ORR is defined as the percentage of participants achieving either CR or partial response (PR) per the Lugano Classification as determined by study investigators, Up to 2 years|Duration of Response (DoR), DoR is defined only for participants who experience an objective response and is the time from the first objective response to disease progression or death from any cause., Up to 2 years|Progression-Free Survival (PFS), PFS is defined as the time from leukapheresis to first documented progression or death from any cause., Up to 2 years|Overall Survival (OS), OS is defined as the time from leukapheresis to death from any cause., Up to 2 years|Percentage of Participants With Treatment Emergent Adverse Events (TEAEs), Assessed by CTCAE criteria v5 and ASTCT 2019 criteria for CRS/ICANS adverse events., Up to 2 years
A Multi-mode Thermophysical Immunotherapy Study for Breast Cancer Liver Metastases
NCT Number: NCT06567353
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Breast Neoplasms|Liver Neoplasms|Metastasis
Interventions: DEVICE: Multi-mode tumor treatment system|DEVICE: Radiofrequency ablation therapeutic apparatus
Sponsor: Ruijin Hospital
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 10
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2027-12

Summary:
This is a single-center, parallel-controlled clinical study designed to evaluate the safety, efficacy and impact on systemic anti-tumor immunity of a multi-mode integrated ablation system for the treatment of breast cancer liver metastases.

Primary Outcome Measures: Anti-tumor immune response, The anti-tumor immune response refers to the effect and mechanism by which multi-mode ablation activates systemic persistent specific anti-tumor immunity, thereby inhibiting tumor metastasis and recurrence., max 24 months
Secondary Outcome Measures: 6-Month Local Control Rate, 6-month local control rate (LCR) refers to the proportion of patients in whom the primary tumor site lesions are completely suppressed after treatment among all treated patients six months after the start of treatment., 6 months|6-Month Progression-Free Survival, 6-month progression-free survival (6-month PFS) refers to the percentage of patients who are alive without tumor progression or metastasis six months after the start of treatment., 6 months|1-Year Progression-Free Survival, 1-year progression-free survival (1-year PFS) refers to the percentage of patients who are alive without tumor progression or metastasis one year after the start of treatment., 1 year|1-Year Overall Survival, 1-year overall survival (1-year OS) refers to the percentage of patients who are still alive one year after the start of treatment., 1 year
A Study to Learn How the Study Medicine Danuglipron is Taken Up Into the Blood and If Danuglipron Changes How the Body Processes Other Study Medicines (Atorvastatin and Rosuvastatin) in Healthy Adults Who Are Overweight or Obese
NCT Number: NCT06567327
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Obesity
Interventions: DRUG: Danuglipron|DRUG: Atorvastatin|DRUG: Rosuvastatin
Sponsor: Pfizer
Sex: ALL
Age: ADULT
Enrollment: 40
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-08-27
Completion Date: 2025-03-31

Summary:
The purpose of this study is to learn the following about the study medicine, danuglipron, after multiple days of dosing in healthy adults who are overweight or obese:

* how the study medicine, danuglipron, is taken up into the blood
* if the study medicine, danuglipron, changes how the body processes other study medicines (Atorvastatin and Rosuvastatin)
* about the safety and tolerability of danuglipron

The study will take place in 2 Cohorts (groups). The total number of weeks of the study is about 23 (about 6 months) for Cohort 1 and 22 weeks (about 5.5 months) for Cohort 2.

