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<|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
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1 Data collection and evaluation tools
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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.
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2. The anxiety was self-scored using the VAS-A (0-10 points), with 0 point as no anxiety and 10 as severe anxiety.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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
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<|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.
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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.
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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
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<|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
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<|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
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<|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.
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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.
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Secondary Objective: Bridge Therapy activation will also result in a lower incidence of rescue pharmacologic treatment of agitation.
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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
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<|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
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<|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
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<|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:
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* Does DBS lower the pain score in these participants.
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* 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.
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Participants will:
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* Undergo baseline screening procedures and have an MRI scan.
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* Have neurosurgery to put the DBS system in
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* Have follow up for 10 months
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* Visit the clinic at least 5 times in the study for check-ups and tests
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* 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.
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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
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<|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.
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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.
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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.
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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
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<|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
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<|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
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<|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
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<|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.
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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
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<|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:
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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
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<|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:
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* Is Sivelestat sodium more effective in the treatment of patients with moderate to severe ARDS compared with placebo?
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* 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
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<|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
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<|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.
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1. Cooking Matters for Adults (CMA) Curriculum Delivery over 6 weeks
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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
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<|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
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<|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.
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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.
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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
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<|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
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<|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
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<|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.
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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.
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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
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<|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
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<|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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Innovative Non-Drug Solutions: To improve participation in non-medication pain relief methods, we suggest incorporating gaming elements into these programs (GAP). Originating in digital media in 2008, gamification has since spread across various industries. It involves adding game-like elements to activities to boost engagement, experience, and motivation.
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Project Goals: The aims of this initiative include creating a web-based Gamified Pain Management Program (GAP), engaging older adults with chronic pain in the development of GAP, and gathering their feedback on the program's effectiveness. conditions: Chronic Pain Syndrome studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: PREVENTION masking: NONE count: 4 type: ESTIMATED name: Gamified web-based pain management Program measure: Pain Relief sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hong Kong Metropolitan University status: RECRUITING city: Hong Kong country: Hong Kong name: Mimi Mun Yee Tse, PhD. role: CONTACT phone: (852)39708764 email: [email protected] name: Mimi Mun Yee Mimi Mun Yee, PhD. role: PRINCIPAL_INVESTIGATOR name: Tyrone Tai On Kwok, PhD. role: SUB_INVESTIGATOR name: Timothy Chung Ming Wu, Master role: SUB_INVESTIGATOR lat: 22.27832 lon: 114.17469 hasResults: False
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<|newrecord|> nctId: NCT06387693 id: 24U-1359 briefTitle: Artificial Intelligence in ANOCA acronym: (AI)NOCA overallStatus: NOT_YET_RECRUITING date: 2024-08 date: 2028-08 date: 2028-12 date: 2024-04-29 date: 2024-04-29 name: UMC Utrecht class: OTHER briefSummary: Angina pectoris is diagnosed in \>180.000 people in the Netherlands each year. Diagnosis in angina pectoris focuses on epicardial coronary stenosis, the identification of which may lead to guideline-directed medical therapy or revascularization. However, no such stenosis is identified in 40-70% of patients. This condition, angina with no obstructed coronary artery (ANOCA), is more prevalent in women and is related to poor quality of life, high medical expenses, and a higher incidence of adverse events.
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The origin of ANOCA can be evaluated during invasive coronary angiography by coronary function testing (CFT) to identify coronary vasomotor disorders. This relates to vasospasm of the coronary artery and microcirculation, or to impaired microvascular vasodilation. For the diagnosis of vasospasm, CFT needs to result in electrocardiographic signs of myocardial ischemia as part of the diagnostic criteria. This is a critical point in the diagnosis of vasospasm, as these signs can be subtle and can vary, and are therefore prone to misinterpretation. Apart from this caveat, the diagnosis approach therefore currently requires an invasive procedure for the diagnosis. This limits the broad application and hampers early identification and treatment of ANOCA.
