pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
A Study Evaluating Food Effect on Pharmacokinetics of HS-10518
NCT Number: NCT06554548
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Endometriosis
Interventions: DRUG: HS-10518
Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 8
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-15
Completion Date: 2025-08-30

Summary:
The primary objective of this study is to evaluate the effect of food on the pharmacokinetics of HS-10518

Primary Outcome Measures: Peak plasma concentration (Cmax) of HS-10518, predose and within 48 hours postdose in each treatment period|Area under the plasma concentration versus time curve (AUC0-t) of HS-10518, within 48 hours postdose in each treatment period, within 48 hours postdose in each treatment period
Efficacy and Safety of Serplulimab With Chemotherapy and Aspirin in Untreated Extensive-Stage Small Cell Lung Cancer
NCT Number: NCT06554535
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Extensive-Stage Small Cell Lung Cancer|Treatment-naïve for Systemic Therapy Targeting Extensive-Stage Small Cell Lung Cancer|ECOG Performance Status Score of 0 or 1|Expected Survival ≥3 Months
Interventions: DRUG: Serplulimab，Platinum-based Chemotherapy，Aspirin
Sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 43
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-10-01
Completion Date: 2027-10-01

Summary:
Lung cancer remains a leading cause of cancer-related deaths worldwide, with small cell lung cancer (SCLC) accounting for 15-20% of all lung cancers. Extensive-stage SCLC (ES-SCLC) is associated with poor prognosis, with a median survival of 2-4 months without treatment. Although platinum-based chemotherapy is the standard first-line treatment, median survival remains under one year, highlighting the need for improved outcomes. Recent studies have demonstrated that combining PD-1 inhibitors with chemotherapy can significantly improve survival in ES-SCLC patients. Serplulimab, a novel PD-1 inhibitor, has shown promising results in extending overall survival when combined with chemotherapy in a Phase III trial. Additionally, aspirin has been found to enhance the anti-tumor effects of immunotherapy by inhibiting immune checkpoint proteins and reducing adverse events such as thrombosis and fever. This Phase II study aims to evaluate the efficacy and safety of combining serplulimab, platinum-based chemotherapy, and aspirin as a first-line treatment for patients with ES-SCLC.

Primary Outcome Measures: Progression-Free Survival, The time from the start of treatment until the first documented disease progression or death from any cause, whichever occurs first, as assessed by RECIST criteria (Response Evaluation Criteria in Solid Tumors)., Up to 2 years
Secondary Outcome Measures: Two-Year Overall Survival, The proportion of patients still alive two years after the start of treatment., 2 years|Objective Response Rate, The proportion of patients with a measurable reduction in tumor size as per RECIST criteria, including complete and partial responses., Up to 2 years|Disease Control Rate, The proportion of patients who achieve complete response (CR), partial response (PR), or stable disease (SD) as per RECIST criteria., Up to 2 years|Incidence of Adverse Events, The number and severity of adverse events, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0., Up to 2 years
Pragmatic Evaluation of Respiratory Distress Syndrome Treatment in Africa
NCT Number: NCT06554522
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Respiratory Distress Syndrome in Premature Infant|RDS of Prematurity|Surfactant Deficiency Syndrome Neonatal|Premature Birth
Interventions: DRUG: Surfactant
Sponsor: Indiana University
Collaborators: Open Philanthropy
Sex: ALL
Age: CHILD
Enrollment: 1512
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-10-01
Completion Date: 2027-12-30
Locations: Centre Hospitalier Universitaire Communautaire, Bangui, Central African Republic|Complexe Hospitalier Universitaire Pédiatrique de Bangui, Bangui, Central African Republic|Korle-Bu Teaching Hospital, Accra, Ghana|Komfo Anokye Teaching Hospital, Kumasi, Ghana|Kilifi County Hospital, Kilifi, Kenya|Mama Lucy Kibaki Hospital, Nairobi, Kenya|Federal Teaching Hospital Ido-Ekiti, Ido-Ekiti, Ekiti, Nigeria|University of Ilorin Teaching Hospital, Ilorin, Kwara, Nigeria

Summary:
The goal of this pragmatic clinical trial is to learn if the drug surfactant given by a less invasive technique works to treat respiratory distress in preterm infants in low- and middle-income African countries where invasive ventilators are unavailable. It will also learn about the safety of the less invasive surfactant administration (LISA) technique. The main questions it aims to answer are:

Does surfactant given by a less invasive surfactant administration technique improve survival in preterm infants in low- and middle-income countries? What medical problems do participants have when receiving surfactant given by the less invasive surfactant administration technique?

Researchers will implement the less invasive surfactant administration technique and see if it works to treat respiratory distress in preterm infants compared to preterm who did not receive surfactant.

Participants with respiratory distress who are being treated with continuous positive airway pressure and caffeine citrate will:

Receive surfactant replacement therapy by the less invasive surfactant administration technique.

Be monitored for complications Be followed throughout their hospitalization to determine their survival rate.

