cyrilzakka/clinical-trials huggingface dataset:
Native Hawaiian Diabetes Intervention Program

The Native Hawaiian Diabetes Intervention Program is a project focused on determining whether a cultural-based, healthy lifestyles program with family support will have a positive effect on lifestyle behaviors and psychosocial and clinical outcomes. A culturally sensitive, lifestyle intervention program was administered via community peer educators to a population of Native Hawaiians with or at risk for diabetes. The effect of this intervention program on selected outcomes is being compared to a ''standard'' program given to a similar population in a second Native Hawaiian community.


Eligibility Criteria:
Inclusion Criteria:

* Participant must be a Native Hawaiian adult 30 years of age or older residing in the research community and have diabetes or at-risk for diabetes.
* Family support member must be 18 years or older and live in the study community and be willing to go through the entire program with the participant as their support person.
* Physician clearance to participate in the program.

Exclusion Criteria:

* Pregnancy
Safety and Efficacy of Nateglinide in Patients With Type 2 Diabetes Already Taking Insulin Glargine, Metformin and/or Pioglitazone or Rosiglitazone

This study will assess the safety and efficacy of adding nateglinide to treatment with basal insulin glargine, metformin and/or thiazolidinedione (pioglitazone or rosiglitazone), for patients with type 2 diabetes who are not achieving glycemic control with glargine, metformin and/or thiazolidinedione only.


Eligibility Criteria:
Inclusion Criteria:

* Male/female, age 18-78 inclusive
* Type 2 diabetes, taking glargine, metformin and/or thiazolidinedione for 3 months prior to screening, stable doses for 2 months prior to screening
* HbA1c 7.0-8.5% inclusive
* Fasting plasma glucose \<240 mg/dL at screening
* Body Mass Index 22-41 kg/m2

Exclusion Criteria:

* Pregnant or nursing
* Other investigational drugs within 30 days of screening
* Treatment with other anti-diabetic medications other than metformin, glargine and/or thiazolidinedione
* History of type 1 diabetes
* Abnormal kidney function
* History of acute diabetic complications
* Congestive heart failure requiring treatment
* Myocardial infarction, coronary artery surgery, stroke within 6 months of screening
* Liver disease, liver enzymes more than 3 times upper limit of normal
* Fasting triglycerides \>700 mg/dL within past 12 weeks
* Acute infections or other conditions that may affect blood sugar or may interfere with interpretation of study data
* Treatment with corticosteroids
* Blood donation within past 12 weeks

Other protocol-defined inclusion/exclusion criterial may apply.
Muscle-Sparing Effect Of Human Chorionic Gonadotropin (hCG) During a Very Low Calorie Diet (VLCD)

Subjects are female patients, randomized to HCG group or placebo group, during a prospective trial, in order to determine the significance, if any, of HCG on maintaining muscle mass during a very low calorie diet in order to demonstrate the potential significance of HCG administration on preserving lean body mass while losing weight.

Four-week clinical trials were conducted on 59 females between the ages of 20 and 55, over an 18 month period. Exclusion criteria included thyroid conditions or prior significant medical history. Patients were randomized to receive daily subcutaneous injections of either hCG (200-300IU) or saline (placebo). All were placed on a VLCD resembling a protein-sparing modified fast. The caloric intake was between 500 and 600 calories, with 50% protein and 50% complex carbohydrates consisting mostly of fruits and vegetables. Measured parameters: weight, body composition via bio-impedance, blood pressure, and blood labs. A subset also underwent weekly electrocardiograms (EKG).

Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index (BMI) greater than 30,
* Female,
* good health

Exclusion Criteria:

* complex medical history,
* thyroid disease,
* BMI less than 30,
* psychological instability or history of eating disorder
Femtosecond Laser Versus Microkeratome in Creating Corneal Flaps in LASIK

Since the cornea is the main responsible for the refraction of the eye, as its refractive power is greater than 70% of the total refraction of the eye, so modification of its refractive properties are used to change the optical system of the eye. Hence, laser-assisted in situ keratomileusis has become the most commonly procedure used to correct the refractive errors of the eye. The most important step in laser-assisted in situ keratomileusis is the creation of the corneal flap, which its thickness may judge the whole outcome of the surgery . So trying to minimize the variation in the thickness of the resultant flap in comparison to what planned flap thickness preoperatively become our target.

