pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Efficacy of Extracorporeal Shock Wave Therapy, LASER Therapy and Cryotherapy in Patients Having Sacroiliitis
NCT Number: NCT06569615
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Sacroilitis
Interventions: OTHER: shock wave therapy|OTHER: LASER Therapy|OTHER: Cryotherapy|OTHER: Exercises
Sponsor: Najran University
Sex: MALE
Age: ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-25
Completion Date: 2025-02-27
Locations: Hashim Ahmed, Najrān, Najran, 1988, Saudi Arabia

Summary:
This research aimed to determine the effect of extracorporeal shock wave therapy, LASER therapy and cryotherapy on PPT, Pain and functional disability in patients having Sacroiliitis.

Primary Outcome Measures: Pain Pressure Threshold (PPT), Pain pressure threshold of muscle tenderness will be measured by using the algometer, 8 Weeks|Pain Intensity, Pain intensity will be measured by using the Visual Analogue Scale (VAS),a linear scale wherein patients indicate their pain intensity on a 10 cm line ranging from 'no pain' to 'worst imaginable pain', 8 Weeks
Secondary Outcome Measures: Functional Disability, Functional disability will be measured by using the Oswestry Disability Index (ODI),a validated 10-item questionnaire evaluating various dimensions of daily living, 8 Weeks
Real World European Investigation of Safety and Clinical Efficacy of the EVOQUE System (TRISCEND III EU)
NCT Number: NCT06569602
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Tricuspid Valve Regurgitation|Heart Valve Diseases|Cardiovascular Diseases
Interventions: DEVICE: Transcatheter Tricuspid Valve Replacement
Sponsor: Edwards Lifesciences
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 500
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-30
Completion Date: 2033-09-30
Locations: Herz-und Diabeteszentrum NRW, Bad Oeynhausen, Germany|Inselspital, Bern, Switzerland

Summary:
This is a prospective, single-arm, multi-center, real-world study of an the Edwards EVOQUE system.

Primary Outcome Measures: Tricuspid regurgitation grade, Number of patients with optimal TR grade (≤1 on a 0-5 grade scale), Up to 7 days, 30 days, and 1 year|Number of patients with major adverse events (MAE rates), The primary safety endpoint is the proportion of patients with major adverse events (MAEs) at 30 days, 30 days
Secondary Outcome Measures: All-cause mortality, Number of participants with all-cause mortality, 30 days, 1 year, and 2 years|Cardiovascular mortality, Number of participants with cardiovascular mortality, 30 days, 1 year, and 2 years|Heart failure hospitalizations, Number of patients with heart failure hospitalizations, 30 days, 1 year, and 2 years|Tricuspid valve re-intervention, Number of participants with tricuspid valve re-intervention, 30 days, 1 year, and 2 years|Health Status - Assessed by Kansas City Cardiomyopathy Questionaire (KCCQ) Scores, KCCQ is a 23-item, self-administered, validated questionnaire that quantifies physical function, symptoms, social function, self-efficacy, and quality of life for patients with heart failure. Scores range from 0 to 100 with higher scores indicating better function (100 = no symptoms, no limitations, and excellent quality of life)., 30 days, 1 year, and 2 years|NYHA Functional Class, Number of patients with improvement in NYHA class, 30 days, 1 year, and 2 years
Tissue Sodium Quantification in Patients With Primary Aldosteronism: See Sodium to Treat
NCT Number: NCT06569589
Acronym: SSTT
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Hypertension|Primary Aldosteronism
Interventions: DIAGNOSTIC_TEST: 23NaMRI Scan
Sponsor: Jens Titze
Collaborators: Changi General Hospital|Singapore General Hospital|Sengkang General Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-12-27
Completion Date: 2026-08-31
Locations: Singapore General Hospital, Singapore, 169608, Singapore|Duke NUS Medical School, Singapore, 169857, Singapore|Changi General Hospital, Singapore, 529889, Singapore|Sengkang General Hospital, Singapore, 544886, Singapore

Summary:
The study aims to provide quantitative facts on the pathophysiological changes in tissue Na+ content during Na+/K+ redistribution disorders in patients with PA in response to standard therapy. The investigators hypothesize that patients with primary aldosteronism have excessive Na+ storage in the muscle, which can now be quantified non-invasively using 23NaMRI. In analogy to the role of HbA1c as a metabolic long-term marker in diabetes, the quantifiable changes in muscle Na+ content may deliver the data evidence necessary to justify and conduct randomized diagnostic endpoint outcome trials in the future, with the ultimate aim to improve PA detection rate and treatment.

