pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
A Study to Prospectively Validate Blood Markers Associated With Differences in Efficacy of Neoadjuvant Therapy for NSCLC
NCT Number: NCT06503042
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Non-small Cell Lung Cancer
Interventions: DRUG: Chemotherapy combined with immunotherapy|DRUG: Chemotherapy only
Sponsor: Tang-Du Hospital
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-01
Completion Date: 2026-08-01

Summary:
This study utilized a prospective cohort design. It is proposed to analyze the serum of NSCLC patients treated with chemotherapy combined with immunotherapy, and chemotherapy alone, starting from liquid biopsy technique and combining with proteomic methods. By comparing the differences in serum proteins between the two groups of patients before treatment, we will validate the targets related to efficacy and AE events identified in a previous retrospective study, further explore their associations with patients' clinical outcomes and AE events, and establish a clinical prediction model to guide and improve the current treatment of NSCLC.

Primary Outcome Measures: pCR rate, rate of pathological complete response, 4 months|MPR rate, rate of major pathologic response, 4 months
Secondary Outcome Measures: AE, Adverse Event, 4 months
Evaluate Cytotoxicity, Leaching, and Structural Conformation of Clear Aligners
NCT Number: NCT06503029
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Malocclusion|Cytotoxicity
Interventions: DEVICE: Invisalign Cleaning Crystals|DEVICE: Fittey Dent Cleaning Tablet|DRUG: Listeren Mouthwash|DEVICE: Toothbrush and Water
Sponsor: Riyadh Elm University
Sex: ALL
Age: ADULT
Enrollment: 84
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-07-15
Completion Date: 2025-03-05
Locations: Riyadh Elm University, Riyadh, 12611, Saudi Arabia

Summary:
The aim is to evaluate clear aligners' cytotoxicity, leaching, and structural properties and compare them with four cleaning tools. The null hypothesis is the cleansers have no impact on the properties tested.

Primary Outcome Measures: Cytotoxicity, Aligners from each of the four groups will be submerged in normal saline for a month at 37°C to conduct a cytotoxicity assessment. Following that, the solutions were diluted to three distinct concentrations (5%, 10%, and 20% volume/volume). After 48 hours of seeding in 96-well microplates, gingival fibroblasts were exposed to the solution, and the medium will be changed to an MTT solution (MTT: 3-\[4,5-dime-thylthiazol-2-yl\]-2,5-diphenyltetrazolium bromide). Then optical density will be measured to ascertain cell viability and subsequently assess cytotoxicity., 1-2month|Leaching, Each set of aligners from each of the four groups will be cut into 5x5 mm squares. To accelerate the degradation of the sample, each specimen will be submerged in a single glass vial with an alcoholic media. Each material will be soaked in five different solutions as follows: the first is absolute ethanol (100%), the second is 75% ethanol to 25% water, the third is 50% ethanol to water, the fourth is 25% ethanol to 75% water, and finally, 100% water solution served as the control.

A gas chromatography-mass spectrometry unit shall be used to analyze the leached substances in the immersion medium. An Agilent GC 7890A combined with a triple-axis detector 5975 C single quadrupole mass spectrometer will be used for GC-MS analysis, 1-2months|Structural Conformation, Maxillary and mandibular clear aligners from all four included groups will be cut into 5 × 5 mm squares. Each specimen will be mounted in a plastic mold using an orthodontic plaster to facilitate the indentation process. The microhardness will be tested using a Vickers indenter (INNOVATEST, FALCON 450, Deutschland GmbH) by applying a 25 gf load for 15 s., 1-2months
The Effect of phoSPHocreatine on mEdical Emergency Team (Met) tREated Patients
NCT Number: NCT06503016
Acronym: SPHERE
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Hypotension|Consciousness, Level Altered|Airway Disease|Respiratory Failure|Tachypnea|Bradypnea|Tachycardia|Bradycardia|Cardiac Failure|Cardiac Arrest
Interventions: DRUG: Phosphocreatine|DRUG: Placebo
Sponsor: Università Vita-Salute San Raffaele
Collaborators: Silvia Ajello
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 400
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-07
Completion Date: 2026-07

Summary:
Unexpected deaths and unplanned intensive care unit (ICU) admissions are common during hospital stay and are often preceded by warning abnormalities in patients' vital signs. These abnormalities trigger Medical Emergency Team (MET) activation and up to 15% of patients visited by the MET is admitted to the ICU with an overall hospital stay after the MET intervention of approximately 2 weeks. Phosphocreatine (PCr) is a natural energy-buffering molecule associated with signals of mortality reduction in patients with acute cardiac conditions (according to meta-analytic finding from our group) and with encouraging beneficial effects on other acute organ failures (e.g. brain). The investigators designed a multi-center, randomized, placebo-controlled trial to confirm the promising beneficial effects of PCr in hospitalized patients. The investigators expects a reduction in hospital stay (measured as an increase in days alive and out of hospital at 30 days) when PCr is added to standard treatment in patients requiring MET intervention.

