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The study lasts approximately 40 weeks separated into a screening, treatment, and follow-up phase. Researchers determine if it is safe for the you to receive the drug and if you are eligible for the study during Screening. If eligible for the study, the treatment phase lasts 24 weeks (or six months) with one follow-up visit 12 weeks after the last visit in the treatment phase. |
During the treatment phase, participants will be asked to come to clinic every two weeks for the first month of treatment, and monthly thereafter for a total of eight treatment visits. Participants will be asked to: |
* Complete questionnaires asking about the effect of HS in their daily lives and their perception of HS and treatment received. |
* Receive related medical evaluation |
* Receive the study drug intravenously |
* Stay 20 minutes after the infusion for monitoring conditions: Hidradenitis Suppurativa conditions: Acne Inversa conditions: Hidradenitis studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: All study participants, if eligible, will receive the study drug (anifrolumab). primaryPurpose: TREATMENT masking: NONE count: 15 type: ESTIMATED name: Anifrolumab measure: Percentage of participants achieving at least a Hidradenitis Suppurativa Clinical Response score of 50 (HiSCR 50) at 12 weeks measure: Percentage of participants achieving a HiSCR 50 at 24 weeks measure: Percentage of participants who achieve a Hidradenitis Suppurativa Clinical Response score of 75 (HiSCR 75) at 12 weeks measure: Percentage of participants who achieve a HiSCR 75 at 24 weeks of treatment. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UNC Dermatology and Skin Cancer Center city: Chapel Hill state: North Carolina zip: 27516 country: United States name: Erika Hanami role: CONTACT phone: 984-974-3682 email: [email protected] name: Christopher Sayed, MD role: PRINCIPAL_INVESTIGATOR lat: 35.9132 lon: -79.05584 hasResults: False |
<|newrecord|> nctId: NCT06374199 id: 24-0181 briefTitle: Med-South Lifestyle Program for Pregnancy overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-01 date: 2025-01 date: 2024-04-18 date: 2024-04-18 name: University of North Carolina, Chapel Hill class: OTHER briefSummary: Eating a Mediterranean-style diet during pregnancy improves pregnancy outcomes, yet most Americans who are pregnant do not follow this type of dietary pattern. There is increasing interest in Food is Medicine programs, which provides foods to patients to improve health outcomes - food provided in this context is called medically tailored meals. The research team at the UNC Center for Health Promotion and Disease Prevention is developing a Food is Medicine program to improve pregnancy outcomes and at this point the team is ready to test the program. |
The purpose of this study is to assess the feasibility and acceptability of a Food is Medicine intervention when started during the first trimester of pregnancy. The eating pattern to be evaluated in this study is a Mediterranean-style dietary pattern adapted for the southern United States - thus, the program is called "Med-South." All who take part will receive Med-South dietary counseling. In addition, to help participants follow a Med-style dietary pattern, one group of study participants will receive extra virgin olive oil and nuts. The other group will receive extra virgin olive oil, nuts, and frozen meals (medically tailored meals) that align with the Med-South dietary pattern. Participants will be assigned at random (like flipping a coin) to one of these groups conditions: Pregnancy Complications studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Standard 2 group parallel randomized trial study design. primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: Med-South Lifestyle Intervention for Pregnancy--Arm 1 name: Med-South Lifestyle Intervention for Pregnancy--Arm 2 measure: Percent that would recommend this program to others who are pregnancy measure: Percent of participants who take part in the 10 study counseling sessions measure: Maternal diet quality measure: skin carotenoids sex: FEMALE minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Center for Health Promotion and Disease Prevention/UNC-Chapel Hill city: Chapel Hill state: North Carolina zip: 27599 country: United States lat: 35.9132 lon: -79.05584 hasResults: False |
<|newrecord|> nctId: NCT06374186 id: 2095072 id: 2095072 type: OTHER domain: UMKC IRB briefTitle: Continuous Glucose Monitoring, Contingency Management, and Motivational Interviewing for Patients With Type 2 Diabetes in Kansas City acronym: COMMITTED2-KC overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-12-31 date: 2025-04-08 date: 2024-04-18 date: 2024-04-18 name: University of Missouri, Kansas City class: OTHER briefSummary: This study is evaluating a behavioral treatment program that uses diabetes coaching and financial rewards in addition to continuous glucose monitoring to improve diabetes management in adult patients with type 2 diabetes. This study will evaluate if this behavioral treatment program increases individual adherence to a diabetes treatment plan and improves blood sugar management. conditions: Type 2 Diabetes studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A randomized parallel-group pilot study of a combination intervention using Motivational Interviewing (MI) and Contingency Management (CM) for patients with T2DM. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Because this is a behavioral intervention, participant blinding is not possible. Randomization will occur after baseline assessment and participants will be instructed to not tell their provider their assigned condition. whoMasked: CARE_PROVIDER count: 40 type: ESTIMATED name: Behavioral Intervention with financial rewards and coaching name: Control measure: Time in target blood glucose range per CGM measure: Hemoglobin A1C measure: Diabetes Quality of Life Brief Inventory measure: Diabetes Distress Scale measure: PROMIS Medication Adherence Scale measure: Perceived Dietary Adherence Questionnaire measure: Motivation and Confidence Ruler sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Missouri - Kansas City School of Medicine city: Kansas City state: Missouri zip: 64108 country: United States name: Carrie R Kriz role: CONTACT phone: 816-512-7473 email: [email protected] name: Jared M Bruce, PhD role: PRINCIPAL_INVESTIGATOR lat: 39.09973 lon: -94.57857 hasResults: False |
<|newrecord|> nctId: NCT06374173 id: TGI6-T1-01 briefTitle: A Phase 1 Study to Evaluate TGI-6 in Subjects With Locally Advanced/Metastatic Solid Tumors overallStatus: RECRUITING date: 2024-01-03 date: 2027-09 date: 2027-12 date: 2024-04-18 date: 2024-04-18 name: Hefei TG ImmunoPharma Co., Ltd. class: OTHER briefSummary: A Phase 1 Study to Evaluate TGI-6 in Subjects with Locally Advanced/Metastatic Solid Tumors conditions: Advanced or Metastatic Solid Tumors studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 123 type: ESTIMATED name: TGI-6 Injection measure: Dose-limiting Toxicity (DLT) measure: Dose-Finding measure: Frequency and Severity of Adverse Events (AE) measure: Pharmacokinetics of TGI-6 measure: Pharmacokinetics of TGI-6 measure: Number of subjects with Anti-TGI-6 antibody positive measure: Objective Response Rate (ORR) measure: Duration of Response (DoR) measure: Disease Control Rate (DCR) measure: Progression Free Survival (PFS) measure: Overall Survival (OS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Beijing Cancer Hospital status: RECRUITING city: Beijing country: China name: Hang Zhou role: CONTACT email: [email protected] lat: 39.9075 lon: 116.39723 hasResults: False |
