cyrilzakka/clinical-trials huggingface dataset:
Effects of Dietary Antioxidants on Cardiovascular Risk Factors

The aim of the Antioxidant Study was to compare the efficacy of foods naturally rich in antioxidants with that of antioxidants in a pill form on markers of inflammation and plasma cholesterol in healthy adults at risk of cardiovascular disease.

Increasing the amount of antioxidants in your diet is thought to be one way to improve your health. If antioxidants do have a beneficial effect, one way to measure that is to examine possible changes in the levels of inflammatory markers in your blood.

Participants were asked to consume an antioxidant supplement including carotenoids, mixed tocopherols, vitamin C and selenium, or a placebo for 8 weeks. The doses of antioxidants will be similar to the amounts suggested by the United States Department of Agriculture (USDA) recommended daily allowances (RDA). In addition, a group of participants will be asked to change their usual eating habits and consume more of certain foods that are naturally good sources of the four antioxidants contained in the pills.

Eligible participants were asked to come to the Stanford Campus for 3 fasting blood draws over the period of 8 weeks and to complete diet and physical activity questionnaires at the beginning, middle, and end of the study period.

Eligibility Criteria:
Inclusion Criteria:Overweight/obesity; high LDL cholesterol, pre-hypertension.

Exclusion Criteria:1. Daily intake of \> 5 servings of vegetables and fruits 2. Fasting blood glucose \>140 mg/dL 3. BMI \>40 4. Liver or renal disease; Atherosclerosis (e.g., CAD, PAD); Malignant neoplasm; Ongoing infection; Inflammatory disease 5.Currently taking the following medications: Anti-inflammatory drugs Lipid lowering drugs Anti-hypertensive drugs Calcium containing drugs Drugs known to affect blood coagulation Drugs known to affect antioxidant status 6. Pregnant or lactating 7. Inability to communicate effectively with study staff
Phase 1 Study of GC1130A in Pediatric Patients with Sanfilippo Syndrome Type a (MPS IIIA)

The purpose of this study is to evaluate the safety, tolerability, efficacy, pharmacokinetics and pharmacodynamics of recombinant human heparan N-sulfatase (rhHNS, GC1130A) administered via intracerebroventricular access device in pediatric patients with Sanfilippo Syndrome Type A (MPS IIIA).


Eligibility Criteria:
Inclusion Criteria:

* Participants with documented MPS IIIA diagnosis
* Participants aged ≥ 24 months and ≤ 72 months

Exclusion Criteria:

* Participants with significant non-MPS IIIA related central nervous system impairment
* Participants with previous complication from intraventricular drug administration
* Participants with contraindications for MRI scans and for neurosurgery
* Participants that received treatment with any investigational drug or a device intended as a treatment for MPS IIIA within 30 days or 5 half-lives prior to the study
* Participants that received a hematopoietic stem cell or bone marrow transplant or received gene therapy
A Survey of Parent/Caregiver Practices on the Storage, Use, and Disposal of Opioids in a Comprehensive Cancer Center

This trial uses a survey to study parent and caregiver practices on the storage, use, and disposal of opioids in a comprehensive cancer center. It is not known if parents and/or caregivers are aware of the guidelines and recommendations for proper and safe disposal of opioids. This survey will help health care providers assess the needs and improve the safety of patients and their families from the potential dangers of misuse and abuse of prescription opioid medications.

PRIMARY OBJECTIVES:

I. To determine the frequency of unsafe storage, use, and disposal of unused and currently used opioids by parents and/or caregivers of patients 18 years and younger at MD Anderson Cancer Center.

II. To explore potential association between other covariates with the unsafe storage, use, and disposal of opioids.

OUTLINE:

Participants complete online survey on an iPad over 20 minutes.

