pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Anastomotic Leaks in Esophageal Squamous Cell Carcinoma Patients After Trimodal Therapy
NCT Number: NCT06556355
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Anastomotic Leak Esophagus
Interventions: OTHER: neoadjuvant chemoradiation and McKeown esophagectomy
Sponsor: Qiaoqiao Li
Collaborators: Chinese Institute of Food Science and Technology
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 218
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-11-01
Completion Date: 2023-09-15
Locations: Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, 510060, China

Summary:
To investigate the clinical factors and preoperative treatment to the future anastomotic location of cervical esophagus that were correlated with anastomotic leaks in esophageal squamous cell carcinoma patients undergoing neoadjuvant chemoradiation and McKeown esophagectomy and to explore the prognosis of anastomotic leak.

Primary Outcome Measures: anastomotic leak rate, According to the consensus on standardization of data collection for complications associated with esophagectomy by the Esophagectomy Complications Consensus Group (ECCG), anastomotic leak was defined as a full-thickness gastrointestinal defect involving the esophagus, anastomosis, staple line or conduit, which was diagnosed as extravasation of water-soluble contrast during a swallow study, postoperative esophageal barium X-ray or CT scan, visualization of anastomotic dehiscence or leak during endoscopy, or salivary fluid in the cervical region., Up to 1 month
Secondary Outcome Measures: Overall survival, Overall survival (OS) was defined as the duration from the date of pathological diagnosis to the date of death or censoring., From date of pathological diagnosis until the date of death from any cause or censoring, assessed up to 36 months
Other Outcome Measures: Pathologic complete response, Pathologic complete response (pCR) was defined as no evidence of residual tumor cells in the primary tumors and resected lymph nodes of the operative specimens., Up to 1 month
Acupressure and Sleep Quality of Nursing Students
NCT Number: NCT06556303
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Poor Quality Sleep
Interventions: OTHER: Acupressure
Sponsor: University of Gaziantep
Sex: ALL
Age: ADULT
Enrollment: 53
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2022-04-01
Completion Date: 2022-06-30
Locations: Gaziantep Unıversty, Gaziantep, Sehitkamil, 27000, Turkey

Summary:
This randomised, controlled and experimental study was conducted between 15 April and 15 June 2022 to examine the effect of acupressure on sleep quality of fourth-year nursing students. The population of the study consisted of all fourth-year nursing students and the sample consisted of 53 students who met the inclusion criteria. Approval from the ethics committee, permission from the institution and consents from the students were obtained before the research. The participants were assigned to intervention (n=26) and control (n=27) groups by simple random sampling method. The students in the intervention group were subjected to acupressure on the right and left sides of Shenmen (HT7) acupuncture point of the heart meridian, Sanyinjiao (SP6) acupuncture point of the spleen meridian, Neiguan (PC6) acupuncture point of the pericardium point, and Tian-Zhu (BL10) acupuncture point of the neck. The researcher having the certificate practised acupressure on each point for two minutes each, totalling 16 minutes, three days a week for four weeks. A questionnaire and the Pittsburgh Sleep Quality Index (PSQI) were applied at the beginning of the study, and the PSQI was applied again at the end of the fourth week. Total score of the PSQI ranges from 0 to 21. A total score higher than five indicates poor sleep quality. It was found that the PSQI total mean score of the intervention group dropped from 8.53±2.45 to 6.38±3.64, while the PSQI total mean score of the control group decreased from 9.40±1.62 to 8.40±3.48 (p\<0.05). Also, subjective sleep quality, sleep disturbances and daytime dysfunction significantly decreased in the intervention group (p\<0.05).

Primary Outcome Measures: Change in sleep during the Follow-up, This scale consists of seven subscales (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbance, use of sleep medication and daytime dysfunctions) and 19 items. The sum of all subscales is assessed with a total sleep quality score ranging from 0 to 21. A total score higher than five indicates poor sleep quality, one mounth
Effect of a Casein and Gluten Free Diet in Mexican Children With Autism Spectrum Disorder
NCT Number: NCT06556290
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Autism Spectrum Disorder
Interventions: OTHER: Gluten free and casein free diet
Sponsor: University of Guadalajara
Sex: ALL
Age: CHILD
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-02-12
Completion Date: 2025-07-31
Locations: Centro Universitario de Ciencias de la Salud, Universidad de Guadalajara, Guadalajara, Jalisco, 44340, Mexico

Summary:
Assess the effect of a casein-free and gluten-free diet on gastrointestinal symptoms, clinical variables, and the composition of the intestinal microbiota in Mexican children with autism spectrum disorder.

Primary Outcome Measures: Gut microbiota composition through Next Generation Sequencing (16SRNA) and bioinformatic analysis, The composition of the intestinal microbiota will be sequenced, and gastrointestinal symptoms will be characterized before and after the nutritional intervention., 12 weeks
Immunologic Impact of Dupilumab in Patients Suffering From Asthma and Chronic Rhinosinusitis With Polyps
NCT Number: NCT06556264
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Chronic Rhinosinusitis With Nasal Polyps|Asthma
Interventions: DRUG: Dupilumab|OTHER: Placebo
Sponsor: Dr. Andrew Thamboo, MD
Collaborators: Sanofi
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2025-12

Summary:
The investigators are studying adults who have chronic rhinosinusitis with nasal polyps (CRSwNP) and moderate to severe asthma, and who are undergoing Endoscopic Sinus Surgery (ESS). Investigators want to understand how adding a medication called dupilumab to their usual treatment affects inflammation in their upper and lower airways over 24 weeks.