<|newrecord|> nctId: NCT06374160 id: 70115371 briefTitle: Exercise in Patients With Advanced Non-small Cell Lung Cancer acronym: BREATH overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-04-30 date: 2026-08-31 date: 2024-04-18 date: 2024-04-18 name: University Hospital, Essen class: OTHER name: German Cancer Aid briefSummary: Lung cancer is one of the most common types of cancer in Germany, with 56,839 new cases and 45,072 deaths annually. Approximately 70% of patients with non-small cell lung cancer (NSCLC) are diagnosed at an advanced stage and suffer from comorbidities and symptoms such as fatigue, tiredness, and loss of strength. The standard first-line treatment for metastatic NSCLC includes platinum-based chemoimmunotherapy followed by immunotherapy maintenance. Exercise can have positive effects on symptoms such as shortness of breath, fatigue, quality of life, and physical fitness. However, there is a lack of current scientific evidence for the effectiveness of exercise in advanced lung cancer patients. No current trial investigated exercise in advanced NSCLC receiving immunotherapy so far. |
The BREATH-study is a prospective 3-arm randomized controlled trial (RCT). In total, the investigators plan to recruit 104 patients. A 2:1:1 randomization will be performed with three study groups: a control group and two exercise therapy groups (strength+endurance exercise/only endurance exercise). One group receives individual endurance training and the other group a combination of individual endurance and strength training. Both treatment groups will be treated twice a week for 12 weeks. The control group will initially receive standard treatment without exercise for 12 weeks and will then be randomized into one of the other two study groups with exercise twice a week for 12 weeks. This approach allows for a sufficiently large sample for comparisons between exercise therapy and the control group, as well as between the two exercise therapy approaches. |
The primary aim is to investigate the impact of exercise on V02peak. Secondarily endpoints aim to investigate changes in physical function, patient related outcomes and cardiac function before and after exercise. conditions: Advanced Lung Carcinoma conditions: First Line Treatment conditions: Second Line Treatment conditions: NSCLC Stage IV conditions: NSCLC Stage IIIB conditions: Palliative Treatment conditions: NSCLC Stage IIIC studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: BREATH is a prospective 3-arm 2:1:1 randomized controlled trial (RCT). The first arm represents the control group, which will receive the standard treatment for the first 12 weeks (recommendations for physical activity during cancer treatment). The other two arms represent the exercise groups, one group will receive individualized endurance training and the other group a combination of individualized endurance and strength training. All arms will be treated for 12 weeks. Afterwards, the patients in the control group are randomized to one of the other two study arms and then also treated twice for 12 weeks. primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 104 type: ESTIMATED name: Exercise intervention measure: Maximum oxygen uptake (VO2 peak [ml/min/kg]) measure: Functional Assessment of Chronic Illness Therapy - Fatigue (FACT-F) measure: European Organisation for Research and Treatment of Cancer (EORTC QLQ C30) measure: European Organisation for Research and Treatment of Cancer Lung cancer module (EORTC-LC13) measure: Arterial blood pressure measure: Change in ECG measure: Adherence to exercise intervention measure: Drop-out rate measure: Recruitment rate measure: Serious Adverse Event/Adverse Events measure: Therapy response measure: Treatment Toxicity measure: Treatment scheme measure: NT-pro-BNP measure: High sensitive troponin I measure: Erythrocytes measure: Hemoglobin measure: Leukocytes measure: Lymphocytes measure: Neutrophils measure: CRP measure: CYRFRA 21-1 measure: Physical function (Hypothetical One-repetition maximum) measure: Blood gas analysis pH value measure: Blood gas analysis (PAO2) measure: Blood gas analysis (SaO2) measure: Blood gas analysis (PCO2) measure: Blood gas analysis (BE) measure: Blood gas analysis (HCO3) measure: Blood gas analysis (SBCe) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: West German Cancer Center (Department of Palliative medicine and Department of Medical Oncology), University Hospital Essen city: Essen state: North Rhine-Westphalia zip: 45147 country: Germany name: Mitra Tewes, PD. Dr. role: CONTACT email: [email protected] name: Nico De Lazzari, M. Sc. role: CONTACT phone: +49 201 723-82035 email: [email protected] name: Mitra Tewes, PD. Dr. role: PRINCIPAL_INVESTIGATOR name: Marcel Wiesweg, PD. Dr. role: SUB_INVESTIGATOR name: Miriam Götte, PD. Dr. role: SUB_INVESTIGATOR name: Eva-Maria Hüßler, Dr. role: SUB_INVESTIGATOR name: Andreas Stang, Prof. Dr. role: SUB_INVESTIGATOR name: Matthias Totzeck, Prof. Dr. role: SUB_INVESTIGATOR lat: 51.45657 lon: 7.01228 hasResults: False |
<|newrecord|> nctId: NCT06374147 id: STUDY00004467 briefTitle: "Prapela® SVS Incubator Pad for Apnea of Prematurity acronym: Prapela AOP overallStatus: NOT_YET_RECRUITING date: 2024-05-15 date: 2026-06-01 date: 2026-12-31 date: 2024-04-18 date: 2024-04-18 name: Tufts Medical Center class: OTHER name: University of Alabama at Birmingham briefSummary: The study proposes to complete the development of and then establish the safety, efficacy, and clinical risk/benefit of a novel hospital incubator pad with stochastic vibrotactile stimulation (SVS) that will provide a complementary treatment and the first improvement in the clinical management of apnea of prematurity (AOP) in over 20 years. Currently, the only approved therapy for AOP is Caffeine Citrate. The SVS mattress pad can prove to be an effective, non-invasive adjunct to Caffeine Citrate for preterm infants with potential to shorten the need for respiratory support as well as overall shortened length of stay. conditions: Apnea of Prematurity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 120 type: ESTIMATED name: SVS mattress measure: Reduce apnea events by 30% or more in the three days after study entry measure: Reduce the number of days caffeine citrate is used after study entry by 3 days or more measure: Reduce the number of days of respiratory support by 3 days or more sex: ALL minimumAge: 0 Days maximumAge: 3 Months stdAges: CHILD hasResults: False |
<|newrecord|> nctId: NCT06374134 id: STUDY00004835 briefTitle: The Impact of Community and Patient Engagement Practices on Vaccine Confidence in the United States overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2024-11 date: 2025-02 date: 2024-04-18 date: 2024-04-18 name: Tufts University class: OTHER name: Merck Sharp & Dohme LLC briefSummary: The primary objective of this study is to demonstrate an empirical relationship between community- engagement practices, and between patient-centric clinical trial design, execution and communication practices, and vaccine adoption experience. |
Our hypothesis is that patient-centric clinical trial activity, and community engagement in late-stage clinical trials and early-stage commercialization, reduces vaccine hesitancy and increases vaccine confidence among health care providers overall and within diverse patient communities and ultimately drives faster vaccine adoption. conditions: Vaccine Hesitancy studyType: OBSERVATIONAL observationalModel: ECOLOGIC_OR_COMMUNITY timePerspective: RETROSPECTIVE count: 30 type: ESTIMATED name: Community Engagement Practice name: Patient-Centric Protocol Element measure: Units of Vaccine Dispensed sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06374121 id: POWER briefTitle: Kidney Perfusion With or Without Absorption acronym: POWER overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2026-06 date: 2026-06 date: 2024-04-18 date: 2024-04-18 name: Mario Negri Institute for Pharmacological Research class: OTHER briefSummary: In this single-center, pilot, prospective, randomized study, the investigators will compare the biochemical profiles of the perfusate and the functional parameters of five kidneys perfused with Integrated PerLife® system and "PerSorb ECOS-300CY ™" sorbent (adsorption groups) with the profiles of the perfusate and functional parameters of five matched kidneys perfused with Integrated PerLife® system only (non-adsorption group). Kidneys from marginal donors with a clinical indication to pre-transplant histological evaluation (donor \>70-years-old or aged 60 to 69 years but with hypertension, diabetes and/or clinical proteinuria) will be allocated to perfusion with or without adsorption using a 1:1 randomization ratio. When both donor