pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Survival and Success Rates of External- and Internal- Connection Dental Implants Placed Within the United Kingdom Armed Forces.
NCT Number: NCT06554080
Status: ACTIVE_NOT_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Dental Implant Failed|Tooth Loss|Implant Complication
Interventions: PROCEDURE: Platform-switched implant placement|PROCEDURE: Platform-matched implant placement
Sponsor: Defence Primary Health Care, UK
Collaborators: University of Birmingham
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 438
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-05-02
Completion Date: 2025-05-02
Locations: Defence Centre of Rehabiliative Dentistry, Aldershot, Surrey, GU11 2LG, United Kingdom

Summary:
This is a retrospective cohort study that evaluates the survival (Outcome 1) of dental implant systems (external connection (Cohort 1) and internal connection (Cohort 2) and the effectiveness of maintaining crestal bone levels (Outcome 2), placed within United Kingdom Armed Forces personnel. The secondary objectives include: assessment of block bone grafting on outcome, assessment of restoration (bridge vs crown on outcome) and assessment of placement technique (immediate, early, delayed placement). Inclusion criteria: all military patients that received dental implants since 2014-2024. Exclusion criteria: military patients that have not received radiographic review or follow-up of the dental implant or who have left service or have a follow-up that is less than 12-months post placement of the dental implant..

Primary Outcome Measures: Dental Implant Survival (presence of implant at point of review), Null hypothesis: No difference in dental implant survival between the 2 cohorts (Platform-Matched vs Platform-Switched dental implant/ abutment interfaces). This is a binary outcome of either implant still present or implant absent at time of review., Minimum time frame for inclusion is 12 months
Secondary Outcome Measures: Dental Implant Crestal Bone Levels, Null hypothesis: There is no difference in the crestal bone levels between the 2 cohorts (Platform-Matched vs Platform-Switched dental implant/ abutment interfaces). This outcome is measured radiographically using a software programme to determine changes in bone levels. Outcome is measured in mm., Minimum time frame for inclusion is 12 months
Effects of tDCS and VNS on Postoperative Analgesia
NCT Number: NCT06554067
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Acute Postoperative Pain
Interventions: DEVICE: Active transcranial direct current stimulation|DEVICE: Active vagus nerve stimulation|OTHER: Sham transcranial direct current stimulation|OTHER: Sham vagus nerve stimulation
Sponsor: Columbia University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2026-08

Summary:
This study seeks to evaluate the efficacy of transcranial direct current stimulation (tDCS) and Afferent Vagus nerve simulation (VNS) in treating acute postoperative pain of patients in the post-anesthesia care unit after general surgery.

Study outcomes will include changes in pain levels and vital signs. For patients who are admitted after surgery, opioid consumption in the 24 hours after surgery and time from surgery to discharge are recorded as secondary outcomes.

Patients will be divided in the following comparison groups:

* Group +/+ will receive ten minutes of active tDCS followed by ten minutes of active VNS.
* Group +/- will receive ten minutes of active tDCS followed by ten minutes of sham VNS.
* Group -/+ will receive ten minutes of sham tDCS followed by ten minutes of active VNS.
* Group -/- will receive ten minutes of sham tDCS followed by ten minutes of sham VNS.

Primary Outcome Measures: Pain levels using Numerical Rating Scale, Numerical Rating Scale (NRS) from 0-10. 0 being no pain, and 10 being the worse pain patient has experienced., Immediately before the intervention and immediately after the intervention.|Pain levels using the Verbal Rating Scale, Verbal Rating Scale (VRS) distinguishing between no pain, mild pain, moderate pain, and severe pain., Immediately before the intervention and immediately after the intervention.
Secondary Outcome Measures: Vital Signs: Blood pressure., Patients at the PACU are under continuous monitoring of vital signs. We will collect the values of the blood pressure in mmHg. A high score (higher than 130/80) will indicate a bad outcome., Immediately before and immediately after intervention. Then, every 5 minutes until one hour after the intervention.|Vital Signs: Heart rate, Patients at the PACU are under continuous monitoring of vital signs. We will collect the values of the heart rate before the intervention and after. A result higher than what is physiologic normal (100) will indicate a bad outcome., Immediately before and immediately after intervention. Then, every 5 minutes until one hour after the intervention.|Opioid consumption, Patients that stay in hospital after surgery will be evaluated for opioid consumption from medical record., 24 hours after surgery|Time from surgery to discharge, Investigator will measure how long does the patient stay in the hospital after surgery in number of days., From the date of the patient's surgery until the day of the discharge, up to 2 month.
A Study of GZR18 Tablet in Chinese Healthy Subjects
NCT Number: NCT06554054
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: GZR18
Sponsor: Gan and Lee Pharmaceuticals, USA
Sex: ALL
Age: ADULT
Enrollment: 92
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-04-01
Completion Date: 2024-12-09
Locations: Study Site 01, Beijing, China

Summary:
The aim of the trial is to investigate the the bioavailability, pharmacokinetics, pharmacodynamics, safety and tolerance of single and multiple doses of GZR18 tablet in healthy subjects.

