pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Effect of Sex on Orthostatic Intolerance and Cardiovascular Response During Lunar Descent and Ascent
NCT Number: NCT06467825
Acronym: Lunar OI
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Healthy
Interventions: DRUG: Potassium Supplement|DRUG: Furosemide 20 MG|DEVICE: Compression Garment
Sponsor: National Aeronautics and Space Administration (NASA)
Sex: ALL
Age: ADULT
Enrollment: 38
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2022-08-09
Completion Date: 2025-09
Locations: NASA, Houston, Texas, 77058, United States

Summary:
The purpose of Lunar OI (Orthostatic Intolerance) is to determine if there are differences between males and females in tolerance to and cardiovascular responses during different angles of head-up tilt simulating gravity levels less than or equal to Earth's gravity. Also, this study will determine if a gradient compression garment affects tolerance to tilting and the cardiovascular stress at different tilt angles. Males and females are being identified by biological sex. This will be a two-phased study design. In Phase I we will determine whether there are differences in the development of signs or symptoms of orthostatic intolerance between males and females when tilted head up on a table to different angles to simulate gravity levels that astronauts may experience when landing on or launching from the surface of the Moon. In Phase II, the tilt tests simulating the same gravity levels from Phase I will be repeated, but a custom-made lower-body compression garment will be worn to see if wearing the garment affects the development of orthostatic intolerance. For both study phases, before tilting, a drug will be administered to reduce the amount fluid in the blood (plasma) to levels similar to that experienced by astronauts during spaceflight.

Primary Outcome Measures: Plasma Volume, Plasma volume and change in plasma volume is calculated using the Dill and Costill equation cited here: Dill DB, Costill DL. Calculation of percentage changes in volumes of blood, plasma, and red cells in dehydration., 7-8 hours|Tilt Tolerance Time, duration of Tilt Test, 0-20 minutes|Heart Rate, beats per minute, 0-20 minutes|Blood Pressure, systolic and diastolic, continuous blood pressure, 0-20 minutes
Fluid Loading Countermeasures
NCT Number: NCT06467812
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Healthy
Interventions: DIETARY_SUPPLEMENT: Salt Tablets|DIETARY_SUPPLEMENT: Electrolyte Solution
Sponsor: National Aeronautics and Space Administration (NASA)
Sex: ALL
Age: ADULT
Enrollment: 15
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2022-04-01
Completion Date: 2024-10
Locations: NASA, Houston, Texas, 77058, United States

Summary:
The purpose of Fluid Loading Countermeasures is to determine how the volume of blood and of plasma (liquid part of blood) change during a normal day, how these are affected by drinking an additional amount of fluid either as water and salt tablets (as astronauts do) or an electrolyte beverage (similar to but tastes saltier than Gatorade®), and how altering the timing at which the additional fluid is consumed affects blood and plasma volume. This study observes how blood volume changes over \~9 hours of the day during 4 separate visits in healthy participants. During 1 visit participants will drink a small amount of water throughout the visit. During the other 3 study visits participants will drink the small amount of water plus either more water with salt tablets or an electrolyte solution. Consuming the additional fluids is called "fluid loading". This study is meant to simulate the food and fluid consumption of astronauts on landing day. The goal of this study is to determine the magnitude of plasma volume change that occurs with each condition of the protocol. (ICF 1.1, 3.1)

Primary Outcome Measures: Plasma Volume, Plasma volume and change in plasma volume is calculated using the Dill and Costill equation cited here: Dill DB, Costill DL. Calculation of percentage changes in volumes of blood, plasma, and red cells in dehydration., 8-9 hours|Fluid Balance, Urine output subtracted from fluid intake (mL), 8-9 hours|Gastrointestinal Distress, Open response questionnaire self-reported symptoms, 8-9 hours|Urine Volume, void-by-void urine output collected and measured (mL), 8-9 hours
Study on the Therapeutic Effect of Irinotecan Liposomes in Small Cell Lung Cancer
NCT Number: NCT06467786
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Small Cell Lung Cancer
Interventions: DRUG: Irinotecan hydrochloride liposome injection
Sponsor: Tang-Du Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 24
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-03-15
Completion Date: 2028-09-15
Locations: Tangdu Hospital, Xi'an, Shannxi, 710038, China

Summary:
This study is a prospective, multicenter, single arm Phase II exploratory study. It is expected to include 24 first-line patients with small cell lung cancer who have progressed after 6 months of treatment with platinum containing regimens, and receive treatment with irinotecan liposomes combined with cisplatin or carboplatin regimens.