Primary Outcome Measures: Patients with primary aldosteronism have a 10-20% higher muscle Na+ content compared to healthy controls, Difference in muscle Na+ content as measured with 23NaMRI between patients with PA and healthy controls at baseline., Baseline
Secondary Outcome Measures: High K+ intake reduces muscle Na+ in patients with primary aldosteronism, Change in muscle Na+ content as measured with 23NaMRI, 3 months after initiation of K+ supplementation, Baseline to 3 Months|MR blockade reduces muscle Na+ conten in patients with primary aldosteronism, Change in muscle Na+ content as measured with 23NaMRI, 12-18 months after initiation of MR blockade treatment, Baseline to 18 months|Compared to MR blockade, adenoma surgical removal is more efficient in reducing muscle Na+ in patients with primary aldosteronism, Change in muscle Na+ content as measured with 23NaMRI after adenoma surgical removal compared to MR blockade treatment., 36 Months
Promoting Aging in Place Through A Wellness Program
NCT Number: NCT06569576
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Group Meetings|Telehealth
Interventions: BEHAVIORAL: Wellness program
Sponsor: Mercy University
Collaborators: Yeshiva University
Sex: ALL
Age: OLDER_ADULT
Enrollment: 40
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2023-10-07
Completion Date: 2025-12-30
Locations: Mercy University, Dobbs Ferry, New York, 10522, United States

Summary:
Study explores the impact of an eight-week Healthy Aging Wellness (HAW) group-based program delivered online and in-person to improve hope and well-being in community-dwelling older adults.

Primary Outcome Measures: Integrative Hope Scale (IHS), * Self-measure of person's sense of hope
* Scored on a scale ranging from 1 (low) to 6 (high) points
* Total score ranges from 23 to138, up to 8 weeks|Personal Wellbeing Index: 5th Edition, * Self-measure of person's sense of wellbeing
* Scale from 0-10
* higher number indicates greater satisfaction, up to 8 weeks
Secondary Outcome Measures: Open ended interview, Interviewing individuals about their experience in the program, up to 8 weeks
Innervation Characteristics and Determination of Nerve Entry Points of the Musculus Semispinalis Capitis
NCT Number: NCT06569563
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Peripheral Nerve Disease|Muscular Injury
Sponsor: Medipol University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Observational Model: |Time Perspective: p
Start Date: 2018-08-01
Completion Date: 2019-06-14
Locations: Istanbul Medipol University, İstanbul, Kavacık, 34815, Turkey

Summary:
The aim of this study is to determine the innervation characteristics and nerve entry points of the musculus semispinalis capitis. This muscle, which is involved in the extension of the head and neck, is a large and long cervico-thoracic muscle innervated by the dorsal rami of the cervical spinal nerves. The study seeks to enhance the effectiveness of procedures like electromyography (EMG) electrode placement and botulinum toxin injections used for diagnosing and treating conditions related to head and neck pain.

Accurately identifying these nerve entry points is crucial for ensuring the safety and efficacy of treatments, particularly for conditions like cervical dystonia and headaches. While existing studies have focused on the innervation and nerve mapping of various muscles, there has been no specific research on the nerve entry points of the musculus semispinalis capitis. This study aims to provide detailed knowledge of these aspects, offering valuable guidance for interventions in this area.

Primary Outcome Measures: The number of nerves innervating the semispinalis capitis muscle, The semispinalis capitis muscle is innervated by many nerves, primarily the dorsal branches of the cervical spinal nerves. The number of branches of the dorsal branches of the cervical nerves that enter the muscle was determined and counted one by one., 10 months|The location of nerves innervating the semispinalis capitis muscle, In order to determine which cervical nerve branch of the semispinalis capitis muscle was concentrated in which areas of the muscle, the perpendicular distances of the points where the nerves entered the muscle to the determined landmarks were measured and recorded in mm., 10 months|The thickness of nerves innervating the semispinalis capitis muscle, The thickness of the nerves innervating the semispinalis capitis muscle was measured and recorded., 10 months|Mapping of nerves innervating the semispinalis capitis muscle, After detailed information about the nerves innervating the semispinalis capitis muscle and the areas where they are concentrated were determined, the innervation map of the muscle was created. In this way, a muscle-nerve map was created as a guide for clinical applications., 10 months
Comparison of Compounded Topical Anesthetics
NCT Number: NCT06569537
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Procedural Pain
Interventions: DRUG: Lidocaine topical|DRUG: BLT
Sponsor: Dartmouth-Hitchcock Medical Center
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-09
Completion Date: 2026-09
Locations: Dartmouth Hitchcock Dermatology Clinic, Lebanon, New Hampshire, 03766, United States

Summary:
The primary objective for this pilot study is to evaluate the efficacy of the compounded topical anesthetic Benzocaine 20%/ Lidocaine 8%/Tetracaine 4% (BLT) compared to 4% Lidocaine topical in providing relief of pain during IPL, PDL, and microneedling procedures.

