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Expected Outcomes:
Validation of EBC-GM Diagnostic Accuracy: Anticipate demonstrating that EBC-GM levels provide a comparable diagnostic accuracy to BALF-GM, establishing a non-invasive, safer alternative for IPA detection.
Implementation of a Non-Invasive Diagnostic Tool: The study aims to introduce a non-invasive diagnostic approach that can potentially replace more risky, invasive methods, improving patient care in ICUs.
Contribution to Clinical Practice: By providing a new method for early and safer detection of IPA, the study is expected to influence clinical guidelines and practices in the management of critically ill, ventilated patients.
Significance: This research has the potential to revolutionize the diagnosis of fungal infections in critically ill patients by offering a non-invasive, accurate, and safer diagnostic tool, thereby improving patient outcomes and reducing the risks associated with invasive diagnostic procedures. conditions: Bronchoalveolar Lavage Fluid conditions: Sensitivity and Specificity conditions: Critical Illness conditions: Respiration Failure conditions: Respiratory Fungal Infection conditions: Exhaled Breath Condensate conditions: Aspergillosis, Invasive Pulmonary studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 75 type: ACTUAL name: Compare the levels of Galactomannan (GM) levels in exhaled breath condensate (EBC) and BALF measure: Diagnostic accuracy of EBC-GM vs. BALF-GM measure: EBC-GM levels: measure: Correlation between EBC-GM and BALF-GM levels sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sichuan Provincial People's Hospital city: Chengdu state: Sichuan zip: 86610072 country: China lat: 30.66667 lon: 104.06667 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2023-04-12 uploadDate: 2024-03-22T15:01 filename: Prot_SAP_000.pdf size: 81579 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2023-04-12 uploadDate: 2024-03-22T15:02 filename: ICF_001.pdf size: 133154 hasResults: False
<\|newrecord\|> nctId: NCT06333366 id: 202301590A0C501 id: Application No.2402020052 type: OTHER domain: Chang Gung Memorial Hospital briefTitle: First-In-Human Study of PDT to Detect IAH overallStatus: RECRUITING date: 2024-02-18 date: 2024-07-16 date: 2025-09-20 date: 2024-03-27 date: 2024-03-27 name: Chang Gung Memorial Hospital class: OTHER name: DOTSPACE briefSummary: PDT is a continuous pressure monitoring for Intra-Abdominal hypertension (IAH) designed to be less invasive than pan-endoscopic evaluation, more tolerable than abdominal tapping, and more effective than intravesical pressure measurement for IAH. The PDT device consists of a piezoelectric sensor module with a low power Bluetooth wireless transmitter encased in biocompatible capsule. The device will be swallowed after activation. Following PDT insertion, the patient is fitted with a custom, removable external waist accessory containing a receiver, which is worn during monitoring and provide PDT location by signal analysis with sufficient information to provide IAH trends. conditions: Intra-Abdominal Hypertension studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 10 type: ESTIMATED name: Intra-gastrointestinal monitoring device (PDT) measure: Incidence of device-related or sensor insertion/removal procedure-related adverse events measure: Rate of foreign body reaction due intra-gastrointestinal insertion measure: Rate of GI symptoms, i.e. inflammation, infection, diarrhea, bowel obstruction, and ileus measure: Incidence of sensor failure measure: Percentage of users feedback in the form of clinical questionnaire to assess the 'easiness' of insertion procedure with questionnaire measure: Duration of PDT insertion and explantation procedure measure: Incidence of side effects in Post explantation follow-up measure: Rate of GI dysfunction after 10 days post explantation of the PDT sensor. Follow-up via phone call after 30 days measure: Rate of sensor ability to measure intra-gastrointestinal pressure (IGP) to allow the development of the algorithm measure: Incidence of influence of interference substances (i.e. water, saliva, gastric juice, bile, intestinal secretion, feces, and food debris ) sex: ALL minimumAge: 20 Years maximumAge: 55 Years stdAges: ADULT facility: Dong-Ru Ho status: RECRUITING city: Chiayi City zip: 60061 country: Taiwan name: Dong-Ru Ho, MD, PhD role: CONTACT phone: 886-975353211 email: redoxdrh@gmail.com role: CONTACT phoneExt: Ho email: redoxdrh@gmail.com name: Dong-Ru Ho, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 23.47917 lon: 120.44889 hasResults: False
<\|newrecord\|> nctId: NCT06333353 id: H-06-23-9278 briefTitle: Is Repetitive Transcranial Magnetic Stimulation Effective in Reducing Endometriosis-associated Pain overallStatus: RECRUITING date: 2024-04-12 date: 2027-05-20 date: 2027-06-20 date: 2024-03-27 date: 2024-04-15 name: University of Ottawa class: OTHER briefSummary: The goal of this research is to improve pain outcomes for the over 500K Canadian women, girls and gender-diverse individuals who are newly diagnosed with endometriosis each year. Chronic pain that persists after interventions for endometriosis is a huge problem. There is some evidence that endometriosis-associated pain (EAP) is, at least to some extent, associated with changes in pain physiology, particularly central sensitization of pain. There is currently no effective evidence-informed intervention that addresses EAP. Yet a recent feasibility trial on a repetitive transcranial magnetic stimulation (rTMS) intervention demonstrated promising results compared to a sham intervention for reducing pain in a sample with EAP.
The objectives of this trial are:
1. to evaluate the effectiveness of an rTMS intervention for pain reduction among those with recalcitrant post-operative EAP,
2. to inform on the utility of a long (10 session) vs short (5 session) protocol for pain reduction among those with recalcitrant post-operative EAP
3. to determine if any improvements in pain observed 30 days after an rTMS intervention are retained 6 months later
4. to identify physical and psychosocial mediators that impact the successful reduction of pain among patients with EAP treated using rTMS.
5. to describe patients' perceptions of and satisfaction with rTMS as an intervention for EAP. conditions: Endometriosis conditions: Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Parallel Assignment primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: All participants, care providers, investigators and outcome assessors will remain blinded to real/sham intervention. The outcomes assessor and the investigator will remain blinded to intervention duration. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 152 type: ESTIMATED name: Real RepetitiveTranscranial Magnetic Stimulation 5 sessions name: Sham RepetitiveTranscranial Magnetic Stimulation 5 sessions name: Real RepetitiveTranscranial Magnetic Stimulation 10 sessions name: Sham RepetitiveTranscranial Magnetic Stimulation 10 sessions measure: Numeric rating scale (NRS) used to record daily pain over 30 days measure: Numeric rating scale(NRS) used to record daily pain over 30 days measure: Patient Global Impression of Change (PGIC) in pain measure: Patient Global Impression of Change (PGIC) in pain measure: Patient Global Impression of Change (PGIC) in pain measure: The Beck Depression Inventory (BDI-II) measure: The Beck Depression Inventory (BDI-II) measure: The Beck Depression Inventory (BDI-II) measure: The State-Trait Anxiety Inventory (STAI) measure: The Pain Catastrophizing Scale measure: The Central sensitization index measure: Female Sexual Distress Scale (FSDS) measure: Adherence to the intervention protocol measure: Pressure pain threshold (PPThresh) measure: Pressure pain threshold (PPThresh) measure: Pressure Pain Tolerance (PPTol) measure: Pressure Pain Tolerance (PPTol) measure: Perceived pain intensity (PPI) measure: Perceived pain intensity (PPI) measure: Temporal summation (TS) of pain measure: Temporal summation (TS) of pain measure: Pain rating during the tampon test measure: Pain rating during the tampon test measure: Conditioned pain modulation (CPM) measure: Conditioned pain modulation (CPM) measure: The Brief Pain Inventory measure: The Brief Pain Inventory measure: The Brief Pain Inventory measure: The Endometriosis Health Profile Questionnaire (EPH-30) measure: The Endometriosis Health Profile Questionnaire (EPH-30) measure: The Endometriosis Health Profile Questionnaire (EPH-30) measure: Patient satisfaction with treatment (PST) measure: Patient satisfaction with treatment (PST) measure: Patient satisfaction with treatment (PST) sex: FEMALE minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: McLean Function Measurement Lab status: RECRUITING city: Ottawa state: Ontario zip: K1S1S2 country: Canada name: Anne-Marie MacDonald, MSc role: CONTACT phone: 613-562-5800 phoneExt: 4102 email: mfmlab@uottawa.ca name: Linda McLean, PhD role: CONTACT phone: 613-562-5800 phoneExt: 4102 email: lmclea2@uottawa.ca name: Linda McLean, PhD role: PRINCIPAL_INVESTIGATOR lat: 45.41117 lon: -75.69812 hasResults: False
<\|newrecord\|> nctId: NCT06333340 id: 24-03 briefTitle: Comparative Efficacy of Carbetocin and Oxytocin in Parturients at Risk of Atonic Postpartum Hemorrhage Undergoing Elective Cesarean Delivery overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-03 date: 2025-03 date: 2024-03-27 date: 2024-04-12 name: Samuel Lunenfeld Research Institute, Mount Sinai Hospital class: OTHER briefSummary: The goal of this study is to compare 2 medications that are commonly used to prevent excess uterine bleeding (postpartum hemorrhage, or PPH) following cesarean delivery (CD), oxytocin and carbetocin. Most of the trials evaluating the preventative role of oxytocin and carbetocin after CD have focused on patient with low-risk of PPH.
This trial will focus on patients that are at increased risk of PPH, with risk factors such as: multiple gestation (twins, or more multiples), large baby, polyhydramnios (excess amniotic fluid), history of PPH, body mass index greater than 40, diabetes mellitus, hypertension, and placenta previa.
The investigators hypothesize that carbetocin would be more effective than an oxytocin regimen in reducing the risk of PPH in patients undergoing CD with any of the biological high-risk factors. conditions: Post Partum Hemorrhage studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 160 type: ESTIMATED name: Oxytocin name: Carbetocin measure: Proportion of parturients requiring additional uterotonic agents intraoperatively measure: Uterine Tone 3 minutes measure: Uterine Tone 5 minutes measure: Uterine Tone 10 minutes measure: Calculated blood loss (CBL) measure: Semi-quantitative blood loss (SQBL) measure: Presence of blood transfusion measure: Number of patients with ICU admission measure: Number of patients with conservative surgical methods to manage post partum hemorrhage measure: Number of patients with radiological methods used to manage post partum hemorrhage measure: Number of patients with surgical post partum hemorrhage management measures measure: Number of patients with hypotension defined as systolic blood pressure less than 80% of baseline measure: Number of patients with hypertension defined as systolic blood pressure greater than 120% of baseline measure: Number of patients with tachycardia defined as heart rate greater than 130% of baseline measure: Number of patients with bradycardia defined as heart rate less than 70% of baseline measure: Presence of ventricular tachycardia: ECG measure: Presence of atrial fibrillation: ECG measure: Presence of atrial flutter: ECG measure: Presence of nausea: questionnaire measure: Presence of vomiting: questionnaire measure: Number of patients with chest pain: questionnaire measure: Number of patients with shortness of breath: questionnaire measure: Number of patients with headache: questionnaire measure: Number of patients with flushing: questionnaire sex: FEMALE minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Mount Sinai Hospital city: Toronto state: Ontario zip: M5G1X5 country: Canada name: Mrinalini Balki, MD role: CONTACT phone: 416-586-4800 phoneExt: 5270 email: mrinalini.balki@uhn.ca name: Narinder Singh, MD role: SUB_INVESTIGATOR name: Ronald George, MD role: SUB_INVESTIGATOR name: Kristi Downey, MSc role: SUB_INVESTIGATOR lat: 43.70011 lon: -79.4163 hasResults: False
<\|newrecord\|> nctId: NCT06333327 id: 1432022000278 briefTitle: Multicenter Registry of Atrial Fibrillation Ablation With Radiofrequency Balloon Catheter acronym: COLLABORATE overallStatus: RECRUITING date: 2021-01-01 date: 2030-01-01 date: 2030-12-01 date: 2024-03-27 date: 2024-03-27 name: Universitair Ziekenhuis Brussel class: OTHER briefSummary: All consecutive patients with paroxysmal or persistent atrial fibrillation undergoing pulmonary vein isolation with the radiofrequency balloon catheter (RFB) "Heliostar" (Biosense Webster) will be included in a multicenter observational registry. The aim of the study is to assess the safety and arrhythmic outcome of atrial fibrillation ablation with the RFB in a real-world setting. conditions: Atrial Fibrillation studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 2000 type: ESTIMATED name: Pulmonary vein isolation with the multielectrode radiofrequency balloon catheter measure: Atrial arrhythmia recurrence after ablation measure: Procedural safety sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UZ Brussel Heart Rhythm Management Center status: RECRUITING city: Brussels zip: 1090 country: Belgium name: Carlo de Asmundis, MD, PhD role: CONTACT phone: +32024763704 email: hrmc@uzbrussel.be lat: 50.85045 lon: 4.34878 hasResults: False
<\|newrecord\|> nctId: NCT06333314 id: UC-IMM-2302 briefTitle: Dostarlimab for Locally Advanced or Metastatic Cancer (Non-colorectal/Non-endometrial) With Tumor dMMR/MSI acronym: Pan-MSI-ACSE overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2028-10 date: 2030-09 date: 2024-03-27 date: 2024-03-29 name: UNICANCER class: OTHER name: National Cancer Institute, France name: GlaxoSmithKline briefSummary: The goal of this open-label randomized, multicenter, comparative phase II trial is to evaluate the efficacy of the immunotherapy, dostarlimab, as first-line treatment for deficient mismatch repair (dMMR)/microsatellite instability (MSI) non-resectable metastatic or locally advanced non-colorectal and non-endometrial cancers compared to the standard of care chemotherapy.
