pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Phase 1 Study of HRS-9231 Safety and Pharmacokinetics in Healthy Caucasians
NCT Number: NCT06519981
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: EARLY_PHASE1
Conditions: MRI
Interventions: DRUG: HRS-9231or matching placebo
Sponsor: Atridia Pty Ltd.
Sex: ALL
Age: ADULT
Enrollment: 20
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: DIAGNOSTIC
Start Date: 2024-08-21
Completion Date: 2024-10-15
Locations: Linear Clinical research, Perth, Western Australia, Australia

Summary:
This is a phase 1, randomized, double-blind, placebo-controlled study. The objective of this study is to evaluate the safety, tolerability, and PK profile of HRS-9231 injection following a single dose in healthy Caucasian participants.

Primary Outcome Measures: Adverse events, Number of patients with adverse events (AEs) and serious adverse event (SAE), Day 8|Vital signs, Number of patients with clinically significant change from baseline in vital signs values, Day 8|Physical examination, Number of patients with clinically significant change in physical examination, Day 8|Laboratory, Number of patients with clinically significant change from baseline in laboratory examination, Day 8|ECG, Number of patients with clinically significant change from baseline in 12-ECG values, Day 8|Injection site reaction, Number of patients with injection site reaction, Day 8
Secondary Outcome Measures: Pharmacokinetics PK Cmax, Plasma Pharmacokinetics: Cmax, Day 1|Pharmacokinetics PK AUC0-t, Plasma Pharmacokinetics: AUC0-t, Day 1|Pharmacokinetics PK AUC0-inf, Plasma Pharmacokinetics: AUC0-inf, Day 1|Pharmacokinetics PK Tmax, Plasma Pharmacokinetics: Tmax, Day 1|Pharmacokinetics PK t1/2, Plasma Pharmacokinetics: t1/2, Day 1|Pharmacokinetics PK CL, Plasma Pharmacokinetics: CL, Day 1|Pharmacokinetics PK Vz, Plasma Pharmacokinetics: Vz, Day 1|Pharmacokinetics PK MRTlast, Plasma Pharmacokinetics: MRTlast, Day 1|Pharmacokinetics PK MRTinf, Plasma Pharmacokinetics: MRTinf, Day 1|Pharmacokinetics PK Ae, Urine Pharmacokinetics: Ae, Day 3|Pharmacokinetics PK ur, Urine Pharmacokinetics: ur, Day 3|Pharmacokinetics PK %Ae, Urine Pharmacokinetics: %Ae, Day 3|Pharmacokinetics PK CLr, Urine Pharmacokinetics: CLr, Day 3
Can PLIA Reduce Early Post-operative Pain After PAO Surgery?
NCT Number: NCT06519955
Acronym: PILA PAO
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2|PHASE3
Conditions: Hip Dysplasia
Interventions: COMBINATION_PRODUCT: Ropivacaine, Epinephrine, Ketorolac, NaCL
Sponsor: Michael C Willey
Collaborators: Northwestern University
Sex: ALL
Age: CHILD, ADULT
Enrollment: 120
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-08
Completion Date: 2026-09

Summary:
The goal of this clinical trial is to compare different peri-incisional local infiltrative anesthesia (PLIA) methods in patients ages 13 to 50 undergoing a periacetabular osteotomy (PAO). The main questions to answer here are:

1. Does PLIA impact post-operative pain after PAO?
2. Does PLIA impact pain medication usage as measured by morphine equivalent dosing (MED) after PAO?
3. Does the timing of PLIA administration impact post-operative pain and MED after PAO? Participants will be asked to complete some surveys; demographics survey, General Self-Efficacy Scale (GSE) and the Pain Resilience Scale. All other information will be gathered from the patients medical chart.

Researchers will compare three groups. 1.) Patients who do not receive PLIA. 2.) Patients who receive PLIA after their incision is closed. 3.) Patients who receive PLIA throughout PAO.

Primary Outcome Measures: Post-operative pain after periacetabular osteotomy., Severity of pain will be measured by collection of the visual analog scale (VAS) for pain. Scale of 1-10., PACU, 24 hours post op|Pain medication usage after periacetabular osteotomy., The amount of pain medications taken will be measured using morphine equivalent dosing (MED)., PACU to end of hospital stay, an average of 3 days.|The impact of timing of PLIA administration on post-operative pain., The mean VAS pain will be compared between the different study groups. Scale of 1-10., PACU to end of hospital stay, an average of 3 days.|The impact of timing of PLIA administration on MED., The mean MED will be compared between the different study groups., PACU to end of hospital stay, an average of 3 days.
Secondary Outcome Measures: Assessment on depression (PHQ-9), A scale to measure depression will be collected to determine the impact on early post-operative pain. Scale of 0-27., Preoperative|General Self-Efficacy Scale (GSE), Scale on self-efficacy will be collected to determine the impact on early post-operative pain. Scale of 10-40, Preoperative|Pain Resilience Scale., Scale on pain resilience (grit) will be collected to determine the impact on early post-operative pain. The scale provides two scores, Behavioral Perserverance on a scale of 0-20 and Cognitive/Affective Positivity on a scale of 0-36., Preoperative
Mental Perfomance in Patients With Coeliac Disease
NCT Number: NCT06519916
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Celiac Disease in Children|Gluten Allergy
Interventions: BEHAVIORAL: Assessment of mental performance
Sponsor: University Children's Hospital Basel
Sex: ALL
Age: CHILD, ADULT
Enrollment: 444
Study Design: Observational Model: |Time Perspective: p
Start Date: 2020-07-01
Completion Date: 2021-08-01
Locations: University Children's HOspital, Basel, Switzerland

