pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Evaluating SARC-F, SARC-CalF, and Calf Circumference as Diagnostic Tools for Sarcopenia in Thai Older Adults: Results From a Nationwide Study
NCT Number: NCT06558617
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Sarcopenia|Diagnosis
Interventions: DIAGNOSTIC_TEST: SARC-F Questionnaire|DIAGNOSTIC_TEST: Calf Circumference Measurement|DIAGNOSTIC_TEST: SARC-CalF Questionnaire
Sponsor: Siriraj Hospital
Collaborators: National Research Council of Thailand
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 2543
Study Design: Observational Model: |Time Perspective: p
Start Date: 2021-03-01
Completion Date: 2022-08-31
Locations: Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkoknoi, Bangkok, 10700, Thailand

Summary:
As the elderly population grows, musculoskeletal disorders, including sarcopenia, have become a critical area of study due to their association with falls and fractures. Sarcopenia, characterized by decreased muscle mass, is prevalent among older adults and poses a significant risk for falls. This study aimed to assess the effectiveness of the SARC-F and SARC-CalF questionnaires, along with calf circumference measurements, in screening for sarcopenia among Thai community-dwelling older adults, following the Asian Working Group on Sarcopenia (AWGS) 2019 criteria.

Primary Outcome Measures: Appendicular skeletal muscle mass (ASM), To assess appendicular skeletal muscle mass (ASM), we used the Tanita RD-545, a dual-frequency bioelectrical impedance analysis (BIA) device (Tanita Corporation, Tokyo, Japan). Previous studies have demonstrated that this BIA method is reliable and comparable to dual-energy X-ray absorptiometry (DXA) for diagnosing sarcopenia in Thai elderly adults. The appendicular skeletal muscle mass index (ASMI) was calculated by dividing the ASM by the square of the height. According to the 2019 criteria of the AWGS, low muscle mass is defined as \<7.0 kg/m² for men and \<5.7 kg/m² for women., up to 4 weeks|Handgrip strength, Participants were asked to squeeze a digital Smedley spring hand dynamometer (Takei 5401 Digital Dynamometer; Takei, Tokyo, Japan) with maximum effort while standing with fully extended arms at their sides. The grip size was adjusted for each participant's hand size, and 2 or 3 trials were performed, with the highest output value recorded. Handgrip strengths \< 28 kg in males and \< 18 kg in females were classified as low muscle strength, per the AWGS 2019 criteria., up to 4 weeks|5-time sit-to-stand test (5TSTS), Participants were directed to sit upright on armless chairs with their backs supported firmly by the backrest. They were then instructed to stand up as quickly as possible for 5 repetitions with their arms crossed, trunk upright, and hips and knees fully extended. The time taken by each participant to complete the test from the initial sitting to the fifth sitting was recorded. The test is considered abnormal if it takes equal or more than 12 seconds to complete the task., up to 4 weeks
Association of Helicobacter Pylori Infection and Migraine
NCT Number: NCT06558578
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Migraine in Children
Interventions: DIAGNOSTIC_TEST: Helicobacter pylori antigen in stool
Sponsor: Sohag University
Sex: ALL
Age: CHILD
Enrollment: 50
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (CARE_PROVIDER)|Primary Purpose: DIAGNOSTIC
Start Date: 2024-08-01
Completion Date: 2025-08-30
Locations: Faculty of medicine sohag university, Sohag, Egypt

Summary:
The study aims to assess the relation between migraine and H pylori infection in children and adolescent.

Primary Outcome Measures: migraine in children and adolescent, assessment the association between migraine and H pylori infection in children and adolescent., Over 1 year
Efficacy of Stromal Vascular Fraction Versus Platelet Rich Plasma in Treatment of Androgenitic Alopecia
NCT Number: NCT06558565
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Androgenetic Alopecia
Interventions: PROCEDURE: stromal vascular fraction or platelet rich plasma
Sponsor: Kasr El Aini Hospital
Sex: MALE
Age: ADULT
Enrollment: 20
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-30
Completion Date: 2025-04-01
Locations: Kasr El Ainy hospital, Cairo, Egypt

Summary:
The goal of this randomized controlled clinical trial is to test the efficacy \& safety of stromal vascular fraction in treatment of AGA \& compare it to PRP The main questions it aims to answer are:

* efficacy \& safety of SVF for treatment of AGA patients
* comparing it to PRP in treatment of AGA Participants will receive a single session of SVF in one half of the scalp \& a single session of PRP in the other half.