Primary Outcome Measures: days alive and out of hospital at 30 days., To compare the effect of phosphocreatine (PCr) (experimental group), versus placebo (saline solution-control group) on the number of days alive and out of hospital at 30 days., day 30 or hospital discharge
Secondary Outcome Measures: Cognitive function, Evaluation of cognitive function using the Cognitive Telephone Screening Instrument (COGTEL). The COGTEL is a test that evaluates the cognitive performance of survived patients 30 days after randomization. This scale has a minimum of zero points and a maximum of 100., day 30|Rate of arrhythmia needing treatment, Clinically relevant arrhythmias will be recorded and confirmed by an ECG. Rate of major arrhythmias divided into supraventricular arrhythmias, ventricular arrhythmias, bradyarrhythmias, and need for antiarrhythmics will be registered., hospital discharge (which usually occurs in the 30days after randomization)|Rate of ICU admissions or criteria for ICU admission, ICU admission, hospital discharge (which usually occurs in the 30days after randomization)|Death at 30 days, Death, day 30|Death at 90 days, Death, 90 days
Study Evaluating Tarlatamab in Chinese Participants With Advanced Small Cell Lung Cancer After Two or More Prior Lines of Treatment
NCT Number: NCT06502977
Acronym: DeLLphi-307
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Advanced Small Cell Lung Cancer
Interventions: DRUG: Tarlatamab
Sponsor: Amgen
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-27
Completion Date: 2026-09-25

Summary:
The primary aim of this study is to evaluate the efficacy of tarlatamab as assessed by objective response rate (ORR) based on blinded independent central review (BICR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1).

Primary Outcome Measures: ORR Based on BICR per RECIST 1.1, Approximately 24 months
Secondary Outcome Measures: Duration of Response (DOR) Based on BICR per RECIST 1.1, Approximately 24 months|Disease Control (DC) Based on BICR per RECIST 1.1, Approximately 24 months|Duration of DC Based on BICR per RECIST 1.1, Approximately 24 months|Progression-free Survival (PFS) Based on BICR per RECIST 1.1, Approximately 24 months|ORR Based on Investigator Assessment per RECIST 1.1, Approximately 24 months|DOR Based on Investigator Assessment per RECIST 1.1, Approximately 24 months|DC Based on Investigator Assessment per RECIST 1.1, Approximately 24 months|Duration of DC Based on Investigator Assessment per RECIST 1.1, Approximately 24 months|PFS Based on Investigator Assessment per RECIST 1.1, Approximately 24 months|Overall Survival (OS), Approximately 24 months|Number of Participants Who Experience Treatment-emergent Adverse Events (TEAEs), Approximately 24 months|Serum Concentration of Tarlatamab, Approximately 24 months|Number of Participants with Anti-tarlatamab Antibody Formation, Approximately 24 months
Study of ALTO-101 in Patients With Schizophrenia
NCT Number: NCT06502964
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Schizophrenia|Cognitive Impairment
Interventions: DRUG: ALTO-101|DEVICE: ALTO-101 Transdermal Delivery System|DRUG: Placebo|DEVICE: Placebo Transdermal Delivery System
Sponsor: Alto Neuroscience
Sex: ALL
Age: ADULT
Enrollment: 72
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07
Completion Date: 2025-11
Locations: Site 5083, Garden Grove, California, 92845, United States|Site 5060, Hollywood, Florida, 33024, United States|Site 5056, Chicago, Illinois, 60640, United States|Site 5062, Gaithersburg, Maryland, 20877, United States|Site 5055, Cedarhurst, New York, 11516, United States

Summary:
This is a Phase 2, double-blind, placebo-controlled, two-way crossover study to compare the efficacy of ALTO-101T versus placebo in change in electroencephalogram (EEG) cognitive processing markers and measures of cognition.

Additional goals are to assess pharmacokinetic (PK), safety, and tolerability of the recently developed ALTO-101T transdermal delivery system (TDS) formulation in a patient population.

Primary Outcome Measures: Theta band activity, Theta band activity after 5 and 10 days of dosing of ALTO-101T compared to placebo., Treatment Period 1 - Day 6 and Day 11; Treatment Period 2 - Day 6 and Day 11
Secondary Outcome Measures: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] ALTO-101T compared to placebo, Incidence, severity, and relatedness of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and discontinuation due to TEAEs., Treatment Period Day 1 through study completion (an average of 36 days)
Manipulation and Dry Needling in Patients With Cervicogenic Headache and WAD II
NCT Number: NCT06502951
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cervicogenic Headache|Whiplash Injuries
Interventions: OTHER: Dry Needling,Thrust Manipulation|OTHER: Exercise,Non-thrust Mobilization
Sponsor: Alabama Physical Therapy & Acupuncture
Collaborators: Universidad Rey Juan Carlos
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 120
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-05-01
Completion Date: 2026-05-01
Locations: Alabama Physical Therapy & Acupuncture, Montgomery, Alabama, 36117, United States

Summary:
The purpose of this research is to compare two different approaches for treating patients with cervicogenic headaches associated with type II whiplash associated disorder: non-thrust mobilization and exercise versus thrust manipulation and dry needling. Physical therapists commonly use all of these techniques to treat cervicogenic headaches. This study is attempting to find out if one treatment strategy is more effective than the other.

