cyrilzakka/clinical-trials huggingface dataset:
Prevalence, Incidence and Characteristics of NAFLD/NASH in Type 1 Diabetes Mellitus

Nonalcoholic fatty liver disease (NAFLD) is a condition characterized by intrahepatic fat accumulation. It is closely related to insulin resistance. To date, it remains unclear whether NAFLD is common in patients with type 1 diabetes or if NAFLD translates into an increased health burden in this population. Screening for NAFLD is challenging due to the limitations of non-invasive diagnostic tools.

Liver biopsy remains the gold standard but is not suited for routine screening or clinical studies. Therefore, there is a great demand for accurate non-invasive screening tools that can not only diagnose but also stage NAFLD. This study aims to generate a large cohort of thoroughly characterized type 1 diabetes patients screened for NAFLD using multiple non-invasive tools including MRI, ultrasound, controlled attenuation parameter, and score panels. We aim to generate a biobank to promote a research collaboration network in the field of non-invasive diagnosis of NAFLD.

A secondary endpoint is to investigate the potential correlation between the presence of NAFLD and the occurrence of micro-or macrovascular complications in patients with diabetes.

This study aims to characterize and follow a thoroughly characterized cohort of adult type 1 diabetes patients free from secondary liver disease due to excessive alcohol usage, viral hepatitis, alfa-1 antitrypsin deficiency, Wilson's disease or steatogenic or hepatotoxic drug use.

The investigators will screen for NAFLD and fibrosis using multiple non-invasive techniques including

* ultrasound
* controlled attenuation parameter
* fatty liver index
* human steatosis index
* transient elastography
* FIB-4
* NAFLD fibrosis score
* NASH algorithm based on multiple parameters

Subjects will be screened for microvascular and microvascular complications with:

* ECG
* microfilament examination
* 24hour urine collection for microalbuminuria
* serum kidney test (creatinine, eGFR)
* fundoscopy
* peripheral arterial pulsation palpation

The investigators will subsequently thoroughly characterize various metabolic and anthropometric parameters and document any microvascular or macrovascular complications.

The patients will be annually rescreened for both NAFLD-related as cardiovascular variables. Therefore this study will assess the correlation between NAFLD, cardiovascular risk, and type 1 diabetes in a prospective manner.

Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes
* Adult age
* Informed consent given

Exclusion Criteria:

* Secondary liver disease
* Excess alcohol usage
* Pregnancy
* Use of steatogenic medication
* Active cancer or oncological treatment
* History of organ transplantation
Metabolic Impact of Time Restricted Feeding

The investigators are interested in how time-restricted feeding will impact weight, sleep duration and efficacy, and activity levels in obese adults. Significant advances in digital mobile technology allow detailed measures of an individual's habits, permitting the opportunity for personalized dietary and lifestyle recommendations. This is especially relevant as time-restricted feeding appears to promote weight loss independent of calorie intake, potentially shifting the paradigm of dietary recommendations from a calorie-based to a time-based perspective.

Given the obesity epidemic, there is intense medical and public interest in dietary and lifestyle management to mitigate obesity and its associated complications. Although weight loss has traditionally focused on restricting calories, it is well described that most people are unable to maintain the caloric restriction required to long term weight loss or maintenance. This proposal will address whether restricting the timing of food intake, rather than restricting calories, may facilitate weight loss and provide metabolic benefits. It has been recently shown that the average American eats over the course of 15 hours per day. Such an eating cycle dictates that most people are always in a fed metabolic state and likely misaligns circadian patterns. Time-restricted feeding (TRF) is the process of limiting food consumption to a specific window of time (e.g. 8 hours per day) and is associated with weight loss in humans and metabolic improvements in rodent studies. Significant advances in digital mobile technology now allow further detailed measures of an individual's habits to facilitate this analysis. Thus, the objective of this study is to test the health related effects of 12 week TRF (8 hour fed and 16 hour fasting cycle) in overweight/obese adults. The investigators hypothesize that TRF will 1) improve sleep duration, sleep efficacy, increase activity and increase basal metabolic rate, 2) promote weight loss and lower body fat, and 3) improve insulin sensitivity and postprandial hyperglycemia. The investigators expect these studies to show that TRF is effective and sustainable approach to improving metabolic parameters in overweight/obese individuals.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18-65
2. BMI ≥ 25
3. Stable sleep and work schedule
4. Owns a smart phone
5. Capable of giving informed consent

