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Aims: To compare the efficacy and safety of a SCD versus MCD on glycemic control, metabolomic signatures, and pregnancy outcomes in pregnant individuals on IIT. conditions: Diabetes in Pregnancy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Open label, randomized controlled trial primaryPurpose: TREATMENT masking: NONE count: 120 type: ESTIMATED name: Nutritional intervention measure: Time in range measure: Time above range sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT hasResults: False
<|newrecord|> nctId: NCT06355141 id: E-15189967-050.04-494458 briefTitle: Oral Structural and Functional Problems in Children With Autism overallStatus: NOT_YET_RECRUITING date: 2024-04-11 date: 2024-05-13 date: 2024-08-12 date: 2024-04-09 date: 2024-04-09 name: Hacettepe University class: OTHER briefSummary: This study aims to examine oral structural and functional problems in children with autism. conditions: Autism Spectrum Disorder conditions: Chewing Problem conditions: Drooling studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 90 type: ESTIMATED name: oral assessment measure: Demographic Information Form measure: Time to achieve Oromotor skills measure: Oral structural assessment measure: Chewing evaluation measure: Drooling of saliva evaluation measure: Tongue thrust evaluation sex: ALL minimumAge: 5 Years maximumAge: 15 Years stdAges: CHILD hasResults: False
<|newrecord|> nctId: NCT06355128 id: 20240307 briefTitle: A Cross-sectional Study of Ocular Manifestations During the Covid-19 Pandemic in Hubei Province overallStatus: ACTIVE_NOT_RECRUITING date: 2024-01-01 date: 2024-02-18 date: 2024-04-30 date: 2024-04-09 date: 2024-04-09 name: Zhongnan Hospital class: OTHER name: Qichun People's Hospital briefSummary: To investigate the clinical features of ocular manifestations during the novel coronavirus pneumonia pandemic in Hubei at the end of 2022 conditions: COVID-19 conditions: Ocular Surface Disease studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 16000 type: ACTUAL name: NOT measure: Questionnaire data were collected and statistically analyzed. sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Zhongnan Hospital of Wuhan University city: Wuhan state: Hubei zip: 430071 country: China lat: 30.58333 lon: 114.26667 hasResults: False
<|newrecord|> nctId: NCT06355115 id: 400/218/K.3/302/2023 briefTitle: Prophylactic Antibiotics Duration Towards Healing and Risk of Infection in Permanent Pacemaker (PPM) Installation acronym: PACE-PRO overallStatus: RECRUITING date: 2023-09-01 date: 2024-09-01 date: 2024-09-01 date: 2024-04-09 date: 2024-04-09 name: University of Brawijaya class: OTHER name: Saiful Anwar Hospital briefSummary: The insertion of a permanent pacemaker (PPM) is frequently a life-saving procedure. However, the implantation process could sometimes lead to a rare but serious infection. Therefore, administering prophylactic antibiotics to prevent infections before they occur, is a useful strategy to lower the risk of such infections.
Nonetheless, the optimal duration of prophylactic antibiotics for PPM remains uncertain. Individual study results are ambiguous and debatable due to the fact that each center has its own policy governing the regimen for prophylactic antibiotic use. Accordingly, the goal of this clinical trial is to assess and compare the effectiveness of two types of widely used prophylactic antibiotic durations in relation to the risk of infections following PPM implantations.
The main questions it aims to answer are:
1. What is the efficacy of different durations of prophylactic antibiotics (single dosage vs 3-day dosage) in preventing infective complications following PPM implantations?
2. What factors may influence the optimum use of prophylactic antibiotics for individual patients undergoing PPM implantation to minimize the risk of infective complications?
Researchers will compare a single dosage vs a 3-day dosage of prophylactic antibiotics following the PPM implantation procedure to see the risk of device-related infections.
Participants will:
* Be given a single-dose or 3-days dose of antibiotic regarding the PPM installations.
