pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
An Exploratory Study to Investigate the Effect of FE 999302 When Given Together With Follitropin Delta at Different Time Intervals During Controlled Ovarian Stimulation.
NCT Number: NCT06511791
Acronym: Celestial-2
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Infertility
Interventions: DRUG: FE 999302|DRUG: Follitropin delta|DRUG: Placebo FE 999302
Sponsor: Ferring Pharmaceuticals
Sex: FEMALE
Age: ADULT
Enrollment: 200
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, CARE_PROVIDER)|Primary Purpose: TREATMENT
Start Date: 2024-07-15
Completion Date: 2026-05-04
Locations: Ferring Investigational Site, Prague, 16000, Czechia|Ferring Investigational Site, Sevilla, 41092, Spain|Ferring Investigational Site, Valencia, 46015, Spain

Summary:
This is a phase 1b clinical trial with Choriogonadotropin beta (FE999302) and Follitropin delta (Rekovelle). The trial is a randomised, double blind, placebo controlled, parallel group, exploratory trial, investigating the effect of FE 999302 when administered during different time intervals in women undergoing controlled ovarian stimulation with a fixed dose of follitropin delta in a antagonist protocol.

Primary Outcome Measures: Number of good-quality blastocysts, Number of good-quality blastocysts on day 5 after oocyte retrieval, Day 5
Secondary Outcome Measures: Number and Size of Follicles, Number of follicles by size category on stimulation day 5 and at end-of-stimulation, Day 5 and up to 20 days|Serum hormone concentrations, Serum hormone concentrations of progesterone, androstenedione, estradiol, inhibin B, and luteinising hormone (LH)., Day 5, up to 20 days, and up to 22 days|Number of Stimulation Days, Number of stimulation days, Up to 20 days|Number of Oocytes, Number of oocytes retrieved, Up to 22 days|Number of metaphase II oocytes, Number of metaphase II (MII) oocytes, Up to 22 days|Number of fertilised oocytes, Number of fertilised (2 pronuclei \[2PN\]) oocytes, Up to 22 days|Number of blastocysts, Number of blastocysts, Up to 27 days|Number of cryopreserved blastocysts, Number of cryopreserved blastocysts, Up to 28 days|Endometrial thickness, Endometrial thickness, Up to 20 days and up to 27 days|Positive βhCG, Positive βhCG, 13-15 days after fresh transfer|Clinical pregnancy, Clinical pregnancy measured by at least one gestational sac 5-6 weeks after fresh transfer, 5-6 weeks after fresh transfer|Vital pregnancy, Vital pregnancy measured by at least one intrauterine gestational sac with fetal heart beat 5-6 weeks after fresh transfer, 5-6 weeks after fresh transfer|Ongoing pregnancy, Ongoing pregnancy measured by at least one intrauterine viable fetus 10-11 weeks after fresh transfer, 10-11 weeks after fresh transfer
sTErnAl heMostasiS Trial
NCT Number: NCT06511778
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Excessive Bleeding During Surgery
Interventions: DRUG: Hemoblast Bellows application
Sponsor: WakeMed Health and Hospitals
Collaborators: Dilon Technologies
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: PREVENTION
Start Date: 2024-08
Completion Date: 2025-09
Locations: WakeMed Health and Hospitals, Raleigh, North Carolina, 27610, United States

Summary:
Sternal bleeding remains an unsolved problem for cardiac surgery teams costing operative time, blood loss, and distraction from the critical operative field. As such, the following is an investigator-initiated trial to determine whether application of a topical hemostatic agent reduces sternal bleeding during cardiac surgery using sternotomy approach.

Primary Outcome Measures: Sternal Bleeding Score, A sternal bleeding score will be performed independently by surgeon and physician assistant utilizing the SPOT GRADE bleeding scale ranging from 0-5. 0 (no bleeding), 1 (minimal bleeding), 2 (mild bleeding), 3 (moderate bleeding), 4 (severe bleeding), 5 (extreme bleeding) before and after hemostatic agent application, Sternotomy creation|Sternal Bleeding Score, A sternal bleeding score will be performed independently by surgeon and physician assistant utilizing the SPOT GRADE bleeding scale ranging from 0-5. 0 (no bleeding), 1 (minimal bleeding), 2 (mild bleeding), 3 (moderate bleeding), 4 (severe bleeding), 5 (extreme bleeding), Sternal closure|Reoperation for Bleeding, Patients will be monitored for incidences of reoperation due to bleeding, Through hospitalization, average of 6 days|Chest Tube Output, The patient's chest tube output will be recorded after surgery, 6 hours postoperatively
Secondary Outcome Measures: Chest Tube Output, The patient's chest tube output will be recorded after surgery, 12 and 24 hours postoperatively
Induction Chemotherapy Plus Cadonilimab for Locally Advanced Cervical Cancer
NCT Number: NCT06511726
Acronym: CATPCC-01
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Cervical Cancer
Interventions: DRUG: Cadonilimab
Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 29
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-01-23
Completion Date: 2027-10-30
Locations: Sun Yat-sen Memorial hosipital, Guangzhou, Guangdong, 510000, China

