text
stringlengths 0
197k
|
|---|
<|newrecord|> nctId: NCT06359496 id: CT2024-ZJU-OBS8 briefTitle: Split or Whole Liver Transplantation? A Multicenter Retrospective Cohort Study of Patients With Benign and Malignant Liver Disease overallStatus: COMPLETED date: 2024-02-23 date: 2024-04-02 date: 2024-04-02 date: 2024-04-11 date: 2024-04-11 name: Zhejiang University class: OTHER briefSummary: The primary objective of this study was to assess the safety and feasibility of split liver transplantation(SLT) for adult hepatocellular carcinoma (HCC) patients, while comparing the prognostic disparities between adult SLT and WLT also .
|
Liver transplantation (LT) is an effective treatment for end-stage liver disease. As a traditional marginal donor liver, the application of SLT in pediatric patients is successful.However, its application in adult liver transplantation, especially in HCC patients, remains controversial.
|
This retrospective study analyze outcomes among adults who underwent SLT and whole liver transplantation (WLT) at two centers from January 2018 to August 2022. A 1:1 propensity score matching (PSM) analysis was performed based on important donor and recipient variables. Baseline characteristics and postoperative outcomes of the above recipients were analyzed and compared. Statistical significance was determined using a two-sided p-value threshold of less than 0.05. conditions: Zhejiang University studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 1 type: ACTUAL name: No intervention factor measure: Postoperative complications were evaluated by postoperative imaging reports and serological indicators measure: The survival rate of each group was evaluated by follow-up survey and K-M curve sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Xiao Xu city: Hangzhou country: China lat: 30.29365 lon: 120.16142 hasResults: False
|
<|newrecord|> nctId: NCT06359483 id: 108/2021 briefTitle: The Impact of Meal Frequency on Bone Remodeling in Healthy Adults overallStatus: COMPLETED date: 2021-06-19 date: 2021-07-04 date: 2021-07-04 date: 2024-04-11 date: 2024-04-11 name: University of Jordan class: OTHER name: United Arab Emirates University briefSummary: The study aimed to investigate the effect of meal frequency on bone remodeling using the marker Procollagen Type 1 N-terminal propeptide (P1NP). Thirty healthy adult males from Jordan participated in a randomized controlled intervention trial. They were randomly assigned to three or eight daily meals for three consecutive days over two phases. Blood samples were obtained at the beginning and end of each phase, and P1NP levels were analyzed. The results showed a substantial drop in P1NP levels compared to the baseline, indicating that meal frequency influences bone development. There were no significant changes between the groups eating three and eight meals per day. The study emphasizes the importance of dietary patterns in bone health and advises additional research to understand the relationship between meal frequency and bone metabolism. conditions: Healthy Adults studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: BASIC_SCIENCE masking: NONE count: 30 type: ACTUAL name: Meal Frequency Manipulation measure: The title of the primary outcome is "Procollagen Type 1 N-terminal propeptide (P1NP) Levels." sex: ALL minimumAge: 19 Years maximumAge: 30 Years stdAges: ADULT facility: University of Jordan city: Amman country: Jordan lat: 31.95522 lon: 35.94503 hasResults: False
|
<|newrecord|> nctId: NCT06359470 id: CaiUni briefTitle: the Modified Reversed Contralateral Axial Rotation Position overallStatus: COMPLETED date: 2022-11-05 date: 2023-10-01 date: 2024-01-14 date: 2024-04-11 date: 2024-04-11 name: Noha Khaled Shoukry class: OTHER briefSummary: This study aimed to investigate the effect of specific three-dimensional (3D) positions of the trunk on patients with lumbar discogenic pain with radiculopathy aiming to find a position that directly decompresses the impinged root as well as the effect of this position on the CSA of the L3-L4, L4-L5 and L5-S1 intervertebral foramen (IVF) using 3D-CT scan imaging of the real spine conditions: Disc Prolapse With Radiculopathy studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SEQUENTIAL interventionModelDescription: This study was conducted on ninety male patients (30 in each group), ages ranged from 20 - 40 years old, and were diagnosed with unilateral lumbar disc prolapse (group1: L3-L4), (group 2: L4- L5) and (group 3: L5-S1) for at least three months in a radiology center specialized in the spine (Egyscan center). Each group was imaged three times (from the supine position, then from the oblique position after 10 minutes, and finally from the oblique position again after 48 hours). The oblique image was taken during a specific trunk position the modified reversed contralateral rotation (side-lying with side bending to the non-affected side and rotation to non affected side).The CSA of LIVF and SLR test was assessed at the three times of testing primaryPurpose: TREATMENT masking: NONE count: 90 type: ACTUAL name: Positioning technique measure: Straight leg raising test measure: Foraminal cross sectional area sex: MALE minimumAge: 20 Years maximumAge: 40 Years stdAges: ADULT facility: Faculty of Physical Therapy city: Giza zip: 12556 country: Egypt lat: 30.00808 lon: 31.21093 hasResults: False
|
<|newrecord|> nctId: NCT06359457 id: P.T.REC/012/005016 briefTitle: Correlation Between Serum Progesterone Level And Primary Dysmenorrhea overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2024-06 date: 2024-07 date: 2024-04-11 date: 2024-04-11 name: Cairo University class: OTHER briefSummary: This study will be conducted to determine Correlation between the levels of serum progesterone and Menstrual Symptoms In Young Females conditions: Primary Dysmenorrhea studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: CROSS_SECTIONAL count: 100 type: ESTIMATED measure: Serum progesterone level measure: Pain intensity measure: Physical and psychological symptoms sex: FEMALE minimumAge: 17 Years maximumAge: 24 Years stdAges: CHILD stdAges: ADULT hasResults: False
|
<|newrecord|> nctId: NCT06359444 id: ONZ-2023-0453 briefTitle: Effect of High Intensity Exercise Rehabilitation on Liver Function and Insulin Sensitivity in Patients With MASLD acronym: CENSORIAL overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2026-03-15 date: 2026-03-15 date: 2024-04-11 date: 2024-04-11 name: University Ghent class: OTHER name: University Hospital, Ghent briefSummary: Metabolic dysfunction-associated steatotic liver disease (MASLD) is the most common liver disease worldwide, and is associated with obesity and the metabolic syndrome. Physical activity and lifestyle interventions are among the most recommended treatments for individuals with MASLD.
