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<\|newrecord\|> nctId: NCT06288477 id: 2023-2 briefTitle: Clinical and Radiographic Evaluation of Vital Pulpotomy Techniques in Primary Molars Using of Premixed Bioactive Bioceramic MTA (Neo-putty) as a Novel Pulpotomy Medication Versus Formocresol overallStatus: NOT_YET_RECRUITING date: 2024-03-20 date: 2024-05-01 date: 2025-02-01 date: 2024-03-01 date: 2024-03-18 name: October University for Modern Sciences and Arts class: OTHER briefSummary: Despite the benefit of formocresol, there are toxic effects allergic reactions and local soft and hard tissue necrosis have been reported when such formaldehyde compounds were used clinically, however, the adverse effect of the clinically used of this compound are not widely reported. It has been stated that it has a side effect on the permanent successor although it results as a successful technique for the treatment of the primary teeth conditions: Vital conditions: Pulpotomy conditions: Techniques studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 44 type: ESTIMATED name: A cotton pellet moistened with full-strength FC name: Neo-Putty measure: Clinical success sex: ALL minimumAge: 4 Years maximumAge: 9 Years stdAges: CHILD hasResults: False
<\|newrecord\|> nctId: NCT06288464 id: 315656 id: 22/WM/0222 type: OTHER domain: Health Research Authority briefTitle: Enteral Feeding of Fibre to Improve Microbiota overallStatus: RECRUITING date: 2023-01-09 date: 2025-12-01 date: 2025-12-01 date: 2024-03-01 date: 2024-03-01 name: Lancashire Teaching Hospitals NHS Foundation Trust class: OTHER name: Lancaster University briefSummary: Following surgical removal of diseased bowel, patients often require a temporary redirection of bowel contents to a stoma, to allow healing prior to re-joining of the remaining bowel at a later date. Some patients may experience complications, either during or after reversal surgery, and this may be due to changes in the 'friendly' bacteria that live in our bowels. Previous research shows that the distal section of bowel that is non-functioning undergoes tissue-wasting and the 'friendly' bacteria that help our digestion die. Data shows that patients that have a reduction in their microflora are more likely to experience side effects. This study investigates a method of replenishing the microflora prior to surgery. conditions: Bowel Dysfunction conditions: Colon Disease conditions: Ileum--Diseases studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Cohort primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 15 type: ESTIMATED name: Soluble Fibre measure: Concentration of Microbiota measure: Concentration of Immune Cell Populations measure: Length of Stay measure: Rate of clinical complications sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Lancashire Teaching Hospitals NHS status: RECRUITING city: Preston state: Lancashire zip: PR2 9HT country: United Kingdom name: Kina Bennett role: CONTACT phone: (+44) 01772 522031 email: kina.bennett@lthtr.nhs.uk name: Research Access role: CONTACT email: research.access@lthtr.nhs.uk name: Arnab Bhowmick role: PRINCIPAL_INVESTIGATOR lat: 53.76282 lon: -2.70452 typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2023-02-01 uploadDate: 2024-02-23T12:17 filename: Prot_000.pdf size: 250752 hasResults: False
<\|newrecord\|> nctId: NCT06288451 id: STUDY00018021 id: 1K23DK136930-01 type: NIH link: https://reporter.nih.gov/quickSearch/1K23DK136930-01 briefTitle: DePTH: De-emphasize PTH overallStatus: RECRUITING date: 2024-03-11 date: 2027-02-28 date: 2027-02-28 date: 2024-03-01 date: 2024-03-18 name: University of Washington class: OTHER name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) briefSummary: The De-emphasize Parathyroid Hormone (DePTH) Study is a 12-month pragmatic, randomized, parallel-group, active comparator, open-label, blinded end-point study of 90 patients with incident or prevalent secondary hyperparathyroidism and kidney failure treated with in-center hemodialysis. It tests the hypothesis that low fixed-dose oral calcitriol (intervention) will have more favorable effects on a comprehensive panel of biomarkers that assesses mineral metabolism, bone turnover, and serum calcification propensity, compared with variably-dosed intravenous activated vitamin D titrated to PTH targets (usual care). conditions: Kidney Failure, Chronic conditions: Chronic Kidney Disease-Mineral and Bone Disorder studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 90 type: ESTIMATED name: Oral calcitriol with cinacalcet rescue name: IV activated vitamin D measure: Change in fibroblast growth factor-23 measure: Change in serum calcium measure: Change in serum phosphate measure: Change in serum bone-specific alkaline phosphatase measure: Change in serum parathyroid hormone measure: Change in T50 test of serum calcification propensity measure: Patient acceptability measure: Patient acceptability sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Washington status: RECRUITING city: Seattle state: Washington zip: 98104 country: United States name: Simon Hsu, MD, MS role: CONTACT phone: 206-540-5714 email: sihsu@uw.edu name: Ian H de Boer, MD, MS role: PRINCIPAL_INVESTIGATOR name: Simon Hsu, MD, MS role: PRINCIPAL_INVESTIGATOR lat: 47.60621 lon: -122.33207 hasResults: False
<\|newrecord\|> nctId: NCT06288438 id: E5012-R id: 23-2306 type: OTHER domain: COMIRB briefTitle: Multicomponent Telerehabilitation to Engage Veterans in Effective Self-Management of Complex Health Conditions overallStatus: RECRUITING date: 2024-04-01 date: 2026-11-02 date: 2028-03-31 date: 2024-03-01 date: 2024-04-08 name: VA Office of Research and Development class: FED briefSummary: Medically complex older Veterans are at greater risk for progressive declines in physical function, lower quality of life, and increasing care needs. Additionally, older Veterans experience social isolation and loneliness, and have low levels of physical activity. While the Veterans Health Administration has established programs to address rehabilitation needs, these programs tend to be diagnosis-focused, lack self-management approaches, include low-intensity rehabilitation, and typically require in-person attendance. A MultiComponent TeleRehabilitation (MCTR) program that includes high-intensity rehabilitation and self-management interventions, social support, and telehealth and technology supports may be more effective in improving and sustaining physical function for older Veterans with complex health conditions. Therefore, this project is designed to determine whether the MCTR program improves strength and physical function more effectively than traditional interventions. conditions: Multimorbidity conditions: Physical Deconditioning studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants will be randomized into 1 of 2 groups. Group 1 will receive the intervention for 24 weeks. Group 2 will receive the control condition for 24 weeks. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: The outcome assessor will be blinded to group allocation. whoMasked: OUTCOMES_ASSESSOR count: 126 type: ESTIMATED name: Motivational Interviewing Techniques name: Physical Therapy Interventions name: Education name: Health Status Updates name: Physical Therapy Consult measure: 2 Minute Step Test measure: Arm Curl Test measure: 30 Second Sit To Stand measure: Physical Activity measure: Exercise readiness to change measure: Self-efficacy for Exercise Scale measure: Self-efficacy of Managing Chronic Conditions measure: The Patient-Specific Functional Scale measure: Activity Measure for Post-Acute Care (AM-PAC) basic mobility outpatient routine short form measure: Patient-Reported Outcomes Measurement Information System (PROMIS) 29+2 Profile v2.1 (PROPr) survey measure: Patient-Reported Outcomes Measurement Information System (PROMIS) v2 social isolation short form (SF) 8a measure: Patient-Reported Outcomes Measurement Information System (PROMIS) satisfaction with participation in discretionary social activities short form (SF) 7a measure: Physical Activity and Social Support Scale measure: Geriatric Pain Measure measure: Pain Coping Inventory sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Rocky Mountain Regional VA Medical Center, Aurora, CO status: RECRUITING city: Aurora state: Colorado zip: 80045 country: United States name: Jennifer E Stevens-Lapsley, PhD role: CONTACT phone: 303-949-9304 email: Jennifer.Stevens-Lapsley@va.gov name: Michelle R Rauzi, DPT role: CONTACT phone: (208) 630-4002 email: michelle.rauzi@va.gov name: Jennifer E. Stevens-Lapsley, PhD role: PRINCIPAL_INVESTIGATOR lat: 39.72943 lon: -104.83192 hasResults: False
<\|newrecord\|> nctId: NCT06288425 id: SPACE-KIT briefTitle: Spatial Transcriptomics in Kidney Transplantation acronym: SPACE-KiT overallStatus: ENROLLING_BY_INVITATION date: 2024-04-03 date: 2030-01-01 date: 2035-01-01 date: 2024-03-01 date: 2024-04-24 name: Western Sydney Local Health District class: OTHER briefSummary: The study is an investigator-led, prospective, longitudinal, observational cohort study.
The central hypothesis for this study is that spatial data will reveal new insights to immune cell function and local interactions within the kidney tissue to better predict important clinical outcomes. Investigators aspire to establish a prospective, longitudinal cohort to improve the diagnosis and management of kidney transplant rejection using precision pathology.
