pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Dapagliflozin on Renal Morphology and Renal Perfusion in Patients One Year After Kidney Transplantation
NCT Number: NCT06560801
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Chronic Kidney Diseases
Interventions: DRUG: Dapagliflozin 10mg Tab
Sponsor: University of Erlangen-Nürnberg Medical School
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 48
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-07-28
Completion Date: 2026-12-31
Locations: Clinical Research Center (CRC), Erlangen, Bavaria, 91054, Germany

Summary:
The aim of this study is to observe the mechanisms of dapagliflozin on the renal interstitial tissue and renal perfusion. For this purpose, renal transplanted patients as an excellent model of CKD and high cardiovascular risk (similar to patients in DAPA-CKD study) are included in this study.

The objectives of the study are to analyze the effects of dapagliflozin on renal morphology and renal perfusion in patients with impaired renal function one year after kidney transplantation. This is a randomized (1:1), single centre clinical study. Each patient will be randomly assigned in an unblinded fashion to 10 mg Dapagliflozin or not 9 months after transplantation. At least 48 patients will be randomized and included. The routine renal biopsy taken one year after kidney transplantation will allow us to determine the morphological integrity of peritubular fibroblasts, interstitial inflammatory cell density and investigate markers of inflammation, oxidative stress and nitic oxide synthase expression (iNOS).

Primary Outcome Measures: renal morphology - fibroblasts, integrity of peritubular fibroblasts (PDGFRα) assessed from the routine one year follow up biopsy of the renal transplant, 3 months after randomization|renal morphology - inflammation, markers of inflammation (example CD3, CD68, CD163) in the interstitium from the routine one year follow up biopsy of the renal transplant, 3 months after randomization|renal morphology - oxidative stress, markers of oxidative stress (Nox1, 8-OHdG) in the interstitium assessed from the routine one year follow up biopsy of the renal transplant, 3 months after randomization
Secondary Outcome Measures: mRNA Expression profile of transcripts, mRNA Expression profile of transcripts relevant in renal transplantation using the Human Organ Transplant Panel of NanoString including 770 genes., 3 months after randomization|renal perfusion, renal perfusion of the renal transplant measured by ASL-MRI, 3 months after randomization|central (aortic) systolic pressurepulse pressure, central (aortic) systolic pressure and pulse pressure, 3 months after randomization|pulse pressure, pulse pressure, 3 months after randomization
Effects of Nigella Sativa on T Cells and Cytokine Profile in Pediatric SLE Patients
NCT Number: NCT06560775
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: SLE (Systemic Lupus)
Interventions: COMBINATION_PRODUCT: Standard Treatment for SLE
Sponsor: University of Brawijaya
Sex: ALL
Age: CHILD, ADULT
Enrollment: 32
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2022-01-03
Completion Date: 2023-01-03
Locations: Universitas Brawijaya, Malang, East Java, 65145, Indonesia

Summary:
The goal of this clinical trial is to learn if Nigella sativa oil works to improve SLEDAI Score in SLE pediatric student. It will also learn about the Treg, T helper cells, and cytokine of the patient. The main questions it aims to answer are:

Does Nigella sativa oil lower the SLEDAI Score in pediatric patient? How does the effects of Nigella sativa oil on Treg cells, T helper cells, and cytokine in pediatric patient? Researchers will compare Nigella sativa oil group to a placebo group (a look-alike substance that contains no drug) to see if Nigella sativa oil works to treat SLE in pediatric patients.

Participants will:

Visit the clinic once in the beginning for pre treatment checkups. Take Nigella sativa oil or a placebo every day for 8 weeks. Visit the clinic once every 4 weeks for checkups. Visit the clinic after 8 weeks for post treatment checkups.

Primary Outcome Measures: T cell lymphocyte and cytokine profiles, as well as SLEDAI Score, T cell lymphocyte includes Th1, Th2, Th17, and Treg in pg/mL (picograms per millilitre).

Cytokine profiles includes IFN-γ, TNF-α, IL-2, IL-4, IL-6, IL-10, and IL-17α in pg/mL (picograms per millilitre).

SLEDAI Score: SLE Disease Activity Index 2000 (SLEDAI-2K) in the point range between 0-105 (the higher the score the higher the disease activity). No activity (SLEDAI=0), mild activity (SLEDAI=1 to 5), moderate activity (SLEDAI=6 to 10), high activity (SLEDAI=11 to 19), and very high activity (SLEDAI≥20).

T-cell lymphocytes and cytokine profiles will be used to determine the immunomodulating effect of Nigella sativa oil on the change of disease activity through the SLEDAI Score of paediatric SLE patients., up to 4 months
Study in Participants With Heart Failure With Preserved Ejection Fraction (HFpEF)
NCT Number: NCT06560762
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Heart Failure With Preserved Ejection Fraction (HFpEF)
Interventions: DRUG: STM01
Sponsor: Secretome Therapeutics
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 18
Study Design: Allocation: NA|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-15
Completion Date: 2025-10-15
Locations: Northwestern Medicine, Chicago, Illinois, 60611-5969, United States|UT Southwestern Medical Center, Dallas, Texas, 75390, United States

Summary:
A Phase 1, Open label, Multiple Ascending Dose Study to Assess Safety and Tolerability of STM-01 in Participants with Heart Failure with Preserved Ejection Fraction (HFpEF)

