pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Neoadjuvant Intra-tumor Double Immunotherapy for Hepatocellular Carcinoma.
NCT Number: NCT06492408
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Hepatic Cancer|Surgery
Interventions: DRUG: ipilimumab, pembrolizumab, durvalumab, idarubicin, bevacizumab
Sponsor: Second Affiliated Hospital of Guangzhou Medical University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 90
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-01
Completion Date: 2033-12-30
Locations: The Second Affiliated Hospital of Guangzhou Medical University, Guanzhou, Guangdong, 51260, China

Summary:
This trial is designed to investigate the safety, response rates and survival outcomes of patients with hepatocellular carcinoma by delivery of CTLA4 and PD1 or PDL1 antibodies combination through CT-guided intra-tumor (IT) injection.

Primary Outcome Measures: pCR rate for the study groups, Pathologic complete response (pCR) is defined as after neoadjuvant therapy, the surgical specimen can not find any residual cancer cells., Six months|mPR rate for the study groups, Major pathologic response (MPR) is defined as pathological less than 10% survival cancer cells after tumor resection., Six months
Secondary Outcome Measures: Toxicity of the study groups, Toxicity is assessed by the National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE\] version 4., Six months|Response rates to neoadjuvant treatment, Response rates are assessed by Response Evaluation Criteria in Solid Tumors \[RECIST\] version 1.1., Six years|Recurrence-free survival, Recurrence-free survival is measured as routine., Six years|Overall survival, To correlate major pathologic response with recurrence-free and overall survival., Six years
Lenvatinib Plus DEB-TACE and HAIC vs. Lenvatinib Plus DEB-TACE for Large HCC With PVTT
NCT Number: NCT06492395
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Hepatocellular Carcinoma Non-resectable
Interventions: COMBINATION_PRODUCT: Len+DEB-TACE+HAIC|COMBINATION_PRODUCT: Len+DEB-TACE
Sponsor: Second Affiliated Hospital of Guangzhou Medical University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 178
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2027-07-31
Locations: The Second Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, 510260, China

Summary:
This study is conducted to evaluate the efficacy and safety of lenvatinib plus transarterial chemoembolization (TACE) with drug-eluting beads (DEB-TACE) and hepatic artery infusion chemotherapy (HAIC) with FOLFOX regemen (Len+DEB-TACE+HAIC) versus lenvatinib plus DEB-TACE (Len+DEB-TACE) for large hepatocellular carcinoma (\> 7cm) with portal vein tumor thrombosis (PVTT).

Primary Outcome Measures: Time to progression (TTP), The time from date of randomization until the first occurrence of disease progression (according to mRECIST)., 2 years
Secondary Outcome Measures: Objective response rate (ORR), The proportion of patients with the best response of complete response (CR) or partial response (PR) according to mRECIST., 2 years|Disease control rate (DCR), The proportion of patients with the best response of CR, PR, or stable disease (SD) according to mRECIST., 2 years|Overall survival (OS), The time from date of randomization to death due to any cause., 3 years|Adverse Events (AEs), Number of patients with AEs assessed by Common Terminology Criteria for Adverse Events v5.0., 3 years.
The Effects of Home Monitors Used With Home Oxygen Therapy
NCT Number: NCT06492382
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Frequency of Adverse Events, Health Care Utilization, Infant Growth, Parental Quality of Life, and Altitude of the Participant's Home
Interventions: DIAGNOSTIC_TEST: Home Oxygen Monitors
Sponsor: University of New Mexico
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-08-08
Completion Date: 2026-03-01

Summary:
This study\&#39;s purpose is to determine the effects of using monitors with home oxygen therapy (HOT). This trial will test the hypothesis that infants discharged from the neonatal intensive care unit (NICU) with HOT will have a shorter treatment duration if used in conjunction with monitors.

Primary Outcome Measures: Oxygen Wean, Length of time it takes infant to get off home oxygen, 1 -2 months
MAFLD Fibrosis Score for Detecting Fibrotic NASH in MAFLD Egyptian Patients
NCT Number: NCT06492369
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Metabolic- Associated Fatty Liver Disease (MAFLD)
Sponsor: Tanta University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 380
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-03-15
Completion Date: 2024-11-30
Locations: Tropical medicine department, Tanta University Hospitals, Tanta, Gharbyea, 31527, Egypt

Summary:
Metabolic-associated fatty liver disease (MAFLD), is a metabolic stress-induced liver injury characterized by diffuse hepatocyte macrovesicular fatty infiltration.

The incidence of MAFLD is increasing yearly, and its incidence rate is as high as 20% to 30% on a global scale, which seriously affects people's health. Non-alcoholic steatohepatitis (NASH), a chronic hepatitis that can progress to advanced fibrosis, decompensated cirrhosis, and hepatocellular carcinoma, affects one-fifth of NAFLD patients. Depending on the histological severity of fibrosis, patients with NASH can be further classified as early NASH (F0-F1 fibrosis), fibrotic NASH (≥F2 fibrosis), or NASH-cirrhosis (F4 fibrosis).

Identifying subjects with fibrotic NASH is essential as they are at risk of complications, and disease progression and may benefit from potential pharmacological therapy.

Assessment of fibrotic NASH ranges from noninvasive scores to percutaneous liver biopsy, but liver biopsy is invasive and limited by cost, sampling variability, and intrareader/interreader variability.

