cyrilzakka/clinical-trials huggingface dataset:
Clinical Investigation of AcrySof® IQ ReSTOR® +2.5 D Multifocal Intraocular Lens (IOL) Model SN6AD2 [SV25T0]

The purpose of this study is to compare the safety and efficacy of an investigational multifocal intraocular lens (IOL) to an FDA-approved monofocal IOL.

Participants 21 years and older in need of cataract extraction were consented and randomized in a 1:1 ratio at each investigative site to receive either the AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 \[SV25T0\] or the AcrySof® IQ Monofocal IOL Model SN60WF in both eyes. Each participant completed a preoperative examination of both eyes, implantation of IOL at the operative visit for each eye, and up to 7 postoperative visits, with monocular testing at Day 1-2, Day 7-14, and Day 30-60, and monocular and binocular testing at Day 120-180 following the second implantation. The first eye to be implanted was considered the primary eye. The second eye was implanted 7 and 30 days of the first. If the first eye was not implanted during surgery, the second eye was not eligible. If the second eye was not implanted during surgery, only the first eye was followed.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of bilateral cataracts
* Willing and able to complete all required postoperative visits
* Calculated lens power within the available supply range
* Planned cataract removal by phacoemulsification
* Potential postoperative visual acuity of 0.2 logMAR or better in both eyes
* Preoperative astigmatism less than 1.0 diopter
* Clear intraocular media other than cataract in study eyes
* Preoperative Best Corrected Distance Visual Acuity (BCDVA) worse than 0.2 logMAR
* Able to undergo second eye surgery between 7 days and 30 days of the first eye surgery
* Other protocol-defined inclusion criteria may apply

Exclusion Criteria:

* Previous refractive surgery
* Inflammation or edema of the cornea
* Optic nerve atrophy
* Pregnancy
* Current participation in another investigational drug or device study
* Other protocol-defined exclusion criteria may apply
Patient Recovery After Knee Replacement Surgery

This main objective of this feasibility study is to begin to quantify the relationship between patient activity levels following knee replacement surgery and outcomes.

This main objective of this feasibility study is to begin to quantify the relationship between patient activity levels following knee replacement surgery and outcomes.

Primary Aims The primary objective of this study is to compare step count and activity levels with key outcome measures - including pain scores and painkiller usage - to determine whether more active people have better recovery.

Eligibility Criteria:
Inclusion Criteria:

\* Adult

* Must be able to converse and understand English
* The participants must be selected for for single full knee replacement surgery at Milton Keynes University Hospital
* The participant must have access to a computer at home or be willing to plug a synchronization box into their broadband router
* The participants must have access to a valid email address or be able to create one for the purpose of this study (this may belong to a spouse, partner, friend or relative) or have access to a mobile phone able to receive SMS (text) messages

Exclusion Criteria:

* Insufficient language skills to understand the study procedures
* Cognitive impairment
* Medical conditions (e.g., severe neurological disorder, acute cancer, psychiatric disorder, acute infections) that prevent participation in the study
* Wheelchair user
* Significant lower limb arthritic joints
* Severe mobility limitation due to central or peripheral respiratory dysfunction
* Severe mobility limitation due to central or peripheral nervous system disorders
* Severe mobility limitation due to spinal condition
* Severe mobility limitation due to musculoskeletal disabilities
* Rheumatoid arthritis due to joint pain in both upper and lower limbs
* Amputee
* Dementia
Treatment of Knee Osteoarthritis With Autologous Mesenchymal Stromal Cell Product (RegStem)

Osteoarthritis (OA) is a common and incurable disease for the elderly in Taiwan, so it is an important mission to develop a new treatment for OA. Recently, cellular therapy is a new and popular medical treatment around the world, one of them is "Mesenchymal Stromal Cells (MSCs)". MSCs are found in many tissues of human body and play an important role for repairing, regeneration, anti-inflammatory and chondrogenesis. So, MSC product, RegStem, for osteoarthritis treatment becomes a developing target for new generation drugs.

