cyrilzakka/clinical-trials huggingface dataset:
SHR-1701 in Subjects With Metastatic or Locally Advanced Solid Tumors

The main purpose of this study is to assess the safety and tolerability of SHR-1701 at different dose levels. Study consists of dose-escalation part and an expansion part in subjects with metastatic or locally advanced solid tumors.

This is a Phase I, open-label, multiple-ascending dose trial. Study consists of dose-escalation part in subjects with metastatic or locally advanced solid tumors, and expansion part with selected indications.

Eligibility Criteria:
Inclusion Criteria:

* Able and willing to provide signed informed consent form, and able to comply with all procedures.
* Histologically or cytologically proven metastatic or locally advanced solid tumors.
* Male or female subjects aged 18-75 years.
* Life expectancy \>= 12 weeks as judged by the Investigator.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at trial entry.
* Disease must be measurable with at least 1 uni dimensional measurable lesion by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
* Adequate hematological, hepatic and renal function as defined in the protocol

Other protocol-defined inclusion criteria could apply.

Exclusion Criteria:

* Prior therapy with an anti-PD1, anti-PD-L1, anti-CTLA-4 or a TGFb inhibitor.
* Anticancer treatment within 28 days before the first dose of study drug.
* Major surgery within 28 days before start of trial treatment.
* Systemic therapy with immunosuppressive agents within 7 days prior to the first dose of study drug; or use any investigational drug within 28 days before the start of trial treatment.
* With any active autoimmune disease or history of autoimmune disease.
* With active central nervous system (CNS) metastases causing clinical symptoms or requiring therapeutic intervention.
* Clinically significant cardiovascular and cerebrovascular diseases
* History of immunodeficiency including seropositive for human immunodeficiency virus (HIV), or other acquired or congenital immunedeficient disease, or any active systemic viral infection requiring therapy.
* Previous malignant disease (other than the target malignancy to be investigated in the trial) within the last 2 years. Subjects with history of cervical carcinoma in situ, superficial or non-invasive bladder cancer or basal cell or squamous cell cancer in situ previously treated with curative intent are NOT excluded.
* Receipt of any organ transplantation, including allogeneic stem-cell transplantation

Other protocol-defined exclusion criteria could apply
Vitamine D in Multiple Sclerosis

Two hundred and forty patients with multiple sclerosis who met the study criteria will be enrolled in this randomized double blind placebo-controlled clinical trial.

They will randomly assigned to placebo or vitamin D treatment group. The total time of study is 52 weeks and the vitamin D group will be treated by weekly 50000 International unit(IU) vitamin D, while the other group will receive weekly placebo. The annual relapse rate and EDSS will be compared at baseline, month 6 and 12.


Eligibility Criteria:
Inclusion Criteria:

* BMI:18-30kg/m2
* caucasian race
* Relapsing remitting multiple sclerosis
* treatment with interferon beta

Exclusion Criteria:

* Recent vitamin D supplement therapy
* Restricted fat diet
* nephrolithiasis in recent 5 years
* Past history of hyperparathyroidism, sarcoidosis, cancer
* Past history of hepatic disease
* Past history of gastrointestinal disease
* Past history of mycobacterial infection
* Past history of hypercalcemia and hypercalciuria
* serum creatinine\>1.5
* Smoking, drug abuse and corticosteroid therapy in recent year
* treatment with thiazides or other drugs that inhibit vitamin D absorption
* Disease attack in recent 2 months
* Serum Ca\>2.6mm0l/L
* Serum 25(OH)D\>85mmol/L
* hypersensitivity to cholecalciferol
* Past history of heart disease
* Major depression
* Uncontrolled hypertension (BP\>180/110)
* Immunosuppressive therapy
Modified Reporting of Positive Urine Cultures Collected From Long Term Care

Asymptomatic bacteriuria (AB) is a condition in which bacteria are detected in urine culture without urinary symptoms. The inappropriate use of antibiotic treatment for AB selects bacterial flora to express resistance mutations. Reducing inappropriate antibiotic use for AB is difficult, since the microbiology laboratory cannot distinguish patients with AB. The investigators study will use a restricted laboratory report requesting the physician to call the laboratory for culture results. The restricted report may reduce the rate of inappropriate treatment of AB.