Primary Outcome Measures: Frequency, grade and relationship to STM-01 of unsolicited local and systemic AEs (any SAEs, MAAEs and AESIs ) during the 60-d follow-up period post IV infusion at D0 and D28 per the CTCAE v5.0 and clinical-safety laboratory parameters up to D 56., Dose 1 (Day 0) till end of study (Day 56)
Development of Novel Psychological Assessment Tools and Anxiety Intervention for Phenylketonuria
NCT Number: NCT06560736
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Phenylketonurias
Interventions: BEHAVIORAL: Show Me FIRST coping skills intervention
Sponsor: University of Missouri-Columbia
Collaborators: National PKU Alliance
Sex: ALL
Age: CHILD
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2026-08-31

Summary:
While previous PKU intervention research has largely focused on pharmacological treatment of elevated Phe levels, the adaptation of evidence-based psychosocial therapy holds promise for addressing cognitive and psychological symptoms and significantly improving quality of life. Study goals include: (1) to demonstrate the efficacy and feasibility of a short-term skills-based intervention (Show Me FIRST) for anxiety and depression in adolescents with PKU, and (2) to further establish the psychometric validity of novel assessment measures recently developed by the Investigators that utilize ecological momentary assessment (EMA) to capture "in the moment" neurocognitive and psychological function. The Investigators propose to conduct a randomized controlled trial wherein 30 adolescents with PKU will be randomized to either an immediate intervention group or wait-list/delayed intervention group.

Primary Outcome Measures: PROMIS Anxiety & Depression scales, Patient-reported outcome (PRO) measure of anxiety \& depression symptoms, Weeks 0, 11, & 22|Test My Brain phone-based EMA cognitive test, Performance-based measure of cognitive skill \& attention, Weeks 0, 11, & 22
Secondary Outcome Measures: Behavior Rating Inventory of Executive Function (BRIEF), Patient-reported outcome (PRO) measure of everyday symptoms of executive problems, Weeks 0, 11, & 22|Blood Phenylalanine Levels, Weeks 0, 5, 11, 16, & 22|ADHD Rating Scale - 4th version (ADHD-RS-IV), Patient-reported outcome (PRO) measure of ADHD symptoms, Weeks 0, 11, & 22|Executive Function, Attention, and Speed Symptom Inventory (EASSI) for PKU, Patient-reported outcome (PRO) measure of cognitive symptoms, Weeks 0, 11, & 22|Rey Auditory Verbal Learning Test (Rey AVLT), Performance-based measure of memory \& learning, Weeks 0, 11, & 22|Stop Signal Task (SST), Performance-based measure of inhibitory ability, Weeks 0, 11, & 22|Revised Children's Anxiety and Depression Scale (RCADS), Patient-reported outcome (PRO) measure of anxiety \& depression symptoms, Weeks 0, 11, & 22|Behavior & Feelings Survey (BFS), Patient-reported outcome (PRO) measure of internalizing \& externalizing problems, Weeks 0, 11, & 22|Adolescent Insomnia Questionnaire (AIQ), Patient-reported outcome (PRO) measure of sleep problems, Weeks 0, 11, & 22|Global Impression Scale, Patient-reported outcome (PRO) measure of overall symptom severity and improvement, Weeks 0, 11, & 22
Clinical Characteristics and Surgical Outcomes of Full-thickness Macular Hole Without Focal Vitreomacular Traction.
NCT Number: NCT06560710
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Macular Holes
Interventions: OTHER: vitrectimy
Sponsor: St. Marianna University School of Medicine
Collaborators: University of Toyama|Takaoka city Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2016-12-01
Completion Date: 2024-07-31

Summary:
This multicenter, retrospective, observational comparative study. We occasionally encounter FTMHs in which PVD has not been achieved and VMT is absent. These FTMHs cannot be defined by stage in the Gass1) or IVTS3) classification. It is not known whether traction is involved in the development of these atypical macular holes, but they are often classified as Gass stage 2 or 3 according to the size of the hole.

The aim of this study was to investigate the clinical features and surgical outcomes of FTMHs without focal VMT and to discuss possible underlying mechanisms.

Primary Outcome Measures: postoperative visual acuity, logMAR visual acuity, 1month, 3, 6 and 12 months
Secondary Outcome Measures: postoperative status of outer retinal layer in OCT B-scan images, External limiting mambrane, Elipsoid zone, Interdegitaion zone, 1month, 3, 6 and 12 months
CROSSOVER STUDY OF ON-DEMAND PREP FORMULATIONS COMPARING RECTAL AND ORAL TENOFOVIR
NCT Number: NCT06560684
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Tenofovir
Interventions: DRUG: Oral F/TDF Pills|DRUG: TFV rectal douche
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sex: MALE
Age: ADULT, OLDER_ADULT
Enrollment: 150
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2026-01
Locations: Alabama CRS (Site ID# 31788), Birmingham, Alabama, 35222, United States|UCLA CARE Center CRS, Los Angeles, California, 90035, United States|Hope Clinic CRS, Lawrenceville, Georgia, 30046, United States|Johns Hopkins University CRS, Baltimore, Maryland, 21205, United States|Fenway Health (FH) CRS, Boston, Massachusetts, 02215-4302, United States|Weill Cornell Chelsea CRS, New York, New York, 10011, United States|Chapel Hill CRS (3201), Chapel Hill, North Carolina, 27599-7215, United States|University of Pittsburgh CRS*, Pittsburgh, Pennsylvania, 15213, United States

Summary:
This is a Phase 2, multi-site, two-period, open label randomized crossover (Period 1 and 2) study. Participants are randomized 1:1 to one of two 8-week on-demand product sequences - TFV douche then oral F/TDF or oral F/TDF then TFV douche - with a 2 to 4-week washout period in between. Domains of safety, acceptability, adherence, and PK/PD (sub-study only) are assessed for each product.

