cyrilzakka/clinical-trials huggingface dataset:
Stress-Reducing Intervention in Patients With Colorectal and Breast Cancer

The goal of this interventional study is to test the heart-rate variability biofeedback intervention (HRV BI) in 2 cohorts of patients. Cohort A will evaluate the effect of the addition of HRV BI in patients with breast cancer treated in the neoadjuvant setting (vs. standard of care alone, SOC) followed by local therapy (surgery +/-radiotherapy). Cohort B will evaluate the effect of the addition of HRV BI in patients with colon cancer after surgery in the adjuvant setting (vs. standard of care alone, SOC).

This is a prospective, interventional, clinical study with in 2 cohorts. Target of subjects is 50 per cohort and an anticipated total duration of 36 months.

Participants will undergo 4 sessions of HRV BI with the trainer where they will learn about the prognostic role of the vagal nerve in cancer and in reducing distress and pain, and how to perform deep paced breathing with the HRV monitoring. They will perform the training daily (3-times, minimum 7 minutes each) at home with the online control for 3 months.

Researchers will compare the effect of addition of 3-months training of HRV BI to SOC on inflammation, HRV, quality of life (QoL), cognitive functions, salivary cortisol slopes, sleep quality and treatment outcomes of patients with colorectal and breast cancer.

Eligibility Criteria:
Inclusion Criteria:

1. Patients older than 18 years.
2. Pathologically confirmed breast cancer indicated for neoadjuvant systemic treatment or colon cancer after curative surgery indicated for adjuvant systemic treatment.
3. Adequate renal functions: measured or calculated (by Cockcroft formula) creatinine clearance \> 60 ml/min.
4. Absolute granulocytes count ≥ 1,500/mm3, platelets ≥ 100,000 mm3, bilirubin ≤ 1.5x the upper limit of normal value.
5. Adequate liver functions defined by AST (Aspartate aminotransferase) and ALT (Alanine transaminase) ≤ 3xUNL (upper normal of limit).
6. Basic computer skills of patient or his family member.
7. Signed informed consent.

Exclusion Criteria:

1. Previous chemotherapy.
2. Previous malignancy, except for basal-cell carcinoma of the skin within last 5 years.
3. Patients with know primary immunodeficiency and patients infected by the Human Immunodeficiency Virus (HIV).
4. Patient receiving long term corticosteroid treatment, anti-arrhythmic drugs and opioids who can not withdraw the treatment for the period of application of the heart rate variability (HRV) biofeedback training.
5. Patients with diabetes mellitus, cardiac arrhythmia, cardiac pacemaker implant.
6. Patients who do not fit inclusion criteria.
Phase III Trans-Arterial Chemo-Embolization (TACE) Adjuvant HCC

The purpose of this study is to compare the Overall Survival (OS) of HCC patients who receive brivanib as adjuvant treatments to TACE therapy, with the OS of HCC patients who receive matched placebo with TACE therapy.


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

Inclusion Criteria:

* Patients with diagnosis of hepatocellular carcinoma
* Cirrhotic status of Child-Pugh Class A or B with a score of 7
* ECOG performance status of 0 or 1
* Adequate hematologic, hepatic, and renal function

Exclusion criteria:

* Prior use of any systemic anticancer chemotherapy, immunotherapy, investigational or molecular targeted agents for HCC
* History of cardiac disease
* Active and untreated hepatitis B
* Inability to swallow tablets or untreated malabsorption syndrome
* History of human immunodeficiency virus (HIV) infection
Quality of Life in Children Treated for Cancer

RATIONALE: Questionnaires that measure quality of life may improve the ability to plan treatment for children with cancer.

PURPOSE: This randomized clinical trial is studying the quality of life in children treated for cancer.

OBJECTIVES: I. Assess the validity and reliability of a quality of life questionnaire (MM-QOL) that is being developed for patients with previously or currently treated childhood cancers.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age (8-12 vs 13-20) and treatment (current vs previous). Patients are randomized to one of two arms of the study. Arm I (Reliability): Patients will complete the same questionnaire two weeks apart. (age 13-20 stratum closed as of 7/14/00) Arm II (Validity): Patients will complete a study questionnaire plus a Child Health Questionnaire. Patients between ages 8-12 are interviewed and patients between ages 13-20 complete a written questionnaire.

