pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Differential Effects of in Vivo and Virtual Exposure Therapy in Agoraphobia
NCT Number: NCT06514495
Acronym: VRExpo
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Agoraphobia; Panic|Social Anxiety Disorder
Interventions: OTHER: Therapy
Sponsor: Johannes Gutenberg University Mainz
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 68
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2027-08-01

Summary:
Anxiety disorders, including agoraphobia, are prevalent in the German population, leading affected individuals to avoid specific places like crowds or public transport. Although cognitive-behavioral therapy with exposure is an effective treatment, many patients resort to medication rather than therapy. Virtual Reality Exposure Therapy (VRET) shows promise in easing exposure treatment with customizable scenarios. Interoception (body symptom perception) and the endocannabinoid system are explored as factors in maintaining agoraphobia. Studies investigate how therapies like exposure (both in vivo and in VR) impact these factors and treatment outcomes. Interoception, especially in panic disorder patients, plays a crucial role, with accurate heartbeat perception linked to maintaining anxiety. The endocannabinoid system, affecting various functions, is studied for its role in therapy outcomes and its modulation of the body's stress response. The study aims to understand how these systems interact in agoraphobic patients and how therapy affects their functionality.

Primary Outcome Measures: Extent of Interoceptive Attention, Interoceptive attention assessed via a questionnaires (interoceptive attention/ IA). Higher scores reflect a higher interoceptive attention., through study completion, an average of 2 years|Extent of Interoceptive Accuracy, Interoceptive accuracy assessed via a questionnaire (interoception accuracy scale/IAS). Higher scores reflect a more accurate/sensitive interoception., through study completion, an average of 2 years|Extent of Objective Interoceptive Sensitivity, Interoceptive sensitivity assessed via heart rate measures., through study completion, an average of 2 years|Concentration of Bioparameters under rest and under acute stress, Blood measures of cortisol, immune parameters (IL-6, IL-10), endocannabinoids will be assessed under rest and under acute stress during a Trier Social Stress Test. Unit of measure for all biomarkers is pg/ml., through study completion, an average of 2 years
Spanish Registry of Patients With Sleep Apnea and Daytime Sleepiness
NCT Number: NCT06514482
Acronym: HYPNOSA
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Sleep Apnea
Interventions: DIAGNOSTIC_TEST: Diagnosis
Sponsor: Hospital San Pedro de Logroño
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-10-28
Completion Date: 2025-10-28
Locations: Hospital San Pedro, Logroño, La Rioja, 26006, Spain

Summary:
Multicenter, observational and prospective study, in which patients referred to the sleep unit with suspected apnea will be recruited obstructive sleep. 1000 patients referred to the sleep unit will be recruited with suspected obstructive sleep apnea. The recruited patients will undergo a sleep study for the diagnosis of OSA, ambulatory monitoring of blood pressure (ABP) of 24 hours, clinical variables will be obtained, questionnaires of quality of life, Epworth test for the evaluation of daytime sleepiness, variables biochemistry and obtaining biological samples. OSA patients will be managed following the usual practice. In those patients for whom the treatment with CPAP an evaluation of adherence to treatment will be carried out.

OSA patients will be evaluated at baseline, 6, 12, and 24 months.

Primary Outcome Measures: Primary Outcome, Data analysis of the AHI in the respiratory polygraphy, 6 months
Barriers and Faciliators for Physical Activity in People With RMDs
NCT Number: NCT06514443
Acronym: COPA
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Osteoarthritis, Knee|Osteoarthritis, Hip|Rheumatoid Arthritis|Axial Spondyloarthritis
Interventions: OTHER: survey
Sponsor: Anne-Kathrin Rausch
Collaborators: Acibadem University|Leiden University Medical Center|Sorbonne University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 400
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-01
Completion Date: 2025-03-31

Summary:
The aim of this project is to systematically survey and explore barriers and facilitators for the implementation of physical activity according to the physical activity recommendations of the European Alliance of Associations for Rheumatology on country specific (e.g., environmental, cultural, organization and system) level. A questionnaire to explore/identify these barriers and facilitators in the survey, will be developed through literature search, interviews with multiple stakeholders (i.e., patients with inflammatory arthritis or osteoarthritis and physical therapists) and experts in the field in four different European countries (i.e., Turkey, Switzerland, the Netherlands and France).

Additionally, in Switzerland only, the Inflammatory Arthritis Facilitators and Barriers to Physical Activity (IFAB) Questionnaire which was developed to determine the factors on personal level, will be translated into the German language. Aim is to evaluate the validity and reliability of the IFAB Questionnaire in the German-speaking population with axial Spondyloarthrits, and to perform a cultural adaptation if necessary at the same time.

