pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Bioequivalence Study of Spironolactone Tablets in Healthy Subjects
NCT Number: NCT06579053
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Bioequivalence Study
Interventions: DRUG: Spironolactone Tablets (Test)|DRUG: Spironolactone Tablets (Reference)
Sponsor: SPH Sine Pharmaceutical Laboratories Co., Ltd.
Sex: ALL
Age: ADULT
Enrollment: 64
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: OTHER
Start Date: 2023-03-22
Completion Date: 2023-08-23
Locations: Shanghai Xuhui Central Hospital, Shanghai, Shanghai, 200031, China

Summary:
The goal of this clinical trial is to Evaluate the Bioequivalence of Spironolactone Tablets 100mg (by SPH Sine Pharmaceutical Laboratories Co.,Ltd) and ALDACTONE® tablets 100mg (by GD SEARLE LLC) in Chinese Healthy Adult Volunteers under Fasting and Fed Conditions. It will also learn about the safety of the two drugs.

Primary Outcome Measures: Cmax, Maximum Observed Concentration in Plasma, up to 24 hours after tablet intake|AUC 0-t, Area Under the Concentration-time Curve From Time Zero to Time of Last, up to 24 hours after tablet intake|AUC 0-∞, Area Under the Concentration-time Curve From Time Zero to Infinity, up to 24 hours after tablet intake
Prevalence and Prognostic Effects of Thyroid Abnormalities in Patients With Acute Coronary Syndrome.
NCT Number: NCT06579014
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Thyroid Dysfunction
Sponsor: Assiut University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 129
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-01
Completion Date: 2026-11

Summary:
Acute coronary syndrome (ACS) is an umbrella term used to describe a range of conditions associated with sudden, reduced blood flow to the heart. ACS includes conditions such as: Unstable Angina, Non-ST-Elevation Myocardial Infarction (NSTEMI) And ST-Elevation Myocardial Infarction (STEMI). The morbidity and mortality due to ACS are substantial-nearly half of all deaths due to coronary heart disease occur following an ACS .

Thyroid abnormalities, particularly hypothyroidism and hyperthyroidism, are relatively common in patients with ACS. Studies indicate that thyroid dysfunction can affect cardiovascular health, influencing the risk and prognosis of ACS. Reports suggest prevalence rates of Hypothyroidism 10-20% and Hyperthyroidism range from 1-5% in ACS patients .

Hypothyroidism is associated with elevated cholesterol levels, increased vascular stiffness, and heightened inflammation, can lead to reduced cardiac output and heart rate and increased incidence of heart failure and arrhythmias. all of which can exacerbate coronary artery disease and contributing to worse outcomes during ACS event. Hypothyroid patients often have a slower recovery and poorer response to standard ACS treatments, including thrombolytics and antiplatelet therapy.

Hyperthyroidism raises heart rate and contractility, leading to increased myocardial oxygen demand, which can worsen ischemia during ACS, Patients are more susceptible to arrhythmias, which can complicate ACS and lead to higher morbidity and mortality, Hyperthyroidism can cause vascular endothelial dysfunction, increasing the risk of thrombotic events during ACS and Patients may respond differently to standard ACS therapies, necessitating careful monitoring and potential adjustment of treatment strategies.

Patients with concurrent thyroid dysfunction often experience higher morbidity and mortality rates, So thyroid function should be routinely assessed in ACS patients, as early detection and management of thyroid abnormalities can improve clinical outcomes.

Primary Outcome Measures: Prevalence of thyroid abnormalities in patients with acute coronary syndrome ., 1/9/2024-1/10/2025
Effect of Nasal Spray Dexmedetomidine on Emergence Delirium Prevention in Total Hip Replacement
NCT Number: NCT06579001
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Delirium
Interventions: DRUG: Nasal spray dexmedetomidine
Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 264
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-08-19
Completion Date: 2025-04-08

Summary:
Emergence Delirium (ED) is a common postoperative complication refers to an acute brain dysfunction that occurs during the recovery from general anesthesia, which is mainly characterized by sudden attention and consciousness disorders. The occurrence of ED increases the risk of self-injury, wound dehiscence, accidental catheter dislocation, and postoperative delirium, and is also associated with postoperative cognitive deterioration and increased utilization of medical resources after discharge.

Primary Outcome Measures: emergency delirium, RASS\&CAM-ICU, delirium was judged according to whether there were positive features in the questionnaire, postoperative
Secondary Outcome Measures: Preoperative anxiety score, Perioperative anxiety scale，PAS-7, score range: 0-28, higher score means more anxiety, preoperative|Postoperative delirium, 3D-CAM,delirium was judged according to whether there were positive features in the questionnaire, postoperative 3 days|time to extubation, time to extubation, postoperative 3 days|PACU stay, length of PACU stay, postoperative 3 days|Hemodynamic changes, between drug administration and anesthesia introduction, introperative|PONV, the incidence of nausea and /or vomiting, postoperative 3 days|sleep quality, RCSQ, 0-100, higher score means higher sleep quality, postoperative 3 days|Pain score, NRS, 0-10, 0 means no pain, 10 means severe pain, postoperative 3 days
Use of Artificial Intelligence in the Symptomatic BReAst Clinic SEtting
NCT Number: NCT06578988
Status: ACTIVE_NOT_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Cancer, Breast
Interventions: PROCEDURE: Mammography Images
Sponsor: Royal Marsden NHS Foundation Trust
Collaborators: Imperial College Healthcare NHS Trust|St George's University Hospitals NHS Foundation Trust|Royal Surrey County Hospital NHS Foundation Trust
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 25000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-03-01
Completion Date: 2025-10-01
Locations: The Royal Marsden NHS Foundation Trust, Sutton, Surrey, SM2 5PT, United Kingdom

