cyrilzakka/clinical-trials huggingface dataset:
Antineoplaston Therapy in Treating Patients With Stomach Cancer

Current therapies for Stomach Cancer provide very limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of Stomach Cancer.

PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on patients with Stomach Cancer.

Stomach Cancer cancer patients receive gradually escalating doses of intravenous Antineoplaston therapy (Atengenal + Astugenal) until the maximum tolerated dose is reached. Treatment continues up to12 months in the absence of disease progression or unacceptable toxicity.

OBJECTIVES:

* To determine the efficacy of Antineoplaston therapy in patients with Stomach Cancer, as measured by an objective response to therapy (complete response, partial response or stable disease).
* To determine the safety and tolerance of Antineoplaston therapy in patients with Stomach Cancer.
* To determine objective response, tumor size is measured utilizing MRI scans, which are performed every 8 weeks for the first two years, every 3 months for the third and fourth years, every 6 months for the 5th and sixth years, and annually thereafter.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically proven adenocarcinoma of the stomach that is unlikely to respond to existing therapy, including surgery, radiotherapy, and chemotherapy

  * Evidence of tumor by MRI, CT scan, chest x-ray, or radionuclide scan

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* Karnofsky 60-100%

Life expectancy:

* At least 2 months

Hematopoietic:

* WBC at least 2,000/mm\^3
* Platelet count at least 50,000/mm\^3

Hepatic:

* No hepatic insufficiency
* Bilirubin no greater than 2.5 mg/dL
* SGOT and SGPT no greater than 5 times upper limit of normal

Renal:

* No renal insufficiency
* Creatinine no greater than 2.5 mg/dL
* No history of renal conditions that contraindicate high dosages of sodium

Cardiovascular:

* No known chronic heart failure
* No uncontrolled hypertension
* No history of congestive heart failure
* No history of other cardiovascular conditions that contraindicate high dosages of sodium

Pulmonary:

* No serious lung disease, such as chronic obstructive pulmonary disease

Other:

* Not pregnant or nursing
* Fertile patients must use effective contraception during and for 4 weeks after study participation
* Not a high medical or psychiatric risk
* No concurrent nonmalignant systemic disease
* No active infection

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* At least 4 weeks since prior immunotherapy
* No concurrent immunomodulating agents

Chemotherapy:

* At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered

Endocrine therapy:

* Concurrent corticosteroids allowed

Radiotherapy:

* At least 8 weeks since prior radiotherapy and recovered

Surgery:

* Recovered from prior surgery

Other:

* Prior cytodifferentiating agents allowed
* No other concurrent antineoplastic agents
PET Imaging of 68Ga-Her2-affibody in Tumors with High Her2 Expression

This project uses HER2 protein as the target group of radiodrugs to explore the diagnostic efficacy, safety and metabolic characteristics of 68Ga-Her2-affibody in the expression status of HER2, aiming to provide a new imaging method for the determination of HER2 status in breast cancer At the same time, it also provides new methods and means for early diagnosis, accurate staging, recurrence judgment, treatment decision-making and prognosis judgment of malignant tumors such as lung cancer, gastrointestinal cancer and bladder cancer, and provides scientific basis for precise treatment of malignant tumors.

This project uses HER2 protein as the target group of radiodrugs to explore the diagnostic efficacy, safety and metabolic characteristics of 68Ga-Her2-affibody in the expression status of HER2 in whole body cancer lesions, aiming to provide a new imaging method for the determination of HER2 status in breast cancer and supplement more overall information that is difficult to obtain by traditional core needle biopsy. At the same time, it also provides new methods and means for early diagnosis, accurate staging, recurrence judgment, treatment decision-making and prognosis judgment of malignant tumors such as lung cancer, gastrointestinal cancer and bladder cancer, and provides scientific basis for precise treatment of malignant tumors.