This study is to isolate and expand MSCs(RegStem) from infrapatellar fat pad of subject. When the number of MSCs expands to 1×10\^8, cell will be cryopreserved in the liquid nitrogen tank until all release tests passed. On the distribution day, cell will be thawed and injected into joint cavity of patient (5×10\^7). Subjects will be monitored after MSC product infusion of seven days, one month, six months and one year. The monitoring items include the changes of knee (by appearance, X-ray and MRI of knee) and pain improvement (by questionnaire).


Eligibility Criteria:
Inclusion Criteria:

1. Subjects who understand and sign the informed consent form for this study
2. Grade 2\~3 osteoarthritis according to the Kellgren-Lawrence grading scale with one-month X-ray
3. Age is 50\~75 years old
4. Postmenopausal women
5. VAS scores in 50 to 90 mm

Exclusion Criteria:

1. Abnormal of liver and kidney: GOT and GPT \> 100 IU/L, BUN \>22 mg/dl and creatinine \> 1.2 mg/dl.
2. Positive serology for HIV, HTLV-1/2 and syphilis
3. Women who are pregnant or breast feeding
4. Serious pre-existing medical conditions: coagulation disorders, cardiovascular diseases (arrhythmias, myocardial infarction and surgery), renal diseases (chronic renal failure), liver diseases (cirrhosis), diabetes mellitus type I, cancer history.
5. Other joint diseases: knee deformity (knee varus greater than 10 degree or valgus greater than 20 degree), rheumatic arthritis, gouty arthritis, septic arthritis, serious meniscal tear, other autoimmune arthritis.
6. Skin inflammatory of knee
7. Knee pain caused by referred pain from spine disease or hip joint disease. Knee pain combined with pain from spine disease or hip disease.
8. Immunosuppressive state
9. Subjects who were injected with hyaluronic acid and PRP in the past 6 months
10. Body mass index (BMI) greater than 30
11. Have a history of allergic reaction of any medication
12. Participation in another clinical trial or treatment within 3 months
13. Other pathologic conditions or circumstances that difficult participation in this study according to PI's evaluations
Safety Study of 20,000 EU of Clinical Center Reference Endotoxin in Allergic Adults With and Without Mild Asthma

Endotoxin is a component of outdoor air pollution, an air contaminant found in a number of different workplaces, and is even found in homes. The endotoxin used for this study is obtained from the National Institutes of Health, and is called "Clinical Center Reference Endotoxin", or CCRE. The purpose of this Phase 1 research study is to identify a dose of inhaled endotoxin that is safe (does not cause prolonged cough, shortness of breath or other problems), but causes changes in your sputum cell samples that the scientists can measure. Phase 1 research studies like this one are not intended to be a treatment, but are a scientific investigation. Eventually, with these types of studies we will be able to examine why some people are more sensitive to endotoxin. Scientists at other universities have found that while most people do not have a considerable lung response to endotoxin at doses as high as 60,000 EU (endotoxin units), a few respond to as little as a total dose of 4500 EU. Our study is designed to identify if using a dose of 20,000 EU causes changes in the lung cells but does not cause symptoms in our study subjects. In our previous studies in our lab, using an endotoxin from another source, we have used higher doses (15,000 EUs) in subjects with asthma with no major problems, and we have used 10,000 EUs of CCRE in subjects with allergies and asthma without problems. We have used 20,000 EUs of CCRE in healthy individuals with no major problems.


Eligibility Criteria:
Inclusion Criteria:

* Mild allergic rhinitis
* Mild allergic asthma
* Normal lung function
* No other chronic illness

Exclusion Criteria:

* Use of inhaled or oral steroids
* Emergency treatment of asthma in last year
* Inhaled tobacco use
Influence of Nutrition and Sarcopenia on Esophageal Cancer Outcomes

Prospective multicenter longitudinal (observational) study recruiting from tertiary centers for the surgical management of esophageal cancer; Virginia Mason Medical Center (Seattle, USA) and St Mary's Hospital (Imperial College, London, UK). This is intended to be a pilot study.

