pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Evaluating a Lifestyle Intervention to Prevent Recurrence of Diabetic Foot Ulcers
NCT Number: NCT06487780
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Diabetic Foot|Diabetic Foot Ulcer|Foot Ulcer, Diabetic|Foot Wound
Interventions: BEHAVIORAL: Lifestyle-focused Occupational Therapy Intervention|OTHER: Education
Sponsor: University of Southern California
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-09-01
Completion Date: 2026-12-31
Locations: Rancho Los Amigos National Rehabilitation Center, Downey, California, 90242, United States|Keck Hospital of USC, Los Angeles, California, 90033, United States|Los Angeles General Medical Center, Los Angeles, California, 90033, United States

Summary:
People with diabetes often experience foot ulcers, which can harm their ability to move, lower their quality of life, and increase the chances of losing a limb. These diabetic foot ulcers (DFUs) commonly come back (recur) even after they've healed, so it's crucial to stop them from returning to avoid toe, foot , or leg amputation. While wearing special shoes to reduce pressure on the feet is essential for healing and preventing DFUs, many people struggle to follow this treatment plan once their ulcers have healed. This study aims to see if a lifestyle-focused program can help participants create daily routines and habits that make it easier to consistently use special shoes and take care of their diabetes and feet to prevent ulcers from recurring.

Primary Outcome Measures: Numbers of participants who have completed the study, Investigators will measure participant attendance, completion of planned/scheduled sessions, retention of participants in the intervention and education (control) groups., 6-month
Secondary Outcome Measures: Numbers of participants with diabetic foot ulcer recurrence, Rates of foot ulcer recurrence and any amputation., 6-month|Numbers of participants who report satisfaction with the program, Participants will complete the Short-form Patient Satisfaction Questionnaire (PSQ-18). The 18 items' scale ranges from 1 (strong agree) to 5 (strongly disagree). Selected participants will be invited to participate in semi-structured interviews., 6-month|Number of participants with diabetes distress, Participants will complete the Diabetes Distress Scale (DDS), a 17-item self-report instrument. Each item is rated on a 6-point scale from 1 (not a problem) to 6 (a very significant problem., 6-month|Participant's Quality of Life, Participants will complete the Patient-Reported Outcomes Measurement Information System (PROMIS) that evaluate physical, mental, and social health., 6-month
The Validity of the Use of Imaging in Cervical Cancer Staging
NCT Number: NCT06487767
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Cervical Cancer Stage, Imaging Modalities
Interventions: OTHER: Surgery
Sponsor: University of Pretoria
Collaborators: Dr Edwin Mnisi|Prof Mike Sathekge|Prof N Khan
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-01
Completion Date: 2026-12-31
Locations: Kalafong Provincial Tertiary Hospital, Pretoria, Gauteng Province, South Africa

Summary:
The study wil aim to investigate the accuracy of imaging in the staging of women diagnosed with cervical cancer

Primary Outcome Measures: Sensitivity and specificity, Metrics of imaging, 2 years
New-onset Chronic Pelvic Pain in Transgender People Using Testosterone Therapy: an Exploratory Qualitative Study.
NCT Number: NCT06487754
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Transgender Persons|Pelvic Pain|Testosterone|Gender-Affirming Care
Sponsor: University Hospital, Grenoble
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 15
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07
Completion Date: 2025-12

Summary:
This descriptive qualitative study aim to describe the characteristics of pelvic pain in transgender (trans) individuals using testosterone therapy and the impact on their quality of life. This study also aim to understand the levers and obstacles to consulting a health care professional.

Primary Outcome Measures: Pelvic pain and impact on quality of life description, verbatim, 1.5 hours during semi structured interviews
Secondary Outcome Measures: pelvic pain intensity, visual analog scale, at the beginning of the interview
The Validity of Urinary Titin and Skeletal Muscle Index as Predictor of Muscle Weakness in Critically Ill Patients. A Prospective Cohort Study
NCT Number: NCT06487728
Status: ENROLLING_BY_INVITATION
Study Type: OBSERVATIONAL
Conditions: Urinary Titin
Interventions: DIAGNOSTIC_TEST: Urinary titin
Sponsor: Zagazig University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 161
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-01
Completion Date: 2025-02-01
Locations: Faculty of medicine, Zagazig university, Zagazig, Sharkia, Egypt

Summary:
Although skeletal muscle atrophy is common in critically ill patients, biomarkers associated with muscle atrophy have not been identified reliably. Titin is a spring-like protein found in muscles and has become a measurable biomarker for muscle breakdown and intensive care unit-acquired weakness in critically ill patients, in whom titin loss is a possible pathophysiology. The skeletal muscle index (SMI) is an alternative biomarker for muscle weakness, which is calculated by dividing the cross-sectional area (cm2) of the skeletal muscle at the level of the third lumbar vertebra by the square of the patient's height (m2) on CT The possibility of using urinary titin and skeletal muscle index for early prediction of muscle weakness in critically ill patients.

