pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
The Effects of Topical Almond Oil and Tretinoin on Facial Wrinkles
NCT Number: NCT06571721
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Collagen Degeneration|Wrinkle|Pigmentation|Elastic Skin|Sebum Deficiency
Interventions: OTHER: Topical Product: Almond Oil|OTHER: Topical Product: Almond oil augmented with 0.5% Vitamin E|OTHER: Topical Product: 0.025% Tretinoin oil augmented with castor oil
Sponsor: Integrative Skin Science and Research
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 90
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-22
Completion Date: 2025-07-22
Locations: Integrative Research Institute, Sacramento, California, 95819, United States

Summary:
Investigate the topical use of almond oil, almond oil augmented with 0.5% vitamin E, 0.025% tretinoin oil augmented with castor oil on the appearance of facial fine lines and wrinkles, pigmentation, hydration, trans-epidermal water loss, and sebum excretion rate.

Primary Outcome Measures: Facial wrinkles, Change in severity of wrinkles measured by photographic analysis (BTBP 3D Camera System), 16 Weeks
Secondary Outcome Measures: Changes in Pigment intensity through the use of high resolution photography (BTBP Clarity Pro), Change in the appearance of facial pigmentation by high resolution photography (BTBP Clarity Pro) and measures intensity of facial pigmentation. Higher scores indicate darker pigmentation., 16 Weeks|Pigment intensity measured through SkinColorCatch., Change in the appearance of facial pigmentation will be measured on both cheeks through the use of a handheld device known as the SkinColorCatch with quantitative output for pigment intensity., 16 Weeks|Changes in skin hydration, Change in skin hydration will be measured on both cheeks through the use of a non-invasive device known as the Moisturemeter., 16 Weeks|Sebum excretion rate, Measure of skin sebum via sebumeter, 16 Weeks|Tolerability Assessment Questionnaire, A 6 question survey based on the self-assessment about the tolerability of the topical skin product. The scale ranges from 0-3 with 0 being the best outcome possible and with 3 being the worst. "0" as none, "1" as mild, "2" as moderate, or "3" as severe., 16 Weeks|Transepidermal water loss, Change in transepidermal water loss (TEWL) using the Vapometer, 16 Weeks
A Study of Gemcitabine/Cisplatin Plus Cemiplimab (REGN2810, Anti-PD-1) With or Without Fianlimab (REGN3767, Anti-LAG-3) in Patients With Localized Muscle-invasive Bladder Cancer (NeoSTOP-IT)
NCT Number: NCT06571708
Acronym: NeoSTOP-IT
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Bladder Cancer|Muscle-Invasive Bladder Carcinoma
Interventions: DRUG: Gemcitabine|DRUG: Cisplatin|DRUG: Cemiplimab|DRUG: Fianlimab
Sponsor: Columbia University
Collaborators: Regeneron Pharmaceuticals
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 36
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-11
Completion Date: 2028-12
Locations: Columbia University Irving Medical Center, New York, New York, 10032, United States

Summary:
The goal of this clinical trial is to learn if gemcitabine/cisplatin plus cemiplimab with or without fianlimab works to treat bladder cancer in adults. The main question it aims to answer is: Can gemcitabine, cisplatin, and cemiplimab with or without fianlimab treat bladder cancer?

Participants will be randomly selected (like the loss of a coin) to treatment with gemcitabine, cisplatin, cemiplimab, and fianlimab or gemcitabine, cisplatin, and cemiplimab.

Participants will:

* Undergo transurethral resection of bladder tumor (TURBT) followed by the start of treatment, receive 4 cycles of treatment (21 day cycles)
* After 4 cycles of treatment, patients will undergo repeat maximal TURBT with imaging
* Participants with a complete response will continue maintenance cemiplimab or cemiplimab/fianlimab for 13 more cycles with imaging every 3 months
* Participants without a complete clinical response will undergo cystectomy (bladder surgery).

Primary Outcome Measures: Clinical Complete Response, Rate of clinical complete response after 4 cycles of neoadjuvant chemoimmunotherapy. Complete clinical response will be defined as:

* No high-grade malignancy on repeat TURBT
* No malignant cells on urine cytology
* No definitive evidence of invasive local or metastatic disease on cross-sectional imaging (CT chest, abdomen, and pelvis with contrast or, if renal dysfunction, MRI with contrast)

Cytoscopy and imaging should occur within 4 weeks of end of neoadjuvant therapy., 16 weeks
Secondary Outcome Measures: Number of Adverse Events, Defined as the occurrence of any adverse event (AE) related to the investigational drugs at any point on treatment until 30 days after the last dose of treatment. AEs as evaluated per Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, 30 days after last dose of treatment, up to 56 weeks|Bladder-intact survival, Bladder-intact survival is defined as the time from start of treatment until cystectomy or death., Up to 5 years|Recurrence-free survival, Recurrence-free survival is defined as the time from start of treatment until disease recurrence or death. Recurrence-survival will only be measured in patients who achieve a clinical complete response., Up to 5 years|Overall survival, Overall survival is defined as the time from start of treatment until death., Up to 5 years
Comparison of Target Controlled Infusion Anesthesia and Inhalation Anesthesia in Pediatric Laparoscopic Surgeries
NCT Number: NCT06571682
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Laparoscopic Surgery|Target Controlled Infusion
Interventions: DEVICE: Target Controlled Infusion|DRUG: Inhalation anesthetic
Sponsor: TC Erciyes University
Sex: ALL
Age: CHILD
Enrollment: 60
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-15
Completion Date: 2025-03-30