Primary Outcome Measures: Pain as measured by the Numeric Pain Rating Scale (NPRS), The NPRS pain scale is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain., At baseline|Pain as measured by the Wong-Baker Face Pain Rating Scale, This scale shows a series of six faces ranging from a happy face at "no hurt" to a crying face at "hurts worst"., At baseline
Predictive Value of NT-proBNP on MACEs After Acute Coronary Syndrome
NCT Number: NCT06569511
Acronym: MACEstdy
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Acute Coronary Syndrome|ST-segment Elevation Myocardial Infarction (STEMI)|Non-ST-Segment Elevation Myocardial Infarction (NSTEMI)|Major Adverse Cardiac Events
Interventions: DIAGNOSTIC_TEST: N-terminal pro-B-type natriuretic peptide (NT-proBNP)|DIAGNOSTIC_TEST: high sensitive cardiac troponin T (hs-cTnT)
Sponsor: Haseki Training and Research Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 241
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-09-01
Completion Date: 2024-03-01
Locations: Haseki Training and Research Hospital, Istanbul, Fatih, 34265, Turkey

Summary:
The role of N-terminal pro-B-type natriuretic peptide (NT-proBNP) as a cardiac biomarker in predicting short-term major adverse cardiovascular events (MACEs) in patients with Acute coronary syndrome (ACS) has been insufficiently reported and remains poorly understood. Additionally, the relationship between NT-proBNP levels and specific ACS subtypes has not been thoroughly examined. Therefore, our study investigated the predictive value of high-sensitivity cardiac troponin (hs-cTn) and NT-proBNP levels on admission for 6-month MACEs in patients who presented to the emergency department (ED) with ACS and subsequently underwent percutaneous coronary intervention (PCI). Furthermore, we sought to evaluate the association between MACEs and specific ACS subtypes.

Primary Outcome Measures: Predictive ability of NT-proBNP for 6-months MACEs, The investigators assessed the effectiveness of N-terminal pro-B-type natriuretic peptide (NT-proBNP) value at admission in predicting 6-months major adverse cardiovascular events (MACEs) in patients with acute coronary syndrome., From admission to 6 months
Secondary Outcome Measures: Incidence of MACEs in STEMI, The investigators assessed the incidence of major adverse cardiovascular events (MACEs) in patients with ST-elevation myocardial infarction (STEMI)., From admission to 6 months|Incidence of MACEs in NSTEMI, The investigators assessed the incidence of major adverse cardiovascular events (MACEs) in patients with non-ST-elevation myocardial infarction (NSTEMI)., From admission to 6 months|Incidence of MACEs in USAP, The investigators assessed the incidence of major adverse cardiovascular events (MACEs) in patients with unstable angina pectoris (USAP)., From admission to 6 months
Clinical Trial of CD19-targeted CAR-T Therapy for Refractory Juvenile Dermatomyositis
NCT Number: NCT06569472
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Juvenile Dermatomyositis
Interventions: BIOLOGICAL: CD19-targetd CAR-T
Sponsor: Chongqing Precision Biotech Co., Ltd
Sex: ALL
Age: CHILD
Enrollment: 10
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-02
Completion Date: 2028-07-31
Locations: Children's Hospital Zhejiang University School of Medicine, Hangzhou, Zhejiang, China

Summary:
This is a Phase I clinical trial to evaluate the efficacy and safety of CD19-targeted CAR-T in the treatment of refractory juvenile dermatomyositis (RJDM).The experiment was divided into two phases: dose exploration (Part A) and dose extension (Part B).

Primary Outcome Measures: To evaluate the safety of CAR-T in the treatment of refractory juvenile dermatomyositis [Safety and Tolerability], The incidence of adverse events after CAR-T cell infusion was assessed by the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 5.0).including the type, frequency and severity of adverse events, 28 days|To evaluate the efficacy of CAR-T in the treatment of refractory juvenile dermatomyositis [Effectiveness], Disease improvement rate: The number of subjects who achieved disease improvement as a percentage of all subjects who received transfusions., 2month,3months|Duration of Response (DOR) of CAR-T treatment in the treatment of refractory juvenile dermatomyositis [Effectiveness], DOR will be assessed from the first assessment of remission to the first assessment of recurrence or progression of the disease or death from any cause, 2 years
Secondary Outcome Measures: AUCS of CD19 CAR-T cells [Cell dynamics], AUCS is defined as the area under the curve in 90 days, 3 months|CMAX of CD19 CAR-T cells [Cell dynamics], CMAX is defined as the highest concentration of CEA CAR-T cells expanded in peripheral blood, 3 months|TMAX of CD19 CAR-T cells[Cell dynamics], TMAX is defined as the time to reach the highest concentration, 3 months
Other Outcome Measures: To evaluate the effects of CD19-targeting CAR T cell preparations on the weight of children, Weight in kilograms were monitored after transfusion until subjects reached 18 years of age, 2 years|To evaluate the effects of CD19-targeting CAR T cell preparations on the height of children, Height in meters were monitored after transfusion until subjects reached 18 years of age, 2 years
Trilaciclib Combined With Concurrent Chemoradiotherapy and Immunotherapy in the Treatment of Esophageal Cancer
NCT Number: NCT06569459
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Esophageal Cancer
Interventions: DRUG: Trilaciclib Injection [Cosela]|DRUG: Placebo
Sponsor: The First Affiliated Hospital with Nanjing Medical University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-07-09
Completion Date: 2026-07-31
Locations: The First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, 210029, China

Summary:
This study is a double-arm, randomized, controlled, single-center, phase II clinical trial aimed at evaluating the efficacy and safety of chemoradiotherapy plus immunotherapy with or without Trilaciclib in the treatment of locally advanced esophageal squamous cell carcinoma that is not resectable.

