pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Efficacy of Topical 85% TCA in the Treatment of LSIL After Low-grade Abnormality of Screening Test: a Randomized Controlled Trial
NCT Number: NCT06525870
Acronym: Trichlosil
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Cervical Intraepithelial Neoplasia|Trichloroacetic Acid
Interventions: DRUG: 85%TCA topical application|DRUG: 3% acetic acid
Sponsor: Rajavithi Hospital
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 44
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2025-09

Summary:
To determine the efficacy and HPV clearance of an application of 85% TCA compared to placebo in the treatment of LSIL. This is a randomized, single-blind, placebo-controlled study in 44 women aged 18-65 years with histologic-proved HPV/CIN1. The study will test whether 85% TCA application will be effective treatment in LSIL. The clinical study hypothesis is that TCA application at cervical lesion and transformation zone will achieve histologic complete remission of LSIL in significantly more patients than placebo therapy. Patients will be randomized to placebo (3% acetic acid) or 85%TCA topical application at cervical lesion and transformation zone. After 3 months, cytology, colposcopy, histology, and HPV testing will be performed. The primary endpoint is treatment efficacy defined as complete histologic remission at 3 months after treatment. The secondary endpoint is HPV clearance 3 months after treatment. The protocol for the project is approved by an Institutional Review Board (IRB). Project is totally supported by a grant from Rajavithi Hospital. There is no external funding.

Primary Outcome Measures: Complete histologic remission at 3 months, Complete remission (histologic cure) is defined as biopsy-proved normal histology at the time of final colposcopy/biopsy examination at 3-month follow-up., 3 months
Secondary Outcome Measures: Type-specific HPV clearance at 3 months after treatment, Defined as previous type-specific HPV positivity at the initilal assesement become negative at follow-up reassessment visit, 3 months
Observing Physiological Changes in Patients With Long-term Oxygen Therapy
NCT Number: NCT06525857
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Chronic Respiratory Disease
Interventions: OTHER: LTOT
Sponsor: Insel Gruppe AG, University Hospital Bern
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-01
Completion Date: 2026-01-31
Locations: Inselspital, Bern University Hospital, Bern, 3010, Switzerland

Summary:
In this project, the investigators aim to assess changes of physiological parameters obtained non-invasively through PPG and accelerometry signals between before and during LTOT (long-term oxygen therapy) and investigate if those changes are different in patients with worsening frailty and/or improving quality of life.

For this, they will record optical (PPG) and accelerometry data via a datalogger on 40 patients undergoing LTOT and assess the PPG-derived physiological signals.

Primary Outcome Measures: Heart rate changes from before and during LTOT, Record heart rate (BPM) to compare before and during LTOT, From 1 week before start of LTOT to 1 month after start of LTOT|Respiratory rate changes from before and during LTOT, Record respiratory rate (breaths per minute) to compare before and during LTOT, From 1 week before start of LTOT to 1 month after start of LTOT|SpO2 changes from before and during LTOT, Record SpO2 (%) to compare before and during LTOT, From 1 week before start of LTOT to 1 month after start of LTOT
Regenerative Endodontic Therapy in Cases of Irreversible Pulpitis
NCT Number: NCT06525844
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Symptomatic Irreversible Pulpitis
Interventions: PROCEDURE: regenerative endodontic therapy using I-PRF|PROCEDURE: blood clot
Sponsor: Shaheed Zulfiqar Ali Bhutto Medical University
Sex: ALL
Age: ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2025-10-01
Locations: Dr Shahbaz Saqib, Islamabad, ICT, 44080, Pakistan

Summary:
Root canal therapy (RCT) is a classical and effective treatment that is currently utilised in dental practice, offering high success rates for pulp and periapical diseases; however, teeth after RCT are susceptible to altered pulp defence and sensory function, even fractures, as a consequence of pulp loss. Furthermore, several studies have highlighted that the actual failure rate of standard root canal treatments performed in general practice is significantly higher than expected . Moreover, these treatments are lengthy and costly and are often subject to retreatment .Inherent in this procedure(rct) is loss of dental hard tissue and subsequent weakening of the treated tooth,making them more prone to fracture. Therefore, less invasive alternative strategies could be used to treat pulpitis, even when irreversible.

