pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Nasoseptal Double Flap Versus Rescue Flap in Endoscopic Transsphenoidal Pituitary Surgery
NCT Number: NCT06526481
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Pituitary Adenoma
Interventions: PROCEDURE: Endoscopic Transsphenoidal pituitary surgery : Double Nasoseptal Flap Technique|PROCEDURE: Endoscopic Transsphenoidal pituitary surgery : Rescue Flap Technique
Sponsor: Mansoura University
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 56
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2022-12-12
Completion Date: 2024-07-01
Locations: Mansoura University, Department of otorhinolaryngology, Mansoura, Egypt

Summary:
This paper investigates the outcomes of two surgical techniques-nasoseptal double flap and nasoseptal rescue flap-used in endoscopic transsphenoidal surgery for pituitary tumors. The nasoseptal flap technique has significantly reduced the incidence of postoperative Cerebrospinal Fluid (CSF) leaks but can cause nasal morbidity.

Primary Outcome Measures: Nasal morbidity, Sinonasal Outcome Test 22 (SNOT-22) arabic translation questionnaire for nasal morbidity SinoNasal Outcome Test - 22 abbreviated (SNOT-22) includes 22 items for assessment by the patient. Each item is graded from 0 to 5. The minimum score is 0. The maximum score is 110. High score means higher nasal morbidity. Low scores mean better nasal morbidity., at baseline preoperative and 1 month and 3 months postoperative.
Secondary Outcome Measures: Operative data, Operative time, at time of surgery
Chinese PE Multimodality Imaging Artificial Intelligence Study
NCT Number: NCT06526468
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Pulmonary Embolism|Chronic Thromboembolic Pulmonary Hypertension|Chronic Thromboembolic Pulmonary Disease
Interventions: DEVICE: Artificial Intelligence
Sponsor: China-Japan Friendship Hospital
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 1500
Study Design: Observational Model: |Time Perspective: p
Start Date: 2010-09-01
Completion Date: 2028-09-01
Locations: China-Japan Frendship hospital, Beijing, 100029, China

Summary:
The CHinese pulmOnary Embolism Multimodality Imaging-artifiCial intelligencE Study (CHOICE) is a prospective observational multi-center study that will collect imaging text data and raw data of patients with pulmonary embolism (PE) in China. By combining artificial intelligence technology, it aims to identify imaging markers to assist in early diagnosis, differential diagnosis, risk stratification, and prognosis assessment of PE.

Primary Outcome Measures: Diagnostic rate of PE, Comparison before and after AI technique., 2 years|APE risk stratification rates (low, intermediate low, intermediate high and high risk), Comparison before and after AI technique., 2 years|Disease severity of chronic thromboembolic pulmonary disease (CTEPD)/chronic thromboembolic pulmonary hypertension (CTEPH), Comparison before and after AI technique. Assessment of disease severity is comprehensive, referring to the comprehensive risk assessment in pulmonary arterial hypertension (three-strata model) \[DOI: 10.1183/13993003.00879-2022\], including clinical observations and modiﬁable variables. The higher the score, the more severe the condition., 2 years|30 day mortality, Patient mortality (death) at 30-days post-PE diagnosis. Comparison before and after AI technique., 2 years
Secondary Outcome Measures: Rate of discordant PE cases, False positive and false negative rate, 2 years|AI failure rate for PE detection, Proportion of scans unable to be interpreted by AI despite suitable CTPA acquisition, 2 years|12 month mortality, Patient mortality (death) at 12-months post-PE diagnosis. Comparison before and after AI technique., 2 years|Length of hospital stay for PE, Comparison before and after AI technique. Measured as number of days from admission to time of discharge from hospital., 2 years|Time from symptom onset to final diagnosis, Comparison before and after AI technique., 3 months|Hospitalization cost for PE using Markov model, Comparison before and after AI technique., 2 years
MRE for Diagnosis of Pancreatic Masses
NCT Number: NCT06526442
Acronym: MREDPCM
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Pancreatic Neoplasm|Magnetic Resonance Imaging
Interventions: DIAGNOSTIC_TEST: magnetic resonance imaging
Sponsor: Yu Shi
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-06-01
Completion Date: 2026-06-01
Locations: Shengjing hospital of china medical university, Shenyang, Liaoning, 110004, China

Summary:
Pancreatic ductal adenocarcinoma (PDAC) accounts for 85-95% of pancreatic cancer and is one of the deadliest tumors in the world, with a survival rate of less than 8%, and identifying key prognostic or predictive factors facilitates risk stratification and prospective assessment in clinical trials. The extracellular matrix (ECM) surrounding PDAC often exhibits a large number of interstitial fibrosis, which is closely related to the formation, development and metastasis of PDAC. High order three-dimensional MR elastography (3D-MRE) allows non-invasive measurements of sheer stiffness in normal pancreas and pancreatic lesions. However, there are no reports about the application of MRE imaging biomarkers to predict the prognosis of PDAC at home and abroad.