Primary Outcome Measures: Grade 2 or higher adverse events during each study Period, For eGFR, participants may enroll in the study with an eGFR value consistent with a grade 2 adverse event; thus, an exception will be made for eGFR, which will be considered a safety outcome if it worsens to a grade 3 or higher., Week 1 through 19|Any adverse event leading to study product discontinuation during each study Period, Week 1 through 19|Self-report on ease of use, product liking, and likelihood of future use during each study Period, measured via computer-assisted self-interview (CASI), with the scales for the specific questions ranging from 1 (lowest ranking) to 4 (highest ranking)., Week 1 through 19
Secondary Outcome Measures: Proportion of participants who reported being most likely to use the TFV douche in the future (following Period 2), Week 1 through 19|Percent prescribed weekly doses taken in each Period using multiple subjective and objective measures, Week 1 through 19|TFV and FTC concentrations in blood plasma and rectal tissue biopsies, (Sub-study only), Week 1 through 19|TFV-DP and FTC-TP concentrations in PBMCs, rectal tissue biopsies, and mucosal mononuclear cells (MMC), (Sub-study only), Week 1 through 19
Compare the Patient Satisfaction and Effectiveness After Novel Application-based or Conventional Health Education of Bowel Preparation for Colonoscopy
NCT Number: NCT06560671
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Colo-rectal Cancer|Colon Lesion
Interventions: OTHER: novel type of health education
Sponsor: National Taiwan University Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 252
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2024-08-10
Completion Date: 2026-03-31
Locations: National Taiwan University Hsinchu Branch, Hsinchu, 300, Taiwan

Summary:
Colorectal cancer is the cancer with highest incidence in Taiwan. The disease itself and subsequent treatment cause huge impact on the physical, psychological, and spiritual parts and social role of a patient. Early diagnosis of colorectal cancer and precancerous lesions is possible. Early treatment can reduce the impact on quality of life and economics.

Colonoscopy is an important tool for diagnosis of colorectal proliferative lesions. Qualified bowel preparation can enhance sensitivity and reduce false negative of the colonoscopy. However, multiple factors influence the quality of bowel preparation. This study aims to investigate whether the animation video and game-based health education is more effective and satisfying than conventional health education, and to explore the difference of knowledge dissemination and quality of bowel preparation between novel and conventional methods.

This study is a randomized controlled trial and uses structural questionnaire for study participants. Before the main study, the investigators will consult professors' opinions to adjust and enhance validity of the questionnaire, and the investigators will perform pretest to calculate its reliability. The investigators will enroll participants at the out-patient-department and the health management center. Questionnaires may be completed by on-site paper or phone with internet resources. The main participants of this study are adults aged 18 and more, and planned to receive colonoscopy. The questionnaires investigate the spent time, patient satisfaction, knowledge of bowel preparation and results of colonoscopy of different approaches of health education. Multiple linear regression will be applied to calculate the possible significance difference between two kinds of health education.

The investigators expect this study (1) to explore whether novel health education enhances patient satisfaction (2) to investigate the efficiency of novel health education, and (3) to compare the effect of knowledge dissemination and quality of bowel preparation between experimental and control groups. This study will develop the model of health education to facilitate holistic health care.

Primary Outcome Measures: quality of bowel preparation, cleansing level of Aronchick scale 1-4, immediately after the procedure of colonoscopy
Secondary Outcome Measures: satisfaction, 5 points Likert scale, immediately after the intervention of health education
Phase 1 Trial of RP-3467 Alone and in Combination With Olaparib in Participants With Advanced Solid Tumors
NCT Number: NCT06560632
Acronym: POLAR
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Advanced Solid Tumor
Interventions: DRUG: RP-3467 at assigned dose and schedule|DRUG: Olaparib 200-300 mg BID, daily
Sponsor: Repare Therapeutics
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 52
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-10
Completion Date: 2028-12
Locations: Participating Site #1025, San Francisco, California, 94158, United States|Participating Site # 1008, New York, New York, 10032, United States|Participating Site # 1004, New York, New York, 10065, United States|Participating Site # 1001, Houston, Texas, 77030, United States

Summary:
This is a multicenter, open-label Phase 1 trial to investigate the safety, PK, and pharmacodynamics of the Polθ inhibitor RP-3467 alone or in combination with the poly-ADP ribose polymerase inhibitor (PARPi) olaparib in adults with molecularly selected advanced solid tumors.

