pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Combination of Orelabrutinib and Obinutuzumab in Untreated Marginal Zone Lymphomas
NCT Number: NCT06513234
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Marginal Zone Lymphoma
Interventions: DRUG: Orelabrutinib and obinutuzumab
Sponsor: Institute of Hematology & Blood Diseases Hospital, China
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 45
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-11
Completion Date: 2029-06-21
Locations: China Institute of Hematology and Blood Diseases Hospital ,Chinese Academy of Medical Sciences, Tianjin, 300020, China

Summary:
This is a prospective single arm phase II study, and the purpose of this study is to evaluate the safety and efficacy of orelabrutinib combined with obinutuzumab a in untreated marginal zone lymphoma. It is planned to recruit 45 patients. The primary endpoint is the complete remission rate at 12 months.

Primary Outcome Measures: the complete response rate, CRR is defined as the proportion of patients with a response of CR, At 12 months.
Secondary Outcome Measures: CRR, CRR is defined as the proportion of patients with a best response of CR, At the end of induction therapy(6cycles). 28days/cycle|ORR, The ORR is defined as the proportion of patients with a response of CR, At 12 months.|BOR, The BOR is defined as the proportion of patients with a best response of CR or PR, At 12 months.|2 years progression-free survival, Progression free survival (PFS) is defined as the time from registration to the first occurrence of progression or relapse as assessed by the investigator, or death from any cause. PFS for patients without disease progression, relapse, or death will be censored at the time of the last tumor assessment., From date of signing the informed consent until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years|2 years overall survival, Overall survival is defined as the period from the induction registration to death from any cause. Patients who have not died until the time of the analysis will be censored at their last contact date., From date of signing the informed consent until the date of death from any cause, whichever came first, assessed up to 2 years]|TTR, TTR is defined as the time from registration to the first response., Up to 2 years|Duration of Response (DOR), Duration of response as defined as the period from the first response (at least PR) to treatment until evidence of disease progression, relapse or death of any cause. Patients alive without progression and relapse will be censored at the latest tumor assessment date or the stopping date., Up to 2 years|The occurrence of adverse events and serious adverse events, Adverse events will be graded by the investigator according to the NCI-CTCAE Version 5., One month after discontinuation of treatment
A Prospective Study of MSS-type Metastatic Colorectal Cancer Receiving Multiple Lines of Standard Chemotherapy, Bevacizumab Combined With Adebrelimab
NCT Number: NCT06513221
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Metastatic Colorectal Cancer
Interventions: DRUG: Chemotherapy, Bevacizumab, Adebrelimab
Sponsor: Fudan University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-25
Completion Date: 2027-04-12

Summary:
This study is a prospective, multi-arm, phase II clinical trial that uses transcriptome profiling to guide the evaluation of the efficacy of multiple lines of standard chemotherapy and bevacizumab combined with adebrelimab in patients with MSS-type metastatic colorectal cancer, aiming to expand the immunotherapy cohort while accurately narrowing the population of MSS-type colorectal cancer that benefits from immunity. This study includes a screening period, a treatment period, and a follow-up period.

Primary Outcome Measures: Objective Response Rate, The percentage of people in a study or treatment group who have a partial response or complete response to the treatment within a certain period of time according to RECIST 1.1., 2 years
Secondary Outcome Measures: Disease Control Rate, The percentage of patients with advanced or metastatic cancer who have achieved complete response, partial response and stable disease to a therapeutic intervention in clinical trials of anticancer agents according to RECIST 1.1., 2 years|Progression Free Survival, The length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse. In a clinical trial, measuring the progression-free survival is one way to see how well a new treatment works according to the results of RECIST 1.1., 2 years|Overall Survical, The length of time from either the date of diagnosis or the start of treatment for a disease, such as cancer, that patients diagnosed with the disease are still alive. In a clinical trial, measuring the overall survival is one way to see how well a new treatment works., 2 years|QoL, QoL will be eveluated based on EORTC QLQ-C30, 2 years|Incidence of Treatment-related Adverse Events (Safety ), This will be evaluated based on NCI CTCAE, including the number of participants with Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment., 2 years
Ketorolac Effects on Post-operative Pain and Lumbar Fusion
NCT Number: NCT06513208
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Spinal Fusion
Interventions: DRUG: Ketorolac Tromethamine|DRUG: Placebo
Sponsor: University of Maryland St. Joseph Medical Center
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 140
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2026-08-01

Summary:
A double blind prospective randomized trial of IV Ketorolac vs. placebo in management of patients undergoing lumbar one or two level spinal fusions.

Primary objective

- To demonstrate Ketorolac results in decreased postoperative opioid use following posterior spinal fusions during the first 48 hours.

Secondary objectives

* To demonstrate that the use of Ketorolac does not decrease spinal fusion in one or two level instrumented spinal fusions.
* To demonstrate the use of Ketorolac decreases the average length of stay following spinal fusions.

