Symptoms and General Pathology

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Nervous System Diseases

Heart and Blood Diseases

Hemorrhage

Ganglion Cysts

Synovial Cyst

Basal Ganglia Hemorrhage

Cysts

Mucinoses

Connective Tissue Diseases

Cerebrovascular Disorders

Basal Ganglia Diseases

Brain Diseases

Central Nervous System Diseases

Cerebral Hemorrhage

Intracranial Hemorrhages

Vascular Diseases

Coagulants

All Drugs and Chemicals

Fibrinolytic Agents

Hemostatics

Tissue Plasminogen Activator

Stereotactic puncture aspiration to evacuate basal ganglion hematoma with use of thrombolytic agent

Minimally invasive puncture aspiration plus rt-PA

Drugs for symptomatic treatment such as hemostasis and nerve nourishing.

Conservative medical treatment

Spontaneous cerebral hemorrhage is one of the main causes of death and disability all over the world, accounting for 20%-30% of all cerebrovascular diseases. Minimally invasive surgery of cerebral hemorrhage, especially puncture aspiration, can improve early and long-term neurological recovery in patients with cerebral hemorrhage. Until now, no standardized practice for minimally invasive surgery of spontaneous cerebral hemorrhage has been established. Hematoma puncture and drainage based on CT scans without precise localization and personalized approach design, which may lead to poor efficacy and high risk of complications. The investigators' hospital has much experience in treating cerebral hemorrhage with stereotactic puncture and aspiration. So the investigators conduct a prospective multicenter randomized controlled clinical trial across the country to determine the therapeutic effects of puncture aspiration plus thrombolysis treatment for the perioperative and long-term recovery of patients with small hematoma in deep basal ganglia via computerized precision coordinates and personalized approach design.

1. Prospective enrollment of patients with small spontaneous basal ganglia hematoma according to the inclusion and exclusion criteria in 14 major neurosurgical centers across the country to establish a multi-center clinical database of spontaneous small basal ganglia hematoma with data maintenance and update.
2. Random allocation of the patients enrolled into control group (conservative treatment with conventional drugs) or intervention group (minimally invasive puncture aspiration plus rt-PA); long-term follow-up for 6 months to compare the recent and long-term mortality rate, disability rate and related complications of the two groups.

Stereotactic Operation Integrating With Thrombolysis in Basal Ganglion Hemorrhage Evacuation II

Stereotactic Operation Integrating With Thrombolysis in Basal Ganglion Hemorrhage Evacuation II (SOITBE II)

ADL: Activities of Daily Living, ranges from 0-100, a higher ADL score means a better situation.

GCS: Glasgow Coma Scale, ranges from 3-15, a higher GCS score means a better situation.

Huashan Hospital

First Affiliated Hospital of Guangxi Medical University

Southern Medical University, China

China-Japan Friendship Hospital

The First Affiliated Hospital of Anhui Medical University

Second Affiliated Hospital of Xi'an Jiaotong University

The Affiliated Hospital Of Southwest Medical University

Tibet Autonomous Region People's Hospital

The Second Affiliated Hospital of Harbin Medical University

First Affiliated Hospital of Xinjiang Medical University

The Affiliated Hospital of Inner Mongolia Medical University

General Hospital of Ningxia Medical University

Central South University

Second Affiliated Hospital, School of Medicine, Zhejiang University

Hematoma

stereotactic puncture and aspiration to evacuate basal ganglion hematoma with or without thrombolytic agent

stereotactic surgery plus thrombolysis

gao chen

Spontaneous cerebral hemorrhage is one of the main causes of death and disability all over the world, accounting for 20%-30% of all cerebrovascular diseases. Minimally invasive surgery of cerebral hemorrhage, especially puncture aspiration, can improve early and long-term neurological recovery in patients with cerebral hemorrhage. Until now, no standardized practice for minimally invasive surgery of spontaneous cerebral hemorrhage has been established. Hematoma puncture and drainage based on CT scans without precise localization and personalized approach design, which may lead to poor efficacy and high risk of complications. Our hospital has much experience in treating cerebral hemorrhage with stereotactic puncture and aspiration. So we conduct a prospective multicenter randomized controlled clinical trial to determine the therapeutic effects of puncture aspiration plus thrombolysis treatment for the perioperative and long-term recovery of patients with small to moderate hematoma in deep basal ganglia via computerized precision coordinates and personalized approach design.

