pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Evaluation of Access to Screening for Post-partum Depression Via the Postnatal Interview Within 8 Weeks of Birth in Women Who Have Gave Birth at the Troyes Hospital ( DEPRESSIONPP )
NCT Number: NCT06469476
Acronym: DEPRESSIONPP
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Depression, Postpartum
Interventions: BEHAVIORAL: depression post partum
Sponsor: Centre Hospitalier de Troyes
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 400
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-03-01
Completion Date: 2024-08-31
Locations: Centre Hospitalier de Troyes, Troyes, Grand-Est, 10000, France

Summary:
Post-partum depression is defined as a depressive disorder with onset of symptoms in the year following childbirth. Several international studies have reported a prevalence of this condition of around pathology of around 15%. Santé publique France's 2021 national perinatal survey corroborated these figures, finding a prevalence of post-partum depression in France of in France of 16.7%. It is therefore a frequent pathology that can cause complications for both mother and child.

The complications both for the mother and for the mother-child bond. Indeed, post-partum depression can lead to an increased risk of infanticide, weaker mother-child attachment, and altered parental behaviour. post-partum depression can lead to maternal suicide (the second leading cause cause of maternal mortality in France). Despite the potential seriousness of severe depression and its impact on the on the mother-child bond, just under half of those suffering from severe depression suffering from severe depression consult a healthcare professional.

Fear of being judged or stigmatised, linked to misperceptions about the episode, is one of the main obstacles to consultation.

Of being judged or stigmatised, linked to erroneous representations of the depressive episode. Given the scale of this condition, and the difficulties young mothers face in seeking help for young mothers to seek help, it is vital to screen postpartum women as widely and post-partum women as early as possible. In view of the extent of this condition and the difficulties young mothers have in seeking help for young mothers, it is vital to screen post-partum women as widely and as post-partum. With this in mind, from July 2022, a compulsory early post-natal interview has been introduced, designed to screen for postpartum depression.

Primary Outcome Measures: Measure if the patient is yes or not to be referred by a healthcare professional during the early postnatal interview., question, 3 months
Secondary Outcome Measures: Measure the socio-economic status, financial parameter, 3 months|measure the declaration of a financial or non-financial obstacle, financial parameter, 3 months|measure the knowledge about post-partum depression, question first contact, 3 months|measure the knowledge about early post-natal interview., question, 3 months
KF2023#1-Trial: Influence of Statin Intake on Cellular Readouts
NCT Number: NCT06469450
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Pharmacodynamics
Interventions: DRUG: Atorvastatin
Sponsor: Mikko Niemi
Collaborators: University of Helsinki
Sex: ALL
Age: ADULT
Enrollment: 15
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-04-20
Completion Date: 2024-12-31
Locations: Department of Clinical Pharmacology, Helsinki, 00290, Finland

Summary:
A majority of high-risk patients does not achieve their cholesterol target levels and most of these patients do not receive more effective combination therapy, which goes beyond statin monotherapy. Large interindividual differences in treatment outcomes have been observed for patients receiving statins. Statins block cholesterol synthesis and increase cellular low-density lipoprotein (LDL) uptake. Importantly, LDL uptake is highly divergent in individuals.The aim of this trial is to investigate how atorvastatin influences leukocyte readouts of LDL uptake and lipid storage in humans. The trial is a single-arm, open-label, interventional trial. A total of 15 healthy volunteers will receive 40 mg atorvastatin once a day for 4 weeks. The participants will provide blood samples before starting the atorvastatin intervention, each week when taking atorvastatin, and one week after the end of the intervention for the measurement of leukocyte readouts of LDL uptake and lipid storage.

Primary Outcome Measures: Lipid trafficking score LT-Mo, The primary outcome measurement is the "lipid trafficking score LT-Mo" is a combination of LDL uptake and lipid droplet quantifications in monocytes.

The participants provide blood samples before starting the atorvastatin intervention, each week when taking atorvastatin (4 times in total), and one week after the end of the intervention., Baseline and once a week for 5 weeks
Secondary Outcome Measures: Leukocyte LDL uptake, Systematic quantification of leukocyte uptake of low-density lipoprotein (LDL). Leukocytes are exposed to fluorescently labelled LDL particles and internalized LDL particles are quantified with microscopy and automated image analysis. The specific readouts are overall fluorescent LDL intensity and the number of endosomal organelles filled with fluorescent LDL particles for monocyte and lymphocyte subpopulations., Baseline and once a week for 5 weeks|Leukocyte lipid storage, A systematic semi-automated approach is used to quantify cellular lipid droplets, dedicated storage organelles for lipids. Individual lipid droplets, their size and area are quantified in each cell and either used as individual readouts or combined with LDL uptake readouts to derive lipid trafficking scores., Baseline and once a week for 5 weeks|Atorvastatin plasma concentration, The plasma concentrations of atorvastatin and its metabolites will be quantified with liquid chromatography tandem mass spectrometry (LC-MS/MS) from plasma samples., Once a week during the 4 week atorvastatin treatment
Effect of PMSCs and Their Secretome for the Treatment of GvHD
NCT Number: NCT06469411
Acronym: GvHD
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: GVHD
Interventions: BIOLOGICAL: Secretome (set of substances released from the cell to its surroundings) of mesenchymal stem cells retrieved from the placenta (containing 400 microgram protein/ milliliter)|OTHER: 4 cc distilled water dissolved in albumin 20%
Sponsor: Tabriz University of Medical Sciences
Collaborators: SCARM Institute, Tabriz, Iran
Sex: ALL
Age: CHILD, ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2023-01-01
Completion Date: 2024-01-30
Locations: Abolfazl Barzegari, Tabriz, East Azerbaijan, 5166614756, Iran, Islamic Republic of

