pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
First-day Versus Early Drain Removal Following PD: a Randomized Controlled Trial
NCT Number: NCT06468917
Acronym: FIDEL
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Pancreas Fistula Abdominal Drains
Interventions: BEHAVIORAL: 1st day removal of abdominal drain
Sponsor: Casa di Cura Dott. Pederzoli
Collaborators: University of Padova
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 224
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-06-01
Completion Date: 2026-03-30
Locations: Cdcpederzoli, Peschiera Del Garda, Verona, 37019, Italy

Summary:
Pancreatic surgery is a complex discipline with a high risk of post-operative morbidity such as pancreatic fistula (POPF) with variable impact on clinical outcome. Controversies on ID placement have emerged from both randomized and non-randomized clinical studies investigating its possible role in increasing POPF and postoperative morbidity. The optimal timing for drain removal after PD is still a subject of debate: most studies have shown that outcomes are best when ID are removed in postoperative day (POD) 3 when POPF is excluded.

AIM we aim to compare postoperative surgical outcomes after PD in patients with low/medium risk for POPF (ISGPS risk class A-B-C), who undergo POD1 drains removal versus POD3 removal.

Primary aim: 1) grade B/C POPF; 2) post-pancreatectomy hemorrhage (PPH). Secondary aims: occurrence of fluid collection, sepsis, SSI, need for reintervention, length of stay, CD\>3, 90 days mortality, re-admission.

Study Design:

This is a randomized, controlled, open-label study. All patients will be randomized on POD1, using computer-generated randomization codes.

Group A: Drain removal on POD 1 (in case of POD 1 DFA\< 300 U/L) Group B: Drain removal on POD 3 (in case of POD 1 DFA\< 300 U/L)

Primary Outcome Measures: occurrence of one or more pancreas-specific complications, complications are defined according to ISGPS as:1) grade B/C POPF; 2) post-pancreatectomy hemorrhage (PPH)., up to 90 days after surgery
Secondary Outcome Measures: occurrence of general post operative complications, occurrence of fluid collection, sepsis, SSI, need for reintervention, length of stay, CD\>3, 90 days mortality, re-admission, up to 90 days after surgery
Efficacy of Cervical Stabilization Exercises on Hand Grip Strength in Chronic Myofascial Neck Pain
NCT Number: NCT06468904
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Chronic Neck Pain
Interventions: PROCEDURE: cervical stabilization exercises and integrated neuromuscular technique.
Sponsor: Cairo University
Sex: FEMALE
Age: ADULT
Enrollment: 52
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2023-10-01
Completion Date: 2024-08
Locations: Cairo University, Giza, 11251, Egypt|Faculty of physical therapy, Giza, 11251, Egypt

Summary:
The purpose of this study is to examine effect of cervical stabilization exercises on hand grip strength, key pinch strength, pain intensity, pain pressure threshold and hand function in chronic myofascial neck pain patients.

Primary Outcome Measures: primary outcome measure, hand grip strength was measured by hand held dynamometer., up to four weeks
Secondary Outcome Measures: secondary outcome measures, pain pressure threshold was measured by pressure algometer., up to four weeks|secondary outcome measure, hand function was measured by michigan quesstionaire.The Michigan Hand Outcomes Measure comprises 37 items with rating scale ranging 1 to 5. Every single domain was scored and converted to values that range from 0-100. A high score indicates better results, with the exception of pain in which a high score indicates a more intense pain., up to four weeks|secondary outcome measure, pain intensity was measured by visual analogue scale.The level of pain on the VAS was recorded on a 10 cm line distinct at one end 'no pain' and marked at the other end 'the worst pain. Subjects were asked to state their pain level by placing a mark on this horizontal line, up to 4 weeks|secondary outcome measure, pinch strength was measured by pinch gauge, up to four weeks
Analyzing Gait Parameters Among Women With and Without Stress Urinary Incontinence
NCT Number: NCT06468891
Acronym: GPWSUI
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Gait|Stress Urinary Incontinence|Women
Interventions: OTHER: Incontinence Symptom Severity Index|OTHER: Force platform|OTHER: The STT three-dimensional motion analysis (3DMA) system
Sponsor: Cairo University
Sex: FEMALE
Age: ADULT
Enrollment: 124
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-16
Completion Date: 2024-08-30
Locations: Faculty of Physiotherapy, Cairo, 11432, Egypt

Summary:
This study will contribute to the existing body of knowledge on stress urinary incontinence and its impact on gait. The findings may have implications for the development of targeted interventions and rehabilitation strategies to improve mobility and quality of life in women with stress urinary incontinence

