pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Plasma Pharmacological Monitoring of M Penicillins in Methicillin-sensitive Staphylococcus Aureus Bacteremia
NCT Number: NCT06495697
Acronym: DOSESACLOXA
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Staphylococcus Aureus Infection
Sponsor: University Hospital, Strasbourg, France
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-07-19
Completion Date: 2024-07-19
Locations: Service des Maladies Infectieuses et Tropicales - CHU de Strasbourg - France, Strasbourg, 67091, France

Summary:
The treatment of Methicillin-sensitive Staphylococcus aureus bacteremia is based on the first-line use of cefazolin or M penicillins (oxacillin and cloxacillin). The use of the latter is recommended at high doses (150-200 mg/kg/24h). In a study on infectious endocarditis, 52 of 56 patients with staphylococcal endocarditis treated with (cl)oxacillin were overdosed with the recommended doses. Although the main mechanism of renal toxicity described for M penicillins is immunoallergic, a frequent overdose is observed in cases of acute renal failure with M penicillins. There is also a significant association between overdose and risk of neurological toxicity. The currently recommended treatment duration is a minimum of 14 days of IV treatment from the first negative blood culture, which leaves room for carrying out a plasma assay and possible dosage adjustment subsequently.

Overdose is a risk factor for nephrotoxicity and neurotoxicity. Plasma level could be predictive of clinical success. Systematic plasma dosing would reduce the risk of toxicity and improve the clinical cure rate.

Primary Outcome Measures: Clinical healing, Blood culture negative at 48-96 hours compared to the start of antibiotic therapy, day 30 after infection
Impact of Prebiotics in Ulcerative Colitis
NCT Number: NCT06495658
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Crohn Disease|Ulcerative Colitis
Interventions: DIETARY_SUPPLEMENT: Prebiotic
Sponsor: University of California, Los Angeles
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 70
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: OTHER
Start Date: 2024-07-09
Completion Date: 2027-12-31
Locations: UCLA, Los Angeles, California, 90095, United States

Summary:
The cause of inflammatory bowel disease (IBD) is currently unknown, although partly attributed to interactions among genetic risk polymorphisms, environmental factors, gut microbiome, and host immunity. Diet, particularly those with plant-based products, have been shown in prior research to improve gut microbial composition, which has been linked to different IBD-related outcomes. This study is interested in evaluating the impact of prebiotics on gut microbiome composition and gut health in patients with IBD.

Dietary composition will be assessed at baseline and over the course of 16 weeks. Participants will be randomized to either consume an 8-week course of prebiotic supplementation beginning at week 0 or week 8. Stool samples will be collected at weeks 0 and 8. The stool will be analyzed for cross-sectional and longitudinal fecal microbial changes associated with different prebiotic and diet consumption patterns in the context of heterogeneous disease characteristics.

Primary Outcome Measures: Clinical response, Clinical response will be defined as a reduction of Simple Colitis Clinical Activity Index (SCCAI). Range of SCCAI is 0-20 (higher is more severe)., Week 8|Microbial composition, Microbial composition includes a measurement and characterization of the relative quantity of genera and species., Week 8
Secondary Outcome Measures: Clinical remission, Clinical remission will be defined as a Simple Colitis Clinical Activity Index (SCCAI) \< 4. Range of SCCAI is 0-20 (higher is more severe)., Week 8|Clinical response, Clinical response will be defined as a reduction of Simple Colitis Clinical Activity Index (SCCAI). Range of SCCAI is 0-20 (higher is more severe)., Week 16|Clinical remission, Clinical remission will be defined as a Simple Colitis Clinical Activity Index (SCCAI) \< 4. Range of SCCAI is 0-20 (higher is more severe)., Week 16|Microbial composition, Microbial composition includes a measurement and characterization of the relative quantity of genera and species., Week 16
Miss Rate of Gastric Neoplasms Under Computer-aided Endoscopy
NCT Number: NCT06495645
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Gastric Neoplasm|Artificial Intelligence
Interventions: DEVICE: AI-assisted upper gastrointestinal endoscopy
Sponsor: The University of Hong Kong
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1853
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2026-12-31
Locations: Queen Mary Hospital, the University of Hong Kong, Hong Kong, Hong Kong

Summary:
This prospective randomized trial compares AI-assisted upper gastrointestinal endoscopy with high definition upper gastrointestinal endoscopy in term of missed rate of gastric neoplasm. The investigators hypothesize the miss rate of high definition upper gastrointestinal endoscopy is higher than AI-assisted upper gastrointestinal endoscopy.

