cyrilzakka/clinical-trials huggingface dataset:
EndoStim Patient Registry

To provide a research tool enabling physicians to monitor long term clinical outcomes for patients undergoing gastroesophageal reflux disease (GERD) treatment with EndoStim LES Stimulation System.

The EndoStim Patient Registry provides a framework for data collection on patients with GERD treated with the EndoStim LES Stimulation System. The primary objective is to provide a tool for participating physician investigators to collect and analyze outcomes data related to the use of the EndoStim LES Stimulation System.

This is a prospective, multi-center patient Registry. Sites may choose to also retrospectively enroll previously treated patients (after obtaining informed consent) and enter retrospective data into case report forms paper or on-line.

Eligibility Criteria:
Inclusion Criteria:

1. Subject meets therapy indications
2. Subject signs informed consent
3. Subject has a planned EndoStim LES Stimulation System implant (prospective) OR subject has already had EndoStim LES Stimulation System implant (retrospective)

Exclusion Criteria:

1. Subject meets therapy contraindications
Association Between Vitamin D and Inflammation and Diabetes Risk in Morbidly Obese Pre-Menopausal Women

Obesity is associated with low-grade inflammation, insulin resistance and low vitamin D status. Vitamin D has traditionally been known to involve in calcium homeostasis and prevent rickets; however, recently it has been recognized to inversely associate with many non-skeletal diseases and conditions including obesity and type 2 diabetes (T2DM). In vitro studies have demonstrated that vitamin D possesses anti-inflammatory properties. It remains unknown if the effect of vitamin D on insulin sensitivity is mediated by suppressing inflammation in human adipose tissues. The main objective of this study was to assess the association between vitamin D and insulin sensitivity and inflammation in morbidly obese pre-menopausal women. Obese women (n=76) were recruited from the University of Illinois at Chicago (UIC) Nutrition and Wellness Center and the UIC medical center bariatric surgery clinics. Insulin sensitivity/resistance was assessed by (1) Oral glucose insulin sensitivity (OGIS) index, derived from dynamic oral glucose tolerance test (OGTT), and (2) Homeostasis model of insulin resistance (HOMA-IR), calculated from fasting steady-state glucose and insulin. Also, to better understand the potential mechanism and the role circulating vitamin D (25OHD) plays in adipose tissue inflammation, we assessed messenger ribonucleic acid (mRNA) expression of vitamin D receptor (VDR) and various inflammatory genes in visceral (VAT) and subcutaneous adipose tissues (SAT) of obese women that underwent a restrictive bariatric procedure. We hypothesized that subjects with higher serum vitamin D levels would be less inflamed and more insulin sensitive and have increased expression of VDR and pro-inflammatory markers compared to those with lower serum vitamin D levels.


Eligibility Criteria:
Inclusion Criteria:

* Premenopausal women between the age of 21 and 49 years old
* BMI \>=35(kg/m2)
* Not pregnant
* English speaking
* Approved for a bariatric surgery

Exclusion Criteria:

Subjects with:

* Diabetes
* Cancer
* Kidney disease
* Liver disease
* Gallbladder disease
* Rheumatoid arthritis
* HIV/AIDS
* Crohn's disease or inflammatory bowel disease
* Subjects taking anti-inflammatory medications
Return to Sport and Functional Performance Following Surgical Intervention for Anterior Glenohumeral Instability

The purpose of this prospective cohort study is to compare patient-reported, clinical, and functional outcomes in patients who have elected to have either the Bankart with Remplissage or Latarjet procedure for the treatment of anterior glenohumeral instability (AGHI) up to 24-months postoperative.

