pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Comparison of Early Proton Pump Inhibitor Initiation Versus Usual Care on Acute Kidney Injury in Hemorrhagic Shock Patients
NCT Number: NCT06531642
Acronym: Trauma AKI PPI
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2|PHASE3
Conditions: Acute Kidney Injury
Interventions: DRUG: Protonix (Pantoprazole) 40 mg q 12 hrs for 2 days|DRUG: Protonix (pantoprazole) 40 mg q 24 hrs for 2 days
Sponsor: The University of Texas Health Science Center, Houston
Collaborators: The University of Texas Health Science Center at San Antonio
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-08-01
Completion Date: 2025-07-31
Locations: Memorial Hermann Texas Medical Center, Houston, Texas, 77030, United States

Summary:
The investigators propose a single-center, randomized, controlled trial to determine whether early initiation of proton pump inhibitor (PPI), pantoprazole, will decrease acute kidney injury (AKI) for trauma patients presenting with hemorrhagic shock compared to routine timing of initiation of PPI. Kidney injury will be assessed by the urinary kidney injury biomarkers, and the incidence, severity and AKI-free days within first week and major adverse kidney events (MAKE) at day 30. The specific aims of the study will be achieved by a cohort of 100 patients to receive either early(study) or routine (control) administration of pantoprazole for 2 days after the initial injury insult.

Primary Outcome Measures: Urinary Kidney Biomarker Levels, The investigators will measure the urinary kidney biomarker KIM-1 (kidney injury molecule-1) levels at the different time points of urine sample collection (baseline, 8 hrs, 24 hrs and 48 hrs), From enrollment until 48 hours after injury
Secondary Outcome Measures: Acute Kidney Injury Staging, The investigators will classify each patient to an AKI stage (1, 2 or 3) according to the 2012 Kidney Disease Improving Global Outcomes (KDIGO) which uses creatinine levels and estimated glomerular filtration rate (eGFR) levels each day for 5 days after enrollment., From enrollment until 5 days of initial injury|Major Adverse Kidney Events, The investigators will follow up on patients enrolled in the study and ask about patient demise, necessity of dialysis of any type, hospitalizations due to renal problems, or sustained kidney dysfunction after 30 days of enrollment., From enrollment until 30 days of initial injury
Risk-based Screen and Prognostic Analysis for Second Primary Malignancies in Kidney Cancer Patients
NCT Number: NCT06531629
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Kidney Cancer
Interventions: PROCEDURE: Surgery, radiation therapy and chemotherapy
Sponsor: Peking University First Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 72408
Study Design: Observational Model: |Time Perspective: p
Start Date: 2000-01-01
Completion Date: 2020-12-31
Locations: Peking University First Hospital, Beijing, Beijing, 100034, China

Summary:
Second primary malignancy (SPM) significantly impacts the survival and prognosis of patients. This study endeavors to identify risk and prognostic factors associated with SPM after first primary kidney cancer and construct predictive nomograms.

Primary Outcome Measures: Developing a second primary malignancy (SPM), This time was calculated as the time interval from the diagnosis of first primary kidney cancer to the diagnosis of second primary malignancy., This time was calculated as the time interval from the diagnosis of first primary kidney cancer to the diagnosis of second primary malignancy, assessed up to 20 years.|Overall survival (OS), OS was calculated as the time interval from the diagnosis of the second primary malignancy to death or the time to the last follow-up., From the date of diagnosis of the second primary malignancy to the date of death from any cause or the data of last follow-up, whichever came first, assessed up to 20 years.
Secondary Outcome Measures: Cancer-specific survival (CSS), CSS was calculated as the time interval from the diagnosis of the second primary malignancy to death from the same disease or the last follow-up., From date of diagnosis of the second primary malignancy until the date of death from the same disease or the date of last follow-up, whichever came first, assessed up to 20 years.
Healthcare Professionals' Attitude Towards Clinical Research in the United Arab Emirates
NCT Number: NCT06531616
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Behavior, Consumer|Research, Communication|Knowledge, Attitudes, Practice
Sponsor: Abu Dhabi Health Services Company
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 600
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-05-15
Completion Date: 2024-12-30
Locations: SEHA Head Quaters-Reserach Department, Abu Dhabi, United Arab Emirates

Summary:
Abu Dhabi Health Services Company (SEHA) is already in the process of providing support for research infrastructure, such as trained staff, medical facilities, funding, and training needs for its healthcare professionals (HCPs). An HCP's own interest in clinical research is an individualistic trait that SEHA wants to target and develop, complementary to its medical staff specialty, educational background, and willingness to learn.

The investigators' aim with this study is to understand the participants' perspective on challenges and barriers stopping them from conducting research and what supportive measures they have around them from the organization and the United Arab Emirates (UAE) that back their growth as research professionals at SEHA.