Primary Outcome Measures: Gastric neoplasia miss rate, the number of newly detected gastric neoplasia in the second examination divided by the total number of gastric neoplasia detected in both examinations for each patient., during the intervention
Secondary Outcome Measures: Gastric neoplasia detection rate, The proportion of patients with one or more gastric neoplasms detected in the first examination, during the intervention|The biopsy rate, The proportion of patients who had a biopsy sample taken as a result of the first examination, during the intervention|The number of gastric neoplasms per patient, The total number of gastric neoplasms detected in the first examination divided by the total number of patients, during the intervention|The miss rate of patients with gastric neoplasms, The number of patients with a newly detected gastric neoplasm in the second examination divided by the total number of patients with gastric neoplasms detected in both examinations, during the intervention|The positive predictive value (PPV) for gastric neoplasms, The number of detected gastric neoplasms divided by the number of all targeted lesions in the first examination, during the intervention|Inspection time, The procedure time of the examinations minus the time taken to obtain a biopsy sample, measured from the passage of the endoscope through the gastroesophageal junction until the completion of the whole examination of the gastric cavity, excluding the inspection time of the duodenum and the biopsy time, during the intervention|The macroscopic and histological types of detected and missed neoplasia in the first examination, The macroscopic and histological types of detected and missed neoplasia in the first examination, during the intervention|Number of biopsy per patient in the first arm, Number of biopsy per patient in the first arm, during the intervention|Percentage of positive biopsy, The number of gastric neoplasm detected divided by total number of biopsy in the first arm, during the intervention
Scheduled or as Needed Pain Regimen?
NCT Number: NCT06495632
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Pain, Postoperative
Interventions: DRUG: Motrin and narcotic
Sponsor: Cape Fear Valley Health System
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 90
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2027-07-31
Locations: Cape Fear Valley Medical Center, Fayetteville, North Carolina, 28304, United States

Summary:
The aim of this study is to determine feasibility of a randomized controlled trial and estimates of efficacy for pain control of a scheduled pain regimen versus an as needed pain regimen for participants undergoing same day surgery procedures.

Primary Outcome Measures: Feasibility of trial, To measure feasibility of the study, the following data will be collected:

1. Number of participants eligible for the study
2. Number of participants contacted about the study
3. Number of participants consented
4. Number of participants being at least 80% adherent to medication protocol
5. Number of drop-outs in the study and reason for drop out
6. Number of Adverse Events reported to study personnel. For all non-consented participants, only counts will be included (e.g., 5 participants who refused to consent), no identifying or private information will be collected., 2 weeks
Secondary Outcome Measures: Estimate of effect size pain control, Daily diary of pain (10 point scale), 2 weeks
Integrative Intervention Strategies for Binge Eating in Patients With Overweight or Obesity
NCT Number: NCT06495619
Acronym: BE-side
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Binge Eating|Overweight and Obesity
Interventions: BEHAVIORAL: treatment-as-usual|BEHAVIORAL: combined TAU and guided self-help|BEHAVIORAL: combined TAU, GSH, and biofeedback
Sponsor: G. d'Annunzio University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2025-06-30

Summary:
The main goal of the clinical trial is to compare the short- and long-term outcomes of three 12-week interventions among outpatients with overweight/obesity and binge eating (BE):

1. treatment-as-usual for weight loss (TAU);
2. combined TAU and guided self-help for improving eating behaviors (TAU+GSH);
3. combined TAU, GSH, and biofeedback (TAU+GSH+BF). The primary outcomes will be self-reported reduction of days with objective BE episodes (OBEs).

The secondary outcomes will be impulsivity, emotion dysregulation, interoceptive awareness, distress, physiological correlates of arousal (skin conductance and heart rate variability), and inflammatory biomarkers.

The TAU+GSH arm is expected to be comparable to the TAU+GSH+BF arm in reducing the number of days with OBEs but is expected to be significantly less effective in improving secondary outcomes (impulsivity, emotional dysregulation, interoceptive awareness, distress, physiological inflammatory markers). The TAU arm is expected to show significant inferiority regarding the primary and secondary outcomes and cost-effectiveness compared to the TAU+GSH and TAU+GSH+BF conditions.

Primary Outcome Measures: objective BE episodes (OBEs), The primary outcomes will be self-reported reduction of days with objective BE episodes (OBEs), 12-week follow-up-1 4-month follow-up-2 (after the end-of-treatment)
Secondary Outcome Measures: psychological variables, The secondary outcomes will be impulsivity, emotion dysregulation, interoceptive awareness, distress., (T0) baseline; (T1)12-week follow-up-1; (T2) 4-month follow-up-2 (after the end-of-treatment)|physiological correlates of arousal, The secondary outcomes will be skin conductance and heart rate variability., (T0) baseline; (T1)12-week follow-up-1; (T2) 4-month follow-up-2 (after the end-of-treatment)|inflammatory biomarkers, The secondary outcomes will be ClpB protein and IgG, (T0) baseline; (T1)12-week follow-up-1; (T2) 4-month follow-up-2 (after the end-of-treatment)
Effects of Ocrelizumab Treatment on Immune Cells in Lymph Nodes in Multiple Sclerosis
NCT Number: NCT06495593
Acronym: OCREFINA
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Multiple Sclerosis, Relapsing-Remitting
Interventions: DRUG: Ocrelizumab
Sponsor: University of California, San Francisco
Collaborators: Genentech, Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 5
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-10-01
Completion Date: 2025-06-30
Locations: University of California, San Francisco, San Francisco, California, 94158, United States

Summary:
B cell-depleting therapies, such as ocrelizumab, are among the most effective medications currently available for the treatment of multiple sclerosis (MS). This suggests that B cells play a very important role in MS. While B cells are rapidly eliminated from the blood of patients treated with medications like ocrelizumab, little is known about how effectively B cells are eliminated from lymph nodes, which are important sites of B cell activation. This study is being conducted to determine to what extent B cells are targeted in lymph nodes following ocrelizumab treatment, which may have important consequences for long-term MS outcomes.

