pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Volumetric Quantification of Epicardial Fat Using Semiautomated High Resolution Atrial CT Segmentation in Patients With Atrial Fibrillation Receiving Catheter Ablation
NCT Number: NCT06559787
Acronym: AFAT
Status: ACTIVE_NOT_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Atrial Fibrillation
Sponsor: Deutsches Herzzentrum Muenchen
Collaborators: The German Heart Foundation
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-08-18
Completion Date: 2025-06-30
Locations: Deutsches Herzzentrum, München, 80634, Germany

Summary:
The goal of this prospective observational study is to learn about the influence of epicardial fat on the success of catheter ablation in patients with atrial fibrillation.

Primary Outcome Measures: Influence of epicardial adipose tissue (EAT) volume on 1 year arrhythmia recurrences after catheter ablation, influence of EAT volume quantified by volumetric CT segmentation on 1 year arrhythmia recurrences after catheter ablation for paraxysmal or persistent atrial fibrillation, measurement of epicardial fat at baseline; anamnestic and ECG-control of arrhythmia after 3, 6 and 12 months
Secondary Outcome Measures: associations between EAT and gender, BMI, cholesterol levels, body fat, associations between EAT and gender, BMI, cholesterol levels, body fat, measurement of epicardial fat at baseline; anamnestic and ECG-control of arrhythmia after 3, 6 and 12 months|associations between EAT and left atrial wall thining, associations between EAT and left atrial wall thining, measurement of epicardial fat at baseline; anamnestic and ECG-control of arrhythmia after 3, 6 and 12 months|associations between EAT and low voltage areas quantified by high density electroanatomical mapping, associations between EAT and low voltage areas quantified by high density electroanatomical mapping, measurement of epicardial fat and catheter ablation at baseline
The Hastiin Bidziil (Strong Man) Intervention
NCT Number: NCT06559774
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Substance Use
Sponsor: Johns Hopkins Bloomberg School of Public Health
Sex: MALE
Age: ADULT
Enrollment: 160
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-10
Completion Date: 2028-10

Summary:
The Hastiin Bidziil (Strong man) Intervention study is part of a larger project called, Community-Driven Indigenous Research, Cultural Strengths \& Leadership to Advance Equity in Substance Use Outcomes (CIRCLE) Center of Excellence. CIRCLE aims to address drug use related health problems in collaboration with diverse Indigenous communities. This study is a randomized controlled trial study to measure the effectiveness of a secondary prevention program, called Hastiin Bidziil (Strong Man), aimed at reducing substance use among Native American Indian (AI) men ages 18-26.

Primary Outcome Measures: Number of days of substance sse as assessed by Time Line Follow-back, Number of days of substance use over the previous month measured at 6-months post baseline using Timeline Follow-Back (TLFB), 6-months post baseline
A Trial of Transcranial Magnetic Stimulation in the Treatment of Functional Dyspepsia
NCT Number: NCT06559748
Status: TEMPORARILY_NOT_AVAILABLE
Study Type: EXPANDED_ACCESS
Conditions: Functional Dysphonia
Interventions: DEVICE: transcranial magnetic thetaburst stimulation （TBS）
Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sex: ALL
Age: ADULT, OLDER_ADULT

Summary:
The goal of this clinical trial is to learn if theta burst stimulation (TBS), a form of Transcranial Magnetic Stimulation (TMS), can treat functional dyspepsia (FD) and compare its effectiveness against conventional drug treatments in patients diagnosed with FD. The main questions it aims to answer are:

Does TBS improve FD-related symptoms and associated mental health conditions such as anxiety and depression? How does the effectiveness of TBS compare to conventional drug treatments for FD?

Researchers will compare TBS treatment, sham TBS treatment, and conventional drug treatment to see if TBS is effective in treating FD. Participants will:

Undergo TBS or sham TBS treatment, or take conventional medications as prescribed.

Have their FD symptoms, anxiety, and depression levels assessed before and after the treatment.

Be evaluated at various intervals (Day 3, Month 1, Month 3, Month 6) for symptom improvement and side effects.

Participants are adults aged 18-70, diagnosed with FD, and willing to participate in this study. They will be randomly assigned to one of the three groups: TBS, sham TBS, or conventional drug treatment, with an equal number of participants in each group.

The study will be conducted over two years, from November 1, 2023, to October 31, 2025, at the Second Affiliated Hospital of Zhejiang University School of Medicine.
Local Cerebral Oxygenation in Chronic Pain Patients Utilizing Spinal Cord Stimulation
NCT Number: NCT06559735
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Chronic Pain
Interventions: DEVICE: CereVu Device
Sponsor: CereVu Medical, Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 25
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-08-13
Completion Date: 2025-03-31
Locations: Boomerang Healthcare, Walnut Creek, California, 94598, United States

Summary:
The primary objective of the study is to determine changes in cerebral nociceptive hemodynamic response (blood oxygenation/flow) before, during and following spinal cord stimulation (SCS). Objective measurements of cerebral nociceptive hemodynamic responses will be obtained with the CereVu sensor and ROPA system and will be analyzed offline and compared against subjective measures of pain. Proprietary analysis algorithms will be incorporated and developed to understand how the objective measurements correlate with subject reported pain levels