Primary Outcome Measures: Incontinence Symptom Severity Index, The Incontinence Symptom Severity Index (ISSI) is a self-assessment instrument used to measure the severity of female urinary storage and voiding symptoms., one day
Secondary Outcome Measures: Force platform, After data collection, the recorded data is analysed to extract various gait parameters. These parameters include: Srtide lengh for left and right lower limbs, Srtide time for left and right lower limbs, Step Cycle Duration (ms), Time of Contact (ms), Swing Duration (ms), Double Support Duration (ms).The findings from the gait analysis are typically documented in a report to be used for statistical analysis., one day|The STT three-dimensional motion analysis (3DMA) system, The STT three-dimensional motion analysis (3DMA) system (STT Systems Company, Zuatzu Business Park, Easo Building, 2nd Floor, San Sebastián, Spain) was used for the assessment of spatiotemporal characteristics of gait. It is an indoor optical system that consists of four cameras, fifteen markers, and computer software for automatic three-dimensional motion capture and analysis. CLINICAL 3DMA V.6.11 is professional software with highly accurate marker tracking. The STT Helen Hayes protocol was used for the gait analysis in this study., one day
Virtual Reality Intervention for Fear of Heights
NCT Number: NCT06468878
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Acrophobia
Interventions: BEHAVIORAL: Exposure Intervention Plus Music Induction|BEHAVIORAL: Exposure Intervention With No Music Induction
Sponsor: Boston University Charles River Campus
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 44
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-08
Completion Date: 2025-05
Locations: Boston University, Boston, Massachusetts, 02215, United States

Summary:
Exposure-based cognitive behavior therapy is an efficacious treatment for acrophobia (fear of heights) and has been delivered effectively in a virtual reality (VR) environment. The present study is designed to evaluate the effects of liked, non-lyrical background music on the efficacy of a brief VR exposure intervention.

Primary Outcome Measures: Acrophobia (Fear of Heights), Assessed using the Acrophobia Questionnaire (AQ) Anxiety Subscale, Comparison of pre-exposure scores to scores from the follow-up survey one week after exposure
Secondary Outcome Measures: Valance, Self-report measure of how participant feels about experiencing high-height environments., Comparison of pre-exposure scores to scores from the follow-up survey one week after exposure|Height-Relevant Interpretations, Assessed using the Heights Interpretation Questionnaire (HIQ), Comparison of pre-exposure scores to scores from the follow-up survey one week after exposure
Glucose Monitoring in Treatment of Postprandial Hypoglycemia After Bariatric Surgery
NCT Number: NCT06468865
Acronym: HypoBar
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Hypoglycemia Non-Diabetic|Bariatric Surgery Candidate
Interventions: DEVICE: Continuous glucose monitor (Dexcom® G7)
Sponsor: Sykehuset i Vestfold HF
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 120
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-02
Completion Date: 2026-12-31
Locations: 1Department of Endocrinology, Obesity and Nutrition, Vestfold Hospital Trust, Tønsberg, Vestfold, 3103, Norway

Summary:
The goal of this clinical trial is to learn if continuous glucose monitoring works to treat postprandial hypoglycaemia in patients who have undergone bariatric surgery. The main question it aims to answer is:

• Is continuous glucose monitoring superior to usual care for prevention of postprandial hypoglycaemia in patients with verified postprandial hypoglycaemia after bariatric surgery?

Researchers will compare continuous glucose monitoring to usual care to see if continuous glucose monitoring works to treat postprandial hypoglycaemia.

Participants will:

* Use a continuous glucose monitor for 5 weeks or use no continuous glucose monitor for 5 weeks. During week 6 both groups will wear a continuous glucose monitor, but the patients who have not been wearing a continuous glucose monitor will wear a blinded continuous glucose monitor.
* Visit the clinic 3 times.
* Register symptoms of hypoglycaemia, answer questionnaires, keep a food diary, measure weight and body composition and take blood samples.

Primary Outcome Measures: • Difference between the two treatment arms in change in weekly diurnal time spent with hypoglycaemia (interstitial glucose <3.0 mmol/L) from baseline to week 6, measured with a continuous glucose monitor., Interstitial glucose is measured for 7 days during the baseline week (week 0) and 7 days during week 6., Baseline (week 0) and week 6
Secondary Outcome Measures: • Difference between the two treatment arms in change in weekly diurnal time spent with hypoglycaemia (interstitial glucose <3.9 mmol/L) from baseline to week 6, measured with a continuous glucose monitor., Interstitial glucose is measured for 7 days during the baseline week (week 0) and 7 days during week 6., Baseline (week 0) and week 6|• Difference between the two treatment arms in change in weekly time (total and nocturnal) spent with hypoglycaemia (interstitial glucose <3.0 mmol/L and <3.9 mmol/L) from baseline to week 6, measured with a continuous glucose monitor., Interstitial glucose is measured for 7 days during the baseline week (week 0) and 7 days during week 6., Baseline (week 0) and week 6|• Difference between the two treatment arms in change in weekly events (diurnal, total and nocturnal) of hypoglycaemia (interstitial glucose <3.0 mmol/L and <3.9 mmol/L) from baseline to week 6, measured with a continuous glucose monitor., Interstitial glucose is measured for 7 days during the baseline week (week 0) and 7 days during week 6., Baseline (week 0) and week 6
GDFT on the Postoperative Outcome in Head and Neck Cancer Surgery
NCT Number: NCT06468852
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Postoperative Complications
Interventions: PROCEDURE: Goal-Directed Fluid Therapy
Sponsor: Beijing Tongren Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 340
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-05-16
Completion Date: 2026-12-31
Locations: Beijing tongren Hospital, Capital Medical University, Beijing, Beijing, 100730, China

Summary:
The goal of this clinical trial is to evaluate whether goal-directed fluid therapy (GDFT) can improve the postoperative recovery in patients undergoing head and neck cancer surgery. It aims to answer is:

• Whether GDFT can reduce the occurrence of serious postoperative complications? Researchers will compare GDFT protocol to a standard conventional fluid therapy in head and neck cancer surgery to see if GDFT strategy works to improve the postoperative recovery.

