cyrilzakka/clinical-trials huggingface dataset:
Pharmacokinetic Analysis of Nutrient Absorption From a Novel Liposomal Multivitamin/Mineral Formulation

This project is a randomized crossover trial examining the pharmacokinetic profiles of standard and liposomal multivitamin/mineral (MVM) formulations in healthy adults. Each participant will complete two research visits, which will be identical except for which MVM product is consumed. At each visit, participants will report to the laboratory after an overnight fast. After a baseline blood sample is collected, the MVM product will be consumed alongside a standardized breakfast. At 2-, 4-, and 6-hours post-ingestion, additional blood samples will be collected. Concentrations of representative minerals will be analyzed to determine whether differential nutrient absorption is observed with the liposomal MVM as compared to the standard MVM product. The results of this study will provide information about a novel liposomal MVM formulation and will inform future research and commercial applications of this technology.


Eligibility Criteria:
Inclusion Criteria:

1. age 18 to 65 at time of consent
2. ability to comply with study procedures
3. availability to complete study based on durations of individual visits and scheduling requirements
4. body mass of at least 110 pounds

Exclusion Criteria:

1. failure to meet any of the aforementioned inclusion criteria
2. presence of a disease or medical condition that could reasonably influence study outcomes or make participation inadvisable
3. use of medication that could reasonably influence study outcomes or make participation inadvisable
4. inability to abstain from medication, supplement, or substance use during the overnight fast and duration of the study visit
5. anticipated inability to provide blood samples (e.g., known difficulty providing blood samples)
6. currently pregnant or breastfeeding, based on self-report
7. allergy that would prevent safe consumption of standardized breakfast or multivitamin product
Postoperative Subtenons Anesthesia for Postoperative Pain in Pediatric Strabismus Surgery

The purpose of this study is to determine if local anesthetic, either a subtenons injection (an injection just beneath the surface tissue of the eye) or a topical ophthalmic gel (applied directly on the surface of the eye) given at the end of strabismus surgery reduces postoperative pain. Some surgeons routinely use either the subtenon and/or topical anesthetic for pain at the end of strabismus surgery.


Eligibility Criteria:
Inclusion Criteria:

* Age 1 year to \< 8 years
* Undergoing strabismus surgery under general anesthesia
* No previous surgery on muscle to be operated
* No known allergy to lidocaine or bupivacaine
* Investigator willing to inject subtenons NS or preservative-free bupivacaine 0.75% by cannula into all surgical wounds and willing to administer topical lidocaine 3.5% ophthalmic gel or Hypromellose 0.3% gel (GenTeal Severe Dry Eye Relief) to all surgical wounds at the end of strabismus surgery.
New Daily Persistent Headache Survey

Purpose: to explore headache characteristics and treatment effects of patient with new daily persistent headache (NDPH) through an online survey.

Research design: Online survey of patients with new daily persistent headache.

Risks: Risks include a breach of confidentiality as well as fatigue from taking the survey online.

Importance of knowledge that may recently be expected to result: The study aims to discover new information in a very understudied disease. This information could, in future studies, help change the diagnostic criteria or lead to new treatment options.


Eligibility Criteria:
Inclusion Criteria:

* Patients with NDPH that have been diagnosed by a health care professional (no documentation is needed, participant must simply state that he or she has been diagnosed)

Exclusion Criteria:

* Unable to speak English (the survey is only in English)
* Unable to use a computer to take the online survey
Posaconazole Pharmacokinetics in Patients Receiving Chemotherapy or Stem Cell Transplants

The purpose of the study is to investigate the pharmacokinetics of oral dosage of Posaconazole which is routinely administered as a standard care prophylaxis for patients undergoing cancer treatments.

Participants receiving Posaconazole prophylaxis for invasive fungal infection while undergoing cancer treatment will be required to sign an informed consent and donate blood samples for the study. Posaconazole is routinely administered as a prophylaxis using the oral tablet formulation (300mg once daily) as a standard care. Each prophylaxis course-duration will be defined according to local policy at each hospital. In general, Posaconazole prophylaxis commences prior to or with induction or consolidation chemotherapy in AML/MDS patients and continues until neutrophil recovery. In allo-HSCT setting, Posaconazole prophylaxis routinely commences on the day of transplant or with conditioning chemotherapy and continues for approximately 3 months after transplant, except in patients with initiation of intensive immunosuppression after diagnosis of acute or chronic GVHD, administration will go for at least 16 weeks or until prednisolone dose is less than 10mg per day, whichever is later. If patients are suspected or have proven malabsorption or are required to switch to an alternative antifungal agent such as in the case of suspected invasive fungal infection or Posaconazole toxicity, a switch to intravenous formulation of Posaconazole will take place.

