cyrilzakka/clinical-trials huggingface dataset:
Reasons for Mycophenolate Mofetil Dose Reduction and Impact on Graft Outcome in Renal Transplant Recipients

Mycophenolate mofetil (MMF) decreases the risk of acute rejection and is associated with improved graft survival in renal transplant recipients. However, MMF-related side effects often necessitate dose reduction which may expose transplant recipients to a higher risk of acute rejection and graft loss. This study's aim was to examine the reasons for MMF dose reduction during the first year after kidney transplantation and its impact on acute rejection, overall and death-censored graft loss. Methods: Retrospective electronic file based analysis of all patients who underwent a single kidney transplantation in our center between 1996 and 2007 and were treated with MMF as part of their initial maintenance immunosuppressive protocol (n=749).


Eligibility Criteria:
Inclusion Criteria:

* All patients who received a single renal transplant at the University Hospitals of Leuven between April 1996 (when MMF was introduced in the Leuven renal transplant program) and February 2007 and were treated with MMF (Cellcept®, Roche) as part of their initial maintenance immunosuppressive regimen were included in this retrospective analysis.

Exclusion Criteria:

* If a patient underwent more than one kidney transplantation in the abovementioned 11-year period, only the last was considered.
Dose Escalation Study of QR-010 in Homozygous ΔF508 Cystic Fibrosis Patients

A randomized, double-blind, placebo-controlled study of single and multiple ascending doses of QR-010 in adults homozygous for ΔF508 Cystic Fibrosis.

The purpose of this study is to evaluate the safety, tolerability, and to determine the pharmacokinetics of QR-010 administered via inhalation in adult homozygous for ΔF508 Cystic Fibrosis.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of CF as defined by iontophoretic pilocarpine sweat chloride test (sweat chloride) of \> 60 mmol/L
* Confirmation of CFTR gene mutations homozygous for the ΔF508 mutation
* Body mass index (BMI) ≥ 17 kg/m2
* Non-smoking for a minimum of two years
* FEV1 ≥70% of predicted normal for age, gender, and height, at Screening
* Stable lung function
* Adequate hepatic and renal function

Exclusion Criteria:

* Breast-feeding or pregnant
* Use of lumacaftor or ivacaftor
* Use of any investigational drug or device
* History of lung transplantation
* Hemoptysis
A Study of RO4607381 in Stable Coronary Heart Disease Patients With Recent Acute Coronary Syndrome

This study will evaluate the potential of RO4607381 to reduce cardiovascular morbidity and mortality in stable coronary heart disease patients with recent Acute Coronary Syndrome (ACS) and evaluate the long term safety profile of the drug. Eligible patients in stable condition will be randomized to receive either RO4607381 600mg po or placebo po, daily, together with a background of standard medication for ACS (including aspirin, antihypertensives and statins). The anticipated time on study treatment is 2+ years, and the target sample size is 15,600 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, \>=45 years of age;
* recently hospitalized for ACS;
* clinically stable;
* receiving evidence-based medical and dietary management of dyslipidemia.

Exclusion Criteria:

* uncontrolled diabetes;
* clinically unstable;
* severe anemia;
* uncontrolled hypertension;
* concomitant treatment with any other drug raising HDL-C (eg niacin, fibrates).
Blood Ammonia as Predictor for Esophageal Varices and Risk of Bleeding

Assessment of blood ammonia level as a non-invasive predictor for presence of EV and risk of bleeding

A prospective cross sectional study on 150 consecutive patients screening for esophageal varices.

Patient groups groups:

Group (1): 100 patients with esophageal varices

Group (2): 50 chronic liver disease patients with no esophageal varices as a control group.

All patients will be subjected to:

1. - Detailed history-taking
2. - Full clinical examination
3. - Laboratory investigations:

   * Complete blood picture (CBC)
   * Erythrocyte sedimentation rate (ESR)
   * Renal function tests
   * Liver function tests
   * Prothrombin time and activity
   * Viral markers (HCV Ab - HBV Ag)
   * Blood ammonia level.
4. - Pelviabdominal US: Ultrasound examination of the liver, portal venous system, spleen, kidney and other abdominal organs.
5. - Upper GITendoscopy:

   * Varices will be classified according to the Japanese classification 1996,
   * The Baveno 11 score will be used to differentiate between mild and severe portal hypertensive gastropathy.

