pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Effect of Neoadjuvant Chemotherapy on Cardiac Function of Perioperative Patients With Breast Cancer and New Strategies for Anesthesia
NCT Number: NCT06497660
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Breast Cancer|Neoadjuvant Chemotherapy|Perioperative Period|Anaesthesia|Cardiac Function
Interventions: DRUG: Deoxyadrenaline|DRUG: normal saline
Sponsor: Fujian Medical University Union Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 496
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, CARE_PROVIDER)|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2025-12-31

Summary:
As is well known, perioperative hemodynamic fluctuations, such as decreased blood pressure and heart rate, and cardiac dysfunction, are common complications after anesthesia. General anesthetics such as propofol and sufentanil can inhibit the central nervous system, reduce cardiac excitability and myocardial contractility, dilate peripheral blood vessels, and have a high incidence of hypotension, especially during anesthesia induction, which is particularly common in the elderly and those with underlying underlying diseases before surgery.

However, the current research on the impact of neoadjuvant chemotherapy on perioperative cardiac function in patients is not specific, and there is no unified anesthesia strategy for these effects during the perioperative period. Therefore, this study aims to explore: 1. the effect of neoadjuvant chemotherapy on perioperative cardiac function in patients; 2. Improve the anesthesia plan and further explore new strategies for perioperative organ protection for such patients. The research design is a prospective, randomized, controlled trial.

Primary Outcome Measures: The degree of blood pressure decrease during anesthesia induction, Compare the blood pressure changes of patients after entering the operating room and undergoing anesthesia induced tracheal intubation.（Unit in mmHg）, On the day of surgery, compare the blood pressure changes of patients after entering the operating room and anesthesia induced tracheal intubation, with a maximum of 12 months after surgery.
New Treatment for Nocturnal Enuresis in Children
NCT Number: NCT06497647
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Nocturnal Enuresis in Children
Interventions: DRUG: Sulbutiamine|DRUG: Imipramine
Sponsor: Sohag University
Sex: ALL
Age: CHILD, ADULT
Enrollment: 450
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-03-01
Completion Date: 2024-11
Locations: Sohag Faculty of Medecine, Sohag, Egypt

Summary:
The aim of the study is to evaluate the role of sulbutiamine in treatment of monosymptomatic nocturnal enuresis in children by using it alone or as a combination therapy with tricyclic antidepressants (imipramine+sulbutiamine).

Primary Outcome Measures: reduction in the number of wet nights ., A questionnaire which measure the Response to treatment which will be evaluated by the standardization committee of International clildren's continence society (ICCS) as follows :

* Complete response : 100% reduction
* Partial response : 50% - 99% reduction
* Unresponsiveness : 0 - 49% reduction in nocturnal enuresis episodes.

this will be measured by a questionnaire that will be written according a calendar fulfilled by the child and his parents with comparison of the number of wet nights each month., the number of wet nights will be measured and compared at the end of each month for 3 months using a calendar fulfilled by the child and his parents.
Secondary Outcome Measures: determine any side effects of the drugs used in the study, asking the child and his parents about any abnormal findings or symptoms appear in the period of the treatment this will be done by a questionnaire that will be fulfilled by the child and his parents., this will be discussed in the follow up that will be done in each month in the outpatient clinic for 3 months.
Effect of Spinal Needle Type on Optic Nerve Sheath Diameter
NCT Number: NCT06497634
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Spinal Anesthesia|Intracranial Pressure Change|Optic Nerve Sheath Diameter|Orthopedic Surgery|Cerebrospinal Fluid Leak
Interventions: PROCEDURE: 25 PP|PROCEDURE: 25 Q|PROCEDURE: 27 Q|OTHER: Optic Nerve Sheath Measurement
Sponsor: Bagcilar Training and Research Hospital
Sex: ALL
Age: ADULT
Enrollment: 165
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-08-15
Completion Date: 2024-12-30
Locations: Bagcılar Training Research Hospital, Istanbul, Bagci̇lar, Turkey

Summary:
The optic nerve sheath is a continuation of the dura mater, extending along the subarachnoid space surrounding the optic nerve. Consequently, changes in intracranial pressure cause an augmentation or contraction in the diameter of the optic nerve sheath, which is coreleted with intracranial pressure. Participants undergoing lower extremity operations (ankle, distal tibia and fibula surgeries) using a tourniquet under spinal anesthesia will be investigated. Spinal anesthesia will be performed with a 25 G Whitacre, 25 G Quincke, or 27 G Quincke needle, depending on the study group. Optic nerve sheath diameter (ONSD) measurements will be performed before spinal anesthesia; and 5 minutes, 15 minutes,,24 hours after spinal block, respectively.The 4th measurement will be performed after tourniquet is opened. Measurements will be done with 15 MHz linear ultrasound (US) probe in B mode, 3 mm behind the posterior globe in the transverse plane from both eyes, on upper eyelid. Values will be recorded numerically. The impact of spinal anesthesia administered using various needle designs (Quincke and Whitacre) and sizes (25G-27G) on intracranial pressure will be investigated.