Primary Outcome Measures: Hospital Survival, Survival to hospital discharge, Through hospitalization, an average of 6 months
Secondary Outcome Measures: Incidence of major preterm neonatal morbidity, Intraventricular hemorrhage, Retinopathy of Prematurity, Bronchopulmonary Dysplasia, Surgical Necrotizing Enterocolitis and Culture Positive Sepsis, Through hospitalization, an average of 6 months|The incidence of pneumothorax, Air leaks into the space between your lung and chest wall, Through hospitalization, an average of 6 months|Hospital survival at seven day, Survival rates assessed at day seven of life, 7 days following birth
Local vs Systemic Methotrexate in Management of Uterine Ectopic Pregnancy
NCT Number: NCT06554470
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Local|Systemic|Methotrexate|Uterine Ectopic Pregnancy
Interventions: DRUG: Systemic Methotrexate|DRUG: Local Methotrexate
Sponsor: Tanta University
Sex: FEMALE
Age: ADULT
Enrollment: 34
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-15
Completion Date: 2025-07-01
Locations: Tanta University, Tanta, El-Gharbia, 31527, Egypt

Summary:
This study aims to compare local and systemic methotrexate in the management of uterine ectopic pregnancy regarding the duration of beta human chorionic gonadotropin (hCG) clearance and need for further management options.

Primary Outcome Measures: Time for serum b-hCG remission, Time for serum b-hCG remission will be recorded to be less than 20 iu/ml., Post intervention for 3 months
Secondary Outcome Measures: Success rate, Success rate will be recorded., Post intervention for 3 months|Time for uterine-mass disappearance, Time for uterine-mass disappearance will be recorded., Post intervention for 3 months|Hospitalization time, Hospitalization time will be recorded from admission till discharge from hospital., 15 days after intervention
Post Surgical Multimodal Analgesia With Oral Strong Opioids
NCT Number: NCT06554457
Acronym: ORORA
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Orthopedic Procedures|Arthroplasty|Fracture Fixation
Interventions: DRUG: Multimodal analgesia with oral strong opioids
Sponsor: Tri-Service General Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-12
Completion Date: 2025-07-31
Locations: TriService General Hospital, Taipei, 114, Taiwan

Summary:
This is a prospective observational case study, focusing on the clinical effectiveness of oral strong opioids for pain management following common orthopedic surgeries.The study aims to evaluate the effectiveness of multimodal analgesia with oral strong opioids, reduce common opioid-related side effects, and improve patient compliance and satisfaction.

Primary Outcome Measures: Change in pain scores from baseline, Assess the efficacy of including oral strong opioids in multimodal pain control. For this objective, we will observe changes in pain scores among participants during postoperative treatment., Twice daily during hospitalization (approximately within 1 week), at the first return 1 day visit and at 3 months after surgery
Secondary Outcome Measures: Occurence of adverse events, Avoid common adverse reactions associated with traditional morphine-like drugs, such as respiratory depression and addiction, to enhance treatment safety and patient comfort. We will monitor the occurrence rate of adverse reactions related to oral potent opioids., During hospitalization (approximately within 1 week)|Compliance of oral strong opioids, Improvement the convenience of analgesic medication by transitioning from injections to oral administration, making it easier for patients to accept and adhere to the treatment plan. The compliance rate of oral strong opioids will be measured., During hospitalization (approximately within 1 week)|Physician's global impression - improvement scale(CGI-I), Effectiveness of the pain control will be assessed by a 7-point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. Scale 1= Very much improved and scale 7 = very much worse, During hospitalization (approximately within 1 week), at the first return 1 day visit and at 3 months after surgery|Satisfation of the pain control as per patients' report outcome, Enhance patient acceptance of the treatment by using oral administration, boosting confidence in the treatment plan and increasing adherence and effectiveness. Patient satisfaction and pain improvement will be assessed through a 5-point scale questionnaire. 1=very much discontent, 2=discontent, 3=fair, 4=satisfied, 5=very much satisfied., End of hospitalization (approximately 1 week after surgery)
Assessment of Early Healing Period of Dental Implants
NCT Number: NCT06554444
Status: ENROLLING_BY_INVITATION
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Dental Implant|Osseointegration|Biological Width
Interventions: PROCEDURE: Dental Implant Surgery
Sponsor: Kutahya Health Sciences University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SCREENING
Start Date: 2024-09-02
Completion Date: 2026-09-02
Locations: Kutahya Health Sciences University, Kutahya, 43020, Turkey

Summary:
This prospective cohort study aimed to evaluate, clinically, radiographically, and digitally, the volumetric changes occurring during the early healing period after implant treatment in patients with tooth loss in the posterior regions of the jaws, focusing on the processes of osseointegration and biological width formation.

