pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
The Effects of the Intrapartum Care Model Given in Line With the Recommendations of the World Health Organization (WHO)
NCT Number: NCT06551571
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Birth Outcome, Adverse|Breast Feeding|Parenting
Interventions: OTHER: Intrapartum Care Model
Sponsor: Selcuk University
Sex: FEMALE
Age: ADULT
Enrollment: 128
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-01-01
Completion Date: 2024-06-01
Locations: Seyhan Çankaya, Konya, 42250, Turkey

Summary:
The objective of this study was to examine the impact of the intrapartum care model that adheres to the guidelines set forth by the World Health Organization (WHO) on several key outcomes, including the mother's maternal behavior towards her infant postpartum, breastfeeding self-efficacy, the success of breastfeeding, and the mother's readiness for hospital discharge.

Primary Outcome Measures: Comparison of pre-intervention sociodemographic of pregnant women., Sociodemographic of pregnant women will be collected through surveys and compared and reported, 6 months|Comparison of pre-intervention obstetric features of pregnant women, Obstetric of pregnant women will be collected through surveys and compared and reported., 6 months|Comparison of postpartum characteristics of pregnant women, Postpartum characteristics of pregnant women will be collected through surveys and compared and reported., 6 months|Comparison of mother's postpartum parenting behavior towards her baby mean scores by groups, The postpartum parenting behavior scale will be applied to mothers. The postpartum parenting behavior scale is 0-6 points (min-max) and as the score increases, the level of positive parenting behaviors of mothers towards their babies increases., 6 months|Comparison of mother's breastfeeding self-efficacy scale mean scores by groups, The breastfeeding self-efficacy scale will be applied to mothers. The breastfeeding self-efficacy scale is 14-70 points (min-max) and as the score increases, the breastfeeding self-efficacy of the mothers increases., 6 months|Comparison of mother's A Breastfeeding Charting System and Documentation Tool (LATCH) mean scores by groups, The Breastfeeding Charting System and Documentation Tool (LATCH) will be applied to mothers.

The LATCH is 0-10 points (min-max) and as the score increases, the LATCH of the mothers increases., 6 months|Comparison of mother's readiness for hospital discharge scale-new mother form mean scores by groups, The readiness for hospital discharge scale-new motherwill be applied to mothers.

The readiness for hospital discharge scale-new mother is 0-220 points (min-max) and as the score increases shows that the mothers is sufficiently ready for discharge., 6 months
Tryptophan Metabolism in Healthy Young Adults
NCT Number: NCT06551545
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Healthy
Interventions: DIETARY_SUPPLEMENT: Tryptophan intake
Sponsor: The Hospital for Sick Children
Collaborators: Canadian Institutes of Health Research (CIHR)
Sex: MALE
Age: ADULT
Enrollment: 6
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-09-01
Completion Date: 2024-12-31
Locations: The Hospital for Sick Children, Toronto, Ontario, M5G 1E8, Canada

Summary:
Tryptophan is an essential amino acid needed for growth and bodily functions. It is used to make serotonin which is needed for the brain to develop and function properly. However, when the body is stressed, tryptophan is broken down into compounds that can cause harm to the brain. Premature babies who get nutrition through their vein \[i.e. total parenteral nutrition (TPN)\] can experience this type of stress. The amount of tryptophan in TPN solutions is much higher than what premature babies need and can produce too much harmful compounds. So, it is important to study the amount of these compounds made from tryptophan. But there are no methods available to study this. Therefore, the goal of this study is to develop a method to measure the compounds made from tryptophan breakdown in adults so that it can be used for preterm babies on TPN later.

Primary Outcome Measures: Fractional Synthesis Rate (FSR) of tryptophan metabolites, Enrichment of L-\[15N2\]tryptophan and its metabolites (15N2-L-kynurenine, 15N-kynurenic acid, 15N-quinolinic acid, 15N2-serotonin and 15N-5-hydroxyindole acetic acid) in plasma and urine following orally administered tracer, L-\[15N2\]tryptophan., 10 hours|Steady state, Time at which plasma and urine enrichment of L-\[15N2\]tryptophan reaches steady-state., 10 hours
Secondary Outcome Measures: Partitioning of tryptophan metabolism, Partitioning of tryptophan between kynurenine and serotonin pathway at tryptophan intake below and above requirements, 10 hours|Fractional synthesis rate (FSR), Fractional synthesis rate (FSR) of metabolites of tryptophan (15N2-L-kynurenine, 15N-kynurenic acid, 15N-quinolinic acid, 15N2-serotonin and 15N-5-hydroxyindole acetic acid) at isotopic steady state, 10 hours
"Ecological Program Changes Pelvic Kinematics in Soccer Players: Pilot Study on Hamstring Injury Implications"
NCT Number: NCT06551532
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Anterior Pelvic Tilt|Sprint Kinematics
Interventions: OTHER: Multicomponent program
Sponsor: RX2 Sports and Health
Sex: MALE
Age: ADULT
Enrollment: 17
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2023-01-06
Completion Date: 2024-08-07
Locations: RX2 Sports and Health, Madrid, 28223, Spain

Summary:
The present pilot study aimed to investigate whether a 6-week multicomponent intervention, comprising a structural lumbopelvic and sprint technique program, could reduce anterior pelvic tilt in soccer players who regularly participated in soccer practice.