Primary Outcome Measures: Regional Cerebral Oxygenation/Blood Flow, Opital Spectophotometry measurement from the forehead, 1 week|Numerical Pain Rating Scale (NRS), Subjective pain 11-point pain scale, 1 week
Secondary Outcome Measures: Stress/Anxiety, Hamilton Anxiety Rating Scale, 1 week
A Trial Investigating the Efficacy and Safety of Insulin Degludec/Liraglutide Injection in Subjects With Type 2 Diabetes
NCT Number: NCT06559722
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Type 2 Diabetes
Interventions: DRUG: Insulin Degludec/liraglutide Injection|DRUG: XULTOPHY®
Sponsor: Tonghua Dongbao Pharmaceutical Co.,Ltd
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 510
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2026-02

Summary:
This is a randomised, open-label, multicenter, active-controlled, parallel-design, phase III clinical trial. The purpose of this study to compare the efficacy and safety of Insulin Degludec/Liraglutide Injection with XULTOPHY® once daily via subcutaneous injection in Chinese Subjects with Type 2 Diabetes.

Primary Outcome Measures: Change from baseline in HbA1c after 26 weeks of treatment, Calculated based on HbA1c level measured in plasma, Baseline, Week 26
Secondary Outcome Measures: Proportion of subjects that achieved HbA1c<7% after 12, 26 weeks of treatment, Calculated based on HbA1c level measured in plasma, Week 12, Week 26|Proportion of subjects that achieved HbA 1c ≤ 6.5% after 12, 26 weeks of treatment, Calculated based on HbA1c level measured in plasma, Week 12, Week 26|Changes from baseline in fasting plasma glucose (FPG) after 12, 26 weeks of treatment, Calculated based on FPG level measured in plasma, Baseline, Week 12, Week 26|Change from baseline in 7-point SMBG values after 12, 26 weeks of treatment, Calculated based on 7-point SMBG values, Baseline, Week 12, Week 26|Change from baseline in body weight after 12, 26 weeks of treatment, Calculated based on body weight measurement, Baseline, Week 12, Week 26|Number of treatment emergent adverse events, Count, From Baseline to Week 27|Number of treatment emergent hypoglycaemic episodes, Count, From Baseline to Week 27|Number of participants with injection site reactions, Count (spontaneous pain, tenderness, itching, redness, edema, induration/infiltration), From Baseline to Week 27|Incidence of anti-drug antibodies (ADA), and neutralising antibodies (if applicable), Calculated based on the values of anti-drug antibodies (ADA), and neutralising antibodies (if applicable), Baseline, Week 12, 26, and 27 (if applicable)|Plasma concentrations of degludec, liraglutide, Calculated based on plasma concentrations of degludec, liraglutide, Baseline, Week 2, 6, 12, 20, 26
A Plant-Based Whole-Foods Meal Delivery Service for Patients With Multiple Myeloma Undergoing Autologous Hematopoietic Cell Transplant
NCT Number: NCT06559709
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Multiple Myeloma
Interventions: PROCEDURE: Biospecimen Collection|OTHER: Dietary Intervention|OTHER: Dietary Intervention|OTHER: Medical Chart Review|OTHER: Questionnaire Administration
Sponsor: Fred Hutchinson Cancer Center
Collaborators: Swim Across America
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-12-01
Completion Date: 2025-06-25
Locations: Fred Hutch/University of Washington Cancer Consortium, Seattle, Washington, 98109, United States

Summary:
This clinical trial evaluates the impact of a plant-based whole-foods delivery service on the microbiome in patients with multiple myeloma undergoing an autologous hematopoietic cell transplant. An autologous hematopoietic cell transplant is a procedure in which blood-forming stem cells (cells from which all blood cells develop) are removed, stored, and later given back to the same person. Loss of microbial diversity within the intestinal tract has been associated with poor outcomes for patients receiving autologous stem cell transplantation. A plant-based whole meal delivery service may increase the intake of foods high in fiber and nutrients therefore improve microbial health during the peri-transplant period. In this pilot study, study investigators will explore the feasibility of this approach.

Primary Outcome Measures: Enrollment rate, The proportion of eligible patients who consent to enroll in the study will be computed based on the number approached and estimated with 95% confidence intervals. Reasons for non-participation will be summarized., Up to 1 year|Collection rate, Collection rate will be the percentage of stool samples, blood samples and surveys collected., Up to 1 month post transplant|Tolerability of the delivered diet: Patient opinion, Patient opinion of the delivered meals will be assessed using qualitative end-study surveys., Up to 1 month post transplant|Tolerability of the delivered diet: Proportion of meals consumed, Patient acceptability of the delivered meals will be assessed using proportions of the delivered meals consumed based on multi-day food diaries and 24-hour recall assessments., Up to 1 month post transplant
Internal Mammary Lymph Nodes Irradiation in High-risk Breast Cancer After Neoadjuvant Chemotherapy
NCT Number: NCT06559696
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Breast Cancer
Interventions: RADIATION: internal mammary nodal irradiation|RADIATION: No internal mammary node irradiation
Sponsor: Fujian Medical University Union Hospital
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 722
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-15
Completion Date: 2032-07-15
Locations: Fujian Medical University Union Hospital, Fuzhou, Fujian, 350001, China

Summary:
The aim of this study is to explore the impact of internal mammary nodal irradiation on disease-free survival in high-risk breast cancer patients (ypN+or supra/subclavicular lymph node positive) after neoadjuvant chemotherapy.