Dupilumab works by blocking certain signals in the immune system that contribute to inflammation in both the sinuses and the lungs. By studying how this medication changes the immune profiles of both airway systems, investigators hope to learn more about the underlying causes of airway inflammation in these conditions.

This research is important because it may help understand if treating inflammation in one part of the airway (like the lungs) has a similar effect on inflammation in another part (like the sinuses). This could lead to better treatments for people with CRSwNP and asthma, targeting the root causes of their symptoms more effectively.

Primary Outcome Measures: Change in Cytokine levels such as GM-CSF, IFNg, TNFa, VEGF-A, Identification of Key Interleukins and chemokynes (10/CXCL10, MIP-1a/CCL3, RANTES/CCL5), compared with placebo in CRSwNP and asthma patients from baseline to week 24, Change in GM-CSF, IFNg, IL-1b, IL-2, IL-4, IL-5, IL-6, IL-8, IL-10, IL-12 (p40), IL-13, IL-17A, IP-10/CXCL10, MIP-1a/CCL3, RANTES/CCL5, TNFa, VEGF-A compared with placebo in CRSwNP and asthma patients from baseline to week 24, From baseline to 24 weeks.
Secondary Outcome Measures: Changes in SNOT-22, ACQ-5 and Sniffin Stick Test, Relation of changes in the inflammatory profiles with changes in symptom control (SNOT-22, ACQ-5,Sniffin Stick test) compared with placebo at baseline and 24 weeks., 24 weeks|Relation of changes in inflammatory profile with changes in endoscopic scores (MLK), Correlate the changes in the inflammatory profiles with changes in endoscopy scores (MLK scores) compared with placebo at baseline and 24 weeks., 24 weeks|Relation of inflammatory profile and (FeNO and nasal FeNO), Correlate the changes in the inflammatory profiles with changes in the pulmonary function measured by spirometry FEV1 values and standard and nasal fractional exhaled nitric oxide (FeNO and nasal FeNO) compared with placebo at baseline and 24 weeks, 24 weeks
Isolated Maxillary Sinus Lesions in Sohag University Hospital
NCT Number: NCT06556225
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Maxillary Sinus Disease
Sponsor: Sohag University
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-04-10
Completion Date: 2025-01-01
Locations: Sohag Universty, Sohag, Egypt

Summary:
Aim of the study:

Identify variants of maxillary sinus pathologies, its clinical presentations, radiological findings and surgical managements.

Primary Outcome Measures: Identify variants of maxillary sinus pathologies, its clinical presentations, radiological findings and surgical managements., All the collected data will be analyzed using the Statistical Package for Social Sciences (SPSS) (SPSS Inc., Chicago, IL, USA)v22., will be at Sohag University Hospital, a tertiary care academic center in Egypt, from 2023 to 2024
A Study of Selinexor in Combination With Temozolomide and Anti-PD-1 Antibody in Patients With Relapsed/Refractory Primary Central Nervous System Lymphoma
NCT Number: NCT06556199
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Relapsed/Refractory Primary Central Nervous System Lymphoma
Interventions: DRUG: Selinexor|DRUG: Temozolomide|DRUG: Anti-PD-1 monoclonal antibody
Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 38
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-31
Completion Date: 2028-08-31
Locations: 2nd Affiliated Hospital, School of Medicine, Zhejiang University, Hanzhou, Zhejiang, 310009, China

Summary:
This study is a prospective, single-arm, open label, Phase Ib/II clinical study to evaluate the safety and efficacy of selinexor in combination with temozolomide and anti-PD-1 monoclonal antibody in patients with relapsed/refractory primary central nervous system lymphoma(PCNSL). Phase Ib used a "3+3" dose-climbing design to confirm the safety, maximum-tolerated dose (MTD,if any) and recommended phaseII dose (RP2D) of selinexor in combination with fixed dose of temozolomide and anti-PD-1 monoclonal antibody for 6 cycles. Phase II was a comprehensive evaluation of efficacy and safety. Subjects who achieved complete remission or partial remission were treated with anti-PD-1 monoclonal antibody maintenance therapy until disease progression or recurrence, intolerance of toxicity, death, loss of follow-up, withdrawal of notification (whatever happened first).

