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* complete baseline clinical measures
* complete neuroimaging tasks via Functional Magnetic Resonance Imaging (fMR)
* undergo a 12-session course of FFT-CD
* complete follow up evaluations and neuroimaging conditions: Childhood Depression studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 80 type: ESTIMATED name: Family-Focused Treatment for Childhood-Depression (FFT-CD) measure: Depression Treatment Response measure: Children's Self Report of Depressive Symptoms measure: Depression Remission sex: ALL minimumAge: 7 Years maximumAge: 12 Years stdAges: CHILD facility: Boston University city: Boston state: Massachusetts zip: 02215 country: United States name: Martha C Tompson, PhD role: CONTACT phone: 617-358-4584 email: mtompson@bu.edu name: Natalie Marr, BS role: CONTACT phone: 6173539610 email: nmarr@bu.edu name: Martha C Tompson, PhD role: PRINCIPAL_INVESTIGATOR lat: 42.35843 lon: -71.05977 facility: Athinoula A. Martinos Imaging Center at Massachusetts Institute of Technology city: Charlestown state: Massachusetts zip: 02129 country: United States name: John DE Gabrieli, PhD role: CONTACT phone: 617-253-8946 email: gabrieli@mit.edu name: John DE Gabrieli, PhD role: PRINCIPAL_INVESTIGATOR lat: 42.37787 lon: -71.062 hasResults: False
<\|newrecord\|> nctId: NCT06288997 id: TFYuan_tACS briefTitle: tACS Intervention for Methamphetamine Addiction acronym: tACS for MUD overallStatus: COMPLETED date: 2021-11-21 date: 2023-05-09 date: 2023-11-09 date: 2024-03-01 date: 2024-03-01 name: Shanghai Mental Health Center class: OTHER briefSummary: A growing body of evidence suggests a wide range of brain areas are critical for regulating cognitive control over decisions and involving in drug related cue processing. Previous studies have demonstrated that transcranial alternating current stimulation (tACS) over prefrontal cortex reduces craving for meth dependences. In this study, the investigators investigated whether a current level of 15mA with a patented frequency of 77.5Hz tACS intervention of prefrontal cortex cortices in methamphetamine addiction could reduce the subjective craving and improve the cognitive abilities. conditions: Methamphetamine-dependence studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 23 type: ACTUAL name: transcranial alternating current stimulation name: sham tACS measure: Changes of Cue-induced craving measure: Changes of cognition: behavioral inhibition measure: Changes of cognition: choice under ambiguity measure: changes of neural mechanism measure: Changes of depression status measure: Changes of anxiety status measure: Changes of sleep status measure: Changes of impulsivity measure: event-related potential in passive viewing task measure: side effect measurements sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Beijing Tiantanghe Addiction Rehab Center city: Beijing state: Beijing zip: 100054 country: China lat: 39.9075 lon: 116.39723 hasResults: False
<\|newrecord\|> nctId: NCT06288984 id: NFEC-2024-061 briefTitle: Effects of rTMS on Respiratory Function and Gut Microbiota in Patients With Brain Injury overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2026-06-30 date: 2026-12-31 date: 2024-03-01 date: 2024-03-01 name: Nanfang Hospital, Southern Medical University class: OTHER briefSummary: Impaired respiratory function may occur after brain injury, and will progress to restricted respiratory dysfunction without early intervention. At present, there is a lack of effective treatment options for respiratory dysfunction. Repetitive Transcranial Magnetic Stimulation(rTMS) is a non-invasive, painless and non-invasive neuroregulatory technique. In healthy people, rTMS applied to the respiratory motor cortex induces a contralateral respiratory muscle response. However, whether rTMS can improve respiratory function in patients with brain injury remains unclear. gut microbiota can affect muscle function and mass, and animal experiments have shown that probiotics can increase skeletal muscle mass and grip strength in mice. On the other hand, studies have found that rTMS can improve the nutritional status of patients with vegetative state by regulating the structure of gut microbiota. However, it remains unclear whether rTMS can improve respiratory muscle function in patients with brain injury by regulating gut microbiota. Therefore, the investigators intend to apply rTMS to the respiratory motor cortex to observe whether rTMS can improve respiratory function and reduce the incidence of pneumonia in patients with brain injury, and to observe the role of gut microbiota in this process. conditions: Brain Injuries conditions: Respiratory Function Impaired conditions: Gut Microbiota studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 74 type: ESTIMATED name: active rTMS name: sham rTMS measure: Diaphragm thickness measure: Thickening fraction measure: Diaphragm mobility measure: Surface EMG of diaphragm measure: Forced vital capacity(FVC) measure: Forced expiratory volume at one second（FEV1） measure: Peak expiratory flow (PEF) measure: Maximum voluntary ventilation (MVV) sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06288971 id: IRCCS FSM briefTitle: Personalized Innovative Intervention Pathways to Promote EF in Children With CP overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2027-01-31 date: 2027-03-01 date: 2024-03-01 date: 2024-03-01 name: IRCCS Fondazione Stella Maris class: OTHER name: University of Pisa name: University of Florence name: Anastasis Società Cooperativa Sociale briefSummary: Cerebral palsy (CP) is an umbrella term, covering a group of disorders of movement and posture. It is now accepted that CP represents much more than a disorder of movements considering the frequent association with a broad range of impairments, including cognitive impairments. In general, multiple clinical characteristics that define and determine different functional profiles. Several studies on children with unilateral and bilateral CP have been shown that, despite the overall preserved intellectual functioning, there are specific neuropsychological impairments distinguishing the two forms, including deficits in different Executive Functions (EF) components. Executive Functions (EFs) represent a complex cognitive domain consisting of a set of top-down functions essential for adaptive goal-directed behaviour, allowing to formulate, plan, and organise ideas, cope with challenges and novelties, resist temptations and stay focused. EF represents general domain abilities transversal to several cognitive processes and underling different daily life activities and school learning skills. Empowering EF becomes therefore crucial in children with CP both to strengthen specific functional EF weaknesses and to achieve far transfer effects on other compromised domains, such as motor planning, academic skills,and/or visuospatial processing. To pursue this, the EF training needs to be integrated into the complex and multidisciplinary care context promoting innovative intervention methodologies based on scientific evidence. Recent researches and clinical practice, carried out in our Institute, supports the effectiveness of innovative interventions on EF using new technologies in typical and atypical development, such as Self-adapting web based softwares, Game-based tools or Educational Robotics. Literature suggests these technologies allow to promote timely intervention within a user-friendly context, while respecting the key criteria of evidence-based neuropsychological rehabilitation, both reducing hospitalisation times and supporting interest and motivation for participation. The primary aim of this study is to evaluate the applicability of technological intervention integrated with psychomotor activities to promote EF and then secondary to measure the effect on the functional profile of children with CP, including motor planning, visuo-spatial processing and learning skills, evaluating both short-term (T2) and long-term changes (T3). conditions: Executive Functions in Cerebral Palsy studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: Self-adaption web-based software for the rehabilitation of EF and visuo-spatial abilities name: Tele-rehabilitation of EF and specific cognitive processes underlying academic skills name: Game-based tools for the rehabilitation of EF and motor planning measure: changes in score of inhibition subtest at the NEPSY-II measure: changes in score of the sustained attention subtest at the Leiter-3 measure: changes in score of Developmental Test of Visual-Motor Integration (VMI) measure: changes in score of MOXO-continuous performance test measure: changes in score of Corsi block-tapping subtest at the BVS-corsi measure: changes in score of Behaviour Rating Inventory of Executive Function (BRIEF-P/2) for parents measure: changes in score of RAN (rapid automatized naming) subtest at the rapid automatized naming and visual search of colours, figures and numbers test. measure: changes in score of reading and text comprehension task at the ALCE measure: changes in score of reading and writing task at the DDE-2 measure: changes in score of digit span forwards and backwards subtest at the BVN 5-11 and BVN 12-18 measure: changes in score of Go/No-Go and N-back 1 subtest at the teleFE measure: changes in score of verbal fluency subtest at the NEPSY-II measure: changes in score of Test of Visual Perception and Visuo-motor Integration (TPV) measure: changes in score of Praxic and Motor Coordination Skills-2nd Edition (APCM-2) measure: changes in score of Movement Assessment Battery for Children - Second Edition (Movement ABC-2) measure: changes in score of Synthetic scale for the evaluation of writing in developmental age (BHK test) sex: ALL minimumAge: 5 Years maximumAge: 13 Years stdAges: CHILD facility: IRCCS Fondazione Stella Maris city: Pisa zip: 56128 country: Italy lat: 43.70853 lon: 10.4036 hasResults: False
<\|newrecord\|> nctId: NCT06288958 id: Fondazione Stella Maris briefTitle: Quality of Life in Children With Cerebral Palsy overallStatus: COMPLETED date: 2019-04-01 date: 2020-12-31 date: 2021-12-31 date: 2024-03-01 date: 2024-03-01 name: IRCCS Fondazione Stella Maris class: OTHER briefSummary: Cerebral Palsy (CP) is an umbrella term that defines a group of permanent disorders of movement and posture, happening during the developing foetal or infant brain. In addition to the main motor symptoms, other clinical disturbances are associated. CP represents a clinical condition with an impact in Quality Of Life (QOL) and social participation, as reported in different countries. QOL is a multidimensional construct defined as "an individual's perception of their position in life in the context of the culture and value systems in which they live and in relation to their goals, expectations, standards, and concerns" (WHOQOL, 1998).
In order to best capture the peculiarities of CP, specific questionnaires were carried out to analyse the QOL in this clinical population. The Cerebral Palsy Quality of Life Questionnaire for Children (CP QOL-Child) is an internationally recognized CP-specific instrument based on the International Classification of Functioning, Disability and Health (ICF) framework. Many studies have used this instrument, showing a lower QOL in children with CP compared to their typical developing peers. In literature, several studies have shown that children with CP are at risk of experiencing activity limitations and participation restriction and which can potentially affect their QOL. Participation in daily-life activities, defined as a person's "involvement in a life situation," and participation restriction, characterised as "problems an individual may experience in involvement in life situations" (ICF, World Health Organization, 2001). Studies aimed at describing participation in daily-life activities in CP have consistently found lower frequencies and fewer activities in children and adolescents with CP. In order to gain an overall picture of the QOL and participation of children and adolescents with CP, several studies underline the importance of analysing other background factors, such as motor and cognitive functioning, pain perception, and individual characteristics.
