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<|newrecord|> nctId: NCT06388070 id: HUC3-053 briefTitle: To Evaluate the Efficacy and Safety of HUC3-053 in Patients With Dry Eye Syndrome overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-03 date: 2025-04 date: 2024-04-29 date: 2024-04-29 name: Huons Co., Ltd. class: INDUSTRY briefSummary: This is a multi-center, randomized, double-blinded, non-inferiority study to evluate the efficacy and safety of HUC3-053 in patients with dry eye syndrome. |
After a 2-week run-in period, patients will be randomized equally to the HUC3-053 or Hyalein Mini Drops administered bilaterally five to six times a day for 12 weeks. conditions: Dry Eye Syndromes studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 280 type: ESTIMATED name: HUC3-053 name: Hyalein Mini Drops measure: Change from Baseline in Corneal staining score measure: Change from Baseline in Corneal staining score measure: Change from Baseline in Conjunctival staining score measure: Change from Baseline in Schirmer test measure: Change from Baseline in Tear film break-up time measure: Change from Baseline in Ocular surface disease index measure: Change from Baseline in Soreness after eye drop assessed by NRS sex: ALL minimumAge: 19 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06388057 id: 5836 briefTitle: Intraoperative Ultrasound in Crohn's Disease overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-06-30 date: 2025-09-01 date: 2024-04-29 date: 2024-04-29 name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS class: OTHER briefSummary: To study the role of intraoperative ultrasound of small bowel as a possible tool that can reduce the rate of histologically involved resection margins from Crohn's Disease. conditions: Crohn Disease studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Patients with Crohn's disease with an indication for surgery primaryPurpose: DIAGNOSTIC masking: NONE count: 100 type: ESTIMATED name: Intraoperative Small Bowel Ultrasonography measure: Specificity and sensibility of intraoperative ultrasound of small bowel in identifying resection margins histologically involved by Crohn's disease sex: ALL minimumAge: 12 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06388044 id: PRO00115010 briefTitle: ACT for Infertility: Case Series overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-04 date: 2025-04 date: 2024-04-29 date: 2024-04-29 name: Duke University class: OTHER briefSummary: In the United States, around 19% of reproductive-aged couples suffer from infertility. The psychological distress associated with infertility is well-established; those diagnosed commonly experience depression and anxiety symptoms, diminished quality of life, and relationship dissatisfaction. In the current study, the investigators report on a case series, in which up to 10 infertility patients will receive 12 sessions of Acceptance and Commitment Therapy (ACT). The overarching goal for the current case series is to determine whether ACT might be well-suited for infertility patients experiencing distress. The specific aims are: 1) to describe the components of the intervention that was delivered; 2) to determine the extent to which infertility patients perceive a 12-session ACT intervention beneficial and acceptable; 3) to describe change in mood, stress, and ACT processes across 12 sessions of ACT; and 4) to highlight potential processes through which ACT might promote benefits to the patient by describing how change in mood, stress, and ACT processes relate to each other over the course of 12 sessions of ACT. conditions: Infertility conditions: Psychological Distress conditions: Acceptance and Commitment Therapy conditions: Psychological Flexibility studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: Acceptance and Commitment Therapy measure: Acceptability of the Intervention measure: Change in Fertility Problem Inventory (FPI) measure: Change in Patient Health Questionnaire 9 (PHQ-9) measure: Change in Patient Health Questionnaire 2 (PHQ-2) measure: Change in Generalized Anxiety Disorder Questionnaire 7 (GAD-7) measure: Change in Generalized Anxiety Disorder Questionnaire 2 (GAD-2) measure: Change in Modified Differential Emotions Scale (mDES) measure: Change in Comprehensive Assessment of Acceptance and Commitment Therapy (CompACT-15) measure: Change in Intolerance of Uncertainty (IUS) measure: Change in Valuing Questionnaire (VQ) measure: Change in Values-Based Behavior sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Duke North Pavilion city: Durham state: North Carolina zip: 27705 country: United States name: Francesca Scheiber, PhD role: CONTACT phone: 919-668-8696 email: [email protected] name: Julia Woodward, PhD role: SUB_INVESTIGATOR name: Ashley Moskovich, PhD role: SUB_INVESTIGATOR lat: 35.99403 lon: -78.89862 hasResults: False |
<|newrecord|> nctId: NCT06388031 id: CAPTRAL2024v1 briefTitle: ICI Rechallenge for Advanced NSCLC With Long-Term Response to First-Line ICI overallStatus: NOT_YET_RECRUITING date: 2024-05-10 date: 2027-01-10 date: 2027-12-10 date: 2024-04-29 date: 2024-04-29 name: Peking Union Medical College Hospital class: OTHER briefSummary: An exploratory phase II trial of immune checkpoint inhibitors (ICIs, anti-PD-1/anti-PD-L1) as second-line treatment with advanced non-small cell lung cancer (NSCLC) who had long-term response to first-line immunotherapy (with or without chemotherapy). |
This study aims to evaluate efficacy and safety of ICI rechallenge in long-term responders to prior ICI. Furthermore, it seeks to identify biomarkers capable of predicting the efficacy of immunotherapy and prognosis. conditions: Non-small Cell Lung Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 27 type: ESTIMATED name: Immune checkpoint inhibitor measure: Progression Free Survival (PFS) measure: Overall Survival (OS) measure: Objective Response Rate (ORR) measure: Progression Free Survival 2 (PFS 2) measure: Safety profile sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Peking Union Medical College Hospital city: Beijing zip: 100730 country: China lat: 39.9075 lon: 116.39723 hasResults: False |
<|newrecord|> nctId: NCT06388018 id: NRG-GY032 id: NCI-2023-09355 type: REGISTRY domain: CTRP id: CCTG EN.10 type: OTHER domain: CCTG id: U10CA180868 type: NIH link: https://reporter.nih.gov/quickSearch/U10CA180868 briefTitle: Tailoring Therapy in Post-surgical Patients With Low-risk Endometrial Cancer overallStatus: SUSPENDED date: 2024-04-16 date: 2025-01-09 date: 2025-01-09 date: 2024-04-29 date: 2024-04-29 name: NRG Oncology class: OTHER name: National Cancer Institute (NCI) name: Canadian Cancer Trials Group briefSummary: This phase II trial tests how well tailoring therapy in post-surgery works in patients with low-risk endometrial cancer. The usual approach for patients with low-risk endometrial cancer is treatment with surgery. In this study, tissue that is removed as part of the surgical procedure is analyzed in the pathology laboratory to help guide the doctor to decide whether or not additional treatment such as radiation and or chemotherapy should be recommended. conditions: Stage I Uterine Corpus Endometrial Stromal Sarcoma AJCC V8 conditions: Stage II Uterine Corpus Endometrial Stromal Sarcoma AJCC V8 conditions: Stage III Uterine Corpus Endometrial Stromal Sarcoma AJCC V8 studyType: INTERVENTIONAL phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 325 type: ESTIMATED name: Clinical Observation name: External Beam Radiation Therapy name: High-Dose-Rate Vaginal Brachytherapy name: Computed Tomography name: Positron Emission Tomography name: X-Ray Imaging name: Magnetic Resonance Imaging name: Questionnaire Administration measure: Time to pelvic recurrence measure: Time to isolated vaginal recurrence measure: Recurrence-free survival measure: Endometrial cancer-specific survival measure: Fear of recurrence sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Washington University School of Medicine city: Saint Louis state: Missouri zip: 63110 country: United States lat: 38.62727 lon: -90.19789 hasResults: False |
