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Establish a specialized cohort for sarcopenia through a longitudinal investigation, implementing the digital drug and digital rehabilitation interventions. |
Participants will: |
Engage in screening and assessment based on inclusion and exclusion criteria. |
Be monitored longitudinally, with tailored interventions for those with muscle atrophy and regular follow-ups for at-risk individuals. |
Key outcomes will focus on sarcopenia indicators, serum biomarkers, and clinical endpoints such as fracture rates, weakness classification, and quality of life. conditions: Sarcopenia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 10000 type: ESTIMATED measure: Appendicular skeletal muscle mass index measure: Hand grip strength measure: Gait speed measure: Concentration of insulin measure: Concentration of adiponectin measure: Concentration of leptin measure: Concentration of insulin like growth factor -1(IGF-1) measure: Concentration of interleukin 18 (IL-18) measure: Concentration of tumor necrosis factor - α (TNF-α) measure: Concentration of TNF-like weak inducer of apoptosis (TWEAK) measure: Concentration of fibroblast growth factor -19 (FGF-19) measure: Concentration of myostatin measure: Concentration of chemoattractant protein-1 (MCP-1) measure: Concentration of activin sex: ALL minimumAge: 45 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Peking Union Medical College Hospital status: RECRUITING city: Beijing state: Beijing zip: 100730 country: China name: Kang Yu, MD role: CONTACT phone: +86 010-69155550 email: [email protected] lat: 39.9075 lon: 116.39723 hasResults: False |
<|newrecord|> nctId: NCT06380764 id: RC.11.3.2024 briefTitle: Greater Occipital Nerve Block Value in Management of Postdural Puncture Headache overallStatus: COMPLETED date: 2023-03-02 date: 2023-07-25 date: 2023-12-01 date: 2024-04-24 date: 2024-04-24 name: Benha University class: OTHER briefSummary: Neuraxial techniques are well tolerated and effective options for labor analgesia and anesthesia for caesarean section, and may protect high risk women against severe maternal morbidity. However, neuraxial techniques still have drawbacks especially postdural puncture headache (PDPH) and may be associated with chronic headache, back pain and postnatal depression. PDPH is a relatively common acute complication of neuraxial techniques that was traditionally considered benign and self-limiting, but it significantly impacts patients' general health and quality of life. |
Greater Occipital Nerve (GON) originates from C2-3 segments and through its muscular relations it is divided as proximal and distal parts; the most proximal part lies between obliquus capitis inferior and semispinalis and then passes through the semispinalis to pierce the trapezius muscle. In distal region of trapezius fascia, the GON is crossed by the occipital artery and exits the trapezius fascia into the nuchal line about 5-cm lateral to midline. Functionally, GON provides motor supplies to the muscles while passing through it and its main sensory supply is in the occipital region. conditions: Postdural Puncture Headache studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: SINGLE whoMasked: PARTICIPANT count: 152 type: ACTUAL name: Greater Occipital Nerve Block name: Bilateral suboccipital intramuscular injection name: Epidural Blood Patch name: Normal Saline 10 mL Injection name: Lidocaine 2% Injectable Solution measure: The extent of reduction of consumed analgesia sex: ALL minimumAge: 25 Years maximumAge: 55 Years stdAges: ADULT facility: Benha university city: Banhā state: El Qalyoubia zip: 13511 country: Egypt lat: 30.45906 lon: 31.17858 hasResults: False |
<|newrecord|> nctId: NCT06380751 id: D9722C00001 briefTitle: Saruparib (AZD5305) Plus Camizestrant Compared With CDK4/6 Inhibitor Plus Endocrine Therapy or Plus Camizestrant in HR-Positive, HER2-Negative (IHC 0, 1+, 2+/ ISH Non-amplified), BRCA1, BRCA2, or PALB2m Advanced Breast Cancer acronym: EvoPAR-BR01 overallStatus: NOT_YET_RECRUITING date: 2024-04-18 date: 2029-03-30 date: 2030-07-18 date: 2024-04-24 date: 2024-04-24 name: AstraZeneca class: INDUSTRY briefSummary: The primary objective of the study is to measure efficacy of saruparib (AZD5305) plus camizestrant compared with physician's choice CDK4/6i plus ET in patients with BRCA1, BRCA2, or PALB2m, HR-positive, HER2-negative (defined as IHC 0, 1+, 2+/ ISH non-amplified) advanced breast cancer. conditions: Advanced Breast Cancer studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE maskingDescription: Open label count: 500 type: ESTIMATED name: Saruparib (AZD5305) name: Camizestrant name: Abemaciclib name: Ribociclib name: Palbociclib name: Fulvestrant name: Letrozole name: Anastrozole name: Exemestane measure: Progression-Free Survival measure: Overall Survival measure: Progression Free Survival 2 measure: Time to chemotherapy measure: Objective Response Rate measure: Duration of Response measure: Participant-reported tolerability measure: Time to deterioration in patient-reported global health status/QoL as measured by the global health status/QoL scale within the The European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ) measure: Change from baseline in patient-reported global health status/QoL as measured by the global health status/QoL scale within the The European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ) measure: Plasma concentrations of saruparib (AZD5305) measure: Plasma concentrations of camizestrant measure: Samples will be used to develop companion diagnostics by analyzing their performance characteristics and calculate their consistency with clinical trial assays used for enrolment onto the study. sex: ALL minimumAge: 18 Years maximumAge: 130 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Research Site city: Toronto state: Ontario zip: M5G 2M9 country: Canada lat: 43.70011 lon: -79.4163 facility: Research Site city: Montreal state: Quebec zip: H3T 1E2 country: Canada lat: 45.50884 lon: -73.58781 facility: Research Site city: Montréal state: Quebec zip: H2X 0A9 country: Canada lat: 45.50884 lon: -73.58781 facility: Research Site city: Saskatoon state: Saskatchewan zip: S7N 4H4 country: Canada lat: 52.13238 lon: -106.66892 facility: Research Site city: Toronto zip: M4N 3M5 country: Canada lat: 43.70011 lon: -79.4163 hasResults: False |
<|newrecord|> nctId: NCT06380738 id: D0817R00074 id: D0817R00074 type: OTHER domain: AstraZeneca briefTitle: Real-World Clinical Experience of Patients With Metastatic Castration-Resistant Prostate Cancer Treated With Olaparib + Abiraterone (PROceed) acronym: PROceed overallStatus: RECRUITING date: 2024-02-14 date: 2027-01-31 date: 2027-01-31 date: 2024-04-24 date: 2024-04-24 name: AstraZeneca class: INDUSTRY name: Merck Sharp & Dohme LLC briefSummary: PROceed is a multisite, prospective, observational study that describes the real-world use and clinical experience of mCRPC patients treated with the combination of olaparib and abiraterone in the mCRPC setting. Clinical outcomes will be assessed in patients who are either NHA-naive or NHA-exposed prior to initiating olaparib + abiraterone treatment, respectively. Patient demographic and clinical characteristics, as well as treatment received prior and subsequent to olaparib + abiraterone, will also be described. The study plans to enroll patients for a maximum of 2 years and follow up patients from initiation of olaparib until 1 year post last patient in. conditions: Metastatic Castration-resistant Prostate Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 250 type: ESTIMATED measure: Time to treatment discontinuation measure: Time to first subsequent therapy sex: MALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Research Site status: RECRUITING city: Aschaffenburg country: Germany lat: 49.97704 lon: 9.15214 facility: Research Site status: RECRUITING city: Berlin country: Germany lat: 52.52437 lon: 13.41053 facility: Research Site status: NOT_YET_RECRUITING city: Berlin country: Germany lat: 52.52437 lon: 13.41053 facility: Research Site status: RECRUITING city: Duisburg country: Germany lat: 51.43247 lon: 6.76516 facility: Research Site status: NOT_YET_RECRUITING city: Franckfurt country: Germany facility: Research Site status: RECRUITING city: Halle country: Germany lat: 51.48159 lon: 11.97948 facility: Research Site status: RECRUITING city: Herzogenaurach country: Germany lat: 49.56798 lon: 10.88565 facility: Research Site status: NOT_YET_RECRUITING city: Leipzig country: Germany lat: 51.33962 lon: 12.37129 facility: Research Site status: NOT_YET_RECRUITING city: Lueneburg country: Germany lat: 53.2509 lon: 10.41409 facility: Research Site status: RECRUITING city: Muhlheim country: Germany lat: 50.11667 lon: 8.83333 facility: Research Site status: RECRUITING city: Nurnberg country: Germany lat: 49.45421 lon: 11.07752 facility: Research Site status: RECRUITING city: Russelsheim country: Germany lat: 49.98955 lon: 8.42251 facility: Research Site status: RECRUITING city: Speyer country: Germany lat: 49.32083 lon: 8.43111 facility: Research Site status: RECRUITING city: Wetzlar country: Germany lat: 50.56109 lon: 8.50495 hasResults: False |
