pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Evaluating the Impact of a Photoaging App Versus School-Based Educational Intervention on Adolescents' Knowledge, and Attitudes Towards Tobacco Use
NCT Number: NCT06483763
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Tobacco Use Cessation|Smoking Cessation|Smoking Prevention
Interventions: OTHER: SmokerFace App from the Education Against Tobacco (EAT) program|OTHER: The use of standardized school-based educational module
Sponsor: Sultan Qaboos University
Sex: MALE
Age: CHILD, ADULT
Enrollment: 227
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: PREVENTION
Start Date: 2024-02-01
Completion Date: 2024-05-31
Locations: National University of Science and Technology, Sohar, Oman

Summary:
Tobacco use is a leading cause of preventable morbidity and mortality worldwide. It has been estimated that by 2030, tobacco use will cause approximately 10 million deaths per year worldwide, with 70% of those occurring in low- and middle-income countries. Oman, a country in the Arabian Peninsula, is not immune to this global health problem. Tobacco use is prevalent among young people in Oman, and efforts to prevent and control tobacco use among youth are a public health priority.

This study employs a cluster randomized controlled trial design to assess the impact of a photo-gaining app versus a structured educational intervention on tobacco knowledge and attitudes among adolescents in Sohar, Oman. Boys' public schools serve as clusters, with students in grades 9 to 12 as participants. Schools are randomly assigned to either an intervention or control group. The intervention, facilitated by medical students trained at a local university, involves using the SmokerFace App to demonstrate the effects of smoking via photo-aging technology. The control group receives a standardized educational module endorsed by the World Health Organization. Primary outcomes focus on comparing tobacco knowledge levels between groups, while secondary outcomes examine attitudes towards tobacco use. Pre-intervention and post-intervention assessments are conducted using the modified WHO Global Youth Tobacco Survey. Randomization is implemented in two stages to ensure balance, and efforts are made to maintain blinding among outcome assessors and data analysts.

The proposed study is a cluster randomized trial aimed at evaluating the impact of a photo-aging app versus structured educational intervention on knowledge and attitude towards tobacco use and tobacco consumption habits among Omani adolescents. The results of this study will be important for developing effective strategies for preventing tobacco use among youth in Oman and other countries with similar socio-cultural contexts.

Primary Outcome Measures: The difference in the level of knowledge regarding the harmful effects of tobacco use between the intervention and control groups using the GYTS Scale, 12 Weeks
Secondary Outcome Measures: The difference in the attitudes towards tobacco use between the intervention and control groups using the GYTS Scale, 12 weeks
Human Albumin Infusion in Liver Cirrhosis and Overt Hepatic Encephalopathy (HACHE)
NCT Number: NCT06483737
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Overt Hepatic Encephalopathy
Interventions: DRUG: Human albumin infusion at a modified dosage|DRUG: Human albumin infusion at a routine dosage|DRUG: Lactulose|DRUG: Rifaximin|DRUG: Ornithine Aspartate|DRUG: Branched-Chain Amino Acids|DRUG: Arginine
Sponsor: General Hospital of Shenyang Military Region
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 174
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-01
Completion Date: 2027-06-30
Locations: Department of Gastroenterology, General Hospital of Northern Theater Command (formerly called General Hospital of Shenyang Military Area), Shenyang, Liaoning, China

Summary:
Hepatic encephalopathy (HE), a fatal complication of decompensated cirrhosis, is characterized as neurocognitive dysfunction. Emerging evidence suggests the potential role of human albumin infusion for the treatment of HE, but the optimal dosage is obscure. Herein, a randomized controlled trial (RCT) aims to compare the efficacy of human albumin infusion at different dosages in cirrhotic patients with overt HE.

Primary Outcome Measures: Change of overt HE., The change of HE is defined as a decrease or an increase of at least one grade of the West Haven criteria after treatment., 3-5 days
Secondary Outcome Measures: Reversal of overt HE., The reversal of HE is defined as clinical symptoms of overt HE disappear after treatment., 3-5 days|Recurrence of overt HE., Clinical symptoms related to overt HE recur and can be diagnosed with overt HE again according to the West Haven criteria., 3 months|Adverse events, Adverse events will be monitored, including allergy, heart failure, pulmonary edema, acute hemolysis, renal dysfunction, and neuropsychiatric abnormalities., 3 months|Survival, All participants will be followed by telephone to record survival status, including the major cause and date of death., 3 months
Comparison Between Cervical Tourniquet and Uterine Artery Ligation Prior to Segmental Resection Approach
NCT Number: NCT06483724
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Placenta Accreta Spectrum
Interventions: PROCEDURE: cervical tourniquet|PROCEDURE: uterine artery ligation
Sponsor: Minia University
Sex: FEMALE
Age: ADULT
Enrollment: 82
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-01
Completion Date: 2025-05-01

Summary:
The study will compare a modified surgical approach for preserving fertility and minimizing hemorrhage in morbidly adherent placenta during cesarean section with a cervical tourniquet against uterine artery ligation.