Primary Outcome Measures: Change in Headache Intensity (Numeric Pain Rating Scale, 0-10) (Rating Score), Rating Score on 0-10 scale. Baseline score must exceed 2/10 to be included. Lower scores indicate less pain intensity.

the study., Baseline, 1 week, 4 weeks, 3 months
Secondary Outcome Measures: Change in Global Rating of Change Score for Headaches, Rating score for self perceived change with range of -7 to +7. Higher scores indicate greater improvement., 3 months|Change in Global Rating of Change Score for Neck Pain, Rating score for self perceived change with range of -7 to +7. Higher scores indicate greater improvement., 3 months|Change in Medication Intake (Frequency of medication intake in last week), Over the counter and prescription medication, Baseline, 3 months|Change in Headache Duration (Total hours of headaches in the last week), Total hours of headaches in the last week, Baseline, 1 week, 4 weeks, 3 months|Change in Headache Frequency (Number of headaches in the last week), Number of headaches in the last week, Baseline, 1 week, 4 weeks, 3 months|Change in Disability (Neck Disability Index, 0-50 points), 10 Questions each worth 0-5 points with maximum score of 50 points possible. Lower scores indicate lower disability levels. Baseline score must exceed 10/50 to be included in study., Baseline, 1 week, 4 weeks, 3 months|Change in Neck Pain Intensity (Numeric Pain Rating Scale, 0-10 points), Rating score 0-10 points. Lower scores indicate lower pain intensity. Baseline score must exceed 2/10 to be included, Baseline, 1 week, 4 weeks, 3 months|Change in Pain Catastrophizing Scale (0-52 points), 13 questions each worth 0-4 points with maximum score of 52 points. Lower scores indicate less pain catastrophizing., Baseline, 3 months
A Clinical Trial Evaluating the Pan-vascular Interventional Robotic System for Panvascularization Interventional Surgery
NCT Number: NCT06502938
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Percutaneous Coronary Intervention
Interventions: DEVICE: Pan-vascular interventional robotic system|PROCEDURE: Traditional artificial percutaneous coronary intervention
Sponsor: Shenzhen Institute of Advanced Biomedical Robot Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 159
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-15
Completion Date: 2025-12-15
Locations: Beijing Anzhen Hospital,Capital Medical University, Beijing, Beijing, 100000, China|The First Affiliated Hospital,Sun Yat-sen University, Guanzhou, Guandong, 510080, China|Linfen Central Hospital, Shanxi, Linfen, 041000, China|Shanghai Zhongshan Hospital, Shanghai, Shanghai, 200000, China|The Affiliated Hospital of Hangzhou Normal University, Hangzhou, Zhejiang, 310000, China

Summary:
The purpose of this prospective, randomized, open, parallel controlled, multicenter trial is to investigate the efficacy and safety of the pan-vascular interventional robotic system for percutaneous coronary intervention (PCI). Investigators will evaluate clinical success, technical success, and record intraoperative data (PCI time, total operating time, contrast agent dose, radiation exposure dose, etc.). All subjects were followed up on the day of surgery, before discharge and 1 month after surgery to observe the safety indicators.

Primary Outcome Measures: Clinical Success, Immediate postoperative angiography showed residual stenosis \< 30% and TIMI blood flow fraction Level 3., Immediate postoperative angiography|Clinical Success, No MACE occurred in hospital., Discharge or 48 hours post intervention, whichever comes first
Secondary Outcome Measures: Technical success rate, 1. PCI was assisted by the Pan-vascular Interventional Robotic System.
2. No unplanned complete conversion to artificial surgery occurred due to the inability to complete the delivery of the guide wire or balloon/stent catheter through the vessel with the test instrument as intended, or due to insufficient guide catheter support., Procedure|Radiation Exposure, Patient and Main operator radiation exposure dose recorded by portable radiation, Procedure|Fluoroscopy Time, Total Fluoroscopy Time during procedure will be captured., Procedure|Contrast agent dosage, The total amount of contrast agent used during the whole procedure., Procedure|Procedure Time, Defined as the time measured from the insertion of the hemostasis sheath until the removal of the guide catheter., Procedure|PCI time, Defined as the time measured from the insertion of the guide catheter until the removal of the guide catheter., Procedure|the Pan-vascular Interventional Robotic Systemt performance evaluation, The performance of the product was subjectively evaluated by the surgeon., After the operation
Association Between Iron Reserves and Perioperative Neurocognitive Disorders
NCT Number: NCT06502912
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Perioperative Neurocognitive Disorders
Interventions: OTHER: no intervention
Sponsor: Chinese PLA General Hospital
Sex: ALL
Age: OLDER_ADULT
Enrollment: 12984
Study Design: Observational Model: |Time Perspective: p
Start Date: 2014-01-01
Completion Date: 2021-12-31

Summary:
Iron metabolism disorder have been identified as the pivotal contributor in the pathogenesis and progression of perioperative neurocognitive disorders. However, the association between iron reserves and perioperative neurocognitive disorders risk remains elusive. This retrospective cohort study aimed to explore the impact of preoperative serum ferritin levels on the risk of postoperative delirium in elderly patients undergoing non-neurosurgical and non-cardiac procedures.