Noninvasive modalities to risk stratify fibrotic NASH include serum biomarkers, imaging, and algorithms combining both. The FibroScan-AST (FAST) composite score is based on the liver stiffness measure (LSM), controlled attenuation potential (CAP), and AST. At the cut-off of a FAST score ≥0.67, biopsy-proven fibrotic NASH (NAFLD with a histological NAFLD activity score \[NAS\] ≥4 and fibrosis ≥2) can be ruled in with 90% specificity.

A new predictive model was recently developed based on eight variables (age, BMI, HbA1c, history of type 2 diabetes, International normalized ratio (INR), AST, Gamma Glutamyl transferase (GGT), and platelet count). A composite score MAFLD Fibrosis Score (MFS) was calculated as: MFS = 0.078 × Age (year)-0.007363 × Platelet count (109/L) + 0.0146 × AST (U/L) + 0.007618 × GGT (U/L) + 6.673 × INR + 0.09833 × BMI (kg/m2) + 1.425 × type 2 diabetes (yes = 1, no = 0).

So, in this study, the investigators will try to evaluate the accuracy of the new emerging predictor MAFLD Fibrosis Score (MFS) vs AST- to-platelet ratio index (APRI) score, fibrosis-4 index (FIB-4) score, and NAFLD fibrosis score in the assessment of the fibrotic NASH in Egyptian NAFLD patients.

Primary Outcome Measures: Accuracy of MFS in detecting Fibrotic NASH, evaluation of accuracy of MAFLD Fibrosis Score (MFS) in the assessment of the fibrotic NASH in Egyptian patients., till August 2024
Impact of Tripolar Radiofrequency on Acne Scar
NCT Number: NCT06492356
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Acne Scars - Mixed Atrophic and Hypertrophic|Scar|Radiofrequency
Interventions: DEVICE: Tripolar radiofrequency therapy|DRUG: medical treatment
Sponsor: Cairo University
Sex: ALL
Age: ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2023-07-01
Completion Date: 2024-06-01
Locations: Malawy Specialized Hospital, Minya, Egypt

Summary:
The aim of this study is to investigate the therapeutic efficacy of tripolar radiofrequency on acne scar

Primary Outcome Measures: Assessing the change in severity of acne scars, SCARS is a 5-item instrument designed to rate the severity of acne scars in a mirror. It uses visual analog scales to differentiate between active and scars. The tool is self-completion and can be completed quickly. Patients are photographed at the beginning and after 12 treatment sessions. SCARS scores range from 0 to 4, with higher scores indicating greater severity. It captures demographic information and clinical characteristics of acne and scarring., at base line and following 12 weeks
Secondary Outcome Measures: Assessing the quantitative measurement of the acne scars, Dey et al. developed an automatic approach to quantify acne scars using color images, achieving a sensitivity of 90.36 and specificity of 93.82. However, this method does not allow for volumetric assessment of the scar. Another technique, proposed by Petukhova et al., uses three-dimensional photographic images to construct a topographic map, which is then objectively calculated for each scar. This method does not assess color changes like dyspigmentation, which is essential for tracking scars over time. Further testing is needed to improve this method., at base line and following 12 weeks
Neurofeedback in Clinical High Risk
NCT Number: NCT06492343
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Real Neurofeedback From DMN|Sham Neurofeedback From Motor Cortex
Interventions: OTHER: fMRI based neurofeedback
Sponsor: Boston VA Research Institute, Inc.
Sex: ALL
Age: CHILD, ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-09
Completion Date: 2028-12

Summary:
The goal of this trial is to test whether fMRI based neurofeedback from default mode network (DMN) will reduce DMN hyperconnectivity in clinical high risk individuals, which will lead to reductions in clinical symptoms and improve cognitive performance.

Primary Outcome Measures: rs-FMRI DMN changes, post-NFB, reductions in resting state functional connectivity MPFC-PPC in real NFB group only, three weeks|rs fMRI MPFC-STG changes, post-NFB, reductions in MPFC-PCC resting state functional connectivity, post NFB, in real NFB group only, three weeks
Secondary Outcome Measures: GABA in MPFC, GABA levels at baseline in MPFC, one week
RC48 Plus AK104 as First-line Treatment for HER2-overexpressing Advanced Gastric Cancer
NCT Number: NCT06492317
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: HER2-positive Gastric Cancer
Interventions: DRUG: Disitamab Vedotin|DRUG: Cadonilimab
Sponsor: The First Affiliated Hospital of Zhengzhou University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-06
Completion Date: 2027-07-06
Locations: The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, 450052, China

Summary:
A single-arm, single-center phase II trial study to assess the efficacy and safety of disitamab vedotin plus cadonilimab as first-line therapy for HER2-overexpressing advanced stomach carcinoma

