cyrilzakka/clinical-trials huggingface dataset:
Internal Limiting Membrane Peeling on Retinal Displacement

The purpose of this study is to investigate displacement of the retina after idiopathic macular hole surgery with different internal limiting membrane peeling patterns.

After being informed about the study and potential risks, all patients giving written informed consent will undergo a 1-week screening period to determine eligibility for study entry. All patients with idiopathic MH will be randomly allocated into two groups, N-T group or T-N group.

Eligibility Criteria:
Inclusion Criteria:

Eyes with idiopathic macular hole

Exclusion Criteria:

Eyes having re-do macular hole surgery, with high myopia, with proliferative vitreoretinopathy or with a retinal detachment combined with the MH, with other macular diseases, such as age-related macular degeneration.
Helicobacter Pylori Sample Collection Protocol Pre Therapy Subjects

The primary objective is to obtain stool samples from pre-therapy subjects already undergoing evaluation for an H. pylori infection by upper esophagogastroduodenoscopy (EGD) and gastric biopsy.

Stools will be collected and tested, at a later date, in a clinical performance study with an investigational H. pylori antigen assay. This study will be coordinated by the Sponsor.

Eligibility Criteria:
Inclusion Criteria:

* Adult ≥ 22 years, either gender
* Subject is symptomatic showing signs and symptoms of gastritis
* Subject is not under evaluation for post-therapy follow up diagnosis
* Subject is already undergoing upper EGD and obtaining a gastric biopsy as part of routine care for H. pylori diagnosing
* Biopsy is obtained from antrum and/or corpus and is tested by CRM
* At least two of the three CRM tests are performed
* Subject whose EGD with biopsy procedure occurred ≤ 7 days prior to stool collection
* Willing and able to sign the IRB approved Informed Consent form for this project, or able to provide Informed Consent in accordance with 21 CFR 50 Subpart B

Exclusion Criteria:

* Any subject that does not meet the inclusion criteria
* Subject with current severe H. pylori infection
* Subject ingested compounds that may interfere with detection of H. pylori e.g. 4 weeks for all antibiotics, 2 weeks for Bismuth preparations or proton pump inhibitors prior to EGD/collection
* Subject recently tested, less than 3 months and knowledge of H. pylori absence
* Subject tested, less than one year and knowledge of H. pylori presence but NOT undergone prescribed treatment
* Pregnant or lactating
* Inability or unwilling to perform required study procedures
* Subject is unable or unwilling to provide informed consent
Fitting Evaluation of Hydrogel and Silicone Hydrogel Spherical Contact Lenses

This study aims to compare the short-term clinical performance of the three contact lenses (Methafilcon A IV, Ocufilcon B 1-day and Omafilcon A 1-day daily disposable).

This will be a randomized, double-masked, crossover, bilateral non-dispensing study, controlled by cross-comparison. Forty subjects will wear each lens brand for approximately one hour, on three separate study days in random order. Lenses will only be worn during study visits.

Eligibility Criteria:
Inclusion Criteria:

* They are of aged 18-40 and have capacity to volunteer.
* They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent.
* They are willing and able to follow the protocol.
* They agree not to participate in other clinical research for the duration of this study.
* They have a contact lens spherical prescription between -1.00 to - 6.00D (inclusive)
* They have a spectacle cylindrical correction of -0.75D or less in each eye (based on the ocular refraction).
* They can attain at least 0.10 logMAR distance high contrast visual acuity in each eye with the study lenses within the available power range.
* They currently use soft contact lenses or have done so in the previous six months.

Exclusion Criteria:

* They have an ocular disorder which would normally contra-indicate contact lens wear.
* They have a systemic disorder which would normally contra-indicate contact lens wear.
* They are using any topical medication such as eye drops or ointment.
* They have had cataract surgery.
* They have had corneal refractive surgery.
* They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
* They are pregnant or lactating.
* They have any ocular abnormality which would, in the opinion of the investigator, normally contraindicate contact lens wear.
* They have any infectious disease which would, in the opinion of the investigator, contraindicate contact lens wear or pose a risk to study personnel; or they have any immunosuppressive disease (e.g. HIV), or a history of anaphylaxis or severe allergic reaction.
* They have taken part in any other contact lens or care solution clinical trial or research, within two weeks prior to starting this study.
The Effect of a Therapy Dog Activity on Employees' Stress, Mood, and Job Satisfaction and Commitment

The goal of the current study is to determine if participating in a therapy dog activity is associated with changes in perceived stress, mood, and job satisfaction and commitment. A secondary goal is to explore a potential dose effect of multiple treatments as well as control for novelty effect.

