cyrilzakka/clinical-trials huggingface dataset:
Clinical Performance of BioCLIA Ro60

The study is to evaluate the clinical performance of BioCLIA Ro60 for measuring the autoantibody in autoimmune disease patients.

100-200 clinically-diagnosed disease samples, as well as approximately 300 samples of various control diseases, will be used in the study. The specimen will be collected as the clinically leftover samples that have been used for routine clinical diagnosis purpose or research purpose, and with de-identification methods. Each set of samples will also be tested on a control serologic Anti-Ro60 detection kit, QUANTA Flash Ro60. Clinical sensitivity and clinical specificity will be analyzed for, also a method comparison conclusion will be drawn by comparing the two methods.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with relevant diseases, including Systemic lupus erythematosus (SLE) and Sjogren's syndrome (SS)
* Or diagnosed with other control diseases, including Rheumatoid arthritis (RA), Infectious diseases and others

Exclusion Criteria:

* Treatment with medicine that submerge the autoantibody concentration to non-detectable range
* Co-diagnosed with multiple relevant diseases (e.g., SLE / SS) and/or control diseases
* Hemolyzed sample.
THERMOCOOL® SMARTTOUCH™ Registry

The primary purpose of this registry is to obtain "real world" clinical use of contact force measurements during ablation procedures.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with symptomatic atrial fibrillation (AF) who, in the opinion of the investigator, are candidates for ablation for atrial fibrillation. Candidates who have had previous ablation procedures may be included in the registry
* Subjects who have failed at least one antiarrhythmic drug (AAD)(class I or III, or AV nodal blocking agents such as beta blockers and calcium channel blockers) as evidenced by recurrent symptomatic atrial fibrillation, or intolerable to the AAD.
* Subjects must be 18 years of age or older
* Subjects must be able and willing to comply with all pre-, post and follow-up testing and requirements
* Subjects must provide written informed consent to participate in the registry

Exclusion Criteria:

* Significant congenital anomaly or a medical problem that in the opinion of the investigator would preclude enrollment in this registry
* History of blood clotting or bleeding abnormalities or contraindication to anticoagulation (heparin, warfarin, or dabigatran)
* History of a documented thromboembolic event within the past year
* Significant pulmonary disease (eg, restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease)or any other disease or malfunction of the lungs or respiratory system that produces chronic symptoms
* Previous cardiac surgery (eg, CABG) or valvular cardiac surgical procedure (eg, ventriculotomy, atriotomy, valve repair or replacement, presence of a prosthetic valve)
* Awaiting cardiac transplantation or other cardiac surgery within the next 360 days (12 months)
* Diagnosed atrial myxoma
* Unstable angina
* Uncontrolled heart failure Uncontrolled heart Failure or NYHA Class III or IV heart failure
* Acute illness, active systemic infection, or sepsis
* Any other disease or malfunction that would preclude treatment with ablation in the opinion of the investigator
Affective Processing in Depression and Epilepsy

The goal of this study is to determine whether there are unique markers on neuroimaging that are associated with depression in epilepsy.

Symptoms of depression is commonly seen in patients with epilepsy. There are similarities and differences between depressive symptoms in epilepsy when compared with primary depression. Through the use of fMRI (Functional MRI), we hope to determine whether there are unique markers on neuroimaging that are associated with depression in epilepsy.

Eligibility Criteria:
For Control Group

Inclusion Criteria:

* Healthy adults of 18 years of age or older.