Primary Outcome Measures: comparison of SVF versus PRP, to compare the mean difference in hair density,thickness, Norwood Hamilton scale, patient global assessment, patient satisfaction \& physician global assessment scores between SVF \& PRP., at 3 & 6 months after the sessions
Secondary Outcome Measures: Detecting efficacy of SVF in treatment of AGA, To detect provment in hair thickness \& diameter, at 3 & 6 months
Neuromodulation and Posterior Tibial Nerve , Randomized Controlled Trial
NCT Number: NCT06558552
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Pain, Chronic
Interventions: OTHER: transcutaneous pulsed radiofrequency|OTHER: extracorporeal shock wave therapy (ESWT)'
Sponsor: Halil Ibrahim Altun
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-01
Completion Date: 2024-09-30
Locations: Kanuni Sultan Süleyman Training and Research Hospital, Istanbul, 34000, Turkey

Summary:
Heel pain is an important clinical condition that impairs patients' quality of life and causes loss of workforce. Heel spurs are one of the most important causes of heel pain. Heel spur, often plantar fascia calcaneus It is seen at the site of attachment to the tuberosity and is plantar It develops secondary to microtrauma to the calcaneus following inflammation of the fascia , and over time, an organized bone protrusion called a spur forms in the same area . Plantar in patients with heel spurs It is often accompanied by fasciitis . Heel spurs are more common in women. It increases with increasing age due to mechanical trauma to the heel. Its incidence is not clearly known . In its etiology, age, gender, obesity, foot structure that disrupts biomechanics, rheumatological and metabolic diseases, and trauma come to the fore .

Nonsteroids in the treatment of heel spurs There are treatment options such as anti-inflammatory drugs (NSAIDs), other analgesics, exercise, splints and orthoses, shoe insoles and pads, corticosteroid injections into the spur area and extracorporeal shock wave therapy (ESWT). There are a limited number of studies in which pulse radiofrequency (PRF) and injection were applied to the posterior tibial nerve, which senses the region , and conventional or pulse radiofrequency was successfully applied to the lesion area .

ESWT is a non-invasive method. A shock wave is created together with sound and pressure waves. Changes at the cellular level with the shock wave include increased collagen production, increased blood flow in the applied area, acceleration of wound healing and cellular proliferation. In ESWT, radial and focal waves are applied depending on the tissue depth. patellar tendinopathy , plantar fasciitis , myositis It is an effective and reliable method that is frequently used in the treatment of ossificans , lateral epicondylitis , iliotibial band syndrome, many tendinopathies and heel spurs .

PRF is a newer neuromodulation method than conventional radiofrequency. It increases c-fos gene expression at the cellular level in neurons without causing destructive damage to the nerve , and A-delta and C fibers are affected. algogenic neuromediators decrease, endogenous opioids such as Dynorphin , Enkephalin and Endorphin increase, thus reducing pain.

Primary Outcome Measures: foot function index, four months
Uterocervical Angle Versus Cervical Length as a Predictor of Labor Induction in Term Singleton Pregnancy
NCT Number: NCT06558500
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Labor (Obstetrics)--Complications
Interventions: PROCEDURE: Uterocervical angle
Sponsor: Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital
Sex: FEMALE
Age: ADULT
Enrollment: 140
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-01
Completion Date: 2024-08-02
Locations: Etlik Zubeyde Hanım Women's Health Education Hospital, Ankara, 06000, Turkey

Summary:
Induction of labor is frequently performed in all obstetric clinics. Failed IOL has been defined in many different ways.Bishop scoring, which is a traditional and subjective method, is more frequently evaluated with cervical length, which has taken its place in preterm labor, and various ultrasonographic evaluations such as Uterocervical angle (UCA), Posterior cervical angle (PCA), cervical elastography, transvulvar ultrasonography, which have recently increased in popularity, have gained importance and led us to evaluate these parameters in our clinic. The relationship between the angles between the uterus and cervix and labor has been known for some time.

Primary Outcome Measures: The efficacy of uterocervical angle, The efficacy of uterocervical angle in predicting labor induction success in nulliparous patients at term., 2 days
The Internal Prospective Validation of the Cancer Admission Score (CAS) Prediction Model
NCT Number: NCT06558487
Acronym: ONCOMING
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Oncology
Interventions: OTHER: Cancer Admission Score Prediction Model
Sponsor: Erasmus Medical Center
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-10-01
Completion Date: 2025-02-01

Summary:
The goal of this single center prospective observational study is to determine the agreement between the cancer admission score (CAS) predicted disposition and the actual disposition in patients with an active cancer diagnosis visiting the emergency department (ED). The main question it aims to answer are: Is the performance of the CAS good enough to play a potential role in the ED care process. For each participant the CAS will be calculated and compared to the actual outcome.

Primary Outcome Measures: Cancer Admission Score, Cancer Admission Score (CAS) calculated after triage and after first blood results, ranging from 0 to 100%. The higher the score the greater the change of admission, Through study completion, an average of 6 months|Disposition, The outcome of a visit to the ED, being either admission or home, Through study completion, an average of 6 months|Agreement between the CAS and the actual disposition, Agreement between the CAS predicted outcome and the actual outcome, Through study completion, an average of 6 months
Secondary Outcome Measures: Agreement between expected disposition by nurse and actual disposition, Agreement between the nurse predicted outcome and the actual outcome, Through study completion, an average of 6 months|time-to-disposition, The average time between patient's arrival at the emergency department (ED) and the decision to disposition, Through study completion, an average of 6 months|time-to-leave, The average time between the decision to disposition and departure from the ED (either home or ward), Through study completion, an average of 6 months|ED Length of Stay, The total time spent in the ED by a patient during their visit, Through study completion, an average of 6 months
Other Outcome Measures: Sex, The sex of a patient, Through study completion, an average of 6 months|Age, The age of a patient, Through study completion, an average of 6 months|Type of Cancer, The type of cancer a patient has, Through study completion, an average of 6 months|Type of Treatment, Type of cancer treatment a patient receives, Through study completion, an average of 6 months|Main Complaint, Main complaint of ED visit, Through study completion, an average of 6 months|Physical parameters recorded during triage, Physical parameters that are recorded during triage and are used in the prediction model, Through study completion, an average of 6 months|First Blood results, The blood results that are recorded during triage and are used in the prediction model, Through study completion, an average of 6 months
Optimization of Percutaenous Coronary Intervention With Liberal Use of Post-dilatation
NCT Number: NCT06558474
Acronym: OPTIMIZE-PCI
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Coronary Artery Disease
Interventions: BEHAVIORAL: Liberal post-dilatation strategy during PCI
Sponsor: Cathreine BV
Collaborators: Medtronic
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 12000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-09-01
Completion Date: 2026-05-01
Locations: Catharina Hospital, Eindhoven, North- Brabant, 5623 EJ, Netherlands