The present study aims to deeper understand the perception of QOL and social participation in a group of Italian children with CP, as reported by their parents, using two commonly used questionnaires in the CP population (CP-QOL and PEM-CY). In addition, this study aims to explore the roles of specific clinical variables, such as motor function and cognitive level, on parental perceptions of QOL, in the development of QOL and participation. conditions: Unilateral and Bilateral Cerebral Palsy studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: RETROSPECTIVE count: 80 type: ACTUAL name: Quality of Life and social participation in Italian children with CP measure: Score of CP-QOL Child questionnaire measure: Score of PEM-CY questionnaire measure: Scores of Wechsler Intelligence scales sex: ALL minimumAge: 4 Years maximumAge: 12 Years stdAges: CHILD facility: IRCCS Fondazione Stella Maris city: Pisa zip: 56128 country: Italy lat: 43.70853 lon: 10.4036 hasResults: False
<\|newrecord\|> nctId: NCT06288945 id: Dry eye syndrome briefTitle: Effect of an Educational Program on Health-related Outcomes of Patients With Dry Eye Syndrome overallStatus: COMPLETED date: 2023-01-15 date: 2023-09-14 date: 2023-09-14 date: 2024-03-01 date: 2024-03-01 name: Alexandria University class: OTHER briefSummary: Dry eye syndrome (DES) is a widespread ocular disease affecting the general population. It is a complex disorder affecting the surface of the eye, marked by an imbalance in the tear film and ocular symptoms. Therefore this study was done to determine the effect of an educational program on health-related outcomes of patients with DES including the severity of symptoms related to DES and their influence on visual-related functions conditions: Dry Eye Syndrome studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 60 type: ACTUAL name: Educational Program measure: ocular irritation symptoms associated with Dry eye syndrome and their effect on functions related to vision sex: ALL minimumAge: 20 Years maximumAge: 60 Years stdAges: ADULT facility: Faculty of Nursing, Alexandria university city: Alexandria country: Egypt lat: 31.21564 lon: 29.95527 hasResults: False
<\|newrecord\|> nctId: NCT06288932 id: NIBD/IRB-263/08-2023 briefTitle: Outcome Study of Conventional Steroids vs. Steroids Combined With Mycopehnolate in Newly Diagnosed Immune Thrombocytopenia Purpura. overallStatus: RECRUITING date: 2024-02 date: 2024-05 date: 2025-01 date: 2024-03-01 date: 2024-03-01 name: National Institute of Blood and Marrow Transplant (NIBMT), Pakistan class: OTHER_GOV briefSummary: Immune thrombocytopenia Purpura (ITP) is an autoimmune condition delineated by humoral as well as cell mediated immune response against thrombocyte surface proteins GPIIb/IIIa receptors, affecting primary homeostasis leading to mucocutaneous bleeding.ITP is characterized by platelet count \<100 x 109/L. The conventional line of treatment for newly diagnosed ITP is steroids but significant disadvantages have been associated with long term use and a high risk of relapse when reducing the dose. The addition of MMF to the first line treatment of ITP resulted in substantial response and a lower risk of refractory ITP with decreased financial burden and improved outcome. conditions: Immune Thrombocytopenia Purpura studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The study will comprise the newly diagnosed patients of Immune thrombocytopenia purpura aged 5-60 year. Patients will be included in this trial, with a 1:1 ratio among the two group patients will be in each group. One group will receive steroids alone and the other will receive steroids and MMF. primaryPurpose: TREATMENT masking: NONE count: 104 type: ESTIMATED name: Mycophenolate Mofetil (MMF) Treatment measure: Platelet count monitoring measure: Assessment of Health-Related Quality of Life questionnaire measure: Incidence of adverse events sex: ALL minimumAge: 5 Years maximumAge: 60 Years stdAges: CHILD stdAges: ADULT facility: National Institute of Blood Diseases and Bone Marrow Transplantation status: RECRUITING city: Karachi state: Sindh zip: 75300 country: Pakistan lat: 24.8608 lon: 67.0104 hasResults: False
<\|newrecord\|> nctId: NCT06288919 id: 2023-IMPLHYGIENE briefTitle: Erythritol vs Ultrasonic Scaler Prophylaxis Systems on Dental Implants With Crowns Made by Different Materials overallStatus: ENROLLING_BY_INVITATION date: 2024-03-01 date: 2026-04-01 date: 2026-04-10 date: 2024-03-01 date: 2024-04-26 name: University of Pavia class: OTHER briefSummary: The aim of the study is to assess which prophylaxis methods is the most suitable for peri-implant hygiene between erythritol and ultrasonic scaler with peek inserts.
A randomized clinical trial will be conducted on the patient. Patients will be randomly divided into two groups:
* Erythritol group: erythritol with a particle size of \~14 µm will be used for 5 seconds (AIRFLOW® PLUS EMS)
* Ultrasonic scaler group: a piezoelectric handpiece with peek inserts (Mini Piezon EMS; PI EMS) will be used.
Different subgroups will be defined according to the material of the dental crown of the related implant.
The oral hygiene session will be carried out every 6 months (2-years follow-up; 6 sessions), after instruction and motivation of the patient, completion of the clinical chart with the recording of the Probing Depth (evaluation in mm of the peri-implant sulcus taken by a periodontal probe; 4 surfaces of the gingival margin are detected: vestibular, palatal/lingual, mesial, distal), Bleeding on Probing and Plaque Index. conditions: Dental Implant Failed conditions: Peri-implant Mucositis conditions: Peri-Implantitis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Erythritol prophylactic powders name: Ultrasonic scaler with peek inserts measure: Probing Depth (PD) measure: Bleeding on Probing (BoP) measure: Plaque Index sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia city: Pavia state: Lombardy zip: 27100 country: Italy lat: 45.19205 lon: 9.15917 hasResults: False
<\|newrecord\|> nctId: NCT06288906 id: ASTER Study briefTitle: Acute and Subacute Iliofemoral and/or Caval Deep Vein Thrombosis: Evaluation of Mechanical Thrombectomy Systems acronym: ASTER overallStatus: NOT_YET_RECRUITING date: 2024-03-30 date: 2027-03 date: 2027-12 date: 2024-03-01 date: 2024-03-04 name: IRCCS San Raffaele class: OTHER briefSummary: This is a physician-initiated, observational, monocentric, retrospective and prospective Study. The study is intended to assess the feasibility of mechanical thrombectomy of caval and iliofemoral veins according to normal clinical practice in adult patients with symptomatic acute or subacute ileofemoral or caval deep vein thrombosis objectively diagnosed with CT scan imaging. conditions: Thrombosis, Venous studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 50 type: ESTIMATED name: mechanical thrombectomy of caval and iliofemoral veins measure: Rate of Technical success measure: Number of Participants presenting Bleeding sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: San Raffaele Hospital city: Milano zip: 20132 country: Italy lat: 45.46427 lon: 9.18951 hasResults: False
<\|newrecord\|> nctId: NCT06288893 id: DEU-2001 briefTitle: SHEN211 Tablets for the Treatment of Mild and Moderate Novel Corona Virus Infections (COVID-19) overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-08-01 date: 2025-01-01 date: 2024-03-01 date: 2024-03-04 name: JKT Biopharma Co., Ltd. class: INDUSTRY briefSummary: Randomized, double-blind, placebo-controlled, multicenter phase II clinical study of SHEN211 tablets conditions: COVID-19 studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized 2:1 to experimental and placebo arms primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: double-blind whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: SHEN211 Tablets name: Placebo for SHEN211 Tablets measure: Change from baseline in SARS-CoV-2 viral load at each time point measure: Time of recovery measure: Time to response measure: Time to negative measure: Percentage of subjects with disappearance of clinical symptoms measure: Change in COVID-19 symptom score measure: Ct value change from baseline measure: Change from baseline in chest CT scan (optional) measure: Percentage of Subjects Progressed measure: Percent of Subjects Who Died measure: Safety Assessment Results sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Shenzhen Third People 's Hospital city: Shenzhen state: Guangdong zip: 518112 country: China name: Hongzhou Lu, ph.D role: CONTACT phone: 0755-61232898 email: luhongzhou@fudan.edu.cn name: Ximin Meng role: CONTACT phone: 0755-61222333 phoneExt: 16565 email: szywjd2015@163.com name: Hongzhou Lu, ph.D role: PRINCIPAL_INVESTIGATOR lat: 22.54554 lon: 114.0683 hasResults: False
<\|newrecord\|> nctId: NCT06288880 id: kilis_4 briefTitle: Impact of Earthquake Trauma on Nurses' Compassion Fatigue: A Study From Kahramanmaraş, Turkey overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-04-01 date: 2024-05-01 date: 2024-03-01 date: 2024-03-01 name: Kilis 7 Aralik University class: OTHER name: Hasan Kalyoncu University briefSummary: This study investigates the impact of earthquake trauma on compassion fatigue among nurses working in emergency services following the devastating earthquakes on 6 February 2023, in Kahramanmaraş, Turkey. These earthquakes, with magnitudes of approximately 7.7 and 7.6, affected 11 provinces and resulted in over 50,000 deaths and 100,000 injuries, placing emergency service nurses at the forefront of dealing with the aftermath and trauma. The concept of compassion fatigue, characterised by a reduced capacity for empathy after repeated exposure to traumatic events, is a significant concern for nurses who have been directly involved in the care of earthquake victims. This study aims to explore the extent of earthquake trauma and compassion fatigue among these nurses, examining the relationship between these two conditions and their long-term effects. Given the limited research on post-traumatic stress disorder and compassion fatigue among emergency service nurses, this study seeks to contribute valuable insights into the psychological impacts of disaster response on healthcare professionals. The hypotheses tested aim to better understand the risks and psychological burdens faced by nurses in the wake of such natural disasters. conditions: Earthquake conditions: Compassion Fatigue studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 250 type: ESTIMATED measure: Section 1: Demographic Information Form measure: Section 2: Post-Earthquake Trauma Level Determination Scale measure: Section 3: Compassion Fatigue Short Scale sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Islam Elagöz city: Kilis zip: 79100 country: Turkey name: islam elagöz role: CONTACT name: Aynur koyuncu role: CONTACT lat: 36.71611 lon: 37.115 hasResults: False
<\|newrecord\|> nctId: NCT06288867 id: FMASU MD28/2024 briefTitle: A 12 Months Prospective Study Comparing Functional Outcome Scores in Hip Arthroscopic Labral Repair Versus Debridement overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-09-01 date: 2025-12-01 date: 2024-03-01 date: 2024-03-18 name: Ain Shams University class: OTHER briefSummary: This study aims to address hip labral tears and compare between arthroscopic labral repair versus debridement. conditions: Hip Injuries conditions: Acetabular Labral Tear conditions: Femoro Acetabular Impingement studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 20 type: ESTIMATED name: Arthroscopic Labral Repair name: Arthroscopic Labral Debridement measure: Change from baseline in Hip Function, as measured by Hip Outcome Score (HOS) measure: Change from baseline in Hip Function, as measured by Harris Hip Score (HHS) measure: Change from baseline in Pain, as measured by the Visual Analogue Scale (VAS) sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Ain Shams University city: Cairo country: Egypt name: Karim A Salem, MD role: CONTACT phone: 1000017388 phoneExt: +20 email: karimatefsalem@gmail.com lat: 30.06263 lon: 31.24967 hasResults: False
