cyrilzakka/clinical-trials huggingface dataset:
The PIO II Study: In-office Post-op Placement of a Steroid-eluting Sinus Implant

Randomized, controlled, blinded clinical trial with 40 patients randomized in a 1:1 ratio to either treatment (bilateral in-office placement of a drug-eluting implant in the ethmoid sinuses following ethmoidectomy) or control (post-op standard of care) group and followed for 6 months.

This prospective, randomized, controlled, blinded trial aimed to assess the efficacy of a drug-eluting sinus implant placed following ethmoidectomy in addition to post-op standard of care, including debridement, irrigation, and topical steroids, compared to the same standard of care alone (control). Patients returned for follow-up examination at 2 weeks and again at 1, 3 and 6 months after placement. Follow-up examination consisted of patient-reported outcomes and endoscopic grading by clinical investigators and an independent sinus surgeon based on a centralized, blinded video-endoscopy review.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of chronic rhinosinusitis, defined by the AAO-HNS 2015 guidelines, including presence of bilateral ethmoid disease.
* ESS including bilateral ethmoidectomy with middle meatal antrostomy within 7 days prior to scheduled implant placement. Concurrent septoplasty and surgical treatment of the other paranasal sinuses also permitted.

Exclusion Criteria:

* Known history of intolerance to corticosteroids or an oral steroid-dependent condition.
* Known history of immune deficiency, insulin-dependent diabetes, cataracts, or glaucoma
Deep Learning Enabled Endovascular Stroke Therapy Screening in Community Hospitals

After onset of Acute Ischemic Stroke (AIS), every minute of delay to treatment reduces the likelihood of a good clinical outcome. A key delay occurs in the time between completion of computed tomography (CT) angiography of the head and neck and interpretation in the setting of AIS care.

The purpose of this study is to assess the effect of incorporating Viz.AI software, which via via a machine-learning algorithm performs artificial intelligence-based automated detection of large vessel occlusions (LVO) on CT angiography (CTA) images and alerts the AIS care team (diagnosis and treatment decisions will be based on the clinical evaluation and review of the images by the treating physician, per routine standard of care). The hypothesis is that integration of the software into the AIS care pathway will reduce delays in treatment. A cluster-randomized stepped-wedge trial will be performed across 4 hospitals in the greater Houston area.


Eligibility Criteria:
Inclusion Criteria:

* Male or Female
* 18 years of age or older.
* Patients who present to the emergency department with signs and/or symptoms concerning for acute ischemic stroke.
* Patients who undergo CT angiography imaging
* Patients determined to have a large vessel occlusion acute ischemic stroke. This determination will be made based on official radiology report for the CT angiography imaging.

Exclusion Criteria:

* Patients with incomplete data on the electronic medical record.
Thalidomide for Patients With Mild to Moderate Alzheimer's Disease

This is a 24-week, randomized, double-blind, placebo-controlled study of the effect of thalidomide and placebo on CSF (cerebral spinal fluid) and plasma biomarkers in patients with mild to moderate Alzheimer's disease. This study will evaluate the effects of 24 weeks of treatment with Thalidomide on plasma biomarkers.

A lumbar puncture will be done before treatment (baseline), and at 24 weeks to collect CSF for the quantification of biomarkers. As an exploratory effort, we will test the effects of thalidomide on the same biomarkers in the plasma and will determine if detectable changes mirror changes observed in the CSF.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must have a screening diagnosis of Probable Alzheimer's disease according to National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria.
* Subjects must have a Mini-Mental State Examination (MMSE) score of 12-26
* Subject must live at home.
* Must have a caregiver to participate in this study
Comparison of Intraocular Pressure (IOP)-Lowering Efficacy and Safety of AZORGA® Ophthalmic Suspension and COSOPT® Ophthalmic Solution

The purpose of this study is to evaluate AZORGA® Ophthalmic Suspension compared to COSOPT® Ophthalmic Solution for IOP-lowering efficacy in subjects with open-angle glaucoma or ocular hypertension.

