pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
My Best Alaskan Life: A Community-Designed Intervention to Improve Youth/Young Adults' Sexual and Mental Health
NCT Number: NCT06482242
Acronym: MBAL
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Community-Based Participatory Research|Adolescent Behavior|Mental Depression|Sexual Health
Interventions: BEHAVIORAL: My Best Alaska Life
Sponsor: University of Alaska Anchorage
Sex: ALL
Age: CHILD, ADULT
Enrollment: 320
Study Design: Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2025-05-01
Completion Date: 2027-10-01

Summary:
This project addresses critical public health disparities among Alaskan youth and young adults by developing and evaluating "My Best Alaskan Life" (MBAL), an innovative online tool aimed at improving sexual and mental health literacy and behaviors. By integrating motivational interviewing and the Health Belief Model, MBAL empowers individuals to make informed health decisions, thereby potentially reducing rates of sexually transmitted infections, HIV, and associated mental health issues. Long-term, this project aims to enhance overall health outcomes, particularly in underserved multicultural and Indigenous communities, while building local research capacity through undergraduate and graduate student engagement and mentorship.

Primary Outcome Measures: Motivation for Change, This validated shortened tool includes 3 questions per topic area, with four topics areas: sexual and reproductive health, emotional and behavioral health, life planning, \& sub-stance use., Baseline, immediate post, and 6 months post|Sexual Health, Condom/contraception use; HIV/STI testing; \& intention to delay sexual initiation (if not sexually active)., Baseline, immediate post, and 6 months post|Mental Health & Well-being, The Ryff Psychological Wellbeing Scale is an 18-item scale measuring six aspects of wellbeing and happiness: autonomy, environmental mastery, personal growth, positive relations with others, purpose in life, and self-acceptance., Baseline, immediate post, and 6 months post
M-TAPA vs Intraperitoneal Bupivacain vs Intraperitoneal Bupivacain +Dexmedetomidin
NCT Number: NCT06482229
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Regional Anesthesia Morbidity
Interventions: PROCEDURE: application for postoperative analgesia
Sponsor: Sivas State Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 45
Study Design: Allocation: RANDOMIZED|Intervention Model: FACTORIAL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: PREVENTION
Start Date: 2024-07-01
Completion Date: 2024-09-01

Summary:
Laparoscopic cholecystectomy is a common abdominal surgery in Western countries, favored for its minimal invasiveness, leading to less pain, smaller scars, and quicker recovery. Despite its benefits, it is contraindicated in cases of bleeding disorders, peritonitis, hemodynamic instability, severe heart failure, and advanced COPD. Effective postoperative pain management is crucial for faster recovery, shorter hospital stays, and lower costs, using techniques such as intravenous or intramuscular analgesics, epidural analgesia, and local anesthetic injections like TAP block or M-TAPA block. The TAPA block, introduced in 2019, involves applying local anesthetic to the costochondral junction, affecting thoracoabdominal nerves, with a modified version (M- TAPA) applying anesthetic to the lower surface only. Studies have shown M-TAPA's efficacy in reducing pain and analgesic use postoperatively. Postoperative pain from laparoscopic cholecystectomy mainly arises from inflammation in the gallbladder bed and pneumoperitoneum. This study aims to evaluate the postoperative analgesic efficacy of intraperitoneal bupivacaine, bupivacaine with dexmedetomidine, and M-TAPA block by assessing pain scores and analgesic consumption in a prospective, randomized, double- blind trial with 45 patients. Patients will be assigned to three groups: M- TAPA block, intraperitoneal bupivacaine, and intraperitoneal bupivacaine with dexmedetomidine, with an experienced anesthetist administering the blocks and evaluating outcomes to compare these pain management techniques.

Primary Outcome Measures: pain scores, zero meaning "no pain" and 10 meaning "the worst pain imaginable, Time Frame: 24 hours after the procedure
Secondary Outcome Measures: total analgesic consumption, total rescue analgesic consumption of patients will be evaluated, 24 hours after the procedure
Correlation of Protection Against Varicella in an Exploratory Study
NCT Number: NCT06482216
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Varicella
Interventions: BIOLOGICAL: Varicella vaccine
Sponsor: Sinovac (Dalian) Vaccine Technology Co., Ltd.
Sex: ALL
Age: CHILD
Enrollment: 400
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-10-10
Completion Date: 2027-10-10

Summary:
This study consists of two parts. Part 1 is a retrospective cohort study and part 2 is a prospective cohort study. In Part 1 ,the scaled logit model was used to assess the correlation between varicella-zoster virus (VZV) antibody titers using fluorescent-antibody-to-membrane-antigen assay (FAMA) 30 days after varicella vaccine immunization and the risk of subsequent varicella breakout/disease , to determine the protective threshold for achieving FAMA antibodies. Part 2 was to validate the model in part 1.

