pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Outcome of Resection Anastomosis and Long Term Stenting With Montgomery Tube Operations in Management of Grade 3 Benign Laryngotracheal Stenosis
NCT Number: NCT06499987
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Grade 3 Benign Laryngotracheal Stenosis
Interventions: PROCEDURE: resection anastomosis
Sponsor: Sohag University
Sex: ALL
Age: CHILD, ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-01
Completion Date: 2025-06-01
Locations: Sohag University hospitals, Sohag, Egypt

Summary:
Laryngotracheal stenosis is a challenging problem in the field of laryngology. In the majority of patients, acquired stenosis of the larynx and trachea is due to accidental trauma, prolonged intubations, or tracheostomy. Congenital stenosis, caustic injury, and granulomatous diseases are also etiological factors in laryngotracheal stenosis (Grenier PA et al, 2009).

Tracheal stenosis can occur following tracheostomy or endotracheal intubation with inappropriate cuff pressure. It is due to pressure necrosis at the site of the cuff. Initially, there is inflammation of the damaged mucosa with increased secretion and secondary infection. Prolonged ischemia and secondary infection cause necrosis of the tracheal wall and exposure and sequestration of the cartilaginous rings. This damage results in the formation of granulation tissue and collapse of the tracheal wall (Satish Nair et al, 2014).

The tracheal stenosis is classified as simple, which is a soft, short segment web-like narrowing often limited to the mucosa only or complex stenosis, which is a hard, long-segment stricture with destruction of tracheal cartilages and fibrosis. Post tracheostomy stenosis occurs most commonly at the stoma site or less commonly at the site where the tip of the tube has impinged on the tracheal mucosa (Liu J et al, 2015).

The symptoms are generally insidious. Most arise 1 to 6 weeks after extubation, and early symptoms are often not recognized. The most common symptoms include shortness of breath, cough, recurrent pneumonia, wheezing, stridor, and cyanosis over time. Dyspnea is often the symptom until the tracheal diameter is 50% smaller than normal. When the tracheal diameter is 25% of its normal size, dyspnea and stridor may occur even at rest. These symptoms can be confused with other respiratory diseases (Rubikas R et al, 2014).

Primary Outcome Measures: successful, release of respiratory distress, 12 months
POASAC Study (Preoperative Anemia Severity and Classification Study)
NCT Number: NCT06499974
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Anemia
Sponsor: Peking Union Medical College Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-01
Completion Date: 2026-12-31

Summary:
The goal of this observational study focuses on the effect of different preoperative anemia status on perioperative complications in patients under moderate- to high-risk surgery. Different anemia types conclude iron-deficiency anemia(IDA), anemia of chronic disease/anemia of inflammation(ACD/AI), and combined anemia.The main question it aims to answer is whether there is a difference in the incidence of complication related to oxygen supply and demand imbalance in patients with IDA, ACD/AI or combined anemia.

Patients without preoperative anemia will be recruited as the control group for secondary outcome analysis, which is whether there is a difference in the incidence of complication related to oxygen supply and demand imbalance in patients with or without anemia.

Primary Outcome Measures: postoperative complications related to oxygen supply and demand imbalance, The occurrence of any of the following complications is considered a positive outcome, which include myocardial injury after non cardiac surgery(MINS), acute kidney injury(AKI), neurological damage such as stroke and delayed neurocognitive recovery(DNR), before discharge or until seven days after surgery
Secondary Outcome Measures: The incidence of post complications related to oxygen supply and demand imbalance in patients with or without anemia, The occurrence of any of the following complications is considered a positive outcome, which include myocardial injury after non cardiac surgery(MINS), acute kidney injury(AKI), neurological damage such as stroke and delayed neurocognitive recovery(DNR), before discharge or seven days after surgery|Postoperative functional disability, The World Health Organization Disability Assessment Schedule 2.0 (WHO DAS2.0) is used for disability assessment., 1 month, 6 months and 1 year after surgery|Cognitive function decline, The modified Telephone Interview for Cognitive Status(TICS-m) is used for cognitive function assessment., 1 month, 6 months and 1 year after surgery|RBC Transfusion rate, The above information can be got according to the medical record, From date of surgery until discharge day, assessed up to 4 weeks|Length of hospital stay, The above information can be got according to the medical record, From date of surgery until discharge day, assessed up to 4 weeks|Severe complication, Evaluated according to Clavien-Dindo classification, level three to five are defined as severe complication., before discharge, 1 month, 6 months and 1 year after surgery
Surgical Management of Low Grade Glioma
NCT Number: NCT06499922
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Low Grade Glioma of Brain
Interventions: PROCEDURE: SURGICAL EXCISION
Sponsor: Assiut University
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08
Completion Date: 2026-07-01

Summary:
To assess the morbidity and mortality in low grade glioma patients following surgical management.

