pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Chemopreventive Effect of Combination of Celecoxib and Metformin in Patients With Familial Adenomatous Polyposis
NCT Number: NCT06545526
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Familial Adenomatous Polyposis
Interventions: DRUG: celecoxib monotherapy|DRUG: celecoxib and metformin combination
Sponsor: Yonsei University
Sex: ALL
Age: ADULT
Enrollment: 28
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-08-13
Completion Date: 2026-06-30
Locations: Department of Internal Medicine, Yonsei University College of Medicine, Seoul, 120-752, Korea, Republic of

Summary:
Familial adenomatous polyposis (FAP) leads to adenomas and eventual adenocarcinomas in colon and less frequently, duodenum. Chemopreventive strategies have been studied in FAP patients to delay the development of adenomas and cancers. The non-steroidal anti-inflammatory drugs (NSAIDs) and selective cyclooxygenase-2 inhibitor have shown the regression of colorectal and duodenal adenomas in FAP patients. However, these drugs showed gastrointestinal damage and cardiovascular risks, and new preventive strategies are needed. Metformin, an anti-diabetic drug, has recently been suggested to have a suppressive effect on tumorigenesis via inhibition of mTOR pathway, and have an inhibitory effect on polyp recurrence after removal of sporadic colorectal polyps. In addition, metformin has a number of potential mechnisms of carciovascular bebefit. We devised a randomized, open-label, comparative study to evaluate the effect of combination of celecoxib and metformin on polyps of colorectum and duodenum in FAP patients.

Primary Outcome Measures: Mean percentage change of the number and size of polyps in colon and/or duodenum., At the base-line endoscopy (colonoscopy and upper gastrointestinal endoscopy), india-ink tattoo will be placed in the ascending colon, sigmoid colon/rectum, and duodenum. In case of patient with retained rectum after colectomy and ileorectal anastomosis, sigmoidoscopy will be peformed. The base-line and six-month endoscopic examination will be recorded, and photographs will be taken at the tattoo-marked area and used for measurements of the number and size of polyps. The diameter of a polyp will be measured with the aid of biopsy forceps included in the photographic field, and only distinct polyps at least 2 mm in diameter will be counted., After six-month administration of celecoxib monotherapy or combination of celecoxib and metformin
Secondary Outcome Measures: A qualitative assessment of the total extent of colorectal and duodenal polyposis, A qualitative assessment of the total extent of colorectal polyposis will be conducted via video review(at base line and month 6) by two endoscopists experienced in the management of FAP, and scored as the same as, better than, or worse than base-line endoscopic findings, without the endoscopists' being aware of treatment group., After six-month administration of celecoxib monotherapy or combination of celecoxib and metformin
Depression and Anxiety Among Chronic Pain Patients in the Netherlands
NCT Number: NCT06545513
Status: ACTIVE_NOT_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Chronic Pain|Depression, Anxiety
Sponsor: Amsterdam UMC, location VUmc
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 10000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-06-30
Completion Date: 2024-10
Locations: Amsterdam UMC, Amsterdam, Noord Holland, 1081HV, Netherlands

Summary:
The goal of this observational study is to determine the prevalence of depression among patients with chronic pain in the Netherlands. The main questions it aims to answer are:

* How often does depression and/or anxiety occur among patients with chronic pain.
* The relationship between pain, depression and sociodemographic factors.
* The effect of pain and depression on the quality of life.

Participants have completed questionnaires during their treatment at the chronic pain outpatient clinic. Therefore the patients do not have to complete any new questionnaires. Informed consent for participation in the study was asked during visit at the outpatient clinic or via a letter of objection.

Primary Outcome Measures: Prevalence of anxiety, prevalence of anxiety among chronic pain patients, 2019-2022|Prevalence of depression, prevalence of depression among chronic pain patients, 2019-2022
Secondary Outcome Measures: Quality of life, correlation between chronic pain, depression and anxiety, 2019-2022
A Phase IIb Study of Glycopyrrolate Inhalation Solution Over 1 Week in Subjects With COPD
NCT Number: NCT06545500
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Chronic Obstructive Pulmonary Disease
Interventions: DRUG: Glycopyrrolate (85 μg)|DRUG: Glycopyrrolate (42.5 μg)|DRUG: Glycopyrrolate (14 μg)|DRUG: Placebo
Sponsor: Verona Pharma plc
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2024-12
Locations: Clinical Research of West Florida Inc - Clearwater, Clearwater, Florida, 33765, United States|Clinical Research of West Florida Inc - Tampa, Tampa, Florida, 33606, United States|Midwest Chest Consultants PC, Saint Charles, Missouri, 63301, United States|American Health Research Inc, Charlotte, North Carolina, 28277, United States

Summary:
This study is a randomized, double-blind, placebo-controlled complete block cross-over study designed to assess the efficacy, safety, and pharmacokinetics of 3 dose levels of glycopyrrolate inhalation solution delivered twice daily via standard jet nebulizer over three 1-week active treatment periods and one 1-week placebo period in subjects with chronic obstructive pulmonary disease (COPD).