Summary:
Comparison of Target Controlled Infusion Anesthesia and Inhalation Anesthesia in Pediatric Laparoscopic Surgeries

Primary Outcome Measures: Modified Aldrete Scoring System, The effects on recovery were monitored within the first hour of the postoperative period using the Modified Aldrete Scoring System (MASS). Totally 0-10 points can be given by MASS. Higher scores predicts better recovery., Aftet surgery 1 hour
Secondary Outcome Measures: Blood pressure (mmHg), The blood pressure of the patients will be measured and recorded in mmHg at five-minute intervals from the beginning until the first postoperative hour., After surger 1 hour|Heart rate (beats/minute), The heart rate of the patients will be measured and recorded in mmHg at five-minute intervals from the beginning until the first postoperative hour., After surgey 1 hour
BOOM-IBD2 to Evaluate the Sacral Neuromodulation in IBD Patients
NCT Number: NCT06571669
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Ulcerative Colitis|Inflammatory Bowel Diseases
Interventions: DEVICE: Neuromodulation
Sponsor: Boomerang Medical
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 137
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-10-01
Completion Date: 2026-09-01

Summary:
The BOOM-IBD2 clinical trial is designed to evaluate the effectives of sacral neuromodulation for the treatment of ulcerative colitis.

Primary Outcome Measures: Decrease in Urgency Numeric Scale (NRS), Primary endpoint is achieving decrease at 12 weeks, 12 weeks
Secondary Outcome Measures: Total IBDQ Score, 12 and 52 weeks|Mayo endoscopic score, 12 and 52 weeks|Increase in IBDQ score, 12 and 52 weeks|Rate of device-related SAEs, 4 and 52 weeks
Evaluation of the Safety and Tolerability of Ocular Lubricants
NCT Number: NCT06571656
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Dry Eye Disease
Interventions: OTHER: FID123359 test formulation|OTHER: FID123360 test formulation|OTHER: FID123361 test formulation|OTHER: FID121843 ocular lubricant
Sponsor: Alcon Research
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-12
Completion Date: 2025-05
Locations: School of Optometry and Vision, Sydney, New South Wales, 2052, Australia|The University of Melbourne, Department of Optometry and Vision Science, Carlton, Victoria, 3053, Australia|Deakin Collaborative Eye Care Clinic, Waurn Ponds, Victoria, 3216, Australia

Summary:
The purpose of this study is to evaluate the safety and tolerability of three new artificial tear formulations in subjects with moderate dry eye disease.

Primary Outcome Measures: Number of Treatment-Emergent Adverse Events (AEs), An AE is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users, or other persons, whether or not related to the investigational medical device (test product). The number of adverse events as observed or reported will be recorded., Visit 2 (2 to 45 days after the Screening Visit) through Visit 6/Study Exit. Visit 6 will occur 7 to 27 days after Visit 2 depending on observed visit windows.|Number of Subjects with Biomicroscopy Findings Outside of Normal Limit, The investigator will observe the corneal and other ocular structures under white light of the slit lamp. The number of subjects with biomicroscopy findings outside of normal limits will be recorded., Screening Visit through Visit 6/Study Exit. Visit 6 will occur 9 to 77 days after Screening Visit, based on observed visit windows.|Best Corrected Visual Acuity (BCVA) with Manifest Refraction (MR), BCVA with MR will be assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) letter charts and recorded in logarithm Minimum angle of resolution (logMar)., Screening through Visit 6/Study Exit. Visit 6 will occur 9 to 77 days after Screening Visit, based on observed visit windows.
PMMHRI - Familial Hypercholesterolemia Registry
NCT Number: NCT06571630
Acronym: FH-Registry
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Familial Hypercholesterolemia
Sponsor: Polish Mother Memorial Hospital Research Institute
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 300
Study Design: Observational Model: |Time Perspective: p
Start Date: 2018-01-01
Completion Date: 2025-12-31
Locations: Polish Mother Memorial Research Institute (PMMHRI) in Lodz, Poland, Lodz, 93-338, Poland

Summary:
The registry is maintained at the Regional Centre for Rare Diseases, established in 2016, within Polish Mother's Memorial Hospital Research Institute. This facility diagnoses and treats over 80 distinct rare diseases in patients from across the country, including those with phenotypically or genetically confirmed familial hypercholesterolemia (FH).