Primary Outcome Measures: Lymphocyte analysis, Percent reduction in B cells and T cell subsets in lymphoid tissue of MS patients following ocrelizumab treatment., 3 months
Optic Nerve Stimulation To Prevent Visual Deficits After Endoscopic Cranial Approaches
NCT Number: NCT06495580
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Optic Nerve Injuries|Sellar Tumor|Skull Base Neoplasms
Interventions: PROCEDURE: Optic Nerve Stimulation
Sponsor: University of California, San Francisco
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-08
Completion Date: 2026-12
Locations: University of California, San Francisco, San Francisco, California, 94143, United States

Summary:
Assessing the function of the optic nerve is paramount during various neurosurgical procedures. Effective optic nerve monitoring has remained elusive as Visual Evoked Potentials (the current existing tool) provides only diffuse and delayed assessment of nerve function. Here, the investigators propose a prospective study involving adult patients (aged 18 years and older) undergoing endonasal or open cranial approaches around the optic nerves, who will receive pre- and post-operative visual evaluations. During surgery, the optic nerve and chiasm will be stimulated, and the response will be recorded in both eyes and the occipital cortex via skin electrodes. The investigators aim to utilize anterograde optic nerve microstimulation to assess the nerve's integrity during open and endoscopic cranial approaches. Electrophysiological readings will be acquired, as is routine in the operating room, by our team of experts, and intraoperative findings will be correlated with post- surgical clinical outcomes. Our objective is to utilize existing technology in the operating room to safely and effectively monitor optic nerve function during surgery.

Primary Outcome Measures: Visual Deficits, Patients that received our intervention will be evaluated post operatively for regular standard of care six weeks post-operatively. During visual evaluation, the PI of this study will determine post-operative visual field and visual acuity. These parameters will be compared to pre-operative visual acuity and visual field status., 6 weeks after surgery date.
Proof of Concept Creatine Supplementation for Homocystinuria Study
NCT Number: NCT06495567
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Homocystinuria
Interventions: DIETARY_SUPPLEMENT: Creatine|DIETARY_SUPPLEMENT: Dietary methionine tracer and protein intake
Sponsor: University of British Columbia
Sex: MALE
Age: ADULT
Enrollment: 6
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-08-19
Completion Date: 2024-12-31
Locations: BC Children's Hospital Research Institute, University of British Columbia, Vancouver, British Columbia, V5Z4H4, Canada

Summary:
Homocystinuria is a rare and inherited metabolic disorder, people with this condition don't have an enzyme needed to break down an amino acid called homocysteine. When the body can't break down the homocysteine made from another amino acid methionine, it becomes toxic to the heart, brain, and bones. We are constantly eating methionine, a building block of protein, so a common treatment is eating a low-protein diet with medical foods and vitamin pills. This can be hard to follow due to bad tastes and missing out on foods a person enjoys, especially in children.

The goal of this study is to provide participants with a supplement containing creatine, another amino acid related to methionine and homocysteine, and learn if it lowers homocysteine production in healthy adult men. We would ultimately like to see if creatine supplements are a potential alternate treatment of Homocystinuria in this proof of concept study, before studying individuals with the condition.

Researchers in this study want to know:

* How does the bodies digestion of isotope methionine change in breath and urine when creatine is taken in healthy young adult men?
* How do levels of homocysteine, methionine and related metabolites change in the blood when creatine is taken by healthy young adult men?

Participants will:

* Complete two (2), 8-hour study days on-site.
* Eat a lower protein diet for one (1) week before the first study day, and eat a lower protein diet with creatine supplements for one (1) week before the second study day.
* During both study days eat special hourly meals of controlled amino acids and nutrients, along with a methionine isotope. (An isotope is a stable labelled amino acid that is colourless, odorless, tasteless, and safe for consumption. In the lab we can detect this isotope in breath and urine samples collected during the study day).
* Provide samples of breath, urine and blood. (Researchers will also take body measurements (height weight), and use non-invasive tests to measure body composition and energy needs).

Primary Outcome Measures: Carbon 13 Oxidation, Urine and breath samples will be collected to measure the rate of L-\[1-13C\]methionine oxidation, 8 hours
The Real World Study of Pyrotinib in the Treatment of Advanced Breast Cancer With HER2 Positive
NCT Number: NCT06495541
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Breast Cancer|RWS|Pyrotinib
Interventions: DRUG: Pyrotinib
Sponsor: Tianjin Medical University Cancer Institute and Hospital
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 500
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2028-07-30

Summary:
Research object：Planned to receive pyrrolidine for HER2 positive first-line breast cancer patients

Research purpose:

Main research objectives:

To observe the efficacy and safety of pyrrolidine in the treatment of HER2 positive advanced first-line breast cancer.

