cyrilzakka/clinical-trials huggingface dataset:
End-of-life Intervention for African American Dementia Caregivers

In a community-based approach, the investigators long-term goal is to empower African American family caregivers who are designated healthcare proxies to make informed end-of-life treatment decisions for participants with moderate to severe dementia before a life-threatening medical crisis occurs.

The investigators conducted a randomized controlled trial for efficacy of the Advance Care Treatment Program in an African American church-based community model. The investigators compared the effect of the experimental and control groups on knowledge, self-efficacy, intentions and behaviors from 4 urban African American churches randomly assigned to experimental (n=2) or control (n=2) conditions,304 (experimental n=152; control (n=152) health care proxies of participants that have advanced stage dementia: (a) were concurrently recruited in small classes each with 8-9 healthcare proxies.

Eligibility Criteria:
"Inclusion Criteria"

* Caregiver spouse or adult child of care recipient
* Caregiver knowledgeable about care recipient's medical history
* Care recipient must be African American
* Care recipient must have moderate to severe stage dementia
* Care recipient must lack decisional capacity

"Exclusion Criteria"

* Not a caregiver
* Care recipient not African American,
* Care recipient without moderate to severe dementia
5-year Follow up Study on the Comparative Performance of Two-piece Zirconia and Titanium Implants

A post-market, randomized-controlled, superiority clinical study to compare medium-term performance and safety of the Straumann PURE 2-piece Ceramic Implant with Straumann Bone Level Implant using a fully digital workflow.

Dental implants are a key modality for tooth replacement. Titanium dental implants have been the mainstay of dental implants as it osseointegrate well. Titanium has a silver gray metallic color and therefore, to hide its presence and enhance the aesthetic appearance, the implant is usually placed deeper into the bone tissue and the gums. This has negative consequences since it becomes more difficult to keep the interface between the dental implant and the crown free from bacterial plaque and inflammation. The use of zirconia（a base form of metal with similar properties of titanium in terms of osseointegration) has attracted a lot of interest because of its color that is similar to the one of natural teeth.This study will hence compare the long term performance of standard 4th generation dental implants made of titanium with a second generation zirconia dental implant. The study will evaluate the occurence of biological and technical complications; patient satisfaction and with the aesthetics of the tooth replacement over time.

Eligibility Criteria:
Inclusion Criteria:

following criteria must be met for inclusion in the study:

* Patients must have voluntarily signed the Informed Consent Form before any study related procedures are performed, are willing and able to attend scheduled follow-up visits and agree that the pseudonymized data will be collected, analyzed, and published.
* Patients must be males or females who are a minimum of 18 years of age.
* Patients, who have received a single tooth replacement with a study implant as per-protocol in the premolar-to-premolar area (excluding lower incisors) in the mandible and maxilla and restored with a screw retained ceramic crown.

Exclusion Criteria:

* Patients with conditions or circumstances, in the opinion of the Investigator, which would prevent completion of study participation or interfere with analysis of study results, such as history of non-compliance or unreliability.
* Pregnancy or intention to become pregnant at any point during the study duration.
Improving Medication Safety and CVD Risk Factor Control in Kidney Transplant Recipients

There is a lack of data analyzing the influence of Cardio-vascular Diseases (CVD) risk factor control on graft survival disparities in Black transplant recipients. Studies in the general population indicate that CVD risk factor control is poor in Black patients, leading to higher rates of renal failure and CV events. However, with the exception of hypertension, there is paucity in data demonstrating similar results within transplant recipients. Recent analyses conducted within our transplant program, indicate that CVD risk factors, especially diabetes, are poorly controlled in Black recipients, which likely impacts graft loss. Since these data were collected in a retrospective manner, larger analyses are needed to validate these exploratory findings.