Primary Outcome Measures: Ketorolac results in decreased post-op opioid use when administered in the first 48 hours, measured by calculating the total amount of MME utilized during the patient's inpatient stay and comparing the control and experimental groups., 6 months
Secondary Outcome Measures: Ketorolac use does not decrease spinal fusion rates in one to two level fusion. Fusion failure is measured by > than 2 degrees motion on standardized flexion/extension x-rays when compared to pre-op imaging analyzed by spinecamp software at the 6 months., 6 months'|Ketorolac use decreases average length of hospital stay. Length of stay for both the control group and the experimental group will be counted, and a statistical average for each group will be calculated and compared., 6 months
Do Wound Protectors Reduce Contamination in Total Shoulder Arthroplasty?
NCT Number: NCT06513182
Status: ENROLLING_BY_INVITATION
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cutibacterium Acnes
Interventions: OTHER: No Alexis orthopaedic protector|DEVICE: Alexis orthopaedic protector
Sponsor: University of Utah
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: OTHER
Start Date: 2024-06-21
Completion Date: 2029-06
Locations: University of Utah Orthopedics, Salt Lake City, Utah, 84108, United States

Summary:
Prosthetic joint infection is a devastating complication of shoulder arthroplasty. A relatively novel method of preventing PJI has been with the use of a wound protection device. There is minimal investigative research on the use of a wound protector in shoulder arthroplasty, specifically with an ability to decrease wound contamination. The investigators primary purpose of the proposed study is to determine if the use of a wound protector deceases the deep wound colonization of bacteria in primary shoulder arthroplasty. A secondary purpose is to evaluate if the wound protector decreases soft tissue trauma during total shoulder arthroplasty.

Primary Outcome Measures: Positive C acnes culture, The primary outcome of the study will be percent of positive C acnes culture results., 2-weeks
Lower Extremity Elevation to Minimize Hemodynamic Instability During Induction of General Anesthesia
NCT Number: NCT06513169
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Post Induction Hypotension
Interventions: PROCEDURE: Group 1: LEE
Sponsor: The University of Texas Health Science Center, Houston
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-07-15
Completion Date: 2024-12-31
Locations: The University of Texas Health Science Center at Houston, Houston, Texas, 77030, United States

Summary:
The purpose of this study is to determine if lower extremity elevation (LEE) will reduce the incidence of postinduction hypotension, to compare the utilization of vasoactive medications after induction in patients with LEE and patients without LEE and to determine if LEE will increase measured cardiac output

Primary Outcome Measures: Number of participants that demonstrate hypotension, Hypotension is defined as the reduction in mean arterial pressure by 20% or greater comparing the blood pressure measured before induction of anesthesia, From start of anesthesia upto institution of positive pressure ventilation (about 5 minutes)
Secondary Outcome Measures: Number of participants that demonstrate Nadir blood pressure, Nadir blood pressure is the lowest value of blood pressure (BP) that can occur, From start of anesthesia upto institution of positive pressure ventilation (about 5 minutes)|Change in heart rate, From start of anesthesia upto institution of positive pressure ventilation (about 5 minutes)|Number of participants that need rescue vasoactive agents, From start of anesthesia upto institution of positive pressure ventilation (about 5 minutes)|Accumulated dose of rescue vasoactive agents, End of study (within 15 minutes of baseline)|Change in non-invasive cardiac output, From start of anesthesia upto institution of positive pressure ventilation (about 5 minutes)
Metaverse Surgical Simulation Platform
NCT Number: NCT06513143
Acronym: Metaverse
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Virtual Reality
Interventions: OTHER: CT images into virtual 3D model demonstration
Sponsor: National Taiwan University Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 70
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-01-01
Completion Date: 2024-12-31
Locations: Department of Surgery, National Taiwain University Hospital, Taipei, 100, Taiwan

Summary:
This project aims to combine virtual reality (VR) technologies to construct a metaverse simulation lung surgery platform, which can not only be used as equipment for training novices, but also as a simulated rehearsal before actual surgery, to improve the safety and smoothness of difficult surgeries.

Primary Outcome Measures: questionnaires, To evaluate the satisfaction levels of students or operators, Through study completion, an average of 1 year.
LIving BEtteR With asThma studY:: A Multimodal Intervention to Address Multimorbidity in Difficult Asthma
NCT Number: NCT06513117
Acronym: LIBERTY
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Asthma|Multi Morbidity
Interventions: BEHAVIORAL: Behaviour change|BEHAVIORAL: Dietary support|BEHAVIORAL: Breathing pattern retraining|BEHAVIORAL: Exercise training
Sponsor: University of Southampton
Collaborators: University Hospital Southampton NHS Foundation Trust
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-10
Completion Date: 2028-04

Summary:
Multimorbidity is a significant issue for many patients with difficult asthma. With patients, we have co-designed a multimodal intervention comprising prescribed exercise, dietary support, breathing pattern retraining and behaviour change to target multimorbidity in difficult asthma