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During CFT, a coronary guide wire is routinely advanced in the coronary artery which also allows obtaining an intracoronary ECG by attaching a sterile alligator clamp to a standard electrocardiogram lead. This allows continuous recording of intracoronary ECG throughout CFT on the same monitor as the routine ECG. This technique can increase sensitivity for myocardial ischemia during CFT. Further, Holter ECG monitoring allows the identification of ischemic changes in the ECG in the outpatient setting. Evidence is lacking on the patterns of myocardial ischemia that occur during spontaneous angina pectoris symptoms in ANOCA patients, and on the sensitivity of Holter ECG for this purpose. Finally, the interpretation of ischemic patterns on ECG tracings can be cumbersome, especially when changes are subtle or change from beat to beat. The use of deep learning techniques allows to automate the interpretation of ECG traces and may improve the standardized diagnosis in ANOCA. conditions: Angina, Stable studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 250 type: ESTIMATED name: Holter monitoring, intracoronary ECG measure: Prevalence of myocardial ischemia in patients with equivocal coronary function test results measure: Diagnostic accuracy of perprocedural Holter ECG monitoring to diagnose coronary vasomotor disorders measure: Diagnostic ccuracy of outpatient Holter monitoring for coronary vasomotor disorders sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06387680 id: 2022/187 briefTitle: The Peanut Ball Use on Labor overallStatus: COMPLETED date: 2023-01-01 date: 2024-03-01 date: 2024-04-01 date: 2024-04-29 date: 2024-04-29 name: Selcuk University class: OTHER briefSummary: The purpose of this study was to evaluate the effect of using peanut balls during labor on labor memory, labor satisfaction, labor length, and neonatal APGAR scores. conditions: Birth Outcome, Adverse conditions: Birth, First conditions: Labor Long conditions: Apgar; 4-7 at 1 Minute studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: PARTICIPANT count: 140 type: ACTUAL name: The Effect of Peanut Ball Use on Labor Memory, Labor Satisfaction, Delivery Length, and Neonatal APGAR Score: A Randomized Controlled Trial measure: Comparison of sociodemographic of pregnant women. measure: Comparison of obstetric characteristics of pregnant women measure: Comparison of postpartum characteristics of pregnant women measure: Comparison of duration of 1st and 2nd stage of labor by group measure: Comparison of 1st and 5th minute APGAR scores of newborns by group measure: Comparison of the mean scores of the Pregnant Women's Birth Memory and Recall Questionnaire (BirthMARQ) and its subscales by groups measure: Comparison of pregnant women's Birth Satisfaction Scale (BSS) mean scores by groups sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Selcuk University city: Konya zip: 42250 country: Turkey lat: 37.87135 lon: 32.48464 hasResults: False
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<|newrecord|> nctId: NCT06387667 id: FIRTI briefTitle: Characterizing Diversity and Antifungal Resistance in Immunocompromised ICU Patients With Respiratory Tract Infections overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-12-01 date: 2026-06-01 date: 2024-04-29 date: 2024-04-29 name: New Valley University class: OTHER briefSummary: Immunocompromised individuals face a heightened risk of life-threatening fungal infections, which arise from a multitude of environmental and commensal fungi. Surveillance data from ICUs worldwide identifies Candida spp. as the dominant foe, responsible for 80% of such infections, earning it the dubious distinction of being the third most prevalent pathogen. While C. albicans holds the dubious crown as the most common Candida offender, recent years have witnessed a concerning trend toward non-Albicans candida, raising concerns about potential antifungal resistance. conditions: Immunocompromised ICU Patients With Respiratory Tract Infections studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Immunocompromised ICU Patients with Respiratory tract infections primaryPurpose: DIAGNOSTIC masking: NONE count: 250 type: ESTIMATED name: Complete blood count name: C-reactive protein, urea, creatinine, Random blood glucose (RBG), aspartate aminotransferase (AST), alanine aminotransferase (ALT) name: CT chest name: Microscopic examination name: culture and sensitivity measure: Number of fungal species causing pneumonia in immunocompromised ICU patients measure: Determine the antifungal susceptibility profiles of the identified fungal isolates. measure: Number of associated specific patient factors with the type or antifungal resistance of fungal infections sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06387654 id: RC31/23/0361 briefTitle: Clinico-biological Collection