cyrilzakka/clinical-trials huggingface dataset:
Hemoglobin Trend in Neonates and Toddlers Post Cardiac Surgery

Many toddlers and children are released home with relatively low hemoglobin levels following cardiac surgery, and with no careful follow up, at an age at which anemia is common. At this age, breast milk and its substitute do not provide enough iron, and parents are not adherent enough to iron supplements. Due to these facts, there is high importance, especially in children suffering from heart defects, for close follow up on their hemoglobin levels. Studies following hemoglobin trend post cardiac surgery were never done with children.

For the past 6 decades, children have been going through cardiac surgery to correct congenital heart defects. Over the years, there has been great improvement in morbidity and mortality post cardiac surgery due to better technical skill and post operative treatment. Most of those surgeries require cardio-pulmonary bypass machine, which requires the use of blood products, and many of those children also require blood product as part of the post operative care, especially those children with cyanotic heart defects. Many toddlers and children are released home with relatively low hemoglobin levels, and with no careful follow up, at an age at which anemia is a risk factor for developmental delay and decreased cognitive function. Iron deficiency is common in Israel among children aged 6-24 months. At this age, breast milk and its substitute do not provide enough iron, and parents are not adherent enough to iron supplements as recommended by the ministry of health. Due to these facts, there is high importance, especially in children suffering from heart defects, for close follow up on their hemoglobin levels. In adults, a study following hemoglobin levels post cardiac surgery during hospitalization only, showed that most (79%) starting showing improvement during their hospitalization. Another study in patients over the age of 50 post coronary artery bypass graft, showed no difference between a group receiving iron supplements and another not receiving any, after 2 months. Similar studies were never done with children.

Eligibility Criteria:
Inclusion Criteria:

* All children 0-18 months going through cardiac surgery during the 3 years of the study, after obtaining written consent from the parents/legal guardians.

Exclusion Criteria:

* None
Examining the Impact of Using Two Dialysers in Parallel on Dialysis Adequacy in Hemodialysis Patients

The purpose of this study is to investigate the effectiveness of using two dialysers to lower the blood mineral levels in people receiving hemodialysis as compared to using one dialyser (usual treatment).

Higher levels of serum phosphate are independently associated with an increased risk of death in hemodialysis patients. Therefore, there has been considerable interest in controlling serum phosphate while minimizing oral calcium load. While most attention has focused on the use of non-calcium containing phosphate binders such as sevelamer and lanthanum, modifying conventional dialysis regimens to improve phosphate clearance is an alternative approach that remains relatively unstudied. A secondary analysis of a previous randomized cross-over study from our group found that the use of two dialysers in parallel resulted in a reduction in pre-dialysis serum phosphate levels. As this study was small, and the mechanisms resulting in the reduction in phosphate levels were unclear, further study is warranted. The investigators will conduct a randomized cross-over study comparing the impact of dialyzing using two dialysers in parallel with a single dialyser in hyperphosphatemic hemodialysis patients.

There will be a total of 34 participants from Alberta,Canada participating in this study. The length of study participation is 10 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Patients must be on a stable regimen of hemodialysis for ≥ 3 months ('stable' defined as not expected to require a change to the duration or frequency of treatments)
* Serum phosphate \> 1.6 mmol/l on last two consecutive lab tests at least 3 weeks apart (KDOQI guidelines recommend maintaining predialysis phosphate \< 1.8mmol/l - as such, phosphate lowering in this subgroup of patients is particularly relevant)
* Patients must be on stable doses of a phosphate binder with no changes in dose 1 month prior to study enrolment.
* Blood flow rate ≥ 350 ml/min through a well-functioning access (This will exclude patients receiving inadequate dialysis due to a temporary venous dialysis catheter and will ensure sufficient blood flow to permit dialysis using two dialysers in parallel.)