Primary Outcome Measures: Optic nerve sheath diameter, The primary aim is to compare optic nerve sheath diameter (ONSD) according to the spinal needle type and size, ONSD changes from baseline, at 5 minutes, 15 minutes, 24 hours after spinal anesthesia and opening the tourniquet
Secondary Outcome Measures: Blood pressure, The effect of needle type and size on blood pressure, Changes from baseline, at 5 minutes, 15 minutes, 24 hours after spinal anesthesia and opening the tourniquet|Hearth rate, The effect of needle type and size on hearth rate, Changes from baseline, at 5 minutes, 15 minutes, 24 hours after spinal anesthesia and opening the tourniquet|Oxygen saturation, The effect of needle type and size on oxygen saturation, Changes from baseline, at 5 minutes, 15 minutes, 24 hours after spinal anesthesia and opening the tourniquet
Other Outcome Measures: Nause and vomiting, Number of participants with nause and vomiting in first 24 hours, First 24 hours|Double vision, Number of participants with double vision in first 24 hours, First 24 hours|Headache, Number of participants with headache in first 24 hours, First 24 hours
Comparing Impression Techniques for Maxillary Complete Denture Retention
NCT Number: NCT06497621
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Denture Retention|Patient Satisfaction
Interventions: PROCEDURE: Single step PVS impression|PROCEDURE: Conventional two-step PVS impression
Sponsor: Aga Khan University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 35
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, OUTCOMES_ASSESSOR)|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2025-07-01
Completion Date: 2027-03-31

Summary:
The primary objective of this protocol is to compare retention in maxillary complete dentures using single-versus two-step Poly-vinyl Siloxane (PVS) impressions in edentulous patients at denture delivery. Secondary objectives include assessing patient satisfaction with impression methods and denture satisfaction after a two-month adaptation and comparing post-delivery adjustment visits.

Primary Outcome Measures: Retention of maxillary denture using digital force meter, Three readings will be taken for each maxillary denture using digital force meter, and an average will be calculated in units for Newton (N) or Kg.m/s2., At the delivery appointment for each denture at an average of 2.5 week from the start of denture fabrication and at 8th week (+/- 3 days)
Secondary Outcome Measures: Patient satisfaction with impression methods via the Burdens in Dental Impression-Making Questionnaire (BiDIM-Q), The questionnaire consists of 12 questions covering various aspects of the impression-making process. Prosthodontists will request patients to score each question from 1 to 100 to gauge their response. A higher score for an aspect of the impression-making procedure will indicate a higher degree of satisfaction., At the delivery appointment for each denture at an average of 2.5 week from the start of denture fabrication and at 8th week (+/- 3 days)|Denture satisfaction using the Denture Satisfaction (DS) questionnaire., The questionnaire comprises 11 questions, answered on a 4-point Likert-type scale to assess the patient's experience with the dentures provided., At 2 months
Other Outcome Measures: Number of post-insertion visits for denture adjustment, The research team will record the post-delivery visits required to adjust dentures fabricated from two different impression methods in the study Pro-forma., At the end of adjustment period of each denture at an average of 1-month after denture delivery
Single-Cell Insights Into Diabetic Retinopathy Mechanisms
NCT Number: NCT06497608
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Diabetic Retinopathy
Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 66
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07
Completion Date: 2027-07

Summary:
This study aims to uncover the cellular and molecular mechanisms of diabetic retinopathy through single-cell sequencing to identify new therapeutic targets.

The study will collect retinal tissue samples from 3 patients with advanced proliferative diabetic retinopathy who underwent prosthetic eye implantation and 3 normal cadaver donors. Additionally, aqueous humor, vitreous fluid, and plasma samples from patients with severe diabetic retinopathy requiring surgery and macular hole surgery patients without diabetic retinopathy will be analyzed using ELISA, qPCR, and Western Blot. These experiments will validate sequencing results and explore the pathogenesis of diabetic retinopathy to identify potential treatment targets.

Primary Outcome Measures: Single cell sequencing result, Single cell RNA and ATAC sequencing of human retinas, 1 month
Secondary Outcome Measures: Validation experiment result, Experiments such as ELISA and immunofluorescence staining to validate the result from single cell sequencing, 1 month
Intrathecal Pemetrexed for SCLC Patients With Refractory Brain Metastases or Leptomeninges Metastatic
NCT Number: NCT06497543
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Small-cell Lung Cancer
Interventions: DRUG: Intrathecal Pemetrexed
Sponsor: Hunan Province Tumor Hospital
Collaborators: Second People's Hospital of Hunan
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2026-04-30
Locations: Yongchang Zhang, Changsha, Hunan, 410013, China

Summary:
This study aimed to evaluate the efficacy and safety of intrathecal pemetrexed for SCLC patients with refractory brain metastases or leptomeningeal metastasis.