of Autoimmune, Dysimmune or Auto-inflammatory Dermatological Diseases acronym: TekAPo overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2029-04 date: 2034-04 date: 2024-04-29 date: 2024-04-29 name: University Hospital, Toulouse class: OTHER briefSummary: The aim of this project is to start a biological and clinical collection of patients presenting autoimmune, dysimmune or auto-inflammatory dermatological diseases. This collection will provide appropriate biological samples to identify new biomarkers and to be accessible to the medical, scientific and industrial communities for the identification of new therapeutic strategies. conditions: Autoimmune Bullous Dermatosis conditions: Systemic Autoimmune Diseases With Dermatological Presentation conditions: Dysimmune Dermatological Diseases conditions: Auto-inflammatory Dermatological Diseases studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 800 type: ESTIMATED name: Blood sampling name: Remainders of samples taken as part of the treatment measure: Building a collection of biological samples and clinical-biological data from patients with autoimmune, dysimmune or auto-inflammatory dermatological disease measure: Identification of new autoantibodies measure: Identification of biomarkers regarding the severity (such as cytokines, survival factors) in order to help the therapeutic decisions measure: Exploration of the pathophysiological mechanisms of rare autoimmune dermatological pathologies measure: Comparison of blood cells populations determinants with flow cytometry, before and after cell therapy and in patients responder or not responder to cell therapy sex: ALL minimumAge: 6 Years maximumAge: 99 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Purpan University Hospital city: Toulouse zip: 31059 country: France name: Chloé BOST, MD, PhD role: CONTACT phone: 5 61 77 61 44 phoneExt: 0033 email: [email protected] lat: 43.60426 lon: 1.44367 hasResults: False
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<|newrecord|> nctId: NCT06387641 id: 2024004 briefTitle: Effects of Life Review Intervention on Meaning in Life Among Older Adults With Disabilities overallStatus: ENROLLING_BY_INVITATION date: 2024-03-25 date: 2025-01-01 date: 2025-01-01 date: 2024-04-29 date: 2024-04-29 name: Bao Huimin class: OTHER briefSummary: The goal of this interventional study is to learn if life review works to improve the sense of meaning in life in older adults with disabilities who live at home. The main questions it aims to answer are:
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Does life review enhance the sense of meaning in life of participants? Dose life reviews enhance the life satisfaction of participants. Dose life reviews enhance the quality of life of participants?
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Researchers will compare the life review program to routine community health services to see if the life review intervention program is effective in enhancing the sense of meaning in life of older adults with disabilities who live at home.
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Participants will:
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Take face-to-face life review interview or routine community health service every week for 6 weeks.
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Take the the questionnaire survey before and after the six-week life review intervention. conditions: Disabilities, Psychological studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 68 type: ESTIMATED name: Life review name: Routine community health services measure: Change from Baseline in Meaning in life on the Meaning in Life Questionnaire (MLQ) at Week6 measure: Change from Baseline in Life satisfaction on the Life Satisfaction In-dex A (LSIA) at Week6 measure: Change from Baseline in Quality of life on the 12-Item Short Form Survey (SF-12) at Week6 sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Xixi Street Community Health Service Center city: Hanzhou state: Zhejiang zip: 310012 country: China lat: 26.4965 lon: 99.437 facility: Gongchenqiao Street Community Health Service Centre city: Hanzhou state: Zhejiang zip: 310015 country: China lat: 26.4965 lon: 99.437 facility: Baiyang Street Wenchao Community Health Centre city: Hanzhou state: Zhejiang zip: 310018 country: China lat: 26.4965 lon: 99.437 facility: School of Nursing, Hangzhou Normal University city: Hanzhou state: Zhejiang zip: 311121 country: China lat: 26.4965 lon: 99.437 hasResults: False