This study will be conducted at Aetna Headquarters in Hartford, Connecticut. A pre-post repeated measures design will be used to compare study participant outcomes between a treatment (therapy dog activity) and comparison (low impact physical activity) condition. Outcome variables of interest are perceived stress measured by a stress visual analog scale (SVAS), mood measured by the Positive and Negative Affect Scale (PANAS), and job satisfaction and commitment measured by an investigator-developed Job Satisfaction Survey (consisting of a combination of existing validated scales). Pet ownership, attitudes toward dogs measured by the Dog Attitude Scale, and trait stress, measured by the Perceived Stress Scale, will be assessed as moderating variables.

Eligibility Criteria:
Inclusion Criteria:

* Current Aetna employees

Exclusion Criteria:

* Individuals not employed by Aetna. Note:employees are self-selecting to participate, therefore dog fears or allergies are not listed as exclusion criteria.
Erlotinib Pharmacokinetics During Doxycycline Treatment for Erlotinib-induced Rash

A side effect occurring in a majority of patients taking erlotinib (Tarceva®) consists of a skin rash. Sometimes, symptoms associated with the rash necessitate erlotinib dose reduction or discontinuation. Some physicians have successfully treated the erlotinib-induced rash with doxycycline. At the same time, it has been observed that in patients who develop the erlotinib rash, the cancers respond better to erlotinib treatment. This research study is designed to determine how well doxycycline treats the erlotinib rash and whether doxycycline affects the blood levels of erlotinib.


Eligibility Criteria:
Inclusion Criteria:

* Males and females 18 years of age or older.
* Subjects must have started Tarceva® therapy within three (3) days of trial enrollment.
* Patients must have signed informed consent prior to registration on study.
* Currently receiving erlotinib therapy at 150 mg per day for locally advanced or metastatic NSCLC.
* Patients - both males and females - with reproductive potential (ie, menopausal for less than 1 year and not surgically sterilized) must utilize barrier methods in combination with spermicidal agents for contraception when engaging in sexual intercourse. Women of childbearing potential must provide a negative pregnancy test (serum or urine) within 14 days prior to registration.

Exclusion Criteria:

* Allergy to tetracyclines.
* Use of concurrent agents for papulopustular rash.
* Currently receiving anticancer agents other than erlotinib.
* Inability to interrupt other antibiotic therapy.
* Current use of topical steroids
* Current use of systemic immunosuppressants (e.g., methotrexate, cyclosporine, azathioprine, mycophenolate mofetil)
* Photosensitivity or lupus erythematosus.
* Active gastroesophageal reflux disease.
* Women who have a positive pregnancy test or are lactating by history.
* ECOG performance status ≤3.
* Self report of current smoking or history of smoking within 60 days of screening, or positive urine cotinine test.
* Current use of agents that are known to be strong inducers or inhibitors of CYTP3A4:

  * inhibitors: atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfi navir, ritonavir, saquinavir, telithromycin, troleandomycin (TAO), voriconazole, grapefruit or grapefruit juice
  * inducers: rifampicin, rifabutin, rifapentine, phenytoin, carbamazepine, phenobarbital, and St. John's Wort
* Impaired hepatic function (≤ 30 days before randomization):

  * Alkaline phosphatase \> 3x ULN
  * Aspartate aminotransferase (AST) \> x ULN
  * Alanine aminotransferase (ALT) \> 3 x ULN
  * Total Bilirubin \> 1.5 x ULN
The Effects of Lavender Aromatherapy on Reducing Stress and Anxiety During MRI Procedures.

Research Question:

What effect if any does the use of lavender aromatherapy have on a patient's stress and anxiety during the MRI procedure in the Cardiovascular Services Department?

