cyrilzakka/clinical-trials huggingface dataset:
Mechanism of Resistance to GNC-038 in Relapsed and Refractory Diffuse Large B-cell Lymphoma

This is an exploratory study embedded in the Phase Ib/II clinical trial of CD3 x 4-1BB x CD19 x PD-L1 tetra-specific T cell engager GNC-038 in relapsed and refractory diffuse large B-cell lymphoma initiated by the corresponding pharmaceutical company. By measuring immune cell components and their functional phenotypes in peripheral blood and tumor tissues before and after the subject's medication, this study aims to identify key immune cell populations and immune molecules which play an important role in resistance to GNC-038 treatment, so as to optimize drug design and develop combination therapies to improve treatment efficacy.


Eligibility Criteria:
Inclusion Criteria:

For Group 1, the selection criteria are firstly concordant with those of the corresponding clinical trial. On this basis, additional selection criteria for this study are:

* Lymph node lesions with long diameter ≥ 2cm.
* Subjects have the ability and willingness to follow the visit, biosample collection and other research-related processes prescribed by the research program and to sign informed consent forms.

For Group 2, the selection criteria are:

* The subject is able to understand the informed consent form, and voluntarily participates and signs the informed consent form;
* Age between 18 and 80;
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 points.

Exclusion Criteria:

For Group 1, the exclusion criteria are totally concordant with those of the corresponding clinical trial. There is no additional exclusion criteria for this study.

For Group 2, the exclusion criteria are:

* History of past or present malignant diseases;
* Patients with active autoimmune diseases, or patients with a history of autoimmune diseases, including but not limited to Crohn's disease, ulcerative colitis, systemic lupus erythematosus, sarcoidosis, Wegener's granulomatosis, polyvascular inflammation granuloma, Grave's disease, rheumatoid arthritis, pituitary inflammation, ophthalmic pigmentitis, autoimmune hepatitis, systemic sclerosis, Hashimoto thyroiditis, autoimmune vasculitis, autoimmune neuropathy (Guillain- Barre syndrome), etc.;
* Human immunodeficiency virus antibody positive, active tuberculosis, active hepatitis B virus infection (HBsAg-positive or HBcAb-positive, HBV-DNA test positive), hepatitis C virus infection (HCV antibody-positive and HCV-RNA test positive), EB virus infection (EBV-DNA test positive), cytomegalovirus infection (CMV-DNA test positive) or herpes simplex virus infection (HSV-DNA test positive);
* Pregnant or nursing women;
* Previous organ transplants or allogeneic hematopoietic stem cell transplants;
* Under treatment of immunosuppressants, including but not limited to cyclosporine, tacrolimus, corticosteroids, etc., within 1 month prior to sampling;
* Fever (temperature \>37.5 ℃) within 1 month prior to sampling, or using antibiotics due to respiratory, gastrointestinal, urinary tract infections, etc.;
* Other situations in which the researchers consider it inappropriate for the patient to participate in this study.
Evaluating Positron Emission Mammography Imaging of Suspicious Breast Abnormalities

The goal of this pilot project is to test the new Radialis Positron Emission Mammography (R-PEM) system in breast cancer patients that has a higher sensitivity with lower radiation doses than conventional PET/CT.

The plan for the pilot study is to image patients who are already scheduled for diagnostic imaging for breast cancer after a positive core biopsy. Participants will be injected with 5mCi (millicurie) of F18-Fluorodeoxyglucose (FDG) and patient will wait for a couple of hours for uptake of FDG. After this time, the first R-PEM scan will occur. Additional optional R-PEM scans can be performed 4 hours after injection and 7 hours after injection with reductions in radiation emission.

Additionally, R-PEM images will be compared to standard-of-care breast Magnetic Resonance Imaging (MRI) and digital breast tomosynthesis (DBT) to study extension of disease and screening of contralateral breast.


