pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Timing of Energy Availability on Menstrual Cycle Function
NCT Number: NCT06471582
Acronym: FAST
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Menstrual Irregularity
Interventions: DIETARY_SUPPLEMENT: Artificially Sweetened Carbohydrate Beverage|DIETARY_SUPPLEMENT: Artificially Sweetened Beverage
Sponsor: University of Colorado, Colorado Springs
Sex: FEMALE
Age: ADULT
Enrollment: 64
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-08-01
Completion Date: 2027-08-31

Summary:
The primary aim of this clinical trial is to evaluate how fasted prolonged exercise may influence circulating reproductive hormones (i.e., estradiol, progesterone, luteinizing hormone) and menstrual cycle length when energy availability is maintained at or above 30 kcal/kg lean body mass/ day among women who regularly do running or cycling exercise. A secondary aim is to determine the effects of fasted prolonged exercise on serum leptin and cortisol.

Participants will be asked to do the following over a \~3 month enrollment period:

* attend a laboratory visit at the beginning of the study to have their resting metabolic rate, aerobic fitness, and body composition tested
* monitor their menstrual cycle length, urine hormones, perceived stress levels, and diet for \~3 months
* complete 3, 90-minute exercise sessions on a stationary bike or treadmill either fed (consuming a carbohydrate meal 1 h prior and 0.7 g carbohydrate/ kg body mass/ h during exercise) or fasted (consuming no meal prior and no carbohydrates during exercise) during month \~3
* saliva samples will be taken prior to and after 90-minute exercise sessions for quantification of leptin and cortisol

Primary Outcome Measures: Urinary estrone-3-glucuronide (E3G), ng/mL, 3 months|Urinary pregnanediol glucuronide (PdG), ug/mL, 3 months|Urinary luteinizing hormone (LH), MIU/mL, 3 months|Menstrual cycle length, days, 3 months
Secondary Outcome Measures: Salivary cortisol, ng/mL, 3 days|Salivary leptin, ng/mL, 3 days
Use of Eye Tracking to Aid in Autism Risk Detection
NCT Number: NCT06471504
Acronym: RCFET
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Autism
Interventions: DIAGNOSTIC_TEST: Eyelink Portable Duo
Sponsor: Indiana University
Sex: ALL
Age: CHILD
Enrollment: 100
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-10-01
Completion Date: 2025-10-01
Locations: Riley Hospital for Children, Indianapolis, Indiana, 46202, United States

Summary:
The study will use a non-invasive remote eye-tracking system (Eyelink Portable Duo) to acquire a short series of eye-tracking measures.

Primary Outcome Measures: Agreement between eye-tracking biomarker score and diagnosis, The composite eye-tracking biomarker score, a consolidated measure based on eye-tracking indices that predict autism outcome, will be compared to the categorical autism diagnosis (autism presence/absence). Clinical diagnosis is obtained based upon a standard clinical evaluation conducted by an expert clinical psychologist. The evaluation will include 1) a semi-structured caregiver(s) clinical interview to gather information about developmental history and autism symptoms and 2) a battery of standardized child clinical observational measures. The evaluation will be conducted over a one-time 2-hour clinical autism evaluation. Eye-tracking will be recorded immediately following the clinical evaluation for a period of up to 15 minutes., Day 1
Driving Pressure-guided Positive End-expiratory Pressure to Prevent Postoperative Atelectasis in Obese Children: a Prospective, Randomized Controlled Clinical Trial
NCT Number: NCT06471491
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Driving Pressure|Positive End-expiratory Pressure|Postoperative Atelectasis|Obese
Interventions: OTHER: Driving pressure-guided positive end-expiratory pressure
Sponsor: Henan Provincial People's Hospital
Sex: ALL
Age: CHILD, ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-01-01
Completion Date: 2025-05-31
Locations: Henan Provincial People's Hospital, Zhengzhou, Henan, 453100, China

Summary:
At present, the use of lung protective ventilation strategies in children is mainly based on adult and intensive care unit data. Although obese children may benefit more from lung protective ventilation, there are few studies on the use of lung protective ventilation strategies in obese children during surgery. Therefore, the investigators hypothesized that intraoperative use of LPV strategies in obese pediatric surgery patients can reduce atelectasis and improve the incidence of postoperative pulmonary complications.

Primary Outcome Measures: Incidence of atelectasis in both groups at the end of surgery, Incidence of atelectasis in both groups at the end of surgery, at the end of surgery
The Combination of IVIG, Dexamethasone and a Megadose of PBSCs for Decreasing DSAs
NCT Number: NCT06471478
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Blood Disease
Interventions: COMBINATION_PRODUCT: intravenous immunoglobulin, dexamethasone and a megadose of peripheral-blood stem cell transfusion
Sponsor: Hematology department of the 920th hospital
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 11
Study Design: Observational Model: |Time Perspective: p
Start Date: 2019-04-01
Completion Date: 2023-08-30
Locations: 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China, Kunming, Yunnan, 650000, China

Summary:
Donor-specific antibodies (DSAs) are essential causes of graft rejection in haploidentical hematopoietic stem cell transplantation (haplo-HSCT). DSAs are unavoidable for some patients who have no alternative donor. Effective interventions to reduce DSAs are still needed, and the cost of the current therapies is relatively high. Investigators wanted to retrospectively analyzed the data of 11 DSA-positive participants who received haplo-HSCT at our center and evaluated the therapeutic efficacy of the combination of intravenous immunoglobulin (IVIG), dexamethasone and megadose of transfused peripheral blood stem cells (PBSCs) for DSA desensitization.

