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<|newrecord|> nctId: NCT06362122 id: PREDICTO-POLYP briefTitle: Anatomo-clinico-biological Profiles in Severe Nasal Polyps overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-04-01 date: 2026-10-01 date: 2024-04-12 date: 2024-04-12 name: Poitiers University Hospital class: OTHER briefSummary: Nasal sinus polyposis is a chronic inflammatory pathology of the nasal cavity and sinus cavities that causes bilateral and multifocal polyp development and has a prevalence of 2 to 4% in the general population.
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Therapeutic management consists of first-line medical treatment for anti-inflammatory purposes. Local corticosteroid therapy, using nasal sprays, is the background treatment. Surgical management is offered to patients in case of failure of medical treatment. Although effective, surgery does not protect patients from recurrence of symptoms related to regrowth of polyps. Recently, biologics have appeared, which despite its effectiveness, about 20% of patients have a partial or no response to these treatments. There is currently no possibility of determining the probability of response to treatments in patients.
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It is therefore essential to determine an anatomo-clinico-biological correlation associating the anatomopathological profile, the clinical characteristics and the cytokine signature in order to best guide the patient's management, including the initiation of biotherapy. Indeed, patients, according to their clinical, biological characteristics and the cytokine signature of their polyps will react differently to different treatments, including surgery and biotherapy. This correlation will serve as a predictor of treatment response. conditions: NASAL POLYPS studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: BASIC_SCIENCE masking: NONE count: 200 type: ESTIMATED name: identification anatomo-clinico-biological profiles measure: Identify anatomical profiles present in nasal sinus polyposis resistant to medical treatment. measure: Evaluation of symptoms related to nasal sinus polyposis by visual analogue scale measure: Evaluation to quality of life by Sino-Nasal Outcome Test measure: Identify biological profiles for patients with nasal sinus polyposis measure: Evaluation to cytokine concentration in serum for patients with nasal sinus polyposis sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06362109 id: Once tubefeeding briefTitle: The Impact of Intermittent Nutritional Tube Supplementation in Elderly Patients With Dysphagia overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-12 date: 2024-12 date: 2024-04-12 date: 2024-04-12 name: Zhao Song Ling class: OTHER_GOV briefSummary: This is a prospective, randomized controlled clinical trail involved Elderly Patients With Dysphagia.The goal of this clinical trial is to compare the clinical effect of Intermittent Oro-esophageal Tube Feeding in Elderly Patients With Dysphagia. The main questions it aims to answer:
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Can Intermittent Nutritional Tube Supplementation help improve the nutritional status in Elderly Patients With Dysphagia.
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Participants will be divided into two groups randomly. All patients are given routine rehabilitation and the intervention group is given Intermittent Oro-esophageal Tube Feeding once a day. conditions: Dysphagia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Routine rehabilitation name: Intermittent Oro-esophageal Tube Feeding measure: Nutritional status-prealbumin measure: Nutritional status-albumin measure: Nutritional status-hemoglobin sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06362096 id: pyrotinib diarrhra briefTitle: A Multicenter, Prospective Study of Diarrhea Tolerance of Pyrotinib Combined With Trastumab and Taxane in the First-line Treatment of HER2-positive Advanced Breast Cancer overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-05 date: 2026-05 date: 2024-04-12 date: 2024-04-12 name: Huihua Xiong class: OTHER briefSummary: To explore a reasonable and effective way to reduce the incidence of grade 3 or above diarrhea caused by pyrotinib conditions: Breast Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: PREVENTION masking: NONE count: 72 type: ESTIMATED name: Trastuzumab+pyrotinib+taxene measure: Incidence of ≥ grade 3 diarrhea sex: ALL minimumAge: 17 Years maximumAge: 75 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06362083 id: 34-317 ex 21/22 briefTitle: Urethral Stricture Database overallStatus: RECRUITING date: 2024-01-15 date: 2034-01-15 date: 2034-03-15 date: 2024-04-12 date: 2024-04-12 name: Medical University of Graz class: OTHER briefSummary: Establishment of a clinical urethral stricture database for a prospective longitudinal cohort study. conditions: Urethral Stricture studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 500 type: ESTIMATED name: Questionnaires and data collection measure: Success rate of urethral reconstructive surgeries measure: Complications of urethral reconstructive surgeries measure: Sexual function after urethral reconstructive surgeries measure: Health status after urethral reconstructive surgeries sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Röthl Martina Anna status: RECRUITING city: Graz state: Styria zip: 8036 country: Austria name: Marianne Leitsmann, Prof. Dr. role: CONTACT phone: +43 316 385 80550 email: martina.roethl@medunigraz.at name: Marianne Leitsmann, Prof. Dr. role: PRINCIPAL_INVESTIGATOR lat: 47.06667 lon: 15.45 hasResults: False
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<|newrecord|> nctId: NCT06362070 id: COMPAR-G briefTitle: Comparison of Outcomes of Multiple Platforms for Assisted Robotic - Gastrectomy overallStatus: RECRUITING date: 2024-01-31 date: 2024-03-30 date: 2025-07-31 date: 2024-04-12 date: 2024-04-12 name: Azienda Ospedaliera Universitaria Integrata Verona class: OTHER briefSummary: The object of this exploratory clinical trial is to evaluate intra and post-operative complications in a population that underwent Robotic Gastrectomy, with multiple platforms:
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* DaVinci;
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* Hugo;
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* Versius.
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This study is divided into two phases: in the first phase, gastrectomy will be performed using both the new platforms (Hugo and Versius) and the standard platform (Da Vinci), to evaluate the feasibility of the surgical procedure. In the second phase, the three platforms will be compared to evaluate any differences in the learning curve for an upper-GI surgeon, expert in laparoscopic surgery but not with robotic one.
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The questions it aims to answer are:
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* Are differences (intra-operative, post-operative, oncological, functional, technical, and economic) among the three different platforms observable?
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* Are there any differences between the three platforms related to the learning curve for surgeons?
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Participants will be enrolled, after obtaining informed consent, in one of the following cohorts:
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1. surgery with the daVinci platform;
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2. surgery with the Hugo platform;
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3. surgery with the Versius platform. conditions: Gastric Cancer conditions: Gastrointestinal Cancer conditions: Neoplasms conditions: Gastric Diffuse Adenocarcinoma conditions: Gastric Neoplasm conditions: Stomach Adenocarcinoma studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 75 type: ESTIMATED name: DaVinci® Surgical System name: Hugo™ RAS System name: Versius® Robotic Surgery System measure: Conversion rate to open or laparoscopic approach (Phase 1) measure: Number of participants with major intraoperative complications (Phase 1) measure: Evaluation of surgical times of the standardized procedures (Phase 2) measure: Analysis of video of surgical procedures (Phase 2) measure: Estimated Blood Loss measure: Overall duration of the surgery measure: Anesthesia, Lymphadenectomy, Gastrectomy (10 different surgical steps) measure: Number of participants with major postoperative complications measure: Compliance rate to ERAS protocol measure: Postoperative hospitalization measure: Postoperative pain measure: Re-admission rate to hospitalization measure: Damage due to positioning measure: Positive Surgical Margin measure: Lymph nodes resection measure: Quality of Life Evaluation measure: Time taken for platform-related technical steps measure: Possible malfunction of the platform measure: Non-Technical Skills Assessment (NTS) demonstrated by members of the surgical team during the intraoperative phase. measure: Procedure-related costs sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: General and Upper GI Unit status: RECRUITING city: Verona zip: 37126 country: Italy name: Simone SG Giacopuzzi, MD, Prof role: CONTACT phone: +39 0458127510 email: simone.giacopuzzi@univr.it name: Simone Giacopuzzi, MD, Prof role: PRINCIPAL_INVESTIGATOR name: Maria Bencivenga, MD, Prof role: SUB_INVESTIGATOR lat: 45.4299 lon: 10.98444 hasResults: False
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<|newrecord|> nctId: NCT06362057 id: ADMNF-0020324 briefTitle: Biomechanical Effects of Digitally Constructed Subperiosteal Implants overallStatus: RECRUITING date: 2024-04-04 date: 2024-06-20 date: 2024-07-27 date: 2024-04-12 date: 2024-04-12 name: Menoufia University class: OTHER briefSummary: Subperiosteal implants were first introduced in 1940 and then used worldwide for the treatment of edentulous maxilla or mandible with advanced bone atrophy. conditions: Bone Loss studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: OTHER count: 9 type: ESTIMATED name: Subperiosteal implant framework measure: bone loss under the implants sex: ALL minimumAge: 30 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mohammed A. El-Sawy status: RECRUITING city: Mansoura zip: 12345 country: Egypt name: Mohammed A. El-Sawy, PhD role: CONTACT phone: 161314522 email: Dr_sawy@windowslive.com name: PhD role: CONTACT lat: 31.03637 lon: 31.38069 hasResults: False
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<|newrecord|> nctId: NCT06362044 id: P24-120 briefTitle: A Study to Assess Frequency of Undetectable Minimal Residual Disease (uMRD) in Adult Participants With Chronic Lymphocytic Leukemia (CLL) Receiving Oral Venetoclax Tablets ± Intravenously (IV) Infused Rituximab in Routine Clinical Practice in Japan overallStatus: RECRUITING date: 2023-06-07 date: 2024-12-31 date: 2024-12-31 date: 2024-04-12 date: 2024-04-12 name: AbbVie class: INDUSTRY briefSummary: Most cases of Chronic lymphocytic leukemia (CLL) remain an incurable disease with the goal of therapy being to improve quality of life and to prolong survival. This study will evaluate the participant's related outcomes and experience of CLL in adult participants who are treated in the Japan.
