pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Bioequivalence Study of Rivaroxaban 20 mg Film-coated Tablets
NCT Number: NCT06558045
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Healthy
Interventions: DRUG: Rivaroxaban 20 mg film-coated tablet|DRUG: Xarelto 20 mg film-coated tablet
Sponsor: Dexa Medica Group
Sex: ALL
Age: ADULT
Enrollment: 26
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: OTHER
Start Date: 2023-07-06
Completion Date: 2023-10-02
Locations: PT Equilab International, Jakarta, 12430, Indonesia

Summary:
This study was an open-label, randomized, single-dose, two-period, two-sequence, two-way crossover study under fed conditions which included 28 healthy adult male and female subjects. The objective of this study was to compare whether the bioavailability of PT Dexa Medica's formulation of rivaroxaban 20 mg film-coated tablet is equivalent to that of the comparator drug (Xarelto® 20 mg Film-Coated Tablet, manufactured by Bayer AG, Germany, imported by PT Bayer Indonesia, Indonesia) when administered under fed condition in healthy subjects.

Primary Outcome Measures: AUC(0-t), Area under the plasma concentration-time curve to the last observer quantifiable concentration at time t, 36 hours|Cmax, Maximum plasma concentration, 36 hours
Secondary Outcome Measures: AUC(0-inf), Area under the plasma concentration-time curve extrapolated to infinitive time, 36 hours|T1/2, Plasma half-life, 36 hours|Tmax, Time taken to reach maximum observed plasma concentration, 36 hours
Bioequivalence Study of Tamsulosin 0.4 mg Sustained Release Film-coated Tablets
NCT Number: NCT06558032
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Healthy
Interventions: DRUG: Tamsulosin 0.4 mg Sustained Release Tablet (produced by PT Dexa Medica, Indonesia)|DRUG: Harnal® OCAS 0.4 mg Prolonged Release Tablet (produced by Astellas Pharma Europe B.V., The Netherlands, imported by PT Combiphar, Indonesia)
Sponsor: Dexa Medica Group
Sex: MALE
Age: ADULT
Enrollment: 28
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: OTHER
Start Date: 2023-11-06
Completion Date: 2024-02-07
Locations: PT Equilab International, Jakarta, 12430, Indonesia

Summary:
This study was an open-label, randomized, single-dose, four-period, two-sequence, fully replicate study under fasting conditions which included 28 healthy adult male subjects. The objective of this study was to find out whether the bioavailability of tamsulosin 0.4 mg sustained release film coated tablet produced by PT Dexa Medica is equivalent to that of the comparator drug (Harnal® OCAS 0.4 mg Prolonged Release Tablet produced by Astellas Pharma Europe B.V., The Netherlands, imported by PT Combiphar, Indonesia) when administered under fasting condition in healthy subjects.

Primary Outcome Measures: AUC(0-t), Area under the plasma concentration-time curve to the last observer quantifiable concentration at time t, 72 hours|Cmax, Maximum plasma concentration, 72 hours
Secondary Outcome Measures: AUC(0-inf), Area under the plasma concentration-time curve extrapolated to infinitive time, 72 hours|T1/2, Plasma half-life, 72 hours|Tmax, Time taken to reach maximum observed plasma concentration, 72 hours
Exosome-based OCS Scores for Predicting Ovarian Cancer Recurrence
NCT Number: NCT06558019
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Ovarian Cancer
Sponsor: Lei Li
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 509
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-10-01
Completion Date: 2026-12-31
Locations: Peking Union Medical College Hospital, Beijing, Beijing, China

Summary:
Ovarian cancer is the third most common malignant tumor in China's female reproductive system in terms of incidence rate and the first in terms of mortality. Surgery and systemic chemotherapy are the cornerstone of first-line treatment for patients with epithelial ovarian cancer. The efficacy rate of first-line platinum combined with taxus chemotherapy is more than 80%, and more than half of them reach complete remission (CR). However, even if advanced patients reach CR, 50% -70% still relapse, with a median disease-free interval of 16 months. Most patients lack typical symptoms when they relapse. The sensitivity of CA125 in monitoring recurrence is poor (43-74%), which means that more than 25% of ovarian cancer patients cannot detect recurrence in a timely manner during follow-up. Therefore, more sensitive biomarkers are needed for monitoring ovarian cancer recurrence after treatment. More and more studies have explored the application value of extracellular vesicle technology in the diagnosis and treatment of ovarian cancer, including auxiliary diagnosis, prognosis, monitoring, etc. China already has an approved exosome ovarian cancer diagnostic product by the National Medical Products Administration, namely the Ovarian Cancer Diagnostic Score (OCS) product based on exosome technology, which is also the world's first exosome technology diagnostic kit for ovarian cancer. Clinical trial data shows that OCS products have demonstrated excellent performance in distinguishing between benign and malignant ovarian tumors. Under high specificity (90.2%), it has a higher sensitivity than serum CA125, reaching 95.5% (95% CI 92.7% -97.3%), and has a sensitivity of 89.7% in the diagnosis of stage I ovarian cancer. OCS exhibits better sensitivity than CA125, especially in early ovarian cancer, suggesting that OCS may be a better tool for monitoring recurrence in ovarian cancer patients.The main purpose of this study is to establish an OCS scoring ovarian cancer recurrence prediction and monitoring model based on exosome technology, providing an effective tool for clinical ovarian cancer recurrence prediction and monitoring. Secondly, we hope to explore the correlation between OCS score and tumor staging, chemotherapy sensitivity, PFS, OS indicators, etc., and determine the performance of recurrence prediction models in different subgroups, such as different pathological subtypes of ovarian cancer and different treatment methods.

