pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Real-World Effectiveness of a Triple Combination BDP/FF/GB in a Single Pressurised Metered Dose Inhaler in COPD Patients (TRIPHY)
NCT Number: NCT06480890
Acronym: TRIPHY
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Chronic Obstructive Pulmonary Disease
Sponsor: Chiesi Farmaceutici S.p.A.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 359
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-02
Completion Date: 2025-10-15
Locations: The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China

Summary:
The purpose of the study is to evaluate Real-World Effectiveness of a Triple Combination Beclometasone Diproprionate/Formoterol Fumarate/Glycopyrronium Bromide (BDP/FF/GB) in a Single Pressurised Metered Dose Inhaler (Trimbow® pMDI) in Subjects with Chronic Obstructive Pulmonary Disease (COPD).

Primary Outcome Measures: Effectiveness Measure, COPD Assessment Test total score, After 12-weeks of treatment with BDP/FF/GB on disease status
Secondary Outcome Measures: Effectiveness Measure, Number and percentage of responders (i.e. subjects with a change from baseline in CAT total score ≤ -2) or non-responders (i.e. subjects with a change from baseline in CAT total score \> -2 or with CAT total score at Week 12 missing)., After 12-weeks of treatment with BDP/FF/GB|Effectiveness Measure, Mean absolute change from baseline in specific lung function parameter values (i.e. FEV1, FEV1 % of predicted, PEF) after 12 weeks of treatment with BDP/FF/GB., After 12-weeks of treatment with BDP/FF/GB|Effectiveness Measure, Mean absolute change from baseline in specific laboratory parameter values (i.e. eosinophil count) after 12 weeks of treatment with BDP/FF/GB., After 12-weeks of treatment with BDP/FF/GB|Safety Measure, Overall summary of AEs will be presented the number of subjects and percentage of subjects with any AEs., After 12-weeks of treatment with BDP/FF/GB|Safety Measure, Overall summary of adverse drug reactions (ADRs) will be presented with the number of subjects and percentage of subjects with any ADRs., After 12-weeks of treatment with BDP/FF/GB|Safety Measure, The number and percentage of subjects with any special situations will be summarised., After 12-weeks of treatment with BDP/FF/GB
Other Outcome Measures: Treatment Adherence, Treatment adherence, by Test of Adherence to Inhaler (TAI), After 12-weeks of treatment with BDP/FF/GB
Effect of Aerosol From THS and Cigarette Smoke on Periodontal Tissues and Its Microbiome
NCT Number: NCT06480877
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Periodontal Diseases|Dysbiosis
Interventions: DIAGNOSTIC_TEST: Taking a swab from periodontal pockets or gingival sulci
Sponsor: Clinical Hospital Center Rijeka
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 66
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-06-01
Completion Date: 2023-06-01
Locations: Clinical medical hospital centre Rijeka, Rijeka, 51000, Croatia

Summary:
Cigarette smoke has an adverse effect on the entire body as well as on the supporting apparatus of the teeth. THS (tobacco heating system) are new products on the market in which tobacco is heated and not burned like in classic cigarettes. Cigarette smoke negatively affects the immune system and vascularization, while the microbiological diversity of the dental biofilm of smokers shows a high prevalence of periodontal pathogens. The effect of THS aerosols on periodontal tissues has not been fully investigated. The research would focus on the impact of cigarette smoking and THS on periodontal tissues and compare their effects as measured by periodontal indices and subgingival microbiome analysis. Periodontal indices will give an insight into the health condition of the periodontal tissues. The microbiological profile of the subgingival areas will serve as an indicator of the effect of cigarette smoke and aerosol emitted by THS on the specific subgingival microbiome. Changes in the composition of the oral subgingival microbiome caused by environmental factors such as smoking will be analyzed using Next generation sequencing (NGS).

Primary Outcome Measures: Periodontal indices, Three groups were formed (each N = 22): (I) subjects smoking classic cigarettes, (II) users of tobacco heating devices , and (III) subjects who have never smoked either classic cigarettes or used the THS system. Subjects were further classified into subgroups with periodontitis and without periodontitis. The procedure of each subject consisted of taking anamnestic data, clinical examination of the oral cavity, analysis of panoramic dental radiographs, and taking paper-point sample swabs from gingival sulci or periodontal pockets. Clinical examination included examination of all teeth except third molars. A millimeter graduated PCP-15 UNC periodontal probe (Hu-Friedy, Chicago, IL, USA) was used to record the following periodontal indices: probing depth , Full Mouth Bleeding Score , Full Mouth Plaque Score, gingival recession, tooth mobility, furcation defects, and clinical attachment level., 1 year
Secondary Outcome Measures: results from 16S rRna sequencing, 330 paper-point samples from periodontal pockets were collected. Next-generation sequencing of 16S rRNA genes was conducted to identify the composition of subgingival microbiome, 1 year
Adebrelimab Plus Apatinib for Maintenance Therapy of Extensive Small Cell Lung Cancer
NCT Number: NCT06480864
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Small Cell Lung Cancer
Interventions: DRUG: Adebrelimab Injection|DRUG: Apatinib Mesylate Tablets|DRUG: Carboplatin|DRUG: Cisplatin|DRUG: Etoposide
Sponsor: Yunpeng Liu
Collaborators: Jiangsu HengRui Medicine Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 38
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07
Completion Date: 2026-08
Locations: The First Hospital of China Medical University, Shenyang, 110000, China

Summary:
To evaluate the efficacy and safety of maintenance therapy with Adebrelimab plus Apatinib for extensive small cell lung cancer after first-line induction of Adebrelimab plus chemotherapy.