Summary:
In this clinical trial study, 60 patients with GvHD referred to Shahid Qazi Hospital in Tabriz, were randomly divided into 2 intervention and control groups (n= 30 in each) that received secretome and distilled water by injection, respectively. The method of blinding was triple-blinded and all the names and personal information of the patients were coded at the time of data collection and remained completely confidential.

Primary Outcome Measures: Liver involvement, Measurement of Bilirubin level, At the beginning of the study and 6 weeks after the intervention|Intestine condition, Diarrhea volume measurement, At the beginning of the study and 6 weeks after the intervention|Skin rash, Determination of BSA percentage, At the beginning of the study and 6 weeks after the intervention
A Post Market Device Study for the Treatment of Acne
NCT Number: NCT06469398
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Acne Vulgaris
Interventions: DEVICE: Cutera Laser System
Sponsor: Cutera Inc.
Sex: ALL
Age: CHILD, ADULT
Enrollment: 50
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2022-07-21
Completion Date: 2025-08-18
Locations: Dermatology of Boca, Boca Raton, Florida, 33431, United States|Schweiger Dermatology PC, Reseach Division, Hackensack, New Jersey, 07601, United States|Bellaire Dermatology Associates, Bellaire, Texas, 77401, United States

Summary:
To evaluate the safety and efficacy of the Cutera laser system for the treatment of acne vulgaris.

Primary Outcome Measures: Percent of Subjects Who are Responders, The primary outcome measure to evaluate the efficacy of the Cutera device is the percent of subjects who are responders at 12 weeks post final treatment, where a responder is defined as ≥ 1-point reduction on the Investigator's Global Assessment scale at follow up compared to baseline., 12 weeks post final treatment
Cardiac Amyloidosis Discovery Trial
NCT Number: NCT06469372
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cardiac Amyloidosis
Interventions: DEVICE: Cardiac amyloidosis deep learning model
Sponsor: Timothy Poterucha
Collaborators: Pfizer|American Heart Association|Eidos Therapeutics, a BridgeBio company
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-05-28
Completion Date: 2025-12
Locations: Columbia University Irving Medical Center / NewYork-Presbyterian Hospital, New York, New York, 10032, United States

Summary:
This is a single center, diagnostic clinical trial in which the investigators aim to prospectively validate a deep learning model that identifies patients with features suggestive of cardiac amyloidosis, including transthyretin cardiac amyloidosis (ATTR-CA).

Cardiac Amyloidosis is an age-related infiltrative cardiomyopathy that causes heart failure and death that is frequently unrecognized and underdiagnosed. The investigators have developed a deep learning model that identifies patients with features of ATTR-CA and other types of cardiac amyloidosis using echocardiographic, ECG, and clinical factors. By applying this model to the population served by NewYork-Presbyterian Hospital, the investigators will identify a list of patients at highest predicted risk for having undiagnosed cardiac amyloidosis. The investigators will then invite these patients for further testing to diagnose cardiac amyloidosis. The rate of cardiac amyloidosis diagnosis of patients in this study will be compared to rate of cardiac amyloidosis diagnosis in historic controls from the following two groups: (1) patients referred for clinical cardiac amyloidosis testing at NewYork-Prebysterian Hospital and (2) patients enrolled in the Screening for Cardiac Amyloidosis With Nuclear Imaging in Minority Populations (SCAN-MP) study.

Primary Outcome Measures: Rate of Cardiac Amyloidosis Diagnosis, The primary outcome is the rate of cardiac amyloidosis diagnosis (inclusive of transthyretin and light chain cardiac amyloidosis) which is performed in response to patient identification using the deep learning model., Up to 1 year after identification
Analyzes of Nasal Tissue-resident Memory Immune Cells and Peripheral Memory Cells Able to Migrate to Airway Tissues (MUCOVAC)
NCT Number: NCT06469359
Acronym: MUCOVAC
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Healthy Volunteers
Interventions: DEVICE: Nasal tissue-resident memory T and B cells|DEVICE: Nasal fluid sampling|DEVICE: Saliva sampling|OTHER: Blood sampling|DIAGNOSTIC_TEST: ELISA|DIAGNOSTIC_TEST: Neutralization test|DIAGNOSTIC_TEST: ELISPot|DIAGNOSTIC_TEST: Transcriptomics
Sponsor: Centre Hospitalier Universitaire de Saint Etienne
Collaborators: Sanofi Pasteur, a Sanofi Company
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: SINGLE (PARTICIPANT)|Primary Purpose: DIAGNOSTIC
Start Date: 2024-07-22
Completion Date: 2025-03-01
Locations: Centre Hospitalier Universitaire, Saint-Étienne, 42055, France