Primary Outcome Measures: Improvement in Asthma Control Questionnaire score, Primary feasibility outcome is feasibility and acceptability to patients. Primary clinical endpoint outcome measure will be a minimal clinically significant improvement in ACQ 6 score (\>0.5). Score scale is from 0-6, with \< 1.5 demonstrating good asthma symptom control., pre and post intervention, at 12 month follow up
Secondary Outcome Measures: Improvement in exercise capacity, QoL scores, exacerbation frequency, Increase in exercise capacity as assessed through oxygen uptake of \> 2ml/kg/min at anaerobic threshold (AT) on maximal, symptom limited, incremental shuttle walk test., pre and post intervention, at 12 month follow up|Asthma Quality of Life Questionnaire (AQLQ), 32 questions scored on Likert scale 1-7. Score is mean of 32 answers, range 1-7 (higher =better quality of life, pre and post intervention, at 12 month follow up|Exacerbation frequency, number of asthma exacerbations requiring oral corticosteroid treatment, pre and post intervention, at 12 month follow up
A Research Study Looking Into the Effect of NNC0519-0130 on Blood Levels of a Birth Control Pill and Emptying of the Stomach in Women After Menopause
NCT Number: NCT06513104
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Healthy Volunteers
Interventions: DRUG: NNC0519-0130|DRUG: Levonorgestrel + Ethinylestradiol|DRUG: Paracetamol
Sponsor: Novo Nordisk A/S
Sex: FEMALE
Age: CHILD, ADULT
Enrollment: 37
Study Design: Allocation: NA|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-18
Completion Date: 2025-05-27
Locations: Parexel International GmbH, Berlin, 14050, Germany|Parexel International GmbH, Berlin, 14050, Germany

Summary:
The purpose of the study is to investigate if NNC0519-0130 affects the blood levels of a birth control pill that contains the two hormones ethinylestradiol and levonorgestrel. The study will also look into if NNC0519-0130 affects how fast stomach is emptied. Participants will get the new study medicine NNC0519-0130 and will also get birth control pills and paracetamol. The study will last for about 39 weeks.

Primary Outcome Measures: Area under the ethinylestradiol plasma concentration time curve during a dosing interval at steady state, Measured in hours picograms per milliliter (h\*pg/mL)., Day 8|Area under the ethinylestradiol plasma concentration time curve during a dosing interval at steady state, Measured in h\*pg/mL., Day 216|Area under the levonorgestrel plasma concentration time curve during a dosing interval at steady state, Measured in h\*pg/mL., Day 8|Area under the levonorgestrel plasma concentration time curveduring a dosing interval at steady state, Measured in h\*pg/mL., Day 216
Secondary Outcome Measures: Maximum ethinylestradiol plasma concentration at steady state, Measured in picograms per milliliter (pg/mL)., Day 8 and Day 216|Maximum levonorgestrel plasma concentration at steady state, Measured in pg/mL., Day 8 and Day 216|Area under the paracetamol concentration-time curve for 0-300 minutes following a standardised meal, Measured in hours micrograms per milliliter (h\*μg/mL)., Day 1 and Day 209|Area under the paracetamol concentration-time curve for 0-60 minutes following a standardised meal, Measured in h\*μg/mL., Day 1 and Day 209|Maximum paracetamol plasma concentration following a standardised meal, Measured in micrograms per milliliter (μg/mL)., Day 1 and Day 209
US National TOP Registry
NCT Number: NCT06513091
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Lung Transplant
Interventions: DEVICE: OCS Lung
Sponsor: TransMedics
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 10000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-11
Completion Date: 2039-11

Summary:
The objective of this Registry is to collect short and long-term post-transplant clinical outcome data of all donor lungs preserved and assessed on the OCS Lung System and to document the performance of the OCS device in the real-world setting after FDA approval in the US.

Primary Outcome Measures: One-year patient and graft survival, Recipients' one-year patient and graft survival rates, 1-year post-transplant
Different Types of Cupping Therapy and Ankle Range of Motion
NCT Number: NCT06513078
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Healthy
Interventions: OTHER: Static cupping|OTHER: Static sham cupping|OTHER: Dynamic cupping|OTHER: Dynamic sham cupping
Sponsor: Northern Michigan University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 49
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2022-04-01
Completion Date: 2023-03-31
Locations: Northern Michigan University, Marquette, Michigan, 49855, United States

Summary:
The purpose of this study was to determine the acute effects of different manual cupping therapy protocols on ankle range of motion, compared to sham treatments, in generally healthy adults with limited ankle range of motion (i.e., ankle dorsiflexion less than 40 degrees).

Primary Outcome Measures: Change in average ankle dorsiflexion (degrees) using a digital inclinometer, Weight bearing ankle dorsiflexion measured by performing a modified lunge and bringing the knee forward as far as possible without allowing the heel to come off of the ground. A digital inclinometer was placed vertically over the tibial tuberosity and the measurement was reported as the average of three trials, in degrees., Baseline and immediately after receiving treatment.
Evaluation of Erythropoietin on Alveolar Ridge Preservation
NCT Number: NCT06513039
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Alveolar Bone Loss
Interventions: DRUG: Erythropoietin carried on chitosan carrier|OTHER: chitosan carrier
Sponsor: Ain Shams University
Sex: ALL
Age: ADULT
Enrollment: 15
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-01-01
Completion Date: 2025-01-01
Locations: Faculty of Dentistry Ain Shams University, Cairo, 11361, Egypt