Murray et al. proposed the term "Regenerative endodontic treatment (RET)" in 2007, based on a tissue engineering concept (stem cells, biomimetic scaffolds, and bioactive growth factors). The 2016 American Association of Endodontists (AAE) guidelines formally defined RET as a collection of "biologically based procedures designed to replace damaged tooth structures, including dentine and root structures, as well as cells of the pulp-dentine complex"

Primary Outcome Measures: Success of regenerative endodontics therapy, Success: Defined as clinical and radiographic assessment of the teeth. Clinical examination showed absence of clinical signs of pain and soft tissue pathology (e.g. abscess, sinus tract etc.). Radiographic assessment showed the reduction and/or absence of periapical radiolucency., 12 months
Secondary Outcome Measures: Change in pulp vitality, Change in pulpal vitality will be assessed through pulpal response to sensitivity tests (cold, hot and electrical test) in teeth treated with RET., 1、3、6、12 months
Readers' Attention of Shorter Versus Longer Abstracts of Systematic Reviews
NCT Number: NCT06525805
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Researchers Attention
Interventions: OTHER: Long Abstract|OTHER: Short Abstract
Sponsor: University of Oldenburg
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 6200
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: OTHER
Start Date: 2024-08
Completion Date: 2024-10

Summary:
The present randomized controlled trial (RCT) was designed to investigate the perceptions of researchers on systematic review (SR) abstracts. The primary objective will be to compare readers' attention of shorter versus longer abstracts. The secondary objective will be to assess the perception of an abstract based on four indicators of a well-written abstract: (a) Informativeness, (b) Accuracy, (c) Attractiveness, and (d) Conciseness.

The study will involve researchers from all over the world who recently published an SR, regardless of their research field. To identify eligible authors, a search of MEDLINE (via PubMed) was conducted on May 5, 2024, for systematic reviews published between January 1, 2024, and March 26, 2024. A total of at least 6200 SRs will be selected from PubMed and assessed for eligibility. The corresponding author information will be extracted from all included SRs and randomized in a 1:1 ratio.

Primary Outcome Measures: Trial participation, The primary outcome of this RCT will be the trial participation, which is defined as the proportion of participants who read the abstract and then clicked on the "Continue" button. This will be quantified by dividing the number of participants who read the abstract and proceeded to complete the survey by the total number of individuals who clicked on the link in the email. Information will be electronically captured in SoSci survey., Immediately after reading the abstract
Secondary Outcome Measures: Indicators of a well-written abstract, The secondary outcomes will be four indicators of a well-written abstract, as follows:

1. Informativeness
2. Accuracy
3. Attractiveness
4. Conciseness.

The extent to which participants perceive these criteria to be fulfilled will be quantified on a 4-point Likert scale, e.g. very little informative, little informative, informative, very informative. For data analysis, the data will be dichotomized. For instance, the statements "very little informative" and "little informative" will be summarized in the category "non-informative," while the statements "informative" and "very informative" will be summarized in the category "informative.", Immediately after reading the abstract
Other Outcome Measures: Time needed to read the abstract, The time needed to read the abstract will be quantified. The time interval is defined as the period between the participant clicking on the link in the email and clicking on the "Continue" button to proceed to the survey. This time will be automatically recorded by SoSci Survey., Immediately after reading the abstract
A Clinical Study on Ozone Autohemotherapy for the Treatment of Acute Ischemic Stroke
NCT Number: NCT06525792
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Acute Ischemic Cerebrovascular Disease
Interventions: PROCEDURE: Oxygen|PROCEDURE: Ozone|PROCEDURE: Standard therapy
Sponsor: The First Affiliated Hospital of Zhengzhou University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 62
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2020-08-01
Completion Date: 2022-10-31
Locations: Fifth Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, 450000, China

Summary:
Clinical studies applying ozonated autohemotherapy to treat acute cerebrovascular diseases have validated the safety and efficacy of this treatment, as well as explored its mechanism of action.

Primary Outcome Measures: The expression of SOD(Superoxide dismutase), 7 days
Comparison of Requirement of External Laryngeal Manipulation in Double Lumen Tube Insertion With McGrath Laryngoscope vs Macintosh Laryngoscope. A Randomized Control Trial
NCT Number: NCT06525779
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Intubation Complication
Interventions: DEVICE: Use of macintosh laryngoscope|DEVICE: Use of mcGarth laryngoscope
Sponsor: Shaukat Khanum Memorial Cancer Hospital & Research Centre
Sex: ALL
Age: ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2021-01-25
Completion Date: 2021-07-25
Locations: Shaukat Khanum Memorial Cancer Hospital and Research Center, Lahore, Punjab, 54000, Pakistan

Summary:
For anatomical and physiological isolation of the lung, a specialized endotracheal tube known as the double lumen tube (DLT) is used. The introduction of DLT into anesthesia can be attributed to Carlen's who brought forth the concept in 1949. Since then the structure of DLT has continuously evolved. Simplistically speaking; the double lumen tube is a co-axial tube i.e. it contains two tubes put together, the tube with the shorter length stays in the trachea whereas the tube with the longer length enters the right or left main bronchus. If the proximal or tracheal cuff is inflated, air entry is permitted into both lungs. However, if the distal or the bronchial cuff is inflated, ventilation is directed into either lung depending on which lumen has been clamped, at the proximal end of the tube. Conventionally the DLTs were made of red rubber and were reusable but now they have been replaced by disposable plastic tubes which make it easy to view any secretions or blood. Also, since the plastic makes for a thin wall it allows the lumen of the tube to be large enough to allow airflow with minimal resistance. Larger lumens also allow passage of suction catheters and fiber-optic bronchoscope which serves the purpose of confirming correct position of the double lumen tube after placement. Tracheal intubation with a DLT may be facilitated by maneuvers such as external laryngeal manipulation (ELM). It is a simple technique which has been used by anesthetists since many years to enable intubation. Various types of video-laryngoscopes (VL) have been found to perform a crucial part in patients with difficult airways McGrath video-laryngoscope - a portable machine - provides a better laryngeal view compared to Macintosh laryngoscopy, involving cases of intubation involving patients with normal or difficult airways. Though the use of VL for DLT placement has been reported, such studies have fallen short of producing the desired quality of evidence that is required to make a clear determination in favor of one method over the other. It is suggested that more work is needed on this in order to create a wider, more reliable data pool.