Primary Outcome Measures: Analyzing the measurement accuracy of MRE., The hardness was measured by a hardness tester during the operation, and the mechanical parameters were measured by atomic force microscopy of the in vitro specimen. The measurement accuracy of MRE was analyzed by comparing the hardness tester and atomic force microscope results., 9 months|Radiological assessment of tumor stiffness., A self-written script program in MATLAB is used to read and analyze mechanical group diagrams and waveform diagrams in three directions of x, y, and z, and a region of interest (ROI) delineation function is embedded.After drawing the ROI, an Excel file containing the corresponding values is automatically generated, and the average values of various mechanical parameters are calculated, including shear modulus (\|G\*\|, SS), storage modulus (G', SM), loss modulus (G'', LM) and damping ratio (ӡ, DR)., 9 months|Evaluation of tumor response to chemotherapy., RECIST criteria (version 1.1) were used to objectively evaluate the response to chemotherapy., 12 months
Local Ischemic Postconditioning in Acute Ischemic Stroke
NCT Number: NCT06526429
Acronym: RAPID-SAVEI
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Acute Ischemic Stroke|Mechanical Thrombectomy|Ischemic Postconditioning|Brain Edema|Neuroprotection
Interventions: PROCEDURE: rapid local ischemic postconditioning
Sponsor: Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Collaborators: Zhangzhou Municipal Hospital of Fujian Province|Shanghai East Hospital|RenJi Hospital|First People's Hospital of Hangzhou
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-15
Completion Date: 2026-01-31
Locations: Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, 200023, China|Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, 200233, China

Summary:
This study aims to determine the safety and optimal dose of rapid local ischemic postconditioning in acute ischemic stroke(AIS) patients received successful thrombectomy reperfusion. In this trial, investigators will halt antegrade cerebral blood flow temporarily by the way of balloon guiding catheter (BGC) inflation/deflation in AIS patients immediately after revascularization. It makes the ischemic reperfusion brain tissue have a capacity of adaptation through intermittent blood flow restoration. The optimal postconditioning intervention dose will be determined for further investigation.

Primary Outcome Measures: Incidence of Treatment-Emergent Adverse Events, Treatment-Emergent Adverse Events including any one of below:

1. Malignant middle cerebral artery infarction defined as midline shift ≥5 mm at the level of septum pellucidum, or anisocoria attributable to herniation, or death attributable to herniation.
2. Complications related to ischemic postcondition intervention that require treatment including distal vascular embolism, local arterial dissection, and local vascular spasm at the intervention site of the internal carotid artery.
3. Other causally attributable serious adverse events (SAEs), within 7 days
Other Outcome Measures: Incidence of mitigation on infarction growth, Mitigation on infarction growth defined as infarction growth\<10 mL from baseline to 72 hours, 72 hours after procedure
The Objective is to Evaluate the Anterior Chamber Angle After BANG Procedure, the Study Will Recruit 12 Patients Who Will Undergo Planned Goniectomy for Uncontrolled POAG, Anterior Segment OCT Scan Will Be Used to Evaluate the Anterior Chamber Postoperatively.
NCT Number: NCT06526416
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Primary Open Angle Glaucoma|Glaucoma
Sponsor: Benha University
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 12
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-11-01
Completion Date: 2025-01-01

Summary:
Evaluation of anterior segment using anterior segment optical coherence tomography in patients undergoing planned bent angle needle goniectomy procedure for uncontrolled open angle glaucoma.

Primary Outcome Measures: To detect the changes in anterior chamber angle using Anterior segment OCT after BANG goniectomy, To detect the changes in anterior chamber angle using Anterior segment OCT after BANG goniectomy, 12 weeks after the day of surgery.
Secondary Outcome Measures: To detect any correlation between the post-op anterior chamber angle changes and the intraocular pressure., To detect any correlation between the post-op anterior chamber angle changes and the intraocular pressure., 12 weeks after the day of surgery.
Echocardiography-guided Oval-shaped ASD Closure
NCT Number: NCT06526403
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: ASD II|Percutaneous Closure|Zero-fluoroscopy
Interventions: DEVICE: Zero-fluoroscopy ASD closure
Sponsor: National Cardiovascular Center Harapan Kita Hospital Indonesia
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 78
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2018-07-14
Completion Date: 2023-05-30
Locations: National Cardiovascular Center Harapan Kita, Jakarta, 11420, Indonesia

Summary:
Background: An atrial septal defect (ASD) is considered oval-shaped when its shortest diameter is less than 75% of its longest diameter. Research on the percutaneous closure of oval-shaped ASDs is limited, and to our knowledge, there are no reports of non-fluoroscopic closure for this specific population.

Objective: To assess the effectiveness of non-fluoroscopic percutaneous closure for oval-shaped ASDs.

Methods: This single-center, retrospective study examines patients undergoing percutaneous closure of oval-shaped ASDs using a non-fluoroscopy technique for initial decision-making. The device was selected to be approximately 0-4 mm larger than the longest diameter of the defect, based on measurements from transthoracic and transesophageal ultrasound.

Primary Outcome Measures: Success rate, five years
Adjuvant IP-001 Treatment for HCC Patients Following Surgical Resection and Ablation or Ablation Alone
NCT Number: NCT06526338
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Hepatocellular Carcinoma
Interventions: DRUG: 1.0% IP-001 for injection|PROCEDURE: Surgical Resection and Local Ablation|PROCEDURE: Local Ablation Alone
Sponsor: Robert C. Martin
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 126
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-24
Completion Date: 2030-12
Locations: University of Louisville, Louisville, Kentucky, 40202, United States

Summary:
The purpose of this study is to evaluate the safety and efficacy of a single injection of IP-001 as adjuvant therapy after local ablation or surgical resection and ablation in patients with hepatocellular carcinoma (HCC).

