cyrilzakka/clinical-trials huggingface dataset:
Early Detection of Pancreatic Cancer

The purpose of this study is to enable non-invasive early detection of pancreatic cancer in high-risk populations through the establishment of a machine learning model using plasma cell-free DNA fragmentomics. Plasma cell-free DNA from early stage pancreatic cancer patients and healthy individuals will be subjected to whole-genome sequencing. Features, such as cell-free DNA fragmentation, copy number variations and the status of KRAS gene mutation, will be assessed to generate this model.

The incidence of pancreatic cancer is insidious. Most patients were in advanced stage when diagnosed and could not be cured by surgery. Early diagnosis of pancreatic cancer through screening is so important. Early screening detection projects derived from liquid biopsy technology are not only limited to circulating DNA methylation markers, but have developed into multi-dimensional indicators for joint evaluation. This large-scale early detection study will randomly enroll 260 stage I/II/III pancreatic patients, 80 patients with pancreatic benign diseases and 156 age- and sex-matched healthy individuals upon providing written informed consent. Plasma samples will be collected and extracted cell-free DNA will be subjected to whole genome sequencing. We aimed to incorporate genome-wide copy number variations, cell-free DNA fragmentomics, and status of KRAS gene mutation into the development of a multimodal biomarker-based prediction model.

Eligibility Criteria:
Inclusion Criteria:

* Age minimum 18 years
* Participants must have histologically and/or cytologically confirmed stage I/II/III pancreatic cancer
* Full access to the patients' clinical and pathological records
* Ability to understand and the willingness to sign a written informed consent document
* Non-cancer controls are sex- and age-matched individuals without presence of any tumors or nodules or any other severe chronic diseases through systematic screening

Exclusion Criteria:

* Participants must not be pregnant or breastfeeding
* Participants must not have prior cancer histories or a second non-pancreatic malignancy
* Participants must not have had any form of cancer treatment before enrollment or plasma collection, including surgery, chemotherapy, radiotherapy, targeted therapy and immunotherapy
* Participants must not present medical conditions of fever or have acute or immunological diseases that required treatment 14 days before plasma collection
* Participants who underwent organ transplant or allogenic bone marrow or hematopoietic stem cell transplantation
* Participants with clinically important abnormalities or conditions unsuitable for blood collection
* Any uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, myocardial infarction, major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, or psychiatric illness/social situations that would limit compliance with study requirements or influence patient signing the written informed consent
Neoadjuvant Chemotherapy with or Without Talniflumate for the Treatment of Breast Cancer

RATIONALE:

Talniflumate, a prodrug of niflumic acid with significant anti-inflammatory properties, has emerged as a promising candidate in breast cancer therapy due to its ability to modulate key oncogenic pathways. Its mechanisms of action include the inhibition of cyclooxygenase (COX) enzymes, which mitigates tumor-promoting inflammation and fosters a less permissive microenvironment for cancer progression. Additionally, talniflumate disrupts ionic homeostasis by targeting calcium-activated chloride channels (CaCCs), leading to impaired cellular proliferation and potential induction of apoptosis. The agent also exhibits anti-angiogenic activity by downregulating vascular endothelial growth factor (VEGF), thereby restricting tumor vascularization and growth. Furthermore, talniflumate shows potential as a chemosensitizer, enhancing the cytotoxic effects of standard chemotherapy and improving therapeutic outcomes while reducing chemoresistance. These multifaceted mechanisms highlight the therapeutic promise of talniflumate in breast cancer, warranting further preclinical and clinical studies to validate its efficacy, refine dosing strategies, and define its role in combination therapies.

PURPOSE:

To assess the therapeutic efficacy of Talniflumate in the management of breast cancer, with a focus on its synergistic interactions with neoadjuvant chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Age: ≥ 18 and ≤ 75 years, female;
* The breast cancer has been confirmed by pathological examination and Immunohistochemistry (IHC);
* Not receiving any preoperative anticancer drugs;
* The liver and kidney function satisfies the following conditions within 3 days after surgery (excluding day 3): aspartate aminotransferase (AST), glutamic-oxalacetic transaminase (ALT) \< 2 upper limit of normal (ULN), total bilirubin ≤ 1.5 ULN, serum creatinine \< 1.5 ULN;
* Other laboratory tests meet the following requirements within 3 days after surgery (excluding day 3): Hb ≥ 90g/l, platelet count ≥ 100×109/L, absolute neutrophil count \> 1.5×109/L;
* The expected survival time ≥ 6 months;
* The subjects volunteer to sign the informed consent.