Summary:
regenerative materials would help in decreasing post-extraction resorption in sites indicated for placement of a conventional bridge or prosthetically driven implant. Erythropoietin (EPO) is a growth factor that promotes angiogenesis and bone regeneration by stimulating osteoblastic differentiation and by inhibiting osteoclastic resorption. Post-extraction alveolar ridge resorption creates morphological and volumetric changes. These changes can be considered of clinical value that may threaten the placement of a conventional bridge or an implant-supported crown. Atwood et al. \[1\] in a cephalometric study categorized factors influencing the rate of alveolar ridge resorption into 4 types: anatomic, metabolic, functional, and prosthetic. As stated by Tan et al. \[2\] in a systematic review of alveolar hard and soft tissue dimensional changes in humans post-extraction, they found that alveolar ridge resorption occurs to a greater extent in a horizontal direction than vertical. Therefore, alveolar ridge preservation (ARP) procedures were introduced in an attempt to prevent hard and soft tissue dimensional changes following extraction.

Primary Outcome Measures: Dimensional changes, Clinical measurement using bone caliper. Radiographic measurement using CBCT, six months
Secondary Outcome Measures: Postoperative Pain level Postoperative wound Healing Patterns of bone regeneration of extraction socket, Visual analogue scale., six months
MgSO4 as Adjuvants to Bupivacaine vs Neostigmine in TAP Block in Cesarean Section
NCT Number: NCT06513013
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2|PHASE3
Conditions: Cesarean Section
Interventions: PROCEDURE: transversus abdominis plane (TAP) block in cesarean section|DRUG: Magnesium sulfate|DRUG: Neostigmine
Sponsor: Assiut University
Sex: FEMALE
Age: ADULT
Enrollment: 68
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-20
Completion Date: 2026-12

Summary:
The aim of this study is to compare the duration of analgesia obtained by addition of Neostigmine versus MgSO4 as adjuvants to bupivacaine in TAP block in patients undergoing Cesarean Section and to evaluate postoperative analgesic requirements, side effects and level of patient satisfaction.

Primary Outcome Measures: comparasion of Postoperative NRS score for 24 hours between the two groups, NRS Score: used to assess pain intensity (13). It is one of the most commonly used pain scales in medicine. The NRS consists of a numeric version of the visual analog scale. It is a horizontal line with an eleven point numeric range. It is labeled from zero to ten, with zero being an example of someone with no pain and ten being the worst pain possible (Figure 2). This scale can be administered verbally. Rescue analgesia will be nalbuphine 0.1 mg/kg IV when the NRS ≥ 4., 24 hours postoperative
Secondary Outcome Measures: postoperative hemodynamic parameters, Hemodynamic parameters including HR, 24 hours postoperative|time required for the first rescue analgesia, the time at wich the patient demand analgesia will be record for each patient, 24 hours postoperative|total amount of rescue analgesic consumption duringfirst 24 hours postoperatively, total amount of rescue analgesic consumption duringfirst 24 hours postoperatively, 24 hours postoperative|patient satisfacation score, five-point likert scale: to evaluate the patient satisfacation regarding the

to evaluate the patients' satisfaction regarding the whole procedure at the end of the postoperative 24 hours. It ranged from (1=very satisfied, 2=satisfied, 3=neither satisfied nor dissatisfied, 4=dissatisfied, 5=very dissatisfied), 24 hours postoperative|PONV intensity by postoperatively:, The number of attacks of nausea for 24 h will be assessed at 0.5, 1, 2, 4, 6, 12 and 24 h and will be recorded as yes/no.

* The number of attacks of vomiting for 24 h will be assessed at 0.5, 1, 2, 4, 6, 12 and 24 h postoperatively and will be recorded as yes/no., 24 hours postoperative
Dryness Difference Between Before and After Phacoemulsification
NCT Number: NCT06513000
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Dry Eye
Interventions: DIAGNOSTIC_TEST: Dry eye diagnostic system
Sponsor: Sohag University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-12
Completion Date: 2025-03
Locations: Sohag university hospital, Sohag, Egypt

Summary:
The aim of this study is to compare tear film and tear film secretion before and after phacoemulsificaton cataract surgery

Primary Outcome Measures: Evaluation Of Dryness Post Phacoemulcification In Non Complicated Cases using tear film break up time in seconds., Analysis of dryness before and after uncomplicated phacoemulsification using tear film break up time in seconds., Before the operation and 2-week and 1, 3, and 6 month after the operation|Evaluation Of Dryness Post Phacoemulcification In Non Complicated Cases using tear meniscus height in millimeters., Analysis of dryness before and after uncomplicated phacoemulsification using tear meniscus height in millimeters., Before the operation and 2-week and 1, 3, and 6 month after the operation|Evaluation Of Dryness Post Phacoemulcification In Non Complicated Cases using Lipid layer thickness in nanometers., Analysis of dryness before and after uncomplicated phacoemulsification using Lipid layer thickness in nanometers.., Before the operation and 2-week and 1, 3, and 6 month after the operation
Impact of Interactive ICU Diary on Psychological Distress
NCT Number: NCT06512987
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Critical Illness
Interventions: OTHER: technology-driven, interactive ICU diary
Sponsor: Taipei Medical University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 56
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-08-01
Completion Date: 2025-02-28
Locations: Taipei Medical University Hospital, Taipei, 110, Taiwan

Summary:
This study investigates the effectiveness of a technology-driven, interactive ICU diary in reducing psychological distress, specifically anxiety, depression, and stress, in ICU patients. A single-blind, parallel-group randomized controlled trial will include 56 conscious ICU patients. The primary outcome measures are the Depression, Anxiety, and Stress Scale-21 (DASS-21) and the EuroQol instrument (EQ-5D), assessed at ICU admission, discharge, and one month post-discharge.