Primary Outcome Measures: Recurrence Free Survival, Radiological assessments (Triphasic CT or MRI) of the chest, abdomen and pelvis will occur every 12 weeks for the first 2 years, then every 24 weeks thereafter. Recurrence will be determined by the investigator's radiological review per RECIST v1.1, From Date of Randomization until date of documented progression, assessed up to 60 months
Secondary Outcome Measures: Cancer Free Survival, Participants will be followed every 12 weeks from treatment Day 1 for the first 2 years, and every 24 weeks thereafter until disease related death., Months 12 and 24|Overall Survival, Participants will be followed every 12 weeks from treatment Day 1 for the first 2 years, and every 24 weeks thereafter until death of any cause., Months 12 and 24|Overall Survival Rate, Proportion of participants who have not experienced death from treatment Day 1 at 12 and 24 months after treatment., Months 12 and 24|Recurrence Free Survival Rate, Assessed from treatment Day 1 to documentation of disease recurrence or extrahepatic) or death, whichever occurs first., Months 12 and 24|Time to Intrahepatic Tumor Recurrence, Radiological assessments (Triphasic CT or MRI) of the chest, abdomen and pelvis will occur every 12 weeks for the first 2 years, then every 24 weeks thereafter. Recurrence will be determined by the investigator's radiological review per RECIST v1.1, From Date of Randomization until date of documented progression, assessed up to 60 months|Time to Extrahepatic Tumor Recurrence, Radiological assessments (Triphasic CT or MRI) of the chest, abdomen and pelvis will occur every 12 weeks for the first 2 years, then every 24 weeks thereafter. Recurrence will be determined by the investigator's radiological review per RECIST v1.1, From Date of Randomization until date of documented progression, assessed up to 60 months
Clinical Decision Support to Increase Use of Medications for Opioid Use Disorder
NCT Number: NCT06526286
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Medication Abuse|Harm Reduction|Opioid Use Disorder
Interventions: OTHER: Medications for Opioid Use Disorder Pathway Clinical Decision Support (CDS)
Sponsor: University of Colorado, Denver
Collaborators: National Institutes of Health (NIH)|National Institute on Drug Abuse (NIDA)
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 200000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-10
Completion Date: 2026-10

Summary:
The objective of this study is to evaluate the impact of clinical decision support (CDS) in the form of an alert to identify patients who may be at risk of opioid use disorder (OUD) and a clinical care pathway helping providers treating patients with opioid use disorder. The pathway provides health care providers with information and suggestions for screening and treatment of opioid use disorder, including treatment with medications. The 2022 Centers for Disease Control and Prevention (CDC) clinical practice guideline for prescribing opioids for pain recommends providers asses for and treat opioid use disorder using approved medications for opioid use disorder (MOUD). This project will randomize primary care providers at the clinic level to a control arm or intervention arm. The control arm will have access to the clinical care pathway, but will not be reminded to utilize the pathway when treating a patient with opioid use disorder. The intervention arm will receive a reminder nudge about the pathway. Buprenorphine (a medication used to treat opioid use disorder) prescribing behavior of providers and outcomes of patients will be examined based on medical records data collected during routine care. The study period will be approximately 18 months.

Primary Outcome Measures: Percentage of patients at risk for opioid use disorder receiving medications for opioid use disorder, The number of primary care patients identified to be at risk for opioid use disorder treatment with buprenorphine for treatment divided by the total number of patients meeting opioid use disorder criteria, 18 months
Secondary Outcome Measures: Clinical decision support (CDS) acceptance rate, The number of times providers accepted the clinical decision support (CDS) tool and utilized the clinical care pathway in treating opioid use disorder., 18 months|Subsequent opioid overdose/poisoning rates, The number of patients who had a diagnosis of opioid overdose or poisoning, Six months after an encounter where the opioid use disorder is identified|Buprenorphine initiation, Number of patients who filled a buprenorphine prescription after being identified at risk., Six months after an encounter where the opioid use disorder is identified
Performance of Non-injected MR Enterography Compared to a Conventional MR Enterography Protocol With Contrast Agent Injection
NCT Number: NCT06526234
Acronym: Fast-MR
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Crohn Disease
Interventions: DEVICE: MRI
Sponsor: Central Hospital, Nancy, France
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 500
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-23
Completion Date: 2025-07-23
Locations: CHRU Nancy, Vandœuvre-lès-Nancy, CHRU De Nancy, 54511, France

Summary:
Entero-MRI is indicated in Crohn's disease as part of the initial work-up or follow-up (to assess response to treatment, complications). The protocol for carrying out the examination complies with precise specifications set out in international recommendations. To perform the test, the small intestine must be distended with a hyperosmolar product. This protocol is applied to all patients, with no distinction or adaptation.

The total duration of the examination is sometimes difficult for patients to bear. Ingestion of the product to obtain distension of the small intestine is often poorly tolerated by patients.

In a number of cases, the entero-MRI may have been normal due to symptomatology regression or other diagnosis. The patient therefore underwent a complete examination similar to that of a patient with a pathology requiring characterization.

In this context, the investigators hypothesize that fast MR sequences are sufficient to discriminate between normal and abnormal examinations.