Primary Outcome Measures: progression-free survival, Progression-free survival after diagnosis, 2 yeas|overall survival, Overall survival after diagnosis, 2 years
Safety and Efficacy Predimenol for Headache
NCT Number: NCT06558006
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Headache
Interventions: DRUG: Predimenol tablet|DRUG: Predimenol tablet + Placebo tablet of Predimenol|DRUG: Placebo tablet of Predimenol
Sponsor: Dexa Medica Group
Collaborators: Fakultas Kedokteran Universitas Indonesia
Sex: ALL
Age: ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-06-19
Completion Date: 2024-12
Locations: Imeri Fkui, Jakarta Pusat, DKI Jakarta, 10430, Indonesia|Klinik Satelit Makara UI Depok, Depok, Jawa Barat, Indonesia

Summary:
This is a prospective, double-blind, placebo-controlled and randomized study aimed to obtain a description of the efficacy and safety of Predimenol in alleviating headache.

Primary Outcome Measures: Visual Analogue Scale (VAS), VAS (Visual Analogue Scale) for headache (0 - 100), with 0 indicates asymptomatic and 100 refers to the most serious or severe symptom.

VAS will be measured at baseline and 10 min, 20 min, 30 min, 1 hour, 2 hour after drug administration., Time 0, 10 min, 20 min, 30 min, 1 hour, 2 hour|Adverse events, Any kind of adverse events (AE) and serious adverse events (SAE) will be observed throughout the study conduct., Time 0, 10 min, 20 min, 30 min, 1 hour, 2 hour
Effectiveness of Serratus Posterior Superior Intercostal Plane Block Applied With Ultrasonography in Myofascial Pain Syndrome
NCT Number: NCT06557993
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Pain, Neck
Interventions: OTHER: Serratus Posterior Superior Intercostal Plane Block
Sponsor: Halil Ibrahim Altun
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-06-01
Completion Date: 2024-10-01
Locations: Kanuni Sultan Süleyman Training and Research Hospital, Istanbul, 34000, Turkey

Summary:
Trigger point treatment in myofascial pain syndrome should be planned according to its etiology to prevent relapses. Although there are various modalities, in cases where medical and noninvasive methods are ineffective, diluted local anesthetic injections or diluted local anesthetic injections with steroids, and sometimes dry needling or botulinum toxin, are preferred. In recent years, imaging methods such as ultrasonography have been frequently used for trigger point injections. These injections may be repeated for several sessions depending on the patient's response. Pain, local anesthetic toxicity, bleeding, allergic reactions, pneumothorax, intramuscular hematoma, cerebrovascular events, spinal injury, vasovagal syncope and infections have been reported during injections. Therefore, during trigger point injections, vascular access should be established in the patient, the patient should be monitored, injections should be performed under sterile conditions, and an emergency kit should be kept ready in all cases .

The serratus posterior superior muscle is located deep to the rhomboid major and minor. Ligamentum nuchae starts from the processus spinosus of C7-T3 vertebrae and extends to the 2nd-5th. In the ribs, the angulus ends at the upper edge of the rib. Serratus posterior superior -intercostal plane block (SPSİPB) is a newly defined block, and C7-T7 spread has been shown in cadaver studies . In our study, investigators compared the newly defined SPSİPB, which is practical to be applied with USG in Myofascial Pain Syndrome (MAS), which is frequently seen especially in young people and desk workers, with trigger point injection, which has been used in the treatment of MAS for many years and whose effectiveness has been proven, and SPSİPB applied from a single point with USG guidance. investigators aimed to contribute to the literature regarding the effectiveness of in MAS. The newly defined rhomboid intercostal plane block and SPSIPB are routinely applied successfully in our algology clinic in patients with MAS and postzoster neuralgia in the thoracic region.

Primary Outcome Measures: onset of pain and application time of intervention Visual Analog Scale (VAS), four months
Effectiveness of Calcium Silicate and Sodium Fluoride Nanoparticles in The Management of Dentin Hypersensitivity
NCT Number: NCT06557980
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Dentin Hypersensitivity
Interventions: OTHER: toothpaste
Sponsor: Minia University
Sex: ALL
Age: ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2025-10

Summary:
This study will be performed to assess the effect of inert prepared tooth paste loaded with Calcium Silicate Nanoparticles (CSNPs) and compare it to another one containing Sodium Fluoride Nanoparticles in the management of patients complaining of hypersensitivity and laboratory investigating the efficacy of CSNPs and NaFl Nps containing toothpaste in dentinal tubules occlusion.