Hypothesis:

1. The use of lavender aromatherapy will reduce anxiety by 20% during MRI procedures.
2. MRI cancellations related to stress and anxiety will decrease by 10%.

Sample size of 30 patients is needed for the control group and the lavender aromatherapy group, for a total of 60 patients.

Rationale:

Patients undergoing MRI procedures may experience stress and anxiety related to the small and confining space required during the scan. Anyone with a history of claustrophobia, panic attacks, or fear of enclosed spaces is more likely to experience symptoms of panic, fear, or anxiety during the MRI procedure (Harris, Cumming, \& Menzies, 2004, p. 1). This stress and anxiety may cause the patient to abort the scan, the patient may refuse future scans, or the patient's nervous tremors or involuntary quivering may adversely affect the images obtained. Lavender aromatherapy has been shown to reduce stress and anxiety for patients in other settings; however, its use during MRI procedures has not been studied.

This project investigates the use of lavender aromatherapy as a non-pharmacological way to help patients relax during their MRI procedure. Lavender aromatherapy has been studied and shown to reduce stress and anxiety for patients in other situations, but it has not been studied during MRI procedures. Lavender is known to be uplifting, as well as soothing and helpful for reducing stress, anxiety, depression, and insomnia (Herz, 2007, p. 264). If aromatherapy proves useful as an agent to reduce stress and anxiety, patient satisfaction with their MRI procedure will increase and the need for sedating medication could decrease.


Eligibility Criteria:
Inclusion Criteria:

* English speaking
* Able to voluntarily provide consent
* Undergoing elective MRI procedure

Exclusion Criteria:

* Lavender sensitivity or allergy
Colchicine in Atrial Fibrillation to Prevent Stroke

The purpose of this study is to determine the feasibility of performing a randomized controlled trial to investigate the efficacy of an anti-inflammatory drug, colchicine, at reducing well validated markers of thrombosis (D-dimer) and inflammation (hs-CRP).

Atrial fibrillation (AF), the most common cardiac arrhythmia (with a global burden of 33.5 million affected patients in 2010), is responsible for about 20% of ischemic stroke, a major cause of morbidity and mortality. Anticoagulants are very effective in reducing the risk of stroke in AF but on average 10-15% of treated patients still experience a stroke over a 10-year period and in selected elderly populations the risk is even higher. We hypothesize that thrombosis mediated by inflammation might be responsible for the residual risk of stroke, despite anticoagulant therapy and that targeting inflammation has the potential to reduce thrombosis and the risk of stroke in anticoagulated patients with AF.

Eligibility Criteria:
Inclusion Criteria:

* Patients with atrial fibrillation who has been receiving chronic anticoagulation for at least 3 months.

Exclusion Criteria:

* Contraindications to colchicine such as allergy/hypersensitivity,
* Receiving colchicine or other anti-inflammatory drugs (such as corticosteroids, methotrexate, anti-neoplastic, Interleukin 1-1b antagonist, Tumor necrosis factor-alpha inhibitor),
* Receiving food or co-medications such as strong-moderate cytochrome P450 3A4 inhibitors that will result in elevated plasma level of colchicine,
* Inflammatory disorders (SLE, Rheumatoid arthritis, connective tissue disorder) or chronic infection,
* Severe renal (eGFR\< 30ml/min/1.73m2), or liver failure or liver aminotransferase (ALT/AST \> 2x Upper limit of normal),
* Moderate or severe cytopenias (platelet \< 100, neutrophil count \< 1.5) or existing blood dyscrasia (e.g., myelodysplasia)
* Pregnant or lactating woman or woman of child bearing age no protected by reliable contraception.
Serum Soluble ST2 and Plaque Vulnerability in Patients With Acute Coronary Syndrome

This study aimed to assess the association between serum sST2 level and plaque vulnerability in ACS patients. It is hypothesized that serum sST2 level may be related to plaque components and closely associated with plaque vulnerability.