Blood samples will be collected on Days 7, 14 and 21 from the onset of Posaconazole prophylactic treatment. If significant diarrhoea occurs, additional blood samples will be collected twice weekly until symptoms resolve, with the first sample being taken 3 days after the onset of diarrhoea. If gastrointestinal absorption is considered inadequate or invasive fungal infection is suspected and patients are switched either to IV antifungal prophylaxis or antifungal treatment as part of their standard care, a blood sample will be collected 20-24 hours after the last oral Posaconazole dose. Study participants will be followed up with respect to clinical data collection during the blood sample collection period and for up to 7 days after the last dose of Posaconazole for invasive fungal infection follow-up, and for the entire antifungal prescribing period (prophylaxis and/or treatment). Participants with diagnosed invasive fungal infection will be followed up to 30-days post-diagnosis with respect to clinical outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Adult (≥18 years old) haematology patients receiving Posaconazole prophylaxis in the inpatient setting as standard of care.
* Able to give informed consent.

Exclusion Criteria:

* Unable to give informed consent.
Effect of Exenatide on 24-Hour Blood Glucose Profile Compared With Placebo in Patients With Type 2 Diabetes

The purpose of this study is to test the hypothesis that in patients with type 2 diabetes, the addition of exenatide will result in lower time-averaged serum glucose during a 24-hour period, compared with placebo.


Eligibility Criteria:
Inclusion Criteria:

* Subject has an HbA1c between 7.0% and 10.0%, inclusive.
* Subject has a body mass index (BMI) \>25 kg/m\^2 and \<50 kg/m\^2.
* Subject is on a stable dose of metformin or metformin plus a thiazolidinedione.

Exclusion Criteria:

* Subject has been treated with any of the following medications: \*exogenous insulin for more than 1 week within 3 months of screening, \*sulfonylureas or meglitinides within 2 months of screening, \*alpha-glucosidase inhibitors within 2 months of screening, \*pramlintide acetate injection within 2 months of screening.
* Subject has received exenatide, GLP-1 analogs, DPP-IV inhibitors, or has participated in this study previously.
Effect of Pre-emptive Assessment of Self-care Peritoneal Dialysis (PD) Ability on PD Choice in Patients With Stage 5 Chronic Kidney Disease

Peritoneal dialysis is an effective renal replacement therapy with higher quality of life and lower treatment cost than hemodialysis.However, the application rate of peritoneal dialysis is much lower than that of hemodialysis. One of the reasons is that patients need to complete fluid changing operation independently, which is especially challenging for elderly and frail patients. Assisted peritoneal dialysis can help patients with independent dialysis disorders to complete dialysis. Currently, there is a lack of standard tools to assess patients' ability to conduct independent dialysis and to determine whether assisted dialysis is needed. Moreover, routine assessment is arranged after the training of dialysis operation, which leads to some patients giving up the procedure at an early stage, resulting in a low selection rate of the procedure.The purpose of this study was to investigate the effect of using a standard scale to evaluate the ability to perform abdominal dialysis in patients with stage 5 chronic kidney disease (CKD) before deciding on dialysis modality.


Eligibility Criteria:
Inclusion Criteria:

1. Age \>=18 years old;
2. Need dialysis within 6 months;
3. Informed consent.

Exclusion Criteria:

1. Absolute PD contraindications;
2. Need urgent dialysis;
3. RTX as initial renal replacement therapy.
Efficacy and Safety of Obeticholic Acid in the Treatment of Primary Biliary Cholangitis

Obecholic acid is a modified bile acid and Farnesoid X receptor (FXR) agonist. FXR is a key regulator of bile acid synthesis and transport. Bile acids are used by the body to help with digestion. Conventional therapy with obecholic acid will improve liver function of patients with (primary biliary cholangitis)PBC.

