pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Comparing The PK Of Aramchol Meglumine Granules To Aramchol Free Acid Tablets
NCT Number: NCT06502561
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Healthy
Interventions: DRUG: Aramchol meglumine|DRUG: Aramchol free acid
Sponsor: Galmed Pharmaceuticals Ltd
Sex: ALL
Age: ADULT
Enrollment: 16
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-10
Completion Date: 2025-04
Locations: Diagnostic & Consultative Centre 'Ascendent' Ltd., Sofia, 1202, Bulgaria

Summary:
This is a Phase 1 Relative Bioavailability Study Comparing The Pharmacokinetics Of Aramchol Meglumine Granules For Oral Suspension To Aramchol Free Acid 300 mg Tablets In Healthy Volunteers

Primary Outcome Measures: Cmax of Aramchol, Observed maximal concentration after administration, 10 weeks|AUClast of Aramchol, Area under the concentration/time curve, calculated by the trapezoidal rule from time 0 h to last observed concentration at time t, 10 weeks|AUCinf of Aramchol, Area under the concentration/time curve, from time 0 h extrapolated to infinity, 10 weeks
Secondary Outcome Measures: Tmax of Aramchol, Observed time point of maximal concentration, 10 weeks|λz of Aramchol, Terminal rate constant, 10 weeks|t½ of Aramchol, Plasma concentration half-life, 10 weeks|CL/F of Aramchol, Clearance per fraction of bioavailability, 10 weeks|VZ/F of Aramchol, Volume of distribution per fraction of bioavailability, 10 weeks|%AUCextrap of Aramchol, The percentage of the area under the concentration-time curve (%AUC) that is extrapolated beyond the last observed data point, 10 weeks
Endometriosis Transcriptomic Cell Atlas
NCT Number: NCT06502548
Acronym: EDISON
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Endometriosis|Infertility
Interventions: PROCEDURE: Endometriosis|PROCEDURE: Tubal ligation or Hysterectomy
Sponsor: University Hospital, Toulouse
Collaborators: Institut National de la Santé Et de la Recherche Médicale, France
Sex: FEMALE
Age: ADULT
Enrollment: 92
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-09-30
Completion Date: 2027-09
Locations: University Hospital Toulouse, Toulouse, France

Summary:
Endometriosis is an estrogen-dependent, chronic inflammatory gynecologic disease affecting women of reproductive age, with a therapeutic wandering of 6 to 10 years. A better understanding of the initiation phase is a major challenge to improve diagnosis and treatment. The most widely accepted hypothesis to explain the formation of endometriotic lesions is the tubal retrograde reflux during menstruation. However, only 10% of the reproductive age women will develop endometriosis while 90% of women experience retrograde menstruation. This raises the question of the stem cells present in the endometrium and menstrual reflux of these patients, but also of both the peritoneal microenvironment and the estrogenic local signaling which allow the implantation of these lesions.

Primary Outcome Measures: Analyze of the number of the different cell types (immune cells and endometrial stem cells) present in the endometrium of healthy control patients, During surgery|Analyze of the number of the different cell types (immune cells and endometrial stem cells) present in the peritoneal fluid of healthy control patients, During surgery|Analyze of the number of the different cell types (immune cells and endometrial stem cells) present in endometriosis lesions for endometriosis patients., During surgery|Analyze of the number of the different cell types (immune cells and endometrial stem cells) present in endometrium of endometriosis patients., During surgery
Behavioural Study in Chronic Pain : Creativity and Motivation, and Circuits Involved in Functional MRI
NCT Number: NCT06502496
Acronym: AART
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Chronic Pain
Interventions: BEHAVIORAL: art-therapy|BEHAVIORAL: relaxation
Sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 48
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2025-01
Completion Date: 2028-05

Summary:
Being creative means having the ability to produce ideas, actions or works that are original and different from what we have already done. This process involves mental flexibility, in particular the association of distant ideas or divergent thinking. This creative potential is complex and depends on a number of factors, both internal (personality, motivation, emotional state, stress) and external to the individual (socio-cultural context). The generation of creative ideas involves the fronto-striatal circuit, with a balance between flexibility and perseverance. The striatum is central to the reward system and mental flexibility, while the prefrontal cortex is involved in executive control, underpinning perseverance functions. Dopamine plays a key role in this balance, and changes in dopamine levels, depending on the type of receptor activated, will have a direct impact on the transition between mental flexibility and perseverance. Furthermore, in the context of chronic pain, changes in connectivity and activity can be observed in neuroimaging in these same regions of the reward circuit. This suggests that the dopaminergic system is also involved in the chronicisation of pain. The creative process would therefore be correlated with the dopaminergic reward system, involving several dimensions, both cognitive in terms of mental flexibility, coping strategies and perseverance, and motivational. In this context, art therapy treatments are beginning to be studied, particularly in patients suffering from Alzheimer's or Parkinson's disease, showing improvements in anxiety and depression.