Primary Outcome Measures: Presence or absence of lesions detected visually by a radiologist on injection-free sequences versus conventional MR enterography., Baseline (day 0)
Investigating a Marijuana-based Compound as a Treatment for Anxiety in Autistic Adults
NCT Number: NCT06526208
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Autism Spectrum Disorder|Anxiety
Interventions: DRUG: MB-IMP|OTHER: Placebo
Sponsor: Southwest Autism Research & Resource Center
Sex: ALL
Age: ADULT
Enrollment: 108
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-10-01
Completion Date: 2027-09-30
Locations: Southwest Autism Research and Resource Center, Phoenix, Arizona, 85006, United States

Summary:
The goal of this clinical trial is to learn if drug ABC works to treat severe asthma in adults. It will also learn about the safety of drug ABC. The main questions it aims to answer are:

Will a marijuana-based drug help anxiety in autistic adults?

Anxiety can make socializing and working more difficult for people. Researchers will compare a marijuana based drug (that is mostly CBD with a small amount of THC) to a placebo (a look-alike substance that contains no drug) to see if the drug makes symptoms of anxiety better.

Participants will take the drug (or a placebo) every day for 8 weeks and keep a diary to record the time they took the drug, and their feelings each day. The drug is taken orally in drops once or twice a day. The study staff will speak to the participants weekly either over the phone or in the clinic. Clinic visits once every 2 weeks for checkups and tests. The researchers will make sure participants are healthy and see if there are any changes in anxiety.

Primary Outcome Measures: Change in baseline on reported anxiety related symptoms, The Clinical Global Impression Scale for Severity will be used to measure the change in anxiety related symptoms. We hypothesize a two point reduction in severity and, 8 weeks
Secondary Outcome Measures: Change in socialization, We will measure the Change in behaviors related to socialization with the Social Responsiveness Scale, 8 weeks|Change in repetitive behaviors from baseline to the end of study, We will measure the amount of repetitive behaviors with the Repetitive Behavior Scale- Revised, 8 weeks.|We will measure the change in a variety of aberrant behaviors from baseline to end of study, Study partners will complete the Aberrant Behavior Checklist at every clinic visit., 8 weeks
Assessment of Human Exposure to Chemical Hazards
NCT Number: NCT06526169
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Dietary Exposure
Interventions: OTHER: Food Frequency, Social, Lifestyle, Demographic Questionnaires and Blood Collection
Sponsor: National University of Singapore
Collaborators: Singapore Food Agency
Sex: ALL
Age: ADULT
Enrollment: 300
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-01
Completion Date: 2027-07-31
Locations: National University of Singapore, Singapore, 118177, Singapore

Summary:
The aim of this study is to evaluate the occurrence of chemical hazards exposure in the Singapore population and assess their association with food consumption.

Primary Outcome Measures: Chemical hazards occurrence, To evaluate the occurrence of chemical hazards exposure in the Singapore population and assess their association with food consumption., 3 years
Influence of Anaesthesia Type on Multiple Sclerosis Relapse
NCT Number: NCT06526130
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Multiple Sclerosis
Interventions: PROCEDURE: General anaesthesia|PROCEDURE: Neuraxial anaesthesia
Sponsor: Varazdin General Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 56
Study Design: Observational Model: |Time Perspective: p
Start Date: 2012-01-01
Completion Date: 2024-05-16

Summary:
The influence of anesthesia on the course of multiple sclerosis is poorly investigated and the literature is limited.

The aim of this study is to investigate multiple sclerosis relapse after different types of anesthesia.

Primary Outcome Measures: Multiple sclerosis relapse after 1 month, Overall incidence of multiple sclerosis relapse after 1 month after anaesthesia, 1 month|Multiple sclerosis relapse after 3 months, Overall incidence of multiple sclerosis relapse after 3 months after anaesthesia, 3 months|Multiple sclerosis relapse after 6 months, Overall incidence of multiple sclerosis relapse after 6 months after anaesthesia, 6 months|Multiple sclerosis relapse after 12 months, Overall incidence of multiple sclerosis relapse after 12 months after anaesthesia, 12 months
Stroke Prevention in Nigeria 2 Trial
NCT Number: NCT06526117
Acronym: SPRING-2
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Sickle Cell Disease|Stroke
Interventions: DRUG: Hydroxyurea
Sponsor: Vanderbilt University Medical Center
Collaborators: Aminu Kano Teaching Hospital|Murtala Muhammed Specialist Hospital|National Institute of Neurological Disorders and Stroke (NINDS)
Sex: ALL
Age: CHILD
Enrollment: 220
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-08-05
Completion Date: 2030-06-30
Locations: Aminu Kano Teaching Hospital, Kano, Nigeria|Murtala Muhammad Specialist Hospital, Kano, Nigeria

Summary:
The primary goal of this study is to complete a multicenter single-arm, type I hybrid trial to assess the effectiveness of hydroxyurea therapy for primary stroke prevention in high-risk children with sickle cell anemia (SCA) living in Nigeria in routine care settings.