Exclusion Criteria:

* Subject has no history of affective disorders
* Subject scores higher than 5 on Hamilton Depression Rating Scale
* Subject with prior primary diagnosis of any psychotic disorder, bipolar disorder, anxiety disorder, or any other serious medical or neurological disorder
* Subject is pregnant
* Subject is unable to undergo a MRI

Epilepsy Only Group

Inclusion Criteria:

* Subject is at least 18 years of age
* Subject has confirmed temporal lobe epilepsy (TLE)

Exclusion Criteria:

* Subject has a history of depression
* Subject scores higher then 5 on Hamilton Depression Rating Scale
* Subject with prior primary diagnosis of any psychotic disorder, bipolar disorder, anxiety disorder, or any other serious medical or neurological disorder
* Subject is pregnant
* Subject is unable to undergo a MRI

Depression Only Group

Inclusion Criteria:

* Subject is at least 18 years of age
* Subject scores between 12 and 18 on Hamilton Depression Rating Scale

Exclusion Criteria:

* Subject scores higher than 18 on Hamilton Depression Rating Scale
* Subject is currently being medicated for depression
* Subject has history of major depression or dysthymia
* Subject with prior primary diagnosis of any psychotic disorder, bipolar disorder, anxiety disorder, or any other serious medical or neurological disorder
* Subject is pregnant
* Subject is unable to undergo a MRI

Depression and Epilepsy Group

Inclusion Criteria:

* Subject has confirmed temporal lobe epilepsy (TLE)
* Subject scores between 12 and 18 on Hamilton Depression Rating Scale

Exclusion Criteria:

* Subject has history of major depression or dysthymia
* Subject is currently on medication for depression
* Subject with prior primary diagnosis of any psychotic disorder, bipolar disorder, anxiety disorder, or any other serious medical or neurological disorder
* Subject is pregnant
* Subject is unable to undergo a MRI
Sequential Therapy (FK506 + Monoclonal Anti-IL2R Antibodies + MMF) Versus FK506 With Steroids in Liver TX

Study to evaluate the benefits and any risks of the delayed administration of tacrolimus in a combined regimen of mycophenolate mofetil and monoclonal anti-IL2R antibodies (daclizumab), in comparison with a standard steroid + tacrolimus double drug regimen


Eligibility Criteria:
Inclusion Criteria:

* Patient is undergoing orthotopic liver allograft transplantation. This includes partial organ transplantation. Age of donor between 5 and 65 years

Exclusion Criteria:

* Patient has previously received or is receiving an organ transplant (including liver re-transplantation)
* Recipient of an auxiliary graft or in which a bio-artificial liver has been used
* Patient is receiving a living related liver transplantation
* Patient is requiring steroids as well as chemotherapy prior to transplantation
* Patient having any previous history of neoplastic disease of any type (including leukaemia). However, patients with primary liver carcinoma can be included if they meet the following criteria:

  * \> 3 nodes
  * No node larger than 5 cm
  * No metastases
  * No vascular invasion
Relationship Between Dysphonia And Anxiety In Fibromyalgia

Our aim in conducting this study is to determine the relationship between voice disorders and anxiety in patients with fibromyalgia syndrome (FS).

This case controlled study was performed at the Physical Medicine and Rehabilitation outpatient clinic between April 2022 and June 2022. 25 patients who were diagnosed with FS according to the 2010 American College of Rheumatology (ACR) criteria were included in the study. For the control group 25 healthy volunteers with no previous chronic disease history were included . The investigators planed to investigate the relationship between the anxiety level of the FS patients and dysphonia. Thus an acoustic voice analysis (fundamental frequency (F0), jitter, shimmer, noise to harmonic ratio (NHR), harmonic to noise ratio (HNR)) and an aerodynamic analysis (maximal phonation time (MPT)) were performed by an experienced otolaryngologist specialized in voice disorders for evaluation of objective voice quality and function. These analyses were performed on all the volunteers from both groups, and the results obtained were compared between the groups.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with Fibromyalgia syndrome for at least 1 year
* Minimum VAS score of 3

Exclusion Criteria:

* Patients with diabetes mellitus,
* other rheumatological diseases,
* malignancies,
* connective tissue disorders
* neuromuscular diseases and
* hereditary diseases.
Effects of Fluid Milk in Attenuating Hyperglycemia and Hypertriglyceridemia After Meal

