cyrilzakka/clinical-trials huggingface dataset:
Mindfulness Engaged Neurostimulation for Depression

Repetitive Transcranial Magnetic stimulation (rTMS) is an FDA-approved therapy for treatment resistant depression (TRD) that involves brief magnetic stimulation pulses on the dorsolateral prefrontal cortex (DLPFC) brain region. But studies of rTMS alone show remission rates of \~30%. Additionally, rTMS has not been shown to improve cognitive functioning that may be an independent factor predicting treatment success. This study will develop a novel multimodal treatment, which combines intermittent theta burst stimulation (iTBS) - a type of rTMS with digital mindfulness training to engage brain plasticity, enhance cognition and alleviate depression symptoms in individuals with TRD.

This study aims to develop a novel multimodal treatment for treatment resistant depression (TRD), which combines intermittent theta burst stimulation (iTBS), a type of FDA-approved rTMS protocol, with digital mindfulness training. We propose that this multimodal treatment will suppress posterior Default Mode Network (pDMN) brain activity as measured with electroencephalography (primary outcome and neural target), as well as enhance cognition and alleviate depression symptoms in patients with TRD. The study will determine the optimal dose required for neural target engagement by the multimodal iTBS + digital mindfulness training relative to an active control training combined with iTBS.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of major depressive episode (MDE, in accordance with the Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-5), in the context of unipolar major depressive disorder.
* At least one failed antidepressant medication trial at level 3 in the Antidepressant Treatment History Form: Short Form (ATHF-SF) classification.
* Montgomery-Åsberg Depression Rating Scale (MADRS) Score \>19 (moderate - severe depression).
* No increase or initiation of new antidepressant therapy in the four weeks prior to screening.
* Demonstrated capacity to give informed consent.

Exclusion Criteria:

* Inability to provide informed consent.
* Medically unstable patients.
* Concomitant neurological disorder or a history of a seizure disorder.
* Exhibiting current suicidal behavior rating on the Columbia Suicide Severity Rating Scale (C-SSRS)
* Patients who are pregnant or breastfeeding.
* Any psychotic disorder or current active psychotic symptoms.
* Patients who have intracranial implants, other medical device or condition deemed unsafe for TMS.
* Contraindication to MRI scanning.
Study of MGCD0103 Given Three Times Weekly in Patients With Relapsed and Refractory Lymphoma

In this study, MGCD0103, a new anticancer drug under investigation, is given three times weekly to patients with relapsed and refractory lymphoma.


Eligibility Criteria:
Inclusion Criteria:

* Pathologic confirmation of relapsed or refractory lymphoma.

  1. DLBCL stage II-IV
  2. Follicular lymphoma
* At least one site of measurable disease (≥ 2.0 cm with conventional techniques; physical exam \[PE\], CT, X-ray, MRI).
* Prior treatment:

  1. DLBCL cohort: Disease progression following initial therapy and transplant (unless the patient is ineligible or refused transplant). There is no limit to number of prior therapies.
  2. Follicular lymphoma cohort: Follicular lymphoma that is relapsed following or refractory to standard therapy and/or existing therapies or are not eligible for or are unlikely to achieve clinical benefit from those therapies. Patients must have failed 3 or more prior therapies.
* Must have at least one of the following considered related to disease:

  1. Local symptoms due to progressive or bulky nodal disease.
  2. Compromise of normal organ function due to progressive or bulky disease.
  3. Presence of systemic B symptoms.
  4. Presence of symptomatic extranodal disease.
  5. Cytopenias due to extensive bone marrow infiltration, autoimmune hemolytic anemia or thrombocytopenia, or hypersplenism.
* ECOG performance status of 0 or 1.
* Aged 18 years or older.
* Laboratory requirements.

