pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Transcatheter Arterial Embolization for Elbow and Foot Plantar Pain
NCT Number: NCT06523114
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Elbow Tendinitis|Elbow Tendinopathy|Epicondylitis of the Elbow|Epicondylitis, Lateral|Plantar Fascitis|Embolization
Interventions: DEVICE: Transcatheter Arterial Embolization
Sponsor: Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Collaborators: Dongkook Pharmaceutical Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 13
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2022-04-18
Completion Date: 2024-12
Locations: Chung-Ang University Hospital, Seoul, 06973, Korea, Republic of

Summary:
This is a prospective single arm study in which patients with moderate to severe chronic elbow or foot plantar pain, in the setting of lateral epicondylitis or plantar fascitis refractory to conservative treatment, will be enrolled.

The primary aim of this study is to estimate the effectiveness and safety of transcatheter arterial embolization (TAE) for changes in elbow or plantar pain with 6 and 12-month follow-up.

Primary Outcome Measures: Visual Analog Scale Pain (VAS) Score, At 1 week, 1 month, 3 months, 6 months, and 12 months after the procedure, the degree of pain (visual analog scale pain, 10 points for maximum pain, 0 points for no pain) is assessed through an outpatient visit or by phone., 1,3,6,12 month
Secondary Outcome Measures: Adverse Events, Compare the safety of TAE by recording adverse events at 1 month, 3 months, 6 months, and 12 months post intervention, 1,3,6,12 month
A Study of PJ009 in Healthy Adult Volunteers
NCT Number: NCT06523101
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Short Bowel Syndrome
Interventions: DRUG: PJ009|DRUG: Placebo
Sponsor: Chongqing Peg-Bio Biopharm Co., Ltd.
Sex: ALL
Age: ADULT
Enrollment: 24
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2023-02-28
Completion Date: 2023-05-15
Locations: The Second Hospital of Shanxi Medical University, Taiyuan, Shanxi, 030001, China

Summary:
The main aim of this clinical trial is to assess the safety of PJ009 in healthy adult volunteers aged 18-45. The main questions it aims to answer are:

* Is PJ009 safe in healthy adult? Participants will
* Receive single dose of PJ009 or placebo according to weight, and then multiple doses daily for 7 days,
* Stay in hospital for assessment.

Primary Outcome Measures: Treatment-related Adverse Events, Number of participants with treatment-related adverse events during the study will be collected and the percentage of adverse events (AEs) of different grades as assessed by CTCAE v5.0 will be assessed., Up to 18 days
A Phase 1a Study of PN20 in Healthy Adult Volunteers
NCT Number: NCT06523088
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Chemotherapy-induced Thrombocytopenia|Immune Thrombocytopenic Purpura
Interventions: DRUG: PN20|DRUG: Placebo
Sponsor: Chongqing Peg-Bio Biopharm Co., Ltd.
Sex: ALL
Age: ADULT
Enrollment: 27
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2022-06-16
Completion Date: 2023-01-05
Locations: The First Affiliated Hospital of Soochow University, Suzhou, Jiangshu, 215006, China

Summary:
The main aim of this clinical trial is to assess the safety of PN20 in healthy volunteers aged 18 to 50 years. The main questions it aims to answer are:

* Is PN20 safe in adult? Researchers will compare PN20 to a placebo (a look-alike substance that contains no drug) to see if PN20 is safe.

Participants will

* Receive a single dose injection of PN20 or placebo according to weight,
* Stay in hospital for assessment.

Primary Outcome Measures: Treatment-related Adverse Events, Number of participants with treatment-related adverse events during the study will be collected and the percentage of AE of different grades as assessed by CTCAE v5.0 will be assessed., up to 15 days
Host Dysregulation-Driven Sepsis Prediction Model
NCT Number: NCT06523075
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Sepsis
Interventions: OTHER: Tumor Necrosis Factor|OTHER: Interleukin-1β|OTHER: Interleukin-12|OTHER: Interleukin-18|OTHER: Complement C3|OTHER: Complement C5
Sponsor: Second Affiliated Hospital of Wenzhou Medical University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-01
Completion Date: 2025-12-31
Locations: The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University,, Wenzhou, Zhejiang, 325027, China

Summary:
The aim of this study is to identify risk factors associated with sepsis and to construct a predictive model for sepsis. This will provide an objective theoretical and empirical foundation for the diagnosis, assessment, and management of sepsis in our country.The primary questions addressed are:

What are the risk factors for the development of sepsis? How do we improve the prognosis of sepsis?