Epidemiological studies indicate that risk of type 2 diabetes is lower when milk is consumed in the regular diet. Milk products are unique in that they produce high insulin response despite their low glycemic index. The general aim of the proposed study is to determine the effect of fluid milk on attenuating the postprandial surge in plasma glucose and triglyceride after meals and its associated physiological mechanisms. The investigators hypothesize that the consumption of one or two servings of non-fat milk added to a standard oral glucose tolerance test (OGTT) solution or the high fat tolerance test meal will attenuate postprandial hyperglycemia and triglyceridemia. The investigators hypothesize that the postulated improvement in postprandial metabolic response due to the consumption of fluid milk will be associated with increased postprandial insulin secretion as well as insulin-mediated endothelial vasodilation and whole-limb perfusion.

A double blind randomized placebo-controlled crossover experimental design with six treatments will be used. A total of 30 young (20-40 year old) healthy men and women will serve as subjects. Following 2 days of physical activity and dietary control, subjects will consume a standard OGTT load or high fat tolerance load on the morning of Day 3. The solution used in the meals will be mixed with one or two servings of non-fat milk or placebo (either carbohydrate matched or total calorie matched). Before and after the test meals are consumed, blood samples will be obtained for later analysis of glucose, triglycerides, insulin, and inflammatory cytokines and brachial artery flow-mediated dilation and femoral artery vascular conductance will be measured. The present research project should provide new and clinically useful insight into the role of conventional dairy products on metabolic homeostasis. If the working hypotheses are supported, the information could be used as an initial/preliminary basis for recommendations for the consumption of fluid milk in the prevention of metabolic diseases.

Eligibility Criteria:
Inclusion Criteria:

* Apparently health, sedentary. All subjects will have a BMI of 25-35 kg/m2.

Exclusion Criteria:

* Candidates who are taking cardiovascular-acting drugs will not be eligible for participation. Subjects with significant intima-media thickening, plaque formation, characteristics of atherosclerosis, metabolic diseases, gastrointestinal disorders, and/or renal disease will be excluded from the study. Additional exclusion criteria will be cow milk allergy or lactose intolerance, pregnancy or lactation, and alcohol abuse.
Assessment of Intellectual Abilities for Subjects With Velopharyngeal Incompetence and Their Impact on Speech Intelligibility

To Assess effect of intelligence on speech production on subjects with velopharyngeal incompetence Search if there is any relation between congenital Velopharyngeal incompetence and decrease IQ of patients

Speech production is a complex process by which thoughts are generated into spoken utterances. Production involves the selection of appropriate words and the appropriate form of those words from the lexicon and morphology, and the organization of those words through the syntax. Then, the phonetic properties of the words are retrieved and the sentence is uttered through the articulations associated with those phonetic properties.

The term intelligibility refers to 'speech clarity' or the proportion of a speaker's output that a listener can readily understand.

Velopharyngeal Incompetence (VPI) refers to any situation in which an individual is unable to completely close the nasal airway during speech. The velopharyngeal mechanism is comprised of a complex group of structures that act in unison to control airflow through the nose and mouth by elevation of the soft palate and constriction of both the lateral and posterior pharyngeal walls. Any disruption in this mechanism may result in abnormal, poorly intelligible speech. VPI can manifest as hypernasality, nasal emission, decreased vocal intensity, and/or facial grimacing.

Intellectual ability refers to the skills required to think critically, see connections between disciplines and problem solve in new or changing situations. Memory, creative problem solving and vocabulary also contribute to the level of an individual's intellectual ability.

Orofacial clefts (OFCs) are frequently occurring human birth defects that have a complex, multifactorial etiology. Though structural orofacial defects are often surgically corrected during infancy and early childhood, OFC patient cohorts are at high risk for neurobehavioral problems including learning disability, impaired language function, psychosocial adjustment issues, and persistently reduced academic achievement.