Primary Outcome Measures: Recommended phase 2 dose, To determine the recommended phase 2 dose for Selinexor., Up to 21days|Objective response rate (ORR) for Phase II study, The objective response rate (ORR) is defined as the proportion of patients with CR or PR at the end of induction treatment., 18 weeks
Secondary Outcome Measures: Progression-free survival (PFS), PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first., Up to 2 years after enrollment|Overall survival (OS), OS is defined as the duration of time from start of treatment to time of death., Up to 2 years after enrollment|Duration of response, The duration of overall response is measured from the time achieving ORR to time of progression, relapse or death, whichever occurs first., Up to 2 years after enrollment
Other Outcome Measures: ctDNA mutation and mean ctDNA concentration in serum and cerebrospinal fluid, Types of ctDNA mutations and frequency are measured by next generation sequencing. The mean ctDNA concentration is the concentration of ctDNA expressed as mean tumor molecules /ml at specific time points., Up to 2 years after enrollment|The levels of cytokine concentration in serum and cerebrospinal fluid, The levels of cytokine will be analyzed by ELISA in all patients recruited at Baseline and specific time point. The cytokine profile includes IL-6, IL-10, TNF-α, IFN-γ, IL-2 and IL-4, Up to 2 years after enrollment
Surgical and Pharmacological Efficacy of Knosp Grade 0-2 Prolactinoma
NCT Number: NCT06556186
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Pituitary Tumor
Interventions: PROCEDURE: Transnasal transsphenoidal pituitary lesion resection under neuroendoscopy|DRUG: Bromocriptin 2.5mg, 2-3 times a day
Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators: Peking Union Medical College Hospital|West China Hospital|First Affiliated Hospital of Wenzhou Medical University|Ningbo Medical Center Lihuili Hospital
Sex: ALL
Age: ADULT
Enrollment: 600
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-10-01
Completion Date: 2027-03-31

Summary:
The investigators carried out a multi-center comparative study, involving hospitals including the Second Affiliated Hospital of Zhejiang University School of Medicine, Peking Union Medical College Hospital, West China Hospital, Wenzhou First Hospital, and Li Huili Hospital. This study aimed to compare the efficacy of medication and surgery for specific subtypes of microadenomas and clearly defined macroadenomas (Knosp grades 0-2), in order to determine which is more effective and which has fewer benefits, thereby enhancing the evidence base.

Primary Outcome Measures: pituitary hormone levels, Recheck pituitary hormones (PRL, GH, ACTH, etc.), At 1, 3, 6, 9 and 12 months postoperatively|pituitary MRI, Recheck pituitary MRI, At 1,6 and 12 months postoperatively
Secondary Outcome Measures: sexual function evaluation, Male:International Index of Erectile Function (IIEF-5); Female:Female Sexual Function Index (FSFI), At 1,6 and 12 months postoperatively|menstrual condition, There is currently no specific "Pituitary Tumor Menstrual Status Questionnaire" for evaluation. The investigators usually evaluate the impact of pituitary tumors on menstruation based on the participants clinical symptoms and the results of sex hormones, At 6 and 12 months postoperatively|lactation, Serum prolactin levels, At 1,6 and 12 months postoperatively
Phase 2a Study of VTX3232 in Parkinson's Disease
NCT Number: NCT06556173
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Idiopathic Parkinson Disease
Interventions: DRUG: VTX3232
Sponsor: Zomagen Biosciences, Ltd
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 10
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2025-03
Locations: Local Site #840001, New Haven, Connecticut, 06510, United States

Summary:
This is a study to understand if taking VTX3232 is safe in participants diagnosed with early stage idiopathic Parkinson's Disease (PD). Approximately 10 patients will take VTX3232 Dose A.

The study consists of a 30-day Screening Period (to see if a participant qualifies for the study), a 7-day Pre-Baseline Period, a 28-day Open Label Treatment period (a participant receives active Dose A), and a 14-day Follow-Up Period.

Primary Outcome Measures: Adverse Event (AE) / Serious Adverse Event (SAE) Incidence Rate and Severity through study completion, Incidence of AEs and SAEs, Day 1 of treatment period through study completion, up to 6 weeks
Secondary Outcome Measures: Pharmacokinetics (PK) of VTX3232 in plasma and Cerebrospinal Fluid (CSF) at Day 28, Concentration of VTX3232 in plasma and CSF through 28 days of study treatment, Day 1 of treatment period to Day 28 of treatment period
Fundamental and Clinical Study of Cochlear Synaptopathy
NCT Number: NCT06556160
Acronym: FunCoSy
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Hearing Loss
Interventions: PROCEDURE: near field recording of human auditory nerve activity during retro sigmoid approach with contact electrode
Sponsor: CHU de Reims
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2023-03-21
Completion Date: 2027-05-21
Locations: Damien JOLLY, Reims, France

Summary:
In humans, surface electrophysiological recording of the cochlear nerve in response to a sound stimulus provides information about the integrity and function of synapses (synaptic transmission) and nerve fibre function. However, this information remains global. The investigators have preliminary data showing that it is possible to extract and characterise the functional properties of nerve fibres during otoneurosurgery in humans, and therefore to isolate the neuronal sub-populations mentioned above more precisely than is currently possible. The use of these electrophysiological data from near-field recordings, i.e. in contact with the nerve, will enable the design and improvement of a mathematical model of the human cochlea. This model will provide access to the individual responses of each nerve fibre and fill the current gap in knowledge between the functioning of these fibres and global surface recordings.