Primary Outcome Measures: Therapeutic goals achivement, For each patient, we collect data on the levels of all lipid profile fractions: such as total cholesterol \[mg/dl\], low density lipoprotein cholesterol - LDL \[mg/dl\], high density lipoprotein cholesterol HDL \[mg/dl\], triglycerides \[mg/dl\], non-HDL \[mg/dl\] and lipoprotein(a) during both dual and triple therapy. Additionally, we will assess the achievement of the therapeutic target as defined by the ESC guidelines. The therapeutic target for each patient will be evaluated individually based on their risk, in accordance with the ESC guidelines., 5 years
F-URS and Mini PCNL for Pediatric Urolithiasis
NCT Number: NCT06571617
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Urolithiasis
Interventions: PROCEDURE: Mini PCNL (mini percutaneous nephrolithotomy)|PROCEDURE: RIRS (retrograde intrarenal surgery/ flexible URS)
Sponsor: Mansoura University
Sex: ALL
Age: CHILD
Enrollment: 160
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, CARE_PROVIDER)|Primary Purpose: TREATMENT
Start Date: 2024-09-10
Completion Date: 2025-04-05
Locations: Urology and nephrology center, Mansourah, Dakahlia, 35516, Egypt

Summary:
To compare RIRS versus mini-perc PNL in the management of medium size pediatric renal stones (10-20 mm) through a RCT.

Primary Outcome Measures: the primary outcome, the stone-free rate, no evidence of any residual fragment by NCCT or KUB or clinical insignificant residual fragments (CIRF) ≤ 4 mm in maximum diameter in a single session within the first month postoperatively., at 4 weeks postoperatively
Secondary Outcome Measures: The Secondary outcomes, perioperative parameters, intraoperative complications, operation time in minutes, fluoroscopy time in seconds, lasing time in seconds, laser energy in joles, hemoglobin deficit, postoperative complications, hospital stay in days, intraoperative and first day postoperatively
Other Outcome Measures: the tertiary outcome. post operative pain score, assessment of pain at postoperative day 1 (PODI), For children \< 7.5 years, we will use the validated Arabic version of Wong-Baker FACES scale (WBF). For older children, we will use the validated Arabic version of visual analogue scale (VAS), at first day post operative
Preoperative Gluteal Muscle Atrophy: A Silent Predictor of THA Dislocation.
NCT Number: NCT06571604
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Dislocation|Total Hip Arthroplasty|Muscle Degeneration
Interventions: DIAGNOSTIC_TEST: Dislocation|DIAGNOSTIC_TEST: No dislocation
Sponsor: Centre Hospitalier Universitaire de Nīmes
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 72
Study Design: Observational Model: |Time Perspective: p
Start Date: 2020-01-01
Completion Date: 2023-05-01
Locations: CHU Nîmes, Nîmes, Gard, 30900, France

Summary:
This study looks at how fat buildup in hip muscles relates to hip osteoarthritis and less favorable recovery after hip replacement surgery. While it is known that weak gluteal muscles might cause problems, it is not yet proven if this specifically leads to hip dislocation after surgery. The goal of this study is to compare fat buildup in gluteal muscles between patients who had a hip dislocation soon after surgery and those who did not.

Primary Outcome Measures: Mean Attenuation Ratio, The mean attenuation ratio (MAR), representing muscle fat degeneration, corresponds to the mean grayscale pixels in the selected area, expressed in Hounsfield Units (HU). Subsequently, the segmentation process was applied, selectively retaining pixels within the range of -30 HU to 150 HU. This range corresponds to muscle fibers and intramuscular fat, effectively excluding extra-fascial fat and bone pixels., The CT scan of the pelvis used to plan the operation is performed between one and two months before the surgery.
Secondary Outcome Measures: Cross-Sectional Area, The cross-sectional area (CSA), measured in square centimeters (cm²) defines the average muscle surface area., The CT scan of the pelvis used to plan the operation is performed between one and two months before the surgery.|Intramuscular Fatty Fraction, Finally, the intramuscular fatty fraction (IFF) or percentage of intramuscular fat was calculated using the IB Delta Suite plug-in with thresholds of -30/0/150. Pixels below -30 HU and above 150 HU were designated as extra-muscular, while pixels ranging between 0 HU and 150 HU represented muscle fibers. Pixels falling between -30 HU and 0 HU denoted intramuscular fat, constituting the IFF., The CT scan of the pelvis used to plan the operation is performed between one and two months before the surgery.
Efficacy and Safety of Pioglitazone Combination Therapy in Type 2 Diabetes Patients on a Background of Empagliflozin With Metformin
NCT Number: NCT06571591
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: T2DM
Interventions: DRUG: CT-L03-301 Group 1|DRUG: CT-L03-301 Group 2|DRUG: Placebo|DRUG: Empagliflozin|DRUG: Metformin
Sponsor: Celltrion
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 582
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2026-05
Locations: Celltrion, Incheon, Korea, Republic of

Summary:
Phase 3 study to assess the Efficacy and Safety of CT-L03-301 in Type 2 Diabetes Patients with Insufficient Glycemic Control with Metformin and Empagliflozin Combination Therapy.