Summary:
This is a Phase II clinical study for patients with locally advanced cervical cancer, aimed at evaluating the efficacy, safety, and tolerability of Cadonilimab combined with chemotherapy induction therapy, as well as exploring the correlation between the expression level of PD-L1 in tumor samples, changes in blood and tumor-local immune-related factors and cells during treatment, and the efficacy of Cadonilimab induction therapy. The study is divided into two stages, with the first stage requiring the enrollment of 9 patients. If the number of effective cases is ≤7, the trial will be terminated; if \>7 cases, it will proceed to the second stage, continuing to enroll patients until reaching 29. The Cadonilimab dosing regimen involves immunotherapy combined with chemotherapy induction, Cadonilimab and cisplatin and albumin-bound paclitaxel, for a total of 2 cycles. The radiotherapy and chemotherapy regimen includes cisplatin 30-40 mg/m2, once weekly for 5 times, external radiation (6MV-X-ray) at a dose of 45-60Gy/25F; and brachytherapy at a dose of 30Gy/5F. The primary endpoint of the study is ORR, with secondary endpoints being OS, PFS, and DCR.

Primary Outcome Measures: ORR, Objective response rate represents the proportion of patients showing a predefined level of tumor shrinkage or disappearance in response to treatment., up to18 months
Secondary Outcome Measures: OS, Overall survival measures the length of time from the start of treatment until death from any cause, indicating the effectiveness of the treatment in prolonging patients' lives., up to approximately 46 months|PFS, Progression-free survival measures the length of time during and after treatment that a patient lives with the disease without it progressing., up to approximately 46 months|DCR, DCR is the proportion of patients who have achieved complete response, partial response, or stable disease, up to approximately 46 months
AI-Assisted Rapid Warning for Mental Disorders Based on High-Resolution Fundus Imaging and High-Speed Eye-Tracking
NCT Number: NCT06511713
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Mental Disorder
Interventions: OTHER: routine clinical treatment
Sponsor: Shanghai Mental Health Center
Sex: ALL
Age: CHILD, ADULT
Enrollment: 2000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-20
Completion Date: 2025-12-30
Locations: Shanghai Mental Health Center, Shanghai, Shanghai, 200030, China

Summary:
This project aims to collect eye-tracking trajectories and fundus imaging data from individuals seeking mental health services. By utilizing artificial intelligence, combining dynamic (eye-tracking) and static (fundus) data, and employing convolutional neural network analysis methods, the investigators will develop models for the classification and early warning of common mental disorders. These models will assist clinicians in making objective diagnoses of common mental disorders and in predicting the risk of adverse outcomes, thereby addressing the significant technical bottleneck of the current lack of objective diagnostic and warning instruments for mental disorders.

Primary Outcome Measures: Eye-tracking fixation point trajectory, Eye-tracking fixation point trajectory during free viewing of specific images by the participant (5 minutes), 1 year|Fundus examination, Color fundus imaging collected by a digital fundus camera (Canon CR-2) under non-mydriatic conditions of the participant, 1 year
Effectiveness And Impact Of Nirsevimab In Chile (NIRSE-CL)
NCT Number: NCT06511687
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: RSV
Interventions: BIOLOGICAL: Nirsevimab
Sponsor: Instituto Sistemas Complejos de Ingeniería
Sex: ALL
Age: CHILD
Enrollment: 160000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-04-01
Completion Date: 2024-10-01
Locations: ISCI, Santiago, 8370398, Chile

Summary:
The Nirse-CL study is a collaborative effort between the Ministry of Health of Chile, Instituto Sistemas Complejos de Ingeniería (ISCI), and the Faculty of Medicine of the University of Chile. The primary aim is to determine the effectiveness of the monoclonal antibody nirsevimab in preventing RSV infection in infants based on the integrated analysis of several national databases before, during, and after the implementation of a universal immunization program. The impact of the program on RSV-related health outcomes will also be determined.

Primary Outcome Measures: LRTI, Number and incidence of lower-tract respiratory infections hospitalizations (LRTI) attributed to RSV in the pediatric intensive care units (PICU) at a nationwide and regional level., from April 2024 to October 2024
Prognostic Significance of the Uncertain Resection in NSCLC
NCT Number: NCT06511661
Status: ACTIVE_NOT_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Non Small Cell Lung Cancer|Residual; State
Interventions: PROCEDURE: Complete lymphadenectomy|PROCEDURE: Incomplete lymphadenectomy
Sponsor: Sun Yat-sen University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 3783
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-16
Completion Date: 2025-07
Locations: Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, 510060, China

Summary:
The concept of residual tumor classification proposed by the Union for International Cancer Control (UICC) was used to assess the completeness of surgical resection, and non-small cell lung cancer (NSCLC) patients with incomplete resection were more likely to occur recurrence, leading to significantly poor survival. But this R classification only refers to the surgical margin and neglects other factors associated with surgical quality, such as the extent of lymph node dissection (LND). Therefore, the International Association for the Study of Lung Cancer (IASLC) proposed the definition of uncertain resection \[R(un)\], which includes the suboptimal extent of LND. However, the clinical significance of R(un) is still controversial. On the one hand, some researches demonstrated that R(un) had definite prognostic significance, with R(un) survival stratifying between R0 and R1. On the other hand, some studies indicated that in early-stage NSCLC, the suboptimal extent of LND had no impact on survival, and the concept of R(un) might be insignificant in these patients. Even in those studies supporting the prognostic significance of R(un), which kind of patients is suitable for R(un) was still unclear. Thus, the investigators explore the impact of the R(un) on the long-term survival of patients with NSCLC using a large cohort in China, to identify those patients who could really benefit from the LND required by the R0 classification proposed by IASLC.

