cyrilzakka/clinical-trials huggingface dataset:
Drug-drug Interaction Study of CTP-543 and Itraconazole in Healthy Adult Subjects

This is a Phase 1 open-label study of the effect of itraconazole on the pharmacokinetics of CTP-543 in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Non-smoker who has not used nicotine-containing products for at least 3 months prior to the first dosing and throughout the study
* Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2 at Screening
* Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs or ECGs
* If of reproductive age, willing and able to use a medically highly effective form of birth control 30 days prior to first dose, during the study and for 30 days following last dose of study medication.
* Understands the study procedures in the informed consent form, and be willing and able to comply with the protocol

Exclusion Criteria:

* History or presence of clinically significant medical or psychiatric condition or disease
* History of any illness that might confound the results of the study or poses an additional risk to the subject by their participation in the study
* History or presence of alcohol or drug abuse within the past 2 years prior to the first dosing
* Females who are nursing, pregnant, or planning to become pregnant while in the study, and for 30 days after last dose of study drug
* Positive results at Screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV)
* A positive test or history of incompletely treated or untreated tuberculosis
* Donation of \> 499 mL of blood or plasma within 56 days of Screening (during a clinical trial or at a blood bank donation) and for 30 days after last dose of study drug
Peripheral Artery Occlusive Diseases (PAOD) Study - Clinical Assessment

To assess the clinical efficacy and to simultaneously explore the underlying molecular mechanisms of the beneficial effects of flavanol-rich cocoa on vascular function diabetic patients with peripheral artery occlusive diseases (PAOD) of the lower extremities will be investigated.

50 Type 2 diabetics according to the criteria of the American Diabetes Association suffering from PAOD with a pain free walking distance less than 200 m will be enrolled. In a randomized controlled parallel group study the before established novel 5-level approach of vascular diagnostics will be realised. In order to test the hypothesis, whether cocoa rich in flavanols improves vascular function of diabetic PAOD subjects will regularly intake flavanol rich cocoa (group 1: 975 mg/d, n=50 versus group 2: 90 mg/d, n=50) over a period of two months. Clinical endpoints are the Ankle-Brachial-Index, measured by Doppler ultrasound and the pain-free walking distance determined by a treadmill ergometer. All parameters of vascular diagnostic (see 5-level approach above) will be determined before and two month after cocoa ingestion.

Eligibility Criteria:
Inclusion Criteria:

1. Diabetes mellitus type 2 defined by the criteria of the American Diabetes Association

   * Fasted plasma glucose greater than 126 mg/dL
   * Plasma glucose levels greater than 200 mg/dL 2 hours after OGT
   * Casual plasma glucose greater than 200 mg/dL combined with diabetic symptoms.
2. Endothelial dysfunction defined by FMD \<4%
3. No changes of medication for 2 months
4. Significant PAOD (level IIb, III)

Exclusion Criteria:

1. Ejection fraction \<30%
2. Malignoms
3. Terminal renal failure with hemodialysis
4. Relevant cardiac arrhythmias
5. Acute inflammation defined as CRP \>0,5 mg/dl
6. PAOD (level IV)
The Effects of EPA/DHA Supplementation on Cognitive Control in Children With ADHD

Forty children with and 40 children without Attention deficit Hyperactivity Disorder (ADHD) receive Docosahexaenoic Acid (DHA) and Eicosapentaenoic Acid (EPA) or placebo via a dietary intervention. Cognitive control functions are measured with functional Magnetic Resonance Imaging (MRI) before and after the intervention. Behavioural change is monitored with behavioural scales.


Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria for subjects with ADHD

1. 8-12 year old boys
2. Diagnostic and Statistical Manual 4th edition (DSM-IV (APA, 1994)) diagnosis of ADHD, according to Diagnostic Interview Schedule for Children (DISC)
3. Scores in the clinical range on the Child Behaviour Checklist (CBCL) and Teacher Rating Form(TRF)
4. Ability to speak and comprehend Dutch.
5. Used to daily consumption of margarine

Inclusion criteria for controls

1. 8-12 year old boys
2. No DSM-IV (APA, 1994) diagnosis, according to DISC interview
3. No scores in the clinical range on the Child Behaviour Checklist (CBCL) and Teacher Rating Form (TRF)
4. Ability to speak and comprehend Dutch. 5 Used to daily consumption of margarine