kidneys will have a score from 0 to 4, the two kidneys will be used for two single transplants. When one kidney will have a score from 0 to 4 and the other kidney will have a score of 5 or more, and when both kidneys will have a score from 5 to 7, the two kidneys will be transplanted together into the same recipient. If one kidney will have a score from 5 to 7 and the other kidney will have a score of 8 or greater, the two kidneys will be discarded. With the use of the minimization method, the randomization will be planned in order to have the same number of single or dual transplants in the perfusion kidney groups with or without adsorption. Donor selection, kidney evaluation and allocation and recipient management will be based on per center practice. conditions: Kidney Replacement studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: To compare the biochemical profiles of the perfusate obtained from 5 kidneys treated with perfusion and concomitant adsorption, with that of the perfusate obtained from 5 kidneys treated with perfusion without adsorption. primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: PerSorb cartridge (CytoSorbents Europe GmbH, Germany) name: PerLife PerKidney measure: Oxidative stress markers measure: Acute kidney injury markers measure: Inflammatory cytokine markers measure: Complement activation markers measure: Vascular resistances measure: Perfusate sample collection sex: ALL minimumAge: 50 Years stdAges: ADULT stdAges: OLDER_ADULT facility: ASST - Papa Giovanni XXIII - U.O. Nefrologia e Dialisi/ Mario Negri Institute for Pharmacological Research - Clinical Research Center for Rare Diseases Aldo e Cele Daccò city: Bergamo state: BG zip: 24027 country: Italy lat: 45.69601 lon: 9.66721 hasResults: False |
<|newrecord|> nctId: NCT06374108 id: Neuro_Exercise briefTitle: Resistance Training and Corticospinal Excitability in Multiple Sclerosis acronym: NEXIMS overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-12-31 date: 2026-05-31 date: 2024-04-18 date: 2024-04-29 name: University of Aarhus class: OTHER name: Aarhus University Hospital name: University of Copenhagen briefSummary: The goal of the present study is to investigate effects of progressive resistance training on central nervous system functioning (corticospinal excitability (CSE)) and walking capacity in persons with multiple sclerosis (pwMS). A total of 54 pwMS will be enrolled and randomized into 1 of 3 groups: high dose resistant training (RT), low dose RT, and waitlist control. conditions: Multiple Sclerosis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 54 type: ESTIMATED name: Progressive resistance training measure: MEP/Mmax ratio measure: Muscle strength measure: Voluntary activation I measure: Voluntary activation II measure: Force Steadiness measure: Rate of Force Developement measure: Ultrasound measure: Resting Motor Threshold (rMT) measure: Active Motor Threshold (aMT) measure: MEP latency (resting) measure: MEP latency (active) measure: MEP amplitude (resting) measure: MEP amplitude (active) measure: Short-interval intracortical Inhibition (SICI) measure: Intracortical facilitation (ICF) measure: Cortical Silent Period (CSP) measure: Central Motor Conduction Time (CMCT) measure: EEG-EMG coherence (0-1) measure: Timed 25 feet walk test (T25FWT) measure: 6-minute walk test (6MWT) measure: Six spot step test (SSST) measure: 5 sit-to-stand (5STS) measure: 9-step stair ascend (9SSA) measure: Patient determined disease steps (PDDS) measure: Multiple Sclerosis Walking Scale (MSWS) measure: Modified fatigue impact scale (MFIS) measure: MS impact scale (MSIS) measure: Falls-efficacy scale - international (FES-1) measure: The Physical Activity Enjoyment Scale (PACES) measure: Brief pain inventory (BPI) measure: Baecke physical activity measure: Accelerometry sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06374095 id: ONSET briefTitle: 1 vs 7 RATG Infusions in Renal Transplantation acronym: ONSET overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2025-06 date: 2025-06 date: 2024-04-18 date: 2024-04-18 name: Mario Negri Institute for Pharmacological Research class: OTHER briefSummary: This trial is to compare the risk/benefit profile over six-month follow-up of two induction immunosuppressive regimens based on one or seven low-dose perioperative RATG infusions on top of the same induction therapy with basiliximab and steroid (progressively tapered post-transplant) and maintenance therapy with calcineurin inhibitors and mycophenolate mofetil/mycophenolic acid in 75 recipients (25 Patients and 50 Reference-Patients) of a single or dual first kidney transplant from an ideal or marginal donor at a single Renal Transplant Center. conditions: Kidney Replacement studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 75 type: ESTIMATED name: RATG name: Basiliximab measure: Incidence of thrombocytopenia and/or leukopenia measure: Occurrence of anemia measure: Occurrence of viral infections measure: Occurrence of pneumonia measure: Occurrence of opportunistic infections measure: Occurrence of delayed graft function measure: Occurrence of allograft rejection measure: Occurrence of biopsy proven rejection measure: Survival measure: Platelet and WBC counts measure: Creatinine levels measure: Adverse events sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: ASST HPG23 - Unità di Nefrologia city: Bergamo state: BG zip: 24127 country: Italy lat: 45.69601 lon: 9.66721 hasResults: False |
<|newrecord|> nctId: NCT06374082 id: HKWC-2024-179 briefTitle: Instant Messaging Reinforcement for Smoking Cessation Counseling Training overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-08 date: 2024-10 date: 2024-04-18 date: 2024-04-18 name: The University of Hong Kong class: OTHER briefSummary: This research aims to assess the impact of instant messaging reinforcement on the learning outcomes of smoking cessation counseling (SCC) training among master of nursing (MN) students at the University of Hong Kong. The hypotheses suggest that this reinforcement can enhance students' SCC knowledge and techniques, improve their perception of SCC, and increase their application of SCC in clinical work. |
The study is a pragmatic randomized controlled trial (RCT) with a 1:1 allocation ratio, using WhatsApp Messenger (WhatsApp) messages for intervention and control groups. The intervention group receives messages related to SCC, while the control group receives generic mental health information. The subjects are MN students enrolled in the "Tobacco Dependency Nursing Intervention and Management" course. |
The study uses various tools for measurement, including Ecological momentary assessment (EMA) and Providers Smoking Cessation Training Evaluation (ProSCiTE). The main outcome measures include SCC practice frequency, SCC knowledge score, SCC attitude score, and SCC practice score. |
Data analysis will be performed in Statistical Package for the Social Sciences (SPSS), using descriptive statistics, intention-to-treat analysis, Chi-square and t-tests, Cohen's d for effect size, and linear mixed models. The expected results suggest that instant messaging reinforcement will enhance SCC knowledge, attitude, and practice among MN students. conditions: Smoking Cessation Counseling Ability conditions: Smoking Cessation Counseling Practice studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: DOUBLE maskingDescription: Double-blinding technique will be used to conceal the allocation. Participants will not know which group they are in as placebo messages will be introduced. Using a central allocation web-based-controlled randomization, outcome assessors and data analysts will be blind to group allocation, only the principal investigator will be aware of who belongs to the control and intervention groups. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: WhatsApp message measure: SCC practice measurement measure: SCC knowledge score measure: SCC attitude score measure: SCC practice score sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Hong KongLKS Faculty of Medicine city: Hong Kong zip: 00 country: Hong Kong name: Derek Yee Tak Cheung, PhD role: CONTACT phone: +852 3917 6652 email: [email protected] name: Derek Yee Tak Cheung, PhD role: PRINCIPAL_INVESTIGATOR name: Xiaoyun Xie, PhDcandidate role: SUB_INVESTIGATOR name: Guowen Zhang, DN student role: SUB_INVESTIGATOR name: Tzu Tsun Luk, PhD role: SUB_INVESTIGATOR name: Man Ping Wang, PhD role: SUB_INVESTIGATOR name: Siu Chee Chan, PhD role: SUB_INVESTIGATOR lat: 22.27832 lon: 114.17469 hasResults: False |
