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NCT ID: NCT06400017 Not yet recruiting - Clinical trials for Parkinson's Disease and Parkinsonism

Mechanism and Application of DBS in the Treatment of PD

Start date: May 30, 2024
Phase: N/A
Study type: Interventional

Project name: The mechanism and application of deep brain stimulation in the treatment of Parkinson's disease Objective: To test the hypothesis that electrical stimulation of substantia nigra regulates cognitive dysfunction in Parkinson's disease and to reveal its electrophysiological mechanism. Study design: This study is a self-controlled prospective cohort study. By comparing the behavioral characteristics of the memory paradigm under microelectrode stimulation during DBS operation and the characteristics of the underlying electrophysiological signals, and the behavioral characteristics of the memory paradigm and the characteristics of brain network activity under electrical stimulation when DBS is turned on 1 month after surgery. The regulatory effect of substantia nigra DBS on memory network was analyzed. Cases: 60 Case selection: Inclusion criteria: 1)Voluntarily participate in the clinical study and sign the informed consent; 2) Age 50-70 years old, gender unlimited; 3) The clinical diagnosis is consistent with typical PD, and the medical history is less than 20 years; 4) Patients who intend to use 3.0T magnetic resonance compatible dual-channel DBS device (G106R or G106RS, Beijing Pinchi Company) for bilateral subthalamic nucleus DBS surgery to control PD symptoms; 5) MRI excluded patients with obvious structural changes; 6) The visual acuity and hearing of the subjects were basically normal, and the compliance was good, and they could complete the tasks listed in the experimental scheme in accordance with the standards. Exclusion criteria: 1)Serious mental, cognitive and psychological disorders, unable to sign informed consent or cooperate with the operation and various tasks; 2) There are contraindications for neurosurgery, such as hydrocephalus, cerebral atrophy, cerebrovascular sequelae, heart disease and other cardiovascular and cerebrovascular diseases; 3) There are concomitant diseases that seriously affect health, such as tumors, serious abnormalities of liver and kidney function (indexes more than 3 times normal); 4) There is intracranial space occupation, cerebrovascular disease, mental illness, other neurological diseases, claustrophobia, or there is an implant in the body, which affects the nuclear magnetic scan; 5) The results of the Mini-Mental State Scale (MMSE) <24 or the Montreal Cognitive Assessment Scale (MoCA) <18 in the preoperative assessment, or the results of other scales indicate the presence of severe dementia. therapeutic schedule: This study did not change the patient's overall treatment regimen, and only electrical stimulation was tested during and 1 month after DBS surgery Efficacy evaluation: Effectiveness evaluation index (primary efficacy index and secondary efficacy index) : accuracy of memory paradigm, response speed Safety evaluation indicators: blood pressure, heart rate, dual frequency index, patient complaints and symptoms Statistical methods: The group t test was used to compare the normal distribution between the measurement data groups. For measurement data with non-normal distribution, Wilcoxon rank sum test was used for comparison between groups. The study period is January 1, 2024 - December 31, 2026.

NCT ID: NCT06399640 Not yet recruiting - Clinical trials for Acute Myeloid Leukemia

Eltanexor and Venetoclax in Relapsed or Refractory Myelodysplastic Syndrome and Acute Myeloid Leukemia

Start date: July 31, 2024
Phase: Phase 1
Study type: Interventional

This phase I trial tests the safety, side effects, and best dose of eltanexor in combination with venetoclax for the treatment of patients with myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML) that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). Eltanexor works by trapping "tumor suppressing proteins" within the cell, thus causing the cancer cells to die or stop growing. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Giving eltanexor together with venetoclax may be safe, tolerable and/or effective in treating patients with relapsed or refractory MDS or AML.

NCT ID: NCT06399172 Not yet recruiting - Clinical trials for Locally Advanced Pancreatic Adenocarcinoma

OncoSil Pancreatic Cancer Post-marketing Clinical Registry - Italy

OSPRItaly
Start date: May 30, 2024
Phase:
Study type: Observational [Patient Registry]

The OSPRItaly Patient Registry has been developed to assess the performance and safety of the OncoSilā„¢ device when used within the approved indication of unresectable, locally advanced pancreatic cancer, in combination with gemcitabine-based chemotherapy, within a real-world observational registry.