Primary Outcome Measures: Change from average baseline in morning trough forced expiratory volume in 1 second (FEV1), Baseline and Day 7
Secondary Outcome Measures: Change from average baseline FEV1 to average peak FEV1 measured over 4 hours, Baseline and Day 7|Change from average baseline FEV1 to average FEV1 area under the curve versus time from time 0 to 4 hours (AUC0-4h), Baseline and Day 7|Change from average baseline FEV1 to average FEV1 area under the curve versus time from time 0 to 12 hours (AUC0-12h), Baseline and Day 7|Change from average baseline FEV1 to evening trough FEV1, Baseline and Day 7|Change from average baseline FEV1 to peak FEV1 measured over 4 hours after first dose, Baseline and Day 1|Change from average baseline FEV1 to average FEV1 AUC0-4h measured after first dose, Baseline and Day 1|Incidence of treatment emergent adverse events (TEAEs), From first dose through the follow-up contact (approximately 8 weeks)|Glycopyrronium free base AUC0-12h, Day 7|Glycopyrronium free base maximum plasma drug concentration (Cmax), Day 7|Glycopyrronium free base time to maximum plasma drug concentration (tmax), Day 7
Prediction Model of Hip Fragility Fracture Realistic Data From a Traumatology Department and Orthogeriatric Ward.
NCT Number: NCT06545487
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Osteoporosis Risk|Fracture of Femur|Fragility
Interventions: OTHER: BLOOD SAMPLE
Sponsor: Universidad de Valparaiso
Collaborators: HOSPITAL DOCTOR GUSTAVO FRICKE|Centro Interdisciplinario para el Desarrollo del Adulto Mayor Gerópolis
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-03-05
Completion Date: 2024-04-09
Locations: Universidad de Valparaíso, Valparaíso, Chile

Summary:
The aim of the project is to build a prediction model of hip fragility fracture using hospital data routinely collected in the traumatology department from the last 12 years and up to date Explainable Artificial Intelligence (XAI) tools. This model should be adapted to the "real world" conditions of the region and predict clinical data such as risk of fracture and refracture, mortality risk, fracture type classification and the generation of a specific comorbidity index.

Primary Outcome Measures: Comparison between parameters intra-groups, Analysis of data extracted from blood samples comparing data in control and fractured group separatedly, 2023-2024|Comparison between parameters inter-groups, Analysis of data extracted from blood samples comparing data in control and fractured groups, 2023-2024
Effects of rTMS Compared to SSRI as Early Treatment of Depression (Early-TMS)
NCT Number: NCT06545474
Acronym: Early-TMS
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Major Depressive Disorder
Interventions: DEVICE: bilateral theta burst stimulation|DRUG: SSRI treatment
Sponsor: University Hospital Tuebingen
Collaborators: German Center for Mental Health (DZPG; www.dzpg.org)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 106
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-15
Completion Date: 2026-12-31

Summary:
The aim of this randomized multicentre phase 2 clinical trial is to compare the effects of rTMS and SSRI medication as early treatment of depression. In this two-stage, therapy response-adapted trial, 106 patients suffering from non-treatment resistant major depression (non-TR MD) will be randomized in Stage I to either 4 weeks bilateral theta burst stimulation (TBS) or 4 weeks antidepressant SSRI medication. The allocation to Stage II occurs therapy response-adapted. Patients receive either a maintenance treatment or a switch to the respective other treatment arm. The primary outcome is the comparison of the two study arms with regard to therapy response measured with the Montgomery-Asberg Depression Rating Scale (MADRS) after 4 weeks at the end of Stage I.

Primary Outcome Measures: response rates after Stage I, The primary endpoint is the comparison of the two study arms with regard to the number of participants achieving therapy response (reduction of MADRS score ≥ 50%) after 4 weeks at the end of Stage I., 4 weeks
Appropriateness of Angioplasty in Patients With Chronic Coronary Syndromes
NCT Number: NCT06545448
Acronym: RIGHT-PCI
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Coronary Artery Disease|Angina Pectoris
Interventions: PROCEDURE: Percutaneous Coronary Intervention (PCI)
Sponsor: University of Sao Paulo General Hospital
Collaborators: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1875
Study Design: Observational Model: |Time Perspective: p
Start Date: 2017-12-01
Completion Date: 2025-12-31
Locations: Heart Institute (InCor-HCFMUSP), São Paulo, SP, 05403000, Brazil

Summary:
Percutaneous coronary intervention (PCI) has dramatically changed the treatment of obstructive coronary artery disease patients. PCI is indicated in patients with chronic coronary syndrome (CCS) symptoms unresponsive to optimized medical therapy. The American College of Cardiology Foundation and partners developed in 2009 - and updated them in May 2017 - the appropriateness criteria for PCI to support the rational use of PCI in chronic patients and to provide patients with high-quality cardiovascular care. Since then, these criteria have been applied to guide physicians and serve as metrics of the quality of care based on the best available scientific evidence. Countries like the United States and Japan already have robust studies on the topic with important repercussions on clinical practice. In Brazil, to date, there are no studies on the adequacy of PCIs in patients with CCS.

