pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Biomarkers Associated With Temporomandibular Disorders in Patients With Rheumatoid Arthritis
NCT Number: NCT06488937
Status: ACTIVE_NOT_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Temporomandibular Disorders|Rheumatoid Arthritis
Sponsor: Josip Juraj Strossmayer University of Osijek
Collaborators: University of Rijeka Faculty of Dental Medicine
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 92
Study Design: Observational Model: |Time Perspective: p
Start Date: 2019-11-01
Completion Date: 2025-02
Locations: Thalassoterapia Opatija, Specijalna bolnica za medicinsku rehabilitaciju bolesti srca, pluća i reumatizma, Opatija, Rijeka, 51101, Croatia

Summary:
The goal of this observational study is to determinate temeporomandibular disorders (TMDs) and levels of biomarkers in 30 rheumatoid arthritis patients and 30 healthy controls.

Aims are:

* to determine TMDs symptoms in both groups using a validated Reasearch Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD) protocol
* to determine levels of interleukin-4 (IL-4), interleukin-18 (IL-18) and interferon-gamma (IFN-γ) in saliva and serum in RA patients and control group
* to determine levels of biomarkers (Ca, Mg, P, AST,ALT,ALP,GGT,urate) in serum of RA patients and control group
* investigate the correlation between cytokines level in saliva and serum
* to determine the effect of TMDs on cytokine and biomarker levels Participants will be clinicaly examined by DMD in accordance with the RDC/TMD guidelines to receive both Axis I and Axis II diagnoses. After examination participants would be asked for saliva and blood sample.

Primary Outcome Measures: levels of cytokines IL-4, IL-18, IFN-γ in serum, Invitrogen assays will be used for multicomplex quantitative analysis of inflammatory mediators. The entire protocol will be carried out according to the instructions of the manufacturer of Thermofischer Scientific, baseline|levels of cytokines IL-4, IL-18, IFN-γ in saliva, Invitrogen assays will be used for multicomplex quantitative analysis of inflammatory mediators. The entire protocol will be carried out according to the instructions of the manufacturer of Thermofischer Scientific, baseline|levels of calcium (Ca), magnesium (Mg), phosphate (P), uric acid, alanine aminotransferase (ALT), aspartate aminotransferase (AST) and alkaline phosphatase (ALP) and gamma- glutamyltransferase (GGT) in serum, measured up to 6 hours after collection on Roche Cobas c501 biochemistry analyzer, baseline
An Open-label Phase I/II Study of JR-446 in Mucopolysaccharidosis Type IIIB
NCT Number: NCT06488924
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Mucopolysaccharidosis III-B
Interventions: DRUG: JR-446
Sponsor: JCR Pharmaceuticals Co., Ltd.
Sex: ALL
Age: CHILD
Enrollment: 10
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-31
Completion Date: 2029-09-30
Locations: Hiroshima University Hospital, Hiroshima, Japan|University of the Ryukyus Hospital, Okinawa, Japan|National Center for Child Health and Development, Tokyo, Japan

Summary:
A Phase I/ II, open-label study, designed to evaluate the safety and explore efficacy of the study drug in development for the treatment of MPS IIIB patients.

Primary Outcome Measures: To evaluate the tolerability of JR-446 in MPSIIIB patients, Incidence and severity of infusion-associated reactions, including anaphylaxis, up to 4 years (multiple visits)|To explore the potential efficacy of JR-446, Change from baseline in heparan sulfate levels in cerebrospinal fluid (CSF), up to 4 years (multiple visits)
Secondary Outcome Measures: Change from baseline in cognitive function, Bayley Scales of Infant and Toddler Development, Third Edition (BSID-III) and/or Kaufman Assessment Battery for Children, Second Edition (KABC-II), up to 4 years (multiple visits)|Change from baseline in HS concentration in serum and urine, up to 4 years (multiple visits)|Plasma drug concentration, up to 4 years (multiple visits)
To Evaluate Safety and Tolerability of the Fixed- Dose Combination of Obeticholic Acid and Bezafibrate
NCT Number: NCT06488911
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Primary Biliary Cholangitis
Interventions: DRUG: FDC tablet (OCA 5 mg + BZF 400 mg SR)
Sponsor: Intercept Pharmaceuticals
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 133
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07
Completion Date: 2030-03

Summary:
An Open Label Long-Term Study to Evaluate the Safety and Tolerability of the Fixed-Dose Combination (FDC) of Obeticholic Acid (OCA) and Bezafibrate (BZF) tablet in Subjects with Primary Biliary Cholangitis (PBC).