Primary Outcome Measures: HbA1c, Change from Baseline in HbA1c, Week 24 of the Treatment
Secondary Outcome Measures: HbA1c, Change from Baseline in HbA1c, Week 12 of the Treatment|FPG, Change from Baseline in fasting plasma glucose, Week 12 and 24 of the Treatment|Body weight, Change from Baseline in body weight, Week 12 and 24 of the Treatment
High Intensity Interval Inspiratory Training Effect on Ventilatory Functions and Diaphragmatic Excursion in Forward Head Posture
NCT Number: NCT06571578
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: FHD
Interventions: DEVICE: Threshold Inspiratory muscle trainer|OTHER: posture correction exercises
Sponsor: Cairo University
Sex: FEMALE
Age: ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (CARE_PROVIDER)|Primary Purpose: TREATMENT
Start Date: 2023-05-03
Completion Date: 2024-02-04
Locations: Cairo university, Cairo, Egypt

Summary:
PURPOSE: ......... The purpose of the study is to investigate the effect of interval inspiratory muscle training on respiratory functions in subjects with forward head posture associated with chronic nonspecific neck pain

BACKGROUND: Alteration of head and neck positions can have an immediate negative effect on respiratory function. Clinicians should be prompted to assess respiratory function when assessing individuals with FHP and decrease the tension on respiratory system to avoid consequence. Also FHP has a negative effect on chest expansion and diaphragmatic function

the incidence of forward head posture increases nowadays due to increase using of smartphones HYPOTHESES:: There will be no a significant effect of interval inspiratory muscle training on respiratory functions in chronic forward head posture subjects.

RESEARCH QUESTION: Will the interval inspiratory muscle training improve respiratory functions in subjects forward head posture associated with chronic nonspecific neck pain?

Primary Outcome Measures: improve ventilatory functions, measure ventilatory functions in percentage from predictied using spirometery (Digital-CONTEC-SP10-Spirometer-Lung Breathing-Diagnostic (Made in China), to measure ventilatory function test parameters.changes

* Forced expiratory volume in the first second (FEV1)
* Forced vital capacity (FVC).
* FEV1/FVC ratio
* Peak expiratory flow rate (PEFR)., 3 months|Diaphragmatic execursion, Diaphragmatic sonography model (LOG IQ E10S) for measuring diaphragmatic excursion changes.in centimeter, 3 months|chest expansion tests, Using tape Measurement tool: To measure chest expansion changes in centimetres at the suprasternal notch, at the nipple and xiphoid levels., 3 months
Secondary Outcome Measures: craniocervical angle, • Markings were done with help of Kinovea software. The intersection of a horizontal line passing through C7 spinous process and line joining the midpoint of tragus of ear is known as Craniovertebral angle., 3 months|Body mass index, measuring body mass index kg\\m2 before measuring ventilatory function test by measuring height in centimetres and body weight in kilograms, 3 months
The Effect of Manual Lymph Drainage in Fibromyalgia Patients
NCT Number: NCT06571565
Status: ENROLLING_BY_INVITATION
Study Type: INTERVENTIONAL
Phases: EARLY_PHASE1
Conditions: Fibromyalgia|Oxidative Stress
Interventions: COMBINATION_PRODUCT: conservative treatment
Sponsor: Baskent University
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 44
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2023-12-27
Completion Date: 2026-12-31
Locations: Baskent University, Adana, Çukurova, 01250, Turkey

Summary:
In this randomized controlled single blinded study, our primary objective is to evaluate the effects of manual lymphatic drainage on blood lipid peroxidation system and antioxidant system in FMS patients. For this objective, the following biochemical analyses will be performed to objectively evaluate the effect of manual lymphatic drainage.

Our secondary objective is to evaluate the changes in pain, functional status and sleep quality with manual lymphatic drainage treatment. The evaluator and the investigator working on the antioxidant panel will be blinded.

Primary Outcome Measures: oxidative stress and other biochemical analyzes, To evaluate the effects of manual lymphatic drainage on blood lipid peroxidation system and antioxidant system in FMS patients. For this objective, the following biochemical analyses will be performed to objectively evaluate the effect of manual lymphatic drainage.Blood samples will be taken from the patients before, after and one month after the end of treatment and Paraoxonase (PON1), Oxidative Stress Index (OSI), malondialdehyde (MDA), Rductegulutathione (GSH), Low danditelilipoprotein (LDL), High danditelilipoprotein (HDL) and Triglyceride levels will be evaluated., Both groups will be evaluated before treatment, immediately after treatment and one month after treatment.
Secondary Outcome Measures: Pain evaluation of, Pain will be assessed with the Mcgill-Melzack pain questionnaire., Both groups will be evaluated before treatment, immediately after treatment and one month after treatment.|Functional Status evaluation of, Quality of life and functional status will be assessed with the Fibromyalgia Impact Questionnaire (FEA)., Both groups will be evaluated before treatment, immediately after treatment and one month after treatment.|Sleep quality evaluation of, Sleep quality will be assessed with the Pittsburgh Sleep Inventory (PSI). The PDQI is a scale that provides information about sleep quality and the type and severity of sleep disturbance in the last month., Both groups will be evaluated before treatment, immediately after treatment and one month after treatment.
Augmented Reality-Assisted Neurosurgical Drain Placement
NCT Number: NCT06571539
Acronym: ARANED
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Intracranial Hypertension
Interventions: DEVICE: AR-assisted EVD placement|PROCEDURE: Freehand EVD placement
Sponsor: Universitair Ziekenhuis Brussel
Collaborators: Vrije Universiteit Brussel|Imec|Orsi Academy
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 11
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
Start Date: 2021-08-29
Completion Date: 2023-08-30
Locations: Universitair Ziekenhuis Brussel, Jette, 1090, Belgium

Summary:
The goal of this clinical trial is to learn if high-accuracy augmented reality (AR) guidance for external ventricular drain (EVD) placement using a standalone head-worn navigation system can improve current shortcomings of freehand and image-guidance techniques. It will assess safety, feasibility and clinical performance. The main questions it aims to answer are:

* Is the implementation of a standalone head-worn AR navigation system for EVD placement in critical care settings feasible and safe?
* How does it compare to the conventional freehand technique in terms of EVD placement quality, complication rate and revision rate?