Primary Outcome Measures: Number of participants with postoperative delirium, Medical chart review was used for postoperative delirium determination in this study. The defining criteria were as follows: 1) delirium-related terms included in postoperative medical records or 2) postoperative record of delirium or psychotropic drugs treatment., Within the first seven days following surgery
CMR in Myocardial Infarction with Nonobstructive Coronary Arteries
NCT Number: NCT06502899
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Cardiac Magnetic Resonance|Myocardial Infarction with Nonobstructive Coronary Arteries|Strain|Extracellular Volume
Sponsor: The Affiliated Hospital of Xuzhou Medical University
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 387
Study Design: Observational Model: |Time Perspective: p
Start Date: 2019-01-01
Completion Date: 2024-07-09

Summary:
MINOCA is accompanied by a worse prognosis, which is related to the inability to clarify the etiology.CMR has been explicitly recommended by guidelines as an etiologic diagnostic tool for MINOCA. Although CMR-related parameters, such as strain and ECV, have been shown to be associated with prognosis in patients with myocardial infarction. However, the relationship between CMR-strain or ECV and MINOCA is unclear. The aim of this study was to investigate the characterization of CMR-strain or ECV in patients with MINOCA and the relationship with prognosis.

Primary Outcome Measures: Primary endpoint events included any cause, non-fatal infarction, stroke, or cardiac readmission., All patients were followed until June 30, 2024
Evaluation of The Stability of Orthodontic Treatment After First Premolar Extraction Using Combined Retention Protocol
NCT Number: NCT06502886
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Orthodontic Appliance Complication
Interventions: PROCEDURE: combined protocol of retention (bonded lingual retainer and vacuum formed retainers)|PROCEDURE: Bonded lingual retainer
Sponsor: Cairo University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 24
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-03-10
Completion Date: 2025-03-01
Locations: Faculty of oral and dental medicine, Cairo university, Cairo, 11553, Egypt

Summary:
The aim of this study is to compare between the stability of anterior and posterior segments in both arches using bonded lingual retainers versus a combined protocol of retention (bonded lingual retainer and vacuum formed retainers). The effect of different treatment changes achieved on the post-treatment stability will be studied in both groups.

Hypothesis: No difference between BR and BR+VFR regarding the stability of anterior segment alignment and posterior segment alignment and interdigitation

Primary Outcome Measures: Mandibular anterior segment alignment, Using 3D models, mandibular anterior segment alignment will be measured by little irregularity index, 6 months
Secondary Outcome Measures: Maxillary anterior segment alignment, Using 3D models, maxillary anterior segment alignment will be measured by little irregularity index, 6 months
Setting up a Cohort of Patients With Crohn's Disease and a Cohort of Patients Without Chronic Inflammatory Bowel Disease
NCT Number: NCT06502873
Acronym: ELITE
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Crohn Disease
Interventions: PROCEDURE: biological samples collection
Sponsor: Artialis
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 120
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-06-28
Completion Date: 2026-02-28
Locations: CHU de Liège, Liège, Belgium

Summary:
The objective of this study is to constitute cohorts of Crohn versus non-Crohn patients to identify (a) new biomarker(s) of intestinal dysbiosis associated with Crohn disease, and develop a prototype for assaying such marker(s) in blood.

Primary Outcome Measures: Number of patients recruited in each cohort, 60 patients in crohn cohort and 60 patients in control cohort, 18 months|number of faeces samples collected in each cohort, 60 patients in crohn cohort and 60 patients in control cohort, 18 months|Number of plasma samples collected in each cohort, 60 patients in crohn cohort and 60 patients in control cohort, 18 months|Number of biopsy samples collected in each cohort, 60 patients in crohn cohort and 60 patients in control cohort with 4 colonic biopsies/ patient, 18 months
The Role of Breastmilk and Serum Exosomes in Neonatal Jaundice Due to ABO Incompatibility
NCT Number: NCT06502847
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Neonatal Jaundice From Other Specified Causes|ABO Incompatibility|ABO Hemolytic Disease
Interventions: OTHER: Exosome profile study
Sponsor: Kanuni Sultan Suleyman Training and Research Hospital
Sex: ALL
Age: CHILD
Enrollment: 45
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-01
Completion Date: 2025-08-01

Summary:
Neonatal jaundice is a major global health issue that can lead to serious complications and even death if not promptly treated. ABO incompatibility is a common cause of pathological neonatal jaundice, but there are currently no specific tests to predict its severity or progression. This project aims to study the role of exosomes in the diagnosis and treatment of newborn jaundice, focusing on their impact on infants with ABO incompatibility. The study will take place at a reference neonatal intensive care unit, involving 45 infants. Serum and breast milk samples will be collected and analyzed to determine any relationships and possible correlations.