Primary Outcome Measures: Graft failure Rate, Number of patients who did not have graft engraftment. Graft failure was defined as the return of recipient hematopoiesis as confirmed by chemerism analysis as \<%% donor chimerism at +28 day after HSCT, 2 years
Secondary Outcome Measures: poor graft function rate, Number of patients who have \>95% donor chinerism but blood morphology does not return., 2 years|acute graft-versus-host disease rate, the incidence of patients who developed aGVHD, 2 years|chronic graft-versus-host disease rate, the incidence of patients who developed cGVHD, 2 years|nonrelapse mortality, 2 years|overall survival, 2 years|disease free survival, 2 years
An Investigation of Different Type Single Limb Exercise Training Effects in Copd
NCT Number: NCT06471439
Acronym: COPD
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Exercise
Interventions: OTHER: single leg exercise intervantion in COPD
Sponsor: Hacettepe University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 66
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2023-06-16
Completion Date: 2025-01-02
Locations: Elif Kocaaga, Ankara, Turkey

Summary:
COPD presents not only respiratory symtoms but also vascular or muscle dysfunction. Exercise limitation is observed in COPD. Especially, decreased exercise performance related to vascular and fatique in quadriceps muscle. Exercise training is important for aerobic performance increasing. Generally results show exercise training with both lower limb. Increaed arterial stiffness and fatigue are observed in COPD. One leg exercise training result is not enough to highlight these parameters.

Three types single leg exercise intervantion will be applied. Exercise capacity, muscle strength, lung function, electromyography, lactate and quality of life will be measured.

Primary Outcome Measures: six minute walk test, six minute walk test in meter, pre-intervention
Secondary Outcome Measures: cardiopulmonary exercise test, VO2 as ml/kg/min will be recorded from incremental cycle cpet test, beginning day 2|one leg cardiopulmonary exercise test, VO2 as ml/kg/min will be recorded from incremental cycle cpet test, beginning, day 3|quadriceps muscle strength assesing (repeated measeure), quadriceps muscle 10 repeated max muscle strength will be recorded at kilogram,, beginning day 1 and last day|isometrics quadriceps muscle strength assesing, quadriceps muscle isometric muscle strength will be recorded at kilogram, beginning day 1 and last day|lung function, FEV1/FVC ratio in %, beginning day 1 and last day|quality of life assesing, total score in 0-100 range, beginning day 1 and last day|arterial stiffness, total vascular resitance, augmentation index @ 75 and pulse wave velocity wil be determined arterial stiffness, beginning day 2 and last day|lactate measurement, lactate in mmol, beginning day 2 and last day|electromyography measurement, precentage of maximum volunteer contraction) %MVC values will be presented muscle fatigue (median frequence) and activation will be shown electromyograpy (EMG), beginning day 2 and last day
Evaluation of the Effect of the BOAT® Structured Prevention Program on Violence in Middle Schools
NCT Number: NCT06471413
Acronym: TheBOATeffect
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Students|Middle Schools|Prevention|Violence
Interventions: OTHER: The Prevention Toolbox : BOAT®
Sponsor: University Hospital, Montpellier
Sex: ALL
Age: CHILD
Enrollment: 5400
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-01
Completion Date: 2027-09-01

Summary:
Violence has major consequences for the health and development of children and teenagers, even though it is commonplace, particularly in secondary schools. The team at the Centre Ressources pour les Intervenants auprès d'Auteurs de Violences Sexuelles Languedoc-Roussillon (CRIAVS-LR, CHU Montpellier) has created a BOite A ouTils to prevent sexual and gender-based violence: the BOAT, for professionals working with children and teenagers aged between 5 and 18. Structured around 5 themes and 4 age groups, the BOAT is very easy to use. The 134 intervention sheets have been validated and designed to target a risk factor (to be reduced) or a protective factor (to be developed) so that children do not become perpetrators or victims of violence.