Researchers will assess placement quality using the modified Kakarla scale, grading placement quality based on the position of the EVD tip on postoperative CT imaging. The amount of attempts, complications and revisions will be documented. The results of the AR-guided placements will be compared to a matched, non-concurrent freehand control group.

Participants will undergo AR-guided EVD placement in a critical care setting (i.e. the emergency room or intensive care unit).

Primary Outcome Measures: Clinical EVD placement quality, External ventricular drain (EVD) placement quality assessment using the modified Kakarla scale (mKS; with grades I (a and b), II and III), grading placement quality based on the EVD tip position (identified on the postoperative CT imaging) from optimal placement (mKS grade Ia) to poor or failed placement (mKS grade III)., Within 24 hours after surgery
Secondary Outcome Measures: Required attempts, The number of attempts required for successful ventricular puncture, During surgery|Procedure-related complications, The amount and type of complications related to the EVD placement procedure (e.g. hemorrhage, infection), Within 7 days after surgery|Revision rate, The amount of revisions required in case of non-functional EVD placement, Within 24 hours after surgery
Other Outcome Measures: Subjective technology experience, All participating surgeons will be asked to complete a questionnaire gauging their subjective experience regarding the use of the system (likelihood of technology-acceptance cfr. UTAUT model, subjective ease-of-use, any discomforts), Within 7 days after inclusion of the last patient
External Focus Strategy on Visuomotor Control in Older Adults
NCT Number: NCT06571526
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Gait|Fall Risk|Older Adults
Interventions: BEHAVIORAL: External focus|BEHAVIORAL: Control
Sponsor: The Hong Kong Polytechnic University
Sex: ALL
Age: OLDER_ADULT
Enrollment: 112
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2021-10-01
Completion Date: 2023-06-30
Locations: The Hong Kong Polytechnic University, Hong Kong, 000, Hong Kong

Summary:
Only a few studies have adopted external focus strategy as an intervention to mitigate the negative effects of heightened conscious movement processing in older adults. The goal was to investigate whether a single-session intervention (SSI) using external focus strategy could improve gait stability and visual search behaviors during adaptive locomotion among the older population.

Participants were randomly allocated to either an external focus (EXT) or a control group (CON). All participants performed an obstacle circumvention walking task along an 8-m walkway for five trials at pre-intervention (T0), post-intervention (T1), and retention (T2). The training phase included 20 walking trials. EXT focused on digits displayed on monitors at their path destinations, while CON walked naturally without any manipulation.

Primary Outcome Measures: Gait stability, Measured by a 3-D motion-capture system. Indicated by the variabilities of temporal and spatial gait parameters, pre-test, post-test (the same day, immediately after the single-session intervention), 1 week after post-test (retention)|Visual search behavior, Measured by eye tracker.

Indicated by:

number of fixation (%) on ground number of fixation (%) on destination number of fixation (%) on obstacle number of fixation (%) on random areas fixation duration (%) on ground fixation duration (%) on destination fixation duration (%) on obstacle fixation duration (%) on random areas, pre-test, post-test (the same day, immediately after the single-session intervention), 1 week after post-test (retention)
Growth Hormone Resistance of Beta-cells in Women and People
NCT Number: NCT06571500
Acronym: GHRB-B
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Healthy|Obesity
Sponsor: University of Missouri-Columbia
Sex: ALL
Age: ADULT
Enrollment: 30
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-01
Completion Date: 2030-09-01

Summary:
The purpose of the research study is to better understand how beta-cells (cells in the pancreas that make insulin and help regulate blood sugar) respond to growth hormone in people with a family history of type 2 diabetes at the University of Missouri. Our aim is to advance understanding of how growth hormone affects beta-cells and risk factors for developing gestational diabetes and type 2 diabetes.

Primary Outcome Measures: Beta-cell function, Insulin secretion rate in relationship to plasma glucose, 15, 30, 60, 120, 240, and 360 min and 7 days after rhGH administration
Growth Hormone Resistance of Beta-cells
NCT Number: NCT06571487
Acronym: GHRB-A
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Gestational Diabetes|Obesity|Healthy
Sponsor: University of Missouri-Columbia
Sex: FEMALE
Age: ADULT
Enrollment: 30
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-01
Completion Date: 2030-09-01

Summary:
The purpose of the research study is to better understand how beta-cells (cells in the pancreas that make insulin and help regulate blood sugar) respond to growth hormone in people with a personal history of gestational diabetes (high blood sugar in pregnancy) at the University of Missouri. The aim of the study is to advance understanding of how growth hormone affects beta-cells and risk factors for developing gestational diabetes and type 2 diabetes.