<\|newrecord\|> nctId: NCT06288854 id: 66222 briefTitle: Efficacy of Olanzapine on Weight Gain in Advanced Gynecologic Cancer With Paclitaxel and Carboplatin: a Double Blind, Placebo-controlled Randomized Trial overallStatus: NOT_YET_RECRUITING date: 2024-04-03 date: 2025-03-31 date: 2025-06-30 date: 2024-03-01 date: 2024-03-12 name: Rajavithi Hospital class: OTHER_GOV briefSummary: * Efficacy of olanzapine on weight gain in advanced stage gynecologic cancer
* Proprotion of pateints in advanced stage gynecologic cancer who recieving paclitaxel and carboplatin chemotherapy gain weight on olanzapine or placebo conditions: Weight Gain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: olanzapine vs placebo primaryPurpose: PREVENTION masking: SINGLE whoMasked: PARTICIPANT count: 48 type: ESTIMATED name: weight gain each group measure: Efficacy of olanzapine on weight gain in advanzed stage gynecologic cancer recieving paclitexal and carboplatin chemotherapy sex: FEMALE minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06288841 id: TJMZ2023-008 briefTitle: Efficacy and Safety of Liposomal Bupivacaine Under ERAS Concept for Postoperative Analgesia of Ultrasound-Guided QLB in Gynecologic Laparoscopic Patients: A Randomized, Single-blind, Active-Controlled Clinical Study overallStatus: RECRUITING date: 2023-11-30 date: 2024-07-31 date: 2024-11-29 date: 2024-03-01 date: 2024-03-01 name: Tianjin Medical University General Hospital class: OTHER briefSummary: With the development of the concept of comfortable medicine and enhanced recovery surgery (ERAS), optimizing the perioperative management of patients, reducing surgical stress, and reducing postoperative pain can effectively reduce perioperative complications and achieve the purpose of accelerating recovery. As an important part of ERAS, multimodal analgesia is the core concept of perioperative analgesia management. As a kind of perioperative multimodal analgesia, quadratus lumbar muscle block (QLB) is a type of local anesthetic drug injected around the quadratus lumbar muscle to reduce or eliminate abdominal wall pain and visceral pain after abdominal surgery. QLB has been used successfully for pain control after laparoscopic and open surgery, reducing perioperative opioid use and improving prognosis-related measures such as PONV and length of hospital stay. Bupivacaine liposomes use DepoFoam technology to encapsulate the drug in polycystic liposomes, which can prolong the release time of bupivacaine due to the different rupture times of different vesicles, and the postoperative analgesia can be up to 72 hours. In this project, patients who undergo elective laparoscopic uterine and double adnexectomy were selected to be injected with lipososomes of bupivacaine at different concentrations under ultrasound guidance of bilateral posterior QLB before anesthesia induction, and the effect of liposomal bupivacaine on postoperative pain was investigated by evaluating the postoperative pain and incidence of adverse events. This study will greatly promote the clinical promotion and application of bupivacaine liposome, improve the postoperative comfort and satisfaction of patients, and accelerate the postoperative recovery of patients. conditions: Pharmacological Action studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 200 type: ESTIMATED name: Ropivacaine injection name: Bupivacaine liposome measure: NRS pain score within 72 hours after surgery sex: FEMALE minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tianjin Medical University General Hospital status: RECRUITING city: Tianjin state: Tianjin zip: 300052 country: China name: Ning Luo role: CONTACT phone: 13622098703 email: ningluo1996@163.com lat: 39.14222 lon: 117.17667 hasResults: False
<\|newrecord\|> nctId: NCT06288828 id: IRB0569/66 briefTitle: The Efficacy of Aerobic Exercise Training on Autonomic Nervous System and Endothelial Function in Patients With Compensated Cirrhosis overallStatus: NOT_YET_RECRUITING date: 2024-03-05 date: 2024-08-01 date: 2025-12-31 date: 2024-03-01 date: 2024-03-01 name: King Chulalongkorn Memorial Hospital class: OTHER name: Chulalongkorn University briefSummary: The goal of this clinical trial is to explore the impact of a 16-week aerobic exercise regimen on the autonomic nervous system and endothelial function in patients with compensated cirrhosis who maintain sedentary lifestyles. The primary research question is:
1) What effect does 16 weeks of aerobic exercise have on changes in the autonomic nervous system and endothelial function in cirrhotic patients?
Additionally, the secondary research questions are:
1. How does a 16-week aerobic exercise program influence changes in muscle mass, muscle strength, and physical performance in cirrhotic patients?
2. Is there a correlation between muscle mass and parameters of the autonomic nervous system in cirrhotic patients?
Participants in the intervention group will undergo 150 minutes of moderate aerobic exercise per week for 16 weeks, accompanied by a personalized nutritional plan (1.2 grams of protein per kilogram of ideal body weight per day and a calorie intake of 35 kilocalories per kilogram of ideal body weight per day). The control group will solely receive nutritional guidance and maintain their sedentary lifestyle. The researchers will compare outcomes between these two groups. conditions: Cirrhosis conditions: Aerobic Exercises conditions: Lifestyle Modification conditions: Endothelial Function conditions: Autonomic Nervous System conditions: Autonomic Dysfunction conditions: Heart Rate Variability conditions: Flow Mediated Dilation conditions: Sarcopenia conditions: Physical Activity conditions: Physical Functional Performance studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: INVESTIGATOR count: 70 type: ESTIMATED name: Aerobic exercise name: Nutrition consultant measure: Autonomic function test: Heart rate variability (HRV) measure: Endothelial function test: Flow mediated dilation (FMD) in % FMD change measure: Physical function measure: Muscle mass change measure: Muscle strength change sex: ALL minimumAge: 45 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Faculty of medicine, King Chulalongkorn Memorial Hospital city: Bangkok zip: 10330 country: Thailand lat: 13.75398 lon: 100.50144 hasResults: False
<\|newrecord\|> nctId: NCT06288815 id: TUH oral fluid TKA briefTitle: Oral Fluid vs IV Fluid After Primary TKA overallStatus: RECRUITING date: 2024-01-10 date: 2024-12 date: 2025-06 date: 2024-03-01 date: 2024-03-04 name: Thammasat University Hospital class: OTHER briefSummary: The goal of this study is to compared efficacy of oral fluid and intravenous fluid after primary unilateral total knee arthroplasty.
The main question it aims to answer is:
Does oral fluid replacement after primary unilateral total knee arthroplasty provide a patient recover faster than intravenous fluids replacement? conditions: Osteoarthritis, Knee conditions: Total Knee Arthroplasty conditions: Oral Fluid Replacement studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 130 type: ESTIMATED name: Oral fluid name: IV fluid measure: Time to stand and walk measure: Time up and go measure: Incidence of oliguria measure: Incidence of nausea/vomiting measure: Urine specific gravity measure: the levels of certain electrolytes measure: the levels of creatinine measure: the levels of blood urea nitrogen (BUN). measure: Complications sex: ALL minimumAge: 40 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Thammasat University status: RECRUITING city: Khlong Luang state: Pathum Thani zip: 12120 country: Thailand name: Yot Tanariyakul, M.D. role: CONTACT phone: 663930257 email: y.tanariyakul@gmail.com name: Nattapol Tammachote, M.D. role: PRINCIPAL_INVESTIGATOR lat: 14.06467 lon: 100.64578 hasResults: False
<\|newrecord\|> nctId: NCT06288802 id: 04-2023-200647 briefTitle: Study of Wilms Tumors Among Patients of Shefa Al-Orman Children Cancer Hospital overallStatus: RECRUITING date: 2020-06-15 date: 2024-06 date: 2024-12 date: 2024-03-01 date: 2024-03-01 name: South Egypt Cancer Institute class: OTHER name: Shefa Al-orman Children Cancer Hospital name: Assiut University briefSummary: The goal of this cross sectional observational study is to determine the percentage of Wilms tumors among pediatric cancers at Shefa Al-Orman Children Cancer Hospital from june 2020 to june 2024,to study the outcome of patients with Wilms tumor treated according to SIOP Umbrella protocol during the study period and to study the treatment related complications during therapy according to common terminology criteria of adverse events version 5.0 (CTCAE Version 5.0). conditions: Wilms Tumor studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 50 type: ESTIMATED measure: Overall-survival (OS) measure: Event-free survival (EFS) sex: ALL maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Shefa Al-orman Children Cancer Hospital status: RECRUITING city: Luxor country: Egypt name: Mahmoud Elzembely, MD role: CONTACT phone: +201146703107 email: elzimbily@aun.edu.eg lat: 25.69893 lon: 32.6421 hasResults: False
<\|newrecord\|> nctId: NCT06288789 id: SFI-TR briefTitle: Turkish Validity and Reliability of the Social Frailty Index overallStatus: COMPLETED date: 2024-02-25 date: 2024-03-20 date: 2024-03-30 date: 2024-03-01 date: 2024-04-25 name: Pamukkale University class: OTHER briefSummary: The aim was to examine the validity and reliability of the Social Frailty Index in Turkish among older adults. 65 years and above older adults will be included included in the study. Older adults who agree to participate in the study will first be administered the Hodkinson Mental Test. Those who score 6 points and above will be included in the study. To evaluate the validity of the \"Social Frailty Index\", Social Inclusion Scale, Older people\'s quality of life-brief (OPQOL-brief) and Lubben Social Network Scale will be applied to the participants. To determine the reliability of the \"Social Frailty Index\", older adults who do not receive any treatment will be tested and re-tested at one-week intervals. conditions: Elderly conditions: Frailty conditions: Quality of Life studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 186 type: ACTUAL name: Social Frailty Index measure: Social Frailty Index measure: Socıal Inclusıon Scale measure: Older people's quality of life-brief (OPQOL-brief) measure: Lubben Social Network Scale sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: Elif Gur Kabul city: Usak state: Merkez zip: 64200 country: Turkey lat: 38.67351 lon: 29.4058 hasResults: False
<\|newrecord\|> nctId: NCT06288776 id: SOD/ERB/2023/22-04 briefTitle: Efficacy of Azadirachta Indica Based Herbal Mouthwash in Treating the Tooth Hypersensitivity overallStatus: COMPLETED date: 2023-02-01 date: 2023-04-30 date: 2023-04-30 date: 2024-03-01 date: 2024-03-01 name: Pakistan Institute of Medical Sciences class: OTHER_GOV briefSummary: Type of study: Single-blinded clinical trial to evaluate the effectiveness of Azadirachta indica based Herbal mouthwash to treat the tooth sensitivity in patients.
