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<|newrecord|> nctId: NCT06369597 id: Robot2024 briefTitle: A Randomized Controlled Trial of the Safety and Efficacy of Robotic Telesurgery Versus Laparoscopic Surgery overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2024-12-31 date: 2025-03-31 date: 2024-04-17 date: 2024-04-17 name: Sun Yat-sen University class: OTHER briefSummary: This is a randomized controlled trial that will be preceded by a safety trial focusing on the safety and efficacy of robotic telesurgery. The hypothesis is that robotic telesurgery has a non-inferior primary endpoint event rate to local laparoscopic surgery. conditions: Liver Cancer conditions: Renal Cancer conditions: Rectal Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 177 type: ESTIMATED name: Robotic telesurgery name: Laparoscopic surgery measure: Surgical complication measure: Surgical time (min) measure: Intraoperative blood loss (mL) measure: Postoperative hospitalization days measure: Physician satisfaction measure: Remote metrics sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: First Affiliated Hospital, Sun Yat-Sen University city: Guangzhou state: Guangdong zip: 510080 country: China name: Kuang Ming, PhD role: CONTACT phone: 008687755766 phoneExt: 8576 email: kuangm@mail.sysu.edu.cn lat: 23.11667 lon: 113.25 hasResults: False
<|newrecord|> nctId: NCT06369584 id: PEPAD briefTitle: Prone Position During ECMO in Pediatric Patients With Severe ARDS acronym: PEPAD overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-05-01 date: 2025-07-01 date: 2024-04-17 date: 2024-04-17 name: Seventh Medical Center of PLA General Hospital class: OTHER name: Gansu Provincial Maternal and Child Health Care Hospital name: Xian Children's Hospital name: Henan Provincial People's Hospital name: People's Hospital of Guangxi name: Guangdong Provincial People's Hospital briefSummary: In 2023, the second Pediatric Acute Lung Injury Consensus Conference (PALICC-2) updated the diagnostic and management guidelines for Pediatric Acute Respiratory Distress Syndrome (PARDS). The guidelines do not provide sufficient evidence-based recommendations on whether prone positioning ventilation is necessary for severe PARDS patients. However, the effectiveness of Extracorporeal Membrane Oxygenation (ECMO) in treating severe PARDS has been fluctuating around 70% according to recent data from Extracorporeal Life Support Organization (ELSO).
In 2018, the Randomized Evaluation of Sedation Titration for Respiratory Failure (RESTORE) study group conducted a retrospective analysis and concluded that ECMO does not significantly improve survival rates for severe PARDS. However, this retrospective study mainly focused on data from North America, with significant variations in annual ECMO support cases among different centers, which may introduce bias. With advancements in ECMO technology and materials, ECMO has become safer and easier to operate. In recent years, pediatric ECMO support technology has rapidly grown in mainland China and is increasingly being widely used domestically to rescue more children promptly.
ECMO can also serve as a salvage measure for severely ARDS children who have failed conventional mechanical ventilation treatment. When optimizing ventilator parameters (titrating positive end expiratory pressure (PEEP) levels, neuromuscular blockers, prone positioning), strict fluid management alone cannot maintain satisfactory oxygenation (P/F\<80mmHg or Oxygen Index (OI) \>40 for over 4 hours or OI \>20 for over 24 hours), initiating ECMO can achieve lung-protective ventilation strategies with ultra-low tidal volumes to minimize ventilator-associated lung injury. conditions: Pediatric Acute Respiratory Distress Syndrome conditions: Extracorporeal Membrane Oxygenation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 7 type: ESTIMATED name: prone position measure: Mortality measure: Failure of supine position measure: ECMO successful weaning rate measure: Total duration of ECMO Support measure: Number of ECMO-free days measure: Duration of mechanical ventilation days after ECMO successful weaning. measure: Duration of Pediatric Intensive Care Unit (PICU) stay. measure: Duration of hospitalization measure: Incidence of brain injury before discharge measure: Number of days with organ failure measure: Number of days alive without organ failure measure: Number of ventilator assist pneumonia, bacteriemia, and cannula infection episodes measure: Number of days with hemodynamic support with catecholamines measure: Number of days without hemodynamic support with catecholamines sex: ALL minimumAge: 1 Month maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: seventh medical center of Chinese PLA General Hospital city: Beijing state: Beijing zip: 100700 country: China name: Xiaoyang Hong, M.D. role: CONTACT phone: 13311057633 email: jyhongxy@163.com name: Zhe Zhao role: CONTACT phone: 18500179885 email: derekpicu@outlook.com lat: 39.9075 lon: 116.39723 facility: Gansu Provincial Maternal and Child Health Care Hospital city: Lanzhou state: Gansu zip: 730050 country: China name: Weikai Wang, M.D. role: CONTACT phone: 0931-5188650 email: 35487284@qq.com lat: 36.05701 lon: 103.83987 facility: The Second School of Clinical Medicine, Southern Medical University city: Guangzhou state: Guangdong country: China name: Yuxiong Guo, M.D. role: CONTACT phone: 13423661583 email: 2003kellylaw@163.com lat: 23.11667 lon: 113.25 facility: The People's Hospital of Guangxi Zhuang Autonomous Region city: Nanning state: Guangxi country: China name: Hanwu Huang, M.D. role: CONTACT phone: 15107710327 email: 2503133021@qq.com lat: 22.81667 lon: 108.31667 facility: Henan Children's Hospital city: Zhengzhou state: Henan zip: 450014 country: China name: Feng Wang, M.D. role: CONTACT phone: 0371-85515892 email: wang.f365@163.com lat: 34.75778 lon: 113.64861 facility: Henan Provincial People's Hospital city: Zhengzhou state: Henan zip: 463599 country: China lat: 34.75778 lon: 113.64861 facility: Xi'an Children's Hospital city: Xi'an state: Shaanxi zip: 710002 country: China name: Yi Wang, M.D. role: CONTACT phone: 18591953652 email: wangyichengxian@163.com lat: 34.25833 lon: 108.92861 hasResults: False
<|newrecord|> nctId: NCT06369571 id: IRB00439268 briefTitle: Improving Cardiovascular Health Risks in Adults With Epilepsy on a Modified Atkins Diet overallStatus: NOT_YET_RECRUITING date: 2024-07 date: 2027-01 date: 2027-12 date: 2024-04-17 date: 2024-04-17 name: Johns Hopkins University class: OTHER name: American Heart Association briefSummary: Ketogenic diet therapies (KDTs) emphasize high fat and very low carbohydrate intake and help to control seizures in adults who fail to respond to medications. However, KDT use can lead to increased cholesterol levels in some adults with epilepsy (AWE). Treatments that can reverse elevations in cholesterol observed with long-term KDT use without compromising diet adherence and seizure control are needed. The proposed study will explore the feasibility and safety of diet modification and statin use to lower cholesterol in this population. Study findings will help guide doctors utilizing KDTs in adults with epilepsy on how to approach managing elevations in cholesterol. conditions: Epilepsy conditions: Dyslipidemia studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 22 type: ESTIMATED name: Atorvastatin 10mg name: Modification of dietary fat composition measure: Diet adherence as assessed by 3 day food records measure: Statin Adherence measure: LDL Change measure: Change in weekly seizure frequency measure: Seizure severity questionnaire score measure: Frequency of adverse events measure: Blood ketone change sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<|newrecord|> nctId: NCT06369558 id: BiruniUniversi briefTitle: Plyometric Exercise Training in Athletes With Chronic Low Back Pain overallStatus: COMPLETED date: 2024-01-01 date: 2024-04-04 date: 2024-04-04 date: 2024-04-17 date: 2024-04-17 name: Ugur Cavlak class: OTHER name: Biruni University briefSummary: The aim of this study is to examine the effectiveness of plyometric exercise training in the athletes with chronic low back pain. 32 professional volunteer athletes participated in the study. conditions: Low Back Pain, Mechanical studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized controlled trial primaryPurpose: TREATMENT masking: NONE count: 32 type: ACTUAL name: PLYOMETRIC TRAINING name: CLASSIC PHYSIOTHERAPY PROGRAM measure: VISUAL ANALOG SCALE measure: OSWESTRY DISABILITY INDEX measure: SIT AND REACH TEST measure: VERTICAL JUMP TEST measure: FLAMINGO BALANCE TEST measure: SHUTTLE RUNNİNG (20 MİN.) measure: MANUAL MUSCLE STRENGTH TEST sex: ALL minimumAge: 18 Years maximumAge: 25 Years stdAges: ADULT facility: Faculty of Health Sciences in Biruni University city: İ̇stanbul state: Zeytinburnu zip: 34010 country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False
