cyrilzakka/clinical-trials huggingface dataset:
BMA and Dynamic Nomogram for Survival Prediction in Patients With CRC

This project will examine the outstanding statistical techniques for predicting the survival of patients with colorectal cancer (CRC) (colorectal neoplasia database). The motivating clinical question that led to proposing this project is based on the general assumption that: "Right-sided colorectal cancer (CRC) has worse survival than left-sided CRC." The question is, which aspects of the patient's characteristics are responsible for this difference? This led us to BMA model selection and provide a clinician-friendly online nomogram.

Translational statistics merges biostatistics and clinical research to communicate research findings effectively. Nomograms, graphical representations integrating independent prognostic factors, are valuable tools in colorectal cancer (CRC) research. Bayesian models for variable selection in survival outcome prediction offer advantages through Bayesian model averaging (BMA). This study aimed to utilise BMA for variable selection and develop a clinician-friendly online dynamic nomogram for survival prediction.

A retrospective study utilised the Cabrini Monash colorectal neoplasia database, including colon cancer patients who underwent surgery. Data on demographics, perioperative risks, treatment details, mortality, morbidity, and survival were collected. BMA was employed for Bayesian variable selection to identify effective risk factors for survival prediction. Sensitivity analyses using Cox-LASSO and imputation of missing data were performed. Prognostic online dynamic nomograms were constructed using selected risk factors and the R-package DynNom.

Eligibility Criteria:
Inclusion Criteria:

In this study, patients were included based on specific selection criteria: being 18 years old or older, having a diagnosis of colon adenocarcinoma (or post polypectomy of the same condition), and having undergone surgery for colon cancer.

Exclusion Criteria:

Patients with rectal cancer, neuroendocrine tumours, lymphomas and those who underwent trans-anal surgery were not included in the study.
A Study to Evaluate Lung Ultrasound as a Method to Measure Changes in Extravascular Lung Water Induced by Positional Changes (LUPE)

This is an exploratory study to evaluate lung ultrasound as a method for measuring extravascular lung water in stabilized patients during hospitalization for ADHF. Subjects who have been stabilized following admission for ADHF and capable of lying supine will be evaluated by lung ultrasound to determine the degree of lung congestion as measured by the total B-line score. Since different patients may require different degrees of postural change and/or other maneuvers (e.g., leg elevation or exercise) to induce B-line increments, a tailored sequential protocol will be employed to define which maneuvers are sufficient for each patient. Control patients, age-matched, will be recruited to provide a comparison group for data analysis.


Eligibility Criteria:
Inclusion Criteria:

Hospitalized for the management of acute decompensated heart failure

Reached at least a 12-hour period after hospital admission

Presence of peripheral edema with a score of at least 1+ (slight pitting in both ankles; 2mm or less depression that disappears rapidly)

Able to lie supine with no more than one pillow (approximately a 10 cm head elevation) without dyspnea for at least 30 minutes by patient report

Have not received treatment with any intravenous loop diuretic within the 4 hours prior to initiating study assessments and with no plans for additional intravenous treatment during the series of lung ultrasound measurements

Exclusion Criteria:

Persistent uncontrolled hypertension (resting systolic blood pressure \> 160 mmHg)

Significant lung disease including severe chronic obstructive pulmonary disease (See concomitant medication exclusions), pulmonary fibrosis, active asthma or acute pneumonia

Use of medications specified for the treatment of COPD including short- and long-acting bronchodilators (β-agonists and anticholinergics) and inhaled glucocorticoids as well as oxygen therapy

Use of another investigational product in a clinical study within the following time period prior to the first administration of study medication: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer)
Pediatric Supracondylar Humerus Fracture NIRS Study

The purpose of this study is to use a device to compare the blood flow in the patient's injured arm to the patient's uninjured arm. This will help us determine 'normal' readings for this device for a child's forearm and may in the future help us detect children that have injured the blood vessels that go to the forearm when they have an elbow fracture. The patient will be one of approximately 100 people involved in this research project at Carolinas Medical Center, and the patient's participation will last until the patient is discharged from the hospital. It is hypothesized that if the blood vessel is uninjured, the readings on the NIRS device on the injured arm will be equal to the uninjured arm. It is also hypothesized that if the blood vessel of the injured arm is injured, the readings on the NIRS device will be different than on the uninjured arm.