Eligibility Criteria:
Inclusion Criteria:

* patients with chronic liver disease

Exclusion Criteria:

* Patient in hepatic encephalopathy or coma.
* Patient in active bleeding or with history of bleeding within the two weeks prior to entry in the study .
* Patients with heart failure.
* Patients with renal failure.
* Patient with hepatocellular carcinoma and portal vein thrombosis.
* Patient taking Beta blockers.
A Study in Adults to Test the Effects of Low Dose Thimerosal on Symptoms of COVID-19

Clinical trial to compare sublingual low does thimerosal in adults that have symptoms of SARS-CoV-2 Infection against placebo to show a difference in physical characteristics and viral levels.


Eligibility Criteria:
Inclusion Criteria:

* 40 years of age or older
* Provide written informed consent
* Have a SARS-COV-19 diagnostic test with positive results

Exclusion Criteria:

* Having an oxygen saturation level below 92% at baseline or currently on Oxygen therapy
* Subjects currently hospitalized
* Subjects who have received a COVID vaccination
* Subjects with a diagnosis of immunodeficiency
The SaVe Project-Sarcopenia and Vertigo in Aging Patients With Colorectal Cancer

The goal of this clinical trial is to learn about the cause of dizziness and decline in walking ability in in older adults ≥65 years during chemotherapy treatment for colorectal cancer. Another goal is to investigate if a comprehensive geriatric assessment and three months' specialized physical group-based exercise three times/week can counteract muscle weakness, vertigo, instability, impaired walking balance, and neuropathy

Frequent adverse effects of chemotherapy in older adults are nausea and fatigue, but our research group have discovered a problem with many also suffering from sarcopenia, vertigo, dizziness, and peripheral neuropathy (CIPN) leading to balance and walking impairments causing increased risk of falls. Moreover, these symptoms are often underreported with inadequate awareness among health professionals leading to deficient focus on the need for targeted rehabilitation. A comprehensive geriatric assessment (CGA) can increase the number of frail, older patients completing chemotherapy and CGA-based interventions can decrease chemotherapy toxicity and improve health-related quality of life (HRQoL). Physical exercise has been shown to reduce muscle weakness, vertigo, dizziness, and impaired balance among older adults requiring limited resources. Therefore, this project aims to investigate the effectiveness of CGA and physical exercise to counteract muscle weakness, vertigo, instability, and impaired walking balance, during chemotherapy and to investigate the interaction between vertigo, postural stability and walking performance, and neuropathy and the prevalence of sarcopenia. The activities of specialized physical exercise planned in this intervention will, as hypothesized, result in a change in muscle strength, walking balance, self-perceived balance disabilities/dizziness, and fear of falling along with changes in peripheral nerve function and autonomic function and severity of CIPN which are the outcomes of this study. Accordingly, expectations are that this intervention will affect the HRQoL among older cancer patients with vertigo and walking impairments and reduce the number of falls and hospital admissions leading to a socioeconomic benefit.

Eligibility Criteria:
Inclusion Criteria:

* Meet the criteria of the oncological departments of receiving neoadjuvant, adjuvant or first line palliative chemotherapy for colorectal cancer
* ≥65 years of age at the time of signing the informed consent form
* Able to speak and read Danish, and to provide a signed informed consent form
* Have an Eastern Cooperative Oncology Group (ECOG) performance status score of ≤2

Exclusion Criteria:

* Chemotherapy treatment within two years and sequelae of neuropathy, or symptoms of dizziness or vertigo, or balance disturbance
* Severe physical disability that hinders physical exercise
* Dementia, psychotic disorders, or other cognitive diseases or conditions that hinder participation in a clinical exercise-based trial
* Inability to sign informed content
* Patients who have had a consultation in the geriatric outpatient clinic within the past six months
Confirmatory Clinical Trial for Verifying the Efficacy and Safety of 'ALZGUARD' as a Digital Dementia Diagnostic Aid-Tool for the Diagnosis of the Major Neurocognitive Disorders

The goal of this clinical trial is to evalute the efficacy of ALZGUARD, a smartphone-based digital therapeutic(DTx), in comparison to diagnosis by medical doctors, as weel as to assess the safety of the application.