Primary Outcome Measures: objective response rate (ORR), The proportion of subjects with complete response (CR) and partial response (PR) in total subjects, 6 months after the last subject participating in
Secondary Outcome Measures: duration of response (DOR), DOR (per RECIST 1.1) is defined as the time from the date for first documented response of complete response (CR) or partial response (PR) to the date of first documented of disease progression or death, whichever occurs first., 12 months after the last subject participating in|disease control rate (DCR), The proportion of subjects with complete response (CR) and partial response (PR) and stable disease (SD) in total subjects, 12 months after the last subject participating in|time to response (TTR), TTR (per RECIST 1.1) is defined as the time from the starting date of study drug to the first time complete response (CR) or partial response (PR), 12 months after the last subject participating in|progression-free survival (PFS), Progression-free survival (PFS per RECIST 1.1) is defined as the time from the starting date of study drug to the date of first documentation of disease progression or death, whichever occurs first, 12 months after the last subject participating in|overall survival (OS), Progression-free survival (PFS per RECIST 1.1) is defined as the time from the starting date of study drug to the date of first documentation of disease progression or death, whichever occurs first, 12 months after the last subject participating in
A Safety and Efficacy Study Evaluating CTX131 in Adult Subjects With Relapsed/Refractory Hematologic Malignancies
NCT Number: NCT06492304
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: T Cell Lymphoma|B Cell Lymphoma|Acute Myeloid Leukemia
Interventions: BIOLOGICAL: CTX131
Sponsor: CRISPR Therapeutics
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 290
Study Design: Allocation: NA|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-13
Completion Date: 2030-11
Locations: Research Site 6, Phoenix, Arizona, 85054, United States|Research 2, Stanford, California, 94305, United States|Research Site 3, Boston, Massachusetts, 02114, United States|Research Site 5, Bronx, New York, 10467, United States|Research Site 4, New York, New York, 10065, United States|Research Site 1, Houston, Texas, 77030, United States

Summary:
This is an open label, multicenter, phase 1/2 dose evaluation and cohort expansion study evaluating the safety and efficacy of CTX131 in subjects with Relapsed/Refractory Hematologic Malignancies

Primary Outcome Measures: Phase 1 Part A (dose escalation) and Part B (dose optimization in selected disease types):, For all cohorts: Incidence of Adverse events defined as as dose-limiting toxicities, From CTX131 infusion up to 28 days post-infusion|Objective Response rate (ORR), Phase 2 (expansion of selected Phase 1 disease types), From CTX131 infusion up to 60 months post-infusion|Composite Complete Remission (CRc), Phase 2 (expansion of selected Phase 1 disease types), From CTX131 infusion up to 60 months post-infusion
Resiliency Programming for Caregivers of Children With Learning and Attentional Difficulties
NCT Number: NCT06492278
Acronym: SPARK
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Parenting|Stress|Learning Disabilities, Child|Attention Difficulties
Interventions: BEHAVIORAL: SMART-3RP|BEHAVIORAL: Health Education Program
Sponsor: Massachusetts General Hospital
Collaborators: National Center for Complementary and Integrative Health (NCCIH)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2026-08

Summary:
This is a randomized open pilot trial enrolling up to 40 co-primary caregivers of children with LAD. Participants will be randomized to receive either mind-body resiliency group (SMART-LAD, intervention) or an evidence-based group intervention Health Education Program (HEP, control) which is a multiple behavior change program that addresses sleep, exercise, nutrition, substance use, and working with one's healthcare team. Both the SMART-3RP and HEP programs have been modified based on adaptions from our previous qualitative study.

Primary Outcome Measures: Feasibility of the refined interventions (SMART-3RP and HEP), The key feasibility metrics include program engagement, quantified as participant rates of intervention attendance, as well as rates of participant recruitment and enrollment. Given the preliminary, open pilot nature of this protocol, the investigators will not set a priori criteria to establish feasibility but will rather use these data to inform ongoing protocol refinement., Approximately 3 months (approximately 8-10 weeks after intervention start)|Acceptability of the refined interventions (SMART-3RP and HEP), The key intervention acceptability metrics include participant ratings of overall comfort with the group program as well as perceived group cohesiveness. Given the preliminary, open pilot nature of this protocol, the investigators will not set a priori criteria to establish acceptability but will rather use these data to inform ongoing protocol refinement., Approximately 3 months (approximately 8-10 weeks after intervention start)
Study to Demonstrate Pharmacokinetic and Pharmacodynamic Similarity Between NKF-INS(A), US-NovoLog®, and EU-NovoRapid®
NCT Number: NCT06492226
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Healthy Participants
Interventions: DRUG: NKF-INS(A)|DRUG: EU-NovoRapid®|DRUG: US-NovoLog®
Sponsor: Xentria, Inc.
Sex: MALE
Age: ADULT
Enrollment: 54
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: OTHER
Start Date: 2024-07-30
Completion Date: 2024-11
Locations: Xentria Investigative Site, Bloemfontein, 9301, South Africa

Summary:
Single-dose, double-blind, randomized, three-period, three-treatment, six-sequence, crossover study to demonstrate pharmacokinetic and pharmacodynamic similarity between NKF-INS(A), US-NovoLog®, and EU-NovoRapid®