Exclusion Criteria:

1. mental retardation (IQ \< 70)
2. major illness of the cardiovascular, the endocrine, the pulmonary or the gastrointestinal system
3. presence of metal objects in or around the body (pacemaker, dental braces)
4. history of or present neurological disorder
5. regular use of n-3 or n-6 fatty acid dietary supplements, products fortified with EPA or DHA, a regular diet high in fatty fish (= 1 serving per week) or participation in intervention studies or (school-) health programs in the four months prior to study participation.
Study in Healthy Subjects to Compare Two Tablet Formulations of Memantine (Ebixa®) in Fasted and Fed Conditions

The purpose of this study is to investigate the release of memantine into the bloodstream of two different formulations: one formulation containing lactose and one without lactose.

The study consists of two cohorts: A1 and A2.

Subjects in Cohort A1 will be administered the investigational medicinal product (IMP) in a fasted state and subjects in Cohort A2 will be administered the IMP in a fed state.

Each subject will change cohort during study participation, so that dosing will be done over two periods: either first fed and then fasted, or first fasted and then fed. The two periods will be separated by a period of 28 days (+7 days) where no investigational medicinal product is given.

All subjects will be confined to the clinic from one day prior to dosing until Day 4 (72 hours post-dose) in each dosing period.

Eligibility Criteria:
Inclusion Criteria:

* Healthy men and women ≥18 years of age with a body mass index (BMI) ≥18.5 and ≤28 kg/m2.
* Women must be non-pregnant and non-lactating.

Exclusion Criteria:

- The subject has any concurrent disorder that may affect the particular target or absorption, distribution, or elimination of the IMP.

Other in- and exclusion criteria may apply
Effect of Locally Administered Morphine and Bupivicaine on Acute and Chronic Postmastectomy Pain

This study investigate the effect of addition morphine to locally instillation bupivacaine on developing chronic neuropathic pain acute postoperative pain after breast cancer surgery and on the probability of developing chronic neuropathic pain.

Breast cancer is one of the most common cancer diagnoses in women and a significant cause of mortality and morbidity worldwide.Surgical treatment indicated in most patients. Persistent pain and sensory disturbances following surgery is a significant clinical problem with an average prevalence of 20-23.9%. Post-mastectomy chronic pain syndrome (PMPS) is defined as pain of neuropathic character located in the area of surgery and/or the ipsilateral arm, present at least 4 days per week, and with an average intensity of at least 3 on a numeric rating scale from 0 to 10. The pathological mechanisms may be related to patient characteristics, surgical technique and adjuvant therapy. Although the genesis of pain is multi-factorial, sectioning of the intercostobrachial nerve (a cutaneous branch of T1-2) is the nerve lesion diagnosed most often.

Uncontrolled acute postoperative pain is defined as an important risk factor for the development of chronic pain. Local anesthetics have been investigated in cancer breast patients through many routes; paravertebral blocks, thoracic epidurals, wound infiltration, topical lidocaine patch, and the topical application of EMLA( Eutectic Mixture of Local Anesthetics) cream on operation site. Most of above studies suggested a better outcome in terms of reduced postoperative pain and improved patient satisfaction.

Opioids exert a local analgesic effect is based on several observations: • Nociceptive afferent nerve fibers contain peripheral opioid receptors which are silent except in the presence of local inflammation. • Morphine and its metabolites are largely undetectable systemically when applied topically to skin ulcers, suggesting the analgesic effect is local • Peripheral opioid injections for local analgesia, such as intra-articular morphine after knee surgery, have been found to be effective in several trials. An effective topical opioid analgesic that could be applied to inflamed or open skin lesions would be a useful option for some patients where other options for pain relief have been exhausted.

