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Prehabilitation (Prehab) encompasses a series of interventions that are intended to help patients improve their physical state and psychological well-being pre-intervention to reduce the days of hospitalization and the number of post-operative complications. Patients who participate in Prehab require less postoperative care and consequently have less impact on the cost of the healthcare system. However, adherence to a face-to-face program is usually poor and presents both organizational and psychophysical barriers. In the last years, telerehabilitation has proven to be a viable alternative to face-to-face treatment and has already been adopted for the Prehab. Electrostimulation (ESM) is regularly used successfully in clinical settings for the recovery of muscle tone in patients with orthopedic pathologies. In addition, it has already been used for Prehab, showing an increase in muscle strength and a decrease in postoperative hospital stay following knee arthroplasty. Also Exercise offers benefits in the treatment of orthopedic patients because improve: strength, cardiovascular fitness, functional capacities and quality of life. Therefore, in a group of patients who are candidates for elective lower limb arthroplasty surgery, it was decided to evaluate the effects of a Tele Prehab program, based on the ESM, and compare them with those of an Tele Prehab exercise program, equal in dose and duration. The proposal differs from those present in the literature for complete administration in telerehabilitation, including evaluations. conditions: Osteo Arthritis Knee and Hip conditions: Lower Limb Arthroplasty studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 44 type: ESTIMATED name: ELECTROSTIMULATION (ES) name: EXERCISE (C) measure: Change from baseline in functional capacities on 30 Seconds Chair Stand Test (30CST) at week 4 measure: Change from baseline in functional capacities on Timed Up and Go test (TUG) at week 4. sex: ALL minimumAge: 55 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: "Città di Pavia Healthcare Institute" city: Pavia zip: 27100 country: Italy name: Luca Marin role: CONTACT phone: 0382 433658 phoneExt: +39 email: [email protected] name: Luca Marin role: PRINCIPAL_INVESTIGATOR name: Matteo Chiodarono role: SUB_INVESTIGATOR lat: 45.19205 lon: 9.15917 hasResults: False |
<|newrecord|> nctId: NCT06363630 id: CA073-1000 briefTitle: A Study to Evaluate the Effect of Cytochrome P450 (CYP) 3A Inhibitor (Itraconazole) and Inducer (Rifampin) on the Drug Levels of Golcadomide (BMS-986369) in Healthy Participants overallStatus: NOT_YET_RECRUITING date: 2024-04-16 date: 2024-08-19 date: 2024-08-19 date: 2024-04-12 date: 2024-04-12 name: Celgene class: INDUSTRY briefSummary: The purpose of this study is to evaluate the drug-drug interaction (DDI) potential of coadministration of itraconazole or rifampin on the single dose drug levels of golcadomide. conditions: Healthy Volunteers studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: NONE count: 36 type: ESTIMATED name: Itraconazole name: Rifampin name: Golcadomide measure: Maximum observed plasma concentration (Cmax) measure: Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration (AUC(0-T)) measure: Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) measure: Number of participants with adverse events (AEs) measure: Number of participants with physical exam abnormalities measure: Number of participants with vital sign abnormalities measure: Number of participants with clinical laboratory safety test abnormalities measure: Number of participants with electrocardiogram abnormalities measure: Number of participants with concomitant medications measure: Number of participants with concomitant procedures measure: Time of maximum observed plasma concentration (Tmax) measure: Apparent terminal phase half-life (T-HALF) measure: Apparent total body clearance (CLT/F) measure: Apparent volume of distribution (Vz/F) sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Local Institution - 0001 city: Lenexa state: Kansas zip: 66219 country: United States name: Site 0001 role: CONTACT lat: 38.95362 lon: -94.73357 hasResults: False |
<|newrecord|> nctId: NCT06363617 id: CSAPG-58 briefTitle: Implementation of the Fatty Liver Index in Primary Care acronym: FLI-AP overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-05 date: 2025-05 date: 2024-04-12 date: 2024-04-15 name: Consorci Sanitari de l'Alt Penedès i Garraf class: OTHER briefSummary: This trial aims to evaluate the impact on cardiovascular risk control in individuals in risk of being affected by hepatic steatosis through the implementation of a screening test (Fatty Liver Index) in Primary Care. Medical teams in a primary care center will be divided into 2 groups, with one group using the screening test in their clinical practice. The number of interventions on cardiovascular risk occurring in patients attended by each group of medical teams will be evaluated and compared. conditions: Hepatic Steatosis conditions: Overweight and Obesity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 434 type: ESTIMATED name: FLI measure: Lifestyle Intervention measure: Low-density lipoprotein cholesterol measure: Triglycerides measure: Gamma-glutamyl transpeptidase measure: Medical and nursing visits measure: Analytical checks in the first year measure: Lipid-lowering drugs measure: Healthcare spending measure: FLI administration sex: ALL minimumAge: 14 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Centro de Salud Vilanova i la Geltrú 3 Baix A Mar city: Vilanova I La Geltrú state: Barcelona country: Spain name: M Carmen Rosas, MD role: CONTACT phone: +34 938 10 30 03 email: [email protected] name: Noemí Casaponsa role: CONTACT phone: +34 938960026 phoneExt: 43197 email: [email protected] name: M Carmen Rosas, MD role: PRINCIPAL_INVESTIGATOR lat: 41.22392 lon: 1.72511 hasResults: False |
<|newrecord|> nctId: NCT06363604 id: XHEC-C-2023-128-2 briefTitle: Evaluation of PWI Assisted by Marshall Ethanolization in Ablation of Persistent Atrial Fibrillation overallStatus: RECRUITING date: 2023-12-01 date: 2026-09 date: 2026-11 date: 2024-04-12 date: 2024-04-12 name: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine class: OTHER briefSummary: This is a prospective, randomized controlled, single-blind, multi-center clinical trial study aiming to investigate whether the strategy of posterior wall isolation (PWI) assisted by vein of Marshall ethanol infusion (VOMEI) could improve the success rate of persistent atrial fibrillation ablation. conditions: Atrial Fibrillation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A total of 260 participants with persistent AF who undergo radiofrequency catheter ablation and received VOMEI + PVI will be randomized assigned to two groups at 1:1 ratio. |
Group 0 (Control): VOMEI + PVI + linear ablation of mitral isthmus. Group 1 (Experimental): VOMEI + PVI + linear ablation of mitral isthmus + PWI primaryPurpose: TREATMENT masking: SINGLE maskingDescription: This study used a single-blind design for the subjects. A statistician created a random sequence of numbers using a randomization scheme. The sequence was then placed in opaque coded envelopes and sealed in numerical order. When a patient met the inclusion and exclusion criteria and was assigned a number, the researcher notified the manager to obtain the corresponding envelope and perform the intervention according to the grouping plan inside the envelope. Group 0 correspond to the control group not receiving PWI isolation, while group 1 correspond to the experimental group for PWI isolation. whoMasked: PARTICIPANT count: 260 type: ESTIMATED name: VOMEI + PVI + linear ablation of mitral isthmus name: Posterior wall isolation measure: Recurrence of atrial arrhythmias measure: Procedural complications sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Xinhua Hospital, Shanghai Jiao Tong University status: RECRUITING city: Shanghai state: Shanghai zip: 200092 country: China name: Mu Chen role: CONTACT phone: +86 021 25077275 email: [email protected] lat: 31.22222 lon: 121.45806 hasResults: False |
