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<|newrecord|> nctId: NCT06379035 id: Protozoa in CRC patients briefTitle: Blastocystis and Cryptosporidium Infection in Colorectal Cancer Patients overallStatus: NOT_YET_RECRUITING date: 2024-11-01 date: 2025-11-01 date: 2025-12-31 date: 2024-04-23 date: 2024-04-23 name: Assiut University class: OTHER briefSummary: 1. Detect the prevelance of Blastocystis spp. and Cryptosporidium spp. among patients with colorectal cancer attending South Egypt Cancer Institute-Assiut University. |
2. Detect the effect of Blastocystis and Cryptosporidium infection on various cytokines level in CRC patients that may be involved in the tumor progression. conditions: Blastocystis Infection conditions: Cryptosporidium Infection conditions: Colorectal Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 54 type: ESTIMATED name: ELISA / PCR measure: Detect the prevelance of Blastocystis spp. and Cryptosporidium spp. among patients with colorectal cancer attending South Egypt Cancer Institute-Assiut University. measure: Detect the effect of Blastocystis and Cryptosporidium infection on various cytokines level in CRC patients that may be involved in the tumor progression. sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06379022 id: AUTh-29/21-11-2018 briefTitle: Proteomic Analysis of Newly Restored Single Implants overallStatus: COMPLETED date: 2018-12-03 date: 2019-11-29 date: 2019-11-29 date: 2024-04-23 date: 2024-04-23 name: Aristotle University Of Thessaloniki class: OTHER name: Karolinska Institutet briefSummary: In 10 systemically healthy non-smokers, free of periodontitis, one newly restored implant (baseline-T0) and one corresponding tooth were followed over 12 months (T1). All implants were screw-retained, and platform-switched. Oral hygiene was closely monitored during the study. Probing pocket depth (PPD), attachment levels (CAL), bleeding and plaque indices and crevicular fluid were collected from an implant-site (PICF) and a tooth-site (GCF). Total proteomic profiles in PICF and GCF were investigated using label-free quantitative proteomics. conditions: Peri-Implantitis conditions: Peri-implant Mucositis conditions: Periodontal Diseases studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 10 type: ACTUAL name: Plaque control measure: Probing pocket depth measure: Protein expression measure: Recession measure: Bleeding upon probing measure: Inflammation index sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Dental School, Aristotle University city: Thessaloniki zip: 54124 country: Greece lat: 40.64361 lon: 22.93086 hasResults: False |
<|newrecord|> nctId: NCT06379009 id: 473076 briefTitle: Effect of Home-based Training Program for Kidney Transplant Recipients (HOMETRAIN-KTR) overallStatus: RECRUITING date: 2024-02-07 date: 2027-01-01 date: 2028-01-01 date: 2024-04-23 date: 2024-04-24 name: Oslo University Hospital class: OTHER name: South-Eastern Norway Regional Health Authority briefSummary: Does home-based training work in kidney transplant recipients with reduced physical function? |
The goal of this clinical trial is to learn if home-based training works to better physical function in adult kidney transplant recipients. It will also learn about participants preoperative physical function. The main question it aim to answer is |
* Does home-based training improves physical function in kidney transplant recipients. |
* All the participants are assessed to have reduced physical function before the transplantation |
Participants will: |
* follow either a home-based training program or todays standard of physical activity after kidney transplantation |
* the program starts 4 weeks after the transplantation and lasts for 12 weeks. A physiotherapist will help the participants in the beginning. |
* the program consists of both cardio-training, strength-straining and optional activity |
* the training group will be followed up every week by phone. Their activity will be documented via patients logs and heart rate monitor. |
* the effect of the training will be evaluated one year after the transplantation conditions: Kidney Transplant; Complications conditions: Frailty conditions: Physical Disability studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: 2 arms randomized control study. The intervention arm is exposed of a 12 week home-based training program. The control arm follow standard of care. primaryPurpose: TREATMENT masking: NONE maskingDescription: Both participants and investigators will know which arm the participants are randomized to. Training is not easy to mask count: 200 type: ESTIMATED name: Training measure: 6-minute walking distance test measure: Clinical Frailty Scale measure: Hand-grip strength measure: 30 seconds Sit-to-stand test measure: Bone density test measure: Bioelectrical impedance phase angle to measure muscle mass and strength. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Oslo University Hospital status: RECRUITING city: Oslo zip: 0372 country: Norway lat: 59.91273 lon: 10.74609 hasResults: False |
<|newrecord|> nctId: NCT06378996 id: S68535 briefTitle: Arrhythmic Mitral Valve Prolapse Detection Using Long-term Ambulatory Rhythm Monitoring acronym: ALARM-PILOT overallStatus: RECRUITING date: 2024-05 date: 2024-09 date: 2024-10 date: 2024-04-23 date: 2024-04-23 name: Universitaire Ziekenhuizen KU Leuven class: OTHER briefSummary: Mitral valve prolapse (MVP) affects up to 3% of the general population and a small subset of patients is at risk for ventricular arrhythmias. This subgroup is referred to as AMVP (arrhythmic MVP) and was recently defined using the following criteria: (1) Presence of MVP), (2) Ventricular arrhythmia that is either frequent (≥5% total premature ventricular contraction (PVC) burden on Holter) or complex (non-sustained ventricular tachycardia (nsVT), ventricular tachycardia (VT), or ventricular fibrillation (VF)), and (3) The absence of any other well-defined arrhythmic substrate. |
Currently, diagnosis is often based on repeated 24-hour Holter monitoring. However, the ventricular arrhythmia burden varies from day-to-day and long-term rhythm monitoring has shown in other pathologies to increase the diagnostic yield with up to 200% (from 22.5% on 24h to 75.3% on 14 days). |
This pilot study aims to study the diagnostic yield of long-term rhythm monitoring in patients with MVP as well as the day-to-day variability of ventricular arrhythmias to facilitate power calculation for a future large-scale prospective registry. conditions: Mitral Valve Prolapse conditions: Ventricular Arrythmia studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Prospective, single arm, interventional cohort study including 3 different patient cohorts: |
* Patients with MVP (not previously known with AMVP) and mild to moderate mitral valve regurgitation |
* Patients with AMVP and mild to moderate mitral valve regurgitation |
* Patients with MVP and severe mitral valve regurgitation scheduled for surgical intervention primaryPurpose: DIAGNOSTIC masking: NONE count: 60 type: ESTIMATED name: 14-day rhythm monitoring measure: Time to arrhythmic mitral valve prolapse detection measure: Number of days with high PVC-burden ≥5% measure: Number of days with complex ventricular arrhythmia (nsVT, VT, or VF) measure: Day-to-day variation in percentage PVC burden measure: Association between percentage PVC burden and percentage of late gadolinium enhancement on cardiac MRI measure: Association between mean number of nsVT episodes per 24hours and percentage of late gadolinium enhancement on cardiac MRI measure: Association between percentage PVC burden and global longitudinal strain on transthoracic echocardiography measure: Association between mean number of nsVT episodes per 24hours and global longitudinal strain on transthoracic echocardiography sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UZ Leuven status: RECRUITING city: Leuven state: Vlaams-Brabant zip: 3000 country: Belgium name: Bert Vandenberk, MD, PhD role: CONTACT email: [email protected] name: Bert Vandenberk, MD PhD role: PRINCIPAL_INVESTIGATOR lat: 50.87959 lon: 4.70093 hasResults: False |