Primary Outcome Measures: In response to a stimulus, the neurophonic potential recorded in the form of a wave called PSTR will be characterised patients defined as normo and hearing loss based on preoperative audiometric tests, During ponto cerebellum retro sigmoide surgery. In response to a stimulus, the neurophonic potential recorded in the form of a wave called PSTR will be characterised patients defined as normo and hearing loss based on preoperative audiometric tests by the following indices:- the amplitude of the peak- the amplitude of the plateau- the peak to plateau ratio- the time constant for the rapid decay of the peak- the time constant for the slow decay of the peak., At 48 months|Compare the amplitude and spectrum of global evoked auditory nerve activity with basic stimuli between patients defined as normo and hearing loss based on preoperative audiometric tests, During ponto cerebellum retro sigmoide surgeryelectrocochleography and distortion products., At 48 months
Secondary Outcome Measures: compare the primary objective with the results obtained with a mathematical model of the human cochlea in order to improve the responses of our model., During ponto cerebellum retro sigmoide surgery, At 48 months
Oral Liposomal Iron Versus Injectable Iron Sucrose for Anemia Treatment in Non-Dialysis Chronic Kidney Disease Patients
NCT Number: NCT06556134
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Anemia of Chronic Kidney Disease
Interventions: DRUG: Intravenous Iron Sucrose|DRUG: Oral Iron
Sponsor: Centre Hospitalier Hassan II - Fès
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 27
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2021-07-01
Completion Date: 2024-01-10
Locations: Nephrology, Dialysis, and Transplantation, Hassan II University Hospital, Fès, Fès-Meknes, 30050, Morocco

Summary:
This study aims to assess the comparative effects of intravenous and liposomal oral iron on hemoglobin levels in non-dialysis CKD patients. Additionally, it seeks to evaluate the rate of hemoglobin correction, iron reserve status during treatment, and therapeutic tolerance to these interventions.

Primary Outcome Measures: Hemoglobin elevation and its correction speed, Clinical guidelines define a target hemoglobin range that indicates successful correction. Hemoglobin is measured in g/dL., Assessments were conducted at baseline (Month 0) and during all subsequent follow-up visits at months 1 (Month 1), 2 (Month 2), and 3 (Month 3), as well as the 2 months following the drug discontinuation (Month 4) and (Month 5)
Secondary Outcome Measures: Ferritin serum levels, Ferritin levels, measured in ng/mL, serve as a reliable indicator of the body's iron reserves, reflecting overall iron storage., Assessments of ferritin levels were conducted at baseline (Month 0) and during all subsequent follow-up visits at months 1 (Month 1), 2 (Month 2), and 3 (Month 3), as well as the 2 months following the drug discontinuation (Month 4) and (Month 5)|Transferrin saturation, Transferrin saturation, expressed as a percentage (%), is a reliable indicator of iron availability in the body. The combination of ferritin levels (ng/mL) and transferrin saturation (%) provides the most reliable assessment of the body's iron status, offering a comprehensive view of both iron storage and availability., Assessments of transferrin saturation were conducted at baseline (Month 0) and during all subsequent follow-up visits at months 1 (Month 1), 2 (Month 2), and 3 (Month 3), as well as the 2 months following the drug discontinuation (Month 4) and (Month 5)
Saddle Block With IT Morphine for Penile Inversion Vaginoplasty
NCT Number: NCT06556121
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Pain, Postoperative
Interventions: PROCEDURE: Saddle block|PROCEDURE: pudendal nerve block
Sponsor: Women's College Hospital
Sex: MALE
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2025-12

Summary:
Penile Inversion Vaginoplasty (PIV) is a transition-related surgery (TRS) that is associated with severe postoperative pain. The optimal pain management strategies for this surgery remain unknown. We hypothesized that the addition of a saddle block with intrathecal morphine would yield clinically important analgesic benefits.

Primary Outcome Measures: Cumulative opioid (analgesic) consumption, Consumption intra-operatively, total in-hospital postoperative consumption measured oral morphine equivalents (MEQ), 48 hours
Secondary Outcome Measures: Time to first analgesic request, At recovery room discharge and hospital discharge, 24 hours|Pain Assessment (VAS), Visual Analogue Scale(VAS) - Pain:Overall pain assessed at rest and on movement A continuous scale comprised of a 100mm (10cm) horizontal line, anchored by 2 verbal descriptions No Pain to Worst Pain, Up to 48 hours post-operatively|Incidence of opioid-related side effects, Itching, respiratory depression, hypotension, nausea and vomiting, Up to 48 hours post-operatively|Presence of Block-related complications, Persistent paresthesia, post dural puncture headache, Up to 48 hours post-operatively|Quality of Life scores, Quality of Recovery (QR15) scores at 48 hours will be the second primary outcome.

QR15 is a measurement of quality of recovery after surgery and anesthesia that has been psychometrically tested and validated. Reporting of outcome measures on a scale of 0 to 10 (0=None of the time and 10=All of the time). There are a total of 40 items/questions., 48 hours post-operatively|Patient Satisfaction with Analgesic Technique and Pain management, A Patient Diary will be completed to assess overall satisfaction with analgesic technique, 24 hours post-operatively
Ridge Preservation With FDBA (Freeze Dried Bone Allograft) Using Dexamethasone vs. Saline
NCT Number: NCT06556095
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: EARLY_PHASE1
Conditions: Bone Graft|Tooth Extraction
Interventions: DRUG: Dexamethasone 4mg/ml solution
Sponsor: The University of Texas Health Science Center at San Antonio
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 44
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2027-05
Locations: UT Health Science Center at San Antonio, School of Dentistry, San Antonio, Texas, 78229, United States

Summary:
Following the removal of a tooth, a bone graft is often placed in the socket to try to maintain the volume of bone that was there when the tooth was present so that the bone does not "shrink". The bone graft is kept in place with a small piece of material over the top of the tooth socket and with stitches. This procedure is called "Ridge Preservation". Many different materials are used for ridge preservation, including bone allografts (bone grafts derived from a human tissue donor). These bone allografts are dehydrated (dried) during processing. Before using the material in the socket, the material is re-hydrated (wetted). The most common hydrating (wetting) agent is normal saline (sterile salt water), but other hydrating agents such as blood can also be used. The bone allograft used in this study is Food and Drug Administration (FDA) approved.

