cyrilzakka/clinical-trials huggingface dataset:
Apremilast Pregnancy Exposure Registry

The purpose of the Apremilast Pregnancy Exposure Registry is to monitor planned and unplanned pregnancies exposed to apremilast and to evaluate the safety of this medication relative to specified pregnancy outcomes, and to evaluate potential effects of prenatal apremilast exposure on infant health status through one year of age.

The Apremilast Pregnancy Exposure Registry (Registry) is a United States (U.S.) based registry designed to monitor planned or unplanned pregnancies exposed to apremilast when used to treat an approved indication in accordance with the current approved prescribing information, who reside in the U.S. or Canada.

The goal of the Registry is to conduct an observational, controlled prospective cohort study that will involve follow-up of live born infants to one year of age.

The primary objective of the Registry is to evaluate any potential increase in the risk of major birth defects, specifically a pattern of anomalies, in apremilast exposed pregnancies compared to the primary comparison group of disease-matched unexposed pregnancies. Secondary objectives are to evaluate the potential effect of exposure relative to the secondary comparison group of healthy pregnant women, and the effect of exposure on other adverse pregnancy outcomes including spontaneous abortion or stillbirth, preterm delivery, reduced infant birth size, a pattern of minor malformations, postnatal growth of live born children to one year of age, and incidence of serious or opportunistic infections or malignancies in live born children up to one year of age.

The Pregnancy Exposure Registry is sponsored by Celgene Corporation and is conducted by the Organization of Teratology Information Specialists (OTIS) Research Group and is administered by investigators at the coordinating site located at the University of California, San Diego. The study is planned for seven years.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant

Exclusion Criteria:

-
Study of Gastrointestinal Dysfunction and Enteric Neural Pathology in Patients With Parkinson's Disease

The goal of this research is to determine (1) the feasibility of tethered capsule OCT esophageal imaging in the Parkinson's Disease population; (2) the morphologic changes in the enteric nervous system of the esophagus in patients with Parkinson's disease.

The purpose of this study is to establish the esophageal pathology findings as imaged with tethered capsule microscopy in subjects with Parkinson Disease. Images from patients with Parkinson disease will be compared to our previously obtained images in healthy subjects to establish the spectrum of esophageal pathologies occurring in patients with Parkinson disease by OCT imaging.

In the case of imaging internal luminal organs, like the esophagus, OCT light is delivered via a long catheter. We have developed a new technique termed Tethered Capsule Endomicroscopy (TCE). TCE involves swallowing a tethered capsule that acquires cross-sectional microscopic images of the entire esophagus as it traverses the luminal organ via peristalsis or is pulled up towards the mouth using tether. The catheter is connected to the imaging system, and the side-viewing optical beam rotates either proximally by a motorized rotary joint or distally by a micro-motor, effectuating circular scanning of the lumen wall. Three-dimensional OCT of the entire length of the lumen can be acquired by simultaneous rotation and translation of the focused OCT beam creating a helical pattern.

Eligibility Criteria:
Inclusion Criteria:

* Idiopathic Parkinson's disease as defined by the United Kingdom PD Society Brain Bank Criteria
* Parkinson Disease Hoehn and Yahr stage 2-4
* Subjects on stable dose of Parkinson Disease medications for at least 4 weeks prior to the study screening
* Subjects between 40 and 85 years old
* Subjects who are capable of giving informed consent
* Subjects who had no solid food for at least 4 hours prior to the procedure, and only clear liquids for 2 hours prior to the procedure

Exclusion Criteria:

* Atypical or secondary Parkinson Disease
* Esophageal fistula and/or esophageal strictures with a luminal stricture diameter that is smaller than the diameter of the capsule
* Recent intestinal resection (within the last six months)
* Prior gastric, esophageal or oropharyngeal surgery
* Inability to swallow capsules
* Pregnancy, according to patient information
Feasibility Clinical Study of NLA Tool-US

The study is to evaluate the feasibility of the NLA tool, a combined assessment of nutritional and physical functional status, to provide personalized advice for the independence and mobility of elderly.

