pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Effect of Stress Ball on Perceived Stress, Pain and Satisfaction in Cancer Patients
NCT Number: NCT06522503
Status: ENROLLING_BY_INVITATION
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cancer
Interventions: BEHAVIORAL: stress ball
Sponsor: Izmir Bakircay University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 74
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-01-01
Completion Date: 2024-07-30
Locations: Ayşegül Çelik, Izmir, Menemen, 35665, Turkey

Summary:
The objective of this study was to ascertain the impact of stress ball utilisation on perceived stress, pain and satisfaction levels during port catheter intervention in cancer patients. In this study, which was conducted in a randomised controlled design, a control group of cancer patients receiving chemotherapy (n=37) was assigned to receive standard care during port catheter needle insertion. An intervention group (n=37) was also formed, comprising patients who received stress ball application in addition to standard care. The intervention group was provided with a stress ball in both hands five minutes prior to the insertion of the port catheter needle and instructed to squeeze the ball in their hands at regular intervals until the conclusion of the procedure. Prior to the application, the descriptive characteristics of both groups were ascertained, and their perceived stress levels were assessed. Subsequently, the pain and perceived stress levels of both groups were documented. Additionally, the satisfaction levels of the intervention group regarding the stress ball application were evaluated.

Primary Outcome Measures: perceived stress level, Perceived Stress Scale: The Perceived Stress Scale, comprising a total of 14 items, has been developed to assess the degree to which an individual perceives specific circumstances in their life as stressful. The scale is a 5-point Likert-type scale, with each item ranging from "Never (0)" to "Very often (4)". The total score obtained from the scale is indicative of the individual's stress level., baseline and end of the port catheterisation procedure (mean time 10 minutes)
Secondary Outcome Measures: pain level, The Visual Analogue Scale (VAS): The Visual Analogue Scale is a frequently employed instrument for the assessment of pain intensity. It is a unidimensional scale with a length of 0-10 cm. The scale is anchored at 0 cm, which is defined as no pain, and 10 cm, which is defined as unbearable pain. As the score obtained from the scale increases, the pain intensity also increases., End of the port catheterisation procedure (mean time 10 minutes)
Other Outcome Measures: patient satisfaction level, Visual Analog Scale-Satisfaction Level (VAS): The Visual Analogue Scale (VAS), comprising a 10-cm line, represents a valid and reliable instrument for measuring subjective emotions such as mood. In this study, a visual analogue scale (VAS) was employed as a means of evaluating patient satisfaction levels., End of the port catheterisation procedure (mean time 10 minutes)
Effects of Virtual Discrete Trial Training on Children With Autism Spectrum Disorder
NCT Number: NCT06522490
Acronym: VDT
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Autism Spectrum Disorder
Interventions: OTHER: Virtual discrete trial training
Sponsor: Riphah International University
Sex: ALL
Age: CHILD
Enrollment: 10
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2023-11-02
Completion Date: 2024-02-01
Locations: Pakistan society for rehabilitation of differently abled, Lahore, Punjab, Pakistan

Summary:
Autism spectrum disorder (ASD) is a neurodevelopmental disorder categorized by deficits in social communication and the occurrence of restricted interests and repetitive behaviors. The cautionary needs of children with ASD are significant, it affects parents and siblings as well and requires substantial social support. If adequate intervention is not provided to children with ASD on time, then they may face many difficulties for example in academic work. They face social isolation and may develop additional challenging behaviors. Applied behavior analysis (ABA) is one of the most commonly used supported treatments for autism spectrum disorder. Discrete Trial Training (DTT) is one of the most structured Applied Behavior Analysis (ABA) types. DTT is the best standardized therapy for ASD. The ABA explores human interactions with their environment over time and develops interventional strategies to diminish the decline in the troublesomeness of social behavior among individuals with ASD. DTT through video training Program will be an effective in improving the communication skills of children with ASD. The video training program offers excellent accessibility and is inexpensive because it can be administered remotely and at home as well. It also reduces the resource barrios.

A randomized controlled study was conducted on children aged between 3-10 years diagnosed with ASD at PSRD hospital having Different severity levels. DTT was provided through a video training program using digital technology with informed consent from their caregivers/parents. The sample size was 10. Both groups contain 5 participants. The treatment group will be trained on DTT through the video training program. Sessions were conducted thrice a week for 45 minutes. The duration of the experiment was 12 weeks. The control group did not intervene with the video training program during the experiment. Pre \& Post language assessment was done through British Picture Vocabulary Scale.

Primary Outcome Measures: British Picture Vocabulary Scale, It helps you identify any delay in vocabulary development, even before children are in full-time education. BPVS3 is a one-to-one test in a simple and easy to administer format. For each question, you say a word and the pupil responds by selecting a picture from four options that best illustrates that word's meaning, 3 months
Usability Evaluation of a Mindfulness-based Serious Game
NCT Number: NCT06522425
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Pain, Chronic
Interventions: OTHER: mindfulness-based serious games
Sponsor: Samsung Medical Center
Sex: ALL
Age: CHILD
Enrollment: 19
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: OTHER
Start Date: 2023-11-02
Completion Date: 2024-06-17
Locations: Samsung Medical Centre, Seoul, 06351, Korea, Republic of

Summary:
The purpose of this study is to evaluate the usability of a mindfulness-based serious game developed for pediatric and adolescent patients who require pain management during their disease treatment. We conducted usability evaluations targeting both professional and user groups. Both groups experienced the mindfulness-based serious game and then participated in a usability survey and interview.