Primary Outcome Measures: Percentage of Bone Formation, Difference in percentage of new bone formation at 16 weeks (±2 weeks) after ridge preservation is performed using a combination freeze-dried bone allograft (70% mineralized FDBA:30% demineralized FDBA) that is hydrated for 5 minutes in either sterile saline (control group) or a 4mg/ml dexamethasone solution (test group)., Baseline to 16 weeks (±2 weeks)
Secondary Outcome Measures: Ridge Width, Measurement of change in ridge width after healing, Baseline to 16 weeks (±2 weeks)|Buccal Ridge Height, Measurement of change in ridge height after healing, Baseline to 16 weeks (±2 weeks)|Lingual Ridge Height, Measurement of change in lingual ridge height after healing, Baseline to 16 weeks (±2 weeks)
Clinical Trial of Peer Support in the ED (PCORI)
NCT Number: NCT06556069
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Psychomotor Agitation|Behavioral Disorder
Interventions: OTHER: Peer-Support Enhanced Agitation Code Team (PACT)
Sponsor: Yale University
Collaborators: Patient-Centered Outcomes Research Institute
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 57870
Study Design: Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2025-12-01
Completion Date: 2029-05-01
Locations: Yale New Haven Hospital Health System, New Haven, Connecticut, 06510, United States

Summary:
The purpose of this study is to conduct a clinical trial that tests the acceptability, fidelity, and feasibility of a peer support modified intervention for agitation management within the emergency department.

Primary Outcome Measures: Rate of Restraint Use, Our primary outcome will be rates of Restraint Use, which will be the percent of patients with a behavioral health chief complaint or at risk for agitation who receive either a physical restraint or chemical restraint (defined as intramuscular administration of a sedative) order during an ED visit, measured as a rate per 1,000 ED visits., Up to 1 day
Secondary Outcome Measures: Agitation Symptom Level, Levels and symptoms of agitation during an ED visit will be measured by the Brøset Violence Checklist (BVC), a validated risk assessment tool used to predict violent behavior within a 24-hour period based on presence or absence of patient behaviors and characteristics.

Minimum score = 0 and maximum score = 6. Interpretation as follows: 0 score indicates a small/low risk of violence, a score of 1-2 indicates moderate risk of violence, and a score greater than 2 indicates high risk of violence and a need to develop a plan to manage patient's violence., Up to 1 day
Investigating the Effects of Transcranial Direct Current Stimulation to Different Brain Regions on Ankle Tracking Motor Learning, Motor Adaptation, and Brain Connectivity in Healthy Middle-aged and Older Adults and Patients With Subcortical Stroke
NCT Number: NCT06556043
Acronym: tDCS
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Transcranial Direct Current Stimulation|Ankle|Motor Learning|Adaptation|Brain Structure|Brain Connectivity|Stroke
Interventions: OTHER: cM1 transcranial direct current stimulation|OTHER: cPPC transcranial direct current stimulation|OTHER: iCBM transcranial direct current stimulation|OTHER: sham transcranial direct current stimulation
Sponsor: National Taiwan University Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 120
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: OTHER
Start Date: 2024-07-09
Completion Date: 2026-07-31
Locations: School and Graduate Institute of Physical Therapy, National Taiwan University, Taipei, 100, Taiwan

Summary:
Ankle control is essential to safe over-ground navigation for humans. Middle- aged and older adults and patients with stroke whose ankle control is poor often lose their balance or fall. Transcranial direct current stimulation (tDCS) is an emerging non-invasive brain stimulation technology that has great potential to be applied to neurorehabilitation; however, the optimization of its applications still needs further studies. The aims of this project are to compare the effects of anodal tDCS (AtDCS) applied to the primary motor cortex (M1) contralateral to the moving leg (cM1), posterior parietal cortex (PPC) contralateral to the moving leg (cPPC), and cerebellar cortex (CBM) ipsilateral to the moving leg (iCBM) on motor learning, motor adaptation, and brain connectivity in healthy middle-aged and older adults and hemiparetic patients with chronic subcortical stroke.