Summary:
To achieve optimal long-term clinical results after percutaneous coronary intervention (PCI), adequate deployment of stents is essential. Thorough expansion of the stent and full apposition of stent struts against the vessel wall are determining factors for preventing stent thrombosis and restenosis for bare-metal as well as drug-eluting stents (DES). Standard coronary angiography is limited in assessing accurate vessel size and characterizing tissues and calcium load. Therefore, stent underexpansion frequently occurs after stent deployment.

Post-dilation is often performed to achieve optimal stent expansion and reduce stent malapposition of stent struts, aiming to reduce stent thrombosis and restenosis both short term as long term. However, there are limited studies that have explored the effect of post-dilatation for stent optimization on clinical outcomes. As a result of the restricted evidence, there is no consensus whether post-dilatation should be used routinely in clinical practice and the extent to which post-dilatation is being utilized remains unclear.

We therefore designed the OPTIMIZE PCI, a national registry-based quality improvement project to implement a liberal post-dilatation strategy in multiple PCI centers in the Netherlands. As part of the OPTIMIZE-PCI, a retrospective observational analysis will eventually be conducted to evaluate whether adopting this strategy has led to improved clinical outcomes after PCI in terms of MACE.

Primary Outcome Measures: Occurrence of target vessel revascularization (TVR), myocardial infarction (MI) and all-cause mortality, The primary composite end point of major adverse cardiac events is the occurrence of target vessel revascularization (TVR), myocardial infarction (MI) and all-cause mortality., 30 day
Secondary Outcome Measures: All cause mortality, all cause mortality, 30 days, 1 year|TVR, TVR, 30 days and 1 year|MI, MI, 30 day
Nebulised 3% Hypertonic Saline in Infants With Acute Bronchiolitis
NCT Number: NCT06558461
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: PHASE2|PHASE3
Conditions: Acute Bronchiolitis
Interventions: DRUG: 3% Sodium Chloride|OTHER: Standard care
Sponsor: Can Tho University of Medicine and Pharmacy
Sex: ALL
Age: CHILD
Enrollment: 140
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2022-06-01
Completion Date: 2024-05-28
Locations: Can Tho Children's Hospital, Can Tho, 900000, Vietnam

Summary:
This study aims to determine the efficacy of nebulising 3% hypertonic saline in improving clinical symptoms and reducing the length of hospital stay in infants with acute bronchiolitis.

Primary Outcome Measures: Improve clinical severity score after three days of treatment with nebulized 3% hypertonic saline., The clinical severity score is a validated, self-reported instrument assessing clinical severity over treatment. Possible scores range from 0 (mild) to 12 (severity)., three days
Secondary Outcome Measures: Shorten the mean length of hospital stays in infants with bronchiolitis after treatment with nebulized 3% hypertonic saline., The mean length of hospital stays is the days from admission to discharge of all participants., From admission to discharge, up to 14 days
Multimodal Prognostic System for Heart Failure: A Multi-Center Study
NCT Number: NCT06558448
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Heart Failure
Sponsor: Chongqing Medical University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08
Completion Date: 2024-12

Summary:
This study is a multicenter retrospective research aimed at developing a heart failure prognosis warning system based on multimodal clinical data to improve the diagnosis and treatment of heart failure.

This study aims to address the following main questions:

1. What are the clinical characteristics and current treatment status of heart failure patients?
2. What factors influence the onset of heart failure and the prognosis of patients?
3. How can real-world big data be utilized to construct an accurate heart failure prognosis assessment model?
4. How can this prognosis assessment model help improve the therapeutic effects and quality of life for heart failure patients?

Primary Outcome Measures: In-hospital mortality or other adverse outcomes, including readmission, in-hospital infection, respiratory failure, liver failure, and renal failure., The study focuses on evaluating the risk factors and predictors of in-hospital mortality and various adverse outcomes in heart failure patients, encompassing events such as readmission due to exacerbation of the condition, infections acquired during hospital stay, critical impairments in respiratory, liver, and kidney functions that may complicate the clinical course and impact patient prognosis., Evaluations will be conducted within 30, 60, or 90 days post-admission for heart failure patients to assess the impact of the condition and the effectiveness of treatment.
Validation of BRACS to European Portuguese
NCT Number: NCT06558435
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Deglutition Disorders|Swallowing Disorder|Dysphagia, Oropharyngeal
Interventions: OTHER: FEES
Sponsor: Centro Hospitalar de Entre o Douro e Vouga
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 16
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-03-01
Completion Date: 2023-05-01
Locations: Centro Hospitalar de Entre Douro e Vouga, Santa Maria Da Feira, 4520-211, Portugal