Primary Outcome Measures: Usability Evaluation of the Mindfulness-Based Serious Game, The usability of the mindfulness-based serious game will be measured using the Mobile Application Rating Scale (MARS) and its user version (uMARS). These scales assess the app's engagement, functionality, aesthetics, information, subjective quality and app-specific quality., Immediately post-intervention
Secondary Outcome Measures: Qualitative Feedback from Interviews, Qualitative feedback will be collected through interviews conducted immediately after the intervention. These interviews will gather detailed insights into participants' experiences, including the game's usability, perceived benefits, ease of use, and overall satisfaction., Immediately post-intervention
Outcome of TAMIS Mucosal Resection in Patients With ODS
NCT Number: NCT06522399
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Constipation, Impaction, and Bowel Obstruction|TAMIS Mucosectomy|Obstructed Defecation Syndrome
Interventions: PROCEDURE: TAMIS mucosectomy
Sponsor: Medical University of Vienna
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 11
Study Design: Observational Model: |Time Perspective: p
Start Date: 2021-08-01
Completion Date: 2023-10-01
Locations: Medical University of Vienna, Vienna, 1090, Austria

Summary:
Patients, aged 18 - 90 years, undergoing TAMIS mucosectomy at the Department of General Surgery at the Medical University of Vienna are enrolled into our study.

Primary endpoint is the outcome (improvement of ODS symptoms), defined by ODS score.

Primary Outcome Measures: functional outcome assessment, functional outcome defined by ODS score, 6 months
Secondary Outcome Measures: fecal incontinence assessment, fecal incontinence improvement or worsening measured by using the VAIZEY Score, 6 months|Quality of life assessment, Health-related quality of life after TAMIS in ODS patients, defined by Quality of Life Score (SF12)., 6 months
GATE1: A Multicenter Phase II Study of Pirtobrutinib, Rituximab and Venetoclax Combination Therapy for Patients With Previously Untreated Mantle Cell Lymphoma
NCT Number: NCT06522386
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Mantle Cell Lymphoma
Interventions: DRUG: Pirtobrutinib|DRUG: Rituximab|DRUG: Venetoclax
Sponsor: M.D. Anderson Cancer Center
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2025-12-01
Completion Date: 2029-02-28
Locations: MD Anderson Cancer Center, Houston, Texas, 77030, United States

Summary:
Primary Objectives:

To estimate the percent of participants who achieve a best response of complete response by the end of the PRV combination therapy in the induction therapy phase in patients with previously untreated MCL.

Primary Outcome Measures: Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0, Through study completion; an average of 1 year.
Phase I Trial of MT-0169 in CD38+ Acute Leukemia With Relapsed/Refractory or Measurable Residual Disease
NCT Number: NCT06522373
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Leukemia
Interventions: DRUG: MT-0169
Sponsor: M.D. Anderson Cancer Center
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 52
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-12-01
Completion Date: 2030-07-01
Locations: MD Anderson Cancer Center, Houston, Texas, 77030, United States

Summary:
To learn if MT-0169 is safe to give to patients with AML or T-ALL. The effects of this drug will also be studied.

Primary Outcome Measures: Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0, Through study completion; an average of 1 year.
Brigatinib Plus Chemotherapy or Local Consolidation Therapy in ALK Positive Advanced Non-small Cell Lung Cancer (BrightStar-2)
NCT Number: NCT06522360
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Non-small Cell Lung Cancer
Interventions: DRUG: Brigatinib|DRUG: Carboplatin|DRUG: Pemetrexed
Sponsor: M.D. Anderson Cancer Center
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 168
Study Design: Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2025-12-01
Completion Date: 2031-12-30
Locations: MD Anderson Cancer Center, Houston, Texas, 77030, United States

Summary:
The goal of this clinical research study is to learn if the combination of brigatinib and either local consolidation therapy (such as radiotherapy or surgery) or chemotherapy (pemetrexed and carboplatin) can help to control the disease compared with brigatinib alone. The safety of these combinations will also be studied.

Primary Outcome Measures: Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0, Through study completion; an average of 1 year
Mycobacteria Registry Study: Prospective Observational Study in Austria
NCT Number: NCT06522347
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Non-Tuberculous Mycobacterial Pneumonia|Tuberculosis
Sponsor: Ludwig Boltzmann Institute for Lung Health
Collaborators: Sigmund Freud PrivatUniversitat
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-01-01
Completion Date: 2053-12-31
Locations: Klinik Hietzing, Vienna, 1130, Austria|Klinik Penzing, Vienna, 1140, Austria|Ludwig Boltzmann Institut for Lung Health, Vienna, 1140, Austria

Summary:
The goal of this non-interventional registry study is to systematically collect epidemiological and clinical data throughout the treatment course to learn about effectiveness of treatments. We will document the natural course of therapy without additional interventions. The main question to answer is:

What are the risk factors for mortality due to infection with Mycobacteria tuberculosis (TB) or Nontuberculous mycobacteria (NTM) in Austria?