Primary Outcome Measures: AE and SAE, Incidence of Adverse Events and Severe Adverse Events, 22 days and 35 days|Relative bioavailability of GZR18 tablet, Fr =AUC0-t(GZR18 tablets)/AUC0-t(GZR18 injection)×100%, 22 days and 35 days|ADA and NAb, Anti-Drug Antibody (ADA) and Neutralizing Antibody (Nab), 22 days and 35 days
Secondary Outcome Measures: Cmax, Maximum plasma drug concentration, 22 days and 35 days|AUC0-t, Area under the curve from 0 through the time of the last accurately measurable concentration, 22 days and 35 days|AUC0-24h, Area under the curve from 0 h to 24 hours, 22 days and 35 days
Tislelizumab and Induction Chemotherapy for Larynx Preservation in Resectable Advanced Laryngeal/Hypopharyngeal Cancer
NCT Number: NCT06554028
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Laryngeal Cancer|Hypopharynx Cancer|Laryngeal Neoplasms
Interventions: DRUG: chemotherapy TP regimen combined with Tislelizumab
Sponsor: Henan Cancer Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 46
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2027-12
Locations: Henan Cancer Hospital, Zhengzhou, Henan, 450000, China

Summary:
This study is a prospective, single-arm, single-center, phase II study. The goal of this clinical trial is to explore the therapeutic value of the treatment model of "tislelizumab combined with chemotherapy followed by radiotherapy/adaptive surgery" on larynx Preservation of locally advanced hypopharyngeal cancer and laryngeal cancer.

Primary Outcome Measures: Laryngeal preservation rate at 3 months after radiotherapy, defined as the absence of any residual disease that would justify salvage total laryngectomy, 3-month post-radiotherapy
Secondary Outcome Measures: Objective response rate after induction chemoimmunotherapy, 2 weeks after the 3th cycle of induction therapy, 2 weeks after the end of cycle 3 of induction therapy|Overall survival rate at 1 year, Overall survival rate at 1 year, One year post-radiotherapy|Laryngeal preservation rate at 1 year after radiotherapy, defined as the absence of any residual disease that would justify salvage total laryngectomy, 1 year post-radiotherapy|Progression-free survival rate at 1 year, Progression-free survival rate at 1 year, One year post-radiotherapy|Pathological complete response rate of the patients receiving surgical resection, Pathological complete response rate of the patients receiving surgical resection, evaluated by experienced pathologists, Within 3 weeks after surgery|Overall survival rate at 2 year, Overall survival rate at 2 year, Two year post-radiotherapy|Progression-free survival rate at 2 year, Progression-free survival rate at 2 year, Two year post-radiotherapy|Laryngeal Preservation rate at 2 year, Two year post-radiotherapy, Laryngeal Preservation rate at 2 year|Adverse Effect, Adverse Effect, evaluated by CTCAE 4.0.03, One year post-radiotherapy|Major pathologic response rate of the patients receiving surgical resection, Major pathologic response rate, defined as no more than 10% of residual viable tumor, evaluated by experienced pathologists, Within 3 weeks after surgery
Prospective Longitudinal Study of Heylo™ for People Living With a Stoma
NCT Number: NCT06554015
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Stoma Ileostomy
Sponsor: Coloplast A/S
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-01
Completion Date: 2027-07-02
Locations: Coloplast A/S, Humlebæk, Denmark

Summary:
This study aims to longitudinally evaluate the usage and long-term benefits of the CE-marked device, Heylo™, a digital leakage notification system for people with intestinal stomas. The system, which includes a smartphone application, an adhesive sensor layer, and a Bluetooth transmitter, notifies users of changes in their baseplate status, potentially reducing stoma effluent leakage and improving quality of life. The physical Heylo™ device, is part of the Coloplast Charter telehealth service.

Primary Outcome Measures: Primary endpoint, Stoma-related QoL measured by the Emotional Leakage Impact score (domain 1 of OLI) at baseline (0 months), 6, 9 and 12 months, one year
Mandibular Splint vs Botox Injection in Lateral Pterygoid on Cervical Muscle Activity in Patients With Temporomandibular Disorders
NCT Number: NCT06553950
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Mandibular Splint|Botox|Lateral Pterygoid|Cervical Muscle Activity|Temporomandibular Disorders
Interventions: DRUG: Botox injection|DRUG: Mandibular stabilization splint|DRUG: Muscle relaxant
Sponsor: Cairo University
Sex: ALL
Age: ADULT
Enrollment: 33
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-14
Completion Date: 2025-02-01
Locations: Cairo University, Cairo, 11796, Egypt

Summary:
The study aims to compere mandibular splint versus botox injection in lateral pterygoid on cervical muscle activity in patients with temporomandibular disorders

