cyrilzakka/clinical-trials huggingface dataset:
Randomized Comparison of the Abbott WHITESTAR Signature System With Ellips Tranversal Ultrasound vs. the Alcon Infiniti With the Ozil Torsional Handpiece in Phacoemulsification: A Contralaterally-Controlled Trial

The purpose of this study is to look at the outcomes of your vision after your cataract surgery based on two different types of equipment that will be used during your surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients at least 21 scheduled to undergo bilateral phacoemulsification with implantation of multifocal IOLs.
* Both eyes must have similar degrees of cataract and astigmatism (topographic cylinder difference of \<2.00D as well as similar globe axial length as measured by the IOL Master of \<0.5mm).
* Visual potential of UCVA 20/25/ or better.
* Clear intraocular media other than cataract.

Exclusion Criteria:

* Clinically relevant differences between eyes in ocular disease or pathology.
* Presence of glaucoma, macular disease, or foveal disease to an asymmetrical degree.
* Asymmetrical use of ocular medications.
18 Week Study Evaluating Safety and Efficacy of Olmesartan, Amlodipine, and Hydrochlorothiazide, in Type 2 Diabetics

To determine if olmesartan plus amlodipine combination therapy alone and with hydrochlorothiazide will be safe and effective to reduce high blood pressure in hypertensive, type 2 diabetic subjects.

This is a single group study in which participants were titrated to the next of 6 regimens if blood pressure (BP) goals were not met.

Eligibility Criteria:
Inclusion Criteria:

* Males or females aged 18 to 80 years.
* Diagnosis of type 2 diabetes mellitus and on a stable regimen of any oral antidiabetic agent(s) for at least 3 months, with or without adjunctive use of Byetta (exenatide);

Note: Subjects diagnosed with type 2 diabetes mellitus who were not on oral antidiabetic agents may have been enrolled if they had a documented history of type 2 diabetes by American Diabetes Association criteria, including the specific plasma glucose results listed below:

* Fasting plasma glucose \>=126 mg/dL (7.0 mmol/L); or
* Symptoms of hyperglycemia and a casual (any time of day without regard to time since last meal) plasma glucose \>=200 mg/dL (11.1 mmol/L). The classic symptoms of hyperglycemia were considered to include polyuria, polydipsia, and unexplained weight loss; or
* Two-hour plasma glucose \>=200 mg/dL (11.1 mmol/L) during an oral glucose tolerance test;
* Newly diagnosed hypertension or uncontrolled hypertension (defined as SBP \>130 mmHg and/or DBP \>80 mmHg) on current antihypertensive monotherapy or combination therapy.
* Subjects must fulfill mean seated office blood pressure parameters at two consecutive, qualifying visits during the placebo run-in phase, and, subsequently, daytime ambulatory blood pressure monitoring (ABPM) criteria.
* Females should not be pregnant or lactating and, if applicable, using adequate contraception.

Exclusion Criteria:

* Subjects with uncontrolled hypertension taking multiple antihypertensive therapies (at the discretion of the investigator).
* Type 2 diabetes mellitus with a glycosylated hemoglobin A1c (HbA1c) \>=9.0% at screening;
* Subjects with type 1 or type 2 diabetes mellitus requiring insulin.
* Subjects with any serious disorder which may limit the ability to evaluate the safety and efficacy of study medication, or subjects with secondary hypertension.
A Study to Learn About the Treatment LTP001 in Healthy Participants (Part A) and in Participants With PAH (Part B)

A study to learn about the treatment LTP001 in healthy participants (Part A) and in participants with PAH (Part B)

The CLTP001A12202 study will explore the safety, tolerability, and pharmacokinetics of LTP001 in healthy volunteers (Part A) and will evaluate the safety and efficacy (Part B) followed by safety extension in participants with pulmonary arterial hypertension.

Eligibility Criteria:
Part A Inclusion Criteria:

* Healthy males and non-child-bearing potential females

Part A Exclusion Criteria:

* Clinically significant ECG or cardiac abnormalities, any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the participant in the study Other protocol-defined inclusion/exclusion criteria may apply.