Primary Outcome Measures: Requirement of External Laryngeal Manipulation, Requirement of External Laryngeal Manipulation, 6 MONTHS
Adaptive Therapy With Capecitabine for the Treatment of Metastatic Estrogen Receptor Positive, HER2 Negative Breast Cancer
NCT Number: NCT06525766
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Anatomic Stage IV Breast Cancer AJCC v8|Estrogen-receptor-positive Breast Cancer|Metastatic HER2-Negative Breast Carcinoma|Metastatic Breast Cancer
Interventions: PROCEDURE: Biospecimen Collection|PROCEDURE: Bone Scan|DRUG: Capecitabine|PROCEDURE: Computed Tomography|PROCEDURE: Magnetic Resonance Imaging|OTHER: Questionnaire Administration
Sponsor: Mayo Clinic
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 35
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-10-15
Completion Date: 2029-10-15
Locations: Mayo Clinic in Arizona, Scottsdale, Arizona, 85259, United States

Summary:
This phase II trial evaluates the effect of capecitabine on tumor response using imaging and tumor markers to adjust dose (adaptive therapy) in patients with estrogen receptor (ER) positive, HER2 negative breast cancer that has spread from where it first started to other areas in the body (metastatic). Capecitabine is in a class of medications called antimetabolites. It is taken up by tumor cells and breaks down into fluorouracil, a substance that kills tumor cells. Adaptive therapy with capecitabine based on tumor burden response may slow or stop the growth of tumor cells in patients with metastatic ER positive, HER2 negative breast cancer.

Primary Outcome Measures: Ability to achieve adaptive therapy (AT), Will be assessed by the proportion of patients (%) who are able to receive 2 or more cycles of AT with capecitabine divided by the total number of patients who have entered the AT phase of treatment (have stable or responsive disease)., Up to 5 years
Secondary Outcome Measures: Time to progression, Time to progression will be defined as the time from registration to the earliest date of documentation of disease progression., At registration to disease progression up to 5 years|Overall survival (OS), OS will be defined as the time from registration to death due to any cause., At registration to death up to 5 years|Cumulative dose, The cumulative dose of capecitabine administered per patient will be assessed across patients receiving AT., Up to 5 years|Incidence of adverse events (AEs), The maximum grade for each type of AE will be recorded for each patient. Adverse events will be categorized according to Common Terminology Criteria for Adverse Events (CTCAE) v5.0., Up to 30 days after last dose of study drug|Quality of life - EORTC-QLQ-C30, Will be assessed using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30), a 30-question survey that measures the quality of life of cancer patients. The questionnaire has a score range of 0 to 100 points, with, higher scores indicating a better level of functioning., Up to 5 years
Weaning is Winning? (WeWin Study)
NCT Number: NCT06525753
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Intestinal Failure|Parenteral Nutrition
Interventions: OTHER: Weaning off Parenteral Nutrition
Sponsor: The Hospital for Sick Children
Collaborators: Erasmus MC-Sophia Children's Hospital
Sex: ALL
Age: CHILD, ADULT
Enrollment: 120
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-01
Completion Date: 2034-06-01
Locations: The Hospital for Sick Children, Toronto, Ontario, M5G 1X8, Canada

Summary:
Children with intestinal failure (IF) depend on parenteral nutrition (PN). This is associated with frequent and various complications such as metabolic bone disease, micronutrient deficiencies and abnormal body composition. Due to advancements in care, many patients with IF are able to wean off PN; they are so called PN graduates. It is currently not well known how often complications do occur after weaning off PN, and which patients are at highest risk of developing these complications. We therefore propose a multicenter prospective study on pediatric patients with IF who weaned off PN.