Primary Outcome Measures: Determine the rates of elective PCI classified as appropriate, possibly appropriate, or rarely appropriate., Determine the rates of elective PCI classified as appropriate, possibly appropriate, or rarely appropriate based on the Appropriateness Criteria proposed by the ACC / AHA in 2017., Immediately following the procedure
Secondary Outcome Measures: Incidence of the composite endpoint of all-cause mortality and non-fatal cardiovascular events (myocardial infarction, periprocedural stroke, or the need for new revascularization), Incidence of the composite endpoint of all-cause mortality and non-fatal cardiovascular events (myocardial infarction based on the 4th Universal Definition of MI, periprocedural stroke occurring during the hospitalization index, or the need for new revascularization either by CABG or PCI), 12 months after the procedure index|Incidence of persistent or recurrent post-PCI angina or new onset/worsening heart failure, Incidence of persistent or recurrent post-PCI angina or new onset/worsening heart failure both clinically manifest, 12 months after the procedure index
Other Outcome Measures: Clinical and sociodemographic predictors of rarely appropriate elective PCI, Clinical and sociodemographic predictors of rarely appropriate elective PCI, Immediately following the procedure
Effect of St. John's Wort Oil on Skin Moisture in Intensive Care Patients
NCT Number: NCT06545422
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Skin Moisture
Interventions: OTHER: St. John's wort oil|OTHER: Barrier Cream
Sponsor: Eskisehir Osmangazi University
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 140
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2023-09-01
Completion Date: 2024-03-01
Locations: Ayşenur ÖZENÇ KOLUTEK, Eskişehir, Turkey

Summary:
The study was conducted to evaluate the effect of St. John's wort oil application on skin moisture in intensive care patients. The study is a prospective pre-test-post-test controlled experimental research.It has been observed that St. John's wort oil has an effect on the skin moisture of intensive care patients.

Primary Outcome Measures: Experimental Group Results, Moisture measurement of the coccyx area was performed with a skin moisture meter., Measurements were made every day from day 0 to day 20. Measurements were made every day from day 0 to day 20.|Control Group Results, Moisture measurement of the coccyx area was performed with a skin moisture meter., Measurements were made every day from day 0 to day 20. Measurements were made every day from day 0 to day 20.
Serratus Posterior Superior Intercostal Plane Block in Robotic-Assisted Thymectomy
NCT Number: NCT06545409
Acronym: SPRATS
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: RATS Surgery|Thymectomy|Locoregional Anesthesia|Postoperative Pain Management|Serratus Posterior Superior Intercostal Plane Block|Robotic-Assisted Thoracoscopic Surgery
Interventions: PROCEDURE: Ultrasound-guided Serratus Posterior Superior Intercostal Plane Block performed with 0.25% bupivacaine|PROCEDURE: Ultrasound-guided Serratus Posterior Superior Intercostal Plane Block performed with a placebo solution (0.9% NaCl)
Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 28
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-15
Completion Date: 2026-09-15

Summary:
This study aims to assess the effectiveness of the Serratus Posterior Superior Intercostal Plane Block (SPSIP Block) for postoperative pain control, reducing opioid analgesic consumption, minimizing postoperative respiratory complications, and enhancing patient satisfaction (measured using the QoR-15 index) in patients undergoing robotic thymectomy, compared to patients who do not receive the block.

Primary Outcome Measures: Postoperative pain intensity, The measurement of postoperative pain intensity, assessed using the Numeric Pain Rating Scale (NPRS), a numerical scale that can range from 0 to 10 (where 0 means no pain and 10 corresponds to the worst imaginable pain), in the two study groups., 0, 2, 6, 12, and 24 hours after the end of the surgical procedure
Secondary Outcome Measures: Total opioid drug consumption, The total number of opioid doses administered via a Patient Controlled Analgesia (PCA) device in the first 24 hours after surgery, 24 hours after surgery|Consumption of rescue analgesics, The total dose of acetaminophen administered upon the patient's request during the first 24 postoperative hours, 24 hours after surgery|postoperative respiratory complications, The number of any postoperative respiratory complications in the two study groups, 24 hours after surgery|postoperative quality of recovery, the patient's level of satisfaction measured using the QoR-15 index, a numerical parameter calculated by administering the Quality of Recovery 15 (QoR-15) questionnaire to the patient, 24 hours after surgery|Length of Hospital Stay, the duration of postoperative hospitalization, from the end of the surgical procedure to patient discharge
Efficacy And Safety Of Illumination Dose Reduction In Red Light Photodynamic Therapy For Actinic Keratoses
NCT Number: NCT06545396
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Actinic Keratoses
Interventions: OTHER: Half-dose illumination protocol|OTHER: Full-dose illumination protocol
Sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2025-03

Summary:
The goal of this clinical trial is to compare the tolerance and efficacy of conventional photodynamic therapy (PDT) with red light versus PDT with red light at half dose of illumination, as well as the changes produced by both interventions at the biomolecular level in patients with multiple actinic keratosis on the scalp. The main questions it aims to answer are:

Does PDT with half-dose illumination protocol maintain clinical and biomolecular efficacy?

