cyrilzakka/clinical-trials huggingface dataset:
A Phase 4, Open-label Study to Assess the Feasibility and Efficacy on Motor and Non-motor Symptoms of Switching From Pramipexole or Ropinirole to Rotigotine Transdermal Patch in Subjects With Advanced Idiopathic Parkinson's Disease

The purpose of this study is to assess the safety and feasibility of switching subjects with advanced Parkinson's Disease (PD) from Pramipexole or Ropinirole to Rotigotine and to assess the effects of Rotigotine on motor and non-motor symptoms of Parkinson's Disease in subjects switched from previous treatment with either Pramipexole or Ropinirole.


Eligibility Criteria:
Inclusion Criteria:

* Subject has idiopathic Parkinson's Disease of more than 3 years duration, as defined by the cardinal sign, bradykinesia, plus the presence of at least 1 of the following: resting tremor, rigidity, impairment of postural reflexes and is without any other known or suspected cause of Parkinsonism
* Subject has motor fluctuations
* Subject is not satisfactorily controlled following the investigator´s assessment on a total daily dose of Pramipexole or Ropinirole
* Subject has sleep disturbance or early morning motor impairment
* Subject has experienced nocturia for at least 3 nights within 7 days prior to the Baseline Visit
* Subject is taking L-dopa in combination with Benserazide or Carbidopa and has been on a stable dose of L-dopa for at least 28 days prior to the Baseline Visit

Exclusion Criteria:

* Subject has had therapy with Tolcapone or Budipine
* Subject is receiving therapy with one of the following drugs either concurrently or within 28 days prior to Baseline (Visit 2): alpha-methyl dopa, metoclopramide, reserpine, neuroleptics, monoamine oxidase A (MAO-A) inhibitors, methylphenidate, or amphetamine
* Subject has a history of symptomatic (not asymptomatic) orthostatic hypotension in the 6 months prior to Baseline (Visit 2)
* Subject has a history of significant skin hypersensitivity to adhesive or other transdermal preparations, or recent unsolved contact dermatitis
* Subject has a history of seizures or stroke within 1 year, or a history of myocardial infarction within the last 6 months prior to enrollment
* Subject is pregnant or nursing, or is of childbearing potential but (i) not surgically sterile or (ii) not using adequate birth control methods (including at least 1 barrier method) or (iii) not sexually abstinent or (iv) not at least 2 years postmenopausal
* Subject has a previous diagnosis of narcolepsy, sleep apnea syndrome, restless legs syndrome, or periodic limb movement disorder
A Study Assessing the Safety, Efficacy, and Optimum Dosage of K-161 in Subjects With Moderate to Severe Dry Eye Disease

The objective of the study is to assess the safety, efficacy, optimum dosage, and dosing regimen of K-161 in adult subjects with moderate to severe dry eye disease.


Eligibility Criteria:
Inclusion Criteria:

* Be at least 18 years of age at the time of informed consent visit.
* Have a reported history of dry eye disease in both eyes and a history of eye drop use for dry eye symptoms.
* Meet all inclusion criteria outlined in the clinical study protocol.

Exclusion Criteria:

* Have any clinically significant ocular condition.
* Have a history of corneal refractive surgery and/or any other ocular surgical procedure within 12 months.
* Must not meet any other exclusion criteria outlined in the clinical study protocol.
Nasal Expiratory Resistance in Patients With Sleep Apnea and Expiratory Flow Limitation

Obstructive sleep apnea (OSA) is inherently site-specific. In a physiological controlled intervention study, the investigators seek to determine whether applying expiratory resistance can acutely improve ventilation and sleep in patients with expiratory flow limitation (EFL).

Collapse of the upper airway can occur at different sites of the pharynx. One common and recognizable form of pharyngeal collapse is prolapse of the soft palate (velopharynx) on expiration, a phenomenon referred to as expiratory flow limitation (EFL). In principle, application of nasal positive expiratory pressure should reverse expiratory narrowing, increase ventilation, and prevent the subsequent progressive loss of airflow that leads to arousal from sleep, thereby improving OSA. One means to achieve this expiratory pressure is with the use of an added nasal expiratory resistance.