Primary Outcome Measures: operation time, recording total time of the surgery, intraoperative|repair time, recording length of defect repair from placental separation until uterine wall closure, intraoperative|Estimated blood loss, recording amount of blood loss, intraoperative|packed red blood cells transfusion, recording amount of red blood cell transfused, intraoperative until 24 hours after surgery|fresh frozen plasma (FFP) transfusion, recording amount of FFP transfusion, intraoperative until 24 hours postoperative|Number of Participants who had Bladder injuries, Number of Participants who had Bladder injuries, intraoperative until 2 weeks post operative|Number of Participants who had ureteral injuries, Number of Participants who had ureteral injuries, intraoperative until 2 weeks post operative|Number of Participants who had bowel injury, Number of Participants who had bowel injury, intraoperative until 2 weeks post operative|surgical site infection, record the presence of wound infection, 24 hours until 1 month after surgery|urine output, recording amount of urine output, intraoperative|internal iliac artery ligation, recording if the internal iliac artery ligated whether it was unilateral or bilateral, intraoperative|pre-operative hemoglobin, recording amount of hemoglobin, preoperative|post-operative hemoglobin, recording amount of hemoglobin, postoperative within 6 hours from surgery|hospital stay, recording duration of hospital stay after surgery, postoperative until 10 days after surgery|ICU admission, recording the number of patients admitted to the ICU, immediate postoperative until 5 days after surgery|HDU high dependency unit admission, recording the number of patients admitted to high dependency unit, postoperative until 10 days after surgery|surgical diagnosis, strategy to preserving the uterus when managing placenta accreta versus hysterectomy, intraoperative
Reducing Barriers to Lifestyle Modification for Newly Diagnosed MASLD
NCT Number: NCT06483711
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Metabolic Dysfunction-associated Steatotic Liver Disease
Interventions: OTHER: Lifestyle Kit
Sponsor: Stanford University
Sex: ALL
Age: CHILD
Enrollment: 50
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-07-10
Completion Date: 2027-07-30

Summary:
Metabolic dysfunction-associated steatotic liver disease (MASLD) is the most common cause of liver disease in the world. It is estimated that 38% of American children with obesity have steatotic liver disease. Patients of Hispanic ethnicity are disproportionately at risk of developing MASLD. This study intends to provide insight to barriers of recommended care for pediatric patients with Hispanic ethnicity and a new diagnosis of MASLD. The investigators propose to augment existing structural barriers related to health literacy, food accessibility and dietary knowledge, and access to safe physical activity through a healthy lifestyle toolkit and individualized nutritional counseling.

Primary Outcome Measures: Number of Social Determinants of Health Impacting Participants, Social Determinants of Health Screener will identify the presence of food, housing, and/or transportation insecurity., Baseline and month 3 or 6 depending on when the participant's follow up appointment with the physician is scheduled.
Secondary Outcome Measures: Mean Change from Baseline AST at 3 or 6 month follow-up appointment, AST lab value, Baseline and month 3 or 6 depending on when the participant's follow up appointment with the physician is scheduled.|Mean Change from Baseline ALT at 3 or 6 month follow-up appointment, ALT Lab value, Baseline and month 3 or 6 depending on when the participant's follow up appointment with the physician is scheduled.|Mean Change from Baseline GGT at 3 or 6 month follow-up appointment, GGT Lab value, Baseline and month 3 or 6 depending on when the participant's follow up appointment with the physician is scheduled.|Mean BMI Change from Baseline at 3 or 6 month follow-up appointment, BMI, Baseline and month 3 or 6 depending on when the participant's follow up appointment with the physician is scheduled.|Mean Weight Change from Baseline at 3 or 6 month follow-up appointment, weight, Baseline and month 3 or 6 depending on when the participant's follow up appointment with the physician is scheduled.|Socioeconomic status of Participants participating in the study, Socioeconomic status, Baseline and month 3 or 6 depending on when the participant's follow up appointment with the physician is scheduled.|Ethnic background of Participants participating in the study, ethnic background, Baseline and month 3 or 6 depending on when the participant's follow up appointment with the physician is scheduled.|Primary language of Participants participating in the study, primary language, Baseline and month 3 or 6 depending on when the participant's follow up appointment with the physician is scheduled.
Real-world Clinical Outcomes of Patients With Early-stage Lung Cancer After the Surgery
NCT Number: NCT06483698
Acronym: EarlyLC-RW
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Lung Cancer
Interventions: OTHER: Sublobar resection|OTHER: Lobectomy
Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-03-01
Completion Date: 2034-12
Locations: Shugeng Gao, Beijing, Beijing, 100020, China

Summary:
The goal of this observational study is to evaluate the efficacy and long-term clinical outcomes of early-stage lung cancer patients who have received surgery using the real-world data. The main questions it aims to answer are:

* What is the best surgical strategy for patients with early-stage lung cancer?
* What are the risk factors for early-stage lung cancer? Participants will receive surgery and the study will analyze the real-world data.

