cyrilzakka/clinical-trials huggingface dataset:
Additional KIF6 Risk Offers Better Adherence to Statins

Many patients prescribed statins to lower their cholesterol stop taking their statin over time. The purpose of this study is to determine whether providing subjects their KIF6 carrier status (associated with increased cardiovascular event risk) will improve adherence to statin medications.

Coronary Heart Disease (CHD) remains a significant problem in the US, causing about 1 of every 5 deaths in 2005. In 2009, approximately 1.3 million Americans will have a new/recurrent myocardial infarction. Coronary heart disease (CHD) includes myocardial infarction, stable or unstable angina, demonstrated myocardial ischemia detected by noninvasive testing, and a history of coronary artery procedures (such a stent or bypass). Currently, "statins" are recommended by the AHA to manage elevated low-density lipoprotein-cholesterol (LDL-C). Unfortunately, the discontinuation of statins is quite substantial. For example, a large cohort study of older patients found that 2-year statin adherence rates were approximately 40% for acute coronary syndrome patients, 36% for chronic coronary artery disease, and 25% for primary prevention and is associated with increased mortality, hospitalizations, and costs. Recently, the kinesin 6 (KIF6) gene has been associated with a 30-55% increase in cardiovascular events in individuals carrying one or two risk variants (\~57% of the white population) in multiple prospective studies. Furthermore, KIF6 carriers receiving a "statin" have a substantial greater cardiovascular risk reduction (-34 to 50%) when using a "statin" compared to those that are non-carriers using a statin (6 to 20%). In this prospective, open label, trial, recruited subjects recently started on statin therapy will be provided information about their KIF6 carrier status and followed for 6 months to determine their "statin" adherence. Additionally, quality of life and factors adherence will be measured at baseline and after 6 months. Finally, pharmacy records will be evaluated for up to 1-year to determine statin discontinuation rates.

Eligibility Criteria:
Inclusion Criteria:

* Men and women at least 18 years of age
* New statin prescription
* Medco RationalMed® Program
* Data contains patient contact information (e.g. phone number)
* Data contains provider contact information
* Willing to sign informed consent and send KIF6 test results to their provider

Exclusion Criteria:

* Statin prescription in the previous 6 months
* Subject refusal to participate in this study (record reason from subject)
* Physician refusal to participate in this study (record reason from provider)
* Anticipated statin discontinuation within 6 months
* Any condition that would prevent the subject from completing the 6 month study follow-up period
* Subject with "no contact red flag"
* Subject residing in NY, NJ, MA, PA
Effects of Vitamin D3 Versus 25OHD3 on Mineral Metabolism and Immune Function

The purpose of this study is to compare the effects of two different forms of vitamin D supplements (vitamin D3 and 25-hyrdroxyvitamin D3 \[25(OH)D3\]) on vitamin D levels in the blood, and on markers of skeletal and immune health. This study is designed as a pilot study. A multi-ethnic cohort of 48 patients will be included (12 Caucasian, 12 African American, 12 Hispanic/Latino, 12 Asian/Asian American). Potential study candidates will undergo a screening visit during which a medical history will be taken, a physical exam performed, a dietary questionnaire administered, and blood collected. The purpose of the screening visit is to identify vitamin D-deficient (25-hydroxyvitamin D \<20 ng/ml) individuals who are candidates for vitamin D supplementation. Eligible patients will then be randomly assigned to receive either vitamin D3 (2400 IU/day) or 25(OH)D3 (20 mcg/day) for 16 weeks. After initiating supplementation, study patients will return for follow-up visits at weeks 4, 8, and 16. At each visit, blood will be collected to assess vitamin D levels in the blood, as well as markers of skeletal and immune function. Participation in this study will therefore involve a total of 5 visits (1 screening visit, 1 randomization visit during which participants will receive their study supplements, 3 follow-up visits). After all data is collected, changes in vitamin D levels in the blood following supplementation with either vitamin D3 versus 25(OH)D3 will be determined, and correlated to markers of calcium balance and immune function. Knowledge gained from this study may have a significant impact on how vitamin D status is defined, and how vitamin D repletion is administered.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18
* 25D \< 20 mg/ml