Primary Outcome Measures: Progression-free survival (PFS), To evaluate the efficacy of anti-tumor by Resist1.1 (In months), baseline up to approximately 6 month
Secondary Outcome Measures: Objective response rate (ORR), To evaluate the efficacy of anti-tumor by Resist1.1 (In percent), baseline up to approximately 6 month|Disease control rate (DCR), To evaluate the efficacy of anti-tumor by Resist1.1(In percent), baseline up to approximately 6 month|Duration of Response (DOR), To evaluate the efficacy of anti-tumor by Resist1.1(In months), baseline up to approximately 12 months|Overall survival (OS), To evaluate the efficacy of anti-tumor by Resist1.1(In months), baseline up to approximately 12 month|Second progression-free survival (PFS2), To evaluate the efficacy of anti-tumor by Resist1.1(In months), baseline up to approximately 12 months|Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability], To identify the incidence of AE and SAE in clinical trial, From the initiation of the first dose to 28 days after the last dose
Other Outcome Measures: Correlation of biomarkers and tumour response, Biomarkers Include: haematopoietic factors in pg/mL (IL-6,IL-8, IL-10, etc.), PD-L1 expression in TPS, T-cell subsets in percent, T-cell immunoprecision typing and regulatory T-cell counts in percent., baseline up to approximately 12 months
Application of Ultra-high Frequency Ultrasonography (UHFUS) to the Study of Gingival Tissues
NCT Number: NCT06480825
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Gingivitis|Periodontitis
Interventions: OTHER: Performance of ultrasonographic scan
Sponsor: University of Pisa
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-04-02
Completion Date: 2024-12
Locations: University of Pisa, Pisa, 56126, Italy|Department of Surgical, Medical and Molecular Pathology and Critical Care Medicine, University Hospital of Pisa, Pisa, Italy

Summary:
Gingival inflammation triggered by the accumulation of bacterial is the primary risk factor for the development of periodontitis. Clinically, localized signs of inflammation limited to the gingiva, presence of significant bacterial plaque load, and stable attachment levels on the periodontium can be observed in course of gingivitis. The aim of the present study is to compare clinical aspects of gingival tissue in healthy patients versus patients with gingivitis to assess the ultrastructural variations present in course of inflammation.

Patients with gingivitis and healthy controls will be enrolled. All patients will undergo ultra-high frequency ultrasonographic scans (70 MHz) of gingival tissue on three areas per dental arch (anterior, middle right, middle left). Gingival thickness, echogenicity, and vascularization assessed through resisitive index will be evaluated.

Primary Outcome Measures: Echogenicity, Variations in echogenicity assessed through grey levels distribution between healthy patients versus gingivitis, measured once at enrollemnt
Secondary Outcome Measures: Vascular parameters, Variations in vascularization assessed through grey levels distribution between healthy patients versus gingivitis, measured once at enrollemnt
The Role of Synbiotics in Modulating Host Physiology Via the Gut Microbiome
NCT Number: NCT06480812
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Healthy
Interventions: DIETARY_SUPPLEMENT: Synbiotic
Sponsor: Elizabeth Simpson
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2023-07-24
Completion Date: 2024-12-22
Locations: University of Nottingham, Nottingham, NG7 2UH, United Kingdom

Summary:
The current study is a proof of concept mechanistic study that will utilise a combination of prebiotic and probiotic (synbiotic) supplements. The proposed study will improve our understanding of the molecular mechanisms linking nutrition to health outcomes that are mediated by the gut microbiome.

Primary Outcome Measures: Change in gut microbiome profile, Change in gut microbiome profile, assessed using 16s RNA sequencing analysis of faecal samples provided pre and post the 6-week intervention period, 6 weeks
Secondary Outcome Measures: Change in inflammatory profile, Change in circulating markers of inflammation in serum samples collected pre and post the 6-week intervention period., 6 weeks|Changes in short chain fatty acids (SCFAs), Change in serum SCFAs measured by mass spectrometry pre and post the 4-week intervention period, 6 weeks|Wellbeing as measured by validated questionnaires, Subjective wellbeing, stress, anxiety and sleep quality assessments using validated questionnaires, 6 weeks|Changes in skin microbiome profile, Change in skin microbiome profile, assessed using 16s RNA sequencing analysis of faecal samples provided pre and post the 6-week intervention period, 6 weeks
Pneumonitis in Older Lung Cancer Patients After Radiotherapy
NCT Number: NCT06480734
Acronym: POLCAR
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Lung Cancer
Interventions: OTHER: symptom-based scoring system (symptom-questionnaire, paper version)
Sponsor: University Hospital Schleswig-Holstein
Collaborators: University of Southern Denmark|Medical School Hamburg
Sex: ALL
Age: OLDER_ADULT
Enrollment: 62
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-09-01
Completion Date: 2026-06-30
Locations: Vejle Hospital, University Hospital of Southern Denmark, Vejle, Southern Denmark, 7100, Denmark|Medical Practice for Radiotherapy and Radiation Oncology, Hannover, Lower Saxony, 30161, Germany|Medical School Hamburg, Schwerin Campus, Schwerin, Mecklenburg-Western Pomerania, 19055, Germany|Malteser Hospital St. Franziskus, Flensburg, Schleswig-Holstein, 24939, Germany|Department of Radiation Oncology, University of Lübeck and University Medical Center Schleswig-Holstein, Lubeck, Schleswig-Holstein, 23562, Germany

Summary:
The main goal of this trial is to establish the performance characteristics and to develop a decision-algorithm of a new symptom-based scoring system with respect to the identification of elderly lung cancer patients developing pneumonitis after radiotherapy.