Supracondylar humerus fractures (fracture just above the elbow) are common in children. Supracondylar humerus fractures account for 60% of the elbow fractures in children. Some supracondylar fractures injure the brachial artery and a small percentage of children present with an absent radial pulse after supracondylar humerus fracture, and these injuries may result in insufficient blood flow to the ipsilateral forearm. This can lead to compartment syndrome and/or ischemic contracture of the forearm muscles, and may result in permanent disability. Currently, physicians do not have objective data to determine whether or not the forearm muscles below a supracondylar humerus fracture are receiving adequate blood flow and must rely on the clinical exam of the wrist and hand distally. The purpose of this study is to use near infrared spectroscopy (NIRS) to compare the blood flow in the forearm muscle compartments of an injured arm compared to an uninjured arm. This will provide data to establish normal readings for this device for a child's forearm, and may then help clinicians detect children with insufficient perfusion of the forearm muscles after supracondylar humerus fracture.

Eligibility Criteria:
Inclusion Criteria:

* supracondylar humerus fracture needing operative treatment
* ages 2-17

Exclusion Criteria:

* Bilateral (both sides) arm injuries
* Other injuries to the same arm
* Open fractures
* Previous vascular (blood vessels) injury to the upper extremity (arm)
* Vascular disease or insufficiency
* Not willing to consent to participate
* Only having one arm
Renal Impairment Study of Empagliflozin (BI10773) in Japanese Patients With Type 2 Diabetes

The objective of this study is to assess the effect of the different degrees of renal impairment on the pharmacokinetics, pharmacodynamics and safety of BI10773 following oral administration of high dose BI10773 as a single dose in Japanese patients with type 2 diabetes mellitus.


Eligibility Criteria:
Inclusion criteria:

* Type 2 diabetes patients
* Glycosylated haemoglobin\>= 6.1% (Japan Diabetes Society)
* Estimated glomerular filtration rate based on the modification of diet in renal disease-formula at screening , of \>= 15 mL/min/1.73m2

Exclusion criteria:

* Any evidence of significant disease (other than renal impairment)
* Moderate and severe concurrent liver function impairment
* Gastrointestinal tract surgery, that might affect absorption and elimination of drugs
* Diseases of the central nervous system (such as epilepsy), psychiatric disorders, or neurological disorders
* Chronic or relevant acute infections
* Participation in another trial with investigational drug administration within 30 days prior to study drug administration or during the trial
Counselling Intervention for College Students Experienced Psychological Distress

The goal of this clinical trial is to evaluate mental health and academic motivation in university students asking help to university counselling service (UCS) in Southern Italy before anf after four weekly psychological sessions.

The main question it aims to answer are:

* is the psychological counselling intervention useful in improving psychological distress and academic motivation
* which psychological variables predict the intervention outcome

The participants will be university students who completed psychological counselling intervention delivered by UCS (University of Campania, Italy). They will be asked to completed an internet-based survey, administered anonymously through Google Forms. The survey consist of two sections. The first section includes questions about sociodemographic characteristics (e.g., gender and age), enrollment year, type of university course attended, academic standing (i.e., whether all exams within the prescribed period had been passed), and previous or current contact with psychological or psychiatric mental health services (university or non-university). The second section comprises four scales that assessed the variables of interest.

To measure psychological distress and problems, the Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) will be used. Feelings of loneliness will be assessed using the University of California-Los Angeles Loneliness Scale version 3 (UCLA-LS3). Emotion regulation will be assessed using the Difficulty in Emotion Regulation Scale (DERS). Students intentions to continue or to drop out of the academic course will be measured with self-reported questions.