<|newrecord|> nctId: NCT06380725 id: jshim8zay6vd briefTitle: The Treatment of High Intensity Transcranial Current Stimulation for Alzheimer's Disease overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-08 date: 2024-12 date: 2024-04-24 date: 2024-04-24 name: Anhui Provincial Hospital class: OTHER_GOV briefSummary: Alzheimer's disease (AD) is a neurodegenerative disorder characterized by progressive cognitive dysfunction and behavioral impairment. It is currently the most common type of dementia in the old age. At present, the clinical treatment of Alzheimer's disease is expensive and has side effects, so it is very important to explore new methods of treatment for AD. Investigators designed a prospective, randomized, double-blinded and placebo-controlled trial to investigate the effect of transcranial alternating current stimulation (tACS) on cognitive function in AD patients and to assess the biological effectiveness of the treatment. conditions: Alzheimer's Disease conditions: Mild Cognitive Impairment conditions: Dementia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Investigators designed a randomized double-blinded placebo-controlled trial by randomly dividing subjects into two groups: one is the treatment group and the other is the placebo group. primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: Investigators designed a double-blinded trial in which neither the investigator nor the subjects know whether they will be received the treatment or a placebo. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 60 type: ESTIMATED name: Transcranial alternating current stimulation(real stimulation) name: Transcranial alternating current stimulation(sham stimulation) measure: Cognitive appraisal measure: Global Cognitive appraisal measure: Psychobehavioral assessment measure: Near-infrared spectroscopy measure: Event related potential measurement measure: Peripheral blood biomarkers measure: Magnetic Resonance Imaging measure: Incidence of side effects sex: ALL minimumAge: 45 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06380712 id: 6509 briefTitle: HYPERTESSA "HyperTessa User Experience Study (HTUX)" overallStatus: NOT_YET_RECRUITING date: 2024-05-02 date: 2024-09-30 date: 2024-10-31 date: 2024-04-24 date: 2024-04-24 name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS class: OTHER briefSummary: Background: Hypertension is the primary cause of cardiovascular diseases and premature death in the world. Hypertension management starts with the control of blood pressure, whatever it is the type and severity. The optimum control of blood pressure requires regular and frequent auto-monitoring of blood pressure values, adherence to medication plan, and modification of lifestyle behaviours, including diet, quit smoking, and physical activity. This study is a pilot project to assess acceptance ad usability of a digital health solution to be used by patients diagnosed with hypertension. Materials and methods: Prior to the development of the solution, a literature research was performed, then focus group meetings were conducted with senior experts in the digital field, physicians treating hypertension, and patients. A mobile app and web platform were created to help patients in monitoring and reporting data about health status and lifestyle. In order to execute the study, first the physicians in charge of the study will register in the webApp, creating a personal account. Then, patients who meet the inclusion criteria are proposed to participate to the study and, in case of agreement, will be asked to sign the informed consent (IC) statement and the privacy policy. After the phase of profile setting and onboarding, the patient will start to use the mobile App for hypertension management. Once the patient has used the App for the observation period, the physician will be allowed to analyze the data to understand the level of acceptance and regular usage from each patient. This physician will perform this analysis using a web-based portal which is part of the digital solution. Results: During the study, data about usage patterns will be collected. Specific data about usability and acceptance will be gathered through the use of User Experience Questionnaire (UEQ) and unstructured interviews and tests. After each patient has completed the observation period, all the data will be analysed using mainly descriptive statistics to obtain metrics related to usage patterns, usability and adherence. The study results from this pilot phase will be used to modify the digital solution, leveraging an incremental, iterative logic following a co-design and agile methodology. After incorporating the feedback from this pilot and further enriching the solution, next phases of the study are forseen in order to assess the care benefit of such technology in terms of improved treatment outcomes, due to better adherence, higher motivation in practicing healthy lifestyle, better information, and personalized support from HCP. conditions: Hypertension studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 30 type: ESTIMATED measure: User Experience / User Acceptance Indicators for patients measure: User Experience / User Acceptance Indicators for Healthcare Professionals sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fondazione Policlinico Universitario A. Gemelli., IRCCS city: Rome country: Italy name: Andrea Flex, MD, PhD role: CONTACT phone: + 39 06 3015 4293 email: [email protected] lat: 41.89193 lon: 12.51133 hasResults: False |
<|newrecord|> nctId: NCT06380699 id: HJG-CZQH-QHRD106-I briefTitle: Study to Assess PK, Safety and Tolerability in Healthy Subjects overallStatus: COMPLETED date: 2023-03-16 date: 2023-11-16 date: 2023-12-25 date: 2024-04-24 date: 2024-04-26 name: Changzhou Qianhong Bio-pharma Co., Ltd. class: INDUSTRY briefSummary: The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of QHRD106 in Chinese healthy subjects with single and multiple doses. conditions: Acute Ischemic Stroke studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 56 type: ACTUAL name: QHRD106 Injection name: Yurekline name: placebo measure: Safety as assessed by incidence, severity, and causality of adverse events measure: Plasma measurements of QHRD106 measure: Concentration of bradykinin in plasma sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Nanjing Drum Tower Hospital city: Nanjing state: Jiangsu zip: 210008 country: China lat: 32.06167 lon: 118.77778 hasResults: False |
<|newrecord|> nctId: NCT06380686 id: AIO-KHT-0322/ass briefTitle: Head and Neck Carcinoma Clinical Research Platform for Molecular and Blood-based Biomarkers, Treatment and Outcome acronym: HEAT overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2029-05 date: 2030-05 date: 2024-04-24 date: 2024-04-24 name: AIO-Studien-gGmbH class: OTHER name: Merck Sharp & Dohme LLC briefSummary: Prospective, open, non-interventional, multi-center clinical registry study with the aim to establish a comprehensive research platform reflecting the real-world treatment landscape for recurrent/metastatic head and neck tumor patients. conditions: Squamous Cell Carcinoma of the Oral Cavity conditions: Squamous Cell Carcinoma of the Oropharynx conditions: Squamous Cell Carcinoma of the Hypopharynx conditions: Squamous Cell Carcinoma of the Larynx studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 120 type: ESTIMATED name: data collection measure: Sociodemographic factors measure: Treatments measure: Response rates measure: Treatment decision measure: Progression-free survival measure: Time-to-treatment-failure measure: Overall survival sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Universitätsklinikum Essen city: Essen zip: 45147 country: Germany name: Victor Grünwald, Prof. Dr. role: CONTACT phone: +49 201 723 85584 email: [email protected] lat: 51.45657 lon: 7.01228 hasResults: False |