Primary Outcome Measures: Complications, Assess the frequency of nutritional complications including poor growth, micronutrient deficiencies, poor bone health, abnormal body composition, and delayed pubertal development in PN graduates., From 1 year after weaning off PN to 18 years of age
Methadone Versus Intrathecal Hydromorphone for Postoperative Pain Relief in Gynecologic Cancer Undergoing Surgery
NCT Number: NCT06525740
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Malignant Female Reproductive System Neoplasm
Interventions: DRUG: Hydromorphone|DRUG: Methadone|OTHER: Questionnaire Administration
Sponsor: Mayo Clinic
Sex: FEMALE
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 140
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-09-01
Completion Date: 2029-09-01
Locations: Mayo Clinic in Rochester, Rochester, Minnesota, 55905, United States

Summary:
This phase IV trial compares methadone versus hydromorphone given in the fluid-filled space between the thin layers of tissue that cover the brain and spinal cord (intrathecal) for postoperative pain relief in patients with gynecologic cancer undergo surgery. Methadone binds to opioid receptors in the central nervous system and is a long-acting opioid pain medication. Intrathecal hydromorphone works by changing the way the brain and nervous system respond to pain and is similar to an epidural. This trial may help researchers determine if methadone works as well as intrathecal hydromorphone for pain relief after surgery in patients with gynecologic cancer.

Primary Outcome Measures: Difference in pain scores, Will be assessed per group \[intravenous (IV) methadone or intrathecal (IT) hydromorphone\] by patient-reported pain on a scale of 0-10 where 0=no pain and 10=worst pain imaginable., Baseline, upon leaving post-anesthesia care unit (PACU), and at 4, 8, and 12 hours, up to 24 hours postoperatively
Secondary Outcome Measures: Morphine milligram equivalents, Will be assessed by the number of morphine milligram equivalents utilized for the first 24 hours postoperatively., Up to 24 hours postoperatively|Incidence of itching, Will be assessed by the number of patients patient-reported itching on follow-up visits., Up to 24 hours postoperatively|Incidence of respiratory depression, Will be assessed by the number of patients who experience incidents of respiratory depression, defined breathing less frequently as a result of opioid administration., Up to 24 hours postoperatively
Validation of Falls Decision Rule to Exclude Intracranial Bleeding in Geriatric Fall Patients
NCT Number: NCT06525727
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Intracranial Hemorrhages
Interventions: OTHER: Falls Decision Rule
Sponsor: Marmara University
Sex: ALL
Age: OLDER_ADULT
Enrollment: 763
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-01-20
Completion Date: 2025-12-15
Locations: Marmara University Pendik Training and Research Hospital, Istanbul, Pendik, Turkey

Summary:
Although falls are the most important cause of intracranial hemorrhage in the population over 65, studies have shown that bleeding occurs in only 5% of geriatric patients who fall. Guidelines have been developed to assist the clinician in identifying patients at risk of intracranial hemorrhage due to the relatively low incidence but significant morbidity and mortality. The 'Falls Decision Rule' was developed by de Wit et al. in 2023 to assess the need for CT in this patient group. In this study, external validation of this newly developed score was planned to evaluate its safety, applicability, and authenticity.

Primary Outcome Measures: Clinically important intracranial bleeding, The primary outcome is 'clinically significant intracranial hemorrhage' identified within 42 days following the initial presentation in the emergency department. 'Clinically significant intracranial hemorrhage' is defined as hemorrhage within the cranial vault, encompassing subdural, intracerebral, intraventricular, subarachnoid, epidural hemorrhage, and cerebral contusion, necessitating medical or surgical intervention. Medical intervention is defined as any of the following actions: temporary or permanent cessation of anticoagulant or antiplatelet medications; administration of an antifibrinolytic agent; reversal of anticoagulation; or hospitalization for neurological monitoring. These criteria align with those established in the original study., 42 days (Patients will be followed up for 42 days after the fall and evaluated for delayed intracranial haemorrhage).
Effect of HIPEC After Radical Surgery on Long-term Survival for Locally Advanced Gastric Cancer
NCT Number: NCT06525714
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: EARLY_PHASE1
Conditions: Gastric Cancer|Survival Rate
Interventions: DRUG: cisplatin oxaliplatin tegafur
Sponsor: The First Hospital of Jilin University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 302
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2030-07

Summary:
The study focuses on patients with locally advanced gastric adenocarcinoma (cT3N+M0 and cT4aN+/-M0), assessing the feasibility, surgical safety, and oncological benefit of prophylactic HIPEC treatment following laparoscopic D2 radical surgery.

Primary Outcome Measures: 3-year overall survival rate, Three-year overall survival after treatment, Three years after treatment
New Biomarkers and Therapeutic Targets in Osteoporosis Via Omics Technologies
NCT Number: NCT06525688
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Osteoporosis, Postmenopausal|Osteoporosis Fracture|Osteoporosis, Severe
Interventions: OTHER: Bone, Serum and Plasma sample
Sponsor: National and Kapodistrian University of Athens
Collaborators: National Hellenic Research Foundation
Sex: FEMALE
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-03
Completion Date: 2025-12-30
Locations: Laboratory for Research of the Musculoskeletal System, Kifisiá, Attica, 14561, Greece

Summary:
This study aims to discover novel biomarkers and therapeutic targets for osteoporosis through the use of advanced omics technologies, including proteomics and metabolomics. By analyzing bone and plasma samples from patients with osteoporosis, the research seeks to understand the underlying mechanisms of the disease and identify potential diagnostic and therapeutic biomarkers.

