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* The efficacy of washing microbiota transplantation in the clinical treatment of diabetic gastrointestinal motility disorders patients and potential factors that may influence treatment outcomes.
* The potential mechanisms of washing microbiota transplantation in treating diabetic gastrointestinal motility disorders patients.
Participants will be collected fasting venous blood and random stool samples before treatment and at week 12 post-treatment, conducting scale assessments before treatment and at weeks 1, 4, and 12 post-treatment. conditions: Diabetic Gastroparesis conditions: Diabetic Gastropathy conditions: Diabetic Gastroenteropathy conditions: Diabetic Gastroparesis Associated With Type 2 Diabetes Mellitus studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: Washing Microbiota Transplantation measure: Gastrointestinal Symptom Rating Scale measure: Gut Microbiome Sequencing measure: Gastroparesis Cardinal Symptom Index measure: Composite Autonomic Symptom Score 31 measure: Gastrointestinal Motility measure: Heart Rate Variability measure: Serum Metabolites sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Second Affiliated Hospital of Nanjing Medical University city: Nanjing state: Jiangsu zip: 210000 country: China name: Dafa Ding, Professor role: CONTACT phone: +8615850514014 email: dingdafa@njmu.edu.cn lat: 32.06167 lon: 118.77778 hasResults: False
<\|newrecord\|> nctId: NCT06340815 id: VAR-2022-02 briefTitle: Varian ProBeam Proton Therapy System Clinical Trial (Shandong) overallStatus: COMPLETED date: 2022-07-20 date: 2023-03-08 date: 2023-03-10 date: 2024-04-02 date: 2024-04-02 name: Varian, a Siemens Healthineers Company class: INDUSTRY briefSummary: This study is prospective, single-center, single-arm objective performance criteria.
This trial will be conducted with a total of 47 subjects enrolled. All of subjects will be treated with radiation therapy using the medical device Varian ProBeam Proton Therapy System (ProBeam), aim to compare the data with objective performance criteria (OPC) to evaluate the effectiveness and safety of ProBeam radiotherapy system for oncology patients, providing a clinical basis for the medical device registration. conditions: Tumor, Solid studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: a clinical study of prospective, single-arm objective performance criteria primaryPurpose: TREATMENT masking: NONE count: 47 type: ACTUAL name: Radiation: Proton Therapy System (ProBeam) measure: Effectiveness evaluation: Local tumor control rate at 90 days after the proton radiation treatment completion measure: Safety evaluation: Incidence of Acute radiation injury measure: Safety evaluation: Incidence of Adverse Events based on CTCAE 5.0 criteria sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sophia Shao city: Shanghai zip: 230001 country: China lat: 31.22222 lon: 121.45806 hasResults: False
<\|newrecord\|> nctId: NCT06340802 id: SYG001 briefTitle: A First in hUman Study for Resistant Epilepsy With the Vagus Nerve stimulatiOn Device by syneRgia medicAl acronym: AURORA overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2025-03 date: 2026-12 date: 2024-04-02 date: 2024-04-02 name: Synergia Medical class: INDUSTRY briefSummary: This is an open label, single arm, interventional, prospective first in human study, designed to evaluate the safety of the NAO.VNS SYSTEM. conditions: Drug Resistant Epilepsy studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 10 type: ESTIMATED name: VNS Treatment measure: Treatment emergent adverse events measure: Procedure and/or device related adverse events measure: Device-related treatment emergent adverse events measure: Device deficiencies measure: Procedural Success measure: Change in seizure frequency measure: Proportion of responders measure: Change in seizure severity measure: Change in quality of life measure: Changed in mood measure: Usability measure: Exploratory Endpoints sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06340789 id: A-BR-110-49 briefTitle: Neurotransmitters in Treatment Resistant Schizophrenia Patients With add-on Sodium Benzoate overallStatus: NOT_YET_RECRUITING date: 2024-04-10 date: 2025-04-30 date: 2025-04-30 date: 2024-04-02 date: 2024-04-15 name: National Cheng-Kung University Hospital class: OTHER briefSummary: Although antipsychotic is effective for schizophrenia, however, still certain proportion of patients were not responsive to treatment. Treatment resistant schizophrenia (TRS) is accompanied by function decline and heavy burden. In recent decades, the biological mechanism of schizophrenia extended from dopamine theory to the role of glutamate system. This shift could be an alternative pathway to developing the treatment of TRS. Sodium benzoate (SB) could be an option as a glutamatergic agent for the patients with TRS. However, most evidence of SB is for treating patients with schizophrenia and other mental disorders but the evidence for treating patients with TRS is scarce. To predict the treatment response of SB will be an urgent topic in the future. Little is known about the precise medicine for treating patients with TRS. The present project will extend our pilot randomized clinical trial on SB for TRS. A total of 90 patients with TRS will be enrolled from three centers and will be assigned to 8 weeks of treatment with SB or placebo (2:1). A comprehensive battery of potential markers will be employed, including 1H- magnetic resonance spectroscopy (MRS), brain functional connectivity, genotyping, immune biomarkers, cognitive function, and clinical characteristics. The efficacy of SB on TRS will be confirmed in this project. Predictors for treatment response will be identified. Artificial intelligence algorithms will be used for probing the feasibility of precision medicine. conditions: Symptom, Cognitive conditions: Schizophrenia conditions: Schizo Affective Disorder studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The design and instrument are identical for two years. This add-on sodium benzoate randomized, double-blinded, placebo-controlled trial which is a two-arm, 6-week follow-up trial. The 90 patients will be 2:1 (SB: placebo) randomly assigned to 1. Treatment with sodium benzoate (A); or 2. placebo (P). The group of sodium benzoate treatment will be divided into two subgroups: 1. Responder (AR), and nonresponder (AN), as illustrated in Figure 4. The response criteria is defined the improvement of 20% total PANSS score after 6-week SB treatment. The participants with TRS will be enrolled in this trail from 3 hospitals(National Cheng Kung University Hospital, Tainan Hospital, Ministry of Health and Welfare, Chia-Yi branch, Taichung Veteran General Hospital). primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 90 type: ESTIMATED name: Sodium Benzoate 2gram/day name: Placebo measure: Brain imaging, functional MRI measure: Clinical psychiatric condition, Positive and Negative Symptoms Scale (PANSS) measure: Wechsler adult intelligence scales 4th edition (WAIS-IV) measure: Continuous performance test third edition (CPT-3) measure: Wisconsin card sorting test (WCST) sex: ALL minimumAge: 20 Years maximumAge: 55 Years stdAges: ADULT hasResults: False
<\|newrecord\|> nctId: NCT06340776 id: 81321 briefTitle: The Effects of Acupressure on Pain, and Gastrointestinal Functions in Women With Hysterectomy overallStatus: COMPLETED date: 2021-08-15 date: 2023-06-20 date: 2023-09-28 date: 2024-04-02 date: 2024-04-25 name: Istanbul Medipol University Hospital class: OTHER briefSummary: Aim This randomized controlled trial was conducted to evaluate the effect of acupressure application on gastrointestinal functions and pain after abdominal hysterectomy.
Materials and methods After undergoing hysterectomy, 39 women were randomised into acupressure (n=19), and control groups (n=20). Women in the acupressure group received acupressure on the mide meridian (ST36), the heart meridian (HT7), large intestine meridian (LI4), intersection of the spleen, liver and kidney meridians 6(SP6) and pericardium meridian (PC6) acupoints 30 min after admission to the clinic, for a period of 15 min, whereas those in the sham group received acupressure on locations 1-1.5 cm away from these points. The control group received standard treatment. The patient information form, Visual analog scale, the Rhodes Index of Nausea, Vomiting and Retching, and daily follow-up form were used for data collection. conditions: Pain Management conditions: Hysterectomy conditions: Vomiting studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Acupressure groupThose who received acupressure application were called the experimental group, and patients who received routine post-operative care were called the control group. Acupressure application was applied to the experimental group at the third and twenty-fourth hours after surgery.
Control group:The control group was evaluated for two days without any application. primaryPurpose: SUPPORTIVE_CARE masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 60 type: ACTUAL name: Acupressure measure: the score of nausea, vomiting and retching experiences measure: gas output and stool formation of the participants measure: postoperative pain measure: Systolic Blood pressure measure: Heart rate measure: Diastolic blood pressure sex: FEMALE minimumAge: 35 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Yeliz Yildirim Varişoğlu city: Istanbul state: Beykoz zip: 34413 country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False
<\|newrecord\|> nctId: NCT06340763 id: ABT-CIP-10466 id: CRD_1058 type: OTHER domain: Abbott briefTitle: JETi Hong Kong Post Market Study (PMS) overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-02 date: 2025-02 date: 2024-04-01 date: 2024-04-04 name: Abbott Medical Devices class: INDUSTRY briefSummary: The JETi Hong Kong PMS is a prospective, single-arm, multicenter study to collect real-world data on the safety, performance, and clinical benefits of the JETi System for the treatment of acute and subacute thrombosis in the lower extremity peripheral vasculature. This is a post-market study that will register approximately 20 subjects at approximately 5 centers in Hong Kong. Subjects participating in this study will be followed for up to 30 days after the JETi procedure. conditions: Peripheral Artery Thrombosis conditions: Peripheral Venous Thrombosis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 20 type: ESTIMATED name: JETi Hydrodynamic Thrombectomy System measure: For Arterial Subjects: Clot removal grade for each JETi-treated vessel measure: For Arterial Subjects: Composite of JETi-related major adverse events (MAEs) measure: For Venous Subjects: Percent of treated vessel(s) with ≥ 75% venous thrombus reduction via modified Marder score (limb basis). measure: For Venous Subjects: Composite of JETi-related major adverse events (MAEs) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Prince of Wales Hospital city: Hong Kong country: Hong Kong name: Guangming TAN, Prof. role: CONTACT phone: +852 3505 2211 name: Guangming TAN, Prof. role: PRINCIPAL_INVESTIGATOR lat: 22.27832 lon: 114.17469 hasResults: False
<\|newrecord\|> nctId: NCT06340750 id: LMY-920-003 briefTitle: BAFF CAR-T Cells (LMY-920) for Systemic Lupus Erythematosus overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2025-10-15 date: 2026-04-15 date: 2024-04-01 date: 2024-04-01 name: Luminary Therapeutics class: INDUSTRY name: Nationwide Children briefSummary: This phase 1 study seeks to examine the safety and recommended phase 2 dose (RP2D) of BAFF-ligand CAR-T cells (LMY-920) in adult patients with refractory systemic lupus erythematosus (SLE). It is hypothesized that BAFF CAR-T cells will be safe and will improve SLE disease activity scores. conditions: Systemic Lupus Erythematosus studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 18 type: ESTIMATED name: LMY-920 measure: Safety of the Treatment measure: Recommended Phase 2 Dose (RP2D) measure: Efficacy of the Treatment: SELENA-SLEDAI measure: Efficacy of the Treatment: BILAG measure: Efficacy of the Treatment: PGA sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06340737 id: IRB-73394 briefTitle: AutologousCD22 Chimeric Antigen Receptor (CAR)T Cells in w/Recurrent/Refractory B Cell Lymphomas overallStatus: RECRUITING date: 2024-03-29 date: 2031-04 date: 2031-04 date: 2024-04-01 date: 2024-04-03 name: Stanford University class: OTHER name: The Leukemia and Lymphoma Society briefSummary: This is a non-randomized clinical trial to evaluate the safety and efficacy of CD22CART administered after lymphodepleting chemotherapy in adults with relapsed / refractory B Cell Lymphomas. All evaluable participants will be followed for overall survival (OS), progression free survival (PFS), and duration of response (DOR). An evaluable participant is one who completes leukapheresis, lymphodepleting chemotherapy and CART infusion. conditions: Follicular Lymphoma conditions: Mantle Cell Lymphoma conditions: Hairy Cell Leukemia conditions: Lymphoplasmacytic Lymphoma conditions: Burkitt Lymphoma conditions: Marginal Zone Lymphoma conditions: Waldenstrom Macroglobulinemia studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 120 type: ESTIMATED name: CD22CART Infusion measure: Determine the manufacturing feasibility of CD22 CART by assessing the target dose level and release specifications in each disease cohort. measure: Maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D) measure: Determine the overall response rate (ORR) in adults with follicular lymphoma (FL) and mantle cell lymphoma (MCL) measure: Evaluate Progression Free Survival (PFS) measure: Evaluate Overall Survival (OS) measure: Evaluate Duration of Response (DOR) measure: Assess the response rate in adults with relapsed/refractory Hairy cell leukemia (HCL), Lymphoplasmacytic lymphoma (Waldenstrom macroglobulemia) (WM), Burkitt lymphoma (BL), and Marginal Zone lymphoma (MZL). sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Stanford University status: RECRUITING city: Palo Alto state: California zip: 94304 country: United States name: Kelly Chyan role: CONTACT phone: 650-625-8130 email: kchyan@stanford.edu name: Matthew Frank, MD role: PRINCIPAL_INVESTIGATOR lat: 37.44188 lon: -122.14302 hasResults: False
<\|newrecord\|> nctId: NCT06340724 id: KY20240123-08 briefTitle: Banxiaxiexin Decoction Combined With Vonoprazan-Amoxicillin Dual Therapy in H.Pylori Eradication overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-10 date: 2025-03 date: 2024-04-01 date: 2024-04-01 name: Nanjing First Hospital, Nanjing Medical University class: OTHER briefSummary: Vonoprazan and high-dose amoxicillin dual therapy was used as a control group to evaluate the clinical effiency and safety of Banxiaxiexin decoction combined with vonoprazan and high-dose amoxicillin dual therapy in the treatment of helicobacter pylori infection complicated with functional dyspepsia,through a randomized controlled trail. conditions: Helicobacter Pylori Infection studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 100 type: ESTIMATED name: Vonoprazan name: Amoxicillin name: Banxiaxiexin decotion measure: Change from Baseline in functional dyspepsia symptoms at 6 weeks measure: Change in Traditional Chinese Medicine syndromes from Baseline to 6 weeks measure: Adverse reactions that occur after taking medication measure: Patients' drug compliance sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Nanjing First Hospitai city: Nanjing state: Jiangsu zip: 210006 country: China name: Wenjuan Wei, Doctorate role: CONTACT phone: +8618851009006 email: wjwei.hf@hotmail.com lat: 32.06167 lon: 118.77778 hasResults: False
<\|newrecord\|> nctId: NCT06340711 id: 23-06026219 briefTitle: Study of Suratadenoturev (OBP-301) in Combination With Pembrolizumab in Esophagogastric Adenocarcinoma overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-04 date: 2028-04 date: 2024-04-01 date: 2024-04-01 name: Weill Medical College of Cornell University class: OTHER name: Merck Sharp & Dohme LLC name: Oncolys BioPharma Inc briefSummary: The goal of this study is to learn about of the research study drug, telomelysin (OBP-301), in combination with pembrolizumab in advanced or metastatic gastric or gastroesophageal junction (GEJ) cancer. The main question it aims to answer is whether this combination is safe and effective in this type of cancer.