Primary Outcome Measures: To compare the PK of NKF-INS(A) to US-approved and EU-authorized insulin aspart to demonstrate PK similarity for insulin aspart., Aspart concentration-time curve from 0 to 12 hours (AUC0-t)., Day 1 for 12 Hours|To compare the PK of NKF-INS(A) to US-approved and EU-authorized insulin aspart to demonstrate PK similarity for insulin aspart., Maximum observed insulin aspart concentration (Cmax), Day 1 for 12 Hours|To compare the PD of NKF-INS(A) to US-approved and EU-authorized insulin aspart injection by examining GIR profiles after a single SC dose., Area under the GIR-time curve from 0 to 12 hours (AUCGIR0-t)., Day 1 for 12 Hours|To compare the PD of NKF-INS(A) to US-approved and EU-authorized insulin aspart injection by examining GIR profiles after a single SC dose., Maximum GIR (GIRmax) of glucose, Day 1 for 12 Hours
Secondary Outcome Measures: To evaluate additional PK parameters of NKF-INS(A) compared to US-approved and EU-authorized insulin aspart., PK parameters for serum insulin aspart concentrations: AUC0-4h, AUC0-6h, AUC6-12h, AUC0-12h, Tmax, AUC0-∞, Day 1 for 12 Hours|To evaluate additional PK parameters of NKF-INS(A) compared to US-approved and EU-authorized insulin aspart., Time to half-maximum before Cmax (t50%-early), Day 1 for 12 Hours|To evaluate additional PK parameters of NKF-INS(A) compared to US-approved and EU-authorized insulin aspart., Time to half-maximum after Cmax (t50%-late), Day 1 for 12 Hours|To evaluate additional PK parameters of NKF-INS(A) compared to US-approved and EU-authorized insulin aspart., The terminal elimination half-life (t1/2), Day 1 for 12 Hours
The Efficacy and Safety of Pulsed Radiofrequency Combined With Platelet-rich Plasma for Infraorbital Neuralgia
NCT Number: NCT06492213
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Infraorbital Neuralgia|Platelet-rich Plasma
Interventions: OTHER: No interventions
Sponsor: Beijing Tiantan Hospital
Collaborators: Wuhan Union Hospital, China|Qinghai People's Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 240
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-01
Completion Date: 2027-07-31

Summary:
This is a multicenter, prospective, observational, propensity score matching, cohort, and assessor-blinded study designed to compare the effectiveness and safety of PRP injections combined with PRF treatment with PRF alone in patients with IONa who are responded poorly to conventional therapies and are reluctant to receive destructive therapies for seeking a better minimally invasive treatment strategy.

Primary Outcome Measures: The 1-year response rate, cases responding to treatment/total number of cases\*100%, 12-month period
Secondary Outcome Measures: Response rate, cases responding to treatment/total number of cases\*100%, at 1 day, 1 week, 1 month, 3 months, 6 months, 9 months, 12 months after operation|Dosage of carbamazepine, dosage of carbamazepine, at 1 day, 1 week, 1 month, 3 months, 6 months, 9 months, 12 months after operation|Numeric rating scale (NRS) score of pain, 0 representing no pain and 10 representing the most severe pain imaginable, at 1 day, 1 week, 1 month, 3 months, 6 months, 9 months, 12 months after operation|Patients' quality of life (QOL), evaluated by 12-item short-form health survey (SF-12) scores,Response categories vary from 2 to 6 and can be transformed to scale scores ranging from 0 ('the worst') to 100 ('the best'), at 1 day, 1 week, 1 month, 3 months, 6 months, 9 months, 12 months after operation|Patient satisfaction scores (PSS）, 0 point indicates unsatisfactory, while 10 points indicate the most satisfactory, at 1 day, 1 week, 1 month, 3 months, 6 months, 9 months, 12 months after operation|Adverse events (AEs), such as dizziness, facial swelling, facial ecchymoma, eye injury, infection, etc, at 30minutes, 1 day, 1 week, 1 month, 3 months, 6 months, 9 months, 12 months after treatment.
Triage Survey for Infectious Disease Eligibility
NCT Number: NCT06492187
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Vaccination; Infection|HIV-1-infection|Infectious Disease
Sponsor: Brooklyn Clinical Research
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 10000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-28
Completion Date: 2029-01-28
Locations: Brooklyn Clinical Research, Brooklyn, New York, 11226, United States

Summary:
SWIFT-ID-101 is a single site survey study designed to assess potential participants' eligibility to screen for industry-sponsored clinical trials for diagnosis, treatment, or prevention of infectious diseases such as in the areas of HIV, vaccines, and other infectious-diseases areas. A physician will oversee the informed consent process, after which participants will be surveyed on demographics, medical/surgical history, physical examination, comorbidities, and any current symptoms. Informed consent will be done electronically (preferable) or on paper. Informed consent may be done in-person or remotely, depending on patient preference. Information related to HIV, hepatitis B and C, other infectious diseases, or substance use disorder will also be obtained if applicable. Site staff may collect vital signs, fingerpick testing, urine drug screens, blood draws, EKG, and pregnancy tests. Some testing may be recommended in a fasting condition. A doctor will review medical history and results of the above evaluations with the participant to determine study suitability via clinical interview. The doctor may reach out to the patient's current treating physicians, other providers, and pharmacies to determine eligibility for clinical trials. A follow-up phone call may be needed to discuss testing results and/or trial eligibility. If a participant is deemed eligible for future trials and if the participant remains interested, counseling on contraception requirements for trials will be discussed.

