pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
The Importance of Insulin Action in the Brain for the Immune System During Physical Activity
NCT Number: NCT06552130
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Insulin Sensitivity
Interventions: OTHER: Spiroergometer test with intranasal insulin spray|OTHER: Spiroergometer test with intranasal placebo spray
Sponsor: University of Ulm
Sex: ALL
Age: ADULT
Enrollment: 20
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: SINGLE (PARTICIPANT)|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-08-15
Completion Date: 2026-09
Locations: Universityhospital Ulm, Ulm, 89081, Germany

Summary:
The goal of this clinical trial is to clarify the interaction of central insulin action and physical activity with the immune system.

Therefore, participants will undergo bicycle spiroergometer tests. This approach will be compared between days with insulin delivery to the brain as nasal spray and days with placebo spray.

Primary Outcome Measures: Immune system activation, Influence of central nervous insulin action on the activation of the immune system activation by exercise, measured by circulating cytokines and cytokines in the supernatant of stimulated peripheral blood mononuclear cells., 100 minutes|Immune system activation, Influence of central nervous insulin action on the activation of the immune system activation by exercise, measured by the composition of immune cells in circulation and cytokine release in the supernatant of stimulated peripheral blood mononuclear cells., 100 minutes
Secondary Outcome Measures: Maximal oxygen consumption (VO2max), Influence of central nervous insulin action on physical performance measured as VO2 peak during spiroergometry., 60 minutes|Heart rate variability, Influence of central nervous insulin action on the activity of the autonomic nervous system recorded by means of heart rate variability from an electrocardiogram., 100 minutes|Corticotropic pituitary axis modulation, Influence of central nervous insulin action in the activity of the corticotropin pituitary axis during physical activity, measured by cortisol, dehydroepiandrosterone and adrenocorticotropic hormone, 100 minutes|Leukocyte gene expression, Influence of central nervous insulin action on the gene expression of leukocytes during physical activity, 100 minutes|Individual anaerobic threshold, Influence of central nervous insulin action on physical performance. Individual anaerobic threshold assessed by lactate measurement from venous blood sampling., 60 minutes|Catecholamines, Influence of central nervous insulin action on the activity of the autonomic nervous system recorded by means of measuring catecholamine concentrations from venous blood., 100 minutes
Other Outcome Measures: sex differences, Potential differences in the above mentioned outcomes between sexes will be analyzed., 100 minutes
The Effects of Acupressure Applied to the Primiparous During Episiotomy
NCT Number: NCT06552104
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Episiotomy Wound|Pain|Anxiety
Interventions: BEHAVIORAL: ACUPRESSURE APPLI ACUPRESSURE APPLICATION
Sponsor: Esra SABANCI BARANSEL
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 126
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2023-06-01
Completion Date: 2023-12-30
Locations: Esra Sabancı baransel, Malatya, 44280, Turkey

Summary:
This study was conducted to determine the effects of acupressure applied during episiotomy repair on pain and anxiety levels of the primiparous.

The study was conducted as a randomized controlled trial with 126 pregnant women (63 women in the acupressure group and 63 women in the control) who applied to a maternity hospital between June and December 2023. Acupressure was applied to the acupressure group twice (during internal suturing and skin suturing) by the researcher during the episiotomy repair. Visual Analog Scale (VAS) was used a total of four times, before and after the intervention, to assess the pain scores of the participants, while the Spielberger Manual for State-Trait Anxiety Inventory (STAI) was used after the second intervention to determine the anxiety levels of the participants.

Primary Outcome Measures: VAS, The VAS was used to assess the pain severity of the incision site. The VAS is a scale created in the range of 0-100 mm. According to the scale, a score of 0 mm indicates that the pain is not severe at all, and a score of 100 mm indicates that the pain is extremely severe, Change inbreastfeeding self-efficacy levels at 6 weeks change in pain after acupressure
Secondary Outcome Measures: STAI, STAI was developed by Spielberger et al. (1970) to measure state and trait anxiety levels, and its adaptation, validity, and reliability study was conducted by Öner and Le Compte (1983) for the Turkish society. The STAI is a 20-item inventory, and a high score indicates that the individual has a high level of anxiety, while a low score indicates that the anxiety level is low. The lowest score that can be obtained from the scale is 20, and the highest score is 80. This scale, which is a 4-point Likert-type scale, is graded as Not at All, A Little, A Lot, and Extremely., Change inbreastfeeding self-efficacy levels at 6 weeks change in anxiety after acupressure
Activation of Biobank Registry for Bilio-pancreatic Diseases
NCT Number: NCT06552078
Acronym: BIO-PANCREAS
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Pancreatitis|Pancreatic Disease|Non-Neoplastic Pancreatic Disorder|Pancreatic Adenocarcinoma
Sponsor: IRCCS San Raffaele
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 2000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2021-06-09
Completion Date: 2030-12-31
Locations: IRCCS OSpedale San Raffaele, Milano, 20132, Italy

Summary:
The purpose of establishing the biobank is to create a collection of biological material and clinical data, with a prospective and retrospective mold, in order to investigate the role of genetic predisposition in multifactorial bilio-pancreatic diseases, so that an evaluation of the possible association in the pathogenesis of exogenous factors with endogenous factors can be allowed.