Exclusion Criteria:

1. Pregnant
2. Nursing
3. Anticipation of pregnancy during the course of the study
4. Clinically significant medical issues as determined by the study clinician
The Effect of Pancreatic Polypeptide on Insulin Requirements for Type 1 & Post-pancreatectomy Diabetic Patients

The goal of this research is to see if pancreatic polypeptide (PP), a hormone that is naturally produced by the pancreas and that works to control the amount of glucose that the liver makes, will reduce the amount of insulin required for people who must take insulin to maintain their normal blood glucose level.

The pancreas is a large gland located behind the stomach. One of the functions of the pancreas is to produce two hormones: insulin and pancreatic polypeptide. Insulin helps the cells to take in glucose. The liver makes glucose and insulin normally acts to decrease or shut off the liver's production of glucose. However, in patients whose pancreas no longer makes insulin or makes low levels of pancreatic polypeptide the liver cannot perform these duties as well. Studies have shown that these important functions of the liver are improved for these patients when pancreatic polypeptide is given together with their insulin. Because PP increases the liver's sensitivity to insulin and thereby reduces the amount of glucose produced by the liver, this will result in fewer swings in blood sugar levels both in the upper and lower range. With fewer swings in blood glucose, a patient should decrease the amount of insulin used. One of the main benefits of lowering total insulin requirement is a reduction in the development of dangerous low blood sugar levels.

Eligibility Criteria:
Inclusion Criteria:

* Male and female volunteers between the ages of 18-75 with:
* 10 subjects who are status post pancreatic resection and 10 volunteers who are Type 1 diabetic for \> 8 years (volunteers must have a stable glycemic profile that includes use of an insulin pump to control their blood glucose) with or without prior pancreatic resection.
* HbA1c levels ≤ 8.5.

Exclusion Criteria:

* Lactating or pregnant females.
* Brittle or Labile diabetics: Volunteers with extremely erratic patterns of glucose control with large fluctuations in glucose levels for no obvious reason.
* Allergy to beef or beef by-products.
* Hypoglycemia within the past year requiring medical or other assistance to correct.
* Known autonomic neuropathy.
* Documented blood glucose under 60 mg within the past year and hypoglycemic unawareness.
* Durations of type 1 Diabetes Melitis (DM) ≤ 8 years.
* Not currently on pump therapy.
* Type 1 DM who has a BMI ≥ 35.
Supplemental Nicotine Administration for Smoking Cessation in Posttraumatic Stress Disorder (PTSD)

The investigators propose to evaluate the relationship between PTSD, mood, craving and withdrawal symptoms and factors associated with relapse in the context of a randomized clinical smoking cessation trial. The use of supplemental nicotine administration (SNA) during a "pre-treatment" phase before a targeted quit date is an innovative development in smoking cessation, and may be helpful in treating smokers with PTSD. The use of SNA during ad lib smoking for smokers with PTSD is predicted to reduce both the physiological and emotional dependence on inhaled nicotine, thereby increasing the odds of successful smoking cessation.

Smokers with PTSD will be randomly assigned to 1 of 2 pre-cessation patch therapy conditions (active patch versus placebo patch) for 2 weeks before a target quit-smoking date. All participants will receive brief cognitive-behavioral therapy (CBT) and will begin standard nicotine replacement therapy on their quit day. PTSD symptoms, mood, smoking craving and withdrawal symptoms will be evaluated using electronic diary assessment for one week prior to the pre-cessation period, during the 2-week pre-cessation period, and 6 weeks post quit date. The study is designed to address the following aims:

Specific Aim 1: To examine the effects of SNA on PTSD symptoms, mood, craving and withdrawal through electronic diary assessment.