The purpose of this prospective cohort study is to compare patient-reported, clinical, and functional outcomes in patients who have elected to have either the Bankart with Remplissage or Latarjet procedure for the treatment of AGHI up to 24-months postoperative. A secondary objective aims to address rates of return to sport (RTS) and performance in an RTS assessment in athletic patients with anterior glenohumeral instability (AGHI) who elect to undergo either surgical intervention until 24-months postoperative.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 - 50 years
* Documented reduction of anterior shoulder dislocation
* Patient has suffered two or more dislocations of the study shoulder
* Physical examination elicits unwanted glenohumeral translation with reproduction of symptoms
* Glenoid bone loss defined on CT (or MRI) using standardized and reproducible best-fit circle techniques \< 25%
* Able to benefit from surgical intervention

Exclusion Criteria:

* Glenoid defect in the affected shoulder ≥ 25% of the AP diameter of the glenoid
* Previous surgery on affected shoulder (ANY type of shoulder surgery)
* Significant shoulder comorbidities including osteoarthritis or other shoulder conditions including multi-directional instability
* Participant is involved in litigation or a workplace insurance claim (i.e., WCB).
* Confirmed connective tissue disorder (i.e., Ehlers-Danlos, Marfans)
* Beighton hypermobility score of \>6
* Active joint or systemic infection, significant muscle paralysis, rotator cuff tear arthropathy, Charcot's arthropathy, significant medical comorbidity that could alter the effectiveness of the surgical intervention (e.g., Cervical radiculopathy, polymyalgia rheumatica)
* Major medical illness (life expectancy less than 1 year) or unacceptably high operative risk
* Epilepsy
* Any condition that precludes informed consent (i.e. psychiatric illness)
* Unable to speak or read English/French
* Unable or unwilling to be followed for 2 years or complete functional testing
Incidence and Outcomes of Venous Thromboembolism

To identify the incidence cohort of Olmsted County Minnesota residents with deep venous thrombosis (DVT)/pulmonary embolism (PE) from 1966 through 1990. Episodes of DVT or PE acquired during hospitalization or in the community were identified for future studies.

BACKGROUND:

Deep vein thrombosis and pulmonary embolism most often occur during hospitalization for surgery or chronic medical conditions. Consequently information on deep venous thrombosis/pulmonary embolism is derived from large referral hospitals, and there are substantial gaps in our understanding of the incidence, risk factors, and outcomes of deep venous thrombosis/pulmonary embolism in the community. This was one of the first studies to compare hospital acquired deep venous thrombosis/pulmonary embolism with deep venous thrombosis/pulmonary embolism among ambulatory residents in a community.

DESIGN NARRATIVE:

The five part study: 1. identified the incidence cohort and tested the hypotheses that over the 25 year study period the incidence of deep venous thrombosis/pulmonary embolism had decreased, the extent of testing for suspected deep venous thrombosis/pulmonary embolism had increased, and the number of tests obtained for patients with deep venous thrombosis/pulmonary embolism had increased. 2. determined the independent risk factors for deep venous thrombosis/pulmonary embolism and estimated the population attribute risk due to each independent risk factor for deep venous thrombosis/pulmonary embolism in a case-control study of the incidence cohort and community controls. 3. tested the hypothesis that deep venous thrombosis/pulmonary embolism were independent risk factors for death after adjusting for age, sex and co-morbid conditions. 4. described the occurrence of the post-phlebitic syndrome, pulmonary hypertension, and recurrent deep venous thrombosis/pulmonary embolism over the 25 year study period and identified the independent risk factors for lower extremity venous ulceration. 5. evaluated the accuracy of national pulmonary embolism mortality rates by comparing pulmonary embolism mortality rates calculated from a review of all the inpatient and outpatient medical records of Olmsted County deep venous thrombosis/pulmonary embolism patients with death certificate pulmonary embolism mortality rates for Olmsted County from the National Center for Health Statistics. The study provided the most complete and comprehensive population based estimates of the incidence, risk factors, survival and outcomes of deep venous thrombosis/pulmonary embolism available to date.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
TMC649128HPC1001 - First In-human Trial to Examine Safety, Tolerability, and Pharmacokinetics (How the Drug is Absorbed Into the Bloodstream) of Increasing Single Oral Doses of TMC649128 in Healthy Volunteers

The purpose of this study is to assess the pharmacokinetics, safety, and tolerability of single oral doses of TMC649128 in healthy volunteers. Pharmacokinetics (PK) means how the drug is absorbed into the bloodstream, distributed in the body, and eliminated from the body.