Primary Outcome Measures: Overall Survival, OS was defined as the duration from the start of intrathecal pemetrexed to patient death, Time from first subject dose to study completion, or up to last follow up
Secondary Outcome Measures: Intracranial progression-free survival (I-PFS), Intracranial progression-free survival was defined as the duration from the start of intrathecal pemetrexed to the worsening of neurological symptoms, radiological confirmation of brain progression, or patient death, Time from first subject dose to study completion, or up to 36 month|Intracranial Objective Response Rate (I-ORR), To assess Intracranial overall response rate according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by investigator, define as the proportion of subjects who have a complete response (CR) or a partial response (PR), Time from first subject dose to study completion, or up to 36 month|clinical remission rate, Clinical Response Rate was defined as the ratio of the patient whose neurological symptoms and KPS improved according to the criteria of clinical response, Time from first subject dose to study completion, or up to 36 month|Adverse events (AEs), Number of participants with adverse events (AEs) according to CTCAE 5.0, Time from first subject dose to study completion, or up to 36 month
Maintenance Lurbinectedin in Combination With Serplulimab for Patients With ES-SCLC
NCT Number: NCT06497530
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Extensive-Stage Small Cell Lung Cancer
Interventions: DRUG: Serplulimab|DRUG: Lurbinectedin|DRUG: Carboplatin|DRUG: Etoposide
Sponsor: Guangzhou Institute of Respiratory Disease
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
Completion Date: 2025-12

Summary:
This is a single-arm, open-lable exploratory study of Lurbinectedin in combination with Serplulimab as maintenance therapy in participants with extensive-stage small-cell lung cancer (ES-SCLC) after first-line induction therapy with carboplatin, etoposide, and Serplulimab. The study consists of 2 phases: an induction phase and a maintenance phase. Participants need to have an ongoing response or stable disease per the Response Evaluation Criteria in Solid Tumor (RECIST) v1.1 criteria after completion of 4 cycles of carboplatin, etoposide, and Serplulimab induction treatment in order to be considered for eligibility screening for the maintenance phase. Eligible participants will receive lurbinectedin plus Serplulimab in the maintenance phase.

Primary Outcome Measures: Progression-Free Survival (PFS), progression-free survival (PFS) is defined as the time from treatment initiation to the date of first documented disease progression (as assessed according to RECIST v1.1) or death whichever occurs first., Treatment initiation to the date of first documented disease progression or death whichever occurs first (up to approximately 24 months)
Secondary Outcome Measures: Overall Survival (OS), Overall survival (OS) is defined as the time from treatment initiation to the date of death from any cause., Treatment initiation to the date of death from any cause(up to approximately 24 months)|Objective Response Rate (ORR), Objective response rate (ORR) is defined as the proportion of participants with a complete response（CR） or partial response（PR） according to RECIST v1.1., up to approximately 24 months|Duration of Response (DOR), Duration of Response (DOR) (for participants with a confirmed objective response) is defined as the time from the first occurrence of a documented confirmed objective response until disease progression according to RECIST v1.1 or death from any cause, whichever occurs first., up to approximately 24 months|Percentage of Participants With Adverse Events, Percentage of participants with adverse events, up to approximately 24 months
A Study to Investigate the Effect of Food on Camlipixant Concentrations in Healthy Participants
NCT Number: NCT06497517
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Cough
Interventions: DRUG: GSK5464714- Camlipixant
Sponsor: Bellus Health Inc. - a GSK company
Sex: ALL
Age: ADULT
Enrollment: 14
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-09
Completion Date: 2024-08-22
Locations: GSK Investigational Site, Austin, Texas, 78744, United States

Summary:
This study is a single center, single dose, open-label, randomly assigned 2-way crossover study. The study will investigate the food effect on the pharmacokinetics of Camlipixant (GSK5464714) in healthy male and female participants. Eligible participants will be randomized to pre-defined sequences. There will be a washout of minimum 7 days between each dose of treatment period.

Primary Outcome Measures: Area Under the Plasma Concentration-Time Curve (AUC) from Time Zero to Infinity Post-Dose [AUC(0-inf), Up to Day 3 for each period|Maximum Observed Plasma Drug Concentration (Cmax), Up to Day 3 for each period
Secondary Outcome Measures: Time to Maximum Observed Plasma Drug Concentration (Tmax), Up to Day 3 for each period|Apparent Terminal Phase Half-Life (t½), Up to Day 3 for each period|Apparent Oral Clearance (CL/F), Up to Day 3 for each period|AUC from Time Zero to Last Quantifiable Concentration [AUC(0-t), Up to Day 3 for each period|Apparent Volume of Distribution (Vz/F), Up to Day 3 for each period|Number of Participants Reported for Adverse events, Serious Adverse Events and Adverse Events of Special Interest, Up to 3 weeks|Absolute Values for Clinical Laboratory Parameters Over Time, Up to 3 weeks|Absolute Values for 12- Lead Electrocardiogram (ECG) Over Time, Up to 3 weeks|Absolute Values for Vital Sign Measurements Over Time, Up to 3 weeks|Changes from Baseline for Clinical Laboratory Parameters Over Time, Up to 3 weeks|Changes from Baseline for 12- Lead ECG Over Time, Up to 3 weeks|Changes from Baseline for Vital Sign Measurements Over Time, Up to 3 weeks
Study of Bepirovirsen in Participants Living With Human Immunodeficiency Virus and Chronic Hepatitis B Virus Infection (B-Focus)
NCT Number: NCT06497504
Acronym: B-Focus
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Hepatitis B
Interventions: DRUG: Bepirovirsen|DRUG: Placebo
Sponsor: GlaxoSmithKline
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 150
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-19
Completion Date: 2027-05-03
Locations: GSK Investigational Site, Bakersfield, California, 93301, United States|GSK Investigational Site, Orlando, Florida, 32803, United States|GSK Investigational Site, West Palm Beach, Florida, 33401, United States|GSK Investigational Site, Baltimore, Maryland, 21287, United States|GSK Investigational Site, Minneapolis, Minnesota, 55415, United States|GSK Investigational Site, Hillsborough, New Jersey, 08844, United States|GSK Investigational Site, Ottawa, Ontario, K1H 8L6, Canada|GSK Investigational Site, Toronto, Ontario, M5G 1K2, Canada|GSK Investigational Site, Montreal, Quebec, H2L 4P9, Canada|GSK Investigational Site, Montreal, Quebec, H4A 3J1, Canada|GSK Investigational Site, Québec, G1V 4G2, Canada|GSK Investigational Site, Boksburg, Gauteng, 1459, South Africa|GSK Investigational Site, Durban, KwaZulu- Natal, 4052, South Africa|GSK Investigational Site, Observatory, Cape Town, 7925, South Africa|GSK Investigational Site, Westdene, 2092, South Africa