Primary Outcome Measures: Number of the participant who Need for Treatment, Association between the serum and breastmilk exosome and need for treatment due to ABO incompability, 12 months
Preferences of Israeli New Physiotherapists in Choosing Their Future Workplace
NCT Number: NCT06502821
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Workplace
Interventions: OTHER: questtionnaire
Sponsor: University of Haifa
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 500
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-15
Completion Date: 2025-07-15

Summary:
This study aim to create a multidimensional body of knowledge on the factors influencing physiotherapy graduates in Israel in choosing a workplace, satisfaction with the chosen framework, and intergenerational differences in these factors. In addition, to examine the relationship between the factors for choosing a professional career in physiotherapy and choosing a workplace

Primary Outcome Measures: choosing a profession, Rating reasons for choosing physical therapy as a profession. questionnaire with 16 statements, each statement will be evaluated on a scale from 1(not at all) to 4 (very much), baseline|choosing workplace, Rating reasons for choosing workplace. questionnaire with 22 statements, each statement will be evaluated on a scale from 1(not at all) to 4 (very much), baseline
Areal and Linear Comparison of Gingival Recession
NCT Number: NCT06502782
Acronym: agr
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Gingival Recession
Interventions: DIAGNOSTIC_TEST: digital assesment
Sponsor: Abant Izzet Baysal University
Sex: ALL
Age: ADULT
Enrollment: 128
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-11-12
Completion Date: 2024-04-12
Locations: Bolu Abant İzzet Baysal University, Bolu, 14030, Turkey

Summary:
Recent advances in digital technology have led to the emergence of precise methods for measuring gingival recession and tissue thickness. This study aimed to compare digital measurement methods and conventional periodontal probe measurements for the assessment of gingival recession influenced by the gingival phenotype.

This study involved 128 gingival recession sites from 28 systemically healthy patients aged 18-45 years. The participants were categorized into two groups on the basis of gingival thickness. The plaque index, gingival index, probing depth, clinical attachment level, gingival recession depth, and gingival recession width, and keratinized gingival thickness and width were measured using a manual periodontal probe and an intraoral optical surface scanner. Statistical analysis was performed with nonparametric tests because the data were not normally distributed. P\<0.05 indicated statistical significanct.

Primary Outcome Measures: keratinized gingival thickness, Keratinized gingival thickness refers to the vertical measurement of the gingival tissue that extends from the free gingival margin to the mucogingival junction, characterized by a keratinized epithelial layer which provides enhanced protection and stability to the underlying periodontal structures., Baseline|keratinized gingival width, Keratinized gingival width refers to the horizontal dimension of the gingival tissue that is keratinized, measured from the free gingival margin to the mucogingival junction., Baseline|Gingival recession depth, Gingival recession is the apical migration of the gingival margin away from the cemento-enamel junction (CEJ), resulting in the exposure of the root surface of a tooth., Baseline|Gingival recession width, Gingival recession width refers to the horizontal measurement from the exposed cemento-enamel junction (CEJ) to the apical point of the gingival margin, indicating the extent of root surface exposure., Baseline
Secondary Outcome Measures: Plaque index, The plaque index assesses the amount of dental plaque visible on the vestibular and lingual surfaces of all teeth, Baseline|Gingival index, This measurement is based on the presence or absence of bleeding on gentle probing, Baseline|Bleeding on probing, Bleeding, leading sign of inflammation inside the connective tissue, is a critical factor for pocket depth measurements, and with other variable factors prevents making reproducible measurements., Baseline|Periodontal pocket depth, A pathologically deepened gingival sulcus around a tooth at the gingival margin., Baseline|Clinical attachment level, CAL is calculated by subtracting the gingival margin level from the probing depth., Baseline
COPE, Maternal Competence, Maternal Mental Health, Parent-Infant Interaction and Preterm Neonates
NCT Number: NCT06502730
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Empowerment|Competence|Outcome|Interaction
Interventions: BEHAVIORAL: Creating Opportunities for Parent Empowerment (COPE) Program
Sponsor: Matrouh University
Collaborators: Alexandria University
Sex: ALL
Age: CHILD
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-01-25
Completion Date: 2024-09-15
Locations: Matrouh university, Mersa Matruh, Egypt

Summary:
The aim of the study is to:

- Evaluate the effect of creating opportunities for parent empowerment program on maternal sense of competence, mental health outcome and mother-infant interaction.

RESEARCH HYPOTHESES

* Mothers of preterm neonates who receive creating opportunities for parent empowerment program exhibit high level of competence than those who don't.
* Mothers of preterm neonates who receive creating opportunities for parent empowerment program exhibit less stress level than those who don't.
* Mothers of preterm neonates who receive creating opportunities for parent empowerment program exhibit high interaction than those who don't.

The mothers of preterm neonates will be assigned into two equal groups as follows:

* Study group (group II) mothers of preterm neonates who will receive COPE program.
* Control group (group I) mothers of preterm neonates who will not receive COPE program.