Primary Outcome Measures: Psychological Distress Levels (DASS-21), The primary outcome will be the psychological distress levels measured by the Depression, Anxiety, and Stress Scale-21 (DASS-21). This scale assesses anxiety, depression, and stress in ICU patients through 21 items, each rated from 0 ("Did not apply to me at all - Never") to 3 ("Applied to me very much, or most of the time - Almost always"). The total score for each subscale (DASS-21-Depression, DASS-21-Anxiety, and DASS-21-Stress) ranges from 0 to 21, with higher scores indicating greater emotional distress. The cutoff scores for DASS-21-Depression, DASS-21-Anxiety, and DASS-21-Stress are \>9, \>7, and \>14, respectively., 7 days after admission and one month post-discharge.
Secondary Outcome Measures: Quality of Life (EQ-5D), The secondary outcome will be the quality of life measured by the EuroQol instrument (EQ-5D-3L). This instrument includes five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is scored with three levels: no problems (1), some problems (2), and extreme problems (3). The EQ-5D index score, derived using a pre-established conversion formula from neighboring countries like Japan or the UK, ranges from 0 to 1, with higher scores indicating better quality of life. Additionally, the EQ-VAS, a visual analogue scale from 0 (worst imaginable health) to 100 (best imaginable health), will be used to assess self-perceived health status. The EQ-VAS score will be recorded directly by marking a vertical scale., 7 days after admission and one month post-discharge.
Early Surgical Effects and Influencing Factors of High Tibial Osteotomy in the Treatment of Knee Osteoarthritis
NCT Number: NCT06512948
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Osteoarthritis, Knee
Interventions: PROCEDURE: High tibial osteotomy
Sponsor: Shufeng Li
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 78
Study Design: Observational Model: |Time Perspective: p
Start Date: 2021-01-01
Completion Date: 2021-12-01
Locations: The First Affiliated Hospital of Shandong First Medical University, Jinan, Shandong, 270000, China

Summary:
Exploring the factors influencing postoperative functional recovery after high tibial osteotomy

Primary Outcome Measures: Imaging parameters, Medial proximal tibial angle, an average of 1 year after the surgery|Imaging parameters, Opening gap, an average of 1 year after the surgery|Imaging parameters, the weight bearing line ratio, an average of 1 year after the surgery|Imaging parameters, joint line convergence angle, an average of 1 year after the surgery|Imaging parameters, Hip-knee-ankle, an average of 1 year after the surgery|Imaging parameters, opening angle, an average of 1 year after the surgery
Secondary Outcome Measures: function score, the US Hospital for special surgery knee-rating score, an average of 1 year after the surgery|function score, American knee society knee score, an average of 1 year after the surgery|function score, Lysholm, an average of 1 year after the surgery|function score, Western Ontario and McMaster Universities Osteoarthritis Index, an average of 1 year after the surgery
Ventilator Pressure and Optimization of Compliance and Hemodynamics
NCT Number: NCT06512935
Acronym: VPOCH
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Bronchopulmonary Dysplasia|Pulmonary Hypertension Due to Lung Diseases and Hypoxia|Extreme Prematurity|Ventilator Lung; Newborn|Ventilation Perfusion Mismatch
Interventions: OTHER: Increase in the PEEP followed by decrease in the PEEP|OTHER: Decrease in the PEEP followed by increase in the PEEP
Sponsor: University of Alabama at Birmingham
Sex: ALL
Age: CHILD
Enrollment: 24
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-10-01
Completion Date: 2025-12-31

Summary:
In preterm infants \< 34 weeks' gestation at birth receiving respiratory support with invasive positive pressure ventilation, the positive end-expiratory pressure (PEEP) of best compliance will increase the cardiac output and improve oxygenation. This study may emphasize using point-of-care echocardiography along with electrical impedance tomography (EIT) to optimize ventilator settings in preterm infants.

Infants will be randomized to a 4-hour crossover period of increasing and decreasing PEEP in random order from baseline to determine compliance, oxygenation, and cardiac hemodynamics at each step using echocardiography (ECHO) and EIT measurements. There will be a 15-minute washout period after changes prior to data collection.