Primary Outcome Measures: The relationship between cumulative urinary titin level and rate of rectus femoris muscle atrophy on days 1 and 7 of ICU admission, Measurement of urinary titin level and its correlation to muscle index, At day 1 and 7 day of icu admission
Safety and Efficacy of Systemic Chemotherapy Plus PD-1 Inhibitor in Combination With Bevacizumab in Gastric Cancer With Peritoneal Metastasis
NCT Number: NCT06487715
Status: ENROLLING_BY_INVITATION
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Gastric Cancer Peritoneal Metastases
Interventions: DRUG: albumin-bound paclitaxel (260 mg/m2, d1)|DRUG: S-1|DRUG: sintilimab|DRUG: bevacizumab
Sponsor: Wuhan Union Hospital, China
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 42
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-03-01
Completion Date: 2026-03-01
Locations: Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, 430022, China

Summary:
It is an open label, phase II study involved receiving albumin-bound paclitaxel plus S-1 combined with sintilimab and bevacizumab in patients with gastric cancer peritoneal metastasis.

Primary Outcome Measures: Overall survival rate, 1 year
Secondary Outcome Measures: Progression free survival, 1 year|Ascites drainage-free survival, 1 year|Objective Response Rate, 1 year
A Phase lb/lI Clinical Study in Advanced or Metastatic Esophageal Squamous Cell Carcinoma
NCT Number: NCT06487702
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Esophageal Squamous Cell Carcinoma
Interventions: DRUG: fruquintinib++Candonilimab+ Tegafur，Gimeracil and Oteracil Potassium
Sponsor: Rui-hua Xu, MD, PhD
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 70
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-10
Completion Date: 2027-06-10
Locations: Medical Oncology,Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, 510060, China

Summary:
This is a prospective, single-arm, open-label，multi-center, phase Ib/II study, aiming to evaluate the efficacy and safety of Fruquintinib combined With Cadonilimab (AK104) and Tegafur，Gimeracil and Oteracil Potassium in patients with locally advanced or metastatic esophageal squamous cell carcinoma after the failure of first-line treatments.

Primary Outcome Measures: MTD and/or PR2D, To determine the Maximum Tolerated Dose ( MTD) and/or PR2D of fruquintinib combined with Cadonilimab and Tegafur,Gimeracil and Oteracil Porassium in patients with Esophageal squamous cell carcinoma (Phase Ib), During the first 3 weeks|16-Week Progression-free Survival (PFS) Rate (Phase II), 16-Week Progression-free survival (PFS) rate is defined as the percentage of patients who are progression-free (stable disease, partial response, or complete response as defined by RECIST v1.1 criteria) at 16 weeks post registration, 16 week
Secondary Outcome Measures: Overall Response Rate (ORR) (Phase Ib）, from treatment up to progressive disease or EOT due to any cause up to 1 year, Tumor assessment will be performed using radiography method every 6 weeks until the occurrence of progressive disease (PD), using RECIST v 1.1|Disease control rate (DCR) (Phase Ib）, Tumor assessment will be performed using radiography method every 6 weeks until the occurrence of progressive disease (PD), using RECIST v 1.1, from treatment up to progressive disease or EOT due to any cause up to 1 year|Overall survival (OS) （Phase Ib), Baseline to measured date of death from any cause, up to approximately 1 year
Oral Manifestations in Chronic Kidney Disease.
NCT Number: NCT06487689
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Chronic Kidney Diseases|Hemodyalysis|Pre-dyalisis|Peritoneal Dyalisis
Sponsor: José López Lopez
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 449
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-01-10
Completion Date: 2024-05-25
Locations: University of Barcelona, Hospitalet de Llobregat, Barcelona, 08907, Spain

Summary:
The goal of this observational study is to investigate oral manifestations in patients with Chronic Kidney Disease (CKD) for early detection, that alterations play an important point for dental guide during the progression and type of treatment of CKD .

An oral exam was performed for detection oral manifestations, age, smoking, alcoholic and oral hygiene habits were collected.

The study has 3 groups under study: hemodialysis (HD), peritoneal dialysis (PD) and pre-dialysis (P-D)

Primary Outcome Measures: Periodontal status, periodontrogram (probe CP12), 2 years
Secondary Outcome Measures: Sex, qualitative variable: Male/Female, 2 years|Age, nominal variable: years, 2 years|Type of CKD, qualitative variable: pre-dialysis, peritoneal dialysis, hemodialysis, 2 years|time with CKD, nominal variable: years, 2 years|time of treatment, nominal variable: years, 2 years|smoking and alcohol habits, qualitative variable: YES/NO, 2 years|oral lesions, qualitative variable: uremic odor, xerostomia, taste disorder, petechiae, tongue coating, 2 years
Long Term Follow up of Toe-to-hand Transfers
NCT Number: NCT06487676
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Toe Transfer|Free Tissue Flap|Patient Reported Outcome Measures
Interventions: PROCEDURE: Toe transfer|PROCEDURE: Replantation
Sponsor: Chang Gung Memorial Hospital
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 75
Study Design: Observational Model: |Time Perspective: p
Start Date: 2015-07-31
Completion Date: 2023-10-27

Summary:
Toe transfers are perceived to have changed the landscape of the injured hand over the last half century, yet there are limited validated data that unequivocally support the functional role of toe transfers after traumatic digital amputation. There also remain unanswered questions about what factors critically influence functional outcomes, be it sensory recovery, grip strength or other modality. Furthermore, the use of validated patient reported outcome measures (PROMs) in large series of toe transfers with long term follow up, is lacking.