Primary Outcome Measures: Understanding Knowledge and Attitudes of SEHA Healthcare professionals toward clinical research., A self-built survey was created to cover the different aspects of the United Arab Emirates (UAE) healthcare organizational practices and clinical research practices. The survey was pilot-tested on 6 volunteers not related to the Abu Dhabi Health Services Company (SEHA) for comprehension and ease of reading. The survey aims to understand participants' perspectives on challenges and barriers stopping them from conducting research and what supportive measures they have around them from the SEHA as an organization and the UAE that back their growth as medical research professionals. The data collected can help guide in bringing positive organizational changes to enhance clinical research at SEHA and in the UAE., 3 months
Postoperative Analgesic Effectiveness of Bupivacaine With and Without Dexmedetomidine in Patients With Abdominal Surgery
NCT Number: NCT06531603
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: PHASE2|PHASE3
Conditions: Post Operative Pain|Bradycardia|Hypotension|Nausea|Vomiting
Interventions: DRUG: bupivacaine wound infilteration|DRUG: Bupivacaine plus dexmedetomidine wound infilteration
Sponsor: Sahiwal medical college sahiwal
Sex: ALL
Age: ADULT
Enrollment: 64
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2022-02-20
Completion Date: 2023-04-20
Locations: Sahiwal Medical College, Sahiwal, Punjab, 57000, Pakistan

Summary:
Abdominal surgeries are major surgical procedures that are performed at any teaching hospital. Pain control is major concern in the intra-operative as well as post-operative period in these patients. Optimal pain control in post-operative period is directly related to patient's recovery, shortens the patients' hospital stay and overall burden on health facilities. Inadequate pain control may affect quality of life and increases patient's morbidity and mortality. Different modalities for pain control are used in post-operative period. Opioids are mainstay of treatment in post-operative period but historically are associated with significant side effect profile like dependence, nausea, vomiting, respiratory depression, constipation and many others. Dexmedetomidine is centrally acting α-2 adrenoceptor agonist.

Primary Outcome Measures: Duration of analgesia, Time from procedure to requirement of rescue analgesia, Every 30 mints for 4hrs than 2hrly for 24 hrs post procedure
Secondary Outcome Measures: Opioid sparing, Total amount of opioid consumtion in the first 24 post procedure., Total dose of nalbuhine consumption in 1st 24 hrs after procedure|Blood pressure, Mean pressue will be measured, Every 15 minutes intra operative and every 15 minutes for 24 hrs postoperatively|Hear rate, Heart rate will be measured, Every 15 minutes intraoperative and every 15 minutes postoperatively for 24 hrs|Neausea, Felling of nasueas, Every 30 minutes for 4 hrs then 2hrly for 24 hrs|Vomiting, Urge to vomit, Every 3 minutes for first 4 hrs then 2hrly for 24 hrs
Anterior Shoulder Dislocation at Emergency Department
NCT Number: NCT06531590
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Shoulder Dislocation|Analgesia|Pain, Shoulder
Sponsor: Saglik Bilimleri Universitesi
Collaborators: Ankara Etlik City Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 140
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-03-01
Completion Date: 2026-03-01
Locations: Etlik City Hospital, Ankara, Yenimahalle, 06110, Turkey

Summary:
In this study, investigator will analyze the demographic characteristics of patients presenting to emergency department with Anterior Shoulder Dislocation. Investigators will document the mechanism of injury, orthopedic classification of shoulder dislocation, associated treatments, pre-procedural pain scoring, post-procedural pain scoring, as well as the duration of emergency department stay related to the preferred treatment, orthopedic consultation, and patient outcomes (discharge, admission to ward or intensive care unit, mortality). Aim of the study to investigate whether the current treatments used provide any superiority in emergency department outcomes for patients

Primary Outcome Measures: shoulder reduction, succesful reduction of shoulder joint and assessment of pain before and after analgesic treatments with pain scales ( visual analogue scale, verbal pain intensity scale, PAINAD ( pain assessment in advanced dementia) scale andvisual analogue scale), 24 hours
Atmospheric Pressure and Epistaxis Relationship
NCT Number: NCT06531577
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Atmospheric Pressure; Adverse Effect|Epistaxis Nosebleed
Sponsor: Saglik Bilimleri Universitesi
Collaborators: Ankara Etlik City Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 600
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-04-01
Completion Date: 2025-04-01
Locations: Etlik City Hospital, Ankara, Yenimahalle, 06170, Turkey

Summary:
In this study, investigators aim to understand the relationship between changes in atmospheric pressure and blood pressure, and to investigate whether these changes have an impact on the etiology of epistaxis.

Primary Outcome Measures: epistaxis, number of the patients with epistaxis will be evaluated accoridng to atmospheric preesure and wheather conditions on daily basis, 24 hours
Emergency Department Management of Femur Fractures
NCT Number: NCT06531564
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Femur Fracture|Pain, Joint|Analgesia
Sponsor: Saglik Bilimleri Universitesi
Collaborators: Ankara Etlik City Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 155
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-08-01
Completion Date: 2024-02-01
Locations: Etlik City Hospital, Ankara, Yenimahalle, 06110, Turkey

Summary:
Comparison of emergency department management of patients presenting with isolated hip fracture: comparison of methods used in pain management, monitoring, and treatment; comparison of hospitalization durations; comparison of mortality