Primary Outcome Measures: changes in the incidence of violent behavior, The incidence of violent behavior for each study period will be calculated by dividing the number of violent incidents observed in the school, by the number of schoolchildren monitored over the period (in person/year) in the same school., between the three years preceding the middle school's inclusion (period without intervention) and the three years following the start of the study (period with or without intervention, depending on the intervention arm)
Secondary Outcome Measures: Students' well-being, substance use, risky sexual behavior and suicidal behavior, This computerized questionnaire will be sent via a link and completed directly and anonymously via the National Education Digital Workspace., every year at the end of the school year during three year|Teachers' perceived stress at work will be assessed using the PSS (Perceived Stress Scale) validated in French, It will be sent to teaching teams and completed anonymously via the ENT (Digital Workspace) offered by the French Ministry of Education., every year at the end of the school year during three year|School climate will be assessed using an anonymous ICS (Indice of School Climate ) questionnary, It will be sent to educational teams and completed via the ENT (digital Workspace), every year at the end of the school year during three year|The frequency of disclosures of violence or abuse during interventions, in order to guide them towards an appropriate course of care., every year at the end of the school year during three year|The number of reports (information of concern or alerts), The number of reports (information of concern or alerts), every year at the end of the school year during three year
Developing Strategies to Facilitate Consent of Legally Authorized Representatives to Clinical Trials
NCT Number: NCT06471400
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Critical Illness|Loss of Consciousness
Interventions: OTHER: interview
Sponsor: University Hospital Freiburg
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-06-18
Completion Date: 2026-12-31
Locations: Freiburg University Medical Center, Freiburg, 79106, Germany

Summary:
This study aims to gather insights into the perceptions of legal representatives regarding the recruitment process for clinical trials in the intensive care setting when the patients cannot decide for themselves. With this information, effective strategies will be developed to increase involvement and the feeling of ownership of LARs of (potential) participants in clinical trials and thus enhance and facilitate patient recruitment for clinical trials. The single-arm study design does not include a choice of comparator, as the focus of this trial is to explore the perceptions of the participants at first hand without comparing different cohorts or strategies.

Primary Outcome Measures: relative/LAR perception, The primary aim of the study is to evaluate the perceptions of LARs towards the recruitment process for clinical trials. This is an exploratory examination. All findings are considered merely hypothesis generating and will be used for designing further trials based on sound hypotheses following the findings from this trial., actual day
Unraveling the Genetic Basis of Nicotine Addiction for Novel Therapeutic Strategies
NCT Number: NCT06471387
Acronym: NicoGen
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Smoking Cessation|Smoking Cessation Intervention|Nicotine Addiction|Epigenetics|Molecular Biology|Genetic Epidemiology
Interventions: BEHAVIORAL: Flexiquit Smoking Cessation Intervention
Sponsor: University of Cyprus
Sex: ALL
Age: ADULT
Enrollment: 200
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-11-01
Completion Date: 2025-10-31
Locations: Center for Applied Neuroscience (CAN), Nicosia, 2100, Cyprus

Summary:
This case-control study aims to investigate the genetic and molecular bases of nicotine addiction to identify potential therapeutic targets. The project will involve drug repurposing using Mendelian Randomization, a smoking cessation intervention, and the analysis of methylation status in participants undergoing nicotine withdrawal.

Primary Outcome Measures: Novel druggable gene targets for smoking cessation, Genes encoding druggable proteins (targets of approved drugs or clinical candidates) whose genetically predicted expression levels are found to be causally associated with smoking cessation outcomes using Mendelian randomization approaches., Upon completion of Mendelian randomization analysis|Association between methylation of candidate genes and nicotine dependence scores, Difference in methylation levels of top genes between participants with high vs. low scores on the Fagerström Test for Nicotine Dependence., Baseline|Association between DNA methylation of candidate drug target genes and motivation to quit smoking scores, Difference in methylation levels of the top candidate drug target genes between participants with high vs. low scores on a validated motivation to quit smoking questionnaire., 3 and 6 months post nicotine cessation|Association between methylation and smoking relapse vulnerability, Difference in methylation of top genes between cases achieving 6+ month abstinence vs. controls who relapsed to smoking., 3 and 6 months post nicotine cessation
Secondary Outcome Measures: Gender differences in methylation associations, Differences between males and females in the associations between methylation of candidate genes and the motivation, dependence and relapse outcomes., 3 and 6 months post nicotine cessation
Pathophysiology of Circadian Rhythm Delayed Sleep Wake Phase Disorder
NCT Number: NCT06471374
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Delayed Sleep Phase Syndrome|Delayed Sleep Phase
Interventions: BEHAVIORAL: Circadian rhythm assessment|BEHAVIORAL: Light sensitivity assessment
Sponsor: University of Colorado, Boulder
Collaborators: Northwestern University|National Heart, Lung, and Blood Institute (NHLBI)
Sex: ALL
Age: CHILD, ADULT
Enrollment: 66
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-04-02
Completion Date: 2028-07
Locations: University of Colorado, Boulder, Colorado, 80303, United States|Northwestern University, Chicago, Illinois, 60611, United States

Summary:
The goal of this study is to understand factors that contribute to delayed sleep wake phase disorder (DSWPD). The investigators will examine whether patients with DSWPD exhibit alterations in circadian rhythms and sensitivity to light compared to healthy controls. The investigators will also test a new method of predicting circadian rhythms form a blood sample.