Primary Outcome Measures: barriers and facilitators for physical activity, factors on social, envirionmental or system level impacting the physial activity behaviour, September-December 2024
Secondary Outcome Measures: reliability of the IFAB, ONLY Swiss participants with axSpA, September-December 2024|validity of the IFAB, ONLY Swiss participants with axSpA, September-December 2024
External Oblique Intercostal Plane Block for Patients Undergoing Upper Abdominal Surgeries
NCT Number: NCT06514417
Acronym: EOINB
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Post Operative Pain
Interventions: OTHER: US-guided external oblique intercostal block
Sponsor: Menoufia University
Collaborators: Ayman Ahmed Rady|Ahmed Mohamed Helwa
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 25
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: OTHER
Start Date: 2023-07-10
Completion Date: 2024-06-10
Locations: Menoufia university, Cairo, Shibin Elkom, Egypt

Summary:
Ithe study will evaluate the analgesic efficacy of external oblique intercostal block for patients undergoing upper abdominal surgeries

Primary Outcome Measures: Visual analogue pain scale ., postoperative pain that evaluated by visual analogue pain scale(a scale from 0 to 10 where 0 is interpreted as no pain, 1-4 mild pain, 5-6 moderate pain, 7-10 severe pain), 24 hours
Secondary Outcome Measures: total perioperative analgesics requirements, Milligram, 24 hours
Comparative Study of Empathy and Anxiety in the Different Academic Years, at the Beginning of Academic Year and Exam Period in Healthy Students.
NCT Number: NCT06514404
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Health Education|Health Promotion|Health Behavior
Interventions: OTHER: observational study
Sponsor: Mayuben Private Clinic
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 65
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-01
Completion Date: 2024-09-10

Summary:
Students from different health science degrees will carry out a study on the variables of empathy, anxiety and personality profile.

Primary Outcome Measures: Empathy Quotent, It consists of 60 items, 40 measuring empathy and 20 control measures. Scores range from 0 to 80. It measures cognitive and affective empathy in adults. Equalizer allows classification into four categories, which facilitates comparison between groups. The cut-off for each level is: from 0 to 32 scores: low empathy (average scores in Asperger Syndrome is 20), from 33 to 52 scores: average empathy (average in men 42, average in women 47), from 53 to 63 scores: above average, from 64 to 80 scores: high empathy, Through study completion, an average of 1 week|State anxiety, The response scale is Likert-type with 4 alternatives (in the Spanish adaptation from 0 to 3). There are 20 items for evaluation. Thus, the range of responses goes from 0 to 60, with a higher level of anxiety corresponding to a higher score., Through study completion, an average of 1 week|Anxiety as a trait, The response scale is Likert-type with 4 alternatives (in the Spanish adaptation from 0 to 3). Trait anxiety has 20 items for its evaluation. Thus, the range of responses goes from 0 to 60, with a higher level of anxiety corresponding to a higher score., Through study completion, an average of 1 week|Abbreviated personality questionnaire, The EPQR-A is an abbreviated form of the Eysenck Personality Questionnaire. It is a 24-item self-report measure that leverages three personality scales (extraversion, neuroticism and psychoticism) and a lie validity scale. Each scale is assessed by 6 questions that participants rate on a binary frequency scale scored 1 or 0., Through study completion, an average of 1 week
Immediate Loading of Four Single Piece Compressive Implants for Bar Retained Mandibular Overdenture
NCT Number: NCT06514391
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Compressive Implants
Interventions: PROCEDURE: compressive single piece dental implant
Sponsor: Mansoura University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 15
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-02-15
Completion Date: 2024-06-13
Locations: Mansoura University, Faculty of dentistry, Mansoura, Egypt

Summary:
this study was done to evaluate clinically and radiographically four single piece inter-foraminal compressive implant connected via digitally designed co-cr milled bar with distal cantilever supporting mandibular overdenture. The evaluation will be done clinically and radiographically as following:

* Marginal bone loss
* Soft tissue changes around the implants

Primary Outcome Measures: Peri-implant marginal bone loss, Peri-implant marginal bone loss was evaluated for each implant by the aid of cone beam CT scan, at time of insertion of prosthesis T(0), 6 months after insertion T(6), 12 months after insertion T(12)
Secondary Outcome Measures: Peri-implant soft tissue health, probing depth was measured for each implant by the aid of plastic probe, at time of insertion of prosthesis T(0), 6 months after insertion T(6), 12 months after insertion T(12)
Safety of Endobronchial Mesenchymal Stromal Cells in the Treatment of Chronic Lung Allograft Dysfunction
NCT Number: NCT06514378
Acronym: ENDOSCLAD
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Chronic Lung Disease|Lung Transplant Rejection
Interventions: BIOLOGICAL: Mesenchymal stem cells
Sponsor: Instituto De Investigación Sanitaria Puerta De Hierro-Segovia De Arana
Collaborators: Ministerio de Ciencia, Innovación y Universidades
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 12
Study Design: Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-09-19
Completion Date: 2026-03-31
Locations: Hospital Universitario Puerta de Hierro Majadahonda, Madrid, Spain

Summary:
Lung transplantation is the only therapeutic alternative for more and more patients with respiratory diseases in their most advanced stages.

The most limiting factor to achieve long term survival si chronic lung allograft dysfunction, a multifactorial disease without an effective treatment.

The immunomodulatory capacity of mesenchymal stem cells enables them to be a potential therapeutic agent for this condition.

The objective of this study is to assess the safety of endobronchial administration of allogeneic MSCs in patients with chroniclung allograft dysfunction.

