cyrilzakka/clinical-trials huggingface dataset:
Natural History of Non Alcoholic Fatty Liver Disease and Predictors of Advanced Fibrosis

The prevalence of non-alcoholic fatty liver disease (NAFLD ) in the American population is approximately 30% in adults and 10% in children, making it the most common. Cause of chronic liver disease in the United States. Although the majority of patients with NAFLD have a benign clinical course, the development of non-alcoholic steatohepatitis (NASH ), with necro-inflammation and progressive fibrosis, increases the risk for development of cirrhosis and its complications. Among patients with NASH, approximately 28% develop cirrhosis over an 8-year follow-up period. NASH and advanced fibrosis is associated with increased morbidity and mortality among those patients with advanced histologic severity such as NASH and fibrosis the gold standard for diagnosing and staging NAFLD is liver biopsy. Liver biopsy is associated with costs and risks that make it impractical for generalized use in a condition that affects such a high portion of the population. Furthermore, liver biopsy is also limited by significant sampling error in NAFLD. Thus, there is a pressing need for accurate non-invasive predictors of NAFLD that would also allow differentiation of those subjects at higher risk of disease progression. At present, in the clinical setting, some demographic factors, blood tests, and imaging studies can be used to predict a higher risk of disease in patients being evaluated for NAFLD. These predictors, however, are of limited sensitivity and specificity compared with liver biopsy. The development and validation of accurate predictors and scoring systems to identify patients at higher risk for NASH and fibrosis would allow identification of subjects who would benefit the most from liver biopsy and potentially help monitor disease

It is a retrospective chart review study. All Methodist Dallas Medical Center (MDMC) patients with fatty liver diseases meeting the inclusion and exclusion criteria as mentioned below will be included in the study. Charts from Jan 2000 - Jan 2019 will be reviewed for data collection.

Data variables: age, weight, Height , BMI, gender, AST, ALT, Bilirubin, albumin, Alkaline phosphatase, WBC, PLT, Hb, sodium, potassium, creatinine, ferritin, insulin, glucose , HDL, LDL,VLDL, cholesterol, triglyceride. CT imaging, ultrasound findings, fibroscan, MR-Elastrography, liver biopsy results, presence of comorbidities like diabetes, hypertension and dyslipidemia

Eligibility Criteria:
Inclusion Criteria:

* All patients both male and female greater than 18 years with radiologic or histologic evidence of fatty liver will be included in the study.

Exclusion Criteria:

* Patients with history of fatty liver less than 18 years of age.
* Patient's with fatty liver consuming alcohol up to greater than one drink per day.
* All fatty liver patients with other chronic liver disease such as hepatitis B, hepatitis C, primary biliary cirrhosis, primary biliary cholangitis, autoimmune hepatitis, alpha one antitrypsin disease or Wilsons disease superimposed on fatty liver disease.
Activity-Based Therapy and Transcutaneous Spinal Cord Stimulation After Spinal Cord Injury (ABT-TCSCS)

The ABT-TCSCS study investigates how feasible and beneficial are activity-based therapy and transcutaneous spinal cord stimulation on improving of arm and hand recovery after cervical spinal cord injury.

The ABT-TCSCS is a one-arm interventional study evaluating the feasibility and efficacy of activity-based therapy and transcutaneous spinal cord stimulation on neurorestoration of upper limbs after cervical spinal cord injury. Up to 24 individuals with SCI who suffer from tetraplegia will be treated with ABT-TCSCS. All participants will receive 12 sessions of ABT (4 weeks), followed by 28 sessions of ABT-TCSCS (7 weeks). Each session will last 1 hour and delivered 3 times per week. All study participants will be assessed at the start of the study (Baseline 1) and then re-assessed after 6 weeks (Baseline 2) to ensure that they are neurologically stable. The baseline assessment will consist of the International Standards of Neurological Classification of SCI (ISNCSCI), GRASSP Version 1, the Spinal Cord Independence Measure (SCIM) and the TRI hand function test (TRI-HFT). Participants will be re-assessed after receiving 12 sessions of ABT i.e after 4 weeks (Pre-cervical stimulation assessment) and then after receiving 28 sessions of combined ABT and neuromodulation i.e after 7 weeks (Post-intervention assessment).

