cyrilzakka/clinical-trials huggingface dataset:
Biomarkers in Patients With High-Risk Melanoma Receiving High-Dose Interferon Therapy

RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors identify biomarkers related to cancer and predict how patients will respond to treatment.

PURPOSE: This research study is looking at biomarkers in patients with high-risk melanoma receiving high-dose interferon therapy.

OBJECTIVES:

* To screen serum specimens using a high throughput protein profiling platform that tests for the highest number of known biomarkers (detectable by antibodies) that could be predictors of response to interferon treatment, autoimmunity, and disease outcome in patients with high-risk melanoma undergoing high-dose interferon (IFNa2b) therapy .
* To compare soluble factors across all patients at each time point (baseline and during therapy).
* To compare pre-therapy vs post-therapy serum samples from these patients.
* To assess the kinetics of soluble factors' appearance, persistence, and disappearance during the 12 months of therapy.
* To assess whether the amount of specific soluble factors in the pre-therapy sample is predictive of response independent of therapy.
* To correlate statistically significant factors with S100 and autoimmunity in these patients.
* To confirm the data obtained with the Luminex technology.

OUTLINE: Patients are stratified according to survival (\< 2 years vs \> 5 years).

Blood samples collected from patients enrolled in E-1694 are analyzed using high throughput protein profiling by ELISA to compare changes in levels of putative biomarkers of interferon alfa-2b, including cytokines and paired receptors, chemokines, cell adhesion molecules, metalloproteinases, angiogenic markers, growth factors, soluble receptors, signal transduction molecules, hormones, and other biomarkers of disease and dysregulated immune processes, at baseline and during therapy.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of high-risk melanoma
* Receiving interferon alfa-2b therapy in arm II of clinical trial E-1694

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Effectiveness and Acceptability of MoodGYM in Treating Depressive Symptoms in Chinese Americans

This study aims to evaluate efficacy and acceptability of the Chinese language version of MoodGYM as a therapeutic intervention in treating symptoms of depression in community dwelling Chinese Americans in the Boston area.

Hypothesis 1: Participants enrolled in MoodGYM will show a significant decrease in depressive symptoms after completion of the 5 modules.

Hypothesis 2: Participants enrolled in MoodGYM will show significantly improved dysfunctional thinking.

Hypothesis 3: Participants enrolled in MoodGym will rate this program as culturally acceptable.


Eligibility Criteria:
Inclusion Criteria:

* Resident of the US, but self-identified as Chinese origin
* At least 18 years of age
* Proficiency in Chinese, including the ability to read Chinese
* Access to computer and internet
* Scores \> 10 on the Chinese bilingual patient health questionnaire -9 item (PHQ-9)

Exclusion Criteria:

* Current ongoing psychiatric or psychological treatment
* Using illicit drugs or consumption \> 3 standard drinks in a day
* Currently experiencing a psychotic illness
* Past or current history of schizophrenia or bipolar disorder
* ECT during the last year
* Current active suicidal or self-injurious potential necessitating immediate face-to-face treatment
Does the Bioactive Substance in Coffee, Cafestol, Have Preventive Properties on Type-2-diabetes? (Acute Substudy)

Acute, double-blinded, randomized, cross-over cafestol intervention study with fifteen participants with a large waist circumference participating in three OGTTs.

The study is a acute, double-blinded, randomized, controlled intervention in 15 subjects with abdominal obesity at high risk of developing T2D. Initially, a blood sample is obtained (t=-15 min) and at time point 0, the participants will ingest a capsule containing either 6 or 12mg cafestol or placebo. Immediately hereafter an OGTT commences with ingestion of a 75 g glucose solution. In the following 2 hours blood samples are collected at time points 15, 30, 60, 90, 120 and 180 min. The samples will be used for determination of plasma glucose, insulin and cafestol, as well as GLP-1 and GIP. After a one-week washout period, the subject will undergo the same set-up again, however now with the different dosage of cafestol or placebo. The process is repeated for three weeks until every subject has undergone both interventions and the placebo.