Summary:
Coeliac disease (CD) is an immune-mediated systemic disorder triggered by gluten in genetically predisposed patients. The only available treatment is a strict life long gluten-free diet (GFD), which has been linked to a reduced quality of life (QOL) and causes alterations in the gastrointestinal microbiome. Abnormal compositions of the microbiome are now recognized as factors in the pathogenesis of neuropsychological disorders via gut-brain-axis. The aim of this study was to assess the QOL and the mental performance of children and teenagers with CD and compare it to healthy controls (HC).

Methods: Children between the ages of 6 and 18 years with CD and age-and-sex-matched healthy controls (HC) filled in a questionnaire to assess QOL and performed the Flanker task, a standardized test to assess cognitive performance.

Primary Outcome Measures: Mental performance, The performance of the Flanker -Test was compared. Flanker-Test is a standardised test to assess mental performance. All participants performed this Flanker-Test (Computer Test) and afterwards the quality of life (see below ) was assessed. There was no follow-up, in this study participants with Coeliac disease and healthy controls only performed the Flanker-Test and the assessment of Quality of life (qol)and both groups were compared to each other. In other words, it is a snapshot, as the Flanker test and the quality of life survey were carried out on the same day., cross-sectional
Secondary Outcome Measures: Quality of life (qol), The outcome of qol was compared. To assess the quality of life, all participants had to fill in the questionnaire (Kidscreen-52) at the same time, than the Flanker-Test. All tests were performed within one year. Both tests were compared between the patients with Coeliac disease and the healthy control group. In other words, it is a snapshot, as the Flanker test and the quality of life survey were carried out on the same day.

For the qol, the higher the score, the higher the qol, cross-sectional
Anxiety Reduction in Type 2 Diabetes Through Breathing ExercisesPatients With Type 2 Diabetes
NCT Number: NCT06519903
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Type 2 Diabetes|Type 2 Diabetes Treated With Insulin
Interventions: BEHAVIORAL: BREATH technique
Sponsor: Goztepe Prof Dr Suleyman Yalcın City Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 65
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: OTHER
Start Date: 2022-05-01
Completion Date: 2022-12-31
Locations: SB Istanbul Goztepe Prof Dr Suleyman Yalcin City Hospital, Istanbul, Turkey

Summary:
Injection-related anxiety is a significant barrier to the management of type 2 diabetes, adversely affecting treatment adherence and glycemic control. This study investigated the effectiveness of breathing exercises in reducing anxiety during the first insulin injection.

Primary Outcome Measures: the impact of breathing exercises on anxiety levels during the first insulin injection in patients with type 2 diabetes, the evaluation of distress, Anxiety levels were determined by Subjective Units of Disturbance Scale test. The Subjective Units of Disturbance Scale (SUDS) is a self-report measure developed by Joseph Wolpe to quantify an individual's level of distress. The scale ranges from 0 to 10, where

* 0 represents no distress or disturbance.
* 10 represents the highest level of imaginable distress or disturbance., thirty minutes|the impact of breathing exercises on anxiety levels during the first insulin injection in patients with type 2 diabetes, the evaluation of current anxiety, Anxiety levels were determined by State Anxiety Inventory tests The State Anxiety Inventory is a widely used self-report questionnaire designed to assess the current state of anxiety, distinguishing it from trait anxiety (which is more about general anxiety tendencies). The total score ranges from 20 to 80, with higher scores indicating higher state anxiety levels., thirty minutes|the impact of breathing exercises on anxiety levels during the first insulin injection in patients with type 2 diabetes, the evaluation of axiety state, The Trait Anxiety Inventory is part of the State-Trait Anxiety Inventory and specifically measures trait anxiety, which refers to relatively stable individual differences in anxiety proneness and the tendency to perceive stressful situations as threatening.The total score ranges from 20 to 80, with higher scores indicating higher trait anxiety levels., thirty minutes
Fiber and Calcium Absorption in Older Men
NCT Number: NCT06519877
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Aging
Interventions: DIETARY_SUPPLEMENT: Soluble corn fiber
Sponsor: San Francisco VA Health Care System
Sex: MALE
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: OTHER
Start Date: 2024-09
Completion Date: 2029-09

Summary:
Osteoporotic fractures are a major but underrecognized problem in men. There is growing evidence that low dietary fiber intake is a modifiable risk factor for age-related bone loss in men. Preclinical and human studies in adolescents and postmenopausal women suggest that dietary fiber intake influences bone metabolism by modulating the gut microbiome to augment intestinal calcium absorption, but it is unclear through what molecular mechanism and whether dietary fiber has the same effects in older men. In this crossover intervention study, the investigators will enroll and follow 30 older male Veterans to evaluate the effects of soluble corn fiber on intestinal calcium absorption and explore the contribution of the gut microbiome.

