cyrilzakka/clinical-trials huggingface dataset:
Trial of Netarsudil for Prevention of Corticosteroid-induced Intraocular Pressure Elevation

Cornea transplant recipients who are using topical corticosteroids long-term to prevent transplant rejection will be randomized to use netarsudil or placebo.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age; male or female patient undergoing Descemet membrane endothelial keratoplasty; patient is able and willing to administer eye drops; patient is able to comprehend and has signed the Informed Consent form; patient is likely to complete the nine-month course of the study.

Exclusion Criteria:

* A patient exhibiting pre-operative intraocular inflammation; a patient with a known sensitivity to any of the ingredients in the study medications; a patient who has a condition (i.e., UNCONTROLLED systemic disease) or is in a situation which in the investigator's opinion may put the patient at significant risk, may confound the study results, or may interfere significantly with the patient's participation in the study; a patient with abnormal eyelid function; a patient that is exhibiting active corneal ulceration, keratitis, or conjunctivitis, or who has a history of herpetic keratitis; a patient who has been diagnosed with uncontrolled glaucoma, prior aqueous shunt or trabeculectomy, or with preoperative intraocular pressure \> 22 mm Hg in the potential study eye; presence of any ocular disease that would interfere with the evaluation of the study treatment (however, patients with a history of cystoid macular edema, age-related macular degeneration, corneal neovascularization, and other non-interfering comorbidities may be enrolled); a patient with a history of non-compliance with using prescribed medication; a patient who is concurrently involved in or participated in another randomized clinical trial within 30 days prior to enrollment in this study; patients who are pregnant or planning to become pregnant within the duration of the study.
Pilot Trial of Zoledronic Acid to Prevent Bone Loss in Hematopoietic Cell Transplant Recipients

Patients who undergo bone marrow transplant for different types of cancer are exposed to many treatments such as steroids and whole body radiation. These treatments make the transplant possible but also make their bones weaker and more prone to fractures which can be a source of significant disability and decreased quality of life for cancer survivors. Our trial will investigate whether giving one dose of Zoledronic acid (a commonly used drug given to preserve bone mass in osteoporosis) before bone marrow transplant can protect from the bone loss caused by the transplant procedures. The investigators are also interested in studying the complex interactions of bone, muscle and fat which are greatly affected after bone marrow transplant.

Primary Objective:

To determine whether a single dose of zoledronic acid pre-transplant will prevent HSCT-related bone loss without impeding engraftment, compared with placebo.

Secondary Objectives:

To identify bone and muscle deficits and alterations in fat distribution prior to HSCT, compared with healthy controls.

Eligibility Criteria:
Inclusion Criteria:

* First allogeneic HSCT
* Age \> 18 years
* Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

* Current or prior use of bone active medication (bisphosphonates, teriparatide, selective estrogen receptor modulators, or Denosumab)
* Hypo- (Ca \< 8.5 mg/dL) or hyper-calcemia (Ca \> 10.5 mg/dL)
* Hyperthyroidism (TSH \< 0.4 mIU/L and free T4 \> 1.6 ng/dL)
* Hyperparathyroidism (PTH \> 80 pg/mL)
* Estimated GFR \< 35 ml/min/1.73 m2
* Other chronic disease unrelated to HSCT that may impact bone metabolism
* Osteoporosis: patients with a history of fragility fracture, or a Hip or Spine T score of \<-2.5 (these patients will be treated with Zoledronic Acid and followed, but excluded from randomization)
Phase 2 Study of BIIB092 in Participants With Early Alzheimer's Disease

The primary objective of the placebo-controlled period is to evaluate the safety and tolerability of BIIB092 in participants with mild cognitive impairment (MCI) due to Alzheimer's disease (AD) or with mild AD. The secondary objectives of the placebo-controlled period are to evaluate the efficacy of multiple doses of BIIB092 in slowing cognitive and functional impairment in participants with MCI due to AD or with mild AD, and to evaluate the immunogenicity of BIIB092 after multiple doses in participants with MCI due to AD or with mild AD.