Exclusion Criteria:

* Age \< 18
* 25D \> 20 ng/ml at time of screening
* Clear signs of infection at time of screening (coughing, sneezing, wheezing, frequency, dysuria)
* History of conditions that would influence intestinal absorption of vitamin D3 or 25OHD3 supplements
* History of nephrolithiasis, primary hyperparathyroidism, or other metabolic bone disease
* History of chronic kidney disease (defined as CrCl \< 30 ml/min)
* History of rheumatologic or autoimmune conditions
* History of sarcoidosis
* History of active or latent tuberculosis
* History of HIV
* History of hyperthyroidism
* History of chronic glucocorticoid use defined as the equivalent of 5 mg of prednisone per day for more than 2 months within the last 6 months
* History of use of medications known to affect calcium/vitamin D metabolism, bone metabolism, and immune response
* Hypercalcemia
* Hypercalcinuria
A Smartphone Application of "Family Connections" to Relatives of People With Borderline Personality Disorder.

The aims of our study are the following: (a) testing the effectiveness of a combined intervention: "Family Connections" program with a smartphone app versus the same intervention supported by a paper-based manual, (b) studying the feasibility and acceptance of both conditions and (c) evaluating the perceptions and opinions of families about both interventions.

Family members of patients with borderline personality disorder (BPD) often experience high levels of suffering, anxiety, stress, burden and helplessness. The treatment program with the most empirical support is "Family Connections". It is one of the first programs specifically designed to help relatives of patients with BPD. The program is an adaptation of multiple strategies of Dialectical Behavioral Therapy. The results of these studies and their subsequent replications showed an improvement in family attitudes and perceived burden. Two of the technologies with very promising developments are Ecological Momentary Assessment and Ecological Momentary Intervention, that can act on each other. A large number of smartphone apps for people with psychological problems focus on the provision of instructions, adaptive self-help strategies, alarms, electronic diaries or emotional state ratings. The Family Connections app proposed in this article consists of a smartphone app built using EMA and EMI technologies.The aims of our study are the following: (a) testing the effectiveness of a combined intervention: "Family Connections" program with a smartphone app versus the same intervention supported by a paper-based manual, (b) studying the feasibility and acceptance of both conditions and (c) evaluating the perceptions and opinions of families about both interventions.

Eligibility Criteria:
Inclusion Criteria:

* Having a family member diagnosed with borderline personality disorder.
* Being 18 years of age or older.
* Knowing and understanding the Spanish language.
* Having a smartphone with Internet connection.
* Completing the informed consent.
Comparison of Two Different Pupillometer

With the development of refractive surgery, the size of scotopic pupil has been widely concerned by clinicians. Historically, the measurement of pupil size included the use of a pupil ruler, which is known for its drawback of being very subjective and lacking precision. While infrared pupillometry devices such as OPD-Scan III and Sirius are available for accurately and reliably measuring pupil size. Nevertheless, the aforementioned equipments are costly and cumbersome to move in terms of screening and field trial logistics settings. And 2WIN-S is a portable refractor, it can in a short period of diopter and scotopic pupil size and other data obtained at the same time. Therefore, the aim of this study was to compare the agreement between 2WIN-S and OPD-Scan III in measuring scotopic pupil size and the repeatability of 2WIN-S.

Pupil diameter is a parameter of great interest in understanding brain systems and modern refractive surgery. Pupillometry, the measurement of variations in pupil dilation, has offered encouraging evidence for the involvement of disturbed reactivity in depression risk, according to studies. According to research, the pupil dilates in reaction to stimuli requiring a larger cognitive load or a greater emotional intensity. Importantly, studies have related pupil size variations to brain activity in regions associated with emotion regulation, including the dorsolateral prefrontal cortex (DPFC) and the agenesis of the corpus callosum (ACC) . Thus, pupillometry is proposed as a viable peripheral gauge for a variety of brain systems involved in the processing of emotional information.