Summary:
The goal of this observational study is to translate and validate the fiberoptic endoscopic evaluation of swallowing scale "The Boston Residue and Clearance Scale - BRACS" to European Portuguese

Primary Outcome Measures: Reliable and validated European Portuguese version of the BRACS, Demonstrating the reliability and validity of the Boston Residue and Clearance Scale in diagnosing dysphagia during fiberoptic endoscopic assessment of swallowing examination. BRACS it's an 11-point ordinal residue classification scale that assesses 3 aspects: the amount and location of pharyngolaryngeal residues, the presence of spontaneous swallowing to clear it and the effectiveness of patient's swallowing., patients with neurological and/or mechanical oropharyngeal dysphagia evaluated FEES up to 3 months after the first symptomatology
Safer Still (Exploratory Project 3)
NCT Number: NCT06558409
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Suicide Prevention
Interventions: BEHAVIORAL: " Safer Still " Interactive Intervention|OTHER: Enhanced Usual Care (EUC):
Sponsor: Jeff Bridge
Collaborators: Ohio Chapter American Academy of Pediatrics
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: PREVENTION
Start Date: 2024-08
Completion Date: 2027-07-31
Locations: Nationwide Children's Hospital, Columbus, Ohio, 43205, United States

Summary:
Our long-term goal is to decrease suicide and suicidal behaviors in at-risk youth through preventative interventions. We propose to develop an interactive intervention ("Safer Still") to help promote safe storage of firearms during the critical period immediately following high-risk care transitions. The objective of this study is to develop and test the Safer Still intervention as an efficient adjunct to traditional care for adolescents aged 12-17 years who are discharged from psychiatric hospitals and living in households where firearms are stored unsafely.

Primary Outcome Measures: Household Lethal Means Survey (HLMS), The HLMS asks the parent to indicate whether there are any guns kept in or around the home, and if so to describe how the gun(s) and ammunition are stored. The LMS will be supplemented with three questions from the 2018 California Safety and Well-Being Survey. These three questions address reasons for firearm ownership, loaded handgun carrying in the past 30 days, and high-capacity magazine ownership. At follow-up, the study survey assesses whether and how firearm ownership and storage practices changed since baseline. Similar questions at baseline and follow-up are asked about lethal medications., Baseline, One month and Three months
Secondary Outcome Measures: Stages of Change Questionnaire (SOCQ), Readiness to change firearm and medication storage practices will be assessed using the Stages of Change Questionnaire (SOCQ), a psychometrically sound 12-item self-report measure. The questionnaire uses a 5-point Likert scale to measure the four stages of change: Pre-contemplation, Contemplation, Action, and Maintenance., Baseline, one month, and three months
Bladder Distension for Pain Relief in Nullliparous Patients Undergoing Diagnostic Office Hysteroscopy
NCT Number: NCT06558370
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Hysteroscopy
Interventions: OTHER: Empty bladder group|OTHER: Bladder distension group
Sponsor: Cairo University
Collaborators: Bedaya Hospital
Sex: FEMALE
Age: ADULT
Enrollment: 114
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-10-15
Completion Date: 2025-06-15
Locations: Obstetrics &Gynecology Department , Faculty of medicine ,Cairo university, Cairo, Egypt

Summary:
This study is conducted to assess whether the passive uterine straightening of the uterus by means of bladder filling is associated with less pain experienced by nulliparous women during office hysteroscopy.

Primary Outcome Measures: Intensity of pain, Measured using 100 mm visual analogue scale ( 0 = no pain and 100 = worst possible pain), Immediately after the procedure
Diagnostic Performance of 18-FDG PET-CT Scores for the Diagnosis of Polymyalgia Rheumatica
NCT Number: NCT06558357
Acronym: RHUMATEP
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Inflammatory Rheumatism|18-FDG|Positron-emission Tomography
Sponsor: University Hospital, Brest
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 210
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-01
Completion Date: 2024-12-31
Locations: Chu Brest, Brest, 29609, France

Summary:
Study of the diagnostic performance of 18-FDG PET scores in Polymyalgia rheumatica and comparaison with others inflammatories diseases.

Primary Outcome Measures: Diagnostic performance of 18-FDG PET scores for diagnostic of Polymyalgia rheumatica., Evaluation of the metabolism of mains joints compared to liver. Calculation of different scores described in literature., up to 9 months
Secondary Outcome Measures: Analysis of SUV and visual fixation of mains joints., Measure of SUV of mains joints and evaluation of the fixation compared to liver., up to 9 months|Diagnostic performance of 18-FDG PET scores for diagnostic of others inflammatory rheumatism., Evaluation of the precedent scores for diagnosis of others rheumatisms. Creation of others scores if some joints seem to be interesting., up to 9 months|Comparaison of scores with clinical, biological and radiological data., Search for correlation between scores and symptoms, blood test or CT/MRI exams., up to 9 months
A Study to Test Different Doses of BI 1569912 in People With Depression
NCT Number: NCT06558344
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Depressive Disorder, Major
Interventions: DRUG: BI 1569912|DRUG: Placebo matching BI 1569912
Sponsor: Boehringer Ingelheim
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 222
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-16
Completion Date: 2025-10-20

Summary:
This study is open to adults between 18 and 65 years of age with a type of depression called major depressive disorder. The purpose of the study is to find out whether a medicine called BI 1569912 helps people with depression.