Primary Outcome Measures: 5-year disease-free survival, The disease-free survival rate 5 years after surgery, 5 years after surgery|5-year overall survival, The overall survival rate 5 years after surgery, 5 years after surgery
Multicenter Quantitative and Qualitative Study of the Determinants of Participation in a Cytomegalovirus Preventive Vaccine Study in France in Women Aged 18 to 40 Years Old.
NCT Number: NCT06511635
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Recruitment
Interventions: OTHER: Qualitative interview|OTHER: Quantitative questionnaire
Sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sex: FEMALE
Age: ADULT
Enrollment: 306
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09
Completion Date: 2024-11
Locations: Centre Hospitalier Universitaire de St Etienne, Saint-Étienne, 42055, France

Summary:
During a vaccine clinical trial of Cytomegalovirus (CMV) vaccine, one of the participants' motivations was to prevent an infection responsible for malformations in a future child. Would their attitude towards a vaccine trial be the same in the context of a vaccine designed to protect them individually? By improving the knowledge of clinical research and determinants in women aged 18 to 40, this study could improve recruitment methods in this specific population for future vaccine trials within the CIC1408 infectious diseases and vaccinology area at Saint-Etienne University Hospital.

Primary Outcome Measures: qualitative interview, To identify the motivations and the obstacles of participation in an experimental trial in women of childbearing age in Phase 3 trial., Day : 1
The Anti-reflux Effect of Double-flap Technique in Laparoscopic Proximal Gastrectomy.
NCT Number: NCT06511609
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Proximal Early Gastric Cancer
Interventions: PROCEDURE: double-flap technique（DFT）; double-tract reconstruction(DTR),
Sponsor: Changzhi People's Hospital Affiliated to Changzhi Medical College
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 244
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2027-07-31

Summary:
This study is a multicenter, open-label, prospective, randomized parallel-controlled trial. The purpose is to explore whether the incidence rate of reflux esophagitis (RE) within 12 months after surgery is non-inferior for the DFT group compared to the DTR group.

Primary Outcome Measures: Proportion of patients with reflux esophagitis, The percentage (%) of patients developing postoperative reflux esophagitis after surgery in the two group., Within 12 months after surgery
Secondary Outcome Measures: Postoperative complications, Evaluated using the Clavien-Dindo classification to assess the severity of postoperative complications., Within 12 months after surgery|Operation time, From the beginning of surgery to the end of surgery, Perioperative period|Kamikawa anastomosis time, The time of making the seromuscular flap and the time of esophagogastrostomy were included, Perioperative period|intraoperative blood loss, The operation begins to end the amount of bleeding., Perioperative period|Weight change, Calculated in kilograms, Within 12 months after surgery|Body Mass Index (BMI), weight and height will be combined to report BMI in kg/m\^2, Within 12 months after surgery|Albumin value, The concentration of albumin in the blood, expressed in g/L., Within 12 months after surgery|Pre albumin value, The concentration of pre albumin in the blood, expressed in g/L., Within 12 months after surgery|Hemoglobin value, The concentration of Hemoglobin in the blood, expressed in g/L., Within 12 months after surgery|Folic acid value, The concentration of Folic acid value in the blood, expressed in ng/mL., Within 12 months after surgery|Vitamin B12 value, The concentration of Vitamin B12 value in the blood, expressed in uug/L., Within 12 months after surgery|Ferritin value, The concentration of Vitamin B12 value in the blood, expressed in ug/L., Within 12 months after surgery|Nutritional risk screening 2002, The nutritional status is assessed using the Nutrition Risk Screening 2002 (NRS-2002) scale, with a scoring range of 0 to 7 points. A higher score indicates a worse nutritional status., Within 12 months after surgery
FBS-ASaP: Fibrobronchoscopy in ASpiration Pneumonia in the Emergency Department
NCT Number: NCT06511583
Acronym: FBS-ASaP
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Aspiration Pneumonia|Bronchoscopy
Interventions: PROCEDURE: Laryngotracheal Aspiration Procedure Using a Probe in the Emergency Department|PROCEDURE: Aspiration Procedure Using Fibrobronchoscopy in the Emergency Department
Sponsor: Azienda Ospedaliero-Universitaria Careggi
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-02-05
Completion Date: 2027-03-05
Locations: AOU Careggi, Florence, Tuscany/Italy, 50122, Italy

Summary:
Non-Profit Prospective Observational Pilot Study

The study will have an overall duration of 3 years, with patient enrollment starting after ethical committee approval.

In this study, all patients with a diagnosis of aspiration pneumonia who require aspiration of secretions or ingesta in the Emergency Department will be considered. A registry will be created with the patients\&#39; data, noting the type of procedure performed: laryngotracheal aspiration with a probe or with fibrobronchoscopy.

This observational registry pilot study aims to evaluate the utility and adverse events related to the use of aspiration via videobronchoscopy performed in the Emergency Department and to compare the clinical outcomes of patients undergoing bronchoscopy with those treated only with blind laryngotracheal aspiration using a probe.