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Study participants will receive oral treatments of Venetoclax±Rituximab for CLL as prescribed by their study doctor in accordance with approved local label. Adult participants prescribed various treatments Venetoclax±Rituximab will be enrolled. Around 89 participants will be enrolled in the study in sites in Japan.
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Participants will receive oral venetoclax tablets ± intravenously (IV) infused rituximab treatments for CLL according to the approved local label. The overall study duration will be 27 months.
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There is expected to be no additional burden for participants in this trial. All study visits will occur during routine clinical practice. conditions: Chronic Lymphocytic Leukemia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 89 type: ESTIMATED measure: Percentage of Participants with Undetectable Minimal Residual Disease (uMRD) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: National Cancer Center Hospital East /ID# 265970 status: RECRUITING city: Kashiwa state: Chiba zip: 277-8577 country: Japan lat: 35.86224 lon: 139.97732 hasResults: False
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<|newrecord|> nctId: NCT06362031 id: H18.Oncology.12-SR1812 briefTitle: A Study to Explore Treatment Patterns, Treatment Outcomes, Healthcare Resource Utilization in Adult Participants With Acute Myeloid Leukemia (AML) Receiving Venetoclax Through Chart Review overallStatus: WITHDRAWN date: 2023-06-01 date: 2024-04-30 date: 2024-04-30 date: 2024-04-12 date: 2024-04-12 name: AbbVie class: INDUSTRY briefSummary: Acute myeloid leukemia (AML), also referred to as acute myelogenous leukemia or acute non-lymphocytic leukemia, is a relatively rare, yet aggressive, type of cancer. This study will evaluate treatment patterns, treatment outcomes, healthcare resource utilization in adult participants with AML receiving venetoclax.
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Data from up to 700 participants will be collected. No participants will be enrolled in this study.
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Participants' charts will be reviewed. No drug will be administered as a part of this study. The duration of the observation period is up to 10 months.
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There is no additional burden for participants in this trial. All visits must be completed prior to data extraction and participants will be followed for up to 10 months. conditions: Acute Myeloid Leukemia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 0 type: ACTUAL measure: Overall Survival (OS) measure: Event-free survival (EFS) measure: Percentage of Participants Achieving Best Overall Response measure: Duration of Response (DoR) measure: Percentage of Participants with Transfusion Independence (TI) measure: Number of Participants with Healthcare Resource Utilization (HRU) sex: ALL minimumAge: 18 Years maximumAge: 89 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06362018 id: MHC/CT/23-24/055 id: MHC/CT/23-24/055, Version No.: type: OTHER domain: Mprex Healthcare Pvt. Ltd. briefTitle: Bioavailability of Three Mitopure Formulations overallStatus: NOT_YET_RECRUITING date: 2024-04-09 date: 2024-05-31 date: 2024-06-30 date: 2024-04-12 date: 2024-04-12 name: Amazentis SA class: INDUSTRY name: Mprex Healthcare Pvt. Ltd. briefSummary: This study's design as an open-label, single-dose, randomized trial that aligns with the objective of characterizing the concentration-time profiles of three Urolithin A (Mitopure) formulations in a controlled setting. The inclusion criteria, stringent fasting requirements, standardized fluid intake and strict dietary restriction protocols ensure homogeneity among the study participants, enhancing the reliability of the outcomes.
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Ultimately, this clinical trial aims to contribute valuable insights into the pharmacokinetic behavior of the different Urolithin A formulations, facilitating informed decisions for future developments and applications in the realm of health and wellness. conditions: Healthy Adults studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: NONE count: 36 type: ESTIMATED name: Mitopure (Urolithin A) measure: Plasma concentrations of Urolithin A over time and maximal plasma concentration (Cmax) measure: Exposure to Urolithin A over time measured as area under the curve (AUC) measure: Number of adverse events and serious adverse events throughout the study. sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Lokmanya Medical Research Centre and Hospital city: Pune zip: 411033 country: India name: Dr Ramshyam Agarwal, MD role: CONTACT lat: 18.51957 lon: 73.85535 hasResults: False
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<|newrecord|> nctId: NCT06362005 id: AUAREC2023011-1 briefTitle: The Efficacy of Selenium as an Alternative or Complementary Topical Treatment of Oral Lichen Planus acronym: RCT overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2024-10-01 date: 2025-03-01 date: 2024-04-12 date: 2024-04-23 name: Al-Azhar University class: OTHER name: Sphinx university briefSummary: evaluate clinically and biochemically the efficacy of topically applied selenium as complementary or alternative to triamcinolone acetonide 0.1% and tacrolimus 0.1% in patients with oral lichen planus. conditions: Lichen Planus, Oral studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 20 type: ESTIMATED name: Triamcinolone Acetonide 0.1% Oint name: Tacrollimus Topical name: Selenium name: Selenium & Triamcinolone Acetonide 0.1% Oint name: Selenium& Tacrollimus topical measure: to assess a visual analog scale (VAS)of the oral lichen planus lesion measure: to assess The associated Oral Disease Severity Score 3- Glutathione biomarker level as an antioxidant enzyme in saliva by ELISA analysis measure: Biochemical evaluation of salivary Glutathione level using (ELISA) sex: ALL minimumAge: 20 Years maximumAge: 55 Years stdAges: ADULT facility: Alazhar university ,faculty of Dental Medicine city: Assiut zip: 0000 country: Egypt lat: 27.18096 lon: 31.18368 hasResults: False
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<|newrecord|> nctId: NCT06361992 id: BC_SERBIA_2022 briefTitle: Efficacy and Safety of Blue Cap for the Treatment of Atopic Dermatitis in Children overallStatus: COMPLETED date: 2022-03-15 date: 2023-09-15 date: 2024-02-13 date: 2024-04-12 date: 2024-04-15 name: Catalysis SL class: INDUSTRY briefSummary: To verify the efficacy and tolerability of Activated Piroctone Olamine (Blue Cap Foam, label volume 100 ml) by CATALYSIS, S. L. Madrid, applied in the management of all types of dermatitis (atopic, seborrheic, eczema) in patients with significant manifestations of the disease in varying areas of the body of varying extent and to assess differences in individual tolerability and the final effect in a group of selected patients aged 3 to 18 years. conditions: Atopic Dermatitis conditions: Atopic Dermatitis and Related Conditions conditions: Atopic Dermatitis Eczema conditions: Atopic Dermatitis \(AD\) studyType: INTERVENTIONAL phases: PHASE3 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 58 type: ACTUAL name: Blue Cap Foam measure: Grade of Patient Tolerability to the investigation product measure: Clinical Improvement of Patients with Dermatitis measure: Clinical assessment of symptoms and sings associated with Dermatitis measure: Evaluation of the therapeutic effect of Blue Cap in paediatric patients with dermatitis. measure: Evaluation of the therapeutic effect of Blue Cap on healing of the skin at the patients sex: ALL minimumAge: 3 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: University of Niš Faculty of Medicine, Department of Dermatology and Venereology, University Clinical Center of Niš city: Niš state: Nišava zip: 18108 country: Serbia lat: 43.32472 lon: 21.90333 facility: City Institute for Skin and Venereal Diseases Belgrade city: Belgrade zip: 11000 country: Serbia lat: 44.80401 lon: 20.46513 facility: University of Belgrade Faculty of Medicine, University Clinical Center of Serbia city: Belgrade zip: 11000 country: Serbia lat: 44.80401 lon: 20.46513 hasResults: False
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<|newrecord|> nctId: NCT06361979 id: A1811 briefTitle: SHR-A1811 Combined With Bevacizumab in HER2-positive Breast Cancer With Brain Metastases overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-05 date: 2026-05 date: 2024-04-12 date: 2024-04-12 name: Huihua Xiong class: OTHER briefSummary: This study aimed to evaluate the use of SHR-A1811 and bevacizumab in HER2-positive Breast Cancer with brain metastases conditions: Breasr Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: SHR-A1811 name: Bevacizumab measure: CNS-ORR measure: PFS measure: ORR measure: AE sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06361966 id: 2021/00638 briefTitle: Evaluating User Satisfaction and Feasibility of a Remote Model for 3d Scanned and Printed Transtibial Prosthetic Sockets overallStatus: COMPLETED date: 2022-01-11 date: 2023-01-09 date: 2023-01-09 date: 2024-04-12 date: 2024-04-12 name: Tan Tock Seng Hospital class: OTHER name: Prosfit Technologies JSC name: Centre for Allied Health and Pharmacy Excellence (CAPE) briefSummary: The goal of this clinical trial is to investigate the repeatability of application of a fully remote method of manufacturing 3D printing of prosthetic sockets for transtibial amputees, and determine user satisfaction of sockets produced through these methods. The study also aims to evaluate the time and cost effectiveness of this production model.