Primary Outcome Measures: Number of participants interested in clinical research, Number of participants for whom an industry-sponsored clinical research clinical research is clinically appropriate for HIV, vaccines, and other infectious diseases, 5 years
Secondary Outcome Measures: Clinical Trial Enrollment, Proportion of the clinical trial seeking population who enroll in industry-sponsored studies in infectious diseases therapeutic area., 5 years
Other Outcome Measures: Disqualifying conditions, Prevalence of disqualifying comorbid conditions that prevent screening or enrollment in industry-sponsored clinical research for HIV, vaccines, and other infectious diseases., 5 years
A Clinical Trial to Assess the Agent Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis (ISR) - Long Lesion Cohort
NCT Number: NCT06492174
Acronym: AGENT IDE
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: In-Stent Restenosis
Interventions: DEVICE: AGENT DCB 40 mm
Sponsor: Boston Scientific Corporation
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2027-10
Locations: Carondelet Medical Group St. Mary's Hospital, Tucson, Arizona, 85745, United States|Emory University Hospital, Atlanta, Georgia, 30322, United States|Northside Hospital, Lawrenceville, Georgia, 30046, United States|Wellstar Kennestone Hospital, Marietta, Georgia, 30060, United States|Beth Israel Deaconess Medical Center, Boston, Massachusetts, 02215, United States|Henry Ford Hospital, Detroit, Michigan, 48202, United States|St. Francis Hospital, Roslyn, New York, 11576, United States|Lindner Center for Research and Education at Christ Hospital, Cincinnati, Ohio, 45219, United States|UPMC Pinnacle Health, Wormleysburg, Pennsylvania, 17053, United States|Rhode Island Hospital, Providence, Rhode Island, 02903, United States|Centennial Medical Center, Nashville, Tennessee, 37203, United States|University of Washington, Seattle, Washington, 98195, United States

Summary:
The purpose of the AGENT IDE study is to assess the safety and effectiveness of the Agent Paclitaxel Coated PTCA Balloon Catheter in patients with in-stent restenosis (ISR) of a previously treated lesion of up to 36 mm in length (by visual estimate) in a native coronary artery 2.0 mm to 4.0 mm in diameter.

Primary Outcome Measures: Number of Participants With Target Lesion Failure, The primary endpoint is the 12-month Target Lesion Failure (TLF) rate, defined as any ischemia-driven revascularization of the target lesion (TLR), myocardial infarction (MI, Q-wave and non-Q-wave) related to the target vessel, or cardiac death, 12-month
A Study in Chinese People With Overweight or Obesity to Test How Different Doses of Survodutide Are Taken up in the Body
NCT Number: NCT06492135
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Overweight|Obesity
Interventions: DRUG: survodutide
Sponsor: Boehringer Ingelheim
Sex: ALL
Age: ADULT
Enrollment: 30
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-15
Completion Date: 2025-06-24
Locations: Shanghai Central Hospital of Xuhui District, Shanghai, 200031, China

Summary:
This study is open to Chinese adults aged 18 to 60 with overweight or obesity. People can join the study if they have a Body Mass Index from 24 to 40.0 kg/m2.

Survodutide is a medicine being developed to help people with overweight or obesity. The purpose of this study is to find out how different doses of survodutide are taken up in the body. Other goals are to test if participants can tolerate different doses of survodutide and whether survodutide helps people with overweight or obesity.

Participants receive survodutide as an injection under the skin once a week for 7.5 months. During this time, participants visit the study site 33 times. 4 of the visits require a stay in the hospital. At the visits, doctors take blood samples to measure the levels of survodutide in participants' blood. The doctors also check participants' health and take note of any unwanted effects.

Primary Outcome Measures: AUC0-168 (area under the concentration-time curve of survodutide in plasma over the time interval from 0 to 168h), up to 7 days|Cmax (maximum measured concentration of survodutide in plasma) after the first dose, up to 7 days|Cmax (maximum measured concentration of survodutide in plasma) after multiple doses, up to 7 days
Secondary Outcome Measures: Percentage (%) of participants withdrawn due to adverse events from up-titration by dose, up to 7 days
Study With [225Ac]Ac-FL-020 in mCRPC Participants
NCT Number: NCT06492122
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Metastatic Castration-resistant Prostate Cancer
Interventions: DRUG: [225Ac]Ac-FL-020|DRUG: Blood samples for PK|DRUG: [111In]In-FL-020|PROCEDURE: Blood and urine samples collection|PROCEDURE: SPECT/CT images
Sponsor: Full-Life Technologies GmbH
Sex: MALE
Age: ADULT, OLDER_ADULT
Enrollment: 35
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07
Completion Date: 2026-12

Summary:
The purpose of this study is to evaluate the safety, therapeutic effect, and pharmacokinetics of \[225Ac\]Ac-FL-020 in participants with metastatic castration-resistant prostate cancer (mCRPC).

Primary Outcome Measures: Dose escalation: Incidence of Dose-Limiting Toxicities (DLTs)., RP2D, 28 days after the first injection of [225Ac]Ac-FL-020|Dose escalation and dose expansion: Type, frequency and severity of adverse events (AEs) and serious adverse events (SAEs) using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0., From ICF signature and up to 42 days after the last dose of study treatment and then during the long-term follow-up period
Secondary Outcome Measures: Dose escalation and dose expansion: Absorbed doses, Absorbed doses in different organs and tumors, During one week following the injection of [111In]In-FL-020|Peak Plasma Concentration (Cmax), Pharmacokinetics, During one week following the first injection of [225Ac]Ac-FL-020|Area Under the Plasma concentration versus time curve, Pharmacokinetics, During one week following the first injection of [225Ac]Ac-FL-020|Overall response rate, Anti-tumor activity via imaging assessments and PSA levels, 2 years|Disease Control Rate, Anti-tumor activity via imaging assessments and PSA levels, 2 years|Best Overall response, Anti-tumor activity via imaging assessments and PSA levels, 2 years|Progression Free Survival, Anti-tumor activity via imaging assessments and PSA levels, 2 years|Overall Survival, Anti-tumor activity, 2 years
Bibloc Mandibular Advancement Oral Device and Its Effect on TMJ Health
NCT Number: NCT06492096
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Obstructive Sleep Apnea of Adult
Interventions: DEVICE: Bibloc Mandibular Advancement device
Sponsor: Mansoura University
Sex: ALL
Age: ADULT
Enrollment: 66
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2022-06-15
Completion Date: 2024-05-30
Locations: Faculty of dentistry, Mansoura university, Al Manşūrah, Ad Dakahlia, 35511, Egypt