Summary:
Clinical evaluation of vaccines against respiratory viruses is currently based on the analysis of systemic immune responses, whereas respiratory immunity is the first line of defense against respiratory pathogens. In addition to secretory immunoglobulin A (IgA) in mucosal fluids which are essential to neutralize the pathogens at mucosal surfaces, tissue-resident memory immune cells have been shown to be crucial in protection. Furthermore, memory immune cells in blood able to migrate to airway tissues also play a crucial role. Airway immune responses have not been studied a lot due to the lack of a standardized methodology to evaluate them in humans.

Primary Outcome Measures: Frequency of resident memory lymphocytes in the nasal mucosa measured by FLOQSwab, This outcome is measured by the three devices :

* FLOQSwab
* Rhino-Pro Curette
* Cervical brush, At inclusion, one month, two months
Secondary Outcome Measures: Frequencies of resident memory T and B lymphocytes, Frequencies of resident memory T and B lymphocytes are measured by the three devices :

* FLOQSwab
* Rhino-Pro Curette
* Cervical brush, At inclusion, one month, two months|Expression levels of respiratory mucosal migration markers on peripheral memory lymphocytes, This outcome is measured by the three devices :

* FLOQSwab
* Rhino-Pro Curette
* Cervical brush, At inclusion, one month, two months|Visual analog scale for pain, Scale from 0 to 10 (0 = no pain, 10 = intolerable pain)

This outcome is measured by the three devices :

* FLOQSwab
* Rhino-Pro Curette
* Cervical brush, At inclusion, one month, two months
Comparison of Eccentric Exercise and Static Stretching on Muscle Flexibility
NCT Number: NCT06469346
Acronym: COEESS
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Muscle Stretching Exercise|Range of Motion, Articular
Interventions: OTHER: Nordic Hamstring Eccentric Exercise Training|OTHER: Passive Hamstring Static Stretching Training|OTHER: Control Group
Sponsor: Universidad de La Frontera
Sex: MALE
Age: ADULT
Enrollment: 42
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-05
Completion Date: 2025-03-28

Summary:
Background: Muscle flexibility is a fundamental physical quality for body development, daily life and sports activities, and also for maintaining muscle quality during aging. Limited flexibility leads to an increased prevalence of musculoskeletal injury in general population and longer return to sports activities.

Among the existent strategies to increase muscle flexibility in sports training and physical rehabilitation, static stretching is commonly used by health and physical activity professionals. Its effectiveness in increasing flexibility has been widely demonstrated; however its effects on muscle strength and power remains controversial.

Therefore, eccentric resistance exercise has been proposed as an effective intervention for increasing muscle flexibility through structural changes on muscle architecture (pennation angle and fascicle length) with the additional benefit of resistance training on muscle strength and power. Nonetheless, its unknown if the increase in muscle flexibility through eccentric resistance exercise could be similar to what has been previously demonstrated with static stretching.

Primary Outcome Measures: Knee Extension Angle, The degree changes in passive knee extension will be assessed using Passive Knee Extension Angle Test after intervention, Before and after 6 weeks of training|Sit-and-Reach, The distance (in centimeters) of change on functional posterior chain flexibility will be obtained in Sit-and-Reach Test after intervention, Before and after 6 weeks of training
Secondary Outcome Measures: Maximal Isometric Voluntary Strength, Change in unilateral isometric hamstring strength will be evaluated with load cell force transducer after intervention, Before and after 6 weeks of training|Long Head Biceps Femoris Pennation Angle, Change in pennation angle will be measured using muscular ultrasound after intervention, Before and after 6 weeks of training|Long Head Biceps Femoris Fascicle Length, Change in fascicle length will be measured using muscular ultrasound after intervention, Before and after 6 weeks of training|Long Head Biceps Femoris Muscle Thickness, Change in muscle thickness will be measured using muscular ultrasound after intervention, Before and after 6 weeks of training
Urinary Incontinence and Other Pelvic Floor Dysfunctions in Trail Runners
NCT Number: NCT06469320
Acronym: IU-TRAIL
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Urinary Stress Incontinence
Interventions: OTHER: Online questionnaire
Sponsor: Centre Hospitalier Universitaire de la Réunion
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 1500
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-25
Completion Date: 2025-01
Locations: CHU la Réunion, Saint-Denis, 97400, Réunion

Summary:
The pelvic floor is a crucial complex for many bodily functions, supporting the pelvic organs and contributing to urinary and anal continence, as well as sexual function. Dysfunction of this structure can lead to a variety of disorders, including urinary incontinence (UI), a common problem in women. Although the prevalence of UI in middle-aged women has been documented at between 20% and 30%, high-impact physical activities, such as certain sports and running, increase the risk of UI. According to the most recently published meta-analysis, the prevalence is 44% \[95%CI 30.2-57.8\]. Although this subject is often taboo, it can have psychosocial consequences and affect sporting activities. Only 31.7% of female runners talk to a health professional about it. Trail running, a fast-growing discipline, differs from road running in its particular physical demands, which could influence the occurrence of pelvic floor disorders (PFD) and exercise-induced UTIs. The unique characteristics of trail running, such as the technical nature of the terrain, the steep gradients and the variety of distances, place intense demands on the female pelvi-perineal system. Nevertheless, despite the growing popularity of this sport, little epidemiological data exists on the prevalence of stress UTI and pelvic floor disorders among female trail runners.