Primary Outcome Measures: Number of participants reporting adverse events (AE) and serious adverse event (SAE), Up to 60 months
Secondary Outcome Measures: Number of participants with 50 percent (%) reduction of pruritus determined by visual analogue scale (VAS) score, The Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10-centimeter (cm) line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be')., Up to 60 months|Number of participants reporting all-cause mortality, Up to 60 months|Number of participants with Adjudicated Liver Related Clinical Outcomes - Liver transplant, Up to 60 months|Number of participants with Adjudicated Liver Related Clinical Outcomes - Progression to hepatic decompensation, Up to 60 months|Number of participants with Adjudicated Liver Related Clinical Outcomes - Model for End-Stage Liver Disease (MELD) Score ≥15, MELD is a scoring system for assessing the severity of chronic liver disease and to assess prognosis and suitability for liver transplantation. It uses the participant's values for total bilirubin, serum creatinine, and the international normalized ratio (INR) for prothrombin time to predict survival. MELD score ranges from 6 (less ill) to 40 (gravely ill) with scores and mortality probability being: Score 40=71.3% mortality; Scores 30-39=52.6% mortality; Scores 20-29=19.6% mortality; Scores 10-19=6.0% mortality; Score 9 or less=1.9% mortality. Higher scores indicated greater disease severity. Adjudication was performed under the review of HSAC of all available data for each identified participant to determine liver injury status., Up to 60 months
Abdominal Aortic Aneurysm Stabilization With Truncal Cells: Controlled Clinical Trial With Historical Cohorts
NCT Number: NCT06488898
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Aortic Aneurysm, Abdominal
Interventions: DRUG: Allogeneic adipose tissue-derived mesenchymal stem cells
Sponsor: Instituto de Investigación Hospital Universitario La Paz
Collaborators: Grupo Dermatologico Y Estetico Pedro Jaen S.A.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 8
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-06-13
Completion Date: 2025-12-31
Locations: Hospital Universitario La Paz, Madrid, 28046, Spain

Summary:
Phase IIa, single-center clinical trial compared with historical cohorts to evaluate the preliminary safety and efficacy of an allogeneic adipose tissue-derived mesenchymal stem cells infusion in an aneurysmal sac for the treatment of AAA.

Primary Outcome Measures: Safety evaluation of the study intervention:, The safety of the treatment will be evaluated using the following parameters:

1. Proportion of procedure-related adverse events occurring throughout the study.
2. Proportion of adverse events related to allogeneic mesenchymal stem cells infusión derived from adipose tissue occurred throughout the study.
3. Proportion of patients with major adverse cerebral and cardiovascular events (MACCE) within 12 months after treatment., 12 months
Secondary Outcome Measures: Efficacy evaluation of the study intervention., Change in size of the aneurysm sac by using imaging tests performed during follow-up (CT and echo Doppler). A reduction of the aneurysm sac maximum diameter greater than or equal to 5mm in a period of 6 months is considered significant., 6 months
Other Outcome Measures: Stent migration in study intervention group vs historical cohort., Percentage of patients with stent migration compared to historical cohort., 12 months|Presence of leaks on CT control in study intervention group vs historical cohort., Percentage of patients with presence of leaks on CT control at 1 month and a year compared to historical cohort., 12 months|Reoperation at 1 year in study intervention group vs historical cohort., Reoperation rate at 1 year compared to historical cohort., 12 months|Hospital admission in study intervention group vs historical cohort., Hospital admission rate compared to historical cohort., 12 months|Quality of life in study intervention group., Assessment of change in quality of life: specific quality of life assessment survey at one month and one year after treatment respect to baseline. A 10% change in quality of life scores is considered clinically relevant., 12 months
Innovative Administration of Long-Acting Injectables for HIV Treatment Enhancement at Home
NCT Number: NCT06488846
Acronym: INVITE-Home
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: HIV Infections
Interventions: OTHER: INVITE-Home
Sponsor: University of California, San Francisco
Collaborators: Centers for Disease Control and Prevention
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-05-31
Completion Date: 2027-09-29
Locations: Division of Prevention Science, Center for AIDS Prevention Studies (CAPS), San Francisco, California, 94143, United States

Summary:
This study will support the expansion of long-acting injectable antiretroviral therapy (LAI-ART) in non-clinical settings by developing, implementing, and evaluating a comprehensive, theory-informed training intervention to support the administration of LAI-ART by a trained layperson injector (e.g., friend, family, partner identified by a person living with HIV). This study will address barriers to LAI-ART uptake and persistence, enhance real-world effectiveness, and help close critical HIV care gaps.

Primary Outcome Measures: Feasibility of Home-Based LAI-ART Administration, To assess Feasibility, HIV clinicians will complete the Feasibility of Intervention Measure. Possible scores on the Feasibility of Intervention Measure range from 4 (less feasible) to 20 (very feasible).

Weiner BJ, Lewis CC, Stanick C, et al. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017;12(1):108. Published 2017 Aug 29. doi:10.1186/s13012-017-0635-3, 12 months|Acceptability of Home-Based LAI-ART Administration, To assess Acceptability, People With HIV and their chosen Treatment Buddy will complete two measures:

1. Injection-Treatment Acceptance Questionnaire: Possible scores on the measure range from 0 (very unacceptable) to 120 (very acceptable).

   Tatlock S, Arbuckle R, Sanchez R, Grant L, Khan I, Manvelian G, Spertus JA. Psychometric Evaluation of a Treatment Acceptance Measure for Use in Patients Receiving Treatment via Subcutaneous Injection. Value Health. 2017 Mar;20(3):430-440. doi: 10.1016/j.jval.2016.09.2410. Epub 2016 Dec 1. PMID: 28292488.
2. Acceptability of Intervention Measure: Possible scores on the measure range from 4 (less acceptable) to 20 (very acceptable).