Does PDT with half-dose illumination protocol improve intervention tolerance?

Researchers will compare both treatment protocols using the patient as its own control.

Participants scalp will be divided in two halves, one will be treated with PDT at conventional doses and the other with the half-dose illumination protocol, a skin biopsy will be obtained both pre and post-treatment of each of the areas. Variables will be assessed during the 3 visits of the study.

Primary Outcome Measures: Response of 75% of the treated actinic keratosis at 3 months post-intervention., Total count of actinic keratosis will be assessed, 3 months after de procedure
Secondary Outcome Measures: Tolerance during intervention, Pain assessed by Visual Analogue Scale (VAS), from 0 (no pain) to 10 (worst pain), During the procedure|Histological grade of actinic keratosis in biopsies as well as relevant biomarkers, E-cadherin, MMPs, p53, UEA, HSP47 and CD117/c-kit presence on the tissue (from + to +++, depending on the intensity), 3 months after the procedure
Nurse-led Education on Patients With Chronic Heart Failure and Their Informal Caregivers
NCT Number: NCT06545370
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Heart Failure
Interventions: OTHER: Intervention 1 / Nurse-led patients' education|OTHER: Intervention 2 / Nurse-led patients' & caregivers' education
Sponsor: Hellenic Mediterranean University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 280
Study Design: Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-09-01
Completion Date: 2027-09-01
Locations: Hellenic Mediterranean University, Heraklion, Crete, 71410, Greece

Summary:
The current study intends to examine the influence of nurse-led education on patients with chronic heart failure and their caregivers, with the goal of optimizing care for both and improving patients\&#39; clinical outcomes.

Primary Outcome Measures: Heart Failure Patients' Quality of Life, The heart failure patient's quality of life: To assess the quality of life of patients with heart failure, the Greek version of the Minnesota Living with Heart Failure Questionnaire (MLwHFQ) was used., from date of first communication with patient until the date of documented progression, assessed up estimate to 24 months.|Heart failure patients' self-care, The self-care behavior of heart failure patients: The Hippocratic Heart Failure Self-Care Scale is an 18-item scale created by Greek researchers (Brokalaki et al., 2024)., from date of first communication with patient until the date of documented progression, assessed up estimate to 24 months.|Medication adherence, The adherence of pharmacological treatment to heart failure patients: To assess adherence to medication in patients with cardiac deficiency, the Greek version of SEAMS will be used (Theofilou, 2023). SEAMS is a 13-item self-report medication adherence scale., from date of first communication with patient until the date of documented progression, assessed up estimate to 24 months.
Secondary Outcome Measures: Caregivers' quality of life, The quality of life of heart failure patients' caregivers: Assessing the quality of life of caregivers of heart failure patients will be done using the Greek version of the EuroQol EQ-5D tool (Kontodimopoulos et al., 2008)., From date of first communication with patient until the date of documented progression, assessed up estimate to 24 months.|Caregiving burden, The burden of the heart failure patients' caregivers: The assessment of the burden of caregivers of heart failure patients will be done through the Greek version of the HF Caregiver Questionnaire., From date of first communication with patient until the date of documented progression, assessed up estimate to 24 months.|Sense of guilt, The sense of guilt among heart failure patients' caregivers: Assessing the guilt of caregivers of heart failure patients will be done through the Greek version of the Caregiver Guilt Questionnaire (CGQ)., From date of first communication with patient until the date of documented progression, assessed up estimate to 24 months.
Effective Treatment of Shoulder Subluxation After Stroke With Modified Acupuncture of Biceps Brachii Muscle, Supraspinatus Muscle and Deltoid Muscle
NCT Number: NCT06545357
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Shoulder Subluxation After Stroke
Interventions: PROCEDURE: Acupuncture
Sponsor: University of Medicine and Pharmacy at Ho Chi Minh City
Collaborators: My-Suong Thi Phan|Dieu-Thuong Thi Trinh
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 72
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2023-07-28
Completion Date: 2024-06-18
Locations: Faculty of Traditional medicine - University of Medicine and Pharmacy of Ho Chi Minh City, Ho Chi Minh, Vietnam

Summary:
Stroke is the most common emergency in neurology and is also the leading cause of disability, so recovery of movement after stroke is very important. However, a common complication of stroke is shoulder subluxation, which hinders recovery of movement, thereby leading to shoulder pain and increasing the level of disability after stroke. Neuromuscular electrical stimulation affecting the biceps brachii muscle, supraspinatus muscle and deltoid muscles has been proven to be relatively effective in treating shoulder subluxation after stroke. However, this method does not go through the skin, so it is difficult to have a deep impact on the muscles and difficult to cause selective muscle contractions, so the treatment of this disease is still limited. In traditional medicine, modified acupuncture has a mechanism of action similar to neuromuscular electrical stimulation and is a method that passes through the skin, stimulating muscles effectively and selectively. In our study, we wanted to evaluate the effectiveness of treating shoulder subluxation after stroke with modified acupuncture of biceps brachii muscle, supraspinatus muscle and deltoid muscles