Summary:
This study will evaluate the efficacy and safety of bepirovirsen compared to placebo in participants with Human Immunodeficiency Virus (HIV)/Hepatitis B Virus (HBV) co-infection.

Primary Outcome Measures: Percentage of participants achieving HBV virologic response at 36 weeks after scheduled end of study treatment in absence of rescue medication, HBV virologic response defined as HBV surface antigen (HBsAg) not detected and HBV Deoxyribonucleic acid (DNA) less than (\<) Lower limit of quantification (LLOQ), At study week 60
Secondary Outcome Measures: Percentage of participants achieving HBV virologic response at the scheduled end of study treatment in absence of rescue medication, HBV virologic response defined as HBsAg not detected and HBV DNA \<LLOQ, At study week 24
A Study of Efficacy and Safety of Glofitamab in Combination With Salvage Therapy in a Real-world Setting in Chinese Adult Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma.
NCT Number: NCT06497452
Acronym: GLOFTST
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: B-cell Non-Hodgkin Lymphoma
Interventions: DRUG: Glofitamab
Sponsor: The First Affiliated Hospital of Soochow University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-01
Completion Date: 2026-06-01
Locations: The First Affiliated Hospital of Soochow University, Suzhou, Jiangsu, 215000, China

Summary:
The purpose of this study is to assess the efficacy and safety in the real-world settings of glofitamab in combination with salvage therapy among Chinese adult patients with relapsed or refractory B-cell non-hodgkin lymphoma.

Primary Outcome Measures: Best Complete Response Rate (bCRR) Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma, Baseline up to EOT (approximately 9 months)
Secondary Outcome Measures: Best Overall Response Rate (bORR) Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma, Baseline up to EOT (approximately 9 months)|Duration of Response (DoR), From the date of the first occurrence of a documented CR or partial response (PR) to the date of progression, relapse, or death from any cause, whichever occurs first (up to approximately 24 months)|Duration of Complete Response (DoCR), From the date of the first occurrence of a documented CR to the date of progression, relapse, or death from any cause, whichever occurs first (up to approximately 24 months)|PFS Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma, Baseline up to end of study (approximately 24 months)|Event Free Survival (EFS) Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma, From the start of glofitamab treatment to any treatment failure including disease progression, relapse, initiation of new antilymphoma therapy (NALT), or death from any cause, which occurs first (up to approximately 24 months)|Overall Survival (OS), From the start of glofitamab treatment until the date of death from any cause (up to approximately 24 months)|Time to Next Treatment (TTNT), From the start of glofitamab treatment to the initiation of next-line treatment (up to approximately 24 months)
Efficacy and Safety of Silfamin for Common Cold
NCT Number: NCT06497439
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Common Cold|Sore-throat
Interventions: DRUG: Silfamin|DRUG: Placebo tablet of Silfamin
Sponsor: Dexa Medica Group
Collaborators: Fakultas Kedokteran Universitas Indonesia
Sex: ALL
Age: ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2025-02
Locations: IMERI Faculty of Medicine, University of Indonesia, Jakarta Pusat, Jakarta, 10430, Indonesia|Makara UI Satellite Clinic, Depok, Jawa Barat, 16425, Indonesia

Summary:
This is a 2-arm, prospective, randomized, double-blind, placebo-controlled, and three-days-treatment clinical study comparing the efficacy and safety of Silfamin at a dose of 2 tablets@150 mg twice daily in subjects with common cold.