Positive urine cultures during the study period will be randomized to restricted microbiology laboratory reporting or standard microbiology laboratory reporting. Physician or patient consent will not be collected. Patient records will be assessed by the investigator to determine if patients have AB or urinary tract infection. Physician antibiotic treatment decision in both groups will be collected.

Eligibility Criteria:
Inclusion Criteria:

1. Consecutive positive urine cultures collected from patients admitted to Long term care facilities will be included. All methods of urine collection will be included (midstream, in-and-out catheterization, indwelling catheter).

Exclusion Criteria:

1. Positive urine cultures not collected from Long term care facility patients
2. Pregnancy
3. Antibiotic treatment at the time of collection
4. Patients known to have blood neutrophils \<1.0 within 7 days of urine collection
Blood Test to Predict Radiation Response and Toxicity in Patients Undergoing Radiation Therapy

Collect blood samples and associated clinical data prior to and post radiation treatment.

Exploratory study to collect paired pre- and post-irradiation blood samples from 150 participants.

Eligibility Criteria:
Inclusion Criteria:

1. Male and female patients age 18 or older
2. Diagnosed with a primary rectal or esophageal cancer
3. Planned radiation therapy to the esophagogastric area to a minimum of 4140 cGy for esophageal/gastroesophageal junction cancer or to pelvis to a minimum of 4500 cGy for rectal cancer as part of clinical care
4. Combining chemotherapy is allowed
5. ECOG Performance Status 0-2
6. Able to provide written informed consent

Exclusion Criteria:

1. Subjects who have received radiation within three (3) months to esophagogastric or pelvic areas prior to consent
2. Subjects, who in the opinion of the investigator, may not be able to comply with the requirements of the study
Methyl-donor Nutrient Supplementation and Methylation Profile in Lupus Patients With Obesity

Dietary supplementation with methyl donors has been demonstrated to increase DNA methylation in leucocytes whereas a limited dietary intake of methyl donors was associated with DNA hypomethylation. Considering SLE disease, previously study showed that high doses of vitamin B6 and folate were associated with less severe SLE. Furthermore, some evidences reported a relatively high incidence of decreased serum B12 levels in rheumatic patients. This led to the suggestion that diets rich in methyl group donors could have beneficial effects on SLE.


Eligibility Criteria:
Inclusion criteria:

* SLE diagnosis
* Female
* In pre-menopausal period
* Aged between 18 to 45 years
* Patients that meet the classification criteria according to Systemic Lupus International Collaborating Clinics classification criteria (SLICC)
* Patients with SLEDAI score ≤ 4 on Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K)
* Under prednisone treatment at a dosage \<10 mg/day
* Under treatment with chloroquine at a stable dose
* BMI \> 18,5 kg/m2

Exclusion Criteria:

* Current infection
* Diabetes
* Arterial hypertension
* Smokers
* Pregnancy
* Anticoagulants use
* Methotrexate use
* Other autoimmune diseases
* Current vitamin B12 or/and folic acid supplementation
Affect Regulation Based on Brain-computer Interface Towards Treatment for Depression

The primary objective is to examine the feasibility and efficacy of a locally developed brain-computer interface (BCI) based system training for regulating mood in healthy elderly. The investigators hypothesize that elderly who complete the training program will be better at regulating emotions as compared to controls, based on their ratings of the primary outcome measures.

In this project, we will leverage on a locally developed electroencephalograph (EEG)-based BCI technology for decoding affective states of the brain, and thereby develop a closed-loop sensing and stimulation mechanism. The technology uses advanced neural signal computing on the EEG in real-time and audio feedback using a machine learning model that associates individual user's EEG characteristics in relation to music-emotion features. The system is portable and will allow emotion regulation training to be done outside of hospital setting with ease thus potentially addressing the treatment gap for MDD in the elderly.

