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Secondary outcomes: (1) Postoperative early pain (Visual Analog Score (VAS) at 6th and 24th hours of the surgery) (2) intraoperative complications, (3) postoperative complications conditions: Gynecologic Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: SINGLE whoMasked: PARTICIPANT count: 140 type: ESTIMATED name: Manipulator-assisted Abdominal Hysterectomy measure: Duration of the surgical procedure measure: Postoperative pain at 6th hours measure: Postoperative pain at 24th hours measure: intraoperative complications measure: Postoperative complications sex: FEMALE minimumAge: 40 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Dr.Lütfi Kırdar City Hospital city: Istanbul zip: 34000 country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False |
<|newrecord|> nctId: NCT06374927 id: PHRASE-2023 briefTitle: Personalised Health Cognitive Assistance for RehAbilitation SystEm (PHRASE): A Feasibility Study acronym: PHRASE-2023 overallStatus: RECRUITING date: 2024-04-25 date: 2024-10-01 date: 2024-10-30 date: 2024-04-19 date: 2024-04-23 name: Donders Centre for Neuroscience class: OTHER briefSummary: The incidence of cognitive and neuromotor impairment caused by strokes has become a growing challenge. |
The patient's journey to recovery in the healthcare system involves multiple phases, spanning from initial hospitalization to in-patient and out-patient rehabilitation, finally leading to the patient's return to home. The access to stroke units and rehabilitation varies within Europe. Unfortunately, not everyone has access to rehabilitation programs, and the benefits derived from these programs often decline after hospital discharge. |
Currently, the support of the patient is organized in a rather fragmented way, and informal care sometimes places a severe burden requiring dedicated support in the patient's social environment. The PHRASE project proposes to deploy rehabilitation technology such as the Rehabilitation Gaming System (RGS) to instil and support a virtuous cycle of stroke patients' recovery in the at-home setting. RGS is an effective advanced digital tool for rehabilitation programs that uses Augmented Reality (AR)- and Virtual Reality (VR)-based gamified training grounded on neuroscientific principles, that has been shown to promote cognitive and motor recovery after a stroke at the clinic and home. |
There are many dedicated cognitive therapies, but most rehabilitation outcomes are mostly limited to the task trained and do not extend to day-to-day function or remain unconvincing. Based on recent literature, the PHRASE RGS-based system can provide an effective tool to address cognitive impairment using VR-based interventions. In a previous study, the neuropsychological test battery was compiled by the neuropsychologist and covered four cognitive domains: 1. basic attention, 2. memory (short-term memory), 3. visuospatial memory, and 4. executive function. All these functions were tested using VR-based tasks. The conclusion of this study confirms the possibility of addressing cognitive impairment effectively using VR-based interventions when properly mapped with clinical scales. |
The validation of the PHRASE system with post-stroke patients is needed to strengthen its usefulness and effectiveness for cognitive rehabilitation at home. For this, a feasibility study will be conducted to measure its usability, adherence, acceptance, and the user's experience. |
The investigators will also explore the effectiveness of the PHRASE system in improving cognitive function (attention, memory, executive function) after stroke. |
Participants: stroke patients at different time points after stroke (acute, subacute, and chronic), aged over 18 years. The participants will integrate the PHRASE technology into their daily routines in parallel to their regular neurorehabilitation treatment for 6 weeks. conditions: Stroke studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 150 type: ESTIMATED name: Rehabilitation Gaming System (VR-based mobile application) measure: Usability measure: User experience measure: Adherence measure: Acceptance measure: The Montreal Cognitive Assessment (MoCA) measure: Fugl-Meyer Assessment of the sensorimotor function of the upper limb (FMA-UE) measure: Hamilton Depression Rating Scale (HDRS) measure: Fatigue Severity Scale (FSS) measure: Pain Visual Analogue Scale (VAS) measure: Barthel Index (BI) measure: EuroQol - 5 Dimension - 5 Level (EQ-5D-5L) measure: Modified Ashworth scale (MAS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Centre hospitalier universitaire de Limoges status: NOT_YET_RECRUITING city: Limoges zip: 87000 country: France name: Stephane Mandigout, Dr. role: CONTACT email: [email protected] lat: 45.83153 lon: 1.25781 facility: Cluj Rehabilitation Hospital status: NOT_YET_RECRUITING city: Cluj-Napoca state: Cluj zip: 400066 country: Romania name: Stefan Strilciuc, PhD. role: CONTACT email: [email protected] lat: 46.76667 lon: 23.6 facility: Parc Sanitari Sant Joan de Déu status: RECRUITING city: Barcelona country: Spain name: Raffaele Fiorillo, Dr. role: CONTACT email: [email protected] name: Raffaele Fiorillo role: PRINCIPAL_INVESTIGATOR lat: 41.38879 lon: 2.15899 facility: IRF La Salle status: NOT_YET_RECRUITING city: Madrid country: Spain name: Miguel Gómez Martínez, Dr. role: CONTACT email: [email protected] name: Miguel Gómez Martínez, Dr. role: PRINCIPAL_INVESTIGATOR lat: 40.4165 lon: -3.70256 hasResults: False |
<|newrecord|> nctId: NCT06374914 id: TUO-UR-23-05 briefTitle: Sequential Intravesical Gemcitabine and Docetaxel for Rescue Therapy in BCG Unresponsive Non-muscle Invasive Bladder Cancer Patients overallStatus: NOT_YET_RECRUITING date: 2024-04-09 date: 2026-04-09 date: 2026-04-09 date: 2024-04-19 date: 2024-04-19 name: Dokuz Eylul University class: OTHER briefSummary: Studies in the literature are limited both throughout Turkey and in general. For this reason, as a result of the study that we will create, it will provide us with information for bladder protective treatments in patients who do not respond to BCG therapy in bladder cancer patients. conditions: Bladder Cancer conditions: BCG conditions: Gemcitabine conditions: Docetaxel conditions: Intravesical Instillation studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 120 type: ESTIMATED name: Intravesical Solution measure: Recurrence rate measure: Progression rate measure: Adverse effects of intravesical chemotherapy measure: Intravesical chemotherapy versus radical cystectomy measure: treatment change sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Dokuz Eylul University Faculty of Medicine Department of Urology city: Izmir state: Other (Non U.s.) zip: 35330 country: Turkey name: Muhammed Selcuk Ozer, Medical Doctor role: CONTACT phone: +905543078941 email: [email protected] name: Ozan Bozkurt, Professor role: CONTACT email: [email protected] name: Ozan Bozkurt, Professor role: PRINCIPAL_INVESTIGATOR lat: 38.41273 lon: 27.13838 hasResults: False |