Art therapy has not yet been widely proposed or studied for patients suffering from chronic pain. A more detailed behavioural study would confirm and clarify the clinical benefits for patients, by exploring the neuronal circuits involved, particularly the dopaminergic reward system.

Primary Outcome Measures: changes in performance to obtain a reward (reward-based learning task) between before the sessions and 1 to 2 weeks after the sessions, the reward learning ability will be assessed using a specific task. The result of the task questionnaire is a numeric score., Day0 and 1 to 2 weeks after the last session
PRISM for Depression and Anxiety in Young Adults With Cancer
NCT Number: NCT06502483
Acronym: PRISM
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cancer Diagnosis|Non-Metastatic Neoplasm|Anxiety|Anxiety Disorders|Depression|Depressive Disorder|Depression, Anxiety
Interventions: BEHAVIORAL: Promoting Resilience in Stress Management Program
Sponsor: Dana-Farber Cancer Institute
Sex: ALL
Age: ADULT
Enrollment: 15
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-08
Completion Date: 2025-07-01
Locations: Dana-Farber Cancer Institute, Boston, Massachusetts, 02215, United States

Summary:
This research study is being done to test the feasibility of an existing supportive program (PRISM) to address psychological symptoms (i.e., depressive and anxiety symptoms) that young adult participants diagnosed with cancer may experience.

The name of the intervention used in this research study is:

-Promoting Resilience in Stress Management (PRISM) Program

Primary Outcome Measures: Rate of PRISM Intervention Completion, Feasibility is defined as 70% of PRISM sessions are completed by participants who start the study., Up to 12 weeks|Rate of Study Assessment Completion, Study feasibility is defined as 70% of all study assessments are completed by participants who complete PRISM sessions., Up to 12 weeks|Participant Satisfaction, Acceptability of the PRISM intervention will be determined by responses on semi-structured exit interviews using descriptive statistics and scores on the Client Satisfaction Questionnaire- (CSQ-8), an 8-item measuring a participant's opinions and assessment of the intervention. Total scores range from 8 to 32 with a higher number indicating greater satisfaction., At final intervention session, up to 6 weeks
Secondary Outcome Measures: mPRISM Phone Application Usage, The feasibility of the mPRISM phone application as a tool to practice PRISM skills, as evidenced by the participant usage metrics., Up to 12 weeks|Questionnaires, The feasibility of using the assessment questionnaires in the current study (e.g., length, administration), Up to 12 weeks
Pain Management With Virtual Reality Hypnosis
NCT Number: NCT06502457
Acronym: PréVR
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Hypnosis|Labor Pain|Virtual Reality|Labor Induction|Latent Period
Interventions: DRUG: painkiller|OTHER: hypnosis group
Sponsor: Centre Hospitalier Universitaire, Amiens
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 142
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: OTHER
Start Date: 2024-07-09
Completion Date: 2025-08
Locations: CHU Amiens Picardie, Amiens, France

Summary:
The latency phase corresponds to the first phase of the first stage of labour, during which the parturient feels regular, rhythmic uterine contractions that are often painful, with or without changes of the cervix. This phase lasts an average of 8 hours for primiparous women, compared with 5 hours for multiparous women, and can last up to twenty hours in total.

Cervical ripening corresponds to the medical induction of regular, painful uterine contractions in order to obtain a favourable cervix for the induction of labour. Cervical ripening is carried out either medically (oral or local prostaglandins) or mechanically (double balloon dilatation) and accounts for 69.2% of labour inductions, which in turn account for 25.8% of births.

At Amiens-Picardie University Hospital, this maturation stage can last from a few hours to 2 days, depending on the service protocol.

What these two stages of childbirth have in common is that they are both painful, with very few analgesic drugs available that can be used without side-effects on the foetus during pregnancy.

In recent years, there has also been a growing demand from parturients for the use of non-medicinal therapies.

It therefore seems essential to provide parturients with as many effective non-drug methods as possible to manage their pain properly.

If virtual reality hypnosis sessions prove to be effective, they will provide better pain management for women in labour, reduce the use of morphine derivatives (with their attendant side-effects, particularly on the foetus), and above all meet the growing demand from women in labour for the most physiological possible support during childbirth.

Primary Outcome Measures: pain intensity difference between the first analgesic procedure and 30min later, Assessment of PID (pain intensity difference) between the first analgesic procedure and 30min later., 30 minutes
Secondary Outcome Measures: Average consumption of analgesics, Average consumption of analgesics (morphine agonists and other analgesics) during the latency or maturation period., 12 hours
Analysis of Disturbances in Neurofluid Dynamics in Type I Chiari Malformations
NCT Number: NCT06502431
Acronym: NEUROFLUX-C
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Type I Chiari Malformation|Cerebral Hemodynamic|Craniospinal Hydrodynamic|Phase Contrast MRI|Cerebrospinal Fluid
Interventions: OTHER: phase contrast sequences
Sponsor: Centre Hospitalier Universitaire, Amiens
Sex: ALL
Age: ADULT
Enrollment: 60
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: OTHER
Start Date: 2024-06-24
Completion Date: 2027-07
Locations: CHU Amiens Picardie, Amiens, Picardie, 80054, France