<|newrecord|> nctId: NCT06378983 id: SYSKY-2023-1149-02 briefTitle: Clinical Trial of Microneedle Radiofrequency Combined With Oral Isotretinoin in Moderate to Severe Acne overallStatus: RECRUITING date: 2022-09-01 date: 2024-06-30 date: 2024-06-30 date: 2024-04-23 date: 2024-04-23 name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University class: OTHER briefSummary: This study plans to select 100 AV patients and randomly divide them into two groups in a 1:1 ratio: the experimental group will be treated with MRF combined with oral isotretinoic acid for 8 consecutive weeks, with a total of 3 MRF treatments at weeks 1, 4, and 8. The control group received oral administration of isotretinoic acid alone for 8 weeks. The main observation indicators are the percentage of effective skin injury clearance achieved by subjects at week 20, as well as the change in ECCA acne scar score compared to baseline at week 20. I hope this study can clarify that the combination therapy of the two can achieve the effects of improving efficacy, shortening treatment course, reducing recurrence, not increasing adverse reactions, and reducing the risk of scar formation. conditions: Moderate to Severe Acne Vulgaris studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 100 type: ESTIMATED name: Oral isotretinoin name: Oral isotretinoin combined with microneedle radiofrequency therapy measure: Changes in ECCA acne scar score from baseline at week 20 measure: The percentage of effective skin lesion clearance rate in the 20th week sex: ALL minimumAge: 14 Years maximumAge: 65 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Dermatology and Venereology, Sun Yat-sen Memorial Hospital, Sun Yat-sen University. status: RECRUITING city: Guangzhou zip: 510030 country: China name: Sha Lu role: CONTACT phone: 13632383399 email: [email protected] lat: 23.11667 lon: 113.25 hasResults: False |
<|newrecord|> nctId: NCT06378970 id: 22-1T/49 briefTitle: Audio Books Effects on Anxiety and Vital Sings overallStatus: COMPLETED date: 2022-04-15 date: 2022-07-15 date: 2022-07-15 date: 2024-04-23 date: 2024-04-23 name: Ege University class: OTHER briefSummary: Objectives: This study aimed to investigate the effect of audio book use on anxiety and vital signs in patients receiving non-invasive mechanical ventilation (NIMV) support. |
Research Methodology/Design: It is an experimental-randomised controlled study. Settings: The study was carried out with patients hospitalised in the Chest Diseases Intensive Care Unit of a university hospital and NIMV support. The participants consisted of 60 people, 30 in the intervention group and 30 in the control group. Before starting the application in the intervention group, the book preferences of the patients were determined and the selected audio book was played to the patients with headphones via tablet/smartphone. No additional application was made to the control group. |
Main Outcome Measures: Anxiety levels and vital signs in the intervention group were evaluated before, 15 minutes, 30 minutes and 30 minutes after the end of the intervention. In the control group, only routine care continued and anxiety levels, and vital signs were assessed simultaneously with the intervention group. conditions: Non-invasive Mechanical Ventilation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomised Controlled primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 60 type: ACTUAL name: Audio Book Application measure: Facial Anxiety Scale measure: Patient Follow-up Form measure: Audio Book Application Preference Form measure: Patient Information Form sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ege University city: Bornova state: İzmir zip: 35100 country: Turkey lat: 38.47921 lon: 27.2399 hasResults: False |
<|newrecord|> nctId: NCT06378957 id: IRB00436545 briefTitle: Behavioral Pharmacology of Orally Administered THC and D-limonene overallStatus: NOT_YET_RECRUITING date: 2024-09-01 date: 2027-07-01 date: 2027-12-31 date: 2024-04-23 date: 2024-04-23 name: Johns Hopkins University class: OTHER name: National Institutes of Health (NIH) briefSummary: The current clinical trial will investigate the effects of orally administered d-limonene (limonene), delta-9-tetrahydrocannabinol (THC) and the combination in healthy adult volunteers. conditions: Subjective Drug Effects conditions: THC conditions: D-limonene studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Within-subjects design where participants are randomly assigned to dose conditions primaryPurpose: BASIC_SCIENCE masking: DOUBLE maskingDescription: place controlled, double-blind whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 65 type: ESTIMATED name: D-Limonene name: Delta-9-THC name: Placebo measure: Subjective Drug Effect as assessed by Visual Analog Scale measure: Subjective Drug Liking as assessed by Visual Analog Scale measure: Subjective anxiety as assessed by Visual Analog Scale measure: Subjective hunger as assessed by Visual Analog Scale measure: Subjective paranoia as assessed by Visual Analog Scale sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Johns Hopkins Behavioral Pharmacology Research Unit city: Baltimore state: Maryland zip: 21224 country: United States lat: 39.29038 lon: -76.61219 hasResults: False |
<|newrecord|> nctId: NCT06378944 id: 61/23 briefTitle: Selective Sentinella Lymph Node Biopsy With Indocyanine Green in Patients With Breast Cancer acronym: INSEAN overallStatus: RECRUITING date: 2024-01-01 date: 2029-01-01 date: 2029-01-01 date: 2024-04-23 date: 2024-04-23 name: Omphis Foundation class: OTHER briefSummary: The current observational study aims to perform the sentinel lymph node in breast cancer in the usual way with technetium 99 and add a second tracer, indocyanine green. The objective is to evaluate the detection rate of the lymph node with indocyanine green compared to the usual technique. conditions: Breast Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 15000 type: ESTIMATED name: Application of green indocyanine colorant name: Technetium99 measure: Number of Sentinel lymph node detected. Scale of numbers measure: Number of possitive lymph nodes measure: surgery time in minutes sex: ALL minimumAge: 18 Years maximumAge: 120 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sandra Lopez Gordo status: RECRUITING city: Cerdanyola Del Valles state: Barcelona zip: 08290 country: Spain name: Sandra Lopez gordo role: CONTACT phone: 660284047 email: [email protected] lat: 41.49109 lon: 2.14079 hasResults: False |
<|newrecord|> nctId: NCT06378931 id: 2024HX161 briefTitle: Quality of Life Change in Patients Undergoing Parathyroidectomy With End-stage Renal Failure overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2025-12-30 date: 2025-12-30 date: 2024-04-23 date: 2024-04-23 name: Chunling Jiang class: OTHER briefSummary: The purpose of this study is to characterize the quality of life change in patients undergoing parathyroidectomy with secondary hyperparathyroidism due to end-stage renal failure. conditions: Secondary Hyperparathyroidism conditions: End Stage Renal Failure studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 80 type: ESTIMATED name: Quality of life progression after parathyroidectomy measure: Measure quality of life scores change with respect to time measure: Measure anxiety and depression score change with respect to time measure: Measure bone pain scores change with respect to time measure: Length of hospital stay sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06378918 id: 2023-A02791-44 briefTitle: Comparison of the Effectiveness of the Simple Puncture Compared to the Incision of an Abscess on the piLOnidal Sinus acronym: PILO overallStatus: NOT_YET_RECRUITING date: 2024-06-15 date: 2025-04-15 date: 2027-04-15 date: 2024-04-23 date: 2024-04-23 name: University Hospital, Angers class: OTHER_GOV briefSummary: Pilonidal disease is a common disease characterized by the presence of abscess in the intergluteal groove. During periods of abscess, current recommendations are to make a simple incision with daily wicking of the abscess. Direct excision at this time is not recommended because there is a risk of incomplete excision. The principle of directed healing after incision of the abscess results in an average dressing period of 21 days. A definitive resection is recommended after 4 to 6 weeks, when healing has been achieved, in order to limit the risk of infectious recurrence. |
An alternative has recently been proposed, consisting of a puncture of the abscess, aimed at emptying it under antibiotic coverage. The major advantage of this treatment is that patients no longer need general anesthesia to flatten the abscess. Although this technique is promising, it is currently not the subject of any published or ongoing randomized controlled study registered on Clinicaltrials.gov. |