Primary Outcome Measures: Length of hospital stay in days, Length of hospital stay in days, up to 3 months|Mortality rate within 30 days from the time of admission to the Emergency Department, Mortality rate within 30 days from the time of admission to the Emergency Department, 30 days from admission to the ed
Secondary Outcome Measures: Respiratory parameters before and after the procedure, (SpO2, FiO2)before and after the procedure, on the admission and 30 minutes after the procedure|Rate of patient treated with Non invase ventilation and with orotracheal intubation, Oxygen therapy devices before and after the procedure, on the admission and 30 minutes after the procedure|Rate of admission in Intensive care unit and High dependency unit, Hospitalization setting, immediately after the procedure|Procedure-related complications, Procedure-related complications, perioperatively/periprocedurally
A Study Comparing the Safety, Tolerability, and Pharmacokinetics of Sabirnetug IV and Sabirnetug + rHuPH20 SC in Healthy Participants
NCT Number: NCT06511570
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Alzheimer Disease
Interventions: DRUG: sabirnetug (ACU193)|COMBINATION_PRODUCT: Sabirnetug + rHuPH20
Sponsor: Acumen Pharmaceuticals
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 28
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-25
Completion Date: 2024-09-13
Locations: Worldwide Clinical Trials, San Antonio, Texas, 78217, United States

Summary:
A Study Comparing the Safety, Tolerability, and Pharmacokinetics of Sabirnetug IV and Sabirnetug + rHuPH20 SC in Healthy Participants

Primary Outcome Measures: Estimate blood levels of sabirnetug (ACU193), Cmax (Maximum concentration, determined directly from individual concentration-time data), Group 1: Day 1 (predose) up to Day 43 Group 2: Day 1 (predose) up to Day 50|Estimate time to reach maximum blood levels of sabirnetug (ACU193), Tmax (Time of the maximum concentration), Group 1: Day 1 (predose) up to Day 43 Group 2: Day 1 (predose) up to Day 50|Estimate blood levels of sabirnetug (ACU193), terminal rate, λz (The observed terminal rate constant; estimated by linear regression through at least three data points in the terminal phase of the log concentration-time profile), Group 1: Day 1 (predose) up to Day 43 Group 2: Day 1 (predose) up to Day 50|Estimate time to reach half-life blood levels of sabirnetug (ACU193), half-life, T1/2 (The observed terminal half-life), Group 1: Day 1 (predose) up to Day 43 Group 2: Day 1 (predose) up to Day 50|Estimate blood levels of sabirnetug (ACU193), concentration-time, AUC168h (Area under the concentration-time curve during a one-week dosing interval), Group 1: Day 1 (predose) up to Day 43 Group 2: Day 1 (predose) up to Day 50|Estimate blood levels of sabirnetug (ACU193), last concentration-time, AUClast (Area under the concentration-time curve from time zero to the time of the last quantifiable concentration; calculated using the linear trapezoidal rule), Group 1: Day 1 (predose) up to Day 43 Group 2: Day 1 (predose) up to Day 50|Estimate blood levels of sabirnetug (ACU193), infinity concentration-time, AUCinf (Area under the concentration-time curve from time zero extrapolated to infinity), Group 1: Day 1 (predose) up to Day 43 Group 2: Day 1 (predose) up to Day 50|Estimate blood levels of sabirnetug (ACU193), extrapolation, AUCExtrap (%)(The percentage of AUCinf based on extrapolation), Group 1: Day 1 (predose) up to Day 43 Group 2: Day 1 (predose) up to Day 50|Estimate blood levels of sabirnetug (ACU193), Clast, Clast (The last quantifiable concentration determined directly from individual concentration-time data), Group 1: Day 1 (predose) up to Day 43 Group 2: Day 1 (predose) up to Day 50|Estimate time to reach last blood levels of sabirnetug (ACU193), Tlast (Time of the last quantifiable concentration), Group 1: Day 1 (predose) up to Day 43 Group 2: Day 1 (predose) up to Day 50
rTMS to Target Neural Connectivity and Rumination in Treatment-Resistant Depression
NCT Number: NCT06511544
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Depression, Treatment Resistant
Interventions: DEVICE: Transcranial magnetic stimulation
Sponsor: Indiana University
Collaborators: National Center for Advancing Translational Sciences (NCATS)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-01-02
Completion Date: 2026-06-30
Locations: Goodman Hall Neuroscience Center, Indianapolis, Indiana, 46202, United States

Summary:
The goal of this clinical trial is to learn if Transcranial Magnetic Stimulation (TMS) to part of the brain called the ventromedial prefrontal cortex (VMPFC) can treat a symptom called rumination in adults with major depression that has not responded to at least one medication trial. The main question it aims to answer are:

Does TMS to the VMPFC change brain activity on functional magnetic resonance imaging (fMRI) during a negative self-referential processing task in adults with depression? Does TMS to the VMPFC affect rumination in adults with depression? Researchers will compare brain scans and rumination scores before, during, and immediately after TMS.