Weiner BJ, Lewis CC, Stanick C, et al. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017;12(1):108. Published 2017 Aug 29. doi:10.1186/s13012-017-0635-3, 12 months|HIV viral suppression defined as two suppressed viral load test (HIV-RNA-PCR) results at least three months apart., The investigators will assess viral suppression with two suppressed viral load test results at least three months apart within a 12-month period. A suppressed result is considered less than 200 copies/mL., 12 months
Safety and Efficacy of Pulsed-field Ablation for Atrial Fibrillation in High Versus Low-volume Ablation Centers (SAFFICIENT)
NCT Number: NCT06488820
Acronym: SAFFICIENT
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Atrial Fibrillation
Interventions: DEVICE: Catheter ablation using pulsed-field ablation (PFA) system
Sponsor: Texas Cardiac Arrhythmia Research Foundation
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 2276
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08
Completion Date: 2027-08

Summary:
Catheter ablation using radiofrequency (RF) energy has been widely adopted for management of atrial fibrillation (AF) for the past several years.

However, heterogeneity of outcomes and complication rates are still reported that have been partly attributed to operator's experience and center's procedure volume (1). In a meta-analysis of 14 studies, both hospital volume of ≥50 and ≥100 procedures per year were associated with significantly lower complication rate compared to \<50/year (2).

Pulse-field ablation (PFA) is an emerging technology for AF management that has demonstrated tremendous potential in terms of preferential tissue ablation with no damage to the adjacent organs. In the MANIFEST-PF survey, 24 European centers participated that had a mean of 704 ablations per year with 73.3 (range 7-291) PFA ablations annually (3). No post-PFA esophageal complications, PV stenosis or persistent phrenic nerve injury were reported. There appeared to be a trend toward fewer complications with center experience, particularly for pericardial tamponade (3).

However, the impact of number of PFA performed on procedure-success and safety has not been evaluated in the US.

This multicenter prospective study is designed to compare the incidence of adverse event (AE) and long-term procedural success of pulse-field ablation for AF in low volume (\<100/year) vs. high volume (≥100/year) centers.

Primary Outcome Measures: Safety of PFA, Adverse events, 1 year
Secondary Outcome Measures: Efficacy of PFA, Arrhythmia-free on- or off-antiarrhythmic drugs, 2-mo blanking period+ 11 months
The Efficacy of 3% Kanuka Oil Versus 1% Hydrocortisone Cream in Patients With Atopic Dermatitis
NCT Number: NCT06488742
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Dermatitis, Atopic|Pruritus
Interventions: OTHER: 3% kanuka oil
Sponsor: Nexgen Dermatologics, Inc.
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2023-11-01
Completion Date: 2025-03-20
Locations: Berlin Center, Boynton Beach, Florida, 33437, United States

Summary:
Atopic dermatitis is a common disease affecting millions worldwide. A common associated symptom in this population is pruritus. We seek to investigate the use of an natural, over-the-counter cosmeceutical to help this population

Primary Outcome Measures: ISGA, Investigator scale to determine imporvement in condition, 28 days|WI-NRS, Scale generated by patient's responses to survey questions to assess improvement in itch, 28 days
Foot Massage Applied Before a Bronchoscopy Procedure on Physiological Parameters and Anxiety
NCT Number: NCT06488729
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Physiological Parameters|Anxiety|Bronchoscopy
Interventions: OTHER: Foot massage
Sponsor: Saglik Bilimleri Universitesi
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2022-08-01
Completion Date: 2023-02-04
Locations: University of Health Sciences Turkey, İstanbul, Üsküdar, Turkey

Summary:
The goal of this randomized controlled trial is to assess the effectiveness of foot massage on physiological parameters and anxiety in patients undergoing bronchoscopy. The main questions it aims to answer are:

* Does foot massage applied before bronchoscopy affect physiological parameters?
* Does foot massage before bronchoscopy affect anxiety? Patients in the intervention group received foot massage once before bronchoscopy. Patients in the control group did not receive any treatment other than routine care.

Primary Outcome Measures: physiological parameters, systolic blood pressure (mmHg), The data of the groups were collected during the first arrival of the individuals (before the massage), 40 minutes after the first measurement (after the massage), and following bronchoscopy.|physiological parameters, diastolic blood pressure (mmHg), The data of the groups were collected during the first arrival of the individuals (before the massage), 40 minutes after the first measurement (after the massage), and following bronchoscopy.|physiological parameters, heart rate (beats per minute (min-1 or bpm), The data of the groups were collected during the first arrival of the individuals (before the massage), 40 minutes after the first measurement (after the massage), and following bronchoscopy.|physiological parameters, respiratory rate (per minute), The data of the groups were collected during the first arrival of the individuals (before the massage), 40 minutes after the first measurement (after the massage), and following bronchoscopy.|physiological parameters, oxygen saturation (percent (%)), The data of the groups were collected during the first arrival of the individuals (before the massage), 40 minutes after the first measurement (after the massage), and following bronchoscopy.|anxiety, The State Anxiety Inventory, The data of the groups were collected during the first arrival of the individuals (before the massage), 40 minutes after the first measurement (after the massage), and following bronchoscopy.
A Study to Evaluate the Safety, Pharmacokinetics, and Activity of RO7759065 as a Single Agent and in Combination With Atezolizumab in Patients With Locally Advanced or Metastatic Solid Tumors
NCT Number: NCT06488716
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Solid Tumour
Interventions: DRUG: RO7759065|DRUG: Atezolizumab
Sponsor: Genentech, Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 310
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-15
Completion Date: 2027-02-28
Locations: City of Hope Comprehensive Cancer Center, Duarte, California, 91010, United States