Primary Outcome Measures: Prevalence of stress urinary incontinence (SUI) and pelvic floor dysfunction (PFD), The prevalence will be determined by determining the proportion of female trail runners reporting Stress urinary incontinence and/or Pelvic floor muscle dysfunction out of the total population of trail runners who responded to the questionnaire., 6 months
Secondary Outcome Measures: Identify the risk factors associated with SUI and PFD in French trail runners., Identification of the relative risks of the various suspected risk factors using a multiple logistic regression model, 6 months|To assess the impact of SUI and PFD on the sporting activities and daily lives of French trail runners, The various repercussions listed in the questionnaires will be presented in terms of the percentage of women affected and their 95% confidence interval. The averages of the visual analog scale associated with their parameters of dispersion in order to evaluate the impact of SUI on everyday life and in their sporting activities will also be presented., 6 months
Driving Inclusivity, Validity, and Equity in Research Through Strategic Engagement (DIVERSE)
NCT Number: NCT06469307
Acronym: DIVERSE
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Blood Cancer|Leukemia
Interventions: OTHER: DIVERSE Review Process
Sponsor: Dana-Farber Cancer Institute
Collaborators: National Cancer Institute (NCI)|American Society of Clinical Oncology
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-11
Completion Date: 2028-01-01
Locations: Dana-Farber Cancer Institute, Boston, Massachusetts, 02215, United States

Summary:
The purpose of this research study is to enhance inclusion and diversity in clinical trial enrollment by training participants to perform and provide feedback through a community-based protocol review process, called DIVERSE.

Primary Outcome Measures: Protocol Review Completion Rate, Feasibility is defined as the proportion of eligible protocols that have completed the DIVERSE review process. The target is a review completion of ≥ 60% of eligible protocols., 18 months|Protocol Review Completion Rate Within 35 Days, Feasibility is defined as the proportion of protocols that have completed the DIVERSE review process within 35 days of request. The goal is to have ≥ to 70% of reviews completed within 35 days., 18 months|Proportion of Acceptability of Intervention Measure (AIM) Scores of 10 or Greater, Acceptability is defined as the proportion of AIM scores provided by investigators after protocols have been assessed by the DIVERSE review process with ≥ 60% of AIM scores resulting as ≥10 on a scale of 0 - 20, where scores of 10 or above are considered "acceptable" or greater. The AIM is a 4-item, 5-point Likert scale-based measure., 18 months
A Study to Learn if 27T51, a Mucin-16 (MUC16) Protein Targeting Immune Cell Therapy, Administered Alone or in Combination is Safe and How Well it Works for Adult Participants With Recurrent or Treatment Resistant Ovarian Cancers
NCT Number: NCT06469281
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Epithelial Ovarian Cancer|Primary Peritoneal Carcinoma|Fallopian Tube Cancer
Interventions: OTHER: 27T51|DRUG: Cemiplimab|DRUG: Bevacizumab
Sponsor: Regeneron Pharmaceuticals
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 90
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-18
Completion Date: 2029-06-29
Locations: John Theurer Cancer Center Hackensack University Medical Center, Hackensack, New Jersey, 07601, United States

Summary:
This study is researching an experimental CAR T cell therapy called 27T51, referred to as study drug. The study drug is a MUC16 targeting immune cell therapy focused on adult female participants with recurrent or difficult to treat epithelial ovarian, primary peritoneal or fallopian tube cancer.

This study has two (2) major parts:

Phase 1a Dose Escalation and Phase 1b Dose Expansion. The aim of the dose escalation part will be to test the safety of 27T51 in a small number of participants to find the highest dose given to humans without unacceptable side effects. The aim of the dose expansion part will be to test 27T51 at the established dose level(s) from the dose escalation part and may include other medications given in combination with 27T51.

Information collected from this study will help researchers understand more fully whether this immune cell therapy, also known as CAR T cell therapy, can be safely used to treat solid tumors such as ovarian cancer.