Primary Outcome Measures: Sepsis, A rapid increase of 2 or more points points in the Sequential Organ Failure Assessment (SOFA) score after patient infection., 3 months
Short Term Reproducibility of Office White-coat Effect
NCT Number: NCT06523062
Acronym: REBBRE
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: White Coat Hypertension
Interventions: DEVICE: blood pressure measurement
Sponsor: University Hospital, Caen
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 922
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: SINGLE (PARTICIPANT)|Primary Purpose: DIAGNOSTIC
Start Date: 2024-09-01
Completion Date: 2025-08-31

Summary:
While a theoretical increase in systolic blood pressure (BP) of 10 mmHg can triple the relative risk of cardiovascular disease (CVD), the potential presence of a white coat effect (WCE) can interfere with the assessment of blood pressure control in the consultation. However, it is often difficult to assess the presence of a white coat effect (a quantitative variable) in general practice because of the difficulties in performing ambulatory BP measurements (self-measurement of blood pressure or ambulatory BP measurements). We have therefore previously described a surrogate concept of WCE obtained during a consultation with a general practitioner. It corresponds to a reduction of 10mmHg or more in systolic BP between the start and the end of the consultation. We have named it 'office white coat effect tail' (OWCET) and we have shown that OWCET, as a dichotomous variable, in a large Italian population cohort, with a follow-up of more than 18 years, was associated with an excess incidence of stroke, myocardial infarction (MI) and CVD and with excess mortality from MI and CVD. This concept appears to be more prevalent in women and is independent of blood pressure variability (regression to the mean). In addition, there is a genuine correlation between WCE and OWCET. To our knowledge, the reproducibility of the OWCET has never been studied, which could distort the relevance of this concept in the context of cardiovascular risk stratification in primary care.

Primary Outcome Measures: OWCET, Measurement of OWCET on two occasions during two consultations separated by one month, using the same automated blood pressure monitor, in order to estimate an intraclass kappa coefficient (qualitative measurement)., 1 month
Secondary Outcome Measures: Factors associated with reproducibility of OWCET, Patients characteristics, 1 month|Different definitions of OWCET, Variation of OWCET definition in order to test OWCET reproducibility, 1 month|blood pressure Variability, To test impact of blood pressure variability, 1 month
Vorolanib Plus Sintilimab for Advanced Renal Cell Carcinoma After Failure of Prior Immune Checkpoint Inhibitors Based Combination Therapy
NCT Number: NCT06523049
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Renal Cell Carcinoma|Immunotherapy|Molecular Targeted Therapy
Interventions: DRUG: Vorolanib Tablets|DRUG: Sintilimab Injection
Sponsor: Hao Zeng
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 67
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2026-09
Locations: West China Hospital, Chengdu, Sichuan, 610000, China

Summary:
This Phase II trial assesses Vorolanib and Sintilimab for advanced renal cell carcinoma after previous therapy failure. Participants receive the treatment until disease progression, intolerable side effects, death, or withdrawal. The primary endpoint is progression-free survival (PFS).

Primary Outcome Measures: Progression-Free Survival (PFS), Progression-free survival is assessed by investigators based on RECIST1.1, including disease progression or death from any cause., 3 years
Secondary Outcome Measures: Objective Response Rate (ORR), Objective response rate is the proportion of participates with complete response (CR) or partial response (PR), based on RECIST1.1., 3 years|Overall Survival (OS), Overall survival is the time from starting treatment to still being alive., 3 years|Adverse Events (AEs), Adverse events are the incidence of treatment-emergent adverse events as assessed by CTCAE v5.0, including type and severity., 3 years|Disease Control Rate (DCR), Disease control rate is the proportion of participates with complete response (CR), partial response (PR) or stable disease (SD), based on RECIST1.1., 3 years|Duration of Response (DoR), Duration of response is the time from first response (complete or partial response) to disease progression or death., 3 years|Quality of Life (QoL) assessed by FKSI-19, Quality of life is assessed by FKSI-19, 3 years|Quality of Life (QoL) assessed by EQ-5D-5L, Quality of life is assessed by EQ-5D-5L., 3 years|Pain Score, Evaluate pain using visual analogue scale (VAS), range from 0 to 10, higher scores predict a poor prognosis., 3 years
Fractional Erbium YAG Laser vs Intradermal and Systemic Tranexamic Acid
NCT Number: NCT06522984
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Refractory Melasma
Interventions: DRUG: Tranexamic acid injection
Sponsor: Egymedicalpedia
Collaborators: Aswan University
Sex: ALL
Age: ADULT
Enrollment: 45
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-01
Completion Date: 2025-06-10
Locations: Aswan University hospitals, Aswan, Egypt

Summary:
Melasma is a common acquired disorder of hyperpigmentaion caused by increased melanin production by melanocytes.

Melasma is a name derived from the Greek word melas meaning black.It is characterized by the appearance of brownish or grayish symmetrical patches on sun-exposed skin, most commonly on the face. Compared to men, women are more likely to be affected.