Primary Outcome Measures: Anterior Pelvic Tilt (APT) Reduction., The primary outcome measure is the reduction in static anterior pelvic tilt (APT) immediately after 6 weeks of the multicomponent intervention. APT is measured using a three-dimensional kinematic analysis during static and high-speed running tasks. The reduction in APT will be assessed before (PRE) and immediately after (POST) the intervention period to determine the effectiveness of the intervention in modifying pelvic alignment., Baseline (PRE) and immediately after 6 weeks of intervention (POST).
Secondary Outcome Measures: biomechanical variables during high-speed running (HSR) and high-speed soccer running (HSSR) tasks, "This outcome measure assesses changes in specific biomechanical variables, including segment orientations (trunk, pelvis, femur, and tibia) relative to the sagittal plane, and joint angles (hip flexion and knee flexion) during high-speed running (HSR) and high-speed soccer running (HSSR) tasks. The study aims to evaluate the shift towards a more front-side oriented sprint technique model and the associated improvements in sprint performance time. Measurements will be taken using three-dimensional motion capture analysis to quantify the kinematic changes during HSR and HSSR.", Baseline (PRE) and immediately after 6 weeks of intervention (POST).
Postnatal Perineal Wound Assessment
NCT Number: NCT06551493
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Perineum; Wound
Interventions: OTHER: Observation of postnatal wound assessment|OTHER: Interview
Sponsor: Oxford Brookes University
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-10
Completion Date: 2025-08

Summary:
Around 85% of women who give birth vaginally experience a perineal wound, which could be a tear or an incision between the vaginal opening and the anus. Despite that, there is often insufficient exploration of how postnatal perineal wound assessment is conducted in healthcare research.

Clinical guidelines from the National Institute for Health and Care Excellence (NICE) touch on the typical signs of wound infection but do not offer detailed guidance on the execution of perineal assessment. Existing research evidence is mostly focused on long-term complications, management of perineal trauma immediately after birth or severe perineal trauma. The limited research on perineal wound care highlights how poor communication and information provision harm women at a physical and psychological level, negatively affecting daily tasks such as caring for their newborns.

Although there have been few studies examining women's or midwives' perspectives on perineal wound assessment in the context of uncomplicated wounds, their perspectives have never been jointly investigated to produce a comprehensive overview. Moreover, no research has had a clinical focus, investigating how the assessment is conducted in practice and what informs this practice, except from women's reports of perceived sub-standard care received.

Therefore, this proposed research is clinically grounded and aims to explore women's and midwives' perspectives on postnatal perineal wound assessment. This is needed to identify evidence-based practices, or lack thereof, in order to determine ways in which the experience can be improved for women and to have a more positive impact on their wellbeing.

Eight to ten pairs of midwives-women will be first observed whilst the routine assessment is conducted to understand what happens during this episode of care, and then they will be separately interviewed within a few days to gather further understanding. Recruitment will be in a single centre, which is a tertiary unit in the UK.

Primary Outcome Measures: Survey. How midwives conduct postnatal perineal wound assessment step-by-step., 10 days postnatal|Survey women's experiences of postnatal perineal wound assessment, i.e. emotional or physical discomfort., 10 days postnatal
VCSEL Based Optical Swept Source Biometry
NCT Number: NCT06551480
Acronym: VBOB
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cataract|Myopia
Interventions: DEVICE: Biometry
Sponsor: Rainer Leitgeb
Collaborators: Mein Hanusch-Krankenhaus
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2021-08-27
Completion Date: 2024-05-01
Locations: Medical University of Vienna, Vienna, 1090, Austria

Summary:
Optical interferometric biometry is a non-invasive and highly precise method for measuring eye length and intraocular distances. The method already exists as commercial devices (e.g. IOLMaster, Carl Zeiss Meditec AG). A major cost factor of the devices available on the market is the laser used. The use of a much cheaper laser could significantly reduce the price of these devices, which would lead to greater availability of this technology in developing countries. This would make it possible to replace the ultrasound methods used to date and thus enable contact-free measurements, which in turn can reduce the spread of infectious diseases.The study investigates the use of a thermally tunable vertical cavity surface emitting laser (VCSEL) for optical swept source biometry.

Primary Outcome Measures: axial length, limits of agreement between the optical biometers (mm), 1 day|anterior chamber depth, limits of agreement between the optical biometers (mm), 1 day
Secondary Outcome Measures: intraocular distances, repeatability on the VCSEL swept source biometer for axial length, anterior chamber depth, corneal thickness, and lens thickness, 1 day
Effect of an Innovative Online Ayurveda Program on the Mental and Physical Health of Home-Based Adults
NCT Number: NCT06551467
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Anxiety|Depression
Interventions: BEHAVIORAL: Online Ayurveda Program for Detox and Lifestyle
Sponsor: Maharishi International University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 98
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2021-03-10
Completion Date: 2022-07-25
Locations: The Center for Maharishi AyurVeda and Holistic Medicine, Geboltskirchen, 4682, Austria

Summary:
The overall objective of this study is to evaluate the effects, feasibility, and safety of a comprehensive online Ayurveda whole-systems (WS) intervention that targets the underlying etiological factors influencing mental and physical health symptoms. The primary hypothesis is that home-based adults who participate in the Ayurveda Program for Detox and Lifestyle will experience a decrease in anxiety and depression symptoms over 4 months.