Participants will

* Receive GDFT protocol or a conventional fluid therapy during the surgery.
* Be continuously follow-up during hospitalization and after discharge to record the occurrence of postoperative complications.

Primary Outcome Measures: Serious complications occurred within 30 days after surgery, Unit: %; All postoperative complications will be evaluated according the Clavien-Dino classification(CDc) of surgical complications. Each complication has an equal weight, and patients with at least one complication will be considered to have experienced postoperative complications.

The serious postoperative complications were defined as CDc≥3., within 30 days after surgery
Secondary Outcome Measures: All complications within 30 days after surgery, Unit: %;All postoperative complications will be evaluated according the Clavien-Dino classification(CDc) of surgical complications., within 30 days after surgery|The length of hospital stay after surgery, Unit: days; from date of operation till date of discharge, 1 months after operation|Cost of hospitalization, Unit: yuan; Total cost during hospitalization, 1 months after operation|Quality of Recovery Score, Unit: point; Use QoR-15 to evaluate the postoperative recovery of all patients. QoR-15 is a global measure of recovery after surgery that evaluates five dimensions of recovery: physical comfort (5 items), physical independence (2 items), emotional state (4 items), psychological support (2 items), and pain (2 items). Each item is rated on an 11- point scale based on its frequency on the questionnaire (greater score at greater frequency for positive items and less frequency for negative items). The total score ranged from 0 (poorest recovery quality) to 150 (best recovery quality)., At 1,3, and 5 days after surgery
The Impact of Addiction Management Model on Digital Addiction and Psychological Resilience in Second School Students
NCT Number: NCT06468839
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Technology Addiction, Psychological Resilience, Risky Technology Use in Adolescent
Interventions: BEHAVIORAL: digital addiction management model
Sponsor: Ankara University
Sex: ALL
Age: CHILD
Enrollment: 80
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-03-25
Completion Date: 2024-06-13
Locations: Senem Çelik Yavuz, Çankaya, Ankara, 06800, Turkey

Summary:
Digital addiction has become a prevalent concern among adolescents, particularly middle school students. This study aims to develop and evaluate an addiction management model for 6th-grade students at risk of digital addiction. The model will combine standardized psychological resilience training with emotional freedom techniques to address both the behavioral and emotional aspects of digital addiction.

Primary Outcome Measures: Assessing Digital Addiction Risk Level, The Children and Adolescents' Digital Addiction Scale (CADAS) will be employed to evaluate the digital addiction risk level of the participants.• The CADAS scale ranges from 25 to 125, with higher scores indicating a greater risk of digital addiction.

• A decrease in the scale score reflects a reduction in digital addiction risk, 1-3 month
A Study of Avacopan in Participants With Normal Renal Function and Participants With End-Stage Renal Disease (ESRD)
NCT Number: NCT06468826
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: End-Stage Renal Disease (ESRD)
Interventions: DRUG: Avacopan
Sponsor: Amgen
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 12
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-07-11
Completion Date: 2025-01-10
Locations: Floridian Clinical Research, LLC, Miami Lakes, Florida, 33016, United States|Orlando Clinical Research Center, Orlando, Florida, 32809-3017, United States

Summary:
The primary objective of the study is to evaluate the pharmacokinetics (PK) of avacopan and metabolite (M1) after a single dose of avacopan in participants with normal renal function and participants with ESRD requiring hemodialysis (HD).

Primary Outcome Measures: Maximum Observed Plasma Concentration (Cmax) of Avacopan, Predose, 0.25, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36 hours (postdose), Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 12, Day 15, and Day 18.|Cmax of M1, Predose, 0.25, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36 hours (postdose), Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 12, Day 15, and Day 18.|Area Under the Plasma Concentration-time Curve (AUC) from Time Zero to Time of Last Quantifiable Concentration (AUClast) of Avacopan, Predose, 0.25, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36 hours (postdose), Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 12, Day 15, and Day 18.|AUClast of M1, Predose, 0.25, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36 hours (postdose), Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 12, Day 15, and Day 18.|AUC from Time Zero to Infinity (AUCinf) of Avacopan, Predose, 0.25, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36 hours (postdose), Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 12, Day 15, and Day 18.|AUCinf of M1, Predose, 0.25, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36 hours (postdose), Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 12, Day 15, and Day 18.|AUC from Time Zero to 48 Hours (AUC0-48) of Avacopan, Predose, 0.25, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36 hours (postdose), Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 12, Day 15, and Day 18.|AUC0-48 of M1, Predose, 0.25, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36 hours (postdose), Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 12, Day 15, and Day 18.|HD Clearance of Drug From Plasma (CLD) of Avacopan, Predose, 0.25, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36 hours (postdose), Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 12, Day 15, and Day 18.|HD CLD of M1, Predose, 0.25, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36 hours (postdose), Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 12, Day 15, and Day 18.
Secondary Outcome Measures: Number of Participants who Experienced Treatment-emergent Adverse Events, Up to approximately 37 days.|Number of Participants who Experienced Serious Adverse Events, Up to approximately 96 days.
Kosmos Anatomical Object Labeling and View Identification Pivotal Study
NCT Number: NCT06468787
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cardiac Disorder|Hepatic Disorder|Spleen Disorder|Kidney Disorder|Pulmonary Disorder|Renal Disorder|Hepatobiliary Disorders|GYN Disorders
Interventions: DEVICE: Kosmos Anatomical Object Labeling and View Identification Algorithms
Sponsor: EchoNous Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 32
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-02-07
Completion Date: 2024-02-22
Locations: REVIVAL research institute, LLC, Sherman, Texas, 75092, United States