Primary Outcome Measures: Beta-cell function, Insulin secretion rate in relationship to plasma glucose, 15, 30, 60, 120, 240, and 360 min and 7 days after rhGH administration
Harnessing Macrophage Lysosomal Lipid Metabolism in Obesity (ATM)
NCT Number: NCT06571474
Acronym: ATM
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Obesity|Non-Alcoholic Fatty Liver Disease|Diabetes Mellitus, Type 2|Healthy
Sponsor: Bettina Mittendorfer
Collaborators: National Institutes of Health (NIH)|National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)|Washington University School of Medicine
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-01
Completion Date: 2028-03
Locations: University of Missouri School of Medicine, Columbia, Missouri, 65212, United States

Summary:
The goal of this study is to evaluate the role of transcription factor EB (TFEB) in adipose (fat) tissue macrophages (ATM) in regulating adipose tissue and systemic metabolic function in obesity. The investigators will assess the differences in ATM lipid metabolism in people with metabolically abnormal obesity and lean individuals.

Both groups will have:

* screening visit
* imaging (body composition testing - dual-energy x-ray absorptiometry (DEXA) scans, magnetic resonance imaging \[MRI\] and magnetic resonance spectroscopy \[MRS\] scans)
* Overnight visit with intravenous infusion (IV), muscle, and fat tissue biopsies

Primary Outcome Measures: Insulin sensitivity, Sensitivity assessed as insulin-mediated glucose disposal during a hyperinsulinemic-euglycemic clamp procedure, Within 2 weeks of Clinical Visit|24-hour plasma glucose concentration, Within 2 weeks of Clinical Visit|Macrophage isolation in adipose tissue biopsy, macrophage gene expression using RNA sequencing and fluorescent activated cell sorting (FACS), Within 2 weeks of Clinical Visit|Macrophage isolation in skeletal muscle tissue, macrophage gene expression using RNA sequencing and fluorescent activated cell sorting (FACS), Within 2 weeks of Clinical Visit
Liposomal Irinotecan in Combination With Oxaliplatin and S-1 Versus Gemcitabine Combined With Capecitabine as Postoperative Adjuvant Therapy for Pancreatic Cancer
NCT Number: NCT06571461
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Pancreatic Cancer
Interventions: DRUG: Liposomal Irinotecan|DRUG: Oxaliplatin|DRUG: S-1|DRUG: Gemcitabine|DRUG: Capecitabine
Sponsor: CSPC Ouyi Pharmaceutical Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 408
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2029-03

Summary:
This study will evaluate the efficacy and safety of adjuvant therapy with liposomal irinotecan in combination with oxaliplatin, and S-1 compared with capecitabine combined with capecitabine in participants with pancreatic ductal adenocarcinoma after radical surgery.

Primary Outcome Measures: Disease-free survival (DFS), Disease-free survival is defined as the time from the date of randomization to the date of disease recurrence or death from any cause (whichever occurs first). Disease recurrence is defined as evidence of disease recurrence demonstrated by imaging assessment with CT or MRI scan and/or pathological diagnosis indicated by biopsy., Approximately 3 years.
Secondary Outcome Measures: Overall survival (OS), Approximately 5 years.
Relationship Between Modified Closed Kinetic Chain Upper Extremity Stability Test and Shoulder Endurance Test in Young Active and Sedentary Individuals
NCT Number: NCT06571435
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Healthy
Interventions: DIAGNOSTIC_TEST: Closed Kinetic Chain Upper Extremity Stability Test (CKCUEST), and Posterior Shoulder Endurance Test
Sponsor: Acibadem University
Collaborators: Biruni University
Sex: ALL
Age: ADULT
Enrollment: 20
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-14
Completion Date: 2024-10-30
Locations: Acibadem University, Istanbul, Ataşehir, 34752, Turkey

Summary:
This study is planned to examine the relationship between Closed Kinetic Chain Upper Extremity Stability Test (CKCUEST) performance with Posterior Shoulder Endurance Test in healthy young adults. Both tests are frequently used in athletes, but their use in sedentary people is not common in the literature. The feasibility of using these tests in sedentary people is not clear.

Primary Outcome Measures: Closed Kinetic Chain Upper Extremity Stability Test (CKCUEST) Performance, Within 15 seconds, the total number of touches is noted. A total of 3 measurements are taken with a 45-second rest break, 4 weeks|Posterior Shoulder Endurance Test Performance, Participants will lie face down. While the shoulder is hanging from the stretcher, individuals will be asked to lift the dumble calculated with the weight appropriate for their weight to 90 degrees abduction in accordance with the 60 bpm metronome. The time they can continue will be noted. 1 measurement will be made with each arm., 4 weeks
Clinical Evaluation of the Efficacy of a Dietary Supplement Claiming Anti-aging Properties and UV-protection
NCT Number: NCT06571409
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Healthy Volunteers
Interventions: DIETARY_SUPPLEMENT: Coriander Seed Oil - Dose 1|DIETARY_SUPPLEMENT: Coriander Seed Oil - Dose 2|DIETARY_SUPPLEMENT: Placebo
Sponsor: Seppic
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 99
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-25
Completion Date: 2025-01-27
Locations: Complife Italia S.r.l, San Martino Siccomario, 27028, Italy

Summary:
The study aims to assess the anti-aging and photoprotective efficacy of two active concentrations of a food supplement composed of Coriander Seed Oil (CSO).