Primary Outcome Measures: effective analgesia after receiving treatment, patients will be evaluated before and after analgesic treatments according to pain scales ( visual analogue scale, verbal pain intensity scale, PAINAD ( pain assessment in advanced dementia) scale andvisual analogue scale), effective pain management will be primary outcome, 24 hours
Effect of Low Molecular Heparin on Pregnancy Outcome With Protein S Deficiency
NCT Number: NCT06531525
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Pregnancy Related|Protein S Deficiency
Interventions: DRUG: Enoxaparin|DRUG: Aspirin|DRUG: Enoxaparin
Sponsor: Peking University People's Hospital
Collaborators: Beijing Obstetrics and Gynecology Hospital|Beijing Hospital|Peking Union Medical College Hospital|China-Japan Friendship Hospital|Sichuan Academy of Medical Sciences|Xiangya Hospital of Central South University|Chinese PLA General Hospital|Beijing Friendship Hospital|Beijing Chuiyangliu Hospital
Sex: FEMALE
Age: ADULT
Enrollment: 48
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-08-01
Completion Date: 2027-12-31
Locations: Peking University Insititute of Hematology, Peking University People's Hospital, Beijing, Beijing/Beijing, 100010, China

Summary:
To evaluate whether low molecular heparin could improve pregnancy outcomes in pregnancies with protein S deficiency.

Primary Outcome Measures: Rate of livebirth, Incidents of livebirth, From date of randomization until delivery, assessed up to 42 months
Secondary Outcome Measures: Parameters of maternal coagulation-related indicators, D-Dimer in ng/ml, Protein S activity in %, From the start of study treatment to 6 weeks post-partum|Parameters to assess the safety of low molecular heparin, Maternal platelet count in 10\^9/L, Number of haemorrhagic events, Number of cases of skin reactions at injection site, From the start of study treatment to 6 weeks post-partum|Other incidents of adverse pregnancy outcomes, early miscarriage (until 12 weeks of gestation), late miscarriage (12-28 weeks of gestation), premature livebirths (28-37 weeks of gestation), up to 37 weeks|Neonatal Data, Neonatal weight in grams, Neonatal length in centimetres, Apgar 1-minute, 5-minute, 10-minute scores in scores, Number of neonatal complications, after the delivery (an expected average of one month)|Incidents of placental insufficiency, Incidents of pre-eclampsia, intrauterine growth retardation, placental abruption, and intrauterine foetal death, etc., up to 6 weeks post-partum|Incidents of thrombosis/thromboembolism, thrombosis/thromboembolism, From the start of study treatment to 6 weeks post-partum
Evaluate the Efficacy and Safety of Xianglei Tangzu Gao for the Treatment of Wagner Grade II Diabetic Foot Ulcers
NCT Number: NCT06531512
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2|PHASE3
Conditions: Diabetic Foot Ulcer
Sponsor: Oneness Biotech Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 120
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2026-03

Summary:
This is a phase II/III seamless design, randomized, double-blind, paralleled-group, placebo-controlled study to evaluate the efficacy and safety of Xianglei Tangzu Gao for the treatment of Wagner grade II diabetic foot ulcers. The primary endpoint is the proportion of subjects with complete closure of target ulcer during the 16-week treatment phase.

Primary Outcome Measures: The proportion of subjects with complete closure of Target Ulcer, The primary efficacy endpoint for this study is the proportion of subjects with complete closure of Target Ulcer during the 16-week Treatment Phase, which is assessed by investigator., 16-week Treatment Phase
Secondary Outcome Measures: Time to complete closure of Target Ulcer, Time to complete closure of Target Ulcer during the 16-week Treatment Phase, which is assessed by investigator., 16-week Treatment Phase|The mean change for EQ-5D-5L score, The mean change for EQ-5D-5L score between baseline to Day 57, 85, 113 and 197, Day 57, 85, 113 and 197|The proportion of subjects with complete closure of Target Ulcer, The proportion of subjects with complete closure of Target Ulcer during the 16-week Treatment Phase, which is assessed by blinded independent review committee., 16-week Treatment Phase
Laser Outcomes Associated With (Holmium Laser Enucleation of the Prostate) HoLEP Procedures
NCT Number: NCT06531473
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Urologic Diseases|Prostate Obstruction
Interventions: PROCEDURE: HoLEP
Sponsor: Northwestern University
Sex: MALE
Age: ADULT, OLDER_ADULT
Enrollment: 300
Study Design: Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: SINGLE (PARTICIPANT)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-03-04
Completion Date: 2025-08-30
Locations: Northwestern Medicine, Chicago, Illinois, 60611, United States

Summary:
The primary aim is to assess the impact of laser setting frequency and wattage during holmium laser enucleation of the prostate. There is currently no gold-standard laser settings for HoLEP procedures. In the investigator's current high-volume practice, the following settings for enucleation are: 2j 50hz. These settings are conventional settings, but there is no literature to prove optimal laser settings. The investigators hypothesizes that utilization of higher laser settings may be associated with a clinically significant (defined as \> 10%) decrease in procedural time without any detrimental postoperative outcomes, and a utilization of lower laser settings may be associated with a clinically significant (defined as \>10%) reduction in postoperative irritative voiding symptoms without any detrimental postoperative outcomes.