Accordingly, during a single night protocol, the investigators will examine the effects of increasing nasal expiratory resistance during sleep. During obstructed breathing, patients will be switched acutely, in random order, from normal conditions to an added expiratory resistance (30-80 cmH2O/L.s) or a sham resistance, for short (1 min) and prolonged periods (1 hour), repeatedly overnight.

Patients participating in the study will be divided into two groups, those exhibiting EFL versus those without EFL (i.e. with inspiratory flow limitation).

The main outcomes of the short physiologic interventions are:

* Increase in ventilation, and
* Increased time to a respiratory-related arousal from sleep, relative to sham conditions.

The main outcome of the prolonged interventions is:

--Reduced frequency of respiratory events (AHI; 3% desaturation or arousal) relative to sham conditions.

The central objective of the study is to test whether there is a greater improvement in the above outcomes in those with EFL versus those without EFL.

This data will allow us to test whether expiratory resistance is of potential therapeutic benefit specifically in patients with EFL rather than those without EFL.

Eligibility Criteria:
Inclusion Criteria:

* Presence of obstructive sleep apnea (AHI\>10/hr)

Exclusion Criteria:

* Serious co-morbidities including lung disease, heart disease, renal disease
* Medications affecting respiration or sleep

Expiratory flow limitation (EFL) subgroup inclusion criteria: presence of clear EFL on polysomnographic study (reduced flow and increased pharyngeal pressure during expiration as a predominant cause of airflow obstruction).

non-EFL subgroup inclusion criteria: complete absence of EFL on polysomnographic study
Epidemiology of Breast Arterial Calcification

To test the hypothesis that breast arterial calcification (BAC) seen on mammograms can identify women with an increased risk of coronary artery disease (CAD).

BACKGROUND:

The study hypothesis is that breast arterial calcification (BAC) seen on mammograms can identify women with an increased risk of coronary artery disease (CAD). Annual mammograms are now routinely obtained on nearly 70% of women over forty years of age. The nearly 40 million examinations performed every year could be used to evaluate for BAC without any additional cost or change in current mammographic techniques. Identification of women with BAC has potential to substantially decrease the rate of heart attack and sudden death due to CAD in asymptomatic women. Before BAC can be used in a clinical setting, the age-specific prevalence of BAC needs to be fully defined using state of the art mammographic techniques. BAC then needs to be compared with well understood CAD risk factors and measures of coronary atherosclerosis. While this could be accomplished in a prospective study, the same goals can be attained using data already acquired in the Epidemiology of Coronary Calcification (ECAC) Study.

The study uses existing data on 612 non-high risk, non-referred women who are participants in the community-based ECAC Study funded by NIH from 1991-2006. This database includes traditional and newer coronary artery disease (CAD) risk factors and the results of electron beam computed tomography (EBCT) examinations for CAC at a baseline examination. Most of the women also have had risk factors and CAC measured during a follow-up examination, on average, five years after baseline examinations. The women in the ECAC Study, who do not have a history of myocardial infarction (MI) or stroke, represent the full age range routinely evaluated with mammograms. Almost all these women have their usual care, including annual mammograms, in Rochester, Minnesota.

DESIGN NARRATIVE:

The ECAC study has been instrumental in establishing the distribution of presence and quantity of CAC as well as the predictors of CAC. The database includes clinical and laboratory assessments of CAD risk factors, results of EBCTs, and findings on physical examinations. It will ultimately include information on adverse clinical events. There are 612 female participants who had one or more mammograms during the 12-year history of that study. Many women had 10 or more mammograms. The study will evaluate all of these mammograms for BAC and compare the findings with information already in the database. The combination of newly acquired data from mammograms with the existing data allows this to be a very comprehensive study and still be completed in the two-year time period. The findings can then be used to help design a future study to prospectively evaluate the impact of instituting preventive and early therapeutic measures for CAD in asymptomatic women with the appropriate features of BAC on mammography.