Patients undergoing curative treatment for esophageal cancer will be recruited at the time of routine clinical assessment shortly following initial diagnosis and will undergo clinical and radiological evaluation at two study time points: (1) staging investigation (e.g. laparoscopy or endoscopy) and (2) definitive surgical resection. Study time points have been judiciously chosen to coincide with interventions that form part of patient's routine clinical care. It is intended that sampling will occur on the day of each intervention/surgery following a routine period of fasting.

Eligibility Criteria:
Inclusion Criteria:

* Patients with the following characteristics will be eligible for inclusion in this study:

  * Age 18-90 years
  * Newly diagnosed (prior to treatment) with esophageal and/or gastroesophageal junctional cancer (adeno- or squamous cell carcinoma)
  * Planning to undergo curative treatment, including surgical resection with or without neoadjuvant therapy

Exclusion Criteria:

* Patients with the following characteristics will not be eligible for inclusion in this study:

  * Pregnant females
  * Without malignant esophageal disease
  * Inability or unwillingness to provided informed written consent
Comparison Between Amoxycillin/Clavulanic Acid and Oxacillin/Ceftriaxone for Community Acquired-pneumonia

Objective: To compare the clinical effectiveness and hospital costs, the initial empirical treatment, Oxacillin / Ceftriaxone and Amoxicillin / Clavulanate in children with Community Acquired Pneumonia (CAP) severe.

Methods: Clinical prospective randomized study in children aged two months to five years of age with a diagnosis of severe CAP, according to criteria of World Health Organization (WHO), admitted to the Pediatrics Ward of the Hospital of the Medical School of Botucatu- UNESP. We excluded children with comorbid disorders (primary and secondary immunodeficiency) with acute or chronic kidney disease, referred patients receiving antibiotics proposal and history of allergy to antibiotics proposed. We included 104 children who were randomized into two groups to receive: Oxacillin / Ceftriaxone IV (GCO, n = 48) and Amoxicillin / Clavulanate IV (GAA, n = 56). Patients of the GAA, after clinical improvement, has been receiving the same oral antibiotic, and maintaining clinical stability, were discharged from hospital, the GOC received any IV treatment. The outcomes analyzed were time to clinical improvement (fever and tachypnea), duration of oxygen therapy, hospitalization time, need to expand the antimicrobial spectrum progression to pleural effusion / empyema (DP / E) and hospital costs. Treatment failure was determined by the need to expand the antimicrobial spectrum after 48 hours of hospitalization.

eligibility: Children aged two months to five years with diagnosis of severe community acquired pneumonia, requiring hospitalization.

Outcomes measures: time to clinical improvement (respiratory rate and fever), duration of oxygen therapy, length of stay in the Division of Pediatrics, evolution with clinical complications, need for broadening the spectrum antimicrobials.

Eligibility Criteria:
Inclusion Criteria:

* children aged from 2 months to 5 years
* children diagnosed with severe community-acquired pneumonia, who require hospitalization.

Exclusion Criteria:

* chronical diseases
* severe comorbidities
* children admitted at PICU
Protection From Gender-based Violence in Cote d'Ivoire

There is some evidence that suggests that economic empowerment and challenging gender inequalities and prevailing ideas on masculinities will lead to a decrease in levels of partner violence. However, there is still a gap in our understanding of what elements are required. This project evaluates whether participation within a savings group and a discussion group confronting gender norms will lead to an increase in women's individual agency and decision-making ability that will improve their economic independence and decrease intimate partner violence in their homes.


Eligibility Criteria:
Inclusion Criteria:

* No Prior experiences with microcredit programs
* 18+
* Source of stable income

Exclusion Criteria:

* 18+
* prior experience with microcredit
Turkish Montreal Children's Hospital Feeding Scale

The purpose of this study is to test the reliability and validity of the Turkish Montreal Children's Hospital Feeding Scale.

The purpose of this study is to test the reliability and validity of the Turkish Montreal Children's Hospital Feeding Scale. The internal consistency, test-retest reliability, and criterion validity of Turkish Montreal Children's Hospital Feeding Scale will be investigated. The internal consistency will be assessed using Cronbach's alpha. Intraclass correlation coefficient (ICC) value with 95 % confidence intervals will be calculated for test-retest reliability. The criterion validity of the scale will be determined by assessing the correlation between the Turkish Montreal Children's Hospital Feeding Scale and Behavioral Pediatrics Feeding Assessment Scale.