This pilot study is to:

1. Determine if the study is feasible, as measured by the proportions of enrolled to approached and completed to enrolled.
2. Measure and compare, at baseline versus the end of the intervention, the medication safety events, including the number of medication errors, medication non-adherence and medication side effects, in patients enrolled in the study
3. Measure and compare, at baseline versus the end of the intervention, CVD risk factor control, including hypertension, diabetes and dyslipidemia, in patients enrolled in the study
4. Measure and compare, at baseline versus the end of the intervention, patient reported survey results, in patients enrolled in the study
5. Determine if the impact of the intervention is more pronounced in Black recipients, as compared to non-Black recipients


Eligibility Criteria:
Inclusion Criteria:

1. At least 18 years of age and able to give informed consent.
2. Received a first or repeat cadaveric or living donor renal transplant.
3. Patient has adequate graft function, defined as an estimated glomerular filtration rate (GFR) of at least 20 mL/min, using the 4-variable Modification of Diet in Renal Disease (MDRD) equation.
4. Patient is at least one year post transplant.
5. Patient has documented hypertension, defined as a sitting blood pressure of at least 140/90 mmHg or receiving any anti-hypertensive therapy.
6. Patient has documented diabetes mellitus, defined as a hemoglobin A1c of at least 6.5% or receiving any anti-glycemic medications.
7. Willing to comply with all study visits.

Exclusion Criteria:

1. Biopsy proven acute rejection episode that occurred within the past month.
2. Patients who have received an organ transplant other than a kidney.
Evaluation of the Tympanostomy Tube Delivery System

The purpose of this study is to evaluate the performance and safety of the Tympanostomy Tube Delivery System (TTDS) for chronic otitis media or recurrent acute otitis media.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with either chronic otitis media with effusion or acute otitis media and scheduled to undergo tympanostomy tube insertion

Exclusion Criteria:

* Reaction to anesthesia
* Markedly atrophic, bimeric, severely retracted, atelectatic or perforated tympanic membrane
* Otitis externa
* Active acute otitis media
* Otitis media pathology requiring T-tubes
* Stenosed ear canal
* Anatomy that precludes visualization and access to tympanic membrane
* Anatomy that necessitates tympanostomy tube placement in posterior half of membrane
Investigating the Acute Effects of Flavonoids in Blueberries on Cognitive Function.

This study was a controlled, cross-over, acute flavonoid intervention trial with younger and older adults. Subjects consumed a blueberry beverage during one visit and a control beverage on another. Cognitive function pre drink was assessed, blood and urine samples were taken as well as blood pressure and a measure of vascular reactivity. These outcome measures were taken at 2 and 5 hours post drink.

It was predicted that the flavonoids in the blueberry drink would lead to improved performance on the cognitive tests and vascular reactivity measure compared to following the control drink. It was thought this could be due to increased vaso-dilation and improving blood flow to the brain which was investigated in an extension to the project where a sample of individuals underwent brain imaging in an MRI scanner pre and post a blueberry and a control drink.

The control drink was matched to the blueberry drink for other bioactive compounds which may have affected cognition, specifically sugars and vitamin C. Volunteers were healthy, not on any medication, without high blood pressure, high cholesterol, high BMI, diabetes or other medical conditions. Older adults were aged 61-75 years and younger adults 18-26 years.

Blood and urine samples will be analysed for flavonoid levels and Brain Derived Neurotrophic Factor, a biomarker of memory and learning, flavonoids may lead to increased BDNF production through the ERK-CREB-BDNF pathway.

Flavonoids may also increase nitric oxide production and improve the flexibility of the blood vessels hence the measure of vascular reactivity using the Digital Volume Pulse machine. This can lead to increased vaso-dilation and blood flow to the brain, therefore an fMRI study was carried out the investigate this using arterial spin labeling following acute blueberry supplementation compared to a control drink.

Eligibility Criteria:
Inclusion Criteria:

* No medical conditions
* Not taking any medication or supplements (or willing to stop taking supplements for duration of study)
* Not lactose intolerant
* Willing to give blood and urine samples
* Not partaking in frequent vigorous exercise
* Not suffering from or history of depression

Exclusion Criteria:

* On blood pressure medication, taking Aspirin or other blood thinning medication
* BMI \> 30
* Cholesterol \> 6
* Diabetes or other serious medical condition
* Lactose intolerant
* Any learning difficulty e.g. dyslexia
Pneumoperitoneum and Gynecological Laparoscopic Surgery: An Observational Clinical Study

Laparoscopic surgery is now widely established.Laparoscopic surgery involves insufflation of a gas (usually carbon dioxide) into the peritoneal cavity producing a pneumoperitoneum. The raised intra-abdominal pressure of the pneumoperitoneum, alteration in the patient's position and effects of carbon dioxide absorption cause changes in physiology, especially within the cardiovascular and respiratory systems.