Exclusion Criteria:

* Patients with another active cancer (excluding basal cell carcinoma or cervical intraepithelial neoplasia \[CIN/cervical in situ\] or melanoma in situ). Prior history of cancer is allowed, as long as there is no active disease.
* Pregnant or lactating women.
* Patients with uncontrolled intercurrent illness, active or uncontrolled infections, or a fever \>38.5 Celsius (not due to tumor fever) on the day of scheduled dosing.
* Patients with a history of pericardial disease.
* Patients with small, moderate or large pericardial effusions or patients with a diagnosis of pericarditis.
* Patients with significant cardiac abnormalities.
* Patients with serious illnesses, medical conditions, or other medical history which would be likely to interfere with patient's participation in the study or with the interpretation of the results.
* Patients who have been treated with any investigational drug within 28 days prior to study initiation.
* Known hypersensitivity to HDAC inhibitors and to any components of MGCD0103.
* Known human immunodeficiency virus (HIV) or active Hepatitis B or C.
* Central nervous system lymphoma and lymphoma involving leptomeningeal area.
Vitamin C Supplement for Lumbar Spine Surgery

By doing this study, researchers hope to learn effects of Vit C on lumbar spine surgery outcomes.

Lumbar spine surgeries are common procedures for management of low back pain and their prevalence is increasing. However, their outcomes are less than optimal.

An effective and inexpensive solution to minimizing surgical complications and expediting recovery following lumbar spine surgery could be supplementation using high doses of vitamin C, also known as ascorbic acid. Vit C can help reduce oxidative stress and inflammation and improve immune system and body's own chemicals to fight pain.

The researchers want to examine if Vit C is effective in decreasing pain and pain medications and improving function. Gaining a better understanding of effects of Vit C on patient recovery may lead to improved outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled to have a lumbar spine fusion
* Can read and understand the English language
* BMI 35 or less

Exclusion Criteria:

* Patients taking certain medications
* lumbar spine laminectomy or discectomy
* taking a Vit C supplement
* pregnancy
* Cauda equine syndrome or spinal tumor
* neurological, neurodegenerative or cognitive issues
* renal pathology
* sickle cell anemia
* iron metabolism disorder
Recent-Onset Type 1 Diabetes Trial Evaluating Efficacy and Safety of Teplizumab

The purpose of this study is to determine whether teplizumab slows the loss of β cells and preserves β cell function in children and adolescent 8-17 years old who have been diagnosed with T1D in the previous 6 weeks..

Subjects will receive two courses of either teplizumab or placebo treatment 6 months apart.

This is a Phase 3, randomized, double-blind, placebo-controlled, multinational, multi-center study to evaluate the efficacy and safety of teplizumab, a humanized, anti-CD3 monoclonal antibody, in children and adolescents ages 8 through 17 recently diagnosed with type 1 diabetes (within 6 weeks of diagnosis). Approximately 300 participants will be randomized at a ratio of 2:1 to either the teplizumab group or the placebo group.

Teplizumab or matching placebo will be administered in two courses 6 months apart. Each course of treatment will include daily infusions for 12 days. The total study duration for each participant will be up to 86 weeks.

The primary objective is to determine whether two courses of teplizumab administered 6 months apart slows the loss of β cells and preserves β cell function over 18 months (78 weeks) in children and adolescents 8-17 years old who have been diagnosed with T1D in the previous 6 weeks.

The secondary objectives are to evaluate improvements in key clinical parameters of diabetes management, to determine the safety and tolerability of teplizumab, and to evaluate the pharmacokinetics (PK) and immunogenicity of teplizumab

Eligibility Criteria:
Inclusion Criteria:

1. Is 8 to 17 years of age, inclusive, at the time of randomization/initiation of study drug administration.
2. Has received a diagnosis of type 1 diabetes (T1D) according to the criteria from the American Diabetes Association.
3. Is able to be randomized and initiate study drug within 6 weeks (42 days) of the formal T1D diagnosis.
4. Has a peak stimulated C-peptide of ≥0.2 pmol/mL from a mixed meal tolerance test (MMTT) at screening.
5. Has a positive result on testing for T1D-related autoantibodies.