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<|newrecord|> nctId: NCT06387628 id: LM108-IIT-202 briefTitle: LM-108 in Combination With PD-1 Based Treatment for Patients With Recurrent or Metastatic Triple - Negative Breast Cancer overallStatus: RECRUITING date: 2024-06-01 date: 2026-04-01 date: 2027-04-01 date: 2024-04-29 date: 2024-04-29 name: Fudan University class: OTHER briefSummary: To evaluate the efficacy and safety of LM108 plus toripalimab plusnab-paclitaxel or eribulin as first-line or post-line treatment in patients with metastatic triple-negative breast cancer. conditions: TNBC - Triple-Negative Breast Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 74 type: ESTIMATED name: LM-108 name: Toripalimab name: Eribulin name: Nab paclitaxel measure: ORR measure: DoR measure: DCR measure: PFS measure: OS measure: Adverse events sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fudan University Shanghai Cancer Center status: RECRUITING city: Shanghai state: Shanghai zip: 200032 country: China name: Biyun Wang role: CONTACT phone: 18017312387 email: [email protected] lat: 31.22222 lon: 121.45806 hasResults: False
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<|newrecord|> nctId: NCT06387615 id: H22086 id: 1R21HD108576-01A1 type: NIH link: https://reporter.nih.gov/quickSearch/1R21HD108576-01A1 briefTitle: Impact of Non-invasive Brain Stimulation on Learning Novel Spoken Words overallStatus: RECRUITING date: 2024-01-01 date: 2024-10-31 date: 2025-12-31 date: 2024-04-29 date: 2024-04-29 name: Georgia State University class: OTHER name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) briefSummary: The purpose of the proposed study is to use transcranial magnetic stimulation (TMS) to evaluate a neurobiological model of spoken word learning in older youth. Specifically, it is hypothesized that: (1) inhibition of the left dorsal stream will impact subsequent learning, processing, and retention of phonologically similar pseudowords; (2) the impact of dorsal stream inhibition on word learning will be associated with baseline levels of variability in neural activity, indicative of underlying differences in cortical excitability. conditions: Dyslexia conditions: Dyslexia, Developmental conditions: Learning; Developmental Disorder, Reading studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: SINGLE whoMasked: PARTICIPANT count: 40 type: ESTIMATED name: Active cTBS name: Sham measure: Novel Word Learning Task measure: Pseudoword Discrimination Task measure: MRI Scan sex: ALL minimumAge: 16 Years maximumAge: 24 Years stdAges: CHILD stdAges: ADULT facility: Georgia State University/Georgia Tech Center for Advanced Brain Imaging (CABI) status: RECRUITING city: Atlanta state: Georgia zip: 30318 country: United States name: C.Nikki Arrington, PhD role: CONTACT phone: 404-385-8621 lat: 33.749 lon: -84.38798 hasResults: False
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<|newrecord|> nctId: NCT06387602 id: FUI/CTR/2024/6 briefTitle: Comparison Between Effects of Active Release Technique and Post Isometric Relaxation on Adductor Strain in Mixed Martial Arts Fighters overallStatus: RECRUITING date: 2023-07-15 date: 2023-11-20 date: 2024-11-20 date: 2024-04-29 date: 2024-04-29 name: Foundation University Islamabad class: OTHER briefSummary: This study is a randomized controlled trial and the purpose of this study is to compare the effects between active release technique and post-isometric relaxation on adductor strain in mixed martial arts fighters. conditions: Adductor Strain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized Controlled Trial primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: Cryotherapy name: Strengthening of adductors name: Active release technique name: Post-Isometric Relaxation measure: Pain Intensity measure: Range of motion measure: Functionality measure: Flexibility sex: ALL minimumAge: 20 Years maximumAge: 35 Years stdAges: ADULT facility: Foundation University College of Physical Therapy status: RECRUITING city: Rawalpindi state: Punjab zip: 46000 country: Pakistan name: Furqan Yaqoob, MS-OMPT,PHD* role: CONTACT phone: 03465333101 email: [email protected] lat: 33.6007 lon: 73.0679 hasResults: False
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<|newrecord|> nctId: NCT06387589 id: FUI/CTR/2024/5 briefTitle: Effects of Static Stretching Versus Post Facilitation Stretch of Iliopsoas in Non-Specific Low Back Pain overallStatus: RECRUITING date: 2023-07-15 date: 2023-11-20 date: 2024-06-20 date: 2024-04-29 date: 2024-04-29 name: Foundation University Islamabad class: OTHER briefSummary: This study is a randomized controlled trial and the purpose of this study is to determine the effects of Static Stretching Versus Post Facilitation Stretch of Iliopsoas combined with core stability exercises in Non-Specific Low Back Pain" conditions: Low Back Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized Controlled Trial primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: Core stability exercises name: Static Stretching of Iliopsoas name: Post Facilitation Stretch of Iliopsoas measure: Pain intensity measure: Level of disability measure: Lumbar Range of motion measure: Hip Range of motion sex: ALL minimumAge: 30 Years maximumAge: 50 Years stdAges: ADULT facility: Foundation University College of Physical Therapy status: RECRUITING city: Rawalpindi state: Punjab zip: 46000 country: Pakistan name: Sana Khalid, MSNMPT,PHD role: CONTACT phone: 03315050460 email: [email protected] lat: 33.6007 lon: 73.0679 hasResults: False