* Visit the clinic for follow-ups and tests. conditions: Pacemaker Complication studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 100 type: ESTIMATED name: Cefazolin 1000 MG Injection measure: Number of participants with early pocket infection (EPI) measure: Number of participants with late pocket infection (LPI) measure: Number of participants with infective endocarditis (IE) measure: Number of participants who underwent pacemaker revision measure: Level of C-reactive protein (mg/dl) measure: Level of procalcitonin (mcg/dl) measure: Erythrocyte sedimentation rate (ESR) (mm/hour) measure: Neutrophil-to-leukocyte ratio (NLR) measure: Neutrophil count (cells/mm3) measure: Leukocyte count (cells/mm3) sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: RSUD Dr. Saiful Anwar status: RECRUITING city: Malang state: Jawa Timur zip: 65112 country: Indonesia name: RSUD Dr. Saiful Anwar role: CONTACT phone: 0341-362101 email: [email protected] lat: -7.9797 lon: 112.6304 hasResults: False
<|newrecord|> nctId: NCT06355102 id: 2024-SR-116 briefTitle: The Development of Tinnitus in Patients With SSNHL: Insights From fMRI and Metabolomics overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2025-12-31 date: 2026-03-31 date: 2024-04-09 date: 2024-04-09 name: The First Affiliated Hospital with Nanjing Medical University class: OTHER briefSummary: The goal of this clinical trial is to investigate the factors and mechanisms underlying tinnitus generation and chronification in patients with sudden sensorineural hearing loss (SSNHL) . The main questions it aims to answer are:
* What are the peripheral and central influencing factors that contribute to tinnitus in patients with SSNHL?
* Can serum metabolic biomarkers be identified to predict and monitor tinnitus prognosis in these patients?
Participants in this study will include patients with SSNHL and tinnitus, patients with SSNHL without tinnitus, and healthy subjects. They will be asked to undergo a series of assessments, including audiological tests, vestibular function examinations, and functional magnetic resonance imaging (fMRI). Additionally, blood samples will be collected for metabolomics analysis.
Investigators will compare the brain functional states and serum metabolite profiles of patients with SSNHL and tinnitus to those without tinnitus. Morever, tinnitus symptom characteristics, audiological outcomes, and brain functional states will be assessed during time. conditions: Sudden Sensorineural Hearing Loss conditions: Tinnitus studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 90 type: ESTIMATED measure: Brain function states measure: Serum metabolomics sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<|newrecord|> nctId: NCT06355089 id: VAR-MIKRO briefTitle: Intestinal Microbiota: Immunity, Recovery and Metabolic Health acronym: VAR-MIKRO overallStatus: COMPLETED date: 2023-01-09 date: 2023-09-07 date: 2023-09-07 date: 2024-04-09 date: 2024-04-09 name: University of Turku class: OTHER name: Government Body Funding briefSummary: The aim of this intervention study is to investigate the effect of a specific postbiotic (Lacticaseibacillus rhamnosus GG = LGG) and whey protein on immunity, recovery, and weight management in young adults. The objective is based on previous knowledge about the health-promoting effects of these factors. A new goal is to study the combined effect of the postbiotic and whey protein. The results of the study can be utilized to promote the health of the young adults. conditions: Healthy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 160 type: ACTUAL name: Placebo Comparator name: Whey protein hydrolysate milk product name: Postbiotic and whey protein hydrolysate milk product measure: Concentrations of inflammatory markers from the blood samples measure: Gut microbiota composition in feces measure: Weight of the participant measure: Waist circumference of the participant measure: Infections during the intervention measure: Development of physical fitness measure: Sleep quality measure: Recovery measure: Blood pressure measure: BMI sex: ALL minimumAge: 17 Years maximumAge: 28 Years stdAges: CHILD stdAges: ADULT facility: University of Turku city: Turku country: Finland lat: 60.45148 lon: 22.26869 hasResults: False
<|newrecord|> nctId: NCT06355076 id: CSZ03 briefTitle: New Urethral Reconstruction in Robot-assisted Laparoscopic Radical Resection overallStatus: RECRUITING date: 2023-02-05 date: 2026-06 date: 2026-06 date: 2024-04-09 date: 2024-04-09 name: Qilu Hospital of Shandong University class: OTHER briefSummary: The purpose of this clinical trial is to compare new reconstruction and anastomosis in robot-assisted radical laparoscopic resection It will also understand the possibility of exploring new reconstruction in completely solving patients' postoperative urinary incontinence The main questions it aims to answer are:
Is there a significant improvement in urinary control in patients with new reconstruction compared with patients with anastomosis? The researchers compared the new reconstruction with anastomosis in robot-assisted laparoscopic radical resection to see if the new reconstruction improved urinary incontinence after operation.