Summary:
Artificial Intelligence (AI) systems for the classification of mammography images have been developed and are beginning to be trialled and deployed in a breast cancer screening setting with encouraging results.

It is reasonable to think that these systems could be useful in the context of symptomatic breast clinic. However, these systems developed in the screening setting have unknown performance in the context of symptomatic breast clinic.

It is therefore important to test the performance of these systems in this alternative context.

This study will use retrospective data, from where it is possible to determine ground truth outcomes with greater confidence, accessing relatively large volumes of data with less patient burden when compared to prospective studies. This important cohort of patients has been less investigated to date, mainly because symptomatic data is typically more difficult to curate than screening data where key data is methodically prospectively collected.

The proposed work will be carried out in collaboration with a selected AI vendor and local clinical teams to define optimal use case scenarios for the symptomatic breast clinic.

Primary Outcome Measures: Performance of screening tool on symptomatic data, in terms of sensitivity and specificity., 18 months
Secondary Outcome Measures: Subgroup analysis based on ground-truth - Normal; Benign; Malignant., This is either normal, benign or malignant., 18 months
Efficacy, Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Ravulizumab in Chinese Adults Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH)
NCT Number: NCT06578949
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Paroxysmal Nocturnal Hemoglobinuria|PNH
Interventions: DRUG: Ravulizumab
Sponsor: Alexion Pharmaceuticals, Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 18
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-11-12
Completion Date: 2026-09-18
Locations: Research Site, Beijing, CN-100730, China|Research Site, Guangzhou, 510100, China|Research Site, Hangzhou, 310003, China|Research Site, Nantong, 226001, China|Research Site, Shanghai, 200040, China|Research Site, Tianjin, 300020, China|Research Site, Tianjin, 300052, China|Research Site, Wuhan, 430022, China

Summary:
The primary objective of this study is to evaluate the efficacy of ravulizumab in adult participants with PNH.

Primary Outcome Measures: Percentage Change in Lactate Dehydrogenase (LDH) From Baseline to Day 183 (Week 26), Baseline, Day 183 (Week 26)
Secondary Outcome Measures: Number of Participants Achieving LDH <1.5 × Upper Limit of Normal (ULN) at Day 183 (Week 26), Day 183 (Week 26)|Number of Participants Achieving Transfusion Avoidance (TA) Through Day 183 (Week 26), Day 183 (Week 26)|Number of Participants Experiencing Breakthrough Hemolysis Through Day 183 (Week 26), Day 183 (Week 26)|Change in Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-Fatigue) Score From Baseline to Day 183 (Week 26), Day 183 (Week 26)|Change in Hemoglobin (Hgb) From Baseline to Day 183 (Week 26), Baseline, Day 183 (Week 26)
The Effect of Abdominal Massage and Warm Application on Excretory Activity in Patients Undergoing Total Knee Replacement With Spinal Anesthesia
NCT Number: NCT06578936
Acronym: Abdominal
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Total Knee Replacement
Interventions: OTHER: abdominal massage andwarm application
Sponsor: Ayşe Demirtaş
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 84
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-08-05
Completion Date: 2025-06-30
Locations: Adana city hospital, Adana, Turkey|Mersin Univercity, Mersin, Turkey

Summary:
The aim of this study was to determine the effect of abdominal massage and warm application on the excretory activity (time of first bowel sounds, defecation time and the amount of laxative used until discharge) after total knee replacement surgery performed with spinal anesthesia.

Primary Outcome Measures: time for bowel sounds to return, The time of return of bowel sounds in the morning and evening will be assessed and recorded on the Excretory Activities Form., 1-3.days|time to defecate, the effect of abdominal massage and warm application on defecation time after total knee replacement, 1-3.day
Secondary Outcome Measures: risk of constipation, postoperative defecation status will be recorded on the excretory activity form and the risk of constipation will be assessed, 1-3.days|laxative use, The amount of medication used to facilitate defecation is assessed in the morning and evening and recorded on the Excretory Activities Form., 1-3.days
Immunonutrition and Psychosocial Factors in the Recovery of Patients After Gastrectomy: a Multidimensional Analysis
NCT Number: NCT06578858
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Gastric Cancer|Salutogenesis|Sense of Coherence
Interventions: BEHAVIORAL: Application of questionnaires
Sponsor: Universidade Federal de Pernambuco
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-11
Completion Date: 2024-12
Locations: Consultorios Guararapes, Jaboatão dos Guararapes, Pernambuco, 54330-230, Brazil

Summary:
To conduct this research, the following guiding question was formulated: "Can immunonutrition, combined with the assessment of SOC and resilience, provide a broad view of the physical and psychological results during the treatment and recovery process of patients undergoing gastric cancer surgery?". This led to the formulation of the following hypothesis: "Patients who received immunonutrition and who have higher levels of resilience and sense of coherence will tend to exhibit more favorable clinical and laboratory outcomes for recovery after gastric cancer surgery.