Primary Outcome Measures: Core body temperature, Body temperature measured with a pill, Continuously for 1. up to 39 and 2. 23 hours|Glucose, Blood sugar levels, Continuously for 1. up to 39 and 2. 23 hours|Subjective sleepiness, Self reported sleepiness, Every 2 hours|Psychomotor vigilance, Attention/Vigilance performance, Every 2 hours
Secondary Outcome Measures: Skin temperature, skin body temperature, Continuously for 1. up to 39 and 2. 23 hours|Melatonin, Melatonin levels in saliva, Hourly for 1. up to 39 hours and 2. every 20 minutes
Postoperative Pain Control in AIS Using Liposomal Bupivacaine vs. 0.25% Bupivacaine With Epinephrine
NCT Number: NCT06471348
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Post Operative Pain|Spinal Fusion
Interventions: DRUG: Bupivacaine liposome injectable suspension|DRUG: Bupivacaine Hydrochloride and Epinephrine Injection
Sponsor: Boston Children's Hospital
Sex: ALL
Age: CHILD
Enrollment: 128
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-06-15
Completion Date: 2028-08-31
Locations: Boston Children's Hospital, Boston, Massachusetts, 02115, United States

Summary:
A randomized controlled trial (RCT) investigating whether the local anesthetic injection of liposomal bupivacaine during posterior spinal fusion (PSF) for AIS is more effective in reducing acute postoperative opioid consumption compared to an equal volume injection of 0.25% bupivacaine with epinephrine for patients aged 10 to 17, with 128 patients randomly assigned to one of two arms: liposomal bupivacaine or 0.25% bupivacaine with epinephrine.

Primary Outcome Measures: Total amount of morphine equivalents per kilogram, Total amount of morphine equivalents per kilogram during the first 72 hours postoperatively., 72 hours postoperatively
Secondary Outcome Measures: Numeric Rating Scale (NRS) pain scores, The average Numeric Rating Scale pain score (on a scale of 0-10) during the first 72 hours postoperatively will be computed from at most six values typically obtained every four to six hours following surgery. The higher the score, the higher the experienced pain of the individual., 72 hours postoperatively|Pain, functional ability, and mental health scores, SRS-22r scores at 1-, 6-, 12-, and 24-months post-operatively. The Scoliosis Patient Questionnaire Version 22r (SRS-22r) is a patient-reported outcome instrument with 22 questions that evaluates the impact of scoliosis and surgery on patient quality of life. Scores from the SRS-22r are compiled into five domain scores: function, pain, self-image, mental health, and satisfaction with management of scoliosis. Each domain score is reported on a scale form 1-5. The lower the score, the worse the outcome., 1-, 6-, 12-, and 24-months postoperatively
A Multi-Disciplinary Technology-Based Care for Diabetic Ketoacidosis in Patients With Type 1 Diabetes
NCT Number: NCT06471322
Acronym: DKA
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Diabetic Ketoacidosis
Interventions: DEVICE: Continuous Glucose Monitoring (CGM)|OTHER: Standard of Care
Sponsor: The Cleveland Clinic
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 12
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-09-01
Completion Date: 2026-12-01
Locations: The Cleveland Clinic Foundation, Cleveland, Ohio, 44195, United States

Summary:
The study team proposes that use of a novel multi-disciplinary approach with continuous glucose monitoring technology can significantly improve glycemic control and reduce readmissions among those with type 1 diabetes mellitus (T1DM) admitted for Diabetic ketoacidosis (DKA). This will also help promote a pathway for care of these patients after admission utilizing resources which are available within the Endocrinology, Diabetes and Metabolism department at the Cleveland Clinic.

Primary Outcome Measures: Measure improvement in glycemic control, To compare improvement in glycemic control (HBA1c measured in % glycosylated hemoglobin) between baseline at hospitalization for DKA and 6 months later using CGM intervention versus standard of care., 6 months
Secondary Outcome Measures: Assess change in number of readmissions, To assess change in number of readmissions between baseline and 6 months later using CGM intervention versus standard of care., 6 months
Effect of Theta Burst Transcranial Magnetic Stimulation on Patients With Dysphagia After Stroke
NCT Number: NCT06471309
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Stroke|Dysphagia|Functional Near- Infrared Spectroscopy|Transcranial Magnetic Stimulation
Interventions: DEVICE: Theta burst transcranial magnetic stimulation
Sponsor: Zhang Xiaohui
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 45
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2025-12-15

Summary:
The purpose of this study was to observe the effect of Theta burst transcranial magnetic stimulation (TBS) on swallowing function in patients with dysphagia after stroke (PSD). Functional near- infrared spectroscopy (fNIRS) was used to detect the changes in activation and functional connectivity of related brain regions in PSD patients treated with intermittent TBS（iTBS）stimulation on the affected side and consistent TBS（cTBS） stimulation on the healthy side. To investigate the effects of TBS on swallowing related cortical excitability in stroke patients with dysphagia and explore its possible mechanism, and provide theoretical basis for the treatment of PSD patients.

