pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Analysis of Lung Cancer Tissue With Spatial Frequency Domain Imaging
NCT Number: NCT06549088
Acronym: ALCATS
Status: ENROLLING_BY_INVITATION
Study Type: OBSERVATIONAL
Conditions: Lung Diseases|Cancer, Lung
Interventions: DEVICE: Spatial Frequency Domain Imaging
Sponsor: University of California, Irvine
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-08-07
Completion Date: 2026-12-31
Locations: University of California, Irvine Medical Center, Orange, California, 92868, United States

Summary:
This study investigates if a new imaging device can detect different types of lung tissue using spatial frequency domain imaging (SFDI). Specifically, this study aims to detect lung nodules within normal lung tissue and determine if lung nodules are cancerous. Patients who have confirmed or suspected lung nodules and who are undergoing resection of those nodules will be recruited for the study. Study participants will undergo standard of care lung nodule resection in the operating room, and the resected specimen will be imaged using the SFDI device immediately after removal from the surgical field. The data captured from the SFDI images will then be compared to the pathology findings to identify optical properties of normal and cancerous lung tissue. Because the intervention is conducted on resected biospecimens, this study yields minimal risk to participants.

Primary Outcome Measures: Markers of native lung parenchyma, Use SFDI to identify markers of lung nodule vs native lung parenchyma, May 7, 2023 to December 31, 2026
Secondary Outcome Measures: Cancer identification, Distinguish cancer vs non-cancer in lung nodules with SFDI, May 7, 2023 to December 31, 2026
Therapeutic Support to Strengthen Dignity, Mental Well-being and Quality of Life in Acute Palliative Care Patients.
NCT Number: NCT06549075
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Promoting Dignity, Meaningfulness and Mindfulness in Acute Palliative Care
Interventions: OTHER: Therapeutic support|OTHER: Standard Specialized Palliative Consultation Service
Sponsor: University Hospital, Basel, Switzerland
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-09-10
Completion Date: 2025-04-30

Summary:
The goal of this clinical trial is to test the benefit of a newly designed personalized therapeutic intervention compared to the standard specialized palliative care service at the swiss acute palliative hospital care.The main questions it aims to answer are:

Does an additional therapeutic support that fits the individual needs of a palliative care patient increases dignity and mental well-being as measures by a questionnaire (Patient Dignity Inventory) to a larger extent than standard palliative care alone? Is the additional therapeutic support perceived as helpful? Researchers will compare the additional therapeutic support with standard palliative care to standard palliative care alone.

Participants will:

Receive additional therapeutic support in two structured sessions a 60 minutes and/or standard palliative care Fill out questionnaires before and after therapeutic interventions and standard palliative care Provide a semi-structured interview following the therapeutic support

Primary Outcome Measures: Patient Dignity Inventory, Questionnaire (Self-reported outcome), Baseline, after intervention, 4 week follow-up
A Transdiagnostic Sleep Health Intervention for Veterans With PTSD
NCT Number: NCT06549049
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Stress Disorders, Post-Traumatic|Sleep Initiation and Maintenance Disorders
Interventions: BEHAVIORAL: TranS-C for PTSD|BEHAVIORAL: Sleep Psychoeducation Control
Sponsor: VA Office of Research and Development
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 182
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-11-01
Completion Date: 2028-10-31
Locations: San Francisco VA Medical Center, San Francisco, CA, San Francisco, California, 94121-1563, United States

Summary:
Sleep disturbance is a major problem in Veterans with posttraumatic stress disorder (PTSD). This study will test a version of a sleep treatment that's been shown to be effective in the general population, with some changes to tailor it to the needs of Veterans with PTSD and sleep disturbance.

Primary Outcome Measures: World Health Organization Disability Assessment Schedule (WHODAS), The WHODAS is a validated, comprehensive measure of health-related disability., Week 0, Week 5, Post-Treatment, 3-Month Follow-Up, 6-Month Follow-Up
Secondary Outcome Measures: Insomnia Severity Index (ISI), The ISI will be used to measure change in severity of insomnia symptoms., Week 0, Week 5, Post-Treatment, 3-Month Follow-Up, 6-Month Follow-Up|Clinician-Administered PTSD Scale for DSM-4 Distressing Dream Score (CAPS-4 Nightmare Item), The CAPS-IV Nightmare Item will be used to measure change in nightmare symptoms., Week 0, Week 5, Post-Treatment, 3-Month Follow-Up, 6-Month Follow-Up|Clinician-Administered PTSD Scale for DSM-5 (CAPS-5), The CAPS-5 will be used to measure change in overall PTSD symptoms., Week 0, Post-Treatment, 3-Month Follow-Up, 6-Month Follow-Up
Perimetric Testing With Virtual Reality
NCT Number: NCT06549010
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Glaucoma
Interventions: DIAGNOSTIC_TEST: Perimetric test
Sponsor: Envision Health Technologies, Inc.
Collaborators: Illinois College of Optometry
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: FACTORIAL|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-07-03
Completion Date: 2024-10
Locations: Illinois College of Optometry / Illinois Eye Institute, Chicago, Illinois, 60616, United States

Summary:
Perimetry is an essential component in the diagnosis and monitoring of glaucoma. Since the advent of Standard Automated Perimetry (SAP), one of the clinical standards has been the Humphrey Field Analyzer (HFA, Carl Zeiss AG, Oberkochen, Germany). Visual field (VF) testing provided by the HFA is standard-of-care in glaucoma clinics and other ophthalmology and optometry practices. However, the HFA is a large device that does not allow for examination outside the clinic and can be uncomfortable for patients with limited mobility.