Primary Outcome Measures: Skin profilometry, Primos 3D, Baseline|Skin profilometry, Primos 3D, 14 days|Skin profilometry, Primos 3D, 28 days|Skin profilometry, Primos 3D, 56 days
Secondary Outcome Measures: Skin elasticity, Cutometer, Baseline|Skin elasticity, Cutometer, 14 days|Skin elasticity, Cutometer, 28 days|Skin elasticity, Cutometer, 56 days|Transepidermal water loss, Tewameter, Baseline|Transepidermal water loss, Tewameter, 14 days|Transepidermal water loss, Tewameter, 28 days|Transepidermal water loss, Tewameter, 56 days|Erythema index, Skin haemoglobin quantification by Mexameter 24h after UV exposure, Baseline|Erythema index, Skin haemoglobin quantification by Mexameter 24h after UV exposure, 28 days|Erythema index, Skin haemoglobin quantification by Mexameter 24h after UV exposure, 56 days|Skin inflammation (subgroup of 20 subjects), TNF-alpha quantification by Enzyme-Linked Immunosorbent Assay on skin stripping performed before and 24h after UV exposure, Baseline|Skin inflammation (subgroup of 20 subjects), TNF-alpha quantification by Enzyme-Linked Immunosorbent Assay on skin stripping performed before and 24h after UV exposure, 56 days|Skin lipoxidation (subgroup of 20 subjects), Malondialdehyde quantification by spectrophotometry on skin stripping performed before and 4h and 24h after UV exposure, Baseline|Skin lipoxidation (subgroup of 20 subjects), Malondialdehyde quantification by spectrophotometry on skin stripping performed before and 4h and 24h after UV exposure, 56 days|Self-assessment of product efficacy, Questionnaire (10 questions with 4 possible answers : completely agree / agree / disagree / completely disagree), 56 days
Perioperative Risk of Immunotherapy Based Neoadjuvant and Conversion Therapy for Hepatocellular Carcinoma
NCT Number: NCT06571396
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Carcinoma, Hepatocellular|Immunotherapy
Sponsor: Qilu Hospital of Shandong University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Observational Model: |Time Perspective: p
Start Date: 2014-04-01
Completion Date: 2026-08-03
Locations: Qilu hospital of Shandong university, Jinan, Shandong, 250012, China

Summary:
This study aims to retrospectively collect a cohort of participants with hepatocellular carcinoma who received immunotherapy-based neoadjuvant/translational treatment. A multi-dimensional and multi-method analysis plan will be adopted. The goal is to provide solutions for better application of neoadjuvant immunotherapy and to offer better evidence for conducting prospective clinical research on hepatocellular carcinoma.

Primary Outcome Measures: Perioperative risk, The criteria for perioperative risk include four aspects: operation time, transfusion, postoperative hospital stay, and complication. Operation time \>200min is counted as 3 points, transfusion is counted as 2 points, postoperative hospital stay \>8 days is counted as 2 points, and complication is counted as 1 point. The total score range is 0-8 points. Participants with a score of 3 or lower are considered to have a low perioperative risk, while those above 3 are considered to have a high perioperative risk., From enrollment to the end of surgery at 4 weeks
Secondary Outcome Measures: Progression free survival time, The time between the end of surgery and tumor progression ( in any way ) or death ( for any reason ), From enrollment to the end of surgery at 12 months|Overall survival time, The time from the end of surgery to death ( for any reason ), From enrollment to the end of surgery at 36 months
Vitamin D in Dialysis Patients - Diagnostic and Therapeutic Management
NCT Number: NCT06571344
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Vitamin D Deficiency Due to Chronic Kidney Disease
Interventions: DRUG: Cholecalciferol
Sponsor: Medical University of Gdansk
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 160
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-11-01
Completion Date: 2026-12-31
Locations: Medical University of Gdansk, Gdańsk, 80-211, Poland

Summary:
The goal of this observational study is to learn about the effects of cholecalciferol administration, according to guidelines for the general population, on laboratory parameters of Chronic Kidney Disease-Mineral and Bone Disorder in dialysis patients, depending of the attained levels of vitamin D (25OH)D).

The main question it aims to answer is:

How does cholecalciferol affect calcium and phosphate metabolism parameters depending on the achieved levels of 25(OH)D?

Participants taking cholecalciferol as part of their regular medical care for CKD-MBD will have the laboratory result parameters observed for up to 4 years.

Primary Outcome Measures: efficacy and safety of cholecalciferol therapy in dialysed patients, analysis of - vitamin D levels - 25(OH)D, 1,25(OH)2D, calcium-phosphate metabolism parameters (serum calcium, phosphate, PTH levels),FGF23, GDF15 levels, in 3 groups of patients achieving different range of 25(OH)D levels, 2022-2026
FAMILY Sleep Program
NCT Number: NCT06571305
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cancer
Interventions: BEHAVIORAL: Brief Behavioral Treatment for Insomnia (BBTI)|BEHAVIORAL: My Sleep Our Sleep (MSOS)
Sponsor: University of Miami
Collaborators: Community Foundation for Brevard
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 36
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-10-01
Completion Date: 2026-10-01
Locations: University of Miami, Coral Gables, Florida, 33146, United States

Summary:
The purpose of this study is to learn about sleep behaviors and test different ways to help patients with cancer and partners. Participants (patient-sleep-partner caregivers dyads as a unit) participate in the study together.