The primary objective of the long-term extension period is to evaluate the long-term safety and tolerability of BIIB092 in participants with MCI due to AD or with mild AD.


Eligibility Criteria:
Key Inclusion Criteria:

* Must have a gradual and progressive change in memory function over more than 6 months.
* Must meet all of the clinical criteria for mild cognitive impairment (MCI) due to Alzheimer's disease (AD) or mild AD and must have
* Objective evidence of cognitive impairment at Screening
* Clinical Dementia Rating Scale (CDR) global score of 0.5 for MCI due to AD or 0.5 or 1 for mild AD
* Mini-Mental State Examination (MMSE) score of 22 to 30 (inclusive)
* CDR Memory Box score of ≥0.5
* Must consent to apolipoprotein E (ApoE) genotyping
* Must have 1 informant/study partner
* Must have amyloid beta positivity confirmed at Screening

Key Exclusion Criteria:

* Any medical or neurological/neurodegenerative condition (other than AD) that, in the opinion of the Investigator, might be a contributing cause to the participant's cognitive impairment or could lead to discontinuation, lack of compliance, interference with study assessments, or safety concerns
* Clinically significant, unstable psychiatric illness
* Have had a stroke or Transient Ischemic Attack (TIA) or unexplained loss of consciousness in the past 1 year
* Relevant brain hemorrhage, bleeding disorder and cerebrovascular abnormalities
* History of unstable angina, myocardial infarction, chronic heart failure or clinically significant conduction abnormalities within 1 year prior to Screening Visit 1
* Indication of impaired renal or liver function
* Alcohol or substance abuse in past 1 year
* Clinically significant systemic illness or serious infection within 30 days prior to or during the screening period
* Use of allowed medications for chronic conditions at doses that have not been stable for at least 4 weeks prior to Screening Visit 1 and during the screening period up to Study Day 1, or use of AD medications at doses that have not been stable for at least 8 weeks prior to Screening Visit 1 and during the screening period up to Study Day 1.
* Use of any medications that, in the opinion of the Investigator, may contribute to cognitive impairment, put the participants at higher risk for adverse events (AEs), or impair the participant's ability to perform cognitive testing or complete study procedures.
* Contraindications to study procedures

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
Lipid-lowering Effect of Plant Stanol Drink

To determine the effect of investigational products on serum LDL cholesterol.


Eligibility Criteria:
Inclusion Criteria:

* healthy mildly to moderate hypercholesterolemic (serum total cholesterol 5.2-8.5 mmol/l) adults
* signed written informed consent

Exclusion Criteria:

* participation in a clinical study within 30 days prior to screening visit and throughout the study
* severe obesity
* consumption of lipid/cholesterol lowering medication 1 month prior to the screening visit and throughout the study
* consumption of plant stanol or plant sterol containing food products such as Benecol or Becel pro active 1 month prior to visit 2
Study Comparing the P200TE and the P200TxE in Glaucoma Patients

The study evaluates the image quality between two OCT devices.

The objective of this study is to collect OCT scans to compare the qualitative B scan images produced by the P200TxE to the P200TE device in glaucoma subjects.

Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects 22 years of age or older who have full legal capacity to volunteer on the date the informed consent is signed;
* Subjects who can follow the instructions by the clinical staff at the clinical site,
* Subjects who agree to participate in the study;
* Subjects who have been diagnosed with glaucoma in the study eye as confirmed by the investigator;

Exclusion Criteria:

* Subjects unable to tolerate ophthalmic imaging;
* Subjects with ocular media not sufficiently clear to obtain acceptable OCT images;
* Subjects with any clinically significant ocular pathology except glaucoma, as determined by self-report and/or investigator assessment on the day of the study visit;
* Subjects who are not reliably tested with at least one Humphrey Field Analyzer (HFA) visual field (24-2 or 30-2, white on white) measured on the day of the study visit or within the previous year from the study visit, defined as fixation losses \> 20% or false positives \> 33%, or false negatives \> 33%;
* Subjects with history of dementia or multiple sclerosis
Impact of Early Renal Involvement on the Development of Severe In-hospital Renal Failure

The purpose of this study is to determine whether renal team involvement early at the onset of kidney injury will prevent further developement of more severe renal failure and worse hospitalization outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Hospitalized, elevation in creatinine meeting definition

Exclusion Criteria:

* CDK5, ESRD,solid organ transplant
Effects of a Platelet Transfusion Best Practices Alert

This study is to determine the effectiveness of a computerized clinical decision support tool (Best Practice Alert - BPA) in reducing unnecessary platelet transfusions based on guidelines published by national transfusion societies such as the AABB (formerly American Association of Blood Banks).