<|newrecord|> nctId: NCT06363591 id: Wise vs wide briefTitle: Single- vs Two-staged Excisions of Thin Melanoma acronym: WvW overallStatus: NOT_YET_RECRUITING date: 2024-10-01 date: 2034-12-31 date: 2034-12-31 date: 2024-04-12 date: 2024-04-15 name: Vastra Gotaland Region class: OTHER_GOV name: Stockholm Region name: Region Skane name: Region Västerbotten name: Region Örebro County name: Blekinge County Council Hospital name: Region Östergötland name: Dalarna County Council, Sweden briefSummary: The overall aim of this national, multicenter, prospective, randomized, and controlled study is to enhance the management of patients with thin melanoma (≤1 mm Breslow thickness). The investigators hypothesize that wide local excisions (WLEs) following complete excision of thin melanoma do not affect the risk of recurrence, defined as the occurrence of local, regional, distant disease, or melanoma-specific death during a 5- to 10-year follow-up period. conditions: Melanoma (Skin) conditions: Surgery studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Patients with thin (≤1.0 mm) invasive melanomas excised with a histopathological margin ≥1.5 mm will be offered to participate following informed consent and randomization (1:1) to either: |
1. Standard treatment with a WLE of the diagnostic excision scar with a lateral clinical surgical margin of 10 mm and a deep clinical surgical margin down to the muscular fascia as recommended by the Swedish national guidelines. |
or |
2. Experimental treatment with no WLE. primaryPurpose: TREATMENT masking: NONE count: 2486 type: ESTIMATED name: Wise vs wide measure: Recurrence rate at 5 years. measure: Recurrence rate at 10 years. measure: Postoperative complications measure: Scar length, width and quality measure: Scar length, width and quality measure: Patients' quality of life measure: Patient satisfaction measure: Patients' quality of life measure: Patient satisfaction measure: Patients' quality of life measure: Patient satisfaction measure: Direct and indirect costs per patient sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06363578 id: 36264PR604/3/24 briefTitle: Different Doses of Dexmedetomidine in External Oblique Intercostal Plane Block in Splenectomy overallStatus: NOT_YET_RECRUITING date: 2024-04-20 date: 2024-10-01 date: 2024-10-01 date: 2024-04-12 date: 2024-04-12 name: Tanta University class: OTHER briefSummary: The aim of this study is to compare the analgesic effects of different doses of dexmedetomidine as an adjuvant in external oblique intercostal plane block (EOIPB) in splenectomy. conditions: Dexmedetomidine conditions: External Oblique Intercostal Plane Block conditions: Splenectomy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 50 type: ESTIMATED name: Dexmedetomidine 0.5 μg/kg name: Dexmedetomidine 1 μg/kg measure: Time to the 1st rescue analgesia measure: Intraoperative fentanyl consumption measure: Total morphine consumption measure: Degree of pain measure: Heart rate measure: Mean arterial pressure measure: The incidence of adverse events sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tanta University city: Tanta state: El-Gharbia zip: 31527 country: Egypt name: Mohammed S Elsharkawy, MD role: CONTACT phone: 00201148207870 email: [email protected] name: Saad A Moharam, MD role: PRINCIPAL_INVESTIGATOR lat: 30.78847 lon: 31.00192 hasResults: False |
<|newrecord|> nctId: NCT06363565 id: MN-2022-11 briefTitle: Effects of Supplementation of Compound Nutrients on Plasma Homocysteine in Chinese Adults overallStatus: RECRUITING date: 2023-06-01 date: 2025-12-31 date: 2025-12-31 date: 2024-04-12 date: 2024-04-12 name: Sun Yat-sen University class: OTHER briefSummary: The purpose of this study is to determine whether supplementation of compound nutrients, including folic acid, vitamin B6, vitamin B12, and betaine, will decrease the level of plasma homocysteine in Chinese adults with homocysteine levels above 10 μmol/L. conditions: Homocysteine studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 220 type: ESTIMATED name: supplementation of compound nutrients name: placebo control measure: levels of homocysteine sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: SunYat-sen University status: RECRUITING city: Guangzhou state: Guangdong zip: 510080 country: China name: Zhu Huilian role: CONTACT lat: 23.11667 lon: 113.25 hasResults: False |
<|newrecord|> nctId: NCT06363552 id: WETARI briefTitle: A Study of SC-0191 in Subjects With Metastatic Colorectal Cancer overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-04 date: 2025-12 date: 2024-04-12 date: 2024-04-12 name: Tianshu Liu class: OTHER briefSummary: The goal of this clinical trial is to evaluate the preliminary safety and efficacy of SC0191 as single agent or in combination with bevacizumab or 5-FU/LV in advanced colorectal cancer. conditions: Metastatic Colorectal Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 36 type: ESTIMATED name: SC0191 name: SC0191 + Bevacizumab name: SC0191 + 5-FU/LV measure: Objective Response Rate measure: Incidence and Severity of Dose Limiting Toxicities (DLTs) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Zhongshan Hospital Affiliated to Fudan University city: Shanghai state: Shanghai zip: 200032 country: China lat: 31.22222 lon: 121.45806 hasResults: False |
<|newrecord|> nctId: NCT06363539 id: Adeel5 briefTitle: Silver Nitrate Versus Topical Steroid For Umbilical Granuloma overallStatus: COMPLETED date: 2022-09-20 date: 2023-03-20 date: 2023-05-01 date: 2024-04-12 date: 2024-04-12 name: Children Hospital and Institute of Child Health, Lahore class: OTHER briefSummary: Umbilical granuloma is most frequent abnormality of umbilicus in infants that is defined as a moist, fleshy and pink granulation tissue at the center of umbilicus. The most commonly used treatment for umbilical granuloma is silver nitrate cauterization. Various other treatment options for umbilical granuloma include dressing with alcohol and antiseptic solutions, topical table salt, topical steroid application, suture ligation, surgical excision, electrocautery and cryotherapy. Topical steroid ointment is easily available in market, it is cheaper and safer than silver nitrate. OBJECTIVE: To compare the outcome of treatment with silver nitrate versus topical steroid for umbilical granuloma in terms of healing after 3 weeks of treatment. MATERIALS AND METHODS Study Design: Randomized Controlled Trial Setting: Department of Pediatric Surgery, Children Hospital, Lahore Duration: 6 months after approval of synopsis \[Sept 20, 2022 till March 20, 2023\] DATA COLLECTION PROCEDURE 2 After approval of study from hospital Ethical committee \& CPSP, all patients fulfilling the inclusion criteria were admitted through the pediatric surgery outpatient department of The Children's Hospital Lahore. 354 Patients were divided in two equal groups randomly, using lottery method Group A (control group) in which silver nitrate was applied to the lesion once a week and Group B (experimental group) in which topical steroid ointment was applied to the lesion twice a day. Patients were followed after 3 weeks to see healing of umbilical granuloma. Photographs were taken before start of treatment and on regular intervals at each follow up visit. All data was collected by myself. conditions: Umbilical Granuloma studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: randomized control trial primaryPurpose: TREATMENT masking: NONE count: 354 type: ACTUAL name: Clobetasol Propionate .05 Mg in 100 mL TOPICAL LOTION name: Silver Nitrate measure: healing sex: ALL minimumAge: 1 Month maximumAge: 1 Year stdAges: CHILD facility: Children Hospital city: Lahore state: Punjab zip: 42000 country: Pakistan lat: 31.558 lon: 74.35071 hasResults: False |