Primary Outcome Measures: Intestinal fractional calcium absorption, Dual stable calcium isotopic tracer method, At week 4 and week 12 of study participation (at the end of each treatment phase x2)
Secondary Outcome Measures: Biochemical markers of bone turnover, Blood draw, At week 4 and week 12 of study participation (at the end of each treatment phase x2)|Calciotropic hormones, Blood draw, At week 4 and week 12 of study participation (at the end of each treatment phase x2)|Gut microbial profiling, Stool collection, At week 4 and week 12 of study participation (at the end of each treatment phase x2)|Adherence, tolerability, and acceptability, Questionnaire, Throughout study period, an average of 12 weeks
Combined Shoulder Anterior Capsule and Suprascapular Nerve Block Versus Interscalene Block in Shoulder Surgery
NCT Number: NCT06519851
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Shoulder Pain
Interventions: OTHER: suprascapular nerve block with 10 ml bupivacaine 0.25% & shoulder anterior capsule block with 30 ml bupivacaine 0.25%|OTHER: Interscalene block with 20 ml bupivacaine 0.25%
Sponsor: Assiut University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 42
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2025-12

Summary:
The study aims to evaluate the postoperative analgesic effect of combined shoulder anterior capsule (SHAC) block with suprascapular nerve block (SSNB) versus Interscalene block (ISB) during the first 24 hours following shoulder surgery.

Primary Outcome Measures: Evaluation of postoperative analgesia measured by Visual analogue scale during the first 24 hours after shoulder surgery., Visual analogue scale consists of a 10 centimeter line, with two end points representing 0 (no pain) and 10 (worst imaginable pain), Pain will be assessed at 1st hour, then at 2, 6, 12, 18 and 24 hours postoperatively using VAS score.
Secondary Outcome Measures: The first time to rescue opioid analgesia, and the total opioid consumption in the first 24 hours postoperatively, The first time to rescue opioid analgesia, and the total opioid consumption in the first 24 hours postoperatively, 24 hours postoperatively|Any Complications related to the blocks, Any Complications related to the blocks as hemodynamic changes, hoarseness of voice, Horner syndrome, vascular injury, sensory or motor side effects., 24 hours postoperatively
Effect of Pre-Warming of Local Anesthesia in Reducing Pain Perception During Injection in Children
NCT Number: NCT06519838
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Local Anesthesia|Dental Anesthesia
Interventions: OTHER: Local anesthesia solution at room temperature|OTHER: Local anesthesia solution pre-warmed to 37°C|OTHER: Local anesthesia solution pre-warmed to 40°C|OTHER: Maxillary infiltration technique|OTHER: Inferior alveolar nerve block technique
Sponsor: Andrew Emad
Sex: ALL
Age: CHILD
Enrollment: 72
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-01-01
Completion Date: 2024-06-10
Locations: Faculty of Dentistry, Alexandria University, Alexandria, Egypt

Summary:
The aim of the current study was to evaluate the pain perception upon injection of pre-warmed dental anesthetic solution (at 370C and 400C) versus that at room temperature (Average 23 degrees) during Maxillary Infiltration and Mandibular Inferior Alveolar Nerve Block techniques in children

Primary Outcome Measures: Heart rate (HR) monitoring, A pulse oximeter will be used to record and measure the patient's heart rate. A baseline reading will be obtained before the LA administration and another reading will be obtained directly after the injection is carried out. Heart rate ranging between 70-100 is considered normal., during local anesthesia administration|Pain during injection using Sound, Eye, Motor (SEM) Scale, Sound, Eye, Motor (SEM) Scale was used as an objective mean to assess pain during local anesthesia administration. It comprises the following parameters:

* Sound
* Eye
* Bodily movements The slightest changes in the sound, eye movement and bodily movement of the patient will be categorized as one of the following levels; comfortable, mild, moderate, and severe discomfort and hence given a grade of 1, 2, 3 or 4 respectively. The final SEM score will be calculated by adding the grades of the three parameters., during local anesthesia administration|Pain during injection using Face scale, To assess pain subjectively during local anesthesia administration, a modified face scale. It consists of three schematic faces with different facial expressions for happy and sad faces representing:

1. Satisfaction
2. Indifference
3. Dissatisfaction Each patient was trained on using the scale by modelling and then requesting from every patient to think of the last time she/he went through a painful experience and to choose the facial expression that best relates his/her current experience of discomfort to the previous one, during local anesthesia administration
Endoscopic Combined Intrarenal Surgery vs. Percutaneous Nephrolithotomy for Treatment of Staghorn Calculi
NCT Number: NCT06519812
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Urinary Calculi
Interventions: PROCEDURE: Combined Intrarenal Surgery and percutaneous nephrolithotomy
Sponsor: Al-Azhar University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-07-01
Completion Date: 2025-06-30
Locations: Al-Azhar University Hospital (New Damietta), Damietta, 952567, Egypt

Summary:
This is a prospective randomized study to compare endoscopic combined intrarenal surgery and PCNL as modalities of treatment for staghorn stones. In terms of efficacy and safety

Primary Outcome Measures: stone-free rate, Stone-free is defined as no residual stones on CT-UT or clinically insignificant residual fragments (CIRF) less than 4 mm in diameter.