<|newrecord|> nctId: NCT06374901 id: IRB-2024-311 briefTitle: Tislelizumab Combined With Neoadjuvant Chemotherapy Used in the Perioperative Treatment. overallStatus: NOT_YET_RECRUITING date: 2024-04-25 date: 2026-03-31 date: 2028-03-31 date: 2024-04-19 date: 2024-04-19 name: Xiangdong Cheng class: OTHER name: Liaoning Tumor Hospital & Institute name: Shanxi Province Cancer Hospital name: Sichuan Cancer Hospital and Research Institute name: The Second Affiliated Hospital of Harbin Medical University briefSummary: To evaluate the efficacy of Tislelizumab in combination with chemotherapy versus chemotherapy in neoadjuvant treatment of patients with MHC-II positive (IHC≥2+) and locally advanced gastric/gastroesophageal junction adenocarcinoma by evaluating the main pathologic response rate (MPR). conditions: Gastric Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 134 type: ESTIMATED name: Tislelizumab name: SOX/XELOX measure: MRP (Main pathological response) measure: pCR (pathologic complete response) measure: DFS (Disease free survival) measure: OS (Overall survival) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital) city: Hangzhou state: Zhejiang country: China lat: 30.29365 lon: 120.16142 hasResults: False |
<|newrecord|> nctId: NCT06374888 id: CVL009-2002 briefTitle: Nilatinib Maleate Tablets Combined With Capecitabine in the Treatment of HER2-positive Advanced Esophageal/Esophagogastric Junction/Gastric Adenocarcinoma With Brain Metastases overallStatus: NOT_YET_RECRUITING date: 2024-04-30 date: 2026-09-30 date: 2027-07-30 date: 2024-04-19 date: 2024-04-19 name: Convalife (Shanghai) Co., Ltd. class: INDUSTRY briefSummary: To evaluate the efficacy of nilatinib maleate tablets combined with capecitabine in the treatment of HER2-positive advanced esophageal/esophagogastric junction/gastric adenocarcinoma with brain metastasis. conditions: Her2-positive Advanced Esophageal/Esophagogastric Junction/Gastric Adenocarcinoma With Brain Metastasis studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Her2-positive advanced esophageal/esophagogastric junction/gastric adenocarcinoma with brain metastases primaryPurpose: TREATMENT masking: NONE count: 28 type: ESTIMATED name: Neratinib maleate in combination with capecitabine measure: Objective response rates of the central nervous system as assessed by the Independent Imaging Evaluation Committee based on RECIST1.1 measure: Central nervous response rate measure: Objective response rates outside the central nervous system measure: Disease control rate measure: Duration of reaction measure: Clinical benefit rate measure: overall survival sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06374875 id: 24-213 briefTitle: Fibrosis Lessens After Metabolic Surgery acronym: FLAMES overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2029-05-31 date: 2029-12-31 date: 2024-04-19 date: 2024-04-19 name: Ali Aminian class: OTHER briefSummary: Metabolic dysfunction-associated steatotic liver disease (MASLD), formerly known as non-alcoholic fatty liver disease (NAFLD), a major global public health concern, is commonly associated with obesity, diabetes, and dyslipidemia. MASLD is currently the most common cause of chronic liver disease affecting about 80% of people with obesity, ranging from simple fat deposits in the liver to Metabolic Dysfunction-Associated Steatohepatitis (MASH), cellular injury, advanced fibrosis, cirrhosis, or hepatocellular carcinoma. Patients with MASH are also at risk for cardiovascular disease and mortality. There is no universally approved medication for MASH. Weight loss remains the cornerstone of MASH treatment. |
Patients meeting the inclusion and exclusion criteria and who give informed consent will be enrolled in the trial and undergo the baseline liver biopsy (if none available). Approximately 120 patients with MASH and liver fibrosis (F1-F4 in baseline liver biopsy) will be randomized in a 1:1 ratio to metabolic surgery or medical treatment (incretin-based therapies ± other medical therapies for MASH) and followed for 2 years at which time a repeat liver biopsy will be performed for the assessment of the primary end point. conditions: Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD) conditions: Non-Alcoholic Fatty Liver Disease conditions: Metabolic Dysfunction-Associated Steatohepatitis (MASH) conditions: Liver Fibrosis conditions: Obesity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Patients will be randomized in a 1:1 ratio into 1 of the 2 arms using a computer-generated randomization plan, stratified to ensure that there are equal number of patients with/without T2DM and with/without F4 (cirrhosis) according to the baseline liver biopsy in each treatment group (surgical group vs non-surgical group). The participant sites are regrouped into three geographic regions. All patients in each region will be randomized separately to have equal number of patients with/without T2DM and with/without F4 in each treatment group in each region. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Patients and investigators will not be blinded to treatment assignment. The treatment assignment will remain unknown until the patient is randomized after meeting all eligibility requirements. |
Pathologists who report the liver biopsies (to assess the primary end point of study) are blinded to treatment assignment whoMasked: OUTCOMES_ASSESSOR count: 120 type: ESTIMATED name: Metabolic surgery name: Incretin-Based Therapy measure: Improvement of at least 1 fibrosis stage of the Kleiner fibrosis classification and no worsening of MASH in the repeat liver biopsy. measure: MASH resolution in the repeat liver biopsy measure: MASH resolution and fibrosis improvement in the repeat liver biopsy measure: Fibrosis progression in the repeat liver biopsy measure: Average Weight loss percentage measure: Disease-specific Quality of Life (QoL) measure: MASLD-related histopathologic end points measure: MASLD-related laboratory end points measure: MASLD-related liver scan end points measure: MASLD-related clinical end points measure: Achieved Weight-loss proportions measure: Weight change (kg) measure: BMI change (kg/m^2) measure: Excess weight loss, % measure: Change in waist circumference, cm measure: Systolic blood pressure trends, mmHg measure: Mean and change from baseline in lipid panel, mg/dl measure: Changes in glucose hemostasis markers measure: Percentage of patients with T2DM meeting predefined HbA1c targets measure: Changes in inflammatory markers, CRP mg/L measure: Change in cardiovascular and diabetes medications measure: SF-Bari Score measure: Quality of life end points measure: Safety end points sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Banner Health Center city: Phoenix state: Arizona zip: 85006 country: United States name: Farah Husain, MD role: CONTACT email: [email protected] lat: 33.44838 lon: -112.07404 facility: Indiana University city: Indianapolis state: Indiana zip: 46202 country: United States name: Dimitrios Stefanidis, MD, PhD role: CONTACT email: [email protected] lat: 39.76838 lon: -86.15804 facility: Mayo Clinic city: Rochester state: Minnesota zip: 55905 country: United States name: Omar Ghanem, MD role: CONTACT email: [email protected] lat: 44.02163 lon: -92.4699 facility: Cleveland Clinic city: Cleveland state: Ohio zip: 44195 country: United States name: Ali Aminian, MD role: CONTACT email: [email protected] lat: 41.4995 lon: -81.69541 facility: Hospital Alemão Oswaldo Cruz city: São Paulo country: Brazil name: Ricardo Cohen, MD role: CONTACT email: [email protected] lat: -23.5475 lon: -46.63611 facility: McGill University city: Montréal country: Canada name: Amin Andalib, MDCM, MSc role: CONTACT email: [email protected] lat: 45.50884 lon: -73.58781 facility: Turku University Hospital city: Turku country: Finland name: Paulina Salminen, MD, PhD role: CONTACT email: [email protected] lat: 60.45148 lon: 22.26869 facility: Sri Aurobindo Institute of Medical Sciences city: Indore country: India lat: 22.71792 lon: 75.8333 facility: The Digestive Health Institute city: Mumbai country: India lat: 19.07283 lon: 72.88261 facility: University College Dublin city: Dublin country: Ireland name: Helen Heneghan, MB BCh BAO, PhD role: CONTACT email: [email protected] lat: 53.33306 lon: -6.24889 facility: Università Cattolica del Sacro Cuore city: Milan country: Italy name: Geltrude Mingrone, M.D. PhD role: CONTACT email: [email protected] lat: 45.46427 lon: 9.18951 facility: Sapienza Università di Roma city: Roma country: Italy name: Giovanni Casella, MD role: CONTACT email: [email protected] lat: 41.89193 lon: 12.51133 facility: Kuwait University city: Kuwait country: Kuwait lat: 29.36972 lon: 47.97833 facility: Instituto Nacional de Ciencias Médicas y Nutrición Salvador city: Mexico City country: Mexico name: Mauricio Sierra, MD role: CONTACT lat: 19.42847 lon: -99.12766 facility: Hospital Clínic Barcelona city: Barcelona country: Spain lat: 41.38879 lon: 2.15899 facility: Linköping University city: Linköping country: Sweden lat: 58.41086 lon: 15.62157 facility: Örebro University city: Örebro country: Sweden name: Erik Stenberg, MD, PhD role: CONTACT email: [email protected] lat: 59.27412 lon: 15.2066 facility: Clarunis Universitäres city: Basel country: Switzerland name: Ralph Peterli, Dr. med role: CONTACT email: [email protected] lat: 47.55839 lon: 7.57327 facility: Hôpitaux universitaires de Genève city: Geneva country: Switzerland name: Minoa Jung, PD Dr. med. role: CONTACT email: [email protected] lat: 46.20222 lon: 6.14569 facility: Nuffield Health Bristol Hospital city: Bristol country: United Kingdom name: Dimitri Pournaras, PhD role: CONTACT email: [email protected] lat: 51.45523 lon: -2.59665 facility: King's College Hospital city: London country: United Kingdom name: Francesco Rubino, MD role: CONTACT email: [email protected] lat: 51.50853 lon: -0.12574 facility: Queen Mary University city: London country: United Kingdom name: William Alazawi, MB BChir PhD role: CONTACT email: [email protected] lat: 51.50853 lon: -0.12574 hasResults: False |
<|newrecord|> nctId: NCT06374862 id: PI2024_843_0008 briefTitle: Effects of Specific Thoracic Spine Mobilizations on Muscle Activity in a Healthy Volunteer Population acronym: RACHI-MOB overallStatus: RECRUITING date: 2024-03-28 date: 2025-10 date: 2025-10 date: 2024-04-19 date: 2024-04-19 name: Centre Hospitalier Universitaire, Amiens class: OTHER briefSummary: In this study, the investigators will examine the effect of manual therapy on the thoracic spine and its impact on the muscular strength gain of the thoracic extensors. Treatment with manual therapy, as described by Maitland, consists of a specific mobilization of the thoracic spine in the postero-anterior direction on the transverse and spiny processes of the thoracic vertebrae. To ensure the relevance of the measures, and to better control the occurrence of biases inherent to the practice of manual therapy, the investigators constituted three distinct groups: an intervention group, a control group and a group without intervention. In short, this methodology will allow us to explore in detail the effects of specific spinal mobilization on motor control, while taking into account placebo response elements and natural variations in the results conditions: Musculoskeletal Manipulations conditions: Range of Motion conditions: Muscle Strength conditions: Peripheral Joints in Upper Quarters studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 156 type: ESTIMATED name: mobilization name: no effect measure: electrical activity assessment of the spine extensor muscles using EMG sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHU Amiens Picardie status: RECRUITING city: Amiens state: Picardie zip: 80054 country: France name: Vicente BELTRAN AIBAR role: CONTACT phone: 03.22.45.59.92 email: [email protected] name: François-Régis Sarhan role: SUB_INVESTIGATOR lat: 49.9 lon: 2.3 hasResults: False |
<|newrecord|> nctId: NCT06374849 id: PI2023_843_0173 briefTitle: Intraoperative Sufentanil and Chronic Postsurgical Pain in Non-major Scheduled Abdominal Surgery acronym: ISPAIN overallStatus: RECRUITING date: 2024-03-17 date: 2026-04 date: 2026-07 date: 2024-04-19 date: 2024-04-19 name: Centre Hospitalier Universitaire, Amiens class: OTHER briefSummary: Several risk factors for chronic postoperative pain have been identified. A series of studies have shown that administrating intraoperatively a high dose of Remifentanil is associated with an increased incidence of CPSP. These findings highlight a risk factor for CPSP that the anaesthetist can influence on, but they however remain limited to remifentanil. To this day, no study have attempted to evaluate the existence of such an association between the incidence of CPSP and the intraoperative administration of sufentanil doses. Improved knowledge of the long-term nociceptive impact of intraoperative sufentanil administration would enable better therapeutic adaptation according to each patient's risk. |
In the field of CPSP, non-major abdominal surgeries remain poorly studied. This is due to their lower risk of CPSP than other surgeries such as orthopaedic, mammary or thoracic surgery. Nevertheless, they constitute a large number of daily surgical procedures. The estimated incidence of CPSP in non-major abdominal surgery appears in several studies to be between 15 and 20% The aim of this study is to evaluate the correlation between the intraoperative administration of sufentanil doses and the incidence of CPSP at 3 months in patients undergoing non-major scheduled abdominal surgery. conditions: Chronic Postsurgical Pain conditions: Chronic Pain conditions: Abdominal Surgery conditions: Sufentanil conditions: Risk Factors studyType: INTERVENTIONAL phases: PHASE4 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 855 type: ESTIMATED name: phone interview measure: Incidence of CPSP measure: Post-operative pain intensity measure: Post-operative pain intensity sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHU Amiens-Picardie status: RECRUITING city: Amiens zip: 80054 country: France name: Paul TARPIN, MD role: CONTACT phone: 0322087980 email: [email protected] name: Ottilie Fumery, MD role: SUB_INVESTIGATOR name: Stephane BAR, Pr role: SUB_INVESTIGATOR name: Benjamin Mestan, MD role: SUB_INVESTIGATOR lat: 49.9 lon: 2.3 hasResults: False |