Summary:
A global analysis of craniospinal hemodynamics and hydrodynamics is necessary to better understand the pathophysiology of Chiari malformations. This includes an analysis of intraventricular CSF flow, intracranial subarachnoid spaces, foramen magnum, cervical subarachnoid spaces and within the syringomyelia cavity when present. The investigators will also analyze the pulsatility of the cerebellar tonsils in the foramen magnum. Hemodynamic analysis will be performed at the high cervical level (internal carotid and vertebral arteries, jugular veins) and intracranially (carotid and basilar arteries, right sinus and superior longitudinal sinus). This analysis will be made possible by PCMRI acquisitions with slice planes allowing the analysis of the dynamics of the CSF (mesencephalic aqueduct, prepontic cisterns, foramen magnum, at the level of the C2C3 disc, syringomyelia if present), cerebellar tonsils (foramen magnum). The cross-sectional planes for hemodynamic analysis will be at the level of the C2C3 disc (cervical vascular analysis) and upstream of the polygon of Willis (intracranial vascular analysis).

The goal is to complement the clinical and morphological investigations with quantitative imaging of cerebrospinal fluid (CSF) and blood flow in the craniospinal system. These flows are potentially altered or causes of this Chiari anomaly.

The investigators propose a translational research project of clinical research allowing the analysis of a diagnostic technique by a diagnostic, monocentric, prospective study. After neurosurgical consultation, patients with Chiari malformation will be assigned to a symptomatic Chiari malformation or a non-symptomatic Chiari malformation group. They will be offered to participate in this study after information and informed consent. The allocation between the two groups will be made according to the symptomatic or non-symptomatic nature of the Chiari malformation. After inclusion, the patients will have a morphological MRI and a PCMRI according to the determined slice plans and allowing a global analysis of the craniospinal hemohydrodynamics. Craniospinal hemohydrodynamics in a control population will also be analyzed using the same methodology by PCMRI.

Primary Outcome Measures: CSF Flow, Flow will be measured by the oscillatory volume expressed in mL/cardiac cycle., day 1|Blood Flow, Flow will be measured by the oscillatory volume expressed in mL/cardiac cycle., day 1
Acupuncture to Managed Pain During Induced Labor With Cook's Balloon
NCT Number: NCT06502418
Acronym: COOKACUPAIN
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Labor Induction
Interventions: OTHER: Acupuncture therapy
Sponsor: Centre Hospitalier de Roubaix
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 72
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-09
Completion Date: 2025-07

Summary:
In France, labor induction rate is above 25.8%. Labor induction with Cook's balloon is a non-hormonal mechanical method but this technique can provide pain.

At Roubaix's maternity, midewifes can adminitred acupuncture therapy to help to manage this pain.

No studies where found about an effect of acupuncture therapy on pain provoked by labor induction with Cook's balloon.

Primary Outcome Measures: Impact of 7 acupuncture points on pain, Assessment of pain with Visual Analogic Scale before and after the use of Cook's balloon, Day 1
Secondary Outcome Measures: Evaluate the consumption of analgesics between the 2 groups, datas of analgesics consumption will be collected in patient record, Day 1|Evaluate experiences of the patient during labor induction between the 2 groups, Use of questionnary, Day 1|Comparison of cesarean section rate, balloon failure rate and induction duration between the two groups, datas will be collected in patient record, Day 2
Research on the Application of Electrical Impedance Tomography in Bronchial Challenge Testing
NCT Number: NCT06502405
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Asthma
Sponsor: wang kaifei
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-01
Completion Date: 2025-06-30

Summary:
The purpose of this study was to examine whether electrical impedance tomography (EIT) was capable of identifying the deteriorated lung function on a regional level during bronchial challenge testing and whether EIT may provide additional information during bronchial challenge testing and identify spatial and temporal heterogeneity of regional lung function.

Primary Outcome Measures: global inhomogeneity index （GI）, Measured by EIT, used to describe the overall degree of spatial heterogeneity of ventilation., 1day|forced expiratory volume in 1s (FEV1), The forced expiratory volume in 1s measured during pulmonary function tests., 1day
Correlation Between Creatine Phosphokinase and Pelvic Floor Muscle Strength in Postnatal Women
NCT Number: NCT06502392
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Pelvic Floor; Rupture, Old (Postpartum)
Interventions: OTHER: Assessment of creatine phosphokinase|OTHER: Assessment of pelvic floor muscle strength
Sponsor: Cairo University
Sex: FEMALE
Age: ADULT
Enrollment: 84
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-20
Completion Date: 2024-09-20
Locations: Hadeer Mostafa, Giza, Egypt

Summary:
The purpose of this study is to determine the correlation between creatine phosphokinase and pelvic floor muscle strength in post-partum women.