Multifactorial diseases are in fact an expression of genetic predisposition upon which one or more environmental stimuli act. Usually the aforementioned factors are not capable individually of triggering disease but, when simultaneously present, can cause the pathological phenotype. Therefore, it becomes important in the description of disease pathogenesis to identify as many risk factors for disease prevention and early diagnosis.

Primary Outcome Measures: The rate of patients with each pancreatic disorder presenting with certain exposures or certain biomarkers, The rate of patients with each pancreatic disorder presenting with certain exposures or certain biomarkers will be evaluated by descriptive statistics and when available compared with that of subjects without such disorders (controls)., Tthrough study completion, an average of 1 year
Evaluation of Cross-linked Collagen Membrane With and Without Silk Fibroin Around Immediate Dental Implants
NCT Number: NCT06552065
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Immediate Implant
Interventions: OTHER: collagen with silk fibroin membrane|OTHER: cross linked collagen membrane
Sponsor: Krishnadevaraya College of Dental Sciences & Hospital
Sex: ALL
Age: ADULT
Enrollment: 20
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2025-08
Locations: Krishnadevaraya college of dental sciences, Bangalore, Karnataka, 562157, India

Summary:
Comparative evaluation of cross-linked collagen membrane with and without silk fibroin around Immediate Dental Implants -Randomized controlled trial.

Primary Outcome Measures: To assess wound healing, gingival thickness and keratinized tissue width, Gingival tissue thickness assessment will be done at the site of implant placement 1.5 mm below the gingival margin of adjacent tooth. Local anaesthesia will be administered before the procedure and an Endodontic K-file with silicone disc stop will be used to measure. The depth will be measured with UNC-15 probe.

Apico-coronal width of keratinized tissue is measured as the distance from the mucogingival junction to the gingival margin, with the mucogingival junction determined using Schiller's Potassium Iodide Solution., pre implant placement , 6 weeks , 12 weeks
Secondary Outcome Measures: Radiovisiography with grid, assess increase in bone volume, pre implant placement , 6 weeks , 12 weeks
R-P NH of Genetic Vasculopathies
NCT Number: NCT06552052
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Multisystemic Smooth Muscle Dysfunction Syndrome
Sponsor: Massachusetts General Hospital
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-05-08
Completion Date: 2028-07
Locations: Massachusetts General Hospital, Boston, Massachusetts, 02114, United States

Summary:
This study will combine retrospective review of medical records from patients with ACTA2 and ongoing collection of clinical data using standardized instruments and intervals on an observational basis from patients with ACTA2.

Patients in cohorts 1-3 will be asked to attend clinic visits in person per the schedule of events. At minimum, the medical records of patients with ACTA2 will be reviewed to record data on aspects of the disease, including disease characteristics and developmental milestones. The study is planned to enroll a total of 100 patients: 7 in cohort 1, 7 in cohort 2, and the remaining in cohorts 3 and 4.

This study is planned to study patients for at least 3 years with the option to continue as long as possible for assessment of disease progression. During their continued study participation, as patients age, they may move into the next cohort. Beyond 3 years the duration of the study with be determined by availability of funding from sponsors.

Primary Outcome Measures: Retrospectively define sequence and timing of vascular and non-vascular symptoms and disease progression, 1.1 Develop patient surveys and identify retrospective/existing clinical data sources for aggregation, harmonization, and analyses of outcomes and biomarkers to be compared to existing published data. 1.2. Identify modifiers of symptom progression in patients with MSMDS. 1.3 Correlate the degree of disease progression by systems in 40 patients (cross-sectional study) and construct an MSMDS Rating Scale to evaluate disease severity and progression in children. 1.4 Create case report forms based on previously known and developed surveys in 1.1. to allow for standardized prospective data collection (Outcome 2)., 3 Years|Prospectively assess the rate of change of vascular and non-vascular disease in MSMDS using quantitative measures, patient/caregivers reported outcomes (PROs)., 2.1 Assess vascular and non-vascular disease progression over 3 years. 2.2 Compare the trajectory between clinical rating scales and patient-reported outcomes. 2.3 Correlate disease progression by individual and MSMDS-specific scale with other variables (age at diagnosis, sex, genetic variance, surgeries, etc)., 3 Years|Determine whether remote assessments with wearable technology systems are comparable with quantitative performance measures obtained in Aim 2, Use the Actigraphy wearable technology system in conjunction with a video consult to remotely assess gait, limb movement and exercise performance., 3 Years
Intermittent Theta Burst Stimulation on Anhedonia in Depression
NCT Number: NCT06552026
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Depression|Electroencephalography|Transcranial Magnetic Stimulation
Interventions: DEVICE: repeated transcranial magnetic stimulation
Sponsor: Anhui Medical University
Sex: ALL
Age: CHILD, ADULT
Enrollment: 33
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2020-08-12
Completion Date: 2022-12-14
Locations: Anhui Medical University, Hefei, Anhui, 230032, China

Summary:
Study comparing the efficacy of two TMS patterns (intermittent theta-burst stimulation, iTBS, and repetitive transcranial magnetic stimulation, rTMS) in treating anhedonia and their associated brain network mechanisms.