PROJECTED ACCRUAL: A total of 716 patients (416 for arm I (208 for 8-12 age group and 208 for 13-20 age group) and 300 for arm II (150 for 8-12 age group and 150 for 13-20 age group)) will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Prior or current diagnosis of any pediatric cancer Current chemoradiotherapy (at least 2 months since start of therapy) OR At least 1 year since prior treatment and in remission

PATIENT CHARACTERISTICS: Age: 8 to 20 Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics Surgery: Not specified
AMISH : Aprovel for Management of Isolated Systolic Hypertension

To compare the antihypertensive efficacy and tolerability of irbesartan and irbesartan-hydrochlorothiazide fixed combination therapy with amlodipine and amlodipine plus hydrochlorothiazide in the treatment of isolated systolic hypertension.


Eligibility Criteria:
Main criteria are listed hereafter:

Inclusion Criteria:

* at Screening

  * Outpatients
  * With newly diagnosed and untreated OR previously diagnosed, treated and uncontrolled Isolated Systolic Hypertension defined as:

    * seated Systolic Blood Pressure (SBP) ≥ 160mmHg and \< 220 mmHg \[160-220\[
    * AND seated Diastolic Blood Pressure (DBP)\< 90 mmHg
* at Randomization

  * Having completed the 2 to 4-week wash-out/placebo run-in phase
  * Still eligible for Blood Pressure
  * seated SBP ≥ 160mmHg and \< 220 mmHg \[160-220\[
  * AND seated DBP \< 90 mmHg.

Exclusion Criteria (at Screening):

* Participation in a clinical trial within the previous 3 months
* Patients with a history of irbesartan, amlodipine, or hydrochlorothiazide sensitivity defined as irbesartan, amlodipine, or hydrochlorothiazide discontinuation due to medically significant adverse effects
* Patients currently or previously treated with Angiotensin II Receptor Blocker (irbesartan, losartan, candesartan, valsartan, telmisartan, etc.) or dihydropiridine Calcium Channel Blocker (amlodipine, nicardipine, felodipine, nifedipine, etc.) AND not responding despite maximum tolerated dose
* Known or suspected secondary hypertension (e.g., coarctation of aorta, renovascular stenosis, etc.)
* Known single functional kidney
* History of recent myocardial infarction, coronary artery bypass graft surgery or percutaneous transluminal coronary angioplasty, or cerebrovascular accident (Transient Ischaemic Attack, stroke) within the last 6 months of study entry
* Patients with known gastrointestinal, renal, hepatic, endocrine, cardiovascular, pulmonary, immunological or hematological disease which in the opinion of the investigator is active or uncontrolled
* Patients with significant renal (clearance of creatinine \< 30 mL/mn), hepatic or cardiac insufficiency, or known valvular heart disease
* Serum potassium \< 3.5 mmol/L (mEq/L) or \> 5.5 mmol/L (mEq/L)
* Presence of clinically significant ventricular or supraventricular arrhythmias, or second or third degree atrioventricular block, or QTc prolongation (Bazett \> 450 msec.) on the ECG
* Pregnancy or lactation. Women of child bearing potential (not post-menopausal) should be using a reliable contraceptive method

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Prospective, Randomized Clinical Trial Comparing Macular Photocoagulation With or Without Intravitreal Bevacizumab or Triamcinolone for the Treatment of Diabetic Macular Edema

Purpose: To compare the effects of macular photocoagulation with or without intravitreal bevacizumab (IVB) or triamcinolone (IVTA) for the treatment of diabetic macular edema (DME). Casuistic and Methods: 58 eyes of 44 patients with diffuse DME were randomized to receive either IVB + focal/grid laser (IVB-Laser, n=19), IVTA + focal/grid laser (IVTA-Laser, n=16) or focal/grid laser alone (Laser, n=23). Ophthalmic evaluation, including best-corrected visual acuity (BCVA), intraocular pressure (IOP) and central macular thickness (CMT) were performed at baseline and monthly for 12 months.


Eligibility Criteria:
Inclusion Criteria:

1. clinically significant diabetic macular edema (DME) with diffuse leakage involving the center of the fovea, with DME greater than 275 microns in OCT examination
2. BCVA between 0.3 LogMAR (logarithm of smaller angle of visual resolution) (20/40) and 1.6 LogMAR (20/800)
3. signed of inform Consent.