Primary Outcome Measures: Disease free survival, From date of enrollment until to the first recurrence in the ipsilateral breast or chestwall, the regional nodal area, or a distant site or death due to any cause, 5 years
Secondary Outcome Measures: Overall survival, From date of enrollment until the date of death from any cause., 5 years|Distant metastasis-free survival, The time of randomization to the first recurrence in a distant site., 5 years|Local-regional recurrence-free survival, The time of randomization to the first recurrence in the ipsilateral breast or chest wall and the regional nodal area., 5 years
Comparison of Sensory Analysis After Superficial and Deep Parasternal Intercostal Plane Blocks
NCT Number: NCT06559683
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Pain, Postoperative
Interventions: OTHER: Sensory Assessment
Sponsor: Ondokuz Mayıs University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 24
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-01
Completion Date: 2024-12-01

Summary:
Postoperative pain following cardiac surgery is a common issue that can negatively impact patients' quality of life. Effective perioperative pain management is crucial to improving patient outcomes. Pain is typically most intense during the first two postoperative days, and inadequate management can lead to chronic pain, further diminishing quality of life. Recent advances in ultrasound-guided regional anesthesia, including superficial and deep parasternal intercostal plane blocks, have enhanced acute pain control. These blocks aim to provide analgesia by targeting the anterior cutaneous branches of the T2-6 thoracic nerves. While their efficacy is recognized, sensory evaluation and dermatomal analysis remain unexplored. Cadaver studies suggest that the deep block may cover more parasternal space than the superficial block.

Primary Outcome Measures: Extent of Sensory Blockade Measured by Cold Sensation Testing Across the Anterior Chest Wall Following Deep and Superficial Parasternal Intercostal Plane Blocks., Participants will undergo sensory assessment using standardized cold sensation test at 30 minutes post-block to evaluate the maximum sensory blockade. The data will be recorded as the area of sensory loss (in cm) along the anterior chest wall, and the results will be aggregated to report the maximum area of sensory blockade achieved for both deep and superficial blocks. Cold sensation will be categorized as Normal Cold, Reduced Cold, or No Cold Sensation. A successful block is defined as a complete loss or reduction of cold sensitivity., 30 minutes after the blocks
Secondary Outcome Measures: Regression of Sensory Blockade at 12 and 24 Hours Post-Block, Block regression will be evaluated at 12 and 24 hours after block administration using cold sensation testing with ice tubes. The cold sensation will be categorized as Normal Cold, Reduced Cold, or No Cold Sensation. Participants who report Normal Cold sensation will be considered to have experienced block regression., Postoperative Day 1|Opioid Consumption, Opioid consumption at 12, and 24 hours after block administration will be measured by IV patient controlled analgesia., Postoperative Day 1|Acute pain scores, Pain status at rest and while coughing will be assessed by Numeric Rating Scale (NRS) scores at 12, and 24 hours after block administration.The NRS is an 11-point numeric scale which ranges from 0 to 10., Postoperative Day 1
Investigation of the Consistency Between Innovative Methods for Measuring the Area and Depth of Pressure Injuries
NCT Number: NCT06559657
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Pressure Injury|Innovativeness|Wound
Interventions: DEVICE: eKare Insight, imitoMeasure Mobile App, Visitrak
Sponsor: Ege University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 125
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2022-08-12
Completion Date: 2024-03-13
Locations: Ege University, İzmir, Bornova, 35100, Turkey

Summary:
Wound healing is a complex process and wound care and evaluation is one of the most important problems in current medicine. Wounds are seen in clinics as diabetic foot ulcers (DFU), arterial and venous ulcers, pressure injuries, surgical wounds and so on. Pressure injuries (PI) have a high mortality rate (29%) among elderly individuals. The prevalence of PIs in different countries worldwide varies between 6% and 18.5% in acute care settings. Wound assessment is an integral part of nursing practice.

Improper assessment of wounds may lead to inadequate wound care, resulting in delayed wound healing, increased risk of infection, increased costs, and decreased patient quality of life. Wound measurement is a useful quantitative finding in wound assessment, used as a practical approach to monitor wound healing. An ideal wound measurement method should be practical, comfortable for the patient, high accuracy, reliability and applicability. In clinical practice, it is essential to regularly reassess wounds to monitor changes in size, depth, and appearance over time.

With the emergence of new techniques and technologies, there is a need for methods that can be considered as the gold standard in the measurement of wound dimensions. It is seen in the literature that studies comparing two- and three-dimensional measurement methods are generally carried out on superficial wounds and very limited wound types. In addition, there are hardly any studies comparing depth measurements with three-dimensional methods. In this direction, it was necessary to conduct this study in order to create evidence-based data in the field. The research has the quality of being the first and original study in our country that evaluates the compatibility of innovative methods in the area measurement of PIs and measures the wound depth.