Primary Outcome Measures: Steady-state area under the concentration-time profile from time zero to 24 hours (AUC24) for danuglipron, Predose to 24 hours post danuglipron administration|Steady-state maximum observed concentration (Cmax) for danuglipron, Predose to 24 hours post danuglipron administration|Steady-state time to reach maximum observed concentration (Tmax) for danuglipron, Predose to 24 hours post danuglipron administration|Area under the concentration-time curve from time zero extrapolated to infinite time (AUCinf), as data permit, for atorvastatin, Predose to 72 hours post atorvastatin administration|Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast) for atorvastatin (only if AUCinf is not reportable), Predose to 72 hours post atorvastatin administration|Area under the concentration-time curve from time zero extrapolated to infinite time (AUCinf), as data permit, for rosuvastatin, Predose to 96 hours post rosuvastatin administration|Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast) for rosuvastatin (only if AUCinf is not reportable), Predose to 96 hours post rosuvastatin administration
Secondary Outcome Measures: Number of participants reporting Treatment Emergent Adverse Events (TEAEs), From baseline up to 28-35 days post last dose taken|Number of participants reporting clinically significant clinical laboratory abnormalities, From baseline up to 28-35 days post last dose taken|Number of participants reporting clinically significant vital sign abnormalities, From baseline up to 28-35 days post last dose taken|Change from baseline in body weight, From baseline up to 28-35 days post last dose taken|Number of participants reporting clinically significant changes ECG abnormalities, From baseline up to 28-35 days post last dose taken
Phase 2 Study of Ivonescimab in Patients With Cutaneous Squamous Cell Carcinoma
NCT Number: NCT06567314
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Cutaneous Squamous Cell Carcinoma
Interventions: DRUG: Ivonescimab
Sponsor: M.D. Anderson Cancer Center
Collaborators: Summit Therapeutics
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 24
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2025-02-28
Completion Date: 2030-09-01
Locations: MD Anderson Cancer Center, Houston, Texas, 77030, United States

Summary:
To learn if ivonescimab can help to control advanced cSCC. The safety and effects of ivonescimab will also be studied.

Primary Outcome Measures: Safety and adverse events (AEs), Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0, Through study completion; an average of 1 year.
Extracorporeal Shockwave Versus Phonophoresis Using Chitosan-Nanoparticles Gel on Functional and Anatomical Changes Detected With Artificial Intelligence Based Texture Analysis Algorithm in Knee Osteoarthritis Patients: A Double Blind Randomized Controlled Trial
NCT Number: NCT06567301
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Knee Osteoarthritis|Chitosan Nanoparticles Gel|Artificial Intelligence Texture Analysis Bases Algorithm|Subchondral Bone Changes (Anatomical Changes)|Extracorporeal Shockwave
Interventions: COMBINATION_PRODUCT: Ultrasound therapy combined with Chitosan nanoparticles gel
Sponsor: Cairo University
Sex: ALL
Age: ADULT
Enrollment: 120
Study Design: Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: DIAGNOSTIC
Start Date: 2023-10-25
Completion Date: 2025-06-30
Locations: Physical Therapy College - Cairo University, Giza, El Dokki, 12613, Egypt|Physical therapy college - Cairo University, Giza, EL Doqqi, 12613, Egypt

Summary:
A parallel double blinded randomized controlled clinical trial (RCT) with a 1:1:1 allocation will be conducted in an orthopedic clinic in Cairo and Giza Governments - Egypt.

This RCT will evaluate the pain reduction, self-reported functional improvement, physical functional and anatomical improvement following the application of phonophoresis using chitosan-nanoparticles gel, ECSW therapy and traditional exercises compared to each other.

The treatment period will last for 4 weeks with a total of (12 sessions/ 3 sessions per week for the application of phonophoresis using chitosan-nanoparticles gel and traditional exercises program) and (5 sessions/ 1 every week for the application of ECSWT). The participants will be assessed at two different time-points (before-after treatment) with a sample size of 40 patients in each group (3 groups)

Primary Outcome Measures: Anatomical improvement, subchondral bone improvement following the application of Phonophoresis using chitosan-nanoparticles gel, ECSW therapy and assessed by Artificial intelligence based texture analysis algorithm, one month
Secondary Outcome Measures: level of knee pain, by VAS, one month
Other Outcome Measures: Physical functional assessment, by TUG, one month|Self-reported functional assessment, by the (ArWOMAC) Index for measurement of perceived health and physical function, one month
Effect of Spencer Muscle Energy Technique on Pain in Diabetic Stiff Shoulder
NCT Number: NCT06567288
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Frozen Shoulder
Interventions: PROCEDURE: spencer mscle energy technique
Sponsor: Cairo University
Sex: FEMALE
Age: ADULT
Enrollment: 30
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-10-01
Completion Date: 2024-12-01