Summary:
This is a first-in-human Phase Ia/Ib, open-label, multicenter, dose escalation and dose expansion study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary anti-tumor activity of RO7759065 as a single agent (Phase Ia) or in combination with atezolizumab (Phase Ib) in patients with locally advanced, recurrent, or metastatic incurable solid tumor malignancies. Several key aspects of the study design and study population are summarized below.

Primary Outcome Measures: Number of Participants iwth Dose Limiting Toxicity (DLTs), Up to approximately 5 years|Number of Participants with Adverse Events (AEs), Up to approximately 5 years
Secondary Outcome Measures: Maximum Serum Concentration (Cmax) of RO7759065, Up to approximately 5 years|Objective Response Rate (ORR), Up to Approximately 5 Years|Duration of Response (DOR), Up to approximately 5 years|Progression Free Survival (PFS), Up to approximately 5 years|Percentage of Participants With Anti-Drug Antibodies (ADAs) to RO7759065, Up to approximately 5 years
Early Warning Scores in Pregnant Woman
NCT Number: NCT06488690
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Pregnancy Complications
Interventions: OTHER: All patients who were pregnant and underwent cesarean section
Sponsor: Suleyman Demirel University
Sex: FEMALE
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 304
Study Design: Allocation: NA|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2022-04-01
Completion Date: 2024-02-01
Locations: Suleyman Demirel University, Isparta, Merkez, 32200, Turkey

Summary:
Our study aims to evaluate the use of early warning scores as a screening tool to predict obstetric mortality and morbidity in pregnant women who will undergo cesarean section.

Primary Outcome Measures: MEOWS, MEWC and MEWT scores, The presence of a "trigger" for MEOWS in all systems, defined as either a single severely abnormal parameter (falling in the "red" zone) or two slightly abnormal parameters (falling in the "yellow" zone), was categorized as the risky group. Absence or mildness of the trigger was considered as the risk-free group., One year|MEWC score, In the case of MEWC, the presence of only one abnormal parameter designated the risk group, while the absence of a trigger indicated the risk-free group., One year|MEWT score, For MEWT, the presence of a "trigger" defined as either a single severely abnormal parameter (falling in the "red" zone) or two mildly abnormal parameters (falling in the "yellow" zone) was categorized as the risky group, with the absence or mildness of the trigger considered as the risk-free group., One year
Secondary Outcome Measures: APGAR score, APGAR scores at 1st and 5th minutes were calculated for postnatal babies., One year|Aldrete score, The Modified Aldrete Recovery Score System was computed for mothers to assess postoperative recovery., One year|Glasgow Coma Scale, The Glasgow Coma Scale (GCS) was used to evaluate the consciousness of pregnant women., One year
Influence of Social Determinants on Lifestyle Modification Adherence in People With Prediabetes
NCT Number: NCT06488677
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: PreDiabetes
Interventions: BEHAVIORAL: Lifestyle changes (diet and physical activity)
Sponsor: University of the Balearic Islands
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-30
Completion Date: 2024-12-30
Locations: University of the Balearic Islands, Palma De Mallorca, Balearic Islands, 07122, Spain

Summary:
A sequential explanatory mixed-methods study analyzing the influence of social determinants on adherence to healthy lifestyle recommendations in individuals with prediabetes.

Primary Outcome Measures: Adherence to healthy lifestyle recommendations, Adherence to healthy lifestyle recommendations measured through a composite index generated with data from 1) dietary adherence assessed using the 14-item PREDIMED Mediterranean Diet questionnaire and 2) physical activity adherence evaluated using the REGICOR Abbreviated Questionnaire., at month 9 of the intervention period|Facilitators and barriers to adherence to lifestyle changes, Facilitators and barriers to adherence to lifestyle changes such as social and family support, knowledge about one's health condition, health beliefs, and the patient-professional relationship, at month 9 of the intervention period
Efficacy and Safety of Oral Controlled-Ileocolonic-Release Nicotinamide (CICR-NAM)
NCT Number: NCT06488625
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2|PHASE3
Conditions: Ulcerative Colitis, Unspecified
Interventions: DRUG: Low-Dose CICR-NAM|DRUG: High-Dose CICR-NAM|DRUG: 0 g/d CICR-NAM (blinded)|DRUG: Open-Label
Sponsor: University Hospital Schleswig-Holstein
Collaborators: Ced Service GmbH|Gesellschaft für Therapieforschung mbH|German Federal Ministry of Education and Research
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 459
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-21
Completion Date: 2027-12

Summary:
Double-blind, randomised, placebo-controlled phase II / III trial evaluating efficacy and safety of two different doses (2 g/d or 3 g/d) of oral controlled-ileocolonic-release nicotinamide (CICR-NAM) compared to placebo in patients with ulcerative colitis (UC).