Primary Outcome Measures: Intracranial Objective response rate, Per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) using Investigator assessments, is defined as the number (%) of patients with response of Complete Response or Partial Response, will be assessed up to 1 years., Data obtained up until progression, or the last evaluable assessment in the absence of progression, will be assessed up to 1 years.
Secondary Outcome Measures: Progression-free survival, Progression free survival (PFS) refers to the time from recording the first chemotherapy treatment to the date of disease progression, as assessed by researchers., Progression-free survival (PFS) analysis based on investigator assessment per RECIST 1.1, and will be assessed up to 4 years|Duration of Response, Duration of Response（DoR）refers to the time from the first assessment as CR or PR to the first assessment as PD or (due to any reason) death, Duration of Response（DoR）analysis based on investigator assessment per RECIST 1.1, and will be assessed up to 4 years|Overall Survival, Overall survival (OS) refers to the time that researchers evaluate from recording the first chemotherapy to death (of any cause)., The maximum time from receiving treatment to dying for any reason is 4 years.|Safety/Adverse event, Incidence of Adverse Events (AEs): Incidence, severity and seriousness of adverse events, incidence of serious adverse events (SAEs), which usually be graded by CTCAE v5.0 based on current clinical practice., From the first recorded chemotherapy to 4 weeks after the last recorded chemotherapy
Thumb Hemi-Arthroplasty With Natural Kinematics; a Prospective Multicenter Study to Confirm the Safety and Efficacy of the InDx Implant
NCT Number: NCT06467760
Acronym: THANKS PRO
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: CMC Joint Arthritis
Interventions: DEVICE: InDx CMC Implant
Sponsor: Loci Orthopaedics
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 73
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07
Completion Date: 2026-07

Summary:
Prospective, multicentric non-comparative confirmatory study to evaluate the safety and performance of the InDx CMC implant for the treatment of CMC joint arthritis.

Primary Outcome Measures: Device Safety, Determine the incidence of device failure, encompassing mechanical malfunction, structural compromise, loss of functionality due to device failure, or any deviation from the device's intended medical purpose. This will involve monitoring for adverse events requiring total revision surgery, or premature termination of device usage due to device failure., 6 Months|Performance, Measure the improvement in hand and wrist functionality using the Disabilities of the Arm, Shoulder, and Hand (DASH) score., 12 Months|Performance, Measure the improvement in hand and wrist functionality using the Patient-Rated Wrist/Hand Evaluation (PRWHE), 12 Months
The Efficacy of Music on Perioperative Pain Management
NCT Number: NCT06467747
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Perioperative Pain Management
Interventions: OTHER: Music|OTHER: Mute
Sponsor: Taichung Tzu Chi Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 90
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-03
Completion Date: 2025-05
Locations: Taichung Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, Taichung, Not In USA, 427, Taiwan

Summary:
The goal of this clinical trial is to learn if intraoperative music stimulation works to alleviate perioperative pain in surgical patients undergoing general anesthesia. It will also learn about the possible mechanisms by how music affects pain.

The main questions it aims to answer are:

Does music lower the number of times participants need to use a rescue analgesic? What changes occur in electroencephalogram (EEG) and nociception monitors when participants listen to music? Researchers will compare music to mute or control (hear ambient sounds without earphones) to see if music works to alleviate perioperative pain.

Participants will listen music or mute or ambient sounds throughout the operation, and receive routine anesthesia care.

Primary Outcome Measures: Numeric Rating Scale (NRS), To assess pain severity using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable". Higher scores indicate greater pain intensity., 1. While in the post-anesthesia care unit, for an average of 1 hour. 2. 24 hours after surgery.
Secondary Outcome Measures: Analgesic-frequency, Frequency of analgesic usage, 1. During the operation. 2. While in the post-anesthesia care unit, for an average of 1 hour. 3. 24 hours after surgery.|Analgesic-total amount, Total amount of analgesic used, 1. During the operation. 2. While in the post-anesthesia care unit, for an average of 1 hour. 3. 24 hours after surgery.|Post-operative nausea and vomiting (PONV), Frequency of nausea and vomiting episodes, 1. While in the post-anesthesia care unit, for an average of 1 hour.
Low Voltage Electrical Stimulation for Depression in Parkinson's Patients
NCT Number: NCT06467695
Acronym: LVESDIPP
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Parkinson Disease|Depressive Symptoms
Interventions: DEVICE: BIOPAC Stimsola|DEVICE: BIOPAC Stimsola Sham (zero amps)
Sponsor: University of South Alabama
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2026-09-28

Summary:
The goal of this clinical trial is to determine the relative efficacy of fMRI model guided Transcranial Direct Current Stimulation (mgTDCS) in improving the depressive symptoms of patients with Parkinson's Disease (PD). The main questions it aims to answer are: 1) Can the use of mgTDCS significantly improve the self-reported level of depression and apathy in patients with PD from pre-intervention to post-intervention compared to a sham control? 2) Can the use of mgTDCS significantly normalize the cortical eeg alpha asymmetry so commonly seen in depressed patients compared to sham mgTDCS? 3) Can the use of mgTDCS significantly improve scores on neuropsychological tests of working memory?