This study aims to evaluate a novel head-mounted perimeter against the HFA as an alternative method of VF testing. This new perimeter uses a Virtual Reality (VR) headset and a gamified version of VF testing to assess the visual function of healthy eyes and patients. The results of this study will potentially serve as pilot data for the design of a larger study that involves the full assessment of the VR headset and its VF test, based on various testing strategies.

Primary Outcome Measures: Visual field perimetry light sensitivity, Localized differential light sensitivity threshold measured in decibels (dB), 1 day|Visual field perimetry foveal sensitivity, Foveal threshold in decibels (dB), 1 day|Visual field perimetry test duration, Test duration measured in minutes, 1 day
Secondary Outcome Measures: Optical Coherence Tomography (OCT), Optical Coherence Tomography (OCT) thickness values may be used, such as Retinal nerve fiber layer (RNFL) and ganglion cell complex (GCC) thickness, measured in microns., 1 day
A Phase I Study of GZR18 Injection in Healthy Subjects
NCT Number: NCT06548997
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Type 2 Diabetes|Overweight and Obesity
Interventions: DRUG: GZR18|OTHER: Placebo
Sponsor: Gan and Lee Pharmaceuticals, USA
Sex: ALL
Age: ADULT
Enrollment: 57
Study Design: Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2021-12-02
Completion Date: 2022-10-20
Locations: Gan & Lee Pharmaceuticals Co., Ltd, Beijing, China

Summary:
This trial is conducted in China. The aim of the trial is to evaluate the safety and tolerability of GZR18 injection in healthy subjects following single dose and once-weekly dose for 2 consecutive weeks until reaching the target dose.

Primary Outcome Measures: TEAE, Incidence of treatment-emergent adverse events (TEAE), after 28/35 days of treatment
Secondary Outcome Measures: Cmax, The peak concentration after reaching the target dose, 28/35 days|AUClast, the area under the concentration-time curve from 0 to the last time that the concentration can be accurately measured, 28/35 days|AUC0-inf, the area under the concentration-time curve from 0 to infinity, 28/35 days|Tmax, the peak time, 28/35 days|λz, the elimination rate constant, 28/35 days|t1/2, the half-life, 28/35 days|tlag, retention time, 28/35 days|CL/F, apparent clearance rate, 28/35 days|Vz/F, apparent volume of distribution, 28/35 days|AUC%extra, extrapolation percentage of AUC0-in, 28/35 days|MRT, average retention time, 28/35 days|AUCglucose0-14h, area under the concentration-time curve of fasting blood glucose from 0 to 14 hours after each administration, 28/35 days|AUCc-peptide0-14h, area under the concentration-time curve of fasting C-peptide from 0 to 14 hours after each administration, 28/35 days|AUCinsulin0-14h, area under the concentration-time curve of fasting insulin from 0 to 14 hours after each administration, 28/35 days|body weight, 28/35 days|body mass index (BMI）, 28/35 days
Respiratory Sarcopenia in Older Adults
NCT Number: NCT06548984
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Sarcopenia
Interventions: OTHER: diaphragmatic exercises|OTHER: Respiratory muscle training
Sponsor: Felipe León Morillas
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2025-12-31
Locations: Hospital Clinic Virgen de la Arrixaca Ctra. Madrid-Cartagena, s/n, 30120 El Palmar, Murcia, Murcia, 30120, Spain

Summary:
The objectives of this study are to describe the prevalence of respiratory sarcopenia, evaluate its pattern of evolution over a one-year follow-up, and determine the response to a therapeutic exercise program in older adults in a geriatric nursing clinic.

A sample of approximately 115 older adults, of both sexes, from the geriatric nursing clinic of the Virgen de la Arrixaca Hospital, Murcia, will participate in the study. In the first stage, a prospective observational study will be carried out, with one year of follow-up, and subsequently a randomized controlled clinical trial, with patients who have been diagnosed with respiratory sarcopenia. In the clinical trial, patients will be divided into 3 groups: control, experimental 1 (diaphragmatic exercises) and experimental 2 (respiratory muscle training). Sociodemographic and clinical variables, physical function (palm grip, 5STS, 4MGS), respiratory function (respiratory muscle strength and diaphragmatic thickness) and health outcomes (respiratory infections, visit to the emergency department, hospitalization, falls, bedridden and/or death). Descriptive statistics, univariate and multivariate logistic regression models, Cox proportional hazards model and Kaplan-Meier curves will be used to analyze the data from the longitudinal study. To compare the differences between pre- and post-intervention of the clinical trial, a two-factor analysis of variance for repeated measures will be used. A P-value \<0.05 will be considered significant in all analyses. The recording and analysis of the data will be carried out with the IBM SPSS Statistics 24® program.

