cyrilzakka/clinical-trials huggingface dataset:
Evaluation of the Jarvik 2000 Left Ventricular Assist System With Post-Auricular Connector--Destination Therapy Study

This investigation will be conducted as an interventional intention-to-treat clinical study in a population of end stage heart failure patients who meet specific inclusion and exclusion criteria. The multi-center study will be prospective, dual-armed, non-blinded (open-label) and randomized, comparing a treatment group receiving the Jarvik 2000 LVAS with Post-Auricular Connector to an active control group treated with the PMA approved Thoratec HeartMate® II LVAS for Destination Therapy.

Study Success for Primary Endpoint A will be established if the proportion of subjects in the Treatment Group meeting the Subject Success Criteria A, is determined to be non-inferior to that of the Control Group (at two years) according to the pre-specified statistical analysis.

Subject composite success requires the subject to achieve the Effectiveness Endpoint:

1. Two year actuarial survival
2. Freedom from procedures to repair, or replace the implanted device
3. Freedom from stroke resulting in a Modified Rankin Score of \>3 at the two-year follow-up

Study Success for Primary Endpoint B will be established if the proportion of subjects in the Treatment Group meeting the Subject Success Criteria B is determined to be superior to that of the Control Group (at three years) according to the pre-specified statistical analysis.

Subject composite success requires the subject to achieve the Effectiveness Endpoint:

1. Three year survival
2. Freedom from the serious adverse event of drive cable or pump pocket infection

Eligibility Criteria:
Inclusion Criteria:

1. Cardiac transplantation ineligible.
2. Late stage heart failure in NYHA Class IIIb or IV for at least 45 of past 60 days.
3. Cardiac Index \< 2.2 L / min / m2
4. LVEF = 25% or less
5. Patients on Optimal Medical Management (OMM) as defined in Section 9.2 OR dependent on intra-aortic balloon counter-pulsation for 7 days OR other temporary (indicated for 30 days use, or less) mechanical circulatory support for 7 days, OR supported with IV inotropes for 7 days and failing to respond.
6. BSA \> 1.2 m2 and \< 2.5 m2.

Exclusion Criteria:

1. History of cardiac transplantation or left ventricular reduction procedure.
2. Clinical conditions, other than heart failure, which could limit survival to less than three years.
3. Cause of heart failure due to, or associated with, uncorrected thyroid disease, obstructive / restrictive cardiomyopathy, pericardial disease, amyloidosis, dermatomyositis, or active myocarditis.
4. Intolerance to anti-coagulation or anti-aggregation therapy required for post-operative therapy.
5. Known sensitivity to products of bovine origin. The Jarvik 2000 incorporates a Hemashield vascular graft. Patients with a known sensitivity to products of bovine origin should not be implanted.
6. Chronic immunosuppression.
Vaginal Wound Infiltration Analgesia for Postoperative Pain After Laparoscopic Hysterectomy: a Randomized Trial

In cases of laparoscopic hysterectomy , women were randomized to two groups: ropivacaine ( vaginal wound infiltration analgesia) vs. control group. Results regarding postoperative pain and need of oxycodone.

Women assigned to laparoscopic hysterectomy were randomly divided into two groups as regard surgery: a ropivacaine group (RG) (n=41) and a control group (CG) (n=40). General anesthesia and use of local anesthetics were standardized. Visual analog scale (VAS) scores for pain and side effects (nausea/vomiting) and the amount of postoperative analgesic used were recorded for 24 hours.

Eligibility Criteria:
Inclusion Criteria:

The criteria for inclusion were scheduled laparoscopic hysterectomy

Exclusion Criteria:

The exclusion Criteria were contraindications to any of the forms of medication used in the study (oxycodone, ketoprofen, paracetamol), language difficulties ( inability to understand and speak Finnish or Swedish)
Evaluation of Visual - Motor Development in Children With Retinopathy of Prematurity

The aim of this study was to investigate the eye structure, visual impairment, visual motor development and motor coordination of children between 2-6 ages that had applied to diod laser photocoagulation and intravitreal anti - vascular endothelial growth factor treatment.