Primary Outcome Measures: Beck Depression Inventory (BDI) Pre-post change score, The BDI, a self-report measure for assessing depression, has high internal consistency (Cronbach's alpha \> .90) and good test-retest reliability., One at Day 1 and one after 15 sessions of training, typically 4 weeks after study start.|Alpha band power pre-post change score, Alpha band power from pre-post eeg records will be assessed for power changes at frontal sites., One at Day 1 and one after 15 sessions of training, typically 4 weeks after study start.|RBANS Working Memory, Digit Span and Story Memory subtests will be used to determine changes in working memory., One at Day 1 and one after 15 sessions of training, typically 4 weeks after study start.
Secondary Outcome Measures: PDQ-39, This a common measure to assess patient quality of life in Parkinson Disease patients involved in research., One at Day 1 and one after 15 sessions of training, typically 4 weeks after study start.
Adebrelimab Plus Chemo and Recaticimab Perioperative Treatment for Resectable NSCLC
NCT Number: NCT06467617
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Non Small Cell Lung Cancer
Interventions: DRUG: Adebrelimab plus albumin-bound paclitaxel, carboplatin and recaticimab
Sponsor: Beijing Chest Hospital, Capital Medical University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 35
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-01
Completion Date: 2026-12-01
Locations: Beijing Chest Hospital, Beijing, Beijing, 101125, China

Summary:
Current studies confirmed that the immune peri-operative treatment with combination chemotherapy curative effect and safety of resectable NSCLC, but its short-term curative effect and long-term survival benefit remains to be further improved to explore the new way of immune combination therapy.

Experimental study showed that the inhibition of PCSK9 could significantly increase in tumor cells of the immune response in mice, inhibit the PCSK9 enhanced anti-tumor immune response of mice can be further coordinate with immune checkpoint therapy, forming a lasting anti-tumor immune effect.

There are no reports on the peri-operative treatment of immune combined with chemotherapy and PCSK-9 inhibitors in patients with resectable NSCLC.

Based on the above, the aim of this study is to explore the efficacy and safety of Adebrelimab combined with recaticimab and chemotherapy in the peri-operative treatment of patients with resectable NSCLC.

Primary Outcome Measures: pCR, Pathological complete response；, 1.5 year
Secondary Outcome Measures: MPR, major pathologic response, through study completion, an average of 2 year|ORR, Objective response rate, through study completion, an average of 2 year|EFS, Event free survival, through study completion, an average of 2 year|DFS, Disease free survival, through study completion, an average of 2 year
CRAVE Study: Comparing Craving Responses and Diet Quality of GLP1 Receptor Agonist Users
NCT Number: NCT06467604
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Obesity
Interventions: BEHAVIORAL: Surveys|OTHER: Indirect Calorimetry|OTHER: Body composition|OTHER: Anthropometrics
Sponsor: University of California, Davis
Collaborators: Knownwell
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 150
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-12
Completion Date: 2025-12-31
Locations: Knownwell, Needham, Massachusetts, 02492, United States

Summary:
This study aims to assess the impact of GLP-1 receptor agonists, semaglutide and tirzepatide, on food cravings and diet quality in individuals with overweight or obesity. Over 24 weeks, up to 150 adult participants will be monitored using questionnaires and dietary records at 0, 12, and 24 weeks to measure changes in diet quality, disordered eating, food cravings, and hunger. This research, conducted with Seen Medical Group at Knownwell Health Clinic, seeks to fill the gap in literature on the dietary quality effects of GLP-1RAs.

Primary Outcome Measures: Change in Food Craving Score, Effect of GLP1 medications on food cravings measured by the food-craving inventory (FCI-II) questionnaire.The FCI-II is scored on a Likert scale from 1-5, with 1 being "Never," 5 being "Always/Almost every day.", Baseline, Midpoint (8-12 weeks), End of study (24 + 2 weeks)
Secondary Outcome Measures: Change in USDA Healthy Eating Index-2015 (HEI) Score, Effect of GLP1 medications on Healthy Eating Index-2015. The scores range from 0 to 100. An ideal overall HEI score of 100 reflects that the set of foods aligns with key dietary recommendations and dietary patterns published in the Dietary Guidelines., Baseline, Midpoint (8-12 weeks), End of study (24 + 2 weeks)
Other Outcome Measures: Changes in weight in kilograms, Effect of GLP1 medications on weight (in kg), Baseline, Midpoint (8-12 weeks), End of study (24 + 2 weeks)|Changes in waist circumference (cm), Baseline, Midpoint (8-12 weeks), End of study (24 + 2 weeks)|Changes in resting metabolic rate (RMR), Effect of GLP1 medications on resting metabolic rate, assessed by indirect calorimetry., Baseline, Midpoint (8-12 weeks), End of study (24 + 2 weeks)|Change in weight loss percentage, Baseline, Midpoint (8-12 weeks), End of study (24 + 2 weeks)|Changes in body fat percentage, Measured by seca mBCA 554 bioelectrical impedance analysis, Baseline, Midpoint (8-12 weeks), End of study (24 + 2 weeks)|Changes in skeletal muscle mass (lbs), Measured by seca mBCA 554 bioelectrical impedance analysis, Baseline, Midpoint (8-12 weeks), End of study (24 + 2 weeks)|Changes in visceral fat mass (L), Measured by seca mBCA 554 bioelectrical impedance analysis, Baseline, Midpoint (8-12 weeks), End of study (24 + 2 weeks)|Changes in segmental skeletal muscle mass (lbs), Measured by seca mBCA 554 bioelectrical impedance analysis, Baseline, Midpoint (8-12 weeks), End of study (24 + 2 weeks)
Prediction Model for Advanced Gastric Cancer in Elderly
NCT Number: NCT06467591
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Stomach Neoplasms|Aged
Sponsor: Chang-Ming Huang, Prof.
Sex: ALL
Age: OLDER_ADULT
Enrollment: 1436
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-01-01
Completion Date: 2024-05-20
Locations: Department of Gastric Surgery， Fujian Medical University Union Hospital, Fuzhou, Fujian, China