Eligibility Criteria:
Inclusion Criteria:

* Individuals with chronic traumatic and non-traumatic cervical SCI (ASIA classification A-incomplete\*\*, B, C, D) between C1-C8
* Adults more than 18 years old
* At least 6 months post-spinal cord injury
* A score of 2 - 15 on the upper extremity motor score of the ISNCSCI
* A score between 5 - 40 on GRASSP Version 1 Strength on at least one side
* Individuals who are medically stable

Exclusion Criteria:

* Individuals with any other upper extremity deficit
* Unable to provide informed consent
* Unable to participate in an intensive rehabilitation outpatient program
* Spasticity that limits the range of motion greater than 50% for the elbow or wrist
Reduced Exposure Study in Smokers Using the Tobacco Heating System 2.2 (THS 2.2) for 5 Days in a Confinement Setting

The overall goal of the study is to evaluate if the ad libitum use of the Tobacco Heating System 2.2 (THS 2.2) for 5 consecutive days by adult Japanese healthy smokers affects the levels of biomarkers of exposure for selected harmful and potentially harmful constituents (HPHCs) compared to smoking conventional cigarettes (CC) and smoking abstinence (SA).


Eligibility Criteria:
Inclusion Criteria:

* Subject is Japanese.
* Smoking, healthy subject as judged by the Investigator.
* Subject smokes at least 10 commercially available non-menthol CCs per day (no brand restrictions) for the last 4 weeks, based on self reporting.
* Subject has smoked for at least the last 3 consecutive years.
* Subject does not plan to quit smoking in the next 3 months.

Exclusion Criteria:

* As per Investigator judgment, the subject cannot participate in the study for any reason (e.g., medical, psychiatric, and/or social reason).
* The subject has received medication within 14 days or within 5 half-lives of the medication (whichever is longer), which has an impact on CYP1A2 or CYP2A6 activity.
* For women: Subject is pregnant or is breast feeding.
* For women: Subject does not agree to use an acceptable method of effective contraception.
Clinical and Functional Outcome of the Gemini SL Fixed Bearing at Midterm Follow-up

This is a retrospective, multicenter case series with a prospective follow-up to confirm the safety and performance of the Gemini SL Fixed Bearing knee prosthesis in midterm follow-up under routine conditions. Primary outcome of the study is the 5-year survival rate of the Gemini SL Fixed Bearing knee prosthesis with revision for any reason as the end point.

Sufficient data (e.g. biomechanical tests, biocompatibility, vigilance data and results of risk management, clinical data of comparable devices) are available for assessing the safety and performance of the Gemini SL knee prosthesis system. Unfortunately, no data are available for the Gemini SL Fixed Bearing knee prosthesis. As one part of the post market surveillance (PMS) system of the sponsor, the clinical outcome of the Gemini SL Fixed Bearing knee prosthesis in the midterm follow-up shall be evaluated. Therefore patients who received a Gemini Sl Fixed bearing knee prosthesis 3 years ago are invited to participate in follow-up examinations.

Eligibility Criteria:
Inclusion Criteria:

* Implantation of a Gemini SL Fixed Bearing knee prostheses 3 years ago
* Age between 18 and 75 years at the time of implantation

Exclusion Criteria:

* Body Mass Index (BMI) \> 40 kg/m² at the time of implantation
* Comorbidities and known medical circumstances which would affect the clinical functional outcome after implantation of the knee prosthesis (e.g. neurological or musculoskeletal diseases) at the time of implantation
* Prisoner
SEBBIN Round, Anatomical and Biconvex Gluteal Implants

This study is part of the clinical evaluation of SEBBIN silicone gel-filled gluteal implants, included in the technical file of the device. The aim of the study is to gather additional data about the safety and effectiveness of the device.


Eligibility Criteria:
Inclusion Criteria:

* The patient is a man or a woman ≥ 18 years old at the time of inclusion.
* The patient is planned for a unilateral or bilateral gluteal implant placement with SEBBIN implants as per investigator decision
* The patient has been informed of the study, has read the patient informed consent and provided consent for the study in writing.