Some of the postoperative complaints of patients having refractive corneal or lens surgery are related to visual quality and are associated with large pupils since optical aberrations become more dominant when the pupil dilates . If the pupil size exceeds the optical zone size, a marked increase in higher-order aberrations could be observed. Patients might complain about poor contrast sensitivity, increased glare disability, or halos. Precise measurement of scotopic pupil diameter has therefore become an essential step in the preoperative evaluation of patients suitable for refractive surgery and is an important inclusion or exclusion criterion.

This study aimed to assess the agreement and reproducibility of scotopic pupil size measurements using 2WIN-S compared with OPD-Scan III in Chinese adults.

Eligibility Criteria:
Inclusion Criteria:

* \>18 years old
* signed informed consent
* willing to participate in the study

Exclusion Criteria:

Exclusion criteria were ocular pathology known to interfere with pupillometer outcome and pupil abnormalities (eg: glaucoma, iritis, cataract, corneal scarring, any history of ocular surgery, and history of trauma.)
Effect of tACS Stimulation on Alpha Oscillations

Transcranial Alternating Current Stimulation (tACS) is one method that has been demonstrated to enhance alpha oscillations in healthy participants by applying weak electrical currents to the scalp to modulate rhythmic brain activity patterns. This study will involve tACS-induced frontal alpha oscillations, EEG recordings, and other physiological and biological measures.


Eligibility Criteria:
Inclusion Criteria:

* Ages 18-65
* Capacity to understand all relevant risks and potential benefits of the study (informed consent)
* Negative pregnancy test for female participants

Exclusion Criteria:

* History of major neurological or psychiatric illness, including epilepsy
* Medication use associated with neurological or psychiatric illnesses
* Currently undergoing counseling or psychotherapy treatment for depression, anxiety, eating disorders, PTSD or other behavioral conditions
* First degree relative (parent, sibling, child) with major neurological or psychiatric illness
* Prior brain surgery
* Major head injury
* Any brain devices/implants (including cochlear implants and aneurysm clips)
* Braids or other hair styling that prevents direct access to the scalp (if removal not possible)
* Skin allergies or very sensitive skin
* Pregnant or nursing females
* Failure to pass a urinary drug test at the first session
* Use of hormonal birth control or supplements in the past two weeks
* Non English speakers
* Cardiovascular disease
Efficacy and Safety of Olanzapine in the Extended Treatment for Manic or Mixed Episode of Bipolar I Disorder

The efficacy and safety of the extended treatment to patients with most recent episode manic or mixed who completed previous double blind study (F1D-JE-BMAC \[Study BMAC\]) will be examined.


Eligibility Criteria:
Inclusion Criteria:

* Enrolled in and completed Study BMAC (NCT00129220), or those who discontinued Study BMAC at Visit 4 or Visit 5 due to lack of efficacy and for whom the Young Mania Rating Scale (YMRS) total score at the time of discontinuation was not lower than that at baseline of Study BMAC
* Are diagnosed as "294.4x Bipolar I Disorder, Most Recent Episode Manic" or "296.6x Bipolar I Disorder, Most Recent Episode Mixed," as determined by the Mini-International Neuropsychiatric Interview (MINI)

Exclusion Criteria:

* Have a diagnosis of diabetes mellitus
* Significant protocol deviation in Study BMAC
* The actual date of the final visit of Study BMAC is 4 days or more later than the scheduled date of first visit in Study BMEX
Neural Markers of Balance in Adults With Brain Injury

The feasibility study is designed to assess the feasibility of conducting a group yoga intervention and acquiring neuroimaging data in adults with chronic brain injury.