Summary:
Stiff shoulder is a painful and severely debilitating condition. The inflammatory contracture of the glenohumeral joint capsule in stiff shoulder restricts both active and passive range of motion, with loss of external rotation being especially characteristic of this condition (Dyer et al., 2023). Stiff shoulder is clinically described by the continuing onset of shoulder pain and advanced exacerbation of the shoulder joint leading to exertion in the higher extremity activity, significant disability, and functional restrictions. The most common symptom of a stiff shoulder is night pain, resulting in sleep impediment that leads to one-sided sleep on the uninfected shoulder (Mao et al., 2022).

Spencer technique is a standardized series of treatments with broad application to diagnose, treat and establish prognosis for restricted mobility in shoulder. It was developed by Spencer in 1961. It is a multistep technique that combines Spencer's positioning, sequencing, slow stretching of the shoulder complex within pain-free limits done by physical therapist while incorporating muscular energy with post-isometric contraction and relaxation (Babu And Putcha., 2022).

Primary Outcome Measures: pain pressure threshold algometry, Algometers are devices that can be used to identify the pressure and/or force eliciting a pressure-pain threshold., will be measured at baseline, and it will be measured after eight weeks|Visual Analogue Scale (VAS), was used to assess the severity of pain before and after treatment for both groups, will be measured at baseline, and it will be measured after eight weeks
Secondary Outcome Measures: goniometer, measures the available range of motion, will be measured at baseline, and it will be measured after eight weeks|SPADI (shoulder pain and disability index)., It is a self-revealed measure created to assess shoulder pathological conditions, will be measured at baseline, and it will be measured after eight weeks
Comparison Between Serratus Anterior Plane Block and Erector Spinae Plane Block in Coarctectomy
NCT Number: NCT06567275
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Aortic Coarctation
Interventions: PROCEDURE: block
Sponsor: Cairo University
Sex: ALL
Age: CHILD
Enrollment: 28
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-08
Completion Date: 2025-01
Locations: Abu Elreish Hospital, Cairo, Egypt

Summary:
comparison between the perioperative analgesic efficacy and any side effects of U/S guided serratus anterior plane block versus the erector spinae plane block in pediatric patients undergoing aortic coarctectomy.

Primary Outcome Measures: Total intraoperative fentanyl consumption by mcg/kg., calculating the total dose of fentanyl used intraoperatively, Pain score assessment every 2 hours for the first 24 hours post-operatively by FLACC score
Secondary Outcome Measures: Time (in minutes) to 1st rescue analgesia (morphine), estimating the time of the need for 1st dose of morphine, 1st 24 hours postoperatively
Compare CAD/CAM Metallic RPD to Conventional Metallic RPD in Terms of Oral Health Related Quality of Life
NCT Number: NCT06567262
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Partial Edentulism Class 3
Interventions: DEVICE: CAD/CAM metallic removable partial denture|DEVICE: Conventional metallic removable partial denture
Sponsor: Cairo University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 19
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-10
Completion Date: 2025-03

Summary:
Patients will be randomised to receive CAD/CAM metallic removable partial denture (RPD) followed by Conventional metallic RPD (Group A), or the opposite sequence (Group B), with a 3-month wear duration for each denture and washout period for one week. Patients will be recalled at base line and 3 months following prosthetic insertion to evaluate Oral health related quality of life. It is hypothesized that removable partial dentures with CAD/CAM metallic RPD frameworks would improve Oral health related quality of life than those with Conventional metallic RPD frameworks.