Primary Outcome Measures: Michigan Hand Questionnaire, Validated Hand function patient reported outcome measured. 0-100. Higher is better, Single time-point, on average 22 years after surgery
Secondary Outcome Measures: Short Form 36, Short Form 36 Quality of Life. 0-100. Higher is better, Single time-point, on average 22 years after surgery|Foot Function Index, Validated foot function Patient reported outcome measure. 0-100. Lower is better, Single time-point, on average 22 years after surgery|Aesthetic evaluation, Subjective evaluation of toe transfer appearance using a Visual Analogue Scale, not validated, Longitudinal. 3 timepoints: 1 day before surgery, 1 day after surgery, and on average 22 years after surgery
Other Outcome Measures: Range of motion, Total active range of motion of digit. Measured in degrees per digit, Single time-point, on average 22 years after surgery|Grip strength, Measured with hand dynamometer. Measured in kilograms., Single time-point, on average 22 years after surgery|Sensation, Measured with discriminator device. Two point discrimination measured in millimetres, Single time-point, on average 22 years after surgery
TACE Combined With Immune Checkpoint Inhibitors for Liver Malignant Tumors
NCT Number: NCT06487663
Acronym: TIKET
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Hepatocellular Carcinoma Non-resectable|Cholangiocarcinoma Non-resectable|Liver Metastases|Liver Malignant Tumors
Interventions: PROCEDURE: TACE with ICI
Sponsor: Tianjin Medical University Cancer Institute and Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2020-10-27
Completion Date: 2026-10-27
Locations: Tianjin Medical University Cancer Institute and Hospital, Tianjin, China

Summary:
This study will evaluate the efficacy and safety of TACE combined with immune checkpoint inhibitors to treat unresectable hepatocellular carcinoma.

Primary Outcome Measures: PFS, Progression free survival, 3 years|OS, Overall Survival, 3 years
Secondary Outcome Measures: ORR, Objective response rate, 3 years
Other Outcome Measures: TTP, Time to Progression (TTP) as Determined by Investigator, 3 years|DOR, Duration of Responses (DOR) as Determined by Investigator, 3 years|AE, Percentage of Participants With Adverse Events, Baseline up to approximately 48 months
An Engineered Sirpα Fused to Anti-Pd-L1 And Tgf-β Fusion Protein (HCB301) in Subjects With Selected Advanced Tumors
NCT Number: NCT06487624
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Advanced Solid Tumor|Refractory Hodgkin Lymphoma
Interventions: DRUG: HCB301
Sponsor: FBD Biologics Limited
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-15
Completion Date: 2026-08-31

Summary:
The purpose of this study is to find out whether IV injection of HCB301 is an effective treatment for different types of advanced solid tumors and relapsed and refractory classical Hodgkin lymphomas and what side effects (unwanted effects) may occur in subjects aged 18 years old and above.

Primary Outcome Measures: Number/incidence and percentage of subjects with adverse events, including ADA., To evaluate the safety and tolerability of HCB301., 12 months|Number of subjects with MTD and RDE of HCB301., To determine the MTD and RDE., 12 months
Secondary Outcome Measures: Overall Rate Response (ORR), ORR is defined as the proportion of participants who have a partial response (PR) or critical response (CR)., 12 months|Duration of Response (DoR), DoR is defined as time from date of initial documentation of a response (PR or CR) to date of first documented evidence of progressive disease (PD)., 12 months|Disease Control Rate (DCR), DCR is defined as the proportion of participants who have a partial response (PR), critical response (CR), or disease stable (SD)., 12 months|Progression-Free Survival (PFS), Defined as the duration from the start of treatment until tumor progression or death of any cause., 12 months|Peak Plasma Concentration (Cmax) of HCB301, Peak Plasma Concentration (Cmax) of HCB301 following single and repeated IV doses of HCB301 at different dose levels., 12 months|Area under the plasma concentration versus time curve (AUC) of HCB301, Area under the plasma concentration versus time curve (AUC) of HCB301 following single and repeated IV doses of HCB301 at different dose levels., 12 months|Time to maximum drug concentration in plasma (Tmax) of HCB301, Time to maximum drug concentration in plasma (Tmax) of HCB301 following single and repeated IV doses of HCB301 at different dose levels., 12 months|Terminal elimination half-life (t1/2) of HCB301, Terminal elimination half-life (t1/2) of HCB301 following single and repeated IV doses of HCB301 at different dose levels., 12 months
Other Outcome Measures: CD47 receptor occupancy on circulating red blood cells (RBCs), CD47 receptor occupancy on circulating red blood cells (RBCs) will be measured as an indication of target engagement., 12 months|Concentration of potential PD biomarkers in participants will be assess., Changes in CD47 receptor occupancy on circulating CD3+ T cells and TGFβ1, 2, 3 will be assessed after HCB301 treatment., 12 months|ctDNA detection, ctDNA detection in participants using next-generation sequencing (NGS )., 12 months
ANG-First Trial (Angiotensin II as First-Line Vasopressor Therapy in Cardiac Surgery)
NCT Number: NCT06487585
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Hypotension After Cardiac Surgery
Interventions: DRUG: Angiotensin II
Sponsor: University of Maryland St. Joseph Medical Center
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-20
Completion Date: 2025-10-20

Summary:
The purpose of this research is to evaluate the use of Angiotensin II in patients with low blood pressure post-surgery. Your information will be collected for 28 days post the procedure and initiation of the study drug to assess for safety events and complications.

