cyrilzakka/clinical-trials huggingface dataset:
CEC/EPC and Cardiovascular Risk in Renal Transplant Recipients

We believe that certain cells in the human body (Circulating Endothelial Cells and Endothelial Progenitor Cells) are related to risk of cardiovascular disease. It may be possible to measure levels of these cells in patients who have had a kidney transplant and predict their risk of developing cardiovascular disease.

Coronary disease is one of the most common causes of morbidity and mortality in patients with known chronic renal insufficiency and those with end stage renal disease. Consequently, early detection with markers such as circulating endothelial cells and endothelial progenitor cells has been studied in order to identify vascular function and assess overall cardiovascular risk. Based on current research, there exists a notable increase in Circulating Endothelial Cells (CEC) and a reduction of Endothelial Progenitor Cells (EPC) with renal dysfunction due to endothelial damage. Therefore circulating endothelial cells are a marker for cardiovascular health.

Renal transplant patients also possess a higher cardiovascular risk than the general population, but have known improvement in survival as compared to patients with ESRD (End Stage Renal Disease). In addition, because of the excellent outcomes, graft and patient survival and even acute rejection are no longer very useful endpoints for clinical studies. The tolerability of transplant drug regimens and the impact of these regimes on cardiovascular health in kidney transplantation has become, consequently, a new focus of research. Currently, no clear long-term analysis has been fulfilled analyzing CEC or EPC in this group of patients. We hypothesize that CEC can serve as biological markers for cardiovascular risk assessment in cadaveric and living renal transplant patients. We eventually hope measurement of these cells can serve as an endpoint in determining cardiovascular outcome in renal transplant patients. Our present study is aimed to get an initial assessment of the kinetics of CEC and EPC in renal transplant recipients just prior to transplant and for the first two years post transplant.

Eligibility Criteria:
Inclusion Criteria:

* kidney transplant recipients
* kidney/pancreas transplant recipients
* age 18-80

Exclusion Criteria:

* inability to return for follow-up visits
* multiple organ transplant other than listed above
Weight Loss Plus Omega-3 Fatty Acids or Placebo in High Risk Women

The purpose of this study is to determine if high dose supplementation with the omega-3 fatty acids EPA and DHA, when added to a weight loss program, is well tolerated in the study population and if there is an increase in the favorable change in blood and tissue breast cancer risk factors when compared to weight loss alone.

Subjects will all participate in a 6-month weight loss intervention. Subjects will be randomized to receive either blinded placebo or omega-3 fatty acids for 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Evidence of Hyperplasia with Masood score of 13 or higher and 500 or more epithelial cells on cytology slide of screening Random Periareolar Fine Needle Aspiration (RPFNA)
* Access to smart phone and or computer
* Willing to comply with diet, exercise and lifestyle modification during weight reduction and maintenance phase.
* Willing to start the dietary and exercise intervention within 9 months of RPFNA
* Willing to complete quality of life questionnaires at multiple visits
* Willing to have a medical history and physical at multiple visits
* Willing to have an additional RPFNA at two additional visits
* Be willing to have blood drawn at multiple visits
* Willing to sign and able to understand consent for the RPFNA's and study participation
* Reasonable hematopoetic, kidney and liver function consistent with safe participation on this trial.

Exclusion Criteria:

* Having taken medications that seriously affect metabolism such as steroids, dexatrim or other diet drugs within 3 weeks of study registration
* Have changed dose or type of hormone supplementation within 3 months
* Currently receiving other investigational agents
* Have been on a chemoprevention trial within 6 months or taken a Selective Estrogen Receptor Modulator or aromatase inhibitor within last 6 months.
* Need for chronic use of aspirin, nonsteroidal anti-inflamatory drug (NSAID) or other anti-inflammatory agents
* Taking metformin, or other diabetes medications
* Taking statins
* Unable to participate in moderate intensity exercise (walking, treadmill, elliptical, water aerobics)
* Would be unable to participate, by phone, in weekly phone call sessions
* Cells suspicious for malignancy as assessed by cytotechnologist or cytopathologist.
Frequency and E-field Enhancement of ITBS for Depression (FREED)