Primary Outcome Measures: Linear changes in the tissue, Linear changes in the tissue resulting from the alignment of scan data obtained at four different time points., Preoperative and postoperative 2nd, 4th, and 12th months
Secondary Outcome Measures: Keratinized mucosa width (from the edentulous ridge), Keratinized tissue measured from the mid-buccal of the edentulous area using a periodontal probe., Preoperative and postoperative 2nd month|Keratinized mucosa width (from the gingival margin of the dental implant-supported prosthesis), Keratinized tissue measured from the gingival margin of the dental implant-supported prosthesis to the mucogingival junction using a periodontal probe., Postoperative 4th and 12th months|Mucosal thickness (from the edentulous ridge), Mucosal thickness measured from the midpoint of the edentulous area using a periodontal probe., Preoperative and postoperative 2nd month|Mucosal thickness (from the facial aspect of the edentulous ridge), Mucosal thickness measured at the mid-buccal of the edentulous area, from the midpoint between the mucogingival junction and 2 mm apical to the gingival margin of the adjacent tooth, using a endodontic spreader., Preoperative and postoperative 2nd month|Mucosal thickness (from 3 mm apical to the gingival margin of the implant-supported prosthesis), Mucosal thickness measured 3 mm apical to the gingival margin of the implant-supported prosthesis using a endodontic spreader., Postoperative 4th and 12th months|Peri-implant pocket depth, Peri-implant pocket depth measured at six points around the dental implant using a periodontal probe., Postoperative 4th and 12th months|Modified plaque index, Modified plaque index measured at four points around the dental implant using a periodontal probe., Postoperative 4th and 12th months|Modified bleeding index, Modified bleeding index measured at four points around the dental implant using a periodontal probe., Postoperative 4th and 12th months|Marginal bone level, Marginal bone level measured on periapical radiographs., Preoperative and postoperative 2nd, 4th, and 12th months
Identification of Serum Level of Glutathione Peroxidase 4
NCT Number: NCT06554392
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Spondyloarthropathy
Interventions: DIAGNOSTIC_TEST: Blood sample
Sponsor: Assiut University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 85
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-01
Completion Date: 2027-07-01

Summary:
* Analysis of the level of glutathione peroxidase 4 (GPX4) in ankylosing spondylitis and axial psoriatic arthritis patients.
* The association of glutathione peroxidase 4 (GPX4) with disease activity and severity in ankylosing spondylitis and axial psoriatic arthritis patients.

Primary Outcome Measures: Analysis of the serum level of glutathione peroxidase 4 (GPX4) in ankylosing spondylitis and axial psoriatic arthritis patients., Analysis of the serum level of glutathione peroxidase 4 (GPX4) in ankylosing spondylitis and axial psoriatic arthritis patients to detect ferroptosis process in those patients., baseline
Secondary Outcome Measures: The association of glutathione peroxidase 4 (GPX4) with disease activity and severity in ankylosing spondylitis and axial psoriatic arthritis patients., The association of glutathione peroxidase 4 (GPX4) with disease activity and severity in ankylosing spondylitis and axial psoriatic arthritis patients., baseline
Bacterial Load Reduction by GentleWave and EdgePro Irrigation Systems in Mandibular Necrotic Molars
NCT Number: NCT06554366
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Pulp Necroses
Interventions: DEVICE: GentleWave|DEVICE: EdgePro laser irrigation|DEVICE: Irrisafe passive ultrasonic irrigation
Sponsor: The University of Texas Health Science Center, Houston
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-13
Completion Date: 2025-06-30
Locations: The University of Texas Health Science Center at Houston, Houston, Texas, 77030, United States

Summary:
The purpose of this study is to compare the efficacy of GentleWave versus EdgePro irrigation in the disinfection of infected root canals of human permanent teeth with necrotic pulp.

Primary Outcome Measures: Bacterial count reduction checked by 16 S rDNA next-generation sequencing analysis (NGS), Baseline, after cleaning and shaping of the root canal (about 30 minutes after baseline)
Secondary Outcome Measures: Presence of proteolytic versus non-proteolytic bacteria in the root canals, Baseline, after cleaning and shaping of the root canal (about 30 minutes after baseline)
Cardiopulmonary Exercise Testing and Oscillometry for the Evaluation of Dyspnea
NCT Number: NCT06554353
Acronym: COED
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Breathing, Mouth|Lung Function Decreased|Dyspnea|Shortness of Breath
Interventions: DEVICE: Oscillometer
Sponsor: University of Rochester
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-01
Completion Date: 2026-06-30

Summary:
This study will determine if airway resistance to airflow and pressure, measured by Oscillometry, is associated with abnormal findings on Cardiopulmonary Exercise Testing in subjects who are experiencing shortness of breath.

Primary Outcome Measures: Mean respiratory system resistance and reactance, The oscillometer will collect an airway impedance measurement which is made up of multiple variables., Single measurement, approximately day 1
Ventilator Associated Pneumonia Multiplex PCR for Anti-Infective Regimens
NCT Number: NCT06554327
Acronym: VAMPAIR
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Ventilator Associated Pneumonia
Interventions: DEVICE: Multiplex PCR
Sponsor: CHU de Reims
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 265
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-09
Completion Date: 2026-03
Locations: Damien JOLLY, Reims, France

Summary:
Ventilator-associated pneumonia (VAP) remains one of the main nosocomial infections acquired in the intensive care unit (ICU). VAP is pneumonia occurring 48 hours after intubation. Today, bronchoalveolar lavage (BAL) is used for microbiological diagnosis, with bacterial culture and antibiotic susceptibility results within 48 to 72 hours. Multiplex PCR can detect DNA of a number of bacteriae, as well as the presence of resistance genes. However, its clinical value in the ICU remains to be demonstrated. We think that the use of multiplex PCR with a panel adapted to the microbiology of VAP, could be an interesting method for clinicians in ICU.