Primary Outcome Measures: Early onset adverse events, Incidence of early onset (24h) adverse events following MSCs administration: desaturation, hypotension, radiological infiltrates, fever or changes in oxygen therapy requirements., 24 hours|Adverse events, Incidence of adverse events of special interest since randomization: lower respiratory tract infections, acute rejection (as defined by the presence of A1-A4 o B1R, B2R in biopsy), BO worsening (as measured by \>10% decline in FEV1 from baseline)., One year since randomization
Clinical Trial of VIM With VIT in Children With Relapsed and Refractory Soft Tissue Sarcoma.
NCT Number: NCT06514313
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Soft Tissue Sarcoma
Interventions: DRUG: Mitoxantrone Hydrochloride Liposome+Irinotecan+Vincristine|DRUG: Temozolomide+Irinotecan+Vincristine
Sponsor: Yizhuo Zhang
Sex: ALL
Age: CHILD, ADULT
Enrollment: 110
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-03
Completion Date: 2026-12-01
Locations: Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, 510060, China

Summary:
Explore the efficacy and safety of mitoxantrone liposome combined with irinotecan and vincristine (VIM) in the treatment of relapsed/refractory soft tissue sarcoma in children.

Primary Outcome Measures: Objective response rate (ORR), Objective response rate (ORR) after 2 cycles of chemotherapy with VIM or VIT regimen, including complete response (CR) and partial response (PR), Up to 2 cycles of chemotherapy (each cycle is 21 days)
Secondary Outcome Measures: Objective response rate (ORR), Objective response rate (ORR) after 4 cycles of chemotherapy with VIM or VIT regimen, including complete response (CR) and partial response (PR), Up to 4 cycles of chemotherapy (each cycle is 21 days)|Disease control rate (DCR), Refers to the percentage of patients with confirmed complete response, partial response, and disease stability in patients with evaluable efficacy, Up to 4 cycles of chemotherapy (each cycle is 21 days)|Progression-free survival (PFS), Means from the date of enrollment to the date of first disease progression or death from any cause, whichever comes first. If the subject has no disease progression during the trial period, PFS is defined as the last date until the subject's last confirmed progression-free survival., From date of radomization unit the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 moths.|Overall survival (OS), Overall survival (OS) was defined from the date of enrollment to the date of death from any cause., From date of radomization unit the date of first documented date of death from any cause, assessed up to 24 moths
Other Outcome Measures: Circulating tumor DNA (ctDNA) ., ctDNA was dynamically monitored and the correlation between ctDNA and efficacy was evaluated., Assessed up to 24 moths.
Investigating Myosteatosis in Steatotic Liver Diseases
NCT Number: NCT06514300
Acronym: MYO-SLD
Status: ENROLLING_BY_INVITATION
Study Type: OBSERVATIONAL
Conditions: Alcohol-related Liver Disease|Metabolic Dysfunction Associated Steatotic Liver Disease|Steatotic Liver Disease of Mixed Origin (MetALD)|Steatotic Liver Diseases|Myosteatosis|Magnetic Resonance Imaging|Magnetic Resonance Spectroscopy|Liver Histology
Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Collaborators: Fonds National de la Recherche Scientifique|Concerted Research Action
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2020-06-22
Completion Date: 2024-08
Locations: Cliniques universitaires Saint-Luc, Brussels, 1200, Belgium

Summary:
Steatotic liver diseases (SLD) are the most common chronic liver diseases worldwide. SLD are defined by an excessive liver lipid content (steatosis) of more than 5% of the total liver weight and includes 3 clinical entities : metabolic dysfunction-associated steatotic liver disease (MASLD), alcohol-related liver disease (ALD) and a mixed entity combining the two settings referred as MetALD. SLD are associated to extra-hepatic complications such as cardiovascular diseases, insulin resistance or muscle changes. Among the latter, myosteatosis, defined by an excessive muscle fat content, has been reported as a muscle change in MASLD occuring even in non-cirrhotic stages. Investigators will explore these muscle changes in SLD patients according to the severity of the underneath liver disease.

Primary Outcome Measures: correlation between muscle mass and fat content and liver histological features of SLD, muscle mass and fat content will be assessed by magnetic resonance imaging and spectroscopy. Liver phenotype will be histologically assessed by 3 blinded pathologists and computer-assisted morphometry., MRI and liver biopsy are performed at Day 1
Secondary Outcome Measures: liver molecular mechanisms involved in myosteatosis pathogenesis, mRNA extraction and sequencing from liver tissue samples collected during liver biopsy to assess the transcriptomic pattern correlating with muscle fat assessed by MRI., liver samples are collected during the biopsy|impact of muscle fat content on muscle function, investigators assess the correlation between muscle fat assessed by MRI and muscle function assessed by several tests., muscle function tests are performed 1-week after the biopsy/MRI (Day 7)
Study on The Efficacy and Safety of Vonoprazan-containing Berberine Triple Therapy in Helicobacter Pylori First-Line Eradication
NCT Number: NCT06514274
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Helicobacter Pylori Infection|Chronic Gastritis
Interventions: DRUG: Berberine|DRUG: Vonoprazan|DRUG: Amoxicillin|DRUG: Bismuth|DRUG: Clarithromycin|DRUG: Esomeprazole
Sponsor: Xijing Hospital of Digestive Diseases
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 558
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-10
Completion Date: 2025-10
Locations: Xijing Hosipital of Digestive Disease, Xi'an, Shaanxi, 710032, China

Summary:
The purpose of this study was to evaluate the efficacy and safety of the triple therapy of berberine hydrochloride, vonorasan and amoxicillin for the primary eradication of Helicobacter pylori.It is hypothesized that berberine hydrochloride, amoxicillin and vonoprazan triple therapy is non-inferior to bismuth-containing quadruple therapy.Patients diagnosed with H. pylori infection will be randomly divided into one of the above treatments. At week 6 follow-up visits, a urea breath test，rapid urease test or helicobacter pylori stool antigen test will be performed to confirm eradication.