The main objectives of the study were to assess the effects of Obeticholic Acid (OCA) on serum alkaline phosphatase (ALP) and total bilirubin, together as a composite endpoint and on safety in participants with PBC.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 and ≤75 years；
2. Definite PBC diagnosis, as demonstrated by the presence of ≥ 2 of the following 3 diagnostic factors: ① Indicators reflecting cholestasis such as elevated ALP；② Positive antimitochondrial antibody (AMA) or AMA-M2, or positive PBC-specific antibody (anti-GP210 and/or anti-SP100) if AMA negative；③ Liver biopsy consistent with PBC；
3. At least 1 of the following qualifying biochemistry values: ① ALP ≥ 1.67x ULN ；② Total bilirubin \> ULN but \< 2x ULN；
4. Taking UDCA for at least 6 months (stable dose for ≥ 3 months) prior to Day 0, or unable to tolerate UDCA (no UDCA for ≥ 3 months) prior to Day 0；
5. Understand the study, comply with the study protocol, and voluntarily sign the informed consent form.

Exclusion Criteria:

1. Patients who took obeticholic acid within 3 months prior to Day 0;
2. Known hypersensitivity to obeticholic acid, ursodeoxycholic acid;
3. History or presence of other concomitant liver diseases;
4. Cirrhosis-related complications or end-stage liver disease manifestations;
5. Serum creatinine (Cr) ≥ 1.5 × ULN and serum creatinine clearance \< 60 mL/min;
6. Patients with severe pruritus or requiring systemic drug therapy within 2 months prior to Day 0;
7. Patients with HIV or syphilis infection;
8. Presence of diseases or physiological conditions that interfere with the absorption, distribution, metabolism or excretion of test drugs, such as inflammatory bowel disease and previous gastric bypass surgery;
9. Presence of diseases that may cause non-hepatogenic ALP elevation, or diseases that may lead to a life expectancy of less than 2 years;
10. Administration of the following drugs within 6 months prior to Day 0: azathioprine, colchicine, cyclosporine, methotrexate, mycophenolate mofetil, pentoxifylline; fenofibrate or other fibrates; budesonide and other systemic corticosteroids; hepatotoxic drugs (including α-methyldopa, sodium valproate, isoniazid, nitrofurantoin, etc.);
11. Administration of the following drugs within 12 months prior to Day 0: antibodies or immunotherapy against interleukins or other cytokines or chemokines;
12. Patients with serious cardiovascular system, digestive system, respiratory system, urinary system, nervous system, mental illness, immunodeficiency disease, and judge by investigators that they are not suitable for participating in the trial;
13. Other conditions that are not considered appropriate by the investigator.
Validation of a Rapid Quantitative Test for Loss of Smell in COVID-19 Subjects

The purpose of this study is to evaluate the performance of a non-invasive olfactory device as a rapid indicator of COVID-19 in positive subjects.

The major hypothesis is that a quantitative and unbiased smell test will be a useful tool to identify COVID-19 positive individuals.

The study will address what fraction of outpatients truly have a loss-of-smell (including a partial loss) and is expected to outperform the current question that is used to identify COVID-19 related anosmia "Do you have a new loss of smell or taste?" (yes/no) in terms of sensitivity and specificity.

The study will address if high-risk asymptomatic people whom are SARS-CoV-2 positive have a partial (or perhaps transitory) loss of smell.

The primary objective of this study is to validate the utility (sensitivity, specificity and accuracy) of a quantitative non-biased olfactory device for the rapid identification of SARS-CoV-2 infected subjects (as identified by PCR). The performance of the device will also be compared to the standard CDC patient query for 'new loss of smell or taste'.

The secondary objective is to test if SARS-CoV-2 positive 'asymptomatic' COVID-19 subjects may actually present with a mild or transitory defect in smell (hyposmia), which is revealed through our quantitative olfactory smell test.

Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated informed consent form
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Have a corresponding PCR test for SARS-CoV-2 on the same day.