Participants aged 20 years and above having Gingival Index score 3 will be included in the study. Their tooth sensitivity will be checked initially and then they will be given Herbal based mouthwash for 3 months. Again, their tooth sensitivity shall be checked after 3 months. conditions: Tooth Sensitivity studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: In this study, participants will be selected by consecutive non-random sampling technique. primaryPurpose: TREATMENT masking: NONE maskingDescription: Single-blinded study where participant will be masked. count: 120 type: ACTUAL name: Herbal based mouthwash measure: Toothsensitivity declination with herbal based mouthwash sex: ALL minimumAge: 20 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Afsheen Mansoor city: Islamabad zip: 44080 country: Pakistan lat: 33.72148 lon: 73.04329 hasResults: False
<\|newrecord\|> nctId: NCT06288763 id: SC220192 briefTitle: Nerve Transfer to Improve Function in High Level Tetraplegia overallStatus: RECRUITING date: 2024-02-05 date: 2028-03-01 date: 2028-12-31 date: 2024-03-01 date: 2024-04-02 name: Washington University School of Medicine class: OTHER name: University of Michigan name: University of Calgary name: The Methodist Hospital Research Institute name: University of Pennsylvania name: University of Utah name: Stanford University name: University of Miami name: Johns Hopkins University name: University of Alberta briefSummary: The goal of this observational study is to determine if nerve transfer surgeries improve upper extremity function and quality of life in patients with a high level cervical spinal cord injury.
Participants will:
* undergo standard of care pre- and post-op testing and study exams
* complete pre- and post-questionnaires
* undergo standard of care nerve transfer surgeries
* follow-up with surgeon at 6/12/18/24/36 and potentially at 48 months
* attend therapy at local therapist for up to 2 years postop. conditions: Cervical Spinal Cord Injury conditions: Tetraplegia studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 30 type: ESTIMATED measure: Elbow Dynamometry measure: Spinal Cord Independence Measure measure: Motor strength in medical research council grade (MRC) measure: Electrodiagnosis (Nerve Conduction Study and Electromyography measure: Canadian Outcomes Performance Measure (COPM) measure: Capabilities of Upper Extremity Questionnaire (CUE-Q) measure: Modified Ashworth Scale (MAS) measure: Spinal Cord Injury Quality of LIfe Questionnaire measure: International SCI Pain Basic Dataset (ISCIPBDS) sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Stanford University status: NOT_YET_RECRUITING city: Stanford state: California zip: 94305 country: United States name: Adrian Valladarez role: CONTACT phone: 650-381-4257 email: adrian98@stanford.edu name: Anthony Bet role: CONTACT phone: 650-683-5823 email: abet0915@stanford.edu name: Thomas J Wilson, MD role: PRINCIPAL_INVESTIGATOR lat: 37.42411 lon: -122.16608 facility: University of Miami status: RECRUITING city: Miami state: Florida zip: 33136 country: United States name: George Jimsheleishvili, MD role: CONTACT phone: 305-243-4781 email: gxi150@med.miami.edu name: Patricia Graham role: CONTACT phone: 305-243-5119 email: pgraham1@med.miami.edu name: Stephen S Burks, MD role: PRINCIPAL_INVESTIGATOR name: Allan Levi, MD role: SUB_INVESTIGATOR lat: 25.77427 lon: -80.19366 facility: Johns Hopkins University status: NOT_YET_RECRUITING city: Baltimore state: Maryland zip: 21287 country: United States name: Aston King role: CONTACT phone: 667-306-8862 email: aking64@jhu.edu name: Bronwyn Slobogean role: CONTACT email: bslobog1@jhmi.edu name: Sami Tuffaha, MD role: PRINCIPAL_INVESTIGATOR name: Allan Belzberg, MD role: SUB_INVESTIGATOR lat: 39.29038 lon: -76.61219 facility: University of Michigan status: RECRUITING city: Ann Arbor state: Michigan zip: 48109 country: United States name: Savannah Solomon role: CONTACT phone: 734-936-7010 email: ssavanna@med.umich.edu name: Yamaan Saadeh, MD role: PRINCIPAL_INVESTIGATOR lat: 42.27756 lon: -83.74088 facility: Washington University in St. Louis status: RECRUITING city: Saint Louis state: Missouri zip: 63110 country: United States name: Linda Koester role: CONTACT phone: 314-362-7368 email: koesterl@wustl.edu name: Wilson Z. Ray, MD role: PRINCIPAL_INVESTIGATOR lat: 38.62727 lon: -90.19789 facility: University of Pennsylvania status: RECRUITING city: Philadelphia state: Pennsylvania zip: 19104 country: United States name: Lora Assi role: CONTACT phone: 267-254-4745 email: NCRDNeuroICU@uphs.upenn.edu name: Leah Coghlan role: CONTACT phone: 215-341-5864 email: NCRDNeuroICU@uphs.upenn.edu name: Eric Zager, MD role: PRINCIPAL_INVESTIGATOR lat: 39.95233 lon: -75.16379 facility: Houston Methodist status: RECRUITING city: Houston state: Texas zip: 77030 country: United States name: Amber Behne role: CONTACT phone: 346-238-6424 email: abehne@houstonmethodist.org name: Sergio Ibarra Cortez role: CONTACT phone: 346-238-2494 email: shibarracortez@houstonmethodist.org name: Amir Faraji, MD role: PRINCIPAL_INVESTIGATOR lat: 29.76328 lon: -95.36327 facility: University of Utah status: NOT_YET_RECRUITING city: Salt Lake City state: Utah zip: 84132 country: United States name: Kirstianna Lombardi role: CONTACT phone: 801-585-9821 email: kirstianna.lombardi@utah.edu name: Douglas Gibula role: CONTACT email: douglas.gibula@hsc.utah.edu name: Mark Mahan, MD role: PRINCIPAL_INVESTIGATOR lat: 40.76078 lon: -111.89105 facility: University of Calgary - Alberta Health Services status: NOT_YET_RECRUITING city: Calgary state: Alberta zip: T2N 2T9 country: Canada name: Ish Bains role: CONTACT phone: 403-944-4334 email: ish.bains@albertahealthservices.ca name: Rajiv Midha, MD role: PRINCIPAL_INVESTIGATOR lat: 51.05011 lon: -114.08529 facility: University of Alberta status: NOT_YET_RECRUITING city: Edmonton state: Alberta zip: T6G 2E1 country: Canada name: Mith Rajshekar, PhD role: CONTACT email: rajsheka@ualberta.ca name: Andrew Jack, MD role: PRINCIPAL_INVESTIGATOR lat: 53.55014 lon: -113.46871 hasResults: False
<\|newrecord\|> nctId: NCT06288750 id: sdllycyyqx001 briefTitle: Protective Effect of Indocyanine Green Fluorescence Imaging Technology on Parathyroid Glands During Total Thyroidectomy overallStatus: RECRUITING date: 2024-02-01 date: 2025-06-01 date: 2025-06-30 date: 2024-03-01 date: 2024-03-05 name: Shandong Linglong Yingcheng Hospital class: NETWORK briefSummary: Accurate identification and evaluation of the parathyroid glands (PGs) intraoperatively is critical to reduce the incidence of postoperative hypoparathyroidism after total thyroidectomy. Near-infrared fluorescence imaging (NIFI), including the autofluorescence (AF) and indocyanine green fluorescence (ICGF) imaging, is a promising technique to protect PGs. This study aimed to assess whether the combined use of AF and ICGF could reduce the incidence of postoperative hypoparathyroidism and improve the identification and evaluation of PGs during total thyroidectomy. conditions: Total Thyroidectomy conditions: Parathyroid Function Low Adverse Event conditions: Parathyroid Glands--Diseases conditions: Indocyanine Green studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: PREVENTION masking: DOUBLE whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 200 type: ESTIMATED name: Indocyanine Green name: No indocyanine green measure: Identification of parathyroid glands (PGs) by NIR/ICG camera detected high-contrast measure: Central lymph node dissetion (CLND) sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Shandong Linglong Yingcheng Hospital status: RECRUITING city: Yantai state: Shandong zip: 264000 country: China name: Xuan Qiu, MD role: CONTACT phone: 8618354280081 email: qiuxuan100@163.com name: Ni Wang, MD role: CONTACT phone: 8618705353551 email: wangni1989@163.com lat: 37.47649 lon: 121.44081 hasResults: False
<\|newrecord\|> nctId: NCT06288737 id: 54335073 briefTitle: Assessing Patient Engagement in Keratoconus Clinical Research overallStatus: NOT_YET_RECRUITING date: 2025-03 date: 2026-03 date: 2027-03 date: 2024-03-01 date: 2024-03-01 name: Power Life Sciences Inc. class: INDUSTRY briefSummary: This study aims to investigate the influences behind patient choices regarding involvement, discontinuation, or re-engagement in keratoconus clinical trials. Uncovering these factors is essential to enhance the relevance and efficacy of future research endeavors.