Primary Outcome Measures: Identifying Outcomes of 40 hz, 50 hz and 60 hz laser setting groups during Holmium Laser Enucleation of the Prostate., Comparing operative outcomes between the 40 hz, 50 hz and 60 hz laser setting groups., 2 years
Nutritional Therapy Enriched With Omega-3 in Patients With Lung Resection
NCT Number: NCT06531460
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Lung Cancer|Surgery
Interventions: DIETARY_SUPPLEMENT: Fish oil enteral supplementation|DIETARY_SUPPLEMENT: Fish oil oral supplementation|DIETARY_SUPPLEMENT: Enteral nutrition without fish oil|DIETARY_SUPPLEMENT: Oral nutritional supplement without fish oil
Sponsor: National Institute of Respiratory Diseases, Mexico
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 310
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-07-25
Completion Date: 2027-07
Locations: National Institute of Respiratory Diseases, Mexico City, 14080, Mexico

Summary:
The aim of this study is to analyze the effect of enriched formula with omega-3 in the 30-day incidence infection and inflammatory response following lung resection surgery in lung cancer patients.

Primary Outcome Measures: 30-day incidence infection, Incidence of infectious complications after surgery diagnosed using any of these criteria:

Infection of surgery wound confirmed by culture Infection confirmed by blood culture Pneumonia developed after surgery confirmed by chest x Ray., 30-day incidence infection following lung resection in lung cancer patients.
Secondary Outcome Measures: Changes in prostaglandin E2, Measured in serum sample made by Enzyme-linked immunosorbent assay (ELISA)., At the beginning of nutritional therapy and at day-4 following surgery|Changes in Interleukin-6, Measured in serum sample made by Enzyme-linked immunosorbent assay (ELISA)., At the beginning of nutritional therapy and at day-4 following surgery|Changes in Tumor Necrosis Factor Alpha (TNF-α), Measured in serum sample made by Enzyme-linked immunosorbent assay (ELISA)., At the beginning of nutritional therapy and at day-4 following surgery|Number of participants with therapeutic antibiotics prescription, Frequency of therapeutic antibiotics prescription will be collected from medical records and medication administration registers., During the hospital stay until 30-day|Hospital lenght of stay, Number of calendar days that elapsed since hospital admission to the day of hospital discharge, During the hospital stay until 90-day
First-line Gemcitabine Plus Cisplatin in Locally Advanced (IIIC Stage) Breast Cancer Patients
NCT Number: NCT06531447
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Breast Cancer
Interventions: DRUG: Cisplatin|DRUG: Gemcitabine|DRUG: Doxorubicin|DRUG: Cyclophosphamide|DRUG: Paclitaxel
Sponsor: The National Center of Oncology, Azerbaijan
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2014-05
Completion Date: 2027-05
Locations: Elchin Mansurov, Baku, AZ1011, Azerbaijan

Summary:
The goal of the study is to investigate of the prognostics and predictive role of TUBB3 expression in locally advanced breast cancer

Primary Outcome Measures: Clinical tumor regression rate, Chemotherapy combination Gemcitabine with Cisplatin, 4 months
Secondary Outcome Measures: Increasing PFS and OS, Observation after chemotherapy, 5 years and 10 years
Establishing Best Treatment Strategy for T4 Esophageal Cancer
NCT Number: NCT06531434
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Esophageal Cancer TNM Staging Primary Tumor (T) T4
Interventions: COMBINATION_PRODUCT: "Docetaxel", "Cisplatin", "fluorouracil", "Radiation"
Sponsor: National Cheng-Kung University Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 22
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2026-12-31
Locations: National Cheng Kung University Hospital, Tainan, 704302, Taiwan

Summary:
The goal of this clinical trial is to investigate the safety and efficacy of a new treatment approach for T4-stage esophageal cancer, which involves chemoradiotherapy after induction chemotherapy. The main questions it aims to answer are:

* Does the new induction chemotherapy followed by chemoradiation reduce esophageal perforation rate?
* Does the new induction chemotherapy followed by chemoradiation increase treatment response rate and patient survival? Researchers will analyze the above data to see if the new treatment approach works to treat T4 esophageal cancer.

Participants will:

* Receive induction chemotherapy for 4 to 8 cycles, followed by chemoradiation therapy if downstage to T3
* Visit the clinic once every week for checkups and tests
* Keep a diary of their symptoms