As laser-assisted in situ keratomileusis procedure started to use automated microkeratomes in creating corneal flaps since 1989, and science go on until United states Food and Drug Administration approved the IntraLase laser for flap creation in January 2000 femtosecond lasers work by emitting light pulses of short duration (10-15 s) at 1053 nm wavelength that cause photodisruption of the tissue with minimum collateral damage . This enables no blade incisions to be performed within the tissue at various patterns and depth with high precision.

Aim of the work To evaluate and compare the variation in corneal flap thickness created from use of a femtosecond laser and a MORIA microkeratome when making a 110-µm- and 90- µm thick corneal flap and to identify the potential factors that affect corneal flap thickness.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-40 year
* Preoperative spherical refraction of -2.00 to -10.00D.
* Refractive cylinder of less than -3.00D.
* A stable refractive state for 2 years.
* An intraocular pressure (IOP) of \<22 mm Hg.

Exclusion Criteria:

* A history of any systemic autoimmune disease.
* A history of diabetes.
* Other ophthalmic disorders.
* A history of ocular trauma and surgical history.
Molecular Mechanisms of Disease Relapse After Allogenic Stem Cell Transplantation in MDS Patients

This is a biological study for adult MDS patients who undergo HSCT procedure. Viable bone marrow samples will be collected and cryopreserved from MDS patients before transplantation and at clinical disease recurrence. CD34+ blast cells at disease relapse after HSCT will be compared with CD34+ cells collected before transplant to study genomic and transcriptomic changes.

This is a biological study for adult MDS patients who undergo HSCT procedure.The research is focused on the study of biological mechanisms of disease relapse after HSCT in MDS to provide the rationale to develop pre-emptive strategies in patients with high risk of transplant failure.

Viable bone marrow samples will be collected and cryopreserved from MDS patients before transplantation and at clinical disease recurrence.

CD34+ blast cells at disease relapse after HSCT will be compared with CD34+ cells collected before transplant by using Single-cell sequencing.

To study genomic and transcriptomic changes in CD34+ blast cells at disease relapse after HSCT will be used TARGET-seq in parallel with unbiased whole-transcriptome analysis.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of MDS according to 2016 WHO criteria
* Aged 18y or older
* Patients who will receive allogeneic stem cell transplantation (HSCT)
* Signed written informed consent according to ICH/EU/GCP and national local laws

Exclusion Criteria:

* Second HSCT procedure.
Effect of Sporebiotics in FD

Single-site prospective interventional study aiming to demonstrate the effect of spore-forming probiotics on dyspeptic symptoms and blood, saliva and stool parameters in FD patients with and without acid suppression, compared to placebo.

Prospective randomized placebo-controlled study in 2 parallel FD cohorts (8 weeks) with open-label extension phase (8 weeks):

* cohort 1FD (on-PPI): study procedures at inclusion (1) and after 8 weeks on-PPI+ sporebiotics or placebo (2) followed by 8 weeks on-PPI+ sporebiotics (open label)
* cohort 2FD (off-PPI): study procedures at inclusion (1) and after 8 weeks of sporebiotics or placebo (2) followed by 8 weeks of sporebiotics (open label)

Clinical outcomes and blood, saliva and stool parameters will be assessed at the beginning and end of each treatment period (week 0, 8 and 16) with additional questionnaires after 1 month (week 4 and 12).