Primary Outcome Measures: Refractory Melasma Treatment combination with topical hydroquinone, to detect the treatment response by YAG laser vs intradermal and systemic tranexamic acid by using The MASI index ( MASI is an index designed to quantify the severity of melasma during therapy)., 3 months
To Evaluate the Pharmacokinetics and Safety of TQD3524 for Injection in Renal Impairment Subjects
NCT Number: NCT06522945
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Multi-resistant Gram-negative Bacteria Cause Infection
Interventions: DRUG: TQD3524|DRUG: TQD3524|DRUG: TQD3524|DRUG: TQD3524|DRUG: TQD3524|DRUG: TQD3524
Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 48
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07
Completion Date: 2025-03

Summary:
This is an open, open-label, parallel, single-dose, phase I clinical study designed to evaluate the pharmacokinetic (PK) profile of TQD3524 injection in patients with renal impairment after a single dose, and to evaluate the urinary excretion of the drug in these patients after a single dose, as well as to evaluate the safety of the drug in these patients after a single dose.

Primary Outcome Measures: Peak concentration (Cmax), Maximum plasma drug concentration, Before administration, 1.75 , 2 , 2 .5, 3.5, 5 , 7 , 9,12 , 16, 24 hours after administration|Area under the concentration-time curve (AUC), Area under the plasma concentration-time curve, Before administration, 1.75 , 2 , 2 .5, 3.5, 5 , 7 , 9,12 , 16, 24 hours after administration|Time-to-maximum concentration (Tmax), Time-to-maximum concentration, Before administration, 1.75 , 2 , 2 .5, 3.5, 5 , 7 , 9,12 , 16, 24 hours after administration|Plasma half life (t1/2), The time it takes for the concentration or amount in the body of that drug to be reduced by exactly one-half, Before administration, 1.75 , 2 , 2 .5, 3.5, 5 , 7 , 9,12 , 16, 24 hours after administration|Total body clearance (CLt), Total body clearance of TQD3524, Before administration, 1.75 , 2 , 2 .5, 3.5, 5 , 7 , 9,12 , 16, 24 hours after administration|Renal clearance (CLr), Renal clearance of TQD3524, Before administration, 1.75 , 2 , 2 .5, 3.5, 5 , 7 , 9,12 , 16, 24 hours after administration|Apparent volume of distribution (Vd/F), Volume of distribution based on the terminal phase, Before administration, 1.75 , 2 , 2 .5, 3.5, 5 , 7 , 9,12 , 16, 24 hours after administration|Terminal elimination rate (λz), First-order rate constant associated with the terminal (log-linear) elimination phase, Before administration, 1.75 , 2 , 2 .5, 3.5, 5 , 7 , 9,12 , 16, 24 hours after administration|Mean residence time (MRT), The average time that the drug stays in the body, Before administration, 1.75 , 2 , 2 .5, 3.5, 5 , 7 , 9,12 , 16, 24 hours after administration
Secondary Outcome Measures: Amount Excreted in Urine as Unchanged Drug or Metabolite (Ae0-24), Ae0-24 of TQD3524 and the active ingredients in urine, Before administration, 1.75 , 2 , 2 .5, 3.5, 5 , 7 , 9,12 , 16, 24 hours after administration|Adverse event rate, The occurrence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs)., Baseline up to 72 hours
PET Imaging Study of 64Cu-GRIP B for Patients Receiving CD19-directed CAR-T Therapy
NCT Number: NCT06522932
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Non Hodgkin Lymphoma
Interventions: DRUG: 64Cu-GRIP B|PROCEDURE: Positron Emission Tomography (PET)|PROCEDURE: Optional tumor biopsy
Sponsor: C. Babis Andreadis
Collaborators: The V Foundation
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 32
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-08-30
Completion Date: 2027-01-31
Locations: University of California, San Francisco, San Francisco, California, 94143, United States

Summary:
This is a phase I/Ib imaging study of granzyme B, 64-copper granzyme targeting restricted interaction peptide specific to family member B (64Cu-GRIP B) Positron Emission Tomography (PET) in patients with relapsed/refractory non-Hodgkin's lymphoma (NHL) receiving CD19-directed Chimeric antigen receptor T cells (CAR-T) therapy. The proposed study represents the first-ever lymphoma patient imaging studies with 64Cu-GRIP B PET. The tracer is designed to detect extracellular granzyme B as it is secreted by activated immune cells in the tumor microenvironment, which may highlight tumors that will exhibit a durable response to Cluster of Differentiation 19 (CD19)-directed CAR T-cell therapy.