In essence, this trial aims to deepen understanding of the factors influencing participation in keratoconus clinical trials. Elevating participation rates could expedite the development of innovative treatments for this challenging condition. conditions: Keratoconus studyType: OBSERVATIONAL observationalModel: CASE_CROSSOVER timePerspective: PROSPECTIVE count: 500 type: ESTIMATED measure: Rate of patients who decide to join in a keratoconus clinical trial measure: Number of keratoconus patients who remain in clinical trial until completion sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Power Life Sciences city: San Francisco state: California zip: 94107 country: United States name: Michael B Gill role: CONTACT phone: 415-900-4227 email: https://www.withpower.com/contact-us@withpower.com lat: 37.77493 lon: -122.41942 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2024-02-23 uploadDate: 2024-02-23T11:13 filename: ICF_000.pdf size: 73995 hasResults: False
<\|newrecord\|> nctId: NCT06288724 id: NatIntensive briefTitle: MOdifiable facTors to Improve VentilAtion ThErapy in ICU acronym: MOTIVATE-ICU overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-09 date: 2024-09 date: 2024-03-01 date: 2024-03-01 name: Nat Intensive Care Surveillance - MORU class: OTHER name: D'Or Institute for Research and Education name: University of Oxford name: Wellcome Trust name: Makerere University briefSummary: ABSTRACT Introduction: Invasively ventilated patients in low and middle-income countries (LMICs) experience significantly higher mortality compared to those in High income countries (HICs). Direct application of HIC strategies to LMICs maybe ineffective due to context-specific challenges. This study aims to leverage the Intensive Care Registry of Uganda (ICRU) to identify ICU structural and process-related modifiable factors that impact patient outcomes in a low income country.
Methods: The MOTIVATE-ICU is a prospective multicentre observational study in invasively ventilated patients. It involves a registry-embedded component examining patient- and process-related factors and a cross-sectional survey on ICU organizational structures. Inclusion criteria encompass patients aged ≥ 15 years undergoing IMV in Ugandan ICUs. Primary outcomes are ICU mortality, ICU length of stay (LOS), and duration of ventilation. Secondary outcomes include ventilator-associated complications, non-pulmonary organ support. tTracheostomy outcomes will be explored in a pre-planned substudy. Factors potentially associated with outcomes will be categorized into two groups; non-modifiable factors and potentially modifiable. Non-modifiable factors will include patient-related factors like age, comorbidities and illness severity; potentially modifiable factors include processes of care (e.g. sedation levels) and ICU organizational structure (e.g. staffing patterns). Multilevel multivariable logistic regression will be utilized to study associations, with both patient and ICU level fixed effects considered.
Ethics and Dissemination: Given its observational nature, this study seeks a waiver for patient individual informed consent. Data anonymization ensures patient privacy. Following the principles of the Declaration of Helsinki, relevant ethical approvals will be acquired. Study findings will be disseminated through conferences and peer-reviewed journals. conditions: Critical Illness conditions: Invasive Mechanical Ventilation conditions: ICU Mortality conditions: Developing Countries conditions: Risk Factors studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 625 type: ESTIMATED measure: ICU mortality measure: ICU Length of Stay measure: Duration of mechanical ventilation measure: Duration of non-pulmonary organ support measure: ICU-Free days measure: Ventilator-free days measure: Ventilator-associated Pneumonia measure: Tracheobronchitis measure: Non-infectious Pulmonary complication measure: Readmission measure: Unplanned extubations measure: Tracheostomy related outcomes sex: ALL minimumAge: 15 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06288711 id: CHRBSS #STUDY00002538 id: R01DA057308 type: NIH link: https://reporter.nih.gov/quickSearch/R01DA057308 briefTitle: Novel Telemedicine-Delivered Prolonged Exposure Therapy for Treating PTSD in Individuals With OUD overallStatus: RECRUITING date: 2024-04-30 date: 2027-08-31 date: 2027-11-30 date: 2024-03-01 date: 2024-04-23 name: University of Vermont class: OTHER name: National Institute on Drug Abuse (NIDA) briefSummary: Among individuals with opioid use disorder (OUD), posttraumatic stress disorder (PTSD) presents a significant clinical challenge. The prevalence of PTSD is substantially higher in individuals with OUD than in the general population, with nearly 90% reporting lifetime trauma exposure and 33% meeting diagnostic criteria for PTSD. The primary objective of this study is to evaluate the efficacy of a novel telemedicine-delivered prolonged exposure therapy protocol for improving PE attendance and reducing PTSD symptom severity in individuals with concurrent PTSD and OUD. conditions: Opioid Use Disorder conditions: Posttraumatic Stress Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 135 type: ESTIMATED name: Prolonged exposure therapy name: Financial incentives name: Treatment as usual measure: Prolonged exposure therapy session attendance measure: Prolonged exposure therapy completion measure: Change in posttraumatic stress disorder symptom severity - clinician rated measure: Change in non-prescribed drug use - objective measure: Change in non-prescribed drug use - self-reported measure: Change in opioid craving measure: Medications for opioid use disorder treatment retention measure: Prolonged exposure therapy acceptability measure: Satisfaction with prolonged exposure therapy delivered via telemedicine measure: Prolonged exposure therapy homework adherence measure: Change in posttraumatic stress disorder symptom severity - self-reported sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Vemont status: RECRUITING city: Burlington state: Vermont zip: 05401 country: United States name: Kelly R Peck, Ph.D. role: CONTACT phone: 802-656-9610 email: Kelly.Peck@uvm.edu lat: 44.47588 lon: -73.21207 hasResults: False
<\|newrecord\|> nctId: NCT06288698 id: 53955721 briefTitle: Understanding Patient Engagement Trends in TBI Clinical Research overallStatus: NOT_YET_RECRUITING date: 2025-03 date: 2026-03 date: 2027-03 date: 2024-03-01 date: 2024-03-01 name: Power Life Sciences Inc. class: INDUSTRY briefSummary: Clinical trials, specifically focused on TBI, are crucial in assessing the safety and efficacy of new treatments. These trials serve as fundamental instruments in determining whether emerging medications outperform standard therapies, providing compelling evidence to support wider implementation.
The main goal is to thoroughly scrutinize trial completion rates and voluntary withdrawals among this particular group of patients. conditions: TBI studyType: OBSERVATIONAL observationalModel: CASE_CROSSOVER timePerspective: PROSPECTIVE count: 500 type: ESTIMATED measure: Number of TBI patients who decide to enroll in a clinical research measure: Rate of TBI patients who remain in clinical trial to trial completion sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Power Life Sciences city: San Francisco state: California zip: 94107 country: United States name: Michael B Gill role: CONTACT phone: 415-900-4227 email: https://www.withpower.com/contact-us@withpower.com lat: 37.77493 lon: -122.41942 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2024-02-23 uploadDate: 2024-02-23T11:01 filename: ICF_000.pdf size: 69900 hasResults: False
<\|newrecord\|> nctId: NCT06288685 id: 73/256 id: 73/256 type: OTHER domain: Police General Hospital briefTitle: Percutaneous Trigger Finger Release Concomitant Steroid Injection Versus Percutaneous Trigger Finger Release Alone overallStatus: COMPLETED date: 2023-10-11 date: 2024-01-23 date: 2024-01-30 date: 2024-03-01 date: 2024-03-12 name: Police General Hospital, Thailand class: OTHER briefSummary: Background:
Percutaneous A1 pulley release is a cost-effective and straightforward procedure with outcomes comparable to open A1 pulley release. Postoperative pain is a prevalent concern. Corticosteroid injection is a common nonoperative treatment for trigger finger, providing favorable outcomes but associated with a notable risk of recurrence. Numerous studies have explored the combined approach of percutaneous trigger finger release with corticosteroid injection. However, to date, there is no report on early postoperative results.
Objective:
To conduct a comparative analysis of early postoperative outcomes between percutaneous A1 pulley release with steroid injection and percutaneous A1 pulley release alone.
Study Design \& Methods:
This study constitutes a randomized controlled trial involving patients with trigger finger who underwent percutaneous release surgery from October 2023 to January 2024. A total of 38 patients were enrolled, with 18 assigned to the percutaneous A1 pulley release with steroid injection group and 20 to the percutaneous A1 pulley release alone group. Postoperative assessments included pain scores using the Visual Analog Scale (VAS), evaluation of quality of life through the QuickDASH score (qDASH), patient satisfaction, and complications. conditions: Trigger Finger conditions: Percutaneous A1 Pulley Release conditions: Steroid Injection conditions: Postoperative Pain studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Patients diagnosed with trigger finger, aged 18 years or older, and classified under Quinell's grade 2, 3, or 4, were included in the study \[ \]. Recruitment took place at the Outpatient Orthopedic Department of the Police General Hospital between October 2023 and January 2024. Exclusion criteria encompassed individuals with a history of prior hand surgery, Dupuytren's disease, type 1 diabetes, previous phalangeal fractures, recent steroid injection within the last month, and autoimmune diseases. primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Group allocation and Randomization:
Patients were enrolled and randomized into two groups, percutaneous A1 pulley release with steroid injection (Group A) and percutaneous A1 pulley release alone (Group B), by utilizing computer generate randomization and the results were put in opaque sealed envelopes. Informed consent was obtained from all participants, and surgeries were performed by the same surgeon (WJ). whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 38 type: ACTUAL name: percutaneous A1 pulley release name: Triamcinolone measure: postoperative pain score measure: hand function by quickDASH measure: patients satisfaction sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Police General Hospital city: Bangkok state: Pathumwan zip: 10330 country: Thailand lat: 13.75398 lon: 100.50144 hasResults: False