Primary Outcome Measures: Retrospective cohort: Varicella confirmed case, Varicella confirmed case during an additional year follow-up period (pooled with varicella confirmed case from previous phase Ⅲ study), one year after enrollment|Retrospective cohort: Varicella antibody titer, Varicella antibody titer on Day 30 after vaccination (historical serum), on Day 30 after vaccination|Prospective cohort: Varicella confirmed case, Varicella confirmed case during the 14-day follow-up period, Within 14 days after enrollment|Prospective cohort: Varicella antibody titer, Varicella antibody titer on exposure, Enrollment
Secondary Outcome Measures: Prospective cohort: Varicella antibody titer, Varicella antibody titer in the acute period of varicella confirmed case, Within 3 days after eruption|Prospective cohort: Varicella antibody titer, Varicella antibody titer in the convalescent period of varicella confirmed case, Within 14-21 days after eruption
Trunk Extensor Endurance Training Versus Scapular Mobilization in Patient With Thoracic Kyphosis
NCT Number: NCT06482203
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Thoracic Kyphosis
Interventions: OTHER: Trunk Extensor Endurance training & Scapular mobilization
Sponsor: Riphah International University
Sex: ALL
Age: ADULT
Enrollment: 28
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06
Completion Date: 2024-07-07
Locations: Lady Reading Hospital(LRH), Peshawar, Khyber Pakhutunkhuwa, 25000, Pakistan

Summary:
To compare the effect of Trunk extensor endurance training and scapular mobilization on thoracic pain in patient with thoracic kyphosis.

To compare the effect of Trunk extensor endurance training and scapular mobilization on kyphotic angle in patient with thoracic kyphosis To compare the effect of Trunk extensor endurance training and scapular mobilization on shoulder ROM in patient with thoracic kyphosis

Primary Outcome Measures: Thoracic pain, NPRS(Numeric pain rating scale), 4 weeks|kyphotic angle, Inclinometer, 4 weeks|Shoulder ROM, Goniometer, 4 weeks
The COAT Trial: Cequa's Onset of Action Trial
NCT Number: NCT06482177
Acronym: COAT
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Dry Eye
Interventions: DRUG: Cyclosporine ophthalmic solution
Sponsor: Research Insight LLC
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 52
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-10-12
Completion Date: 2024-06-05
Locations: Harvard Eye Associates, Laguna Hills, California, 92653, United States

Summary:
Cequa's Onset of Action Trial: an Investigation of CEQUA's Speed of Onset in Improving Ocular Surface Health in Dry Eye Patients

Primary Outcome Measures: Change in corneal high order aberrations (HOA), Change in corneal HOA, After 7, 14, and 28 days of treatment
Secondary Outcome Measures: Change in corneal staining, Corneal staining, After 7, 14, 28 days of treatment
Other Outcome Measures: Change in best corrected visual acuity, Best corrected visual acuity, After 7, 14, and 28 days of treatment
The THINK Study Incidence of Neurotrophic Keratopathy)
NCT Number: NCT06482164
Acronym: THINK
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Dry Eye
Interventions: DIAGNOSTIC_TEST: Dry Eye Disease
Sponsor: Research Insight LLC
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SCREENING
Start Date: 2024-04-05
Completion Date: 2025-04-01
Locations: Harvard Eye Associates, Laguna Beach, California, 92653, United States

Summary:
The study purpose is to evaluate corneal sensitivity in patients that have Stage 1 Neurotrphic Keratopathy (NK). Identifying patients with Stage 1 NK, may predict those who will in the future require rhNGF for optimal visual performance.

Primary Outcome Measures: Patients with stage 1 neurotrophic keratopathy (NK), Patients with stage 1 neurotrophic keratopathy NK among dry eye patients, Baseline Visit 0
Dysfunction of Olfaction After COVID-19 Infection: Morphological and Histomolecular Investigation
NCT Number: NCT06482138
Acronym: DysOSMIC
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Covid19|Olfactory Dysfunction
Interventions: PROCEDURE: Biopsy and Cytobrush
Sponsor: Universitaire Ziekenhuizen KU Leuven
Collaborators: University Hospital, Geneva|Max Planck Research Unit for Neurogenetics|University Hospital Carl Gustav Carus|University of Zurich
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 160
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-01-24
Completion Date: 2025-03-31
Locations: UZ/KU Leuven, Leuven, Vlaams-Brabant, 3000, Belgium|Max Planck Research Unit for Neurogenetics, Frankfurt am Main, Frankfurt, 60438, Germany|University Hospital Carl Gustav Carus, Dresden, 01307, Germany|Hôpitaux Universitaires de Genève, Genève, 1211, Switzerland|University of Zurich and University Hospital Zurich, Zürich, 8091, Switzerland

Summary:
Investigation of the mechanisms of persistent SARS-CoV-2 associated olfactory dysfunction (OD) in patients with well-documented olfactory function. The investigators plan to collect olfactory cleft biopsies and cytobrushes in COVID-19 patients and controls.