Eligibility Criteria:
Inclusion Criteria:

* PARENTS/CAREGIVERS: Must be at least 18 years old (a. The child of the parents/caregivers must be 18 years old or younger; b. The child of the parents/caregivers must have received an opioid prescription within the last six months.)
* PARENTS/CAREGIVERS: Must be able to understand, read, write, and speak English.
* PARENTS/CAREGIVERS: Parent/caregiver must sign an informed consent.
Implementation of 23 Hour Surgery Model in a Tertiary Hospital

Extended day surgery or 23 h surgery (23-hour surgery) is a surgical model where patients arrive to the hospital from home at the day of surgery, are operated and recover in a 23 h surgery unit. 23H surgery units are usually situated near postoperative recovery unit. THe 23 H surgical model was implemented in Kuopio University Hospital 2015 and between May 2017-May 2018 patients were recruited in the present prospective follow up cohort study. Patients were informed and they gave their informed consent. The patients were contacted two weeks after the study and details of their recovery were asked.

Extended day surgery or 23 h surgery is a surgical model where patients arrive to the hospital from home at the day of surgery, are operated and recover in a 23 h surgery unit. 23H surgery units are usually situated near postoperative recovery unit. THe 23 H surgical model was implemented in Kuopio University Hospital 2015 and between May 2017-May 2018 patients were recruited in the present prospective follow up cohort study. Patients were informed and they gave their informed consent. The patients were contacted two weeks after the study and details of their recovery were asked. Satisfaction to the care in 23 h unit and surgical process, were asked. Amount of readmissions, reoperations, contacts to health care professionals and adverse events are recorded.

Detailed information about intensity of pain, analgesic need and use in the hospital was recorded and pain interference in daily life for short term recovery period was asked.

Eligibility Criteria:
Inclusion Criteria:

* adult
* gave informed consent

Exclusion Criteria:

* no informed consent
Characterization of Pain Processing Mechanisms in Irritable Bowel Syndrome

The purpose of this study is to provide new information and to determine which kinds of brief, tolerable, experimental pain are affected by the drugs being studied in patients with irritable bowel syndrome, a disease that causes chronic abdominal pain. The effects of dextromethorphan, naloxone, and fentanyl on experimental pain stimuli will be tested in these studies to better understand what causes irritable bowel syndrome.


Eligibility Criteria:
* Patients with irritable bowel syndrome and healthy pain-free individuals (as controls) will be studied.
* No medical condition that would contraindicate use of dextromethorphan, fentanyl or naloxone.
Tailored Videos to Reduce Tobacco Smoke Exposure Among Pregnant Women and Newborns

The purpose of this study is to develop and evaluate the efficacy of five tailored DVDs in reducing exposure to environmental tobacco smoke (ETS) among low income pregnant/postpartum women.

BACKGROUND:

The Healthy People 2010 Objectives address the importance of smoking cessation during pregnancy and the importance of reducing ETS exposure among children and adults. This study will use a new combination of existing technologies to maximize the appropriateness of prenatal and postpartum education concerning ETS exposure in an innovative, inexpensive, and widely applicable approach. The use of tailored DVDs is practical, feasible, and inexpensive enough to be attractive to clinics serving low-income and minority women. A large number of video segments will be produced utilizing live actors, animation, and word slates. About 10 segments will be computer-selected for the videos for each woman based on her responses to four self-assessments. No studies to date have included multiple doses of tailored video education, or used DVDs in this way.

DESIGN NARRATIVE:

This two-arm randomized study is designed to develop and evaluate the efficacy of five tailored DVDs in reducing exposure to ETS among low-income pregnant/postpartum women. The overall purposes of the study are 1) to develop an innovative intervention (tailored "take-home" DVDs) to help pregnant women maximize their pregnancy outcome and their new infant's health through reduction in exposure to ETS and 2) to study the feasibility and efficacy of this intervention compared with a usual care group. This innovative technology will be field tested in collaboration with six prenatal clinics that serve primarily low-income, African American, Latina, and minority women to address two specific aims. Specific aim 1: To test the efficacy of tailored video (TV) versus usual care (UC) approaches in terms of reducing the ETS exposure among fetuses of nonsmoking, low-income women during pregnancy (assessed at 34 weeks gestation using saliva cotinine concentration and ETS self-report) and among infants (as measured by saliva cotinine concentration and mothers' self-reports at 6 months postpartum). Specific aim 2: To test the efficacy of TV versus UC approaches in terms of reducing the exposure of the fetuses of low-income, smoking women to tobacco smoke during pregnancy (assessed at 34 weeks gestation using saliva cotinine concentrations of the pregnant women and smoking and ETS self-reports) and to their infants (as measured by saliva cotinine concentration from the infant at 6 months postpartum and self-reports of infant exposure by the new mothers). Because of the lack of data on reducing ETS exposure amongst low-income and minority women, intensive formative and extensive process evaluation components are included.