Eligibility Criteria:
Inclusion Criteria:

- patients with confirmed or suspected cancer; Signed written informed consent

Exclusion Criteria:

-
Multimodal IMAgery Characterization of Cardiac Damage and Severity After COVID-19 Infection

Coronavirus Disease 2019 (COVID-19) is an infection caused by Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2), which affects multiple organ system particularly the lung and heart. Indeed, SARS CoV-2 has various cardiac manifestations which are associated with higher mortality and morbidity. Cardiac involvement, based on elevated levels of myocardial enzymes, have been described in 20 to 30% of COVID-19 infection. However, the physiopathological mechanisms of myocardial injury remains unclear. Main hypothesis include inflammation and cytokine storm, hypercoagulability and vascular thrombosis, inflammation or stress leading to coronary plaque rupture (type I myocardial infarction), supply-demand mismatch and hypoxemia resulting in myocardial damage (type II myocardial infarction) ...

Two patterns can be identified : ischemic or non-ischemic pattern including myocarditis, stress induced cardiomyopathy, thrombo-embolic disease. However, the consequences of myocardial damage after confirmed COVID-19 infection are unknown at medium to long term prognosis.

Data are needed to identify myocardial damage and to guide effective therapies and follow-up (use of ACE inhibitor, beta-blockers, steroids...? ) In this study, the investigators proposed to collect multimodal cardiac imaging including MRI (Magnetic Resonance Imaging) and TTE (Transthoracic echocardiogram) in order to identify and characterize cardiac injury as ischemic or non-ischemic pattern, to better assess risk stratification and to guide effective therapies if necessary.


Eligibility Criteria:
Inclusion Criteria:

* Cardiac involvement confirmed : increase troponin level \> 50pg/ml or left ventricular dysfunction assessed by echocardiography during hospitalization for confirmed COVID-19 infection
* Absence of severe renal failure (CKD EPI \> 30ml/min/1.73m²)
* Cardic imaging (MRI and TTE) performed during 4 months from COVID-19 infection

Exclusion Criteria:

* Cardiovascular history (ischemic or valvular disease, dilated cardiomyopathy, cardiac surgery...)
* Vulnerable patient (pregnancy, adult under legal protection)
Evaluating the Efficacy of a Digital Platform to Deliver Comprehensive Treatment for Opioid Use Disorder

Buprenorphine Evaluation and Telehealth Study (BEaTS)

Comparison of retention in care between telehealth-based care and treatment as usual.

Evaluating the Usability, Efficacy and Commercial Utility of a Digital Platform to Deliver Comprehensive Treatment for Opioid Use Disorder

Phase I, Aim I: Completed (R44 DA050354). Advance Boulder Care's mobile platform development and obtain usability feedback from individuals with prior OUD treatment. Aim 1 was successfully completed during Phase I, meeting milestones for improving product usability and satisfaction while reducing treatment barriers.

Phase II, Aim 2: Compare study participants who enroll in Boulder Care (n = 100) to participants who enroll in treatment as usual (i.e., office-based buprenorphine) (n = 100) and assess buprenorphine retention at 48 weeks (primary outcome) and monitor a) transition from referral to treatment, b) care continuity, c) engagement in care, and d) satisfaction with care (secondary outcomes).

Phase II, Aim 3: Compare study participants who enroll in Boulder Care (n = 100) to participants who enroll in treatment as usual (i.e., office-based buprenorphine) (n = 100) and assess at baseline, 4, 12, 24, 36, and 48 weeks post treatment initiation opioid use (primary outcome) and monitor employment, housing stability, and criminal justice involvement (secondary outcomes).

Phase II Approach.

The COVID-19 pandemic has altered treatment and research for OUD. Phase II of the Small Business Innovation Research (SBIR) award "Evaluating the usability, feasibility and commercial utility of a digital platform to deliver comprehensive treatment for opioid use disorder" (R44 DA050354) takes advantage of further development of the Boulder Care platform and expands the testing of our digitally-delivered treatment.