Eligibility Criteria:
Inclusion Criteria:

* Patients \>18 years with FD diagnosis (Rome IV criteria)
* Male or female (not pregnant or lactating and using contraception or postmenopausal)
* Normal bowel habits (defecation once every 3 days up to 3 times a day)
* Witnessed written informed consent
* Access to home freezer (-18 to -20°C)
* Capable to understand and comply with the study requirements

Exclusion Criteria:

* Any active somatic or psychiatric condition that may explain dyspeptic symptoms (stable dose of single antidepressant allowed for psychiatric indication, no limitation for other indications)
* Predominant symptoms of gastro-esophageal reflux disease (GERD) or irritable bowel syndrome (IBS)
* Use of immunosuppressants or antibiotics \<3 months
* History of major abdominal surgery (except for appendectomy, cholecystectomy or splenectomy)
* Personal history of diabetes mellitus type 1, celiac disease or inflammatory bowel disease
* Diabetes mellitus type 2 (including therapy)
* Active malignancy (including therapy)
* Known HIV, HBV or HCV infection (including therapy)
* Significant alcohol use (\>10 units/weeks)
Study of Echocardiogram Accuracy in Patients With Mitral Valve Calcification

This study aims to evaluate the accuracy of the echocardiographic data obtained from patients with calcifications in the mitral valve who are undergoing a cardiac (heart) catheterization.

Echocardiography is a non-invasive (does not break the skin) procedure used to see an image of the heart. It uses harmless sound waves to create an image of the heart on a computer screen. These images will show the valves of the heart, how well the heart is pumping blood, the blood flow across these valves and how large the heart is. A silver paddle-shaped device is moved easily over the skin to capture these images.

Calcification (hardening) of the heart valves and heart rings (fibrous tissue surrounding the valves) is a common finding and it increases with age. The presence of calcification changes the blood flow through the heart valves. This makes any echocardiographic data (information) obtained from patients with calcifications difficult to interpret.

Patients with significant mitral annular calcification (MAC) have largely been excluded from studies validating non invasive (echocardiographic) measurements of left ventricular filling and diastolic function. The investigators hypothesize that echocardiographic estimates of diastolic function, left atrial pressure (LAP) and left ventricular end diastolic pressure (LVEDP) are likely to be fallacious in patients with moderate to severe mitral annular calcification due to the structural alterations and technical difficulties involved.

Eligibility Criteria:
Inclusion Criteria:

* \>= 19 years of age
* undergoing planned cardiac catheterization

Exclusion Criteria:

* \< 19 years of age
* acute coronary syndrome
* decompensated heart failure
* not in sinus rhythm
* \> mild MR
* hypertensive urgency/emergency
* severe aortic stenosis
* poor echo windows for Doppler imaging
Gelatin Sponge VS PTFE Membrane for Socket Sealing After Immediate Implant Placement

Digital panoramas will be made to assess the implant sites. The included patients are assigned to their respective groups randomly. After implant submerging in the study group 2 layers of hemostatic resorbable gelatin sponge is fixed in the implant site; while with the control group PTFE is fixed. After 3 weeks the PTFE was removed while the gelatin sponge should be resorbed. 3 months later the implants are to be assessed for stability and a reverse torque test was used to confirm osseointegration during uncovering.

Follow-up appointments at 1,3 weeks and 1,2 \& 3 months were planned.

Dental implants are considered the gold standard for treatment of edentulous spaces. Immediate implant placement has multiple advantages including the shorter treatment span, less surgical procedures and faster loading possibility \[1\]. One of the drawbacks of immediate implant placement is proper soft tissue coverage of the submerged implant to prevent socket infection and allow implant stability and osseointegration \[2\]. To overcome these issues the use of membranes has been the standard procedure \[3\].

Polytetrafluoroethylene membranes (PTFE) have been reported vastly in literature and their results and clinical effect on soft tissue healing and guided tissue regeneration (GTR) around implants and in surgical sites. Dense PTFE allows for GTR by only promoting non-bacterial migration and improving cellular adhesion which promotes tissue regeneration underneath it \[4\]. On the other hand, PTFE membranes are quite expensive and with the economic crisis the world is facing the use of other less expensive options is crucial. Gelatin sponges are vastly used as hemostatic agents in minor surgical procedures and have shown excellent results in terms of hemostasis and rapid resorption \[5\]. The application of such material are multiple; such as with sinus lift procedures \[6\], microvascular decompression\[7\] and as a wound dressing \[8\].