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<|newrecord|> nctId: NCT06387576 id: Post-discharge Appointments briefTitle: Post-Discharge Follow-up Appointment Scheduling overallStatus: RECRUITING date: 2024-04-08 date: 2024-05 date: 2024-06 date: 2024-04-29 date: 2024-04-29 name: University of California, Los Angeles class: OTHER briefSummary: This is a prospective clinical trial evaluating whether a behaviorally informed intervention (pre-discharge iPad video scheduling) increases post-discharge primary care physician (PCP) appointment completion compared to the status-quo scheduling process (post-discharge via phone), with the ultimate goal of improving patient health outcomes. conditions: Appointments and Schedules studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Parallel-arm control trial primaryPurpose: HEALTH_SERVICES_RESEARCH masking: SINGLE whoMasked: PARTICIPANT count: 300 type: ESTIMATED name: Behaviorally informed pre-discharge iPad video scheduling measure: Post-discharge follow-up PCP appointment completion rate within 7 days measure: Post-discharge follow-up PCP appointment completion rate within 14 days measure: Post-discharge follow-up PCP appointment scheduling rate within 7 days sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UCLA Santa Monica Medical Center status: RECRUITING city: Santa Monica state: California zip: 90404 country: United States name: Rich Leuchter, MD role: CONTACT phone: 310-825-9111 email: [email protected] lat: 34.01945 lon: -118.49119 hasResults: False
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<|newrecord|> nctId: NCT06387563 id: FUI/CTR/2024/4 briefTitle: Effects of Abdominal Muscle Activation Training, Using Pressure Biofeedback in Comparison With Surface Electromyography overallStatus: RECRUITING date: 2023-11-06 date: 2024-05-01 date: 2024-05-30 date: 2024-04-29 date: 2024-04-29 name: Foundation University Islamabad class: OTHER briefSummary: This study is a randomized control trial and the purpose of this study to determine the effects of abdominal muscle activation training on non-specific low back pain; using pressure biofeedback in comparison with surface electromyography biofeedback: a randomized control trial. conditions: Low Back Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized control trial primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: Abdominal activation using pressure biofeedback name: Abdominal activation using SEMG biofeedback measure: Pain Intensity measure: Level of Disability sex: ALL minimumAge: 18 Years maximumAge: 44 Years stdAges: ADULT facility: Foundation University College of Physical Therapy status: RECRUITING city: Rawalpindi state: Punjab zip: 46000 country: Pakistan name: Anam Rehman, MS-OMPT role: CONTACT phone: 03355082299 email: [email protected] lat: 33.6007 lon: 73.0679 hasResults: False
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<|newrecord|> nctId: NCT06387550 id: FUI/CTR/2024/3 briefTitle: Effects of Eccentric Training on Glycemic Control and Quality of Life in Patients With Type II Diabetes Mellitus overallStatus: RECRUITING date: 2024-03-20 date: 2024-07-01 date: 2024-07-15 date: 2024-04-29 date: 2024-04-29 name: Foundation University Islamabad class: OTHER briefSummary: Diabetes is defined by the level of hyperglycemia its a metabolic chronic disorder that furthur lead to life threatning medical conditions however, the prevalence of diabetes is rapidly increasing day by day in both developed and developing countries making it global pandemic and type II is more prevalent. Life dependency is increased due to long term effects of diabetes in specifically older individuals. Physical activity and exercise improves glucose tolerance and also reduces other life threatening diabetic complications, improving the quality of life in diabetic population. conditions: Type II Diabetes Mellitus studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: This is a pre-post quasi experimental study having one group analysis.Participants will be selected through inclusion and exclusion criteria then pre assessment would be done that include HBA1C and EQ5DL QOL tool, followed by intervention and post assessment. primaryPurpose: TREATMENT masking: NONE count: 24 type: ESTIMATED name: Eccentric Training measure: Glycemic control measure: Patient's quality of life sex: ALL minimumAge: 40 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Foundation University College of Physical Therapy status: RECRUITING city: Rawalpindi state: Punjab zip: 46000 country: Pakistan name: Zara Khalid, PhD* role: CONTACT phone: +923335415822 email: [email protected] lat: 33.6007 lon: 73.0679 hasResults: False