This is a two group randomized study. One group will undergo the intervention which is 24 sessions of BCI emotion regulation training (i.e. listening to music with audio feedback to regulate emotions towards positive affect) over an 8-week period. The control group will undergo 8 weeks of music sessions, without any emotion regulation training. Both groups will undergo pre- and post- psychometric assessments looking at cognition, quality of life, functioning and emotional states. This study will also carry out functional MRI of the brain before and after 8 weeks of either training (intervention) or music music session (control) to examine changes associated with the affective BCI training. Study findings derived from psychometric assessments, EEG analysis and neuroimaging will provide evidences on efficacy and usability of this technology.

Eligibility Criteria:
Inclusion Criteria:

* English-speaking
* Geriatric Depression Scale score of 4 and below
* Fit to provide informed consent
* Able to travel to study site independently

Exclusion Criteria:

* Presence of hearing impairment
* Presence of any known neuropsychiatric disorders (e.g. dementia, epilepsy or mental retardation)
* Contraindications for MRI such as surgical clips, cardiac pacemakers, metal implants and plates, orthodontics and claustrophobia
Memantine for the Treatment of Cognitive Impairment in Systemic Lupus Erythematosus

A phenome-wide association study (PheWAS) identified an association between a variant in the human gene for the N2A subunit of the N-methyl-D-aspartate (NMDA) receptor, GRIN2A, and Systemic Lupus Erythematosus (SLE). A single nucleotide polymorphism (SNP) in this gene encodes for increased NMDA receptor activity. Based on the potential function of the associated SNP and published literature, alterations in SNP function signaling may underlie a cluster of symptoms. The objective of this study is to evaluate the safety, tolerability and efficacy of memantine, an NMDA receptor antagonist, in a precise patient subset with SLE. Participants will complete a full 14-week clinical trial, receiving either memantine or a placebo. Participants' blood will be drawn to test for various antibodies as well as organ function. Patients' urine will also be collected to assess organ function and pregnancy for females at a number of specific time points. The overall goal is to develop a safe and inexpensive therapeutic approach to reduce debilitating cognitive symptoms in a precisely selected SLE sub-population.


Eligibility Criteria:
Inclusion Criteria:

1. Meet American College of Rheumatology (ACR) criteria for SLE
2. Report NPSLE symptoms on the screening survey recommended by EULAR guideline but limited to the psychiatric manifestations questions
3. Score ≤ 85 on the RBANS total index (≤ 1 SD below the normative mean of 100)

Exclusion Criteria:

1. Male and female subjects \<18 or \>60 years
2. Change in medication that may affect mood or cognition including prednisone, antidepressant medications, or stimulants within the last 4 weeks
3. Regular (daily) use of opioids or other drugs of abuse including heavy alcohol or marijuana use
4. Metabolic derangement defined as liver function tests \>3x upper limit of normal or severe renal disease defined as calculated creatinine clearance \<30 mL
5. Severe psychiatric disease including schizophrenia, psychosis, suicidal depression
6. Other factors which in the opinion of the investigator could potentially impact the study outcomes (e.g., underlying disease, medications, history)\* or prevent the participant from completing the protocol (poor compliance or unpredictable schedule)
7. Inability or refusal to give informed consent for any reason including a diagnosis of dementia or significant cognitive impairment\*\*
8. Patients who are pregnant
9. Patients who are enrolled in other investigational drug studies
Utilizing Novel Blood RNA Biomarkers as a Diagnostic Tool in the Identification of Long COVID-19

The Primary objective of this study is to determine, using unblinded samples, if it is possible to develop an algorithm for the classification of specific blood RNA from patients with long COVID together and separately from the apparent health normal controls and other medical conditions that share the signs and symptoms of long COVID.

Participants will be screened and provide two blood samples28 (+/- 2) days apart. Based on the participants survey results they will be placed into one of fourteen groups that reflect the type of Long COVID the patient is experiencing. Samples will be shipped to the sponsor who will develop an AI process to validate the type of Long COVID and assess its severity. The long term goal is to develop a reliable test to identify the presence of Long COVID and its severity.