<|newrecord|> nctId: NCT06388005 id: 2021-060 briefTitle: The Application of Emotion Release Technology in Anxiety Patients Before Daytime Thyroid Surgery overallStatus: COMPLETED date: 2022-03-01 date: 2022-07-31 date: 2022-07-31 date: 2024-04-29 date: 2024-04-29 name: Yantai Yuhuangding Hospital class: OTHER briefSummary: Research methods |
1 Data collection and evaluation tools |
1. The general data record sheet was self-designed by the research team, and the collected content included age, gender, BMI, occupation, general family status, economic situation, history of hypertension and cardiovascular diseases, history of anxiety and depression, self-rating anxiety scale (SAS) score, blood pressure and heart rate before and after intervention, disease diagnosis and severity, etc. |
2. The anxiety was self-scored using the VAS-A (0-10 points), with 0 point as no anxiety and 10 as severe anxiety. |
3. Negative emotional intensity was scored using the subjective unit of disturbance scale (SUDS, 0-10 points), with 0 point as no and 10 points as severe. |
4. Nursing satisfaction was scored by the self-designed questionnaire (1-5 points): 5 points, very satisfied; 4 points, relatively satisfied; 3 points, satisfied; 2 points, medium; 1 point, dissatisfied. |
2 Intervention method of the control group The control group was given routine nursing. After entering the pre-anesthesia room, the patients were scored using the VAS-A, and those with VAS-A score ≥ 5 were considered to meet the inclusion criteria. After identity authentication, the preoperative precautions and reasons for waiting in the pre-anesthesia room were explained to the patients, and answers were provided to the questions raised by the patients. After routine nursing, VAS-A score was recorded, blood pressure and heart rate were monitored, and nursing satisfaction was inquired. The survey of patient satisfaction with nursing was completed before entering the operating room. |
3 Intervention method of the experimental group 3.1 Researcher training Before intervention, 4 nurses were trained for 5 d by a nurse with EFT qualification certificate, 1 h per day. The training content included: theoretical knowledge of EFT, tapping techniques, etc. After training, two assessments were conducted. Only those who scored above 90 points in both assessments could participate in the study. |
3.2 Operating instructions The acupoint diagram was distributed to the experimental group by nurses, and the essentials and precautions of acupoint tapping were explained. The nurses demonstrated and tapped the acupoints on the patients while explaining, and then instructed them to tap on their own until they were able to complete the task independently and proficiently. For patients with upper limb vein puncture, proper fixation and close observation were needed, and the flexible nature of the puncture needle that would not affect operations was explained to the patients to eliminate their concerns. |
3.3 Intervention content After routine nursing, the patients received EFT intervention. In addition, subjective anxiety was scored, blood pressure and heart rate were monitored, and nursing satisfaction was surveyed after admission and intervention. The specific methods are as follows. |
1. Preparation stage The patients with VAS-A score ≥ 5 meeting the inclusion criteria were in a comfortable position with eyes closed, and adopted breathing exercise to relax their whole body. The patients were guided to summarize the main current distresses, such as fear, tension, pain, surgical prognosis, economic burden, etc., name the caused negative emotions, and use the SUDS to evaluate the intensity of negative emotions. The patients were asked to recite silently the prompt "Although I am very \*\* (a negative emotional word) now, I still deeply and completely love and accept myself" while tapping. |
2. Tapping stage The patients were guided to gently massage the sore points on both sides of the body (2-3 fingers below the midpoint of the clavicle) with their five fingers together in a clockwise direction, while silently reciting the prompt 3 times. Then, the patients were guided to close their index and middle fingers together and gently tap the Zanzhu, Tongziliao, Chengqi, Renzhong, Chengjiang, Shufu, Dabao and Baihui acupoints successively with their fingertips at 2-3 times/s and the force they can bear. The prompt was recited silently when tapping each acupoint. After 3-5 rounds of tapping, 3 deep breaths were taken to re-evaluate the intensity of negative emotions. |
3. Feedback stage After tapping, the patients communicated with the nurses at least once about their evaluated negative emotional intensity score and whether the score was accepted. If the tapping effect was not obvious, the evaluation was conducted by nurses, and the patients were guided to massage the sore points while silently reciting the prompt 3 times. To relieve reverse psychological drive, tapping was continued until the intensity of negative emotions reduced. conditions: Anxiety conditions: Day Surgery conditions: Preoperative Nursing Care conditions: Emotional Freedom Technique studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 237 type: ACTUAL name: emotional freedom technique (EFT) measure: VAS-A score measure: hemodynamic and endocrine indicators measure: nursing satisfaction sex: ALL minimumAge: 18 Years maximumAge: 64 Years stdAges: ADULT facility: Yantai Yuhuangding Hospital city: Yantai state: Shandong zip: 264000 country: China lat: 37.47649 lon: 121.44081 hasResults: False |
<|newrecord|> nctId: NCT06387992 id: PP24023 briefTitle: Evaluation of the Agreement Between a Consultation With a Nurse Acquiring Three-dimensional Intraoral Images Made With a 3D Intraoral Camera and the Standard Consultation With a Dental Surgeon, in Institutionalized Elderly Subjects acronym: GEROdonto3D overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2027-06-01 date: 2027-06 date: 2024-04-29 date: 2024-04-29 name: CHU de Reims class: OTHER briefSummary: The primary objective of this study will be to assess the agreement between a dental consultation with a nurse acquiring intraoral images, using a 3D intraoral camera, and a standard consultation with a dental surgeon, in institutionalized elderly subjects Institutionalized subjects planned to have a dental consultation and eligible will be included once written informed consent is signed. Their dental consultation will start with a consultation with a nurse to record 3D intraoral images, then a consultation with a dental surgeon for standard dental care, blinded from the nurse consultation will be performed. Thereafter, 3D images will be analyzed by another dental surgeon blinded from the results of both consultations. Agreement on different outcomes between the analysis of the images acquired by the nurse and the standard dental evaluation by a dental surgeon will be assessed. |
Agreement on the results between the interpretation of the 3D images acquired by a nurse and the standard consultation by a dental surgeon could lead, in the long term, to a significant step forward in dental care of institutionalized patients. |
Indeed, training nursing home nurses to acquire 3D dental images would enable the identification of patients in need of immediate dental care and thus extend the possibilities of access to consultations with a dentist for these patients. This would increase the efficiency of care. conditions: Dental Care for Institutionalized Elderly Persons studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 50 type: ESTIMATED name: Three-dimensional dental acquisition measure: DMFT index measure: Plaque control record measure: General Oral Health Assessment Index (GOHAI) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Damien JOLLY city: Reims country: France name: Carole ETIENNOT role: CONTACT phone: 03 10 73 66 79 phoneExt: 0033 email: [email protected] lat: 49.25 lon: 4.03333 hasResults: False |