Primary Outcome Measures: Wound area measurment, It is the measurement of wound area with three different methods., Approximately 5 minutes until the wound is selected and the measurement is completed.|Wound depth measurment, It is the measurement of wound depth with two different methods., Approximately 5 minutes until the wound is selected and the measurement is completed.
Hema-NeoTIL01 Cell Infusion Therapy in Relapsed/Refractory Acute Leukemia
NCT Number: NCT06559644
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: EARLY_PHASE1
Conditions: Leukemia, Myeloid, Acute|B-cell Acute Lymphoblastic Leukemia
Interventions: BIOLOGICAL: Hema-NeoTIL01
Sponsor: The First Affiliated Hospital of Soochow University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2026-12-01
Locations: The First Affiliated Hospital of Soochow University, Suzhou, Jiangsu, 215006, China

Summary:
This clinical trial aims to investigate the safety, optimal dosage, and effectiveness of autologous tumor-specific T cells, known as Hema-NeoTIL0 in treating relapsed/refractory B-ALL/AML.

Primary Outcome Measures: CR/CRi, MRD-negative CR, Complete remission (CR) is defined as the presence of less than 5% bone marrow blasts in an aspirate containing spicules, accompanied by independence from transfusions.

CR with incomplete hematologic recovery (CRi) is defined as the presence of less than 5% bone marrow blasts, with either an absolute neutrophil count (ANC) of less than 1×10\^9/L or a platelet count of less than 100×10\^9/L, while remaining transfusion-independent but exhibiting persistent cytopenia.

Minimal residual disease (MRD)-negative CR is defined as a leukemic cell count below the sensitivity threshold of 1×10\^-4 (0.01%) of bone marrow mononuclear cells (MNCs), as measured by multiparameter flow cytometry., Within 28 days after the first dose
Secondary Outcome Measures: RFS, Relapse-free survival (RFS) is defined as the interval from the date of achieving CR to the first occurrence of leukemia relapse, death, or the date of the last follow-up., 2 years|OS, Overall survival (OS) is defined as the duration from the time of enrollment to death from any cause., 2 years|Adverse events, The number of adverse events are evaluated with CTCAE V5.0., Within 28 days after the first dose
Adaptation of Community Reinforcement Approach for the Treatment of Drug Addiction
NCT Number: NCT06559631
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Substance Use Disorders|Comorbidities and Coexisting Conditions
Interventions: BEHAVIORAL: Indigenously Adapted CRA
Sponsor: Muhammad Saghir
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 59
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2022-02-04
Completion Date: 2023-07-25
Locations: Hayat Rehab Clinic (HRC), Islamabad, 46500, Pakistan|Islamabad Rehab Clinic (IRC), Islamabad, 46500, Pakistan

Summary:
Central idea of the study is to adapt a treatment program for drug addiction treatment indigenously and relapse prevention, and to establish its efficacy.

This study helps the society to have an evidence-based approach with proven efficacy to deal with drugs related issues in Pakistan along with minimizing the rate of relapse which is the major issue with current disease model for treatment of addiction in different rehabs within the country.

Present study's aim is to adapt culturally and islamically a robust treatment protocol: Reinforcement Approach (CRA) through randomized control trial to determine its efficacy in the field of drug addiction rehabilitation. Moreover, CRA is also be used with comorbid psychological illnesses. Because, in the treatment facilities disease model is currently prevailing which lacks empirical evidence, and they do not have proven efficacy.

Primary Outcome Measures: Recovery, Staying in abstinence from the drug of abuse. Recovery will be measured through Addiction Recovery Questionnaire (ARQ), this is a 4 point rating scale which measures normal living, abstinence and positive expectancy as recovery's subscales., First assessment will be conducted at the time of admission which will be completed till 21 days after admission. Second assessment after 120 days at the time of discharge. Third outcome measure during the follow up at the sixth month after discharge.
Secondary Outcome Measures: Comorbidities, comorbidities associated with substance use disorders will also be included and measured through Symptoms checklist-90 (SCL-90), 5 point rating scale., First assessment will be conducted at the time of admission which will be completed till 21 days after admission. Second assessment after 120 days at the time of discharge. Third outcome measure during the follow up at the sixth month after discharge.
Bacteriophage Therapy in Spinal Cord Injury Patients With Bacteriuria
NCT Number: NCT06559618
Acronym: Phage
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Bacteriuria|Spinal Cord Injuries|Asymptomatic Bacteriuria|Escherichia Coli
Interventions: DRUG: Phage Therapy|OTHER: Placebo
Sponsor: Barbara Wells Trautner
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2026-12

Summary:
This is a Phase 1b study to assess the safety, tolerability, PK, and PD of investigational phage therapy (IP) in adults with SCI and bladder colonization (ASB). It is a single-center, randomized, double-blind, placebo-controlled study in adults with SCI with neurogenic bladders and bacteriuria who use indwelling catheters, or who require intermittent catheterization for bladder drainage.