It will be measured twice, first immediately postoperatively, and then again after 3 months of the procedure., 3 months postoperative
Secondary Outcome Measures: Safety of the procedure, Intra and post-operative complications, intraoperative, early (in the first day postoperative) and late complications (3 months after the surgery).
Safety and Efficacy of Metformin for Treatment of Cytopenia in Children and Adolescents With Fanconi Anemia
NCT Number: NCT06519786
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Fanconi Anemia
Interventions: DRUG: Metformin
Sponsor: Ain Shams University
Sex: ALL
Age: CHILD, ADULT
Enrollment: 30
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2022-10-05
Completion Date: 2025-03
Locations: University of Alexandria, Alexandria, Egypt|Ain Shams University, Cairo, 11566, Egypt

Summary:
Prospective interventional open-label non-randomized controlled trial to assess safety and efficacy of metformin in treating cytopenia in children and adolescents with Fanconi Anemia.

Primary Outcome Measures: Hematologic response (erythroid), Erythroid response (pretreatment, \< 11 g/dL): Hgb increase by \> 1.5 g/dL or Relevant reduction of units of RBC transfusions by an absolute number of at least 4 RBC transfusions/8 wk compared with the pretreatment transfusion number in the previous 8 wk., 24 weeks|Hematologic response (platelets), Platelet response (pretreatment, \< 100x10e9/L): Absolute increase of \> 30 x 10e9/L for patients starting with \> 20 x 10e9/L platelets or Increase from \< 20 x 10e9/L to \> 20 x10e9/L and by at least 100%, 24 weeks|Hematologic response (Neutrophil count), Neutrophil response (pretreatment, \< 1.0 x 10e9/L): At least 100% increase and an absolute increase \> 0.5 x 10e9/L, 24 weeks
68Ga-C1 PET/ CT Imaging in Clear Cell Renal Cell Carcinoma
NCT Number: NCT06519760
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Carbonic Anhydrase IX|PET-CT|Clear Cell Renal Cell Carcinoma
Interventions: DRUG: 68Ga-C1
Sponsor: Peking University First Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-08
Completion Date: 2026-12-31
Locations: Peking University First Hospital, Beijing, Beijing, 100034, China

Summary:
The goal of this clinical trial is to evaluate the diagnostic value of CAIX protein specific probe 68Ga-C1 in PET/CT imaging in clear cell renal cell carcinoma patients. It will also learn about the safety, tolerability and radiation dosimetry of 68Ga-C1.

Researchers will compare the diagnostic value of 68Ga-C1 PET/CT and 18F-FDG PET/CT in Chinese patients with indeterminate renal masses or confirmed clear cell renal cell carcinoma.

Primary Outcome Measures: The diagnostic efficacy of 68Ga-C1 PET/CT in the evaluation of clear cell renal cell carcinoma, Compare the standardized Uptake Value (SUV) of lesions on 68Ga-C1 and 18F-FDG PET/CT, 1 year|The diagnostic efficacy of 68Ga-C1 PET/CT in the evaluation of malignant tumors, Compare the number of lesions detected by 68Ga-C1 and 18F-FDG PET/CT, based on the pathology or clinical follow-up as gold standard., 1 year
Secondary Outcome Measures: The dosimetry of 68Ga-C1, Research on the dose distribution of 68Ga-C1 in healthy volunteers and cancer patients by 1-hour dynamic PET/CT acquisition and analyze by the dosimetry software, 1 year|Quantitative evaluation of 68Ga-C1, Evaluation of quantitative parameters of 68Ga-C1, such as time-activity curve., 1 year|Correlation with pathological expression, Analyze CAIX expression at the imaging level in combination with CAIX expression in pathological specimens, 1 year
DETECTion of PeriOperative Atrial Fibrillation After Noncardiac Surgery
NCT Number: NCT06519747
Acronym: DETECT-POAF
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Atrial Fibrillation|Atrial Flutter
Interventions: DEVICE: Cardiac monitoring device
Sponsor: Population Health Research Institute
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 750
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-15
Completion Date: 2026-12-31
Locations: Hamilton General Hospital, Hamilton, Ontario, L8L 2X2, Canada|St. Joseph's Healthcare Hamilton, Hamilton, Ontario, L8N 4A6, Canada|Juravinski Hospital, Hamilton, Ontario, L8V 1C3, Canada|London Health Sciences Centre - University Hospital, London, Ontario, N6A 5A5, Canada|Niagara Health System - St. Catharine's Site, St. Catharines, Ontario, L2S 0A9, Canada|Centre Hospitalier de l'Université de Montréal, Montréal, Quebec, H2X 3E4, Canada|Hôpital Fleurimont du Centre hospitalier universitaire de Sherbrooke, Sherbrooke, Quebec, J1H 5H3, Canada

Summary:
This is a multicentre prospective cohort study where patients will receive up to 14 days of continuous ECG monitoring by wearing a portable monitoring device, starting within 72 hours after noncardiac surgery.