To assess the performance characteristics of the symptom-based scoring system for detection of radiation pneumonitis the receiver operating characteristic (ROC) curve is used to show the connection between sensitivity and specificity for every possible cut-off for the symptom-based scoring system and to select the optimal scoring point for detection of radiation pneumonitis. The area under the ROC curve (AUC) is calculated to prove the diagnostic ability of the scoring system.

Secondary aims include patient satisfaction with the symptom-based scoring system (symptom-questionnaire, paper version).

Primary Outcome Measures: Number of participants with symptomatic radiation pneumonitis (grade ≥2), Radiation pneumonitis will be assessed according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0., start of radiotherapy until 24 weeks following radiotherapy
Secondary Outcome Measures: Rate of patient satisfaction, 2. Patient satisfaction with the symptom-based scoring system (symptom-questionnaire, paper version) will be assessed using a specific questionnaire., at the end of radiotherapy
Impact of Intermittent Fasting and Mediterranean Diet on the Physical Health of the Elderly
NCT Number: NCT06480669
Acronym: FASTMED
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Diabetes|Hypertension|Dyslipidemias|Obesity
Interventions: OTHER: Time Restricted Feeding|OTHER: Mediterranean Diet
Sponsor: Universidad de Zaragoza
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 17
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-01-01
Completion Date: 2024-06-04
Locations: University of Zaragoza, Zaragoza, Spain

Summary:
The prevalence of chronic diseases is increasing globally. In recent years, intermittent fasting has emerged as an effective dietary pattern against some of the most common chronic diseases in the elderly, alongside the Mediterranean diet.

The objective was to determine whether a 12-hour daily intermittent fasting regimen combined with a Mediterranean diet can improve analytical and anthropometric values in the elderly.

A total of 17 individuals of both sexes, over 60 years old, autonomous, and with preserved cognitive capacity participated. They were randomly divided into two groups: 8 people in the intervention group performed intermittent fasting along with a Mediterranean diet, and 9 in the control group adopted only a Mediterranean diet. The intervention lasted 3 months, with measurements taken at the beginning and end of the intervention.

Primary Outcome Measures: Biochemical values (mg/dL), Basal glucose, High-Density Lipoprotein, Low-Density Lipoprotein, total cholesterol, triglycerides, serum transferrin, urea, uric acid, creatinine., 12 weeks|Blood Pressure (mmHg), Blood pressure (Systolic blood pressure, diastolic blood pressure), 12 weeks|Anthropometric values (kg), Weight, 12 weeks|Anthropometric values (cm), Weight, waist circumference, hip circumference., 12 weeks|Anthropometric values (kg/m^2), Body mass index., 12 weeks|Anthropometric index (numerical rating scale), Atherogenic index of plasma, waist/hip ratio., 12 weeks|Biochemical values (IU/L), Alkaline phosphatase, aspartate aminotransferase, alanine aminotransferase, gamma-glutamyltransferase, 12 weeks|Biochemical values (mg/L), C-Reactive Protein, 12 weeks|Biochemical values (µg/L), Serum ferritin, 12 weeks|Biochemical values (µg/dL), Iron, 12 weeks|Biochemical values (g/dL), Albumin, 12 weeks
Eccentric Cycling Exercise During Pulmonary Rehabilitation Pulmonary Vascular Disease
NCT Number: NCT06480656
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Eccentric Cycling Exercise
Interventions: PROCEDURE: Rehabilitation with eccentric cycling exercise|PROCEDURE: normal rehabilitation
Sponsor: University of Zurich
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 22
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-05-29
Completion Date: 2026-07-01
Locations: Rehabilitation clinic Barmelweid, Erlinsbach, 5017, Switzerland|University Hospital Zurich, Pneumology, Zurich, Switzerland

Summary:
Eccentric cycling allows high intensities with low metabolic costs. Therefore the aim of this project is to investigate whether ECC improves exercise capacity and possibly hemodynamics during prolonged rehabilitation programs in patients with PVD