The investigators propose a randomized 3-arm double-blinded parallel experimental trial (20 sessions over 4 weeks) in 75 patients with TRD. The three arms include (1) the combination of a fully Individualized form of intermittent Theta Burst Stimulation (iTBS) (using BOTH the frequency and electric field (E-field) targeting approaches) (Ind-iTBS)), (2) iTBS individualized using E-field targeting only (targeted-iTBS) and (3) Standard iTBS treatment (i.e., typical iTBS localized to the dorsolateral prefrontal cortex (DLPFC) using the Beam F3 method). Electroencephalography (EEG) data will be collected at rest and during a working memory task, at baseline, and at the end of treatment along with clinical assessments of depression severity. The target engagement dependent variable of interest in these three arms will be fronto-parietal theta connectivity measured through resting-state EEG. The investigators hypothesize that stimulation with Ind-iTBS will lead to greater changes in fronto-parietal theta connectivity than that produced with targeted-TBS and standard iTBS. Aim: To evaluate the effects of two individualized forms of iTBS (i.e., using BOTH the frequency and E-field individualization; Ind-iTBS) compared to iTBS individualized for E-field targeting only (targeted-iTBS) and standard iTBS on fronto-parietal theta connectivity. Hypotheses: (1) Ind-iTBS will lead to greater changes in fronto-parietal theta connectivity compared to both targeted-iTBS and standard iTBS. (2) Ind-iTBS will also lead to a greater reduction in depressive symptoms (as defined by the mean reduction in Montgomery Åsberg Depression Rating Scale Scores (MADRS)) compared to both targeted-iTBS and standard iTBS.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of major depressive episode (MDE, in accordance with the Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-5), in the context of unipolar major depressive disorder disorder.
* 18-80 years of age.
* Male or female.
* At least one failed antidepressant medication trial at level 3 in the Antidepressant Treatment History Form: Short Form (ATHF-SF) classification.
* Montgomery-Asberg Depression Rating Scale (MADRS) Score of \>19 (moderate - severe depression).
* No increase or initiation of new antidepressant therapy in the four weeks prior to screening.
* Demonstrated capacity to give informed consent.

Exclusion Criteria:

* Inability to provide informed consent.
* Medically unstable patients.
* Concomitant neurological disorder or a history of a seizure disorder.
* Patients who are pregnant or breastfeeding.
* Any psychotic disorder or current active psychotic symptoms.
* Patients who have intracranial implants, other medical device or condition deemed unsafe for TMS.
* Contraindication to MRI scanning.
Genetic Predisposition of Coronary Artery Disease -- The COROGENE-Study

The aim of this study is to identify genetic loci,or gene variations contributing to inflammation and to the development of CHD. We will compare coronary angiogram results to genetic findings within coronary artery disease patients and in patients with normal coronaries.

Coronary artery disease (CAD) is a chronic inflammatory disease, progression of which may be accelerated by immunological mechanisms. Genes involved in regulation of inflammation and protection against infectious agents may affect picture of the disease . Major Histocompatibility Complex (MHC) region carries genes involved in innate and adaptive immunity and inflammation. We have for the first time, identified genetic factors located in HLA region, showing several fold risk for disease predisposition likely forming an important component to explain the high incidence of coronary heart disease in the Finnish population.

The aim of this study is to rerun our preliminary results, and further identify genetic loci, or gene variations contributing to the development of CHD. The strategy is to collect altogether 5000 patients assigned to coronary angiogram in Helsinki University Central Hospital. We will compare the angiogram results to genetic findings first in patients with normal coronaries, and in patients with different stages of CHD. Secondly we will compare phenotypic changes in inflammation and try to find out if the phenotype differs in different genotypes. Thirdly we will collect patients from hospital discharge registry, and compare mortality and morbidity results in different gene groups.

Finally, we aim to record echocardiograms of the aortic valves in altogether 3500 consecutive patients undergoing coronary angiography. We try to identify genetic loci and gene variations contributing to the fibrosis and calcification of the aortic valve.

The results of the study provide a possibility to develop a gene test to recognize patients at risk at its early stage, and needing for preventive medicine.