A computerized alert will be deployed through the electronic health record. The alert will trigger when a provider orders platelet transfusion above a threshold supported by current guidelines. The alert will provide information on current evidence and give the provider the option to cancel the order or proceed. The alert will not be triggered in procedural areas such as the operating room or as part of any emergency orders to prevent any delays to urgent patient care.

The proposed project will evaluate this alert by randomizing its implementation by patient chart. The investigators will observe the prevalence of this alert and its impact on ordering practices for the next 3 months. For patient charts randomized not to receive the intervention, the providers will not receive any alerts, but the analytics tool will record if the alert would have been triggered and the pertinent clinical information. After a period of three months, the investigators will review patient and provider information through analytics tools, assessing differences in platelet usage between the patients whose charts showed the alerts vs. those (control) patient charts not showing alerts.

Eligibility Criteria:
Inclusion Criteria:

* Recent platelet count \>50k/uL
* Platelet transfusion ordered

Exclusion Criteria:

* Neurosurgery
* Procedure area (OR, catheterization lab, interventional radiology suite)
* Documented history of antiplatelet agent
Dreams and Bereavement

The aim of the study is to investigate a possible role of dreaming in emotion regulation testing whether dreaming of a close relative recently deceased is correlated with a positive evolution of the bereavement process


Eligibility Criteria:
Inclusion Criteria:

* age \> or = 18 years old
* the death of a close relative in the last 3 months

Exclusion Criteria:

- history of psychiatric and neurologic disease
Evaluation of Elastic Properties of Ascending Aorta

The aim of our study is to assess a correlation between local patient specific elastic modulus distribution of the ascending aorta from a biaxial tensile test and MRI measurements of the elastic properties of the aorta.

A total of 70 patients referred for ascending aorta (AA) replacement underwent a preoperative cardiac-MRI for the evaluation the elastic properties and ascending aorta tissue was collected for biaxial testing to obtain maximum elastic modulus

Observational and prospective trial on medical data only. The patients are operated of planned aortic aneurysm without additional intervention.

The preoperative cardiac MRI are planned in standard of care.

Eligibility Criteria:
Inclusion Criteria:

* patient referred for ascending aorta aneurysm requiering replacement
* elective patient

Exclusion Criteria:

* claustrophobia
* contraindication to performing cardiac MRI
Tracheal Dosage of Amylase : a New Surrogate for Microaspirations in Ventilated ICU Patients

Microaspirations of the oropharyngeal ± gastric contents through the endotracheal tube cuff contribute to the constitution of VAP. The pepsin has been recently proved effective as a surrogate of gastric content and was assessed in tracheal secretions. However, the pepsin dosage is fastidious, expensive and only characterizes aspirations from gastric origin. The aim of our study is to asses whether the value of amylase, which is mostly secreted by salivary glands, may turn out to be a new and simpler surrogate for microaspirations in ventilated ICU patients. Thirty patients ventilated for an anticipated length \> 48h whose endotracheal tube includes a subglottic secretion device and producing sufficient endotracheal aspirations will be included. From H48, 4 sets of 3 aspirations each (oral, subglottic, tracheal) will be performed during one ventilation day for amylase dosage purpose. In ten of these patients, a comparison between pepsin and amylase will be assessed. In addition, 10 non intubated patients with an indication to bronchoscopy and necessitating a tracheal aspiration during the procedure will be included as a control group. The primary assessment criteria will be the oral/tracheal amylase ratio.