After the screening examination, subjects were enrolled in the study and moved into the observation period. During the observation period, prostaglandin-analog (PGA) monotherapy was applied. After the observation period of 4 weeks or more, the baseline examination was performed. Subjects were then randomized and moved into the treatment period.

Eligibility Criteria:
Inclusion Criteria:

* Understand the nature of the study and sign informed consent.
* Diagnosis of open angle glaucoma or ocular hypertension.
* Currently on PGA monotherapy or PGA + alpha-1/beta blocker or PGA + alpha-2 agonist at screening visit, and allowed to instill only PGA for 4 weeks until the baseline visit.
* Intraocular pressure (IOP) ≥ 15 mmHg (at least one same eye) at the baseline visit.
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

* History of bronchial asthma, bronchospasm, or serious chronic obstruction pulmonary disease.
* Uncontrolled heart failure, sinus bradycardia, A-V block (II, III grade), cardiogenic shock, right heart failure due to pulmonary hypertension or congestive heart failure.
* History of hypersensitivity to any of the excipients of the study medications.
* Severe renal function disorders, diabetic ketoacidosis and metabolic acidosis, uncontrolled diabetes, or hepatic disorders.
* Corneal disorder or history of chronic, recurrent or current severe inflammatory eye disease in either eye.
* History of ocular trauma in either eye within 6 months prior to the screening examination.
* Ocular infection or ocular inflammation in either eye.
* History of or current clinically significant or progressive retinal disease in either eye.
* Intraocular surgery in either eye within 6 months prior to the screening examination.
* Ocular laser surgery in either eye within 3 months prior to the screening examination.
* Any abnormality preventing reliable applanation tonometry of either eye.
* Best-corrected visual acuity (BCVA) worse than 0.2 score (decimal visual acuity) in either eye.
* Severe visual field loss in either eye.
* Use of prohibited medication, as specified in the protocol.
* Pregnant, lactating, or intending to become pregnant during the study period.
* Currently on therapy or have been on therapy with another investigational agent within 30 days prior to the screening examination.
* History of or current evidence of a severe illness or any other condition which would make the subject, in the opinion of the investigator, unsuitable for the study.
* Other protocol-specified exclusion criteria may apply.
Acid-suppressing Drugs Pregnancy Asthma Offspring Study

The purpose of this study is

1. To estimate the association between prenatal exposure to proton pump inhibitors (PPIs) and the risk of asthma during childhood.
2. To estimate the association between prenatal exposure to H2-receptor antagonists (H2RAs) and the risk of asthma during childhood.

A cohort study on the association between acid-suppressing drugs in pregnancy and asthma in the offspring

Eligibility Criteria:
Inclusion Criteria:

- Females aged 18-45 years with at least one pregnancy between 1 January 1995 - 31 December 2010 (see study population description)

Exclusion Criteria:

- Males, females below age 18 and 45 years and above (see study population description)
Exploring Participant Preference for Screening Methods and Experience Into Colorectal Cancer Screening Programme

The goal of this low-risk interventional study is to analyze participants' assessment of colorectal cancer screening program through screening method preference and experience after FOBT analysis in screaned participant population for colorectal cancer; could include any of the following: both sexes, age 50-69 years, asympthomatic volunteers. The main aims to answer are:

* Values of experience of participants into screening programme.
* Values of preferences of participants for screening methods.

Participants will answer two questionnaires and they'll be given their information and clinical data to investigator or health personnel.


Eligibility Criteria:
Inclusion Criteria:

* Participants ages from 50 to 69 years (both included) at the time of informed consent signed.
* Participants invited to participate in population-based screening programme who are eligible to undertake FOBT at the Primary Health Care Center.
* Participants should sign an informed consent. They must understand the nature, significance, implications, and risks of the clinical study before signing the informed consent form.