Hypothesis 1.1. SNA will decrease craving for cigarettes during the 2 week pretreatment period as compared to the placebo patch condition.

Hypothesis 1.2. SNA will decrease the perceived improvement in mood and PTSD symptoms associated with smoking behavior.

Hypothesis 1.3. SNA during the pre-cessation period will result in a reduction of withdrawal symptoms following the quit-date.

Specific Aim 2: To evaluate the effect of SNA on quit rates among smokers with PTSD.

Hypothesis 2. SNA during the pre-cessation period will result in improved quit rates Specific Aim 3: To investigate potential predictors of relapse including PTSD symptom severity, mood, anxiety sensitivity, distress tolerance, and self-efficacy.

Hypothesis 3.1 - 3.5 Increased PTSD symptom severity, increased baseline negative affect, increased anxiety sensitivity, decreased distress tolerance, and lower self-efficacy each will independently be associated with shorter abstinence from smoking.


Eligibility Criteria:
Inclusion Criteria:

* between ages of 18 and 70
* smoker who has smoked 10 or more cigarettes per day during past year
* current PTSD
* English speaker
* study physician clearance

Exclusion Criteria:

* organic mental disorder, schizophrenia, current manic syndrome, lifetime but not current PTSD, or current substance abuse/dependence
* pregnancy
* unstable medications
* myocardial infarction in past 6 months
Comprehensive Medication Monitoring on Heart Failure Patient Outcomes

The purpose of this study is to evaluate the clinical utility of comprehensive medication monitoring using the Patient Medication Profile to improve heart failure patient medication therapy and associated outcomes relative to usual care in a hospital setting.

Congestive heart failure has an exceptionally high rate of hospital admission and is responsible for more re-admissions (23.5% at 30 days) in the United States than the 2nd and 3rd leading causes combined. Inadequate medication reconciliation both on admission and discharge from the hospital is a significant cause of medical error. In one study of cardiovascular patients, 44% believed they were taking a medication they were not, and 96% were unable to recall at least one medication they were taking. In the same study patients omitted on average 6.8 medications from their medication list. Medication optimization through improved adherence and reconciled medical records has been postulated to significantly improve admission and 30-day hospital readmission rates.

Sano has developed a blood-based comprehensive medication monitoring tool that identifies and quantitates 235 prescription drugs and drug metabolites. It does not detect illicit drugs. This tool, which produces an output report designated the 'Patient Medication Profile', is designed to be used with clinical decision support to improve medication adherence, reduce medication errors, and optimize medication therapy. For heart failure patients, the investigators hypothesize that deploying the Patient Medication Profile with clinical decision support at key points of treatment intervention will A) improve medication adherence, B) identify and reconcile significant discrepancies in the medication list, C) result in reduced hospital admissions, and D) result in better overall patient outcomes. These outcome expectations are relative to usual care for heart failure patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have a regularly scheduled visit to a University of Pittsburgh Medical Center (UPMC) cardiology clinic in Oakland
* Patients must have Heart Failure with Reduced Ejection Fraction (≤40%)
* Patients have admitted to UPMC hospital facility between one and five times in past 12 months
* Patients must be able to provide informed consent for present study
* Patient age \> 18 years

Exclusion Criteria:

* Enrolled in Hospice
* Patient on home inotrope (Dobutamine or milrinone)
* World Health Organization (WHO) Group 1 or Group 5 pulmonary hypertension
* Patient with current ventricular assist device (VAD)
* Not able to communicate in English
Survey Study for Pain Management, Wound Care, Scar Care or UDT

This is a survey study that will be given to patients who have been prescribed a topical compound for pain management, wound care or scar care or to patients who have been requested to do a urinary drug test (UDT) by their provider.

The initial survey for pain management, wound care, scar care or UDT will be given to the patient by their providers during their office visit.