Primary Outcome Measures: To assess the safety and tolerability of RP-3467 alone and in combination with olaparib, Incidence and severity of treatment-emergent adverse events (TEAEs) as assessed per NCI CTCAE v5.0 criteria, 20 months|To define a preliminary recommended Phase 2 dose (RP2D) of RP-3467 in combination with olaparib, 24 months
Secondary Outcome Measures: To assess PK parameters of RP-3467 alone or in combination with olaparib with calculation of maximum observed plasma concentration (Cmax), 19 months
A Phase 1 Clinical Trial of NTQ5082 in Healthy Volunteers
NCT Number: NCT06560593
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Complement-mediated Hemolytic Diseases
Interventions: DRUG: NTQ5082|DRUG: Placebo
Sponsor: Nanjing Chia-tai Tianqing Pharmaceutical
Sex: ALL
Age: ADULT
Enrollment: 82
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2025-02
Locations: The Third hospital of Changsha, Changsha, Hunan, 410035, China

Summary:
NTQ5082 capsule is a small molecule CFB factor inhibitor. The study is a randomized, double-blind, placebo-controlled, dose escalation phase 1 clinical trial to evaluate the safety, tolerability and PK/PD characteristics of NTQ5082 capsules orally administered in healthy subjects in single and multiple doses.

Primary Outcome Measures: the safety and tolerability, Safety and tolerability as assessed through collection of Adverse Event, Serious Adverse Event, Clinical Chemistry/Haematology/Coagulation/Vital Signs and ECG, up to 21 days
Secondary Outcome Measures: AUC0-last in plasma of part 1, up to 11 days|AUC0-∞ in plasma of part 1, up to 11 days|Cmax in plasma of part 1, up to 11 days|Tmax in plasma of part 1, up to 11 days|t1/2 in plasma of part 1, up to 11 days|Aet1-t2 in urine of part 1, up to 11 days|Ae0-t in urine of part 1, up to 11 days|Fe0-t in urine of part 1, up to 11 days|CLr in urine of part 1, up to 11 days|AUC0-τ in plasma after the first dosing of part 2, up to 21 days|AUC0-∞ in plasma after the first dosing of part 2, up to 21 days|Tmax in plasma after the first dosing of part 2, up to 21 days|Cmax in plasma after the first dosing of part 2, up to 21 days|AUC0-τ,ss in plasma under steady-state conditions (ss) of part 2, up to 21 days|AUC0-t,ss in plasma under steady-state conditions (ss) of part 2, up to 21 days|AUC0-∞,ss in plasma under steady-state conditions (ss) of part 2, up to 21 days|Tmax,ss in plasma under steady-state conditions (ss) of part 2, up to 21 days|Cmax,ss in plasma under steady-state conditions (ss) of part 2, up to 21 days|Ctrough,ss in plasma under steady-state conditions (ss) of part 2, up to 21 days|Cavg,ss in plasma under steady-state conditions (ss) of part 2, up to 21 days|t1/2,ss in plasma under steady-state conditions (ss) of part 2, up to 21 days
Attitudes and Barriers of Prosthetics and Orthotics Professionals in Turkey Towards 3D Printers and Technology
NCT Number: NCT06560567
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Technology
Sponsor: Medipol University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 131
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-01-10
Completion Date: 2023-06-10
Locations: Ayşe Yazgan, Bakırköy, İstanbul, 34158, Turkey

Summary:
This study aim is the attitudes and barriers of prosthetics and orthotics professionals towards 3D printers and technology will be determined.

Primary Outcome Measures: Technology Acceptance Model (TAM), While creating the TAM survey, a total of 23 questions were asked to measure the perceived of usefulness, perceived ease of use, attitude variable, intention variable and the behavior variable towards 3D Printing and Technology.

Questions were also asked to determine demographic characteristics. Demographic information questions are; participant's age, gender, education level, job, work experience (years), job geographic region, number of in-service trainings in orthotics and prosthetics, weekly working hours and number of patients contacted daily. At the end of the demographic information, participants were asked to clearly state their concerns about technology that they could not define.

While the questions regarding demographic targets in the survey were categorical, the questions measuring perceptions regarding the use of 3D printing and technology included 5-point Likert type answers. (1: Strongly disagree, 2: Disagree, 3: Neutral, 4: Agree, 5: Strongly agree), immediately after screening|Affinity for Technology Interaction (ATI), ATI evaluates the affinity to technology by focusing on user-system interaction. The scale takes into account cognitive needs to base affinity to technology on basic psychological structures and the questions are formulated accordingly. The title of the scale includes the statement that questions will be asked about interaction with technical systems. In our study, 3D Printer technology was stated to the participants as a technical system. The scale consists of 9 questions and the answers are in the form of a 6-point Likert scale: '1=Totally disagree, 2=Mostly disagree, 3=Partially disagree, 4=Partially agree, 5=Mostly agree, 6=Totally agree'. Finally, an average score was calculated over the 9 questions., immediately after screening
Evaluating the Effects of a Fermented Diet on Microbiome Diversity in Individuals With Long COVID
NCT Number: NCT06560554
Status: ENROLLING_BY_INVITATION
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Long COVID
Interventions: OTHER: Fermented foods|OTHER: Control
Sponsor: Mayo Clinic
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-08-29
Completion Date: 2025-02-28
Locations: Mayo Clinic, Rochester, Minnesota, 55904, United States

Summary:
The purpose of this study is to evaluate the effects of fermented foods on bacterial gut microbiome diversity of long-COVID subjects.