In order to answer the question and test the study hypothesis, the general objective consisted of:

To evaluate the association of clinical and laboratory outcomes with the sense of coherence and resilience of patients undergoing gastric cancer surgery who received immunonutrition.

In view of this general objective, the following specific objectives were formulated:

* To evaluate the levels of resilience and sense of coherence in patients undergoing gastric cancer surgery who received immunonutrition.
* Analyze the results of blood count and C-Reactive Protein (CRP) in patients who received immunonutrition after gastric cancer surgery.
* Identify the association between resilience levels, sense of coherence, blood count and CRP values with clinical outcomes, such as length of hospital stay and wound recovery, in patients undergoing gastric cancer surgery who used immunonutrition.

Primary Outcome Measures: Resilience Levels and Clinical Outcomes, 1) Separate outcome measures:

Levels of resilience Title: Measure of resilience level Description: Resilience will be measured using the Resilience Scale, with scores ranging from (1.00 - 2.99) = Low; (3.00 - 4.30) = Normal; (4.31 - 5.00) = High Unit of measurement: Score Measurement tool: Brief Resilience Scale (BRS)

Sense of coherence Title: Measure of sense of coherence Description: Sense of coherence will be assessed using the Sense of coherence Scale, with a median of 35 Unit of measurement: Median (35) Measurement tool: Sense of coherence scale questionnaire (SOC-13), Questionnaires to assess resilience and sense of coherence will be administered once, after gastric cancer removal surgery.
HappyMums App Study
NCT Number: NCT06578845
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Pregnancy|Antenatal Depression
Sponsor: King's College London
Collaborators: University of Milan|Ospedale San Raffaele|Catholic University of Croatia|University of Helsinki|Charite University, Berlin, Germany|SWPS University of Social Sciences and Humanities|Ab.Acus|University of Barcelona
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 1050
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-01
Completion Date: 2026-10-31

Summary:
The goal of this study is to investigate whether pregnant people at risk of, or currently suffering from antenatal depression, find it acceptable and feasible to use the 'HappyMums' mobile application during their pregnancy. This app will collect data relevant to their mental health passively and through active engagement from the user. After the study is complete, these data will be put together to determine if such data types could be used in future to help predict and identify antenatal depression, and aid better treatment decisions.

Primary Outcome Measures: Proportion of participants who continue to use mobile application from enrolment until they give birth., As this is a feasibility study, the primary outcome is whether participants feel able to continue to use the app throughout their pregnancy. Usage data of the app will be logged to ascertain if participants continue to engage with it throughout their pregnancy. 'Usage' of the application will be defined as submission of any questionnaire, logging of data, or interaction with any other activities or content on the application. This will be quantified as proportion of participants who use the app weekly from their enrolment on the app to the end of their pregnancy., From enrolment to end of pregnancy.
Secondary Outcome Measures: Usability of the mobile application - System Usability Scale, Questionnaire given to participants after pregnancy to ascertain if they find the app system usable., Administered once - to be completed from delivery to 2 months postpartum.|Acceptance of the mobile application - Unified Theory of Acceptance and Use of Technology Scale., Questionnaire given to participants after pregnancy to ascertain if they find the app system acceptable., Administered once - to be completed from delivery to 2 months postpartum.|Severity of antenatal depression - Edinburgh Postnatal Depression Scale, Antenatal depression will be measured using the EPDS, and will be available to complete on the application every 2 weeks., Every 2 weeks from enrolment to end of pregnancy.|Development of clinically significant depression - Mini International Neuropsychiatric Interview, The MINI will be administered to a validation sub-cohort to identify development of, or change in, symptoms of Major Depressive Disorder. This will be used to validate app-derived data types used to identify depression., Administered at enrolment and up to 2 months postpartum
Assessment of The Oral Health Status of Children With Chronic Kidney Disease
NCT Number: NCT06578832
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Chronic Kidney Diseases|Caries,Dental|Quality of Life|Saliva Altered|Periodontitis
Interventions: DIAGNOSTIC_TEST: physical and chemical methods|DIAGNOSTIC_TEST: biochemical methods|DIAGNOSTIC_TEST: biochemical tests|DIAGNOSTIC_TEST: Oral Health Habits|DIAGNOSTIC_TEST: Oral Findings|DIAGNOSTIC_TEST: Quality of Life Assessment
Sponsor: Marmara University
Sex: ALL
Age: CHILD, ADULT
Enrollment: 167
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-08-10
Completion Date: 2024-01-18
Locations: Marmara University Faculty of Dentistry, Istanbul, Maltepe, Turkey

Summary:
The aim of this study is to compare the oral health findings, salivary parameters and disease-related quality of life of children with different stages of Chronic Kidney Disease(CKD), those undergoing dialysis and transplantation, with healthy children, and to evaluate certain serum biomarkers in children with CKD.