<|newrecord|> nctId: NCT06374069 id: NL81887.058.23 briefTitle: Longevity Families of the Netherlands acronym: LOF-NL overallStatus: RECRUITING date: 2023-09-11 date: 2026-12 date: 2026-12 date: 2024-04-18 date: 2024-04-18 name: Leiden University Medical Center class: OTHER name: Jacobijn Gussekloo, Prof. dr. name: Simon P. Mooijaart, Prof. dr. briefSummary: The demographic life expectancy enhancement of the past 150 years imposes an urgent challenge in Western and economically growing societies to stimulate the healthy lifespan that is lagging behind. Families surviving into exceptionally high ages (longevity) in good physical and mental health illustrate that this is physiologically possible. Such families harbor cross generational socio-genetic mechanisms that mediate healthy aging and protection from (multi)morbidity. |
The purpose of our research is: to identify gene variants associated with healthy aging and protection from (multi)morbidity; to study the social-, environment- and behavioral factors of familial longevity, their role in (multi-)morbidity and its interaction with the genetic component. conditions: Longevity conditions: Familial Longevity conditions: Extreme Longevity conditions: Aging studyType: OBSERVATIONAL observationalModel: FAMILY_BASED timePerspective: CROSS_SECTIONAL count: 600 type: ESTIMATED measure: Identifying the genetic variants of Familial Longevity measure: Studying the environmental factor of Familial Longevity through questionnaires and its interaction with the genetic component sex: ALL minimumAge: 75 Years stdAges: OLDER_ADULT facility: Leiden University Medical Center status: RECRUITING city: Leiden state: South Holland zip: 2333ZA country: Netherlands lat: 52.15833 lon: 4.49306 hasResults: False |
<|newrecord|> nctId: NCT06374056 id: 0458 briefTitle: Kintsugi Voice Device Pilot Study overallStatus: RECRUITING date: 2024-03-22 date: 2025-03-22 date: 2025-07-22 date: 2024-04-18 date: 2024-04-19 name: Kintsugi Mindful Wellness, Inc. class: INDUSTRY name: Sonar Strategies name: Vituity Psychiatry briefSummary: A prospective, single arm, non-randomized, pilot clinical validation study to evaluate the ability of the Kintsugi Voice Device (the Device) to aid clinical assessment for depression by comparing its output with a diagnosis made by a clinician using the Structured Clinical Interview for DSM-5 (SCID-5-CT) for up to 500 English speaking adult patients ages 22 and older living in the United States. Recruitment will occur for 1 year and participation will be for up to 2 weeks. conditions: Depression conditions: Depression Moderate conditions: Depression Severe conditions: Depression Mild studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 500 type: ESTIMATED name: Kintsugi Voice Device measure: Sensitivity and Specificity of Kintsugi Voice Device Relative to the SCID-5 measure: PPV, NPV, AUC, F-Score of Kintsugi Voice Device Relative to the SCID-5 measure: Sensitivity, Specificity, PPV, NPV, AUC, F-Score of Kintsugi Voice Device Relative to the Severity of the SCID-5-CT measure: Sensitivity, Specificity, PPV, NPV, AUC, F-Score of Kintsugi Voice Device Relative to the PHQ-9 sex: ALL minimumAge: 22 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Kintsugi Mindful Wellness Inc. status: RECRUITING city: Berkeley state: California zip: 94707 country: United States name: Alexa A Mazur, BA role: CONTACT phone: 610-724-1431 email: [email protected] name: Victoria Graham, MS role: CONTACT email: [email protected] name: Albert Ihochi, MBA role: PRINCIPAL_INVESTIGATOR name: Prentice Tom, MD role: SUB_INVESTIGATOR lat: 37.87159 lon: -122.27275 hasResults: False |
<|newrecord|> nctId: NCT06374043 id: 2020/1002 briefTitle: Decentralized N=1 Study: A Feasible Approach to Evaluate Individual Therapy Response to Dapagliflozin. acronym: @HOME overallStatus: COMPLETED date: 2021-05-11 date: 2022-09-13 date: 2022-09-13 date: 2024-04-18 date: 2024-04-22 name: University Medical Center Groningen class: OTHER name: AstraZeneca briefSummary: Randomized placebo-controlled double-blind cross-over N=1 trial in adult male and female patients with UACR \>20 mg/g (2.26 mg/mmol) with type 2 diabetes treated in primary or secondary healthcare. |
The goal of this clinical trial is to determine the individual response to the SGLT2 inhibitor dapagliflozin in urine albumin-to-creatinine ratio (UACR). Secondary objectives are to determine the individual response to dapagliflozin in systolic blood pressure, body weight, eGFR, and fasting plasma glucose. |
Participants will collect all study data in the comfort of their own environments: |
* First-morning void urine samples |
* Capillary blood samples |
* Blood pressure |
* Body weight |
Participants will be randomly assigned to a cross-over study consisting of two periods of 1-week treatment with dapagliflozin 10 mg/day and two periods of 1-week treatment with placebo in random order with a 1-week wash-out period between every treatment period to avoid cross-over effects. conditions: Diabetes Mellitus, Type 2 conditions: Diabetes Mellitus Type 2 With Proteinuria conditions: Diabetes Mellitus conditions: Diabetes conditions: Diabetes Complications conditions: Albuminuria conditions: Chronic Kidney Diseases conditions: Chronic Kidney Disease Due to Type 2 Diabetes Mellitus conditions: CKD conditions: Proteinuria studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Randomized placebo-controlled double-blind cross-over trial with repeated administration (i.e., a series of N=1 trials). primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 20 type: ACTUAL name: Dapagliflozin 10mg Tab name: Placebo name: Withings BPM Connect name: Withings Body+ name: Hem-Col Capillary Blood Collection Device name: MEMS (Medication Electronic Monitoring System) Cap name: Questionnaire: participants' perspectives toward remote data collection measure: UACR response measure: Systolic blood pressure response measure: Body weight response measure: eGFR response measure: Fasting plasma glucose response sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ziekenhuisgroep Twente city: Almelo country: Netherlands lat: 52.35667 lon: 6.6625 facility: University Medical Center Groningen city: Groningen country: Netherlands lat: 53.21917 lon: 6.56667 hasResults: False |
<|newrecord|> nctId: NCT06374030 id: EDSAM2024 briefTitle: Retrospective Study of Airway Management in Dutch ED's overallStatus: ACTIVE_NOT_RECRUITING date: 2019-01-01 date: 2023-12-31 date: 2024-12-31 date: 2024-04-18 date: 2024-04-18 name: Medical Centre Leeuwarden class: OTHER name: VieCuri Medical Centre name: Catharina Ziekenhuis Eindhoven name: Rijnstate Hospital name: Zuyderland Medical Centre briefSummary: Describing characteristics of the practice of airway management in Dutch emergency departments, including information about patient demographics, indications, performer characteristics, equipment and medication used and complications due to intubation. conditions: Endotracheal Intubation studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 1000 type: ESTIMATED name: Endotracheal intubation measure: Different complications of endotracheal intubation measure: Intubator characteristics measure: Indication for intubation measure: Sedation agent used measure: Paralytic agent used measure: Sedative agent after intubation measure: Method of intubation measure: Patient characteristics sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Leeuwarden Medical Centre city: Leeuwarden zip: 8934AD country: Netherlands lat: 53.20139 lon: 5.80859 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2023-12-15 uploadDate: 2024-03-20T05:01 filename: Prot_SAP_000.pdf size: 247439 hasResults: False |