Participants will receive 5 injections of OBP-301, approximately every 2 weeks. OBP-301 will be injected directly into the tumor during an esophagogastroduodenoscopy (EGD). At the same time as the injection, a tumor biopsy will be taken. Participants will also receive pembrolizumab infusions every 6 weeks until disease progression or for a maximum of two years. Pembrolizumab infusions will occur on different days than OBP-301 injections. conditions: Esophageal Adenocarcinoma conditions: Gastric Adenocarcinoma conditions: Gastroesophageal Junction Adenocarcinoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 27 type: ESTIMATED name: OBP-301 name: Pembrolizumab measure: Overall response rate as assessed by the RECIST v1.1 measure: Number of serious adverse events (SAEs) tabulated by severity and classification per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0 measure: Number of adverse events (AEs) tabulated by severity and classification per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0 measure: Disease control rate (DCR) measure: Duration of response (DoR) measure: Overall Survival (OS) measure: Progression free survival (PFS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Weill Cornell Medicine/NewYork-Presbyterian Hospital city: New York state: New York zip: 10065 country: United States name: Casey Owens role: CONTACT email: cdo4001@med.cornell.edu name: Manish Shah, M.D. role: PRINCIPAL_INVESTIGATOR lat: 40.71427 lon: -74.00597 hasResults: False
<\|newrecord\|> nctId: NCT06340698 id: GRF-11606221 briefTitle: An RCT to Improve HRQoL of HIV+ Mothers and Children overallStatus: RECRUITING date: 2024-02-20 date: 2024-10 date: 2025-02 date: 2024-04-01 date: 2024-04-01 name: City University of Hong Kong class: OTHER briefSummary: The goal of this randomized controlled trial is to test the effectiveness of a resilience intervention and an adherence intervention in improving health-related quality of life (HRQoL) among perinatally infected HIV positive children and their HIV positive mothers in China.
The main questions it aims to answer are:
1. Whether baseline resilience and treatment adherence are associated with the HRQoL;
2. Whether the resilience intervention will improve the mediators associated with intervention sessions, such as positive coping and social support, the proximal outcome of resilience factors, the distal outcome of HRQoL, and dyadic level outcomes such as dyadic coping;
3. Whether the adherence intervention will improve the mediators associated with intervention sessions, such as adherence information and behavioral skills, the proximal outcome of self-reported adherence, the distal outcome of HRQoL, and dyadic level outcomes such as dyadic coping;
4. Whether the enhanced mediators (e.g., positive coping and social support) associated with the resilience-intervention sessions at the end of the intervention will transmit the effect of the resilience intervention on the increases in resilience factors during follow-ups;
5. Whether the improved mediators (e.g., adherence information and behavioral skills) associated with the adherence-intervention sessions at the completion of the intervention will transmit the effect of the adherence intervention on the increases in adherence in follow-ups.
Participating mother-child dyads in the two intervention arms will receive two sessions of dyadic intervention. Researchers will compare the above-described outcomes between participants in the two intervention arms and the control arm (treatment as usual) to see the effectiveness of the interventions. conditions: HIV conditions: Perinatal HIV Infection studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: PARTICIPANT count: 180 type: ESTIMATED name: Resilience intervention name: Adherence intervention measure: Change of health-related quality of life (HRQoL) measure: Change of depressive and anxiety symptoms measure: Change of resilience factors measure: Change of HAART adherence measure: Change of mediators in the resilience intervention: Perceived stigma measure: Change of mediators in the resilience intervention: Emotional regulation measure: Change of mediators in the resilience intervention: Positive coping measure: Change of mediators in the resilience intervention: Social support measure: Change of mediators in the resilience intervention: Self-efficacy measure: Change of mediators in the adherence intervention: Adherence information, motivation, and behavioral skills measure: Change of mediators in the adherence intervention: Illness perception measure: Change of mediators in the adherence intervention: Adherence efficacy measure: Change of mediators in the adherence intervention: Children's medication-taking responsibility measure: Change of mother-child relationship and interaction: Dyadic coping measure: Change of mother-child relationship and interaction: Mother-child closeness measure: Change of mother-child relationship and interaction: Family harmony measure: Change of mother-child relationship and interaction: Mother-child conflict measure: Change of mother-child relationship and interaction: Relationship satisfaction sex: ALL minimumAge: 10 Years maximumAge: 17 Years stdAges: CHILD facility: Guangxi Center for Disease Prevention and Control status: RECRUITING city: Nanning state: Guangxi zip: 530027 country: China name: Xiaoliang Zeng, Dr. role: CONTACT phone: +86 13457089643 email: 41045926@qq.com lat: 22.81667 lon: 108.31667 hasResults: False
<\|newrecord\|> nctId: NCT06340685 id: STUDY23050042 id: UX007-IST236 type: OTHER_GRANT domain: Ultragenyx Pharmaceutical Inc. briefTitle: Triheptanoin for Children With Primary-Specific Pyruvate Dehydrogenase Complex (PDC) Deficiency overallStatus: RECRUITING date: 2024-05 date: 2026-12-31 date: 2027-06-30 date: 2024-04-01 date: 2024-04-04 name: Jirair Krikor Bedoyan class: OTHER name: Ultragenyx Pharmaceutical Inc briefSummary: This is a medical research study to test a medication in patients with a disease called Pyruvate Dehydrogenase Complex (PDC) Deficiency. The medication is triheptanoin, which is currently FDA approved for the treatment of Long-Chain Fatty Acid Oxidation Disorders. Previous research suggests that triheptanoin may also be effective in the treatment PDC Deficiency. This study will investigate the safety and efficacy (how well it works) of triheptanoin in patients with PDC Deficiency. conditions: Pyruvate Dehydrogenase Complex Deficiency studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 6 type: ESTIMATED name: Triheptanoin measure: Number of participants who report side-effects related to gastrointestinal (GI) distress measure: Normalization of biochemical markers of disease (lactate) measure: Normalization of biochemical markers of disease (pyruvate) measure: Normalization of biochemical markers of disease (β-hydroxybutyrate level) measure: Normalization of biochemical markers of disease (Alanine/Leucine ratio) measure: Normalization of biochemical markers of disease (Alanine/Lysine ratio) measure: Normalization of biochemical markers of disease (Alanine/Proline ratio) measure: More efficacious seizure control measure: More efficacious metabolic control measure: More efficacious disease control measure: Improved quality of life measure: Improved long-term maintenance and tolerance of diet measure: Improved quality of life sex: ALL minimumAge: 1 Year maximumAge: 17 Years stdAges: CHILD facility: UPMC Children's Hospital of Pittsburgh status: RECRUITING city: Pittsburgh state: Pennsylvania zip: 15224 country: United States name: Danielle Black, MPH role: CONTACT phone: 412-692-6893 email: danielle.black@chp.edu name: Jirair Bedoyan, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 40.44062 lon: -79.99589 hasResults: False
<\|newrecord\|> nctId: NCT06340672 id: STUDY24010034 briefTitle: The Effect of AR in Patient Pre-operative Education overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2025-02-01 date: 2025-02-01 date: 2024-04-01 date: 2024-04-01 name: University of Pittsburgh class: OTHER briefSummary: The purpose of this clinical trial is to analyze the effect of augmented reality (AR) on patient education and overall satisfaction when used during preoperative counseling in older adults undergoing spinal surgery. The main aims of this study are:
Aim 1: To determine if the use of AR in preoperative consultations is associated with higher levels of patient satisfaction, higher levels of confidence in surgeons, lower levels of preoperative anxiety, and lower patient reported pain scores.
Aim 2: To determine if the use of AR in preoperative consultation will enhance patient education and understanding during the surgical consent process and lead to higher patient retention rates and new patient referrals.