Primary Outcome Measures: Oral Health Status, DMFT/dft indices, DI (Debris Index), CI (Calculus Index), and OHI-S (Simplified Oral Hygiene Index) scores,DDE Index (Developmental Defect of Enamel), MGI Index (Modified Gingival Index) and ICDAS-II. DMFT/dft index values, DI, CI, and OHI-S scores as numerical values. DDE, MGI Index and ICDAS-II are percentage of participants with these conditions. Prevalence of limited opacities, caries and gingival inflammation based on DDE, ICDAS II and MGI indices., baseline|Salivary Analysis, Salivary urea, calcium (Ca), potassium (K), phosphorus (P), total oxidant status (TOS) levels, and salivary flow rate. Concentration of urea, Ca, K, P, TOS in mg/dL or equivalent, and salivary flow rate in mL/min., baseline|Quality of Life (QoL), Quality of life scores on the KINDLR scale for both children with CKD and their parents, baseline
Secondary Outcome Measures: Correlation Between Oral Health Indices and Salivary Biomarkers, Correlation between DMFT/dft index, DI, CI, OHI-S scores, and salivary levels of urea, calcium (Ca), potassium (K), phosphorus (P), total oxidant status (TOS), and total antioxidant status (TAS). Pearson or Spearman correlation coefficient. DMFT/dft index, DI, CI, OHI-S scores for oral health assessment; biochemical analysis for salivary biomarker levels., baseline|Correlation Between Salivary Urea and Serum Urea Levels, Correlation between salivary urea levels and serum urea levels. Pearson or Spearman correlation coefficient. Biochemical analysis for salivary and serum urea levels., baseline|Correlation Between Salivary and Serum Calcium and Phosphorus Levels:, Correlation between salivary calcium and phosphorus levels and serum calcium and phosphorus levels. Pearson or Spearman correlation coefficient. Biochemical analysis for salivary and serum calcium and phosphorus levels., baseline
Tooth Loss Rate and Its Associated Factors: a Retrospective Cross-sectional Study With up to 50 Years of Follow-up.
NCT Number: NCT06578806
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Tooth Loss
Sponsor: Saint-Joseph University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 448
Study Design: Observational Model: |Time Perspective: p
Start Date: 1970-01
Completion Date: 2024-07

Summary:
This study will evaluate, in an adult population (n=448) previously diagnosed with gingivitis and/ or periodontitis, the tooth loss rate and its potential associated factors such as diabetes, smoking, bruxism, cardiovascular diseases, and also the effect of supportive periodontal therapy on these factors, with an up to 50 years of follow-up period.

Significant results of the present study will help in the future reduction of tooth loss among periodontally involved patients.

Primary Outcome Measures: Tooth loss rate, Number of teeth lost (initial - final) / number of years of follow-up, From 10 up to 50 years
Design and Delivery Preferences for Exercise Intervention in People With Spinal Cord Injury
NCT Number: NCT06578780
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Spinal Cord Injuries
Sponsor: University of Alabama at Birmingham
Collaborators: The Craig H. Neilsen Foundation
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-23
Completion Date: 2026-04-29
Locations: Wellness, Health and Research Facility (WHARF), Birmingham, Alabama, 35209, United States

Summary:
This research study aims to explore people's understanding of physical activity behavior and perceptions of what a physical activity program should include for supporting initiation and continuous participation. This study will enroll up to 30 adults (18 or over) with spinal cord injury. The study will use a discrete choice experiment (DCE) design that implements both quantitative (development of preference survey) and qualitative approaches (systematic review; test of preference survey).

Primary Outcome Measures: Demographics & clinical information, age, ethnicity, race, date of spinal cord injury onset, injury level, injury type, Baseline, during the first interview|Physical activity, Complete LTPAQ-SCI online survey (mins of physical activity per week), Baseline, during the first interview|Physical activity, Complete LTPAQ-SCI online survey (mins of physical activity per week), 3-month follow-up, before the second interview|Preference survey, Developed preference survey based on the first interview, 3-month follow-up, before the second interview
Decompression of Pudendal and Inferior Cluneal Nerves Using Robot-assisted Laparoscopy for Entrapment Neuralgias : the X-DECO Study
NCT Number: NCT06578767
Acronym: X-DECO
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Pudendal Neuralgia
Sponsor: UBOSGA
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08
Completion Date: 2025-07

Summary:
The objective of our study is to evaluate the efficacy of the laparoscopic robot-assited approach after 1 year of follow-up, on pain experience, and anxiety, depression, post-traumatic stress syndrome and quality of life.