Exclusion Criteria:

* Patient implanted with silicone implants somewhere else in the body.
* Patient candidate for implantation with custom-designed implants.
* Participation in another interventional clinical study (participation into an observational study is permitted) with a medicinal product or a medical device in the 30 days prior to enrolment.
The Effect of Music in the Pediatric Emergency Department Waiting Room on Caregiver Anxiety

The purpose of this research study is to examine the effects of playing classical music in the waiting room on caregiver anxiety. People who enter the study will be asked a few identifier questions including age and relation to patient and then will be asked fill out a survey regarding anxiety.

The study investigators will initially screen for participants based on the patient's acuity level. If the patient meets the low acuity requirement and if they have a wait time greater than 20 minutes then the caregiver will be approached to obtain informed consent once they have been placed in a room. If they choose to be included in the study, the patient's medical record number will be recorded, a personal identification number will be assigned, and the patient's information will be entered into the personal identification number key and into our research database. A questionnaire asking participants age and relation to patient and the state-trait anxiety inventory will be administered to the caregiver. An additional question of perceived wait time will also be asked.

Eligibility Criteria:
Inclusion Criteria:

* Adult caregivers; age \>18 year, accompanying a pediatric patient with acuity level ≥ 4
* Patient must have been in waiting area for at least 20 minutes

Exclusion Criteria:

* Non-english speaking caregivers
* Hearing impaired caregivers
* Caregivers accompanying a patient with an acuity level less than 4
Intraosseous Morphine Administration During Anterior Cruciate Ligament Reconstruction

The purpose of this study is to determine if intraosseous (IO) morphine decreases pain and post-operative opioid use in patients undergoing anterior cruciate ligament (ACL) reconstruction.


Eligibility Criteria:
Inclusion Criteria:

* Patients of the IRB approved surgeon(s) undergoing ACL reconstruction with bone-to-bone (BTB) autograft
* Patients aged between 18-40 years old at the time of surgery

Exclusion Criteria:

* Patients undergoing ACL reconstruction with any other type of autograft or allograft other than BTB
* Patients younger than 18 years old or older than 40 years old
* Patients undergoing meniscal root repair or any other repair that changes their weight-bearing status
* Patients with a history of substance abuse
* Vulnerable populations
* Patients on chronic pain medication within the last 6 months
* BMI \>/= 35
* Allergy to morphine
* Unwilling to participate
* Any additional reason the PI deems reasonable
Effect of Fee on Attendance in Cervical Cancer Screening

Several reasons can explain non-attendance in cervical cancer screening. In low resource settings the attendance is even lower. The effect of fee as contributing reason of non attendance has not been studied before why the investigators decided to study this in a low resource setting as a randomised trial.

Non-attendance in the cervical cancer screening programme is the most important factors why Swedish women contract the disease. Low attendance rate is observed in districts with low socioeconomic resources. Several reasons can explain this, including the existence of a fee. A low attendance rate in low resource districts is also noticed in Gothenburg, Sweden. After multiple interventions the coverage has slightly increased. None of the interventions included the aspect of the fee. The investigators decided to study the effect of fee abolishment in a randomized control trial emanating from the regular cervical cancer-screening program. Method: Randomized Control Trial (RCT). Women in low resource areas of Gothenburg, due for screening, January-July 2013, were randomised to receive an offer of a free test or receiving the regular invitation stating the regular fee of 100 Swedish kronor (SEK) (≈11 €). Power calculation has shown 80 % power to detect an increase in participation of 20% at 1972 participants.

Eligibility Criteria:
Inclusion Criteria:

* All women in the designated geographical area, consecutively enrolled in planned screening according to standard routine. I.e women are invited if they are between 23 and 60 years of age and don't have a pap smear registered the last three or five years according to age.

Exclusion Criteria:

* None
Valproic Acid in Childhood Progressive Brain Tumors

The study investigates valproic acid added to radiation and temozolomide therapy (standard of care) for progressive or recurrent pediatric brain tumors.

Patients with progressive or recurrent pediatric brain tumors are administered valproic acid, an HDAC inhibitor, along with standard of care therapy (radiation and temozolomide) for induction therapy. Thereafter, patients will be able to continue on valproic acid and temozolomide therapy as long as the combination is well tolerated and the tumor is not progressing.