* Determining the proportion of elderly subjects who, according to the NLA result, would qualify for a personalized program to improve their nutritional and physical status;
* Determining the segmentation (defined by cut-off criteria) of these elderly subjects stratified into 3 NLA subgroups according to strength and endurance performance (33% +/- 10% of target group)

Eligibility Criteria:
Inclusion Criteria:

1. aged between 65 and 90 years,
2. able to walk with or without walking aid,
3. having obtained the subject's written informed consent
4. free of cognitive impairment (3MSE),

Exclusion Criteria:

1. self reported restriction to exercise(by a physician or other).
2. unable to carry out performance tests and questionnaires correctly,
3. self reported lower or upper extremity surgery or fracture in the last 3 months
4. self-reported symptomatic coronary artery disease, myocardial infarction in last 6 months
5. self reported history of neurological disease (e.g., Parkinson disease, stroke) with residual impairment
6. uncontrolled hypertension (\>150/90 mm Hg)
7. self reported congestive heart failure
8. unable to communicate in English. Non-English speaking individuals will be excluded due to safety concerns in being able to understand testing instructions.
Parent-Led Cognitive-Behavioral Teletherapy for Anxiety in Youth With ASD

This study implements an anxiety-focused, parent-led, therapist-assisted cognitive behavioral teletherapy for parents of youth with ASD and anxiety.

Anxiety disorders affect 50-80% of children with autism spectrum disorder (ASD) and are associated with significant life impairment and worsening trajectory without treatment. The most effective psychotherapy for anxiety in youth with and without ASD is cognitive behavioral therapy (CBT), but many families are not able to access CBT due to the cost, practicalities of attending treatment sessions, and limited availability of trained therapists. Alternative models of service delivery are greatly needed, with particular promise of parent-led therapist-assisted (PLTA) models and telehealth delivery formats. Parents may benefit from additional information regarding how to optimize the delivery of CBT for youths with ASD given the potential impact of ASD symptomology on core CBT skills. Thus, this project aims to improve access to anxiety-focused Parent-Led Therapist-Assisted CBT for parents of youth with ASD. Parent-led low-intensity treatment models can improve accessibility, efficiency, and mental health treatment cost. Lower intensity treatment models provide a treatment option that is less costly and burdensome for parents; it is understood that some individuals will respond to the first step and others will require additional treatment to achieve anxiety reduction. However, understanding how many families, and which families, can benefit from a lower intensity model has dramatic benefits for improving access, allocating more intensive services for those most in need, and reducing barriers (e.g., distance). Thus, this study will examine the effectiveness of two anxiety-focused PTLA CBT telehealth models: 1) low-intensity therapist assistance (LTA) and 2) standard therapist assistance (STA). Overall, this study will provide important information regarding the potential benefits of two different approaches to parent-led interventions for youth with ASD and anxiety when delivered via telehealth.

Eligibility Criteria:
Inclusion Criteria:

* Child is between the ages 7-13 years at consent/assent.
* The child meets criteria for ASD.
* The child meets criteria for clinically significant anxiety and/or OCD symptoms.
* Anxiety and/or OCD is the primary presenting problem.
* One parent/guardian is able and willing to participate.
* The child has a Full Scale and Verbal Comprehension Intelligence Quotient \>70.
* The child is able to communicate verbally.
* Participants must reside in Texas and parents must be in the state of Texas when taking calls.

Exclusion Criteria:

* The child has a diagnosis of lifetime DSM-5 bipolar disorder, psychotic disorder, and/or intellectual disability.
* The child has severe current suicidal/homicidal ideation and/or self-injury requiring medical intervention.
* The child is receiving concurrent psychotherapy for anxiety.
* Initiation of a psychotropic medication less than 4 weeks prior to study enrollment or a stimulant/psychoactive medication less than 2 weeks prior to study enrollment.
Market Research - Acceptability Study for a Range of MCT Products

This is a market research, observational study to evaluate the tolerability and acceptability of MCT supplements for young children and young people with intractable epilepsy, GLUT-1 or PDHD from 3 years to adulthood. Patients with a confirmed diagnosis of a fatty acid oxidation disorder, which requires a specialist diet including MCT will be included in this study


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of epilepsy or a fatty acid oxidation disorder requiring a ketogenic or a specialist diet as part of their treatment, which includes MCT.
* Subjects who are new to or already taking an MCT oil and are willing to try each of the 3 study products for 7 days each. 21 days taking product with 2 days between new product trialled.
* Patients aged 3 years of age to adulthood.
* Written informed consent obtained from patient or parental caregiver.