Exclusion Criteria:

1. Has any autoimmune disease other than T1D with the exception of stable thyroid or celiac disease.
2. Has an active infection and/or fever.
3. Has a history of or serologic evidence at screening of current or past infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV).
4. An individual who has a medical, psychological or social condition that, in the opinion of the Principal Investigator, would interfere with safe and proper completion of the trial.
Place-based Mapping in EAS Listeners

Purpose: Investigate monaural and binaural hearing in electric-acoustic stimulation (EAS) users with place-based versus default maps.

Participants: Cochlear implant recipients and normal-hearing listeners Procedures (methods): This is a prospective, longitudinal investigation of the monaural and binaural outcomes (such as speech perception, spatial hearing, and/or subjective benefit) of cochlear implant recipients listening with different programs. The programs will incorporate different patient and device variables to determine the effect on cochlear implant recipient outcomes.


Eligibility Criteria:
Cochlear implant participants

Inclusion Criteria:

* 18-80 years of age at implantation, identify English as native language, Medical Electronics (MED-EL) array recipient, and a postoperative unaided detection threshold of less than or equal to 65 decibel (dB) hearing level (HL) at 125 Hz

Exclusion Criteria:

* Report or present with a cognitive delay or impairment

Normal-hearing controls

Inclusion Criteria:

* 18-80 years of age at time of testing, unaided detection thresholds of 35 dB HL or better from 500-4000 Hz, identify English as native language

Exclusion Criteria:

* Report or present with a cognitive delay or impairment
Clinical Study of ABCD in the Treatment of Cryptococcal Meningitis

To evaluate the efficacy and safety of ABCD in the treatment of cryptococcal meningitis in non-HIV patients at week 4, the end of induction therapy, week 10 and the end of consolidation therapy.

This study is a multi-center, single-arm clinical study. The objective is to evaluate the efficacy and safety of ABCD in the treatment of cryptococcal meningitis in non-HIV patients. Qualified subjects shall receive cryptococcus induction therapy with ABCD combined with flucytosine for at least 4 weeks, or termination of treatment early at the investigator's discretion. Efficacy and safety are followed up at week 4 (day 28), the end of induction therapy, week 10 (day 70) and the end of consolidation therapy.

Eligibility Criteria:
Inclusion Criteria:

* ≥18 years old and ≤70 years old, no gender limitation;
* Diagnosis of cryptococcal meningitis (with or without other cryptococcal lesions) based on CSF culture and/or CSF ink staining smear and/or CSF antigen testing;
* The researcher believes that patients can benefit from participating in this study;
* The subjects voluntarily participated in the study and signed the informed consent.

Exclusion Criteria:

* Patients with other invasive fungal diseases;
* HIV infected patients;
* Patients who received intravenous polyene treatment within the past 6 months;
* Allergic to Amphotericin B Colloidal Dispersion or other ingredients in this product;
* Patients with abnormal liver function \[aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>＝5 times the upper limit of normal value (ULN) without total bilirubin elevation, or ALT or AST \>＝ 3 times ULN with total bilirubin \>＝ 1.5 times\];
* Patients with impaired renal function (renal function index blood creatinine (Cr) is more than 2 times higher than ULN, or 24-hour urine creatinine clearance rate （Ccr） is less than 50ml/min), or patients requiring/undergoing hemodialysis or peritoneal dialysis;
* Pregnant women, breast-feeding women and women of childbearing age who were unable to take effective contraceptive measures during the study period;
* Conditions considered unsuitable for the study by the investigator, such as concomitancy of severe organ insufficiency, clinically significant laboratory abnormalities, comprehension or compliance problems, etc.
Canadian WATCHMAN Registry

Canadian WATCHMAN Registry is a multicentre (8 Centres) Canadian prospective, non-randomized, registry to enrol 100 consecutive patients undergoing LAA closure with the WATCHAN device to study the safety and effectiveness of the WATCHMAN device