<\|newrecord\|> nctId: NCT06288672 id: 1002 briefTitle: IBS Skin Patch Test Food Allergy Study overallStatus: RECRUITING date: 2023-08-15 date: 2025-12 date: 2025-12 date: 2024-03-01 date: 2024-03-01 name: IBS-80, LLC class: INDUSTRY briefSummary: Participants with IBS are skin patch tested (no needles) to 80 different foods and food additives, compounded for patch testing, in search of food allergies. The testing requires 3 office visits within a 4 or 5 day period. The patches are taped to the back at Visit #. At Visit #2 48 hours later, the patches are removed from the skin and the outside border of each patch is marked with a felt tip marker. At Visit #3 (final visit) 1 or 2 days later, the patch test reading is performed by the doctor-investigator. An allergy is identified as a small red mark where the food was in contact with the skin for 48 hours. Those participants found to have food allergies are then placed on an avoidance diet (no calorie restriction) for 16 weeks where they either avoid eating the food(s) to which they are allergic (the \"true\" avoidance diet) or food(s) to which the testing did not show an allergy (this is called the \"sham\" avoidance diet). There is a 50/50 chance of going on either avoidance diet. The avoidance diet is assigned in such a way that neither the participant or the doctor-investigator knows which diet is being followed. After the 16 weeks, the participants answers a brief online questionnaire that asks about the IBS symptoms while following the avoidance diet. After the 16 week avoidance diet and final questionnaire are completed, those participants who were on the sham diet will be told of their true food allergies which they may try avoiding on their own. conditions: Irritable Bowel Syndrome studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants with IBS are patch tested to 80 type 4 food allergens. Those with questionable or positive patch test reactions are randomized to follow a patch test-directed avoidance diet or a sham diet (avoidance of foods to which the patch tests showed no reaction) for 16 weeks. Upon conclusion of the avoidance diet, participants complete a brief questionnaire to assess their response to the avoidance diet. primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: The true or sham avoidance diet for each participant is randomly assigned by the study administrator. Assignments will not be made available to participants until after their study completion or to investigators until all 250 participants have completed the study and the results have been analyzed. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 250 type: ESTIMATED name: True avoidance diet name: Sham avoidance diet measure: Post-Avoidance Diet Relative IBS Symptom Global Assessment sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Adult and Pediatric Dermatology status: RECRUITING city: Marlborough state: Massachusetts zip: 01752 country: United States name: Christy Williams, MD role: CONTACT phone: 508-460-9613 email: cwilliams@apderm.com name: Sally Iles, BSN, MBA role: CONTACT phone: 617-922-1130 email: SallyIles3@gmail.com name: Christy Williams, MD role: PRINCIPAL_INVESTIGATOR lat: 42.34593 lon: -71.55229 facility: Adult and Pediatric Dermatology status: RECRUITING city: Westford state: Massachusetts zip: 01886 country: United States name: Christy Williams, MD role: CONTACT phone: 508-460-9613 email: cwilliams@apderm.com name: Sally Iles, BSN, MBA role: CONTACT phone: 617-922-1130 email: SallyIles3@gmail.com name: Christy Williams, MD role: PRINCIPAL_INVESTIGATOR lat: 42.57926 lon: -71.43784 facility: Allergy & Asthma Care of New York status: NOT_YET_RECRUITING city: New York state: New York zip: 10016 country: United States name: Clifford Bassett, MD role: CONTACT phone: 212-260-6078 email: cliffbassett1@gmail.com name: Sally Iles, BSN, MBA role: CONTACT phone: 617-922-1130 email: SallyIles3@gmail.com name: Clifford Bassett, MD role: PRINCIPAL_INVESTIGATOR lat: 40.71427 lon: -74.00597 facility: Modern Dermatology NYC status: RECRUITING city: New York state: New York zip: 10016 country: United States name: Kathryn Frew, MD role: CONTACT phone: 929-533-1797 email: kathrynfrew37@gmail.com name: Sally Iles, BSN, MBA role: CONTACT phone: 617-922-1130 email: SallyIles3@gmail.com name: Kathryn Frew, MD role: PRINCIPAL_INVESTIGATOR lat: 40.71427 lon: -74.00597 facility: North Wales Dermatology, PLLC status: RECRUITING city: North Wales state: Pennsylvania zip: 19454 country: United States name: Michael B Stierstorfer, MD role: CONTACT phone: 215-699-1929 email: mbstierstorfer@gmail.com name: Sally Iles, BSN, MBA role: CONTACT phone: 617-922-1130 email: SallyIles3@gmail.com name: Michael B Stierstorfer, MD role: PRINCIPAL_INVESTIGATOR lat: 40.21094 lon: -75.27823 facility: Shepherd Allergy status: RECRUITING city: Barboursville state: West Virginia zip: 25504 country: United States name: Meagan Shepherd, MD role: CONTACT phone: 304-733-3333 email: allergy@shepherdallergy.com name: Sally Iles, BSN, MBA role: CONTACT phone: 617-922-1130 email: SallyIles3@gmail.com name: Meagan Shepherd, MD role: PRINCIPAL_INVESTIGATOR lat: 38.40953 lon: -82.29459 hasResults: False
<\|newrecord\|> nctId: NCT06288659 id: KY2024-050 briefTitle: aSAH Treatment Based on Intraventricular ICP Monitoring: A Prospective, Multicenter, Randomized and Controlled Trial acronym: ASTIM-MT overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-06-30 date: 2026-12-30 date: 2024-03-01 date: 2024-04-23 name: Huashan Hospital class: OTHER briefSummary: ASTIM is a multicenter, prospective, randomised, blinded end-point assessed trial, to investigate the efficacy and safety of treatment based on intracranial pressure monitoring in improving the prognosis of patients with aneurysmal subarachnoid hemorrhage. conditions: Aneurysmal Subarachnoid Hemorrhage conditions: Intracranial Pressure Increase studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 368 type: ESTIMATED name: Intraventricular intracranial pressure monitoring measure: The rate of good neurological functional prognosis measure: The rate of good neurological functional prognosis measure: The rate of good prognosis by Glasgow Outcome Scale-Extended (GOS-E) measure: Mortality measure: Incidence of VP shunt-related hydrocephalus measure: Incidence of Delayed Cerebral Ischemia measure: Incidence of epilepsy measure: Incidence of intracranial infection measure: Incidence of bleeding from puncture site measure: Incidence of poor healing in surgical incisions sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Neurosurgery, Huashan Hospital, Fudan University city: Shanghai state: Shanghai zip: 200000 country: China name: Xuehai Wu, Ph.D. role: CONTACT phone: +8613764880571 email: wuxuehai2013@163.com lat: 31.22222 lon: 121.45806 hasResults: False
<\|newrecord\|> nctId: NCT06288646 id: ROMEO 101712 briefTitle: Using Infrared Spectroscopy to Analyze Volatile Organic Compounds (VOCs) in the Breath of Patients With Lung Cancer overallStatus: RECRUITING date: 2023-04-24 date: 2024-04-24 date: 2024-12-15 date: 2024-03-01 date: 2024-03-01 name: Picomole Inc class: INDUSTRY name: Vitalite Health Network briefSummary: The goal of this clinical trial is to compare breath samples from patients with lung cancer, those with stable lung nodules, and individuals without lung cancer. The main questions it aims to answer are whether breath patterns are different in these groups and to see if breath patterns change after treatment in patients with lung cancer.
Participants will be asked to provide one breath sample, and two if they get treated. They will also be asked to fill out a questionnaire about their background and medical history. conditions: Lung Cancer conditions: Non Small Cell Lung Cancer studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 90 type: ESTIMATED measure: Differences in Breath Spectra of Lung Cancer, Stable Pulmonary Nodules, and Controls measure: Differences in breath spectra of patients with lung cancer before and after treatment sex: ALL minimumAge: 50 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Vitalite Health Network status: RECRUITING city: Moncton state: New Brunswick zip: E1C 8X3 country: Canada name: Nada Hammami role: CONTACT phone: 506-869-7391 email: Nada.Hammami@Vitalitenb.ca name: Marcel Mallet, MD role: PRINCIPAL_INVESTIGATOR lat: 46.09454 lon: -64.7965 hasResults: False
<\|newrecord\|> nctId: NCT06288633 id: FNWMRC briefTitle: Cardioneuroablation for Bradyarrhythmia acronym: CARDIOBOOST overallStatus: RECRUITING date: 2024-03-04 date: 2026-02-01 date: 2027-02-01 date: 2024-03-01 date: 2024-03-05 name: Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health class: OTHER name: Meshalkin National Medical Research Center, Ministry of Health of Russian Federation name: The Federal Centre of Cardiovascular Surgery, Russia name: Clinical City Hospital named after I.V. Davydovsky of Moscow Department of Healthcare name: City Clinical Hospital No.52 of Moscow Healthcare Department name: National Medical Research Center for Therapy and Preventive Medicine name: Medical Centre Hospital of the President's Affairs Administration, Republic of Kazakhstan name: Tomsk National Research Medical Center of the Russian Academy of Sciences name: Vishnevsky Center of Surgery name: National Medical Research Center for Cardiology, Ministry of Health of Russian Federation briefSummary: This is a multicenter prospective randomized blind controlled trial with a sham procedure group of the efficacy and safety of cardioneuroablation as a method of treating symptomatic bradycardia without a permanent pacemaker implantation conditions: Bradycardia conditions: Syncope conditions: Sick Sinus Syndrome studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 106 type: ESTIMATED name: Ganglionated plexi ablation name: Electrophysiological study measure: Implantation of a permanent cardiac pacemaker measure: Complications of cardioneuroablation measure: Presence of symptomatic or asymptomatic rhythm pauses >6 seconds measure: The presence of symptomatic or asymptomatic sinus bradycardia with an average heart rate <40 beats/min in the daytime measure: Transient or permanent atrioventricular block measure: Orthostatic hypotension and/or bradycardia during passive orthostasis test measure: Sinus tachycardia after cardioneuroablation measure: Implantation of a pacemaker by 24 months after randomization sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Almazov National Medical Research Centre status: RECRUITING city: Saint Petersburg country: Russian Federation name: Shlyakhto role: CONTACT phone: +78127023749 lat: 59.93863 lon: 30.31413 hasResults: False
<\|newrecord\|> nctId: NCT06288620 id: MA-EBC-II-024 briefTitle: Microwave Ablation in the Treatment of Early-stage Unifocal Invasive Breast Cancer overallStatus: RECRUITING date: 2024-02-25 date: 2025-05-10 date: 2025-05-30 date: 2024-03-01 date: 2024-03-01 name: The First Affiliated Hospital with Nanjing Medical University class: OTHER briefSummary: Microwave Ablative (MWA) therapy, as a minimally invasive thermal therapy, has been attempted to treat breast cancer of small lesions . However, the optimal indications for MWA in the treatment of breast cancer is unknown. This prospective, open-label, single-arm phase II clinical study was conducted to evaluate the efficacy and safety of MWA in the treatment of early-stage unifocal invasive breast cancer, and to explore the immune activating effect. conditions: Breast Cancer studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 77 type: ESTIMATED name: Microwave Ablation measure: Complete ablation rate measure: Safety of microwave ablation sex: FEMALE minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: the First Affiliated Hospital of Nanjing Medical University status: RECRUITING city: Nanjing state: Jiangsu country: China name: Wenbin Zhou, Professor role: CONTACT lat: 32.06167 lon: 118.77778 hasResults: False
<\|newrecord\|> nctId: NCT06288607 id: 2023-SR-708 briefTitle: Safety and Efficacy of High Intensity Focused Ultrasound in Solar Lentigo: A Self-controlled Study overallStatus: ACTIVE_NOT_RECRUITING date: 2023-11-16 date: 2024-04-18 date: 2024-04-18 date: 2024-03-01 date: 2024-03-06 name: The First Affiliated Hospital with Nanjing Medical University class: OTHER briefSummary: This trial is a single-center, prospective self-controlled study. The study proposes to recruit 30 patients with solar lentigo on both sides of the face. Patients are randomly assigned to be treated with high-intensity focused ultrasound (MFUS One, Hunan Peninsula Medical Technology Co., Ltd., China) on one side, and the other side is not treated. The Lab\* values of the lesion area and the area around the lesion are detected separately using 3nh HIGH-QUALITY COLORMETER colorimeter (Konica-Minolta Company, Japan), and skin lesion images are collected with dermatoscope and VISIA® (Canfield Company, USA). Measurements of Lab\* values and related images at the same location, along with adverse events, physician and subjective global aesthetic improvement scale scores are recorded before and at week2, week 4, week6. At the end of the follow-up on the treatment side, the same parameter treatment is provided for the untreated side, and the corresponding observation items are recorded for the patient before treatment, and at week2, week4, and week6 respectively. conditions: Solar Lentigo studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 30 type: ACTUAL name: High intensity focused ultrasound (MFUS One, Hunan Peninsula Medical Technology Co., Ltd., China) measure: Lab* values measure: Physician Global Aesthetic Improvement Scale measure: Subjective Global Aesthetic Improvement Scale sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Jiangsu Province Hospital, the First Affiliated Hospital of Nanjing Medical University city: Nanjing state: Jiangsu country: China lat: 32.06167 lon: 118.77778 hasResults: False