Eligibility Criteria:
Inclusion Criteria:

* Mentally capable of understanding and completing informed consent for the study.
* Precipitants with a lab verified diagnosis of SARS-CoV-2 or clinician note/record that an appropriate rapid test for SARS-CoV-2 was positive.
* To qualify for long COVID group participants will need to have new, persistent symptoms related to SARS-CoV-2 infection. iv. No one under the age of 18.

Exclusion Criteria:

* Subject is unable to provide informed consent.
* Primary Investigator or Sub-Investigator determines the participant's ongoing medical complaints that began after 1 November 2019 are not related to SARS-COV-2 but another disease process.
Docetaxel in Node Positive Adjuvant Breast Cancer

The purpose of this study was to compare disease-free survival after treatment with docetaxel in combination with doxorubicin and cyclophosphamide to 5-fluorouracil in combination with doxorubicin and cyclophosphamide in operable breast cancer patients with positive axillary lymph nodes.

In addition to the 5-year analysis conducted in September 2003, two other analyses were planned when 590 and 700 Disease Free Survival events occurred. However, due to the lower than predicted DFS event rate, and in agreement with FDA and EMA, a time-based final analysis at 10 years was considered more appropriate than an event-based (700 Disease Free Survival events) analysis.

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven breast cancer (invasive adenocarcinoma with at least one axillary lymph node showing evidence of tumor among a minimum of six resected lymph nodes).
* Definitive surgical treatment must be either mastectomy, or breast conserving surgery with axillary lymph node dissection for operable breast cancer. Margins of resected specimen from definitive surgery must be histologically free of invasive adenocarcinoma and ductal carcinoma.

Exclusion criteria:

* Prior systemic anticancer therapy for breast cancer (immunotherapy, hormonotherapy, chemotherapy).
* Prior anthracycline therapy or taxoids (paclitaxel, docetaxel) for any malignancy.
Evaluation of Transforaminal Epidural Steroid Injection in Radicular Low Back Pain According to MSU Classification

Low back pain is a common disease in all ages and it effects seriously quality of life. Medical treatment,interventional methods and surgery are the treatment options. Transforaminal epidural steroid injections (TFSI) is one of the interventional method for radiculopathy with low back pain. Michigan State University(MSU) classification is a MRI based disc herniation classification. It helps to classified disc herniation in types, places and sizes.

The aim of this study to evaluate the pain and oswestry disability index in patients who have radiculopathy with low back pain, undergone TFSI according to MSU classification.


Eligibility Criteria:
Inclusion Criteria:

* between the ages of 18-65
* After outpatient evaluation, a decision was made to perform transforaminal steroid injection,
* Low back pain of more than 6 on a numeric rating scale (NRS)
* Radiculopathy for more than 4 weeks and less than one year and straight leg raising \<45
* Disc herniation at the L4-L5 or L5-S1 level on MRI
* Failure to respond to medical treatment for at least one month

Exclusion Criteria:

* Neurological deficit,
* Bleeding problems,
* Localized infection,
* Spinal pathologies (such as tumors),
* Fractures,
* Severe stenosis,
* Uncontrolled diabetes,
* Pregnancy,
* Red flag symptoms (such as motor and/or sphincter dysfunction)
* Patient reluctance,
* Computed tomography (CT) and MRI findings in favor of sequestrated fragments from herniated disc,
* Sphincteric disorders,
* Previous spine surgeries
Predictors and Clinical Outcomes of Patients With Coronary Heart Disease Co-morbid Depression Post Percutaneous Coronary Intervention

A prospective, multicenter, registered cohort study to observe the incidence of 1-year major adverse cardiac events in patients with coronary heart disease co-morbid depression treated with percutaneous coronary intervention and to clarify the predictors of 1-year major adverse cardiac events post PCI among these patients.