Summary:
This study aims to develop and validate a Nomogram (mCNS) model for predicting long-term survival in elderly patients following curative resection for advanced gastric cancer. The study is a retrospective multi-center analysis involving 924 gastric cancer patients treated at the Department of Gastrointestinal Surgery of the Affiliated Union Hospital of Fujian Medical University between 2009 and 2013, and 512 patients aged 65 and above who underwent gastric resection at the Affiliated Zhongshan Hospital of Dalian University between 2011 and 2018. An online prognostic tool is introduced to assist clinicians in predicting patient prognosis and customizing treatment and follow-up strategies.

Primary Outcome Measures: 5-Year Overall Survival, The proportion of patients who are alive at five years after treatment for elderly gastric cancer patients., 5 years or 60 months.
Secondary Outcome Measures: 3-Year Overall Survival, The proportion of patients who have survived without any signs or symptoms of gastric cancer for 3 years after the initial treatment., 3 years or 36 months.|1-Year Overall Survival, The proportion of patients who have survived without any signs or symptoms of gastric cancer for 1 years after the initial treatment., 1 years or 12 months.
NALIRIFOX as Induction Therapy in LAPC
NCT Number: NCT06467565
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Pancreatic Ductal Adenocarcinoma
Interventions: DRUG: Liposomal irinotecan
Sponsor: The First Affiliated Hospital with Nanjing Medical University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-12-25
Completion Date: 2025-12-31
Locations: The First Affiliated Hospital with Nanjing Medical University, Nanjing, Jiangsu, 025, China

Summary:
This is a prospective, single arm, single center, phase II study of NALIRIFOX as conversion therapy in patients with locally advanced pancreatic cancer.

Primary Outcome Measures: Objective response rate (ORR), ORR is defined as the percentage of participants who have a confirmed complete response or partial response according to RECIST 1.1., Up to 1 year
Secondary Outcome Measures: Progression free survival (PFS), PFS is defined as the time from enrollment of the trial to the first documented disease progression or death due to any cause., Up to two years|Overall survival (OS), The duration from the date of recruitment to the date of death from any cause., Up to two years|Adverse events (safety), Adverse events (safety ) will be evaluated according to the NCI CTCAE Version 5.0.The number and severity of treatment-related side effects, including AE and SAE, will be recorded during treatment., Up to two years
Efficacy and Safety of Hydroxychloroquine in the Treatment of Sudden Sensorineural Hearing Loss
NCT Number: NCT06467526
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Sudden Hearing Loss
Interventions: DRUG: Hydroxychloroquine|DRUG: Steroid
Sponsor: Chang Gung Memorial Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-01
Completion Date: 2027-03-31

Summary:
Sudden sensorineural hearing loss (SSNHL) is diagnosed when there's a sudden drop in hearing of at least 30 decibels across three consecutive frequencies, emerging within up to 72 hours. In clinical settings, steroids are the predominant treatment for SSNHL. However, the outcomes for patients undergoing steroid therapy for SSNHL can differ substantially. Moreover, a systematic review of randomized clinical trials has found no conclusive evidence pinpointing an effective treatment for SSNHL. Hydroxychloroquine, a derivative of chloroquine, is a medication that has gained attention for its potential role in modulating the immune response. We aim to see if hydroxychloroquine could augment hearing recovery in SSNHL under steroid treatment and to evaluate the safety of hydroxychloroquine in the treatment of SSNHL patients. We plan to enroll 80 SSNHL patients who received oral steroid therapy and randomize them into an experimental group (hydroxychloroquine with prednisolone, 40 patients) and a control group (prednisolone, 40 patients). The primary endpoint will be the change in pure tone audiogram (PTA) in the affected ear from screening until 3 months. The secondary endpoints will be the change in word recognition score and the change in bilateral tinnitus severity after treatment. Any side effects will be recorded to ensure the safety of this clinical trial.