Primary Outcome Measures: Incidence of grade ≥3 neutropenia, Incidence of grade ≥3 neutropenia, during Trilaciclib plus chemotherapy assessed up to 84 days
Secondary Outcome Measures: Incidence of G-CSF treatment, Incidence of G-CSF treatment, during Trilaciclib plus chemotherapy assessed up to 1 years|Incidence of platelet transfusion, Incidence of platelet transfusion, during Trilaciclib plus chemotherapy assessed up to 1 years|Incidence of grade ≥3 anemia, Incidence of grade ≥3 anemia, during Trilaciclib plus chemotherapy assessed up to 84 days|Incidence of grade ≥3 thrombocytopenia, Incidence of grade ≥3 thrombocytopenia, during Trilaciclib plus chemotherapy assessed up to 84 days
Barriers to Rectal Irrigation in Defaecatory Dysfunction
NCT Number: NCT06569446
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Defecation Disorder|Constipation - Functional|Constipation by Outlet Obstruction|Faecal Incontinence|Faecal Smearing|Obstructive Defecation Syndrome
Interventions: OTHER: There is no intervention. This a qualitative study to explore barriers to rectal irrigation
Sponsor: Guy's and St Thomas' NHS Foundation Trust
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 34
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-10
Completion Date: 2025-02

Summary:
Rectal irrigation is the introduction of warm tap water through the anal canal into the rectum to initiate defaecation. NICE recommends that rectal irrigation be considered in patients with constipation(1) and faecal incontinence (2) refractory to conservative measures such as lifestyle advice and pharmacological therapy, and bio-feedback therapy which is a treatment to help patients learn to strengthen or relax their pelvic floor muscles to improve bowel or bladder function by retraining the pelvic floor muscles and provides psychosocial support(3). Studies have shown that up to half patients discontinue rectal irrigation within a year of commencing therapy (4) (5). The investigators want to understand barriers to rectal irrigation by conducting focused group sessions and cognitive interviews of patients who have used or declined rectal irrigation.

Primary Outcome Measures: Barriers to rectal irrigation, To understand the barriers to rectal irrigation in patients with defaecatory dysfunction by conducting focused group sessions., 60 minutes
Secondary Outcome Measures: Validate barriers to rectal irrigation, To validate the barriers discovered during focused group sessions by conducting cognitive interviews., 60 minutes
Efficacy of Therapeutic Exercise Compared to Femoral Nerve Mobilisation in Knee Tendinosis
NCT Number: NCT06569433
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Chronic Patellar Tendinopathy
Interventions: PROCEDURE: THERAPEUTIC EXERCISE AND MOBILISATION OF THE FEMORAL NERVE
Sponsor: University of Alcala
Sex: ALL
Age: ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-08-20
Completion Date: 2024-12-20

Summary:
Tendons, located between muscle and bone, transmit force from the former to the latter, allowing joint movement. They are composed mainly of collagen, elastin and water, and are divided into three zones: osteotendinous junction (tendon-bone), myotendinous junction (muscle-tendon) and the tendon body.

Knee tendinosis is a pathology that affects the tendons of this joint due to the breakdown of collagen in the tendon body, characterised by pain during and after exercise, inflammation and loss of function. It is common in athletes, especially in jumping sports such as basketball and volleyball, due to repetitive strain, injury or ageing. Factors such as weight, leg length and muscle strength can influence its development. Radiologically, patellar tendon thickening, and abnormalities are seen.

Treatment includes eccentric exercises, shock wave therapy, ultrasound-guided sclerosis, anti-inflammatory drugs, plasma injections and aprotinin. Neurodynamic theory suggests that altered mechanosensitivity of the femoral nerve may contribute to knee pain, and neurodynamic techniques can improve nerve mobility and reduce symptoms.

A strength exercise with isometric contractions can decrease pain for up to 45 minutes, being a therapeutic option for patellar tendinopathy without affecting muscle strength.

The research project presented in the master's thesis aims to compare the effectiveness of femoral nerve mobilisation and therapeutic exercise in the treatment of knee tendinosis.

Primary Outcome Measures: The 'pain' variable, The variable 'pain' is subjective and qualitative and is measured quantitatively to facilitate its analysis. In this case the Visual Analogue Scale (VAS) will be used, which facilitates the subjective evaluation of the intensity of the pain that the patient experiences, through a score based on their perception of pain, It ranges from 0 (being the lowest score therefore there is no pain) to 10 (being the highest score therefore it is at its maximum pain level), 6 weeks|functionality (VISA-P questionnaire), the VISA-P questionnaire which allows us to classify tendinopathy according to the severity of the symptoms and the functional capacity of the patients., 6 weeks
Study Of Comparing SAF-189s With Crizotinib In First Line ALK-Positive Advanced and Metastatic NSCLC
NCT Number: NCT06569420
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Non-Small Cell Lung Cancer|ALK-positive|SAF-189s
Interventions: OTHER: Drug: Foritinib Succinate|OTHER: Drug: Crizotinib
Sponsor: Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 275
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2021-12-31
Completion Date: 2027-12-31
Locations: Shanghai Pulmonary Hospital, Shanghai, China

Summary:
This randomized, multicenter, Phase III, open-label study will evaluate the efficacy and safety of SAF-189s versus crizotinib treatment in participants with treatment-naive ALK-positive advanced NSCLC. Participants will be randomized 1:1 into one of the two treatment groups to receive either SAF-189s (160 milligrams \[mg\] once daily \[QD\]) or crizotinib (250 mg BID) orally, respectively.