Eligibility Criteria:
Inclusion Criteria:

* female patients with cancer breast scheduled for modified radical mastectomy with axillary dissection

Exclusion Criteria:

* allergy to the study drugs
* significant cardiac, respiratory, renal or hepatic disease
* drug or alcohol abuse
* psychiatric illness that would interfere with perception and assessment of pain
Clinical Pharmacokinetic Study of Ceftazidime and Cefazolin

Peritoneal dialysis-related peritonitis is a common complication of peritoneal dialysis, which is the main cause of transfer from peritoneal dialysis to hemodialysis. Guidelines for International Society for peritoneal dialysis（ISPD）published in 2016 recommend that timely and adequate use of antibiotics is the most important part of treatment. Empiric treatment should be initiated as soon as possible after obtaining microbiological specimens，then adjust the antibiotics according to culture results and drug sensitivity of bacteria. Intraperitoneal antibiotic can ensure antibiotic concentrations at the local sites of the infection are maximized，however, in patients with renal failure, the investigators should pay attention to the nephrotoxicity caused by the reduction of renal excretion，being guided by Pharmacokinetic/ Pharmacodynamic Principle on antibiotic can develop dosing recommendations to optimize antibiotic efficacy and minimize toxicity. In this study, the investigators aim to detect the concentration of ceftazidime and cefazolin in CAPD patients，so as to analyze the pharmacokinetics parameters and evaluate the rationality of the treatment.

The dose of cefazolin and Ceftazidime co-administered were 20 mg /kg，they were given intraperitoneal twice daily in the first bag and the fourth bag for 5 days，and given 1g once daily in the fourth bag for 9 days. Total treatment duration was 2 weeks.

At least 1-mL serum and 5-mL dialysate samples were collected at 1, 2, 4, 6, 10, 14 days after complete instillation of the first dialysis bag containing antibiotic into the peritoneal cavity. The samples were then centrifuged at 3,000 rpm, all study samples were stored frozen (-80℃) within 1 hour after collection.

Eligibility Criteria:
Inclusion Criteria:

Maintained on continuous ambulatory PD (CAPD) for at least 1 month,all patients received 4 exchanges per day with dialysate volumes of 2 L per exchange.

1. The diagnostic criteria for CAPD-related peritonitis are as follows:

   The dialysate fluid appears cloudy and accord with the following peritonitis diagnostic criteria: (with the following two can be diagnosed) A. Clinical manifestations of peritoneics, such as abdominal pain and/or turbid flow of fluid from peritoneal dialysis; B. Perital dialysis discharge of liquid pathogen culture positive. C. The white blood cell count of perital dialysis outflow liquid were more than 0. 1 x 10 x 9/L, and the percentage of polymorphic nucleocells is more than 50% (peritoneal dialysis fluid remains in the abdominal cavity for at least 2 hours for more than 2 hours);
2. No urine (less than 100ml per 24h).
3. Age range form 15 years old to 70 years old, gender is not limited;
4. Understand and agree to this clinical trial study.

Exclusion Criteria:

1. With a clear history of cephalosporine drug allergy or hypersensitivity;
2. Received antibiotic treatment within 1 week prior to entering the study;
3. Pregnant and lactating women;
4. Sepsis;
5. Patients with celiac malignancy;
6. The patient is unable to cooperate or unwilling to accept the test.
A Study of Ketamine Infusions to Treat Clinically-depressed ICU Patients

The purpose of this research is to study the effects of intravenous ketamine infusions for the treatment of patients with depressive symptoms in intensive care unit (ICU).


Eligibility Criteria:
Inclusion Criteria:

* Has been in the Mayo Clinic Florida ICU for the past 1 week.
* PHQ-9 score of 10 or higher.
* One of the following diagnoses: acute myocardial infarction; acute renal failure; chronic obstructive pulmonary disease (COPD); congestive heart failure; end-stage liver disease; patients requiring intra-aortic balloon pump (IABP) therapy or continuous renal replacement therapy (CRRT); post-bone marrow transplant; acute Hypoxemic Respiratory Failure; acute or chronic hypoxemic respiratory failure; pre- or post- lung, liver or heart transplant or surgical overflows (such as abdominal aortic aneurysm, thoracotomy or tracheostomy).