In the United States in 2014, nearly 2.9 million individuals sustained traumatic brain injuries that resulted in emergency department visits, hospitalizations, and death. Traumatic brain injury (TBI) is caused by trauma, or an external force that creates rapid acceleration and deceleration of the brain within the skull creating lasting neurophysiological dysfunction. Although there are many effective treatment strategies for the weeks and months post-injury (e.g. intensive, multi-disciplinary in-patient rehabilitation), millions of individuals are living with residual disability from brain injury following discharge to home. This residual disability can include significant social, cognitive, emotional, and physical impairment. To date, there are limited strategies for treating the residual deficits of chronic brain injury. One such physical deficit is balance impairment, which is associated with increased fall risk, reduced community integration, and decreased quality of life. The use of intensive, holistic rehabilitation may be effective for improving balance and other impairments in individuals with chronic brain injury. Yoga, a holistic treatment option, is thought to be more therapeutic than traditional exercise because of the integration of the mind, body, and spirit. Further, yoga can be modified to accommodate individual abilities and needs. And, unlike formal rehabilitation, yoga does not need to be approved by insurance or prescribed by a physician and adapted yoga is available in the community. Thus, yoga is readily available, so long as yoga instructors are trained to appropriately modify activities. Recently, the research team found that group yoga improved balance performance in seven adults with chronic brain injury. This study is designed to test the feasibility of conducting another group yoga intervention and acquiring neuroimaging data before and after the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Adults, ages 18+
* Diagnosis of traumatic brain injury (TBI) or acquired brain injury (ABI) that occurred ≥ 6 months prior,
* Self-reported balance limitations.

Exclusion Criteria:

* Ability to engage in non-adapted (i.e. mainstream) yoga classes
* Standard contraindications for MRI (e.g. metal plates in head, claustrophobia, etc.)\*

  * Individuals could still participate in the group yoga intervention even if they could not complete MRI scans.
Influence of Vasopressors on Anti-Xa Activity in Critically Ill Patients

Critically ill patients require antithrombotic prophylaxis. At the same time, majority of them is receiving various vasopressors. The aim of the study is to determine whether there is a difference in anti-Xa activity, which is a marker of anti thrombotic activity of low molecular weight heparins, between the patients receiving norepinephrine with argipressin, compared to those receiving norepinephrine alone.


Eligibility Criteria:
Inclusion Criteria:

* Circulatory failure
* Supported by continuous infusion of noradrenaline or noradrenaline and argipressin
* Receiving subcutaneous dalteparin for the prevention of venous thromboembolism.

Exclusion Criteria:

* Contraindications for dalteparin
* Severe coagulopathy
* Acute or subacute bacterial endocarditis
* Pregnant women
* BMI (body mass index) \> 30kg/m2
* Chronic kidney disease with eGFR (estimated glomerular filtration rate) \< 30 ml/min/1.73 m2
* Renal replacement therapy
* The patient died within 52 hours of starting VTE (venous thromboembolism) prophylaxis with dalteparin
Effectiveness of Group GDS and Individual GDS for Treatment of Low Back Pain in Primary Care

A cluster, randomized, controlled clinical trial, where the hypothesis is that Group GDS and Individual GDS are effective in the treatment of nonspecific low back pain. The clusters will be the participating physiotherapy departments in primary care who treat patients with low back pain. In each physiotherapy department there will be 3 groups: education group, Group GDS and Individual GDS. Patients will be followed for 12 months. Variables will be: demographic,intensity of pain, disability, quality of life, patient satisfaction, medication intake for current episode, non-pharmacologic treatment for current episode, co-morbidity, diagnostic tests, sick leave, and habitual physical activity. The questionnaires to be used are: Roland Morris Disability Questionnaire, PI-NRS, VAS, SF-12 and EQ-5d.


Eligibility Criteria:
Inclusion Criteria:

* diagnosed with nonspecific low back pain by the primary care physician
* more than or equal to 18 and less than or equal to 65 years of age

Exclusion Criteria:

* not signing the informed consent form
* pregnancy
* diagnosis of inflammatory rheumatologic disease, cancer, or fibromyalgia
* signs for suspicion of fibromyalgia
* having red flags for systemic disease
* presenting criteria for urgent referral to surgery
* presenting criteria for non-urgent referral to surgery
* inability to read, understand, or follow verbal orders (dementia,blindness, doesn´t know how to read)
* bedridden
* having received physiotherapy in last 12 months
Performance of EOS Imaging System in the Assessment of Spondyloarthritis Structural Changes Compared With Standard Radiography

Spondyloarthritis is a chronic rheumatic disease that requires prolonged radiographic follow-up. This repetitive exposure to ionizing radiation puts at risk the radiosensitive organs exposed in the field of irradiation. A new low-dose imaging system has emerged. This technique, called EOS, offers the advantage of lower irradiation associated with high images quality. Our goal through this work was to evaluate the reliability of the EOS imaging system compared to conventional radiography in the evaluation of the structural damage of SpA.