<|newrecord|> nctId: NCT06363526 id: UMalagaDRIP briefTitle: Effectiveness of 5-week Digital Respiratory Practice in a Group of Children With Duchenne Muscular Dystrophy and Becker Muscular Dystrophy. acronym: DMDrespy2024 overallStatus: NOT_YET_RECRUITING date: 2024-05-05 date: 2024-10-30 date: 2024-11-30 date: 2024-04-12 date: 2024-04-12 name: University of Malaga class: OTHER briefSummary: The purpose of this study is to analyze the effectiveness of a 5-weeks respiratory digital intervention program in patients with Duchenne muscular dystrophy and Becker muscular dystrophy. conditions: Duchenne Muscular Dystrophy conditions: Becker Muscular Dystrophy conditions: Muscular Dystrophy studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: 12 participants were randomized to follow a digital respiratory physiotherapy program for 5 weeks. The participants were evaluated at the beginning and at the end of the study, and the results will be measured before and after each intervention during the study. primaryPurpose: TREATMENT masking: NONE count: 12 type: ESTIMATED name: Digital respiratory intervention program measure: Analyze the improvement of the forced vital capacity (FVC). measure: Perform an anthropometric study of the patient's characteristics, taking into account weight; and also a general physical examination. measure: Perform an anthropometric study of the patient's characteristics, taking into account age. measure: Perform an anthropometric study of the patient's characteristics, taking into account height. measure: Perform an anthropometric study of the patient's characteristics, taking into account sex. measure: Examine changes in forced expiratory pressure measure: Analyze changes in maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP). measure: Check if there are changes in the sniff nasal inspiratory pressure (SNIP) measure: Evaluate the fatigue in patients using an EPInfant test. measure: Evaluate the quality of life of patients using a scale called "Kindscreen-52". sex: ALL minimumAge: 5 Years maximumAge: 20 Years stdAges: CHILD stdAges: ADULT facility: Rocío Martín-Valero city: Málaga country: Spain lat: 36.72016 lon: -4.42034 hasResults: False |
<|newrecord|> nctId: NCT06363513 id: SUR2567-0150 briefTitle: The Efficacy of Aescin in Combination With MPFF in the Early Control of Bleeding From Acute Internal Hemorrhoids, A Randomized Controlled Trial overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-05 date: 2024-05 date: 2024-04-12 date: 2024-04-12 name: Chiang Mai University class: OTHER briefSummary: Hemorrhoidal disease, characterized by symptomatic enlargement and distal displacement of anal cushions, has been a subject of recognition and management for centuries. The etymology of "hemorrhoid" is traced back to the Greek words haima (blood) and rhoos (flow). Prevalent in over 20% of the population across various life stages, this anorectal condition impacts both genders. The multifaceted development of the disease incorporates theories encompassing abnormal dilation of hemorrhoidal plexuses, distension of arteriovenous anastomoses, prolapse of anal pads, and a myriad of genetic, anatomical, dietary, and lifestyle factors. Manifestations range from venous distension to bleeding and thrombosis, with classification based on location (internal/external/combined) and degree of prolapse (grade 1-4). |
Upon comprehensive history-taking and examinations, including digital rectal and proctoscope assessments, a definitive diagnosis is established, leading to the treatment phase. Although outpatient procedures demonstrate efficacy, patients may persist with pain and discomfort. Medical intervention assumes significance for stages 1 and 2, incorporating approaches such as rubber-band ligation, injection sclerotherapy, and dietary modifications. Micronized Purified Flavonoid Fraction (MPFF), integral to hemorrhoid treatment, has been scrutinized for its ability to mitigate pathogenic processes culminating in acute bleeding. The stagnation of blood in vascular plexuses prompts an inflammatory response, activating white cells and increasing vessel wall permeability. MPFF's flavonoid compounds are posited to alleviate bleeding by augmenting venous tone, reducing stasis, inhibiting inflammatory mediators, and enhancing lymphatic drainage\[8\]. Multiple trials substantiate MPFF's efficacy in ceasing bleeding, alleviating symptoms, and preventing hemorrhoid relapse. |
Aescin, a saponin mixture found in Aesculus hippocastanum (horse chestnut). The primary active component, β-aescin, contributes to the plant's medicinal attributes. Experimental investigations in animal models underscore its anti-edematous, anti-inflammatory, and venotonic properties, attributed to molecular mechanisms facilitating ion entry into channels and elevating venous tension. While the therapeutic benefits of aescin for hemorrhoids are acknowledged, the absence of randomized control trials impedes the conclusive validation of its efficacy. In the realm of diverse treatment options, this proposed randomized controlled trial aims to assess the comparative effectiveness of combining aescin with MPFF versus MPFF alone in managing hemorrhoid-related symptoms. The study aspires to furnish valuable insights for refining therapeutic strategies in the management of hemorrhoids and enhancing patient outcomes. conditions: Anorectal Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Aescin in Horse Chestnut name: Flavonoid measure: Cessation of bleeding sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Maharaj Chiang Mai hospital city: Chiangmai state: Maung zip: 50200 country: Thailand name: WITCHA VIPUDHAMORN, FRCS role: CONTACT phone: 0863645085 email: [email protected] lat: 18.79038 lon: 98.98468 hasResults: False |