Primary Outcome Measures: Progression-free survival (PFS) by IRC, as determined by IRC based on RECIST 1.1 criteria., up to 36 months|Overall survival (OS), Time in months from date of randomization to death due to any cause, up to 60 months|Progression-free survival (PFS) by INV, as determined by INV based on RECIST 1.1 criteria., up to 36 months|Objective Response Rate (ORR) by IRC and INV, Percentage of Participants With Objective Response Rate (ORR) of Complete Response (CR) or Partial Response (PR) as Determined by Investigators and IRC According to RECIST V1.1 Criteria, up to 36 months|Duration of response (DOR) by IRC and INV, Duration of response defined as time from when response was first documented until first documented disease progression or death, whichever occurs first., up to 36 months|to evaluate the C-ORR in patient with CNS metastases., up to 36 months|to assess the C-TTR in patient who have as CNS objective response, up to 36 months|to assess the C-DOR in patient who have as CNS objective response., up to 36 months|to assess the C-TTP in patient who have as CNS objective response., up to 36 months|The time to CNS progression in ITT by IRC., To evaluate the time to CNS progression in ITT by IRC., up to 36 months|Incidence of adverse events., up to 36 months|Health-Related Quality of Life (HRQoL) by EORTC Quality of Life Questionnaire C30 Score, All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a better level in functional scales/items and Global health status, or worse level in symptom scales/items., up to 36 months|Health-Related Quality of Life (HRQoL) by EORTC Quality of Life Questionnaire LC13 Score, All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a worse level in symptom scales/items, such as in cough, short breath, chest pain, and other symptoms associated with lung cancer., up to 36 months
A Randomized, Placebo Controlled Study of Cannabidiol in Young Adult Cannabis Users
NCT Number: NCT06569394
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Cannabis Use Disorder
Interventions: DRUG: Broad Spectrum Cannabidiol (bsCBD) 400 mg|DRUG: Placebo
Sponsor: University of Colorado, Denver
Collaborators: National Institute on Drug Abuse (NIDA)
Sex: ALL
Age: ADULT
Enrollment: 200
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: OTHER
Start Date: 2024-08
Completion Date: 2028-06-30
Locations: University of Colorado Anschutz Medical Campus, Aurora, Colorado, 80045, United States

Summary:
We will study the harm-reducing effect of hemp-derived CBD in non-treatment-seeking emerging adults who use cannabis regularly. The study will use our novel naturalistic cannabis administration approach, which examines ecologically valid cannabis use utilizing a mobile lab setting to assess the effects of the cannabis products the participants regularly use. We will recruit a sample of emerging adults, half of whom primarily use flower products and half of whom primarily use concentrate products. Individuals will be randomly assigned to hemp-derived CBD or placebo.

Primary Outcome Measures: Difference in blood THC-COOH levels, THC-COOH levels in blood samples collected at baseline, Week 4, and Week 8 of medication ingestion., 8 weeks|Difference in blood THC levels, THC levels in blood samples collected before and after cannabis use at baseline, Week 4, and Week 8 of medication ingestion., 1 hour pre and post THC self-administration at baseline, 4 weeks, and 8 weeks|Difference in cannabis use, Total number of days of cannabis use during the 8-week medication period as reported on daily diaries., 8 Weeks
Other Outcome Measures: Adverse effects, Adverse effects reported at Week 4 and Week 8 of medication ingestion, 8 weeks|Difference in blood CBD levels, CBD levels in blood samples collected at Week 4 and Week 8 of medication ingestion, 8 weeks
A Phase II Trial Utilizing Metronidazole to Optimize the Microbiome of Rectal Adenocarcinoma Undergoing Neoadjuvant Therapy
NCT Number: NCT06569368
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Rectal Adenocarcinoma
Interventions: DRUG: Metronidazole
Sponsor: M.D. Anderson Cancer Center
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2014-07-10
Completion Date: 2026-10-31
Locations: MD Anderson Cancer Center, Houston, Texas, 77030, United States

Summary:
To learn if adding metronidazole to standard therapy can decrease populations of Fusobacterium nucleatum (F. nucleatum) and other anaerobes (small organisms that cause infections) in participants with rectal cancer receiving neoadjuvant therapy, compared to neoadjuvant therapy alone.

Primary Outcome Measures: Safety and adverse events (AEs), Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0, Through study completion; an average of 1 year.
A Study to Evaluate the Efficacy and Safety of VCT220 in Obesity Chinese Population
NCT Number: NCT06569355
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Obesity|Overweight
Sponsor: Vincentage Pharma Co., Ltd
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 250
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2023-12-27
Completion Date: 2024-08-01

Summary:
The goal of the study is to assess how VCT220 tablets affect the bodyweight when used once daily in obese or overweight adult participants

Qualified participants will be randomly assigned to one of four groups using a computerized system. Participants will get VCT220 or placebo tablets for 16 weeks and will need to take tablets each morning.