Eligibility Criteria:
Inclusion Criteria:

* Subject, parent, or guardian willing and able to give informed consent
* Recurrent or progressive pediatric brain tumor, with MRI evidence of disease
* Age at first diagnosis of brain tumor 1-21 years old
* Lansky or Karnofsky performance score of at least 50 at diagnosis

Exclusion Criteria:

* Pregnancy
* Prior intolerance to valproic acid
* History of use of temozolomide
* Use of enzyme inducing anticonvulsant medications (see appendix B)
* Known urea cycle disorder (e.g. ornithine transcarbamylase deficiency)
Management of Post Endodontic Re-treatment Pain With Low-Level Laser Therapy

In this clinical trial investigators aimed to evaluate Post endodontic re-treatment pain after irradiation of low level laser therapy

In this clinical trial, 61 patients requiring endodontic retreatments in the posterior teeth were selected. A single visit Endodontic retreatment was done. After biomechanical preparation, Low Level Laser was irradiated to the buccal and lingual mucosa overlying the apices of the target tooth in the experimental group. In the control group patients received placebo laser to eliminate the probable psychological effects of laser. Laser irradiation was done with a single dose of 808 nm wavelength (Whitening Lase II- Laser DMC, Samsung, Korea) with 100 mw power, and dose of 70 J/cm2 for 80 seconds. Pain severity was recorded before the treatment, immediately after the treatment and 4, 8, 12, 24 and 48 hours after the treatment by visual analogue scale (VAS). The pain scores were statistically analyzed by chi-square test between two groups. The effects of different variables on the post-operative pain experience were also studied by means of Logistic regression.

Eligibility Criteria:
Inclusion Criteria:

- patients requiring endodontic retreatments in the posterior teeth

Exclusion Criteria:

* systemic diseases psychologic disorders
Safety and Dose Study of GRN163L Administered to Treat Patients With Refractory or Relapsed Multiple Myeloma

The purpose of this study is to determine the safety and the maximum tolerated dose (MTD) of GRN163L when administered to patients with refractory or relapsed multiple myeloma.

GRN163L is a telomerase template antagonist with in vitro and in vivo activity in a variety of tumor model systems. Telomerase is an enzyme that is active primarily in tumor cells and is crucial for the indefinite growth of tumor cells. Inhibition of telomerase may result in antineoplastic effects.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of multiple myeloma (either secretory or nonsecretory disease)
* Relapsed or refractory disease
* At least two prior treatment regimens
* ECOG performance status 0-2
* Adequate hepatic/renal function and platelet count
* If previously treated with an anthracycline, anthracenedione, or trastuzumab, must have left ventricular ejection fraction \> 50%

Exclusion Criteria:

* Prior allogeneic bone marrow transplant, including syngeneic transplant
* Known intracranial disease or epidural disease
* Prior malignancy (within the last 3 years)
* Clinically significant cardiovascular disease or condition
* Active or chronically recurrent bleeding (eg, active peptic ulcer disease
* Prolongation of PT or aPTT \> the ULN or fibrinogen \< the LLN
* Clinically relevant active infection
* Serious co-morbid medical conditions, including cirrhosis and chronic obstructive or chronic restrictive pulmonary disease
* Symptomatic hyperviscosity syndrome
* Any other cancer therapy within 3 weeks prior to study, except for mitomycin C, nitrosoureas, or high-dose chemotherapy with stem cell support within 6 weeks prior to study
* Investigational therapy within 4 weeks prior to study
* Anti-platelet therapy within 2 weeks prior to study, other than low dose aspirin prophylaxis therapy and low dose heparin administration for management of IV access devices
* Radiation therapy within 4 weeks prior to study
* Major surgery within 4 weeks prior to study
* Active autoimmune disease requiring immunosuppressive therapy
* Known positive serology for HIV
Enteral Nutrition and Glycemic Variability Neurological Intensive Care Unit Study

Primary Objective:

To determine the effects of a diabetes specific enteral formula compared to a standard formula supplemented with protein (isocaloric and isonitrogenous) on the mean blood glucose and glycemic variability in a homogenous group of critically ill patients in a neurological ICU. Blood glucose will be recorded every minute using a continuous blood glucose monitor. The primary end points will be the difference between the mean blood glucose levels and the glucose variability between the control and intervention groups for the time period that the patient is in the ICU and receiving tube feeds and for up to a maximum of 14 days.