Adult patients (aged ≥18 years) with histologically confirmed dMMR/MSI duodenum and small bowel adenocarcinoma, gastric and oeso-gastric junction (OGJ) adenocarcinoma with combined positive score (CPS)\<5, pancreatic adenocarcinoma, ampulla of vater adenocarcinoma, adrenocortical carcinoma, carcinoma of unknown primary site, neuroendocrine carcinoma (Grade3) all primary, and soft tissue sarcoma (except Gastro-Intestinal Stromal Tumor) will be included in this study. They will be randomized and treated with either dostarlimab (experimental arm A), or chemotherapy (control arm B).
Patients with documented disease progression following the first line chemotherapy (Arm B) may be eligible for crossover to be treated with dostarlimab, with the same schedule as arm A. conditions: Pancreatic Adenocarcinoma conditions: Ampulla of Vater Carcinoma conditions: Adrenocortical Carcinoma conditions: Neuroendocrine Carcinoma conditions: Soft Tissue Sarcoma conditions: Small Bowel Adenocarcinoma conditions: Duodenum Adenocarcinoma conditions: Gastric Adenocarcinoma studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized, multicenter, comparative phase II trial primaryPurpose: TREATMENT masking: NONE count: 120 type: ESTIMATED name: Dostarlimab name: Chemotherapy measure: Progression-free survival measure: Objective Response Rate measure: Duration of response measure: Overall Survival measure: Progression-Free Survival 2 measure: Objective response rate 2 measure: Progression-Free Survival -crossover measure: Circulating tumor DNA level measure: Incidence of treatment-emergent adverse events measure: Quality of life questionnaire - Core 30 (QLQ-C30) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Institut de Cancérologie de l'Ouest city: Angers country: France name: Victor SIMMET, MD role: CONTACT lat: 47.46667 lon: -0.55 facility: Institut du Cancer Avignon-Provence city: Avignon country: France name: Clémence TOULLEC, MD role: CONTACT lat: 43.94834 lon: 4.80892 facility: CHU Jean Minjoz city: Besançon country: France name: Angélique VIENOT, MD role: CONTACT lat: 47.24878 lon: 6.01815 facility: CHU Morvan city: Brest country: France name: Pierre-Guillaume POUREAU, MD role: CONTACT lat: 48.3903 lon: -4.48628 facility: Centre François Baclesse city: Caen country: France name: Elodie COQUAN, MD role: CONTACT lat: 49.18585 lon: -0.35912 facility: Centre Jean Perrin city: Clermont-Ferrand country: France name: Florence OSAER-POLYCARPE, MD role: CONTACT lat: 45.77966 lon: 3.08628 facility: CHU - Henri Mondor city: Créteil country: France name: Christophe TOURNIGAND, MD role: CONTACT lat: 48.78333 lon: 2.46667 facility: Centre Georges François Leclerc city: Dijon country: France name: François GHIRINGHELLI, MD role: CONTACT lat: 47.31667 lon: 5.01667 facility: Centre Léon Bérard city: Lyon country: France name: Clélia COUTZAC, MD role: CONTACT lat: 45.74848 lon: 4.84669 facility: Hôpital la Timone city: Marseille country: France name: Laëtitia DAHAN, MD role: CONTACT lat: 43.29551 lon: 5.38958 facility: Institut Paoli Calmettes city: Marseille country: France name: Christelle DE LA FOUCHARDIERE, MD role: CONTACT lat: 43.29551 lon: 5.38958 facility: Institut de Cancérologie de Lorraine city: Nancy country: France name: Aurélien LAMBERT, MD role: CONTACT lat: 48.68439 lon: 6.18496 facility: Institut Mutualiste Montsouris city: Paris country: France name: Raphaël COLLE, MD role: CONTACT lat: 48.85341 lon: 2.3488 facility: CHU de Bordeaux - Hôpital Haut -Lèvêque city: Pessac country: France name: Denis SMITH, MD role: CONTACT lat: 44.81011 lon: -0.64129 facility: CHU de Poitiers city: Poitiers country: France name: David TOUGERON, MD role: CONTACT lat: 46.58333 lon: 0.33333 facility: Institut Jean Godinot city: Reims country: France name: Damien BOTSEN, MD role: CONTACT lat: 49.25 lon: 4.03333 facility: Centre Eugène Marquis city: Rennes country: France name: Héloïse BOURIEN, MD role: CONTACT lat: 48.11198 lon: -1.67429 facility: CHU de Rouen city: Rouen country: France name: Frédéric DI FIORE, MD role: CONTACT lat: 49.44313 lon: 1.09932 facility: Institut de Cancérologie de l'Ouest city: Saint-Herblain country: France name: Sandrine HIRET, MD role: CONTACT lat: 47.21765 lon: -1.64841 facility: CHU de Toulouse Hôpital Rangueil city: Toulouse country: France name: Rosine GUIMBAUD, MD role: CONTACT lat: 43.60426 lon: 1.44367 facility: Gustave Roussy Grand Paris city: Villejuif country: France name: Cristina SMOLENSCHI, MD role: CONTACT lat: 48.7939 lon: 2.35992 facility: Hôpital Saint-Antoine city: Paris state: Île-de-France country: France name: Thierry ANDRE, MD role: CONTACT lat: 48.85341 lon: 2.3488 hasResults: False
<\|newrecord\|> nctId: NCT06333301 id: TIME-ZZZ briefTitle: Translational Initiative to Map Epigenetics in Sleep acronym: TIME-ZZZ overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2034-04 date: 2034-04 date: 2024-03-27 date: 2024-03-27 name: Elysium Health class: INDUSTRY name: University of Oxford briefSummary: The primary aim of TIME-ZZZ is to explore the relationship between chronotype, incidence of depression and biological age, and whether individuals working "out-of-phase" with their chronotype are more likely to exhibit signs of depression and accelerated biological aging. conditions: Biological Aging studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 10000 type: ESTIMATED name: Surveys measure: Effect of being "out of phase" with chronotype on biological age measure: Effect of Chronotype Alignment and Depression Risk in Relation to Rate of Aging measure: Identification of DNA methylation markers associated with chronotype measure: Identification of DNA methylation markers associated with depression sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06333288 id: 2024-0268 briefTitle: Pilot Trial to Evaluate PROblem Solving Therapy and APPLE Watch for College Students overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2024-11-30 date: 2025-03-30 date: 2024-03-27 date: 2024-03-27 name: University of Illinois at Chicago class: OTHER briefSummary: The goals of this Pilot Trial are to test the preliminary efficacy of Problom-Solving Therapy (PST)-APPLE Watch in a 2-arm pilot Randomized Control Trial (RCT), vs education only-control to reduce alcohol use disorder symptoms and improve alcohol abstinence. conditions: Alcohol Use Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: PRO-APPLE Study is a 2-arm pilot Randomized Control Trial (RCT). primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 44 type: ESTIMATED name: PST-APPLE Watch group name: Education-only control group measure: Alcohol abstinence measure: Change in AUD severity at 3 months. measure: Change in AUD frequency status. measure: Change in Alcohol-related negative consequences at 3 months. measure: Change in Alcohol use at 3 months. measure: Change in Reasons for drinking at 3 months. measure: Change in negative affect at 3 months. measure: Change in positive affect at 3 months. measure: Change in Cognitive performance (executive cognitive ability and attention and working memory) at 3 months. measure: Change in the quality of life at 3 months. measure: Percent heavy drinking days at 3 months. measure: Percent binge drinking days at 3 months. measure: Percent days abstinence at 3 months. measure: Intervention Acceptability measure: Intervention Fidelity measure: Participant Retention measure: Protocol Acceptability sex: ALL minimumAge: 18 Years maximumAge: 25 Years stdAges: ADULT facility: University of Illinois at Chicago city: Chicago state: Illinois zip: 60608 country: United States name: Hagar Hallihan role: CONTACT lat: 41.85003 lon: -87.65005 hasResults: False
<\|newrecord\|> nctId: NCT06333275 id: DLF-Nr: 5564 id: BASEC-Nr: 2023-01141 type: OTHER domain: BASEC (Business Administration System for Ethics Committees) - Switzerland briefTitle: Restoration of Immunity to Vaccine Preventable Diseases After CART-T Cell Therapy acronym: IMCAR overallStatus: RECRUITING date: 2023-11-14 date: 2025-12 date: 2026-12 date: 2024-03-27 date: 2024-03-27 name: Insel Gruppe AG, University Hospital Bern class: OTHER briefSummary: The goal of this observational study is to learn about vaccine immunity in patients with B-cell malignancies treated by chimeric antigen receptor T-cell therapies (CAR-T). The main questions it aims to answer are:
* Do CAR-T cell therapy recipients lose vaccine protection against common vaccine-preventable pathogens
* Are current re-vaccination recommendations sufficient in restoring vaccine-protection
* Is this restored vaccine-protection after CAR-T cell therapy lost faster than usual
* Do clinical or immunological factors predict vaccine response after CAR-T cell therapy conditions: Vaccine Immunity in CAR-T Cell Therapy Recipients studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 80 type: ESTIMATED name: Vaccines against: Diphtheria, tetanus, pertussis, polio, haemophilus influenza type b, varicella and measles measure: CAR-T cell therapy associated change in antibody levels against 5 vaccine preventable pathogens measure: Rate of seroprotection against tetanus 6 months after CAR-T cell therapy measure: Rate of seroprotection against haemophilus influenza type B 6 months after CAR-T cell therapy measure: Rate of seroprotection against hepatitis B virus 6 months after CAR-T cell therapy measure: Rate of seroprotection against poliovirus 6 months after CAR-T cell therapy measure: Rate of seroprotection against measles virus 12 months after CAR-T cell therapy measure: Rate of seroprotection against tetanus after re-vaccination following CAR-T cell therapy measure: Rate of seroprotection against haemophilus influenza type B after re-vaccination following CAR-T cell therapy measure: Rate of seroprotection against hepatitis B virus after re-vaccination following CAR-T cell therapy measure: Rate of seroprotection against poliovirus after re-vaccination following CAR-T cell therapy measure: Rate of seroprotection against measles after re-vaccination following CAR-T cell therapy measure: Clinical predictors of vaccine elicited immune response measure: Immunological predictors of vaccine elicited immune response measure: Persistence of vaccine elicited seroprotection sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital Bern status: RECRUITING city: Bern zip: 3010 country: Switzerland name: Lukas N Baumann, MD role: CONTACT phone: +41 31 66 4 30 69 email: lukas.baumann2@insel.ch name: Cédric Hirzel, PD, MD role: CONTACT phone: +41 31 66 4 01 17 email: cedric.hirzel@insel.ch name: Christine Thurnheer Zürcher, PD, MD role: PRINCIPAL_INVESTIGATOR name: Cédric Hirzel, PD, MD role: PRINCIPAL_INVESTIGATOR name: Lukas N Baumann, MD role: SUB_INVESTIGATOR name: Urban Novak, Professor role: SUB_INVESTIGATOR lat: 46.94809 lon: 7.44744 hasResults: False
<\|newrecord\|> nctId: NCT06333262 id: 24-017 briefTitle: Fixed Duration Pirtobrutinib and Obinutuzumab in Chronic Lymphocytic Leukemia overallStatus: RECRUITING date: 2024-04 date: 2027-02-01 date: 2029-02-01 date: 2024-03-27 date: 2024-04-23 name: Inhye Ahn class: OTHER name: Loxo Oncology, Inc. briefSummary: This study will evaluate fixed-duration therapy with pirtobrutinib and obinutuzumab given over 12 cycles (approximately 1 year) as first-line treatment of chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL or SLL). conditions: Chronic Lymphocytic Leukemia conditions: Small Lymphocytic Lymphoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: Pirtobrutinib name: Obinutuzumab measure: Rate of complete response after initial therapy measure: Overall response rate measure: Rate of partial response measure: Time to next line of therapy measure: Event-free survival measure: Progression-free survival measure: Overall survival measure: Rate of re-treatment with pirtobrutinib sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Beth Israel Deaconess Medical Center status: RECRUITING city: Boston state: Massachusetts zip: 02215 country: United States name: Jon Arnason, MD role: CONTACT name: Jon Arnason, MD role: PRINCIPAL_INVESTIGATOR lat: 42.35843 lon: -71.05977 facility: Brigham & Women's Hospital status: RECRUITING city: Boston state: Massachusetts zip: 02215 country: United States name: Inhye Ahn role: CONTACT name: Inhye Ahn, MD role: PRINCIPAL_INVESTIGATOR lat: 42.35843 lon: -71.05977 facility: Dana-Farber Cancer Institute status: RECRUITING city: Boston state: Massachusetts zip: 02215 country: United States name: Megan Forsyth role: CONTACT phone: 857-215-1405 email: megan_forsyth@dfci.harvard.edu name: Inhye Ahn, MD role: PRINCIPAL_INVESTIGATOR lat: 42.35843 lon: -71.05977 hasResults: False
<\|newrecord\|> nctId: NCT06333249 id: AGTC-RPGR-001 SKYLINE briefTitle: A Study Comparing Two Doses of AGTC-501 in Male Subjects With X-linked Retinitis Pigmentosa Caused by RPGR Mutations (SKYLINE) overallStatus: ACTIVE_NOT_RECRUITING date: 2021-04-13 date: 2023-04-11 date: 2027-02 date: 2024-03-27 date: 2024-03-27 name: Beacon Therapeutics class: INDUSTRY briefSummary: This study will evaluate the safety and efficacy of a recombinant adeno-associated virus vector (rAAV2tYF-GRK1-RPGR) in patients with X-linked retinitis pigmentosa caused by RPGR mutations. conditions: X-Linked Retinitis Pigmentosa studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The purpose of the Phase 2 study is to evaluate the efficacy, safety, and tolerability of two doses of AGTC-501 in male subjects between 8 - 50 years of age (inclusive) with XLRP genetically confirmed by at least one pathogenic variant in the RPGR gene.