<|newrecord|> nctId: NCT06380673 id: s68299 briefTitle: Stepwise Heat-Denaturated Protein Introduction for Tolerance Induction in Food Allergy acronym: TEHITI overallStatus: RECRUITING date: 2024-04-22 date: 2028-12-30 date: 2029-12-30 date: 2024-04-24 date: 2024-04-24 name: Universitaire Ziekenhuizen KU Leuven class: OTHER briefSummary: This interventional study aims to validate an early heated protein introduction protocol in cow's milk allergic children who already developed tolerance towards extensively heated cow's milk, in order to speed up the development of complete cow's milk tolerance. Natural complete tolerance induction towards cow's milk takes several years of strict cow's milk avoidance with high risk of anaphylaxis by accidental cow's milk intake. By shortening the time towards complete tolerance, not only the quality of life of both children and parents ameliorates drastically, the time frame for potential anaphylactic reactions is also strongly reduced and can be considered as a preventive strategy to reduce allergic reactions too. Moreover, this strategy has proved efficient for hen's egg allergy. The main question this study wants to answer is whether a 12 months stepwise heated cow's milk introduction (either by gradual reduction of the cooking time or by the use of the Flemish Milk Ladder) in 20'-cooked cow's milk tolerant subjects, results in a larger proportion of complete cow's milk tolerant children after 12 months compared to natural tolerance induction (with 20' cooked milk introduction only). conditions: Food Allergy conditions: Cow Milk Allergy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: NONE count: 90 type: ESTIMATED name: Implementation of cow's milk in decreasingly heated forms name: Implementation of heated cow's milk name: No intervention measure: Complete cow's milk tolerance after 12 months of stepwise heated cow's milk introduction measure: Time to complete tolerance in all three arms measure: Quality of life in all three arms measure: Clinical reactions measure: Side effects measure: IL-10-producing cow's milk specific regulatory T and B cells measure: BATs to mimic the outcome of cow's milk provocation tests sex: ALL minimumAge: 1 Year maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Imelda Hospital Bonheiden status: RECRUITING city: Bonheiden country: Belgium name: Katrien Coppens, MD role: CONTACT lat: 51.02261 lon: 4.54714 facility: AZ Sint-Jan status: RECRUITING city: Brugge country: Belgium name: Kate Sauer, MD role: CONTACT lat: 51.20892 lon: 3.22424 facility: AZ Maria Middelares status: RECRUITING city: Ghent country: Belgium name: Jasmine Leus, MD role: CONTACT lat: 51.05 lon: 3.71667 facility: Jessa Hospital status: RECRUITING city: Hasselt country: Belgium name: Sophie Verelst, MD role: CONTACT lat: 50.93106 lon: 5.33781 facility: UZ Leuven Gasthuisberg status: RECRUITING city: Leuven country: Belgium name: Dominique MA Bullens, Prof. Dr. role: CONTACT phone: +32016343801 email: [email protected] lat: 50.87959 lon: 4.70093 hasResults: False |
<|newrecord|> nctId: NCT06380660 id: ACE-106-001 briefTitle: Study of ACE-86225106 to Treat Patients With Advanced Solid Tumors overallStatus: RECRUITING date: 2024-03-22 date: 2028-12-21 date: 2029-03-21 date: 2024-04-24 date: 2024-04-24 name: Acerand Therapeutics (Shanghai) Limited class: INDUSTRY briefSummary: The purpose of this study is to determine if the experimental treatment with poly-ADP ribose polymerase (PARP) inhibitor, ACE-86225106 is safe, tolerable and has anti-cancer activity in adult patients with advanced solid tumors. conditions: Solid Tumor, Adult conditions: BRCA1 Mutation conditions: BRCA2 Mutation conditions: Ovarian Cancer conditions: Breast Cancer conditions: Prostate Cancer studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 298 type: ESTIMATED name: ACE-86225106 tablet measure: Number of participants experiencing adverse events (AEs)/serious adverse events (SAEs) measure: The number of patients experiencing dose limiting toxicity (DLT), as defined in the protocol measure: Recommended Phase 2 dose (RP2D) and/or maximum tolerated dose (MTD) measure: Objective Response Rate (ORR) measure: Duration of Response (DoR) and Time to Response (TTR) measure: Progression Free Survival (PFS) measure: Overall Survival (OS) measure: Pharmacokinetic (PK) parameters and Pharmacodynamic (PD) marker change measure: Serum tumor marker change: CA125, etc. (OC), prostatic specific antigen (PSA, prostate cancer) decreased, and specific tumor markers for other tumor types may also be included (to be assessed by clinical investigators) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fujian Cancer Hospital status: RECRUITING city: Fuzhou state: Fujian country: China lat: 26.06139 lon: 119.30611 facility: Sun Yat-Sen University Cancer Center status: NOT_YET_RECRUITING city: Guangzhou state: Guangdong country: China lat: 23.11667 lon: 113.25 facility: Hubei Cancer Hospital status: RECRUITING city: Wuhan state: Hubei country: China lat: 30.58333 lon: 114.26667 facility: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology status: NOT_YET_RECRUITING city: Wuhan state: Hubei country: China lat: 30.58333 lon: 114.26667 facility: Hunan Cancer Hospital status: RECRUITING city: Changsha state: Hunan country: China lat: 28.19874 lon: 112.97087 facility: Fudan University Shanghai Cancer Center status: RECRUITING city: Shanghai state: Shanghai country: China lat: 31.22222 lon: 121.45806 facility: Zhejiang Cancer Hospital status: RECRUITING city: Hangzhou state: Zhejiang country: China lat: 30.29365 lon: 120.16142 hasResults: False |
<|newrecord|> nctId: NCT06380647 id: 0004 briefTitle: Comparison of Prophylactic Acyclovir and Placebo in Prevention of Eczema Herpeticum in Pediatric Burns acronym: childburn overallStatus: COMPLETED date: 2019-10-01 date: 2020-09-30 date: 2020-09-30 date: 2024-04-24 date: 2024-04-24 name: King Edward Medical University class: OTHER briefSummary: Introduction: Early detection is important in treating patients with Eczema Herpeticum (EH), which may arise in paediatric burn patients. As soon as a clinical diagnosis is confirmed, antiviral medications should be started to ensure an early resolution of the disease. Several studies have indicated that acyclovir is the best treatment for EH lesions in the majority of individuals. |
Objective: Compare efficacy of the prophylactic acyclovir and placebo in preventing eczema Herpeticum in paediatric burn patients conditions: Herpes Virus Infection studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Sample size of 64 patients (32 patients in each group) was estimated by using 5% level of significance, 90% power of test with expected percentage of patients given prophylactic acyclovir as 81.3% and patients given placebo as 42.9%. primaryPurpose: PREVENTION masking: SINGLE maskingDescription: parents were blinded to group allocation whoMasked: PARTICIPANT count: 64 type: ACTUAL name: Intravenous Acyclovir measure: Number of participants with positive Tzanck smear sex: ALL minimumAge: 1 Month maximumAge: 13 Years stdAges: CHILD facility: department of pediatric surgery King Edward Medical University city: Lahore state: Punjab zip: 54000 country: Pakistan lat: 31.558 lon: 74.35071 hasResults: False |
<|newrecord|> nctId: NCT06380634 id: NYalcinbas briefTitle: The Effectiveness of Motivational Interviewing in Reducing the Use of Household Chemicals and Personal Care Products During Pregnancy overallStatus: COMPLETED date: 2023-01-23 date: 2023-12-31 date: 2024-02-20 date: 2024-04-24 date: 2024-04-24 name: Istanbul University - Cerrahpasa (IUC) class: OTHER briefSummary: Objective: The aim of the study is to examine the effect of motivational interviewing on reducing the use of household chemicals and personal care products during pregnancy. conditions: Motivational Interview conditions: Cosmetic Product Causing Toxic Effect studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: The research was conducted in a prospective pre-test, post-test based randomized controlled experimental research design. primaryPurpose: SCREENING masking: NONE maskingDescription: The groups were randomized into 2 groups using a web-based randomization program (http://www.randomizer.org). The researcher included pregnant women who met the inclusion criteria in the outpatient clinics on certain days of the week, in accordance with the randomization process. count: 130 type: ACTUAL name: Experimental group- Motivational Interview measure: Evaluation Form for Use of Domestic Chemicals and Personal Care Products measure: Self Efficacy Competence Scale measure: Endocrine Disruptors Attitude Scale sex: FEMALE minimumAge: 20 Years maximumAge: 43 Years stdAges: ADULT facility: Istanbul University Cerrahpasa city: Istanbul country: Turkey lat: 41.01384 lon: 28.94966 typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2024-02-05 uploadDate: 2024-04-17T16:09 filename: Prot_000.pdf size: 142041 typeAbbrev: SAP hasProtocol: False hasSap: True hasIcf: False label: Statistical Analysis Plan date: 2024-02-05 uploadDate: 2024-04-17T16:13 filename: SAP_001.pdf size: 234444 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2023-12-30 uploadDate: 2024-04-17T16:05 filename: ICF_002.pdf size: 75804 hasResults: False |