Eligibility Criteria:
No eligibility criteria
The Effect of Arm Exercises on Arm Oedema After Breast Cancer Surgery

In order to prevent lymphedema after breast surgery, patients are advised to know the risk factors for lymphedema and to avoid situations that may cause lymphedema, to perform active and passive arm exercises, to evaluate the affected area for lymphedema, to perform self-care and this should be under the self-management of the patients. Investigators think that this study will have a positive effect on the literature since there are no studies on risk scoring, the combined use of training and exercises to strengthen self-care skills in preventing the development of breast cancer-associated lymphedema. From this point of view, the study was planned as a randomized controlled experiment to examine the effects of preoperative lymphedema scoring and postoperative progressive upper extremity exercises on upper extremity function and self-care in women with breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* Female gender,
* Between 18-65 years old
* BMI ≤30 kg/m2
* Axillary lymph node dissection (removal of at least 2 lymph nodes),
* No history of cancer other than breast cancer,
* Does not have any chronic disease (such as diabetes mellitus, hypertension, chronic obstructive pulmonary disease) that prevents exercise
* No previous diagnosis of lymphedema,
* Not pregnant or breastfeeding during the study,
* Individuals who agree to participate in the study will be included in the study.

Exclusion Criteria:

* Total (simple) mastectomy,
* History of bilateral lymph node dissection,
* Lymphedema (difference \>2 cm with an intact extremity)
* Individuals who do not agree to participate in the study will not be included in the study.
Referral Guidelines for Imaging Exams: Impact on Exam Relevance and Associated Delays

The main objective of this study is to evaluate the impact of the implementation of referral guidelines for imaging exams requested by the emergency department on exam relevance. The latter is assessed via the rate of suspected diagnoses that are confirmed by the requested exam.

The secondary objectives of this study are to assess the impact of the implementation of referral guidelines for imaging exams requested by the emergency department on the following:

A. How exam results are classified in relation to the initial, suspected diagnosis.

B. Further aspects of exam relevance.

C. Delays associated with exams

D. Changes in practice in terms of type of examination, clinical situations, the number of tests ordered per patient, and emergency situations

E. Radiation and contrast agent exposures

Eligibility Criteria:
Inclusion Criteria:

* The patient (or his/her guardian/parent/person-of-trust) was correctly informed about the study
* A participating ER doctor has requested an imaging exam for the patient during one of the trial observation periods (ie the "before" period or the "after" period).

Exclusion Criteria:

* The patient is under judicial protection
* The patient (or his/her guardian/parent/person-of-trust) refuses to participate in the study
Effect of Cerefolin®/CerefolinNAC® on Biomarker Measurements

In a retrospective analysis of data from 1100 patients, disease-delaying effects of Cerefolin®/CerefolinNAC® were examined in terms of cognition. The purpose of the current study is to expand the retrospective study dataset by prospectively collecting additional biomarker and imaging data.

CerefolinNAC® is an orally administered prescription medical food, and is formulated as a combination of L-methylfolate calcium (as Metafolin®), methylcobalamin, and N-acetylcysteine. In a retrospective analysis, disease-delaying effects of Cerefolin®/CerefolinNAC® (CFLN) are examined in terms of cognition (measured by MCI Screen (MCIS)), and functional capacity (measured by Functional Assessment Staging Test (FAST)). - the treatment effect of CFLN on cognitive and functional measures, and on biomarker measures in patients with Alzheimer's disease and related disorders (ADRD).

The current study will expand the NAC-002b study dataset by prospectively collecting additional biomarker and imaging data in a more comprehensively assessed, matched sample of patients. This will allow more precise evaluation of cognitive and functional outcome measures, and biomarker measures will be assessed in an attempt to identify specific populations or conditions in which CFLN is most effective.

The sample will consist of patients with homocysteinemia plus past/current CFLN treatment (Treatment Group) matched to those without homocysteinemia plus no past/current B12, folate or CFLN treatment (Non-Treatment Group). Also 65 additional subjects will be recruited for the non-Treatment group, which will be used to improve the rate of decline estimates for the cognitive and functional outcome measures.