TMC649128 will be investigated for the treatment of chronic hepatitis C infection. This is a Phase I, first in humans (no clinical studies have been performed to date), double-blind (neither the participant nor investigator knows whether they receive active or placebo), randomized (study medication is assigned by chance), placebo-controlled study to examine the safety, tolerability, and blood and plasma pharmacokinetics of increasing single oral doses of TMC649128. The single dose escalation will consist of 6 sessions (Sessions I to IV) in 6 panels (Panels 1 to 6) of 9 healthy adult volunteers each. The dose of TMC649128 will be consecutively escalated. In each session, 6 participants will receive TMC649128 and 3 participants will receive placebo, all with standard meals. Each session will have a staggered approach, ie, the first 4 participants will be dosed, followed by at least a 72-hour safety review and if no acute effects are observed, the remaining 5 participants will be dosed. The main focus of the trial is the determination of safety and tolerability of TMC649128 after single oral doses in fed conditions in healthy volunteers, but also the determination of the pharmacokinetic characteristics (level-profile of TMC649128 over time in the blood stream and urine). This evaluation requires multiple blood samples from Day 1 to Day 4. Safety assessments (blood and urine tests, blood pressure, pulse, electrocardiogram, and physical examination) will follow a different schedule and will be performed during each session, up to 4 weeks after the last administration. Safety and tolerability evaluations will be recorded at regular intervals throughout the trial. The single dose escalation will consist of 6 sessions in 6 panels of 9 healthy adult volunteers each. The dose of TMC649128 will be consecutively escalated.

Eligibility Criteria:
Inclusion Criteria:

* Healthy based on a medical evaluation including medical history, physical examination, blood tests and electrocardiogram
* Body Mass Index of 18.0 to 30.0 kg/m² and non-smoker for at least 3 months prior to selection
* Women must be postmenopausal for at least 2 years and/or be surgically sterile.

Exclusion Criteria:

* Infection with Hepatitis A, B or C virus
* infection with the Human Immunodeficiency Virus (HIV)
* History of, or any current medical condition which could impact the safety of the participant in the study
* A positive urine drug test at screening
* History of any drug allergy or clinically relevant skin disease
* Participation in an investigational drug trial or received an investigational vaccine within 30 days prior to intake.
Inspiratory Muscle Training on Diaphragm Thickness, Inspiratory Muscle Pressure and Physical Function

Fatigue of the respiratory muscles is one of the limitations of exercise at high intensity, although the mechanisms that explain it are not yet clear. This fatigue would cause a decrease in physical performance and could limit the functional capacity of the subject. In this sense, it has been shown that specific training of respiratory muscles, especially inspiratory muscles, improves their strength and resistance both in healthy people and in people with pathologies; managing to improve the quality of life and both physical and sports performance. This study, which follows the quantitative method and proposes an analytical, experimental, longitudinal and prospective design (with the aim of conducting a randomized clinical trial), proposes an intervention based on performing a specific training of inspiratory muscles for 8 weeks, taking 30 maximum inspirations at 60% of the PIM (maximum inspiratory pressure), 2 times a day for 5 days a week; with the aim of assessing the effects on inspiratory function, cardiorespiratory fitness when performing a stress test (Harvard step test) and diaphragm thickness measured by ultrasound. 40 healthy subjects between 18 and 25 years old will be recruited and divided into two groups: an experimental group (n = 20) and a control group (n = 20).


Eligibility Criteria:
Inclusion Criteria:

* healthy university students

Exclusion Criteria:

* Suffering or having suffered aortic aneurysm; pneumothorax; rib wall or pulmonary fistulas; recent trauma or surgery to the upper airway or thoracoabdominal; recent myocardial infarction or angina; retinal detachment, glaucoma, or recent eye surgery; increased intracranial pressure (tonsillar wedge, meningocele, hydrocephalus); abdominal hernias and acute middle ear problems.
Post Market Non-Inferiority Study Comparing Triojection® to Discectomy for Lumbar Disc Herniation

The primary objective of this study is to compare the early clinical outcomes following non-surgical treatment with Triojection® to surgical discectomy. Early is defined as less than or equal to 6 months.

The objective of this study is to compare clinical, economic and safety outcomes between Triojection and surgical discectomy. The study will include two follow-up phases: 1) an initial follow-up period during the first 6 months after treatment and (2) a long-term follow-up lasting an additional 18 months (2 years total).