The study will be carried out after approval of the ethical committee of Faculty of Medicine, Assiut University. A full preoperative anesthetic assessment will be carried out. Particular attention to the cardiovascular and respiratory systems is essential because of potential effects of the pneumoperitoneum and patient position.

Eligibility Criteria:
Inclusion Criteria:

1. Age range 18-50
2. ASA 1
3. Elective gynecological laparoscopic surgery

Exclusion Criteria:

1. Severe ischemic or valvular heart disease
2. Increased intracranial pressure (e.g. Hydrocephalus, Cerebral tumor, Head injury)
3. Hepatic or renal impairment
4. Emergency surgery
5. Open surgery
6. Previous abdominal surgery
Thick Cornea with High Back Elevation

To follow up cases of thick cornea with high back elevation by pentacam.

The cornea plays a crucial role in refraction and so help in good visual acuity. with its thickness and back elevation being essential parameters in diagnosing and managing corneal diseases such as keratoconus.

The normal human cornea has a central thickness of approximately 540-550 µm. The periphery is generally thicker, reaching up to 700 µm. Corneal thickness is influenced by genetics, hydration, and intraocular pressure.Thick Cornea (\> 540 µm): Seen in conditions such as corneal edema and Fuchs' dystrophy. Thin Cornea (\< 500 µm): Observed in keratoconus, LASIK-induced thinning, and corneal ectasia.

Back corneal elevation is assessed using corneal topography or tomography, typically referenced to a best-fit sphere (BFS). In normal cases, Back corneal elevation is usually ≤12 µm above the BFS, indicating a structurally healthy cornea without signs of ectasia. Susceptible elevation ranges between 12-20 µm, which may be an early indicator of corneal instability, such as subclinical keratoconus. Therefore, it should be evaluated alongside other parameters, including pachymetry, anterior curvature, and biomechanical properties. Abnormal back corneal elevation is generally considered \>20 µm, particularly if localized or asymmetric, and is strongly associated with corneal ectatic disorders such as keratoconus, pellucid marginal degeneration, or post-LASIK ectasia. This abnormal elevation is often accompanied by other risk factors, including increased posterior corneal curvature, corneal thinning, and significant asymmetry, necessitating further assessment and monitoring.

Many cases of thick cornea are associated with high back elevation and this discourage refractive surgery in such cases so in investigator's study the investigator will follow up these cases to determine if these corneas are considered normal corneas or not.

Eligibility Criteria:
Inclusion Criteria:

Any patient can interact with pentacam. Both Genders: include both males and females. Patients with thick cornea (\>540 µm) with high back elevation.

Exclusion Criteria:

* Patients with any eye disease (significant cataract or unstable glaucoma)
* Uncontrolled external disease such as blepharitis , moderate to severe dry eye and allergy.
* Patient with ocular disease such as uveitis, post herpetic infection and corneal opacity
the Influence of General Anesthesia on Tumor Metastasis and Recurrence

The purpose of this study was to investigate whether general anesthesia will affect the postoperative recurrence and metastasis of malignant tumor.


Eligibility Criteria:
Inclusion Criteria:

* ASA I - III Primary liver cancer tumor is single and diameter is less than 3 centimeter There is no major vascular invasion phenomenon, no lymph nodes or extrahepatic metastases The Child - Pugh belong to type A or type B

Exclusion Criteria:

* Had a history of liver surgery (including radiofrequency ablation) Severe disease of heart, lung, kidney, the immune system INR \> 1.5 or platelet count is less than 45000 cells/mm3 History of opioid addiction Metastatic liver tumors Not sure of primary liver cancer Don't agree to participate in this experiment
Dornase Alpha Versus Hypertonic Saline for Lung Atelectasis in Non-Cystic Fibrosis Patients

Despite the lack of trials proving the efficacy of DNase in non cystic fibrosis patients, it is currently heavily used in this population. In fact, per evidence of barcode scanning via Meditech computer system at OU Medical Center 93% of the DNase prescribed in 2005 was for non Cystic fibrosis patients with an estimated yearly cost of $341,968.15.In vitro studies showed that the effect of Dnase was minimal on sputum viscosity when compared to Hypertonic saline . Furthermore recent studies on hypertonic saline in cystic fibrosis patients showed that it is an inexpensive and safe therapy when preceded by a bronchodilator in patients with cystic fibrosis.