Secondary research objectives:

1. Evaluate the correlation between patient characteristics in the late stage of treatment and specific treatment plans and clinical outcomes Sex (including safety outcomes)
2. Evaluate whether and how previous anti HER2 therapy affects the efficacy of subsequent pyrrolitinib treatment
3. To observe the efficacy of pyrrolitinib in patients with brain metastasis of HER2 positive breast cancer

Research endpoint:

Main research endpoint:

Progression free survival (rwPFS)

Secondary study endpoint:

Efficacy endpoints: objective response rate (rwORR), disease control rate (rwDCR), until treatment failure Time to Flight (TTF), Total Survival (OS), Security

Primary Outcome Measures: PFS, The time from randomization to disease progression evaluated by researchers for patients, 24.3months
Bliss DTx Assessment During Course Care Including Port-A-Catheter Setting
NCT Number: NCT06495528
Acronym: EPATPAC
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cancer
Interventions: DEVICE: Pain management with BLISS DTx|OTHER: Pain Management with site standard of care sedation protocol
Sponsor: Butterfly Therapeutics
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 318
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-06-12
Completion Date: 2025-05-12
Locations: CHU Angers, Angers, 49933, France

Summary:
Setting a Port-a Cath is performed in a surgical room, under ambulatory, by a specialist, under local anesthesia. This Port-a Cath is placed in the upper part of the thorax, under the clavicle, and facilitate the administration of certain anticancer drugs or to inject other treatments throughout the course of care.

Setting a Port-a Cath is painful and stressful. In addition to local anesthesia, patients are often offered a sedation: anxiolytics, hypnotics or inhalation of MEOPA.

Butterfly Therapeutics has developed a Digital Therapeutics (DTx) called Bliss DTx which uses virtual reality augmented by sound and visual stimuli. A first clinical study with Bliss DTx showed that the pain level was not significantly different between "Bliss DTx" arm and "MEOPA" arm when performing osteomedullary biopsy.

This study is based on the hypothesis that Bliss DTx use would :

* Be clinically equivalent to a standard protocol (use of hypnotics and/or anxiolytics and/or MEOPA and/or hypnosis conversational) to manage pain during Port-a Cath setting under local anesthesia
* Reduce anxiety before setting a Port-a Cath
* Provide greater satisfaction with the treatment process from patient point of view
* Have organizational impacts, some of which could be economically valued

Primary Outcome Measures: Pain level, Maximum pain level during Port-A-Cath setting will be assessed using Visual Analog Scale : from 0 (no pain) to 10 (intolerable), 1 day|Patient anxiety, Patient anxiety before Port-A-Cath setting will be assessed with Hamilton score.

Score 10 to 13: mild depressive symptoms. Score 14 to 17: mild to moderate depressive symptoms. Score greater than 18: moderate to severe depressive, 1 day|Patient satisfaction, The overall experience score and patient satisfaction will be assessed using the e-Satis questionnaire in ambulatory surgery (MCO CA) at the end of the treatment course. This a specific french questionnaire without global final score. There are only questions with following rating : poor, weak, medium, good, excellent, 1 day
Efficacy and Safety of Dalpiciclib Plus Toremifene in the Treatment of Advanced First-line HR Positive and HER2 Negative Breast Cancer: a Multicenter, Single Arm, Exploratory Phase II Clinical Study
NCT Number: NCT06495515
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: CANCER|BRAEST CANCER|Late Frontline
Interventions: DRUG: Dalpiciclib，Toremifen
Sponsor: Tianjin Medical University Cancer Institute and Hospital
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 36
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2026-06-30

Summary:
Experimental population:Advanced first-line HR+, HER2 metastatic breast cancer patients

Research endpoint:

Main research endpoint:

PFS evaluated by researchers (according to RECIST 1.1 standard)

Secondary study endpoint:

ORR、CBR、DCR、OS The incidence of adverse events (AE) and severe adverse events (SAE)

Exploratory study endpoint:

Tumor infiltrating lymphocytes (sTIL) Peripheral blood lymphocyte ratio Distribution of fecal microbiota Research overall design:This study adopts a prospective, single arm design, and plans to include 36 postmenopausal or premenopausal/perimenopausal patients with metastatic breast cancer who are HR positive and HER2 negative, and receive maintenance treatment with darcy plus toremifene. In this study, the screening period did not exceed 28 days. After completing the screening examination and evaluation, eligible subjects entered the study treatment period and received maintenance treatment with darcilib combined with toremifen, for a period of 4 weeks until disease progression, intolerable toxicity, withdrawal of informed consent, or termination of medication as determined by the investigator. Conduct research according to the plan regulations Treatment and visits. Perform tumor imaging evaluation every 2 cycles (8 weeks ± 7 days) during the first 13 treatment cycles (52 weeks) of the treatment period; Afterwards, tumor imaging evaluation will be conducted every 3 cycles (12 weeks ± 7 days). Subjects should visit the research center at the end of treatment/withdrawal from the study to complete corresponding safety checks and imaging evaluations; And visit the research center 28 days after the last treatment to complete the corresponding safety assessment.