NCT ID: NCT06398938 Not yet recruiting - Clinical trials for Locally Advanced Cervical Carcinoma

Evaluation of Ultraaccelerated High Dose Rate Intrauterine Interventional Radiotherapy

EROS3
Start date: May 6, 2024
Phase:
Study type: Observational

To evaluate the degree of acute and long-term intestinal, urinary and vaginal toxicity, and the impact on sexual activity of an accelerated fractionation of high dose rate interventional radiotherapy (IRT-HDR) in patients with locally advanced cervical cancer (IB2 - VA, N+/-).

NCT ID: NCT06398587 Not yet recruiting - Clinical trials for Stage IV Pancreatic Cancer AJCC v8

Onvansertib in Combination With Gemcitabine and Nab-paclitaxel for the Treatment of Patients With Locally-advanced, Unresectable, or Metastatic Pancreatic Ductal Adenocarcinoma

Start date: June 1, 2024
Phase: Phase 2
Study type: Interventional

This phase II trial studies how well onvansertib in combination with gemcitabine and nab-paclitaxel works in treating patients with pancreatic ductal carcinoma (PDAC) that has spread to nearby tissue or lymph nodes (locally advanced), that cannot be removed by surgery (unresectable), or that has spread from where it first started (primary site) to other places in the body (metastatic). Onvansertib is a small chemical molecule that binds and stops the function of of PLK1 in tumor cells. By attacking the PLK1 protein, onvansertib is thought to reduce tumor cells ability to replicate and grow; causing them to die. Chemotherapy drugs, such as gemcitabine and nab-paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy with onvansertib may kill more tumor cells in patients with locally-advanced, unresectable, or metastatic pancreatic ductal carcinoma.

NCT ID: NCT06398080 Not yet recruiting - Visual Impairment Clinical Trials

An Observational Study to Investigate the Use of Aflibercept 8 mg to Treat Adult Patients With Neovascular Age-Related Macular Degeneration (nAMD) and Diabetic Macular Edema (DME) in a Real-World Setting

SPECTRUM-US
Start date: August 12, 2024
Phase:
Study type: Observational

The purpose of this research study is to observe the patient's clinical care and how EYLEA® HD is used as a treatment in real-world settings. Patients are asked to join the study because they have either neovascular age-related macular degeneration (nAMD/wet age-related macular degeneration [AMD]) or diabetic macular edema (DME). Patients cannot have used EYLEA® HD in the past and the doctor must be planning to treat nAMD or DME with a new prescription of EYLEA® HD (aflibercept 8 mg).

NCT ID: NCT06397417 Not yet recruiting - Clinical trials for Out-of-Hospital Cardiac Arrest

Refractory Cardiac Arrest Treated On Field By ECMO

ReCATOBE
Start date: May 2024
Phase:
Study type: Observational

Out-of-hospital cardiac arrest without resumption of spontaneous circulatory activity despite advanced medical resuscitation is considered refractory. Under certain well-defined conditions, today in many cities around the world and particularly in Paris, it benefits from resuscitation called ECPR (extracorporeal cardiopulmonary resuscitation). This technique consists of the installation of an extracorporeal membrane oxygenation (ECMO) device allowing organ perfusion while waiting for a resumption of cardiac activity. Since 2011, the Paris SAMU (SAMU 75) has set up a team capable of implementing ECPR for refractory out-of-hospital cardiac arrests. This team based within the SAMU of Paris at the Necker hospital (ECMO team) composed of an emergency doctor or anesthesiologist-resuscitator, a nurse anesthetist and an ambulance driver intervenes in Paris and its nearby region at the request of medical regulation. Given the growing development of this activity, it is essential to measure its effectiveness in real-life conditions.