Primary Outcome Measures: RESPIRATORY MUSCLE FUNCTION, INSPIRATORY AND EXPIRATORY PRESSURE OF THE MUSCULATURE, 24 Months|ultrasound, diaphragm muscle thickness, 24 Months|physical function hand grip, Hand grip: palm press strength, 24 Months|Physical function, five times sit-up test (5STS), 24 Months|Physical function walking speed, walking speed (4MGS), 24 Months|body composition, Calculation of bioimpedance, 24 Months
Secondary Outcome Measures: Sociodemografic, sex, age, marital status and educational level, 24 months
A Phase I Study of GZR18 Injection in Obese/Overweight Subjects
NCT Number: NCT06548945
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Overweight and Obesity
Interventions: DRUG: GZR18|OTHER: Placebo
Sponsor: Gan and Lee Pharmaceuticals, USA
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 16
Study Design: Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2023-04-25
Completion Date: 2023-08-14
Locations: Gan & Lee Pharmaceuticals Co., Ltd, Beijing, China

Summary:
This is a randomized, double-blind, placebo-controlled, dose-escalation phase I clinical study. A sequential design is used in this trial with a single dose escalation climb test, to investigate the safety, tolerability, and PK/PD characteristics of GZR18 injection in Chinese obese/overweight subjects.

Primary Outcome Measures: TEAE, Incidence of Treatment Emergent Adverse Event(s), 50 days|Anti-Drug Antibody (ADA) and Neutralizing Antibody (Nab), 50 days
Secondary Outcome Measures: Cmax, Maximum plasma drug concentration, 50 days|AUClast, area under the curve from 0 through the time of the last accurately measurable concentration, 50 days|AUC0-inf, area under the curve extrapolated to infinity, 50 days|Tmax, time to maximum plasma drug concentration, 50 days|λz, elimination rate constant, 50 days|t1/2, half-life, 50 days|tlag, lag time, 50 days|CL/F, apparent clearance, 50 days|Vz/F, volume of distribution/F, 50 days|AUC%extra, percent of AUC0-inf extrapolated, 50 days|MRT, mean residence time, 50 days|Weight, 50 days|Body Mass Index (BMI), 50 days
A Study to Evaluate the Safety, Tolerance, PK and PD Parameters of GZR33 and GZR101 in Healthy Male Adult Subjects
NCT Number: NCT06548932
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Healthy Subjects
Interventions: DRUG: GZR33 Injection|DRUG: GZR101 Injection|DRUG: Placebo
Sponsor: Gan and Lee Pharmaceuticals, USA
Sex: MALE
Age: ADULT
Enrollment: 52
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2022-06-30
Completion Date: 2023-02-24
Locations: Study Site 01, Tianjin, China

Summary:
This is a randomized, double-blind, placebo-controlled, single dose phase I clinical study. It is divided into two parts: part A , a single ascending dose assessment of GZR33, and partB, a single dose evaluation of GZR101.

Primary Outcome Measures: Incidence of adverse events (AE), Any changes or abnormal results in the following safety variables: incidence of adverse events (AE), including but not limited to hypoglycemic reactions, injection site reactions, clinical laboratory tests, 12-lead ECG, vital signs, physical examination, and local tolerability at the injection site., From Predose to Day14 after a single dose
Secondary Outcome Measures: GIRmax, Maximum glucose infusion rate, From 0 hours to 24 hours after a single dose|AUCGZR33,0-24 h, Area under the plasma concentration curve of GZR33 from 0 to 24 hours, From Predose to Day8 after a single dose|AUCIAsp，0-12 h, Area under the plasma concentration curve of insulin aspart from 0 to 12 hours, From 0 hours to 12 hours after a single dose
Current Status of Treatment for Chinese Patients With ESR1-mutated HR+/HER2-advanced Breast Cancer
NCT Number: NCT06548919
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: ESR1 Gene Mutation|Advanced Breast Cancer
Interventions: DRUG: Endocrine therapy|DRUG: Chemotherapy Prednisone
Sponsor: SciClone Pharmaceuticals
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 450
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-08
Completion Date: 2027-12-31
Locations: Tianjin Haidafu Internet Hospital, Suzhou, Jiangsu, China

Summary:
This is a prospective, non-interventional real-world study to observe the efficacy and safety of different treatment regimens in patients with ESR1-mutated HR+/HER2-advanced breast cancer after failure of endocrine therapy.

Epidemiological data, efficacy and safety measures will be collected for each subject. Data on efficacy and safety assessment indicators will be collected every 2-3 months until disease progression, receipt of a new anti-tumour treatment modality, death, loss to follow-up, and arrival at the data collection cut-off date. The cut-off date for data collection is defined as 8 weeks after completion of 6 visits for each subject, or 4 weeks after treatment discontinuation and subject discontinuation/withdrawal. Subjects receiving a different treatment regimen remained subject to assessment of safety indicators 4 weeks after discontinuation of the original treatment regimen.

