pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Wheelchair Basketball and Attention Training
NCT Number: NCT06565130
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Physical Disability
Interventions: OTHER: Attention skills training
Sponsor: Bezmialem Vakif University
Sex: ALL
Age: ADULT
Enrollment: 9
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-03-12
Completion Date: 2023-10-20
Locations: Bezmialem Vakif University, Istanbul, 34025, Turkey

Summary:
The goal of this interventional study is to evaluate the effect of attention training on performance in wheelchair basketball players. The main question it aims to answer is:

Does attention training have an effect on the performance of wheelchair basketball players? Participants will participate attention training from an occupational therapy perspective.

Primary Outcome Measures: The number of successful shots, The number of mistakes made during the physical activity and track will be recorded as one.Athletes can make mistakes at any stage of the course (depending on their attention skills). Each mistake will be considered a numerical unit and will be written as one piece., 10 week
Secondary Outcome Measures: The time to complete the track and each stage, The time spent by athletes on each stage of the track and the time it takes to complete the physical activity will be recorded. These times will be considered as a outcome measures., 10 week
Efficacy of Dipotassium Glycyrrhizinate Emollients in the Maintenance Treatment of Adult Atopic Dermatitis
NCT Number: NCT06565117
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Adult Atopic Dermatitis
Interventions: DRUG: White yu green skin lotion
Sponsor: The Affiliated Hospital of Xuzhou Medical University
Sex: ALL
Age: CHILD, ADULT
Enrollment: 120
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2021-10-01
Completion Date: 2023-02-01
Locations: The Affiliated Hospital of Xuzhou Medical University, Xuzhou, Jiangsu, 221002, China

Summary:
To investigate whether emollients containing dipotassium glycyrrhizinate have a sustained improvement in the clinical severity of mild to moderate atopic dermatitis in adult.

Primary Outcome Measures: SCORAD, Objective severity of the clinical signs of atopic dermatitis, Before treatment, Treatment for 2 weeks, 4 weeks, and 8 weeks|POEM, Patient-oriented eczema measurement scores, Before treatment, Treatment for 2 weeks, 4 weeks, and 8 weeks|NRS, Pain digital score, Before treatment, Treatment for 2 weeks, 4 weeks, and 8 weeks|ADCT, Long-term disease control, Before treatment, Treatment for 2 weeks, 4 weeks, and 8 weeks|DLQI, Quality of life index in dermatology, Before treatment, Treatment for 2 weeks, 4 weeks, and 8 weeks
Clinical Investigation for a Multifunction Ophthalmic Measurement Device
NCT Number: NCT06565091
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Accommodation Disorder|Keratoconus|Dry Eye|Refractive Errors|Accommodative Fatigue|Accommodative Inertia|Aberration, Corneal Wavefront
Interventions: DEVICE: Measurements of physiological parameters of the anterior chamber|DEVICE: Measurements of the Axial biometry
Sponsor: Essilor International
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 378
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-06-10
Completion Date: 2025-08
Locations: West Ophta, Rennes, 35000, France

Summary:
The purpose of this clinical investigation is to evaluate the clinical utility of a multifunctional measuring device for Ophtalmology.

The results of this clinical investigation will be used to refine and validate the device design.

378 participants total will be included in the trial, each having only one visit at the investigation center.

Primary Outcome Measures: Relative frequency of successful acquisition for each measurement of the investigational device, One day (measurements are taken during the single visit)
A Database Survey to Evaluate the Safety of Immune Globulin Subcutaneous (Human), 20% Solution in Participants With Primary Immunodeficiency
NCT Number: NCT06565078
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Primary Immunodeficiency Diseases (PID)
Interventions: DRUG: Immune Globulin Subcutaneous (Human), 20% Solution
Sponsor: Takeda
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-23
Completion Date: 2030-07-31

Summary:
This study is a retrospective database study in Japan to evaluate the safety of Immune Globulin Subcutaneous (Human), 20% Solution in participants with primary immunodeficiency disease (PID). This survey will conduct in use of medical database called PIDJ2.

Primary Outcome Measures: Number of Participants Who Experience Anaphylactic Reaction as an Adverse Event (AE), An AE is defined as any untoward event that occurred in a participant after the first dose of study drug, which does not necessarily have a causal relationship with primary immunodeficiency disease. Number of participants who experience anaphylactic reaction as an AE will be reported., From initial registration in the database or first dose of study drug, whichever came late, up to end date of data period (up to 5 years)|Number of Participants Who Experience Thromboembolism as an AE, An AE is defined as any untoward event that occurred in a participant after the first dose of study drug, which does not necessarily have a causal relationship with primary immunodeficiency disease. Number of participants who experience thromboembolism as an AE will be reported., From initial registration in the database or first dose of study drug, whichever came late, up to end date of data period (up to 5 years)|Number of Participants Who Experience Aseptic Meningitis as an AE, An AE is defined as any untoward event that occurred in a participant after the first dose of study drug, which does not necessarily have a causal relationship with primary immunodeficiency disease. Number of participants who experience aseptic meningitis as an AE will be reported., From initial registration in the database or first dose of study drug, whichever came late, up to end date of data period (up to 5 years)
A Safety and Effectiveness Study of the Supira System in Patients Undergoing HRPCI - CE Study
NCT Number: NCT06565039
Acronym: SUPPORT CE
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Ventricular Assist Device
Interventions: DEVICE: Supira System
Sponsor: Supira Medical
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 135
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2025-01
Completion Date: 2026-09

Summary:
The objective of this study is to evaluate the safety and effectiveness of utilizing the Supira System to provide hemodynamic support during HRPCI.