Primary Outcome Measures: Proportion of positive tumors at the post-CAR-T scan, The proportion of known lesions with detectable radiotracer uptake on conventional imaging will be reported along with 95% binomial exact confidence intervals. Tumors will be defined as positive if they are focally avid with maximum standardized uptake value (SUVmax) \>1.5 fold above adjacent background., From prior to CAR-T to Day 22 following CAR-T cell, approximately 32 days total
Secondary Outcome Measures: Mean SUVmax by disease site, The mean/sd (median and range, if normality assumption does not hold) for intra-tumoral SUVmax within lesions will be descriptively reported, to assess for intra-tumoral heterogeneity and differences in uptake by site of disease., From prior to CAR-T to Day 22 following CAR-T cell, approximately 32 days total|Overall Mean SUVmax by cohort, The mean/sd (median and range, if normality assumption does not hold) for inter-participant SUVmax within lesions will be descriptively reported, to assess for inter-participant heterogeneity and differences in uptake., From prior to CAR-T to Day 22 following CAR-T cell, approximately 32 days total|Percent of lymphoma lesions detected, The percentage of lesions detected on conventional imaging that are detected on baseline 64Cu-GRIP B PET will be descriptively reported., From prior to CAR-T to Day 22 following CAR-T cell, approximately 32 days total|Frequency and severity of treatment-emergent adverse events, Frequency and severity of treatment adverse events following 64Cu-GRIP B injection classified according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v 5.0)., Up to 13 months
Cytomegalovirus (CMV) Transmission and Immune Tracking (TransmIT) Study
NCT Number: NCT06522880
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Cytomegalovirus Infections
Interventions: DIAGNOSTIC_TEST: CMV PCR on saliva
Sponsor: University of Massachusetts, Worcester
Collaborators: ModernaTX, Inc.
Sex: ALL
Age: CHILD
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-08-10
Completion Date: 2027-12-31
Locations: UMass Chan Medical School, Worcester, Massachusetts, 01655, United States

Summary:
The goal of STAGE I of the CMV TransmIT Study is to determine the prevalence of CMV shedding in children up to and including 36 months of age in large group childcare centers and in staff who regularly work at the center. Participants will complete a health survey and provide one saliva sample for CMV PCR testing. In addition, infrastructure for the study will be developed (e.g. community engagement to build the network of centers, data pipelines, digital platform, sampling workflows) and participant sample collection at home will be piloted. These activities will inform the design of STAGE II.

Primary Outcome Measures: Prevalence of CMV shedding, Prevalence of CMV shedding in children and childcare center staff. Shedding measured by CMV PCR on saliva., Stage I up to 2 years
Evaluation of Intraocular Pressure Following a Vitreoretinal Surgery Using Goldmann Applanation Tonometry, Icare and Accupen
NCT Number: NCT06522867
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Intraocular Pressure
Interventions: OTHER: Intraocular pressure measure
Sponsor: CHU de Quebec-Universite Laval
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 67
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-08
Completion Date: 2027-08-01
Locations: Hôpital du Saint-Sacrement, CHU de Québec - Université Laval, Québec, G1S4L8, Canada

Summary:
The goal of this prospective controlled study is to measure the reliability of two intraocular pressure (IOP)-measuring instruments in comparison to the gold standard, Goldmann applanation tonometry (GAT) following vitreo-retinal surgery. The main question the current study aims to answer is: are Icare and Accupen as accurate as GAT in measuring IOP one day post eye surgery?

Participants in this study will have their IOP measured by the three different instruments one day post-surgery.

Primary Outcome Measures: Absence of difference between intracular pressure measured by devices, No difference in the intraocular pressure measured by Accupen or Icare compared to Goldmann tonometer., at the post-operative visit (1 day after surgery)
Secondary Outcome Measures: Reliability and validity of devices at all intracular pressure level, The devices have the same intraocular pressure measured by Goldmann tonometer at High level of pressure (\>24mmHg), moderate level (10-24mmHg) and low level (\<10mmHg)., at the post-operative visit (1 day after surgery)
16SRDNA Sequencing of 30 Samples of Human Oral Microbial Samples by Tianjin Medical University
NCT Number: NCT06522841
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Oral Microbiome|Sampling Methods|Epidemiological Studies
Sponsor: Tianjin Medical University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Observational Model: |Time Perspective: p
Start Date: 2021-09-01
Completion Date: 2024-06-01
Locations: Tianjin Medical University School of Stomatology, Tianjin, Tianjin, 300070, China

Summary:
Study Objective:

To explore suitable sampling sites and methods for oral epidemiological surveys in large populations, we aim to compare the distribution of the oral core microbiome at different sites and using different sampling methods in a small sample of healthy individuals.

Main Question:

What is the distribution of the oral core microbiome at different sampling sites and using different sampling methods in orally healthy individuals?

Study Design:

Participants will be randomly selected from a population of orally healthy individuals. After explaining the study to the participants and obtaining informed consent, they will complete a consent form and be informed of the precautions. Samples will be collected using cotton swabs and curettes from the buccal surface of the lower right first molar and using cotton swabs from the left and right buccal mucosa. The samples will be placed in pre-numbered test tubes and sent to the laboratory for microbiome analysis.