Primary Outcome Measures: Morbidity in low grade glioma patients following surgical management., report THE RATE OF POSTOPERATIVE MORBIDITY Among participants using the neurological condition assessment ( kornofisky Scale)., 2 years
Hypnosis for Colectomies as Postoperative Pain Management
NCT Number: NCT06499909
Acronym: Hypnopal
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: to Evaluate the Effects of Clinical Hypnosis on Post-operative Pain, Following Colectomy Operations
Interventions: OTHER: Hypnosis
Sponsor: Somerset NHS Foundation Trust
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 42
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-06-06
Completion Date: 2024-04-30
Locations: Somerset NHS Foundation Trust, Taunton, Somerset, TA4 3RF, United Kingdom

Summary:
The present study intends to assess the feasibility, value and direction of conducting a future, full scale randomised controlled trial, to evaluate the effects of clinical hypnosis on post-operative pain, following colectomy operations.

Pain management in the postoperative setting presents a challenge as the development and severity of pain after surgery is dependent on different patient and procedural factors. Furthermore, pain after surgery is a major concern for patients, especially when it is undermanaged. When postoperative pain control is suboptimal it delays mobilisation, reduces oral food and fluid intake after surgery, and increases the risk of developing chronic pain and other complications. These factors have a negative impact on the patient recovery process, thus increasing the length of hospital stay and healthcare costs. Hypnosis is well recognised as having an effect in pain perception, it is a brief, easy to administer intervention making it a promising non-pharmacological intervention with the potential to help postoperative pain management in patients undergoing colectomies as well as reducing anxiety and emotional stress related to surgery, while also having a positive indirect effect on recovery times, which could lead to considerable cost-savings at organisational level.

The intervention will be delivered at Somerset NHS Foundation Trust by a designated Principal Investigator. Hypnosis sessions will be given face to face in a clinical consulting room and on the ward where the participants will be admitted after surgery. The study aims to enrol 40 participants, 20 for each arm, over 12 months, from Musgrove Park Hospital who will undergo elective colectomy surgery. Eligible participants would be adults 18 years or over, undergoing elective colectomy surgery. Participants must be able to provide a written informed consent and able to understand and communicate in English.

Primary Outcome Measures: The effectiveness of hypnotic analgesia on post-operative pain after colectomies., we are assessing the effectiveness of hypnosis on pain by using numeric pain scales to assess pain scores before and after hypnosis. This will then help us evaluate pain scores between groups and compare the before and after hypnosis scores., 365 days
Agile Development of Innovative, Interactive Hazard Recognition and Mitigation Tools/Learning E-platforms for Workers Involved in Disaster Rescue and Recovery
NCT Number: NCT06499883
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Work-related Illness
Interventions: BEHAVIORAL: Pocket Ark
Sponsor: The University of Texas Health Science Center, Houston
Collaborators: National Institute of Environmental Health Sciences (NIEHS)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 64
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-07-11
Completion Date: 2024-07-12
Locations: The University of Texas Health Science Center at Houston, Houston, Texas, 77030, United States

Summary:
The goal of this study is to assess Pocket Ark (PA), which is a mobile e-learning and assessment platform for use by flood remediation workers in the field. The purpose of the mobile application is to provide workers with real-time data to assist with making safe decisions during the planning phase in the flooded zone and provide a communications platform to improve logistics between operational bases and workers during and after the deployment to the flooded zone. Pocket Ark incorporates an action planner, scenario-based PPE training content, assessments (both knowledge and health-risk), personal security protection, and resource location features for workers involved in disaster rescue and recovery. Individual construction worker's readiness to be safely deployed to flooded and post-flood environments will be assessed.

Primary Outcome Measures: Number of participants who have increased behavioral capability as assessed by a survey, A survey will be used to assess the worker's procedural knowledge on the steps and skills to negotiate a contract and meet criteria for operational readiness for post-flood clean-up., baseline, after completion of Pocket Ark education (within 2 hours of baseline)
Secondary Outcome Measures: Usability of the Pocket Ark mobile application as assessed by the Technology Acceptance Model (TAM), Total score on the Technology Acceptance Model (TAM) ranges from 5 to 25, with a lower the score indicating greater usability., after completion of Pocket Ark education (within 2 hours of baseline)|Usability of the Pocket Ark mobile application as assessed by the System Usability Scale (SUS), Total score on the System Usability Scale (SUS) ranges from 0 to 100, with a higher score indicating greater usability., after completion of Pocket Ark education (within 2 hours of baseline)
Relugolix and Enzalutamide in Combination With Radiation Therapy for the Treatment of Very High Risk Prostate Cancer, OPTIMAL Trial
NCT Number: NCT06499870
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Prostate Adenocarcinoma
Interventions: PROCEDURE: Biopsy|PROCEDURE: Biospecimen Collection|PROCEDURE: Computed Tomography|DRUG: Enzalutamide|OTHER: Fluorine F 18 Piflufolastat|RADIATION: Image Guided Radiation Therapy|PROCEDURE: Magnetic Resonance Imaging|PROCEDURE: Positron Emission Tomography|OTHER: Questionnaire Administration|DRUG: Relugolix
Sponsor: Northwestern University
Collaborators: National Cancer Institute (NCI)
Sex: MALE
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-11-19
Completion Date: 2032-11-19
Locations: Northwestern University, Chicago, Illinois, 60611, United States

Summary:
This phase II trial tests how well relugolix and enzalutamide, in combination with radiation therapy, works in treating patients with very high risk prostate cancer. Relugolix is a form of androgen deprivation therapy. It prevents the release of testosterone, a hormone required to sustain prostate growth. Reducing testosterone levels may inhibit the proliferation of prostate tumor cells that need testosterone to grow. Enzalutamide is an androgen receptor signaling inhibitor. It inhibits the activity of prostate tumor cell receptors, which may reduce proliferation of prostate tumor cells. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Adding relugolix and enzalutamide to radiation therapy may be more effective at treating patients with very high risk prostate cancer than giving any of these treatments alone.