<|newrecord|> nctId: NCT06374017 id: N-258-2023 briefTitle: Evaluation of Lidocaine Spray Versus Dexmetomidine Spray on Stress Response overallStatus: RECRUITING date: 2023-09-20 date: 2024-04-30 date: 2024-05-10 date: 2024-04-18 date: 2024-04-18 name: Kasr El Aini Hospital class: OTHER briefSummary: Many studies discussed attenuating stress response by various measures but to the interest of our study , No one compared topical spray of both lidocaine and dexmedetomidine in attenuating the haemodynamic stress responses of laryngoscopy and endotracheal intubation, avoiding undesired systemic effects of drugs , conditions: To Measure Systolic Blood Pressure Postintubation studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: SINGLE whoMasked: INVESTIGATOR count: 120 type: ESTIMATED name: Normal saline, Lidocaine, dexmetomidine measure: To measure systolic blood pressure immediately after intubation. sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Cairo University hospitals status: RECRUITING city: Cairo zip: 11559 country: Egypt name: Dina M Mohamed, MD role: CONTACT phone: 01005249134 phoneExt: MD email: [email protected] lat: 30.06263 lon: 31.24967 hasResults: False |
<|newrecord|> nctId: NCT06374004 id: HU-FTR-MC-01 briefTitle: The Effect of Thoracic Mobilization in Individuals With Subacromial Pain Syndrome overallStatus: ENROLLING_BY_INVITATION date: 2024-04-10 date: 2024-07-05 date: 2024-07-05 date: 2024-04-18 date: 2024-04-18 name: Hacettepe University class: OTHER briefSummary: The purpose of this study is to investigate the effect of six-week thoracic mobilization on pain intensity, muscle tone, functional and muscle activation in individuals with subacromial pain syndrome. conditions: Subacromial Pain Syndrome studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: One group received exercise therapy and the other group received manual therapy (thoracic mobilization) in addition to exercise therapy primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Participants will be randomly divided into two groups and participants will not know which group participants are in. whoMasked: PARTICIPANT count: 32 type: ESTIMATED name: Exercise Group name: Thoracic Mobilization Group measure: Electromyography (EMG) measure: Acromiohumeral Distance (AHD) measure: Muscle Tone measure: Functional Activity Level measure: Pain Intensity sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Hacettepe University, Faculty of Physical Therapy and Rehabilitation city: Ankara zip: 06100 country: Turkey lat: 39.91987 lon: 32.85427 hasResults: False |
<|newrecord|> nctId: NCT06373991 id: EDI-901-SLE01 briefTitle: A Study to Evaluate the Safety and Efficacy of ATHENA CAR-T in Subjects With Systemic Lupus Erythematosus overallStatus: RECRUITING date: 2024-04-24 date: 2027-04-30 date: 2027-04-30 date: 2024-04-18 date: 2024-04-29 name: EdiGene Inc. class: INDUSTRY name: The First Affiliated Hospital of Henan University of Science and Technology name: Changping Laboratory briefSummary: The goal of this clinical trial is to test ATHENA CAR-T injection in adults with moderate to severe Systemic Lupus Erythematosus. The main question it aims to answer is: |
• To evaluate the safety and tolerability of ATHENA CAR-T. |
After screening, participants will be subjected to lymphodepletion regimen. After recovery, participants will be injected with ATHENA CAR-T injection and followed up to 24 months. conditions: Lupus Erythematosus, Systemic studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 12 type: ESTIMATED name: ATHENA CAR-T name: Fludarabine name: Cyclophosphamide measure: Dose Limiting Toxicity measure: Frequency of AEs, SAEs, lab abnormalities, AESIs measure: Efficacy: Percent of patients achieved SRI-4 measure: Efficacy: Patients SLEDAI-2000 change compared with baseline measure: Efficacy: Patients BILAG-2004 change compared with baseline measure: Efficacy: Percent of patients' PGA not worsen measure: Percent of patients responded by BILAG-2004 measure: Efficacy: Immunologic parameters measure: Efficacy: Immunologic parameters (cont) measure: PK characteristics measure: PK characteristics (cont) measure: PK characteristics (cont) measure: PD characteristics measure: PD characteristics (cont) sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The First Affiliated Hospital of Henan University of Science and Technology status: RECRUITING city: Luoyang state: Henan zip: 471003 country: China name: Muchen Liu role: CONTACT phone: (86)-13663884080 lat: 34.68361 lon: 112.45361 hasResults: False |
<|newrecord|> nctId: NCT06373978 id: 24-307 briefTitle: NonNarcotic Pain Control in Percutaneous Needle Tenotomy of Elbow overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-06-01 date: 2025-12-01 date: 2024-04-18 date: 2024-04-18 name: The Cleveland Clinic class: OTHER briefSummary: This study is a double-blind, randomized controlled trial comparing the effectiveness of oral Diclofenac and Tramadol in reducing the consumption of narcotic pills (primary outcome) and minimizing patients\' exposure to narcotics (secondary outcome) following an ultrasound-guided percutaneous needle tenotomy procedure on the lateral elbow. |
The primary objective of this study is to illustrate a reduction in the consumption of narcotic pills following a percutaneous needle tenotomy procedure on the lateral elbow. |
The secondary aim is to assess the proportion of patients who have been randomly assigned to Diclofenac and successfully refrain from using the Tramadol rescue medication, measured at the 10 day (+/- 4 days) postoperative mark. |
The third objective is to uphold consistent early recovery outcomes as measured by the Patient-Rated Tennis Elbow Evaluation (PRTEE) and Quick Disability of Arm, Shoulder, and Hand (QuickDASH) scores after percutaneous needle tenotomy of the lateral elbow, while also investigating the relationship between resiliency and pain catastrophizing in relation to Tramadol usage and response to Diclofenac. conditions: Elbow Pain conditions: Chronic Pain studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This study will be a double-blind, randomized trial comparing a control group receiving the standard care narcotic Tramadol (50mg) to an experimental group receiving Diclofenac (50mg). primaryPurpose: SUPPORTIVE_CARE masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 92 type: ESTIMATED name: Diclofenac name: Tramadol measure: Number of pills taken measure: Non narcotic use sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Cleveland Clinic Florida city: Coral Springs state: Florida zip: 33067 country: United States name: Jennifer Baldwin role: CONTACT phone: 216-390-5833 email: [email protected] name: Alison Klika role: CONTACT phone: 216 444-4954 email: [email protected] name: Michael Dakkak, DO role: PRINCIPAL_INVESTIGATOR lat: 26.27119 lon: -80.2706 facility: The Cleveland Clinic Ohio city: Avon state: Ohio zip: 44011 country: United States name: Jennifer Baldwin role: CONTACT phone: 216-390-5833 email: [email protected] name: Jason Genin, DO role: SUB_INVESTIGATOR name: Vikas Patel, DO role: SUB_INVESTIGATOR lat: 41.45171 lon: -82.03542 hasResults: False |
<|newrecord|> nctId: NCT06373965 id: B2024-000 briefTitle: Integrated Online-to-offline (O2O) Model of Care for HIV Prevention and Treatment Among Transgender Women (CINTAI) overallStatus: NOT_YET_RECRUITING date: 2024-05-19 date: 2025-01-06 date: 2025-02-18 date: 2024-04-18 date: 2024-04-18 name: University of Connecticut class: OTHER name: University of Malaya briefSummary: The proposed research focuses on developing and testing a web-based platform, called Jom-TestPlus, that will incorporate HIV self-testing (HIVST) with real-time e-counseling (eHIVST) with online-to-offline (O2O) linkage to HIV prevention and treatment services while simultaneously co-addressing chemsex-related needs for transgender women (TGW) in Malaysia. This model represents a potentially impactful strategy for reaching marginalized populations, like TGW, and allows immediate engagement in the post-test linkage process to prevention or treatment services. conditions: HIV Prevention Program studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 50 type: ESTIMATED name: Online to offline counseling measure: HIVST uptake measure: Linkage to PrEP measure: Linkage to HIV treatment services sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Centre of Excellence For Research in AIDS (CERiA) city: Kuala Lumpur country: Malaysia lat: 3.1412 lon: 101.68653 hasResults: False |
