cyrilzakka/clinical-trials huggingface dataset:
Phase I Study to Evaluate the Tolerability of Eye Drop DA-6034 in Healthy Volunteers

This is a double-blind, randomized, placebo-controlled, 4-period, cross-over clinical trial. The study is designed to evaluate the safety and local tolerability of DA-6034 upon single and repeated-dose topical application to the both eyes in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* 20-50 year-old healthy subjects

Exclusion Criteria:

* Presence or history of dry eye or other ocular or systemic diseases
* Corrected visual acuity less than 20/40 in either eye at the screening
* Any eye surgery or laser eye surgery within the past six months
* Intraocular pressure greater than 22 mmHg in either eye at the screening
* Break-up time less than 10 sec with OSDI score corresponding to mild to severe dry eye symptoms in either eye at the screening
* Unanesthetized Schirmer scores \<10 mm in either eye at the screening
Assessment of GBR in Augmentation of Horizontally Atrophic Maxillary Ridge Using Collagen Membrane Versus Using Titanium Mesh

this study is aiming to Assess postoperative complications and bone quality and quantity in augmentation of horizontally atrophic maxillary ridge using a 1:1 mixture of autograft and xenograft particulate bone covered with collagen membrane with the new Sausage technique™ versus using the same mixture covered with titanium mesh.

patients with atrophic maxillary ridge \< 4 mm will be selected in this study for augmentation for future implant placement. The full thickness flap will be elevated including one extra tooth on each side of the edentulous area or if completely edentulous 5 mm on each side.. the bone bed will be prepared by cleaning any debris and Multiple decortication holes will be performed with a 2.0 mm round bur. the harvested bone from the chin is then mixed with the xenograft with ratio 1:1 and then put on the recipient site and will be covered with a collagen membrane with the Sausage technique (intervention group) and the other group the graft will be covered with titanium mesh (control group).

flap is repositioned and sutured. followup for 6 months and then CBCT is done. Reopening after 6 months, core biopsy is taken by a 2 mm thickness trephine from the healed augmented bone at the site of implant placement and will be sent for histomorphometric analysis and the bone thickness (buccolingual ) dimension is measured using a caliper and from the CBCT (cone beam CT) the bone width gain will be calculates and recorded.

postoperative complications( infection, wound dehiscence or membrane exposure) will be monitored and recorded.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with horizontal atrophied maxillary ridge (thin ridge) less than 4mm.
2. All ages and both sexes were included in this study.
3. Patients should be free from any systemic disease that may affect normal healing of bone, and predictable outcome.
4. Patients with physical and psychological tolerance

Exclusion Criteria:

1. Patients with high risk systemic diseases like uncontrolled diabetes mellitus. As uncontrolled diabetes mellitus has a negative impact on normal bone healing. 8
2. Heavy smokers.4
3. Alcohol or drug abuse
4. Gingival bleeding or full mouth plaque index ≥ 25%.4
5. Patients with physical and psychological intolerance. As psychological stress will affect the immune system and patient's fitness including healing capacity. 9
6. Unavailability for regular follow-ups
Impact of Social Risk Decision Support

The purpose of this study is to determine the impact of embedding a risk-stratification tool, designed to identify patient needs for services that address social determinant of health related needs, in a commercial electronic health record system (EHR).

Social determinant of health related needs and social risk factors complicate care delivery and drive health and well-being. Social needs are common among undeserved patient populations, but health care providers are often not equipped to routinely identify and address patients in need.

Using a combination of health information exchange, electronic health record, and aggregate datasets the investigators developed predictive algorithms to identify patients a highest risk for a need for a referral to a social worker, dietitian, behavioral health, or other wraparound service provider. Risk scores are available to primary care providers in two ways within the electronic health record system (EHR): 1) a graphical summary of individual risk or 2) a line listing of all scheduled patients.

The investigators are introducing the risk-stratification tool in an urban safety-net primary care provider on a voluntary usage basis.

Eligibility Criteria:
Inclusion Criteria:

* Encounters among patients seeking primary care service at any of the 9 Eskenazi Health FQHC clinics in Indianapolis, IN from January 2017 to May 2020.
* The propensity score matched primary care encounters from non-Eskenazi facilities.