Eligibility Criteria:
Inclusion Criteria:

* being university students who asked psychological help to university counselling service and completed the intervention

Exclusion Criteria:

* do not speak Italian
A Study of Rofecoxib in the Treatment of Post-Operative Pain After Total Knee Joint Replacement (0966-259)

A study to compare pre-operative administration of rofecoxib versus post-operative administration of diclofenac or rofecoxib, respectively, in the treatment of post-operative pain after total knee joint replacement in patients with osteoarthritis of the knee.


Eligibility Criteria:
Inclusion Criteria:

* Males or females at least 18 years of age who have osteoarthritis of the knee and have undergone total knee joint replacement.
AQUABEAM India Study for the Treatment of Benign Prostatic Hyperplasia

Single-arm prospective, interventional clinical trial. Results will be compared to a historical control in the treatment of benign prostatic hyperplasia


Eligibility Criteria:
Inclusion Criteria:

* Male
* 50 - 80 years
* Moderate to severe BPH
* Subjects who have failed standard medical therapy

Exclusion Criteria:

* Size and width of prostate
* Medical condition or co-morbidities where BPH intervention would be contraindicated
Healthy Immigrant Community: Mobilizing the Power of Social Networks

The objective of this study is to leverage existing social networks for health behavior change relevant to obesity and cardiovascular risk among immigrant populations in Southeast, Minnesota.


Eligibility Criteria:
Inclusion Criteria:

* Self-identification as Hispanic or Somali.
* Member of a social network identified in the social network analysis.
* Willingness to participate in all aspects of the study.
* Provision of informed consent.

Exclusion Criteria:

* Pregnancy at the time of enrollment.
* Serious medical conditions or disabilities that would make physical activity difficult.
* To avoid stigmatization, a normal weight (BMI\<25) will not exclude individuals from participating in the intervention, but they will be excluded from the measurements and analyses.
Impact of Lower Body Weight Support Treadmill on Cardiopulmonary Exercise Capacity and Trainability

The AlterG®-anti-gravity treadmill provides lower body weight support which enables individuals to exercise without feeling their full body weight. How this body weight support influences cardiovascular, respiratory, vascular and metabolic parameters is currently unclear. Further, whether body weight support influences the trainability in response to moderate continuous exercise is unknown. This investigation has two main goals. First, we explore the direct influence of lower body weight support on cardiometabolic parameters during maximal exercise testing. Second, we aim to compare changes in cardiorespiratory fitness in response to a structured exercise protocol using moderate intensity with and without lower body weight support.


Eligibility Criteria:
Inclusion Criteria:

* maximal oxygen consumption below age-sex specific standard

Exclusion Criteria:

* acute infection within the last four weeks
* anemia (males: Hb \< 8.1 mmol/L; females Hb \< 7.4 mmol/L)
* previous reports of myo-, endo, or pericarditis
* previous stroke or acute myocardial infarction
* heart failure (NYHA \> 1)
* aortic valve stenosis
* congenital heart disease
* cardiomyopathy
* severe left ventricular hypertrophy
* cardiac arrythmias
* hypertension
* diabetes
* BMI \> 35
* cancer
* pregnancy
* aneurysm of aorta or cerebral arteries
Cardiac Disease and the Electrocardiogram in SCI Patients

The purpose of this three-year study is to determine the prevalence and incidence of the different types of cardiac disease and ECG abnormalities in SCI patients. Study goals are: (i) delineation of the specific types of heart disease that occur in the SCI population as manifested both pre-clinically and clinically and (ii) demonstration of their association with ECG findings. This will enable validation of scores and algorithms using the inexpensive and widely available ECG for the prevention of heart disease as well as it's early treatment and rehabilitation in SCI patients.

The findings will be helpful in demonstrating what cardiological tests are appropriate for the mandated annual evaluation of SCI patients.

