cyrilzakka/clinical-trials huggingface dataset:
Artificial Intelligence System for Assessment of Tumor Risk and Diagnosis and Treatment

To improve the accuracy of risk prediction, screening and treatment outcome of cancer, we aim to establish a medical database that includes standardized and structured clinical diagnosis and treatment information, image features, pathological features, and multi-omics information and to develop a multi-modal data fusion-based technology system using artificial intelligence technology based on database.

The main aims are as follows:

1. To establish a data platform for multi-modal information of common tumors (lung cancer/pulmonary nodules, stomach and colorectal cancers) : electronic medical records (including routine clinical detection, treatment, outcome), pathological image data, medical imaging (CT, MRI, ultrasound, nuclear medicine, etc.), multiple omics data (genome, transcriptome, and metabolome, proteomics) omics data, etiology and carcinogenic exposure information.
2. We will make use of artificial intelligence technology to create the multi-modal medical big data cross-analysis technology and the above disease individualized accurate diagnosis and curative effect prediction models. In order to solve the three key problems of multi-modal data fusion mining, such as unbalanced, small sample size, and poor interpretability, we will establish an artificial intelligence recognition algorithm for image images and pathological images, and use image processing and deep learning technologies to mine multi-level depth visual features of image data and pathological data. In addition, we will use bioinformatics analysis algorithms to conduct molecular network mining and functional analysis of molecular markers at the level of multiple omics technologies (pathologic, genomic, transcriptome, metabolome, proteome, etc.).

Eligibility Criteria:
Inclusion Criteria:

1. Participants with the suspected of lung cancer/node, or stomach cancer/lesion, or colorectal cancer/leision
2. Participants that have signed informed consent.
3. Participants with detailed electronic medical records, image records, pathological records, multi-omics information, and other important clinical diagnostic information.
4. Healthy participants with no clinical diagnosis of lung cancer/node, or stomach cancer/lesion, or colorectal cancer/leision.

Exclusion Criteria:

1. Participants with primary clinical and pathological data missing.
2. Participants lost to follow-up.
3. Participants with too poor medical image quality to perform segment and mark ROI accurately
Pain Mechanisms in Patients With Bronchiectasis

Pain mechanisms and their clinical impact in patients with bronchiectasis have not been investigated yet. The aim of the research is to assess the presence of central pain mechanisms in patients with bronchiectasis using the Quantitative Sensory Testing (QST) assumptions.

Background and objective:

Recent findings suggest that pain can play an important role in terms of physical activity limitation in respiratory patients. Nevertheless, pain mechanisms and their clinical impact in patients with bronchiectasis have not been investigated yet. The objective of the observational study is to determine the somatosensorial profile in order to assess the presence of central pain mechanisms in patients with bronchiectasis.

Methodology:

Repeated-measures prospective cross-sectional study. A sample of patients diagnosed with bronchiectasis will be recruited and matched by age and sex with healthy controls. Pressure pain thresholds (PPTs), conditioned pain modulation (CPM) and referral pain will be assessed before and after the Incremental Shuttle Walking test (ISW). Levels of physical activity will be assessed using accelerometry during a 7-days period. Sleep quality (Pittsburgh sleep quality test), level of catastrophizing (Pain Catastrophizing Scale), level of sensitization (Central Sensitization Inventory) and level of anxiety and depression (Hospital Anxiety and Depression) will be assessed. The assessments will be done twice: 1) at baseline; and 2) at 6 months follow-up period.

Eligibility Criteria:
Bronchiectasis Group

Inclusion Criteria:

* Diagnosis of bronchiectasis by high-resolution computed tomography.
* Ability to understand and perform all the clinical procedure.
* Acquisition of informed consent.

Exclusion Criteria:

* Diagnosis or clinical suspicion of cystic fibrosis by genetic test or sweat electrolytes test.
* Diagnosis of rheumatic disease.
* Being on a waiting list for lung transplantation.
* Thoraco-abdominal surgery in the last 6 months.
* Chronic use of pain medication.