Exclusion Criteria:

* Emergency encounters or hospitalizations
Single Dose of Etomidate and Adrenal Cortex

we aim to evaluate the effects of single dose of etomidate or use of steroid prior to etomidate during emergency intubation on hemodynamics and adrenal cortex.


Eligibility Criteria:
Inclusion Criteria:

* Patients between 25-65 years old with American Society of Anesthesiology scores III or IV that have applied to emergency department and receives an indication for intubation by the intensive care unit physicians will be included to the study

Exclusion Criteria:

* Patients using steroid prior to the intubation and/or patients with chronical inflammatory diseases will be excluded from the study.
Coventry Outcomes Study of Seniors (COSS): A Comparative Effectiveness Study to Evaluate the Effect of a Multidisciplinary Team's Intervention on the Incidence of Nonelective Hospitalizations in a Medicare Population

The investigators are studying the impact of the interventions of a multidisciplinary team (MDT) - consisting of a Coventry case manager, social worker, and medical director, alongside a Medco specialist pharmacist - on the hospitalization rates of high risk seniors with chronic conditions, compared with a usual care approach. The study will also examine the impact on quality of life, medication adherence, medical costs, hospital readmission rates, and a variety of other important measures. The outcome of COSS may support a means to further enhance and develop a comprehensive care model program by leveraging the partnership between a health plan and a pharmacy benefit manager.

The multidisciplinary team will provide face-to-face visits in a home setting with interventions that focus on five key areas: care transitions, self-management, care coordination, pharmacy and prevention, all designed to support high-risk Medicare members and their relationship with their primary care providers. If the study proves to reduce hospitalizations in the senior population, it could provide important guidance for future efforts to reduce the cost and improve the quality of care for seniors with chronic conditions.

Eligibility Criteria:
Inclusion Criteria:

* Inouye Risk Score \>3 calculated on Coventry Claims
* Medicare Advantage beneficiaries age \> 65 years
* Continuous eligibility \> 12 months prior to study
* Ability to be contacted via telephone
* Subject is willing and able to provide informed consent
* Willing to comply with all study procedures and be available for the duration of the study

Exclusion Criteria:

* Active cancer treatment (i.e. chemotherapy or radiation) in the past 6 months
* Living anywhere other than a community setting \[i.e. Skilled nursing facility (SNF)\]
* Just-In-Time (JIT) Members
* Members with a geographic location \> 60 from either St. Louis or Kansas City, MO.
* Solid organ transplant recipients
* Active enrollment in another clinical research study
Bridging Intestinal Failure With Teduglutide - a Case Report

In this case report the investigators present a novel strategy for using teduglutide as a bridging therapy to intestinal reconstruction.


Eligibility Criteria:
Inclusion Criteria:

short bowel syndrome

Exclusion Criteria:

* \<18 years
Neonatal Erythropoietin in Asphyxiated Term Newborns

The purpose of this study is to determine the safety and pharmacokinetics of moderate to high doses of erythropoietin in newborn infants with birth asphyxia.

Newborn infants with birth asphyxia are at high risk of death or long-term neurologic disability; yet therapies for birth asphyxia are currently limited. Erythropoietin (Epo) is a FDA-approved drug that is an effective neuroprotective agent in animal models of birth asphyxia. This is a phase I dose finding multi-center trial that will test the safety and pharmacokinetics of Epo in human infants with birth asphyxia. The long-term objectives of the proposed research are to reduce mortality and to decrease the risk of long-term disabilities in infants who survive beyond the newborn period.

Eligibility Criteria:
Inclusion Criteria:

1. ≥ 36 weeks gestational age
2. Perinatal depression (low Apgar score, need for resuscitation)
3. Moderate to severe encephalopathy

Exclusion Criteria:

1. Specific aEEG findings
2. Intrauterine growth restriction
3. Severe congenital anomaly, genetic syndrome, metabolic disorder, arthrogryposis, TORCH infection
4. Microcephaly
5. Infant older than 23.5 hours of age at the time of consent
6. Infant judged by an attending physician to be likely to die due to the severity of illness
7. Polycythemia
8. Hypertension
9. No in-dwelling line
Study of MAX-40279 in Patients With Relapsed or Refractory Acute Myelogenous Leukemia (AML)

This is a non-randomized, open-label, single-arm, dose-escalation Phase I study to evaluate the safety and tolerability of MAX-40279-01 in patients with Relapsed or Refractory AML.