Primary Outcome Measures: Disease-free survival(DFS), Defined as the time from the date of randomization until the date of disease recurrence or death (by any cause in the absence of recurrence)., Defined as the time from the date of surgery until the date of first documented progression or death (by any cause in the absence of recurrence), whichever came first, assessed up to 10 years.
Secondary Outcome Measures: Overall Survival (OS), OS is defined as the time from surgery time until death from any cause., From date of diagnosis until the date of death from any cause, whichever came first, assessed up to 10 years.|5-year Overall Survival (overall survival) Rate, The time from surgery time until death from any cause, estimated from a Kaplan Meier plot of OS at the time of the primary analysis., From date of surgery until date of death due to any cause. Assessed at 5 years.|Patterns of Relapse, Relapse was defined as disease recurrence at any site., Within 10 years after surgery|Perioperative Complication rate, Complications after the surgery, Within 6 months after surgery
Radiopharmaceuticals Analysis for Detailed Insights And INternational Tracking of Safety
NCT Number: NCT06483685
Acronym: RADIANTS
Status: ACTIVE_NOT_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Cancer|Side Effect of Drug
Interventions: DRUG: Radiopharmaceuticals drugs
Sponsor: University Hospital, Caen
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 500000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-05-30
Completion Date: 2024-08-01
Locations: Caen Normandy University Hospital, Caen, Normandy, 14033, France

Summary:
Little is known about cancer therapy-related radiopharmaceuticals drugs safety. Here the investigators use VigiBase (http://www.vigiaccess.org/), the World Health Organization (WHO) database of individual safety case reports, to identify and describe cases of cancer therapy-related radiopharmaceuticals drugs.

Primary Outcome Measures: Toxicity of Radiopharmaceuticals drugs, Identification and report of toxicities of radiopharmaceuticals drugs. The research includes the report with MedDRA terms: System organ class (SOC), Preferred terms (PT), High level group term (HLGT), High level term (HLT), Case reported in the World Health Organization (WHO) of individual safety case reports through study completion, an average 5 years
Secondary Outcome Measures: Individual safety case reports parameters, weight in kilograms, height in meters, age in years, country, date of report in years, co-medication in active ingredients name, sex (male / female), severity (yes or no), death reported (yes or no), reporter qualification, action taken with drug, outcome (recovered, not recovered, role of co-medication (suspect, concomittant, unknown), drugs doses (MegaBecquerels, milligrams, grams, international units, milliliters), route of administration. Date of suspected drug administration, Start date and end date of reported adverse events. Dechallenge of suspected drugs (yes , no, unknown), Rechallenge of suspected drugs (yes , no, unknown)., Through study completion, an average 5 years
Evaluation of the Stability of Sulfur Volatile Compounds From Exhaled Air for Halitosis Diagnosis
NCT Number: NCT06483646
Acronym: HALITOSIX
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Halitosis
Interventions: OTHER: Gaseous sampling:
Sponsor: University Hospital, Strasbourg, France
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-10-01
Completion Date: 2025-09-01

Summary:
Halitosis or bad breath is a problem affecting 30% of the world's population. There are many causes, and oral pathologies, including periodontitis, are the main etiology. In order to make a diagnosis, a clinical interview is necessary to distinguish true halitosis from psychological halitosis. In addition, a measurement of volatile sulfur compounds (VSC), the main molecules involved in bad breath, is necessary. This is done during the consultation by measuring the concentration of VSCs in exhaled air. However, few private practices or hospitals have the necessary equipment to measure VSC. As a result, patients are often obliged to travel long distances to obtain a consultation including this specific VSC analysis. The aim of this study is to evaluate the stability of VSC values obtained in gaseous samples up to 7 days after sampling, in order to assess the clinical relevance of analyzing samples at a distance from sampling. The clinical aim is to determine whether self-sampling by the patient at home and extemporaneous analysis could be considered in the diagnosis of halitosis.

Primary Outcome Measures: H2S measurement, Analysis will be made at Day 0 and Day 7
Effects of Combining Different Exercise Modes With CPT on Vascular Function and Sleep Quality in Female University Students With SD
NCT Number: NCT06483633
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Sleep Quality|Vascular Function
Interventions: BEHAVIORAL: MICT + CPT, HIIT + CPT, SIT + CPT
Sponsor: Beijing Sport University
Sex: FEMALE
Age: ADULT
Enrollment: 28
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: CROSSOVER|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2022-08-01
Completion Date: 2022-12-31
Locations: School of Sports Medicine and Rehabilitation, Beijing Sport University, Beijing, China

Summary:
Fourteen female college students with sleep disorders (SD) and fourteen with good sleep status were recruited, divided into sleep disorder group (SDG) and control group (CG). Both groups underwent moderate-intensity continuous training (MICT), high-intensity interval training (HIIT), and sprint interval training (SIT). Immediately after exercise, Cold Pressor Test (CPT) was administered, vascular indicators were measured immediately and 30 minutes later. The next day after exercise, participants completed the Pittsburgh sleep quality index (PSQI). Each exercise mode had a washout period of at least 7 days.