Primary Outcome Measures: 16SRDNA sequencing of 30 samples of human oral microbial samples by Tianjin Medical University, Four sites were assessed: the buccal mucosa on both sides and the buccal surfaces of the left and right mandibular first molars. Two sampling methods, swab and curette, were used to collect bacterial communities from healthy individuals. Specifically, buccal mucosa samples (n=10) and tooth surface samples (n=20) were analyzed using 16S rDNA gene sequencing. Bacterial signals were detected through fluorescence in situ hybridization (FISH), targeting the bacterial 16S rDNA gene. Metastats analysis and Wilcoxon test were used., 2021.07 - 2021.12 Finalize research topic. 2021.12 - 2022.06 Complete bibliometric analysis. 2022.06 - 2022.12 Acquire data for analysis. 2022.12 - 2023.06 Obtain analysis results. 2023.06 - 2024.01 Complete and submit the thesis.
A Study to Evaluate SSGJ-707 in Advanced Gynecologic Cancer Patients
NCT Number: NCT06522828
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Advanced/Recurrent Endometrial Cancer and Platinum-resistant Ovarian Cancer
Interventions: DRUG: SSGJ-707|DRUG: carboplatin|DRUG: paclitaxel
Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2026-08
Locations: Zhou Qi, Chongqing, Chongqing, China

Summary:
This is an open, multicenter Phase II clinical study of SSGJ-707 combined with chemotherapy in the treatment of advanced/recurrent endometrial cancer and platinum-resistant ovarian cancer. The objective is to evaluate the safety, tolerability and antitumor activity of SSGJ-707 in the treatment of advanced/recurrent endometrial cancer and platinum-resistant ovarian cancer.

Primary Outcome Measures: ORR, Objective response rate, 12 months|Safety and tolerability, Safety and tolerability assessed by incidence and severity of adverse events, 12 months
Secondary Outcome Measures: PFS, The efficacy end point, 24 months
Updating Deep Learning Algorithms for OSA Monitoring
NCT Number: NCT06522815
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Obstructive Sleep Apnea|Obstructive Sleep Apnea-hypopnea
Interventions: DEVICE: CART-I plus|DEVICE: Polysomnography
Sponsor: Sky Labs
Collaborators: Gangnam Severance Hospital
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 107
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2022-10-19
Completion Date: 2025-07-11
Locations: Gangnam Severance Hospital, Seoul, Korea, Republic of

Summary:
The objective is to enhance the reliability of the algorithm to match that of Level 1 polysomnography by leveraging the diverse data obtained from Level 1 polysomnography to refine the deep learning algorithm.

Primary Outcome Measures: Accuracy of the algorithm and the 95% confidence interval, Present the accuracy of the algorithm and the 95% confidence interval. If the lower bound of the 95% confidence interval exceeds a minimum accuracy of 0.85, it is considered clinically significant., 11 hours
Secondary Outcome Measures: Accuracy and 95% confidence intervals for each interval, Present the accuracy and 95% confidence intervals for each interval. Additionally, precision, recall, ROC curve, and AUC may be presented. The performance comparison between algorithms will use the bootstrap method, and a p-value less than 0.05 will be considered statistically significant., 11 hours
The Effect of Wearing a Mask for Balance and Reaction Time
NCT Number: NCT06522802
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Reaction Time|Balance
Interventions: DIAGNOSTIC_TEST: balance tests, reaction time evaluation
Sponsor: Istanbul Medipol University Hospital
Sex: ALL
Age: ADULT
Enrollment: 25
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2020-12-08
Completion Date: 2022-01-10
Locations: Istanbul Medipol University, Istanbul, Beykoz, Turkey

Summary:
A mask is a protective equipment that covers the mouth and nose and is routinely used in workplaces, public transport and other communal settings preventing harmful particles, dust, droplets, bacteria, viruses, fog, gas, smoke and steam from entering the respiratory system. However, wearing a mask may impair the visual field, potentially affecting balance and reaction time. The investigators' aim is to determine whether the use of masks affects people's balance and reactions.

Primary Outcome Measures: Functional reach test, Functional Reach Test (FRT) is a clinical outcome measure and assessment tool for ascertaining dynamic balance in in simple task. As we know that this test measures the distance between the length of an outstretched arm in a maximal forward reach, while maintaining a fixed base of support., baseline-5 hours later
Secondary Outcome Measures: COP displacement, Displacement of the center of pressure (COP) and center of gravity (COG) a: COP ML displacement. Distance of the inflection point from a stationary baseline. b: Maximum ML separation. Maximum distance between the COP and COG. Source publication., baseline-5 hours later|BlazePod evaluation, A new technology (BlazePod™) that measures response time (RT) is currently on the market and has been used by strength and conditioning professionals., baseline-5 hours later
Preoperative Corneal Measurements Estimate the Corrected Distance Visual Acuity After Corneal Cross-linking
NCT Number: NCT06522789
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Keratoconus
Interventions: PROCEDURE: corneal cross-linking procedure
Sponsor: Sistina Ophthalmology Hospital
Sex: ALL
Age: CHILD, ADULT
Enrollment: 124
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2018-04-01
Completion Date: 2023-07-30
Locations: Fanka Gilevska, Skopje, 1000, North Macedonia

Summary:
This study aims to determine if objective markers describing corneal optical density (COD), thinnest corneal thickness (TCT), anterior (ARC), and posterior (PRC) surface radii over the 3mm thinnest region of the cornea could provide a model for calculating corrected distance visual acuity (CDVA) after corneal cross-linking (CXL) in keratoconus.