Primary Outcome Measures: peak exercise capacity, 3 weeks
Secondary Outcome Measures: Peak oxygen uptake, Assesses during exercise until exhaustion using an incremental exercise protocol, 3 weeks|ventilatory equivalent for CO2, 3 weeks|Finger pulseoximetry, Arterial oxygen saturation will be assessed by finger clip Infrared spectroscopy, 3 weeks|6 minute walk distance, 3 weeks|systolic pulmonary artery pressure, 3 weeks|total pulmonary resistance, 3 weeks|ventricular - pulmonary arterial coupling, 3 weeks|cardiac output, will be assessed by echocardiography using the pulse-wave doppler technique at the left ventricular outflow tract durig systole., 3 weeks|Arterial partial pressure for oxygen, Arterial blood gas analyses, taken from the radial artery and analysed by radiometer, 3 weeks|Arterial partial pressure for carbon dioxide, Arterial blood gas analyses, taken from the radial artery and analysed by radiometer, 3 weeks|Arterial oxygen saturation, Arterial blood gas analyses, taken from the radial artery and analysed by radiometer, 3 weeks|Arterial lactate concentration, Arterial blood gas analyses, taken from the radial artery and analysed by radiometer, 3 weeks|Borg CR 10 for perceived dyspnea, 3 weeks|Borg CR 10 for perceived leg fatigue, 3 weeks|Visual analogue scale generell well being, 3 weeks|Visual analogue scale dyspnea, 3 weeks
Observational, Bivariate Analysis of Clinical Big Data in Patients With Cervical Cancer
NCT Number: NCT06480617
Status: ACTIVE_NOT_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Progression-free Survival Was Defined From Date of Surgery to Disease Progression Post-surgery or Death or Last Follow-up|Overall Survival Was Defined as Time From Surgery to Death From Any Cause or Last Follow-up
Sponsor: Anhui Provincial Hospital
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 3000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-10-31
Completion Date: 2027-12-31
Locations: Anhui Provincal Hospital, Hefei, Anhui, 230001, China

Summary:
This is a large non-interventional observational bidirectional study planned to collect clinically relevant data and prognostic follow-up information of patients with cervical cancer who were seen at our center from 2010.01.01 to the end of this study.

Primary Outcome Measures: progression-free survival, 5 years
Secondary Outcome Measures: overall survival, 5 years
Evaluation of the Pathobiology of CALR-mutated MPN Cells
NCT Number: NCT06480591
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Myeloproliferative Neoplasm
Interventions: OTHER: Blood Draw
Sponsor: Wake Forest University Health Sciences
Collaborators: Atrium Health Levine Cancer Institute|Brookdale University Hospital Medical Center
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 35
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09
Completion Date: 2026-02
Locations: Atrium Health Levine Cancer, Charlotte, North Carolina, 28204, United States

Summary:
The purpose of this study is to understand why there is a greater risk of thrombosis in patients who have the JAK2 mutation as compared to those with CALR mutations.

Primary Outcome Measures: Expression levels of TLR 2 and TLR 4, Percentages of mononuclear cells expressing TLR 2 and TLR 4 will be calculated for each participant., 24 months
Secondary Outcome Measures: Plasma levels of inflammatory cytokines, Presence and levels of inflammatory cytokines, IFN-γ, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12p70, IL-13, and TNF-α, will be recorded by multiplex Elisa for each participant., 24 months|Plasma levels of inflammatory cytokines following incorporation of TLR ligands, Presence and levels of inflammatory cytokines, IFN-γ, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12p70, IL-13, and TNF-α, will be calculated for each participant using the in vitro cell culture system., 24 months|History of thrombosis, Determined for each participant as a binary variable indicating whether this participant had history of thrombosis., 24 months
A Phase 1/2 Trial of ADI-270 in ccRCC
NCT Number: NCT06480565
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Clear Cell Renal Cell Carcinoma
Interventions: DRUG: ADI-270|DRUG: Fludarabine|DRUG: Cyclophosphamide
Sponsor: Adicet Therapeutics
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2027-06

Summary:
This is a Phase 1/2 multicenter, open-label, dose escalation, and dose expansion study of ADI-270 - an Engineered gamma-delta Chimeric Receptor \[CAR\] Vδ1 T Cell product Targeting CD70 - in patients with R/R ccRCC.

Primary Outcome Measures: The Incidence of Subjects with Dose Limiting Toxicities within each dose level cohort, This primary endpoint will be used to determine the Maximum Tolerated Dose (MTD) or Maximum Assessed dose (MAD), Day 28|Proportion of treatment emergent and treatment related adverse events, This primary endpoint will be used to determine the MTD/MAD of ADI-270, 2 years
A Trial to Evaluate Safety and Efficacy of a Product Named VGN-R09b in Patients With Parkinson's Disease
NCT Number: NCT06480461
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Parkinson's Disease
Interventions: DRUG: VGN-R09b
Sponsor: Shanghai Vitalgen BioPharma Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 39
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-01
Completion Date: 2031-07-01

Summary:
A phase Ⅰ/Ⅱ study to evaluate the tolerability, safety, and efficacy of VGN-R09b in pa-tients with Parkinson's disease

Primary Outcome Measures: Number of Adverse Events (AEs), Serious Adverse Events (SAEs)Vital signs, Vital signs, physical examination, laboratory test will be monitored after drug injection, up to Week 52
Secondary Outcome Measures: Changes in clinical outcomes, Subject number of MDS-Unified Parkinson's Disease Rating Scale Part I, II, III, and IV (UPDRS III) scores in ON- and OFF state；, up to Week 52|Changes in clinical outcomes, Subject number of Levodopa equivalent daily dose (LEDD)；, up to Week 52|Immunogenicity after injection, Subject number with positive antibodies of AAV9/AADC/Glial Cell Line-Derived Neurotrophic Factor (GDNF) in blood would be reported, up to 52 weeks
Treadmill Training Effects on Cardiorespiratory Endurance and Constipation in Children With Cerebral Palsy
NCT Number: NCT06480448
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cardiopulmonary
Interventions: OTHER: Traditional physical herapy|OTHER: Treadmill training
Sponsor: Riphah International University
Sex: ALL
Age: CHILD
Enrollment: 36
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-04-28
Completion Date: 2024-12-31
Locations: Rehman Medical Institute, Peshawar, Punjab, 46000, Pakistan