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The main question\[s\] it aims to answer are:
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1. To determine the repeatability and user satisfaction with transtibial sockets produced using a remote-digital method as compared to conventional manufacturing methods.
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2. To determine if transtibial prosthetic users have greater prosthetic satisfaction scores across the 4 Prosthesis Evaluation Questionnaire (PEQ) subscales of Utility (UT), Appearance (AP), Sounds (SO) and Residual Limb Health (RL) with the 3D printed socket fabricated through the remote-digital method compared to the laminate socket made using the conventional method.
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3. To determine if transtibial prosthetic users experience greater socket comfort with the 3D printed socket compared to the laminate socket.
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Participants will receive a 3D printed socket (trial intervention) and a laminate socket (control intervention) and will use each socket for a period of 4 weeks.The order of socket use will be randomised. At the end of each 4 week period, participants will rate their comfort and satisfaction with the socket. At the end of the trial, participants will indicate their preferred socket, which will be fitted to their prosthesis.
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Participants will attend 6 visits across a total duration of 11 weeks during the course of the study. conditions: Amputation conditions: Prosthesis User studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: NONE count: 16 type: ACTUAL name: 3d printed prosthetic socket measure: Prosthesis Evaluation Questionnaire measure: Socket Comfort Score sex: ALL minimumAge: 21 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tan Tock Seng Hospital city: Singapore zip: 308433 country: Singapore lat: 1.28967 lon: 103.85007 hasResults: False
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<|newrecord|> nctId: NCT06361953 id: IR.SBMU.MSP.REC. 1401. 161 briefTitle: Comparing the Efficacy of Two Neurofeedback Protocols for Generalized Anxiety Disorder overallStatus: COMPLETED date: 2022-06-01 date: 2023-07-01 date: 2023-07-01 date: 2024-04-12 date: 2024-04-12 name: Shahid Beheshti University of Medical Sciences class: OTHER briefSummary: Generalized anxiety disorder (GAD) is one of the most prevalent mental disorders in adults, marked by excessive and uncontrollable worry about various events or activities. It is accompanied by symptoms such as restlessness, irritability, fatigue, difficulty concentrating, problems with sleep, and somatic symptoms.
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In addition, a critical and up-to-date comparison of different treatments for GAD is crucial due to their high costs and unsatisfactory outcomes. EEG neurofeedback training has not reached the same level of evidence as more extensively validated non-pharmacological treatments, such as cognitive behavioral therapy.This study aimed to compare the efficacy of two protocols: one targeting alpha-theta amplitude increase and the other concentrating on SMR. conditions: Generalized Anxiety Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 40 type: ACTUAL name: EEG Neurofeedback measure: The Beck Anxiety Inventory measure: The Perceived Stress Questionnaire measure: Spielberger's state-trait anxiety test sex: ALL minimumAge: 20 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Shahid Beheshti University of Medical Science city: Tehran zip: 4739-19395 country: Iran, Islamic Republic of lat: 35.69439 lon: 51.42151 hasResults: False
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<|newrecord|> nctId: NCT06361940 id: IIT-CHAUDHARY-ENDOCRINE2-OPP briefTitle: Molecular Analyses to Identify Pathways of Endocrine Resistance Following Short Term Neoadjuvant Endocrine Treatment in Patients With Hormone Receptor-Positive HER2-negative Breast Cancer overallStatus: NOT_YET_RECRUITING date: 2024-08 date: 2028-12 date: 2029-12 date: 2024-04-12 date: 2024-04-15 name: Medical College of Wisconsin class: OTHER briefSummary: This is an exploratory phase II interventional study that initiates standard-of-care anti-estrogen treatment preoperatively for 4-12 weeks (+/- 2 weeks). conditions: Breast Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 100 type: ESTIMATED name: Aromatase inhibitors or tamoxifen measure: Change from baseline in the number of subjects with increased HER-1 receptor tyrosine kinases protein expression in tumors. measure: Change from baseline in the number of subjects with increased HER-2 receptor tyrosine kinases protein expression in tumors. measure: Change from baseline in the number of subjects with increased HER-3 receptor tyrosine kinases protein expression in tumors. measure: Change from baseline in the number of subjects with increased HER-4 receptor tyrosine kinases protein expression in tumors. sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Froedtert Hospital and the Medical College of Wisconsin city: Milwaukee state: Wisconsin zip: 53226 country: United States name: Lubna N Chaudhary, MD role: CONTACT email: lchaudhary@mcw.edu lat: 43.0389 lon: -87.90647 hasResults: False
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<|newrecord|> nctId: NCT06361927 id: SSGJ-707-NSCLC-II-01 briefTitle: A Phase II Study of SSGJ-707 Monotherapy in First-line PD-L1 Positive Advanced NSCLC Patients overallStatus: RECRUITING date: 2024-05 date: 2025-06 date: 2025-07 date: 2024-04-12 date: 2024-04-12 name: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. class: INDUSTRY briefSummary: This study includes two cohorts, cohort A is for non-squamous NSCLC and cohort B is for squamous NSCLC. conditions: NSCLC studyType: INTERVENTIONAL phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 120 type: ESTIMATED name: SSGJ-707 measure: ORR measure: Safety and tolerability sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Hunan Cancer Hospital status: RECRUITING city: Changsha state: Hunan country: China name: Lin Wu, MD,Ph.D role: CONTACT phone: 0731-89762302 email: wulin-calf@vip.163.com lat: 28.19874 lon: 112.97087 hasResults: False
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<|newrecord|> nctId: NCT06361914 id: 2314393 briefTitle: Digital CBT-I for Patients With Chronic Pain and Insomnia acronym: Back2Sleep overallStatus: RECRUITING date: 2024-04-12 date: 2026-03-01 date: 2026-09-01 date: 2024-04-12 date: 2024-04-18 name: Odense University Hospital class: OTHER name: Aarhus University Hospital name: University of Southern Denmark name: University of Aarhus name: Odense Patient Data Explorative Network name: T&W Engineering A/S briefSummary: Chronic pain constitutes an increasing health and social burden. More than 50% of patients with chronic pain report insomnia, and patients with comorbid insomnia often report stronger and widespread pain, compared to those who are sleeping well. Sleep disturbances are often considered a consequence to chronic pain. This means that insomnia is often overlooked or ineffectively managed with hypnotics or advice on sleep hygiene. Therefore, efficacious, easily accessible, and safe alternatives to the current pharmacological treatments for patients with chronic pain and insomnia are needed. Cognitive behavioral therapy for insomnia (CBT-I) is a cost-effective and safe treatment for insomnia and is recommended as first-line treatment. While highly efficacious, the challenge is to deliver CBT-I to those in need. The main barriers of face-to-face delivered CBT-I are availability of trained therapists, costs, as well as physical and geographical constraints.
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The primary aim of this randomized controlled clinical superiority trial is to investigate whether digitally-delivered CBT-I has a greater effect on insomnia and pain than digitally-delivered sleep hygiene education in patients with chronic pain and comorbid insomnia.
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Secondary objectives are to a) explore whether the pain-relieving effect is mediated by a change in physiological markers of sleep quality, b) whether health care cost and use of medications at 12 months are reduced after digital CBT-I, and c) to explore the effectiveness of digital CBT-I compared with sleep hygiene education on:
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1. Physiological sleep metrics (recorded with ear EEG in subsample of 60 patients).
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2. Self-reported sleep quality.
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3. Quality of life.
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4. Physical and mental health.