This study will compare AR enhanced preoperative patient counseling with conventional preoperative counseling practices. conditions: Anterior Cervical Discectomy and Fusion conditions: Transforaminal Lumbar Interbody Fusion studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 100 type: ESTIMATED name: Augmented Reality Enhanced Preoperative Counseling name: Standard preoperative counseling measure: Amsterdam Preoperative Anxiety and Information Score (APAIS) survey measure: Simulator Sickness Questionnaire (SSQ) measure: Evaluation of the Experience of General Anesthesia (EVAN-G) Survey measure: Time of preoperatively patient counseling measure: Degree of knowledge acquisition questionnaire at baseline measure: Degree of knowledge acquisition questionnaire 2 weeks post-operative measure: Degree of knowledge acquisition questionnaire 3 months post-operative measure: Degree of knowledge acquisition questionnaire 6 months post-operative measure: Participant age measure: Participant gender measure: Participant's indication for surgery measure: Participant education measure: Participant's past surgeries measure: Names of pain medications measure: Doses of pain medications measure: Prior experience with simulated environments measure: Patient understanding of surgery at baseline measure: Patient understanding of surgery 2 weeks post-operative measure: Patient understanding of surgery 3 months post-operative measure: Patient understanding of surgery 6 months post-operative measure: Patient pain level at baseline measure: Patient pain level 2 weeks post-operatively measure: Patient pain level 3 months post-operatively measure: Patient pain level 6 months post-operatively measure: Confidence in surgeon at baseline measure: Confidence in surgeon 2 weeks post-operatively measure: Confidence in surgeon 3 months post-operatively measure: Confidence in surgeon 6 months post-operatively measure: Patient preoperative visit satisfaction level measure: Patient satisfaction level with the surgical explanation at baseline measure: Patient postoperative visit satisfaction level 2 weeks post-operatively measure: Patient surgery satisfaction level 2 weeks post-operatively measure: Patient postoperative visit satisfaction level 3 months post-operatively measure: Patient surgery visit satisfaction level 3 months post-operatively measure: Patient postoperative visit satisfaction level 6 months post-operatively measure: Patient surgery satisfaction level 6 months post-operatively measure: Patient referral rates measure: Patient retention rates measure: Patient preference on the type of pre-operative counseling received for the AR-specific participants sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: University of Pittsburgh Medical Center city: Pittsburgh state: Pennsylvania zip: 15213 country: United States name: Edward Andrews, MD role: CONTACT phone: 412-232-5666 email: andrewse2@upmc.edu name: Edward Andrews, MD role: PRINCIPAL_INVESTIGATOR lat: 40.44062 lon: -79.99589 hasResults: False
<\|newrecord\|> nctId: NCT06340659 id: AE and CT briefTitle: Concurrent Aerobic Exercise and Cognitive Training to Prevent Alzheimer's in At-risk Older Adults (The Exergames Telerehabilitation Study) overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2027-07-01 date: 2027-07-01 date: 2024-04-01 date: 2024-04-01 name: University of Minnesota class: OTHER briefSummary: Significance of Research Question/Purpose: Subjective cognitive decline (SCD) is regarded as the first clinical manifestation in the AD-dementia continuum and currently has a prevalence of 11.2% in adults over the age of 45, with incidence increasing with greater age. Furthermore, population-based studies suggest that between 50% and 80% of older individuals (aged 70 years and older) who perform normally on cognitive tests, report some form of perceived decline in cognitive functioning when asked. The SCD state is unique as this population is more likely than their healthy peers to present with AD biomarkers such as neurodegeneration and amyloid burden, and therefore represents probable preclinical AD relative to other causes of SCD. Likewise, growing evidence suggests that a significant proportion of those adults are subsequently found to develop MCI, or AD, following the classic SCD-MCI-AD trajectory, with SCD increasing MCI risk 1.5-3 fold. Preventing Alzheimer's disease (AD) is arguably the most important approach to address the dementia epidemic worldwide because 99.6% of drug trials failed and no drugs can yet prevent, cure, or even slow AD. A treatment that delays the onset of AD by five years could save $89 billion in 2030.This highlights an urgent and pressing need to develop behavioral interventions to prevent AD and slow its progression.
The first purpose is to develop a fully-featured version of the Virtual Reality Cognitive Training (VRCT) aspect of the Exergame that can be installed and updated remotely. We will build on the Phase II Exergame by creating the capability that allows it to be installed and updated remotely to facilitate home-based use, especially by older adults. This also helps address a strong preference from our Phase II participants to minimize interaction with outsiders due to the ongoing COVID-19 pandemic, indicating a home- based solution will greatly facilitate commercialization. The second purpose is to determine the efficacy of the Home-based (Hb)Exergame on cognition and aerobic fitness in older adults at risk for AD using a 2:2 factorial design clinical trial. We will measure the following outcomes quantitatively: a) cognition: fluid cognition (global cognition) as the primary outcome, processing speed and other cognitive domains as secondary outcomes; b) aerobic fitness, c) neuroprotective blood biomarkers. conditions: AD-dementia studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: FACTORIAL interventionModelDescription: This study will use a single-blind, randomized, 2:2 factorial design. will randomize 104 community-dwelling older adults to one of four arms for 3 months: home-based (asynchronous) Exergame (HbExergame), supervised Exergame, home-based asynchronous aerobic exercise (HbAEx, or supervised aerobic exercise (supervised AEx). Randomization will allocate subjects on a 1:1:1:1 allocation ratio within each age stratum (65-74 and ≥75) in random blocks of 8 or 4 primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 104 type: ESTIMATED name: Supervised AEx name: HbAEx name: Supervised Exergame name: HbExergame measure: fluid cognition (global cognition) measure: Cognitive Function measure: Aerobic fitness measure: Neuroprotective biomarkers and ApoE status. measure: Exergame-specific usability and satisfaction measure: Standing balance measure: Four-meter walking velocity measure: Repeated chair raise measure: Quality of Life (QoL) measure: SCD Symptoms sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06340646 id: 202106129 id: U2CCA252981 type: NIH link: https://reporter.nih.gov/quickSearch/U2CCA252981 briefTitle: Washington University Participant Engagement and Cancer Genomic Sequencing Center (WU-PE-CGS) overallStatus: RECRUITING date: 2022-10-18 date: 2027-01-31 date: 2027-01-31 date: 2024-04-01 date: 2024-04-01 name: Washington University School of Medicine class: OTHER name: National Cancer Institute (NCI) name: The Foundation for Barnes-Jewish Hospital briefSummary: The overall goal of the WU-PE-CGS is to build a rigorous, scientific evidence base for approaches that direct engagement of cancer patients and post-treatment cancer survivors as participants in cancer research, and to investigate the impact of directly engaging participants in decisions regarding returning of genomic results on participants' health and satisfaction. Participants in this study will be presented with the choice of types of genomic results to receive, and the Engagement Optimization Unit (EOU) will investigate the impact of this intervention on participant knowledge, expectations of benefit, personal utility, and decisional conflict. conditions: Cholangiocarcinoma conditions: Multiple Myeloma conditions: Colon Cancer conditions: Rectal Cancer studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 990 type: ESTIMATED name: Return of Genetic Results: Biomarker information from cancer cells name: Return of Genetic Results: Inherited mutations related to cancer name: Return of Genetic Results: Inherited mutations related to other medical issues measure: Participant knowledge of clinical genetic testing measure: Participant expectations of benefit measure: Participant personal utility measure: Participant anxiety measure: Participant satisfaction sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Washington University School of Medicine status: RECRUITING city: Saint Louis state: Missouri zip: 63110 country: United States name: Graham Colditz, M.D., DrPH, MPH role: CONTACT phone: 314-454-7939 email: colditzg@wustl.edu name: Bettina Drake, Ph.D., MPH role: CONTACT phone: 314-747-4534 email: drakeb@wustl.edu name: Graham Colditz, M.D., DrPH, MPH role: PRINCIPAL_INVESTIGATOR name: Li Ding, Ph.D. role: SUB_INVESTIGATOR name: Bettina Drake, Ph.D. role: SUB_INVESTIGATOR name: Ryan Fields, M.D. role: SUB_INVESTIGATOR name: Yin Cao, ScD, MPH role: SUB_INVESTIGATOR name: Feng Chen, Ph.D. role: SUB_INVESTIGATOR name: Kia Davis, ScD, MPH role: SUB_INVESTIGATOR name: Patricia Dickson, M.D. role: SUB_INVESTIGATOR name: Eric Duncavage, M.D. role: SUB_INVESTIGATOR name: Mark Fiala, MSW role: SUB_INVESTIGATOR name: Aimee James, Ph.D., MPH role: SUB_INVESTIGATOR name: Reyka Jayasinge, Ph.D. role: SUB_INVESTIGATOR name: Kian-Huat Lim, M.D., Ph.D. role: SUB_INVESTIGATOR name: Erin Linnenbringer, Ph.D., MS role: SUB_INVESTIGATOR name: Jessica Mozersky, Ph.D. role: SUB_INVESTIGATOR name: Mary Politi, Ph.D. role: SUB_INVESTIGATOR name: David Spencer, M.D., Ph.D. role: SUB_INVESTIGATOR name: Tunji Toriola, M.D., Ph.D., MPH role: SUB_INVESTIGATOR name: Ravi Vij, M.D., MBA role: SUB_INVESTIGATOR name: Mark Watson, M.D., Ph.D. role: SUB_INVESTIGATOR name: Fei Wan, Ph.D. role: SUB_INVESTIGATOR name: Mike Wendl, DSC, MS, PHS role: SUB_INVESTIGATOR name: Matthew Wyczalkowsi, Ph.D. role: SUB_INVESTIGATOR name: Stephanie Solomon Cargill, Ph.D., MSPH role: SUB_INVESTIGATOR lat: 38.62727 lon: -90.19789 hasResults: False
<\|newrecord\|> nctId: NCT06340633 id: SPI-1005-261 briefTitle: SPI-1005 in Adults Receiving Cochlear Implant overallStatus: NOT_YET_RECRUITING date: 2024-07 date: 2025-12 date: 2025-12 date: 2024-04-01 date: 2024-04-01 name: Sound Pharmaceuticals, Incorporated class: INDUSTRY name: Med-El Corporation briefSummary: The goal of this clinical trial is to learn about the effects of drug SPI-1005 in adults receiving a cochlear implant with a long electrode array (FLEX26 or greater) from MED-EL Cochlear Implant Systems into one ear.
The main question this clinical trial aims to answer is: Is drug SPI-1005 safe and well-tolerated in adults receiving a cochlear implant, and/or what medical problems might participants experience when taking drug SPI-1005?
The clinical trial will also measure the effects of SPI-1005 on hearing, word recognition, speech discrimination, tinnitus, and vertigo outcomes after receiving a cochlear implant. The purpose for this and future clinical trials is to learn whether SPI-1005 can prevent or treat these side effects after receiving a cochlear implant.
Participants will take drug SPI-1005 or placebo (a look-alike substance that contains no drug) for 6 months, starting 2 days before receiving the cochlear implant. There are 5 required in-clinic visits over 6 months for audiology and other tests.