Primary Outcome Measures: Change in depression symptoms severity, The Hamilton depression rating scale-17 items (HAMD-17) to clinically assess severity of depression. The curative effects of the treatment were classified according to the reduction in HAMD. Response was defined as ≥50% symptom reduction from pre-to post-treatment with a HAMD score; remission criteria were set at a post-treatment score ≤7 for HAMD., Baseline;15 days after treatment|Change from baseline in Motivation and Pleasure Scale, Change from baseline in Motivation and Pleasure Scale The severity of participants' anhedonia assessed by the Motivation and Pleasure Scale change from baseline after the treatment., Baseline;15 days after treatment
Secondary Outcome Measures: The alteration from baseline in electrophysiological source imaging results in multimodalities, The activation of nucleus accumbens, dorsal lateral prefrontal cortex and the functional connection these brain area assessed by source-level resting-state EEG connectivity in multimodalities change from baseline after the treatment., Baseline;15 days after treatment
Action Towards Health Equity and Improved Air Quality in the Duwamish Valley: A Multilevel Asthma Intervention
NCT Number: NCT06552013
Acronym: DAISY
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Asthma in Children
Interventions: OTHER: MERV 13 filter|OTHER: Sham filter
Sponsor: University of Washington
Collaborators: National Institute of Environmental Health Sciences (NIEHS)
Sex: ALL
Age: CHILD
Enrollment: 80
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: PREVENTION
Start Date: 2024-07-30
Completion Date: 2028-07
Locations: Duwamish River Community Coaltion, Seattle, Washington, 98108, United States

Summary:
The goal of this randomized control trial is to learn if box fans and filters can reduce asthma symptoms and improve indoor air quality in children ages 6 - 17 years old with asthma living in the Duwamish Valley, Seattle, Washington. The main question it aims to answer are:

* Do box fans with filters improve asthma symptoms?
* Do box fans with filters improve an objective measure used to monitor lung function known as forced expiratory volume during the first second (FEV1)? Researchers will compare children living in households with high quality filters to those in households with sham filters to see if air quality and asthma symptoms improve.

Participants will

* fill out several questionnaires
* monitor their lung function with a peak flow meter
* place an air monitor in their homes to monitor indoor air quality
* run the box fan when they are at home

Primary Outcome Measures: Asthma symptoms, Symptoms are evaluated with the seven-item asthma control questionnaire (ACQ), a validated tool used in children., ACQ will be measured weekly for 6 consecutive weeks, two pre-intervention weeks (before box fans have been given to participant) and four weeks while fans are being used in the home. Symptoms will also be assessed at the six month follow-up visit.|FEV1, FEV1 is captured with a digital peak flow meter., FEV1 measures will be taken daily, once in the morning and once at night for the six week study time frame. Prior to the six month follow up we will ask participants to take three consecutive days of FEV1 measurements, for an additional 6 measures
Secondary Outcome Measures: Asthma quality of life, Will be assessed with the15-item mini-asthma quality of life questionnaire, a validated tool, Will be evaluated at baseline (visit 1), after 6 weeks (visit 3) and at 6 month follow up (visit 4)|Use of rescue medications, This is an item on the ACQ. See primary outcome., ACQ will be measured weekly for 6 consecutive weeks, two pre-intervention weeks (before box fans have been given to participant) and four weeks while fans are being used in the home. Symptoms will also be assessed at the six month follow-up visit.|Health care utilization in the past month, Will be assessed with the six-item asthma-related health care utilization questionnaire., Will be evaluated at baseline (visit 1), after 6 weeks (visit 3) and at 6 month follow up (visit 4)
Pre-operative Tumor Treating Fields in Patients With Resectable Lung Cancer
NCT Number: NCT06552000
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: NSCLC|Non Small Cell Lung Cancer
Interventions: DEVICE: NovoTTF-200T System
Sponsor: University of Texas Southwestern Medical Center
Collaborators: NovoCure Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 18
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-12-01
Completion Date: 2029-12-01
Locations: The University of Texas Southwestern Medical Center, Dallas, Texas, 75390, United States

Summary:
The purpose of this study is to study the clinical and biologic effects of Tumor Treatment Fields (TTFields) in patients undergoing resection of stage I-IIIA Non-Small Cell Lung Cancer (NSCLC). TTField is a non-invasive treatment that uses low-intensity electrical fields to treat cancer. Resection is the medical term for surgically removing part or all of a tissue, structure, or organ.

Primary Outcome Measures: Effect of TTF (Tumor-Treating Fields) on Fanconi anemia-related genes., Determine the effect of TTFields on expression of Fanconi anemia pathway-associated genes in NSCLC., approximately 14-28 days
Secondary Outcome Measures: Safety of administering TTFields, Assess the safety of administering TTFields prior to standard of care lung cancer resection.