Primary Outcome Measures: Rosenbek Penetration-aspiration scale, The Rosenbek Penetration-aspiration scale assesses the patient's swallowing function by assessing the severity of penetration and aspiration. The results of Rosenbek Penetration-aspiration scale are divided into 8 grades from 1 to 8, and the lower the score, the better the swallowing ability., The first evaluation was before the intervention and the second evaluation was after 2 weeks of treatment.|Standardized Swallowing Assessment, The Standardized Swallowing Assessment scale is divided into three parts: clinical examination, water test, and normal eating, and is used to evaluate the safety and effectiveness of swallowing. The highest score of Standardized Swallowing Assessment scale is 46, and the lowest score is 18. The lower the score, the better the swallowing function., The first evaluation was before the intervention and the second evaluation was after 2 weeks of treatment.|functional near- infrared spectroscopy, fNIRS is a brain function detection technology, which can indirectly reflect the brain neural activity by detecting the content of oxygenated and deoxygenated hemoglobin in the cerebral cortex in real time. In this study, fNIRS was used to assess brain region activation and network connectivity characteristics during swallowing tasks., The first evaluation was before the intervention and the second evaluation was after 2 weeks of treatment.
Contribution of Per Dialytic Physical Activity in Chronic Dialysis Patients
NCT Number: NCT06471283
Acronym: ACTIDIAL
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Dialysis
Interventions: OTHER: physical activity
Sponsor: Centre Hospitalier Intercommunal André Grégoire
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-03-14
Completion Date: 2025-03-31
Locations: CHI Andre Gergoire, Montreuil, 93100, France

Summary:
Dialysis patients have reduced walking capacity and an important risk of high blood pressure. These complications are associated with a decline in quality of life and increased mortality. The hypothesis of the study is to show that physical activity during the dialysis session in dialyzed patients has a benefit on quality of life, as well as on muscle, cardiovascular and dialysis parameters.

Primary Outcome Measures: Change in the quality of life of patients, Score of the Short Form-36 (SF36) questionnaire. The SF36 score varies from 0 to 100. A low score reflects a perception of poor health, loss of function, and presence of pain.

A high score reflects a perception of good health, an absence of functional deficit and pain., 17 weeks
Secondary Outcome Measures: Change in dialysis parameters (KT/V= clearance time/volume), measurement of clearance time/volume (KT/V), 17 weeks|Change in muscle parameters, Score of the Medical research council scale (MRC), 17 weeks|Change in nutritional parameters, Measurement of body mass index (BMI), 17 weeks|Change in inflammatory parameters, measurement of CRP, 17 weeks|Change in lipid profile, Measurement of total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides, 17 weeks|Change in blood pressure, Measurement of systolic and diastolic blood pressure, 17 weeks|Change in heart rate, measurement of pulse, 17 weeks|Change in glycemic control, Levels of albumin, 17 weeks|Change in glycemic control, Levels of prealbumin, 17 weeks
Validation of Salivary Proteomic Biomarkers for Early Detection of Oral Cancer in Egyptian Population
NCT Number: NCT06471270
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Oral Cancer
Interventions: DIAGNOSTIC_TEST: histologic evaluation|DIAGNOSTIC_TEST: biochemical analysis|DIAGNOSTIC_TEST: clinical examination
Sponsor: British University In Egypt
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: DIAGNOSTIC
Start Date: 2023-07-15
Completion Date: 2024-03-15
Locations: British University in Egypt, Cairo, 112344, Egypt

Summary:
The present investigation was conducted on 100 individuals allocated into four groups; 25 healthy controls, 25 patients having OPMDs with dysplasia; 25 patients having OPMDs without dysplasia, and 25 oral cancer patients. Demographic data including data related to different risk factors, modified gingival index, oral hygiene level, in addition to salivary levels of IL-6, IL-8 and sCD44 were assessed.

Primary Outcome Measures: Quantities of IL-6 and IL-8, assessed in all samples using an ELISA kit (Orgenium laboratories, Business Unit, Finland). The test principles apply a sandwich-type ELISA where a polyclonal anti-antibody, adsorbed onto microwells, binds IL-6 and IL-8 in the samples, Results were expressed in pg/ml, baseline|Levels of sCD44, measured using an ELISA assay (Bender MedSystems, Vienna, Austria) that identifies all normal and variant isoforms. Saliva samples were centrifuged at 2000 Xg and the supernatants were separated and stored at -80 ̊C till processing, which was done according to manufacturer's instructions. Results were expressed in ng/ml., Baselone
Secondary Outcome Measures: MGI (modified gingival index), Modified gingival index (MGI) evaluates the presence and degree of gingival inflammation. A score of 0 means absence of inflammation. 1 indicates mild inflammation (slight redness) of any part of the gingiva. 2- mild inflammation of the whole gingiva. 3- moderate inflammation (moderate redness, edema, and/or hypertrophy) of the gingiva. 4-severe inflammation (marked redness and spontaneous bleeding) of the gingiva., baseline
Efficacy and Safety of SHR-1918 in Patients With Hyperlipidemia
NCT Number: NCT06471218
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Hyperlipidemia
Interventions: DRUG: SHR-1918; SHR-1918 Placebo
Sponsor: Beijing Suncadia Pharmaceuticals Co., Ltd
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 42
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-06
Completion Date: 2025-06
Locations: Meizhou People's Hospital, Meizhou, Guangdong, 514031, China