Primary Outcome Measures: Successful initiation and maintenance of hemodynamic support, A composite endpoint of safety and effectiveness outcomes, evaluated at 90 days, comprises the following outcomes:

* All-cause death
* Myocardial infarction (MI)
* Stroke or transient ischemic attack (TIA)
* Unplanned repeat revascularization
* Major bleeding (BARC ³ 3)
* Major vascular complications (MCS-ARC defined)
* Sustained hypotension during mechanical circulatory support, 90 days from procedure
Secondary Outcome Measures: Procedural Success, Freedom from:

1. Major bleeding (BARC ³ 3)
2. Major vascular complications (MCS-ARC defined)
3. Sustained hypotension during mechanical circulatory support
4. Need for mechanical circulatory support beyond the index procedure, 90 days from procedure
CS-101 in Patients With Sickle Cell Disease
NCT Number: NCT06565026
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: EARLY_PHASE1
Conditions: Sickle Cell Disease
Interventions: GENETIC: CS-101
Sponsor: CorrectSequence Therapeutics Co., Ltd
Collaborators: First Affiliated Hospital of Guangxi Medical University
Sex: ALL
Age: CHILD, ADULT
Enrollment: 5
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-30
Completion Date: 2027-06-30
Locations: The First Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi, China

Summary:
The goal of this open label, single-arm clinical study is to learn about the safety and efficacy of CS-101 injection in treating sickle cell disease.

Primary Outcome Measures: AEs(Adverse Events) and SAEs(Serious Adverse Events) after CS-101 infusion, Frequency and severity of adverse events(AEs）as assessed by CTCAE(Common Terminology Criteria for Adverse Events)v5.0, From signing informed consent to 24 months post-CS-101 infusion|Incidence of transplant-related mortality, Incidence of transplant-related mortality(Transplant-related mortality events defined as deaths assessed by the investigator as potentially transplant-related), From baseline to 100 days and 12 months post-CS-101 infusion|Time to neutrophil engraftment, Time to neutrophil engraftment is defined as first day of 3 consecutive measurements of absolute neutrophil count≥0.5×10\^9/L on three different days., Up to 24 months post-CS-101 infusion|Time to platelet engraftment, Time to platelet engraftment is defined as first day of 3 consecutive measurements of absolute platelet count≥20×10\^9/L on three different days and without platelet transfusion., Up to 24 months post-CS-101 infusion|All-cause mortality, Up to 24 months post-CS-101 infusion|Free from severe VOCs for 12 consecutive months (VF12), Free from severe vaso-occlusive crises (VOCs) for 12 consecutive months (VF12), starting 60 days after the last red blood cell transfusion up to 24 months
Secondary Outcome Measures: Free from hospitalization due to severe vaso-occlusive crises for 12 consecutive months(HF12), starting 60 days after the last red blood cell transfusion up to 24 months|Free from severe VOCs for 9 consecutive months (VF9), Free from severe vaso-occlusive crises (VOCs) for 9 consecutive months (VF9), starting 60 days after the last red blood cell transfusion up to 24 months|Annualized incidence of severe vaso-occlusive crises (VOC), starting 60 days after the last red blood cell transfusion up to 24 months|Annualized incidence of hospitalization due to severe vaso-occlusive crises, starting 60 days after the last red blood cell transfusion|HbF (fetal hemoglobin) level in blood samples, up to 24 months post-CS-101 infusion|Proportion of edited alleles in peripheral blood leukocytes and bone marrow cells, and persistence and chimerism kinetics evaluation, up to 24 months post-CS-101 infusion
IMPACT of an Instrumented Measurement on a Performance Assessment in Cerebral Palsy Treatment
NCT Number: NCT06565000
Acronym: IMPACT²
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cerebral Palsy
Interventions: OTHER: AHA Not Instrumented then AHA Instrumented|OTHER: AHA Instrumented then AHA Not Instrumented
Sponsor: Centre Médico-Chirurgical de Réadaptation des Massues Croix Rouge Française
Sex: ALL
Age: CHILD
Enrollment: 18
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: OTHER
Start Date: 2023-09-18
Completion Date: 2024-06-30
Locations: CMCR des Massues, Lyon, 69322, France

Summary:
The goal of this study is to assess the impact of passive reflective markers on bimanual performance assessment scores in children with unilateral cerebral palsy.