<|newrecord|> nctId: NCT06373952 id: 23-08-658-910 briefTitle: Integrated Online-to-offline (O2O) Model of Care for HIV Prevention and Treatment Among Men Who Have Sex With Men acronym: CINTAI overallStatus: NOT_YET_RECRUITING date: 2024-05-19 date: 2025-01-06 date: 2025-02-18 date: 2024-04-18 date: 2024-04-22 name: University of Connecticut class: OTHER name: University of Malaya briefSummary: The proposed research focuses on developing and testing a web-based platform, called Jom-TestPlus, that will incorporate HIV self-testing (HIVST) with real-time e-counseling (eHIVST) with online-to-offline (O2O) linkage to HIV prevention and treatment services while simultaneously co-addressing chemsex-related needs for men who have sex with men (MSM) in Malaysia. This model represents a potentially impactful strategy for reaching marginalized populations, like MSM, and allows immediate engagement in the post-test linkage process to prevention or treatment services. conditions: HIV Prevention Program studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 78 type: ESTIMATED name: Online to offline counseling measure: HIVST uptake measure: Linkage to PrEP measure: Linkage to HIV treatment services sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Centre of Excellence For Research in AIDS (CERiA) city: Kuala Lumpur country: Malaysia lat: 3.1412 lon: 101.68653 hasResults: False |
<|newrecord|> nctId: NCT06373939 id: Pneumoscope study briefTitle: Performance and Safety of the Pneumoscope Device in Adults and Children overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2024-12-31 date: 2024-12-31 date: 2024-04-18 date: 2024-04-18 name: Pediatric Clinical Research Platform class: OTHER name: University Hospital, Geneva briefSummary: Respiratory diseases are associated with high morbidity and mortality worldwide. Proper diagnosis and risk assessment of these conditions are essential for optimal management. Clinicians use three particularly useful tools to identify these conditions when assessing the patient's status: the stethoscope, the pulse oximeter, and the thermometer. The Pneumoscope is an all-in-one device including a digital stethoscope, a pulse oximeter, and a thermometer. This study aims to assess the performance and safety of the Pneumoscope in recording respiratory sounds, body temperature, non-invasive blood oxygen saturation levels and heart rate in children and adults. conditions: Respiratory Diseases conditions: Pneumonia conditions: Asthma conditions: Cyanotic Heart Disease studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: This single center, open, non-controlled investigation will be conducted at one site; the University Hospitals of Geneva, Switzerland. This will be a non-inferiority study between Pneumoscope and CE marked comparable medical devices in children and adults. primaryPurpose: OTHER masking: NONE count: 225 type: ESTIMATED name: Digital lung auscultation name: Pulse oximetry measurement name: Non invasive body temperature measurement measure: Evaluation of Pneumoscope's built-in sensors measure: Collect audio records of lung sounds for AI models training and sensor calibration measure: Pulse oximetry measure: Body temperature sex: ALL minimumAge: 1 Year stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Geneva University Hospitals city: Geneva zip: 1205 country: Switzerland name: Alain Gervaix, Prof role: CONTACT phone: (0)22 372 45 55 phoneExt: +41 email: [email protected] name: Johan Siebert, MD role: CONTACT phone: (0)79 553 40 72 phoneExt: +41 email: [email protected] name: Johan N Siebert, MD role: PRINCIPAL_INVESTIGATOR name: Laurence Lacroix-Duccardonnoy, MD role: SUB_INVESTIGATOR name: Isabelle Ruchonnet-Métrailler, MD role: SUB_INVESTIGATOR lat: 46.20222 lon: 6.14569 hasResults: False |
<|newrecord|> nctId: NCT06373926 id: PI2019_843_0010 briefTitle: Evaluation of Cell Membrane Expression of Annexin A2 on Monocytes by Flow Cytometry in Primary Antiphospholipid Syndrome acronym: MONOCYTAN overallStatus: RECRUITING date: 2023-03-28 date: 2025-03 date: 2025-03 date: 2024-04-18 date: 2024-04-18 name: Centre Hospitalier Universitaire, Amiens class: OTHER briefSummary: Annexin A2 (ANXA2), an endothelial cell receptor for plasminogen and tissue plasminogen activator, plays a pivotal role in regulation of fibrinolysis in vitro and in vivo and has been identified as a new autoantigen in antiphospholipid syndrome (APS). ANXA2 can exist as a monomer or a heterotetrameric complex with S100A10 protein. The aim of this study was to evaluate the cell membrane expression of ANXA2 on circulating monocytes in APS by flow cytometry. Several pathogenic mechanisms are involved in APS such as activation of endothelial cells, platelets and monocytes, inhibition of the natural anticoagulant protein C/protein S pathway, activation of the complement system and also impairment of fibrinolysis. Annexin A2 which hits binding partner S100A10, ANXA2 forms a cell surface complex that regulates generation of plasmin. ANXA2 is involved in the pathogenesis of APS-associated through several possible mechanisms. Human peripheral blood monocytes represent the major circulating ANXA2-expressing cell and ANXA2-mediated assembly of plasminogen and tissue activator of plasminogen (tPA) on monocyte/macrophages contributes to plasmin generation. Thus the investigators could suppose that decrease of cell membrane expression of ANXA2 on circulating monocytes represent a new pathogenic mechanism in APS. conditions: Antiphospholipid Syndrome studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: NONE count: 60 type: ESTIMATED name: blood withdrawal measure: Cell membrane expression rate of ANXA2 on circulating monocytes in APS measure: Cellular expression of ANXA2 and S100A10 in APS patients measure: cell membrane expression of ANXA2 and S100A10 in APS patients sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHU Amiens status: RECRUITING city: Amiens zip: 80054 country: France name: Valéry SALLE, MD role: CONTACT phone: +33 3 22 66 82 30 email: [email protected] lat: 49.9 lon: 2.3 hasResults: False |
<|newrecord|> nctId: NCT06373913 id: MASP2NSRZL briefTitle: The Role of Proprotein-convertase-subtilisin/Kexin-type 9 in Kidney Damage in Nephrotic Syndrom acronym: PCSK9 overallStatus: RECRUITING date: 2023-06-01 date: 2027-07-30 date: 2028-07-30 date: 2024-04-18 date: 2024-04-18 name: Kolding Sygehus class: OTHER name: Odense University Hospital name: Vejle Hospital briefSummary: Nephrotic syndrome (NS) is characterized by gross proteinuria (\>3.5 g/day), hypoalbuminaemia, edema and often hyperlipidemia. Hyperlipidemia is correlated with increased morbidity and mortality. |
The study aim is to investigate the role of the protein convertase subtilisin/kexin type 9 (PCSK9) in hyperlipidemia of NS, which has been suggested to play an important role. This is done by testing the following hypotheses: |
1. PCSK9 is increased in patients with NS and hyperlipidemia compared to kidney-healthy controls |
2. The level of PCSK9 in plasma correlates to the degree of proteinuria. |
3. PCSK9 i increased in the kidney tissue of patients with NS |
The study will compare plasma levels of PCSK9 in correlation with degree of protein in the urine between test persons with NS and kidney healthy controls. Furthermore the investigators will study the the degree of PCSK9 in the kidney in biopsies obtained from test persons with nephrotic syndrome and test persons without proteinuria. conditions: Hyperlipidemias conditions: Nephrotic Syndrome studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 75 type: ESTIMATED measure: Plasma PCSK9 correlated to the degree of protein in the urine measure: Degree of PCSK9 in kidney tissue measure: Localization of PCSK9 in kidney tissue sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Kolding Sygehus, Lillebælt Hospital status: RECRUITING city: Kolding zip: 6000 country: Denmark name: Rikke Z Langkilde, md, phd role: CONTACT phone: 004576362554 name: Anne D Thuesen, md, phd role: CONTACT phone: 004576360555 email: [email protected] lat: 55.4904 lon: 9.47216 hasResults: False |