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<|newrecord|> nctId: NCT06387537 id: FUI/CTR/2024/2 briefTitle: Effects of Scapular Mobilization on Shoulder Proprioception and Pain in Patients With Adhesive Capsulitis overallStatus: RECRUITING date: 2024-03-01 date: 2024-07-01 date: 2024-07-15 date: 2024-04-29 date: 2024-04-29 name: Foundation University Islamabad class: OTHER briefSummary: Adhesive capsulitis is a common musculoskeletal condition. Painful gradual loss of both active and passive gleno-humeral motion resulting from progressive fibrosis and ultimate contracture of the gleno-humeral joint capsule.Scapular position and movement perception both effected by shoulder adhesive capsulitis, change in the scapular kinematics in the form of an increase in scapular lateral rotation, and reduced joint sense for shoulder movements in adhesive capsulitis. Physiotherapists have a wide range of options in managing Adhesive capsulitis including Electrotherapeutic modalities, kaltenborn mobilization, Maitland's mobilization,Mulligan's mobilization and Manipulation. So far studies have shown the efficacy of different treatments in combination or in isolation.Few studies on proprioception in rotator cuff tear, sub acromial impingment syndrome, but no obseved effects of scapular mobilization on shoulder proprioception in patients with adhesive capsulitis.Physical therapist focus on lowering pain and ROM limitations in the shoulder,but often neglect to evaluate proprioception/joint position sense as well as the roleof scapula in adhesive capsulitis during treatment.If found effective,this study can help in probviding treatment protocols for improving proprioception in patients with adhesive capsulits. conditions: Adhesive Capsulitis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is a randomized controlled trial having two groups. One group will receive conventional physical therapy and the second will receive conventional physical therapy along with scapular mobilization. Both groups will be recruited concurrently. primaryPurpose: PREVENTION masking: NONE count: 30 type: ESTIMATED name: Conventional physical therapy name: Scapular mobilization. measure: Shoulder Proprioception measure: Pain Intensity measure: Shoulder Range of motion measure: Shoulder Disability sex: ALL minimumAge: 40 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Foundation University College of Physical Therapy status: RECRUITING city: Rawalpindi state: Punjab zip: 460000 country: Pakistan name: Zara Khalid, DPT, MS-CPPT,PHD* role: CONTACT phone: +923335415822 email: [email protected] lat: 33.6007 lon: 73.0679 hasResults: False
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<|newrecord|> nctId: NCT06387524 id: FUI/CTR/2024/1 briefTitle: Effects of Eccentric Exercises on Gait Parameters in Patellofemoral Pain Syndrome: A Quasi-Experimental Study overallStatus: RECRUITING date: 2023-07-15 date: 2024-11-20 date: 2024-11-20 date: 2024-04-29 date: 2024-04-29 name: Foundation University Islamabad class: OTHER briefSummary: This study is a quasi experimental and the purpose of this study is to determine the effects of eccentric exercises on gait parameters in patellofemoral pain syndrome: a quasi - experimental study conditions: Patellofemoral Pain Syndrome studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Quasi experimental study primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: McConnell Taping name: ECCENTRIC EXERCISES: measure: Dynamic knee valgus angle measure: Hip Range of Motion measure: Knee Range of Motion measure: Pain intensity measure: Gait Speed measure: Cadence measure: Stride length measure: Step length measure: Cycle length sex: ALL minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT facility: Foundation University College of Physical Therapy status: RECRUITING city: Rawalpindi state: Punjab zip: 46000 country: Pakistan name: Qurat ul Ain Saeed, MS-OMPT,PHD* role: CONTACT phone: 03315562889 email: [email protected] lat: 33.6007 lon: 73.0679 hasResults: False
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<|newrecord|> nctId: NCT06387511 id: NutriVax-Measles briefTitle: Increasing Measles Vaccination Coverage Through Supplementation With an SQ-LNS Incentive in Children Aged 6-23 Months overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-06-15 date: 2025-06-15 date: 2024-04-29 date: 2024-04-29 name: Alliance for International Medical Action class: OTHER name: Institut National de la Santé Et de la Recherche Médicale, France name: Programme PAC-CI, Site ANRS-MIE de Côte d'Ivoire name: Yobe State Ministry of Health, Nigeria name: Eleanor Crook Foundation name: Gavi, The Vaccine Alliance briefSummary: Provision of SQ-LNS also holds promise in incentivizing vaccination as well as other health services.