There are three different groups in this study. Children between 2-6 ages that had applied to diod laser photocoagulation and intravitreal anti - vascular endothelial growth factor treatment will have evaluated with Snellen Test, Titmus Fly Test, Optical Kohlerans Tomography, Beery-Buktenica Developmental Test of Visual Motor Integration, Peabody Developmental Motor Scales-II, World Health Organization Quality of Life - BREF and State - Trait Anxiety Inventory.

Eligibility Criteria:
Inclusion Criteria:

* Age range between 2-6 years of age
* Gestational age range 26-34. be between weeks
* To be diagnosed with retinopathy of prematurity
* Neurological, hereditary and not having metabolic disease
* Compliance with visual examinations and physiotherapy evaluations
* To be children and parents who agree to participate in the study

Exclusion Criteria:

* To be a child who does not comply with Optical Kohlerans Tomography (OCT)
* Not participating in one or more of the eye examination or physiotherapy assessments
* Being children and parents who do not agree to participate in the study
A Follow-on Study for Second-Eye Treatment for Participants Previously Treated With Gene Therapy for X-Linked Retinitis Pigmentosa (XLRP)

The purpose of this study is to assess the safety and tolerability of subretinal delivery of Adeno-associated Virus Vector (AAV5 hRKp.RPGR) gene therapy in adults and children with X-linked retinitis pigmentosa.


Eligibility Criteria:
Inclusion Criteria:

* Have been treated with AAV5-hRKp.RPGR in study MGT009 and have completed or is currently enrolled in Study MGT010
* Must sign an informed consent form indicating that they understand the purpose and procedures of the study and is willing to participate in the study
* Willing to adhere to the protocol and long-term follow-up

Exclusion Criteria:

- There are no specific exclusion criteria to enroll in this study
Effect of Aging on Micro-tensile Bond Strength and Color Stability of Self-adhesive Resin Composite

The objective of this study is to evaluate the micro-tensile bond strength of a newly self-adhesive resinous restorative material to dentin with and without application of universal bonding system (in-vitro) and to examine it's clinical performance by evaluation of it's color stability and marginal discoloration through a randomized clinical trial (in-vivo).

For color stability and marginal discoloration test, twenty class I cavities were prepared in the molar teeth of twenty different patients and then were randomly divided into two groups of ten patients each, where half of the molars was restored with Surefil one self-adhesive bulk-fill composite and the other half with Filtek One bulk-fill composite. A VITA Easyshade spectrophotometer was used to measure the baseline color of the restoration and at the margin after 24 hours and degree of color change and marginal discoloration after 3 months and 6 months of composite placement and then degree of color change (ΔE) was determined using the CIE L\*a\*b\* system. All discolored restored molar teeth of both composite types were polished using a series of different thickness of Sof-Lex aluminum oxide discs (coarse, medium, fine), then the degree of color change of the restoration and at the margin (ΔE) was determined and was then compared to the baseline color measurements.

Eligibility Criteria:
Inclusion Criteria:

* Patients with class I lesion in their maxillary or mandibular molars with a maximum of approximately 2 mm final cavity depth.
* Patients with teeth shade A2 according to Vitapan classical shade guide.
* Patients with an acceptable oral hygiene level.
* Patients keen to regularly attend the follow up visits.

Exclusion Criteria:

* Patients with heavy bruxism or traumatic occlusion.
* Patients with poor oral hygiene or active periodontal disease.
* Patients with exposed or endodontically treated teeth.
* Patients participated in a clinical trial within 6 months before beginning of this trial.
* Patients who decline to be involved in the study or sign the written consent.
* Patients unable to return for the follow up visits.
Transcranial Direct Current Stimulation (tDCS) as Treatment Method for Pain in Fibromyalgia

The purpose of this study is to investigate Transcranial Direct Current Stimulation as treatment method for pain in fibromyalgia.

Fibromyalgia (FIM) is a chronic pain condition with high prevalence. Studies involving neuroimaging techniques have identified functional differences in cerebral pain processing in patients with FIM, as compared to healthy controls. This may support that FIM do have a functional CNS component.