Primary Outcome Measures: Incidence of clinically important post-operative atrial fibrillation/atrial flutter, The primary outcome is clinically important POAF, defined as:

1. Atrial fibrillation (AF) documented by a 12-lead ECG;
2. Confirmed AF (e.g., rhythm strip) that results in symptoms of angina, heart failure, or symptomatic hypotension;
3. Confirmed AF that requires treatment with a rate controlling drug, antiarrhythmic drug, or electrical cardioversion; or,
4. Confirmed continuous AF episode with a minimum duration of 1 hour., Within 35 days of non-cardiac surgery
Secondary Outcome Measures: Incidence of sustained ventricular arrhythmia, Within 35 days of non-cardiac surgery|Incidence of sinus node dysfunction, Within 35 days of non-cardiac surgery|Incidence of high-grade atrioventricular block, Within 35 days of non-cardiac surgery|Incidence of death, Within 35 days of non-cardiac surgery|Incidence of clinically important post-operative atrial fibrillation/atrial flutter, Within 14 days of continuous cardiac monitoring|Incidence of clinically important post-operative atrial fibrillation/atrial flutter detected by clinical monitoring only, Within 35 days of non-cardiac surgery|Incidence of clinically important post-operative atrial fibrillation/atrial flutter define with minimum duration of 6 minutes, Within 35 days of non-cardiac surgery|Incidence of clinically important post-operative atrial fibrillation/atrial flutter detected by study device monitoring only, Within 35 days of non-cardiac surgery|Proportion of participants meeting eligibility criteria for ASPIRE-AF study, Within 35 days of non-cardiac surgery|Multivariate odds ratio of risk factors associated with the occurrence of clinically important POAF, A multivariate logistic regression analysis of age, sex, surgical urgency, type of surgery, vascular disease, chronic kidney disease, and heart failure., Within 35 days of non-cardiac surgery
Primitive Immunodeficiency, Intrauterine Devices and Menstrual Hygiene Products
NCT Number: NCT06519734
Acronym: FEMIDIP
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Primary Immune Deficiency Diseases
Interventions: OTHER: Questionnaire
Sponsor: Assistance Publique - Hôpitaux de Paris
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09
Completion Date: 2025-03
Locations: Hôpital Necker-Enfants Malades, Paris, 75015, France

Summary:
Primary immune deficiency diseases (PIDDs) constitute a large group of genetic disorders of the immune system which associates to varying degrees an increased susceptibility to infections and immuno-pathological manifestations: allergy, inflammation, autoimmunity, lymphoproliferation, malignancy.

Although their prevalence remains underestimated, there has been an increase in cases diagnosed in the last 10 years. The national average prevalence is 8.6 patients per 100,000 inhabitants with an incidence of 400 new cases per year in France. Life expectancy varies depending on the type of deficiency, and its impact in terms of infectious complications or malignancy.

With therapeutic progress, life expectancy increases, and more patients are concerned by contraception and menstrual hygiene. Due to the lack of data and for fear of an infectious complication, the use of intrauterine devices (IUD) and tampons or menstrual cups is traditionally advised against in patients with PID.

The objective of the research is to study the contraception methods and menstrual hygiene products used by patients with primary immunodeficiency and to evaluate related infectious complications.

The contraceptive methods of these patients, the occurrence of upper genital infections associated with the use of an intrauterine device, the severity and the evolution of these infections will be evaluated. A possible refusal to insert an intrauterine device by a healthcare professional due to primary immunodeficiency will also be studied.

Likewise, the types of menstrual hygiene products used will be studied - napkins, menstrual cups, tampons, menstrual panties -, as well as the possible occurrence of associated infectious complications - in particular menstrual toxic shock syndrome, and the treatment, severity and evolution of these complications.

Primary Outcome Measures: Occurrence of infectious complications associated with the use of intrauterine devices and tampons or menstrual cups in patients with primary immunodeficiency, Occurrence of an infectious complication - upper genital infection or menstrual toxic shock - associated with the use of an intrauterine device, tampon or menstrual cup in patients with primary immunodeficiency.

These complications will be declared by patients via the study questionnaire and then confirmed by consultation of the medical file., Time 0
Secondary Outcome Measures: Frequency of use of intrauterine devices, menstrual cups and tampons in patients with primary immunodeficiency, Frequency of use of intrauterine devices, menstrual cups or tampons reported by patients on the study questionnaire., Time 0
Safety and Efficacy Study of Lenvatinib Combined With VIC-1911 for the Treatment of Advanced HCC
NCT Number: NCT06519721
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Hepatocellular Carcinoma
Interventions: DRUG: Lenvatinib Combined with VIC-1911
Sponsor: RenJi Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 15
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2026-07-31
Locations: Deparment of Liver Surgery, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, 200127, China

Summary:
This study is a single-arm, open-label trial to clarify the safety and efficacy of the combined treatment of lenvatinib and VIC-1911 in patients with advanced liver cancer.