The main questions it aims to answer are:

* Is it possible to instrument performance assessment without changing the functionnal behaviour of the patient ?
* How is this behavious modified ?

During their usual occupational therpy assessment at the CMCR Massues, participants will do a second bimanual performance assessment with passive reflection markers taped on their trunk, humerus and forearm.

The glocal scores and sub items scors of both instrumented and non instrumented assessment will be compared.

Primary Outcome Measures: Bimanual Performance Score, The score of the participant at the Assisting Hand Assessment., 1 day
Risk of Nerve Damage After Administration of Local Anesthesia
NCT Number: NCT06564987
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Inferior Alveolar Nerve Injuries
Interventions: DRUG: 4% Articaine with 1:200,000 epinephrine|DRUG: 2% lidocaine with 1:100,000 epinephrine
Sponsor: Cleveland Dental Institute
Sex: ALL
Age: ADULT
Enrollment: 80
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-01-01
Completion Date: 2025-03-31
Locations: Cleveland Dental Institute, Akron, Ohio, 44703, United States|Cleveland Dental Institute, Ashtabula, Ohio, 44004, United States

Summary:
This research aims to evaluate of the risk of nerve damage following the administration of articaine 4% and lidocaine 2% for Inferior Alveolar nerve Block (IANB). A Randomized Controlled Clinical Trial will be conducted where the patient will be randomly assigned to one the two groups; articaine 4% and Lidocaine 2%. The type of LA will be concealed to the operator, investigators and assessors. The patients will be monitored for any aigns of nerve parathesia for 3 months after the procedure.

Primary Outcome Measures: Electromyograph, Signs of loss of sensation in the involved side of the jaw will be recorded using a tool called Electromyograph machine to evaluate and record Nerve conduction velocity, the scale is as follow Normal (grade 0) to extremely damage of (grade 6) while a patient rate pain intensity on a Visual Analogue Scale (VAS)., 3 months
Clomiphene Citrate in Infertile Men With Idiopathic Oligoasthenozoospermia
NCT Number: NCT06564961
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Infertility, Male
Interventions: DRUG: Clomiphene Citrate|DRUG: Placebo
Sponsor: Shakeela Ishrat
Sex: MALE
Age: ADULT
Enrollment: 50
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2022-07-01
Completion Date: 2023-12-31
Locations: Bangabandhu Sheikh Mujib Medical University, Dhaka, 1200, Bangladesh

Summary:
The goal of this clinical trial is to learn if drug clomiphene citrate improves sperm parameters in infertile men with idiopathic oligoasthenozoospermia. It will also learn about the safety of clomiphene citrate. The main questions it aims to answer are:

* Does drug clomiphene citrate change sperm count and motility in infertile men with idiopathic oligoasthenozoospermia?
* What medical problems do participants have when taking drug clomiphene citrate? Researchers will compare drug clomiphene citrate to a placebo (a look-alike substance that contains no drug) to see if drug clomiphene citrate works to treat idiopathic oligoasthenozoospermia.

Primary Outcome Measures: Change from baseline in sperm motility at 12 weeks, Sperm motility was percentage of progressive \& non-progressive motility, Baseline and 12 weeks|Change from baseline in sperm count at 12 weeks, Sperm count was in million per milliliter of semen, Baseline and 12 weeks
Treatment for Individuals Interacting With the Criminal Justice System
NCT Number: NCT06564948
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Suicide Risk|Psychiatric Disorders
Interventions: OTHER: Treatment as usual (TAU)|OTHER: Family and Social Justice|OTHER: Family and Social Justice Service and Navigator (FSJS+Navigator) Intervention
Sponsor: Cambridge Health Alliance
Collaborators: Michigan State University|Mount Auburn Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 2390
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2025-01-01
Completion Date: 2027-09-30

Summary:
The proposed Center will leverage burgeoning real-time data linkage capabilities among health systems, Medicaid payors, and criminal justice (e.g., jail booking data, jail release data) systems, to flag individuals coming in and out of jail for suicide assessment and prevention, and to better coordinate care across these disparate systems. This Center will advance the fields of suicide prevention and justice mental health by solving a well-known, central problem in both fields: the inability to track and intervene with individuals moving in and out of both and often multiple systems. The goal is near-term reductions in the U.S. suicide rate.