Eligibility Criteria:
Inclusion Criteria:

* Children with cerebral palsy
* Children with typical development
* Aged between 18 months- 6 years

Exclusion Criteria:

* Who aged under the age of 18 months and above the age of 6 years.
Coordinated HEalthcare for Complex Kids

The University of Illinois Health and Health Sciences System (UI Health) developed an integrated care management quality improvement model designed to provide comprehensive care coordination for Medicaid insured minority children and young adults with chronic health conditions living in Chicago. This program, called CHECK (Coordinated HEalthcare for Complex Kids), targeted children and young adults with chronic disease.

The University of Illinois Health and Health Sciences System (UI Health) developed an integrated care management quality improvement model designed to provide comprehensive care coordination for Medicaid insured minority children and young adults with chronic health conditions living in Chicago. This program, called CHECK (Coordinated HEalthcare for Complex Kids), was funded by a Centers for Medicare and Medicaid Services Innovation (CMMI) Award. The CHECK model took a broad approach to health promotion by addressing social determinants of health, caregiver wellness and mental health needs; in addition to disease management. The program targeted children and young adults from birth to age 25 with diagnoses of asthma, diabetes, sickle cell disease, seizure disorder or prematurity. All participants were enrolled in either the traditional (fee-for-service) state Medicaid program or a Medicaid Managed Care Organization (MCO) in Illinois. CHECK provided access to care coordination delivered by community health workers; mental health services and health education.

CHECK was designed as a demonstration program and participants were enrolled passively over time and received different services depending on their level of risk and need. One primary aim of the CHECK program was to decrease Medicaid expenditures over a three-year period by decreasing unnecessary emergency department visits and hospitalizations.

Though CHECK was designed as a care delivery demonstration program, in April, 2016 we had the opportunity to prospectively randomize 6,259 participants who met eligibility criteria for CHECK, for the purpose of program evaluation.

Eligibility Criteria:
Inclusion Criteria:

* Age 0-25 years;
* Documentation of asthma,
* Diabetes mellitus (type 1 or 2), sickle cell disease,
* Seizure disorder or
* Prematurity; 3)
* Enrolled in Medicaid; and
* Ride in Cook County, Illinois.

Exclusion criteria:

• None
The Role of Endogenous GLP-1 (Glycolipoprotein) in Regulating Glucose Stimulated Brain Activity

Our objective is to investigate neuro-anatomical correlates of the regulation of energy intake by means of functional MRI. Administration of glucose with and without lactisole and exendin as well as fructose is followed by functional brain MRI, and findings are correlated with serum GLP-1 levels as an endogenous satiety signal in humans.


Eligibility Criteria:
Inclusion Criteria:

* right-handed healthy males, no drugs, non-smoking

Exclusion Criteria:

* drug abuse, smoker, left-handed, claustrophobia
Hepatic Metabolism of Galactose and the Galactose Analog FDGal in Patients With Liver Disease and Healthy Subjects

The elimination of the carbohydrate galactose is used in daily clinical work with liver patients as a quantitative measure of metabolic liver function, as the liver test "The Galactose Elimination Capacity", GEC. We are working to develop a PET/CT scanning procedure for providing 3D images of the hepatic galactose elimination and measurement of regional values. This may be used for example for planning resection or stereotactic radiotherapy of a patient with malignant tumor in the liver. Will the patient be able to tolerate removal of the necessary part of the liver? We will include 10 patients with liver cirrhosis and 6 healthy human subjects. Direct measurements of the hepatic galactose elimination (successive constant iv infusions of galactose in increasing doses with measurements of blood concentrations of galactose in blood from an artery and a liver vein, and measurements of liver blood flow by indocyanine green, Ficks principle) are compared with PET/CT measurements after iv injection of a 18F-labelled galactose analog, FDGal.