Summary:
This is a multi-site, multi-group study that obtained two sets of ultrasound scans from all enrolled participants. Participants underwent limited ultrasound scanning by both cardiac sonographers and abdominal sonographers. Algorithm's performance on the view identification task and the object labeling task is computed.

Primary Outcome Measures: False discovery rate of the anatomical object labeling function on expert-obtained images, The objective of this study is to compare the average frame-level disagreement of object labeling by majority opinion of five expert reviewers. The frame-level disagreement is defined as False Discovery Rate as in (1) FDR = 1-Precision=FP/(FP+TP) (1) Where TP≡True Positive and FP≡False Positive. A True Positive is counted when the majority opinion of five expert reviewers agrees with the location of predicted labels in the image. A False Positive counted when majority opinion of five expert reviewers disagrees with the location of one or more predicted labels.

False Discovery Rate (FDR) is measured for a particular image frame between predicted objects and the majority opinion of five reviewers. The frame-level FDR threshold for this prospective study is 20%. Therefore, for a successful outcome the frame-level FDR must be less than 20%., Post data acquisition (3 months)|False discovery rate of the anatomical view identification function on expert-obtained images, The objective of this study is to compare the average frame-level disagreement of object labeling by majority opinion of five expert reviewers. The frame-level disagreement is defined as False Discovery Rate as in (1) FDR = 1-Precision=FP/(FP+TP) (1) Where TP≡True Positive and FP≡False Positive. A True Positive is counted when the majority opinion of five expert reviewers agrees with the location of predicted labels in the image. A False Positive counted when majority opinion of five expert reviewers disagrees with the location of one or more predicted labels.

False Discovery Rate (FDR) is measured for a particular image frame between predicted objects and the majority opinion of five reviewers. The frame-level FDR threshold for this prospective study is 20%. Therefore, for a successful outcome the frame-level FDR must be less than 20%., Post data acquisition (3 months)
2-year Mortality After COVID-19 in Nursing Home Residents
NCT Number: NCT06468761
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Covid19
Sponsor: Bichat Hospital
Sex: ALL
Age: OLDER_ADULT
Enrollment: 315
Study Design: Observational Model: |Time Perspective: p
Start Date: 2020-05-11
Completion Date: 2022-07-26
Locations: Department of Geriatrics, Paris, 75018, France

Summary:
This was a retrospective study conducted in three Nursing Homes (NHs). Residents who had survived the 1st CoPW (March to May 2020) were included. The diagnosis of COVID-19 was based on the results of a positive reverse transcriptase-polymerase chain reaction test. The collected data also included age, sex, length of residence in the NH, disability status, legal guardianship status, nutritional status, need for texture-modified food, hospitalization or Emergency Department visits during lockdown and SARS-COV2 vaccination status during the follow-up. Non-adjusted and adjusted Cox models were used to analyse factors associated with 2-year post-1stCoPW mortality.

Primary Outcome Measures: All cause mortality, months
The Relationship Among Sarcopenia, Preperitoneal Fat Thickness and Cholecystectomy
NCT Number: NCT06468735
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Sarcopenia|Cholecystectomy
Interventions: DIAGNOSTIC_TEST: sarcopenia assessment|DIAGNOSTIC_TEST: visceral fat thickness measurement
Sponsor: Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 158
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-03-20
Completion Date: 2024-06-19
Locations: Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital, Ankara, Turkey

Summary:
The aim of this study was to examine the relationship between sarcopenia and visceral adiposity in participants with and without cholecystectomy.

In this way, the long-term effects of cholecystectomy operations, which are commonly performed in the society and thought to be harmless, will be evaluated.

Primary Outcome Measures: STAR values, \<1.0 for females and \<1.4 for males Quadriceps thickness(mm) /BMI kg/m2, through study completion, an average of 4 months|low grip strength, \<19 kg for females or \<32 kg for males, through study completion, an average of 4 months|chair stand test duration, ≥12 seconds, through study completion, an average of 4 months|visceral adipose tissue thickness, mm, through study completion, an average of 4 months|Subcutaneous maximum fat thickness, mm, through study completion, an average of 4 months|Subcutaneous minimum fat thickness, mm, through study completion, an average of 4 months|Preperitoneal fat thickness, mm, through study completion, an average of 4 months
Secondary Outcome Measures: BMI, kg/m2, through study completion, an average of 4 months|Waist circumference, cm, through study completion, an average of 4 months
Fat Oxidation Capacity in Patients With Post Covid-19 Syndrome
NCT Number: NCT06468722
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Post-COVID-19 Syndrome|Long-COVID-19 Syndrome
Interventions: BEHAVIORAL: Exercise-based rehabilitation
Sponsor: University of Witten/Herdecke
Collaborators: Institut für Rehabilitationsforschung Norderney
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 187
Study Design: Observational Model: |Time Perspective: p
Start Date: 2021-04-01
Completion Date: 2024-05-21
Locations: Clinic Königsfeld, Ennepetal, NRW, 58256, Germany