Exclusion Criteria:

* Presence of serious concurrent illness
* Investigator's uncertainty about the willingness or ability of the patient to comply with the protocol requirements
* Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study.
* Any patients having taken antibiotics over the previous 2 weeks leading up to the study.
* Patients less than 3 years of age.
Tafluprost-Timolol Fixed Dose Combination Non-Inferiority Study Against Concomitant Administrations

The purpose of this study is to compare the efficacy and safety of the preservative-free fixed-dose combination of tafluprost and timolol (FDC) to concomitant administration of tafluprost and timolol.

This study will enroll patients who have ocular hypertension or glaucoma.

The study schedule includes seven visits to the study site and three stages:

* washout of 5 days to 4 weeks depending on current glaucoma medication (if any)
* 6-month study treatment period
* 1-3 weeks post-study period


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or more
* A diagnosis of ocular hypertension or open-angle glaucoma
* Meet specific IOP level at visit 1 (screening)and visit 2 (baseline)
* Meet specific visual acuity score
* Are willing to follow instructions
* Have provided a written informed consent

Exclusion Criteria:

* Females who are pregnant, nursing or planning pregnancy
* IOP greater than 36 mmHg at any time point at screening or baseline
* Diagnosis of angle-closure glaucoma or secondary glaucoma other than capsular or pigmentary glaucoma in either eye
* Suspected contraindication or hypersensitivity to study medications tafluprost or timolol (e.g. asthma, low pulse) or to wash-out medication brinzolamide
* Glaucoma filtration surgery or any other ocular surgery (including ocular laser procedures) within 6 months prior to Screening
* Use of contact lenses at Screening or during the study
* Presence of any abnormality or significant illness that could be expected to interfere with the patient safety or study parameters
* Current participation in another clinical trial within the last 30 days
ADVAIR® DISKUS® Inhaler (Fluticasone Propionate/Salmeterol) Versus SEREVENT® DISKUS® Inhaler (Salmeterol) For The Treatment Of Chronic Obstructive Pulmonary Disease Exacerbations. ADVAIR® DISKUS® Inhaler and SEREVENT® DISKUS® Inhaler Are Trademarks of the GSK Group of Companies.

This study evaluates the effect of two medicines on COPD (Chronic Obstructive Pulmonary Disease) exacerbations. This study will last up to 56 weeks, and subjects will visit the clinic 10 times. Subjects will be given breathing tests and will record their breathing symptoms daily on diary cards. All study related medicines and medical examinations will be provided at no cost. The two drugs used in this study have been approved by the FDA for use in patients with COPD.

A Randomized, Double-Blind, Parallel Group, 52-week Study to Compare the Effect of the Fluticasone Propionate/Salmeterol DISKUS® inhaler Combination Product 250/50mcg twice daily (BID) with Salmeterol DISKUS® inhaler 50mcg BID on the Annual Rate of Moderate/Severe Exacerbations in Subjects with Chronic Obstructive Pulmonary Disease (COPD)

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of COPD (chronic obstructive pulmonary disease).
* Current or previous cigarette smokers with a smoking history of at least 10 pack-years.
* History of a least 1 COPD exacerbation in the 12 months prior to screening.
* Forced expiratory volume in one second (FEV1) of less than or equal to 50% of predicted normal.

Exclusion Criteria:

* Current diagnosis of asthma.
* Additional respiratory disorders other than COPD (eg, sarcoidosis, alpha-1 antitrypsin deficiency, cystic fibrosis, or active tuberculosis).
* Concurrent use of long-acting beta-agonists, long-acting anticholinergics, inhaled and oral corticosteroids, theophylline, investigational medications, ritonavir, and anti-leukotrienes.
* Lung resection surgery within 1 year of screening.
* Abnormal and clinically significant ECG findings at screening.
* Other inclusion and exclusion criteria will be evaluated at the first study visit.
Vitamin A Equivalence of Plant Carotenoids in Children

Our objectives will be to test the following hypotheses and to make the following determinations: (1) The absorption and bio-conversion of provitamin A carotenes taken by children are different between spinach, Golden Rice, and ß-C in oil capsules. (2) The absorption of provitamin A carotenes and their bioconversion to vitamin A are different in children with or without adequate vitamin A nutrition. (3) To define the vitamin A equivalence(s) of dietary spinach, Golden Rice, and a ß-C in oil dose by using an isotope reference method in children with or without adequate vitamin A nutrition and to compare those values with values derived from model based compartmental analysis. (4) To determine the number and time of blood samples needed for future studies in various field settings on the retinol equivalence of a large number of plant sources.