<|newrecord|> nctId: NCT06387979 id: 19-010725 id: NCI-2024-01000 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: 19-010725 type: OTHER domain: Mayo Clinic in Florida id: P30CA015083 type: NIH link: https://reporter.nih.gov/quickSearch/P30CA015083 id: R33CA240181 type: NIH link: https://reporter.nih.gov/quickSearch/R33CA240181 briefTitle: Advanced Development of Desorption Electrospray Ionization Mass Spectrometry for Intraoperative Molecular Diagnosis of Brain Cancer Using Pathology Biopsies overallStatus: RECRUITING date: 2020-10-26 date: 2025-10-15 date: 2025-10-15 date: 2024-04-29 date: 2024-04-29 name: Mayo Clinic class: OTHER name: National Cancer Institute (NCI) briefSummary: This study explores whether DESI-MS can be used to identify cancerous vs. noncancerous tissue during brain tumor surgery. conditions: Glioma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 185 type: ESTIMATED name: Non-Interventional Study measure: Pathological state of the tissue measure: Percentage of tumor infiltration measure: Presence of IDH mutations sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mayo Clinic in Florida status: RECRUITING city: Jacksonville state: Florida zip: 32224-9980 country: United States name: Clinical Trials Referral Office role: CONTACT phone: 855-776-0015 email: [email protected] name: Alfredo Quinones-Hinojosa, M.D. role: PRINCIPAL_INVESTIGATOR lat: 30.33218 lon: -81.65565 hasResults: False |
<|newrecord|> nctId: NCT06387966 id: H-FNTN-PI-Ia briefTitle: A Randomized, Double-blind,Dose-escalating, Single-dose, Oral Phase I Clinical Study of Flunotinib Healthy People overallStatus: RECRUITING date: 2024-02-29 date: 2024-08-29 date: 2024-12-30 date: 2024-04-29 date: 2024-04-29 name: Chengdu Zenitar Biomedical Technology Co., Ltd class: INDUSTRY briefSummary: Evaluate the safety and tolerability of a single increasing dose of Flibanserin Maleate tablets administered orally to healthy adult Chinese subjects; preliminarily assess the pharmacokinetic characteristics of a single dose of oral Flibanserin Maleate tablets conditions: Healthy Person studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: flunotinib name: flunotinib placebo measure: Prilinostat Mesylate Pharmacokinetics (PK):Cmax measure: Prilinostat Mesylate Pharmacokinetics (PK):Tmax measure: The statistical parameters of fecal pharmacokinetics are the cumulative excretion of prototype drugs and major metabolites in feces (Ae0-144h) and excretion rate (Ae%); measure: Prilinostat Mesylate Pharmacokinetics (PK):AUC0-∞ measure: Prilinostat Mesylate Pharmacokinetics (PK):MRT measure: Prilinostat Mesylate Pharmacokinetics (PK):Vd measure: Prilinostat Mesylate Pharmacokinetics (PK):t1/2 measure: Prilinostat Mesylate Pharmacokinetics (PK):CLz/F measure: Prilinostat Mesylate Pharmacokinetics (PK):Vz/F measure: Prilinostat Mesylate Pharmacokinetics (PK):Ke sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Chengdu Xinhua Hospital status: RECRUITING city: Chengdu state: Sichuan zip: 610000 country: China name: Xiaolan Yong, bachelor role: CONTACT phone: 13568843829 email: [email protected] lat: 30.66667 lon: 104.06667 hasResults: False |
<|newrecord|> nctId: NCT06387953 id: STUDY00019480 briefTitle: Mitigation of Emergence Agitation Through Implementation of Masimo Bridge Therapy overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-06 date: 2025-06 date: 2024-04-29 date: 2024-04-29 name: University of Washington class: OTHER briefSummary: This is a randomized, prospective, double-blinded (patient and outcome-assessor) trial. Our goal is to assess efficacy of Bridge Therapy (versus sham bridge therapy) to prevent emergence agitation following general anesthesia. |
Primary Objective: Activation of Bridge Therapy from the time of the pre incision "time out" until 24 hours after admission to the PACU (Post Anesthesia Care Unit) is associated with reduced frequency and intensity of emergence agitation. |
Secondary Objective: Bridge Therapy activation will also result in a lower incidence of rescue pharmacologic treatment of agitation. |
Tertiary Objective: Activation of Bridge Therapy during a stable anesthetic state is associated with a reduced Patient State Index as measured on Sedline conditions: Emergence Delirium conditions: Agitation, Emergence studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 50 type: ESTIMATED name: Bridge Therapy name: Sham Therapy measure: Emergence agitation measure: Emergence agitation measure: Rescue pharmacologic treatment of agitation measure: Patient State Index sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06387940 id: UEC 2019 008 FHMS briefTitle: Acute Metabolic Effects of Carbohydrate Restriction at Varying Energy Levels overallStatus: COMPLETED date: 2019-11-05 date: 2020-04-01 date: 2022-11-20 date: 2024-04-29 date: 2024-04-29 name: University of Surrey class: OTHER briefSummary: This study investigates how different low-carbohydrate diets affect metabolism and hunger in overweight adults. We will measure metabolic rates and blood metabolites. conditions: Healthy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 12 type: ACTUAL name: nEB Diet, followed for 36 hours name: LC25 Diet, followed for 36 hours name: LCEB Diet, followed for 36 hours measure: Biomarkers in blood Measured measure: Resting metabolic rate measure: Perceived Appetite Scores measure: Food intake sex: ALL minimumAge: 20 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Surrey city: Guildford zip: GU2 7XH country: United Kingdom lat: 51.23536 lon: -0.57427 hasResults: False |
<|newrecord|> nctId: NCT06387927 id: PT-NEUR-10/2023-520 briefTitle: Effect of Home-exercise Programs Versus Supervised Core Stability Exercises on Hypertensive Patient With Low Back Pain overallStatus: COMPLETED date: 2023-09-02 date: 2024-02-02 date: 2024-02-20 date: 2024-04-29 date: 2024-04-29 name: Ahram Canadian University class: OTHER briefSummary: Thirty male and female hypertension patients with chronic mechanical non-specific low back pain were included in this randomized controlled study conducted at the Ababa Private Physical Therapy Center in Beni-Seuf, Egypt. They were randomly assigned into two equal groups; the study group A control (n = 15) had a supervised conventional core stability, while the study group B (n = 15) received a home exercise program. In both groups' patients had evaluations before and after their six-week course of therapy. Modified-modified Schober test was used to assess the active back range of motion (ROM), Arabic version of Oswestry disability index (ODI) was utilized to evaluate functional disability, and visual analog scale (VAS) was used to measure pain. conditions: Hypertension conditions: Low Back Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 30 type: ACTUAL name: home exercise program name: the core stability exercise measure: Assessment of pain measure: Assessment of lumbar flexion range of motion measure: Assessment of functional disability sex: ALL minimumAge: 30 Years maximumAge: 50 Years stdAges: ADULT facility: Faculty of physical therapy city: Giza zip: 3387722 country: Egypt lat: 30.00808 lon: 31.21093 hasResults: False |
<|newrecord|> nctId: NCT06387914 id: PID 16707 id: 23/WM/0219 type: OTHER domain: Ethics Committee (South Birmingham REC) UK briefTitle: Efficacy of Pain Intervention With Deep Brain Stimulation Neuromodulation acronym: EPIONE overallStatus: NOT_YET_RECRUITING date: 2024-05-02 date: 2026-05-02 date: 2027-05-02 date: 2024-04-29 date: 2024-04-29 name: University of Oxford class: OTHER name: Jon MoultonTrust name: Placito Bequest name: Bioinduction briefSummary: The goal of this clinical trial is to learn if deep brain stimulation (DBS) works to treat severe pain following a stroke in adults. It will also learn about the safety of deep brain stimulation. The main questions it aims to answer are: |