<|newrecord|> nctId: NCT06363500 id: ChantalIRCB briefTitle: Characterization of HIV-1 Reservoirs in HIV-1 Non-B Infected Adolescents on ART in Cameroon acronym: AVIR overallStatus: COMPLETED date: 2021-11-01 date: 2023-10-30 date: 2023-11-30 date: 2024-04-12 date: 2024-04-12 name: Chantal Biya International Reference Centre for Research on Prevention and Management of HIV/AIDS class: OTHER_GOV briefSummary: Background: Combination antiretroviral therapy (cART) can bring HIV-1 in blood plasma to level undetectable by standard tests and allow a near-normal life expectancy for HIV-infected individuals. Unfortunately, cART is not curative, as within a few weeks of treatment cessation, HIV viremia in most patients rebounds except for rare elite or post-treatment controllers of viremia. The primary source of this rebound is the highly stable reservoir of latent yet replication-competent HIV-1 proviruses integrated into the genomic DNA of resting memory CD4+ T cells. To achieve a cure for HIV, understanding the cell reservoir environment is of paramount importance. The size and nature of viral reservoir might vary per timing of therapy, therapeutic response, ART duration, and immune response. Mechanisms of reservoir maintenance generally depend on levels/type of immune recognition, dynamics of viral persistence are different between pediatric and adult populations, owing to, but not limited to, types/numbers of target cells, efficiency in clearing HIV-infected cells, plasma viremia and HIV drug resistance patterns. This difference could become more evident as these children grow toward adolescence (increasing population due to ART benefits), a stage during which suboptimal adherence is frequent, leading to viral rebound and archiving of resistant patterns. |
Objectives: We plan to conduct a cross sectional study with the aim to characterize HIV reservoirs and their variability according to virological and immunological profiles of non-B HIV-1 vertically infected adolescents receiving antiretroviral therapy. Specifically, we shall (1) evaluate the size of HIV reservoir; (2) Determine HIV-1 genetic variability and drug resistance in cellular reservoirs; (3) Characterize immune activation/inflammation of HIV infected adolescents. |
Methods: We plan to conduct an observational and comparative study involving 90 HIV-1 non-B infected adolescents aged 10-19 years vertically infected, have been on ART for at least 12 months selected from a cohort of the ongoing EDCTP-READY study; intravenous blood will be collected for CD4/CD8 count, plasmatic viral load, PBMCs isolation, immune activation/inflammatory markers, genotyping and Viral reservoir quantification. We will as well recruit a group of 30 HIV-negative adolescents as control for immunological profiling. |
Overall impact: Our findings will help in advancing knowledge on HIV reservoir, in terms of size and genetic variability in adolescents living with HIV (ADLHIV). Such evidence will also help in understanding the effects of ART timing and duration on the size of reservoirs among ADLHIV, a unique population from whom findings generated will largely contribute in designing functional cure strategies in this vulnerable population. conditions: Characterization of HIV Reservoirs in Adolescents studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 140 type: ACTUAL name: non applicable measure: Archived HIV drug resistance mutations measure: HIV-1 reservoirs measurement sex: ALL minimumAge: 10 Years maximumAge: 19 Years stdAges: CHILD stdAges: ADULT facility: Chantal Biya International Reference Centre city: Yaounde state: Centre zip: 99999 country: Cameroon lat: 3.86667 lon: 11.51667 hasResults: False |
<|newrecord|> nctId: NCT06363487 id: R87970/RE001 briefTitle: Semaglutide and Cognition in Healthy Volunteers acronym: OxSENSE overallStatus: NOT_YET_RECRUITING date: 2024-04-08 date: 2024-04-08 date: 2024-06-08 date: 2024-04-12 date: 2024-04-12 name: University of Oxford class: OTHER name: NIHR Oxford Health Biomedical Research Centre briefSummary: Semaglutide is a glucagon-like peptide 1 receptor agonist (GLP-1RA). It is a safe medication approved for use in type-2 diabetes mellitus (T2DM) and obesity. Primarily, it works by counteracting insulin-resistance and inducing weight loss. It also acts on several other interconnected neurobiological, immunological (esp. inflammatory), endocrine-metabolic, and gut-brain axis processes that play a role in depressive symptoms. Its effects on cognition and energy are currently unknown. In this study we are using semaglutide as an experimental tool to further investigate these relationships. conditions: Cognitive Change studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Semaglutide, 0.5 mg/mL name: Placebo, 0.9% NaCl 1.5mL measure: Reward (learning) measure: Reward (effort-based) measure: Reward (primary) measure: Emotional processing measure: Emotional impulsivity measure: Memory (short- and medium-term) processing measure: Memory (working) processing measure: Energy/activity sex: ALL minimumAge: 21 Years maximumAge: 55 Years stdAges: ADULT facility: Department of Psychiatry, University of Oxford city: Oxford state: Oxfordshire zip: OX3 7JX country: United Kingdom lat: 51.75222 lon: -1.25596 hasResults: False |
<|newrecord|> nctId: NCT06363474 id: UHS 5532 briefTitle: Cisternostomy Vs Decompressive Craniectomy for Severe Traumatic Brain Injury overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-05-01 date: 2025-05-01 date: 2024-04-12 date: 2024-04-12 name: University of Health Sciences Lahore class: OTHER briefSummary: The objective of this clinical study is to compare the outcomes of two neurosurgical interventions, Cisternostomy and Decompressive Craniectomy (DC), for the management of severe Traumatic Brain Injury (TBI), assessed using the Glasgow Outcome Scale (GOS). Severe TBI presents challenges in managing intracranial pressure (ICP) and cerebral perfusion, often requiring surgical intervention. DC involves the removal of a section of the skull to reduce ICP, while Cisternostomy, a technique rooted in microsurgery, aims to alleviate brain edema and lower ICP by creating additional space for cerebrospinal fluid (CSF) circulation. |
This prospective study will be conducted at the Department of Neurosurgery, Punjab Institute of Neurosciences, Lahore. Patients meeting inclusion criteria will be randomized into Group A (DC) and Group B (Cisternostomy) following brain CT scans. Clinical evaluation will include regular follow-ups for 6 months post-surgery, recording data on GOS, duration of mechanical ventilation, ICU, and hospital stays. Analysis will be performed using SPSS 24, comparing outcomes between groups using Chi-square test and t-test. A significance level of p≤0.05 will be applied. |
It is hypothesized that Cisternostomy, as an adjunct to traditional TBI management, will effectively reduce ICP, resulting in improved GOS and reduced complications postoperatively, including decreased duration of mechanical ventilation and ICU stay, with sustained improvement observed at 6 months conditions: Severe Traumatic Brain Injury studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The intervention model of this study is a parallel model. Patients meeting inclusion criteria are enrolled from the neurosurgery department of Punjab Institute of Neurosciences, Lahore. After obtaining consent, patients undergo detailed assessments and investigations. They're randomly assigned to Group A (decompressive craniectomy) or Group B (cisternostomy). Both procedures are performed by a single surgical team under anesthesia. Postoperatively, patients are monitored for mechanical ventilation duration, ICU and hospital stay lengths, and Glasgow Outcome Scale at discharge. This model enables outcome comparison between intervention groups while controlling confounding variables. primaryPurpose: TREATMENT masking: NONE count: 190 type: ESTIMATED name: Decompressive Craniectomy name: Cisternostomy measure: comparison of patient outcomes between the two intervention groups (Decompressive Craniectomy and Cisternostomy) in terms of the Glasgow Outcome Scale (GOS). sex: ALL maximumAge: 60 Years stdAges: CHILD stdAges: ADULT hasResults: False |