Primary Outcome Measures: Pathologic response (biopsy positivity rate), Will determine the efficacy of radiation therapy with relugolix and enzalutamide, for a total duration of 18 months, in patients with National Comprehensive Cancer Network very high-risk prostate cancer, by a 2-year biopsy positivity rate., At 2 years
Secondary Outcome Measures: Disease-free survival, Will be determined by biochemical failure of prostate specific antigen nadir + 2ng/mL, local or regional recurrence, distant metastasis, or death. Median survival time will be estimated with corresponding 95% confidence intervals., Up to 4 years|Testosterone recovery, Testosterone recovery will be defined as a total serum testosterone of ≥ 200 ng/dL., Up to 4 years
Comparing Approaches to Assess Nitric Oxide-dependent Cutaneous Vasodilation
NCT Number: NCT06499844
Acronym: CAP NOVA
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: EARLY_PHASE1
Conditions: Endothelial Function
Interventions: DRUG: Acetylcholine
Sponsor: University of Iowa
Sex: ALL
Age: ADULT
Enrollment: 56
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-07
Completion Date: 2025-09
Locations: University of Iowa, Iowa City, Iowa, 52242, United States

Summary:
The increase in skin blood flow in response to rapid local heating of the skin (i.e., cutaneous vasodilation) is commonly used to assess nitric oxide (NO)-dependent dilation and overall microvascular function. Historically, rapid local heating to 42°C was considered the standard approach for these assessments. More recently, many investigators have adopted rapid local to 39°C instead, based on its larger dependency on NO and therefore improved ability to quantify NO-dependent dilation without the use of pharmacological techniques. However, to date, only one direct methodological comparison between these protocols has been performed.

In this study, the investigators use the blood vessels in the skin as a representative vascular bed for examining mechanisms of microvascular dysfunction in humans. Using a minimally invasive technique (intradermal microdialysis for the local delivery of pharmaceutical agents) they examine the blood vessels in a nickel-sized area of the skin in young adults ages 18 - 30 years old. Local heating of the skin at the microdialysis sites is used to explore differences in mechanisms governing microvascular control. As a compliment to these measurements, the investigators also have participants fill out a variety of surveys to assess things such as sleep quality, physical activity, daily stressors, etc.

Primary Outcome Measures: Microvascular blood flow response to acetylcholine, cutaneous vascular vasodilator response to exogenous acetylcholine perfusion; measured with laser-Doppler flowmetry coupled with intradermal microdialysis delivery of acetylcholine alone or co-infused with L-NAME, baseline study visit (average of 4 hours)|Microvascular blood flow response to local heat (42 degrees Celsius), cutaneous vascular vasodilator response to 42 degree local heat; measured with laser-Doppler flowmetry coupled with intradermal microdialysis delivery of lactated Ringer's, followed by L-NAME., baseline study visit (average of 4 hours)|Microvascular blood flow response to local heat (39 degrees Celsius), cutaneous vascular vasodilator response to 39 degree local heat; measured with laser-Doppler flowmetry coupled with intradermal microdialysis delivery of lactated Ringer's, followed by L-NAME., baseline study visit (average of 4 hours)
CPVI Alone Versus CPVI Plus Low-Voltage Areas Ablation During SR Versus CPVI Plus Low-Voltage Areas Ablation During AF for the Treatment of CAF
NCT Number: NCT06499818
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Atrial Fibrillation
Interventions: PROCEDURE: STABLE-SR|PROCEDURE: STABLE-AF|PROCEDURE: CPVI
Sponsor: Yantai Yuhuangding Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 150
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-07-15
Completion Date: 2026-12-15

Summary:
The primary objective of this investigation is to compare the efficacy of Three different AF ablation strategies in patients with Persistent atrial fibrillation: CPVI plus Low-Voltage Areas ablation during sinus rhythm Versus. CPVI Plus Low-Voltage Areas Ablation During AF and CPVI alone.