By utilising new spatial technologies, the investigators aim to:
* Derive a spatially resolved transcriptomic signature of kidney transplant rejection subtypes
* Derive accurate transcriptomic signatures aligned with key cell types within the transplant kidney
* Develop refinements to histological kidney rejection diagnostic and scoring classification
* Correlate of spatial and refined biopsy scoring features to clinically important outcomes conditions: Transplant Complication conditions: Kidney Injury studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 500 type: ESTIMATED name: Non interventional measure: Kidney biopsy features measure: Kidney biopsy transcriptomic signature measure: Kidney cell type composition measure: All cause graft loss measure: Death censored graft loss (DCGL) measure: Treatment resistant rejection measure: Delayed graft function (DGF) measure: Biopsy evidence of borderline rejection measure: Biopsy proven acute rejection measure: Chronic rejection measure: Interstitial fibrosis scores (IFTA) measure: BK virus associated nephropathy measure: Kidney function measure: Albuminuria measure: Surrogate end-points measure: Donor to recipient mismatches measure: Proteinomic signature sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Westmead Hospital city: Westmead state: New South Wales zip: 2145 country: Australia lat: -33.80383 lon: 150.98768 hasResults: False
<\|newrecord\|> nctId: NCT06288412 id: NN1436-7615 id: U1111-1285-1665 type: OTHER domain: World Health Organization (WHO) id: 2023-505012-38 type: OTHER domain: European Medical Agency (EMA) briefTitle: A Study to Test How a New Long-acting Insulin Works in the Body of Patients With Type 2 Diabetes During Exercise and Prolonged Fasting overallStatus: RECRUITING date: 2024-02-26 date: 2024-11-04 date: 2024-11-04 date: 2024-03-01 date: 2024-04-02 name: Novo Nordisk A/S class: INDUSTRY briefSummary: The study will investigate the safety of once weekly insulin icodec subcutaenously (s.c.) during and after exercise and prolonged fasting in patients with type 2 diabetes (T2D). Participants will first receive insulin decludec (Tresiba®, a long-acting insulin taken once daily) for atleast one week. Afterwards participants will receive insulin icodec that will be administered once weekly at the study site (for a minimum of 7 weeks and maximum of 14 weeks). Insulin icodec is a novel long-acting insulin analogue for once-weekly administration for the treatment of type 2 diabetes. The study will last for about 16-30 weeks. Participant must not participate if participant have suspected hypersensitivity reactions to the study products or cardiovascular diseases within the last 180 days. Female participant cannot take part if she is pregnant, breast-feeding or planning to become pregnant during the study period. conditions: Diabetes Mellitus, Type 2 studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Insulin icodec name: Insulin degludec measure: Time below range, glucose less than (<) 3.0 millimoles per liter (mmol/L) (54 milligrams per deciliter [mg/dL]) within 24 hours after start of exercise (TBR3.0mmol/L,exe) measure: Time below range, glucose <3.9 mmol/L (70 mg/dL) within 24 hours after start of exercise (TBR3.9mmol/L,exe) measure: Time in range, glucose 3.9-10.0 mmol/L (70-180 mg/dL) within 24 hours after start of exercise (TIR3.9-10.0mmol/L,exe) measure: Time above range, glucose >10 mmol/L (180 mg/dL) within 24 hours after start of exercise (TAR10.0mmol/L,exe) measure: Number of clinically significant hypoglycaemic episodes during exercise (Hypoexe) measure: Amount of carbohydrate intake during exercise (CHOexe) measure: Amount of carbohydrate intake from end of standardised lunch meal until start of exercise (CHOpre-exe) measure: Amount of carbohydrate intake after stop of exercise until start of standardised dinner meal (CHOpost-exe) measure: Number of hypoglycaemic within 24 hours after start of exercise (Hypo24h,exe) measure: Number of hypoglycaemic episodes for 24 hours in reference week (43 to 67 hours after dosing) (Hypo24h,ref) measure: Time below range, glucose <3.0 mmol/L (54 mg/dL) within 18 hours after start of fasting (TBR3.0mmol/L,fast) measure: Time below range, glucose <3.9 mmol/L (70 mg/dL) within 18 hours after start of fasting (TBR3.9mmol/L,fast) measure: Time in range, glucose 3.9-10 mmol/L (70-180 mg/dL) within 18 hours after start of fasting (TIR3.9-10.0mmol/L,fast) measure: Time above range, glucose >10 mmol/L (180 mg/dL) within 18 hours after start of fasting (TAR10.0mmol/L,fast) measure: Number of clinically significant hypoglycaemic episodes during fasting (Hypofast) measure: Amount of carbohydrate administered intravenously during fasting (CHOfast) measure: Number of hypoglycaemic episodes within 18 hours after start of fasting (Hypo18h,fast) measure: Number of hypoglycaemic episodes for 18 hours in reference week (26 to 44 hours after dosing) (Hypo18h,ref) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Medical University of Graz status: RECRUITING city: Graz zip: 8010 country: Austria lat: 47.06667 lon: 15.45 hasResults: False
<\|newrecord\|> nctId: NCT06288399 id: DAS-7688 id: U1111-1292-7248 type: OTHER domain: World Health Organization (WHO) briefTitle: Prevalence and Economic Burden of Obesity-related Comorbidities in the Gulf Region: A Retrospective, Observational Study overallStatus: ENROLLING_BY_INVITATION date: 2023-12-21 date: 2024-06-30 date: 2024-06-30 date: 2024-03-01 date: 2024-04-09 name: Novo Nordisk A/S class: INDUSTRY briefSummary: The aim of this study is to assess the annual prevalence of ORCs among adult people with obesity in the real-world clinical setting across the Gulf region. In addition, the study will describe the annual HCRU and associated costs of obesity and ORCs, describe the demographics and clinical characteristics of adult people with obesity, as well as estimate the annual incidence and point prevalence of the ORCs among adult people with obesity. conditions: Obesity studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 1322 type: ESTIMATED name: No treatment given measure: Proportion of Obesity Related Comorbidities (ORC, existing/newly diagnosed) among adult people with obesity (BMI above or equal to 30 kg/m2) over a period of 12 months across the Gulf region in primary and secondary hospitals as well as obesity clinics sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Farwaniya Hospital city: Farwaniya zip: 85000 country: Kuwait facility: Al-Adan Hospital city: Hadiya zip: 52700 country: Kuwait facility: Al-Amiri Hospital city: Kuwait City zip: 13001 country: Kuwait lat: 29.36972 lon: 47.97833 facility: Novo Nordisk Investigational Site city: Kuwait zip: 12030 country: Kuwait lat: 29.36972 lon: 47.97833 facility: National Diabetes and Endocrine Center city: Muscat zip: 113 country: Oman lat: 23.58413 lon: 58.40778 facility: Samail Polyclinic city: Samail zip: 620 country: Oman lat: 23.3 lon: 57.98333 facility: Hamad General Hospital city: Doha zip: 122104 country: Qatar lat: 25.28545 lon: 51.53096 facility: PHCC city: Doha zip: 122104 country: Qatar lat: 25.28545 lon: 51.53096 hasResults: False
<\|newrecord\|> nctId: NCT06288386 id: 2024-ATTACHMENTS briefTitle: Influence of Different Nanohybrid Flowable Composite Resin on Shear Bond Strength and Dimensional Changes of Invisalign Attachments After 6 Months of Brushing overallStatus: ENROLLING_BY_INVITATION date: 2024-03-04 date: 2025-02 date: 2025-02 date: 2024-03-01 date: 2024-03-15 name: University of Pavia class: OTHER briefSummary: The present study will be a single-center, split-mouth, randomized controlled clinical trial. Patients undergoing orthodontic treatment with Invisalign aligners will be enrolled after signing the informed consent. Two different flowable composite resins will be evaluated for the performing of attachments using a split-mouth design:
* group A: Filtek Supreme Flow (3M Unitek, Monrovia, Calif)
* group B: Grandioso Heavy Flow (VOCO GmbH, Cuxhaven Germany)
Digital impressions with iTero intraoral scanner will be performed; digital impressions will be performed after 3 months (T1) and 6 months (T2) from the baseline.
Digital scans will be used to assess any changes in shape and volume of the attachments per each different time frame. Each tooth will be separated from the others and superimpositions of the single tooth will be performed with ZEISS Inspect software.
After attachments placement, the clinicians will be asked to answer, on a scale from 1 to 10, to this questionnaire's questions about the two different flowable composites; each question is repeated for each composite resin.
Type of brushing (with manual or electric toothbrush) and hand of brushing will be recorded. conditions: Malocclusion studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Split-mouth design primaryPurpose: BASIC_SCIENCE masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 20 type: ESTIMATED name: GrandioSO Heavy Flow name: Filtek Z350XT Flowable measure: Changes in the volume of attachments measure: Attachments failure rate measure: Type of brushing measure: Change in questionnaire's answers measure: Hand of brushing sex: ALL minimumAge: 14 Years maximumAge: 70 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia city: Pavia state: Lombardy zip: 27100 country: Italy lat: 45.19205 lon: 9.15917 hasResults: False
<\|newrecord\|> nctId: NCT06288373 id: NACI-CERV-003 briefTitle: Neoadjuvant Chemoimmunotherapy Versus Concurrent Chemoradiotherapy for LACC overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2031-03-01 date: 2031-03-01 date: 2024-03-01 date: 2024-03-01 name: Tongji Hospital class: OTHER name: Southwest Hospital, China name: Women Hospital, School of Medicine, Zhejiang University name: Anhui Provincial Cancer Hospital name: Sichuan Cancer Hospital and Research Institute name: Qilu Hospital of Shandong University name: Beijing Friendship Hospital name: Tianjin Medical University General Hospital name: West China Second University Hospital name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University name: Xiangya Hospital of Central South University name: Gansu Provincial Maternal and Child Health Care Hospital name: Zhejiang Cancer Hospital name: Shengjing Hospital briefSummary: It is a prospective, open-label, randomized, controlled phase II/III clinical trial in which patients with PD-L1-positive FIGO stage IB3, IIA2 and IIB（tumors \>4 cm in diameter）will be enrolled and randomly divided into the neoadjuvant chemoimmunotherapy plus surgery group and the CCRT group. conditions: Cervical Cancer conditions: Locally Advanced Cervical Cancer conditions: Concurrent Chemoradiotherapy conditions: Neoadjuvant Chemoimmunotherapy studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 440 type: ESTIMATED name: Camrelizumab name: Cisplatin name: Nab paclitaxel name: Radical surgery name: external beam radiation therapy (EBRT) + brachytherapy name: Cisplatin measure: Progression-free survival, PFS measure: Objective Response Rate, ORR measure: Overall survival, OS measure: Proportion of patients undergoing radical surgery measure: Pathologic Complete Response measure: The surgical complication rate measure: Safety and toleraty measure: Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Physical Function Score measure: Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Symptom Specific Scale for Cervical Cancer (EORTC QLQ-CX24) Score sex: FEMALE minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology city: Wuhan state: Hubei zip: 430030 country: China name: Kezhen Li role: CONTACT phone: 086-027-8362 email: tjkeke@126.com name: Jing Chen role: CONTACT phone: 086-027-8362 email: chenjing3223@126.com name: Kezhen Li role: PRINCIPAL_INVESTIGATOR name: Gang Chen role: PRINCIPAL_INVESTIGATOR lat: 30.58333 lon: 114.26667 hasResults: False
<\|newrecord\|> nctId: NCT06288360 id: NACI-CERV-002 briefTitle: Neoadjuvant Immunochemotherapy in PD-L1-negative LACC overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2025-12-31 date: 2030-12-12 date: 2024-03-01 date: 2024-03-01 name: Tongji Hospital class: OTHER name: Southwest Hospital, China name: Women Hospital, School of Medicine, Zhejiang University name: Anhui Provincial Cancer Hospital name: Sichuan Cancer Hospital and Research Institute name: Gansu Provincial Maternal and Child Health Care Hospital name: Beijing Friendship Hospital name: Tianjin Medical University General Hospital name: Xiangya Hospital of Central South University name: West China Second University Hospital name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University name: Zhejiang Cancer Hospital name: Shengjing Hospital name: Qilu Hospital of Shandong University briefSummary: This is a multicenter, prospective, single-arm, phase 2 clinical trial designed to evaluate the therapeutic efficacy of the NACI (neoadjuvant chemotherapy plus Camrelizumab) for PD-L1-negative locally advanced cervical cancer. conditions: Cervical Cancer conditions: Locally Advanced Cervical Cancer conditions: PD-L1 Negative conditions: Neoadjuvant Chemoimmunotherapy studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: Camrelizumab name: Paclitaxel-albumin name: Cisplatin name: radical surgery measure: Pathologic complete response measure: Surgical Complications measure: Objective response rate measure: Positive surgical margin rate measure: event-free survival measure: overall survival measure: adverse event sex: FEMALE minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology city: Wuhan state: Hubei zip: 430030 country: China name: Jing Chen role: CONTACT phone: 086-027-8362 email: chenjing3223@126.com name: Kezhen Li role: PRINCIPAL_INVESTIGATOR name: Gang Chen role: PRINCIPAL_INVESTIGATOR lat: 30.58333 lon: 114.26667 hasResults: False
<\|newrecord\|> nctId: NCT06288347 id: 216099 briefTitle: Study of the Efficacy of GGON: a Cognitive Training App for Orthorexia Nervosa. overallStatus: NOT_YET_RECRUITING date: 2024-05-02 date: 2024-06-17 date: 2024-06-17 date: 2024-03-01 date: 2024-03-15 name: University of Valencia class: OTHER briefSummary: The aim of the present study is to evaluate the efficacy of GGON to decrease the maladaptive beliefs associated with orthorexia nervosa (ON) in non-clinical adult population. Specifically, a randomized controlled trial with crossover assignment design and two groups (experimental and control) will be carried out in adults aged 18-65 years to assess the changes pre and post use the app. It's expected that after the use of the GGON app for 15 days are, at the primary level: decrease in the degree of ascription to dysfunctional beliefs associated with ON; and at the secondary level: decrease in orthorexia nervosa symptomatology, in eating symptomatology and in obsessive beliefs; increase in self-esteem; and no changes in drepessive symptomatology. These results are also expected to be maintained in subsequent follow-ups, at 15 days and a month after to finish the app in experimental group, and 15 days after to finish the app in control group. conditions: Orthorexia Nervosa studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: All participants were requested to complete web-based assessment, with questionnaires relating to maladaptive beliefs associated with ON, ortorexia, eating and depressive symptomatology, obsessive belifs and self-esteem at baseline (T1).