Participants will have 7 clinic visits and a final follow-up visit approximately 14 days after the last study intervention administration.

Primary Outcome Measures: Percentage change in body weight, percentage-point, From baseline (week 1) to week 16
Secondary Outcome Measures: Proportion of subjects with weight decrease ≥ 5%, percentage-point, From baseline (week 1) to week 16|Absolute change in body weight, measured in kg, From baseline (week 1) to week 16|Absolute change in body mass index (BMI), measured in kg/m\^2, From baseline (week 1) to week 16|Absolute change in waist circumference, measured in cm, From baseline (week 1) to week 16|Change in blood lipid profiles (TC, TG, LDL-C, and HDL-C), measured in mmol/L, From baseline (week 1) to week 16|Change in fasting plasma glucose (FPG), measured in mmol/L, From baseline (week 1) to week 16|Change in HbA1c (glycated haemoglobin), percentage-point, From baseline (week 1) to week 16|Change in fasting insulin, measured in μIU/mL, From baseline (week 1) to week 16|Change in fasting C-peptide, measured in ng/ml, From baseline (week 1) to week 16
Other Outcome Measures: Adverse events, including treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), Count of events, From baseline (week 1) to week 18|PK analysis-Minimum concentration, measured in ng/ml, From week 1 to week 12|PK analysis-Maximum concentration, measured in ng/ml, From week 1 to week 12|PK analysis-Time to maximum concentration, measured in hour, From week 1 to week 12|PK analysis-Area under the concentration-time curve, measured in h∙ng/mL, From week 1 to week 12
Botulinum Neurotoxin Type A (BoNT-A) in Paediatric Non-neurogenic Therapy Resistant Overactive Bladder (OAB)
NCT Number: NCT06569342
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Overactive Bladder|Incontinence, Daytime Urinary|Incontinence, Nighttime Urinary
Interventions: PROCEDURE: Intradetrusor BoNT-A
Sponsor: University of Aarhus
Sex: ALL
Age: CHILD
Enrollment: 43
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-01-15
Completion Date: 2022-06-15
Locations: Aarhus University Hospiral, Aarhus, Region Midt, 8200, Denmark

Summary:
A non-intervention cohort study on the use of Botulinum Neurotoxin Type A (BoNT-A) in Paediatric Non-neurogenic Therapy Resistant Overactive Bladder (OAB). Primary endpoint was the reduction of urinary incontinence.

Primary Outcome Measures: Incontinence episodes, Change of incontinence episodes, 1 month after treatment until request for additional treatment (up to 12 months)
Secondary Outcome Measures: Response, Identification of predictors of response, 1 month after treatment until request for additional treatment (up to 12 months)|Side effects, Identification of predictors of side effects, 1 month after treatment
Bacterial Reduction After Supplementary Disinfection Procedures in Infected Root Canals
NCT Number: NCT06569329
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Dental Pulp Necroses
Interventions: DEVICE: GentleWave System Root Canal Therapy|DEVICE: EdgePro Laser Root Canal Therapy|DEVICE: The ProUltra Piezo Ultrasonic with EndoUltra Tips Root Canal Therapy
Sponsor: Abhishek Parolia
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 90
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-08-20
Completion Date: 2026-08
Locations: University of Iowa College of Dentistry and Dental Clinics, Iowa City, Iowa, 52242, United States

Summary:
The purpose of this study is to understand the effect that 3 different types of root canal procedures have on bacteria.

Primary Outcome Measures: Assessment of the changes in the bacterial count at various time points during the root canal procedure., Sterile paper points will be inserted into the root canal in order to collect bacteria. Real-time Polymerase Chain Reaction will be used to assess the bacterial counts., Baseline (pre-intervention) and during the intervention and immediately after the intervention
Genetic Testing for the Prevention of Cancer in Indigenous American Communities (JUNIPER Trial)
NCT Number: NCT06569316
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Hematopoietic and Lymphatic System Neoplasm|Malignant Solid Neoplasm
Interventions: PROCEDURE: Biospecimen Collection|OTHER: Communication Intervention|OTHER: Genetic Testing|OTHER: Survey Administration
Sponsor: Mayo Clinic
Collaborators: National Cancer Institute (NCI)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 300
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SCREENING
Start Date: 2024-09-30
Completion Date: 2027-08-31
Locations: Mayo Clinic in Arizona, Scottsdale, Arizona, 85259, United States

Summary:
This clinical trial is studying the genetic changes in cells associated with different types of cancer in Indigenous American (IA) populations in the Southwest to improve cancer screening, precision prevention, and therapeutic intervention for individual in these communities. IA tribes have much lower rates of cancer screening, have more limited access to healthcare, are more often diagnosed at later stages of disease, and have the poorest outcomes in all types of cancer when compared to any other racial and ethnic group in the United States. Due to these significant cancer health disparities, IAs have been understudied and little is known about the molecular characterization of tumors arising in IAs. Undergoing genetic testing of tumors may improve cancer outcomes in IA participants and communities.

