cyrilzakka/clinical-trials huggingface dataset:
Efficacy of Silymarin in Patients With Non-alcoholic Fatty Liver Disease - The SILIVER Trial

Non-Alcoholic Fatty Liver Disease (NAFLD) is one of the most prevalent chronic liver diseases in Brazil and its treatment is still limited. Thus, this project aims to conduct a double-blind, controlled, randomized clinical trial to evaluate the effect of silymarin on laboratory markers and clinical evolution of adult patients with NAFLD treated at Edgard Santos Hospital, as well as identify the dietary pattern of these individuals.

Non-Alcoholic Fatty Liver Disease (NAFLD) is one of the most prevalent chronic liver diseases in Brazil. It has a significantly increasing incidence today and is considered an important global health problem. It affects approximately 20 to 30% of the adult population and increases according to the severity of the risk factors. The diagnosis of this disease usually occurs in 10 to 20% of the non-obese individuals, 50% in the overweight and 80 to 90% in the obese, being twice as present in individuals with Metabolic Syndrome. Pharmacological treatment options for NAFLD are still limited and Silybum marianum, one of the most sought-after herbal remedies in patients with liver disease, is commonly used by patients because of the claim of the hepatoprotective effect of silymarin. Studies have demonstrated the therapeutic potential of silymarin in patients with NAFLD, but clinical trials with more judicious methodological designs is still needed to prove these effects. Thus, this project aims to evaluate the efficacy of silymarin in adult patients with NAFLD seen at the Clinic of Nutrition and Hepatology of Edgard Santos Hospital. A randomized, double-blind, controlled clinical trial lasting 12 weeks will be performed.

Eligibility Criteria:
Inclusion Criteria:

* Adults between 20 and 60 years of age, both men and women,
* Clinical diagnosis of NAFLD, confirmed by imaging exams,

Exclusion Criteria:

* Women in the menacing period, with the exception of those who have performed definitive sterilization, such as hysterectomy or tubal ligation.
* Patients with established prior diagnosis of chronic noncommunicable disease (congestive heart failure, decompensated or severe lung disease, neoplasms, renal disease, advanced liver disease - Child Pugh C classification)
* Patients with schistosomiasis;
* Hemochromatosis
* Wilson's disease
* Viral or autoimmune hepatitis
* HIV virus carriers
* Woman who is breastfeeding
* Users of illicit drugs
* Patients with an intake of more than 20 g / day of alcohol and / or past alcoholism with abstention less than 6 months;
* Patients with ingestion of medications such as steroids, estrogens, amiodarone, warfarin, anti-convulsants, antipsychotics, tamoxifen or other chemotherapeutic agents in the last 6 months
* Patients with clinically manifest infections or inflammation, surgery, trauma or hospitalization in the last 30 days
* Chronic non-hepatic degenerative diseases (sclerosis, Parkinson's disease or Alzheimer's disease)
* Patients who do not participate in all stages of the research.
Individualized Telemedical Assistance for Lifestyle Modification in the Treatment of Obesity and Cardiometabolic Risk Prevention

This project is based on the contribution that could offer a technological system for a continuous monitoring, individualized treatment of obesity and prevention of cardiometabolic complications in high risk population.

The main objective of PREDIRCAM study is to evaluate the benefits obtained with the use in high cardiometabolic risk individuals of a telemedical platform integrating applications for monitoring and providing recommendations to improve lifestyle habits (diet and physical activity) in a healthier way.

The study population are obese subjects (type I or II) aged between 25 and 65 years with a 12 month follow-up. In this population it will be analysed the cost-effectiveness of a telemedic assistance with a technological system and its ability to modify lifestyle habits, reduce weight and cardiovascular risk associated parameters.

Previously to the clinical implementation, a pilot study for testing the telemedical system will be made. Efficacy and security variables will be evaluated along the study.


