Franklin, Massachusetts

Effect of Transcranial Alternating Current Stimulation(tACS) for Early Alzheimer's Disease

Upon meeting the inclusion criteria and providing informed consent, each participant will complete a series of cognitive assessments and tACS at the First Affiliated Hospital of Anhui medical university. Patients were randomly allocated to tACS group and the sham group. There are about 20 patients in each group. For the all patients, allocation was by coin toss. Patients were studied using a double-blind design. Study participants and all personnel responsible for the clinical care of the patient remained masked to allocated condition and allocation parameters. Only tACS administrators had access to the randomization list; they had minimal contact with the patients, and no role in cognitive and symptom assessments. Each patient would be treated for continuous 14 days by tACS. Before the tACS treatment, a series of cognitive assessments and neuropsychological tests were obtained by a trained investigator to assess baseline. Each assessment will involve a set of assessment tools, the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) as the primary outcome measure and various other tasks and questionnaires to measure cognition (including MoCA,MMSE, DS, Stroop test, TMT, BNT-30, VFT, CDT,JLOT. Form H,HVOT), memory (CAVLT, LMT), emotion(HAMA-17,HAMD-14,GDS-30), behavioral and psychological symptoms(NPI), and treatment tolerability. All the tests are conducted in two days. The patient received resting EEG data collection. After the last treatment, the MoCA, and associative memory were obtained, as well as the Global Index of Safety to assess adverse events of the treatment. Patients were instructed to focus their answers on the past 14 days. The patients had also receiving a battery measure of neuropsychological tests, resting EEG. Two months after the last treatment, participants were interviewed to obtain the same assessment as before. They were instructed to focus their answers on the past months.

Hypofractionated Radiotherapy Combined with Immunotherapy for Limited-stage Small-cell Lung Cancer

Trial design: To enroll 45 patients diagnosed with limited stage small-cell lung cancer to receive concurrent chemoradiotherapy with consolidative Adebrelimab maintenance. Primary endpoint: Progression-free Survival Secondary endpoint: 2-year progression-free survival, 2-year overall survival rate. All enrolled patients are proposed to receive concurrent chemoradiotherapy and consolidative Adebrelimab maintenance up to 2 years. After concurrent chemoradiotherapy, hippocampus-sparing prophylactic cranial irradiation or MRI surveillance are both allowed. Chemotherapy: Etoposide 80-100mg/m2 day 1, 2, 3 and cisplatin 75-80mg/m2 day 1 & carboplatin AUC 5 day 1 q3w for totally 6 cycles. Radiotherapy began at the second cycle of chemotherapy followed by hippocampus-sparing prophylactic cranial irradiation or MRI surveillance. Immunotherapy consolidation began at the third cycle of chemotherapy: Adebrelimab 1200mg q3w to 2 year or disease progression & untolerated toxicity. Radiotherapy details: Radiotherapy CT simulation: 4-Dimensional CT (4D-CT) with intravenous contrast is recommended for simulation. Scan thickness should be less than 5 mm. Thermal mask or vacuum bag is recommended. Target Delineation: Considering hypofraction and involved field irradiation (IFI), only Internal Tumor Volume (ITV) should be delineated without the need to delineate Clinical Tumor Volume (CTV). Delineation of ITV: ITV should include pulmonary gross tumor and metastatic mediastinal lymph nodes. PET-CT registration with simulation CT is recommended for patients with obstructive atelectasis. For patients with suspected mediastinal lymph nodes, Endobronchial Ultrasound-guided Transbronchial Needle Aspiration (EBUS-TBNA) is recommended. Production of Planning Tumor Volume (PTV): PTV is produced by a margin of 5 mm added to ITV. Modification of PTV is suggested to respect anatomic boundary. Dosimetric Limitation: 95% prescription dose should cover 100% PTV and 95% PTV should receive 100% prescription dose. Total Lung: V20<23%, Dmean<13Gy, V5<50%. Spinal Cord: Dmax<40Gy. Heart: V30<40%, Dmean<25Gy. Esophagus: V40<5cc. Treatment Implementation: Radiotherapy is implemented every day. Cone-beam CT should be utilized every day to minimize set-up error. Follow-up: Patients should be follow-up every three months right after the completion of the final cycle of immunotherapy to 3 years after that. Then follow-up every half year is allowed to 5 years. After 5 years, follow-up every year is appropriate. In follow-up, chest CT and abdominal ultrasonography should be implemented. Cranial MRI should be performed every half year. Bone scan should be undertaken every year for all patients. Inclusion Criteria: 1. 18-70 years old; 2. ECOG 0-1; 3. Adequate organ function to tolerate chemotherapy, immunotherapy and radiotherapy; 4. Small-cell lung cancer; 5. Limited stage confirmed by cranial MRI, chest CT, abdominal ultrasonograph, bone scan or cranial MRI and PET-CT; 6. Signature of inform consent. Exclusion Criteria: 1. Younger than 18 years old or older than 70 years old; 2. ECOG>1; 3. Inadequate organ function to tolerate chemotherapy, immunotherapy and radiotherapy; 4. Non-small cell lung cancer and other neuroendocrine carcinoma including typical or atypical carcinoid, large-cell neuroendocrine carcinoma; 5. Extensive stage confirmed by cranial MRI, chest CT, abdominal ultrasonograph, bone scan or cranial MRI and PET-CT; 6. No signature of inform consent.