Exclusion Criteria:

* Participants who have not delivery a stool sample in the Primary Health Care Center before signing the informed consent form.
* Participants with a previous colonoscopy in consequence of a FOBT positive result.
* Participants who are in a dependent personal or non-medical relationship with the Sponsor or the Investigators.
Therapy Targeting Depression and HIV Treatment Adherence (The TRIAD Study)

This study will test a therapy for both helping people adhere to their HIV medication regimens and treating them for depression.

People infected with HIV are more likely to suffer from depression than those not infected, with studies finding anywhere from 20% to 50% of HIV-infected individuals having significant depressive symptoms. Depression, in addition to causing persistent sadness and inability to feel pleasure, is related to a lack of HIV treatment adherence. Treatment adherence (making sure to take every pill as prescribed by doctors) is critically important to successful treatment of HIV, because missing even a few doses gives the HIV virus an opportunity to develop immunity to the medication. Poor adherence is related to worse medical outcomes, but even a small, 10% improvement rate in adherence may improve these outcomes. This study will test the efficacy of cognitive behavioral therapy (CBT) that addresses both depression and treatment adherence for HIV-infected people.

Participation in this study will last 1 year, including follow-up visits. All participants will complete an initial one-visit intervention addressing treatment adherence. Then after 2 weeks, participants will be randomly assigned to one of three conditions: CBT for HIV medication adherence and depression (CBT-AD), information and supportive psychotherapy for HIV medication adherence and depression (ISP-AD), or enhanced treatment as usual (ETAU). Participants receiving CBT-AD and ISP-AD will complete 12 therapy sessions over 4 months and will be asked to report any changes to their psychological or HIV treatments. CBT-AD will involve learning to identify and change problematic patterns of thought and behavior, while ISP-AD will involve education and supportive psychotherapy. Participants receiving ETAU will receive only the initial session on HIV medication adherence and will be asked about their psychological and HIV treatment every other week for 4 months.

Major study assessments will take place at baseline and after 4, 8, and 12 months. Assessments will include completing diagnostic interviews and questionnaires, measuring medication adherence through an electronic pill cap, and determining CD4 cell count and viral load (indicators of HIV treatment effectiveness).

Eligibility Criteria:
Inclusion Criteria:

* HIV-infected
* Current diagnosis of depression or prescribed an antidepressant medication with at least some residual symptoms (e.g., clinical global impressions \[CGI\] scale score of 2 or greater)
* Prescribed a stable regimen of highly active antiretroviral therapy (HAART) for HIV for at least 2 months

Exclusion Criteria:

* Active, untreated, and unstable major mental illness (i.e., untreated psychosis or mania) that would interfere with cognitive behavioral therapy (CBT) treatment for depression
* Diagnosis with any primary psychotic disorder, even if treated
* Treatment with CBT within the past year
Effect of Plant Stanol Ester-Containing Spread on Estimated Cardiovascular Risk in Comparison to Mediterranean Diet

Since it is very difficult to have the real thing (Mediterranean diet) we need to find an alternative to reduce cardiovascular disease (CVD) risk in subjects with moderate hypercholesterolaemia (a major CVD risk factor) living in western countries. Therefore, this proposed study is designed to assess if giving olive oil supplements, with or without stanol ester, is equivalent to following a Mediterranean diet. Furthermore, the stanol-olive oil combination may prove to be superior to olive oil alone.

Design: Randomised, double blind, placebo controlled study Number of participants: 150 (3 groups with 50 subjects each). Intervention: One group will be assigned to stanol ester spread (2 g/day) based on olive oil, another on spread with olive oil containing placebo stanol ester (in identical containers with the stanol ester spread). In the third group, a structured effort will be made to improve adherence to Mediterranean diet by at least 2 points in a 10-level scale. Adherence to the Mediterranean diet will be improved by a dietician with detailed explanation of the composition of the diet, preparation of several week specific programs according to dietary preferences of the specific subject. Dietician interviews with a 5 day questionnaire on consumed foods will establish the degree of adherence to Mediterranean diet.