Part B Inclusion Criteria:

-Confirmed diagnosis of PAH, pre-randomization PVR ≥400 dyn.sec.cm-5, treatment with stable doses of standard-of-care PAH therapies, 6-minute walk distance ≥ 150 m and ≤450 m.

Part B Exclusion Criteria:

Any surgical or medical condition which may place the participant at higher risk from his/her participation in the study Women of child-bearing potential unless they are using highly effective methods of contraception Sexually active males unwilling to use a condom during intercourse while taking study treatment and for 24 hours after stopping study treatment.

History of hypersensitivity to any of the study treatments or excipients

Other protocol-defined inclusion / exclusion criteria may apply
Bladder Diary for Female Storage LUTS

Storage urinary symptoms are the most complained of lower urinary tract symptoms (LUTS) and need further classification. This original study aims to derive a novel classification algorism for female storage LUTS according to a 3-day bladder diary (BD). Further feasibility of the application was also evaluated.

Between July 2009 and December 2021, all women with storage lower urinary tract symptoms (LUTS) who visited the urogynecological department of a medical center were included. Women without complete data of a 3-day bladder diary (BD) were excluded from this study. The women were allocated into 12 groups according to the study flowchart based on their LUTS, including urinary urgency, stress urinary incontinence, urgency urinary incontinence, nocturia and frequency. MedCalc software was used for statistical analysis. Analysis of variance (ANOVA) was applied, and a P-value of less than 0.05 was considered as statistically significant. Post-hot analyses by the Student-Newman-Keuls test were performed only in those comparisons with p \< 0.05 after ANOVA.

Eligibility Criteria:
Inclusion Criteria:

* Women more than 20-years-old
* With storage lower urinary tract symptoms
* Finished a 3-day bladder diary

Exclusion Criteria:

* No lower urinary tract symptoms
* Pregnant
* Incomplete data of bladder diary
A Prospective, Randomized Trial of Histoacryl Injection Versus Thrombin in the Control of Acute Gastric Variceal Bleeding

Though histoacryl injection is now regarded as treatment of choice in the control of gastric variceal hemorrhage, it may be associated with a lot of complications such as ulcers, ulcer bleeding, bacterial infections, distant site thrombosis and cerebral vascular accident. On the other hand, thrombin has been shown to be effective in acute hemostasis of bleeding gastric varices, ranging from 70% to 100% has been recorded. The rebleeding rates were between 7% and 50%. Moreover, the benefits of thrombin injection include safety, without inducing ulcers or ulcer bleeding. No incidence of distant thrombosis has ever been reported.

Previous studies have proven that the use of cyanoacrylate glue injection was superior to EIS or EVL in arresting acute gastric variceal bleeding. Endoscopic obturation with glue injection has gained worldwide popularity except the United States. The hemostatic rates of glue injection ranged from 87% to 100%, with rebleeding rates about 7% to 71%.

Though histoacryl injection is now regarded as treatment of choice in the control of gastric variceal hemorrhage, it may be associated with a lot of complications such as ulcers, ulcer bleeding, bacterial infections, distant site thrombosis and cerebral vascular accident. On the other hand, thrombin has been shown to be effective in acute hemostasis of bleeding gastric varices, ranging from 70% to 100% has been recorded. The rebleeding rates were between 7% and 50%. Moreover, the benefits of thrombin injection include safety, without inducing ulcers or ulcer bleeding. No incidence of distant thrombosis has ever been reported. The mechanism of hemostasis induced by thrombin is through the conversion of fibrinogen to fibrin and enhancement of platelets aggregation. This trial aimed to compare the relative efficacy and safety between histoacryl injection and thrombin injection in the prevention of gastric variceal rebleeding.