Summary:
This study examines the impact of treadmill training on cardiorespiratory endurance and constipation in children with cerebral palsy (CP). Treadmill training is evaluated for its potential to improve cardiovascular fitness and alleviate constipation through its rhythmic movements. The findings shed light on the broader health benefits of treadmill interventions beyond motor function improvement in children with CP

Primary Outcome Measures: Constipation Assessment Scale (CAS), One commonly used tool for assessing constipation in children is the "Rome IV Criteria," which is part of the Rome IV diagnostic criteria for functional gastrointestinal disorders. These criteria provide a standardized framework for diagnosing constipation based on specific symptoms and duration requirements, Baseline - 12th Week|6-mintues walk test, The 6-Minute Walk Test (6MWT) is a standardized assessment used to measure a person's functional exercise capacity and endurance. During the test, individuals are instructed to walk as far as they can within a six-minute period along a flat, straight course. The test is typically conducted in a corridor or along a marked pathway, and the distance covered is recorded at the end of the test.

Before the test begins, participants receive instructions on the procedure and are given the opportunity to ask questions. Baseline measurements such as heart rate, blood pressure, and oxygen saturation may be taken. Participants are encouraged to walk at a self-selected pace, and they are allowed to rest if needed during the test. However, the timer continues to run during rest periods., Baseline - 12th Week|Heart Rate, The number of pulses over a minute is the standard heart rate measurement. This can also be calculated by doubling the number of pulses felt over 30 seconds., Baseline - 12th Week|VO2 Max, VO2 max, or maximal oxygen consumption, refers to the maximum amount of oxygen that an individual can utilize during intense or maximal exercise. This measurement is generally considered the best indicator of cardiovascular fitness and aerobic endurance., Baseline - 12th Week|Respiratory Rate, Baseline - 12th Week
Combined Effects Of Autogenic Drainage and Segmental Breathing Techniques in Chronic Obstructive Pulmonary Disease
NCT Number: NCT06480422
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Chronic Obstructive Pulmonary Disease
Interventions: OTHER: Segmental breathing technique|OTHER: autogenic drainage
Sponsor: Riphah International University
Sex: ALL
Age: ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-01-15
Completion Date: 2024-09-15
Locations: Ever Care Hospital, Lahore, Punjab, 54000, Pakistan

Summary:
Chronic obstructive pulmonary disease is one of the most common life threatening disease affecting population. It is a preventable and treatable lung disease. People with COPD must work harder to breathe, which can lead to shortness of breath and/or feeling tired. Autogenic drainage (AD) works by adapting your breathing and maximizing airflow within the airways to improve ventilation and clear sputum. Segmental breathing, also referred to as localized expansion breathing, is the exercise used to improve ventilation and oxygenation. This research of randomized controlled trial will check the combined effects of segmental breathing technique and autogenic drainage technique in chronic obstructive pulmonary disease by taking sample of 40 patients through non probability convenient sampling and randomly allocating them into two groups A and B out of which A will receive both autogenic drainage and segmental breathing technique, B will receive autogenic drainage only for upto the duration of 3 days per week(20-45 min) for upto 4 weeks.Pre and post training outcomes will be measured through pulse oximeter,spirometer and BCSS.The data will be analyzed through SPSS 25.

Primary Outcome Measures: SPIROMETER, The most used pulmonary function test is spirometry. It assesses the capacity of the lungs to breathe in and out, especially the volume and/or velocity of air that can be expelled. When evaluating breathing patterns to detect diseases including asthma, pulmonary fibrosis, cystic fibrosis, and COPD, spirometry is useful. An FEV1/FVC ratio larger than 0.70 with both FEV1 and FVC over 80% of the expected value are considered normal spirometry data. TLC exceeding 80% of the predicted value is typical in the event that lung volumes are measured. Diffusion capacity that is more than 75% of the expected value is likewise regarded as typical, baseline and fourth week|PULSE OXIMETER, Pulse oximetry operates by shining a light through the skin at two different wavelengths_660 nm(red) and 940nm(infrared)_ and measuring the difference in light absorbance at the two wavelengths to estimate an arterial oxygen saturation, baseline and fourth week|BREATHLESSNESS COUGH SPUTUM SCALE(BCSS), The breathlessness cough sputum scale tool is an effective means for measuring the impact of Pulmonary rehabilitation on improving patient tolerance and self reported symptoms as the result of COPD, baseline and fourth week
**Virtual Reality in Student Mental Health: Solution or White Elephant?**
NCT Number: NCT06480409
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Mental Health Issue
Interventions: OTHER: VR Mindfulness and Stress Reduction Program
Sponsor: The Opole University of Technology
Sex: ALL
Age: ADULT
Enrollment: 50
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2023-06-05
Completion Date: 2024-06-05
Locations: Faculty of Physical Education and Physiotherapy, Opole University of Technology, Opole, 45-758, Poland

Summary:
The COVID-19 pandemic drastically altered social structures, leading to prolonged isolation and remote learning for students, causing significant mental health issues. This project at Opole University of Technology aims to address these challenges through a virtual reality (VR)-based therapeutic program.