Duration: 16 weeks (4 weeks of lifestyle advice and 12 weeks of treatment).

Prespecified analyses:

1. Postmenopausal women vs women with child bearing potential.
2. Older (\>65 years of age) vs younger subjects,
3. Subjects with impaired fasting glucose levels.

Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects over 45 years of age with mild hypercholesterolaemia (TC levels: 200 mg/dl - 230 mg/dl)

Exclusion Criteria:

Subjects with

* Established CVD (coronary heart disease, peripheral arterial disease, aortic aneurysm, or symptomatic carotid artery disease) or T2DM
* Chronic diseases (including liver diseases)
* Pregnancy
* Malignancies
* Unwillingness to participate
Evaluation of the New Acceleromyograph TOF 3D

The TOF 3D is a new acceleromyograph designed to assess the degree of a neuromuscular block during anesthesia. The study compares the new three-dimensional technique with the established TOF Watch SX.

The TOF 3D is a new acceleromyograph designed to assess the degree of a neuromuscular block during anesthesia. The study compares the new three-dimensional technique with the established TOF Watch SX. The time course of a neuromuscular block (onset, maximal block, time to recovery) is assessed simultaneously with both devices in 50 patients undergoing elective gynecologic surgery requiring neuromuscular block. The validity and reliability of the new technique is evaluated with a Bland-Altman- analysis.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing elective gynecologic surgery requiring general anesthesia and neuromuscular block

Exclusion Criteria:

* anticipated difficult airway
* Risk of pulmonary aspiration
* acute infection
* pregnancy
* renal or hepatic insufficiency
* neuromuscular disease
* chronic intake of drugs influencing neuromuscular block
The Effect of Radioactive Iodine Administration for Thyroid Diseases on H.Pylori Eradication

Because of the high iodine uptake in the stomach, radioactive iodine treatment for thyroid diseases (cancer or hyperthyroidism) or radioactive iodine administered for thyroid scan may be able to eradicate H.pylori infection from the stomach of patients infected with H.pylori.

Also to test the hypothesis that CagA virulent strains of H.pylori are more common in patients with thyroid cancer than with other thyroid diseases.

Objective To test eradicate H.pylori after administration of radioactive iodine (131I) to patients with thyroid diseases and to evaluate their H.pylori CagA status .

Design Observational study

Setting

The Isotopic Institute at the Rabin Medical Center, Campus Beilinson Patients Consecutive patients with thyroid diseases referred to the Isotopic Institute at the Rabin Medical Center, Campus Beilinson for either radioactive iodine (131I) thyroid scan or radioactive iodine (131I)treatment for their disease, will be screened, prior to the radioactive iodine, for H. pylori infection and CagA protein by serology. Patient with positive serology for H. pylori will be tested for active gastric infection using the H.pylori stool antigen test. The study population will include all patients who tested positive for H.pylori both by serology and stool antigen tests. Six to eight weeks and 6 month after administration of radioactive iodine (131I) treatment , stool antigen or H.pylori will be tested again to confirm persistence of H.pylori eradication.

Main Outcome Measure confirmed H.pylori eradication by the stool antigen test. The rate of infection with virulent and caricogenic CagA H.pylori ,will be tested using the immunoblot assay.

Summary

We will test in this study whether Helicobacter pylori is eradicated, after radioactive iodine (131I) administration, from the stomach of patients with thyroid diseases. The rate of CagA virulent and carcinogenic H.pylori infection in theses patients will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients between the ages of 18 and 80.
* Patients with diagnosed thyroid disease referred for thyroid scan or treatment with radioactive iodine (131I).
* Patients who provide informed consent

Exclusion Criteria:

* Patients without diagnosed thyroid disease.
* Patients who are pregnant or breast feeding.
* Patients who have received previous treatment for H. pylori infection.
* Patients taking proton pump inhibitors.
* Patients with recent or current use of antibiotics.
* Patients allergic to iodine (131I).
Ketogenic Diet Health and Longevity