Exclusion Criteria:

* Patients who have a scheduled renal transplant, change in dialysis modality, surgery or hospitalization or plan on moving away from the study site in the next three months.
* Patients with a projected life expectancy of less than 3 months.
* Patients with a contraindication to intra-dialytic anticoagulation. (Some patients require a small increase in the amount of anticoagulation required to prevent dialyser clotting when using two dialysers in parallel).
* Patients who have missed \>8 dialysis treatments in the past 3 months.
* Patients with a dialysis regimen of \>3 runs per week.
* Failure to provide informed consent.
* Patients enrolled in another (interventional) trial
Innovative Models in the Rehabilitation of the Elderly With Hip Fractures Through Technological Innovation

The final goals of the present study is to propose a new approach in the hip fracture rehabilitation in elderly subjects, focused on the use of robotic device and to check the results not only at the end of the treatment but also in the long term, foreseeing 3 follow-up.

Balance and deficit in walking are some of the main characteristics of aging and are considered among the risk factors for falls. Falls are a risk factor for future falls and are associated with other adverse health outcomes such as fear of falling or fractures. In particular, hip fracture in aged patients is an important health problem. In fact, one in three patients dies within the first year after injury, while survivors have poor quality of life For this reason, the development of prevention tools and innovative strategies in the rehabilitation field should be one of the main objectives in the treatment of the diseases afflicting the elderly, such as hip fractures. Effective interventions to promote hip recovery post hip fracture are characterized by intensive and repetitive movements. One treatment approach to increase number of steps during rehabilitation sessions and to improve the balance and the endurance of the patients is the use of robotic systems.

This study is a randomized controlled trial. A total of 195 patients with hip fractures will be recruited and randomly divided into three groups, to receive a traditional rehabilitation program or a robotic rehabilitation in addition to the traditional therapy. Assessments will be performed at baseline, at the end of treatment and 6 months, 1 year and 2 years from the end of the treatment. For the study, post-hospitalization subjects will be taken into consideration, after four weeks from the hospitalization. A 20 treatment sessions will be conducted, divided into 3 training sessions per week, for 7 weeks. The control group will perform traditional therapy sessions lasting 50 minutes. The technological intervention group will carry out 30 minutes of traditional therapy and 20 minutes of treatment with a robotic system.

Eligibility Criteria:
Inclusion Criteria:

* Capacity to consent
* Traumatic event within 60 days
* Romberg test: negative
* Functional Ambulation Category (FAC) score ≤ 2
* Ranking scale score ≤ 3;

Exclusion Criteria:

* Past history of syncopal episodes
* Presence of non-pharmacologically compensated behavioral syndromes
* Presence of pain that prevents walking or standing
* Presence of neurological pathologies that compromise balance (Multiple sclerosis, Parkinson's disease, stroke, ataxias, poliomyelitis)
* Spinal stenosis
* Radiculopathy
* Neuropathies lower limbs
* Disabling disabilities that impair walking (eg congenital malformations of the foot)
* Heterometry \> 2 cm
* Clinical dementia rating (CDR) score ≥ 3
* Severe systemic diseases with life expectancy \< 1 year
* Patients unable to follow up.
Brain Imaging Study

The study is designed to evaluate the effects of the proprietary nutritional supplement on cognition, mood, and brain imaging parameters following a relatively short period of treatment.


Eligibility Criteria:
Inclusion Criteria:

* Both male and female subjects will be included.
* Age between 40-60 years inclusive.
* Healthy subjects who, in the opinion of the investigator, are free of any medical conditions that might affect study measures.
* Eats 1 or fewer servings of fatty fish per week.
* BMI \< 35

Exclusion Criteria:

* Current or past neurological illness.
* Substance abuse or dependence within the prior 60 days.
* Current depression (HAMD greater than 20) or anxiety disorder (HAMA greater than 18).
* Current or past history of psychiatric disorder.
* History of head trauma with loss of consciousness.
* Contraindication to brain MRI examination.
* Supplementation with Omega 3, fish oil, or other over the counter supplements including the other bioactive ingredients in the proprietary nutritional supplement, antioxidants and multi-vitamin mineral supplements for the previous 3 months.
* Plasma Omega3 Index \>5% at screening visit.
* Subject has a known allergy or intolerance to any of the ingredients contained in the proprietary nutritional supplement or placebo.
* Subject is currently pregnant, planning to become pregnant, or is breastfeeding.
Lubricity Post-Wear - Competitive Lenses Pilot

The purpose of this study is to measure the coefficient of friction of three silicone hydrogel, daily disposable contact lenses after 16 hours of wear.