Primary Outcome Measures: The incidence of no atrial arrhythmias greater than 30 seconds, The incidence of no atrial arrhythmias greater than 30 seconds, at least 18 months follow up
Secondary Outcome Measures: No use of antiarrhythmic drugs and no occurrence of atrial fibrillation exceeding 30 seconds, No use of antiarrhythmic drugs and no occurrence of atrial fibrillation exceeding 30 seconds, at least 18 months follow up|No use of antiarrhythmic drugs and no occurrence of atrial tachycardia/flutter exceeding 30 seconds, No use of antiarrhythmic drugs and no occurrence of atrial tachycardia/flutter exceeding 30 seconds, at least 18 months follow up|Atrial fibrillation load, Atrial fibrillation load, at least 18 months follow up|Procedure time, time that the patient spend in the procedure room, Surgical procedure|Ablation time, the total Ablation time, during CPVI and after CPVI, 1 week after patient enrollment|Incidence of peri-procedural complications, stroke, PV stenosis, cardiac perforation, esophageal injury and death, at least 18 months follow up
Effectiveness of the Transversus Abdominis Plane Block Associated With Opioid Spinal Anesthesia on Analgesia After Cephalic Duodenopancreatectomy
NCT Number: NCT06499792
Acronym: DPC-RATAP
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Pancreatic Cancer
Sponsor: University Hospital, Strasbourg, France
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 160
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-01-03
Completion Date: 2024-12-31
Locations: Service d'Anesthésiologie - Réanimation Chirurgicale - CHU de Strasbourg - France, Strasbourg, 67091, France

Summary:
Duodenopancreatectomy is a major, risky surgery that causes significant post-operative pain. Optimizing perioperative analgesia remains a challenge, and requires multimodal management, notably involving locoregional analgesic techniques.

The thoracic epidural helps reduce perioperative pain, as well as certain postoperative complications. However, epidural analgesia is not without effects, and the data remains quite heterogeneous depending on the studies regarding its benefits and risks: more frequent hypotension, significant technical failures, length of hospitalization depending on the series, marginal benefit clinically of little relevance... And the existence of contraindications to the epidural such as the performance of vascular resections requiring curative intraoperative anticoagulation also limit its daily use.

The search for alternatives to the epidural in this context has seen the emergence of the use of intrathecal injection of Morphine and the performance of TAP Block perioperatively for duodenopancreatectomies. Morphine spinal anesthesia is an analgesic technique that is simpler and just as effective as the thoracic epidural. The TAP Block has also proven its effectiveness in major colorectal surgeries.

The literature on the subject remains poor and very few studies have focused on alternatives to thoracic epidurals. If the superiority of TAP Block and spinal anesthesia have been evaluated in isolation, no study has yet compared the effectiveness of the combination of TAP Block-Spinal anesthesia compared to that of TAP Block alone in the management of post pain. duodenopancreatectomy.

At the Strasbourg University Hospital, the Anesthesia team in hepatic and pancreatic surgery made a change in practice in June 2023: from a TAP Block, the team performs a TAP-Block combined with a unique Morphinic spinal anesthesia preoperatively for cephalic duodenopancreatectomy (CDP). The objective of the study is to evaluate the effectiveness and safety of this change in practice.

Primary Outcome Measures: Consumption of Morphine in the first 24 hours postoperatively., Quantitative variables are described using the usual position and dispersion statistics, namely mean, median, minimum, maximum, standard deviation and quantile. The qualitative variables are described with the numbers and proportions of each modality. The Chi2 test will be used to study the crossover between several qualitative variables. The risk of the first kind is set at 5% for all analyses., Up to 1 year
Prescription of Valproate and Derivatives in Women of Childbearing Age: Qualitative Study
NCT Number: NCT06499779
Acronym: VALPRO
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Psychiatric Disorder
Sponsor: University Hospital, Strasbourg, France
Sex: FEMALE
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-01-02
Completion Date: 2026-05-02
Locations: Service de Psychiatrie 2 - CHU de Strasbourg - France, Strasbourg, 67091, France

Summary:
The prescription of valproate in women of childbearing age has decreased by 82% in France, for mood disorders. Exposure to valproate during pregnancy 60%. However, the ANSM sent an alert document in August 2022 because there are still patients on valproate. In addition, there were 32 births taking valproate to mothers with bipolar disorder in 2018. The risks of exposure during pregnancy which occur in 10% of exposure cases are: congenital malformations; neurodevelopmental disorders including autism spectrum disorders, attention deficit disorders more or less hyperactivity, language disorders, motor disorders, mental delays; reduction in social, attentional, motor and language abilities; a lower level of education.

Primary Outcome Measures: Cause of valproate prescription in women of childbearing age, Calculation of percentages, mean, median, standard deviation The results will be considered significant at the 5% threshold., Up to 2 years
Methodological Study of the Effect of a Lotion Containing Nature Based Microbial Extract on Atopic Skin
NCT Number: NCT06499766
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Atopic Dermatitis
Interventions: OTHER: Biodiversity intervention by inactivated microbial extract|OTHER: Placebo intervention by colored lotion
Sponsor: Uute Scientific Oy
Collaborators: Tampere University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 12
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: OTHER
Start Date: 2022-11-11
Completion Date: 2022-12-09
Locations: Uute Scientific Oy, Helsinki, 00290, Finland

Summary:
The purpose of the study is to test the selected methods and to explore the effect of nature-based exposure on immunological biomarkers and the condition of atopic skin. Overall purpose is to test the safety and feasibility of a new nature-exposure method on atopic skin: regular use of lotion containing inactivated microbial extract that mimics Finnish forest microbial biodiversity.