Primary Outcome Measures: Incidence Rate of Clinical Stroke or TIA, The incidence rate of clinical stroke or TIA in participants treated with low- or moderate-dose hydroxyurea., 5 years
Secondary Outcome Measures: Incidence of All-Cause Hospitalizations, To evaluate all-cause hospitalizations with low-dose or moderate-dose hydroxyurea during clinic visits. Participants will be interviewed to determine the number of interim hospitalizations., 5 years
Cerebral Oxygen Saturation Monitoring During Optimum Cord Management in Preterm Infants
NCT Number: NCT06526091
Acronym: COSMIC
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Pre-Term
Interventions: OTHER: Cerebral NIRS monitoring at delivery
Sponsor: Imperial College Healthcare NHS Trust
Sex: ALL
Age: CHILD
Enrollment: 40
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-02-15
Completion Date: 2024-10-01
Locations: Imperial College Healthcare NHS Trust, London, United Kingdom

Summary:
This study will assess the feasibilty measuring cerebral oxygen saturations using a Near Infrared Spectroscopy (NIRS) monitor immediately after delivery of preterm infants. The investigators aim to evaluate the effects of optimum cord management on cerebral oxygenation in this cohort

Primary Outcome Measures: Feasibility of regional cerebral saturation (rSO2 in %) monitoring using NIRS during optimum cord, Feasibility of regional cerebral saturation (rSO2 in %) monitoring using NIRS during optimum cord management in preterm infants, 2 years
Secondary Outcome Measures: Arterial saturation (SaO2 in %) monitoring, Evaluating the effect of optimum cord management on SaO2, 2 years|Oxygenation (FiO2 in %) during stabilisation, Evaluating the effect of preterm stabilisation including optimum cord management on FiO2 (%), 2 years
Molecular Mechanisms in Malignant Lymphoma- Predict (MMML Predict)
NCT Number: NCT06526065
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: DLBCL - Diffuse Large B Cell Lymphoma
Interventions: OTHER: no intervention
Sponsor: University Medical Center Goettingen
Collaborators: Charite University, Berlin, Germany|Wuerzburg University Hospital|University Hospital Ulm|University of Leipzig|University Hospital Regensburg|University Hospital Freiburg|Robert Bosch Hospital Stuttgart|University of Kiel|University Hospital, Essen
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 500
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-20
Completion Date: 2029-06-01
Locations: Universitätsmedizin Göttingen, Göttingen, Lower Saxony, 37075, Germany

Summary:
The trial aims at the construction and validation of an accurate, affordable and simple prognostic tool to be used in everyday clinical practice, which allows the early and reliable identification of DLBCL patients who have a very high risk of treatment failure following R-CHOP/-like first-line therapy.

Primary Outcome Measures: Progression-free Survival (PFS-2) with 95% confidence intervals, PFS is defined as the time from the day of inclusion into the observation trial through one of the following events, whichever comes first:

* Change of treatment due to response in iPET (PD - Progressive Disease)
* Disease progression
* Relapse
* Death due to any cause Patients without event at the time of analysis will be censored at the most recent date of disease assessment., 2 years
Secondary Outcome Measures: Overall Survival (OS), Overall Survival (OS) is defined as the time from the day of inclusion into the observation trial to death due to any cause; patients without event will be censored at the last date known to be alive., 5 years|Event-free survival (EFS), Event-free survival (EFS) is defined as the time from the day of inclusion into the observation trial through one of the following events, whichever comes first:

* Change of treatment due to response in iPET (PD)
* Disease progression
* Start of additional, unplanned anti-lymphoma therapy (consolidation radiotherapy as per S3LL excluded)
* Relapse
* Death due to any cause, 5 years|Response rates, overall response to treatment, 2 years|Safety and toxicity, treatment side effects, 5 years
An Innovative Mental Health Virtual Ward: Evaluation of Patient-Centered Outcomes
NCT Number: NCT06526026
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Mental Health Disorder|Mental Health Impairment|Psychiatric Emergency|Crisis; Emotional
Interventions: BEHAVIORAL: Virtual crisis stabilization support with a multi-disciplinary team
Sponsor: University of Manitoba
Collaborators: Health Sciences Centre Foundation, Manitoba
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 476
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-22
Completion Date: 2026-12-31
Locations: Crisis Stabilization Unit, Winnipeg, Manitoba, R3G 0N2, Canada

Summary:
The goal of this study is to evaluate if admission to the Mental Health Virtual Ward (MH vWard) for mental health crisis stabilization is having a meaningful positive impact on patient reported outcomes and healthcare utilization. The objectives of this study are:

1. Prospectively measure demographic, recovery, service delivery, and systems use outcomes in a cohort of MH vWard admissions.
2. establish this cohort for use in future research.

As part of the intervention, participants will receive care in the MH vWard for an average of 5 days following a visit to an emergency department or crisis centre for a mental health crisis. While admitted to the MH vWard, participants will:

1. Engage in individual therapy and care planning with a clinician or psychiatry team.
2. Have engagement with formal (community providers) and informal supports (family, friends) for collateral and collaboration.
3. Receive medication reconciliation and management.
4. Participate in group programming.
5. Receive referrals for follow-up services.
6. Have access to after hours support.
7. Have access to the Telus Home Health Monitoring (HHM) App, which is custom designed to complement the services provided by the program.