The effects of SPI-1005 will be compared to the placebo (the look-alike substance that contains no drug) to study what effects SPI-1005 might have. conditions: Hearing Loss conditions: Cochlear Trauma studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: Ebselen name: Placebo measure: Number of Participants with Treatment Emergent Adverse Events (TEAE) measure: Effect of SPI-1005 on Residual Low Frequency Hearing measure: Effect of SPI-1005 on Word Recognition measure: Effect of SPI-1005 on Speech Discrimination measure: Effect of SPI-1005 on Tinnitus measure: Effect of SPI-1005 on Vertigo sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06340620 id: 24.017.01 briefTitle: EUS Examination Using EndoSound Vision System vs. Standard Echoendoscope overallStatus: RECRUITING date: 2024-03-25 date: 2026-12 date: 2027-12 date: 2024-04-01 date: 2024-04-01 name: Orlando Health, Inc. class: OTHER briefSummary: This is a randomized trial to compare the standard echoendoscope with the newly developed EndoSound Visual System in the evaluation of lesions in the gastrointestinal tract. conditions: Pancreatic Disease conditions: Pancreatic Cancer conditions: Pancreatic Cyst conditions: Gastrointestinal Tumor conditions: Bile Duct Diseases conditions: Bile Duct Cancer conditions: Lymph Node Disease conditions: Submucosal Tumor of Gastrointestinal Tract conditions: Gastrointestinal Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: DIAGNOSTIC masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 140 type: ESTIMATED name: Endoscopic ultrasound examination measure: Rate of successful completion of the requisite EUS examination measure: Ease of maneuverability of the device measure: Quality of EUS imaging measure: Ease of performing tissue acquisition measure: Diagnostic adequacy of procured specimen on onsite evaluation measure: Diagnostic adequacy of procured specimen in cell block measure: Diagnostic accuracy of procured specimen measure: Procedure duration measure: Rate of procedure-related adverse events measure: Procedure costs sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Orlando Health status: RECRUITING city: Orlando state: Florida zip: 32806 country: United States name: Ji Young Bang, MD MPH role: CONTACT phone: 321-841-2431 email: jiyoung.bang@orlandohealth.com name: Barbara Broome role: CONTACT phone: 321-841-4356 email: barbara.broome@orlandohealth.com lat: 28.53834 lon: -81.37924 hasResults: False
<\|newrecord\|> nctId: NCT06340607 id: 2023-0561 briefTitle: Neohepatic Albumin-Bilirubin Scores on Renal Outcomes in Living-donor Liver Transplantation Recipients overallStatus: COMPLETED date: 2012-01-05 date: 2020-01-05 date: 2022-12-31 date: 2024-04-01 date: 2024-04-01 name: Asan Medical Center class: OTHER briefSummary: This study investigates the association between post-reperfusion (neohepatic) ALBI scores and post-LT renal outcomes in living-donor LT (LDLT) recipients. conditions: Acute Kidney Injury conditions: Chronic Kidney Diseases conditions: Graft Failure studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 3422 type: ACTUAL measure: acute kidney injury measure: chronic kidney injury measure: graft failure sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Asan Medical Center city: Seoul state: Song-pa Gu zip: 05500 country: Korea, Republic of lat: 37.566 lon: 126.9784 hasResults: False
<\|newrecord\|> nctId: NCT06340594 id: RF-2-2024 briefTitle: Single-stage ERCP and Laparoscopic Cholecystectomy for Cholecystocholedocholithiasis: Which to Start With? overallStatus: COMPLETED date: 2021-01-01 date: 2023-12-01 date: 2024-01-30 date: 2024-04-01 date: 2024-04-02 name: Assiut University class: OTHER briefSummary: Chronic calculous cholecystitis is associated with common bile duct (CBD) stones in approximately 12% of patients. These patients need both cholecystectomy and CBD clearance of stones. The standard for cholecystectomy is laparoscopic cholecystectomy (LC) and the mostly common treatment used for CBD clearance is Endoscopic Retrograde Cholangiopancreatography (ERCP). The two interventions can be combined to be done at the same time under single anesthesia session. Studies of single stage ERCP+LC showed confirmed the safety and efficacy of the combined technique. However, some surgeons start with the ERCP while others start with LC.The aim of this study is to compare the start with ERCP followed by LC to the start with LC followed by ERCP when the two techniques are combined at the same session for treatment of chronic calculous cholecystitis associated with CBD stones regarding efficacy and safety of the two approaches. conditions: Choledocholithiasis With Cholecystitis conditions: Biliary Stones studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 115 type: ACTUAL name: Laproscopic cholecystectomy (LC) name: Endoscopic Retrograde Cholangiopancreatography (ERCP) measure: Operative time operative time measure: CBD clearance rate measure: Length of hospital stay measure: Mortality rate sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Faculty of Medicine-Assiut University -Assiut-Egypt city: Assiut state: Asyut zip: 71515 country: Egypt lat: 27.18096 lon: 31.18368 hasResults: False
<\|newrecord\|> nctId: NCT06340581 id: D5985C00009 id: 2023-509914-12 type: OTHER domain: EU CT briefTitle: A Study to Assess the Lung Exposure Bioequivalence of Budesonide, Glycopyrronium, & Formoterol (BGF) Metered Dose Inhaler (MDI) Hydrofluoroolefin (HFO) With a Spacer (Treatment B), BGF MDI Hydrofluoroalkane (HFA) With a Spacer (Treatment A), as Well as BGF MDI HFO Without a Spacer (Treatment C). overallStatus: NOT_YET_RECRUITING date: 2024-06-17 date: 2024-10-28 date: 2024-10-28 date: 2024-04-01 date: 2024-04-01 name: AstraZeneca class: INDUSTRY name: Parexel briefSummary: The purpose of this study is to assess the bioequivalence of the lung exposure of budesonide, glycopyrronium, and formoterol administered as budesonide, glycopyrronium, formoterol (BGF) metered dose inhaler (MDI) hydrofluoroolefin (HFO) with AeroChamber Plus Flow-Vu spacer compared with BGF MDI hydrofluoroalkane (HFA) with AeroChamber Plus Flow Vu spacer And BFG MDI HFO (Spacer vs No Spacer). conditions: Healthy studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 132 type: ESTIMATED name: Treatment A: BGF MDI HFA name: Treatment B: BGF MDI HFO name: Treatment C: BGF MDI HFO name: AeroChamber Plus Flow-Vu Spacer measure: Area Under the Plasma Concentration-curve from Zero to the Last Quantifiable Concentration (AUClast) of BGF MDI measure: Maximum Observed Concentration (Cmax) of BGF MDI measure: Area Under the Plasma Concentration-curve from Zero to the Last Quantifiable Concentration (AUClast) measure: Maximum Observed Concentration (Cmax) measure: Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUCinf) measure: Time to Reach Maximum Observed Concentration (tmax) measure: Terminal Rate Constant (λz) measure: Half-life Associated with Terminal Slope (λz) of a Semi-logarithmic Concentration-time Curve (t1/2λz) measure: Mean Residence Time of the Unchanged Drug in the Systemic Circulation from Zero to Infinity (MRTinf) measure: Apparent Total Body Clearance of Drug from Plasma After Extravascular Administration (CL/F) measure: Apparent Volume of Distribution at Steady State Following Extravascular Administration (Vz/F) measure: Number of Participants with Adverse Events sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT hasResults: False
<\|newrecord\|> nctId: NCT06340568 id: BNT323-01 id: GOG-3105 type: OTHER domain: GOG foundation id: 2023-507525-42-00 type: OTHER domain: EU CT id: ENGOT- en25/NSGO-CTU type: OTHER domain: European Network for Gynaecological Oncological Trial groups (ENGOT) briefTitle: A Clinical Study of the Anti-cancer Effects of an Investigational Therapy or Chemotherapy in Patients With Recurring Uterine Cancer overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-10 date: 2028-08 date: 2024-04-01 date: 2024-04-01 name: BioNTech SE class: INDUSTRY name: DualityBio Inc. briefSummary: The goal of this clinical study is to assess the efficacy of BNT323/DB-1303 compared with investigator's choice of chemotherapy in terms of progression-free survival (PFS) by blinded independent central review (BICR) in the endometrial cancer population. conditions: Endometrial Cancer studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 468 type: ESTIMATED name: BNT323/DB-1303 name: Doxorubicin name: Paclitaxel measure: PFS by BICR in the endometrial cancer population measure: Overall survival (OS) in the endometrial cancer population measure: PFS assessed by the investigator in the endometrial cancer population measure: Objective response rate (ORR) in the endometrial cancer population measure: Duration of response (DoR) in the endometrial cancer population measure: Number of patients with occurrence of treatment-emergent adverse events (TEAEs) measure: Number of patients with occurrence of dose reduction, delay, and discontinuation of study treatments due to TEAEs sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06340555 id: PIC-156-22 briefTitle: Intervention to Prevent Mental Health Disorders of Women and Their Partners Who Experienced Pregnancy Loss acronym: Enzo overallStatus: ACTIVE_NOT_RECRUITING date: 2024-03-01 date: 2024-12-31 date: 2025-07-31 date: 2024-04-01 date: 2024-04-01 name: Fundació Sant Joan de Déu class: OTHER name: University of Barcelona name: University of Seville briefSummary: The goal of this clinical trial is to test impact of a multiprofessional intervention in mothers and partners who suffer a pregnancy loss. The main questions it aims to answer are:
* impact on mothers and partners mental heatlht status
* reasons why mothers do not consent to the intervention
Participants will:
* mothers and partners will complete 4 scales
* mothers and partners will participate in a interview
Researchers will compare with mothers with standard care to see if the multiprofessional intervention has an impact. conditions: Stillbirth and Fetal Death studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 120 type: ESTIMATED name: GUIA ATENCION MULTIDISCIPLINAR SANT BOI name: USUAL CARE measure: Intensity of grief measure: Depressive symptoms measure: Anxiety symptoms measure: Perinatal postraumatic stress disorder sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Parc Sanitari Sant Joan de Deu city: Sant Boi De Llobregat state: Barcelona zip: 08830 country: Spain lat: 41.34357 lon: 2.03659 hasResults: False
<\|newrecord\|> nctId: NCT06340542 id: UDhaka briefTitle: Comparison of Thoracic Mobility Exercise Versus Manual Release Technique in Minimizing Upper Back Pain overallStatus: COMPLETED date: 2023-11-01 date: 2023-12-31 date: 2024-01-31 date: 2024-04-01 date: 2024-04-02 name: University of Dhaka class: OTHER briefSummary: Methodology: study aims to evaluate the effectiveness of thoracic mobility exercise and manual release technique in terms of pain intensity, thoracic mobility, muscle strength and improving disability.
Study Design: Study was conducted in Service unit of Department of Physiotherapy at university of peradeniya. Undergraduates who are currently having upper back pain for more than seven days was selected as sample. It is a randomized Controlled trail, Double blinded study. Participants allowed randomly to both groups which are experimental group which will receive thoracic mobility exercises and control group which will receive myofascial release and joint mobilization treatment. Total sample size was 60. conditions: Upper Back Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This study is a Randomized Control Trial, Double- Blinded study. Participants and accessors was blinded. Participants were allocated randomly in to two groups which are experimental group which will receive thoracic mobility exercises and control group which will receive myofascial release and joint mobilization treatment by using lottery method. primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Participants' allocation was concealed by using lottery method whether there are in exercise group or manual therapy group. Accessors was blinded which means they were not aware about the treatment or therapy which was obtained by the participants whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 57 type: ACTUAL name: Thoracic Mobility exercises name: Manual Release technique measure: Pain Intensity measure: Range of Motion measure: Muscle strength measure: Disability level - self perception sex: ALL minimumAge: 20 Years maximumAge: 26 Years stdAges: ADULT facility: Vithursha Sivakumar city: Jaffna state: Northern zip: 40001 country: Sri Lanka lat: 9.66845 lon: 80.00742 typeAbbrev: Prot_SAP_ICF hasProtocol: True hasSap: True hasIcf: True label: Study Protocol, Statistical Analysis Plan, and Informed Consent Form date: 2023-10-09 uploadDate: 2024-03-25T22:35 filename: Prot_SAP_ICF_000.pdf size: 1324441 hasResults: False
<\|newrecord\|> nctId: NCT06340529 id: CLS_SIMULATION briefTitle: Comparison of the Perception of Non-technical Skills overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2024-05-31 date: 2024-06-30 date: 2024-04-01 date: 2024-04-03 name: University of Valencia class: OTHER briefSummary: Clinical simulation has recently acquired great importance in the health sciences. It is a pedagogical methodology that is increasingly used in health science degrees, since it is very useful for the acquisition of both technical and non-technical skills (leadership, teamwork and effective communication, among others).
However, if the investigators focus on physical therapy, the use of clinical simulation is a novel field and therefore requires a great deal of research. Researchers in this field do not yet have the consistency and experience as in other health branches such as medicine or nursing, where the participants have been using high-fidelity simulators for years for the learning of all their students.