Primary Outcome Measures: Identification of Proteomic Biomarkers, The number of proteins identified through proteomic analysis that differ significantly between osteoporosis and control groups, Up to 18 months.|Identification of Metabolomic Biomarkers, The number of small molecules identified through metabolomic analysis that differ significantly between osteoporosis and control groups., Up to 18 months
Secondary Outcome Measures: Bone Density Assessment, Bone density measurements using micro-CT in patients with osteoporosis and controls., Up to 18 months|Identification of Disrupted Pathways, Analysis of disrupted biological pathways using bioinformatics tools to map the mechanisms affected in osteoporosis., Up to 18 months|Correlation of Omics Data with Clinical Markers, Correlation analysis between identified proteomic and metabolomic biomarkers and traditional clinical markers such as CTX and PINP., Up to 18 months|Microarchitecture Assessment, Evaluation of bone microarchitecture using histological analysis in osteoporosis patients and controls., Up to 18 months
Stylet Shape in Simulated Endotracheal Intubation by Medical Students
NCT Number: NCT06525662
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Endotracheal Intubation|Medical Education
Interventions: PROCEDURE: Endotracheal intubation using an endotracheal tube with a 30 degree straight to cuff shape|PROCEDURE: Endotracheal intubation using an endotracheal tube with an arcuate cuff shape
Sponsor: National University Hospital, Singapore
Collaborators: National University of Singapore
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 268
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (CARE_PROVIDER)|Primary Purpose: OTHER
Start Date: 2024-07-10
Completion Date: 2025-12-31
Locations: Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore

Summary:
Endotracheal intubation is a life saving procedure where a tube is placed into a person's windpipe to help them to breathe. This is a study of which shape of tube would lead to improved success in this procedure.

Primary Outcome Measures: Time to successful intubation, Defined as the time between insertion of the laryngoscope to successful placement of the tube in the trachea, Outcome assessment will occur within 2 weeks of endotracheal intubation being taught to participants, and immediately upon randomisation to a specified shape to attempt endotracheal intubation under video recording
Secondary Outcome Measures: Proportion of participants who successfully intubate on first pass of laryngoscope, Defined as successful placement of the tube into the trachea with only one insertion of the laryngoscope blade into the mouth, Outcome assessment will occur within 2 weeks of endotracheal intubation being taught to participants, and immediately upon randomisation to a specified shape to attempt endotracheal intubation under video recording|Proportion of participants who successfully intubate on first pass of endotracheal tube, Defined as successful placement of the tube into the trachea with only one insertion of the endotracheal tube into the mouth, Outcome assessment will occur within 2 weeks of endotracheal intubation being taught to participants, and immediately upon randomisation to a specified shape to attempt endotracheal intubation under video recording|Proportion of participants who perform an oesophageal intubation, Defined as placement of the endotracheal tube into the oesophagus as the end state of the participant's attempt, Outcome assessment will occur within 2 weeks of endotracheal intubation being taught to participants, and immediately after their intubation attempt under video recording
A Double Blind, Randomized, Cross-over Study Examining the Suppression of the Photoparoxysmal EEG Response With NPT 2042
NCT Number: NCT06525649
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Photosensitive Epilepsy|Epilepsy
Interventions: DRUG: NPT 2042
Sponsor: NeuroPro Therapeutics, Inc.
Collaborators: The Epilepsy Study Consortium
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 9
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: OTHER
Start Date: 2024-08-21
Completion Date: 2024-12-30
Locations: Clinical Trials, Inc. (CTI), Little Rock, Arkansas, 77205, United States|Idaho Comprehensive Epilepsy Center, Boise, Idaho, 83702, United States

Summary:
A double-blind, placebo-controlled, crossover trial to investigate the PPR of approximately 5 subjects with a known stable PPR on EEG, using 2 doses of NPT 2042 compared to placebo.

Primary Outcome Measures: Evaluate the change in the adjudicated SPR (standard photosensitivity range), Evaluate the change in the adjudicated SPR (standard photosensitivity range) in subjects receiving each different dose strengths of NPT 2042 compared to placebo in the most sensitive eye condition. The most sensitive eye condition will be determined at the screening visit., Through study completion, an average of 4 months
Secondary Outcome Measures: Change in adjudicated SPR, Evaluate the change in adjudicated SPR in subjects receiving each dose strength of NPT 2042 compared to placebo in all eye conditions., Through study completion, an average of 4 months|Explore the time of PPR effect to the NPT 2042 and metabolite plasma concentration-time profiles in the most sensitive eye condition., Explore the time of PPR effect to the NPT 2042 and metabolite plasma concentration-time profiles in the most sensitive eye condition., Through study completion, an average of 4 months|Explore the onset of PPR effect to the NPT 2042 and metabolite plasma concentration-time profiles in all eye conditions., Explore the onset of PPR effect to the NPT 2042 and metabolite plasma concentration-time profiles in all eye conditions., Through study completion, an average of 4 months|Explore the duration of PPR effect to the NPT 2042 and metabolite plasma concentration-time profiles in all eye conditions., Explore the duration of PPR effect to the NPT 2042 and metabolite plasma concentration-time profiles in all eye conditions., Through study completion, an average of 4 months
Initial Resuscitation for Acute Kidney Injury in Cirrhosis
NCT Number: NCT06525623
Acronym: RAKI-VAGA
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cirrhosis, Liver|Acute Kidney Injury|Hepatorenal Syndrome
Interventions: OTHER: Recommendation: No Further Resuscitation|OTHER: Recommendation: Resuscitation with Crystalloid|OTHER: Recommendation: Resuscitation with Colloid|OTHER: Recommendation: Standard of Care IV Albumin
Sponsor: Massachusetts General Hospital
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07
Completion Date: 2026-03
Locations: Massachusetts General Hospital, Boston, Massachusetts, 02114, United States