Eligibility Criteria:
Inclusion Criteria:

25 \< BMI \< 40 kg/m2 Waist circumference \> 102 cm (men) / 88 cm (women)

Exclusion Criteria:

* Type 2 diabetes (HbA1c \> 48 mmol/mol) or in treatment with antidiabetic drugs
* Pregnancy
* Planned pregnancy
* Breastfeeding
* Significant comorbidity expected to unable the subject from completing visits
Cohort Project of Patients With Inflammatory Rheumatism

Chronic inflammatory rheumatism (CIR) is a group of inflammatory diseases that affect the joints and spine and are related to an abnormal immune response. CIR includes many different forms of arthritis that manifest as painful and swollen joints, stiffness, especially in the morning and persisting even after exercise, and limited joint mobility. CIR can also affect bones, cartilage, ligaments, tendons and muscles. Some may affect other organs. These symptoms can lead to a reduced quality of life, limited physical activity and progressive structural and functional deterioration of the joints.

Current treatment for CIR is aimed at reducing inflammation and relieving pain. Anti-inflammatory medications such as corticosteroids and non-steroidal anti-inflammatory drugs can be used to relieve pain and inflammation. Biotherapies can also be used to modify the progression of the disease. On the other hand, regular exercise can help strengthen the muscles that support the affected joints and improve mobility. Physical therapies, such as physical and occupational therapy, can also help improve mobility and relieve pain.

Although there is no definitive cure for CIR early and appropriate treatment can help reduce symptoms and improve quality of life, as well as avoid the risk of developing complications such as lung, cardiovascular, kidney, ophthalmic, liver and other diseases.

It is in this context, in order to better understand CIR to improve the global management of patients, and to analyze the evolution of CIR over time in relation to the different treatments proposed, that the interest in creating a database of patients with CIR arises.


Eligibility Criteria:
Inclusion Criteria:

* Patient over 18 years of age.
* Patients with rheumatoid arthritis meeting ACR/EULAR criteria or axial and/or peripheral spondyloarthritis meeting ASAS criteria.
* Patients who have failed or are intolerant of DMARDs (methotrexate or arava) for rheumatoid arthritis.
* Patients who have failed treatment with at least two NSAIDs for spondyloarthritis.
* Patients who require biologic/synthetic therapy or patients already receiving biologic or synthetic therapy.

Exclusion Criteria:

- Patient under curatorship.
PET/MRI Imaging of Glutamate Release in the Brain

Based on PET (18-PSS232) and MRI, glutamate release after N-acetylcystein challenge will be monitored in human brains.

Diagnostic trial with quantification of glutamate release in PET/MR.

Eligibility Criteria:
Inclusion Criteria:

* healthy volunteer

Exclusion Criteria:

* smoker
* drug addiction
* significant neurological or psychiatric conditions
Lactate Imaging as a Tumour Biomarker

This project is designed to investigate whether measurements of lactate in tumours, made using a magnetic resonance technique similar to MRI, is an effective non-invasive method to detect whether some new targeted drugs are having their desired effect.

The study hypothesis is that by using magnetic resonance spectroscopy techniques, we will be able to observe changes in tumour lactate levels in vivo, in response to treatment.


Eligibility Criteria:
Inclusion Criteria:

Cohort 1:lymphoma patients

* minimum lesion size of 2cm
* not pretreated but scheduled to be treated with CHOP (Cyclophosphamide, Hydroxydaunomycin,Oncovin and Prednisolone)

Cohort 2:Colorectal patients

* metastatic disease of at least 2cm
* not pretreated

Cohort 3:Phase 1 Drug Development

* minimum lesion size at least 2cm

Cohort 4: Brain

* primary brain tumours receiving radiotherapy and temozolomide
* cerebral lymphoma receiving standard chemotherapy

Exclusion Criteria:

* MRI incompatible metal implants
* Claustrophobia
* Inability to tolerate a 40 minute MRI scan
Neuropathic Pain in Elderly People With Diabetes: Impact on Quality of Life and Cognition

This study was set out 1) Evaluate the impact of Diabetic Peripheral Neuropathy (DPN) and DPN-P (Diabetic Peripheral Neuropathic Pain) on the overall Quality of Life (QoL) in elderly with Diabetic Mellitus (DM) and 2) Evaluate the association between cognition impairments and DM in the elderly, and the contributions of DPN and/or DPN-P


Eligibility Criteria:
Inclusion Criteria:

* Aged 50 or above
* Diagnosis of diabetes mellitus (Type 1 or Type 2)

Exclusion Criteria:

* major psychiatric conditions
* recent cardiovascular events within the last six months
* blindness radiculopathy
* spinal cord injury, multiple sclerosis
* carpal tunnel syndrome
* trigeminal neuralgia
* Subjects who were incompetent in giving written consent
Molecular Detection Of Efflux Pump and Virulence Factors Genes in Pseudomonas Aeruginosa

Pseudomonas aeruginosa (PA) is a ubiquitous aerobic, non-fermentative Gram-negative rod that is widely associated with nosocomial pneumonia and can lead to severe illness with poor outcomes, particularly in critically ill people due to the ability of some strains to cause lung epithelial injury and spread into the circulation. 2 In the intensive care unit, PA infection is ranked among the top five causes of the bloodstream, pulmonary, surgical site, urinary tract, and soft tissue infections.

The pathogenesis of PA infections is multifactorial, and it is frequently complicated by the bacteria's intrinsic resistance to some antimicrobial agents such as sulfonamides, tetracyclines, and trimethoprim, as well as its ability to acquire or quickly develop resistance to major classes of antibiotics such as aminoglycosides, quinolones, B-lactams, and polymyxins (Bassetti et al., 2018).

The efflux systems, which mediate the expulsion of antibiotics out of the cell shortly after entry, the production of enzymes to inactivate antibiotics, and the decrease in permeability across the cell wall are some mechanisms used by PA to develop antimicrobial resistance (Meletis \& Bagkeri, 2013).

PA possesses a large number of virulence factors that play a significant role in pathogenesis and the determination of infection severity. These virulence factors act alone or in synergy with each other to cause tissue damage, necrosis, and cell death. Among the virulence factors of PA, the major determinants of virulence are the type III secretion system (T3SS) and quorum sensing (cell-to-cell signaling system). The T3SS is a needle-like complex, also known as the injectisome, that enables a bacterium to deliver different effector proteins such as ExoS, ExoT, ExoU, and ExoY across the membrane into a host cell, altering host cell functions and increasing bacterial survival rates ( Horna G and, Ruiz J, 2021). In this study, we aimed to evaluate the prevalence of antibiotic resistance caused by the presence of Efflux genes and some virulence factors in Pseudomonas aeruginosa from clinical isolates.

Eligibility Criteria:
Inclusion Criteria:

* All patients suffering from infections that can be caused by pseudomonas aeruginosa

Exclusion Criteria:

* Samples diagnosed to have organisms other than pseudomonas aeruginosa.
A Trial Comparing Ferumoxytol to Iron Sucrose for the Treatment of Iron Deficiency Anemia in Adult Subjects With Chronic Kidney Disease

The purpose of the study is to evaluate the safety and efficacy of intravenous (IV) ferumoxytol compared to IV iron sucrose for the treatment of iron deficiency anemia (IDA) in participants with chronic kidney disease (CKD).


Eligibility Criteria:
Inclusion Criteria:

Key Inclusion Criteria include:

1. Males and females ≥18 years of age
2. An estimated glomerular filtration rate \<60 mL/minute or a diagnosis of CKD (such as nephropathy, nephritis)
3. Hemoglobin \<11.0 g/deciliter (dL)
4. Transferrin saturation \<30%
5. Hemodialysis participants on maintenance dialysis for at least 3 months prior to screening and currently receiving dialysis 3 times per week
6. Female participants of childbearing potential who are sexually active must be on an effective method of birth control for at least 1 month prior to screening and agree to remain on birth control until completion of the study

Exclusion Criteria:

Key Exclusion Criteria include:

1. History of allergy to IV iron
2. Allergy to 2 or more classes of drugs
3. Female participants who are pregnant or intend to become pregnant, breastfeeding, within 3 months postpartum, or have a positive serum or urine pregnancy test
4. Hemoglobin ≤7.0 g/dL
5. Received another investigational agent within 4 weeks prior to screening, or planned receipt of an unspecified investigational agent during the study period
6. Known causes of anemia other than iron deficiency (such as hemolysis and vitamin B12 or folate deficiency)
Immunonutrition for Improving the Efficacy of Immunotherapy in Patients With Metastatic Non-small Cell Lung Cancer