Primary Outcome Measures: PFS, Progression-free survival, 18 months
Secondary Outcome Measures: ORR, Objective response rate, 6 months|CBR, Clinical benefit rate, 6 months|DoR, Duration of response, 18 months
Other Outcome Measures: Adverse event rate, Percentage of occurrences of adverse events, 18 months|Serious adverse event rate, Percentage of occurrences of serious adverse events, 18 months|Treatment regimen, Proportion of endocrine therapy, endocrine-targeted combination therapy or chemotherapy, 18 months|Medication adherence, proportion of days covered, 18 months
A Study of GZR4 Injection at Different Injection Sites
NCT Number: NCT06548906
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Healthy Subjects
Interventions: DRUG: GZR4 Injection
Sponsor: Gan and Lee Pharmaceuticals, USA
Sex: MALE
Age: ADULT
Enrollment: 24
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-05-08
Completion Date: 2024-08-31
Locations: Study Site, Beijing, China

Summary:
This trial is conducted in China. This study is a randomized, single-center, open, three-period crossover trial in healthy subjects to compare the PK, PD, and safety of a single administration of GZR4 at different injection sites (abdomen, deltoid region of upper arm, and thigh).

Primary Outcome Measures: AUC0-672h, Area Under the Concentration Versus Time Curve of GZR4 Injection From Time Zero to 672 hours, From Predose to 672 hours after a single dose
Secondary Outcome Measures: AUC0-∞, Area Under the Concentration Versus Time Curve of GZR4 Injection From Time Zero to Infinity, From Predose to 672 hours after a single dose|Cmax, Maximum Concentration of GZR4 Injection, From Predose to 672 hours after a single dose
Acceptance and Commitment Therapy (ACT) in Groups for Obsessive Compulsive Disorder: A Clinical Trial in Brazil
NCT Number: NCT06548893
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Obsessive-Compulsive Disorder
Interventions: OTHER: Group acceptance and commitment therapy (ACT)
Sponsor: Universidade Federal do Paraná
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 24
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2022-08-10
Completion Date: 2026-06-20
Locations: Universidade Federal Do Paraná, Curitiba, Parana, 80060-900, Brazil

Summary:
The goal of this clinical trial is to learn if Acceptance and Commitment Therapy (ACT) + Exposure and Response Prevention (ERP) in Group is effective to Obsessive Compulsive Disorder (OCD) in adults.

Researchers will compare intervention to control group to see if those who attend the group therapy have better results than control group.

Participants will go through a 16-week group therapy based on a protocol designed by Michael Twohig (Twohig et al, 2018).

* Participants will not have any medication adjustment during therapy
* Participants will be assessed 3 times throughout the therapy, plus an assessment in a 6-month follow-up.

Primary Outcome Measures: Yale-Brown Obsessive-Compulsive Scale (YBOCS), Measure for assessing the presence and severity of obsessive-compulsive disorder (OCD) symptoms., 10 months (4-month intervention + 6-month follow-up)
Secondary Outcome Measures: Acceptance and Commitment Therapy Processes (CompACT), Measure of psychological flexibility, 10 months (4-month intervention + 6-month follow-up)|Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-SV), Measures of the degree of enjoyment and satisfaction experienced by subjects in various areas of dally functioning, 10 months (4-month intervention + 6-month follow-up)|Depression Anxiety and Stress Scale (DASS), Set of self-report scales designed to measure the emotional states of depression, anxiety and stress., 10 months (4-month intervention + 6-month follow-up)|AAQ for Obsessions and Compulsions (AAQ-OC), Self-report measure of experiential avoidance in response to unwanted intrusive thoughts., 10 months (4-month intervention + 6-month follow-up)|Affective Style Questionnaire (ASQ), Brief instrument to measure individual differences in emotion regulation, 10 months (4-month intervention + 6-month follow-up)|Clinical Global Impressions (CGI) Scale,, Quantify and track patient progress and treatment response over time., 10 months (4-month intervention + 6-month follow-up)
Retrospective Analysis of Patients With Metastatic Renal Cell Carcinoma Treated With CABOzantinib
NCT Number: NCT06548867
Acronym: CABOGEN
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Metastatic Renal Cell Carcinoma
Interventions: DRUG: Cabozantinib
Sponsor: Gruppo Oncologico Italiano di Ricerca Clinica
Collaborators: Yghea|Ipsen
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-05-28
Completion Date: 2025-06-30
Locations: AUSL-IRCCS of Reggio Emilia, Reggio Emilia, 42123, Italy

Summary:
CABOGEN is a Observational, retrospective, multicenter study that will enroll patients with metastatic clear cell renal carcinoma (mccRCC) treated with cabozantinib after one or more previous lines of treatment that included TKIs, immune checkpoint inhibitors or mTOR inhibitors.