Secondary Objectives:

To determine the effects of the diabetes specific versus standard tube feeds on the change in muscle thickness and volume measured by 2-dimensional ultrasound imaging during the patients ICU stay.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged between 18 and 89 years old
* Patients with critical illness including ischemic or hemorrhagic stroke, epidural/subdural bleeds and subarachnoid hemorrhage
* Patients who are expected to stay in the ICU for at least 5 days
* Hyperglycemia is not an inclusion criteria

Exclusion Criteria:

* Patients who have received or will be treated with systemic corticosteroids.
* Patients who will be receiving high doses of propofol (\>40 cc/hr)
* Patients with type 1 Diabetes
* Patients with sepsis or acute trauma
* Patients with an expected stay in the ICU of less than 4 days
* Patients who are unable to receive enteral nutrition or who have medical conditions precluding nutrition by the enteral route including allergies to formula components
* Pregnant and lactating patients
* Patients with prior history of gastroparesis
* Patients with acute kidney failure (creatinine \> 2.5mg/dl)
* Patients with acute liver failure (bilirubin \> 2.0 mg/dl)
Growth and Tolerance of Cow's Milk-Based Infant Formulas

This clinical trial will evaluate the growth, tolerance, and iron status of infants who consume an investigational infant formula containing a nutrient-rich whey protein compared to a previously marketed infant formula.


Eligibility Criteria:
Inclusion Criteria:

* Singleton, 10-14 days of age at randomization
* Term infant with birth weight of a minimum of 2500 grams
* Solely formula fed
* Signed Informed Consent and Protected Health Information

Exclusion Criteria:

* Anemia at time of birth
* Current use of iron or iron-containing supplements
* History of underlying metabolic or chronic disease or immunocompromised
* Feeding difficulties or formula intolerance
A Renal Impairment Study for PF-04965842

This study is a phase 1 non-randomized, open-label, single-dose, parallel-group study of PF 04965842 in subjects with severe renal impairment and subjects without renal impairment (Part 1) and in subjects with moderate renal impairment (Part 2).

This is a Phase 1 non randomized, open label, single dose, parallel cohort, multisite study to investigate the effect of renal impairment on the pharmacokinetics, safety and tolerability of PF-04965842 after a single 200 mg oral dose. Subjects will be selected and categorized into normal renal function or renal impairment groups based on their estimated glomerular filtration rate. Part 1: A total of approximately16 subjects will be enrolled; approximately 8 subjects with severe renal impairment and approximately 8 with normal renal function. After statistical evaluation of results from Part 1, Part 2 may be conducted and approximately 8 subjects with moderate renal impairment will be enrolled. The total duration of participation from the Screening Visit to Day 4 will be a maximum of 31 days and from the Screening Visit to Follow-up Contact/Visit will be a maximum of 67 days.

Eligibility Criteria:
Inclusion Criteria:

* Breath alcohol test at Screening and Day -1 must be negative.
* Body mass index (BMI) of ≥ 17.5 to ≤ 40.0 kg/m2; and a total body weight \>50 kg (110 lb).

Additional inclusion criteria for subjects with renal impairment:

* Meet the following eGFR criteria during the screening period based on the MDRD equation:

  * Severe renal impairment: eGFR \<30 mL/min, but not requiring hemodialysis.
  * Moderate renal impairment (Part 2 only): eGFR ≥30 mL/min and \<60 mL/min.
* Any form of renal impairment except acute nephritic syndrome (subjects with history of previous nephritic syndrome but in remission can be included).
* Stable concomitant drug regimen.

Exclusion Criteria:

* Renal transplant recipients.
* Urinary incontinence without catheterization.
* Subjects with clinically significant infections within the past 3 months (for example, those requiring hospitalization, or as judged by the Investigator), evidence of any infection (including influenza) within the past 7 days prior to baseline, history of disseminated herpes simplex infection or recurrent or disseminated herpes zoster.
* Subjects with a malignancy or with a history of malignancy, with the exception of adequately treated or excised non-metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ.
* History of or current positive results for human immunodeficiency virus, Hepatitis B, Hepatitis C.

Additional exclusion criteria for subjects with renal impairment:

* Subjects requiring hemodialysis and peritoneal dialysis.
* Screening BP ≥ 180 mm Hg (systolic) or ≥ 110 mm Hg (diastolic).
* Screening supine 12-lead ECG demonstrating QTcF \>470 msec or a QRS interval \>120 msec.