Primary Outcome Measures: Objective Response Rate (ORR), Objective Response Rate (ORR) is defined as the proportion of patients experiencing a complete or partial response to a treatment, 2 years
Secondary Outcome Measures: Progression-Free Survival (PFS), Progression-Free Survival (PFS) is defined as the length of time during a study that a patient with a known cancer diagnosis does not experience disease worsening or death due to the disease., 2 years|Overall Survival (OS), Overall Survival (OS) is defined as the percentage of patients in a study or a group of patients who are alive for a certain period of time after the start of treatment., 2 years
Analgesic Efficacy of Erector Spinae Plane Block vs External Oblique Intercostal Plane Block in Subcostal Cancer Surgeries
NCT Number: NCT06519708
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Analgesia|Erector Spinae Plane Block|External Oblique Intercostal Plane Block|Subcostal Cancer Surgeries
Interventions: DRUG: Erector Spinae Plane Block|DRUG: External Oblique Intercostal Plane Block
Sponsor: National Cancer Institute, Egypt
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 70
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: PREVENTION
Start Date: 2024-07-25
Completion Date: 2025-05-27
Locations: Cairo University, Cairo, 11796, Egypt

Summary:
This study aims to evaluate the impact of ultrasound-guided erector spinae plane block compared to ultrasound-guided external oblique intercostal plane block regarding management of postoperative acute pain in patients undergoing above Umbilical surgical procedure.

Primary Outcome Measures: Total amount of morphine consumption, Rescue analgesia will be provided in the form of IV morphine 3 mg boluses if the patient indicates Numeric Pain Rating Scale ≥ 4. The total amount of morphine given in 24 hours will be recorded for the two groups. A maximum dose of 0.5 mg/kg/24hours of morphine is allowed., 24 hours postoperatively
Secondary Outcome Measures: Total amount of intraoperative fentanyl consumption, Rescue analgesia of fentanyl 1 μg/kg will be given if the mean arterial blood pressure or heart rate rises above 20% of baseline levels., Intraoperatively|Heart rate, Heart rate will be recorded intraoperatively at 5-minute intervals till the end of surgery and the average of each three successive readings., Till the end of surgery|Mean arterial blood pressure, Mean arterial blood pressure will be recorded intraoperatively at 5-minute intervals till the end of surgery and the average of each three successive readings., Till the end of surgery|Time of first rescue analgesia, Time of first rescue analgesia will be recorded from the end of surgery to first dose of morphine administrated. Rescue analgesia will be provided in the form of IV morphine 3 mg boluses if the patient indicates Numeric Pain Rating Scale ≥ 4., 24 hours postoperatively|Complications, Complications related to blocks (local anesthetic systemic toxicity, pneumothorax and arterial puncture) and Morphine related complications (respiratory depression, urine retention or pruritis) will be recorded., 24 hours postoperatively|Patient satisfaction, Degree of patient satisfaction will be assessed on a 5-point Likert scale patient satisfaction (1, extremely dissatisfied; 2, unsatisfied; 3, neutral; 4, satisfied; 5, extremely satisfied)., 24 hours postoperatively
Exercise Intervention for Pre-frail Elderly
NCT Number: NCT06519695
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Older Adults
Interventions: BEHAVIORAL: Multicomponent exercises
Sponsor: Hangzhou Normal University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 144
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2022-07-01
Completion Date: 2024-12-31
Locations: Hangzhou Normal University, Hangzhou, Zhejiang, 311121, China

Summary:
The aim of this study is to evaluate the effectiveness of multicomponet exercise for reversing pre-frailty among Chinese community-dwelling pre-frail older adults.Meanwhile,to explore the effects of multicomponent exercise on self-efficiency of exercise.

Primary Outcome Measures: Reversal of pre-frailty, Reversal rate of pre-frailty (from pre-frail to robust in this study), 24 weeks
Secondary Outcome Measures: Self-efficacy for exercise, The Self-Efficacy for Exercise Scale was designed to test people's confidence to continue exercising despite barriers to exercise. The score of each item ranged from 0 to 10, with higher scores representing greater exercise self-efficacy., 24 weeks
A Pilot Study Investigating Upfront Adaptive Immunotherapy Approach in Children, Adolescent and Young Adult (CAYA) Patients With Replication-Repair Deficient (RRD) High-Grade Gliomas (HGG)
NCT Number: NCT06519682
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: High Grade Glioma|Replication Repair Deficient
Interventions: DRUG: Nivolumab|RADIATION: Radiation
Sponsor: Daniel Morgenstern
Sex: ALL
Age: CHILD, ADULT
Enrollment: 20
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2029-08

Summary:
This is open label, multicentre, single arm, pilot study of upfront nivolumab in patients with RRD-glioblastoma with favorable immune/genomic biomarkers. The purpose of the study is to use upfront immune checkpoint inhibitor (ICI) to delay/avoid radiation for patients with RRD-glioblastoma with favorable clinical (Gross total resection (GTR) or near total resection (NTR)) and biological (RRD, hypermutation, immune activation) biomarkers. At progression, patients will be undergoing surgery/biopsy and will get a combination of radiation + ICI followed by maintenance ICI. This model will allow us to additionally study the evolution tumor in response to ICI. The study will have two domains.