Primary Outcome Measures: The percentage of appropriate empirical antibiotic therapy in cases of culture-confirmed VAP, according to the diagnostic method used (multiplex PCR or not)., The appropriate antibiotic is one that is effective against the diagnosed pathogen and has the narrowest possible antibiotic spectrum., Day 14
Secondary Outcome Measures: The percentage of effective antibiotic treatment for the identified germ in each group., The effective antibiotic is one that is effective against the diagnosed pathogen., Day 14|Duration of inappropriate antibiotic therapy (in hours) in each group, An inappropriate antibiotic is one that is not active according to the in vitro antibiogram of the identified pathogen, or whose spectrum is too broad for the resistance profile of the identified pathogen., Day 14
Effect of Probiotics on Regulating Gut Health and Blood Lipid in Adults
NCT Number: NCT06554314
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Obesity
Interventions: DIETARY_SUPPLEMENT: probiotics
Sponsor: Chung Shan Medical University
Collaborators: Nutrarex Biotech Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, CARE_PROVIDER)|Primary Purpose: PREVENTION
Start Date: 2024-05-17
Completion Date: 2025-05-31
Locations: Chung Shan Medical University, Taichung, South, 402, Taiwan

Summary:
The purpose of this study was to evaluate the efficacy of 1 capsules (300 mg per capsule) of Nutrarex Probiotic Capsules per day in regulating gut health and blood lipid in adults by clinical trial.

Primary Outcome Measures: Change from baseline serum lipids at week 4, Compared the difference of serum lipids level between the week 4 and 0, Week0, Week4
A Study on the Efficacy and Safety of Empagliflozin in the Treatment of Pulmonary Arterial Hypertension
NCT Number: NCT06554301
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Pulmonary Arterial Hypertension
Interventions: DRUG: empagliflozin in treatment pulmonary aerterial hypertension|DRUG: placebo in treatment pulmonary aerterial hypertension
Sponsor: China National Center for Cardiovascular Diseases
Collaborators: The Second Hospital of Shandong University|The First People's Hospital of Changzhou
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 72
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2026-12
Locations: Fuwai Hospital, Chinese Academy of Medical Sciences, Beijing, Beijing, 100037, China

Summary:
The goal of this clinical trial is to learn if empagliflozin works to treat patients with pulmonary arterial hypertension. It will also learn about the safety of empagliflozin. The main questions it aims to answer are:

Based on standard treatment, does empagliflozin reduce pulmonary artery pressure and improve cardiac function in patients with pulmonary arterial hypertension? What medical problems do participants have when taking empagliflozin? Researchers will compare empagliflozin to a placebo (a look-alike substance that contains no drug) to see if empagliflozin works to treat patients with pulmonary arterial hypertension.

Participants will:

Take empagliflozin or a placebo every day for 12 weeks Visit the clinic once every 4 weeks for checkups and tests Keep a diary of their symptoms and the drug taking situation

Primary Outcome Measures: 6-minute walking distance, From enrollment to the end of treatment at 12 weeks
Secondary Outcome Measures: Clinical deterioration event, From enrollment to the end of treatment at 12 weeks|Cardiac function index(NT-proBNP, WHO functional classification), From enrollment to the end of treatment at 12 weeks|Hemodynamic index, From enrollment to the end of treatment at 12 weeks|Health-related quality of life (HRQoL) index, From enrollment to the end of treatment at 12 weeks|Cardiac magnetic resonance (CMR), From enrollment to the end of treatment at 12 weeks
CCHS Secure Health-hub Advancing Research Efforts (CCHS SHARE)
NCT Number: NCT06554275
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Congenital Central Hypoventilation Syndrome
Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago
Collaborators: Assistance Publique - Hôpitaux de Paris (AP-HP) : Hôpital de la Pitié-Salpêtrière|Great Ormond Street Hospital-London (GOSH)|Assistance Publique - Hôpitaux de Paris (AP-HP) : Hôpital universitaire Robert Debré
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 175
Study Design: Observational Model: |Time Perspective: p
Start Date: 2025-02-01
Completion Date: 2028-08-31

Summary:
The purpose of this study is to capture longitudinal natural history data in Congenital Central Hypoventilation Syndrome (CCHS). This will include capturing standardized clinical data from standard of care assessments at several CCHS referral centers.