<|newrecord|> nctId: NCT06369545 id: BiruniUniver briefTitle: Chronic Pelvic Pain Syndrome in Males overallStatus: RECRUITING date: 2024-01-01 date: 2024-04-04 date: 2024-08-15 date: 2024-04-17 date: 2024-04-17 name: Biruni University class: OTHER briefSummary: The aim of this study is to evaluate the effectiveness of ESWT (Extracorporeal Shock Wave Therapy) and TENS (Transcutaneous Electrical Nerve Stimulation) in individuals diagnosed with chronic pelvic pain syndrome and treated with medication. The study was organized as a randomized controlled trial. The sample size is 30 patients suffering from chronic pelvic pain syndrome. conditions: Pelvic Pain Syndrome studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized Controled Trial primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 38 type: ESTIMATED name: EXERCISE name: TENS name: ESWT measure: VISUAL ANALOUGE SCALE measure: National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) measure: ALGOMETER measure: Hospital Anxiety and Depression Scale- HAD measure: Nottingham Health Profile-NHP measure: Digital Muscle Testing measure: Flexibility Measurements measure: ROM Assessments measure: Lasegue Test sex: MALE minimumAge: 20 Years maximumAge: 40 Years stdAges: ADULT facility: Faculty of Health Sciences in Biruni University status: RECRUITING city: İ̇stanbul state: Zeytinburnu zip: 34010 country: Turkey name: UGUR CAVLAK, Prof., PhD. role: CONTACT phone: 00905324519644 email: ucavlak@biruni.edu.tr lat: 41.01384 lon: 28.94966 hasResults: False
<|newrecord|> nctId: NCT06369532 id: ONZ-2023-0460 briefTitle: Combination of Neurostimulation and Psychotherapy to Stop Worrying overallStatus: RECRUITING date: 2024-03-06 date: 2026-02-20 date: 2027-02-20 date: 2024-04-17 date: 2024-04-17 name: University Hospital, Ghent class: OTHER briefSummary: This study aims to investigate whether the combination of transcranial Direct Current Stimulation (tDCS) and cognitive-behavioral therapy (CBT) is more effective for treating repetitive negative thinking (RNT) in patients with the symptom of high rumination. High ruminators will be included (Group1, active tDCS-CBT group; Group2, sham tDCS-CBT group). All patients will receive active or sham tDCS. conditions: Active tDCS conditions: Sham tDCS studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: Participants will be allocated into two groups randomly (using a code). The psychotherapist, the study managers and the patients will not be aware of treatment allocation. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 85 type: ESTIMATED name: Active tDCS name: Sham tDCS measure: the therapeutic effect of the combination therapy for repetitive negative thinking measure: the consolidation effect of tDCS on CBT measure: Change of neuroimaging data sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital Ghent status: RECRUITING city: Ghent state: East-Flanders zip: 9000 country: Belgium name: Chris Baeken, Prof. role: CONTACT name: Josefien Dedoncker, M.Sc. role: CONTACT lat: 51.05 lon: 3.71667 hasResults: False
<|newrecord|> nctId: NCT06369519 id: 2023#17-23 briefTitle: Optimization of Management for Sporadic Bilateral Renal Cell Carcinoma overallStatus: COMPLETED date: 2000-01-01 date: 2020-12-31 date: 2020-12-31 date: 2024-04-17 date: 2024-04-17 name: Peking University First Hospital class: OTHER briefSummary: Sporadic bilateral renal cell carcinoma (BRCC) is a rare situation of RCC. The treatment for BRCC is controversial and there is a lack of authoritative guidelines about the management of BRCC. The goal of this cohort study is to identify prognostic factors, construct predictive nomograms, and optimize management for sporadic BRCC patients. The main questions it aims to answer are:
What are the factors influencing the prognosis of BRCC patients? What's the appropriate treatment for BRCC patients?
Researchers will analysis the prognostic factors and compare the prognosis of BRCC patients receiving different treatments. conditions: Kidney Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 3677 type: ACTUAL name: Surgery treatment or local tumor destruction. measure: Overall survival (OS) measure: Cancer-specific survival (CSS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Peking University First Hospital city: Beijing state: Beijing zip: 100034 country: China lat: 39.9075 lon: 116.39723 hasResults: False
<|newrecord|> nctId: NCT06369506 id: PYO.DIS.1904 Protocol ID:4467 briefTitle: Evaluation of Gingival Thickness Measurement at Different Anatomical Landmarks overallStatus: COMPLETED date: 2022-09-10 date: 2023-08-05 date: 2023-12-17 date: 2024-04-17 date: 2024-04-17 name: Ondokuz Mayıs University class: OTHER briefSummary: In this study, the point at which gingival thickness (GT) should be measured was investigated. Measurements were made from three different points. It was classified as thin and thick in two ways, according to the average of these three different points and the point corresponding to the base of the gingival groove, which is frequently used in the literature. And these two classifications were compared. conditions: Gingival Thickness studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants were divided into two different classifications: "thin" and "thick". The first classification was made by measuring the GT of the point corresponding to the base of the gingival sulcus. GT was defined as thin if ≤1 mm, and thick if \>1 mm. In the second classification, GT was measured from three different points. And according to the average GT of three points, they were equally classified as "thin" and "thick". primaryPurpose: SCREENING masking: NONE count: 50 type: ACTUAL name: GTmeasurement measure: Examining the sensitivities and sensitivities of two different gingival phenotype classifications based on three-point average GT measurement and single-point measurement using Receiver Operating Characteristic Analysis (ROC). measure: Examining the agreement of GT measurements at three different points in 50 patients, 1195 teeth, using Kappa analysis. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ondokuz Mayis University Faculty of Dentistry Department of Periodontology city: Samsun zip: 55000 country: Turkey lat: 41.27976 lon: 36.3361 hasResults: False
<|newrecord|> nctId: NCT06369493 id: OMUKAEK: 2022/210 briefTitle: Examining The Relationship Between Gingival Thickness and Tooth and Gingival Parameters overallStatus: COMPLETED date: 2022-09-01 date: 2023-12-01 date: 2023-12-18 date: 2024-04-17 date: 2024-04-17 name: Ondokuz Mayıs University class: OTHER briefSummary: This study aims to assess whether there is a valid correlation between the identified multiple clinical and morphometric parameters and the gingival thickness. conditions: Gingival Thickness studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 50 type: ACTUAL measure: Evaluation of the correlation between KGW, CW, CL PH parameters of GT measured in "mm" with a digital caliper with 0.001 mm precision in 1200 teeth in 50 participants using Spearman correlation analysis. measure: Evaluation of the effect of GT on keratinized gingival width, measured in "mm" by digital caliper with a precision of 0.001 mm, both by binary logistic regression analysis of 50 participants. measure: Examining the effect of age and gender of 50 participants on the gingival thickness measured in mm using binary logistic regression analysis. measure: Evaluation of researcher reliability by ICC (Intra-Class Correlation Coefficient) in 10 participants in 2 weeks sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ondokuz Mayis University Faculty of Dentistry Department of Periodonthology city: Samsun zip: 55200 country: Turkey lat: 41.27976 lon: 36.3361 hasResults: False
<|newrecord|> nctId: NCT06369480 id: Journal-nr.: R-23057752 briefTitle: Prognostic Factors for Survival in Patients With Cholangiocarcinoma overallStatus: RECRUITING date: 2024-02-01 date: 2024-08-31 date: 2024-08-31 date: 2024-04-17 date: 2024-04-17 name: Rigshospitalet, Denmark class: OTHER briefSummary: The objective of this retrospective study is to determine the survival rates of CCA patients based on different therapeutic approaches. Additionally, we aim to investigate the risk factors associated with poor survival within a cohort of patients treated over a seven-year period across four Danish hospitals. We anticipate that our findings could provide additional evidence for clinical decision-making, improve patient outcomes, and contribute to the knowledge in the field. conditions: Cholangiocarcinoma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 2000 type: ESTIMATED name: Resection/Ablation of tumor name: Palliative chemotherapy name: Neoadjuvant chemotherapy name: Stereotatic radiotherapy name: Best supportive care measure: Aim I measure: Aim II sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Rigshospitalet status: RECRUITING city: Copenhagen zip: 2100 country: Denmark name: Hans-Christian Pommergaard, MD DMSc PhD role: CONTACT email: hans-christian.pommergaard@regionh.dk lat: 55.67594 lon: 12.56553 hasResults: False
<|newrecord|> nctId: NCT06369467 id: R5458-668-ALG-2219 id: 2024-511032-27-00 type: REGISTRY domain: EU CT Number briefTitle: Short-Term Linvoseltamab Treatment, on Top of Chronic Dupilumab Treatment, for Adults With Severe Immunoglobulin E (IgE)-Mediated Food Allergy overallStatus: NOT_YET_RECRUITING date: 2024-04-12 date: 2026-04-24 date: 2026-04-24 date: 2024-04-17 date: 2024-04-17 name: Regeneron Pharmaceuticals class: INDUSTRY briefSummary: This study is researching an experimental drug called linvoseltamab when combined with another drug called dupilumab. The study is focused on patients who have IgE-mediated food allergy. If the patient has an allergy, the immune system overreacts to an allergen (eg, certain foods such as peanuts, milk, shellfish) by producing antibodies called IgE. IgE antibodies are released by cells such as plasma cells. These antibodies and allergen bind to other cells that release chemicals, causing an allergic reaction. The aim of the study is to see how safe and tolerable linvoseltamab is when combined with dupilumab.