Eligibility Criteria:
Inclusion Criteria:

* With a diagnosis of normal aging (NL), cognitive impairment or dementia not otherwise specified (CI/D), or ADRD
* With at least one previous quantitative MRI (qMRI)
* With at least one previous homocysteine level
* Without homocysteinemia plus no past or current B12, folate or Cerefolin® treatment, OR with homocysteinemia plus past or current Cerefolin® treatment

Exclusion Criteria:

Subjects who do not meet the inclusion criteria will be excluded from the study.
Trial Comparing Kaffes Stent With Plastic Prosthesis in the Treatment of Anastomotic Biliary Strictures Post Orthotopic Liver Transplantation

Biliary anastomotic strictures (post liver transplantation) occur in 15-20 % of the cases. Biliary stenting using plastic prosthesis during a period of 1 year is the treatment of choice. Problematic in this approach is the regular change, necessary to overcome occlusion of the stent, resulting in cholestasis and/or infection. This change needs to be performed every 3 months or more frequently in patients with symptoms of stent occlusion.

The Kaffes stent (RMS) is a metallic removable stent, especially constructed for the treatment of biliary anastomotic strictures post liver transplantation. The advantage could be that this stent is less prone to occlusion with a lower change frequency (e.g. every 6 months).

No randomized, controlled trial (RCT) or data exist comparing plastic stenting versus Kaffes stenting.


Eligibility Criteria:
Inclusion Criteria:

* Patients after orthotopic liver transplantation with a choledocho- choledochal anastomosis, presenting with an anastomotic stricture
* diagnosis established by :

  * elevated liver tests
  * a narrowing of the anastomosis on Magnetic resonance cholangiopancreatography (MRCP): with or without intrahepatic bile duct dilatation
  * no acute or chronic rejection
  * no Cytomegalovirus (CMV) infection
  * no other possible causes of elevated liver tests
  * confirmation of the stricture needs to be confirmed during the diagnostic endoscopic retrograde cholangiopancreatography (ERCP) procedure immediately before the therapeutic procedure.

Exclusion Criteria:

* non-anastomotic strictures
* absence of informed consent
* Roux-en-Y construction
* Living related liver transplantation patients.
Conventional Impressions Versus Digital Impression Techniques for Implant Supported Screw Retained Prosthesis

The purpose was to evaluate the accuracy of traditional and digital implant level impression procedures by using three-dimensional superimposition analysis , and evaluate the passive fit of screw- retained implant supported restorations fabricated using conventional and digital impression techniques in bilateral distal extension cases (class I kennedy classification)

Eight patients who had missing all mandibular posterior teeth except first premolars were included in this study. In each patient, 4 implants were placed, 2 in each side to support 3 units screw retained zirconia restorations. Three months after implant placement, each patient underwent two implant level impression techniques (n=8) for each technique: Conventional implant impressions CII (pick-up, splinted transfers), and digital implant impressions DII were captured with TRIOS 3 Shape intraoral optical scanner. In this study, digital impression was considered as a reference data.

Eligibility Criteria:
Inclusion Criteria:

* All participants have sufficient bone length and width for implant insertion.
* General health of the patients was evaluated by taking a full medical history to ensure that these patients were free from any systemic conditions that would have impaired implant osseointegration
* Good oral hygiene
* Sufficient inter-arch spaces
* The opposing arch was almost dentulous, and any missing teeth were restored using a fixed partial denture.

Exclusion Criteria:

* parafunctional habits
* Heavy smoking
* Those patients with systemic diseases that may influence soft or hard tissue healing.
* Patients with a history of radiation therapy in the head and neck region.
* Patients with a history of radiation therapy in the head and neck region.
Corneal Crosslinking for Treatment of Corneal Neovascularization

The study objective is to assess safety and efficacy of photo-activation of riboflavin for treatment of corneal neovascularization with or without concomitant inflammation and/or infection.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* With active inflammation or infection causing vascularization and possibly melting of the cornea, or vessels extending into the cornea causing lipid deposition, or vascularization that could significantly increase the risk of rejection of a current or planned corneal transplant, or vessels that continue to extend into the cornea despite topical treatment with corticosteroids.
* Signed written informed consent.