The intended therapeutic use of CICR-NAM is to improve intestinal inflammation in adults with UC by topically increasing nicotinamide supply in the ileocolonic region and thus favourably influencing the composition of intestinal microbiota

Primary Outcome Measures: Symptomatic remission, The proportion of subjects that show symptomatic remission. Symptomatic remission is achieved if: Mayo SF = 0 or 1 (and SF no greater than baseline) and Mayo RB = 0 as well as a reduction from Mayo ES = 2 or 3 at baseline by at least one point or a reduction from Mayo ES = 1 at baseline to Mayo ES = 0 or, in case of a constant Mayo ES = 1 from baseline, an objective second marker of improvement (histologic improvement to RHI ≤ 4), Baseline - Week 12|Clinical remission, The proportion of subjects that show clincial remission. Clinical remission is achieved if: Mayo SF = 0 (or SF = 1 with a ≥ 1-point decrease from baseline), Mayo RB = 0, and Mayo ES ≤ 1 (excluding friability) (for constant Mayo ES = 1 from baseline, histologic improvement to RHI ≤ 4), Baseline - Week 52
Evaluation of the Use of Minced Skin Grafts for Promoting Donor Site Wound Healing After Split-Thickness Skin Grafting
NCT Number: NCT06488612
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Traumatic Skin Loss, 2nd and 3rd Degree Burn, Post Tumour Excision - Raw Areas Undergoes Split- Thickness Skin Grafts
Interventions: PROCEDURE: Minced skin grafts for donor site
Sponsor: Sohag University
Sex: ALL
Age: CHILD, ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2023-12-01
Completion Date: 2024-12-01
Locations: Plastic surgery department, Faculty of medicine, Sohag university, Sohag, 02093, Egypt

Summary:
Split-thickness skin grafting (STSG) is one of the most commonly performed procedures to achieve wound closure. Most studies are concerned on improving the appearance of scars and shortening the healing time of the recipient sites. However, the management of the donor site usually takes a second consideration.

There is a lack of consensus on the recommended method of donor site management. Donor site morbidity of STSG is usually minimal, but that may not always be the case. Morbidity may include pigmentary abnormalities, prolonged pain and itching, delayed healing, or unfavorable scarring. So, an effort must be taken to find the optimal solution for donor site healing and minimize morbidity.

Small portions of the skin graft left at the end of the procedure or the graft pieces obtained after trimming the edges are usually discarded. There have been some studies demonstrating the benefit of the minced residual skin graft on the donor site, possibly resulting in earlier epithelialization and improving the appearance

Primary Outcome Measures: Scar quality, using POSAS scale.

• Patient Observer Scar Assesment Scale (POSAS) is a validated scale that measures scar quality by evaluating visual, tactile, and sensory characteristics of the scar from two different perspectives: the patient perspective and the surgeons' perspective., Follow up at 1 month, 3 months, 6 months
Marginal Bone Loss Around Mandibular Implant-retaining Overdentures and Implant Supported Fixed Hybrid Prosthesis
NCT Number: NCT06488599
Status: ENROLLING_BY_INVITATION
Study Type: OBSERVATIONAL
Conditions: Bone Loss in Jaw|Dental Implant Failure Nos|Dental Implant Failed
Interventions: RADIATION: Peri-apical radiographs on the implants
Sponsor: Saint-Joseph University
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 19
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-12-15
Completion Date: 2024-07-20
Locations: Saint Joseph University of beirut, Beirut, 00000, Lebanon

Summary:
Few if any studies have compared marginal bone loss (MBL) around implant-retaining overdentures (2 implants with locators) versus implant supported fixed hybrid prosthesis (over 4 implants) in the mandible.

Primary Outcome Measures: Marginal Bone Loss in mm (MBL), MBL in mm around implants in patients having a removable prosthesis over locators and in patients having a screw retained hybrid prosthesis, 5 years
Secondary Outcome Measures: smoking status, non smoker, smoker less than 10 cig/day, smoker more than 10 cig/day, 5 years|compliance and attendance to recall sessions, patient attending the recall sessions or no, 5 years|keratinized tissue hight, measured in mm with a periodontal probe, 5 years|framework design, prosthetic framework fit/misfit, 5 years|age, in years, 5 years|health status, diabetes yes/no ; cardiovascular disease yes/no, 5 years|sex, male female, 5 years|plaque score, using the modified plaque index (0 absence,1 detectable by a probe, 2 visible, 3 abundant), 5 years
IV Ketamine Vs. in Esketamine for MDD TRD
NCT Number: NCT06488586
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Treatment Resistant Depression
Sponsor: Gustavo Vazquez
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-03-20
Completion Date: 2026-10-20

Summary:
The goal of this observational study is to learn about the comparative acute effects of ketamine vs esketamine in participants over the age of 18 for the treatment of their severe depression and suicidal ideations.