Primary Outcome Measures: Incidence of postoperative acute kidney injury, atrial fibrillation, The primary endpoint will be measured by comparing the incidence of new-onset atrial fibrillation or acute kidney injury, 28 days
Secondary Outcome Measures: Hours on Vasopressors, 28 days|Total IVF, 28 days|ICU LOS, 28 days|Postoperative LOS, 28 days|Any major STS complication, 28 days|30-day mortality, 30 days
A Study to Assess Pharmacokinetic Exposures Following Intravenous and Subcutaneous Administration of Risankizumab in Healthy Participants
NCT Number: NCT06487572
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Healthy Volunteers
Interventions: DRUG: Risankizumab|DRUG: Risankizumab
Sponsor: AbbVie
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-07-23
Completion Date: 2025-05-12
Locations: Clinical Pharmacology Of Miami /ID# 268219, Miami, Florida, 33014, United States|Acpru /Id# 267057, Grayslake, Illinois, 60030, United States

Summary:
The objective of this study is to compare pharmacokinetic exposures following intravenous and subcutaneous administration of Risankizumab.

Primary Outcome Measures: Number of Participants Experiencing Adverse Events, An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment., Up to approximately 140 days|Maximum Observed Serum Concentration (Cmax) of Risankizumab, Cmax of Risankizumab., Up to approximately 140 days|Time to Cmax (Tmax) of Risankizumab, Tmax of Risankizumab., Up to approximately 140 days|Area Under the Serum Concentration-Time Curve (AUC) of Risankizumab, AUCt of Risankizumab., Up to approximately Week 4
Repletion of Ergothioneine in Patients With Kidney Failure
NCT Number: NCT06487546
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Esrd
Interventions: DIETARY_SUPPLEMENT: Ergothioneine
Sponsor: Stanford University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-10-01
Completion Date: 2027-10-01

Summary:
Dialysis removes potentially harmful chemicals from the blood but can also remove potentially valuable chemicals. One potentially valuable chemical called ergothioneine, which comes from our diet, is low in the blood of people receiving dialysis. For this research study, we hope to learn how well a daily ergothioneine supplement will replenish the levels in the blood of people with kidney failure.

Primary Outcome Measures: erythrocyte levels of ergothioneine, ergothioneine levels will be measured in whole blood, weeks 1, 2, 4, 8, 12, and 16 (while taking ergothioneine); and weeks 20 and 24 (after stopping ergothioneine)|plasma levels of ergothioneine, ergothioneine levels will be measured in plasma, weeks 1, 2, 4, 8, 12, and 16 (while taking ergothioneine); and weeks 20 and 24 (after stopping ergothioneine)
The Effect of Different Images Watched With Virtual Reality During Phlebotomy
NCT Number: NCT06487520
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Pain Management|Anxiety Management|Blood Donation|Virtual Reality
Interventions: OTHER: group watching hot environment image|OTHER: group watching cold environment image
Sponsor: Zonguldak Bulent Ecevit University
Sex: ALL
Age: ADULT
Enrollment: 120
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2019-04-18
Completion Date: 2020-07-10
Locations: Zonguldak Bulent Ecevit University, Zonguldak, Turkey

Summary:
Aim: The purpose of this study was to investigate the effect of watching a cold environment image via virtual reality on pain and anxiety related to phlebotomy procedure in volunteer blood donors.

Methods: The study was conducted between June 2019 and December 2019 with 120 healthy individuals who applied for blood donation for the first time in Northern Turkey. Individuals included in the study were assigned to intervention, placebo and control groups with 40 people in each group by block randomization method. During the phlebotomy procedure, the intervention group watched a cold environment image via virtual reality, the placebo group watched a hot environment image, and the control group received standard application. "Descriptive Characteristics Form", "Visual Comparison Scale", "State and Trait Anxiety Inventory" and The CONSORT checklist were used to collect data.

Primary Outcome Measures: pain intensity in cm, The VAS is a 100 mm (10 cm) ruler that can be used horizontally or vertically. The value of "0" at the starting level defines painlessness, and the value of "10" at the ending level defines the most severe pain. The individual marks the intensity of pain they experience on this scale. In this study, the score measurements were determined in centimeters (cm) on the VAS prepared vertically to determine the intensity of pain experienced by individuals during phlebotomy application.individuals.during the procedure. One end indicated lack of pain and the other the most.Pain intensity was evaluated in centimeters.severe pain possible. Pain severity was evaluated in millimeters., 6 months|State-Trait Anxiety Inventory (STAI) score, The inventory is in the form of a 4-point Likert scale, and the items in the State and Trait Anxiety Subscales are marked according to the degree of severity of the emotions and behaviors. There are ten items in the State Anxiety Scale and seven items in the Trait Anxiety Scale that contain reversed statements., 6 months
Secondary Outcome Measures: weight in kilograms, Body mass index normal weight (18.5-24.9 kg/m2), 6 months|Pressure pain threshold, The average value of the pressure pain threshold, which is defined as the point of pain.from three measurements taken at 5-second intervals from the elbow region of the left upper extremity where no intervention was performedperception and can vary from person to person, is between 8-16 Lb, 6 months
Metabolic Impact and Compliance of Controlled, Varying, Mediterranean Diets in Pre-Surgical Prostate Cancer Populations (PROVISIONS)
NCT Number: NCT06487507
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Prostate Cancer
Interventions: BEHAVIORAL: Low fat diet|BEHAVIORAL: Lower carbohydrate diet
Sponsor: University of Miami
Sex: MALE
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-10-01
Completion Date: 2025-10-01
Locations: University of Miami, Miami, Florida, 33136, United States