Primary Outcome Measures: Pittsburgh Sleep Quality Index, The change of Pittsburgh Sleep Quality Index (PSQI) before and after the intervention, Pittsburgh Sleep Quality Index include: specifically PSQI total score, sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbances, and daytime functioning., The next morning following each intervention, within 24 hours post-intervention|Ankle-brachial pulse wave velocity (baPWV), The change of baPWV before and after intervention., Immediately after each intervention and 30 minutes later.|Ankle-brachial index (ABI), The change of ABI before and after intervention., Immediately after each intervention and 30 minutes later.
Secondary Outcome Measures: Blood pressure, The change of blood pressure before and after intervention., Immediately after each intervention and 30 minutes later.
Comparison of M-TAPA and TAP Blocks on Postoperative Analgesia in Laparoscopic Inguinal Hernia Surgeries
NCT Number: NCT06483607
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Post Operative Pain
Interventions: OTHER: M-TAPA block with bupivacaine 25%|OTHER: TAP block with bupivacaine 25%
Sponsor: Cumhuriyet University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 90
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: OTHER
Start Date: 2024-07
Completion Date: 2024-09

Summary:
The goal of this study is to compare the analgesic efficacy of M-TAPA block and TAP block in patients undergoing laparoscopic inguinal hernia surgeries.

Primary Outcome Measures: Comparing the numerical rating scale scores, Numerical rating scale will be used for pain assessment. The scores of the numerical rating scale changes between 0 to 10 points. 10 points mean "the most severe pain that the patient ever had". 0 point means "there is no pain." Higher scores mean worse outcome., Postoperative 24 hours
Secondary Outcome Measures: Comparing total tramadol consumption, Postoperative analgesic need, Postoperative 24 hours
Prediction and Prognostic Analysis of Liver Abscess Formation After Transcatheter Arterial Chemoembolization for Hepatocellular Carcinoma (CHANCE 2407)
NCT Number: NCT06483594
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: TACE|HCC - Hepatocellular Carcinoma|Liver Abscess
Sponsor: Shengjing Hospital
Collaborators: First Hospital of China Medical University|Zhongda Hospital|Changzhou No.2 People's Hospital|Tianjin Medical University General Hospital|Huazhong University of Science and Technology
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 400
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-30
Completion Date: 2025-06-30

Summary:
Liver abscess is a rare but serious complication of hepatocellular carcinoma after TACE, with an incidence of less than 1% reported in previous literature. Studies have shown that history of biliary tract disease, tumor size, embolization materials and embolization endpoint selection may be related to the occurrence of abscess. In recent years, with the wide application of targeted and immune drugs, there have been reports of multiple cases of liver abscess after single target immunotherapy for liver cancer, and there have also been studies showing that TACE combined with targeted immunotherapy can significantly increase the degree of liquefaction necrosis and increase the risk of liver abscess. However, these studies are single-center reports with small sample size and low level of evidence. Therefore, it is of great clinical significance to explore the risk factors of liver abscess after TACE and build a prediction model by using multi-center and large sample data. The formation of liver abscess after TACE means a large range of tissue liquefaction necrosis. There are reports of high incidence of early recurrence and metastasis of liquefaction necrosis. Some studies also show that tumor necrosis is more complete when liver abscess is combined with complete remission. In previous studies, ORR in patients with liver cancer complicated with liver abscess ranged from 18.75%-100%, with significant differences in reports from different centers. The effect of specific abscess formation on TACE efficacy of liver cancer remains to be determined. Therefore, the second research focus of this project is to explore the effect of liver abscess formation after TACE on prognosis of liver cancer.

Primary Outcome Measures: Whether combined targeted therapy was a risk factor for liver abscess formation after TACE., The targeted treatment of patients with and without liver abscess after TACE was collected, and conclusion was drawn by univariate and multivariate analysis., one year|Whether combined immunotherapy was a risk factor for liver abscess formation after TACE., The immunotherapy of patients with and without liver abscess after TACE was collected, and conclusion was drawn by univariate and multivariate analysis., one year
Secondary Outcome Measures: Survival time of patients with liver abscess formation after TACE., Patients with liver abscess formation after TACE were followed up regularly to determine their survival status., one year
Comparison of M-TAPA and TAP Blocks on Postoperative Analgesia in Laparoscopic Appendectomy Surgeries
NCT Number: NCT06483581
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Post Operative Pain
Interventions: OTHER: M-TAPA block with bupivacaine 25%|OTHER: TAP block with bupivacaine 25%
Sponsor: Cumhuriyet University
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: OTHER
Start Date: 2024-07
Completion Date: 2024-09

Summary:
The goal of this study is to compare the analgesic efficacy of M-TAPA block and TAP block in patients undergoing laparoscopic appendectomy surgeries