The experimental group started using the app for 15 days, and later completed the following assessment (T2). The control group also completed the T2 in the same date but started to use the app after this second assessment.15 days and one month later, both groups completed T3 and T4. primaryPurpose: PREVENTION masking: SINGLE whoMasked: PARTICIPANT count: 100 type: ESTIMATED name: GGON mobile app. measure: Change in the degree of ascription to dysfunctional beliefs associated with Orthorexia Nervosa measure: Change in Orthorexia symptomatology measure: Change in eating symptomatology measure: Change in self-esteem. measure: Change in emotional symptomatology measure: Change in obsessive beliefs sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Valencia city: Valencia zip: 46010 country: Spain lat: 39.46975 lon: -0.37739 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2022-04-18 uploadDate: 2024-03-11T04:30 filename: ICF_000.pdf size: 79708 hasResults: False
<\|newrecord\|> nctId: NCT06288334 id: PUTH PD_V 1.2 briefTitle: Exploration of the Optimal Dosage of Cetirizine in the Treatment of Allergic Diseases in Chinese Children overallStatus: RECRUITING date: 2020-08-06 date: 2024-03-31 date: 2024-05-31 date: 2024-03-01 date: 2024-03-01 name: Peking University Third Hospital class: OTHER briefSummary: To obtain the pharmacokinetics of cetirizine in Chinese children with allergic disease. conditions: Allergic Disease conditions: Children studyType: INTERVENTIONAL phases: PHASE4 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: BASIC_SCIENCE masking: NONE count: 80 type: ESTIMATED name: 1-3 Cetirizine Pharmacokinetic samples measure: Plasma concentration sex: ALL minimumAge: 6 Months maximumAge: 16 Years stdAges: CHILD facility: Peking University Third Hospital status: RECRUITING city: Beijing state: Beijing zip: 100191 country: China name: Yafen Li role: CONTACT phone: 18222566785 email: liyafen314159@163.com name: Wei Zhou role: PRINCIPAL_INVESTIGATOR name: Wei Liu role: PRINCIPAL_INVESTIGATOR name: Dongyang Liu role: PRINCIPAL_INVESTIGATOR lat: 39.9075 lon: 116.39723 hasResults: False
<\|newrecord\|> nctId: NCT06288321 id: UW22221 briefTitle: A Study Investigating Whether Low Dose Eyedrops for Pupil Dilation is as Effective and Safe as Standard Dose Eyedrops in Examination for Retinopathy of Prematurity. overallStatus: COMPLETED date: 2022-08-10 date: 2023-03-22 date: 2023-03-22 date: 2024-03-01 date: 2024-03-01 name: The University of Hong Kong class: OTHER briefSummary: A prospective, randomized controlled study was conducted from August, 2022 to March, 2023 in the neonatal intensive care unit in Queen Mary Hospital, Hong Kong. The aim of this study was to determine whether microdrops Mydrin-P demonstrates similar efficacy as standard Mydrin -P eyedrops applied to neonates undergoing retinopathy of prematurity (ROP) screening exams, also to ascertain the optimal time for eye examination after administration of mydriatics and assess whether the cardiovascular, respiratory and gastrointestinal adverse effects differ between microdrops and standard dose Mydrin-P.
Preterm infants were randomized to receive either the standard Mydrin-P eyedrops or the mydriatic microdrops which contained around one-third of the standard Mydrin-P dosage. The primary outcome measured whether a successful ROP examination was conducted. Secondary outcomes included pupil diameters at baselines, 30 minutes, 60 minutes, 120 minutes after eyedrops instillation and at the time of ROP exam as well as adverse effects followed by the mydriatics administration.
A total of 18 patients were enrolled in this study with total 46 episodes of ROP recorded. All episodes with microdrops instillation led to successful ROP exams. There was no statistically significant difference between standard eyedrops and microdrops in determining the success of ROP exam (p=0.233). Mean pupil diameter did not differ between the microdrops and standard eyedrops group. At the time of ROP exam, the mean pupil diameter was 5.47mm in the standard eyedrops group and 5.73mm in the microdrops group. The optimal time for ROP exam was 60 minutes to 120 minutes after first dose of mydriatic. Also there was no difference in the occurrence of systemic side effects when compared to standard Mydrin P drops.
Hence the study concluded that microdrops have similar efficacy and safety profile compared to standard Mydrin-P eyedrops. conditions: Retinopathy of Prematurity studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 18 type: ACTUAL name: Microdrop Mydrin-P name: Standard Mydrin-P measure: Successfulness of a ROP exam measure: Pupil diameters measure: Heart rate measure: Blood pressure measure: Oxygen saturation measure: Oxygen requirement measure: Episodes of vomiting measure: Volume of gastric residuals measure: Episodes of apnoea measure: Episodes of periorbital blanching sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Paediatrics and Adolescent Medicine, Queen Mary Hospital city: Hong Kong country: Hong Kong lat: 22.27832 lon: 114.17469 typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2022-07-14 uploadDate: 2024-02-18T04:50 filename: Prot_000.pdf size: 94463 hasResults: False
<\|newrecord\|> nctId: NCT06288308 id: FAR in lupus nephritis (LN) briefTitle: Fibrinogen to Albumin Ratio (FAR) as a Predictive Biomarker for Lupus Nephritis (LN) overallStatus: NOT_YET_RECRUITING date: 2024-03-20 date: 2024-11 date: 2024-12 date: 2024-03-01 date: 2024-03-01 name: Assiut University class: OTHER briefSummary: Fibrinogen to Albumin ratio as a predictive biomarker for lupus nephritis (LN) conditions: Lupus Nephritis studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 90 type: ESTIMATED name: fibronigin to albumin ratio measure: Fibrinogen to Albumin ratio as a predictive biomarker for lupus nephritis (LN) sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT hasResults: False
<\|newrecord\|> nctId: NCT06288295 id: Etude SCORDOM briefTitle: Retrospective Study on Data Aiming to Establish a Prediction Score for Return Home at the Time of Admission to a Multidisciplinary Medical Department (SCORDOM acronym: SCORDOM overallStatus: COMPLETED date: 2021-10-01 date: 2023-02-28 date: 2023-02-28 date: 2024-03-01 date: 2024-03-01 name: Elsan class: OTHER briefSummary: The goal of this observational study is to define clinical, biological and socio-cultural criteria, from the very first days of hospitalization on the multidisciplinary medicine department, to guide the patient's discharge from hospital (return to home when discharged from hospital).
The data collected will be those contained in the medical records of patients over 60 years of age who were admitted to the multidisciplinary medical department between October 2021 and February 2022 and between October 2022 and February 2023.
This study also aims at developing and validating a predictive score of orientation at the end of hospitalisation.
Participants are patients previously hospitalized. They will be informed about the study by post and will be able to object to the use of his or her data. conditions: Continuity of Patient Care studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 600 type: ACTUAL measure: Number of patients with a return to home after hospitalization and with similar clinical parameters, similar age category, similar pathology and similar biological parameters measure: Number of patients with a return to home after hospitalization and with similar clinical parameters, similar age category, similar pathology and similar biological parameters sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hôpital Privé Nancy Lorraine city: Nancy zip: 54000 country: France lat: 48.68439 lon: 6.18496 hasResults: False
<\|newrecord\|> nctId: NCT06288282 id: STUDY-23-01287 briefTitle: Behavioral and Cognitive Predictors of Persistent Pain and Opioid Misuse in Chronic Pain overallStatus: RECRUITING date: 2023-12-20 date: 2024-12-20 date: 2024-12-20 date: 2024-03-01 date: 2024-03-01 name: Icahn School of Medicine at Mount Sinai class: OTHER briefSummary: Chronic lower back pain (CLBP) affects approximately 20% of the global population. The study objective is to determine if impulsivity, inhibitory control, drug choice, and/or cognitive distortions predict opioid misuse and disability in patients with chronic pain. This is a prospective consented cross-sectional study characterizing behavioral and cognitive phenotypes using both patient-reported survey measures and cognitive testing. Outcome measures include correlations between impulsivity measures, opioid drug choice responses and cognitive distortion scores, and risk for opioid misuse (Primary outcomes: COMM scores, SOAPPR scores). Secondary outcomes is BPI measurement. A Certificate of Confidentiality will provide additional protections for participants. conditions: Chronic Back Pain studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 130 type: ESTIMATED name: No Intervention measure: Screener and Opioid Assessment for patients with pain revised (SOAPPR) measure: Current Opioid misuse measure (COMM) surveys measure: Pain Intensity with Brief Pain inventory (BPI) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mount Sinai Pain management centers status: RECRUITING city: New York state: New York zip: 10029 country: United States lat: 40.71427 lon: -74.00597 hasResults: False
<\|newrecord\|> nctId: NCT06288269 id: PhrapokklaoHospital briefTitle: Factors of Control Hypertension or Type 2 Diabetes on the Severity of Stroke and Survival Rates Within 1 Year in Trat overallStatus: COMPLETED date: 2023-11-01 date: 2023-12-30 date: 2024-01-15 date: 2024-03-01 date: 2024-03-07 name: Phrapokklao Hospital,Thailand class: OTHER briefSummary: The purpose of this study was to study factors for controlling hypertension or type 2 diabetes before stroke diagnosis on the severity level when a stroke occurs, NIHSS, and survival rate after having a stroke in 1 year in Trat Province The research hypothesis was patients with hypertension or type 2 diabetes who are well-controlled Will have a lower NIHSS score than the group whose disease is not well-controlled. and patients with hypertension or type 2 diabetes that is well controlled There will be a higher survival rate for patients diagnosed with cerebrovascular disease within 1 year than those whose disease cannot be controlled. conditions: Stroke conditions: Hypertension conditions: Type2diabetes studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 291 type: ACTUAL name: Severity of Stroke and 1 year survival measure: Stroke severity was assessed using the National Institute of Health Stroke Scale (Clinical Mild NIHSS = 0-4 and Clinical Moderate to severe NIHSS = 5-42) measure: 1 year survival death sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Trat Provincial Public Health Office city: Trat zip: 23000 country: Thailand lat: 12.24364 lon: 102.51514 hasResults: False
<\|newrecord\|> nctId: NCT06288256 id: STUDY-22-01390 briefTitle: Neurocognitive and Genomic Predictors of Persistent Pain and Opioid Misuse After Spine Surgery overallStatus: ACTIVE_NOT_RECRUITING date: 2023-03-01 date: 2024-06 date: 2024-06 date: 2024-03-01 date: 2024-03-01 name: Icahn School of Medicine at Mount Sinai class: OTHER briefSummary: Having spine surgery and recovery is a vulnerable period when opioid naive patients may transition into long-term use of opioids, and when previously opioid tolerant patients may be at risk to continue towards long-term opioid use and dependence. However, little is known about risk for developing opioid misuse, taking opioids differently than indicated or prescribed, and later OUD. This study addresses the question of whether behavior, cognitive features, and genomic markers can predict misuse of opioids, persistent pain and disability in individuals after spine surgery.
To determine if impulsivity, inhibitory control, drug choice, and/or cognitive distortions predict opioid misuse and disability in spine surgery patients with differential gene expression.
This is a prospective observational longitudinal study characterizing behavioral phenotypes in adults undergoing spine surgery using both patient-reported survey measures, cognitive testing and blood sampling. Outcome measures include correlations between impulsivity measures, opioid drug choice responses and cognitive distortion scores, and opioid misuse with spine related disability, and gene expression counts. conditions: Lumbar Spine Pathology conditions: Elective Spine Surgery studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 60 type: ESTIMATED name: No Intervention measure: Current Opioid Misuse Measure (COMM) Score measure: Numerical Rating Scale (NRS) Score sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mount Sinai Spine Center city: New York state: New York zip: 10029 country: United States lat: 40.71427 lon: -74.00597 hasResults: False
<\|newrecord\|> nctId: NCT06288243 id: Samatya briefTitle: Functionality, Cognition And Swallowing Skills In Patients With AcuteSTROKE overallStatus: COMPLETED date: 2018-12-01 date: 2019-05-28 date: 2019-05-29 date: 2024-03-01 date: 2024-03-01 name: Medipol University class: OTHER briefSummary: Aim: Studies in which the results of the screening test evaluating swallowing skills in acute stroke patients are evaluated together with other components that may affect swallowing function are limited. The aim of this study is to determine which factors are associated with swallowing abilities in patients with acute stroke, including lesion location, cognitive level, clinical features, risk factors for stroke, and level of functionality.