Clinical simulation allows students to achieve these competencies without the need to practice on real patients. For all these reasons, and because of the situation of need generated in recent years, in which internships in hospitals and clinical centers were completely suppressed, the need for our research is justified. conditions: Healthy studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: SCREENING masking: NONE count: 100 type: ESTIMATED name: Clinical Simulation measure: Ottawa Scale sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06340516 id: HER2BNP briefTitle: NT-proBNP to Assess Trastuzumab-induced Cardiotoxicity overallStatus: RECRUITING date: 2024-03-14 date: 2029-03-14 date: 2029-03-14 date: 2024-04-01 date: 2024-04-01 name: Vastra Gotaland Region class: OTHER_GOV briefSummary: Trastuzumab-induced cardiotoxicity (TIC) will be monitored in patients with HER2+ breast cancer undergoing trastuzumab treatment before and after breast cancer surgery. At baseline before start of trastuzumab treatment, echocardiography (ECHO)/multigated Acquisition Scan (MUGA) and measurement of plasma NT-proBNP will be performed. NT-proBNP will be measured again at 6 months and at 12 months of trastuzumab treatment. If elevations in NT-proBNP at 6 months and 12 months occur patients will be referred for ECHO/MUGA. The aim is to assess the sensitivity and specificity to detect TIC with NT-proBNP and whether ECHO/MUGA can be safely replaced by assessment of plasma NT-proBNP levels. conditions: Cardiotoxicity conditions: Breast Cancer conditions: Treatment Side Effects studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: This is a national multicentre phase II trial investigating the sensitivity and specificity of NT-proBNP for the diagnose of cardiac toxicity during primary anti-HER2 blockade. NT-proBNP is compared with the todays´ standard (ECHO/MUGA). primaryPurpose: DIAGNOSTIC masking: NONE count: 700 type: ESTIMATED name: Plasma NT-proBNP measure: Sensitivity and specificity of NT-proBNP to detect trastuzumab-induced cardiotoxicity measure: Prevalence of trastuzumab-induced cardiotoxicity measure: Anthracycline-induced change in NT-proBNP sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Jubileumskliniken, Sahlgrenska University Hospital status: RECRUITING city: Gothenburg zip: 432 45 country: Sweden name: Daniel Giglio, Assoc Prof role: CONTACT phone: +46(0)31-342 16 06 email: daniel.giglio@pharm.gu.se lat: 57.70716 lon: 11.96679 hasResults: False
<\|newrecord\|> nctId: NCT06340503 id: IRB00111331 id: WFBCCC 01123 type: OTHER domain: Atrium Health Wake Forest Baptist Comprehensive Cancer Center id: P30CA012197 type: NIH link: https://reporter.nih.gov/quickSearch/P30CA012197 briefTitle: Evaluating a Physical Activity Index for Assessment and Counseling for Breast and Colon Cancer Survivors overallStatus: NOT_YET_RECRUITING date: 2024-07 date: 2025-07 date: 2025-08 date: 2024-04-01 date: 2024-04-01 name: Wake Forest University Health Sciences class: OTHER name: National Cancer Institute (NCI) briefSummary: The purpose of this research study is to determine whether using the physical activity index screener, exercise coaching, and self-monitoring will increase physical activity and reduce time spent sitting or being inactive in patients who had breast or colon cancer. conditions: Breast Cancer conditions: Colon Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 20 type: ESTIMATED name: Research-grade accelerometer name: National Comprehensive Cancer Network (NCCN) Education Materials name: Garmin Vivofit activity tracker name: Exercise Consultation Calls name: Interview name: Physical Activity Index Assessment (Intervention Arm) name: Physical Activity Index Assessment (Control Arm) name: Health Surveys measure: Number of Eligible Participants - Participation Rate measure: Percentage of Participants to Complete Exercise Sessions - Adherence measure: Number of Participants Who Complete Study Questionnaires - Retention sex: ALL minimumAge: 50 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Atrium Health Wake Forest Baptist Comprehensive Cancer Center city: Winston-Salem state: North Carolina zip: 27157 country: United States name: Principal Investigator role: CONTACT name: Shirley Bluethmann, PhD role: PRINCIPAL_INVESTIGATOR lat: 36.09986 lon: -80.24422 hasResults: False
<\|newrecord\|> nctId: NCT06340490 id: RJMty19-AID002 briefTitle: A Study of RJMty19 in Refractory Systemic Lupus Erythematosus (SLE) overallStatus: NOT_YET_RECRUITING date: 2024-05-15 date: 2026-12-31 date: 2027-12-31 date: 2024-04-01 date: 2024-04-01 name: Guangdong Ruishun Biotech Co., Ltd class: INDUSTRY name: RenJi Hospital name: Peking University People's Hospital name: Changhai Hospital name: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School briefSummary: This study is an open-label, single-arm, dose escalation and dose expansion study to evaluate the safety, maximum tolerated dose, pharmacokinetic characteristics of allogeneic CD19-CAR-DNT cells (RJMty19) after infusion, and preliminary efficacy in systemic lupus erythematosus (SLE) subjects. conditions: Systemic Lupus Erythematosus studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 24 type: ESTIMATED name: RJMty19 (CD19-CAR-DNT cells) measure: Dose-Limiting Toxicity (DLT) measure: Maximum Tolerated Dose (MTD) measure: Incidence of abnormalities measure: Pharmacokinetics (PK) indicator (Cmax) measure: Pharmacokinetics (PK) indicator (AUC) measure: Pharmacokinetics (PK) indicator (CAR copy numbers) measure: Remission rate of SLE based on DORIS criteria measure: Remission rate of SLE based on LLDAS criteria sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Peking University People's Hospital city: Beijing state: Beijing zip: 100044 country: China name: Zhanguo Li, MD, PHD role: CONTACT phone: +086-13910713924 email: li99@bjmu.edu.cn name: Chun Li, MD, PHD role: CONTACT phone: +086-13811190098 email: 13811190098@163.com lat: 39.9075 lon: 116.39723 facility: Nanjing Drum Tower Hospital city: Nanjing state: Jiangsu zip: 210008 country: China name: Lingyun Sun, MD, PhD role: CONTACT phone: +086-025-83105555 email: lingyunsun2012@163.com lat: 32.06167 lon: 118.77778 facility: Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine city: Shanghai state: Shanghai zip: 200001 country: China name: Shuang Ye, MD, PHD role: CONTACT phone: +086-13817615871 email: ye_shuang2000@163.com name: Qiong Fu, MD, PHD role: CONTACT phone: +086-13585603288 email: fuqiong@renji.com lat: 31.22222 lon: 121.45806 facility: Changhai Hospital city: Shanghai state: Shanghai zip: 200433 country: China name: Dongbao Zhao, MD, PhD role: CONTACT phone: +86-15921061314 email: dongbaozhao@163.com name: Jie Gao, MD, PhD role: CONTACT phone: +086-13585561861 email: gaojif@tom.com lat: 31.22222 lon: 121.45806 hasResults: False
<\|newrecord\|> nctId: NCT06340477 id: Mahnoor Arif/ REC -01802 briefTitle: Effect of Thoracic SNAGS on Vitals Among Individuals With Forward Head Posture overallStatus: RECRUITING date: 2024-03-01 date: 2024-06 date: 2024-07 date: 2024-04-01 date: 2024-04-01 name: Riphah International University class: OTHER briefSummary: To determine how vitals (heart rate, blood pressure, respiratory rate, oxygen saturation) and craniovertebral angle will be affected by thoracic SNAGs in individuals with forward head posture. conditions: Neck Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 28 type: ESTIMATED name: Thoracic SNAGs with conventional therapy name: conventional therapy measure: Aneroid sphygmomanometer measure: Pulse oximeter measure: Respiratory rate measure: NPRS (Numeric Pain Rating Scale) measure: Inclinometer measure: Photogrammetric method for craniovertebral angle sex: ALL minimumAge: 30 Years maximumAge: 50 Years stdAges: ADULT facility: Pakistan Railway Hospital status: RECRUITING city: Rawalpindi state: Punjab zip: 46000 country: Pakistan name: Maria Khalid, MSOMPT role: CONTACT phone: 03315369768 email: maria.khalid@riphah.edu.pk name: Mahnoor arif, MSOMPT* role: CONTACT name: mahnoor arif, MSOMPT* role: PRINCIPAL_INVESTIGATOR lat: 33.6007 lon: 73.0679 hasResults: False
<\|newrecord\|> nctId: NCT06340464 id: REC.67-018-8-1 briefTitle: Preoperative Nutritional Status Scores to Predict PPC in Elderly With Cardiac Surgery overallStatus: RECRUITING date: 2024-03-21 date: 2025-12-31 date: 2026-11-30 date: 2024-04-01 date: 2024-04-01 name: Prince of Songkla University class: OTHER briefSummary: This prospective study investigate prognostic values and compare the role of nutritional status by using GNRI, MNA, and PNI in predicting post-operative pulmonary complication among elderly patients with cardiac surgery. conditions: Cardiac Surgery conditions: Elderly Patient conditions: Postoperative Pulmonary Complication conditions: Nutrition Scoring System studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 229 type: ESTIMATED name: GNRI, PNI, MNA measure: Postoperative pulmonary complication sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Anesthesiology, Faculty of Medicine, Prince of Songkla University status: RECRUITING city: Hat Yai state: Songkhla zip: 90110 country: Thailand name: Panalee Kittisopaporn role: CONTACT phone: 66832422540 lat: 7.00836 lon: 100.47668 hasResults: False
<\|newrecord\|> nctId: NCT06340451 id: IOV-301 briefTitle: Study to Assess the Efficacy and Safety of Iovera®° System in Subjects With Upper Extremity Spasticity overallStatus: RECRUITING date: 2024-04-16 date: 2025-04 date: 2025-04 date: 2024-04-01 date: 2024-04-23 name: Pacira Pharmaceuticals, Inc class: INDUSTRY briefSummary: This multicenter, randomized, double-blind, sham-controlled study is designed to evaluate the efficacy and safety of the iovera° system in subjects with upper extremity spasticity. A total of approximately 132 subjects will be enrolled; 88 subjects will receive treatment with the iovera° system and 44 subjects will receive sham treatment (sham iovera° system treatment). conditions: Spasticity, Cerebral or Spinal Condition studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 132 type: ESTIMATED name: iovera° system name: sham iovera° system treatment measure: Change from baseline in the Modified Ashworth Scale score for elbow measured (0 to 4, where lower scores represent normal muscle tone and higher scores represent spasticity) measure: Change from baseline in the Modified Ashworth Scale) score for shoulder (shoulder abduction) measured measure: Change from baseline in the Modified Tardieu Scales for elbow (0 to 5, where lower score represents no resistance, and higher score represents joint immobility; Increase in angle from baseline [R1, and R2] represents improvement) measure: Change from baseline in the Modified Tardieu Scales for shoulder (shoulder abduction) measure: Change from baseline in Goal Attainment Scale score evaluated by the blinded, trained, licensed medical staff (-2 to +2, where lower score represents less expected outcomes, and higher scores represent greater expected outcomes) measure: Change from baseline in the Modified Ashworth Scale score for elbow measured immediately (within 3 hours) measure: Change from baseline in the Modified Ashworth Scale score for shoulder (shoulder abduction) measured immediately (within 3 hours) measure: Change from baseline in the Modified Ashworth Scale score for shoulder (forward flexion, external rotation) measured immediately (within 3 hours) measure: Change from baseline in the Modified Ashworth Scale score over 13 weeks post-treatment measured by area under the curve (AUC) for elbow (elbow extension) measure: Change from baseline in the Modified Ashworth Scale score over 13 weeks post-treatment measured by AUC for shoulder (shoulder abduction, shoulder forward flexion, external rotation) measure: Change from baseline in the Modified Tardieu Scales for elbow measured immediately (within 3 hours) measure: Change from baseline in the Modified Tardieu Scales for shoulder (shoulder abduction) measured immediately (within 3 hours) measure: Change from baseline in the Modified Tardieu Scales for shoulder (forward flexion, external rotation) measured immediately (within 3 hours) measure: Change from baseline in Goal Attainment Scale score evaluated by the blinded, trained, licensed medical staff sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Shepherd Center status: RECRUITING city: Atlanta state: Georgia zip: 30309 country: United States name: Michelle Tidwell role: CONTACT phone: 404-367-1317 email: michelle.tidwell@shepherd.org lat: 33.749 lon: -84.38798 hasResults: False