Summary:
The goal of this interventional study is to evaluate two strategies for how to provide intravenous (IV) fluids for treating patients with acute kidney injury (AKI) in cirrhosis. The main question it aims to answer is: what is the safety, efficacy, and feasibility of providing a recommendation to use a Volume Assessment Guidance Algorithm (VAGA) or give standard of care doses of IV albumin?

Patients will be randomly assigned where their treating teams will receive a VAGA-based recommendation or a standard of care IV albumin recommendation.

Primary Outcome Measures: IV albumin received (grams), From date of randomization up to 48 hours|Adherence to suggested guidance, For the VAGA group, adherence is defined as: No further resuscitation (\<500 mL total volume of IV fluid given), Resuscitation with crystalloid (\>500 mL total IV fluid given, with \<50 g IV albumin and ≤2 units blood), Resuscitation with colloid (≥50 g IV albumin or ≥2 units blood given). For the Standard of Care group, adherence is defined as receiving within 20% of the suggested IV albumin dose in grams., From date of randomization up to 48 hours|Incidence of treatment-emergent adverse events and serious adverse events, From date of randomization up to hospital discharge, assessed up to 90 days
Secondary Outcome Measures: IV albumin received (grams), From date of hospital admission up to hospital discharge, or the date of time of initiation of renal replacement therapy or liver transplant, whichever came first, assessed up to 90 days.|AKI Response, AKI response is defined as complete response (return of serum creatinine to a value within 0.3 mg/dL of the baseline value), partial response (regression of AKI stage with a reduction of serum creatinine (SCr) to ≥0.3 mg/dl above the baseline value), or no response (neither complete or partial response met)., From date of randomization up to hospital discharge, or the date of time of initiation of renal replacement therapy or liver transplant, whichever came first, assessed up to 90 days.|Vital Status, Alive or dead, From date of randomization up to 90 days|Renal Replacement Therapy Initiation, Yes or No, From date of randomization up to 90 days|Liver transplant, Yes or No, From date of randomization up to 90 days
Weight-Bearing CT Periprosthetic Distal Knee Fractures
NCT Number: NCT06525610
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Periprosthetic Fracture Around Prosthetic Joint Implant Knee
Interventions: OTHER: Periprosthetic Fracture Knee Repaired CT Scans
Sponsor: Lawson Health Research Institute
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 21
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-08
Completion Date: 2025-08

Summary:
Total knee arthroplasty (TKA), a knee implant surgery, is a treatment for end-stage knee osteoarthritis. In some cases, patients suffer an associated periprosthetic fracture, a broken bone that occurs around the implant of a TKA, they may not receive excellent care due to a lack of a trustworthy assessments for fracture healing in the research world. The prevalence of TKA surgeries is increasing annually and is expected to increase further due to an ageing population and obesity issue. By extension to this primary surgery, more Canadians will require an invasive revision surgery that risks patient morbidity and mortality. Thus, it is important to set a standard for fracture stabilization and bone healing assessments to lessen revision burdens and improve patient outcomes. CT imaging is the main clinical tool to evaluate implant stabilization in TKA, which can effectively visualize areas of incomplete bone ingrowth, bone growing into the implant, that may be hidden from overlapping bone and muscle tissue on plain x-rays. The purpose of this prospective study is to examine the efficacy of weight-bearing CT as a diagnostic tool for 21 participants who experienced a distal femur periprosthetic fracture and have underwent revision surgery using a fracture fixation plate and screws, internal splints that hold the bone pieces together. Participants will be scanned under loaded (applying weight on limb) and unloaded conditions. Radiographic outcomes, x-ray imaging from the weight-bearing CT, will be evaluated, including any movement of the bone segments and how they would relate to participants' reports of pain.