Methods: The 97 acute stroke patients included in the study were grouped in terms of lesion type, affected side, and risk factors for stroke. Turkish MMASA (TR-MMASA) was used to evaluate the swallowing ability of the patients. Additionally, Standardized Mini Mental Test (SMMT) and Modified Rankin Scale (MRS) were applied to evaluate cognition level and functionality, respectively. conditions: Stroke, Acute conditions: Swallowing Disorder conditions: Cognitive Impairment conditions: Stroke conditions: Movement Disorders conditions: Dysphagia studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: CROSS_SECTIONAL count: 97 type: ACTUAL name: Clinician-observed assessment tests measure: The Correlation Between Swallowing Skills and Cognitive Status measure: The Correlation Between Swallowing Skills and Functionality measure: The relationship between stroke risk factors and swallowing skills measure: The relationship between demographic informations and swallowing skills sex: ALL minimumAge: 45 Years maximumAge: 92 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Medipol University city: Istanbul country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False
<\|newrecord\|> nctId: NCT06288230 id: LT01-101 briefTitle: An Open Label Study of Gene Therapy Product in Spinal Muscular Atrophy Patients overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2027-03-01 date: 2027-03-01 date: 2024-03-01 date: 2024-03-01 name: Lantu Biopharma class: INDUSTRY briefSummary: This is an interventional study to evaluate safety and efficacy of AAV-hSMN1 in spinal muscular atrophy patients. conditions: Spinal Muscular Atrophy studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 6 type: ESTIMATED name: vesemnogene lantuparvovec measure: Numbers of participants with adverse events (AEs), serious adverse events (SAEs) measure: Change from baseline in hours of daily ventilation support and motor function measure: Change from baseline in ambulatory function measure: Change from baseline in Hammersmith Functional Motor Scale - Expanded (HFMSE) sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06288217 id: NS-CIP-001 briefTitle: Non-invasive Trigeminal and Vagus Nerve Stimulation for Stroke Subjects With Chronic Upper Extremity Deficits overallStatus: RECRUITING date: 2024-03-05 date: 2024-12 date: 2024-12 date: 2024-03-01 date: 2024-03-12 name: NeuraStasis, Inc class: INDUSTRY briefSummary: This is a single-center, pilot study of up to 25 subjects with residual upper extremity deficits at least six months after an ischemic stroke. The purpose of the study is to evaluate the initial clinical safety, device functionality, and treatment effect of non-invasive electrical stimulation of the trigeminal and/or vagus nerves (nTVNS) using the NeuraStasis Stimulator System adjunctive to rehabilitation. Subjects will either receive the intervention or control-sham stimulation. The study will inform the design and implementation of a pivotal study. conditions: Stroke, Ischemic conditions: Upper Extremity Paresis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 25 type: ESTIMATED name: NeuraStasis Stimulator System (Non-Invasive Trigeminal and Vagus Nerve Stimulation) name: Upper Limb Rehabilitation name: Sham Stimulation measure: Fugl-Meyer Assessment, Upper Limb (FMA-UE) Average Change measure: Action Research Arm Test (ARAT) Average Change measure: Fugl-Meyer Assessment, Upper Limb (FMA-UE) Response % measure: Proportion of subjects completing all pre-specified treatment doses measure: Subject Questionnaire on Device Usage measure: Therapist Questionnaire on Device Usage measure: Serious adverse device effects (SADE) rate at 24 hours post-therapy session measure: Stroke impact scale (SIS) Summative Score Average Change measure: Analysis of the number of stimulations per therapy session sex: ALL minimumAge: 40 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The University of Texas Health Science Center at Houston status: RECRUITING city: Houston state: Texas zip: 77030 country: United States name: Sean Savitz, MD role: CONTACT phone: 713-500-7083 email: Sean.I.Savitz@uth.tmc.edu name: Emily Stevens, OTR role: CONTACT phone: 713-500-7914 email: emily.a.stevens@uth.tmc.edu lat: 29.76328 lon: -95.36327 hasResults: False
<\|newrecord\|> nctId: NCT06288204 id: Denise Mafra16 briefTitle: Green Propolis Extract and Royal Jelly in Hypertensive Patients and/or With Chronic Kidney Disease overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2025-07-31 date: 2027-07-31 date: 2024-03-01 date: 2024-03-01 name: Universidade Federal Fluminense class: OTHER name: Conselho Nacional de Desenvolvimento Científico e Tecnológico name: Rio de Janeiro State Research Supporting Foundation (FAPERJ) name: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior. briefSummary: This work aims to evaluate the effects of the association of green propolis extract with royal jelly on inflammation and oxidative stress in participants with CKD and SAH, in a longitudinal, randomized, double-blind, placebo-controlled clinical trial that will be carried out for 2 months. conditions: Chronic Kidney Diseases conditions: Hypertension conditions: Cardiovascular Diseases studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 153 type: ESTIMATED name: Propolis + Royal Jelly name: Royal Jelly name: Placebo measure: Change in inflammation, oxidative stress measure: Change in intestinal microbiota measure: Change in senescence biomarkers measure: Change in uremic toxins measure: Change in adhesion molecules measure: Change in blood pressure sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Denise Mafra city: Rio de Janeiro state: RJ zip: 22260050 country: Brazil name: Denise Mafra, phd role: CONTACT phone: 21985683003 email: dmafra30@gmail.com lat: -22.90278 lon: -43.2075 hasResults: False
<\|newrecord\|> nctId: NCT06288191 id: MIA2023/490 id: CA224-1065 type: OTHER domain: Bristol-Myers Squibb briefTitle: Neoadjuvant Nivolumab and Relatlimab in Cutaneous Squamous Cell Carcinoma overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-06 date: 2036-04 date: 2024-03-01 date: 2024-03-04 name: Melanoma Institute Australia class: OTHER name: Bristol-Myers Squibb briefSummary: The goal of this study is to test neoadjuvant therapy with the dual inhibition of Programmed cell death protein 1 (PD-1) and lymphocyte activation gene 3 (LAG-3) immune checkpoint pathways in a cohort of treatment-naïve, resectable stage II to IV cutaneous squamous cell carcinoma on the pathological response rate (pCR) and recurrence-free survival. conditions: Cutaneous Squamous Cell Carcinoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Open label, single arm, single centre, clinical trial primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: Nivolumab 240 mg / Relatlimab 80 mg in a fixed dose combination measure: Pathological complete response rate measure: Pathological near pathological response (near pCR), partial response (pPR) and pathological non-response (pNR) rate measure: Toxicity and tolerability of neoadjuvant immunotherapy and surgery measure: Objective response rate to neoadjuvant therapy measure: Metabolic response rate to neoadjuvant immunotherapy measure: Recurrence-free survival measure: Disease progression rate measure: Event-free survival rate measure: Overall survival measure: Patient reported quality of life (QLQ-C30) measure: Patient reported quality of life (EQ-5L-5D) measure: Study treatment completion rate and the causes of any missed treatments measure: De-escalation of adjuvant radiotherapy. measure: Identification of tissue and blood biomarkers of response / resistance measure: Profile of the gut microbiome from faecal samples and relationship to response and toxicities. measure: The pathological response to RECIST, immune related response criteria and PERCIST response measure: Assessment of the response to neoadjuvant using the immune-related response criteria (irRC) and correlate the assessment with the RECIST 1.1 response at each timepoint sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06288178 id: 2022/18 briefTitle: The Effect of Consumption of Bread Types Made From Various Flours on Blood Glucose Fluctuations acronym: Obesity overallStatus: COMPLETED date: 2022-12-19 date: 2023-01-20 date: 2023-02-20 date: 2024-03-01 date: 2024-03-01 name: Ege University class: OTHER briefSummary: The obesities were aimed at the effect of whole wheat (WWB), buckwheat (BWB), and cornbread (CB) on blood glucose by comparing the glycemic index values with reference bread (RB).
Overall, WWB consumption had a positive effect on blood glucose in individuals with obesity, while BWB consumption caused an increase in blood glucose levels. conditions: Obesity conditions: Glycemic Index conditions: Blood Glucose conditions: Bread studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: PARTICIPANT count: 103 type: ACTUAL name: Bread consumption measure: One loaf of bread was been consumed every week. Blood glucose measurements were performed with a glucometer at 0 (fasting), 30, 60, 90, and 120 minutes after each bread consumption. measure: This classification as obese and normal-weight individuals was made with the BIA (Bioelectrical impedance analysis) method. This classification was understood by anthropometric measurements made in the first week. sex: ALL minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT facility: Avrasya University city: Trabzon zip: 61000 country: Turkey lat: 41.005 lon: 39.72694 hasResults: False
<\|newrecord\|> nctId: NCT06288165 id: CopperHealthCentre2 briefTitle: Lower Silesia Sinus Reducer Registry acronym: LSSRR overallStatus: RECRUITING date: 2022-05-11 date: 2027-05-11 date: 2027-05-11 date: 2024-03-01 date: 2024-03-01 name: Regional Cardiology Center, The Copper Health Centre (MCZ), class: OTHER briefSummary: Lower Silesia Sinus Reducer Registry is a , single-center, single-arm registry including patients with chronic disabling refractory angina pectoris (Canadian Cardiovascular Society \[CCS\] classes 2-4) despite maximally tolerated anti-angina medical therapy who underwent Coronary Sinus Reducer implantation . conditions: Safety Issues conditions: Efficacy, Self studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 200 type: ESTIMATED name: Coronary Sinus Reducer Implantation measure: The Clinical success - reduction of angina symptoms measure: Incidence of Treatment-Emergent Adverse Events measure: Change in potential aerobic capacity and endurance - The six minute walking test (6MWT) measure: Reducing the severity of angina and it impact on quality of life, as shown by the Seattle Angina Questionnaire. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Cardiology, The Copper Health Centre (MCZ) status: RECRUITING city: Lubin state: Lower Silesia zip: 59-300 country: Poland name: Adrian Włodarczak, M.D; Ph.D.Assoc Prof. role: CONTACT phone: +48768460300 email: wlodarczak.adrian@gmail.com name: Szymon Włodarczak, MD role: CONTACT phone: +4876 846 03 00 email: wlodarczak.szy@gmail.com lat: 51.40089 lon: 16.20149 facility: Cardiac Department of Copper Health Center status: RECRUITING city: Lubin state: Lower Silesia zip: 59301 country: Poland name: Adrian Włodarczak, Prof role: CONTACT phone: 76 846 03 00 phoneExt: 0048 email: wlodarczak.adrian@gmail.com name: Szymon Włodarczak, MD role: CONTACT phone: 76 846 03 00 phoneExt: 0048 email: wlodarczak.szy@gmail.com name: Piotr Rola, Ph D; MD role: SUB_INVESTIGATOR lat: 51.40089 lon: 16.20149 hasResults: False
<\|newrecord\|> nctId: NCT06288152 id: STS-Transplant briefTitle: Evaluation of Thiosulfate Enhanced Organ Preservation Solution in Kidney Transplantation overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2026-03-01 date: 2027-03-01 date: 2024-03-01 date: 2024-03-01 name: Alp Sener class: OTHER briefSummary: End-stage renal disease (ESRD) is a significant clinical problem for which dialysis or transplantation is required. The current need for kidneys for transplantation vastly exceeds the supply available from live donors, necessitating the use of kidneys from deceased donors. However, kidneys from deceased donors are associated with reduced viability, as lack of blood supply upon cardiac death increases tissue damage. In addition, the standard protocol for cold preservation of donor kidneys between procurement and transplantation increases the risk of delayed donor kidney function by 23% for every 6-hours of storage. Moreover, compared to other organs, the kidney is particularly prone to transplantation-induced injury due to its high metabolic activities and oxygen consumption. Hence, any minor disturbances in blood supply can easily lead to kidney injury. Therefore, it is not surprising that deceased donor kidneys have a low tolerance for damage associated with lack of blood supply. The focus of the investigators research has been to pioneer the development and supplementation of existing kidney preservation solutions with novel hydrogen sulfide (H2S) donor molecules to improve kidney viability for clinical transplantation. Specifically, the investigators demonstrated that supplementation of standard kidney preservation solutions with non-clinically viable H2S donor molecules significantly increased donor kidney protection and prolonged transplant recipient survival in murine and porcine models of kidney transplantation. Having shown the same salutary effect using sodium thiosulfate (STS; a clinically viable H2S donor drug) in rat kidney transplantation, the investigators aim to repeat this work using STS in porcine and clinical kidney transplantation.