Primary Outcome Measures: The Visual analogue scale, The Visual analogue scale on a scale (0 = no pain,10 = extreme pain)., one year|The Verbal rating scale, The Verbal rating scale from to: (0 = no discomfort, 1=mild discomfort,2 = significant discomfort,3= significant discomfort lasting more than 10 seconds), one year
Study on Prevalence and Impact of Brain Metastases on Survival in Lung Cancer by Line of Treatment
NCT Number: NCT06557967
Status: ACTIVE_NOT_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Non-small Cell Lung Cancer|Lung Cancer|Metastatic Cancer|Brain and Central Nervous System Cancer
Interventions: OTHER: No drug
Sponsor: Daiichi Sankyo
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 22517
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-03-01
Completion Date: 2024-09-30
Locations: ConcertAI Database, Cambridge, Massachusetts, 02138, United States

Summary:
This study will use real-world data to assess prevalence of brain metastases in metastatic non-small cell lung cancer (mNSCLC) patients and its impact on associated clinical outcomes.

Primary Outcome Measures: Overall Survival (OS) of (AGA+/-) mNSCLC Participant With And Without Brain Metastases by Line of Therapy, From baseline to end of follow-up or death, whichever comes first, up to approximately 40 months.
Cervical Cytology DNA Methylation for Cervical Cancer Screening
NCT Number: NCT06557954
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Cervical Cancer|DNA Methylation|Cytology|Human Papillomavirus Infection|Cervical Intraepithelial Neoplasia|Cancer Screening
Interventions: DIAGNOSTIC_TEST: human PAX1 and JAM3 gene methylation assays (PAX1m/JAM3m)
Sponsor: Lei Li
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 30000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-01
Completion Date: 2026-10-01
Locations: Peking Union Medical College Hospital, Beijing, Beijing, China

Summary:
Cervical cancer represents one of the foremost causes of cancer-related morbidity and mortality among women worldwide. Given the current limitations, such as the low specificity of human papillomavirus (HPV) testing and the relatively low sensitivity of cytological examinations, there is a pressing need for a novel, non-invasive, safe, and precise screening method. This study aims to undertake a multicentre, real-world investigation, incorporating at least 10 sub-centres and enrolling 30,000 participants. Histopathological examination results will serve as the 'gold standard' for evaluating the screening efficacy of human PAX1 and JAM3 gene methylation assays (PAX1m/JAM3m), HPV testing, and cytological examinations. Furthermore, the study seeks to elucidate the relationship between DNA methylation levels and persistent HPV infection, while also assessing the applicability of PAX1m/JAM3m across diverse clinical settings. By focusing on alterations in DNA methylation levels within cervical exfoliated cells as the primary research trajectory, this study aspires to furnish novel insights and theoretical foundations for the prevention and management of cervical cancer, targeting PAX1m/JAM3m. The ultimate objective is to facilitate the clinical implementation of an enhanced cervical cancer screening protocol, thereby addressing the deficiencies of current screening methodologies, achieving greater precision in cervical cancer screening, and effectively reducing the incidence of cervical cancer while mitigating the risks of overdiagnosis and overtreatment.

Primary Outcome Measures: Number of participants with histopathological diagnosis of grade 2 cervical intraepithelial neoplasia (CIN) or worse (CIN2+), Including CIN2, CIN3, adenocarcinoma in situ and invasive cervical carcinoma, 1 year|Number of participants with histopathological diagnosis of grade 3 cervical intraepithelial neoplasia (CIN) or worse (CIN3+), Including CIN3, adenocarcinoma in situ and invasive cervical carcinoma, 1 year
Secondary Outcome Measures: Number of participants with histopathological diagnosis of invasive cervical carcinoma, Including invasive cervical carcinoma of various subtypes, 1 year
Risk Factors of Extubation Failure in PICU Patients
NCT Number: NCT06557941
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Extubation Failure
Sponsor: Sohag University
Sex: ALL
Age: CHILD, ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-05-01
Completion Date: 2025-05
Locations: Sohag University Hospitals, Sohag, Egypt

Summary:
Up to 20% of MV patients experience EF \[10\]. EF is defined as the need to reinsert the endotracheal tube to resume MV in patients extubated for less than 48 hours. It has high rates of morbidity and mortality, prolongs the duration of MV and thus causes a longer stay in the PICU and risk of complications such as the need for tracheostomy, the incidence of pneumonia and pulmonary damage, and finally, costs increase as well and death \[10, 11\] .

Primary Outcome Measures: successful extubation and weaning from mechanical ventilation, passing spontaneous trial and air leak test and not requiring to be re-intubated within 2 days, 48 hours|failed extubation , failed weaning from mechanical ventilation, not passing spontaneous trial and air leak test and not requiring to be re-intubated within 2 days, 48 hours
Secondary Outcome Measures: survival or death, weaning from mechanical ventilation and improvement of the cause of intubation, 30 days
Protocol for Evaluating Physiological and Psychological Adaptation Mechanisms in Tibetan Plateau Environments
NCT Number: NCT06557928
Status: ENROLLING_BY_INVITATION
Study Type: OBSERVATIONAL
Conditions: High Altitude
Interventions: OTHER: measurement
Sponsor: Peking Union Medical College Hospital
Sex: ALL
Age: ADULT
Enrollment: 17
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-05-17
Completion Date: 2027-12-01
Locations: Peking Union Medical College Hospital, Beijing, China

Summary:
This study is a single-center prospective observational study. It plans to use a series of physiological and medical instruments and international common physiological and psychological questionnaires. To dynamically detect the changes of physiological and psychological adaptability of doctors in Peking Union Medical College Hospital before leaving Beijing, 1-7 days after arriving at the plateau in Tibet during the acute phase of plateau hypoxic stress, 2 weeks, 3 months, 6 months, 12 months after staying in Tibet during the chronic phase of plateau hypoxic stress, and after returning to Beijing.