Primary Outcome Measures: Genomic profiling, to describe genomic profiling of patients with mRCC who are long-lasting responders (PFS ≥9 months) to cabozantinib and describe genomic profiling of patients with rapid disease progression following cabozntinib therapy (PFS≤ 3 months), 12 months
Secondary Outcome Measures: Overall Survival (OS), to describe OS based according to detected genomic profiling, 12 months|Overall response rate (ORR), to describe ORR according to the detected genomic profiling, 12 months|Duration of response (DOR), to describe duration of response (DOR) according to the detected genomic profilingto describe the genomic profiling according to treatment line (second, third or subsequent) to describe anamnestic characteristics (weight, ECOG PS, sites of metastasis, response to previous treatment lines), 12 months
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Dose Exploration Clinical Trial Evaluating the Efficacy, Safety, and Pharmacokinetic Characteristics of STC314 Injection Administered Intravenously in Sepsis Patients
NCT Number: NCT06548854
Acronym: Sepsis
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Sepsis
Interventions: DRUG: STC314 Injection/STC314 Injection Placebo
Sponsor: Grand Medical Pty Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 180
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2023-11-20
Completion Date: 2025-02-28
Locations: Zhongda Hospital Southeast University, Nanjing, Jiangsu, 210009, China

Summary:
One study evaluated the efficacy and safety of intravenous STC314 injection in patients with sepsis Sex and pharmacokinetic profiles of a multicenter, randomized, double-blind, placebo-controlled II Phase I dose exploration clinical trial

Primary Outcome Measures: Changes in sequential organ failure (SOFA) scores from baseline on day 7 value, Changes in sequential organ failure (SOFA) scores from baseline on day 7 value, 7 days after the first dose
Development and Validation of (Bio)Sensors for the Identification of Pathogens
NCT Number: NCT06548841
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Infections|Infection, Bacterial|Infection Viral|Infection, Parasite|SARS CoV 2 Infection|Pseudomonas Aeruginosa Infection|Leishmania Infantum Disease
Interventions: OTHER: Nanobiotechnology platforms
Sponsor: University of Bologna
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-05-30
Completion Date: 2025-11-02
Locations: Department of Medical and Surgical Sciences, University of Bologna, Bologna, 40138, Italy

Summary:
The recent COVID-19 pandemic has revealed the need to develop tests that are accurate, rapid, and inexpensive for the diagnosis of infectious diseases. This problem is relevant not only for viruses, but also for bacteria and parasites: the identification of pathogens at low concentrations by simple and accurate methods is still largely unsatisfied because these microorganisms are structurally complex and are incorporated in composite and diverse biological samples, which can create relevant interferences in pathogens' detection. Direct diagnostic approaches, such as microscopic examination, culture and molecular testing are carried out in equipped laboratories and require long waiting times to obtain the results. Recently developed point-of-care (POC) tests are a group of technologies that miniaturize tests into portable devices such that they can be performed both in well-equipped laboratories and outside the conventional laboratory setting. The present study aims to explore the feasibility and adaptability of newly developed platforms to detect: 1. a virus (SARS-CoV2), 2. a bacterium (Pseudomonas aeruginosa) and 3. a protozoan parasite (Leishmania infantum) in clinical specimens, such as blood and respiratory samples. These newly developed platforms are expected to overcome the current limitations of molecular testing (high cost, time required and need for well-equipped laboratories) and rapid testing (high number of false-negative results). In addition, the newly developed platforms may have important clinical application in low-income countries, which will benefit from a simple and inexpensive approach to detect the many infectious diseases that affect millions of people each year.

Primary Outcome Measures: The evaluation of the sensitivity and specificity of new nanobiotechnological platforms compared to gold standard diagnostic tests, The sensitivity and the specificity will be estimated by creating the confusion matrix corresponding to the classification between signals significant (beyond Limit Of Detection, LOD) and samples giving non-significant signals (below LOD).

Where the analytical problem is described by other variables than the electrochemiluminescent analytical signal, multivariate classification methods shall be applied. The correlation and interaction between variables will also be estimated., 16 months
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single-dose GZR4
NCT Number: NCT06548815
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Diabetes
Interventions: DRUG: GZR4|DRUG: Placebo
Sponsor: Gan and Lee Pharmaceuticals, USA
Sex: MALE
Age: ADULT
Enrollment: 43
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2022-08-29
Completion Date: 2023-03-24
Locations: Gan & Lee Pharmaceuticals Co., Ltd, Beijing, Beijing, 100000, China

Summary:
This trial is conducted in China. The aim of this trial is to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of single-dose GZR4.

Primary Outcome Measures: Incidence of TEAE, Baseline to Day29
Secondary Outcome Measures: GIRmax, Day2-Day3|Tmax,GIR, Day2-Day3|AUCGIR, Day2-Day3/Day7-Day8|Cmax, Baseline to Day29|Tmax,GZR4, Baseline to Day29|T1/2, Baseline to Day29|AUC0-inf, Baseline to Day29|AUC0-last, Baseline to Day29
Neoadjuvant Immune Checkpoint Blockade + a Prebiotic Food-enriched Dietary Intervention to Optimize Immune Response in Melanoma: NEO-PreFED
NCT Number: NCT06548789
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Melanoma
Interventions: DIETARY_SUPPLEMENT: Prebiotic Xnack Packouts
Sponsor: M.D. Anderson Cancer Center
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 35
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-12-31
Completion Date: 2030-09-01
Locations: MD Anderson Cancer Center, Houston, Texas, 77030, United States

Summary:
To Determine the feasibility, compliance and adherence to PreFED intervention in resectable melanoma patients initiating neoadjuvant Ipi/Nivo.