Primary Outcome Measures: Oral health related quality of life, Oral health related quality of life will be measured by a valid and reliable questionnaire which is Oral health impact profile questionnaire (OHIP) before RPD insertion then after RPD insertion with one and 3 months for both groups. It consists of 5 questions representing the four suggested dimensions: Oral Function, Orofacial Pain, Orofacial Appearance and Psychosocial Impact. Questions were made on a 5-point Likert scale (0 = never; 1 = hardly ever; 2 = occasionally; 3 = fairly often; and 4 = very often)., 3 months
Secondary Outcome Measures: Cost effectiveness, Cost effectiveness analysis - The incremental cost-effectiveness ratio (ICER) will be calculated using the following formula: ICER = direct cost difference / outcome score difference between CAD/CAM metallic RPD and Conventional metallic RPD

- ICER indicates an additional cost that needs to increase extra one unit in each outcome measure with CAD/CAM metallic RPD comparing to Conventional metallic RPD treatment, 3 months
E4D Compare Adapted to Preclinical Endodontics
NCT Number: NCT06567236
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Self-Assessment|Self-Perception
Sponsor: Texas A&M University
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 59
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: OTHER
Start Date: 2023-02-27
Completion Date: 2023-05-08

Summary:
Based on pilot study's promising results, we decided to further investigate the impact of adapting Planmeca Romexis Compare software to evaluate pulpal access preparations on second-year dental students' technical performance, self-evaluation skills and opinions. No educational records, grades, coursework, or any other assignments that are completed as part of the regular class will be analyzed as part of this study.

Primary Outcome Measures: Self-assessment - traditional method vs traditional method plus 3D software method, Compare self-assessment after traditional method only and with extra 3D software method, baseline, 2 weeks, 4 weeks, 5 weeks and 7 weeks|Grading - traditional method vs traditional method plus 3D software method, Compare technical skills after traditional method only and with extra 3D software method, baseline, 2 weeks, 4 weeks, 5 weeks and 7 weeks
Secondary Outcome Measures: Grading - traditional/visual grading vs 3D software grading, Compare traditional/visual grading to 3D software grading using different tolerance levels, baseline, 2 weeks, 4 weeks, 5 weeks and 7 weeks
Effectiveness of WBV Versus RAS on Spasticity, Balance, and Lower Limb Motor Function on Hemiplegic Stroke Patients
NCT Number: NCT06567223
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Stroke
Interventions: PROCEDURE: Vibration Therapy|COMBINATION_PRODUCT: Rhythmic auditory stimulation therapy.
Sponsor: Superior University
Sex: ALL
Age: ADULT
Enrollment: 104
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2023-10-01
Completion Date: 2024-09-30
Locations: Chaudary Muhammad Akram Teaching Hospital, Azra Naheed Medical College, Superior University, Lahore, Punjab, Pakistan|Sehat Medical Complex, Hanjerwal, Lahore, Punjab, Pakistan

Summary:
This study investigates the effectiveness of whole-body vibration (WBV) versus rhythmic auditory stimulation (RAS) on spasticity, balance, and lower limb motor function in hemiplegic stroke patients. The objective was to compare the two interventions to determine which provides greater benefits in stroke rehabilitation. Hemiplegic stroke patients were randomly assigned to either the WBV group, receiving whole-body vibration therapy, or the RAS group, undergoing rhythmic auditory stimulation sessions.

Primary Outcome Measures: Modified Ashworth Scale, Modified Ashworth Scale is a scale which is used to assess spasticity in a patient. It is range from 0 to 4 where 0 shows no muscle tone with no range to 4 which shows maximum muscle tone with full range.., 12 Months|Berg balance scale, Balance was measured by using BBS which was created in 1989 to measure balance in the older people. The Berg balance scale 27 assesses practical balance performance on 14 things normal to everyday life. The scale comprises of 14 items, scored from 0 to 4, which are added to make an all-out score somewhere in the range of 0 and 56; a higher score shows better balance, 12 months|Fugl-Meyer Assessment (FMA), Fugl-Meyer Assessment (FMA) for Lower Limb. In order to assess the lower extremity motor control fugal Meyer assessment test which is a strokes specific test was used to assess the motor function balance and sensation in stroke patients. Its scoring is through 3 point ordinal scale where 2 is performed fully and 1 is performed partially. It has a maximum score of 34, 12 months