Participants will:
The intervention group adopted the new reconstruction proposed by our team; End-to-end anastomosis was performed in non-intervention group. conditions: Prostate Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The experimental group received a new urethral reconstruction technique, which involves suturing the levator ani muscle with the lateral striated muscle of the urethra, the dorsal median ridge (MDR), and the Di's fascia together for continuous suturing before performing bladder urethral anastomosis. After the reconstruction is completed, the end to end anastomosis of the bladder urethra is performed primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Patients in the experimental or control group, as well as their family members, are unaware whoMasked: PARTICIPANT count: 94 type: ESTIMATED name: New urethral reconstruction measure: Recovery of urinary incontinence measure: complication measure: PSA measure: recurrence sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Qilu hospital status: RECRUITING city: Jinan state: Shandong zip: 276600 country: China name: shouzhen chen role: CONTACT phone: 18560089085 email: [email protected] lat: 36.66833 lon: 116.99722 hasResults: False
<|newrecord|> nctId: NCT06355063 id: NP-PCF-037 briefTitle: CellFX® nsPFA™ Cardiac Surgery System to Treat Atrial Fibrillation overallStatus: NOT_YET_RECRUITING date: 2024-05-15 date: 2025-08-31 date: 2025-10-31 date: 2024-04-09 date: 2024-04-09 name: Pulse Biosciences, Inc. class: INDUSTRY briefSummary: This feasibility study will be conducted to demonstrate the initial safety and effectiveness of the CellFX® nsPFA™ Cardiac Clamp in performing a box lesion around the 4 pulmonary veins as an isolated procedure or as a part of a more extensive surgical ablation set in conjunction with concomitant cardiac surgical procedure. conditions: Atrial Fibrillation conditions: Surgery studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: This study is a prospective, multicenter, single arm, non-randomized, feasibility study. primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: CellFX® nsPFA™ Cardiac Surgery System measure: Rate of acute major adverse events (MAEs) measure: Number of Participants with acute electrical isolation of the bilateral pulmonary veins and left atrial free wall. measure: Proportion of Participants with one or more SAEs measure: Number of Participants with Long-Term Technical Success sex: ALL minimumAge: 22 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Academic Medical Center city: Amsterdam country: Netherlands lat: 52.37403 lon: 4.88969 facility: Maastricht University Medical Center city: Maastricht country: Netherlands lat: 50.84833 lon: 5.68889 facility: St. Antonius Hospital city: Nieuwegein country: Netherlands lat: 52.02917 lon: 5.08056 hasResults: False
<|newrecord|> nctId: NCT06355050 id: UKJ-ultraHART briefTitle: Ultrahypofractionated, Adaptive Radiation Therapy of Prostate Cancer acronym: ultraHART overallStatus: NOT_YET_RECRUITING date: 2024-06-30 date: 2026-09-30 date: 2031-09-30 date: 2024-04-09 date: 2024-04-09 name: Jena University Hospital class: OTHER name: University Hospital Schleswig-Holstein name: Klinikum Stuttgart briefSummary: In this prospective, multi-center cohort study, the tolerability and quality of life during ultrahypofractionated radiotherapy (RT) of early stage prostate cancer is surveyed at several institutions in Germany. Radiotherapy is delivered with by an online-adaptive RT device (Varian Ethos), which is able to correct daily variations in anatomy and to adjust the irradiation plan accordingly. A digital patient questionnaire is used to asses quality of life longitudinally. Quality of life (QoL) and toxicity profiles will be correlated with planning parameters and compared to retrospective cohorts of patients who underwent normofractionated RT or moderately hypofractionated RT, respectively. conditions: Prostate Cancer conditions: Adaptive Radiotherapy conditions: Quality of Life studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED measure: Toxicity (CTCAE v5.0) measure: Quality of Life (EPIC 26) measure: Planning parameters measure: Dose constraints measure: Conformity indices measure: Quality of adaptive planning measure: PSA-value measure: Overall survival measure: Recurrence free survival sex: MALE minimumAge: 18 Years maximumAge: 120 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Radiotherapy and Radiation Oncology, Jena University Hospital city: Jena country: Germany name: Klaus Pietschmann, MD role: CONTACT email: [email protected] name: Georg Wurschi, MD role: PRINCIPAL_INVESTIGATOR lat: 50.92878 lon: 11.5899 hasResults: False