This single-blind study will enroll participants receiving a kidney transplant. Through randomization, half of the participants will receive STS through administration into the pump the kidney is placed on after procurement from the donor and before transplant to the recipient. Participants will be followed for 1-year post transplant where blood and urine will be collected to determine graft function. conditions: Renal Transplant conditions: Kidney Transplant studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: PARTICIPANT count: 120 type: ESTIMATED name: Sodium Thiosulfate measure: Effects of STS will be measured by: Delayed graft function sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06288139 id: open fracture tibia briefTitle: Management of Open Fracture Tibia in Teenagers overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2025-01-01 date: 2025-02-01 date: 2024-03-01 date: 2024-03-01 name: Assiut University class: OTHER briefSummary: The aim of this study is to study the incidence of open tibial fractures in early teenagers and evaluate the management outcomes conditions: Open tíbia Fracture studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 100 type: ESTIMATED measure: Number measure: To evaluate treatment outcomes measure: Soft tissue healing measure: Complication sex: ALL minimumAge: 10 Years maximumAge: 19 Years stdAges: CHILD stdAges: ADULT hasResults: False
<\|newrecord\|> nctId: NCT06288126 id: MoMM-FET briefTitle: Maternal and Fetal Metabolic Changes acronym: MoMM-FET overallStatus: COMPLETED date: 2019-08-01 date: 2020-10-09 date: 2021-01-18 date: 2024-03-01 date: 2024-03-01 name: Azienda Ospedaliero, Universitaria Pisana class: OTHER briefSummary: The goal of this observational prospective project is to study the metabolic alterations during normal and complicated pregnancies, obtaining an early detection of metabolic changes, offering new insights into future prevention and treatment strategies for both mother and offspring.
Primary objectives:
* measurement of maternal blood adipokine levels, during the first trimester of pregnancy, in two groups of women (high and low risk), in order to identify early markers which, in conjunction with the medical history, can identify women at increased risk of developing GDM
* ultrasound measurement of adipose tissue deposits at ectopic sites, comparing low- and high-risk women, and assessing the effect of pregnancy on these deposits.
* Identification, by targeted ultrasound assessment, of fetuses at increased risk of macrosomia.
Secondary objectives:
* Evaluation of the prevalence of GDM and its complications in a population of low- and high-risk women.
* Evaluation of neonatal complications in children born to low- and high-risk mothers (need for resuscitation, hypoglycaemia, hypocalcaemia, admission to neonatal intensive care unit).
The participants will be recruited during first trimester ultrasound after signing the informed consent. conditions: Pregnancy Related conditions: Maternal-Fetal Relations conditions: Metabolism Disorder, Glucose studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 457 type: ACTUAL measure: Blood adipokine levels measure: Abdominal Fat Thickness measure: Fetal Adipose Tissue Deposits measure: Gestational diabetes prevalence measure: Obstetric complications and mode of delivery sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Azienda Ospedaliera Universitaria Pisana city: Pisa zip: 56126 country: Italy lat: 43.70853 lon: 10.4036 hasResults: False
<\|newrecord\|> nctId: NCT06288113 id: 23-001509 id: NCI-2024-00310 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: 23-001509 type: OTHER domain: UCLA / Jonsson Comprehensive Cancer Center briefTitle: Re-treatment With 177Lu-PSMA-617 for the Treatment of Metastatic Castration-Resistant Prostate Cancer, RE-LuPSMA Trial overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-01-27 date: 2027-01-27 date: 2024-03-01 date: 2024-03-06 name: Jonsson Comprehensive Cancer Center class: OTHER name: Novartis Pharmaceuticals briefSummary: This phase II trial tests how well re-treatment with 177Lu-PSMA-617 works in treating patients with prostate cancer that has spread from where it first started (primary site) to other places in the body (metastatic), that continues to grow or spread after the surgical removal of the testes or medical treatment to block androgen production (castration-resistant), and that has shown a favorable response to initial treatment with 177Lu-PSMA-617. 177Lu-PSMA-617 is a radioactive drug. It binds to a protein called prostate specific membrane antigen (PSMA), which is expressed by some types of prostate tumor cells. When 177Lu-PSMA-617 binds to PSMA-expressing tumor cells, it delivers radiation to the cells, which may kill them. Re-treatment with 177Lu-PSMA-617 in patients who had a favorable response to initial 177Lu-PSMA-617 treatment may improve survival outcomes and disease response in patients with metastatic castration-resistant prostate cancer. conditions: Castration-Resistant Prostate Carcinoma conditions: Stage IVB Prostate Cancer AJCC v8 studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: Biospecimen Collection name: Computed Tomography name: Gallium Ga 68 Gozetotide name: Lutetium Lu 177 Vipivotide Tetraxetan name: Positron Emission Tomography name: Questionnaire Administration name: Single Photon Emission Computed Tomography measure: 12-month overall survival measure: Incidence of adverse events (AEs) measure: Rate of prostate specific antigen (PSA) response measure: Biochemical progression-free survival (PFS) measure: Overall Survival from start of first regimen measure: Overall survival from the end of the first regimen measure: Radiographic progression-free survival (rPFS) measure: Bone Pain measure: Changes in health-related quality of life_Functional Assessment of Cancer Therapy - Radionuclide Therapy (FACT-RNT). measure: Changes in health-related quality of life_Brief Pain Inventory Short form measure: Changes in health-related quality of life_ Eastern Cooperative Oncology Group score sex: MALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: UCLA / Jonsson Comprehensive Cancer Center city: Los Angeles state: California zip: 90095 country: United States name: Ethan Lam role: CONTACT phone: 310-206-7372 email: clam@mednet.ucla.edu name: Stephanie Lira role: CONTACT phone: 3102060596 email: StephanieLira@mednet.ucla.edu name: Jeremie Calais role: PRINCIPAL_INVESTIGATOR lat: 34.05223 lon: -118.24368 hasResults: False
<\|newrecord\|> nctId: NCT06288100 id: OWHTOPTS briefTitle: The Effect of Open Wedge High Tibial Osteotomy on the Posterior Tibial Slope In Skeletally Mature Patient overallStatus: COMPLETED date: 2023-01-01 date: 2023-12-31 date: 2024-01-01 date: 2024-03-01 date: 2024-03-01 name: Al-Azhar University class: OTHER briefSummary: High tibial osteotomy has been established as an efficient surgical intervention for young patients with uni-compartmental osteoarthritis of the knee. The principle of this surgery involves the realignment of the lower extremity to shift the load distribution from the medial compartment into the lateral compartment, thus leading to a decrease in symptoms related to medial compartment knee Osteoarthritis However, medial opening wedge high tibial osteotomy is also known to affect the posterior tibial slope angle , and it is reported that posterior tibial slope angle increases after medial opening wedge high tibial osteotomy . conditions: Genu Varum studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 40 type: ACTUAL name: Observation measure: The Effect of Open Wedge High Tibial Osteotomy on the Posterior Tibial Slope In Skeletally Mature Patient sex: ALL minimumAge: 20 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mohamed Abdelfattah Abbas city: Assiut country: Egypt lat: 27.18096 lon: 31.18368 hasResults: False
<\|newrecord\|> nctId: NCT06288087 id: 2023-20/672 briefTitle: Comparing Machine Guided VR Based Training With Educator Guided Training in Metaverse overallStatus: RECRUITING date: 2024-03-04 date: 2024-03-29 date: 2024-04-11 date: 2024-03-01 date: 2024-03-01 name: Acibadem University class: OTHER briefSummary: The main aim of this study is to compare the learning outcomes of machine guided VR based training for adult advanced life support with educator guided training in metaverse environment. conditions: Advanced Cardiac Life Support conditions: Virtual Reality conditions: Serious Game studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized Controlled Trial primaryPurpose: OTHER masking: SINGLE maskingDescription: the group trained with VR Based Training with Machine Guidance will be referred as MG group and the group trained with VR Based Training with Educators Guidance in Metaverse will be referred as EG group. whoMasked: PARTICIPANT count: 62 type: ESTIMATED name: VR Based Training with Machine Guidance (MG Group) name: VR Based Training with Educator Guidance in Metaverse (EG Group) measure: Comparing Learning outcome of the Advanced Cardiac Life Support Training of the two interventions used in this study sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Acibadem University CASE (Center of Advanced Simulation and Education) status: RECRUITING city: Istanbul state: Non-US/Canada zip: 34752 country: Turkey name: Dilek Kitapcioglu, Assist.Prof role: CONTACT phone: +905323636115 email: dilek.kitapcioglu@acibadem.edu.tr name: Mehmet Emin Aksoy, Assoc.Prof role: CONTACT phone: +905052685158 email: emin.aksoy@acibadem.edu.tr name: Dilek Kitapcioglu, Assist.Prof role: PRINCIPAL_INVESTIGATOR name: Mehmet Emin Aksoy, Assoc.Prof role: PRINCIPAL_INVESTIGATOR name: Arun Ekin Ozkan, M.Sc. role: SUB_INVESTIGATOR name: Tuba Usseli, M.Sc. role: SUB_INVESTIGATOR lat: 41.01384 lon: 28.94966 facility: Acibadem University CASE (Center of Advanced Simulation and Education) status: NOT_YET_RECRUITING city: Istanbul state: Non-US/Canada zip: 34752 country: Turkey name: Mehmet Emin Aksoy, Assoc.Prof role: CONTACT phone: +902165004201 email: emin.aksoy@acibadem.edu.tr name: Dilek Kitapcioglu, Ph.D. role: CONTACT phone: +2165004202 phoneExt: Aksoy email: dilek.kitapcioglu@acibadem.edu.tr name: Dilek Kitapcioglu, MD, Ph.D. role: PRINCIPAL_INVESTIGATOR name: Mehmet Emin Aksoy, MD, Ph.D. role: PRINCIPAL_INVESTIGATOR name: Arun Ekin Ozkan, M.Sc. role: SUB_INVESTIGATOR name: Tuba Usseli, M.S role: SUB_INVESTIGATOR lat: 41.01384 lon: 28.94966 hasResults: False
<\|newrecord\|> nctId: NCT06288074 id: SF-2022-1-1061 briefTitle: Diagnosis and Treatment Strategy Optimization of Severe Pneumonia Based on Multi-omics Data Integration overallStatus: RECRUITING date: 2024-03-10 date: 2024-12-31 date: 2024-12-31 date: 2024-03-01 date: 2024-03-01 name: Capital Medical University class: OTHER briefSummary: Severe community-acquired pneumonia still has a high incidence and mortality, but the molecular mechanism and prognostic biomarkers of severe community-acquired pneumonia caused by different pathogens are still unclear, and the best treatment strategy has not been determined. Based on this, this project intends to take patients with severe community-acquired pneumonia caused by different pathogens as the research object, explore the molecular mechanism of severe community-acquired pneumonia from multiple angles, integrate relevant research data to evaluate the rationality of initial empirical medication, and lay the foundation for precise treatment of severe pneumonia. The research results will help to develop a new rapid and accurate target for clinical diagnosis and efficacy evaluation of severe pneumonia, and build a precise treatment system for severe pneumonia. conditions: Severe Community-acquired Pneumonia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 300 type: ESTIMATED name: Multi-omics tests measure: Hospital mortality measure: Cause of death measure: Length of stay measure: Length of ICU stay measure: Expense during hospitalization sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Beijing Institute of Respiratory Medicine status: RECRUITING city: Beijing state: Beijing zip: 100027 country: China name: Zhaohui Tong, Dr role: CONTACT phone: +86 010 8523 1000 email: 13910930309@163.com lat: 39.9075 lon: 116.39723 hasResults: False
<\|newrecord\|> nctId: NCT06288061 id: Phrenic Nerve Neuromodulation briefTitle: Effectiveness of Non-invasive Phrenic Nerve Neuromodulation in Subjects With Inflammatory Bowel Disease and Neck Pain. overallStatus: NOT_YET_RECRUITING date: 2024-03-20 date: 2025-06-06 date: 2025-07-04 date: 2024-03-01 date: 2024-03-05 name: University of Seville class: OTHER briefSummary: Inflammatory bowel diseases (IBD) are chronic relapsing diseases that generate an autoimmune response against the bowel and its microbiota. Its prevalence is increasing worldwide. These include Ulcerative Colitis (UC) and Crohn's Disease(CD).