This is a two-part study comprised of a dose escalation part and a dose expansion part.

Eligibility Criteria:
Inclusion Criteria:

* Males and/or females over age 18.
* Subject has morphologically documented relapsed or refractoryprimary AML as defined by the World Health Organization (WHO) 2016 criteria for which no established standard therapy is available.
* ECOG performance status of 0 to 2.
* Persistent chronic clinically significant non-hematological toxicities from prior treatment (including chemotherapy, kinase inhibitors, immunotherapy, experimental agents, radiation, HSCT, or surgery) must be Grade ≤ 1.
* Any anti-tumor treatment with radiation therapy, surgery, or immunotherapy wihtin 2 weeks prior to trial entry.
* Life expectancy of at least 3 months.
* Both men and women of reproductive potential must agree to use a highly effective method of birth control during the study and for six months following the last dose of study drug.

Exclusion Criteria:

* Disease diagnosis of acute promyelocytic leukemia.
* Medical history of difficulty swallowing, malabsorption or other chronic gastrointestinal disease, or conditions that may hamper compliance and/or absorption of the tested product.
* Previously treated malignancies other than the current disease, except for adequately treated non-melanoma skin cancer, in situ cancer, or other cancer from which the subject has been disease-free for at least 5 years at the trial entry.
* Laboratory values not within the Protocol-defined range.
* Concomitant disease or condition that could interfere with the conduct of the trial, or that would, in the opinion of the Investigator, pose an unacceptable risk to the subject in this trial.
A Methodology Study Of Brain Imaging Of Pain-Killers In Post-Traumatic Neuropathic Pain Patients

This study is a methodology study designed to discover whether a brain imaging technology is a better way of compare the relative sensitivities of fMRI and subjective psychometric assessments of pain to multiple doses of pregabalin and tramadol SR in a cross-over clinical study design.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of neuropathic pain associated with brush allodynia in specific dermatomes.
* Brush allodynia score of ≥4 and calculated average pain score of ≥3 on an 11-point numerical rating scale by the completion of down-titration of existing medications.
* Right-handed

Exclusion Criteria:

* Subjects with trigeminal neuralgia, central pain (due to cerebrovascular lesions, multiple sclerosis and/or traumatic spinal cord injuries including spinal surgery).
* Phantom limb pain, painful diabetic neuropathy.
* Subjects with any other co-existing pain which he/she or a qualified pain physician cannot differentiate from NeP of peripheral origin.
* Subjects with diabetes mellitus and with an HbA1C value of \>10% upon measurement at screening.
the Effect of the CALIGALOC Orthosis on Standing and Walking of Hemiparetic Patients With Ankle Varus

To assess the benefit of an anti-varus ankle foot orthosis (CALIGALOC, Bauerfeind) on gait and balance parameters in hemiparetic patients.


Eligibility Criteria:
Inclusion Criteria:

* Hemiparesis at \> 3 months (whatever the etiology)
* varus or equinovarus foot disturbing the stance phase of gait
* Able to walk at least 10m, with or without assistive device

Exclusion Criteria:

* unable to walk 10m
* Botulinum toxin injection less than 3 months before inclusion
* history of neurological or locomotor pathology in addition to the etiology of hemiparesis
* Severe comprehension troubles
* Pregnancy
Implementing a Postoperative MIRP (Minimally Invasive Repair of Pectus) Program Via Tele-monitoring

MIRP (Minimally Invasive Repair of Pectus) as surgical correction of pectus excavatum or carinatum is performed to achieve physiological, cosmetic, and psychological benefits for the patient. Surgery is often associated with severe postoperative pain. In this study the researchers want to registrate pain, sleep, nausea/vomiting, and daily activities in short and long term follow up.