This project is to determine the vitamin A value (equivalence) of dietary provitamin A carotenes from spinach, Golden Rice, and pure ß-carotene (ß-C) in oil. These experiments will be conducted in children (ages 6-8) with/without adequate (marginal deficiency) vitamin A nutrition. As plant provitamin A carotenoids are a major and safe vitamin A source for a vast population in the world, it is essential to determine the efficiency of provitamin A carotenoid (mainly ß-C) conversion to vitamin A. By introducing ß-C into rice endosperm, Golden Rice may directly benefit consumers by providing vitamin A nutrition. Our investigation uses hydroponically grown, deca-deuterium labeled spinach and Golden Rice, synthetic ß-C-d10 and a vitamin A isotope reference, C13 labeled retinyl acetate (13C10-RAc), to evaluate the bioavailability and the bioconversion of plant provitamin A carotenes to retinol as compared with ß-C in oil capsules in vivo.

Seventy-two children each will take two meals, breakfast containing 13C10-RAc dose (0.5mg in 0.2g oil capsule) and lunch containing spinach containing 1 mg ß-C (along with white rice), or Golden Rice containing 0.5mg ß-C (along with light colored vegetables), or ß-C oil capsules containing 0.5 mg ß-C in 0.2g oil (along with white rice and light colored vegetables) on the first day of the study. Blood samples will be collected at 1 3, 7, 14, and 21 days after the study doses.

The enrichment of labeled ß-C and labeled retinol in human circulation will be determined using advanced liquid chromatography / mass spectrometry and gas chromatography / mass spectrometry. Through the applications of these novel technologies, we will be able to determine the relative biological activities of endogenous carotenoids; that is, the vitamin A value of spinach, Golden Rice, and ß-C in oil capsules for children with/without vitamin A malnutrition.

This study will be of importance in planning vitamin A deficiency prevention strategies and also will provide useful information regarding the potential efficacy of a bioengineered crop to provide vitamin A nutrition.

Eligibility Criteria:
Inclusion Criteria:

* healthy children

Exclusion Criteria:

* food allergy
* parasitic infection
Comparison Between Inhalation and Intravenous Induction of Anaesthesia During Interventional Mitral Valve Repair

The induction of anaesthesia is one of the most critical situations for high-risk-patients undergoing interventions surgery. For several reasons, it is crucial to maintain adequate blood pressure and cardiac output during this phase.

This retrospective cohort study aims to find out if the choice of the induction agent has a major impact on blood pressure and the use of catecholamines during the induction and the interventional procedure in patients undergoing interventional mitral valve repair.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing elective interventional mitral valve repair
* Sevoflurane or etomidate have been used for induction of anesthesia

Exclusion Criteria:

* Pregnancy
The Relative Prevalence and Severity of Autonomic Nervous System Dysfunction

The purpose of this study is to measure the prevalence and severity of cardiac autonomic neuropathy (CAN), diabetic autonomic neuropathy (DAN) which in non-diabetics is termed advanced nervous system (ANS) dysfunction, and autonomic dysfunction as well as the overall sympathovagal balance (SB) in the CEFH population of diabetic patients versus non-diabetic patients undergoing elective vitreoretinal surgery.

The purpose of this study is to measure the prevalence and severity of cardiac autonomic neuropathy (CAN), diabetic autonomic neuropathy (DAN) which in non-diabetics is termed advanced nervous system (ANS) dysfunction, and autonomic dysfunction as well as the overall sympathovagal balance (SB) in the CEFH population of diabetic patients versus non-diabetic patients undergoing elective vitreoretinal surgery.