The study is looking at several other research questions, including:
* What side effects may happen from taking the study drugs
* Whether linvoseltamab when combined with dupilumab has an effect on other types of antibodies in the blood at different times
* How much study drug(s) is in the blood at different times conditions: Food Allergy studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 6 type: ESTIMATED name: linvoseltamab name: dupilumab measure: Incidence of treatment-emergent adverse events (TEAEs) measure: Severity of TEAEs measure: Incidence of adverse event of special interest (AESIs) measure: Severity of AESIs measure: Incidence of serious adverse events (SAEs) measure: Severity of SAEs measure: Absolute change in the serum concentration of total IgE over time measure: Percent change in the serum concentration of total IgE over time measure: Time to reach unquantifiable total serum IgE concentration measure: Time to reach baseline level and/or the lower limit of the normal ranges of serum IgG measure: Time to reach baseline level and/or the lower limit of the normal ranges of serum immunoglobulin M (IgM) measure: Time to reach baseline level and/or the lower limit of the normal ranges of serum immunoglobulin A (IgA) measure: Incidence of participants with unquantifiable concentrations of serum total IgE measure: Absolute change in the serum concentration of food allergen-specific IgE measure: Percent change in the serum concentration of food allergen-specific IgE measure: Time to reach unquantifiable food allergen-specific serum IgE levels sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT hasResults: False
<|newrecord|> nctId: NCT06369454 id: B7981090 briefTitle: A Study to Learn About How Different Forms of the Study Medicine Called Ritlecitinib Pass the Intestines of Healthy Male Adults When Taken With or Without Food overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-08-03 date: 2024-08-03 date: 2024-04-17 date: 2024-04-17 name: Pfizer class: INDUSTRY briefSummary: The purpose of this study is to learn about how different forms of the study medicine called ritlecitinib pass the intestines of healthy male adults when taken with or without food.
This study is seeking healthy participants who have:
* Aged 18 years or older;
* male who are healthy as determined by medical assessment;
* BMI of 16-32 kg/m2, and a total body weight \>45 kg (99 lb).
All participants in this study will receive a ritlecitinib oral dose in two different forms (solution without food, capsule with or without food).
The study will take up to 3 months, including the screening period and follow-up phone call. Participants will have to stay at the study clinic for at least 11 days. There will be 3 periods in total, and a washout period of at least 3 days between dosings in Period 1 and Period 2, and at least 7 days between dosings in Period 2 and Period 3 for this study. On day 1 of each period, participants will take one form of Riltecitinib without food for the first two periods and with food for the last period. Participants will have blood samples taken both before and after taking ritlecitinib. A follow-up phone call will be made at 28 to 35 days after the last study period. conditions: Healthy Volunteers studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: BASIC_SCIENCE masking: NONE count: 12 type: ESTIMATED name: Ritlecitinib measure: Site of capsule disintegration and MR microsphere dispersion measure: Gastric emptying time measure: Small intestine residence/transit time measure: Colon arrival time measure: Colon (ascending, transverse, descending) residence/transit time measure: Total transit time measure: Maximum plasma concentration (Cmax) measure: Area under the plasma concentration-time profile from time zero extrapolated to infinite time (AUCinf) measure: Area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration (AUClast) measure: Time for Cmax (Tmax) measure: Terminal half-life (t1/2) measure: Frequency of adverse events measure: Frequency of abnormal clinical laboratory tests measure: Frequency of abnormal vital signs measure: Frequency of abnormal 12-lead ECG sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<|newrecord|> nctId: NCT06369441 id: Ovation-23-001 briefTitle: Collection of Biological Specimens and Associated Health Information overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-04 date: 2034-04 date: 2024-04-17 date: 2024-04-17 name: Ovation.io, Inc. class: INDUSTRY briefSummary: The purpose of this study is to collect blood samples from a large number of individuals with cancer to create a database for researchers to use in future studies. Researchers may use this database to discover new ways to detect and treat cancer and other diseases. Future studies may use stored blood samples to discover how genes affect health and disease. conditions: Cancer conditions: Other Disease studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 10000 type: ESTIMATED measure: Biorepository sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ovation.io city: Portland state: Maine zip: 04101 country: United States name: Stephanie Balcaitis role: CONTACT phone: 617-795-4947 phoneExt: 2 email: ClinicalAffairs@ovation.io name: Ed Stepanski, PhD role: CONTACT email: ClinicalAffairs@ovation.io name: Pauline Gee, PhD role: PRINCIPAL_INVESTIGATOR lat: 43.66147 lon: -70.25533 hasResults: False
<|newrecord|> nctId: NCT06369428 id: CDRB436BFI02 briefTitle: Patient Characteristics, Treatment Patterns, and Healthcare Resource Utilization of Metastatic Melanoma Patients overallStatus: COMPLETED date: 2021-06-23 date: 2023-04-13 date: 2023-04-13 date: 2024-04-17 date: 2024-04-17 name: Novartis class: INDUSTRY briefSummary: This was a retrospective, non-interventional, registry study based on secondary electronic medical record (EMR) data collected in Helsinki and Uusimaa hospital district (HUS data lake), hospital district of Southwest Finland (VSSHP data lake) and Pirkanmaa hospital district (PSHP data lake) as a part of their routine clinical practice. Social Insurance Institution of Finland (SII; reimbursed drug purchases) was utilized in this study to complement the medication data. The metastatic melanoma patients were stratified by first-line treatment and by hospital district. conditions: Metastatic Melanoma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 1795 type: ACTUAL measure: Mean Age-standardized Annual Incidence of Metastatic Melanoma in 2014-2021 measure: Point Prevalence per 100,000 Population measure: Mean Age of Patients at Index Date per Hospital District measure: Mean Length of Follow-up at Index Date per Hospital District measure: Gender at Index Date per Hospital District measure: Number of Patients with Lactate Dehydrogenase (LDH) Levels Less than the Upper Limit of Normal (ULN) at Index Date per Hospital District measure: Number of Patients with LDH Levels Between the ULN and 1.5 Times ULN at Index Date per Hospital District measure: Number of Patients with LDH Levels Greater than 1.5 Times ULN at Index Date per Hospital District measure: Number of Patients with Positive Proto-oncogene B-Raf (BRAF) Status at Index Date per Hospital District measure: Number of Patients with Negative BRAF Status at Index Date per Hospital District measure: Number of Patients by Charlson Comorbidity Index (CCI) Score Category at Index Date per Hospital District measure: Number of Patients by Number of Metastatic Organs at Index Date per Hospital District measure: Number of Patients by Location of Metastases at Index Date per Hospital District measure: Number of Patients by Tumor, Nodes, and Metastasis (TNM) Stage per Hospital District measure: Number of Patients by Most Prevalent (greater than 5%) Baseline Comorbidities per First-line Medication measure: Overall Survival (OS) measure: Time to Next Treatment (TTNT) of the First-line (1L) by Type of Treatment measure: Duration of Treatment (DoT) measure: Mean Age at Index Date per First-line (1L) Medication measure: Length of Follow-up at Index Date per 1L Medication measure: Time to Treatment at Index Date per 1L Medication measure: Gender at Index Date per 1L Medication measure: Number of Patients with Lactate Dehydrogenase (LDH) Levels