|
In this RCT, we will evaluate the effect of combined exercise training "strength and aerobic training" versus "strength and high intensity training (HIIT)". The main outcome parameter is the severity of liver steatosis. Patients will be recruited at the fatty liver clinic of the UZ Gent. conditions: Exercise Therapy conditions: Metabolic Dysfunction-associated Steatotic Liver Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Patients will be randomized in two groups: (a) combined aerobic and strength and (b) combined high intensity and strength. primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: The training will be given by the care provider, but in exercise therapy it is not possible to mask. The assessor will assess the patients without knowing in which group they will be randomized. Randomization will be done by an external person who is only involved for randomization. The investigator, who will be analysing data afterwords, will only see 1 or 2 as group number, but will not know which number is corresponding to which group. whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 92 type: ESTIMATED name: Combined aerobic + strength training name: Combined strength + HIIT training measure: Liver steatosis by CAP measure: Liver steatosis on ultrasound measure: Insulin sensitivity measure: Liver transaminases measure: Maximal exercise test measure: Strength measure: Cardiovascular function measure: Weight measure: Heigth measure: BMI measure: waist measure: BIA measure: Interleukine measure: TNF-alfa measure: Hepatokines measure: Myokines measure: Adipokines measure: SF-36 sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT typeAbbrev: SAP hasProtocol: False hasSap: True hasIcf: False label: Statistical Analysis Plan date: 2024-01-29 uploadDate: 2024-03-23T04:06 filename: SAP_000.pdf size: 133707 hasResults: False
|
<|newrecord|> nctId: NCT06359431 id: 1604/CE/CNERSH/SP briefTitle: A Novel Smart Speculum Versus a Standard Speculum for Easy Visualisation of the Cervix and Performing Remote Cervical Cancer Screening overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-06-30 date: 2024-07-30 date: 2024-04-11 date: 2024-04-11 name: GICMED class: OTHER briefSummary: Objective: The main objective of this study is to verify the level of comfort for patients and the degree of cervical visibility for health providers using a novel smart speculum compared to the standard speculum. In addition, establish the feasibility of using this novel smart speculum device with telemedicine for cervical cancer screening in a low-resource setting using VIA compared to the standard of care.
|
Study sites: The study will be carried out in six health facilities in the centre region of Cameroon.
|
Study Period: The study is expected to take 11 months; 4 months for protocol development and approval, 4 months for the training and implementation phase with data collection, 3 months for data analysis, reporting writing and dissemination.
|
Study design: The study will be a multicentre, randomised control single blind trial. Patient participation will be a single study visit. Eligible subjects, consenting to participate will act as their own controls, and will receive speculum examination and cervical cancer screening with both the novel speculum and a traditional speculum. The order of usage of the specula will be randomised, and the women will be blinded on knowing which speculum is being used at a particular time. Level of patient comfort will be evaluated using a visual analogue scale, percentage visualisation of the cervix will be determined following insertion of each of the specula, and results of cervical cancer screening following VIA screening method will be compared between the standard of care procedure to that using the novel smart speculum associated to telemedicine.
|
Patient population: All women between the ages of 21 years and 49 years who come in for consultation.
|
Enrolment size: 81 women will be enrolled in the study. Study procedure: A speculum examination will be done on the day of consultation. Level of patient comfort determined using a visual analogue scale and proportion of the cervix visualised would be recorded into questionnaires. Cervical cancer screening through VIA will be performed with results confirmed on site by the clinician using the standard speculum, while two other clinicians for each case will do a remote diagnosis after reviewing images captured through the novel speculum device and forwarded to them through telemedicine. The remote clinicians will be blinded on the diagnosis proposed by the clinician on site.
|
Primary endpoints: The proportion of clinicians with easy visualisation of the cervix with the 2 specula, level of patient comfort with the novel smart speculum compared to the Standard of care speculum (traditional speculum), reliability of the speculum in carrying out cervical cancer screening using telemedicine.
|
Ethical considerations: The protocol will be submitted for the approval of the National Human Health Research Committee. Written informed consent will be sought for all participants before enrolment into the study. conditions: Cervical Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: SCREENING masking: SINGLE whoMasked: PARTICIPANT count: 81 type: ESTIMATED name: Novel Smart Speculum name: Standard speculum measure: Visualization measure: Reliability in cervical cancer screening using a questionnaire sex: FEMALE minimumAge: 21 Years maximumAge: 49 Years stdAges: ADULT hasResults: False
|
<|newrecord|> nctId: NCT06359418 id: 2024-007-KY briefTitle: Acupuncture for Obesity With Prediabetes overallStatus: NOT_YET_RECRUITING date: 2024-04-10 date: 2026-12-10 date: 2027-03-30 date: 2024-04-11 date: 2024-04-11 name: Guang'anmen Hospital of China Academy of Chinese Medical Sciences class: OTHER name: Hubei Hospital of Traditional Chinese Medicine name: The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine name: Dongfang Hospital Beijing University of Chinese Medicine name: Guangdong Provincial Hospital of Traditional Chinese Medicine name: Heilongjiang Academy of traditional Chinese Medicine briefSummary: The clinical trial aims to evaluate the efficacy and safety of acupuncture on weight loss and changes of glucose and lipid metabolism in obese adults with pre-diabetes. conditions: Obesity conditions: Pre-diabetes studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 260 type: ESTIMATED name: Acupuncture name: Sham acupuncture measure: The percentage change in body weight from baseline to week 12 measure: The percentage change in body weight compared to the baseline measure: Achievement of a reduction in body weight of 5% or more compared to the baseline measure: Achievement of a reduction in body weight of 7% or more compared to the baseline measure: The change in 1hPG from baseline and percentage of patients who returned to normal measure: The change in 2hPG from baseline and percentage of patients who returned to normal measure: The change in FPG from baseline and percentage of patients who returned to normal measure: The change in HbA1c from baseline and percentage of patients who returned to normal measure: The change in waist circumference from baseline measure: The change in BMI from baseline measure: The change in WHR from baseline measure: The change in WHtR from baseline measure: The change in blood pressure from baseline measure: Changes in appetite VAS score from baseline measure: The change in FINS from baseline measure: The change in HOMA-IR from baseline measure: The change in HOMA-β from baseline measure: The change in Serum total cholesterol from baseline measure: The change in Triglyceride from baseline measure: The change in Low-Density Lipoprotein Cholesterol from baseline measure: The change in High-Density Lipoprotein Cholesterol from baseline measure: The change in Serum Uric Acid from baseline measure: Changes of the score of the European five-dimensional Health scale (EQ-5D-5L) compared with the baseline. measure: Changes of the PHQ-4 score from the baseline. measure: Expectance assessment measure: Assessment of belief in acupuncture measure: Blinding assessment measure: Safety assessment measure: Adherence assessment of acupuncture measure: Adherence assessment of life modification sex: ALL minimumAge: 18 Years maximumAge: 64 Years stdAges: ADULT facility: Guang'anmen Hospital, China Academy of Chinese Medical Sciences city: Beijing country: China name: Zhishun Liu, PhD role: CONTACT phone: +861088002331 email: [email protected] lat: 39.9075 lon: 116.39723 hasResults: False
|
<|newrecord|> nctId: NCT06359405 id: UBeykentUni briefTitle: Evaluation of Nursing Students' Crisis Management Skills in Medication Safety Simulation acronym: RCS overallStatus: NOT_YET_RECRUITING date: 2024-04-20 date: 2024-05-01 date: 2024-05-02 date: 2024-04-11 date: 2024-04-16 name: University of Beykent class: OTHER briefSummary: This study aims to objectively evaluate student nurses' crisis management skills in drug safety simulation and examine an effective intervention to improve these skills through a randomized controlled study. The research aims to provide important findings that will contribute to the determination of strategies to increase the competencies of student nurses in the fields of drug safety and crisis management.