Primary Outcome Measures: PFS, The time from randomization to disease progression evaluated by researchers for patients, 30.6 months
To Disclose a Child Sexual Abuse Within Child & Adolescent Psychiatry Services
NCT Number: NCT06495502
Acronym: REVEAL
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Child Sexual Abuse
Interventions: OTHER: semi-structured interview
Sponsor: Anne Revah-Levy
Sex: ALL
Age: CHILD, ADULT
Enrollment: 90
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-01-01
Completion Date: 2026-06-30
Locations: Hôpital Louis Mourier, Colombes, Hauts De Seine, 92700, France|CHVictorDupouy, Argenteuil, Ile De France, 95100, France|Pôle Hospitalo-Universitaire de Psychiatrie de l'enfant et l'adolescent de Rennes, Rennes, Ille-et-Vilaine, 35703, France|Hopital Femme Mère Enfant, Hospices Civils de Lyon, Bron, Rhone, 69500, France|CHU Rouen/CH Rouvray, Rouen, Seine Maritime, 7600, France

Summary:
Mental health professionals investigating child sexual abuse (CSA) among children and adolescents is a major public health challenge. Many studies have shown the obstacles to disclose, with professionals having difficulties to address this issue and survivors having difficulties to disclose. Many children, old enough to tell what happened to them, would disclose this traumatic event only many years after, but they suffer from psychiatric and/or somatic disorders meanwhile. CSA survivors presenting psychiatric symptoms very often receive a psychiatric treatment within child \& adolescent psychiatric (CAP) departments.

The investigators aim to better understand what is at stakes around the issue of disclosure of CSA by teenagers within CAP services, so to draw concrete implications to improve investigation efficacy and disclosure support by mental health professionals. To date, no study has ever explored these issues of investigating and disclosing CSA in CAP services. Qualitative methods are quite relevant here, aiming as they do, to in-depth explore complex issues, through the lived experience of the stakeholders.

The main objective of this study is to explore the lived experience of disclosing CSA among (i) adolescents and young adults followed in a CAP service, (ii) parents, and (iii) child \& adolescent mental health professionals working in CAP services who have experienced a CSA disclosure. Crossing perspectives will bring answers to the complex question: "how to disclose a CSA within a CAP service?" and will lead to concrete implications to improve treatment of children and adolescents with an history of CSA.

It is an exploratory qualitative multi-center design following the IPSE approach - Inductive Process to analyze the structure of lived experience-.

Primary Outcome Measures: Lived experience of disclosure of child sexual abuse, Participant-reported experiences in child sexual abuse disclosure as assessed using the Inductive Process to analyze the Structure of lived Experience (IPSE), 2 years
Lonsurf® (Trifluridine/Tipiracil) Plus Chemotherapy in Metastatic Colorectal Cancer Prospective Study in Taiwan
NCT Number: NCT06495463
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Metastatic Colorectal Cancer
Interventions: DRUG: Trifluridine/tipiracil
Sponsor: Chang Gung Memorial Hospital
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 110
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2022-03-19
Completion Date: 2024-12-31
Locations: Chang-Gung Memorial Hospital, Linkou, Linkou, Taiwan

Summary:
Primary Endpoint : To evaluate the Disease control rate (DCR)

Secondary Endpoints:

To evaluate the Progression-free survival (PFS), Overall survival(OS) and Safety profile

Primary Outcome Measures: Disease control rate (DCR), The endpoints Disease Control Rate (DCR) is defined as the proportion of patients in whom the best overall response is determined as complete response (CR), partial response (PR) or stable disease (SD)., Tumor response will be judged according to RECIST v 1.1 criteria within every 8 weeks(± 2 week) in treatment period. The evaluation period is up to 24 months from the date of ICF is signed to first recorded progress or death whichever occurs first.
Secondary Outcome Measures: Progression-free survival (PFS), Progression-free survival (PFS) refers to the first treatment of trifluridine/tipiracil to disease progression or death., The evaluation period is up to 24 months from the date of ICF is signed to the date of first recorded progress.|Overall survival(OS), Overall survival (OS) is defined from the first treatment of Lonsurf® to death., The evaluation period is up to 48 months from the date of ICF is signed to the date of death.|Safety profile, All adverse events (AEs) will be summarized and listed. All adverse events occurring between the first drug intake and 30 days (inclusive) after the last administration of trial medication will be collected, and graded according to the common terminology criteria for adverse events (CTCAE) version 5.00., The evaluation period is up to 24 months from all adverse events occurring between the first drug intake and 30 days (inclusive) after the last administration of trial medication will be collected.
Preliminary Safety and Efficacy Study of Extracellular Vesicle Infusion in the Intervention of Age-related Phenotypes With Impaired Glucose Tolerance.
NCT Number: NCT06495437
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Impaired Glucose Tolerance
Interventions: BIOLOGICAL: Intravenous infusion of extracellular vesicle preparation derived from Wharton's jelly mesenchymal stem cells.
Sponsor: BEAUTECH
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2026-12-31