<|newrecord|> nctId: NCT06374836 id: nWMO 2024.040 briefTitle: The Contractile Response of the Thoracic Aorta to Vasoactive Substances acronym: AorticContract overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2024-08 date: 2024-12 date: 2024-04-19 date: 2024-04-24 name: Catharina Ziekenhuis Eindhoven class: OTHER name: Maastricht University briefSummary: Hypertension affects 32-35% of the global adult population. Despite many drugs being available hypertension is not controlled in 50% of the over 500 million treated people leaving patients with an elevated blood pressure for life. |
In the development of isolated systolic hypertension, the aorta plays a pivotal role. With each heartbeat, the heart empties its stroke volume into the large arteries. These arteries, particularly the thoracic part of the aorta, temporarily distend to buffer the stroke volume and thereby dampen the pressure fluctuation: they have a Windkessel function. When this function is reduced (and arterial stiffness is increased), the heart needs to contract more forcefully during ejection, leading to isolated systolic hypertension. |
Likely, the aorta is not just a passive structure (the aorta as an elastic 'bicycle tube'). Rather, the smooth muscle cells in the aorta wall can presumably actively change the aorta's dimension through vasoconstriction/-dilation. If this is the case, such vasoconstriction/-dilation will have direct consequences for the aorta's Windkessel function and, since this Windkessel function directly influences the blood pressure flucturation, also for hypertension and its progression. Therefore, the aim of this study is to quantify the thoracic aorta's ability to vasoconstrict, and to assess whether this contractility is related to specific predictors. |
During the study we will measure in the operating room the thoracic descending and ascending aortic diameter with transoesopahgeal echocardiography (part of standard clinical care), before and after administration of vasoactive drugs (phenylephrine and norepinephrine; also part of standard clinical care). During these measurements we will simultanesouly measure peripheral arterial blood pressure and an electrocardiogram (ECG, to monitor sympathetic activity as estimated using heart rate variability analysis). Measurements will be performed at Catharina Hospital Eindhoven, the Netherlands (NL), where patients undergo elective cardiac surgery. Using the data obtained, we will 1) establish and quantify the in vivo contractility of the human thoracic aorta, and 2) study whether and to which extent potential predictors (age, sex, smoking status, antihypertensive medication use/class, mean arterial pressure, pulse pressure as an indirect measure of arterial stiffness, diabetes, chronic kidney disease, total cholesterol, and sympathetic activity) influence contractility conditions: Human Thoracic Aorta Contractility studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 98 type: ESTIMATED name: Phenylephrine measure: To establish and quantify the in vivo contractility of the human thoracic aorta measure: To quantify the magnitude of contractile response measure: To study whether and to which extent potential predictors influence contractility. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Catharina hospital city: Eindhoven state: Noord-Brabant zip: 5623 EJ country: Netherlands name: Frederique de Raat, Msc. role: CONTACT phone: +31615137244 email: [email protected] name: Angélique Burmanje, Msc. role: CONTACT phone: +316 44 15 00 18 email: [email protected] lat: 51.44083 lon: 5.47778 hasResults: False |
<|newrecord|> nctId: NCT06374823 id: IIT2023-020-002 briefTitle: Multiple Electrolytes Injection (II) and Normal Saline on Hyperchloremia in Severe Hemorrhagic Stroke acronym: MERIT overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-12 date: 2026-12 date: 2024-04-19 date: 2024-04-19 name: Capital Medical University class: OTHER briefSummary: Normal saline (0.9% sodium chloride), a classical crystalloid solution, is widely used to maintain fluid balance, volume resuscitation and dilute drugs during clinical practice. However, the chloride concentration of normal saline (154mmol/L) is much higher than human plasma, and a large amount of infusion may lead to iatrogenic hyperchloremia in ICU patients. In contrast, the concentrations of Multiple electrolytes II is more similar to those of plasma and is considered to be a better fluid choice than normal saline. conditions: Critical Care conditions: Hyperchloremia conditions: Hemorrhagic Stroke studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 342 type: ESTIMATED name: Multiple Electrolyte name: Normal Saline measure: Hyperchloremia measure: Hyperchloremia acidosis measure: Plasma osmolality measure: AKI measure: RRT measure: hospital length of stay measure: ICU length of stay measure: hospitalization expense sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Beijing Shijitan Hospital city: Beijing state: Beijing zip: 100038 country: China name: Jian-Xin Zhou, MD role: CONTACT phone: +8613801183875 email: [email protected] lat: 39.9075 lon: 116.39723 hasResults: False |
<|newrecord|> nctId: NCT06374810 id: CCB1 briefTitle: Does Conscious Connected Breathwork Reduce Symptoms of Anxiety? overallStatus: COMPLETED date: 2023-09-21 date: 2023-12-20 date: 2023-12-20 date: 2024-04-19 date: 2024-04-22 name: Richard Blake class: OTHER briefSummary: The goal of this clinical trial is to test whether conscious connected breathwork reduces symptoms of anxiety in people with mild to severe anxiety symptoms, as measured by the Zung Self Rating Anxiety Scale. |
The main questions aims to answer: |
1. Does conscious connected breathwork reduce symptoms of anxiety? |
2. Does an increased frequency of self-practice lead to even greater reductions of anxiety symptoms. |
there is a comparison group: Researchers will compare whether people doing the breathwork to see if \[insert effects\]. |
Participants will participate in 1, 90 minute breath workshop per week for 6 weeks. These sessions will be held on Zoom by 2 facilitators. Participants will also be given a 10 minute recording of a guided conscious connected breathwork session that they will be encouraged to complete daily. conditions: Anxiety studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Participants were randomly assigned to either the breathwork group or they were told that they had been placed on a waitlist and that they would participate in the 2nd cohort, which would take place after the 1st 6-week program had been completed. |