Primary Outcome Measures: Proportion of participants adapting to BBTI, The proportion of participants (patient--sleep-partner caregiver dyads) who adapt to Brief Behavioral Treatment for Insomnia (BBTI)., Up to 4 weeks|Change in Sleep Disturbance Symptoms Measured by Pittsburgh Sleep Quality Index (PSQI), The proportion of participants (patient-sleep-partner caregiver dyads) experiencing a change in sleep disturbance symptoms will be compared and reported for both intervention groups, BBTI and MSOS, as measured by scores on the Pittsburgh Sleep Quality Index (PSQI) health-related quality of life HRQOL) questionnaire. The PSQI is a self-reported, 19-item questionnaire which assesses sleep quality and disturbances at baseline and over a four week period. Questions generate seven "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The sum of scores for these seven components yields one global score. The PSQI global score has a possible range of 0-21 points. A total score of 5 or above indicates overall poor sleep quality., Baseline, Up to 4 weeks
Impact of Plant Diet for Diabetes Prevention
NCT Number: NCT06571279
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Diabetes
Interventions: OTHER: Plant-based diet
Sponsor: Jean L. Fry
Sex: ALL
Age: ADULT
Enrollment: 6
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-09
Completion Date: 2027-12-31
Locations: University of Kentucky, Lexington, Kentucky, 40536, United States

Summary:
The primary purpose of this study is to determine the sex-specific metabolic and molecular response, among adults with prediabetes, when moving from a Western Diet to plant-based diet.

Primary Outcome Measures: Absolute change in Matsuda Insulin Sensitivity Index (Mat-ISI), Mat-ISI is a measure of insulin sensitivity derived from insulin and glucose values taken during a standard oral glucose tolerance test. The method approximates insulin sensitivity as determined by a hyperinsulinemic-euglycemic clamp, The first measure is taken after the run-in and the final measure will be taken 5 weeks later after the completion of the plant-based diet intervention.
Secondary Outcome Measures: Change in concentration of myoinositol and D-chiro inositol (MI and DCI) in skeletal muscle, Upon insulin stimulation, skeletal muscle MI is converted to DCI, which is a component of molecules involved in non-canonical insulin signaling pathways. The concentration of MI and DCI will be determined though the use of skeletal muscle tissue obtained during a muscle biopsy and will be evaluated via mass spectrometry using a standard amount of skeletal muscle., The first measure is taken after the run-in and the final measure will be taken 5 weeks later after the completion of the plant-based diet intervention.|Change in phosphorylation status of insulin signaling molecules in skeletal muscle, Upon insulin stimulation, insulin-responsive signaling proteins are phosphorylated to initiate downstream effects. The ratio of phosphorylated and unphosphorylated, as well as total protein, per standard unit of skeletal muscle will be determined., The first measure is taken after the run-in and the final measure will be taken 5 weeks later after the completion of the plant-based diet intervention.|Absolute change in visceral fat (g), Dual-energy X-ray absorptiometry will be used to approximate visceral fat, The first measure is taken after the run-in and the final measure will be taken 5 weeks later after the completion of the plant-based diet intervention.
A Study to Assess the Relative Bioavailability of Two Formulations of Risankizumab Following Subcutaneous Administration With Prefilled Syringes in Healthy Adult Participants
NCT Number: NCT06571266
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Healthy Volunteers
Interventions: DRUG: Risankizumab
Sponsor: AbbVie
Sex: ALL
Age: ADULT
Enrollment: 231
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-09-10
Completion Date: 2025-04-17

Summary:
This study will assess the pharmacokinetics, relative bioavailability and tolerability of two formulations of risankizumab following subcutaneous (SC) administration in healthy adult participants.

Primary Outcome Measures: Number of Participants with Adverse Events (AEs), An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment., Up to day 140|Maximum Observed Serum Concentration (Cmax) of Risankizumab, Cmax will be assessed of Risankizumab, Up to Day 140|Time to Cmax (Tmax) of Risankizumab, Tmax will be assessed of Risankizumab, Up to Day 140|Apparent Terminal Phase Elimination Rate Constant (β) of Risankizumab, Apparent terminal phase elimination rate constant (β) will be assessed of Risankizumab, Up to Day 140|Terminal Phase Elimination Half-life (t1/2) of Risankizumab, Terminal phase elimination half-life (t1/2) will be assessed of Risankizumab, Up to Day 140|Area Under the Concentration-time Curve (AUC) from Time 0 to Time of the Last Measurable Concentration (AUC0-t), AUC0-t will be assessed, Up to Day 140|AUC from Time 0 to Infinity (AUC0-inf) of Risankizumab, AUC0-inf will be assessed of Risankizumab, Up to Day 140|Number of Anti-drug antibody (ADA) Titers, Incidence and concentration of anti-drug antibodies, Up to Day 140