The research hypothesis is that the two techniques have the same results in terms of recurrence before definitive surgical treatment but that drainage puncture would imply a faster healing time, a lower cost of treatment, a quality of superior support, reduced support time and reduced work stoppage. conditions: Pilonidal Cyst studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 134 type: ESTIMATED name: puncture name: incision of the abscess measure: healing time measure: Effectiveness of the 2 procedures measure: Cost-utility analysis measure: Duration of nursing care measure: Duration of work stoppage measure: Returning to work measure: Quality of life measure: Healing after definitive resection sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06378905 id: 141/57 briefTitle: Cukurova Score Validation Study acronym: CUKUROVA overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-03 date: 2027-03 date: 2024-04-23 date: 2024-04-23 name: Cukurova University class: OTHER name: Muğla Sıtkı Koçman University name: Sakarya University name: Gazi University name: Ankara Etlik City Hospital name: Kayseri City Hospital name: Mersin University name: Selçuk University name: Bezmialem Vakif University name: Uludag University name: Mersin City Hospital name: Marmara University name: Prof. Dr. Cemil Tascıoglu City Hospital name: Ankara University name: Ege University name: Hacettepe University name: Akdeniz University name: Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital name: Mustafa Kemal University name: Trakya University briefSummary: Despite significant advancements in imaging technologies, surgical techniques, chemotherapeutic regimens, and treatment strategies in recent years, ovarian cancer continues to remain the most deadly gynecological malignancy. Approximately 90% of ovarian cancers originate from the coelomic epithelium or modified mesothelial cells and are classified as epithelial ovarian cancers. The majority of patients with epithelial ovarian cancer (70-80%) present in advanced stages. The primary treatment for advanced-stage (stage 3-4) disease consists of primary cytoreductive surgery followed by adjuvant chemotherapy. Cytoreductive surgery aims to remove all visible tumor implants regardless of the extent of the disease and achieve no visible residual tumor (complete cytoreduction, R0) at the end of the surgery. In cases where R0 cannot be achieved (due to poor general condition and/or extensive tumor that cannot be completely excised surgically), the option of neoadjuvant chemotherapy followed by interval cytoreductive surgery is considered. Primary cytoreductive surgery is still the preferred option and is considered a quality indicator for centers performing advanced-stage ovarian cancer surgeries. Despite advancements in surgery, the decision for interval surgery following primary surgery or neoadjuvant chemotherapy is often based on the surgeon's experience, imaging results, and clinic preferences. Various methods and scores have been published and applied to predict which patients are suitable for primary surgery. |
The Cukurova score developed in our clinic conceptualizes prioritizing surgical procedures using radiological imaging and diagnostic exploratory laparoscopy to achieve complete cytoreduction in harmony with the patient's clinical and performance status, rather than focusing solely on tumor burden. The score showed high success rates for complete cytoreduction and also was useful in terms of predicting the morbidity and mortality. However, the Cukurova score study was conducted in single center. Validation of scores in centers with different capacities is expected to facilitate their widespread use and acceptance. Therefore, in this study, the investigators plan to conduct a validation study of the score in a total of 20 centers in Turkey, including our center. This study aims to evaluate the validity of the Cukurova score in predicting outcomes of primary cytoreduction in advanced ovarian cancer patients and thus determining the decision for primary cytoreductive surgery or neoadjuvant chemotherapy followed by interval cytoreductive surgery. conditions: Epithelial Ovarian Cancer conditions: Primary Cytoreduction studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 130 type: ESTIMATED measure: Rate of complete cytoreduction measure: Rate of postoperative 90-days mortality measure: Rate of postoperative morbidity sex: FEMALE minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Cukurova University city: Adana zip: 01330 country: Turkey name: Ghanim Khatib, MD role: CONTACT phone: 03223386060 email: [email protected] name: Ghanim Khatib, MD role: CONTACT phone: +903223386060 phoneExt: Khatib email: [email protected] name: Ghanim Khatib, MD,Ass.Prof role: PRINCIPAL_INVESTIGATOR lat: 37.00167 lon: 35.32889 hasResults: False |
<|newrecord|> nctId: NCT06378892 id: CRO-2023-78 briefTitle: A Study to Evaluate the Combination of Platinum-pemetrexed Based Chemotherapy Plus Lorlatinib in ALK Positive Non-Small Cell Lung Cancer (NSCLC) With Exclusively Extracranial Disease Progression on Lorlatinib acronym: ALK-PPL overallStatus: RECRUITING date: 2024-03-15 date: 2028-05 date: 2028-05 date: 2024-04-23 date: 2024-04-23 name: Centro di Riferimento Oncologico - Aviano class: OTHER briefSummary: This study aims to evaluate the activity and safety of the combination of platinum-pemetrexed based chemotherapy plus Lorlatinib in ALK positive Non-Small Cell Lung Cancer (NSCLC) with exclusively extracranial disease progression on Lorlatinib. Platinum-pemetrexed based chemotherapy plus Lorlatinib will be administered for an induction phase of four cycles. Subsequently, patients with response or stability of disease at radiological assessment will start the maintenance phase with pemetrexed-Lorlatinib in 21-day cycles until progression, unacceptable toxicity, death, or withdrawal of consent. conditions: Non Small Cell Lung Cancer Metastatic conditions: ALK Gene Mutation studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 45 type: ESTIMATED name: Lorlatinib measure: Compare Progression Free Survival between patients treated with Pemetrexed (PT)/pem-based chemotherapy plus Lorlatinib after Lorlatinib versus retrospective data of 3,2 months for patients treated with PT/pem-based chemotherapy after Lorlatinib. measure: Intracranial Progression Free Survival (PFS) in patients treated with PT/pem-based chemotherapy plus Lorlatinib after Lorlatinib. measure: Overall survival (OS) in patients treated with PT/pem-based chemotherapy plus Lorlatinib after Lorlatinib progression measure: Describe the safety of PT/pem-based chemotherapy plus Lorlatinib combination sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Centro di Riferimento Oncologico (CRO) IRCCS status: RECRUITING city: Aviano zip: 33081 country: Italy name: Alessandra Bearz role: CONTACT phone: 0434659294 email: [email protected] lat: 46.07056 lon: 12.59472 facility: Azienda Ospedaliero-Universitaria Careggi Oncologia Medica status: NOT_YET_RECRUITING city: Firenze zip: 50134 country: Italy name: Lorenzo Antonuzzo role: CONTACT phone: 0557947298 email: [email protected] lat: 43.77925 lon: 11.24626 facility: Azienda USL Toscana Nord Ovest Oncologia Medica, Ospedale Versilia status: NOT_YET_RECRUITING city: Lido Di Camaiore zip: 55049 country: Italy name: Camerini Andrea role: CONTACT phone: 05846057282 email: [email protected] lat: 43.90012 lon: 10.2269 facility: Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino amadori" status: NOT_YET_RECRUITING city: Meldola zip: 47014 country: Italy name: Delmonte Angelo role: CONTACT phone: 0543739100 email: [email protected] lat: 44.12775 lon: 12.0626 facility: Fondazione IRCCS San Gerardo dei Tintori status: NOT_YET_RECRUITING city: Monza zip: 20900 country: Italy name: Cortinovis Diego Luigi role: CONTACT phone: 0392336040 email: [email protected] lat: 45.58005 lon: 9.27246 facility: IOV Istituto Oncologico Veneto IRCCS status: NOT_YET_RECRUITING city: Padova zip: 35128 country: Italy name: Pasello Giulia role: CONTACT phone: 0498215608 email: [email protected] lat: 45.40797 lon: 11.88586 facility: Azienda Ospedaliero-Universitaria di Parma status: NOT_YET_RECRUITING city: Parma zip: 43126 country: Italy name: Tiseo Marcello role: CONTACT phone: 0521702316 email: [email protected] lat: 44.79935 lon: 10.32618 facility: Azienda Ospedaliera di Perugia status: NOT_YET_RECRUITING city: Perugia zip: 06129 country: Italy name: Metro Giulio role: CONTACT phone: 0755783695 email: [email protected] lat: 43.1122 lon: 12.38878 facility: Azienda Sanitaria Universitaria Friuli Centrale (ASU FC) status: NOT_YET_RECRUITING city: Udine zip: 33010 country: Italy name: Giacomo Pellizzari role: CONTACT phone: 0432552754 email: [email protected] lat: 46.0693 lon: 13.23715 hasResults: False |