Primary Outcome Measures: Assessment of creatine phosphokinase, It will be assessed through collecting a blood sample. The collected blood will be transferred into a sterile vacutainer tubes (9 mL) with anticoagulant and will be placed symmetrically into the centrifuge device. The serum will be separated from blood and will be put in epindoorf tubes and send immediately for analysis. Serum CPK will be quantitatively measured in units/liter (u/l) on a Vitros 950 automated analyzer shortly after the receipt of the specimen., It will be measured within the first six weeks after delivery (2nd-5th weeks).|Assessment of pelvic floor muscle strength, It will be assessed by a biofeedback. Women will be positioned comfortably for pelvic floor muscle (PFM) strength assessment using a TG Myo feedback 420v vaginal electrode. The electrode, properly prepared and inserted, will measure vaginal closure pressure and deep PFM strength. The therapist will explain the display and will establish a one-minute baseline, noting any inconsistencies. Women will perform three 10-second maximum contractions, with the mean of these readings to be recorded. Muscle strength will be measured by peak maximum pressure and ability to sustain contraction., It will be measured within the first six weeks after delivery (2nd-5th weeks).|Assessment of pelvic floor muscle endurance, It will be assessed by a biofeedback. Women will be positioned comfortably for pelvic floor muscle endurance assessment using a TG Myo feedback 420v vaginal electrode. The electrode will be properly prepared and inserted. The therapist will explain the display and will establish a one-minute baseline, noting any inconsistencies. Women will perform three 10-second maximum contractions. Muscle endurance will be measured as the time a sub-maximum contraction can be maintained before significant power reduction occurs., It will be measured within the first six weeks after delivery (2nd-5th weeks).
Plexaa For Preconditioning: Gender Affirming Mastectomy
NCT Number: NCT06502353
Acronym: P4PGAM
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Nipple Necrosis|Nipple Graft Loss
Interventions: DEVICE: BLOOM43
Sponsor: Plexaa Ltd
Collaborators: Stanford University
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 15
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-08-01
Completion Date: 2025-06-01
Locations: Division of Plastic & Reconstructive Surgery, Stanford University, Palo Alto, California, 94304, United States

Summary:
The goal of this clinical trial is to evaluate the use of the Plexaa preconditioning device (BLOOM43) in transgender and non-binary patients undergoing gender affirming mastectomy. This study aims to understand a participant's experience of the device, including its usability and acceptability.

Participants will use the device to precondition their right breast the evening before undergoing surgery (gender affirming mastectomy).

Primary Outcome Measures: Participant experience, Participants' experience of the device will be evaluated with the use of a questionnaire. Most of the questions will consist of multiple-choice components with a five-point scale and there will also be a section for further comments from participants., 30 days
Secondary Outcome Measures: Compliance, Proportion of participants who are compliant with the preconditioning protocol, 1 day|Nipple necrosis/nipple graft loss, Proportion of participants experiencing partial or complete nipple necrosis/nipple graft loss and the rate of hospital readmission due to this, 30 days
PERIOPERATIVE MYOCARDIAL DAMAGE IN ROBOT-ASSISTED SURGERY
NCT Number: NCT06502340
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Myocard Injury After Non Cardiac Surgery|Robotic Assisted Laparoscopic Radical Prostatectomy
Interventions: DIAGNOSTIC_TEST: high sensitive troponin I
Sponsor: Ankara City Hospital Bilkent
Sex: MALE
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 63
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-15
Completion Date: 2024-12-30

Summary:
Our study aimed to identify myocardial damage during or after robotic-assisted radical prostatectomy by measuring high-sensitive Troponin I levels, which are the most sensitive and effective according to the AHA/ACC guideline. The study\&#39;s secondary objective was to establish which parameters were associated with myocardial damage.

Primary Outcome Measures: high-sensitive Troponin I levels, preoperative|high-sensitive Troponin I levels, postoperative 24th hour|high-sensitive Troponin I levels, postoperative 48th hour
Comparison of Visual Instructions for Inserting a Laryngeal Mask in a Neonatal Mannequin.
NCT Number: NCT06502327
Acronym: Neo-LMi
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cardiopulmonary Resuscitation|Newborn Asphyxia
Interventions: OTHER: Instructions A|OTHER: Instructions B
Sponsor: National University of San Marcos, Peru
Sex: ALL
Age: ADULT
Enrollment: 55
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-07
Completion Date: 2025-03

Summary:
This research project compares the effectiveness of two visual instructions for inserting laryngeal masks. Researchers will assess the procedure performed by undergraduate health students on neonatal mannequins. The student's performance will be evaluated by assessing the results, timing and sequence recorded in videos during the simulation. An Ethical Committee reviewed and approved the protocol.