Analyses will be performed for all subjects having initiated TTFields therapy. The study will use the CTCAE version 5.0 for reporting of adverse events., approximately 14-28 days
A Randomised Placebo Controlled Trial of Chronic Feeding of INuliN And Methylcellulose On Colonic fermentatioN
NCT Number: NCT06551961
Acronym: CINNAMON
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Irritable Bowel Syndrome
Interventions: DIETARY_SUPPLEMENT: methylcellulose|DIETARY_SUPPLEMENT: inulin|DIETARY_SUPPLEMENT: maltodextrin
Sponsor: University of Nottingham
Collaborators: Quadram Institute Bioscience
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 35
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-08-09
Completion Date: 2025-03-30
Locations: Nottingham Digestive Disease Centre, Nottingham, Nottinghamshire, NG7 2UH, United Kingdom

Summary:
To determine the effect on tolerance and gas production from chronic feeding of fermentable fibre (inulin) incorporated into a gel forming fibre (methylcellulose) compared with placebo (maltodextrin)

Primary Outcome Measures: Breath hydrogen 0-6 hours post ingestion, Area under curve (AUC) from time 0-6 hours (AUC 0-6) of breath hydrogen (ppm.hour) after consumption of inulin intake., 0-6 hours
Secondary Outcome Measures: Symptoms, 1) Self-reported symptom scores relating to gastrointestinal tolerance during 2-week chronic feeding period, 14 days|Breath hydrogen, 2) Area under curve (AUC) of breath hydrogen and methane for period 0 - 24hr., 0-24 hours|Orocaecal transit, Time for breath hydrogen to rise \> 10ppm over baseline, 0- 6 hours|Whole gut transit time, assessed by marker transit, 0-7 days|Fecal microbiota, 16s DNA analysis, 1 and 2 weeks post dosing
methylceIlulose or Psyllium on Fermentation of Inulin Assessed Using a Gas Sensing Capsule
NCT Number: NCT06551948
Acronym: REALISTIC
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Irritable Bowel Syndrome
Interventions: DIETARY_SUPPLEMENT: psyllium|DIETARY_SUPPLEMENT: methylcellulose|DIETARY_SUPPLEMENT: maltodextrin|DIETARY_SUPPLEMENT: inulin
Sponsor: University of Nottingham
Collaborators: Quadram Institute Bioscience
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-01-01
Completion Date: 2024-06-30
Locations: Nottingham Digestive Disease Centre, Nottingham, Nottinghamshire, NG7 2UH, United Kingdom

Summary:
We plan to measure the local (in vivo) production of hydrogen when methylcellulose is ingested, to see if we can show a shift of the site of fermentation to the distal colon.

We will achieve this using the Atmo pill, a recently developed ingestible gas-sensing wireless capsule manufactured by Atmo Biosciences. The pill is very similar in appearance and dimensions (26·8 mm long by 11·7 mm in diameter) to the Smart Pill, an FDA approved wireless capsule which measures local pH, which has been widely and safely used for over a decade. The Smart Pill is recommended for transit measurement by the American ACG Clinical Guidelines on Gastroparesis 3. The Atmo pill differs from the Smart Pill in measuring hydrogen and carbon dioxide within the colonic lumen rather than pH. The pill emits a radio signal to a small device worn by the participant to record the measurements periodically 4.

Primary Outcome Measures: Colonic hydrogen per quarter of colonic transit, mean hydrogen as % of colonic gas during the 4 quarters of colonic transit, up to 4 days
Secondary Outcome Measures: carbon dioxide gas production, carbon dioxide as % of colonic gas from colonic fermentation post-ingestion of fibre gel drink ll over each quartile of colonic transit (AUC Q1, Q2, Q3, Q4), up to 4 days
Other Outcome Measures: Breath hydrogen, Area under curve (AUC) from time 0-6 hours of breath hydrogen (ppm.hours), 0-6 hours|Regional transit times (hours) of Atmo pill;, up to 4 days
Effects of IASTM With and Without CT on Pain, ROM, and Functional Disability in Post-Operative Knee Stiffness Patients
NCT Number: NCT06551922
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Pain|Pain, Postoperative|Pain, Joint|Knee Pain Chronic
Interventions: COMBINATION_PRODUCT: Instrumental Soft Tissue Mobilization Technique with Conservative Treatment|COMBINATION_PRODUCT: Conservative Treatment
Sponsor: University of Lahore
Sex: ALL
Age: ADULT
Enrollment: 84
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-01-28
Completion Date: 2025-02
Locations: University of Lahore, Lahore, Punjab, 54590, Pakistan

Summary:
This single blinded randomized control study aims to determine the effects of instrumental soft tissue mobilization technique with and without conservative treatment in post operative knee stiffness patients. This study will recruit 84 participants fulfilling the inclusion criteria will be randomly divided into experimental and control groups using the lottery method. The assessor will be unaware of the treatment given to both groups. Data will be collected at baseline, at the end of the third week and at the end of 6th week. Baseline assessments will be conducted before the intervention. Post-intervention assessments will be conducted immediately after the intervention. This study aims to investigate the effectiveness of IASTM, both with and without traditional conservative treatment methods, in improving pain, range of motion, and functional ability in patients experiencing post-operative knee stiffness. By examining these factors, we can gain valuable insights into the potential of IASTM as a therapeutic intervention for this challenging condition.