The hypothesis is that over the first six months after treatment, Triojection® will be non-inferior to discectomy with respect to the improvement in leg pain. This will be demonstrated using a non-inferiority margin of 19.4 points on the difference between baseline leg pain score and the average leg pain score recorded at 1 week, 1, 3 and 6 months.

Eligibility Criteria:
Inclusion Criteria

1. Patient is willing to provide informed consent.
2. Clinical and radiographic evidence of one, and only one, symptomatic protruding or extruded disc between L1 and S1.
3. The herniated disc should have a disc height of at least 50% that of the normal adjacent disc levels, as determined by the investigator.
4. The signal intensity of the herniated disc material should be equal or greater than the nucleus pulposus of the herniated disc.
5. The patient must have pain in a dermatomal distribution consistent with their radiographic findings
6. Leg pain greater than or equal to 5 on the NRS scale
7. Symptoms for at least 6 weeks
8. Willingness to complete all follow-up evaluations
9. Patient aged 18-65 years
10. BMI\<40

Exclusion Criteria:

1. Patients with a disc herniation extending past the facet joint
2. Presence of a non-contiguous disc fragment
3. Impairment of bladder/bowel function or motor impairment in the affected leg
4. An epidural steroid injection in the past 2 weeks
5. Previous discectomy, arthroplasty or fusion at any lumbar level
6. In patients with L5-S1 disc herniation, a congenital condition where the L5 vertebral body is either fused to the sacrum or the L5-S1 disc is not fully formed as a normal adult disc.
7. Symptomatic lumbar stenosis or listhesis
8. Symptomatic sacroiliac joint
9. Symptomatic foraminal stenosis due to severe degenerative disc disease
10. History of spinal tumor, fracture or infection
11. Females of childbearing age that are known to be pregnant or wishing to become pregnant during the study
12. Fibromyalgia
13. Active infection
14. Metastatic cancer within the past 5 years
15. Pending litigation against a health care provider
16. More than 3 months of continuous sick leave prior to enrollment.
17. Known drug or alcohol abuse
18. Diagnosed psychiatric disease or psychological distress caused by recent trauma like divorce, death of a member family or loss of a job
19. Patient known to be affected by favism (G6PD deficiency)
Effect of Steroid Injection Which is Added to Percutaneous Trigger Finger Release: a Double-blinded Randomized Controlled Trial.

Background

Present treatment strategies for trigger finger when conservative management including steroid injection was failed include percutaneous or open A1 pulley release, but some people showed prolonged swelling and delay of complete healing.

We aimed to test the hypothesis that an improved outcome can be achieved by employing steroid injection simultaneously with percutaneous release compared with conventional percutaneous release alone

Methods

We designed a double-blind, randomized controlled trial.

Inclusion criteria is the patient who has symptom of trigger finger warranted surgical release after sufficient time of conservative treatment.

Exclusion criteria are as follow: 1) multiple fingers at presentation; 2) Rheumatoid arthritis patients; 3) Pregnant or lactating patients; 4) Younger than 18 years old; 5) Previous surgery history of finger 6); the patients who got steroid injection more than 4 time previously; 7) coagulation abnormality including usage of anti-thrombotic agent.

After power analysis by a statistician, total 40 patients would be required for each group (percutaneous alone group versus percutaneous alone + steroid injection group).

The surgery will be performed by outpatients clinic basis with local injection. Additional steroid injection will be given to half of patients after allocation with randomized selection by permutaed block randomization.

Primary outcome measure is mean fall in pain visual analogue scale (pVAS) and secondary outcome will be proportion of patients with good response (defined as "Perfect" or "much better" as reported by patients).

Follow-up will be conducted 3 weeks and 3 month after index procedure


Eligibility Criteria:
Inclusion Criteria:

* Trigger finger patients who require surgical intervention due to failuer of sufficient time of conservative treatment

Exclusion Criteria:

* Age under 18 years old
* Rheumatoid arthritis patients
* Patients who got steroid injection more than 4 times previously
* Multiple finger affected at presentation
* Previous surgery history
* Any recent trauma history of affected hand
Pilot Study of Atorvastatin and Anakinra in Children With Coronary Artery Abnormalities Secondary to Kawasaki Disease