Primary Outcome Measures: The completion rate, compliance and adherence., The completion rate is defined as proportion of participants completed the intervention. Among subjects that complete the PreFED intervention, compliance is defined as the proportion (%) of prebiotic snacks consumed versus provided and proportion (%) of counselling sessions attended, while adherence is defined as the number of servings of prebiotic foods the participant consumed., Up to 2 years
Establishing Daily Applicable Parameters for Using Magnetic Resonance Spectroscopy of Spinal Cord
NCT Number: NCT06548776
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Spinal Cord
Interventions: DIAGNOSTIC_TEST: Magnetic Resonance Spectroscopy (MRS) Scan
Sponsor: M.D. Anderson Cancer Center
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 13
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-12-01
Completion Date: 2027-07-31
Locations: MD Anderson Cancer Center, Houston, Texas, 77090, United States

Summary:
To learn if MRS can effectively assess spinal cord lesions.

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), Through study completion; an average of 1 year.
Oral Topotecan With Toripalimab for Patients With Endometrial Cancer
NCT Number: NCT06548763
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Endometrial Cancer
Interventions: DRUG: Topotecan|DRUG: Toripalimab
Sponsor: Fudan University
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-11-30
Completion Date: 2026-12-31
Locations: Fudan university shanghai cancer center, Deparment of gynecologic oncology, Shanghai, Shanghai, 200032, China

Summary:
This study aims to explore the safety and efficacy of oral topotecan combined with toripalimab in treating advanced/recurrent endometrial cancer through a single-center, prospective, single-arm, phase II clinical trial. The goal is to explore the first-line treatment options for endometrial cancer patients in the era of immunotherapy, to improve the overall treatment level and prognosis of endometrial cancer.

Primary Outcome Measures: PFS, Progression free survival, Two years
Secondary Outcome Measures: OS, Overall Survival, Two years|ORR, Overall Remission Rate, Two years
Other Outcome Measures: Tumor markers, Substances that can reflect the occurrence and development of tumors, and monitor tumor response to treatment, including CA125, HE4, CA199, CA153, and CEA, Two years
Clinical Outcomes Following Primary Intracerebral Hemorrhage
NCT Number: NCT06548737
Acronym: COPI
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Stroke|Intracerebral Hemorrhage
Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators: The People's Hospital of Haiyan|Taizhou First People's Hospital|The First People's Hospital of Pinghu|The 2nd People's Hospital of Quzhou
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 25000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2016-10-27
Completion Date: 2033-12-31
Locations: The Second Affiliated Hospital of Zhejiang University, Hangzhou, Zhejiang, 310009, China

Summary:
The investigators design an observational multi-center cohort study to provide contemporary information on the prevalence, characteristics, risk stratification，cost-effective ,treatments and prognosis of Chinese hospitalized adult patients with primary intracerebral hemorrhage.

Primary Outcome Measures: All-cause death, Patients die of any reasons, 5 years after ICH|ICH recurrence, Patients had an another ICH after this ictus, 5 years after ICH|3-month outcome, 3-month outcome is measured using modified Rankin Scale (mRS) score, 3 months after ICH
Secondary Outcome Measures: hematoma volume, The volume of hematoma according to CT scan at the baseline when patients arrived at the emergency room, up to 5 hours (A few hours after ICH)|hematoma expansion, Patients had another CT scan during 24-48 hours after the first CT, and hematoma volume growth exceeding 33% or absolute hematoma growth exceeding 6ml, within 48 hours after ICH|cerebral small vessel diseases (CSVDs), cerebral small vessel diseases evaluated by MRI, including cortical superficial siderosis (cSS), white matter hyperintensity (WMH), cerebral microbleed (CMB), etc., within 2 weeks after ICH
Patient's Quality of Life and Functional Changes After Fistula Surgery
NCT Number: NCT06548724
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Anal Fistula
Interventions: OTHER: assessment of quality of life before and after anal surgery
Sponsor: Mansoura University Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 70
Study Design: Observational Model: |Time Perspective: p
Start Date: 2021-08-01
Completion Date: 2024-12
Locations: Mansoura university hospital, Mansoura, Dakahlyia, 35516, Egypt

Summary:
This is a prospective observational study that will monitor the effects of surgery for anal fistula on the patient quality of life using many valid questionnaires

Primary Outcome Measures: patient quality of life changes before and after surgery with QoLAF-Q, To Evaluate the impact of the fistula surgery on quality of life , the range range between 14 points which means zero impact on the quality of life and 70 which is the highest impact of anal fistula on the quality of life functional aspect in form of incontinence and quality of life of the patient, after 1 and 3 and 6 months
Secondary Outcome Measures: the validation of arabic translation of the quesionaire, The validation of the arabic translation of the questionaire will be done to establish a avalidated form in arabic that can be easily undrestandable for arabic population . it will be done on part of participants in a time frame of 4 to 5 months QoLAF-Q. In addition, postoperative pain, state of continence, manometric changes, operation time, time to healing, and postoperative complications, 3 and 5 months
Effect of Transcutaneous Acupoint Electrical Stimulation (TAES) on Postoperative Cough in Lung Cancer
NCT Number: NCT06548711
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Postoperative Cough|Lung Cancer
Interventions: OTHER: Transcutaneous Acupoint Electrical Stimulation (TAES)
Sponsor: Kong Fanming
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 120
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-04-17
Completion Date: 2026-06-17
Locations: First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin, Tianjin, 300193, China