The goal of this pilot intervention is to learn about how a well-formulated ketogenic diet (WFKD) impacts various health factors in generally healthy adults. The main questions it aims to answer are:

* Establish whether an 8-week isocaloric, WFKD improves body composition and metabolic biomarkers in adults without chronic disease.
* Examine changes in transcriptomic sequencing pathways pre- and post-WFKD intervention.
* Explore gut microbial changes in adults without chronic disease that consume a WFKD.

Participants will follow a well-formulated ketogenic diet for 8-weeks. Study procedures include:

* Weekly body weight tracking
* Daily urinary ketone assessment
* Pre/post stool samples for gut microbiota analyses
* Pre/post DXA scans
* Diet quality tracking through 3-day food records


Eligibility Criteria:
Inclusion Criteria:

* 30 to 55 years
* Speaks English as primary language
* BMI 20.0-34.9 kg/m\^2

Exclusion Criteria:

* Certain medications (statin, blood pressure, thyroid hormone replacement, etc.)
* Prior medical diagnosis of type 1 or type 2 diabetes mellitus, cancer requiring chemotherapy or radiation therapy within 5 years, cardiac event, GI disorders, traumatic brain injury/multiple concussions, hypertension, dyslipidemia, or any diagnosis deemed ineligible by study team
* History of renal stones
* Currently lactating
* Already following a ketogenic diet
* Adherence to a specialized diet regimen that disallows compliance
* Use of tobacco or tobacco replacement products within 1 year
Chemotherapy for Patients With Non-Small Cell Lung Cancer

The purpose of this study is to assess the efficacy and toxicity of pemetrexed dosing that is tailored to individual patient tolerance in patients with advanced non-small cell lung cancer (NSCLC).


Eligibility Criteria:
Inclusion Criteria:

* Histologic or cytologic diagnosis non-small cell lung cancer (NSCLC) (Stage IIIB or IV)
* Patients' NSCLC must have progressed following one chemotherapy regimen for palliative therapy with or without subsequent targeted biological therapy
* Disease status must be that of measureable disease as defined by Response Evaluation Criteria In Solid Tumors (RECIST) criteria
* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1

Exclusion Criteria:

* Concurrent administration of any other tumor therapy
* Pregnancy or breast feeding
* Serious concomitant disorders
* Inability or unwillingness to take folic acid or vitamin B12 supplementation
The Metabolomics of Anaphylaxis

Metabolomics is the study of metabolic pathways and the unique biochemical molecules which result from the regulatory response to physiological stressors, disease processes, or drug therapy. By measuring changes in metabolite concentrations, the range of biochemical effects and therapeutic intervention can be determined.

Aspirin exacerbated respiratory disease (AERD) is a chronic inflammatory disease characterized by chronic rhinosinusitis, nasal polyposis, asthma, and airway reactivity to aspirin and/or other nonsteroidal anti-inflammatory drugs (NSAIDs). This reaction to aspirin during challenge/desensitization is equivalent to an allergic drug reaction however we are able to evaluate these specific reactions in a controlled, clinical environment. This population of patients undergoing aspirin desensitization is ideal for studying metabolomics as serial blood sampling can be performed in patients before, during a reaction, and after aspirin desensitization, thereby allowing each patient to serve as his or her own biological control. The investigator hopes that this study of metabolomics will allow for better methods of identifying anaphylaxis in the future.


Eligibility Criteria:
Inclusion Criteria:

* Patients ages 18-75 with a history of aspirin anaphylaxis or a history of hypersensitivity reaction to aspirin and referred for a clinically indicated outpatient or inpatient aspirin desensitization procedure for AERD.

Exclusion Criteria:

* Pregnancy/breastfeeding, possibility of poor compliance, unwilling to undergo aspirin desensitization.