Spondyloarthritis (SpA) is a chronic inflammatory disease that can affect the sacroiliac joints, the spine and / or the peripheral joints. It is characterized by a progressive and slow evolution over several years with a risk of ankylosis of the spine. It requires long-term follow-up of patients with repeated x-rays to assess structural damage. This repeated and cumulative exposure to radiation ionization puts at risk the radiosensitive organs that are in the field of irradiation.

EOS is a new low dose X-ray system that significantly reduces X-ray doses compared to conventional radiography. This system allows the global assessment of the entire skeleton from head to toe, static spine and lower limbs with the obtaining of two-dimensional images of high quality with the possibility of a three-dimensional reconstruction. Although the benefits of the EOS system are promising with regard to radiation dose reduction, few studies have investigated its use in SpA and little evidence has supported its reliability in assessing the structural damage caused by the disease.

Eligibility Criteria:
Inclusion Criteria:

* Patients with Spondyloarthritis (SpA) meeting the criteria of Amor and / or Assessement of spondyloarthritis International Society (ASAS)
* Indication of standard radiography for the follow-up of the patients.

Exclusion Criteria:

* the presence of a contraindication to the performance of conventional radiography (CR) or EOS imaging
* any disease affecting cognition
* Patients who have had surgery on the spine and / or hip.
Pilot Feasibility Study With Patients Who Are at High Risk For Developing Invasive Candidiasis in a Critical Care Setting (MK-0991-067)

This is a pilot feasibility study that investigates antifungal therapy with caspofungin in patients at high-risk for developing invasive candidiasis in a critical care setting.

Hypothesis: In high-risk non-neutropenic participants in the ICU, the proportion of participants discontinued from study therapy in order to be empirically treated with antifungal therapy for suspected candidiasis outside of the context of this protocol is less than 20% (i.e., the upper bound of the 95% confidence interval for the observed proportion is less than 20%).

Eligibility Criteria:
Inclusion Criteria:

* Hospitalization for a minimum of 3 days in an ICU and expectation to stay in the ICU for at least another 48 hours
* Meets the following high-risk criteria: Requires mechanical ventilation at the time of study entry; and has a central venous catheter in place at the time of study entry; and is receiving broad spectrum antibiotics at the time of study entry; AND meets at least one of the following criteria: Required parenteral nutrition during the current ICU admission; or required renal dialysis during the current ICU admission; or had major surgery during or within the 7 days before the current ICU admission; or was diagnosed with pancreatitis during or within the 7 days before the current ICU admission; or required systemic steroids or other immunosuppressive agents during or within the 7 days before the current ICU admission
* Meets at least one of the following criteria of suspected infection at the time of study entry or within the 24 hours before study entry: Temperature ≥38° C or ≤36° C (oral equivalent); or hypotension (systolic blood pressure of \<90 mm Hg) or significant drop in blood pressure (40 mm Hg) from the participant's normal baseline; or elevated white blood cell count of ≥12,000/mm\^3
* Candida is growing in at least one non-sterile culture site collected during the current ICU admission
* Female of childbearing potential has a negative serum or urine pregnancy test before enrollment

Exclusion Criteria:

* Females pregnant or breast feeding
* History of allergy, hypersensitivity, or any serious reaction to caspofungin or another member of the echinocandin class (e.g., micafungin, anidulafungin)
* Neutropenia or expected to develop neutropenia during study therapy
* Diagnosis of acquired immune deficiency syndrome (AIDS), aplastic anemia, or chronic granulomatous disease
* Diagnosis of moderate or severe hepatic insufficiency
* Patient not expected to survive at least 24 hours
* Received systemic (IV or oral) antifungal therapy within 10 days before study entry
* Active diagnosis of proven or probable invasive fungal infection (IFI)
* Currently on or has received an investigational agent within 10 days before study entry
* Any condition or concomitant illness which might confuse the study results or pose additional risk in administering the study therapy