Primary Outcome Measures: Analysis of olfactory cleft biopsies, Morphological and histomolecular differences between OD and control patients

* Evaluating tissue pathology:

  * Metaplasia
  * hypertrophy
  * aberrant scar formation
  * apoptosis
  * presence of inflammatory cells \[H\&E, CD68 and CD3 stainings, RNAscope\]
* Presence of SARS-CoV-2 RNA
* Percentage of OSNs versus sustentacular cells; maturation of OSNs, From enrollment of 1 patient until analyzed, 1 month|Analysis of olfactory cytobrushes, Morphological and histomolecular differences between OD and control patients

* Evaluating tissue pathology:

  * Metaplasia
  * hypertrophy
  * aberrant scar formation
  * apoptosis
  * presence of inflammatory cells \[H\&E, CD68 and CD3 stainings, RNAscope\]
* Presence of SARS-CoV-2 RNA
* In the olfactory epithelium: percentage of OSNs versus sustentacular cells; maturation of OSNs, From enrollment of 1 patient until analyzed, 1 month
Emergence Agitation is a Problem in Pediatric Anesthesia. We Aim to Lower Its Incidence by Using Dexmedetomidine
NCT Number: NCT06482125
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Emergence Delirium
Interventions: DRUG: Total Intravenous Dexmedetomidine|DRUG: Inhalation Sevoflurane
Sponsor: Pelita Harapan University
Sex: ALL
Age: CHILD
Enrollment: 84
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: PREVENTION
Start Date: 2024-07-01
Completion Date: 2024-12-31
Locations: Pelita Harapan University, Tangerang, Banten, 15811, Indonesia

Summary:
Emergence agitation is commonly encountered after receiving inhalation anesthesia. This distressing phenomenon carries risks that are harmful to patients, caregivers and medical personnel. Using total intravenous Dexmedetomidine, the investigators seek to reduce agitation and provide gentle emergence from anesthesia.

Primary Outcome Measures: Emergence Agitation, Incidence of emergence agitation upon receiving inhalation Sevoflurane or intravenous Dexmedetomidine as their sole anesthetic maintenance agent, Assessed starting the time of extubation and every 15 minutes interval until the patient is completely awake in the recovery room
SPECIAL INVESTIGATION FOR ABRYSVO IN PREGNANT WOMEN AND INFANTS
NCT Number: NCT06482099
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Respiratory Tract Infection
Interventions: BIOLOGICAL: RSVpreF vaccine
Sponsor: Pfizer
Sex: FEMALE
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 490
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-30
Completion Date: 2026-04-24
Locations: Pfizer, Tokyo, 151-8589, Japan

Summary:
This post-marketing study is a multicenter cohort study in pregnant women vaccinated with Abrysvo (RSV vaccine）designed to confirm the safety in pregnant women and their infants under actual clinical practice in Japan.

Primary Outcome Measures: Percentage of pregnant women reporting Adverse Reactions for 28 days after vaccination, up to 28 days after vaccination|Percentage of pregnant women reporting Serious Adverse Reactions from the day of vaccination up to 28 days after delivery, up to 28 days after delivery|Percentage of pregnant women reporting reactogenicity events (local reactions and systemic events) from day of vaccination up to 7 days after vaccination, up to 7 days after vaccination|Percentage of infants reporting Adverse Reactions from the birthday up to 28 days after birth, up to 28 days after birth|Percentage of infants reporting Serious Adverse Reactions from the birthday up to 28 days after birth, up to 28 days after birth
Efficacy of Organoid-Based Drug Screening to Guide Treatment for Locally Advanced Thyroid Cancer
NCT Number: NCT06482086
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Locally Advanced Thyroid Gland Carcinoma
Interventions: DRUG: Anlotinib|DRUG: Lenvatinib|DRUG: Sorafenib|DRUG: Donafenib|DRUG: Everolimus|DRUG: Apatinib|DRUG: Dabrafenib + Trametinib|DRUG: Cabozantinib|DRUG: Vandetanib|DRUG: Entrectinib|DRUG: Pralsetinib|DRUG: Larotrectinib
Sponsor: West China Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 75
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2021-06-01
Completion Date: 2025-12-01
Locations: West China hospital, Chengdu, Sichuan, 610041, China

Summary:
The current study aims to explore the potential advantages of anti-cancer therapy that is implemented based on drug sensitivity testing. This pertains to individuals with locally advanced thyroid cancer who have undergone conventional therapy in the past or unresectable patients .

Primary Outcome Measures: Objective response rate, ORR is defined as the percentage of patients who achieve a response, which can either be complete response (complete disappearance of lesions) or partial response (reduction in the sum of maximal tumor diameters by at least 30% or more), Every 8 weeks until progression up to 3 years|Progress-free survival, PFS is defined as the time from the administration of the first dose to first disease progression or death., Every 8 weeks until progression or death up to 3 years|Overall R0/R1 resection rate, Defined as the proportion of patients who undergo R0/R1 resection among all patients., Up to 36 months.
Secondary Outcome Measures: Overall Survival, OS is defined as the time from the administration of the first dose to death., Up to 36 months.|Change in Surgical complexity and morbidity score (SCMS), The Thyroid Neck Group Morbidity Complexity Scoring and MGH/MEE-MSK-MD Anderson (MMM) Surgical Morbidity Complexity Score (SMCS) are incorporated, specifying on scale with 5 levels of complexity and morbidity of the surgery \[mild (level 0), moderate (level 1), severe (level 2), very severe (level 3), and unresectable (level 4)\]. The surgical morbidity/complexity scores will be collected at enrollment, prior to surgery, and based on intraoperative findings.