Primary Outcome Measures: Transepidermal water loss (TEWL), TEWL measurement from each test area (arms), 0, 14 and 28 days
Secondary Outcome Measures: Skin erythema index, Erythema index measurement from each test area (arms), 0, 14 and 28 days|SCORAD (SCORing Atopic Dermatitis), Scoring of atopic dermatitis (whole body) by dermatologist. Scale 0-103., 0 and 28 days|Local scoring of eczema on arms, Local scoring of eczema only on arms (each arm separately) by dermatologist. Scale 0-18., 0 and 28 days|Pro-inflammatory cytokines on skin, Tape strip samples from both arms and cytokine analysis from the samples., 0 and 28 days|Self evaluation of eczema symptoms and effect of the lotion, Filling of self questionnaire every week, 0, 7, 14, 21 and 28 days
Differences in Dry Eye Symptoms Related to Geographic Location in Spain and Impact of Artificial Tears Use
NCT Number: NCT06499753
Acronym: EMO-01
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Dry Eye Syndromes|Hyaluronic Acid|OSDI
Interventions: OTHER: high molecular weight HA-based artificial tears
Sponsor: University of Valladolid
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1033
Study Design: Observational Model: |Time Perspective: p
Start Date: 2020-02-01
Completion Date: 2022-01-31
Locations: IOBA Eye Institute, Valladolid, 47011, Spain

Summary:
This study assessed the differences in DED symptomatology measured with the OSDI questionnaire regarding climate data of the geographic location in a large population in Spain, with a special focus on the relative humidity (RH) of the place of residence and the impact of artificial tears use, to help eye care practitioners in patient management and education

Primary Outcome Measures: OSDI Score, Change in the Ocular Surface Disease Index (OSDI) score ranged from 0 (asymptomatic) to 100 (severe dry eye), three months
HighCycle Study: Effect of High Altitude on Acute Mountain Sickness in Women Related to Their Menstrual Cycle Phase
NCT Number: NCT06499714
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Acute Mountain Sickness
Interventions: OTHER: Exposure to 3600 m
Sponsor: University of Zurich
Collaborators: National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov|University Hospital Heidelberg|Laboratoire des Adaptations Métaboliques à l'Exercice en conditions Physiologiques et Pathologiques
Sex: FEMALE
Age: ADULT
Enrollment: 90
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-15
Completion Date: 2025-12-31
Locations: National Center for Cardiology and Internal Medicine, Bishkek, 720040, Kyrgyzstan

Summary:
Prospective cohort study investigating the menstrual cycle phase (MCP)-dependent incidence of acute mountain sickness (AMS) in women travelling to 3600 m.

Primary Outcome Measures: Acute Mountain Sickness (AMS) Incidence, LLS 2018, MCP-related difference in the AMS incidence. AMS incidence will be defined as a Lake Louise Questionnaire version 2018 score of ≥3., Day 1 to 3 at 3600 m
Secondary Outcome Measures: Acute Mountain Sickness (AMS) Incidence, LLS 1993, MCP-related difference in the AMS incidence. AMS incidence will be defined as a Lake Louise Questionnaire version 1993 score of ≥3., Day 1 to 3 at 3600 m|Acute Mountain Sickness (AMS) Severity, LLS 2018, MCP-related difference on the AMS severity assessed by the Lake Louise Questionnaire version 2018., Day 1 to 3 at 3600 m|Acute Mountain Sickness (AMS) Severity, LLS 1993, MCP-related difference on the AMS severity assessed by the Lake Louise Questionnaire version 1993., Day 1 to 3 at 3600 m|Arterial blood gases, MCP-related difference on the arterial blood gases (pH, PaO2, PaCO2, SaO2)., Day 2 at 760 m and day 2 at 3600 m|Hypoxic ventilatory response, MCP-related difference in the hypoxic ventilatory response assessed under FiO2 of 0.115 and while cycling on a bicycle at 30% of predicted maximal work capacity., Day 2 at 760 m|Perceived pain visualization, MCP-related difference on perceived pain sensations, visualized by the SMaRT tablet app, Day 1 to 3 at 3600 m
Volume Kinetics of Fluid Resuscitation in Early Sepsis
NCT Number: NCT06499701
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Fluid and Electrolyte Imbalance
Interventions: DRUG: Ringer's Lactate
Sponsor: Institutul de Urgenţă pentru Boli Cardiovasculare Prof.Dr. C.C. Iliescu
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 15
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-19
Completion Date: 2025-01-01
Locations: Clinical Hospital Of Infectious Diseases "Dr. Victor Babes", Bucharest, București, 030303, Romania|"Prof CC Iliescu" Emergency Institue for Cardiovascular Diseases, Bucharest, 022328, Romania

Summary:
The recommended volume resuscitation for patients with early sepsis-induced hypoperfusion is at least 30 ml/kg of crystalloid administered within the first three hours. However, this standardized approach does not account for individual patient variability and lacks personalization. Additionally, the effects of administering 30 ml/kg on intercompartmental fluid shifts between the plasma and interstitial compartments remain unclear. This study aims to describe the volume kinetics of administering 30 ml/kg of Ringer's Lactate in patients with early sepsis-induced hypoperfusion within the first three hours.