Summary:
The objective of this exploratory study was to evaluate the initial safety of human mesenchymal stem cell-derived extracellular vesicle infusion in an age-related phenotype with impaired glucose tolerance

Primary Outcome Measures: safety evaluation, Incidence of adverse events from baseline to the end of 12 weeks. The frequency and frequency of adverse events (including injection site reactions) were analyzed. The number of cases and cases of adverse events, adverse reactions, AES leading to fall off, SAE, aes of different severity, AES leading to death were calculated respectively, and a detailed list was provided. The incidence rate was calculated using the number of people in each safety dataset as the denominator, and if necessary, Chi-square test or Fisher exact probability method was used for inter-group comparison., 0-12 weeks
Secondary Outcome Measures: Effectiveness evaluation, glycated hemoglobin -1, 0-12 weeks|Effectiveness evaluation, endocrine hormones (gonadal hexa, DHEA, IGF-1), 0-12 weeks|Effectiveness evaluation, blood glucose level, 0-12 weeks|Effectiveness evaluation, insulin secretion index, 0-12 weeks|Effectiveness evaluation, HOMA-β indexes, 0-12 weeks|Effectiveness evaluation, HOMA-IR indexes, 0-12 weeks
Observational Study to Evaluate the Efficacy of Sustained QUTENZA® Use in Painful Diabetic Peripheral Neuropathy
NCT Number: NCT06495424
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Peripheral Diabetic Neuropathy|Painful Diabetic Neuropathy
Interventions: DRUG: Capsaicin 8% Patch Kit,1
Sponsor: Averitas Pharma, Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 150
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08
Completion Date: 2025-12
Locations: Celéri Health, Inc, Conshohocken, Pennsylvania, 19428, United States|Clinical Research Strategies, LLC, Wexford, Pennsylvania, 15090, United States

Summary:
The purpose of this post-market observational study is to provide real-world evidence to support the repeated use of QUTENZA in patients with PDPN and to evaluate the potential for pain and concomitant medication use reduction.

Primary Outcome Measures: Efficacy of capsaicin 8% topical system with repeat applications, The change in pain intensity post capsaicin 8% topical system administrations from baseline with repeat applications every 12 weeks (up to 3 applications), 36 weeks
Pranayama and Deep Breathing Exercises Sleep Quality After Laparoscopic Cholecystectomy
NCT Number: NCT06495411
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cholecystectomy, Laparoscopic
Interventions: OTHER: pranayama-|OTHER: deep breathing-|OTHER: control
Sponsor: Ataturk University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 66
Study Design: Allocation: RANDOMIZED|Intervention Model: FACTORIAL|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2023-03-01
Completion Date: 2024-07-01
Locations: Atatürk University, Erzurum, 25240, Turkey

Summary:
This study explores the impact of pranayama and deep breathing exercises on alleviating shoulder pain and improving sleep quality following laparoscopic cholecystectomy.

Primary Outcome Measures: Evaluation of pain after laparoscopic cholecystectomy with visual analogue scale in deep breathing group, pranayama group and control groups., On the visual analogue scale, 0 points mean no pain, and 10 points mean unbearable pain., Pain was evaluated before surgery. After surgery, pain was evaluated before and after exercise, at the 6th hour, 12th hour, 24th hour and at discharge.
Secondary Outcome Measures: Evaluation of sleep of patients after laparoscopic cholecystectomy with the Richard Campbell Sleep Scale, Sleep is evaluated on a chart between 0 and 100. A score between "0-25" from the scale indicates very poor sleep, and a score between "76-100" indicates very good sleep., The sleep quality of the patients was measured before the surgery and in the morning of the second day of the surgery.
Effect of Immunization Education Program on Parental Vaccine Hesitation
NCT Number: NCT06495359
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Nurse's Role
Interventions: OTHER: immunization education program
Sponsor: Bilecik Seyh Edebali Universitesi
Collaborators: The Scientific and Technological Research Council of Turkey
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: OTHER
Start Date: 2024-03-01
Completion Date: 2025-03-01
Locations: Asli Akdeniz Kudubeş, Bilecik, Turkey

Summary:
Not administering vaccines due to vaccine hesitancy is both a potential public health problem and a difficult and risky situation for healthcare professionals. Health sector workers play a very important role in vaccinating families. As public awareness increases, interest in these vaccines is likely to increase. Made works; It shows that healthcare professionals and physicians establishing trust and communicating effectively with vaccine recipients and parents is one of the most effective ways to eliminate vaccine hesitations. They stated that in order for childhood vaccines to be administered at a high rate, effective communication should first be established with parents. This project aimed to determine the effect of the immunization education program on parents' vaccine hesitancy. The project is designed as a randomized controlled study and will consist of experimental and control groups. An education program regarding immunization will be applied to the parents in the experimental group. The originality of this project is the evaluation of the effect of the immunization education program applied to parents whose children are hospitalized on vaccine hesitancy. Although studies on vaccine hesitancy in parents have increased in recent years, most of them consist of descriptive studies aimed at determining the level of vaccine hesitancy and affecting factors. No intervention studies on the effect of immunization education in parents on vaccine hesitancy have been found.