Approximately 12 subjects who meet the inclusion criteria, will be randomized in a 1:1 ratio to 1 of 2 treatment groups. Each subject will receive the assigned dose of AGTC-501 in the study eye; no treatment will be administered in the fellow eye. As treatment outcomes in pediatric vs. adult subjects may differ, randomization to dose groups will be stratified by age.
Each subject will receive a central subretinal injection of AGTC-501 at the assigned dose in the central macula of the study eye. primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: The Phase 2 study is a masked study; therefore, neither the investigator nor the subject will know the dose assignment. Both the subject and the investigator will know which eye received treatment. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 14 type: ACTUAL name: rAAV2tYF-GRK1-RPGR measure: The difference in the proportion of responding eyes between treated and control eyes in the low dose group and high dose group at 12 months, as measured by MAIA microperimetry, where response is defined as a 7dB or more improvement in at least 5 loci. measure: Proportion of responding eyes in treated eyes versus control eyes in the low dose group and the high dose group at Month 12 where responder is defined as an ORA-VNC mobility test score improvement of 2 or more luminance levels. measure: Proportion of responding eyes in treated versus control eyes in the low dose group and the high dose group at Month 12, as measured by MAIA microperimetry, where responder is defined as a 7 dB or more improvement in at least 5 loci within bleb. measure: Proportion of responding eyes in treated vs control eyes in the low dose group and the high dose group at Month 12, measured by MAIA microperimetry where responder is defined as 7 dB or more improvement in at least 5 loci within the central 16 loci measure: Difference in mean change from baseline in the central 36 loci (C36) mean sensitivity, as measured by MAIA microperimetry, in treated eyes versus control eyes in the low dose group and high dose group at Month 12. measure: Difference in mean change from baseline in "within bleb" mean sensitivity, as measured by MAIA microperimetry, in treated eyes versus control eyes in the low dose group and high dose group at Month 12. measure: Difference in mean change from baseline in central 10 degrees of vision on light adapted static perimetry, as measured by Octopus 900, in treated eyes versus control eyes in the low dose group and high dose group at Month 12. measure: Difference in mean change from baseline in BCVA, as measured by ETDRS or tumbling "E" chart, in treated eyes versus control eyes in the low dose group and high dose group at Month 12. measure: Proportion of responding eyes in treated versus control eyes in the low dose group and high dose group at Month 12 where responder is defined as a 10-letter vision gain as measured by ETDRS or tumbling "E" chart. measure: Difference in mean change from baseline in the EZ area, as measured by SD-OCT, in treated eyes versus control eyes in the low dose group and high dose group at Month 12 Visit. measure: Mean change from baseline in Impact of Vision Impairment (IVI) (Weih et al, 2002; Lamoureaux et al, 2007) or Impact of Vision Impairment for Children (IVI-C) (Cochrane et al, 2008) in the low dose group and high dose group at Month 12 Visit measure: Mean change from baseline in Patient Global Impressions of Change (PGI-C) and Patient Global Impressions of Severity (PGIS) in the low dose group and high dose group at Month 12 Visit. sex: MALE minimumAge: 8 Years maximumAge: 50 Years stdAges: CHILD stdAges: ADULT facility: University of Florida city: Jacksonville state: Florida zip: 32209 country: United States lat: 30.33218 lon: -81.65565 facility: Boston Children's Hosptial city: Boston state: Massachusetts zip: 02115 country: United States lat: 42.35843 lon: -71.05977 facility: Cincinnati Eye Institute city: Cincinnati state: Ohio zip: 45242 country: United States lat: 39.12713 lon: -84.51435 facility: Cleveland Clinic city: Cleveland state: Ohio zip: 44195 country: United States lat: 41.4995 lon: -81.69541 facility: Casey Eye Institute city: Portland state: Oregon zip: 97239 country: United States lat: 45.52345 lon: -122.67621 facility: Retina Foundation of the Southwest city: Dallas state: Texas zip: 75231 country: United States lat: 32.78306 lon: -96.80667 hasResults: False
<\|newrecord\|> nctId: NCT06333236 id: OCU_KRON briefTitle: Effect of Kron (Citicoline and Nicotinamide Oral Solution) on Patients With Open-angle Glaucoma overallStatus: NOT_YET_RECRUITING date: 2024-03-25 date: 2024-09-30 date: 2024-11-30 date: 2024-03-27 date: 2024-03-27 name: ASST Santi Paolo e Carlo class: OTHER briefSummary: Aim of this study is to investigate the administration effects of the combination of citicoline 40mg/ml and nicotinamide 15mg/ml oral solution (Kron®) on short term improvement in inner retinal function, bioelectrical activity of the visual cortex and visual function. conditions: Glaucoma studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: Food for Special Medical Purposes: Kron® measure: Electrofunctional evaluation measure: VF and SD-OCT sex: ALL minimumAge: 40 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06333223 id: LSC 23/ 396 briefTitle: Polyphenols and Probiotics to Improve Menopausal Symptoms Via the Gut-Brain Axis acronym: SYMPTOGUT overallStatus: RECRUITING date: 2024-03-18 date: 2024-12-18 date: 2025-03-30 date: 2024-03-27 date: 2024-03-29 name: University of Roehampton class: OTHER name: King's College briefSummary: Menopause is one of the most significant lifecourse challenges for women. The decline in female sex hormones, in particular estrogen, during menopause leads to an increased risk in cardiometabolic diseases, and a decrease in quality of life due to symptoms such as low mood, anxiety, hot flushes and difficulty sleeping. As life expectancy continues to increase, on average, women will spend one third of their life in the postmenopausal period. Increasing evidence suggests that the gut microbiota plays a key role in menopause-related symptoms and conditions, being one of the main regulators of circulating sex hormones. Menopause has been linked to gut dysbiosis and lower gut microbial diversity, therefore nutritional strategies targeting the gut microbiome may be an effective approach to improve women's health during menopause. Both (poly)phenols and probiotics are promising candidates for the prevention and treatment of menopausal symptoms via different mechanisms, including the modulation of the gut-brain axis, while emerging evidence indicates that using both together may be a better approach than traditional carbohydrate-based synbiotics.
To our knowledge, the efficacy of a (poly)phenol based synbiotic targeting the gut microbiome for improvement of menopausal symptoms has not been investigated so far. conditions: Menopause studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Arm 1: Mixture of (Poly)phenols and a probiotic supplement Arm 2: (Poly)phenols and maltodextrin (placebo) primaryPurpose: OTHER masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: Mixture of (Poly)phenols and a probiotic supplement name: Placebo comparator measure: Change in blood chemistry levels measure: Change in BMI (body mass index) Scores measure: Change in the gut microbiota diversity measure: Change in dietary habits measure: Change in Quality IPAQ measure: Change in inflammatory biomarkes sex: FEMALE minimumAge: 48 Years maximumAge: 60 Years stdAges: ADULT facility: Health Sciences Research Centre, Life Sciences Department, University of Roehampton status: RECRUITING city: London state: UK zip: SW15 4JD country: United Kingdom name: Adele Costabile role: CONTACT lat: 51.50853 lon: -0.12574 facility: Adele Costabile status: RECRUITING city: London zip: SW145JD country: United Kingdom name: Adele Costabile, Prof role: CONTACT name: Zicheng Zhang role: PRINCIPAL_INVESTIGATOR lat: 51.50853 lon: -0.12574 hasResults: False
<\|newrecord\|> nctId: NCT06333210 id: BCD-180-3 briefTitle: Study of the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of BCD-180 in Patients With Axial Spondyloarthritis (LEVENTA) overallStatus: RECRUITING date: 2023-12-25 date: 2024-12 date: 2028-02 date: 2024-03-27 date: 2024-03-27 name: Biocad class: INDUSTRY briefSummary: The aim of the study is to evaluate the efficacy, safety, immunogenicity, pharmacokinetics and pharmacodynamics of a fixed dose of study drug (BCD-180) in comparison with placebo in patients with active axial spondyloarthritis (axSpA). The study will include HLA-B27+ patients with radiographic (r-axSpA) and non-radiographic (nr-axSpA) who had no response to prior therapy with non-steroidal anti-rheumatic drugs (NSAIDs), have not received biologic disease-modifying anti-rheumatic drugs (bDMARDs) or targeted synthetic disease-modifying antirheumatic drugs (tsDMARDs), and subjects with insufficient efficacy and/or loss of efficacy on bDMARDs and/or tsDMARDs. conditions: Axial Spondyloarthritis studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 421 type: ESTIMATED name: anti-TRBV9 monoclonal antibody infusions name: Placebo infusions name: Adalimumab subcutaneous injection name: Placebo subcutaneous injection measure: Proportion of subjects who achieved ASAS40 among bDMARDs and tsDMARD-naive subjects measure: Proportion of subjects who achieved ASAS40 among bDMARDs and/or tsDMARD-experienced subjects measure: Proportion of subjects who achieved ASAS40 among subjects with r-axSpA measure: Proportion of subjects who achieved ASAS40 among subjects with nr-axSpA measure: Proportion of subjects with the ASDAS-CRP <1.3 measure: Proportion of subjects with the ASDAS-CRP ≥1.3 - <2.1 measure: Proportion of subjects with the ASDAS-CRP ≥2.1 - ≤3.5 measure: Proportion of subjects with the ASDAS-CRP >3.5 measure: Proportion of subjects who achieved ASDAS-CII (clinically important improvement) measure: Proportion of subjects who achieved ASDAS-MI (Major improvement) measure: ASDAS-CRP change from baseline measure: Proportion of patients who achieved clinical response defined as an improvement of BASDAI by at least 50% compared to baseline measure: Change from baseline in BASDAI measure: Proportion of subjects who achieved ASAS40 measure: Proportion of subjects who achieved ASAS20 measure: Proportion of subjects who achieved ASAS5/6 measure: Proportion of subjects who achieved ASAS partial remission measure: Change from baseline in BASMI measure: Change from baseline in BASFI measure: Change from baseline in the swollen joint count (44 joints) measure: Change from baseline in MASES measure: Change from baseline in overall back pain severity (BASDAI No. 2) measure: Change from baseline in nocturnal back pain severity measure: Change in the patient global assessment of disease activity from baseline measure: Change in the quality of life score assessed with EQ-5D-3L questionnaire from baseline measure: Change from baseline in SF-36 Physical Functioning compared to baseline measure: Change from baseline in SF-36 Mental Health compared to baseline measure: Change in the WPAI score from baseline measure: Change in the ASAS HI score from baseline measure: Change in the concentration of hsCRP from baseline measure: Change in ESR from baseline measure: Changes in the SPARCC score (spine, SIJ) from baseline measure: Changes in mSASSS scores from baseline measure: Proportion of subjects with adverse events measure: Proportion of subjects with serious adverse events measure: Proportion of subjects with grade 3 or higher adverse events according to CTCAE 5.0 measure: Proportion of subjects prematurely withdrawn from the study due to adverse events sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Chelyabinsk Regional Clinical hospital status: RECRUITING city: Chelyabinsk country: Russian Federation name: Olga Nesmeianova, PhD role: CONTACT phone: +73517493727 email: chelokb@mail.ru lat: 55.15402 lon: 61.42915 facility: State Budgetary Higher Vocational Education Institution I.M. Sechenov First Moscow State Medical University status: RECRUITING city: Moscow country: Russian Federation name: Sergey Moiseev, PhD, Doc Med Sci role: CONTACT phone: +7 499 248 25 44 email: clinpharm@mtu-net.ru lat: 55.75222 lon: 37.61556 facility: Clinical Rheumatology Hospital №25 status: RECRUITING city: Saint Petersburg country: Russian Federation name: Inna Gaidukova role: CONTACT phone: +7 (812) 670 30 90 email: b25@zdrav.spb.ru lat: 59.93863 lon: 30.31413 facility: North-Western State Medical University n.a. I.I.Mechnikov status: RECRUITING city: Saint-Petersburg country: Russian Federation name: Vadim Mazurov, PhD role: CONTACT lat: 59.93863 lon: 30.31413 hasResults: False
<\|newrecord\|> nctId: NCT06333197 id: Mandibular condylar fracture briefTitle: Approaches for Open Reduction and Internal Fixation of Mandibular Condylar Fracture overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-03-01 date: 2025-07-01 date: 2024-03-27 date: 2024-03-28 name: Assiut University class: OTHER briefSummary: The condylar region is the most frequent anatomical site for mandibular fractures .