<|newrecord|> nctId: NCT06378879 id: 1073/1/3/26 briefTitle: Intermittent Boluses Versus Infusion of Propofol During Gastroscopy overallStatus: NOT_YET_RECRUITING date: 2024-05-06 date: 2025-04-30 date: 2025-07-30 date: 2024-04-23 date: 2024-04-23 name: Al-Balqa Applied University class: OTHER name: Luzmila Hospital briefSummary: It is unclear whether continuous infusion or intermittent bolus injection of propofol is better for achieving adequate sedation during a standard upper endoscopy. The study aimed to compare the efficacy and safety of continuous infusion and intermittent bolus injection of Propofol (Diprivan) during a standard upper endoscopy. In this prospective study, patients will be randomly assigned to undergo a standard upper endoscopy with either continuous infusion (CI group) or intermittent bolus injection (BI group) of Propofol (Diprivan) administered by an anesthesiologist. The primary outcome will be to assess the quality of sedation by the endoscopist (VAS). In addition to other sedation-related parameters that will include sedation induction time (minutes), total dose of propofol (mg), recovery time (minutes) using Aldrete score, any involuntary patient movement, and adverse events. conditions: Anesthesia studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 100 type: ESTIMATED name: Propofol 100 MG in 10 ML Injection measure: Sedation induction time (minutes) measure: Total dose of propofol (mg) measure: Recovery time (minutes) measure: Involuntary movement measure: Quality of sedation measure: Adverse events sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06378866 id: MC230502 id: NCI-2024-02978 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: 23-012176 type: OTHER domain: Mayo Clinic Institutional Review Board id: MC230502 type: OTHER domain: Mayo Clinic in Rochester briefTitle: Stereotactic Body Radiation Therapy Plus Androgen Receptor Pathway Inhibitor and Androgen Deprivation Therapy for Treatment of Metastatic, Recurrent Hormone-Sensitive Prostate Cancer, DIVINE Trial acronym: DIVINE overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2029-04-30 date: 2029-04-30 date: 2024-04-23 date: 2024-04-23 name: Mayo Clinic class: OTHER briefSummary: This phase II trial studies the effects of stereotactic body radiation therapy (SBRT) and the timing of treatment with androgen receptor pathway inhibitor (ARPI) plus androgen deprivation therapy (ADT) in treating patients with hormone sensitive prostate cancer that has spread from where it first started to other places in the body (metastatic), and that has come back after a period of improvement (recurrent). SBRT is a type of external radiation therapy that uses special equipment to position a patient and precisely deliver radiation to tumors in the body (except the brain). The total dose of radiation is divided into smaller doses given over several days. This type of radiation therapy helps spare normal tissue. Androgen can cause the growth of prostate cells. ADT lowers the amount of androgen made by the body. This may help stop the growth of tumor cells that need androgen to grow. Androgen receptor pathway inhibitors work by blocking the effects of androgen to stop the growth and spread of tumor cells. Giving SBRT alone with watchful waiting may be as effective in treating prostate cancer as giving SBRT together with ARPI and ADT. conditions: Recurrent Castration-Sensitive Prostate Carcinoma conditions: Stage IVB Prostate Cancer AJCC v8 conditions: Recurrent Prostate Cancer conditions: Castration-resistant Prostate Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 120 type: ESTIMATED name: Abiraterone name: Apalutamide name: Biospecimen Collection name: Bone Scan name: Computed Tomography name: Darolutamide name: Degarelix name: Enzalutamide name: Goserelin name: Histrelin name: Leuprolide name: Magnetic Resonance Imaging name: Patient Observation name: Positron Emission Tomography name: Prednisone name: Questionnaire Administration name: Relugolix name: Stereotactic Body Radiation Therapy name: Triptorelin measure: Modified radiographic progression-free survival (mrPFS) measure: Overall survival (OS) measure: Biologic progression-free survival (bPFS) measure: Time to local progression (TLP) measure: Time to distant progression (TDP) measure: Adverse event (AE) rate sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mayo Clinic in Rochester city: Rochester state: Minnesota zip: 55905 country: United States name: Clinical Trials Referral Office role: CONTACT phone: 855-776-0015 email: [email protected] name: Jacob J. Orme, M.D., Ph.D. role: PRINCIPAL_INVESTIGATOR lat: 44.02163 lon: -92.4699 hasResults: False |
<|newrecord|> nctId: NCT06378853 id: 2023DZKY-049-01 briefTitle: Risk Factors of Postoperative Complications and Survival Rate in Pancreatic Ductal Adenocarcinoma Patients overallStatus: COMPLETED date: 2019-01-01 date: 2023-12-31 date: 2024-02-28 date: 2024-04-23 date: 2024-04-23 name: Jinling Hospital, China class: OTHER briefSummary: By evaluating the nutritional status of patients with pancreatic ductal adenocarcinoma (PDAC) admitted to Jinling Hospital, collecting relevant clinical data. we aim to conduct correlation analysis with patient clinical information, such as survival time, hospitalization time, nutritional status, hematological indicators, etc., in order to reveal the prognostic factors for overall survival and postoperative complications of PDAC patients. conditions: Pancreatic Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 548 type: ACTUAL name: no intervention measure: complications measure: overall survival measure: risk factors sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Jinling Hospital city: Nanjing country: China lat: 32.06167 lon: 118.77778 hasResults: False |
<|newrecord|> nctId: NCT06378840 id: KY2021-268-B briefTitle: the Predictive Value of Immune Cell in Locally Advanced Cervical Cancer overallStatus: RECRUITING date: 2022-01-01 date: 2024-12-30 date: 2024-12-30 date: 2024-04-23 date: 2024-04-23 name: RenJi Hospital class: OTHER briefSummary: To explore the predictive value of immune cells by single-cell sequencing on the outcome of locally advanced cervical cancer treated by concurrent chemoradiotherapy Followed by PD-1 inhibitor conditions: Locally Advanced Cervical Carcinoma conditions: Concurrent Chemoradiotherapy conditions: Immunotherapy studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 20 type: ESTIMATED name: Nab-paclitaxel/Platinum, Sintilimab measure: the change of immune cells in the blood after chemoradiotherapy and immunotherapy measure: the predictive value of the changed immune cell subtype in the blood on the side effect of immunotherapy measure: the predictive value of the changed immune cell subtype in the blood on the effect of chemoradiotherapy and immunotherapy measure: the change of immune cells in the tissue after chemoradiotherapy measure: the predictive value of the changed immune cell subtype in the tissue on the effect of chemoradiotherapy and immunotherapy measure: the predictive value of the changed immune cell subtype in the tumor microenvironment on the side effect of immunotherapy sex: FEMALE minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: RenJi hospital status: RECRUITING city: Shanghai zip: 200127 country: China name: Haiyan Chen, Dr role: CONTACT phone: +862168383624 email: [email protected] lat: 31.22222 lon: 121.45806 hasResults: False |
<|newrecord|> nctId: NCT06378827 id: 418-1/2 briefTitle: Intraoperative Dexmedetomidine and Coronary Artery Bypass Graft Surgery overallStatus: RECRUITING date: 2024-04-03 date: 2024-07 date: 2024-10 date: 2024-04-23 date: 2024-04-23 name: University of Novi Sad class: OTHER briefSummary: This is a prospective randomized clinical trial designed to determine the effect of intraoperative dexmedetomidine administration on renal function after coronary artery bypass graft surgery. conditions: Acute Kidney Injury studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 100 type: ESTIMATED name: Dexmedetomidine measure: Indicator of renal function measure: An early biomarker of kidney injury measure: The change of inflammatory markers measure: Length of postoperative mechanical ventilation measure: Length of stay in the intensive care unit sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Novi Sad, Faculty of Medicine status: RECRUITING city: Novi Sad zip: 21000 country: Serbia name: Ranko Zdravkovic role: CONTACT phone: +381654674620 email: [email protected] lat: 45.25167 lon: 19.83694 hasResults: False |
<|newrecord|> nctId: NCT06378814 id: IRAS N335444 briefTitle: Outcome of Selective & Nonselective Caries Removal in Permanent Teeth acronym: RCT-SNCR overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-04-30 date: 2030-04-30 date: 2024-04-23 date: 2024-04-29 name: King's College London class: OTHER name: Guy's and St Thomas' NHS Foundation Trust briefSummary: Patients presenting with deep decay within permanent teeth presents a common clinical challenge to dentists. The aim of this trial is to compare the success rate of the non-selective caries removal (NSCR) and selective caries removal (SCR) in managing deep caries, as both methods are commonly used in clinical practice. |