Summary:
The study aims to investigate whether following a controlled Mediterranean-style diet prior to robotic-assisted radical prostatectomy surgery in patients diagnosed with prostate cancer affects fasting insulin levels and other values that can be measured in blood and tissue samples from surgery.

Primary Outcome Measures: Proportion of patients consuming Mediterranean diet, Defined as the proportion of patients who consumed greater than 80% of provided calories using diet records., Up to 2 weeks
Secondary Outcome Measures: Change in fasting insulin, Measured in milliliters, Baseline to 2 weeks|Change in high-sensitivity c-reactive protein, Measured in milligrams per liter, Baseline to 2 weeks|Change in fasting glucose, Measured in milligrams per deciliter, Baseline to 2 weeks|Change in blood pressure, Measured in millimeters of mercury, Baseline to 2 weeks|Dietary behavior as measured by diet records questionnaire, Measured in percentage of meals consumed by the participants, Up to 2 weeks|Number of treatment related adverse events, Measured by fewer than three grade 3 adverse events using the NCI CTCAE version 6.0., Up to 2 weeks
Evaluating the Efficacy of 2-Octyl Cyanoacrylate (2-OCA) With Four Interrupted Sutures in Adult Male Circumcision
NCT Number: NCT06487494
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Phimosis|Paraphimosis
Interventions: PROCEDURE: Circumcision wound closure using 2-octyl cyanoacrylate glue with four interrupted sutures|PROCEDURE: Circumcision wound closure using continuous sutuing
Sponsor: University of Manitoba
Sex: MALE
Age: ADULT, OLDER_ADULT
Enrollment: 24
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07
Completion Date: 2024-09
Locations: Men's Health Clinic Manitoba, Winnipeg, Manitoba, R3K 1M3, Canada

Summary:
This study aims to determine whether cyanoacrylate glue is a non-inferior alternative to continuous suturing for wound closure following adult circumcision. The primary objective of this study is to evaluate and compare operative time, pain, cosmesis, complications and patient satisfaction associated with the use of cyanoacrylate glue versus standard suturing for wound closure. To the best of our knowledge, this will be one of the first studies to investigate the use of cyanoacrylate glue for wound closure following adult circumcision. The findings from this study could provide valuable insights into the potential benefits of using cyanoacrylate glue as a non-inferior alternative to continuous suturing for wound closure. Additionally, this study may also inform clinical practice guidelines on the most effective techniques for wound closure following adult circumcision.

Primary Outcome Measures: Cosmesis, A cosmetic appearance satisfaction questionnaire will be administered at weeks 6 and 12 post-operation., 6 and 12 weeks post-operation|Post-operative Pain, Using a visual analogue pain scale \[range 0-10; 0 = no pain, 10 = maximal pain\], pain will be assessed as reported by the patient to determine their pain., Immediately post-operation and 6 weeks post-operation|Complication Rate, Measuring and recording any adverse events post procedure such as surgical site infection, bleeding, hematoma, diffuse swelling, and increased sensitivity amidst intercourse., 6 and 12 weeks post-operation|Intra-Operative Time, Intra-operative time will be measured starting when the physician makes the first incision and ends when sutures are finished., During the operation
Risk Factors In Heart Failure Patients With Preserved Ejection Fraction
NCT Number: NCT06487468
Acronym: RIPE-HF
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Heart Failure With Preserved Ejection Fraction
Sponsor: Xiangtan Central Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 9419
Study Design: Observational Model: |Time Perspective: p
Start Date: 2014-05-01
Completion Date: 2024-01-31

Summary:
This study aimed to identify the independent risk factors associated with heart failure readmission, cardiac mortality and all-cause death among patients discharged from Xiangtan Central Hospital with heart failure and preserved ejection fraction (HFpEF). Understanding related risk factors might add future clinical decision making for individualized post discharge management of HFpEF patients aiming to improve the outcome of discharged HFpEF patients.

Primary Outcome Measures: All-cause death（people）, Risk factors of all-cause death are analyzed（Increase the factors that contribute to the occurrence of endpoint events）, The patients are clinically followed up until January 31, 2024, per clinical visit or telephone call or community visit.
Secondary Outcome Measures: Cardiovascular death and Heart failure readmission（people）, The risk factors related to cardiovascular death and heart failure readmission post discharge are analyzed.（Increase the factors that contribute to the occurrence of endpoint events）, The patients are clinically followed up until January 31, 2024, per clinical visit or telephone call or community visit.
A Clinical Study of SPH7485 Tablets in the Treatment of Advanced Solid Tumors.
NCT Number: NCT06487455
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Advanced Solid Tumor
Interventions: DRUG: SPH7485
Sponsor: Shanghai Pharmaceuticals Holding Co., Ltd
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 170
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-06
Completion Date: 2027-12-31
Locations: XiangYa Hospital CentralSouth University, Changsha, China|Fujian Cancer Hospital, Fuzhou, China|Zhejiang Cancer Hospital, Hangzhou, China|Yunnan Cancer Hospital, Kunming, China|Fudan University Shanghai Cancer Center, Shanghai, China|Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China

Summary:
To evaluate the efficacy and safety of SPH7485 tablets in patients with advanced solid tumors.