Primary Outcome Measures: Change in cardiac index with increase/decrease in PEEP as measured by ECHO and EIT, During a 4 hour cross-over period on either intervention|PEEP of best compliance and best oxygenation as per EIT measurements, During a 4 hour cross-over period on either intervention
Secondary Outcome Measures: Tidal volume variation, During a 4 hour cross-over period on either intervention|Oxygen saturation index, During a 4 hour cross-over period on either intervention|End-expiratory lung impedance (EELI), End-inspiratory lung impedance (EILI), During a 4 hour cross-over period on either intervention|Transcutaneous carbon dioxide (TcCO2) values in response to varying PEEP levels, During a 4 hour cross-over period on either intervention|Respiratory Severity Score (RSS), RSS: mean airway pressure (MAP) x fraction of inspired oxygen (FiO2), During a 4 hour cross-over period on either intervention|oxygen saturation (SpO2) values, During a 4 hour cross-over period on either intervention|% tidal distribution, During a 4 hour cross-over period on either intervention
Effects of Virtual Reality Glasses and Stress Ball Application on Pain, Anxiety and Patient Satisfaction in Intramuscular Injection Application
NCT Number: NCT06512909
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Pain and Anxiety During Intramuscular Injection
Interventions: OTHER: Virtual Reality Glasses Application|OTHER: Stress Ball Application
Sponsor: Necmettin Erbakan University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 120
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-07-22
Completion Date: 2024-09-18

Summary:
Purpose: This study was planned to examine the effects of virtual reality glasses and stress ball application on pain, anxiety and patient satisfaction in intramuscular injection application.

Material method: The data of the research were collected using "Sociodemographic Characteristics Form", "Visual Comparison Scale (VAS-VAS)", "Satisfaction Assessment Scale (MDS)" and "Visual Analog Anxiety Scale (VAS-A)". will be collected using .

Results: Findings will be presented in tables. Conclusion and recommendations: As a result, it is expected that the use of stress balls and virtual reality glasses in intramuscular application will be positive.

Primary Outcome Measures: Visual Comparison Scale-Assessing pain with Visual Analog Scale, According to VAS, pain intensity is rated as "no pain" as 0 points and "the worst pain imaginable" as 10 points (Eti Aslan, 2002). Pain intensity ranges determined by VAS; A score below 3 points was defined as mild pain, between 3 and 6 points as moderate pain, and above 6 points as severe pain., 1 minute after application|Assessing anxiety level with the Visual Analog Anxiety Scale, It is a measurement tool with a length of 10 cm, representing 0 points for "no anxiety" and 10 points for "I feel a lot of anxiety", and its evaluation is scored between 0-10. As the patient's anxiety level approaches 10, it indicates that his anxiety increases., Before application and 1 minute after application|Evaluating patient satisfaction with the Satisfaction Rating Scale, Patients' post-injection satisfaction was evaluated using a scale consisting of a 100 mm long vertical line with the words "Very Satisfied" on one end and "Not at all satisfied" on the other end., 1 minute after application
Clinical Study on Intraluminal Injection of FOLactis
NCT Number: NCT06512896
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Solid Tumor|Immune Response|Pleural Effusion, Malignant|Peritoneal Effusion
Interventions: OTHER: FOLactis
Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-05-01
Completion Date: 2026-05-30
Locations: The Comprehensive Cancer Centre of Nanjing Drum Tower Hospital, Medical School of Nanjing University & Clinical Center Institute of Nanjing University, Nanjing, China, Nanjing, China

Summary:
This clinical study is a single arm, prospective, single center clinical study on the safety, tolerability, and preliminary efficacy of a novel FOLactis in situ vaccine in the treatment of advanced solid tumors with malignant pleural and peritoneal effusion. The safety, tolerability and preliminary efficacy of intraluminal injection of FOLactis combined with systemic anti-tumor therapy will be evaluated.

Primary Outcome Measures: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0, Evaluate the safety and tolerability of intraluminal injection of FOLactis combined with systemic anti-tumor therapy, three years
Secondary Outcome Measures: Objective Response Rate, Observation and evaluation of the preliminary efficacy of FOLactis in patients with advanced solid tumors accompanied by malignant pleural and peritoneal effusion, three years|Progression Free Survival, Changes in the levels of cytokines and lymphocyte subsets in the pleural and peritoneal effusion/peripheral blood of subjects before and after FOLactis treatment;, three years|Overall Survival, 1) The changes in pleural and peritoneal effusion/peripheral blood tumor markers in subjects before and after FOLactis treatment; 2) Changes in tumor microenvironment in the chest and abdominal cavities of subjects before and after FOLactis treatment., three years
A Trial to Investigate Benralizumab in Children With Eosinophilic Diseases
NCT Number: NCT06512883
Acronym: CLIPS
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Eosinophilic Granulomatosis With Polyangiitis (EGPA)
Interventions: DRUG: Benralizumab
Sponsor: AstraZeneca
Sex: ALL
Age: CHILD
Enrollment: 14
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-02
Completion Date: 2027-09-10
Locations: Research Site, Aurora, Colorado, 80045, United States|Research Site, Toronto, Ontario, M5G1X8, Canada|Research Site, Guadalajara, 44620, Mexico|Research Site, Altındağ, 06230, Turkey

Summary:
The main purpose of study is to assess the safety, tolerability, and pharmacokinetic (PK) of benralizumab.