We have designed a survey study that will be given to patients who have been prescribed a topical compound for pain management, wound care or scar care or to patients who have been requested to do a urinary drug test (UDT) by their provider.

The initial survey for pain management, wound care, scar care or UDT will be given to the patient by their providers during their office visit.

Follow-up surveys will be given at 30, 60, and 90 days. These surveys will be collected by e-mail or follow-up calls from Datum Research, LLC, contract research organization.

Data collection for this study will be derived through the 4 patient surveys (initial, 30 day, 60 day, and 90 day) and the prescription written by the provider.

The survey study will enroll patients until December 31, 2014, or until sufficient numbers have been achieved.

Rahm Foundation will continue the study until:

* Sufficient information has accumulated to meet the scientific objectives of the Study (i.e. numeric targets or effect size)
* The feasibility of collecting sufficient information diminishes to unacceptable levels, poor enrollment, loss to follow-up and/or
* Other methods of gathering appropriate information become achievable or are deemed preferable.

Datum Research will need to have access to the prescription to see what compound was prescribed.

Eligibility Criteria:
Inclusion Criteria:

* Prescribed a topical cream for pain, scar care, or wound OR Provider preforms urinary drug test

Exclusion Criteria:

* Subjects with legally authorized representatives
* Minors
* Prisoners
Mastoid Bone Autograft for Dorsal Nasal Augmentation

The purpose of this study is to evaluate the safety and efficacy of mastoid bone autograft for dorsal nasal augmentation in rhinoplasty.

INTRODUCTION: Several grafts and/or implants have been used for dorsal augmentation. In some cases, especially the traumatic, non-caucasian, and multi-operated ones, the amount of augmentation is higher than the usually available from septal and auricular conchal autografts.

OBJECTIVE: To evaluate the safety and efficacy of mastoid bone autograft for dorsal nasal augmentation in rhinoplasty.

DESIGN: A prospective study of 15 consecutive patients submitted to dorsal nasal augmentation with mastoid bone, during a 2-year period.

SETTING: One major academic medical center.

Eligibility Criteria:
Inclusion Criteria:

* Nasal acquired or congenital deformity of the dorsum that requires augmentation of more than 5 mm

Exclusion Criteria:

* Previous otologic surgery/disease
Point-of-Delivery Prenatal Test Results Through mHealth to Improve Birth Outcome

The investigators propose to adopt sustainable community networks (in this case churches) to implement an integrated community-based screening that incorporates mobile health technology (mHealth) to make prenatal test results available at the point-of-delivery to guide medical management.

The investigators will develop and test the feasibility, acceptability, and usability of a mobile health platform that captures results for HIV, Hepatitis B virus (HBV) and sickle cell genotype obtained from participants during the Healthy Beginning Initiative (HBI) program; store data in a secure, web-based database; encrypt data on a "smart card" which is given to participants, and make these data available at the point-of-delivery using a cell-phone application to read the "smart card". Data on the web-based database can also be accessed directly using the cell phone application. Evidence exists that when clinician have maternal records available at the point of delivery, they are more likely to initiate antiretroviral prophylaxis for HIV-exposed infants, administer the first dose of hepatitis B vaccine with 24 hours for infants born to women who have positive hepatitis B surface antigen and screen infants born to mothers with sickle cell trait to allow early identification and initiation of penicillin prophylaxis for infants who have sickle cell disease.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women; 18 years or older enrolled in the Healthy Beginning Initiative
* One of the three conditions - HIV, Hepatitis B, and Sickle cell trait/disease

Exclusion Criteria:

* Those who do not accept to have their information uploaded on the secure database
NUTRALYS® Pea Protein Oral Supplementation Effects on Muscle Mass

this clinical trial would try to confirm whether NUTRALYS®, a fast pea protein with an intermediate profile, rich in leucines and other essential amino acids, can significantly enhance muscle mass gain during strength training. This study will compare the efficacy of NUTRALYS® to a reference product. If the results of the study demonstrate a significant improvement in relation to the placebo, not inferior to that of whey, NUTRALYS® could be considered as an alternative to sports nutrition products, to which many people are intolerant.