Exclusion Criteria:

* Patients with stage IV breast cancer;
* Pregnant or lactating women;
* Those with active bleeding due to various reasons;
* Those with HIV infection or AIDS-associated diseases;
* Those with severe acute and chronic diseases;
* Those with severe diabetes;
* Those with serious infectious diseases;
* Those who can not take drugs by oral route;
* Drug abusers or those with psychological or mental diseases that may interfere with study compliance;
* Conditions that are considered not suitable for this study investigators
Effect Of Virtual Reality Distraction on Symptom Control and Anxiety in Children With Leukemia

This study aim to evaluate the effect of virtual reality distraction on symptom management and anxiety in children aged 7-18 years with leukemia.

While the virtual reality initiative was applied to the children in the study group, no harm was given to the children in the control group. The virtual reality distraction method will not be applied to the control group. After the child and his family are informed about the study, their written informed consent will be obtained.

When the patients were admitted to the clinic the day before chemotherapy treatment was started, the symptom screening scale and anxiety scale will be applied.

Control Group: The researcher stated that no additional procedure will be applied to the children in the control group and that the symptom screening scale and anxiety measurement will be obtained by explaining that he/she should evaluate the scale every day for 3 days.

VR group; A distraction intervention will be applied for 10-15 minutes once a day with VR glasses. The symptom screening scale and anxiety measurement will be obtained by explaining that he/she should evaluate the scale every day for 3 days.

Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients aged 7-18 years receiving leukemia treatment in the Pediatric Hematology Service
* 4 weeks after diagnosis (not in the induction phase)
* No need for blood product transfusion (less than 8 mg/dl for hematological malignancies, less than 7 mg/dl for oncological malignancies)
* Consent to voluntarily participate in the study and written consent from the child and parent

Exclusion Criteria:

* The child has a physical and psychological deficit that will prevent him from wearing glasses to watch virtual reality
* Having a symptom of nausea and vomiting
* Being in a terminal period
* Undergoing a surgical operation
* Unwillingness to participate in the study
* Having a history of vertigo (having a history of train, motion sickness)
* The child and family do not know Turkish
IB-T101 Injection for Treatment of Patients with Advanced Clear Cell Renal Cell Carcinoma

This is an open label, single center, dose escalation, and dose extension IIT study aimed at evaluating the safety, efficacy, and pharmacokinetics of IB-T101 in adult patients with advanced clear renal cell carcinoma


Eligibility Criteria:
Inclusion Criteria:

1. Voluntarily join the study, signed informed consent form， willing and able to comply with the study protocol;
2. Age ≥18 years old;
3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
4. Expected survival time of ≥ 3 months;

Exclusion Criteria:

1. CNS dysfunction with clinical significance. For example, seizures, cerebral ischemia/hemorrhage, dementia, cerebellar diseases, cerebral edema, reversible posterior encephalopathy syndrome, or any autoimmune disease involving the CNS.
2. Any form of primary and acquired immunodeficiency (such as severe combined immunodeficiency). Known human immunodeficiency virus (HIV) positive subjects
3. Have experienced myocardial infarction or unstable angina within the 6 months prior to screening
4. Pleural effusion requiring drainage for symptom management within 28 days prior to screening
Bioequivalency Study of Zaleplon 10 mg Capsules Under Fed Conditions

The objective of this study was the bioequivalence of a Roxane Laboratories' Zaleplon Capsules, 10 mg, to Sonata ® Capsules, 10 mg (Jones Pharma) under fed conditions using a single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover design


Eligibility Criteria:
Inclusion Criteria:

* No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening.