Eligibility Criteria:
Inclusion Criteria:

* children with cleft lip and palate primary or secondary repaired
* Velopharyngeal incompetence due to any cause especially short palate and deep pharynx
* children above 3 years

Exclusion Criteria:

* Hearing impairment
* Neurological disease
* ADHD
Cost Effectiveness and Efficacy of Kyphoplasty and Vertebroplasty Trial

Randomized trial comparing cost effectiveness and efficacy of kyphoplasty vs vertebroplasty for the treatment of painful, osteoporotic vertebral compression fractures.


Eligibility Criteria:
* \> or = 50 years of age
* Compression fracture (T4-L5)within previous 12 mo.
* Pain from compression fracture
* No malignant tumor
* No back surgery
The Effect of Two Distraction Methods on the Level of Pain, Fear and Anxiety in Children

The aim of this study is to determine the effect of watching cartoons with virtual reality glasses and tablets applied during the blood collection process on the level of pain, fear and anxiety experienced by children.

Needle procedures applied to children for diagnosis and treatment cause fear, anxiety, and pain. In cases where children's pain and fear cannot be controlled, health professionals and parents may experience feelings of stress, helplessness, and guilt. Many approaches reduce pain and anxiety in children during painful procedures. The most commonly used of these approaches is the distraction technique, also known as the distraction technique, which is constructed with cognitive and behavioral processes. There are many methods used to divert attention. Some of those; watching cartoons, inflating balloons, creating balloons by blowing foam, directing techniques, parent coaching, using virtual reality (VR) glasses, listening to music, kaleidoscope, and using distraction cards. The research is a randomized controlled experimental study designed to determine the effects of two different methods (watching 360-degree cartoons with virtual reality glasses and watching cartoons with a tablet) during the blood collection procedure in children, on the level of pain, fear, and anxiety experienced by children.

Eligibility Criteria:
Inclusion Criteria:

* The child and family agree to participate in the research,
* The child is between the ages of 5-12
* The child does not have a chronic and mental health problem.
* Not having a visual and hearing disability
* No history of sedative, analgesic or narcotic substance use within 24 hours before admission
* Not having a febrile illness at the time of application
* Absence of a disease causing chronic pain
* Being treated in the green area according to the 3-level (red-yellow-green) triage system.
* Performing the operation at once

Exclusion Criteria:

* • The child and family's refusal to participate in the research

  * Having a visual and auditory problem
  * The child is less than 5 years old or older than 12 years old
  * The child has a chronic and mental health problem
  * Being treated in the red or yellow area according to the 3-level (red-yellow-green) triage system.
Bacterial Contamination of Workwear

Governmental agencies in the United Kingdom and Scotland have recently instituted guidelines banning physicians' white coats and wearing of long-sleeved garments to decrease hospital transmission of bacteria. The purpose of this study is to compare the bacterial contamination of physicians' white coats with that of newly laundered, standardized short-sleeved uniforms after an eight-hour workday and to determine the rate at which bacterial contamination of the uniform ensues. Our hypothesis was that the physician white coat would have more bacterial contamination at the end of the work day.

Governmental agencies in the United Kingdom and Scotland have recently instituted guidelines banning physicians' white coats and wearing of long-sleeved garments to decrease nosocomial transmission of bacteria. Our goal was to compare the degree of bacterial and methicillin-resistant Staphylococcus aureus contamination of physicians' white coats with that of newly laundered, standardized short-sleeved uniforms after an eight-hour workday and to determine the rate at which bacterial contamination of the uniform ensues. 100 interns, residents, and hospitalists on an internal medicine service were randomized to wear either physician white coat or newly laundered, short-sleeved uniform. Bacterial colony counts and the frequency with which methicillin-resistant Staphylococcus aureus was found was compared in the two groups and over time. Our initial hypothesis was that physician white coats would have more bacterial contamination at the end of the work day.

Eligibility Criteria:
Inclusion Criteria:

* Internal medicine interns, residents, and hospitalists working on acute medicine ward service.