Eligibility Criteria:
Inclusion Criteria:

* intubated and ventlated patients group: patients ventilated with a tube including a subglottic secretion device for an anticipated length \> 48h and producing sufficient endotracheal aspirations
* non intubated patients group: patients with an study-independant indication to bronchoscopy and necessitating a tracheal aspiration during the procedure

Exclusion Criteria:

* patients ventilated for less than 48h
* patients developing ventilated-acquired pneumonia or bronchitis before potential inclusion
* paralysed patients
* patients requiring a closed suction device
* patients with relative contraindications to endotracheal aspiration (status asthmaticus, severe ARDS with PF ratio \< 100, hemorragic risk, brochopleural fistula)
* bronchiectasis, cystic fibrosis
* moribund patient or ethical decision to withhold or withdraw intensive care.
Efficacy Assessment of Chinese Herbal Medicine Tangweian Recipe Treating Participants With Diabetic Gastroenteropathy

This study is a randomized, positive drug parallel-controlled clinical trial in participants with diabetic gastroenteropathy. A total of 60 participants will be recruited for the study, all of whom are diagnosed as diabetes mellitus combined with gastroenteropathy. The subjects will be divided randomly into two groups and treated with either Tangweian Recipe+mosapride citrate tablets or mosapride citrate tablets for four weeks. The primary outcome will be the change in gastroparesis symptom severity, as measured by the American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptoms Daily diary Index-Daily Diary (ANMS GCSI-DD). And participants will be seen for a clinic evaluation at weeks 0 and 4, during which symptom scores, adverse events and treatment compliance will be assessed.


Eligibility Criteria:
Inclusion Criteria:

1. Aged 18 to 70 years at the time of their consent;
2. Those diagnosed with diabetic gastrointestinal lesions with gastrointestinal symptoms such as nausea/vomiting, early satiety, bloating, and epigastric pain for more than 3 months or longer;
3. History of symptoms of mellitus for at least 5 years leading up to the Screening Visit and Blood glucose stable within 1 month;
4. Mean Gastroparesis Cardinal Symptom Index (GCSI) score ≥ 2; or delayed gastric emptying confirmed at screening by gastric emptying breath test (GEBT);
5. TCM Syndrome differentiation as spleen deficiency and stomach stagnation syndrome;
6. Signed informed consent.

Exclusion Criteria:

1. Patients with diabetic ketoacidosis, hyperosmolar nonketotic diabetic coma, severe infection, and surgery in recent one month;
2. Patients with gastrointestinal reactions caused by glucose-lowering drugs and patients treated with GLP-1 class drugs;
3. Have a history of or are suffering from severe gastrointestinal disease
4. Gastrectomy, fundoplication, vagotomy, pyloroplasty, bariatric surgery, or gastric stimulation device surgically implanted within the last year;
5. Combination of severe cardiovascular and cerebrovascular diseases, hepatic and renal insufficiency, psychiatric patients, drug abuse and dependence;
6. Women who are pregnant, preparing for pregnancy or breastfeeding;
7. Patients who participated in other clinical studies within one month prior to participating in this study or were participating in other clinical studies;
8. According to the judgment of the researcher, other diseases or conditions that reduce the possibility of enrollment or complicate the enrollment, such as frequent changes in working environment and unstable living environment, are likely to cause loss of follow-up.
The REALITY Study - a Real-life Long-term Analysis of Xolair Therapy

The primary objective is to assess the clinical effectiveness of long-term omalizumab therapy in 240 patients treated over an 8 year period in a real-life clinical setting and to compare the pre- and post-treatment clinical characteristics to identify and better understand the markers of response to omalizumab.

To date, there are no established criteria for identifying 'response' to omalizumab therapy. Currently, the commonly accepted clinical criterion for omalizumab treatment response is the physician's overall assessment, GETE (Global Evaluation of Treatment Effectiveness). Most clinical trials have evaluated the efficacy of omalizumab treatment after a 16 week treatment period and lack the impact of long-term omalizumab therapy.

Investigators propose multiple approach modules to better assess and identify 'response' and to define 'responders' to omalizumab and evaluate the long-term impact in a real-world clinical practice. Besides evaluating individual outcome variables, it is important to attempt the 'clustering of variables' to further investigate if any baseline clinical phenotypes are predictive of better response enabling us to refine the patient population who will gain most benefit from therapy.