The investigators hereby propose the use of hemostatic gelatin sponges as membranes for submerged immediate implants as a simpler and cheaper alternative to PTFE.

Eligibility Criteria:
Inclusion Criteria:

* patients with badly broken down tooth indicated for immediate implantation
* generally healthy patients 22-50 years of age
* non smokers
* good oral hygiene

Exclusion Criteria:

* poor bone quality
* poor oral hygiene
* non compliant patient
Vein Histology in Arteriovenous Fistulas and Its Effect on Fistula Surgery Success

Patients whose kidneys have failed need to receive dialysis treatment, most commonly with a dialysis machine. In order to be connected to the machine an operation is often performed to join an artery to a vein in the arm. This forms what is known as an arteriovenous fistula. The fistula causes an increase in the flow of blood through the vein and the vein reacts to this by becoming bigger and thicker, making it easier to connect the patient to the machine.

The success rate for the operation is relatively low and only approximately 65 from every 100 operations is still working after a year. It is thought that one factor that may cause problems with the fistula is the ability of the vein to stretch in response to increased blood flow. Previous research has shown that veins in kidney failure patients look different to those of people whose kidneys are working when viewed under a microscope.

The investigators aim to study the structure of the vein that is used in making fistulas with a microscope and also to test it in an engineering laboratory to see how much it will stretch. The investigators hope that gaining information about the structure of the vein and its ability to stretch will help determine what it is about the vein that affects how well it works as part of a fistula. This information may help surgeons select the best possible vein in a given patient to give the best chance of a working fistula in the future.


Eligibility Criteria:
Inclusion Criteria:

1. Patients referred to vascular consultants for AV fistula formation for haemodialysis access.
2. Ability to give informed written consent
3. Aged over 18 at time of referral

Exclusion Criteria:

1. Veins identified on preoperative ultrasound scanning to be of a calibre too small to allow sufficient material to be obtained for biomechanical testing (\<3mm diameter).
2. Inability to give informed written consent
3. Aged under 18 at time of referral
4. Inability to attend follow-up appointments
TYPE 2 HEPATORENAL SYNDROME

Various vasoconstrictors have shown promising results in the management of type 1 hepatorenal syndrome (HRS). However, there are very few studies on vasopressors in the management of type 2 HRS. Terlipressin has been used commonly; however it is costly and not available in some countries. In the present study, the investigators evaluated safety and efficacy of terlipressin and noradrenaline in the treatment of type 2 HRS


Eligibility Criteria:
Inclusion Criteria:

1. Cirrhosis with ascites with serum creatinine more than 1.5 mg/dl and less than 2.5 mg/dl
2. Absence of shock, fluid losses and treatment with nephrotoxic drug
3. No improvement in renal function following diuretic withdrawal and plasma volume expansion
4. No ultrasound evidence of renal parenchymal disease or obstructive uropathy 5.Absence of proteinuria more than 500 mg/24 hour

Exclusion Criteria:

1. Patients with history of coronary artery disease
2. Cardiomyopathy
3. Ventricular arrhythmia
4. Obstructive arterial disease of limbs -
Centralized Pan-South African Survey on the Undertreatment of Hypercholesterolaemia

This is a multi-centre survey of patients who are currently on lipid lowering pharmacological treatment in South Africa.


Eligibility Criteria:
Inclusion Criteria:

* Subject must be 18 years of age or older of either gender or race.
* Subject must provide informed consent and comply with the survey procedures.
* Subject is on lipid lowering drug treatment for at least 3 months, with no dose change for a minimum of 6 weeks.