Primary Outcome Measures: WHO-5 Well-Being Index, Wellbeing, 1 week, 5 weeks and 6 months from date of discharge
Secondary Outcome Measures: Healthcare utilization - self report (all participants), Systems use outcomes will include: emergency department visits, crisis centre visits, psychiatric hospitalizations collected by self report, 1 week post discharge, 5 weeks post discharge and 6 months from date of discharge|Healthcare utilization - administrative data (urban participants only), Systems use outcomes will include: emergency department visits, crisis centre visits, psychiatric hospitalizations collected via healthcare administrative data, 1 week post discharge, 5 weeks post discharge and 6 months from date of discharge|Maryland Assessment of Recovery Scale-12, Recovery, 1 week post discharge, 5 weeks post discharge, 6 months post-discharge
Cholesterol Self-testing in Patients Post Acute Coronary Syndrome
NCT Number: NCT06526013
Acronym: C-Check
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Acute Coronary Syndrome|Prevention|LDL Hyperlipoproteinemia|Therapeutic Adherence
Interventions: OTHER: Cholesterol self-measurement
Sponsor: University of Leipzig
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-06-01
Completion Date: 2025-09-30
Locations: Clinic of cardiology University clinic Leipzig, Leipzig, Saxony, 04103, Germany

Summary:
The pharmacological reduction of LDL-C lowers cardiovascular risk and is therefore a priority in cardiovascular secondary prevention. The achievement of LDL-C target levels in Germany, Europe, and worldwide is inadequate, despite a wide array of lipid-lowering medications. Only a small proportion of post-myocardial infarction patients reach their LDL-C target range within a year. There is a significant need for new strategies to improve LDL-C target achievement and thereby reduce the occurrence of secondary cardiovascular events.

The aim of the study is to establish a basis for improving prevention by achieving the target LDL level effectively and quickly in patients with high and very high cardiovascular risk profiles.

Primary Outcome Measures: percentage value LDL-Cholesterol reduction in comparison to baseline, Compare the change in value of LDL-Cholesterol with additional monthly self measurement of parameters after 6 months versus baseline and the control group., 6 months
Study to Assess Changes in Immunoglobulins in Patients With Relapsing Multiple Sclerosis Treated With Anti-CD20 Therapies
NCT Number: NCT06526000
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Relapsing Multiple Sclerosis|Clinically Isolated Syndrome|Relapsing-remitting Multiple Sclerosis|Secondary Progressive Multiple Sclerosis
Sponsor: Novartis
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 326
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-10-11
Completion Date: 2024-02-28
Locations: Novartis Pharmaceuticals, East Hanover, New Jersey, 07936, United States

Summary:
This was an observational retrospective cohort study using electronic medical records (EMRs) to study immunoglobulin levels over time among patients with relapsing forms of multiple sclerosis (MS) newly initiating anti-CD20 monoclonal antibody treatment in clinical practice.

The index date was defined as the date of anti-CD20 drug initiation during the study period. The baseline period was defined as 12 months prior to the index date.

Primary Outcome Measures: Percentage Change per Year in Immunoglobulin G (IgG) Levels in Patients Receiving Ocrelizumab, Up to 5 years
Secondary Outcome Measures: Percentage of Patients Newly Treated with Ocrelizumab With Low Immunoglobulin Values, Low immunoglobulin values were defined as greater than or equal to 1 immunoglobulin G (IgG) lab value of less than 500 milligrams per deciliter (mg/dL) or greater than or equal to 1 immunoglobulin M (IgM) lab value of less than 25 mg/dL., Up to 5 years|Percentage Change per Year in Immunoglobulin M (IgM) Levels in Patients Receiving Ocrelizumab, Up to 5 years|Percentage Change per Year in IgG Levels Associated With Risk Factors in Patients Treated With Ocrelizumab, Risk factors included: age and disease duration., Up to 5 years
Clinical Study to Evaluate the Possible Efficacy and Safety of Febuxostat in Patients With Ulcerative Colitis Treated With Mesalamine
NCT Number: NCT06525974
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: EARLY_PHASE1
Conditions: Ulcerative Colitis
Interventions: DRUG: Febuxostat|DRUG: Mesalamine
Sponsor: Tanta University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 46
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2026-12-30

Summary:
Evaluation the possible efficacy and safety of febuxostat in patients with ulcerative colitis treated with mesalamine.

Primary Outcome Measures: Assessment of disease activity using Partial Mayo Scoring Index (PMSI) assessment for Ulcerative Colitis Activity., It depends on three items: stool frequency, rectal bleeding (blood in stool) and Physician's Global Assessment. Each item has a score from 0 to 3 and total PMSI is the sum of scores for the three items., 3 months|Health-related quality of life (HRQOL) using the short inflammatory bowel disease questionnaire ., Short Inﬂammatory Bowel Disease Ques-tionnaire (SIBDQ) version became widely known and is currently used worldwide both in clinical practice and clinical research. SIBDQ comprises a total of 10 questions grouped into four diﬀerent dimensions: social, bowel, emotional, and systemic \[6, 7\]. Each question is scored by a 7-point Likert scale, ranging from 1 (a severe problem) to 7 (not a problem at all), giving an absolute SIBDQ score ranging from 10 (poor HRQoL) to 70 (opti-mal HRQoL). A SIBDQ score below 50 was considered as poor QoL.there are no validated cut-oﬀs for the dif-ferent dimensions' scores. Hence, higher scores indicate a better HRQoL concerning that speciﬁc domain.Although patient-reported outcomes are highly valu-able for better patient care, patient responses to HRQoL instruments can be impacted by underlying cultural trends, 3 months
iTear Single-center, Open-label, Single-arm Study
NCT Number: NCT06525961
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Dry Eye Disease|Dry Eye Syndromes|Dry Eye|Meibomian Gland Dysfunction
Interventions: DEVICE: iTEAR100 Neurostimulator
Sponsor: The University of Hong Kong
Collaborators: ARCTIC VISION HONG KONG BIOTECH LIMITED
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2026-01
Locations: Department of Ophthalmology, LKS Faculty of Medicine, The University of Hong Kong, Hong Kong, Hong Kong