Eligibility Criteria:
Inclusion Criteria:

* Patient assigned to coronary angiogram

Exclusion Criteria:

* Inability to give informed consent
Nocturnal Oxygenation and Sleep-related Breathing Disorders During the First Night of a Stay at 2500m of High Altitude in Patients With Precapillary Pulmonary Hypertension

The impact of hypoxia at 2500m of high altitude on sleep in patients with precapillary pulmonary hypertension


Eligibility Criteria:
Inclusion Criteria:

* Informed consent as documented by signature (Appendix Informed Consent Form)
* PH class I (PAH) or IV (CTEPH) diagnosed according to guidelines: mean pulmonary artery pressure \>20 mmHg, pulmonary vascular resistance ≥3 wood units, pulmonary arterial wedge pressure ≤15 mmHg during baseline measures at the diagnostic right-heart catheterization

Exclusion Criteria:

* resting partial pressure of oxygen \<8 kilopascal at Zurich at 490 m low altitude
* exposure to an altitude \>1000 m for ≥3 nights during the last 2 weeks before the study
* inability to follow the procedures of the study
* other clinically significant concomitant end-stage disease (e.g., renal failure, hepatic dysfunction)
Powered Bone Marrow Aspiration and Core Biopsy System Compared to Manual Devices

This is a randomized study evaluating use of a powered bone marrow biopsy and aspiration system (OnControl by Vidacare) compared to traditional manual devices. The hypothesis is that the powered system will reduce the level of patient pain during the aspiration and core biopsy procedures and the amount of time needed to perform the procedures.


Eligibility Criteria:
Inclusion Criteria:

* Adults over the age of 18
* Patients that require core biopsy alone, or core biopsy and bone marrow aspiration

Exclusion Criteria:

* Imprisoned
* Pregnant
* Cognitively impaired
* Requiring english language translation other than Spanish
* Patients with one or more conditions precluding bone marrow core biopsy
Crossover Comparison of Tidal Volume Delivery During Nasal Intermittent Positive Pressure Ventilation in Preterm Infants: Infant Cannula vs. Nasal Continuous Positive Airway Pressure Prongs

Crossover bedside clinical study to examine relative tidal volume delivery during nasal intermittent positive pressure ventilation (NIPPV) and directly compare the RAM® infant cannula to a nasal continuous positive airway pressure (nCPAP) delivery system in vivo. The study population will consist of preterm neonates with mild respiratory insufficiency who are receiving NIPPV, non-invasive neurally adjusted ventilatory assist (NIV NAVA), or nCPAP.

Bedside crossover study of neonates with mild respiratory distress receiving NIPPV. Infants serve as their own controls and are randomized to initial interface of either RAM® infant cannula or Miniflow® nCPAP prongs. Infants are instrumented with the following monitoring equipment: Edi orogastric tube to measure electrical activity of the diaphragm, transcutaneous monitor to measure transcutaneous CO2 and O2, pulse oximeter to measure heart rate and oxygen saturation, and respiratory inductance plethysmography (RIP) bands around the chest and abdomen to measure breathing movements and relative Vt (arbitrary units, a.u.). Data are continuously and simultaneously acquired using a data acquisition system. After 10 minutes of stabilization, infants receive 5 minutes of NIPPV on each of a sequence of four commonly used pressure settings (expressed as peak inspiratory pressure / positive end expiratory pressure): 16/5, 16/8, 20/5, 20/8. This sequence is not randomized and is constant between interfaces. Subjects are then placed on the alternate interface, and the sequence is repeated. Events ("breaths") are separated into 3 types: patient effort synchronized with NIPPV breaths (type I), NIPPV breaths without patient effort (type II), and patient effort without NIPPV breaths (type III).

Eligibility Criteria:
Inclusion Criteria:

* Chronologic age less than 28 days
* Gestational age at birth between 24 weeks 0 days to 34 weeks 6 days
* Currently receiving NIPPV, NIV NAVA, or nCPAP

Exclusion Criteria:

* Oxygen requirement greater than 40%
* Peak inspiratory pressure greater than 20 cm H2O
* Major congenital anomalies of the heart or lungs
Perifoveal Vascular Network Assessed by OCT-Angiography in Type I Diabetes Mellitus

This study is directed to evaluate the role of Optical Coherence Tomography Angiography (OCT-A) in the evaluation of the perifoveal vascular network in type 1 diabetic patients, and to investigate the relationship between OCT-A-derived parameters and demographic and clinical factors, as metabolic control and duration of the disease.