Data from participants already receiving treatment as part of their regular medical care for TB or NTM infections will be collected.

Primary Outcome Measures: Mortality, Mortality due to tuberculosis or NTM infection in Austria, 30 years
Secondary Outcome Measures: Prevalence, Prevalence of mycobacterial infections in Austria, 30 years|Patient cohort, Description of the patient cohort, 30 years|Risk factors, Identification of risk factors for treatment failure and complications, 30 years
Interstitial Lung Disease Registry Study: Prospective and Retrospective Observational Study in Austria
NCT Number: NCT06522334
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Interstitial Lung Disease
Sponsor: Ludwig Boltzmann Institute for Lung Health
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 400
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-02-28
Completion Date: 2034-02-28
Locations: Klinik Hietzing, Wien, 1130, Austria|Klinik Penzing, Wien, 1140, Austria|Ludwig Boltzmann Institut for Lung Health, Wien, 1140, Austria|Klinik Ottakring, Wien, 1160, Austria|Klinik Floridsdorf, Wien, 1210, Austria

Summary:
The goal of this registry is to systematically record epidemiological and clinical data throughout the whole interstitial lung disease course - starting with the diagnosis, therapy, follow up of lung function, symptom control, adverse events, medication, survival and death.

There are no additional interventions regarding this registry.

Primary Outcome Measures: Mortality, Mortality caused by interstitial lung disease, 10 years|Loss of lung function, FVC and DLCO loss within 24 months, 2 years
Secondary Outcome Measures: Prevalence, Prevalence of the different interstitial lung diseases in Austria, 10 years|Response to drugs, Response to immunosuppressive/immunomodulating/antifibrotic drugs, 10 years
Prevalence of Cholelithiasis With Umbilical Hernia
NCT Number: NCT06522308
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Umbilical Hernia|Cholelithiasis
Interventions: DIAGNOSTIC_TEST: Hepatobiliary ultrasound|DIAGNOSTIC_TEST: Umbilical region superficial tissue ultrasound
Sponsor: Konya Meram State Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 278
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-10-01
Completion Date: 2024-01-31
Locations: Konya Training and Research Hospital, Konya, 42090, Turkey

Summary:
Researchers aim to determine the exact prevalence and risk factors for the association of gallstones and umbilical hernia. Umbilical hernia is defined according to the European Hernia Society Classification for primary and incisional abdominal wall hernias as hernias occurring from 3 cm above to 3 cm below the umbilicus. The main outcome measures are the presence of gallstones in patients presenting with umbilical hernia and the presence of umbilical hernia in patients diagnosed with gallstones. Patients with umbilical hernia are examined with biliary ultrasound, while patients with cholelithiasis are evaluated for umbilical hernia by physical examination and ultrasound. Factors such as age, gender, body mass index (BMI), family history, comorbidities, tobacco use, parity, and history of multiple pregnancy are analyzed as potential risk factors.

Primary Outcome Measures: Presence of cholelithiasis in umbilical hernia patients, In umbilical hernia patients, the presence of cholelithiasis is determined by hepatobiliary ultrasound., 2 days|Presence of umbilical hernia in cholelithiasis patients, In patients with cholelithiasis, the presence of umbilical hernias is determined by superficial tissue ultrasound of the umbilical region., 2 days
Secondary Outcome Measures: Body mass index, Body mass index is calculated by dividing kilograms by height squared (kilograms / height squared)., 2 days|The female-male ratio, The female-male ratio is found by the number of females divided by the number of males (female/male ratio)., 2 days|Concomitant diseases ratio, It is found by dividing the number of patients with comorbidities by the total number of patients, 2 days
Identification of Molecular Signatures of High-risk Oncogenic HPV and Study of Their Associations With the Presence of High-grade Lesions and/or Anal Cancer 10 Years After Inclusion in the ANRS IPERGAY Trial
NCT Number: NCT06522256
Acronym: HPVsign
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: HPV Infection|Anal Cancer
Interventions: PROCEDURE: High-resolution anoscopy
Sponsor: ANRS, Emerging Infectious Diseases
Collaborators: INSERM SC10-US19
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-09-15
Completion Date: 2027-06-30
Locations: Hôpital de la Croix Rousse - SMIT, Lyon, 69004, France|Hôpital Saint-Louis - SMIT, Paris, 75010, France|Hôpital Tenon - SMIT, Paris, 75020, France

Summary:
HPVsign is a cross-sectional, non-comparative, multicenter study involving all participants included in the HPV substudy of the ANRS IPERGAY trial. The study proposes to evaluate the cumulative incidence of high-grade lesions and/or anal cancers using high-resolution anoscopy (HRA) during the HPVsign study and/or diagnosed since the end of participation in the ANRS IPERGAY trial.