|
Research Hypotheses:
|
H1: The application of drug safety simulation has an effect on the crisis management skill level of nursing students.
|
The aim of the intervention is to develop a simulation program to enhance nursing students' crisis management skills in drug safety. This simulation program will provide students with the opportunity to recognize, assess, and effectively intervene in medication errors in real-world scenarios.
|
The simulation program will include interactive case scenarios, virtual patients, and simulation sessions led by an instructor providing feedback to students. Additionally, learning materials covering topics such as prevention, recognition, and correction of medication errors will be provided conditions: Nurse studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This study was planned as a randomized controlled study to evaluate the crisis management skills of student nurses in drug safety simulation. primaryPurpose: HEALTH_SERVICES_RESEARCH masking: SINGLE maskingDescription: The researchers declare that the data obtained from randomly formed groups will be numbered and entered into the statistical analysis program to hide the identity information and that two researchers will be assigned during the entry. whoMasked: PARTICIPANT count: 70 type: ESTIMATED name: drug safety simulation measure: The effect of drug safety simulation application on the crisis management skill level of nursing students. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
|
<|newrecord|> nctId: NCT06359392 id: DNZNC466DGR7 id: 1R21NR020383-01 type: NIH link: https://reporter.nih.gov/quickSearch/1R21NR020383-01 briefTitle: Palliative Care Messaging for American Indians overallStatus: NOT_YET_RECRUITING date: 2024-04-08 date: 2024-05-15 date: 2024-05-15 date: 2024-04-11 date: 2024-04-11 name: South Dakota State University class: OTHER name: Great Plains Tribal Leaders Health Board name: National Institute of Nursing Research (NINR) briefSummary: The investigators will be conducting a randomized trial in 3 reservation communities to test the efficacy of the narrative as culture-centric health promotion model for increasing American Indian tribal members' palliative care knowledge and intentions to discuss palliative care. conditions: Knowledge, Attitudes, Practice studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 360 type: ESTIMATED name: No message name: Culture-centric message name: General messge measure: Palliative Care Knowledge Scale (PaCKS) measure: Knowledge of Care Options (KOCO) measure: Hospice and Palliative Care Questionnaire (HPCQ) measure: Identification and Transportation with Palliative Care Message measure: Attitudes and Intentions to Discuss Palliative Care sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: South Dakota State University city: Rapid City state: South Dakota zip: 57701 country: United States name: Mary J Isaacson, PhD, RN, RHNC, CHPN, FPCN role: CONTACT phone: 605-670-0975 email: [email protected] name: Karla Hunter, PhD role: CONTACT phone: 605-212-0894 email: [email protected] name: Mary J Isaacson, PhD, RN, RHNC, CHPN, FPCN role: PRINCIPAL_INVESTIGATOR lat: 44.08054 lon: -103.23101 hasResults: False
|
<|newrecord|> nctId: NCT06359379 id: S22-11168 briefTitle: Ropidoxuridine as a Radiosensitizer in Newly Diagnosed IDH-Wildtype Glioblastoma With Unmethylated MGMT Promoter overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2026-08 date: 2027-02 date: 2024-04-11 date: 2024-04-11 name: Shuttle Pharmaceuticals, Inc. class: INDUSTRY briefSummary: This is a randomized, open-label, phase 2 study evaluating the safety and efficacy of oral ropidoxuridine as a radiation-sensitizing agent in patients with newly diagnosed wild-type isocitrate dehydrogenase glioblastoma with an unmethylated O6-methylguanine-DNA methyltransferase promoter, undergoing standard 60 Gy radiotherapy. conditions: Glioblastoma, IDH-wildtype studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 54 type: ESTIMATED name: Ropidoxuridine measure: Number of patients treated with oral ropidoxuridine at dose levels of 960 and 1200 mg once daily, with treatment-related adverse events assessed by CTCAE v5.0. measure: adiographic response rate, disease control rate, best overall response, and duration of overall response in patients treated with oral ropidoxuridine at 960 and 1200 mg daily doses, assessed using the Response Assessment in Neuro-Oncology criteria. measure: Maximum plasma concentration for orally administered ropidoxuridine, at dose levels of 960 and 1200 mg once daily. measure: Trough plasma concentration of orally administered ropidoxuridine, at dose levels of 960 and 1200 mg once daily measure: Time to maximum plasma concentration for orally administered ropidoxuridine, at dose levels of 960 and 1200 mg once daily. measure: Area under the curve for orally administered ropidoxuridine, at dose levels of 960 and 1200 mg once daily. measure: Half-life for orally administered ropidoxuridine, at dose levels of 960 and 1200 mg once daily. measure: Overall survival at 12 months measure: Radiographic Response Rate measure: Disease Control Rate measure: Best Overall Response measure: Duration of Response measure: Overall Survival measure: Progression-Free Survival measure: Six-Month Progression-Free Survival measure: Fraction of patients with tumor progression outside of the treatment area. measure: Quantification of 9 relevant neurologic domains based on the NANO scale. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Lombardi Comprehensive Cancer Center at Georgetown University city: Washington state: District of Columbia zip: 20007 country: United States lat: 38.89511 lon: -77.03637 facility: Sylvester Comprehensive Cancer Center city: Miami state: Florida zip: 33136 country: United States lat: 25.77427 lon: -80.19366 facility: John Theurer Cancer Center at the Hackensack University Medical Center city: Hackensack state: New Jersey zip: 07601 country: United States lat: 40.88593 lon: -74.04347 facility: Memorial Sloan Kettering Cancer Center city: New York state: New York zip: 10065 country: United States lat: 40.71427 lon: -74.00597 facility: Allegheny General Hospital city: Pittsburgh state: Pennsylvania zip: 15212 country: United States lat: 40.44062 lon: -79.99589 facility: University of Virginia city: Charlottesville state: Virginia zip: 22903 country: United States lat: 38.02931 lon: -78.47668 hasResults: False
|
<|newrecord|> nctId: NCT06359366 id: ShenzhenH-guo briefTitle: Perineal Massage Combined With Hip Joint Training overallStatus: NOT_YET_RECRUITING date: 2024-04-10 date: 2024-07-31 date: 2024-08-31 date: 2024-04-11 date: 2024-04-11 name: Shenzhen Hospital of Southern Medical University class: OTHER briefSummary: The goal of this clinical trial is to learn if perineal massage combined with hip joint training works to improve pelvic function (urinary incontinence, constipation and hip motion) in pregnant women. The main questions it aims to answer are:
|
Does the perineal massage combined with hip joint training lower the prevalence of participants who have urinary incontinence and constipation? Does the perineal massage combined with hip joint training improve the flexibility of the hip joint? Researchers will compare an intervention (perineal massage combined with hip joint training) to a comparison(regular training and treatment) to see if the intervention (perineal massage combined with hip joint training) works to improve pelvic function.