Eligibility Criteria:
Inclusion Criteria:

* 1.The etiology of portal hypertension is cirrhosis. 2.Age ranges between 20-80 y/o. 3.Patients presenting with history of gastric variceal bleeding or acute gastric variceal bleeding proven by emergency endoscopy

Exclusion Criteria:

* 1) association with severe systemic illness, such as sepsis, CVA, COPD, advanced carcinoma, hepatocellular carcinoma (Barcelona Club Liver Cancer class C or D) 2) presence of massive ascites 3), serum creatinine \>3mg/dl, hepatic encephalopathy \> stage II, 4) serum bilirubin \> 10mg/dl 5) life expectancy less than 24 hours 6) Child-Pugh's scores \> 13 7) pregnancy 8) has ulcers on gastric varices 9) Uncooperative
Safety and Efficacy Study of the Nile PAX Drug-Eluting Coronary Bifurcation Stent

The purpose of this trial is to assess the safety and efficacy of the Nile PAX® Drug Eluting Coronary Bifurcation Stent System for the treatment of single de novo bifurcation lesions in native coronary arteries with a main branch reference vessel diameter of 2.5-3.5 mm and side branch reference vessel diameter of 2.0-3.0 mm.

The BIPAX clinical trial is a prospective, non-randomized, multicenter, clinical trial evaluating the investigational coronary bifurcation device Nile PAX® in patients with main branch reference vessel diameters \>= 2.5 mm and \<= 3.5 mm, side branch reference vessel diameters \>= 2.0 and \<= 3.0 and lesion length \<= 14 mm. The trial allows the treatment of a single de novo bifurcation lesion in native coronary arteries following the provisional T-stenting technique with mandatory pre-dilatation of the main branch. In case the side branch requires a stent the treatment will be completed when possible with a Delta PAX® Drug Eluting Side Branch Stent.

The BIPAX clinical trial will enroll 100 patients. All patients will receive Quantitative Coronary Angiography (QCA) after stent implantation and at 9 months follow-up. All patients will have a clinical follow-up at 1, 6, 9 and 12 months and subsequently every year up to 5 years.

Eligibility Criteria:
Inclusion Criteria:

* De novo bifurcation lesions following the Medina classification except (0,0,1).
* Maximum one bifurcation lesion per patient.
* Single bifurcation lesion per vessel.
* The patient is at least 18 years of age. The patient has clinical evidence of ischemic heart disease, stable or unstable angina, silent ischemia, or a positive functional trial.
* The patient is an acceptable candidate for percutaneous transluminal coronary angioplasty (PTCA), stenting, and emergent coronary artery bypass graft (CABG) surgery.
* The patient or patient's legal representative has been informed of the nature of the trial and agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board/Ethics Committee (IRB/EC) of the respective clinical site.
* The patient agrees to return to the same research facility for all required post-procedure follow-up visits.

Exclusion Criteria:

* De novo bifurcation lesion Medina (0,0,1).
* Left main bifurcation.
* Heavily calcified lesions.
* Severe tortuous lesions.
* Documented left ventricular ejection fraction (LVEF) \< 30% at most recent evaluation.
* Women of childbearing potential.
* Chronic total occlusion (CTO).
* Previous PCI of the target lesion.
* Second lesion requiring treatment in target vessel.
* Second bifurcation lesion requiring treatment.
* Currently participating in an investigational drug or another device trial that has not completed the primary endpoint or that clinically interferes with the current trial endpoints; or requires coronary angiography, IVUS or other coronary artery imaging procedures.
Comparison of NaF PET-CT and Diffusion MRI in the Diagnosis of Bone Metastases (IMMETAOS)

Prospective, monocentric, comparative, non randomised

Primary objective :

- to compare the diagnostic accuracy of sodium fluoride PET-CT and MRI using the conventional block and diffusion sequence in the search for bone metastases

Secondary objectives :

* compare accuracy of MRI diffusion and conventional MRI
* explore the evolution of the results of the different types of imaging over time or under treatment for patients with repeated examinations at 6 months

Prospective, monocentric, comparative, non randomised.

Organization of NaF PET-CT and MRI on the same day or within a 10 days period.