We hereby propose a prospective randomized trial to compare the efficacy of hypertonic saline, DNase, vs. normal saline in the treatment of atelectasis in non cystic fibrosis, mechanically ventilated patient.


Eligibility Criteria:
Inclusion Criteria:

1. Patient on invasive mechanical ventilation
2. New Onset (\<48 hours) lobar or multilobar lung atelectasis based on CXR

Exclusion Criteria:

1. Asthma
2. Severe COPD (FEV1\<30%)
3. Pneumothorax or massive pleural effusion, thought to be causing the atelectasis
4. Lobar atelectasis secondary to compressive tumor.
5. Severe hypoxemia (PaO2/FiO2 \< 75)
6. Hemodynamic Instability
7. Cystic fibrosis patients
8. Allergy to DNase
9. Patients on Acetylcysteine
10. Pregnant women
A Study Comparing Powered Ported Bone Marrow Aspiration Procedures to Manual Standard Bone Marrow Aspiration Procedures Using Healthy Volunteers

This single center, randomized, controlled trial will compare the manual standard bone marrow aspiration device to the powered ported bone marrow aspiration device for use in the iliac crest in healthy adult volunteers. The study will compare the subjects' perceived level of pain, time to sample acquisition, and quality of specimen yield of these devices. To serve as their own control, each subject will receive bilateral bone marrow aspiration procedures using both the manual standard and powered ported devices.

This single center, randomized, controlled trial will compare the manual standard bone marrow aspiration needle to the power ported aspiration needle for use in the posterior iliac crest of healthy volunteers for bone marrow aspiration specimen collection. The study will compare the quality of specimen yield of the devices, subject reported level of pain with needle insertion and aspiration, and time from needle/skin contact to needle insertion and to sample acquisition. Each subject will serve as his/her own control and will receive bilateral bone marrow aspiration procedures using both the manual standard and power ported needles. The order in which the devices are used for each subject's procedures and on which side each device will be used will be randomized.

Eligibility Criteria:
Inclusion Criteria:

* Adults 21 years of age and over
* Able to lay flat in prone position on a table for up to 1 hour
* Self-reported as healthy, as confirmed by the investigator during the medical history review and physical examination
* Female subjects with a negative urine pregnancy test at screening visit

Exclusion Criteria:

* Reported fever within 7 days of the screening visit
* Reported active infection within 7 days of the screening visit
* Fever on day of study procedure
* Signs/symptoms of active infection on day of study procedure
* Imprisoned
* Self identified as pregnant or lactating
* Cognitively impaired
* Patients with one or more conditions precluding bone marrow aspiration
* Excessive tissue and/or absence of adequate anatomical landmarks in target bone
* Allergy to local anesthetics
* Unable to lay flat in prone position
* Prothrombin time and International Normalized Ratio (PT/INR) results outside of normal range on screening lab work and deemed clinically significant by the investigator
Trial of the Rapid Antisuicidal Effects of Intranasal Ketamine in Comorbid Depression and Alcohol Abuse

This project aims to evaluate the potential rapid and sustained antisuicidal and antidepressant effects of a single intranasal dose of ketamine in inpatients during a mood episode in Major Depressive Disorder (MDD) or Bipolar Disorder (BD) with or without comorbid recent abuse of alcohol.

Clinicians have a limited ability to predict imminent suicidal behavior and efficacious treatments are not available to treat suicidal patients. Thus, Rapid-acting treatments for suicidal individuals are truly needed. This project aims to evaluate the potential rapid and sustained antisuicidal and antidepressant effects of a single intranasal dose of ketamine in inpatients during a mood episode (in Major Depressive Disorder, MDD or Bipolar Disorder, BD) with or without comorbid recent abuse of alcohol. These results will elucidate the antisuicidal effects of ketamine using the intranasal route along with the identification of associated mediators or moderators; this approach has the potential for enormous public health impact.