Primary Outcome Measures: Pain Intensity, Pain level measured using a visual analog scale. It consists of a 10-centimeter line with endpoints labeled to represent the two extremes of the experience being measured. For pain, the typical endpoints are "no pain" on the left and "worst imaginable pain" on the right. For pain, a score of 0 means no pain, while a score of 10 represents the worst imaginable pain., 6 weeks (baseline, third week and then at the end of the sixth week)|Range of motion, Range of motion measured using a goniometer, 6 weeks (baseline, third week and then at the end of the sixth week)
Secondary Outcome Measures: Functional disability, Functional disability measured using the Lower Extremity Functional Scale. The scale consists of 20 items that assess the patient's ability to perform various activities, such as walking, running, and climbing stairs. The objective of the LEFS is to measure patients' initial function, ongoing progress, and outcome for a wide range of lower-extremity conditions. The maximum total score is 80, indicating no functional limitations.The minimum score is 0, indicating extreme limitations. The lower the total score, the greater the disability, 6 weeks (baseline, third week and then at the end of the sixth week)
Pemigatinib and Immune Checkpoint Inhibitor Treated FGFR1/2/3 Alteration Advanced Solid Tumor
NCT Number: NCT06551896
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Urothelial Carcinoma|Breast Neoplasms|Lung Cancer|Gastric Cancer|Soft Tissue Sarcoma|Other Carcinoma
Interventions: DRUG: Pemigatinib
Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-15
Completion Date: 2026-12-31

Summary:
This prospective phase Il study is aim to evaluate the efficacy and safety of FGFR inhibitor combined with immune checkpoint inhibitors in FGFR1/2/3 variant advanced solid tumors.

Primary Outcome Measures: Objective response rate (ORR), the proportion of patients with tumor shrinkage with CR and PR over 4 weeks., every 8 weeks during treatment
Secondary Outcome Measures: Disease control rate（DCR）, The proportion of patients with CR, PR and SD., every 8 weeks during during treatment|Progression-free survival （PFS）, PFS was defined as the time from random assignment to progression or death. Patients alive who had not experienced progression as of the analysis cutoff date were censored at the last disease assessment., every 8 weeks during treatment|Overall survival（OS）, OS was defined as the time from random assignment to death. For patients alive at the data cutoff date, OS was censored at the last follow-up date., every 8 weeks during treatment
Comparison of Split-dose and Single-dose Bowel Preparation Regimens Using Polyethylene Glycol Electrolyte(PEG)
NCT Number: NCT06551883
Acronym: PEG
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Bowel Preparation
Interventions: PROCEDURE: different bowel preparation regime|PROCEDURE: traditional bowel preparation regime
Sponsor: Tongji Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 101
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: OTHER
Start Date: 2021-01-01
Completion Date: 2021-06-20
Locations: Wang Xia, Wuhan, Hubei, 430000, China

Summary:
The goal of this quasi-experimental study was to compare the effect of single-dose and split-dose 3L compound polyethylene glycol electrolyte powder (PEG) regimen on the quality, comfort and tolerability of bowel preparation in patients who would undergo colonoscopy examination or treatment.

Participants in group A received a split-dose 3L PEG regimen, with 1L PEG taken on the night before the colonoscopy and 2L PEG taken 4-6 hours before the procedure. Participants in group B received a single-dose 3L PEG taken 4-6 hours before the colonoscopy.

Primary Outcome Measures: Bowel preparation quality, Bowel preparation quality was evaluated by the Boston Bowel Preparation Scale (BBPS), The BBPS scores were filled out by the treating physician in the designated area on the patient's examination request form and were collected and organized by the research team immediately after the end of the day's clinic|comfort, a self-designed comfort evaluation scale was used, with a linear visual analog rating scale ranging from 0 (comfortable) to 4 (extremely uncomfortable)., Patients self-evaluated their comfort level during the bowel preparation process after it was completed|tolerability, ①Patients self-assessed whether they were willing to undergo the same bowel preparation method again after the end of bowel preparation; ②Patients self-evaluated the difficulty of completing the bowel cleansing process after bowel preparation, with a score of very difficult (1 point), difficult (2 points), moderate (3 points), easy (4 points), and very easy (5 points), Patients finished the tolerability evaluation by themselves after completing bowel preparation and before being sent to the endoscopy center
Secondary Outcome Measures: sleep quality, Patients self-evaluated the quality of sleep on the night before bowel preparation, which is compared with usual and may be the same or slightly worse., Patients finished the sleep quality evaluation by themselves after completing bowel preparation and before being sent to the endoscopy center|adherence, Patients' compliance with medication was evaluated based on three indicators: whether the patient started taking the medication at the correct time, whether the medication was taken completely according to the instructions, and whether the patient engaged in active exercise after taking the medication, Patients finished the adherence evaluation by themselves after completing bowel preparation and before being sent to the endoscopy center
End-of-life Decision-making Among Young Patients With Advanced Cancer: a Grounded Theory Approach
NCT Number: NCT06551831
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: End-of-life Decision-making
Sponsor: National Taiwan University Hospital
Sex: ALL
Age: ADULT
Enrollment: 30
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-23
Completion Date: 2025-07
Locations: National Taiwan University Hospital, Taipei, 100, Taiwan