Primary Outcome Measures: Muscle activity of upper trapizieus and sternocleidomastoid, Muscle activity of upper trapizieus and sternocleidomastoid will be recorded before and after injection for 3 months by neurosoft Electromyography, After injection for 3 months.
Secondary Outcome Measures: Amplitude of muscle activity, Amplitude of muscle activity will be recorded before and after injection for 3 months by neurosoft Electromyography., After injection for 3 months.|Root mean square of muscle activity, Root mean square of muscle activity will be recorded before and after injection for 3 months by neurosoft Electromyography., After injection for 3 months.
Bioequivalence Study of Macitentan and Tadalafil Film-coated Tablets 10 mg/40 mg and 'PrOpsynvi®' Macitentan and Tadalafil Film-coated Tablets 10 mg/40 mg
NCT Number: NCT06553937
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: PAH
Interventions: DRUG: Macitentan and Tadalafil|DRUG: PrOpsynvi® Film-Coated Tablets
Sponsor: Humanis Saglık Anonim Sirketi
Sex: ALL
Age: ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-05-10
Completion Date: 2024-07-31
Locations: Cliantha Research Limited, Ahmedabad, Gujarat, 382210, India

Summary:
Single dose oral bioequivalence study of Macitentan and Tadalafil film-coated tablets 10 mg/40 mg and 'PrOpsynvi®' Macitentan and Tadalafil film-coated tablets 10 mg/40 mg in healthy adult male subjects under fed conditions.

Primary Outcome Measures: Maximum concentration obtained (Cmax), two-sided 90% CI for the test to reference ratio of the population means is within 80.00 - 125.00% for each of the Ln-transformed data Cmax, 72 hours|AUC from time 0 to last collection time t (AUC0-t), two-sided 90% CI for the test to reference ratio of the population means is within 80.00 - 125.00% for each of the Ln-transformed data AUC0-t, 72 hours
Secondary Outcome Measures: AUC from time 0 to infinity (AUCt-∞), Descriptive Statistics, 72 hours|Time to reach maximum concentration Cmax (Tmax), Descriptive Statistics, 72 hours
Macitentan and Tadalafil Film-coated Tablets 10 mg/40 mg and 'PrOpsynvi®' Macitentan and Tadalafil Film-coated Tablets 10 mg/40 mg
NCT Number: NCT06553924
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: PAH
Interventions: DRUG: Macitentan and Tadalafil film-coated tablets|DRUG: PrOpsynvi® macitentan and tadalafil film-coated tablets
Sponsor: Humanis Saglık Anonim Sirketi
Sex: ALL
Age: ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-05-14
Completion Date: 2024-08-08
Locations: Cliantha Research Limited, Ahmedabad, Gujarat, 382210, India

Summary:
Single dose oral bioequivalence study of Macitentan and Tadalafil film-coated tablets 10 mg/40 mg and 'PrOpsynvi®' Macitentan and Tadalafil film-coated tablets 10 mg/40 mg in healthy adult male subjects under fasting conditions.

Primary Outcome Measures: Maximum concentration obtained (Cmax), two-sided 90% CI for the test to reference ratio of the population means is within 80.00 - 125.00% for each of the Ln-transformed data Cmax, 72 hours|AUC from time 0 to last collection time t (AUC0-t), two-sided 90% CI for the test to reference ratio of the population means is within 80.00 - 125.00% for each of the Ln-transformed data AUC0-t, 72 hours
Secondary Outcome Measures: AUC from time 0 to infinity (AUCt-∞), Descriptive Statistics, 72 hours|Time to reach maximum concentration Cmax (Tmax), Descriptive Statistics, 72 hours
Exploring the Application Efficacy of Artificial Intelligence (AI) Diagnostic Tools in Medical Imaging (MI) of Respiratory(R) Infectious (I) Disease (D)
NCT Number: NCT06553911
Acronym: AI-MIRID
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Respiratory Infectious Diseases|Artificial Intelligence|Medical Imaging
Interventions: OTHER: Artificial Intelligence-based medical imaging interpretation
Sponsor: Huashan Hospital
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 2000
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2022-04-01
Completion Date: 2026-12-01
Locations: Huashan Hospital, Shanghai, 200040, China

Summary:
The early identification and severe warning of acute respiratory infectious diseases are of paramount importance. Utilizing effective means to make correct diagnoses of the source of infection at an early stage is the premise of all effective measures. AI-MID is a research initiative that uses artificial intelligence tools to assist in the clinical medical imaging diagnosis of respiratory diseases, aiming to reduce the time doctors spend reviewing images, increase work efficiency, and enhance the sensitivity and specificity of pneumonia detection, thereby improving the detection rate of pneumonia at the grassroots level. This approach facilitates precise prevention, accurate diagnosis, and precise treatment.

Primary Outcome Measures: Evaluating the Diagnostic Efficacy of Artificial Intelligence Diagnostic Tools in Medical Imaging of Respiratory Infectious Diseases, To evaluate the diagnostic efficacy of computer-aided detection (CAD) software in the identification of pulmonary infections, the study will employ the following methods:

Imaging Criteria: Experienced radiologists will interpret the medical imaging of study participants, serving as the imaging standard.

Computer-Aided Detection: Concurrently, the CAD software will analyze the participants' medical imaging to generate diagnostic results.