Primary Outcome Measures: Number of participants achieving effective ventilation., Effective ventilation with a manual resuscitator involves the inflow of air into the mannequin's lungs through the laryngeal mask and raising the thorax., Through study completion, an average of six months.
Secondary Outcome Measures: Timing measures in the procedure., The time, as recorded in a video, captures the entire process, including the required time to review instructions, the moment of laryngeal mask placement, the start of positive pressure ventilation, and the verification of the mannequin's chest expansion with ventilation., From the start of the review of instructions to the verification of chest expansion or failure to achieve chest expansion with at least three ventilation, whichever came first, assessed up to 10 minutes.|Number of participants achieving a correct sequence., The correct sequence, involves the initial use of a syringe to extract air, the placement of the laryngeal mask, and the final use of the syringe to inject air, before ventilation with a manual resuscitator., Through study completion, an average of six months.
A Comparative Study of Intrathecal Dexmedetomidine and Fentanyl as Additives to Bupivacaine in Pott's Fracture
NCT Number: NCT06502262
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Post Operative Pain
Interventions: DRUG: Bupivacaine Hydrochloride|DRUG: Fentanyl|DRUG: Dexmedetomidine
Sponsor: Ain Shams University
Sex: ALL
Age: ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-07-15
Completion Date: 2025-02-10

Summary:
The aim of this study is to compare the addition of intrathecal dexmedetomidine or fentanyl as adjuvants to hyperbaric bupivacaine in the onset and duration of sensory and motor block, and postoperative analgesia.

Primary Outcome Measures: motor blockade onset, Onset of motor block (defined as time in minutes from the end of drug injection intrathecally until patient is unable to move the hip, knee, and ankle), from injection up to 3 hours post operative|sesnory onset, defined as time in minutes to reach highest sensory level) will be tested every minute after intrathecal injection until it reach the highest level. It will be assessed by pin prick and cold application, from injection up to 3 hours post operative|post operative analgesia, will be evaluated using a visual analog scale (VAS),, from injection up to 3 hours post operative
Secondary Outcome Measures: drop in mean blood pressure, using non invasive arterial blood pressure monitoring, from injection up to 24 hours post operative|drop in oxygen saturation, using pulse oximiter, from injection up to24hours post operative|drop in heart rate, using ecg monitoring, from injection up to 24 hours post operative
Modulatory Effect of Prodigiosin or Pioglitazone on TIME and the Crosstalk to Immune-Checkpoint Protein(s)
NCT Number: NCT06502249
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Lung Cancer|NSCLC
Sponsor: Ain Shams University
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Observational Model: |Time Perspective: p
Start Date: 2026-06
Completion Date: 2028-09
Locations: Faculty of Pharmacy, Ain Shams University, Advanced Biochemistry Research Lab, Cairo, 11566, Egypt

Summary:
Lung cancer is one of the most common and serious types of cancer. Lung tumor cells exploit immune checkpoint proteins (ICPs) to maintain immune tolerance and thus promote tumor progression and invasion. Inhibition of ICPs using antibody therapies is one of the most common approaches for the treatment of lung cancer. Unfortunately, these antibody-based therapies can lead to severe adverse events. Moreover, a significant number of patients do not respond to immune checkpoint inhibition due to tumor heterogeneity and the immunosuppressive tumor immune microenvironment (TIME). The use of small molecule targeted approach instead of antagonizing antibodies may have the potential advantage of being able to target multiple ICPs in TIME with a single agent as well as improved tumor distribution.

Primary Outcome Measures: Gene Expression (mRNA levels), mRNA levels of HSP90, IL-6, STAT3,c-MYC and the novel immune checkpoint proteins by qRT-PCR from blood samples collected from NSCLC patients and cell pellets collected from lung cancer cell lines before and after pioglitazone or prodigiosin treatment, 36 months|Gene Expression (Protein levels), Protein levels of HSP90, IL-6, STAT3,c-MYC and the novel immune checkpoint proteins by immunoblotting from blood samples collected from NSCLC patients and cell pellets collected from lung cancer cell lines before and after pioglitazone or prodigiosin treatment, 36 months|cytotoxic effect, Cytotoxic effect of prodigiosin or pioglitazone on lung cancer cell line using MTT assay, 36 months|Anti-cancer efficiency of drug-loaded nanoparticles, Anticancer efficiency against lung cancer in vivo model using Urethan as lung cancer inducer or in vitro lung cancer cell line, 36 months
Identification of New Gene Spliceosomes in Neuroblastoma
NCT Number: NCT06502210
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Neuroblastoma
Interventions: PROCEDURE: Personalized surgical therapy of neuroblastoma
Sponsor: Affiliated Hospital of Nantong University
Sex: ALL
Age: CHILD
Enrollment: 20
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-04-01
Completion Date: 2024-08-31
Locations: Affiliated Hospital of Nantong University, Nantong, Jiangsu, China

Summary:
Neuroblastoma is an early childhood embryonic malignancy that originates from neural crest cells. Neuroblastoma shows high heterogeneity in biological, morphological, genetic, and clinical features. At present, the main treatment methods for neuroblastoma are surgical treatment combined with chemotherapy after the operation and immunological therapy. However， clinical studies have found that 40%～50% of patients don't have good outcomes after postoperative chemotherapy.

The clinical trial study aims to screen the genotype of children with neuroblastoma and conduct an in-depth analysis of sequencing data and tumor-specific transcripts by using technologies--Deep Sequencing Technology and Third Generation Sequencing Technology.