<|newrecord|> nctId: NCT06355037 id: B2024.1.30 briefTitle: Dasatinib Combined With Quercetin to Reverse Chemo Resistance in Triple Negative Breast Cancer overallStatus: NOT_YET_RECRUITING date: 2024-04-10 date: 2024-12-31 date: 2025-01-31 date: 2024-04-09 date: 2024-04-09 name: Fudan University class: OTHER briefSummary: This is a Phase II, open-label, single-arm study evaluating the efficacy and safety of combined treatment of dasatinib, quercetin with chemotherapy in mTNBC (triple negative breast cancer) patients who progressed during previous chemotherapy. conditions: Triple-negative Breast Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: Quercetin name: Dasatinib name: Taxane/Anthracycline/Eribulin Mesylate/Vinorelbine/Capecitabine/Carboplatin/UTD1/platinum measure: Objective Response Rate (ORR) measure: Disease Control Rate (DCR) measure: Progression Free Survival (PFS) measure: Safety and treatment-related AEs measure: Biomarker analysis1 measure: Biomarker analysis2 sex: FEMALE minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<|newrecord|> nctId: NCT06355024 id: A2024.1.30 briefTitle: Inosine Reverse Chemo Resistance in Triple Negative Breast Cancer overallStatus: NOT_YET_RECRUITING date: 2024-04-10 date: 2024-12-31 date: 2025-01-31 date: 2024-04-09 date: 2024-04-09 name: Fudan University class: OTHER briefSummary: This is a Phase II, open-label, single-arm study evaluating the efficacy and safety of combined treatment of Inosine with chemotherapy in mTNBC (triple negative breast cancer) patients who progressed during previous chemotherapy. conditions: Triple-negative Breast Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: Inosine name: Taxane/Anthracycline/Eribulin Mesylate/Vinorelbine/Capecitabine/Carboplatin/UTD1/platinum measure: Objective Response Rate (ORR) measure: Disease Control Rate (DCR) measure: Progression Free Survival (PFS) measure: Biomarker analysis1 measure: Safety and treatment-related AEs sex: FEMALE minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<|newrecord|> nctId: NCT06355011 id: 7016194 briefTitle: Total Elbow Replacement in England: Analysis of National Joint Registry and Hospital Episode Statistics Data overallStatus: COMPLETED date: 2024-03-01 date: 2024-04-02 date: 2024-04-02 date: 2024-04-09 date: 2024-04-09 name: University of Manchester class: OTHER name: The National Joint Registry name: The Royal College of Surgeons of England name: John Charnley Trust name: University of Bristol briefSummary: The goal of this observational registry study is to provide detailed descriptions of the patients who are receiving primary total elbow replacement surgery in England. The main questions it aims to answer are:
* Who are receiving primary total elbow replacement surgery?
* Where and by whom is the total elbow replacement surgery is being performed?
* What the current surgical practices for total elbow replacement?
Pseudonymous data from the National Joint Registry NJR of all patients with total elbow replacement will be used. conditions: Total Elbow Replacement studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 3891 type: ACTUAL name: Total Elbow Replacement measure: The incidence of total elbow replacement (TER) in England measure: Serious adverse events or re-admissions measure: Duration of elective wait measure: Post-operative duration of stay measure: Surgeon volume measure: Hospital volume measure: Patient characteristics (Age) measure: Body mass index measure: Hand dominance measure: American Society of Anaesthesiologists (ASA) grade measure: Indication for total elbow replacement measure: Socioeconomic status measure: Ethnicity measure: Co-morbidities measure: Charlson Comorbidity Index measure: Implant classification measure: Fixation type measure: Implant type measure: If radial head replacement was used measure: Grade of primary surgeon measure: Funding measure: Elective admission type sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Centre for Epidemiology Versus Arthritis, Centre for Musculoskeletal Research, University of Manchester, Manchester Academic Health Science Centre city: Manchester zip: M13 9PT country: United Kingdom lat: 53.48095 lon: -2.23743 hasResults: False