|
Participants will:
|
receive the intervention (perineal massage combined with hip joint training ) or regular training and treatment fifth a week at 36 weeks gestation before participants receive first-time intervention, they complete Demographic sociological , ICI-Q-LF, Wexner constipation and hip motion questionnaires conditions: Pelvic Floor Disorders studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: when the participants are enrolled in this study, they will be allocated to groups randomly by an independent researcher and sign the consent form. The care providers will not know the outcomes of this study, they just provide treatment for pregnant women; therefore, the care providers could be masked. an independent investigator will send a questionnaire to the participant, and the investigator does not know the intervention participants received; thus they could be masked. whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 108 type: ESTIMATED name: perineal massage combined hip joint training measure: pelvic floor function(constipation) measure: pelvic floor function (urinary incontinence score) measure: hip motion sex: FEMALE minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT hasResults: False
|
<|newrecord|> nctId: NCT06359353 id: B-1902-520-004 briefTitle: Effect of Pitavastatin on Bone overallStatus: COMPLETED date: 2019-04-08 date: 2022-02-10 date: 2023-12-19 date: 2024-04-11 date: 2024-04-11 name: Seoul National University Bundang Hospital class: OTHER name: JW Pharmaceutical briefSummary: This clinical trial investigates the effects of pitavastatin on bone health in postmenopausal women with osteopenia or osteoporosis and hypercholesterolemia. Given the high prevalence of osteoporosis in aging populations and the associated risks, even with existing treatments, this study addresses a critical gap in medical research. Statins, specifically HMG-CoA reductase inhibitors, are suggested to benefit bone metabolism by promoting bone formation and reducing resorption. However, the specific impact of pitavastatin on bone metabolism lacks clinical evidence.
|
The study's primary goal is to determine the effects of a 12-month pitavastatin regimen on bone metabolism markers in this population. This research could significantly contribute to developing more effective osteoporosis treatments for postmenopausal women, combining bone health and cholesterol management strategies. conditions: Osteoporosis, Osteopenia conditions: Hypercholesterolemia conditions: Menopausal Osteoporosis studyType: INTERVENTIONAL phases: PHASE4 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: PREVENTION masking: NONE count: 70 type: ACTUAL name: Pitavastatin measure: Change in blood urinary N-Telopeptide of Type I Collagen levels compared to baseline after 6 months measure: Change in blood C-Telopeptide of Type I Collagen levels measure: Change in blood Osteocalcin levels measure: Change in urinary N-Telopeptide of Type I Collagen levels measure: Change in blood Procollagen Type 1 N-Terminal Propeptide levels measure: Change in blood LDL-cholesterol levels measure: Change in blood HbA1c levels measure: Changes in bone mineral density measure: Changes of the outcomes after 12 months sex: FEMALE maximumAge: 75 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Seoul National University Bundang Hospital city: Seongnam state: Gyeonggi zip: 463-707 country: Korea, Republic of lat: 37.43861 lon: 127.13778 hasResults: False
|
<|newrecord|> nctId: NCT06359340 id: OBOT-2018C2-13158 briefTitle: Therapy and Peer Support for Patients Taking Medication for Opioid Use Disorder overallStatus: RECRUITING date: 2020-03-13 date: 2024-04-30 date: 2025-04-30 date: 2024-04-11 date: 2024-04-11 name: Public Health Management Corporation class: OTHER name: Boston University name: Patient-Centered Outcomes Research Institute name: Philadelphia College of Osteopathic Medicine name: University of Pennsylvania briefSummary: Current clinical guidelines for medication assisted treatment (MAT) of opioid use disorder (OUD) recommend that treatment include a psychosocial component to help address psychological factors related to addiction. However, a knowledge gap exists regarding the most effective forms of psychosocial intervention and what interventions are most effective for different types of patients. This gap represents a significant barrier to the widespread implementation of effective office-based opioid treatment (OBOT) with buprenorphine, which is important to improving opioid treatment and responding to the critical needs of individuals living with OUD. The overarching goal of this patient-centered research is to address the diverse needs and preferences of OUD patients in regards to psychosocial approaches and to overcome the "one-size-fits-all" strategies that are typically used to treat OUD. Importantly, the investigators arrived at this goal, in part, through collaboration and consultation with former patients who have received different types of treatments for OUD. In this manner, patients provided important insight to inform the selection of interventions to be evaluated, patient characteristics that may differentially impact the effects of the interventions, and the patient outcomes to be examined. conditions: Opioid-use Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: FACTORIAL primaryPurpose: TREATMENT masking: NONE count: 440 type: ESTIMATED name: Psychosocial treatment measure: Changes in urinalysis-confirmed opioid use from baseline through one year post-study entry measure: Days Retained in Office-Based Buprenorphine Treatment measure: Changes in quality of life assessment: Short Form-36 (SF-36) from baseline through one year post-study entry measure: Changes in multidimensional problem severity from baseline through one year post-study entry measure: Changes in the percentage of individuals engaging in urinalysis-confirmed use of other (non-opioid) drugs from baseline to one year post-study entry measure: Changes in ED utilization from baseline to one year post-study entry measure: Changes in opioid overdose rates measure: Changes in treatment satisfaction from baseline to one year post-study entry measure: Job satisfaction and stress sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Philadelphia College of Osteopathic Medicine status: RECRUITING city: Philadelphia state: Pennsylvania zip: 19131 country: United States name: David S Festinger, Ph.D. role: CONTACT phone: 215-871-6546 email: [email protected] lat: 39.95233 lon: -75.16379 hasResults: False