<|newrecord|> nctId: NCT06380621 id: IRC/1386/018 briefTitle: Bilateral vs Unilateral Totally Extraperitoneal Repair Among Patients With Unilateral Inguinal Hernia overallStatus: COMPLETED date: 2018-03-15 date: 2019-02-15 date: 2019-03-15 date: 2024-04-24 date: 2024-04-24 name: B.P. Koirala Institute of Health Sciences class: OTHER briefSummary: The goal of this clinical trial is to investigate the feasibility of bilateral laparoscopic exploration for all unilateral cases followed by laparoscopic bilateral TEP repair in all cases with a contralateral occult hernia and to compare complications, recurrence rates, postoperative pain, and operative duration with prospectively performed unilateral repairs in young to middle-aged patients presenting with unilateral hernias in the surgery outpatient department. |
The main questions it aims to answer are: |
* To compare complications, recurrence rates, postoperative pain, and operative duration between both groups. |
* Incidence of occult contralateral hernia Patients attending the OPD for unilateral inguinal hernia were counseled about the trial and fully encouraged to understand the difference between two procedures for unilateral hernia: bilateral exploration and bilateral TEP repair, upon which if a contralateral occult inguinal hernia was observed, documented, and controls were taken from the patients who denied bilateral exploration and underwent unilateral TEP repair. The allotment of patients was done in two groups of 30 patients each. |
Researchers will compare Group A( bilateral TEP) with Group B (unilateral TEP) to see if complications, recurrence rates, postoperative pain, and operative duration occur in each group conditions: Inguinal Hernia studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 60 type: ACTUAL name: Totally Extra Peritoneal repair (TEP) repair measure: To compare pain in between patients of bilateral totally extra peritoneal repair and unilateral totally extra peritoneal repair. measure: To measure incidence of intra- and post-operative complication between patients of unilateral and bilateral TEP repair sex: ALL minimumAge: 16 Years maximumAge: 55 Years stdAges: CHILD stdAges: ADULT facility: Bikash Kumar Sah city: Dharān Bāzār state: Koshi zip: 56700 country: Nepal lat: 26.81248 lon: 87.28355 typeAbbrev: Prot_ICF hasProtocol: True hasSap: False hasIcf: True label: Study Protocol and Informed Consent Form date: 2018-03-15 uploadDate: 2024-04-21T09:41 filename: Prot_ICF_000.pdf size: 450800 hasResults: False |
<|newrecord|> nctId: NCT06380608 id: 0047-23-ASF briefTitle: Levels of Fear, Anxiety and Wound Healing Among Aental Surgery Patients Under Local Versus General Anesthesia overallStatus: RECRUITING date: 2023-09-01 date: 2024-09-30 date: 2024-12-31 date: 2024-04-24 date: 2024-04-24 name: Zoya Haitov Ben Zikri class: OTHER_GOV briefSummary: Tooth extraction is one of the most common procedures in dentistry. Surgical extraction of damaged wisdom teeth involves bone resection and injury to the soft tissue. Dental care often evokes high levels of anxiety.In addition, stress causes poor regulation of endocrine, autocrine and paracrine systems during the three stages of wound healing of the soft oral tissues. Therefore, special considerations are necessary when performing dental surgery on highly stressed patients. One of the options used in the last decade is to perform this procedure under general anesthesia. |
A stress response stimulates the secretion of cortisol hormone. Cortisol levels were found to be significantly higher before dental surgery, while after the operation the hormone level dropped significantly. |
The aim of the study is to assess the level of anxiety/fear and monitor the wound healing process among patients who are about to undergo surgery to remove wisdom teeth or no more than 3 jaw implants under local anesthesia in the dental clinic compared to patients who are about to undergo the same surgery under general anesthesia. conditions: Wisdom Teeth Extraction or Jaw Implant studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 46 type: ESTIMATED name: Local anesthesia name: General anesthesia measure: Fear and anxiety measure: Wound heeling sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Shamir (Asaf Harofe) Medical center status: RECRUITING city: Be'er Ya'aqov zip: 60930 country: Israel name: sara Bar Yehuda, MD role: CONTACT phone: 972528981004 email: [email protected] lat: 31.93864 lon: 34.83749 hasResults: False |
<|newrecord|> nctId: NCT06380595 id: 23 -1533 briefTitle: Complex EVAR in Inflammatory and Infective Abdominal and Thoracoabdominal Aortic Aneurysms acronym: CEVARII overallStatus: ENROLLING_BY_INVITATION date: 2024-02-21 date: 2025-03 date: 2026-03 date: 2024-04-24 date: 2024-04-24 name: CEVARII class: OTHER name: University of Iowa name: University of Colorado, Denver name: University of Trieste name: University of Copenhagen name: University of Colorado, Colorado Springs briefSummary: Complex endovascular aortic repair in inflammatory and infective perivisceral abdominal aortic aneurysms and thoracoabdominal aortic aneurysms (CEVARII) study is a collaborative international effort among vascular surgeons to establish a database on the global experience in the management of INAAs and IAAs. Ethical approval for the study was obtained from the Colorado Multiple Institutional Review Board (COMIRB) under protocol number 23-1533. conditions: Inflammatory Abdominal Aortic Aneurysm conditions: Aneurysm, Infected conditions: Aneurysm, Mycotic conditions: Abdominal Aortic Aneurysm conditions: Thoracoabdominal Aortic Aneurysm studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 220 type: ESTIMATED name: Complex endovascular aortic repair (cEVAR) measure: Primary Graft Patency measure: Bowel Ischemia measure: Presence of aortic aneurysm endoleak after surgery measure: Aneurysm-related mortality (ARM) measure: Conversion to Open Surgical Repair (OSR) measure: Aortic rupture measure: Post-operative infection-related complication (IRC) measure: The duration of preoperative, perioperative, and postoperative duration of anti-microbial or immunosuppressive pharmacologic therapies. measure: Assessment of Adverse Events (AEs) described in the protocol. measure: All Cause Mortality measure: Continued Aortic sac growth. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Colorado Healthcare city: Aurora state: Colorado zip: 80045 country: United States lat: 39.72943 lon: -104.83192 hasResults: False |
<|newrecord|> nctId: NCT06380582 id: NL85595.068.23 briefTitle: Indoor Air Quality, Temperature and Cognitive Performance acronym: AEOLUS overallStatus: NOT_YET_RECRUITING date: 2024-04-25 date: 2024-12-21 date: 2024-12-21 date: 2024-04-24 date: 2024-04-24 name: Maastricht University Medical Center class: OTHER briefSummary: Study design: A cross-over single-blinded treatment design will be used. Participants will undergo 4 different conditions: (1) low air flow and 23°C, (2) low air flow and 35°C, (3) high air flow and 23°C, and (4) high air flow and 35°C. Participants will be blinded to the air quality level; however, it is not possible to blind them to the temperature condition, as they will be able to perceive it as different. |
Study population: The population consists of healthy young and middle-aged adults of both sexes between 18 and 40 years. |