Eligibility Criteria:
Inclusion Criteria:

* Subject is female of any race and ethnicity
* Subject is at least 26 years old
* Following routine mammography imaging, subject is categorized as BI-RADS score 4C or 5 because of calcifications, masses, asymmetries or/and architectural distortion will undergo additional tests including biopsy within 30 days of routine imaging
* Subject is female with a recent breast biopsy confirming breast cancer

Exclusion Criteria:

* Subject unable or unwilling to undergo informed consent
* Subjects who are unable or unwilling to tolerate any of the imaging tests because of claustrophobia, compression, etc.
* Subjects who are pregnant or who think they may be pregnant
* Subjects who are breast-feeding
* Subjects weight exceed table limits of MRI and PET-CT (300-450 lb or 135-205 kg)
* Subjects with history of allergic reaction to gadolinium or previous history of life-threatening anaphylactic reaction to any contrast.
* Claustrophobic subjects
Molecular Mechanisms of Raspberries Effect on Insulin Resistance and Inflammation

Red raspberries (Rubus idaeus) are a good source of health enhancing hydrolyzable and condensed tannins, flavonoids, anthocyanins, phenolic acids, rheosmin, potassium, carotenoids, vitamin C, and vitamin K1. Compared to other berries commonly consumed in the US, the health benefits of red raspberries to improve pre-diabetes mellitus (PDM) and type 2 diabetes have never been explored. The clinical study proposed in this project seeks to investigate the protective effect of whole red raspberries against insulin resistance, oxidative stress, and inflammation in PDM and type 2 diabetic patients. The in vitro study proposed in the project will assist in identifying the molecular mechanisms by which whole red raspberry protect islet cells against oxidative stress, insulin resistance and loss of cell function.


Eligibility Criteria:
Inclusion Criteria:

* type 2 diabetes

Exclusion Criteria:

* hypoglycemic agents
* Pregnant or nursing a child
* chronic medication that does not have a stable dose for greater than one month
* anti-inflammatory medication
* inflammatory disease
A Comparison of Contact Aspiration Versus Stent Retriever for Acute Basilar Artery Occlusion

Compare the effectiveness and safety of contact aspiration (CA) and stent retriever (SR) in acute ischemic stroke patients with basilar artery occlusion.


Eligibility Criteria:
Inclusion Criteria:

1. Age≥18 years;
2. Acute basilar artery occlusion confirmed by CTA/MRA/DSA;
3. Last known well to puncture time≤24 hours;
4. pc-ASPECTS score≥6 points;
5. Baseline NIHSS score≥10 points;
6. Consent to endovascular treatment;
7. Informed consent signed.

Clinical Exclusion Criteria:

1. Baseline mRS≥3 points;
2. Known or suspected severe basilar artery stenosis (\>70%) or chronic occlusion based on history, imaging, or clinical manifestations;
3. Refractory hypertension that is difficult to be controlled by drugs (defined as persistent systolic blood pressure \>185 mmHg or diastolic blood pressure \>110 mmHg)
4. Genetic or acquired hemorrhagic tendency, coagulation factor deficiency or on anticoagulant therapy and International Normalized Ratio (INR) \> 3.0;
5. Laboratory tests: baseline blood glucose \<50mg/dl (2.8mmol/L) or \>400mg/dl (22.2mmol/L); Baseline platelet count \<50×109/L;
6. Known severe allergy (more severe than skin rash) to contrast agents uncontrolled by medications;
7. Females who are pregnant, or those of childbearing, potential with positive urine or serum beta Human Chorionic Gonadotropin test;
8. Other circumstances that the investigator considers inappropriate for participation in the trial or that may pose significant risks to patients (such as inability to understand and/or follow the study procedures and/or follow up due to mental disorders, cognitive or emotional disorders).