Primary Outcome Measures: help understand the physiological mechanisms and psychological changes of hypoxic adaptation, This study is expected to increase our understanding of the physiological mechanisms and psychological changes of hypoxic adaptation mainly through analysis of multi-omics., 2024-5-27~2026-12-1
Nasal Problems in Neonates and Infants Subjected to CPAP
NCT Number: NCT06557915
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Continuous Positive Airway Pressure
Interventions: PROCEDURE: screening
Sponsor: Sohag University
Sex: ALL
Age: CHILD
Enrollment: 30
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-10
Completion Date: 2025-12
Locations: Faculty of Medicine, Sohag University, Sohag, 82511, Egypt

Summary:
The goal of this study is to Detect and Screen different nasal complications of using CPAP in neonates and infants and reach a consensus about minimizing nasal problems of CPAP in neonates and infants

Primary Outcome Measures: Detection of different nasal complications of using CPAP in neonates and infants, the metric used is complete ENT examination of neonates and infants subjected to CPAP, 1 week following using CPAP in neonates and infants
Safety, Tolerability and Pharmacokinetics of Lumateperone in Pediatric Patients With Autism Spectrum Disorder
NCT Number: NCT06557902
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Autism Spectrum Disorder
Interventions: DRUG: Lumateperone 10.5 mg capsule|DRUG: Lumateperone 21 mg capsule|DRUG: Lumateperone 5 mg ODT|DRUG: Lumateperone 10.5 mg ODT|DRUG: Lumateperone 15.5 mg ODT|DRUG: Lumateperone 21 mg ODT
Sponsor: Intra-Cellular Therapies, Inc.
Sex: ALL
Age: CHILD
Enrollment: 26
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-05-10
Completion Date: 2026-07-31
Locations: Clinical Site 6, Miami, Florida, 33133, United States|Clinical Site 7, Orlando, Florida, 32803, United States|Clinical Site 1, Atlanta, Georgia, 30331, United States|Clinical Site 2, Decatur, Georgia, 30030, United States|Clinical Site 3, Savannah, Georgia, 31405, United States|Clinical Site 4, Saint Charles, Missouri, 63304, United States|Clinical Site 5, Lincoln, Nebraska, 68526, United States|Clinical Site 8, Everett, Washington, 98201, United States

Summary:
Study ITI-007-035 is a Phase 1b, multicenter, open-label study to evaluate the safety, tolerability, and PK of lumateperone for pediatric patients with Autism Spectrum Disorder.

Primary Outcome Measures: Pharmacokinetics: Cmax, Maximum plasma concentration of lumateperone, Day 5|Pharmacokinetics: Tmax, Time of maximum plasma concentration of lumateperone, Day 5|Pharmacokinetics: AUC0-tau, Area under the plasma lumateperone concentration time curve from time zero to the end of dosing (tau), Day 5
Secondary Outcome Measures: Percentage of patients with treatment-emergent adverse events, Up to 30 days after last dose|Change from baseline in systolic and diastolic blood presssure, Day 6|Change from baseline in ECG QT interval, Day 6|Change from baseline in hemoglobin, Day 6|Change from baseline in white blood cell count, Day 6|Change from baseline in aspartate aminotransferase, Day 6|Change from baseline in alanine aminotransferase, Day 6|Change from baseline in Abnormal Involuntary Movement Scale (AIMS), AIMS is a measure of facial and oral movements, extremity movements and trunk movements. Items are rated on a scale from none (0) to severe (4)., Day 6
A Trial Investigating Lu AG22515 in Adult Participants With Moderate-to-Severe Thyroid Eye Disease
NCT Number: NCT06557850
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Thyroid Eye Disease
Interventions: DRUG: Lu AG22515
Sponsor: H. Lundbeck A/S
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 19
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-26
Completion Date: 2026-09-15

Summary:
This trial will evaluate the effects of Lu AG22515 in adult men and women with moderate-to-severe thyroid eye disease (TED). TED is an autoimmune condition closely related to Graves' Disease.

In people with TED, the healthy tissue behind and around the eye becomes inflamed and swollen. One of the key symptoms of TED is proptosis (bulging eyes). The main goal of this trial is to learn whether treatment with Lu AG22515 improves proptosis in participants with moderate-to-severe TED.

Primary Outcome Measures: Change in Proptosis from Baseline to Week 24 in the Trial Eye Using the Hertel Exophthalmometer, Baseline, Week 24
Secondary Outcome Measures: Cmax: Maximum Observed Serum Concentration of Lu AG22515, Predose up to Week 52|Tmax: Time to Maximum Observed Cmax of Lu AG22515, Predose up to Week 52|Ctrough: Minimum Observed Serum Concentration of Lu AG22515, Predose up to Week 52|AUC0-infinity: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity of Lu AG22515, Predose up to Week 52|t½: Apparent Elimination Half-life of Lu AG22515, Predose up to Week 52|CL: Apparent Total Serum Clearance of Lu AG22515, Predose up to Week 52|Volume of Distribution of Lu AG22515, Predose up to Week 52|Number of Participants with Anti-drug Antibodies, Up to Week 52
Pulmonary Rehabilitation Combined With Speleotherapy in Children With Bronchial Asthma
NCT Number: NCT06557824
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Asthma in Children
Interventions: OTHER: speleotherapeutic intervention
Sponsor: University School of Physical Education, Krakow, Poland
Collaborators: Andrzej Frycz Modrzewski Krakow University|Sanatorium Edel|Health Resort "Wieliczka" Salt Mine
Sex: ALL
Age: CHILD, ADULT
Enrollment: 415
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-01-07
Completion Date: 2023-10-11
Locations: University of Physical Education in Krakow, Krakow, 31-571, Poland