Diabetic retinopathy (DR) is the leading cause of blindness in type 1 Diabetes Mellitus (DM) patients, as a consequence of impaired blood flow in the retina. Optical coherence tomography angiography (OCT-A) is a newly developed, non-invasive, retinal imaging technique that allows detection of perfused and non perfused areas of the retina without the injection of dye. This OCT-based method permits adequate delineation of the perifoveal vascular network, and allows objective identification of microvascular changes, such as capillary dilation or presence of microaneurisms. It is also capable to detect paramacular areas of capillary non perfusion and/or enlargement of the foveal avascular zone (FAZ), representing an excellent tool for assessment of diabetic retinopathy.

Given that all these features are commonly seen in diabetic patients, the relationship of these microvascular changes with systemic factors such as metabolic control or duration of the disease still need to be elucidated. Interestingly, further studies are required to investigate whether these changes reflect those occurring elsewhere in the body affected by diabetic microvascular disease, as the kidneys or the brain. If these relationships were demonstrated, early detection of these microvascular changes could lead to modifications in the pharmacological management of diabetic patients, as a way to reduce the risk of future complications in both the eye and other organs. The aim of this study is to evaluate the role of OCT-A in the evaluation of the perifoveal vascular network in type 1 diabetic patients, and to investigate the relationship between these OCT-A-derived parameters and demographic and clinical factors, as metabolic control and duration of the disease.

Eligibility Criteria:
Inclusion Criteria:

* Type 1 Diabetes Mellitus
* Healthy controls

Exclusion Criteria:

* Ocular pathologies other than diabetic retinopathy (i.e. age-related macular degeneration, retinal vein occlusions, uveitis, glaucoma, etc.)
* Axial length: \<-6.00 to \>+3.00 diopters
* Media Opacities
* Unability to capture OCT images
Multicomponent Behavioral Sleep Intervention for Insomnia in Older Adults With Mild Cognitive Impairment

Insomnia symptoms in older adults with mild cognitive impairment represent a significant public health burden in terms of impaired quality of life, risks from untreated insomnia, and risks from pharmaceutical insomnia treatment. To address the limitations in the most effective non-pharmacological treatments for insomnia in older adults with mild cognitive impairment, a randomized pilot study will be conducted to test a brief (4 week), tablet-based, personalized, multicomponent behavioral sleep intervention for insomnia, compared to a sleep education control, in this at-risk group. The findings of the proposed project will inform future, larger scale clinical trials and may provide a novel and innovative way for older adults with mild cognitive impairment to achieve better sleep and health-related quality of life outcomes.


Eligibility Criteria:
Inclusion Criteria:

* 1) age 55 and older
* 2) mild cognitive impairment (MCI) The Telephone Interview for Cognitive Status 13-item modified (TICS-M) version will be used to screen participants for eligibility in the study. We will include participants with TICS-M scores of 28-36, based off ranges and optimal cutpoints determined in various studies.
* 3) have insomnia symptoms a)answer yes to "Do you have trouble falling asleep, staying asleep, awakening too early, or have unrefreshing sleep" and b) have subjective sleep diary evidence of insomnia, with an average sleep onset latency \>30 min or wakefulness after sleep onset of \>60 min during the one week pre-treatment assessment
* 4) live in the community
* 5) speak English as primary language

Exclusion Criteria:

* 1) Presence of moderate to severe cognitive impairment defined as TICS score \<28
* 2) Visual or manual dexterity impairment that prevents them from pressing yes/no buttons, or selecting a number at 24 point font
* 3) Current sedative-hypnotic or other sleep aid use on a regular or as needed schedule within the prior three months
* 4) Presence of an acute medical or psychiatric condition which, in the judgement of the research team, would interfere with the subject's ability to realistically follow the study protocol
Comparison Of Radiation Exposure To Patients During Endoscopic Retrograde Cholangiopancreatography (ERCP) Performed By Endoscopists Trained In Judicious Use Of Fluoroscopy With Those Without Formal Training

Purpose: To compare the radiation exposure in patients during Endoscopic retrograde cholangiopancreatography (ERCP) done by Endoscopists formally trained in judicious use of fluoroscopy versus ERCPs done by Endoscopists without such formal training.

Research design: This is an observational study to compare radiation exposure in patients during ERCPs based on formal training.