Coronary heart disease (CHD) is a clinical relevant psychosomatic issue. Treatment strategies include percutaneous coronary intervention (PCI), guidelines medication (GDMT) and coronary artery bypass grafting (CABG) were clinical proven to be effective to realize myocardial revascularization post CHD. Previous studies revealed that diagnosed depressed CHD patients have 3.6 times higher risk of major adverse events (MACE) post percutaneous coronary intervention than nondepressed. However, a reliable explanation of how depression impact clinical outcomes of CHD patients post PCI is lacking. The objective of this study is to observe the incidence of major adverse cardiovascular events in patients with coronary heart disease co-morbid with depression post PCI, and to explore a prognostic model of clinical outcomes based on physiological, interventional, socio-economic and psychological factors among these patients.

Eligibility Criteria:
Inclusion Criteria:

1. Provision of informed consent prior to any study specific procedures;
2. Men and women 18 years or older；
3. Diagnosed CHD needed to and can be treated with PCI according to the guidelines of ACC/AHA；
4. Willingness to participate in the follow-up study for at least 1 year.

Exclusion Criteria:

1. Inability to provide written informed consent;
2. Diagnosed mental illness or medical history (including schizophrenia, bipolar disorder, severe dementia or Lifetime alcohol or substance abuse);
3. Tendency of suicide;
4. Pregnant or lactating women;
5. Any physical or intellectual inability or disability that may affect completion of self-assessment tools, study protocol and follow-up requirements;
6. Any other reasons that investigators based on professional judgments that would place the patient at increased risk.
7. Patient with STEMI within 24-hour from the onset of chest pain to admission.
Evaluation of Diagnostic Criteria for Creutzfeldt Jakob Disease

Clinicians know little about Creutzfeldt Jakob disease, and they are not proficient in the diagnostic criteria of Creutzfeldt Jakob disease, so it is easy to misdiagnose or delay the diagnosis. As a rare central nervous system disease, it is necessary, feasible and practical to evaluate the diagnostic criteria of Creutzfeldt Jakob disease.

To master the clinical application of the diagnosis of Creutzfeldt Jakob disease (WS / T 562-2017) and the problems in the implementation process; The rationality, practicability and operability of the diagnostic criteria were evaluated scientifically; Reduce the misdiagnosis rate; To provide clinical basis and suggestions for further improving the diagnostic criteria. Through consulting the literature of Creutzfeldt Jakob disease, the clinical manifestations, laboratory examination, auxiliary examination and pathological results of Creutzfeldt Jakob disease were analyzed and compared with the current diagnostic criteria; The clinical diagnosis and misdiagnosis of Creutzfeldt Jakob disease were analyzed; To train medical staff at all levels to apply the diagnostic criteria of Creutzfeldt Jakob disease, and to discuss the clinical cases of Creutzfeldt Jakob disease in many hospitals.

Eligibility Criteria:
Inclusion Criteria:

* Patients with Creutzfeldt Jakob disease

Exclusion Criteria:

* none
Hemodynamic Change of Coronary Atherosclerotic Plaque After Evolocumab Treatment

Compelling evidences indicate that lipid-lowering therapy can reduce the high-risk plaque feathers and improve the coronary flow reserve. This study is going to investigate the change of lesion-specific hemodynamic significance as determined by ML(Machine Learning)-based CT-FFR (Computed Tomography-Fractional Flow Reserve)after Evolocumab treatment.


Eligibility Criteria:
Inclusion Criteria:

* 1.baseline CCTA revealed at least one lesion with stenotic extent from 50% to 69% on major epicardial arteries (diameter ≧2 mm);
* 2.patients were referred for optimal medical treatment;
* 3.patients agreed to undergo follow-up CCTA at 1-year interval.

Exclusion Criteria:

* 1.patients had previous history of myocardial infarction or coronary revascularization;
* 2.patients were contraindicated to the usage of iodine contrast media;
* 3.image quality of baseline or follow-up CCTA was severely impaired (in presence of severe artifact, non-diagnostic);
* 4.patients withdrew the informed consents during follow-up;
* 5.patients experienced major adverse cardiac events during follow-up;
* 6.patients refused to undergo follow-up CCTA;
* 7.lost follow-up