Summary:
The goal of this retrospective study is to learn about the effects of rehabilitation and treatment stays combined with speleotherapy in children with asthma. Medical records of 415 patients with this clinical diagnosis were analyzed and the main question was:

• Does speleotherapeutic intervention increase distance in 6-Minute Walk Test (6MWT) and influence spirometry parameters and fractional exhaled nitric oxide concentration (FeNO) in children with asthma?

Primary Outcome Measures: Forced expiratory flow in 1 second, Forced expiratory flow in 1 second, pp=percent predicted (FEV1 \[pp\]) to assess the pulmonary function in children with asthma before and after speleotherapeutic intervention., January 2022 and October 2023|6-Minute Walk Test (6MWT), 6-Minute Walk Test (6MWT) distance was measured to assess exercise tolerance in children with asthma before and after speleotherapeutic intervention., January 2022 and October 2023|Peak expiratory flow (PEFR [pp]), Peak expiratory flow (PEFR \[pp\]) to assess the pulmonary function in children with asthma before and after speleotherapeutic intervention., January 2022 and October 2023
Secondary Outcome Measures: Fractional exhaled nitric oxide concentration (FeNO), The fractional exhaled nitric oxide concentration (FeNO) was measured to recognize the presence of eosinophillic inflammation involving the bronchial tree in children with asthma before and after speleotherapeutic intervention., January 2022 and October 2023
A Phase 2a/b Study of the Efficacy and Safety of Subcutaneous Amlitelimab in Adults With Nonresponsive Celiac Disease
NCT Number: NCT06557772
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Coeliac Disease
Interventions: DRUG: Amlitelimab|DRUG: Placebo|DIETARY_SUPPLEMENT: SIGE|DIETARY_SUPPLEMENT: Gluten-free product (GFP)
Sponsor: Sanofi
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 204
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-16
Completion Date: 2029-04-10

Summary:
This is a Phase 2a/b, randomized, double-blind, placebo-controlled, parallel-group, 6-arm study to evaluate the efficacy and safety of amlitelimab in adult participants with non-responsive celiac disease (NRCD) who are on a gluten free diet (GFD) with and without simulated inadvertent gluten exposure (SIGE).

The primary purpose of this study is to demonstrate the efficacy of subcutaneous (SC) amlitelimab in male and female participants (aged 18 to 75 years, inclusive) with NRCD. The study will assess the effect of amlitelimab when compared to placebo to improve or attenuate gluten induced changes in the intestinal mucosa as measured by the villous height to crypt depth (Vh:Cd) ratio. The effect of amlitelimab on participant-reported celiac signs and symptoms along with the safety, tolerability, and pharmacokinetics of amlitelimab will also be studied.

Study details include:

The study duration will be up to 48 weeks for participants not entering the long-term extension study (including a 16-week safety follow-up period).

The study duration will be up to 32 weeks for participants who enter the long-term extension study.

The treatment duration will be up to 28 weeks. The number of visits will be up to 10 visits.

Primary Outcome Measures: Change in Villus Height to Crypt Depth Ratio (Vh:Cd) from baseline to Week 28, Change in Vh:Cd ratio., Baseline to Week 28
Secondary Outcome Measures: Change in Celiac Disease Symptom Diary (CDSD) Gastrointestinal (GI) symptom severity score, The CDSD is a patient report outcome instrument that assesses common celiac symptoms (abdominal pain, bloating, tiredness, nausea, and diarrhea). GI symptom severity score ranges from 0-20 with higher score indicating more severe disease., Baseline to Week 28|Percentage of participants who experienced treatment-emergent adverse events (TEAEs), including serious adverse events (SAEs) and adverse events of special interest (AESI), Baseline to Week 44|Percentage of participants with potentially clinically significant abnormalities (PCSA) for vital signs and clinical laboratory assessments, Baseline to Week 44|Percentage of participants discontinued from study treatment due to TEAEs, Baseline to Week 44|Serum amlitelimab concentrations measured at prespecified timepoints, Baseline to Week 28|Incidence of antidrug antibodies (ADAs) of amlitelimab, Baseline to Week 44
30-Minutes of Listening to Relaxing Music on Attendees of a Workshop Session at a Local Conference
NCT Number: NCT06557759
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Depression|Anxiety|Autonomic Dysregulation
Interventions: BEHAVIORAL: Listening to Relaxing Music
Sponsor: University of Florida
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-10-08
Completion Date: 2025-04-01
Locations: The Walt Disney World Dolphin Resort, Lake Buena Vista, Florida, 32830, United States

Summary:
The goal of this clinical trial is to explore possible benefits and mechanisms through which listening to music can improve health and wellness. The main goals of the study are:

* To investigate whether pre-survey measures of autonomic reactivity relate to the overall functioning of participants.
* To examine the immediate effects of listening to the music.
* To identify individual characteristics that influence the immediate effects of listening to the music.