Primary Outcome Measures: Parenting Sense of Competency Scale (PSOC), This scale was developed by Gibaud-Wallston \& Wandersman, 1978, the Chinese version of the PSOC Scale (C-PSOC) to assess the mothers' sense of competence and satisfaction with parenting. The C-PSOC includes 17 items., 7 days|Modified Parental Stressor Scale (PSS): NICU, This scale was developed by (Miles et al. 1993). It is used to assess perceived stress of mothers with preterm infants during the NICU hospitalization of their infant. The PSS:NICU is a 50-item self-report scale that measures parental stress related to four dimensions of the NICU environment: sights and sounds in the NICU (5 items); the infant's appearance (21 items); staff behaviors and communication (13 items), and parent interaction with baby (11 items)., 7 days|Parent-Infant Interaction Observation (PIIO) Checklist:, It is an observational Scale developed by (Svanberg, et al., 2013), It is a screening tool for parent-infant interactions for infant aged from 0-6 months. It includes 13 interactional items such as: Infant positioning, eye contact, vocalizations, affect engagement and synchrony, warmth and affection, holding and handling, verbal commenting (mind- mindedness), attunement/ harmony to distress, bodily intrusiveness, expressed expectations, empathic understanding, responsive turn taking, and baby's self-soothing strategies., 7 days
Viome Precision Nutritional Programs to Improve Clinical Outcomes for Mental Health Disorders
NCT Number: NCT06502717
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Mental Health Issue|Depression|Anxiety
Interventions: COMBINATION_PRODUCT: VIOME Precision Nutrition Program
Sponsor: Viome
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 150
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-07
Completion Date: 2025-12
Locations: Viome Life Sciences, Bothell, Washington, 98011, United States

Summary:
US residents who have mental health issues sign the informed consent form and are screened and enrolled for this study. Participants complete a survey upon enrollment and are randomized into one of two study arms. This study is direct to participant and will NOT utilize clinical sites.

Primary Outcome Measures: Reduced PHQ-9 Score, Reduced PHQ-9 score for the VPNP group compared to baseline scores., ~4 months|Reduced GAD-7 Score, Reduced GAD-7 score for the VPNP groups compared to baseline scores., ~4 months|Reduced Perceived Stress Scale Score, Reduced Perceived Stress Scale score for the VPNP group compared to baseline scores., ~4 months|Increased Quality of Life Score, Increased quality of life score for the VPNP group compared to baseline scores., ~4 months|Correlation between microbial changes and clinical outcomes, Correlation between microbial changes on the VPNP with clinical outcomes., ~4 months
[18F]FTT Positron Emission Tomography for the Measurement of PARP Tumor Expression in Patients With Metastatic Breast Cancer
NCT Number: NCT06502691
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Anatomic Stage IV Breast Cancer AJCC v8|Metastatic Breast Carcinoma
Interventions: OTHER: Best Practice|PROCEDURE: Biopsy of Breast|PROCEDURE: Computed Tomography|OTHER: Electronic Health Record Review|OTHER: Fludeoxyglucose F-18|RADIATION: Fluorine F 18 Fluorthanatrace|DRUG: Immune Checkpoint Inhibitor|DRUG: Poly (ADP-Ribose) Polymerase Inhibitor|PROCEDURE: Positron Emission Tomography|PROCEDURE: Positron Emission Tomography
Sponsor: University of Washington
Collaborators: Breast Cancer Research Foundation
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 22
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-12-01
Completion Date: 2029-12-31
Locations: Fred Hutch/University of Washington Cancer Consortium, Seattle, Washington, 98109, United States

Summary:
This clinical trial studies how well fluorine F 18 fluorthanatrace (\[18F\]FTT) positron emission tomography (PET) works in imaging patients with breast cancer that has spread from where it first started (primary site) to other places in the body (metastatic) who are receiving standard of care (SOC) poly (ADP-ribose) polymerase (PARP) inhibitors with or without immune checkpoint inhibitors (ICI) to be able to detect clinical response to PARP inhibitor ± ICI treatment. \[18F\]FTT is a radiotracer that targets and binds to PARP1 which can potentially be used for the imaging of PARP1 expression using PET. Once administered, \[18F\]FTT targets and binds to PARP1. Upon PET, PARP1-expressing tumor cells can be visualized. PET is an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of tracer, in the case, \[18F\]FTT. Because some cancers take up \[18F\]FTT it can be seen with PET. PARP inhibitors work as a targeted therapy by blocking an enzyme involved in repairing cell damage. It may cause tumor cells to die. ICI may help the body's immune system attack the cancer and may interfere with the ability of tumor cells to grow and spread. Combining \[18F\]FTT with a PET scan may help detect tumor cells better in patients with metastatic breast cancer who are receiving standard of care PARP inhibitors with our without ICI treatment.