Exclusion Criteria:

* Positive test for HIV, Hepatitis B, or Hepatitis C.
* Treatment with known enzyme altering drugs.
* History of allergic or adverse response to Zaleplon or any comparable or similar product.
Cost-effectiveness of a Non-Pharmacological Treatment (Active Monitoring) vs. a Pharmacological Treatment for Major Depression in Primary Care.

Major Depression (MD) is highly prevalent and has associated a high burden and economic costs. Mild levels of MD could be treated without antidepressants at Primary Care (PC).

Main objectives: 1) To calculate the cost-effectiveness of active monitoring (recommended by NICE) vs pharmacological antidepressant treatment to treat mild MD at PC level.

Methods: 300 patients (≥18 years) with MD (diagnosed by the GP) will be recruited at the PC center. Depending on the level of symptoms, the GP will choose between: A) Active Monitoring (n=150) and B) pharmacological treatment (n=150).

Patients will be followed-up for one year and data will be collected at baseline, 6 and 12 months. Severity will be assessed by Patient Health Questionnaire (PHQ-9), quality of life with the EuroQoL-5D (5 health dimensions), and the use of services with an adapted version of the Client Service Receipt Inventory (including lost productivity).

Cost-effectiveness and cost-utility analysis will be calculated and 5000 bootstrapping replications will be conducted to asses uncertainty. Cost-acceptability curves will be done using two perspectives: the National Health Service perspective and the Societal perspective.

The Propensity Score technique will minimize the absence of randomization, matching cases from both treatment options.


Eligibility Criteria:
Inclusion Criteria:

1. Patients whose GP considers to have major depression. The indication of pharmacological or non-pharmacological treatment will be based strictly on the clinical judgment of the physician.
2. Adults (≥18 years)
3. Informed consent signed by the physician and the patient to participate in the study.

Exclusion Criteria:

1. Use of antidepressant drugs during the previous 60 days to inclusion date.
2. Alcohol or other toxic abuse.
3. Psychosis or bipolar disorder identified in the psychiatric interview
4. Use in the last 6 months of antipsychotic drugs, lithium or antiepileptic
5. Health status (pregnancy) and / or disease and / or treatments that contraindicate the use of antidepressant drugs.
6. Terminal illness.
De-identified Human Tissue Project

Research scientists of the University of Central Florida College of Medicine (COM) and Burnett School of Biomedical Sciences (BSBS) conduct laboratory studies in biomedical and translational medical research for the purpose of understanding human disease and developing innovative methods for diagnosing, measuring, or treating disease or disease symptoms. The key research divisions are cancer, cardiovascular, immunity and pathogenesis, neuroscience, and molecular microbiology.

The objective of this De-Identified Human Tissue Project is the receipt of de-identified human tissue from medical, surgical, and clinical facilities. The human tissue can be fresh or paraffinized. The human tissue will be picked up by the clinical research team and transferred to research scientists of the University of Central Florida's College of Medicine (COM) or Burnett School of Biomedical Sciences (BSBS) for storage and testing according to their separate IRB-approved or IRB-exempted protocols. These separate protocols cannot be for genetic testing. The Project does not receive human tissue resulting from termination of pregnancy.

Eligibility Criteria:
Inclusion:

- de-identified human tissue from cooperating institutions for unknown/undisclosed donors.
Microarray Analysis of microRNA Expression Profiles in Cutaneous Squamous Cell Carcinoma

MicroRNAs (miRNAs) are a novel class of short RNAs which have shown to be dysregulated in a variety of cancers. Data of miRNA expression in cutaneous squamous cell carcinoma (cSCC) is very limited and microarray based genome wide miRNA expression profiles of cSCC have not been investigated so far.

Patients with cutaneous SCC were enrolled in the present study. Tumor biopsies were taken from the center of the tumor. Adjacent healthy skin was biopsied as a control (intraindividual control). miRNA expression profiles of specimen were detected by microarray miRNA expression profiling. Microarray results were confirmed by TaqMan real-time quantitative polymerase chain reaction (RT-PCR).

Eligibility Criteria:
Inclusion Criteria:

* cutaneous squamous cell carcinoma

Exclusion Criteria:

* other skin cancer than cutaneous squamous cell carcinoma
Comprehensive Electronic Cancer Support System for the Treatment of Cancer Related Symptoms

The purpose of this study is to test the efficacy of a collaborative care intervention to manage cancer-related symptoms and improve health related quality of life in patients diagnosed with hepatobiliary carcinoma.