Serum soluble suppression of tumorigenicity-2 (sST2) has emerged as a novel biomarker of atherosclerotic disease. This study aimed to investigate whether elevated serum sST2 level is related to coronary plaque components detected on coronary computed tomography angiography (CCTA) and plaque vulnerability in non-ST elevation acute coronary syndromes (ACS) patients. 167 lesions in 120 non-ST elevation ACS patients were prospectively enrolled and evaluated by CCTA in this study. Blood were taken from antecubital vein during patient's hospitalization for angiography. Serum sST2 level was measured by commerical ELISA kits (Presage ST2 Assay Kit, Critical Diagnostics). CCTA were performed using a 320-slice CT scanner (Aquilion ONE, Toshiba Medical Systems, Otawara, Japan). Coronary plaque components were analyzed cross each of the lesions using commercialized software package (QAngio CT, Medis, The Netherlands).

Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosis of non-ST-elevation ACS

   1. Non-ST-elevation myocardial infarction
   2. Unstable angina
2. Age from 18 to 75 years
3. Underwent CCTA

Exclusion Criteria:

1. Patients needed an immediate (\< 2 h) or early invasive strategy (\< 24 h) according to guidelines:

   1. Haemodynamic instability
   2. Cardiogenic shock
   3. Life-threatening arrhythmias or cardiac arrest
   4. Mechanical complication
   5. Acute heart failure
   6. Dynamic ST or T wave changes
   7. GRACE score \> 140
2. Patients with previous history of:

   1. Coronary artery bypass graft surgery or percutaneous coronary intervention (PCI)
   2. Immune system disorder
   3. Tumor
   4. Acute/chronic infection
   5. Statin use within 3 months
   6. Atrial fibrillation
   7. End-stage renal failure
   8. Iodine-containing contrast allergy
3. Patients with no significant (≥ 50%) stenosis on major epicardial vessels after CCTA performance
4. Patients refused subsequent angiography after CCTA performance
5. Patients with total obstruction on major epicardial vessel
6. Patients with insufficient image quality for QAngioCT analysis
Study of the Safety and Biologic Activity of XOMA 052 in Subjects With Type 2 Diabetes Mellitus

The study hypothesis is that XOMA 052 is likely to improve glycemic control in subjects with Type 2 Diabetes Mellitus.

The purpose of this study is to determine whether XOMA 052 improves glycemic control in subjects on Metformin monotherapy whose diabetes is still not adequately controlled.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with T2D (disease duration \>= 6 months)
* HbA1c measurements \>= 7.0% and \<= 10.0%
* On a stable regimen of metformin monotherapy
* Age \>= 18 and \<= 75
* Stable diet and exercise regimen
* BMI \<= 40 kg/m2

Exclusion Criteria:

* Significant signs and symptoms of uncontrolled hyperglycemia (i.e., polyuria, polydipsia, or polyphagia)
* Uncontrolled hypertension (systolic \> 170 mmHg and/or diastolic \> 110 mmHg)
* Known to be positive for Hep B surface antigen (HBsAg), Hep C virus (HCV), or HIV
* History of allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
* Advanced stage heart failure (New York Heart Association \[NYHA\] class 3 or 4)
* Pulmonary disease requiring medication other than inhaled corticosteroid s
* History of tuberculosis or positive PPD test.
* Active leg, foot, or decubitus ulcer
* Any significant inflammatory, rheumatologic, or systemic autoimmune disease
* History or any symptoms of a demyelinating disease
* History of severe non-proliferative or proliferative retinopathy

Other protocol-defined inclusion/exclusion criteria may apply
A Study to Test if TEV-56286 is Effective in Relieving Multiple System Atrophy (MSA): A Safety and Efficacy Study

The primary objective of the study is to evaluate the efficacy of TEV-56286 administered orally for the treatment of adult participants with Multiple System Atrophy (MSA).

A secondary objective of the study is to evaluate specific efficacy parameters of TEV-56286.

Another secondary objective is to evaluate the safety and tolerability of TEV-56286.

The planned study period per participant is 56 weeks including a screening period (up to 4 weeks), a 48-week double-blind treatment period, and a follow-up visit (approximately 4 weeks after the end of the double-blind treatment period). The study duration will be approximately 27 months.