Intervention (if applicable): Each participant undergoes 4 conditions in randomized order. Two conditions consist of poor air quality defined as 3,000 ppm carbon dioxide and 23°C or 35°C temperature, respectively. conditions: Indoor Air Quality, Temperature and Cognitive Performance studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: BASIC_SCIENCE masking: SINGLE whoMasked: PARTICIPANT count: 22 type: ESTIMATED name: Temperature and Airflow combination measure: Cognition measure: Cognition measure: Heart Rate (bpm) measure: Metabolic Rate (ml/kg/min) measure: Blood Pressure (mmHg) measure: Blood samples measure: Saliva samples measure: Breathing rate measure: Temperature (C) measure: Humidity % measure: Carbon dioxide (CO2) concentration (ppm) sex: ALL minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT hasResults: False |
<|newrecord|> nctId: NCT06380569 id: E-1139-21 Community Setting briefTitle: A Strength-Based Intervention to Improve Job Interview Skills in Young Adults in a Community Setting overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-06-01 date: 2025-12-01 date: 2024-04-24 date: 2024-04-24 name: Kessler Foundation class: OTHER briefSummary: We are looking to evaluate how effective a strength-based intervention may be in improving job interview skills in young adults. We are examining the effects of this intervention in young adults who may have difficulty with job interviews, and who may want to improve these skills. conditions: Autism Spectrum Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SINGLE_GROUP interventionModelDescription: Kessler Foundation Strength Identification and Expression (KF-STRIDE®) primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: KF-STRIDE® measure: Mock Job Interview measure: Employment Status measure: Time-to-reach Employment measure: Strength Knowledge and Strengths Use Scale (SKUS) measure: Youth Interview- Self Efficacy and Anxiety measure: Job Search Behavior Scale measure: Work Readiness Scale measure: Global Assessment of Character Strengths (GACS) measure: Rosenberg Self-Esteem Scale (RSES) sex: ALL minimumAge: 14 Years maximumAge: 26 Years stdAges: CHILD stdAges: ADULT hasResults: False |
<|newrecord|> nctId: NCT06380556 id: 25.05.2022/68 briefTitle: The Effect of Mechanical Vibration and ShotBlocker on Pain Levels During Heel Lance in Healthy Term Neonates overallStatus: COMPLETED date: 2022-11-10 date: 2023-01-30 date: 2023-07-13 date: 2024-04-24 date: 2024-04-24 name: Istanbul Medeniyet University class: OTHER briefSummary: This study was conducted to determine the effect of mechanical vibration and ShotBlocker methods on pain level, crying time and procedure time during heel prick blood collection in healthy term infants. conditions: Procedural Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: In the study, participants were assigned to groups by block randomization. Type of delivery (vaginal and cesarean section), gender (male and female) and birth weight (2500-3000 g, 3001-3500 g, 3501 and above) variables were used for block randomization. Blocks were repeated three times in each group and 36 participants were assigned to each. A randomization list with 2 X 2 X 3 X 3 blocks was developed using an online randomization tool. In the study, the group to which the first participant was assigned was determined by a sealed envelope method. primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE maskingDescription: Using the block randomization technique, participants were divided into three groups. A web-based randomization list generation tool was used to assign participants to groups. Control and intervention groups were coded as A, B and C using the sealed envelope method. Randomization information was withheld from the researcher involved in data collection until data was collected. The researcher determines which group each baby is in. The researcher found out during the painful procedure. (investigator blinding). |
Within the scope of the research, parents knew which group the baby was in. However, due to the nature of the sample group, the babies were blind. |
To avoid statistical bias, study groups were coded as A, B and C; statistical blinding was performed (statistician blinding). whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 108 type: ACTUAL name: ShotBlocker name: Mechanical vibration measure: Procedural pain score- Neonatal Infant Pain Scale (NIPS) measure: Crying time measure: Procedure time sex: ALL minimumAge: 38 Weeks maximumAge: 42 Weeks stdAges: CHILD facility: Istanbul Medeniyet University city: Istanbul state: Kadıköy zip: 34720 country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False |
<|newrecord|> nctId: NCT06380543 id: BILINCE briefTitle: ERCP Biliary Cannulation Success Using ESGE Algorithm acronym: BILINCE overallStatus: RECRUITING date: 2019-12-12 date: 2024-10-31 date: 2024-12-31 date: 2024-04-24 date: 2024-04-24 name: IRCCS San Raffaele class: OTHER name: Societa Italiana di Endoscopia Digestiva briefSummary: Papillary cannulation attempts have been shown to be an independent predictor of post-ERCP pancreatitis (PEP) when they are repeated more than 5 times or for 5 minutes or when the pancreatic duct is opacified or cannulated by using guidewire more than 1 time. In order to reduce complications, the 2016 ESGE guideline recommends a precise sequence of alternative cannulation techniques to the primary guidewire approach before exceeding the stated limits. However, there are no published data about the routinary application of this biliary cannulation algorithm. |
The investigators hypothesised that the ESGE algorithm predicts an increased cannulation success. Nevertheless, it's unclear if this benefit is also associated with a decreased risk of complications, mainly post-procedural pancreatitis. conditions: Biliary Tract Diseases studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 800 type: ESTIMATED measure: Success of ERCP biliary cannulation rate measure: ERCP complication rates sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS OSpedale San Raffaele status: RECRUITING city: Milano zip: 20132 country: Italy name: Alberto Mariani, MD role: CONTACT lat: 45.46427 lon: 9.18951 hasResults: False |
<|newrecord|> nctId: NCT06380530 id: SIMULA briefTitle: Advanced Surgical Simulation Processes in the Correction of Skeletal Defects and Deformities acronym: SIMULA overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2028-05 date: 2029-05 date: 2024-04-24 date: 2024-04-24 name: Istituto Ortopedico Rizzoli class: OTHER name: Ospedale Pediatrico Bambino Gesù name: Istituto Giannina Gaslini name: Galeazzi Orthopedic Institute name: Istituto Nazionale Tumori Regina Elena name: Policlinico San Matteo name: Istituto Clinico Humanitas briefSummary: Virtual Surgical Planning (VSP), Computer-Aided Surgical Simulation (CASS) for bone corrections, and the customization of implants and devices through 3D printing, known as Patient-Specific Instruments (PSI) and Graft-Specific Instruments (GSI), are assuming increasingly central roles in orthopedic clinical and surgical practice. |
One area witnessing notable advancement is the treatment of musculoskeletal disorders (MMS) in children, adolescents, and young adults. These disorders involve severe and rare abnormalities in skeletal formation and development across three-dimensional planes, often affecting multiple limbs. Managing such deformities is complex, challenging to standardize, and prone to unpredictable clinical, radiographic, and functional outcomes. |
The application of 3D modeling and printing technologies offers a deeper understanding of deformities and facilitates improved prediction, precision, reproducibility, and safety in surgical interventions. |
The Musculoskeletal Apparatus Network (RAMS Network) centers are equipped with advanced 3D laboratories for surgical simulation and planning, aligned with the overarching goal of improving surgery quality through "in-silico" medicine (ISM) principles. |
At present, numerous complex surgeries involving Virtual Surgical Planning (VSP) and sterilizable 3D-printed Patient-Specific Instruments (PSI) and/or Graft-Specific Instruments (GSI) are being simulated and performed at the Rizzoli Institute. Preliminary data from previous protocols indicate a significant reduction in surgical time with the implementation of VSP and the utilization of PSI and GSI. |