The study is a collaborative care intervention designed to reduce pain, fatigue, and depressive symptoms and improve overall health related quality of life.

Eligibility Criteria:
Inclusion Criteria:

* biopsy, radiological, and/or biological evidence of hepatobiliary carcinoma
* age 18 years or older
* fluency in English. Exclusion criteria included:

Exclusion Criteria:

* current suicidal or homicidal ideation
* current psychosis or thought disorder
Evaluating the Safety and Efficacy of LIPO-202 for the Reduction of Central Abdominal Bulging Due to Subcutaneous Fat (AbCONTOUR2)

This is a multi-center, randomized, double-blinded, placebo-controlled study evaluating the safety and efficacy of LIPO-202 for the reduction of central abdominal bulging due to subcutaneous fat in non-obese subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male or non-pregnant female subjects
* Capable of providing written consent.
* BMI \< 30 kg/m2
* Stable diet and exercise routine
* Central abdominal bulging that is evaluated by the clinician at least slight bulge, not flat

Exclusion Criteria:

* Have had any treatment of the fat around your abdomen, including surgical procedures (tummy tuck, liposuction), injections for fat loss or treatments with devices to reduce fat in your abdomen.
* Plan on starting a weight loss or exercise program during the study.
* Known hypersensitivity to study drugs
AMIStem-H Radiological Assessment

The purpose of this study is to evaluate radiological performance of the cementless femoral stem AMIStem H at 1 and 5-year follow-up.

All the patients operated at the investigational sites between April 2009 and April 2012 will be reviewed at 1, 5 and 10 year according to standard practice


Eligibility Criteria:
Inclusion Criteria:

* patients who underwent total hip arthroplasty at the investigational sites between April 2009 and April 2012
* patients bearing an AMIStem-H cementless femoral stem

Exclusion Criteria:

* patients who refuse to give consent for the treatment of data
Eflornithine With or Without Triamcinolone in Preventing Nonmelanoma Skin Cancer in Patients With Actinic Keratosis

RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. Eflornithine with or without triamcinolone may be effective in preventing nonmelanoma skin cancer.

PURPOSE: Randomized phase II trial to compare the effectiveness of eflornithine with or without triamcinolone in preventing nonmelanoma skin cancer in patients who have actinic keratosis.

OBJECTIVES: I. Compare the safety and efficacy of eflornithine (DFMO) vs placebo as chemoprevention of non-melanoma skin cancer in patients with moderate to heavy actinic keratosis (AK). II. Determine whether this drug reverses AK in these patients. III. Determine whether triamcinolone reduces DFMO-induced skin irritation in these patients.

OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are randomized to 1 of 4 treatment arms. Arm I: Patients receive eflornithine (DFMO) topically and triamcinolone topically to forearms once daily. Arm II: Patients receive DFMO and placebo topically as in arm I. Arm III: Patients receive placebo and triamcinolone topically as in arm I. Arm IV: Patients receive 2 placebos topically as in arm I. Treatment continues for 6 months in the absence of unacceptable toxicity. Patients are followed at 2 weeks.

PROJECTED ACCRUAL: A total of 150 patients will be accrued for this study within 1 year.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Diagnosis of actinic keratosis At least 3 clinically visible lesions on each lower posterior forearm Lesions must be discrete and quantifiable No prior or concurrent skin cancer on forearms Prior skin cancer (other than melanoma) on an area other than the forearms allowed unless chronic recurrent lesions indicate immunosuppression Concurrent skin cancer on an area other than the forearms allowed if active lesion previously excised

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No serious concurrent illness No immunosuppression due to medication or disease No invasive cancer (including melanoma) within the past 5 years Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception at least 28 days prior to and during study

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 5 years since prior systemic chemotherapy At least 6 months since prior fluorouracil (5-FU) to forearms Prior or concurrent 5-FU to the face allowed Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: See Disease Characteristics Other: At least 30 days since prior megadoses of vitamins (e.g., more than 400 IU of vitamin E, 200 micrograms of selenium, or 1 g of vitamin C per day or more than the tolerable upper limits of any other supplement) At least 6 months since prior tretinoin to forearms Prior or concurrent tretinoin to the face allowed No concurrent mega-doses of vitamins No other concurrent investigational drug or device
A Study of ARRY-614 in Patients With Low or Intermediate-1 Risk Myelodysplastic Syndrome

This is a Phase 1 study during which patients with low or intermediate-1 risk myelodysplastic syndrome (MDS) will receive investigational study drug ARRY-614.

