cyrilzakka/clinical-trials huggingface dataset:
ColoCare Study - Colorectal Cancer Cohort

ColoCare is an international prospective cohort study of stage I-IV colorectal cancer patients (ICD-10 C18-C20).

The ColoCare Study is a multicenter initiative establishing an international cohort of colorectal cancer (CRC) patients for interdisciplinary studies of CRC prognosis and outcomes with sites at the Fred Hutchinson Cancer Center, Seattle (Washington, USA), H. Lee Moffitt Cancer Center and Research Institute, Tampa (Florida, USA), the University Hospital Heidelberg (Germany), the Huntsman Cancer Institute (Utah, USA), the Cedars-Senai Medical Center (California, USA), University of Washington St. Louis (Missouri, USA), and University of Tennessee (Tennessee, USA).

Aims: The ColoCare Study investigates clinical outcomes, including disease-free and overall survival, predictors of cancer recurrence, survival, health-related quality-of-life and treatment toxicities. In addition, cross-sectional analyses of biomarkers and/or health behaviors are undertaken. Patients will be recruited if their age range is 18-89 years. For patients recruited after 09/01/2021 the age range is between 18-69 years, except if they participate in specific sub-studies or in studies for older cancer patients. Recruitment of patients \>70 years was re-initiated after 06/2024 in anticipation of R01 grant funding.

Patients are recruited at baseline (time of first diagnosis) and followed for up to 5 years at regular timepoints (3m, 6m, 12m, 24m, 36m, 48m, 60m). The cohort includes a comprehensive collection of specimens and data. For the U01 renewal phase (start September 2021) we specifically focus on the recruitment of minorities (early-onset patients, African American patients, Hispanic patients) and patients with rectal cancer. Furthermore, we will have an overall focus on questionnaire assessment at baseline, 12, and 60 months and intensive medical chart abstraction 24 months and 60. months after enrollment into the study.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18-89 years; for patients recruited after 09/01/2021 the age range is 18-69 years. Recruitment of patients 70 years and older was maintained for specific sub-studies and re-initiated for specific R01 grant funding in \~06/2024
2. Men and women
3. Newly-diagnosed colon or rectal cancer (stages I-IV); CRC in treatment (FHCRC and HCI)
4. English (FHCRC, Moffitt, HCI, Cedars-Sinai, WashU St. Louis) or German (University Hospital Heidelberg)-speaking;
5. mentally/physically able to consent and participate.

Exclusion Criteria:

* if one of the above in not fulfilled
* insufficient language or consent capacity
Cost-effectiveness of Extracorporeal Life Support Treatment

This study evaluates patients on ECLS treatment as considered appropriate with mortality and health related Quality of life and costs.

A direct comparison between usual care and ECLS treatment is difficult. Alternatively we compare predicted mortality for every patient based on validated scoring systems at the initiation of ECLS treatment with the actual outcome, so every patient is his own control.

Primary outcome is HRQoL assessed with the EQ-5D questionnaire at 1 year. Healthcare costs and costs from a societal perspective are prospectively measured.

Eligibility Criteria:
Inclusion Criteria:

* Admitted to intensive care
* Treated with extracorporeal life support

Exclusion Criteria:

* none
Cost of Monitoring Patients Treated With Vitamin K Antagonists in Spain

To estimate annualized total cost rates (i.e. direct medical costs from hospitalizations, consultations, medications, and tests) of adequately controlling a patient (i.e. INR between 2-3 and TTR≥ 60%) diagnosed with non-valvular atrial fibrillation (NVAF) or venous thromboembolism (VTE), and treated with vitamin K antagonists (VKA) in Spain.


Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Patients aged 18 or older over the study period
* Patients with a diagnosis for NVAF or VTE anytime in their medical records
* Patients having at least one year of enrolment in the database prior to the index date
* Patients newly initiated with VKA during the study period (index date)

Exclusion Criteria:

* Patients with a diagnosis for both NVAF and VTE anytime in their medical records
Feasibility Study: Self-guided iCBT for Mothers With Postpartum Depression.