Objectives:

The project will utilize immersive VR technology to conduct relaxation sessions, creating a dedicated relaxation room equipped with VR headsets and physiological sensors. The goal is to assess the impact of VR-based therapy on students' autonomic nervous system and psychological well-being.

Key Hypotheses:

VR relaxation sessions will induce physiological relaxation. A 15-minute VR session will not cause cybersickness. Weekly VR sessions will reduce stress levels among students.

Methodology:

Using Polar H-10 sensors, the project will measure heart rate variability (HRV) to evaluate autonomic responses. Psychological stress will be monitored using the Perceived Stress Scale (PSS-10). A sample size of 50 participants, calculated with G\*Power software, will be studied using repeated measures ANOVA.

Primary Outcome Measures: Physiological Relaxation, Participants will be monitored via heart rate variability (HRV) indicating a balanced autonomic nervous system response., 20 min|Stress Levels, Participants will be examined by the Perceived Stress Scale (PSS-10)., 10 min
High Versus Lower Intensity Surveillance Following Resection of Retroperitoneal Sarcoma
NCT Number: NCT06480396
Acronym: SARveillance
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Sarcoma,Soft Tissue|Sarcoma Retroperitoneal
Interventions: DIAGNOSTIC_TEST: High-intensity radiological surveillance|DIAGNOSTIC_TEST: Lower-intensity radiological surveillance
Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Collaborators: University of Birmingham|University Hospital Birmingham NHS Foundation Trust|Royal Marsden NHS Foundation Trust|University Hospital Padova|Campus Bio-Medico University|The Netherlands Cancer Institute|KU Leuven|Heidelberg University|Dana-Farber/Brigham and Women's Cancer Center|Emory University|Mayo Clinic|Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium|The Cleveland Clinic|M.D. Anderson Cancer Center|University of Southern California|Ohio State University|Ottawa Hospital Research Institute|McGill University|Peter MacCallum Cancer Centre, Australia|Royal Prince Alfred Hospital, Sydney, Australia
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 584
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-08
Completion Date: 2033-12
Locations: Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Lombardia, 20133, Italy|University Hospitals Birmingham NHS Foundation Trust, Birmingham, West Midlands, B15 2GW, United Kingdom

Summary:
The SARveillance trial is an efficient, pragmatic, multi-centre, international, stratified, partially-randomised, patient-preference trial within a registry of high versus lower intensity radiological surveillance following primary resection of retroperitoneal, abdominal and pelvic soft tissue sarcoma. The trial design is stratified by sarcoma tumour grade (high/intermediate grade and low grade).

Primary Outcome Measures: Emotional Functioning, Quality of life, assessed using Emotional Functioning domain of the EORTC QLQ-C30, 5 years
Secondary Outcome Measures: Overall survival, From time of primary surgery to death (all-cause mortality) or last follow up, 5 years|Cancer worry scale, Four cancer specific questions from the EORTC Library, 5 years|Health utility, EuroQol Group EQ-5D-5L, 5 years
Other Outcome Measures: Disease free survival, Defined as time from primary surgery to radiological evidence of disease recurrence as defined by the revised-RECIST criteria, (48, 49) by definition will be decreased in the high intensity follow-up group. This will be adopted as a process measure rather than an outcome measure., 5 years
Optimization of Transcranial Motor Evoked Potentials in Supratentorial Surgeries
NCT Number: NCT06480370
Acronym: MEPO
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Surgery
Interventions: DEVICE: ISIS IOM System
Sponsor: Insel Gruppe AG, University Hospital Bern
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 203
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07
Completion Date: 2027-12

Summary:
This project aims to optimize the methodology to elicite transcranial motor evoked potentials in intraoperative neurophysiological monitoring of brain surgery. It includes accelerometer measurements and microscope video image to determine movement of the surgical field, making possible minimization of movement during brain stimulation.

Primary Outcome Measures: threshold of stimulation and patient movement, threshold of stimulation and patient movement quantified by an accelerometer placed on the forehead of the patient, during surgery
Secondary Outcome Measures: patient movement, patient movement quantified by an accelerometer on the shoulder, during surgery|subjective evaluation of magnitude of motion, subjective evaluation by the surgeon of magnitude of motion using post-processing of digital images from the surgical microscope, end of surgery|quantification of magnitude, quantification of magnitude of motion using post-processing of digital images from the surgical microscope, end of surgery
A Giant Myelolipoma.
NCT Number: NCT06480357
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Adrenal Myelolipoma
Interventions: PROCEDURE: laparoscopic adrenalectomy
Sponsor: Instituto Mexicano del Seguro Social
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 1
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-24
Completion Date: 2024-06-24
Locations: Mexican Institute Of Social Health, Mérida, Yucatán, 92227, Mexico

Summary:
48-year-old woman who presented with intermittent left flank pain with incidental findings of adrenal tumor on computed tomography (CT). She underwent laparoscopic tumor resection due to a large tumor of 12 cm in size.