<\|newrecord\|> nctId: NCT06288594 id: DEU-PSI-HA-001 briefTitle: TraumaRelief App: A Pilot RCT Assessing Feasibility and Acceptability overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2024-09 date: 2024-12 date: 2024-03-01 date: 2024-03-06 name: Dokuz Eylul University class: OTHER briefSummary: The world experiences a high rate of traumatic events. Even if PTSD is not diagnosed, traumatic events can significantly affect people's lives. Traditional face-to-face therapies often face challenges, such as financial constraints, expensive therapy sessions, time restrictions, fear of stigma, and difficulties in accessing clinical psychologists. These challenges motivated us to develop new methods. Particularly in Turkey, there is neither sufficient infrastructure nor existing applications dedicated to addressing trauma-related complications. The development of the 'TraumaRelief' app is a pioneering initiative aimed at bridging this gap, targeting the resolution of these prevalent issues by introducing an accessible, innovative solution. The newly developed "TraumaRelief" app aims to provide solutions to these issues. This app contains eight modules: online video talks, psychoeducation, coping with symptoms, mindfulness-based relaxation exercises, imagery exposure, CBT (Cognitive Behavioral Therapy)-based daily exercises, therapist messaging, emergency contact access. The purpose of this study is to test the feasibility and acceptability of this newly developed application through a pilot randomized controlled trial. conditions: Post-Traumatic Stress Disorder (PTSD) studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is a three-arm, parallel randomized controlled trial. Upon enrollment, participants are randomly assigned to one of three groups. The first group will use the "TraumaRelief" application in addition to weekly video calls with a psychologist. The second group will use the "TraumaRelief" mobile application exclusively. The third group will serve as a control and receive no intervention. The primary outcomes will be measured at baseline, five weeks, one month, and three months post-intervention to assess the efficacy and acceptability of the mobile application and the added benefit of psychological support. primaryPurpose: TREATMENT masking: NONE maskingDescription: In this pilot randomized controlled trial, no masking is applied, as the nature of the interventions makes it impractical. Participants are informed of their group assignment since those in the second group are aware of their additional video call sessions with psychotherapists. The therapists conducting the sessions also need to be aware of the intervention they are delivering to properly adhere to the treatment protocol. This open-label approach is necessary to facilitate the intended psychotherapeutic interactions and to ensure that the intervention is delivered with fidelity, as per the study design. count: 105 type: ESTIMATED name: Application Plus Online Therapist Support Group name: Application Only Group measure: PTSD Symptom Severity measure: Depression Anxiety and Stress Symptom Severity measure: Quality of Life Improvement measure: Feasibility: Attrition Rate measure: Feasibility: Recruitment Rate measure: Feasibility: Retention Rate measure: Feasibility: Adherence Rate to the Mobile Application measure: Feasibility: Consent Rate measure: Feasibility: Fidelity of Intervention Delivery measure: Acceptability: System Usability Scale (SUS) Score for Acceptability measure: Acceptability: Preferred and Least Preferred Module Components measure: Acceptability: Application Utilization Frequency measure: Acceptability: Likelihood to Recommend the Application sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06288581 id: UDDS-Pedo-02-2024 briefTitle: U Shaped Toothbrush in Removing Plaque in Children overallStatus: RECRUITING date: 2024-02-01 date: 2024-05-01 date: 2024-08-01 date: 2024-03-01 date: 2024-03-01 name: Damascus University class: OTHER briefSummary: The aim of this study is to evaluate the effectiveness of a U-shaped toothbrush in removing plaque in preschool children which can be a simple, acceptable, and effective way to remove plaque in children in order to improve their oral health in the absence of parental supervision.
Children accepted in the study will be randomly divided into two groups:
The traditional toothbrush group and the U-shaped toothbrush group, All children aged four to five years will have their plaque assessed with the Turesky Modified Quigley Hein Index (TMQH) conditions: Dental Plaque studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: Traditional toothbrush group name: U shaped toothbrush group measure: Changing in plaque index sex: ALL minimumAge: 4 Years maximumAge: 5 Years stdAges: CHILD facility: Damascus University status: RECRUITING city: Damascus zip: 20872 country: Syrian Arab Republic name: Kamar Abdulrahman, MSc. student role: CONTACT phone: 00963957510093 email: kamarabdulrahman1@gmail.com lat: 33.5102 lon: 36.29128 hasResults: False
<\|newrecord\|> nctId: NCT06288568 id: Shift2Health briefTitle: Night Shift Work and Biomarkers of Obesity Risk in Hospital and Industry Workers acronym: Shift2Health overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-05-01 date: 2028-05-31 date: 2024-03-01 date: 2024-03-05 name: University of Vienna class: OTHER name: Medical University of Vienna name: FH Joanneum Gesellschaft mbH name: Wageningen University and Research name: Wageningen University name: University of Bremen name: Verein zur Förderung des Technologietransfers an der Hochschule Bremerhaven e.V. name: UNIVERSYTET MEDYCZNY W LODZI name: Københavns Universitet name: Charite University, Berlin, Germany name: Erasmus Medical Center briefSummary: Shift work is a well-known risk factor for the development of overweight and obesity, which may lead to downstream effects such as increased risk of cardiometabolic diseases and cancer. However, the biological and behavioral mechanisms underlying the obesogenicity of night shift work are not well understood. Population-based mechanistic studies in real life shift workers are needed to address how night shift work impacts metabolic health.
The investigators aim to characterize the behavioural, environmental, and biological mechanisms and pathways for the association of night shift work and obesity across Europe.
The investigators will conduct a cross sectional study in 5 European countries (Austria, Denmark, Germany, Netherlands and Poland) and recruit 1000 rotating night shift workers and day workers (200/country) from the health sector and different industries. Night and day workers will be age-frequency (3 age groups), gender and (where possible) working tasks matched. Participants will complete online questionnaires and report their diet habits in a mobile app. Body composition, dietary behavior and sensory preferences will be tested. Biologic specimens (blood, urine, saliva, hair and feces) will be collected at the workplace on a day where participants are working on a day shift (or a day off). In a subsample (Austria and Netherlands) shift workers will provide biological samples (spot blood, urine and saliva) both on a day shift and on a night shift. Biomarkers including hormones, cellular immunity and inflammation, parameters linked to gut health and metabolism of fat and sugar, appetite, oxidative stress, metabolomics and microbiota will be measured. The investigators hypothesize that compared to day workers, night shift workers will experience disrupted levels of pre-obesity markers. Higher circadian disruption, sleep disruption and mistimed eating patterns workers will be associated with more disrupted biomarker profiles. Among rotating shift workers, night shift will be associated with acute disrupted melatonin production, metabolomic profiles and composition of oral microbiota compared to a day shift. conditions: Obesity conditions: Shift-work Disorder conditions: Circadian Rhythm Disorders studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 1000 type: ESTIMATED name: No intervention measure: high-sensitive C-Reactive Protein (hs-CRP) measure: The investigators will consider levels of hormones in plasma measure: The investigators will consider levels of hormones in plasma measure: The investigators will consider levels of parameters linked to gut health in serum and in feces measure: The investigators will consider levels of parameters linked to gut health in serum and in feces measure: The investigators will consider levels of parameters linked to gut health in serum and in feces measure: The investigators will consider levels of parameters linked to gut health in serum and in feces measure: The investigators will consider parameters of cellular immunity and inflammation in plasma measure: The investigators will consider parameters of cellular immunity and inflammation in plasma measure: The investigators will consider parameters of cellular immunity and inflammation in plasma measure: The investigators will consider parameters of metabolism of fat and sugar in plasma measure: The investigators will consider parameters of metabolism of fat and sugar in plasma measure: The investigators will consider parameters of metabolism of fat and sugar in plasma measure: The investigators will consider parameters of metabolism of fat and sugar in plasma measure: The investigators will consider parameters of metabolism of fat and sugar in plasma measure: The investigators will consider levels of appetite markers in plasma measure: The investigators will consider levels of appetite markers in plasma measure: The investigators will consider levels of oxidative stress in whole blood, serum, plasma and urine measure: The investigators will consider levels of oxidative stress in whole blood, serum, plasma and urine measure: The investigators will consider levels of oxidative stress in whole blood, serum, plasma and urine measure: The investigators will consider levels of oxidative stress in whole blood, serum, plasma and urine measure: The investigators will consider levels of oxidative stress in whole blood, serum, plasma and urine measure: The investigators will consider metabolomics analysis of plasma samples and dry blood spots (DBS) measure: The investigators will consider microbiome analysis of feces samples and tongue swabs sex: ALL minimumAge: 21 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06288555 id: 020/2566 briefTitle: Validation of Ipswich Touch Test for Diabetic Peripheral Neuropathy Screening in Primary Care overallStatus: COMPLETED date: 2023-12-21 date: 2024-01-23 date: 2024-01-23 date: 2024-03-01 date: 2024-03-05 name: Ponlawat Hanchana, MD class: OTHER_GOV briefSummary: The goal of this observational study is to assess the accuracy of screening for diabetic peripheral neuropathy by comparing the Ipswich touch test with the 10-g monofilament test in patients diagnosed with type 2 diabetes.
The main question it aims to answer is:
How does the accuracy of the Ipswich Touch Test for identifying peripheral neuropathy compare to the traditional 10-g monofilament test?