Participants in the breathwork groups were also given a 10 minute guided conscious connected breathwork recording. They were advised to do this daily to support the integration of their process. This was not mandatory. At the end of the study participants were asked how often they used the guided self-practice. The frequency of use of the self-practice was used a covariate. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Participants in group 2 were told that the trial was full but actually they were just placed in the placebo control group. whoMasked: PARTICIPANT count: 108 type: ACTUAL name: Conscious Connected Breathwork name: Placebo waitlist measure: Changes in anxiety symptoms sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CIIS city: San Francisco state: California zip: 94103 country: United States lat: 37.77493 lon: -122.41942 hasResults: False |
<|newrecord|> nctId: NCT06374797 id: CMZ-207 briefTitle: A Study of Auxora in Patients With AKI and Injurious Lung "Crosstalk" acronym: KOURAGE overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-08 date: 2025-08 date: 2024-04-19 date: 2024-04-19 name: CalciMedica, Inc. class: INDUSTRY briefSummary: Approximately 150 patients with acute kidney injury (AKI) associated with acute hypoxemic respiratory failure (AHRF) will be randomized at up to 40 sites. Patients will be randomly assigned to either Auxora or matching placebo. Study drug infusions will occur every 24 hours for five consecutive days for a total of five infusions. conditions: Acute Kidney Injury studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 150 type: ESTIMATED name: Auxora name: Placebo measure: Days alive, ventilator-free and kidney replacement therapy (KRT)-free from SFISD through Day 30 measure: Major adverse kidney event (MAKE) 90-1: ≥25% decline in estimated glomerular filtration rate (eGFR) from baseline, incident KRT, and all-cause mortality at 90 days measure: MAKE 90-2: ≥35% decline in eGFR from baseline, incident KRT, and all-cause mortality at 90 days measure: Proportion of patients alive at Day 30 measure: Proportion of patients alive at Day 90 measure: Days alive and ventilator-free from start of first infusion of study drug (SFISD) through Day 30 measure: Days alive and KRT-free from SFISD through Day 30 measure: Proportion of patients recovered from AHRF through Day 30 as categorized by an 8-point ordinal scale measure: Proportion of patients receiving KRT at Day 30 measure: Proportion of patients receiving KRT at Day 90 measure: Number of patients with treatment-related adverse events (TEAE) measure: Number of patients with grade 3 TEAEs measure: Days alive and not hospitalized through Day 30 measure: Proportion of patients re-hospitalized through Day 30 measure: Proportion of patients re-hospitalized through Day 90 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06374784 id: perio2023ARP briefTitle: Autogenous Demineralized Dentin Graft Combined With Injectable PRF + Metronidazole Versus Autogenous Demineralized Dentin Graft Combined With Injectable PRF Versus Autogenous Demineralized Dentin Graft Alone for Alveolar Ridge Preservation overallStatus: NOT_YET_RECRUITING date: 2024-04-20 date: 2024-10-20 date: 2024-11-20 date: 2024-04-19 date: 2024-04-23 name: Cairo University class: OTHER briefSummary: The aim of this trial is to compare the effect of autogenous demineralized dentin graft combined with injectable PRF loaded with metronidazole (sticky demineralized tooth releasing metronidazole) versus autogenous demineralized dentin graft combined with injectable PRF (sticky demineralized tooth) versus autogenous demineralized dentin graft (ADDG) alone on alveolar ridge preservation after extraction of non restorable, infected single-rooted teeth conditions: Alveolar Bone Loss studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: Alveolar ridge preservation using autogenous demineralized dentin graft combined with injectable PRF loaded with metronidazole name: Alveolar ridge preservation using autogenous demineralized dentin graft combined with injectable PRF name: Alveolar ridge preservation using autogenous demineralized dentin graft alone measure: Alveolar ridge apico-coronal height change in mm measure: Alveolar ridge bucco-lingual width change in mm measure: Histological assessment sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Faculty of Dentistry city: Cairo country: Egypt name: Cairo University role: CONTACT lat: 30.06263 lon: 31.24967 hasResults: False |
<|newrecord|> nctId: NCT06374771 id: MD-15-2022 briefTitle: Analgesic Effect of Melatonin and Vitamin C Administration, Alone or In Combination in Major Abdominal Surgery. overallStatus: NOT_YET_RECRUITING date: 2024-04-27 date: 2024-06-27 date: 2024-07-10 date: 2024-04-19 date: 2024-04-19 name: Cairo University class: OTHER name: Theodor Bilharz Research Institute briefSummary: The goal of this clinical trial is to compare the analgesic effect of melatonin, and vitamin C and their combination in patients aged 18-60 years old who will undergo major abdominal surgery with mid-line incision within an expected time of surgery from 3 to 5 hours e.g. radical cystectomy, radical prostatectomy, colectomy, sigmoidectomy, splenectomy, and CBD exploration through mid-line incision. |
This study hypothesizes that using both vitamin C and melatonin together as adjuvants will cause: |
* More reduction in total morphine consumption in the first 24 hours postoperatively |
* More reduction of the incidence of chronic post-surgical pain, than using each adjuvant alone. |
Participants will be allocated into three equal groups: Melatonin (M group) and vitamin C (V group), and Melatonin and vitamin C (VM group). Two hours before surgery all patients will receive the study drugs orally and will be continued for 3 days postoperative at the same time of the first administration; 10mg of melatonin for M group (Melatonin 10 mg - Puritan's Pride premium company), 1gm of vitamin C for V group (Sanso C 1000 mg - AUG pharma company), and 10mg of melatonin and 1gm of vitamin C for VM group. |
Researchers will compare: |
* The effect of melatonin, vitamin C, and their combination on postoperative opioid consumption |
* The severity of postoperative pain, using the Numerical Rating Scale (NRS) |
* Patients' satisfaction with a three-point scale |
* The time of the first requirement for rescue analgesia |
* The effect on the incidence of chronic post-surgical pain. conditions: Postoperative Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Melatonin 10 MG name: Vitamin C measure: Total morphine consumption measure: Numeric Rating Scale measure: Richmond Agitation Sedation Scale measure: Time to first analgesic request measure: chronic post-surgical pain measure: patient satisfaction using Likert three-point scale measure: systolic blood pressure measure: Heart rate measure: Intra-operative mean consumption of sevoflurane per hour. sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Faculty of Medicine - Cairo University city: Cairo state: Manial zip: 11553 country: Egypt name: Waleed Hamimy, MD role: CONTACT phone: 01150377770 phoneExt: +2 email: [email protected] lat: 30.06263 lon: 31.24967 hasResults: False |