Primary Outcome Measures: Score of common cold and sore throat, Score of common cold and sore throat measured at 0 hours (just before drug administration) for the first dose, 1 and 2 hours after every dosing, 30 minutes, 60 minutes, 90 minutes, 2 hours, 1 day, 2 days, 3 days|VAS score of sore throat, VAS score of sore throat measured at 0 hours (just before drug administration), 1 and 2 hours after every dosing, 30 minutes, 60 minutes, 90 minutes, 2 hours, 1 day, 2 days, 3 days
Secondary Outcome Measures: Adverse events, Number of adverse event, will be observed throughout the study conduct, 1, 2, 3 days
Brain Vascular and Neurocognitive Health
NCT Number: NCT06497413
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cognitive Decline|Cognitive Dysfunction|Alzheimer Disease|Vascular Disease, Peripheral
Interventions: DEVICE: Transcranial Photobiomodulation|DEVICE: Transcranial Photobiomodulation helmet (Neuradiant 1070 Plus) with no light administered
Sponsor: The University of Texas at Arlington
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: SINGLE (INVESTIGATOR)|Primary Purpose: PREVENTION
Start Date: 2024-04-16
Completion Date: 2025-12-31
Locations: UT Arlington - Science and Engineering Innovation and Research Building, Arlington, Texas, 76010, United States

Summary:
The overall research objective of this proposal is to determine the acute and chronic impact of transcranial photobiomodulation on indices of cerebral vascular health and neurocognitive function.

Primary Outcome Measures: Cerebral vasodilator function, This will be assessed as the increase in blood flow in the middle cerebral artery during a hypercapnic stimulus, Immediately before the start of the experimental or sham condition intervention. And immediately after the end of the experimental or sham condition intervention.|Neurocognitive function, This will be assessed using the NIH Toolbox which is a battery that consists of several cognitive challenges., Immediately before the start of the experimental or sham condition intervention. And immediately after the end of the experimental or sham condition intervention.
Application of an Exercise Program Versus Exercise Plus Manual Therapy in the Treatment of Adhesive Capsulitis.
NCT Number: NCT06497348
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Capsulitis of Shoulder|Frozen Shoulder
Interventions: OTHER: manual therapy and exercises (experimental group) or only exercises (control group) in people with frozen shoulder
Sponsor: University of Alcala
Sex: ALL
Age: ADULT
Enrollment: 108
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-15
Completion Date: 2024-12-15
Locations: Facultad de Enfermeria y Fisioterapia de la Universidad de Alcalá de Henares, Madrid, 28801, Spain

Summary:
The main objective is to evaluate whether a treatment program combining manual therapy (joint mobilization) and exercise is more effective in the treatment of adhesive capsulitis than an exercise program applied in isolation.

The researchers will compare both groups (experimental group and control group) using the different techniques.

During the sessions, mobility will be evaluated with a goniometer and data will be recorded to monitor progress, maintaining a confidential record of the data.

Primary Outcome Measures: evaluation of the improvement of shoulder mobility in patients with adhesive capsulitis by performing by an exercise program, mobilization or boths techniques., study and measure if there is improvement in adhesive capsulitis of the shoulder with the proposed exercise programs versus exercise plus manual therapy in 108 subjects, 54 subjects in each group and a descriptive analysis of the data will be carried out, examining the initial homogeneity between the groups. in terms of the variables age, sex, pain, range of motion and functionality. The Shoulder Pain and Disability Index (SPADI) questionnaire and the visual analogue scale (VAS) will be used to assess pain., 3-4 months
Accuracy of Non Invasive Hemoglobin Measure by SpHb Device in Post Operative Anemia Diagnosis
NCT Number: NCT06497335
Acronym: SpHb_gyneco
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Anemia
Interventions: DIAGNOSTIC_TEST: non invasive hemoglobin measure
Sponsor: University Hospital, Angers
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 150
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-30
Completion Date: 2026-01

Summary:
Non invasive Hemoglobin monitoring by SpHb device had been developed to assess Hemoglobin level during hemorrhagic surgery. It's accuracy to detect post operative anemia on a single post operative measure has been recently demonstrated on a cohort of post operative orthopedic patient and it's routine use has been generalized to other surgical department. This study aims to valid these finding on a cohort of post operative patients from gynaecological department.

Primary Outcome Measures: accuracy between SpHb measure and Hemoglobin level on the post operative blood sample, level of immediate post operative SpHb measure compared to blood hemoglobin measure, ROC curve, at 2 and 8 months after establishment of PBM protocol
Secondary Outcome Measures: Spearman correlation coefficient, correlation between Laboratory Hb and SpHb measure, at 2 and 8 months after establishment of PBM protocol|Kappa coefficient, correlation between SpHb measure and correct classification of patients anemia vs no anemia, at 2 and 8 months after establishment of PBM protocol|Intra class correlation coefficient, correlation between Laboratory measurement and SpHb measurement, at 2 and 8 months after establishment of PBM protocol|Subgroup analysis of ROC curve (classes of age 18-30; 30-40; 40-50; >50), comparison of ROC curve areas in subgroups, at 2 and 8 months after establishment of PBM protocol|impact of body temperature on accuracy of SpHb, comparison of ROC curve areas in subgroups of temperature (classes of temperature : \<35; 35-36; \>36), at 2 and 8 months after establishment of PBM protocol|impact of perfusion index on accuracy of SpHb, comparison of ROC curve areas in subgroups of perfusion index (good or low perfusion index), at 2 and 8 months after establishment of PBM protocol|impact of leght between SpHb measurement and laboratory Hb measurement on accuracy, comparison of ROC curve areas in subgroups of lenght in days between SpHb measurement and Laboratory Hb measurement, at 2 and 8 months after establishment of PBM protocol
The Optimal Timing of the Initiation of Esophagogastroduodenoscopy After Oral Lidocaine Spray
NCT Number: NCT06497296
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Blood Pressure|Tachycardia
Interventions: DRUG: Lidocaine
Sponsor: National Cheng-Kung University Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 160
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2023-01-01
Completion Date: 2024-12-31
Locations: Hsueh-Chien Chiang, Tainan, Other (Non U.s.), 704, Taiwan

