cyrilzakka/clinical-trials huggingface dataset:
Surgery Versus Internal Radiation in Treating Patients With Stage II Prostate Cancer

RATIONALE: Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells. It is not yet known whether surgery is more effective than internal radiation in treating prostate cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of surgery with that of internal radiation in treating patients who have stage II prostate cancer.

OBJECTIVES:

* Compare overall survival in patients with stage II prostate cancer treated with radical prostatectomy vs brachytherapy.
* Compare metastasis-free survival and probability of survival without symptoms of patients treated with these regimens.
* Compare the side effects of these treatment regimens in these patients.

OUTLINE: This is a randomized study. Patients are randomized to one of two treatment arms.

* Arm I: Patients undergo radical prostatectomy.
* Arm II: Patients undergo brachytherapy with implanted iodine I 125 or palladium Pd 103 seeds Patients are followed every 6 months for 5 years and then annually thereafter.

PROJECTED ACCRUAL: A total of 1,980 patients (990 per treatment arm) will be accrued for this study within 5.5 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed adenocarcinoma of the prostate within the past 120 days

  * T1c-T2a, N0, M0
* No bilateral disease
* Prostate-specific antigen (PSA) no greater than 10 ng/mL

  * In patients with prior neoadjuvant hormonal therapy (NHT), PSA must be less than 10 ng/mL prior to therapy
* Gleason score no greater than 6
* Prostate gland less than 60 cc on transrectal ultrasound or with minimal pubic arch interference OR
* Prostate gland 60 cc or greater prior to NHT allowed if prostate size has been reduced to less than 60 cc by NHT

PATIENT CHARACTERISTICS:

Age:

* 75 and under

Performance status:

* ECOG 0-2 OR
* Zubrod 0-2

Renal:

* Creatinine no greater than 3 mg/dL

Cardiovascular:

* No significant cardiovascular disease
* No New York Heart Association class III or IV heart disease

Other:

* No other malignancy within the past 5 years except effectively treated basal cell or squamous cell skin cancer or other malignancy at low risk for recurrence
* No other condition that would preclude study

PRIOR CONCURRENT THERAPY:

Endocrine therapy:

* See Disease Characteristics
* At least 90 days since prior NHT

  * Duration of therapy no greater than 120 days
* No concurrent NHT

Radiotherapy:

* No prior radiotherapy to pelvis

Surgery:

* No prior surgery for prostate cancer or benign disease, including:

  * Transurethral resection of the prostate
  * Transurethral resection of the bladder neck
  * Cryotherapy
  * Laser ablation
  * Microwave therapy
Intensive Education in Increasing Understanding of Lymphedema in Patients With Breast Cancer Undergoing Surgery

This pilot clinical trial studies intensive education in increasing understanding of lymphedema in patients with breast cancer undergoing surgery. Lymphedema is the build-up of fluids in the arm (or other extremity) after surgery. Providing written educational handouts and verbal education on the risk factors and symptoms of lymphedema may improve patients' ability to identify symptoms of lymphedema after surgery.

PRIMARY OBJECTIVES:

I. To assess the patient's increased knowledge of lymphedema signs/symptoms after education.

SECONDARY OBJECTIVES:

I. The participant may detect lymphedema signs/symptoms at an early stage by having a pre-surgery comparison of bilateral upper extremities (BUE) circumferential measures to the 3 month post-surgery measures.

OUTLINE:

Participants complete a five question survey, designed by the Occupational Therapy staff, as an instrument to assess a patient's knowledge of lymphedema signs/symptoms before surgery. An Occupational Therapist (OT), Physical Therapist (PT), and/or Certified Lymphedema Therapist (CLT) provide written handouts to participants on the pathophysiology, signs, symptoms, and treatment of lymphedema. Participants repeat the survey at 3 months post-surgery. BUE circumferential measurements are also collected before surgery and at 3 months post-surgery.

Eligibility Criteria:
Inclusion Criteria:

* Participants will be diagnosed with breast cancer; the participants will be scheduled for a lumpectomy or a mastectomy at UH GMC Seidman Cancer Center
* They must understand written, verbal, and/or recorded survey questioning English

Exclusion Criteria:

* Individuals with previous radiation treatments to the breast or axilla areas
* Prior diagnosis of lymphedema
* Persons that do not speak English
* Those unwilling to participate in the follow-up call 3 months post-surgery
Postoperative Fatigue and Nausea Related to Choice of Anaesthetic Regimens

The purpose of this study is to establish validated outcome measures for Postoperative Fatigue and Postoperative nausea, and to compare clinical impact of postanaesthetic symptoms during first week after Propofol or Desflurane based anaesthesia.


Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for day-surgery laparoscopic cholecystectomy
* The patient is able to read and comprehend Norwegian language
* The patient is cognitive adequate and able to fill in survey forms
* The patient has read and signed patient information form

Exclusion Criteria:

* Serious illness (ASA 3-4)
* Pregnancy or suspected pregnancy
* Breastfeeding women
* Contraindications to use of NSAIDs
* Serious allergic reaction to anaesthetics
* Allergy towards egg, soya or peanuts
* Known or suspected Malignant Hyperthermia or Porphyria
* Fatigue-related diagnosis
* Recently received adjuvant therapy (chemotherapy, radiotherapy)
* Severe chronic pain
Ublituximab in Combination With TGR-1202 +/- Ibrutinib or Bendamustine in Patients With B-cell Malignancies

The purpose of this study is to evaluate the safety and effectiveness of Ublituximab in combination with TGR-1202, with or without ibrutinib or bendamustine, in patients with advanced hematologic malignancies


Eligibility Criteria:
Inclusion Criteria:

* Confirmed B-cell non-Hodgkin lymphoma (NHL), chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), and other B-cell lymphoproliferative disorders as approved by the Medical Monitor or Study Chair
* Refractory to or relapsed after at least 1 prior treatment regimen
* Eastern Cooperative Oncology Group (ECOG) score of 0 to 2

Exclusion Criteria:

* Any major surgery, chemotherapy or immunotherapy within the last 21 days
* Known hepatitis B virus, hepatitis C virus or HIV infection
* Autologous hematologic stem cell transplant within 3 months of study entry or Allogeneic hematologic stem cell transplant within 12 months
* Primary central nervous system lymphoma or known intracranial involvement
Suprapubic Versus Transurethral Catheterization After Rectal Resection With Low Anastomosis for Cancer in Males

The purpose of this study is to compare the urinary tract infection rate on the four postoperative day between the 2 groups of patients who have undergone total mesorectal excision for cancer and low anastomosis, with either suprapubic or transurethral catheterization.


Eligibility Criteria:
Inclusion Criteria:

* Male patients of at least 18 years of age
* Histologically proven rectal adenocarcinoma
* Stage T1-4 Nx Mx
* With or without neoadjuvant treatment
* TME and low anastomosis (colorectal or coloanal, stapled or handsewn)
* With or without loop ileostomy
* Open or laparoscopic approach
* Patient and doctor have signed a study specific informed consent form

Exclusion Criteria:

* Colonic and upper third rectal cancer (No or Partial Mesorectal Excision)
* Abdominoperineal resection
* Associated prostate, and/or seminal glands and/or bladder resection
* Infected tumour, Emergency surgery
* Epidural analgesia
* Patient with antibiotic therapy (other than prophylaxis)
* Previous treated/untreated known prostate or bladder carcinoma
* Patient with symptomatic preoperative voiding dysfunction (IPSS score \>19)
* Medical history of bladder catheterization for obstruction, or urethral surgery
* Patient necessitating urinary output monitoring (impaired renal function etc)
* Patient deprived of liberty or under guardianship or incapable of giving consent
* Against the usual indications of suprapubic drainage and / or urethral sounding any known allergies to medical device materials. (p. ex. latex) and in general the known allergies to sterilizing agents (particularly oxide ethylene and its derivatives.
Safety and Tolerability of OXC XR as Adjunctive Therapy in Subjects With Refractory Partial Epilepsy

Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of Oxcarbazepine Extended-Release (OXC XR)

NAP

Eligibility Criteria:
Inclusion Criteria

1. Able to provide written informed consent and agree to comply with study procedures.
2. Male or female aged 18 to 66 years, inclusive.
3. Successful completion of the 804P301 study.
4. Sexually active women, unless surgically sterile (at least 6 months prior to Study Medication \[SM\] administration) or at least 1 year post-menopausal, must use an effective method of avoiding pregnancy (including oral, transdermal, or implanted contraceptives \[any hormonal method in conjunction with a secondary method\], intrauterine device, female condom with spermicide, diaphragm with spermicide, cervical cap, abstinence, use of condom with spermicide by sexual partner or sterile \[at least 6 months prior to SM administration\] sexual partner) for at least four weeks prior to SM administration, and must agree to continue using such precautions through the End of Study visit. Cessation of birth control after this point should be discussed with a responsible physician.