Participants will:

Undergo three functional MRI scans Undergo a course of 20 TMS treatments Respond to clinical questionnaires and complete a computer behavioral task

Primary Outcome Measures: Functional Connectivity, Within-network functional connectivity of the default mode network during negative processing, Before Transcranial magnetic stimulation (TMS) - immediately following TMS|Rumination, Scores on the Ruminative Response Scale (Range 22-88, with higher worse), Before TMS- immediately following TMS
Secondary Outcome Measures: Overall Depression Scores, Hamilton Depression Rating Scale (Range 0-52, with higher worse), Before TMS- immediately following TMS
Exploring Sarcopenia in Parkinson's Disease Patients by Combining Serum Biomarker Levels
NCT Number: NCT06511531
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Parkinson Disease
Sponsor: Central South University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-01
Completion Date: 2024-09-01

Summary:
Parkinson\&#39;s Disease (PD) and sarcopenia are prevalent age-related syndromes, often occurring simultaneously within individuals. Sarcopenia is notably common among PD patients, with severe cases affecting approximately one in every five individuals with PD. Moreover, sarcopenia is closely linked to the accelerated progression of PD, diminished quality of life, heightened mortality risk, and increased susceptibility to falls and fractures. Therefore, early detection of sarcopenia assumes particular significance as it offers an opportunity for interventions aimed at mitigating or delaying muscle degeneration, potentially influencing PD outcomes. This review will delve into the relationship between sarcopenia and PD, methods for screening and testing sarcopenia, and potential avenues for further research and the development of strategies for risk reduction and treatment

Primary Outcome Measures: the SARC-F, The SARC-F is a simple screening tool for sarcopenia, consisting of five questions on strength, assistance in walking, rising from a chair, climbing stairs, and falls. Each question is scored from 0 to 2, with a total score of 4 or more indicating a risk of sarcopenia., 12 months
Secondary Outcome Measures: Low Muscle Mass, The Skeletal Muscle Mass Index (SMI) is a measure used to assess muscle mass relative to a person's height. It is calculated by dividing the total skeletal muscle mass (usually obtained through techniques like DXA or BIA) by the square of the individual's height (in meters), 12 months|Low Muscle Strength, Commonly assessed using grip strength tests, 12 months|Poor Physical Performance, Evaluated through tests like gait speed, the Short Physical Performance Battery (SPPB), or the Timed Up and Go (TUG) test., 12 months
NOrthwestern Tempus AI-enaBLed Electrocardiography (NOTABLE) Trial
NCT Number: NCT06511505
Acronym: NOTABLE
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Atrial Fibrillation|Cardiovascular Diseases|Arrhythmia|Valvular Disease
Interventions: OTHER: TEMPUS AI-enabled ECG-based Screening Tool
Sponsor: Northwestern University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1000
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SCREENING
Start Date: 2024-08-03
Completion Date: 2026-02-03
Locations: Northwestern University, Chicago, Illinois, 60611, United States

Summary:
The goal of this clinical trial is to determine if a machine learning/artificial intelligence (AI)-based electrocardiogram (ECG) algorithm (Tempus Next software) can identify undiagnosed cardiovascular disease in patients. It will also examine the safety and effectiveness of using this AI-based tool in a clinical setting. The main questions it aims to answer are:

1. Can the AI-based ECG algorithm improve the detection of atrial fibrillation and structural heart disease?
2. How does the use of this algorithm affect clinical decision-making and patient outcomes? Researchers will compare the outcomes of healthcare providers who receive the AI-based ECG results to those who do not.

Participants (healthcare providers) will:

Be randomized into two groups: one that receives AI-based ECG results and one that does not.

In the intervention group, receive an assessment of their patient's risk of atrial fibrillation or structural heart disease with each ordered ECG.

Decide whether to perform further clinical evaluation based on the AI-generated risk assessment as part of routine clinical care.

Primary Outcome Measures: Rate of new CV diagnoses at 6 months, Rate of new CV diagnoses will be defined for each predictive model and a composite of all models, and comparisons will be made between intervention and control groups.

AF: New AF diagnosis SHD: New diagnosis of moderate or severe aortic stenosis, aortic regurgitation, or mitral stenosis, new diagnosis of severe mitral regurgitation or tricuspid regurgitation, new diagnosis of LVEF ≤40%, new diagnosis of significant left ventricular hypertrophy (IVSd \>15 mm)., 6 months
Secondary Outcome Measures: Rate of new CV therapies at 6 months, Rate of new CV therapies will be evaluated for each predictive model and a composite of all models, comparisons will be made between intervention and control groups.

AF: antiarrhythmic use, AV nodal blocking agent use, anticoagulation use, AF ablation procedure SHD: new use of medication for LV systolic dysfunction (beta blockers, ACE-I/ARB/ARNI, MRA, SGLT2-I), new therapies for valvular heart disease (valve repair or replacement), new therapies for HCM, cardiac amyloidosis, hypertensive heart disease., 6 months|Rate of CV outcomes at 6 months, Rate of CV outcomes including CV death, MI, and hospitalization for a cardiovascular cause (including heart failure and stroke) between intervention and control groups., 6 months
Longitudinal Surveillance of Rectal Colonization and Transmission by Resistant Bacteria in Acutely Decompensated Cirrhosis
NCT Number: NCT06511492
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Cirrhosis, Liver|Rectal Colonization|Multidrug Resistance Organisms
Interventions: OTHER: No intervention in this study
Sponsor: Nanfang Hospital, Southern Medical University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1289
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-25
Completion Date: 2026-08-01

Summary:
Antimicrobial resistance has emerged as a global threat, and multidrug resistance organisms (MDROs) form one of the foremost challenges in the setting of decompensated cirrhosis. In a worldwide study, a high prevalence (34%) of infection with MDR bacteria in patients with cirrhosis and associated with higher in-hospital mortality.