Primary Outcome Measures: Change of mean RMSE value of ankle tracking performances, Using a custom-built ankle tracking system, 1 week|Change of Brain MRI data acquisition, Structural images: T1- and T2 weighted imaging, fluid attenuation inversion recovery (FLAIR) images, and diffusion spectrum image (DSI) Functional image: Resting-state functional MRI (rs-fMRI) images using a T2\* gradient echo, echo-planar sequence., 1 week
Secondary Outcome Measures: Fall histories, Fall Efficacy Scale (16\~64 points, the higher score, the worsen outcome), 1 week|Attention, language-free Color Trail Test- Part 1, 1 week|Muscle strength of bilateral ankle dorsiflexors and plantarflexors, Measured with a hand-held dynamometer, 1 week|Mobility, "Timed "Up and Go" test, four square step test, 1 week|Single-task gait, Measured with the GAITRite, 1 week|Sensory and motor functions of patients with stroke, Fugl-Meyer Assessment, 1 week|Balance, One-leg stance, 1 week
A Multicentre, Randomised, Single-blind, Controlled Protocol to Evaluate the Efficacy of Early Administration of Botulinum Toxin for Primary Midline Closure in Patients With Open Abdomen.
NCT Number: NCT06556030
Acronym: BOTU-CLOSURE
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Botulinum Toxin Type A|Open Abdomen|Abdominal Wall|Clinical Trial
Interventions: DRUG: Botulinum Toxin A|OTHER: CONTROL
Sponsor: Instituto de Investigación Hospital Universitario La Paz
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2025-01
Completion Date: 2026-12

Summary:
A multicentre, randomised, single-blind, controlled protocol to evaluate the efficacy of early administration of botulinum toxin for primary midline closure in patients with open abdomen. Early use (less than 48 hours) of botulinum toxin as a neuromuscular abdominal wall blocker in patients whose abdomen is left open, regardless of the cause, will improve postoperative outcome and prognosis, leading to significantly higher percentages of primary midline closure.

Primary Outcome Measures: Main Endpoint, Percentage of patients achieving primary midline closure in the experimental group compared to the control group (within 20 days after the first procedure where the abdomen is left open)., 30 days
Assessment of the Efficacy of ChatGPT in Detecting Surgical Site Infections Following Elective Colorectal Surgery
NCT Number: NCT06556017
Acronym: ChatCCR
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Surgical Site Infection
Interventions: DIAGNOSTIC_TEST: Diagnosis of SSI
Sponsor: Hospital de Granollers
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-15
Completion Date: 2024-10-30

Summary:
Epidemiological surveillance is one of the eight core components of the World Health Organization Infection Prevention and Control Programmes. These include surveillance programmes for surgical site infection (SSI).

At present, for SSI surveillance, infection control teams perform a manual time-consuming work, which could make a transition to automated surveillance leveraging the new information technology.

This study aimed to evaluate the ability of ChatGPT-4o to detect surgical site infection at the three anatomical levels.

Primary Outcome Measures: Rate of surgical site infection, Rate of Surgical site infection according to the definitions of the CDC-NHSN (Centers for Disease Control and Prevention-National Healthcare Safety Network), 30 days
STXBP1 and SYNGAP1 Related Disorders Natural History Study
NCT Number: NCT06555965
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Genetic Disease|STXBP1 Encephalopathy With Epilepsy|SYNGAP1-Related Intellectual Disability
Interventions: OTHER: Non-interventional study
Sponsor: Children's Hospital of Philadelphia
Collaborators: STXBP1 Foundation
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 400
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-08-30
Completion Date: 2028-12-30
Locations: Stanford Medicine Children's Health, Palo Alto, California, 94304, United States|Children's Hospital Colorado, Aurora, Colorado, 80011, United States|Weill Cornell Medicine, New York, New York, 10065, United States|The Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, 19403, United States|Texas Children's Hospital, Houston, Texas, 77030, United States

Summary:
The purpose of this study is to find out more about STXBP1 and SYNGAP1 related disorders. The information gathered by this study will be used to prepare for clinical treatment trials. The primary objective of the study is to better define and outline the clinical spectrum of STXBP1 and SYNGAP1 through detailed developmental, seizure, and quality of life assessments as an extension of routine clinical care.

Primary Outcome Measures: Changes in percentiles recorded on clinical assessments over time, The primary analysis will include all subjects meeting all inclusion and exclusion criteria and completing Visit 1. For each subject, the percentage of items performed correctly on the clinical assessments will be recorded. Changes in percentiles over time will be analyzed using a linear mixed effects model, to account for repeated measures for each patient., Every 6 months upto 5 years
MegaNatural BP® GSE on Blood Pressure and Cardiometabolic Risk Factors
NCT Number: NCT06555952
Acronym: GSEBP
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Hypertension|Pre Diabetes
Interventions: DRUG: MegaNatural-BP SR 150Mg Tablet|OTHER: Placebo Capsule
Sponsor: Clinical Nutrition Research Center, Illinois Institute of Technology
Sex: ALL
Age: ADULT
Enrollment: 80
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: PREVENTION
Start Date: 2024-08-08
Completion Date: 2025-05-22
Locations: Clinical Nutrition Research Center, Chicago, Illinois, 60616, United States

Summary:
Inflammation and stressors can interfere with the function of the lining of blood vessels and insulin activity, therefore, investigators are aiming to see how the Grape seed Extract (GSE) called MegaNatural BP can help with limiting the effects of these factors. This research will study the effects of taking 150mg of MegaNatural BP GSE per day on blood pressure levels along with influences on heart health through assessing the function of the blood vessel lining and levels of inflammation.