Condylar fractures constitute 25.5% to 35.5% of all mandibular fractures. The mandibular condyle fracture is a type of fracture that affects the condyle, which is the knuckle-like projection of the mandible (lower jaw) that articulates with the temporal bone to form the temporomandibular joint (TMJ). conditions: Mandibular Fractures studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: ALL Patients diagnosed with Extra Capsular Fracture of Mandibular Condyle amenable for surgery. primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: ORIF through transparotid approach name: ORIF through retroparotid approach measure: Facial nerve injury measure: Operative time measure: Fracture stability measure: Mouth opening measure: Other Complication related to the Approach sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06333184 id: 3085-4215 briefTitle: Smoothies and Blood Sugars overallStatus: RECRUITING date: 2024-03-20 date: 2024-08-31 date: 2024-12-31 date: 2024-03-27 date: 2024-03-27 name: University of Bath class: OTHER briefSummary: Glycaemic responses to fruit smoothies may depend on the food matrix (e.g., degree of processing and physical structure), ingestion rate, dose ingested and fibre content. Furthermore, the method of sampling could alter inferences. The aim of this project is to characterise how these factors affect the glycaemic response to a commercially available fruit smoothie. Participants will ingest 7 different test drinks in a randomised, crossover design with fingerstick capillary blood sampling alongside continuous glucose monitors. Test drinks will include a glucose reference (CONTROL), the commercial product matched for carbohydrate to CONTROL (PRODUCT), equivalent carbohydrate ingested as whole fruits (WHOLE), equivalent carbohydrate ingested as blended fruits (WHOLE), equivalent carbohydrate as the commercial product ingested slowly (SLOW), equivalent carbohydrate as the commercial product ingested with additional fibre (FIBRE), and the commercial product ingested in a dose typically bought (DOSE). These data will provide insight into how the food matrix and different patterns of ingestion can alter the glycaemic response to a fruit smoothie, and how the measurement method may alter interpretations. conditions: Metabolic Disturbance studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: BASIC_SCIENCE masking: NONE count: 15 type: ESTIMATED name: Food measure: Glycaemic index of product with capillary vs CGM measure: Glycaemic index of all conditions with capillary vs CGM measure: Condition-by-sampling interaction measure: GI of products in capillary samples measure: GI of products in continuous glucose monitors measure: Peak glucose capillary vs CGM measure: Time to peak glucose capillary vs CGM sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department for Health, University of Bath status: RECRUITING city: Bath zip: BA2 7AY country: United Kingdom name: Javier T Gonzalez, PhD role: CONTACT phone: +44 (0) 1225 38 phoneExt: 5125 email: j.t.gonzalez@bath.ac.uk lat: 51.3751 lon: -2.36172 hasResults: False
<\|newrecord\|> nctId: NCT06333171 id: 00003872 briefTitle: 4-aminopyridine for Skin Wound Healing overallStatus: NOT_YET_RECRUITING date: 2024-07 date: 2027-09 date: 2028-03 date: 2024-03-27 date: 2024-03-27 name: John Elfar class: OTHER briefSummary: Many patients suffer from chronic non-healing wounds as well as acute wounds. There is a need to develop treatments to accelerate and improve healing of chronic and acute wounds. More research is needed to evaluate the role of 4-aminopyridine (4-AP), a promising new agent with an excellent safety profile, on wound healing. The investigational treatment will be used to evaluate the role of (4-AP) on the treatment of wounds to accelerate wound healing in healthy adults.
The purpose of this study is to evaluate the role of 4-AP on the treatment of wounds to accelerate healing.
The investigational treatment will be used to test the hypothesis that 4-AP can speed wound healing. conditions: Wounds conditions: Wound of Skin conditions: Wound Heal conditions: Wounds and Injuries studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is a double-blind, randomized, placebo-controlled trial design. primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Subjects in both aims will be assigned to Group A or Group B using a randomization scheme. Each study participant for each aim is randomly assigned to either treatment of placebo using permuted block randomization whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 68 type: ESTIMATED name: 4-Aminopyridine name: Placebo measure: Return of skin integrity and wound closure after skin punch biopsy measure: The effect of 4-AP on the hair number and growth at the skin punch biopsy site. sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Arizona city: Tucson state: Arizona zip: 85724 country: United States name: Andrea Horne role: CONTACT phone: 520-626-6456 email: ahh@arizona.edu lat: 32.22174 lon: -110.92648 hasResults: False
<\|newrecord\|> nctId: NCT06333158 id: AmWaRO Study briefTitle: Extracts of Amla, Walnut Leaf, Red Yeast Rice and Olive in Cardiovascular Prevention acronym: AmWaRO overallStatus: RECRUITING date: 2024-03-01 date: 2024-09 date: 2024-12 date: 2024-03-27 date: 2024-03-27 name: Nina Hermans class: OTHER name: University Hospital, Antwerp briefSummary: The aim of this study is to evaluate whether the use of a commercially available standardized combination preparation (Cholesfytol NG®), containing extracts of amla, walnut leaf, red yeast rice and olive, in individuals with hypercholesterolemia
1. Leads to a clinically relevant reduction of cholesterol levels, especially LDL,
2. Leads to a clinically relevant reduction of blood pressure on the short term,
3. Leads to a change in oxidative stress biomarkers.
Participants will be stratified by sex before randomization to one of the two treatments for 8 weeks:
* Cholesfytol NG: 500 mg Amla dry extract, 50 mg Walnut leaf dry extract, 33.6 mg Red yeast rice powder (equivalent to 1.45 mg monacolins), 25 mg Olive dry extract (equivalent to 5 mg of hydroxytyrosol) per day
* Placebo All treatments have an identical shape and color and should be used in the same way (oral intake; 3 capsules/day during dinner). No dietary instructions are given and participants are asked not to change their dietary habits, not to start other therapies (medication, supplements, slimming diets, extra physical activity, etc.) during their study period. Standardized questionnaires are used to obtain information on demographics, dietary habits and side effects. At baseline and after 8 weeks, 27 ml blood is drawn for various biological analyses, and blood pressure, BMI and waist circumference are measured. conditions: Low-Density-Lipoprotein-Type [LDL] Hyperlipoproteinemia studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 36 type: ESTIMATED name: Cholesfytol NG name: Placebo measure: Change from baseline LDL cholesterol at 8 weeks measure: Frequency of side effects (+ their burden) as reported in the final questionnaire measure: Change from baseline Blood Pressure, Systolic at 8 weeks measure: Change from baseline Blood Pressure, diastolic at 8 weeks measure: Change from baseline total cholesterol level at 8 weeks measure: Change from baseline HDL cholesterol level at 8 weeks measure: Change from baseline non-HDL cholesterol level at 8 weeks measure: Change from baseline Remnant Cholesterol at 8 weeks measure: Change from baseline triglycerides level at 8 weeks measure: Change from baseline Apo A1 level at 8 weeks measure: Change from baseline Apo B level at 8 weeks measure: Change from baseline lipoprotein A (LP(a)) level at 8 weeks measure: Change from baseline OxLDL level at 8 weeks measure: Change from baseline malondialdehyde (MDA) level at 8 weeks measure: Change from baseline glutathion (GSH) level at 8 weeks measure: Change from baseline glucose level at 8 weeks measure: Change from baseline HbA1c level at 8 weeks measure: Change from baseline insuline level at 8 weeks measure: Change from baseline Body Mass Index (BMI) at 8 weeks measure: Change from baseline waist circumference at 8 weeks measure: Change from baseline hemoglobine level at 8 weeks measure: Change from baseline creatinine level at 8 weeks measure: Change from baseline hs-CRP level at 8 weeks measure: Change from baseline homocysteine level at 8 weeks measure: Change from baseline creatine kinase (CK) level at 8 weeks measure: Change from baseline C-peptide level at 8 weeks sex: ALL minimumAge: 18 Years maximumAge: 76 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UAntwerp, NatuRAPT status: RECRUITING city: Wilrijk state: Antwerp zip: 2610 country: Belgium name: Nina Hermans, Prof. role: CONTACT phone: 003232652732 email: nina.hermans@uantwerpen.be lat: 51.16734 lon: 4.39513 hasResults: False
<\|newrecord\|> nctId: NCT06333145 id: EDRA briefTitle: ED90 of Remimazolam Anesthesia Induction in Drug-induced Sleep Endoscopy in Adults overallStatus: RECRUITING date: 2024-02-04 date: 2024-12-31 date: 2024-12-31 date: 2024-03-27 date: 2024-03-27 name: Tongji Hospital class: OTHER briefSummary: Exploring the ED90 of remimazolam in Drug-induced Sleep Endoscopy in adults at different BMI groups. conditions: Effect of Drug studyType: INTERVENTIONAL phases: PHASE4 allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 110 type: ESTIMATED name: Remimazolam measure: Ramsey Sedation Scale measure: Time records measure: Use of drugs measure: Respiratory suppression incidence measure: Incidence of Treatment-Emergent Adverse Events measure: Incidence of PACU Adverse Reactions sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tongji Hospital status: RECRUITING city: Wuhan state: Hubei zip: 430000 country: China name: aijun xu, Dr. role: CONTACT phone: 027-83663173 email: ajxu@tjh.tjmu.edu.cn name: yuan Bi, Dr. role: CONTACT phone: 027-18972718216 email: 18972718216@163.com lat: 30.58333 lon: 114.26667 hasResults: False