Primary Outcome Measures: Incidence of treatment emergent adverse events (TEAEs), Part 1a, Up to 18 months|Incidence of adverse events of special interest (AESIs), Part 1a, Up to 18 months|Incidence of adverse events of dose limiting toxicities (DLTs), Part 1a, Up to 18 months|Manufacturing feasibility of 27T51, Phase 1a/1b Determination of the feasibility of manufacturing 27T51 is measured by the percent of leukapheresis products collected that are able to be manufactured and released for infusion., Up to 3 years|Overall response rate (ORR) as assessed by the investigator, Phase 1b, Up to 48 months
Secondary Outcome Measures: ORR as assessed by the investigator, Phase 1a, Up to 48 months|Duration of response (DoR), Phase 1a/1b, Up to 48 months|Disease control rate (DCR), Phase 1a/1b, Up to 48 months|Incidence of TEAEs, Phase 1b, Up to 48 months|Incidence of AESIs, Phase 1b, Up to 48 months|Incidence of DLTs, Phase 1b - Arms B and C, Up to 48 months
Clinical Performance of Two Frequent Replacement Silicone Hydrogel Multifocal Contact Lenses
NCT Number: NCT06469242
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Presbyopia
Interventions: DEVICE: Serafilcon A multifocal contact lenses|DEVICE: Senofilcon A multifocal contact lenses|DEVICE: CLEAR CARE® Cleaning & Disinfecting Solution
Sponsor: Alcon Research
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 96
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-18
Completion Date: 2024-10
Locations: Kurata Eyecare Center, Los Angeles, California, 90013, United States|Elsa Pao, OD, Oakland, California, 94607, United States|Drs. Giedd, P.A., Maitland, Florida, 32751, United States|Vision Health Institute, Orlando, Florida, 32803, United States|Wesley Optometric Consulting, Medina, Minnesota, 55340, United States|ProCare Vision Centers, Inc., Granville, Ohio, 43023, United States|Insight Research Clinic LLC, Powell, Ohio, 43065, United States|Optometry Group, PLLC, Memphis, Tennessee, 38111, United States

Summary:
The purpose of this study is to evaluate the on-eye multifocal clinical performance of investigational LID233309 contact lenses and Oasys multifocal (MF) contact lenses in a daily wear dispensing trial.

Primary Outcome Measures: Binocular visual acuity at distance (4 meters) at Week 1, Visual Acuity (VA) will be assessed at a distance of 4 meters for both eyes together under high contrast, high illumination lighting with study lenses in place. VA will be measured using letter charts and recorded in logarithm minimum angle of resolution (logMAR), with a logMAR value of 0 equating to 20/20 Snellen VA (normal distance eyesight) and lower logMAR values representing better eyesight., Week 1 (Day 7 -0/+1 days) of each wear period. A wear period is 14 days (-0/+2 days) according to randomization assignment.
Efficacy of Hyaluronic Acid in Prevention of Acute Radiation Proctitis
NCT Number: NCT06469216
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Acute Radiation Proctitis|Acute Radiation Enteritis
Interventions: DRUG: Hyaluronic Acid|OTHER: Placebo
Sponsor: Assiut University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 42
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-04-01
Completion Date: 2025-10
Locations: Al-Ahrar teaching hospital, Zagazig, Sharqia, 055, Egypt|Ahmed Maher teaching hospitals, Cairo, 055, Egypt

Summary:
A randomized placebo-controlled clinical trial to evaluate efficacy of hyaluronic acid in prevention of acute radiation proctitis among oncology patient population especially who are diagnosed with abdomeno-pelvic tumors and subsequently required radiotherapy.

Primary Outcome Measures: Time (in days) to occurrence of Acute Radiation Proctitis, for each patient: time from the first day of radiation therapy for up to 3 months
Oxytocin Effectiveness in First Trimester Dilatation and Curettage
NCT Number: NCT06469203
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Missed Abortion
Interventions: DRUG: Oxytocin|DRUG: Sodium Chloride 0.9% Inj
Sponsor: Assuta Ashdod Hospital
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 160
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-09-01
Completion Date: 2026-06

Summary:
The aim of this study is to investigate the impact of oxytocin on perioperative blood loss during the D\&C procedure, as well as to assess early and late complications associated with it's use.

Primary Outcome Measures: Perioperative Blood Loss Assessment, We will assess perioperative blood loss by:

* Measuring the content collected in the vacuum apparatus after the procedure.
* Recording hemoglobin and hematocrit levels prior to the procedure.
* Measuring hemoglobin and hematocrit levels immediately after the procedure.
* Monitoring hemoglobin and hematocrit levels two weeks post-procedure., 14 days
Secondary Outcome Measures: perioperative complications according to the Dindo-Clavien scale, perioperative complications according to the Dindo-Clavien scale, 30 days
An Exploratory Clinical Study of Anti-CD19 CAR NK Cell (KN5501) in the Treatment of Relapsed/Refractory Immune Nephropathy
NCT Number: NCT06469190
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: EARLY_PHASE1
Conditions: Nephropathy
Interventions: DRUG: KN5501
Sponsor: Changhai Hospital
Collaborators: Rui Therapeutics Co., Ltd
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 36
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-21
Completion Date: 2026-06-20
Locations: Shanghai Changhai hospital, Shanghai, China

Summary:
A single arm, open-label pilot study is designed to determine the safety and effectiveness of anti-CD19 CAR NK cell injection (KN5501) in patients with immune nephropathy. 36 patients are planned to be enrolled in the dose-escalation trial. The primary endpoints are DLT and TEAEs. The secondary endpoints are the overall response rates (ORR) and disease control rate (DCR)