Atrial fibrillation (AF) is the most common cardiac arrhythmia with current prevalence estimated at 1.5-2% of the general population. AF is a major cause of stroke, responsible for 15% of all strokes and 30% of strokes in patients age \>80. Stroke is the leading cause of long-term disability and is the 4th leading cause of death in the US. Anticoagulation is the mainstay therapy for preventing strokes in AF with a 64% relative stroke reduction and 26% relative mortality benefit with warfarin therapy. Warfarin or newer anticoagulation treatments (NOAC) have been associated with increased risk of major bleeding and therefore a significant proportion (30-50%) of eligible patients do not receive therapy due to perceived risk of bleeding. The need for newer therapy is therefore required and percutaneous left atrial appendage closure (LAAC) devices have been investigated for patients with high risk of stroke and contra-indication to long term oral anticoagulation therapy. The WATCHMAN device is one of the leading LAA closure devices and with the most world-wide clinical experience. The investigators are running a multicentre (8 Centres) Canadian prospective, non-randomized, registry to enrol 100 consecutive patients undergoing LAA closure with the WATCHAN device to study the safety and effectiveness of the WATCHMAN device.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years, and
* CHADS2 ≥1 and/or CHADS-VASc ≥2, and
* Prior major bleeding (intracranial, gastrointestinal bleeding, intraocular, respiratory, genitourinary, retroperitoneal, pericardial, anemia requiring transfusions, etc.), or contraindications to long-term OAC (HASBLED ≥3, high fall risk, cerebral aneurysm, blood dyscrasias, aortic dissection, etc.), or failure of OAC (stroke/TIA while on OAC)

Exclusion Criteria:

* Presence of LAA thrombus
* Severe untreated mitral stenosis (no prior valve replacement)
The Effect of Carvedilol Vs Propranolol in Cirrhotic Patients With Variceal Bleeding

To compare the efficacy and safety of Carvedilol and Propranolol in patients with cirrhosis-related esophagogastric varices after multiple endoscopic treatments for secondary prophylaxis.

The study is a randomized controlled trial. Patients randomly enter into two treatment groups: 1)the Carvedilol group and 2)the Propranolol group. Treatment allocation is by block randomization, with an equal number for Carvedilol and Propranolol. The results are concealed in opaque envelopes. The dose of non-selective β-blocker(NSBB) is titrated according to systolic arterial blood pressure (ABPsys) and heart rate (HR). Doses are increased every 2-3 days until ABPsys is not less than 90 mm Hg and HR is not less than 55 bpm. Carvedilol is started at a dose of 6.25mg/d, and titrated to a maximum dose of 25mg/d. Patients receiving propranolol start at a dose of 30 mg/day and the dose will be increased to a maximum dose of 160 mg/day. Patients will be followed up with telephone calls every 2 months. After taking these 2 drugs for 6 months, patients come for clinic visits, receiving laboratory tests and endoscopic examinations, and events of primary and secondary outcomes will be analyzed.

Eligibility Criteria:
Inclusion Criteria:

* age between 18-70 years old;
* cirrhotic patients referred to Zhongshan Hospital with esophagogastric varices confirmed by endoscopy;
* history of variceal bleeding; at least 3 times of endoscopic treatment;
* with 1) mild esophageal varices;2) gastric varices with a diameter less than 5mm; or 3) variceal eradication at the time of recruiting.

Exclusion Criteria:

Patients are excluded when they have

* episodes of variceal bleeding after the last endoscopic treatment;
* diagnosis of hepatic cellular carcinoma;
* severe systemic diseases;
* refractory ascites;
* contraindication to Carvedilol or Propranolol, such as: asthma, chronic obstructive pulmonary disease, allergic rhinitis, New York Heart Association IV chronic heart failure, atrioventricular blockade, severe bradycardia(HR\<50bpm), sick sinus syndrome, cardiogenic shock, severe hypotension(ABPsys\<85mmHg);
* previous and continued use of β-blockers;
* Child -Pugh Class C.
Safety and Immunogenicity of a Commercially Available Influenza Vaccine (Formulation 2006/2007) When Administered to Subjects 18 Years of Age or Older

To evaluate the antibody response to each influenza vaccine antigen when administering a single dose to subjects aged 18 years and over