Primary Outcome Measures: Gut Microbiome diversity, High-dimensional microbiome data representing taxonomic features of the microbiomes will be analyzed to decode the community structure and key components that are associated with the condition of interest, At enrollment and completion of study (12 weeks)
Secondary Outcome Measures: Symptoms of depression and anxiety, Measured using the self-reported Hospital Anxiety and Depression Scale (HADS). Total questions: 14. Anxiety 7, Depression 7. Each item is rated on a 4-point scale from 0 "absence" to 3 "extreme presence". Total score is 21 per subscale: 0 - 7: Normal levels of anxiety/depression; 8-10: Borderline abnormal; \> 11: Abnormal, At enrollment and completion of study (12 weeks)|Assessment of cognition, Measured using the Montreal Cognitive Assessment (MoCA-BLIND). Total questions:13. Memory 3 Attention 4 Language 3 Abstraction 2 Orientation 1. Subscores for each of the 5 sections are calculated. The total score is summed from the subscores, with a maximum score of 22. A score equal \> 18 is considered normal cognition, At enrollment and completion of study (12 weeks)|Assessment of quality of life, Measured using the self-reported EuroQol-5D-3L questionnaire. Total questions: 6. Mobility: 1, Self-Care: 1, Usual Activities: 1, Pain/discomfort: 1, Anxiety/depression: 1, Health State - Visual Analog Scale: 1. 3L - 3 levels of severity: no problems, some problems, extreme problems. The visual analog scale ranges from 0 to 100 with higher scores reflecting better perceived current health-related quality of life state., At enrollment and completion of study (12 weeks)|Assessment of post-traumatic stress (PTSD) symptoms, Measured using Impact of Events-revised (IES-r). Total questions: 22. Intrusion 7, Avoidance 8, Hyperarousal 7. Items are rated on a 5-point scale ranging from 0 ("not at all") to 4 ("extremely"). Total scores are summed with higher scores indicating greater distress with regards to a specific event., At enrollment and completion of the study (12 weeks)
Other Outcome Measures: Research participant's subjective assessment of study adherence, During weekly phone calls, research participants will be asked to rate their adherence to the study protocol on a scale of 0 to 10, with zero being "not at all" and 10 being "exactly as recommended \[during the specific phase of the study\]"., At enrollment and weekly, through completion of the study (12 weeks)
Disitamab Vedotin Combined With Tislelizumab and Capecitabine in the Perioperative Treatment of Locally Advanced Gastric Cancer With HER2 Overexpression
NCT Number: NCT06560528
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Gastric Cancer|Gastroesophageal Junction Adenocarcinoma
Interventions: DRUG: combination with Disitamab Vedotin and with Tislelizumab and Capecitabine
Sponsor: Tianjin Medical University Cancer Institute and Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2028-09-01
Locations: Tianjin Medical University Cancer Institute & Hospital, Tianjin, Tianjin, 300060, China|Xuewei Ding, Tianjin, Tianjin, 300308, China

Summary:
The efficacy and safety of combination with Disitamab Vedotin and with Tislelizumab and Capecitabine for perioperative treatment of locally advanced gastric cancer with HER2 overexpression.

Primary Outcome Measures: Pathologic complete remission rate (PCR), Pathological complete response (pCR) rate is defined as the proportion of participants whose tumor in the stomach and lymph node completely disappeared, as determined by a pathologist., up to 1 years
Secondary Outcome Measures: Objective response rate(ORR), Overall response rate ( ORR) is defined as proportion of participants who have a best response of CR or PR, up to 3 years|Major pathological response rate (MPR), Major pathological response (MPR) rate is defined as the proportion of participants whose percentage of residual tumor in the stomach and lymph node decreased to \< 10%, as determined by a pathologist, up to 1 year|1-3-years event-free survival rate of 3year (EFS), 1-3 years event-free survival (EFS) rate is defined as proportion of participants who have no event, including disease progression, cessation of treatment for any reason, or death after 1-3 years of radical treatment., up to 3 years|1-3 years overall survival (OS) rate, 1-3 years overall survival (OS) rate is defined as proportion of participants who survived 1-3 years after radical treatment, up to 3 years|Adverse Events（AEs）, Defined as the proportion of patients with AE, treatment-related AE (TRAE), immune-related AE (irAE), serious adverse event (SAE), assessed by NCI CTCAE v5.0, up to 3 years
Dinoprostone Versus Vaginal Misoprostol for Induction of Labour
NCT Number: NCT06560515
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Induced Vaginal Delivery
Interventions: DRUG: Vaginal Dinoprostone
Sponsor: University of Alexandria
Sex: FEMALE
Age: ADULT
Enrollment: 370
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2022-08-01
Completion Date: 2023-10-31
Locations: ElShatby University Maternal Hospital, Alexandria, Egypt

Summary:
This randomized controlled study was carried out on 370 pregnant women with gestational age ≥ 40 weeks of different ages and parities at El-Shatby Maternity University Hospital after approval of ethical committee of Alexandria Faculty of Medicine. After assessment for eligibility \& enrollment in the study, women were randomly assigned into one of the two study groups, Group (I) received 3 mg vaginal Dinoprostone of maximum 2 doses 6 hours apart and Group (II) received 50 μg of vaginal misoprostol of maximum 2 doses 6 hours apart.