In this 3-treatment, 3-period, 6-sequence crossover study, each participant will wear all 3 products in randomized order, 1 product at a time, with a washout period of up to 7 days between treatment periods. Lenses will be collected for ex-vivo lubricity analysis. The ex-vivo lubricity analysis will be conducted under a separate non-clinical protocol.

Eligibility Criteria:
Inclusion Criteria:

* Must sign an informed consent form.
* Soft contact lens wearer (both eyes).
* Willing to wear study lenses at least 16 waking hours and attend all study visits.
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

* Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear.
* Use of systemic or ocular medications for which contact lens wear could be contraindicated.
* Use of artificial tears and rewetting drops during the study.
* Monocular (only 1 eye with functional vision) or fit with only 1 lens.
* History of herpetic keratitis, ocular surgery, or irregular cornea.
* Pregnant.
* Other protocol-specified exclusion criteria may apply.
A Study to Determine the Efficacy and Safety of Finerenone on Morbidity and Mortality Among Hospitalized Heart Failure Patients

Finerenone will be compared to placebo to determine efficacy and safety of treatment in patients hospitalized with acute decompensated heart failure (HF) and mildly reduced or preserved left ventricular ejection fraction.

This is an international, randomized, double-blind, placebo-controlled, event-driven trial of finerenone for the treatment hospitalized heart failure patients with mildly reduced or preserved ejection fraction.

Eligibility Criteria:
Inclusion Criteria:

* Provide electronic or written informed consent, either personally or through a legally authorized representative
* Age ≥18 years
* Current hospitalization or recently discharged with the primary diagnosis of heart failure
* Heart failure signs and symptoms at the time of hospital admission
* Imaging evidence of mildly reduced or preserved left ventricular ejection fraction (EF) (40% or higher)
* Elevated N-terminal pro B-type natriuretic peptide (NTproBNP) ≥1000 pg/mL or B-type natriuretic peptide (BNP) ≥250 pg/mL for patients without atrial fibrillation (AF); or elevated NTproBNP ≥2000 pg/mL or BNP ≥500 pg/mL for patients with AF

Exclusion Criteria:

* Treatment with a mineralocorticoid receptor antagonist (MRA)
* Documented prior history of severe hyperkalemia in the setting of MRA use
* Estimated glomerular filtration rate (eGFR) \<25 mL/min/1.73m² or serum/plasma potassium \>5.0 mmol/L at screening
* Acute myocardial infarction, coronary revascularization, valve replacement/repair, or implantation of a cardiac resynchronization therapy device within 30 days
* Hemodynamically significant (severe) uncorrected primary cardiac valvular disease
* Cardiomyopathy due to known acute inflammatory heart, infiltrative diseases, accumulation diseases, muscular dystrophies, cardiomyopathy with reversible causes, known hypertrophic obstructive cardiomyopathy, complex congenital heart disease, or known pericardial constriction
* Probable alternative cause of participant's heart failure symptoms
* Concomitant systemic therapy with potent cytochrome P450 isoenzyme 3A4 (CYP3A4) inhibitors or moderate CYP3A4 inducers, or potent CYP3A4 inducers
Study to Assess Perfusion and Patient Satisfaction in Nipple-Areola Mastectomy With Immediate Reconstruction

The investigators hypothesize that nipple-areola skin sparing mastectomy (NASSM) performed through an inframammary incision has a superior blood supply relative to a lateral oblique incision. Moreover, by minimizing complications and optimizing aesthetic outcomes, the investigators believe it will be associated with significantly higher patient reported outcome scores. The addition of information gained by use of intraoperative laser-assisted fluorescent angiography (measured with the Spy Elite imaging device) will reduce complication rates by directing intraoperative resection of ischemic tissue and limiting the volume of immediate implant placement in instances where real time imaging would suggest compromised perfusion. These quantifiable, objective measures will justify the use of NASSM and immediate implant placement coupled with intraoperative laser-assisted fluorescent angiography in prosthetic based breast reconstruction despite longer operative times.