<\|newrecord\|> nctId: NCT06340438 id: N-20240004 3rd subproject briefTitle: Investigate the Relationship Between Catastrophizing and the Perception of Itch Intensity in Healthy Individuals overallStatus: NOT_YET_RECRUITING date: 2024-04-27 date: 2025-12-31 date: 2026-12-31 date: 2024-04-01 date: 2024-04-29 name: Aalborg University class: OTHER briefSummary: This project aims to investigate the relationship between different dimensions of catastrophizing (rumination, magnification, and helplessness) as well as some specific personality traits related to catastrophizing tendencies like anxiety sensitivity and fear sensitivity in the modulation of itch and pain intensities in an experimental setting. conditions: Histamine conditions: Cowhage studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: The participants will randomly receive applications of cowhage and histamine. primaryPurpose: BASIC_SCIENCE masking: SINGLE maskingDescription: Participant will be blinded about application of pruritogens. whoMasked: PARTICIPANT count: 46 type: ESTIMATED name: Histamine name: Cowhage measure: Reinforcement Sensitivity Theory - Personality Questionnaire (RST-PQ). measure: The Pittsburg Sleep Quality Index (PSQI) measure: Depression, Anxiety, Stress Scale (DASS-21) measure: Positive And Negative Affect Schedule (PANAS) measure: Pain Catastrophizing Scale (PCS). measure: Itch Catastrophizing Scale (ICS). measure: Learned Helplessness Scale (LHS) measure: Positive And Negative Affect Schedule (PANAS) measure: Depression, Anxiety, Stress Scale (DASS-21) measure: Positive And Negative Affect Schedule (PANAS) measure: Pain Catastrophizing Scale (PCS). measure: Itch Catastrophizing Scale (ICS). measure: Learned Helplessness Scale (LHS) measure: Positive And Negative Affect Schedule (PANAS) measure: Assessment of itch measure: Assessment of pain sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT hasResults: False
<\|newrecord\|> nctId: NCT06340425 id: s68727 briefTitle: The Effect of Selective Dorsal Rhizotomy on a Multidimensional Outcome Set in Children With Spastic Cerebral Palsy: a Retrospective Study overallStatus: COMPLETED date: 2018-06-26 date: 2023-12-31 date: 2023-12-31 date: 2024-04-01 date: 2024-04-01 name: Universitaire Ziekenhuizen KU Leuven class: OTHER briefSummary: Cerebral palsy or CP is the single largest cause of childhood physical disability, with a prevalence of 2-3 per 1000 livebirths. Children with CP experience different primary symptoms, including abnormal increased muscle tone or spasticity. Selective dorsal rhizotomy (SDR) is applied in children with spastic CP as a non-reversible tone reduction procedure. Better understanding of the effects of SDR on a multidimensional outcome set in one CP-cohort and on macroscopic muscle morphology can improve insights and clinical decision making. conditions: Cerebral Palsy studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 15 type: ACTUAL measure: Overall changes in spasticity measure: Overall change in muscle volume of the medial gastrocnemius measure: Overall changes in muscle length of the medial gastrocnemius measure: Overall changes in muscle cross-sectional area at 50% of muscle belly length measure: Overall changes in gait measure: Overall change in gross-motor function measure: Overall change of spasticity in the plantar flexors measure: Overall change of selectivity in the plantar flexors measure: Overall change of passive range of motion in the ankle and knee joint measure: Overall change of muscle strength in the plantar flexors measure: Scatter plots of muscle morphology data (same parameters as for the primary endpoints) sex: ALL minimumAge: 5 Years maximumAge: 16 Years stdAges: CHILD facility: UZ Leuven city: Leuven state: Vlaams-Brabant zip: 3000 country: Belgium lat: 50.87959 lon: 4.70093 hasResults: False
<\|newrecord\|> nctId: NCT06340412 id: MFGM-FOR-HEALTH briefTitle: Effects of Intact and Disrupted Milk Fat Globule Membrane on Postprandial Metabolic Response to High-fat Dairy in Healthy Individuals overallStatus: RECRUITING date: 2024-03-11 date: 2024-10-01 date: 2024-10-01 date: 2024-04-01 date: 2024-04-01 name: University of Aarhus class: OTHER name: Arla Foods briefSummary: The aim of the study is to investigate the effects of milk fat globule membrane (MFGM) content and intactness on postprandial metabolic response to a high-fat meal in humans.
The investigators hypothesize that MFGM content and intactness alters the postprandial lipid profile and substrate metabolism in healthy individuals after consumption of a high-fat meal. conditions: Postprandial Lipid Metabolism studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: A randomized, double-blinded, controlled, crossover trial primaryPurpose: BASIC_SCIENCE masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 12 type: ESTIMATED name: Sandwich with butter-like dairy product (40g milk fat) with intact MFGM. One sandwich for breakfast and one sandwich for lunch. name: Sandwich with butter-like dairy product (40g milk fat) with disrupted MFGM. One sandwich for breakfast and one sandwich for lunch. name: Sandwich with butter-like dairy product (40g milk fat) without MFGM. One sandwich for breakfast and one sandwich for lunch. measure: Difference in postprandial triglycerides measured as area under the curve (AUC). measure: Difference in concentration of GLP-1 measure: Difference in concentration of Ghrelin measure: Difference in concentration of LEAP2 measure: Difference in concentration of FFA measure: Difference in concentration of Insulin measure: Difference in concentration of glucagon measure: Difference in concentration of cholesterol (total, LDL and HDL) measure: Difference in concentration of GIP measure: Difference in concentration of CCK measure: Difference in concentration concentration of Gastrin measure: Difference in concentration concentration of GDF15 measure: Difference in concentration of LPS-BP (Lipopolysaccharide Binding Protein) measure: Difference in concentration concentration of Cytokines measure: Difference in concentration of apoB48 measure: Difference in concentration of apoB100 measure: Difference in glucose concentration measure: Difference in appetite sensation measure: Difference in gastric emptying rate measure: Ad libitum meal test measure: Metabolic rate measure: Substrate metabolism sex: ALL minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: Steno Diabetes Center Aarhus, Aarhus University Hospital status: RECRUITING city: Aarhus zip: 8200 country: Denmark name: Jens H Voigt, MD role: CONTACT phone: +4526395294 email: Jens.voigt@clin.au.dk name: Esben H Søndergaard, MD, PhD role: CONTACT phone: +4528730943 email: Esben.sondergaard@clin.au.dk lat: 56.15674 lon: 10.21076 hasResults: False
<\|newrecord\|> nctId: NCT06340399 id: 202312117RINE briefTitle: BCAA in Patients Undergoing Gastric Cancer Surgery overallStatus: NOT_YET_RECRUITING date: 2024-03-28 date: 2029-12-31 date: 2030-12-31 date: 2024-04-01 date: 2024-04-01 name: National Taiwan University Hospital class: OTHER briefSummary: Older patients undergoing gastric cancer resection, at higher risk due to insufficient preoperative muscle mass, are more susceptible to SRML under surgical stress. This not only affects limb muscles but also impacts swallowing muscles, contributing to increased postoperative complications and mortality rates. Enhanced Recovery After Surgery (ERAS) has emerged as a multidisciplinary approach to facilitate postoperative recovery. This study aims to optimize oral nutrition under the ERAS model to observe its impact on SRML. BCAA is essential for skeletal muscles. However, there is limited research on the oral BCAA, whether before or after surgery, concerning SRML and its associated complications. The study entails an 18-month randomized controlled trial with 200 participants. One hundred individuals will take BCAA daily 5 to 14 days before surgery. After surgery, they can progress to a clear liquid diet around postoperative day five while continuing BCAA until 30 days postoperatively. The other one hundred participants will not receive BCAA. The study aims to investigate whether oral BCAA can reduce SRML, muscle loss, and decrease swallowing muscle strength, with observations on postoperative complications and outcomes within one year. conditions: Perioeprative Muscle Loss studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: patients receiving BCAA primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: this is a open label use study whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 200 type: ESTIMATED name: BCAA name: patient not administered BCAA measure: the occurrence of surgical related muscle loss sex: ALL minimumAge: 20 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06340386 id: IEO 1365 briefTitle: Italian Validation of a Tool for Assessing Sexual Function After Breast Cancer, FSFI-BC overallStatus: RECRUITING date: 2020-10-19 date: 2024-12-31 date: 2024-12-31 date: 2024-04-01 date: 2024-04-01 name: European Institute of Oncology class: OTHER briefSummary: This is a validation study of the italian language for the Female Sexual Function Index-Breast Cancer questionnaire.
The validation of the instrument in Italian will allow the identification of possible issues related to sexual health and enable the provision of adequate medical and psychosexual counseling to these patients, both in clinical practice and in research studies. conditions: Breast Cancer studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 600 type: ESTIMATED measure: Validation of the italian translation of Female Sexual Function Index-Breast Cancer questionnaire sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: European Institute of Oncology status: RECRUITING city: Milan country: Italy name: Gabriella Pravettoni role: CONTACT lat: 45.46427 lon: 9.18951 hasResults: False
<\|newrecord\|> nctId: NCT06340373 id: NICVD/ 2023/ 32 id: NICVD /Ethical/ 2023/ 32 type: OTHER domain: National Institute of Cardiovascular Diseases(NICVD) briefTitle: Clinical and Angiographic Outcomes of Post-drug-coated Balloon Angioplasty in Native Coronary Lesions overallStatus: RECRUITING date: 2024-01-01 date: 2024-12-31 date: 2025-06-30 date: 2024-04-01 date: 2024-04-03 name: National Institute of Cardiovascular Diseases, Bangladesh class: OTHER briefSummary: The progression of cardiac revascularization techniques, starting with standard balloon angioplasty (POBA) and progressing to the creation of drug-coated balloons (DCB) and drug-eluting stents (DES). The study's justification is presented, with a focus on the significance of comprehending the clinical and angiographic outcomes of DCB angioplasty, especially when considering the Bangladeshi population.
This study's main goal is to observe the clinical and angiographic outcomes of drug-coated balloon angioplasty after native coronary lesions that have been successfully revascularized. A few specific goals are to evaluate angiographic results (like percentage diameter stenosis, vascular remodelling, restenosis, and thrombosis) after DCB angioplasty and to assess clinical outcomes (like worsening angina, target vessel MI, ischemia-driven TLR, and cardiac mortality).
This observational study will take place from January to December 2024 at the Department of Cardiology, National Institute of Cardiovascular Diseases. The study population will be individuals who had successful revascularization of native coronary lesions with DCB angioplasty six months before. The study includes non-randomized purposive sampling, and the sample size will be determined by drawing on previous studies.
Every patient will receive a thorough clinical assessment that includes a history, physical examination, electrocardiogram, and biochemical testing. The data will be analysed in accordance with the assessment of angiographic outcomes by follow-up angiography.
The purpose of this study is to give useful insights into the clinical and angiographic results of DCB angioplasty in Bangladeshi patients with native coronary lesions, including the growing body of knowledge on the efficacy and safety of this therapeutic strategy in specific populations. conditions: Coronary Artery Disease studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 303 type: ESTIMATED name: DCB Angioplasty measure: CCS (Canadian Cardiovascular Society) Class of Worsening angina of each participant measure: Number of participants with target vessel Myocardial infarction measure: Ischemia-driven Target lesion revascularization (TLR) each participant measure: Occurrence of Cardiac death in the participants measure: Site of the lesion measure: Lesion Length measure: % of Stenosis measure: Thrombolysis in Myocardial Infarction (TIMI) Flow measure: Pre dilatation - Balloon Type sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: National Institute of CardioVascular Diseases status: RECRUITING city: Dhaka zip: 1207 country: Bangladesh name: Sayeedur Rahman Khan, MD role: CONTACT phone: +8801711850078 email: dr.rumibd@gmail.com name: Md Zahid Hasan, MD role: CONTACT phone: +8801723-218955 email: zhasan390@gmail.com name: Prof. Mohsin Ahmed, MD role: PRINCIPAL_INVESTIGATOR name: Dr. Sayeedur Rahman Khan, MD role: SUB_INVESTIGATOR name: Dr. Md Zahid Hasan, MD role: SUB_INVESTIGATOR name: Dr. Shariful Islam, MD role: SUB_INVESTIGATOR name: Dr. CM Kudrat E Khuda, MD role: SUB_INVESTIGATOR name: Dr. Mohammad Arifur Rahman, MD role: SUB_INVESTIGATOR name: Dr. Md Matiur Rahman, MD role: SUB_INVESTIGATOR name: Dr. SA Shiblee, MPH role: SUB_INVESTIGATOR name: Md. Habibur Rahman, M.Sc role: SUB_INVESTIGATOR lat: 23.7104 lon: 90.40744 hasResults: False
<\|newrecord\|> nctId: NCT06340360 id: 23-358-06 id: 2023-509981-39 type: EUDRACT_NUMBER briefTitle: A Phase 2b Study to Evaluate Rezpegaldesleukin (Rezpeg) in the Treatment of Severe to Very Severe Alopecia Areata in Adult Patients (Rezolve AA) overallStatus: RECRUITING date: 2024-03-27 date: 2025-08-31 date: 2026-02 date: 2024-04-01 date: 2024-04-03 name: Nektar Therapeutics class: INDUSTRY briefSummary: This is an interventional, randomized, double blind, parallel group, placebo-controlled, Phase 2b, 3-arm study to assess the effect of pegylated-recombinant-human interleukin-2 (rezpegaldesleukin) in adult participants with severe to very severe alopecia areata.