Primary Outcome Measures: H pylori eradication rates, The primary end point of this study is H.pylori eradication,established by negative urea breath test，rapid urease test or helicobacter pylori stool antigen test 28 days after the end of treatment., 28 days after treatment
Secondary Outcome Measures: symptoms effective rate, Evaluation effective rate of symptoms 2 weeks of treatment and 4 weeks after the end of treatment.

Symptom effective rate =（total score before treatment - total score after treatment）/total score before treatment x 100%.

Total score = frequency + severity.

Frequency score is calculated by all the frequency of heartburn, reflux, abdominal pain, and flatulence.

Severity is accumulated by the degree of symptoms described above, which is divided to 4 degree as 0 presenting none, and 3 presenting most severe, 14 days of treatment, and 28 days after treatment|adverse events, Participants with Adverse Events as a Measure of Safety and Tolerability.The common side effects of the study include headache, dizziness, skin rash, other gastrointestinal disorders, pyrexia, cough and back pain., 14 days of treatment, and 28 days after treatment
Clinical Evaluation of the V5-LU01 AI Software in Thoracic CT for V5med Inc.
NCT Number: NCT06514248
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Lung Cancer
Interventions: DEVICE: V5med Lung AI
Sponsor: V5med Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 16
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: DIAGNOSTIC
Start Date: 2023-12-18
Completion Date: 2024-05-17
Locations: Arlington Innovation Center: Health Research, Arlington, Virginia, 22203, United States

Summary:
STUDY DESIGN:

This is a two-arm retrospective, multi-reader, multi-case, (MRMC) randomized reader study.

OBJECTIVE:

Primary: The primary objective of this clinical study is to prove that radiologist's performance aided with V5med Lung AI is superior to the unaided for detecting qualified lung nodules.

Secondary: The secondary objective of this clinical study is to prove that the radiologist's reading time is not significantly increased when aided with V5med Lung AI.

Addition Objectives: To prove that the agreement (e.g., in kappa correlation coefficient) between experts and radiologist's Lung-RADS score aided with V5med Lung AI is superior to the unaided.

NUMBER OF SUBJECTS:

Retrospective CT studies from approximately 350 patients will be included in the study with approximately 170 true positive cases and 180 normal cases.

PRIMARY ENDPOINTS:

Scores given by the radiologists with and without V5med Lung AI will be recorded and compared to the true status of the study-cases. The frequency of the scores for each method (Aided, Unaided) will be tabulated and LROC curves constructed along with sensitivity, specificity, PPV, NPV and clinical actions. Additionally, machine nodule detection rate and false positives per patient on normal cases will be measured.

PATIENT POPULATION:

The study will target approximately two hundred (200) patients whose CT lung nodules were shown to be cancer and one hundred and eighty (150) patients who have no lung nodule greater than 4mm. The patient population will be consistent with the national lung cancer screening protocols.

Primary Outcome Measures: Comparing the Detection Accuracy, Sensitivity, and Specificity of Clinically Actionable Lung Nodules, The detection rates in accuracy, sensitivity, and specificity on clinically actionable lung nodules were computed and compared for Aim 1 (baseline) and Arm 2 (study participants were aided with V5med Lung AI) studies., 6 months|Comparing LROC Curve in the Detection of Clinically Actionable Lung Nodules Among Normal, The areas under location-specific Receiver Operating Characteristic (LROC) curves were computed and compared for Aim 1 (baseline) and Aim 2 (study participants were aided with V5med Lung AI)., 6 months
Secondary Outcome Measures: Average Reading Time Per Case, The average reading times per reader per case were computed and comapred in both Aim 1 and Arm 2 (study participants were aided with ClearRead CT software) studies., 4 months
Image-guided Brachytherapy for Vaginal Cancer (EMBRAVE)
NCT Number: NCT06514235
Acronym: EMBRAVE
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Vaginal Neoplasms
Interventions: OTHER: Observational study (Non-interventional study)
Sponsor: Erasmus Medical Center
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 300
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-11-28
Completion Date: 2033-11-30
Locations: Erasmus MC, Rotterdam, Zuid-Holland, 3015 CD, Netherlands

Summary:
The goal of this clinical study is to improve clinical outcomes of patients with vaginal cancer who are treated with curative intent by primary radio(chemo)therapy and image-guided adaptive brachytherapy (IGABT).

Being an observational, prospective registration study, wherein neither an experimental treatment is compared to the standard treatment, nor groups of patients are compared.

The specific aims are:

* to develop evidence-based recommendations for curative intent treatment with primary radio(chemo)therapy and IGABT.
* to identify prognostic parameters for oncological outcomes, morbidity and quality of life.