|
<|newrecord|> nctId: NCT06359327 id: Pro00075623 briefTitle: Effect of Consumption of Pep19 on Quality of Life overallStatus: RECRUITING date: 2024-04-17 date: 2024-07-17 date: 2024-08-15 date: 2024-04-11 date: 2024-04-19 name: Proteimax Biotechnology Israel LTD class: INDUSTRY briefSummary: Pep19 is a naturally occurring peptide (protein) that triggers loss of body fat. It has been certified Generally Recognized as Safe (GRAS) at up to 3.8 grams per day and may be included in various foods. Pep19 has no effect on the brain, heart, pancreas or skeletal muscle. It is highly purified, not allergenic or mutagenic, and free of microbes, metals and other contaminants. Preliminary, open-label, uncontrolled studies have shown that Pep19 is well tolerated in rodents, dogs, and humans. This placebo-controlled study will evaluate the effects of two doses of Pep19™ -- 2 mg and 5 mg - on quality of life and sleep quality in obese subjects. conditions: Quality of Life conditions: Obesity conditions: Sleep Quality studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: SINGLE whoMasked: PARTICIPANT count: 24 type: ESTIMATED name: Placebo name: Pep19 2 mg name: Pep19 5 mg measure: Improvement on QoL measure: Improvement on Sleep quality measure: Temperature measure: Blood pressure measure: Heart rate measure: circumference measure: blood tests measure: Body fat measure: Body weight sex: ALL minimumAge: 40 Years maximumAge: 60 Years stdAges: ADULT facility: Precision Clinical Research, LLC status: RECRUITING city: Sunrise state: Florida zip: 33351 country: United States name: Jason Haffizulla, MD role: CONTACT lat: 26.13397 lon: -80.1131 hasResults: False
|
<|newrecord|> nctId: NCT06359314 id: STU00219362 briefTitle: Anxiety Lowering and Deprescribing Through Emotion Regulation acronym: ALDER overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-07 date: 2024-07 date: 2024-04-11 date: 2024-04-11 name: Northwestern University class: OTHER briefSummary: The goal of this clinical trial is to test ALDER (Anxiety Lowering and Deprescribing through Emotion Regulation), an online self-guided positive emotion intervention, in patients over the age of 65 who are candidates for benzodiazepine receptor agonist (BZRA, commonly called benzos, or z-drugs) deprescribing. The main questions it aims to answer are:
|
* Is ALDER relevant to and satisfactory for older adult BZRA users?
|
* Does ALDER help to increase positive emotions and decrease anxiety, trouble sleeping, and use of BZRA medications?
|
Participants will complete the 5-week online self-guided ALDER intervention as well as two survey assessments, one before the intervention and one after. conditions: Benzodiazepine Dependence conditions: Anxiety Disorders conditions: Sleep Disturbance studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 40 type: ESTIMATED name: ALDER measure: Feasibility of intervention measure: Acceptability of intervention measure: Adoption of intervention measure: Patient benzodiazepine receptor agonist (BZRA) use measure: Patient attitude towards deprescribing BZRAs measure: Patient-reported sleep disturbance measure: Patient-reported anxiety measure: Patient-reported stress measure: Patient-reported depression measure: Patient-reported positive affect measure: Patient-reported meaning and purpose measure: Patient-reported comorbidities sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT hasResults: False
|
<|newrecord|> nctId: NCT06359301 id: H-34 briefTitle: H-34 DELTA Revision Cup overallStatus: RECRUITING date: 2021-09-14 date: 2026-03-31 date: 2029-03-31 date: 2024-04-11 date: 2024-04-11 name: Limacorporate S.p.a class: INDUSTRY briefSummary: THis study is aimed to provide a clinical and radiographic evaluation of 49 suitable subjects who underwent a total hip arthroplasty with DELTA Revision acetabular cup. conditions: Hip, Osteoarthritis studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 49 type: ESTIMATED name: DELTA Revision acetabular cup measure: Harris Hip Score (HHS) measure: ROM measurement measure: Oxforn Hip Score (OHS) measure: Survival rate measure: Radiographic implant evaluation and stability assessment of the DELTA Revision acetabular cup measure: Incidence, type and severity of all the Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Device Effects (ADEs), and Serious Adverse Device Effects (SADEs) occurred at each follow-up sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Samodzielny Publiczny Szpital Kliniczny im. Prof. Adama Grucy CMKP status: RECRUITING city: Otwock zip: 05-400 country: Poland name: Jerzy Bialecki role: CONTACT lat: 52.10577 lon: 21.26129 hasResults: False
|
<|newrecord|> nctId: NCT06359288 id: 2023/01.11/2023/6 briefTitle: Preterm Newborn Mothers' Anxiety and Self-Efficacy overallStatus: COMPLETED date: 2023-01-01 date: 2023-12-01 date: 2024-03-23 date: 2024-04-11 date: 2024-04-11 name: Kocaeli University class: OTHER briefSummary: The aim of this study was to evaluate the effect of QR code supported infant care training given to mothers of preterm newborns on maternal self-efficacy and maternal anxiety level . conditions: Nursing Care conditions: Mother-Infant Interaction conditions: Education studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The study was conducted experimentally with a pre-test and post-test control group. primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE maskingDescription: Double blinding was used in the study. For this purpose, the participants were not specified in which group they belonged to the research. Therefore, a separate informed consent form was prepared for each group. In order to avoid bias in the analysis of the research data, statistician blinding was also applied.