Primary Outcome Measures: To evaluate the safety and tolerability of phage therapy in adults ≥18 years of age with spinal cord injury (SCI) and bacteriuria with Escherichia coli (E. coli), Safety and tolerability analysis of Adverse Events. The urinary symptom questionnaires provided by MedStar Health, USQNB will be used as a daily study diary.

Participant's charts for AEs while they are hospitalized, and during study visits on days 14, 21, and 35 if they have been discharged before Day 14.

Blood samples will be collected for chemistry and hematology on days 1, 3, 7, 14, 21, and 35.

Urine samples will be collected to detect and analyze markers of inflammation on Days 1, 2, 3, 5, 7, 14, 21, and 35., 2 years
Secondary Outcome Measures: To evaluate the pharmacokinetics (PK) of investigational phage therapy, Blood samples will be collected to quantify phage titers, which will be measured as PFU (plaque-forming units) per mL (milliliter) of blood.

To quantify phage titers, we will perform PCR to measure copies/volume of phage titer compared to a standard control of purified phage., 2 years|To evaluate of the pharmacodynamics (PD) of investigational phage therapy, Urine samples will be collected to analyze 1 log reduction in the urinary E. coli on Days 1, 2, 3, 5, 7, 14, 21, and 35.

Analysis of recurrence of urinary E. coli colonization, incidence of urinary tract infection based on clinical signs and symptoms.

Microbiological cure, defined as \<10\^3 CFU/mL of E. coli in the urine on Day 7., 2 years
Other Outcome Measures: To explore the influence of phage therapy on the urinary tract microbiota, Urine samples will be collected to analyze microbiome diversity, comparing pre-treatment sample to end of study sample.

Emergence of phage resistance among the targeted E. coli in the bladder., 2 years|To explore the influence of phage therapy on the digestive tract microbiota, Analysis of stool sample microbiome diversity, comparing pre-treatment to end of study., 2 years
Evaluation of Bone Gain Using Customized 3D Zirconia Barrier Versus Titanium Mesh
NCT Number: NCT06559605
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Bone Loss, Alveolar
Interventions: PROCEDURE: zirconia barrier|PROCEDURE: titanium mesh
Sponsor: Cairo University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 26
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-05-22
Completion Date: 2026-11-22
Locations: Cairo university, Cairo, Egypt

Summary:
Evaluation of clinical and radiographical amount of bone gained using customized 3D printed zirconia barrier compared to titanium mesh in combined ridge defect at the esthetic zone.

Primary Outcome Measures: horizontal bone gain, Horizontal bone gain will be assessed on CBCT after 6 months of bone augmentation, 6 months
Secondary Outcome Measures: Vertical bone gain, measured on CBCT in a linear dimension as a different in measurement between pre and post operative CBCT., 6 months after barrier placement|Quality of bone, The core biopsies will be sectioned and stained with H\&E stain for examination under a light microscope. Bone volume will be measured for each specimen and the mean volume for native bone and newly formed bone will be calculated for statistics, 6 months after barrier placement|Incidence of membrane exposure, Healing complications including membrane exposure during the period of barrier placement will be recorded and it's evaluated by visual inspection, up to 4 weeks|Membrane exposure area/percentage, The exposed area will be measured will be assessed by UNC-15 periodontal probe., up to 4 weeks|Soft tissue thickness, An endodontic spreader with a rubber stopper will be positioned on the soft tissue to record the thickness of the soft tissue., 6 months after barrier placement|Procedural time, Procedural time will be calculated with a stopwatch to measure the time of each procedure and detect differences in the time spend placing and removing the different membranes., during the surgery|Patient pain, Readings will be recorded by the patient for the first 12 days after the surgery using the visual analogue scale (VAS) which is a descriptive numerical rating scale of 0 to 10.

0 = No pain 1-3= Mild pain 4-6 = Moderate pain (bearable) 7-10 = Severe pain (unbearable), first 12 days after the surgery|Patient satisfaction, Patient will answer questionnaire related to postsurgical and outcome satisfaction (numerical), 6 months
Internal Unicompartmental Arthroplasty After Tibial Valgization Osteotomy
NCT Number: NCT06559592
Acronym: ArOs
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Knee Arthritis
Sponsor: University Hospital, Brest
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 38
Study Design: Observational Model: |Time Perspective: p
Start Date: 2021-08-05
Completion Date: 2021-11-02
Locations: CHU de Brest, Brest, 29609, France

Summary:
This retrospective, monocentric study is about outcomes concerning patients who benefit from medial unicompartmental knee arthroplasty after previous high tibial osteotomy. This previous high tibial osteotomy was performed because of genu varum.

Clinical, funtionnal and radiological outcomes were examined.