Summary:
Post-COVID-19 Syndrome (PCS) is characterized by symptoms, including fatigue, reduced physical performance, dyspnea, cognitive impairment, and psychological distress. The mechanisms underlying the onset and severity of PCS point to mitochondrial dysfunction as significant contributor. This study examined fat oxidation as a function of mitochondrial capacity during exercise.

Primary Outcome Measures: Change in Fat Oxidation Rate, Fat oxidation will be assessed by breath-by-breath spiroergometry, Baseline and week 4 (i. e. before discharge)
Secondary Outcome Measures: Change in Carbohydrate Oxidation Rate, Carbohydrate oxidation rate will be assessed by breath-by-breath spirometry, Baseline and week 4 (i. e. before discharge)|Change in Fatigue, Fatigue will be assessed using the "The Multidimensional Fatigue Inventory (MFI20)", Baseline and week 4 (i. e. before discharge)
A Trial on the Recurrence Free Survival Rate of Type I AIP With High-risk of Recurrence
NCT Number: NCT06468709
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Type 1 AIP
Interventions: DRUG: Glucocorticoids|DRUG: Glucocorticoids+MMF
Sponsor: Ruijin Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 86
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-20
Completion Date: 2027-07-31
Locations: Ruijin Hospital, Shanghai, Shanghai, 200025, China

Summary:
Autoimmune pancreatitis (AIP) is an autoimmune disease with low incidence rate and involving the pancreas. In China, type I AIP is predominant. Glucocorticoids (GC) have a significant therapeutic effect. Even though a consensus has been reached on the effective initial GC treatment dose, type I AIP is prone to recurrence after GC induction and maintenance therapy. Currently, there is no consensus on how to reduce the disease recurrence rate in high-risk type I AIP patients. Multiple studies have shown that immunosuppressants (IM) combined with GC can effectively reduce the disease recurrence rate in IgG4 RD patients, including azathioprine, mycophenolate mofetil (MMF), etc. Among them, the incidence of adverse reactions in MMF is relatively low. As a special type of IgG4-RD, there is currently no prospective study evaluating the efficacy and safety of GC combined with MMF treatment in high-risk recurrent type I AIP patients. The smooth implementation of this project can provide new treatment ideas and evidence-based medicine for reducing the recurrence rate of high-risk type I AIP.

Primary Outcome Measures: Evaluation of the impact of monotherapy with glucocorticoids and glucocorticoid combined with MMF maintenance therapy on disease remission rate in high-risk type I AIP patients for recurrence within 3 years, to evaluate the disease remission rate of monotherapy with glucocorticoids and glucocorticoid combined with MMF maintenance therapy in high-risk type I AIP patients within 3 years, 3 years
Secondary Outcome Measures: Evaluate the impact on endocrine function, to evaluate the incidence rate of diabetes mellitus, including measuring Hb1Ac, C peptide, insulin secretion., 3 years|Evaluate the impact of external secretion pancreatic function, to evaluate the incidence rate of external secretion disfunction of pancreas including the level of vitamin, 25-OH-D3, 3 years|Assess the impact on the incidence of malignant tumors, to assess the impact on the incidence of gastrointestinal tumors by endoscopies, 3 years|Adverse reactions, Adverse reactions including the allergic reactions to drugs, 3 years|Treatment costs, to assess the total treatment costs in 3 years, 3 years
Improvements in Thyroid Tumor Surgery and the Prognosis, Diagnosis, Recurrence and Metastasis of Patients
NCT Number: NCT06468696
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Papillary Thyroid Cancer|Lymph Node Metastasis|Carcinogenesis
Interventions: PROCEDURE: Suturing the cervical linea alba during endoscopic thyroid surgery.|GENETIC: Performing transcriptome sequencing
Sponsor: Second Affiliated Hospital of Xi'an Jiaotong University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 170
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-04-01
Completion Date: 2026-01-01
Locations: Xi'an Jiaotong University Second Affiliated Hospital, Xi'an, Shaanxi, 710049, China

Summary:
The objective of this research is to investigate the clinical outcomes of modified surgical techniques such as omitting the cervical linea alba suture in transthoracic endoscopic thyroidectomy. Furthermore, the study requires the collection of normal thyroid tissues, benign and malignant thyroid tumors, and lymph nodes to further clarify the mechanisms associated with the initiation, progression, metastasis, and recurrence of thyroid cancer.