Primary Outcome Measures: Overall response rate of the treatment, Overall response rate = complete response (CR) rate + partial response (PR) rate., At week 8, week 16, and 4 weeks after completion of concurrent chemoradiotherapy (CCRT).|Duration of response (DOR), Defined as the time from CR or PR to the time of disease progression or death., At week 8, week 16, and 4 weeks after completion of CCRT. Thereafter, every 3 months.
Secondary Outcome Measures: Esophageal perforation rate, Detected by bronchoscopy or CT scan., At week 8, week 16, and 4 weeks after completion of CCRT. And at anytime when participants suffer from symptoms in suspicious of esophageal perforation, eg. chest pain, hemoptysis, and fever.|Adverse events of treatment, Any adverse events of chemotherapy or CCRT., During treatment (up to 24 weeks)|Progression-free survival, Defined as the time from diagnosis to the time of disease progression or death., At week 8, week 16, and 4 weeks after completion of CCRT. Thereafter, every 3 months.|Overall survival time, Defined as the time from diagnosis to the time of death., At week 8, week 16, and 4 weeks after completion of CCRT. Thereafter, every 3 months.
Use of Equity Report Cards to Mitigate Disparities in Emergency Medical Services (EMS) Care for Injured Children
NCT Number: NCT06531421
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Pain, Acute
Interventions: OTHER: Equity Report Cards
Sponsor: Children's National Research Institute
Collaborators: American Academy of Pediatrics|Doris Duke Charitable Foundation
Sex: ALL
Age: CHILD
Enrollment: 4000
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2024-09
Completion Date: 2025-09
Locations: Children's National Medical Center, Washington, District of Columbia, 20002, United States

Summary:
This trial will assess whether development and sharing of 'Equity Report Cards' focussed on the recognition and treatment of pain for injured children by Emergency Medical Services (EMS) can help decrease disparities by race and ethnicity.

Primary Outcome Measures: Reduction in pain, Proportion of children who have a reduction in pain score, 1 year
Secondary Outcome Measures: Pain score documented, Proportion of children who have a pain score documented by EMS, 1 year|Any analgesia administered, Proportion of children who have any analgesia administered by EMS, 1 year|Opiate analgesia administered, Proportion of children who have opiate analgesia administered by EMS, 1 year
A Study to Evaluate the Efficacy and Safety of Abiprubart in Participants With Sjögren's Disease
NCT Number: NCT06531395
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Sjögrens Disease
Interventions: DRUG: Abiprubart|DRUG: Placebo
Sponsor: Kiniksa Pharmaceuticals, GmbH
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-17
Completion Date: 2027-07
Locations: Omega Research Debary, LLC, DeBary, Florida, 32713, United States|Clinic of Robert Hozman, MD/Clinical Investigation Specialists, Inc., Skokie, Illinois, 60076, United States|Arthritis and Rheumatology Research Institute, PLLC, Allen, Texas, 75013, United States|Arthritis Care of Texas, Corpus Christi, Texas, 78415, United States|Trinity Universal Research Associates, Inc., Plano, Texas, 75024, United States

Summary:
Primary objective of the study is to evaluate the effect of abiprubart on an established systemic disease activity measure for Sjögren's Disease.

Primary Outcome Measures: Change From Baseline in European League Against Rheumatism (EULAR) Sjögren's Syndrome Disease Activity Index (ESSDAI) at Week 24, Baseline, Week 24
Secondary Outcome Measures: Proportion of Sjögren's Tool for Assessing Response (STAR) Responders (≥ 5 points) at Week 24, Week 24|Proportion of STAR Responders (≥ 5 points) Over Time, Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48, 52, 56|Change From Baseline in Stimulated Salivary Flow Rate (mL/min) at Week 24, Baseline, Week 24|Change From Baseline in Stimulated Salivary Flow Rate (mL/min) Over Time, Baseline, Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48, 52, 56|Change From Baseline in Unstimulated Salivary Flow Rate (mL/min) at Week 24, Baseline, Week 24|Change From Baseline in Unstimulated Salivary Flow Rate (mL/min) Over Time, Baseline, Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48, 52, 56|Change From Baseline in EULAR Sjögren's Syndrome Disease Patient Reported Index (ESSPRI) at Week 24, Baseline, Week 24|Change From Baseline in ESSPRI Over Time, Baseline, Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48, 52, 56|Change From Baseline in Schirmer's Test at Week 24, Baseline, Week 24|Change From Baseline in Schirmer's Test Over Time, Baseline, Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48, 52, 56|Change From Baseline in Clinical EULAR Sjögren's Syndrome Disease Activity Index (clinESSDAI) at Week 24, Baseline, Week 24|Change From Baseline in clinESSDAI Over Time, Baseline, Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48, 52, 56|Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-Fatigue) at Week 24, Baseline, Week 24|Change From Baseline in FACIT-Fatigue Over Time, Baseline, Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48, 52, 56|Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D 5L) at Week 24, Baseline, Week 24|Change From Baseline in EQ-5D 5L Over Time, Baseline, Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48, 52, 56
Danish Nurses Attitudes Towards Addressing Sexual Health
NCT Number: NCT06531382
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Sexuality|Communication|Sexual Dysfunction
Interventions: OTHER: Nurses attitudes toward adressing sexual health in patients with cancer
Sponsor: Rigshospitalet, Denmark
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 500
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-01
Completion Date: 2024-08-01
Locations: Rigshospitalet, Copenhagen, Østerbro, 2100, Denmark

Summary:
Health professionals, within the field of cancer, attitude towards addressing sexual health with patients is unknown.

The aim is to investigate the attitudes of Danish cancer nurses towards addressing sexual health in their clinical work, as well as to assess differences in perceived competences and knowledge.

Method: The questionnaire Health professionals Attitudes towards Sexual Health-Danish version (PA-SH-D) is sent out to Danish cancer nurses via the Professional Society for Cancer Nurses. The questionnaire is sent out via a link via the RedCap database.

