cyrilzakka/clinical-trials huggingface dataset:
Randomized EsophyX Versus Sham / Placebo Controlled TIF Trial: The RESPECT Study

The objective of the study is to evaluate the relative merits, safety and effectiveness of the EsophyX transoral device in performing an advanced TIF procedure in patients with "troublesome symptoms" as defined by the Montreal consensus definition while on PPIs compared with sham and placebo controls.

Primary Effectiveness Endpoint: A clinically significant reduction in GERD symptoms, specifically "Troublesome" regurgitation with or without heartburn assessed by the Reflux Disease Questionnaire (RDQ).

Troublesome symptoms are those which occur a minimum of 2 days a week and are at least moderate in severity.

Secondary Effectiveness Endpoint: The normalization of esophageal acid exposure at 6 months and a clinically significant reduction in PPI usage at 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-80 years
* Dependent upon daily PPIs for \> 6 months
* Troublesome symptoms, specifically heartburn or regurgitation, while on 40 mg of omeprazole or equivalent.

Troublesome heartburn or regurgitation symptoms are those which occur a minimum of 2-3 days a week and are at least moderate in severity.

* Abnormal ambulatory pH study off PPI therapy for 7 days.
* Normal or near normal esophageal motility (by manometry)
* Hiatal hernia axial height is no larger than 2 cm and the transverse dimension should not exceed 2.5 cm
* Patient willing to cooperate with post-operative dietary recommendations and assessment tests
* Signed informed consent

Exclusion Criteria:

* BMI \> 35
* Hiatal hernia \> 2 cm
* Esophagitis Los Angeles grade C or D
* Esophageal ulcer
* Esophageal stricture
* Esophageal motility disorder
* Pregnancy or plans for pregnancy in the next 12 months (in females)
* Immunosuppression
* ASA \> 2
* Portal hypertension and/or varices
* History of previous resective gastric or esophageal surgery, cervical spine fusion, Zenker's diverticulum, esophageal epiphrenic diverticulum, achalasia, scleroderma or dermatomyositis, eosinophilic esophagitis, or cirrhosis
* Active gastro-duodenal ulcer disease
* Gastric outlet obstruction or stenosis
* Severe gastroparesis or delayed gastric emptying confirmed by solid-phase gastric emptying study if patient complains of postprandial satiety during assessment
* Coagulation disorders
* Interprocedural determination of anatomical presentation which in the opinion of the surgeon does not allow safe device introduction.
Performance of Non-Invasive Monitors During ANH

The aim of this study is to assess the responsiveness of the standard minimally invasive hemodynamic monitors used in the operating room to known changes in the intravascular volume status that occur during blood removal and volume replacement with three different standard fluids used during ANH.


Eligibility Criteria:
Inclusion Criteria:

* Those surgical procedures where ANH is included in the surgical plan and consent is obtained

Exclusion Criteria:

* Severe or symptomatic COPD, emphysema, renal, hepatic or coronary artery disease as defined by the American College of Cardiology (Cannon et al., 2001).
* Esophageal pathology (diverticulum, hiatal hernia, esophageal cancer, esophageal surgery), which introduces risks associated with the placement of the esophageal Doppler.
* Ascites.
* BMI \>35
* Pregnancy
D-Serine Monotherapy for Schizophrenia

N-methyl-D-aspartate receptor (NMDAR) agonist, added to classical or atypical antipsychotic medication, has reduced negative, depressive, and cognitive symptomatology. We will be investigating the effect of D-serine, (DSR), a selective and potent NMDAR agonist, as monotherapy for treatment resistant schizophrenics.

40 subjects on stable doses of risperidone will be randomized under double-blind conditions into a treatment group, which will receive D-serine 2100 mg, or a control group, which will continue to receive risperidone. Treatment will continue for 14 weeks.

Symptoms and side effects will be rated biweekly with the CGI, PANSS, BPRS, SAS, AIMS, and UKU. Before and after the trial subjects will undergo neuropsychological assessments. Baseline and post-trial levels of amino acids relevant to glutamatergic neurotransmission (glutamate, glutamine, aspartate, glycine, serine, alanine) will be assessed.

The primary outcome measures of the study will be the PANSS total scores and the positive and negative symptom cluster scores.