The aim of this study is to enhance the current process of simulating, planning, and designing surgical support tools within 3D Printing Point-of-Care (3D POC) facilities. To achieve this, it is imperative to expand case volumes and systematically organize, categorize, and standardize simulation and planning procedures. conditions: Musculoskeletal Deformity conditions: Musculoskeletal Abnormalities conditions: Musculoskeletal Disorder studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 100 type: ESTIMATED name: Deformity correction measure: Achieved skeletal corrections measure: Achieved skeletal corrections measure: Operating room times measure: Fluoroscopy times measure: Blood loss measure: Intra- and peri-operative complications measure: Suitability of PSIs measure: Suitability of GSIs measure: Suitability of bone graft measure: Clinical-functional outcome measure: Clinical-functional outcome measure: Cost analysis sex: ALL minimumAge: 2 Years maximumAge: 40 Years stdAges: CHILD stdAges: ADULT facility: IRCCS Istituto Ortopedico Rizzoli city: Bologna state: BO zip: 40136 country: Italy name: Grazia Chiara Menozzi role: CONTACT phone: 0516266 phoneExt: 484 email: [email protected] lat: 44.49381 lon: 11.33875 facility: Istituto Clinico Humanitas city: Rozzano state: MI country: Italy lat: 45.38193 lon: 9.1559 facility: Istituto Giannina Gaslini city: Genova country: Italy name: Giorgio Marrè Brunenghi, MD role: CONTACT email: [email protected] lat: 44.40478 lon: 8.94438 facility: Galeazzi Orthopedic Institute city: Milano country: Italy name: Fabio Verdoni, MD role: CONTACT email: [email protected] lat: 45.46427 lon: 9.18951 facility: Policlinico San Matteo city: Pavia country: Italy name: Gianluigi Pasta, MD role: CONTACT lat: 45.19205 lon: 9.15917 facility: Istituto Nazionale Tumori Regina Elena city: Roma country: Italy name: Roberto Biagini, MD role: CONTACT email: [email protected] lat: 41.89193 lon: 12.51133 facility: Ospedale Pediatrico Bambino Gesù city: Roma country: Italy name: Pier Francesco Costici, MD role: CONTACT email: [email protected] lat: 41.89193 lon: 12.51133 hasResults: False |
<|newrecord|> nctId: NCT06380517 id: ATS23 id: 2UG1EY011751 type: NIH link: https://reporter.nih.gov/quickSearch/2UG1EY011751 briefTitle: Dichoptic Treatment for Amblyopia in Children 4 to 7 Years of Age acronym: ATS23 overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-12-01 date: 2027-05-01 date: 2024-04-24 date: 2024-04-24 name: Jaeb Center for Health Research class: OTHER name: National Eye Institute (NEI) name: Pediatric Eye Disease Investigator Group briefSummary: In children 4 to 7 years of age, to determine if treatment with 1 hour per day 6 days per week of watching dichoptic movies/shows wearing the Luminopia headset is non-inferior to treatment with 2 hours of patching per day 7 days per week with respect to change in amblyopic eye distance VA from randomization to 26 weeks. conditions: Amblyopia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 238 type: ESTIMATED name: Luminopia name: Eye Patch measure: Change in amblyopic eye logMAR distance VA between randomization and 26 weeks sex: ALL minimumAge: 4 Years maximumAge: 7 Years stdAges: CHILD typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2024-04-01 uploadDate: 2024-04-18T09:58 filename: Prot_000.pdf size: 715474 typeAbbrev: SAP hasProtocol: False hasSap: True hasIcf: False label: Statistical Analysis Plan date: 2024-04-17 uploadDate: 2024-04-18T15:02 filename: SAP_001.pdf size: 4154847 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2024-04-17 uploadDate: 2024-04-18T09:59 filename: ICF_002.pdf size: 248300 hasResults: False |
<|newrecord|> nctId: NCT06380504 id: RSWITCH-Ethiopia briefTitle: Increasing the Coverage of Severe Acute Malnutrition (SAM) Treatment in Ethiopia acronym: R-SWITCH overallStatus: NOT_YET_RECRUITING date: 2024-04-29 date: 2026-06-30 date: 2027-06-30 date: 2024-04-24 date: 2024-04-24 name: International Food Policy Research Institute class: OTHER name: Ethiopian Public Health Association name: UNICEF briefSummary: The R-SWITCH intervention aims to address the low coverage of treatment for severe wasting (SAM) by leveraging existing community groups to deliver an integrated package focused on prevention, screening, referral, and treatment of SAM. It includes behavior change communication on child nutrition and health, active screening, improved passive screening at health posts, and follow-up of referred cases and those enrolled in outpatient treatment programs (OTP). The primary objectives of the R-SWITCH studies are to assess the intervention's impact on OTP coverage, identify implementation barriers and facilitators, and evaluate its cost-efficiency and cost-effectiveness. conditions: Acute Malnutrition, Severe conditions: Malnutrition, Child conditions: Wasting studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Cluster randomized controlled trial. Unit/cluster of assignment is health post catchment area. Parallel Assignment: baseline-endline design primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE maskingDescription: Evaluator teams will be blinded from intervention allocation count: 1080 type: ESTIMATED name: R-SWITCH integrated intervention package measure: Period prevalence of SAM OTP treatment coverage in children 6-59 months of age measure: Point prevalence of SAM OTP treatment coverage in children 6-59 months of age measure: Period prevalence of SAM OTP treatment coverage in the subgroup of treatment eligible children 6-59 months of age measure: Screening coverage of SAM measure: Screening coverage of severe underweight measure: Platform specific screening coverage of SAM measure: Growth Monitoring Promotion (GMP) consultation attendance measure: AFD group meeting attendance measure: AFD home visit coverage measure: Prevalence of SAM measure: Prevalence of wasting measure: Prevalence of stunting measure: Prevalence of underweight and severe underweight measure: Mean height-for-age Z-score (HAZ) measure: Mean weight-for-height Z-score (WHZ) measure: Mean weight-for-age Z-score (WAZ) measure: Mean mid-upper arm circumference (MUAC) measure: Caregiver's knowledge related to breastfeeding, complementary feeding,child health and hygiene, the condition of severe acute malnutrition, outpatient therapeutic programs, screening of wasting measure: Vaccination coverage measure: Introduction of (semi) solid and soft complementary foods measure: Minimum dietary diversity in infants and young children (6-23 mo) measure: Nr of food groups consumed by infants and young children (6-59 mo) measure: Minimum meal frequency in infants and young children measure: Minimum acceptable diet in infants and young children measure: Continuous breastfeeding 12-23 months measure: Egg and/or flesh food consumption measure: Sweet beverage consumption measure: Zero vegetable or fruit consumption consumption measure: Minimum milk feeding frequency for non-breastfed children measure: Weight-for-length Z-score and MUAC at Severe Acute Malnutrition (SAM) Outpatient Therapeutic Feeding program (OTP) measure: SAM OTP adherence measure: Weight gain rate during SAM OTP measure: SAM OTP outcomes (drop-out, death, transfer, non-response rates) measure: SAM OTP duration sex: ALL minimumAge: 6 Months maximumAge: 5 Years stdAges: CHILD hasResults: False |
<|newrecord|> nctId: NCT06380491 id: REF.2338 id: UNAM-PAPIIT 32-IN216919 type: OTHER domain: Universidad Nacional Autonoma de Mexico (UNAM) briefTitle: Melatonin's Effect on Nighttime Blood Pressure and Sleep in OSA Patients (MEBP-OSA) acronym: MEBP-OSA overallStatus: RECRUITING date: 2023-06-22 date: 2024-11-22 date: 2025-01-22 date: 2024-04-24 date: 2024-04-25 name: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran class: OTHER name: Universidad Nacional Autonoma de Mexico name: Emory University briefSummary: The goal of this clinical trial is to learn if melatonin works to treat comorbid insomnia in adults with OSA and nocturnal non-dipping blood pressure pattern. |
The main question it aims to answer is: |
Does melatonin maintain sleep during night and recover the dipping blood pressure pattern? conditions: Obstructive Sleep Apnea of Adult studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Patients with a non-dipper pattern in blood pressure will randomly enter one of two options: 1) usual medical treatment; 2) treatment with melatonin plus usual care. primaryPurpose: TREATMENT masking: NONE count: 50 type: ESTIMATED name: Melatonin 3 MG Oral Tablet measure: Melatonin at a dose of 3 mg before sleep time, after a period of 30 days changes the time awake after sleep onset (WASO), and recovers the dipper pattern of blood pressure sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: National Institute of Medical Sciences and Nutrition Salvador Zubirán (INCMNSZ) status: RECRUITING city: Mexico City country: Mexico lat: 19.42847 lon: -99.12766 hasResults: False |