Primary Outcome Measures: Comparing the numerical rating scale scores, Numerical rating scale will be used for pain assessment. The scores of the numerical rating scale changes between 0 to 10 points. 10 points mean "the most severe pain that the patient ever had". 0 point means "there is no pain." Higher scores mean worse outcome., Postoperative 24 hours
Secondary Outcome Measures: Comparing total tramadol consumption, Postoperative analgesic need, Postoperative 24 hours
Bionenergetic Balance During CVVH
NCT Number: NCT06483542
Acronym: BALANCE
Status: ACTIVE_NOT_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Acute Kidney Injury|Continuous Venovenous Hemofiltration|Energy Metabolism|Resting Energy Expenditure|Nutrition Therapy
Interventions: OTHER: bioenergetic balance
Sponsor: Universitair Ziekenhuis Brussel
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-02-01
Completion Date: 2024-09-30
Locations: Universitair ziekenhuis Brussel, Jette, Vlaams Brabant, 1090, Belgium

Summary:
The bioenergetic balance is the sum of energy exchanged during CRRT and is mostly defined by citrate glucose and lactate. When CRRT was performed with the older dialysis fluids, glucose and lactate could be an important source of energy next to citrate when used as predilution (6, 7). During continuous venovenous hemofiltration (CVVH), a subgroup of CRRT which is performed with the newer dialysis fluids without lactate or glucose as advocated by the KDIGOguidelines, glucose and in a minor way lactate mostly induce a loss of energy. The first aim is to determine how this bioenergetic balance impacts energy need compared to the measured energy with indirect calorimetry and how nutrition therapy needs to be adapted.

Also, disease specific predicting equation have been created for patients suffering from acute kidney injury treated with renal replacement therapy. How this predicting equation and other existing predicting equations agree with the measured REE has not been validated yet. The second aim is to determine how predictive equations correlate with measured REE in patients treated with CVVH.

Primary Outcome Measures: Energy, expressed in Kcal, during study completion, on average 4weeks
Secondary Outcome Measures: resting energy expenditure, expressed in Kcal, during study completion, on average 4weeks|protein to energy ratio, expressed in gr/Kcal, during study completion, on average 4weeks
Post-operative Quality of Life After AAA Management: EVAR Versus Open Repair
NCT Number: NCT06483516
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Post Operative Quality of Life After AAA Surgery
Interventions: PROCEDURE: Open repair|PROCEDURE: Endovascular repair
Sponsor: University Paul Sabatier of Toulouse
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Observational Model: |Time Perspective: p
Start Date: 2021-01-01
Completion Date: 2025-12-30
Locations: Hostalrich, Toulouse, 31400, France

Summary:
The treatment of AAA has been revolutionised by minimally invasive techniques that allow patients to return home more quickly and have a reputation for having a low impact on their quality of life.

However, no study has looked at the quality of life of patients treated for AAA using open or endovascular surgery, using a scale adapted to post-operative follow-up.

The investigators conducted a single-centre prospective observational study to assess the quality of life of patients undergoing AAA surgery by endovascular exclusion or open surgery

Primary Outcome Measures: Quality of life evolution, Qor15 score filled by the patient, Day before surgery/ the day of discharge home (up to 1 month) / 1 month after surgery post operative consultation/ 6 months after surgery post operative consultation
Secondary Outcome Measures: Post operative mortality, Death after surgery, day 30|early Reintervention, New operation, Day 30|late reintervention, New operation, 3 months, 6 months, yearly
Extra Wide Field of View Lens Study
NCT Number: NCT06483503
Acronym: EFOV
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Colonic Polyp
Interventions: DEVICE: EFOV Colonoscope
Sponsor: Pentax Medical
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08
Completion Date: 2025-03
Locations: RKM 740 Interdisciplinary Care Clinic - Gastroenterology, Düsseldorf, Germany

Summary:
The goal of this observation study is to learn about the feasibility of a new colonoscope which provides the physician an extra-wide field of view during a screening colonoscopy. The main question this study aims to answer is can this new type of colonoscope locate polyps during clinical use in patients.

Patients will undergo a routine colonoscopy for colorectal cancer or polyp surveillance and have one follow-up phone call up to 2 weeks of the colonoscopy.

Primary Outcome Measures: Cecal Intubation Rate, The proportion of procedures in which the cecum was reached., Day 1
Secondary Outcome Measures: Procedure Time, Total procedure time and separated into cecal insertion time, time to reach ileum and withdrawal time., Day 1|Ileum Intubation Rate, Success rate of reaching the Ileum., Day 1|Therapeutic Intervention Success Rate, The ability to collect a biopsy or remove a polyp., Day 1|Mean number of polyps per coloscopy and its detection rate, Count of number of polyps seen during colonoscopy, Day 1|Mean number of adenomas and its detection rate, Count of number of adenomas/sessile serrate lesions defined by pathology, Day 14|Mean number of sessile serrate lesions and its detection rate, Count of number of adenomas/sessile serrate lesions defined by pathology, Day 14|Patient Satisfaction Survey, During a follow-up phone call, the patient will be asked a yes or no question to rate their satisfaction of the procedure., Day 14
Dermatitis During Adjuvant Irradiation for BREAst Cancer:
NCT Number: NCT06483477
Acronym: DAI-BREAC
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Breast Cancer Female
Interventions: OTHER: Standard skin care|DEVICE: Reminder App
Sponsor: University Hospital Schleswig-Holstein
Collaborators: University of Southern Denmark|Medical School Hamburg
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 268
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-09-01
Completion Date: 2026-09-30
Locations: Vejle Hospital, University Hospital of Southern Denmark, Vejle, Southern Denmark, 7100, Denmark|Medical Practice for Radiotherapy and Radiation Oncology, Hannover, Lower Saxony, 30161, Germany|Medical School Hamburg, Schwerin Campus, Schwerin, Mecklenburg-Western Pomerania, 19055, Germany|Malteser Hospital St. Franziskus, Flensburg, Schleswig-Holstein, 24939, Germany|Department of Radiation Oncology, University of Lübeck and University Medical Center Schleswig-Holstein, Lubeck, 23562, Germany