Primary Outcome Measures: Difference in change of systolic blood pressure, After 6 weeks of 150mg GSE MegaNatural BP per day the base level blood pressure should change, 6 weeks|Difference in change of diastolic blood pressure, After 6 weeks of 150mg GSE MegaNatural BP per day the base level blood pressure should change, 6 weeks
Secondary Outcome Measures: Change in vessel flexibility, Change in vessel flexibility as measured by flow mediated vasodilation acutely and chronically after GSE MegaNatural BP, 6 weeks|Change in fasting and postprandial glucose, Change in fasting and postprandial glucose as measured by absolute values and calculated insulin sensitivity using homeostasis model assessment of fasting insulin senisitivity (HOMA-%S) and B-cell function (HOMA-%) and assessment of peripheral insulin sensitivity using Matsuda index., 6 weeks|Change in fasting and postprandial insulin, Change in fasting and postprandial insulin as measured by absolute values and calculated insulin sensitivity using homeostasis model assessment of fasting insulin senisitivity (HOMA-%S) and B-cell function (HOMA-%) and assessment of peripheral insulin sensitivity using Matsuda index., 6 weeks|Change in inflammatory marker C-reactive protein, additional plasma collected and saved for future analysis as study results warrant, 6 weeks|Change in the ratio of arginine:ADMA, will be analyzed using High Performance Liquid Chromatography with mass analysis capabilities of mass spectrometry (MS), 6 weeks|Change in GSE metabolites profiles, will be analyzed using High Performance Liquid Chromatography with mass analysis capabilities of mass spectrometry (MS), 6 weeks
Promoting Resilience Among Adolescents and Young Adults With Sickle Cell Disease
NCT Number: NCT06555939
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Sickle Cell Disease
Interventions: BEHAVIORAL: Collaborative Care Model|BEHAVIORAL: Promoting Resilience in Stress Management
Sponsor: Boston Children's Hospital
Collaborators: National Institutes of Health (NIH)
Sex: ALL
Age: CHILD, ADULT
Enrollment: 25
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-10
Completion Date: 2030-09

Summary:
Adolescents and young adults with sickle cell disease (SCD) face challenges managing their illness and maintaining their well-being. This study proposes to test the feasibility and acceptability of a resilience-promoting intervention through a Collaborative Care Model. The primary goal is to determine with the resilience intervention (PRISM) is feasible and acceptable for adolescents and young adults with SCD. Exploratory outcomes include whether this intervention improves depression, anxiety, and pain interference.

Primary Outcome Measures: Enrollment rate (feasibility), feasibility assessed by \>50% enrollment rate, 3-months
Secondary Outcome Measures: Acceptability, program usefulness and willingness to recommend it (assessed via qualitative interviews), 3-months post-enrollment
Other Outcome Measures: Patient-Health Questionnaire (PHQ-9), depressive symptoms, range 0-27 with higher scores indicating higher symptoms, 3-months|Generalized Anxiety Disorder (GAD-7), anxiety symptoms, range 0-21 with higher scores indicating higher symptoms, 3-months
Effect of Acupressure on Carpal Tunnel Syndrome in Pregnant Women
NCT Number: NCT06555926
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Carpal Tunnel Syndrome
Interventions: OTHER: Acupressure|OTHER: advices for relieving carpal tunnel syndrome
Sponsor: Cairo University
Sex: FEMALE
Age: ADULT
Enrollment: 50
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2024-12

Summary:
This study will be conducted to investigate the effect of acupressure on carpal tunnel syndrome in pregnant women.

Primary Outcome Measures: Assessment of pain severity, The pain intensity will be assessed for all participants in both groups before and after treatment through VAS. It is a 10 cm horizontal line on which the participant's pain intensity will be represented by a point between the extremes of "no pain at all" and "worst imaginable pain". Each participant will be asked to mark a point on a VAS line between the extremes that related to her current pain intensity, 12 weeks|median nerve conduction study, Computerized Electromyography (Dantce): ATOENINIES neuro screen system will be used to perform median nerve conduction study before and after the treatment program for all participants in both groups, 12 weeks
Maitland Mobilization and Scapular Stabilization Shoulder Dysfunction
NCT Number: NCT06555913
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Head and Neck Cancer
Interventions: OTHER: Maitland Mobilization|OTHER: Scapular Stabilization|OTHER: Traditional Physical Therapy
Sponsor: Cairo University
Sex: ALL
Age: ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2023-11-01
Completion Date: 2024-07-01
Locations: Faculty of Physical Therapy, Giza, 12613, Egypt

Summary:
Sixty patients from both genders suffering from shoulder disability post unilateral NDS (modified radical, selective) will participate in this study. Their ages will be ranged from 30 to 50 years. They will be selected randomly from Damanhur Oncology center, El-Behira, Egypt. They will be randomly distributed into three equal groups (each group 20 patients).