The purpose of this study is to conduct a feasibility study to test the study procedure and a newly developed self-guided internet-based cognitive behavioral therapy program for mothers with postpartum depression.

The aim of the feasibility study is twofold: 1) to test the feasibility of the study, and 2) to test the acceptability of the internet-based cognitive behavioral therapy program and to minimize dropout.

The study will be conducted as a mixed-method process evaluation. Twenty mothers will be included in the study. After being informed about the study and its potential, all patients who give written informed consent will be randomized in a 1:1 ratio into either the control group, receiving treatment as usual, or the intervention group, receiving treatment as usual plus the iCBT program iCARE. The intervention period will last for two months.

After the intervention period, investigators will use a survey distributed from REDCap to measure its feasibility, participants' satisfaction with it, and acceptability.

After the two-month intervention period, semi-structured interviews will be conducted with participants from both the intervention and control groups to gather qualitative insights. This feasibility study will also provide a preliminary evaluation of the intervention's impact. The findings from this pilot study will inform the design of the subsequent randomized controlled trial (RCT) and guide any necessary modifications to the treatment program and associated procedures.

Eligibility Criteria:
Inclusion Criteria:

* Edinburgh Postnatal Depression Scale (EPDS) score 11-18
* ≥age 18
* Access to the internet

Exclusion Criteria:

* Thoughts of self-harm≥2 on EPDS item 10
* Do not understand Danish language,
* Substance abuse or dependence
* Alcohol abuse, defined as a weekly consumption of alcohol exceeding ten units,
* Physical condition requiring frequent hospitalization like dialysis, chemotherapy, or blood transfusion,
* A diagnosis of schizophrenia or other psychotic disorders.
The Effect of Naltrexone and Varenicline on Alcohol-Mediated Smoking Lapse

The purpose of this study is to examine how medications thought to attenuate the effects of alcohol (naltrexone) and smoking cessation medications (varenicline) affect the ability to resist smoking and also subsequent ad-lib smoking, following a low-dose alcohol priming drink, in non-treatment seeking alcohol-drinking daily smokers.


Eligibility Criteria:
Inclusion Criteria:

* ages 21-55
* ability to read and write in English
* alcohol-drinking smokers

Exclusion Criteria:

* any significant current medical conditions that would contraindicate smoking
* current DSM-IV abuse or dependence of other substances, other than nicotine dependence or alcohol abuse.
* positive test result at intake appointments on urine drug screens conducted for opiates, cocaine, or benzodiazepines
* women who are pregnant or nursing
* suicidal, homicidal or evidence of current severe mental illness
* participants prescribed any psychotropic drug in the 30 days prior to study enrollment
* blood donation within the past 6 weeks
* individuals seeking treatment for smoking cessation or drinking or have attempted to quit smoking or drinking within the past 3 months
* specific exclusion for administration of naltrexone not specified above including chronic pain conditions necessitating opioid treatment, and evidence of significant hepatocellular injury as evidenced by SGOT or SGPT \> 3x normal or elevated bilirubin
* known allergy to varenicline or taking H2blockers (e.g., Cimetidine)
* participation within the past 8 weeks in other studies that involve additive blood sampling and/or interventional measures that would be considered excessive in combination with the current protocol
Effects of tDCS on Heart Rate Variability in Chronic Low Back Pain

Chronic low back (CLBP) pain is an important public health and socioeconomic problem worldwide and, despite the volume of research in the area, it remains a difficult condition to treat. There are some evidences that altered heart rate variability (HRV) parameters are associated with different clinical disorders, such as chronic low back pain. For instances, diminished parasympathetic activity has been explored as a potential therapeutic target. Considering the dynamic interaction between brain and heart, neuromodulatory strategies targeting this relationship could exert a positive influence on cardiac autonomic system and pain modulation systems.

Transcranial direct current (tDCS) stimulation is a noninvasive neuromodulation technique that has been presenting recent advances in the treatment of chronic pain. However, tDCS application focusing on brain-heart interaction has not been extensively explored, especially on chronic pain conditions.