|
While coding the research data, the research groups were coded as A and B, and the statistician was prevented from knowing which letter represented which group. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 80 type: ACTUAL name: Group receiving QR code supported training measure: Perceived Maternal Self-Efficacy Scale (PMES)- Survey measure: State-Trait Anxiety Inventory (STAI)- Survey Scale sex: FEMALE minimumAge: 19 Years maximumAge: 45 Years stdAges: ADULT facility: Kocaeli University city: Kocaeli state: İzmit zip: 41380 country: Turkey lat: 39.62497 lon: 27.51145 hasResults: False
|
<|newrecord|> nctId: NCT06359275 id: iPULSAR-PC briefTitle: PD-1 Combined With Chemotherapy and PULSAR in LAPC and Local Recurrence Patients overallStatus: RECRUITING date: 2024-04-01 date: 2025-12-01 date: 2027-10-01 date: 2024-04-11 date: 2024-04-11 name: Fudan University class: OTHER briefSummary: This trial is a phase II clinical trial of the safety and efficacy of PD-1 antibody (Toripalimab) in combination with paclitaxel (albumin-bound type) and gemcitabine and PULSAR radiotherapy in patients with locally advanced unresectable pancreatic cancer and patients with only local recurrence after pancreatic cancer surgery, to observe the safety and efficacy of PD-1 antibody (Toripalimab) in combination with paclitaxel (albumin-bound type) and gemcitabine and PULSAR in the treatment of patients with locally advanced unresectable pancreatic cancer. conditions: Pancreatic Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 81 type: ESTIMATED name: PD-1 name: Nab-paclitaxel name: Gemcitabine name: PULSAR measure: Progression-free survival (PFS) measure: Progression-free survival (ORR) measure: Overall survival (OS) measure: Surgical Conversion Rate sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fudan University Shanghai Cancer Center status: RECRUITING city: Shanhai country: China name: Weijing Zhang role: CONTACT phone: 021-64175590 email: [email protected] hasResults: False
|
<|newrecord|> nctId: NCT06359262 id: KI-HAS-001 briefTitle: Evaluating the Hope@School Prevention Program acronym: Hope@School overallStatus: NOT_YET_RECRUITING date: 2027-01-01 date: 2027-12-30 date: 2028-12-30 date: 2024-04-11 date: 2024-04-11 name: Karolinska Institutet class: OTHER briefSummary: This multi-center cluster-randomized controlled trial aims to evaluate the feasibility, effectiveness and overall impact of the Hope@School (H@S) program by comparing mental health outcomes in students participating in the H@S program with students having only access to regular student health care (treatment as usual - TAU).
|
The primary objectives of the study are:
|
To determine if the H@S program is feasible, acceptable, usable and safe for students, families, teachers and school leaders To establish if the H@S program is associated with improvements in quality of life, everyday functioning, peer relations and general mental health. conditions: Mental Health Wellness 1 studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 3220 type: ESTIMATED name: Hope@School name: Treatment as usual measure: KIDSCREEN-27 Child version measure: KIDSCREEN-27 Parent version measure: Mental Health-Promoting Knowledge (MHPK-10) measure: Healthy Behaviours in School-aged Children survey protocol (HBSC) part 1 measure: Digital Addiction Scale for Children (DASC) measure: Healthy Behaviours in School-aged Children survey protocol (HBSC) part 2 sex: ALL minimumAge: 8 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT hasResults: False
|
<|newrecord|> nctId: NCT06359249 id: V.3-06/02/2024 briefTitle: Do the Symptoms of Chronic Constipation Improve With a Primary Care Programme Based on Behavioural Re-education and Abdominal Massage? overallStatus: ACTIVE_NOT_RECRUITING date: 2024-03-01 date: 2026-12-28 date: 2026-12-28 date: 2024-04-11 date: 2024-04-11 name: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina class: OTHER name: Universitat de Vic briefSummary: Constipation is one of the most common digestive problems in today's society. In Spain, it is estimated that this condition affects between 12% and 20% of the population, being more frequent in women, contributing considerably to the quality of life, to the increase of medical visits and to high costs for the health system. The objectives of the study are to reduce the rate of constipation and laxative use in the short term with a structured rehabilitation programme consisting of abdominal massage therapy and behavioural re-education, to improve the quality of life of these patients, and to assess whether the proposed treatment is effective in the short and medium term. conditions: Constipation Chronic Idiopathic studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 45 type: ESTIMATED name: change of habits name: change of habits + auto abdominal massage measure: Degree of constipation measure: Stool characteristics measure: Quality of life focused on patients with constipation measure: The number of laxatives taken by each participant measure: Other patient characteristics such as sex, age, previous conditions, and level of physical activity with the VREM questionnaire. sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Cristina Segura Bayona city: Igualada state: Barcelona zip: 08700 country: Spain lat: 41.58098 lon: 1.6172 hasResults: False
|
<|newrecord|> nctId: NCT06359236 id: 122S049 briefTitle: Development and Effectiveness of Cognitive Behavioral Therapy Based Weight Control Mobile Application "BI'KILO" overallStatus: ACTIVE_NOT_RECRUITING date: 2022-06-01 date: 2024-01-01 date: 2024-04-01 date: 2024-04-11 date: 2024-04-11 name: Eskisehir Osmangazi University class: OTHER name: The Scientific and Technological Research Council of Turkey briefSummary: The primary purpose of this project is to observe the effects of Cognitive Behavioral Psychotherapy-based weight-loss mobile application (Bi' Kilo) in 4 essential areas (Anthropometric, Biochemical, Psychometric, Cognitive) in overweight and obese individuals and to test whether these effects will persist after ten weeks. In this context, the original value of the proposed study is that a mobile application will be produced that is suitable for the culture and whose effectiveness has been scientifically proven.
|
In our current project proposal, the measurements of the participants will be evaluated holistically together with both tests and inventories, as well as physical measurements and biochemical data. In this study, the usability of the mobile application to be developed will also be evaluated and reported.
|
The study group of the research will consist of overweight and obese individuals. The first stage will be a pilot study to identify the shortcomings of the Bi'Kilo mobile application. After eliminating the deficiencies of the Bi' Kilo mobile application, a working group will be formed in the second phase of the research. At this stage, the sample will be divided into two different groups within the scope of the study and a study group and a control group will be formed.
|
The study consists of three phases as preparation, implementation, and follow-up. Measurements of the participants will be made at the beginning (Anthropometric, Biochemical, Psychometric, Cognitive), at the end of the six-week implementation phase (Anthropometric), and at the end of the four-week follow-up phase (Anthropometric, Biochemical, Psychometric, Cognitive). conditions: Weight Loss conditions: Obesity conditions: Overweight and Obesity conditions: Eating Behavior conditions: Eating Habit studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 70 type: ESTIMATED name: BI'KILO Intervention measure: Body Mass Index (BMI) measure: Weight measure: Height measure: Waist Circumference (WC) measure: Hip Circumference measure: Waist-Hip Ratio (WHR) measure: Body Fat Percentage (BFP) measure: Visceral Fat measure: Blood Glucose Level measure: Blood Insulin Level measure: Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) measure: Serum Leptin Level measure: Serum Ghrelin Level measure: Emotional Eating Scale (EES) Turkish Form measure: Mindful Eating Questionnaire (MEQ) Turkish Form measure: Modified Yale Food Addiction Scale Version 2.0 Turkish Form (mYFAS 2.0) measure: Motor Screening Task (MOT) measure: Spatial Working Memory (SWM) measure: Stop Signal Task (SST) measure: Rapid Visual Information Processing (RVP) measure: Cambridge Gambling Test (CGT) measure: Demographic Information Form measure: Structured Clinical Interview for DSM-5 Disorders (SCID-5) measure: The Eating Disorder Assessment for DSM-5 (EDA-5) measure: Blood ACTH Level (ACTH) measure: Blood Growth Hormone Level (GH) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Eskisehir Osmangazi University Faculty of Medicine city: Eskişehir country: Turkey lat: 39.77667 lon: 30.52056 hasResults: False
|
<|newrecord|> nctId: NCT06359223 id: 2400602 briefTitle: Effect of Coffee Consumption on Pain and Intestinal Motility After Caesarean Section: overallStatus: NOT_YET_RECRUITING date: 2024-04-20 date: 2024-07-15 date: 2024-12-30 date: 2024-04-11 date: 2024-04-11 name: TC Erciyes University class: OTHER briefSummary: Purpose: It will be performed to minimize the problems that the mother and the newborn may experience in the postpartum period by eliminating the negative symptoms related to postpartum pain and delayed intestinal motility.