<|newrecord|> nctId: NCT06373900 id: IndusH briefTitle: Wound Closure After Total Knee Arthroplasty: Comparison of Polypropylene and Polyglactin 910 Suture. overallStatus: COMPLETED date: 2022-02-13 date: 2022-02-19 date: 2022-03-30 date: 2024-04-18 date: 2024-04-18 name: Indus Hospital and Health Network class: OTHER briefSummary: Comparison of wound complication and scar formation in patient undergone bilateral total knee replacement comparison between polypropylene and polyglactin 910 suture. patient randomised according to SNOS protocol into group A and B for their right and left knee closure with each suture. patient followed on 3rd, 7th, 15th and 30th post operative day for wound healing, wound dehiscence and scar formation. conditions: Wound Heal conditions: Wound Dehiscence conditions: Wound Complication studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: SINGLE maskingDescription: SNOS protocol whoMasked: PARTICIPANT count: 40 type: ACTUAL name: wound closure measure: Wound characteristics and complications measure: Wound Infection Grade measure: Hollander Cosmetic Wound Evaluation Score sex: ALL minimumAge: 50 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Indus Hospital and Health Network city: Karachi state: Sindh zip: 74900 country: Pakistan lat: 24.8608 lon: 67.0104 typeAbbrev: Prot_SAP_ICF hasProtocol: True hasSap: True hasIcf: True label: Study Protocol, Statistical Analysis Plan, and Informed Consent Form date: 2022-02-04 uploadDate: 2024-04-03T02:55 filename: Prot_SAP_ICF_000.pdf size: 130365 hasResults: False |
<|newrecord|> nctId: NCT06373887 id: 2023-09-005A briefTitle: The Efficacy of Weight-loss Diet Decision-making Based on Initial Gut Metabolic Modules (GMMs) overallStatus: RECRUITING date: 2024-04-10 date: 2024-11-29 date: 2024-12-31 date: 2024-04-18 date: 2024-04-18 name: Taipei Veterans General Hospital, Taiwan class: OTHER_GOV briefSummary: In recent years, the technology to detect the gut microbiome's function has become increasingly developed. GMMs are tools (GitHub - raeslab/GMMs: A manually curated database of human gut metabolic modules.) for describing metabolic pathways for linking microbial metabolic function to species associated with a single metabolite, helping to analyze the transcriptional characteristics and metabolic functions of each bacterium, and studying their role of the food chain in the ecosystem. According to our previous research, the group with good weight loss response (more than 10% body weight loss in 8 weeks) after low-carb diet intervention has higher Shannon's diversity and carbohydrate degradation activity test by GMMs, implying the deficiency of availability of energy sources may cause more weight changes. |
Based on the above research, we designed a low-carb diet (rich in monounsaturated fatty acids) and a low-fat diet (whole grains) with the same calories as a means of weight loss. The primary purpose of this study is to evaluate the pre-GMM test for determines the weight loss benefit of the intervention diet. Furthermore, we try to found the possible mechanism of whether metabolites of microbiota (e.g. SCFA) could affect the immune cell change which modulates adipose tissue . conditions: Weight Loss studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: To compare the weight-loss efficacy of different carbohydrate degradation status under two different diet arm (low carbohydrate or low fat diet) to evaluate the benefits of initial gut microbiota profiling in precision weight loss dietary interventions. primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE maskingDescription: Single-blinded count: 150 type: ESTIMATED name: plant-based Low carbohydrate diet name: plant-based Low low fat diet measure: Body weight loss/fat mass loss measure: microbiota change sex: ALL minimumAge: 20 Years maximumAge: 64 Years stdAges: ADULT facility: Taipei Veterans General Hospital status: RECRUITING city: Taipei state: Beitou District zip: 11217 country: Taiwan name: Chun-Ying Wu role: CONTACT phone: +886-28712121 phoneExt: 4190 email: [email protected] name: HSIAO-PING CHEN role: CONTACT phone: +886-28712121 phoneExt: 4190 email: [email protected] lat: 25.04776 lon: 121.53185 hasResults: False |
<|newrecord|> nctId: NCT06373874 id: MCBU-SBF-YC-04 briefTitle: The Effect of High Reality Simulation Environment on the Skills of Midwifery Students, in Newborn Heel Blood Collection overallStatus: COMPLETED date: 2023-04-01 date: 2023-05-30 date: 2023-05-30 date: 2024-04-18 date: 2024-04-18 name: Celal Bayar University class: OTHER briefSummary: The researchers gave midwifery students theoretical training on how to take heel blood on a newborn model. Students were asked to take heel blood on the model in the high-reality simulation environment and simulation room. The student's ability to take heel blood before and after taking heel blood in a high-reality simulation environment or on a newborn model in a simulation environment, satisfaction with learning, anxiety and self-efficacy levels were compared. conditions: Students conditions: Educational Problems conditions: Anxiety studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Parallel Assignment experimental study with experimental and control group primaryPurpose: OTHER masking: NONE count: 92 type: ACTUAL name: Heel blood collection in a newborn simulation model measure: Skill checklist measure: State and Trait Anxiety Scales measure: Self-Efficacy Scale measure: Student Satisfaction and Self-Confidence in Learning Questionnaire sex: FEMALE minimumAge: 21 Years maximumAge: 32 Years stdAges: ADULT facility: Manisa Celal Bayar University Faculty of Health Sciences, Department of Midwifery city: Manisa zip: 45140 country: Turkey lat: 38.61202 lon: 27.42647 facility: Yonca çiçek okuyan city: Manisa zip: 45140 country: Turkey lat: 38.61202 lon: 27.42647 hasResults: False |
<|newrecord|> nctId: NCT06373861 id: 20-0482 briefTitle: Generating Advancements Through Longitudinal Analysis in X and Y Variations (GALAXY) acronym: GALAXY overallStatus: RECRUITING date: 2022-04-28 date: 2037-04 date: 2037-04 date: 2024-04-18 date: 2024-04-18 name: University of Colorado, Denver class: OTHER name: Children's Hospital Colorado briefSummary: GALAXY is a registry research study that plans to learn more about individuals with X\&Y variations (also called sex chromosome aneuploidies) through collecting information from medical records.This includes genetic tests, imaging, medications, and more for hundreds of patients seen at a number of clinics across the US. The purpose of the GALAXY Registry is to collect and store this information with the overall goal to improve health outcomes in individuals with X\&Y variations and the care they receive. conditions: Sex Chromosome Aneuploidy studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 5000 type: ESTIMATED name: no intervention measure: Health Conditions measure: Prevalence of mental health diagnoses measure: Cardiometabolic diagnoses - prevalence of obesity measure: Cardiometabolic diagnoses - prevalence of dyslipidemia measure: Cardiometabolic diagnoses-prevalence of hypertension measure: Autoimmune diagnoses - prevalence of hypothyroidism and of hyperthyroidism measure: Autoimmune diagnoses - prevalence of diabetes sex: ALL minimumAge: 0 Days maximumAge: 100 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Children's Hospital Colorado status: RECRUITING city: Aurora state: Colorado zip: 80045 country: United States name: Shanlee M Davis, MD, PhD role: CONTACT phone: 720-777-6073 email: [email protected] lat: 39.72943 lon: -104.83192 hasResults: False |