Participants are put into 4 groups randomly, which means by chance. Three of the 4 groups take different doses of BI 1569912 and 1 group takes placebo. Placebo tablets looks like BI 1569912 but do not contain any medicine. Participants take the tablets once a day for 6 weeks.

Participants are in the study for about 2.5 months. During this time, they visit the study site at least 7 times. At the visits, doctors and their staff ask participants about their depression symptoms. At the end of the study, the results are compared between the groups to see whether the treatment works. The doctors also regularly check the general health of participants and take note of any unwanted effects.

Primary Outcome Measures: Change from baseline in MADRS total score at Week 6, The Montgomery-Åsberg Depression Rating Scale (MADRS) is a clinician reported interview guide designed to assess the severity of symptoms in depressive illness and to be sensitive to treatment effects.

The MADRS consists of 10 items:

1. reported sadness
2. apparent sadness
3. inner tension
4. reduced sleep
5. reduced appetite
6. concentration difficulties
7. lassitude
8. inability to feel
9. pessimistic thought
10. suicidal thoughts

Symptoms are rated on a 7-point Likert scale from 0 (no symptom) to 6 (severe symptom).

Definitions of severity are provided at 2-point intervals. The possible total score could range from 0 to 60 (from normal with absence of symptoms to severe depression)., at baseline and at Week 6
Quality of Postoperative Recovery (QoR-15T) in Patients Undergoing Video-Assisted Thoracoscopic Surgery (VATS)
NCT Number: NCT06558331
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Video-Assisted Thoracic Surgery
Interventions: OTHER: Preoperative Quality of Recovery-15 (QoR-15T)|OTHER: Postoperative 24th hour Quality of Recovery-15 (QoR-15T)
Sponsor: Başakşehir Çam & Sakura City Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-01
Completion Date: 2025-01-01
Locations: Başakşehir Çam Ve Sakura Şehir Hastanesi, Şişli, İstanbul, 34480, Turkey

Summary:
Video-assisted thoracoscopic surgery (VATS) is a minimally invasive technique that provides faster recovery after thoracic surgery. Techniques such as thoracic paravertebral block, Erector Spina Plane Expansion (ESP block) are accepted as loco-regional techniques for VATS. The quality of recovery after anesthesia (QoR) is an important information of the early health components of patients after surgery. QoR-15 offers a valid, reliable, sensitive and easy-to-use method for recovery after surgery. We aimed to investigate the relationship between QoR-15 score and postoperative pain temperature after Video-Assisted Thoracoscopic Surgery (VATS) ESP block and paravertebral spread.

Primary Outcome Measures: Effect of ESP block and paravertebral block on QoR-15 Quality of Recovery in VATS surgery, To demonstrate the effect of ESP block and paravertebral block on patient recovery at 24 hours using the Quality of Recovery-15 (QoR-15) scale in patients undergoing Video-Assisted Thoracoscopic Surgery (VATS), Complication,, 24 hour|Pain score with Numeric Rating Scale (NRS score),, The NRS is a one-dimensional scale using 11 numbers (0 to 10) to measure pain intensity. The patient is asked to choose the number that best reflects the pain intensity, with 0 = no pain and 10 = the worst (unbearable) pain., 1 day
IL-6, IL-12, IL-15 and IL-23 Expression Levels in Rheumatoid Arthritis Patients
NCT Number: NCT06558305
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Rheumatoid Arthritis
Interventions: OTHER: blood sample
Sponsor: Assiut University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09
Completion Date: 2025-04

Summary:
Rheumatoid Arthritis (RA) is a systemic autoimmune disease characterized by chronic inflammation and articular damage.

Continuous medical research has dramatically improved the outcomes for patients with RA. Traditional therapeutic approaches have relied on glucocorticoids, nonsteroidal anti-inflammatory drugs (NSAIDs) and disease modifying antirheumatic drugs (DMARDs) such as methotrexate, sulfasalazine or leflunomide. Glucocorticoids and NSAIDs interfere with the inflammatory cascades while DMARDs impede both the inflammatory and the destructive processes of RA.

These drugs, although efficient, are not specifically directed against inflammatory cells or cytokines and are associated with significant toxicity. The development of biologic DMARDs (bDMARDs), has been an important step forward. Their ability to neutralize specific cytokines or target distinct immune cells filled a gap in existing treatment options for RA. \[3\]. However, some patients still have only partial or no response to bDMARDs. More recently, a group of drugs has been developed that inhibit the janus kinase (JAK) family of intracellular tyrosine kinases, which transmit cytokine- mediated signals via the JAK-signal transducer and activator of transcription (STAT) pathway \[4\]. Baricitinib, with a selectivity to inhibit JAK1 and 2, has been FDA approved for RA in 2018 \[5\].

Many cytokines such IL-6, IL-12, IL-15, IL-23, (GM-CSF) and (IFNs) are associated with the pathogenesis of RA. These cytokines transduce signals via the JAK-STAT pathway.