* Does DBS lower the pain score in these participants. |
* What medical problems do participants have when having DBS? Researchers will compare different settings, to see if DBS works to treat severe post stroke pain. |
Participants will: |
* Undergo baseline screening procedures and have an MRI scan. |
* Have neurosurgery to put the DBS system in |
* Have follow up for 10 months |
* Visit the clinic at least 5 times in the study for check-ups and tests |
* Fill in questionnaires about pain and mood and have check ups remotely conditions: Central Post Stroke Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Double-blind trial, within subject randomisation and cross-over. primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: Blinding maintained using the hand held controller (shows ON at all times) and programs which ensure equivalent battery drain at all stimulation settings. |
Pseudo-ON =high frequency, low amplitude stimulation. Frequency up to 250 Hertz(Hz), Amplitude less than 0.5 milliamps(mA), Pulse Width 500 microseconds(uS). whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: Stimulation ON name: Stimulation Pseudo-ON measure: McGill Pain Questionnaire V2.0 -Short Form - Present Pain Intensity (MQ-SF-PPI) score measure: Numerical Rating Scale (NRS) measure: McGill Pain Questionnaire V2.0 short form (MPQ-SF) McGill Pain Questionnaire V2.0 short form) MPQ-SF (McGill Pain Questionnaire V2.0 short form) measure: Brief Pain Inventory (BPI) - Short Form measure: Beck Depression Inventory (BDI II) measure: Patients' Global Impression of Change (PGIC) measure: EuroQol Quality of life (EQ5D-5L) measure: Healthy Days Measures (HDM) measure: Adverse Events (AEs) measure: Heart rate variability (HRV) measure: Client Service Receipt Inventory (CSRI) measure: MRI sex: ALL minimumAge: 21 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06387901 id: PABTOX - part 1 briefTitle: Investigating Paclitaxel Toxicity in Breast Cancer: The Roles of Physical Activity and Body Composition. acronym: PABTOX overallStatus: NOT_YET_RECRUITING date: 2024-05-06 date: 2025-05-06 date: 2025-10-31 date: 2024-04-29 date: 2024-04-29 name: Universitair Ziekenhuis Brussel class: OTHER name: Vrije Universiteit Brussel name: University Ghent briefSummary: This study looks into how a common breast cancer treatment, paclitaxel, can sometimes cause severe side effects that make it hard for patients to continue treatment. These side effects can significantly affect a patient's quality of life and even impact their recovery and overall health costs. What's interesting about this research is that it considers how a patient's lifestyle, specifically their physical activity levels and body makeup (like how much muscle and fat they have), might influence these side effects. |
The researchers are doing a detailed study with 40 women receiving paclitaxel treatment, tracking how the drug is processed in their bodies and how their body composition and physical activity might play a role in the side effects they experience. They are using a special method to monitor drug levels in the blood and are also keeping tabs on the patients' health and physical activity through questionnaires and modern tracking devices. |
The goal here is twofold: first, to better understand why these side effects happen to some people and not others, and second, to develop a model that can predict who might be at higher risk for these side effects based on their body composition, lifestyle, and how their body handles the drug. This could lead to more personalized treatment plans that could help reduce the risk of severe side effects and improve the overall treatment experience for patients with breast cancer. |
In simpler terms, this research is trying to find a way to make breast cancer treatment with paclitaxel safer and more comfortable by considering how a person's lifestyle and body type might affect their reaction to the drug. This could make a big difference in helping patients complete their treatment successfully and with a better quality of life. conditions: Breast Cancer conditions: Paclitaxel Adverse Reaction conditions: Chemotherapeutic Toxicity conditions: Chemotherapeutic Agent Toxicity conditions: Body Weight conditions: Physical Inactivity studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 40 type: ESTIMATED name: Paclitaxel Chemotherapy measure: Identification of Body Composition Parameter (Muscle mass) Related to Dose-Limiting Toxicities (DLTs) measure: Identification of Body Composition Parameters (Fat %) Related to Dose-Limiting Toxicities (DLTs) measure: Identification of Physical Activity Parameters Related to Dose-Limiting Toxicities (DLTs) measure: Paclitaxel Exposure Analysis (Cmax) measure: Paclitaxel Exposure Analysis (AUC) measure: Number and Type of Dose-Limiting Toxicities measure: Treatment-Related Adverse Events measure: Body Composition Measurement via Bioelectrical Impedance Analysis (BIA) (muscle mass) measure: Body Composition Measurement via Bioelectrical Impedance Analysis (BIA) (fat %) measure: Body Composition Measurement via Dual X-ray Absorptiometry (DEXA) (muscle mass) measure: Body Composition Measurement via Dual X-ray Absorptiometry (DEXA) (fat mass) measure: Body Composition Measurement via Dual X-ray Absorptiometry (DEXA) (extracellular fluid) measure: The European Organization for Research and Treatment of Cancer quality of life questionnaire (EORTC QLQ-C30) measure: EORTC QLQ-BR45 Breast (BR) Cancer Module measure: EORTC QLQ- Chemotherapy-Induced Peripheral Neuropathy (CIPN) 20 measure: European Health Interview Survey Physical Activity Questionnaire (EHIS PAQ) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Vrije Universiteit Brussel city: Brussel state: Jette zip: 1090 country: Belgium name: Nele Adriaenssens role: CONTACT phone: +32 2 476 36 23 email: [email protected] name: Len De Nys role: CONTACT phone: +32 472 99 49 48 email: [email protected] lat: 50.85045 lon: 4.34878 hasResults: False |
<|newrecord|> nctId: NCT06387888 id: E-31034136-302.08.01-4221 briefTitle: The Effect of Mother's Voice on the Levels of Pain and Comfort in Newborns acronym: Newborn overallStatus: COMPLETED date: 2021-07-01 date: 2021-09-01 date: 2022-04-30 date: 2024-04-29 date: 2024-04-29 name: Istanbul Medipol University Hospital class: OTHER briefSummary: This study was conducted in a randomized controlled experimental type to determine the effect of maternal voice during care on pain and comfort level in term newborns receiving mechanical ventilation. The sample of the study was consisted of 60 term newborns receiving mechanical ventilation who were hospitalized in the 7-bed Neonatal Intensive Care Unit of a private hospital in Istanbul in accordance with the selection criteria. Introductory Information Form, Vital Signs Follow-up Form, Neonatal Comfort Behavior Scale and Neonatal Pain Scale (NPASS) forms prepared by the researchers were used as data collection tools. conditions: Newborns studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: INVESTIGATOR count: 60 type: ACTUAL name: Listening to mother's voice measure: Neonatal Comfort Behavior Scale measure: Neonatal Comfort Behavior Scale (COMFORTneo): sex: ALL minimumAge: 3 Weeks maximumAge: 41 Weeks stdAges: CHILD facility: Istanbul Medipol University Hospital city: Istanbul state: Beykoz country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False |