Primary Outcome Measures: The grade of shoulder subluxation was measured according to the qualitative method of Van Langenberghe and Hogan, After 4 weeks of intervention|The grade of shoulder subluxation was measured according to Hall J's quantitative method, After 4 weeks of intervention|Classification of treatment response according to shoulder subluxation grade (the qualitative method of Van Langenberghe and Hogan), After 4 weeks of intervention
Palliative Care Consultation to Improve Communication for Patients Considering Surgery for a Pancreatic Neoplasm
NCT Number: NCT06545344
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Pancreatic Neoplasm
Interventions: OTHER: Best Practice|PROCEDURE: Palliative Care Consultation|OTHER: Survey Administration|OTHER: Tumor Board Review
Sponsor: Fred Hutchinson Cancer Center
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-12-01
Completion Date: 2025-01-01
Locations: Fred Hutch/University of Washington Cancer Consortium, Seattle, Washington, 98109, United States

Summary:
This clinical trial evaluates a palliative care consultation for improving communication between providers and patients considering surgery for a pancreatic neoplasm. Pancreatic operations have known complications that can affect quality of life. Palliative care has been shown to improve patient reported quality of life and functional outcomes. Receiving a palliative care consultation may improve communication and decision making for patients considering surgery for a pancreatic neoplasm.

Primary Outcome Measures: Percentage of recruited patients that consent (acceptability), Acceptability will be defined as ≥ 60% of recruited patients consented., At time of consent|Percentage of patients randomized to the interventional arm who complete the palliative care consult prior to tumor board (feasibility), Feasibility will be defined as ≥ 60% of patients randomized to interventional arm who complete palliative care consult prior to pancreatic cancer specialty clinic tumor board., At time of multidisciplinary tumor board discussion (No more than 14 days after baseline)
Secondary Outcome Measures: Percentage of participants who complete the decisional conflict scale, At completion of 7 day follow-up timepoint|Percentage of participants who complete study measures within the first 90 days, At completion of 90 day follow-up timepoint|Percentage of participants randomized to usual care who go on to receive palliative care within the active study period, At 90 day follow-up timepoint
A Novel Sperm Selection Method Provides Advantages Over Conventional Approaches
NCT Number: NCT06545318
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Male Infertility
Interventions: DEVICE: Density Gradient Centrifugation|DEVICE: CA0 chamber
Sponsor: Center of Innovation Technology & Reproductive Medicine
Collaborators: Universidad Nacional Autonoma de Mexico
Sex: MALE
Age: ADULT
Enrollment: 115
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2023-01-01
Completion Date: 2023-11-15
Locations: CITMER, Mexico City, 11520, Mexico

Summary:
The goal of this clinical trial is to know if a novel sperm selection device (CA0) has a similar performance than the standard selection method in teratozoospermic and azoospermic men. The main questions it aims to answer are:

Does the CA0 sperm selection device increases the sperm concentration? Does the CA0 sperm selection device increases the sperm motility? What are the differences in sperm membrane potential when CA0 is used? Do intracellular Calcium levels change when CA0 is used? Does CA0 increase fertilization rates? Researchers will compare CA0 to the standard of care for sperm selection (density gradient centrifugation) to see if CA0 has similar performance

Participants will:

Provide a semen sample Have their semen sample analyzed, processed and used for assisted reproduction technologies

Primary Outcome Measures: Sperm membrane potential, Evaluation of the KCl-induced difference of membrane potential voltage in mV, after sperm selection., Within 2 hours from the sperm collection|Sperm intracellular Calcium, Evaluation of the progesterone-induced intracellular calcium fluorescent peaks after sperm selection, Within 2 hours from the sperm collection|Sperm concentration, Assessment of sperm count after sperm separation, Within 2 hours from the sperm collection|Sperm motility, Percentage of progresive, non-progressive and immotile sperm after sperm separation, Within 2 hours from the sperm collection|Fertilization rates, Determination of the rate of 2 pronucleous, 2 polar bodies zygotes after insemination, 17-20 hours after insemination by IVF or ICSI
Incidence and Risk Factors of Ocular Complications Among Patients With Homocystinuria
NCT Number: NCT06545305
Status: ENROLLING_BY_INVITATION
Study Type: OBSERVATIONAL
Conditions: Complications
Interventions: PROCEDURE: Lensectomy and vitrectomy
Sponsor: King Fahad Armed Forces Hospital
Sex: ALL
Age: ADULT
Enrollment: 6
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-01-01
Completion Date: 2024-08-30
Locations: King Fahad Armed Forces Hospital, Jeddah, 22522, Saudi Arabia

Summary:
Background: Cysteine beta-synthase (CBS) deficiency, often known as classic homocystinuria (HCU), is an uncommon inborn mistake in methionine metabolism. Developmental delay, intellectual incapacity, skeletal and vascular symptoms, and ocular abnormalities are possible main clinical characteristics.

Objective: This study sought to describe the ocular anomalies that King Fahad Armed Forces Hospital, Jeddah, Saudi Arabia, HCU patients presented with between 2018 and 2022.