Eligibility Criteria:
Inclusion Criteria:

1. DSM-IV criteria for chronic schizophrenia
2. Treatment resistant
3. aged 18-70
4. Two months on stable risperidone dose
5. PANSS positive symptom cluster score \>20
6. PANSS negative symptom cluster score \>22

Exclusion Criteria:

1. Substance abuse
2. Concurrent DSM IV axis I disorder
3. Serious medical disorder
4. Concurrent drug therapy that can obscure the effect of risperidone or DSR.
The Seatbelt Intervention Study

The study will use a randomized controlled design testing the effectiveness of the following intervention: (i) intervener brief intervention (IBI) vs. (ii) Enhanced usual care (EUC). The study will identify children ages 2-14 at a pediatric trauma center. Children and their parents who agree to participate in the study will then complete a screening survey to identify part time seatbelt use. Those who screen positive will complete a more detailed baseline survey and then be randomized to one of two study conditions. At one month, a follow up assessment by telephone will be completed.


Eligibility Criteria:
Inclusion Criteria:

* Children ages 7-14 and their parent or guardian, at a pediatric trauma center
* Child admitted to hospital with diagnosis of injury other than sexual assault and suicide
* Identify as part time seat belt users

Exclusion Criteria:

-
Retrospective Analysis of Treatment Outcomes in Patients With Bacterial Overgrowth Syndrome Diagnosed by D-Xylose Breath Testing

The objective of this study is to compare the efficacy of prokinetics versus antibiotics versus a combination of antibiotics plus prokinetics in the eradication of Small-Intestinal Bacterial Over-Growth Syndrome (SIBO) in those with and without a positive D-xylose Breath Test.

Hypothesis: Patients with SIBO treated with a combination of prokinetics and in particular octreotide and antibiotics will have reduced recurrence rates of SIBO than either therapy given alone.

We want to determine whether treatment with prokinetics such as Octreotide, Azithromycin, Erythromycin or Tegaserod alone, versus antibiotics alone, or combination of antibiotics plus prokinetics results in symptomatic improvement in patients with SIBO (defined by a positive D xylose Breath test).

Eligibility Criteria:
Inclusion Criteria:

* Patients who have had 14 C-D-Xylose Breath test performed in GI Motility Laboratory at the University of Florida

Exclusion Criteria:

* Those who cannot tolerate 14 C-D-Xylose Breath test for any reason
Body Positive Images and Photo Modification Cues on Social Media

The purpose of this research is to explore how women evaluate photos of other women posted on social media sites. There are two factors the investigators plan to explore in an online experiment: (a) the degree to which body positive images appear to be sexualized or not; and (b) whether or not there is evidence of photo modification on these images. The results of this work will provide greater understanding into the effects of the body positive movement and determine conditions under which these campaigns are most impactful.

The purpose of this research is to explore how women evaluate photos of other women posted on social media sites. Specifically, the investigators are interested in providing more nuance regarding the effectiveness of body positive imagery (i.e., more diverse representations of physical attractiveness and empowerment of women underrepresented in the mainstream media). The literature on female objectification suggests women are oftentimes portrayed in unrealistic ways (e.g., ultra-thin and hyper-sexualized) via the mainstream media. Moreover, warranting theory provides predictions about the extent to which online content represents an offline reality. As such, there are two factors the investigators plan to explore in an online experiment: (a) the degree to which body positive images appear to be sexualized or not; and (b) whether or not there is evidence of photo modification on these images. The results of this work will provide greater understanding into the effects of the body positive movement and determine conditions under which these campaigns are most impactful.

Eligibility Criteria:
Inclusion Criteria:

* Adults 18 years of age or older

Exclusion Criteria:

* n/a
Serum Lipid Levels and Other Biomarkers of Cardiovascular Disease in Patients With Psoriasis

Psoriasis patients are known to be at increased risk for heart disease. This may be due to the increased prevalence of cardiovascular disease risk factors in this population, including high blood pressure, diabetes, obesity, and high cholesterol. Although cholesterol levels are known to be altered in psoriasis, most studies have used standard lipid profiles to measure cholesterol. These tests indirectly measure LDL (bad cholesterol) and become less accurate when triglyceride levels are high, as often see in individuals with psoriasis. We have designed a case-control study that uses a more specific and detailed cholesterol test to measure serum lipid levels in psoriasis patients, allowing for more accurate determination of LDL and better assessment of the lipid-contribution to cardiovascular risk. We will also measure other markers of inflammation that may contribute to cardiovascular disease.