This study will be a randomized controlled trial, with participants divided into two groups: NSCR group and SCR group. Participants of deep caries lesions (reaching more than two-thirds of dentin on periapical radiographs) Both groups will undergo either NSCR or SCR, followed by Partial Pulpotomy (PP) in cases with pulp exposure. Success rates will be assessed at follow-up visits scheduled 1, 3, and 5 years radiographs will be used to assess for pulp health(vitality). |
The success rate of the two categories will be assessed using a scale that includes factors such as tooth vitality, caries recurrence, and clinical signs of pulpitis. The scale will be applied at follow-up visits. The trial will be conducted in post-graduate dental clinics at Guy's hospital. |
Deep caries in permanent teeth is a common clinical problem that can lead to pulp exposure and subsequent restorative challenges. The aim of this study is to provide evidence-based guidance for clinicians in managing deep caries lesions, as both NSCR and SCR are commonly used in clinical practice. The results of this study will help clinicians to make informed decisions when choosing the appropriate treatment approach for their patients. |
In conclusion, this trial aims to compare the success rate of NSCR and SCR in managing deep caries lesions in permanent teeth, as both methods are commonly used in clinical practice. The results of this study will provide valuable insights into the effectiveness of these two treatment approaches and will help clinicians to make informed decisions when choosing the appropriate treatment approaches. conditions: Deep Caries conditions: Carious Exposure of Pulp studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: two arms parallel randomized clinical trial primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 168 type: ESTIMATED name: Selective Caries Removal (No Pulp Exposure) name: Non-Selective Caries Removal (No Pulp exposure) name: Partial Pulpotomy (Pulp Exposed) measure: To compare the success rate of maintaining pulp vitality assessed by pulp sensibility test between Selective Caries Removal or Non- Selective Caries Removal techniques after one year of the intervention. measure: Periapical Health Assessment Using Periapical Index Score in Deep Caries Lesion Treatment measure: Quality of Life Assessment ( Using OHIP-14 questionnaire) in Deep Caries Lesion Treatment: A Comparative Study of Selective Caries Removal and Partial Pulpotomy sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06378801 id: RADX-P-2408 briefTitle: Radicle Relaxation 24: A Study of Health and Wellness Products on Stress and Related Health Outcomes overallStatus: ACTIVE_NOT_RECRUITING date: 2024-02-29 date: 2024-05 date: 2024-08 date: 2024-04-22 date: 2024-04-24 name: Radicle Science class: INDUSTRY briefSummary: A randomized, double-blind, placebo-controlled study assessing the impact of health and wellness products on stress and related health outcomes conditions: Stress studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants will be stratified based on gender at birth, then randomized to one of the study arms primaryPurpose: OTHER masking: DOUBLE maskingDescription: The investigator is blinded to the participants' study product assignment. Participants are blinded to the study product they are assigned. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 500 type: ACTUAL name: Placebo Control Form 1 name: Relaxation Active Study Product 1.1 measure: Change in stress measure: Change in feelings of anxiety measure: Change in cognitive function measure: Change in mood (emotional distress-depression) measure: Minimal clinically important difference (MCID) in stress measure: Minimal clinically important difference (MCID) in feelings of anxiety measure: Minimal clinically important difference (MCID) in cognitive function measure: Minimal clinically important difference (MCID) in mood (emotional distress-depression) measure: Change in concentration of at-home (direct-to-consumer) specimen assays either saliva, blood or stool sex: ALL minimumAge: 21 Years maximumAge: 105 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Radicle Science, Inc city: Del Mar state: California zip: 92014 country: United States lat: 32.95949 lon: -117.26531 hasResults: False |
<|newrecord|> nctId: NCT06378788 id: 2023/211 briefTitle: Muscle Architecture and Muscle Strength in Fibromyalgia overallStatus: RECRUITING date: 2024-02-01 date: 2024-04-30 date: 2024-06-30 date: 2024-04-22 date: 2024-04-25 name: Bezmialem Vakif University class: OTHER briefSummary: The goal of this observational study is to determine whether there is decrease in muscle mass and muscle strength in Fibromyalgia Syndrome (FMS) patients in comparison to controls. And to determine whether these parameters are correlated with clinical ones. Briefly the main questions investigators aims to answer are: |
* Is there a significant difference in muscle morphology between FMS and controls? |
* Is there a significant difference in muscle strength between FMS and controls? |
* Is there a relationship between muscle thickness and pennation angle of the Quadriceps, gastrocnemius medialis, gastrocnemius lateralis and Tibialis anterior muscles and disease activity, pain and functionality? |
* Is there a correlation between muscle strength in FMS and disease activity, pain and functionality? conditions: Fibromyalgia conditions: Sarcopenia conditions: Muscle Weakness studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 30 type: ESTIMATED name: Demographic information form name: widespread pain index (WPI) name: symptom severity scale (SSS) name: Fibromyalgia Impact Questionnaire (FIQ) name: Tender Point examination name: Muscle Architecture visualized with ultrasound name: Sarcopenia assessed by measuring isometric strengths of different parts of the body name: Timed Up & Go (TUG) measure: Quadriceps Femoris Vastus Lateralis Muscle Thickness measure: Quadriceps Femoris Vastus Lateralis Fascicle Length measure: Quadriceps Femoris Vastus Medialis Muscle Thickness measure: Quadriceps Femoris Vastus Medialis Fascicle Length measure: Quadriceps Femoris Rectus Femoris Muscle Thickness measure: Quadriceps Femoris Rectus Femoris Fascicle Length measure: Tibialis Anterior Muscle Thickness measure: Tibialis Anterior Muscle Fascicle Length measure: Gastrocnemius Muscle Vastus Medialis Muscle Thickness measure: Gastrocnemius Muscle Vastus Medialis Fascicle Length measure: Gastrocnemius Muscle Vastus Lateralis Muscle Thickness measure: Gastrocnemius Muscle Vastus Lateralis Fascicle Length measure: Cervical Muscle strength measure: Truncal Muscle strength measure: Shoulder Muscle strength measure: Hip Muscle strength measure: Knee Muscle strength measure: Ankle Muscle strength measure: Timed Up & Go (TUG) sex: FEMALE minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Bezmialem Vakif University status: RECRUITING city: Istanbul state: Fatih zip: 34093 country: Turkey name: Mehmet Serkan Kılıçoğlu, Ass.Prof. role: CONTACT phone: +902124530453 email: [email protected] name: Delal Ozturk, Res.Ass. role: CONTACT phone: +902124530453 email: [email protected] lat: 41.01384 lon: 28.94966 hasResults: False |
<|newrecord|> nctId: NCT06378775 id: H23-03334 briefTitle: Robotically-assisted Minimally-invasive Direct Coronary Artery Bypass With Stenting, Randomized Against Coronary Artery Bypass Graft Surgery acronym: ROBOT RCT overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2027-05-01 date: 2028-12-01 date: 2024-04-22 date: 2024-04-23 name: Cardiology Research UBC class: OTHER briefSummary: The study objective is to compare standard CABG to a hybrid revascularization strategy (RA-MIDCAB + PCI) in patients who have multi-vessel CAD and an indication for surgery, but who have a slightly higher risk of post-operative complications. conditions: Coronary Artery Disease conditions: Multivessel Coronary Artery Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 80 type: ESTIMATED name: Coronary Artery Bypass Graft name: Robotically-assisted minimally-invasive direct coronary artery bypass name: Percutaneous Coronary Intervention measure: Post-operative Length of Stay measure: Conversion to sternotomy / CABG measure: Intubation duration measure: ICU length of stay sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06378762 id: 6/2021 briefTitle: Interference of Endurance Training on Strength Development and Neuromuscular Adaptations overallStatus: ACTIVE_NOT_RECRUITING date: 2022-04-01 date: 2024-07-30 date: 2025-07-30 date: 2024-04-22 date: 2024-04-22 name: University of Lisbon class: OTHER name: Fundação para a Ciência e a Tecnologia briefSummary: This study aims to find out if performing combined strength and endurance exercise in the same program (called concurrent training-CT) leads to similar long-term improvements in neuromuscular function as doing each type of exercise separately. The main questions it seeks to answer are: |