Primary Outcome Measures: Incidence of Dose-Limiting Toxicity (DLT), To characterize the safety of Anti-CD19 CAR NK Cells (KN5501) for Relapsed/Refractory Immune Nephropathy, up to 48 weeks after infusion|Incidence of Treatment Emergent Adverse Events (TEAEs), To characterize the safety of Anti-CD19 CAR NK Cells (KN5501) for Relapsed/Refractory Immune Nephropathy, up to 48 weeks after infusion
Secondary Outcome Measures: The overall response rate (ORR), To characterize the efficacy of Anti-CD19 CAR NK Cell Therapy for Relapsed/Refractory Immune Nephropathy, 1, 3, 6, 12 and 12 months after infusion|Disease control rate (DCR), To characterize the efficacy of Anti-CD19 CAR NK Cell Therapy for Relapsed/Refractory Immune Nephropathy, 1, 3, 6, 12 and 12 months after infusion|B cell depletion rate, To characterize the efficacy of Anti-CD19 CAR NK Cell Therapy for Relapsed/Refractory Immune Nephropathy, 1, 3, 6, 12 and 12 months after infusion|B cell reconstitution, To characterize the efficacy of Anti-CD19 CAR NK Cell Therapy for Relapsed/Refractory Immune Nephropathy, 1, 3, 6, 12 and 12 months after infusion
The Effect of Vibration on Pain During Subcutaneous Heparin Injection
NCT Number: NCT06469112
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Pain|Asthma|Pulmonary Disease|Chest Disorder
Interventions: DEVICE: Vibration|OTHER: Placebo
Sponsor: Uludag University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 93
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2023-12-15
Completion Date: 2024-05-15
Locations: Bursa Uludag University Hospital, Bursa, Turkey

Summary:
Aim: The aim of this research was to examine the effect of the local vibration technique applied to the injection site during subcutaneous low molecular weight heparin (LMWH) injection.

Methods: The patients were randomly assigned to an experimental (vibration) group (n= 32), a placebo control group (n= 30), and a nonintervention control group (n= 31). Participants in the experimental group were given slight vibration to the injection site before the injection was administered; for participants in the placebo group, the device was placed on the injection site but with the vibration button kept switched off, while for the nonintervention control group, routine subcutaneous low molecular weight heparin injection was administered. The level of pain felt by the participants during the administration of the injection was assessed with a visual analog scale.

Primary Outcome Measures: pain intensity in mm, A 10-cm vertical VAS was used to evaluate the severity of pain felt by the individuals during the procedure. One end indicated lack of pain and the other the most severe pain possible. Pain severity was evaluated in millimeters., 6 months
Secondary Outcome Measures: weight, weight in kilograms, 6 months|height, height in meters, 6 months
Ankle Injuries, Imaging and Prevention Program Effectiveness in New Army Recruits
NCT Number: NCT06469099
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Ankle Sprains
Interventions: OTHER: excercises
Sponsor: University of Haifa
Collaborators: Zinman College of Physical Education and Sports Sciences
Sex: MALE
Age: ADULT
Enrollment: 700
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-03-15
Completion Date: 2026-09-15
Locations: The Academic college Levinsky-Wingate at the Wingate Institute, Netanya, Israel

Summary:
Infantry recruits will undergo a musculoskeletal examination to assess tendon, muscle, proprioception, agility, and joint status. Afterward, an exercise intervention program will be implemented, followed by a concluding evaluation.

Primary Outcome Measures: Proprioception ability, Active Movement Extent Discrimination Apparatus AMEDA, baseline, end of intervention|balance, Y balance test, baseline, end of intervention|Leg muscle strength, bilateral heel rise test, baseline, end of intervention|Hip muscle strength, hand held dynamometer, baseline, end of intervention|Ankle agility, hexagon agility hop test, baseline, end of intervention|Ankle stability, Anterior Drawer Test, musculoskeletal ultrasound for the Anterior Talofibular Ligament, baseline, end of intervention|Achilles tendon structure, Ultrasound tissue Characterization for the percentage of fibers types, baseline, end of intervention
Appendicoliths in Acute Complicated Appendicitis Patients With Abscess
NCT Number: NCT06469086
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Acute Complicated Appendicitis With Abscess
Interventions: OTHER: Clinical data collection
Sponsor: Shanghai Zhongshan Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2025-01-01
Completion Date: 2026-12-31

Summary:
Complicated appendicitis, characterized by the presence of an abscess or perforation, involves acute inflammation of the peritoneum secondary to an infection of the appendix, presenting additional challenges for management. Traditionally, the standard treatment for complicated appendicitis has been surgical intervention. However, conservative management, involving antibiotics and drainage, has emerged as a viable alternative for selected patients. Recent studies emphasize the importance of selecting appropriate antibiotics based on local resistance patterns and the patient's clinical condition. Broad-spectrum antibiotics, including those targeting anaerobic bacteria, are often preferred. In addition, advances in imaging technology, such as ultrasound-guided drainage, have improved the precision and success rates of percutaneous abscess drainage. This minimally invasive approach helps manage localized infections and can prevent the need for immediate surgery.