The main questions this study aims to answer are： \[Question 1\]This study will use Third Generation Sequencing technology to find specific transcript variants associated with cancer differentiation; \[Question 2\]This study will identify possible tissue differential expression by using the Deep Sequencing Technology.

Participants will undergo surgery, during which doctors will remove tumor tissue and adjacent normal tissue. In this experiment, the tumor tissue of children with neuroblastoma will be used as the experimental group, and the adjacent normal tissue will be used as the control group. In this study， the different genotypes of children with neuroblastoma are screened by Deep Sequencing Technology and Third Generation Sequencing Technology. And according to the difference in genotypes， doctors will treat children with neuroblastoma personally. This study hopes to find new single nucleotide polymorphism and therapeutic targets.

Primary Outcome Measures: The differential expression of tissue, The outcome measure is the change in tissue differential expression obtained by comparing the deep sequencing results of neuroblastoma tissue samples and normal tissue samples., 1 year|Specific transcript variant, The changes in tumor differentiation-related specific transcripts were found by comparing third-generation sequencing of neuroblastoma tissue sample cell lines., 1 year
Comparative Analysis of Silastic Stenting in Sinus Surgery
NCT Number: NCT06502197
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Chronic Rhinosinusitis (Diagnosis)
Interventions: PROCEDURE: Silastic Stenting
Sponsor: University of British Columbia
Collaborators: Addenbrooke's Hospital, Cambridge University|NHS Greater Glasgow and Clyde
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-02
Completion Date: 2026-03-02

Summary:
Silastic stenting is a measure taken to support tissue healing following sinus surgery. Silastic stents are inserted into the sinus cavities and provide structural support while facilitating healing in the critical period of recovery following surgery. There is controversy over the optimal duration for which silastic stents should be left in place. Having them in place for shorter periods may reduce the likelihood of stent-related reactions, while leaving them for longer periods could promote more tissue healing. The aim of this study is to compare the impact of stent duration on clinical outcomes of patients following sinus surgery.

Primary Outcome Measures: Long-Term Patency, Patency is to be assessed by using the validated scoring system from Lund VJ, Kennedy DW. Quantification for staging sinusitis. In: Kennedy DW, editor. International Conference on Sinus Disease: Terminology, Staging, Therapy. Ann Otol Rhinol Laryngol 1995; 104(Suppl 167):17-21., 6 and 18 months|Incidence of acute sinus infection, The occurrence and frequency of acute sinusitis in both cohorts, requiring rescue course of oral antibiotics., 2 and 4 weeks
Secondary Outcome Measures: Tolerability Assessment, Instrument: Likert Scale, At the respective stent extraction time|Symptom Relief Assessment, Instrument: Sinonasal Outcome Test-22 (SNOT-22), 6 and 18 months post-op
Iadademstat With Hypomethylating Agent in Patients With Myelodysplastic Syndrome
NCT Number: NCT06502145
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Myelodysplastic Syndromes
Interventions: DRUG: Azacitidine Level -1|DRUG: Azacitidine Level 0|DRUG: Azacitidine Level 1|DRUG: Iadademstat Level -1|DRUG: Iadademstat Level 0|DRUG: Iadademstat Level 1
Sponsor: Medical College of Wisconsin
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 9
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-10
Completion Date: 2027-10
Locations: Froedtert Hospital & the Medical College of Wisconsin, Milwaukee, Wisconsin, 53226, United States

Summary:
This is a phase I study with a primary objective of determining the recommended phase II dose of iadademstat with azacitidine in adult subjects with myelodysplastic syndrome (MDS).

Primary Outcome Measures: Recommended phase II dose of Iadademstat., The dose identified in this trial that will be used in future clinical trials., Up to two years
Knowledge, Attitudes, and Practices of Operative Vaginal Birth Among Obstetric Providers in Egypt
NCT Number: NCT06502119
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Birth Outcome, Adverse
Interventions: OTHER: Designed Questionnaire
Sponsor: Al-Azhar University
Sex: ALL
Age: ADULT
Enrollment: 5000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-20
Completion Date: 2024-12-30
Locations: Faculty od Medicine, Department of Obstetrics and Gynecology., Cairo, Cairo., Egypt

Summary:
The goal of this observational study is to evaluate the knowledge, attitudes, and practices of operative vaginal birth among obstetric providers in Egypt. The main questions it aims to answer are:

* What is the level of knowledge among obstetric providers regarding operative vaginal birth?
* What are the attitudes and practices of obstetric providers towards operative vaginal birth?

Participants will:

* Complete a detailed questionnaire assessing their knowledge, attitudes, and practices related to operative vaginal birth.
* Provide demographic information to contextualize their responses.