Control Group

Inclusion Criteria:

* Healthy subjects matched by age and sex with Bronchiectasis Group's subjects

Exclusion Criteria:

* Be taking pain medication.
* Presence of pain condition or pathology.
Extracorporeal Shockwave on Abdominal Adiposity and Lipid Profile

Almost postmenopausal women store significant extra visceral adipose tissue with unexplained mechanism, yet. Postmenopausal obese women with excess abdominal obesity have raised metabolic risk of numerous cardiovascular diseases, which negatively influence health policy concern. Therefore, actual need to recommend non-invasive approach that cover this lack of quantitative knowledge in clinical management of obese postmenopausal women.

Postmenopausal women are usually troubled by increasing weight and waist circumference caused by obesity and androcidal fat redistribution. Abdominal adiposity, defined as a waist circumference ≥88cm in women, measured in the upright position, plus significant elevated lipid profile values. In postmenopausal women, a higher level of physical activity was associated with a more optimal body composition, including lower adiposity and higher lean mass. Management of abdominal obesity involves different techniques i.e., dietary management, exercise therapy, even lifestyle management, and pharmacological management, and surgical interventions. Extracorporeal shockwave provides cavitation phenomena that may facilitate better management of abdominal obesity. Thus, current study will be conducted to investigate effect of extracorporeal shockwave on abdominal adiposity and lipid profile in obese post-menopausal women.

Eligibility Criteria:
Inclusion Criteria:

* Their age range 45-60 years old.
* Their body mass index range 30-35 kg/m square.
* Only, obese postmenopausal women with at least one year after stoppage of menses.

Exclusion Criteria:

* Receiving pharmacological treatment.
* Receiving any form of electrotherapy.
* Whom with metabolic, hematological or renal dysfunction.
* Whom have dermatological or cardiovascular or respiratory, digestive or rheumatic disorders.
Predictive Model of Recovery in Patients With Chronic Nonspecific Neck Pain Undergoing Manual Therapy and Exercise

The aim of this study is to develop a predictive model to identify which patients with chronic nonspecific neck pain are more likely to benefit from manual therapy and exercise program, or usual care.


Eligibility Criteria:
Inclusion Criteria:

* Chronic nonspecific neck pain at least 3 months, defined as pain in the cervical region without a specific anatomopathological diagnosis;
* Adults between 18 and 65 years of age and literate in Portuguese;

Exclusion Criteria:

* History of cervical trauma and/or history of surgery in the prior 6 months;
* Clinical signs of infection, tumor, neurological, inflammatory or systemic diseases;
* Pregnancy
Multiple Dose Escalation Trial Of PF-04308515 In Healthy Volunteers

The purpose of this study is to determine the safety, tolerability, pharmacokinetics and pharmacodynamics (how the drug effects certain target sites of activity in the body) of escalating doses of oral PF-04308515 in healthy volunteers for 14 days as well as one oral dose of a tablet formulation administered for 1 day.


Eligibility Criteria:
Inclusion Criteria:

* Healthy males between 18 and 55 years, inclusive
* Healthy females between 18 and 44 years, inclusive
* Females are required to be surgically sterile

Exclusion Criteria:

* Evidence or history of clinically significant disease
* Post-menopausal women
* History of intolerance or significant adverse effects with glucocorticoid therapy
Study to Investigate Luveltamab Tazevibulin in Adults with Advanced or Metastatic Non-small Cell Lung Cancer

A Phase 2 study evaluating STRO-002 in subjects with previously treated advanced or metastatic non-small cell lung cancer expressing FOLR1

This is a multicenter, open-label study. The study is designed to assess the preliminary efficacy and safety of luveltamab tazevibulin, an anti-FOLR1 antibody drug conjugate (ADC) in previously treated subjects with advanced or metastatic NSCLC that expresses FOLR1.

Subjects will receive luveltamab tazevibulin administered intravenously every 3 weeks until disease progression, intolerable toxicity, elective withdrawal from the study, or study termination.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed non-squamous/adenocarcinoma or adenosquamous NSCLC that is either unresectable Stage IIIb/c disease not amenable for definitive chemoradiation, or Stage IV.
* Age ≥ 18 years
* ECOG performance status 0 to 1.
* Received at least 2 but no more than 4 prior lines of systemic therapy for advanced NSCLC
* Disease progression during or following the most recent systemic anti-cancer therapy.
* Positive FOLR1 expression per central testing
* At least 1 measurable target lesion per RECIST 1.1
* Adequate organ function

Exclusion Criteria:

* Prior treatment with a FOLR1- targeting ADCs or with ADCs that contain a tubulin inhibitor
* Untreated central nervous system metastases
* Ongoing immunosuppressive therapy, except for treated brain metastases, per criterion above.
* History of severe allergic or anaphylactic reactions to monoclonal antibody therapy or to antibody-related fusion protein treatment
* Pre-existing clinically significant ocular disorders, severe chronic obstructive pulmonary disease or asthma, clinically significant cardiac or cerebrovascular disease, or other significant concurrent, uncontrolled medical condition
* Previous solid organ transplantation
* Concurrent participation in another therapeutic treatment trial
Feasibility of an App-based Nutrition & Exercise Program in Cirrhosis

The personalized nutrition and exercise app was designed for use by individuals living with chronic conditions. The pilot study examines the acceptance and use of the online, interactive program to support self-management in cirrhosis.

Patients living with chronic disease are at-risk for frailty because of their potentially sedentary lifestyle and/or symptoms. Supervised exercise programs are useful for improving or maintaining physical capacity as measured by common physical function measures. However, accessibility is limited due to scheduling, transportation, employment, and residential location. Unsupervised, self-directed home-based programs have had limited success due to absence of peer support and accountability.

An alternative is an app-based program that offers interactive engagement with study staff and accountability. Further, follow-along videos and tracking for both nutrition and exercise can be completed at the patient's convenience.

A 12-week pilot study with patients living with cirrhosis will assess the acceptability of the programming. The hypothesis is that study participants will find the customization of the app and interaction with the study staff acceptable as measured by completion rates (primary study endpoint). Secondary outcomes include change in measures (0-12 weeks) for the 6-minute walk test (6MWT), thigh muscle thickness, and chair sit-to-stands. At the end of the study, participants will also complete a program satisfaction survey (developed in-house).

Interviews with participants, caregivers, and study staff, conducted via videoconference at 4-6 weeks and end of study, will be descriptively analysed to identify feasibility, acceptability, and perceived utility of the program. Analyses will also identify areas for program improvement.

Eligibility Criteria:
Inclusion Criteria:

* adult (aged 18 years and older)
* diagnosis of cirrhosis (MELD\<25) according to biopsy, imaging, elastography, or other
* fulfill the guideline-based prophylaxis in place for high risk gastroesophageal varices
* able to communicate (e.g., speak, read, and write) in English
* provide informed written consent for self

Exclusion Criteria:

* hepatocellular carcinoma (HCC) outside of the Edmonton liver transplant criteria
* previous myocardial infarction
* EF \<50%
* ischemia on stress testing
* oxygen saturation \<95%
* non-HCC malignancy
* end-stage renal disease.
* at the discretion of the healthcare team if a participant can participate in the pilot study
Multiple Ascending Dose Study of BMS-929075 in Hepatitis C Virus (HCV) Infected Patients

The purpose of this study is to determine the change from baseline in HCV Ribonucleic acid (RNA) on Day 4 following three days of dosing with BMS-929075 in chronically genotype subtype 1a and 1b HCV infected subjects


Eligibility Criteria:
Inclusion Criteria:

* Men and women, ages 18 to 65 years, inclusive
* Subjects who are naive to HCV treatment, defined as no previous exposure to an Interferon (IFN), Ribavirin (RBV); or any HCV-specific direct acting antiviral or experimental therapy
* HCV genotype 1a or 1b only
* HCV RNA viral load of ≥ 100,000 IU/mL
* Have one of the following: i) Documented Fibrotest score of ≤ 0.72 and AST to platelet ratio index (APRI) ≤ 2; or ii) Documented liver biopsy within 12 months preceding Day 1 showing absence of cirrhosis
* Body Mass Index (BMI) of 18.0 to 35.0 kg/m2, inclusive

Exclusion Criteria:

* Any significant acute or chronic medical illness
* History of adrenal gland disease, including but not limited to adrenal insufficiency or Cushing's syndrome
* Current or recent (within 3 months of study drug administration) gastrointestinal disease
* Any major surgery within 4 weeks of study drug administration
* Any gastrointestinal surgery that could impact upon the absorption of study drug
* Positive for hepatitis B surface antigen (HBsAg)
* Positive for Human Immunodeficiency Virus (HIV) -1 and/or -2 antibodies
* Smoking \> 10 cigarettes per day
* Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) \> 5x upper limit of normal (ULN)
* Total Bilirubin ≥ 1.5x ULN
* Hemoglobin \< 10 g/dL
* Platelets \< 75,000 cell/μL
* ALC (absolute lymphocyte count) \< 1000 cell/μL
* Creatinine clearance (as estimated by method of Cockcroft and Gault) less than 60 mL/min
Buprenorphine Stabilization and Induction Onto Vivitrol for Heroin-dependent Individuals

A short-term treatment with buprenorphine prior to initiating treatment with naltrexone may increase the proportion of heroin-dependent patients successfully inducted onto Vivitrol.