Participants will:

* complete the online pre-assessment measures assessing their adversity history, psychiatric symptomatology, autonomic reactivity, embodiment, and perceived social connection.
* Listen to the brief music demo
* Listen to the full 30-minute music session.
* Complete the online post-assessment measures assessing psychiatric symptomatology, autonomic reactivity, embodiment, and perceived social connection.

Primary Outcome Measures: Measuring Change in Autonomic Reactivity using the Body Perceptions Inventory Short Form, This 20-item measure is scored on a 5-point Likert scale (never = 1, occasionally = 2, sometimes = 3, usually = 4, always = 5). Items are summed to determine total autonomic reactivity score, with the higher scores indicating greater autonomic reactivity, From baseline through study completion, an average of 1 day|Measuring Change in Body Sensations using the Neuroception of Psychological Safety Scale, Th 8-item Body Sensations subscale is scored on a 5-point Likert scale (Strongly Disagree = 1, disagree = 2, neither agree or disagree = 3, agree = 4, strongly agree = 5). Items are summed together to create a total subscore, with higher scores reflecting internal sensations of the body ina state of calm capturing the feeling of relaxation in the face and the body, steady heartbeat and breath, and settled stomach., From baseline through study completion, an average of 1 day|Assessing the Impact of Adversity History on the Effectiveness of Listening to Music, This measure assesses the impact of six types of traumatic experiences (childhood adverse experiences, childhood maltreatment, intimate partner maltreatment, other person maltreatment, life-threatening situations, sudden losses, and person health situations). Each item is scored on a 5-point Likert scale (did not occur = 0, occurred and no impact on my life = 1 to big impact on my life = 4). Items are summed to determine total impact scores., Baseline
Coca-Cola vs. Oxygen for Fatigue Management in Tibet Surgeons
NCT Number: NCT06557746
Acronym: COMETS
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Fatigue
Interventions: OTHER: Coca-Cola|OTHER: Supplemental oxygen
Sponsor: Peking Union Medical College Hospital
Collaborators: Tibet Autonomous Region People's Hospital
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 22
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-09-01
Completion Date: 2025-04-01

Summary:
The study will be conducted among surgeons in Tibet, comparing the effects of Coca-Cola and supplemental oxygen on fatigue alleviation. Additionally, pre-planned subgroup analyses will examine the potential differences in effectiveness between Tibetan surgeons who have long lived in high-altitude areas and Han surgeons who work in these areas for shorter periods. The investigators hypothesize that for Tibetan surgeons, Coca-Cola will be more effective in alleviating fatigue, while for Han Chinese surgeons, supplemental oxygen will be more effective.

Primary Outcome Measures: Attention decrease, Attention decrease is measured in terms of the difference in the concentration performance score (CP). The participants will take the d2 Test of Attention before and after every scheduled operation and get two CP scores (preoperative and postoperative). The higher the score, the better the attention. Therefore, a smaller difference (ΔCP) between preoperative and postoperative scores indicates a better effect in relieving fatigue., 30 minutes before the surgery; end of the surgery; (the duration depends on the surgery complexity, at least 2 hours)
Secondary Outcome Measures: Maximal voluntary contraction force decrease, Maximal voluntary contraction force (MVC) is measured by hand dynamometer. The participants will be tested before and after every scheduled operation and get two MVC (preoperative and postoperative). The greater the strength, the less fatigued the hand muscles are. Therefore, a smaller difference (ΔMVC) between preoperative and postoperative scores indicates a better effect in relieving fatigue., 30 minutes before the surgery; end of the surgery; (the duration depends on the surgery complexity, at least 2 hours)
Exploring the Characteristics of Epileptogenic Foci in Drug-Resistant Epilepsy Based on Multimodal Imaging Technology
NCT Number: NCT06557720
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Drug Resistant Epilepsy|Magnetic Resonance Imaging|Electroencephalogram (EEG)
Sponsor: Xijing Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-11
Completion Date: 2025-06-01
Locations: Xijing Hospital of Air Force Military Medical University, Xi'an, China

Summary:
Using multimodal imaging technology, this study aims to explore the characteristics of epileptogenic foci in patients with drug-resistant epilepsy and identify key network nodes (such as central nodes) to provide more assistance for the diagnosis of drug-resistant epilepsy.