Primary Outcome Measures: Parental Vaccination Hesitancy Scale mean score, The effect of the applied education on the mean score of the Parental Vaccination Hesitancy Scale will be evaluated., up to 10 months
Identification and Characterisation of Sleep Disorders in a Population of Patients With Non-small Cell Lung Cancer
NCT Number: NCT06495346
Acronym: SomOncoP
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Cell Lung Cancer|Sleep Disorders
Interventions: OTHER: self-questionnaires exploring
Sponsor: University Hospital, Strasbourg, France
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-12-11
Completion Date: 2025-06-11
Locations: HUS, Strasbourg, Grand Est, 67117, France

Summary:
This exploratory study will identify and characterise disorders frequently reported by patients as contributing to or altering their quality of life. This will enable a decision tree to be drawn up for diagnosis, referral and treatment of the sleep disorders collected, tailored to patients in this population.

This decision tree should help to improve the management of patients with a cancer diagnosis presenting with sleep disorders.

Primary Outcome Measures: Score sleep quality criteria (Pittsburgh Sleep Quality Index), The overall score ranging from 0 to 21 points. A score of 0 means that there is no difficulty sleeping, and 21 indicates, on the contrary, major difficulties., Every 14 days for 2 months
Fecal Microbiota Analysis of PNPLA3 Polymorphism in Hispanic Patients With MASLD
NCT Number: NCT06495333
Acronym: MPM
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Metabolic Dysfunction-associated Steatotic Liver Disease
Sponsor: Fundacion de Investigacion Science and Education
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-05
Completion Date: 2025-08-20
Locations: FDI Clinical Research, San Juan, 00927, Puerto Rico

Summary:
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) is the most common cause of liver disease worldwide. The condition is defined by fat accumulation exceeding 5% of liver weight not explained by at-risk alcohol intake. Risk factors include obesity, diabetes, genetic variants, dietary factors, and gut microbiota alterations. However, the interdependence of these factors and their individual impact on disease severity remain unclear. The investigators aim to investigate the changes in the gut microbiome of Hispanics living in Puerto Rico with MASLD associated with wild-type and mutated genotype status of PNPLA3 rs738409, a strong genetic contributor to MASLD. In this cross-sectional study, blood and fecal samples will be collected from participants who have completed a non-invasive transient elastography test (FibroScan) to measure the extent of hepatic steatosis (fat in the liver). Genotyping for the PNPLA3 rs738409 variant will be conducted. Fecal samples will be collected to analyze the V4 region of the 16S rRNA gene for intestinal microbiota characterization. Alpha and beta diversity analysis will be measured by MASLD status and PNPLA3 genotype to evaluate biodiversity within and between samples.

Primary Outcome Measures: Microbiota characterization, To determine the changes in the gut microbiome of Hispanics living in Puerto Rico with MASLD associated to wild-type and mutated genotype status of PNPLA3 rs738409, a strong genetic contributor to MASLD., 1 year|Microbiota diversity based on eating patterns, To determine microbiome diversity in Hispanics with different eating patterns., 1 year
Effect of Rational Drug Education on the Attitudes of Parents of Hospitalized Children
NCT Number: NCT06495320
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Nursing Caries
Interventions: OTHER: Rational drug use education
Sponsor: Bilecik Seyh Edebali Universitesi
Collaborators: The Scientific and Technological Research Council of Turkey
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: OTHER
Start Date: 2024-03-01
Completion Date: 2025-03-01
Locations: Asli Kudubeş, Bilecik, Turkey

Summary:
In this project, it was aimed to determine the effect of the rational drug management training program on parents' attitudes towards rational drug use. The project is designed as a randomized controlled study and will consist of experimental and control groups. An education program on rational drug use will be applied to the parents in the experimental group. The originality of this project is the evaluation of the effect of the education program on rational drug use applied to parents whose children are hospitalized. Although studies on rational drug use in parents have increased in recent years, most of them consist of descriptive studies aimed at evaluating knowledge and attitudes towards rational drug use. It seems that the number of intervention studies on rational drug use in parents is limited. No intervention studies aimed at the rational drug use attitudes of parents whose children are hospitalized have been found. This study has the feature of revealing the effectiveness of the rational drug use education program to be applied to parents in cases of illness and hospitalization where the importance of rational drug use becomes evident.

Primary Outcome Measures: Parental Attitude Scale Towards Rational Drug Use mean score, The effect of the applied education on the mean score of the Parental Attitude Scale Towards Rational Drug Use will be evaluated., up to 10 months
RHPRG4 FOR THE TREATMENT OF OCULAR GRAFT-VERSUS-HOST DISEASE (OGVHD)
NCT Number: NCT06495307
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Ocular Graft-versus-host Disease
Interventions: DRUG: rhPRG4
Sponsor: Lubris Bio Pty Ltd
Collaborators: Lubris, LLC|Sydney Eye Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 12
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07
Completion Date: 2025-02-28

Summary:
rhPRG4-GVHD-001 is a prospective multi-center study conducted in Australia to evaluate the safety and efficacy of topically-applied rhPRG4 in subjects with moderate to severe dry eye secondary to chronic GVHD.