Does performing CT result in similar improvements in strength and power as doing just strength training? Does performing CT result in similar improvements in cardiorespiratory fitness as doing just endurance training? Are neuromuscular adaptations similar between CT and just strength training? Researchers will compare the results between three groups: the CT group, the endurance training group (E), and the strength training group (S) to answer these questions. conditions: Exercise studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 30 type: ACTUAL name: Endurance Exercise name: Strength Exercise name: Concurrent Exercise measure: Maximal Isometric Strength measure: Maximal Dynamic Strength measure: Surface EMG measure: H-reflex excitability measure: V-wave measure: Lower Body Muscle Power measure: Muscle architecture of the quadriceps femoris sex: MALE minimumAge: 18 Years maximumAge: 30 Years stdAges: ADULT facility: Faculdade de Motricidade Humana - Universidade de Lisboa city: Lisboa state: Cruz Quebrada - Dafundo zip: 1499-002 country: Portugal lat: 38.71667 lon: -9.13333 hasResults: False |
<|newrecord|> nctId: NCT06378749 id: 1R43CA275673 type: NIH link: https://reporter.nih.gov/quickSearch/1R43CA275673 briefTitle: Previvors Recharge: A Resilience Program for Cancer Previvors acronym: PreCharge overallStatus: RECRUITING date: 2024-04-11 date: 2024-07-31 date: 2024-07-31 date: 2024-04-22 date: 2024-04-24 name: Pro-Change Behavior Systems class: OTHER briefSummary: It is estimated that 1 in 279 people may be carriers of a Hereditary Cancer Syndromes (HCS), a cancer risk that is associated with germline mutations (inherited genetic mutations passed directly from a parent to a child that create a genetic predisposition to certain types of cancer). Individuals with an HCS who have never been diagnosed with cancer (Previvors) have up to an 80% lifetime risk of developing cancer and are at an increased risk of developing multiple primary cancers during their lifetime, often with onset at an early age. Previvors face multiple forms of adversity, including a multitude of annual cancer screenings and the uncertainty of not only their own health but the health of affected family members. This study will examine the acceptability and preliminary effects of PreCharge, a resilience-boosting solution specifically designed for Previvors and delivered primarily via bi-directional text messaging. PreCharge uses proven approaches to behavior change tailoring to increase resilience by promoting a positive mindset, strong social connections, and a deep sense of meaning and purpose while also proactively addressing scanxiety. Up to 150 Hereditary Cancer Previvors will be recruited for a 30-day pilot test. Participants will complete a baseline assessment, and then be provided with 30 days of access to the PreCharge program. At the end of the 30 days, they will be prompted to complete a follow-up assessment. Outcomes include 1) acceptability of the program, as evidenced by obtaining 75% endorsement that users would recommend the program to a fellow Previvor; (2) engagement as evidenced by continued receipt of text messages and one or more interactions with the online tools by at least 70% of participants; and (3) benefit from the program, evidenced by statistically significant pre-post improvement on the Connor Davidson Resilience Scale. conditions: Hereditary Cancer conditions: Mental Health Issue studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 150 type: ESTIMATED name: PreCharge measure: Connor Davidson Resilience Scale (CDRISC) measure: Cantril/Gallup Life Evaluation Index measure: Acceptance and Action Questionnaire (AAQII) measure: Patient Health Questionnaire-2 (PHQ-2) measure: Generalized Anxiety Disorder-2 (GAD-2) measure: Cancer Behavior Inventory (CBI-B V2.0-12) measure: Net Promoter Score (NPS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Pro-Change Behavior Systems status: RECRUITING city: Narragansett state: Rhode Island zip: 02882 country: United States name: Kerry E Evers, PhD role: CONTACT phone: 401-360-2985 email: [email protected] name: Madison Gilmore role: CONTACT phone: 401-360-2988 email: [email protected] name: Kerry E Evers, PhD role: PRINCIPAL_INVESTIGATOR lat: 41.4501 lon: -71.4495 hasResults: False |
<|newrecord|> nctId: NCT06378736 id: 21-1027 briefTitle: Electroencephalogram Recording in Patients With Systemic Lupus Erythematosus overallStatus: RECRUITING date: 2024-01-22 date: 2026-03-23 date: 2026-03-23 date: 2024-04-22 date: 2024-04-29 name: Northwell Health class: OTHER briefSummary: Patients with systemic lupus erythematosus (SLE) often experience a frustrating decline of their cognitive skills that includes considerable problems in attention, learning, and memory. This lupus-related cognitive dysfunction (termed SLE-CD) is recognized as the most prevalent of the nineteen neuropsychiatric SLE syndromes, as it affects up to 80% of patients and can significantly decrease their quality of life. The goal is to have tools that can be used for diagnosis and for monitoring responses after targeted interventions and therapies. This study will focus on electroencephalographic (EEG) signals, which will be detected noninvasively from scalp placed surface electrodes while the subjects are in a state of wakeful rest. Our hypothesis is that a subset of brain oscillations known as theta and gamma, and their co-modulation or coupling will be disrupted in SLE patients. This research protocol will subject patients with systemic lupus erythematosus (SLE) to scalp electroencephalography (EEG), with the goal of determining whether specific EEG patterns ('theta-gamma coupling') appear abnormal during wakeful-rest periods of 20 minutes. The investigators are interested in using scalp EEG because it is a standard, safe and robust technique for monitoring the electrophysiological activity of neurons in the cerebral cortex. conditions: Systemic Lupus Erythematosus studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 40 type: ESTIMATED name: Electroencephalography (EEG) signals, which will be detected noninvasively from dry scalp surface electrodes while the subjects are in a state of wakeful rest. measure: A measure of the amount and relationship of theta and gamma waves in the EEG recording. The ability to perform the block building task and the ability to choose among unfolded three-dimensional objects. sex: FEMALE minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Northwell Health-Feinstein Insitute status: RECRUITING city: Manhasset state: New York zip: 11030 country: United States name: Bruce T Volpe, MD role: CONTACT phone: 516-562-3384 email: [email protected] name: Celina B. Fernandez, MS role: CONTACT phone: 5165623646 email: [email protected] lat: 40.79788 lon: -73.69957 hasResults: False |
<|newrecord|> nctId: NCT06378723 id: 2024/01/24 briefTitle: The Relationship Between Upper Extremity Functionality, Trunk Control and Balance in Children With Cerebral Palsy overallStatus: ACTIVE_NOT_RECRUITING date: 2024-02-01 date: 2024-04-15 date: 2024-04-16 date: 2024-04-22 date: 2024-04-23 name: Eastern Mediterranean University class: OTHER briefSummary: The aim of this study is to examine the relationship between trunk control, upper extremity functionality and balance in children with cerebral palsy and to compare this relationship with healthy sedentary children.This study is carried out through Eastern Mediterranean University Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Pediatric Rehabilitation Unit. conditions: Cerebral Palsy conditions: Diplegic Cerebral Palsy conditions: Balance; Distorted studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: OTHER count: 53 type: ACTUAL name: Balance Tests measure: trunk control measure: upper extremity functionality measure: balance measure: Weight and Height sex: ALL minimumAge: 8 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Eastern Mediterranean University city: Famagusta zip: 99628 country: Cyprus lat: 35.12054 lon: 33.93894 facility: Yeni Sihirli Eller Özel Eğitim ve Rehabilitasyon Merkezi city: Adana state: Çukurova zip: 01170 country: Turkey lat: 37.00167 lon: 35.32889 hasResults: False |