Eligibility Criteria:
Inclusion Criteria:

* Patient must be scheduled to undergo either a single or bilateral elective nipple-areola skin sparing mastectomy (NASSM) procedure with planned immediate reconstruction.
* Patient must be 18 years of age or older.
* Karnofsky Performance Scale of at least 80%.
* Patient must be able to understand and willing to sign a written informed consent document.

Exclusion Criteria:

* Cognitive impairment.
* BMI \< 18 or \> 35
* Breast \>800 grams or \<100 grams in predicted weight. "Breast" includes the breast tissue and in cases where the patient already has cosmetic breast implants, the additional breast implant mass. The sum total must be \>100 g and \<800 g.
* History of radiation to the chest wall or breast being studied
* Patients who have a history of allergy to iodides or iodinated contrast agents
* Surgeon's opinion at the time of surgery that the subject's well-being would be compromised (e.g. significant comorbidities, intraoperative findings of a higher stage cancer or other independent acute health problems). If the contralateral breast is undergoing a nipple-sparing mastectomy with reconstruction as well, then the contralateral breast can be studied so long as there is no compromise to any element of their care.
Low Dose Hemi-body Radiation For Recurrent Prostate Cancer

Older studies in animals and humans have shown cancer responses to very low doses of whole-body or hemi-body radiation. To study the effects of low doses of radiation in patients with recurrent prostate cancer, investigators will enroll up to 21 patients for 10 fractions of low dose radiation, delivered over 5 weeks. Participants will be followed on study for 12 months, capturing PSA, CBC, QoL and blood samples for immunological analysis.


Eligibility Criteria:
Inclusion Criteria:

* A confirmed diagnosis of prostate cancer.
* Having undergone prior prostate surgery or radiotherapy or both.
* Evidence of recurrence of the disease as demonstrated by rising PSA levels. Patients are eligible if on androgen blockade or hormone naïve.

Exclusion Criteria:

* Prior treatment with chemotherapy and/or abiraterone and/or enzalutamide and/or radium-223.
* Receiving treatment with immunosuppressive medications.
* Platelet count below 50,000/µl (50 x 109/l) or leukocyte count below 3,000/µl (3 x 109/l) or granulocyte count below 2,000/µl (2 x 109/l).
* Other medical conditions or co-morbidities which, in the opinion of the Investigator, may interfere with the participant's ability to participate in the study.
* Language difficulties which may hinder the patient's ability to complete the trial.
* Inability of the potential participant to provide consent.
* Lack of independence in daily living activities and any other conditions which, in the opinion of the Investigator, will hinder the participant's ability to participate and complete the study obligations.
Phase 1/2 Study of MRTX849 in Patients With Cancer Having a KRAS G12C Mutation KRYSTAL-1

This study will evaluate the safety, tolerability, drug levels, molecular effects, and clinical activity of MRTX849 (adagrasib) in patients with advanced solid tumors that have a KRAS G12C mutation.

This study will evaluate the safety, tolerability, pharmacokinetics, metabolites, pharmacodynamics, and clinical activity of MRTX849 (adagrasib) in patients with advanced solid tumors with a KRAS G12C mutation. MRTX849 (adagrasib) is an orally-available small molecule inhibitor of KRAS G12C.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed diagnosis of a solid tumor malignancy with KRAS G12C mutation
* Unresectable or metastatic disease
* Standard treatment is not available or patient declines; first-line treatment for NSCLC for certain cohorts
* Adequate organ function

Exclusion Criteria:

* History of intestinal disease or major gastric surgery or inability to swallow oral medications
* Other active cancer
Colchicine Randomized Double-Blind Controlled Crossover Study in Behcet's Disease

Colchicine was first used in Behcet's Disease (BD), in 1977. There are controversial reports of the efficacy of Colchicine in BD. For some experts the unresponsiveness of some patients could be explained by genetic difference between the Silk Road BD and sporadic BD from other parts of the world.