Summary:
Evaluation of the efficacy and safety of multiple subcutaneous injections of SHR-1918 in patients with hyperlipidemia in poor control: a multicenter, randomized, double-blind, placebo-controlled phase II clinical trials

Primary Outcome Measures: Percent change in calculated LDL-C from baseline to week 24, from baseline to week 24
Secondary Outcome Measures: Percent change in calculated TG from baseline to week 24, from baseline to week 24
A Study of BL-B01D1+PD-1 Monoclonal Antibody in Patients With Unresectable Locally Advanced or Recurrent Metastatic Triple-negative Breast Cancer
NCT Number: NCT06471205
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Triple-negative Breast Cancer
Interventions: DRUG: BL-B01D1|DRUG: PD-1 Monoclonal Antibody
Sponsor: Sichuan Baili Pharmaceutical Co., Ltd.
Collaborators: Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 52
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-02
Completion Date: 2026-07
Locations: Fudan University Shanghai Cancer Center, Shanghai, Shanghai, China

Summary:
This phase II study is a clinical study to explore the efficacy and safety of BL-B01D1 combined with PD-1 monoclonal antibody in patients with unresectable locally advanced or recurrent metastatic triple-negative breast cancer.

Primary Outcome Measures: Objective Response Rate (ORR), Objective response rate (ORR) is defined as the number of CR and PR in the treatment and control groups divided by the number of that group in the full analysis set (FAS)., Up to approximately 24 months|Recommended Phase II Dose (RP2D), The RP2D is defined as the dose level chosen by the sponsor (in consultation with the investigators) for phase II study, based on safety, tolerability, efficacy, PK, and PD data collected during the dose escalation study of BL-B01D1., Up to approximately 24 months
Secondary Outcome Measures: Progression-free survival (PFS), Progression-free survival (PFS) as assessed by BIRC is defined as the time between the date subjects are randomized and the first observation of disease progression (based on BICR's image-based assessment) or death., Up to approximately 24 months|Disease Control Rate (DCR), Disease Control Rate (DCR) : Percentage of all randomized subjects who rated the best overall response (BOR) as complete response (CR), partial response (PR), and disease stabilization (SD) according to RECIST 1.1 criteria., Up to approximately 24 months|Duration of Response (DOR), Duration of Response (DOR) : defined as the period from the date when tumor response is first recorded to the date when objective tumor progression is first recorded or the date of death., Up to approximately 24 months|Treatment Emergent Adverse Event (TEAE), TEAE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally emerging, or any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition during the treatment of BL-B01D1. The type, frequency and severity of TEAE will be evaluated during the treatment of BL-B01D1., Up to approximately 24 months
Predictors of Thrombus Burden in STEMI Patients and Their Impact on Outcome
NCT Number: NCT06471192
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: STEMI
Interventions: PROCEDURE: PPCI
Sponsor: Assiut University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07
Completion Date: 2025-12

Summary:
ST-segment elevation myocardial infarction (STEMI) is the most acute manifestation of coronary artery disease and is associated with great morbidity and mortality.(1). High thrombus burden (HTB) during ST-segment elevation myocardial infarction (STEMI) could translate into worse clinical outcomes.(2). HTB has been defined as the occurrence of thrombo- sis during myocardial infarction, as determined by a thrombus score ≥ 3 in the infarct-related artery (IRA) or as a "cut-off" occlusion pattern and/or large reference vessel diameter (≥ 3.5 mm) in an occluded IRA.(3) Many variables were used to predict the presence of high thrombus burden in STEMI patients undergoing primary PCI. higher C-reactive protein, and low serum albumin, higher C - reactive protein to albumin ratio (4) which can be used as a surrogate marker of pro-inflammation and is closely related to pro-thrombotic state. Furthermore higher neutrophil-lymphocyte ratio is closely associated with HTB and short-term mortality in STEMI patients (5). MAPH score, which is a new score that combines blood viscosity biomarkers such as mean platelet volume (MPV), total protein and hematocrit, can be used to predict thrombus burden in ST-segment elevation myocardial infarction (STEMI) patients.(6). In addition, TyG index, a valid surrogate marker of insulin resistance, is an independent predictor of LTB in STEMI patients who underwent primary PCI and can be used as an indicator of increased intracoronary thrombus burden. (7). Furthermore, Initial troponin level may be associated with larger thrombus burden within a coronary artery. This finding may influence coronary flow and needs to be taken into consideration during primary coronary intervention.(8). The atherogenic index, a logarithmically transformed ratio of molar concentrations of triglycerides to HDL-cholesterol, can be used as a reliable marker for increased coronary thrombus burden, which is associated with adverse cardiovascular outcomes(9).whole blood viscosity has also been showing that WBV at both shear rates is a significant predictor of HTB in NSTEMI patients(10).