To assure the quality and success of the Phase II award, a partnership with experienced National Institute on Drug Abuse (NIDA) investigators under the leadership of Todd Korthuis, MD, MPH, strengthens the application. The application is modified to take advantage of Dr. Korthuis' and his team's experience and access to the Oregon Health \& Science University (OHSU) Harm Reduction and Bridges to Recovery clinic (HRBR - pronounced "harbor") and buprenorphine prescribing at OHSU primary care clinics. The HRBR clinic offers low-barrier buprenorphine initiation and stabilization, linking patients to community providers for ongoing care. The clinic can provide referrals to facilitate recruitment to Boulder Care services and participation in the Phase II study.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older with a diagnosis of OUD
* Within 45 days of seeking buprenorphine prescription
* Have a working smartphone
* Speaks and understands English

Exclusion Criteria:

* Untreated mental or medical health conditions that, in the opinion of the patient, would preclude study participation
* History of allergic reaction to buprenorphine
* Impending incarceration
* Plans to move out of Oregon in next 12 months
Clinical Trial to Evaluate the Chronic Efficacy of OC-01 Nasal Spray on Signs of Dry Eye Disease (The MYSTIC Study)

The objective of this study is to evaluate the chronic safety and effectiveness of OC-01 Nasal Spray as compared to placebo on signs of dry eye disease (DED).

Study OPP-004 was a Phase 2, single-center, randomized, masked (including subjects, Investigators, and study site personnel), placebo-controlled study designed to evaluate the safety and efficacy of OC-01 (varenicline) nasal spray in adult subjects with DED. The study planned to randomize approximately 120 subjects at least 22 years of age with a physicians' diagnosis of Dry Eye Disease and meeting all other study eligibility criteria to receive an application of OC-01 or placebo BID for 12 weeks. Subjects who terminated early during the application period were asked to complete safety assessments (if the subjects agree) prior to study exit. Subjects who were terminated early from the study were not replaced.

Eligibility Criteria:
Inclusion Criteria:

* Have used and/or desired to us an artificial tear substitute for dry eye symptoms within 6 months prior to Visit 1

Exclusion Criteria:

* Have had any intraocular surgery (such as cataract surgery), extraocular surgery (such as blepharoplasty) in either eye within three months or refractive surgery (e.g. laser-assisted in-situ keratomileusis, laser epithelial keratomileusis, photorefractive keratectomy or corneal implant) within twelve months of Visit 1
* Have a history or presence of an ocular disorder or condition in either eye that would, in the opinion of the Investigator, likely interfere with the interpretation of the study results or participant safety such as significant corneal or conjunctival scarring; pterygium or nodular pinguecula; current ocular infection, conjunctivitis, or inflammation not associated with dry eye; anterior (epithelial) basement membrane corneal dystrophy or other clinically significant corneal dystrophy or degeneration; ocular herpetic infection; evidence of keratoconus; etc. Blepharitis not requiring treatment and mild meibomian gland disease that are typically associated with DED are allowed.
* Have a systemic condition or disease not stabilized or judged by the Investigator to be incompatible with participation in the study or with the lengthier assessments required by the study (e.g., current systemic infection, uncontrolled autoimmune disease, uncontrolled immunodeficiency disease, history of myocardial infarction or heart disease, etc.)
* Have a known hypersensitivity to any of the procedural agents or study drug components
* Have any condition or history that, in the opinion of the investigator, may interfere with study compliance, outcome measures, safety parameters, and/or the general medical condition of the subject
Poor Response to Monoclonal Therapy in Asthma

Asthma affects 8% of the entire population. 4-5% of asthma sufferers have severe asthma, characterised by recurrent exacerbations (worsening of symptoms leading to the person having a bout of corticosteroids and/or antibiotics), significant symptoms and lack of response to the most widely used therapy, corticosteroids.

There is now new types of treatments (antibody drugs) which are licensed to manage severe asthma such as Anti-IL5. There is evidence Anti-IL5 and other similar antibody drugs are effective at reducing asthma exacerbations and reduce the need for oral corticosteroids for those that have severe asthma.