The study will be conducted across multiple sites, enrolling participants aged 55 to 85 years olds.

The primary objective of the study is to compare the diagnositic accuracy of ALZGAURD against traditional diagnostic evaluactions conducted by medical professionals. The primary endpoint for efficacy will be the Area Under the Curve(AUC), which will measure the diagnostic performance of the application. This statistical metric will help determine how well ALZGUARD can identify dementia compared to standard diagnostic methods.

Eligibility Criteria:
Inclusion Criteria:

* Participants must be between 55 and 85 years old (both men and women).
* Participants must be able to understand and voluntarily agree to the purpose, content, and procedures of the clinical trial.

Exclusion Criteria:

* Participants with no literacy or illiteracy.
* Participants with an intellectual disability.
* Participants with presenting active psychiatric symptoms.
* Participants who have difficulty ALZGUARD application
* Participants who are unable to use a smartphone, unless they can use it with assistant.
* Participants with a history of suicidal ideation or suicidal complusion in the last 6 months.
* Other conditions as deemed inappropriate for study participant by the Principal Investigator(PI).
Tolerance and Compliance of Infants Fed an Hydrolyzed Infant Formula

The objective of the study is to assess gastrointestinal tolerance and compliance in infants who require a hydrolyzed formula.


Eligibility Criteria:
Inclusion Criteria:

* Infant is 0 to 180 days of age
* Infant with persistent feeding intolerance symptoms; has had at least 1 formula switch OR infant is experiencing/being managed with an extensively hydrolyzed formula for suspected food protein intolerance or allergy or other condition where an extensively hydrolyzed formula is deemed appropriate
* Infant has not consumed an extensively hydrolyzed infant formula
* Use of prescription medications, OTC medications, home remedies, herbal preparations or rehydration fluids restricted
* Infant is not receiving steroids.
* Parent(s) confirm their intention to feed their infant the study product as the sole source of nutrition for the duration of the study
* Parent(s) confirm their intention not to administer solid foods or juices to their infant through the duration of the study.
* Parent(s) confirm their intention not to administer vitamin or mineral during the study

Exclusion Criteria:

• Participation in another study
Lactobacillus Reuteri in Children With Constipation

The most common cause of children chronic constipation is functional disorders. Functional constipation is diagnosed after excluding organic causes of constipation (anatomical, neurological, endocrinological) and identification of two symptoms defined by the Rome III criteria. There could be low number of bowel movements (below three times a week), defecation pain, fecal incontinence (once a week), stool consistency or occurrence of large diameter stools. The treatment is change of diet, defecation training and application of laxatives.

The probiotics are defined as living microorganisms, which provided in a proper doses should result in beneficial effect on a host health. The assessment of its characteristic is related to strain of bacteria affiliation.

Taking into the consideration that patients with constipation may experience microflora intestine disorders, using the probiotics can have the positive impact on process of treating this disease. The additional reason for using the probiotics during the constipation treatment is an influence of probiotics on movement of the alimentary canal.

In spite of proved effectiveness of some probiotics' strains further research are required, because clinical significance is ambiguous and the effect is confirmed among patients with short medical history. That's way the further analysis of probiotic Lactobacillus reuteri DSM 17938, which was successful treatment method of chronic constipation amongst children (infants) should be performed.

The primary aim of the study is the assessment of Lactobacillus reuteri DSM 17938 efficacy, provided with macrogol (Forlax), as treatment of constipation in 3-7 years old children. The baseline of estimation is the frequency comparison of bowel movement in children belonging into two groups: Lactobacillus reuteri treatment and placebo.