Primary Outcome Measures: Sucess of induction, percentage of women with a successful vaginal delivery, number of women who delivered vaginally after induction|Induction to delivery time, time lapse from receiving first dose of induction till delivery of the fetus, time from start of induction till delivery of the fetus
Secondary Outcome Measures: Postpartum hemorrhage, quantification of amount of postpartum bleeding, after delivery of the placenta|neonatal outcomes, Apgar Score at 1 and 5 minutes, at 1 and 5 minutes of delivery
Modified Multi-Platform Trial Assessing Multiple CAMPs and SOC vs SOC Alone in the Treatment of DFU and VLUs
NCT Number: NCT06560502
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Diabetic Foot Ulcer|Venous Leg Ulcer|Ulcer Foot|Leg Ulcer
Interventions: OTHER: Standard of Care-DFU|OTHER: AmnioCore - DFU|OTHER: Amnio Quad-Core - DFU|OTHER: Standard of Care-VLU|OTHER: Amnio Tri-Core - VLU|OTHER: AmnioCore Pro|OTHER: Amniocore Pro +
Sponsor: Stability Biologics
Collaborators: SerenaGroup, Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 324
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2026-08

Summary:
This is a multicenter, prospective, randomized controlled modified multi-platform (matriarch) trial evaluating several cellular, acellular, and matrix-like products (CAMPs) and standard of care versus standard of care alone in the management of nonhealing diabetic foot and venous leg ulcers.

Primary Outcome Measures: Determine the between-arm difference, To determine the between-arm difference in the proportion of subjects achieving complete closure of nonhealing diabetic foot ulcers and venous leg ulcers with multiple CAMPs plus SOC versus SOC alone over 12 weeks using a modified dual platform (Matriarch) trial design., 1-12 Weeks
Secondary Outcome Measures: Time to closure, To determine the between-arm difference in the time to closure over 12 weeks for CAMP plus SOC versus SOC alone., 1-12 Weeks|Percent Area Reduction, To determine the between-arm difference in the percent area reduction (PAR) at weekly intervals the CAMP plus SOC arms versus SOC alone., 1-12 weeks|Change in pain in target ulcer, To determine the between-arm difference in pain for patients that present with a VAS score of greater than 4., 1-12 Weeks|Adverse Events, To evaluate the between-arm difference in the frequency and nature of adverse events in subjects receiving CAMP plus SOC versus SOC alone., 1-14 weeks|Determine improvement in Quality of Life - FWS and determine improvement in Quality of Life - wQOL, To evaluate the between-arm difference in the quality of life for subjects receiving CAMP plus SOC compared to SOC alone using the Forgotten Wound Score (FWS) and standard Wound Quality of Life (wQOL) questionnaires at treatment visits 1, 4, 8, and 12., 1-12 weeks
Continuous Glucose Monitoring and OGTT Screen for Cystic Fibrosis Related Diabetes in Cystic Fibrosis
NCT Number: NCT06560463
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Cystic Fibrosis-related Diabetes|Cystic Fibrosis
Interventions: DEVICE: Access to Dexcom G7 CGM Data
Sponsor: Medical College of Wisconsin
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08
Completion Date: 2026-06

Summary:
Cystic Fibrosis (CF) related diabetes (CFRD) is a unique form of diabetes mellitus, different from type 1 diabetes and type 2 diabetes. The diagnosis of CFRD is associated with a decline in pulmonary function, decreased nutritional status, and increased mortality. CFRD is extremely common in people with CF, occurring in approximately 40-50% of adults with CF. Impaired glucose tolerance or dysglycemia is also very common in CF. It is standard of care to screen for CFRD annually from the age of 10 years with a two-hour Oral Glucose Tolerance Test (OGTT) with 75 g dextrose. The gold standard screening for CFRD is the OGTT which is problematic as it is time consuming for patient and staff and adherence to annual screening is low among CF centers.

Survival has improved dramatically with the advent of CFTR modulators and it is presumed that the incidence of CFRD will increase with increased life expectancy. The Cystic Fibrosis Foundation (CFF) has developed the oldest disease specific patient registry, consisting of approximately 35000 patients, so there is vast historical information available on individual patients and larger datasets on the CF community as a whole. Based on the 2021 CFF patient registry data, the current life expectancy for CF patients born between 2017 and 2021 is 53 years - a 15 year increase from a decade ago.

Primary Outcome Measures: Blood glucose measurement, Blood glucose levels will be continuously monitored over a ten-day period using a Dexcom G7 continuous glucose monitor (CGM), 10 days
Effects of the Manual Therapy on Brain Function in Young Chronic Neck Pain Patients
NCT Number: NCT06560437
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Neck Pain
Interventions: OTHER: Chinese Jingjin Manual Therapy
Sponsor: Wendi Zhang
Sex: ALL
Age: ADULT
Enrollment: 61
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: BASIC_SCIENCE
Start Date: 2023-04-01
Completion Date: 2024-08-14
Locations: Wendi Zhang, Hefei, Anhui, 230012, China

Summary:
The goal of this clinical trial is to study the central remodeling mechanism of young chronic neck pain patients based on resting-state functional magnetic resonance, and also to study the central analgesic mechanism of Chinese Jingjin Manual Therapy in treating young chronic neck pain patients. The main question it aims to answer are:

Are there specific differences in functional brain activities between young chronic neck pain patients and healthy volunteers? Are there specific changes in brain network function in young chronic neck pain patients before and after Chinese Jingjin Manual Therapy?