Primary Outcome Measures: Digital Goniometer, Digital goniometer is a device which measures joint ranges, together with velocity and acceleration variables, with a high level of precision and at a relatively low-cost, practically similar to current analogical tools. The digital goniometer is a device specifically designed for the measurement of angles of movement of the human body with a resolution of 1°, representing an ideal substitute to traditional goniometers, which are usually based on a scale of 5° increments, 2 months
Secondary Outcome Measures: Shoulder Pain and Disability Index, The shoulder pain and disability index (SPADI) is a self-report questionnaire developed to measure the pain and disability associated with shoulder pathology. The SPADI consists of 13 items in two subscales: pain (5 items) and disability (8 items), the original version has each item scored on a visual analogue scale (VAS) and a second version has items scored on a numerical rating scale (NRS), 2 months
Predicting Episodes of Intracranial Hypertension in Neuro-injured Patients: Development of a Decision Algorithm Using Artificial Intelligence (PREDICT-CE)
NCT Number: NCT06555900
Acronym: PREDICT-CE
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Creation of a Warehouse of Clinical Data and Physiological Signals at the Patient's Bedside
Sponsor: University Hospital, Brest
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 500
Study Design: Observational Model: |Time Perspective: p
Start Date: 2020-12-17
Completion Date: 2025-06-30
Locations: CHU de Brest, Brest, 29609, France

Summary:
The investigators wish to build up a database of clinical data and physiological signals with a view to developing a predictive algorithm based on continuous analysis of the intracranial pressure waveform and other parameters commonly used in intensive care to predict the occurrence of an episode of intracranial hypertension (HTIC). This algorithm will be designed using supervised learning statistical methods based on innovative statistical analysis methods (artificial intelligence). These methods are classically used to exploit massive data such as sensor data.

Primary Outcome Measures: Creation of a database of clinical data and physiological signals to develop a predictive algorithm based on continuous analysis of the intracranial pressure waveform to predict the occurrence of an episode of intracranial hypertension., Occurrence of an episode of intracranial hypertension defined as ICP \>20mmHg for 30 minutes, 30 minutes
Secondary Outcome Measures: Predict long-term functional outcome using intracranial pressure wave signal modeling and other parameters collected in real time, Occurrence of vasospasm diagnosed by cerebral perfusion angioscanner, 28 days
Anterior Discectomy Surgery With Arthrodesis in Degenerative Spinal Canal sténoses. (ICASC)
NCT Number: NCT06555887
Acronym: ICASC
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Lumbar Canal Stenosis
Sponsor: University Hospital, Brest
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 14
Study Design: Observational Model: |Time Perspective: p
Start Date: 2020-07-01
Completion Date: 2020-10-31
Locations: CHRU de Brest, Brest, 29609, France

Summary:
Single-center retrospective study to characterize changes in the functional capacity of patients (change in Oswestry Desability Index (ODI)) undergoing anterior approach surgery for the management of symptomatic lumbar spinal stenosis between the pre-surgical period and the first assessment 6 months after surgery.

Primary Outcome Measures: characterize the evolution of functional capacity in patients undergoing anterior approach surgery for the management of symptomatic lumbar spinal stenosis, Variation in Oswestry Desability Index (ODI) between pre-surgery and first assessment beyond 6 months post-surgery, 6 month
Evaluation of the MORENO Score for the Regulation
NCT Number: NCT06555874
Acronym: ESMORTSAB19
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: the Safety / Feasibility /MORENO Score/Regulation / Secondary Transfers / SAMU 29 / Current Practices
Sponsor: University Hospital, Brest
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1500
Study Design: Observational Model: |Time Perspective: p
Start Date: 2020-06-01
Completion Date: 2021-06-30
Locations: Chu Brest, Brest, 29609, France

Summary:
The main objective of this work is therefore to evaluate the safety and feasibility of the MORENO score for the regulation of secondary transfers to the SAMU 29 compared to current practices.

Primary Outcome Measures: Evaluation of the concordance of the MORENO score for the regulation of secondary transfers at SAMU 29 and our current practices, Rate of agreement between our practices and the MORENO score strategy., 1 year
Local Recurrence Prediction of by Texture Analysis Derived From Positron Emission Tomography (PET / CT) Imaging of Non-small Cell Lung Cancer (NSCLC) Treated With Stereotactic Radiotherapy (SBRT) (Retros MUMOFRAT)
NCT Number: NCT06555861
Acronym: MUMOFRAT retro
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Identify FDG PET/CT Parameters Predictive of Local Control
Sponsor: University Hospital, Brest
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 87
Study Design: Observational Model: |Time Perspective: p
Start Date: 2019-01-07
Completion Date: 2019-02-06
Locations: ICO, Nantes, Saint Herblain, 44800, France|CHRU de Brest, Brest, 29609, France|Centre Eugènes Marquis, Rennes, 35042, France|CHU de Tours, Tours, 37000, France

Summary:
The aim of this retrospective multicentric study was to develop and evaluate a prognostic FDG PET/CT radiomics signature in early-stage non-small cell lung cancer (NSCLC) patients treated with stereotactic radiotherapy (SBRT).

Primary Outcome Measures: Local Recurrence, accuracy, Time-to-Event measures up to 5 years
Secondary Outcome Measures: Cancer specific survival, accuracy, Time-to-Event measures up to 5 years|Distant metastasis free survival, accuracy, Time-to-Event measures up to 5 years|Recurrence free survival, accuracy, Time-to-Event measures up to 5 years|Overall survival, accuracy, Time-to-Event measures up to 5 years