Eligibility Criteria:
Inclusion Criteria:

Preclinical Phase:

1. People over 18 years with or without obesity and with ability for technology management

Clinical Phase:

1. People between 18 and 65 years.
2. Obesity defined as a body mass index (BMI) greater than or equal to 30 kg/m2:

   1. Grade I or II without sleep apnea syndrome and ischemic heart disease
   2. Absence of metabolic processes (dyslipidemia) or associated hypertension requiring drug treatment at the time of inclusion in the study.
3. People with ability for technology management

Exclusion Criteria:

Preclinical Phase:

1. Serious illness and / or disabling

Clinical Phase:

1. Diabetes defining according to American Diabetes Association (ADA) criteria.
2. Subjects with moderate to severe active disease at the time of inclusion in the study protocol
3. Impaired glucose metabolism related diseases associated with diabetes mellitus or drugs interfering carbohydrate metabolism.
4. Cardiovascular disease
5. Dyslipidemia or hypertension requiring drug treatment.
6. Alcohol consumption
7. Pregnancy
8. Serious illness and / or disabling
Field Administration of Stroke Therapy - Magnesium (FAST-MAG) Trial

The goal of this study is to evaluate the effectiveness and safety of field-initiated magnesium sulfate in improving the long-term functional outcome of patients with acute stroke.

Stroke is the third leading cause of death and the leading cause of adult disability in the United States. Each year, more than 750,000 Americans suffer a symptomatic stroke.

Currently, tissue plasminogen activator (rt-PA) is the only approved treatment for acute ischemic stroke; however, its usefulness is limited because most patients cannot reach medical attention within the necessary 3-hour time window. In addition, rt-PA cannot be given in the field because it is contraindicated for treatment of patients with brain hemorrhage.

The purpose of this multi-center, randomized, double-blind trial is to demonstrate that paramedic initiation of the neuroprotective agent magnesium sulfate in the field is an effective and safe treatment for acute stroke. This study will analyze magnesium sulfate, an experimental therapy for stroke, versus placebo among ambulance-transported patients with acute stroke. This trial will also demonstrate that paramedics can safely, effectively, and rapidly start neuroprotective therapies for stroke.

Eligibility Criteria:
Inclusion Criteria:

* Suspected stroke identified by the Los Angeles Prehospital Stroke Screen
* Age 40-95, inclusive
* Last known well time within 2 hours of treatment initiation
* Deficit present for \>/= 15 minutes

Exclusion Criteria:

* Coma
* Rapidly improving neurologic deficit
* Pre-existing neurologic, psychiatric, or advanced systemic disease that would confound the neurological or functional outcome evaluations
* Systolic Blood Pressure (SBP) \< 90 or \> 220
* Known severe renal dysfunction (on dialysis or known chronic creatinine \> 3.0)
* Severe respiratory distress (O2 sat \< 90% or respiratory rate \< 12 or \>/= 24)
* Known second or third degree heart block with no pacemaker in place
* Major head trauma in the last 24 hours
* Recent stroke within prior 30 days
* Patient unable to give informed consent and no available on scene consent or assent provider
Increasing Ureagenesis in Inborn Errors of Metabolism With N-Carbamylglutamate

Hyperammonemia, which can cause brain damage, occurs in many different kinds of inborn errors of metabolism. The investigators propose to determine if short-term (3 day) treatment with N-carbamylglutamate can diminish hyperammonemia by enhancing ureagenesis in these patients. The investigators propose here a short-term (3 day) trial. If it succeeds, the investigators would consider more extensive long-term studies of the drug.

* To determine whether brief (3 day) treatment with N-carbamylglutamate can improve ureagenesis in adult healthy controls and patients with the following inborn errors of metabolism: N-acetylglutamate synthetase deficiency, propionic acidemia, methylmalonic acidemia, carbamylphosphate synthase deficiency, ornithine transcarbamylase deficiency and the syndrome of hyperammonemia, hypoglycemia and hyperinsulinemia (HHH Syndrome).
* To determine if such treatment improves other indicators of abnormal nitrogen metabolism such as elevated blood levels of glutamine, glycine and alanine.

Eligibility Criteria:
Inclusion Criteria:

* Age range: males or females, ages 3 years - 70 years
* Condition(s): N-acetylglutamate synthetase deficiency, propionic acidemia, methylmalonic acidemia, carbamylphosphate synthase deficiency, ornithine transcarbamylase deficiency and the syndrome of hyperammonemia, hypoglycemia and hyperinsulinemia.
* In addition, healthy volunteers will be studied (ages 18 years - 50 years).