Primary Outcome Measures: To assess the efficacy of rhPRG4 using the average VAS score assessing subjects' eye dryness (Question: Rate the dryness of your eye; anchors: 0 = no discomfort, 100 = maximal discomfort) at Day 28, 28|To assess the efficacy of rhPRG4 using the total corneal staining with fluorescein (Oxford Scale) at Day 28, 28|To assess the safety of rhPRG4 by observation of the frequency and severity of treatment-emergent adverse events, 28
Secondary Outcome Measures: To assess the efficacy of rhPRG4 using the average VAS score for foreign body sensation, burning/stinging, itching, pain, sticky feeling, blurred vision and photophobia and total VAS (anchors: not at all & very), 28|To assess the efficacy of rhPRG4 using the maximum inter-eye tear osmolarity: max(OU), 28|To assess the efficacy of rhPRG4 using the absolute difference in inter-eye tear film breakup time (TBUT): min(OU)osmolarity: abs(OD - OS), 28|To assess the efficacy of rhPRG4 using the number of instillations of rescue artificial tear per day, 28|To assess the efficacy of rhPRG4 using a patient questionnaire, 28|To assess the efficacy of rhPRG4 by NIH Eye Score, 28|To assess the safety of rhPRG4 by observation of the Best Corrected Visual Acuity (BCVA), 28|To assess the safety of rhPRG4 by observation of signs evaluated by slit lamp (SLE), 28|To assess the safety of rhPRG4 by observation of intraocular pressure (IOP), 28
Observational Study of Triple Combination Therapy of Zemidapa Tab. and Metformin in Type 2 Diabetes Mellitus Patients
NCT Number: NCT06495281
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Type 2 Diabetes Mellitus
Sponsor: LG Chem
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 3000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-10-26
Completion Date: 2025-12-30
Locations: Chonnam National University Hwasun Hospital, Hwasun, Jeollanam-do, 58128, Korea, Republic of

Summary:
The aim of this study is to evaluate the effectiveness and safety of the triple combination therapy of Zemidapa Tab. and Metformin in patients with type 2 diabete mellitus

Primary Outcome Measures: change from baseline of HbA1c at 12 weeks, baseline, 12 weeks
Secondary Outcome Measures: the rate of subjects who reached the target value of less than 7% HbA1c, 12 weeks
Bioavailability of Human Milk Oligosaccharides in Healthy Adults
NCT Number: NCT06495255
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Healthy
Interventions: DIETARY_SUPPLEMENT: Human Milk Oligosaccharides (HMOs)|DIETARY_SUPPLEMENT: Control
Sponsor: University of Bonn
Collaborators: University Hospital, Bonn
Sex: ALL
Age: ADULT
Enrollment: 10
Study Design: Allocation: RANDOMIZED|Intervention Model: FACTORIAL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-05-14
Completion Date: 2026-03-31
Locations: Rheinische Friedrich-Wilhelms Universität Bonn, Bonn, 53115, Germany

Summary:
Human milk oligosaccharides (HMOs) have been associated with beneficial health outcomes in breastfed infants, therefore they were investigated intensively within recent years. HMOs support the establishment of a "balanced" intestinal microbiome by acting as both a prebiotic and as a specific antimicrobial. In vitro work has demonstrated that HMOs are resistant to hydrolysis by salivary, pancreatic, and brush-border enzymes, as well as to low gastric pH values enzymes. Consequently, HMOs are mostly resistant to digestion and reach the colon unmodified, where they are available for selective utilisation by certain bacteria. Microbial utilisation results in the formation of microbial metabolites, which are associated with local and systemic effects. Simultaneously, HMOs have bacteriostatic effects and directly limit the growth of potential pathogens. Moreover, they serve as antiadhesives, mimicking intestinal epithelial cell surface receptors to which pathogenic microbes attach, thus acting as a decoy receptor. Additionally, it is suggested that HMOs exert effects independent of the microbiome, by modulating cell recognition and cell signalling. These include interactions with immune cells, thereby modulating the development and responses of the immune system, the maturation of the intestinal glycocalyx, and the promotion of neurodevelopment and cognitive functions. A prerequisite for systemic effects is that HMOs are absorbed and can enter the blood circulation, thus making them potentially available at the systemic level. In order to understand the underlying mechanisms for HMO-mediated, microbe-independent effects, information regarding absorption, metabolisation, and excretion is needed and will be investigated in this study.

Primary Outcome Measures: Absorption of HMOs, Concentration of HMOs in blood, through study completion, an average of 1 year|Excretion of HMOs, Concentration of HMOs in urine, through study completion, an average of 1 year
Secondary Outcome Measures: Metabolism, Concentration of metabolic markers in blood, through study completion, an average of 1 year