Primary Outcome Measures: High-Grade Squamous Intraepithelial Lesion (HSIL) and/or anal cancers diagnosed by an high-resolution anoscopy (HRA), Within the 10 years prior to HPV sign study participation, or at the study proctological examination in the study.
Secondary Outcome Measures: HPV molecular signatures obtained using the Capture-HPV technique: HPV mutations, integration into the human genome, at the time of the ANRS IPERGAY-HPV sub-study, and 10 years later, in the HPVsign study.|Nature of abnormalities on High resolution anoscopy (HRA): condylomas, lesions., Lesions and condylomas are described as follows: location and type., 10 years after participation in the ANRS IPERGAY trial|Nature of abnormalities on anal cytology: lesions location, lesions type, lesions grade., at the time of the ANRS IPERGAY-HPV sub-study, and 10 years later, in the HPVsign study.|Nature of abnormalities on anal histology of lesions: location, type, grade, 10 years after participation in the ANRS IPERGAY trial|Presence of different HPV virus types in the oropharynx, at the time of the ANRS IPERGAY-HPV sub-study, and 10 years later, in the HPVsign study.
Post Exercise Recovery and FST
NCT Number: NCT06522230
Acronym: FST
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Exercise Therapy
Interventions: OTHER: Fascial Stretch Therapy
Sponsor: University of British Columbia
Sex: ALL
Age: ADULT
Enrollment: 5
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-09-01
Completion Date: 2025-06-30

Summary:
In this pilot study the focus is to assess the perceived impact of Fascial Stretch Therapy (FST) on post-exercise recovery in University athletes. The objective is to determine if FST can expedite recovery and enhance overall well-being by reducing muscle soreness and fatigue. The FST protocol will be implement by a certified FST level 2 practitioner. Upon completion of the FST intervention athletes will complete a self-assessment questionnaire. The study aims to provide empirical support for FST's efficacy in improving post-exercise recovery and contributing to the health and performance of university athletes.

Primary Outcome Measures: Perceptions of Fascial Stretch Therapy (FST) on Post-Exercise and Post-Training Recovery Among UBCO Varsity Athletes, This study aims to assess the perceptions of UBCO varsity athletes regarding the impact of Fascial Stretch Therapy (FST) on their post-exercise and post-training recovery. Participants will undergo a 30-minute FST intervention for four sessions over four weeks. Semi-structured interviews will be conducted with participants post-intervention to gain an understanding of their experiences with FST as part of their athletic training and conditioning., Interviews will be conducted within one week after the completion of the 4th FST session.
Secondary Outcome Measures: Improvement in overall range of motion and functioning, Assessed using the SF-36, a widely used tool for measuring health-related quality of life (HRQoL). All items are scored so that a high score defines a more favorable health state. In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Scores represent the percentage of total possible score achieved., through study completion, an average of 1 month|Improvement in overall range of motion - back, Assessed using the Revised Oswestry Disability Index (RODI) which evaluates perceived functional limitations related to lower back pain. Each of the 10 sections is scored separately (0 to 5 points each) and then added up (max total = 50). Higher scores are indicative of greater disability., through study completion, an average of 1 month|Improvement in overall range of motion - neck, Assessed using The Neck Disability Index (NDI) questionnaire which assesses perceived functional limitations related to neck pain. Each section is scored on a 0 to 5 rating scale, in which zero means 'No pain' and 5 means 'Worst imaginable pain'., through study completion, an average of 1 month
Prosthetic Rehabilitation of Lip and Palate Deformaties in Neonates Using Two Different Approaches
NCT Number: NCT06522217
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Evaluation
Interventions: DEVICE: nasoalveolar molding appliance|DEVICE: digital nasoalveolar molding appliance
Sponsor: Tanta University
Sex: ALL
Age: CHILD
Enrollment: 20
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, CARE_PROVIDER)|Primary Purpose: TREATMENT
Start Date: 2018-02-19
Completion Date: 2022-02-28
Locations: Faculty of Dentistry -Tanta university, Tanta, Gharbia, Egypt

Summary:
This study was conducted to compare the use of conventional nasoalveolar molding appliances and the use of digitally designed and produced nasoalveolar molding appliances in rehabilitating neonates born with unilateral complete cleft lip and palate.

Primary Outcome Measures: intraoral measurements, measuring 2 points the first is the intersegmental distance in (mm) and the second is the alveolar width in (mm), 3 -4 months|extraoral measurements, * Nostril height in (mm)
* Nasal dome height in (mm)
* Columella height in( mm)
* Nostril basal width in (mm)
* Nostril width in (mm), 3-4 months
Comparing the Gastric Emptying Times of Underweight and Healthy-weight School-aged Children
NCT Number: NCT06522204
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Preoperative Fasting
Interventions: DRUG: %5 Dextrose
Sponsor: Karaman Training and Research Hospital
Sex: ALL
Age: CHILD
Enrollment: 60
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SCREENING
Start Date: 2024-07-30
Completion Date: 2025-03-01
Locations: Karaman Training and Research Hospital, Karaman, Turkey

Summary:
In the recent literature, preoperative fasting times for pediatric patients are limited to one hour for clear fluids. Studies related to gastric emptying times mostly searched for normal-weight children. These studies have claimed that 3 mL/kg of clear liquid can be allowed up to 1 hour before surgery. There is a lack of interest in the gastric emptying time of underweight pediatric patients during the preoperative period. Recent studies suggest that underweight children may experience rapid gastric emptying. This trial compares the gastric volume and emptying time after ingesting 3 mL/kg clear fluid in underweight and normal-weight pediatric patients in the preoperative period.