This study has 2 parts. In the first part, patients will receive increasing doses of study drug, given either with food or without food, in order to achieve the highest dose of the study drug possible that will not cause unacceptable side effects. Approximately 60 patients from the US will be enrolled in Part 1 (Completed).

In the second part of this study, patients will receive the best dose of study drug, given either with food or without food, determined from the first part of the study and will be followed to see what side effects and effectiveness the study drug has, if any, in treating the cancer. Approximately 40 patients from the US will be enrolled in Part 2 (Completed).


Eligibility Criteria:
Key Inclusion Criteria (Part 1 and Part 2):

* Diagnosis of MDS by bone marrow biopsy.
* International Prognostic Scoring System (IPSS) score of low or intermediate-1 risk MDS.
* May have received prior therapy for MDS.
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) between 0 and 2.
* Adequate liver and renal function.
* Additional criteria exist.

Key Exclusion Criteria (Part 1 and Part 2):

* History of bone marrow transplant.
* Concomitant malignancies or previous malignancies with less than a 2-year disease-free interval at the time of enrollment.
* Treatment with an investigational medicinal product that is not expected to be cleared by the first dose of study drug or that has demonstrated to have late side effects.
* Known positive serology for the human immunodeficiency virus (HIV), hepatitis C and/or active hepatitis B.
* Additional criteria exist.
A Phase I Clinical Study of the Safety, Tolerability and Pharmacokinetics of HX-1171 in Healthy Male Subjects.

This study is designed to multiple dose and dose escalation study

A Phase I Clinical Study, Randomized, Single-blind, Placebo-controlled, Single Dose Escalation Study of the Safety, Tolerabiluty, and Pharmacokinetics of HX-1171 in Healthy Male Subjects

Eligibility Criteria:
Inclusion Criteria:

* Adult males aged 20 to 40 years at screening.
* Be able to comply with the requirement of the study. Subject must provide written informed consent prior to study participation.

Exclusion Criteria:

* History or presence of liver, kidney, or nervous system disease, respiratory disorders, endocrinological disorders, hemato-oncologic, cardiovascular or psychiatric or gastrointestinal disorders.
* History of known hypersensitivity to drugs including HX-1171.
A Safety Study of Sacubitril/Valsartan in Japanese Pediatric Patients With Heart Failure Due to Systemic Left Ventricle Systolic Dysfunction Who Have Completed CLCZ696B2319E1 Study

The purpose of this open-label study was to collect additional safety information of sacubitril/valsartan and to provide post-trial access to sacubitril/valsartan for the eligible Japanese patients who completed CLCZ696B2319E1(NCT03785405) study until marketed product of pediatric formulation, film-coated granules in capsule, is available in Japan.

This trial (CLCZ696B2319E2) was a multicenter, open-label extension study for Japanese patients who have successfully completed the CLCZ696B2319E1 study. Only Japanese patients who successfully completed CLCZ696B2319E1 study and fulfilled protocol requirements were eligible to participate in this study.

The first visit (Visit Day1) was the same day as the End of Study visit of CLCZ696B2319E1 study.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* \<18 years of age (at the time of signing informed consent)
* Completed CLCZ696B2319E1 study and safely enrolled

Exclusion Criteria:

* Permanently discontinued the study treatment during CLCZ696B2319E1 study
* Renal vascular hypertension (including renal artery stenosis)
* History of angioedema
* Having parents or legal guardians who do not give consent or allow the child to give assent, or inability of patient or the parents/legal guardians to follow instructions or comply with follow-up procedures
* Any medical condition(s) that may put the patient at risk in the Investigator's opinion or that the Investigator deems unsuitable for the study