<|newrecord|> nctId: NCT06363461 id: 239-13851-202 briefTitle: Study of TDM-180935 in Atopic Dermatitis Patients overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2024-09-30 date: 2024-10-31 date: 2024-04-12 date: 2024-04-12 name: Technoderma Medicines Inc. class: INDUSTRY name: Therapeutics, Inc. briefSummary: Randomized, Vehicle-controlled, Parallel Group Study of TDM-180935 in Atopic Dermatitis Patients conditions: Atopic Dermatitis studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 24 type: ESTIMATED name: TDM-180935 topical ointment 1.0% name: TDM-180935 topical ointment 2.0% name: TDM-180935 topical vehicle ointment 1 name: TDM-180935 topical vehicle ointment 2 measure: Change in m-EASI (modified Eczema Area and Severity Index) score measure: Proportion of patients with a ≥ 2 point improvement in vIGA-AD score (validated Investigator's Global Assessment for Atopic Dermatitis score) measure: Change in m-EASI (modified Eczema Area and Severity Index) score measure: Proportion of patients with a 50% improvement in m-EASI (modified Eczema Area and Severity Index) score measure: Proportion of patients with a 75% improvement in m-EASI (modified Eczema Area and Severity Index) score measure: Proportion of patients with a 90% improvement in m-EASI (modified Eczema Area and Severity Index) score measure: Change in BSA (body surface area) affected measure: Proportion of patients with a 4-point improvement from Baseline in WI-NRS (Worst Itch-Numeric Rating Scale) score measure: Incidence (severity and causality) of any local and systemic AEs (adverse events) measure: Number of patients with presence (and severity) of the following LSRs (local skin reactions): skin pigmentation (hyperpigmentation and hypopigmentation), edema, erosion,scaling, and burning/stinging measure: Changes from Baseline in vital signs (temperature) measure: Changes from Baseline in vital signs (systolic and diastolic blood pressure) measure: Changes from Baseline in vital signs (heart rate) measure: Changes from Baseline in vital signs (respiration rate) measure: Changes from baseline in clinical laboratory tests (including Blood Chemistries, Hematology, and Urinalysis) measure: Number of participants with abnormal ECG readings sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Site 3 city: Rolling Meadows state: Illinois zip: 60008 country: United States lat: 42.08419 lon: -88.01313 facility: Site 7 city: Covington state: Louisiana zip: 70433 country: United States lat: 30.47549 lon: -90.10042 facility: Site 5 city: New Brighton state: Minnesota zip: 55112 country: United States lat: 45.06552 lon: -93.20189 facility: Site 6 city: Anderson state: South Carolina zip: 29621 country: United States lat: 34.50344 lon: -82.65013 facility: Site 1 city: Austin state: Texas zip: 78759 country: United States lat: 30.26715 lon: -97.74306 facility: Site 4 city: College Station state: Texas zip: 77845 country: United States lat: 30.62798 lon: -96.33441 facility: Site 2 city: Norfolk state: Virginia zip: 23502 country: United States lat: 36.84681 lon: -76.28522 hasResults: False |
<|newrecord|> nctId: NCT06363448 id: Soh-Med-24-3-04PD briefTitle: Yamani Technique Versus Proline Mesh for Intraocular Lens Scleral Fixation in Aphakia overallStatus: RECRUITING date: 2024-01-01 date: 2024-06-30 date: 2024-07-30 date: 2024-04-12 date: 2024-04-12 name: Sohag University class: OTHER briefSummary: The study aims to describe a new method of sulcus fixation of intraocular lenses (IOLs) using a prolene mesh and to compare its outcomes with Yamani technique. conditions: Aphakia, Postcataract studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 20 type: ESTIMATED name: Yamani Technique versus Prolene Mesh for Intraocular Lens Scleral Fixation in Aphakia measure: Best corrected visual acuity (BCVA) in LogMAR sex: ALL minimumAge: 40 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ophthalmology department, Sohag University status: RECRUITING city: Sohag zip: 82511 country: Egypt name: Elshimaa A.Mateen role: CONTACT phone: 0201282223427 email: [email protected] lat: 26.55695 lon: 31.69478 facility: Elshimaa A.Mateen status: RECRUITING city: Sohag country: Egypt name: Elshimaa A.Mateen, Doctor role: CONTACT phone: 0201282223427 email: [email protected] lat: 26.55695 lon: 31.69478 hasResults: False |
<|newrecord|> nctId: NCT06363435 id: #2022-01302-02-PSMA briefTitle: AI-based Measurements of Tumour Burden in PSMA PET-CT overallStatus: RECRUITING date: 2024-03-29 date: 2031-03 date: 2033-03 date: 2024-04-12 date: 2024-04-12 name: Elin Tragardh class: OTHER name: Lund University briefSummary: The primary aim of the present study is to evaluate how automatically calculated (by an AI-based method) tumour burden, measured as tumour volume (TV) and as tumour uptake (TU: TV x SUVmean) in the prostate/prostate bed, pelvic lymph nodes, distant lymph nodes, bone and as the total tumour burden predicts overall survival (OS) in patients with prostate cancer (newly diagnosed and patients with biochemical recurrence). conditions: Prostate Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1500 type: ESTIMATED name: AI-based detection and quantification of suspected tumour/metastases in PSMA PET/CT scans measure: Tumour burden (cm3) in relation to overall survival measure: Tumour burden (cm3) in relation to biochemical recurrence measure: Number of tumours/metastases in relation to OS measure: Comparing two different segmentation methods in relation to OS measure: Comparing total tumour burden (cm3) measured manually and by the AI-based mehtod sex: MALE minimumAge: 20 Years maximumAge: 120 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Skåne University Hospital status: RECRUITING city: Lund country: Sweden name: Elin Tragardh, Prof role: CONTACT phone: +4640338724 email: [email protected] lat: 55.70584 lon: 13.19321 facility: Skåne university hospital status: RECRUITING city: Malmö country: Sweden name: Elin Tragardh, Prof role: CONTACT phone: +4640338724 email: [email protected] lat: 55.60587 lon: 13.00073 hasResults: False |
<|newrecord|> nctId: NCT06363422 id: JY2024-012 briefTitle: The Value of Epicanthoplasty on the Modification of Upper-eyelid Appearance overallStatus: COMPLETED date: 2024-01-01 date: 2024-03-15 date: 2024-04-01 date: 2024-04-12 date: 2024-04-12 name: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University class: OTHER briefSummary: In East Asian populations, the combination of an epicanthic fold and mono-eyelid is one of their anatomical characteristics. Misalignment of the orbicularis oculi muscle and fibrous connections leads to longitudinal tension, forming the epicanthic fold. The epicanthic fold may diminish the aesthetic effects of eyelid cosmetic surgery, shorten the horizontal length, and affect the postoperative shape of double eyelids. As upper eyelid cosmetic surgery is one of the most common cosmetic procedures in Asia, there is increasing attention on the modification of the epicanthic fold and its impact on the formation of double eyelids. conditions: Patient Satisfaction conditions: Epicanthus; Fold studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: RETROSPECTIVE count: 14 type: ACTUAL name: Epicanthoplasty measure: inter-epicanthal distance (IED) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Shanghai ninth people's hospital city: Shanghai country: China lat: 31.22222 lon: 121.45806 hasResults: False |