<|newrecord|> nctId: NCT06380478 id: CPRO-000012 briefTitle: Safety and Efficacy of the Bi-Aspheric Monofocal IOL overallStatus: RECRUITING date: 2024-03-05 date: 2024-12-05 date: 2024-12-25 date: 2024-04-24 date: 2024-04-24 name: ICARES Medicus, Inc. class: INDUSTRY name: AST Products, Inc. briefSummary: This is an observational, single-center, non-control, open-label post-marketing study. Patients implanted with an aspicio™ Monofocal Intraocular Lens will be scheduled for a follow-up visit at least 3 months after the surgery to undergo a routine basic ophthalmological examination. conditions: Cataract studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: RETROSPECTIVE count: 30 type: ESTIMATED name: aspicio Monofocal IOL measure: CDVA measure: Defocus curve measure: UDVA measure: UIVA measure: CIVA measure: IOL glistening measure: PCO measure: Satisfaction questionnaire measure: AE sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Chang Gung University Hospital status: RECRUITING city: Taoyuan state: Guishan District zip: 333 country: Taiwan name: Lisa Chen role: CONTACT email: [email protected] name: Yih-Shiou Hwang, MD role: PRINCIPAL_INVESTIGATOR lat: 24.95233 lon: 121.20193 hasResults: False |
<|newrecord|> nctId: NCT06380465 id: 23-11-1838 briefTitle: The Effect of Anthocyanin Intake From Purple Sweet Potato in Cerebral Small Vessel Disease overallStatus: NOT_YET_RECRUITING date: 2024-04-22 date: 2025-04-30 date: 2025-04-30 date: 2024-04-24 date: 2024-04-24 name: Indonesia University class: OTHER name: Fakultas Kedokteran Universitas Indonesia name: Universitas Padjadjaran name: Institut Pertanian Bogor name: School of Science and technology, Kwansei Gakuin University briefSummary: Cerebral small vessel disease (CSVD) is a major cause of disability, cognitive impairment, and functional loss in the elderly. CSVD occurs due to damage to arterioles, capillaries, and venules in the brain parenchyma, and can cause clinical and neuroimaging symptoms. CSVD also accounts for up to 25% of all ischemic stroke cases, and making it the second leading cause of death in the world after ischemic heart disease. |
Purple sweet potatoes, scientifically known as Ipomoea batatas (L.) Lam., contains of high anthocyanin specifically peonidin and cyanidin that has antioxidant, anti-inflammatory, and potentially phytoestrogenic activity. These anthocyanins have been linked to a reduced risk of obesity, diabetes, and high cholesterol. They also show potential in improving endothelial function, thereby enhancing blood vessel vasomotor function and potentially reducing the risk of cardiovascular diseases. Anthocyanins and their metabolites can cross the blood-brain barrier and affect signaling pathways, gene expression, and protein function at the molecular level. In addition to their ability to enhance vascular flow, anthocyanins can also help mitigate the risk factors associated with CSVD by counteracting oxidative stress in the body. These findings exploring the potential benefits of anthocyanins for individuals with CSVD by giving purple sweet potatoes extract comparing with placebo. |
The outcomes that will be assessed are vasomotor reactivity measured by Breath Holding Index in Transcranial Doppler, Nitric Oxide, L-Arginine and Adiponectin levels in blood, Cognitive Test and Gait. conditions: Cerebral Small Vessel Diseases studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The participant who meet the inclusion criteria and have signed the consent will be subjected to a baseline assessment followed by randomization into 2 groups/arms consisting of 2 treatments (1 group getting the water extract pf purple sweet potato) and 1 control group that got placebo. primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: The research was conducted using a single-blind approach, where the participants were unaware of the intervention being implemented whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 90 type: ESTIMATED name: The water extract of "Biang" variety purple sweet potato measure: Breath Holding Index measure: Nitric Oxide measure: L-Arginine measure: Adiponectin measure: Cognitive measure: Gait sex: ALL minimumAge: 40 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2023-12-02 uploadDate: 2024-04-18T03:49 filename: ICF_000.pdf size: 332637 hasResults: False |
<|newrecord|> nctId: NCT06380452 id: SKABUP id: 2023-507925-41-00 type: OTHER domain: EU-Trial-Nr. (EMA) briefTitle: Therapy for Scabies With Two Differently Concentrated Permethrin Creams acronym: SKABUP overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2027-07 date: 2028-12 date: 2024-04-23 date: 2024-04-23 name: Infectopharm Arzneimittel GmbH class: INDUSTRY name: Winicker Norimed GmbH briefSummary: The multi-center, prospective, randomized, double-blind phase III clinical trial will primarily investigate the efficacy and safety of treatment of scabies with Permethrin Cream 5% (approved drug InfectoScab 5% Cream) in direct comparison with Permethrin Cream 10%. |
The trial participants will be randomly assigned and blinded to either Permethrin Cream 5% or Permethrin Cream 10%. conditions: Scabies studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The SKABUP study is a prospective, randomized, double-blind, 2-arm superiority study in a group sequential design with recruitment stop and interim analysis after 172 patients. If there is no evidence of superiority in the interim analysis, the study will be continued unchanged up to the planned number of 220 patients and will be terminated and analyzed regularly. primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: double-blind whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 220 type: ESTIMATED name: 5% Permethrin Creme name: 10% Permethrin Creme measure: clinical efficacy (yes/no) measure: effectiveness at Visit 1 measure: frequency of therapy success measure: itching measure: patients with evidence of mites measure: patients with use of antiscabiosa not compliant with the protocol measure: patients with new scabies efflorescences measure: patients with "additional confirmed" treatment failure measure: AEs, SAEs, ADRs, SUAWs sex: ALL minimumAge: 2 Years maximumAge: 85 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06380439 id: 23-10-1763 briefTitle: The Effect of Wrist Ankle Acupuncture on Post-Total Hip Arthroplasty Pain overallStatus: RECRUITING date: 2024-04-23 date: 2024-07 date: 2024-07 date: 2024-04-23 date: 2024-04-29 name: Indonesia University class: OTHER briefSummary: Total hip arthroplasty is one of the most cost-effective orthopedic surgical procedures which can restore hip function and improve the patient's quality of life. However, total hip arthroplasty is significantly associated with postoperative pain. Pain after total hip arthroplasty surgery can adversely affect the patient's early postoperative recovery, postoperative mobility, and hinder rehabilitation. |
Wrist ankle acupuncture (WAA) is a simpler acupuncture technique, using fewer points, shallow needle insertion and lighter stimulation. Wrist-ankle acupuncture as multimodal analgesia after orthopedic surgery is useful for reducing pain and reduce the incidence of post-surgical side effects. The primary aim of this study is to investigate whether wrist ankle acupuncture therapy gives better and results for post total hip arthroplasty pain than sham wrist ankle acupuncture conditions: Pain, Postoperative conditions: Hip Osteoarthritis conditions: Hip Fractures conditions: Hip Injuries studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 32 type: ESTIMATED name: wrist ankle acupuncture measure: Visual Analog Scale measure: recovery rate sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Cipto Mangunkusumo Hospital status: RECRUITING city: Jakarta Pusat state: Jakarta zip: 10430 country: Indonesia name: Cipto Mangunkusumo Hospital role: CONTACT phone: 1 500 135 lat: -6.1818 lon: 106.8223 facility: Fatmawati Hospital status: RECRUITING city: Jakarta zip: 12430 country: Indonesia name: Fatmawati Hospital role: CONTACT phone: 0217501524 lat: -6.21462 lon: 106.84513 facility: Persahabatan Hospital status: RECRUITING city: Jakarta zip: 13230 country: Indonesia name: Persahabatan Hospital role: CONTACT phone: (021) 4891708 lat: -6.21462 lon: 106.84513 hasResults: False |