|
Design: It will be conducted as a randomized controlled experimental study. Method: It will consist of women who had cesarean section surgery at Necmettin Erbakan University Faculty of Medicine Hospital between April and July 2024. The sample of the research; The sample will consist of women who meet the selection criteria and voluntarily agree to participate in the research. Considering the possible 10% data loss in randomized controlled studies, a total of 50 women, 25 in each group, were planned to be sampled. Data will be collected using a personal information form and visual pain scale (VAS). . Immediately before coffee application (6-12-18 hours after surgery), women\'s pain intensity and bowel motility will be evaluated. Women will then be asked to consume 100 ml of unsweetened caffeinated coffee at 6, 12 and 18 hours after surgery. 6,12,18. Half an hour after coffee consumption, women will be evaluated for pain using VAS. In the control group, no procedure will be applied and pain assessment will be made with VAS at the same hours.
|
Conclusion: It is aimed to reduce the pain and increase intestinal motility of patients who consume coffee after cesarean section.
|
Key Words: Caesarean Section, Coffee, Pain, Motility conditions: Operation conditions: Cesarean Section studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 50 type: ESTIMATED name: coffee consumption name: control group measure: Postoperative Pain measure: intestinal motility sex: FEMALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: KTO Karatay Unıversty city: Konya state: Karatay zip: 42000 country: Turkey name: HÜMEYRA YÜKSEL, Ph.D Student role: PRINCIPAL_INVESTIGATOR name: Hafize Tüzmen, Ph.D student role: SUB_INVESTIGATOR name: Merve Yazar, Ph.D student role: SUB_INVESTIGATOR name: Jule Horasanlı, MD role: SUB_INVESTIGATOR name: Serap Sayar, Assis. Prof. role: SUB_INVESTIGATOR lat: 37.87135 lon: 32.48464 hasResults: False
|
<|newrecord|> nctId: NCT06359210 id: 4973 id: 4R33CA256656-03 type: NIH link: https://reporter.nih.gov/quickSearch/4R33CA256656-03 briefTitle: Sustaining Physical Activity After Cancer Exercise Sessions acronym: SPAACES overallStatus: RECRUITING date: 2024-03-04 date: 2026-03-01 date: 2026-12-31 date: 2024-04-11 date: 2024-04-11 name: Colorado State University class: OTHER name: National Cancer Institute (NCI) briefSummary: The goal of this clinical trial is to develop and test an adaptive physical activity (PA) maintenance intervention for cancer survivors, after participating in a community-based exercise oncology program. The main questions it aims to answer are:
|
* Aim 1: Examine the feasibility and acceptability of the intervention among cancer survivors and community partners. The researchers will utilize quantitative surveys, focus groups, and semi-structured interviews to collect information about feasibility, implementation, adaptation, and sustainability.
|
* Aim 2: Examine the effects of the intervention among cancer survivors. The researchers will compare the proportion of participants achieving the exercise guidelines for cancer survivors six-months following completion of the initial exercise program.
|
Participants will participate in a community-based exercise oncology program and then return to three months of free living. Based on the PA measured at the three-month follow-up, participants will be categorized as a "Responder" or "Incomplete Responder", and then randomized to the PA maintenance intervention. Researchers will compare those that are classified as Responders (meeting exercise guidelines for cancer survivors) and Incomplete Responders (not meeting guidelines for cancer survivors) to see what level of intervention is needed to influence sustainable behavior change in this population. conditions: Exercise Oncology conditions: Physical Activity Behavior conditions: Behavior Change Interventions studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: An adaptive design results in a final total of 4 possible subgroups, depending upon responder/non-responder status, and researchers plan to compare the proportion of participants achieving the minimum exercise guidelines for cancer survivors within the responders and incomplete responder subgroups. Admittedly however, it is not possible to fully elucidate the analyses the researchers will conduct, as researchers cannot predict the number of subgroups that participants will represent at the end of the trial (e.g., if there are no "incomplete responders" the design reduces to randomization to only two groups), nor the number of participants who will be in those subgroups primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 105 type: ESTIMATED name: Responder Monthly Behavior Change Discussion Sessions name: Incomplete Responder Monthly Behavior Change Discussion Sessions name: Incomplete Responder Monthly Behavior Change Discussion Sessions + Bi-Weekly Exercise Sessions measure: Physical Activity program measure: Quality of Life (QOL) measure: Physical Fitness - Aerobic measure: Physical Fitness - muscular strength and endurance measure: Feasibility and acceptability of the PA maintenance intervention components sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Anschutz Medical Center status: NOT_YET_RECRUITING city: Aurora state: Colorado zip: 80045 country: United States name: Ryan Marker, PhD, PT role: CONTACT phone: 720-848-0300 email: [email protected] name: Ryan Marker, PhD, PT role: SUB_INVESTIGATOR lat: 39.72943 lon: -104.83192 facility: Colorado State University status: RECRUITING city: Fort Collins state: Colorado zip: 80526 country: United States name: Heather J Leach, PhD role: CONTACT phone: 970-491-8951 email: [email protected] name: Heather J Leach, PhD role: PRINCIPAL_INVESTIGATOR lat: 40.58526 lon: -105.08442 facility: University of Wyoming status: RECRUITING city: Laramie state: Wyoming zip: 82072 country: United States name: Derek Smith, PhD role: CONTACT phone: 307-766-5271 email: [email protected] name: Derek Smith, PhD role: SUB_INVESTIGATOR lat: 41.31137 lon: -105.5911 hasResults: False
|
<|newrecord|> nctId: NCT06359197 id: 2024-17022-GRA briefTitle: Effect of Caffeine Consumption on Protein Biomarkers and Cardiovascular Disease overallStatus: NOT_YET_RECRUITING date: 2024-04-08 date: 2024-08-10 date: 2025-06-01 date: 2024-04-11 date: 2024-04-11 name: Hamilton Health Sciences Corporation class: OTHER briefSummary: Caffeine is one of the most widely consumed substances worldwide. This study looks to test and measure the changes in different biomarkers in the blood before and after having caffeine using capillary and venous blood sampling methods. A biomarker is a measurable indicator of biological processes. The primary goal of this clinical trial is to evaluate participant rate and adherence. It will also learn about how caffeine affects different biomarkers that may be related to cardiovascular disease. Finally, it will assess the accuracy of the capillary blood samples compared to the venous blood samples. The main questions it aims to answer are:
|
* What is the feasibility of recruiting and retaining participants?