Primary Outcome Measures: Knowledge of Operative Vaginal Birth Among Obstetric Providers, The level of knowledge regarding operative vaginal birth among obstetric providers, assessed using a validated questionnaire. The knowledge score will be based on correct responses to a series of questions about indications, techniques, benefits, and risks associated with operative vaginal birth., Within 6 months of study commencement.|Attitudes Toward Operative Vaginal Birth Among Obstetric Providers, The attitudes of obstetric providers towards operative vaginal birth, measured using a Likert scale in the validated questionnaire. Providers will rate their agreement with statements related to their perceptions and opinions on the use of operative vaginal birth., Within 6 months of study commencement.|Practices of Operative Vaginal Birth Among Obstetric Providers, The frequency and context of operative vaginal birth practices among obstetric providers, as reported in the validated questionnaire. This measure will include the number of operative vaginal births performed, preferred techniques, and any barriers to performing these procedures., Within 6 months of study commencement.|Rate of Cesarean Sections Among Participants, The percentage of Cesarean sections performed by the obstetric providers participating in the study, as reported in the validated questionnaire. This measure aims to correlate knowledge, attitudes, and practices with the actual rate of Cesarean sections., Within 6 months of study commencement.
Efficacy of Serratus Posterior Intercostal Plane Block for Analgesia and Inflammatory Marker in Breast Surgery
NCT Number: NCT06502067
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Breastcancer|Perioperative Pain|Inflammation
Interventions: DRUG: Analgesia mangement group A,B
Sponsor: Ain Shams University
Sex: FEMALE
Age: ADULT
Enrollment: 80
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-25
Completion Date: 2025-07-01

Summary:
To study the efficiacy of serratus posterior superior block in controlling perioperative breast cancer surgery pain and its effect on inflamatory markers.

Primary Outcome Measures: is to calculate total perioperative analgesia consumption throughout (24hours)., 24 hour postoperative
MARPE Effect With/Without MOP in Non-growing Patients
NCT Number: NCT06502041
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Maxillary Transverse Deficiency
Interventions: PROCEDURE: MARPE with MOP|PROCEDURE: MARPE without MOP
Sponsor: Mansoura University
Sex: ALL
Age: ADULT
Enrollment: 24
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2022-09-05
Completion Date: 2024-07-03
Locations: Mansoura University, Mansoura, Adakhlia, Egypt

Summary:
This study compares the effect of MARPE (mini-implant assisted rapid palatal expansion) versus MARPE+ MOP (Micro-osteo-perforation) on nasal airway and maxillary transverse deficiency in non-growing patients.

Primary Outcome Measures: Number of days till diastema appearance, (days), about 1 month|Amount of skeletal expansion, (mm), about 1 month|Pain experience during activation of expander by visual analogue scale ( VAS), VAS: 0 ( no pain), 10 (unbearable pain), about 1 months|Skeletal, Dental & Nasal readings, from CBCT and scanned models measured in degrees \& mm, measured before treatment and after 6 month of treatment|Stability of correction of transverse deficiency, by measuring the same CBCT transverse reading and by superimposition of the scaneed models at the end of the research, about 6 months
Video Laryngeal Mask Versus Endotracheal Tube Undergoing Laparoscopic Cholecystectomy Surgery
NCT Number: NCT06502028
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cholecystitis
Interventions: DEVICE: Video laryngeal mask airway|DEVICE: Endotracheal tube
Sponsor: Seoul National University Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 102
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-26
Completion Date: 2026-05-26

Summary:
The aim of this study is to investigate the effectiveness of using a video laryngeal mask for airway management in patients undergoing laparoscopic cholecystectomy.

Primary Outcome Measures: Time required for VLMA insertion or intubation, After induction of anesthesia, before the operation starts.
Secondary Outcome Measures: Number of trials, Video laryngeal mask airway insertion or endotracheal intubation, After induction of anesthesia, before the operation starts.|Peak airway pressure, After video laryngeal mask airway insertion or intubation, before extubation|Minute ventilation, After video laryngeal mask airway insertion or intubation, before extubation|End tidal carbon dioxide, After video laryngeal mask airway insertion or intubation, before extubation|Oropharyngeal leak pressure, After video laryngeal mask airway insertion or intubation, before extubation|Traces of blood on airway device after extubation, After extubation, before transfer to PACU|Postoperative sore throat, 4-point scale, 0 = no sore throat; 1 = mild sore throat (complaints of sore throat only on asking); 2 = moderate sore throat (complaints of sore throat on his/her own); 3 = severe sore throat (change of voice or hoarseness, associated with throat pain), 1 hour after end of operation|Postoperative sore throat, 4-point scale, 0 = no sore throat; 1 = mild sore throat (complaints of sore throat only on asking); 2 = moderate sore throat (complaints of sore throat on his/her own); 3 = severe sore throat (change of voice or hoarseness, associated with throat pain), 24 hours after end of operation|Postoperative hoarseness, 4-point scale, 0 = no hoarseness; 1 = mild hoarseness (complaints of hoarseness only on asking); 2 = moderate hoarseness (complaints of hoarseness on his/her own); 3 = severe hoarseness (hoarseness associated with throat pain), 1 hour after end of operation|Postoperative hoarseness, 4-point scale, 0 = no hoarseness; 1 = mild hoarseness (complaints of hoarseness only on asking); 2 = moderate hoarseness (complaints of hoarseness on his/her own); 3 = severe hoarseness (hoarseness associated with throat pain), 24 hours after end of operation
Study of 5-fluorouracil (5-FU) in Patients With Metastatic Colorectal Cancer
NCT Number: NCT06501989
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Metastatic Colorectal Cancer
Interventions: DRUG: Biweekly 5-FLUOROURACIL (5-FU)|DRUG: Biweekly Modified FOLFOX6|DRUG: Biweekly FOLFIRI|DRUG: mFOLFOXIRI
Sponsor: Inova Health Care Services
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 10
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-30
Completion Date: 2025-02-25
Locations: Inova Health Care Service, Falls Church, Virginia, 22042, United States