<|newrecord|> nctId: NCT06380426 id: APHP230441 id: IDRCB : 2023-A02003-42 type: OTHER domain: ANSM briefTitle: Real-life Evaluation of WEGOVY (Semaglutide) Treatment in Adults With Monogenic Obesity (ObGeSema) acronym: ObGeSema overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2027-04-30 date: 2027-11-30 date: 2024-04-23 date: 2024-04-23 name: Assistance Publique - Hôpitaux de Paris class: OTHER briefSummary: Rare genetic forms of obesity, so called monogenic obesity are linked to alteration in energy balance involving hypothalamic pathways. |
More than 60 genes encoding for proteins located in the hypothalamic leptin/melanocortin pathway have been described in the French National Protocol for Diagnostic and Care (PNDS). |
The natural history of monogenic obesity is characterized by an early onset in childhood, with a major increase in weight in adolescence and young adulthood. The worsening of obesity exposes these patients to severe complications. |
Severe obesity and eating disorders have a major impact on the quality of life of the person but also of the family and caregivers. Clinical management is complex and requires comprehensive, specialized and multidisciplinary management. But the usual lifestyle approaches have so far shown disappointing results, similarly to bariatric surgery which leads to a more frequent weight regain in the situation of monogenic obesity, justifying new approaches. |
In this context, evaluating the response to treatment in the particular condition of monogenic obesity is crucial to propose therapeutic options as early as possible to limit weight evolution and its complications. |
GLP-1 (glucagon-like peptide 1) based innovative therapies have recently emerged as a promising option for treatment of obesity and its complications. This is the case for Semaglutide 2.4mg/week (WEGOVY®), developed by Novo Nordisk. However, there is a lack of data to confirm that semaglutide could be also effective in monogenic obesity. |
The hypothesis in this study is that treatment with Semaglutide 2.4mg/week (WEGOVY®) could be as effective in monogenic obesities as in common obesity. conditions: Monogenic Obesity studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 175 type: ESTIMATED measure: Change in weight and Body Mass Index (BMI) measure: Change in weight and Body Mass Index (BMI) measure: Reduction of body weight equal to or above 5% measure: Change in Hunger score measure: Change in eating behaviour measured by Food Craving questionnaire measure: Change in eating behaviour measured by the Binge Eating Scale (BES) measure: Change in eating behaviour measured by the Dutch Eating Behaviour Questionnaire (DEBQ) measure: Change in eating behaviour measured by the Dykens questionnaire measure: Change in eating behaviour measured by the Child Eating Behaviour Questionnaire (CEBQ) measure: Change in the International physical activity questionnaire (IPAQ - short form) measure: Change in Digestive disorders (GIQLI ) measure: Change in sleep disorder (MCTQ score) measure: Change in score of quality of life scores (patient and parents) measure: Change in anxiety and depression score measure: Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Centre de référence Syndrome de Prader-Willi et autres obésités avec troubles du comportement alimentaire (PRADORT). Service de Nutrition, GH Pitié-Salpêtrière, APHP city: Paris zip: 75013 country: France name: Emilie GUILLON role: CONTACT email: [email protected] name: Sarra POCHON role: CONTACT phone: +33(1)42167574 email: [email protected] lat: 48.85341 lon: 2.3488 hasResults: False |
<|newrecord|> nctId: NCT06380413 id: 78972024.7.0000.5313 briefTitle: Tai Chi Chuan Combined With Walking on Physical and Mental Parameters of Older Adults overallStatus: NOT_YET_RECRUITING date: 2024-05-20 date: 2024-12-31 date: 2025-07-31 date: 2024-04-23 date: 2024-04-23 name: Federal University of Pelotas class: OTHER briefSummary: Background: Tai Chi Chuan, a Chinese martial art style, is a mind-body modality that has shown positive impacts on health markers in various populations, particularly older adults. This study aims to investigate the effects of a 12-week program of Tai Chi Chuan exercises based on the Yang 16-movement form and walking on older adults' physical and mental markers. |
Methods: This study is a randomized, single-blinded, two-arm, parallel, superiority trial. Forty older adults between 60 and 75 years old who are not engaged in any systematic strength and aerobic training program will be recruited. Candidates with language and cognitive problems, a history of cardiovascular diseases (except controlled hypertension), osteoarticular limitations and fractures, severe injuries, and prosthetic placement in the last six months will be excluded. Participants will be randomly allocated on a 1:1 ratio to a 12-week intervention with Tai Chi Chuan and walking two times per week, or an active-control group with walking two times per week. Physical measures will be muscle strength (i.e., knee extensors maximum strength and lower limbs functional performance -primary outcomes-, dynamic knee extensors endurance, handgrip strength, back-leg-chest strength), functional capacity, static balance, muscle thickness and muscle quality of quadriceps. Mental measures will be quality of life, sleep quality, cognitive function, and depressive and anxiety symptoms. Outcomes will be measured before and after 12 weeks of intervention. The analysis plan will use an intention-to-treat approach and protocol criteria. |
Discussion: The conceptual hypothesis is that the intervention training program with Tai Chi Chuan and walking will lead to greater improvements in both physical and mental parameters due to its multi-component character compared to the walking active-control group. conditions: Aging studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This study is a randomized, single-blinded, two-arm, parallel, superiority trial. Forty healthy and physically inactive subjects, 60 to 75 years of age, are recruited. Participants are randomly allocated on a 1:1 ratio to a 12-week intervention of Tai Chi Chuan plus walking program twice a week, or an active-control group of walking twice a week. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Blinding will be implemented for the outcome assessors. All tests and questionnaires will be supervised by an evaluator blinded to the participant's group. Due to the type of intervention, the investigator conducting exercise sessions and participants will not be blinded. whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: Tai Chi Chuan Plus Walking name: Walking measure: Maximal dynamic strength measure: Functional test - 30-s Chair-stand test measure: Dynamic muscular endurance measure: Isometric handgrip strength measure: Isometric back-leg-chest strength measure: Functional tests - arm curl measure: Functional tests - 8-ft Up-and-Go measure: Functional tests - Chair Sit-and-Reach measure: Functional tests - Back Scratch measure: Funcional tests - 6-min Walk measure: Static balance - 30-second single-leg stance test measure: Quadriceps muscle thickness measure: Quadriceps muscle quality measure: Objective cognitive function - Trail Making Test (TMT) measure: Objective cognitive function - Controlled Oral Word Association Test (COWAT) measure: Quality of Life - Abbreviated World Health Organization Quality of Life (WHOQOL-Bref) measure: Sleep quality - Pittsburgh Sleep Quality Index measure: Depressive and anxiety symptoms is measured using the Hospital Anxiety and Depression Scale (HADS) measure: Body mass measure: Height measure: Waist and hip circumferences measure: Monitoring the intensity of training sessions - Borg Category-Ratio 10 (CR-10) measure: Follow-up questionnaire measure: Adherence assessments measure: Health Questionnaire measure: Level of physical activity - International Physical Activity Questionnaire (IPAQ) - extended version measure: Cognitive screening - Mini-mental state examination (MMSE) sex: ALL minimumAge: 60 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Escola Superior de Educação Física e FIsioterapia city: Pelotas state: Rio Grande Do Sul zip: 96055630 country: Brazil name: Cristine L Alberton, PhD role: CONTACT lat: -31.77194 lon: -52.3425 hasResults: False |
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