The study aims to enroll at least 300 patients. Oncological events will be evaluated at 2 and 5 years of follow-up. Acute and late morbidity events will be evaluated at end of treatment, 2 and 5 years of follow-up.

Primary Outcome Measures: Local failure, A new, recurrent or progressive residual tumor within the external beam low-risk clinical target volume (CTV-TLR)., 2 and 5 years of follow-up|Late physician-assessed morbidity and patient reported outcomes, Physician-assessed (CTCAE v.5) and Patient Reported Outcome (EORTC C30, selected items of CX24, EN24 and VU34)., 2 and 5 years of follow-up|Acute physician-assessed morbidity and patient reported outcomes, Physician-assessed (CTCAE v.5) and Patient Reported Outcome (EORTC C30, selected items of CX24, EN24 and VU34)., End of Treatment
Secondary Outcome Measures: Other oncological outcomes, Regional failure, distant metastasis, disease free survival, disease-specific survival, overall survival., 2 and 5 years of follow-up
Pain Control Following Third Molar Surgery
NCT Number: NCT06514222
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: EARLY_PHASE1
Conditions: Post Operative Pain|Impacted Third Molar Tooth
Interventions: DRUG: Paracetamol and Ibuprofen. The combination of the Paracetamol and Ibuprofen will be given together every 8 hours|DRUG: Paracetamol and Ibuprofen. The combination of the Paracetamol and Ibuprofen will be given alternatively every four hours
Sponsor: University of Sharjah
Sex: ALL
Age: ADULT
Enrollment: 56
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-01
Completion Date: 2024-09-30
Locations: University dental Hospital, Sharjah, United Arab Emirates

Summary:
In this study, the investigators recruited patients undergoing surgical removal of impacted third molar teeth. Participants will be randomly divided into two groups Group 1: The patient will receive 400mg of ibuprofen plus 1000mg of Paracetamol simultaneously every 8 hours for two days.

Group 2- The patient will receive 400mg ibuprofen and 1000mg Paracetamol at 4 hours in intervals for two days. With a total of 3 doses of ibuprofen and 3 doses of paracetamol per day Then, pain control will be assessed using various primary and secondary outcome scales.

Primary Outcome Measures: Visual Analogue Scale, Pain was analyzed in 2 ways:

(1) as the mean of pain intensity VAS score evaluated at 0, 4, 8, 12, 24, 36, and 48 hours post-extraction. Range 0-10, 48 hours|The maximum pain experienced by patients, a)No pain, b)Some pain, c)Noticeable pain and d)Extreme pain, 48 hours
Secondary Outcome Measures: Onset of pain control, The time to analgesic onset is defined as the time between trial drug intake and the first report of pain relief,, 48 hours|Duration of pain control, the time between the first report of perceptible and meaningful pain relief and pain reappearing,, 48 hours|the rescue medicine intake, the time from trial drug intake to the intake of the first dose of the rescue medicine, 48 hours
Effect of Different Depths of Neuromuscular Blockade on Respiratory Mechanics in Patients With Moderate-severe Acute Respiratory Distress Syndrome
NCT Number: NCT06514209
Acronym: ARDS
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: ARDS|Lung Protective Ventilation
Interventions: DRUG: cisatracurium
Sponsor: Southeast University, China
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-28
Completion Date: 2025-06-30
Locations: Zhongda Hospital, Affiliated to Southeast University, Nanjing, Jiangsu, China

Summary:
Acute respiratory distress syndrome (ARDS) is characterized by acute diffuse alveolar injury caused by a variety of pulmonary and extrapulmonary factors, leading to refractory hypoxemia. It has high incidence and mortality rates. Neuromuscular blocking agents (NMBAs) play a crucial role as adjunctive therapy for ARDS, aiding in lung-protective ventilation by inhibiting excessive spontaneous breathing, improving patient-ventilator synchrony, and reducing barotrauma.

Determining the appropriate depth of muscle relaxation in moderate to severe ARDS patients receiving NMBAs remains a clinical challenge. Research has shown that partial neuromuscular blockade is feasible in certain ARDS patients. However, large randomized controlled trials (RCTs) and clinical practices often use higher doses of NMBAs to ensure complete cessation of spontaneous breathing. This indicates an ongoing debate regarding the optimal depth of neuromuscular blockade necessary for lung-protective ventilation in ARDS patients. It also raises the question of whether the optimal depth of neuromuscular blockade varies among patients with different severities of ARDS.

This study aims to investigate changes in respiratory mechanics and other physiological parameters in moderate to severe ARDS patients under different depths of neuromuscular blockade. The investigators will evaluate the impact of targeted neuromuscular blockade depth on lung protection in these patients.