The Phrenic nerve originates at the roots C3-C4-C5 carrying motor and sensory information. Directly or through connections it innervates the diaphragm, pleura, right atrium, pericardium, oesophagus, peritoneum, stomach, falciform and coronary ligaments of the liver, Glisson's capsule, hepatic and inferior vena cava, liver (parenchyma), gallbladder and the rest of the biliary tract, pancreas, small intestine and adrenal glands. It also has fibres of the autonomic nervous system.
Studies show that there is a link between people suffering from IBD and hepatopancreato-biliary diseases. It can therefore generate referred pain to the C3-C4-C5 dermatomes.
Based on the above, the main objective would be to analyse whether non-invasive neuromodulation of the Phrenic nerve reduces neck pain in people with IBD. Secondary objectives were to assess the impact of treatment on quality of life and to study the relationship between IBD and cervical pain.
Hypothesis:
Non-invasive Phrenic nerve neuromodulation in subjects suffering from inflammatory bowel disease and neck pain will improve their quality of live, disability and sensitisation, as well as neck pain and mobility. conditions: Inflammatory Bowel Diseases conditions: Neck Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 68 type: ESTIMATED name: Non-invasive Neuromodulation name: Cervico-dorsal Massage measure: The Visual Analogue Scale (VAS) measure: Cervical mobility measure: The Neck Disability Index (NDI) measure: The Pressure Pain Threshold (PPT) measure: The Inflammatory Bowel Disease Questionnaire (IBDQ-32) measure: The World Health Organization Quality of Life (WHOQOL-BREF) measure: The Central Sensitization Inventory (CSI) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital Universitario Puerto Real city: Puerto Real state: Cádiz zip: 11510 country: Spain lat: 36.52819 lon: -6.19011 hasResults: False
<\|newrecord\|> nctId: NCT06288048 id: 23/107-EC X TFM 07/03/2023 briefTitle: Effect of Mirror Therapy on Post-Needling Pain Following Deep Dry Needling of Myofascial Trigger Point in Lateral Elbow Pain overallStatus: ACTIVE_NOT_RECRUITING date: 2023-04-01 date: 2024-03-07 date: 2024-06-30 date: 2024-03-01 date: 2024-03-01 name: Universidad Europea de Canarias class: OTHER briefSummary: The goal of this randomized, controlled pilot trial is to investigate the immediate effects of incorporating Mirror Visual Feedback Therapy (MFT) on pain sensitivity and motor performance in individuals experiencing Post-needling pain associated with lateral elbow pain. The main questions it aims to answer are:
* Does incorporating Mirror Visual Feedback Therapy reduce Post-needling pain intensity?
* Does incorporating Mirror Visual Feedback Therapy improve pressure pain threshold?
* Does incorporating Mirror Visual Feedback Therapy improve maximum grip strenght?
Participants will be asked to undergo pre- and post-treatment evaluations, which include assessments of Post-needling pain intensity, pressure pain threshold, two-point discrimination threshold, and maximum hand grip strength.
Participants in the Experimental Group will receive Deep Dry Needling in the m. Brachioradialis, Ischemic Compression, Cold Spray, Stretching, and Mirror Visual Feedback Therapy. Those in the Control Group will not receive Mirror Visual Feedback Therapy.
Researchers will compare the Experimental Group to the Control Group to see if the incorporation of Mirror Visual Feedback Therapy results in a reduction in Post-needling pain intensity and improvement in pressure pain threshold. conditions: Lateral Elbow Pain studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Allocation and data assessor were blinded. whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 49 type: ESTIMATED name: Experimental: Deep Dry Needling (DDN), Ischemic Compression, Cold Spray with Stretching + MFT name: Deep Dry Needling (DDN), Ischemic Compression, Cold Spray with Stretching measure: Pain Intensity measure: Pain pressure threshold measure: Two-point discrimination threshold measure: Maximum hand grip strength sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Universidad Europea de Canarias city: La Orotava state: Santa Cruz De Tenerife zip: 38300 country: Spain lat: 28.39076 lon: -16.52309 hasResults: False
<\|newrecord\|> nctId: NCT06288035 id: R.21.02.1191 briefTitle: Oral Dexamethasone for Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy overallStatus: RECRUITING date: 2024-03-04 date: 2025-03 date: 2025-03 date: 2024-03-01 date: 2024-03-12 name: Mansoura University class: OTHER briefSummary: Postoperative nausea and vomiting (PONV) are common complications after laparoscopic cholecystectomy. This study aims to evaluate the efficacy of the administration of prophylactic oral dexamethasone at night before surgery in preventing PONV after elective laparoscopic cholecystectomy. conditions: Postoperative Nausea and Vomiting studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is a parallel, two-arm, randomized (1:1), controlled, single-center non-inferiority trial. Adults (≥18 years) with ASA physical status I-III scheduled for elective laparoscopic cholecystectomy will be eligible for inclusion. The participants will be randomized to receive either 8 mg of IV Dexamethasone at the time of induction of anesthesia or 8 mg of oral Dexamethasone at night before surgery. The primary outcome will be the incidence of postoperative nausea and vomiting. 814 patients are intended to be recruited for this non-inferiority trial. primaryPurpose: PREVENTION masking: SINGLE maskingDescription: The outcome assessors will be blinded to the group allocation. whoMasked: OUTCOMES_ASSESSOR count: 814 type: ESTIMATED name: Dexamethasone Oral name: Dexamethasone measure: Postoperative nausea or vomiting (PONV) measure: Rescue antiemetic measure: Early PONV measure: Late PONV measure: Visual Analogue Scale (VAS) at the time of discharge from PACU measure: VAS at the time of discharge from hospital measure: Postoperative fatigue measure: Postoperative quality of recovery measure: Post-Discharge Nausea and Vomiting (PDNV) measure: Surgical Site Infection (at follow-up) measure: Itching or burning sensation on dexamethasone injections sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mansoura University Faculty of Medicine status: RECRUITING city: Mansoura state: Aldakahlia zip: 35516 country: Egypt name: Moataz M Emara, MD, EDAIC role: CONTACT phone: 01064048848 email: mm.emara@mans.edu.eg lat: 31.03637 lon: 31.38069 hasResults: False
<\|newrecord\|> nctId: NCT06288022 id: COA. MURA2023/947 briefTitle: Comparison of Total Tubeless Mini-PCNL Versus Tubeless Mini-PCNL overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-04-30 date: 2026-06-30 date: 2024-03-01 date: 2024-03-07 name: Mahidol University class: OTHER briefSummary: Limited literature has focused on the use of totally tubeless mini-percutaneous nephrolithotomy (Mini-PCNL) for the treatment of large renal stones.
This Randomized Controlled trial aims to compare complication and safety of Mini-PCNL between total tubeless and tubeless Mini-PCNL. conditions: Surgery-Complications conditions: Nephrolithiasis Staghorn Calculus conditions: Safety Issues studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized Controlled Trial in 2 group
1. total tubeless mini-PCNL
2. tubeless mini-PCNL primaryPurpose: OTHER masking: DOUBLE maskingDescription: All eligible patients will be provided with an explanation of the research and invited to participate.
Patient will participate or not depends on whether they not meet the surgical exclusion criteria. If they meet the criteria, they will not participate in the research. If they not meet the criteria, they will be randomly assigned to one of the groups.