Medical records from 240 omalizumab-treated patients will be evaluated. Comprehensive data will be collected for any asthma-related event (see evaluation criteria below), omalizumab dose, asthma-medications, spirometry, asthma control test (ACT) and any respiratory infection and/or antibiotic use since last visit. Data will be analyzed to compare the clinical phenotypes and outcome among patients to identify, characterize and define 'responders' and 'non-responders' to omalizumab. Periodic assessments for demonstrated level of response and need for continued therapy will be evaluated quarterly. Also, real-life patient adherence data to long-term omalizumab therapy will be analyzed and the factors for withdrawal and non-adherence will be identified.

Reduction in annualized rate of asthma exacerbation, steroid bursts and oral steroid dosage, ER/unscheduled doctor's visits, hospitalization and improvement in spirometry and ACT score and review of asthma medications will be evaluated quarterly. 'Cluster analysis' will be performed by grouping variables (such as age, asthma duration and severity, dosage, therapy duration, sensitization profile, IgE levels etc.) in effort to identify groups of responders.

Eligibility Criteria:
Inclusion Criteria:

1. Moderate-to-severe persistent allergic asthmatic patients with inadequate asthma control
2. Received Omalizumab therapy per steps 5 \& 6 of the NHLBI guidelines
3. Positive skin test or in-vitro specific IgE to perennial allergens
4. Measured baseline total serum IgE level (within 1 year from first dose)
5. Patient followed at AAIAST/AARC (from February 2004 to December 2011)

Exclusion Criteria:

* N/A; retrospective study
A Study to Determine the Effects of MK0557 in Obese Subjects (0557-006)(COMPLETED)

The purpose of this study is to assess the effects of MK0557 on body weight in obese subjects.


Eligibility Criteria:
Inclusion Criteria:

* Men and women between 21 and 65 years of age, willing to avoid all prescription and nonprescription medicine to alter body weight for entire study

Exclusion Criteria:

* You are or plan to become pregnant
* You have smoked or used nicotine within 6 months of the study
* History of abusing alcohol and/or drugs
* History of a stroke, you have diabetes mellitus, you are taking medication for high blood pressure, you have had recent surgery, you have been involved in another study within 3 months of study, use of cholesterol or anti-seizure medication during the study
* Have participated in a weight loss program 3 months before the study or during the course of the study
Lipid Efficacy/Tolerability Study (0524A-020)

A 28-week clinical trial in patients with primary hypercholesterolemia or mixed hyperlipidemia to study the effects of MK0524A on lipids and tolerability. There will be 9 scheduled clinic visits, and 3 treatment groups. A patient can be randomly assigned to 1 of the 3 treatment groups.


Eligibility Criteria:
Inclusion Criteria:

* Patients 18 to 85 years of age with Primary Hypercholesterolemia or Mixed Hyperlipidemia with LDL-C below 100 mg/dL for high risk patients (patients with Coronary Artery Disease (CHD).
* Have medical conditions considered to be CHD equivalent).
* LDL-C below 130 mg/dL for patients with multiple risk factors.
* LDL-C between 130 and 190 mg/dL for patients with low risk and Triglycerides \</= to 350 mg/dL.

Exclusion Criteria:

* A condition which, in the opinion of the investigator, might pose a risk to the patient or interfere with participating in the study, patients \< 20% compliance, patients with chronic medical conditions, patients with unstable doses of medications.
* Pregnant or lactating women, or women intending to become pregnant are excluded.
* Patient with diabetes mellitus that is poorly controlled, newly diagnosed, has recently experienced repeated hypoglycemia or unstable glycemic control, or is taking new or recently adjusted antidiabetic pharmacotherapy (with the exception of +/- 10 units of insulin).
* Patients with the following conditions: chronic heart failure, uncontrolled/unstable cardiac arrhythmias, unstable hypertension, active or chronic hepatobiliary or hepatic disease, HIV positive, gout (within 1 year).