Primary Outcome Measures: Gastric emptying time, Time until the gastric volume reaches the baseline level again, 90 minute after Dextrose ingestion
Secondary Outcome Measures: Antral cross-sectional area, Antral cross-Section Area (ACSA) (cm2) maximal anteroposterior diameter (D1) and longitudinal diameter (D2) will be measured with ultrasound and calculated with that mathematical formula:

ACSA(cm2) = Π x D1 x D2 / 4, Every 5 minute until the ACSA decreased to the baseline value (assessed up to 90 minute after Dextrose ingestion).
Oldest-old Patients Anesthesia in Orthopedic Surgeries
NCT Number: NCT06522178
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Anesthesia
Interventions: OTHER: Patient' ages
Sponsor: Istanbul Medeniyet University
Sex: ALL
Age: OLDER_ADULT
Enrollment: 1356
Study Design: Observational Model: |Time Perspective: p
Start Date: 2016-01-03
Completion Date: 2024-01-01
Locations: Istanbul Medeniyet University, İ̇stanbul, 34730, Turkey

Summary:
Average life span, life expectancy, and the number of older people, aged 65 years and over, have increased during the last decades. As life expectancy increased, the rate of emergency and elective surgical interventions has also increased in the older age group. Although good health is required to reach an advanced age, over time, organ functions may deteriorate, and some challenges may develop that will negatively affect the balance of homeostasis. Stress, such as trauma or surgery, can cause deterioration in organ functions or aggravation of impaired functions. The risk of developing undesirable events is higher, due to the diminished reserve and function, during anesthesia applied to these patients. There is a limited number of studies in the literature about the relation between the anesthesia technique and morbidity and mortality in oldest old patients operated for orthopedic surgery. In this study, we aimed to analyze the data of the oldest-old patients operated on for orthopedic surgery between 2016-2022, retrospectively, and to investigate the relationship between anesthesia technique and adverse effects including morbidity and mortality.

Primary Outcome Measures: Mortality, postoperative mortality, one month after operation|Anesthesia Techniques, Data were also analyzed and compared with groups and between groups according to the applied anesthesia technique (general anesthesia versus regional anesthesia)., up to 6 hours|Type of operation, Orthopedic surgery type, up to 6 hours
Secondary Outcome Measures: Presence and type of comorbidities, Hypertension, dementia, asthma, COPD (Chronic obstructive pulmonary disease), CHF (Chronic Heart Failure), CAD (Coronary artery disease), DM (Diabetes mellitus), valvular heart disease, history of pulmonary emboli, electrolyte imbalance, presence of cancer, renal diseases, history of cerebrovascular disease, endocrine diseases, neurologic diseases, other chronic diseases, 6 month period before operation
PEDIATRIC ONCOLOGICAL ORTHOPAEDIC RECONSTRUCTIONS
NCT Number: NCT06522165
Status: ACTIVE_NOT_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Bone Tumor|Bone Cancer
Interventions: OTHER: Analysis
Sponsor: Costantino Errani
Sex: ALL
Age: CHILD
Enrollment: 400
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-12-01
Completion Date: 2024-09-30
Locations: IRCCS Itituto Ortopedico Rizzoli, Bologna, BO, 40136, Italy

Summary:
From the archives of the Rizzoli institute all the children undergoing oncological reconstruction from 1991 to 2023 (approximately 400 patients). A review will be made of the medical records, radiological imaging, and histological data of these patients

Primary Outcome Measures: longevity of the reconstruction, -assess the longevity and the complications associated with pediatric oncologic reconstructions, at baseline (day 0)
Clinical Outcome After Episealer Talus Implant in Treatment of Osteochondral Lesion of the Talus
NCT Number: NCT06522139
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Osteochondral Defect
Interventions: PROCEDURE: Implantation of Episealer Talus Implant
Sponsor: Stefano Zaffagnini
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2021-10-14
Completion Date: 2027-08
Locations: IRCCS Istituto Ortopedico Rizzoli, Bologna, 40136, Italy

Summary:
Autologous Chondrocyte Implantation (ACI) is an appealing technique whereby cartilage is harvested from the joint in a first operation. This biopsy is processed, individual cells are freed and cultivated and, in a second procedure, injected into the defect that has been covered by a periosteal graft). A second generation includes a matrix (MACI) into which the cells are injected/cultivated. Recently, collagen membranes are used to cover the cells or cover a micro-fractured defect. Good results have been reported although return to previous sports remains a challenge . Long term results are lacking. More important is the fact that these treatments are directed towards restoring the articular cartilage whereas the patient's symptoms are generated by the bone and not the cartilage.