<|newrecord|> nctId: NCT06363409 id: 2023-1353 briefTitle: The Acute and Accumulative Effects of Snack Foods on Exercise Recovery overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2026-06-01 date: 2027-01-01 date: 2024-04-12 date: 2024-04-12 name: San Diego State University class: OTHER briefSummary: The purpose of the research is two-fold. One goal is to determine if post-exercise almond or cereal bar consumption can promote muscle gain as well as increasing muscular strength throughout an eight-week weight training program. The other goal is to assess the short-term effects of almonds or cereal bar on recovery that may explain the overall long-term adaptations. conditions: Muscle Strength studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 60 type: ESTIMATED name: Cereal Bar as a recovery food snack name: Almond measure: delayed onset of muscle soreness measure: markers of muscle damage measure: changes in strength measure: changes in body composition sex: ALL minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT hasResults: False |
<|newrecord|> nctId: NCT06363396 id: K 2023-7081 briefTitle: Fatigue and Cognitive Dysfunction After Allogeneic Stemcell Transplantation, Prospective PET Study overallStatus: RECRUITING date: 2024-02-22 date: 2026-02-22 date: 2027-02-22 date: 2024-04-12 date: 2024-04-12 name: Karolinska Institutet class: OTHER name: Karolinska University Hospital briefSummary: This study is the academic study and continuation and further development of a prior project under the leadership of Professor LeBlanc. Patients undergoing allogenic stem cell transplantation are followed up in the outpatient clinic. Here, patients are offered participation the fatigue study measuring both fatigue and cognitive impairment systematically by international standard. Previous study by Boberg et al suggested distinct mRNA and proteomic profiles segregating fatigued from non-fatigued patients as well as patients with or without cognitive impairment. A larger well-defined patient cohort is necessary to confirm these results. Investigators aim to identify specific sets of proteins in the CSF that can serve as potential biomarkers of cognitive dysfunction and/or fatigue. This will be performed with two methods: |
* by using mass spectrometry-based proteomics approaches |
* Olink technology |
PET examinations will be performed on both fatigued and non-fatigued. We will utilize the second generation TSPO radioligand \[ 11C\]PBR28 as well as the SV2A radioligand \[ 11C\]UCB-J, both showing high signal-to-noise ratio and adequate test-retest properties. conditions: Fatigue conditions: Cognitive Dysfunction studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 30 type: ESTIMATED measure: Results of cognitive tests measure: Potential biomarkers for fatigue and cognitive dysfunction measure: PET results measure: Global analyses of the neural connections sex: ALL minimumAge: 20 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Karolinska status: RECRUITING city: Stockholm zip: 14186 country: Sweden name: Ksenia Boriskina, MD role: CONTACT phone: 0858580675 email: [email protected] name: Kirsti Niemelä, study nurse role: CONTACT name: Katarina Le Blanc, professor role: PRINCIPAL_INVESTIGATOR lat: 59.33258 lon: 18.0649 hasResults: False |
<|newrecord|> nctId: NCT06363383 id: MB-001-101 briefTitle: A Phase 1 Study to Evaluate the Safety of an Oral Biologic in Healthy Participants overallStatus: RECRUITING date: 2024-05-09 date: 2025-05 date: 2025-05 date: 2024-04-12 date: 2024-04-18 name: Mage Biologics class: INDUSTRY name: Alimentiv Inc. briefSummary: The goal of this clinical trial is to learn if the oral biologic MB-001 is safe in healthy volunteers. The main questions it aims to answer are: |
Is the drug safe when administered orally at increasing doses? Researchers will compare the drug with placebo to see if there are more side effects in those receiving the drug. |
Participants will receive a single or five daily doses of the drug or placebo and will be asked to stay in the clinic for five days following the last dose. conditions: Ulcerative Colitis studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: two-stage, single-center, double-blinded, randomized, placebo-controlled primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: double-blinded using matching placebo capsules containing matching pellets whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 48 type: ESTIMATED name: MB-001 measure: Incidence and severity of adverse events (AEs) measure: Clinically significant changes from baseline in vital signs measure: Clinically significant changes from baseline in physical examination findings measure: Clinically significant changes from baseline in clinical laboratory assessments measure: Clinically significant changes from baseline in ECG parameters measure: Area under the concentration-time curve measure: Maximum plasma concentration measure: Time to reach observed maximum plasma concentration after administration measure: Trough concentration sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CMAX status: RECRUITING city: Adelaide state: South Australia zip: 5000 country: Australia name: Jessica Lehman role: CONTACT phone: +61 8 7088 7900 email: [email protected] lat: -34.92866 lon: 138.59863 hasResults: False |
<|newrecord|> nctId: NCT06363370 id: KXZY-GB05-201 briefTitle: Human Interferon α1b Inhalation Solution Against Respiratory Syncytial Virus in Children With Lower Respiratory Tract Infections overallStatus: RECRUITING date: 2024-03-27 date: 2026-06-30 date: 2026-06-30 date: 2024-04-12 date: 2024-04-12 name: Kexing Biopharm Co., Ltd. class: INDUSTRY briefSummary: To evaluate the efficacy and safety of interferon α1b (GB05) in the treatment of children under 2 years of age with respiratory syncytial virus infection. conditions: Respiratory Syncytial Virus Infections studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 322 type: ESTIMATED name: Human interferon α1b Inhalation Solution name: Inhalation Solution Placebo measure: Wang bronchiolitis score chanced by percentage from baseline measure: Wang bronchiolitis score chanced by percentage from baseline measure: Wang bronchiolitis score of 0 in proportion measure: Wang bronchiolitis score total score < 5 points measure: Wang bronchiolitis score, the first time the total score reaches < 5 points measure: RSV viral load sex: ALL minimumAge: 2 Months maximumAge: 2 Years stdAges: CHILD facility: Children's Hospital, Capital Institute of Pediatrics status: RECRUITING city: Beijing state: Beijing zip: 100000 country: China name: Ling Cao, MD role: CONTACT phone: 13910610319 lat: 39.9075 lon: 116.39723 hasResults: False |
<|newrecord|> nctId: NCT06363357 id: 24B-007-0000 briefTitle: The Effect of a Muscle-mimicking, Fabric-type Shoulder Orthosis on Functional Movements of the Upper Limb in Patients With Duchenne Muscular Dystrophy overallStatus: NOT_YET_RECRUITING date: 2024-04-20 date: 2025-12-31 date: 2025-12-31 date: 2024-04-12 date: 2024-04-12 name: Seoul National University Hospital class: OTHER briefSummary: The goal of this clinical trial is to investigate the effect of a muscle-mimicking, fabric-type shoulder orthosis on functional movements of the upper limb in patients with Duchenne muscular dystrophy. |
The main questions it aims to answer are: |
* What is the impact of the muscle-mimicking, fabric-type shoulder orthosis on upper limb functional movements in patients with Duchenne muscular dystrophy? |
* Are there observable differences in upper limb function when the shoulder orthosis is worn versus when it is not? |
Participants will: |
* Receive education on how to wear and use the shoulder orthosis. |