At 6 months :

* repeat both exams systematically if one of the initial tests showed a suspicious or doubtful abnormality
* final diagnosis by a committee of practitioners using the whole patient's file

Scheduled Project inclusion duration of 36 months (possible adaptation of duration in order to obtain the number of required patients)

Eligibility Criteria:
Inclusion Criteria:

* Man or woman over 18 years
* Osteophilic cancer (breast, prostate, lung, kidney, thyroid) proved by pathological material, with a high probability of bone metastases
* With an indication to a bone examination: systematic search for metastasis for the staging or due to clinical or laboratory suspicion of bone metastasis
* Registered in a social security health scheme
* Written informed consent obtained

Exclusion Criteria:

* Classical contra-indications for PET CT (suspected pregnancy) or MRI (pacemaker, ferromagnetic material); for patients with a possibility of pregnancy (women of childbearing age without contraception and second part of the menstrual cycle, or the slightest suspicion), verification of the absence of pregnancy will be made by the beta HCG dosage before injection of radioactive tracer
* Uncontrollable claustrophobia with treatment anxiolytic
* Antitumor treatment started between the two imaging tests
* Imaging or treatment needed in emergency, if both tests are not performable in time required for the care
* Inaugural neurological complication
* Patient unable to undergo biomedical research (under guardianship or deprived of liberty)
Effect of Diet and Physical Activity on Adipokines

The prevalence of metabolic syndrome (MetS) in young population continues to rise. Obesity is a chronic inflammatory disorder in which leptin, adiponectin and C reactive protein (CRP) play an important role. This study aimed to determine whether these adipokines are significant markers in defining MetS in pediatric population and to assess the effect of hypocaloric diet and physical activity on serum concentrations of adiponectine, leptin, and high sensitivity CRP (hs-CRP).

The idea that adipose tissue is just a form of energy storage has changed dramatically in recent years. Currently, adipose tissue is considered to be a true endocrine gland that fulfills multiple roles in regulating different biological functions. Communication between adipose tissue and the rest of the systems is accomplished through bioactive mediators (adipokines) Adipokines control energy homeostasis and are involved in metabolic, endocrine and immunological processes.The prevalence of metabolic syndrome (MetS) in young population continues to rise. Obesity is a chronic inflammatory disorder in which leptin, adiponectin and C reactive protein (CRP) play an important role. This study aimed to determine whether these adipokines are significant markers in defining MetS in pediatric population and to assess the effect of hypocaloric diet and physical activity on serum concentrations of adiponectine, leptin, and high sensitivity CRP (hs-CRP).

The investigators tested the hypothesis that long-term lifestyle changes and moderate weight loss would reduce the plasma concentrations of adipokines involved in inflammation, angiogenesis, and chemotaxis and would increase adiponectin concentrations.

Material and methods:

A prospective study was conducted over a period of 1 year, between January 2016 and December 2016, on 66 cases of obesity in children diagnosed at the Louis Ţurcanu Emergency Hospital for Children Timisoara. The patients diagnosed with MetS were put on diet and physical exercise for 3 months.

Eligibility Criteria:
Inclusion Criteria:

* obese children (BMI\> 95th percentile)

Exclusion Criteria:

* obesity caused by endocrine disease, syndromic obesity, systemic disease or acute illness.
Prospective Study Evaluating the Effect of Repository Corticotropin in the Treatment of Various Nephrotic Syndromes

To determine if H.P. Acthar Gel (repository corticotrophin) has the same anti-proteinuric effects seen with the synthetic ACTH analogue in Europe.

Synthetic ACTH (Synacthen Depot) has been used in the treatment of Nephrotic Syndrome in Europe. It has been proven effective in treating idiopathic membranous nephropathy and other various diagnoses involving the kidneys. However, Synacthen is not available in the United States. The only preparation available is the H.P. Acthar Gel (repository corticotrophin) which has been widely used in the treatment of infantile spasms and has been available longer than Synacthen. Therefore, we are conducting this study to determine if H.P. Acthar Gel (repository corticotrophin) is as effective in reducing protein in the urine as seen in synthetic ACTH in Europe.