Primary Outcome Measures: assess the effect of cDMARD and Baricitinib (JAKi) therapy on gene expressions of IL-6, IL-12, IL-15 and, IL-23 in patients with RA relative to the healthy controls., assess the effect of cDMARD and Baricitinib (JAKi) therapy on gene expressions of IL-6, IL-12, IL-15 and, IL-23 in patients with RA relative to the healthy controls., 6 months
The Effect of a Pre-Clinical Practice Simulation Using Virtual Reality Stress and Anxiety Levels
NCT Number: NCT06558292
Status: ENROLLING_BY_INVITATION
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Clinical Practice|Virtual Reality|Nursing Education|Nursing Students|Simulation
Interventions: OTHER: Virtual Reality Group
Sponsor: Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 82
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-08-14
Completion Date: 2024-12-01
Locations: University of Health Sciences Turkiye Gulhane Faculty of Nursing, Ankara, Turkey

Summary:
This study is designed as a randomized controlled trial to examine the effect of simulation practices using virtual reality headsets related to the operating room environment on nursing students' stress and anxiety levels before clinical practice.

Primary Outcome Measures: Change from anxiety and stress level in clinical practice, The simulation application of the operating room environment with virtual reality glasses to nursing students before clinical practice will affect the stress and anxiety levels of the students in the operating room. This status will evaluate with Spielberger's State and Trait Anxiety Inventory and Perceived Stress Scale for Nursing Students Spielberger's State and Trait Anxiety Inventory consists of a total of 40 items, 20 for each scale. The first form in the inventory includes statements about state anxiety, and the second form includes statements about trait anxiety High scores indicate high anxiety levels. Perceived Stress Scale for Nursing Students consists of 29 items and 6 sub-dimensions. Total score is 0-116 (sub-dimension total scores are: 0-12, 0-32, 0-20, 0-24, 0-12, 0-16). Higher scores indicate higher levels of stress. (Sheu et al. 2002)., After Simulation Using Virtual Reality in clinical pratice. An average of 1 year.
Secondary Outcome Measures: Change from confidence level in clinical practice, In this section, the degree of confidence level will increase or not decrease . This status will evaluate with Visual Analogue Scale (VAS). VAS is a horizontal line with a length of 10 cm. According to VAS, 0 is the lowest level and 10 is the highest level., After Simulation Using Virtual Reality in clinical pratice. An average of 1 year
The Safety and Efficacy of Coenzyme I for Injection in Promoting Hematopoietic Recovery of Patients After sUCBT
NCT Number: NCT06558253
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Hematopoietic Recovery
Interventions: DRUG: Coenzyme I for Injection
Sponsor: Anhui Provincial Hospital
Sex: ALL
Age: ADULT
Enrollment: 12
Study Design: Allocation: NA|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2026-06-01
Locations: The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital), Hefei, Anhui, 230036, China

Summary:
To assess the safety and efficacy of coenzyme I for injection in promoting hematopoietic recovery after single-unit unrelated cord blood transplantation in hematological malignancies.

Primary Outcome Measures: Adverse Event(AE), Number of treatment-related adverse events as assessed by CTCAE v5.0, From the date of initial treatment to 30 days after transplantation
Secondary Outcome Measures: Neutrophil engraftment time, The first day of absolute neutrophil count ≥ 0.5×10\^9/L for 3 consecutive days post transplantation., 42 days post transplantation|Cumulative incidence of neutrophil engraftment on day 16, Cumulative incidence of neutrophil engraftment on day 16 post transplantation., 16 days post transplantation|platelet engraftment time, The first day of platelet count ≥ 20×10\^9/L for 7 consecutive days without platelet transfusions for 7 consecutive days post transplantation., 180 days post transplantation|Cumulative incidence of platelet engraftment on day 60, Cumulative incidence of platelet engraftment on day 60 post transplantation., 60 days post transplantation|Cumulative incidence of primary graft failure on day 30, Cumulative incidence of primary graft failure on day 30 post transplantation., 30 days post transplantation|Cumulative incidence of grade II-IV and III-IV acute GVHD on day 100, Cumulative incidence of grade II-IV and III-IV acute GVHD on day 100 post transplantation., 100 days post transplantation|Cumulative incidence of transplant-related mortality on day 180, Cumulative incidence of transplant-related mortality on day 180 post transplantation., 180 days post transplantation|Cumulative incidence of relapse on day 180, Cumulative incidence of relapse on day 180 post transplantation., 180 days post transplantation|Probability of overall survival, Probability of overall survival on day 180 post transplantation., 180 days post transplantation|Probability of leukemia-free survival, Probability of leukemia-free survival on day 180 post transplantation., 180 days post transplantation|Probability of GVHD-free relapse-free survival, Probability of GVHD-free relapse-free survival on day 180 post transplantation., 180 days post transplantation
Study of ZG005 Combined With Bevacizumab Versus Sintilimab Combined With Bevacizumab in Advanced Hepatocellular Carcinoma
NCT Number: NCT06558227
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Hepatocellular Carcinoma
Interventions: BIOLOGICAL: ZG005 for Injection|BIOLOGICAL: Bevacizumab|BIOLOGICAL: Sintilimab|BIOLOGICAL: Bevacizumab
Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 90
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2026-10
Locations: West China Hospital of Sichuan University, Chengdu, Sichuan, China

Summary:
This study is a randomized, open-label, positive-controlled, multicenter phase II clinical trial. It evaluates the efficacy and safety of ZG005 combined with Bevacizumab compared to Sintilimab combined with Bevacizumab in first-line treatment for patients with advanced hepatocellular carcinoma.