<|newrecord|> nctId: NCT06378710 id: 22-0219 briefTitle: Haemodynamic and Respiratory Effects of a Low Positive End Expiratory Pressure Associated With a Fluid Challenge in Knee-chest Position acronym: OPTIPEP overallStatus: RECRUITING date: 2023-01-20 date: 2025-01-20 date: 2025-01-30 date: 2024-04-22 date: 2024-04-22 name: University Hospital, Caen class: OTHER briefSummary: The genu pectoral position is a surgical position used for spine surgery. This surgical position will lead to physiological hemodynamic and respiratory changes during the procedure. |
The knee-pectoral position notably induces an increase in CRF and improves pulmonary ventilation/perfusion ratios. On the other hand, it has been shown that it is accompanied by a reduction in cardiac output of approximately 15% Protective perioperative ventilation including a tidal volume between 6 and 8 ml/kg of theoretical ideal weight, PEEP and alveolar recruitment maneuvers is applied in the operating room to reduce postoperative pulmonary complications. The application of high PEEP and the performance of recruitment maneuvers induce arterial hypotension through changes in intra- and transpulmonary pressures. However, investigators hypothesize that the deleterious hemodynamic effects of PEEP seem to counterbalance its beneficial respiratory effects in this particular position. |
The combination of the effects of the knee-pectoral position and protective ventilation could be potentiated and be the cause of the sometimes severe arterial hypotension observed in clinical practice. Since this position improves pulmonary ventilation perfusion ratios, the investigators hypothesized that a lower PEEP and the elimination of intraoperative recruitment maneuvers could be beneficial from a hemodynamic point of view without being deleterious in terms of perioperative pulmonary complications. An exploratory study was carried out at the CAEN University Hospital in 2021 under the name PEEP POSTURE (CLERS Agreement No. 2198 of February 17, 2021) on 90 patients aiming to collect hemodynamic and respiratory parameters in 3 surgical positions: supine decubitus, ventral decubitus , pectoral genu. No difference was found in the evolution of respiratory compliance. On the other hand, a significant drop in SBP, DBP and MAP in the pectoral position was shown compared to the supine group as well as greater vascular filling. |
The investigators therefore hypothesize that a reduction in PEEP and optimization of vascular filling could help reduce the adverse effects on blood pressure linked to the surgical position. conditions: Surgery studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 84 type: ESTIMATED name: Optimized PEEP measure: Number of occurrences of a MAP sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CAEN University Hospital status: RECRUITING city: Caen country: France name: Mariam BOUTROS, MD role: CONTACT phone: 02.31.06.31.06 email: [email protected] lat: 49.18585 lon: -0.35912 hasResults: False |
<|newrecord|> nctId: NCT06378697 id: AK111-303 briefTitle: A Phase III Study to Evaluate the Efficacy and Safety of AK111 in Subjects With Active Ankylosing Spondylitis overallStatus: RECRUITING date: 2023-11-10 date: 2025-02-28 date: 2026-04-30 date: 2024-04-22 date: 2024-04-22 name: Akeso class: INDUSTRY briefSummary: This is a randomized, double-blind, placebo-controlled, multi-center phase III clinical study to evaluate the efficacy and safety of AK111 in the treatment of subjects with active ankylosing spondylitis. conditions: Ankylosing Spondylitis studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 510 type: ESTIMATED name: AK111 name: Placebo+AK111 measure: the response rate of ASAS20 measure: The response rate of ASAS40 measure: The response rate of ASAS20 measure: The response rate of ASAS40 measure: The response rate of ASAS5/6 measure: Change from baseline on the ASDAS-CRP measure: Change from baseline on the SF-36 PCS measure: Change from baseline on the ASQoL scores measure: Treatment-emergent adverse events measure: Serious adverse events measure: Clinically significant examination results sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: 1006-The First Affiliated Hospital of Bengbu Medical University status: RECRUITING city: Bengbu state: Anhui country: China lat: 32.94083 lon: 117.36083 facility: 1038-Anhui Provincial Hospital status: RECRUITING city: Hefei state: Anhui country: China lat: 31.86389 lon: 117.28083 facility: 1001-Peking University Third Hospital status: RECRUITING city: Beijing state: Beijing country: China lat: 39.9075 lon: 116.39723 facility: 1002-Xuanwu Hospital Capital Medical University status: RECRUITING city: Beijing state: Beijing country: China lat: 39.9075 lon: 116.39723 facility: 1042-Peking University Shougang Hospital status: RECRUITING city: Beijing state: Beijing country: China lat: 39.9075 lon: 116.39723 facility: 1049-The First Affiliated Hospital of Xiamen University status: RECRUITING city: Xiamen state: Fujian country: China lat: 24.47979 lon: 118.08187 facility: 1027-Lanzhou University Second Hospital status: RECRUITING city: Lanzhou state: Gansu country: China lat: 36.05701 lon: 103.83987 facility: 1005-Nanfang Hospital status: RECRUITING city: Guangzhou state: Guangdong country: China lat: 23.11667 lon: 113.25 facility: 1025-Guangzhou First People's Hospital status: RECRUITING city: Guangzhou state: Guangdong country: China lat: 23.11667 lon: 113.25 facility: 1030-Jieyang People's Hospital status: RECRUITING city: Jieyang state: Guangdong country: China lat: 23.5418 lon: 116.36581 facility: 1008-The Seventh Affiliated Hospital, Sun Yat-sen University status: RECRUITING city: Shenzhen state: Guangdong country: China lat: 22.54554 lon: 114.0683 facility: 1026-Shenzhen People's Hospital status: RECRUITING city: Shenzhen state: Guangdong country: China lat: 22.54554 lon: 114.0683 facility: 1056-Zhongshan Traditional Chinese Medicine Hospital status: RECRUITING city: Zhongshan state: Guangdong country: China lat: 21.31992 lon: 110.5723 facility: 1024-Liuzhou People's Hospital status: RECRUITING city: Liuzhou state: Guangxi country: China facility: 1021-The People's Hospital of Guangxi Zhuang Autonomous Region status: RECRUITING city: Nanning state: Guangxi country: China lat: 22.81667 lon: 108.31667 facility: 1022-The First Affiliated Hospital of Hainan Medical University status: RECRUITING city: Haikou state: Hainan country: China lat: 20.04583 lon: 110.34167 facility: 1034-Affiliated Hospital of Hebei University status: RECRUITING city: Baoding state: Hebei country: China lat: 38.85111 lon: 115.49028 facility: 1012-Hebei Petro China Central Hospital status: RECRUITING city: Langfang state: Hebei country: China lat: 39.50972 lon: 116.69472 facility: 1029-Hebei General Hospital status: RECRUITING city: Shijiazhuang state: Hebei country: China lat: 38.04139 lon: 114.47861 facility: 1033-The First Hospital of Qiqihar status: RECRUITING city: Qiqihar state: Heilongjiang country: China lat: 47.34088 lon: 123.96045 facility: 1045-The First Affiliated Hospital of Henan University of Science and Technology status: RECRUITING city: Luoyang state: Henan country: China lat: 34.68361 lon: 112.45361 facility: 1053-Nanyang Central Hospital status: RECRUITING city: Nanyang state: Henan country: China lat: 32.99472 lon: 112.53278 facility: 1051-Shiyan People's Hospital status: RECRUITING city: Shiyan state: Hubei country: China lat: 32.6475 lon: 110.77806 facility: 1031-The First Affiliated Hospital of University of South China status: RECRUITING city: Hengyang state: Hunan country: China lat: 26.88946 lon: 112.61888 facility: 1032-Yueyang Central Hospital status: RECRUITING city: Yueyang state: Hunan country: China lat: 29.37455 lon: 113.09481 facility: 1011-Zhuzhou Central Hospital status: RECRUITING city: Zhuzhou state: Hunan country: China lat: 27.83333 lon: 113.15 facility: 1017-Changzhou NO.2 People's Hospital status: RECRUITING city: Changzhou state: Jiangsu country: China lat: 31.77359 lon: 119.95401 facility: 1037-The Second People's Hospital of Lianyungang status: RECRUITING city: Lianyungang state: Jiangsu country: China lat: 34.59845 lon: 119.21556 facility: 1004-Zhongda Hospital Southeast University status: RECRUITING city: Nanjing state: Jiangsu country: China lat: 32.06167 lon: 118.77778 facility: 1007-Nanjing Drum Tower Hospital status: RECRUITING city: Nanjing state: Jiangsu country: China lat: 32.06167 lon: 118.77778 facility: 1036-Jiangsu Province Hospital status: RECRUITING city: Nanjing state: Jiangsu country: China lat: 32.06167 lon: 118.77778 facility: 1018-Affiliated Hospital of Nantong University status: RECRUITING city: Nantong state: Jiangsu country: China lat: 32.03028 lon: 120.87472 facility: 1035-Wuxi People's Hospital status: RECRUITING city: Wuxi state: Jiangsu country: China lat: 31.56887 lon: 120.28857 facility: 1013-Xuzhou Central Hospital status: RECRUITING city: Xuzhou