Efficacy Assessment: The accuracy and consistency of the CAD software will be evaluated by comparing its interpretations with the diagnoses made by the radiologists., 2 years
Secondary Outcome Measures: Utilizing artificial intelligence tools for early identification and severe warning of respiratory infectious diseases, By integrating the medical imaging of study participants with the corresponding respiratory pathogen detection results, these data will be used as the training set input into the AI diagnostic tool, enabling it to undergo deep learning. This process will establish an AI diagnostic tool based on pathogen imaging. After completing the data collection for both retrospective and prospective study sections, we plan to evaluate the disease progression and prognosis of the study participants based on survival analysis and predictive modeling. By integrating clinical data and imaging data, we aim to enhance the accuracy and precision of the prognostic assessment model. The model will be continuously optimized according to the changes in the conditions of study participants enrolled over different time periods., 2 years
Study of Therapeutic Efficacy of CAR-T Cell Therapy in Patients With MDR-SRNS
NCT Number: NCT06553898
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Multi-Drug Resistant Nephrotic Syndrome|CAR-T Cell Therapy
Interventions: BIOLOGICAL: anti-BCMA/CD70 CAR-T cells
Sponsor: The Children's Hospital of Zhejiang University School of Medicine
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 18
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-13
Completion Date: 2027-07-31
Locations: Children's Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, China

Summary:
This is an investigator-initiated trial aimed at assessing the safety and efficacy of anti-BCMA/CD70 CAR-T cells in the treatment of patients with Multi-drug resistant SRNS

Primary Outcome Measures: The safety of CAR-T cell therapy in patients with MDR SRNS, Incidence and severity of Adverse Events (AEs) and Serious Adverse Event（SAEs）,including changes in laboratory values,Electrocardiograph(ECG) and vital signs assessed by CommonTerminology Criteria for Adverse Events (CTCAE) v5.0., 3 months
Secondary Outcome Measures: The efficiency of CAR-T cell therapy in patients with MDR SRNS, Complete response and partial response rate (complete response defined as Urinary protein/creatinine ratio (uPCR) ≤200 mg/g for 3 consecutive days, partial response is defined as a 50% or more reduction in proteinuria from baseline and 200mg/g \< uPCR \<2000mg/g), 6 months|Cellular kinetics, The Peak Plasma concentration (Cmax) of amplified BCMA/CD70 CAR-T cells in peripheral blood after reinfusion, the time to reach the maximum concentration (Tmax) and area under the plasma concentration versus time curve at 28 days /90 days after reinfusion (AUC28d/90d)., 3 months
Ph II Study of Enfortumab Vedotin in Patients With Advanced or Metastatic CRC or HCC
NCT Number: NCT06553885
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Metastatic Colorectal Cancer|Hepatocellular Carcinoma
Interventions: DRUG: Enfortumab Vedotin
Sponsor: H. Lee Moffitt Cancer Center and Research Institute
Collaborators: Astellas Pharma Inc
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2029-09
Locations: Moffitt Cancer Center, Tampa, Florida, 33612, United States

Summary:
This study is a multi-indication, open-label, single-treatment arm, parallel-cohort phase II study of enfortumab vedotin in adult participants with advanced or metastatic colorectal cancer (CRC) or hepatocellular carcinoma (HCC) who have been previously treated with one or more lines of systemic therapy.

Primary Outcome Measures: Overall response rate (ORR), The ORR is defined as the proportion of evaluable patients with confirmed CR or PR according to RECIST v1.1., Up to 3 years
Secondary Outcome Measures: Duration of Response (DOR), The DOR is defined as the time from first documentation of objective response (CR or PR that is subsequently confirmed) to the first documentation of PD (per RECIST v1.1) or to death due to any cause, whichever comes first., Up to 3 years|Progression-free Survival (PFS), PFS is defined as the time from start of study treatment to first documentation of objective tumor progression (PD per RECIST v1.1), or to death due to any cause, whichever comes first., Up to 3 years|Overall Survival (OS), OS is defined as the time from start of study treatment to date of death due to any cause., Up to 3 years
Phase 2 Open Label Randomized Study of Pirtobrutinib and Brexucabtagene Autoleucel in R/R MCL
NCT Number: NCT06553872
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Mantle Cell Lymphoma
Interventions: DRUG: Pirtobrutinib|DRUG: Brexucabtagene Autoleucel
Sponsor: H. Lee Moffitt Cancer Center and Research Institute
Collaborators: Bankhead-Coley Florida Biomedical Research Program|Eli Lilly and Company
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-23
Completion Date: 2029-08
Locations: Stanford Cancer Center, Stanford, California, 94305, United States|Univ of Miami - Sylvester Comprehensive Cancer Center, Miami, Florida, 33136, United States|Moffitt Cancer Center, Tampa, Florida, 33612, United States

Summary:
This is a phase 2, open-label, randomized, multicenter clinical trial in patients with relapsed/refractory mantle cell lymphoma (R/R MCL) who meet the criteria for standard-of-care FDA label for CD19 CAR T-cell therapy with brexucabtagene autoleucel (brexu-cel).