<|newrecord|> nctId: NCT06387875 id: Hangzhou Bay Cohort briefTitle: Cohort in Qianwan New District, Ningbo overallStatus: RECRUITING date: 2023-11-01 date: 2027-06-30 date: 2027-06-30 date: 2024-04-29 date: 2024-04-29 name: RenJi Hospital class: OTHER name: Ningbo Hangzhou Bay Hospital briefSummary: Our objective is to carry out research on prevention and control of noncommunicable chronic diseases, and establish a risk prediction mechanism for chronic diseases to promote early detection, early diagnosis and early treatment of chronic diseases in natural population in Qianwan District of Ningbo, significantly reduce medical costs and extend population life span. conditions: Cardiovascular Diseases conditions: Stroke conditions: Non-Communicable Chronic Diseases studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 30000 type: ESTIMATED measure: death measure: incidence of cardio-cerebrovascular diseases measure: incidence of other non-communicable chronic diseases sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ren Ji Hospital Afflited to School of Medicine, Shanghai Jiao Tong University status: RECRUITING city: Shanghai country: China name: Jun Pu, MD,PHD role: CONTACT phone: 86-21-68383477 email: [email protected] lat: 31.22222 lon: 121.45806 hasResults: False |
<|newrecord|> nctId: NCT06387862 id: 2022SIMBIOV briefTitle: Pharmacokinetics of Inhaled Levosimendan acronym: Symbiov overallStatus: NOT_YET_RECRUITING date: 2024-04-20 date: 2024-11 date: 2025-01 date: 2024-04-29 date: 2024-04-29 name: Universitair Ziekenhuis Brussel class: OTHER briefSummary: Determination of biological availability, time-to-peak and elimination half-life of inhaled levosimendan by administration of an inhaled- and intravenous dose of levosimendan. conditions: Left Ventricular Dysfunction studyType: INTERVENTIONAL phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: BASIC_SCIENCE masking: NONE count: 6 type: ESTIMATED name: Levosimendan 2.5 milligram/milliliter Injectable Solutiondose Inhaled name: Levosimendan 2.5 milligram/milliliter Injectable Solutiondose Intravenous measure: Bioavailability of inhaled levosimendan measure: Time-to-peak of inhaled levosimendan measure: Elimination half-life of inhaled levosimenan measure: Effect of inhaled levosimendan on MAP measure: Effect of inhaled levosimendan on TVR measure: Effect of inhaled levosimendan on CO measure: Effect of inhaled levosimendan on LVOT VTI measure: Effect of inhaled levosimendan on FAC of the right vetricle measure: Effect of inhaled levosimendan on S' measure: Effect of inhaled levosimendan on SPAP sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UZ Brussel city: Brussel zip: 1090 country: Belgium name: Matthias Raes, MD role: CONTACT phone: 024749872 email: [email protected] name: Marie-Claire Van Malderen, SC role: CONTACT phone: 024763110 email: [email protected] lat: 50.85045 lon: 4.34878 hasResults: False |
<|newrecord|> nctId: NCT06387849 id: 03/2023 briefTitle: Aromatherapy Effect on Pain and Anxiety After C-section overallStatus: COMPLETED date: 2023-04-21 date: 2023-08-31 date: 2023-08-31 date: 2024-04-29 date: 2024-04-29 name: University Tunis El Manar class: OTHER briefSummary: A prospective randomized triple blinded study conducted in the obstetrics gynecology department of Ben Arous hospital over a period of four months and 10 days between April 2023 and August 2023. |
The aim of this study was to evaluate the effectiveness of lavender aromatherapy on postoperative pain and anxiety after cesarean section under spinal anesthesia in Tunisian women. conditions: Post-operative Pain conditions: Post-operative Anxiety studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 100 type: ACTUAL name: Aromatherapy name: Placebo measure: Post-operative pain level measure: Post-operative anxiety level measure: Heart Rate (HR) measure: Systolic Blood Pressure (SBP) measure: Diastolic Blood Pressure (DBP) measure: Respiratory Rate (RR) measure: Pulsatile Oxygen Saturation sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Ben Arous Regional Hospital city: Ben Arous country: Tunisia lat: 36.75306 lon: 10.21889 hasResults: False |
<|newrecord|> nctId: NCT06387836 id: B2024-063 briefTitle: LINC01844 as a Diagnostic Biomarker for POCD in Elderly Patients overallStatus: RECRUITING date: 2024-02-21 date: 2025-02-21 date: 2025-06-30 date: 2024-04-29 date: 2024-04-29 name: Shanghai Zhongshan Hospital class: OTHER briefSummary: Postoperative cognitive dysfunction (POCD) is a common complication after surgery that is associated with more adverse events and death. The goal of this observational study is to learn about the diagnosis performance of long intergenic non-coding RNA(LINC01844) level in blood of older people for POCD. The main question it aims to answer is: |
Does the relative level of LINC01844 in blood help diagnose POCD of older people after surgery? Participants undergoing elective lumbar decompression and fusion will finish neuropsychological evaluations one day before and 1st, 3rd and 5th day after surgery. At the same timepoint, the relative level of LINC01844 in blood will also be tested. conditions: Postoperative Cognitive Dysfunction studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 63 type: ESTIMATED measure: relative level of LINC01844 measure: serum reactive protein-C measure: serum interleukin-6 sex: ALL minimumAge: 65 Years maximumAge: 85 Years stdAges: OLDER_ADULT facility: Zhongshan Hospital Fudan University status: RECRUITING city: Shanghai state: Shanghai zip: 200032 country: China name: Danfeng Jin, M.D. role: CONTACT phone: +8613795306154 email: [email protected] name: Shengjin Ge, Ph.D. role: CONTACT phone: +8613601926171 email: [email protected] name: Shengjin Ge, Ph.D. role: PRINCIPAL_INVESTIGATOR lat: 31.22222 lon: 121.45806 hasResults: False |
<|newrecord|> nctId: NCT06387823 id: K5321 briefTitle: Efficacy and Safety of Sivelestat Sodium and Dexamethasone in the Treatment of ARDS acronym: STAR overallStatus: NOT_YET_RECRUITING date: 2024-04-27 date: 2025-06-01 date: 2025-09-01 date: 2024-04-29 date: 2024-04-29 name: Peking Union Medical College Hospital class: OTHER name: Peking University name: Shanghai Huilun Pharmaceutical Co., Ltd. briefSummary: The goal of this clinical trial is to evaluate the efficacy and safety of Sivelestat sodium and dexamethasone in the treatment of patients with moderate to severe ARDS. The main questions it aims to answer are: |
* Is Sivelestat sodium more effective in the treatment of patients with moderate to severe ARDS compared with placebo? |
* Is dexamethasone more effective in the treatment of patients with moderate to severe ARDS compared with placebo? Participants will receive Sivelestat sodium, dexamethasone or placebo. Researchers will compare the efficacy and safety of Sivelestat sodium, dexamethasone and placebo. conditions: Acute Respiratory Distress Syndrome studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 300 type: ESTIMATED name: Sivelestat sodium name: Dexamethasone name: Sivelestat sodium placebo name: Dexamethasone placebo measure: 28-day ventilator-free days measure: Informed consent rate measure: Recruitment rate measure: Recruitment compliance rate measure: Protocol adherence rate measure: Completion of follow-up visits measure: 28-day mortality measure: 90-day mortality measure: 28-day length of stay measure: 28-day organ support free day measure: Sequential organ failure assessment (SOFA) measure: Murray's acute lung injury score measure: C-reactive protein (CRP) measure: Interleukin-6 (IL-6) measure: Interleukin-8 (IL-8) measure: Procalcitonin (PCT) measure: Neutrophil-to-lymphocyte Ratio (NLR) measure: Neutrophil elastase measure: New-onset infection rate measure: Re-intubation rate measure: Adverse event sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06387810 id: MA-PC-II-010 briefTitle: Irinotecan Liposome II in Combination With 5-FU/LV and Oxaliplatin in Perioperative Treatment of Borderline Resectable Pancreatic Cancer acronym: undetermined overallStatus: NOT_YET_RECRUITING date: 2024-04-17 date: 2026-04-30 date: 2026-06-30 date: 2024-04-29 date: 2024-04-29 name: Peking Union Medical College Hospital class: OTHER briefSummary: This is a prospective, single-arm, phase II study to evaluate the efficacy and safety of irinotecan liposome II in combination with oxaliplatin and 5-FU/LV in perioperative treatment of borderline resectable pancreatic cancer in 45 patients. conditions: Borderline Resectable Pancreatic Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 45 type: ESTIMATED name: irinotecan