|
* Are the study procedures appropriate to be translated to a larger future study?
|
Researchers will compare caffeine to a placebo (a look-alike substance that contains no drug) to see if
|
Participants will:
|
* Be randomly assigned to the control group or the caffeine group. Individuals in the control group will be taking a placebo pill with no effect and those in the caffeine group will be taking 400mg of caffeine in pill form.
|
* Be asked to undergo a fast of at least 8 hours overnight before taking two placebo pills or the 400 mg of caffeine via two caffeine pills. They will be required to stay fasted for 6 hours after taking the pill as well. The total time fasted will be at least 14 hours.
|
* Have blood collected using three different methods before taking the two pills, 3 hours after taking the pills and 6 hours after taking the pills. The 3 methods include intravenous (IV) blood sampling, finger prick and collection on Whatman 903 Protein Saver Card and collection using the TASSO+ device. The TASSO+ blood collection device is a small capillary blood collection device that is designed to be easy to use and able to be used outside of a hospital/lab setting. Whatman 903 Protein Saver Cards are special filter paper with five circles for samples, that are designed for the collection and storage of blood. conditions: Healthy studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: An external party will prepare an equal number of kits (n=18) containing all the required materials for the participants, both in the placebo and caffeine group. They will assign a unique random number to each of the packages; each number will correlate to either the placebo or caffeine group. When a participant agrees to the study, they will be given a unique participant ID number ranging from 0-36. Then, the external party will use a random number generator to pick the kit given to that participant. They will record the number associated with that kit, and link the kit number to the participant ID for tracking purposes. At the end of the study, the investigators will determine which participants received caffeine vs placebo based on the assigned random numbers. primaryPurpose: OTHER masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 36 type: ESTIMATED name: Caffeine Pill name: Placebo name: TASSO+ Device name: Finger prick and collection on Whatman Protein 903 Saver Cards name: Intravenous Sampling measure: Participant rate measure: Participant Adherence measure: Participant satisfaction measure: Significant changes in biomarkers observed after the ingestion of caffeine measure: Determine the correlation between capillary sampling and intravenous sampling measure: Determine the stability of capillary samples sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: David Braley Research Institute city: Hamilton state: Ontario zip: L8L 2X2 country: Canada name: Luca Malatesta role: CONTACT phone: 905-527-4322 phoneExt: 40311 email: [email protected] name: Megan Robertson role: CONTACT phone: 905-527-527-4322 phoneExt: 40311 email: [email protected] name: Guillaume Pare, MD role: PRINCIPAL_INVESTIGATOR lat: 43.25011 lon: -79.84963 facility: Hamilton General Hospital city: Hamilton state: Ontario zip: L8L 2X2 country: Canada name: Luca Malatesta role: CONTACT phone: 905-527-4322 phoneExt: 40311 email: [email protected] name: Megan Robertson role: CONTACT phone: 905-527-4322 phoneExt: 40311 email: [email protected] name: Guillaume Pare, MD role: PRINCIPAL_INVESTIGATOR lat: 43.25011 lon: -79.84963 facility: McMaster University, Department of Pathology and Molecular Medicine city: Hamilton state: Ontario zip: L8S 4L8 country: Canada name: Luca Malatesta role: CONTACT phone: 905-527-4322 phoneExt: 40311 email: [email protected] name: Megan Robertson role: CONTACT phone: 905-527-4322 phoneExt: 40311 email: [email protected] name: Guillaume Pare, MD role: PRINCIPAL_INVESTIGATOR lat: 43.25011 lon: -79.84963 hasResults: False
|
<|newrecord|> nctId: NCT06359184 id: GO21/1011 briefTitle: Yoga, Mother's Stress and Baby overallStatus: COMPLETED date: 2023-11-01 date: 2024-02-01 date: 2024-02-15 date: 2024-04-11 date: 2024-04-11 name: Hacettepe University class: OTHER briefSummary: The aim of this study is to examine the effects of yoga on the stress of mothers with babies with sleep and feeding problems, the mother-infant relationship, and the sleep and nutrition of the mother and the baby. 55 mothers with babies with sleep and feeding problems were included in the study. Mothers were randomly divided into two groups: yoga (n=29) and control group (n=26). Yoga training was applied to 29 mothers in the study group via video conferencing, 2 days a week, 1 hour a day for 8 weeks, while the mothers in the control group were given second evaluations 8 weeks after the first evaluation, without any intervention. Mothers were evaluated with the Perceived Stress Scale (PSS) for stress levels, with Parent-Child Containing Function Scale for the mother-infant relationship, with the Infancy and Early Childhood Feeding Process Mother'sAttitudes Scale for their attitudes towards the feeding process of their babies, and with Attitude Scale for Healthy Nutrition (ASHN) for their own nutrition attitudes, with Pittsburg Sleep Quality (PSQI) for sleep quality and babies with Infancy Period Adaptive Eating Behavior Scale for feeding problems, with Brief Infant/Child Sleep Questionnaire (BISQ) for sleep problems. conditions: Mother-Child Relations studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: PARTICIPANT count: 55 type: ACTUAL name: yoga name: control measure: Perceived Stress Scale (PSS) measure: Infancy and Early Childhood Feeding Process Mother's Attitudes Scale measure: Pittsburg Sleep Quality (PSQI) measure: Period Adaptive Eating Behavior Scale measure: Brief Infant/Child Sleep Questionnaire (BISQ) sex: FEMALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Ayşe Nur Ozan city: Istanbul state: Sarıyer zip: 34460 country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False
|
Subsets and Splits
No community queries yet
The top public SQL queries from the community will appear here once available.