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5. Thoughts and beliefs about sleep and pain. conditions: Chronic Pain conditions: Insomnia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 160 type: ESTIMATED name: Digital CBT-I name: Digital Sleep hygiene education measure: Insomnia severity measure: Average pain intensity during the last 7 days measure: The trajectory of ISI severity scores measure: 30% ISI responders measure: 50% ISI responders measure: Weekly pain intensity score trajectory measure: 30% pain intensity responders measure: 50% pain intensity responders measure: Global Perceived Effect (GPE) for sleep measure: Global Perceived Effect (GPE) for pain measure: Sleep Quality measure: Physical and Mental Health measure: Sleep diary measure: Thoughts about sleep and pain measure: Thoughts about sleep measure: Treatment compliance measure: Health-related quality of life - mobility measure: Health-related quality of life - self care measure: Health-related quality of life - usual activities measure: Health-related quality of life - pain/discomfort measure: Health-related quality of life - anxiety/depression measure: Health-related quality of life - global measure: Age measure: Sex measure: Chronic pain measure: Ethnicity measure: Height measure: Weight measure: Marital status measure: Level of education measure: Pain distribution measure: Medical history and concomitant illnesses measure: Concomitant medication measure: Health-related quality of life - mobility measure: Health-related quality of life - self care measure: Health-related quality of life - usual activities measure: Health-related quality of life - pain/discomfort measure: Health-related quality of life - anxiety/depression measure: Health-related quality of life - global measure: Insomnia Severity measure: Average pain intensity during the last 7 days measure: Medication use measure: Economical evaluation measure: Time from sleep onset until final awakening (TST) from Ear EEG in subgroup of 60 patients measure: Sleep efficiency (SE) from Ear EEG in subgroup of 60 patients measure: Sleep onset latency (SOL) from Ear EEG in subgroup of 60 patients measure: Wake after sleep onset (WASO) from Ear EEG in subgroup of 60 patients measure: REM sleep latency from Ear EEG in subgroup of 60 patients measure: Time from sleep onset until first epoch of REM stage sleep from Ear EEG measure: Amount of wake and stage N1, N2, N3, and R sleep as a percentage of SPT from Ear EEG measure: Number of awakenings within TST from Ear EEG measure: Arousal index which is number of arousals per hour from Ear EEG measure: Ease-of-use and Comfort with ear EEG measure: Ear EEG adverse device effects sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Pain Center, Department of Anesthesiology and Intensive Care Medicine, University Hospital Odense status: RECRUITING city: Odense zip: 5000 country: Denmark name: Henrik B Vaegter, PhD role: CONTACT phone: 004565413869 email: hbv@rsyd.dk name: Louise S Olsen, MSc role: CONTACT phone: 004565413869 email: Maria.Louise.Stage.Olsen@rsyd.dk name: Henrik B Vægter, PhD role: PRINCIPAL_INVESTIGATOR name: Louise S Olsen, MSc role: SUB_INVESTIGATOR lat: 55.39594 lon: 10.38831 hasResults: False
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<|newrecord|> nctId: NCT06361901 id: 2023GR0452 briefTitle: Comparison of Therapeutic Effect Between Speech Rehabilitation Program and Speech Therapy in Stroke Patients With Aphasia overallStatus: RECRUITING date: 2023-11-17 date: 2024-12 date: 2024-12 date: 2024-04-12 date: 2024-04-12 name: Korea University Guro Hospital class: OTHER briefSummary: Our study will provide precise and intensive speech rehabilitation treatment program to patients with speech disorders after stroke, and compare clinical evaluations with the conventional speech therapy patient group.
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Clinical evaluation tools will be performed before and after the treatment for all patients
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* K-Western Aphasia Battery for aphasia assessment tools
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* Cerebral blood flow changes with near-infrared spectroscopy conditions: Stroke conditions: Aphasia conditions: Speech Therapy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 20 type: ESTIMATED name: Zenicog;language rehabilitation program name: Conventional language rehabilitation measure: Aphasic quatient measure: Change of cerebral blood flow sex: ALL minimumAge: 19 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Rehabilitation Medicine, Korea University Guro Hospital status: RECRUITING city: Seoul zip: 08308 country: Korea, Republic of name: Seung Nam Yang, MD, PhD role: CONTACT phone: 82-2-2626-1500 email: snamyang@korea.ac.kr lat: 37.566 lon: 126.9784 hasResults: False
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<|newrecord|> nctId: NCT06361888 id: 2023-012-00CH1 briefTitle: A Phase II/III Trial to Evaluate the Efficacy and Safety of Surufatinib Combined With Camrelizumab, Nab-paclitaxel, and Gemcitabine in Metastatic Pancreatic Cancer overallStatus: NOT_YET_RECRUITING date: 2024-05-31 date: 2027-08-31 date: 2027-08-31 date: 2024-04-12 date: 2024-04-12 name: Hutchmed class: INDUSTRY briefSummary: To evaluate the efficacy of Surufatnib combined withcamrelizumab, nab-paclitaxel, and gemcitabine versus nab-paclitaxel plus gemcitabine as the first-line treatment in metastatic pancreatic cancer conditions: Metastatic Pancreatic Cancer studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 482 type: ESTIMATED name: Surufatinib Combined With Camrelizumab, Nab-paclitaxel, and Gemcitabine name: Nab-paclitaxel Plus Gemcitabine name: Surufatinib with Nab-paclitaxel, and Gemcitabine measure: Overall Survival (OS) measure: Progression-free Survival (PFS) (RECIST1.1) measure: Objective response rate (ORR)(RECIST1.1) measure: Duration of response (DoR)(RECIST1.1) measure: Disease control rate (DCR)(RECIST1.1) measure: Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30) measure: Cancer Quality of Life Questionnaire - PAN26(EORTC QLQ-PAN26) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Nanjing Tianyinshan Hospital city: Nanjing state: Jiang Su zip: 210000 country: China name: Shukui Qin, Prof. role: CONTACT lat: 32.06167 lon: 118.77778 facility: Tianjin Cancer Hospital city: Tianjin state: Tianjin zip: 300000 country: China name: Jihui Hao, Prof. role: CONTACT lat: 39.14222 lon: 117.17667 hasResults: False
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<|newrecord|> nctId: NCT06361875 id: VAV00045 id: U1111-1295-2852 type: REGISTRY domain: ICTRP briefTitle: A Study to Investigate the Safety and Immunogenicity of the Quadrivalent Influenza mRNA Vaccines in Adults Aged 18 Years and Above overallStatus: RECRUITING date: 2024-04-01 date: 2025-05-22 date: 2025-05-22 date: 2024-04-12 date: 2024-04-12 name: Sanofi Pasteur, a Sanofi Company class: INDUSTRY briefSummary: The purpose of this study is to evaluate the safety and immunogenicity of a single intramuscular (IM) injection of different formulations of Quadrivalent Influenza Vaccine (QIV) messenger ribonucleic acid (mRNA) (MRT5421, MRT5424, and MRT5429) compared to an active control (QIV- standard dose (SD), QIV- high dose (HD) \[adults ≥ 65 years of age only\], or quadrivalent recombinant influenza vaccine (RIV4)) in adults 18 years of age and older. conditions: Influenza Immunization studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Parallel with dose escalation for sentinel cohort primaryPurpose: PREVENTION masking: TRIPLE maskingDescription: Modified double-blind (Participants; Sites except for those preparing/administering study intervention; Sponsor's except Sponsor unblinded internal safety review committee) whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 1002 type: ESTIMATED name: Quadrivalent Influenza mRNA Vaccine MRT5421 name: Quadrivalent Influenza mRNA Vaccine MRT5424 name: Quadrivalent Influenza mRNA Vaccine MRT5429 name: Quadrivalent Influenza Standard Dose Vaccine name: Quadrivalent Influenza High-Dose Vaccine name: Quadrivalent Recombinant Influenza Vaccine measure: Number of participants with immediate unsolicited systemic adverse events (AEs) measure: Number of participants with solicited injection site reactions measure: Number of participants with solicited systemic reactions measure: Number of participants with unsolicited AEs measure: Number of participants with medically attended adverse events (MAAEs) measure: Number of participants with serious adverse events (SAEs) measure: AESIs reported throughout the study measure: Number of participants with adverse events of special interests (AESIs) measure: Number of participants with out-of-range biological test results measure: Geometric Mean Titer (GMT) measure: Geometric Mean of individual Titer Ratio (GMTR) measure: Seroconversion measure: HAI Ab titer ≥ 40 (1/dil) measure: Neutralizing Ab titers at D01 and D29 measure: Individual neutralizing antibodies titer ratio measure: 2-fold and 4-fold increase in neutralizing titers sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Velocity Clinical Research Site Number : 8400048 status: RECRUITING city: La Mesa state: California zip: 91942 country: United States lat: 32.76783 lon: -117.02308 facility: California Research Foundation Site Number : 8400038 status: RECRUITING city: San Diego state: California zip: 92123-1881 country: United States lat: 32.71533 lon: -117.15726 facility: Accel Clinical Research-Deland Clinical Research Unit Site Number : 8400001 status: RECRUITING city: DeLand state: Florida zip: 32720-0834 country: United States lat: 29.02832 lon: -81.30312 facility: Indago Research and Health Center Site Number : 8400032 status: RECRUITING city: Hialeah state: Florida zip: 33012 country: United States lat: 25.8576 lon: -80.27811 facility: Research Centers of America Site Number : 8400037 status: RECRUITING