<\|newrecord\|> nctId: NCT06333132 id: DiabEAT.it briefTitle: Deciphering the Role of Incretin Hormones in Weight Loss-induced Remission of Type 2 Diabetes (DIABeat) acronym: DiabEATit overallStatus: NOT_YET_RECRUITING date: 2024-09-01 date: 2025-09-01 date: 2026-02-01 date: 2024-03-27 date: 2024-03-27 name: Azienda Ospedaliero, Universitaria Pisana class: OTHER briefSummary: The goal of this mechanistic study is to investigate the role of incretin hormones on weight loss-induced type 2 diabetes remission. conditions: Obesity conditions: Diabetes Mellitus Type 2 in Obese studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 45 type: ESTIMATED name: Weight loss-induced Diabetes Remission measure: Number of participants with incretin effect's restoration after achieving weightloss-induced diabetes remission measure: Rate of sustained weightloss-induced diabetes remission assessed by 2 consecutive HbA1c <48mmol/mol within 6 months sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Azienda Ospedaliero-Universitaria Pisana city: Pisa state: PI zip: 56127 country: Italy lat: 43.70853 lon: 10.4036 hasResults: False
<\|newrecord\|> nctId: NCT06333119 id: 72867572-050.01.04-320 briefTitle: The Relationship Between Urinary Incontinence and Motor Symptoms overallStatus: COMPLETED date: 2023-09-01 date: 2024-01-31 date: 2024-02-15 date: 2024-03-27 date: 2024-03-27 name: Pinar Yasar class: OTHER briefSummary: There is no study in the literature examining the relationship between urinary incontinence and motor symptoms in individuals with stroke. The aim of this study is to determine the relationship between urinary incontinence and spasticity, balance and walking, which negatively affect quality of life and functional performance after stroke. conditions: Stroke conditions: Urinary Incontinence conditions: Motor Skills Disorders studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 46 type: ACTUAL name: modified rankin scale measure: relationship with between urinary incontinence and motor symptoms sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Suleyman Demirel University city: Isparta country: Turkey lat: 37.76444 lon: 30.55222 hasResults: False
<\|newrecord\|> nctId: NCT06333106 id: FICUS - 2024/16FEV/077 briefTitle: PoCUS Diagnostic Accuracy for Fecal Impaction in the Emergency Department: A Prospective Study overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2024-12-31 date: 2024-12-31 date: 2024-03-27 date: 2024-04-29 name: Cliniques universitaires Saint-Luc- Université Catholique de Louvain class: OTHER name: Université de Liège name: Grand Hôpital de Charleroi name: Clinique Saint-Jean, Bruxelles name: Clinique Saint Pierre Ottignies briefSummary: Many medical and paramedical specialties regularly use point-of-care ultrasound (PoCUS) in clinical practice. The diagnosis of fecal impaction is quite common in the elderly living in nursing homes with a prevalence of 47.3%. Fecal impaction remains a major source of morbidity, while its etiology is often multifactorial and its diagnosis challenging. Current recommendations for the diagnosis of fecal impaction support the use of plain abdominal x-rays. PoCUS is a non-irradiating procedure and a clinical diagnostic tool that can be used in a variety of ways during abdominal examinations. Most scientific societies encourage the use of PoCUS to respond to a specific clinical question rather than to provide a diagnosis, which is usually confirmed by conventional ultrasound. However, the combination of physical examination and PoCUS may improve the diagnostic approach. This multicentric prospective study protocol aims to evaluate the diagnostic accuracy of PoCUS in patients aged 75 years or older with suspected fecal impaction in the emergency department compared with plain abdominal x-ray (or abdominal CT scan if required as part of the emergency department investigations). conditions: Fecal Impaction of Colon studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 247 type: ESTIMATED name: POCUS diagnostic value measure: Evaluation of the diagnostic value of clinical ultrasound in the diagnosis of fecal impaction in the emergency room measure: Influence of BMI on the diagnosis of fecal impaction at PoCUS measure: Influence of bladder repletion on the diagnosis of fecal impaction using PoCUS measure: Influence of patient echogenicity on the diagnosis of fecal impaction using PoCUS sex: ALL minimumAge: 75 Years maximumAge: 130 Years stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06333093 id: NL82178.018.22 briefTitle: Duodenal tIssue ResEction aCquisiTion (DIRECT) Study acronym: DIRECT overallStatus: RECRUITING date: 2023-01-10 date: 2024-06-01 date: 2024-06-01 date: 2024-03-27 date: 2024-03-27 name: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) class: OTHER briefSummary: To evaluate the quality of cold snare resection specimens of duodenal mucosa tissue in patients undergoing an upper gastrointestinal interventional endoscopy in order to improve the processing of histological samples and its assessment in general and for future duodenal ablation studies. conditions: Duodenum Disease studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 30 type: ESTIMATED name: Cold snare measure: Acquiring larger pieces of tissue from the duodenum measure: Histopatholocial assessment of larger pieces of tissue from the duodenum measure: Checking if the tissue is of good quality enough for single cell RNA sequencing sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Amsterdam UMC status: RECRUITING city: Amsterdam state: North-Holland zip: 1105 AZ country: Netherlands name: Celine BE Busch, MD role: CONTACT phone: +31621357593 email: diabetes-onderzoek@amsterdamumc.nl name: Jacques JG Bergman, MD PhD role: PRINCIPAL_INVESTIGATOR name: Celine BE Busch, MD role: SUB_INVESTIGATOR lat: 52.37403 lon: 4.88969 hasResults: False
<\|newrecord\|> nctId: NCT06333080 id: N-20220017 briefTitle: The Effect of Adherence to Oral Semaglutide on Glycaemic Control in People With Type 2 Diabetes Treated With Metformin acronym: DIACRON overallStatus: RECRUITING date: 2024-05-01 date: 2025-03 date: 2025-03 date: 2024-03-27 date: 2024-03-27 name: Aalborg University Hospital class: OTHER briefSummary: The objective of the trial is to investigate the effect of adherence to oral semaglutide dosing instructions on glycaemic control in people with type 2 diabetes, which are dysregulated on metformin and naïve to second line antidiabetic treatment. conditions: Diabetes Mellitus, Type 2 studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 20 type: ESTIMATED measure: Time-in-Range (TIR) measure: Pre-dose Fasting measure: Post-dose Fasting measure: Occurrence of nausea or vomiting measure: Water Intake at Dosing Time measure: Treatment-Related Impact Measure for Diabetes (TRIM-D) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Steno Diabetes Center North Denmark status: RECRUITING city: Aalborg zip: 9000 country: Denmark name: Mette Pilegaard Rasmussen, BSc role: CONTACT phone: 00 45 30 36 46 84 email: mpr@rn.dk name: Peter Vestergaard, MD role: PRINCIPAL_INVESTIGATOR name: Nynne S Holdt-Caspersen, MSc role: SUB_INVESTIGATOR lat: 57.048 lon: 9.9187 hasResults: False
<\|newrecord\|> nctId: NCT06333067 id: Sofwave21 briefTitle: Treatment to Lift Facial Lax Skin and Improve Facial Wrinkles Using Precise and Lift Applicators overallStatus: RECRUITING date: 2023-10-11 date: 2024-10-01 date: 2024-11-01 date: 2024-03-27 date: 2024-03-27 name: Sofwave Medical LTD class: INDUSTRY briefSummary: Open-label, non-randomized single-arm prospective, multi-center, self-controlled clinical study with masked evaluation. conditions: Lax Skin studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 100 type: ESTIMATED name: Sofwave measure: Primary Outcome Measure sex: ALL minimumAge: 35 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Costal Skin & Eye Institute status: RECRUITING city: La Mesa state: California zip: 91942 country: United States name: Christopher V.Crosby, MD role: CONTACT email: research@coastalskineye.com name: Christopher V.Crosby, MD role: PRINCIPAL_INVESTIGATOR lat: 32.76783 lon: -117.02308 facility: Skin Wellness Dermatology Associates status: RECRUITING city: Durham state: North Carolina zip: 27713 country: United States name: Talasia Smith role: CONTACT phone: 919-294-9440 email: cst@skinwellnessdermatology.com name: Brooke Jackson, MD role: PRINCIPAL_INVESTIGATOR lat: 35.99403 lon: -78.89862 hasResults: False
<\|newrecord\|> nctId: NCT06333054 id: NCLIN0091/ 14ct/mp37li briefTitle: Safety and Efficacy of a Head Lice Shampoo overallStatus: COMPLETED date: 2014-10-13 date: 2015-06-08 date: 2015-06-08 date: 2024-03-27 date: 2024-03-27 name: Oystershell NV class: INDUSTRY briefSummary: This study is designed to compare the effectiveness and safety of test head lice shampoo (Test product) versus Goldgeist® Forte (reference product) following two applications. conditions: Head Lice studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: INVESTIGATOR count: 109 type: ACTUAL name: Pyrethrum Extract name: Silcap Shampoo measure: Cure Rate superior to 70% for the test product measure: Cure Rate superior to 70% for the reference product measure: Superior cure rate to the reference measure: Non-inferiority rate to the reference measure: Local tolerability measure: Global tolerability measure: Skin irritation assessment measure: Eye irritation assessment measure: Esthetical effect of the anti-lice products measure: Adverse Events (AEs) measure: Severity of the lice infestation sex: ALL minimumAge: 1 Year stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: CardioSec Clinical Research GmbH city: Erfurt zip: 99084 country: Germany lat: 50.9787 lon: 11.03283 hasResults: False
<\|newrecord\|> nctId: NCT06333041 id: 32977-01-00 briefTitle: Study of Cannabidiol in Sanfilippo Syndrome overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-01 date: 2027-05 date: 2024-03-27 date: 2024-04-19 name: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center class: OTHER briefSummary: The goal of this clinical trial is to test cannabidiol in Sanfilippo syndrome. The main questions it aims to answer are: 1) determine the safety of cannabidiol in Sanfilippo syndrome, and 2) explore the efficacy of cannabidiol in treating the neurobehavioral symptoms and functional outcomes of Sanfilippo syndrome.