Primary Outcome Measures: To evaluate Radiation-free survival (RFS) from start of immunotherapy, Radiation-free survival defined as time from start of immunotherapy to date of onset of radiation for progression/recurrence as determined by the iRANO criteria., 2 years
Secondary Outcome Measures: To evaluate overall survival (OS), Defined as the time from date of enrollment until death from any cause., 5 years|To evaluate progression free survival (post first progression), Defined as time from first progression (post upfront ICI) to second progression as determined by the iRANO criteria., 2 years|To evaluate clinical benefit rate (CBR), The proportion of patients who have no evidence of progression for at least two protocol reassessment periods as determined by the iRANO criteria., 2 years|Quality of life as measured by a validated PedsQL, generic module and PROMIS., Patients and/or caregivers will complete questionnaires during regular clinic visits at three required time points: time of study enrollment, 12 weeks of therapy, end of study., 2 years
Autologous Tumor-Infiltrating Lymphocyte Injection(GT201) for Treatment of Patients With Advanced Lung Cancer
NCT Number: NCT06519669
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Adult|Lung Cancer
Interventions: BIOLOGICAL: GT201 injection
Sponsor: Grit Biotechnology
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 16
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-18
Completion Date: 2027-07-18
Locations: Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, Shanghai, 200127, China

Summary:
This study is a single arm, open design aimed at evaluating the safety and tolerability of Autologous Tumor-Infiltrating Lymphocyte (GT201 injection ) for treatment of patients with Advanced lung cancer,while evaluating pharmacokinetic characteristics and efficacy assessment.

Primary Outcome Measures: Objective response rate, To evaluate efficacy parameters such Objective Response Rate (ORR) per RECIST 1.1, as assessed by the Investigator, 3 years
Efficacy of Mazdutide for Treating PCOS
NCT Number: NCT06519656
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Polycystic Ovary Syndrome
Interventions: DRUG: Mazdutide
Sponsor: Shanghai Zhongshan Hospital
Sex: FEMALE
Age: ADULT
Enrollment: 50
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-20
Completion Date: 2026-06-30
Locations: Zhongshan Hospital Fudan University, Shanghai, 200032, China

Summary:
The goal of this clinical trial is to learn the efficacy of Mazdutide in treating obese female adults diagnosed with polycystic ovary syndrome (PCOS). The main question it aims to answer is: Does Mazdutide lower the free androgen index (FAI) in obese female adults with PCOS? Participants will take Mazdutide once every week for 24 weeks and visit the clinic once every 4 weeks for checkups and tests.

Primary Outcome Measures: Free Androgen Index (FAI), FAI=total testosterone (nmol/L)/ sex hormone binding globulin (nmol/L) X 100, 24 weeks
Secondary Outcome Measures: Times of regular menses, Record of vaginal bleeding within 24 weeks after using Mazdutide, 24 weeks|Number of immature follicles, Total number of follicles measuring 2-9 mm in diameter on ultrasound, 24 weeks|Bilateral ovary volume, Total ovary volume is calculated based on length, width and height of bilateral ovaries measured by ultrasound, 24 weeks|Serum anti-Mullerian hormone (AMH), Measurement of serum AMH, 24 weeks|HOMA insulin resistance index (HOMA-IR), HOMA-IR=fasting plasma glucose (mmol/L)×fasting insulin (μU/mlINS)/22.5, 24 weeks|HbA1c, Measurement of HbA1c, 24 weeks|body mass index (BMI), BMI = weight / height² (weight in kilograms and height in meters), 24 weeks
Building Your Successful Nursing Career
NCT Number: NCT06519643
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Nurse's Role|Gender|Professional Burnout
Interventions: BEHAVIORAL: career planning application
Sponsor: Chang Gung Memorial Hospital
Collaborators: Chang Gung University
Sex: MALE
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 120
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2027-08-05

Summary:
This study aims to evaluate a career planning mobile App specifically tailored for male nurses.This three-year experimental project aims to recruit 120 male nurses (60）in the experimental group and 60 in the control group). Employing a prospective double-blind randomized controlled trial (RCT) design, the study will include six follow-up points (pre-intervention, post-intervention at 0, 6, 12, 18, and 24 months) to examine the effectiveness of career self-efficacy, career adaptive behaviors, occupational resilience, career success, and career continuity intentions of male nurses over time. The repeated measures data will be analyzed with the intention-to-treat analysis method and General Estimating Equations (GEE). This research represents an innovative development of the world's first theoretically grounded career planning mobile App for male nurses.The study's results can serve as a valuable reference for future career planning initiatives in nursing practice and education.

Primary Outcome Measures: career self-efficacy, career self-efficacy will be collected by online structure questionnaire, before intervention and 0, 6, 12, 18, and 24 months post-intervention|career adaptive behaviors, career adaptive behavior will be collected by online structure questionnaire, before intervention and 0, 6, 12, 18, and 24 months post-intervention|occupational resilience, occupational resilience will be collected by online structure questionnaire, before intervention and 0, 6, 12, 18, and 24 months post-intervention|career success, career success will be collected by online structure questionnaire, before intervention and 0, 6, 12, 18, and 24 months post-intervention|career continuity intentions, career continuity intentions will be collected by online structure questionnaire, before intervention and 0, 6, 12, 18, and 24 months post-intervention
Study on Optimization and Evaluation of Integrated Chinese and Western Medicine for pSS Glandular Damage
NCT Number: NCT06519617
Status: ENROLLING_BY_INVITATION
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Primary Sjögren Syndrome
Interventions: DRUG: Yi Qi Yang Yin Decoction|DRUG: Hydroxychloroquine Sulfate
Sponsor: Qingwen Tao
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 136
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-13
Completion Date: 2026-12-31
Locations: China-Japan friendship hospital, Beijing, Beijing, 100029, China

Summary:
ChatGPT In a randomized controlled trial, 136 patients with primary Sjögren's syndrome (pSS) meeting the inclusion criteria were enrolled and randomly divided into two groups of 68 each. The treatment group received an optimized program combining Chinese and Western medicine for pSS glandular injury, while the control group received a conventional program for pSS glandular damage. The primary efficacy endpoint was the 12-week non-stimulated salivary flow rate (UWS) score. Secondary efficacy endpoints included the glandular damage Visual Analog Scale (VAS) scores, the European Sjögren's Syndrome Patient Reported Index (ESSPRI), among others. The treatment course lasted 12 weeks. The efficacy and safety of the optimized program for pSS glandular injury were evaluated by comparing within and between groups before and after treatment.