Treatment of an OCD with a small metallic implant has been tested in recent years. Results have been promising by some reports, while a high revision rates was reported by others. A recent 2-8 years follow-up study revealed a survival rate of 95 %

Primary Outcome Measures: FOOT AND ANKLE OUTCOME SCORE -symptoms, The FAOS (Foot and Ankle outcome score) is a 42-item questionnaire, 7 items for symptoms, after 12 months from the intervention|Implant survival, Implant survival rate at 60 months follow-up, after 5 years|FOOT AND ANKLE OUTCOME SCORE - pain, The FAOS (Foot and Ankle outcome score) is a 42-item questionnaire, 9 for pain, after 12 months from the intervention|FOOT AND ANKLE OUTCOME SCORE -symptoms, The FAOS (Foot and Ankle outcome score) is a 42-item questionnaire, 7 items for symptoms, after 24 months from the intervention|FOOT AND ANKLE OUTCOME SCORE - Pain, The FAOS (Foot and Ankle outcome score) is a 42-item questionnaire, 9 for pain, after 24 months from the intervention
The Effects of Progressive Relaxation Exercise
NCT Number: NCT06522126
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Effects of Progressive Relaxation Exercise|Exercise|Relation, Interpersonal
Interventions: BEHAVIORAL: progressive relaxation exercise
Sponsor: Inonu University
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 162
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2022-09-01
Completion Date: 2024-05-02
Locations: Esra Sabanci Baransel, Malatya, Turkey

Summary:
Aim: This research was conducted to determine the effects of progressive relaxation exercise on life satisfaction, anxiety, and psychological well-being in people experiencing premenstrual syndrome.

Methods: This randomized controlled trial was conducted with students who were enrolled in a university in the east of Türkiye, studying at the undergraduate levels outside the field of health, and experiencing premenstrual syndrome. The sample of the research consisted of 162 students (Exercise group 81 participants; Control group 81 participants). The Personal Information Form, Premenstrual Syndrome Scale (PMSS), Life Satisfaction Scale (LSS), Beck Anxiety Scale (BAS), and Psychological Well-Being Scale (PWBS) were used to collect data. Women in the exercise group underwent eight sessions of relaxation exercises, once a week for 8 weeks. In addition, for eight weeks after the first exercise, the participants exercised at home, at least twice a week, outside of the training. The PMSS, LSS, BAS, and PWBS were applied as post-tests to the participants in both groups, 8 weeks after the pre-tests.

Primary Outcome Measures: Premenstrual Syndrome Scale (PMSS), It is a 44-item Likert-type scale developed by Gençdoğan (2006) that measures the severity of premenstrual symptoms. The scale has nine subscales, and the "PMSS total score" consisting of the scores related to the subscales and the total of the scale is obtained. The application of PMSS is done by retrospectively evaluating the person's status "one week before menstruation". The lowest score that can be obtained from the scale is 44 and the highest score is 220. The higher the score, the more intense the premenstrual syndrome symptoms are considered. The highest score that can be obtained for the total score is 220, 50% of which is 110 points. Therefore, those who score 111 and higher have PMS in terms of total score., 8 weeks
Secondary Outcome Measures: Life Satisfaction Scale (LSS), The scale was developed by Diener et al. Cronbach's alpha reliability coefficient of the scale was determined, 8 weeks
Other Outcome Measures: Beck Anxiety Scale (BAS), The scale was developed by Beck et al. to determine the incidence of anxiety and anxiety symptoms experienced by individuals. The scoring of the measurement, which consists of 21 items, varies between 0-3. The scale was adapted into Turkish by Ulusoy et al. As a result of studies conducted with individuals presenting with psychological complaints, 8 weeks
Cilostazol and Aspirin in Stroke and TIA
NCT Number: NCT06522113
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Ischemic Stroke|TIA
Interventions: DRUG: Cilostazol|DRUG: Clopidogrel
Sponsor: Incheon St.Mary's Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 378
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2019-07-18
Completion Date: 2022-10-17
Locations: The Catholic university of korea, Incheon St. Mary's hospital, Incheon, Korea, Republic of

Summary:
This study is a randomized, open-labelled trial. We randomly assigned patients within 24 hours after the onset of minor ischemic stroke or high-risk TIA to combination therapy with cilostazol and aspirin or to clopidogrel plus aspirin. The primary outcome was stroke (ischemic or hemorrhagic) during 90 days of follow-up in an intention-to-treat analysis.

Primary Outcome Measures: New stroke event for 90 days (Ischemic or hemorrhagic), New stroke event for 90 days (Ischemic or hemorrhagic), for 90 days|Moderate-to-severe bleeding event according to (GUSTO) definition, Moderate-to-severe bleeding event according to (GUSTO) definition:

Moderate : bleeding requiring transfusion Severe : Fatal or intracerebral bleeding, or bleeding resulting in substantial hemodynamic compromise requiring treatment, for 90 days
Secondary Outcome Measures: New clinical vascular event (ischemic or hemorrhagic stroke, myocardial infarction, or vascular death), analyzed as a composite outcome and also as individual outcomes., New clinical vascular event (ischemic or hemorrhagic stroke, myocardial infarction, or vascular death), analyzed as a composite outcome and also as individual outcomes. Vascular death was defined as death due to stroke (ischemic or hemorrhagic), systemic hemorrhage, myocardial infarction, congestive heart failure, pulmonary embolism, sudden death, or arrhythmia., for 90 days
Corticoid Therapy in Acute Myocarditis
NCT Number: NCT06522100
Acronym: COTAM
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Acute Myocarditis
Interventions: DRUG: Intravenous administration of Methylprednisolone|DRUG: Oral Prednisone|DRUG: Perfusion of placebo|DRUG: Oral Prednisone placebo
Sponsor: Assistance Publique - Hôpitaux de Paris
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 420
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2025-02-01
Completion Date: 2028-08-16

Summary:
Refer to the "Detailed Description" section.