Primary Outcome Measures: transpulmonary pressure (PL), At baseline and 15 minutes after each adjustment of the cisatracurium dose.
Secondary Outcome Measures: esophageal pressure swing（∆Pes）, At baseline and 15 minutes after each adjustment of the cisatracurium dose.|train train of four count (TOF-count), At baseline and 15 minutes after each adjustment of the cisatracurium dose.
Post- Approval Hintermann Series H® Study 1
NCT Number: NCT06514196
Status: ACTIVE_NOT_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Ankle Osteoarthritis|Post-Traumatic Osteoarthritis of Ankle|Osteoarthritis of Ankle Secondary to Inflammatory Arthritis (Disorder)
Interventions: DEVICE: Hintermann Series H3 Total Ankle Replacement System
Sponsor: DT MedTech, LLC
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 298
Study Design: Observational Model: |Time Perspective: p
Start Date: 2020-06-18
Completion Date: 2025-01-20
Locations: Kantonsspital Baselland, Bruderholz, CH-4101, Switzerland

Summary:
The H3 TAR device received U.S. Food and Drug Administration (FDA) Premarket Approval (PMA) on June 4, 2019, and as a condition of that approval, this study is being conducted to provide long-term safety and effectiveness of the H3 TAR System among patients included in the Primary Safety and Effectiveness (PSE) Cohort (P1600361).

This will be a Prospective, single-center, single arm study.

Primary Outcome Measures: AOFAS Score Measurement, The American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Score is among will be used for measuring the outcome of treatment in patients who sustained a complex ankle or hindfoot injury. It will be measured at a minimum 10 years post-operation, 10 Years|Survivorship Measurement, Survivorship (absence of removal/revisions to include polyethylene revision) will be recorded at 10 years from surgery, 10 Years|Serious device-related adverse event Measurement, Percentage of subjects with a serious device-related adverse event, other than a revision or removal will be calculated at 10 years from surgery, 10 Years|Reoperation, revisions or removals Measurement, Safety Reporting of the reoperation, revisions or removals of the Hintermann Ankle device will be reviewed and analyzed, 10 Years|Serious Device-Related Adverse Events Measurement, Incidence, occurrence, and types of serious device-related adverse events will be reviewed and analyzed for subjects Nature, onset, duration, severity, relationship to the device, and relationship to the operative procedure and outcome of any adverse event will be measured., 10 Years|Device Explant Analysis Measurement, Any explanted devices / device components will be returned and handled for analysis as described in Attachment G: Explant and Revision Protocol, to be examined for wear and damage., Through Study Completion an Average of 10 years
Eumycetoma Long-term Post-Treatment Follow-Up Study
NCT Number: NCT06514183
Status: TERMINATED
Study Type: OBSERVATIONAL
Conditions: Eumycetoma
Interventions: OTHER: Clinical diagnosis of recurrence
Sponsor: Drugs for Neglected Diseases
Collaborators: Soba University Hospital
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 51
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-01-26
Completion Date: 2023-06-26
Locations: Mycetoma Research Center, Soba University Hospital, Khartoum, Sudan

Summary:
To assess the long-term recurrence rate of eumycetoma in clinical trial participants treated in the phase II DNDi-FOSR-04-MYC clinical trial.

Primary Outcome Measures: To assess recurrence of eumycetoma lesions up to 5 years after end of treatment in participants previously treated with fosravuconazole 200 mg or 300 mg weekly or itraconazole 400 mg daily in study DNDi-FOSR-04-MYC, Population: Participants in trial DNDi-FOSR-04-MYC who had no recurrence of eumycetoma lesion before month 15

* Treatment: fosravuconazole 200 mg or 300 mg weekly or itraconazole 400 mg daily in study DNDi-FOSR-04-MYC
* Variable: Time to recurrence of eumycetoma lesion (if lesion occurred) or time followed-up without lesion, 6 years
Secondary Outcome Measures: To determine efficacy of fosravuconazole 200 mg or 300 mg monotherapy vs. itraconazole monotherapy, after long term post-treatment follow-up, Population/Treatment/Variable/Intercurrent events: as for primary estimand Hazard ratios comparing a) risk of recurrence for fosravuconazole 200mg vs. itraconazole, 15 months|To assess overall recurrence of eumycetoma lesions up to 5 years in participants treated with fosravuconazole 200 mg or 300 mg weekly or itraconazole 400 mg daily in study DNDi-FOSR-04-MYC, Population: Participants in trial DNDi-FOSR-04-MYC regardless of recurrence before Month 15.

Treatment/Variable/Intercurrent events: as defined for the primary estimand, 6 years|To describe the etiologic pathogen (subtype of fungus) after long term recurrence, Population: Participants with recurrence of eumycetoma within the current study Summary measure: Proportion of recurrences of each subtype

* Treatment: as for primary estimand
* Variable: Typing of fungus, 15 months
Gastrointestinal Dysfunction in Aortic Surgery Patients
NCT Number: NCT06514170
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Aortic Aneurysm|Gastrointestinal Dysfunction|Aortic Diseases|Enteral Feeding Intolerance|Surgical Complication
Interventions: OTHER: No intervention
Sponsor: Instituto Nacional de Cardiologia Ignacio Chavez
Collaborators: Instituto Nacional de Enfermedades Respiratorias|National Polytechnic Institute, Mexico
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 114
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-23
Completion Date: 2026-06
Locations: Instituto Nacional de Cardiología Ignacio Chávez, Ciudad de mexico, Tlalpan, 14080, Mexico

Summary:
The goal of this observational study is to determine the association of gastrointestinal dysfunction through the Gastrointestinal Dysfunction Scale (GIDS) tool and serum concentrations of citrulline and Intestinal fatty-acid binding protein (I-FABP) with primary \[calories received, protein received, parenteral nutrition requirement and 28-day mortality in the intensive care unit (ICU)\] and secondary (development of pneumonia, surgical and cardiovascular complications in the ICU, length of hospital and ICU stay, duration of mechanical ventilation) clinical outcomes in critically ill patients undergoing aortic surgery.