Exclusion Criteria:

* Adults unable to consent
* Individuals who are not yet adults (infants, children, teenagers)
* Pregnant women
* Individuals with allergic to fragrances
* History of surgery on the nose or paranasal sinuses
* Asthmatics
* Patients with known neurocognitive disorders: dementia, Alzheimer's disease, Parkinson's disease
* Adults with Acute or Chronic rhinosinusitis (They will be asked if they have a 'stuffy or runny nose'; they may be included in some tests, but their analysis would be segregated as they may be false positives due to allergies or a common cold or flu)
Topical Preparation of Pomegranate and Ginkgo Biloba for Anti-aging Activities

As the quality of life improves, people are seeking to look as young as they feel. Ginkgo biloba (GB) and Pomegranate (PG) extract can be used to create efficacious topical anti-aging products. GB \& PG are now widely used in research and clinical trials on age-associated diseases, for example, skin aging, brain dysfunction, cardiovascular system diseases, carcinogen metabolism. The investigator's aim is to formulate a topical cream in the form (O/W or W/O emulsion) formulation, containing GB as an anti-aging formulation for the public.

In this study, a vanishing cream will be prepared by reaction of a stearic acid with alkali (NaOH) to form stearate soap. Then the GB extract will be added to the final form. The formulated cream will be characterized for identifying the type of emulsion, calibration curve for GB, drug content, irritation to skin, homogeneity test, pH, FT-IR test, ex vivo studies, physical stability, and human application. Finally, a 9-questions questionnaire was published using Google forms for the human volunteers.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of aging shape
* Follow up and collect data for a local and systemic activity of Ginkgo Biloba and Pomegranate
* The skin should be not injured as the cream can be easily applied
* Systemic oral capsule Ginkgo Biloba and Pomegranate can be also given to enhance the activity as anti-aging activity

Exclusion Criteria:

* Insulin-dependent diabetes
* Hypertension disease
* Skin wound
Waist Circumference in Cardiac Surgery

Metabolic syndrome including increased body mass index or waist circumference is known to be a risk factor of cardiovascular disease. However, the relationship between body mass index or waist circumference and clinical outcome after cardiac surgery has not been fully elucidated.

Along with body mass index, which is determined with height and weight, waist circumference reflects abdominal obesity and may increase cardio-metabolic risk and all-cause morbidity/mortality. In this observational study, we will review the electronic medical records of patients underwent cardiac surgery and assess their waist circumference, measured on preoperative computed tomography, as well as body mass index. The relationship between body mass index or waist circumference and mortality after cardiac surgery will be analysed.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing cardiac surgery between 2004 and 2016 at Seoul National University Hospital

Exclusion Criteria:

* Patients without information on height, weight, or waist circumference from abdominal computed tomography
Integrated Intervention Post-Sexual Assault

The primary objective of the proposed Stage IA/IB study is to establish feasibility of an integrated cognitive-behavioral intervention for reducing SUD and PTSD symptoms among women who experienced a sexual assault within the past six weeks. The intervention will be tested in an open label trial to make final modifications to evaluate feasibility, acceptability, and preliminary efficacy of the five to six week integrated intervention with standardized repeated measures during a one-month follow-up.


Eligibility Criteria:
Inclusion Criteria:

1. Female; any race or ethnicity; age 18 to 65 years old.
2. Sexual assault that occurred within the past ten weeks.
3. Subjects must be able to comprehend English.
4. Report a minimum of two substance use disorder symptoms
5. A minimum of one symptom of each cluster of Posttraumatic Stress Disorder
6. Subjects may also meet criteria for a mood disorder or other anxiety disorders (panic disorder, agoraphobia, social phobia, generalized anxiety disorder, or obsessive compulsive disorder). The inclusion of subjects with affective and other anxiety disorders is essential because of the marked frequency of the co-existence of mood and other anxiety disorders among patients with substance use disorder and posttraumatic stress disorder
7. Must consent to complete all treatment and follow-up visits.

Exclusion Criteria:

1. Lack of any memory of the sexual assault
2. Women who are menopausal
3. Subjects with a history of or current psychotic, manic, dissociative identify disorder, or a current eating disorder, as the study protocol may be therapeutically insufficient.
4. Subjects experiencing significant withdrawal symptoms, as evidence by a score of 10 or more on the Clinical Institute Withdrawal Assessment for Alcohol (CIWA)99 or a positive score of on the Clinical Opiate Withdrawal Scale.100 These subjects will be referred for clinical detoxification and may be re-assessed for study eligibility after medically supervised detoxification has been completed.
5. Individuals considered an immediate suicide risk, with current suicidal ideation and intent. These individuals will be referred directly for treatment.
6. Individuals on psychotropic medications must be stabilized on it for at least two weeks prior to beginning the study.
7. Any other medical or psychiatric conditions that the investigators believe may compromise the individual's ability to safely participate in the study.
Effects of GLP-1 on Chronic Heart Failure

The investigators planned to evaluate the effects of liraglutide on left ventricular function in chronic heart failure patients with type 2 diabetes.