Exclusion Criteria:

* Acutely ill on day of study (fever, evidence of hyperammonemia - ataxia, worsening obtundation, focal neurologic signs, seizures, increased intracranial pressure, vomiting, signs of acute respiratory or enteric illness, headache, confusion, disorientation, acute personality change).
* Girls 11 years of age must have a negative urine/serum pregnancy test within 1 week prior to testing unless having a menstrual period during week of test
* Lactating females
* Hyperammonemia probably refractory to N-carbamylglutamate: other urea cycle disorders (UCD), lysinuric protein intolerance, mitochondrial disorders, congenital lactic acidemia, fatty acid oxidation defects or primary liver disease.
* Amount of blood necessary for study exceeds safe limits.
* Any investigational drug use within 30 days prior to enrollment.
* Parents/guardians or subjects who, in the opinion of the PI, may be non-compliant with study schedules or procedures.
* Subjects who do not meet all the enrollment criteria may not be enrolled. Any violations of these criteria will be reported in accordance with Institutional Review Board (IRB) Policies and Procedures.
Augmenting Flortaucipir Dosimetry Estimates

This study will obtain data from urine in subjects administered flortaucipir in an Avid-sponsored study to augment the calculation of radiation dosimetry estimates.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who passed screening in an Avid-sponsored study in which flortaucipir will be administered

Exclusion Criteria:

* Subjects who have withdrawn informed consent
* Investigator or sponsor believes it is in the best interest of the subject to be removed from the trials
Quantification of the Pressure Threshold Related to Tissue Injury in Bedriden Paraplegics

The aim of this study is to correlate the intensity and the duration of a mechanical strain, applied over the skin of a bedridden paraplegics, with the microvascularization parameters (oxygen saturation, blood flow and blood volume) and the early inflammatory mechanism. We want to detect the early stage of irreversible damage for each patient. To achieve this goal, we measure some specifics data over a group of 48 paraplegics admitted in the hospital for a pressure ulcer surgical treatment. The patients are randomly distributed in 4 groups. First the interface pressure between the patient body and the air mattress is recorded continuously for 3 hours (= the repositioning patient frequency): we have the pressure over each point of the patient body in contact with the mattress on this time lap. Then, we will measure the microvascularization parameters, using an O2C medical device over a trochanter on a specific anatomical area which will be thereafter biopsied. Finally, depending on the group in which they were randomly distributed, the patient will undergo a muscle biopsy on his or her trochanter at 0h, 1h, 2h or 3h after they lie down on the air mattress. This way, we will be able to determine the effect of the mechanical strain duration on the physiologic parameters. The following day, the patient is undergoing his or her surgery for removing the necrotic area of the bedsore. At the same time, we will recover some of the sample near the bedsore which would serve as a maximum inflammatory response. Then a second muscle biopsy will be performed on an innervated area to be able to determine a basal concentration of biomarkers.

The inclusion period for this study will be 3 years. All the patients are followed for 24 hours then they will be followed by medical staff in their bedsore resection setting.

The data gained for this study will hopefully help the scientific world to achieve a better understanding of the pressure ulcer aetiology. They will also be helpful to achieve a mobilization of the patient specific of his or her inherent characteristics with a high sensitivity level. This way we will have a more efficient bedsore prevention.


Eligibility Criteria:
Inclusion Criteria:

* Educated consent signed,
* Older than 18,
* Paraplegia for at least 6 months,
* Patient's Body Mass Index \> 18,5kg/m²,
* Surgery planned for pressure ulcer resection,
* Pressure Ulcer classification (EPUAP) at least III or IV

Exclusion Criteria:

* Cardiac pathology,
* Duchenne muscular dystrophy,
* Dementia,
* Presence of a tumourous wound,
* Stade IV arteritis non-revascularisable,
* Diabetes mellitus,
* Cachexia,
* Impossibility to stop the anti-coagulant treatment 24 hours before the patient admission,
* Xylocaine allergy,
* Patient took aspirin or anti-inflammatory 3 days before the biopsy,
* Patient taking part in another study,
* Patient with no health insurance,
* Pregnant women or breast-feeding, patient unable to give his or her educated consent, ward of the state (art. L.1121-6, L.1121-7, L.1211-8, L.1211-9)
MyChart in Patients With Inflammatory Bowel Disease.

This study will be the first to assess the use of an electronic health records patient portal for patients with Inflammatory Bowel Disease. Patients with Inflammatory Bowel Disease (IBD), have reduced quality of life, high rates of depression and anxiety, do not receive routine preventative health maintenance (such as vaccines) at the same rate as the general public, and have low adherence to medications. The investigators are seeking to understand whether an electronic health record patient portal (EPIC's MyChart), can be utilized to improve quality of life in this patient population.

This study will be a single site randomized control trial.