Summary:
The goal of this clinical trial is to learn if Mandibular Advancement Device( MAD) works to treat Obstructive sleep apnea in adults. It will also learn about the effect of the device on the Tempromandibular Joint Health . The main questions it aims to answer are:

Does MAD lower the number of apnoea and hypopnea participants suffer from during sleep? Would it cause any effect on TMJ health? Researchers will compare between a group of TMD patients with OSA to a non_TMD group of patients also with sleep apnea and both groups will receive a Bibloc MADplacebo (a look-alike substance that contains no drug) to see if it affect the TMJ health.

Participants will:

Wear MAD during sleep (at least 6 hours) every day for 6 months Visit the clinic once after the first week for checkups and adjustment of MAD If needed and then after 3 months and 6 months.

Polysomnography, MRI, and tmd screening was done before the appliance insertion and after 6 months of its insertion.

Primary Outcome Measures: Apnea/Hypopnea index, Number of apnea and hypopnea per hour of sleep, 6 months
Secondary Outcome Measures: Condylar disc position, It appears in MRI and measured before and after the appliance insertion, 6 months|Joint space of TMJ, measurement of joint space was done for each patient on their MRI before and after the treatment, 6 months
A Stuty on the Treatment and Nursing Care of CIPN Patients With Traditional Chinese Medicine Hot Package
NCT Number: NCT06492083
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Chemotherapy
Interventions: OTHER: traditional Chinese medicine hot bag
Sponsor: The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 90
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, CARE_PROVIDER)|Primary Purpose: OTHER
Start Date: 2024-10-30
Completion Date: 2025-10-30

Summary:
The combination of platinum and taxane drugs has a chemotherapy-induced peripheral neuropathy (CIPN) rate of 73% to 83%. Its symptoms can not only limit daily activities and cause a variety of accidental injuries, but also easily cause negative emotions and seriously affect the quality of life. Modern Western medicine lacks effective clinical intervention methods, and the treatment of acupuncture points with traditional Chinese medicine is simple to operate, easy to observe adverse reactions, and is suitable for continuous self-treatment outside the hospital after training, saving patients time to travel to and from the hospital, and high patient acceptance. Due to the similarity of the pathogenesis of some traditional Chinese and Western medicine in CIPN and the effectiveness of its application in patients with DPN, this study evaluated the effect of specific formulations of Chinese medicine on CIPN by comparing the degree of nerve damage between the following formulations of Chinese medicine hot packs in patients with platinum combined with paclitaxel chemotherapy and the control group.

Primary Outcome Measures: Sensory neuropathy, National Cancer Institute-Common Terminology Criteria for Adverse Events. Scoring form 1 to 5 degree., 6 months|Motor neuropathy Motor neuropathy, National Cancer Institute-Common Terminology Criteria for Adverse Events. Scoring from 1 to 5 degree., 6 months
Secondary Outcome Measures: Numbness, tingling sensation or comfortlessness in the limbs, Functional assessment of cancer therapy /gynaecologic oncology group-neuro-toxicity.Scoring from 0 to 4., 6 months|Joint muscle pain, Functional assessment of cancer therapy /gynaecologic oncology group-neuro-toxicity.Scoring from 0 to 4., 6 months|Hearing difficulties Hearing difficulties or tinnitus, Functional assessment of cancer therapy /gynaecologic oncology group-neuro-toxicity.Scoring from 0 to 4., 6 months|Pace impairment, Functional assessment of cancer therapy /gynaecologic oncology group-neuro-toxicity.Scoring from 0 to 4., 6 months|Sense of small objects, Functional assessment of cancer therapy /gynaecologic oncology group-neuro-toxicity.Scoring from 0 to 4., 6 months
Observational Study of the Use of Extraneal in Peritoneal Dialysis in Patients
NCT Number: NCT06492031
Acronym: oSCAR
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Chronic Renal Failure
Interventions: DRUG: Icodextrin Peritoneal Dialysis Solution|DRUG: Glucose Peritoneal Dialysis Solution
Sponsor: Baxter Healthcare Corporation
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 889
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-28
Completion Date: 2026-03
Locations: Baxter Investigational Site, Beijing, 100000, China|Baxter Investigational Site, Hangzhou, 310007, China|Baxter Investigational Site, Hohhot, 010000, China|Baxter Investigational Site, Jiangse, 210008, China|Baxter Investigational Site, Jiangse, 214023, China|Baxter Investigational Site, Jiangse, 215300, China|Baxter Investigational Site, Ningbo, 315000, China|Baxter Investigational Site, Shanghai, 200080, China|Baxter Investigational Site, Shanghai, 200120, China|Baxter Investigational Site, Suzhou, 215004, China

Summary:
The purpose of this study is to evaluate the effectiveness and safety of icodextrin and glucose peritoneal dialysis (PD) solutions for the long dwell exchange in PD patients with continuous ambulatory peritoneal dialysis (CAPD), and to describe medical resource utilization in patients with PD on icodextrin.