Exclusion Criteria

1. Clinically significant change in health status that, in the opinion of the Investigator, would prevent the subject from participating in this study or successfully completing this study.
2. Any reason which, in the opinion of the Investigator, would prevent the subject from participating in the study.
Relation Between AI-QCA and Cardiac PET

The aim of the study is to evaluate the clinical implications of artificial Intelligence (AI)-assisted quantitative coronary angiography (QCA) and positron emission tomography (PET)-derived myocardial blood flow in clinically indicated patients.

Percutaneous coronary angiography (CAG) is a standard method for evaluating coronary artery disease. Traditionally, a reduction in the luminal diameter of the coronary arteries by 50% or more during angiography has been considered a significant stenotic lesion. However, the assessment of coronary artery stenosis is usually based on visual estimation by the operator in daily routine clinical practice, which interferes with the objective evaluation.

Quantitative coronary angiography (QCA) has been developed to overcome this limitation. This technique involves the software-based analysis of coronary images obtained through CAG. The previous study showed that there was low concordance between the QCA and visual estimation of coronary artery stenosis (Kappa=0.63) and a reclassification rate of approximately 20%. Furthermore, visual assessments tended to overestimate the degree of coronary artery stenosis, particularly in complex lesions such as bifurcation lesions.

However, there are some limitations to adopting QCA in our daily routine practice. The QCA cannot analyze coronary images on-site and is not fully automated, requiring manual adjustments by humans. Recent advancements have led to the development of artificial intelligence (AI)-based QCA software, which achieves complete automation in the analysis process and provides real-time objective evaluations of coronary artery stenosis.

This study aims to examine the clinical significance of AI-QCA by assessing the correlation between the degree of coronary stenosis detected by AI-QCA and myocardial blood flow abnormalities observed in 13NH3-Ammonia PET scans in patients with coronary artery disease.

Eligibility Criteria:
Inclusion criteria

1. Subject must be ≥18 years
2. Patients suspected with CAD or ischemic heart disease
3. Patients undergoing CAG and cardiac PET for evaluation of severity of coronary artery disease

Exclusion criteria

1. Poor imaging quality of CAG and PET which were not available for core-lab analysis
2. Chronic total occlusion
3. Time interval was more than \>3 months between CAG and PET
4. History of coronary artery bypass grafting
5. History of acute myocardial infarction or recent myocardial infarction
6. Heart failure (left ventricular ejection fraction \<40%)
Evaluation of Cognitive State Using Neurosteer EEG System

This is an observational study. Patients who fulfill all inclusion criteria and none of the exclusion criteria will be enrolled in the study, be neurologically evaluated and will go through EEG recordings while listening to an auditory cognitive assessment tool and preforming tasks. EEG recordings will be analyzed using proprietary computational analyses.

One of the major problems in the prevention and treatment of neurological disorders, is the lack of cost effective and reliable tools to assess neurodegeneration on a large scale at a very early stage. Although current imaging methods give a clear image of the brain atrophy involved in neurodegenerative disorders, there are deficiencies prohibiting their usage for prevention-scanning of large high-risk population such as high price, long set-up time and the need for trained personnel to conduct the test. An objective tool to asses the level of cognitive decline is therefore needed. Such a tool may be used to determine the level of cognitive decline independent of personal interpretation and/or variance between clinicians and provide consistency in assessment across patients and between medical facilities.

The Neurosteer system provides objective neurological biomarkers using a wearable easy-to-use affordable system. The system facilitate the capture and interpretation of EEG data with only a single patch of electrodes, attached on the subject's forehead. Neurosteer examination includes completing auditory tasks while measuring brain activity with the device. The data is analyzed using machine learning methods to produce biomarkers, enabling a report of the patient's activity in real time and offline. The examination is easy to preform and can be conducted in every clinic or in patients' homes.