Previous study indicated that the pattern of colonized bacteria in heterogeneous and the colonization by MDROs is associated with increased risk of infection. Effort should be made to reduce the spread of MDR bacteria and improvement in prognosis in patents with cirrhosis. Currently, strategies suggested to prevent the spread of MDROs in cirrhosis, including rapid microbiological tests, new first-line antibiotic schedules, infection control practices and epidemiological surveillance.

Thus, for the aims of this cohort study are as following. Firstly, to characterize the burden, dynamics and risk factors associated with rectal colonization by MDROs in patients with cirrhosis. Secondly, to completely characterize the risk that asymptomatic carriers of MDROs, both to other patients and to themselves via collecting detailed longitudinal sampling and high-resolution typing. Lastly, to generate evidence for future policymaking for individualized antimicrobial decision rather than umbrella guidelines since the variance in the bacteriological profiles in different settings.

Primary Outcome Measures: The prevalence of rectal colonization by MDROs in patients with cirrhosis, The prevalence of rectal colonization by MDROs in patients with cirrhosis during hospitalization, 90 days|The onset of infection with MDR bacteria in cirrhosis patients with asymptomatic carriers, The onset of infection with MDR bacteria in cirrhosis patients with asymptomatic carriers and describe the risk of colonization both to other patients and to themselves., 90 days
Secondary Outcome Measures: The risk factors associated with rectal colonization by MDROs in patients with cirrhosis., 90 days
Assessment of an Automated Optical Coherence Tomography and Camera : Reference Database
NCT Number: NCT06511440
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Healthy
Interventions: DEVICE: Vision-700
Sponsor: Crystalvue Medical Coporation
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 285
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-09-01
Completion Date: 2023-10-31
Locations: Tri-Services General Hospital, Taipei county, Taiwan

Summary:
The objective of this study is to establish the Reference database of Vision-700.

Primary Outcome Measures: The reference OCT data, The study is to collect OCT measurement data on normal healthy eyes in order to establish the reference data range for OCT parameters, included full retinal thickness (μm), retinal nerve fiber layer (μm), ganglion cell complex thickness (μm) and optic nerve head (μm). The reference data range will provide it with the doctor to dignoisis., 2022/09/01
Difficult Airways Scores Validation Difficult Laryngoscopy and Mask Ventilation: Prospective and Evaluative Study
NCT Number: NCT06511427
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Airway Complication of Anesthesia|Ultrasound|Laryngoscopy|Difficult Airways
Interventions: DIAGNOSTIC_TEST: upper airway sonography|DIAGNOSTIC_TEST: upper airway sonography
Sponsor: Mongi Slim Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-15
Completion Date: 2024-12-30

Summary:
Clinical screening tests were included to define a difficult laryngoscopy such as history of difficult or impossible intubation, NC, MMS, retrognathia, protrusion of the upper incisors, TMD, mouth opening, dentition, macroglossia, presence of a beard, UBLT, spine mobility and palm print test for diabetes.

Ultrasound airway assessment was performed: Clinical screening tests were included to define a difficult laryngoscopy such as history of difficult or impossible intubation, NC, MMS, retrognathia, protrusion of the upper incisors, TMD, mouth opening, dentition, macroglossia, presence of a beard, UBLT, spine mobility and palm print test for diabetes.

Ultrasound airway assessment was performed Three parameters were measured to calculate the scores: Tongue thickness (TT) in coronal plane, Distance from the skin to hyoid bone (SHB), Distance from the skin to the thyrohyoid membrane (STM). Two scores were developed from a study conducted in 2019. The first score, to predict a difficult laryngoscopy, uses two parameters: the modified MALLAMPATI class (MMS) and the STM. A score strictly greater than 2 is predictive of a difficult laryngoscopy. The second score, to predict difficult ventilation, uses four parameters: BMI, NC, TT in coronal plane, and SHB. A score strictly greater than 20 is predictive of difficult ventilation. A well-experienced anesthesiologist performed a direct laryngoscopy and graded it as Cormack-Lehane's grading.

Difficulty in intubation and/or mask ventilation was managed according to the 2017 SFAR guidelines.