Summary:
This study aims to evaluate the effectiveness and safety of a device, iTEAR100 Neurostimulator (the device), which is designed to help people with Dry Eye Disease (DED) who are not satisfied with using artificial tears. The study will last three months and take place at one location. Thirty participants will use the iTEAR100 Neurostimulator, which stimulates the outside of the nose to help with dry eye symptoms.

Participants will have three main visits: one at the start (Day 0), one after 30 days (Day 30), and one at the end of the study (Day 90). For the first 30 days, they will use the device twice a day for 30 seconds on each side of the nose. After that, they will use it as needed for the next 60 days.

Before starting the treatment, participants will undergo tests to measure their initial eye condition. The effectiveness of the device will be checked by comparing these baseline measurements to those taken on Day 30 and Day 90. Participants will also fill out a questionnaire about their eye symptoms on Day 14.

The main measure of success is how much the participants' symptoms improve on the Ocular Surface Disease Index (OSDI) from Day 0 to Day 30. Other measures include changes in tear production, tear quality, and eye health from Day 0 to Days 30 and 90. Participants' safety will be monitored by tracking any adverse events (side effects) throughout the study.

Primary Outcome Measures: OSDI Score, Change in OSDI at Day 30 from Baseline (Statistical testing using one-sided one-sample t-test), 30 Days from baseline
Secondary Outcome Measures: OSDI Score, 1. Change in OSDI from baseline to Day 14 and Day 90, Day 14 and Day 90 from baseline|Schirmer Test, 2. Change in Schirmer Test Score from baseline to Day 30 and Day 90, Day 30 and Day 90 from baseline|Lipid Layer Thickness (Pre), 3. Change in tear lipid layer thickness (pre-stimulation) from baseline to Day 30 and Day 90, Day 30 and Day 90 from baseline|Lipid Layer Thickness (Pre vs Post), 4. Change between pre-stimulation and post-stimulation of tear lipid layer thickness in each visit, Day 14, Day 30, Day 90|Corneal/Conjunctival Staining, 6. Change in Corneal/Conjunctival Staining from baseline to Day 30 and Day 90, Day 30 and Day 90 from baseline
Efficacy and Safety of rhTPO in Combination With Cyclosporine Versus Cyclosporine Alone in the Treatment of TD-NSAA
NCT Number: NCT06525948
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Aplastic Anemia|Transfusion-dependent Anemia
Interventions: DRUG: rhTPO|DRUG: Cyclosporin A
Sponsor: Peking Union Medical College Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 54
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-30
Completion Date: 2025-12-30
Locations: Peking Union Medical College Hospital, Beijing, Beijing, 100730, China

Summary:
Investigating the efficacy and safety of rhTPO in combination with cyclosporine versus cyclosporine alone for the treatment of TD-NSAA

Primary Outcome Measures: ORR, Overall Response Rate (ORR): meets the criteria for CR and PR., 3 months|CRR, Complete Response Rate (CRR)：ANC\>1.5×10\^9/L，Hb\>100g/L，PLT\>100×10\^9/L；, 3 months
Secondary Outcome Measures: ORR, Overall Response Rate (ORR): meets the criteria for CR and PR., 6 months|CRR, Complete Response Rate (CRR)：ANC\>1.5×10\^9/L，Hb\>100g/L，PLT\>100×10\^9/L；, 6 months|Time for platelet count to recover to ≥20 x 10^9/L with a 1-fold increase in absolute value, Time for platelet count to recover to ≥20 x 10\^9/L with a 1-fold increase in absolute, through study completion, an average of 1 year|Proportion of patients with adverse events, safety event, through study completion, an average of 1 year
A Study of CT-388 in Participants With Obesity or Overweight With at Least One Weight-Related Comorbidity
NCT Number: NCT06525935
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Obesity|Overweight
Interventions: DRUG: CT-388|DRUG: Placebo
Sponsor: Carmot Therapeutics, Inc.
Collaborators: Hoffmann-La Roche
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 450
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-29
Completion Date: 2026-02-21
Locations: Velocity Clinical Research - Cincinnati (New Horizons Clinical Research), Cincinnati, Ohio, 45242, United States|Apex Mobile Clinical Research, Bellaire, Texas, 77401, United States|Velocity Clinical Research - Dallas, Dallas, Texas, 75230, United States

Summary:
This is a multi-center, randomized, double-blind, placebo-controlled, parallel group dose-finding study to evaluate the efficacy and safety of CT-388 at low, middle, and high doses.