Primary Outcome Measures: Progression-free survival (PFS) - Historical comparison, The one-sample log-rank test will be used to determine if there's a statistically significant difference in PFS in patients treated on this trial of pirto plus brexucel compared to a historical control., 12 months|Progression-free survival (PFS) - Comparison between arm A and arm B, The one-sample log-rank test will be used to determine if there's a statistically significant difference in PFS in patients treated with concurrent pirtobrutinib ("con-pirto") versus patients treated with no concurrent pirtobrutinib ("con-none")., 12 months
Secondary Outcome Measures: Severe ICANS, Number of participants experiencing severe ICANS (grade 3 or higher by ASTCT criteria) in the first 60 days after CAR T infusion., Up to 60 days post CAR T|Severe CRS, Number of participants experiencing severe CRS (grade 3 or higher by ASTCT criteria) in the first 60 days after CAR T infusion., Up to 60 days post CAR T|Overall Response Rate (ORR), Best Overall Response Rate (ORR) by Lugano Criteria in the full cohort compared to the historical control, and comparing between Arm A and Arm B., Up to 48 months|Overall survival (OS), Overall survival (OS) of patients treated with pirtobrutinib with brexu-cel in the full cohort compared to the historical control, and comparing between Arm A and Arm B., Up to 48 months
Evaluation of ADM(SC Derm® Recon) in Breast Reconstruction
NCT Number: NCT06553859
Acronym: SCderm
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Breast Cancer Female
Interventions: OTHER: No intervention conducts.
Sponsor: DOF Inc.
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-06-12
Completion Date: 2025-06
Locations: Asan Medical Center, Seoul, 05505, Korea, Republic of

Summary:
The goal of this observational study is to examine any clinical differences in the outcomes of breast reconstruction surgeries using Acellular Dermal Matrix (ADM) processed by CO2 supercritical fluid technology compared to other ADM products that have been washed with detergents. The study will also assess safety outcomes.

Primary Outcome Measures: The number of occurrences of pre-determined expected adverse events and complications, The number of occurrences of pre-determined expected adverse reactions and complications will be compared between the experimental group and the control group., From the day of operation of breast reconstruction to 12 months
Secondary Outcome Measures: Subjects' self-assessment of satisfaction with physical and psychological well-being using the BREAST-Q survey, Subjects will complete the BREAST-Q survey before and after breast reconstruction surgery, which includes multiple questions on a scale from 1 to 5, where a higher score represents greater satisfaction. For instance, there is a question from the satisfaction with breasts part "In the past week, how satisfied or dissatisfied were you with how you look in the mirror with clothes on?" The answer would be selected the scale from 1 (Very Dissatisfied) to 4 (Very Satisfied). The evaluation will be implemented by comparison of average scores for each question between the experimental group and the control group., From the day of operation of breast reconstruction to 12 months
A Clinial Trial of Lutetium [177Lu]-FAP-75 for the Treatment of Patients With Advanced Solid Tumors
NCT Number: NCT06553846
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Solid Tumors
Interventions: DRUG: Lutetium [177Lu]-FAP-75
Sponsor: Fudan University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-19
Completion Date: 2025-08-18
Locations: Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center;Pancreatic Cancer Institute, Fudan University, Shanghai, Shanghai, 200032, China

Summary:
To explore the safety, tolerability, initial efficacy, pharmacokinetic profile and radiation dosimetry of lutetium \[177Lu\]-FAP-75 in the treatment of patients with advanced solid tumors.

Primary Outcome Measures: Overall Response Rate(ORR), Evaluated by RECIST1.1, Up to approximately 12 months|Adverse events(AEs), AEs , are assessed by NCI-CTCAE v5.0, From the first drug administration to within 90 days for the last drugs dose|Dose Limiting Toxicity(DLT), Dose Limiting Toxicity are assessed by NCI-CTCAE v5.0, within 6 weeks from the first drug administration|Second-stage dose, Second-stage dose is the recommend dose for the second stage of this trial which is determined by the safety profile of the first stage of this trial., through study completion, an average of 1 year
Secondary Outcome Measures: Overall survival(OS), Time from the date of enrollment to date of death from any cause., Up to approximately 12 months|Disease Control Rate(DCR), Evaluated by RECIST1.1, Up to approximately 12 months|Duration of Response(DoR), Evaluated by RECIST1.1, Up to approximately 12 months|Progression free survival (PFS), PFS is defined as the time from the date of first dose of study drug to the date of the first documentation of disease progression or date of death, whichever occurs first., From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months|Radiation dosimetry, Dosimetry, measured as absorbed dose in tumor and normal organs (Gy/GBq), was estimated in the first treatment cycle for each patient., Up to 6 weeks
The Effect of MediYoga on Sleep Quality, Blood Pressure, and Quality of Life in Older Adults With Hypertension:
NCT Number: NCT06553820
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Hypertension|Quality of Life|Quality of Sleep|Mental Health
Interventions: BEHAVIORAL: Intervention group I, Yoga 20 minuts x2 pr week|BEHAVIORAL: Intervention Group II, Yoga 40 minuts x2 pr week|OTHER: Control Group, No intervention
Sponsor: Herlev and Gentofte Hospital
Sex: ALL
Age: OLDER_ADULT
Enrollment: 180
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2026-07

Summary:
The goal of this Randomized Controlled Trial is to test if an intervention consisting of Yoga can increase quality of sleep and health related quality of life and decrease BP. Secondary to explore and describe the implementation of a yoga intervention and the participants' experiences and perspectives on the intervention in a process evaluation.

The main question it aims to contribute knowledge about intervention of Yoga in a home environment for individuals with hypertension aged 65 years or older. Participants will (if they got selected into one of the two interventions groups), participate in Yoga exercises delivered by an app for 2 times a week for 10 weeks. Researchers will compare the intervention groups with the control group to see if Medi yoga has an effect in older people with hypertension.