Primary Outcome Measures: Change in Anxiety Score, Assessed using the online standardized Patient Health Questionnaire for Somatic, Anxiety, and Depressive Symptoms (PHQ-SADS). The PHQ-SADS uses cut-off points of 5, 10, and 15 to represent mild, moderate, and severe symptoms, respectively., Assessed at baseline and once a month for four months|Change in Depression Score, Assessed using the online standardized Patient Health Questionnaire for Somatic, Anxiety, and Depressive Symptoms (PHQ-SADS). The PHQ-SADS uses cut-off points of 5, 10, and 15 to represent mild, moderate, and severe symptoms, respectively., Assessed at baseline and once a month for four months
Secondary Outcome Measures: Change in Somatic or Physical Symptoms Score Change in Somatic or Physical Symptoms Score, Assessed using the online standardized Patient Health Questionnaire for Somatic, Anxiety, and Depressive Symptoms (PHQ-SADS). The PHQ-SADS uses cut-off points of 5, 10, and 15 to represent mild, moderate, and severe symptoms, respectively., Assessed at baseline and once a month for four months|Change in Fatigue Score, Measured using the PROMIS Fatigue Short Form (PROMIS), Assessed at baseline and once a month for four months|Changes in Body Mass Index (BMI), Participants measured their height and weight using a standard scale and tape, and then reported these in the online survey. BMI was calculated using a standardized formula in an Excel program., Assessed at baseline and once a month for four months
The Effect of Sleep Quality on Mental and Physical Health
NCT Number: NCT06551428
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Mental and Physical Health
Sponsor: Ahmed Ali Mohammed Torad
Sex: ALL
Age: CHILD, ADULT
Enrollment: 380
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-10-01
Completion Date: 2024-10-21
Locations: Kafrelsheikh University, Kafr Ash Shaykh, 33516, Egypt|Kafrelsheikh University, Kafr Ash Shaykh, 33516, Egypt

Summary:
This study aimed to explore the relationship between sleep quality and its impact on mental and physical health, particularly in the context of stress.

A mixed methods approach will be used including:

a pre-test questionnaire and physiological measurements that depend on scales for measuring to assess sleep patterns: DASS21, fatigue assessment scale, Epworth sleeping scale, and SF-12 health survey scoring.

All of that will highlight the importance of addressing sleep quality as a crucial factor in promoting overall well-being.

Primary Outcome Measures: Stress, Week|Sleep quality, Week|Mental and physical health, 4 weeks|Fatigue, Week
Follow-up of the Systemic Lupus Erythematosus Cohort as Part of the Multidisciplinary Consultation at Brest CHRU
NCT Number: NCT06551389
Acronym: COLUPUS
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Systemic Lupus Erythematosus
Sponsor: University Hospital, Brest
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 300
Study Design: Observational Model: |Time Perspective: p
Start Date: 2017-01-17
Completion Date: 2027-01-17
Locations: CHRU de Brest, Brest, 29609, France

Summary:
Systemic lupus erythematosus is a complex systemicautoimmune disease that can affect most organs of the human body.

Although they are many recommendations on the diagnosis and managment of SLE, diagnosis and therapeutic managment is still challenging.

A pluridisciplinary consultation grouping rheumatologist, nephrologist, dermatologist, gynecologist, internist and immunologists has been set up in 2009 at the university hospital of Brest.

The investigators would like to identify in a longitudinal cohort the occurrence of the different clinico-biological and immunological patterns of systemic lupus erythematosus patients during our multidisciplinary consultation.

It is now crucial to organize a standardized data collection of these patients in order to evaluate our pratices, to be able to study the epidemiology of SLE in our city, and to promote this initiative at national and international level.

Primary Outcome Measures: Cohort data, Prevalence and incidence of the clinico-biological and immunological patterns in a longitudinal cohort present in the standardized collection book including evaluation of différents criteria aspects : SLICC criteria, one year|Cohort data, Prevalence and incidence of the clinico-biological and immunological patterns in a longitudinal cohort present in the standardized collection book including evaluation of différents criteria aspects : SLEDAI score, one year|Cohort data, Prevalence and incidence of the clinico-biological and immunological patterns in a longitudinal cohort present in the standardized collection book including evaluation of différents criteria aspects : SDI score, one year
LATE LUTEAL PHASE VS. CONVENTIONAL EARLY FOLLICULAR PHASE START IN IVF
NCT Number: NCT06551376
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: IVF
Interventions: OTHER: Ovarian Stimulation Start
Sponsor: Clinia de fertilización Asistida en el Hospital ABC
Sex: FEMALE
Age: ADULT
Enrollment: 40
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2025-01-31

Summary:
To compare cycle outcomes after scheduling with the standard early follicular phase (EFP) versus late luteal phase (LLP) in patients undergoing GnRH antagonist cycles.