Eligibility Criteria:
Inclusion Criteria:

* Type I and Type II Diabetic patients 19 or older who are scheduled for elective surgery to improve vision impaired by diabetic retinopathy
* Patients scheduled during the same time period without diabetes for retinal surgery will serve as an age and gender matched reference group to undergo the non-invasive ANS testing on the day of surgery

Exclusion Criteria:

* Inability to stand will only do baseline, deep breathing and Valsalva portions (A-D) of the testing as described in section 8.1
* Patients with syncope on standing will only do portions A-D of the test
* Inability to cooperate with deep breathing and Valsalva
* Tracheoscopy or otherwise not able to perform a Valsalva
* Not desiring to participate after informed consent
* Known history of idiopathic dysautonomia
* Pulmonary difficulties associated with hyperventilation, including acute URI
* Pacemaker dependent
* Persistently high intraocular pressure despite treatment
* Atrial fibrillation
* Ventricular arrhythmias greater than 10 beats per minute
* Taking MAO inhibitors
Assessing Patient-Reported Experience of Care for Home Dialysis (ASPIRED)

Home dialysis modalities, including peritoneal dialysis (PD) and home hemodialysis (HHD), represent alternatives to conventional in-center hemodialysis (HD) that for some patients may be better aligned with preferences regarding the integration of dialysis treatments into their lives. Assessment of patient experience and satisfaction with care among individuals undergoing maintenance dialysis in the United States is a national health care priority and mandated by Congress. While validated instruments (ICH CAHPS) are in use to assess patient experience with in-center HD, currently no validated instruments are available to measure patient-reported experience in home dialysis.

This Home Patient Experience Survey Validation Study is an in-house research study conducted in partnership with the University of Washington.

Assessment of patient experience and satisfaction with care among individuals undergoing maintenance dialysis in the United States is a national health care priority and mandated by Congress. No validated instruments are available to measure the patient-reported experience of care in-home dialysis patients. Such tools are needed as more patients are expected to choose home dialysis therapies in the future. This study aims to validate a home patient experience survey instrument.

This is a cross-sectional validation to determine the measurement properties of a new home dialysis patient experience survey instrument. Satellite Healthcare home dialysis patients will be approached by mail or by phone to complete the survey.

The aim of this study is to perform field testing for this newly developed instrument for the purposes of instrument validation and to determine survey instrument measurement properties. This will include the evaluation of any multi-item scales as well as an overall score.

Eligibility Criteria:
Inclusion Criteria:

* Patients receiving care for home dialysis at a facility that provides care for \>= 3 patients at the time of cohort identification.

Exclusion Criteria:

* Age \< 18 years
* Patients receiving care for home dialysis at the facility for less than 3 months
* Institutionalized (senior nursing facility/multi-resident facility) or Hospice care patients
Clinical Trial to Evaluate the Effect of an Extract of Sclerocaya Birrea on Prediabetic Subjects

It consists in the intake, during a period of 10 weeks, of a nutraceutical (natural extract of Sclerocarya birrea). It is a clinical trial, during which certain parameters of the glucidic metabolism will be measured analytically. Other secondary variables such as lipid profile, inflammatory markers, blood pressure, endothelial function and body composition will also be determined.


Eligibility Criteria:
Inclusion Criteria:

* Age: 18-65 years.
* Diagnosis of prediabetes according to the American Diabetes Association.

  * Altered fasting glucose (95-125 mg / dl).
  * Glucose intolerance (oral glucose tolerance test with glycemia at 2 hours between 140 - 199 mg / dl).
  * Hemoglobin glycated between 5.7 and 6.4%.
* Subjects with body mass index between 18-35 Kg / m2.
* Stable food habits: there is no gain or weight loss of more than 5 kg in the ten weeks.
* I do not consume foods rich in Screrocaria Birrea.

Exclusion Criteria:

* Subjects with a history of any type of liver or kidney pathology.
* Use of medications that may interfere with glucose metabolism.
* Consumption of alcohol greater than 20 g / day.
* History of allergic hypersensitivity or poor tolerance to any component of the products under study.
* Participation in another clinical trial in the three months prior to the study
* Lack of will or inability to comply with clinical trial procedures.
* Pregnancy.