city: Hollywood state: Florida zip: 33024 country: United States lat: 26.0112 lon: -80.14949 facility: Suncoast Research Group, LLC Site Number : 8400015 status: RECRUITING city: Miami state: Florida zip: 33135 country: United States lat: 25.77427 lon: -80.19366 facility: Brengle Family Medicine Site Number : 8400045 status: RECRUITING city: Indianapolis state: Indiana zip: 46260 country: United States lat: 39.76838 lon: -86.15804 facility: AMR Lexington Site Number : 8400042 status: RECRUITING city: Lexington state: Kentucky zip: 40509 country: United States lat: 37.98869 lon: -84.47772 facility: Velocity Clinical Research Site Number : 8400053 status: RECRUITING city: Metairie state: Louisiana zip: 70006 country: United States lat: 29.98409 lon: -90.15285 facility: Optimal Research, LLC Rockville Site Number : 8400025 status: RECRUITING city: Rockville state: Maryland zip: 20850 country: United States lat: 39.084 lon: -77.15276 facility: The Alliance for Multispecialty Research - KCM, LLC Site Number : 8400034 status: RECRUITING city: Kansas City state: Missouri zip: 64114 country: United States lat: 39.09973 lon: -94.57857 facility: Velocity Clinical Research Norfolk Site Number : 8400046 status: RECRUITING city: Norfolk state: Nebraska zip: 68701 country: United States lat: 42.02834 lon: -97.417 facility: Velocity Clinical Research, Omaha Site Number : 8400008 status: RECRUITING city: Omaha state: Nebraska zip: 68134 country: United States lat: 41.25626 lon: -95.94043 facility: Rochester Clinical Research. Inc. Site Number : 8400005 status: RECRUITING city: Rochester state: New York zip: 14609 country: United States lat: 43.15478 lon: -77.61556 facility: Aventiv Research Columbus Site Number : 8400020 status: RECRUITING city: Columbus state: Ohio zip: 43213 country: United States lat: 39.96118 lon: -82.99879 facility: Coastal Carolina Research Center Site Number : 8400014 status: RECRUITING city: North Charleston state: South Carolina zip: 29405 country: United States lat: 32.85462 lon: -79.97481 facility: AMR Knoxville Site Number : 8400043 status: RECRUITING city: Knoxville state: Tennessee zip: 37909 country: United States lat: 35.96064 lon: -83.92074 facility: Clinical Trials of Texas, Inc. - PPDS Site Number : 8400029 status: RECRUITING city: San Antonio state: Texas zip: 78229 country: United States lat: 29.42412 lon: -98.49363 facility: DM Clinical Research/Pediatric Healthcare of Northwest Houston Site Number : 8400056 status: RECRUITING city: Tomball state: Texas zip: 77375 country: United States lat: 30.09716 lon: -95.61605 facility: JBR Clinical Research Site Number : 8400051 status: RECRUITING city: Salt Lake City state: Utah zip: 84107 country: United States lat: 40.76078 lon: -111.89105 facility: Investigational Site Number : 6300002 status: RECRUITING city: Barrio Sabana zip: 00694 country: Puerto Rico hasResults: False
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<|newrecord|> nctId: NCT06361862 id: WARD - Overtreatment briefTitle: Does Continuous Vital Sign Monitoring Increase Investigations and Interventions in Complication-free Patients? acronym: WARD-OT overallStatus: RECRUITING date: 2024-01-01 date: 2025-03-01 date: 2025-04-01 date: 2024-04-12 date: 2024-04-12 name: Rigshospitalet, Denmark class: OTHER name: Bispebjerg Hospital briefSummary: This aim of this study is to investigate whether active alerts during CVSM result in an increased number of diagnostic tests and treatments in complication free patients, hypothesizing that more interventions are performed in the CVSM-group than standard of care (EWS) group. conditions: Cancer conditions: Chronic Obstructive Pulmonary Disease conditions: Surgery-Complications studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 700 type: ESTIMATED name: Active alarms from WARD software measure: Frequency of patients having at least one of the following tests/treatments: measure: The frequency of individual treatments and diagnostics: sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Eske Kvanner Aasvang status: RECRUITING city: Copenhagen zip: 2100 country: Denmark name: Eske K Aasvang, M.D., DMSci role: CONTACT phone: +4526232076 email: eske.kvanner.aasvang.01@regionh.dk lat: 55.67594 lon: 12.56553 hasResults: False
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<|newrecord|> nctId: NCT06361849 id: 55013 briefTitle: TauTona Pneumoperitoneum Assist Device (TPAD) acronym: TPAD overallStatus: ENROLLING_BY_INVITATION date: 2024-01-01 date: 2024-12-31 date: 2025-06-01 date: 2024-04-12 date: 2024-04-24 name: Stanford University class: OTHER name: TauTona Group briefSummary: The purpose of this study is to assess the safety and ease of use of a trocar placement access device (TPAD) to assist with obtaining peritoneal access with a Veress needle, and for placing a primary trocar, during laparoscopic surgery. conditions: Laparoscopic Surgery studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: DEVICE_FEASIBILITY masking: NONE count: 10 type: ESTIMATED name: Trocar Placement Assist Device (TPAD) measure: Surgeon satisfaction survey measure: Time required to obtain peritoneal access and place primary trocar during laparoscopic surgery measure: Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v4.0 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Stanford Hospital & Clinics city: Palo Alto state: California zip: 94305 country: United States lat: 37.44188 lon: -122.14302 hasResults: False
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<|newrecord|> nctId: NCT06361836 id: SBT777101-02 briefTitle: Study of Single Doses of SBT777101 in Subjects With Hidradenitis Suppurativa overallStatus: RECRUITING date: 2024-05 date: 2026-06 date: 2026-06 date: 2024-04-12 date: 2024-04-12 name: Sonoma Biotherapeutics, Inc. class: INDUSTRY briefSummary: This study will test the safety and effects of SBT777101 when given as a single dose to subjects with hidradenitis suppurativa. Increasing dose levels will be given after the safety at lower dose levels is shown. conditions: Hidradenitis Suppurativa studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: Sequential escalating dose cohorts primaryPurpose: TREATMENT masking: NONE count: 24 type: ESTIMATED name: SBT777101 measure: Incidence, nature, and severity of adverse events [Safety and Tolerability] measure: Incidence and nature of Dose Limiting Toxicities [DLTs] sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Brigham and Women's Hospital status: RECRUITING city: Boston state: Massachusetts zip: 02115 country: United States name: Oliva Gabriel role: CONTACT phone: 617-525-8250 email: ogabriel@bwh.harvard.edu lat: 42.35843 lon: -71.05977 hasResults: False
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<|newrecord|> nctId: NCT06361823 id: IIH-Semaglutide briefTitle: Exploratory Study on the Efficacy and Safety of Semaglutide for Idiopathic Intracranial Hypertension Treatment overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-12-01 date: 2025-01-01 date: 2024-04-12 date: 2024-04-12 name: Capital Medical University class: OTHER briefSummary: This study aims to investigate the safety and efficacy of semaglutide in patients with Idiopathic intracranial hypertension. conditions: Idiopathic Intracranial Hypertension studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The researchers are tasked with adhering to the protocol requirements when selecting participants, and consistently enrolling eligible patients who are then randomly assigned to either the experimental or control group in a 1:1 ratio. The randomization process is overseen by expert statisticians and executed by specialized clinical researchers in an independent manner. primaryPurpose: TREATMENT masking: NONE count: 74 type: ESTIMATED name: Semaglutide name: Low calorie diet measure: Intracranial pressure measure: Adverse reactions measure: Headache severity measure: Degree of papilledema measure: Perimetric mean deviation measure: Optic nerve sheath diameter measure: Body mass index sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06361810 id: IRB00430008 briefTitle: PSMA Therapy and Immunotherapy in Kidney Cancer overallStatus: NOT_YET_RECRUITING date: 2024-07 date: 2030-07 date: 2031-07 date: 2024-04-12 date: 2024-04-12 name: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins class: OTHER name: Merck Sharp & Dohme LLC name: Lantheus Medical Imaging briefSummary: This is a multi-center, single arm open label phase 1b/2 study of pembrolizumab in combination with 177Lu-PNT2002 (also known as 177Lu-PSMA I\&T) radiopharmaceutical therapy in patients with metastatic clear cell renal cell carcinoma (RCC) who have progressed after prior treatment with anti-programmed cell death protein 1 (PD1) or PD-L1 immune-checkpoint inhibitors (ICIs). The study comprises 2 phases: an open-label Phase 1b dose escalation portion followed by a Phase 2 dose expansion portion. Investigators hypothesize that pembrolizumab in combination with 177Lu-PNT2002 in in patients with metastatic clear cell RCC at a biologically active dose will result in tolerable safety profile and it will lead to improved radiological objective responses in patients who have progressed after prior treatment with standard anti-PD1 or anti- Programmed Cell Death Ligand 1 (PDL1) immune-checkpoint inhibitor containing regimen when compared to historic controls. Patients in both phases will have prostate-specific membrane antigen (PSMA), positron emission tomography (PET) imaging with the radiotracer (F-18)-DCFPyl, to help detect any spread of the cancer. conditions: Metastatic Renal Cell Carcinoma conditions: Metastatic Clear Cell Renal Cell Carcinoma studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 37 type: ESTIMATED name: Pembrolizumab name: 177Lu-PNT2002 name: (F-18)-DCFPyL measure: Safety assessed by the incidence of dose limiting toxicities. measure: Objective response rate by RECIST 1.1 criteria measure: Progression free survival measure: Safety as assessed by number of participants experiencing adverse events measure: Disease control rates measure: Duration of response to study therapy measure: Overall survival rate sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06361797 id: IRB00415412 briefTitle: Varying Bone Marrow-Derived Mesenchymal Stem Cells Concentrations' Impact on Rotator Cuff Repair Outcomes overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-05 date: 2027-10 date: 2024-04-12 date: 2024-04-12 name: Johns Hopkins University class: OTHER name: ON Foundation briefSummary: Randomized controlled trial comparing benefits of varying amounts of proximal humerus-derived bone marrow aspirate and bone marrow concentrate in rotator cuff repair. conditions: Rotator Cuff Tears studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This study is designed as a parallel group 1:1:1 randomized controlled trial. primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Patients and research assistants collecting data will be unaware of assigned treatment until study completion. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 150 type: ESTIMATED name: Rotator cuff repair augmented with whole bone marrow name: Rotator cuff repair augmented with concentrated bone marrow measure: Number of Rotator cuff re-tears as assessed by magnetic resonance imaging measure: American Shoulder and Elbow Surgeons Score measure: Visual Analogue Pain Score measure: Subjective Shoulder Value score measure: Comprehensive Shoulder Assessment measure: Revision surgery rate measure: Rate of oral and/or intra-articular corticosteroid required sex: ALL minimumAge: 20 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Johns Hopkins Howard County General Hospital city: Columbia state: Maryland zip: 21230 country: United States name: Study Director role: CONTACT name: Principal Investigator role: CONTACT lat: 39.24038 lon: -76.83942 facility: Johns Hopkins Medicine - Green Spring Station city: Lutherville state: Maryland zip: 21093 country: United States name: Matthew J Best, MD role: CONTACT phone: 443-997-2663 email: mbest8@jh.edu name: Uma Srikumaran, MD, MBA, MPH role: CONTACT phone: 410-546-1550 email: us@jhmi.edu lat: 39.42122 lon: -76.62608 hasResults: False
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<|newrecord|> nctId: NCT06361784 id: INT216-23 id: MFAG27480 type: OTHER_GRANT domain: AIRC Foundation for Cancer Research in Italy briefTitle: Improving the Success Rate for Thoracic Radiotherapy Through Specific Cardiac Substructure Dosimetry: Location Matters. (LOCATION MATTERS) acronym: LM overallStatus: RECRUITING date: 2024-03-29 date: 2029-03-29 date: 2029-03-29 date: 2024-04-12 date: 2024-04-15 name: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano class: OTHER name: Politecnico di Milano briefSummary: The prospective study LOCATION MATTERS aims to investigate the radiation-induced damage to the heart and the cardiovascular system in patients treated with thoracic radiotherapy. Patients enrolled in the study will complete a set of extensive measures at the baseline, end of RT, and 9 months after treatment. Ultrasound exams, CT scans, pulmonary tests and wearable devices will assess functional and morphological parameters and the association with their variation and the dose delivered to the heart substructures and to the normal lung. conditions: Locally Advanced Lung Non-Small Cell Carcinoma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 150 type: ESTIMATED measure: Variation in eco-cardio and eco-vascular parameters after thoracic radiotherapy measure: Major adverse cardiac events post-RT measure: Increase in cardiac calcification after RT measure: Longitudinal variation of cardiopulmonary functional parameters measure: Texture variation in the heart substructures sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Fondazione IRCCS Istituto Nazionale dei Tumori status: RECRUITING city: Milan zip: 20133 country: Italy name: Alessandro Cicchetti, PhD role: CONTACT phone: 0223903858 email: alessandro.cicchetti@istitutotumori.mi.it name: Chiara Casati role: CONTACT email: chiara.casati@istitutotumori.mi.it name: Alessandro Cicchetti, PhD role: PRINCIPAL_INVESTIGATOR lat: 45.46427 lon: 9.18951 hasResults: False
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<|newrecord|> nctId: NCT06361771 id: 29BRC24.0079 - PRICELESS briefTitle: Evaluation of Invisible Preparation Behaviors of Middle and High School Students in Sports Facilities (PRICELESS) acronym: PRICELESS overallStatus: RECRUITING date: 2024-01-08 date: 2024-12-20 date: 2024-12-20 date: 2024-04-12 date: 2024-04-18 name: University Hospital, Brest class: OTHER briefSummary: The investigators define the Invisible Preparation (IP) as the set of health behaviors that young athletes implement, on their own, to optimize their health and performances. This includes sleep, nutrition and hydration, physical well-being (injuries prevention) and mental well-being. If some studies have reported a lack of compliance in young athletes regarding sleep and hydration recommendations, the literature is poor in this field.
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The CMS (Brest Metropolitan Area Sports Medicine Centre, France) aims at preserving the health of young athletes. Prior to their medical examination, the patients will be asked, all along the year 2024, to fill out a form that question them about their health behaviors in the four areas of the IP.
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Under the direction of the Brest University Hospital, PRICELESS (Invisible Preparation of Middle and High School Students in Sports Institutions) study will try, based on their answers, to estimate the proportion of young athletes who declare adopting the health behaviors recommended in the IP. conditions: Sports Injury conditions: Prevention conditions: Training conditions: Hydration conditions: Nutrition conditions: Sleep conditions: Mental Health conditions: Physical Well-Being studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 1500 type: ESTIMATED measure: The proportion of teenagers who declare adopting the health behaviors recommended in the four areas of the Invisible Preparation. measure: The proportion of girls who declare adopting these behaviors, compared to the proportion in boys. measure: The proportion of Middle School students who declare adopting these behaviors, compared to the proportion in High School students. measure: The proportion of young athletes practicing an intensive sporting activity (10 hours or more per week), compared to the proportion in young athletes practicing a non-intensive sporting activity (less than 10 hours per week). measure: The proportion of young athletes with disabilities who declare adopting these behaviors, compared to the proportion in young athletes without disabilities. sex: ALL minimumAge: 9 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Chu Brest status: RECRUITING city: Brest zip: 29609 country: France name: Marie-Agnès GIROUX-METGES, PhD role: CONTACT phone: 0298347366 phoneExt: +33 email: marie-agnes.metges@chu-brest.fr name: Florent GUIMARD, Resident role: CONTACT phone: 02 98 33 53 40 phoneExt: +33 email: florent.guimard@chu-brest.fr lat: 48.3903 lon: -4.48628 hasResults: False
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<|newrecord|> nctId: NCT06361758 id: B2023-326(2) briefTitle: Second-line Treatment With CAdonilimab and LEnvatinib for Unresectable HCC overallStatus: NOT_YET_RECRUITING date: 2024-05-31 date: 2026-05-31 date: 2027-05-31 date: 2024-04-12 date: 2024-04-16 name: Shanghai Zhongshan Hospital class: OTHER name: Sun Yat-sen University name: Eastern Hepatobiliary Surgery Hospital briefSummary: This is an open-label, multi-center, single-arm, phase II study to evaluate the efficacy and safety of lenvatinib in combination with cadonilimab as second-line therapy in subjects with advanced hepatocellular carcinoma (HCC) who failed first-line standard therapy of immunotheray and antiangiogenic therapy. conditions: Hepatocellular Carcinoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Cadonilimab+Lenvatinib measure: Objective Response Rate (ORR) per RECIST v1.1 measure: Objective Response Rate (ORR) per mRECIST measure: Disease control Rate (DCR) measure: Duration of response (DoR) measure: Progression-Free-Survival (PFS) measure: Overall survival Overall survival (OS) measure: Incidence of Adverse Events sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Zhongshan Hospital, Fudan University city: Shanghai state: Shanghai zip: 200032 country: China lat: 31.22222 lon: 121.45806 facility: Sun Yat-sen University Cancer Center) city: Guangzhou country: China name: Li Xu role: CONTACT name: Li Xu role: PRINCIPAL_INVESTIGATOR lat: 23.11667 lon: 113.25 facility: Eastern Hepatobiliary Surgery Hospital city: Shanghai country: China name: Kui Wang role: CONTACT name: Jun Xue role: CONTACT name: Kui Wang role: PRINCIPAL_INVESTIGATOR lat: 31.22222 lon: 121.45806 hasResults: False
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<|newrecord|> nctId: NCT06361745 id: PG-005-6 briefTitle: Early Clinical Study of UTAA09 Injection in the Treatment of Relapsed/Refractory Autoimmune Diseases overallStatus: RECRUITING date: 2024-04-02 date: 2024-12-01 date: 2025-03-01 date: 2024-04-12 date: 2024-04-15 name: PersonGen BioTherapeutics (Suzhou) Co., Ltd. class: INDUSTRY briefSummary: Main purpose:
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To evaluate the safety of UTAA09 injection in the treatment of relapsed/refractory (R/R) autoimmune disease (AID).
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Secondary purpose:
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To evaluate the pharmacokinetic (PK) profile of UTAA09 injection in patients with R/R AID.
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To evaluate the pharmacodynamic (PD) characteristics of UTAA09 injection in patients with R/R AID.