Heart failure (HF) is a major cause of morbidity and mortality world wide. Glucagon-like peptide-1 (GLP-1) is an incretin hormone that regulates plasma glucose, and has direct effects on the cardiovascular system. In our previous study, the GLP-1 analogue liraglutide could improve left ventricular function in patients with acute myocardial infarction. However, the effects of GLP-1 on chronic heart failure patients with type 2 diabetes remain unclear. The aim of this study was to evaluate the effects of liraglutide on left ventricular function in chronic heart failure patients with type 2 diabetes.

Eligibility Criteria:
Inclusion Criteria:

* Chronic heart failure patients with type 2 diabetes (NYHA-class I, II or III) were eligible for the study

Exclusion Criteria:

* CHF (NYHA class IV)
* Type 1 diabetes
* Hospitalisation due to incompensated heart disease within 30 days prior to randomisation
* Myocardial infarction within the past 3 months before screening
* Coronary revascularisation within the past 3 months before screening
* Atrial fibrillation with ventricular frequency \>100/min in rest
* ECG suggestive of malignant ventricular arrhythmia
* Prolonged QT-interval (\>500 ms)
* Valvular heart disease
* Current myocardial or pericardial infection
* Obstructive hypertrophic cardiomyopathy
* Cancer unless in complete remission for ≥5 years
* Acute pancreatitis
* Compromised kidney function (eGFR \<30 mL/min), dialysis or kidney transplantation
* History of thyroidea adenoma or carcinoma
PipEracillin Tazobactam Versus MERoPENem for Treatment of Bloodstream Infections Caused by Cephalosporin-resistant Enterobacteriaceae (PETERPEN)

Data regarding optimal treatment for extended-spectrum beta-lactamase (ESBL) producing Enterobacteriaceae blood-stream infection are lacking. Observational studies show conflicting results when comparing treatment with combination beta-lactam-beta-lactamase inhibitor and carbapenems. The investigators aim to evaluate the effect of definitive treatment with meropenem vs. piperacillin-tazobactam on the outcome of patients with bacteremia due to cephalosporin-non-susceptible Enterobacteriaceae. The investigators hypothesize that piperacillin-tazobactam is non-inferior to meropenem.


Eligibility Criteria:
Inclusion Criteria:

1. Adults (age ≥ 18 years)
2. New onset BSI due to E. coli or Klebsiella spp. in one or more blood cultures associated with evidence of infection.
3. The microorganism will have to be non-susceptible to third generation cephalosporins (ceftriaxone and ceftazidime) and susceptible to both PTZ and meropenem (see microbiological methods).
4. Both community and hospital-acquired bacteremias will be included.
5. We will permit the inclusion of bacteremias due to E. coli or Klebsiella spp. with concomitant growth in blood of skin commensals considered as contaminants.

Exclusion Criteria:

1. More than 72 hr. elapsed since initial blood culture taken, regardless of the time covering antibiotics were started (up to 72 hrs.).
2. Polymicrobial bacteremia. Polymicrobial bacteremia will be defined as either growth of two or more different species of microorganisms in the same blood culture, or growth of different species in two or more separate blood cultures within the same episode.
3. Patients with prior bacteremia or infection that have not completed antimicrobial therapy for the previous infectious episode.
4. Patients with septic shock at the time of enrollment and randomization, defined as at least 2 measurements of systolic blood pressure \< 90 mmHg and/or use of vasopressors (dopamine\>15μg/kg/min, adrenalin\>0.1μg/kg/min, noradrenalin\>0.1μg/kg/min, vasopressin any dose) in the 12 hours prior to randomization. In the absence of the use of vasopressors, a systolic blood pressure \<90 would need to represent a deviation for the patient's known normal blood pressure.
5. BSI due to specific infections known at the time of randomization:

   1. Endocarditis / endovascular infections
   2. Osteomyelitis (not resected)
   3. Central nervous system infections
6. Allergy to any of the study drugs confirmed by history taken by the investigator
7. Previous enrollment in this trial
8. Concurrent participation in another interventional clinical trial
9. Imminent death (researcher's assessment of expected death within 48 hrs. of recruitment)