This study aims to investigate the effects of tDCS on HRV in chronic low back pain patients. Sixty patients will be randomized into two distinct groups to receive either tDCS (anodal) or tDCS (sham) in a single session protocol. The primary clinical outcome (HRV parameter) will be collected before, during and post-tDCS. The data will be collected by a blind examiner to the treatment allocation.


Eligibility Criteria:
Inclusion Criteria:

* Complaining of back pain for more than three months.
* Presence of a chronic pain measurable with the number rating scale (NRS 0-10) not less than 4 during a 1 week daily NRS monitoring.
* Seeking care for low back pain.

Exclusion Criteria:

* Previous surgery on the spine
* Spondylolisthesis
* Previous treatment with tDCS
* Disc herniation with nerve compression Neurological
* Psychiatric
* Rheumatologic diseases
* Impaired sensibility
* Use of pacemakers or other implanted devices
* Pregnancy
* Cardiovascular diseases
Blood Volume and Hemodynamic Analysis in Patients With Chronic Heart Failure

The primary hypothesis is that patients with HFREF (heart failure with reduced ejection fraction) will demonstrate a markedly expanded intravascular volume which will correlate with elevated right heart hemodynamics and increased venous capacitance parameters, whereas patients with HFPEF(heart failure with preserved ejection fraction) will demonstrate euvolemia to mild volume expansion and a lack of correlation with hemodynamic and venous compliance parameters.

The purpose of this study is to learn more about how the heart, blood vessels and blood volume interact in patients with heart failure and how measuring blood volume and vein capacity may help us develop better ways of treating and managing heart failure patients. This study will use two tests to measure blood volume and test the capacity of your veins and arteries in your limbs.

The blood volume test (also called a plasma volume test or a red cell mass test) is a standard clinical nuclear lab procedure used to measure the volume (amount) of blood in the body. The test also measures the volume of plasma and of red cells in the blood.

The other test is called a venous plethysmography, which is a non-invasive test to measure how well your veins and arteries in your forearm and calf work. Venous plethysmography measures the changes in the dimensions of your limbs by the use of strain gauges placed on the skin.

Eligibility Criteria:
Inclusion Criteria:

* age \>18 years
* patients identified with heart failure and diagnosed clinically to require right heart hemodynamic evaluation, New York Heart Association functional Class II-IV status/Stage C-D heart failure
* ischemic or nonischemic etiology heart failure
* left ventricular ejection fraction measured within 6 months of study enrollment

Exclusion Criteria:

* known significant intrinsic chronic kidney disease (baseline Glomerular Filtration Rate \<15 ml/min/1.73m²) or patients receiving hemodialysis
* known renal artery stenotic disease
* females who are pregnant
* allergy to iodine contrast, intravenous pyelogram dye, shellfish or eggs.
Effectiveness and Safety Trial of a New Ischemic Stroke Treatment Within 24 Hours From Stroke Onset (NEST-2)

The purpose of this pivotal study is to demonstrate safety and effectiveness of the NeuroThera® Laser System (referred to hereafter as NTS) in the treatment of Subjects diagnosed with acute ischemic stroke. The initiation of NTS treatment must be feasible for each Subject within 24 hours of stroke onset.

This study is a prospective, double blind, randomized, sham controlled, parallel group, multi-center study that will include enrollment of up to 660 Subjects. Subjects will be followed for 90 days post stroke onset. The primary effectiveness endpoint for this study will be the binary endpoint that defines success as a modified Rankin Scale (mRS) score of 0-2 and failure as an mRS score of 3-6 at 90 days or the last rating. The secondary effectiveness endpoint for this study will be the change in NIHSS score from baseline to 90 days or the last rating, analyzed across the full range of scores on the NIHSS. Tertiary effectiveness endpoints include: The 90-day binary endpoint, denoted as the 90-day bNIH score, based on the NIHSS score that defines a successful result as either (i) an improvement of 9 or more points on the NIHSS or (ii) a final NIHSS score of 0 or 1; the score on the mRS at 90 days or the last rating analyzed across the range of scores from 0 to 6 on the mRS scale, SIS-16 at 90 days; mortality at 30, 60 and 90 days.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of Acute Ischemic Stroke within 24 hours
2. Clinical diagnosis of Acute Ischemic Stroke after exclusion of hemorrhage by a CT scan or susceptibility weighted MRI sequences
3. NIHSS ≥7 - ≤22