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To evaluate the initial efficacy of UTAA09 injection in the treatment of R/R AID subjects.
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To evaluate the immunogenicity of UTAA09 injection in R/R AID subjects. conditions: Systemic Lupus Erythematosus conditions: Idiopathic Inflammatory Myopathies conditions: Systemic Sclerosis conditions: IgG4 Related Disease conditions: Primary Sjögren Syndrome studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: UTAA09 injection primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: T cell injection targeting CD19 chimeric antigen receptor measure: AE measure: Cmax measure: CD19-positive cells measure: Disease remission/response/improvement rates measure: anti-CAR antibody sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: PersonGen.Anke Cellular Therapeutice Co., Ltd status: RECRUITING city: Hefei country: China name: Huimin Meng, Doctor role: CONTACT phone: +86-18015580390 email: huimin.meng@persongen.com lat: 31.86389 lon: 117.28083 hasResults: False
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<|newrecord|> nctId: NCT06361732 id: ILBS-liver Transplant-03 briefTitle: Prevalence of CYP3A5 Polymorphisms in the Donors and ABCB1 Polymorphisms in the Recipients Undergoing Pediatric Liver Transplant and Their Influence on Tacrolimus Levels and Graft Function. overallStatus: RECRUITING date: 2022-12-17 date: 2024-10-30 date: 2024-10-30 date: 2024-04-12 date: 2024-04-12 name: Institute of Liver and Biliary Sciences, India class: OTHER briefSummary: It is known that Immunosuppression post-Liver transplant is central to achieving optimal outcomes in liver transplant recipients. It is required to maintain an adequate balance between reducing rejection and toxicities. Mainstay drugs for maintenance therapy are Calcinuerin inhibitors - Tacrolimus versus cyclosporine. Tacrolimus is preferred, as it has less rejection and better graft survival. However, there is risk of renal and metabolic toxicities. Tacrolimus is bound mainly to alpha1-acid-glycoprotein (encoded by the ABCB1gene) expressed on various epithelial and endothelial cells and lymphocytes. Elimination occurs by metabolizing enzymes of cytochrome P450 system, with biliary excretion (95%) of metabolites (majority) with minority through urine (2.4%). Demethylation and hydroxylation of tacrolimus occurs by hepatic and intestinal CYP3A isoforms (CYP3A4 and CYP3A5). Among the factors that play an important role in the pharmacokinetics of tacrolimus, thus affecting the tacrolimus trough levels in the body and in turn influencing the dosing of the drug required to maintain an adequate balance between reducing rejection and toxicities, genetics plays an important role. Increased expression of CYP3A5 causes more metabolism of tacrolimus and hence affecting the tacrolimus concentration/weight-adjusted dose (C/W-D) ratio in the body. The wild type (CYP3A5\*3) are slow metabolizers and mutant ones (CYP3A5 \*1/\*1 and CYP3A5 \*1/\*3) are fast metabolizers. Fast
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metabolizers have a low C/W-D ratio and require higher Tacrolimus dosing and are thus susceptible to renal and metabolic toxicities, EBV viremia and post transplant lymphoproliferative disorder. Polymorphisms in ABCB1 (c.3435C\>T) are also known to influence tacrolimus dosage in the first week of transplant (C/D ratio was lower in ABCB1 3435CC in comparison to CT and TT). There is no such data in pediatric liver transplant setting from Indian subcontinent. The aim of the study is to study the prevalence of CYP3A5 polymorphisms in the donors and ABCB1 polymorphisms in the recipients undergoing Paediatric liver transplant and their influence on Tacrolimus levels and graft function. conditions: Pediatric Liver Transplant studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: OTHER count: 80 type: ESTIMATED name: No intervention measure: Time (in days) to achieve transaminases within 1.5 times ULN (60 IU/L) in the pediatric Liver transplant recipients with grafts from slow metabolizer (CYP3A5*3/3 allele) versus fast metabolizer (CYP3A5*1/3 and 1/1 alleles) donors. measure: Prevalence of CYP3A5 alleles in the donors of pediatric liver transplant recipients. measure: Influence of donor CYP3A5 alleles (slow versus fast metabolizers) on tacrolimus concentration-weight adjusted dose ratio at 1 week, 4 weeks, 3 months & 6 months and 1 year after liver transplantation. measure: Prevalence of ABCB1 3435 C/T alleles in the recipients of pediatric liver transplant. measure: Influence of recipient ABCB1 3435 C/T on tacrolimus concentration-weight adjusted dose ratio at 1 week, 4 weeks, 3 months and 6 months and 1 year after liver transplantation. measure: Comparison of the Number of Rejection episodes 1 year from LT. measure: Comparison of proportion of patients who were withdrawn from Mycophenolate or required addition of Mycophenolate 1 year from LT. measure: Comparison of proportion of patients with renal toxicity 1 year from LT. measure: Comparison of proportion of patients with Neurological toxicity 1 year from LT. measure: Comparison of e-GFRand cystatin-C levels in the two cohorts of pediatric liver transplant recipients with grafts from slow metabolizer (CYP3A5*3/3 allele) versus fast metabolizer (CYP3A5*1/3 and 1/1 alleles) donors. sex: ALL maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Institute of Liver and Biliary Sciences status: RECRUITING city: New Delhi zip: 110070 country: India name: Dr Snigdha Verma, MD role: CONTACT phone: 01146300000 email: dr.snigdha1@gmail.com name: Dr Rajeev Khanna, MD role: CONTACT phone: 01146300000 email: drrajeev_khanna@rediffmail.com lat: 28.63576 lon: 77.22445 hasResults: False
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<|newrecord|> nctId: NCT06361719 id: 2312INF briefTitle: Efficacy of Two HMOs in Chinese Infants overallStatus: NOT_YET_RECRUITING date: 2024-05-31 date: 2026-11 date: 2027-06 date: 2024-04-12 date: 2024-04-12 name: Société des Produits Nestlé (SPN) class: INDUSTRY briefSummary: This is a randomized, controlled, double-blind, intervention trial of healthy male and female term infants to evaluate the efficacy of the 2 HMOs on beneficially modulating the gut microbiota, gut maturation, gut barrier integrity, immune response, and other developmental outcomes in healthy Chinese infants. The trial consists of 2 randomized formula-fed groups, and a non-randomized breastfed reference group. conditions: Healthy Infants studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 262 type: ESTIMATED name: Experimental Group (EG) name: Control Group (CG) measure: Bifidobacteria abundance in fecal samples measure: Gut microbiota composition measure: Fecal metabolism measure: Fecal metabolism measure: Fecal markers of intestinal immune health measure: Fecal markers of gut barrier function measure: Fecal markers of gut barrier function measure: Fecal markers of gut barrier function measure: Fecal markers of inflammation measure: Fecal markers of inflammation measure: Fecal markers of inflammation measure: Stool patterns measure: Stool patterns measure: GI symptoms and behaviors measure: Immune competence measure: Infant sleep duration and night-time wakings per 24 hours measure: Infant Health Related Quality of Life measure: Growth measure: Growth measure: Growth measure: Growth measure: Growth measure: Physical Examination measure: Infant Illness measure: Infant illness, infections and medication usage measure: Medication use (type and duration) measure: Formula feeding measure: Breastfeeding measure: Infant dietary pattern sex: ALL minimumAge: 3 Days maximumAge: 14 Days stdAges: CHILD hasResults: False
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<|newrecord|> nctId: NCT06361706 id: 24/047-P briefTitle: VR-Enhanced Psychoeducation for Chronic Pain: A Primary Care Pilot Study acronym: REDOCVR overallStatus: RECRUITING date: 2023-12-04 date: 2025-12 date: 2025-12 date: 2024-04-12 date: 2024-04-26 name: Badalona Serveis Assistencials class: OTHER name: Department of Health, Generalitat de Catalunya briefSummary: This pilot study aims to evaluate the integration of virtual reality (VR) with a psychoeducational program for individuals experiencing chronic pain and central sensitization. Chronic pain significantly hampers daily life, and the condition of central sensitization intensifies this challenge by making the pain more acute. Our research is grounded in the hypothesis that VR, when used to complement conventional psychoeducational methods, can enhance engagement and understanding of pain management strategies, thus potentially improving patient outcomes.
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Key objectives and related measured variables include:
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Usability and Feasibility: Evaluated through the System Usability Scale (SUS) responses from both participants and healthcare professionals, assessing the ease of use and integration of VR into the psychoeducational program.
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Participant Engagement and Program Adherence: Determined by participants\' satisfaction with the VR system, using Likert scale questionnaires, and tracked through session attendance and program completion rates.
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Impact on Chronic Pain Management and Emotional Well-being: Assessed through changes in the Warwick-Edinburgh Mental Well-being Scale (WEMWBS), and the Hospital Anxiety and Depression Scale (HADS) collected at baseline, post-intervention, and 4-8 weeks follow-up Self-management of Chronic Pain: Monitored through the Central Sensitization Inventory (CSI) and changes in patient functionality and mobility using the EuroQol-5D-5L scale, measured at baseline, post-intervention, and 4-8 weeks follow-up.