Imaging Exclusion Criteria:

1. CT or MR evidence of acute intracranial hemorrhage (the presence of microbleeds on MRI is allowed);
2. Midline shift or herniation, mass effect with effacement of the ventricles;
3. Complete cerebellar infarct on CT or MRI with significant mass effect and compression of the 4-th ventricle;
4. Complete bilateral thalamic infarction on CT or MRI;
5. Inability to endovascular treatment due to Excessive tortuosity, variation, or dissection of the artery;
6. Subjects with occlusions in both intracranial vertebral arteries;
7. Subjects with occlusions in both anterior and posterior circulation;
8. Evidence of intracranial tumor (except small meningioma).
Acoustic Cardiographic Assessment of Heart Function and the Role of Phrenic Nerve Stimulation

In this study, the investigators sought to determine whether a stimulation of the phrenic nerve affects heart function. Heart function is assessed by acoustic cardiography.

Patients who need temporary pacing following open heart surgery and who are willing to participate receive a phrenic nerve electrode during the operation. Heart function is postoperatively assessed by acoustic cardiography (Audicor, Inovise Medical Inc., Portland, USA) during different forms of pacing (right ventricle, left ventricle, biventricular; AAI, DDD) and with or without phrenic nerve stimulation. Acoustic cardiography simultaneously integrates heart sounds and single-channel electrocardiography input to generate multiple parameters that correlate to established hemodynamic measures. Effects of phrenic nerve stimulation on heart function will be analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Patients following open heart surgery who need temporary pacing

Exclusion Criteria:

* Patients with permanent pacemakers
* Patients with fast changing need of vasopressor therapy
Singing and Cardiovascular Health in Older Adults

Cardiovascular disease (CVD) claims more lives each year than cancer and chronic respiratory disease combined. Participation in cardiac rehabilitation (CR) reduces mortality and risk of a major cardiovascular event in secondary prevention populations, including older adults. Older adults are less likely to participate in CR, as comorbidities in this population, including arthritis and chronic obstructive pulmonary disease, make participation difficult. Singing is a physical activity that involves components of the vagal nerves manifested as changes in cardiac autonomic regulation. Unlike physical exercise, the effects of singing on cardiovascular health has not been well-studied. The hypothesis for this project is that older patients with CVD will have favorable improvement in cardiovascular biomarkers, including, endothelial function and heart rate variability (HRV), after 30 minutes of singing.

This proposal seeks to create, optimize and test two different singing interventions in older patients with CVD. The study will consist of three arms, according to a randomized, single-blind, crossover, sham procedure-controlled design. Sixty-five total participants will each have three visits on three different occasions for the following interventions:

1. a 30-minute period of guided singing from an in-person music therapist
2. a 30-minute period of singing along to an instructional video including a professor of voice and "inexperienced, older singing student"
3. a 30-minute sham intervention (subjects will undergo a hearing test)

The goal will be to determine which singing intervention, if any, is superior to the other - as this would be important to guide longer and larger clinical trials in the field. Knowledge gained from this proposal will improve understanding of biologic mechanisms of singing behaviors, as it relates to CVD.

Eligibility Criteria:
Inclusion Criteria:

* English Speaking
* Have a history of coronary artery disease (defined as history of myocardial infarction, coronary stenosis \>50%, percutaneous coronary intervention with stent placement, balloon angioplasty, or coronary arterial bypass grafting)

Exclusion Criteria:

* Subjects with a permanent pacemaker or implantable cardioverter defibrillator (ICD) implanted
* Patients with a history of atrial fibrillation, flutter or atrial tachycardia
* Parkinson's disease or a tremor
* Amputated upper extremity or presence of upper-arm (dialysis) fistula
* Fingernail onychomycosis (fungal infections resulting in thickening of the nails)
* Pregnancy
* Current illicit drug use (marijuana, tobacco, cocaine, amphetamines, etc.)
* Current excessive alcohol use (defined as more than 14 drinks/week for women, more than 28 drinks/week for men)
* Unstable coronary heart disease (active symptoms of chest discomfort)
* History of a Stroke or TIA or peripheral arterial disease
* Known history of cognitive impairment or inability to follow study procedures
* Cancer requiring systemic treatment within five years of enrollment.
* Subjects requiring supplemental oxygen use
* Non-English speaking subjects (video with lyrics are taped in English)
Effect of 6 Weeks Daily Consumption of a Cereal-based Juice Beverage on Gastrointestinal Health