Primary Outcome Measures: mature oocytes retrieved, At retrieval
Secondary Outcome Measures: fertilization rate, 24 hours after retrieval|viable embryo rate per oocyte retrieved, 5 days after retrieval|cancellation rate, 14 days after cycle start
Atopic Dermatitis Cutaneous Discomfort of the Infant Under the Age of One Year : Analysis of Filmed Sequences (PRE-PRURINEO)
NCT Number: NCT06551363
Acronym: PRE-PRURINEO
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Atopic Dermatitis
Sponsor: University Hospital, Brest
Sex: ALL
Age: CHILD
Enrollment: 7
Study Design: Observational Model: |Time Perspective: p
Start Date: 2018-03-01
Completion Date: 2018-04-26
Locations: CHRU de Brest, Brest, 29609, France

Summary:
Analysis of filmed sequences for the assessment of discomfort in atopic dermatitis in infants under 1year of age

Primary Outcome Measures: Focal sampling and Scan sampling of the behaviors, Frequency of behaviors observed by the method of "focal sampling" and "scan sampling".

All behavioral responses of the infants will be quantified from the video recordings., 6 month
Secondary Outcome Measures: Frequency of behaviors according to the severity of atopic dermatitis, Frequency of focal sampling behaviors according to the severity of atopic dermatitis evaluated using SCORAD score All behavioral responses of the infants will be quantified from the video recordings., 6 month
Vitamin D Replacement in Bronchiectasis
NCT Number: NCT06551337
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Bronchiectasis
Interventions: DRUG: Vitamin D3
Sponsor: Queen Mary Hospital, Hong Kong
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 104
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-04-17
Completion Date: 2027-06-30
Locations: Queen Mary Hospital, Hong Kong, Hong Kong

Summary:
This study seeks to address the limitations in previous related studies on vitamin D replacement and bronchiectasis exacerbation occurrence through a self-controlled pilot study. The investigators aim to investigate whether vitamin D replacement in bronchiectasis patients with vitamin D deficiency can reduce hospitalized bronchiectasis exacerbation occurrence. Patients who participated in the prior study entitled "Prospective clinical study on serum 25-hydroxyvitamin D (25-OH D) level and risk of bronchiectasis exacerbation" (UW 22-317) will be invited for participation during regular clinic follow-up and management in Queen Mary Hospital. If participants are willing to join the further research, participants will be recruited in this self-controlled study. There are some differences from usual management to non-CF bronchiectasis subjects. The study subjects would be checked for their blood 25-hydroxyvitamin-D level during the study period. The non-CF bronchiectasis subjects with Vitamin D deficiency would be given 1000 IU and 2000 IU (if needed). The investigators aim to correct their Vitamin D deficiency completely, aiming at blood 25-hydroxyvitamin-D level \>=50, i.e. treat to target. The dose depends on the level of Vitamin D after replacement. If blood 25-hydroxyvitamin-D level is 50 or above, then 1000 IU is suffice. If blood 25-hydroxyvitamin-D level is still below 50, the investigators will increase to 2000 IU.

Primary Outcome Measures: Proportion of patients who develop hospitalized bronchiectasis exacerbation, The proportion of patients who develop hospitalized bronchiectasis exacerbation during the follow-up period of 12 months, when compared with the 1-year period before., From 1-year period before baseline to 12 months
Secondary Outcome Measures: Change in St. George's Respiratory Questionnaire (SGRQ) score, Scores range from 0 to 100, with higher scores indicating more limitations., From baseline to 6 and 12 months.|Change in bronchiectasis impact measure (BIM) score, A score ranges from 0 to 10 for each of eight domains consists of cough, sputum, breathlessness, tiredness, activity, general health, control, and exacerbation, with 10 being most severe., From baseline to 6 and 12 months.|Change in Bronchiectasis Health Questionnaire (BHQ) score, The instrument comprises 10 questions, each scored on a 7-point scale, to assess quality of life related to bronchiectasis on individuals for a recall period of 2 weeks. The total score ranges from 10 to 70, with a lower score indicating a more negative impact on health-related quality of life (HRQOL)., From baseline to 6 and 12 months.
Multi Center Clinical Study on the Lipid-lowering Efficacy and Safety of Menggongzi Tibetan Tea Special Drink
NCT Number: NCT06551298
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Hyperlipidemias
Interventions: OTHER: Menggongzi Tibetan Tea Special Drink|DRUG: Atorvastatin Calcium 20Mg Tab|OTHER: Low fat diet
Sponsor: The First Affiliated Hospital with Nanjing Medical University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 129
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-08
Completion Date: 2025-08-08
Locations: First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, 210000, China

Summary:
About 179 million people die from cardiovascular disease each year, accounting for approximately 31% of global deaths. It is expected that this number will exceed 236 million by 2030, and the economic burden caused by this disease is increasing year by year.At present, the number of people suffering from cardiovascular diseases in China is as high as 330 million, and the mortality rate accounts for more than 40% of the total deaths caused by diseases, and is in a continuous upward trend.Long term dyslipidemia will increase the incidence rate and mortality of atherosclerotic diseases.Tibetan tea contains catechins, caffeine, amino acids, vitamins, and various mineral components, which have significant effects in reducing cholesterol, improving carbohydrate metabolism, lowering blood sugar, losing weight, softening human blood vessels, and other aspects.At present, there are no research reports on the lipid-lowering effect of Mongolian Gongzi Tibetan Tea Special Drink, and most studies on the lipid-lowering effect of Tibetan Tea are animal experiments or clinical observational studies. Therefore, this study intends to use a randomized controlled trial to explore the lipid-lowering efficacy and safety of Mongolian Gongzi Tibetan Tea Special Drink in patients with hyperlipidemia.