Transcranial Direct Current Stimulation (tDCS) is a non-invasive and safe method for inducing changes in cortical excitability. Previous studies showed that anodal stimulation of M1 may change pain perception, possibly by modulating functional anomalies in the FIM brain. The present study has two main goals:

1. To investigate if tDCS may provide FIM patients with symptom relief due to reduction of pain.
2. To investigate tDCS induced functional changes in the brain by using fMRI.

Eligibility Criteria:
Inclusion Criteria:

* Fibromyalgia (ACR-90 criteria, M79.7 ICD10)
* Mean VAS \> 4 daily 2 weeks prior to study).

Exclusion Criteria:

* Severe mental disease
* CNS disease
* Mental retardation
* Age \< 18
Outcome of Arthroscopic Repair of Chronic Rotator Cuff Tears Between 2005-2008

Arthroscopic repair has become the preferable surgical technique to treat rotator cuff tears in the last decade. Many researches demonstrate equal and even superior outcome with this surgical technique, while others show opposite results.

The aim of this study is to estimate the anatomic and functional results of the arthroscopic repair among the patients of the orthopedic department at the Soroka University Medical Center, in order to check the investigators hypothesis that indeed - the arthroscopic repair of the rotator cuff is the better surgical technique.

Methods: study population - 80 patients who had had an arthroscopic repair of the rotator cuff between the years 2005-2008 at the SUMC.

Inclusion criteria: age over 18 years. arthroscopic rotator cuff repair. date of operation not before 2005.

Study design:

1. Data base Collection.
2. Inviting the patients for physical examination + ultrasound examination of the operated shoulder + filling out questionnaires (SF36, CONSTANT SCORE)
3. Statistical analysis
4. Publication


Eligibility Criteria:
Inclusion Criteria:

* Age over 18 years
* Arthroscopic repair of chronic rotator cuff tear
* Operation done after January 2005
Uromodulin in Rheumatoid Arthritis

The aim of the present study was to evaluate the levels of uromodulin in rheumatoid arthritis (RA) and to investigate whether it was correlated with baseline clinical characteristics. In addition CKD epi,MDRD,urine microalbuminuria,pH,serum urea, creatinine,CRP (C-Reactive protein) were measured.The participants consist of ; %68 patients,% 32 control group.

Uromodulin, also known as Tamm-Horsfall protein, is a protein abundantly excreted in the urine in healthy individuals. It is synthesized in the thick ascending limb of Henle (TALH) and the early distal convoluted tubule. Its biologic function is still obscure; however, some experimental studies indicated that it might serve as an important urinary defense factor against bacterial colonization and stone formation.

There are controversial publications on the frequencies of urinary tract infections and nephrolithiasis in patients with mutations of uromodulin gene. Deposition of mutated uromodulin in the urinary system may lead to tubular cell dysfunction and apoptosis. These alterations may subsequently cause tubular atrophy and interstitial fibrosis . Moreover, the release of abnormal uromodulin after apoptosis through basolateral secretion may elicit an immune response which may give rise to an immune-mediated tubulointerstitial nephritis .

Uromodulin can activate the other components of the immune system and may modulate the inflammatory and immune responses through different mechanisms .

Experimental studies yielded that uromodulin negative mice displayed splenomegaly with infiltration of white pulp by macrophages and increased levels of TNF-α and interleukin-1 . Rheumatoid arthritis is a systemic autoimmune condition that may eventually result in the joint damage, disability and premature mortality.

Eligibility Criteria:
Inclusion Criteria:

* Patients who diagnosed of rheumatoid arthritis as criteria of ACR/EULAR 2010.
* All patients age range is 18-80 years.