Exclusion Criteria:

1. HbA1c levels greater than 10%
2. thromboembolic event history (including myocardial infarction and stroke)
3. vitreo-macular traction on OCT
4. coagulation disorders
5. macular ischemia on fluorescein angiography examination
6. proliferative diabetic retinopathy that required treatment
7. eye surgery
8. history of ocular hypertension or glaucoma
9. any ocular pathology which in the opinion of the investigator, could macular edema or change the visual acuity during the study period (for example, retinal vascular occlusion, uveitis or other inflammatory eye disease, neovascular glaucoma)
10. systemic corticosteroid therapy
11. any conditions that could affect the documentation
12. any previous treatment for diabetic macular edema.
Trial of Microplasmin Intravitreal Injection for Non-Surgical Treatment of Focal Vitreomacular Adhesion. The MIVI-TRUST (TG-MV-007) Trial.

This trial will evaluate the safety and efficacy of microplasmin, administered as an intravitreal injection, in subjects with focal vitreomacular adhesion. In previously performed clinical trials, some patients treated with intravitreal microplasmin have had resolution of their underlying condition, including macular hole closure, without need for vitrectomy. This clinical trial is justified because the sponsor believes the potential benefits outweigh the potential risks.


Eligibility Criteria:
Inclusion Criteria:

* Presence of focal vitreomacular adhesion (i.e., central vitreal adhesion within 6 mm Optical Coherence Tomography (OCT) field surrounded by elevation of the posterior vitreous cortex) that in the opinion of the Investigator is related to decreased visual function (such as metamorphopsia, decreased visual acuity, or other visual complaint)

Exclusion Criteria:

* Any evidence of proliferative retinopathy (including Proliferative Diabetic Retinopathy (PDR)) or other ischemic retinopathies involving vitreoretinal vascular proliferation) or exudative Age-Related Macular Degeneration (AMD) or retinal vein occlusion in the study eye
* Subjects with any vitreous hemorrhage or any other vitreous opacification which precludes either of the following: visualization of the posterior pole by visual inspection OR adequate assessment of the macula by either OCT and/or fluorescein angiogram in the study eye
* Subjects with macular hole diameter \> 400 µm in the study eye
* Aphakia in the study eye
* High myopia (more than 8D) in study eye (unless prior cataract extraction or refractive surgery that makes refraction assessment unreliable for myopia severity approximation, in which case axial length \>28 mm is an exclusion).
Beans/Bran Enriching Nutritional Eating For Intestinal Health Trial

The purpose of this study is to explore the effects of cooked navy bean powder or rice bran consumption on the stool microbiome and metabolome of colorectal cancer survivors and healthy adults.

Objectives:

1. To learn about how increased cooked navy bean powders or rice bran dietary intake affect the stool microbiota of colorectal cancer survivors and healthy adults.
2. To determine whether cooked navy bean powders or rice bran consumption modulate microbial metabolism.
3. To observe dietary changes in the blood, urine and stool metabolite profiles and inflammatory cytokines.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years of age.
* Be a Colorectal Cancer Survivor that is a minimum of 4 months post chemotherapy/radiation treatment. OR be a healthy adult with no prior history of treatment for cancer.
* BMI between 25-35
* no previous or concurrent malignancy except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer and other cancer for which the patient has been disease free for five years.
* Ability to complete questionnaire(s) and dietary food logs
* Willingness to consume meals/snacks provided for 28 consecutive days
* Drink less than or equal to one alcoholic drink/day

Exclusion Criteria:

* History of food allergies and/or major dietary restrictions
* Pregnant or lactating or planning to become pregnant
* Self identified as a smoker
* Taking prescribed medication to control their lipids
* Taking Bean-O, other anti-flatulence medications or prolonged antibiotic use (one month)
* Have a history of gallstones.
Sequential Combination Therapy With PD-1 Antibody and Peg-IFNα in CHB Patients

This is a prospective study to evaluate the safety and efficacy of Sintilimab (PD-1 antibody) in sequential combination with Peg-IFNα-2b in NA-supressed CHB patients who had previously received Peg-IFNα therapy.