Summary:
Esophagogastroduodenoscopy (EGD) is the main examination in the upper gastrointestinal field. Aspiration pneumonia may happen if choking occurs during the EGD insertion, and the exam quality and efficacy may be affected if gag reflex occurs. The endoscopist may terminate the exam to avoid complications if the patient could not obey the orders. To reach the high quality of EGD examination and to avoid possible complications, the patient's comfort and compliance during the EGD examination are important. Sedation using propofol can improve the patient's comfort and compliance. However, in patients unsuitable for systemic anesthesia, local lidocaine spray at pharynx is performed instead. Until now, there is no standardization of the waiting time between lidocaine spray and the initiation of EGD. This study aimed to investigate the optimal timing of the initiation of esophagogastroduodenoscopy after lidocaine spray.

Primary Outcome Measures: Heart rate change, The increase level of heart rate between baseline and during the pharynx insertion of EGD, 1 day|Blood pressure change, The increase level of systolic blood pressure between baseline and during the pharynx insertion of EGD, 1 day
Secondary Outcome Measures: EGD comfort quality questionnaire score, comfort quality questionnaire will be written by an assistant and the patient after the EGD procedure. The score includes pain feeling (1-5 points), nausea sensation (1-5 points), abdominal fullness (1-5 points). A higher score indicates more discomfort., 1 day
Binaural Sound for Remimazolam Maintenance
NCT Number: NCT06497283
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: General Anesthesia|Prostate Cancer Stage|Uterine Myoma
Interventions: PROCEDURE: Binaural sound
Sponsor: Gangnam Severance Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 72
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-07-12
Completion Date: 2025-02-28
Locations: Gangnam Severance Hospital, Seoul, Korea, Republic of

Summary:
It is important to decrease the remifentanil dose for general anesthesia maintenance when using remimazolam. We will evaluate the effect of binaural sound on general anesthesia maintenance with remimazolam infusion.

Primary Outcome Measures: Intraoperative remifentanil dose, Intraoperative remifentanil dose will be measured at anesthesia day 0., At anesthesia day 0
Secondary Outcome Measures: Intraoperative remimazolam dose, Intraoperative remimazolam dose will be measured at anesthesia day 0., At anesthesia day 0|Pain score (0:no pain, 10:maximal pain), Pain score (0:no pain, 10:maximal pain) will be measured at anesthesia day 0 and 1., At anesthesia day 0 and 1|Electroencephalography, The relative power of alpha, beta, delta, gamma, and theta band in electroencephalography will be measured at anesthesia day 0., At anesthesia day 0
the DISC-OVARY Trial
NCT Number: NCT06497270
Acronym: DISC-OVARY
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: BRCA Mutation|Estrogen Deficiency|Menopause Surgical|Menopause Related Conditions|Menopause, Premature|Ovary Cancer
Interventions: PROCEDURE: Theca and Granulosa Cell Isolation
Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sex: FEMALE
Age: ADULT
Enrollment: 3
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-07-01
Completion Date: 2027-06-01
Locations: DH Tumori Femminili, Roma, Italy

Summary:
Selecting theca and granulosa cells from removed ovaries of BRCA1/2mut patients undergoing Risk-reducing salpingo-oophorectomy (RRSO) and developing a 3D bioprinted hormone-producing bioprosthetic model. If efficacy and tolerability are confirmed in vivo, this bioprosthetic model might be used to replace hormones' production in BRCA mutated patients undergoing prophylactic surgery.

Primary Outcome Measures: oestrogens and progesterone's levels, (Unit: pg/mL for both hormones), minumum 3 months
Effect of Smartphone Overuse on Hand Strength and Function in Physical Therapy Students
NCT Number: NCT06497257
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Smartphone Addiction
Interventions: OTHER: Evaluating wrist flexor and extensor peak torque|OTHER: Evaluating functional disability|OTHER: Evaluating hand grip strength
Sponsor: Cairo University
Sex: ALL
Age: ADULT
Enrollment: 60
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-10
Completion Date: 2024-08-20
Locations: Nouran Mohamed Saad, Cairo, Egypt

Summary:
The present study aimed to measure wrist flexor and extensor muscle strength, hand grip strength, wrist pain and function in smartphone addicts and non-addicts