Primary Outcome Measures: The characteristics of hybrid imaging in patients with different types of refractory epilepsy., Based on PET-FMRI-EEG hybrid fusion technology, explore the brain network characteristics of epilepsy patients.PET detects areas of reduced glucose metabolism, using radioactive isotopes (such as 18F-labeled fluorodeoxyglucose) to reflect the glucose metabolism of brain tissue. Typically in epilepsy patients, areas of hypometabolism may indicate the presence of epileptic foci. By using fMRI or EEG data, the synchronization of activities between different brain regions is analyzed to understand the organization and functional connectivity patterns of the brain network., baseline|The characteristics of PET, fMRI, and EEG indicators in patients with different types of intractable epilepsy., Using different data analysis methods to explore the characteristics of PET, fMRI, and EEG indicators in patients with various types of intractable epilepsy.The characteristics of the power spectrum of various EEG frequency bands (Delta, Theta, Alpha, Beta, Gamma waves) and brain functional connectivity., baseline
Secondary Outcome Measures: Quality of Life in Epilepsy 31 (QOLIE-31), It assesses various aspects of a patient's life that can be affected by their condition, including physical, emotional, and social well-being., baseline，4weeks
Cardiovascular Health & Early Stress
NCT Number: NCT06557707
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Stress
Interventions: OTHER: Childhood stress
Sponsor: Virginia Commonwealth University
Sex: ALL
Age: CHILD, ADULT
Enrollment: 120
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-01-20
Completion Date: 2028-12
Locations: Virginia Commonwealth University, Richmond, Virginia, 23298, United States

Summary:
Childhood adversity is highly prevalent, with 59% of the U.S. population reporting at least one adverse childhood experience (ACE). Substantial evidence links childhood adversity to cardiometabolic disease later in the life course, including heart disease, diabetes, and stroke, which are 3 of the top 10 causes of mortality in the United States.

ACEs encompass many possible traumatic and distressing experiences, including abuse, neglect, or severe household dysfunctions. It is not surprising that the experience of those extreme events during the first decade of life has tremendous implications for the individual's psychological and physical health.

Primary Outcome Measures: Vascular function, This test examines how the blood vessels respond to different challenges and expand. It is used to characterize the cardiovascular health of the subject's blood vessels. Different events and substances will be used (under an IND) to test how the blood vessels react. The test is completed using Laser Doppler Speckle Contrast. We will measure how much the blood vessels dilate. Greater dilation, better vascular function., Baseline|Cardiac Function, An evaluation of cardiac response will be monitored non-invasively. We will use ultrasound to visualize the heart and the blood vessels., Baseline|Cardiac MRI (CMR), Cardiac MRI will be completed to monitor early signs of poor functionality., Baseline
Secondary Outcome Measures: Spirometry, Subjects will undergo a lung function test to measure how well their lungs work. The volume of air moving in and out of the lungs will be assessed. FEV1 will be evaluated. FEV1 is the amount of air a person can exhale in the first second after inhaling as deeply as possible., Baseline|Lung Diffusing Capacity, Subjects will undergo a lung function test to measure how well their air is diffused from their lungs. DLCO will be evaluated. DLCO stands for diffusing capacity of the lungs for carbon monoxide, and it's a pulmonary function test that measures how well oxygen moves from the lungs into the bloodstream., Baseline|Complete blood count, Blood analysis, Baseline|HbA1c, Blood analysis, Baseline|C-Reactive protein, Blood analysis, Baseline|Questionnaires, Lifestyle and stress related questionnaires will be completed by the participants including lifestyle, adversity during childhood, stress risk., Baseline|Arterial Stiffness, A non-invasive assessment will be used to measure how fast the participant's blood travels, which is a measure of how stiff their arteries are., Baseline
Effect of COVID-19 Infection on Obstertric Complications and Maternal Outcomes
NCT Number: NCT06557694
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: COVID-19|Infection|Obstetric Complication|Maternal Outcomes
Interventions: OTHER: Data collection
Sponsor: Tanta University
Sex: FEMALE
Age: ADULT
Enrollment: 260
Study Design: Observational Model: |Time Perspective: p
Start Date: 2021-01-01
Completion Date: 2022-12-01
Locations: Tanta University, Tanta, El-Gharbia, 31527, Egypt

Summary:
This study aimed to evaluate the effect of COVID-19 infection on obstetric complications and maternal outcomes.

Primary Outcome Measures: Pregnancy related complications, Pregnancy related complications as preterm birth, preeclampsia, intrauterine fetal demise (IUFD), increased cesarean section rate, postpartum hemorrhagic gastroenteritis (HGE) were collected, For one month
Secondary Outcome Measures: Intensive care unit admission rate, Intensive care unit admission rate was collected., For one month|Use of mechanical ventilation, Use of mechanical ventilation was collected., For one year|Incidence of death, Incidence of death was collected., For one month|Apgar score, Apgar score is a quick test performed on a baby at 1 and 5 minutes after birth. The Apgar score is based on a total score of 1 to 10. The higher the score, the better the baby is doing after birth. A score of 7, 8, or 9 is normal and is a sign that the newborn is in good health., For 5 minutes post-intervention
The Effect of Virtual Reality Treadmill-Based Gait Training on Gait and Balance Ability in Chronic Stroke Patients
NCT Number: NCT06557681
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Stroke|Hemiplegia
Interventions: DEVICE: Virtual Reality-Treadmill Training Group (VTT)|OTHER: Conventional Therapy Group (CT)
Sponsor: Yonsei University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-03-25
Completion Date: 2024-09-27
Locations: Department and Research Institute of Rehabilitation Medicine, Yonsei University College of Medicine, Seoul, Korea, Republic of

Summary:
Walking independence is one of the most important goals for stroke patients and a major factor influencing their return to society after the onset of stroke. Stroke patients experience walking difficulties due to hemiplegia and have an increased risk of falls due to impaired balance ability. Recent studies have shown that treadmill-based walking training incorporating virtual reality can help improve walking and balance functions in actual stroke patients. However, there are few randomized clinical trials with control groups, highlighting the need for further research to ensure the reliability of clinical effects.