Eligibility Criteria:
Inclusion Criteria:

* 1. 18 - 65 years old;
* 2.Chronic hepatitis B patients with clear diagnosis of hematology, etiology and clinical (for example: HBsAg positive for more than 6 months);
* 3. In virologically suppressed (HBV DNA below the lower detection limit) CHB patients by NAs treatment, HBsAg decreased by less than 0.5log in the last 6 months of Peg-IFNα therapy, and then discontinued Peg-IFNα at least 6 months;
* 4.Patients with HBV DNA negative, HBeAg negative, HBsAg quantification ≤ 200IU/ml at Peg-IFNα discontinuation and enrollment.

Exclusion Criteria:

* 1. Cirrhosis;
* 2.platelet count \< 90×109/L, WBC count \< 3.0×109/L, neutrophil count \< 1.3×109/L, ALT \> ULN (40U/L), total bilirubin \> 2ULN;
* 3.History of or suspicion of hepatocellular carcinoma
* 4.Patients received immunosuppressive therapy or other therapy influenced study within 12 months;
* 5.Hepatitis A, hepatitis C, hepatitis D, HIV infection or other active infections;
* 6.Alcohol or drug abuse/dependence;
* 7.Investigator judges that the participants are not suitable for this study.
Dietary Bioflavonoid Supplementation for the Prevention of Neoplasia Recurrence

Prove the hypothesis that dietary supplementation with bioflavonoids will diminish the recurrence rate of colonic neoplasia, we will implement a clinical trial comparing bioflavonoids and placebo in a double blind randomized clinical trial. To use a standardised supplementation of bioflavonoids, a commercially available preparation (Flavo-Natin®) will be used.

The preparation contains a mixture of 200mg chamomile and tea (green tea) extract which contains naturally occurring bioflavonoids (2%) together with vitamins and folic acid. This flavonoids mixture will be applied for 3 years and the compliance and effects of this treatment will be determined by measuring the serum concentrations of apigenin and EGCG of the patients.

Eligibility Criteria:
Inclusion Criteria:

* Patient who had a recent surgical resection of colorectal cancer with pathologically proven stage 2 or stage 3 (without adjuvant chemotherapy or after completion of adjuvant chemotherapy) according to UICC. The time interval for recruitment should be within 3-12 month after surgery.
* Male or female
* caucasian
* 50 to 75 years old
* Broca-index: between -20 and +25%
* who are willing and capable to confirm written consent to enrolment after ample information has been provided
* who are in a stable condition that it can be expected that no changes in relevant medical conditions will occur during the study

Exclusion Criteria:

* subjects with any major relevant clinical abnormality (as based on extensive medical history, physi-cal examination, vital signs)
* subjects with active cancer
* subjects with any major clinically relevant laboratory abnormality.
* subjects who participated in another trial with any investigational substance within the last 4 weeks
* subjects who are known or suspected to be (social) drug dependent, incl. those drinking more than moderately and who are not willing to abstain from alcohol abuse during the active study phase
* subjects who adhere to a extreme diet or lifestyle that might interfere with the investigation
* subjects who are known or suspected not to comply with the study directives and/or who are known or suspected not to be reliable or trustworthy
* subjects who are known or suspected not to be capable of understanding and evaluating the in-formation that is given to them as part of the formal information policy (informed consent), in par-ticular regarding the risks and discomfort to which they would agree to be exposed
Heterogeneity of Neointimal Healing Following Biodegradable-polymer Drug-Eluting Coronary Stent Implantation

The objective of this study is a comparative evaluation of Orsiro stent and of Resolute Integrity stent in terms of the extent of neointima formation at 4 months after implantation using optical coherence tomography (OCT).

About 50 patients with clinical evidence of ischemic heart disease and / or a positive functional study and documented stable angina pectoris (Canadian cardiovascular society classification (CCS)1, 2, 3 or 4), or documented silent ischemia in de-novo, native, previously unstented vessel in Tyumen Cardiology Center,will be randomly assigned undergoing implantation of Orsiro stent or Resolute Integrity stent (in a 1:1 ratio).