We plan to open locations in the following countries: US, Israel, Italy, Spain, Germany, France, and Japan

Eligibility Criteria:
Inclusion Criteria:

* is considered to be "clinically possible" or "clinically probable" MSA as determined by the Gilman criteria
* is able to ambulate at least 10 meters without the assistance of another person at screening; the use of assistive device (eg, cane, not walker) is allowed
* is medically and psychiatrically stable, as indicated by medical and psychiatric history, as well as physical and neurological examination
* Females of child bearing potential (CBP) may be included only if they have a negative pregnancy test at the screening and baseline visits
* Females of CBP whose male partners are potentially fertile (ie, no vasectomy) must use highly effective birth control methods
* Males who are potentially fertile/reproductively competent (not surgically \[eg, vasectomy\] or congenitally sterile) and their female partners who are of CBP must use, together with their female partners, highly effective birth control methods

  * Additional criteria apply; please contact the investigator for more information

Exclusion Criteria:

* has 2 or more relatives with history of MSA, suggestive of an alternative diagnosis other than MSA
* has participated in another clinical study involving administration of an IMP within 3 months or 5 half-lives (whichever is longer) of this IMP prior to screening
* has a history of, or acknowledges, alcohol or other substance abuse in the 12 months before screening
* is a female participant who is pregnant or breastfeeding, or plans to become pregnant during the study
* has a known hypersensitivity to any components of the IMP
* is of a vulnerable population (eg, people kept in detention or jail)
* participant is using or consuming any prohibited concomitant medications within the specified exclusionary windows of this study

  * Additional criteria apply; please contact the investigator for more information
Evaluation of Two Different Diet Regimen Prior to Colonoscopy in Children

Colonoscopy is a routinely performed procedure in children and adolescents. Proper visualization of the intestinal mucosa is highly dependent on the quality of the bowel preparation. European Society of Gastrointestinal Endoscopy (ESGE) emphasizes that the timing of bowel preparation is the key factor and recommends that the delay between the last dose of bowel preparation and colonoscopy should be minimized. Timing of bowel preparation prior to colonoscopy has not been studied in children population, yet. The diet regimen before colonoscopy is likely less important than the timing of bowel preparation, however may influence the well-being of children.


Eligibility Criteria:
Inclusion Criteria:

* Age 6-18 years
* Elective colonoscopy

Exclusion Criteria:

* Chronic renal, liver, or heart failure
* Acute surgical abdominal conditions (e.g., acute obstruction or perforation)
* Acute surgical abdominal conditions (e.g., acute obstruction or perforation)
* Any prior gastrointestinal surgery
Relations Between Atherogenic Index of Plasma-Glucose Metabolism

In this study, the investigators aimed to find out whether there is any association between the atherogenic index of plasma with the glucose metabolism.In this respect, apart from the well-known diabetic risk factors, the investigators purposed to reveal new ones.

Atherogenic index of plasma (AIP) is a relatively new index and a predictor of cardiovascular risk. AIP has been shown to be associated with impaired glucose metabolism. This study aimed to evaluate the relationship between AIP and parameters of glucose metabolism.

Methods: This observational study involved 448 healthy individuals who were at risk for diabetes. They were sent to hospital for diabetes check. According to the 75 g oral glucose tolerance test participants were categorized into the three groups; non-diabetic, prediabetic, and diabetic based on the criteria of the American Diabetes Association (ADA). The association between the diabetes group, AIP and parameters of glucose metabolism was analyzed.

The accuracy of registry data compatible with medical records. Statistical analyses were carried out using the Statistical Package for Social Sciences, Windows version 15.0 (SPSS, Chicago, Illinois, USA). Descriptive statistics for each variable were determined. Normality of the data distribution was assessed with the Kolmogorov-Smirnov test. For continuous variables, non-parametric statistics (Mann-Whitney or Kruskal-Wallis), and parametric statistics (t-test, ANOVA analysis) were used as appropriate. Statistically significant differences between the groups were determined by the chi-square test for categorical variables. Associations between the variables were explored using the Pearson correlation and Spearman's rho (for data that was not normally distributed). Linear regression analysis with backward elimination was also performed to define variables associated with AIP.

Eligibility Criteria:
Inclusion Criteria:

* All the participants were previously healthy, aged between 18 and 80 years, and were at risk for diabetes according to new criteria provided by the American Diabetes Association.

Exclusion Criteria:

* Individuals with a history of chronic medical diseases and those who reported current use of any medication were excluded from the study