Primary Outcome Measures: Give the functional results using the Oxford score, for patients who underwent this procedure., Oxford Knee Scale (OKS) score results after a mean follow-up of 79 months after unicompartmental internal arthroplasty, and a mean follow-up of 185 months after tibial valgization osteotomy, from 4 to 185 months
Monoclonal Gammopathy With Clinical Significance in Patients With and Without Haematological Malignancies in Finistère Between 2012 and 2017 (GammaClinik)
NCT Number: NCT06559579
Acronym: GammaClinik
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Gammopathy, Monoclonal
Sponsor: University Hospital, Brest
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Observational Model: |Time Perspective: p
Start Date: 2021-10-01
Completion Date: 2023-10-30
Locations: CHU de Brest, Brest, 29609, France|CHIC de Quimper, Quimper, France

Summary:
Clinical symptoms associated with monoclonal gammapathy have been primarily studied in hematological malignancy and rarely in MGUS and hemopathy. Indeed, most studies focus on a specific type of clinical involvement that does not allow to understand the epidemiological distribution of clinical symptoms in this population. In addition, in most cases, studies of clinical impairment of monoclonal gammapathies focus on one symptom. This study could highlight disparities in the representation of clinical disorders associated with monoclonal gammapathies, depending on whether they are or not associated with a malignant hematology, and would provide a better overall picture of the distribution of these diseases. This study could potentially define prognosis values for certain clinical conditions that we would not find in the group of hematological malignancies. This study would also make it possible to investigate whether there are clinical disorders of monoclonal gammapathies associated with chronic lymphoma/lymphocytic leukemia. This would potentially guide future pathophysiological research. This bicentric study could, depending on the results, be supplemented later by a larger study.

Primary Outcome Measures: Search for a difference in the distribution of the various clinical conditions associated with monoclonal peaks in gammapathies of undetermined significance compared with hematological malignancies., The presence of a difference in the distribution of gammopathy-related clinical disorders between GMSI and hemopathies, 5 years
Evaluation of Postoperative Intracranial Pressure in Patients Undergoing Intracranial Tumor Surgery
NCT Number: NCT06559566
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: INTRACRANIAL TUMOR|INTRACRANIAL PRESSURE|OPTIC NERVE
Interventions: PROCEDURE: USG|PROCEDURE: BCT
Sponsor: Sezen Kumaş Solak
Collaborators: Bagcilar Training and Research Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-09-15
Completion Date: 2025-05-01

Summary:
Ultrasonography(USG)-guided optic nerve sheath diameter measurement and its correlation with brain computed tomography in the evaluation of intracranial pressure in patients who underwent intracranial brain tumor surgery.

Primary Outcome Measures: intracranial pressure, To compare the optic nerve diameter measurement ,USG and BBT values used to measure intracranial pressure in patients with brain tumor surgery, T0: Before anesthesia induction T1: peroperative5. minutes T2: At the end of the surgery 6.hours T3:after extubation 1 hours T4: postoperative 12.hours T5. postoperative 24.hours
Secondary Outcome Measures: Heart Rate, To compare the heart rate measurement, T0: Before anesthesia induction T1: preoperative 5.minutes T2: At the end of the surgery 6.hoursT3:after extubation 1 hours T4: postoperative 12.hours T5. postoperative 24.hours|Blood pressure, To compare the blood pressure measurement, T0: Before anesthesia induction T1: preoperative 5.minutes T2: At the end of the surgery 6.hours T3 extubation 1 hours T4: postoperative 12.hours T5. postoperative 24.hours
"Selinexor+Pegaspargase+Dexamethasone"in Ⅰ/Ⅱ NKTCL
NCT Number: NCT06559553
Acronym: Selinexor
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: NKTCL|Selinexor
Interventions: DRUG: Selinexor+pegaspargase+dexamethasone
Sponsor: Mingzhi Zhang
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2022-09-01
Completion Date: 2026-12-31
Locations: Oncology Department of The First Affilliated Hospital of Zhengzhou University, Zhengzhou, Henan, 450052, China

Summary:
evaluate the efficacy and safety of "Selinexor+pegaspargase+dexamethasone" in early stage NK/ T-cell lymphoma

Primary Outcome Measures: CRR, The proportion of patients whose tumor volume has reduced to a predetermined value and can maintain the minimum time limit is the sum of complete mitigation., From date of randomization until the date tumor volume has reduced, assessed up to 36 months
Ultra-Hypofractionated vs. Hypofractionated Radiation for Node-Positive Breast Cancer
NCT Number: NCT06559540
Acronym: SWIFT RT
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Node-positive Breast Cancer
Interventions: RADIATION: Hypofractionated radiation|RADIATION: Ultra-hypofractionated breast/chest wall and regional nodal radiation
Sponsor: Washington University School of Medicine
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 220
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-27
Completion Date: 2034-04-30
Locations: Washington University School of Medicine, Saint Louis, Missouri, 63110, United States

Summary:
In breast cancer patients with nodal involvement, numerous studies have demonstrated that adjuvant radiation therapy reduces the risk of local recurrence, regional recurrence, and distant metastases, in addition to improving survival. The dose and fractionation for adjuvant breast radiation therapy has evolved over time, as novel schedules have been compared to the current standard of care. Hypofractionated radiation therapy (266 cGy per fraction x 15-16 fractions over 3 weeks) has been shown to result in equivalent oncologic outcomes, as well as equivalent acute and late toxicity, when compared to standard fractionation (200 cGy per fraction x 25 fractions over 5 weeks). Subsequently, hypofractionated breast radiation has become the current standard of care.