Primary Outcome Measures: DLT(Dose-limiting toxicity), Measurement of DLT of SPH7485 in all subjects, Approximately 24 days|Maximum tolerated dose（MTD）, Measurement of MTD of SPH7485 in all subjects, Approximately 24 days|Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs), Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs), Approximately 2 years
Secondary Outcome Measures: ORR(Objective Response Rate), Tumor response will be evaluated according to the Response Evaluation Criteria Solid Tumors (RECIST) criteria version 1.1., Approximately 2 years|DoR(Duration of response), DOR was defined as the time interval between the date of the first documented response (CR or PR) and the date of the first documented disease progression or death due to any cause, Approximately 2 years|DCR(Disease Control Rate), DCR was defined as the percentage of patients who have achieved complete response, partial response and stable disease, Approximately 2 years|PFS(Progression-free survival), PFS was defined as the time interval between study treatment initiation and the first occurrence of progression disease or death, whichever occurred first., Approximately 2 years|PK(Pharmacokinetics):Tmax, Time to peak plasma concentration (Tmax), Approximately 3 days|PK(Pharmacokinetics):Cmax, Maximum serum concentration(Cmax), Approximately 3 days|PK(Pharmacokinetics):AUC, Area under the plasma concentration versus time curve (AUC), Approximately 3 days
Management of Postoperative Pain in France: a Prospective National Study
NCT Number: NCT06487442
Acronym: ALGOSFAR2
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Pain
Sponsor: Société Française d'Anesthésie et de Réanimation
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 3000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-30
Completion Date: 2024-12-07

Summary:
Managing postoperative pain is an ongoing challenge. Therefore, frequent surveys are needed to constantly evaluate and improve perioperative pain care. The French reference audit was published in 2008. Ten years later, the French AlgoSFAR survey of 70 centres and 3,315 patients highlighted a clear improvement in practices. However, these data have never been published in a referenced journal due to significant methodological biases.

In 2024, we do not have recent French data based on rigorous methodology in the field of postoperative pain management.

The objective of this study is to reassess postoperative pain management in France. This is a prospective national survey. The proposed methodology will make it possible to provide a relevant snapshot of the practices and quality of care. Secondarily, areas for improvement can be identified and these results will also help in the drafting of future recommendations.

100 centres representative of the French map of surgical centres will be contacted.

Inclusions will take place over 2 days, identical for all centres. All patients eligible for inclusion during this period will be included.

Primary Outcome Measures: Pain assessment, Pain assessed with a numerical rating scale (NRS), At rest over the first 3 days postoperatively
Secondary Outcome Measures: Preoperative pain assessment, Pain assessed with a numerical rating scale (NRS), Preoperative assessment|Morphine consumption, Morphine consumption in mg, Over the first 3 postoperative days|Frequency of administration of non-morphine analgesics, Frequency of administration of non-morphine analgesics, At rest over the first 3 days postoperatively|Frequency of administration of regional anaesthesia, Frequency of administration of regional anaesthesia, At rest over the first 3 days postoperatively|Frequency of postoperative nausea and vomiting (PONV), Frequency of postoperative nausea and vomiting (PONV), At rest over the first 3 days postoperatively
Short Course Radiotherapy With Sequential Disitamab Vedotin Combined With S-1 and Sintilimab as Whole Course Neoadjuvant Therapy for HER2 Expressed Locally Progressive Gastric Cancer
NCT Number: NCT06487429
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Gastric Cancer
Interventions: DRUG: Short range radiotherapy with sequential Disitamab Vedotin combined with S-1 and xindilizumab
Sponsor: Wuhan Union Hospital, China
Collaborators: RemeGen Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 28
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-05-08
Completion Date: 2028-05-31
Locations: Zhang Tao, Wuhan, Hubei, 430000, China

Summary:
This study is a prospective, open label, phase II clinical study intended to include patients with locally advanced gastric adenocarcinoma who have not undergone any treatment and are eligible for surgery. The study aims to evaluate the efficacy and safety of the short course sequential radiotherapy regimen of Disitamab Vedotin combined with S-1 and Sintilimab in neoadjuvant therapy for HER2 expressing locally advanced gastric cancer.