Eligibility Criteria:
Inclusion Criteria:

* Adults of both sexes from our dermatology clinic, between the age 18 and 80 years who wish to participate voluntarily in the study and who have signed a written informed consent form to participate. Cases will have a diagnosis of psoriasis as diagnosed by our principal investigator, while controls will be selected from the same dermatology clinic.

Exclusion Criteria:

* Current or past use (within 6-8 weeks) of anti-hyperlipidemic agents (statins, fibrates, neomycin, niacin, ezetimibe) and/or any other medications significantly affecting lipid metabolism, including cyclosporine, acitretin, protease inhibitors, tamoxifen, clozapine, and estrogen replacement therapy.
* Presence of secondary causes of hyperlipidemia including diabetes mellitus, smoking, untreated hypothyroidism, nephrotic syndrome, chronic kidney disease, and cholestatic liver disease (e.g. primary biliary cirrhosis).
* History of cardiovascular disease (e.g. previous myocardial infarction, stroke, or angioplasty performed secondary to atherosclerosis).
* History of alcohol intake \>30 g/day in males and \>20 g/day in females.
* Pregnancy
* Subjects with conditions or diseases hindering data collection and follow up, such as incapacitating diseases, cognitive deterioration, institutionalized patients.
Adjunctive Treatment With Doxycycline to Enhance the Durability of Endovascular Aortic Aneurysm Repair

The durability of endovascular aneurysm repair (EVAR) has been limited by development of endoleaks which may be secondary to progressive aortic degeneration by matrix metalloproteases (MMP). Doxycycline is a known inhibitor of the MMP family of enzymes in aneurysms. The investigators propose a randomized, controlled trial of adjuvant doxycycline therapy with EVAR to determine its effects on re-intervention, aneurysm shrinkage and serum markers of aneurysmal degeneration.

Patients will be consented and enrolled at the time of their clinic visit or admission to the hospital for a planned EVAR, in accordance with institutional review board guidelines. Demographic, risk factor and medication regimen data will be obtained from the patient's clinical chart. Patients will be randomized to doxycycline therapy (100 mg taken twice daily) or a placebo. The patients will receive their first dose of study medication on the day following surgery, and continue the study therapy for 6 months.

Plasma and serum will be obtained at the time of enrollment (baseline), and at each post-operative follow-up visit during the study as outlined above. Aliquots will be stored at -80ºC until assayed. Measurements of the circulating markers will be performed by commercially available assays for plasma MMP-9 (R\&D Systems, Minneapolis, MN), serum IL-6 (R\&D Systems) , IL-8 (R\&D Systems), IFN-gamma (R\&D Systems), and CRP (Bio-Check, Burlingame, CA) Data will be collected from the pre-operative and all post-operative CT scans regarding maximal aneurysm diameter and transverse neck diameter at 5 mm, 10 mm and 15 mm below the takeoff of the lowest renal artery. All documented endoleaks and their clinical type will be recorded, as will any re-intervention related to the graft or aneurysm.

The primary end-points of the study related to aneurysm measurements will be an increase or decrease in any of the diameter measurements of the aorta by 2 mm or more on 2 consecutive CT scans or a change of 5 mm or more on any single scan. Of the circulating markers, an additional primary endpoint will be a 50% reduction in baseline MMP-9 after endografting. Secondary endpoints will be significant reductions over baseline in circulating IL-6, IL-8, IFN-γ, and CRP. An a priori power analysis indicates that at 6 months, reductions in circulating levels of these markers by 50% can be detected with a β-error of less than 0.1 and α-error of less than 0.05.

Eligibility Criteria:
Inclusion Criteria:

* Presence of an abdominal aortic aneurysm (AAA) with a maximum diameter of \> or = 4.5 cm
* Planned aneurysm exclusion with endoluminal stent graft (any brand)

Exclusion Criteria:

* Known malignancy not to include prostate cancer or any history of cancer that has not had a recurrence in the last 5 years.
* Hypersensitivity to doxycycline or any of its components
* Pregnancy
* Ruptured AAA
* Extension of covered portion of the graft above the renal arteries
* Previous endoluminal aneurysm repair
Circuit Training and Retina

The purpose of this research study is to see if high-speed weight training performed in a circuit (using one machine after another) can improve participant heart and brain function, strength, and power in older persons.