Exclusion Criteria:

* Not willing/unable to participate in study
* Not working a full 8 hour day in the hospital
An Open-Label Study to Evaluate the Effect of Every Other Week PROCRIT� (Epoetin Alfa) Dosing (40,000-60,000 Units) On Maintaining Quality of Life and Target Hemoglobin Levels in Anemic HIV-Infected Patients (CHAMPS II)

The objective of this study was to treat anemic (Hemoglobin (Hb) \< 12 g/dL) HIV-infected subjects with once weekly (QW) PROCRIT (Epoetin alfa) to a target Hb of \> 13 g/dL and then to assess if the target Hb level and improvements in Quality of Life (QOL) could be maintained with every other week (Q2W) PROCRIT (Epoetin alfa) dosing.

This was a Phase IV, open-label, non-randomized, multi-center study conducted in community based practices, physicians networks, or academic institutions in the US. This study included anemic (Hb \< 12 g/dL) HIV-infected subjects and HIV/hepatitis C (HCV) co-infected subjects not receiving HCV treatment on a stable anti-retroviral therapy (ART) regimen for at least 4 weeks prior to enrollment.

Quality of life assessments, laboratory results, and transfusion information were obtained during the study. Laboratory tests, vital signs (blood pressure), and incidence and severity of adverse events were collected and assessed.

The primary objective of this study was to assess if every other week PROCRIT (Epoetin alfa) dosing can maintain quality of life in anemic HIV-infected patients. The primary hypothesis of interest was that the mean quality of life score (as measured by MOS-HIV General Health Perception score) at the end of the every other week (Q2W) maintenance phase was not lower than that at the beginning of the maintenance phase by more than 7 points.

It was anticipated that less frequent dosing, every other week, was more convenient for patients and will improve patient compliance. The starting dose (Baseline/Study Day 1) of PROCRIT (Epoetin alfa) for all eligible subjects was 40,000 U given subcutaneously QW. The maximum duration was 24 weeks. Subjects who achieved target Hb levels \>= 13 g/dL were converted to a maintenance dose of PROCRIT (Epoetin alfa) sc Q2W.

Eligibility Criteria:
Inclusion Criteria:

* Understand and sign written informed consent
* HIV-infected patients (as documented by HIV-RNA values)
* HIV/HCV co-infected patients not receiving treatment
* Hemoglobin \< 12 g/dL unrelated to transfusion
* Estimated life expectancy of \> 9 months
* Has been maintained on a stable antiretroviral regimen for at least four weeks prior to enrollment into this study.

Exclusion Criteria:

* Acute, symptomatic opportunistic infection or other acute AIDS defining illness
* Anemia attributable to factors other than HIV infection (i.e., iron, B12 or folate deficiencies, hemolysis, gastrointestinal bleeding)
* HCV co-infected patients who are anticipated to receive treatment with ribavirin/interferon during the study period. Previous treatment with ribavirin/interferon must have been completed at least 12 weeks prior to study entry
* Ferritin level \< 40 ng/mL
* Uncontrolled or severe cardiovascular disease including recent (\< 6 months) myocardial infarction, uncontrolled hypertension or congestive heart failure
OVATIO CRT and SITUS OTW LV Lead Post Approval Study

Post approval study measuring safety outcomes on the Ovatio CRT-D and SITUS OTW LV lead over 5 years.


Eligibility Criteria:
Inclusion Criteria:

* NYHA Class III/IV
* Stable medical regimen
* QRS greater than or equal to 130 ms
* LVEF less than or equal to 35%

Exclusion Criteria:

* VT of transient or reversible causes
* Incessant VT
* Currently implanted with a lead positioned through the coronary sinus (unless it is the SITUS OTW LV lead)
* Cardiac revascularization or angioplasty within the last month
* Heart failure due to correctable valve disease
* Chronic, medially refractory AT
* Enrolled in another clinical study that may confound the results of this study
* Life expectancy less than 6 months
* Inability to understand the purpose of the study or refusal to cooperate
* Inability or refusal to provide informed consent
* Unavailable for scheduled follow-up with the implanting practice
* Sensitivity to 1 mg dexamethasone sodium phosphate
* Less than 18 years of age
* Pregnancy