Primary Outcome Measures: sleep quality, Patient reported sleep quality measured on the PSQI (Pittsburg Sleep Quality Index). Minimum value: 0 Maximum value: 21 Higher scores: Indicate worse sleep quality The PSQI assesses sleep quality by compiling responses to questions covering various aspects of sleep, such as sleep duration, sleep problems, and daytime fatigue.

A total score of 5 or higher generally indicates poor sleep quality.

Between group change in baseline versus follow-up patient-reported sleep quality as assessed by the psqi questionnaire ., 10 weeks
Secondary Outcome Measures: Blood pressure, Reducing BP measured by self-monitoring in own home. Both Systolic blood pressure and diastolic blood pressure will be measured., 10 weeks|Health-related quality of life, improving health-related quality of life measured by SF-12 questionnaire. Minimum Value: 0 Maximum Value: 100 Higher Scores Mean: Better health-related quality of life, 10 weeks|Mental health, with improving anxiety and depression, measured by the Hospital Anxiety and Depression Scale (HADS) Minimum Value: 0 Maximum Value: 21 (for each subscale: anxiety and depression; the total score can range from 0 to 42) Higher Scores Mean: Worse anxiety or depression. HADS assesses levels of anxiety and depression through separate subscales for each condition., 10 weeks
A Single-arm, Multicenter Clinical Study of Fruquintinib Combined With Cadonilimab Injection and Temozolomide in Second-line and Subsequent Treatment of Advanced Melanoma
NCT Number: NCT06553781
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Malignant Melanoma
Interventions: DRUG: Temozolomide、Fruquintinib、Cadonilimab
Sponsor: Fudan University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 28
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2027-09-01

Summary:
This single-arm, multicenter clinical study enrolled patients with advanced malignant melanoma who had failed previous first-line therapy (cutaneous melanoma patients were excluded), and patients with BRAF V600 mutations required targeted therapy.

Primary Outcome Measures: ORR（objective response rate）, Defined as percentage of participants achieving assessed complete response (CR) and partial response (PR) by the investigator according to the RECIST 1.1., 5 months
Secondary Outcome Measures: OS Overall survival, From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, two years|DCR Disease control rate, From date of randomization until the end of treatment or the date of first documented progression or date of death from any cause, whichever came first,, two years|PFS Progression-free survival, PFS were defined as from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, 5 months|Safety, Adverse events as assessed by NCI CTCAE v5.0overall incidence of adverse events (AE); incidence of grade 3 or higher AE; incidence of severe adverse events (SAE); incidence of AEs leading to discontinuation of drug use; incidence of AEs leading to suspension of drug use, two years
Evaluation of Maralixibat in Pruritus Associated With General Cholestatic Liver Disease (EXPAND)
NCT Number: NCT06553768
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Cholestatic Liver Disease (Except ALGS, PFIC, PBC and PSC)
Interventions: DRUG: Maralixibat|OTHER: Placebo
Sponsor: Mirum Pharmaceuticals, Inc.
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 90
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-10
Completion Date: 2027-02
Locations: Children's Hospital Los Angeles (CHLA), Los Angeles, California, 90027, United States|Stanford Children's Health in Palo Alto, Palo Alto, California, 94304, United States|Lurie Children's Hospital, Chicago, Illinois, 60611, United States|Ochsner Clinic Foundation, New Orleans, Louisiana, 70121, United States|New York University (NYU), New York, New York, 10016, United States|Baylor College of Medicine, Houston, Texas, 77030, United States|University of Utah, Salt Lake City, Utah, 84112, United States|Hospital de Criança de Brasília (HCB), Brasília, Brazil|Hospital da Criança Santo Antonio, Porto Alegre, Brazil|Hospital Sírio-Libanês, São Paulo, Brazil|Hôpital Femme Mère Enfant, Bron, France|Hôpital Kremlin Bicêtre, Paris, France|Azienda Ospedaliera Papa Giovanni XXIII, Bergamo, 24127, Italy|Ospedale Pediatrico Bambino Gesu, Rom, Italy|Hotel Dieu de France, Beirut, Lebanon|Hospital Infantil de México Federico Gómez, Mexico City, Mexico|Consultario de Joshue David Covarrubias Esquer, Zapopan, Mexico|Instytut Pomnik Centrum Zdrowia Dziecka, Warsaw, Poland|Hospital Sant Joan de Deu, Barcelona, Spain|Hospital Universitario Vall d'Hebron, Barcelona, Spain|Hospital Universitario La Paz, Madrid, Spain|King's College Hospital NHS Foundation Trust, London, United Kingdom

Summary:
The purpose of this study is to determine whether the investigational treatment (maralixibat) is safe and effective in pediatric and adult participants who have cholestatic liver disease with pruritus that has been refractory to other therapies, and who have no other treatment options.