Kawasaki disease (KD) is the leading cause of acquired heart disease in children in the developed world. Despite available treatment, 25% of children in San Diego County appropriately treated for KD develop coronary artery abnormalities that could lead to complications later in life, including heart attack. Although we can identify children with KD that have these coronary artery abnormalities, there is no approved additional treatment to decrease coronary artery inflammation and arrest or prevent damage to the coronary arteries. Statins, a class of drugs that is known for lowering cholesterol, have also been shown to decrease inflammation in general as well as at the level of the vessel wall. Anakinra, a therapy that blocks the high levels of interleukin 1 (IL1) that leads to inflammation during acute KD, has been shown in the KD mouse model to prevent the development of coronary artery damage. Both of these therapies have been demonstrated to be safe and well-tolerated in KD patients. Therefore, we propose to study the effects of combination therapy with atorvastatin and anakinra in children with acute KD and early coronary artery abnormalities.


Eligibility Criteria:
Inclusion Criteria:

* Acute Kawasaki disease with a Z score of 3 or larger of the LAD or RCA

Exclusion Criteria:

* Taking a CYP3A4 metabolized drug (such as cyclosporine)
Gastrointestinal Microbiome Influence on the Development of Bronchopulmonary Dysplasia

The purpose of this study is to advance our knowledge of the factors that contribute to the development of bronchopulmonary dysplasia (BPD), a chronic lung affecting premature infants. Specifically, the investigators will determine the complexity of the gut microbiota, the genera of the bacteria that naturally live in the gut, and determine if the relative diversity of the gut bacteria is a prognostic indicator of BPD. To accomplish this, the investigators propose to characterize the microbiota of human premature newborns with BPD, then validate this potential mechanism in mice. The investigators will enroll very low birthweight premature infants admitted to the neonatal intensive care units (NICU) at Le Bonheur Children's Hospital and Regional One Health that are at high risk to develop BPD. A cohort of well full term newborns will also be enrolled. Non-invasive stool samples will be obtained weekly over the first month of life. Infants that eventually develop BPD will be paired with infants that did not develop BPD. Stool samples from these infants will be sent for analysis. The investigators expect that reduced complexity of the gut microbiome is associated with BPD. The investigators will model the contribution of reduced microbiome complexity to the risk to develop BPD or death, as well as the association with disease severity. The project investigates important factors leading to the development of BPD, and has the potential to directly translate to therapy for the most significant pulmonary complication of prematurity.


Eligibility Criteria:
Inclusion Criteria:

1. Newborn humans less than 1 week of age with a birthweight less than 1,500 g, or fetuses with impending delivery and estimated birthweight of less than 1,500 grams. No individuals will be excluded on the basis of sex or ethnicity.
2. Parents can understand and comply with planned study procedures.
3. Parents provide assent/permission prior to any study procedures.

Inclusion criteria mothers:

1. The mother's of infants meeting the infant inclusion criteria above.

Exclusion Criteria:

1. Diagnosed immunodeficiency disorder.
2. Currently receiving investigational immunomodulatory, probiotic or antiviral agent.
3. Infants whose mothers meet the exclusion criteria below.

Exclusion criteria mothers:

1. Diagnosed immunodeficiency disorder
2. Currently receiving investigational immunomodulatory, probiotic or antiviral agents
3. Lacking the mental capacity (e.g. due to pain, anesthesia, mental impairment) to provide informed consent for themselves or assent for the participation of their infant.
4. Having an infant that meets the infant exclusion criteria.
A Study To Evaluate The Difference In iPad-Based Cognitive Video Game (Akili Interactive's Project: EVO) Performance In Amyloid-Positive Versus Amyloid-Negative Healthy Elderly Volunteers

The purpose of the study is to evaluate the difference in learning and performance measures associated with repeated use of an iPad video game (Akili Interactive's Project: EVO) in healthy elderly volunteers based on amyloid status.


Eligibility Criteria:
Inclusion Criteria:

* Healthy males and females between the ages of 70 and 80.
* Subjects must have BMI of 17.5 to 32 kg/m2 and total body weight \> 110 pounds.
* Acceptable screening MRI and PET scans that pass quality control requirements.

Exclusion Criteria:

* Co-morbid diagnosis of clinically documented Alzheimer's disease; - Significant cognitive impairment;
* MMSE (mini mental state examination) score \<26