The secondary aim of the study is the assessment of frequency the additional symptoms connected with defecation disorders: such as: number of pain episodes during defecation, the intensity of pain, number of hard stools, number of fecal incontinence per week, number of macrogol (Forlax) pockets used.

The investigators believe that constipation treatment (laxatives- macrogol) with Lactobacillus reuteri has better efficacy that the same treatment without Lactobacillus reuteri in 3-7 years old children with medical history of chronic constipation.


Eligibility Criteria:
Inclusion Criteria:

* Children 3-7 years old
* Occurrence less than three bowel movement per week
* Medical history from at least two months\]
* Ineffective laxative treatment at least two months
* The parents approval for child participation in the study and for the treatment

Exclusion Criteria:

* Well-known, organic cause of constipation (i.e. hypothyroidism, Hirschprung disease, cystis fibrosis)
* Anatomic defects of the alimentary canal
* The surgery of the alimentary canal in the past
* Treatment of antibiotics/probiotics during last two weeks before start of the study
AKI Management Using Electronic Alerts

Acute kidney injury (AKI) is a common clinical event with severe consequences. In the United States alone, greater than one million hospitalized patients per year are diagnosed with AKI. It has been independently associated with prolonged hospital stays, 25-80% risk of in-hospital death, and future progression to chronic kidney disease. While there has been an increase in awareness about the prevalence and significance of AKI, studies have uncovered systematic failure in the management of AKI, largely relating to the failure of clinicians to recognize and manage the condition appropriately. This is where we can use electronic health records (EHRs) and electronic alerts (e-alerts) to our advantage. In this study, the investigators plan to use e-alerts integrated into a clinical decision support (CDS) system to improve the care of and outcomes of patients with AKI. The aims are to study the prevalence of AKI and its progression among hospitalized patients using an 'AKI sniffer' (an EHR based automated system) and to prospectively study if introducing a complex intervention (an e-alert combined with a clinical decision support system) will reduce progression of AKI in children. The investigators have developed an AKI care bundle which provides simple guidelines for management of AKI along with specific discharge instructions to improve follow up care. The primary outcome is AKI progression. Secondary outcomes include morbidity, mortality, length of hospital stay, need for renal replacement therapy, and recovery of renal function by time of hospital discharge. The investigators will also look at documentation of AKI and if these participants get appropriate follow up.


Eligibility Criteria:
Inclusion Criteria:

All patients between 6 months-18 years admitted to the surgical and medical floors of Seattle Children's Hospital

Exclusion Criteria:

1. History of chronic kidney disease stage 4 or worse (i.e., patients on chronic renal replacement therapy or glomerular filtration rate \< 30 mL/min/1.73 m2)
2. History of renal transplantation within the last 3 months
3. History of nephrectomy within last 3 months
4. Patients admitted to observation units
FORWARD PRO Study Interventional Post-market Study With the Evolut™ PRO System

Prospective, single-arm, multi-center, interventional post-market study. After signing informed consent, eligible subjects will be implanted with the CE marked Evolut™ PRO system.

The investigation purpose is to evaluate the acute and long term clinical performance and safety of Evolut™ PRO in a routine hospital setting in patients with symptomatic native aortic valve stenosis or a stenosed, insufficient, or combined surgical bioprosthetic valve failure necessitating valve replacement within the approved intended use in local geography.

Approximately 600 subjects implanted with the Evolut™ PRO at up to 40 sites in Europe. Other regions may be added depending on the regulatory status of the device.

Eligibility Criteria:
Inclusion Criteria:

* Symptomatic native aortic valve stenosis or a stenosed, insufficient, or combined surgical bioprosthetic valve failure necessitating valve replacement
* High or greater risk for surgical aortic valve replacement as estimated by the heart team OR, 75 years or older and at intermediate risk for surgical AVR (STS risk score ≥4% or with an estimated hospital mortality ≥4% as assessed by the heart team)
* Acceptable candidate for treatment with the Evolut™ PRO system in conformity with the Instructions for Use and the local regulations
* Able and willing to return to the implanting site at the following follow-up visits: 1-year, 3-year and 5-year
* Written informed consent obtained without assistance from a legal representative prior to enrollment in the study.