The change in SCMS will be reported as the median SCMS value. Determined by structures requiring resection, the score takes into account preoperatively radiographically defined structures judged to be requiring resection with surgical complexity of the given resection/potential for complications, and expected patient morbidity/change of function from the resection., Up to 36 months|Number of Participants with Treatment Related Adverse Events as Assessed by CTCAE v 5.0, Up to 36 months
Molecular Analysis of Suspected or High-Risk Lung Cancer to Drive Individualized Care (Interception for Suspected Lung Cancer)
NCT Number: NCT06482073
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Lung Carcinoma|Metastatic Malignant Neoplasm in the Lung
Interventions: OTHER: Non-Interventional Study
Sponsor: Mayo Clinic
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-24
Completion Date: 2027-07-01
Locations: Mayo Clinic in Rochester, Rochester, Minnesota, 55905, United States

Summary:
This study evaluates the effectiveness of robotic biopsies in providing information about hereditary or cancer specific genetic variants that may have a role in diagnosis of cancer and to develop genetic results and medical record databank for future studies.

Primary Outcome Measures: Percent of samples adequate for sequencing, Assessed based on the number of tissue samples determined to be adequate for WES (Whole Exome Sequencing)/WT (wild-type) sequencing., Up to 2 years
Secondary Outcome Measures: Data bank of genomic data, A data bank of genomic data will be developed for future analyses., Up to 2 years
Boosting Executive Function With Brain Exercise
NCT Number: NCT06482047
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Sedentary Behavior
Interventions: BEHAVIORAL: Moderate-intensity cycling|BEHAVIORAL: Vigorous-intensity cycling|BEHAVIORAL: Uninterrupted sitting
Sponsor: Liye Zou
Sex: ALL
Age: ADULT
Enrollment: 80
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-07-02
Completion Date: 2025-04-15
Locations: Body-Brain-Mind Laboratory, School of Psychology, Shenzhen University, Shenzhen, China

Summary:
The goal of this study is to explore the impact of a 15-minute exercise break on brain function and cognitive performance in a simulated classroom setting. The main questions it aims to answer are:

1. How do short exercise breaks affect executive function in college students?
2. What changes occur in brain connectivity and microcirculation after these exercise breaks? Participants were college students who engaged in sessions of continuous sitting or sitting interspersed with exercise. The study used cognitive tasks and brain imaging techniques to measure the effects. The findings reveal improvements in cognitive performance and brain function, suggesting that short exercise breaks are beneficial in educational contexts.

Primary Outcome Measures: Cognitive function, This primary outcome measure is assessed by the modified dual-task Stroop paradigm., 3 weeks|Retinal Vessel Diameter, Retinal Vessel Diameter is assessed by the fully automated fundus camera., 3 weeks|Brain Connectivity, Brain connectivity is assessed by the NIRSport2 device, 3 weeks
Effect of N-acetyl Cysteine and Zinc in Management of Head and Neck Cancer Radiotherapy Induced Oral Mucositis
NCT Number: NCT06482034
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Radiation-Induced Mucositis
Interventions: DRUG: N-acetyl cysteine|DRUG: Zinc sulfate|DRUG: saline mouth wash
Sponsor: Mansoura University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2023-06-28
Completion Date: 2024-11
Locations: Mansoura university, Mansoura, Egypt

Summary:
The majority of individuals diagnosed with head and neck cancer, who undergo radiotherapy or concurrent Chemoradiotherapy, experience oral mucositis. Our research focuses on investigating the preventive and therapeutic impact of N-acetylcysteine and zinc in managing radiotherapy-induced oral mucositis.

Primary Outcome Measures: Incidence of Radiotherapy-Induced Oral Mucositis, The incidence of any grade of oral mucositis will be measured in each group. This will be evaluated by recording the number of patients who develop oral mucositis during and after radiotherapy treatment., From the start of radiotherapy to 2 weeks after the completion of radiotherapy.|Time to Onset of Oral Mucositis, The time from the start of radiotherapy to the onset of any grade of oral mucositis in groups I, II, III, and V (control group). This will be measured by tracking the number of days until the first appearance of mucositis symptoms., From the start of radiotherapy to the onset of oral mucositis, monitored daily during radiotherapy and up to 2 weeks after completion of radiotherapy.|Severity of Oral Mucositis, The severity of oral mucositis will be measured using the World Health Organization (WHO) criteria for grading oral mucositis, which includes objective symptoms (redness, edema, wound development) and subjective symptoms (dysphagia, mucosal severity). Mucositis will be classified into grades:

Grade 0: No change or erythema without pain. Grade 1: Pain with or without erythema, no ulcers. Grade 2: Oral erythema and ulcers, but the patient can eat solid and liquid food.