liposome II combined with 5-FU/LV and oxaliplatin measure: event free survival measure: overall survival measure: R0 resection rate measure: R1 excision rate measure: adverse event sex: ALL minimumAge: 18 Years maximumAge: 110 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06387797 id: UNLV-2023-321 briefTitle: Primary and Secondary Prevention of Type 2 Diabetes Mellitus in Clark County overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-05-30 date: 2025-05-31 date: 2024-04-29 date: 2024-04-29 name: University of Nevada, Las Vegas class: OTHER name: University of Nevada, Reno briefSummary: This pilot and feasibility study aims to assess the effectiveness of a nutrition education intervention using the Cooking Matters for Adults Curriculum (SNAP-Ed). The study compares this standard curriculum with an enhanced version that includes the same curriculum but has additional components, incorporating specific information related to type 2 diabetes. Additionally, participants in the enhanced group will receive continuous glucose monitors to wear during the study for 10 days. The primary outcomes of the study include evaluating the acceptability of the intervention, and the feasibility of conducting the intervention at the UNLV Nutrition Center. The investigators will also assess participants' Knowledge, Attitudes, and Intentions regarding produce consumption. Alongside feasibility and acceptability, the study aims to explore the preliminary effectiveness of the intervention in increasing fruit and vegetable consumption, reducing HbA1c, managing cardiometabolic risk, and improving gut microbiome composition and diversity among participants in the program. The investigators will also assess changes in other lifestyle behaviors from baseline to post-intervention (6 weeks) (sleep, stress, physical activity, and sedentary behavior). conditions: At Risk for Type 2 Diabetes Mellitus conditions: Pre Diabetes studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants will be randomized to one of two parallel study arms. |
1. Cooking Matters for Adults (CMA) Curriculum Delivery over 6 weeks |
2. CMA + Enhanced cooking classes with added components comprising cooking practices specific to diabetes prevention, online information as well as short assignments and activities regarding sleep, stress, physical activity, and sedentary behaviors. The CMA+ arm will also have the opportunity to use a continuous glucose monitor (CGM) for 10 days immediately following the baseline assessment visit. This will be an optional component and participants will not be excluded if they do not wish to use the CGM. (6 weeks) primaryPurpose: PREVENTION masking: SINGLE maskingDescription: Because of the parallel arm differences, it would not be possible to mask the arm assignment for the participant or investigator. However, we will mask the arm assignment for the outcomes assessor, in particular for the HbA1c% assessment. whoMasked: OUTCOMES_ASSESSOR count: 120 type: ESTIMATED name: Cooking Matters for Adults (CMA+) name: Cooking Matters for Adults (CMA) measure: Feasibility of conducting the intervention measure: Acceptability of the intervention measure: Acceptability of each cooking class measure: Knowledge about the importance of produce consumption measure: Attitudes toward produce consumption measure: Intentions to consume recommended amounts of produce during and after intervention measure: Changes in fruit and vegetable consumption in servings per day measure: HbA1c% measure: Body weight in kg measure: Gut Microbiota composition measure: waist circumference in cm measure: body fat percentage (%) measure: non fat mass in kg measure: blood pressure in mmHg measure: fasting blood glucose in mg/dL measure: fasting total cholesterol in mg/dL measure: fasting LDL cholesterol in mg/dL measure: fasting HDL cholesterol in mg/dL measure: fasting triglyceride level in mg/dL measure: Usual dietary quality measure: Week 6 dietary quality measure: physical activity energy expenditure average kcals per day measure: Time spent in sedentary behavior in minutes per day measure: physical activity intensity distribution as minutes per day and average percentage of day measure: sleep quantity in hours per day measure: sleep quality measure: stress levels measure: Nutrition Security sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Nevada, Las Vegas city: Las Vegas state: Nevada zip: 89154 country: United States name: Sara K Rosenkranz, PhD role: CONTACT phone: 702-895-0938 email: [email protected] name: Richard Rosenkranz, PhD role: CONTACT phone: 702-895-5198 email: [email protected] name: Keren Morales, B.S., RD role: SUB_INVESTIGATOR name: Donya Shahamati, B.S. role: SUB_INVESTIGATOR name: Laura Kruskall, PhD, RD role: SUB_INVESTIGATOR name: Elika Nematian, M.S. role: SUB_INVESTIGATOR lat: 36.17497 lon: -115.13722 hasResults: False |
<|newrecord|> nctId: NCT06387784 id: 2024/823 briefTitle: Acute Beetroot Juice Supplementation in Pre-eclampsia Pregnancies acronym: BEET_PE overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2024-12 date: 2025-06 date: 2024-04-29 date: 2024-04-29 name: University of Sao Paulo class: OTHER name: Hospital das Clínicas de Ribeirão Preto name: Universidade Estadual Paulista Júlio de Mesquita Filho briefSummary: Pre-eclampsia is a serious condition that typically affects pregnant women after the 20th week of pregnancy, characterized by high blood pressure and damage to organs such as the kidneys and liver. Currently, treatment options are limited, which has prompted researchers to explore alternative approaches. One such promising alternative is dietary nitrate found in vegetables like beetroot, as nitrate can be converted into nitric oxide in the body, which helps lower blood pressure. This study aims to determine the acute effects of nitrate-rich beetroot juice on blood pressure, several blood and salivary markers in pregnant women with pre-eclampsia. Furthermore, the study will assess fetal blood flow using Doppler ultrasound. The investigators want to understand the kinetics of nitrate and nitric oxide metabolites and assess the temporal dependency of the hypotensive response. Through this investigation, the investigators seek evidence of nitrate-enriched beetroot juice as an adjunct therapy in managing pre-eclampsia. conditions: Pre-Eclampsia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized, placebo-controlled, single-blind, parallel-group study assessing acute rich-nitrate juice on pregnant women diagnosed with early and late-onset pre-eclampsia. Participants will be divided into four distinct groups: two groups for each onset category. Within each group, participants will be further divided into a control group and a treated group. The assignment of participants to these groups will be randomized using an online program. primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 96 type: ESTIMATED name: Beetroot juice name: Placebo juice measure: Acute Effect of Beetroot Juice Supplementation on Blood Pressure measure: Plasma Concentrations of Nitric Oxide Metabolites measure: Concentration of Salivary Nitrate Reductase Enzyme measure: Plasma Lipid Peroxidation Levels measure: Concentration of Total Antioxidant Capacity in Plasma measure: Maternal Blood Flow Velocity measure: Fetal Heart Rate measure: Umbilical Arterial Pulsatility Index sex: FEMALE minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT hasResults: False |
<|newrecord|> nctId: NCT06387771 id: rs4680-tolcapona briefTitle: Evaluation of Tolcapone as a Cognitive Enhancer in Schizophrenia overallStatus: RECRUITING date: 2014-09-22 date: 2025-08 date: 2024-04-29 date: 2024-04-29 name: Clinica Universidad de Navarra, Universidad de Navarra class: OTHER briefSummary: Objective: To assess the efficacy of tolcapone to improve cognition in schizophrenia, as a genotype-based targeted treatment of cognitive and negative symptoms of schizophrenia considering the polymorphism rs4680. |