* Undergo evaluations, including assessment of upper limb performance, shoulder muscle strength testing, active range of motion measurements, assessment of functional workspace, goal attainment scale evaluation, surface electromyography, physiological measurements such as blood pressure and heart rate, fatigue assessment, and assessment for any musculoskeletal or skin-related issues. |
Researchers will compare Duchenne muscular dystrophy patients before and while wearing and operating the shoulder orthosis to see if there are any significant effects on variables such as upper limb function, range of motion, functional workspace, goal attainment scale, and surface electromyography. conditions: Muscular Dystrophy, Duchenne conditions: Orthotic Devices conditions: Upper Extremity studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: This study compares variables before and after wearing the shoulder orthosis in patients with Duchenne muscular dystrophy. primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 30 type: ESTIMATED name: Shoulder orthosis measure: Performance of the upper limb module 2.0 (PUL 2.0) measure: Active Range of motion measure: Functional workspace measure: Goal Attainment Scale (GAS) measure: Surface electromyography (sEMG) sex: ALL minimumAge: 10 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Seoul National University Hospital city: Seoul state: Jongno-gu zip: 03080 country: Korea, Republic of name: Woo Hyung Lee, MD, Ph.D role: CONTACT phone: +82-2-2072-4178 email: [email protected] lat: 37.566 lon: 126.9784 hasResults: False |
<|newrecord|> nctId: NCT06363344 id: APHP231022 id: IDRCB: 2023-A00660-45 type: REGISTRY domain: IDRCB ANSM briefTitle: Follow-up in Pediatric Intensive Care Unit acronym: APRELAREA overallStatus: RECRUITING date: 2024-04-01 date: 2025-04-01 date: 2025-09-01 date: 2024-04-12 date: 2024-04-15 name: Assistance Publique - Hôpitaux de Paris class: OTHER briefSummary: Background In developed countries, mortality rates in pediatric intensive care units (PICUs) are around 4% and thus, most children admitted to these units survive. However, some pediatric survivors experience long-term morbidity (cognitive, psychological, social and/or physical disorders) associated with their intensive care stay. Currently in France, there are no recommendations for the management of these patients and most of them do not have standardized follow-up. |
Objectives Main objective: To assess the feasibility of implementing systematic and comprehensive management of pediatric patients who have been admitted to the PICU. |
Intermediate objectives are to study: |
* The needs of the children and their families which should be met by this management |
* The acceptability of this organizational innovation for all the actors involved |
* The cooperation between actors of the hospital and city health system + social professionals involved |
* The costs of implementation and the budgetary impact of such a system |
Methods Needs assessment: questionnaires and interviews with patients and their families (parents and possibly siblings if involved) to collect the medico-psycho-social impact of the PICU stay at the time of discharge and 3 months later. |
Study of acceptability: quantitative survey of health professionals involved in the care of these children and expected care modalities. This includes pediatric intensivists, professionals from the children's usual care services (if applicable), attending physician. |
Study of cooperation: analysis of needs and of the network usually solicited for the children benefiting from this care: who is identified, who remains to be identified, obstacles. Quantitative analysis of consultation reports and survey of professionals. |
Budgetary impact analysis: study of the cost of setting up consultations for the health care system, and study of its financial and health consequences for the main needs identified, on the basis of data from the literature and expert opinions |
Perspectives Compare the benefit of this systematic, multi professional and comprehensive management of pediatric patients after PICU discharge versus standard of care conditions: Intensive Care Psychosis studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 120 type: ESTIMATED name: Questionnaires : PHQ-9 (Kroenke, 2001), the PSC (Sheldrick, 2012), the ASQ-SE (Squires, 2015), the PedsQL (Varni, 1999) measure: Emotional and behavioral problem of the children measured by the PSC questionnaire (Sheldrick, 2012) measure: Mental disorders measured by the PHQ-9 (Kroenke, 2001) questionnaire measure: Social-emotional development measured by the ASQ-SE (Squires, 2015) questionnaire measure: Pediatric Quality of Life measured by the the PedsQL (Varni, 1999) questionnaire sex: ALL minimumAge: 1 Day maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Robert Debre Hospital status: RECRUITING city: Paris zip: 75019 country: France name: Michaël LEVY, MD, PhD role: CONTACT phone: +33.1.40.03.40.98 email: [email protected] name: Enora LE ROUX, PhD role: CONTACT phone: +33.1.40.03.23.66 email: [email protected] lat: 48.85341 lon: 2.3488 hasResults: False |
<|newrecord|> nctId: NCT06363331 id: 2020I054 briefTitle: Efficacy of the Social Cognition Rehabilitation Program E-motional Training in the Treatment of Patients With Substance-related Disorders overallStatus: COMPLETED date: 2022-03-01 date: 2022-12-01 date: 2023-12-30 date: 2024-04-12 date: 2024-04-12 name: Fundacin Biomedica Galicia Sur class: OTHER briefSummary: Drug use, substance use disorders (SUD) and other addictive behaviors are problems of enormous socio-health impact that still require a great research effort to improve the diagnostic and therapeutic procedures used in healthcare practice. |
Since addictive behaviors have been consistently associated with the presence of alterations in cognitive and executive functions, it is necessary to be able to detect, evaluate and have specific therapies for these dysfunctions and investigate, among other issues, the role they play in the onset and course evolutionary. After implementing neuropsychological evaluation techniques for diagnostic improvement, addresses the search for procedures that allow working on cognitive and executive deficits, as a specific therapeutic target. |
To characterize the presence of alterations in the domains that make up social cognition (SC) in patients with SUD and test in our healthcare units the ET® program already tested both experimentally and at beta level. It is an online self-training program for CS rehabilitation that includes modules for emotion recognition (RE), Theory of Mind (ToM) and attributional style (AS). |
To replicate the RCT carried out in schizophrenia in patients with SUD with difficulties in RE or ToM, in addition to searching for a biomarker or a pattern of them that predict the patient profile that will benefit from the training, using advanced LC-ESI proteomics techniques. MS/MS in saliva since previous studies in a population with schizophrenia, subjected to different neurorehabilitation therapies. It is also intended to subsequently improve the instrument (ET®) through the implementation of big data analysis and machine learning and the introduction of automated user management. At this level, the objective is to determine, after the first games, the type of game and the intensity required to improve the user's performance until it reaches normality. |