Less than the Upper Limit of Normal (ULN) at Index Date per 1L Medication measure: Number of Patients with LDH Levels Between the ULN and 1.5 Times ULN at Index Date per 1L Medication measure: Number of Patients with LDH Levels Greater than 1.5 Times ULN at Index Date per 1L Medication measure: Number of Patients with Positive Proto-oncogene B-Raf (BRAF) Status at Index Date per 1L Medication measure: Number of Patients with Negative BRAF Status at Index Date per 1L Medication measure: Number of Patients by Charlson Comorbidity Index (CCI) Score Category at Index Date per 1L Medication measure: Number of Patients by Number of Metastatic Organs at Index Date per 1L Medication measure: Number of Patients by Location of Metastases at Index Date per 1L Medication measure: Number of Patients by Tumor, Nodes, and Metastasis (TNM) Stage per 1L Medication measure: Number of Patients that Received Radiotherapy During 1L Treatment measure: Number of Patients Switched from Immuno-oncology (IO) 1L Treatment to Targeted Therapy (TT) Second-line (2L) Treatment measure: Number of Patients Switched from IO 1L Treatment to Chemotherapy (Chemo) 2L Treatment measure: Number of Patients Switched from TT 1L Treatment to IO 2L Treatment measure: Number of Patients Switched from TT 1L Treatment to Chemo 2L Treatment measure: Number of Patients Switched from Chemo 1L Treatment to IO 2L Treatment measure: Number of Patients Switched from Chemo 1L Treatment to TT 2L Treatment measure: Number of Patients Switched from IO 2L Treatment to TT Third-line (3L) Treatment measure: Number of Patients Switched from IO 2L Treatment to Chemo 3L Treatment measure: Number of Patients Switched from TT 2L Treatment to IO 3L Treatment measure: Number of Patients Switched from TT 2L Treatment to Chemo 3L Treatment measure: Number of Patients Switched from Chemo 2L Treatment to IO 3L Treatment measure: Number of Patients Switched from Chemo 2L Treatment to TT 3L Treatment measure: Number of Healthcare Contacts and Associated Costs per Patient Year measure: Number of Healthcare Contacts and Associated Costs per Patient measure: Number of Healthcare Contacts and Associated Total Costs sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Novartis city: Basel zip: 4056 country: Switzerland lat: 47.55839 lon: 7.57327 hasResults: False
<|newrecord|> nctId: NCT06369415 id: 04/24/DD-BVMD briefTitle: Health of Babies Born From IVF Versus IVM at 5 Years Old acronym: FM-BABIES-5Y overallStatus: RECRUITING date: 2024-04-16 date: 2025-12-30 date: 2026-03-30 date: 2024-04-17 date: 2024-04-17 name: Mỹ Đức Hospital class: OTHER briefSummary: The investigators conduct a long-term follow-up at five years on offspring born from our randomized controlled trial (RCT) to investigate whether or not there is any difference in developmental outcomes in children born after capacitation IVM (CAPA IVM) compared with conventional IVF in order to give strong evidence about the safety of IVM in women with high antral follicle count. conditions: Infertility conditions: IVF conditions: IVM conditions: Development, Child studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 231 type: ESTIMATED name: Developmental score according to The Ages & Stages Questionnaires®, Third Edition - ASQ®-3 and behavioural screening according to Strength and Difficulties Questionnaires (SDQ's) measure: Normal ASQ-3 score rate. measure: Normal SDQ score rate. measure: Normal weight rate measure: Thinness rate measure: Overweight rate measure: Obesity rate measure: Score of Communication (ASQ-3 questionnaire) measure: Score of Gross motor (ASQ-3 questionnaire) measure: Score of Fine motor (ASQ-3 questionnaire) measure: Score of Problem solving (ASQ-3 questionnaire) measure: Score of Personal-Social (ASQ-3 questionnaire) measure: Score of Emotional symptoms (SDQ questionnaire) measure: Score of Conduct problems (SDQ questionnaire) measure: Score of hyperactivity/inattention (SDQ questionnaire) measure: Score of peer relationship problems (SDQ questionnaire) measure: Score of prosocial behavior (SDQ questionnaire) measure: The total difficulties score. sex: ALL minimumAge: 5 Years maximumAge: 5 Years stdAges: CHILD facility: Mỹ Đức Hospital status: RECRUITING city: Ho Chi Minh City state: Tan Binh country: Vietnam name: Tuong M Ho, MD, MCE role: CONTACT phone: +84903633377 email: tuongho.ivfmd@gmail.com lat: 10.82302 lon: 106.62965 hasResults: False
<|newrecord|> nctId: NCT06369402 id: 0963 briefTitle: Cognitive Impairment and Cerebral Haemodynamics in Individuals With Symptomatic Peripheral Arterial Disease acronym: CInCH PAD overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-02 date: 2025-02 date: 2024-04-17 date: 2024-04-25 name: University of Leicester class: OTHER name: University Hospitals, Leicester briefSummary: Background:
Arterial disease of the legs causes symptoms such as pain when walking and may ultimately lead to a leg amputation. Many older people with arterial disease of the legs also have problems with their thinking and memory. Blood flow in the brain may be altered in these people and may be a cause for memory and thinking problems.
Aim:
The aim of this project is to investigate whether people with arterial disease of the legs have altered blood flow in the brain causing problems with memory and thinking.
Research plan:
Twenty people with arterial disease of the legs causing pain while walking and twenty healthy people will have a series of non-invasive assessments. Arterial disease in the legs will be measured using ankle blood pressures before and after walking. Blood flow in the brain will be measured using ultrasound whilst performing memory and thinking tests. Results will be compared between the people with arterial disease in the legs and the healthy people to see if there are any differences in blood flow to the brain and memory and thinking.
Benefits to society:
This project will help determine if there is a link between arterial disease of the legs and memory and thinking problems caused by altered blood flow in the brain. It will enable future research in people with cognitive impairment caused by altered blood supply to the brain and to prevent confusion and further memory and thinking problems in people undergoing surgery for arterial disease of the legs. conditions: Peripheral Arterial Disease conditions: Cognitive Impairment studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 40 type: ESTIMATED name: Cerebral haemodynamic testing using transcranial Doppler name: Ankle-brachial pressure index name: Six-minute walk test measure: Peak % change of CBv from baseline measure: Autoregulation index (Tieck's model) measure: Absolute score achieved on the Addenboook's cognitive examination (III) measure: Digit span forward and backward scores measure: Claudication distance measure: Maximal walking distance measure: Ankle-brachial pressure index sex: ALL minimumAge: 50 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Glenfield Hospital Leicester city: Leicester state: Leicestershire zip: LE3 9QP country: United Kingdom lat: 52.6386 lon: -1.13169 hasResults: False
<|newrecord|> nctId: NCT06369389 id: RC31/23-0417 briefTitle: Real-life Management of Patients Eligible for CAR-T Cell Therapy acronym: CARAVAGE overallStatus: NOT_YET_RECRUITING date: 2024-04-30 date: 2033-12-31 date: 2034-12-31 date: 2024-04-17 date: 2024-04-17 name: University Hospital, Toulouse class: OTHER name: Ligue contre le cancer, France name: Janssen, LP briefSummary: Adoptive immunotherapy using CAR-T cells is now one of the Advanced Therapy Medicines routinely used for relapsed or refractory lymphoid hemopathies. In 2023, in France, 5 types of CAR-T cells have marketing authorization for 6 different indications. However, these marketing authorizations are based on clinical trials involving a limited number of selected patients. Real-life data are essential for assessing the post-authorization use of these innovative treatments. The French national DESCAR-T registry, promoted by LYSARC and in which Toulouse University Hospital plays an active role, is an international reference for this real-life evaluation. It does not, however, allow precise evaluation of patient-centered indicators and care pathways.