Methodology: 20 patients with chronic and stabilized schizophrenia (10 patients with genotype Val/Val and 10 patients with genotype Met/Met according to polymorphism rs4680) will receive treatment with tolcapone during 7 days. The cognitive function and clinical status will be evaluated with a neuropsychological battery and appropriate clinical scales before and after treatment. The efficiency of the activation of the prefrontal cortex will be measured using functional magnetic resonance imaging (fMRI) before and after treatment. |
Hypothesis: Only patients with genotype Val/Val treated with tolcapone would show a cognitive improvement, a higher efficiency of the activation of the prefrontal cortex and an amelioration of some negative symptoms. conditions: Schizophrenia studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: Tolcapone measure: Efficacy: Change from baseline in cognitive test scores at day 8 measure: Efficacy: Change from baseline in the brain blood-oxygen-level-dependent (BOLD) response at day 8 measure: Efficacy: change from baseline in psychotic symptoms intensity measured by the PANSS scores at day 8 measure: Efficacy: negative symptoms intensity: change from baseline in the 16-item Negative Symptom Assessment (NSA-16) scale scores at day 8 measure: Efficacy: change from baseline in the intensity of psychotic symptoms measured by the Brief Psychiatric Rating Scale (BPRS) scores at day 8 measure: Efficacy: change from baseline in the clinical global impression measured by the Clinical Global Impression (CGI) scale scores at day 8 measure: Efficacy: change from baseline in the global assessment of functioning measured by the Global Assessment of Functioning (GAF) scale scores at day 8 measure: Efficacy: change from baseline in the anxiety symptoms measured by the Hamilton Anxiety Rating Scale (HAM-A) scale scores at day 8 measure: Efficacy: change from baseline in the depressive symptoms measured by the Hamilton Depression Rating Scale (HAM-D) scale scores at day 8 measure: Efficacy: change from baseline in the Clinician-Rated Dimensions of Psychosis Symptom Severity (CRDPSS) scale scores at day 8 measure: Change from baseline in plasmatic homocysteine (umol/L) measure: Patient Reported Outcome: change from baseline in the Profile of Mood States (POMS) scores at day 8 measure: Patient Reported Outcome: change from baseline in the mood state Visual Analogue Scale (VAS) scores at day 8 sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Clinica Universidad de Navarra status: RECRUITING city: Pamplona state: Navarra zip: 31008 country: Spain name: Jose Maria Galindo role: CONTACT phone: 34 948 255400 phoneExt: 2725 email: [email protected] lat: 42.81687 lon: -1.64323 hasResults: False |
<|newrecord|> nctId: NCT06387758 id: UMMC-IRB-2022-473 briefTitle: Low Systemic/High Local Exercise Load in Peds SCD overallStatus: RECRUITING date: 2023-09-19 date: 2025-06-30 date: 2025-06-30 date: 2024-04-29 date: 2024-04-29 name: University of Mississippi Medical Center class: OTHER name: University of Alabama at Birmingham briefSummary: This research study wants to learn about what kind of exercise is best for kids with sickle cell disease. Participating children will have a small amount of blood drawn one time at the beginning of the study. Children will then complete some questionnaires that measure pain, physical function, and emotions (depression, anxiety) and complete some tests that measure physical fitness at the beginning and end of the study. Children will be randomized to either a home-based telehealth (1) walking or (2) strengthening exercise program that lasts for 8-weeks, 3-x week, for 45 minutes each session. Children's participation will last up to 10 weeks. conditions: Sickle Cell Anemia in Children studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: FACTORIAL primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: Low systemic strength training name: Moderate systemic exercise measure: Demographics and medical history (parents) measure: Pediatric Pain Questionnaire measure: Functional Disability Inventory measure: NIH PROMIS 2582 measure: Heart Rate Variability measure: Heart Rate measure: Blood Pressure measure: Bruininks-Oseretsky Test of Motor Proficiency measure: American Thoracic Society 6-minute walk test measure: Actigraphy measure: Daily diaries measure: Biomarkers measure: Medical Chart Review sex: ALL minimumAge: 12 Years maximumAge: 17 Years stdAges: CHILD facility: University of Mississippi Medical Center status: RECRUITING city: Jackson state: Mississippi zip: 39216 country: United States name: Cynthia Karlson, PhD role: CONTACT phone: 601-984-2723 email: [email protected] lat: 32.29876 lon: -90.18481 hasResults: False |
<|newrecord|> nctId: NCT06387745 id: US-REFERRAL briefTitle: Referral of Patients to Hepatology With Hepatoscope acronym: US-REFERRAL overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-12 date: 2025-12 date: 2024-04-29 date: 2024-04-29 name: University Hospital, Antwerp class: OTHER name: E-Scopics briefSummary: Patients identified as being at risk of liver fibrosis because of a positive Fibrosis-4 (FIB-4) test in the primary care setting will be offered be enrolled in the trial and to undergo an Hepatoscope exam (external non-invasive ultrasound imaging exam) to screen for liver fibrosis (with stiffness measurements) and/or steatosis (with ultrasound parameters related to fatty liver). All patients presenting with a liver stiffness value of at least 6.5 kilopascal (kPa) will be referred to the tertiary hepatology consultations for further assessment. Hepatoscope measurements will be compared to the standard of care for these patients, as defined at the tertiary hepatology center. conditions: Chronic Liver Disease studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SCREENING masking: NONE count: 200 type: ESTIMATED name: Hepatoscope measure: Positive Predictive Value for significant fibrosis measure: Correlation of stiffness measurements measure: Concordance of stiffness measurements measure: Diagnostic performance of liver stiffness measurements sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06387732 id: 161223 briefTitle: Mechanisms Underlying Antidepressant Effects of Physical Activity acronym: LIFE overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2027-08 date: 2028-01 date: 2024-04-29 date: 2024-04-29 name: University College, London class: OTHER name: King's College London name: Queen Mary University of London name: University of Dublin, Trinity College briefSummary: It is well established that any level of physical activity can help prevent and treat depression, with more strenuous activity having a greater effect. Understanding the mechanisms driving this antidepressant effect is important because it could allow exercise programmes to be made more effective, accessible, and targeted. Such knowledge could contribute to social prescribing, increasingly a priority for mental healthcare. Importantly, physical activity is highly scalable, low cost, well suited to early intervention, and has beneficial impacts on physical health co-morbidities. This trial may provide initial indications of whether there are sub-groups of depressed individuals who are particularly likely to benefit from physical activity, lead to strategies to personalise physical activity prescription based on motivational factors, and pave the way for augmentative approaches, for example combining physical activity with psychological interventions. |
To date the mechanisms driving the antidepressant effects of physical activity in humans are poorly understood. Building on links between depressive symptoms, reward processing and dopamine, plus evidence from animal studies that physical activity is anti-inflammatory and boosts both dopamine and reward processing, the overarching aim of this trial is to understand the mechanisms underlying the effects of physical activity in depression, focusing on the concept of motivation. |