Grade 3: Oral erythema and ulcers, the patient can eat only liquid/puree food. Grade 4: Severe oral ulcers; patient cannot eat solid or liquid food., Assessed weekly during radiotherapy and up to 2 weeks after the completion of radiotherapy.
Comparative Effectiveness Of Low Extra-Corporeal Shock Wave Versus Acetylcholine Iontophoresis On Type2 Diabetic Neuropathy
NCT Number: NCT06482021
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Diabetic Nephropathy
Interventions: DEVICE: Low-intensity extracorporeal shock wave
Sponsor: South Valley University
Sex: ALL
Age: ADULT
Enrollment: 80
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-07-10
Completion Date: 2024-10-01

Summary:
In our thesis, we will compare the effectiveness of low-intensity shock wave versus acetylcholine iontophoresis as a possible new therapy for microcirculation changes in type 2 diabetic neuropathy

Primary Outcome Measures: Electrophysiological investigations of peripheral nerves (latency, amplitude and velocity of peripheral nerves), Electrophysiological investigations of peripheral nerves were measured pre and post treatment for both groups (latency, amplitude and velocity of peripheral nerves), Six weeks
Secondary Outcome Measures: Nitric oxide laboratories for measurement of nitric oxide level, Nitric oxide laboratories for measurement of nitric oxide level were measured pre and post treatment for both groups., Six weeks
Value of Advanced MRI Techniques in the Assessment of Endometriosis
NCT Number: NCT06481982
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Endometriosis
Interventions: DIAGNOSTIC_TEST: MRI
Sponsor: University of Zurich
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 300
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-01
Completion Date: 2029-08-01
Locations: University Hospital Zurich, Zurich, ZH, 8091, Switzerland

Summary:
Endometriosis is a common gynaecological disease, mostly in women of reproductive age, with a prevalence of about 10 %, which is defined by the presence of endometrial-type tissue outside the uterine cavity. Endometriosis is usually limited to the abdominal and especially the pelvic cavity, extra-abdominal lesions are rare. Within the pelvis it shows a wide variety of locations predominantly affecting the ovaries and the uterus or the peritoneum, uterine ligaments and other pelvic structures. Traditionally, there are three major phenotypes of endometriosis: Ovarian endometrioma (OMA), superficial peritoneal endometriosis (SPE), and deep infiltrating endometriosis (DIE). A lesion is considered a DIE, if it shows infiltration deeper than 5 mm into the peritoneum. The ectopic endometrial implants may induce inflammatory processes, causing scar tissue formation, adhesions, and consequently pelvic anatomy distortion.

The prospective study aims to investigate the value of advanced MRI techniques to improve the assessment of pelvic endometriosis.

Primary Outcome Measures: Diagnostic Accuracy, Diagnostic accuracy of different MRI sequences in comparison to ultrasound assessment and/or laparoscopy as standard of reference., 5 years
T-DM1 Combined With CDK4/6 Inhibitor Ribociclib
NCT Number: NCT06481956
Status: ENROLLING_BY_INVITATION
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: HER2-positive Advanced Breast Cancer
Interventions: DRUG: Ribociclib Oral Tablet
Sponsor: Zheng Yabing
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-10-25
Completion Date: 2027-10-10
Locations: Zhejiang Cancer Hospital, Hangzhou, Zhejiang, 310022, China

Summary:
To explore the efficacy and safety of T-DM1 combined with CDK4/6 inhibitor Ribociclib in the treatment of HER2-positive advanced breast cancer.

Primary Outcome Measures: Objective Response Rate (ORR), ORR is defined as the percentage of patients who achieved a best overall response of Complete Response (CR) or Partial Response (PR), per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1) for target lesions as assessed by the Investigator: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters., up to 54 months
Secondary Outcome Measures: Progression-Free Survival (PFS), From date of first dose until the date of first documented progression or date of death from any cause, whichever came first., up to 54 months|2-year Overall Survival (OS), the overall survival rate in all patients from the date of first dose to the end of follow-up at 2 years., up to 54 months|Objective Response Rate of Subgroup Population (ORR), Objective Response Rate of subgroup population (ER\>=10% vs ER\<10%), up to 54 months|Adverse Event (AE), Evaluation performed using the National Cancer Institute (NCI)- Standard for Common Terminology for Adverse Events (CTCAE)v.5.0., up to 54 months
A Prospective Research Investigation of Ischemia Using MCG
NCT Number: NCT06481943
Acronym: PRISM
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Acute Coronary Syndrome
Interventions: DEVICE: Sponsor MCG device (CardiAQ)
Sponsor: SB Technology, Inc.
Collaborators: Mayo Clinic
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 150
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07
Completion Date: 2025-06
Locations: Mayo Clinic, Rochester, Minnesota, 55905, United States

Summary:
PRISM is a prospective, pilot research study that aims to systematically characterize the usefulness of CardiAQ MCG, a bedside magnetocardiography device, in the evaluation of myocardial ischemia and infarction status.

Primary Outcome Measures: Relationship between pre-procedural MCG and the peri-procedural angiography-based measures, Utilize linear regression and logistic regression to determine whether a set of a priori MCG-based biomarkers can prospectively predict the objective clinical assessment of ACS, while statistically adjusting for covariates., Data taken within 24 hours of each other
Secondary Outcome Measures: Sponsor MCG device safety, Device-related adverse events, 30 days
A Multicenter Real-world Study of Screening of Cervical Cancer Based on Photoelectric Detection
NCT Number: NCT06481930
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Uterine Cervical Cancer|High Grade Squamous Intraepithelial Lesions|Low Grade Squamous Intraepithelial Lesions
Interventions: DIAGNOSTIC_TEST: Detection of Cervical Lesions by Fluorescence Photoelectric Image
Sponsor: Lei Li
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 20000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07
Completion Date: 2026-07
Locations: Lei Li, Beijing, Beijing, 100730, China

Summary:
The main purpose of this study is to explore the accuracy and clinical value of fluorescent photoelectric cervical lesion image detector as a screening and shunt tool for cervical lesions through a multi-center, large-sample real-world study with histopathology as the gold standard. The secondary purpose of the study was to verify the coincidence of the fluorescent photoelectric cervical lesion image detector with traditional colposcopic chemical staining.