Primary Outcome Measures: Evaluate the efficacy of the surgical technique on pain experience related to pudendal and inferior cluneal chronic entrapment neuralgias, using a composite criteria (Numeric pain scale, time seated, PGIC score), Numeric pain scale (0 "no pain" to 10 "maximal pain"), time seated (\> 30 min,\> 60min or unlimited) Patients' Global Impression of Change (PGIC) scale (1 "very hightly improved" to 7 "very hightly worsened") are combined to create a composite criteria (significant improvement to complete improvement), Pré-operatively, 2 days, 4 months, 1 year after surgery
Secondary Outcome Measures: Report all complications during the follow-up, Complications are evaluated with Clavien-Dindo classification (Grade I to V(death)), 2 days, 4 months, 1 year after surgery|Evaluate the effect of the surgical technique on anxiety, Anxiety is evaluated with STAI (State Trait Anxiety Inventory-form) (anxious personality since STAI score 51 for women, and score 61 for men), Pré-operatively, 2 days, 4 months, 1 year after surgery|Evaluate the effect of the surgical technique on depression, Depression is evaluated with Beck inventory (mild to moderate depression since score 10, moderate depression since score 19, severe depression since score 30), Pré-operatively, 2 days, 4 months, 1 year after surgery|Evaluate the effect of the surgical technique on post-traumatic stress syndrome, Post-traumatic stress syndrome is evaluated with PCL-5 (post-traumatic stress disorder checklist with a PTSD since score 38, Pré-operatively, 2 days, 4 months, 1 year after surgery|Evaluate the impact on quality of life, Quality of life is evaluated with SF-36 (36-item Short Form Health Survey), Pré-operatively, 2 days, 4 months, 1 year after surgery
Validation Test for Plasma Oxalate Level in a Biochemical Laboratory at the Galilee Medical Center
NCT Number: NCT06578754
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Hyperoxaluria
Interventions: OTHER: This is an non-interventional study
Sponsor: Western Galilee Hospital-Nahariya
Collaborators: Charite University, Berlin, Germany
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-01
Completion Date: 2026-02-01

Summary:
Given the need to perform an oxalate plasma test in Israel, and being a leading center in the field of hyperoxaluria in Israel, the investigators are interested in placing the test in the biochemical laboratory at our institution but require validation levels in comparison with leading laboratory in Europe.

Primary Outcome Measures: correlation of plasma oxalate between local and external laboratories, The plasma oxalate results from local and external laboratories will be compared by statistical analysis:

Comparison tests for paired samples - to examine the differences between two paired samples using the paired sample T test or the Wilcoxon signed rank test if the distribution of the differences is not normal. A 95% confidence interval will be calculated for the difference between the paired samples.

Correlation tests -Pearson's correlation coefficient test or alternatively Spearman's correlation coefficient test Bland-Altman plot and Scatter plot curves will be used to demonstrate the difference between the results.

A P value lower than 5% will be considered statistically significant. The investigators aim to to have non significant differences between the results of the laboratories in order to conclude that the results in the local laboratory are valid., 1 year
Local Methotrexate Injections for the Treatment of Nail Psoriasis
NCT Number: NCT06578728
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Nail Psoriasis
Interventions: DRUG: Methotrexate|DRUG: Triamcinolone Acetonide 10mg/mL|DRUG: Saline
Sponsor: Weill Medical College of Cornell University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 10
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-10-01
Completion Date: 2026-01
Locations: Israel Englander Department of Dermatology, New York, New York, 10021, United States

Summary:
The investigators hope to learn the efficacy of methotrexate injections for treatment of nail psoriasis.

Primary Outcome Measures: Change from baseline of nail dystrophy as measured by the Nail Psoriasis Severity Index, Mean change from baseline of the Nail Psoriasis Severity Index, which evaluates nail psoriasis symptoms with a score of 0-8 for each nail. Scores will be collected and analyzed per nail. For each nail measured by the study, patients can have a score between 0 and 8.

A score of 0 indicates no symptoms of nail psoriasis in the nail, and a score of 8 indicates nail psoriasis features are present in four quadrants of both the nail bed and nail matrix., Baseline (week 0), during intervention (weeks 1, 7, 13), post-intervention (weeks 17, 37)|Change from baseline of nail dystrophy as measured by the Physician-Assessed Global Improvement, Mean change from baseline in physician-assessed global improvement severity rating which rates each nail on a 5-point scale (rating 0 - 4) based on the presence of nail plate pitting, crumbling, onycholysis, oil-drop discoloration, or nail bed hyperkeratosis.

A score of 0 indicates none of the listed symptoms, while a score of 4 indicates severe symptoms. Scores will be collected and analyzed per nail., Baseline (week 0), during intervention (weeks 1, 7, 13), post-intervention (weeks 17, 37)
Secondary Outcome Measures: Treatment-Related Adverse Events, Number of participants with either treatment-related adverse events or treatment-related side effects in each treatment arm., 37 weeks
Emotional Freedom Technique (EFT) Applied to Postmenopausal Women on Sleep and Quality of Life
NCT Number: NCT06578715
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Menopause Related Conditions
Interventions: BEHAVIORAL: Emotional Freedom Technique
Sponsor: Ataturk University
Sex: FEMALE
Age: ADULT
Enrollment: 80
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-09-01
Completion Date: 2024-11-01

Summary:
The study will be conducted as a randomized controlled experimental study to determine the effects of the Emotional Freedom Technique (EFT) applied to women in menopause on sleep quality and quality of life.

It will be conducted with 80 women between the ages of 45-64, registered in a family health center in a city in the east of Turkey, who have been in menopause for at least one year and volunteer to participate in the study.