More recently, ultra-hypofractionated breast radiation (520 cGy per fraction x 5 fractions over 1 week) was shown in a randomized trial to be non-inferior to hypofractionated radiation when treating the breast after lumpectomy. However, the efficacy and toxicity of using ultra-hypofractionated radiation therapy when also treating the regional nodes has not been reported. This is important, as there is greater radiation exposure to several normal tissues, such as the arm/shoulder, brachial plexus, normal lymphatics, heart, and lung, when treating the regional nodes.

In this randomized study, the investigators aim to compare the tolerability and efficacy of ultra-hypofractionated breast/chest wall and regional nodal radiation (SWIFT RT) against hypofractionated radiation (RT). The investigators will evaluate acute and late toxicity, oncologic outcomes (including local recurrence, regional recurrence, distant metastasis, and overall survival), cosmesis, and patient-reported quality of life. The investigators will collect blood samples for correlative studies of biomarkers of fibrosis and cardiac toxicity.

Primary Outcome Measures: Proportion of patients who are free of serious treatment related late toxicity., Toxicities of concern may include lymphedema, radiation pneumonitis, brachial plexopathy, rib fracture, cardiac disease, and breast/chest wall fibrosis., Day 91 through 5 year follow-up (estimated to be 5 years and 1 month)
A Research Study Looking Into Blood Levels of the Medicine NNC0487-0111 in the Body and How Well it is Tolerated in Participants With Reduced Kidney Function and Normal Kidney Function
NCT Number: NCT06559527
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Diabetes Mellitus, Type 2|Obesity|Overweight
Interventions: DRUG: NNC0487-0111
Sponsor: Novo Nordisk A/S
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 42
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-20
Completion Date: 2025-02-27
Locations: Charité Research Organisation GmbH, Berlin, 10117, Germany

Summary:
Novo Nordisk is developing the study medicine NNC0487-0111 to treat people living with type 2 diabetes and/or people living with overweight or obesity. The aim of this study is to see if blood levels of NNC0487-0111 are the same in people living with various degrees of reduced kidney function as for people with normal kidney function. Participants will be given one single injection by the study staff in a skinfold in their stomach using a pen device (NovoPen®4).

Primary Outcome Measures: AUC0111,0-∞,SD: Area under the NNC0487-0111 plasma concentration-time curve from time 0 to infinity after a single dose, Measured as hours\*nanomole per liter (h\*nmol/L)., From baseline (Visit 2, Day 1, pre-dose) until completion of the end of study visit (Visit 9, Day 28)
Secondary Outcome Measures: Cmax,0111,SD: Maximum observed plasma NNC0487-0111concentration after a single dose, Measured as nanomole per liter (nmol/L)., From baseline (Visit 2, Day 1, pre-dose) until completion of the end of study visit (Visit 9, Day 28)|tmax,0111,SD: Time to maximum observed plasma NNC0487-0111 concentration after a single dose, Measured as hours., From baseline (Visit 2, Day 1, pre-dose) until completion of the end of study visit (Visit 9, Day 28)|t½,0111,SD: Terminal half-life of NNC0487-0111 after a single dose, Measured as hours., From baseline (Visit 2, Day 1, pre-dose) until completion of the end of study visit (Visit 9, Day 28)|Vz/F0111,SD: Apparent volume of distribution of NNC0487-0111 after a single dose, Measured as liter (L), From baseline (Visit 2, Day 1, pre-dose) until completion of the end of study visit (Visit 9, Day 28)|CL/F0111,SD: Apparent clearance of NNC0487-0111 after a single dose, Measured as liter per hour (L/h)., From baseline (Visit 2, Day 1, pre-dose) until completion of the end of study visit (Visit 9, Day 28)|Number of treatment emergent adverse events (TEAEs), Measured as number of events., From time of trial product administration (Visit 2, Day 1) until completion of the end of study visit (Visit 9, Day 28)
IVB for Post-vitrectomy Hemorrhage in Diabetic Eyes
NCT Number: NCT06559488
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Diabetic Retinopathy|Vitreous Hemorrhage
Interventions: DRUG: Bevacizumab Injection [Avastin]|PROCEDURE: Pars Plana Vitrectomy
Sponsor: Universitas Padjadjaran
Collaborators: Cicendo Eye Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 18
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2018-04-02
Completion Date: 2019-03-31
Locations: Cicendo Eye Hospital, Bandung, Jawab Barat, 40117, Indonesia

Summary:
Recurrent vitreous hemorrhage following pars plana vitrectomy (PPV) for proliferative diabetic retinopathy remains a significant complication with reported incidence ranging from 11 to 75%. Early and late recurrences are associated with various factors, including residual blood, fibrovascular tissue, and neovascularization. Despite attempts to reduce this complication with therapies like anti-fibrinolytic agents, gas tamponade, and peripheral cryotherapy, the outcomes remain unsatisfactory.