Exclusion Criteria:

1. \>24hours from symptom onset to time of treatment
2. Evidence of intracranial, subdural, or subarachnoid hemorrhage
3. Clinical presentation of intracranial hemorrhage
4. Pre stroke ≥3 mRS
5. The presence of a brainstem or cerebellar stroke
6. Transient Ischemic Attack (TIA)
7. Seizure at stroke onset
8. Blood glucose \>400 or \<60
9. Sustained systolic BP \>220mmHG \< 80mmHG or diastolic \>140mmHG \<50mmHG
10. Septic embolus
11. CNS tumor (except asymptomatic meningioma)
12. Dermatologic condition of the scalp (e.g. Psoriasis)
13. Thrombolytic therapy
14. Head implant (e.g. Clipped aneurysm, Hakim valve)
Pharmacodynamic and Pharmacokinetic Study of PL-ASA

A randomized, open-label, 2-way crossover pharmacodynamic and pharmacokinetic study of a novel pharmaceutical lipid-aspirin complex formulation (PL-ASA) at an 81 mg dose

This study is a randomized, open-label, 2-way crossover study to assess pharmacodyamic and pharmacokinetic profiles following treatment with PL-ASA and EC-ASA administered under fasting condition at a single dose of 81 mg among the volunteers aged 50 to 75 years.

Eligibility Criteria:
Inclusion Criteria:

* Male or female non-smoking subjects between the ages of 18 to 75 years inclusive, without known medical conditions requiring treatment
* Consumes on average no more than 2 alcoholic drinks per day for 30 days prior to study

Exclusion Criteria:

* Abnormal baseline laboratory results
* Current prescribed use of aspirin, warfarin or other anticoagulants
* Use of other specific medications within 2 weeks of study start
* History of certain medical conditions
* Subject's platelets are unresponsive to arachidonic acid, as defined as \<60% of aggregation as measured by light transmittance aggregometry
Trivalent Chromium Treatment for Rheumatoid Arthritis

Trivalent chromium has shown good results in abolishing inflammation and had a successful result in treating animal model of rheumatoid arthritis. In addition to that, trivalent chromium lacks many side effects which are related to the already known medications of the disease.

So this study aims to evaluate the efficacy of trivalent chromium supplementation in rheumatoid arthritis treatment and measuring the outcomes of that in rheumatoid arthritis patients.

Rheumatoid arthritis is a debilitating autoimmune disease which is treated by medications that have many side effects. Trivalent chromium, a naturally occurring element with regulatory effects on blood sugar, has shown anti-inflammatory properties in many studies and has shown a good response at alleviation of rheumatoid arthritis in the disease animal model. For these reasons trivalent chromium should be tried in rheumatoid arthritis patients.

Eligibility Criteria:
Inclusion Criteria:

* rheumatoid arthritis

Exclusion Criteria:

* other autoimmune diseases
Anterior Cruciate Ligament (ACL) Reconstruction: Single Bundle Versus Double Bundle

ACL tear is a common injury among athletes. The recommended treatment includes reconstruction of the ligament. The common reconstruction technique is single bundle reconstruction. However, this technique does not simulate the natural structure of the ligament. The purpose of the study is to compare between the common procedure, Single Bundle reconstruction with the Double Bundle reconstruction technique.


Eligibility Criteria:
Inclusion Criteria:

* knee instability with a history of ACL tear
* diagnosed ACL tear according to MRI
* age range 16-40.