Primary Outcome Measures: Past-year medically treated suicide attempt at baseline and 12 months, Number of participants with a past-year medically treated suicide attempt. This will be measured at baseline and 12 months will be collected using the electronic health record (EHR) data., Baseline and 12 months|Assessing Suicide Severity and Behaviors using Computerized Adaptive Test Suicide Scale (CAT-SS) at Baseline and 12 Months, The CAT-SS measures Severity of Suicide Risk will be assessed using CAT-SS, providing severity on a 0-100 point scale, and risk-stratification to negligible, intermediate and high risk. It is highly sensitive and specific to the Columbia Suicide Severity Rating Scale, and predicts future suicide events with high precision and accuracy., Baseline and 12 months
Secondary Outcome Measures: Number of Individual Interactions with the Criminal Legal System at Baseline and 12 Months, Number of calls about each individual to the Cambridge Police Department (CPD) Number of arrests Number of admissions to the Middlesex County Jail Repeat admission to the Middlesex County Jail, From enrollment through 12 months|Number of Individual Interactions between Hospitals and the Criminal Justice System at Baseline and 12 Months, Number of involuntary hospitalizations that require Cambridge Police Department (CPD) interaction, From enrollment through 12 months|Frequency of Healthcare Services Used by Patients at Baseline and 12 Months, Number of Emergency Department visits Number of behavioral health inpatient visits Number of behavioral health outpatient mental health (MH) visits, From enrollment through 12 months
Preoperative Oral Heptaminol Hydrochloride in Preventing Hypotension After Spinal Anesthesia
NCT Number: NCT06564935
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Hypotension After Spinal Anesthesia
Interventions: DRUG: Heptaminol Hydrochloride|DRUG: Placebo
Sponsor: Cairo University
Sex: ALL
Age: ADULT
Enrollment: 160
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-08
Completion Date: 2025-03

Summary:
Methodologies and approaches have been implemented with differing degrees of success to prevent neuraxial hypotension. Currently utilized approaches to prevent hypotension during spinal anesthetic administration consist of physical precautions such as leg restraints and compression hosiery, as well as sympathomimetic medications Through a competitive inhibition of noradrenaline uptake, heptaminol hydrochloride prevented orthostatic hypotension and increased the plasma concentration of noradrenaline. This inhibitory effect might account for a portion of the antihypotensive effect After thorough research of the literature, studies evaluating the role of preoperative oral heptaminol hydrochloride in preventing hypotension after spinal anesthesia in lower limb surgeries with tourniquets are lacking.

Primary Outcome Measures: Hypotension, The occurrence of hypotension is defined as SBP \<90 mm Hg or \<80% of baseline, after spinal anesthesia. Our hypotension outcome was a binary event (yes/no) defined as the occurrence of at least 1 episode for a patient below either threshold, versus none, across the repeated measurements., It will be assessed in the first 20 minutes after spinal anaesthesia
Secondary Outcome Measures: Changes in mean arterial blood pressure after spinal anesthesia, Duration measurement of serial changes in mean arterial blood pressure after spinal anesthesia, Every 5 minutes in the first 20 minutes after spinal anesthesia then every 15 minutes until the end of operation assessed up to 3 hours after spinal anesthesia|Changes in heart rate after spinal anesthesia, Duration measurement of serial changes in heart rate after spinal anesthesia, Every 5 minutes in the first 20 minutes after spinal anesthesia then every 15 minutes until the end of operation assessed up to 3 hours after spinal anesthesia
Other Outcome Measures: Requirements of ephedrine, The total requirements of ephedrine to treat hypotension, From the time of intrathecal injection of the anesthetic drug until the end of operation after spinal anesthesia assessed up to 3 hours after spinal anesthesia|Requirements of Atropine, The total requirements of ephedrine to treat bradycardia, From the time of intrathecal injection of the anesthetic drug until the end of operation after spinal anesthesia assessed up to 3 hours after spinal anesthesia
Effects of Individualized Immediate Postnatal Counselling on Exclusive Breast Feeding
NCT Number: NCT06564922
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Breast Feeding|Counselling
Interventions: OTHER: Counselling
Sponsor: Bule Hora University
Sex: FEMALE
Age: ADULT
Enrollment: 221
Study Design: Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2023-01-01
Completion Date: 2023-05-01
Locations: Bule Hora and Yabelo Hospital, Bulē, Oromia, Ethiopia

Summary:
Breastfeeding is crucial for the health of both mothers and infants, promoting healthier populations and reducing long-term healthcare costs. To maximize these benefits, education, support, and effective policies are essential. This study aimed to evaluate the impact of immediate postpartum counseling on early initiation and exclusive breastfeeding rates in the pastoralist areas of Oromia, Ethiopia.

Hypothesis: Individualized immediate postnatal counselling improve exclusive breastfeeding practice.

Primary Outcome Measures: Early initiation of breastfeeding, Mothers will be asked about their infant breastfeeding practices, specifically regarding the early initiation of breastfeeding. The practice of early infant breastfeeding initiation will be determined using the operational definition of those who started breastfeeding within one hour after birth, while those who did not initiate breastfeeding within the first hour will be categorized accordingly., up to 1month
Secondary Outcome Measures: Breastfeeding frequency, Frequency of breast-feeding: This section describes the practice of mothers feeding their infants breast milk on demand. In this study, instances where mothers fed their babies according to their needs and the program guidelines were coded as "0," while instances where babies required feeding were coded as "1." Therefore, a code of "1" indicates that the mother frequently breastfed, whereas a code of "0" indicates that she did not frequently breastfeed., up to 1 month|Mother knowledge and attitude, Knowledge was assessed by evaluating their understanding of the benefits of breastfeeding for both themselves and their newborns. This evaluation involved eight specific questions. Mothers who answered at or above the mean score were classified as knowledgeable, while those who scored below the mean were considered not knowledgeable.