Primary Outcome Measures: Weight-Bearing CT Scans, Weight-bearing CT scans of the periprosthetic distal knee fracture that has undergone revision surgery, Scans obtained: <1-week post-operation, 6-weeks, and 1-year|Pain and Function Questionnaires, Pain and function questionnaires that assess the pain and ability-to-function of the knee. These are participant-reported outcomes and they will be compared to the CT scans, <1-week post-operation, 6 weeks, and 1-year
Secondary Outcome Measures: Stool sample, Stool sample collected from participant and analyzed and compared to CT scans for bone healing assessments., 6-week timepoint post-operation
Study of Stapokibart Injection in Patients With Allergic Rhinitis
NCT Number: NCT06525597
Acronym: MIZAR
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Allergic Rhinitis
Interventions: BIOLOGICAL: Stapokibart Injection|DRUG: Placebo
Sponsor: Keymed Biosciences Co.Ltd
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 120
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-10-30
Completion Date: 2025-10-30
Locations: Beijing Tongren Hospital, CMU, Beijing, Beijing, China

Summary:
This study is a Randomized, Double-blind, Placebo-controlled phase II clinical study evaluating the efficacy and safety of Stapokibart injection in patients with allergic rhinitis.

Primary Outcome Measures: Mean change from baseline in daily reflective total nasal symptom scores (rTNSS) over 4 weeks of treatment., The total nasal symptom score (TNSS) is the sum of the four symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing, where each symptom is scored on a scale of 0 to 3., Up to week 4
Ketamine Infusion as a Method of Cerebral Protection in Children
NCT Number: NCT06525584
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Brain Injuries
Interventions: DRUG: Ketamine Hcl 50Mg/Ml Inj|DRUG: Ketamine Hcl 50Mg/Ml Inj|OTHER: Control
Sponsor: Kemerovo State Medical University
Sex: ALL
Age: CHILD
Enrollment: 196
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: PREVENTION
Start Date: 2023-11-05
Completion Date: 2025-12
Locations: Artem Ivkin, Kemerovo, Please Select, 650066, Russian Federation

Summary:
The study is devoted to the use of ketamine infusion in a subanesthetic dose in the postoperative period in children after surgical correction of congenital heart defects in children.

Primary Outcome Measures: Biomarkers, monitoring the concentration of markers of brain damage at several control points, 16 hours after operation
Outcomes of High-risk Non-muscle Invasive Bladder Cancer Treated With Blue Light Resection
NCT Number: NCT06525571
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Bladder Cancer
Interventions: DRUG: Cysview|DEVICE: Karl Storz D-Light C Photodynamic Diagnostic (PDD) system
Sponsor: Johns Hopkins University
Collaborators: Photocure ASA
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-08
Completion Date: 2027-08

Summary:
Comparing white-light cystoscopy (WLC) and blue-light cystoscopy (BLC) in TURBT for high risk (HR) non-muscle invasive bladder cancer (NMIBC) patients is crucial to determine the most effective method for reducing residual disease burden and improving recurrence-free survival. Enhanced visualization with BLC may lead to more accurate resections, potentially decreasing recurrence rates and improving long-term outcomes for bladder cancer patients. Patients will be randomized to either WLC TURBT or BLC TURBT, and outcomes will be measured using standard-of-care testing with cystoscopy and cytology, along with minimal residual disease (MRD) burden evaluation using urine next-generation sequencing.

Primary Outcome Measures: Residual disease burden, The residual tumor burden will be assessed by the standard of care testing, such as cystoscopy and cytology at 3 month intervals., Up to 24 months|Minimal residual disease burden, Minimal residual disease (MRD) in urine will be measured utilizing the Convergent's UroAmp test at 3 month intervals., Up to 24 months
Secondary Outcome Measures: Recurrence-free survival, Recurrence-free survival rate will measured from the date of randomization to the first recurrence or to death from any cause., 24 months
The Presence of Microplastics and Nanoplastics in the Humans Ileum, Colon, and Rectum and Their Relation With Inflammatory Bowel Disease (IBD)
NCT Number: NCT06525558
Acronym: MATISSE
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: IBD
Interventions: PROCEDURE: Intestinal resection
Sponsor: Pierpaolo Sileri
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 102
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-15
Completion Date: 2025-09-30

Summary:
Based on recent studies it is hypothesized that microplastics and nanoplastics (MNPs) are present in human's ileum, colon, and rectum and that their presence may have a correlation with Inflammatory Bowel Disease (IBD).

This study is a cross-sectional, single-center, non-profit observational study. The main objectives are to define in vitro the presence of MNPs in the humans ileum, colon, and rectum and to evaluate if there is a correlation between this presence and IBD. In vitro metabolomics and proteomics analyses of the study sample and the assessment of participants' daily plastic exposure are considered exploratory objectives. For this purpose, a total of 102 patients undergoing a surgery where intestinal resection is included, will be enrolled.