This study is expected to include 20,000 participants with definite histological results, and compare the specificity and sensitivity, negative predictive value and positive predictive value of three cervical lesion screening methods, such as fluorescent photoelectric cervical lesion image detector, HPV nucleic acid detection and cytology detection. The advantages and disadvantages of fluorescent photoelectric cervical disease image detector, HPV nucleic acid detection and cytology examination were analyzed, and their application scenarios were provided to provide evidence-based medical support for the establishment of comprehensive prevention and treatment system of cervical cancer suitable for China's national conditions.

Primary Outcome Measures: Accuracy of tissue lesion screening based on photoelectric detection, The sensitivity, specificity, positive predictive value and negative predictive value of fluorescence photoelectric cervix lesion image detector were calculated by using CIN 2 + as the gold standard determined by histopathology, and compared with those of HPV and TCT., The data collection time for each subject is approximately 7 days, starting from the day of each subject's enrollment and ending when the pathology report of the cervical tissue biopsy under colposcopy is issued.
Registry for Stage 2 Type 1 Diabetes
NCT Number: NCT06481904
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Type 1 Diabetes
Interventions: DRUG: TZIELD (teplizumab-mzwv)
Sponsor: Sanofi
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-26
Completion Date: 2037-01-15
Locations: Ten's Medical PC Site Number : 8400027, Staten Island, New York, 10306, United States

Summary:
Stage 2 Type 1 Diabates (T1D) is an early stage of T1D characterized by dysglycemia but not yet leading to clinical symptoms. Progression of the disease to Stage 3 (clinical T1D), leads to overt hyperglycemia requiring eventually exogenous insulin.

TZIELD® (teplizumab-mzwv) has been approved to delay onset of stage 3 T1D, by the United States (US) Food and Drug Administration (FDA) for adults and children aged 8 years and older with Stage 2 T1D.

The purpose of this study is to collect general information on patients with stage 2 T1D and further information on the long-term effects of TZIELD® in patients with Stage 2 T1D, treated as per standard of care.

Primary Outcome Measures: Number of adverse events of special interests (AESI), Presence of AESIs including cytokine release syndrome (CRS), serious infections, hypersensitivity reactions, lymphoproliferative disorders, and malignancies, Throughout the study, approximately 10 years|Number of serious adverse events (SAE), Throughout the study, approximately 10 years|Number of adverse events (AE) in mothers, fetuses, and infants exposed to TZIELD during pregnancy, From start of pregnancy to 12 months post-partum|Number of maternal pregnancy-related events, From start of pregnancy to 12 months post-partum|Developmental outcomes of the infant, From birth of infant to 12 months
A Study to Evaluate the Efficacy and Safety of Sotagliflozin in Symptomatic Obstructive and Non-obstructive Hypertrophic Cardiomyopathy
NCT Number: NCT06481891
Acronym: SONATA-HCM
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Obstructive Cardiomyopathy, Hypertrophic|Non-obstructive Hypertrophic Cardiomyopathy
Interventions: DRUG: Sotagliflozin|DRUG: Placebo
Sponsor: Lexicon Pharmaceuticals
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 500
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-06-28
Completion Date: 2026-08
Locations: Lexicon Investigational Site (4036), Merrillville, Indiana, 46410, United States

Summary:
The main purpose of the study is to determine the changes in symptoms and functional limitations in participants with symptomatic hypertrophic cardiomyopathy (HCM) treated with sotagliflozin as compared to placebo.

Primary Outcome Measures: Change from Baseline to Week 26 in Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ CSS), KCCQ is a 23-item, self-administered questionnaire that measure the participant's perception of their health status, including their heart failure (HF) symptoms, impact on physical and social function and how their HF impacts the quality of life. KCCQ quantifies 7 domains: physical limitations (6 items), symptom stability (1 item), symptom frequency (4 items), symptom burden (3 items), self-efficacy (2 items), quality of life (3 items) and social limitations (4 items). Scores are generated for each domain and scaled from 0 to 100, with 0 denoting the worst and 100 the best possible status. Higher scores reflect better health status., Baseline to Week 26
Secondary Outcome Measures: Percentage of Participants at Week 26 with a New York Heart Association (NYHA) Functional Class Improvement ≥ 1 Category, NYHA functional class is a clinician-reported assessment of participants' health status on a 4-point scale, where Class I represents no limitations in normal activity; Class II indicates slight limitation of physical activity; Class III indicates marked limitation in physical activity; and Class IV indicates that participants have symptoms with any physical activity or at rest. Percentage of participants with NYHA functional class improvement ≥1 will be reported., Week 26|Change from Baseline to Week 26 in KCCQ Total Symptom Score (TSS)., KCCQ is a 23-item, self-administered questionnaire that measure the participant's perception of their health status, including their HF symptoms, impact on physical and social function and how their HF impacts the quality of life. KCCQ quantifies 7 domains: physical limitations (6 items), symptom stability (1 item), symptom frequency (4 items), symptom burden (3 items), self-efficacy (2 items), quality of life (3 items) and social limitations (4 items). Scores are generated for each domain and scaled from 0 to 100, with 0 denoting the worst and 100 the best possible status. Higher scores reflect better health status., Baseline to Week 26
Impact of Starting Dose of Vasopressor on Hemodynamic Response in Shock
NCT Number: NCT06481839
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Shock
Interventions: OTHER: Starting dose of NE
Sponsor: University of Illinois at Chicago
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 120
Study Design: Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-24
Completion Date: 2028-07-24