Primary Outcome Measures: Plasma Volume, Plasma volume (ml) was determined using a three-compartment kinetic model with five rate constants (k12, k21, k23, k32 and k10) and a scaling factor (Vc, central volume) that relates dilution to volume. This model was applied to the dependent variables, which included frequently measured plasma dilution and urinary excretion., 180 minutes after the start of the Ringer's Lactate infusion
Prevalence of Steatosis and Steatohepatitis in Patients Undergoing Bariatric Surgery; a Biopsy-based Study
NCT Number: NCT06499675
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Obesity|Obesity, Morbid|Bariatric Surgery Candidate|Steatosis of Liver|Steatohepatitis, Nonalcoholic
Interventions: PROCEDURE: sleeve gastrectomy|PROCEDURE: Liver Biopsy
Sponsor: Egyptian Liver Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 272
Study Design: Observational Model: |Time Perspective: p
Start Date: 2019-05-01
Completion Date: 2024-05-31
Locations: Egyptian Liver Research Institute and Hospital (ELRIAH), Shirbīn, Ad Daqahliyah, 35111, Egypt

Summary:
To study the prevalence of steatosis, steatohepatitis, and their associated risk factors in obese patients undergoing bariatric surgery.

Primary Outcome Measures: Compare the histological assessment of steatosis and steatohepatitis with non invasive procedures., Compare the histological assessment of steatosis and steatohepatitis with non invasive procedures., 55 months
Randomised Clinical Trial to Determine the Effect of Vagus Nerve Neurodynamics on the Neurovegetative Nerve System in People With Chronic Stress.
NCT Number: NCT06499662
Acronym: VNN-HRV-CCS
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Stress, Psychological Cumulative|Chronic Disease|Heart Rate Variability|Vagal Nerve Stimulation|Autonomic Nervous System Diseases
Interventions: OTHER: Vagus Nerve Neurodynamics|OTHER: Guided Breathing|OTHER: Manual Therapy
Sponsor: Marta de la Plaza
Collaborators: Universidad Rey Juan Carlos
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 62
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-03-23
Completion Date: 2024-07-07
Locations: Marta de la plaza, Madrid, 28670, Spain

Summary:
This unicentric, controlled clinical trial aims to evaluate the effects of vagus nerve neurodynamics and 6 bpm guided breathing, combined with manual therapy, on heart rate variability (HRV) in patients suffering from chronic stress. A total of 62 participants will be randomly assigned into two groups: one receiving guided breathing and neurodynamics with manual therapy, and the other receiving only guided breathing with manual therapy. HRV will be monitored using Polar® H10 sensors. The primary outcome is the change in HRV, measured pre- and post-intervention. The study is ethically approved by the Hospital Clínico San Carlos.

Primary Outcome Measures: Change in Heart Rate Variability (HRV), The primary outcome measure is the change in heart rate variability (HRV) from baseline to post-intervention. HRV will be measured using a Polar® H10 sensor band placed on the participants' chest. HRV data will be recorded during a 7-minute period before the intervention (at rest), during the 15-minute intervention, and during a 7-minute period after the intervention (at rest). Specific HRV parameters to be analyzed include RMSSD (Root Mean Square of the Successive Differences), pNN50 (percentage of adjacent NN intervals that differ by more than 50 ms), and high-frequency power (HF power)., From the start of the study until 7 minutes post-intervention.
Assessment of the Adjuvant Role of Dietary Supplementation of Antibiotic-tolerant Probiotics in Standard Therapy for the Eradication of Helicobacter Pylori Infection.
NCT Number: NCT06499649
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Helicobacter Pylori Infection
Interventions: DIETARY_SUPPLEMENT: IBSA Probiotics|DIETARY_SUPPLEMENT: Placebo
Sponsor: IBSA Farmaceutici Italia Srl
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 270
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-03
Completion Date: 2025-05-31
Locations: Policlinico S. Orsola - Malpighi - Università di Bologna, Bologna, 40138, Italy

Summary:
Randomized, double-blind, placebo-controlled clinical study to assess the adjuvant role of dietary supplementation of antibiotic-tolerant probiotics, derived from Lactobacillus acidophilus and Bifidobacterium animalis, in standard therapy for the eradication of Helicobacter pylori infection.