In order to provide pain patients with an individualized approach to their pain problem after MIRP we developed an electronic medical record coupled to a set of telemetric medical-grade devices. Appi@Home (Antwerp Personalized Pain Initiative) supports an innovative approach to (sub)acute conditions by offering a platform for continuous follow-up. Patients are provided with a toolbox and an app that continuously collects objective outcome data (i.e. pain intensity, sleep quality, physical activity). The integrated system allows the care givers to respond very quickly to changing clinical conditions of the patient, making a very adaptive and individualized follow-up possible for these patients. In addition, the patient becomes an active participant in the global therapeutic approach.

Patients receive the toolbox two week prior to surgery with access to the internet platform for questionnaires fill-in procedure. Up to ten week after surgery pain intensity, sleep quality and physical activity will be monitored subjectively by a scoring table (0-10, 0 no pain-bad sleeping quality-no activity, 10 maximum of pain-excellent sleeping quality- a lot of activity) and objectively by blood pressure device, oxygen saturation monitoring, activity tracker and sleep registration tool.

Eligibility Criteria:
Inclusion Criteria:

* elective pectus repair
* signed informed consent

Exclusion Criteria:

* chronic opioid use (\> 3 months)
* history of ongoing psychiatric disease
Radiological Investigation of Bile Duct Obstruction

Patients with gallstone disease should be checked whether a common bile duct (CBD) stone could be present. In case of a certain suspicion for CBD stones further investigations should be performed. This can either be done by magnetic resonance cholangio-pancreaticography (MRCP) or by intraoperative cholangiography. The study investigates which pathway would be favorable in regard of an early hospital demission.

Patients with gallstone disease and suspected bile duct obstruction can be investigated either with a magnetic resonance cholangio-pancreaticography (MRCP) prior to gallbladder removal or with an intraoperative cholangiography during cholecystectomy. When detecting an common bile duct (CBD) stone in MRCP, normally endoscopic removal is performed before an operation. When the CBD stone is detected during gallbladder removal instead, endoscopic retrograde cannulation of the pancreatic duct (ERCP) will follow after the operation. Investigators hypothesize that direct operation shortens the length of hospital stay. Therefore investigators randomize patients with elevated Bilirubin, elevated liver enzymes (two of the following: aspartate transaminase (ASAT), alanine aminotransferase (ALAT), gamma-glutamyltransferase (gGT) or AP), suspected CBD stones in ultrasound or dilated common bile ducts either in MRCP first or operation first pathway. All data (patient admission to discharge, ...) will be entered in an online database

Eligibility Criteria:
Inclusion Criteria:

* Patients presenting as regular admission or at the emergency department (ED) with cholecystolithiasis and suspected CBD stones. The indication for CBD investigation requires one of the following features:

  i. Elevated bilirubin ii. ASAT/ALAT or gGT or aP above the normal range (two of them) iii. Choledocholithiasis in ultrasound iv. Dilated bile ducts in ultrasound
* Written informed consent

Exclusion Criteria:

* Age under 18 years
* Patients with biliary pancreatitis (due to the fact that conservative treatment is initiated before gallbladder removal and therefore leads to a prolonged hospital stay)
* Septic patients due to cholangitis
* Patients unable to consent
* Patients with medical conditions preventing surgery
* Pregnancy
* Radiologically proven CBD stone
Chronic Kidney Disease Progression in Chronic Hepatitis B Patients on Tenofovir Alafenamide (TAF) Versus Entecavir

Tenofovir alafenamide (TAF), a novel prodrug of tenofovir (TFV), has been approved for the treatment of chronic hepatitis B virus (HBV) infection. TAF has been shown to be a potent inhibitor of HBV replication at a low dose, with high intracellular concentration and more than 90% lower systemic TFV concentration than tenofovir disoproxil fumarate (TDF). TAF has been approved in the clinical practice guidelines in the west. Since its availability in Asia in 2017, there have been evolving data concerning its positive impact on renal safety as shown in registration trials.

The primary objective of this study is to compare the risk of chronic kidney disease (CKD) progression in chronic hepatitis B patients on TAF versus ETV in a territory-wide cohort in Hong Kong.