Primary Outcome Measures: Hearing improvement, To evaluate if hydroxychloroquine could increase the hearing improvement, from screening until 3 months
Secondary Outcome Measures: Word recognition score, To evaluate if hydroxychloroquine could increase the word recognition score, from screening until 3 months|Tinnitus severity, To evaluate if hydroxychloroquine could decrease the tinnitus severity, from screening until 3 months
To Investigate the Effect of Esketamine Hydrochloride on Pulmonary Complications
NCT Number: NCT06467513
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Heart Diseases|Heart Valve Diseases
Interventions: DRUG: Esketamine hydrochloride injection
Sponsor: Zhang XIao Mei
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 102
Study Design: Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: OTHER
Start Date: 2024-01-01
Completion Date: 2025-05
Locations: Affiliated Hospital of Zunyi Medical University, Zunyi, Guizhou, 563000, China

Summary:
The objective of this study was to evaluate the effect of esketamine on intraoperative hemodynamics in patients with heart valve replacement and to mitigate postoperative pulmonary complications

Primary Outcome Measures: Pulmonary ultrasound score, The anterior axillary line, posterior axillary line and paraspinal line were used as the boundary, and each lung was divided into 3 regions: anterior chest, underarm and back. Each area was given a maximum score of 3 out of 36, with higher scores indicating worse lung condition., Baseline and day 1, day 2 and day 3 after surgery
Secondary Outcome Measures: The concentration of interleukin 6, The concentration of interleukin-6 in participants before and during surgery, as well as after surgery, can reflect the size of the inflammatory response to some extent., At baseline, before anesthesia induction, 10 minutes after insertion of tracheal catheter, 10 minutes after cardiopulmonary bypass, 10 minutes after completion of cardiopulmonary bypass, at the end of surgery, and 1 day after completion of surgery.
A Prospective, Open-label, Single-center, Single-arm Phase II Clinical Study of Cadonilimab (AK104) Combined With Monotherapy Chemotherapy in Patients With Advanced Non-small Cell Lung Cancer With Negative Driver Genes and Failed Immunotherapy
NCT Number: NCT06467500
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Non-small Cell Lung Cancer
Interventions: DRUG: Cadonilimab (AK104)
Sponsor: Xin-Hua Xu
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 48
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-03-01
Completion Date: 2026-12-30
Locations: Department of Medical Oncology, Central Hospital of Yichang City, the First Clinical Medical College of Three Gorges University, Yichang, 443002, China

Summary:
The aim of evaluating the efficacy and safety of cadonilimab combined with monotherapy chemotherapy in patients with advanced non-small cell lung cancer (NSCLC) with negative driver genes who have failed previous immunotherapy is to provide a more effective and safe treatment option for these patients.

Primary Outcome Measures: Objective Response Rate（ORR）, The objective response rate (ORR) refers to the proportion of patients whose tumor shrinks by a certain percentage (generally 30%) and maintains this reduction for a certain period of time (generally 4 weeks)., approximately 24 months
Secondary Outcome Measures: Disease Control Rate (DCR), Disease Control Rate (DCR) is defined as the proportion of patients with a cancer or tumor who experience a reduction in the size of the disease, no progression of the disease, or stable disease conditions for a specified period of time after receiving a particular treatment. This typically includes patients who achieve complete response (CR), partial response (PR), or stable disease (SD)., approximately 24 months|Duration of Response (DoR), Duration of Response (DoR), which stands for Duration of Response, refers to the length of time from the point when a subject achieves a confirmed complete response (CR) or partial response (PR) to the time when the first sign of disease progression or death due to any cause occurs., approximately 24 months|Progression-free survival (PFS), PFS was defined as the time between the date of randomization and the date of first documented disease progression or death, whichever occurs first. Disease progression was determined based on investigator assessment using response evaluation criteria In solid tumors (RECIST) v1.1., approximately 24 months|Overall Survival (OS), Overall Survival (OS) was defined as the time from the date of randomization to the date of death due to any cause.Data for participants who were not reported as dead at the time of analysis was censored at the date when they were last known to be alive., approximately 24 months|Adverse event (AE), Adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment., approximately 24 months
Electronic Health Record Strategies to Promote Diverse Participation in Research AIM 2
NCT Number: NCT06467487
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Patient Participation
Interventions: OTHER: Traditional Letter|OTHER: Direct to Patient Message|OTHER: Optimized Letter|OTHER: Direct to Patient Message - Optimized
Sponsor: Yale University
Collaborators: Food and Drug Administration (FDA)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 210000
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: OTHER
Start Date: 2024-09
Completion Date: 2027-11
Locations: Yale University, New Haven, Connecticut, 06511, United States

Summary:
Based on the outcomes of the initial study (NCT05348603), this optimization study will employ the most effective interventions (letters and messages) and distribute these communications to underrepresented minorities to further promote interest in research. Optimized language will be distributed in English, Spanish, Portuguese, Chinese, Arabic, or Haitian Creole, based on preferred language identified in the patient profile in an electronic medical records system.