Primary Outcome Measures: pathological complete response (pCR) rate, Pathological complete response rate (PCR) assessed by the blind independent Review Committee, defined as theabsence of viable tumour cells in the resected primary tumour specimen and all sampled regional lymph nodes(yPTONO), an expected average of 4 months
Secondary Outcome Measures: Overall Survival, The time from the date of randomization to the death caused by any cause, an expected average of 5 years|RO resection rate, The rate of negative margin microscopically, an expected average of 5mouths|dverse events (AEs), Adverse events and surgical safety, an expected average of 5 years|Primary pathological response (MPR) rate, ≤ 10% residual live tumor, an expected average of 1 years|Disease free survival (DFS), The time from surgical resection to local recurrence, an expected average of 5 years
A Trial to Assess the Bioequivalence of Tiotropium Bromide Inhalation Powder in Healthy Adult Participants Under Fasting Conditions
NCT Number: NCT06487416
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Interventions: DRUG: Tiotropium Bromide Inhalation Powder|DRUG: Spiriva®Handihaler®
Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Sex: ALL
Age: ADULT
Enrollment: 186
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-06-10
Completion Date: 2024-10
Locations: The First Affiliated Hospital of Bengbu Medical University, Bengbu, Anhui, 233000, China

Summary:
Primary Objective: To evaluate the pharmacokinetics and bioequivalence of the test products Tiotropium Bromide Inhalation Powder (Strength: 18 mcg; manufactured by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.) and reference products Tiotropium Bromide Inhalation Powder (Spiriva®Handihaler®, Strength: 18 mcg, manufactured by Boehringer Ingelheim Pharma GmbH and CO.KG) by oral inhalation in healthy participants under fasting conditions.

Secondary Objective: To assess the safety of the test products Tiotropium Bromide Inhalation Powder (Strength: 18 mcg) and reference products Tiotropium Bromide Inhalation Powder (Spiriva®Handihaler®, Strength: 18 mcg) in healthy participants.

Primary Outcome Measures: Peak concentration (Cmax), Maximum plasma drug concentration, Pre-dose and 1 2, 3, 4, 5 6, 7, 8, 10, 15, 20, 30 minuets, 1, 2, 4, 8, 12, 24, 48, 72, 120, 168, 216 hours post-dose|Area under the plasma concentration versus time curve (AUC) 0-t, Plasma concentration-time curve from zero to the time of the last measurable time point t, Pre-dose and 1 2, 3, 4, 5 6, 7, 8, 10, 15, 20, 30 minuets, 1, 2, 4, 8, 12, 24, 48, 72, 120, 168, 216 hours post-dose|Area under the plasma concentration versus time curve (AUC) 0 - infinity, Area under the plasma concentration-time curve from zero to infinity, Pre-dose and 1 2, 3, 4, 5 6, 7, 8, 10, 15, 20, 30 minuets, 1, 2, 4, 8, 12, 24, 48, 72, 120, 168, 216 hours post-dose
Secondary Outcome Measures: The time to maximum plasma concentration (Tmax), The time to maximum plasma concentration (observed), Pre-dose and 1 2, 3, 4, 5 6, 7, 8, 10, 15, 20, 30 minuets, 1, 2, 4, 8, 12, 24, 48, 72, 120, 168, 216 hours post-dose|The elimination half-life (t1/2), Elimination half-life of plasma concentration, Pre-dose and 1 2, 3, 4, 5 6, 7, 8, 10, 15, 20, 30 minuets, 1, 2, 4, 8, 12, 24, 48, 72, 120, 168, 216 hours post-dose|Terminal elimination rate constant (Kel), Terminal elimination rate constant, Pre-dose and 1 2, 3, 4, 5 6, 7, 8, 10, 15, 20, 30 minuets, 1, 2, 4, 8, 12, 24, 48, 72, 120, 168, 216 hours post-dose
A Study of Head and Neck MRI and Tumor Microenvironment Biomarkers
NCT Number: NCT06487403
Acronym: HN-Bio 02
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Squamous Cell Carcinoma of Head and Neck
Interventions: RADIATION: Standard of care external beam radiotherapy (single integrated boost)|RADIATION: Standard of care external beam radiotherapy (two-phase treatment)
Sponsor: University Health Network, Toronto
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2027-08-01
Locations: Princess Margaret Cancer Center, Toronto, Ontario, M5G 2M9, Canada

Summary:
This is a single centre prospective exploratory study of effects of radiation therapy on biomarker development in patients with newly diagnosed (head and neck squamous cell carcinoma) HNSCC receiving curative therapy. This research is part 2 of the HN-BIO study.

Primary Outcome Measures: Confirm feasibility of recruitment of HN patients for on treatment repeat biopsy of the primary tumor +/- neck nodes, Achieve a minimum recruitment rate of one patient per month., 7 weeks|Change in fMRI during radiotherapy, Study association of changes in fMRI and tissue biomarkers during radiotherapy. Assessed through hypoxic regions visible on imaging scans., 7 weeks|Assess changes in tumor microenvironment during differing radiotherapy scheduling via repeat biopsy., Assess effect of varying radiotherapy treatment volumes on changes in tumor microenvironment via repeat biopsy before and during radiotherapy. Quantify effect of delayed treatment of dLN on dynamic changes tumor immune micro-environment and hypoxia status during radiotherapy. Perform exploratory analysis of study data correlating changes in tumor microenvironment and hypoxia status with disease response to therapy., 7 weeks
Secondary Outcome Measures: Validate novel and established fMRI imaging as predictive and prognostic radiotherapy biomarkers for HNSCC, Correlate changes in TME and hypoxia with changes in fMRI on repeat assessment. Correlate fMRI characterized tumor with pathological post-operative specimen., 7 weeks
Multi-component Intervention to Train Providers to Promote PrEP for Girls and Women in the Deep South
NCT Number: NCT06487390
Acronym: PrEP Pro
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: HIV Infections|Sexually Transmitted Diseases
Interventions: BEHAVIORAL: PrEP Pro training intervention
Sponsor: University of Alabama at Birmingham
Collaborators: National Institute of Mental Health (NIMH)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
Start Date: 2023-04-21
Completion Date: 2024-07-31
Locations: University of Alabama at Birmingham, Birmingham, Alabama, 35205, United States