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We will estimate 1) the effectiveness of a SQ-LNS mass supplementation program added to routine immunization program compared to routine immunization program alone in terms of measles vaccine coverage, after 12 months of program implementation, 1) in children aged 12-23 months in the endline cross-sectional household survey, 2) in children aged 6-12 months at inclusion in a longitudinal 12 months follow-up survey.
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Secondary objectives are to assess the barriers and facilitators from the perspectives of parents/legal guardian of children, health care providers and community health workers and to assess the cost-efficiency of the
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This study will implrmented in 20 wards covering the Karasuwa and Nguru Local Government Areas (LGAs) in Yobe state, Northeast Nigeria.
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This is a pragmatic parallel cluster randomized trial (PCT) with baseline measure with different populations and data collection modes: 1) baseline and endline cross-sectional household surveys of children aged 12-23 months, 2) a longitudinal follow-up survey (LS) of children aged 6-12 months at inclusion, 3) a qualitative feasibility and acceptability survey of parents of children aged 6-23 months, of health providers, of community health workers and community representatives and 4) a cost survey of parents/legal guardian of children from the longitudinal follow-up cohort, and 5) a health facility cost survey of a randomized sub-sample of health facilities.
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Clusters will be randomly allocated at a ratio of 1:1 either to the standard arm or to the NutriVax arm:
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* The standard Expanded Program on Immunization (EPI) in children aged 6-23 months delivered according to the Ministry of Health's routine plans in the community and at health centres and health posts, named the standard EPI arm;
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* The NutriVax program combining the EPI in children aged 6-23 months according to the Ministry of Health's routine plans in the community and at health centres (i.e. PHCCs) and health posts associated with SQ-LNS mass supplementation integrated into pre-existing services delivered at health centres (i.e. PHCCs) for children 6-23 months of age, named the NutriVax arm. conditions: Immunization Coverage Improvment studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A two arms opened pragmatic parallel cluster-randomized controlled trial with baseline measure primaryPurpose: PREVENTION masking: NONE maskingDescription: No possible to mask intervention due to the specifity of the intervention tested count: 3720 type: ESTIMATED name: Small-quantity lipid-based nutrition supplements (SQ-LNS) NutriVax measure: Measles vaccine coverage in children aged 12-23 months measure: Measles vaccine coverage in children 6-12 months at inclusion measure: Measles vaccine coverage: at least one dose measure: Measles vaccine coverage : two doses measure: Timeliness of measles 1 vaccination measure: Other infant vaccines coverage measure: Zero-dose measure: Fully immunization measure: Acceptability measure: Cost-efficiency sex: ALL minimumAge: 6 Months maximumAge: 23 Months stdAges: CHILD hasResults: False
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<|newrecord|> nctId: NCT06387498 id: 20-2286 briefTitle: Testicular Tissue Cryopreservation (TTC) acronym: TTC overallStatus: RECRUITING date: 2020-09-28 date: 2027-12-30 date: 2027-12-30 date: 2024-04-29 date: 2024-04-29 name: University of Colorado, Denver class: OTHER briefSummary: The "Testicular Tissue Cryopreservation" study is open to a subset of patients facing disease or treatment regimens that could lead to infertility (gonadotoxic therapies). For some of these patients, experimental testicular tissue cryopreservation is the only fertility preservation option available. The overall objective of this study is to determine the feasibility and acceptability of testicular tissue cryopreservation in male patients of all ages who have a condition or will undergo a treatment that can cause infertility. conditions: Fertility Issues studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: PREVENTION masking: NONE count: 60 type: ESTIMATED name: Testicular tissue biopsy and cryopreservation measure: Feasibility, as Assessed via the Percentage of Eligible Patients who do a Procedure measure: Feasibility, as Assessed via Percentage of Patients who Attempted a Procedure who were able to Cryopreserve measure: Safety, as Assessed via the Number of Participants with At Least One Pre-specified Adverse Event measure: Safety, as Assessed via the Number of Participants with At Least One Pre-specified Adverse Event measure: Safety, as Assessed via the Number of Participants with At Least One Pre-specified measure: Safety, as Assessed via the Number of Participants with At Least One Pre-specified measure: Acceptability, as Assessed via Annual Survey Regret Score sex: MALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: University of Colorado status: RECRUITING city: Aurora state: Colorado zip: 80045 country: United States name: Jocelyn Phipers, RN role: CONTACT phone: 303-724-7807 email: [email protected] name: Leslie Appiah, MD role: CONTACT email: [email protected] name: Leslie Appiah, MD role: PRINCIPAL_INVESTIGATOR lat: 39.72943 lon: -104.83192 hasResults: False
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<|newrecord|> nctId: NCT06387485 id: SR-001 briefTitle: A Study to Evaluate the Utilization of 3D Printed Models in Pre-Operative Planning overallStatus: RECRUITING date: 2024-03-01 date: 2024-12-31 date: 2025-04-01 date: 2024-04-29 date: 2024-04-29 name: Ricoh USA, Inc. class: INDUSTRY briefSummary: This prospective, multi-center, randomized controlled study aims to assess the efficacy of utilizing 3D printed models in preoperative planning for the excision of tumors involving bony structures within the body. The study is expected to last approximately 12 months and involve up to 150 subjects across 3 sites. Subjects will be randomized in a 1:1 ratio into either the experimental arm, utilizing 3D printed models and imaging, or the active comparator arm, using only imaging.
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Primary endpoint: Operative time of surgical procedure.
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Secondary endpoints: Reduction of blood loss, proportion of postoperative adverse events, and negative tumor margins.
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Exploratory endpoints: Surgical planning ease, changes in surgical plan, and surgeon satisfaction. conditions: Sarcoma, Ewing conditions: Chondrosarcoma conditions: Osteosarcoma conditions: Fibrous Histiocytoma conditions: Fibrosarcoma studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 150 type: ESTIMATED name: 3D Printed Anatomic Model name: CT/MRI measure: Operative time measure: Blood loss measure: Adverse Events measure: Tumor margin status sex: ALL minimumAge: 22 Years stdAges: ADULT stdAges: OLDER_ADULT facility: William Beaumont University Hospital status: RECRUITING city: Royal Oak state: Michigan zip: 48073 country: United States name: Pamela Sloan, RN, CCRP role: CONTACT phone: 248-551-6059 email: [email protected] lat: 42.48948 lon: -83.14465 facility: The Ohio State University Wexner Medical Center status: RECRUITING city: Columbus state: Ohio zip: 43212 country: United States name: Rachel Herster, BS role: CONTACT phone: 248-514-4490 email: [email protected] lat: 39.96118 lon: -82.99879 hasResults: False
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<|newrecord|> nctId: NCT06387472 id: 23-007636 briefTitle: DermAI to Evaluate Human Factor of Testing overallStatus: RECRUITING date: 2024-04-29 date: 2024-08-01 date: 2024-12-31 date: 2024-04-29 date: 2024-04-29 name: Mayo Clinic class: OTHER briefSummary: The purpose of this research is to improve how well remote patch allergy testing works and make sure they are easy and practical for people to use from home. conditions: Contact Dermatitis studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SCREENING masking: NONE count: 150 type: ESTIMATED name: AI algorithm to evaluate photographs of skin test patch regions name: Allergen Patch measure: Classification of test site region reaction measure: Classification of test site region using a 5-point scale measure: False Positive Rate measure: False Negative Rate measure: Early termination of testing measure: Participants that removed patches early measure: Adverse events related to allergen exposure sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mayo Clinic in Florida status: RECRUITING city: Jacksonville state: Florida zip: 32224 country: United States name: Laura Pacheco-Spann role: CONTACT phone: 904-953-0408 email: [email protected] name: Matthew Hall, MD role: PRINCIPAL_INVESTIGATOR lat: 30.33218 lon: -81.65565 hasResults: False
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