Procedures to be used: None Risks and potential benefits There are no risks associated with this study as it is a retrospective chart review. Potential benefits include the knowledge gained from this study which may be of help to patients in the future.

Importance of knowledge that may reasonably be expected to result The knowledge gained from this study may be of help to provide new insights and develop newer guidelines for radiation use in the future.


Eligibility Criteria:
Inclusion Criteria:

* Any indications for undergoing an ERCP. If a patient undergoes more than one ERCP then it shall be reported as such, as multiple data points.
* Only those ERCP cases will be included that have been exposed to fluoroscopy (X-ray radiation).
* Adult populations will be included, all races and belonging to any gender will be included in the study.

Exclusion Criteria:

* Patients who didn't receive ERCP
* Those in whom the biliary or pancreatic ducts are not cannulated and therefore who do not receive any fluoroscopy
* Pregnant women
* Patient population less than 18 years of age
This Study is Designed to Evaluate PD/PK and Safety of Replagal Manufactured by Two Different Processes.

This study is designed to evaluate safety and PK/PD in Canadian Fabry patients.

In 2008, a change in the agalsidase alfa drug substance manufacturing process was made. There are no changes to the drug product formulation, manufacturing site, manufacturing process, or container closure.

An agalsidase alfa bioreactor manufacturing process (agalAF1) utilizing animal component-free media replaced the previous roller bottle (RB) process.

This study is designed to provide PD/PK and safety data. The assessment schedule is designed to capture the PK profile of drug uptake in the blood as well the pharmacologic effect which manifests over the course of weeks. Each patient will serve as his own control.

Eligibility Criteria:
Inclusion Criteria:

1. The patient must be diagnosed with Fabry disease using the following criteria: The patient is a hemizygous male with Fabry disease as confirmed by a deficiency of α-galactosidase A activity measured in serum, leukocytes, or fibroblasts or has a confirmed mutation of the α-galactosidase A gene.
2. Patient is male and between 18 and 65 years of age, inclusive.
3. Patient must be willing to remain in the clinic as required by the study and comply with the procedures and evaluations of the study.
4. At the time of confirmation of study eligibility visit, patients must have received at least 26 weeks of treatment with RB Replagal at a dose of 0.2 mg/kg administered IV EOW.
5. Patient provides informed consent.

Patients who are naive to ERT:

1. Treatment naive patients must have a pretreatment plasma Gb3 level above the normal range (if value is available).

Exclusion Criteria:

1. Patient is unable to be venipunctured and/or tolerate venous access.
2. Patient has tested positive for anti-agalsidase alfa antibodies either at screening or confirmation of eligibility visit.
3. Patient had pre-ERT plasma Gb3 levels within the normal range (if value is available).
4. Patient is participating in any other Shire HGT investigational study.
5. Patient is currently on dialysis, is expected to begin dialysis during the study, has received a kidney transplant, or is on the renal transplant waiting list.
6. Patient is unable to comply with the protocol (eg, clinical relevant medical condition making implementation of the protocol difficult, unstable social situation, or otherwise unlikely to complete the study) or is, in the opinion of the Investigator, otherwise unsuited for the study.
7. The patient is enrolled in another clinical study that involves clinical investigations or use of any investigational product (drug or device), except for the Canadian Fabry Disease Initiative, within 6 months prior to receiving the first dose of AF Replagal in this study or at any time during the study.
8. The patient has previously received AF Replagal prior to study entry.
Uptake and Acceptability of Home-use of Mifepristone for Medical Abortion

The primary aim of this study is to assess the acceptability of home-use mifepristone for termination of pregnancy among women who choose it and their providers. The investigators' secondary aims are to assess rates of follow-up, adherence, efficacy, complications, lost productivity, and to estimate the minimum proportion of women who choose home-use over clinic use of mifepristone.


Eligibility Criteria:
Inclusion Criteria:

* Reproductive age women seeking abortion services.
* Eligible women will be in general good health and assessed by a clinician to have an intrauterine pregnancy less than 64 days L.M.P on the day mifepristone will be taken.
* Participants must be eligible for medical abortion according to clinician and clinic standards.
* In the United States, women only 18 years and older will be eligible to participate, unless the study site obtains a waiver to include minors.