Primary Outcome Measures: Association between preoperative corneal characteristics derived by Pentacam and subjective parameter CDVA and postoperative CDVA at the end of the follow-up period, Associations between Corneal Optical Density, Thinnest Corneal Thickness, Anterior Radius Curvature (ARC), Posterior Radius Curvature (PRC), ARC/PRC ratio, CDVA values at the start of the study and CDVA at postoperative., one year|Associations between predicted and actual CDVA following CXL, The differences in the mean predicted values measured at six months and one year., one year
Secondary Outcome Measures: Corrected Distance Visual Acuity (CDVA) changes in all three groups during the follow up, Comparison of CDVA changes between the groups, one year|Corneal Optical Density (COD) changes in all three groups during the follow up, COD values for the central 0-2mm region covering the anterior (0-2ant) and central layers (0-2cent), paracentral 2-6mm annulus covering the anterior (2-6ant) and central layers (2-6cent), total anterior region layer (tot ant), total central layer (tot cent), and whole cornea (tot) were recorded. Separate COD values for the peripheral (6-10mm and 10-12mm annuli) and posterior (60µ) regions of the cornea were excluded as these regions were least likely to be affected by CXL., one year|Corneal thickness (TCT) changes in all three groups during the follow up., Comparison of TCT changes between the groups, one year
Remote Psychological Intervention for COVID-19 Survivors With AKI and Caregivers (REPICOV-AKI)
NCT Number: NCT06522776
Acronym: REPICOV-AKI
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: COVID-19|Anxiety|Depressive Symptoms|Acute Kidney Injury
Interventions: BEHAVIORAL: Cognitive behavioral therapy
Sponsor: Jesus Rivero, MD
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 98
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2021-03-01
Completion Date: 2024-07-01
Locations: National Institute of Respiratory Diseases, Mexico City, Ciudad DE México, 14080, Mexico

Summary:
The frequency of psychological conditions in recovered COVID-19 patients with Acute Kidney Injury (AKI) and their informal primary caregivers (IPC) is unknown; as well as the effects of psychological therapy in this population. The present study was initiated to determine the effectiveness of a brief remote psychological intervention (BRPI) to reduce anxious and depressive symptoms in survivors of AKI.

The investigator designed a single-case experimental design A-B with prospective follow-up. We used the Patient Health Questionnaire-9 (PHQ-9) and the General Anxiety Disorder Scale-7 (GAD-7) to screen for depressive and anxiety symptoms, one week later after hospital discharge. Those with moderate or severe symptoms received cognitive behavioral therapy (CBT) and were evaluated over time with the instruments and daily self-report of symptoms. The statistical analysis was conducted using statistical software.

Primary Outcome Measures: Anxious symptoms score for identifying changes in psychological behavior before and after to brief remote psychological intervention., Psychological behavior changes were evaluated by the anxious symptoms score (mild, moderate, and severe) using General Anxiety Disorder Scale-7 (GAD-7)., From the date of one week later after hospital discharge at the hospital until the date of the end intervention, in average one month|Depressive symptoms score for identifying changes in psychological behavior before and after to brief remote psychological intervention., Psychological behavior changes were evaluated by the depressive symptoms score (mild, moderate, and severe) using the Patient Health Questionnaire-9 (PHQ-9)., From the date of one week later after hospital discharge at the hospital until the date of the end intervention, in average one month
Secondary Outcome Measures: General perception scale for identifying the utility of each technique used for the management of psychological symptoms., The utility of each technique used for the management of psychological symptoms was evaluated by the general perception scale using a short questionnaire with daily self-record of symptoms perception (0-10 scale)., From the date of one week later after hospital discharge at the hospital until the date of the end intervention, in average one month
Bioequivalence Study of Sulfadoxine/Pyrimethamine 500/25 mg Dispersible Tablet
NCT Number: NCT06522763
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Fasting
Interventions: DRUG: Sulfadoxine 500 MG / Pyrimethamine 25 MG dispersible tablets.|DRUG: Sulfadoxine 500 MG / Pyrimethamine 25 MG dispersible tablets in SPAQ
Sponsor: Swiss Pharma Nigeria Limited
Collaborators: Medicines for Malaria Venture
Sex: ALL
Age: ADULT
Enrollment: 46
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07
Completion Date: 2024-09
Locations: International Pharmaceutical Research Center (IPRC) Queen Rania Street - Sport City Circle,, Amman, 11196, Jordan

Summary:
The primary objective of this study is to assess the bioequivalence between the test product and the reference product based on Cmax and AUC0-\>72 for sulfadoxine and pyrimethamine in healthy adults under fasting conditions. The secondary objectives of present study are to describe the Tmax and assess the safety and tolerability profile of both test and reference products.