Primary Outcome Measures: Postoperative neck edema Incidence rate, Postoperative neck edema Incidence rate, Within one week post-surgery|Postoperative short-term pain, Record the patient's perception of wound pain on postoperative days 1, 3, and 5 using the Numerical Rating Scale (NRS), which ranges from 0 (no pain) to 10 (worst pain), for quantification., Within one week post-surgery|Thyroid Papillary carcinoma tissue mRNA expression profile, After extracting total RNA from tissue, it is purified and a cDNA library is constructed. Following library quality control, sequencing is conducted on the Illumina NovaSeq 6000 platform using the PE150 mode to obtain tissue mRNA expression data., Within one month after the transcriptome sequencing.|Thyroid papillary carcinoma metastatic lymph node mRNA expression profile, After extracting total RNA from tissue, it is purified and a cDNA library is constructed. Following library quality control, sequencing is conducted on the Illumina NovaSeq 6000 platform using the PE150 mode to obtain tissue mRNA expression data., Within one month after the transcriptome sequencing.
F01 in the Treatment of Moderate-to-severe Refractory Systemic Lupus Erythematosus
NCT Number: NCT06468683
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Lupus Erythematosis
Interventions: BIOLOGICAL: After preconditioning with chemotherapy, F01 will be evaluated.
Sponsor: Shanghai Simnova Biotechnology Co.,Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-15
Completion Date: 2027-12-31
Locations: Shanghai jiaotong University School of Medicine,Renji Hospital, 上海市, 上海市, 200000, China

Summary:
This is a phase I clinical study to evaluate the safety , pharmacokinetic profile, and preliminary efficacy of F01 in patients with moderate-to-severe refractory systemic lupus erythematosus.

Primary Outcome Measures: Primary Outcome Measures, The proportion of subjects with AEs and SAEs, 12 weeks|Primary Outcome Measures, The proportion of subjects with DLT, 4 weeks
Secondary Outcome Measures: Secondary Outcome Measures, Efficacy of F01 cells in moderate-to-severe refractory systemic lupus erythematosus, 48 weeks|Secondary Outcome Measures, Cellular kinetics \[ Time Frame: 96 weeks\] The maximum concentration (Cmax), 96 weeks|Secondary Outcome Measures, Cellular kinetics \[ Time Frame: 96 weeks\] the time to reach the highest concentration (Tmax), 96 weeks|Secondary Outcome Measures, Cellular kinetics \[ Time Frame: 96 weeks\] the area under the curve of the drug time (AUC0-last), 96 weeks|Secondary Outcome Measures, Cellular kinetics \[ Time Frame: 96 weeks\] the last detectable concentration point (Clast), 96 weeks|Secondary Outcome Measures, Cellular kinetics \[ Time Frame: 96 weeks\] the time of the last detectable concentration (Tlast), etc., 96 weeks|Secondary Outcome Measures, Cellular kinetics \[ Time Frame: 96 weeks\] dynamic changes in cytokine levels in the subject's peripheral blood at baseline and after dosing; The number of cases, positive rate, 96 weeks|Secondary Outcome Measures, Cellular kinetics \[ Time Frame: 96 weeks\] duration of anti-CAR and IL-15 antibodies (ADA), 96 weeks
Other Outcome Measures: Exploratory, Explore the correlation between the concentration of PK and PD and efficacy and safety by CTCAE v5.0, 96 weeks|Exploratory, Explore the correlation between KIR mismatch and efficacy and safety by CTCAE v5.0, 96 weeks|Exploratory, Immunogenicity study of Cas9, 96 weeks
Short-course Radiotherapy Combined With Sintilimab for Neoadjuvant Treatment of Esophageal Squamous Cell Carcinoma
NCT Number: NCT06468670
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Esophageal Squamous Cell Carcinoma
Interventions: DRUG: sintilimab，programmed death 1 monoclonal antibody
Sponsor: Fujian Cancer Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-17
Completion Date: 2027-06

Summary:
This study is aimed to evaluate the efficacy and safety of short-course radiotherapy combined with sintilimab in neoadjuvant treatment of stage III, locally advanced esophageal squamous cell carcinoma.

Primary Outcome Measures: Pathological complete response, Total tumor regression rate under pathologyPrimary tumor or lymph node surgery specimen pathological examination without residual tumor cell, 4 weeks after surgery|Incidence rate of adverse events, The ratio of the number of cases with adverse events to the total number of cases available for evaluation., 3 years
Secondary Outcome Measures: overall survival, the time from randomization to death, 3 years|Disease-free survival, the time from treatment until the recurrence of disease (or death) after undergoing curative-intent treatment, 3 years
Evaluation of the Impact of Ejection Fraction on Clinical Outcomes in Patients Undergoing Cardiovascular Surgery
NCT Number: NCT06468657
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Cardiac Output, Low
Interventions: OTHER: mortality rates
Sponsor: Kanuni Sultan Suleyman Training and Research Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 610
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-01
Completion Date: 2025-01-02

Summary:
This study evaluates the impact of ejection fraction (EF) on clinical outcomes in patients undergoing cardiovascular surgeries, specifically coronary artery bypass grafting (CABG) and heart valve replacement. It spans surgeries performed between 2012 and 2022 at Mehmet Akif Ersoy Thoracic and Cardiovascular Surgery Training and Research Hospital. Patients are categorized into two groups based on their preoperative EF: those with preserved EF (≥50%) and those with reduced EF (\<50%).

The primary aim is to assess how EF affects postoperative morbidity, mortality, hospital stay, and complications. Secondary aims include evaluating the development of postoperative arrhythmias, the need for vasopressors and inotropes, and transfusion requirements.