Eligibility Criteria:
Inclusion Criteria:

* Women who attend their first prenatal visit by 16 weeks gestation
* Women exposed to tobacco smoke daily

Exclusion Criteria:

* Women expecting complications or multiple births
Combination Treatment Using Capravirine (AG1549), Nelfinavir, and Two Nucleoside Reverse Transcriptase Inhibitors in HIV Patients Who Failed Initial Combination Therapy

The purpose of this study is to look at the effectiveness of an anti-HIV drug combination that adds capravirine in patients who have failed their first drug combination treatment.

\[Note: As of 2/28/2001, due to toxicity studies and concern for safety, changes in the methodology were implemented and patients need to sign new informed consents. The study is unblinded. Group 1 receives AG1549; Group 2 receives an AG1549 placebo. Patients who are taking capravirine and who currently have viral loads below 400 copies/ml may continue to take capravirine at 1400 mg twice daily. Capravirine will be discontinued in patients with viral loads greater than 400 copies/ml at their last visit and they will be switched to new therapies or continue with their background therapies as deemed appropriate by the investigators.\] Both groups also receive nelfinavir mesylate and 2 NRTIs. All patients receive the same dose of nelfinavir mesylate. The NRTIs are selected at the investigator's discretion provided the patient has not previously received the chosen NRTIs. Patients have regular physical examinations. Blood samples are collected regularly and at 1 month post-treatment to determine plasma HIV RNA, pharmacokinetics, and CD4 and CD8 counts. Patients who complete 24 weeks of treatment will have the option to continue treatment for an additional 24 weeks or end participation.

Eligibility Criteria:
Inclusion Criteria

Patients may be eligible for this trial if they:

* Are HIV-positive.
* Have a CD4 cell count more than 50/mm3.
* Are at least 18 years old.
* Have adequate blood, kidney, and liver functions.
* Are currently taking an anti-HIV drug combination of an NNRTI plus 1 or more NRTIs for more than 28 days and are failing that combination.

Exclusion Criteria

Patients will not be eligible for this trial if they:

* Have had any protease inhibitor or capravirine treatment.
* Have been given any drug that interferes with their immune system or with the study drugs within 28 days of study entry.
* Have had radiation therapy within 28 days of study entry.
Open Label Safety and Efficacy Study of Levetiracetam in Patients With Epilepsy

Community based study assessing safety and efficacy of levetiracetam in partial onset seizures.

The optimal dose in daily clinical practice will be used.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with epilepsy experiencing partial seizures, whether or not secondarily generalized.
* Subjects must present between 3 and 42 partial seizures over the three months prior to protocol Visit 1.
* Use of one (1), but no more than two (2) concomitant marketed antiepileptic drugs (AEDs) at the time of trial entry.

Exclusion Criteria:

* Subjects on vigabatrin, whose visual field has not been assessed as per recommendation of the manufacturer, i.e. every 6 months.
* Presence of known pseudoseizures within the last year.
* Presence of progressive cerebral disease, any other progressively degenerative neurological disease, or any cerebral tumors.
* Uncountable seizures (clusters) or history of convulsive status epilepticus within the last five years.
Pharmacokinetic and Pharmacodynamic Properties of BIOD-123 and BIOD-125 Compared to Humalog® in Subjects With Type 1 Diabetes Including Assessments of Injection Site Toleration

The primary objective is to assess the speed of absorption of BIOD-123 and BIOD-125 and compare them to Humalog.