Primary Outcome Measures: progression free survival，PFS, defined as the time from receiving treatment until disease progression or death from any cause, whichever happens first., through study completion, up to 2 year
OPTIMUS PRIME: Safety and Feasibility of OPTune GIO® Integrated With MRI-gUided Laser Ablation Surgery and Pembrolizumab for Recurrent GlIoblastoMa, A randomizEd Trial
NCT Number: NCT06558214
Acronym: OPTIMUS PRIME
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Recurrent Glioblastoma
Interventions: DRUG: Pembrolizumab|DEVICE: Optune GIO®|DEVICE: NeuroBlate®
Sponsor: University of Florida
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-10-30
Completion Date: 2029-10

Summary:
In this study we are evaluating the safety and feasibility of the triple combination (TTFields, MLA, pembrolizumab) in adult patients diagnosed with recurrent or progressive glioblastoma (GBM) WHO Grade IV, IDH wild type or recurrent or progressive astrocytoma WHO grade IV.

Primary Outcome Measures: Number of participants experiencing a DLT after receiving the triple combination (TTFields, MLA, pembrolizumab) in adult patients diagnosed with recurrent glioblastoma from both arms, Patients who receive the combinatorial regimen will get the ongoing safety assessment with DLT \</= 33% treated subjects, baseline up to 3 months|Percentage of participants treated with the triple combination (TTFields, MLA, pembrolizumab) in adult patients diagnosed with recurrent glioblastoma from both arms, Feasibility is defined as the ability to successfully deliver the combinatorial treatment of MLA, optune GIO® and pembrolizumab to at least 67% of enrolled subjects who undergo MLA., baseline up to 3 months
Combined Anabolic Therapy
NCT Number: NCT06558188
Acronym: CAT
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Osteoporosis, Postmenopausal|Osteoporosis
Interventions: DRUG: Romosozumab|DRUG: Teriparatide
Sponsor: Massachusetts General Hospital
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 46
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2025-04-01
Completion Date: 2028-01-01

Summary:
In this research study we want to learn more about the effect of two different FDA-approved medication regimens in the treatment of postmenopausal osteoporosis.

Primary Outcome Measures: Lumbar spine areal bone mineral density, Change in lumbar spine bone density between month 0 and month 12, Month 0 to 12
Reirradiation Dose Escalation in Thoracic Cancers
NCT Number: NCT06558175
Acronym: REPAIR
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Thoracic Cancer|Lung Cancer|Esophageal Cancer
Interventions: RADIATION: stereotactic body radiation therapy (SBRT)
Sponsor: Lawson Health Research Institute
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 48
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-10-30
Completion Date: 2027-01-29

Summary:
This is a study involving patients with recurrence, metastasis, or new primary malignancies in the thorax requiring radiation and who have previously received radiotherapy to the thorax, where re-irradiation is expected to exceed the dose constraints used for de novo treatments.

Currently, when this group of patients needs another set of radiotherapy, there is a dose limitation based on a percentage of the previous treatment's dose. However, this dose often limits the effectiveness of repeated treatment, with little scientific support for such. Therefore, this study aims to determine the maximally tolerated dose of reirradiation in the thorax, with dose escalation implemented by sequentially increasing the normal tissue recovery factors (i.e. repair factors) to the previously delivered dose.

Using a recovery factor equation associated with a 35% or lower rate of grade 3-5 treatment-related toxicity occurring within 1 year of treatment, accrual will start at level 1 (recovery factor = 10% at 6 months + 0.75% per month thereafter). Patients will be assigned to recovery factors using the TITE-CRM model. The model will use all available information from previously accrued patients to assign the highest dose with a predicted risk of grade 3-5 toxicity of 35% or less.

Primary Outcome Measures: Maximally tolerated dose (MTD), MTD of radiotherapy for thoracic tumors. The MTD is the dose of radiotherapy associated with a \<35% rate of grade 3-5 toxicity occurring within 1 year of treatment., occurring within 1 year of treatment
Secondary Outcome Measures: Time to progression, Progression of treated disease, 1-5 years|Time to distant metastases, Time to distant metastases, 1-5 years|Progression-Free Survival, Progression-Free Survival, 1-5 years|Overall survival, Overall survival, 1-5 years|Patient reported outcome, Functional Assessment of Cancer Therapy: Lung (FACT-L), Before treatment and at 3, 6, 9, 12, 18, 24, 36, 48, and 60 months|Quality of Life - EuroQol 5-dimension 5-level, EuroQol 5-dimension 5-level, Before treatment and at 3, 6, 9, 12, 18, 24, 36, 48, and 60 months
Deep Parasternal Intercostal Plane (DPIP) Block
NCT Number: NCT06558123
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Postoperative Pain
Interventions: PROCEDURE: block
Sponsor: Istinye University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-15
Completion Date: 2025-01
Locations: Istinye Üniversity, Istanbul, Merkez Mahallesi, 34250, Turkey

Summary:
In this study, we aimed to compare the effects of this block, which is routinely applied in our hospital but has not been studied in our hospital or in the literature before, on the pain in the first 24 hours after the operation, between the single-level and the two-level block.