Attitude: This study assesses attitudes through 10 questions on a five-point likert scale ranging from "strongly agree" to "strongly disagree." Responses are then simplified into a two-point scale (agree or disagree), with "1" assigned for agreement on positive questions and "0" for disagreement. The reverse applies for negative questions. A positive attitude is indicated by responses that meet or exceed the mean score for breastfeeding items, while scores below the mean indicate a negative attitude., up to 1 month
Effect of L-Carnitine on Biomarkers of Myocardial Reperfusion Injury in Patients With STEMI
NCT Number: NCT06564909
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Reperfusion Injury, Myocardial|Myocardial Infarction
Interventions: DRUG: L-Carnitine|DRUG: The standard care for the management of myocardial infarction post PCI
Sponsor: Ain Shams University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 76
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-10
Completion Date: 2025-10

Summary:
The study aims is to evaluate the efficacy and tolerability of L-Carnitine on biomarkers of myocardial reperfusion injury in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary PCI by the assessment of nitrotyrosine as an oxidative stress marker and Matrix metallopeptidase-2 (MMP-2) as a cardiac fibrosis marker

Primary Outcome Measures: Evaluation of the marker nitrotyrosine, Measuring serum concentration of nitrotyrosine as an oxidative stress marker, 24 hours post PCI|Evaluation of the marker (MMP-2), Measuring serum concentration of Matrix metallopeptidase-2 (MMP-2) as a cardiac fibrosis marker., 24 hours post PCI
Secondary Outcome Measures: Assessment of Thrombolysis in Myocardial Infarction (TIMI) flow, Grade 0: No perfusion Grade 1: Penetration without perfusion Grade 2: Partial perfusion Grade 3: Complete perfusion, 0-1 hour at the end of PCI|Assessment of Myocardial Blush Grade, Grade 0: No myocardial blush Grade 1: Minimal myocardial blush Grade 2: Moderate myocardial blush Grade 3: Normal myocardial blush, 0-1 hour at the end of PCI|Incidence of ST-segment resolution >70 by ECG, 60 minutes post PCI|Echocardiography, Assessment of Left Ventricular Ejection Fraction (LVEF) and left ventricular diastolic and systolic volumes, 4 weeks|Occurrence of Major Adverse Cardiac Events (MACE), mortality, rehospitalization, reinfarction, arrhythmias, arrest, etc, 4 weeks
Efficacy and Safety Study of DURVALUMAB Maintenance in Patients With Stage III Non-Small Cell Lung Cancer
NCT Number: NCT06564870
Acronym: DURVABREIZH
Status: ACTIVE_NOT_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Bronchial Cancer
Sponsor: University Hospital, Brest
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Observational Model: |Time Perspective: p
Start Date: 2021-06-01
Completion Date: 2024-12-30
Locations: CHU de Brest, Brest, 29609, France

Summary:
The aim of this study is to evaluate the real-life efficacy of durvalumab treatment in consolidation after radio-chemotherapy.

Primary Outcome Measures: Real-life efficacy of durvalumab treatment in maintenance after chemoradiotherapy., progression-free survival, 1 year
Evaluating the Efficacy of a Single Layer Placental-based Allograft and Standard of Care Versus Standard of Care
NCT Number: NCT06564831
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Diabetic Foot Ulcer|Diabetic Foot|Foot Ulcer|Ulcer Foot
Interventions: OTHER: SLAM + SOC|OTHER: SOC
Sponsor: Applied Biologics, LLC
Collaborators: SerenaGroup, Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 124
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2025-08

Summary:
A Randomized Controlled Multicenter Clinical Trial, Evaluating the Efficacy of a Single Layer Placental-based Allograft and Standard of Care versus Standard of Care alone in the management of Nonhealing Diabetic Foot Ulcers

Primary Outcome Measures: The percentage of target ulcers achieving complete wound closure in 12 weeks., The percentage of target ulcers achieving complete wound closure in 12 weeks., 1-12 Weeks
Secondary Outcome Measures: The time to heal for target ulcers., Time to closure will be determined for each treatment group and compared to SOC., 1-12 weeks|Wound Area Reduction, Percentage wound area reduction from TV-1 to TV-13 measured weekly with digital photographic planimetry, using MolecuLight Imaging Device, and physical examination., 1-12 weeks|Adverse Events, Incidence of adverse events will be evaluated weekly from TV-1 to the healing confirmation visit (HCV)., 1-14 Weeks|Change in pain in the target ulcer, Change in pain in the target ulcer assessed using the PEG (pain, enjoyment in life, and general pain) scale. \[Time Frame: TV-1, 3 weeks, 6 weeks, 9 weeks, and 12 weeks or Final Visit\]., 1-12 weeks|Change in quality of life, Change in quality-of-life using the wQOL(Wound Quality of Life) questionnaire \[Time Frame: TV-1, 3 weeks, 6 weeks, 9 weeks, and 12 weeks or Final Visit\]., 1-12 weeks
Other Outcome Measures: Percentage of target ulcers achieving complete wound closure, Percentage of target ulcers achieving complete wound closure in 12 weeks for subjects 65 years of age or older., 1-12 weeks|Changes in chronic inhibitory bacterial load, Changes in chronic inhibitory bacterial load (CIBL) measured using fluorescence imaging., 1-14 weeks
A Study of a Psilocybin Analog (CYB003) in Humans With Major Depressive Disorder
NCT Number: NCT06564818
Acronym: APPROACH
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Major Depressive Disorder
Interventions: DRUG: CYB003|BEHAVIORAL: Psychological Support|DRUG: Placebo
Sponsor: Cybin IRL Limited
Collaborators: Worldwide Clinical Trials
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 220
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-11
Completion Date: 2026-05