Participants are already taking antidepressants and/or antipsychotics as part of their regular medical care for depression,

Primary Outcome Measures: Montgomery-Åsberg Depression Rating Scale (MADRS), The Montgomery-Åsberg Depression Rating Scale (MADRS) is a ten-item diagnostic questionnaire which mental health professionals use to measure the severity of depressive episodes in patients with mood disorders., From enrollment to the end of treatment at 4 weeks
Secondary Outcome Measures: Montgomery-Åsberg Depression Rating Scale (MADRS) item 10, The Montgomery-Åsberg Depression Rating Scale (MADRS) item 10 is one of the ten-items of this specific questionnaire that assess suicidal thoughts among individuals with depressive episodes (MDD), From enrollment to the end of treatment at 4 weeks
A Safety and Pharmacokinetics Study of Complarate (Tocilizumab Biosimilar Solution) and Actemra® in Healthy Volunteers
NCT Number: NCT06488521
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Healthy Volunteers
Interventions: BIOLOGICAL: Complarate|BIOLOGICAL: Actemra®
Sponsor: AO GENERIUM
Sex: ALL
Age: ADULT
Enrollment: 256
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: OTHER
Start Date: 2024-06-20
Completion Date: 2024-12-12
Locations: State budgetary healthcare institution of the city of Moscow "City Clinic No. 2 of the Moscow Health Department", Moscow, 117556, Russian Federation|Federal State Autonomous Educational Institution of Higher Education First Moscow State Medical University named after I.M. Sechenov Ministry of Health of Russia, Moscow, 119435, Russian Federation|LLC "X Seven Clinical Research", Saint Petersburg, 194156, Russian Federation

Summary:
This is a randomized single-blind comparative parallel group study of the safety, pharmacokinetics of the solution form of Complarate and Actemra® in healthy volunteers. Participants received a single subcutaneous dose of tocilizumab 162 mg. The follow up period was 43 days.

Primary Outcome Measures: Pharmacokinetics: Area under the plasma concentration versus time curve (AUC), Analysis of equivalence of area under concentration-time curve from time 0 (predose) to the last quantifiable data point and to infinity of Complarate and Actemra®, Day 43|Pharmacokinetics: Peak Plasma Concentration (Cmax), Analysis of equivalence of Cmax of Complarate and Actemra®, Day 43
Secondary Outcome Measures: Proportion of volunteers with adverse events (AE), The Investigator will carefully monitor each subject throughout the study for any adverse events (coded to preferred term and system organ class using the Medical Dictionary for Regulatory Activities \[MedDRA\]), Day 43|Proportion of volunteers with ADA, Antidrug antibodies (ADA) level, Day 43
Psychometric Properties of the Therapy-Related Symptom Checklist-Children
NCT Number: NCT06488456
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Pediatric Leukemia, Acute Myeloid|Pediatric ALL
Interventions: OTHER: TRSC-C
Sponsor: Ege University
Sex: ALL
Age: CHILD, ADULT
Enrollment: 210
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-04-01
Completion Date: 2025-06-01
Locations: Ege University, İzmir, 35100, Turkey

Summary:
Diagnosis and treatment of childhood cancers is an exhausting process that affects both children and their caring parents physically and mentally. While the survival rate in childhood cancers was 28% in the 1960s, this rate has increased up to 80% with the developments in treatment methods. Although the main methods used in cancer treatment today are surgical treatment, radiotherapy, and immunotherapy, the main component of cancer treatment is chemotherapy. Improvements in chemotherapy protocols have increased survival; however, the use of high-dose chemotherapy may increase the frequency and severity of symptoms that may be seen in children. Therefore, diagnosis and management of treatment-related symptoms in the pediatric population receiving chemotherapy treatment as soon as possible is of vital importance as it will significantly affect the quality of life of children. In this context, this study aimed to add to the national literature by conducting a Turkish validity and reliability study of a checklist suitable for the use of health professionals in clinics for monitoring the side effects of chemotherapy. In the study, validity and reliability tests will be performed for intercultural scale adaptation.

Primary Outcome Measures: Turkish version of the scale, Use of the Turkish version of the Theraphy Related Symptom Checklist. Min: 0, Max: 120 points The higher the score, the worse the symptoms., April 2022-December 2024
Secondary Outcome Measures: frequency of symptoms, frequency of symptoms related to chemotherapy treatment, April 2022-December 2024|symptom severity, symptom severity due to chemotherapy treatment, April 2022-December 2024
Implementation Science to Improve School Ethos for Mental Health
NCT Number: NCT06488404
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Mental Health Issue
Sponsor: University of Pittsburgh
Collaborators: Fogarty International Center of the National Institute of Health|Schizophrenia Research Foundation (SCARF India), Chennai, India
Sex: ALL
Age: CHILD, ADULT
Enrollment: 50
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-01
Completion Date: 2025-06-30
Locations: Schizophrenia Research Foundation (SCARF India), Chennai, Tamilnadu, 600101., India

Summary:
The objective of the study is to identify the challenges and opportunities existing within the school ethos in implementing evidence-based interventions to improve youth mental health and to identify the most appropriate implementation strategies for improving mental health among young people in schools at Chennai, a city in Southern part of India, a low- and middle- income country setting.