Primary Outcome Measures: Successful accrual of Indigenous American (IA) participants, Assessed by the number of IA participants consented to study., Up to 5 years|Return of valuable genetic results to participants, Assessed by the number of participants who receive genetic results. Clinically useful genomic data will be returned to participants with navigation to counseling and clinical resources as warranted and as they select., Up to 5 years
Adverse Neonatal Outcomes With a Shortened Clinical Regimen of Dexamethasone.
NCT Number: NCT06569251
Acronym: UNODEXA
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Preterm Birth|Distress Respiratory Syndrome
Interventions: DRUG: Dexamethasone 12 mg QD|DRUG: Dexamethasone 6 mg BID
Sponsor: Ricardo A Gutierrez Ramirez, MD, MSc, FACOG
Sex: FEMALE
Age: ADULT
Enrollment: 70
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-03-01
Completion Date: 2024-11-30
Locations: Hospital Escuela, Tegucigalpa, Francisco Morazan, 11101, Honduras

Summary:
Respiratory morbidity, including respiratory distress syndrome (RDS), is a serious complication of preterm birth and the leading cause of early neonatal mortality and disability. The effects of antenatal corticosteroid administration on fetal lung maturation have been widely studied in order to counteract such adverse perinatal outcomes of preterm birth. The dexamethasone regimen will be evaluated at different administration frequencies, but at the same total dose. The hypothesis is: The type of dexamethasone regimen administered for fetal lung maturation influences the incidence of perinatal complications.

Primary Outcome Measures: neonatal complications, Presence or absence of respiratory distress syndrome, necrotizing enterocolitis, intraventricular hemorrhage, cystic ventricular leukomalacia, or death after receiving any of the different antenatal corticosteroid regimens, from the first intervention to Newborn discharge. on average less than 28 days
Secondary Outcome Measures: Maternal complications, Signs of maternal or neonatal infection determined clinically and laboratory after administration of corticosteroids. Maternal hyperglycemia or arterial hypertension. Fetal hypoglycemia., rom the first intervention to birth. on average less than 28 days
Diabetic Foot Ulcer (DFU) Rapid Pathogen Identification
NCT Number: NCT06569238
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Diabetic Foot Ulcer|Diabetes Mellitus|Wound
Interventions: DIAGNOSTIC_TEST: Conventional bacterial culture|DEVICE: Rapid diagnostic group using mNGS technology
Sponsor: University of Michigan
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 44
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2024-09
Completion Date: 2025-09
Locations: University of Michigan, Ann Arbor, Michigan, 48109, United States

Summary:
The purpose of this study is to evaluate the role of rapid diagnosis of pathogens in treatment of infection and wound healing in diabetic foot ulcers. This research is studying the use of a new device of people to learn if metagenomic next generation sequencing (mNGS) techniques technology is a feasible tool that can be used to direct targeted antibiotic therapy in infected diabetic foot ulcers.

Participant's tissue will be randomized to usual care tissue collection and cultures (standard of care) or usual care tissue collection and cultures (standard of care) plus metagenomics next generation sequencing (mNGS). The participant's will not be randomized to any treatment (i.e. antibiotic therapy).

Primary Outcome Measures: The percent change in foot ulcer surface area square centimeter (cm2) after 12 weeks of observation for infected diabetic foot ulcers, Baseline, 12 weeks
Secondary Outcome Measures: Percent of clinical resolved infected DFU for infected DFU participants with clinically resolved infection defined as improvement of greater or equal to two clinical signs of infection, Clinical signs of infection includes: local swelling or induration, erythema, local tenderness or pain, local warmth, purulent discharge) with no requirement for additional antibiotics upon follow-up appointments., Baseline up to 12 weeks|Total days of antibiotic therapy for the infected DFU participants, Baseline up to 12 weeks|Number of days to infection resolution for the infected DFU participants, Baseline up to 12 weeks|The percentage of participants with an infected DFU at baseline that resolve clinical infection by study week 4, Baseline to 4 weeks|The percentage of participants with an infected DFU at baseline that undergo a non-traumatic lower extremity amputation during the study., Baseline up to 12 weeks|The percentage of participants with an infected DFU at baseline that are hospitalized for infection during the study., Baseline up to 12 weeks|Post study percentage change of wound surface area (cm2)., Baseline up to 12 weeks|Proportion of participants that reach a 50% reduction in surface area (cm2) of the infected DFU, Baseline up to 12 weeks
Gemcitabine/Cisplatin/Nab-Paclitaxel and Rilvegostomig in Resectable iCCA
NCT Number: NCT06569225
Acronym: NEOLANGIO
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Cholangiocarcinoma Resectable
Interventions: DRUG: Gemcitabine/Cisplatin/Nab-Paclitaxel and Rilvegostomig
Sponsor: University Health Network, Toronto
Collaborators: Sunnybrook Health Sciences Centre|Hamilton Health Sciences Corporation
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-12-15
Completion Date: 2028-12-31
Locations: University Health Network, Toronto General Hospital, Toronto, Ontario, M5G 2C4, Canada