<|newrecord|> nctId: NCT06374758 id: MU-2096449 briefTitle: Accelerated ART Initiation for PWHIV Who Are Out of Care acronym: ACCELERATE overallStatus: RECRUITING date: 2024-05-01 date: 2025-05-01 date: 2025-11-01 date: 2024-04-19 date: 2024-04-19 name: University of Missouri-Columbia class: OTHER name: Gilead Sciences briefSummary: The main purpose of the study is to evaluate the effectiveness, of the ACCELERATE model of care to achieve HIV viral suppression at Week 24. The study will also assess the acceptability, appropriateness, feasibility, and sustainability of the ACCELERATE model of care. The ACCELERATE model combines a standardized method for outreach, the use of telehealth for rapid access to an HIV care provider, a simplified pre-approved HIV regimen, a free 30-day medication starter supply, and re-linkage to medical care. conditions: HIV Infections conditions: ART conditions: Noncompliance, Patient studyType: INTERVENTIONAL phases: PHASE4 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 120 type: ESTIMATED name: The Accelerate model of care name: bictegravir/emtricitabine/tenofovir alafenamide 50/200/25 mg measure: The effectiveness of the ACCELERATE model of care to achieve HIV viral suppression at Week 24. measure: To study the change over time in the acceptability of the ACCELERATE model of care in patient and staff participants. measure: To study the change over time in appropriateness of the ACCELERATE model of care in patient and staff participants measure: To study the change over time in feasibility of the ACCELERATE model of care in patient and staff participants measure: To study the change over time in sustainability of the ACCELERATE model of care in patient and staff participants measure: Qualitative data measure: To evaluate the effectiveness of the intervention to achieve HIV viral suppression at week 48 using ACCELERATE model of care. measure: To assess change in patient experience (PROs) and satisfaction for participants using the ACCELERATE model of care measure: To assess change in health-related quality of life (HRQoL) measure: To measure the change in patients' satisfaction with the HIV treatment regimen B/F/TAF measure: To measure Retention in Care measure: To assess the adherence to the study treatment measure: To study the virologic response of using B/F/TAF as first line regimen in ACCELERATE model of care. measure: To study the immunologic response of using B/F/TAF as first line regimen in ACCELERATE model of care. measure: To assess staff impact of ACCELERATE model of care on staff satisfaction measure: To assess staff impact of ACCELERATE model of care on staff burnout sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Missouri-Columbia status: RECRUITING city: Columbia state: Missouri zip: 65212 country: United States name: Dima Dandachi, MD role: CONTACT phone: 573-884-8728 email: [email protected] lat: 38.95171 lon: -92.33407 hasResults: False |
<|newrecord|> nctId: NCT06374745 id: 2020-01307; mu24Kappos briefTitle: An Integrated Algorithm for Surgical Intervention in Chronic Lymphedema After Breast Cancer Treatment: The Basel Lymphedema Protocol overallStatus: RECRUITING date: 2015-01-02 date: 2024-12-30 date: 2024-12-30 date: 2024-04-19 date: 2024-04-19 name: University Hospital, Basel, Switzerland class: OTHER name: Sana Kliniken Düsseldorf GmbH briefSummary: The primary objective of the investigators is to develop an integrated algorithm for surgical treatment of chronic lymphedema after breast cancer surgery. This will be achieved by retrospectively analysing a subgroup of patients who had breast cancer-related surgery prior to lymphedema. conditions: Lymphedema conditions: Breast Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 500 type: ESTIMATED measure: To design an integrated algorithm for surgical treatment of chronic lymphedema after breast cancer surgery. measure: Date of follow-up procedure measure: Follow-up and type of lymphedema surgery measure: Circumferences of the affected and unaffected side measure: Postoperative complications measure: Surgery duration. measure: Type of lymphedema surgery measure: Date of lymphedema surgery measure: Use of compression stockings measure: Number of lymphedema drainages per week measure: Stage of lymphedema measure: Duration of lymphedema measure: Location of lymphedema measure: Subsequent cancer treatment measure: Date of cancer related surgery measure: Tumor staging measure: Tumor location measure: BMI measure: Comorbidities measure: Age measure: Gender measure: Analysis of cohort subgroups: all patients who had surgery related to any kind of cancer prior to their lymphedema measure: Analysis of cohort subgroups: all patients who had surgery related to a specific kind of cancer prior to their lymphedema, e.g. vulvar, cervical or uterine cancer measure: Analysis of cohort subgroups: all patients who had no history of cancer and thus no cancer-related surgery in their medical history measure: Analysis of cohort subgroups: all patients with chronic lymphedema regardless of whether or not they have an oncological history measure: Analysis of cohort subgroups: all patients who underwent DIEP flap or TRAM flap or LDM flap or implant based breast reconstruction or BCS measure: Analysis of cohort subgroups: exploratory sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital Basel status: RECRUITING city: Basel zip: 4031 country: Switzerland name: Elisabeth A Kappos, PD Dr. med. role: CONTACT phone: 0041 61 265 25 25 email: [email protected] name: Adriano Fabi, BMed role: CONTACT phone: 0041 79 888 12 51 email: [email protected] lat: 47.55839 lon: 7.57327 hasResults: False |
<|newrecord|> nctId: NCT06374732 id: TY2024002 briefTitle: The Benefits of a High-intensity Interval Training Intervention Delivered in a School Setting Among Adolescents overallStatus: RECRUITING date: 2024-02-26 date: 2024-10-01 date: 2024-10-01 date: 2024-04-19 date: 2024-04-19 name: University of Exeter class: OTHER name: China Scholarship Council name: Ningbo University briefSummary: A 12-week school-based high-intensity interval training intervention, with 8 classes of year 7 students randomly allocated to either intervention or control group. The interval training sessions will last for 6 to 10 minutes and will be delivered 5 times per week. Outcome variables will be physical activity, body composition, cardiorespiratory fitness, muscular strength, bone health, executive function, mental wellbeing, and academic performance, which will be measured pre- and post-intervention and two months after the intervention has been completed. conditions: Healthy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 400 type: ESTIMATED name: High-intensity interval training name: Control group measure: Cardiorespiratory fitness measure: Muscular strength measure: Wellbeing measure: Enjoyment measure: Motivation measure: Affect measure: Academic performance measure: Height measure: Weight measure: BMI measure: Waist circumference measure: Body fat percentage measure: Physical activity measure: Bone health measure: Perceived physical ability measure: Flanker task measure: Visual 2-back task measure: Colour-shape switch task measure: Confounding variables measure: Interview sex: ALL minimumAge: 11 Years maximumAge: 13 Years stdAges: CHILD facility: University of Exeter status: RECRUITING city: Exeter state: Devon zip: EX1 2LU country: United Kingdom name: Yong Liu role: CONTACT phone: +447570013632 email: [email protected] role: CONTACT phoneExt: Liu email: [email protected] name: yong Liu role: PRINCIPAL_INVESTIGATOR lat: 50.7236 lon: -3.52751 hasResults: False |