Primary Outcome Measures: difficult laryngoscopy, cormack-lehane grade (from 1 to 4: 1 and 2 correspond to easy laryngoscopy and 3 or 4 to difficult laryngoscopy, 3 min after induction of general anesthesia
Secondary Outcome Measures: Difficult intubation, intubation requiring more than two laryngoscopies and/or the use of an alternative technique after optimizing head position (amended Jackson), with or without external laryngeal manipulation (BURP: backwards, upwards, and rightwards pressure), 3 minutes after induction of general anesthesia|Difficult mask ventilation, 1. Inability to achieve sufficient chest expansion or a tidal volume greater than dead space (3 ml/kg), an identifiable capnographic trace, or maintain SpO2 \&gt; 92% or the Necessity to use rapid oxygen multiple times or call for another operator or the Insufflation pressure greater than 25 cmH2O;, 3 minutes after induction of general anesthesia
Effect of Duramesh™ on Hernia Formation After Ileostomy Closure, Randomized Controlled Trial
NCT Number: NCT06511414
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Incisional Hernia|Ileostomy - Stoma
Interventions: DEVICE: duramesh|DEVICE: Control
Sponsor: Northwestern University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 106
Study Design: Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-01-03
Completion Date: 2026-12
Locations: Northwestern University Feinberg School of Medicine, Chicago, Illinois, 60611, United States

Summary:
Diverting ileostomy is frequently utilized to protect high-risk anastomoses, though it is not shown to reduce the leak rate it may reduce the severe consequences of an anastomotic leak. Ileostomy will be reversed with restoration of continuity in majority of patients. Stoma site incisional hernias after ileostomy closure are complex hernias that can be associated with abdominal pain, discomfort, and a diminished quality of life. Duramesh™ non-absorbable polypropylene suture is a hollow core, microporous, cylindrical suture made off in polypropylene filaments that are loosely braided and bonded to each other with heat and pressure. The Aim of this study is to evaluate Duramesh™ suture vs standard closure on rates of hernia formation after ileostomy closure.

Primary Outcome Measures: hernia rates, Compare hernia rates after ileostomy closure between Duramesh™ and standard monofilament closure, 1 year
Secondary Outcome Measures: infection rate, Evaluate potential side effects including infections and need for re intervention associated with Duramesh™ vs standard closure, 1 year
Informing Pain Treatment Using Pharmacogenomic Analysis
NCT Number: NCT06511401
Acronym: C-PAIN
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Analgesia|Cancer|CYP2D6
Interventions: OTHER: Pharmacogenomic (PGx) results.
Sponsor: University of Chicago
Collaborators: National Human Genome Research Institute (NHGRI)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 800
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2025-02
Completion Date: 2028-08
Locations: University of Chicago Medicine Comprehensive Cancer Center, Chicago, Illinois, 60637, United States

Summary:
This is a randomized, prospective study to evaluate the effects of preemptive pharmacogenomic (PGx) testing on opioid dosing decisions/selections and pain score in cancer patients.

Primary Outcome Measures: Pain control., Measuring changes in composite pain intensity rating via the numeric rating scale:

* Brief Pain Inventory-Short Form (BPI-SF)
* Score range: 0 (no pain) to 10 (most pain)
* Composite pain intensity score (mean of worst, least, average, and current pain)

From baseline to day 45 in patients receiving an index opioid prescription for codeine, tramadol, or hydrocodone., 45 days
Secondary Outcome Measures: Pain Medication Regimen Changes, Pain medication regimen changes will be assessed for patients who were taking an opioid metabolized primarily by CYP2D6. Pain medication regimen changes from baseline to day 45. The timing of subsequent changes in pain regimes after initial opioid selection will also be recorded., 45 days|Hospitalization or Emergency Visit for Pain Control, The rates of hospitalization and emergency room visits for pain are examined with the rates of increased utilization of health care resources, such as emergency department visits, hospitalizations, and pain consultations. Rates of hospitalization or emergency room visits from baseline to day 45., 45 days|Cumulative Morphine, Cumulative Morphine Equivalents will be defined as total amount of opioids taken by a patient that is converted into its morphine equivalent. Dose and frequency of each opioid given during 45 days after its index prescription will be considered during calculation to give final values, which will be compared to Cumulative Morphine Equivalents for Control arms treated per standard of care., 45 days|Composite Pain Intensity, Composite Pain Intensity will represent a singular score that amalgamates the worst, least, average, and current pain scores, calculated by taking their mean. Each score will be assessed using numeric rating scale from Brief Pain Inventory-Short Form (BPI-SF). A composite pain intensity score (mean of worst, least, average, and current pain) will be used., 45 days
Cardiotoxic Effects of Chemotherapy in Patients With Sarcomas: A Two and Three-dimensional Echocardiographic Speckle Tracking Imaging Study
NCT Number: NCT06511388
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Sarcoma
Interventions: OTHER: Non-Interventional Study
Sponsor: Mayo Clinic
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 400
Study Design: Observational Model: |Time Perspective: p
Start Date: 2016-01-20
Completion Date: 2028-01-20
Locations: Mayo Clinic in Rochester, Rochester, Minnesota, 55905, United States

Summary:
This study is being done to identify markers that will allow researchers to identify in advance patients with sarcomas who are at highest risk for developing heart failure related to chemotherapy.