Summary:
The goal of this study is to adapt evidence-based curriculum on HIV epidemiology and PrEP prescription to train family medicine physician trainees to take a thorough sexual history and discuss HIV/STI prevention and PrEP options with adolescent patients in Alabama. The primary outcomes of the study are:

* Feasibility of the PrEP Pro training intervention
* Acceptability of the PrEP Pro training intervention

Secondary outcomes include:

* Behavioral changes in sexual history taking performed by physician trainees
* PrEP knowledge and prescribing practices
* HIV and STI screening practices

Participants will receive training on sexual history taking and HIV prevention options, including PrEP prescription and management. They will complete a pre-training survey (enrollment) and post-training survey (6 months post enrollment) to understand differences in knowledge and practice before and after receiving the training intervention. The post training survey will also assess acceptability and feasibility of the intervention. A subset of participants will complete qualitative in-depth interviews to further discuss their experiences with the program and suggestions for future adaptations.

Primary Outcome Measures: Feasibility (proportion of participants ranking feasibility high on 5-point Likert scale), Feasibility of Intervention: 4 items, 5-point Likert scale, higher score, more acceptable, 6 months|Acceptability, Acceptability of Intervention: 4 items, 5-point Likert scale, higher score, more acceptable; Intervention Appropriateness: 4 items, 5-point Likert scale, higher score, more acceptable; Evidence-Based Practice Acceptability scale: 15 items, 5 point Likert scale, higher score, more acceptable, 6 months
Secondary Outcome Measures: HIV epidemiology knowledge assessment, measured by baseline and 6-month (pre- and post-training) surveys, 6 months|Sexual history taking practices, measured by baseline and 6-month (pre- and post-training) surveys, qualitative interviews, 6 months|PrEP knowledge, willingness to prescribe, prescribing practices, measured by baseline and 6-month (pre- and post-training) surveys, qualitative interviews, EMR data, 6 months|STI screening practices, measured by baseline and 6-month (pre- and post-training) surveys, qualitative interviews, EMR data, 6 months|HIV screening practices, measured by baseline and 6-month (pre- and post-training) surveys, qualitative interviews, EMR data, 6 months
IX001 TCR-T In the Treatment of Advanced Pancreatic Cancer and Colorectal Cancer Induced by KRAS Mutations
NCT Number: NCT06487377
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Pancreatic Cancer|Colorectal Cancer
Interventions: BIOLOGICAL: IX001 TCR-T cells
Sponsor: Shanghai Pudong Hospital
Collaborators: ImmuXell Biotech Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 12
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07
Completion Date: 2026-12
Locations: Shanghai Pudong Hospital, Shanghai, Shanghai, China

Summary:
This is a single-arm, single-center, open-label clinical study aimed at evaluating the safety and efficacy of IX001 TCR-T (T cell receptor-engineered T-Cell) injection in patients with advanced pancreatic cancer and colorectal cancer induced by KRAS (Kirsten Rat Sarcoma Viral Oncogene) mutations. A total of 6-18 evaluable patients are planned to be enrolled. The study will include 4 dose groups, using a '3+3' dose escalation design.

Primary Outcome Measures: Dose-limiting Toxicity (DLT), Proportion of patients with DLT, 4 weeks|Adverse Events (AEs), Incidence and severity of adverse events, 96 weeks|Serious Adverse Events (SAEs), Incidence and severity of serious adverse events, 96 weeks
Secondary Outcome Measures: Objective Response Rate (ORR), The percentage of participants who achieved Complete Response (CR) or Partial Response (PR) based on RECIST version 1.1, 12 weeks|Disease Control Rate (DCR), The percentage of participants who achieved Complete Response (CR) or Partial Response (PR) or Stable disease (SD) based on RECIST version 1.1, 12 weeks|Changes in Serum Tumor Markers compared to Baseline, Changes of tumor markers in serum detected by immunofluorescence compared to baseline level, including carbohydrate antigen 19-9 (CA19-9), carcinoembryonic antigen (CEA), and carbohydrate antigen 12-5 (CA12-5), 12 weeks|Duration of response (DOR), DOR is defined as the time from the first evaluation of a tumor as CR or PR to the first evaluation as PD or death from any cause, 96 weeks|Time to response (TTR), TTR is defined as the time between cell infusion and initial disease assessment as CR or PR, 96 weeks|Progression-free survival (PFS), PFS is defined as the time from the date of cell infusion until the date of tumor progression or death from any cause, 96 weeks|Overall survival (OS), OS is defined as the time between the date of cell infusion and the death of the patient for any reason, 96 weeks|TCR gene copies, TCR gene copies detected by qPCR in peripheral blood, 96 weeks|TCR-T cell counts, TCR-T cell counts detected by flow cytometry in peripheral blood, 96 weeks|Proportion of patients with anti-IX001 antibodies in peripheral blood, Anti-drug Antibodies, 96 weeks