With the increasing number of indications and candidate patients, Toulouse University Hospital, the only healthcare facility authorized in the Western Occitanie region to administer CAR-T cells, is faced with growing hospital needs and longer treatment times. In 2023, this has necessitated the implementation of new ambulatory and inter-facility care pathways in collaboration with the referral centers of the Onco-Occitanie Ouest regional cancer network. The selection of patients for CAR-T cell treatment is based on objective clinical criteria linked to the pathology (histology, morphological localization, size and kinetics of the tumor mass) and the patient (physiological age, performance index, comorbidities, patient choice). Because of their innovative nature, in a difficult psychological and physical context for the patient (refractory disease), CAR-T cell care pathways also need to be evaluated in terms of their "quality of life" dimension. The impact of non-biological determinants (also described as social and territorial inequalities in health) such as place of residence and distance from healthcare provision, marital, economic and social status, has never been explored on the accessibility and progress of the CAR-T cell treatment pathway.
The creation of a registry of patients eligible for CAR-T cells at Toulouse University Hospital will enable these lines of research to be explored on the scale of a region with a population of 3 million. conditions: Hemopathy studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 550 type: ESTIMATED name: Patients eligible for CAR-T treatment measure: Overall survival of patients with hemopathy eligible for CAR-T cell therapy measure: Compare progression-free survival and overall survival of patients according to care pathway and type of hemopathy, and investigate clinical and socioeconomic factors associated with better survival measure: Evaluate the time taken to treat patients with CAR-T cells sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHU de Toulouse city: Toulouse state: CHU De Toulouse zip: 31059 country: France name: Pierre BORIES, MD role: CONTACT phone: 0531156415 phoneExt: 33 email: bories.pierre@iuct-oncopole.fr name: Sandra DE BARROS role: CONTACT phone: 0561145982 email: debarros.s@chu-toulouse.fr lat: 43.60426 lon: 1.44367 hasResults: False
<|newrecord|> nctId: NCT06369376 id: ONZ-2022-0072 briefTitle: Electrodiagnostic Approach for Pectoral Nerve Conduction Studies overallStatus: COMPLETED date: 2023-06-30 date: 2023-11-29 date: 2024-04-12 date: 2024-04-17 date: 2024-04-17 name: University Hospital, Ghent class: OTHER briefSummary: Anatomical studies have challenged traditional perceptions of the pectoral nerve structure, revealing a network of three branches rather than the previously accepted medial and lateral branches. This study aims to explore the implications of this updated anatomy on nerve conduction studies of the pectoral nerve and proposes a modified nerve conduction study protocol to enhance diagnostic accuracy.
A study on 25 volunteers was conducted, examining the three parts of the pectoral nerve. Electrode placement followed a detailed methodology ensuring precise data collection. The nerve conduction study was performed bilaterally, exploring latency and amplitude while addressing inter-observer variability and demographic influences. conditions: New Nerve Conduction Protocol for Pectoral Nerve studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 25 type: ACTUAL name: New nerve conduction protocol measure: Latency measure: Amplitude sex: ALL minimumAge: 22 Years maximumAge: 68 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UZ Gent city: Gent state: Oost-Vlaanderen zip: 9000 country: Belgium lat: 51.05 lon: 3.71667 hasResults: False
<|newrecord|> nctId: NCT06369363 id: STUDY000024245 briefTitle: Estrogen Deficiency on Cardiovascular Risk overallStatus: NOT_YET_RECRUITING date: 2025-09 date: 2027-09 date: 2027-11 date: 2024-04-17 date: 2024-04-17 name: Milton S. Hershey Medical Center class: OTHER briefSummary: To explore how estrogen deficiency impacts the blood pressure (BP) and sympathetic nerve activity (SNA), and how it impacts the production of the key pro-inflammatory mediators such as Tumor necrosis factor α (TNF-α), interleukin-1β (IL-1β), and interleukin-6 (IL-6). It is hypothesized that estrogen deficiency increases BP, SNA and the pathway activities of the key pro-inflammatory mediators. Those effects are impacted through the downregulation of the estrogen receptor. conditions: Postmenopausal Symptoms conditions: Cardiovascular Diseases studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 20 type: ESTIMATED name: Placebo name: Estradiol measure: Red blood cell flux measure: Mean arterial pressure (mmHg) measure: baseline plasma TNF-α concentration (pg/ml) measure: One week post-intervention plasma TNF-α concentration (pg/ml) measure: baseline plasma IL-1β concentration (pg/ml) measure: One week post-intervention plasma IL-1β concentration (pg/ml) measure: baseline plasma IL-6 concentration (pg/ml) measure: One week post-intervention plasma IL-6 concentration (pg/ml) measure: baseline plasma estrogen (pg/ml) measure: One week post-intervention plasma estrogen (pg/ml) sex: FEMALE minimumAge: 54 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<|newrecord|> nctId: NCT06369350 id: STUDY000020217 id: 940567 type: OTHER_GRANT domain: American Heart Association briefTitle: Vitamin B6 on Exercise Pressor Reflex on Leg Ischemia-reperfusion overallStatus: NOT_YET_RECRUITING date: 2024-09 date: 2025-09 date: 2025-09 date: 2024-04-17 date: 2024-04-17 name: Milton S. Hershey Medical Center class: OTHER name: American Heart Association briefSummary: In this study, we are trying to see if vitamin B6 can minimize the amplified blood pressure response to exercise following ischemia-reperfusion injury. We are interested in a protein called P2X3, of which function can be blocked by vitamin B6, in the neurons of our nervous system. It is very important for blood pressure regulation. We would like to see if the P2X3 plays a role in patients' rising blood pressure during exercise. The results of the proposed studies will provide a base for those two potential economic and non-invasive inventions to improve the overall health and well-being of PAD patients. conditions: Ischemia Reperfusion Injury conditions: Peripheral Artery Disease studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: Vitamin B6 25 MG name: Vitamin B6 50 MG name: Vitamin B6 100 MG name: Placebo measure: baseline blood pressure in mmHg measure: Second visit blood pressure in mmHg measure: baseline heart Rate in beats per minute measure: Second visit heart Rate in beats per minute measure: baseline muscle sympathetic nerve activity in burst/min measure: Second visit muscle sympathetic nerve activity in burst/min measure: baseline walking time in minutes measure: Second visit walking time in minutes sex: ALL minimumAge: 21 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<|newrecord|> nctId: NCT06369337 id: 014-24 briefTitle: Ultrasound Study of the Submentonian Musculature and Its Relationship in Dysphagia overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-04 date: 2025-06 date: 2024-04-17 date: 2024-04-22 name: Universidad Europea de Madrid class: OTHER name: Hospital Universitario Ramon y Cajal briefSummary: Acquired dysphagia is one of the most frequent complications suffered by patients in intensive care units (ICU) after orotracheal extubation. Ultrasound has proven to be a useful method in the morphological and kinematic exploration of the main swallowing structures. AIM: to evaluate, through ultrasound procedures, the evolution of the morphology of the tongue and muscles of the floor of the mouth and the hyolaryngeal kinematics in patients intubated \>48h and to correlate these measurements with the possible development of acquired dysphagia. The incidence of dysphagia and ICU acquired weakness (ICUAW) in subjects with \>48h of intubation and the relative risk factors associated with baseline characteristics and clinical variables will be described. METHODOLOGY: Design: Single-center cohort study (Ramón y Cajal University Hospital). Participants: subjects \>18 years old, admitted to an intensive care unit (ICU), with \>48 hours of orotracheal intubation who meet eligibility criteria. Outcomes: the study of socio-demographic and clinical variables related to ICU admission will be included. The physical function variables will be analyzed through the Medical Research Council (MRC) and Functional Status Score (FSS), as well as swallowing function variables through the Volume-Viscosity Swallow (VVS-T) and Functional Oral Intake Scale scales. (FOIS) and Gugging Swallowing Screen (GUSS). Measurements will be made of the thickness and echogenicity of the submental and tongue muscles, as well as hyolaryngeal kinematics conditions: Dysphagia, Oropharyngeal conditions: Deglutition Disorders conditions: Mechanical Ventilation Complication studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 150 type: ESTIMATED name: Ultrasound measure: Thickness of the submental muscles measure: Hyolaryngeal displacement measure: Muscle strength measure: Functional Status measure: Swallowing function measure: Swallowing function measure: Swallowing function sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<|newrecord|> nctId: NCT06369324 id: 05 briefTitle: Efficacy of Pain Neuroscience Education and Physiotherapy in Patients Diagnosed With Spondyloarthritis overallStatus: RECRUITING date: 2024-02-15 date: 2024-04-11 date: 2024-04-11 date: 2024-04-17 date: 2024-04-18 name: Universidad de Extremadura class: OTHER briefSummary: Spondyloarthritis, notably ankylosing spondylitis (AS), represents a chronic rheumatic condition typified by persistent back pain and stiffness. It constitutes a substantial portion of diagnoses within rheumatology units and exhibits a higher prevalence among males. Diagnosis relies upon comprehensive clinical evaluation, including patient history, physical examination, and adjunctive radiological assessments, with genetic predisposition, particularly the presence of the HLA-B27 antigen, playing a significant role.