Primary Outcome Measures: Overall response rate (ORR), Will be assessed using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria on poly (ADP-ribose) polymerase (PARP) inhibitor ± immune checkpoint inhibitor (ICI) treatment. Will use a boxplot to illustrate the difference of standard uptake value (SUV)max and SUVmean between responders and non-responders., Baseline up to 6 months
Secondary Outcome Measures: ORR, Will be assessed using RECIST 1.1 criteria on PARP inhibitor ± ICI treatment. Will use the nonparametric method Wilcoxon Rank Sum test to evaluate the difference of the changes of SUVmax and/or SUVmean between responders and non-responders., Baseline up to 6 months
AUTOANTIBODIES AND SYSTEMIC SCLEROSIS
NCT Number: NCT06502678
Acronym: AUTO
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Understand Pathogenicity of SSc-specific Antibodies in SSc and the Effect of Antibody Blockade in Vitro
Interventions: BIOLOGICAL: Fcr blocker of autoantibodies
Sponsor: IRCCS Ospedale San Raffaele
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 6
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-01
Completion Date: 2025-12-31

Summary:
Established in vitro assays, combined with state-of-the-art multi-omics approaches and innovative in vitro experimental models, will gain insights into the mechanistic bases underlying Systemic Sclerosis (SS) pathogenesis and will dissect the consequences of treatment with Efgartigimod on functional and phenotypic cell behaviors. Healthy microvascular endothelial cells, fibroblasts and monocytes will be challenged with serum and autoantibodies prior to or upon treatment with Efgartigimod in order to assess both the prevention and the recovery capacity of the FcR blocker. The putative modulatory effect of Efgartigimod on vascular remodeling, endothelial-to-mesenchymal transition, fibroblast-to-myofibroblasts transition and monocyte behavior will be evaluated in in-vitro consolidated assays. Integrated Omics analyses will support and complement the in vitro findings by unveiling potential prognostic signatures and by identifying specific treatment-related profiles that might guide the modulation of the drug usage in order to maximize its beneficial effects.

Primary Outcome Measures: Verify if Fcblocker can block the pathogenic activity of autoantibodies, To assess both the prevention and the recovery capacity of the FcR blocker in different kind of cells submitted to the specific autoantibody. microvascular endothelial cells and fibroblasts, 24 months
Second Ovulation Induction
NCT Number: NCT06502665
Status: ACTIVE_NOT_RECRUITING
Study Type: OBSERVATIONAL
Conditions: IVF|Infertility
Interventions: OTHER: Women having had second ovulation induction after failed oocyte pick-up
Sponsor: Clinique Ovo
Sex: FEMALE
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 87
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-04
Completion Date: 2024-07-30
Locations: Clinique Ovo, Montréal, Quebec, H4P 2S4, Canada

Summary:
Studies reported various risk factors for inadequate ovulation induction such as body mass index, low ovarian reserve, low baseline FSH and LH, and previous use of contraception or agonist.

The flexibility to use human chorionic gonadotropin (hCG) or gonadotropin-releasing hormone agonist (GnRHa) in ovulation induction for antagonist protocol or progestin primed ovarian stimulation (PPOS) is an advantage helping fertility doctors to decrease the risk of ovarian hyperstimulation syndrome. However, luteinizing hormone (LH) levels \<15UI/L and progesterone ≤11.13nmol/L eight to twelve hours post GnRHa trigger were highly correlated to failed oocyte pickup (FOP).

Rescue hCG have been found to increase favorable outcomes in patients with FOP. The presence of false FOP could be due pharmaceutical reasons and human error. Genuine FOP could be due to intrinsic ovarian pathology.

The FOP is defined as the absence of oocytes after ovarian stimulation and follicular aspiration. It is an uncomfortable situation for the patient and medical team to deal with due to the apparent expectations of favorable results.

Ovulation induction could be via GnRHa, HCG, or both in antagonist protocol and PPOS protocol. Long or short agonist protocol could be triggered only via HCG.

Primary Outcome Measures: Oocyte pick-up at retrieval, Number of retrieved oocytes after second ovulation induction in patients with FOP, 36 hours after ovulation triggering
Secondary Outcome Measures: Timing of ovulation triggering, Time interval outcomes between trigger and ovum pickup, 24 to 36 hours after ovulation triggering
Effects of Sprint Interval Training on Field Hockey Players.
NCT Number: NCT06502626
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Sports Physical Therapy
Interventions: OTHER: Regular training|OTHER: Sprint Interval Training
Sponsor: Riphah International University
Sex: ALL
Age: ADULT
Enrollment: 28
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: OTHER
Start Date: 2023-02-15
Completion Date: 2024-08-25
Locations: Pakistan sports Academy, Lahore, Punjab, 52254, Pakistan

Summary:
Field hockey is a team sport that is played using sticks and balls. Player's motions are impromptu and determine how competitive matches are played. Athletes can enhance their performance through a variety of training regimens. "Sprint Interval Training," for short bursts of maximal or supramaximal exercise, is one type of training used to improve sports performance. During recovering intervals, participants alternate between passive rest or light to moderately hard work. In both skilled and novice players, Sprint interval training significantly increases anaerobic and aerobic performance. This study aims to determine the impact of sprint interval training on hockey player's running performance, speed, and direction changes.