Exclusion Criteria:

* Known hypersensitivity or contraindication to aspirin, heparin (HIT/HITTS) and bivalirudin, ticlopidine, clopidogrel, Nitinol (Titanium or Nickel), or sensitivity to contrast media, which cannot be adequately premedicated
* Preexisting mechanical heart valve in aortic position
* Ongoing sepsis, including active endocarditis
* Anatomically not suitable for the Evolut™ PRO system
* Estimated life expectancy of less than 1 year
* Participating in another trial that may influence the outcome of this study
* Need for emergency surgery for any reason
* Inability to understand and respond to the quality of life questionnaire
Evaluation of Thermal-Aided Muscle Stimulation

An investigation into the relative effectiveness of thermal-aided muscle stimulation vs. body temperature muscle stimulation for eliciting muscle contraction in the quadriceps


Eligibility Criteria:
Inclusion Criteria:

* Subject does not meet any exclusion criteria

Exclusion Criteria:

* Age \< 18 years
* Subject is pregnant
* Subject has an implanted pacemaker/defibrillator
* Subject diagnosed with epilepsy
* Subject has implanted metallic femoral rods
* Subject is chair- or bed-bound
* Subject has neuromuscular disease or abnormalities
* Subject BMI \> 45
* Evidence of disease or condition that, in the opinion of the investigator, may compromise the conduct of or results of the study
Safety Study of Regimens of Sofosbuvir, GS-0938, and Ribavirin in Patients With Chronic Hepatitis C Infection

This study was designed to assess the safety and efficacy of multiple interferon-free treatment regimens of sofosbuvir (Sovaldi™; GS-7977; PSI-7977) and GS-0938 (PSI-352938) alone and in combination, with and without ribavirin (RBV). Each regimen was to be evaluated over 12 and 24 weeks to identify the optimal duration of therapy to maximize the benefit (sustained virologic response \[SVR\]) versus risk (safety and resistance).


Eligibility Criteria:
Inclusion Criteria:

* Chronic HCV-infection
* Naive to all HCV antiviral treatment
* Otherwise healthy patients

Exclusion Criteria:

* Positive test at Screening for HBsAg, anti-HBc IgM Ab, or anti-HIV Ab
* History of any other clinically significant chronic liver disease
* Medical history which the investigator considers the patient unsuitable for the study
Evaluation of AVE5026 as Compared to Enoxaparin for the Prevention of Venous Thromboembolism in Patients Undergoing Major Abdominal Surgery

The primary objective is to compare the efficacy and safety of once daily (q.d.) subcutaneous (s.c.) injections of Semuloparin sodium (AVE5026) with q.d. s.c. injections of Enoxaparin for the prevention of Venous Thromboembolic Events (VTE) in patients undergoing major abdominal surgery.

The secondary objectives are to evaluate the safety of Semuloparin sodium (AVE5026) and to document Semuloparin sodium (AVE5026) exposure in this population.

Randomization has to take place prior to the surgery.

The total duration of observation per participant is 35-42 days from surgery broken down as follows:

* 7 to 10-day double-blind treatment period;
* 28 to 35-day follow-up period.

Mandatory bilateral venography of the lower limbs has to be performed between 7 to 11 days after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patient undergoing major abdominal surgery (open surgery under general anesthesia lasting more than 45 minutes in the peritoneal and/or retroperitoneal space and/or pelvis).
* Patient \<60 years of age had to have one of the following additional risk factors for VTE:

  * History of VTE,
  * Obesity,
  * Chronic Heart failure,
  * Chronic Respiratory Failure,
  * Inflammatory Bowel Disease,
  * Cancer Surgery.

Exclusion Criteria:

* Any major orthopedic or general surgery in the 3 months prior to study start;
* Clinical signs or symptoms of DVT or PE within the last 12 months or known post phlebitic syndrome;
* Any contra-indications to the performance of venography;
* High risk of bleeding;
* Known hypersensitivity to heparin or Enoxaparin sodium;
* End stage renal disease or patient on dialysis.

The above information was not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.