Primary Outcome Measures: Number of patients who create a research profile, The outcome will be assessed by querying the patient's electronic medical record to determine whether the patient has registered in the Yale University Volunteer Database. This database is comprised of patients who agree to be contacted if there is a study at Yale that meets their interests., 12 months
Secondary Outcome Measures: Number of patients who enroll in a research study, The outcome will be assessed by querying our clinical trials management system or electronic health record system to determine if the patient has consented to participate in a research study., 12 months
Comparing Train-of-Four Recovery in the Adductor Pollicis Versus the Adductor Digiti Minimi in Elective Surgery Patients
NCT Number: NCT06467448
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Anesthesia|Neuromuscular Blockade
Interventions: DEVICE: EMG Assessement of Recovery of Neuromuscular Function
Sponsor: University of North Carolina, Chapel Hill
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06
Completion Date: 2024-10-01
Locations: University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, 27599, United States

Summary:
The train-of-four (TOF) ratio is a quantitative measure used in anesthesia to assess the degree of neuromuscular blockade induced by neuromuscular blocking agents during surgical procedures. Current American Society of Anesthesiologists guidelines recommend monitoring the TOF ratio to guide the administration and reversal of NMBAs, with a target ratio of 0.9 or higher at adductor pollicis muscle indicating adequate reversal and restoration of neuromuscular function.

This proposed study aims to observe and compare the TOF ratio between two different muscles of the hand: adductor pollicis and adductor digiti minim using anesthesia monitors on both of their arms during recovery of neuromuscular function. Surgery and anesthesia will occur per standard of care.

Primary Outcome Measures: Difference in Measured Recovery of Train of Four at Adductor Pollicis and Adductor Digiti Minimi, The train of four ratio at the digiti minimi will be recorded when the adductor pollicis ratio reads 90 percent, All assessments are intraoperative and complete in one day
Effects of Transcranial Temporal Interference Stimulation on Risky Decision-making and Impulse Control in Gambling Disorder
NCT Number: NCT06467422
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Gambling Disorder
Interventions: DEVICE: tTIS on dACC, theta frequency (5 Hz)|DEVICE: tTIS on dACC, High frequency
Sponsor: Shanghai Mental Health Center
Sex: MALE
Age: ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, CARE_PROVIDER)|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-06-20
Completion Date: 2025-06-01
Locations: Shanghai Mental Health Center, Shanghai, Shanghai, 200000, China

Summary:
The purpose of this research is to investigate the effect of transcranial temporal interference stimulation (tTIS) targeting the dorsal anterior cingulate cortex in patients with gambling disorder.

Primary Outcome Measures: Activation of dACC, Activation of dACC is measured with resting-state fMRI and task fMRI., Through the fMRI procedure|Activation of decision-making network, Activation of decision-making network is measured with resting-state fMRI and task fMRI connectivity analysis., Through the fMRI procedure|The change of impulsivity, The change of impulsivity will be measured by sequential decision-making task., Through the last 20 minutes of the fMRI session.
Secondary Outcome Measures: The change of gambling craving, Gambling craving will be measured by the gambling craving Visual Analog Scale (VAS). The total score of VAS ranged from 0 to 10, in which higher scores mean a higher level of gambling craving., 8 minutes, 16 minutes, 24 minutes, 44 minutes of the fMRI session.
Phase II Clinical Trial to Evaluate the Efficacy and Safety of LPM3480392 Injection for Moderate to Severe Pain After Orthopedic Surgery
NCT Number: NCT06467409
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Pain, Postoperative
Interventions: DRUG: Placebo|DRUG: morphine hydrochloride injection|DRUG: LPM3480392 Injection|DRUG: LPM3480392 Injection|DRUG: LPM3480392 Injection|DRUG: LPM3480392 Injection
Sponsor: Luye Pharma Group Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 150
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-01-26
Completion Date: 2025-01
Locations: Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China

Summary:
A randomized, double-blind, placebo/positive drug parallel controlled design was used to evaluate the preliminary efficacy and safety of intravenous infusion of LPM3480392 injection using different dosing regimens in subjects with moderate to severe pain after Orthopedic surgery

Primary Outcome Measures: SPID48, the Sum of Pain Intensity Differences in Pain Score from baseline Over 48 Hours, 48 hours
Secondary Outcome Measures: Cumulative dose of rescue analgesic drugs, 48 hours|Incidence of adverse events, 48 hours
Blood Biomarkers to Predict the Prognosis of a Stroke Patient Undergoing Mechanical Thrombectomy
NCT Number: NCT06467396
Acronym: TROMBOPOCT
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Acute Ischemic Stroke
Interventions: DEVICE: Large Vessel Occlusion Biomarkers Test
Sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Collaborators: Hospitales Universitarios Virgen del Rocío|Hospital Universitario Reina Sofia de Cordoba
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 400
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-04-09
Completion Date: 2025-07
Locations: Hospital Universitario Reina Sofía, Córdoba, Spain|Hospital Universitario Virgen Rocío, Sevilla, Spain

Summary:
The goal of this observational study is to evaluate the accuracy of a panel of blood biomarkers and clinical variables in predicting the prognosis of stroke patients treated by mechanical thrombectomy, specifically to predict futile recanalization and mortality.