Summary:
The purpose of this qualitative research is to use grounded theory to explore and describe the thoughts of young advanced cancer patients regarding end-of-life care and how these thoughts influence the related decision-making process.

Primary Outcome Measures: Interview Guide, 1.The journey since diagnosis. 2. The most profound or recent medical decision. 3. The most profound or recent medical decision. 4. Anticipated future medical decisions. 5. Future end-of-life care options, 2024/7~2025/7
Clinical Research Protocol of Ferumoxytol for Magnetic Resonance Enhancement Imaging in Patients With Atherosclerosis.
NCT Number: NCT06551805
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Atherosclerosis
Interventions: DRUG: Safety assessment of Ferumoxytol.|DRUG: Assessment of the diagnostic value of Ferumoxytol for MR angiography.
Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-12
Completion Date: 2026-12-30
Locations: Department of Radiology, the Affiliated Drum Tower Hospital of Nanjing University, Nanjing, Jiangsu, 210008, China

Summary:
We are preparing to initiate a clinical trial involving Ferumoxytol for magnetic resonance-enhanced imaging in patients with atherosclerosis. The aim of this study is to assess the safety and effectiveness of Ferumoxytol for magnetic resonance angiography in patients with atherosclerosis.

Primary Outcome Measures: Ferumoxytol demonstrates a favorable safety profile in human subjects., safe, 2023.10-2026.12|Ferumoxytol exhibits diagnostic efficacy for MR angiography., diagnostic efficacy, 2023.10-2026.12
Other Outcome Measures: lower limb artery Image Acquisition, atherosclerosis, All patients underwent MRI after injection of polysaccharide superparamagnetic iron oxide injection.|Adverse Events, no adverse events, Before, during, after injection|Vital signs, safety, Obtained before injection, 15, 30, 45, 60 minutes after injection and before and after the second MR scan.
Effect of Serum Magnesium Level on the Success of Transforaminal Epidural Steroid Injection
NCT Number: NCT06551792
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Pain, Back
Interventions: OTHER: Effect of Serum Magnesium Level on the Success of Transforaminal Epidural Steroid Injection
Sponsor: Kanuni Sultan Suleyman Training and Research Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 300
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-01
Completion Date: 2024-09-15
Locations: Kanuni Sultan Süleyman Training and Research Hospital, Istanbul, 34000, Turkey

Summary:
Transforaminal epidural steroid injection (TFESE) is an interventional method frequently used in the treatment of radicular pain due to disc herniation. TFESE, which is applied under sterile conditions and under fluoroscopy guidance, increases its effectiveness when applied in the early period (first 3 months). Inflammation and increase in neurotransmitters in the nerve root due to disc herniation trigger pain. Steroids and local anesthetics applied to the nerve root with TFESE exhibit strong anti-inflammatory effects. Factors affecting the success of TFESE include the type and dose of drugs, the age of the patient, any accompanying comorbidities, the level of injection administered and other musculoskeletal problems. Studies on the effect of these parameters on the effectiveness of TFESE are limited.Cardiac arrhythmia, muscle spasms, tetany, fasciculation paresthesia, widespread body pain, impaired bone mineralization, electrolyte disorders such as hypokalemia, hypocalcemia, hypophosphatemia, depression, and seizures may occur due to magnesium deficiency. One of the most important causes of low back pain is degenerative disc disease, and magnesium deficiency has been shown to be associated with low back pain.

Primary Outcome Measures: In this study, serum magnesium levels before the procedure are effective in the success of, In this study, serum magnesium levels before the procedure are effective in the success of the TFESE procedure in patients with low back pain due to lumbosacral disc herniation., There is a correlation between intracellular magnesium deficiency and serum magnesium levels
The Application of Photosensitive Hydrogel in Intranasal Endoscopic Dacryocystorhinostomy
NCT Number: NCT06551766
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Chronic Dacryocystitis
Interventions: DEVICE: Photosensitive hydrogel|DEVICE: 6-0 absorbable stitches
Sponsor: Eye & ENT Hospital of Fudan University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-03-01
Completion Date: 2024-12-31
Locations: Eye & ENT Hospital of Fudan University, Shanghai, 200031, China

Summary:
To study the effect of Photosensitive hydrogel used for suture free anastomosis of lacrimal cyst and nasal mucoperiosteal flap in endoscopic nasal dacryocystostomy, and evaluate its adhesion to lacrimal cyst and nasal mucoperiosteal flap, promoting wound healing, forming a good anastomosis, preventing postoperative anastomosis and shortening operation time. Twenty patients with chronic dacryocystitis were randomly divided into photosensitive hydrogel group and suture group.Symptoms and nasal endoscopy were followed up 2, 6, and 12 weeks after surgery for both groups. And also adverse events were recorded at each follow-up.