Primary Outcome Measures: TC, Comparison of TC levels between Tibetan tea and a simple low-fat diet compared to baseline, 4 weeks|TG, Comparison of TG levels between Tibetan tea and atorvastatin compared to baseline, 4 weeks
Safety and Efficacy of 9MW2821 in the Treatment of High-risk Non-muscle-invasive Bladder Cancer (NMIBC)
NCT Number: NCT06551233
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Bladder Cancer
Interventions: DRUG: 9MW2821
Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-04-22
Completion Date: 2025-12-31
Locations: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Nanjing, Jiangsu, China

Summary:
Assess the safety and efficacy of 9MW2821 in patients with high-risk non-muscle-invasive bladder cancer (NMIBC) who have previously failed to intravesical therapy. Provide a new treatment option for patients with NMIBC recurrence, reduce the risk of tumor recurrence, decrease the rate of radical bladder surgery, and enhance the quality of life for patients.

Primary Outcome Measures: Safety and tolerability, assess the incidence of AE/SAE, up to 12 months|RP2D and MTD, Determine the recommended phase 2 dose (RP2D) and the maximum tolerated dose (MTD) that may occur., up to 12 months
Secondary Outcome Measures: DFS rate of 12 months, Disease-free survival rate of 12 months, Up to 12 months|DoR of CR, Duration of complete response, Up to 20 months|CR rate of 3/6/12 months, Complete response rate of 3/6/12 months, Up to 12 months|DFS, Disease-free survival, Up to 20 months|Duration to radical cystectomy, Duration to radical cystectomy, Up to 20 months|Proportion of radical cystectomy, Proportion of radical cystectomy, Up to 20 months|Biomarker parameter, Expression of Nectin-4, Up to 20 months
Cadonilimab Combined With Fruquintinib and SBRT as Athird-line and Posterior Line Treatment in Patients With MSS CRC
NCT Number: NCT06551207
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Metastatic Colorectal Cancer
Interventions: DRUG: Fruquintinib|DRUG: Cadonilimab|RADIATION: SBRT
Sponsor: Liu Huang
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-20
Completion Date: 2027-12-30
Locations: Huazhong University of Science and Technology, Wuhan, Hubei, 430000, China

Summary:
An assessment of 6-month progression-free survival in patients with mCRC with third-line and postline metastatic colorectal cancer in combination with cardonilizumab and fuquinitinib and SBRT compared with fuquinitinib monotherapy

Primary Outcome Measures: Progression-free survival, 6-month progression-free survival in patients with third-line and postline metastatic colorectal cancer mCRC with cardonilizumab combined with fuquinitinib and SBRT compared with fuquinitinib monotherapy (6mon-PFS), 6mon-PFS
Secondary Outcome Measures: Obiective response rate (ORR), CR + PR rate according to the RECIST version 1.1 guidelines., up to 42 months]|Disease control rate (DCR), Disease control rate (DCR):CR + PR + SD rate according to the RECIST version 1.1 guidelines., up to 42 months]|Overall survival (OS), The time interval between the start date of study drug and the date of death (any cause), up to 42 months]|quality of life (QOL), OOL according to OOL-C30, up to 42 months]|AEs, Adverse reactions refer to the occurrence and development of diseases in the process of using drugs according to normal usage and dosage to prevent, diagnose or treat diseases. Adverse reactions unrelated to the purpose of treatment., up to 42 months]
Prevalence, Characteristics, Management, and Outcomes of Difficult-to-treat Inflammatory Bowel Disease
NCT Number: NCT06551194
Acronym: DTT-IBD
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Assessment of the Criteria and Risk Factors for DTT-IBD
Interventions: OTHER: prevalence of difficult-to-treat IBD
Sponsor: IRCCS Ospedale San Raffaele
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 972
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-01
Completion Date: 2024-12
Locations: IRCCS San Raffaele, Milan, 20132, Italy

Summary:
Crohn's disease (CD) and ulcerative colitis (UC) are the two main types of chronic inflammatory bowel disease (IBD). Despite recent advances, many patients do not respond to available treatments and or lose response over time.

In 2023, the International Organisation for the Study of IBD (IOIBD) proposed a common definition of 'difficult-to-treat' inflammatory bowel disease (IBD-IBD) to homogenise terminology and promote research into patients most in need of new treatments and therapeutic strategies. According to the IOIBD criteria, IBD is defined by any of the following: failure of two or more advanced treatments with different mechanisms of action, postoperative recurrence of Crohn's disease after two or more bowel resections, pouchitis refractory to antibiotics, complex perianal Crohn's disease, or the presence of psychiatric comorbidity that prevents adequate therapeutic management.

As the definition of DTT-IBD is very recent, the prevalence and risk factors of DTT-IBD are not yet known. This study aims to determine the prevalence of DTT-IBD in the patient population and the risk factors associated with the development of DTT-IBD. The study will be conducted as a retrospective cross-sectional study in two large tertiary care centers, IRCCS Ospedale San Raffaele and IRCCS Humanitas Research Hospital, both in Milan, Italy. The study will evaluate the criteria and risk factors for DTT-IBD in the latest available gastroenterological examination report, provided it was performed in the last 5 years (from 1 January 2019).

Primary Outcome Measures: IBD not meeting the DTT-IBD criteria, In absence of prior literature describing the prevalence of DTT (our will be the first study) a sample size calculation can only be estimated based on clinical experience.