Primary Outcome Measures: Specificity and sensibility of blood biomarkers in combination with neurological scales (NIHSS) determined before the thrombectomy intervention to predict the prognosis of the patient (functional dependence and mortality)., through the study completion, an average of one year
Secondary Outcome Measures: Percentage of patients who suffer a futile recanalization after a mechanical thrombectomy., 3 months
A Study to Describe the Diagnostic and Therapeutic Path of Patients with NSCLC in Early Stage and Locally Advanced
NCT Number: NCT06467383
Acronym: Key-Early
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Non-small Cell Lung Cancer|NSCLC|NSCLC, Stage III|NSCLC, Stage I
Sponsor: MSD Italia S.r.l.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 600
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-20
Completion Date: 2025-06-19

Summary:
This is a non-interventional, retrospective observational study to improve knowledge regarding the diagnosis and treatments of patients who have/had non-small cell lung cancer (NSCLC), either early stage (stage I-II).

Primary Outcome Measures: Percentage of patients undergoing surgery for early stage or locally advanced NSCLC, Curative surgery, defined as surgical resection of the lung cancer (i.e. lobectomy, pneumonectomy, segmental resection, or other) with curative intent, Restrospective data capture from January 2018 to January 2021.|Percentage of patients discusses in multidisciplinary team, Restrospective data capture from January 2018 to January 2021|Percentage of patient receiving neoadjuvant and/or adjuvant treatment and percentage of patient undergoing definitive (chemo)radiotherapy, Concurrent (or concomitant) chemoradiotherapy, defined as any regimen of chemotherapy administered with concurrent radiotherapy. Sequential chemoradiotherapy, defined either as any regimen of chemotherapy followed by at least one session of radiotherapy, or at least one radiotherapy course followed by at least one cycle of chemotherapy; in order to be defined as sequential chemoradiotherapy, tumor resection shall not be performed between chemotherapy and radiotherapy or vice versa., Restrospective data capture from January 2018 to January 2021.|Healthcare resource utilization and direct medical costs on different therapeutic approach, Cost of illness, defined as the total key-resources cost for each patient (i.e. visits and other physician services including surgery and radiotherapy cost, hospitalization, diagnostic procedures and tests, routine laboratory, disease assessment, administered drugs), Restrospective data capture from January 2018 to January 2021.
Does Non-Steroidal Anti-inflammatory Drugs Decrease the Quality of Pleurodesis After Mechanical Pleural Abrasion/Pleurectomy for Treatment of Pneumothorax?
NCT Number: NCT06467318
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Primary and Secondary Spontaneous Pneumothorax
Interventions: DRUG: Paracetamol|DRUG: NSAID, Paracetamol
Sponsor: Ain Shams University
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 116
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, CARE_PROVIDER)|Primary Purpose: OTHER
Start Date: 2023-09-01
Completion Date: 2024-12
Locations: Faculty of medicine, Ain shams university, Cairo, 1181, Egypt

Summary:
Investigators aim to assess if NSAIDs affect the quality of pleurodesis resulting from mechanical pleurodesis (open surgery or VATS) regarding : Primary outcome: Recurrence of pneumothorax in 6 monthes. (assessed by X ray after 2 weeks and 6 months or symptoms requiring X ray at any timing) Secondary outcome: ▪ Adjusted Length of stay ( from day zero surgery day to discharge ). ▪ Time of removal of the chest Tube .(relatively longer with air leak presence). ▪ Need of opioids (N-SAID may decrease the need of opioids) .