EFT will be applied to the women to be included in the experimental group in the study once a week, a total of four times in a month.

The "Participant Information Form", "Utian Quality of Life Scale" and "Pittsburgh Sleep Quality Scale" prepared by the researchers in line with the literature information will be used in the collection of research data.

Primary Outcome Measures: Quality of life levels during menopause, The difference between the Utian Quality of Life Scale pretest and posttest mean scores of women in both groups. Higher scores indicate increased quality of life., 1 month|Quality of sleep levels during menopause, The difference between the The difference between the Utian Quality of Life Scale pretest and posttest mean scores of women in both groups. The sleep quality of individuals whose total scale score is 5 points or less is considered "good"; the sleep quality of individuals whose score is above 5 points is considered "bad"., 1 month
Evaluation of Intermittent Triple Therapies in Real Life
NCT Number: NCT06578702
Acronym: ETRIVIE
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: HIV Infections
Sponsor: University Hospital, Strasbourg, France
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-02-21
Completion Date: 2025-02-21
Locations: Service Le Trait d'Union - CHU de Strasbourg - France, Strasbourg, 67091, France

Summary:
The strategy of intermittent triple therapy for people living with HIV was validated in France following the randomized clinical trial QUATUOR. There is little data in real life, as shown in the meta-analysis of Parienti JJ et al.

Currently this strategy is proposed by some teams in France, but is not recommended internationally.

The research hypothesis is that intermittent treatment is an effective and safe option in a therapeutic lightening strategy in people living with HIV People living with HIV adults followed in Strasbourg who have benefited from intermittent treatment The expected results will consist of an improvement in knowledge on the efficacy and tolerance of this therapeutic strategy.

Primary Outcome Measures: Evaluation of HIV viral load, 48 weeks after reduction of the HIV viral load
Factors and Consequences Associated With Diabetic Foot Problems Among Diabetic Patients in Jordan
NCT Number: NCT06578689
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Diabetic Foot
Interventions: BEHAVIORAL: Education
Sponsor: King Abdullah University Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-01-01
Completion Date: 2025-12-31
Locations: Jordan University of Science and Technology, Irbid, Jordan

Summary:
Purpose: To assess diabetic foot ulcers (DFU)-related risk factors and complications among diabetes mellitus (DM) patients in Northern Jordan. Also, to analyze the impact of educational intervention on their behavior.

Methods: The study consisted of two phases. Phase one was a prospective cross-sectional study of 200 DM patients, including 94 with a history of DFU, where demographic and clinical data were collected to assess diabetic foot-associated risk factors and complications. Phase two was a randomized clinical trial with 105 DM patients: 52 in the control group received standard care, while 53 in the intervention group received standard care supplemented with formal educational session and ongoing foot care education via mobile health by a clinical pharmacist. Foot care practices and medication adherence were evaluated at baseline and after 8 weeks of follow-up.

Primary Outcome Measures: Number of diabetic patients without diabetic foot ulcers, Patients diagnosed with DM and have no reported DFU, 8 weeks|Number of patients with diabetic foot ulcers, Patients diagnosed with DM and have been diagnosed with DFU, 8 weeks|Number of patients receiving diabetic foot care education, Patients diagnosed with DM and received diabetic foot care education, 8 weeks
Secondary Outcome Measures: Number of patients reporting good foot care practices, Patients diagnosed with DM and DFU, 8 weeks|Number of patients reporting Medication adherence, Patients diagnosed with DM and DFU, 8 weeks
Electrical Dry Needling Versus Iontophoresis in Treating Chronic Unilateral Knee Osteoarthritis
NCT Number: NCT06578663
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Osteoarthritis of Knee
Interventions: OTHER: conventional physical therapy|OTHER: Electrical Dry Needling|OTHER: Glucosamine sulfate iontophoresis
Sponsor: Horus University
Sex: ALL
Age: ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-06-01
Completion Date: 2025-06-01
Locations: out-patient clinic, faculty of physical therapy, Horus university, Damieta, Egypt

Summary:
The goal of this clinical trial is to compare the effects of electrical dry needling versus glucosamine sulfate iontophoresis on pain intensity level, functional ability, and knee range of motion in chronic unilateral knee osteoarthritis patients.