However, some patients respond poorly to Anti-IL5 and the investigators would like to find out why this happens. It is hoped that the investigators can identify the mechanism of poor treatment response to Anti-IL5. It is also hoped that the investigators can understand why symptoms worsen to the point of requiring antibiotics and/or steroids (also known as an exacerbation) for those prescribed Anti-IL5.


Eligibility Criteria:
Inclusion criteria: case participants:

* Aged 18 - 80 years old
* Able to give informed consent
* All patients identified as being suitable for anti-IL5 therapy by the asthma MDT will be considered for study enrolment.

This assessment by the MDT for participants to be eligible includes:

* A measure of compliance with current asthma medication,
* Confirmation of asthma diagnosis
* Suitability for anti-IL5 therapy based on blood eosinophil counts,
* Asthma exacerbation rates
* Prednisolone dose.
* Confirmation of treatment requires at least two asthma specialists to agree that this is the correct course of action
* Patients must first demonstrate over 75% compliance with inhaled and/or oral corticosteroid therapy

The asthma MDT and difficult asthma clinic normally assess patients between 18-80 years so only patients in this age range will be approached.

All patients will be able to give informed consent for study participation.

Exclusion criteria: case participants:

• Pregnancy

Inclusion criteria: control participants:

* Aged between 18-80 years old.
* Able to give informed consent

Exclusion criteria: control participants:

* Pregnancy
* Underlying respiratory conditions
Global Real World Data in Patients With Advanced Thyroid Cancer on Standard of Care and Specialized Interventions- Registry of Oncologic Outcomes With Testing and Treatment.

The goal of this clinical research study is to learn about the barriers in the real world to accessing treatments for ATC. And to learn about how patients with ATC tolerate and respond to the commercially available medications for treatment of this disease, outside of a clinical study.

Primary Objectives:

The primary objective of this study is to compare overall survival (OS) between ATC patients treated at MDA versus outside of MDA using treatment regimens offered at MDA based on BRAF status and stage of the disease. We will gather prospective real-world, large-scale, comprehensive data on these patients who are unable to access traditional clinical trials but are treated with MDA regimens, assigned by stage and BRAF-status.

Secondary Objectives:

1. To evaluate effect of chemotherapy, immunotherapy, and radiation therapy on the quality of life for ATC survivors
2. To evaluate how factors such as health insurance and lack of coverage, adherence, and other sociodemographic characteristics influences patient outcomes.

Eligibility Criteria:
Inclusion Criteria:

All adult patients aged 18 years or older with anaplastic thyroid cancer or poorly differentiated thyroid cancer as their clinical and/ or histological diagnosis will be included.

Exclusion Criteria:

Patients who do not have anaplastic thyroid cancer or poorly differentiated thyroid cancer on their tumor tissue would be excluded.
Phase I/II Study of Genasense in Patients With Chronic Lymphocytic Leukemia

This non-randomized study will test the safety and effectiveness of Genasense in patients with CLL.

This study is a two-part phase I-II study. Part 1 will determine the MTD of Genasense in patients with CLL. This dose will then be tested in a non-randomized, multi-center, Phase II sequential clinical trial of Genasense used alone for treatment of patients with advanced CLL.

Pharmacokinetics of Genasense and kinetics of Bcl-2 down regulation and re-expression in CLL cells will be followed in selected patients.

Eligibility Criteria:
* Any age
* Must have received at least one chemotherapy regimen that included fludarabine
* Measurable disease
* At least 3 weeks since biological therapy or radiation therapy for chronic lymphocytic leukemia
* No previous stem cell transplantation
* At least 3 weeks since surgery
Peripheral Immune System in Individuals With Schizophrenia

The investigators are seeking healthy volunteers and people with schizophrenia or schizoaffective disorder for a clinical study of the immune system in psychotic disorders. This is an observational study, to understand the ways in which the immune system may be contributing to the disease process.