Summary:
This study is designed to assess the effect of initial vasopressor dose on clinical outcomes. To date, there are no clinical guidelines or recommendations regarding the dose of vasopressor medication that should be initiated before titrating to a mean arterial pressure (MAP) in patients with circulatory shock. High heterogeneity and clinical equipoise regarding this variable exist in routine clinical practice. However, there is strong evidence that delays in achieving MAP goals lead to worse clinical outcomes. The study will randomize patients with circulatory shock to a low (5mcg/min of norepinephrine) or high (15mcg/min of norepinephrine) initial starting dose followed by the usual protocolized titration to MAP goal. The time to reach the goal MAP, organ dysfunction, hospital length of stay, and mortality will be measured for each group.

Primary Outcome Measures: Mean arterial blood pressure, Time to achieve and sustain a mean arterial pressor greater than or equal to 65 mmHg, During first shock episode, up to 28 days of shock episode.
Glofitamab in Chinese Patients With R/R DLBCL
NCT Number: NCT06481826
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: DLBCL - Diffuse Large B Cell Lymphoma
Interventions: DRUG: Glofitamab
Sponsor: Peking Union Medical College Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-01-01
Completion Date: 2028-12-31
Locations: Peking Union Medical College Hospital, Beijing, Beijing, 100730, China

Summary:
This study will evaluate the safety and efficacy of glofitamab as a single agent in Chinese patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who have failed two or more lines of systemic therapy.

Primary Outcome Measures: PFS, Progression-free survival, 1 year
Secondary Outcome Measures: OS, overall survival, 2 year|CR rate, complete response, 6 weeks, 18 weeks, 36 weeks|ORR, overall response rate, 6 weeks, 18 weeks, 36 weeks|DOR, duration of response, 2 year|AE, Rate and type of adverse events (AEs) and serious adverse events (SAEs), 2 year
Prospective, Longitudinal Biocollection in Thoracic Oncology, Including Newly Diagnosed Lung Cancer Patients
NCT Number: NCT06481813
Acronym: BREATHE
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Lung Cancer|Carcinoma, Non-Small-Cell Lung|Small Cell Lung Carcinoma|Metastatic Lung Cancer
Interventions: OTHER: Blood Sampling (2*8mL Tubes)|OTHER: PBMC Sampling (1*8mL Tubes)|OTHER: Paxgene Sampling
Sponsor: Nantes University Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 700
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-09-01
Completion Date: 2034-09-01

Summary:
In clinical trials, patients are selected according to strict eligibility criteria (inclusion and exclusion criteria). These criteria aim to ensure homogeneity within the trial population, but may omit patients with specific characteristics, comorbidities or co-medications. Indeed, patients of advanced age, with comorbidities or brain metastases, who are frequently encountered in clinical practice, are often excluded from clinical trials. Real-life data in oncology play a vital role in assessing the efficacy of therapies and therapeutic strategies, complementing data from controlled clinical trials. They make it possible to analyze a larger population and take into account multiple variables such as patient history, co-medications and comorbidities, but also to analyze efficacy and toxicity data in populations not represented in clinical trials. The establishment of a prospective cohort including various stages and histologies will make it possible to set up a platform of available data, including a maximum of data linked to the patient, his tumor and his treatments, collected longitudinally until the patient's death (or the end of the study).

In parallel with this cohort, the project aims to set up a longitudinal plasmatheque (from diagnosis to death, or at the end of the study), as well as a tumorotheque (samples systematically stored as part of care by the CHU tumorotheque, and for which patient consent allows their use in research depending on the material available) for patients with available tumor samples. This will enable the construction of ancillary projects to validate research hypotheses, for example concerning the identification of mechanisms of resistance to therapies.

The main objective is to identify factors associated, including biomarkers, with response or resistance to anti-cancer therapies.

Primary Outcome Measures: Overall survival, Overall Survival is the delay between the date of inclusion and the date of death or last follow-up assessment if censored., 5 years
PMR Versus MLD on RLS and Sleep Quality in Hemodialysis Patients
NCT Number: NCT06481800
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Hemodialysis Complication
Interventions: OTHER: Progressive muscle relaxation (PMR)|OTHER: cnotrol group|OTHER: Manual lymphatic drainage (MLD)
Sponsor: MTI University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 120
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-04-15
Completion Date: 2024-07-21
Locations: Ahmed Mohamed Ahmed Abdelhady, Cairo, Egypt

Summary:
Progressive muscle relaxation versus manual lymphatic drainage on restless leg syndrome and sleep quality in hemodialysis patients