Primary Outcome Measures: Measurement of wrist flexor peak torque, It will be measured by the Biodex system 3 pro isokinetic dynamometer., 1 month|Measurement of wrist extensor peak torque, It will be measured by the Biodex system 3 pro isokinetic dynamometer., 1 month|Assessment of functional disability, It will be assessed by the patient-related wrist and hand evaluation (PRWHE) questionnaire., 1 month|Measurement of hand grip strength, It will be measured by a JAMAR Handheld Dynamometer., 1 month
Evaluation of the Effect of Micro-osteoperforation on the Rate of Bone Anchored Molar Distalization
NCT Number: NCT06497244
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Microosteoperforations
Interventions: PROCEDURE: micro osteo-perforation
Sponsor: Cairo University
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 18
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2023-09-10
Completion Date: 2024-12-30
Locations: Cairo university, Cairo, Egypt

Summary:
The primary aim of the current study was to evaluate three dimensionally, using digital models and cone beam computed tomography imaging, the effect of micro-osteoperforations on the rate of tooth movement in the first molar distalization.

Primary Outcome Measures: rate of molar distalization, Incremental rate of molar distalization every month by intra oral scan superimposition, 6 months|total molar distalization distance by mm between T6 and T0, Total distance moved by the molar after 6 months by intra oral scan superimposition and measure the linear difference in position 1st molar between T6 and T0 by mm, 6 months
Secondary Outcome Measures: The effect of MOPs on Maxillary 1st molar tipping by degrees between T6 and T0, comparing the pre- \& post- distalization CBCT and measure the angular change in the 1st molar long axis tipping by degree between T6 and T0, 6 months|The effect of MOPs on Maxillary 1st molar rotation by degrees between T6 and T0, comparing the pre- \& post- distalization digital models and CBCT and measure the angular change in the 1st molar long axis rotation by degree between T6 and T0, 6 months|The effect of MOPs on Maxillary 1st molar vertical movement by mm between T6 and T0, comparing the pre- \& post- distalization CBCT and measure the linear change in the 1st molar vertical position by mm between T6 and T0, 6 months|The effect of MOPs on 1st molar root resorption level by mm between T6 and T0, comparing the pre- \& post- distalization CBCT and measure the amount of root resorption of 1st molar roots by mm between T6 and T0, 6 months|Detecting any Pain or discomfort caused by the micro-osteoperforations using Numeric pain rating scale, using Numeric Pain Rating Scale filled by the patient with minimum value is zero and maximum value 10 (the higher score mean worse outcome), 1 week
Smartphone-Based Neurobehavioral Assessments as a Diagnostic Aid in Autism
NCT Number: NCT06497218
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Autism Spectrum Disorder
Interventions: DIAGNOSTIC_TEST: Blinklab diagnostic device
Sponsor: Blinklab Limited
Collaborators: Mohammed VI National Center for the Disabled, Salé, Morocco
Sex: ALL
Age: CHILD
Enrollment: 450
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2023-05-15
Completion Date: 2025-01-15
Locations: Mohammed VI National Center for the Disabled, Sale, Morocco

Summary:
Retrospective case-control study to assess the diagnostic accuracy in autism spectrum disorder (ASD) of a new smartphone-based platform designed to conduct neurometric evaluations by measuring facial and behavioural reflexes.

Primary Outcome Measures: Device Sensitivity, Measure of the proportion of children truly having ASD who are correctly identified by the device as Positive for ASD relative to a formal DSM-5 diagnosis, at baseline|Device Specificity, Measure of the proportion of children truly not having ASD (who had no prior psychiatric diagnosis) who are correctly identified by the device as Negative for ASD, at baseline
Secondary Outcome Measures: Screen Avoidance, The percentage of trials wherein the child was avoiding the smartphone's screen and camera, at baseline|Anteroposterior Postural Stability, The child's anteroposterior postural stability, at baseline|Head Rotations, The percentage of trials wherein the child was rotating their head, at baseline|Headphone Touches, The percentage of trials wherein the child was touching the headphone, at baseline|Mouth Opening, The size and timing of the child's mouth openings and closings, at baseline|Vocalizations, The percentage of trials wherein the child was vocalizing and the corresponding time of occurrence, at baseline|Acoustic Startle Response (ASR), Difference in the amplitude of the eyelid ASR between the ASD and neurotypical children, at baseline|Long-term habituation (long-term HAB), Levels of habituation of the ASR over the course of the 15-minute test, at baseline|Prepulse inhibition (PPI), Reduction in the amplitude of the eyelid startle response due to prepulse stimuli, at baseline|Short-term habituation (short-term HAB), Habituation in the mean amplitude of eyelid startle responses over the course of the six startle pulses, at baseline|Anticipatory eye blinks (AEB), The anticipatory eye blinks (AEB) in predefined observation windows (OW) containing an omitted pulse. AEB were responses that were not triggered by the startle stimulus itself but rather by the expectation of an upcoming startle stimulus, at baseline
AMBulatory Fetal ECG Monitoring in Low and High-Risk Pregnancies
NCT Number: NCT06497205
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Pregnancy Related
Sponsor: Biorithm Pte Ltd
Sex: FEMALE
Age: ADULT
Enrollment: 180
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-03-19
Completion Date: 2025-08-31
Locations: St Georges University Hospital, London, Tooting, SW17 0QT, United Kingdom

Summary:
This study is a planned research project to test and demonstrate the feasibility of using the Femom device for monitoring fetal heart rate remotely.