Genetic studies have linked the number of copies coding for C4 protein to risk for schizophrenia. Studies examining the amount of mRNA, the molecules that point to how much C4 protein is likely being made, found more C4 mRNA in the brains from individuals with schizophrenia. Studies in mice have suggested that expressing more C4 protein in the brain, specifically the A-type of C4, can result in abnormalities in behavior. However, researchers have also found that pathways that involve this protein in the blood to be abnormal in individuals even before they develop schizophrenia and hypothesize these abnormalities change the blood brain barrier. In this work, the researchers are hoping to understand the ways in which C4 protein is abnormal in the peripheral blood and how this may be contributing to the disease process in hopes of finding new ways of helping individuals with schizophrenia and possibly other mental health disorders. A major goal of this study is to collect blood tissue for ongoing translational study of pathophysiological mechanisms of schizophrenia.

Interested participants will be asked a series of questions about their medical and mental health history, be able to provide informed consent, undergo a urine toxicology screen and be willing to provide a blood sample.

Eligibility Criteria:
Inclusion Criteria for Subjects with schizophrenia and schizoaffective disorders:

* Schizophrenia or schizoaffective disorder diagnosis verified by interview
* Diagnosis or initiation of antipsychotic medication was within last 5 years

Inclusion Criteria for Healthy Controls:

* No known diagnosis of schizophrenia or schizoaffective disorder
* No history of depression, anxiety, bipolar disorder, PTSD, agoraphobia, panic disorder, or generalized anxiety disorder
* Negative assessment for psychotic symptoms on day of interview

Exclusion Criteria (for both groups):

* Participants have a history of bleeding disorders or are taking blood thinners.
* Participants have a history of epilepsy, known genetic disorders
* Immunocompromised state (eg., receiving immunosuppressive therapy, transplant).
* History of brain-related disease (eg., stroke)
* Any uncontrolled medical disorder such as cancer.
* History of substance abuse or positive urine toxicology screen (including test for marijuana) on the day of the blood draw
HOPE-Epilepsy Trial

This a multi-center study to examine whether supplementation with omega 3 fatty acids will reduce seizure frequency in patients with epilepsy .


Eligibility Criteria:
Inclusion Criteria:

* Patients with active Epilepsy

Exclusion Criteria:

* pregnant women or breastfeeding
To Study the Changes in Protein in Lung Cells of Asian Patients With Advanced Non-small Cell Lung Cancer (NSCLC)

The purpose of this study is to study the changes in protein in lung cells of Asian patients with advanced non small cell lung cancer.

A molecular epidemiology study in Asian patients with advanced NSCLC of adeno histology to assess EGFR mutation status.

Eligibility Criteria:
Inclusion Criteria:

* Histological or cytologically confirmed advanced Non small cell lung cancer of adeno histology NSCLC treatment naive Availability of cancer tissue or cytology sample

Exclusion Criteria:

* Involvement in the planning and/or conduct of the study Previous enrollment in the present study
Psychometric Properties of the International Trauma Interview (ITI) for ICD-11 PTSD and CPTSD

The aim of the project is to evaluate the psychometric properties (e.g. validity, reliability) of the International Trauma Interview (ITI) - German version. The ITI is a structured clinical interview that corresponds to the ICD-11 criteria for diagnosing both posttraumatic stress disorder (PTSD) and complex posttraumatic stress disorder (CPTSD).

Eligible participants from psychiatric inpatient and outpatient facilities in Switzerland who have provided informed will complete various self-report measures about trauma-related mental health complaints. In addition, the ITI will be conducted by a trained clinician. Lastly, information from the medical chart will be further used for scientific purpose. The overall assessment will take approximately 1-2 hours to complete.


Eligibility Criteria:
Study-specific Inclusion criteria

* Structured diagnostic procedures upon hospital entry not yet started, except for orienting assessments
* Able to give informed consent as documented by signature
* Able to understand and communicate in German Exclusion criteria
* Clinical signs for impaired cognitive abilities
* Other contraindications to undergo the clinical interview