Primary Outcome Measures: Maximal Plasma Concentration (Cmax)., The confidence intervals of logarithmically transformed Test/Reference ratios for Cmax are set to be within 80.00-125.00% for sulfadoxine and pyrimethamine. ANOVA using 5 % significance level on logarithmically transformed data (with the 90% confidence intervals) of Cmax and AUC0-72 for sulfadoxine and pyrimethamine using WinNonLin statistical software version 8.4 or higher., 72 hours|Area Under the plasma concentration-time Curve (AUC)., The confidence intervals of logarithmically transformed Test/Reference ratios for AUC are set to be within 80.00-125.00% for sulfadoxine and pyrimethamine. ANOVA using 5 % significance level on logarithmically transformed data (with the 90% confidence intervals) of AUC0-72 for sulfadoxine and pyrimethamine using WinNonLin statistical software version 8.4 or higher., 72 hours
Secondary Outcome Measures: Time point of maximal plasma concentration (Tmax), Time of the maximum measured plasma concentration. If the maximum value occurs at more than one time point, Tmax is defined as the first time point with this value., To be determined within the 72 hours range
A Study of Duvelisib Versus Gemcitabine or Bendamustine in Participants With Relapsed/Refractory Nodal T Cell Lymphoma With T Follicular Helper (TFH) Phenotype
NCT Number: NCT06522737
Acronym: TERZO
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Lymphoma
Interventions: DRUG: Duvelisib|DRUG: Gemcitabine|DRUG: Bendamustine
Sponsor: SecuraBio
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 124
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-12
Completion Date: 2028-12

Summary:
The study will evaluate the progression-free survival benefit of duvelisib monotherapy as compared to investigator's choice of gemcitabine or bendamustine in participants with relapsed/refractory nodal T cell lymphoma with TFH phenotype.

Primary Outcome Measures: Progression-free Survival (PFS) as assessed by the Independent Review Committee (IRC), Up to 3 years
Secondary Outcome Measures: Overall Survival (OS), Up to 3 years|PFS as assessed by the investigator, Up to 3 years|Objective Response Rate (ORR) as assessed by the IRC, Up to 3 years|Complete Response Rate (CRR) as assessed by the IRC, Up to 3 years|Duration of Response (DOR) as assessed by the IRC, Up to 3 years|Proportion of participants who proceed to Stem Cell Transplantation (SCT), Up to 3 years|Investigator-assessed PFS in participants who proceed to SCT, Up to 3 years|Number of participants with Adverse Events (AEs), Up to 3 years|Quality of Life (QoL): European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 Score, Up to 3 years|QoL: EQ5D Score, Up to 3 years|QoL: QLQ-NHL-HG29 Score, Up to 3 years
A Study To Assess The Effect Of My Happy Flo On Alleviating Period Symptoms and Heavy Flows.
NCT Number: NCT06522672
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Menstrual Cramps|Women's Health|Fatigue
Interventions: DIETARY_SUPPLEMENT: My Happy Flo
Sponsor: My Happy Flo
Collaborators: Citruslabs
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-05-31
Completion Date: 2024-08-31
Locations: Citruslabs, Santa Monica, California, 90404, United States

Summary:
This clinical study aims to evaluate the effectiveness of My Happy Flo, a dietary supplement, in alleviating period symptoms and heavy menstrual flows. The study involves 40 participants, who will take the supplement daily for three menstrual cycles. Primary outcomes, such as the severity of heavy flows, prolonged periods, cramps, mood, energy levels, cycle regulation, and fatigue, will be measured using validated questionnaires completed after each menstrual cycle. Secondary outcomes, including Vitamin D and Iron levels, will be assessed through blood tests at the beginning and end of the study period.

Primary Outcome Measures: Improvement in Period Symptoms, Measurement of heavy flows, prolonged periods, cramps, mood disturbances, energy levels, cycle regulation, and fatigue using validated questionnaires., Baseline (Day 0), Cycle 1, Cycle 2, and Cycle 3 - each Cycle is 28 days
Secondary Outcome Measures: Changes in Vitamin D Level, Assessment of Vitamin D level through blood tests., Baseline and Cycle 3 - each Cycle is 28 days|Changes in Iron Level, Assessment of Iron level through blood tests., Baseline and Cycle 3 - each Cycle is 28 days
Effect of Posterior Femoral Cutaneous Nerve Block on Postoperative Posterior Lateral Knee Analgesia in Patients With TKA
NCT Number: NCT06522620
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Postoperative Pain
Interventions: PROCEDURE: Posterior Femoral Cutaneous Nerve Combined With Proximal Sciatic and Saphenous Nerve Block|PROCEDURE: Simple Sciatic and Saphenous Nerve Blocks
Sponsor: General Hospital of Ningxia Medical University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 90
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-04-25
Completion Date: 2024-08-25
Locations: General hospital of Ningxia medical university, Yinchuan, Ningxia, 750004, China

Summary:
The aim of this study was to observe the effects of posterior femoral cutaneous nerve block combined with sciatic and saphenous nerve block compared with sciatic and saphenous nerve block alone on postoperative posterior side of the knee (popliteal fossa) pain and sleep quality in patients with TKA, and to further alleviate postoperative posterior side of the knee pain in patients with TKA and improve the quality of postoperative sleep.