Exclusion Criteria:

* Subjects who are unwilling or unable to provide informed consent.
Comparison of Rabeprazole and Esomperazole for the Eradication of H. Pylori

Patients infected with H. pylori are treated with rabeprazole 10 mg bid, AMPC 750 mg bid and CAM 200 mg bid or esomeprazole 20 mg bid, AMPC 750 mg bid and CAM 200 mg bid. Eradication rates are compared. Patients who have ever failed in eradication by CAM-based regimen are treated with rabeprazole 10 mg bid, AMPC 750 mg bid and MNZ 250 mg bid or esomeprazole 20 mg bid, AMPC 750 mg bid and MNZ 250 mg bid.

Patients infected with H. pylori are treated with rabeprazole 10 mg bid, AMPC 750 mg bid and CAM 200 mg bid or esomeprazole 20 mg bid, AMPC 750 mg bid and CAM 200 mg bid. Eradication rates are compared. Patients who have ever failed in eradication by CAM-based regimen are treated with rabeprazole 10 mg bid, AMPC 750 mg bid and MNZ 250 mg bid or esomeprazole 20 mg bid, AMPC 750 mg bid and MNZ 250 mg bid. CYP2C19 genotypes and susceptibility to CAM are genetically measured. Other factors are also analyzed with reference to eradication rates.

Eligibility Criteria:
Inclusion Criteria:

* Patients infected with H. pylori who can undergo the eradication therapy

Exclusion Criteria:

* Patients with severe other disorders, cannot undergo eradication therapy, refuses to participate to the study.
Wolff-Parkinson-White Syndrome Anterograde Refractory Period of Accessory Duct

The study consists of the realization of a new esophageal stimulation for patients already stimulated 10 years ago.

The investigators would like to make a long term evaluation of the evolution of anterograde effective refractory period of accessory duct in the WPW syndrome.

This study will be realized by esophageal stimulation.


Eligibility Criteria:
Inclusion Criteria:

* 21 \< age \< 64 years
* First esophagal stimulation with evaluation of effective anterograde refractory period \> 10 years
* Informed consent signed
* Diagnosis of Wolff-Parkinson-White syndrome
* No procedure of ablation of accessory duct

Exclusion Criteria:

* Ablation of accessory duct
* Patient with contraindication to esophageal stimulation
* Patient with contraindication to effort test
A Phase II Study to Assess Changes in Physical Function in Elderly Patients With Chronic Anemia

The purpose of this study is to assess changes in physical function in elderly patients (\>= 65 years of age) with chronic anemia (Hb \<= 11.0 g/dL) due to anemia of unknown cause and receiving weekly subcutaneous doses of Epoetin alfa (PROCRITÂ®) versus placebo

Some elderly patients have a chronic condition that causes anemia (reduction in hemoglobin level, or low red cell count). Anemia occurs commonly with aging and is a frequent medical condition in individuals over the age of 65. Physical performance and function is generally worse in individuals who are anemic. This is a randomized, double-blind, placebo-controlled, multi-center study to assess physical function (to include falls) and fatigue in approximately 80 elderly patients with chronic anemia (anemia present for at least 3 months) and who are receiving weekly PROCRIT. The study will also evaluate hemoglobin levels (oxygen carrying protein in red blood cells), safety, fatigue and cognitive function. The study hypothesis is to demonstrate the study drug will be more effective in treatment of chronic anemia than placebo, resulting in the improvement of physical function and subsequent disabilities, generally well-tolerated. The patients will receive weekly injections of Epoetin alfa (PROCRIT®) or placebo at a starting dose of 10,000 units administered subcutaneously (under the skin).

Eligibility Criteria:
Inclusion Criteria:

* Patients with a history of chronic anemia defined as a documented Hb value of \<= 11.0 g/dL
* No active cancer
* At least 65 years of age with life expectancy of \> 6 months
* Community dwelling patients
* Patients with a Short Physical Performance (SPPB) Summary Score of 4-10 at screening and baseline
* Patients with an Mini Mental State Examination (MMSE) score \>= 24

Exclusion Criteria:

* Positive stool guaiac test
* Diagnosis of multiple myeloma and/or MGUS
* History of venous thromboembolytic disease
* Previous treatment with Epoetin alfa, Darbepoetin or any form of erythropoietin recently
* Uncontrolled or severe cardiovascular disease