Primary Outcome Measures: Patient Quality of Life, Patient reported outcome common data elements reflecting core aspects of CCHS will be captured using the Pediatric Quality of Life Inventory (PedsQL) and the 36-item Short Form Health Survey (SF-36), Up to every 14 months|Caregiver Burden, Caregiver burden will be assessed using the Zarit Burden Interview, Up to every 14 months|Patient and Caregiver Sleep, Patient and caregiver sleep will be assessed using PROMIS Sleep Disturbance and Sleep-Related Impairment short forms, Up to every 14 months|Autonomic Symptom Profile, Validated measures of autonomic function will be captured including data elements from COMPASS-31 and a patient-reported clinical and disease-specific outcomes symptomatology questionnaire relating to CCHS., Up to every 14 months|Characterize CCHS from a clinical perspective using standardized common data elements (CDEs) in the clinical setting., CDEs will include key data points from standard of care assessments of respiratory and cardiovascular function, sleep, exercise capacity, neurocognition, and blood labs., Up to every 14 months
Visceral Fat and Cardiometabolic Risk
NCT Number: NCT06554262
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Cardiometabolic Risk|Visceral Fat|Cohort Study
Interventions: OTHER: No intervention
Sponsor: Capital Medical University
Sex: ALL
Age: CHILD, ADULT
Enrollment: 18938
Study Design: Observational Model: |Time Perspective: p
Start Date: 2013-01
Completion Date: 2019-09

Summary:
The present study showed that the 75th percentile of visceral fat area in boys and girls is the optimal cutoff for screening cardiometabolic risk and its clustering, but the 80th percentile is the optimal cutoff for hyperglycemia screening in girls. The investigators proposed simplified cutoffs of 37.19 cm2 and 31.09 cm2 aged 6 to 8 years, 56.76 cm2 and 39.51 cm2 aged 9 to 11 years, 57.03 cm2 and 38.33 cm2 aged 12 to 15 years, and 58.32 cm2 and 53.91 cm2 aged 16 to 18 years for boys and girls, respectively. Both the optimal and simplified methods were verified in a 2-year longitudinal cohort. An improved understanding of the importance of visceral fat to cardiometabolic risk and its clustering in children may yield insight into the risks associated with child obesity and the initial phases of cardiovascular disease development, especially in normal-weight boys.

Primary Outcome Measures: Visceral fat area cutoffs and cardiometabolic risk, Based on dual-energy X-ray measurements of visceral fat area, age- and sex-specific visceral fat area cutoffs for screening cardiometabolic risk was developed and validated., 2 years
Full Bladder IUD Insertion Without Vulsellum Under Ultrasound Guidance
NCT Number: NCT06554249
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Contraceptive Device
Interventions: PROCEDURE: Vulsellum group|PROCEDURE: Ultrasound group
Sponsor: Cairo University
Collaborators: Bedaya Hospital
Sex: FEMALE
Age: ADULT
Enrollment: 82
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-10-15
Completion Date: 2025-06-15
Locations: Faculty of medicine, Cairo university, Cairo, Egypt

Summary:
The aim of this study is to determine whether full bladder IUD insertion without vulsellum or uterine sound under ultrasound guidance is associated with less pain compared with the standard technique of IUD insertion .

Primary Outcome Measures: Intensity of pain, Measured using 100 mm visual analogue scale ( 0 = no pain and 100 = worst possible pain), Immediately after the procedure
Secondary Outcome Measures: Success of IUD insertion, ( number of successfully inserted IUD / total number of IUD insertion attempts), Immediately after the procedure
The Influence of an Orthopaedic Manual Physical Therapy and Sensory Training on Somatoperception in Patients with Chronic Low Back Pain
NCT Number: NCT06554236
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Low Back Pain
Sponsor: Brooke Army Medical Center
Sex: ALL
Age: ADULT
Enrollment: 48
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-31
Completion Date: 2025-06

Summary:
Individuals with chronic low back pain and other chronic pain conditions have been shown to have altered somatosensory, the ability to sense input to the tissue, which is processed in the primary somatosensory cortex or S1. Two-point discrimination is currently the best clinical tool utilized to assess an individual's ability to sense touch. This study will assess TPD changes after a course of standard physical therapy care with the addition of sensory training.

Primary Outcome Measures: Tactile acuity as measured by two-point discrimation, measured using a Caroline 2-point discriminator tool. TPD is the most widely accepted objective measurement of tactile acuity in the clinical setting, Performed at baseline visit, 4th week of treatment, and at final visit (8 +/- 2 weeks).
Secondary Outcome Measures: Pain as measured by numeric pain rating scale, The NPRS is an 11-point numerical pain rating scale used to measure pain. Patients rate pain ranging between 0 (no pain) and 10 (worst pain imaginable), Performed at baseline, 4th week of treatment, and final visit (8 +/- 2 weeks).|Low back perception, measured using the Freemont Back Awareness Questionnaire (FreBAQ), a multi-item, self-report questionnaire designed to quantify distorted perception of the back in people with CLBP, Performed at baseline, 4th week of treatment, and final visit (8 +/- 2 weeks).|Tactile Localization Accuracy, measured by the number of correct responses out of 9 attempts for stimulation of the 9-grid chart, Performed at baseline, 4th week of treatment, and final visit (8 +/- 2 weeks).|Function, measured by the Oswestry Disability Index (ODI), 10 patient-completed questions in which the response options are presented as 6-point Likert scales. Scores range from 0% (no disability) to 100% (most severe disability, Performed at baseline, 4th week of treatment, and final visit (8 +/- 2 weeks).
Epidemiological Study of the Markers of Aging in the Cohort of Patient HIV in Brest
NCT Number: NCT06554210
Acronym: VIHVA
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Aging, Premature|HIV Infections
Sponsor: University Hospital, Brest
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 213
Study Design: Observational Model: |Time Perspective: p
Start Date: 2017-01-08
Completion Date: 2017-12-31
Locations: Internal Medicine Department of University Hospital, Brest, 29200, France