Exclusion Criteria :

* Renal failure
* Hepatic insufficiency
* Diabetes mellitus
* Other collagen vascular diseases,
* History of smoking and consumption of alcohol
Effects of Exercise Modality on Abdominal Obesity and Health Risk Factors in Older Men and Women

The prevalence of abdominal obesity in the elderly is increasing at alarming rates and thus, requires immediate attention. By comparison to younger adults, obesity reduction in the elderly presents a unique challenge and requires an innovative approach. We propose a novel approach to investigate the effects of different exercise types as independent treatment strategies for the reduction of obesity and related health risk factors in older men and women. We propose that exercise without caloric restriction will be associated with modest weight loss (3-5%), that in turn will be associated with significant reduction in abdominal obesity, insulin resistance, and a corresponding increase in skeletal muscle mass and function. We will determine the separate effects of resistance and aerobic exercise on these primary outcome variables, and, whether a treatment strategy that combines the two is optimal.


Eligibility Criteria:
Inclusion Criteria:

* Men and women between 65 and 80 years of age.
* Men and women are self-sufficient, sedentary, abdominally obese (BMI between 27 and 34.9 kg/m2; waist circumference greater than 88 cm in women and 102 cm in men), weight stable (± 2 kg) for 6 months prior to the beginning of the study, be non-smokers, and not diabetic.
* We will study elderly women who are not taking hormone replacement therapy to create a homogeneous population in whom the effect of exercise on the principal outcome variables can be evaluated with minimal confounding.

Exclusion Criteria:

* Smokers and diabetics.
* Women taking hormone replacement therapy.
Non-comparative Study to Assess the Visual Performances and Safety of a Progressive Multifocal Intraocular Lens

This is an interventional, non-controlled, multicenter international trial with a prospective design on one cohort of patients.

To evaluate if the positive results (to assure a good visual acuity at all distances and a good quality of life in terms of glasses independence and absence of undesired events), obtained experimentally using the IOL MINI WELL READY, can be confirmed in the practical surgical routine with a population belonging to different EU countries

Eligibility Criteria:
Inclusion Criteria:

* Any gender and age above 18 years.
* Refractive lens exchange (RLE) or cataract surgery.
* Healthy corneas, not treated surgically.
* Patients willing to have surgery in both eyes in a short period of time (within 2 weeks).
* Patients request to receive the IOL MINI WELL READY implant

Exclusion Criteria:

* Previous corneal surgery (i.e. pterygium, refractive surgery).
* Eye diseases determining a probable postoperative visual acuity \< 20/40.
* Pseudoexfoliation.
* Abnormal pupil size and position.
* Use of contact lens 30 days before the preoperative visit.
* Corneal warpage.
* Predicted postoperative corneal astigmatism higher than 1 D.
A Chinese Herbal Decoction for Stress Urinary Incontinence

The purpose of this study is to determine whether Yiqi Suoquan Tang, a Chinese Herbal decoction, is effective in the treatment of female stress urinary incontinence.

The pilot randomized, controlled trial is aimed to preliminarily assess the effectiveness of Yiqi Suoquan Tang, a Chinese Herbal decoction, in the treatment of female stress urinary incontinence (SUI). Eligible participants will be randomly allocated to receiving Yiqi Suoquan Tang or pelvic floor muscle training (PFMT) using a random number generator in a 1:1 ratio. To minimize the evaluation bias, the outcome assessors and statisticians will be masked to treatment allocation.

Assuming a two-sided alpha of 0.05, power of 90%, and a 20% drop-out, a sample size of 36 would be needed for each group. The statistical analysis will be performed based on the intention-to-treat principle, which is defined as patients that have received at least one treatment. Missing data will be replaced by the last observed value. Continuous variables will be compared by Student t test or Mann-Whitney U test; categorical variables will be analyzed by chi-square test, Fisher's exact test or Kruskal-Wallis H test as appropriate. For comparison between two time points, paired t-test or Wilcoxon signed rank test will be used as appropriate. A statistically significant difference was set at P\<0.05.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of stress urinary incontinence
* Must be able to swallow Chinese hebal decoction

Exclusion Criteria:

* Urinary tract infection
* Neurogenic bladder
* Pelvic organ prolapse \> stage 2
* Overactive bladder
* Previous anti-incontinence surgery
* Post-void residual urine volume (PVR) \> 100ml.
Blood and Saliva Sample Collection for AREDS 2

Background:

- The Age-Related Eye Disease Study 2 (AREDS 2) is looking at different eye diseases. Study participants will provide blood and saliva samples. The samples will be stored for research on eye diseases.