Primary Outcome Measures: Anastomotic opening rate, The opening of the anastomosis was observed by nasal endoscopy., 6 weeks after surgery
Secondary Outcome Measures: Remission rate of tearing symptoms, The remission of tearing symptoms was assessed by VAS scale, 2, 6 and 12 weeks after surgery
Phase 1 Study in Diabetes Mellitus(Fed)
NCT Number: NCT06551740
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Diabetes|Diabete Mellitus
Interventions: DRUG: HUC2-344|DRUG: HUC2-344-R1, HUC2-344-R2
Sponsor: Huons Co., Ltd.
Sex: MALE
Age: ADULT, OLDER_ADULT
Enrollment: 34
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-04-15
Completion Date: 2024-06-10
Locations: Huons, Seongnam-si, Gyeonggi-do, 13486, Korea, Republic of

Summary:
An open-label, randomized, Fed, single-dose, 2-sequence, 2-period, crossover phase 1 study in healthy volunteers.

Primary Outcome Measures: Cmax, Maximum concentration of HUC2-344, 0,1,2,3,4, 4.5,5.5,6,7,8,9,10,12,24,48hours|Tmax, Time of concentration, 0,1,2,3,4, 4.5,5.5,6,7,8,9,10,12,24,48hours|AUCt, Area under the drug concentration-time curve, 0,1,2,3,4, 4.5,5.5,6,7,8,9,10,12,24,48hours
The Effect of Neurophysiological Facilitation Techniques on Health Parameters in Early Stages After Open Heart Surgery
NCT Number: NCT06551714
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Open Heart Surgery|Cardiovascular Disease|Physiotherapy
Interventions: PROCEDURE: Phase 1 cardiac rehabilitation|PROCEDURE: Neurophysiological facilitation techniques
Sponsor: Dogus Universitesi
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 32
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-01-01
Completion Date: 2024-11-01
Locations: Lokman Hekim Akay Hospital, Ankara, 06000, Turkey

Summary:
In this study, researchers aimed to investigate effects of neurophysiological facilitation on functional capacity and respiratory parameters of patients who underwent open heart surgery.

Do neurophysiological facilitation techniques improve individuals' respiratory parameters more than phase 1 cardiac rehabilitation?

Do neurophysiological facilitation techniques improve individuals' functional capacity more than phase 1 cardiac rehabilitation?

Researchers will apply phase 1 cardiac rehabilitation to both groups to see the effectiveness of neurophysiological facilitation techniques.

Primary Outcome Measures: İnspiratory muscle strength, Maximum Inspiratory Pressure (MIP) - pressure, Before and after treatment on each day of treatment, up to 3 month|Expiratory muscle strength, Maximum Expiratory Pressure (MEP) - pressure, After and before treatment on each day of treatment, up to 3 month|2 Minute Walk Test, It is walking as fast as the person can for 2 minutes without any assistance, at a safe distance of 30 meters. - meter, Before treatment on the first day of treatment and after treatment on the last day of treatment, up to 3 month|Time Up and Go (TUG), The person gets up from the chair, walks 3 meters, comes back and sits on the chair. - minute, first day of treatment before treatment and last day of treatment after treatment, up to 3 month|Vital sign, Oxygen saturation, Before and after treatment on each day of treatment, up to 3 month|Respiratory frequency, Number of times a person inhales and exhales in 1 minute. - number, Before and after treatment on each day, up to 3 month|Blood pressure, Blood pressure is the pressure of blood within the arteries of the circulatory system. - pressure, Before and after treatment on day of treatment, up to 3 month|Heart rate, Number of times a person heart rate in 1 minute. - number, Before and after treatment on each day of treatment, up to 3 month|Life quality, The Minnesota Living with Heart Failure Questionnaire, Before treatment on the first day of treatment and after treatment on the last day of treatment, up to 3 month|Depression, Beck's depression inventory, Before treatment on the first day of treatment and after treatment on last day of treatment, up to 3 month|Symptom, Dyspnea, Before and after treatment on each day of treatment, up to 3 month
ACHIEVE Pilot Statins for Vascular Protection
NCT Number: NCT06551701
Acronym: ACHIEVE
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: ASCVD
Interventions: OTHER: Pharmacist call
Sponsor: Duke University
Collaborators: Carelon Research|Harvard Pilgrim Health Care|National Heart, Lung, and Blood Institute (NHLBI)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 225
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-31
Completion Date: 2025-05-31
Locations: Duke Clinical Research Institute, Durham, North Carolina, 27701, United States

Summary:
ACHIEVE aims to increase statin usage among patients with ASCVD by having a pharmacist talk to patients and providers.