The project is a randomized, 2-way, blinded parallel trial in which 56 healthy adults of both genders with frequent occurrence of stomach trouble.This intervention trial with 6 weeks of daily intake β-glucans will be carried out with a beverage containing β-glucans and a control beverage without β-glucans. The primary aim is to investigate whether β-glucans from barley has an effect on stomach and intestinal health, including stool volume and frequency. Microbiota, concentrations of short chain fatty acids (butyrate, propionate, acetate), calprotectin, and energy and fat content in feces. Furthermore, blood pressure and exhaled hydrogen and methane, before and after the intervention, subjective perception of gastrointestinal problems and digestion as well as the participants' attitudes towards functional foods are measured using Visual Analog Scale (VAS).

Further, specific metabolites of β-glucans in urine (exploratory endpoint) and certain toxic metabolites from the microbiota using metabolite profiling (metabolomics) are also analyzed

β-glucans from barley slows gastric emptying rate and prolongs the transit time of food in the small intestine." The relatively undigested β-glucans have the ability to increase satiety and stimulate digestion, ensuring regular bowel movements and relieve sluggish bowel movements, including constipation and constipation. β-glucans are fermented down in the large intestine, resulting in production of short-chain fatty acids which inhibit the biosynthesis of cholesterol, hence blood cholesterol levels are lowered (not the goal here). Subsequently, β-glucans may also affect blood pressure. As a direct result of the effects in the intestine, there will be an improvement in the quality of life for people with stomach upsets and maybe a reduction in the risk of cardiovascular disease.

Eligibility Criteria:
Inclusion Criteria:

* BMI 20 - 27 kg/m2
* Like test and control drink, pasta, meat sauce as these foods are part of the test meal.
* Healthy subjects sometimes or often bothered by mild gastric problems such as bloating, loose stools or constipation
* Willing to handle in 2 x 3-day total feces at the start and end of the study

Exclusion Criteria:

* Suffering from irritable bowel syndrome (IBS), bacterial overgrowth in the small intestine (SIBO) or inflammatory bowel disease (IBD).
* Systemic infections, psychiatric or metabolic diseases, and any clinical condition
* Chronic or frequent use of medication (including blood thinners, excluding contraceptives)
* Frequent loose stools
* Blood donations during or in the month leading up to the study period
* Elite athletes (\> 10 hours of hard exercise / week, self-reported)
* High intake of alcohol (defined as a weekly intake of \> 7 units for women and \> 14 units for men),
* Have or have had a drug addiction
* Participation in other scientific studies during the study period
* Lactating
* Pregnancy or ongoing planning of pregnancy
* Vegetarianism or veganism.
Evaluation of Occupational Burnout and Stress Among Dentists in Covid-19 Pandemic

The aim of this study was to evaluate the factors affecting the ability and willingness of dentists to work during the COVID-19 pandemic and the effect of this situation on occupational burnout. A 51-question survey, including demographic and pandemic questions and the Maslach Burnout Inventory (MBI), was used as a data collection method and administered to dentists in Turkey via the internet in two stages. A link to the survey (onlineanketler.com) was sent to the participants by e-mail or social media (WhatsApp©). A total of 706 participants were included in the study. The second stage of the survey only applied to dentists who are assigned within the scope of COVID-19 measures in Turkey.


Eligibility Criteria:
Inclusion Criteria:

* All dentist working during the COVID-19 outbreak
* Accepted electronically to participate in our study
* Completed and submitted our electronic questionnaires successfully

Exclusion Criteria:

* Non-dentists
* Did not accept electronically to participate in our study
* Did not complete not submitted our electronic questionnaires successfully
The Relationship Between Hormone Sensitivity and Imaging of Idiopathic Interstitial Pneumonia by Artificial Intelligence

Application of artificial intelligence deep learning algorithm to analyze the relationship between hormone sensitivity of idiopathic interstitial pneumonia and imaging features of high resolution CT.