Primary Outcome Measures: Efficacy of treatments, Major Cardiovascular Events (MACE) and/or persistence of left ventricular dysfunction defined as LVEF \< 50% and/or Global Longitudinal Strain (GLS) \< - 16%. MACE is a combined criterion that includes all-cause mortality, heart failure hospitalization, sustained ventricular arrhythmia, heart transplantation or assistance and recurrent acute myocarditis with LV dysfunction., 6 months
Secondary Outcome Measures: Changes in LVEF ≥ 50%, Changes in LVEF ≥ 50% at 6 months using 2D trans-thoracic echocardiography (2D-TTE), 6 months|Global Longitudinal Strain (GLS) ≥ -16%, Changes in Global Longitudinal Strain (GLS) ≥ -16% at 6 months using 2D-TTE, 6 months|All-cause mortality, Occurred of a death, 6 months|Heart failure hospitalization, Occurred of hospitalization for heart failure, 6 months|Sustained ventricular arrhythmia, Occurred of sustained ventricular arrhythmia, 6 months|Heart transplantation, Occurred of heart transplantation, 6 months|Heart assistance by extracorporeal membrane oxygenation (ECMO), Intra-aortic balloon pump (IABP), Impella® device or Left Ventricular Assistance Devices (LVAD), Need for heart assistance by extracorporeal membrane oxygenation (ECMO), Intra-aortic balloon pump (IABP), Impella® device or Left Ventricular Assistance Devices (LVAD), 6 months|Recurrence of acute myocarditis with LV dysfunction, Time to recurrence of acute myocarditis with LV dysfunction, 6 months|Safety of the treatment regimens, Adverse events and serious adverse events, 6 months|Adherence to the treatment regimen, Compliance to the treatment (premature ending of the treatment or proportion of non-administered doses of the treatment), 6 months|Evaluate quality of life using Minnesota living with heart failure questionnaire (MLHFQ), Increased quality of life evaluated by Minnesota living with heart failure questionnaire during follow up. 21 questions rated from 0 to 5. Overall score from 0 to 105. The score increase with the adverse impact of heart failure., 6 months
The Effect of 40 Hz Transcranial Stimulation on the Incidence of Delirium After Total Hip Replacement or Total Knee Replacement Arthroplasty in Elderly Patients.
NCT Number: NCT06522087
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Postoperative Delirium|Anesthesia|Elderly
Interventions: DEVICE: 40Hz stimulation
Sponsor: Henan Provincial People's Hospital
Sex: ALL
Age: OLDER_ADULT
Enrollment: 110
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-05-01
Completion Date: 2025-03-15
Locations: Henan People's Hospital, Zhengzhou, Henan, China

Summary:
Delirium is an acute confusional state, it is a sign of acute encephalopathy, also known as acute brain failure, acute brain dysfunction or mental state changes.Postoperative delirium can cause post-traumatic stress disorder, affects patients' quality of life, extend the length of hospital stay, increased hospitalization cost, and is closely relative to short-term and long-term mortality after surgery. Exogenous 40 Hz stimulation can improve cognitive functioning. Therefore, the aim of this study was to investigate the effect of exogenous 40Hz stimulation on the incidence of postoperative delirium in elderly patients undergoing hip and knee replacement.

Primary Outcome Measures: The incidence of postoperative delirium, Postoperative delirium was assessed by CAM scale.The diagnosis of delirium mainly depends on four characteristics: 1 acute fluctuating course; 2 attention disorder; 3 thinking disorder; 4 change of consciousness level. At the same time, 1 and 2, and 3 or 4 can be used to diagnose delirium., Day 1, Day 2, Day 3 after surgery
Secondary Outcome Measures: Blood Markers, Serum Tau proteomic analysis and CRP, IL-6, and B cell levels were recorded, Preoperative and postoperative 1 d and 2 d|The incidence of postoperative nausea and vomiting, Follow up patients for nausea and vomiting, Day 1, Day 2, Day 3 after surgery|Sleep quality, Sleep quality was assessed using a sleep quality scale(QS),(0: no effect on sleep 1: sleep in and out of sleep at night 2: sleep in and out of sleep unable to fall asleep 3: light sleep but unable to fall asleep 4: unable to fall asleep at all), Day 1, day 2, day 3 after surgery|The incidence of pain, NRS is a dotted ruler from 0 to 10. 0 means no pain, and 10 means unbearable pain. The patient chooses a number from above to describe the pain., Day 1, day 2, day 3 after surgery
Evaluating the Role of IGF-1 and S-Klotho in Plaque Phenotype
NCT Number: NCT06522074
Acronym: VISION
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Ischemic Heart Disease|Chronic Coronary Syndrome
Interventions: DIAGNOSTIC_TEST: Coronarography with OCT
Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-15
Completion Date: 2026-12-31
Locations: Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC Cardiologia, Roma, 00168, Italy