The main goal is to learn if the remote recordings using Femom provide reliable information about the baby's heart rate. We will also establish reference standards of heart rate variability in uncomplicated pregnancies at different stages of pregnancy. Additionally, we will compare the heart rate variability in FGR and diabetic pregnancies to normal pregnancies.

Primary Outcome Measures: FHR, FHR agreement between Femom system and standard of care (CTG), 60 minutes|MHR, MHR agreement between Femom system and standard of care (CTG), 60 minutes
Examination of Occupational Justice, Activity Performance and Quality of Life in Homeless People
NCT Number: NCT06497192
Status: ACTIVE_NOT_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Homeless Persons
Sponsor: Bezmialem Vakif University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 14
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-01
Completion Date: 2024-09
Locations: Bezmialem Vakıf Üniversitesi, Istanbul, Turkey

Summary:
This concerns the participation of individuals experiencing homelessness, as a disadvantaged group, in meaningful and purposeful occupations, evaluated within the framework of occupational justice. Homeless individuals face numerous social and economic barriers that impact their full participation in societal occupations. However, since survival becomes the primary goal for homeless individuals, meaningful occupations often revolve around surviving on the streets. The aim is to identify problems and constraints to participation in daily life activities so that their participation can be enhanced.

Primary Outcome Measures: Demographic Information Form, Measures Demographic Information. It is a form that includes qualitative questions and checklists to assess individuals' current status regarding demographic data such as age, gender, education level, etc., Temel|Semi-Structured Interview Guide, Measures living conditions. It includes 4 open-ended questions., Temel|Canadian Occupational Performance Measure, Measures Occupational Performance. Self-care, productivity, and leisure constitute three sections. In the initial stage of evaluation, daily life activities identified by the individual are assessed in order of importance on a scale of 1 to 10 (1: not important at all, 10: very important). In the next stage, the individual selects the five most important activities for themselves and is asked to determine performance and satisfaction scores for each activity using a Likert scale from 1 to 10 (1: very poor performance / very dissatisfied, 10: very good performance / very satisfied). The obtained performance and satisfaction scores are summed and divided by the number of activities identified as important by the individual to obtain the performance and satisfaction scores., Temel|Occupational Justice Health Survey, Measures Occupational Justice. It is a five-section assessment tool comprising a total of 27 items, addressing fundamental needs, social, physical, and mental well-being, standards of living, and specific injustices that reduce occupational engagement., Temel|World Health Organization Quality of Life Scale Short Form, Measures Quality of Life. Since each domain independently represents the quality of life in its own area, domain scores are calculated between 4 and 20. As scores increase, life quality improves., Temel
Examining of Occupational Balance, Executive Functions, and Quality of Life of Adolescents With Internet Gaming Disorder
NCT Number: NCT06497166
Status: ACTIVE_NOT_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Internet Addiction Disorder
Sponsor: Bezmialem Vakif University
Sex: ALL
Age: CHILD, ADULT
Enrollment: 62
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-01
Completion Date: 2024-09
Locations: Bezmialem Vakif University, Istanbul, Turkey

Summary:
Internet gaming disorder leads to social problems and isolation, neglect of daily responsibilities, behavioral disorders, and cognitive and physical impairments. It is thought that assessing the occupational profiles and cognitive functions of adolescents with internet gaming disorder will bring a new perspective to the occupational therapy literature. The aim of the present study is to examine the occupational balance, executive functions, and quality of life of adolescents with internet gaming disorder.

Primary Outcome Measures: Adolescent Occupational Balance Scale, The scale measures occupational balance. According to the four-point Likert rating, the lowest raw score to be taken from the scale is 27, and the highest raw score is 108. It takes approximately 15-20 min to respond to the whole scale. A high score obtained from the scale indicates a high level of occupational balance., Baseline|Teenage Executive Functioning Inventory, The scale measures executive functioning. It is a 5-point Likert type inventory and includes statements scored from 1 to 5 (1: Definitely not true, 5: Definitely true). Higher scores represent more difficulty with executive functions. The lowest score to be taken from the scale is 20, and the highest score is 100., Baseline|Pediatric Quality of Life Inventory, The scale measures quality of life. It is a 23-item measurement tool. Items are reverse-scored and linearly transformed to a 0-100 scale (0 = 100, 1 = 75, 2 = 50, 3= 25, 4 = 0), so that higher scores indicate better quality of life. This instrument yields a Total score, Physical Health Summary score (Equivalent to the Physical Functioning subscale) and Psychosocial Health Summary score (Based on the Emotional Functioning subscale, Social Functioning subscale, and School Functioning subscale). The lowest score to be taken from the scale is 0, and the highest score is 100., Baseline|Internet Gaming Disorder Scale, The scale measures internet gaming disorder severity. The lowest score that can be obtained from the scale is 20 and the highest score is 100. Higher scores indicate a more severe disorder., Baseline|Sociodemographic Information Form, Measures sociodemographic information, Baseline