<|newrecord|> nctId: NCT06374719 id: WiTNNess briefTitle: WiTNNess - TNNT1 Myopathy Natural History Study acronym: WiTNNess overallStatus: RECRUITING date: 2018-09-23 date: 2027-01-01 date: 2027-06-01 date: 2024-04-19 date: 2024-04-19 name: Clinic for Special Children class: OTHER briefSummary: WiTNNess is designed to accurately document the natural course and variation of muscle disease caused by pathogenic changes of the TNNT1 gene. The primary aim of the study is to specify meaningful outcome measures for future clinical trials. WiTNNess is open to children and adults worldwide. Participants can choose to include their information once (cross-sectional cohort) or every few months (prospective cohort). conditions: TNNT1-associated Myopathy conditions: Infantile-onset Nemaline Rod Myopathy conditions: Myopathies, Nemaline conditions: Myopathy conditions: Myopathy, Rod conditions: Myopathy; Hereditary conditions: Amish Nemaline Myopathy conditions: Nemaline Myopathy 5 conditions: NEM5 conditions: Genetic Muscle Disease conditions: Recessive Hereditary Disorder (Autosomal) conditions: ANM studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 40 type: ESTIMATED measure: Event-free survival measure: Motor Milestones measure: Thriving sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Clinic for Special Children status: RECRUITING city: Strasburg state: Pennsylvania zip: 17579 country: United States name: Joelle FS Williamson, MPH role: CONTACT phone: 717-687-9407 email: [email protected] lat: 39.98316 lon: -76.18412 hasResults: False |
<|newrecord|> nctId: NCT06374706 id: 23-0129 briefTitle: Effects of End-Effector Type Rehabilitation Robots-Morning Walk on Symmetrical Walking Patterns in Individuals With Hemiparesis overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-04-01 date: 2025-08-30 date: 2024-04-19 date: 2024-04-19 name: The University of Texas Medical Branch, Galveston class: OTHER briefSummary: In this study, our objective is to explore and evaluate interventions to improve the process of recovery following a stroke. The main focus is on enhancing symmetrical walking patterns in adults who have experienced neurological deficits due to a stroke. The primary tool will be an end-effector type rehabilitation robot, the Morning Walk®. This robot has been specifically designed to assist in enhancing symmetrical walking patterns for individuals recovering from a stroke Morning Walk® has received approval from the FDA, meaning it meets stringent safety and efficacy standards. conditions: Stroke conditions: Healthy Volunteers studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 40 type: ESTIMATED name: Morning Walk training for stroke name: Morning Walk training for healthy measure: The Number of Participants with Kinematic representation of the temporal events during end-effector robot training measure: Muscle Activity in the lower extremities measure: Spatiotemporal Patterns of Walking, Speeds measure: Spatiotemporal Patterns of Walking, Parameters sex: ALL minimumAge: 20 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Texas Medical Branch city: Galveston state: Texas zip: 77555 country: United States name: Mansoo Ko, Ph.D. role: CONTACT phone: 409-772-9555 email: [email protected] name: Judith L Linton, MS role: CONTACT phone: 4092661767 email: [email protected] lat: 29.30135 lon: -94.7977 hasResults: False |
<|newrecord|> nctId: NCT06374693 id: STH22772 briefTitle: Investigating the Tolerability and Feasibility of Transcutaneous Vagus Nerve Stimulation Following Aneurysmal Subarachnoid Haemorrhage acronym: tVNS in aSAH overallStatus: NOT_YET_RECRUITING date: 2024-04-14 date: 2025-08 date: 2025-08 date: 2024-04-19 date: 2024-04-19 name: Sheffield Teaching Hospitals NHS Foundation Trust class: OTHER briefSummary: After a subarachnoid haemorrhage, complications are common and increase the overall rate of disability and death from the condition. Despite some advances in preventing, detecting and treating these complications, the rates of complications and associated risks remain high. Further research into ways to reduce complications of subarachnoid haemorrhage. |
Transcutaneous vagus nerve stimulation (tVNS) is a technique where a small handheld device is attached to an earpiece which stimulates the nerves to the ear. This is given for short periods and may help improve blood flow and reduce inflammation in the brain. The intervention has been safely used and licensed in seizures, headache and severe depression. |
This study will look to see if it is feasible and tolerable to have tVNS twice daily for 5 days after subarachnoid haemorrhage, and whether it can help reduce the risk of complications from subarachnoid haemorrhage. |
The participant will be randomly allocated to receive either tVNS or a dummy intervention, known as sham. |
The researchers will collect some personal and clinical details such as diagnosis, medications, age, blood test results, as well as some details about the subarachnoid haemorrhage. |
The researchers will also complete brief questionnaires with the participant to assess symptoms. They will take measurements of heart rate, pupil response, and brain activity using a cap. The participant will then be randomly allocated to either receive the tVNS or sham intervention. |
Next, the research team will apply the earpiece to their ear twice a day for 45 minutes, for a total of 5 days. |
At the end of the 5-day study period, the intervention will be complete. The researchers will arrange a follow-up meeting on discharge and at 6 weeks, to assess the participants symptoms and recovery. |
Previous studies have shown that tVNS is safe and well tolerated, including a recent review of tVNS studies which evaluated the side effects experienced by 1322 patients receiving tVNS. |
The main side effects include localised tingling/numbness/pain/redness around the ear (17%), headaches (3%), dizziness (1%), facial droop (1%), nausea (1%), nasal discharge (2%). Rarely, palpitations or a slow heart rate may occur. |