Summary:
Background:Insulin-like growth factor 1 (IGF-1) is the primary peripheral mediator of growth hormone (GH) and has pleiotropic effects on development, differentiation, metabolism, and cell survival. Several in vivo and in vitro studies suggest that IGF-1 may have a protective effect on atherosclerosis as it suppresses macrophage recruitment and activation, cytokine production, and extracellular matrix degradation while promoting smooth muscle cell migration and proliferation and extracellular matrix deposition. The protein sKlotho appears to be closely related to the GH-IGF-1 axis, and some animal and in vitro studies hypothesize its protective role in the cardiovascular system. Hypothesis: The GH-IGF-1 axis and sKlotho influence mechanisms determining coronary atherosclerosis. Circulating levels of IGF-1 and sKlotho may correlate with the morphology of atherosclerotic plaques and particularly with the vulnerability of coronary lesions.

Objectives: To evaluate the correlation between atherosclerotic plaque phenotype and the GH-IGF-

1 axis and sKlotho in patients with chronic coronary syndrome using intravascular imaging with Optical Coherence Tomography (OCT). Methods:All patients with chronic coronary syndrome who meet the inclusion and exclusion criteria and undergo coronary angiography and intravascular imaging with optical coherence tomography will be included. At the end of the procedure, a blood sample will be taken to measure IGF-1, sKlotho, and GH receptor (GHR) polymorphism.

Primary Outcome Measures: correlation between atherosclerotic plaque phenotype and plasma levels of IGF-1, sKlotho protein, and GH receptor (GHR), To assess the correlation between atherosclerotic plaque phenotype and plasma levels of IGF-1, sKlotho protein, and GH receptor (GHR) gene expression through intravascular imaging with Optical Coherence Tomography (OCT)., 2 years
Secondary Outcome Measures: correlation between atherosclerotic plaque phenotype and plasma levels of other hormones and inflammation markers, To assess the correlation between atherosclerotic plaque phenotype and plasma levels of thyroid-stimulating hormone (TSH), triiodothyronine (FT3), thyroxine (FT4), cortisol, adrenocorticotropic hormone (ACTH), follicle-stimulating hormone (FSH), luteinizing hormone (LH), estradiol, testosterone, inflammation markers (interleukin 6, C-reactive protein), vitamin D, and FGF-23 (fibroblast growth factor)., 2 years
SJS/TEN or Other Cutaneous Adverse Eevents Induced by Immune Checkpoint Inhibitors (ICIs) vs. Non-ICIs
NCT Number: NCT06522048
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Immune Checkpoint Inhibitor-Induced Dermatitis|Stevens-Johnson Syndrome, Drug-Induced|Toxic Epidermal Necrolysis Due to Drug
Interventions: OTHER: Observational studies do not require intervention
Sponsor: Chao Ji
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 300
Study Design: Observational Model: |Time Perspective: p
Start Date: 2015-01
Completion Date: 2024-05
Locations: First Affiliated Hospital of Fujian Medical University, Fuzhou, Fujian, 350000, China

Summary:
Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis (SJS/TEN) is a severe adverse drug reaction, characterized by extensive skin detachment. With the increasing use of immune checkpoint inhibitors (ICIs) in oncology, it is crucial to understand the differences in SJS/TEN induced by ICIs compared to other drugs. This study aims to compare the clinical manifestations and outcomes of Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis (SJS/TEN) or other severity of cutaneous adverse events induced by immune checkpoint inhibitors (ICIs), versus other types of drugs. We analyzed differences in clinical characteristics, treatment methods, outcomes, and survival time and quality of life.

Primary Outcome Measures: Analysis of Clinical Features of Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis Induced by Immune Checkpoint Inhibitors Versus Non-Immune Checkpoint Inhibitors Medications, Present the analysis results, highlighting significant differences between the two groups. Use tables and graphs to illustrate key findings., January 2015 to May 2024
Evaluation of Allocetra by Intra-articular Injection for the Treatment of Psoriatic Arthritis
NCT Number: NCT06522035
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Arthritis, Psoriatic
Interventions: DRUG: Allocetra
Sponsor: Enlivex Therapeutics Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 6
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2026-01
Locations: Tel Aviv Sourasky Medical Center - Ichilov, Tel Aviv, 6423906, Israel

Summary:
This is an open label study to evaluate the safety and initial efficacy of intra-articular administration of Allocetra in patients with Psoriatic Arthritis (PsA).

Primary Outcome Measures: Primary outcome, Number and severity of AEs, SAEs and injection reactions following treatment, 12 months
Secondary Outcome Measures: Patient reported pain Numeric Rating Scale (NRS) in the target joint., Evaluation of change from baseline in patient reported pain Numeric Rating Scale (NRS) in the target joint., 3 months, 6 months and 12 months.
Other Outcome Measures: Exploratory outcome- assessment of change from baseline in Psoriasis Area and Severity Index (PASI)., 12 months|Exploratory outcome- assessment of change from baseline in Disease Activity in Psoriatic Arthritis (DAPSA) score., 12 months