Management strategies encompass a multidisciplinary approach, with physiotherapy emerging as a cornerstone therapeutic modality. Various exercise interventions, particularly those supervised by trained professionals, demonstrate efficacy in improving pain, stiffness, and overall functional capacity. Furthermore, patient education plays a pivotal role in enhancing treatment adherence and optimizing outcomes by aligning patient expectations with therapeutic goals.
The evolving landscape of spondyloarthritis management underscores the necessity of further research into multimodal treatment approaches, particularly in integrating novel interventions such as electrophysical agents. By elucidating the mechanisms of action and exploring their synergistic effects, clinicians can refine treatment protocols and ultimately enhance the quality of care provided to individuals living with spondyloarthritis. conditions: Spondyloarthropathies conditions: Ankylosing Spondylitis conditions: Exercise Therapy conditions: Physical Therapy Modalities conditions: Pain Management studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Pain education name: Exercise supervised by external focus name: Therapy by means of electrical stimulation (electro-massage) measure: Numeric Pain Rating Scale (NPRS) measure: Cervical and Lumbar Joint Position Sense Error measure: Cervical Range of Motion (CRoM) measure: Pressure Pain Threshold (PPT) measure: Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) measure: Bath Ankylosing Spondylitis Motility Index (BASMI) measure: Bath Ankylosing Spondylitis Functional Index (BASFI). measure: Kinesophobia measure: Catastrophizing Pain measure: Fear-Avoidance Beliefs Questionnaire (FABQ) sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Faculty of Medicine and Health Sciences status: RECRUITING city: Badajoz zip: 06006 country: Spain name: Carlos Fernández-Morales, MSc role: CONTACT lat: 38.87789 lon: -6.97061 hasResults: False
<|newrecord|> nctId: NCT06369311 id: 2000037345 briefTitle: [Trial of device that is not approved or cleared by the U.S. FDA] overallStatus: WITHHELD date: 2024-04-17 date: 2024-04-17 name: [Redacted] hasResults: False
<|newrecord|> nctId: NCT06369298 id: JK07.2.01 briefTitle: Study of JK07 in Patients With Chronic Heart Failure acronym: RENEU-HF overallStatus: RECRUITING date: 2024-03-28 date: 2025-12-31 date: 2026-06-30 date: 2024-04-16 date: 2024-04-18 name: Salubris Biotherapeutics Inc class: INDUSTRY briefSummary: This is a Phase 2, randomized, double-blind, placebo-controlled, multiple dose study to assess the safety, tolerability, and efficacy of JK07 in participants aged 18-85 with heart failure.
There will be 2 cohorts in this study:
Cohort 1: Heart failure (HF) participants with left ventricular ejection fraction (LVEF) of ≤ 40%.
Cohort 2: Heart failure (HF) participants with left ventricular ejection fraction (LVEF) \> 40% and ≤ 65%.
Participants in both cohorts will be randomized into either low dose JK07, high dose JK07 or placebo. Participants will have a 2:1 chance of receiving JK07 versus placebo. conditions: Heart Failure With Reduced Ejection Fraction conditions: Heart Failure With Preserved Ejection Fraction studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 282 type: ESTIMATED name: JK07 name: Placebo measure: Safety - Cohort 1 measure: Efficacy - Cohort 1 measure: Safety - Cohort 2 sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Southern California Heart Specialists status: RECRUITING city: Pasadena state: California zip: 91105 country: United States name: Gregory Giesler role: CONTACT lat: 34.14778 lon: -118.14452 facility: New Generation of Medical Research status: RECRUITING city: Hialeah state: Florida zip: 33016 country: United States name: Karelia Ruiz role: CONTACT lat: 25.8576 lon: -80.27811 facility: Louisiana Heart Center status: RECRUITING city: Covington state: Louisiana zip: 70433 country: United States name: Bruce Iteld, MD role: CONTACT lat: 30.47549 lon: -90.10042 facility: Cardiology and Vascular Associates status: RECRUITING city: Bloomfield Hills state: Michigan zip: 48304 country: United States name: Kirit Patel role: CONTACT lat: 42.58364 lon: -83.24549 facility: St. Louis Heart and Vascular Cardiology status: RECRUITING city: Saint Louis state: Missouri zip: 63136 country: United States name: Harvey Serota role: CONTACT lat: 38.62727 lon: -90.19789 facility: Southwest Family Medicine status: RECRUITING city: Dallas state: Texas zip: 75235 country: United States name: Chriistte Dharma role: CONTACT lat: 32.78306 lon: -96.80667 hasResults: False
<|newrecord|> nctId: NCT06369285 id: PUMA-ALI-1201 id: 2024-511497-79-00 type: CTIS briefTitle: A Study of Alisertib in Combination With Endocrine Therapy in Patients With HR-positive, HER2-negative Recurrent or Metastatic Breast Cancer acronym: ALISCA-Breast1 overallStatus: NOT_YET_RECRUITING date: 2024-12-31 date: 2027-06-30 date: 2028-12-31 date: 2024-04-16 date: 2024-04-16 name: Puma Biotechnology, Inc. class: INDUSTRY briefSummary: PUMA-ALI-1201 is a randomized, dose optimization, multicenter, Phase 2 study of alisertib administered in combination with endocrine therapy in participants with pathology-confirmed HR-positive/HER2-negative metastatic breast cancer (MBC) following progression on or after at least two prior lines of endocrine therapy in the recurrent or metastatic setting. This study is intended to evaluate the optimal alisertib dose administered in combination with the selected endocrine therapy. The study is also planned to evaluate the efficacy, safety, and pharmacokinetics of alisertib in combination with endocrine and to identify the biomarker-defined subgroup(s) that may benefit most from combined alisertib and endocrine therapy. conditions: Hormone Receptor Positive HER-2 Negative Breast Cancer conditions: Metastatic Breast Cancer conditions: Recurrent Breast Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 150 type: ESTIMATED name: Alisertib name: Endocrine therapy measure: Objective Response Rate (ORR) Within Dose Subgroup measure: Duration of Response (DOR) Within Dose Subgroup measure: Disease Control Rate (DCR) Within Dose Subgroup measure: Progression Free Survival (PFS) Within Dose Subgroup measure: Overall Survival (OS) Within Dose Subgroup measure: Percentage of Participants With Treatment-Emergent Adverse Events (Adverse Events and Serious Adverse Events) in the Enrolled Population measure: Objective Response Rate (ORR) Within Biomarker-Defined Subgroup measure: Duration of Response (DOR) Within Biomarker-Defined Subgroup measure: Disease Control Rate (DCR) Within Biomarker-Defined Subgroup measure: Progression Free Survival (PFS) Within Biomarker-Defined Subgroup measure: Overall Survival (OS) Within Biomarker-Defined Subgroup sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mayo Clinic city: Rochester state: Minnesota zip: 55905 country: United States lat: 44.02163 lon: -92.4699 hasResults: False
<|newrecord|> nctId: NCT06369272 id: mRNA-1273-P919 briefTitle: Study to Assess Maternal and Infant Outcomes Following Exposure to SPIKEVAX During Pregnancy overallStatus: COMPLETED date: 2023-03-01 date: 2023-10-20 date: 2023-10-20 date: 2024-04-16 date: 2024-04-16 name: ModernaTX, Inc. class: INDUSTRY briefSummary: The primary objectives of this study are:
In infants of women exposed to SPIKEVAX during pregnancy, to assess:
* If exposure to SPIKEVAX during pregnancy is associated with an increased birth prevalence of major congenital malformations (MCMs).
* If exposure to SPIKEVAX during pregnancy is associated with an increased birth prevalence of adverse neonatal and infant outcomes, specifically neonatal encephalopathy, small for gestational age, respiratory distress in the newborn, and incidence of hospitalization due to infections including coronavirus disease 2019 (COVID-19).