Eligibility Criteria:
Inclusion Criteria:

1. Individuals between the ages of 18-60
2. Meets DSM-5 criteria of current opioid use disorder with six consecutive months of reported heroin use, supported by a positive urine for opiates indicating regular use of heroin
3. Seeking treatment for opioid use disorder with Vivitrol
4. Capable of giving informed consent and complying with study procedures
5. In otherwise good health based on complete medical history and physical examination, laboratory tests, and EKG
6. BMI between 18-40

Exclusion Criteria:

1. Reported treatment with methadone in the last 3 months or positive urine toxicology for methadone on the day of consent
2. Maintenance on, or regular use of buprenorphine or other prescription opioids
3. Pregnancy, lactation, or failure in a sexually active woman to use adequate contraceptive methods.
4. Active medical illness which might make participation hazardous, such as untreated hypertension, acute hepatitis with AST or ALT \> 3 times normal, AIDS (CD4 count under 200 currently or medically ill with an opportunistic infection), unstable diabetes, cardiovascular disease.
5. Active psychiatric disorder which might interfere with participation or make participation hazardous, including DSM-5 Schizophrenia or any psychotic disorder, severe Major Depressive Disorder, or suicide risk or 1 or more suicide attempts within the past year.
6. Physiologically dependent on alcohol or sedative- hypnotics with impending withdrawal. Other substance use diagnoses are not exclusionary.
7. History of allergic or adverse reaction to buprenorphine, naltrexone, naloxone, clonidine, or clonazepam.
8. Chronic neurocognitive disorder
9. History of accidental drug overdose in the last 3 years as defined as an episode of opioid-induced unconsciousness or incapacitation, whether or not medical treatment was sought or received.
10. Painful medical condition that requires ongoing opioid analgesia or anticipated surgery necessitating opioid medications
11. Fentanyl only use, supported by a urine toxicology that is positive for fentanyl only and negative for all other opioids.
12. Court mandated to treatment
Deep vs Moderate Neuromuscular Blocks on Remifentanil for Laparoscopic Gastrectomy

The primary purpose is to compare the remifentanil requirements in deep vs moderate neuromuscular blocks during the surgical pleth index -guided anesthesia in patients undergoing laparoscopic gastrectomy.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of gastric cancer Scheduled laparoscopic gastrectomy

Exclusion Criteria:

* Patients refusal to consent Hyperbilirubinemia Chronic pain Opioid abuse Incurrent infective status Peripheral vascular disease
Phase III Randomized, Double-Blind, Placebo-Controlled Study of Dehydroepiandrosterone in Women With Active Systemic Lupus Erythematosus

OBJECTIVES:

I. Evaluate the safety and efficacy of synthetic dehydroepiandrosterone, GL701, in women with active systemic lupus erythematosus.

PROTOCOL OUTLINE: This is a randomized study. Patients are stratified by participating institution.

Patients are randomly assigned to daily oral dehydroepiandrosterone or placebo for 52 weeks. Patients are evaluated every 13 weeks on study and return for a follow-up 6 weeks after completion of therapy.