Primary Outcome Measures: Comparison of the incidence of a composite endpoint for technique failure and death, Technique failure is defined as:

* Treatment transferred from PD to HD/PHD \> 30 days; or
* PHD defines as adding HD treatment at least once every 2 weeks in 30 days during PD,

Death is specified as deaths during PD or deaths within 30 days with treatment from PD to HD/PHD, 12 months
Secondary Outcome Measures: Comparison of the proportion of patients with technique failure, Number and proportion of patients with technique failure, 12 months|Comparison of the incidence of cardiovascular events, Cardiovascular events include acute myocardial infarction, sudden severe arrhythmia ( a trial fibrillation and arrhythmia requiring hospitalization or medication), hospitalization for heart failure, stroke, and cardiovascular death., 12 months|Comparison of the incidence of the changes in ejection fraction, Change of the echocardiographic values from baseline: left ventricular ejection fraction fraction (LVEF）, 12 months|Comparison of all-cause deaths, All-cause deaths refer to the total number of deaths from any cause within the study timeframe, 12 months|Comparison of medical resource utilization in terms of hospitalizations, Excluding hospitalizations due to medicare payments or other non-medical issues. For ICO group only, 12 months|Comparison of annual exchange dosage of ICO, For ICO group only, 12 months
A Clinical Study of 9MW2821 (and PD-1 Inhibitor) in Locally Advanced or Metastatic Triple-Negative Breast Cancer
NCT Number: NCT06492005
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Triple-Negative Breast Cancer
Interventions: DRUG: 9MW2821|DRUG: PD-1 inhibitior
Sponsor: Mabwell (Shanghai) Bioscience Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 160
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07
Completion Date: 2027-07

Summary:
This study is a Phase 2, open-label,multicenter study designed to evaluate the efficacy and safety of 9MW2821monotherapy or combined with PD-1 inhibitor in locally advanced or metastatic Triple-Negative Breast Cancer.

Primary Outcome Measures: Objective Response Rate, ORR, Up to 24 months
Secondary Outcome Measures: Duration of Response, DoR, Up to 24 months|Time to Response, TTR, Up to 24 months|Disease Control Rate, DCR, Up to 24 months|Progression Free Survival, PFS, Up to 24 months|Overall Survival, OS, Up to 24 months|Pharmacokinetic parameter：total antibody (TAb), antibody drug conjugate (ADC), and Monomethyl Auristatin E (MMAE), Maximum observed concentration (Cmax), 24 months|Pharmacokinetic parameter：total antibody (TAb), antibody drug conjugate (ADC), and Monomethyl Auristatin E (MMAE), Area under the concentration-time curve (AUC), 24 months|Pharmacokinetic parameter：total antibody (TAb), antibody drug conjugate (ADC), and Monomethyl Auristatin E (MMAE), Half-life (t1/2), 24 months|Pharmacokinetic parameter：total antibody (TAb), antibody drug conjugate (ADC), and Monomethyl Auristatin E (MMAE), Clearance (CL), 24 months|Incidence of Anti-Drug Antibody (ADA), ADA, Up to 24 months
Chitosan Phonophresis on Cervical IN Smartphone Addicted Users
NCT Number: NCT06491992
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cervical Pain
Interventions: DRUG: Chitosan Phonophresis|OTHER: selected physical therapy exercise
Sponsor: October 6 University
Sex: ALL
Age: CHILD, ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-01
Completion Date: 2024-10-15
Locations: Lama S Mahmoud, Al Jīzah, Select State, Egypt

Summary:
A phonophoresis-based drug delivery system is a synchronous approach to improve local drug penetration in neuromuscular diseases associated with neuronal damage, excruciating pain, and local inflammation. Chitosan, a semi-synthetic material, is obtained by partial deacetylation of chitin amines, resulting in copolymers of N-acetylglucosamine and N-glucosamine. Its use has been explored in various biomaterial and medical applications. Chitosan has emerged as a cost-effective, biocompatible, and biodegradable material with many desirable biological properties, improvement of homeostasis and antiviral potential. Chitosan was found to suppress pro-inflammatory cytokines and decreased peripheral nerve edema, the polycationic nature of chitosan allows it to absorb protons, which reduces inflammation and provides an analgesic effect.

Primary Outcome Measures: Smartphone Addiction Scale-Short Version (SAS-SV), SAS-SV was psychometrically robust in measuring the severity of smartphone addiction, four weeks|The visual analogue scale, was utilized to evaluate pre- and post-treatment neck pain, four weeks|Neck disability index, assess how neck pain and other symptoms manifested during various functional activities. Ndi had been reported as a reliable (Cronbach's alpha: 0.89) and valid instrument to evaluate self-rated disability in patients with neck pain, four weeks
Secondary Outcome Measures: Cervical ROM, Cervical active ROM will be measured for each participant in the study by digital goniometer device., four weeks
Clinical Outcomes and Inflammatory Responses in Viral vs. Bacterial Sepsis
NCT Number: NCT06491966
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Sepsis|Sepsis Bacterial|Viral Sepsis|Inflammatory Response|Cytokine Storm|COVID-19|MODS
Interventions: OTHER: observation
Sponsor: Sichuan Provincial People's Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 300
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-04-02
Completion Date: 2024-07-10
Locations: Sichuan Provincial People's Hospital, Chengdu, Sichuan, 610091, China

Summary:
This observational cohort study aims to compare clinical outcomes and inflammatory responses between patients with viral sepsis, specifically COVID-19-associated sepsis, and those with bacterial sepsis. Conducted at Sichuan Provincial People's Hospital, the study will retrospectively analyze data from ICU patients admitted between July 2021 and December 2023. The primary objective is to identify reliable biomarkers and diagnostic methods to improve patient outcomes through personalized diagnostic and therapeutic strategies.