Eligibility Criteria:
Inclusion Criteria:

* Nephrotic Syndrome with a minimal of 3.5grams of protein per 24 hr period, measured via either 24hr urine collection or spot protein to creatinine ratio.
* Males and post-menopausal, surgically sterile, or non-lactating and non-pregnant females using adequate contraception
* Biopsy proven diagnosis of nephrotic syndrome due to Lupus glomerulonephritis, Membranous nephropathy, Focal segmental glomerulosclerosis, Minimal Change disease, Diabetic nephropathy (type 2)or IgA nephropathy.
* Greater than 18 years of age
* Willing and able to give informed consent
* Diabetics are on insulin or willing to start insulin during the study

Exclusion Criteria:

* Previous intolerance to native ACTH or proteins of porcine origin
* History of scleroderma, osteoporosis, systemic fungal infections, ocular herpes simplex, recent surgery, history of or the presence of peptic ulcer, primary adrenocortical insufficiency or adrenocortical hyperfunction.
* Expected to begin renal replacement therapy or receive a transplant within the next year.
* Recent cardiovascular event within 3 months of screening including: Myocardial Infarction, CVA, TIA, New York Heart Association Functional Class III or IV failure, Obstructive valvular heart disease, or hypertrophic cardiomyopathy, second or third degree atrioventricular block not successfully treated with a pacemaker.
* History of HIV
* Know peptic ulcer disease.
* SBP\> 160 or DBP \> 100 at time of enrollment
* New diagnosis of cancer or recurrent cancer within 2 years of screening
* History of alcohol or drug abuse within 12 months of study entry.
* Receipt of any investigational drug within 30 days of enrollment.
* Anticipated major surgery during trial period
* Psychiatric disorder that interferes with the patient's ability to comply with the protocol.
* Inability to cooperate with study personnel or history of noncompliance to medical management
* Active infection within 1 month of screening
* Poorly controlled diabetes with an HbA1C \> 10%
* Type 1 diabetes mellitus
Bifidobacterium Lactis BB12 and Xylitol Delivered With a Novel Slow-release Pacifier

Aims:

1. To develop a food supplement containing a health-promoting probiotic bacteria (B. lactis BB12) and xylitol to be administered with a novel soft, possibly occlusion-friendly pacifier.
2. Test in a clinical study how feasible the method is and to study how the intervention affects caries occurrence.

Main hypothesis:

The administration of B. lactis BB12 and xylitol affects beneficially the dental health of the child.

Xylitol is known to reduce counts of mutans streptococci (ms) as well as mother-child transmission of ms. Possibly xylitol delivered to infants could positively influence colonization/metabolism of ms. By combining in a food supplement xylitol and B. lactis BB12 (a well known probiotic bacteria) we may be able to positively affect both gut and oral colonization, reflected in both dental and general health (solid data available on the latter aim). Though B. lactis is in wide use in baby formulas and in in vitro tests it apparently is safe for the teeth, no clinical studies have looked at effects of its administration to infants on oral health. Our study aims to look at caries occurrence in infants who have received the xylitol + BB12 food supplement with a pacifier.

Recruiting of subjects to the study is completed.

Eligibility Criteria:
Inclusion Criteria:

* The infant is healthy
* The family agrees to use the novel slow-release pacifier
* The infant starts to use the pacifier before the age of 3 months

Exclusion Criteria:

* The child is not healthy
A Very High Fiber Diet Versus a Low-carbohydrate Diet for Weight Loss

Using a 2x2 complete factorial design, approximately 140 obese men and women who may or may not have type 2 diabetes will be randomized to one of two conditions (70 in each condition): (a) a high fiber diet, or (b) a low-carbohydrate diet. Participants will be instructed to follow their assigned diets for 1 year. Outcome measures of interest will include participants' BMI, waist circumference, blood lipids (total, HDL, and LDL cholesterol, and triglycerides), C-reactive protein, and gastrointestinal peptides. Participants will be recruited from the Loma Linda and San Bernardino city area in southern California.


Eligibility Criteria:
Inclusion Criteria:

* BMI 30.0-42.0 kg/m2
* English-speaking

Exclusion Criteria:

* Pregnancy
* Lactation
* Acute or chronic infection
* Type 1 diabetes
* Participation in another trial
* Active cancers
* Currently using Byetta
* Currently on weight loss medication
* Weight loss of more than 4 lbs. within the last 3 months
* Vegan
* Active eating disorder
* Gastrointestinal problems that may be worsened by a high fiber intake