Based on our clinical experience, assuming a Cohen effect size of 0.18, using a two-sided t-test with an alfa error of 0.05, 486 subjects in each group would be needed to detect a significant difference between the two (DTT and non-DTT). Therefore the total included population would be 486 x 2 = 972 patients., 3 months
Heat Acclimation in Females
NCT Number: NCT06551168
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Heat Exposure|Blood Volume|Cardiac Output
Interventions: OTHER: Heat exposure|OTHER: Control group
Sponsor: Trinity Western University
Sex: FEMALE
Age: ADULT
Enrollment: 14
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-09-01
Completion Date: 2026-04-24
Locations: Trinity Western Unversity, Langley, British Columbia, V2Y 1Y1, Canada

Summary:
Heat acclimation is when you repeatedly exposure yourself to heat so that your body adapts and better tolerates heat.

This project will determine if completing a heat acclimation maintenance period after heat acclimation is more beneficial than heat acclimating alone for exercise performance in the heat. To determine this, participants will exercise in the heat before heat acclimation, after heat acclimation, and after heat acclimation maintenance. Researchers will assess the heart's pumping capacity, blood volume, body temperature, and exercise performance to determine which approach is more effective.

Primary Outcome Measures: Performance, Participants will complete a timetrial on a cycle ergometer in a heat chamber. Faster times following HA or HAM will be considered a marker of performance, 2 weeks and 5 weeks
Secondary Outcome Measures: Intravascular volumes, Expanded plasma volume or increased hemoglobin mass will be considered a positive response to heat acclimation, 2 weeks and 5 weeks
Peripheral Mononuclear Cells to Screen, Monitor and Stratify the Population at Risk of Osteoporosis and Fractures
NCT Number: NCT06551155
Acronym: DISCERN
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Osteoporosis|Osteopenia|Osteoporosis Fracture
Interventions: DIAGNOSTIC_TEST: Vitality and biological activity of peripheral blood mononuclear cells (PBMCs)
Sponsor: Istituto Ortopedico Rizzoli
Collaborators: Azienda Ospedaliero Universitaria Policlinico G.Rodolico - San Marco
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 120
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-05
Completion Date: 2026-08-05
Locations: Istituto Ortopedico Rizzoli, Bologna, 40136, Italy|Azienda Ospedaliero Universitaria Policlinico G.Rodolico - San Marco, Catania, 95123, Italy

Summary:
Osteoporosis (OP) is one of most common age-associated and chronic metabolic bone diseases, featured by a decrease of bone mineral density (BMD) that increases the risk of bone fractures.OP guidelines agree that Dual-X-ray Absorptiometry (DXA) is the gold standard for BMD assessment, but for the different OP stages screening and diagnosis, BMD by itself is not an accurate predictor. Thus, OP is often misdiagnosed. Aim of the this study is to improve a tool for OP diagnosis based on the ability of circulating peripheral blood mononuclear cells (PBMCs) to maintain or not their in vitro viability (IRCCS Istituto Ortopedico Rizzoli European patent n.3008470 March 21, 2018) for the measurement of the different OP severity levels, also considering specific gender related differences.

Primary Outcome Measures: Sensitivity and specificity, The primary outcome is to determine the sensitivity and specificity of the in vitro behavior (vitality, number, size, and differentiation) of PBMCs (peripheral blood mononuclear cells) in relation to different levels of bone metabolism alteration (ranging from osteopenia to fragility fractures)., January 2026
Secondary Outcome Measures: Correlation, The secondary outcomes include the evaluation and correlation of BMD via DXA T-score, vitality, number, size, and differentiation of PBMCs, T lymphocyte subpopulations, pro- and anti-inflammatory factors, platelet-related parameters, and the expression of biochemical markers of bone turnover in blood and serum samples from healthy individuals, as well as from osteopenic and osteoporotic patients (both fractured and non-fractured)., January 2026
Real-world Patient Reported Outcomes Among Patients Treated With Camzyos
NCT Number: NCT06551129
Acronym: COMPASS-HCM
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Obstructive Hypertrophic Cardiomyopathy
Interventions: DRUG: Mavacamten
Sponsor: Bristol-Myers Squibb
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 118
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-05-10
Completion Date: 2027-06-30
Locations: Analysis Group Inc., Boston, Massachusetts, 02199, United States

Summary:
This real-world study will assess changes in health status among participants with symptomatic obstructive hypertrophic cardiomyopathy who are treated with mavacamten in the real world.