Primary Outcome Measures: Pain intensity level measurement, The visual analog scale (VAS) is a pain rating scale .A 10-cm line that represents a continuum between the two ends of the scale-"no pain" on the left end (0 cm) of the scale and the "worst pain" on the right end of the scale (10 cm), at baseline and after 6 weeks|Functional ability measurement, Knee Injury and Osteoarthritis Outcome (KOOS) Score.A 0-100 scale, with zero express extreme knee problems and 100 for no knee problems, as common in orthopedic scales., at baseline and after 6 weeks|Knee ROM measurement, A digital goniometer will be used to measure active knee ROM. The subject will be supine, flexing and extending their knee to the maximum. Bony landmarks will be identified for standardization and repeatability. The goniometer will be positioned over the lateral epicondyle of the femur, with the greater trochanter for reference. Measurements will be made three times, and the average value will be analyzed. Knee ROM measurements in patients with knee OA show high reliability., at baseline and after 6 weeks
Investigation of β-hydroxybutyrate Supplementation as Chemoprevention in Familial Adenomatous Polyposis
NCT Number: NCT06578637
Acronym: BHB-FAP
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: FAP|Familial Adenomatous Polyposis
Interventions: DIETARY_SUPPLEMENT: R-1,3-Butanediol (10MG-A)|DIETARY_SUPPLEMENT: R-1,3-Butanediol (20MG-A)|DIETARY_SUPPLEMENT: R-1,3-Butanediol (30MG-A)|DIETARY_SUPPLEMENT: R-1,3-Butanediol (10MG-B)|DIETARY_SUPPLEMENT: R-1,3-Butanediol (20MG-B)|DIETARY_SUPPLEMENT: Placebo
Sponsor: Abramson Cancer Center at Penn Medicine
Collaborators: The V Foundation for Cancer Research
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: SINGLE (PARTICIPANT)|Primary Purpose: PREVENTION
Start Date: 2024-10
Completion Date: 2027-10
Locations: Abramson Cancer Center of the University of Pennsylvania, Philadelphia, Pennsylvania, 19104, United States

Summary:
The aim of this study is to evaluate the potential of BHB supplementation as a novel strategy to impede the development and progression of intestinal adenomas in individuals with FAP, thus reducing the need for frequent upper endoscopies and colonoscopies, and potentially preventing the need for risk-reducing surgical intervention.

Primary Outcome Measures: Determine whether oral BHB supplementation is safe and tolerable in FAP, Assessment of FAP patient tolerance of BHB supplements through monitoring of side effects and/or intolerances and patient compliance. We will monitor the percentage of individuals who continue BHB supplementation for the duration of the study, as well as the compliance with taking the BHB supplement., Through study completion, which will be approximately 3 years
Secondary Outcome Measures: Measure whether oral BHB supplementations increases serum BHB levels in FAP, Measure fasting serum BHB levels before, during, and at the end of BHB supplementation to determine if BHB supplementation significantly increases serum BHB levels., Through study completion, which will be approximately 3 years|Change in transcription and protein expression in the intestinal mucosa and in intestinal polyps in FAP after oral BHB supplementation, Transcriptional profiling and subsequent validation with protein level determination will be performed in the intestinal mucosa and in intestinal polyps before and after BHB supplementation to determine if BHB supplementation is having measurable transcriptional and protein effects on the intestinal mucosa and on intestinal polyps., Through study completion, which will be approximately 3 years|Determine whether oral BHB supplementation in FAP reduces intestinal polyp burden, The polyp burden in the duodenum as well as in the lower GI tract (rectal cuff, rectum, rectal pouch) will be calculated through polyp counting and measurement on endoscopy before and after BHB supplementation to permit comparison of polyp burden before and after BHB supplementation., Through study completion, which will be approximately 3 years
Perioperative Smoking Cessation in Elderly Chinese Undergoing Spinal Fusion
NCT Number: NCT06578611
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Spinal Fusion
Interventions: COMBINATION_PRODUCT: Enhanced recovery after surgery
Sponsor: The Second Hospital of Shandong University
Sex: ALL
Age: OLDER_ADULT
Enrollment: 2000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09
Completion Date: 2027-12
Locations: The Second Hospital of Shandong University, Jinan, Shandong, 250033, China

Summary:
As China's society ages faster, the number of elderly patients undergoing spinal fusion surgery will gradually increase. Since elderly patients are at higher risk of postoperative complications than younger patients, minimizing complications after spinal fusion becomes a priority in postoperative rehabilitation. The purpose of this prospective cohort study is to develop an enhanced recovery after surgery program including individualized perioperative smoking cessation strategies in Chinese elderly undergoing spinal fusion.

Primary Outcome Measures: Incidence of any complications, Any major or minor complications occurs during this study will be reported., From the date of surgery until 6 months after surgery or the date of death from any cause, whichever come first.
Secondary Outcome Measures: Length of hospital stay, The period from admission to discharge will be reported., From the date of admission until the date of discharge or the date of death from any cause, whichever come first, assessed up to 6 months.|Prevalence of postoperative pain, Prevalence of postoperative pain will be assessed using the numeric rating scale., From the date of surgery until 6 months after surgery or the date of death from any cause, whichever come first.|Prevalence of pain-related disability, Pain-related disability will be assessed using Oswestry Disability Index (ODI)., From the date of surgery until 6 months after surgery or the date of death from any cause, whichever come first.|Level of quality of life, Quality of life after surgery will be evaluated using EuroQol-5-Dimensions-5-Level., From the date of surgery until 6 months after surgery or the date of death from any cause, whichever come first.
Comparison of Gastric Insufflation With the Classic Igel Laryngeal Mask and the New Igelplus Laryngeal Mask Using Gastric Ultrasound
NCT Number: NCT06578598
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Surgery|Anesthesia
Interventions: DEVICE: Igelplus
Sponsor: Luzerner Kantonsspital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: SINGLE (INVESTIGATOR)|Primary Purpose: OTHER
Start Date: 2024-10-01
Completion Date: 2025-12-01

Summary:
This study aims to compare the effectiveness and safety of two types of laryngeal masks- iGel and iGel Plus, used during elective surgeries. The focus is on evaluating differences in gastric insufflation and ventilation parameters between these two devices. Participants will be patients classified as ASA 1-2 with a BMI of less than 35, undergoing elective procedures.