<|newrecord|> nctId: NCT06354998 id: mRNA-1273-P401 briefTitle: A Study of an Investigational mRNA-1273.815 COVID-19 Vaccine in Previously Vaccinated Adults overallStatus: RECRUITING date: 2024-04-08 date: 2024-06-01 date: 2024-06-01 date: 2024-04-09 date: 2024-04-22 name: ModernaTX, Inc. class: INDUSTRY briefSummary: To evaluate immune responses of an Investigational mRNA-1273.815 vaccine against the Omicron subvariant strain (XBB.1.5) of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). conditions: SARS-CoV-2 studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 200 type: ESTIMATED name: Investigational mRNA-1273.815 name: Licensed Spikevax Vaccine measure: Geometric Mean of Neutralizing Antibodies (nAbs) Against SARS-CoV-2-specific Strain at Day 15 measure: Number of Participants with Serious Adverse Events (SAEs), Adverse Events (AEs) of Special Interest (AESIs), and AEs Leading to Withdrawal From the Study measure: Seroresponse Rate of nAb Against the SARS-CoV-2-specific Strain at Day 15 measure: Geometric Mean Ratio of nAb Against the SARS-CoV-2-specific Strain for Investigational mRNA-1273.815 Over the Licensed Spikevax Vaccine at Day 15 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Paratus Canberra status: RECRUITING city: Canberra state: Australian Capital Territory zip: 2617 country: Australia lat: -35.28346 lon: 149.12807 facility: Holdsworth House status: RECRUITING city: Darlinghurst state: New South Wales zip: 2010 country: Australia lat: -33.87939 lon: 151.21925 facility: Paratus Brisbane status: RECRUITING city: Brisbane state: Queensland zip: 2617 country: Australia lat: -27.46794 lon: 153.02809 facility: USC Morayfield status: NOT_YET_RECRUITING city: Morayfield state: Queensland zip: 4506 country: Australia lat: -27.10876 lon: 152.94907 facility: University of the Sunshine Coast, South Bank status: RECRUITING city: South Brisbane state: Queensland zip: 4101 country: Australia lat: -27.48034 lon: 153.02049 facility: Emeritus Melbourne status: RECRUITING city: Camberwell state: Victoria zip: 3124 country: Australia lat: -37.84205 lon: 145.0694 facility: AusTrials Sunshine Hospital status: RECRUITING city: Melbourne state: Victoria zip: 3021 country: Australia lat: -37.814 lon: 144.96332 hasResults: False
<|newrecord|> nctId: NCT06354985 id: 23-5996 id: MODEX2023 type: OTHER domain: Clinical Trial Protocol Number id: FRN:183960 type: OTHER_GRANT domain: CIHR id: CTO Project ID: 4701 type: OTHER domain: Clinical Trials Ontario briefTitle: Modafinil and Exercise for Post Stroke Fatigue acronym: MODEX overallStatus: NOT_YET_RECRUITING date: 2024-10 date: 2027-09 date: 2027-09 date: 2024-04-09 date: 2024-04-09 name: University Health Network, Toronto class: OTHER briefSummary: A stroke happens when blood flow to the brain is stopped and the brain gets damaged. At least half of people with a stroke have fatigue months and even years later. A lot of people report fatigue as one of the worst symptoms post stroke that can affect daily activities and the length and quality of life. Though all the reasons for fatigue after stroke and how to best treat it are not fully understood, the investigators think that fatigue results from the stroke changing the brain, reducing physical fitness, and decreasing muscle strength. A stroke can also affect sleep and mood, which can impact how people feel too. It is also not known why women experience more fatigue than men after a stroke.
Some studies have tested a drug called Modafinil for post stroke fatigue, while other studies have tested exercise for it. Yet, there is unclear evidence for either treatment, so this study has two main aims:
1. Test if Exercise Program One is better than Exercise Program Two
2. Test if Modafinil is better than a Sugar Pill
As another aim, the investigators will also look at if combining Modafinil with exercise has any benefits.
This study will take place at 6 Canadian research sites to give a good representation of people after a stroke. Each person will be tested on fatigue, mood, fitness, thinking skills, sleep, and usual activity levels.
Participants will be assigned at random (like flipping a coin) to 1 of 4 groups:
1. Sugar Pill plus Exercise Program One
2. Sugar Pill plus Exercise Program Two
3. Modafinil plus Exercise Program One
4. Modafinil plus Exercise Program Two
The treatment will last 8 weeks. The Modafinil or Sugar Pill will be taken once a day. The exercise will be delivered virtually by a trained therapist over computer to people at home 3 times a week. Change in fatigue, quality of life, and other outcomes will be measured over 6 months.