The estimated duration includes a screening period of up to 35 days, a 36-week treatment period, and a 24-week follow-up period. The maximum study duration is approximately 65 weeks for all participants. conditions: Alopecia Areata studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Patients will be randomized to 1 of 3 groups (low dose, high dose, or placebo). primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 110 type: ESTIMATED name: Rezpegaldesleukin name: Placebo measure: Percent change from baseline in Severity of Alopecia Tool (SALT) score at Week 36 measure: Percent change from baseline in SALT score measure: Proportion of patients achieving improvement in Severity of Alopecia Tool (SALT) ≥ 50%/75%/90% measure: Proportion of patients achieving an absolute SALT score ≤ 10/20/30 sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Austin Institute for Clinical Research status: RECRUITING city: Pflugerville state: Texas zip: 786660 country: United States lat: 30.43937 lon: -97.62 hasResults: False
<\|newrecord\|> nctId: NCT06340347 id: C5351010 briefTitle: A Study to Learn How the Body Processes the Study Medicine Called Osivelotor (PF-07940367) in People With Loss of Liver Function overallStatus: NOT_YET_RECRUITING date: 2024-04-24 date: 2026-02-05 date: 2026-02-05 date: 2024-04-01 date: 2024-04-01 name: Pfizer class: INDUSTRY briefSummary: The purpose of this study is to understand how Osivelotor is processed in people with loss of liver function.
This study is seeking participants that are:
* stable loss of liver function with mild or moderate severity
* none of underlying conditions possibly affecting the study medicine being absorbed by the body
All participants will receive one amount of Osivelotor by mouth before breakfast on the first day at the study clinic. A number of blood samples will be collected to understand how Osivelotor is changed and removed from the body. Participants will also have to undergo physical examination and other tests. This will help to understand if Osivelotor is safe.
Participants will take part in the study for a maximum of 112 days. During this time, participants will have to stay onsite for 5 days. There will be 5 study visits at the study clinic. conditions: Liver Diseases studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: An open label, single dose, parallel cohort study primaryPurpose: BASIC_SCIENCE masking: NONE count: 16 type: ESTIMATED name: Osivelotor measure: Area under the whole blood and plasma concentration versus time curve (AUC) from time zero (pre-dose) to the last quantifiable concentration (AUClast) of osivelotor measure: Area under the whole blood and plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (AUCinf) of osivelotor measure: Maximum observed whole blood and plasma concentration (Cmax) of osivelotor measure: Number of Participants With Treatment-Emergent Adverse Events (AEs) measure: Number of Participants With Clinically Significant Laboratory Abnormalities measure: Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings measure: Number of Participants With Clinically Significant With Clinically Significant Vital Signs sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06340334 id: KY20240123-05 briefTitle: Efficacy and Safety of Tegoprazan Dual Therapy and Furazolidone-based Bismuth Quadruple Therapy for Helicobacter Pylori Eradication: A Prospective, Multicenter, Open-label, Randomized Controlled Clinical Study overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-12-31 date: 2024-12-31 date: 2024-04-01 date: 2024-04-01 name: Nanjing First Hospital, Nanjing Medical University class: OTHER briefSummary: To compare the efficacy and safety of Tegoprazan-amoxicillin dual therapy and bismuth quadruple therapy based on furazolidone in the treatment of Helicobacter pylori eradication, the eradication rate, patient compliance, and adverse drug reactions of H. pylori infection were compared in a multi-center clinical joint study in Jiangsu Province. conditions: Helicobacter Pylori Infection conditions: Tegoprazan conditions: Furazolidone studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 600 type: ESTIMATED name: Tegoprazan-amoxicillin dual therapy measure: Helicobacter pylori eradication rate measure: Security observations measure: Patient compliance sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06340321 id: PBRC 2023-081 briefTitle: Impact of Metabolic Flexibility on Changes in Metabolic Health acronym: METPROS overallStatus: ENROLLING_BY_INVITATION date: 2024-06 date: 2025-01 date: 2025-01 date: 2024-04-01 date: 2024-04-03 name: Pennington Biomedical Research Center class: OTHER briefSummary: Metabolic flexibility is the capacity to adapt fuel oxidation to fuel availability so that ATP synthesis can match its cellular demands. Thus, for example, increases in glucose availability after a meal would increase glucose oxidation, while increases in lipid availability during fasting would increase lipid oxidation. Enhanced metabolic flexibility has been proposed to protect humans from metabolic diseases. Nevertheless, most studies examining associations between metabolic flexibility and metabolic health outcomes have used cross-sectional designs. Whether impaired metabolic flexibility causes or results from metabolic health impairment is thus unclear.
In this study, the investigators will use the data from a study conducted approximately 16 years ago in healthy participants without obesity. Using the data already collected in that study, the metabolic flexibility of each participant will be calculated. To test the association between metabolic flexibility and the change in metabolic health, the investigators will call back all the participants for a single follow-up visit to reassess several metabolic health outcomes. Thus, the main aim of the study is to test the association between metabolic flexibility and the change in metabolic health outcomes after 16 years in humans. conditions: Obesity conditions: Metabolic Syndrome studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 88 type: ESTIMATED name: Metabolic flexibility in the fasted state name: Metabolic flexibility in euglycemic-hyperinsulinemic clamp name: Metabolic flexibility in the metabolic chamber measure: Glucose measure: Total cholesterol measure: HDL cholesterol measure: LDL cholesterol measure: Triglycerides measure: HOMA-IR measure: Blood pressure measure: Waist circumference measure: Body mass index measure: Body fat percentage sex: ALL minimumAge: 20 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Pennington Biomedical Research Center city: Baton Rouge state: Louisiana zip: 70808 country: United States lat: 30.45075 lon: -91.15455 hasResults: False
<\|newrecord\|> nctId: NCT06340308 id: PARAF 986117570 briefTitle: Clinical Study With Berberine-based Food Supplement, Artichoke Extract, Phytosterols, Fenugreek and SelectSIEVE® OptiChol acronym: PARAF overallStatus: RECRUITING date: 2023-06-07 date: 2024-03 date: 2024-05 date: 2024-04-01 date: 2024-04-01 name: University of Pavia class: OTHER name: Foundation IRCCS San Matteo Hospital briefSummary: To evaluate the effects of a nutraceutical containing Berberine-based Food Supplement, Artichoke Extract, Phytosterols, Fenugreek and SelectSIEVE® OptiChol on lipid profile conditions: Dyslipidemias studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 36 type: ESTIMATED name: Berberine-based Food Supplement, Artichoke Extract, Phytosterols, Fenugreek and SelectSIEVE® OptiChol name: Berberine-based Food Supplement, Artichoke Extract, Phytosterols, Fenugreek and SelectSIEVE® OptiChol measure: Variations of lipid profile sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Policlinico S. Matteo Foundation status: RECRUITING city: Pavia zip: 27100 country: Italy name: Giuseppe Derosa, MD, PhD role: CONTACT email: giuseppe.derosa@unipv.it name: Pamela Maffioli, MD role: CONTACT email: p.maffioli@smatteo.pv.it name: Giuseppe Derosa, MD, PhD role: PRINCIPAL_INVESTIGATOR name: Pamela Maffioli, MD role: SUB_INVESTIGATOR lat: 45.19205 lon: 9.15917 hasResults: False
<\|newrecord\|> nctId: NCT06340295 id: 2023313 briefTitle: A Multicenter, Prospective Cohort Study of Preserved Ratio Impaired Spirometry(PRISm) in a Population overallStatus: RECRUITING date: 2023-09-01 date: 2026-05-31 date: 2026-05-31 date: 2024-04-01 date: 2024-04-01 name: Peking University First Hospital class: OTHER name: Shanxi Bethune Hospital name: First Affiliated Hospital Xi'an Jiaotong University name: Tianjin Medical University General Hospital name: The First Hospital of Qinhuangdao name: Shandong Provincial Hospital name: Second Hospital of Jilin University name: People's Hospital of Xinjiang Uygur Autonomous Region name: MinDong Hospital of Ningde City briefSummary: Chronic obstructive pulmonary disease (COPD) is the most common chronic tract disease and the third leading cause of death worldwide. The treatment effect of COPD is poor, and the disease is progressive, resulting in a serious disease burden. The key reason is that early recognition is difficult and the early pathophysiological mechanism is unclear, which leads to the difficulty of early intervention.PRISm is likely to be the precursor stage of COPD, which may provide an important research object for the study of pathophysiological characteristics, inflammation and immunomodulatory mechanisms of early COPD, and may also become a new entry point for early intervention of COPD. This study attempts to establish a PRISm prospective cohort，and collects blood, EBC and urine for analysis of inflammatory factors, metabolomics, proteomics and microbiome, and performs chest HRCT to obtain imaging indicators, and conducts 3-year dynamic follow-up observation to study the evolution characteristics of pulmonary function and the incidence of COPD in the PRISm cohort. To compare the differences in imaging, inflammatory factors, metabolomics, proteomics and microbiome among the three PRISm groups, and establish a risk prediction model for progression to COPD through PRISm. It lays a foundation for understanding the characteristics of COPD at an earlier stage and exploring new early warning indicators. conditions: COPD studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 2000 type: ESTIMATED measure: The number and proportion of newly diagnosed COPD measure: The number and proportion of continuous PRISm population measure: The number and proportion of PRISm to normal population measure: Emerging diseases measure: Death and cause of death sex: ALL minimumAge: 20 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Peking University First Hospital status: RECRUITING city: Beijing state: Beijing zip: 100034 country: China name: Jiping Liao, MD. role: CONTACT phone: 13521714181 email: colorfulwing01@163.com name: Chunbo Zhang role: CONTACT phone: 13086645758 email: 2399637945@qq.com name: Jiping Liao, MD. role: PRINCIPAL_INVESTIGATOR name: Guangfa Wang, MD. role: SUB_INVESTIGATOR name: Zhe Jin, MD. role: SUB_INVESTIGATOR name: Meng Zhang role: SUB_INVESTIGATOR name: Yan Hu, MD. role: SUB_INVESTIGATOR name: Chunbo Zhang role: SUB_INVESTIGATOR name: Xueying Li role: SUB_INVESTIGATOR name: Jian Chen role: SUB_INVESTIGATOR lat: 39.9075 lon: 116.39723 facility: Peking University First Hospital status: RECRUITING city: Beijing state: Beijing zip: 100034 country: China name: Guangfa Wang, MD role: CONTACT phone: 13810644029 email: wangguangfa@hotmail.com name: Jiping Liao, MD role: CONTACT phone: 13521714181 email: colorfulwing01@163.com name: Yunxia Wang, PhD role: SUB_INVESTIGATOR name: Yijue Zhong, PhD role: SUB_INVESTIGATOR name: Chao Sun, PhD role: SUB_INVESTIGATOR lat: 39.9075 lon: 116.39723 facility: The First Hospital of Qinhuangdao status: RECRUITING city: Qinhuangdao state: Hebei country: China name: Hua Qiao, MD role: CONTACT phone: 13780358298 email: qh1202@163.com lat: 39.93167 lon: 119.58833 facility: Tianjin Medical University General Hospital status: RECRUITING city: Tianjin state: Tianjin country: China name: Lixia Dong, MD role: CONTACT phone: 13001385918 email: luckydonglixia@163.com lat: 39.14222 lon: 117.17667 facility: Shandong Provincial Hospital Affiliated to Shandong University status: RECRUITING city: Jing'an country: China name: Jian Sun, MD role: CONTACT email: docbenjaminsun@163.com facility: Shanxi Bethune Hospital status: RECRUITING city: Taiyuan country: China name: Ruiying Wang, MD role: CONTACT phone: +86 13903436432 email: wry0526@163.com lat: 37.86944 lon: 112.56028 hasResults: False
<\|newrecord\|> nctId: NCT06340282 id: MOTOMED briefTitle: Immersive Virtual Reality and Physical Exercise on Cognitive and Functional Performance in Hospitalized Older Patients acronym: MOTOMED overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-04-01 date: 2025-04-01 date: 2024-04-01 date: 2024-04-03 name: Fundacion Miguel Servet class: OTHER briefSummary: This study will be conducted in a hospital in Spain to investigate how a special intervention using immersive virtual reality technology can benefit hospitalized older adults with difficulties in their daily functionality.