Eligibility Criteria:
Inclusion Criteria:

1. 65-90 years of age;
2. Montreal Cognitive Assessment (MoCA) \> 23
3. no memory loss complaints

Exclusion Criteria:

1. Uncontrolled cardiovascular or neuromuscular diseases that prevent participation in a training program;
2. Cerebrovascular disease;
3. Malignancy within the previous 5 years;
4. Documented HIV infection or other immunodeficiency syndrome;
5. Any systemic inflammatory or autoimmune conditions such as rheumatoid arthritis, systemic lupus erythematosus, or other serious concomitant medical illness;
6. A history of ocular surgeries (except for cataract surgery more than 6 months ago) or other ocular diseases;
7. Bilateral moderate or severe cataracts;
8. Refractive errors of myopia, hyperopia and/or astigmatism more than 6.0 Diopters.
Review of Safety Using Rilonacept in Preventing Gout Exacerbations (RE-SURGE)

The purpose of this clinical research study is to determine the safety and effectiveness of an experimental drug called rilonacept in subjects with gout who are on urate-lowering therapy. Subjects will participate in this study for approximately 20 weeks. Rilonacept is being studied for use in preventing gout flares in subjects on urate-lowering therapy.


Eligibility Criteria:
Inclusion Criteria:

* Male or female 18 to 80 years of age;
* Previously met the preliminary criteria of American Rheumatism Associatio (ARA) for the classification of acute gout arthritis of primary gout;
* Subjects with history of gout, initiating or currently on urate lowering; therapy who are at risk of gout flare.

Exclusion Criteria:

* Acute gout flare within 2 weeks prior to the screening visit and during the screening visit;
* Persistent chronic or active infections;
* History of an allergic reaction to allopurinol;
* History or presence of cancer within 5 years of the Screening Visit;;;
The Over The Counter Pill National Study

This is a prospective cohort study of individuals purchasing the oral contraceptive pill over the counter (OTC) in pharmacies in 32 US states. The comparison group is people receiving a prescription (Rx) for oral contraception. Both groups will be followed for one year to examine contraceptive continuation rates. This study will also identify who is using the pill OTC and why and evaluate differences in pregnancy intention and measures of contraceptive agency between the two groups.


Eligibility Criteria:
Inclusion Criteria:

* Capable of pregnancy
* Purchasing oral contraception at a participating pharmacy

Exclusion Criteria:

* Using the pill for non contraceptive indications
viTAmin K2 and rEcOVery From ExeRcise

The aim of the current study, therefore, is to investigate the effects of vitamin K2 supplementation on the physiological responses to an acute bout of resistance exercise.


Eligibility Criteria:
Inclusion Criteria:

* Participant is able and willing to sign the Informed Consent From
* No plans to change lifestyle (activity and nutrition) during the study period
* Older group (n=40): 65 years of age or older.
* Younger group (n=40): Aged 18-40 years

Exclusion Criteria:

* Not currently, or in the last year, participating in more than 1h per week of vigorous aerobic physical activity or any resistance exercise
* BMI \> 30 kg/m2
* diabetes
* severe cardiovascular disease
* seizure disorders
* liver disease
* uncontrolled hypertension (\>150/90mmHg at baseline measurement)
* cancer or cancer that has been in remission \<5 years
* ambulatory impairments which would limit ability to perform assessments of muscle function
* dementia
* currently taking Vitamin K2 supplements
* currently taking Vitamin K antagonists/anticoagulants (e.g. warfarin)
* current smoking
* history of drug abuse
* taking medication known to affect muscle (e.g. steroids).
This Phase II/III, Multicenter Study is Designed to Evaluate the Safety and Clinical Activity of AL3810 in Patients

Phase II Study is to Evaluate the Safety and tolerability of AL3810 in combination with carboplatin plus (+) etoposide in untreated participants with ES-SCLC.

Phase III Study is to Evaluate the efficacy of AL3810 in combination with carboplatin plus (+) etoposide in untreated participants with ES-SCLC.