Primary Outcome Measures: Cure of the disease, Complete myelolipoma resection, 3 days
Analysis of Risk Factors for Surgical Site Infections in Patients With Acute Abdomen at Hospital of State University of Haiti
NCT Number: NCT06480344
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Surgical Site Infection|Post-Op Infection
Sponsor: University of Haiti
Collaborators: Christopher Williams Valsaint|Axler Jean-Paul
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 87
Study Design: Observational Model: |Time Perspective: p
Start Date: 2021-03-01
Completion Date: 2021-08-30
Locations: Hopital de l'Université d'Etat d'Haiti, Port-au-Prince, Ouest, Haiti

Summary:
The purpose of this study is to identify the risk factors associated with surgical site infection.

Primary Outcome Measures: Occurence of surgical site infection, Wheter or not patients developed surgical site infection, 1 year
Radiation Free Fistuloplasty is the Way Forward
NCT Number: NCT06480331
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Fistulas Arteriovenous
Interventions: PROCEDURE: Ultrasound-guided fistuloplasty|PROCEDURE: Fluoroscopy-guided fistuloplasty
Sponsor: University of Malaya
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 54
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-07-01
Completion Date: 2024-12-31
Locations: Kuala Lumpur Hospital, Jalan Pahang,, Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur, 50586, Malaysia|University Malaya Medical Centre, Jln Profesor Diraja Ungku Aziz, Seksyen 13,, Petaling Jaya, Wilayah Persekutuan Kuala Lumpur, 50603, Malaysia

Summary:
The goal of this clinical trial is to study effectiveness of ultrasound-guided fistuloplasty in comparison to conventional fistuloplasty in patients with arteriovenous access flow dysfunction. The main question it aims to answer is:

To investigate patencies in patients with arteriovenous access flow dysfunction receiving ultrasound-guided fistuloplasty versus fluoroscopy-guided fistuloplasty at 6 months

Participants will:

* be randomized equally to ultrasound-guided fistuloplasty group and fluoroscopy-guided fistuloplasty group.
* visit clinic at one month, three month \& six months for checkups and tests.

Primary Outcome Measures: To investigate patencies in patients with arteriovenous access flow dysfunction receiving ultrasound-guided fistuloplasty versus fluoroscopy-guided fistuloplasty at 6 months, The duration of time from intervention to thrombosis or any re-intervention to facilitate, maintain, or re-establish patency, 6 months
Secondary Outcome Measures: To capture data regarding variables that may affect patency of arteriovenous access flow dysfunction post ultrasound-guided fistuloplasty versus fluoroscopy-guided fistuloplasty, These includes demographic data (comorbidities, smoking history, gender, patient's age, age of fistula) and anatomic location of lesion and number of lesion., Over the course of six months follow-up|To compare technical success in patients with arteriovenous access flow dysfunction receiving ultrasound-guided fistuloplasty versus fluoroscopy-guided fistuloplasty, Technical success is defined as clinical palpable thrill, radiographic finding of less than 30% recoil and ultrasonographic finding of continuous segment of dilated vein to 5-6mm and continuous flow rate of more than 500ml/min, Immediately post operation|To compare complication rates in patients with arteriovenous access flow dysfunction receiving ultrasound-guided fistuloplasty versus fluoroscopy-guided fistuloplasty, This includes thrombosis, pseudoaneurysm and bleeding, Immediately post operation
Effect of TENS of Intestınal Functıons, Pain and Analgesis Consumptıon Amount
NCT Number: NCT06480318
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Colorectal Surgery|Pain, Postoperative
Interventions: DEVICE: TENS
Sponsor: İlknur tura
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 70
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (INVESTIGATOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-09-01
Completion Date: 2025-07-05

Summary:
In this study, the effect of TENS applied to patients undergoing open colorectal surgery on bowel functions, pain and analgesia consumption amount will be evaluated.

Primary Outcome Measures: Primary Outcome Measure, The patient will be monitored until the 48th hour after surgery. 11th and 12th in the standard care and TENS group; 23rd and 24th; Pain assessment will be made with a numerical pain scale a total of 8 times at the 35th and 36th hours, and at the 47th and 48th hours.

In the TENS group, at the 11th hour (just before TENS), at the 12th hour (1 hour after TENS), At the 23rd hour (just before TENS), at the 24th hour (1 hour after TENS), At 35th hour (just before TENS), at 36th hour (1 hour after TENS), Pain will be re-evaluated at the 47th hour (just before TENS) and at the 48th hour (1 hour after TENS).

Intestinal functions of both groups will be questioned and recorded during each procedure.

TENS will not be applied to the standard care group. In the TENS group, 11.,-23.,-35.,-47. TENS will be applied a total of 4 times for 20 minutes between hours.