Summary:
The purpose of this research is to see if adjusting the dose of 5-fluorouracil based on its concentration in your blood will improve the treatment of your metastatic colon cancer.

Primary Outcome Measures: Feasibility Of Pharmacokinetically (PK) Guided Does Adjustment of 5-Fluorouracil (5-FU) In a Community Oncology Setting, The Feasibility Of Pharmacokinetically Guided Does Adjustment of 5-Fluorouracil In a Community Oncology Setting is Defined as 80% Success Rate among Patients Who Has Completed Four Sequential PK blood Draws with Subsequent Dose Adjustments During the Treatment with 5-FU based Drug Therapy., From enrollment to the end of treatment at 8 weeks
An Exploratory Study of Lurbinectedin With Radiotherapy in Locally-advanced SCLC After First-line Therapy
NCT Number: NCT06501976
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Small Cell Lung Carcinoma
Interventions: DRUG: Lurbinectedin|RADIATION: Radiation Therapy
Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 9
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07
Completion Date: 2025-12

Summary:
This exploratory trial aims to determine if it is safe to use radiotherapy and lurbinectedin to treat locally-advanced SCLC after first-line therapy. This study will enroll patients with thoracic disease but no distant metastases after first line treatment failure. Lurbinectedin kills tumor cells by blocks transcription and damages the deoxyribonucleic acid (DNA) of tumor cells, which is similar to the way radiation kills tumor cells. Traditional chemotherapy and radiotherapy is a routine medical treatment for locally-advanced SCLC, but the combination is always toxic. This trial may help understand if treating patients with lurbinectedin and radiotherapy could cause less side effects.

Primary Outcome Measures: Incidence of adverse events of radio therapy with lurbinectedin, ≥grade 4 treatment related adverse events within 30 days of final RT fraction; Any treatment related adverse events leading to dose delays or reductions of lurbinectedin; Any treatment related serious adverse events ., 30 days following treatment completion
Secondary Outcome Measures: Progression free survival (PFS), PFS will be estimated using the Kaplan-Meier method, and a 95% confidence interval for median PFS will be estimated., From protocol treatment initiation to disease progression or death, assessed up to 24 months|Overall survival (OS), OS will be estimated using the Kaplan-Meier method, and a 95% confidence interval for median OS will be estimated., From treatment initiation to death, , assessed up to 24 months
Revealing Protective Immunity to Influenza Using Systems Immunology
NCT Number: NCT06501963
Acronym: PRISM
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Influenza
Interventions: BIOLOGICAL: Live Attenuated Influenza Vaccine
Sponsor: Emory University
Collaborators: Boston University
Sex: ALL
Age: ADULT
Enrollment: 50
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-09
Completion Date: 2027-02-28
Locations: Hope Clinic of the Emory Vaccine Center, Decatur, Georgia, 30030, United States

Summary:
The goals of this study are to better understand the human immune response to influenza vaccines, specifically the live attenuated (weakened) influenza vaccine given as a nasal spray. Better understanding why this vaccine does not work as well in adults as it does in children may help design better influenza vaccines.

Primary Outcome Measures: Quantification of Antibody Titers, The immunogenicity of the live attenuated influenza vaccine (LAIV) is evaluated by the quantification of antibody titers using hemagglutination inhibition (HAI) assays., Day 30
Secondary Outcome Measures: Mean geometric fold rise in HAI titers, The effect of LAIV on eliciting influenza-specific immune responses is analyzed as the mean geometric fold rise in HAI titers., Day 30|Frequency of Serious Adverse Events, The safety profile of LAIV is assessed as the frequency of serious adverse events occurring up to 30 days after vaccination., Up to Day 30
Clinical Study of Botanical Supplement Treatment for Hair Loss
NCT Number: NCT06501924
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Androgenetic Alopecia|Female Pattern Baldness|Male Pattern Baldness
Interventions: DIETARY_SUPPLEMENT: Daniel Alain Botanical Supplement Treatment for Hair Loss|DRUG: Topical minoxidil 5%
Sponsor: Applied Biology, Inc.
Collaborators: Follea International Limited|Daniel Alain, Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 516
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-16
Completion Date: 2025-09-12

Summary:
The primary objective of the study is to assess the efficacy of DA-001 as an oral supplement for treatment of hair loss (androgenetic alopecia).

Primary Outcome Measures: Target Area Hair Counts, Target Area Hair Counts, Week [0,24]