Summary:
In the randomized DAI-BREAC trial, a reminder app will be prospectively tested that reminds breast cancer patients four times each day to perform the required skin care. This will likely contribute to the reduction of grade ≥2 radiation dermatitis in these patients. A total of 268 patients will be randomized to receive standard skin care supported by a reminder app (Arm A) or standard skin care alone (Arm B). Stratification will be done using the three factors treatment volume, radiation boost, and at least one risk factor of dermatitis. Secondary aims include pain (radiation fields), patient satisfaction with the reminder app (Arm A only), impact of the app on the use of health technology (Arm A only), and benefit from support by staff members of the treating Department of Radiation Oncology and/or the UKSH academy regarding the use of the app (Arm A only).

Primary Outcome Measures: Prevention of grade ≥2 radiation dermatitis, Radiation dermatitis will be assessed according to CTCAE v5.0., through study completion, an average of 4 weeks
Secondary Outcome Measures: Pain score, Pain (skin within radiation fields) will be assessed with a visual analogue scale (self-assessment, ranging from 0 = no pain to 10 = maximum pain). Furthermore, the intake of analgesics will be documented., through study completion, an average of 4 weeks|Rate of patient satisfaction with the reminder app, Patient satisfaction with the reminder app will be assessed with a specific questionnaire (Arm A only)., through study completion, an average of 4 weeks|Degree of the impact of the reminder app, Impact of the reminder app on the use of health technology will be assessed with a specific questionnaire (Arm A only)., through study completion, an average of 4 weeks|Rate of patient satisfaction with support, 4. Benefit from support by staff members of the treating Department of Radiation Oncology and/or the UKSH academy regarding the use of the reminder app will be assessed with a specific questionnaire (Arm A only)., through study completion, an average of 4 weeks
Validation of ACS NSQIP Risk Calculator for Predicting Complications After Thoracic Surgery at University Hospital Basel
NCT Number: NCT06483464
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Thoracic
Sponsor: University Hospital, Basel, Switzerland
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 300
Study Design: Observational Model: |Time Perspective: p
Start Date: 2021-05-01
Completion Date: 2023-08-31
Locations: Department of Thoracic Surgery, University Hospital of Basel, Basel, 4031, Switzerland

Summary:
This single-center retrospective research project aims to evaluate whether and what is the significance of the National Surgical Quality Improvement Program of the American College of Surgeons (ACS NSQIP) risk score in thoracic surgery at the University Hospital Basel.

Primary Outcome Measures: Suitability of the ACS NSQIP risk calculator, To evaluate the suitability of the National Surgical Quality Improvement Program of the American College of Surgeons (ACS NSQIP) risk calculator for thoracic surgery, the ACS NSQIP risk score is compared to actual complications.

ACS NSQIP risk score is a tool used to predict the likelihood of postoperative complications and mortality in surgical patients. It is calculated based on a range of preoperative variables, including patient demographics, comorbidities, and the type of surgery being performed. The values of the ACS NSQIP risk score can range from 0 to 100, with higher scores indicating a higher risk of complications and a worse expected outcome., Up to 30 days after surgery
Facilitated Telemedicine in the Catholic Health System
NCT Number: NCT06483451
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: HCV
Sponsor: State University of New York at Buffalo
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07
Completion Date: 2025-12

Summary:
Hepatitis C virus is a leading cause of morbidity and mortality globally with the highest prevalence and incidence among people with opioid use disorder. We aim to establish facilitated telemedicine as a standard of care treatment approach at 3 opioid treatment programs operated by the Catholic Health System. This study is a chart review data analysis to evaluate outcomes of facilitated telemedicine integrated into opioid treatment programs and to evaluate the number of individuals who initiate and complete treatment for hepatitis C virus infection.