Participants will:

The patients in the neck pain group will receive Chinese Jingjin Manual Therapy three times a week for five consecutive weeks.

Before and after the Chinese Jingjin Manual Therapy, patients in the neck pain group were assessed by pressure pain threshold, Northwick Park Questionnaire, and Hospital Anxiety and Depression Scale.

In addition, resting-state functional magnetic resonance data will be collected from the neck pain group and the healthy control group.

Primary Outcome Measures: Amplitude of low-frequency fluctuation value, The amplitude of low-frequency fluctuation as a measure of the intensity of spontaneous activity in resting brain regions., 5 weeks|Tenderness threshold, The tenderness threshold a test of the maximum pain threshold that the patient can tolerate, 5 weeks|Northwick Park Questionnaire, The NPQ is a commonly used scale to assess functional impairment in patients with CNP. The lowest score is 0 and the highest score is 36. Higher scores indicate more severe neck dysfunction in the patient., 5 weeks|Hospital Anxiety and Depression Scale, The HADS scale can simultaneously assess the anxiety and depression status of CNP patients. The lowest score is 0 and the highest score is 52. The higher the score, the more severe the patient's emotional problems of anxiety and depression., 5 weeks
Cardiovascular and Metabolic Sciences Biorepository
NCT Number: NCT06560424
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Cardiovascular Diseases|Metabolic Disease
Sponsor: The Cleveland Clinic
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 10000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08
Completion Date: 2050-12-31
Locations: Cleveland Clinic Main Campus, Cleveland, Ohio, 44195, United States

Summary:
The purpose of the Cardiovascular and Metabolic Sciences Biorepository is to collect and store information and biospecimens (blood, urine, stool, and heart tissue) from patients with and without cardiovascular and metabolic diseases to create a readily available biorepository of samples and related medical health information to expedite future research into the causes and consequences of cardiovascular and metabolic diseases.

Primary Outcome Measures: Number of samples enrolled per year, Establish a biorepository of samples (blood, urine, stool, and heart tissue) and related medical health information to support future investigation into cardiovascular and metabolic diseases., Yearly through study completion (approximately 30 years)
Evaluation of Auto-EPAP for Management of Upper Airway Obstruction During Non-Invasive Ventilation
NCT Number: NCT06560411
Acronym: Vivo NOVA
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Obstructive Sleep Apnea|Obesity Hypoventilation Syndrome (OHS)|Chronic Obstructive Pulmonary Disease (COPD)|Neuromuscular Diseases (NMD)
Interventions: DEVICE: Non-Invasive Ventilation
Sponsor: Breas Medical, Inc.
Collaborators: Veranex
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-21
Completion Date: 2024-12
Locations: Insomnia and Sleep Institute of Arizona, LLC, Scottsdale, Arizona, 85255, United States|Delta Waves, Colorado Springs, Colorado, 80918, United States|Bogan Sleep Consultants, Columbia, South Carolina, 29201, United States

Summary:
To evaluate the safety and effectiveness of the Automatic Expiratory Positive Airway Pressure (Auto-EPAP) feature versus manual expiratory positive airway pressure (EPAP) in the Vivo 45 LS Ventilator.

Primary Outcome Measures: Exploratory effectiveness endpoint is to evaluate the subject's mean Oxygen Desaturation Index (ODI4%) during each overnight polysomnography assessment., The log of the subject's mean Oxygen Desaturation Index (ODI4%) measured during each overnight polysomnography assessment (i.e., log10 (mean+1))., Up to Five Weeks|Exploratory effectiveness endpoint is to evaluate the log of the subject's mean Apnea Hypopnea Index (AHI) during each overnight polysomnography assessment., The log of the subject's mean Apnea Hypopnea Index (AHI) measured during each overnight polysomnography assessment (i.e., log10 (mean+1))., Up to Five Weeks|The primary safety endpoint is the occurrence of device-related serious adverse events (SADEs)., Up to Five Weeks
Working Through Outreach, Navigation and Digital Enabled Referral and Recruitment Strategies (ACT WONDER²S)
NCT Number: NCT06560398
Acronym: ACT WONDER²S
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cancer
Interventions: BEHAVIORAL: Continuing Medical Education Events (CME)|BEHAVIORAL: Trial Connect Portal|BEHAVIORAL: Clinical Trial Newsletters|BEHAVIORAL: Implicit Bias Training|BEHAVIORAL: Recruitment Dashboard|BEHAVIORAL: Portfolio Profiler|BEHAVIORAL: Eligibility Calculator|BEHAVIORAL: Clinical Trial Education Sessions (Community Residents Only)|BEHAVIORAL: ACT WONDER²S Phone-line/Email (Community Residents and Moffitt Patients)|BEHAVIORAL: New Patient Information (Moffitt Patients Only)|OTHER: No Intervention
Sponsor: H. Lee Moffitt Cancer Center and Research Institute
Collaborators: National Cancer Institute (NCI)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 7649
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2024-09-01
Completion Date: 2026-09-01
Locations: Moffitt Cancer Center, Tampa, Florida, 33612, United States

Summary:
The purpose of the study is to refine, finalize, implement, and evaluate a multi-level intervention aimed at increasing enrollment of Black and Hispanic patients to National Cancer Institute (NCI)-sponsored therapeutic clinic trials at Moffitt Cancer Center.