Primary Outcome Measures: Mean change in the ItchRO(Obs) severity score, ItchRO(Obs) severity score = Itch Reported Outcome Observer assessment severity score; scale between 0 (not itchy at all) and 4 (extremely itchy); the lower the score the better., From baseline to average of week 13 to week 20
Secondary Outcome Measures: Mean change in total sBA (serum bile acid) level, From baseline to average of week 12 and week 20
High Definition Profiling of Ovarian Cancer Ascites
NCT Number: NCT06553742
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Ovarian Cancer|High Grade Ovarian Serous Adenocarcinoma|Ascites
Sponsor: European Institute of Oncology
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09
Completion Date: 2033-12
Locations: European Institute of Oncology, Milan, Italy

Summary:
This project entails the collection of a prospective cohort of ascites (AS) samples from High Grade Serous Ovarian Cancer (HGSOC) patients.

High Grade Serous Ovarian Cancer (HGSOC) is a major cause of cancer-related mortality, due to the late-stage diagnosis and failure of surgery and chemotherapy (CHT) to eradicate the disease with no significant improvement in overall survival.

The primary objective of the project is to generate a comprehensive map of ascites cell components, detailing both their intrinsic features and the landscape of cellular interactions mediated by soluble factors in ascitic fluid.

Primary Outcome Measures: Generation of a comprehensive map of ascites cell components, The samples will be stratified according to a DNA-methylation based signature specific for the tissue of origin of HGSOC.

The cellular fraction derived from ascites samples will be profiled by single cell multiomics to define the cell populations associated to either the fallopian tube or ovarian surface epithelium origin. In parallel, ascitic fluid will be profiled by ELISA to define the soluble components present in the two HGSOC subtypes. These data will be used to generate a map of ascites cell components and biomarkers specific for the two tissues of origin of this disease. This map will be exploited to highlight possible therapeutic avenues for HGSOC patients., 48 month
Effects of Vitamin D and Prebiotic Supplementation on Glucose Control During Pregnancy
NCT Number: NCT06553729
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Glucose Intolerance During Pregnancy
Interventions: DRUG: Vitamin D3|DIETARY_SUPPLEMENT: Prebiotics|DIETARY_SUPPLEMENT: Prebiotics placebo|DIETARY_SUPPLEMENT: Vitamin D3 placebo
Sponsor: Huazhong University of Science and Technology
Sex: FEMALE
Age: ADULT
Enrollment: 500
Study Design: Allocation: RANDOMIZED|Intervention Model: FACTORIAL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-08-20
Completion Date: 2026-12-31
Locations: Central People's Hospital of Zhanjiang, Zhanjiang, Guangdong, China|Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China

Summary:
The goal of this randomized, double-blind, placebo-controlled study included pregnant women at high risk of GDM at 6-15 weeks of gestation is to investigate whether supplementation with vitamin D (1600 IU per day) or prebiotics (inulin, 10 gram per day) during pregnancy has beneficial effects on controlling blood glucose during pregnancy.

Primary Outcome Measures: Concentration of fasting blood glucose, Concentration of fasting blood glucose, measured in mmol/L, 24-28 gestational weeks, 32-36 gestational weeks, and delivery|Glycated hemoglobin (HbA1c), Concentration of HbA1c, measured in the percentage of hemoglobin, 24-28 gestational weeks, 32-36 gestational weeks, and delivery
Secondary Outcome Measures: Incidence of Gestational Diabetes, 75g oral glucose tolerance test (OGTT) will be performed at 24-28 weeks of gestation to diagnose gestational diabetes, 24-28 gestational weeks|Concentration of blood lipids, Concentration of blood lipids (total cholesterol, triglycerides, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol), measured in mmol/L, 24-28 gestational weeks, 32-36 gestational weeks, and delivery|Concentration of plasma 25(OH)D, Concentration of plasma 25(OH)D concentrations, measured in nmol/L, 24-28 gestational weeks, 32-36 gestational weeks, and delivery|Concentration of C-reactive protein (CRP), Concentration of CRP, measured in mg/dL, 24-28 gestational weeks, 32-36 gestational weeks, and delivery|Concentration of interleukin-6 (IL-6), Concentration of IL-6, measured in pg/mL, 24-28 gestational weeks, 32-36 gestational weeks, and delivery|Metagenomic analysis of the gut microbiota, The diversity of the gut microbiota will be assessed by high-quality whole-metagenomic sequencing, 24-28 gestational weeks, 32-36 gestational weeks, and delivery|Birth weight, The baby's weight at birth, Weight in grams, Delivery|Gestational duration, The length of a woman's pregnancy from the start of her last period, duration in days, Delivery|Delivery mode, Method of the baby being born during childbirth, vaginal delivery or cesarean section, Delivery
Ultrasound-Guided Hydrodilatation With Triamcinolone Acetonide for Adhesive Capsulitis
NCT Number: NCT06553716
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Postoperation Pain
Interventions: PROCEDURE: Ultrasound-Guided Hydrodilatation
Sponsor: General Hospital of Ningxia Medical University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 70
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-02-05
Completion Date: 2024-11-30
Locations: General hospital of Ningxia medical university, Yinchuan, Ningxia, 750004, China

Summary:
The purpose of this study was to compare the efficacy of ultrasus-guided hydrodilation of Rotator Cuff Interval combined with Posterior Glenohumeral recess approach and hydrodilation of the Rotator cuff Interval alone in Adhesive Capsulitis.