Sterotactic Operation Integrating With Thrombolysis in Basal Ganglion Hemorrhage Evacuation

Sterotactic Operation Integrating With Thrombolysis in Basal Ganglion Hemorrhage Evacuation: a Randomized Controlled Trial.

GOS: Glasgow Outcome Scale, ranges from 1-5, a higher GOS score means a better situation.

Sir Run Run Shaw Hospital

Ningbo No. 1 Hospital

Ningbo Medical Center Lihuili Hospital

Second Affiliated Hospital of Wenzhou Medical University

Affiliated Wenling Hospital of Wenzhou Medical University

Affiliated Zhuji Hospital of Wenzhou Medical University

Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University

Jinhua Central Hospital

Huizhou Municipal Central Hospital

People's Hospital of Quzhou

The Sixth Affiliated Hospital of Wenzhou Medical University

The Second Affiliated Hospital of Jiaxing University

Rare Diseases

Acute Graft Versus Host Disease

best dose of hUMSCs (from cohort 1) or placebo

stereotactic surgery

single intracavitary infusion 1 day after stereotactic aspiration surgery

hUMSCs

placebo

Jianmin Zhang, Doctor

A study to examine the safety and potential effectiveness of human umbilical cord mesenchymal stem cells (hUMSCs) in adults who have suffered spontaneous cerebral hemorrhage in basal ganglia. The hypothesis is that hUMSCs will be safe and can improve neurological function after intracerebral hemorrhage so that improve the prognosis of patients.

The hUMSCs suspension and placebo solvent have different appearance so only the participants but not the researches can be masked.

Intracavitary Injection of hUMSCs in Acute Basal Ganglia Hematoma After Stereotactic Aspiration

Intracavitary Injection of Human Umbilical Cord Mesenchymal Stem Cells in Acute Basal Ganglia Hematoma After Stereotactic Aspiration: a Randomized, Single-blind, Placebo-Controlled, Phase 2 Trial

The Modified Rankin Scale (mRS) measures independence rather than performance of specific tasks. Scale consists of six grades from 0 to 5; 0 denotes no symptoms and 5 indicates severe disability. For clinical purpose, mild disability range is from 0 to 2; moderate disability ranges from 3 to 4 and 5 indicates severe disability.

The National Institutes of Health Stroke Scale (NIHSS) is a 15-item impairment scale used to measure stroke severity. The NIHSS includes the following domains: level of consciousness, eye movements, integrity of visual fields, facial movements, arm and leg muscle strength, sensation, coordination, language, speech and neglect. Each impairment is scored on an ordinal scale ranging from 0 to 2, 0 to 3, or 0 to 4. Item scores are summed to a total score ranging from 0 to 42 (the higher the score, the more severe the stroke).

The Barthel index (BI) is an ordinal scale used to measure performance in activities of daily living (ADL). It uses ten variables describing ADL and mobility including: help needed with grooming, toilet use, feeding, transfers, walking, dressing, climbing stairs, bathing, presence of absence of fecal incontinence and urinary incontinence. Each performance item is rated on this scale with a given number of points from 0 to 10 or 0 to 15. Item scores are summed to a total score ranging from 0 to 100. A higher number is associated with a greater likelihood of being able to live at home with a degree of independence. Totally dependent ranges from 0 to 20, severe dependent ranges from 21 to 60, moderate dependent ranges from 61 to 90, mild dependent ranges from 91 to 99, and 100 indicates completely independent.

The Glasgow coma scale (GCS) is based on a 15-point scale for estimating and categorizing the consciousness. The test measures the motor response (1 to 6), verbal response (1 to 5) and eye opening response (1 to 4). The score is determined by the sum of the score in each of the 3 categories, with a maximum score of 15 and a minimum score of 3. A lower number indicating a more severe injury and a poorer prognosis.

The Glasgow outcome score (GOS) applies to patients with brain damage allowing the objective assessment of their recovery. This allows a prediction of the long-term course of rehabilitation to return to work and everyday life. Scale consists of five grades from 1 to 5. 1 denotes death. 2 denotes persistent vegetative state.3 denotes severe disability. 4 denotes moderate disability and 5 denotes low disability.