Primary Outcome Measures: Autoref reading, Refractory errors, After one year
Microsampling for Therapeutic Drug Monitoring of Oral Oncolytics in Oncology Patients
NCT Number: NCT06545292
Acronym: MSTDM
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Drug Monitoring
Interventions: DIAGNOSTIC_TEST: Therapeutic drug monitoring with a dried blood spot and microatainer.
Sponsor: Leiden University Medical Center
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 360
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-09-01
Completion Date: 2027-07-01

Summary:
The aim of the study is to perform a clinical validation of the analytical method for dried blood spot microsampling of cabozantinib, pazopanib, sunitinib, Lenvatinib, nivolumab, ipilimumab, pembrolizumab, atezolizumab or bevacizumab. The secondary objective is to test the feasibility of home monitoring (microsampling TDM) of cabozantinib, pazopanib, sunitinib, Lenvatinib, nivolumab, ipilimumab, pembrolizumab, atezolizumab or bevacizumab in oncology patients.

Primary Outcome Measures: Method agreement between whole blood sample (WBS) and bry blood spot (DBS)., Blood concentrations of the oral oncolytic will be obtained 0 to 3 hours after ingestion of the oral oncolytic. Blood concentrations of immune checkpoint inhibitors will be obtained 0 hours after infusion and 15 minutes after end of the infusion. Passing-Bablok analysis will be performed to investigate a linear relationship between WBS and DBS. Bland-Altman analysis will be performed to evaluate method agreement. Method agreement between WBS and DBS was defined as ≥67% of the samples between the range of 0.80 and 1.20 (with or without correction factor following Passing-Bablok analysis), All samples will be collected within 3 months
The Success Rate and Acceptability of Conventional and Modified Hall Crowns Among Children and Parents
NCT Number: NCT06545279
Acronym: Hallcrowns
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Paediatric Dentistry|Dental Caries in Children|Dental Treatment
Interventions: PROCEDURE: Hall Crown Technique|PROCEDURE: Modified Hall Technique
Sponsor: King Abdullah University Hospital
Collaborators: Jordan University of Science and Technology
Sex: ALL
Age: CHILD
Enrollment: 121
Study Design: Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2023-08-04
Completion Date: 2025-04
Locations: Jordan University of Science and Technology, Irbid, Jordan

Summary:
This is a clinical trial that aims to compare the success rate, child and parent acceptance of conventional Hall crown technique (CHT) to modified Hall crown technique (MHT)in treating carious primary molars. Eligible children will receive CHT on one side and MHT on the other side. The time interval between both visits will be 1-2 weeks.Patients demographics and pain history will be recorded and pre-operative radiographs will be taken. An observer will assess and record the child's pain perception during each treatment visit. Time taken for each procedure will be recorded by the research assistant each visit prospectively from the moment the child sits on the dental chair till the end of procedure. Parental preference and child acceptance for each procedure will be recorded after treatment is finished using parent and child questionnaire. Clinical follow up will be conducted at 3,6 and 12 months to assess and compare the success rates of both techniques. Radiographs will be taken at 12 months to evaluate and compare radiographic success.

Primary Outcome Measures: Pain score, child's pain perception during intervention recorded by research assistant using sound,eyes and motor (SEM) scale, during intervention|Child discomfort score, Self-reported Child's discomfort after intervention using Wong-Baker FACES Pain Rating Scale, immediately following intervention|Child acceptance of treatment, Self-reported child acceptance using questionnaire, immediately following intervention|Parent acceptance of treatment, Parental acceptance using questionnaire, immediately following intervention|Rate of clinical success, Absence of pain symptoms/ dental abscess requiring pulp therapy or extraction ,assessed through taking pain history and clinical examination, 6,12 months|Rate of radiographic Success, Absence of radiographic pathology in the root and the bone in the inter-radicular area., 12 months
Secondary Outcome Measures: Time taken for intervention, Time taken for intervention, during intervention
Arthroscopic Debridement Followed by Intra-articular Injection of Micro-fragmented Adipose Tissue in Patients Affected by Knee Osteoarthritis
NCT Number: NCT06545266
Acronym: GemsforKnee
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Knee Osteoarthritis
Interventions: PROCEDURE: micro-fragmented adipose tissue injection
Sponsor: Istituto Clinico Humanitas
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 41
Study Design: Observational Model: |Time Perspective: p
Start Date: 2016-01
Completion Date: 2024-01

Summary:
Background/Objectives: Micro-fragmented adipose tissue is emerging as a promising option for the treatment of various diseases including knee osteoarthritis (OA), though clinical trials are often limited by small sample size and short follow-up periods. Our aim was to evaluate safety and clinical outcomes of an arthroscopic debridement followed by a single injection of micro- fragmented adipose tissue in patients affected by knee OA. Methods: From 2016 to 2020 patients affected by knee OA were enrolled. Micro-fragmented adipose tissue was obtained through the Lipogems kit and intraarticularly injected after an arthroscopic debridement. VAS for pain, Tegner score, Lysholm score, KOOS score subscales variations were assessed from baseline to 3-, 6-, 12-, 24- and 48 months follow-up.