In this study, clinical staff will identify potential subjects and will examine the eligibility of subject according to inclusion and exclusion criteria. Patients (or legal guardian) will sign the Informed Consent Form (ICF). Research staff will set up an assessment session using Neurosteer system. In this session the patient will listen to the auditory assessment battery and perform tasks. Level of cognition will be assessed by Neurosteer technology and statistical analysis will be performed to validate the results.

Eligibility Criteria:
Inclusion Criteria:

* Men and women over the age of 45.
* MMSE score \< 30.
* MMSE score ≥ 10.
* Patient is able to collaborate.
* No other cognitive comorbidity.
* No seizure event.

Exclusion Criteria:

* Advanced stage of cognitive decline (MMSE \< 10).
* Any verbal or non-verbal form of objection from patient or form patient's family member or significant other.
* Presence of several cognitive comorbidity.
* Damage to integrity of scalp and/or skull.
* Skin irritation in the facial and forehead area.
* Significant hearing impairments.
* History of drug abuse.
Effects of Chocolate on Coronary Vasomotion in Patients After Heart Transplantation

The aim of the present study is to investigate whether the ingestion of a flavonoid-rich dark chocolate compared to flavonoid-free placebo chocolate will improve coronary vasomotion in heart transplanted patients.

Dark chocolate contains a high amount of flavonoids. Flavonoids hold the possibilities to improve oxidative stress and hence the possibility to improve endothelium-dependent coronary vasomotion, which is a powerful surrogate for clinical prognosis. Coronary atherosclerosis is promoted by impaired endothelial function and increased platelet activation. High oxidative stress and reduced antioxidant defenses play a crucial role in the pathogenesis of atherosclerosis, in particular in transplanted hearts. The aim of the present study is to investigate whether the ingestion of a flavonoid-rich dark chocolate compared to flavonoid-free placebo chocolate will improve coronary vasomotion in heart transplanted patients.

Eligibility Criteria:
Inclusion Criteria:

1. Patients after heart transplantation not requiring immediate coronary intervention
2. Age 20 - 80
3. Written obtained informed consent

Exclusion Criteria:

1. Heart failure (acute or chronic \>NYHA II)
2. Ventricular tachy-arrythmias or AV-Block \>I°
3. Renal insufficiency (\>200 μmol/l) or liver disease (ALT or AST \>150 IU)
4. Symptomatic hypotension, hypertension \>160/100mmHg
5. Known allergy to compounds dark chocolate
6. Acute infectious disease
7. Disease with systemic inflammation (e.g. rheumatoid arthritis, M. Crohn)
8. Participation in another study within the last month
9. Concomitant vitamin supplements
Clinical Validation of the Prognostic Value of the PrTS on Prostate Cancer Patients

Prostate Cancer is the most common type of cancer among men in many countries. However current clinical tools have limited prediction accuracy to choose the optimal treatment for the individual patient, as prostate cancer risk assessment is a critical aspect of treatment decision-making. A substantial proportion of patients are undergoing over-treatment such as radical treatment, which is often associated with negative physical and psychological side effects, dramatically affecting quality of life in a negative way. Moreover, the patients that are under-treated will face higher cancer mortality risks, which brings more concerns for patients and doctors. Prostatype composes a one-step 4-plex quantitative reverse transcription polymerase chain reaction kit, a database based on authenic patients information and a score system (P-score), intended to measure gene expression levels of three biomarkers: IGFBP3, F3 and VGLL3. Genetic values combined with clinical parameters in the CPMA and P-score are aiming to estimate the aggressiveness of prostate tumor for a newly diagnosed prostate cancer patient. This is a single-center, retrospective, blinded validation study aim to investigate the prognostic performance of the Prostatype test system.


Eligibility Criteria:
Inclusion Criteria:

* Non-metastatic prostate adenocarcinoma confirmed by histopathology after taking core needle biopsy
* Regular visits, treatment and laboratory tests were conducted in the past
* There is biopsy materials at the time of diagnosis (without staining FFPE)
* The total area of tumor tissue shall be 25-30 mm2, and the proportion of tumor cells after tumor cell enrichment is at least 50%
* Complete records of relevant clinical follow-up information

Exclusion Criteria:

* Biopsy tissue is not available, or FFPE does not meet the screening requirements of study samples
* Relevent clinical parameters of the patients are not available
* Treatment methods are not available
* Age of diagnosis \< 50 years
* Age of diagnosis \> 100 years
* Total tumor length \< 2 mm
* The patient died of an accident, homicide or suicide
Performance Evaluation of an Advanced Algorithm With CGM in Adults, Adolescents, and Pediatrics

The purpose of this study is to demonstrate the performance of the Guardian™ Sensor (3) with an advanced algorithm in subjects age 2 - 80 years, for the span of 170 hours (7 days).