Antiviral therapy with nucleos(t)ide analogues (NAs) has revolutionized the management of chronic hepatitis B (CHB) in the last two decades.1 Entecavir (ETV), a nucleoside analogue, is one of the first-line NAs recommended by all international treatment guidelines.2-4 As hepatitis B surface antigen (HBsAg) seroclearance rarely occurs, most patients require long-term, if not life-long, NA therapy. Hence, the safety of NAs requires careful scrutiny. In clinical trials, nephrotoxicity may occur in a small proportion of patients receiving nucleotide analogues. We previously demonstrated that tenofovir disoproxil fumarate (TDF) was associated with mild renal impairment in a minority of patients; those treated with entecavir (ETV) had a similar risk compared to untreated patients.5

Tenofovir alafenamide (TAF), a novel prodrug of tenofovir (TFV), has been approved for the treatment of chronic hepatitis B virus (HBV) infection. TAF has been shown to be a potent inhibitor of HBV replication at a low dose, with high intracellular concentration and more than 90% lower systemic TFV concentration than tenofovir disoproxil fumarate (TDF). TAF has been approved in the clinical practice guidelines in the west. Since its availability in Asia in 2017, there have been evolving data concerning its positive impact on renal safety as shown in registration trials.

Eligibility Criteria:
Inclusion Criteria:

* Positive hepatitis B surface antigen (HBsAg) or documented history of CHB for 6 months or more; AND
* On TAF 25 mg daily as antiviral treatment for CHB (cases); OR
* On ETV 0.5 to 1.0 mg daily as antiviral treatment for CHB (controls)

Exclusion Criteria:

* Previous NA treatment prior to TAF or ETV
* Positive antibody against hepatitis C, D, or human immunodeficiency virus (anti-HCV, anti-HDV, or anti-HIV)
* Evidence of other autoimmune or metabolic liver diseases (except non-alcoholic fatty liver disease).
* Moribund state including advanced/pre-terminal liver cancer or other non-hepatic cancers
* Non-hepatic cancer undergoing chemotherapy within last 6 months
The Cardiovascular Genetic and Therapeutic Implications of Muscular Dystrophy

This study will have significant impact on muscular dystrophy patients as it promotes early screening for heart disease. With early identification, beneficial medical therapy can be started sooner, resulting in restoring and maintaining normal heart function. This is critical to the survival of these patients. We have reported previously that heart failure in all patients may have common mechanisms, the "final common pathway". Heart failure is a significant health problem with 5 million people in the US carrying the diagnosis and accounting for 12-15 million office visits and 6.5 million hospital days per year. The number of deaths from heart failure continues to increase. The data from this study could impact patients worldwide with heart failure by offering new insight into an ever-growing disease population and lead to significant changes in how they are currently treated.

Objective(s) and Hypothesis(es): The objectives to be evaluated are as follows:

Specific Hypothesis #1: Heart disease, specifically dilated cardiomyopathy, can be identified early in patients with muscular dystrophy and allow for earlier institution of medical therapies

Specific Hypothesis #2: Non-invasive testing via magnetic resonance imaging (MRI) and echocardiography can identify early systolic and diastolic dysfunction in patients with muscular dystrophy as well as document structural changes ("Reverse remodeling") following institution of medical therapy

Specific Hypothesis #3: Serologic testing can identify early cardiac dysfunction prior to changes on magnetic resonance imaging or echocardiogram that can predict disease onset, risk stratify future cardiac morbidity and mortality, and response to medical therapy

Specific Hypothesis #4: Specific dystrophin mutations can be identified that predict the onset or protection against dilated cardiomyopathy

Specific Hypothesis #5: Construction and maintenance of a database of patients with muscular dystrophy can be established that will allow for future research in patients with muscular dystrophy, specifically in the area of gene therapy

Specific Hypothesis #6: Quality of life in patients with cardiac disease can be assessed and used to modulate therapy and also allow for noncardiac directed therapies that will improve overall well-being

Specific Hypothesis #7: Further understanding of neurohormonal profiles, responses to medical therapy, and dystrophin mediated cardiomyopathy will impact all patients with heart failure world-wide

Eligibility Criteria:
Inclusion Criteria:

* All patients with the diagnosis of muscular dystrophy.

Exclusion Criteria:

* Patients that do not carry the diagnosis of muscular dystrophy.