Primary Outcome Measures: School ethos, Understanding the school ethos towards mental health prevailing in the schools from urban settings using in-depth interviews, for six months|Challenges and bariers, Making a list of the challenges and opportunities in establishing and implementing a positive school ethos towards mental health in the schools using in-depth interviews, For six months
The Impact of Respiratory Training of DIBH Radiotherapy for Breast Cancer
NCT Number: NCT06488391
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Breast Cancer
Interventions: BEHAVIORAL: Using a Portable Visualized Device for Self-Directed Breathing Training
Sponsor: Jianjun Lai
Sex: FEMALE
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-01
Completion Date: 2026-07-15
Locations: Zhejiang Hospital, Hangzhou, Zhejiang, China

Summary:
Breast cancer DIBH (Deep Inspiration Breath Hold) radiotherapy represents a high-precision treatment approach that substantially minimizes radiation exposure to vital organs such as the heart, thus enhancing protection of the patient's heart, lungs, contralateral breast, and other normal tissues compared to conventional radiotherapy techniques. This method requires meticulous precision, necessitating that patients possess exceptional respiratory control, which is facilitated through specialized equipment. Without such control, patients may encounter issues like missed targets, significant setup errors, and extended treatment durations.

In this study, the research team employed portable devices to enable patients to independently perform daily respiratory training exercises. The control group received no such devices; instead, these patients were merely instructed verbally on the importance of improving their breath-holding capabilities. The effectiveness of this intervention was evaluated by comparing the daily setup errors between the two groups. Additionally, the intervention's influence on patient outcomes was assessed by monitoring the toxicity and side effects experienced by the patients.

Primary Outcome Measures: The daily measured setup error values of the image-guided radiotherapy device during the patient's treatment process., Statistical comparison and analysis of daily setup error values in patients are used to evaluate the effectiveness of the intervention measures., 5 weeks
Phase Ib Study of Axatilimab in Combination with Olaparib in BRCA1/2 and PALB2- Associated Metastatic HER2-negative Breast Cancer
NCT Number: NCT06488378
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Breast Cancer|PALB2-Mutated Breast Carcinoma|HER2-negative Breast Cancer|BRCA1 Mutation|BRCA2 Mutation
Sponsor: Dana-Farber Cancer Institute
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-13
Completion Date: 2029-03-01

Summary:
This research is being done to evaluate the safety and tolerability of the new drug, axatilimab, in combination with olaparib (a standard of care treatment) in Breast Cancer 1/2 genes (BRCA 1/2) and PALB2 associated HER2-negative metastatic breast cancer.

The names of the study drugs involved in this study are:

* Axatilimab (a type of antibody)
* Olaparib (a type of PARP inhibitor)

Primary Outcome Measures: Maximum Tolerated Dose (MTD), MTD is determined by Bayesian optimal interval (BOIN) design, where the target toxicity rate for the MTD is 0.25 and the maximum sample size is 20., Up to 4 weeks|Recommended Phase 2 Dose (RP2D), If the MTD is identified as 3mg/kg, we will complete enrollment of 10 pts at the 1 mg/kg dose level, to determine if there is biological effectiveness (and clinical efficacy) at the lower dose level., Up to 4 weeks
Secondary Outcome Measures: Objective Response Rate (ORR), ORR was defined as the percentage of participants achieving complete response (CR) or partial response (PR) on treatment based on RECIST 1.1 criteria. Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions., Up to 6 months|Median Progression Free Survival (PFS), PFS based on Kaplan-Meier method is defined as the time from registration to the earlier of progression (per RECIST 1.1) or death due to any cause. Participants alive without disease progression are censored at data of last disease evaluation. Deaths that occur within the time frame of the disease assessment period will count towards the PFS estimate. Deaths that occur outside of this assessment period will be censored at date of last disease evaluation., Up to 6 months
In Vivo Liquid Biopsy of Melanoma (Cytophone)
NCT Number: NCT06488365
Acronym: Cytophone
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Melanoma|Circulating Tumor Cells|Metastatic Melanoma|Diagnosis
Interventions: DEVICE: Cytophone
Sponsor: Cytoastra
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 180
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-09-01
Completion Date: 2025-07-20

Summary:
The Cytophone is a first in the world patented system to identify and count single circulating melanoma cells in blood circulation inside the human body. The Cytophone has a unique capability to find rare melanoma cells in the blood by an assessment of 100-500 times greater amounts of blood volume than routine blood tests. The important benefit of the Cytophone diagnosis is that the test does not require injection or any skin incision (i.e., non-invasiveness). The goal of this clinical trial is to demonstrate evidence of the capability of the Cytophone test to indicate a risk of metastasis and define CTC counts that correlate with melanoma recurrence, progression of metastatic disease, and therapy efficacy. The investigators believe that clinical trials will provide evidence that the Cytophone can diagnose risk of melanoma metastasis and recurrence earlier than existing methods.

Primary Outcome Measures: Identify and count CTCs in blood in vivo, Link CTC counts with early melanoma progression and recurrence efficacy, nine months
Enhancing Care Study in Patients After CABG
NCT Number: NCT06488352
Acronym: OptiCABG
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Coronary Artery Bypass
Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2013-01-01
Completion Date: 2026-06-30
Locations: Structral Heart Disease Center, Fuwai Hospital, Beijing, Beijing, China

Summary:
Review the data of patients who underwent coronary artery bypass grafting (CABG) at the National Center for Cardiovascular Disease, Fuwai Hospital from January 2013 to June 2023 including medical history, head CT scan, and postoperative, including 30-day mortality, arrhythmia, cerebrovascular disease and intracerebral haemorrhage, etc. Case-control and retrospective cohort studies were conducted to explore the risk factors associated with early postoperative complications, examine their relationship with postoperative management, explore independent risk factors of compound complications, and build predictive models.