Primary Outcome Measures: Mortality rate, The primary outcome measure is the mortality rate of patients diagnosed with sepsis. This measure will compare the 28-day survival rate in the ICU between patients with bacterial sepsis and those with viral sepsis, specifically COVID-19-associated sepsis., 28 days|Length of ICU stay, This outcome measure will assess the length of ICU stay for patients diagnosed with sepsis. The comparison will be made between bacterial sepsis and viral sepsis patients, considering the duration of ICU admission from the time of diagnosis until discharge or death., From ICU admission until discharge or death, assessed up to 28 days
Secondary Outcome Measures: Levels of key inflammatory markers, This outcome measure will assess the levels of key inflammatory markers, including IL-2, IL-6, IL-8, IL-10, TNF-α, MYD88, mCD64, and nCD64. The comparison will be made between bacterial and viral sepsis patients to identify significant differences in cytokine profiles and their impact on sepsis outcomes., baseline (Measured at the time of ICU admission)|Incidence of secondary infections, This outcome measure will evaluate the incidence of secondary infections in patients diagnosed with sepsis. The focus will be on identifying the occurrence of secondary bacterial or fungal infections in both bacterial and viral sepsis groups, as well as the impact of these infections on patient outcomes., Assessed from the time of ICU admission up to 28 days or until discharge or death, whichever came first
SGLT2-inhibitors on PC-AKI
NCT Number: NCT06491953
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Impact of SGLT2-inhibitors on PC-AKI in ACS Patients Receiving Invasive Strategy
Interventions: DRUG: SGLT-2 inhibitors
Sponsor: Shenyang Northern Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 3600
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-01
Completion Date: 2024-12-31
Locations: General Hospital of Northern Theater Command, Shenyang, Liaoning, China

Summary:
Percutaneous coronary intervention (PCI) is one of the most common invasive strategies employed in the diagnosis and treatment of coronary artery disease (CAD) patients. Invasive procedures necessitate the use of iodine-based contrast agents, which could lead to post contrast acute kidney injury (PC-AKI).

Sodium-glucose cotransporter 2 (SGLT-2) inhibitors, as a class of oral antidiabetic medications, function by inhibiting SGLT-2, preventing the reabsorption of filtered glucose by the kidneys and thereby increasing glucose excretion in urine. In recent years, a series of studies including EMPA-REG OUTCOME, CREDENCE, DAPA-CKD, DECLARE-TIMI 58, and the CANVAS program have consistently demonstrated that SGLT-2 inhibitors not only effectively improve renal function and slow the progression of chronic kidney disease (CKD), but also significantly reduce the risk of cardiovascular adverse events. Nevertheless, due to their osmotic diuretic effect, SGLT-2 inhibitors can lead to a reduction in renal blood volume within the early phase of application (within two weeks), temporarily augmenting the renal workload and resulting in a decrease in estimated glomerular filtration rate (eGFR).

Consequently, there remains a need to ascertain the specific role of SGLT-2 inhibitors in the prevention of PC-AKI and provide evidence-based support for their application in this context.

Primary Outcome Measures: Incidence of Post contrast acute kidney injury (PC-AKI), PC-AKI was defined by the European Society of Genitourinary Radiology (EUSR): increase in serum creatinine by ≥ 0.3 mg/dl (≥ 26.5 μmol/l) within 48 hours or increase in serum creatinine (SCr) to ≥ 1.5 times the known baseline, 48 hours after procedure
Secondary Outcome Measures: Major adverse cardiovascular and cerebrovascular events(MACCE), Cardiovascular death, non-fatal myocardial infarction, stroke, or ischemic-driven target vessel revascularization, up to 12 months|All-cause mortality, up to 12 months
Comparison of the Role of Losartan Alone vs Hydrochlorothiazide Plus Losartan
NCT Number: NCT06491940
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Proteinuria
Interventions: DRUG: Losartan|DRUG: Losartan + Hydrochlorothiazide
Sponsor: RESnTEC, Institute of Research
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 234
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2025-07-31
Locations: Medical department, Bahawal Victoria Hospital, Bahawalpur, Punjab, 06318, Pakistan

Summary:
Losartan, an angiotensin II receptor blocker, has already been established as a treatment for diabetic nephropathy due to its ability to reduce blood pressure and mitigate the progression of kidney damage. However, the addition of a diuretic like hydrochlorothiazide may offer synergistic benefits in reducing proteinuria by addressing both the underlying renal pathology and potential volume overload in these patients. The current study aims at determining and comparing the role of losartan alone vs hydrochlorothiazide plus losartan in reducing proteinuria in diabetic nephropathy patients.

Primary Outcome Measures: Reduction of proteinuria, Efficacy will be labeled yes if reduction of proteinuria/albuminuria from the value before commencing treatment will be observed., 4 months