Primary Outcome Measures: numeric rating scale, 24 hours pain, 4 month
Safety, Tolerability, and Pharmacokinetics of XXB750 in Healthy Participants
NCT Number: NCT06558097
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: XXB750 in Healthy Participants
Interventions: DRUG: XXB750|OTHER: Placebo
Sponsor: Novartis Pharmaceuticals
Sex: ALL
Age: ADULT
Enrollment: 77
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: OTHER
Start Date: 2020-07-29
Completion Date: 2023-03-31
Locations: Novartis Investigative Site, Cypress, California, 90630, United States

Summary:
This study was a randomized, participant and investigator-blinded, placebo-controlled, single-ascending dose study, consisting of 9 sequential dose cohorts (1 mg, 3 mg, 10 mg, 30 mg, 60 mg, 120 mg, 240 mg, 450 mg and 600 mg) and a Japanese ethnic sensitivity cohort (240 mg dose)

Primary Outcome Measures: Number of participants with Adverse Events, To evaluate the safety and tolerability of single ascending SC doses of XXB750 in healthy participants.

Adverse events may include abnormal vital signs, safety laboratory tests, physical exam tests and ECG parameters that include clinical signs or symptoms, are considered clinically significant or require therapy., Up to 121 days
Secondary Outcome Measures: Pharmacokinetics parameters: Tmax, To evaluate the pharmacokinetics: Time to maximum concentation (Tmax) of XXB750 in healthy participants following a single SC dose of XXB750., Up to 91 days|Pharmacokinetics parameters: Cmax, To evaluate the pharmacokinetics: Peak plasma concentration (Cmax) of XXB750 in healthy participants following a single SC dose of XXB750., Up to 91 days|Pharmacokinetics parameters: AUClast, To evaluate the pharmacokinetics: Area under the plasma concentration curve (AUClast) of XXB750 in healthy participants following a single SC dose of XXB750., Up to 91 days|Pharmacokinetics parameters: AUCinf, To evaluate the pharmacokinetics: Area under the curve (AUCinf) of XXB750 in healthy participants following a single SC dose of XXB750., Up to 91 days|Pharmacokinetics parameters: T1/2, To evaluate the pharmacokinetics: Half-life (T1/2) of XXB750 in healthy participants following a single SC dose of XXB750., Up to 91 days|Pharmacokinetics parameters: Vz/F, To evaluate the pharmacokinetics: Vd/F of XXB750 in healthy participants following a single SC dose of XXB750., Up to 91 days|Pharmacokinetics parameters: CL/F, To evaluate the pharmacokinetics: Apparent clearance (CL/F) of XXB750 in healthy participants following a single SC dose of XXB750., Up to 91 days
Real-World Clinical Outcomes and Toxicity in Metastatic Breast Cancer Patients Treated With First or Second Line CDK 4/6 Inhibitors and Endocrine Therapy
NCT Number: NCT06558084
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Toxicity, Drug|Progression, Disease
Interventions: DRUG: CDK4/6 Inhibitor
Sponsor: Ain Shams University
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 64
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-07-06
Completion Date: 2024-08-10
Locations: Ainshams University, Cairo, Egypt

Summary:
To assess CDK4/6i toxicity and effect on PFS in the Egyptian population

Primary Outcome Measures: Adverse effect, assess the toxicity profile, 2 years
Secondary Outcome Measures: PFS, PFS in patient receiving CDK4/6i in Egypt, 2 years
Bioequivalence Study of Rivaroxaban 10 mg Film-coated Tablets
NCT Number: NCT06558058
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Healthy
Interventions: DRUG: Rivaroxaban 10 mg film-coated tablet|DRUG: Xarelto 10 mg film-coated tablet
Sponsor: Dexa Medica Group
Collaborators: PT Equilab International
Sex: ALL
Age: ADULT
Enrollment: 28
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: OTHER
Start Date: 2023-06-08
Completion Date: 2023-08-29
Locations: PT Equilab International, Jakarta, 12430, Indonesia

Summary:
This study was an open-label, randomized, single-dose, two-period, two-sequence, two-way crossover study under fasting conditions which included 28 healthy adult male and female subjects. The objective of this study was to compare whether the bioavailability of PT Dexa Medica's formulation of rivaroxaban 10 mg film-coated tablet is equivalent to that of the comparator drug (Xarelto® 10 mg Film-Coated Tablet, manufactured by Bayer AG, Germany, imported by PT Bayer Indonesia, Indonesia) when administered under fasting condition in healthy subjects.

Primary Outcome Measures: AUC(0-t), Area under the plasma concentration-time curve to the last observer quantifiable concentration at time t, 36 hours|Cmax, Maximum plasma concentration, 36 hours
Secondary Outcome Measures: AUC(0-inf), Area under the plasma concentration-time curve extrapolated to infinitive time, 36 hours|T1/2, Plasma half-life, 36 hours|Tmax, Time taken to reach maximum observed plasma concentration, 36 hours