From the perspective of the State Plan for Scientific and Technical Research and Innovation, this project combines CLINICAL AND TRANSLATIONAL RESEARCH, based on the evidence of scientific and technological knowledge, and the use of ENABLING TECHNOLOGIES of e-health in the area of Health Services. Health for people with SUD. conditions: Social Behavior studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 231 type: ACTUAL name: Emotional Training measure: Assess the presence of dysfunctions in the subdomains of social cognition measure: Accuracy and efficacy of ET® in patients with SDB sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Galicia Sur Health Research Institute (IISGS) - Hospital Álvaro Cunqueiro city: Vigo state: Pontevedra zip: 36213 country: Spain lat: 42.23282 lon: -8.72264 facility: Galicia Sur Health Research Institute city: Vigo state: Pontevedra zip: 36213 country: Spain lat: 42.23282 lon: -8.72264 hasResults: False |
<|newrecord|> nctId: NCT06363318 id: 0003 briefTitle: Comparison of Open and Laparoscopic Appendectomy in Pediatric Population acronym: Appendicitis overallStatus: COMPLETED date: 2019-07-01 date: 2019-11-30 date: 2019-11-30 date: 2024-04-12 date: 2024-04-15 name: King Edward Medical University class: OTHER briefSummary: Introduction: In the era of minimally invasive surgery, changing trends are towards laparoscopic surgery, first introduced in 1983. Now the preferred operation for children with appendicitis, laparoscopic appendectomy is associated with a reduced risk of wound infection, less postoperative pain and shorter hospital stay as compared to open appendectomy. |
Objectives: To compare the outcome of open and laparoscopic appendectomy in children presenting with appendicitis in terms of operative time, postoperative pain, wound infection and hospital stay. conditions: Appendicitis Acute studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: children were randomly divided in two groups. In group A, laparoscopic appendectomy was done. In group B, open appendectomy was done primaryPurpose: TREATMENT masking: NONE count: 100 type: ACTUAL name: Laparoscopic appendicectomy measure: Operative time measure: wound infection measure: Hospital stay measure: Postoperative pain sex: ALL minimumAge: 7 Years maximumAge: 12 Years stdAges: CHILD facility: Muhammad Sharif city: Lahore state: Punjab zip: 53711 country: Pakistan lat: 31.558 lon: 74.35071 hasResults: False |
<|newrecord|> nctId: NCT06363305 id: 2402-1139 briefTitle: Impact of Sex in the Effect of Dietary Capsaicin on Cardiovascular Health overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-12-01 date: 2025-12-31 date: 2024-04-12 date: 2024-04-18 name: Skidmore College class: OTHER name: American Heart Association briefSummary: The investigators long-term goal is to better understand novel interventions to promote cardiovascular health in humans. The goal of the proposed research is to investigate whether there is sex-specificity in the effects of dietary capsaicin on mechanisms regulating nitric oxide (NO) bioavailability, its effect on key markers of cardiovascular (CV) health, including BP, macro- and microvascular function, and arterial stiffness. This knowledge will provide critical insight into the effects of dietary capsaicin on CV health and will guide future trials. conditions: Pre Hypertension conditions: Hypertension studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Parallel: Participants are randomly assigned to one of two groups in parallel for the duration of the study primaryPurpose: BASIC_SCIENCE masking: TRIPLE maskingDescription: The capsules will be placed into solid white color bottles, and labeled discreetly by a third party not directly involved with the research. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Dietary capsules measure: Blood Pressure and Vascular Stiffness measure: Heart Rate (HR) and HR variability (HRV) measure: Flow Mediated Dilation measure: Passive Leg Movement Hyperemia measure: Near Infrared Spectroscopy (NIRS) Vascular Occlusion Test measure: Urinary Capsaicinoids measure: Blood Lipids sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Skidmore College city: Saratoga Springs state: New York zip: 12866 country: United States name: Stephen Ives, Ph.D. role: CONTACT phone: 518-580-8366 email: [email protected] lat: 43.08313 lon: -73.78457 hasResults: False |
<|newrecord|> nctId: NCT06363292 id: SOPH231-1221/I briefTitle: Study to Evaluate the Safety and Tolerability of PRO-231 Ophthalmic Solution Versus VIGAMOXI® on the Ocular Surface of Healthy Subjects. overallStatus: RECRUITING date: 2024-01-30 date: 2024-05-30 date: 2024-05-30 date: 2024-04-12 date: 2024-04-15 name: Laboratorios Sophia S.A de C.V. class: INDUSTRY briefSummary: This is a phase I clinical study evaluating the safety and tolerability of PRO-231 ophthalmic solution through the incidence of unexpected adverse events, incidence of conjunctival hyperemia and chemosis, changes in Best Corrected Visual Acuity (BCVA), changes in ocular surface integrity, compared to VIGAMOXI®. conditions: Ophthalmological Agent Toxicity conditions: Bacterial Conjunctivitis studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Phase I, controlled, comparative, parallel-group, single-blind, single-center, controlled clinical trial. primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: Single-blind whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 36 type: ESTIMATED name: PRO-231 name: VIGAMOXI® measure: Incidence of unexpected adverse events related to the interventions measure: Incidence of conjunctival hyperemia and chemosis measure: Changes in Best Corrected Visual Acuity (BCVA) measure: Changes in the integrity of the ocular surface (fluorescein staining) measure: Changes in the Ocular Comfort Index (OCI) score between interventions. measure: Incidence of unexpected adverse events (excluding conjunctival hyperemia and chemosis) measure: To assess the tolerability of PRO-231 ophthalmic solution sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: IIMET Investigación e Innovación en Medicina Traslacional status: RECRUITING city: Guadalajara state: Jalisco zip: 44610 country: Mexico name: Alejandro González, MD role: CONTACT lat: 20.66682 lon: -103.39182 hasResults: False |
<|newrecord|> nctId: NCT06363279 id: 2024/24JAN/044 briefTitle: Validation of the French ATI Scale and Predisposition to Use Technological Tools in Rehabilitation. overallStatus: RECRUITING date: 2024-04-04 date: 2024-09 date: 2024-10 date: 2024-04-12 date: 2024-04-12 name: Cliniques universitaires Saint-Luc- Université Catholique de Louvain class: OTHER briefSummary: Aim of the study: The first aim of this study is to validate the translation of the Affinity for Technology Interaction (ATI) questionnaire. This questionnaire was developed in English by Franke, Attig and Wessel in 2019. It consists of 9 items and was developed to assess a person's tendency to actively engage in technological interaction, or the ease with which a person uses technological tools. Currently, the questionnaire has been translated into French by our research team according to good practice recommendations (Guillemin, Bombardier and Beaton, 1993; Tsang et al., 2017), but this French version has not yet been validated. To validate the translation of a questionnaire, it is necessary to have it completed by a large number of subjects from the population of interest. In neurorehabilitation, measuring this affinity will make it possible to better identify patients who are more likely to adhere to tele-rehabilitation and thus direct them towards this type of treatment as a complement to conventional rehabilitation. |
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