Primary Outcome Measures: Speed, It will be assessed by 20m sprint test, values will be taken before and after the application of sprint interval training for the participants of both groups., 10 months|Change of direction, It will be assessed by 505 Change of direction test, values will be taken before and after the application of sprint interval training for the participants of both groups., 10 months|Running performance, It will be assessed by 3000m time trial, values will be taken before and after the application of sprint interval training for the participants of both groups., 10 months
Idiopathic Scoliosis New Onset and Melatonin Phase Delay in Children
NCT Number: NCT06502613
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Scoliosis Idiopathic|Circadian Rhythm|Melatonin
Sponsor: Second Affiliated Hospital of Wenzhou Medical University
Sex: ALL
Age: CHILD
Enrollment: 956
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-01
Completion Date: 2027-07-15
Locations: The Second Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, 325000, China

Summary:
This study aimed to investigate the prevalence and clinical significance of melatonin phase delay in children with new onset and progressive idiopathic scoliosis (IS).

Primary Outcome Measures: Scoliosis Curve Angle, A long standard standing whole spine radiograph will be used for measuring curve size in terms of Cobb angle according to the standard Cobb method, Routine follow-up visits will be scheduled 6 months apart up to 36 months|Angle of Trunk Rotation, In addition to spinal X-rays, a Scoliometer can also help monitor curve progression. The Scoliometer is an inclinometer that measures the asymmetries between the sides of the trunk by measuring axial rotation in degrees. Numerous studies have found a high correlation between trunk axial rotation (ATR) values and the Cobb angles., Routine follow-up visits will be scheduled 6 months apart up to 36 months
Secondary Outcome Measures: Circadian rhythm Measurements, circadian rhythm as assessed by Morning and Evening Questionnaire-5 (MEQ-5), Baseline|Body mass index, Changes in height, weight and body mass index, Routine follow-up visits will be scheduled 6 months apart up to 36 months|Sleep quality, The Pediatric Sleep Questionnaire (PSQ) is used to assess sleep quality, Baseline|Sleep quality, The Pittsburgh Sleep Quality Index (PSQI) is used to assess sleep quality, Baseline
Factors Affecting Surgical Recovery in Hospital Patients
NCT Number: NCT06502600
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Hospitalized Surgical Patients
Interventions: PROCEDURE: surgery time|PROCEDURE: surgeon|PROCEDURE: surgical procedure duration|PROCEDURE: operating room|PROCEDURE: type of surgery
Sponsor: Second Affiliated Hospital of Wenzhou Medical University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 600
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-01
Completion Date: 2025-12-31
Locations: The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University,, Wenzhou, Zhejiang, 325027, China

Summary:
The objective of this observational study is to elucidate the factors influencing adverse postoperative outcomes in hospitalized surgical patients. The primary questions addressed are:

What factors contribute to the occurrence of adverse outcomes following surgery? How can the risks be mitigated to achieve improved postoperative outcomes?

Primary Outcome Measures: Death, 1 year
Self-Care Management in Older Adults
NCT Number: NCT06502574
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Disease Self Management
Interventions: OTHER: mobile application
Sponsor: Sultan Ayaz Alkaya
Collaborators: Health Institutes of Türkiye (TUSEB)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 72
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-07-20
Completion Date: 2025-06-30

Summary:
Self-management of chronic diseases requires the ability to manage the symptoms, treatment, and lifestyle changes inherent in living with achronic disease. Rational drug use by older adults is of particular importance. Mobile applications are being developed to facilitate thecompliance of older adults with chronic diseases with medication treatment and to increase their disease self-management skills. The researchwas planned to strengthen participation in social life through rational drug use and disease self-care management in older adults with chronicdiseases. The research will be conducted in a parallel group randomized controlled manner. In the research, a mobile application will bedeveloped for the use of older adults. Older adults will be asked to use the mobile application for at least 6 months, and the scales will be re-administered face to face or online in the 3rd and 6th months of the intervention.

Primary Outcome Measures: Participation in social life (Social Inclusion Scale), It was developed in 2009 by Secker et al. to measure an individual's relationship with other people. A validity and reliability study of theTurkish version of the scale was conducted. 4 items were removed from the original 22-item scale and the final version consisted of 18items. The lowest and highest that can be taken from the scale are 18 and 72. A higher score from the scale indicates more socialization., Baseline|Participation in social life (Social Inclusion Scale), It was developed in 2009 by Secker et al. to measure an individual's relationship with other people. A validity and reliability study of theTurkish version of the scale was conducted. 4 items were removed from the original 22-item scale and the final version consisted of 18items. The lowest and highest that can be taken from the scale are 18 and 72. A higher score from the scale indicates more socialization., within first week]|Participation in social life (Social Inclusion Scale), It was developed in 2009 by Secker et al. to measure an individual's relationship with other people. A validity and reliability study of theTurkish version of the scale was conducted. 4 items were removed from the original 22-item scale and the final version consisted of 18items. The lowest and highest that can be taken from the scale are 18 and 72. A higher score from the scale indicates more socialization., twelfth week]