Primary Outcome Measures: Rate of recurrence of pneumothorax, Non-steroidal anti-inflammatory drugs (NSAIDs) are being used with increasing frequency, due to their potent analgesic effects without having side-effects on the central neural system and additionally due to the large number and varieties of these agents. The analgesic, anti inflammatory properties, and efficacy of NSAIDs in a wide variety of diseases have been already established. Wound healing and formation of adhesions involve inflammation, cell proliferation, matrix deposition, and neovascularization. The exact mechanism by which NSAIDs affect collagen deposition and the time course of the events leading to the formation of fibrin and of adhesions after pleurodesis have not been completely elucidated until now. NSAIDs can inhibit the inflammatory process and the formation of fibrosis, due to their ability to suppress prostaglandin synthesis, With in 6 months or earlier with any new symptoms.
Secondary Outcome Measures: Measuring adjusted Length of stay, from day of surgery to discharge (assessed up to 2 weeks ), Around 2 weeks
Speech Motor Learning and Retention (Aim 1)
NCT Number: NCT06467305
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Speech
Interventions: DEVICE: continuous theta-burst stimulation (cTBS)|BEHAVIORAL: Adaptation
Sponsor: Yale University
Collaborators: National Institute on Deafness and Other Communication Disorders (NIDCD)
Sex: ALL
Age: ADULT
Enrollment: 160
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-07
Completion Date: 2027-07
Locations: Yale Child Study Center, New Haven, Connecticut, 06520, United States

Summary:
The overall goal of this research is to test a new model of speech motor learning, whose central hypothesis is that learning and retention are associated with plasticity not only in motor areas of the brain but in auditory and somatosensory regions as well. The strategy for the proposed research is to identify individual brain areas that contribute causally to retention by disrupting their activity with transcranial magnetic stimulation (TMS). Investigators will also use functional magnetic resonance imaging (fMRI) which will enable identification of circuit-level activity which predicts either learning or retention of new movements, and hence test the specific contributions of candidate sensory and motor zones. In other studies, investigators will record sensory and motor evoked potentials over the course of learning to determine the temporal order in which individual sensory and cortical motor regions contribute. The goal here is to identify brain areas in which learning-related plasticity occurs first and which among these areas predict subsequent learning.

Primary Outcome Measures: Speech motor learning, Audapter software will be used to alter the first and second formant frequencies of the spoken words and this is played back to subjects through headphones. Subjects will be tested both with unaltered feedback and with abruptly introduced frequency shifts.The change in the first (F1) and second format frequency (F2) values will be assessed using Praat., Performance as measured at the end of learning (30 minute session)|Retention of learning, The retention of adaptation to altered auditory feedback (and relearning) will be quantified in terms of F1 and F2 frequency shifts (relative to pre-training baseline). Larger values indicate more complete relearning or retention., 24 hours after learning (re-test lasts 30 minutes)
Speech Motor Learning and Retention (Master Protocol)
NCT Number: NCT06467292
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Speech
Interventions: DEVICE: continuous theta-burst stimulation (cTBS)|BEHAVIORAL: Adaptation|DEVICE: Single pulse Transcranial magnetic stimulation (TMS)|DEVICE: fMRI
Sponsor: Yale University
Collaborators: National Institute on Deafness and Other Communication Disorders (NIDCD)
Sex: ALL
Age: ADULT
Enrollment: 330
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-07
Completion Date: 2027-07
Locations: Yale Child Study Center, New Haven, Connecticut, 06520, United States

Summary:
The overall goal of this research is to test a new model of speech motor learning, whose central hypothesis is that learning and retention are associated with plasticity not only in motor areas of the brain but in auditory and somatosensory regions as well.

Primary Outcome Measures: Speech motor learning, Audapter software will be used to alter the first and second formant frequencies of the spoken words and this is played back to subjects through headphones. Subjects will be tested both with unaltered feedback and with abruptly introduced frequency shifts.The change in the first (F1) and second format frequency (F2) values will be assessed using Praat., Performance as measured at the end of learning (30 minute session)|Retention of learning, The retention of adaptation to altered auditory feedback (and relearning) will be quantified in terms of F1 and F2 frequency shifts (relative to pre-training baseline). Larger values indicate more complete relearning or retention., 24 hours after learning (re-test lasts 30 minutes)
Comparing Inhalation and Total Intravenous Anesthesia Methods
NCT Number: NCT06467279
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Children|Hernia, Inguinal
Interventions: DEVICE: Target Controlled İnfusion|DRUG: Inhalation anesthetic
Sponsor: TC Erciyes University
Sex: ALL
Age: CHILD
Enrollment: 60
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-15
Completion Date: 2025-02-15
Locations: Özlem OZ GERGİN, Kayseri̇, Turkey

Summary:
comparison of Anesthesia by Target-Controlled Infusion and Inhalation Methods on Pediatric Patients Undergoing Inguinal Hernia Repair: Effects on Patient Outcomes

Primary Outcome Measures: Modified Aldrete Scoring System, The effects on recovery were monitored within the first hour of the postoperative period using the Modified Aldrete Scoring System (MASS). Totally 0-10 points can be given by MASS. Higher scores predicts better recovery., after surgery 1 hours
Secondary Outcome Measures: blood pressure (mmHg), The blood pressure of the patients will be measured and recorded in mmHg at five-minute intervals from the beginning until the first postoperative hour., after surgery 1 hours|heart rate (Beats/minute), The heart rate of the patients will be measured and recorded in mmHg at five-minute intervals from the beginning until the first postoperative hour., after surgery 1 hours