The present study was designed to evaluate the efficacy of the early systematic provision of oral nutritional supplements enriched in immunonutrients in non-small lung cancer patients undergoing immunotherapy and receiving nutritional counseling


Eligibility Criteria:
Inclusion Criteria:

* Confirmed histological diagnosis of metastatic non-small cell lung cancer (both squamous and non-squamous histology);
* First-line treatment with immunotherapy (alone or in combination with chemotherapy) for metastatic disease by investigators' choice within the framework of good clinical practice and in agreement with current guidelines;
* Will to participate by providing written informed consent;
* Availability to administer oral supplements and immunotherapy with or without chemotherapy;
* Eastern Cooperative Oncology Group Performance Status ≤ 2;
* Life expectancy ≥ 6 months.

Exclusion Criteria:

* Age \< 18 years;
* Inability to sign an informed consent;
* Indication to or ongoing artificial nutrition support (totally compromised spontaneous food-intake) and incapacity or unavailability to consume oral nutritional supplements
Efficacy and Safety of Ursodeoxycholic Acid in Reversing Gastric Intestinal Metaplasia

The goal of this clinical trial is to investigate the efficacy of ursodeoxycholic acid in treating gastric intestinal metaplasia in Helicobacter pylori-negative adults. It will also learn about the safety of ursodeoxycholic acid. The main questions it aims to answer are:

Does ursodeoxycholic acid promote the regression of IM in individuals without Helicobacter pylori infection? What medical problems do participants experience when taking ursodeoxycholic acid? Researchers will compare ursodeoxycholic acid to a placebo (a look-alike substance that contains no drug) to see if ursodeoxycholic acid is effective in treating gastric intestinal metaplasia.

Participants will:

Take ursodeoxycholic acid or a placebo every day for 6 months. Visit the clinic once every 4 weeks for checkups and tests.


Eligibility Criteria:
Inclusion Criteria:

* patients aged from 18 to 75 years old.
* patients with OLGIM stage Ⅱ-Ⅳ diagnosed by upper gastrointestinal endoscopy and histopathological examination within the last 3 months.
* patients without Helicobacter pylori infection, including patients who had successful Helicobacter pylori eradication before enrollment.

Exclusion Criteria:

* a history of regular use (defined as at least once per week) of non-steroidal anti-inflammatory drugs (NSAIDs) and/or statins.
* a history of stomach surgery (including endoscopic submucosal dissection and endoscopic mucosal resection) or previously diagnosed malignant tumor.
* a history of heart failure, renal failure, liver cirrhosis or chronic hepatic failure; patients with contraindications or allergies to the drugs in this study.
* breastfeeding or pregnancy.
* a history of substance abuse or alcohol abuse within the past one year.
* patients with severe mental illness.
* refusal to undergo drug treatment.
* refusal to sign informed consent.
Developing Advanced Blood-Brain Barrier Permeability Imaging for Early AD

Aging is the primary risk factor in aging-related dementia. An important initiating factor for the development and progression of cognitive impairment is disruption of the blood-brain barrier (BBB). BBB plays an important role in maintaining normal brain homeostasis and protecting neural tissues from toxins. It is hypothesized that such changes known to be common in aging and can be an early process that precedes Alzheimer's Disease (AD). The microvascular changes related to subtle BBB disruption can be measured with permeability-surface area (PS) derived from GRASP DCE-MRI acquired less than 10 minutes, and the patterns of increased PS in normal and abnormal aging are different.


Eligibility Criteria:
Inclusion Criteria:

* Subjects that have been diagnosed with aMCI ages 65-85

Exclusion Criteria:

* Pregnant, planning to get pregnant, or nursing.
* Claustrophobia
* Cardiac pacemaker
* Intracranial clips, metal implants, unremovable jewelries, metal in eyes.
* History or presence of any other major medical, neurologic or psychiatric conditions, such as Alzheimer's diseases, Parkinson's diseases, and stroke.
* Renal or liver disease as this may cause concerns related to Gad-based contrast agent
* Allergy to the contrast agent Gadolinium
Salvage Ovarian FANG™ Vaccine + Carboplatinum

This is a Phase II study of Vigil™ autologous tumor cell vaccine integrated with carboplatinum. All patients will have Vigil™ prepared and stored from ovarian tumor cells obtained at the time of primary surgical debulking. Patients meeting eligibility criteria will receive either carboplatinum alone (AUC 6/30 minute infusion) or carboplatinum (AUC 5/30 minute infusion) and taxol (175 mg/m2/3 hour infusion) one day prior to Vigil™ 1.0 x 10e7 cells/intradermal injection, once every 3 weeks.


Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed papillary serous or endometrioid ovarian cancer.
2. Previous randomization to Gradalis, Inc. protocol CL-PTL 105; observation arm (Group B) or or patients with vaccine prepared for CL-PTL 105 but did not otherwise qualify.
3. Recurrent cisplatinum-sensitive disease (defined as the appearance of any measurable or evaluable lesion or as asymptomatic CA-125 levels greater than 100 u/mL at two consecutive measurements after a 6 month period after platinum treatment.
4. Successful manufacturing of 4 vials of Vigil™ vaccine.
5. Recovered from all clinically relevant toxicities related to prior therapies.
6. ECOG PS 0-2 prior to Vigil™ vaccine administration.
7. Normal organ and marrow function as defined below:

   1. Absolute granulocyte count ≥ 1,500/mm3
   2. Absolute lymphocyte count ≥ 200/mm3
   3. Platelets ≥ 100,000/mm3
   4. Total bilirubin ≤ 1.5 x ULN
   5. AST(SGOT)/ALT(SGPT)/alkaline phosphatase ≤ 2.5 x ULN
   6. Creatinine \< 1.5 mg/dL
8. Patients must be off all "statin" drugs for ≥ 2 weeks prior to initiation of therapy.
9. Ability to understand and the willingness to sign a written informed protocol specific consent.

Exclusion Criteria:

1. Surgery involving general anesthesia, chemotherapy, radiotherapy, steroid therapy, or immunotherapy within 4 weeks prior to vaccination. Chemotherapy within 3 weeks prior to vaccination. Steroid therapy within 1 week prior to vaccination.
2. Patient must not have received any other investigational agents within 4 weeks prior to study entry.
3. Patients who require parenteral hydration of nutrition and have evidence of partial bowel obstruction or perforation.
4. Patients with history of brain metastases.
5. Patients with compromised pulmonary disease.
6. Short term (\<30 days) concurrent systemic steroids ≤ 0.25 mg/kg prednisone per day (maximum 7.5 mg/day) and bronchodilators (inhaled steroids) are permitted; other steroid regimens and/or immunosuppressives are excluded.
7. Prior splenectomy.
8. Prior malignancy (excluding nonmelanoma carcinomas of the skin and carcinoma in situ cervix) unless in remission for ≥ 2 years.
9. Kaposi's Sarcoma.
10. Patients with peripheral neuropathy ≥2 (paclitaxel).
11. Uncontrolled infection or psychiatric illness/social situations that would limit compliance with study requirements.
12. Patients with known HIV.
13. Patients with chronic Hepatitis B and C infection.
14. Patients with uncontrolled autoimmune diseases.
The WOW Project (WOW): Wonders Of The World Through Virtual Reality for Hospitalized Children

Hospitalized pediatric patients are unable to leave the hospital to engage in traditional learning environments. Patients often feel depressed, disconnected from learning, and socially withdrawn. The Stanford Chariot Program proposes a partnership with the Palo Alto Unified Hospital School at Stanford Children's Health to reignite patients' emotional well-being through learning. The WOW Project aims to use virtual reality (VR) to travel with hospitalized children to the Wonders of the World (WOW). Combining this immersive learning modality with complementary hands-on activities at the bedside, the investigators will transport them from their hospital room into a nurturing virtual environment to stimulate their emotional, mental, and social growth while they are physically healing. The investigators will evaluate their overall joy and awe of learning by using standardized emotional scales.


Eligibility Criteria:
Inclusion Criteria:

* Between the age of 5 and 17.
* English speaking.
* Anticipated in-patient stay for more than 1 day.

Exclusion Criteria:

* Legal guardian not present to obtain consent
* Child with a significant neurological condition, or major developmental disability
* Child with active infection of the face or hand
* A history of severe motion sickness
* A history of seizures caused by flashing light
* Major surgery within the last 12 hours