Participants underwent both the Ipswich touch test and the 10-g monofilament test. conditions: Diabetic Foot studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 274 type: ACTUAL name: Ipswich touch test measure: The accuracy of the Ipswich touch test sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ponlawat Hanchana, MD city: Saraburi zip: 18120 country: Thailand lat: 14.53333 lon: 100.91667 hasResults: False
<\|newrecord\|> nctId: NCT06288542 id: MD-250-2022 briefTitle: Preoperative Dextrose Infusion and Postoperative Nausea and Vomiting overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-05-01 date: 2024-05-01 date: 2024-03-01 date: 2024-03-01 name: Cairo University class: OTHER briefSummary: This research aims to investigate the efficacy of preoperative intravenous infusion of dextrose 5% during fasting in lowering the incidence and severity of post-operative nausea and vomiting related to laparoscopic gynaecologic procedures conditions: Effect of Dextrose on Postoperative Nausea and Vomiting studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 111 type: ESTIMATED name: group d name: group R measure: frequency of post-opertive nausea and vomiting in 24 hour measure: TOTAL AMOUNT OF ANTIEMETIC REQUIRED sex: FEMALE minimumAge: 20 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06288529 id: 1 briefTitle: EFFECT SGLT2 INHIBITORS ON CONTRAST MEDIUM INDUCED ACUTE KIDNEY INJURY overallStatus: COMPLETED date: 2023-07-15 date: 2023-12-31 date: 2024-01-31 date: 2024-03-01 date: 2024-03-01 name: University of Health Sciences Balikesir Hospital Eduation and Research class: OTHER_GOV briefSummary: Chronic kidney disease and type 2 diabetes mellitus patients are with in high-risk patients in coronary arterial diseases and increasing number of coronary angiography and coronary interventional procedures have been performed in these population. As well as the risk factors have been identified by many studies preventive measures are lacking.
In our study we found that SGLT2 inhibitors are beneficial in terms of reducing contrast media induced acute kidney injury in both diabetic and CKD patients.This is one of the leading studies in the literature pointing that SGLT2 inhibitors may have a potentially beneficial role in reducing or preventing the development of PC-AKI. conditions: Chronic Kidney Diseases conditions: Type2diabetes studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 975 type: ACTUAL measure: Development of post-contrast acute kidney injury sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Health Sciences Balikesir Education and Research Hospital city: Balıkesir zip: 10100 country: Turkey lat: 39.64917 lon: 27.88611 hasResults: False
<\|newrecord\|> nctId: NCT06288516 id: 7484 briefTitle: BenRalizumab Effect on Airway Remodeling in Severe asTHma acronym: BREATH overallStatus: RECRUITING date: 2024-03-01 date: 2025-12-31 date: 2026-06-01 date: 2024-03-01 date: 2024-03-04 name: Aristotle University Of Thessaloniki class: OTHER name: Pulmonary Clinic, Aristotle University of Thessaloniki, Greece name: Pulmonary Clinic, University of Ioannina name: Pulmonary Clinic, Democritus University of Thrace name: 2nd Pulmonary Clinic, Kapodistrian University of Athens name: University Hospital of Crete name: Pulmonary and Respiratory Failure Department, National and Kapodistrian University of Athens name: University Hospital of Patras briefSummary: Response to biologic therapies in severe asthma is variable, with patients being either non-responders, responders or super-responders. There is currently no explanation for this broad variation in response. It is important to examine whether these patients have distinct characteristics that could help the treating physician in making the correct diagnosis in clinical practice.
Aim of this clinical study is to evaluate the efficacy of benralizumab, a humanized an anti-interleukin 5 receptor α monoclonal antibody in patients with severe eosinophilic asthma and to evaluate airway remodeling before and after benralizumab treatment.
Hypothesis Identification of pathological and clinical characteristics in patients with severe eosinophilic asthma after benralizumab treatment regarding the airway remodeling, inflammatory cells, and other biomarkers on a long-term basis.
Research questions Is there any improvement in airway remodeling? Are there any biomarkers to predict response to benralizumab treatment in severe eosinophilic asthmatic patients? conditions: Asthma; Eosinophilic conditions: Airway Remodeling studyType: INTERVENTIONAL phases: PHASE4 allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Benralizumab (30mg) administered subcutaneously every 4 weeks for the first 3 dose and then every 8 weeks primaryPurpose: TREATMENT masking: NONE count: 45 type: ESTIMATED name: Benralizumab 30 mg/ml measure: Change in sub-basement membrane thickness measure: Change in airway smooth muscle area measure: Change in airway smooth muscle layer thickness measure: Change in submucosal eosinophil number measure: Change in epithelial integrity measure: Change in collagen thickness measure: Change of cytokine and protein levels measure: Change in exacerbation rate measure: Change in blood eosinophil levels measure: dentification of clinical characteristics of response, change in Forced Expiratory Volume (FEV1) sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Pulmonary Clinic, Aristotle University of Thessaloniki, George Papanikolaou Hospital status: RECRUITING city: Thessaloniki zip: 57010 country: Greece name: Kalliopi Domvri, Dr role: CONTACT phone: 00302313307258 email: kdomvrid@auth.gr name: Konstantinos Porpodis, Prof role: CONTACT phone: 00302313307179 email: kporpodis@yahoo.gr lat: 40.64361 lon: 22.93086 hasResults: False
<\|newrecord\|> nctId: NCT06288503 id: HRF2023 briefTitle: Hydrolysed Rice Formula Study overallStatus: RECRUITING date: 2024-02-01 date: 2027-07 date: 2027-07 date: 2024-03-01 date: 2024-03-01 name: Nutricia UK Ltd class: INDUSTRY briefSummary: This non-inferiority study aims to determine whether a hydrolysed rice protein formula is as effective as a cow's milk protein based extensively hydrolysed formula using a double-blind, randomised-controlled design over a 28-day intervention period followed by a 2-month follow-up period in infants 0-13 months of age presenting with symptoms/clinical history suggestive of cow's milk allergy. The primary outcome is growth, and secondary outcomes are gastrointestinal tolerance, and differences in intake, allergic symptoms, parental QOL, acceptability, dietary intake, and safety. conditions: Cow's Milk Protein Allergy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 86 type: ESTIMATED name: Hydrolysed Rice Protein Formula name: Cow's Milk Based Extensively Hydrolysed Formula measure: Growth measure: Gastrointestinal Tolerance measure: Stool frequency and consistency measure: Study Product Intake measure: Patient Orientated Scoring Atopic Dermatitis Symptoms (PO-SCORAD) measure: Patient Reported Atopic Symptoms measure: Cow's Milk Related Symptom Score measure: Food Allergy Quality of Life-Parental Burden (FAQL-PB) measure: Acceptability of the Study Formula measure: Nutrient Intake (Energy, Protein, Micronutrients) measure: Dietetic Goal measure: Overall Safety sex: ALL minimumAge: 0 Months maximumAge: 13 Months stdAges: CHILD facility: Gloucestershire Royal NHS Trust status: RECRUITING city: Gloucester state: Gloucestershire zip: GL1 3NN country: United Kingdom name: Victoria Bittle role: CONTACT phone: 0300 422 5506 email: v.bittle@nhs.net lat: 51.86568 lon: -2.2431 facility: Bristol Royal Hospital for Children status: RECRUITING city: Bristol state: Somerset zip: BS16 1TA country: United Kingdom name: Sarah Trace role: CONTACT phone: 0117 3428802 email: sarah.trace@uhbw.nhs.uk lat: 51.45523 lon: -2.59665 hasResults: False
<\|newrecord\|> nctId: NCT06288490 id: AMCS-009 briefTitle: A Single Arm Study Comparing ACC Supplement to CCS in Management of Hypoparathyroidism acronym: AMCS009 overallStatus: TERMINATED date: 2013-04 date: 2014-06 date: 2014-06-25 date: 2024-03-01 date: 2024-03-01 name: Amorphical Ltd. class: INDUSTRY briefSummary: Primary objective:
Phase I Proof of concept: treatment with smaller doses of elemental calcium from ACC compared to CCS can maintain target serum calcium (corrected for albumin) values (7.0-10.0 mg/dL).
Phase II To test the hypothesis that treatment with smaller doses of elemental calcium from ACC compared to CCS can maintain target serum calcium (corrected for albumin) values (7.0-10.0 mg/dL).
Secondary objectives:
Phase I
* ACC dose selection - to confirm the conversion factor of ACC from CCS
* To determine the effect of food on ACC absorption
Phase II
* To test the hypothesis that treatment with smaller doses of elemental calcium from ACC compared to CCS will not cause an increase in hypercalciuria in patients with hypoparathyroidism
* To test the hypothesis that smaller doses of elemental calcium from ACC can reduce the side effects related with high calcium consumption.
Amorphical has a strong basis to believe that the ACC product is better absorbed compared to the commercially available CCS products and therefore, can maintain desirable target albumin corrected calcium values in serum (CA) with smaller doses of elemental calcium from ACC. As results, the burden of taking high doses of calcium supplementation along with the side effects of the standard therapy (gastrointestinal discomfort and hypercalciuria) will be reduced.
Testing serum CA and urine calcium values in subjects with hypoparathyroidism may provide a straightforward method to test this hypothesis.
The study is designed to be conducted with extra precaution in order to avoid disturbing the fragile balance between CA levels in serum and calcium levels urine. The crossover design of phase II of the study allows a more accurate and reliable comparison of results attributable to the specific treatment within the same individual. In addition, the subjects will continue consuming all their routine medication throughout the trial. The subjects in the control arm will consume their routine calcium supplement doses thus, will be treated with a standard of care. conditions: Hypoparathyroidism studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Proof of concept: treatment with smaller doses of elemental calcium from ACC compared to CCS can maintain target serum calcium (corrected for albumin) values (7.0-10.0 mg/dL) primaryPurpose: TREATMENT masking: NONE count: 10 type: ACTUAL name: amorphous calcium carbonate measure: Calcium (albumin-corrected) serum level - composite value based on multiple measurements measure: Urine calcium level - 24h urine collection measure: Phosphorous serum level - composite value based on multiple measurements measure: Urine calcium level - 24h urine collection measure: Urine calcium level - 24h urine collection measure: Assessment of symptoms and signs related with hypocalcemia - composite value based on multiple measurements measure: Urine creatinine level - 24h urine collection measure: Urine creatinine level - 24h urine collection measure: Urine creatinine level - 24h urine collection measure: Urine phosphorus level - 24h urine collection measure: Urine phosphorus level - 24h urine collection measure: Urine phosphorus level - 24h urine collection sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Rambam Health Care Campus city: Haifa zip: 31096 country: Israel lat: 32.81841 lon: 34.9885 hasResults: False

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