Summary:
RATIONALE: HIV pathology has been associated with accelerated aging of the infected organism, with no known knowledge of virus, immunosuppression, immune response stimulation, antiretroviral toxicity, and "classic" risks. The data are in good standing from a multicenter cohort with high statistical power but very heterogeneous and not exhaustive. A complementary approach by small, comprehensive cohorts is desirable.

POPULATION CONCERNED: HIV-positive persons OBJECTIVE To describe the aging of the physiological functions of people living with HIV.

SECONDARY OBJECTIVES Assess the determinants (virus / HAART / Immunity / environment) Compare to the general population (historical comparisons) Compare to main body functions MAIN EVALUATION CRITERIA respiratory functional tests, memory test, IMTc, ECG, creatininemia, cancer, Fibroscan, bone densitometry...

SECONDARY EVALUATION CRITERIA Age, sex, phototype, CD4 lymphocytes count, viral load, nadir CD4, antiretroviral exposure, alcohol, tobacco ...

METHODOLOGY Monocentric retrospective study STATISTICS Frailty model, chi2 test, test U INCLUSION CRITERIA Seropositive for HIV, age\>18 years Follow-up at least once in the Internal Medicine department between 1995 and 2018 CRITERIA OF EXCLUSION Refusal of the patient or unreachable patient NUMBER OF PATIENTS Between 200 and 300 CALENDAR Duration of inclusions: 3 months Duration of participation of the patient: 20 years (retrospectives ...) Duration of the study: 1 year

Primary Outcome Measures: renal aging, creatinin level, creatinin clearance, microalbuminuria, yearly|pulmonary aging, respiratory functional test, at last one|liver aging, elastometry (Fibroscan\*), at last one|neurological aging, memory tests, at last one|vascular aging, intima-media thickness, systolic and diastolic blood pressure, at last one|Bone aging, osteodensitometry, at last one|heart aging, ECG, echography, at last one
Evaluation of CMV/EBV-CMI in Haploid HSCT
NCT Number: NCT06554197
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Hematopoietic Stem Cell Transplantation|Cytomegalovirus Infections|Epstein-Barr Virus Infections
Interventions: DIAGNOSTIC_TEST: CMV/EBV-CMI
Sponsor: The First Affiliated Hospital of Soochow University
Sex: ALL
Age: CHILD, ADULT
Enrollment: 60
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-13
Completion Date: 2026-07-31
Locations: First Affiliated Hospital of Soochow University, Suzhou, Jiangsu, 215006, China

Summary:
The purpose of this prospective, open-label, Single Arm, single-center study is to evaluate the cytomegalovirus and Epstein-Barr virus specific immune reestablishment for patients with hemopathy undergoingin prophylaxis for cytomegalovirus in haploid hematopoietic stem cell transplantation(haplo-HSCT) .

Primary Outcome Measures: CMV-CMI, CMV specific immune reconstitution from pre-HSCT to 180 days after HSCT, 6 months after transplantation|EBV-CMI, EBV specific immune reconstitution from pre-HSCT to 180 days after HSCT, 6 months after transplantation
Secondary Outcome Measures: Cumulative incidence of CMV reactivation, The cumulative incidences of CMV reactivation after transplantation., 1 years after transplantation|Cumulative incidences of EBV reactivation, The cumulative incidences of EBV reactivation after transplantation, 1 years after transplantation|Overall survival (OS), Overall survival (OS) is defined as the time from randomization to death resulting from any cause., 1 years after transplantation|Non-relapse mortality (NRM), Non-relapse mortality (NRM) is defined as the time from enrollment to death of any causes other than hematologic disease relapse., 1 years after transplantation|Relapse-related mortality (RRM), Relapse-related mortality (RRM) is defined as the time from enrollment to death of relapse., 1 years after transplantation|GVHD-free and relapse-free survival (GRFS), GRFS is defined as the time from graft infusion to the onset of grades 3 to 4 aGVHD, moderate to severe cGVHD, or relapse/disease progression/death., 1 years after transplantation|Cumulative incidences of aGVHD, The diagnosis and grading of aGVHD are based on the modified Glucksberg grading standard., 100 days after transplantation
Hippotherapy Simulators on Trunk Control and Upper Extremity Functions in Cerebral Palsy
NCT Number: NCT06554171
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cerebral Palsy
Interventions: OTHER: Hippotherapy group|OTHER: Control group
Sponsor: Firat University
Sex: ALL
Age: CHILD, ADULT
Enrollment: 20
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-20
Completion Date: 2024-10-30
Locations: Songul Baglan Yentur, Elazığ, 23100, Turkey