The questionnaire link is sent out to members of the Professional Association for Cancer Nurses under the Danish Nursing Council, and it is sent out via their membership register.

Primary Outcome Measures: Attitudes toward adressing sexual health, The main outcome measures Danish nurses attitudes toward addressing sexual health in their future professions, and differences in perceived competences and preparedness depending on the professional program.

The measure is a Validated Questionnaire "health care students' attitudes towards addressing sexual health" (PA-SH-D)., July 2024
Efficiency of Autologous Amniotic Fluid Injection in the Healing of Cesarean Section Scar in High-Risk Population
NCT Number: NCT06531356
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: High Risk Pregnancy|Healing Surgical Wounds
Interventions: BIOLOGICAL: autologous amniotic fluid|OTHER: No amniotic fluid injected in skin edges
Sponsor: Kasr El Aini Hospital
Sex: FEMALE
Age: ADULT
Enrollment: 108
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-02-16
Completion Date: 2024-05-20
Locations: kasr Al Aini, Faculty of Medicine, Cairo University, Cairo, Old Cairo, 11562, Egypt

Summary:
The goal of this randomized controlled trial is to investigate the effect of injection of autologous amniotic fluid in the healing of the scar of cesarean section among high-risk population. Investigator's aim is to know : quality of wound healing, rate of infection and time needed for complete healing. Participants will be divided into two groups. All participants will undergo cesarean section. We will inject autologous amniotic fluid in the edges of the wound during skin closure in half of the participants. Wound healing will be assessed at 1st, 2nd and 6th week postoperatively.

Primary Outcome Measures: Quality of wound healing, Scars will be assessed objectively regarding Color, Thickness, Pliability, Exudate in participants and controls, 1,2,6 weeks postoperative
Machine-Learning Based EEG Biomarkers for Personalized Interventions
NCT Number: NCT06531317
Acronym: EEG-INSIGHT
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Neuropathic Pain|Spinal Cord Injuries|Central Neuropathic Pain
Interventions: DEVICE: transcranial Direct Current Stimulation|DIAGNOSTIC_TEST: Electroencephalography
Sponsor: Institut Guttmann
Collaborators: Castellers de la Vila de Gràcia
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 58
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-10-05
Completion Date: 2025-11-07
Locations: Institut Guttmann, Badalona, Barcelona, 08196, Spain

Summary:
The goal of this observational study is to develop a machine learning model to predict the outcome of a transcranial direct current stimulation (tDCS) treatment in patients suffering from neuropathic pain derived from a spinal cord injury. The main question it aims to answer is:

• Can electroencephalography (EEG) and clinical assessment data predict the success of tDCS treatment in neuropathic pain patients?

Participants will:

* Undergo EEG recording sessions to collect brain activity data before treatment.
* Complete clinical assessments, including medical diagnostics and questionnaires focused on factors related to neuropathic pain before and after treatment.

Primary Outcome Measures: Patient Improvement as assessed by a composite score, Composite Score Breakdown:

Neuropathic Pain Symptom Inventory (NPSI)

Items:

* Constant pain intensity: Questions 1, 2, 3, 11, 12 (sum)
* Constant pain persistence/frequency: Question 4
* Pain crisis intensity: Questions 5, 6 (sum)
* Pain crisis frequency: Question 7
* Allodynia: Questions 8, 9, 10 (sum)

Criteria:

* Numerical NPSI items are only used where pre-treatment pain ratings are 4/10 or higher.
* Responder: Any NPSI item shows a 50% or larger reduction.

Brief Pain Inventory (BPI)

Items:

* Pain Interference: Questions 3a - 3g (average)

Criteria:

* Responder: 30% improvement or more.

Summary:

A subject is considered a responder if BOTH of these conditions are met:

1. Improvement of 50% or more in pain intensity or frequency (NPSI).
2. Improvement of 30% or more in pain interference (BPI)., After tDCS treatment (compared to score before tDCS treatment)
Surufatinib Combined With Serplulimab and Standard Chemotherapy as First-line Treatment in Advanced Solid Tumors With Neuroendocrine Differentiation
NCT Number: NCT06531291
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: ESCC|Biliary Tract Cancer|Gastric Cancer|Pancreas Cancer
Interventions: DRUG: Surufatinib|DRUG: Serplulimab|DRUG: standard chemotherapy
Sponsor: RenJi Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-10
Completion Date: 2027-08-09
Locations: Renji hospital, Shanghai, Shanghai, 200127, China

Summary:
Currently, there are no standard treatment and relevant exploration for solid tumors patients with NED. The study aims to explore the efficacy and safety of surufatinib combined with serplulimab and standard chemotherapy in the treatment ofadvanced solid tumors with NED, in order to provide a new treatment option for advanced solid tumors patients with NED.