The primary objective is to assess the speed of absorption of BIOD-123 and BIOD-125 and compare them to Humalog.

The secondary objectives are to assess other pharmacokinetic characteristics of BIOD-123 and BIOD-125 and compare those to Humalog®, to assess pharmacodynamic characteristics of BIOD-123 and BIOD-125 and compare those to Humalog®, and to evaluate the safety and tolerability of BIOD-123 and BIOD-125 compared to Humalog®

Eligibility Criteria:
Inclusion Criteria:

1. Age: ≥18 - ≤70 years
2. BMI: ≥18 - ≤30 kg/m2
3. Diagnosed with type 1 diabetes mellitus for at least 1 year
4. Insulin antibody ≤10 μU/mL at screening

Exclusion Criteria:

1. Type 2 diabetes mellitus
2. History of \>2 severe hypoglycemic events within the 3 months prior to screening
3. Serum C-peptide \>1.0 ng/mL
4. Hemoglobin A1c (HbA1c) \>10.0%
5. Females who were breast feeding, pregnant, or intending to become pregnant during the study
6. A sexually active person who was not using adequate contraceptive methods
7. Positive serology for human immunodeficiency virus (HIV), Hepatitis B, or Hepatitis C
8. Abnormal ECG, safety lab, or physical examination results that were deemed clinically significant by the investigator
Study Investigating the Effect of Lu AF35700 on Cardiac Repolarization in Men and Women With Schizophrenia and Schizoaffective Disorder

The purpose of this study is to investigate the effect of Lu AF35700 on electrical activity in the heart as measured on an electrocardiogram (ECG) in patients with schizophrenia or schizoaffective disorder after 6 weeks of treatment


Eligibility Criteria:
Inclusion Criteria:

* The patient is able by her/himself to provide informed consent to participate in the study
* The patient has a primary diagnosis of schizophrenia or schizoaffective disorder (DSM-5™ criteria)
* The patient has BMI ≤35 kg/m2
* The patient has a Clinical Global Impression - Severity of Illness (CGI-S) score ≤4 (moderately ill)
* PANSS total score ≤ 80 and a score ≤4 (moderate) on the PANSS items, P7 (hostility) and G8 (uncooperativeness)
* The patient is willing to be hospitalized for up to 8 weeks
* The patient is generally healthy based on medical history, physical examination, vital signs, ECG, and laboratory tests.
* The patient agrees to protocol-defined use of effective contraception

Exclusion Criteria:´

* The patient experienced acute exacerbation of psychosis requiring hospitalization within the last 3 months or required change in medication due to exacerbation of psychosis within the last 8 weeks
* The patient has met moderate or severe co-morbid Substance Abuse Disorder DSM-5™ criteria in the last 3 months
* The patient is at significant risk of harming her/himself or others in the opinion of the investigator or according to Columbia Suicide Severity Rating Scale (C-SSRS)
* The patient has tested positive for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus antibody (anti-HCV)

Other protocol defined inclusion and exclusion criteria may apply
Pharmacokinetics of AGO178 in Participants With Liver Impairment

AGO178 was developed for the treatment of depression. A new formulation is being tested in the present study: a tablet to be placed and dissolved under the tongue (sublingual tablet). The goal of this trial was to study the pharmacokinetics of agomelatine given as sublingual tablet in participants with liver impairment and to compare the results to those of healthy volunteers who receive the same treatment.


Eligibility Criteria:
Inclusion Criteria:

* Participants with liver disease confirmed within 3 months of screening.
* If liver impairment is caused by alcohol use, participants must have abstained from alcohol use within 3 months of study start.
* Participants must satisfy criteria for Child- Pugh Class A or B.

Exclusion Criteria:

* Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer.
* Pregnant or nursing (lactating) women.
* Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless using effective contraception during the study.
* Donation or loss of 400 millilitres (mL) or more of blood within eight (8) weeks prior to initial dosing.
* Significant illness within the two weeks prior to the dosing.
* Participants with Child-Pugh alterations due to a non-liver disease (e.g. cancer or treatment related weight loss).