Primary Outcome Measures: International restless legs syndrome rating scale (IRLS), It consists of 10 questions considering different aspects of the impact of RLS on a patient's life. Each question can be answered with a Likert-type scale ranging from "none" (0) to "very severe" (4)., base line and 12 weeks.|Pittsburgh Sleep Quality Index (PSQI), It is a self-report questionnaire that assesses sleep quality. The patient asked to rate his/ her sleep quality, base line and 12 weeks
Secondary Outcome Measures: Leg cramps severity scale, 0 no pain (no early symptoms), 1: mild (under cramps, with early symptoms), 2: discomforting (a cramp, recovery immediate, tolerable), 3: distressing (cramps once or twice, nurse call, recover with some treatment, cramps after HD), 4: horrible and excruciating (several cramps, nurse call, not tolerable, including a cessation of HD, cramps after HD)., base line and 12 weeks|Patient Health Questionnaire (PHQ-9), The (PHQ-9) is efficient, reliable, and highly acceptable for diagnosing depression and anxiety, base line and 12 weeks
Zuojin Wan Combined With Woonosan Fumarate for the Treatment of GRD Combined With Depression
NCT Number: NCT06481787
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Gastroesophageal Reflux Disease|Depression
Interventions: DRUG: Vonorasan Fumarate|DRUG: Zuojin Pills
Sponsor: Nanjing First Hospital, Nanjing Medical University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 300
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-06-30
Completion Date: 2026-06-30

Summary:
To evaluate the improvement of symptoms in patients with gastroesophageal reflux disease combined with depression (hepatic and gastric depression-heat type) by Zuojin Wan combined with vornodine fumarate regimen as a control, and to compare the adherence to the medication and the adverse reactions of the patients between the two groups.

Primary Outcome Measures: Reflux Disease Questionnaire, According to the frequency and severity of episodes of the main symptoms，observe the changes of reflux'disease questionnaire score before treatment and after 8 weeks of treatment., Baseline and 8 weeks|Hamilton Depression Scale, Assessing patients for depressive symptoms, Baseline and 8 weeks|Chinese Medicine Points Scale, Assessment of TCM evidence before and after treatment, Baseline and 8 weeks
Secondary Outcome Measures: Adverse events during treatment, Ask the patient about the occurrence of adverse events while taking the medication, Baseline and 8 weeks
Promoting Access, Resources and Treatment Through Novel and Equitable Solutions for Cancer Care
NCT Number: NCT06481774
Acronym: PARTNERS
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cancer
Interventions: BEHAVIORAL: CONNECT platform
Sponsor: Case Comprehensive Cancer Center
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 375
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-09-01
Completion Date: 2027-06-30
Locations: Case Comprehensive Cancer Center, Cleveland, Ohio, 44106, United States

Summary:
The purpose of this research is to evaluate a novel, integrated approach to providing navigation services to improve cancer outcomes and quality of life.

Primary Outcome Measures: Participant improvement as measured by participant distress screening tool, Participant distress screening assessment tool is a list of questionnaire with a scale from 0-10, where 0 is none and 10 is extreme distress, 4 months|Quality of life as measured by PHQ-9 Patient Depression Questionnaire, Intepretation for PHQ-9 Patient Depression Questionnaire is based on the final score ranging from 1-27, 1-4 is minimal depression, 5-9 is mild, 10-14 is moderate, 15-19 is moderately severe, 20-27 is severe depression, 4 months
Secondary Outcome Measures: The number of social needs as measured by HRSN(Health related social need) questionnaire, HRSN is a list of 19 questions with multiple choice answers with a scale from 1-5 for each question, where 1 is never and 5 is frequently. A score of 11 or more when numerical values for anwers to questions 6-9 are added shows that the person might not be safe., 4 months|Rate of patient satisfaction as measured by cancer care survey, Patient satisfaction with cancer care survey rate based on a scale from 1-5, where 1 is strongly disagree and 5 is strongly agree, 4 months
The Effectiveness of Double-slot Brackets Versus Single-slot Brackets on the Rate of Canine Retraction
NCT Number: NCT06481761
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Rate of Canine Retraction
Interventions: DEVICE: Double-slot brackets|DEVICE: Single-slot brackets
Sponsor: Cairo University
Sex: ALL
Age: CHILD, ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-10
Completion Date: 2025-01
Locations: Cairo University, Giza, 12613, Egypt

Summary:
The aim of this Randomized clinical trial is to compare the efficacy of the double slot brackets compared to single slot-brackets in producing a controlled rate of upper canine retraction into premolar extraction space.

patients will be randomly divided into one of the two groups, CBCT (cone beam computed tomography) and dental models will be taken for each patient Pre-retraction and following the study completion.

The rate of retraction will be evaluated for both groups as well as Amount of canine root movement and molar anchorage loss will be also assessed.

Primary Outcome Measures: rate of canine retraction, millimeters through superimposed digital models taken for each patient monthly at the follow up visits., 3 months
Secondary Outcome Measures: Amount of canine root movement, millimeters through pre and post retraction CBCT (cone beam computed tomography) images of the upper arch, 3 months|Molar cusp anchorage loss, millimeters through superimposed digital models taken for each patient monthly at the follow up visits. and pre and post retraction CBCT images, 3 months