Based on previous studies in pigs, we perform detailed calculations of the hepatic galactose elimination kinetics by the two methods, including estimation of a factor ("lumped constant") for recalculating PET/CT data to data for natural galactose.

Besides possible practical clinical importance, the project elucidates basic problems concerning liver metabolism using PET.


Eligibility Criteria:
Inclusion Criteria:

* liver cirrhosis

Exclusion Criteria:

* hepatic encephalopathy
* pregnancy
Study to Determine if Atorvastatin Reduces Size and Stiffness of Muscle in the Left Ventricle of the Heart

The purpose of this study is to determine if a drug called atorvastatin will reduce the size and stiffness of the muscle in the left ventricle of the heart.

Hypertrophic cardiomyopathy (HCM) is a primary disorder of the heart characterized by a thickened, fibrotic myocardium, with or without a dynamic left ventricular outflow tract gradient. It is a common heritable cardiovascular disease, with a population prevalence of 0.1% to 0.2%. Symptoms of congestive heart failure are extremely common in patients with HCM. Progression to disabling and debilitating symptoms \[New York Heart Association (NYHA) class III and IV\] is relatively common, occurring in 15% to 20% of unselected populations. The rate of progression to NYHA class III or IV or death from heart failure or stroke is high, with a relative risk 2.7. Management of symptoms can be very challenging, involve multiple medications, and 5% of patients may develop drug refractory heart failure, requiring invasive intervention. HCM is the most common cause of sudden death among young competitive athletes. Ventricular tachyarrhythmias appear to be the primary mechanism; however, other arrhythmias involved include asystole, rapid atrial fibrillation, and electrical mechanical dissociation. Patients may develop progressive myocardial wall thinning, a reduction in systolic performance, and an increase in left ventricular dimensions. Progressive wall thinning may be especially common in patients with initially severe hypertrophy. There is no cure for this condition. There is now evidence from both animal and human studies of a treatment that promises to reverse hypertrophy - HMG CoA reductase inhibitors. Clearly, studies of treatments that might cause regression of hypertrophy are timely and important.

Eligibility Criteria:
Inclusion Criteria:

* 18 years and over with HCM in the absence of another cardiac or systemic disease capable of producing a prespecified wall thickening

Exclusion Criteria:

* Required use of statin therapy or intolerance
* A clinical diagnosis of hypertension
* Indication for statin therapy for primary or secondary prevention of coronary artery disease
* Current or anticipated indication in ≤ 1 year for implantable cardioverter defibrillators or other metallic devices preventing cardiac magnetic resonance imaging (MRI).
Acute Effects of Intermittent Hypoxia-Hyperoxia in Older Adults

The supply of oxygen is essential for energy production, recovery from efforts, and human life. Intermittent Hypoxia-Hyperoxia Exposure (IHHE) is a novel technique in which the subject is exposed to a respiratory environment with reduced oxygen fraction, controlled through a specific software, using a facial mask and a hypoxic generation device. The objective of this study is to determine if there is a relationship between intermittent hypoxia-hyperoxia exposure and cardiorespiratory condition, blood pressure, and arterial oxygen saturation.

According to our hypothesis, acute IHHE in elderly adults may influence cardiorespiratory condition, blood pressure, and arterial oxygen saturation.

The study will be conducted as a randomized clinical trial. The subjects will be divided into two groups: the experimental group will undergo an IHHE session, breathing air with an oxygen concentration (FiO2) ranging from 10-14% for 1-5 minutes, with 1-3 minutes of rest in hyperoxia (FiO2 30-40%) for a total of 4-8 cycles, based on their acute response to hypoxia. The placebo group will undergo a 5-cycle protocol with an FiO2 of 21%.


Eligibility Criteria:
Inclusion Criteria:

* Being over 60 years old.
* Having no previous experience in hypoxic training.
* Engaging in less than 150 minutes of physical activity per week.

Exclusion Criteria:

* Having any pathology that prevents the subject from being independent in terms of walking and functionality.
* Subjects with impaired cognitive abilities.
* Subjects with pulmonary hypertension, decompensated heart or respiratory disease.
* To have or have had cancer