Primary Outcome Measures: Postoperative anteroposterior and posterior knee Visual Analogue Scale scores (passive motion/resting), The level of pain at the knee surface incision and on the posterior side of the knee at rest and motion was asked and recorded using the Visual Analogue Scale scores at postoperative hour 1 (before the patient left the PACU), postoperative hour 6, postoperative hour 24, and postoperative hour 48, respectively (0 for no pain and 10 for the most severe pain imaginable), postoperative hour 1，postoperative hour 6，postoperative hour 24，postoperative hour 48
Secondary Outcome Measures: Postoperative night sleep time, Use of exercise bracelets to record actual hours of patient sleep, First night after surgery, second night after surgery|Earliest time on the ground, Length of time between the end of surgery and the patient's active movement off the floor, Within 48 hours of surgery|Amount of remedial opioid use, Total remedially applied opioids within 48 hours of surgery, Within 48 hours of surgery|Number of patient PCNA uses, Number of times a patient presses the PCNA in the 48 hours postoperatively, Within 48 hours of surgery|Incidence rate of postoperative adverse outcomes, Including （1）the number of people who experienced soreness in the affected limb, （2）the number of people who had nausea and the number of times they vomited,（3） the number of people who had the femoral nerve recanalized, （4）the number of people who had thrombosis in the first 48 hours after the operation, （5）and the number of people who had urinary retention., Within 48 hours of surgery|Hip Knee Ankle, Comparison of the change in HKA angle on lower extremity X-ray film in patients during the preoperative week versus the change in HKA angle on lower extremity X-ray film during the postoperative week, within the preoperative week versus the postoperative week
Role of Citicoline in Treatment of Neonates With Hypoxic Ischemic Encephalopathy
NCT Number: NCT06522581
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Hypoxic Ischemic Encephalopathy of Newborn
Interventions: DRUG: Citicoline Sodium
Sponsor: Armed Forces Hospital, Pakistan
Sex: ALL
Age: CHILD
Enrollment: 200
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-01-01
Completion Date: 2025-01-01
Locations: MH, Rawalpindi, 68000, Pakistan

Summary:
Hypoxic ischemic encephalopathy is an acute or subacute brain injury, due to asphyxia in neonates, leading to mortality and long-term morbidity. Its prevalence varies across regions, with developed countries reporting rates of 1.5 per 1000 live births, while developing nations experience a wider range from 2.3 to 26.5 per 1000 live births.

Infants afflicted with moderate HIE face a 10% risk of mortality, with surviving individuals encountering a 30% chance of developing disabilities. The prognosis is graver for severe HIE, with a mortality risk of 60%, and nearly all survivors experiencing some form of disability.

Primary Outcome Measures: survival in newborn babies with HIE, we will be evaluationg the efficacy of citicoline in newborns with HIE, one year after the start of study
Testing a Mammography Decision Intervention in a Rural Setting
NCT Number: NCT06522568
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Breast Cancer
Interventions: BEHAVIORAL: MyMammogram|OTHER: Provider communication
Sponsor: Dartmouth-Hitchcock Medical Center
Collaborators: Trustees of Dartmouth College
Sex: FEMALE
Age: ADULT
Enrollment: 39
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2025-05
Completion Date: 2025-12

Summary:
The overall objective of this COBRE pilot project is to enhance the design of a 3-arm cluster randomized trial that will test the efficacy and mechanism of effect of the MyMammogram DA with or without a provider communication intervention. This will be accomplished through two aims: (1) Refine, with community partner input, a clinical trial protocol to optimize engagement among patients and primary care providers (PCPs) practicing in rural settings. In consultation with patients, PCPs, and informatics experts, the study team will refine site selection, randomization, patient and PCP recruitment, and data collection protocols to meet the needs of the rural health care delivery system and participants. The result of this aim will be a modified protocol and intervention strategy that is acceptable to partners. (2) Adapt and test trial and intervention implementation features to achieve protocol acceptance and adherence. The investigators will pilot the adapted three-arm randomized trial protocol in rural primary care settings that compares the MyMammogram DA with or without a risk summary provided to the PCP pre-visit, relative to usual care. Implementing the trial in two phases (n=15 each) will systematically identify barriers and facilitators to trial participation to refine protocols. Participants will receive acceptability surveys and investigators will conduct qualitative interviews with patients and PCPs to understand experiences with trial implementation from multiple perspectives.

Primary Outcome Measures: Acceptability e-scale, The acceptability e-scale is a 6-item measure for electronically-delivered interventions, where higher scores indicate greater acceptability. Scores range from 6-30., Within 1 day, post-intervention
Gastric Cancer Complicated With Bleeding
NCT Number: NCT06522542
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Gastric Cancer
Interventions: DRUG: systematic therapy
Sponsor: Peking University Third Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-01
Completion Date: 2026-07-31

Summary:
To investigate the impact of bleeding on the survival and treatment-related adverse events (TRAEs) of gastric cancer patients.

Primary Outcome Measures: Overall survival (OS), OS was defined as the time from the first cycle of systematic therapy to death from any cause., from date of the first cycle of systematic therapy to death from any cause，assessed up to 120 months