Primary Outcome Measures: Enrollment of Black and Hispanic Patients to NCI-sponsored cancer treatment clinical trials, Intervention impact on enrollment rates will be measured by comparing the percentage of Moffitt patients enrolled on NCI-supported treatment trials who are Black or Hispanic between intervention priority zones and the control priority zones., 2 years
Secondary Outcome Measures: Referral of Black and Hispanic Patients to Moffitt Cancer Center, Intervention impact on referral rates will be measured by comparing the percentage of patients referred to Moffitt who are Black or Hispanic between the intervention priority zones and the control priority zones., 2 Years|Community residents in the intervention CAPZ, The number of community residents that attend a CT educational session., 2 years|Community physicians in the intervention CAPZ, The number of physicians that attend a CME event., 2 years|Cancer Center CRC, The number of CRCs that used at least one of the CT digital tools., 2 years|Cancer Center Physician, The number of MCC physicians that used at least one of the CT digital tools., 2 years
Alleviation of Alopecia in Breast Cancer Patient Using Synbiotics Formula
NCT Number: NCT06560385
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Breast Cancer|Hair Loss
Interventions: DIETARY_SUPPLEMENT: BLHK03|DIETARY_SUPPLEMENT: Active placebo
Sponsor: GenieBiome Limited
Sex: FEMALE
Age: ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: PREVENTION
Start Date: 2024-08-19
Completion Date: 2026-08-18
Locations: GenieBiome Limited, Hong Kong, Hong Kong

Summary:
This study aims to explore the efficacy and safety of a synbiotic formula (BLHK03) in alleviating chemotherapy-induced alopecia (CIA) in breast cancer patients and the compositional and functional changes in the gut microbiome of breast cancer patients undergoing chemotherapy and treatment with BLHK03.

Primary Outcome Measures: The proportion of subjects with a score of ≤ 2 on the Dean scale (corresponding to hair loss ≤ 50%) 2 months after the final dose of chemotherapy, The change of Dean scale (corresponding to hair loss) after chemotherapy compared to baseline. Score 0 means no hair loss and score 4 means all hair is fallen down., Baseline to 2 months after the final dose of chemotherapy
Secondary Outcome Measures: Gut microbial change at 2 months after the final dose of chemotherapy, The change of gut microbiota composition at 2 months after the final dose of chemotherapy compared to baseline, Baseline to 2 months after the final dose of chemotherapy|Adverse event rates related to the study during the study period, The adverse events reported throughout the study, Baseline to 2 months after the final dose of chemotherapy
Understanding the Natural History Early in the Course or Presentation of Friedreich Ataxia
NCT Number: NCT06560346
Acronym: EARLY-FA
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Friedreich Ataxia|Rare Diseases
Interventions: OTHER: Geneticlly confirmed disease causing FXN mutatuion
Sponsor: Friedreich's Ataxia Research Alliance
Sex: ALL
Age: CHILD, ADULT
Enrollment: 300
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-01
Completion Date: 2028-09-01
Locations: University of Iowa, Stead Family Children's Hospital, Iowa City, Iowa, 52242, United States|Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, 19104, United States|St. Jude Children's Research Hospital, Memphis, Tennessee, 38105, United States|Murdoch Childrens Research Institute, Parkville, Victoria, 3052, Australia|McGill University Health Centre - Montreal Neurological Institute, Montreal, Quebec, H9R 2Y2, Canada|University Hospital Aachen, Dept. of Neurology, Aachen, 52074, Germany|Bambino Gesù Children's Hospital, Department of Neurosciences, Roma, 00146, Italy

Summary:
Multicenter, prospective, observational natural history and outcome measure study of children and young adults with Friedreich ataxia.

Primary Outcome Measures: Association between growth (height) and disease severity in FRDA, Height will be measured using a wall-mounted stadiometer and univariate analyses will test for associations between the height Z-score (after accounting for genetic potential (mid-parental height)) and disease severity (using the standard ataxia scale modified Friedreichs ataxia rating scale (mFARS))., Baseline, 12 months, and 24 months
iSGLT2 Inhibitor and a iDPP -4 Inhibitor in Treatment of Type 2 Diabetes Mellitus in Patients Treated With Metformin (TRIAD)
NCT Number: NCT06560333
Acronym: TRIAD
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: N0892|DRUG: Januvia® + Glifage XR® + Placebo|DRUG: Forxiga® + Glifage XR® + Placebo
Sponsor: Eurofarma Laboratorios S.A.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 612
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2026-11-30
Completion Date: 2029-02-28
Locations: Eurofarma Laboratorios S.A, São Paulo, SP, 06696-00, Brazil

Summary:
The present study aims to evaluate the efficacy and safety of different combinations of oral antidiabetics in patients with inadequate glycemic control on metformin monotherapy.

Primary Outcome Measures: Evaluate the glycemic control at week 16, Evaluate the superiority of the combined use of N0892 in glycemic control (reduction in HbA1c: Glycated haemoglobin) at week 16 in subjects receiving metformin, compared to Forxiga® and Januvia® alone, 16 weeks