Summary:
The hippotherapy simulator imitates the three-dimensional mechanical movement and walking of the horse and transfers the mechanical effect to the rider during hippotherapy. The aim of this study was to investigate the effect of exercise program with hippotherapy simulator on upper extremity functions and trunk control of individuals with cerebral palsy.All individuals diagnosed with Cerebral Palsy who agree to participate in the study and meet the inclusion criteria will be randomly divided into two groups as Study and Control Group. In addition to conventional physiotherapy, the study group will be trained in the Hippotherapy Simulature for 15 minutes a day, 5 days a week for 4 weeks.n addition to conventional physiotherapy, the control group will be allowed to sit in the Hippotherapy Simulature for 15 minutes a day, 5 days a week for 4 weeks. However, the simulator will be kept in closed position to prevent oscillations.

Primary Outcome Measures: Hand Function assessment, Jabson Taylor hand function test will be used. The test measures the accuracy of speed and performance on a variety of grip and release tasks using everyday items., 2 minutes
Secondary Outcome Measures: Trunk control assessment, The Trunk Control Measurement Scale (TCMS) will be used to assess trunk control in the participants. The fifteen-item SCS assesses static and dynamic components of the trunk during sitting., 2 minutes|Balance assessment, Timed up and go test will be used to evaluate balance. The patient is asked to stand up from the chair without support from the chair, walk 3 m, walk back towards the chair without touching anything and take the sitting position again. The time starts when the patient stands up from the chair and ends when the patient returns to the chair and sits down again., 2 minutes
De-escalation of Adjuvant Radiation for Low-Risk HPV Oropharyngeal Cancers
NCT Number: NCT06554158
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Oropharynx Cancer
Interventions: RADIATION: Radiation Therapy
Sponsor: Georgetown University
Collaborators: MedStar Georgetown University Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2019-08-01
Completion Date: 2028-12-31
Locations: Medstar Georgetown University Hospital, Washington, District of Columbia, 20007, United States

Summary:
The goal of this clinical trial is to learn whether for intermediate-risk patients who have undergone Transoral Robotic Surgery for HPV/p16(+) oropharyngeal cancer and have minimal smoking history, whether these patients can be treated with a lower-than standard dose, with omission of the primary site in the oropharynx. The main questions it aims to answer are:

Does radiotherapy site and dose-de-escalation lead to similar outcomes compared to historical data on tumor control in patients who are treated with standard radiation doses and treatment fields?

Participants will:

Undergo treatment with a lower than standard radiation dose (50Gy in 25 fractions, with either IMRT or proton beam therapy) and to a smaller than standard radiation field (to the neck only, excluding the original site of tumor in the oropharynx)

Primary Outcome Measures: Progression Free Survival, Progression Free Survival, 2 year
Secondary Outcome Measures: QOL, Quality of Life, 2 year|Local Control, Local Control, 2 year|Regional Control, Regional Control, 2 year|DMFS, Distant Metastasis-Free Survival, 2 year|OS, Overall Survival, 2 year|PEG, PEG tube placement, 1 year
Other Outcome Measures: translation, saliva and/or blood collection, 5 years
Development and Evaluation of AI Program for Predicting Bacterial Species From Urine Gram Stain Specimens
NCT Number: NCT06554145
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Bacterial Infections
Sponsor: GramEye
Collaborators: Keio University|Kameda Medical Center
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 15000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-09-25
Completion Date: 2028-08
Locations: Keio University Hospital, Shinjuku-Ku, Tokyo, 1608582, Japan

Summary:
The purpose of this research is to develop an AI that estimates bacterial species from Gram staining images of urine specimens, and to evaluate the accuracy and labor reduction effect of Gram staining Automation system equipped with this AI.

Primary Outcome Measures: Rate of concordance between AI-estimated results with actual culture results regarding urine Gram stain specimens, Evaluate the concordance rate between bacterial species estimation results and culture results obtained using the automatic Gram staining device with an AI program installed for analyzing urine Gram stain specimens., Day1
Respiratory Muscle Strength and Aerobic Capacity in Scleroderma
NCT Number: NCT06554132
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Scleroderma
Interventions: OTHER: Scleroderma Group|OTHER: Healthy group
Sponsor: Firat University
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 15
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-20
Completion Date: 2024-10-30
Locations: Songul Baglan Yentur, Elazığ, 23100, Turkey

Summary:
Primary aim of this study was to compare respiratory muscle strength, aerobic capacity, dyspnea, pulmonary function tests and fatigue values with healthy controls. The secondary aim was to evaluate the relationship between respiratory muscle strength and other parameters in these patients and to examine the factors that may affect respiratory muscle strength. Respiratory muscle strength, aerobic capacity, respiratory function tests and fatigue will be evaluated