The investigators will assess the results to identify the best treatment for post stroke fatigue and hope to be able to find a treatment that will help reduce fatigue and improve quality of life after a stroke. conditions: Stroke conditions: Fatigue conditions: Modafinil conditions: Exercise studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: FACTORIAL primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: All members of the research team and the participants will be blinded to medication group allocation, but cannot be blinded to exercise group allocation. Evaluators and the study statistician will be blinded to the exercise group allocation. The study statistician and the rest of the Data Safety Monitoring Board will have access to the medication assignment if needed (e.g. adverse drug reaction). whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 224 type: ESTIMATED name: Modafinil 200mg name: Placebo name: Exercise Program One name: Exercise Program Two measure: Severity of Fatigue Symptoms measure: Severity of Fatigue Symptoms measure: Impact on Quality of Life measure: Walking Recovery measure: Leg Strength and Coordination measure: 3-Day Physical Activity Assessment measure: Mood and Anxiety measure: Attention measure: Cognition measure: Health Resource Utilization measure: Quality Adjusted Life Years sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<|newrecord|> nctId: NCT06354972 id: SASP Turin briefTitle: Impact of SASP in the GCF on the Outcomes of Periodontal Regeneration overallStatus: COMPLETED date: 2022-01-02 date: 2022-11-02 date: 2024-01-02 date: 2024-04-09 date: 2024-04-09 name: University of Turin, Italy class: OTHER briefSummary: Objectives: To test the impact of clinical inflammation and molecular expression profile (senescence-associated secretory phenotype; SASP) in the gingival crevicular fluid (GCF) on the outcomes of minimally-invasive periodontal regeneration in intra-bony defects.
Methods: Sites associated with intrabony defects ≥ 3 mm requiring periodontal regeneration through minimally-invasive surgical technique were included. Pre-operatively, GCF was sampled for inflammatory biomarker analysis related to SASP \[interleukin (IL)-1β, IL-6 and IL-12; matrix-metalloproteinases (MMP)-8 and -9\]. Correlation analyses and logistic regression models were performed to assess the impact of predictors on clinical and radiographic outcomes. conditions: Periodontal Diseases studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: RETROSPECTIVE count: 40 type: ACTUAL name: Minimally invasive surgical procedure measure: Clinical attachment level change measure: Achievement of composite outcome measure measure: Radiographic bone level change measure: Probing pocket depth change sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CIR Dental School city: Turin zip: 10126 country: Italy lat: 45.07049 lon: 7.68682 hasResults: False
<|newrecord|> nctId: NCT06354959 id: 1030020 briefTitle: Prehab for Lung and Esophageal Cancer overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2026-06-01 date: 2027-01-01 date: 2024-04-09 date: 2024-04-09 name: Nova Scotia Health Authority class: OTHER name: Dalhousie University briefSummary: Research indicates that individuals diagnosed with lung or esophageal cancer who enter treatment with higher functional capacities, improved body composition, and better nutrition status tend to experience better outcomes and a higher quality of life. The primary objective of a prehabilitation health coaching program is to enhance the overall health and well-being of patients before they undergo major surgery.This personalized 8-week program encompasses elements such as nutrition, smoking cessation, sleep hygiene, and movement, equipping participants with the knowledge and tools needed to adopt healthier lifestyles. conditions: Neoplasm of Lung conditions: Neoplasms conditions: Exercise conditions: Surgery studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 25 type: ESTIMATED name: Prehabilitation measure: Feasibility- Recruitment measure: Feasibility- Participant fidelity measure: Feasibility - Safety measure: Feasibility - Retention/Attrition measure: Feasibility - Participant Experience measure: Feasibility- Attendance measure: Functional Assessment of Cancer Therapy - Lung OR Esophageal (FACT-L/ FACT- E) measure: Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) measure: 5x chair stand measure: Stair climb test measure: Grip strength measure: Resting Heart rate measure: Resting blood pressure sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Victoria General Hospital city: Halifax state: Nova Scotia country: Canada name: Jodi Langley role: CONTACT email: [email protected] lat: 44.64533 lon: -63.57239 hasResults: False