Patients will be randomized into a control arm and intervention arm. At baseline the investigators will obtain demographic data, quality of life measures, and satisfaction with MyChart for those patients who are alrealy active portal users. The control arm will receive periodic messages through MyChart that are not specific to IBD. The intervention arm will receive more specific disease related information such as IBD educational information, reminders to take their medications, and reminders to get vaccinated. The intervention arm will also receive questionnaires that assess their mood (depression and anxiety). The investigators will then inform the primary gastroenterologist for those patients in whom mild, moderate or severe depression and anxiety is identified. At the end the study, in both groups investigators will measure quality of life as measured by the Short Inflammatory Bowel Disease Questionnaire (SIBDQ), a validated questionnaire for measuring health-related quality of life in patients with Crohn's and Ulcerative Colitis. Secondary outcomes will include: Satisfaction with Mychart as measured by a MyChart satisfaction survey, time to referral to mental health provider for patients identified with mild, moderate, or severe depression, or anxiety (PROMIS Depression and Anxiety Questionnaires), and Vaccine uptake (using a simple yes/no questionnaire asking patients if they received Flu, PCV13 or PPSV23.

The findings of this study will allow future clinicians to better understand how a patient portal can be utilized as a tool for the management of patients with IBD. This findings may lead to increased physician and patient engagement with the MyChart patient portal.

Eligibility Criteria:
Inclusion Criteria:

* Men and Women 18 years and older with a diagnosis of Inflammatory Bowel Disease (Crohn's or Ulcerative Colitis, or Indeterminate Colitis by standard criteria) who are scheduled for an upcoming appointment at the outpatient gastroenterology clinic or infusion unit.

Exclusion Criteria:

* Non-English speaking patients
* Patients identified by their physicians as being too cognitively impaired to participate
* Patients without access to computer with internet
* Patients not expected to be in the study area for the duration of the study such as patients only seen for a one time second opinion
A Phase 1 Study to Evaluate Safety, Tolerability and Pharmacokinetics of TIX100 in Healthy Subjects

A Single Center, Single Dose, Randomized, Placebo-controlled Study to Evaluate Safety, Tolerability and Pharmacokinetics of Orally Administered TIX100 in Healthy Subjects


Eligibility Criteria:
Inclusion Criteria:

1. Subjects aged 18-70 years, both genders.
2. Healthy as determined by a physician, based on history, medical examination, vital signs, laboratory tests, cardiac monitoring and respiratory function. History must comply with the following:

   1. Absence of clinically significant illness or surgery within the preceding 12 weeks.
   2. Absence of clinically significant history of neurological, endocrine, cardiovascular, pulmonary, hematological, immunologic, psychiatric, gastrointestinal, renal, hepatic, and/or metabolic disease.
3. Male subjects with female partners of childbearing potential must agree to utilize condoms for the duration of the study.
4. Female subjects of child-bearing potential with negative urine pregnancy tests and who agree to use double-barrier contraception during the study. The primary contraception may be either hormonal implant or hormonal or non-hormonal intrauterine device, and the secondary (barrier) method of contraception with condom and/or with spermicide.
5. Female subjects of non-child-bearing potential (i.e. tubal ligation, hysterectomy, or postmenopausal).
6. Body mass index (BMI) 18.5 - 29.9 kg/m2
7. HbA1c \<6.0%

Exclusion Criteria:

1. History of excessive alcohol use (defined as \>21 drinks per week for males and \>14 drinks per week for females), recreational drug use or drugs of abuse within the past three months, or failure on urinary drug screen.
2. Pregnant or breastfeeding within six months of screening assessment.
3. Substantial changes in eating habits or exercise routine within the preceding three months.
4. Evidence of eating disorders.
5. \>5% weight change in the past three months.
6. Bariatric surgery within the past five years.
7. Significant renal impairment (eGFR \<60 mg/mL/1.73m2).
8. Liver function tests (i.e., ALT, AST, alkaline phosphatase) greater than twice the upper limit of normal upon repeated measurements.
9. Diseases interfering with metabolism and/or ingestive behavior (e.g., myxedema, Cushing's disease, schizophrenia, major psychoses, unmanaged depression).
10. Use of drugs approved for the treatment of obesity.
11. Any clinically significant abnormality following the Investigator's review of the physical examination and clinical laboratory tests.
12. A baseline prolongation of QT/QTc interval after repeated measurements of \>450 ms; a history of unexplained syncope, cardiac arrest, unexplained cardiac arrhythmias or torsades de pointes, structural heart disease, or a family history of LQTS.
13. Participation in an investigational drug trial within three months prior to dosing in the present study.
Nutrition and Resistance Training in Head and Neck Cancer

To test the effects of nutrition versus nutrition with resistance exercise on muscle mass loss, fatigue and outcomes of concurrent chemo radiation.