Eligibility Criteria:
Inclusion Criteria:

* Voluntary admission to Harris County Psychiatry Center
* Able to provide written informed consent
* Current suicidal ideation and depressive symptoms and Diagnostic and Statistical Manual of Mental Disorders -IV- Text Revision(DSM-IV-TR) depressive episode (also MADRS greater than or equal to 12) and Young Mania Rating Scale (YMRS) score lower than 8
* DSM-IV-TR criteria for current alcohol abuse (but not intoxicated/withdrawal, abstinent from drinking for \> 5 days prior to admission).
* Lifetime history of suicide attempt (patient)
* Not taking any medication in the last 24hs.
* Scale for Suicide Ideation (SSI) score over 4 (first five items) and Columbia scale (C-SSRS) score 4 or 5

Exclusion Criteria:

* Unstable medical condition or medical problem with known central nervous system (CNS) effects, e.g. uncontrolled hypertension systolic blood pressure (SBP) ≥170 and/or diastolic blood pressure (DBP) ≥100) or recent history (6 months) of alcohol-withdrawal seizures or significant abnormal laboratory tests (liver function test (LFT) 3 times higher than normal).
* Prior diagnosis of a DSM-IV-TR psychotic spectrum disorder, psychotic symptoms, or personality disorder.
* Currently under the acute effects of an illicit substance.
* Pregnant or nursing women.
* Subjects with a history of DSM-IV drug dependency or abuse (except for caffeine or nicotine dependence) within the preceding 3 months
Bile and Bile Duct/Pancreatic Duct Brushings Database for Patients With Pancreato-biliary Stricture

The purpose of this study is to create a long-term storage of bile and brushings of pancreato-biliary duct in patients diagnosed with pancreato-biliary stricture for future research.

Recently, a lot of research has been done to test for certain markers in the bile and brushings to detect cancer in a stricture. The samples will be used to measure biomarkers (proteins) in biliary diseases.

Recently, a lot of research has been done to test for certain markers like fluorescence in situ hybridization (FISH), digital image analysis (DIA), and quantifiable morphometric results in biliary stricture brushings. Recently, polysomy FISH has been studied as a promising marker in predicting cancer in a pancreato-biliary stricture. Many genetic, epigenetic, and protein alterations arise during pancreaticobiliary tumor process. The types of markers that have been commonly evaluated as diagnostic assays are mutations, chromosomal gains and losses, and DNA methylation alterations. However there are only a few studies in this area. Testing for these markers can help determine whether the narrowing or stricture in your bile duct is cancer or not.

Eligibility Criteria:
Inclusion Criteria:

* Any patient diagnosed with pancreato-biliary stricture.
* Age \>18 years
* Ability to provide an informed consent

Exclusion Criteria:

* Patients with altered mental status, who will not be able to provide an informed consent
* Pregnant women
A Comparison of Two Color Contact Lenses in Habitual Clear Contact Lens Wearers

The purpose of this study was to evaluate overall satisfaction with AIR OPTIX® COLORS as compared to FRESHLOOK® COLORBLENDS contact lenses.


Eligibility Criteria:
Inclusion Criteria:

* Willing and able to sign Informed Consent Document. If under legal age of consent, legally authorized representative must also sign Informed Consent Document.
* Able to achieve best corrected visual acuity (BCVA) of 20/25 (Snellen) or better in each eye at distance.
* Manifest cylinder less than or equal to 0.75 diopter in each eye.
* Wear contact lenses within protocol-defined specifications.
* Require spherical contact lenses within the available range of powers.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Any eye condition that contraindicates contact lens wear.
* Any systemic or ocular abnormality, infection, or disease likely to affect successful wear of contact lenses or use of their accessory solutions.
* Moderate or severe ocular findings upon examination.
* Any use of systemic or ocular medications that could contraindicate contact lens wear, including use of topical ocular medications requiring instillation during contact lens wear, except for approved lubricating drops.
* Habitual lenses worn in an extended wear modality (routinely sleeping in lenses overnight for 1 night per week or more) over the last 3 months prior to enrollment.
* Previous corneal or refractive surgery or irregular cornea.
* Eye injury or surgery within the last 6 months (excluding placement of punctal plugs).
* Monovision and monocular subjects (only one eye with functional vision) or subjects fit with only one lens.
* History of intolerance or hypersensitivity to any component of the test articles.
* Other protocol-defined exclusion criteria may apply.