Primary Outcome Measures: Progression-Free Survival (PFS), time from first-dose to the first documented disease progression or death, approximately 1 years
Secondary Outcome Measures: Objective response rate (ORR), the proportion of patients with complete response or partial response, using RESIST v1.1, approximately 1 years|Disease Control Rate (DCR), the proportion of patients with complete response, partial response or stable disease, using RESIST v1.1, approximately 1 years
Adebelimab Combined With Irinotecan Liposomal Injection, Oxaliplatin, Fluorouracil and Calcium Folinate Are Used in the First-line Treatment of Pancreatic Cancer Liver Metastasis Efficacy and Safety
NCT Number: NCT06531278
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Pancreatic Cancer Metastatic to Liver
Interventions: DRUG: Irinotecan liposome|DRUG: Adebrelimab|DRUG: Oxaliplatin|DRUG: Fluorouracil|DRUG: Calcium folinate
Sponsor: Jiang Long
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-16
Completion Date: 2026-12-31
Locations: Shanghai General Hospital, Shanghai, Shanghai, 200040, China

Summary:
1. Evaluation of adebelimab in combination with irinotecan liposomes, oxaliplatin, fluorouracil, efficacy and safety of leucovorin in the first-line treatment of advanced metastatic pancreatic cancer
2. Construct the model of immunotherapy combined with chemotherapy for the treatment of pancreatic cancer liver metastasis

Primary Outcome Measures: ORR, The proportion of patients whose tumors shrink to a certain amount for a certain period of time and include cases of complete response (CR) and partial response (PR). Calculated as: (CR cases + PR cases) / FAS × 100 (%); FAS (full analysis set) refers to the case of qualified patients, administered more than one case.

Tumor remission rates are calculated according to the RECIST guidelines (version 1.1), Up to 1 year after the treatment
Cryotechnique as a Diagnostic and Therapeutic Tool of Endobronchial Tumors
NCT Number: NCT06531265
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cryotherapy Effect|Bronchial Neoplasms
Interventions: PROCEDURE: Endobronchial cryobiopsy and cryotherapy using flexible bronchoscopy
Sponsor: Sohag University
Collaborators: Cairo University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 35
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2019-07-01
Completion Date: 2022-10-30
Locations: Sohag University, Sohag, 82425, Egypt|Sohag University, Sohag, 82524, Egypt

Summary:
This study was to assess the diagnostic yield and the safety of bronchoscopic cryotechniques in the management of endobronchial tumors.

Primary Outcome Measures: Diagnostic yield, The recording of histopathological diagnosis as revealed by cryobiopsy, within 10 days|Recanalization Success, The measurement of degree of airway recanalization through bronchoscopic evaluation, one day following the procedure
Secondary Outcome Measures: Degree of dyspnea improvement after the procedure, Measurement of degree of dyspnea before and after the procedure using Modified medical research counsil scale for dyspnea (mMRC scale), 2 weeks after the procedure
The Link Between Motor Competence BMI and Physical Fitness School-age Children
NCT Number: NCT06531239
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Children, Only
Sponsor: Riphah International University
Sex: ALL
Age: CHILD
Enrollment: 271
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-05-28
Completion Date: 2024-07-30
Locations: Riphah International University, Lahore, Punjab, 54000, Pakistan

Summary:
The term "physical fitness" in youngsters describes their general health and capacity for movement. It consists of elements including flexibility, muscular strength and endurance, cardiovascular endurance, and body composition. Children that are physically fit can run, jump, climb, and play without becoming fatigued easily. The body mass index is a metric used to determine how much a person weighs in connection to their height.

Motor competence assesses an individual's ability to accomplish various motor skills and movements. The project aims to study the development and competency of motor skills, as well as factors influencing them, such as physical fitness and training. A cross sectional study will be conducted in different schools of Lahore through convenient sampling. Data will be gathered from a healthy population of age 5 to 8 years. Children with dementia and other mental disorders are excluded. BMI and IPAC-SF tools are used for data collection. Various types of physical activities including walking, moderate intensity and vigorous intensity exercises are used. Data will be analyzed by SPSS 26 version.

Primary Outcome Measures: Body Mass Index, To calculate BMI weight machine will be used height we use inches tap in inches and converted it into meters respectively., 8 weeks|Physical fitness, International Physical Activity will be used Questionnaire - Short Form. The questionnaire asks about the frequency and time of various types of physical activities, including walking, moderate-intensity activities, and vigorous-intensity activities. There are two forms of output from scoring the IPAQ.mild one, moderate two, severe three., 8 weeks|Motor competence, locomotion skills (run, gallop, hop, leap, horizontal jump, slide), and six object control will be used, 8 weeks
Difficult Colonoscopy and Personality Traits
NCT Number: NCT06531226
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Colorectal Disorders
Interventions: OTHER: Fill in personality questionnaires
Sponsor: Qilu Hospital of Shandong University
Sex: ALL
Age: ADULT
Enrollment: 450
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-30
Completion Date: 2025-05-01
Locations: Qilu Hospital of Shandong University, Jinan, Shandong, 250000, China

Summary:
The cecal intubation time (CIT) refers to the time required for the tip of the colonoscope to reach the cecum from passing through the anus. A prolonged CIT is considered a marker of difficulty in colonoscopy. CIT greater than 10 minutes is considered a difficult colonoscopy. Studies have identified factors that influence CIT, including age, gender, body mass index (BMI), waist circumference, bowel preparation, prior abdominal surgery, etc. Personality traits have been found to be associated with the onset of many diseases, such as hypertension and A-type personality, depression and neurotic personality. According to the Big Five personality theory, personality can be decomposed into five dimensions: openness (O), conscientiousness (C), extraversion (E), agreeableness (A), and neuroticism (N). There is a lack of research on the association between personality traits and colonoscopy insertion time, and the purpose of this study is to investigate whether personality, BMI, age, gender, anxiety and depression index, metabolic diseases, and abdominal pelvic surgery history lead to prolonged colonoscopy insertion time and difficult colonoscopy, and to identify significant variables as predictors by using machine learning methods to build a clinical diagnostic model to predict colonoscopy insertion time and identify difficult colonoscopy patients.