Eligibility Criteria:
Inclusion Criteria:

* Signed Informed Consent Form
* Male or female, 18 \~75years of age
* Eastern Cooperative Oncology Group(ECOG) performance status of 0 or 1
* Histologically or cytologically confirmed ES-SCLC
* No prior treatment for ES-SCLC
* Measurable disease, as defined by RECIST v1.1
* Adequate hematologic and end organ function.
* Serum pregnancy test in screening period for women of childbearing potential should be negative.Except for women who have a history of sterilization or are postmenopausal.Men or woman subjects of reproductive age and their partners must agree to use effective contraception for at least 6 months from the date of signing the Informed Consent Form(ICF) until the last dose of the investigational therapy.

exclusion criteria: main exclusion criteria

* Histologically confirmed mixed small cell lung cancer.
* Symptoms related to central nervous system(CNS) metastasis, unstable CNS metastasis, or CNS diseases needed the increase of steroid dosage to control.
* Uncontrolled hypertension.
Superficial Cervical Plexus Block for Pacemaker Insertion

The purpose of this study is to investigate clinical outcomes from two current standard of care pain control procedures performed for patients undergoing pacemaker insertion.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-100 years old
* Registered patients at Mayo Clinic in Florida scheduled to undergo primary insertion of pacemaker

Exclusion Criteria:

* Emergency placement of pacemaker
* Sub-pectoral placement of pacemaker
* Patients with history of chronic pain
* Patients with anatomical abnormality or disruption to the pacemaker insertion site or site of block placement
* Patients with allergy to local anesthetic
CKD-828 Telmisartan Non-Responder Trial

The aim of the present study is to evaluate the efficacy and safety of two dose combination of Telmisartan/S-Amlodipine (40/2.5mg and 40/5mg) compared with telmisartan monotherapy (80mg) in hypertensive patients inadequately controlled by telmisartan monotherapy.


Eligibility Criteria:
Inclusion Criteria:

* age 18 years or older
* diagnosis of essential hypertension and blood pressure not adequately controlled(inadequate control defined as seated diastolic blood pressure(DBP)\>= 90mmHg if on existing antihypertensive treatment of seated DBP \>= 100mmHg if treatment naive)
* failure to respond to four weeks treatment with telmisartan 40mg(failure to respond defined as seated DBP \>= 90mmHg)
* willing and able to provide written informed consent

Exclusion Criteria:

* mean seated DBP \>= 120mmHg and/or mean seated SBP \>= 200mmHg during run-in treatment or mean seated DBP \>= 120mmHg and/or mean seated SBP \>= 180mmHg at the randomization visit
* known or suspected secondary hypertension(ex. aortic coarctation, Primary hyperaldosteronism, renal artery stenosis, pheochromocytoma)
* has severe heart disease(Heart failure NYHA functional class 3, 4), unstable angina or myocardial infarction, arrhythmia within the past three months
* has cerebrovascular disease as cerebral infarction, cerebral hemorrhage within 6 months
* Type I Diabetes Mellitus, Type II Diabetes Mellitus with poor glucose control as defined by fasting glucosylated hemoglobin(HbA1c) \> 8%
* nown severe or malignant retinopathy
* hepatic or renal dysfunction as defined by the following laboratory parameters: AST/ALT \> UNL X 2, serum creatinine \> UNL X 1.5
* acute or chronic inflammatory status need to treatment
* need to additional antihypertensive drugs during the study
* need to concomitant medications known to affect blood pressure during the study
* history of angioedema related to ACE inhibitors or Angiotensin II Receptor Blockers
* known hypersensitivity related to either study drug
* history of drug or alcohol dependency within 6 months
* any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of investigational products(ex. gastrointestinal tract surgery such as gastrectomy, gastroenterostomy or bypass, active inflammatory bowel syndrome within 12 months prior to screening, gastric ulcers need to treatment, gastrointestinal/rectal bleeding, impaired pancreatic function such as pancreatitis, obstructions of the urinary tract or difficulty in voiding
* administration of other study drugs within 30 days prior to randomization
* premenopausal women(last menstruation \< 1year) not using adequate contraception, pregnant or breast-feeding
* history of malignancy including leukemia and lymphoma within the past 5 years
* in investigator's judgment