<|newrecord|> nctId: NCT06373848 id: 346 briefTitle: Comparison of Salivary Parameters in Patients Receiving CoQ10 and Vitamin E Supplementation overallStatus: ENROLLING_BY_INVITATION date: 2024-04-20 date: 2024-08-20 date: 2024-09-15 date: 2024-04-18 date: 2024-04-18 name: Islamic Azad University, Tehran class: OTHER briefSummary: Comparison of salivary markers in patients with Initial chronic periodontitis after non-surgical periodontal treatment with CoQ10 supplementation with vitamin E conditions: Periodontal Diseases studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Parallel Assignment, Randomized, Double-blind, Controlled design. primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: The study was carried out utilizing a double-blind approach. In order to guarantee objectivity, all three groups - the Vitamin E group, the Coq10 group, and the control group - received medications that were indistinguishable in terms of appearance, packaging, and color. Additionally, to minimize any potential bias, a clinician who had no association with the research labeled the medications as A, B, and C (empty) based on their content, and then distributed them among the patients. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 85 type: ESTIMATED name: Receive 30 mg of Coq10 measure: Total Antioxidant capacity (TAC) of saliva measure: Bleeding on probing sex: ALL minimumAge: 28 Years maximumAge: 35 Years stdAges: ADULT facility: Amirhossein Farahmand city: Tehran zip: 1947833113 country: Iran, Islamic Republic of lat: 35.69439 lon: 51.42151 hasResults: False |
<|newrecord|> nctId: NCT06373835 id: EMODEPSIDE_LAOS briefTitle: Efficacy and Safety of Emodepside in Adults Infected With Strongyloidiasis Stercoralis overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-07-31 date: 2024-07-31 date: 2024-04-18 date: 2024-04-18 name: Swiss Tropical & Public Health Institute class: OTHER name: National Institute of Public Health, Vientiane, Laos briefSummary: Efficacy, safety and pharmacokinetics of ascending dosages of emodepside and in comparison to ivermectin against Strongyloidiasis stercoralis in adults: randomized stage II seamless adaptive controlled trials conditions: Strongyloides Stercoralis Infection conditions: Strongyloidiasis studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 240 type: ESTIMATED name: Emodepside measure: Cure rate (CR) of emodepside against Strongyloides stercoralis measure: Safety and tolerability of the dose-dependent emodepside treatment regimes, and compared with ivermectin. measure: Geometric Mean Larvae Reduction Rate (LRR) of emodepside against Strongyloides stercoralis. measure: Exposure response of emodepside in adults measure: Cure rate (CR) and egg reduction rate (ERR) with other soil-transmitted helminths (STH) and trematodes sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT hasResults: False |
<|newrecord|> nctId: NCT06373822 id: 2024/18JAN/028 briefTitle: New Perspectives in Adenomyosis Pathogenesis With Epigenetic Analysis and miRNAs acronym: ADENO-MIRNA overallStatus: RECRUITING date: 2024-03-21 date: 2031-09 date: 2031-09 date: 2024-04-18 date: 2024-04-22 name: Université Catholique de Louvain class: OTHER briefSummary: Objectives: |
To identify differentially expressed miRNAs in the blood of adenomyosis patients in view to develop new diagnostic methods |
Hypotheses Circulating miRNAs may be abnormally expressed in patients suffering from adenomyosis and could be used to diagnose the disease |
Study Design Blood samples will be collected from healthy subjects and adenomyosis patients and miRNAs will be isolated and analyzed to detect potential differences. conditions: Adenomyosis studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 50 type: ESTIMATED name: Circulating-mirna measure: Circulating-miRNA as diagnostic biomarkers sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CUSL status: RECRUITING city: Brussel state: Woluwe-Saint-Lambert zip: 1200 country: Belgium name: Emilie Wacheul, MD role: CONTACT phone: 027645246 email: [email protected] lat: 50.85045 lon: 4.34878 hasResults: False |
<|newrecord|> nctId: NCT06373809 id: PDSC1970222 briefTitle: Placenta Derived Stem Cells for Treating of Chronic Ulcers and Neuropathy acronym: PDSC overallStatus: COMPLETED date: 2021-10-08 date: 2024-03-31 date: 2024-03-31 date: 2024-04-18 date: 2024-04-18 name: Michael H Carstens class: OTHER name: Ministerio de Salud de Nicaragua name: Wake Forest Institute for Regenerative Medicine briefSummary: This is an initial dose escalation safety and exploratory efficacy study to treat two groups of subjects with critically sized diabetic wounds and diabetic neuropathy using placental-derived stem cells (PDSC) transplanted by injection into soft tissues of the lower limb. Its primary objective is safety assessment and its secondary objective is determining optimum PDSC safe dose. Group 1 will receive implantation of cells in the ulcer, in the ulcer bed, and along the distal arterial vessels that supply blood to the foot. Group 2 will follow the same protocol for the foot but will have an additional dose of cells implanted in the anterior and posterior compartments of the same leg to determine the impact on peripheral neuropathy. Dose escalation and safety will be documented. Exploratory measures of efficacy include: ulcer healing, hemodynamic and anatomical effects on the arteries of the foot, and changes in the sensory perceptions of the foot. conditions: Diabetic Foot conditions: Diabetic Neuropathies conditions: Diabetic Foot Ulcer studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Prospective an open label primaryPurpose: TREATMENT masking: NONE count: 20 type: ACTUAL name: Transplantation of Placenta Derived Stem Cells measure: Foot Ulcer Healing measure: Fine Touch Sensation: Documenting diabetes-associated lower extremity pathophysiology changes. measure: Vibration: Documenting diabetes-associated lower extremity pathophysiology changes. sex: ALL minimumAge: 30 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital Escuela Oscar Danilo Rosales Arguello (HEODRA) city: León state: Leon zip: 21000 country: Nicaragua lat: 12.43787 lon: -86.87804 facility: Hospital Escuela Cesar Amador Molina city: Matagalpa zip: 61000 country: Nicaragua lat: 12.92559 lon: -85.91747 hasResults: False |
<|newrecord|> nctId: NCT06373796 id: 2024-A00523-44 briefTitle: Ultrasound Index Fat Fraction acronym: FAT-PLUS overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2024-07 date: 2024-09 date: 2024-04-18 date: 2024-04-18 name: SuperSonic Imagine class: INDUSTRY briefSummary: The objective is to compare the ultrasound index fat fraction (FAT PLUS), derived from several ultrasound biomarkers, with the gold-standard imaging exam for liver fat content evaluation (MRI-PDFF) in patients to quantify the hepatic steatosis. conditions: Steatosis of Liver studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 100 type: ESTIMATED name: Echographic scan measure: FAT PLUS sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06373783 id: 2023/05 briefTitle: Ultrasonographic Evaluation of the Connective Tissue Grafts Obtained With Two Different Methods in Root Coverage overallStatus: COMPLETED date: 2023-06-15 date: 2024-01-15 date: 2024-03-16 date: 2024-04-18 date: 2024-04-23 name: Pamukkale University class: OTHER briefSummary: Gingival recession is a clinical problem that increases with age and affects patient comfort. It is defined as the displacement of the gingival margin to a more apical position of the cementum-enamel border of the tooth. |
Coronally advanced flap (CAF) or tunnel technique (TUN) with subepithelial connective tissue procedures have been reported to be the most predictable methods of single gingival recession treatments. The ultimate goal of these plastic periodontal surgical procedures is to close the exposed root surface and achieve optimum aesthetic results. The main indications for root coverage (RC) procedures are aesthetic concern, root hypersensitivity, prevention of cervical abrasion and root caries, improvement of restorative results, and facilitation of plaque control. The use of a subepithelial connective tissue graft (SCGT) combined with a coronally positioned flap is considered the gold standard by many authors for single gingival recession treatments. |
De-epithelialization of free gingival grafts (DGG) has been proposed, especially when palatal tissue thickness is insufficient (≤2.5 mm) and larger graft size in the apico-coronal or mesio-distal directions is required. In this technique, the graft of the required width and length is separated from the lateral side of the palate, and then the 0.3-0.5 mm thick epithelial layer of the resulting graft is cut from the connective tissue layer. |
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