Patients' pain is expected to score at most 2-3 on a scale of 0-10., 48 hours
Telerehabilitation Exercise: Effects on Maternal Quality of Life, Fetal and Neonatal Health.
NCT Number: NCT06480292
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Gestational Diabetes Mellitus in Pregnancy
Interventions: OTHER: telerehabilitation exercise|OTHER: routine medical care
Sponsor: Riphah International University
Sex: FEMALE
Age: ADULT
Enrollment: 62
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-01
Completion Date: 2025-02-28
Locations: Pakistan Railways Hospital, Rawalpindi, Punjab, 44000, Pakistan|AlKhidmat Razi Hospital,Rawalpindi, Rawalpindi, Punjab, 46000, Pakistan

Summary:
Gestational diabetes mellitus (GDM) occurs when blood sugar levels rise during pregnancy, typically between 24-28 weeks, affecting about 2-18% of all pregnancies. It is a common metabolic disease that can lead to health risks for the mother, fetus, and child, and can negatively impact the mother's quality of life. This study aims to explore how a telerehabilitation exercise program affects the quality of life of mothers with GDM and the health of fetus/neonate.

Primary Outcome Measures: GDMQ-36 for Maternal Quality of Life, The GDMQ (Gestational Diabetes Mellitus Quality of Life)-36 is a simple, valid, and reliable tool for assessing the quality of life of women with GDM across five domains: Emotional, Physical, Social, Self-Efficacy, and Healthcare. Each domain includes multiple items rated on a 5-point Likert scale (strongly agree to strongly disagree) with a score range of 1 to 5. Domain scores are calculated by summing the responses for each item, and the total GDMQ score is the sum of all domain scores. Higher scores generally indicate better quality of life if the scale is positively oriented. This tool helps identify areas needing intervention and support, offering a comprehensive measure of GDM-related quality of life., changes from baseline to 8th week
Secondary Outcome Measures: Fetal Health, Fetal Health measured by fetal obstetric ultrasound and anomaly scan., changes from baseline to 8th week|Neonatal Health, Neonatal outcome measured by examination and pediatric records., At the time of delivery
Influence of Protein Intake on Muscle Mass and Health-related Quality of Life During and After Radiotherapy
NCT Number: NCT06480266
Acronym: pROtein
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Malnutrition; Cachexia
Sponsor: Charite University, Berlin, Germany
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 175
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-15
Completion Date: 2026-01-31
Locations: Charité University Medicine Berlin, Berlin, 13353, Germany

Summary:
The influence of radiotherapy on the protein intake and muscle mass of patients has not been extensively investigated to date. It is also unclear whether the localization of the tumor disease and thus the radiation field have different effects. Therefore, with the pilot study presented here, we would like to record the nutritional uptake of patients before and after radiotherapy. The aim is to determine the amount of energy and protein intake as well as the timing of protein intake. Furthermore, the relationship between the timing of protein intake and muscle mass will be investigated.

Primary Outcome Measures: Protein uptake in g/kg body weight, Change in the amount of protein consumed and its distribution over the main meals by means of a dietary questionnaire before, at the end and 3 months after completion of radiotherapy., baseline, end of radiotherapy and 3 months after Radiotherapy
Secondary Outcome Measures: Weight in kg, Body Weight, baseline, end of radiotherapy and 3 months after Radiotherapy|Muscle mass in kg, Evaluation of Muscle mass via Bioimpedance Measurements, baseline, end of radiotherapy and 3 months after Radiotherapy|Quality of Life (EORTC QLQ C30) in 5-tier likert scale (higher scores = better), Health Related Quality of Life with EORTC QLQ C30, baseline, end of radiotherapy and 3 months after Radiotherapy|Height in m, Height, baseline, end of radiotherapy and 3 months after Radiotherapy|Fatigue in 5-tier likert scale (higher scores = worse), FACIT F Questionnaire, baseline, end of radiotherapy and 3 months after Radiotherapy|BMI in kg/m², BMI calculated from weight and Hight, baseline, end of radiotherapy and 3 months after Radiotherapy|Treatment Toxicity via CTCA criteria (5 tier scale; higher = worse), Common Terminology Criteria for Adverse Events (CTCAE) version 5, baseline, weekly during radiotherapy, end of treatment, follow up (up to 1 year, on average every 3 months)|Treatment Toxicity via PROMs (5 tier scale; higher = worse), Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE®), baseline, weekly during radiotherapy, end of treatment, follow up (up to 1 year, on average every 3 months)
Cerebral Blood Flow: Helmet vs Oronasal Mask During Continuous Positive Airway Pressure Ventilation
NCT Number: NCT06480253
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Ventilation Therapy
Interventions: DEVICE: Helmet Continuous Positive Airway Pressure|DEVICE: Oronasal Mask Continuous Positive Airway Pressure
Sponsor: Papa Giovanni XXIII Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 19
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-01
Completion Date: 2024-07-31
Locations: Ospedale Papa Giovanni XXIII, Bergamo, 24127, Italy

Summary:
In this trial the investigators will evaluate blood flow in common carotid artery of healthy subjects treated with Continuous Positive Airway Pressure (CPAP) Ventilation, comparing two different devices: oronasal mask versus Helmet. The hypothesis is that Helmet CPAP reduces carotid flow compared to oronasal mask.

Primary Outcome Measures: Common carotid artery flow, Left common carotid artery flow, expressed as ml/min measured with pulsed wave doppler with ultrasound, 4 consecutive heart beats at the end of the intervention
Secondary Outcome Measures: Mean arterial blood pressure, Non invasive mean arterial blood pressure on left arm, single measure, at the end of the intervention|Peripheral vascular resistance, Peripheral vascular resistance measured in left common carotid artery, measured with pulsed wave doppler with ultrasound, 4 consecutive heart beats at the end of the intervention