Objectives:

- To collect blood and saliva samples for AREDS 2 research.

Eligibility:

- AREDS 2 research study participants.

Design:

* Participants will provide blood and saliva samples.
* The samples will be submitted with personal and medical information. This information will be collected during the AREDS 2 procedures.

AREDS2 is a multi-center, Phase III, randomized clinical trial designed to assess the effects of oral supplementation of high doses of macular xanthophylls (lutein and zeaxanthin) and/or omega-3 long-chain polyunsaturated fatty acids (LCPUFAs) as a treatment for age-related macular degeneration (AMD), cataract and moderate vision loss. In addition to this objective, the AREDS2 study will provide information on the clinical course, prognosis, and risk factors for development and progression of both AMD and cataract. Other study goals include the evaluation of eliminating beta-carotene and/or reducing zinc in the original AREDS formulation on the progression and development of AMD. AREDS2 will also seek to validate the fundus photographic AMD scale developed from AREDS.

The objective of this protocol is to have AREDS2 participants submit blood and saliva samples to the AREDS2 Genetic Repository (Fisher BioServices, Rockville, MD) in order to provide further materials for the study of the genetic and biochemical bases for eye disease and possibly other diseases.

Eligibility Criteria:
* INCLUSION CRITERIA:

Participants will be eligible if they were enrolled in the AREDS2 protocol and willing to have their blood drawn and saliva collected.

EXCLUSION CRITERIA:

Participants will not be eligible if they were not enrolled in AREDS2 and are not willing to have their blood drawn and saliva collected.
Safety Study of Femoral Neck Fracture System

The purpose of this study is to assess the reoperation rate of fractures that have occurred at the neck of the femur that are treated with the CONQUEST FN Femoral Neck Fracture System. The CONQUEST FN Femoral Neck Fracture System is approved for use by the United States Food and Drug Administration (FDA). It consists of a stainless steel plate and up to three (3) screws intended to treat both non-displaced and displaced fractures to the femoral neck.

The CONQUEST FN™ represents the next generation femoral neck fracture system designed to offer better intra-operative reduction control with the assurance of eliminating device failure modes. This system is dedicated to treating both non-displaced and displaced intracapsular fractures of the femoral neck. It is a dynamic locked implant system that provides multiple points of fixed angle support with continuous compression across the fracture site, ensuring bone-on-bone contact during the fracture union process. The continuous fracture site compression and post-operative reduction maintenance is accomplished with the incorporation of telescoping compression screw technology. The novel system empowers surgeons to address the current surgical challenges and often unfavorable patient outcomes and high re-operation rate associated with the current treatment options for intracapsular femoral neck fractures.

This study will evaluate the re-operation rate for any reason of displaced and non-displaced femoral neck fractures treated with the CONQUEST FN Femoral Neck Fracture System at one year post-operation.

Eligibility Criteria:
Inclusion Criteria:

1. Must be 18 years of age or older
2. Must provide written informed consent
3. Willing to make all required study visits for one year post-operation
4. Subject has experienced a displaced or non-displaced intracapsular femoral neck fracture and is scheduled for repair using the CONQUEST FN Femoral Neck Fracture System.

Exclusion Criteria:

1. Subject with known sensitivity or allergies to stainless steel
2. Subject with fracture occurring more than 7 days prior to surgery
3. Subject has more than one fracture on the hip requiring surgery
4. Subject is considered obese by a Body Mass Index \> 40 at the time of surgery
5. Therapy with another investigational agent within thirty 30 days of screening
6. Subject has emotional or neurological condition that precludes cooperation and compliance
7. Subject has undergone previous surgery on hip.
8. Subject has severe bow of the target hip or gross distortion of the femur.
9. Current systemic therapy with cytotoxic drugs
10. Subject has a physical condition that would preclude adequate implant support or impede healing (e.g. blood supply impairment, insufficient bone quality or quantity, or an active local or systemic infection).