Each participant's caregiver will be asked to complete surveys related to the participant's behavior, mood, sleep, stooling, pain, and caregiver stress intermittently throughout the study. All participants will be enrolled into one of two cohorts based on enrollment order:
1. Sentinel Safety Cohort (first 5 participants) - all participants treated with Epidiolex (cannabidiol)
2. Controlled Cohort (next 30 participants) - participants randomized 1:1 (equal chance) to start treatment with Epidiolex (cannabidiol) or placebo for 16 weeks, followed by an 8-week washout period (no treatment). Participants then switch to the opposite treatment group for 16 weeks followed by all participants treated for 52 weeks with Epidiolex (cannabidiol). conditions: Sanfilippo Syndrome conditions: Mucopolysaccharidosis III studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Double-blind, placebo-controlled, cross-over study primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 35 type: ESTIMATED name: Epidiolex name: Placebo measure: Sanfilippo Behavior Rating Scale (SBRS)- mood/anger/aggression score sex: ALL minimumAge: 4 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center city: Torrance state: California zip: 90502 country: United States name: Cristi Williams role: CONTACT email: cristi.williams@lundquist.org name: Lynda Polgreen, MD, MS role: PRINCIPAL_INVESTIGATOR lat: 33.83585 lon: -118.34063 hasResults: False
<\|newrecord\|> nctId: NCT06333028 id: 938 briefTitle: A Study to Evaluate the enVista® Aspire (EA) Intraocular Lens in Subjects Undergoing Cataract Extraction overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-09 date: 2024-09 date: 2024-03-27 date: 2024-04-29 name: Bausch & Lomb Incorporated class: INDUSTRY briefSummary: A Study to Evaluate the enVista® Aspire (EA) intraocular lens in Subjects Undergoing Cataract Extraction conditions: Cataract studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: enVista Aspire EA IOLs measure: Mean binocular BCDVA (logMAR) at Visit 1 sex: ALL minimumAge: 22 Years stdAges: ADULT stdAges: OLDER_ADULT facility: SITE 104 city: Dover state: New Jersey zip: 07801 country: United States lat: 40.88399 lon: -74.5621 facility: Site 105 city: Woodland Park state: New Jersey zip: 07424 country: United States lat: 40.88982 lon: -74.19487 facility: Site 103 city: Garden City state: New York zip: 11530 country: United States lat: 40.72677 lon: -73.6343 facility: Site 106 city: Charleston state: South Carolina zip: 29407 country: United States lat: 32.77657 lon: -79.93092 facility: Site 101 city: Sugar Land state: Texas zip: 77478 country: United States lat: 29.61968 lon: -95.63495 facility: Site 102 city: Mount Pleasant state: Wisconsin zip: 53405 country: United States lat: 42.69743 lon: -87.85577 hasResults: False
<\|newrecord\|> nctId: NCT06333015 id: 924 briefTitle: Study to Evaluate the Safety and Effectiveness of the enVista® Beyond (EY) EDF Intraocular Lens in Subjects Undergoing Cataract Extraction overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-10 date: 2025-10 date: 2024-03-27 date: 2024-04-29 name: Bausch & Lomb Incorporated class: INDUSTRY briefSummary: This research study is evaluating the safety and efficacy (performance) of the Bausch + Lomb enVista Beyond Hydrophobic Acrylic Extended Depth of Focus Intraocular Lens (IOL) in subjects who receive this IOL in both eyes. conditions: Cataract studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Approximately 224 subjects (448 eyes) will be enrolled in this study with plans to bilaterally implant approximately 112 subjects with each of the test and control IOLs. primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Subjects and designated postoperative evaluator(s) will be masked to the IOLs assigned. The Investigator implanting the IOL and designated site personnel will be unmasked to the treatment assignment for a subject. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 224 type: ESTIMATED name: enVista EY Beyond IOL name: TECNIS 1-Piece monofocal IOL measure: Mean Monocular Photopic Distance Corrected Intermediate Visual Acuity (DCIVA) of first implanted eyes at Post-Operative Visit 4. measure: Median Monocular Photopic Distance Corrected Intermediate Visual Acuity (DCIVA) of first implanted eyes at Post-Operative Visit 4. measure: Negative lens induced distance-corrected Depth of focus (D) at 0.20 logMAR of first implanted eyes at Post-Operative Visit 4. measure: Mean monocular best-corrected distance visual acuity (BCDVA) (logMAR) of first implanted eyes at Post-Operative Visit 4. measure: Rates with postoperative monocular BCDVA of 20/40 (0.30 logMAR) or better of first implanted eyes at Post-Operative Visit 4. measure: Mean monocular photopic distance-corrected near visual acuity (DCNVA) of first implanted eyes at Post-Operative Visit 4. sex: ALL minimumAge: 22 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Site 108 city: Northridge state: California zip: 91325 country: United States lat: 34.22834 lon: -118.53675 facility: Site 107 city: Bloomington state: Minnesota zip: 55420 country: United States lat: 44.8408 lon: -93.29828 facility: Site 101 city: Omaha state: Nebraska zip: 68137 country: United States lat: 41.25626 lon: -95.94043 facility: Site 109 city: Las Vegas state: Nevada zip: 89145 country: United States lat: 36.17497 lon: -115.13722 facility: Site 102 city: Brecksville state: Ohio zip: 44141 country: United States lat: 41.31978 lon: -81.62679 facility: Site 105 city: North Charleston state: South Carolina zip: 29406 country: United States lat: 32.85462 lon: -79.97481 facility: Site 106 city: Sioux Falls state: South Dakota zip: 57108 country: United States lat: 43.54997 lon: -96.70033 facility: Site 103 city: Dallas state: Texas zip: 75243 country: United States lat: 32.78306 lon: -96.80667 facility: Site 111 city: Mount Pleasant state: Wisconsin zip: 53405 country: United States lat: 42.69743 lon: -87.85577 facility: Site 110 city: Calgary state: Alberta zip: T2N 1N4 country: Canada lat: 51.05011 lon: -114.08529 facility: Site 104 city: Montréal state: Quebec zip: H1V 1G5 country: Canada lat: 45.50884 lon: -73.58781 hasResults: False
<\|newrecord\|> nctId: NCT06333002 id: PI24/00325 briefTitle: Machine Learning Model to Predict Outcome and Duration of Mechanical Ventilation in Acute Hypoxemic Respiratory Failure acronym: MEMORIAL overallStatus: ACTIVE_NOT_RECRUITING date: 2024-03-19 date: 2026-05-30 date: 2026-05-30 date: 2024-03-27 date: 2024-03-27 name: Dr. Negrin University Hospital class: OTHER briefSummary: Acute hypoxemic respiratory failure (AHRF) is the most common cause of admission in the intensive care units (UCIs) worldwide. We will assess the value of machine learning (ML) techniques for early prediction of ICU death and prolonged duration (\>7 days) of mechanical ventilation (MV) in 1,241 patients enrolled in the PANDORA (Prevalence AND Outcome of acute Respiratory fAilure) Study in Spain. The study was registered with ClinicalTrials.gov (NCT03145974). Our aim is to evaluate the minimum number of variables models using logistic regression and four supervised ML algorithms: Random Forest, Extreme Gradient Boosting, Support Vector Machine and Multilayer Perceptron. conditions: Acute Hypoxemic Respiratory Failure studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1241 type: ESTIMATED name: machine learning analysis measure: ICU mortality measure: MV duration sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital General Universitario de Ciudad Real city: Ciudad Real zip: 13005 country: Spain lat: 38.98626 lon: -3.92907 facility: Hospital Virgen de La Luz city: Cuenca zip: 16002 country: Spain lat: 40.06667 lon: -2.13333 facility: Hospital Universitario La Paz city: Madrid zip: 28046 country: Spain lat: 40.4165 lon: -3.70256 facility: Hospital Universitario Puerta de Hierro city: Madrid zip: 28222 country: Spain lat: 40.4165 lon: -3.70256 facility: Hospital Universitario Virgen de Arrixaca city: Murcia zip: 3012 country: Spain lat: 37.98704 lon: -1.13004 facility: Hospital Universitario NS de Candelaria city: Santa Cruz De Tenerife zip: 38010 country: Spain lat: 28.46824 lon: -16.25462 facility: Hospital Cinico de Valencia city: Valencia zip: 46010 country: Spain lat: 39.46975 lon: -0.37739 facility: Hospital Universitario Rio Hortega city: Valladolid zip: 47012 country: Spain lat: 41.65518 lon: -4.72372 hasResults: False
<\|newrecord\|> nctId: NCT06332989 id: N22.129 briefTitle: Stroke Triage Optimization by Ambulance Paramedics in the Pre-hospital Setting acronym: STROKE-APP overallStatus: RECRUITING date: 2024-02-01 date: 2027-02-01 date: 2027-02-01 date: 2024-03-27 date: 2024-03-27 name: Leiden University Medical Center class: OTHER name: Alrijne Ziekenhuis Leiderdorp name: Groene Hart Ziekenhuis name: Medical Center Haaglanden name: HagaZiekenhuis name: Reinier de Graaf Groep name: Regionale Ambulance Voorziening Hollands Midden briefSummary: There are everal scales designed to help ambulance paramedics to identify a patient with a stroke and activate a stroke code. These scales were never tested in the field in a large unselected patient sample. We aim to perform an in-the field head tot head comparison of all published stroke scales designed to be used by ambulance paramedics conditions: Stroke, Acute conditions: Pre-hospital Triage conditions: Stroke Treatment conditions: Stroke Code studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 3000 type: ESTIMATED name: stroke-APP measure: final diagnosis measure: treated with reperfusion therapy measure: additional investigations sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Leiden University medical center status: RECRUITING city: Leiden country: Netherlands name: Nyika D Kruyt, MD. PhD role: CONTACT phone: 0031-715262139 email: n.d.kruyt@lumc.nl lat: 52.15833 lon: 4.49306 hasResults: False
<\|newrecord\|> nctId: NCT06332976 id: IEO 1521 briefTitle: PrefeRences And ChemoTherapy In Breast Cancer patiEnts acronym: PRACTICE overallStatus: RECRUITING date: 2021-06-04 date: 2024-12-31 date: 2024-12-31 date: 2024-03-27 date: 2024-03-27 name: European Institute of Oncology class: OTHER briefSummary: The aim of the present study is to ask women treated with adjuvant or neoadjuvant chemotherapy for breast cancer what survival benefit would justify the treatment.
The benefit should be evaluated in terms of Survival rate trade off and Survival time trade off value. The analyses will be conducted into three different groups of patients to value the survival benefit expected:
1. before to start the chemotherapy
2. during chemotherapy
3. after the end of chemotherapy conditions: Female Breast Cancer studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 450 type: ESTIMATED name: Completion of questionnaires measure: Percentage of risk reduction needed to consider adjuvant or neoadjuvant chemotherapy worthwhile measure: Prolonged survival time gain needed to consider CT worthwhile measure: Behavior assessment measure: Reaction to uncertain situations assessment measure: Regret and disappointment assessment sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: European Institute of Oncology status: RECRUITING city: Milan zip: 20141 country: Italy name: Emilia Montagna, MD role: CONTACT phone: +390257489970 email: emilia.montagna@ieo.it lat: 45.46427 lon: 9.18951 hasResults: False
<\|newrecord\|> nctId: NCT06332963 id: 2023-007 briefTitle: Interoceptive Mechanisms of Body Image Disturbance in Anorexia Nervosa overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2028-06 date: 2028-12 date: 2024-03-27 date: 2024-03-27 name: Laureate Institute for Brain Research, Inc. class: OTHER briefSummary: The proposed study utilizes a randomized experimental therapeutics design to test a mechanistic framework linking interoceptive processing and disturbed body image, with the purpose of informing the development of future therapies for body image dissatisfaction in anorexia nervosa (AN). A sample of 102 participants will be recruited from the Laureate Eating Disorder Program (LEDP). After being randomized, participants will all receive a one-hour session of acceptance- and mindfulness-based training with a therapist (the introduction session). They will then receive either the interoceptively focused treatment (IFT) or exteroceptively focused treatment (EFT) condition based on randomization. In the IFT condition participants will engage in floatation-REST (Reduced Environmental Stimulation Therapy) while practicing acceptance and mindfulness-based principles. The EFT condition is an exteroceptive intervention in which participants will be asked to view pre-recorded videos of acceptance and mindfulness-based skills to aid in the practice of these skills. Each condition will consist of one introduction session and three experimental sessions. All participants will then return for follow-up measures. Assessed outcomes will include acute changes in body image disturbance (BID) and interoception. Further, longitudinal intervention effects on self-reported eating disorder symptoms, body image dissatisfaction, and interoception; behavioral measures of interoception and body image dissatisfaction; and resting state and interoceptive functioning during functional magnetic resonance imaging (fMRI) will be explored. conditions: Anorexia Nervosa conditions: Body Image Disturbance conditions: Interoception studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Equal groups parallel randomized clinical trial primaryPurpose: TREATMENT masking: NONE count: 102 type: ESTIMATED name: Floatation-REST name: IFT name: EFT measure: Perceptual body image dissatisfaction on the Photographic Figure Rating Scale (PFRS) measure: Perceptual body image dissatisfaction on the Photographic Figure Rating Scale (PFRS) measure: Cognitive/affective body image on the Body Image State Scale (BISS) measure: Body image dissatisfaction on the Somatomap3D measure: Appearance evaluation on the Multidimensional Body-Self Relations Questionnaire- Appearance Scales (MBSRQ-AS) Appearance Evaluation Subscale (range 7 to 35, higher scores indicate more satisfaction with appearance) measure: Appearance orientation on the Multidimensional Body-Self Relations Questionnaire- Appearance Scales (MBSRQ-AS) Appearance Orientation Subscale (range 7 to 35, higher scores indicate more satisfaction with appearance) measure: Body image satisfaction on the Multidimensional Body-Self Relations Questionnaire- Appearance Scales (MBSRQ-AS) Body Areas Satisfaction measure: Overweight preoccupation on the Multidimensional Body-Self Relations Questionnaire- Appearance Scales (MBSRQ-AS) Overweight preoccupation scale measure: Noticing on the Multidimensional Assessment of Interoceptive Awareness version 2 (MAIA-2) measure: Not distracting on the Multidimensional Assessment of Interoceptive Awareness version 2 (MAIA-2) measure: Not worrying on the Multidimensional Assessment of Interoceptive Awareness version 2 (MAIA-2) measure: Attention regulation on the Multidimensional Assessment of Interoceptive Awareness version 2 (MAIA-2) measure: Emotional awareness on the Multidimensional Assessment of Interoceptive Awareness version 2 (MAIA-2) measure: Self-regulation on the Multidimensional Assessment of Interoceptive Awareness version 2 (MAIA-2) measure: Trust on the Multidimensional Assessment of Interoceptive Awareness version 2 (MAIA-2) measure: Interoceptive attention on the Interoceptive Attention Scale (IATS) measure: Cardiac interoceptive accuracy on the Heartbeat Tapping Task measure: Cardiac interoceptive intensity on the Heartbeat Tapping Task measure: Interoceptive intensity during experimental conditions measure: Perceived respiratory interoceptive intensity on the Breath Hold Task measure: Body image distortion on the Aperture Task measure: Body image distortion on the String task sex: FEMALE minimumAge: 15 Years maximumAge: 40 Years stdAges: CHILD stdAges: ADULT hasResults: False
<\|newrecord\|> nctId: NCT06332950 id: MA-SCLC-II-015 briefTitle: Safety and Efficacy of Adebrelimab Plus Irinotecan Liposome (II) With or Without Famitinib in ES-SCLC Pre-treated With Immunotherapy overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2027-04-01 date: 2027-04-01 date: 2024-03-27 date: 2024-03-27 name: Baohui Han class: OTHER briefSummary: This is an open-label, randomized, multi-cohort, multi-center, phase Ib/II study to evaluate the safety and efficacy of Adebrelimab plus Irinotecan Liposome (II) with or without Famitinib in patients with extensive-stage small cell lung cancer (ES-SCLC) pre-treated with immune checkpoint inhibitor(s). conditions: Extensive-stage Small-cell Lung Cancer studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 80 type: ESTIMATED name: Adebrelimab, Irinotecan Liposome (II) name: Adebrelimab, Irinotecan Liposome (II), Famitinib measure: 6-month progression-free survival measure: Safety measure: Objective response rate measure: Progression-free survival measure: Overall survival measure: Disease control rate measure: Duration of response sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Shanghai Chest Hospital city: Shanghai country: China name: Baohui Han, M.D role: CONTACT email: 18930858216@163.com lat: 31.22222 lon: 121.45806 hasResults: False
<\|newrecord\|> nctId: NCT06332937 id: H-2102-079-1197 briefTitle: Breast Reconstruction overallStatus: ACTIVE_NOT_RECRUITING date: 2021-02-22 date: 2023-12-15 date: 2024-12-31 date: 2024-03-27 date: 2024-03-27 name: Seoul National University Hospital class: OTHER briefSummary: Complications following postmastectomy breast reconstruction can compromise surgical outcomes and lead to significant morbidity. The aim of this study was to determine factors associated with complication following two-stage implant-based reconstruction conditions: Breast Implant; Complications studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 5000 type: ESTIMATED name: postmastectomy breast reconstruction measure: Infection sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Seoul National University Hospital city: Seoul zip: 03080 country: Korea, Republic of lat: 37.566 lon: 126.9784 hasResults: False
<\|newrecord\|> nctId: NCT06332924 id: 2023/19 briefTitle: Primipara Pregnant Women and Motivational Interview overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-07-01 date: 2024-08-01 date: 2024-03-27 date: 2024-03-27 name: Saglik Bilimleri Universitesi class: OTHER briefSummary: The first birth is the most important moment a woman experiences in her life as she embarks on her motherhood journey. Waiting for the birth of a new life can be very exciting for mothers. Positive birth is an approach that asks the woman to approach her birth story from a positive perspective and to have a stronger, more impressive and positive birth experience. Primipara pregnant women especially benefit from and need this positive birth approach. Motivational interviews are interviews conducted to support positive births and to help women develop a positive attitude towards their birth experiences.