Primary Outcome Measures: Calories delivered daily enterally and/or parenterally, Percentage representation of prescribed calories delivered daily via enteral and/or parenteral routes., Day 0 to day 7|Protein delivered daily enterally and/or parenterally, Daily administration of protein (in grams) through enteral and/or parenteral routes., Day 0 to day 7
Secondary Outcome Measures: Incidence rate of hospital-acquired infections, Infections acquired in the hospital consist of ventilator-associated pneumonia, bloodstream infections, and infections related to urinary catheters, 7 days|Percentage of repeated operations, This outcome measures the percentage of patients who undergo one or more additional surgical operations related to the same condition after the initial surgery. The percentage is calculated by dividing the number of patients who require a repeat operation by the total number of patients who underwent the initial operation, multiplied by 100 to get the percentage., 90 days|ICU readmission rate, Occurrences of patients being readmitted to the ICU from within the hospital., 90 days|ICU length of stay, Duration of time (days) in the ICU, 90 days|Duration of mechanical ventilation, Length of time (days) on mechanical ventilation (including still on mechanical ventilation at time of discharge), 90 days|Hospital length of stay, Duration of time (days) in the hospital, 90 days|Parenteral nutrition requirement, Parenteral nutrition requirement, Day 0 to day 7|28-day mortality in the ICU, Is the patient alive or deceased 28 days post admission., 28 days
Exacerbations Among Patients Receiving Breztri (EROS Study)
NCT Number: NCT06514144
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Pulmonary Disease|Chronic Obstructive|Retrospective Studies
Interventions: DRUG: BGF
Sponsor: AstraZeneca
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 2409
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-10-01
Completion Date: 2023-03-07
Locations: AstraZeneca, Wilmington, Delaware, 19850, United States

Summary:
EROS was a retrospective analysis of people with COPD using the MORE2 Registry®. Inclusion required ≥1 severe, ≥2 moderate, or ≥1 moderate exacerbation while on other maintenance treatment. Primary outcomes were the rate of COPD exacerbations and healthcare costs for those that received BGF promptly. The effect of each 30-day delay in initiation of BGF was estimated using a multivariable negative binomial regression model.

Primary Outcome Measures: COPD Exacerbation events, Annualized rates of COPD exacerbation events observed from index date (qualifying exacerbation event) through study completion (until end of data availability), an average follow-up time of 331 days., Annualized rates from index exacerbation through end of data availability, an average follow-up time of 331 days.
Secondary Outcome Measures: Healthcare resource utilization, Annualized rates of health care services observed (e.g., inpatient visits, ER visits) from index date (qualifying exacerbation event) through study completion (until end of data availability), an average follow-up time of 331 days., Annualized rates from index exacerbation through end of data availability, an average follow-up time of 331 days.|Healthcare costs, Annualized costs of health care services observed (e.g., total health care costs, total-COPD related costs) from index date (qualifying exacerbation event) through study completion (until end of data availability), an average follow-up time of 331 days., Annualized costs from idex exacerbation through end of data availability, an average follow-up time of 331 days.
Water Hygiene Versus Waterless Hygiene Technology for Totally Dependent Hospitalized Patients
NCT Number: NCT06514131
Acronym: IGIENE-FAST
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Health Care Associated Infection
Interventions: PROCEDURE: Pre-moistened wipes
Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Collaborators: Azienda USL - IRCCS di Reggio Emilia|Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico|Azienda Ospedaliera, Ospedale Civile di Legnano|University of Rome Tor Vergata
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 648
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2024-02-20
Completion Date: 2024-12-20
Locations: Azienda Ospedaliera, Ospedale Civile di Legnano, Legnano, Milano, 20025, Italy|IRCCS AOU di Bologna, Bologna, 40138, Italy|Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Milano, 20122, Italy|Azienda USL-IRCCS di Reggio Emilia, Reggio Emilia, 42123, Italy|University of Rome Tor Vergata, Roma, 00133, Italy

Summary:
The aim of this randomized controlled trial is to verify whether the efficacy of perineal hygiene procedures performed in dependent patients admitted to medical or geriatric wards with pre-moistened wipes without water is higher than that found after procedures performed with disposable hand grips, soap, and water.