All of the patients will receive 12 months dual antiplatelet therapy and they will be followed (at the outpatient clinic) for up to 1 year. The follow-up visits will be conducted at 4 months (including angiographic/OCT investigation), and 1 year post percutaneous coronary intervention(PCI),in order to observe the Primary Endpoint and Secondary Endpoints.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years;
* Patients with symptoms of stable angina and/or presence of a positive functional test for ischemia;
* Patient is eligible for percutaneous coronary intervention (PCI);
* Patient has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as approved by the Ethical Committee of the respective clinical site.

Exclusion Criteria:

* Target lesion involving a bifurcation with a side branch ≥2.0 mm in diameter;
* Target lesion located in the left main stem;
* Target lesion is located or supplied by an arterial or venous bypass graft;
* Lesion located very distally, difficult to be imaged by OCT;
* Co-morbidities that could interfere with completion of study procedures, or life expectancy less than 1 year;
* Participating in another investigational drug or device trial that has not completed the primary endpoint or would interfere with the endpoints of this study;
* Patient underwent target vessel revascularization with a DES;
* Patient presenting with acute myocardial infarction with ST elevation;
* Cerebrovascular accident within the past 12 months;
* Acute or chronic renal dysfunction (defined as creatinine greater than 2.0 mg/dl);
* Patient receiving oral anticoagulants
Eculizumab for Prevention of Antibody-Mediated Rejection in ABO-Incompatible Living Donor Kidney Transplantation

The aim of this study is to determine whether a single dose of eculizumab can effectively prevent antibody-mediated rejection in recipients undergoing living donor kidney transplantation with a different ABO blood group type than their donors

Kidney transplantation is considered the best therapy for patients with end-stage renal disease. ABO-incompatible living donor kidney transplantation (ABOi-LDKTx) is one of the strategies to expand the pool of donors. However, the blood group antibodies in recipients can lead to acute rejection, resulting in transplant failure. Before transplantation, the use of rituximab (RTX) to remove B cells; plasmapheresis to eliminate blood group antibodies can mitigate the occurrence of acute rejection and enhance the success rate of transplantation.

The complement system plays a vital role in antibody-mediated rejection (AMR). Eculizumab can target the C5 protein of the complement system and then block the activation. Therefore, we hypothesize that the pretransplant use of eculizumab may prevent the AMR in ABOi-LDKTx.

Eligibility Criteria:
Inclusion Criteria:

1. aged ≥ 18 years, male or female
2. Suffering from end-stage renal disease and planning for ABO blood group incompatible living donor kidney transplantation
3. Vaccinated against Neisseria meningitides (quadrivalent vaccine), Pneumococcus or H. influenzae at least two weeks prior to using eculizumab
4. Be able to understand the informed consent form and willing to comply with the protocol

Exclusion Criteria:

1. Previous splenectomy
2. Any active bacterial or other infection
3. Known or suspected hereditary complement deficiency
4. Known hypersensitivity to the treatment drug or any of its excipients
5. History of Neisseria meningitidis
6. Any health condition that the investigator believes may interfere with the patient's participation, pose additional risks to the patient, or confound with the patient's assessment (e.g. severe cardiovascular or pulmonary disease)
Maternal Counseling for Preterm Deliveries, Assessing an Effective Method of Counseling

Providing verbal counseling supplemented with both written and pictorial information then verbal counseling alone is a more effective method of counseling parents with threatened preterm delivery

Progress in the frontiers of neonatology has continually pushed back the limit of viability and significantly improved the survival of extremely preterm infants. An important component of medical management before a preterm delivery is counseling the parents about probabilities of survival and long term complications.

Hypothesis: Preterm counseling is more effective when parents receive verbal counseling supplemented with written and pictorial information then verbal counseling alone.

Methodology: There will be two groups of study (verbal, pictorial and written vs verbal alone). All patients admitted to the L and D department of Stroger hospital between 23 to 34 weeks of gestation with threatened premature delivery will be enrolled in the study. They will be randomly assigned to 1 of 2 groups. After counseling, parents will be asked to complete a 32 point questionnaire to check their knowledge of outcomes of prematurity.

To reach statistically significant results, the investigators will need 40 patients in each group. The study will be done over a period of one year

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women between 23 to 34 weeks gestation assessed by obstetrician to need counseling

Exclusion Criteria:

* Pregnancies with known life threatening defects considered as non compatible with life.
* Mothers previously admitted and counseled will also be excluded