The study is a multi-center, prospective, single-sample correlational design without controls. The purpose of this study is to demonstrate the performance of the Guardian™ Sensor (3) with an advanced algorithm in subjects age 2 - 80 years, for the span of 170 hours (7 days).

Eligibility Criteria:
Inclusion Criteria:

1. Individual is 2 - 80 years of age at time of enrollment
2. A clinical diagnosis of type 1 or 2 diabetes for a minimum of 6 months duration as determined via medical record or source documentation by an individual qualified to make a medical diagnosis
3. Adequate venous access as assessed by investigator or appropriate staff
4. Subjects participating in the high and low glucose challenges must have an insulin carbohydrate ratio(s) and insulin sensitivity ratio. Subjects without ratios may participate under observation only

Exclusion Criteria:

1. Subject will not tolerate tape adhesive in the area of Guardian™ Sensor (3) placement as assessed by a qualified individual.
2. Subject has any unresolved adverse skin condition in the area of sensor or device placement (e.g., psoriasis, rash, Staphylococcus infection)
3. Subject is actively participating in an investigational study (drug or device) wherein they have received treatment from an investigational study (drug or device) in the last 2 weeks
4. Subject is female and has a positive pregnancy screening test
5. Female of child bearing age and who is sexually active should be excluded if she is not using a form of contraception deemed reliable by investigator
6. Subject is female and plans to become pregnant during the course of the study
7. Subject has had a hypoglycemic seizure within the past 6 months prior to enrollment
8. Subject has had hypoglycemia resulting in loss of consciousness within the past 6 months prior to enrollment.
9. Subject has had an episode of diabetic ketoacidosis (DKA) within the past 6 months prior to enrollment.
10. Subject has a history of a seizure disorder
11. Subject has central nervous system or cardiac disorder resulting in syncope
12. Subject has a history of myocardial infarction, unstable angina, coronary artery bypass surgery, coronary artery stenting, transient ischemic attack (TIA), cerebrovascular accident (CVA), angina, congestive heart failure, ventricular rhythm disturbances or thromboembolic disease
13. Subject has a hematocrit (Hct) lower than the normal reference range (please note that patients may use prior blood draw from routine care as long as done within 6 months of screening and report of lab placed with subject source documents)
14. Subject has a history of adrenal insufficiency
15. Subject is a member of the research staff involved with the study.
Long-term Evaluation of Patients Treated by an Emergency Medical Helicopter

In May 2010 the first danish physician-staffed Helicopter Emergency Medical Service (PS-HEMS) was implemented in Region Zealand and the Capital Region (excluding Bornholm) of Denmark.

In relation to the introduction of PS-HEMS, a team of collaborators lead by Rasmus Hesselfeldt, conducted an observational study to investigate the possible effects on time to definitive care, secondary transfers and 30-day mortality in a "before" and "after" design.

Results showed reduced time from first dispatch to arrival at the trauma centre from 218 min to 90 min. Secondary transfers to the trauma centre dropped from 50 % to 34 % and 30-day mortality significantly reduced from 29 % to 14 % in the year after implementation.

The present study is an observational cohort study with long-term follow-up of the same trauma population as mentioned above. Patients were followed until may 1st, 2014.

Primary outcome is early retirement and secondary outcomes are quality of life and mortality.

The investigators hypothesize that a greater proportion of trauma patients in the "after" period will remain in occupation after approx. 3 to 4.5 years compared with trauma patients treated in the "before" period.


Eligibility Criteria:
Inclusion Criteria:

* Patients treated by a trauma team in the catchment area of PS-HEMS.

For all labor market attachment analysis the investigators only include patients between 18 to 60 years of age. For all other analysis (mortality and quality of life) there are no age limits.

Exclusion Criteria:

* Patients transported by private means or by the police.
* Patients who at the emergency department were categorized as non-trauma patients.