<|newrecord|> nctId: NCT06354946 id: SCORE 4C briefTitle: External Validation of Simplified 4C Mortality Score by Deleting CRP acronym: 4Cs overallStatus: COMPLETED date: 2020-01-01 date: 2022-11-30 date: 2022-12-30 date: 2024-04-09 date: 2024-04-09 name: University of Monastir class: OTHER briefSummary: The (Coronavirus Clinical Characterisation Consortoum) 4C mortality score is an accessible risk stratification score developed by the International Severe Acute Respiratory and Emerging Infections Consortium (ISARIC) based on eight different parameters: age, sex, number of comorbidities, respiratory rate, peripheral oxygen saturation, level of consciousness (Glasgow Coma Scale), urea or blood urea nitrogen (BUN) level, and C reactive protein (CRP). It was derived and internally validated on a large, diverse cohort within the United Kingdom but requires external validity to confirm its generalizability. A recent validation study demonstrated that the score could be simplified by deleting CRP item which is favorable to its widespread use. we aim to validate a modified 4C score. conditions: COVID-19 Pandemic studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 1500 type: ACTUAL measure: The primary outcome was all-cause in-hospital mortality rate The primary outcome was all-cause in-hospital mortality rate measure: Number of patients admitted to the ICU sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: EPS Fattouma Bourguiba University hospital city: Monastir zip: 5020 country: Tunisia lat: 35.77799 lon: 10.82617 hasResults: False
<|newrecord|> nctId: NCT06354933 id: DemeNSS (3785) briefTitle: Neurological Soft Signs in Neurodegenerative Dementias acronym: DemeNSS overallStatus: COMPLETED date: 2022-04-01 date: 2023-11-30 date: 2024-02-01 date: 2024-04-09 date: 2024-04-15 name: University of Milano Bicocca class: OTHER briefSummary: The goal of this observational study is to investigate the prevalence of Neurological Soft Signs (NSS) in various categories of dementia patients compared to matched controls. The main questions it aims to answer are:
* Does the prevalence of NSS significantly differ among patients with neurodegenerative dementias compared to controls?
* Are NSS associated with neuropsychiatric alterations in dementia patients?
* Do NSS correlate with cognitive screening tools?
* Do NSS increase over time in patients with neurodegenerative dementias?
Participants will undergo assessments including:
* Evaluation of NSS using the Heidelberg scale
* Neuropsychiatric assessments
* Cognitive screening using the Mini-Mental State Examination (MMSE) and Frontal Assessment Battery (FAB)
Researchers will compare dementia groups (Alzheimer's disease, Frontotemporal dementia, Corticobasal syndrome and Lewy body dementia) to controls to determine differences in NSS prevalence. Additionally, associations between NSS and neuropsychiatric symptoms, as well as cognitive performance, will be explored. conditions: Alzheimer Disease conditions: Dementia With Lewy Bodies conditions: Frontotemporal Dementia conditions: Corticobasal Degeneration studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 186 type: ACTUAL name: Neurological Soft Signs measure: Difference in NSS measure: Association between NSS and Neuropsychiatric Inventory (NPI) scores measure: Correlation between NSS scores and cognitive function assessed by Mini-Mental State Examination (MMSE) measure: Correlation between NSS scores and cognitive function assessed by Frontal Assessment Battery (FAB) measure: Longitudinal changes in NSS scores sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fondazione IRCCS San Gerardo dei Tintori city: Monza state: Lombardia zip: 20900 country: Italy lat: 45.58005 lon: 9.27246 hasResults: False
<|newrecord|> nctId: NCT06354920 id: HUM00247781 id: R18HS028963 type: AHRQ link: https://reporter.nih.gov/quickSearch/R18HS028963 briefTitle: M-Well Bonding Bundle to Improve Patient-Physician Relationships overallStatus: RECRUITING date: 2024-04-08 date: 2026-06 date: 2026-06 date: 2024-04-09 date: 2024-04-10 name: University of Michigan class: OTHER name: Agency for Healthcare Research and Quality (AHRQ) briefSummary: The goal of this clinical trial is to learn more about the interaction between a patient in the hospital and their treating doctor. A good relationship between patients and their doctors can help improve patient care. Doctors will be asked to use strategies to improve their interactions with patients in the hospital. The main questions it aims to answer are:
* Will using the intervention strategies improve doctors' empathy towards their patients?
* Will using the intervention strategies lead to improved scores in patient views of doctors' empathy?
There will be 2 study arms. One group of doctors will be asked to use the intervention strategies. The other group of doctors will provide care as they would normally.
Researchers will compare the doctors in the intervention arm to those in the control arm.
Doctors are the primary subjects for this study. The doctors in both study arms will be asked to do the following:
1. Allow study staff to observe the interaction between them and their patients.
2. Complete a brief survey at the end of their 2-week work rotation.