* In women exposed to SPIKEVAX during pregnancy, to assess whether exposure to SPIKEVAX is associated with an increased prevalence of hypertensive disorders \[e.g., pre-eclampsia, eclampsia, and gestational hypertension\] gestational diabetes, and post-partum hemorrhage; and
* To assess whether exposure to SPIKEVAX during pregnancy is associated with an increased incidence of stillbirth, preterm birth, and medically attended spontaneous abortion. conditions: Maternal Outcomes conditions: Infant Outcomes conditions: Pregnancy studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 1192 type: ACTUAL measure: Number of MCMs measure: Number of Adverse Neonatal and Infant Outcomes measure: Number of Participants with Hypertensive Disorders measure: Number of Stillbirths, Preterm Births, and Medically Attended Spontaneous Abortions measure: Demographics: Participant Region of Residence measure: Demographics: Age at LMP measure: Demographics: Number of Overweight or Obese Participants measure: Demographics: Duration of Health Plan Enrolment Prior to Pregnancy measure: Demographics: Calendar Date of the Pregnancy Outcome measure: Demographics: Participant Race and Ethnicity measure: Demographics: Participant Socio-economic Status measure: Healthcare Utilization: Number of Office Visits, Emergency Department Visits, and Hospitalizations measure: Healthcare Utilization: Number of Distinct Medications Used sex: FEMALE minimumAge: 13 Years maximumAge: 49 Years stdAges: CHILD stdAges: ADULT facility: Carelon Research city: Newton state: Massachusetts zip: 02458 country: United States lat: 42.33704 lon: -71.20922 hasResults: False
<|newrecord|> nctId: NCT06369259 id: 2023-0997 id: NCI-2024-03302 type: OTHER domain: NCI-CTRP Clinical Registry briefTitle: Open-label Phase 2 Study of Avutometinib (RAF/MEK Clamp) in Combination With Defactinib (FAK Inhibitor) and Cetuximab in Patients With Unresectable, Anti-EGFR-Refractory Advanced Colorectal Cancer overallStatus: NOT_YET_RECRUITING date: 2024-10-31 date: 2026-02-01 date: 2028-02-01 date: 2024-04-16 date: 2024-04-16 name: M.D. Anderson Cancer Center class: OTHER briefSummary: To learn if avutometinib in combination with defactinib and cetuximab can help to control unresectable, anti-EGFR-refractory, advanced colorectal cancer. conditions: Advanced Colorectal Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 33 type: ESTIMATED name: Defactinib name: Cetuximab name: Avutometinib measure: Safety and adverse events (AEs) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: MD Anderson Cancer Center city: Houston state: Texas zip: 77807 country: United States name: Christine Parseghian, MD role: CONTACT name: Christine Parseghian, MD role: PRINCIPAL_INVESTIGATOR lat: 29.76328 lon: -95.36327 hasResults: False
<|newrecord|> nctId: NCT06369246 id: 2023-0893 id: NCI-2024-03308 type: OTHER domain: NCI-CTRP Clinical Registry briefTitle: PRORAD-5 PROstate RADiation in 5 Fractions: Phase Ib Five Fraction Radiotherapy for Patients With Advanced Prostate Cancer overallStatus: NOT_YET_RECRUITING date: 2024-10-31 date: 2025-09-01 date: 2027-09-01 date: 2024-04-16 date: 2024-04-16 name: M.D. Anderson Cancer Center class: OTHER briefSummary: To look at the safety and effectiveness of stereotactic body radiation therapy (SBRT) in treating advanced or high-risk prostate cancer. conditions: Advanced Prostate Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 70 type: ESTIMATED name: Stereotactic Body Radiation Therapy measure: Safety and adverse events (AEs) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: MD Anderson Cancer Center city: Houston state: Texas zip: 77030 country: United States name: Comron Hassanzadeh, MD role: CONTACT phone: 713-657-9802 email: cjhassanzadeh@mdanderson.org name: Comron Hassanzadeh, MD role: PRINCIPAL_INVESTIGATOR lat: 29.76328 lon: -95.36327 hasResults: False
<|newrecord|> nctId: NCT06369233 id: LNC-MS-002 briefTitle: Clinical Study to Evaluate the Anti-adhesion Efficacy and Safety of MegaShield®-SP in Comparison With Guardix-SP Plus After Spine Surgery overallStatus: RECRUITING date: 2024-04-01 date: 2025-02-28 date: 2025-02-28 date: 2024-04-16 date: 2024-04-25 name: L&C Bio class: INDUSTRY name: PROMeDis briefSummary: This study is Interventional, Parallel, Double-blinded, Randomized study. Subjects aged 20 to 70 years who had a Lumbar discectomy or laminectomy, MegaShield-SP® and Guardix-SP Plus will be applied. conditions: Herniation, Disc studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: MegaShield®-SP name: Guardix-SP Plus measure: MRI scar score measure: Oswestry Disability Index(ODI) score measure: Visual Analog Scale(VAS) Back & Leg Pain Score sex: ALL minimumAge: 20 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Eunpyeong ST. Mary's Hospital status: RECRUITING city: Seoul zip: 03312 country: Korea, Republic of name: HyungYul Park role: CONTACT phone: 02-2030-4536 email: matrixbest@naver.com name: HyungYul Kim, Professor role: PRINCIPAL_INVESTIGATOR lat: 37.566 lon: 126.9784 facility: Severance Hospital status: RECRUITING city: Seoul zip: 03722 country: Korea, Republic of name: Siyoung Park role: CONTACT phone: 2228-2194 email: drspine90@yuhs.ac name: Siyoung Park, Professor role: PRINCIPAL_INVESTIGATOR lat: 37.566 lon: 126.9784 facility: Gangnam Severance Hospital status: RECRUITING city: Seoul zip: 06273 country: Korea, Republic of name: Jiwon Kwon role: CONTACT phone: 2019-3411 email: KWONJJANNG@yuhs.ac name: Jiwon Kwon, Professor role: PRINCIPAL_INVESTIGATOR lat: 37.566 lon: 126.9784 facility: Bundang Seoul National University Hospital status: RECRUITING city: Seoul zip: 13620 country: Korea, Republic of name: Hojung Kim role: CONTACT phone: 031-787-7202 email: oshjkim@gmail.com name: Hojung Kim, Professor role: PRINCIPAL_INVESTIGATOR lat: 37.566 lon: 126.9784 hasResults: False
<|newrecord|> nctId: NCT06369220 id: LIA-STI-542 briefTitle: A Study of the Cobas® Liat CT/NG/MG Test Versus Current Standard Practice for Managing Participants at Increased Risk of Sexually Transmitted Infections overallStatus: NOT_YET_RECRUITING date: 2024-06-15 date: 2024-10-31 date: 2024-10-31 date: 2024-04-16 date: 2024-04-16 name: Hoffmann-La Roche class: INDUSTRY name: Roche Molecular Systems, Inc briefSummary: This study is designed to assess the comparative clinical utility of the point of care cobas® liat CT/NG/MG to current standard practices in the diagnosis and treatment of urogenital infections with Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), and Mycoplasma genitalium (MG). conditions: Chlamydia Trachomatis Infection conditions: Neisseria Gonorrhoeae Infection conditions: Mycoplasma Genitalium Infection studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: NONE count: 348 type: ESTIMATED name: cobas® liat CT/NG/MG nucleic acid test name: Standard of Care (SOC): Clinician's Standard Practice measure: Percentage of Participants Given Inappropriate Treatments for All Pathogens Combined (CT, NG, and MG) measure: Percentage of Participants Given Inappropriate Treatment for CT Infection measure: Percentage of Participants Given Inappropriate Treatment for NG Infection measure: Percentage of Participants Given Inappropriate Treatment for MG Infection measure: Mean Satisfaction and Confidence Rating Scores of SOC and POC, According to Healthcare Professionals' Responses to the CSDT Questionnaire measure: Mean Satisfaction Rating Scores of SOC and POC, According to Participants' Responses to the PSDT Questionnaire sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<|newrecord|> nctId: NCT06369207 id: 113454 briefTitle: Investigation of the Transmission Pathways of Reflux in Patients With Chronic Venous Evaluation of Reflux Transmission Pathways in Chronic Venous Insufficiency Patients Secondary to Saphenofemoral Reflux overallStatus: ACTIVE_NOT_RECRUITING date: 2023-09-12 date: 2024-02-15 date: 2024-09 date: 2024-04-16 date: 2024-04-22 name: Golestan University of Medical sciences class: OTHER briefSummary: Chronic venous insufficiency (CVI) is one of the most common medical problems in adults that occurs secondary to the reflux of blood through incompetent valves of lower extremity veins. The most common involved valve is the valve located at the saphenofemoral junction. Although the pathway of reflux transmission is not the same in all patients, the removal or ablation of the greater saphenous vein (GSV) is considered a standard treatment in these patients. However, in patients whose reflux is transmitted to branches other than GSV, this treatment leads to the unnecessary destruction of a competent segment of GSV in addition to remaining at least some segments of incompetent veins. So, in this study, the investigators intend to investigate the different pathways of reflux transmission in chronic venous insufficiency patients who are candidates for GSV ablation/stripping because of saphenofemoral junction insufficiency. This cross-sectional study will be conducted with a descriptive-analytical approach. . conditions: Venous Insufficiency studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 50 type: ACTUAL measure: Determination of reflux transmission pathways in CVI patients with SFJ incompetency measure: Anatomic variations of GSV in CVI patients with SFJ incompetency measure: Prevalence of reflux along GSV main trunk in CVI patients with SFJ incompetency measure: Prevalence of reflux along accessory saphenous veins in CVI patients with SFJ incompetency sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Pezhman Kharazm, MD city: Gorgan state: Golestan zip: 4917956808 country: Iran, Islamic Republic of lat: 36.8427 lon: 54.44391 hasResults: False
<|newrecord|> nctId: NCT06369194 id: POWER5 briefTitle: POWER AUDIT, Postoperative Outcomes Within an Enhanced Recovery After Surgery Protocol overallStatus: ACTIVE_NOT_RECRUITING date: 2023-11-14 date: 2024-04-15 date: 2024-04-15 date: 2024-04-16 date: 2024-04-19 name: Grupo Español de Rehabilitación Multimodal class: OTHER briefSummary: The main objective of this study is to analyze the impact on five years survival of an enhanced recovery program (PRI) after radical surgery for colorectal cancer. As secondaries objectives, we propose to analyze comparing survival distributions between patient groups (ERAS/no ERAS) and the relationship between the ERAS program and early incorporation into oncology therapies (RIOT).