This planned study was planned as a randomized controlled trial with pre-test and post-test measurements, with the aim of determining the level of traumatic birth perception in primipara women who were given or not given training and examining the effects of positive birth motivational education by taking into account the need for education with numerical data. conditions: Pregnancy Related studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: In the project, it was calculated that the experimental and control groups should have at least 30 observations each, and the sample of the study was calculated as 60 pregnant women. It was aimed to interview a total of 60 pregnant women, 30 in the control group and 30 in the experimental group. primaryPurpose: PREVENTION masking: SINGLE whoMasked: PARTICIPANT count: 60 type: ESTIMATED name: motivational discussion group measure: Primipara Pregnant Women and Traumatic Birth sex: FEMALE minimumAge: 20 Years maximumAge: 35 Years stdAges: ADULT hasResults: False
<\|newrecord\|> nctId: NCT06332911 id: RO-231129 briefTitle: Shockwave™Peripheral Intravascular Lithotripsy Balloon for Advanced Endovascular Aortic Repair acronym: TEVAR overallStatus: NOT_YET_RECRUITING date: 2024-08-01 date: 2025-08-30 date: 2026-08-30 date: 2024-03-27 date: 2024-03-27 name: Rede Optimus Hospitalar SA class: NETWORK name: Shockwave Medical, Inc. briefSummary: Shockwave TEVAR is a nonrandomized, prospective, international, multi-center, PMCF, obervational study.
The aim of this study is to evaluate the outcomes of the Shockwave™ Peripheral Intravascular Lithotripsy Balloon (Shockwave Medical Inc.) in the routine treatment of hostile iliac accesses during TEVAR and F/BEVAR. conditions: Thoracoabdominal Aortic Aneurysm, Without Mention of Rupture conditions: Abdominal Aortic Aneurysm Without Rupture conditions: Thoracic Aortic Aneurysm Without Rupture studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 30 type: ESTIMATED name: Shockwave™ Peripheral Intravascular Lithotripsy Balloon M5+ measure: Efficacy: Technical success - defined as intention-to-treat basis sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06332898 id: AG-01-0324 briefTitle: The Effects of a Nutritional Supplement on Nutrient Status and Quality of Life overallStatus: NOT_YET_RECRUITING date: 2024-03-31 date: 2024-10-31 date: 2025-02-04 date: 2024-03-27 date: 2024-04-01 name: Athletic Greens International class: INDUSTRY name: Citruslabs briefSummary: This study is a randomized, double-blind, placebo-controlled study of N=120 apparently healthy men and women. The purpose of this study is to assess the effect of a novel dietary supplement on blood markers of nutrient status, gut microbiome, and overall quality of life. conditions: Nutrition, Healthy conditions: Gastrointestinal Microbiome conditions: Healthy Aging studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized, Double-Blind, Placebo Controlled Design primaryPurpose: OTHER masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 120 type: ESTIMATED name: AG1 - Nutritional Supplement name: Placebo measure: Homocysteine measure: Vitamin B12 measure: Folate measure: Red Blood Cell Folate measure: Zinc measure: Vitamin C measure: Gut Microbiome measure: Dietary habits measure: Gastrointestinal Health measure: Fatigue & energy measure: Well-being measure: Complete Metabolic Blood Panel measure: Complete Blood Count sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT hasResults: False
<\|newrecord\|> nctId: NCT06332885 id: 630-2001-01 briefTitle: Zephyr Valve Japan Post-Marketing Surveillance overallStatus: RECRUITING date: 2024-03-12 date: 2027-03-31 date: 2028-03-31 date: 2024-03-27 date: 2024-04-19 name: Pulmonx Corporation class: INDUSTRY briefSummary: This is a multicenter, prospective, observational surveillance enrolling 140 consecutive patients with severe emphysema who are candidates for bronchoscopic lung volume reduction using Zephyr Endobronchial Valve at up to 20 centers across Japan and followed for 12 months. conditions: Emphysema conditions: COPD conditions: Severe Emphysema studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 140 type: ESTIMATED name: Zephyr Endobronchial Valve measure: Incidence rate of pneumothorax at 45-days post-Zephyr Valve index procedure. measure: Forced Expiratory Volume in 1 second (FEV1) measure: Residual Volume (RV) measure: Treated lobe volume reduction (TLVR) measure: Six-Minute Walk Distance (6MWD) measure: Modified Medical Research Council Dyspnea (mMRC) Scale score measure: St. George's Respiratory Questionnaire (SGRQ) Total Score sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Gifu Prefectural Medical Center status: RECRUITING city: Gifu country: Japan name: Takahiro Masami role: CONTACT email: chiken-center.4289@gifu-hp.jp name: Fumihiro Asano, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 35.42291 lon: 136.76039 facility: Kanagawa Cardio Chest Center status: RECRUITING city: Kanagawa country: Japan name: Takashi Niwa, MD role: CONTACT email: wanikko0714@gmail.com name: Takashi Niwa, MD role: PRINCIPAL_INVESTIGATOR lat: 37.58333 lon: 139.91667 facility: Kanazawa University Hospital status: RECRUITING city: Kanazawa country: Japan name: Satoshi Watanabe, MD role: CONTACT email: swatanabe@staff.kanazawa-u.ac.jp name: Satoshi Watanabe, MD role: PRINCIPAL_INVESTIGATOR lat: 36.6 lon: 136.61667 facility: St Marianna University Hospital status: RECRUITING city: Kawasaki country: Japan name: Masamichi Mineshita, MD role: CONTACT email: m-mine@marianna-u.ac.jp name: Masamichi Mineshita, MD role: PRINCIPAL_INVESTIGATOR lat: 35.52056 lon: 139.71722 facility: Nagasaki University Hospital status: RECRUITING city: Nagasaki country: Japan name: Keitaro Matsumoto, MD role: CONTACT email: kmatsumo@nagasaki-u.ac.jp name: Keitaro Matsumoto, MD role: PRINCIPAL_INVESTIGATOR lat: 32.75 lon: 129.88333 facility: Nagoya Medical Center status: RECRUITING city: Nagoya country: Japan name: Masahide Oki, MD role: CONTACT email: masahideo@gmail.com name: Masahide Oki, MD role: PRINCIPAL_INVESTIGATOR lat: 35.18147 lon: 136.90641 facility: Okayama Medical Center status: RECRUITING city: Okayama country: Japan name: Yanagihara role: CONTACT email: okmc-iec@nifty.com name: Ken Sato, MD role: PRINCIPAL_INVESTIGATOR lat: 34.65 lon: 133.93333 facility: Kinki Chuo Chest Medical Center status: RECRUITING city: Osaka country: Japan name: Akihiro Tamiya, MD role: CONTACT email: tamiya.akihiro.tz@mail.hosp.go.jp name: Akihiro Tamiya, MD role: PRINCIPAL_INVESTIGATOR lat: 34.69374 lon: 135.50218 facility: Hokkaido University Hospital status: RECRUITING city: Sapporo country: Japan name: Naofumi Shinagawa, MD role: CONTACT email: naop.shinagawa@nifty.ne.jp name: Naofumi Shinagawa, MD role: PRINCIPAL_INVESTIGATOR lat: 43.06667 lon: 141.35 facility: Tohoku University Hospital status: RECRUITING city: Sendai country: Japan name: Hirotsugu Notsuda, MD role: CONTACT email: hirotsugu.notsuda.c4@tohoku.ac.jp name: Hirotsugu Notsuda, MD role: PRINCIPAL_INVESTIGATOR lat: 38.26667 lon: 140.86667 facility: Shiga University Hospital status: RECRUITING city: Shiga country: Japan name: Yasuki Uchida, MD role: CONTACT email: uchiy@belle.shiga-med.ac.jp name: Yasuki Uchida, MD role: PRINCIPAL_INVESTIGATOR facility: Tokyo National Hospital status: RECRUITING city: Tokyo country: Japan name: Hiroyuki Tashimo, MD role: CONTACT name: Hiroyuki Tashimo, MD role: PRINCIPAL_INVESTIGATOR lat: 35.6895 lon: 139.69171 facility: Fujita Health University Hospital status: RECRUITING city: Toyoake country: Japan name: Risako Koshiyama role: CONTACT email: gcpjim@fujita-hu.ac.jp name: Kazuyoshi Imaizumi, MD role: PRINCIPAL_INVESTIGATOR lat: 35.038 lon: 136.99931 facility: Dokkyo University Hospital (Pulmonary Medicine and Clinical Immunology) status: NOT_YET_RECRUITING city: Utsunomiya country: Japan name: Yasuo Shimizu, MD role: CONTACT email: yasuo-s@dokkyomed.ac.jp name: Yasuo Shimizu, MD role: PRINCIPAL_INVESTIGATOR lat: 36.56667 lon: 139.88333 facility: Dokkyo University Hospital status: RECRUITING city: Utsunomiya country: Japan name: Masayuki Chida, MD role: CONTACT email: chidaths@dokkyomed.ac.jp name: Masayuki Chida, MD role: PRINCIPAL_INVESTIGATOR lat: 36.56667 lon: 139.88333 hasResults: False
<\|newrecord\|> nctId: NCT06332872 id: M046q/66 briefTitle: Comparison Effectiveness of Oral Ivermectin , 1% Permethrin Shampoo and 4% Dimeticone Liquid Gel in the Treatment of Pediculosis Capitis Among School Children in Chachoengsao Province, Thailand overallStatus: ACTIVE_NOT_RECRUITING date: 2023-12-15 date: 2024-03-18 date: 2024-05 date: 2024-03-27 date: 2024-03-27 name: Phramongkutklao College of Medicine and Hospital class: OTHER briefSummary: The goal of this clinical trial is to Comparison effectiveness of Oral ivermectin , 1% Permethrin shampoo and 4% Dimeticone liquid gel in the treatment of Pediculosis capitis, to assess the prevalence of lice and associated risk factors between severity groups by using questionnaire-based surveys and diagnostic tests among school children in Baan Nayao, Chachoengsao Province, Thailand.