Summary:
The purpose of this study is to examine the efficacy, safety, and tolerability of CYB003 compared to matching placebo as adjunctive treatment in participants with MDD.

Primary Outcome Measures: Montgomery-Åsberg Depression Rating Scale (MADRS), The MADRS is a 10-item scale with ratings based on a clinical interview which moves from broadly phrased questions about symptoms to more detailed ones allowing a precise rating of severity., Screening Day-45, Baseline Day-1, Day 2, Day 10, Day 21, Day 23, Day 31, and Day 42 (End of Treatment)
Secondary Outcome Measures: The Beck Depression Inventory-Second Edition (BDI-II), The Beck Depression Inventory-Second Edition (BDI-II) is a 21-question multiple-choice self-report inventory, assessing depressive symptoms and severity., Baseline Day-1, Day 21, and Day 42 (End of Treatment)|The Clinical Global Impression Scale (CGI-S), The Clinical Global Impression Scale is a clinician-rated instrument comprised of 3 global measures: severity of illness, global improvement, and efficacy index. Only the severity of illness and global improvement measures will be utilized for this trial., Screening Day-45, Baseline Day-1, and Day 42 (End of Treatment)|The Generalized Anxiety Disorder 7-item scale (GAD-7), The Generalized Anxiety Disorder 7-item scale (GAD-7) is a 7-item self-reported assessment that measures the severity of generalized anxiety disorder symptoms., Baseline Day-1, Day 21, and Day 42 (End of Treatment)|The Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF), The original Quality of Life Enjoyment and Satisfaction Questionnaire is a 93 item, participant facing, self-reported measure used to evaluate intervention-related changes in quality of life, divided into the following sections: physical health, feelings, work, household duties, school, leisure time activities, social relations, and general activities. The Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) version will be used in this trial., Baseline Day-1, Day 21, and Day 42 (End of Treatment)
Clinical Trial on the Efficacy of Intralesional Triamcinolone Versus Candida Albicans Antigen in Treating Alopecia Areata
NCT Number: NCT06564805
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Alopecia Areata
Interventions: DRUG: Candida Albicans Antigen Injection
Sponsor: Universidad Autonoma de Nuevo Leon
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-20
Completion Date: 2025-12-31
Locations: Hospital Universitario "Dr. José Eleuterio González", Monterrey, Nuevo León, 64460, Mexico

Summary:
The efficacy of two intralesional treatment modalities for alopecia areata will be determined. Thirty patients over the age of 6 with the diagnosis of alopecia areata on the scalp, with an extension of less than 50%, will be included. A comparison will be made between the effectiveness of intralesional Triamcinolone (standard first-line treatment) and intralesional Candida albicans antigen, with serial clinical and trichoscopic pictures at follow-up to evaluate the clinical response and associated adverse effects.

Primary Outcome Measures: Treatment response, porcentage of hair growth determined by SALT score, 5 months
Secondary Outcome Measures: Side effects, Side effects associated to the treatment, 5 months
Contingency Management in HIV Care for Both Stimulant Use & ART Adherence
NCT Number: NCT06564792
Acronym: CoMBo
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Stimulant Use (Diagnosis)|Hiv
Interventions: BEHAVIORAL: Contingency management
Sponsor: University of California, San Francisco
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 37
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-09-15
Completion Date: 2025-01
Locations: UCSF at San Francisco General Hospital, San Francisco, California, 94110, United States

Summary:
Methamphetamine use and associated sequelae have been rising, and represent a major barrier to successful control of the HIV epidemic. Methamphetamine use is associated with poor adherence to antiretroviral therapy for HIV, and we propose a trial of contingency management (providing incentives for behavioral change) targeting both reduced methamphetamine use and improved adherence to HIV medications. We will utilize a real-time, point-of-care urine assay for both outcomes, aiming to evaluate feasibility, acceptability and preliminary effectiveness of HIV care-based contingency management. We will also study hair levels as a quantitative outcome for reduction in methamphetamine use.