The key objective is to conduct a randomised controlled trial (RCT) in N=250 depressed participants comparing aerobic exercise to a stretching/relaxation control condition, examining a range of mechanistic factors. The proposed trial will examine the impact of physical activity at multiple, linked potential levels of explanation: (1) immune-metabolic markers; (2) dopamine synthesis capacity; (3) activation in the brain's reward and effort processing circuitry;(4) effort-based decision making incorporating computational analysis; and (5) symptom networks based on fine-grained, daily measurements. conditions: Depression studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The trial will use a single-site parallel group design with depressed participants randomised to eight weeks of either 45 minutes of aerobic exercise of moderate-to-vigorous activity (experimental group: three times per week, N=125) or 45 minutes of non-aerobic stretching/guided relaxation (control group: three times per week, N=125). primaryPurpose: TREATMENT masking: SINGLE maskingDescription: The control arm is stretching and relaxation. Prior research indicates that participants have similar efficacy expectations regarding mild stretching and aerobic exercise, which will help to improve masking. Due to the nature of the interventions, it is not possible for the participants to be masked as to the intervention they are undergoing, but all study information will be agnostic about which intervention we expect to be more effective, and all analysis will be performed by blinded staff. The trial will assess expectations and preferences about the intervention conditions, allowing for sensitivity analyses. whoMasked: PARTICIPANT count: 250 type: ESTIMATED name: Aerobic exercise name: Stretching and relaxation measure: Patient Health Questionnaire-9 score measure: Physical activity measure: Aerobic capacity: CPET measure: Ecological Momentary Assessment measure: Inflammatory response (cytokines) measure: Inflammatory response (genetic markers) measure: Inflammatory response (flow cytometry immunophenotype) measure: Neuroendocrine system measure: Metabolic function measure: Dopamine synthesis capacity measure: Functional magnetic resonance imaging (fMRI) during cognitive tasks measure: Online cognitive tasks measure: Depression symptoms measure: Anxiety (GAD7 score) measure: Anxiety (STAI score) measure: Anhedonia (SHAPS score) measure: Anhedonia (DARS score) measure: Apathy measure: Fatigue measure: Cognitive impairment measure: Self-efficacy measure: Self-esteem measure: Sleep quality sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT hasResults: False |
<|newrecord|> nctId: NCT06387719 id: PREC-BED Study briefTitle: Precursors of Binge Eating Disorder in a Clinical Sample of Adolescents With Obesity acronym: PREC-BED overallStatus: RECRUITING date: 2023-07-21 date: 2025-03 date: 2026-05 date: 2024-04-29 date: 2024-04-29 name: Fundació Sant Joan de Déu class: OTHER name: Instituto de Salud Carlos III briefSummary: BACKGROUND: Binge eating disorder (BED) is the worldwide most-prevalent eating disorder. It is associated with psychiatric comorbidities and obesity, a high impact in life functioning, and high morbidity and mortality. First symptoms appear frequently in youths, who most commonly present incomplete (subthreshold) criteria for BED (precursor forms, PREC-BED). While some subjects will evolve from PREC-BED to BED, there is no gold standard to identify the clinical evolution. Information from prior studies suggest early alterations in reward and inhibitory brain circuits in PREC-BED may predict increased vulnerability or resilience to develop BED. Tools based on MRI brain connectivity analyses (MRI-BC), built on robust and interpretable connectivity whole-brain models, have proven successful in diagnostic classification and predicting certain clinical outcomes. OBJECTIVES: To study MRI-BC diagnostic markers of PREC-BED and to explore prognosis at 1 year of follow-up in a sample of adolescents with obesity (12-17 years old). METHODS: A) Transversal analytical design: 3-group (n=34 per group) comparison of neuroimaging (MRI-BC), neurocognitive and clinical markers in adolescents with obesity and i) BED, ii) PREC-BED, iii) no BED nor PREC-BED (Healthy group, HC). B) Longitudinal analytical design, pilot, exploratory: adolescents with PREC-BED will be evaluated in clinical and neurocognitive variables at 1 year. Baseline brain neuroimaging variables (alone and in combination with clinical and neurocognitive variables) will be analyzed as predictors of clinical prognosis, including conversion to BED. conditions: Binge-Eating Disorder conditions: Obesity conditions: Eating Disorders conditions: BED conditions: Other Specified Feeding or Eating Disorder conditions: Eating Disorder Nos conditions: Emotion Regulation conditions: Food Addiction studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 102 type: ESTIMATED name: Magnetic resonance imaging measure: Neuroimaging assessment measure: Neuroimaging assessment measure: Height measure: Weight measure: Waist perimeter measure: BMI measure: Blood pressure measure: Fasting glucose measure: Triglycerides measure: HDL cholesterol measure: Developmental Tanner stage measure: Adherence to Mediterranean diet measure: Diagnosis of BED, and PREC-BED or exclusion of other DMS-5 diagnosis. measure: Functioning measure: Depression measure: Anxiety measure: Emotion Regulation measure: Eating symptomatology measure: Eating symptomatology measure: Temperamental tendencies for sensitivity to punishment and sensitivity to reward. measure: Food Addiction measure: Food intake measure: General Intelligence measure: Attention ability measure: Visuo-constructional ability and visual memory measure: Executive function: cognitive flexibility, alternating attention, sequencing, visual search, and motor speed. measure: Executive function: working memory ability measure: Executive function: decision-making abilities reward based measure: Executive function: ability to inhibit cognitive interference measure: Executive function: planning and strategic organisation sex: ALL minimumAge: 12 Years maximumAge: 16 Years stdAges: CHILD facility: Hospital Sant Joan de Déu status: RECRUITING city: Esplugues De Llobregat state: Barcelona zip: 08950 country: Spain name: ESTHER VIA VIRGILI role: CONTACT phone: 34 + 673342094 email: [email protected] name: ESTHER VIA VIRGILI role: PRINCIPAL_INVESTIGATOR name: EDUARDO SERRANO role: SUB_INVESTIGATOR name: RAQUEL CECILIA role: SUB_INVESTIGATOR name: SILVIA MARÍN role: SUB_INVESTIGATOR name: MARINA LLOBET role: SUB_INVESTIGATOR name: LAURA MARITZA ASTIASUAINZARRA VILLA role: SUB_INVESTIGATOR name: LILIANA SZEGHALMI role: SUB_INVESTIGATOR name: ANTONIO PÉREZ role: SUB_INVESTIGATOR name: MATTHIEU GILSON role: SUB_INVESTIGATOR name: MANEL VILA-VIDAL role: SUB_INVESTIGATOR name: GUIDO FRANK role: SUB_INVESTIGATOR name: CHRISTIAN STEPHAN OTTO role: SUB_INVESTIGATOR lat: 41.37732 lon: 2.08809 hasResults: False |
<|newrecord|> nctId: NCT06387706 id: GAP briefTitle: The Development of a Gamified Web-based Pain Management Program (GAP) for Community-dwelling Older Adults With Chronic Pain overallStatus: RECRUITING date: 2023-12-01 date: 2024-07-30 date: 2024-11-30 date: 2024-04-29 date: 2024-04-29 name: The Hong Kong Polytechnic University class: OTHER briefSummary: Pain Management in Older Adults: Pain significantly impacts the well-being of older adults, often leading to diminished physical abilities and a reduced quality of life. Despite this, pain management remains suboptimal, with concerns about medication side effects and a tendency to view pain as a natural aspect of aging. Consequently, many seniors are hesitant to use painkillers. As an alternative, non-pharmacological strategies such as educational programs, physical activity, massage, relaxation techniques, and music therapy are gaining traction. |
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