Patients will not be informed of the treatment intervention in advance whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 130 type: ESTIMATED name: total tubeless mini-PCNL name: tubeless mini-PCNL measure: incidence of complications between total tubeless mini-pcnl and tubeless mini-PCNL measure: The secondary objective is to assess the surgical outcomes between total tubeless mini-pcnl and tubeless mini-PCNL sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ramathibodi Hospital, Mahidol University city: Bangkok state: Ratchathewi zip: 10400 country: Thailand name: Thanakorn Sirajarus role: CONTACT phone: 086-599-3259 email: Thanakorn.sjr@gmail.com name: Chinnakhet Ketsuwan role: CONTACT phone: 086-345-6901 email: chinnakhet.ket@mahidol.ac.th lat: 13.75398 lon: 100.50144 hasResults: False
<\|newrecord\|> nctId: NCT06288009 id: 2135389 briefTitle: Outcomes of Running Locking Suture vs Standard Running Suture in Surgical Wounds overallStatus: RECRUITING date: 2024-03-01 date: 2025-03-01 date: 2025-06-01 date: 2024-03-01 date: 2024-03-01 name: University of California, Davis class: OTHER briefSummary: When patients have surgery on the head and face, stitches are the standard way to close the wound. Wounds always result in a scar, but doctors are always looking for ways to reduce scarring. Several studies have been done to test ways to close wounds that reduce scarring. The most commonly performed closure technique uses running sutures, where a single strand of suture is continued along the length of the wound with a series of uninterrupted stiches. However, alternative closure techniques exist such as the running locking suture, which can offer advantages such as improved tension and thus reduce post-operative complications with better aesthetic outcome. In this study, half the wound will be stitched with standard running sutures and the other half will be stitched with running locking sutures. This will allow us to see if the side with running locking sutures heals with less scarring. conditions: Scarring studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: SINGLE maskingDescription: Two blinded observers will record their scores independently using the POSAS instrument. whoMasked: OUTCOMES_ASSESSOR count: 50 type: ESTIMATED name: Running locking suture name: Standard running suture measure: Observer Scar Assessment as measured by Patient Observer Scar Assessment Score (POSAS) measure: Patient Scar Assessment as measured by Patient Observer Scar Assessment Score (POSAS) measure: Width of Scar as measured using Trace-to-Tape Method measure: Complications or Adverse Events from Treatment sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of California, Davis - Dermatology Department status: RECRUITING city: Sacramento state: California zip: 95816 country: United States name: John Robb, BS role: CONTACT phone: 916-551-2636 email: jmrobb@ucdavis.edu name: Daniel Eisen, MD role: CONTACT phone: 916-551-2611 email: dbeisen@ucdavis.edu name: Daniel Eisen, MD role: PRINCIPAL_INVESTIGATOR name: Keemberly Kim, MD role: SUB_INVESTIGATOR name: Samantha Daniel, MD role: SUB_INVESTIGATOR lat: 38.58157 lon: -121.4944 hasResults: False
<\|newrecord\|> nctId: NCT06287996 id: 23MMHIS503e NA briefTitle: Effects of Warm Water Footbath Intervention on Sleep Quality , Fatigue and Heart Rate Variability in Patients With Heart Failure overallStatus: ENROLLING_BY_INVITATION date: 2024-02-23 date: 2024-06-01 date: 2024-08-01 date: 2024-03-01 date: 2024-03-01 name: Mackay Memorial Hospital class: OTHER briefSummary: This study adopted an experimental research design to explore the effects of a warm water foot bath program on fatigue, sleep, and heart rate variability in patients with heart failure. The subjects of the study were heart failure patients in the cardiology outpatient department. The patients were randomly assigned to the experimental group and the control group. The control group received routine care and wore an actigraph. The experimental group received 4 additional care in addition to routine care and wearing an actigraph. Weekly warm water foot bath, data collection includes subjective sleep quality and fatigue level, physiological measurements: sleep quality-sleep time and efficiency, and heart rate variability index. conditions: Footbath conditions: Heart Failure conditions: Sleep Quality conditions: Fatigue conditions: Heart Rate Variability studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 76 type: ESTIMATED name: footbath and actigraphy name: actigraphy measure: sleep quality measure: fatigue measure: heart rate variability sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mackay Memorial Hospital city: Taipei state: Zhongshan zip: 104 country: Taiwan lat: 25.04776 lon: 121.53185 hasResults: False
<\|newrecord\|> nctId: NCT06287983 id: KayseriCHIMT001 briefTitle: Effect of Inspiratory Muscle Training on Respiratory Functions and Exercise Capacity overallStatus: RECRUITING date: 2023-06-01 date: 2024-03-31 date: 2024-05-15 date: 2024-03-01 date: 2024-03-07 name: Kayseri City Hospital class: OTHER_GOV briefSummary: In this study, we aimed to evaluate the effect of Anti- tumor necrosis factor (TNF) treatment on pulmonary functions in patients with AS and to evaluate the pulmonary functions and exercise performance of patients by adding inspiratory muscle training to spinal mobility exercises in patients with AS using Anti-TNF. We also aimed to investigate the relationship between these parameters and disease activity, spinal mobility and quality of life. conditions: Ankylosing Spondylitis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: A total of 44 patients were randomly divided into 2 groups using the sealed envelope randomization method. The exercise program will be applied to both groups 3 sessions a week for 60 minutes for 6 weeks. Inspiratory muscle training will also be added to the intervention group. Patients included in the study; At weeks 0, 6, 12 and 24, BASDAI (Bath Ankylosing Spondylitis Disease Activity Index), BASFI (Bath Ankylosing Spondylitis Functional Index), ASQoL (The Ankylosing Spondylitis Quality of Life), Modified Borg Scale, Visual Analog scale (VAS) and maximum Dyspnea measurement during exercise, 6-minute walk test, chest expansion measurement and respiratory function test (spirometry) will be evaluated. primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 44 type: ESTIMATED name: Inspiratory Muscle Trainer (IMT) (POWERbreathe Medic Classic) name: The Sample Spondylitis Exercise Program measure: Respiratory function test (Spirometry) measure: Bath Ankylosing Spondylitis Disease Activity Index (BASDAI): measure: Bath Ankylosing Spondylitis Functional Index (BASFI) measure: Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL) measure: Modified Borg Scale measure: Measurement of dyspnea at maximum exercise with the Visual Analog Scale (VAS) measure: 6-minute walk test (6MWT) measure: Chest expansion measurement sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Health Sciences University, Kayseri Medicine Faculty, Kayseri City Hospital status: RECRUITING city: Kayseri zip: 38080 country: Turkey name: Havva Talay Çalış, Prof role: CONTACT phone: +90352 315 77 00 phoneExt: 61244 email: htalaycalis@yahoo.com name: Esra Yaprak Tas, MD role: CONTACT phone: +905062007571 email: yaprak8100@gmail.com lat: 38.73222 lon: 35.48528 hasResults: False
<\|newrecord\|> nctId: NCT06287970 id: 2023-250-KY briefTitle: TaVNS Improves the Symptoms of Patients With Moderate to Severe CP/CPPS overallStatus: NOT_YET_RECRUITING date: 2024-03-15 date: 2026-12-31 date: 2027-02-18 date: 2024-03-01 date: 2024-03-21 name: Jiani Wu class: OTHER briefSummary: This trial aims to evaluate the efficacy and safety of transcutaneous auricular vagus nerve stimulation (taVNS) for moderate to severe chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS). This study is a prospective, randomized, controlled trial. A total of 68 patients with CP/CPPS will be recruited. After baseline assessment, the patients will be randomized into taVNS group (n = 34) and sham-taVNS group (n = 34). The intervention of two group will last for 4 weeks with a 8-week follow-up period after the treatment. The National Institutes of Health chronic Prostatitis Symptom Score index (NIH-CPSI), International Prostate Symptom Score Scale (IPSS), European quality of Life-5 Dimensions Questionnaire (EQ-5D), self-rating anxiety Scale (SAS) and self-rating depression scale (SDS) will be assessed. The adverse events during the whole study will be recorded detailedly. conditions: Chronic Prostatitis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 68 type: ESTIMATED name: Transcutaneous Auricular Vagus Nerve Stimulation name: Sham Transcutaneous Auricular Vagus Nerve Stimulation measure: Change from baseline in National Institute of Health Chronic Prostatitis Symptom Index(NIH-CPSI) total score at week 4 measure: Change from baseline in National Institute of Health Chronic Prostatitis Symptom Index(NIH-CPSI) total score at week 8 and week 12 measure: The changes from baseline of NIH-CPSI pain score, urinary score and quality of life score, respectively at week 4, 8 and 12 measure: Proportion of responders at week 4, 8 and 12 measure: The change from baseline in International Prostate Symptom Score (IPSS) score at week 4, 8 and 12 measure: The change from baseline in EuroQol Five Dimensions Questionnaire (EQ-5D) at week 4, 8 and 12 measure: The change from baseline in Self-rating Anxiety Scale (SAS) at week 4, 8 and 12 measure: The change from baseline in the Self-rating Depression Scale (SDS) at week 4, 8 and 12 measure: Evaluation of patient expectations measure: Blinding Evaluation measure: Incidence of Treatment-Emergent Adverse Events sex: MALE minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Guang'anmen Hospita, China Academy of Chinese Medical Sciences city: Beijing state: Beijing zip: 100053 country: China name: Jiani Wu role: CONTACT phone: +8613426116653 email: jiani_wu@aliyun.com lat: 39.9075 lon: 116.39723 hasResults: False
<\|newrecord\|> nctId: NCT06287957 id: IU-DHF-AG-01 briefTitle: Chitosan Brushes vs Air-Abrasive Devices on Peri-implant Mucositis Treatment: A Randomized Clinical overallStatus: RECRUITING date: 2024-03-01 date: 2024-10-01 date: 2025-02-15 date: 2024-03-01 date: 2024-03-01 name: Istanbul University class: OTHER briefSummary: Bleeding on probing (0,1,2,3), plaque index (+,-) and pocket probing depth will be recorded for each visit. Before the procedure, the patient will be randomly assigned to one of four groups and records will be kept. In the frst visit of the patient, necessary actions will be taken according to the group to which the patient is assigned. The implant periphery of the patients assigned to the chitosan brush group will be debrided with a chitosan brush with circular movements. The implants of the patients assigned to the air abrasive device group will be cleaned in the same way with circular movements. The debrided area of both groups will be washed with sterile serum after the treatment. Patients will be called at the 2nd, 4th and 12th weeks and compared with the records kept. conditions: Peri-implant Mucositis conditions: Peri-Implantitis conditions: Bleeding on Probing conditions: Periodontal Pocket studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: There are going to be 4 treatment groups. Group 1: Mini Implant Platform treated with Labrida Bioclean Group 2: Regular Implant Platform treated with Labrida Bioclean Group 3: Mini Implant Platform treated with Air-Flow Device Group 4: Regular Implant Platform treated with Air-Flow Device primaryPurpose: PREVENTION masking: NONE count: 54 type: ESTIMATED name: Labrida BioClean name: EMS Handy 3.0 Perio Premium measure: Probing Depth measure: Bleeding on Probing measure: Plaque Index sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Istanbul University status: RECRUITING city: Istanbul state: Fatih zip: 34080 country: Turkey name: Alper Gultekin, Assistant Professor role: CONTACT phone: +90 5326757236 email: alperg@istanbul.edu.tr name: Kerem Bahceci, PhD Candidate role: CONTACT phone: +90 5317132633 email: kerembhc@gmail.com lat: 41.01384 lon: 28.94966 hasResults: False
<\|newrecord\|> nctId: NCT06287944 id: 23694 id: NCI-2024-01131 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: 23694 type: OTHER domain: City of Hope Medical Center id: P30CA033572 type: NIH link: https://reporter.nih.gov/quickSearch/P30CA033572 briefTitle: 225Ac-DOTA-Anti-CD38 Daratumumab Monoclonal Antibody With Fludarabine, Melphalan and Total Marrow and Lymphoid Irradiation as Conditioning Treatment for Donor Stem Cell Transplant in Patients With High-Risk Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia and Myelodysplastic Syndrome overallStatus: NOT_YET_RECRUITING date: 2024-06-18 date: 2027-02-24 date: 2027-02-24 date: 2024-03-01 date: 2024-03-01 name: City of Hope Medical Center class: OTHER name: National Cancer Institute (NCI) briefSummary: This phase I trial tests the safety, side effects, best dose, and effectiveness of 225Ac-DOTA-Anti-CD38 daratumumab monoclonal antibody in combination with fludarabine, melphalan and total marrow and lymphoid irradiation (TMLI) as conditioning treatment for donor stem cell transplant in patients with high-risk acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL) and myelodysplastic syndrome (MDS). Daratumumab is in a class of medications called monoclonal antibodies. It binds to a protein called CD38, which is found on some types of immune cells and cancer cells. Daratumumab may block CD38 and help the immune system kill cancer cells. Radioimmunotherapy is treatment with a radioactive substance that is linked to a monoclonal antibody, such as daratumumab, that will find and attach to cancer cells. Radiation given off by the radioisotope my help kill the cancer cells. Chemotherapy drugs, such as fludarabine and melphalan, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. TMLI is a targeted form of body radiation that targets marrow, lymph node chains, and the spleen. It is designed to reduce radiation-associated side effects and maximize therapy effect. Actinium Ac 225-DOTA-daratumumab combined with fludarabine, melphalan and TMLI may be safe, tolerable, and/or effective as conditioning treatment for donor stem cell transplant in patients with high-risk AML, ALL, and MDS. conditions: Acute Lymphoblastic Leukemia conditions: Acute Myeloid Leukemia conditions: Myelodysplastic Syndrome studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 15 type: ESTIMATED name: Actinium Ac 225-DOTA-Daratumumab name: Biospecimen Collection name: Bone Marrow Aspiration name: Bone Marrow Biopsy name: Computed Tomography name: Daratumumab name: Echocardiography name: Fludarabine name: Hematopoietic Cell Transplantation name: Indium In 111-DOTA-Daratumumab name: Melphalan name: Multigated Acquisition Scan name: Radionuclide Imaging name: Single Photon Emission Computed Tomography name: Sirolimus name: Tacrolimus name: Total Marrow and Lymphoid Irradiation measure: Incidence of adverse events (CTCAE) measure: Incidence of adverse events (Bearman) measure: Dose limiting toxicity (DLT) measure: Maximum tolerated dose/recommended phase II dose (MTD/RP2D) measure: Overall survival (OS) measure: Event-free survival (EFS) measure: Cumulative incidence of relapse/progression (CIR) measure: Graft versus host disease and relapse free survival (GRFS) measure: Complete remission (CR) proportion measure: Non-relapse mortality (NRM) measure: Incidence of infection measure: Neutrophil recovery rate measure: Incidence of grade 2-4 and 3-4 acute graft-versus-host disease (GVHD) measure: Incidence of chronic GVHD (cGVHD) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: City of Hope Medical Center city: Duarte state: California zip: 91010 country: United States name: Jeffrey Y. Wong role: CONTACT phone: 626-218-2247 email: jwong@coh.org name: Jeffrey Y. Wong role: PRINCIPAL_INVESTIGATOR lat: 34.13945 lon: -117.97729 hasResults: False