Other protocol-defined inclusion/exclusion criteria may apply.
Evaluation the Clinical Value of Xiyanping Injection in the Treatment of Community-acquired Pneumonia in Children

In order to verify the clinical value and safety of Xiyanping injection in children with CAP, we intend to carry out this multi-center, large-sample, non-intervention clinical research through more rigorous and scientific design. Considering the current status of clinical research in children in China,research use real-world research methods.

This is an real world study of efficacy and safety of intravenous injection of Xiyanping injection in pediatric subjects with CAP.The purpose to determine the clinical value and influencing factors of Xiyanping injection in the treatment of community-acquired pneumonia in children based on real-world clinical data. The starting point for the study was the time at which the patient started treatment with Xiyanping injection or using a conventional treatment regimen; the end of follow-up was the date of the last visit to the patient, and if the patient had a disease progression or transfer, the date of the occurrence was the end. At the same time, baseline demographic characteristics (gender, date of birth, type of medical insurance, etc.), therapeutic drugs during the follow-up period, dose and time of use, laboratory indicators (such as white blood cells, C-reactive protein, etc., and examination time) were collected.

Eligibility Criteria:
Inclusion criteria:

* 2 years old \< age ≤ 14 years old children, male or female, diagnosed as community-acquired pneumonia diagnosed and need hospitalization

Exclusion criteria:

* Acute infectious diseases such as measles, whooping cough, and influenza
* Other concomitant diseases or conditions that the investigators believe may interfere with the study, such as severe primary disease with severe heart, liver, kidney, digestive, and hematopoietic systems
* Children with severe malnutrition and previous history of immunodeficiency may seriously affect the self-limiting course of the disease
* Children with epilepsy and other central nervous system dysfunction
* Congenital diseases, mental patients
* Those who have used systemic hormones within 2 weeks before enrollment;
* Those who have used Qingrejiedu Chinese medicine within 2 weeks before enrollment
* The subject is poorly compliant (not according to the doctor's prescription or medical advice) or fails to timely feedback information
Brain Energy and Aging With Triheptanoin

BEAT7-001 is a single group study (supplementation). Using a multi-modal brain imaging portfolio, this study will assess whether brain energy metabolism (glucose and ketones), structure or functional connectivity change in older people with frontal glucose hypometabolism after 28 days on an oral dose of 1 g/kg/day of triheptanoin.


Eligibility Criteria:
Inclusion Criteria:

* Men and women ≥65 years old;
* Score ≥26/30 on the Montreal Cognitive Assessment; -≥10% lower brain glucose uptake in the frontal cortex as determined by PET imaging.

Exclusion Criteria:

* Score \<26/30 on the Montreal Cognitive Assessment;
* Medications likely to affect the primary cognitive outcome;
* Medical or psychiatric conditions that could interfere with study participation (Peterson et al. 2005);
* Fasting plasma glucose ≥7.0 mM (to avoid recruiting diabetics or pre-diabetics, both of which are risk factors for cognitive impairment in older persons (Mortimer et al. 2010) and also inhibit ketogenesis (Fukao et al. 2004);
* Clinically-significant gastro-intestinal disease/conditions;
* Clinically-significant liver disease/dysfunction : ALT ≥37 UI/L, AST ≥36 UI/L, Total bilirubin ≥26 μmol/L;
* Clinically-significant renal disease/dysfunction : creatinine ≥92 μmol/L, glomerular filtration rate \<60 ml/min/1.73 m2 or \>90 ml/min/1.73 m2;
* Clinically-significant cardiac disease/conditions;
* Clinically-significant abnormal coagulation laboratory results or coagulation disorders at screening;
* Poorly controlled dyslipidemia (total cholesterol ≥6.2 mmol/L or triglycerides ≥2.20 mmol/L)
* Hypertension: ≥140/90 mmHg;
* Substance abuse;
* Already on MCT supplementation;
* Visual or hearing impairment impeding comprehension;
* Non-French speaking;
* Any condition with life expectancy less than 5 years;
* Institutionalized or intending to move out of area within 1 year;
* Participation in other intervention trials.