Primary Outcome Measures: Number of Participants with Adverse Events (AEs), The safety and tolerability of benralizumab will be evaluated., From screening (Week -4 to -1) until Week 52|Serum Concentrations of Benralizumab, The PK of benralizumab will be evaluated., Weeks 0, 12, 24, 25, 36, and 52
Secondary Outcome Measures: EGPA Cohort: Percentage of Participants with Remission at Week 24, Remission defined as Paediatric Vasculitis Activity Score (PVAS) = 0 and oral corticosteroid (OCS) intake less than or equal to (\<=) 0.1 mg/kg/day., At Week 24|Number of Participants with Positive Antidrug Antibody (ADA), The immunogenicity of benralizumab will be evaluated., Weeks 0, 12, 24, 36, 48, and 52|Change From Baseline in Peripheral Blood Eosinophil Count, The PD effect of benralizumab on peripheral blood eosinophil count will be evaluated., From Baseline to Weeks 0, 12, 24, 36, 52|EGPA Cohort: Time to First EGPA Relapse, The efficacy of benralizumab on time to first relapse will be assessed. EGPA relapse will be defined as worsening or persistence of active disease since the last visit characterized by: a) Active vasculitis (PVAS \> 0); OR b) Worsening of asthma symptoms (based on Asthma Control Questionnaire - Interviewer Administered \[ACQ-IA\]); OR c) Active nasal and/or sinus disease with worsening in at least one sino-nasal symptom question warranting any of the following: 1) Increase OCS; OR 2) Increase/addition of immunosuppressive medication; OR 3) Hospitalisation related to EGPA worsening., Up to 52 weeks
The Effect of Hand Puppets and Kaleidoscope on Pain and Fear in Preschool Children
NCT Number: NCT06512857
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Nursing Caries|Pain|Fear of Pain
Interventions: OTHER: Hand puppet method|OTHER: Kaleidoscope method
Sponsor: Firat University
Sex: ALL
Age: CHILD
Enrollment: 75
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-05-10
Completion Date: 2024-07-05
Locations: Özlem Selime Merter, Elazig, 23119, Turkey

Summary:
This study aimed to determine the effects of hand puppets and kaleidoscopes on some emotional parameters in preschool children who underwent skin prick testing at the pediatric allergy and immunology outpatient clinic.The study was conducted with children aged 3-6 years who underwent skin prick testing for allergy testing.In the study, the Introductory Characteristics of Children and Their Families Form, Wong-Baker Faces Pain Rating Scale (FACES) and Child Fear Scale (CFS) were used to store data.The data were uploaded to the computer and coded by the researchers, and the data were evaluated in the SPSS package program. Sociodemographic data of the children participating in the study are given as numbers and percentage distributions. The data were analyzed according to normal distribution and appropriate tests were used. The statistical significance level of the research was determined as p\<0.05. In addition, at the end of the study, with a sufficient sample size, working status was tested with post-hoc power analysis.

Primary Outcome Measures: WONG-BAKER FACES PAIN RATING SCALE, In this scale, faces are given pain scores according to numerical values. The lowest score is "0" and the highest score is "10". As the score from the scale increases, the intensity of pain increases, and as the score decreases, the intensity decreases., day 1
Secondary Outcome Measures: Children's Fear Scale, 5 cartoon face pictures were used in the scale. Anxiety level is evaluated with numbers between "0" and "4". A score of "0" indicates "no anxiety" and a score of "4" indicates "severe anxiety"., day 1
MBSR for Improving Emotional Intelligence in Adolescents With Physical Disability
NCT Number: NCT06512844
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Physical Disability
Interventions: BEHAVIORAL: Mindfulness Based Stress Reduction (MBSR) Intervention
Sponsor: Fatima Jinnah Women University
Sex: ALL
Age: CHILD, ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-05-12
Completion Date: 2024-06-24
Locations: Aleeza Sohail, Islamabad, Federal, 04403, Pakistan

Summary:
This study aims to provide evidence on the effectiveness of mindfulness-based interventions in enhancing emotional intelligence and managing psychosocial challenges in adolescents with physical disabilities, potentially offering a valuable tool for improving their overall well-being.

Does the mindfulness-based intervention improve emotional intelligence in adolescents with physical disabilities? Does the psychosocial factors like psychological distress, self-compassion improve during the intervention? Are there any adverse effects associated with the mindfulness-based intervention? Researcher will give intervention and compare the control and experimental group in Time 1 and Time 2 respectively

Primary Outcome Measures: Emotional Intelligence, Improvement in emotional intelligence as measured by Schuttle Self Report Emotional Intelligence Test scores. The High Scores means more emotionally intelligent high Emotional Intelligence scores are typically above 123, average EI scores range from 90 to 122; and low EI scores are below 89 which means not that emotionally intelligent, 8 weeks
Isoniazid Prophylaxis Based on Risk Factors of Tuberculosis in Living Kidney Transplantation Recipients
NCT Number: NCT06512831
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Kidney Transplantation|Tuberculosis|Isoniazid Toxicity
Interventions: DRUG: Isoniazid
Sponsor: West China Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1348
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2023-06-01
Completion Date: 2024-03-01
Locations: West China Hospital, Sichuan University, Chengdu, Sichuan, 610041, China

Summary:
Tuberculosis (TB) is a major and severe opportunistic infection among solid organ transplant recipients. Chemoprophylaxis is advised for those with latent tuberculosis infection (LTBI). However, the effectiveness of an isoniazid (INH) prophylactic approach based on TB risk factors, without relying on tuberculin skin test (TST) or interferon-gamma release assay (IGRA), remains uncertain. Therefore, the investigators conducted this retrospective study to evaluate the safety and efficacy of a 6-month INH prophylaxis regimen guided by TB risk factors in kidney transplant recipients.