In our research, we aim to study the effect of these different parameters on thrombus burden and their impact on patients outcome at 6 months

Primary Outcome Measures: To evaluate the effect different factors on thrombus burden in patients with STEMI., To evaluate the effect different factors on thrombus burden in patients with STEMI., 1 year
Secondary Outcome Measures: Impact of these factors on patients outcomes at 6 months., Impact of these factors on patients outcomes at 6 months., 18 months
Functional Magnetic Resonance Imaging Study in Schizophrenia Patients and Correlation With Cognitive Impairments
NCT Number: NCT06471179
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Schizophrenia|Cognitive Impairment
Interventions: DEVICE: Functional MRI
Sponsor: Assiut University
Sex: ALL
Age: ADULT
Enrollment: 40
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-10-01
Completion Date: 2027-01-01

Summary:
1. Comparison of functional activity at different brain areas related to different cognitive domains e.g. Memory, visuospatial abilities, executive functions, attention, concentration, language, orientation in schizophrenia to healthy subjects.
2. Correlation with resting functional activity at brain areas with clinical deterioration in cognitive functions.

Primary Outcome Measures: functional Magnetic Resonance Imaging, different regional brain activity among schizophrenic and healthy subjects and correlation with cognitive function, baseline
The Effect of Different Treatment Modalities of Tubal Ectopic Pregnancy on Ovarian Reserve: a Prospective Cohort Study
NCT Number: NCT06471166
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Ectopic Pregnancy
Interventions: DIAGNOSTIC_TEST: Amh hormone
Sponsor: Assiut University
Sex: FEMALE
Age: ADULT
Enrollment: 90
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-10
Completion Date: 2025-10-10
Locations: Assiut university, Assiut, Egypt

Summary:
Detect the effect of different treatment modalities of tubal ectopic pregnancy on ovarian reserve

Primary Outcome Measures: Change in levels of AMH pre and post treatment, 3 months
Effect of Empowerment Program on Children's Knowledge, Attitude, Self-Efficacy, and Practice of Nail Biting.
NCT Number: NCT06471153
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Nail Biting
Interventions: BEHAVIORAL: Empowerment Program Based on BASNEF Model|BEHAVIORAL: Routine Health Education
Sponsor: Alexandria University
Sex: ALL
Age: CHILD, ADULT
Enrollment: 135
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2023-04-20
Completion Date: 2023-12-20
Locations: Alexandria University, Alexandria, 32511, Egypt

Summary:
The study aims to evaluate the effect of an empowerment program based on the BASNEF model on children's knowledge, attitude, self-efficacy, and practice of nail biting.

Research Hypothesis H1: The application of an empowerment program based on the BASNEF model has a positive impact on children's knowledge, attitude, self-efficacy, and practice of nail biting.

Primary Outcome Measures: Children's Nail-Biting Knowledge, It includes ten questions about nail biting revolving around the definition (2 items), predisposing factors (2 items), complications and adverse effects (3 items), and management (3 items). A score of (1) was given for the correct answer and zero for the incorrect one., one month|Children's Nail-Biting Practice/Habits, It includes ten items describing the children's nail-biting habit, including frequency and duration (2 items), aggravating factors (2 items), areas involved in nail-biting (3 items), and description of nail-biting behavior (3 items). They are instructed to self-monitor their nail-biting behaviors on five a 5-point Likert scale ranging from very frequent (4) to never (0)., one month|Children's Attitude and Self-efficacy Towards Nail-biting, It consists of 13 items; 10 items measure the child's attitude, and three items assess their intention to act (self-efficacy). Children were asked to rate their answers on a 5-point Likert scale ranging from Strongly Agree (4) to (0) Strongly Disagree., one month|Subjective Norms and Enabling Factors of Nail-Biting Among Children, The questionnaire includes ten yes/No questions divided into two categories. The subjective norms category consists of 8 items describing the external factors that influence children either to increase or quit their nails, one month
Maternal Cardiovascular Adaption to Pregnancy in IVF Patients Following Frozen Embryo Transfer (FET)
NCT Number: NCT06471140
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: IVF|Frozen Embryo Transfer (FET)|Cardiovascular Adaption|Magnetic Resonance Imaging (MRI)|Preeclampsia
Interventions: OTHER: magnetic resonance imaging (MRI)
Sponsor: Aalborg University Hospital
Collaborators: Regionshospitalet Viborg, Skive
Sex: FEMALE
Age: ADULT
Enrollment: 75
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-10-01
Completion Date: 2028-08-01

Summary:
Aim of the study is to explore the effect of a lacking corpus luteum on maternal cardiovascular and metabolic adaption to pregnancy by the use of magnetic resonance imaging (MRI).