Exclusion Criteria:

* Known sensitivity to treatment medications
* Current condition that in the investigator's opinion could compromise safety or data integrity.
* Pregnancy (including plan to become pregnant) or lactation during the course of the study
Efficacy of 5-fluorouracil and Low Molecular Weight Heparin in High-risk Pediatric Retinal Detachment

EVALUATION OF 5-FLOUROURACIL AND LOW MOLECULAR WEIGHT HEPARIN INTRAOPERATIVE INFUSION IN PREVENTING PROLIFERATIVE VITREORETINOPATHY IN HIGH RISK PEDIATRIC RHEGMATOGENOUS RETINAL DETACHMENT

After informed consent, children under 14 years of age with high-risk PRRD underwent pars plana vitrectomy and silicone oil injection with scleral buckle divided into 2 groups in prospective randomized trial. Group A received intraoperative infusion of 5-FU (200 µg/ml) and LMWH (5 IU/ml), group B received infusion of normal saline. Primary outcome was occurrence of recurrent PRRD within 12 weeks, secondary outcomes were occurrence of PVR, best corrected visual acuity (BCVA), number and timing of secondary procedures within 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

Children under 14 years of age with RRD undergoing primary repair Preoperative PVR grade B or higher High risk RRD: uveitis; large, giant, or multiple tears; vitreous hemorrhage; preoperative choroidal detachments; aphakia; and large detachments involving greater than two quadrants of the eye

Exclusion Criteria:

Children with RRD related to penetrating ocular trauma involving the posterior segment Previous RD repair surgery Uncontrolled glaucoma or other concomitant ocular morbidities Patients with bleeding diathesis, hepatic and renal failure Corneal opacity sufficient to impair surgical view No light perception vision Inability to complete follow-up
RadiatiOn Dose Among Different EndOvascular Procedures: the RODEO Study

Retrospective multicenter study aimed to evaluate radiation exposure associated with different interventional procedures involving interventional cardiologists, interventional radiologists and electrophysiologists.

The use fluoroscopically guided interventional procedures is progressively increasing over the past 20 years.Some previous reports have shown that the radiation dose absorbed by interventional cardiologists is the greatest registered by any medical staff exposed to X-rays. However in recent years new procedures have been introduced and validated in the setting of interventional cardiology and radiology and there is wide variation in patient dose among different procedures.

Radiation issue is an important issue for patients and operators due to the acute deterministic effects and most important for the long term stochastic risk of cancer induction: however this problem is often under-evaluated. Even if the stochastic risk is an all-or-none phenomenon for any individual cell, the greater the radiation exposure, the more cells are injured. Moreover non cancerous effects are possible such as cataract formation in the eye and the probability increases with increasing dose.

Radiation dose can be expressed in different ways: the Air Kerma is the amount of energy absorbed in a given mass of air, whereas the Dose Area Product (DAP) is the absorbed dose of radiation across a given surface area. Generally DAP measurements are more accurate than using Air Kerma measurements for the estimation of patient radiation dose as DAP allows for variations in field size. DAP consents a good estimation of the dose to the irradiated tissue and is an indicator for patient cancer risk.

Aim of our study is to evaluate the radiation dose exposure during different fluoroscopically guided interventional procedures comparing different specialties (electrophysiology, interventional radiology, interventional cardiology).

Methods From January 2013 to December 2015 all diagnostic or interventional procedures performed by interventional operators will be included in this multicenter study without exclusion criteria.

Collection of data will be retrospective in a dedicated database. Radiation exposure will be assessed measuring the DAP and fluoroscopy times for each procedure. Moreover for each procedure all the centers are requested to give information about operator, patient and procedure details.

End point of the study The primary end-point of the study is the comparison of DAP dose among interventional cardiologist, electrophysiologist and interventional radiologist procedures.

Secondary end-point of the study is to compare fluoroscopy times among different procedures.

Eligibility Criteria:
Inclusion Criteria:

* All procedures for which DAP values are available

Exclusion Criteria:

* Procedures without DAP