One factor that has gained significant attention in determining the success of conservative treatment for acute complicated appendicitis is the presence of appendicoliths-calcified deposits within the appendix. This study aims to investigate the clinical significance of appendicoliths in the conservative management of acute complicated appendicitis with abscesses.

Primary Outcome Measures: The success rate of conservative treatment, January 01, 2025 to December 31, 2025.
Secondary Outcome Measures: Postoperative complications, January 01, 2025 to December 31, 2025.|Length of postoperative hospital stay, January 01, 2025 to December 31, 2025.|The surgical approach used, January 01, 2025 to December 31, 2025.
Neoadjuvant Immunochemotherapy for Adenocarcinoma of the Esophagogastric Junction
NCT Number: NCT06469060
Acronym: TRACE
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Esophageal Cancer
Interventions: DRUG: neoadjuvant anti-PD-1 with DOC chemotherapy
Sponsor: Shanghai Chest Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 34
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-19
Completion Date: 2027-06-30
Locations: Shanghai Chest Hospital, Shanghai, Shanghai, 200030, China

Summary:
The investigators will conduct a prospective phase 2 study to evaluate the efficacy and safety of a modified neoadjuvant immunotherapy plus chemotherapy (one cycle of Tislelizumab monotherapy followed by four cycles of Tislelizumab plus Docetaxel, Oxaliplatin and Capecitabine) in patients with locally advanced resectable adenocarcinoma of the esophagogastric junction (AEG).

Primary Outcome Measures: pCR rate, The primary endpoint is a pCR rate, which is defined as the absence of any remaining tumor cells in both the main tumor and the nearby lymph nodes (ypT0N0) as per the AJCC 8th Edition TRG scoring system, Through the study completion, an average of 12 months
Secondary Outcome Measures: MPR rate, The primary endpoint is a pCR rate, which is defined as the absence of any remaining tumor cells in both the main tumor and the nearby lymph nodes (ypT0N0) as per the AJCC 8th Edition TRG scoring system, Through the study completion, an average of 12 months|Event-free survival (EFS), An event-free survival (EFS) is defined as the duration from the start of treatment until disease progression/recurrence or death from any cause, whichever occurs first, Through the study completion, an average of 36 months|Overall survival (OS), Overall survival (OS) is defined as the time from treatment to death, regardless of disease recurrence, Through the study completion, an average of 36 months|Adverse events and treatment-related adverse events, Including adverse events and complications. Incidence of adverse events using CTCAE 5.0; grade 3 treatment-related adverse events and higher-grade will be reported, Through the study completion, an average of 12 months|R0 resection rate, A R0 resection rate is defined as the rate of complete tumor removal with negative resection margin microscopically, Through the study completion, an average of 12 months|2-year recurrence-free survival between patients with postoperative ctDNA negative and postoperative ctDNA positive, patients will have ctDNA detection at 2-4 weeks after surgery, From the completion of surgery to the completion of the 2-year postoperative follow-up.
Relationship Between Serum N/OFQ and Acute Myeloid Cell Leukemia
NCT Number: NCT06469047
Acronym: RBSNAAMCL
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: AML
Interventions: DIAGNOSTIC_TEST: Enzyme-linked immunosorbent assay
Sponsor: Second Hospital of Shanxi Medical University
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-20
Completion Date: 2024-12-31
Locations: Second Hospital of Shanxi Medical University, Taiyuan, Shanxi, 030001, China

Summary:
Patients diagnosed with acute myeloid leukemia in the Second Hospital of Shanxi Medical University were selected and divided into the newly diagnosed group, the relapsed group, the complete remission group as the experimental group, and the healthy physical examination subjects as the control group. The relationship between IL-1β, catecholamine and norkephalin in peripheral blood of the experimental group and the control group was observed. According to the literature, the experimental group was significantly higher than the control group. In the experimental group, the newly diagnosed group was higher than the relapse group, and the relapse group was higher than the complete remission group, and the correlation was positive, and the difference was statistically significant.

Primary Outcome Measures: N/OFQ, Serum N/OFQ levels, 24 hours|IL-1β, Serum IL-1β levels, 24 hours|NE, Serum NE levels, 24 hours
Use of Intra-aortic Balloon Pump Before Surgery for Acute Myocardial Infarction
NCT Number: NCT06468982
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Acute Myocardial Infarction|Coronary Artery Disease|Coronary Bypass Graft Stenosis of Autologous Vessel|Troponin|IABP - Disorder of Intra-Aortic Balloon Pump
Interventions: OTHER: Intra-aortic Balloon Pump
Sponsor: Ataturk University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 156
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2021-05-01
Completion Date: 2023-12-31
Locations: Atatürk University, Yakutiye, Erzurum, 25100, Turkey|Atatürk University, Erzurum, 25100, Turkey

Summary:
The optimal timing of surgery in patients with acute myocardial infarction (AMI) and the utilization of preoperative intra-aortic balloon pumps (IABP) in these patients are subjects of ongoing discussion and disagreement. This study aimed to investigate the effects of preoperative IABP on troponin levels, surgical timing, and intraoperative and postoperative outcomes for patients with AMI who undergo coronary artery bypass grafting (CABG).