Primary Outcome Measures: Visual Analogue Scale for pain (VAS), 3-, 6-,12-, 24- and 48 months follow-up.
Secondary Outcome Measures: Tegner score, 3-, 6-,12-, 24- and 48 months follow-up.|Knee Injury & Osteoarthritis Outcome (KOOS) score, 3-, 6-,12-, 24- and 48 months follow-up.|Failure rate, 3-, 6-,12-, 24- and 48 months follow-up.
A New Diagnostic Paradigm for Retinitis Pigmentosa Secondary to USH2A Pathogenic Variants
NCT Number: NCT06545253
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: USH2A Variant Retinitis Pigmentosa
Interventions: DIAGNOSTIC_TEST: microRNAs analysis
Sponsor: IRCCS Ospedale San Raffaele
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08
Completion Date: 2027-02

Summary:
Aim of the study is to perform a non-invasive multimodal retinal imaging investigation in a cohort of patients affected by USH2A retinitis pigmentosa (USH2A-RP), in order to develop a new diagnostic paradigm to categorize clinically relevant subgroups. All the procedures will be performed according to normal clinical practice. In addition, a novel quantitative profiling of serum microRNAs will be carried out in order to analyze the clinical importance of microRNA biomarkers in the clinical setting of the disease.

Primary Outcome Measures: Clinical relevance of microRNAs in USH2A-RP, For all patients enrolled, at baseline, peripheral blood sampling will be collected., 6 months period following the last follow-up visit
Secondary Outcome Measures: To test the association between specific microRNAs profiles and the quantitative multimodal retinal imaging findings, At baseline and month 12 follow-up visit, all enrolled patients with a genetically confirmed diagnosis of USH2A-RP, will undergo the following procedures:

* complete ophthalmic examination, including best corrected visual acuity measurement using standard ETDRS charts, intraocular pressure, slit-lamp biomicroscopy of the anterior and posterior segment;
* multimodal retinal imaging including: Ultrawide field imaging either with Optos devices; Blue-light fundus autofluorescence (FAF); Infrared imaging (IR); Multicolor imaging with Spectralis SD-OCT; Optical coherence tomography (OCT) with Spectralis SD-OCT; Optical coherence tomography angiography (OCTA) of the macula; visual field with standard 30.2 test pattern by Humphrey field analyzer., 6 months period following the last follow-up visit
Performance of Mid-Upper Arm Circumference for Detection of Severe Acute Malnutrition in Indonesian Under-Fives
NCT Number: NCT06545240
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Severe Acute Malnutrition
Interventions: DIAGNOSTIC_TEST: Mid-upper arm circumference
Sponsor: Indonesia University
Sex: ALL
Age: CHILD
Enrollment: 421
Study Design: Observational Model: |Time Perspective: p
Start Date: 2020-01-01
Completion Date: 2020-02-29
Locations: RSUPN Dr Cipto Mangunkusumo, Jakarta Pusat, DKI Jakarta, 10440, Indonesia|Puskesmas Cengkareng, Jakarta, DKI Jakarta, 11730, Indonesia

Summary:
WHO recommends 11.5 cm as a cut-off point of Mid-Upper Arm Circumference (MUAC) to detect and/or diagnose severe acute malnutrition (SAM) in under-five. MUAC is practical and useful, especially in area with limited facilities which has no standardized scale and infantometer. However, several studies showed that this cut-off need to be evaluated as it has modest detection rate for SAM. This study aims to evaluate diagnostic value of MUAC with 11.5 cm cut-off compared to WHZ as gold standard to identify SAM. The sensitivity, specificity, positive and negative predictive value of MUAC with 11.5 cm as a standard cut-off will be evaluated.

This study also aim to find new cut-off value that may offer better diagnostic performance. The main research questions were:

What is the diagnostic accuracy of Mid-Upper Arm Circumference (MUAC) compared to the Weight for Height Z Score (WHZ) in identifying SAM in children, and what is the optimal MUAC cut-off value for enhanced diagnostic performance?

Primary Outcome Measures: Diagnostic value of MUAC in diagnosing SAM compare to WHZ-index, To evaluate sensitivity, specificity, positive and negative predictive value of MUAC, 2 months
Secondary Outcome Measures: Finding new cut off value that offer better diagnostic performance using ROC, To compare sensitivity, specificity, positive and negative predictive value of MUAC with 11.5 cm as standard cut off and to new cut-off value that may offer better diagnostic performance, 2 months
RE001 T Cell Injection for the Treatment of KRAS G12V Mutated Solid Tumors
NCT Number: NCT06545201
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: KRAS G12V|T Cell Therapy
Interventions: BIOLOGICAL: RE001 T cell
Sponsor: Henan Cancer Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2027-04-01
Locations: Henan Cancer Hospital, Zhengzhou, Henan, 450008, China

Summary:
At present, there is an urgent need for new drugs for kirsten rat sarcoma viral oncogene (KRAS) mutant tumors in clinic. Preclinical studies support the specificity, safety and anti-tumor activity of RE001. Previous similar studies suggest the feasibility of T cell receptor engineered T cell therapy (TCR-T) treatment, and measures have been taken to ensure the safe administration of RE001 and the close monitoring and management of adverse events. To sum up, RE001 has controllable safety and anti-tumor activity on KRAS mutant solid tumor, which can be preliminarily studied to provide support for clinical research of patients with advanced solid tumor.