The First Affiliated Hospital, University of Science and Technology of China

Huzhou Hospital, School of Medicine, Zhejiang University

First Affiliated Hospital of Fujian Medical University

Jinhua Hospital, School of Medicine, Zhejiang University

Taizhou Hospital

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Neoplasm Metastasis

Carcinoma

Brain Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Neoplastic Processes

Central Nervous System Neoplasms

Nervous System Neoplasms

Antineoplastic Agents

Osimertinib

Stereotactic surgery (SRS) to the brain metastases and continuation of Osimertinib, at 2 month (8 weeks) post Osimertinib start

At two month (8 weeks) post Osimertinib start, patients will be randomized into one of the two study arms. Arm A patients will be treated with stereotactic surgery (SRS). In both arms Osimertinib treatment will continue.

Stereotactic surgery

Amichay Meirovitz, MD, MBA

Philip Blumenfeld, MD

This study involves patients with EGFR-mutated NSCLC and asymptomatic brain metastases. This is an open-label, randomized study, comparing the continuation of Osimertinib treatment alone to Osimertinib treatment combined with early intervention stereotactic radiosurgery (SRS). The current first line of care for EGFR-mutated NSCLC is administration of Osimertinib, a small molecule that penetrates the blood brain barrier (BBB) well and controls majority, but not all, of the brain metastases. We hypothesize that relatively early intervention with SRS to brain metastases that are still visualized by MRI 2 months-post initiation of Osimertinib treatment, LUNG- will improve long term brain control, cognitive abilities and potentially overall survival. Patients with EGFR-mutated NSCLC and asymptomatic brain metastases will be treated with Osimertinib for 2 months. Brain MRI scans will be collected pre-Osimertinib and 2 months after treatment start. Patients with asymptomatic brain metastases present after 2 months of Osimertinib will be randomized into one of two study arms. Arm A patients will be treated with SRS while continuing Osimertinib, while arm B patients will continue with Osimertinib alone. Patients will be assessed based on brain and whole body progression by RECIST. Patients will also be assessed for CNS-PFS and body-PFS, cognitive function, Quality of life and overall survival status via routine follow-up tests.

A Study to Evaluate the Efficacy of Osimertinib With Early Intervention SRS Treatment Compared to the Continuation of Osimertinib Alone, in Patients With EGFR Mutated NSCLC and Asymptomatic Brain Metastases

A Multi-center, Open-label, Randomized, Two-arm Study, to Evaluate the Efficacy of Osimertinib With Early Intervention SRS Treatment Compared to the Continuation of Osimertinib Alone, in Patients With EGFR Mutated NSCLC and Asymptomatic Brain Metastases.

Data for individual participants will be collected anonymously via the study CRF, data will be analyzed statistically and published.

Lesions that did not disappear after two months of Osimertinib treatment will be better controlled with SRS

Whole body progression will be delayed when Osimertinib is combined with early treatment of SRS

Patient cognitive function will improve after SRS treatment

Patient QOL will improve after SRS treatment

Time until whole brain radiation will be given will prolong for patients who receive early SRS treatment

Patient OS will improve after SRS treatment

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Stereotactic Operation Integrating With Thrombolysis in Basal Ganglion Hemorrhage Evacuation II	NCT04172376	Basal Ganglia H...	Minimally invas... Conservative me...	18 Years - 70 Years	Second Affiliated Hospital, School of Medicine, Zhejiang University
Sterotactic Operation Integrating With Thrombolysis in Basal Ganglion Hemorrhage Evacuation	NCT03957707	Basal Ganglia H...	stereotactic su...	18 Years - 70 Years	Second Affiliated Hospital, School of Medicine, Zhejiang University
Intracavitary Injection of hUMSCs in Acute Basal Ganglia Hematoma After Stereotactic Aspiration	NCT04074408	Basal Ganglia H...	stereotactic su... hUMSCs placebo	30 Years - 75 Years	Second Affiliated Hospital, School of Medicine, Zhejiang University
Intracavitary Injection of hUMSCs in Acute Basal Ganglia Hematoma After Stereotactic Aspiration	NCT04074408	Basal Ganglia H...	stereotactic su... hUMSCs placebo	30 Years - 75 Years	Second Affiliated Hospital, School of Medicine, Zhejiang University
A Study to Evaluate the Efficacy of Osimertinib With Early Intervention SRS Treatment Compared to the Continuation of Osimertinib Alone, in Patients With EGFR Mutated NSCLC and Asymptomatic Brain Metastases	NCT05033691	NSCLC EGFR Gene Mutat... EGF-R Positive ... Non-small Cell ... Brain Metastase...	Stereotactic su...	18 Years - 120 Years	Hadassah Medical Organization

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