Primary Outcome Measures: HCV Treatment Initiation, The time point that HCV treatment is initiated, 1 year|HCV Sustained Virologic Response, The time point that HCV cure (sustained virologic response) is achieved, 1 year
A Biomarker Exploration Study of Precision Treatment in Ovarian Cancer
NCT Number: NCT06483425
Status: ACTIVE_NOT_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Ovarian Cancer|Biomarker
Interventions: GENETIC: Sequencing of DNA, RNA, and Proteins
Sponsor: Tongji Hospital
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 2000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-03-01
Completion Date: 2028-12-01
Locations: Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, 430030, China

Summary:
This clinical trial aims to investigate the role of biomarkers in guiding precision treatment for ovarian cancer. The study will explore the effectiveness of personalized treatment strategies based on specific biomarkers identified in ovarian cancer patients. By analyzing the correlation between biomarker profiles and treatment outcomes, the trial seeks to optimize treatment decisions and improve overall survival rates in ovarian cancer patients.

Primary Outcome Measures: Biomarker explorarion, Blood, tumor, and other samples should be sequenced by RNA-seq, Next-Generation Sequencing, or proteomics to identify specific biomarkers associated with treatment response and prognosis in ovarian cancer., 5 years
An Evaluation of the Tobacco Prevention Toolkit Healthy Futures: Alternative-to-Suspension Vaping Intervention
NCT Number: NCT06483412
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Tobacco Use Cessation|Addiction
Interventions: BEHAVIORAL: Healthy Futures: Alternative-to-Suspension Curriculum
Sponsor: Stanford University
Collaborators: California School-Based Health Alliance
Sex: ALL
Age: CHILD, ADULT
Enrollment: 2540
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (CARE_PROVIDER)|Primary Purpose: PREVENTION
Start Date: 2024-10
Completion Date: 2027-08
Locations: Stanford University, Palo Alto, California, 94304, United States

Summary:
The Healthy Futures: Alternative-to-Suspension Curriculum is a free, online curriculum developed to educate students and provide them with resources to quit tobacco/nicotine use. The investigation aims to estimate the extent to which Healthy Futures: Alternative-to-Suspension changes high school student's knowledge of, attitudes towards, intentions to use, and actual use of tobacco/nicotine.

Primary Outcome Measures: Change in tobacco/nicotine use, Investigator-originated survey measures (questions) ever tobacco/nicotine use and past 30-day tobacco/nicotine use. All students in both arms will be asked to complete a survey at baseline (just before treatment), follow-up 1 (immediately post-intervention), follow-up 2 (6 months after completing intervention), and so on every 6 months for 2.5 years of the study., Baseline, follow-up 1 (following intervention at one year), follow-up 2 (6 months post-intervention), follow-up 3 (6 months past follow-up 2), and follow-up 4 (6 months past follow-up 3) up to 2.5 years of the study.
Secondary Outcome Measures: Change in intention of tobacco/nicotine use scale score, Participants will self-report changes in their intention/susceptibility to use tobacco/nicotine products using a validated four-point scale in a survey. This survey measures changes in intention to use tobacco/nicotine with questions related to the participant's knowledge of and resistance to the use of tobacco/nicotine products.

Susceptibility is measured by the following questions:

1. Have you ever been curious about using an e-cigarette?
2. Do you think that you will try an e-cigarette soon?
3. If one of your best friends were to offer you an e-cigarette, would you use it?"

Response options for all three questions included a four-point scale: "Definitely yes," "Probably yes," "Probably not," and "Definitely not.", Baseline, follow-up 1 (following intervention at one year), follow-up 2 (6 months post intervention), follow-up 3 (6 months past follow-up 2), and follow-up 4 (6 months past follow-up 3) up to 2.5 years of the study.
Research on Nutritional Risk Indexes and Inflammatory Indicators in Postoperative Complications and Prognosis of Epithelial Ovarian Cancer Patients
NCT Number: NCT06483399
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Epithelial Ovarian Cancer
Sponsor: Qinglei Gao
Sex: FEMALE
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 1108
Study Design: Observational Model: |Time Perspective: p
Start Date: 2012-01-01
Completion Date: 2023-02-28

Summary:
The goal of this observational study is to explore the influence and predictive significance of nutritional risk indicators and inflammatory indicators on postoperative complications and prognosis of patients with epithelial ovarian cancer (EOC). The main question it aims to answer is:

Can preoperative nutritional risk and inflammatory indexes predict postoperative complications? Do preoperative nutritional risk and inflammatory indexes better predict the prognosis of patients with epithelial ovarian cancer? Which index is the best predictor of postoperative complications or prognosis for patients?

Primary Outcome Measures: Postoperative Complications, Surgical complications within 30 days after comprehensive staging or cytoreductive surgery recorded according to the Clavien-Dindo grading system, Within 30 days after surgery|Progression-free survival, Interval between first diagnosis and first recurrence, death, or last follow-up, From the date the patient diagnosed with primary ovarian, fallopian tube, or peritoneal cancer to the date of disease progression or death or last follow-up, whichever occurred first, assessed up to 100 months.|Overall survival, Interval between first diagnosis and death, or last follow-up, From the date the patient diagnosed with primary ovarian, fallopian tube, or peritoneal cancer to the date of death or last follow-up, whichever occurred first, assessed up to 100 months.
Pyrotinib and Subcutaneous Preparation of Trastuzumab Combined With Capecitabine Neoadjuvant Therapy for HER2+ Study of Breast Cancer
NCT Number: NCT06483386
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Breast Cancer
Interventions: DRUG: Pyrotinib and Subcutaneous preparation of trastuzumab combined with capecitabine
Sponsor: Tianjin Medical University Cancer Institute and Hospital
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 109
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-15
Completion Date: 2026-12-30

Summary:
Objective: To explore the efficacy and safety of Pyrotinib, trastuzumab subcutaneous preparation and capecitabine neoadjuvant therapy for early HER2+breast cancer.