Eligibility Criteria:
Inclusion Criteria:

* Stage 3 or 4 HNC

Exclusion Criteria:

* Previous Cancer
Efficacy and Safety Study of a Low-carbohydrate Tube Feed in Critically Ill Patients Under Insulin Therapy

The purpose of this study is to determine the efficacy and safety of a diabetes-specific tube feed in comparison to an isocaloric, isonitrogenous standard enteral formula in critically ill patients receiving insulin treatment for blood glucose management.


Eligibility Criteria:
Inclusion Criteria:

* Patients with spontaneous aneurysmal subarachnoid hemorrhage (SAH) defined according to Hunt and Hess scale grade HH5
* Requiring mechanical ventilation in the ICU at the time of enrolment
* Enteral nutrition (EN) in the ICU at time of enrolment

  * If enrolment on day 3 of ICU stay, EN equal to or larger than 80% of total calories in case of supplementary parenteral nutrition (PN) with anticipated 100% EN as of day 4 to 8 of ICU stay
  * If enrolment on day 4 of ICU stay, 100% EN planned for at least 5 days from the time of enrolment
* Patients expected to stay in the ICU for at least 5 days following enrolment
* Age 18 - 75 years
* Glycemic control with intravenous insulin therapy to maintain a target glucose range between 110 mg/dL and 150 mg/dL (6.1 and 8.3 mmol/l)
* Informed consent according to local regulations for decisionally impaired subjects

Exclusion Criteria:

* Patients with septic shock at time of enrolment
* Participation in a clinical trial with any investigational product within 4 weeks before study
* Patients requiring a fibre free diet
* Total or supplementary parenteral nutrition (\> 20% of total calories)
* Known or suspected intolerance or allergy to any component of the study product(s), e.g. galactosemia
* Gastrectomy
* Postpyloric nutrition
* Any clinical condition not allowing enteral nutrition (e.g. emesis, severe reflux, severe diarrhea)
* Known severe heart failure (NYHA class 4)
* Liver insufficiency / failure (male: ALAT \> 150 U/l; female: ALAT \> 120 U/l)
* Acute kidney failure (blood creatinine \> 2.5 mg/dl)
* Body Mass Index \< 18 or \> 35 kg/m²
* Known or suspicion of drug abuse
* Pregnant or breast feeding women
* Patients with diabetes mellitus type I

Exclusion After Enrolment (Withdrawal of Subjects)

* Start of PN with more than 20% of total given energy amount/ day
* Insulin infusion stopped unexpectedly for \> 12h for non-nutritional reasons
* Discharge from ICU
* Intolerable AEs
* Major protocol violation
* Withdrawal of informed consent
* Discontinuation of study treatment for other reasons
The Predictive Role of HPV Integration in HSIL and Cervical Cancer

The stratified analysis by the level of HPV DNA integration in HSIL and cervical cancer will be drawn to explore whether the status of HPV integration makes any difference in the progression of cervical cancer. The purpose of the research is to reduce the miss of cervix lesions and prove that HPV integration detection is sensitive in cervical cancer precise screening.


Eligibility Criteria:
Inclusion Criteria:

* HPV-positive patients； Patients have completed HPV detection, TCT, and HPV integration detection before surgery or biopsy； Patients with priced diagnoses accepted treatment according to ASCCP Risk-Based Management Consensus Guidelines for Abnormal Cervical Cancer Screening Tests and Cancer Precursors； Patients who are voluntary participants in this research and cooperate to follow-up with subscribing informed consent.

Exclusion Criteria:

* Patients who are not suitable for the trial； Patients existing other subtype malignancy tumors are still in treatment.
Study of Intracameral Adrenaline for Pupil Dilation Without Topical Mydriatics in Refractive Cataract Surgery

The purpose of this study is to study the safety and efficacy of intracameral adrenaline for pupil dilation without topical mydriatics in refractive cataract surgery.


Eligibility Criteria:
Inclusion Criteria:

* male and female
* can read and sign informed consent form；
* Clinical diagnosis of cataract
* Cataract density grade II-III according to the Emery-Little system classification system

Exclusion Criteria:

* sensitivity to adrenalin；
* sensitivity to topical mydriatics；
* any other ocular surgeries；
* iris abnormalities