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Healthcare Professionals\' Perceptions: Investigated using SUS scores and qualitative feedback on the applicability and benefits of VR in clinical practice for chronic pain management.
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Participants will complete eight 90-minute sessions, engaging with VR to supplement the program\'s content. This approach aims to provide immersive experiences that deepen the understanding and management of chronic pain. Participant feedback on the VR experience, alongside observed changes in pain management and overall well-being, will be critically examined.
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By targeting individuals suffering from chronic pain, this research aims to offer healthcare professionals an innovative tool for enhancing pain management strategies. Integrating VR into psychoeducational content, the study seeks to promote more engaging and effective learning experiences, potentially leading to improved outcomes in chronic pain management. conditions: Chronic Pain conditions: Central Sensitization studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: The REDOCVR study utilizes a Single-Group Interventional Model, where all participants receive the same VR-enhanced psychoeducational intervention for chronic pain management. This model facilitates a focused evaluation of VR's effectiveness and usability within a structured psychoeducational framework, allowing for direct assessment of participant experiences and outcomes. primaryPurpose: SUPPORTIVE_CARE masking: NONE maskingDescription: The statisticians and researchers involved in data analysis will be masked to the identity of participants, using a random code for each participant. count: 60 type: ESTIMATED name: VR-Enhanced Psychoeducational Program for Chronic Pain measure: Participant Satisfaction with the VR-enhanced Psychoeducational Program as measured by the Participants Satisfaction Questionnaire measure: Participants´ System Usability and VR Headset Comfort as assessed by the SUS for participants measure: Professionals System Usability as measured by the SUS for Professionals measure: Mental Well-being as assessed by the WEMWBS-7 measure: Anxiety and Depression Severity as measured by the HADS measure: Central Sensitization as measured by the CSI measure: Changes in Functionality and Mobility as assessed by the EuroQol-5D-5L Scale measure: Adherence to the VR-enhanced Psychoeducational Program as indicated by session attendance and program completion rates measure: Participant Feedback as recorded on the Participant Comment Sheet sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Primary Care Progrès-Raval status: RECRUITING city: Badalona state: Barcelona zip: 08912 country: Spain name: Jose Ferrer Costa, MD role: CONTACT phone: 0034933951779 email: jfcosta@bsa.cat name: Elena Villabona López, MSc role: CONTACT phone: 0034933890695 email: evlopez@bsa.cat name: Elena Villabona Lopez, MSc role: SUB_INVESTIGATOR name: Jose Ferrer Costa, MD role: PRINCIPAL_INVESTIGATOR name: Melanie Rodriguez Belloso, BSc role: SUB_INVESTIGATOR lat: 41.45004 lon: 2.24741 facility: Primary Care Center Apenins-Montigalà status: RECRUITING city: Badalona state: Barcelona zip: 08917 country: Spain name: José Ferrer Costa, MD role: CONTACT phone: 0034933951779 email: jfcosta@bsa.cat name: Christian Torrecillas Camacho, BSc role: CONTACT phone: 0034933951779 email: ctcamacho@bsa.cat name: José Ferrer Costa, MD role: PRINCIPAL_INVESTIGATOR name: Christian Torrecillas Camacho, BSc role: SUB_INVESTIGATOR name: Alexandra Fernandez Brusco, BSc role: SUB_INVESTIGATOR lat: 41.45004 lon: 2.24741 facility: Primary Care Center Morera-Pomar status: RECRUITING city: Badalona state: Barcelona country: Spain name: Nuria Moran Blanco, MD role: CONTACT phone: 0034934655200 email: nmoran15@bsa.cat name: Laura Villares Urgell, MSc role: CONTACT phone: 0034934655200 email: lvurgell@bsa.cat name: Jose Ferrer Costa, MD role: PRINCIPAL_INVESTIGATOR name: Nuria Moran Blanco, MD role: SUB_INVESTIGATOR name: Laura Villare Urgel, MSc role: SUB_INVESTIGATOR lat: 41.45004 lon: 2.24741 hasResults: False
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<|newrecord|> nctId: NCT06361693 id: APHP240147 id: 2024-A00143-44 type: OTHER domain: France : Ministry of Health briefTitle: Descriptive Observational Study of Patient-performed Pre-oxygenation acronym: ApréOx overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2024-11 date: 2024-12 date: 2024-04-12 date: 2024-04-15 name: Assistance Publique - Hôpitaux de Paris class: OTHER briefSummary: The aim of this research would be to determine the efficacy and effects of preoxygenation when performed by the patient (mask held by the patient).
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This is the concept of "self-preoxygenation". conditions: Anesthesia conditions: Anxiety conditions: ASA Physical Status I conditions: ASA Physical Status II studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 110 type: ESTIMATED name: Auto-preoxygenation name: APAIS scale name: Visual analog anxiety scale (VAS-A) name: Visual analog comfort scale (VAS-C) measure: FeO2>90% measure: APAIS anxiety score measure: Visual analog anxiety scale (VAS-A) score measure: Visual analog anxiety scale (VAS-A) score measure: Visual analog comfort scale (VAS-C) score sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Anesthesia-intensive care department - Cochin - Port-Royal hospital - APHP city: Paris state: Ile De France zip: 75014 country: France name: Sophie TOUSSAINT, Nurse anesthetist role: CONTACT phone: 00 33 1 58 41 45 17 email: sophie.toussaint@aphp.fr name: Claude LE STANG, Nurse anesthetist role: CONTACT email: cch.grouperecherche@gmail.com name: Christophe BAILLARD, PUPH role: SUB_INVESTIGATOR lat: 48.85341 lon: 2.3488 hasResults: False
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<|newrecord|> nctId: NCT06361680 id: Coenzyme Q10 on diabetic child briefTitle: Effect of Coenzyme Q10 on Diabetic Children overallStatus: NOT_YET_RECRUITING date: 2024-10-30 date: 2025-10-30 date: 2025-11-30 date: 2024-04-12 date: 2024-04-12 name: Assiut University class: OTHER briefSummary: Determine the effect of Coenzyme Q10 on random blood sugar and glycosylated haemoglobin conditions: Type 1 Diabetes Mellitus studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SCREENING masking: NONE count: 100 type: ESTIMATED name: Coenzyme Q10 Cap/Tab as natural factors capsules or kirkman tablets measure: Assess the effect of Coenzyme Q10 on glycated haemoglobin in type 1 diabetes mellitus measure: Control of random blood sugar and glycated haemoglobin in children with type 1 diabetes mellitus . sex: ALL minimumAge: 2 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT hasResults: False
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<|newrecord|> nctId: NCT06361667 id: 1/02.02.2024 briefTitle: Culture and Well-being: Art as Prescription Therapy ("Art on Prescription") acronym: AoP overallStatus: RECRUITING date: 2024-03-20 date: 2024-12-15 date: 2025-01-15 date: 2024-04-12 date: 2024-04-12 name: KAVADIA ELENI class: OTHER briefSummary: Cluster randomised controlled trial with two arms: arts intervention (any of the arts interventions, see list), which we call here Active Group (AG) vs waitlist control (WL). conditions: Mental Health Issue conditions: Anxiety Disorders conditions: Depressive Disorder conditions: Emotional Disorder conditions: Schizophrenia conditions: Autism studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: We will follow standard practice for RCTs and apply an ANCOVA model to estimate the effects of treatment. The formalism is:
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y \~ b0 + b1xtreatment_group + b2xtime + b3xtreatment_groupxtime + covariates (1)
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Where, y is each outcome, b1-b3 are the regression coefficients and covariates denotes covariates at randomisation (DETERMINE)
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The inference of interest for the model concerns b3, the interaction term, as we posit that there will be a difference in slopes between the treatment groups.
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The inference is going to happen via an estimation of the t-statistic, defined as follows"
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t = b3/SE (2)
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Where SE is the standard error for coefficient b3
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t \> 1.96 (3)
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And 1.96 is the critical value for statistical significance at alpha = 0.05. primaryPurpose: TREATMENT masking: NONE count: 384 type: ESTIMATED name: Arts measure: The Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) measure: Generalised Anxiety Disorder Assessment (GAD-7) measure: The Patient Health Questionnaire-9 (PHQ-9) measure: UCLA 3-item Loneliness Scale measure: The Strengths and Difficulties Questionnaire (SDQ) sex: ALL minimumAge: 10 Years maximumAge: 99 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Eleni Kavadia status: RECRUITING city: Athens country: Greece name: Eleni Kavadia role: CONTACT phone: +30 210 6170804 email: ekavadia@epipsi.gr name: Nikos Stefanis, PhD role: PRINCIPAL_INVESTIGATOR lat: 37.97945 lon: 23.71622 typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2024-03-10 uploadDate: 2024-03-26T12:19 filename: Prot_000.pdf size: 390364 hasResults: False
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