Administration method: 6 cycles throughout the entire process:

Pyrotinib Maleate Tablets: Continuously administered from the first day of the first course of treatment, 400 Mg/day, orally administered within 30 minutes after breakfast Trastuzumab: Subcutaneous injection, 600mg, d1, q3w Capecitabine: oral, 1000 mg/m2, bid d1-14, q3w Premenopausal goserelin 3.6mg once every 28 days

Primary Outcome Measures: Follow up on postoperative pathological reports for evaluation for Pathological complete response rate (tpCR: ypT0-is/ypN0), Follow up on postoperative pathological reports for evaluation rely onMiller\&Payne principles, 18weeks
Secondary Outcome Measures: Objective response rate (ORR) for treatment, The proportion of patients whose tumor volume has shrunk to a predetermined value and can maintain the minimum time limit requirement, At the end of the second cycle (each cycle is 21 or 28 days)]
A Clinical Study of SPH7854 Granules in Healthy Subjects.
NCT Number: NCT06483373
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: EARLY_PHASE1
Conditions: Inflammatory Bowel Disease
Interventions: DRUG: SPH7854|DRUG: Placebo
Sponsor: Shanghai Pharmaceuticals Holding Co., Ltd
Sex: ALL
Age: ADULT
Enrollment: 111
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-05-28
Completion Date: 2025-12-31
Locations: West China Second University Hospital, Sichuan University, Chengdu, China

Summary:
To evaluate the safety of SPH7854 in healthy subjects.

Primary Outcome Measures: Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs), Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs), Approximately 2 years
Secondary Outcome Measures: PK(Pharmacokinetics):Tmax, Time to peak plasma concentration (Tmax), Approximately 2 years|PK(Pharmacokinetics):Cmax, Maximum serum concentration(Cmax), Approximately 2 years|PK(Pharmacokinetics):AUC, Area under the plasma concentration versus time curve (AUC), Approximately 2 years
Methane and Hydrogen Breath Test for the Diagnosis of Small Intestinal Bacterial Overgrowth
NCT Number: NCT06483360
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Small Intestinal Bacterial Overgrowth
Sponsor: Shanghai Jiao Tong University School of Medicine
Collaborators: First Affiliated Hospital, Sun Yat-Sen University|West China Hospital|First Affiliated Hospital of Kunming Medical University|Second Affiliated Hospital, School of Medicine, Zhejiang University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 750
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-01
Completion Date: 2025-12-31

Summary:
To investigate whether the positive rates of methane and hydrogen breath test were different between the experimental group and the control group.

Primary Outcome Measures: Methane and hydrogen breath test results of experimental and control groups, To investigate whether the positive rates of methane and hydrogen breath test were different between the experimental group and the control group., July 1, 2024 to December 31, 2024
Checkpoint Inhibitor Combinations Therapy as First Line for Inoperable Lung Cancer Via IT
NCT Number: NCT06483347
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Lung Cancer|Inoperable Disease
Interventions: DRUG: ipilimumab+pembrolizumab or ipilimumab+durvalumab, idarubicin, bevacizumab
Sponsor: Second Affiliated Hospital of Guangzhou Medical University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 90
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-04-04
Completion Date: 2033-12-30
Locations: Second Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China

Summary:
This trial is designed to investigate the safety, response rates and survival outcomes of patients with inoperable lung cancer by infusion of CTLA4, PD1 and PDL1 antibodies combination with chemodrug or/and bevacizumab through intra-tumor (IT).

Primary Outcome Measures: Safety of IT delivery of drugs combination treatment, Safety will be assessed by recording all types of advise effects upon and after the treatment., 5 years|Progression-free survival, Progression-free survival (PFS) will be defined as the elapsed time from the first date of study treatment until documented disease progression (as per RECIST 1.1) or death from any cause, whichever is earlier. For patients who remain alive without progression, follow-up time will be censored at the date of last disease assessment., 5 years|Disease control rate, Disease control rate will be defined as objective response rate + steady disease rate., 5 years|Duration of remission (DOR), DOR will be defined as the duration of the cancer remission., 5 years
Secondary Outcome Measures: Overall survival, Overall survival (OS) will be defined as the elapsed time from the enrollment to death from any cause. For surviving patients, follow-up will be censored at the date of last contact (or last date known to be alive). Follow-up for OS will occur every 12 weeks (±1 month) until death or withdrawal of consent from the study., 5 years