Primary Outcome Measures: The incidence of post-transplant active TB, from transplant to post-transplant for up to 5 years
Secondary Outcome Measures: The incidence of side effects of INH, Within 6 months of INH regimen
a Retrospective Study on the Systemic Treatment of LPP and FFA
NCT Number: NCT06512766
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Cicatricial Alopecia|Lichen Planopilaris|Lichen Plano-Pilaris|Frontal Fibrosing Alopecia|Hair Diseases|Scarring Alopecia|Hair Loss/Baldness
Interventions: DRUG: Hydroxychloroquine|DRUG: Methotrexate|DRUG: Cyclosporine A|DRUG: Retinoids
Sponsor: Erasmus Medical Center
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 315
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-09-23
Completion Date: 2023-02-01
Locations: Erasmus MC, Rotterdam, Zuid-Holland, 3015GD, Netherlands

Summary:
This retrospective study aims to assess the effectiveness of systemic treatments for lichen planopilaris (LPP) and frontal fibrosing alopecia (FFA) in patients treated at the Erasmus MC University Medical Center. LPP and FFA are chronic inflammatory hair disorders leading to irreversible hair loss. The study evaluates treatment responses to systemic medications, including hydroxychloroquine, methotrexate, cyclosporine A, and retinoids.

Primary Outcome Measures: Treatment response, The primary outcome measure is the treatment response of systemic treatment options in patients diagnosed with LPP and FFA. Treatment response is categorized into three groups: no response (progression of symptoms, hair loss, and trichoscopic activity), moderate response (improvement in symptoms, reduced hair loss progression, or reduction in trichoscopic activity), and good response (absence of symptoms, no further hair loss, and no trichoscopic activity)., The time frame for evaluating treatment response varies per patient due to the retrospective nature of the study. Patients were treated and assessed at various intervals between July 2016 and July 2022.
Secondary Outcome Measures: Reason for discontinuation, This secondary outcome measure assesses the discontinuation rates of systemic treatments (HCQ, MTX, CsA, and retinoids) and the reasons for discontinuation, such as side effects or insufficient treatment effects., The time frame for evaluating reason for discontinuation varies per patient due to the retrospective nature of the study. Patients were treated and assessed at various intervals between July 2016 and July 2022.
The Effectiveness of Hydroxychloroquine Versus Methotrexate in the Treatment of Lichen Planopilaris in Routine Clinical Care: a Patient Preference Trial
NCT Number: NCT06512753
Acronym: HEMLET
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Lichen Planopilaris|Cicatricial Alopecia
Interventions: DRUG: Hydroxychloroquine|DRUG: Methotrexate
Sponsor: Erasmus Medical Center
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 56
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-01
Completion Date: 2026-07-01
Locations: Erasmus MC, Rotterdam, Zuid-Holland, 3015GD, Netherlands

Summary:
Rationale Lichen planopilaris (LPP) is a prevalent form of cicatricial alopecia, predominantly affecting women and causing irreversible hair loss. Hydroxychloroquine (HCQ) and methotrexate (MTX) are the most frequently used systemics for treatment of LPP in daily practice. Due to the absence of well-established treatment guidelines, this study aims to evaluate the effectiveness of HCQ and MTX in routine clinical care.

Objective(s) To investigate the effectiveness of HCQ and MTX in the treatment of adults with lichen planopilaris in routine clinical care.

Study type Prospective, patient preference clinical trial with a duration up to 48 weeks in accordance with the routine clinical care guidelines.

Study population This study will include adults (≥18 years) diagnosed with LPP.

Methods Patients will choose between HCQ and MTX treatment as in routine clinical care, receiving follow-up in accordance with standard clinical practices. They will not be randomized. The primary endpoint is the measurement of the Lichen Planopilaris Activity Index (LPPAI) at the 6-months, providing a quantitative assessment of the disease's activity and response to the selected treatment. The Skindex-29 questionnaire will be conducted at each visit, allowing evaluation of the impact on patients' quality of life.

Primary Outcome Measures: LPPAI, The main study parameter is the change in Lichen PlanoPilaris Activity Index (LPPAI) measured at 6 months (0-10)., at 24 weeks
Secondary Outcome Measures: LPPAI, The main study parameter is the change in Lichen PlanoPilaris Activity Index (LPPAI) measured (0-10)., at 0, 12, 36, 48 weeks|Skindex-29, Quality of Life, at 0, 12, 24, 36, 48 weeks|Side effects, Number of side effects, at 0, 12, 24, 36, 48 weeks