Primary Outcome Measures: Percent Change in Body Weight from Baseline to Week 48, 48 Weeks
Secondary Outcome Measures: Percentage of Participants with Body Weight Reduction ≥5%, ≥10%, ≥15%, ≥20%, and ≥25% from Baseline to Week 48, 48 Weeks|Absolute Change in Body Weight (kg) from Baseline to Week 48, 48 weeks|Percent Change in Body Weight from Baseline to Week 48 by Obesity Class, 48 weeks|Change from Baseline to Week 48 in body weight-related parameters (Body Mass Index, waist circumference, hip circumference, waist-to-hip ratio, and waist-to-height ratio), 48 weeks|Change from Baseline to Week 48 in markers of glucose metabolism, 48 weeks|Proportion of patients with normoglycemia, prediabetes, and diabetes at baseline and Week 48, 48 Weeks|Number of participants with at least one Treatment-Emergent Adverse Event (TEAE), Serious Adverse Event (SAE), Adverse Event of Special Interest (AESI), AE leading to study drug discontinuation, 53 Weeks|Treatment-Emergent Adverse Events (TEAEs) That Occurred in >10% of Enrolled Participants, 53 Weeks|Number of Participants with Documented Hypoglycemia, 53 Weeks|Change from Baseline in the Patient Health Questionnaire-9 (PHQ-9) Score, 53 Weeks|Number of participants with Columbia Suicide Severity Rating Scale (C-SSRS) Events from Baseline through 53 Weeks, 53 Weeks|Change from Baseline in safety laboratory values, vital signs, and electrocardiograms, 53 Weeks
Preventing Perinatal Depression
NCT Number: NCT06525922
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Perinatal Depression
Interventions: BEHAVIORAL: Center M
Sponsor: Oregon Health and Science University
Sex: FEMALE
Age: ADULT
Enrollment: 87
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2021-08-04
Completion Date: 2024-03-13
Locations: Oregon Health & Science University, Portland, Oregon, 97239, United States

Summary:
The goal of this pilot study is to evaluate the acceptability, feasibility, mechanisms of action, and efficacy of Center M. Center M is a group-based, mindfulness-based Cognitive Behavioral Therapy (CBT) intervention to treat Perinatal Depression (PD).

Primary Outcome Measures: Edinburgh Postnatal Depression Scale (EPDS), 10-item self-report measure used to assess perinatal depression symptomology over the past seven days., Measured at pre-intervention (within 1 week before first session), post-intervention (within 1 week after last session), and 6-weeks postpartum|Patient Health Questionnaire - 8 (PHQ-8), Self-report measure that assesses depressive symptoms over the past two weeks., Measured at pre-intervention (within 1 week before first session), post-intervention (within 1 week after last session), and 6-weeks postpartum|Five Facets of Mindfulness Questionnaire (FFMQ), 39-item self-report measure to assess mindfulness skills., Measured at pre-intervention (within 1 week before first session) and 6-weeks postpartum|Emotional Regulation Questionnaire (ERQ), 10-item self-report measure used to assess one's ability to regulate or manage emotion using cognitive reappraisal and expressive suppression., Measured at pre-intervention (within 1 week before first session) and 6-weeks postpartum
Secondary Outcome Measures: ERQ Cognitive Reappraisal Subscale, 6 items to reflect cognitive reframing or restructuring., Measured at pre-intervention (within 1 week before first session) and 6-weeks postpartum|ERQ Expressive Suppression Subscale, 4 items to reflect expressive suppression., Measured at pre-intervention (within 1 week before first session) and 6-weeks postpartum|Center M Satisfaction, 60 minute telehealth format focus groups including open-ended questions about their experience with Center M or two-question survey with a Likert scale satisfaction question and a free text question., Post-intervention (within 1 week after last session)
A Real-world Study of Staging and Grading of Clinical Immune Status in Chronic Hepatitis B
NCT Number: NCT06525909
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Hepatitis B, Chronic
Sponsor: Tongji Hospital
Sex: ALL
Age: ADULT
Enrollment: 250
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-01-20
Completion Date: 2028-12-10
Locations: Tongji Hospital, Wuhan, Hubei, China|Beijing YouAn Hospital, Beijing, China|The First Hospital of Jilin University, Changchun, China|Southwest Hospital, Chongqing, China|Jiangsu Province Hospital, Nanjing, China

Summary:
This is a prospective, multicentre observational study of Chronic Hepatitis B （CHB）in different clinical stages. We intend to compare the immune status of various types of CHB patients, and we propose to establish a staging and grading criteria for the immune exhaustion status of patients with CHB.

Primary Outcome Measures: A preliminary exploration of staging and grading criteria for the state of immune, The clinical characteristics, viral load and immune cells frequency (CD4+ or CD8+ T cells, etc) of CHB in different clinical stages will be studied., week 200
Analysis of Patients With Post-traumatic Vertebral Fracture and Accompanying Rib Fracture
NCT Number: NCT06525883
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Vertebral Fracture|Rib Fractures|Trauma
Interventions: OTHER: No intervation
Sponsor: Ege University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 151
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-01-01
Completion Date: 2024-02-01
Locations: Ege University Faculty of Medicine, İzmir, Bornova, 35100, Turkey

Summary:
The present study investigates the trauma mechanisms, the type and level of vertebral fractures, the number of accompanying rib fractures and thoracic pathologies, the surgical procedures employed and the development of complications in a sample of patients who presented with vertebral fractures and concurrent rib fractures after sustaining trauma.

Primary Outcome Measures: rib fracture, number of accompanying rib fractures, 12 months|complications, Number of patients developing complications, 12 months|surgical intervention, Number of patients requiring surgical intervention, 12 months