They will continue to receive full medical treatment and observation alongside the study. They are free to withdraw from this study if they find it too demanding on top of their other activities. conditions: Subarachnoid Haemorrhage From Cerebral Aneurism Rupture studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: Transcutaneous Vagus Nerve Stimulation name: Sham Transcutaneous Vagus Nerve Stimulation measure: Monitor tolerability for tVNS measure: Assess study feasibility measure: Monitor safety criteria for tVNS measure: Rates of delayed cerebral ischaemia (DCI) measure: Inpatient mortality measure: Length of inpatient stay measure: Rates of inpatient complications measure: Modified rankin score measure: Barthel Index measure: Inflammatory markers measure: Headache scores measure: Cerebral functional near-infrared spectroscopy measure: Heart rate variability measure: Pupillary light reactivity sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Sheffield city: Sheffield state: South Yorkshire zip: S10 2HQ country: United Kingdom name: Dr Ali Ali role: CONTACT phone: +4401142159114 email: [email protected] name: Mr Matthew Myers role: SUB_INVESTIGATOR lat: 53.38297 lon: -1.4659 typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2023-12-16 uploadDate: 2024-01-12T08:49 filename: Prot_000.pdf size: 2294124 hasResults: False |
<|newrecord|> nctId: NCT06374680 id: C3 ectomy briefTitle: C3 Laminectomy With Cervical Laminoplasty overallStatus: WITHDRAWN date: 2017-03-20 date: 2021-12-31 date: 2021-12-31 date: 2024-04-19 date: 2024-04-22 name: Seoul National University Hospital class: OTHER briefSummary: 1. Background In cervical stenosis, cervical laminoplasty from the third to sixth cervical vertebrae is widely used. However, the muscles attached to the C2, which play an important role in the movement of our neck, are frequently damaged during the C3 laminoplasty. In contrast, cervical spine surgery through the removal of the C3 is thought to give less damage to the muscles attached to the C2. |
2. Purpose The aim of this study was to compare the prospective randomized comparison of these two surgical methods. |
3. Hypothesis There is no difference in the cervical length and overall cervical angle between 1 month, 3 months, 6 months, and 12 months postoperatively between C3 laminectomy with C4-6 laminoplasty and C3-6 laminoplasty. conditions: Neck Pain studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 0 type: ACTUAL name: laminectomy at C3 level measure: neck pain sex: ALL minimumAge: 20 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Seoul National University Hospital city: Seoul zip: 110-744 country: Korea, Republic of lat: 37.566 lon: 126.9784 hasResults: False |
<|newrecord|> nctId: NCT06374667 id: KY2024-071-02 briefTitle: The Efficacy and Safety of Y-3 Intracalvariosseous Injection Versus Intravenous Injection in the Treatment of Acute Large Hemispheric Infarction acronym: SOLUTION-2 overallStatus: RECRUITING date: 2024-04-22 date: 2025-09-15 date: 2026-03-15 date: 2024-04-18 date: 2024-04-26 name: yilong Wang class: OTHER briefSummary: A pilot study confirmed the feasibility and safety of neuroprotectant Y-3 intracalvariosseous(ICO) injection in patients with malignant middle cerebral artery infarction (mMCAI), showing a trend in improving 90-day functional scores compared to conventional treatment. The aim of this trial is to further investigate the efficacy and safety of ICO injection of Y-3 compared to intravenous injection in patients with acute large hemispheric infarction(LHI) who has contraindications of reperfusion therapy or have got poor reperfusion therapy outcomes. conditions: Stroke, Acute Ischemic conditions: Blood-Brain Barrier studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Y-3 ICO injection name: Y-3 intravenous injection name: Conventional treatment measure: 90-day favorable clinical outcome measure: Change of infarct volume from baseline to 8-day measure: Neurofunctional deficit defined as the National Institutes of Health Stroke Scale (NIHSS) . measure: Patients with symptoms improvement from baseline to 14-day measure: Rate of decompressive hemicraniectomy measure: Depression scale scores at 90-day measure: Proportion of combined adverse events at 90-day sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The first affiliated hospital of Wannan Medical College status: NOT_YET_RECRUITING city: Wuhu state: Anhui country: China name: Shoucai Zhao, MD role: CONTACT name: Zhenbao Li, MD role: CONTACT lat: 31.33728 lon: 118.37351 facility: Beijing Tiantan Hospital status: RECRUITING city: Beijing state: Beijing zip: 100050 country: China name: Yilong Wang, PhD，MD role: CONTACT email: [email protected] lat: 39.9075 lon: 116.39723 facility: Tangshan Municipal Worker's Hospital status: NOT_YET_RECRUITING city: Tangshan state: Heibei country: China name: Jun Hong, MD role: CONTACT lat: 39.63333 lon: 118.18333 facility: Shaanxi Provincial People's Hospital status: NOT_YET_RECRUITING city: Xi'an state: Shaanxi country: China name: Wei Hu, MD role: CONTACT lat: 34.25833 lon: 108.92861 hasResults: False |
<|newrecord|> nctId: NCT06374654 id: 2023P003272 briefTitle: RCT of Home-based vs Formal Physical Therapy for Treatment of New Onset Non-insertional Achilles Tendinopathy overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-04 date: 2026-04 date: 2024-04-18 date: 2024-04-18 name: Brigham and Women's Hospital class: OTHER briefSummary: The goal of this prospective randomized controlled trial is to compare the effectiveness of a home-based exercise protocol to formal physical therapy in patients who have been diagnosed with Achilles tendinopathy. The null hypothesis is that there will be no difference in the treatment outcomes between patients with Achilles tendinopathy who participate in a home-based program versus patients with Achilles tendinopathy who undergo formal physical therapy. Participants will be randomized to a 12-week home-based or formal physical therapy protocol and asked to complete brief outcomes surveys at their initial visit, and at 6 weeks, 12 weeks, 6 months, and 1 year after their initial visit. conditions: Achilles Tendinopathy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 56 type: ESTIMATED name: Home-based Exercise Protocol name: Formal Physical Therapy measure: Victorian Institute of Sports Assessment self-administered Achilles questionnaire (VISA-A) measure: PROMIS Pain Interference (4a) measure: PROMIS Pain Intensity (3a) measure: PROMIS Depression (4a) measure: Patient Acceptable Symptom State Questionnaire sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Brigham and Women's Hospital city: Boston state: Massachusetts zip: 02130 country: United States lat: 42.35843 lon: -71.05977 hasResults: False |
<|newrecord|> nctId: NCT06374641 id: 5514255 briefTitle: The Effects of a Novel Mitochondrial Substrate Supplement on Exercise Performance and Cognitive Function acronym: MCh1 overallStatus: RECRUITING date: 2024-03-26 date: 2025-04 date: 2025-08 date: 2024-04-18 date: 2024-04-18 name: University of Exeter class: OTHER name: Mitocholine Ltd name: Innovate UK briefSummary: The goal of this clinical trial is to compare the effects of taking a new supplement for 16 days on cognitive function and exercise performance, compared to a placebo (a supplement that looks and tastes the same, but doesn't have the same ingredients) in 40 healthy individuals - 20 young individuals (aged 18-30) and 20 older individuals (aged 50-65). |
The main questions it aims to answer are: |
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