Primary Outcome Measures: Incidence and Severity of Vitreal Hemorrhage Post-Operative, Calculation of incidence of Vitreal Hemorrhage Post Operative based on grading (Grade 0, Grade 1, Grade 2, Grade 3, Grade 4) between two groups; higher grades are related to worse outcomes, Day 1, 7, and 30
Secondary Outcome Measures: Post operative visual Acuity, compared between groups, Visual acuity measured with a Snellen chart was converted to logarithm of the minimum angle of resolution (logMAR) for statistical analysis. Snellen visual acuity of finger counting was categorized as log MAR 2.0, and hand motion as log MAR 3.0, Day 1, 7, and 30
A Multicenter, Randomized Controlled Study to Evaluate the Safety and Efficacy of the Super-Bore 8F Thrombosis Aspiration Catheter in the Treatment of Acute Intracranial Large Vessel Occlusion
NCT Number: NCT06559475
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Acute Ischemic Stroke|Endovascular Thrombectomy
Interventions: PROCEDURE: Super-Bore 8F Thrombosis Aspiration Catheter treatment group|PROCEDURE: Conventional thrombectomy device treatment group
Sponsor: The First Affiliated Hospital of University of Science and Technology of China
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 360
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2025-12-01
Locations: The First Affiliated Hospital of University of Science and Technology of China, Hefei, Anhui, China

Summary:
To Evaluate the Safety and Efficacy of the Super-Bore 8F Thrombosis Aspiration Catheter in the Treatment of Acute Intracranial Large Vessel Occlusion.

Primary Outcome Measures: The Rates of First Pass Effect (eTICI2c-3), Evaluate effect of thrombectomy on reperfusion, Within 5 minutes at final angiography of thrombectomy
Secondary Outcome Measures: Proportion of mRS 0-2 at 90 days, Modified Rankin scale (range, 0 to 6, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death), 90 (± 14 days) after procedure|Proportion of mRS 0-1 at 90 days;, Modified Rankin scale (range, 0 to 6, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death), 90 (± 14 days) after procedure
Other Outcome Measures: Symptomatic intracerebral hemorrhage (sICH), sICH means any hemorrhage with neurological deterioration, as indicated by an NIHSS score that was higher by ≥4 points than the value at baseline or the lowest value in the first 24 hours , or any hemorrhage leading to death., 24 hours after procedure
Nudge Strategies for DPYD Testing in Patients With Gastrointestinal Cancers Treated With Fluoropyrimidines
NCT Number: NCT06559462
Acronym: DPYD Nudges
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: DPYD Gene Mutation|Gastrointestinal Cancer|Health Care Seeking Behavior
Interventions: OTHER: Focus Group|OTHER: Discrete Choice
Sponsor: Abramson Cancer Center at Penn Medicine
Collaborators: National Cancer Institute (NCI)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 160
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2024-08
Completion Date: 2025-08
Locations: Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, 19104, United States

Summary:
5-fluorouracil and capecitabine, sometimes called 5-FU, fluoropyrimidines, or Xeloda are a type of chemotherapy. Many people have side effects from these drugs like nausea, diarrhea, or blood problems. This research study is being conducted to learn how to help increase the number of patients offered DPYD testing before taking this type of chemotherapy drugs. DPYD testing can help predict risk of side effects.

Different people's bodies break down and use drugs faster or slower. Genes are the instructions that tell our bodies how to do this. The DPYD gene is one of the genes that tell your body how to use chemotherapy drugs. Some people have changes in their DPYD gene that can make their side effects from chemotherapy worse, sometimes so bad that they die. DPYD testing can tell doctors which people have these gene changes and need extra monitoring during chemotherapy.

Some of the people in this study will join a focus group and read sample messages for future patients. They will discuss with the other participants how well the message does its job and anything that might make the message better. When there are no more messages, the host may ask about other information for future patients like a website or brochure.

Other people in the study will read sample messages that may be sent to future patients about DPYD testing. They will select the message that they like the best and might make them ask their oncologist about testing options.

Primary Outcome Measures: Developmental Nudge Feedback, Verbal data collected and coded, 90 minutes|Discrete Nudge Feedback, Binary choices, 45 minutes
Cholecystectomy During Weekends
NCT Number: NCT06559449
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Acute Cholecystitis
Sponsor: Umeå University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 15730
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-08-01
Completion Date: 2024-08-01
Locations: University Hospital of Umeå, Umeå, 90737, Sweden

Summary:
Acute cholecystitis is the most common acute complication of gallstone disease. Although there are diverging opinions about optimal timing for surgery, the general recommendation is that surgery is performed as soon as possible after admission when the diagnosis is established. The study will compare acute cholecystectomies for acute cholecystitis performed during weekends with procedures where patient have been waiting during weekend and surgery performed during a subsequent weekday.

Hypothesis: Performing acute cholecystectomies for acute cholecystitis during weekends are associated with higher risk for complications.

Primary Outcome Measures: Complication rate, Number of patients with registered complications after surgery, 30 days
Secondary Outcome Measures: Open surgery, Number of surgical procedures completed with open technique (open or laparoscopic converted to open), 30 days|Prolonged surgery, Number of surgical procedures with operating time more than 2 hours, 30 days