Primary Outcome Measures: Microbial load : effectiveness of the perineal hygiene with pre-moistened wipes, The primary objective is to verify if the effectiveness of the perineal hygiene procedures performed in hospitalized dependent patients in medicine or geriatric wards with pre-moistened wipes without water (experimental treatment) is higher than that found after the procedures performed with soapy disposable grips and water (standard treatment). Each patient will be treated with one of the two methods only once; for each patient, a total of two measurements of microbial load will be performed pre- and post-morning hygiene. Change from baseline in microbial load will be evaluated., One day
Secondary Outcome Measures: Compare the total costs of the aids used in the two hygiene methods, Cost of materials and personnel, One day|Compare the working times referred to the two hygiene methods, Time expressed in minutes, required for the completion of perineal hygiene for each methodology, One day|Compare the patients' satisfaction with the two hygiene methods, Assessed by a specific ad hoc questionnaire ranging from 2 to 10 (higher scores mean a better outcome), One day|Compare the approval of health professionals for the two hygiene methods, Assessed by a specific ad hoc questionnaire ranging from 2 to 10 (higher scores mean a better outcome), One day|Examine the patient-operator concordance regarding the different aspects relating to the liking for the two hygiene methodologies, Assessed by a specific ad hoc questionnaire (list of items), One day
Chemoimmunotherapy Plus Residual Lesion Irradiation for the Treatment of Extensive Stage Small-cell Lung Cancer
NCT Number: NCT06514118
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Small-cell Lung Cancer|Residual Tumor|Radiation
Interventions: RADIATION: residual tumor irradiation
Sponsor: Qingdao Central Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 70
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-04-17
Completion Date: 2027-03-16
Locations: Qingdao Central Hospital, Qingdao, Shandong, 266042, China|Qingdao Central Hospital, Qingdao, Shandong, 266042, China|Qingdao Central Hospital, Qingdao, Shandong, 266042, China

Summary:
This is a phase II trial studies the effect of chemoimmunotherapy sequential residual tumor irradiation in treating patients with extensive stage small cell lung cancer. Even though small cell lung cancer is initially highly responsive to first-line chemotherapy plus PD-L1 inhibitors, treatment resistance inevitably happens. Residual tumor irradiation my prolong drug resistance, and may help prevent the growth and spread of the tumor cells to other parts of the body.

Primary Outcome Measures: progression-free survival (PFS), PFS: time to disease progression or patient death, 24 months
Secondary Outcome Measures: Overall survival (OS), OS: time to patient death, 36 months
The Effect of High-intensity Laser Therapy on the Supraspinatus Tendon Using Shear Wave Elastography
NCT Number: NCT06514105
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Subacromial Impingement Syndrome
Interventions: OTHER: Physiotherapy program|OTHER: High intensity laser|OTHER: Sham high intensity laser
Sponsor: Adiyaman University
Sex: ALL
Age: ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-22
Completion Date: 2025-02-20
Locations: Adiyaman university, Adıyaman, 02000, Turkey

Summary:
Subacromial impingement syndrome, one of the most common causes of shoulder pain. In studies investigating the effectiveness of high-intensity laser in patients with subacromial impingement syndrome, it was stated that high-intensity laser reduced the complaints of patients in the early and late periods. However, there is no research examining the effect of high-intensity laser on the supraspinatus tendon. Therefore, the investigators aimed to investigate the effect of high-intensity laser on the supraspinatus tendon using shear wave elastography.

Primary Outcome Measures: Elasticity Measurement, In patients diagnosed with subacromial impingement syndrome as a result of physical examination, the degree of elasticity of the supraspinatus tendon and supraspinatus muscle on the relevant side will be evaluated numerically by Shear Wave elastography. All patients will be scanned by an expert radiologist using a high-resolution broadband linear probe with a Samsung RS 85 Prestige device. While the patients are sitting comfortably and the arm is in a neutral position, the linear probe will be placed parallel to the supraspinatus tendon and the tendon will be displayed in the longitudinal direction. Velocity and elasticity values of the muscle in kPa will be measured using 3 mm diameter range of interest (ROIs) with the help of Shear Wave elastography in the supraspinatus tendon at a distance of 0.5-1.5 cm from the tuberculum majus. For each patient, the measurement will be repeated three times and the average of these three values will be recorded., 2 weeks
Secondary Outcome Measures: Functional level, The functional level of the shoulder will be evaluated with the Shoulder Pain and Disability Scale. This scale consists of a total of 13 questions, where each question is scored between 0-10. The scores from the first 5 questions measure the pain level out of 50, and the scores from the next 8 questions measure the disability level out of 80. A high score from the scale indicates a high level of pain and disability., 2 weeks|Pain assessment, The severity of patients' shoulder pain will be evaluated with a visual analog scale (VAS). VAS: The left end of a 10 cm straight line represents no pain, and the right end represents unbearable pain. The patient will be asked to mark the pain he feels on the VAS scale during the test, and then this value will be measured and recorded with the help of a ruler., 2 weeks
Study on the Long-Term Risk of Recurrence of Anoperineal Fistula in Crohn's Disease
NCT Number: NCT06514092
Acronym: LT-SAFCD
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Crohn Disease
Interventions: OTHER: anti-TNF therapy and seton drainage
Sponsor: University Hospital, Toulouse
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 81
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-20
Completion Date: 2026-08-01
Locations: CHU de Toulouse, Toulouse, France

Summary:
This research aims to evaluate the long-term recurrence risk of perianal fistulas in Crohn's disease patients who have undergone treatment with anti-TNF therapy and seton drainage.The research seeks to identify factors influencing recurrence and assess the long term effectiveness of these treatments in preventing fistula recurrence. This study will provide insights that could enhance treatment strategies and improve patient outcomes.

Primary Outcome Measures: Long-term recurrence-free survival rate of perianal fistulas, To evaluate the long-term recurrence-free survival rate of perianal fistulas after combined treatment with anti-TNF alpha and seton drainage, through study completion, an average of 2 years