Primary Outcome Measures: Shoulder Pain and Disability Index, The SPADI was used to assess the severity ofpain and disability. A previous study has shown that the Chinese version of the SPADI has high internal consistency and test-retest reliability (Yao et al., 2017). It consists of 13 items that are divided into 2 subscales: pain scale (5 items) and disability scale (8 items) (Roach et al., 1991). Each item is rated from 0 (no pain/no difficulty) to 10 (worst pain experienced/ very difficult). The score is then transformed to a 100-point scale, with the highest score indicating the most severe pain and disability. In the literature, the minimal and clinically relevant difference for SPADI has been reported to be 10 points, At baseline, one week, three weeks, six weeks, 12 weeks after treatment.
Secondary Outcome Measures: visual analogue scale, Regarding VAS, patients were asked to indicate the intensity of their average level ofpain in the affected shoulder within the past 1 week using an 11-point scale, ranging from 0 (no pain) to 10 (worst pain imaginable)., At baseline, one week, three weeks, six weeks, 12 weeks after treatment.|Active shoulder range of motion, In terms of ROM, the degrees of shoulder flexion, abduction, external and internal rotation were measured by a goniometer in the supine position in a random sequence, Baseline data, six weeks,12 weeks after treatment|adverse reaction, Pain after hydrodilation , reduced sensation and motor control of the affected arm, skin flushing, nausea, dizziness, and fainting, one week after treatment
Acceptance and Commitment Therapy Based Group Psychoeducation for Nursing Students
NCT Number: NCT06553703
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Psychological Flexibility|Somatic Symptom
Interventions: OTHER: Acceptance and commitment therapy based group psychoeducation
Sponsor: Çankırı Karatekin University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 54
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-04-18
Completion Date: 2024-09-13
Locations: Tuğba Yildirim, Merkez, Çankırı, 18200, Turkey

Summary:
In this study, the effects of acceptance and commitment therapy-based group psychoeducation applied to nursing students on psychological flexibility and somatic symptoms will be examined. The research will be carried out as a randomized controlled experimental study with a pre-test-post-test and follow-up design.

Primary Outcome Measures: Change in the Psychological Flexibility Scale, The Psychological Flexibility Scale consists of 28 items and five sub-dimensions. The sub-dimensions of the scale are: "Values and committed action", "Contact with the present moment", "Acceptance", "Self as Context" and "Defusion." The increase in the scores obtained from the sub-dimensions and total scores of the scale means that individuals are psychologically flexible. The lowest score that can be obtained from the scale is 28, and the highest is 196., Baseline, 8th week, 1st month follow-up, 3rd month follow-up) (Pretest-posttest follow-up experimental design
Secondary Outcome Measures: Bradford Somatic Symptom Inventory Change, Bradford Somatic Inventory consists of 44 items. It questions the individual's experience of a wide variety of somatic symptoms on less than 15 days or more than 15 days during the previous month. In the total score of the scale, 0-25 is the low range, 26-40 is the medium range, and\>40 is the high range., screening, baseline, 8th week, 1st month follow-up, 3rd month follow-up) (Pretest-posttest follow-up experimental design)
Other Outcome Measures: Inclusion Form, The inclusion form is a seven-question form prepared by the researcher to determine the disease status of nursing students (physical and psychiatric disease diagnosis, treatment, psychotherapy, or psychological counseling status) and sociodemographic characteristics (nationality and pregnancy status)., screening|Participant Information Form, The participant information form is a ten-question form prepared by the researcher to determine the sociodemographic characteristics of nursing students (age, gender, class information, marital status, mother's education status, father's education status, family income status, family type, where they lived before starting university and who they currently live with)., baseline, 8th week, 1st month follow-up, 3rd month follow-up) (Pretest-posttest follow-up experimental design)
Brain Gym Therapy on Quality of Sleep Among Elderly People
NCT Number: NCT06553690
Acronym: BG/E
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Sleep Disorder|Insomnia|Cognitive Function Abnormal|Old Age; Debility|Brain Gym Therapy
Interventions: OTHER: Brain Gym Therapy
Sponsor: Cairo University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 120
Study Design: Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-08-15
Completion Date: 2024-10-12

Summary:
This clinical trial aims to evaluate the impact of Brain Gym Therapy on the quality of sleep among elderly individuals attending healthcare facilities. The study will explore whether this non-pharmacological intervention can improve sleep quality, which is often compromised in the elderly population due to various health conditions and age-related changes. Participants will undergo Brain Gym Therapy sessions over a specified period, and their sleep quality will be assessed using validated sleep measurement tools. The findings may provide insights into alternative methods for enhancing sleep in older adults.

Primary Outcome Measures: Improvement in Sleep Quality, The primary outcome measure will assess the improvement in sleep quality among elderly participants who undergo Brain Gym Therapy compared to those receiving standard care. Sleep quality will be evaluated using the Pittsburgh Sleep Quality Index (PSQI), a validated and widely used instrument that measures various aspects of sleep including duration, latency, efficiency, disturbances, and subjective sleep quality. The PSQI score ranges from 0 to 21, with higher scores indicating poorer sleep quality., Baseline, Week 4 (post-intervention), and Week 8 (follow-up)