Primary Outcome Measures: Feasibility: proportion of CM visits attended, We will report multiple process measures as feasibility outcomes, though primary outcome is the number and proportion of contingency management visits attended (of 12). We expect that 50% of participants will attend at least 6 or more CM visits, which we will define as minimum engagement suggesting feasibility of this HIV primary care-based CM intervention., Measured during intervention participation.|Acceptability: in-depth interviews with participants, staff, We will conduct in-depth qualitative interviews to understand factors and circumstances that influence CM engagement among PWH with stimulant use disorder and suboptimal ART adherence. These findings will also help elucidate mechanisms contributing to stimulant use reduction and ART adherence when once weekly CM is delivered to PWH in a designated primary care setting., Interviews performed within 6 months of intervention participation.
Secondary Outcome Measures: Effectiveness (Urine), We will report proportion of urine tests negative for stimulants; proportion positive for tenofovir., Measured during intervention participation.|Effectiveness (Hair), We will correlate within-person changes in cumulative stimulant hair levels with the days free of stimulant use performed pre- vs. post-intervention using mixed effects Poisson regression with random effects for individual., Analyzed within 1 year following hair collection
Development, Standardisation and Standardisation Project for a New Memory Assessment
NCT Number: NCT06564779
Acronym: NEM
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Memory Disorders
Interventions: OTHER: New memory assessment
Sponsor: University Hospital, Tours
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 150
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-01
Completion Date: 2028-11-01
Locations: University hospital, Tours, 37044, France

Summary:
Episodic memory (EM) is a neuropsychological marker of Alzheimer's disease (AD) (Thomas-Anterion, 2006). Current tests for its assessment do not take into account the identity and emotional aspects of memory (Van der Linden et al., 2018). However, there are models that integrate links with identity, self-awareness and experience. Pause et al. (2013) propose criteria to create ecological tools, including consideration of the emotional valence of memories and the spatio-temporal context of acquisition. In line with these criteria, we have developed a new tool: the NEM (New evaluation of Episodic Memory). Preliminary studies show different response profiles on the NEM among patients (Launay et al., 2023). We now want to evaluate the relevance of this tool in the differential diagnosis of AD.

Primary Outcome Measures: Score total NEM (new memory assessment), Sum of the episodic elements, baseline
Secondary Outcome Measures: NEM sub-scores, Sum of the episodic elements by category, baseline|Total RL/RI 16 Recall, (Van der Linden et al., 2014), baseline|Delayed Mem Logic Recall, (MEM IV, Wechsler, 2014), baseline
Phase 2 Trials of NA-931 to Study Subjects Who Are Obese With at Least One Weight-related Comorbid Condition
NCT Number: NCT06564753
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Weight Loss|Obesity|Body Weight|Body Weight Changes
Interventions: DRUG: Drug: Placebo daily and orally|DRUG: NA-931, dose 1, daily and orally|DRUG: NA-931, dose2, daily and orally|DRUG: NA-931 dose 3, daily and orally|DRUG: NA-931 dose 4, daily and orally
Sponsor: Biomed Industries, Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 125
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-19
Completion Date: 2025-02-28
Locations: Biomed Investigational Site, Camperdown,, New South Wales, 2050, Australia|Biomed Investigational Site, Merewether, New South Wales, 2291, Australia|Biomed Investigational Site, St Leonards, New South Wales, 2065, Australia|Biomed Investigational Site, Heidelberg Heights,, Victoria, 3081, Australia|Biomed Investigational Site, Melbourne, Victoria, 3004, Australia

Summary:
This is a Phase 2 randomized, double-blind, placebo-controlled, parallel arm study of NA-931 in adults who are obese (BMI ≥30 kg/m2) or who are overweight (BMI ≥27 kg/m2) with at least one weight-related co-morbid condition.

Primary Outcome Measures: Percent (relative) change from baseline to Week 13 in body weight, To measure the efficacy of NA-931 for weight loss in adult subjects who are obese, or overweight with at least one weight-related comorbid condition, 13 weeks
Secondary Outcome Measures: Proportion of Subjects losing ≥5% and ≥10% of baseline weight at Week 13, To measure the efficacy of NA-931 for weight loss in adult subjects who are obese, or overweight with at least one weight-related comorbid condition, 13 weeks|Incidence of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse event (TESAEs), adverse events of special interest (AESI), To evaluate the safety and tolerability including treatment-emergent adverse events (TEAEs), TESAEs, AESI of NA-931 for weight loss in adult subjects who are obese, or overweight with at least one weight-related comorbid condition, 13 weeks
Uniportal VATS Resection for Pulmonary Aspergilloma : Evaluation of Prognostic Factors in a Single Center Experience
NCT Number: NCT06564727
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Pulmonary Aspergillosis|Surgery-Complications|Thoracic Diseases
Interventions: PROCEDURE: Uniportal VATS approach|PROCEDURE: VATS approach
Sponsor: Hassan II University
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 51
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2017-01-01
Completion Date: 2020-01-30
Locations: Hassan II University, Casablanca, 20000, Morocco

Summary:
The objective of this study was to report our experience with U-VATS resection and to evaluate our surgical outcomes with an analysis of postoperative complications. The investigators also estimate the prognostic factors that influence the morbidity and the conversion.