Eligibility Criteria:
Inclusion Criteria:

* Male subjects from 18 to 35 years of age:
* engaged in moderate or occasional sports activity;
* having given their written informed consent;
* in gainful employment or a student;
* in possession of a medical certificate of fitness for sports

Exclusion Criteria:

* Subject already engaged in regular sports or training increasing muscle strength or volume in the upper limbs and particularly the biceps brachial;
* Subject engaged or having engaged in the last 6 months in weight training more than once a week;
* Subject having had a muscle injury in the 3 months prior to the study;
* Asthmatic subject liable to be administered corticosteroids;
* Subject taking part in another trial;
* Subject with a known hypersensitivity to whey or pea proteins;
* Subject deprived of their freedom for administrative, medical or legal reasons or not in possession of the legal or ethical capacity to enter into a contract due to cognitive function impairment;
* Subject liable not to comply with the constraints required by the protocol;
* Subject not covered by health insurance;
* Subject having taken in the previous month or currently taking: medication, a dietary supplement, sports drink, food for particular nutritional uses or functional foods, of any kind, liable or described as liable to increase physical performance and notably to increase muscle mass;
* Subject taking anabolic protein or corticosteroid treatment;
* Subject on a high-protein diet.
Information Transfer During Postoperative Handovers in the Post-anaesthesia Care Unit

Anaesthesiology plays a key role in promoting safe perioperative care. This includes the perioperative phase in the post-anaesthesia care unit (PACU) where problems with incomplete information transfer may have a negative impact on patient safety and can lead to patient harm. The objective of this study is to analyse information transfer during postoperative handovers in the PACU.

With a self-developed checklist information transfer during postoperative handovers will be documented and subsequently compared with patient information in anaesthesia records.


Eligibility Criteria:
Inclusion Criteria:

* All patients transferred to the PACU after surgery

Exclusion Criteria:

* Age \< 18 years
* patients who have surgery under local anaesthesia or in standby
* patients who are transferred to the surgical intensive care unit (SICU) after surgery
The VMVN Study: Virological Monitoring in Viet Nam

The purpose of the study is to test the hypothesis that the addition of routine viral load testing to the standard laboratory monitoring of HIV patients on first-line antiretroviral treatment (ART) in Vietnam will result in better clinical outcomes for patients.

The optimal strategy for monitoring antiretroviral therapy (ART) in resource-limited settings (RLS) is unknown. In developed countries, routine monitoring with CD4 count and viral load (VL) testing is standard practice. In RLS, however, limitations in the availability of the technology for VL testing, and in financial resources to pay for VL testing, mean that few developing countries provide VL testing as part of the routine monitoring of patients on ART. Instead, ART is monitored primary by clinical examination with CD4 testing where available. This strategy has been endorsed by the most recent WHO guidelines for ART (WHO, 2010).

Standard laboratory monitoring of patients on ART in Vietnam includes CD4 testing every 6 months, where available. In many rural areas of the country, CD4 testing is not available and only clinical monitoring is used.

In this study we will test the hypothesis that routine viral monitoring every 6 months for patients on first-line ART will result in significantly higher rates of virological suppression and decrease the incidence of death or new or recurrent AIDS-defining illnesses by 50% within three years.

Eligibility Criteria:
Inclusion Criteria:

* Age \>= 18
* Confirmed HIV infection
* Not currently taking ART
* Meets Vietnam MOH criteria for ART (THROUGH OCTOBER 2011:CD4\<250 cells/mm3, WHO Clinical Stage IV, or WHO clinical stage III with CD4\<350 cells/mm3; FROM NOVEMBER 2011: CD4\<350 cells/mm3, OR WHO Clinical Stage III or IV)
* Completes required Vietnam MOH ART adherence training
* Signs written informed consent form

Exclusion Criteria:

* Any ART use within the previous 3 months
* History of treatment failure on first-line ART or known resistance to first-line ART.
* Unable or unwilling to give written informed consent