To test this hypothesis (the inefficacy of colchicine in the Silk Road BD), we designed a randomized double-blind controlled crossover study in Iran, which is in the middle of the Silk Road, and has the second highest prevalence of BD in the world.

Patients: They were selected as consecutive patients.

The entry criteria was: age between 14 and 60 years, confirmed diagnosis of Behcet's Disease, absence of major organ involvement (eye, brain, lung, and cardio-vascular involvement), having at least one active symptom, and no treatment for at least one month. Patients were explained the study design and they gave a signed written consent. During the two phases of study, if a major organ involvement appeared, the patient was moved out of the study. All patients fulfilled the new International Criteria for Behcet's Disease.

Method: patients were randomized at the study entry to take either colchicine or placebo. At 4 months, they were crossed over. Those who were taking colchicine went on placebo and those on placebo went on colchicine. Each patient tried therefore, both colchicine and placebo. The primary outcome was the effect of colchicine on the disease activity index, the IBDDAM (16-17). To calculate the overall IBDDAM of the baseline, the IBDDAM of the last 12 months (prior to the study) of each manifestation was calculated and added together. The overall disease activity index was then divided to the number of months (12 months) to have the mean activity index per month. IBDDAM was then measured every 2 months (in the middle and at the end, in each arm of the study). The total IBBDAM of the 4 months was then divided by 4 to have the mean activity index per month. The secondary outcome was to see how the individual symptoms responded to colchicine (IBDDAM of each manifestation).

Statistical analysis: The analysis was done by the intention to treat method. As the difference between IBDDAM before and after treatment had normal distribution Student T test for paired samples were used to evaluate the outcome in the colchicine and the placebo group. As the Levene's test showed the homogeneity of variance, ANOVA (one way) was used to test the effect of treatment (colchicine and placebo) and gender on patients' outcome. The dependent variable was the difference between IBDDAM (before and after the treatment). The independent variables were the treatment, and the gender. SPSS 15 was used for all statistical calculations.

Eligibility Criteria:
Inclusion Criteria:

* Patient's who fulfilled the International Criteria for Behcet's Disease.

Exclusion Criteria:

* major organ involvement
* Hypersensitivity reaction
Fourteen Day Safety of Low-Dose Tamoxifen in Patients With Chronic Hepatitis C Who Have Failed Standard Medical Therapy

A short 14 day phase 1 study examining 6 monotherapy doses of oral tamoxifen for safety in chronic HCV patients who have failed standard treatment of peginterferon and ribavirin.

Six different dosages of tamoxifen will be given for 14 days with safety and viral loads being measured.

Eligibility Criteria:
Inclusion Criteria:

1. HCV RNA positive.
2. failed standard therapy

Exclusion Criteria:

1. Cirrhosis on biopsy
2. Severe medical or psychiatric conditions that would make the evaluation difficult
3. Tamoxifen is a pregnancy category D drug so pregnant women must be excluded.
4. Patients with coumadin cannot be used from a drug interaction.
5. Active use of alcohol or illegal substances -
Efficacy and Security of an Endovascular Treatment as First Choice Procedure Compared With a Standard Intravenous Thrombolytic Therapy Treatment for Patients With Acute Ischemic Stroke Within 4.5 Hours After Onset

This study will compare two ways of treatment for acute ischemic stroke: an endovascular treatment (EVT), defined as intraarterial thrombolysis and/or mechanical thrombectomy as a first choice treatment versus intravenous thrombolytic therapy (IVT) only or followed by EVT in patients with acute ischemic stroke due to a main brain artery occlusion within 4.5 hours after onset. Patients treated with IVT only or with IVT followed by EVT will be analyzed separately.


Eligibility Criteria:
Inclusion Criteria:

* 80 or less years old patients with acute stroke produced by a main artery occlusion
* NIHSS National Institutes of Health Stroke Scale score greater than 6 (severe neurological impairment)
* Patients receiving EVT or IVT within 4.5 hours after onset

Exclusion Criteria:

* EVT or IVT contraindication
* Previous neurological impairment, severe concomitant disease or poor prognosis.
* Pregnancy or breastfeeding
* Known hypersensitivity to any study drugs
* Severe organic disease for which there is not risk compensation.