Primary Outcome Measures: Participant Hypertrophic Cardiomyopathy symptoms as assessed by Hypertrophic Cardiomyopathy Symptom Questionnaire (HCMSQ v2,0 - 7-day recall version), Baseline and weeks 2, 4, 8, 12, 24, 30, 48, 60, 72, 84 and 96|Participant physical limitation, symptom stability, symptom frequency, symptom burden, self-efficacy, QoL, and social limitations as assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ-23), Baseline and weeks 2, 4, 8, 12, 24, 30, 48, 60, 72, 84 and 96|Participant mavacamten treatment status, Weeks 2, 4, 8, 12, 24, 30, 48, 60, 72, 84 and 96|Other pharmacological and surgical treatments for obstructive hypertrophic cardiomyopathy (HCM), Baseline and weeks 2, 4, 8, 12, 24, 30, 48, 60, 72, 84 and 96|Participant symptom severity as assessed by self-assessed New York Heart Association (SA-NYHA) functional class, Baseline and weeks 2, 4, 8, 12, 24, 30, 48, 60, 72, 84 and 96|Participant change in symptom severity as assessed by Patient Global Impression of Change (PGI-C), Weeks 2, 4, 8, 12, 24, 30, 48, 72, and 96|Participant septal reduction therapy, Baseline and weeks 12, 30, 48 and 96|Participant major injury or surgery since previous survey, Weeks 2, 4, 8, 12, 24, 30, 48, 60, 72, 84 and 96|Participant survey response on experience with CAMZYOS Risk Evaluation and Mitigation Strategy program (REMS) Program, Baseline and weeks 4, 12, 30, 48, 72 and 96|Participant medical history, Baseline
QuantifyHER: Quantitative Immunofluorescence and/or RT-qPCR for Measuring HER2 in HER2-low Metastatic Breast Cancer
NCT Number: NCT06551116
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: HER2-positive Metastatic Breast Cancer
Interventions: DIAGNOSTIC_TEST: CE-10-IVD
Sponsor: Angela DeMichele
Collaborators: Translational Breast Cancer Research Consortium|Danaher Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-01
Completion Date: 2029-09-01

Summary:
This study will assess whether a quantitative, HER2 assay can accurately and reliably discriminate between responders and non-responders among patients with HER2 IHCI+ metastatic breast cancer who are receiving T-Dxd.

Primary Outcome Measures: Real-World Objective Response Rate, Association between quantitative HER2 expression (as a continuous variable) and real-world objective response rate, from date of first dose of T-DXd to date of last dose of T-DXd for each. Up to 100 months
Secondary Outcome Measures: Real-World Progression Free Survival, Association between quantitative HER2 expression (as a continuous variable) and real world Progression Free Survival, from date of first dose of T-DXd to date of last dose of T-DXd for each.Up to 100 months|Real-World Progression Free Survival and Objective Response Rate by estrogen receptor expression, Association between HER2 expression by quantitative immunofluorescence and mRNA in HER2 IHC 1+ tumors and both rwORR and rwPFS, stratified by mRNA ER expression, from date of first dose of T-DXd to date of last dose of T-DXd for each. Up to 100 months|Threshold for HER2 QIF and/or mRNA levels, cut-off value for HER2 QIF, mRNA and the combination below which patients will not respond to T-DXd.", from date of first dose of T-DXd to date of last dose of T-DXd for each. Up to 100 months|Association between combined mRNA + QIF and real-world Objective Response Rate, Comparison, based on rwORR, of a linear combination of HER2 QIF and mRNA, versus either alone in ability to discriminate T-DXd responders from non- responders, from date of first dose of T-DXd to date of last dose of T-DXd for each. Up to 100 months
The Effect of Training Given to Patients With COPD in Line With Pender's Health Promotion Model
NCT Number: NCT06551103
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Chronic Obstructive Pulmonary Disease|Self Efficacy
Interventions: BEHAVIORAL: Intervention group trained in line with the Health Promotion Model
Sponsor: TC Erciyes University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 140
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2023-12-01
Completion Date: 2024-06-30
Locations: Sevda Korkut, Talas, Kayseri, 0(553) 310 49 51, Turkey

Summary:
This study was conducted as a randomized controlled experimental study. The study was conducted with patients hospitalized in the chest diseases intensive care unit of a state hospital. The study was terminated with the participation of 140 patients, 70 in each group. Data were collected with Descriptive Information Form and COPD Self-Efficacy Scale.

Primary Outcome Measures: Self-Efficacy, Self-efficacy was assessed with the COPD Self-Efficacy Scale. The 34-item COPD Self-Efficacy Scale has 5 sub-dimensions. The items in the scale are ranked from very safe (5 points) to not safe at all (1 point) and are Likert-type. In the evaluation of the scale, the higher the score obtained from the scale, the higher the competence level of the individual in managing respiratory difficulty., 3 months after the first test
Posterior Rectus Sheath Hiatal Augmentation in Paraesophageal Hernia Repair
NCT Number: NCT06551077
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Paraesophageal Hernia
Interventions: PROCEDURE: POSTERIOR RECTUS SHEATH HIATAL AUGMENTATION (PORSHA)
Sponsor: University of Chicago
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-05-15
Completion Date: 2029-05
Locations: The University of Chicago, Chicago, Illinois, 60637, United States

Summary:
This study will be a prospective observation study of the use of PoRSHA for repair in patients with challenging paraesophageal hernias.

One of the most challenging problems facing foregut surgeons is the large and complex paraesophageal hernia (PEH) repair in the older patient. The investigator has demonstrated good outcomes and durability with the initial use of a novel permanent autologous vascularized biologic fascial flap to reconstruct the diaphragmatic hiatus following standard hiatal hernia repair in selected patients. This technique is called a posterior rectus sheath flap hiatal augmentation or PoRSHA, which is performed to enhance the hiatal repair for large (type III and IV) and recurrent PEH. The investigator believes by using the patient's autologous vascularized and peritonealized fascia at the hiatal defect, PoRSHA could increase the strength and restore the hiatal complex properties in ways that synthetic mesh, or a primary repair cannot.