Exclusion Criteria:

* previous surgery in the knees
* multiple ligament raptures
* partial ACL tear
* severe cartilage degeneration
* genovaruse/genovalgus
* thin hamstrings tendons
* oper epiphysis in the knee joint
* patient with muscle/neurological problem that increases the tendency to fall
DCE-MRI Guided Neoadjuvant Chemotherapy for Borderline Resectable Pancreatic Cancer

The goal of this study is to test whether chemotherapy guided by a new imaging method named DCE-MRI can more effectively reduce a pancreatic tumor, enabling curable surgery, over the conventional method when a tumor is categorized as borderline resectable pancreatic cancer. UAB radiological research team has been studying a cutting-edge imaging technique named dynamic contrast-enhanced magnetic resonance imaging, or DCE-MRI, for over 10 years. This technique has been globally used to calculate the blood flow of various tissues, including tumors. Blood flow often serves as a critical indicator showing a disease status. For example, a pancreatic tumor typically has low blood flow, so it can be used as an indicator to identify the presence of a pancreatic tumor. In addition, an effective therapy can result in the increase of blood flow in a pancreatic tumor during the early period of treatment. Therefore, the investigators may be able to determine whether the undergoing therapy is effective or not by measuring the change of blood flow in the pancreatic tumor and deciding whether to continue the therapy or try a different one.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (age 19 years or older).
* Patients with newly diagnosed and untreated borderline resectable pancreatic cancer.
* Patients with signed informed consent.

Exclusion Criteria:

* Any history of prior radiation or chemotherapy or surgical removal for pancreatic cancer.
* Participants with safety contraindications to MRI examination (determined by standard clinical screening).
* Participants who are pregnant, lactating or are planning to become pregnant during the study.
* Participants who are planning to father a child during the study.
An Observational Study of Epoetin Beta [Neorecormon] to Evaluate the Quality of Life in Patients on Dialysis With Chronic Renal Anemia

This multicenter, prospective, observational study will evaluate the quality of life and the factors that influence the quality of life of epoetin beta \[Neorecormon\] in patients with renal chronic anemia, who are on dialysis. For each eligible patient data will be collected for 6 months. Target sample size is 5000-7000 patients.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients \>/=18 years of age
* Dialysis patients with chronic renal anemia
* Written informed consent

Exclusion Criteria:

* Red blood cell transfusion in the previous 2 months
* Severe neuropsychological disorder
* Diabetic patients with serious complications

This trial is being conducted in Morocco.
Efficacy of Rice Bran Extract in Mildly to Moderately Depressed Adults

The investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects and tolerability of rice bran extract on depressive symptoms and related biomarkers in mildly to moderately depressed patients for 8 weeks.

A previous animal study has indicated that rice bran extract provided inhibition of MAO-B enzyme activity and ROS formation in a corticosterone-induced depression-like animal model. Therefore, the investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects of rice bran extract on depressive symptoms and related biomarkers in mildly to moderately depressed patients for 8 weeks; the safety of the compound is also evaluated. The Investigators examine the Korean version of the Hamilton Depression Rating Scale, the Korean Version of the Beck-II Depression Inventory, the Korean version of the Patient Health Questionnaire-9, the Perceived Stress Scale, the Korean version of the Beck Anxiety Inventory and biomarkers at baseline and after 8 weeks of intervention. One hundred adults were administered either 1,000 mg of rice bran extract or a placebo each day for 8 weeks.

Eligibility Criteria:
Inclusion Criteria:

- the Korean version of the Hamilton Depression Rating Scale score between 7-24

Exclusion Criteria:

* No depressive symptom (K-HRSD ≤ 6) or severely depressed (K-HRSD ≥ 25)
* Those are taking hormone therapy such as estrogen within the past 6 months
* Those are taking the following drugs within the last 1 month or need to take them during the study period (sleep aids, antidepressants, selective estrogen receptor modulators, etc.)
* Those with a history of treatment for depression
* Abnormal liver or renal function (more than twice the normal upper limit of the research institute)
* Uncontrolled diabetes mellitus (\>160 mg/dL of fasting blood sugar)
* Uncontrolled hypertension (\>160/100 mmHg)
* Uncontrolled thyroid diseases.
* Those who are taking drugs, functional foods, herbs, etc. that may affect depression
* Alcohol abuser
* Allergic reaction to this test food
* Those who participated in other drug clinical trials within 1 month from the screening date.
* Severe gastrointestinal symptoms such as heartburn and indigestion
* Those who are pregnant, lactating, or plan to become pregnant during the clinical trial
* Those who are judged to be unsuitable by the PI for other reasons