Summary:
Biliary tract cancer is a highly aggressive and heterogeneous group of gastrointestinal cancers that arise from the intra- or extrahepatic bile ducts (CCA), or the gallbladder (GBC)(1-3). While it accounts for only 0.7% of all malignant tumors and 3% of all gastrointestinal malignancies in adults, both incidence and mortality are increasing. Biliary tract cancers usually present at an advanced stage, with only approximately 20% of patients being diagnosed with an early-stage disease (1, 2, 4). There is a high risk of recurrence post curative radical resection, with 60-70% of patients recurring within 5 years, with 5-year survival of around 25% (1, 2, 5). There is evidence for use of adjuvant chemotherapy with fluoropyrimidine- based regimens as per the BILCAP and ASCOT phase III trials \[(5-7).However, despite advances in adjuvant treatment, recurrence rates after resection of BTC remain high even with adjuvant chemotherapy. For example, in the BILCAP study, 5-year RFS was reported as 33.9% (95% CI: 27.6 to 40.2) (1). Therefore, an unmet need exists to optimize peri-operative treatment to reduce recurrence and improve outcomes in patients with resectable BTC.

Primary Outcome Measures: Major pathological response (MPR), defined as >70% tumor necrosis, To determine pathological response rate to neoadjuvant Gemcitabine/Cisplatin/Nab-Paclitaxel and Rilvegostomig in resected tumour, 2 years
Secondary Outcome Measures: Objective response rate (ORR), To determine the radiologic objective response rate (ORR) to neoadjuvant Gemcitabine/Cisplatin/Nab-Paclitaxel and Rilvegostomig., 3 years|The number of patients who experience a surgical delay and/or drop off due to treatment related adverse events (TRAEs) or progressive disease, To assess feasibility of pre-operative treatment of Gemcitabine/Cisplatin/Nab-Paclitaxel and Rilvegostomig, 2 years|The number of ≥ grade 3 adverse events (AEs) or immune related adverse events that occur during treatment, To assess safety of pre-operative treatment with Gemcitabine/Cisplatin/Nab-Paclitaxel and Rilvegostomig., 3 years|Rate of R0, Number of resections with negative margins, 2 years
Beta-1 Adrenergic Inhibition to Reduce Cardiac Injury and Inflammation After Subarachnoid Hemorrhage (BADCATS)
NCT Number: NCT06569212
Acronym: BADCATS
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Non-Traumatic Subarachnoid Hemorrhage
Interventions: DRUG: Metoprolol|DRUG: Placebo
Sponsor: Madeleine Puissant
Collaborators: MaineHealth
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2029-09

Summary:
To determine the effect of early metoprolol administration after non-traumatic subarachnoid hemorrhage (SAH).

Primary Outcome Measures: Delta QTc length, Change (Delta) QTc length between intervention and control groups., 7 days|Delta neutrophil activity, Delta neutrophil activity between intervention and control groups., 7 days
Secondary Outcome Measures: Adverse events, Including but not limited to symptomatic bradycardia, symptomatic hypotension, or complete heart block, 7-days|Number of patients with evidence of cardiac injury, Measurement of troponin levels, echocardiograph, 7-days|Need for Vasopressors, Any documented intravenous vasoactive medication administration, 7-days|Sympathetic Nervous System (SNS) Activity, Catecholamine Measurements, 7-days|Neutrophil Activity, Measurement of neutrophils in CSF and serum samples, 7 days|Evidence of Clinical Vasospasm, Evidence of clinical vasospasm, Up to 15-weeks|ICU Length of Stay (LOS), Number of full days, Up to 15-weeks|Hospital Length of Stay (LOS), Number of full days, Up to 15-weeks|In-hospital mortality, Whether patient died during during sentinel hospitalization, Up to 15-weeks
Cue-Based Vs. Clinician-Driven Feeding in Very Low Birthweight Infants
NCT Number: NCT06569186
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Infant, Very Low Birth Weight|Infant Development|Feeding Patterns
Interventions: BEHAVIORAL: Cue-based feedings
Sponsor: University of Alabama at Birmingham
Sex: ALL
Age: CHILD
Enrollment: 74
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2025-10

Summary:
In this parallel-group randomized controlled trial, very low birthweight infants will be randomly assigned in a 1:1 ratio to either cue-based (intervention group) or clinician-driven feeding (control group). For infants in the intervention group, Speech therapists and nurses will use their cue-based assessment training to aid in clinical management of oral feeding. For infants in the control group, clinicians caring for these infants will define the feeding plan based on their daily assessment.

Primary Outcome Measures: Time interval in days from introduction to attainment of independent oral feeding, 4-20 days
Secondary Outcome Measures: Postnatal age at discharge in days, 34 to 40 weeks postnatal age|Length of hospital stay in days, 10-60 days|Average weight gain during the transition from tube to oral feeding, 10-60 days|Total number of tube feeding events per infant during the transition from tube to oral feeding, 10-60 days|Follow up phone call, A follow-up phone call 3 months after NICU discharge will also be performed to assess long-term outcomes including the need for tube feeding or hospitalizations related to feeding/nutrition problems., 4-6 months after birth