state: Jiangsu country: China lat: 34.18045 lon: 117.15707 facility: 1014-Affiliated Hospital of Jiangsu University status: RECRUITING city: Zhenjiang state: Jiangsu country: China lat: 32.21086 lon: 119.45508 facility: 1047-The First Affiliated Hospital of Gannan Medical College status: RECRUITING city: Ganzhou state: Jiangxi country: China facility: 1020-The Second Affiliated Hospital of Nanchang University status: RECRUITING city: Nanchang state: Jiangxi country: China lat: 28.68396 lon: 115.85306 facility: 1039-The First Affiliated Hospital of Nanchang University status: RECRUITING city: Nanchang state: Jiangxi country: China lat: 28.68396 lon: 115.85306 facility: 1046-Pingxiang People's Hospital status: RECRUITING city: Pingxiang state: Jiangxi country: China lat: 27.61672 lon: 113.85353 facility: 1044-Jilin Provincial People's Hospital status: RECRUITING city: Changchun state: Jilin country: China lat: 43.88 lon: 125.32278 facility: 1028- Jining First People's Hospital status: RECRUITING city: Jining state: Shandong country: China lat: 35.405 lon: 116.58139 facility: 1019-Linyi City People Hospital status: RECRUITING city: Linyi state: Shandong country: China lat: 35.06306 lon: 118.34278 facility: 1055-Weifang People's Hospital status: RECRUITING city: Weifang state: Shandong country: China lat: 36.71 lon: 119.10194 facility: 1016-Zaozhuang Municipal Hospital status: RECRUITING city: Zaozhuang state: Shandong country: China lat: 34.86472 lon: 117.55417 facility: 1054-Linfen Central Hospital status: RECRUITING city: Linfen state: Shanxi country: China lat: 36.08889 lon: 111.51889 facility: 1009-Second Hospital of Shanxi Medical University status: RECRUITING city: Taiyuan state: Shanxi country: China lat: 37.86944 lon: 112.56028 facility: 1043-Yuncheng Central Hospital status: RECRUITING city: Yuncheng state: Shanxi country: China lat: 35.02306 lon: 110.99278 facility: 1010-West China Hospital,Sichuan University status: RECRUITING city: Chengdu state: Sichuan country: China lat: 30.66667 lon: 104.06667 facility: 1048-Mianyang Central Hospital status: RECRUITING city: Mianyang state: Sichuan country: China lat: 31.46784 lon: 104.68168 facility: 1041-Affiliated Hospital of North Sichuan Medical College status: RECRUITING city: Nanchong state: Sichuan country: China lat: 30.79508 lon: 106.08473 facility: 1023-The People's Hospital of Xinjiang Uyghur Autonomous Region status: RECRUITING city: Urumqi state: Xinjiang country: China lat: 43.80096 lon: 87.60046 facility: 1040- Huzhou Third People's Hospital status: RECRUITING city: Huzhou state: Zhejiang country: China lat: 30.8703 lon: 120.0933 facility: 1015-Taizhou Hospital of Zhejiang Province status: RECRUITING city: Taizhou state: Zhejiang country: China lat: 32.49069 lon: 119.90812 facility: 1050-The First Affiliated Hospital of Wenzhou Medical University status: RECRUITING city: Wenzhou state: Zhejiang country: China lat: 27.99942 lon: 120.66682 hasResults: False |
<|newrecord|> nctId: NCT06378684 id: JW22105 briefTitle: To Evaluate the Safety and Pharmacokinetic Interactions in Healthy Volunteers overallStatus: COMPLETED date: 2023-09-10 date: 2023-12-23 date: 2024-01-13 date: 2024-04-22 date: 2024-04-22 name: JW Pharmaceutical class: INDUSTRY briefSummary: The objective is to evaluate the safety and Pharmacokinetic Interactions after adminitration drug(Treatment A or B or A+B) in Healthy Volunteers conditions: Healthy studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: OTHER masking: NONE count: 48 type: ACTUAL name: Group 1: JW0104(Period 1), C2207(Period 2), JW0104 + C2207(Period 3) name: Group 2: JW0104 + C2207(Period 1), JW0104(Period 2), C2207(Period 3) name: Group 3: C2207(Period 1), JW0104 + C2207(Period 2), JW0104(Period 3) name: Group 4: JW0104(Period 1), JW0104 + C2207(Period 2), C2207(Period 3) name: Group 5: JW0104 + C2207(Period 1), C2207(Period 2), JW0104(Period 3) name: Group 6: C2207(Period 1), JW0104(Period 2), JW0104 + C2207(Period 3) measure: Cmax,ss measure: AUCτ,ss sex: ALL minimumAge: 19 Years maximumAge: 55 Years stdAges: ADULT facility: Clinical Trial Center, Severance Hospital city: Seoul country: Korea, Republic of lat: 37.566 lon: 126.9784 hasResults: False |
<|newrecord|> nctId: NCT06378671 id: ColdCough briefTitle: Single-center Clinical Study on the Safety and Effect of Bronchoscopic Cryotherapy in Patients With Chronic Cough acronym: ColdCough overallStatus: RECRUITING date: 2024-04 date: 2024-07 date: 2024-09 date: 2024-04-22 date: 2024-04-25 name: Guangzhou Medical University class: OTHER name: Ningbo SensCure Biotechnology Co., Ltd. briefSummary: Chronic cough is one of the most common complaints in respiratory specialty clinics, imposing significant economic burden on patients and severely affecting their quality of life. Currently, the pathogenesis of chronic refractory cough remains incompletely understood, and treatment remains a major challenge in clinical practice. Cryotherapy treatment via bronchoscopy has shown efficacy in certain airway diseases, but there is currently no research reporting its effects on chronic refractory cough. |
The goal of this clinical trial is to learn if Cryotherapy treatment works to treat individuals with chronic cough. It will also learn about The safety and effectiveness of the cryotherapy treatment system produced by Ningbo SensCure Biotechnology Co., Ltd.. The main questions it aims to answer are: |
* Does cryotherapy treatment lower the frequency and severity of cough and enhance quality of life? |
* Will there be safety or operational performance issues when using this cryotherapy treatment system? Researchers will compare cryotherapy treatment with no treatment to determine if cryotherapy treatment is effective for treating chronic cough. |
Participants will: |
* Take routine bronchoscopy examination, lavage, and mucosal biopsy ,with/without cryotherapy treatment locally (around the left and right main bronchi, upper trachea, and carina) |
* undergo a screening period of approximately 28 days. Follow-up visits and necessary examinations will be scheduled for the 3rd day after treatment initiation and at weeks 1, 2, 4, 8, and 12 thereafter. |
* Monitor vital signs and clinical manifestations. conditions: Chronic Cough studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: a prospective, single-center, double-blind ,randomized controlled clinical trial primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 20 type: ESTIMATED name: General treatment name: Cryotherapy Treatment measure: Device/Surgery-Related Serious Adverse Events measure: Device/Surgery Adverse Event Rate measure: Serious Adverse Event Rate measure: Device Defect Rate measure: Cough Visual Analogue Scale (VAS) measure: Cough frequency within 2 hours measure: Modified Cough Evaluation Tool (CET) measure: Leicester Cough Questionnaire (LCQ) measure: Tracheal Vibratory Cough Stimulation Test measure: Capsaicin Cough Stimulation Test measure: Performance evaluation of Cryotherapy Ablation Equipment measure: Performance evaluation of Cryotherapy Ablation Catheter sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The First Affiliated Hospital of Guangzhou Medical University status: RECRUITING city: Guangzhou state: Guangdong zip: 510163 country: China name: Shiyue Li role: CONTACT phone: +86 13902233925 email: [email protected] lat: 23.11667 lon: 113.25 hasResults: False |
<|newrecord|> nctId: NCT06378658 id: 22253 briefTitle: A Study to Learn About How Food and Esomeprazole Affect the Level of BAY2927088 in the Blood When Taken Together in Healthy Participants overallStatus: RECRUITING date: 2024-03-29 date: 2024-05-20 date: 2024-05-20 date: 2024-04-22 date: 2024-04-22 name: Bayer class: INDUSTRY briefSummary: Researchers are looking for a better way to treat people who have advanced non-small cell lung cancer (NSCLC) with specific genetic changes called epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor 2 (HER2) mutations. |
Advanced NSCLC refers to a type of lung cancer that has spread from the lungs to nearby tissues or other body parts. People with advanced NSCLC may have changes in certain proteins, like EGFR and HER2, that cause uncontrolled cell growth and increased spread of cancer. |
In this study, participants will be healthy and will not benefit from taking the study treatment, BAY2927088. However, the study will provide information about how to test BAY2927088 in future studies with people who have advanced NSCLC with EGFR or HER2 mutations. |
BAY2927088 is under development for the treatment of advanced NSCLC with EGFR or HER2 mutations. It is expected to work against these changed proteins, which might slow down the spread of cancer. |
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