It is proposed to review the medical records of oncology patients included in POWER 1 (as already foreseen in that study), with the aim of performing a 5-year follow-up.
To create comparable treatment and control groups, the Propensity Index method will be used. To study each variable, multivariate regression will be used. Kaplan-Meier will be used for survival and the log-rank test for comparisons. Significance will be considered if p \<0.05 (two tails). conditions: Colorectal Surgery conditions: Critical Pathways conditions: Enhanced Recovery After Surgery conditions: Retrospective Studies conditions: Chemotherapy, Adjuvant studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: RETROSPECTIVE count: 847 type: ACTUAL name: Colorectal Surgery measure: Overall Survival measure: Disease-free survival measure: Time to disease recurrence measure: Time to return to intended oncologic treatment (RIOT) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital Virgen de los Lirios de Alcoy city: Alcoy state: Alicante country: Spain lat: 38.70545 lon: -0.47432 facility: Hospital General Universitario de Elche city: Elche state: Alicante country: Spain lat: 38.26218 lon: -0.70107 facility: Hospital Universitario Central de Asturias city: Oviedo state: Asturias country: Spain lat: 43.36029 lon: -5.84476 facility: Hospital de Igualada city: Igualada state: Barcelona country: Spain lat: 41.58098 lon: 1.6172 facility: Hospital de Sant Joan Despí Moisès Broggi city: Sant Joan d'Espi state: Barcelona country: Spain lat: 41.36718 lon: 2.0574 facility: Fundación Hospital del Espíritu Santo city: Santa Coloma De Gramenet state: Barcelona country: Spain lat: 41.45152 lon: 2.2081 facility: Hospital Universitari Mútua Terrassa city: Terrassa state: Barcelona country: Spain lat: 41.56667 lon: 2.01667 facility: Hospital Universitario de Vic city: Vic state: Barcelona country: Spain lat: 41.93012 lon: 2.25486 facility: Hospital General Universitario de Castellón city: Castellon de la Plana state: Castellón country: Spain lat: 39.98567 lon: -0.04935 facility: Hospital Universitario Puerta de Hierro city: Majadahonda state: Madrid country: Spain lat: 40.47353 lon: -3.87182 facility: Hospital Universitario de Móstoles city: Mostoles state: Madrid country: Spain lat: 40.32234 lon: -3.86496 facility: Hospital Universitario Rafael Méndez city: Lorca state: Murcia country: Spain lat: 37.67119 lon: -1.7017 facility: Hospital Costa del Sol city: Marbella state: Málaga country: Spain lat: 36.51543 lon: -4.88583 facility: Hospital Nuestra Señora del Prado city: Talavera de la Reina state: Toledo country: Spain lat: 39.96348 lon: -4.83076 facility: Hospital Universitario Araba city: Alava country: Spain lat: 43.36057 lon: -6.19946 facility: Hospital General Universitario de Alicante city: Alicante country: Spain lat: 38.34517 lon: -0.48149 facility: Hospital Clínic Universitat de Barcelona city: Barcelona country: Spain lat: 41.38879 lon: 2.15899 facility: Hospital del Mar city: Barcelona country: Spain lat: 41.38879 lon: 2.15899 facility: Hospital Universitario Santa Creu i Sant Pau city: Barcelona country: Spain lat: 41.38879 lon: 2.15899 facility: Hospital Universitario Vall d´Hebrón city: Barcelona country: Spain lat: 41.38879 lon: 2.15899 facility: Hospital General Universitario de Ciudad Real city: Ciudad Real country: Spain lat: 38.98626 lon: -3.92907 facility: Hospital de Galdakao-Usansolo city: Galdakao country: Spain lat: 43.23333 lon: -2.83333 facility: Hospital Universitario Insular de Gran Canaria city: Las Palmas de Gran Canaria country: Spain lat: 28.09973 lon: -15.41343 facility: Hospital Universitario de Gran Canaria Doctor Negrín city: Las Palmas country: Spain lat: 28.58232 lon: -16.16555 facility: Hospital de La Princesa city: Madrid country: Spain lat: 40.4165 lon: -3.70256 facility: Hospital Universitario 12 de Octubre city: Madrid country: Spain lat: 40.4165 lon: -3.70256 facility: Hospital Universitario Infanta Leonor city: Madrid country: Spain lat: 40.4165 lon: -3.70256 facility: Hospital Universitario Ramón y Cajal city: Madrid country: Spain lat: 40.4165 lon: -3.70256 facility: Hospital Universitario San Carlos city: Madrid country: Spain lat: 40.4165 lon: -3.70256 facility: Complejo Hospitalario de Salamanca city: Salamanca country: Spain lat: 40.96882 lon: -5.66388 facility: Hospital Universitario Donostia city: San Sebastián country: Spain lat: 43.31283 lon: -1.97499 facility: Hospital Universitario Virgen Macarena city: Sevilla country: Spain lat: 37.38283 lon: -5.97317 facility: Consorcio Hospital General Unidersitario de Valencia city: Valencia country: Spain lat: 39.46975 lon: -0.37739 facility: Hospital Clínico Universitario de Valencia city: Valencia country: Spain lat: 39.46975 lon: -0.37739 facility: Hospital Clínico de Valladolid city: Valladolid country: Spain lat: 41.65518 lon: -4.72372 facility: Hospital Universitario Miguel Server city: Zaragoza country: Spain lat: 41.65606 lon: -0.87734 hasResults: False
<|newrecord|> nctId: NCT06369181 id: NET 2020 briefTitle: Neuroendocrine Transformation in RB1/TP53 Inactivated NSCLC overallStatus: RECRUITING date: 2021-01-01 date: 2027-12-31 date: 2028-12-31 date: 2024-04-16 date: 2024-04-23 name: Fudan University class: OTHER briefSummary: Histology transformation from non-small cell lung cancer (NSCLC) to neuroendocrine carcinomas (NEC), especially from epidermal growth factor receptor (EGFR) mutant lung adenocarcinoma (LADC) to small cell lung cancer (SCLC), is widely recognized as a rare mechanism for NSCLC to confer tyrosine kinase inhibitors (TKIs) resistance. The probability of its occurrence is about 3-14% in NSCLC patients who are resistant to TKI treatment. In addition to EGFR mutations, NSCLC patients carrying ALK/ROS1 mutations and receiving corresponding TKI treatment may also experience NEC transformation(NET).