The main questions it aims to answer are
* What is more effective between Oral ivermectin , 1% Permethrin shampoo and 4%Dimeticone liquid gel in the treatment of Pediculosis capitis in school children in Baan Nayao, Chachoengsao Province, Thailand?
* What is Prevalence and risk factors of being infected with in head lice in school and community?
* What is Side effects of Oral ivermectin , 1% Permethrin shampoo and 4%Dimeticone liquid gel?
Participants will receive three different drugs are
* oral ivermectin
* 4% Dimeticone liquid gel
* 1% Permethrin shampoo
Participants voluntarily received oral ivermectin as per medical prescription, with treatment outcomes, side effects, and satisfaction levels monitored following two treatment cycles. Those exhibiting persistent lice infestations were subsequently treated with 1% permethrin shampoo, the standard treatment, while alternatives were provided for individuals allergic to permethrin. These findings will contribute to formulating tailored, effective, and safe treatment regimens for future patients. conditions: Pediculus Capitis Infestation conditions: Permethrin Adverse Reaction conditions: Dimethicone Adverse Reaction conditions: Permethrin Allergy conditions: Dimethicone Allergy conditions: Ivermectin conditions: School-age Children studyType: INTERVENTIONAL phases: PHASE4 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 117 type: ESTIMATED name: Oral Ivermectin name: 4% dimenticone liquid gel measure: Comparison effectiveness of Oral ivermectin , 1% Permethrin shampoo and 4% Dimeticone liquid gel in the treatment of Pediculosis capitis measure: Prevalence of head louse infestation among school children in Chachoengsao Province, Thailand measure: Side effects of Oral ivermectin , 1% Permethrin shampoo and 4%Dimeticone liquid gel measure: The association factor of head lice infestation among school children in Chachoengsao Province, Thailand sex: ALL minimumAge: 6 Years maximumAge: 13 Years stdAges: CHILD facility: Phramongkutklao college of medicine city: Bangkok country: Thailand lat: 13.75398 lon: 100.50144 hasResults: False
<\|newrecord\|> nctId: NCT06332859 id: FOR-0022 briefTitle: Effectiveness of a Resilience-Based Rehabilitation Program for Patients With Coronary Heart Disease overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2026-10-14 date: 2026-10-14 date: 2024-03-27 date: 2024-03-27 name: Pensionsversicherungsanstalt class: OTHER briefSummary: To handle daily life challenges, one needs to be psychologically resilient. It plays a crucial role in disease development, prognosis, as well as social, occupational, and community participation. Cardiovascular diseases cause physical and psychological stress, which can be linked to individual resilience and the development of such diseases. Stress can trigger TakoTsubo cardiomyopathy and acute coronary events. Individuals who have experienced TakoTsubo cardiomyopathy or an acute coronary event often feel stressed due to emotional or physical triggers. These triggers may include job loss or illness. In medical rehabilitation, therapists consider the individual circumstances of their patients when planning therapy. It may be important to add a special focus on psychological care, including building resilience, which could greatly benefit these individuals. Therefore, the study aims to investigate whether resilience training, as part of an inpatient multidisciplinary rehabilitation program, affects the individual resilience of rehabilitants with TakoTsubo cardiomyopathy or those who have experienced an acute coronary event. conditions: Takotsubo Cardiomyopathy conditions: Acute Coronary Syndrome conditions: Psychological Resilience studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 130 type: ESTIMATED name: Resilience training measure: Resilience scale-13 (RS-13) measure: Brief Resilience scale - German Version (BRS) measure: European Quality of Life 5 Dimensions 5 Level (EQ-5D-5L) measure: Patient Health Questionnaire-4 (PHQ-4) measure: Maximal incremental exercise test measure: Work ability index (WAI) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06332846 id: KB-0012/06/10 briefTitle: Oral Health in Patients Hospitalized Because of Ischemic Stroke overallStatus: COMPLETED date: 2019-10-10 date: 2021-11-15 date: 2023-12-10 date: 2024-03-27 date: 2024-03-27 name: Pomeranian Medical University Szczecin class: OTHER briefSummary: Maintaining good oral health is essential for general health and quality of life. Results of many anal-yses showed that stroke patients had poorer oral condition and worse periodontal status than control population. The aim of the study was to carry out a clinical observation concerning condition of oral health in stroke patients and healthy population.
The oral health was assessed in patients with stroke and in (control group). The following elements were assessed: missing teeth, the presence of active caries foci, the presence of existing fillings and prosthetic restorations. To assess oral hygiene API (Approximal Plaque Index) was used. As part of periodontal examina-tion, the following were assessed: the presence of dental deposits, the depth of the existing periodontal pockets, tooth mobility according to Hall and Sulcus Bleeding Index during probing (SBI). conditions: Oral Disease conditions: Stroke, Ischemic studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 118 type: ACTUAL name: oral examination name: oral examination measure: Oral health status measure: Oral hygiene assessment measure: Periodontal status- periodontal pockets measure: Periodontal status-tooth mobility measure: Periodontal status- bleeding sex: ALL minimumAge: 45 Years maximumAge: 89 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Pomeranian Medical University in Szczecin city: Szczecin zip: 70-111 country: Poland lat: 53.42894 lon: 14.55302 hasResults: False
<\|newrecord\|> nctId: NCT06332833 id: 235 briefTitle: Availability of Venous Conduits in Patients With Varicose Veins for Arterial Bypass Surgery overallStatus: RECRUITING date: 2023-12-01 date: 2024-05-31 date: 2024-05-31 date: 2024-03-27 date: 2024-03-27 name: Pirogov Russian National Research Medical University class: OTHER briefSummary: Patients with PAD having superficial femoral artery (SFA) occlusion were consecutively enrolled. Demographic data and medical history were taken. Physical examination and duplex ultrasound were performed. conditions: Varicose Veins conditions: Peripheral Arterial Disease studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 80 type: ESTIMATED measure: availability of saphenous trunks as possible grafts measure: presence of varicose veins measure: type of previous invasive procedure sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Veronika Golovina status: RECRUITING city: Moscow state: Pirogov Russian National Research Medical University zip: 109044 country: Russian Federation name: Veronika Golovina, MD, PHD role: CONTACT phone: +79776051708 email: nikuskin@inbox.ru lat: 55.75222 lon: 37.61556 hasResults: False
<\|newrecord\|> nctId: NCT06332820 id: 202401226RINB briefTitle: In Patients With Obstructive Airway Disease, Investigate the Effects of Different Breathing Strategies and Pedaling Rates on the Physiological Response to Bicycle Exercise overallStatus: ACTIVE_NOT_RECRUITING date: 2024-03-20 date: 2030-12-31 date: 2030-12-31 date: 2024-03-27 date: 2024-04-09 name: National Taiwan University Hospital class: OTHER briefSummary: The definition of obstructive airway disease is a ratio of the forced expiratory volume in one second (FEV1) to the forced vital capacity (FVC) of less than 0.7, which includes conditions such as chronic obstructive pulmonary disease, asthma, lymphangioleiomyomatosis, and bronchiolitis obliterans syndrome. For example, lung obstruction adversely affects many aspects of a patient's health, such as lung function and exercise capacity. Pulmonary rehabilitation is widely used in patients with obstructive airway disease, and the prescription of pulmonary rehabilitation depends on exercise capacity parameters such as peak oxygen uptake (peak VO2), peak workload, and anaerobic threshold. However, patients often have difficulty achieving training goals due to severe dyspnea during exercise. Dynamic hyperinflation is a common cause of dyspnea during exercise in patients with obstructive airway disease. Investigators aim to alleviate breathlessness by reducing dynamic hyperinflation, making it easier to achieve training goals. Methods to reduce dynamic hyperinflation include pursed lip breathing, reducing breathing rate to prolong expiratory time, using bronchodilators, and undergoing lung volume reduction surgery. Among these methods, reducing breathing rate to prolong expiratory time may be the most feasible, and investigators aim to change the rhythm and pace of breathing by adjusting the pedal rate of cycling exercise. The pedaling rate is typically set at 60 revolutions per minute. The European Respiratory Society recommended a pedal rate range of 40-70 revolutions per minute in 2019. There is still no consensus on the relationship between pedal rate and respiratory rate. This prospective observational study, using a crossover design, aims to investigate the effects of pedal rate during exercise testing on dynamic hyperinflation and exercise capacity in patients with obstructive airway disease. conditions: Obstructive Airway Disease studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED measure: Inspiratory capacity during exercise measure: Change of FEV1 and symptoms sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: National Taiwan University Hospital city: Taipei zip: 100 country: Taiwan lat: 25.04776 lon: 121.53185 hasResults: False
<\|newrecord\|> nctId: NCT06332807 id: NGGT002-P-2301 briefTitle: AAV Gene Therapy Clinical Study in Adult Classic PKU overallStatus: NOT_YET_RECRUITING date: 2024-05-22 date: 2030-12-30 date: 2030-12-30 date: 2024-03-27 date: 2024-03-27 name: NGGT (Suzhou) Biotechnology Co., Ltd. class: INDUSTRY briefSummary: This is a Phase 1/2, open-label, multiple-center, dose escalation and cohort expansion study to evaluate the safety and efficacy of NGGT002 in adult subjects with classic Phenylketonuria (PKU). NGGT002 is an rAAV8 based vector carrying a functional copy of the human PAH gene.
Participants will receive a single administration of NGGT002 and will be followed for safety and efficacy for 5 years. conditions: Phenylketonurias studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 12 type: ESTIMATED name: NGGT002 measure: Incidence and severity of Adverse Events (AEs) measure: Change from baseline in clinical laboratory values measure: Change from baseline in 12-lead electrocardiograms (ECGs), vital signsand physical examinations measure: Change from baseline in Plasma Phe Concentration measure: Incidence of sustained plasma Phe concentration of ≤360 μmol/L at Week 12, Week 28, Week 52 and during Year 1 to 5 post dose measure: Change from baseline in total protein intake at at Week 28, Week 52 and during Year 1 to 5 post dose measure: Change in PKU Profile of Mood States (POMS) measure: Change in Phenylketonuria Quality of Life Questionnaire (PKU-QOL) sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT hasResults: False
<\|newrecord\|> nctId: NCT06332794 id: H-2201 briefTitle: Keep On Keep Up for Parkinson's acronym: KOKU4PD overallStatus: NOT_YET_RECRUITING date: 2024-06-03 date: 2025-03-01 date: 2025-06-30 date: 2024-03-27 date: 2024-04-24 name: Northumbria University class: OTHER name: University of Manchester name: Northumbria Healthcare NHS Foundation Trust name: Newcastle University name: Reason Digital briefSummary: The goal of this mixed methods, user research study is to evaluate the Keep On Keep Up programme for people with Parkinson's (KOKU4PD).
The main aims of the study are to:
1. To explore the usability and acceptability of the PD specific KOKU programme from a user and health care professional perspective.
2. To produce a KOKU4PD digital program that is ready for National Health Service (NHS) approval and a future effectiveness evaluation.
Participants will use the KOKU4PD app at home for 4 weeks. They will be assessed at baseline and after the 4 weeks to measure aspects of their disease status, mobility, thinking, mood and quality of life. They will also be asked to complete some questionnaires about the usability of the app. conditions: Parkinson's Disease studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 20 type: ESTIMATED name: KOKU4PD measure: Usability of the KOKU app measure: Executive clock drawing task (CLOX 1, 2) (mean Change from baseline) measure: Trail Making Test (mean Change from baseline) measure: Freezing of Gait Questionnaire (mean Change from baseline) measure: Falls Efficacy scale (mean Change from baseline) measure: Parkinson's disease quality of life questionnaire - PDQ-39 (mean Change from baseline) measure: Mini-BESTest (mean Change from baseline) measure: Two minute walk test, single and dual task (mean Change from baseline) measure: EuroQol-5 Dimension Quality of Life tool - EQ5D-5L (mean Change from baseline) measure: Activities-specific Balance Confidence (ABC) Scale (mean Change from baseline) measure: Multidimensional Fatigue Inventory (MFI) (mean Change from baseline) measure: Technology Acceptance questionnaire sex: ALL minimumAge: 40 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Northumbria University city: Newcastle upon Tyne state: Tyne & Wear zip: NE1 8ST country: United Kingdom name: Gill Barry, PhD role: CONTACT phone: 01912277635 email: gill.barry@northumbria.ac.uk name: Julia Das role: CONTACT phone: 01912373343 email: julia.das@northumbria.ac.uk lat: 54.97328 lon: -1.61396 hasResults: False

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