Primary Outcome Measures: Provider engagement as measured by recruitment, The goal is recruiting at least 25% of identified providers., 2 years|Patient engagement as measured by recruitment, The goal is to recruit at least 30% of identified patients overall and within the black population, 2 years
Effect of Silkworm Pupa Tablets in Gastrointestinal Malignancies at Nutritional Risk Following Radical Surgery
NCT Number: NCT06551675
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Nutritional Deficiency|Gastrointestinal Cancer|Frailty Syndrome
Interventions: DIETARY_SUPPLEMENT: Silkworm pupa tablets|DIETARY_SUPPLEMENT: Control product
Sponsor: Xiaosun Liu, MD
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 120
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-14
Completion Date: 2025-11
Locations: Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University, Hangzhou, Zhejiang, 310000, China|he First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, Zhejiang, 310003, China|The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, Zhejiang, 310003, China|The Second Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, Zhejiang, 310009, China

Summary:
This is a randomized, double-blind, very low dose parallel-controlled, prospective, multi-center trial evaluating the improvement of nutritional status and frailty with silkworm pupa tablets after radical resection of gastrointestinal malignancies for 3 months intervention. The primary endpoints are body weight and frailty prevalence, The secondary endpoints are body mass index (BMI), skeletal muscle index (SMI) at the third lumbar vertebra (L3-SMI), sarcopenia prevalence and quality of life.

Primary Outcome Measures: Body weight, Measured at baseline and 1 month, 2 months, 3 months after enrollment, 3 months|Frailty prevalence, The incidence of frailty, using Fried frailty phenotype to assess physical frailty, measured at baseline and 1 month, 2 months, 3 months after enrollment, 3 months
Secondary Outcome Measures: Body mass index (BMI), Calculated as weight (kg)/height (m2), measured at baseline and 1 month, 2 months, 3 months after enrollment, 3 months|L3-SMI, Derived as the ratio of skeletal muscle area (SMA) to height \[SMA (cm2)/height (m2)\], at the third lumbar vertebra, measured at baseline and after 3 months, 3 months|Sarcopenia prevalence, The incidence of sarcopenia, using the diagnostic criteria for sarcopenia published by the Asian Sarcopenia Working Group (AWGS) in 2019 or L3-SMI criteria, measured at baseline and 1 month, 2 months, 3 months after enrollment, 3 months|Quality of life, Using the questionnaire of EORTC QLQ-C30 measured at baseline and 1 month, 2 months, 3 months after enrollment, 3 months|Quality of life, Using the questionnaire of EORTC QLQ-STO22, measured at baseline and 1 month, 2 months, 3 months after enrollment, 3 months
CAN3T - Canadian TAVI Triage Tool
NCT Number: NCT06551610
Acronym: CAN3T
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Trans-catheter Aortic Valve Implantation|TAVI|Aortic Stenosis|Surgical Aortic Valve Replacement
Interventions: OTHER: Triage Tool
Sponsor: Sunnybrook Health Sciences Centre
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 5060
Study Design: Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2024-10
Completion Date: 2027-08

Summary:
The goal of this trial is to see if a tool that may reduce wait times will reduce bad outcomes in participants on the TAVI waitlist. The main questions it aims to answer are:

* How many deaths, hospitalizations, or urgent TAVI procedures take place while participants wait
* Days alive and out of hospital at 30 days and 12 weeks, total health care costs, and wait times

Researchers will compare usual wait times to see if the tool reduces death, hospitalizations, and urgent procedures.

Primary Outcome Measures: To assess the efficacy of using the CAN3T tool in triage compared to standard care, in TAVI patients, including: reduce wait-time adverse events, improve patient-centred outcomes, and reduce wait-time health care utilization., Composite of death, all-cause hospitalization or urgent TAVI (in-hospital and unplanned TAVI) on the TAVI waitlist. The waitlist period is defined as period between TAVI referral and first of either death, TAVI procedure or off list., From the beginning of enrollment and continuing for 32 months.
Phase I Trial for Patients w/ Advanced Hematologic Malignancies Undergoing Allogeneic HCT
NCT Number: NCT06551584
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Acute Myeloid Leukemia|Acute Lymphoid Leukemia|Mixed Phenotype Acute Leukemia|Myelodysplastic Syndromes
Interventions: DRUG: ORCA-T
Sponsor: Lori Muffly
Collaborators: Orca Biosystems, Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 24
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-10
Completion Date: 2026-12
Locations: Stanford University, Palo Alto, California, 94304, United States

Summary:
The study goal is to characterize the safety of the combination of Orca-T with dual agent GVHD prophylaxis.

Primary Outcome Measures: Proportion of Patients Without Severe Transplant-Related Adverse Events at Day +100, The proportion of patients who, at Day +100 have not experienced any severe transplant-related adverse events including non-relapse mortality (NRM), primary graft failure, acute GVHD (grade 2-4), acute GVHD grade 3-4, or opportunistic infections (grade 4-5)., 18 months