Therefore, this study aims to investigate the impact of treadmill-based training incorporating virtual reality on walking and balance functions. The training equipment to be used is the C-mill VR+ device, which enables walking training and assessment, balance training and assessment, and obstacle training using a front screen and treadmill videos. The investigators intend to thoroughly examine the walking ability and balance ability of the subjects obtained through this equipment, along with various evaluation tools.

Primary Outcome Measures: Time Up and Go (TUG), The Timed Up and Go (TUG) test is a simple and reliable assessment used to evaluate a patient's mobility and balance abilities. During the test, the patient starts seated in a chair, then stands up, walks 3 meters to a designated marker, turns around, walks back to the chair, and sits down. The time taken to complete this sequence is measured. Shorter completion times indicate better mobility and balance. The TUG test is widely used to assess walking ability and fall risk in various conditions, including stroke and geriatric disorders., Pret-intervention Assessment|Time Up and Go (TUG), The Timed Up and Go (TUG) test is a simple and reliable assessment used to evaluate a patient's mobility and balance abilities. During the test, the patient starts seated in a chair, then stands up, walks 3 meters to a designated marker, turns around, walks back to the chair, and sits down. The time taken to complete this sequence is measured. Shorter completion times indicate better mobility and balance. The TUG test is widely used to assess walking ability and fall risk in various conditions, including stroke and geriatric disorders., Baseline (Pre-intervention) and immediately after intervention completion (6 weeks after intervention start)
Clinical Outcomes of Treatment With Immunomodulator Plus Cancer Therapies for Patients With Colorectal Cancer
NCT Number: NCT06557668
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Colorectal Cancer
Sponsor: Taichung Veterans General Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 150
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-20
Completion Date: 2025-04
Locations: Chung-Shan Medical University Hospital, Taichung City, Taiwan|Taichung Veterans General Hospital, Taichung City, Taiwan

Summary:
This study aims to evaluate the survival and treatment outcomes among colorectal cancer patients undergoing anti-cancer treatment, both with and without an immunomodulator.

Primary Outcome Measures: Overall survival, From the initial treatment until April 2024
Secondary Outcome Measures: Progress free survival, From the initial treatment until April 2024|Tumor response, From the initial treatment until April 2024
Caffeinate Chewing Gum on Ice Hockey Performance
NCT Number: NCT06557655
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Caffeine|Placebo
Interventions: DIETARY_SUPPLEMENT: caffeinate chewing gum
Sponsor: National Taiwan Sport University
Sex: MALE
Age: ADULT
Enrollment: 14
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: SINGLE (INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-02-05
Completion Date: 2024-04-30
Locations: National Taiwan University of Sport, Taichung, 404, Taiwan

Summary:
The purpose of this study was to examine the impact of caffeinated chewing gum on the physical performance of elite ice hockey players in a partial sleep deprivation state.

Primary Outcome Measures: counter-movement jump, jump height, 15 minutes after intervention
Secondary Outcome Measures: 35-metre sprint, complete time (seconds), 15 minutes after intervention
Nitrous Oxide and EMOtional Cognition
NCT Number: NCT06557642
Acronym: NEMO
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Depression
Interventions: DRUG: Entonox|DRUG: Medical Air
Sponsor: University of Oxford
Sex: ALL
Age: ADULT
Enrollment: 84
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-10
Completion Date: 2025-10-01
Locations: Psychiatry Department, Oxford, OX3 7JX, United Kingdom

Summary:
The goal of this study is to uncover the underlying neuropsychological mechanisms of nitrous oxide, which may be relevant to its reported antidepressant effects. In particular, the study is designed to determine whether nitrous oxide changes the way in which healthy volunteers aged 18-40 years remember negative autobiographical memories.

The main question the study aims to answer is:

• Does nitrous oxide interfere with the emotional aspects of negative autobiographical memories?

Other neuropsychological effects will also be assessed (e.g., emotional processing, emotional memory, response inhibition, and cognitive flexibility).

Researchers will compare ENTONOX (50% nitrous oxide: 50% oxygen) with medical air.

Participants will:

* Attend three research visits (screening, inhalation, follow-up)
* Take part in a 30 minute inhalation session of ENTONOX or medical air
* Complete a series of cognitive tasks
* Finish a series of self-report questionnaires

Primary Outcome Measures: Changes in Emotional Ratings of Personal Memories (Memory Reconsolidation), Negative/positive valence ratings associated with personal memories. A series of positive and negative adjectives will be presented to participants and they will have to rate on a scale of 1(not at all) to 10 (extremely) to what extent these words apply to how they feel when recalling the memory., 2 days before and 1 day after treatment
Secondary Outcome Measures: Performance on Emotional Processing Tasks, Performance on the Emotional Testing Battery (ETB), which contains an emotional word categorisation task, an emotional facial recognition task, and two emotional memory tasks., Immediately before and after treatment and 1 day after treatment|Performance on Cognitive Flexibility Task, Performance on a probabilistic reversal learning task in which participants have to learn which strategy on a computer-task leads to a reward., 1 day after treatment|Performance on Response Inhibition Task, Performance on an emotional go/no-go task in which participants have to inhibit their responses to certain stimuli based on rules given at the start of each block of the task., 1 day after treatment