Primary Outcome Measures: Changes in myocardial function - 2D-STE, Changes in myocardial function will be assessed using 2D-STE derived strain rate. Changes will be compared to baseline over time., Baseline, 3 months, 6 months, 1 year|Changes in myocardial function - 2D-STE vs 3D-STE, Differences between two-dimensional speckle tracking echocardiography (2D-STE) and three-dimensional speckle tracking echocardiography (3D-STE) derived strain will be compared at baseline and over time., Baseline, 3 months, 6 months, 1 year|Changes in myocardial function - 2D-STE vs 2D-LVEF and 3D-LVEF, Differences between 2D-STE and 2D- and 3D- left ventricle ejection fraction (2D-LVEF and 3D-LVEF, respectively) will be compared at baseline and over time., Baseline, 3 months, 6 months, 1 year|Changes in myocardial function - 2D-STE vs cardiac biomarkers, If feasible, 2D-STE and cardiac biomarkers \[serum cardiac troponin T and N-terminal fragment of brain natriuretic peptide (NT-proBNP)\] will be compared at baseline and over time., Baseline, 3 months, 6 months, 1 year
Comparative Effects of Sprint and Power Training in Cricket Fast Bowlers
NCT Number: NCT06511375
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Sports Physical Therapy
Interventions: OTHER: sprint training|OTHER: Power Training
Sponsor: Riphah International University
Sex: ALL
Age: ADULT
Enrollment: 34
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2023-02-15
Completion Date: 2024-08-25
Locations: Zafarwal playzone, Zafarwal, Punjab, 51670, Pakistan

Summary:
Sprints can be a really effective way to improve participants cardiovascular fitness, strength and power, and running economy. Participants can gain bigger improvements and in less time with sprinting than with continuous easy running. Power training typically involves exercises which apply the maximum amount of force as fast as possible. Both these trainings are vital to increase the speed and repeated sprint ability in cricket fast bowlers.

Primary Outcome Measures: Speed, speed is assessed by 10-m sprint test. participants will run for 10 meters on the sound of GO. the time taken for the completion of 10 meter track will be recorded by a handled stopwatch. Measurements will be taken before and after 10-m sprint test., 10 months|Repeated Sprint Ability, Repeated-sprint ability (RSA) is now well accepted as an important fitness component in team-sport performance. It is broadly described as the ability to perform repeated short (\~3-4 s, 20-30 m) sprints with only brief (\~10-30 s) recovery between bouts. measurements will be taken before and after the repeated sprint ability test., 10 months
Clinical Exploration Study of YOLT-203 in the Treatment of Type 1 Primary Hyperoxaluria (PH1)
NCT Number: NCT06511349
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: EARLY_PHASE1
Conditions: Type 1 Primary Hyperoxaluria
Interventions: DRUG: YOLT-203
Sponsor: RenJi Hospital
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 7
Study Design: Allocation: NA|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-12
Completion Date: 2026-01-31
Locations: Deparment of Liver Surgery, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, Shanghai, 200127, China

Summary:
This study is a single-arm, open-label, single-dose, dose-escalation trial, aiming to evaluate the safety and tolerability of YOLT-203 in the Chinese population with type 1 primary hyperoxaluria (PH1); and to preliminarily assess the effect of a single dose of YOLT-203 on the plasma oxalate level.

In this study, the maximum screening period of the main study is 60 days, the treatment day is Day 1 (D1), and the safety follow-up period is up to Week 52 after administration. In addition, subjects within the first dose group can voluntarily receive a second treatment with the test drug at the effective dose level.

After the end of the main study, the subjects will undergo long-term follow-up. According to the requirements of the "Technical Guidelines for Long-Term Follow-up Clinical Studies of Gene Therapy Products (Trial)" issued by the CDE, the long-term follow-up is up to 15 years after administration.

Primary Outcome Measures: Safety and Tolerability, Incidence and severity of adverse events (AEs) and serious adverse events (SAEs), through week 52
Secondary Outcome Measures: pharmacokinetics of YOLT-203, The Peak Plasma Concentration (Cmax) of YOLT-203. 0.5 predose,2,6,24,48,72,144,312 hours, through Day 14|pharmacokinetics of YOLT-203, Area under the plasma concentration versus time curve (AUC). 0.5 predose,2,6,24,48,72,144,312 hours, through Day 14|pharmacokinetics of YOLT-203, Tmax, through Day 28|pharmacokinetics of YOLT-203, T1/2, through Day 28|pharmacodynamics, After medication, at 1, 2, 4, 8, 16, 24, 36, and 52 weeks, the changes in blood glycolic acid levels, through week 52|pharmacodynamics, After medication, at 2, 8, 16, 24, and 52 weeks, the changes in 24-hour urinary oxalic acid excretion compared to the baseline value., through week 52|pharmacodynamics, After medication, at 1, 2, 4, 8, 16, 24, 36, and 52 weeks, the changes in 24-hour urinary glycolic acid excretion, through week 52|pharmacodynamics, After medication, at 1, 2, 4, 8, 16, 24, 36, and 52 weeks, the changes in eGFR., through week 52
Alkaline Water and Salivary Bacterial Count
NCT Number: NCT06511336
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Dental Caries
Interventions: DRUG: Alkaline water (FLO water- Bottled drinking water- the Egyption Saudi Company for natural water- made in Egypt
Sponsor: Pharos University in Alexandria
Sex: ALL
Age: CHILD
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: PREVENTION
Start Date: 2024-07-01
Completion Date: 2024-08-15
Locations: Pharos University in Alexandria, Alexandria, 536733, Egypt

Summary:
This study will be aimed to examine the effect of alkaline water on salivary streptococcus mutans bacteria which is the main cause of dental caries and comparing its effect with chlorohexidine mouthwash on the children aged 10-12. tap water will be used as mouthwash for negative control group.

Primary Outcome Measures: Salivary streptococcus mutans count, the count of salivary coccus mutans bacteria which is the main cause of dental cariea, 3 weeks