Primary Outcome Measures: rate of decrease of high sensitive cardiac troponin, Daily comparison of repeated hsCTI measurements in both groups, 10 days
Secondary Outcome Measures: in-hospital mortality, Deaths occurring in the first 30 days after the operation will be defined as mortality., 30 days
Enhanced vs. Routine Follow-Up After Total Gastrectomy for Advanced Gastric Cancer: A Randomized Controlled Trial
NCT Number: NCT06468969
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Gastric Cancer|Total Gastrectomy|Postoperative Care|Quality of Life|Follow-up
Interventions: OTHER: Enhanced Follow-up
Sponsor: Fudan University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 158
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-01
Completion Date: 2029-07-01

Summary:
The goal of this clinical trial is to compare the effectiveness of enhanced follow-up with standard follow-up in postoperative patients with advanced gastric cancer who have undergone radical gastrectomy. The main questions it aims to answer are:

Can enhanced follow-up alleviate symptom burden and improve quality of life? What is the impact of enhanced follow-up on overall survival rates at 3 and 5 years post-surgery?

Participants will:

Be randomly assigned to either the enhanced follow-up group or the standard follow-up group.

Undergo comprehensive symptom, nutritional, and psychological assessments every 3 weeks (enhanced follow-up group).

Receive routine postoperative follow-up including medical examinations and treatments as needed, with additional assessments only when necessary (standard follow-up group).

Researchers will compare the enhanced follow-up group with the standard follow-up group to see if enhanced follow-up can improve quality of life and increase overall survival rates at 3 and 5 years post-surgery.

Outcomes will be measured using the EORTC QLQ-C30 quality of life questionnaire and overall survival rates. This prospective, single-center, randomized controlled clinical trial will span 5 years from the approval by the institutional ethics committee and will include 158 patients.

Primary Outcome Measures: Quality of Life Improvement, Measurement of quality of life improvement in postoperative advanced gastric cancer patients using the EORTC QLQ-C30 questionnaire. The assessment will include various dimensions such as physical functioning, emotional well-being, social functioning, and overall health status., Assessed every 6 weeks from the 4th week post-surgery until 6 months post-chemotherapy completion.
Secondary Outcome Measures: 3-Year Overall Survival Rate, The proportion of patients who are still alive 3 years after surgery., 3 years post-surgery.|5-Year Overall Survival Rate, The proportion of patients who are still alive 5 years after surgery., 5 years post-surgery.
Polatuzumab Vedotin and Zanubrutinib Plus R-CHP for Patients With Newly Diagnosed Untreated Non-GCB DLBCL
NCT Number: NCT06468943
Status: ENROLLING_BY_INVITATION
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Effects of Chemotherapy|Safety Issues
Interventions: DRUG: Polatuzumab Vedotin|DRUG: Zanubrutinib|DRUG: Rituximab|DRUG: Cyclophosphamide|DRUG: Doxorubicin|DRUG: Prednisone
Sponsor: The First Affiliated Hospital of Soochow University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-07-01
Completion Date: 2028-05-01
Locations: The First Affiliated Hospital of Soochow University, Suzhou, Nanjing, 215000, China

Summary:
Aim of this study will evaluate the efficacy and safety of Polatuzumab Vedotin and Zanubrutinib in combination with R-CHP for newly diagnosed untreated Non-GCB DLBCL Patients with extranodal involvement.

Primary Outcome Measures: Progression-free Survival（PFS）, The time between enrollment and tumor occurrence (in any aspect) progression or (for any reason) death, From date of enrollment until the date follow up for 2 years after the treatment or progression disease or date of death for any cause.
Secondary Outcome Measures: Objective Response rate（ORR）, The proportion of patients who achieved complete or partial response in efficacy evaluation at the end of treatment, From date of enrollment until the date follow up for 2 years after the treatment or progression disease or date of death for any cause.|Complete Response（CR）, The proportion of patients who achieved complete response in efficacy evaluation at the end of treatment, From date of enrollment until the date follow up for 2 years after the treatment or progression disease or date of death for any cause.|Duration of Response（DOR）, It refers to the time from the first assessment of a tumor as CR or PR to the second assessment as PD (Progressive Disease) or death from any cause., All time in the study|Overall Survival, The time between enrollment to death(for any reason) ., From date of enrollment until the date follow up for 2 years after the treatment or progression disease or date of death for any cause.|Adverse Events(AEs), All treatment-related adverse events that occur during patient treatment and follow-up., From date of enrollment until the date follow up for 2 years after the treatment or progression disease or date of death for any cause.
Other Outcome Measures: Exploratory study endpoint, Exploring the therapeutic response of subjects with different genotypes to Pola+ZR-CHP regimen using Next-generation sequencing(NGS)., From date of enrollment until the date follow up for 2 years after the treatment or progression disease or date of death for any cause.