The main objective of this study is to evaluate whether a cognitive stimulation intervention through immersive virtual reality, along with specific physical exercises, can improve the cognitive and physical function of hospitalized older patients. It is expected that this innovative intervention will have a positive impact on the quality of life of these patients.
Participants eligible for the study must be over 75 years old, have severe functional dependency upon hospital admission, and be willing to participate. Those with severe dementia or other terminal illnesses will be excluded.
Participants will be randomly assigned to one of four study groups: a control group without intervention and three intervention groups, including viewing Spanish landscapes through virtual reality, performing specific physical exercises, or a combination of both interventions.
At the end of the study, various aspects such as cognitive and physical function, mood, quality of life, muscle strength, and acceptance of virtual reality technology by patients will be evaluated.
This study aims to provide new insights into the care of hospitalized older adults and explore innovative ways to improve their well-being during their hospital stay conditions: Disability Physical conditions: Cognition studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This clinical randomized controlled trial will be conducted in the Acute Geriatric Unit of a tertiary hospital in Spain. A total of 212 acute patients will be enrolled according to the following criteria: age \> 75, Barthel Index \< 60, able to collaborate, expected length of stay \> 5 days, absence of clinical instability and severe dementia (GDS 7) or other end-stage disease. Patients will be randomly assigned to a control group (CG) or any of the three intervention groups (IG): IVR, ME, or IVR + ME. The IVR group will watch ad-hoc videos showing Spanish regional landscapes and villages, approximately 4 minutes per day for three consecutive days. The ME group will undergo aerobic and strength exercise for progressive training of the upper and lower limbs. The IVR + ME group will do both cognitive and physical intervention. The primary outcomes will be cognitive and physical measures at discharge. Mood, quality of life, isometric strength, and acceptance of IVR will be also assessed. primaryPurpose: PREVENTION masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 212 type: ESTIMATED name: Virtual reality name: multicomponent exercise measure: Mini-Mental State Examination (MMSE) measure: Isometric handgrip strength sex: ALL minimumAge: 75 Years stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06340269 id: PJ2308-0025 briefTitle: Feasibility Pilot Study to Evaluate the Safety and Performance of the MEX-CD1 Medical Device in ACLF acronym: MexACLF overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-03 date: 2025-03 date: 2024-04-01 date: 2024-04-03 name: Mexbrain class: INDUSTRY briefSummary: The goal of this clinical trial is to test the MEX-CD1 hemodialysis medical device in patients suffering from ACLF. The main questions it aims to answer are:
* Is the device safe when used according to the instructions for use?
* Does the device work as expected by removing the excess of free copper from the blood?
Patients will receive 3 MEX-CD1 Slow Low volume CVVHD within 1 week. conditions: Acute on Chronic Liver Failure conditions: Multiple Organ Failure studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Prospective, national, monocentric, single-arm, open label, feasibility pilot clinical trial. primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: MEX-CD1 Dialysis measure: SADE for Safety purpose measure: SAE for Safety purpose measure: Performance of MEX-CD1 measure: Change in Acute on Chronic Liver Failure (ACLF) Grade measure: Change in CLIF-C ACLF score measure: Improvement in individual organ function measure: Development of secondary infection measure: Status of ICU measure: hospital discharge measure: Mortality sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hôpital Croix Rousse, Service d'hépatologie et gastroentérologie city: Lyon state: Rhône-Alpes zip: 69317 country: France name: Céline GUICHON, MD role: CONTACT phone: +33426109351 email: celine.guichon@chu-lyon.fr name: Céline Guichon, MD role: PRINCIPAL_INVESTIGATOR lat: 45.74848 lon: 4.84669 hasResults: False
<\|newrecord\|> nctId: NCT06340256 id: IRB0000871253 briefTitle: Continuous Spinal Anesthesia Versus Epidural Anesthesia in Geriatric overallStatus: COMPLETED date: 2021-09-18 date: 2023-08-02 date: 2023-08-15 date: 2024-04-01 date: 2024-04-01 name: Assiut University class: OTHER briefSummary: 60 patients aged older than 60 years, American Society of Anesthesiologists (ASA) class II or III and scheduled for major hip surgery will be randomized, in to two groups anesthetized using continuous spinal anesthesia or using continuous epidural anesthesia. conditions: Epidural Catheter studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: SINGLE whoMasked: PARTICIPANT count: 60 type: ACTUAL name: Continuous spinal anesthesia name: Continuous epidural anesthesia measure: Hemodynamic changes measure: Patient satisfaction sex: ALL minimumAge: 60 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Al-Azhar Faculty of Medicine city: Assiut country: Egypt lat: 27.18096 lon: 31.18368 hasResults: False
<\|newrecord\|> nctId: NCT06340243 id: HODGKIN briefTitle: Risk Adapted Therapy of Hodgkin Lymphoma in Upper Egypt overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-04-01 date: 2026-04-01 date: 2024-04-01 date: 2024-04-01 name: Assiut University class: OTHER briefSummary: determine if radiotherapy could be safely omitted for early hodgkin lymphoma responder patients without compromising outcome conditions: Pediatric Hodgkin Lymphoma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 50 type: ESTIMATED name: radiotherapy measure: assess the outcome of pediatric patients with HL treated with risk- and response-adjusted therapy sex: ALL minimumAge: 1 Month maximumAge: 18 Years stdAges: CHILD stdAges: ADULT hasResults: False
<\|newrecord\|> nctId: NCT06340230 id: BC-NEO-IIT-SHR-A1811-SHR1316 briefTitle: SHR-A1811 Alone or in Combination With Adebrelimab as Neoadjuvant Treatment in ER Positive/HER2 Low Breast Cancer overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2026-02-28 date: 2031-02-28 date: 2024-04-01 date: 2024-04-01 name: Shengjing Hospital class: OTHER name: Jiangsu HengRui Medicine Co., Ltd. briefSummary: This is an open-label, phase II study evaluating the efficacy and safety of SHR-A1811 alone or in combination with Adebrelimab in Stage II-III ER Positive/HER2 Low Breast Cancer. Subjects will receive the neoadjuvant therapy of SHR-A1811 alone or in combination with Adebrelimab for six cycles, and then undergo surgery within 4 weeks after neoadjuvant therapy. Efficacy will be assessed every 2 cycles. conditions: ER Positive/HER2 Low Breast Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 93 type: ESTIMATED name: SHR-A1811 Injection + Adebrelimab Injection name: SHR-A1811 Injection + Adebrelimab Injection name: SHR-A1811 Injection measure: Total pathological complete response (tpCR: ypT0-is/ypN0) measure: Breast pathological complete response (bpCR：ypT0-is) measure: Residual cancer burden (RCB) measure: Best overall response rate (BORR) measure: Overall survival (OS) measure: Disease-free survival (DFS) measure: Event-free survival (EFS) measure: Health-related quality of life (HRQOL) (EORTC QLQ-C30) measure: Health-related quality of life (HRQOL) sex: FEMALE minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Shengjing Hospital affiliated to China Medical University city: Shenyang state: Liaoning zip: 110004 country: China name: Nan Niu, MD role: CONTACT phone: +8618940256668 email: niunannancy@163.com name: Caigang Liu, MD role: PRINCIPAL_INVESTIGATOR lat: 41.79222 lon: 123.43278 hasResults: False
<\|newrecord\|> nctId: NCT06340217 id: WMT-GDP-RCT briefTitle: Washed Microbiota Transplantation for Diabetic Gastroparesis overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2029-01 date: 2029-07 date: 2024-04-01 date: 2024-04-17 name: The Second Hospital of Nanjing Medical University class: OTHER briefSummary: This is a randomized controlled trial to explore the efficacy and safety of washed microbiota transplantation (WMT) for diabetic gastroparesis (DGP) patients. conditions: Diabetic Gastroparesis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 46 type: ESTIMATED name: washed microbiota transplantation name: placebo measure: The proportion of DGP with symptom relief after the procedure. measure: The extent of change observed in GCSI of participants; measure: The extent of change observed in Gastroparesis Core Symptom Daily Diary (GCS-DD) of participants; measure: The extent of change observed in Patient Assessment of Upper Gastrointestinal Symptom Severity Index (PAGI-SYM) of participants; measure: The extent of change observed in Patient Assessment of Upper Gastrointestinal Disorders-Quality of Life (PAGI-QoL) of participants; measure: The extent of change observed in electrogastrogram (EGG) of participants; measure: The extent of change observed in electrogastrogram (EGG) of participants; measure: The extent of change observed in gastrointestinal ultrasound (GIUS) of participants; measure: The incidence rate of adverse events; measure: The changes in gut microbiota composition and metabolites before and after treatment. sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University city: Nanjing state: Jiangsu zip: 210011 country: China lat: 32.06167 lon: 118.77778 hasResults: False
<\|newrecord\|> nctId: NCT06340204 id: PKUPH-EWS-03 briefTitle: Weekly Irinotecan Liposomes in Recurrent or Refractory Ewing Sarcoma overallStatus: RECRUITING date: 2024-03-25 date: 2026-03-25 date: 2026-12-25 date: 2024-04-01 date: 2024-04-03 name: Peking University People's Hospital class: OTHER name: Peking University Shougang Hospital name: Shandong Cancer Hospital and Institute briefSummary: The investigators explored the safety and activity of weekly irinotecan liposomes in patients with relapsed and metastatic Ewing Sarcoma. conditions: Ewing Sarcoma studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 44 type: ESTIMATED name: Irinotecan Hydrochloride Liposome Injection measure: maximum tolerated dose (MTD) measure: Objective Response Rate (ORR) measure: Progression Free Survival (PFS) sex: ALL minimumAge: 8 Years maximumAge: 40 Years stdAges: CHILD stdAges: ADULT facility: Shandong Cancer Hospital and Institute status: NOT_YET_RECRUITING city: Jina state: Shandong zip: 250117 country: China name: Dongyuan Zhu, M.D. role: CONTACT email: 405683898@qq.com facility: Peking University Shougang Hospital status: NOT_YET_RECRUITING city: Beijing zip: 100043 country: China name: Jin GU, M.D. role: CONTACT email: jingu_1999@yahoo.com lat: 39.9075 lon: 116.39723 facility: Peking University People's Hospital status: RECRUITING city: Beijin zip: 100034 country: China name: Jie Xu, M.D. role: CONTACT phone: +86 15901040835 email: xujie@pkuph.edu.cn name: Xiaodong Tang, M.D. role: PRINCIPAL_INVESTIGATOR name: Lu Xie, M.D. role: SUB_INVESTIGATOR hasResults: False

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