Data will be collected retrospectively from hospital records and electronic health systems. The study's findings are expected to provide insights into tailored perioperative and postoperative management strategies for patients with varying EF levels, ultimately improving clinical outcomes.

Primary Outcome Measures: mortality, mortality in 30 days, 30 days
Phase II Study of Different Doses of Radiotherapy Combined With Sintilimab in the Treatment of Locally Advanced Esophageal Squamous Cell Carcinoma
NCT Number: NCT06468644
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Esophageal Squamous Cell Carcinoma
Interventions: DRUG: chemoradiotherapy （CRT）+sintilimab 1|DRUG: CRT+sintilimab 2
Sponsor: Fujian Cancer Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-17
Completion Date: 2027-06

Summary:
This study is aimed to evaluate the efficacy and safety of different doses of radiotherapy combined with sintilimab in locally advanced esophageal squamous cell carcinoma.

Primary Outcome Measures: progression free survival, the time from random assignment in a clinical trial to disease progression or death from any cause, 1 years|Incidence rate of adverse events, The ratio of the number of cases with adverse events to the total number of cases available for evaluation., 3 years
Secondary Outcome Measures: overall survival, the time from randomization to death, 3 years|Objective Response Rate, the proportion of patients with a complete response or partial response to treatment according to Response Evaluation Criteria in Solid Tumors 1.1, 3 months after therapy
Effects of Nursing Patient Handover
NCT Number: NCT06468631
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Patient Satisfaction|Nurse's Role
Interventions: BEHAVIORAL: Complex Nursing Intervention
Sponsor: Kahramanmaras Sutcu Imam University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 369
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-01-25
Completion Date: 2022-09-08
Locations: Adana city training and research hospital, Adana, Turkey

Summary:
This study was planned in a quasi-experimental design, focusing on the feasibility, evaluation, and implementation of patient handover between nurses, and the effect of interventions to increase their effectiveness on the patient's satisfaction with care, trust in the nurse, and the quality of nurses' patient handover.The main question it aims to answer is:

Does the intervention implemented in nurses' patient handover increase patients' satisfaction with care, its effect on their trust in nurses, and the quality of nurses' patient handover?

Primary Outcome Measures: Nursing handover quality, Nurses carry out written and verbal handover procedures for each patient using the standard patient handover form. Handover quality is measured by the presence of observational transferred information and the Handoff CEX Scale., 2 weeks and 8 weeks
Secondary Outcome Measures: Patient Trust in Nurses and Newcastle Nursing Care Satisfaction Scale Levels, Evaluation of patients' Trust in Nurses and Nursing Care Satisfaction after the patient handover intervention applied to nurses. The scale is a 5-point scale consisting of 24 items including nursing care. Newcastle nursing care satisfaction scale is a 5-point scale consisting of 24 items including nursing care. It is a Likert type scale. Score evaluation is made from 0 to 100 by adding the scores of all items marked on the scale and converting them to 100. It is done based on points. A total score of 100 is considered to indicate satisfaction with all aspects of nursing care. The total score of the trust in nurses scale (minimum 5 points - maximum 30 points) is measured by summing the scores of the answers given to the questions. A high score from the scale indicates a high level of trust in nurses., 2 weeks and 8 weeks
Safety, Tolerability and Efficacy of JCXH-211 in Patients With Recurrent or Progressive High-Grade Glioma
NCT Number: NCT06468605
Acronym: SERIL
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Recurrent or Progressive High-grade Glioma
Interventions: BIOLOGICAL: JCXH-211
Sponsor: Duke University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 21
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-10-01
Completion Date: 2029-10-01

Summary:
This is a phase 1 open label study to establish the safety, tolerability, maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D), and preliminary efficacy of a single dose of JCXH-211. The study agent JCXH-211, is a self-replicating RNA (srRNA)-based human IL-12, administered intratumorally via convection-enhanced delivery (CED) to patients with recurrent or progressive high-grade glioma. Primary objective is to determine MTD or RP2D for a single dose on the study drug. Secondary outcomes include overall survival (OS) and progression-free survival (PFS) as assessed by modified mRANO 2.0.

Primary Outcome Measures: MTD or RP2D, Determine Minimum Tolerated Dose (MTD) or Recommended Phase 2 Dose (RP2D) of JCXH-211 in patients with recurrent or progressive high-grade glioma, Day 1 of treatment until 28 days post first infusion
Secondary Outcome Measures: Overall Survival, Day 1 of treatment until death to calculate Median overall survival by the Kaplan-Meier method., 5 years|Progression Free Survival, Day 1 of treatment until first documentation of disease progression as assessed by modified RANO 2.0 criteria or death to calculate Median progression free survival by the Kaplan-Meier method., 5 years
Implantation in Posterior Maxilla in Cases With Insufficient Bone
NCT Number: NCT06468592
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Bone Loss in Jaw|Implant Site Reaction
Interventions: PROCEDURE: Tilted insertion of implants|PROCEDURE: Straight insertion of implants
Sponsor: Damascus University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 31
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2022-03-02
Completion Date: 2023-06-28
Locations: Orthodontics Department, Faculty of Dentistry, University of Aleppo, Aleppo, Syrian Arab Republic

Summary:
Dental implant procedures are performed on two groups of individuals who share the common characteristic of insufficient bone for traditional implantation.