The purpose of this three-year study is to determine the prevalence and incidence of the different types of cardiac disease and ECG abnormalities in SCI patients seen at the PAVA SCIC and their association. Study goals include: i) delineation of the specific types of heart disease that occur in the SCI population as manifested both pre-clinically and clinically and ii) demonstration of their association with ECG findings. This will enable validation of scores and algorithms using the inexpensive and widely available ECG for the prevention of heart disease as well as it's early treatment and rehabilitation in SCI patients. Our findings will be helpful in demonstrating what cardiological tests are appropriate for the mandated annual evaluation of SCI patients.

There are two components to this study:

An outcomes component to complete information previously gathered in clinical and computerized databases of 800 SCI patients and a convenience sample of age-matched able-bodied veterans and perform a follow up for cardiac events.

A screening component to identify pre-clinical disease will include Holter ECG recordings and echocardiograms on patients without symptoms or evidence for heart disease seen in the SCI center during the course of the study and age-matched able-bodied veterans.

Hypothesis (a): The prevalence and incidence of cardiac diseases including coronary artery disease and cardiomyopathy will be higher in the SCI population than age-matched samples of the able-bodied population while valvular disease and arrhythmia will be similar. (b): The prevalence and incidence of cardiac disease in SCI individuals will be associated with level and completeness of injury (ie, higher occurrence in those with higher lesion levels and more complete injuries.) (c) The ECG will be helpful in SCI patients in early identification and secondary prevention of both ischemic and cardiomyopathic heart disease. (d) Continuous Holter ECG recordings or echocardiograms will only be indicated for screening specific SCI patients identified by clinical and electrocardiographic features.

Eligibility Criteria:
SCI patients
Efficacy Study of Escitalopram for Depression in Patients With Diabetes

Patients with diabetes and major depression treated with Escitalopram might experience significant improvement in depression and anxiety scores; functional ability; diabetes-related self-care; and pain symptoms

Major depression is common in patients diabetes (point prevalence about 15-20%). It has been shown that patients with diabetic and major depression experience more severe diabetes symptoms, greater disability, more frequent medical complications, greater healthcare utilization costs, poorer glycemic control, and greater difficulties with diabetes self-care activities, compared with patients with diabetes without depression. Few specific features of Escitalopram, a selective serotonin reuptake inhibitor (SSRI), make it a promising medication for use in diabetes. These include a benign side effect profile; high tolerance in elderly patients; rapid action with efficacy often demonstrated in as little 1-2 weeks, which in turn could help improve compliance; its efficacy for treatment of generalized anxiety disorder, which may also be relatively common in patients with diabetes, and co-occurs frequently with depression. This study is designed to test the efficacy of Escitalopram for the treatment of major depression in patients with diabetes mellitus.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older.
* Diagnosis of Type-1 or Type-2 diabetes mellitus (excluding gestational diabetes) by a specialist at least 6 months prior to the study.
* Current diagnosis of major depression based on DSM-IV criteria .
* Hamilton Depression Rating Scale (HAMD) baseline score \> 17
* Available for 14-weeks of treatment and all evaluations.
* Able to understand study rules and procedures and willing to sign written informed consent for study participation.

Exclusion Criteria:

* Competence: Not competent to understand and sign informed consent forms and/or to understand and answer the evaluations.
* Psychiatric exclusions: One or more of the following: Alcohol or substance abuse or dependence in past 6 months; psychotic symptoms or history of psychosis; bipolar disorder; organic brain syndrome; significant suicide risk; homicidal thoughts.
* Medical exclusions: Known intolerance or hypersensitivity to escitalopram or other SSRI; pregnancy; breastfeeding; women of childbearing potential not using adequate contraception; significant renal or hepatic dysfunction (such that demands medical workup and/or regular follow up); resting heart rate less than 40/minute (or 50/minute if symptomatic); uncontrolled hypertension (systolic blood pressure \>180 mm Hg or diastolic blood pressure \>100 mm Hg); any acute or unstable medical condition that might interfere with the safe conduct of the study.
* Concomitant medication(s) exclusion: Current use (within 2 weeks of enrollment) of one or more of the following: antidepressants; regular benzodiazepine; neuroleptics; anticonvulsants; reserpine; guanethidine; clonidine; methyldopa.
Collecting Medical Information and Tissue Samples from Patients with Pancreatic Cancer or Other Pancreatic Disorders

RATIONALE: Gathering medical information and collecting and storing samples of blood and tissue to test in the laboratory may help doctors develop better ways to screen people at risk for pancreatic cancer or other pancreatic disorders in the future.