NCT ID: NCT06396767 Not yet recruiting - Cardiac Surgery Clinical Trials

Diaphragmatic Inspiratory Amplitude as a Prognosticator for Postoperative Pulmonary Complications After Cardiac Surgery

Start date: June 1, 2024
Phase:
Study type: Observational

Cardiac surgery is a critical intervention for a variety of cardiovascular conditions, yet it can frequently results in a spectrum of postoperative complications. Amongst various morbidities, Post-Operative Pulmonary Complications (POPCs) represent a significant clinical challenge leading to adverse outcomes like increased morbidity, mortality, and raised healthcare expenditures. The diaphragm, as the principal respiratory muscle, plays a pivotal role in maintaining pulmonary function. Diaphragmatic dysfunction (DD) in the perioperative period of Cardiac surgery has an incidence of up to 20%. Understanding the impact of DD on postoperative pulmonary function is imperative for optimizing patient care and clinical outcomes. Its occurrence has been linked to a spectrum of respiratory complications, ranging from pneumonia to difficulty in weaning from mechanical ventilation. In recent years, the advent of point-of-care ultrasonogram (POCUS) has emerged as a promising modality for real-time monitoring of DD. It offers a more accessible and feasible approach compared to traditional methods, providing immediate feedback on diaphragmatic movement, and facilitates timely intervention. Ultrasound has been used to assess Diaphragmatic Inspiratory Amplitude (DIA) (the expansion of the diaphragm when breathing). DIA has been shown to decrease in the post-operative period after cardiac surgery, which has been well-correlated with the occurrence of POPCs, however, its predictive value has not yet been studied in a cohort of cardiac surgical patients. Hence, we aim to address this gap by exploring the utility of DIA measured by ultrasonogram as a predictive tool in anticipating the occurrence of POPCs. We hypothesize that DIA can predict the occurrence of POPC in cardiac surgical patients. We will recruit 130 patients at University Hospital, London Health Science Centre, to this prospective, observational study.

NCT ID: NCT06396533 Not yet recruiting - Clinical trials for Urothelial Carcinoma

Increasing Pre-Surgical Identification of Muscle Invasive Tumor Evaluations Prior to Planned Cystectomy (INSITE)

INSITE
Start date: May 2024
Phase:
Study type: Observational

This trial aims at investigating the diagnostic ability of a combined diagnostic panel including systematic endoscopic evaluation (SEE), blood-based ctDNA assay, and urine-based cfDNA assay to predict the presence of residual tumor remaining in the bladder at cystectomy. Patients who are planned for cystectomy due to bladder cancer will be considered for enrollment based on inclusion and exclusion criteria.

NCT ID: NCT06396338 Not yet recruiting - Clinical trials for Voluntary Termination of Pregnancy

Voluntary Surgical Terminations of Pregnancy: Comparison of the Hemorrhagic Risk Depending on the Term

HEMOVG
Start date: September 2024
Phase:
Study type: Observational

Voluntary termination of pregnancy (abortion) is a major current societal issue. This is a very common situation, around 225,000 abortions are carried out every year in France. The legislation has recently been amended, with the law of March 2, 2022 aimed at strengthening the right to abortion (no. 2022-295) which extended the legal period for voluntary termination of pregnancy from 14 to 16 weeks amenorrhea (AS). The National College of French Obstetrician Gynecologists (CNGOF), in a press release published on October 12, 2020 in response to the proposed law adopted by the National Assembly, wishes to draw attention to the fact that the procedure of surgical abortion between 14 and 16 SA changes nature. He states that additional procedures are necessary beyond 14 weeks, which could be a source of complications. In addition, the practice recommendations have not been updated following this extension of time, the centers performing abortions are therefore free regarding the protocol for carrying out these so-called late abortions (between 14 and 16 weeks). There are two pregnancy termination techniques practiced in France: medical or surgical. Due to the recent nature of these late abortions, practitioners still have little experience of the consequences of these procedures and this compromises the quality of the information provided to patients. It is necessary to have quality studies to improve knowledge about late-term abortions, in order to be able to correctly inform patients and allow them to make an informed choice regarding the method used. This study follows the modification of the legislation extending the legal period for abortion, with the aim of providing arguments regarding the safety of carrying out surgical abortions at these more advanced stages of pregnancy. In addition, abortion often generates anxiety, the term at which it is carried out could influence the experience of patients. This study would therefore also improve knowledge about the experience of abortion, in order to better support patients throughout their journey.