Summary:
Observation and exploration of the improvement in cough symptoms in postoperative lung cancer patients with Transcutaneous Acupoint Electrical Stimulation (TAES), the change in Cough Symptom Score (CSS) compared to baseline, the change in Visual Analog Scale (VAS) score for cough symptoms compared to baseline, the change in total score of Leicester Cough Questionnaire-Mandarin Chinese version (LCQ-MC) compared to baseline, and overall evaluation of treatment effectiveness by patients. A total of 120 postoperative lung cancer patients with cough were strictly selected according to the inclusion/exclusion criteria and treated and followed up according to the research plan requirements. Clinical observation forms were completed and clinical data were recorded in the database. Statistical analysis was performed on relevant clinical observation indicators to report research results and write related papers.

Primary Outcome Measures: LCQ-MC, The questionnaire consists of 19 items, each of which is divided into 7 levels according to the severity, including the impact of chronic cough on the physiological domain (chest pain, cough, sputum, fatigue, sleep, hoarseness, etc.), psychological domain (feeling embarrassed, anxious, depressed, annoyed, etc.), and social domain (work, daily life, leisure activities, conversation, phone calls, interference with friends or family members). The score for each domain is the total score of each item in that domain divided by the number of questions (scored from 1 to 7), and the total score is the sum of the scores for the three domains (scored from 3 to 21). A higher score represents a better patient's health condition., Prior to treatment (baseline), at the end of treatment (week 2), and 2 weeks after the end of treatment (week 4)
The Impact of Escape Room Experience in Nursing Students
NCT Number: NCT06548698
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Nursing Education
Interventions: OTHER: escape room
Sponsor: TC Erciyes University
Sex: ALL
Age: ADULT
Enrollment: 43
Study Design: Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-05-06
Completion Date: 2024-08-15
Locations: Erciyes University Faculty of Health Sciences, Kayseri, 38000, Turkey

Summary:
Gamification is an applied, team-based approach in which students are actively involved. This study was conducted to evaluate the effect of escape room experience on the level of problem solving skills and professional behavior in nursing students.

This study was completed in a randomized controlled trial with 43 final year nursing students from a university. Students were randomized into intervention (n=22) and control (n=21) groups. In this study, data were collected with the Game Experience Scale, Problem Solving Inventory, and Nursing Students Professional Behavior Scale. The data obtained from the study were evaluated with SPSS 24.0. Descriptive statistics; number (n), percentage (%), mean (X), standard deviation (SD) were given. Statistical significance level was evaluated as p\<0.05. The students in the intervention group analyzed the breast cancer surgery case with the escape room experience. The students were divided into groups of 5 and tried to complete the tasks given by the researchers within 30 minutes. During the escape room practice, the researchers were present in the rooms as observers and evaluated the participants.

Primary Outcome Measures: Problem solving level, The problem solving levels of nursing students will be evaluated using the problem solving inventory in the first week and the last week of the 5-week follow-up period., 5 week|professional behavior level, The professional behavior levels of nursing students will be evaluated using the Professional Behavior Scale for Nursing Students in the first and last week of the 5-week follow-up period., 5 week
Vegetable Ivory Bone Material in Bone Healing Compared to Current Standard Methods of Bone Healing
NCT Number: NCT06548685
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Bone Volume
Interventions: PROCEDURE: Bone Grafting|OTHER: Vegetable Derived
Sponsor: Mark Stanczyk
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 5
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2024-09
Completion Date: 2025-11

Summary:
The purpose of this research study is to evaluate whether a biobased natural vegetable ivory formulation can produce similar or better results compared to the current standard bone healing treatment.

Primary Outcome Measures: Number of participants with completely healed bone graft surgical site, The number of participants who have bone volumes that match or exceed the control sites., Six Months
The Immediate Extent of the Hypoalgesic Effect Following Central Mobilisations to L3, L4 and L5
NCT Number: NCT06548633
Acronym: HypoLumbar
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Low Back Pain
Interventions: OTHER: Lumbar Vertebral Mobilisation
Sponsor: Darren Cooper
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2018-10-04
Completion Date: 2019-05-28
Locations: University of Worcester, Worcester, Worcestershire, WR5 3WP, United Kingdom

Summary:
The aim of this study was to establish the efficacy of spinal mobilisations (a controlled application of a specific amount of force to a targeted spinal level) for reducing pain across different areas of the lower back. Pain was assessed using a pin prick sensation device and recorded in specific locations by the participant using a 10 cm line with one end indicating no pain and the other the worst pain possible.