The study is designed as a prospective, randomized, controlled trial with 200 subjects divided evenly between the two laryngeal mask groups. Key outcomes include gastric cross-sectional area (CSA) measurements before and after surgery, ventilation metrics such as leakage pressure and PEEP, and the incidence of postoperative complications like nausea and respiratory issues.

Primary Outcome Measures: Crosssectional are of stomach, Sonographic Measurement of gastric CSA, 5 minutes before anesthesia induction, during the surgery and 5 minutes after the surgery
Secondary Outcome Measures: Ventilator Parameters, Ventilator parameters like Inspiratory pressure (Pinsp), positive end expiratory pressure (PEEP) and leakage pressure in mmH2O, during the surgery|Insertions of laryngeal mask, How many atempts were needed to insert the laryngeal mask, during the induction of anesthesia (at the initiation of anesthesia)|postoperative complications, Nausea and vomiting, respiratory complications, after the surgery in recovery room
A Trial Investigating Lu AG09222 With Ubrogepant in Participants With Migraine
NCT Number: NCT06578585
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Migraine
Interventions: DRUG: Ubrogepant|DRUG: Lu AG09222|DRUG: Placebo
Sponsor: H. Lundbeck A/S
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, CARE_PROVIDER)|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2025-07-30

Summary:
The main goal of this trial is to learn more about the safety and tolerability of Lu AG09222 when taken together with ubrogepant. This includes looking for any new or worsening medical issues the participants have with the treatment. During the trial, participants with migraine will receive ubrogepant oral tablets and an injection of either Lu AG09222 or a placebo.

Primary Outcome Measures: Number of participants with treatment-emergent adverse events (TEAEs), Up to 92 Days
Secondary Outcome Measures: AUC0-infinity: Area under the plasma concentration curve of ubrogepant from zero to infinity, Predose on Day 1 to Day 12|Cmax: maximum observed plasma concentration of ubrogepant, Predose on Day 1 to Day 12|tmax: nominal time corresponding to the occurrence of Cmax, Predose on Day 1 to Day 12|t½: apparent elimination half-life of ubrogepant, Predose on Day 1 to Day 12|Oral Clearance (CL/F) of ubrogepant, Predose on Day 1 to Day 12|Apparent volume of distribution (VZ/F) of ubrogepant, Predose on Day 1 to Day 12|Number of participants with anti-drug antibodies for Lu AG09222, Up to 92 Days
Chemotherapy-free Regimen of Venetoclax, Azacitidine Plus Orebatinib (VAO Regimen) for Newly Diagnosed ph+ALL
NCT Number: NCT06578546
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Ph-Positive Acute Lymphoblastic Leukemia
Interventions: DRUG: Venetoclax|DRUG: Azacitidine|DRUG: Orebatinib
Sponsor: The First Affiliated Hospital of Soochow University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-02-01
Completion Date: 2026-02-01
Locations: The First Affiliated Hospital of Soochow University, Suzhou, Jiangsu, 215006, China

Summary:
The purpose of this study is to evaluate the efficacy and safety of Venetoclax, Azacitidine Plus Orebatinib in newly diagnosed Philadelphia chromosome-positive Acute Lymphoblastic Leukemia.

Primary Outcome Measures: complete molecular remission（CMR）, Proportion of patients achieving CMR at the end of 1 or 2 cycles, End of cycle 1 and 2 (each cycle is 28 days)
Secondary Outcome Measures: CR, Complete remission (CR) was defined as \< 5% bone marrow blasts in an aspirate with spicules and independent of transfusions., End of cycle 1 and 2 (each cycle is 28 days)|CRi, CR with incomplete hematologic recovery (CRi) was defined as \<5% bone marrow blasts, either ANC\<1×10\^9/L or platelets \< 100×10\^9/L, transfusion independence but with persistence of cytopenia., End of cycle 1 and 2 (each cycle is 28 days)|MRD-negative CR, Minimal residual disease (MRD)-negative CR was defined as a leukemic cell count below the sensitivity threshold of 1×10-4 (0.01%) bone marrow mononuclear cells (MNCs) by multiparameter flow cytometry., End of cycle 1 and 2 (each cycle is 28 days)|CCyR, Complete cytogenetic response (CCyR) was defined as lack of Ph in ≥ 20 bone marrow metaphases., End of cycle 1 and 2 (each cycle is 28 days)|MMR, Major molecular response (MMR) was defined as a BCR-ABL/ABL transcript ratio of 0.1% (international scale)., End of cycle 1 and 2 (each cycle is 28 days)|Number of adverse events, Adverse events are evaluated with CTCAE V5.0, End of cycle 1 and 2 (each cycle is 28 days)|RFS, Relapse-free survival (RFS) was the duration from the day of CR to leukemia relapse, death, or last follow-up, 1 year|OS, Overall survival (OS) was the time from enrollment to death for any reason., 1 year