Primary Outcome Measures: Determination of the presence of microplastics and nanoplastics in the humans ileum, colon, and rectum., The variables for evaluating the primary objective:

- Monomer Type and characterization:

* Type
* Concentration, Baseline/Time zero
Secondary Outcome Measures: Evaluation of the possible correlation between the presence of the microplastics and nanoplastics in the humans bowel and Inflammatory Bowel Disease (IBD)., To determine this correlation, the participants will be divided in two groups:

1. IBD Group: Participants with IBD

   * Crohn disease (n=26)
   * Ulcerative Colitis (n=25)
2. Non IBD Group: Participants with other diseases that are not IBD (for example, tumor, rectal prolapse or diverticulitis)

The data collected from the two groups will be compared and evaluated using appropriate statistical methods., Baseline/Time zero
Other Outcome Measures: Analysis of further characteristics of the study sample such as the metabolomics and proteomics characteristics and assessment of participants' daily plastic exposure., Since the presence of MNPs might influence the primary metabolomic pathways and lead to modifications in the proteomic profiling of tissues, metabolomics and proteomics analyses will be performed to comprehensively assess any possible alteration resulting from the presence of these particles.

Furthermore, participants' daily plastic exposure will be assessed through the 10-minute questionnarie questions defined in the "Baseline Questionary" supporting document, related to their dietary habits., Baseline/Time zero
Clinical-MRI Evaluation in Patients Undergoing Subtalar Arthrorisis With Reabsorbable Endorthesis Implant in PLLA
NCT Number: NCT06525532
Acronym: CS-RM
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Lower Limb Deformity
Interventions: OTHER: follow up
Sponsor: Istituto Ortopedico Rizzoli
Sex: ALL
Age: CHILD
Enrollment: 35
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-12
Completion Date: 2025-12
Locations: Istituto Ortopedico Rizzoli, Bologna, 40136, Italy

Summary:
From the archives of the IRCCS Rizzoli Orthopedic Institute, all cases of arthrorrhesis of the subtalar joint with a reabsorbable endorthotic implant in PLLA will be retrieved. An overall electronic database will be created and all medical records of these cases will be reviewed.

The eligibility of each individual patient will be assessed on the basis of the exclusion and inclusion criteria (non-probability convenience sampling).

The study will not present a control group or comparison groups between therapeutic procedures.

Primary Outcome Measures: Instrumental evaluation, Instrumental evaluation with 3 Tesla MRI of the degradation and possible resorption of the implant, At baseline (Day 0)|evaluation of screw resorption, Clinical and Magnetic Resonance Imaging Results - PMC (nih.gov), Poly-L-lactic acid - hydroxyapatite (PLLA-HA) bioabsorbable interference screws for tibial graft fixation in anterior cruciate ligament (ACL) reconstruction surgery, at baseline
Secondary Outcome Measures: clinical evaluation - Ankle-Hindfoot score, AOFAS: this questionnaire consists of points assigned to nine items divided into three categories: pain (40 points), functional aspects (50 points) and alignment (10 points) for a total of 100 points, the extreme of which represents a normal foot complex -ankle, at baseline (day 0)|Quality of life - SF-12, The SF-12 health questionnaire is a standardized generic instrument for the rapid, economical and disease-free acquisition of the patient's health-related quality of life., at baseline
Comparison of Different Dose of Anti-T Lymphocyte Globulin (ATLG) in Haploidentical HSCT for GVHD Prophylaxis
NCT Number: NCT06525519
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Hematopoietic Stem Cell Transplantation
Interventions: DRUG: ATLG|DRUG: ATLG
Sponsor: Institute of Hematology & Blood Diseases Hospital, China
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 104
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-31
Completion Date: 2026-07-31
Locations: The Southwest Hospital of Amu, Chongqing, Chongqing, 400000, China|Fujian Medical University Union Hospital, Fuzhou, Fujian, 350001, China|The First Bethune Hospital of Jilin University, Jilin, Jilin, 1340000, China|Tai'an City Central Hospital, Taian, Shandong, 271000, China|People's Liberation Army The General Hospital of Western Theater Command, Chengdu, Sichuan, 610083, China

Summary:
This study aims to compare the incidence of graft-versus-host disease (GVHD) in haploidentical hematopoietic stem cell transplant recipients who receive varying doses of anti-T lymphocyte globulin (ATLG) for GVHD prophylaxis. Our primary objective is to determine the optimal dose of ATLG for preventing acute GVHD (aGVHD). Additionally, we plan to evaluate the impact of different doses of ATLG on post-transplant viral infections and other clinical outcomes.

Primary Outcome Measures: Incidence of grade II-IV acute Graft Versus Host Disease (GVHD), aGVHD was graded according to standard criteria, At day 100 post-transplantation
Secondary Outcome Measures: Incidence of moderate to severe chronic GVHD (cGVHD), Chronic GVHD was assessed in patients alive after day 100. cGVHD was graded according to standard criteria., 1 year|Incidence of Epstein-Barr virus(EBV) viremia, Incidence of EBV viremia within 180 days, 180 days|Survival without relapse and moderate to severe GVHD, Rate of patients remain alive without disease relapse or progression (bone marrow blast \>5% or extra medullary diseases) and without documentation of grade III-IV acute GVHD and moderate to severe chronic GVHD, 1 year