Primary Outcome Measures: Respiratory muscle strength assessment, Respiratory muscle strength will be assessed with an intraoral pressure gauge. These are the intraoral pressures measured at maximal respiration against a valve that closes the airways. When applying MIP, the patient is asked to perform maximal expiration. As a result, the patient is asked to maximally inspire against the closed airway and maintain this for 1-3 seconds. MEP, on the other hand, after maximal inspiration, the patient is asked to perform maximal expiration against the closed airway for 1-3 seconds., 5 minutes
Secondary Outcome Measures: Aerobic capacity assessment, Aerobic capacity will be assessed using exercise testing. VO2max will be assessed using the Cosmed FitMate Pro® (Cosmed, Italy). The FitMate Pro® includes a turbine flowmeter to measure ventilation and a galvanic fuel cell oxygen sensor to analyze the oxygen fraction in expired gases., 10 minutes|Fatigue assessment, Fatigue will be assessed with the Fatigue Severity Scale (FSS), the Turkish validity and reliability of which was performed by Armutlu et al. This scale includes 9 questions related to fatigue., 2 minutes|Pulmonary function test, Pulmonary function test is routinely performed in Ssk patients. FEV1, DLCO and FEV1/FVC values will be recorded from the patients' files., 5 minutes
Surgical Treatments of Tricuspid Valve Regurgitation After Cardiac Surgery
NCT Number: NCT06554119
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Tricuspid Valve Regurgitation; Complications, Longterm Outcome
Interventions: PROCEDURE: Huanlei Huang
Sponsor: Guangdong Provincial People's Hospital
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 375
Study Design: Observational Model: |Time Perspective: p
Start Date: 1999-01
Completion Date: 2025-01
Locations: Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences), Southern Medical University, Guangzhou, Guangdong, 510080, China

Summary:
This study aims to present our center's experience in managing postoperative tricuspid valve regurgitation over the past 25years and to analyze the outcomes of these surgical treatments.

Primary Outcome Measures: death rate, perioperative and longterm, 1999-01 - 2025-01|complications, perioperative and longterm complications, 1999-01 - 2025-01
Secondary Outcome Measures: redo of tricuspid valve, redo of tricuspid valve during the follow-up, 1999-01 - 2025-01
Neuromuscular Electrical Stimulation in Fibromyalgia
NCT Number: NCT06554106
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Fibromyalgia
Interventions: OTHER: Neuromuscular Electrical Stimulation Group|OTHER: Control Group
Sponsor: Firat University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-20
Completion Date: 2024-10-30
Locations: Songul Baglan Yentur, Elazığ, 23100, Turkey

Summary:
Fibromyalgia syndrome (FMS) is associated with chronic widespread pain and at least eleven positive tender points out of 18 according to the American College of Rheumatology (ACR) 1990 criteria. Neuromuscular electrical stimulation (NMES) stimulates nerve fibers providing innervation in healthy muscle and muscle fibers in denervated muscle to produce contraction. All patients will be taught neck normal joint motion exercises, upper trapezius stretching exercise and posture exercises. Patients included in the study will be randomly distributed equally between the two groups. In addition to the study group, NMES will be applied to the upper trapezius muscle for 30 minutes 5 days a week for 4 weeks. Pain, disability and sleep quality of all patients will be evaluated.

Primary Outcome Measures: Pain assessment, Pain intensity will be evaluated according to VAS. Patients will be asked to mark the pain intensity on a 10 cm line. 0 means no pain and 10 means unbearable pain., 1 minute
Secondary Outcome Measures: Disability assessment, Fibromyalgia Impact Questionnaire will be used. The FIQ consists of 10 items. The first item includes daily activity questions scored on a Likert scale from 0 to 3 (always able to do - never able to do)., 2 minutes|Sleep quality assessment, Pittsburg Sleep Quality Index will be used to evaluate sleep quality, 2 minutes
Study Comparing the PathKeeper System for Pedicle Screw Positioning in Spine Surgery With Traditional Care
NCT Number: NCT06554093
Acronym: PKSforPSP
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Scoliosis|Scoliosis; Adolescence|Scoliosis Kyphosis|Scoliosis Lumbar Region|Scoliosis Thoracic Region|Pathologic Fracture
Interventions: DEVICE: Medical Device - PKS
Sponsor: Deep Health Ltd.
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 32
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-10-30
Completion Date: 2025-10-30
Locations: Leeds Hospital, Leeds, West Yorkshire, LS9 7TF, United Kingdom

Summary:
The goal of this is to evaluate performance of the Pathkeeper Surgical System. The main question\[s\]it aims to answer are: 1) evaluate pedicle screw position Participants will in compare Experimental arm: PathKeeper System (PKS) with control arm

Primary Outcome Measures: Accuracy of the screw implantation by Gertzbein-Robbins scale, Mean and STD of Gertzbein-Robbins classification scale based on a low-dose post-operative CT scan, Post-operative CT scan to be performed before hospital discharge and evaluation can be done right after or at the end of the of the data collection
Secondary Outcome Measures: Evaluate radiation exposure dose and time in the operating room during the procedure in each study arm and comparatively., Mean and STD Values in milli-gray (mGy) and seconds collected from the c-Arm, 24 hours after surgery|Evaluate time-per-screw for the experimental device arm (PKS) arm., Operative time per screw, Values to be collected during each surgery once the last screw insertion is completed (1-2 hours within the surgery)