Primary Outcome Measures: UWS score, unstimulated flow rate of saliva score. it is positive if the UWS ≤1.5 ml/15 min（or 0.1 ml/min). Higher scores(ml/min) mean a better outcome., 12 weeks after treatment
Secondary Outcome Measures: VAS score, the glandular damage Visual Analog Scale score(dryness, fatigue and pain in the limbs). Patient self-assessed VAS scores ranged from 0 to 10. Higher scores mean a worse outcome., 12 weeks after treatment|ESSPRI, the European Sjögren's Syndrome Patient Reported Index, average of dryness, fatigue and pain in the limbs VAS scores. ESSPRI score varies from 0 to 10. Higher scores mean a worse outcome., 12 weeks after treatment|Schirmer test, Lacrimal secretion test. it is positive if the UWS ≤5 mm/5 min（or 1 mm/min). Higher scores(mm/min) mean a better outcome., 12 weeks after treatment
Open, Randomized Crossover Study on PK, PD, Biopotency, and Bioavailability of Insulin Capsules in Healthy Chinese Males
NCT Number: NCT06519604
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Diabete Mellitus
Interventions: DRUG: Human insulin enteric coated capsules in dose 16mg|DRUG: Human insulin enteric coated capsules in dose 8mg|DRUG: Human Insulin Injection in dose 5IU
Sponsor: Shanghai Jiao Tong University School of Medicine
Sex: MALE
Age: ADULT
Enrollment: 20
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-22
Completion Date: 2024-12-31

Summary:
Pharmacokinetics and pharmacodynamics study of 3 formulations (human insulin enteric coated capsules 8mg vers. human insulin injection 5IU；human insulin enteric coated capsules 16mg vers. Human Insulin Injection 5IU) Relative biopotency and bioavailability of human insulin enteric coated capsules 8mg/16mg vers. human insulin injection 5IU

Primary Outcome Measures: GIRmax, PD endpoint: The maximum glucose infusion rate, 0 -11 hours (hyperinsulinemic euglycemic clamp)|TGIRmax, PD endpoint: The time to maximum observed glucose infusion rate, 0 -11 hours (hyperinsulinemic euglycemic clamp)|AUCGIR.0-11h, PD endpoint: The area under the glucose infusion rate curve from 0 to 11 hours, 0 -11 hours (hyperinsulinemic euglycemic clamp)|AUCGIR0-∞, PD endpoint: The area under the glucose infusion rate curve from 0 to infinity, 0 -11 hours (hyperinsulinemic euglycemic clamp)
Secondary Outcome Measures: Cmax, PK endpoint: The maximum observed insulin concentration, 0 -11 hours (hyperinsulinemic euglycemic clamp)|Tmax, PK endpoint: The time to maximum observed insulin concentration, 0 -11 hours (hyperinsulinemic euglycemic clamp)|AUCIns0-11h, PK endpoint: The area under the insulin concentration curve from 0 to 11 hours, 0 -11 hours (hyperinsulinemic euglycemic clamp)|AUCIns0-∞, PK endpoint: The area under the insulin concentration-time curve from 0 hours to infinity, 0 -11 hours (hyperinsulinemic euglycemic clamp)
Other Outcome Measures: Relative biopotency, (AUCGIR of capsule:dosage)/(AUCGIR of injection:dosage), 0-11 hours (hyperinsulinemic euglycemic clamp)|Relative bioavailability, (AUCins of capsule:dosage)/(AUCins of injection:dosage), 0-11 hours (hyperinsulinemic euglycemic clamp)|Number of participants with treatment-related adverse events as assessed by CTCAE v5.0, Up to Day 14
Systemic Application of Cadonilimab, LM-302, and S-1 Combined With Intraperitoneal Infusion of Paclitaxel for the Treatment of Claudin 18.2-positive Gastric Cancer With Peritoneal Metastasis
NCT Number: NCT06519591
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Gastric Cancer Stage IV|Peritoneal Metastases
Interventions: DRUG: Cadonilimab, LM-302, S-1, paclitaxel
Sponsor: Ruijin Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07
Completion Date: 2026-06
Locations: Ruijin Hospital Shanghai Jiao Tong University School of Medicine, Shanghai, Huangpu District, 200025, China

Summary:
In this phase 2 study, we combined Cadonilimab, LM-302, and S-1 combined with intraperitoneal infusion of paclitaxel as regimen to treat gastric cancer patients with peritoneal metastasis.

Primary Outcome Measures: 1-year survival rate, 12 months
Secondary Outcome Measures: treatment related adverse events, 24 months|3-year overall survival (OS), 36 months|3-year progressive free survival (PFS), 36 months