PURPOSE: This clinical trial is collecting medical information and tissue samples from patients with pancreatic cancer or other pancreatic disorders.

PRIMARY OBJECTIVE:

I. To maintain a resource (bank) of biospecimens and data collected from individuals being seen clinically for pancreas conditions to facilitate the discovery and development of (but not limited to) biomarkers of risk (including genomic and proteomic) and early detection as well as novel targeted therapies for pancreatic diseases with a focus on pancreatic cancer.

OUTLINE: This is an observational study.

Patients undergo blood, saliva, and previously obtained leftover tissue sample collection on study. Patients also complete questionnaires and have their medical records reviewed on study.

Eligibility Criteria:
* Known or suspected pancreas disease including:

  * pancreas adenocarcinoma
  * islet cell cancer
  * pancreatic cysts
  * pancreatitis (hereditary, acute, or chronic)
* Next of kin of deceased participant who did not complete participation before passing away

Exclusion Criteria:

* Under the age of 18
* Unable to provide informed consent
* Prison inmates
A Clinical Study of Light Therapy on Depressive Episodes of Bipolar Disorder

The purpose of this study is to investigate the efficacy and safety of light-emitting diode(LED) light therapy on Chinese patients with Depressive Episodes of Bipolar Disorder and to gather prime research data and application parameters of LED light source which is not currently available in China.


Eligibility Criteria:
Inclusion Criteria:

* ages 18 to 65 years
* comply with the DSM-IV diagnosis of Bipolar I or II Disorder and a current depressive episode
* HAMD score ≥17 points
* intake of just one particular psychotropic drug(a mood stabilizer or an atypical antipsychotic drug) except of antidepressants and lasted 2 weeks.

Exclusion Criteria:

* inability to provide informed consent;
* previous treatment with BLT
* presence of another major psychiatric illness such as schizophrenia, schizoaffective disorder, lifetime alcohol or substance dependence
* diagnosed with a rapid-cycling bipolar disorder or currently in the mixed state or YMRS score\>12 points
* use of antidepressants medications
* significant medical illness such as diabetes mellitus,heart failure, renal failure, severe liver function abnormalities,hyperthyroidism or hypothyroidism
* pregnancy;
* received magnified electroconvulsive therapy orRepetitive Transcranial Magnetic Stimulation in the past 3 months
* an eye condition that could be negatively affected by bright light
* suicidal risk or other factor making trial participation clinically inappropriate.
Brain Imaging in the Idiopathic REM Sleep Behavior Disorder (ALICE)

Idiopathic rapid eye movement sleep behavior disorder (iRBD) is characterized by nocturnal violence, increased muscle tone during REM sleep and the lack of any other neurological disease. However, iRBD can precede parkinsonism and dementia by several years. The causes of the loss of muscle atonia during REM sleep in these patients are unclear. Using 3 T MRI and neuromelanin- sensitive sequences, the signal intensity was previously found to be reduce in the locus coeruleus/subcoeruleus area of patients with Parkinson's disease and RBD. Here, the investigators aimed at studying the integrity of the locus coeruleus/ subcoeruleus complex with neuromelanin-sensitive imaging in 21 patients with iRBD and compared the results with those from 21 age- and gender-matched healthy volunteers. All subjects will undergo a clinical examination, motor, cognitive, autonomous, psychological, olfactory and color vision tests, and rapid eye movement sleep characterization using video-polysomnography and 3 T magnetic resonance imaging.


Eligibility Criteria:
Inclusion Criteria:

- idiopathic RBD (criteria of the international classification of sleep disorders-3)

For healthy controls : no neurologic or psychiatric disorder

Exclusion Criteria:

* Contraindication to MRI
* Do not speak French