Concurrent therapy with estrogen replacement and stable doses of prednisone, azathioprine, methotrexate (with folate supplementation), hydroxychloroquine, and nonsteroidal anti-inflammatory drugs is allowed. Other investigational medications and immunosuppressants are prohibited.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Systemic lupus erythematosus by 1982 American College of Rheumatology criteria Diagnosed for at least 6 months

Systemic Lupus Activity Measure score at least 7 Points for erythrocyte sedimentation rate excluded

SLEDAI score of greater than 2 at both screening and qualifying visits

--Prior/Concurrent Therapy--

No prior participation in any dehydroepiandrosterone (DHEA) study

No investigational agent within the longer of 30 days or 10 half-lives of the agent

Prednisone (or equivalent) dose 0 to 10 mg/day Unchanged for at least 6 weeks prior to entry

At least 3 months since immunosuppressants other than azathioprine and methotrexate, including:

* DHEA
* Adrenocorticotropin hormone
* Androgens
* Cyclophosphamide
* Cyclosporine
* Immune globulin

At least 6 weeks since change in azathioprine, methotrexate, or hydroxychloroquine

--Patient Characteristics-- Renal: No requirement for hemodialysis

Cardiovascular: No serious abnormality on electrocardiogram

Other:

* No hypersensitivity to DHEA or inactive ingredients in GL701 formulation, i.e., cornstarch, lactose, or magnesium stearate
* No history of breast cancer or reproductive tract malignancy
* Cervical carcinoma eligible if surgically cured, i.e., no evidence of disease for 5 years
* No condition that would prevent compliance or follow-up, e.g.: Alcoholism Drug addiction Acute withdrawal from chemical dependency
* Psychiatric disease
* No pregnant or nursing women
* Negative pregnancy test required of fertile women
* Reliable contraception required of fertile women
* No estrogen-containing oral contraceptives on study
* At least 3 weeks since estrogen-containing oral contraceptives
Trend in Hospital Lengths of Stay and Readmissions

Medical and surgical innovations have allowed to shorter length of hospital stay (LOS). We assume that hospitals with uncontrolled reduction in LOS may expose patients to unsafe care. At the institutional level, a dynamic analysis of LOS evolution over time could clarify the existence of a link with the risk of readmission.


Eligibility Criteria:
Inclusion Criteria:

* All patients who underwent elective colorectal surgery or urgent surgical procedure for hip fracture in French public and private hospitals from January 2014 to December 2016

Exclusion Criteria:

* Age \< 18 years old
* Death during the index stay
Endovascular Denervation in Patients With Cancer Pain

Endovascular arterial denervation (ED) is a minimally invasive technique which could reduce the occurrence of injury of visceral tissue or organs. As the principle of renal denervation (RDN), Radiofrequency energy delivered by a multi-electrode catheter to the celiac plexus over the anterolateral surface of the superior mesenteric artery (SMA) and the celiac axis. Damaged or partially damaged celiac plexus can achieve the effect of pain relief.

The multi-electrode catheter was consisted of six independent electrodes helically on a net structure, which could be set as the same energy and temperature for simultaneous multi-point ablation. A real-time monitoring capability also provided by the display.

Eligibility Criteria:
Inclusion Criteria:

* 25 to 75 years
* severe cancer pain with the visual analogue scores of no less than 7

Exclusion Criteria:

* pregnant or intent to become pregnant within 1 year
* postural hypotension
* uncorrected coagulation dysfunction
* aortic aneurysm or dissection
* type 1 diabetes mellitus (T1DM)
* acute or severe systemic infection
* history of cerebral apoplexy or transient ischemic attack (TIA) in the past two weeks
* history of acute coronary syndrome in the past two weeks
* participants who are not suitable to be enrolled into the study assessed by the researchers
Comparison of Preoperative Ultrasound Guided Pectoralis Nerve Block Placement Versus Intra-operative Placement: A Prospective Randomized Trial

This study investigates the use of post-operative on-Q pain catheters for tissue expander based breast reconstruction, versus conventional ultrasound-guided blocks placed pre-operatively.


Eligibility Criteria:
Inclusion Criteria:

* presenting for breast reconstruction w/ planned two-stage, sub muscular tissue expander placement.

Exclusion Criteria:

* pregnant, prisoners, cannot consent, history of chronic pain or pain medication use
Registry for Accelerated Partial Breast Irradiation With (SBRT) or (IMRT)

This is a registry study that will be used to evaluate external beam radiation therapy methods for the accelerated treatment of breast cancer. Patients are being asked to take part in this registry because they have breast cancer and desire treatment with accelerated partial breast irradiation to be delivered by external beam methods.


Eligibility Criteria:
Inclusion Criteria:

* Greater than or equal to 50 years old Low to intermediate DCIS Tumor size \< or = to 2cm

Exclusion Criteria:

* BRCA positive Lobular histology Angiolymphatic invasion