The hypothesis is that PoRSHA is a unique technique that has the potential to supplant current approaches to primary hiatal closure in select cases. By augmenting the hiatal closure with a vascularized fascial sheath, PoRSHA provides the tensile strength needed for the attenuated defects in large and complex PEHs.

Primary Outcome Measures: Number of participants with recurrence of hernia as seen radiographically at routine esophagram, At 6 months, 2 year and 5 years' time points
Secondary Outcome Measures: Number or participants with Symptom Relief, At 6 months, 2 year and 5 years' time points|Number of participants with use of anti-acid medications, At 6 months, 2 year and 5 years' time points|Number of participants with dysphagia symptoms, At 6 months, 2 year and 5 years' time points|Number of participants with abdominal wall deformities or symptoms, At 6 months, 2 year and 5 years' time points
Assessment of PK Similarity of FYB206 in Comparison With Keytruda in Resected Stage II or III Melanoma Patients
NCT Number: NCT06551064
Acronym: Dahlia
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Melanoma, Stage II|Melanoma Stage III
Interventions: BIOLOGICAL: pembrolizumab
Sponsor: Formycon AG
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 94
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-01
Completion Date: 2026-06-30
Locations: Formycon Investigative Site, Chisinau, Moldova, Republic of

Summary:
Melanoma is a kind of skin cancer that starts in the melanocytes. Melanocytes are cells that make the pigment that gives skin its colour. 'Resected' means the melanoma has been completely removed with surgery.

Pembrolizumab is an anti-cancer therapy that works with the immune system to fight cancer cells. Some cancer cells develop a way to hide from the body's immune system and, thus, allow the cancer cells to spread and grow. Pembrolizumab helps the immune system recognize and kill these cancer cells that want to hide.

Pembrolizumab is a biologic drug (produced by living organisms) available in the market under the brand name Keytruda. Keytruda is approved globally for the treatment of a variety of cancers and as an addon or after therapy to primary cancer treatment like surgery. This helps prevent the cancer from returning, improving overall survival.

FYB206 is a proposed biosimilar to Keytruda. A biosimilar is not identical but very similar to its original biologic. Biosimilars are expected to have a similar effect and safety to the original biologic. To learn what happens to a drug once it is in the body is called pharmacokinetics (PK). PK for biosimilar drugs is expected to remain similar to the original biologic. This study is to show that PK of FYB206 is similar to the reference product Keytruda for patients with completely resected Stage IIB/IIC or Stage III melanoma.

Primary Outcome Measures: AUCtau,sd at Cycle 1, Area under the concentration curve for one dosing interval (tau=21 days) after a single (initial) dose (AUCtau,sd) of FYB206 and Keytruda (Cycle 1), 21 days|AUCtau,sd at Cycle 6, Area under the concentration curve for one dosing interval (tau=21 days) at steady state (AUCtau,ss) of FYB206 and Keytruda (Cycle 6), 126 days
ADC-induced Neurotoxicity Treated with Duloxetine
NCT Number: NCT06551051
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Solid Tumour
Sponsor: Fudan University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 37
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-06
Completion Date: 2025-12-30

Summary:
RATIONALE: Duloxetine may lessen peripheral neuropathy caused by chemotherapy. It is not yet known whether duloxetine is effective in treating peripheral neuropathy caused by antibody-drug conjugate.

PURPOSE: This single arm phase II trial is studying duloxetine to see how well it works in treating peripheral neuropathy caused by antibody-drug conjugate in patients with cancer.

Primary Outcome Measures: FACT-GOG-NTx scale neurotoxicity score, FACT-GOG-NTx scale neurotoxicity score (duloxetine treatment day 0 and 36) (4-point decrease in neurotoxicity score).

FACT/GOG-NTx provides a targeted assessment of symptoms of peripheral neuropathy, including sensory, motor, and auditory problems and cold sensitivity., Day0 and Day36
Secondary Outcome Measures: Safety, Adverse events (AEs), including type, incidence, grading (based on NCI-CTCAE V5.0 criteria), severity, duration, and relevance to the study medications., 16 months|FACT-GOG-NTx scale neurotoxicity score, FACT/GOG-NTx provides a targeted assessment of symptoms of peripheral neuropathy, including sensory, motor, and auditory problems and cold sensitivity., 3 months|Numerical rating scale, A numeric pain rating scale is a single-item question that asks the patient to rate his or her pain on a scale of 0 to 10, using the anchors of "no pain" and "worse pain imaginable.", Day0 and Day36|QLQ-C30 Evaluation Scale, The scale consists of 30 questions measuring the patient's quality of life in terms of five functions (physical, daily living, cognitive, emotional and social), three symptoms (fatigue, pain, nausea and vomiting), and overall health, overall quality of life, and six other separate items (quality of sleep, appetite, diarrhoea, constipation, respiratory distress, and economic status)., Day0 and Day36|Neurotoxicity score assessed by CTCAE 5.0 scale, Grade 1: asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated

Grade 2: moderate; minimal, local or noninvasive intervention indicated; limiting age appropriate instrumental activities of daily living

Grade 3: severe or medically significant but not immediately life threatening; hospitalisation or prolongation of existing hospitalisation indicated; disabling; limiting self care activities of daily living

Grade 4: life threatening consequences; urgent intervention indicated, Day0 and Day36