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older

Exclusion Criteria:

* any serious disease such as cancer, autoimmune disease, advanced arteriosclerotic disease or complicated diabetes mellitus, chronic obstructive pulmonary disease (COPD) that requires oxygen therapy, acute or progressive hepatic disease, acute or progressive renal disease, congestive heart failure and bleeding diathesis or conditions associated with prolonged bleeding time
* hypersensitivity to eggs, chicken protein, chicken feathers, influenza viral protein, neomycin or polymyxin or any other component of the vaccine known or suspected (or high risk of developing) impairment/alteration of
* immune function within the past 7 days any acute disease or infections requiring systemic antibiotic or antiviral therapy (chronic antibiotic therapy for urinary tract prophylaxis was acceptable)
* fever within the past 3 days
* history of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine
* within the past 12 months have received more than one injection of influenza vaccine
* Women who are pregnant or women able to bear children but not willing to practice acceptable contraception for the duration of the trial (21 days)
A Clinical Study of Iobitridol in Patients Undergoing Multislice Computed Tomography (CT) Abdominal Angiography

This is a clinical study of iobitridol in patients undergoing multislice CT (MSCT) abdominal angiography.


Eligibility Criteria:
Inclusion Criteria:

* Male or female having reached legal majority age and up to 85 years included.
* Scheduled for an aorta and abdominal arterial tree evaluation by MSCT, either for pre-therapeutic evaluation or for post-surgical control or follow-up (including patients with prosthetic vascular material).
* Female of childbearing potential must have effective contraception (contraceptive pill or intra-uterine device), or be surgically sterilised, or post-menopausal (minimum 12 months amenorrhea) or must have a documented negative urine and/or blood pregnancy test at screening.

Exclusion Criteria:

* Patients with overt non-compensated heart failure.
* Patients with hemodynamic instability.
* Patients with ESC (European Society of Cardiology)/ESH (European Society of Hypertension) grade 3 hypertension (SBP \[systolic blood pressure) over or equal to 180 mm Hg or DBP \[diastolic blood pressure\] over or equal to 110 mm Hg)
* Patients with known severe renal failure (defined as creatinine clearance \< 30 ml/min as calculated by the Cockroft and Gault formula).
* Patients who have received diuretic or biguanide treatment during the 48 hours preceding the MSCT scan.
* Patients with known thyreotoxicosis.
* Patients with history of immediate or delayed major hypersensitivity reaction to iodinated contrast media.
Anti-Xa Levels in Critically Ill Patients Receiving Low-molecular-weight Heparin for Thromboprophylaxis in China

Critically ill Patients are at high risk to develop deep venous thrombosis. However, despite receiving of a standard dose of Low-molecular-weight Heparin（LMWH）, many patients still develop life-threatening embolism. The purpose of this study is to evaluate the anti-Xa levels of different dosing regimens of LMWH in critically ill patients in China.


Eligibility Criteria:
Inclusion Criteria:

* Adult Critically ill patients

Exclusion Criteria:

* Contraindication to use of LMWH. Intracranial bleeding/stroke, hematoma or bleeding disorder. Use Heparin anticoagulant therapy
Circumferential Section Pane Less Than 1 mm in Esophagectomy for Esophageal Cancer.

A suspicious circumferential resection margin (CRM), defined as tumor cells within 1 mm of the CRM, is still controversial. The aim of this study was to compare the clinical significance of a suspicious CRM to histologically positive (R1) and negative margin (R0) resections in patients with pT3 esophageal and GE-Junction tumors.

From our prospectively build database 923 consecutive pT3 patients operated between january 1990 and june 2013 were selected. CRM status in patients treated by surgery only (n = 747) or after neoadjuvant therapy (n = 176) was recorded prospectively after surgery.

Kaplan-Meier survival curves were generated, and factors affecting survival were assessed by Cox regression multivariate analysis.

Eligibility Criteria:
Inclusion Criteria:

* pathologic T3 tumours of esophagus or GEJ

Exclusion Criteria:

* pT other than pT3
* R2 resections