Primary Outcome Measures: Pinprick sensitivity (PPS), Using a Neuropen® (Owen Mumford, Oxfordshire, UK) a standardised force of 40g was applied to one of the dermatome locations. The participant then received a small piece of card with a vertical 10cm visual analogue scale (VAS) line on it and a pen and was asked to "draw a horizontal line on the scale to indicate how much sensation you feel, 0 being can-not feel anything and 10 being an extremely strong sensation". Following this explanation, the participant was asked if they understood and whether they needed further instruction to complete the VAS card. Once the participant marked the card, the card and pen were collected and stored, this process was repeated with the remaining four locations (these five cards provided the baseline data). A new tip was used for each participant, and a decrease in PPS represents a reduction in pain., Up to 15 minutes
A Study of RD06-04 in Patients With Active Autoimmune Diseases
NCT Number: NCT06548620
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: EARLY_PHASE1
Conditions: SLE (Systemic Lupus)|Sclerosis|ANCA Associated Vasculitis|IIM|SS|MS|NMO Spectrum Disorder|MG
Interventions: DRUG: RD06-04 cell infusion
Sponsor: Nanjing Bioheng Biotech Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 18
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-31
Completion Date: 2027-08-31
Locations: The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, 461499, China

Summary:
This is an open-label, Phase I, investigator-initiated trial (IIT) aimed at evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of RD06-04 in patients with autoimmune diseases mediated by autoantibodies. The study population includes patients with Systemic Lupus Erythematosus (SLE), Systemic Sclerosis (SSc), ANCA-Associated Vasculitis (AAV), Idiopathic Inflammatory Myopathy (IIM), Sjögren's Syndrome (SS), Multiple Sclerosis (MS), Neuromyelitis Optica Spectrum Disorder (NMOSD), and Myasthenia Gravis (MG).

Primary Outcome Measures: Incidence of treatment-emergent adverse events, serious adverse events and incidence of adverse events of special inte rest, TEAEs.SAE.AESI, up to 2 years
Clinical Study on Targeted CD19 CAR-T Therapy for Autoimmune Diseases
NCT Number: NCT06548607
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: EARLY_PHASE1
Conditions: SLE (Systemic Lupus)|Systemic Sclerosis|ANCA Associated Vasculitis|Idiopathic Inflammatory Myopathies|Sjogren's Syndrome|Autoimmune Diseases
Interventions: DRUG: RD06-04 CART Cell Injection
Sponsor: Nanjing Bioheng Biotech Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-29
Completion Date: 2027-07-29
Locations: The Third the People's Hospital of Bengbu, Bengbu, Anhui, 233000, China

Summary:
This is an open clinical pharmacological translational Research Study, aiming to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of RD06-04 in patients with active SLE, SSc, AAV, IIM and pSS.

Primary Outcome Measures: The incidence of adverse events (TEAEs), serious adverse events (SAEs), and adverse events of particular concern (AESI) during treatment, 2 years
Out of State - tAN hEDS
NCT Number: NCT06548594
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Hypermobile EDS (hEDS)
Interventions: DEVICE: Transcutaneous Auricular Neurostimulation
Sponsor: Medical University of South Carolina
Collaborators: MUSC Blue Sky initiative
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 10
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-20
Completion Date: 2025-08-05

Summary:
Hypermobile EDS and hypermobile spectrum disorder (collectively referred to as hEDS) are estimated to affect 1 in 500 individuals worldwide. hEDS patients have limited treatment options for their numerous symptoms that impact the quality of life. This clinical trial tests a new ear stimulation method in hEDS patients to determine if it may improve quality of life.

Primary Outcome Measures: Ehlers-Danlos Syndrome Symptom Battery, The investigators have created an Ehlers-Danlos Syndrome Symptom Battery that measures a variety of different primary and secondary symptoms associated with Ehlers-Danlos Syndrome, including: Pain, Fatigue, Sleep, Anxiety, Depression, Quality of Life, and Gastrointestinal issues., 4 weeks
A Real-world Study to Assess Safety of OZURDEX® (Dexamethasone Intravitreal Implant) in Adult Participants With Diabetic Macular Edema in China
NCT Number: NCT06548568
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Diabetic Macular Edema
Sponsor: AbbVie
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 110
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-10-30
Completion Date: 2027-05-30

Summary:
The dexamethasone intravitreal implant (OZURDEX) delivers dexamethasone gradually to the retina over time. It is an approved drug for the treatment of diabetic macular edema (DME). This study will assess the long-term safety and effectiveness of OZURDEX in adult participants with DME in the routine clinical setting in China.

Approximately 110 participants who are prescribed OZURDEX by their physicians will be enrolled in multiple medical institutions in China where OZURDEX is used for DME in routine clinical practice.

Participants will be followed for 24 months after the first administration of OZURDEX according to the routine clinical practice of the prescribing centers. A subsequent 30-day follow-up after the last dose will be performed to obtain information on any new or ongoing safety events and concomitant medications.

No additional burden for participants in this trial is expected.

Primary Outcome Measures: Number of Participants with Treatment Emergent Adverse Events (TEAEs), including Adverse Events of Special Interest (AESIs), An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The AESIs can include the following: cataracts, elevated IOP and conjunctival hemorrhage., Up to approximately 24 months