Methods: the medical records and chest high-resolution CT images of patients with idiopathic interstitial pneumonia admitted to the respiratory department of the Third Hospital of Peking University from June 1, 2012 to December 31, 2020 were retrospectively analyzed.Application of artificial intelligence deep learning neural convolution network method to create recognition technology of different imaging features.Including ground glass, mesh, honeycomb, nodule or consolidation, the model was established. IIP patients were divided into hormone sensitive group and hormone insensitive group according to whether the use of hormone was effective or not.Logistic regression analysis was used to analyze the correlation between statistically significant parameters and hormone sensitivity.Artificial intelligence was used to establish the correlation model between imaging features and clinical data and hormone sensitivity.

Eligibility Criteria:
Inclusion Criteria:

Clinical-pathological-radiology diagnosis of idiopathic interstitial pneumonia Hormone therapy was used; The follow-up data were complete, and the effect of hormone use could be judged.

Exclusion Criteria:

Lung infection disease; Heart failure; Connective tissue disease; IIP Without hormone therapy ; IIP but the follow-up data were incomplete, and the effect of hormone use could not be judged.
Effectiveness of Cognitive-Affective Behavior Therapy for the Treatment of Somatization Disorder

This study will examine the long-term effect of cognitive-affective behavior therapy on the physical symptoms, functioning, and health care utilization of people with somatization disorder.

Somatization disorder is a syndrome characterized by the presence of multiple medically unexplained physical symptoms. It often results in substantial functional impairment and the need for extensive medical treatment. Neither pharmacological nor psychosocial treatments for the disease have demonstrated clinical success. People with somatization disorder may benefit from a treatment that integrates emotion-centered strategies into cognitive behavioral therapy. The long-term effectiveness of this treatment has not been established, however. This study will examine the long-term effect of cognitive-affective behavior therapy on the physical symptoms, functioning, and health care utilization of people with somatization disorder.

Participants in this open-label study will be randomly assigned to receive either cognitive-affective behavior therapy (CABT) or standard medical care that is augmented by a psychiatric consultation. Treatment will last 4 months. Assessments of somatic symptomatology, functional impairment, and health care costs will occur at screening, baseline (1 to 2 weeks after screening), and 4, 10, and 16 months after baseline. The visits at 10 and 16 months post-baseline will assess specifically the long-term efficacy of the treatment.

Eligibility Criteria:
Inclusion Criteria:

* Meets DSM-IV criteria for somatization disorder
* Available for follow-up over the ensuing 18 months
* English-speaking

Exclusion Criteria:

* Meets DSM-IV criteria for a psychotic disorder, organic brain syndrome, or psychoactive substance dependence (Other psychiatric comorbidity is not exclusionary)
* Active suicidal ideation
* Unstable major medical condition
* Plans to engage in additional psychotherapy during the first 6 months after enrollment
* Current use of any medication that has not been stabilized for the previous 2 months
AZD2066 Cocktail Study

The aims of this study are to examine the effect of repeated doses of AZD2066 and of caffeine, bupropion, tolbutamide, omeprazole, metoprolol and midazolam on the blood concentrations of each other


Eligibility Criteria:
Inclusion Criteria:

* Provision of informed consent prior to any study-specific procedures
* Healthy volunteers with BMI between 18 and 30 kg/m2
* Medical and surgical history and physical examination without any clinically significant findings
* Non smokers or past smokers who have stopped smoking within the last 6 months.

Exclusion Criteria:

* History of previous or ongoing psychiatric disease/condition including psychosis, affective disorder, anxiety disorder, personality disorder or other significant psychiatric disorders or any other major disorder that may interfere with the objectives of the study, as judged by the Investigator
* Clinically significant illness as judged by the Investigator, within four weeks before the first administration of investigational product.
* Female subjects who have a positive pregnancy test or who are pregnant or breast-feeding