Primary Outcome Measures: EACTE (Adverse Events Correlated to Eradication Therapy) incidence, Assessment of the incidence of "Adverse events related to eradication therapy" regardless of the degree of severity, in the group taking the dietary supplement with probiotic, compared to the group taking placebo. The adverse events related to eradication therapy are those described by the EACTE Assessment Questionnaire used, T0 (basal) - T1 (20 ± 3 days after T0)
Secondary Outcome Measures: EACTE severity, Assessment of the variation in severity of EACTE in the probiotic group compared to the placebo group., T0 (basal) - T2 (48 ± 3 days after T0)|Eradication rate of H. pylori, Percentage difference of eradication rate between placebo and treated groups, T2 (48 ± 3 days after T0)|Severe EACTE, Difference between the percentage of subjects with at least one severe EACTE between the group taking probiotic treatment and the group taking placebo, T0 (basal) - T1 (20 ± 3 days after T0)|GSRS (Gastrointestinal Symptom Rating Scale) score, Difference of GSRS score between placebo and treated groups., T2 (48 ± 3 days after T0)
Other Outcome Measures: Safety Evaluation, Adverse Events registration, T1 (20 ± 3 days after T0) and T2 (48 ± 3 days after T0)
Early Detection of Malnutrition in Oncology Patients and Elderly Patients
NCT Number: NCT06499623
Acronym: MALNUTRITION
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Malnutrition
Interventions: DIAGNOSTIC_TEST: Blood test|DIAGNOSTIC_TEST: Bioelectrical Impedance Analysis|OTHER: Nutritional Risk Assessment Questionnaire
Sponsor: Institute of Health Information and Statistics of the Czech Republic
Collaborators: Brno University Hospital|Bulovka Hospital|Masaryk Memorial Cancer Institute|University Hospital, Motol|Hospital AGEL Nový Jičín a.s.|Military University Hospital, Prague|General University Hospital, Prague|University Hospital Olomouc|University Hospital Pilsen
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 2000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-20
Completion Date: 2026-03-31
Locations: Brno University Hospital, Brno, 60200, Czechia|Masaryk Memorial Cancer Institute, Brno, 60200, Czechia|Hospital AGEL Nový Jičín a.s., Nový Jičín, Czechia|University Hospital Olomouc, Olomouc, Czechia|University Hospital Pilsen, Pilsen, Czechia|Bulovka Hospital, Prague, Czechia|General University Hospital, Prague, Prague, Czechia|Military University Hospital, Prague, Prague, Czechia|University Hospital, Motol, Prague, Czechia

Summary:
The project is a national, prospective, multicenter, non-interventional pilot project of malnutrition screening in the Czech Republic.

The main goal of the project is to methodically prepare, implement and evaluate a pilot project that will verify the suitability of the proposed procedure for the early detection of malnutrition in oncology patients and hospitalised patients patients 65 years of age and older, as this has a significant effect on the quality of life and the effectiveness of the services provided oncological treatment.

Primary Outcome Measures: Number of people with malnutrition according to the PSNPO questionnaire, Until 31. 3. 2026
Secondary Outcome Measures: Proportion of people with initiated nutritional intervention, Until 31. 3. 2026
Study of the Fine Structure and Temporal Envelope of the Human Cochlea in Response to Human Vocalizations
NCT Number: NCT06499584
Acronym: CosySpeech
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Structure Cochlea|Temporal Envelope Cochlea
Interventions: PROCEDURE: near field recording of human auditory nerve activity during retro sigmoid approach with contact electrode
Sponsor: CHU de Reims
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2023-03-21
Completion Date: 2027-12
Locations: Damien JOLLY, Reims, France

Summary:
In humans, surface electrophysiological recordings of the cochlear nerve in response to a sound stimulus provide information about the cochlear's ability to encode sound. Depending on the stimulus, the fine structure and temporal envelope of the signal will vary, allowing us to determine its characteristics. By phenotyping patients before surgery using subjective and objective audiometric tests, it will be possible to isolate for each patient the moment when the fine structure disappears and when the temporal envelope is effective.

Primary Outcome Measures: To compare the amplitude of coding of complex and ecological sounds, The goal is to compare the amplitude of coding of complex and ecological sounds (logatomes in the form of vowels or syllables: association of a consonant and a vowel) in the human auditory nerve between patients defined as normo and poorly hearing according to preoperative audiometric tests., At 48 months|To compare the spectrum of coding of complex and ecological sounds, The goal is to compare the spectrum of coding of complex and ecological sounds (logatomes in the form of vowels or syllables: association of a consonant and a vowel) in the human auditory nerve between patients defined as normo and poorly hearing according to preoperative audiometric tests., At 48 months
Secondary Outcome Measures: The spectrum of the temporal envelope of the signal, To study the spectrum of the temporal envelope of the signal collected for each logatome in the general population studied and within the normal-hearing and hard-of-hearing groups., At 48 months|The amplitude of the temporal envelope of the, To study the amplitude of the temporal envelope of the signal collected for each logatome in the general population studied and within the normal-hearing and hard-of-hearing groups., at 48 months|The spectrum of the fine structure of the signal, To study the spectrum of the fine structure of the signal collected for each logatome in the general population studied and within the normal-hearing and hard-of-hearing groups., at 48 months|The amplitude of the fine structure of the signal, To study the amplitude of the fine structure of the signal collected for each logatome in the general population studied and within the normal-hearing and hard-of-hearing groups., at 48 months
Teaching Family Planning Skills With Standardized Patients"
NCT Number: NCT06499558
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Educational Problems
Interventions: OTHER: Classical Training|OTHER: Standard Patient Interviews
Sponsor: Suleyman Demirel University
Sex: ALL
Age: ADULT
Enrollment: 80
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-05-31
Completion Date: 2024-06-05
Locations: Suleyman Demirel University Health Sciences Faculty Nursing Department, Isparta, Çünür, 32260, Turkey

Summary:
The research is planned to be carried out in the Simulated Patient Laboratory of Süleyman Demirel University Faculty of Medicine. The population of the research will consist of students taking the Hem 327 Women's Health and Diseases Nursing course in the fall semester of the 2023-2024 academic year (N: 179). Students receive training in small groups of 30-40 people in the professional skills laboratory. It is planned to study with a total of 80 students, 40 in the intervention group and 40 in the control group. Students will be assigned to intervention and control groups by lottery. The entire intervention and control group will receive theoretical training on "Family Planning", which is included in the 327 Women's Health and Diseases Nursing course. The course, conducted by the research faculty member using lecture, question-answer and discussion methods, will last three hours. Students participating in the study during the week of the theoretical course will be asked to fill out the Introductory Characteristics Form and the Family Planning Counseling Information Form.