Primary Outcome Measures: postoperative complications, evaluate the complication at 30 days, 30 days
A Pediatric Comparison of Remote Microphone Technologies
NCT Number: NCT06564701
Status: ENROLLING_BY_INVITATION
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Hearing Loss
Interventions: DEVICE: Phonak Roger TouchScreen Microphone|DEVICE: Phonak Partner Mic
Sponsor: Sonova AG
Collaborators: Hearts for Hearing
Sex: ALL
Age: CHILD
Enrollment: 25
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-05
Completion Date: 2024-11-30
Locations: Hearts for Hearing, Oklahoma City, Oklahoma, 73120, United States

Summary:
Speech intelligibility will be evaluated for school age children with hearing loss in a simulated classroom environment, using Phonak hearing aids and receivers and two different microphone transmitters: a Roger Touchscreen mic and a fixed directional microphone.

Primary Outcome Measures: Speech Intelligibility score using the AZ Bio Sentence Test-teacher condition, Sentences are presented from a front speaker located 8.5 feet away from participant. Diffuse background noise is presented from four corner speakers. Various Signal to Noise Ratios (SNR) will be tested: +4 dB, +2 dB, and -2 dB. The number of words correctly repeated will be calculated and expressed as a percentage for each SNR level. A higher score is better., One day (Visit 1)|Speech Intelligibility score using the AZ Bio Sentence Test- small group condition, Sentences are presented randomly from three different speakers, located around a small table with the participant, simulating a small group at a table. Diffuse background noise is presented from four corner speakers. Various Signal to Noise Ratios (SNR) will be tested: +4 dB, +2 dB, and -2 dB. The number of words correctly repeated will be calculated and expressed as a percentage for each SNR level. A higher score is better., One day (Visit 1)
Secondary Outcome Measures: Listening Fatigue using the Vanderbilt Fatigue Scale for Children, Ten questions related to fatigue, answers rank from 1 (never) to 5 (almost always). Total scores can range from 10 to 50, with higher scores indicating more self-perceived fatigue., Two days (Visit 2 and Visit 3)|Subjective Preferences of participants, Participants will be asked to rank their preference for the microphone systems using a Likert type of rating scale (1-5), where a lower score (\<3) would indicate preference for the partner mic and a higher score (\>3) will indicate preference for the Roger Touchscreen., Two days (Visit 1 following the lab testing, and Visit 3, following the field trial)
To Explore the Functional Connectivity Pattern of Cortical Swallowing Network in the Oral Phase of Post-stroke Dysphagia Based on Dynamic Causal Modelling
NCT Number: NCT06564688
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Dysphagia After Stroke|Cortical Swallowing Network|Functional Magnetic Resonance Imaging|Oral Phase|Dynamic Causal Modelling
Interventions: DIAGNOSTIC_TEST: Swallowing function test
Sponsor: Fujian University of Traditional Chinese Medicine
Collaborators: Xiangyang Central Hospital, Affiliated Hospital of Hubei University of Arts and Science
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 72
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-20
Completion Date: 2025-07-01

Summary:
Swallowing activity in the oral phase is regulated by the cortical swallowing network, and the functional connectivity pattern of the cortical swallowing network is related to swallowing activity. The structural damage of the cortical swallowing network and abnormal activation of brain areas related to swallowing in post-stroke dysphagia affect swallowing activity. The recovery of dysphagia after stroke is related to the compensation of swallowing network in the contralateral hemisphere and different connectivity patterns of diseased brain areas, and the integrity of cortical swallowing network connectivity affects the sequence of oral swallowing activities. However, it is not clear how the functional connectivity patterns and interactions of brain regions of the cortical swallowing network related to oral swallowing activity change in patients with oral dysphagia after stroke.

Primary Outcome Measures: Standard Swallowing Assessment (SSA), The scale has a minimum score of 18 and a maximum score of 46, with higher scores indicating poorer swallowing function, Before fMRI scan|Oral Functional Scale, The Oral Functional Scale is a tool used to assess the oral functional status of an individual, with higher scores indicating better oral function, Baseline
Secondary Outcome Measures: Functional Oral Intake Scale (FOIS), The Functional Oral Intake Scale (FOIS) is a reliable and valid tool for assessing functional oral food and fluid intake in patients with oropharyngeal dysphagia (OD). Fois has seven levels, with higher levels indicating better swallowing function., Baseline
Other Outcome Measures: Videofluoroscopicdysphagia scale（VDS）, The VDS scale should be evaluated by videofluoroscopic swallowing study. The VDS has a total of 14 items, including 2 dimensions (oral phase and phase). Scores range from 0 to 100, with higher scores indicating greater severity of dysphagia., Baseline|Water Swallowing Test (WST), Water Swallow Test (WST) is a method to evaluate the swallowing function of patients by observing their swallowing movements and performance during drinking water., Baseline