Primary Outcome Measures: The occurrence of difficult colonoscopy, CIT(cecum insertion time) was applied to evaluate difficult colonoscopy, a prolonged CIT (\>10min) was considered difficult colonoscopy, The evaluation of difficult colonoscopies was performed immediately after the patient completed the questionnaire at the next colonoscopy
Visual Perception Intervention Programmes Impact on Down Syndrome Affiliate Children's Fine Motor and Visual Perception.
NCT Number: NCT06531213
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Down Syndrome
Interventions: OTHER: experimental|OTHER: controlled
Sponsor: Riphah International University
Sex: ALL
Age: CHILD
Enrollment: 34
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-06-01
Completion Date: 2024-08-11
Locations: Riphah International university, Lahore, Punjab, 54000, Pakistan

Summary:
A second copy of chromosome 21 results in Trisomy 21, a genetic disorder commonly referred to as Down syndrome. In addition to physical traits like low muscular tone, upward-slanting eyes, and a flat facial profile, this extra genetic material causes intellectual and developmental difficulties. Even though people with Down syndrome may experience a range of health problems, they can lead happy, fulfilling lives if they receive the right support and care. Individual differences in the illness's severity are significant.

There will be a randomized control trial. People with Down syndrome who are five to nine years old will be screened for this study. Adults with Down syndrome and severe ID will not be eligible to participate in this study. Participants will be selected using

Primary Outcome Measures: Berry Visual Motor Integration, The berry VMI is designed to assess a person's ability to integrate visual and motor skills so that the proper treatment can be provided, 8weeks|Bruininks oseretsky test, BOT-2 measures fine and gross motor proficiency, with subtests that focus on stability, mobility, strength, coordination, and object manipulation., 8weeks
Building of Prognosis Model for Patients With Cirrhosis Based on Sarcopenia Assessed by Deep Learning
NCT Number: NCT06531200
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Cirrhosis, Liver|Sarcopenia
Sponsor: Peking University People's Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-01
Completion Date: 2025-12-31

Summary:
The goal of this observational study is to develop and validate a fully automated imaging deep learning platform for the evaluation of sarcopenia in liver cirrhosis. Based on this model, a new prognostic model for liver cirrhosis incorporating imaging biomarkers such as sarcopenia will be constructed, and its predictive performance will be validated.

Primary Outcome Measures: Liver-related mortality, Causes of liver disease-related mortality include: Hepatitis B virus infection, hepatitis C virus infection, alcohol-induced or toxic liver disease; complications related to liver cirrhosis: ascites or pleural effusion, esophagogastric variceal bleeding, spontaneous bacterial peritonitis or related infections, hepatic encephalopathy or other neuropsychiatric syndromes based on metabolic disorders, hepatorenal syndrome, hepatopulmonary syndrome; liver failure; hepatocellular carcinoma; death or liver transplantation., As of December 31, 2025
Secondary Outcome Measures: All-cause Mortality, Deaths caused by all reasons, including but not limited to those related to liver disease, As of December 31, 2025
Gamification Design in Evidence-Based Education for Clinical Nurses
NCT Number: NCT06531187
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Nursing Education|Evidence-Based Practice
Interventions: OTHER: Evidence-Based Practice (EBP) Teaching
Sponsor: Ling-Yu Chien
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 102
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2020-04-09
Completion Date: 2022-07-12
Locations: National Defense Medical Center, Taipei, Taiwan

Summary:
The goal of this study is to compare the effectiveness of gamification versus group discussion in evidence-based practice (EBP) education for clinical nurses. It aims to improve learning outcomes and clinical application of EBP.

Primary Outcome Measures: EBP Competence, Measured using the ACE tool developed by Ilic et al. (2014)., Baseline, immediately after the workshop, and 6 months follow-up|Self-Efficacy and attitudes, Assessed using the Taipei Evidence-Based Practice Questionnaire (TEBPQ) (Chen et al., 2014)., Baseline, immediately after the workshop, and 6 months follow-up|Participant Satisfaction with EBP Teaching, Measured using a questionnaire designed specifically for this study., immediately after the workshop|practicing applicability, The patient care report was then submitted for a panel of experts' review., 6 months follow-up
Secondary Outcome Measures: Cognitive Load, Assessed using items referenced from Albarqouni et al. (2018)., Baseline, and 6 months follow-up|Barriers, Measured using the Chinese Evidence-Based Practice Scales (Wang et al., 2012)., Baseline, and 6 months follow-up