Primary Outcome Measures: Maternal cardiovascular adaption to pregnancy, From early pregnancy to six months postpartum|Maternal metabolic adaption to pregnancy, From early pregnancy to six months postpartum|Placental function and fetal oxygenation estimated by longitudinal T2* weighted placental and fetal MRI, From early pregnancy to six months postpartum
Evaluation of the Efficacy of Systemic Treatments for Alopecia (ESTAA)
NCT Number: NCT06471114
Acronym: ESTAA
Status: ACTIVE_NOT_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Alopecia Areata
Sponsor: University Hospital, Brest
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 250
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-11-01
Completion Date: 2025-10-30
Locations: Chu Brest, Brest, 29609, France

Summary:
The aim of our study was to retrospectively assess the efficacy and safety of systemic treatments in patients with alopecia areata, by recruiting cases from the HUGO network (Hôpitaux Universitaires du Grand Ouest), a network of 5 hospitals : Brest, Nantes, Rennes, Angers and Tours.

Primary Outcome Measures: Short-term efficacy and security of systemic treatments, Response rates including complete response or partial response or no response for each modality of treatment. and Side effects rate, From January 2010 to December 2020
Secondary Outcome Measures: Long-term efficacy of systemic treatments, Among responders (CR and PR), the maintained response rate and relapse rate, From January 2010 to December 2020
Applying Artificial Intelligence to Identify Subphenotypes of Acute Kidney Injury in Mexican Patients With Severe COVID-19
NCT Number: NCT06471101
Acronym: IA-COVAKI
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: COVID-19|Acute Kidney Injury
Interventions: DIAGNOSTIC_TEST: clusters
Sponsor: Instituto Nacional de Enfermedades Respiratorias
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 2934
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-18
Completion Date: 2024-06-18
Locations: Instituto Nacional de Enfermedades Respiratorias, Mexico City, 14080, Mexico

Summary:
The goal of this observational study was to identify subphenotypes of acute kidney injury patients with COVID-19, and the investigators analyzed their impact on mortality. The study included demographic and clinical variables of the participants. The implementation of Machine Learning algorithms and Artificial Intelligence methods are used, and some specific implementations were designed for the analysis, where each group was characterized by traditional statistical methods.

Primary Outcome Measures: Subphenotypes of acute kidney injury in patients, Number of acute kidney injury subphenotypes in patients with COVID-19, Through study completion, an average of one month
Secondary Outcome Measures: Mortality of acute kidney injury patients, Differences between mortality rates in acute kidney injury subphenotypes of patients with COVID-19, Through study completion, an average of one month|Severity of acute kidney injury patients, Differences between severity stages in acute kidney injury subphenotypes of patients with COVID-19, Through study completion, an average of one month|Non-recovery in acute kidney injury patients, Differences between non recovery rates in acute kidney injury subphenotypes of patients with COVID-19, Through study completion, an average of one month|Renal replacement therapy requirement in acute kidney injury patients, Differences between renal replacement therapy requirement rates in acute kidney injury subphenotypes of patients with COVID-19, Through study completion, an average of one month|Length of stay of acute kidney injury patients, Differences in-hospital length of stay in acute kidney injury subphenotypes of patients with COVID-19., Through study completion, an average of one month
Safety and Efficacy Evaluation of <Dovprela Tablets 200 mg> by Post-marketing Surveillance
NCT Number: NCT06471088
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Dovprela
Interventions: DRUG: Dovprela
Sponsor: Viatris Inc.
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-07-23
Completion Date: 2026-06-30
Locations: Viatris, Seoul, Korea, Republic of

Summary:
Dovprela Tablets (Pretomanid) is the only treatment approved for the treatment of drug-resistant tuberculosis on a wider scale.

This non-interventional post-marketing surveillance (PMS) study is one of the obligations that must be followed under the Ministry of Food and Drug Safety (MFDS). In accordance with the Pharmaceutical Affairs Act and the re-examination criteria for new drugs, etc. notified by the MFDS, this study will be conducted with the purpose to collect and review required information on the safety and efficacy of drugs requiring re-examination for appropriate use. Safety and efficacy information will be provided for a minimum of 100 subjects who receive treatment in general clinical settings for a period of 4 years following approval.

This survey is an open, non-comparative, non-interventional, prospective, multicenter study conducted by certified physicians (i.e., the investigator) at a Korean medical institution.

Primary Outcome Measures: Number of Participants With Adverse Events (AEs), AE refers to undesirable and unintended signs (e.g., abnormalities in laboratory examination values), symptoms, or diseases that occur during the administration or use of drugs, etc., and it does not necessarily mean that it will have a causal relationship with the corresponding drug., Baseline up to approximately 6 months