Primary Outcome Measures: 30-day mortality, The proportion of patients who die within 30 days of being admitted to the hospital., 30 days
Secondary Outcome Measures: post-operative atrial fibrillation, The occurrence of atrial fibrillation after a patient has undergone surgery., Around the second postoperative day.|MACE, A combination of several critical cardiovascular events may vary depending on the specific context of the study or clinical evaluation., Around the second postoperative day.
Food Replacement on Weight Control in Overweight Volunteers
NCT Number: NCT06488339
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Weight Gain
Interventions: DIETARY_SUPPLEMENT: Protein and oil supplement
Sponsor: Chulalongkorn University
Collaborators: Mae Fah Luang University
Sex: ALL
Age: ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-07-15
Completion Date: 2025-05-15

Summary:
Volunteers will be divided into two groups which are protein and oil supplement group and normal dietary group. For protein and oil supplement group, they will take 1 sachet of product replaced dinner every day for 8 weeks. For normal dietary group, they will take regular dinner every day for 8 weeks. Weight, body mass index, body composition, waist and hip circumference, skin fold thickness, and chemistry in blood will be evaluated.

Primary Outcome Measures: Weight, Weight of volunteers (kg), 8 weeks
Secondary Outcome Measures: Body mass index, Body mass index of volunteers (kg/m2), 8 weeks|Percentage of body fat, Percentage of body fat (%) using bioelectrical impedance analysis (BIA), 8 weeks|Percentage of visceral fat, Percentage of visceral fat (%) using bioelectrical impedance analysis (BIA), 8 weeks|Percentage of subcutaneous fat, Percentage of subcutaneous fat (%) using bioelectrical impedance analysis (BIA), 8 weeks|Percentage of muscle, Percentage of muscle (%) using bioelectrical impedance analysis (BIA), 8 weeks|Waist Circumference, Waist Circumference (cm), 8 weeks|Hip Circumference, Hip Circumference (cm), 8 weeks|Skin fold thickness, Skin fold thickness (mm) using Skinfold Caliper, 8 weeks|Total cholesterol, Blood total cholesterol (mg/dL), 8 weeks|Low density lipoprotein, Low density lipoprotein (mg/dL) in blood, 8 weeks|High density lipoprotein, High density lipoprotein (mg/dL) in blood, 8 weeks|Triglycerides, Triglycerides (mg/dL) in blood, 8 weeks|Fasting blood sugar, Fasting blood sugar (mg/dL) in blood, 8 weeks|Hemoglobin A1C, Hemoglobin A1C (%) in blood, 8 weeks|Total protein, Total protein (g/dL) in blood, 8 weeks|Hemoglobin, Hemoglobin (g/dL) in blood, 8 weeks|SIRT1 (NAD-dependent deacetylase sirtuin-1), SIRT1 (NAD-dependent deacetylase sirtuin-1) (%) in blood, 8 weeks|8-hydroxy-2-deoxyguanosine, 8-hydroxy-2-deoxyguanosine (%) in blood, 8 weeks|Blood urea nitrogen, Blood urea nitrogen (mg/dL) in blood, 8 weeks|Creatinine, Creatinine (mg/dL) in blood, 8 weeks|Aspartate transaminase, Aspartate transaminase (U/L) in blood, 8 weeks|Alanine aminotransferase, Alanine aminotransferase (U/L) in blood, 8 weeks|Alkaline phosphatase, Alkaline phosphatase (U/L) in blood, 8 weeks
Mulberry Leaf Extract Capsule on Blood Glucose Control in Healthy Volunteers
NCT Number: NCT06488326
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Health, Subjective
Interventions: DRUG: Mulberry leaf extract 6 mg capsule|DRUG: Mulberry leaf extract 12 mg capsule|DRUG: Mulberry leaf extract 18 mg capsule|DRUG: Placebo capsule
Sponsor: Chulalongkorn University
Collaborators: Mae Fah Luang University
Sex: ALL
Age: ADULT
Enrollment: 56
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: SCREENING
Start Date: 2024-07-01
Completion Date: 2025-02-25

Summary:
Volunteers will be divided into 4 groups which are mulberry leaf extract 6 mg capsule, mulberry leaf extract 12 mg capsule, mulberry leaf extract 18 mg capsule, and placebo capsule group. They will be tested blood glucose levels (taken from the fingertips) before starting. Then, they will take 1 capsule of the sample one time. After taking the sample for 30 minutes, they will take 50 g of sucrose in 250 ml of water in 5 minutes. Then, they will be tested blood glucose levels (taken from the fingertips) at 30, 60, 90, and 120 minutes.

Primary Outcome Measures: Blood glucose, Volunteers will be measured the blood glucose using blood glucose meter and strip (accuchek) before and after taking the sample for 30, 60, 90, and 120 minutes., 120 minutes