Primary Outcome Measures: Standard patient practice has an impact on students' satisfaction level., Student Satisfaction and Confidence Scale in Learning, through study completion, an average of 6 month
Secondary Outcome Measures: The effect of standardized patient practice on students' self-confidence has been investigated, Family Planning Counseling Information Form, Effective Communication Form,Family Planning Education Skills Assessment Form, through study completion, an average of 6 month
Plantar Pressures After Pressure Release of the Flexor Digitorum Brevis Muscle Versus a Non-emission Laser.
NCT Number: NCT06499545
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Manual Therapy|Myofascial Pain Syndrome|Foot|Flat Foot
Interventions: OTHER: Pressure release|OTHER: Non emision Laser
Sponsor: Mayuben Private Clinic
Sex: ALL
Age: ADULT
Enrollment: 36
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: OTHER
Start Date: 2024-07-24
Completion Date: 2024-08-03
Locations: Mayuben Clinic, San Sebastián De Los Reyes, Madrid, 28702, Spain

Summary:
In this study we will test the effects of pressure release on the Flexor digitorum brevis muscle on the plantar pressures variables using a pressure platform.

Primary Outcome Measures: Variables of plantar pressures with platform before non-emission laser, For 30 seconds we will record the plantar pressure variables in grams per square centimetre., Through study completion, an average of 2 days|Variables of plantar pressures with platform before pressure release, For 30 seconds we will record the plantar pressure variables in grams per square centimetre., Through study completion, an average of 2 days|Variable footprint planting surface with platform before non-emission laser, For 30 seconds we will record the area of the footprint in square centimetres., Through study completion, an average of 2 days|Variable footprint plantar surface with platform before pressure release, For 30 seconds we will record the plantar pressure variables in grams per square centimetre., Through study completion, an average of 2 days|Variables of plantar pressures with platform after non-emission laser, For 30 seconds we will record the plantar pressure variables in grams per square centimetre., Through study completion, an average of 2 days|Variables of plantar pressures with platform after preassure release, For 30 seconds we will record the plantar pressure variables in grams per square centimetre., Through study completion, an average of 2 days|Variable footprint planting surface with platform after non-emission laser, For 30 seconds we will record the area of the footprint in square centimetres., Through study completion, an average of 2 days|Variable footprint planting surface with platform after pressure release, For 30 seconds we will record the area of the footprint in square centimetres., Through study completion, an average of 2 days
The Frequency of Trigeminocardiac Reflex During the Extraction of Impacted Mandibular Wisdom Teeth
NCT Number: NCT06499532
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Trigemino-Cardiac Reflex|Impacted Third Molar Tooth
Interventions: PROCEDURE: Monitoring and Surgical removal of mandibular impacted wisdom teeth, using Gow-Gates anesthesia technique|PROCEDURE: Monitoring and Surgical removal of mandibular impacted wisdom teeth, using inferior alveolar nerve block anesthesia technique
Sponsor: Kutahya Health Sciences University
Sex: ALL
Age: ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, CARE_PROVIDER)|Primary Purpose: SCREENING
Start Date: 2023-10-01
Completion Date: 2023-11-10
Locations: Kutahya University of Health Sciences, Kütahya, 43100, Turkey

Summary:
The goal of this clinical trial is to investigate trigeminocardiac reflex (TCR) formation during surgical extraction of mandibular impacted wisdom teeth in healthy adults. The main questions it aims to answer are:

* How often is the TCR encountered during the extraction of impacted mandibular wisdom teeth?
* Do different local anesthesia techniques affect the frequency of this reflex?
* Is the relationship between the impacted teeth and the inferior alveolar nerve a predisposing factor for the development of this reflex

Researchers will monitor patients included in the study during the extraction of impacted mandibular wisdom teeth.

Patients will undergo an anxiety test, and those found to be anxious will be excluded from the study (to avoid vasovagal events).

During the procedure, at seven different surgical stages, blood pressure, oxygen saturation, and heart rate data will be recorded at the beginning and end of each stage.

The monitoring of TCR was conducted by observing a sudden bradycardia that developed within a few seconds and resolved when the procedure was paused, not preceded by any tachycardia. TCR will be investigated at three different levels according to different reference values in the literature.

Primary Outcome Measures: Heart rate monitoring, All patients in all research arms monitored prior to extraction of impacted mandibular wisdom teeth had their heart rate monitored throughout the procedure., During the operation|Systolic, and diastolic blood pressure monitoring, All patients in all research arms monitored prior to extraction of impacted mandibular wisdom teeth had their systolic, and diastolic blood pressure monitored throughout the procedure., During the operation|Oxygen saturation monitoring, All patients in all research arms monitored prior to extraction of impacted mandibular wisdom teeth had their oxygen saturation monitored throughout the procedure., During the operation