The first group lacks a palatal process, while the second group has a palatal process. Then, compare the initial primary stability of implants in the maxillary bone-type (D4) that were inserted tilted in the palatal process of the maxilla, palatally from the maxillary sinus, with implants inserted axially into the maxillary sinus by using a manual torque wrench.

Primary Outcome Measures: The initial implant stability, Primary stability was recorded for all implants in both groups, estimated by Newton/cm (N/cm), using a manual torque wrench.

This manual measure consists of a fixed arm installed above the implants and a moving arm moving away from the fixed arm in a clockwise direction, graduating from 5-45 Newtons. When the moving arm stops, the distance between it and the fixed arm expresses the first degree of the initial primary stability., one time assessment at five minutes following the completion of inserting implants.
Identification of Benign and Malignant Breast Nodules Using Ultrasound-modulated Optical Tomography: A Multicenter Study
NCT Number: NCT06468566
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Breast Cancer Female
Interventions: DIAGNOSTIC_TEST: Ultrasound light scattering imaging equipment
Sponsor: Xin-Wu Cui
Collaborators: Hubei Cancer Hospital|Guangxi National Hospital|First Affiliated Hospital of Kunming Medical University
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 2000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-02-01
Completion Date: 2026-02-28
Locations: Xin-Wu Cui, Wuhan, Hubei, 430030, China

Summary:
Ultrasonic light scattering imaging is a new functional imaging technology that combines traditional B-mode ultrasound imaging and light scattering tomography (DOT). It can improve the accuracy of early diagnosis of breast cancer based on the characteristics of abnormal blood supply and oxygen consumption of lesions. This study aims to evaluate the value of ultrasonic light scattering imaging in the differential diagnosis of benign and malignant breast nodules, and to evaluate the consistency between ultrasonic light scattering imaging and examiners in the differential diagnosis of benign and malignant breast nodules.

Primary Outcome Measures: Benign breast tumor, Pathological diagnosis, Up to 12 months|Malignant breast tumor, Pathological diagnosis, Up to 12 months|Breast lymph node metastasis, Pathological diagnosis, Up to 12 months|No lymph node metastasis, Pathological diagnosis, Up to 12 months
Combination of Micropulse Laser With or Without Photodynamic Therapy for Chronic Central Serous Chorioretinopathy
NCT Number: NCT06468540
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Central Serous Chorioretinopathy|Micropulse Laser|Photodynamic Therapy
Sponsor: Beijing Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-15
Completion Date: 2025-12-15

Summary:
In this study, patients with chronic central serous chorioretinopathy who were treated by micropulse laser alone or micropulse laser combined with photodynamic therapy without drugs are retrospectively included. The visual acuity changes, subretinal fluid absorption and choroidal characteristics of the two groups are compared 1 to 6 months after treatment. We will also analyze baseline characteristics that influence post-treatment outcomes to identify potential predictors of poor treatment outcomes.

Primary Outcome Measures: BCVA, Best-corrected visual acuity using logMAR, 1 month and 6 months|CRT, Central retinal thickness on OCT, 1 month and 6 months
Secondary Outcome Measures: SFCT, subfoveal choroidal thickness on OCTA, 1 month and 6 months
SEP and the Impact of Price on Food Selection in a Simulated Food Delivery App
NCT Number: NCT06468501
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Food Selection|Healthy Eating|Eating Behavior
Interventions: BEHAVIORAL: Price reduction on healthier foods|BEHAVIORAL: Price increase to less healthy foods|BEHAVIORAL: Combination of price reduction on healthier foods and price increase on less healthy foods|BEHAVIORAL: Control
Sponsor: University of Liverpool
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 3464
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: PREVENTION
Start Date: 2024-07-01
Completion Date: 2024-07-21
Locations: University of Liverpool, Liverpool, Merseyside, L69 7ZA, United Kingdom

Summary:
The goal of this randomised controlled trial is to compare taxation with subsidies to encourage healthier food choices in the out-of-home food sector. Participants will be asked to make hypothetical food choices in an online simulation study of a delivery app. Participants will be randomised into four different intervention groups:

1. Price reduction (10%) on healthier foods
2. Price increase (10%) to less healthy foods
3. A combination of price reduction to healthier foods and price increase to less healthy foods
4. Existing price structure (i.e. control group)

The investigators will further examine effectiveness of these fiscal policies on healthy eating by socioeconomic position to understand whether these policies are equitable.

Primary Outcome Measures: Healthier vs less healthy main meals ordered based on the Nutrient Profiling Model and total energy (kcal), Healthier vs less healthy main meals ordered, immediately after food choice|Total energy (kcal) ordered, The total energy content of the total hypothetical food order, immediately after food choice
Secondary Outcome Measures: Proportion of selecting healthier vs less healthy meal items of the total food order based on the Nutrient Profiling Model and total energy (kcal), Proportion of selecting healthier vs less healthy meal items of the total hypothetical food order, immediately after food choice|Total fat, saturated fat, salt and sugar ordered, Total fat, saturated fat, salt and sugar of total hypothetical food order, immediately after food choice