Primary Outcome Measures: Overall response rate (ORR)., Defined as the proportion of subjects with confirmed CR and PR., 24-36 months
Secondary Outcome Measures: Duration of response (DOR)., Defined as the time from cell infusion to disease progression or death in subjects achieving CR or PR., 24-36 months
Other Outcome Measures: Disease control rate (DCR)., Defined as the proportion of subjects who achieved CR, PR, and SD after treatment., 24-36 months|Stable disease (DOSD)., The definition refers to the period from the start of treatment to the time of evaluation for PD., 24-36 months|Progression-free survival (PFS)., Definition refers to the time from the subject's enrollment date (starting treatment date) to the occurrence of PD or death for any reason, whichever occurs first., 24-36 months|Overall survival (OS)., Definition refers to the time from the beginning of treatment to death from any cause., 24-36 months|Self-evaluation results of patients., EORTC QLQ-C30 scale was adopted and evaluated according to the scoring manual provided by EORTC., 24-36 months
Intracochlear Application of VSF1.01 for the Reduction of Cochlear Implant Surgery Related Trauma
NCT Number: NCT06545175
Acronym: ESCRT
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Hearing Loss
Interventions: DRUG: Intracochlear application of VSF1.01
Sponsor: Hannover Medical School
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 11
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2026-06

Summary:
The goal of this clinical trial is to assess the safety of intracochlear application of VSF1.01 for the reduction of cochlear implant surgery related trauma in patients with profound hearing loss with or without non-functional residual hearing in low frequencies and cochlear implantation.

The main questions it aims to answer are:

Primary objective:

Safety of intracochlear application of VSF1.01 in patients receiving cochlear implantation

Secondary objectives:

Effectiveness on

1. neural responses of auditory nerve
2. speech understanding
3. hearing thresholds
4. electrode impedances

During cochlear implant operation, patients receive as adjuvant treatment intracochlear VSF1.01 prior to insertion of the electrode array.

Cochlear implantation is conducted according to the clinical standard at the investigational site.

Primary Outcome Measures: Rate and severity of (serious) adverse events, Recording and documentation of number and severity of (serious) adverse events, Continuously from start to end of study [Start: IMP treatment (day 0), end of the study (Follow-up 5)], assessed up to approximately 6 months
Secondary Outcome Measures: Evaluation of eCAP growth function, Assessment of effectiveness on neural responses of auditory nerve by measuring electrically evoked compound action potential (eCAP; eCAP growth function), Continuously from start to end of study [Start: IMP treatment (day 0), end of the study (Follow-up 5)], assessed up to approximately 6 months|Evaluation of speech perception, Assessment of effectiveness on speech understanding by measuring speech perception (in quiet and in noise) by HSM 10dB SNR/5dB SNR, FBM, OLSA 50%, From Day 1 (FU 1) to end of study (FU 5), assessed up to approximately 6 months|Measurement of air and bone conduction, Assessment of effectiveness on hearing thresholds by measuring air and bone conduction from 125 Hz - 16,000 Hz by pure tone audiometry, At Screening/baseline and from Day 1 (FU 1) to end of study (FU 5), assessed up to approximately 6 months|Measurement of impedance levels, Assessment of effectiveness on electrode impedances by determination of impedance levels (as measure to rule out pathological levels and as part of clinical routine), From Day 0 to end of study (FU 5), assessed up to approximately 6 months
SUPPLEMENTATION WITH BETA GLUCAN AND ADAPTATIVE RESPONSE.
NCT Number: NCT06545149
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Clinical Course
Interventions: DIETARY_SUPPLEMENT: BioNutri AR-1,
Sponsor: Federal University of São Paulo
Collaborators: Kaiser Clinic and Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 44
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-10
Completion Date: 2025-12

Summary:
Abstract: Studies demonstrate that the use of nutritional supplements containing beta-glucans stimulates the immune system, modulates inflammatory activity, and promotes so-called immune training. Beta-glucans are prebiotics that stimulate the growth and activity of gastrointestinal microbiota and inhibit pathogen growth. Nutritional intervention is crucial for patients\&#39; positive evolution, and providing a supplement with highly bioavailable nutrients can make a difference in their nutritional, metabolic, and immune status. Therefore, the study aims to verify the effectiveness of the innate and adaptive immune response to a nutritionally balanced fermented food, containing oral or enteral beta-glucans, in patients treated at 3 Emergency Care Units in São José do Rio Preto, São Paulo, Brazil. This is a prospective randomized study with a characteristic design involving patients treated in the medical wards of 3 Emergency Care Unit. The following assessments will be conducted: Global Subjective Assessment for adults and Mini Nutritional Assessment for the elderly, Sociodemographic, and Laboratory Evaluation.

Primary Outcome Measures: length of hospital stay, during hospitalization
Secondary Outcome Measures: need for readmission, up to 24 weeks|need for ICU, up to 24 weeks