Effect of Neuronavigated Theta-Burst Transcranial Magnetic Stimulation (TBS) for Early Alzheimer's Disease

All patients underwent a series of medical assessments that included physical examination and routine laboratory studies before and after repetitive transcranial magnetic stimulation (rTMS) treatment. Upon meeting the inclusion criteria and providing informed consent, each participant will complete a series of cognitive assessments and rTMS treatments at the First Affiliated Hospital of AnHui medical university. Patients were randomly allocated to rTMS group 1(real 1) and rTMS group 2 (real 2). In real group 1, the investigators constructed the core damage network of mild cognitive impairment by the method of damage network mapping and targeted to modulate this network in anticipation of improving the cognitive function of the patients. In real group 2, the investigators constructed the executive control network through previous literature reports and targeted to modulate this network in anticipation of improving patients' cognitive functions. There are about 20 patients in each group. For the all patients, allocation was by coin toss. Patients were studied using a double-blind design. Study participants, clinical raters, and all personnel responsible for the clinical care of the patient remained masked to allocated condition and allocation parameters. Only rTMS administrators had access to the randomization list; they had minimal contact with the patients, and no role in cognitive and symptom assessments. Each patient would be treated for continuous 14 days by rTMS. Before the rTMS treatment, a series of cognitive assessments and neuropsychological tests were obtained by a trained investigator to assess baseline. Each assessment will involve a set of assessment tools, the associative memory as the primary outcome measure and various other tasks and questionnaires to measure cognition (including MoCA, MMSE, ADAS-cog, DS, Stroop test, TMT, BNT-30, VFT, CDT, JLOT. Form H,HVOT), memory (CAVLT, LMT), emotion(HAMA-17,HAMD-14,GDS-30), behavioral and psychological symptoms(NPI), and treatment tolerability. All the tests are conducted in two days. The patients underwent a magnetic resonance imaging (MRI) scan with multiple modalities. After the last treatment, the MMSE, MoCA and ADAS-cog were obtained, as well as the Global Index of Safety to assess adverse events of the treatment. Patients were instructed to focus their answers on the past 14 days. The patients had also receiving a battery measure of neuropsychological tests, magnetic resonance imaging scan in multi-modalities. Three months after the last treatment, participants were interviewed to obtain the same assessment as before. They were instructed to focus their answers on the past months.

AZD4205 in Relapsed or Refractory Peripheral T Cell Lymphoma (JACKPOT27)

A Clinical Trial to Evaluate the Safety, Efficacy, and Pharmacokinetics of MegaLT Injection for Treating Refractory Thrombocytopenia Following Radiotherapy, Chemotherapy, or Transplantation.

A single-center, open-label, dose-escalation study to assess the safety, efficacy, and pharmacokinetics of MegaLT for treating refractory thrombocytopenia following radiotherapy, chemotherapy, or transplantation.

Safety and Efficacy of Anti-CD20/CD30 CAR-T Cells in Subjects with Relapsed/Refractory Lymphoma

The study will enroll subjects with CD20 and CD30-positive lymphoma, CD20-positive lymphoma, or CD30-positive Hodgkin lymphoma. Subjects will receive a single infusion of anti-CD20/CD30-CAR-T cells after screening, PBMC collection, and lymphodepleting chemotherapy. Toxicity will be assessed according to the Common Terminology Criteria for Adverse Events (CTCAE, version 5.0) from the National Cancer Institute. Safety of anti-CD20/CD30-CAR-T cell therapy will be evaluated through laboratory tests, including 12-lead electrocardiograms, vital sign checks, etc. Additionally, blood samples will be collected from subjects to study cellular pharmacokinetics and explore the effects of cell therapy on ferritin, C-reactive protein, and related cytokines.

Anti-CD19-CAR-T Cells in Subjects with Relapsed/Refractory B Cell Malignancies

This study will enroll subjects with CD19-positive relapsed/refractory B-cell malignancies. The effectiveness assessments for anti-CD19-CAR-T cell therapy is evaluated according to international criteria including the 2018 Lugano Classification. Toxicity is evaluated based on the Common Terminology Criteria for Adverse Events (CTCAE, version 5.0) from the National Cancer Institute. The safety of anti-CD19-CAR-T cell therapy will be evaluated through laboratory tests, 12-lead EKGs, and vital signs monitoring. Additionally, blood samples from subjects will be collected to study cellular metabolism and explore the effects of cell therapy on ferritin, C-reactive protein, and related cytokines.

An Open-label Study on the Clinical Efficacy of rTMS Intervention in PD

As an innovative non-invasive neuromodulation technology, repetitive transcranial magnetic stimulation (rTMS) has demonstrated efficacy in improving motor symptoms in patients with Parkinson's disease (PD). The supplementary motor area (SMA) has been identified as a brain region significantly associated with motor symptoms in PD patients. However, no large-sample clinical studies have yet established the clinical efficacy of rTMS, guided by neuroimaging navigation, targeting the SMA in patients with Parkinson's disease. We describe a open-lable study designed to recruit 20 patients with idiopathic Parkinson's disease. Participants will be randomly assigned to receive either real stimulation or sham stimulation, with the left SMA undergoing 7 days of continuous theta burst stimulation (cTBS). The primary outcome measure is the change in the Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III scores from baseline to post-treatment and follow-up. Secondary outcomes include changes in scores on other clinical symptom scales.

DZD8586 in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (TAI-SHAN9)