<\|newrecord\|> nctId: NCT06287931 id: sdllycyy001 briefTitle: Probiotics for Gallstones in Post-bariatric Surgery Patients overallStatus: RECRUITING date: 2024-01-01 date: 2025-06-01 date: 2025-06-01 date: 2024-03-01 date: 2024-03-01 name: Shandong Linglong Yingcheng Hospital class: NETWORK briefSummary: Obesity is an increasing epidemic worldwide and has a significant impact on human health and socioeconomics. Multiple studies have shown that bariatric surgery increases the risk of postoperative gallbladder stones. Contributing factors to gallstone formation include gallbladder motility and bile supersaturation due to rapid weight loss and cholesterol mobilization. At present, the prevention and treatment of gallbladder stones in obese patients after bariatric surgery are still controversial. In recent years, the study of ursodeoxycholic acid in preventing gallbladder stone formation after bariatric surgery has become a research hotspot. At the same time, other studies have shown that taking probiotics or digestive enzymes may improve gastrointestinal symptoms and improve quality of life after bariatric surgery. Therefore, the purpose of this study was to determine the ability of probiotics to prevent gallstone formation after bariatric surgery and to evaluate the impact of oral probiotics on quality of life in patients after bariatric surgery. conditions: Bariatric Surgery Candidate conditions: Gallstone conditions: Gallstone Attack conditions: Gastrointestinal Quality of Life Index conditions: Probiotics studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 400 type: ESTIMATED name: Ursodoxycholic acid group name: Bifidobacterium group measure: The incidence of gallstones in bariatric surgery patients sex: ALL minimumAge: 20 Years maximumAge: 60 Years stdAges: ADULT facility: Shandong Linglong Yingcheng Hospital status: RECRUITING city: Yantai state: Shandong zip: 264000 country: China name: Xuan Qiu, MD role: CONTACT phone: 8618354280081 email: qiuxuan100@163.com name: Ni Wang, MD role: CONTACT phone: 8618705353551 email: wangni1989@163.com lat: 37.47649 lon: 121.44081 hasResults: False
<\|newrecord\|> nctId: NCT06287918 id: 3HP-2827-101 briefTitle: A First-in-human Study of 3HP-2827 in Patients With Unresectable or Metastatic Solid Tumors With FGFR2 Alterations overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2028-03 date: 2028-06 date: 2024-03-01 date: 2024-04-11 name: 3H (Suzhou) Pharmaceuticals Co., Ltd. class: INDUSTRY briefSummary: The study is being conducted to evaluate the safety, tolerability, efficacy, pharmacokinetics, and pharmacodynamics of 3HP-2827 in the treatment of unresectable or metastatic solid tumors with FGFR2 alterations. Patients will be enrolled in two stages: dose escalation stage (Stage I) and expansion stage (Stage II). conditions: Solid Tumors With FGFR2 Alterations, Adult studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 130 type: ESTIMATED name: 3HP-2827 measure: Dose Escalation Stage- incidence of adverse events (AEs) measure: Dose Escalation Stage- incidence of dose-limiting toxicities (DLTs) measure: Dose Escalation Stage -Percentage of Participants With Changes From Baseline in Targeted Vital Signs measure: Dose Escalation Stage -Percentage of Participants With Changes From Baseline in Targeted Clinical Laboratory Test Results measure: Dose Escalation Stage -Percentage of Participants With Changes From Baseline in Targeted ECG Parameters measure: Dose Escalation Stage -determine the maximum tolerated dose (MTD) and/or the recommended dose (RD) for expansion stage or recommended Phase II dose (RP2D) of 3HP-2827 measure: Expansion stage -Objective response rate（ORR） measure: Plasma Concentration of 3HP-2827 and/or its major metabolites measure: Duration of Response (DOR) as assessed by RECIST v1.1 measure: Progression-free survival (PFS) as assessed by RECIST v1.1 measure: Overall survival measure: Dose escalation stage - Objective Response Rate (ORR) measure: Expansion Stage- incidence of adverse events (AEs) measure: Expansion Stage -Percentage of Participants With Changes From Baseline in Targeted Vital Signs measure: Expansion Stage -Percentage of Participants With Changes From Baseline in Targeted Clinical Laboratory Test Results measure: Expansion Stage -Percentage of Participants With Changes From Baseline in Targeted ECG Parameters sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mayo Clinic city: Phoenix state: Arizona zip: 85054 country: United States lat: 33.44838 lon: -112.07404 facility: The University of Texas MD Anderson Cancer Center city: Houston state: Texas zip: 77030 country: United States lat: 29.76328 lon: -95.36327 hasResults: False
<\|newrecord\|> nctId: NCT06287905 id: Soh-Med-23-02-24 briefTitle: A Comparative Study of Using Scorpion Antivenom Versus Scorpion Antivenom and Prazosin overallStatus: RECRUITING date: 2023-02-01 date: 2024-07-01 date: 2024-07-01 date: 2024-03-01 date: 2024-03-01 name: Sohag University class: OTHER briefSummary: Interventional study designed for the evaluation of characters and the outcome of scorpion sting patients will admit to Sohag University Hospitals in 2 randomized groups. The first group will receive scorpion antivenom only whether by the intravenous or the intramuscular route of administration. The second group will receive a combination of prazosin plus scorpion antivenom whether by the intravenous or the intramuscular route of administration. Both groups will receive proper first aid and supportive treatment conditions: Morality studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: observational comparative primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Simple randomization whoMasked: PARTICIPANT count: 80 type: ESTIMATED name: Prazosin Oral Tablet measure: Mortality measure: Morbidity sex: ALL minimumAge: 1 Year maximumAge: 70 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Meray Medhat Shokry Zaghary status: RECRUITING city: Sohag zip: 82515 country: Egypt name: Meray M Shokry Zaghary role: CONTACT phone: +201028911003 email: drevanho2013@gmail.com name: Mai M Abd El Kader role: CONTACT phone: +201028911003 email: drevanho2013@gmail.com lat: 26.55695 lon: 31.69478 hasResults: False
<\|newrecord\|> nctId: NCT06287892 id: AI-ECG-HCM briefTitle: Diagnosis of HCM With AI-ECG overallStatus: RECRUITING date: 2024-01-01 date: 2024-12-31 date: 2024-12-31 date: 2024-03-01 date: 2024-03-06 name: Shanghai Zhongshan Hospital class: OTHER briefSummary: The study aims to establish a diagnostic model of hypertrophic cardiomyopathy with artificial intelligence-enhanced electrocardiogram. conditions: Hypertrophic Cardiomyopathy studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 10000 type: ESTIMATED measure: Diagnosis of HCM with AI-ECG sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: 180 Fenglin Road status: RECRUITING city: Shanghai zip: 200032 country: China name: Yixiu Liang, MD role: CONTACT phone: +8664041990 phoneExt: 612844 email: liang.yixiu@zs-hospital.sh.cn lat: 31.22222 lon: 121.45806 hasResults: False
<\|newrecord\|> nctId: NCT06287879 id: 20231121 briefTitle: Function and Morphological Characteristics of Meibomian Gland in Patients With Renal Anemia overallStatus: RECRUITING date: 2023-04-01 date: 2024-12-20 date: 2024-12-30 date: 2024-03-01 date: 2024-03-01 name: Zhongnan Hospital class: OTHER briefSummary: Renal anemia refers to anemia in which the absolute or relative production of erythropoietin (EPO) is insufficient due to various kidney diseases, and uremic toxins affect erythropoietin production and its lifespan. Common treatment drugs for renal anemia include erythropoietin EPO and Roxadustat (FG-4592).
Medical history information was collected from patients with renal anemia who visited the ophthalmology department with dry eye symptoms.
This study will help to determine the function and morphological characteristics of meibomian gland in patients with renal anemia conditions: Dry Eye conditions: MGD-Meibomian Gland Dysfunction studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 50 type: ESTIMATED name: Dry eye examination measure: Lacrimal river height measure: tear break-up time measure: tear-film lipid layer thickness measure: meibomian glands two-dimensional digital infrared images sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Zhongnan Hospital of Wuhan University status: RECRUITING city: Wuhan state: Hubei zip: 430071 country: China name: Min Ke, Doctor role: CONTACT phone: +86-18672395959 email: keminyk@163.com lat: 30.58333 lon: 114.26667 hasResults: False
<\|newrecord\|> nctId: NCT06287866 id: 2099470 briefTitle: Pinch Grafting Versus Second Intention Wound Healing for Mohs Micrographic Surgery Defects on the Scalp overallStatus: RECRUITING date: 2024-03-01 date: 2025-03-01 date: 2025-06-01 date: 2024-03-01 date: 2024-03-01 name: University of California, Davis class: OTHER briefSummary: Oftentimes, following surgery on the scalp, wounds are left to heal by themselves. This is called "second intention." Open wounds left to heal on the scalp often take 8 weeks or more to completely heal. We are investigating how second intention closure compares to another established reconstruction technique, called "pinch graft." In the pinch graft technique, we numb and then shave off a thin piece of skin (usually from the groin area) and place it in the wound bed it (also known as "grafting"), to encourage growth of new healthy skin. This study will compare time-to-healing in the second intention method versus the pinch graft method. conditions: Scarring studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: SINGLE maskingDescription: Two blinded observers will record their scores independently using the POSAS instrument. whoMasked: OUTCOMES_ASSESSOR count: 50 type: ESTIMATED name: Pinch Graft measure: Time to re-epithelialization measure: Observer Scar Assessment as measured by Patient Observer Scar Assessment Score (POSAS) measure: Patient Scar Assessment as measured by Patient Observer Scar Assessment Score (POSAS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of California, Davis - Dermatology Department status: RECRUITING city: Sacramento state: California zip: 95816 country: United States name: John Robb, BS role: CONTACT phone: 916-551-2636 email: jmrobb@ucdavis.edu name: Daniel Eisen, MD role: CONTACT phone: 916-551-2611 email: dbeisen@ucdavis.edu name: Daniel Eisen, MD role: PRINCIPAL_INVESTIGATOR name: Keemberly Kim, MD role: SUB_INVESTIGATOR name: Ilana Breen, MD role: SUB_INVESTIGATOR lat: 38.58157 lon: -121.4944 hasResults: False
<\|newrecord\|> nctId: NCT06287853 id: EMBODY-004 briefTitle: Tapestry Rotator Cuff Repair PMCF overallStatus: NOT_YET_RECRUITING date: 2024-06-30 date: 2028-06-30 date: 2029-06-30 date: 2024-03-01 date: 2024-03-01 name: Zimmer Biomet class: INDUSTRY briefSummary: The study design is a prospective, multi-center, single-arm, non-randomized, and noncontrolled post market clinical follow-up study involving orthopedic surgeons skilled in arthroscopic rotator cuff repair as determined by the Sponsor. conditions: Rotator Cuff Tears conditions: Rotator Cuff Injuries studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 170 type: ESTIMATED name: Tapestry Biointegrative Implant measure: Re-tear rate after arthroscopic rotator cuff repair measure: The American Shoulder and Elbow Surgeons (ASES) Score measure: Constant-Murley Score (CMS) measure: The Single Assessment Numeric Evaluation (SANE) Score measure: EQ-5D-5L (EuroQol) measure: Return to Work/Activity measure: Patient Satisfaction measure: Adverse Event measure: MRI Sugaya Classification measure: MRI Goutallier Classification sex: ALL minimumAge: 21 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06287840 id: 17-301 id: 488294 type: OTHER_GRANT domain: Canadian Institute for Health Research briefTitle: Canadian Bone Strength Development Study acronym: CanBSDS overallStatus: RECRUITING date: 2024-04-01 date: 2028-12-31 date: 2028-12-31 date: 2024-03-01 date: 2024-03-06 name: University of Saskatchewan class: OTHER name: University of Calgary name: The Hospital for Sick Children name: Children's Hospital of Eastern Ontario briefSummary: The goal of this project is to learn about differences in bone development between children with and without type-1 diabetes (T1D). The main questions this study aims to answer are:

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