Exclusion Criteria:

* Poor vital sign stability hypoxia: O2 \< 95%, hypotension: SBP \< 90 hypertension: SBP \> 180.
* Heart rate: \< 50 or \> 120, or Respiratory Rate: \< 10 or \> 30.
* Altered mental status.
* Patient is unwilling to participate or provide informed consent.
* Any allergy to ketamine or diphenhydramine.
* Patient is female of child-bearing age and unwilling to provide urine or blood for HCG analysis.
* Pregnant or breastfeeding.
* Presence of intracranial mass or vascular lesion.
* Presence of a history of psychosis or hallucinations (as assessed by electronic chart review).
* Weight greater than 115 kg or less than 45kg.
* History of increased intracranial pressure/hypertensive hydrocephalus or increased intraocular pressure.
* Patient is acutely psychotic.
* Provider feels that patient currently or likely will require chemical and/or physical restraints.
* History of prolonged QT-interval.
* Current treatment includes any medication known to affect the N-methyl-D-aspartate receptor system (e.g., lamotrigine, acamprosate, memantine, riluzole, or lithium).
* Patient in withdrawal from substance abuse or who have used hallucinogens (including cannabis) in the last month for any indication, as determined by the clinical interview and urine drug screening.
Changes in Myocardial Biomechanics and Early Short-term Doxycycline Therapy in Patients With Primary Anterior STEMI

The purpose of the study is to investigate the changes of myocardial biomechanics and efficacy of doxycycline in patients with primary anterior STEMI.

It is known that MMPs (matrix metalloproteinases) take part in myocardial remodeling, which lead to the adverse remodeling of left ventricular. Doxycycline inhibiting MMPs and it help to prevent collagen degradation and following LV (left ventricular) dilatation. Some experimental studies on rat models have suggested an anti-remodeling effect of doxycycline in myocardial infarction by means of decrease in activity of MMPs-2 and recovery of contractile function of myocardium. The clinical trial was performed at 2013 (D.Antoniucci), but it was a single study and confirmed theoretical and experimental background.

The study is randomized, opened, controlled. 45 patients with the first anterior STEMI will be enrolled. On admission all patients will receive reperfusion therapy during the first 24 h. Patients will be randomized by the open envelope method and after that some of the participants will be on doxycycline (100 mg b.i.d. for 7 days) in addition to routine medical therapy for STEMI, but other will be on routine medical therapy of STEMI. After that they will have echocardiography at 3-d, 7-th, 14-th days and 6 month after STEMI. The investigators will evaluate left ventricular function of these patients by routine and speckle-tracking echocardiography, incidence of cardiovascular end points (death, recurrent myocardial infarction, angina, heart failure, stroke) and their combinations, also the investigators will take blood samples to assess metalloproteinases (MMPs) and other biomarkers.

Eligibility Criteria:
Inclusion Criteria:

* age ≥ 18 and ≤ 75 years at time of randomization (18 years and older)
* ST-elevation Q wave myocardial infarction
* term admission to an intensive care unit (ICU) in the first 24 hours of onset
* the reperfusion of the infarct-related coronary artery is not later than 24 hours after the initial onset of acute transmural myocardial infarction
* written the informed consent to participate in research

Exclusion Criteria:

* atrial fibrillation, a permanent form
* valvular heart disease
* severe comorbidity
* acute heart failure according to the Killip classification IV FC (functional class)
* history of chronic heart failure (NYHA III-IV)
* poor image quality for Echocardiography
* sinus bradycardia - heart rate of under 50 beats per minute, interventricular conduction delay (QRS \> 0,11 s.) and atrioventricular block II-III degree
A Controlled Study of the Aqueous Humor Dynamics of AR-13324 Ophthalmic Solution in Healthy Adult Volunteers

To evaluate the effect of netarsudil (AR-13324) ophthalmic solution on aqueous humor dynamics relative to its placebo.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy adult male or female subjects at least 18 years of age.
2. Local area resident, existing patient or employee of Mayo Clinic.
3. Medically healthy subjects with clinically insignificant screening results.
4. Subjects with two normal (non-diseased) eyes.
5. Intraocular pressure between 14 and 21 mm Hg (inclusive) in each eye at screening.
6. Best-corrected visual acuity in each eye of +0.4 (20/50) or better.
7. Able and willing to give signed informed consent and follow study instructions.

Exclusion Criteria:

1. Chronic or acute ophthalmic disease including glaucoma, macular degeneration, uveitis clinically significant cataract.
2. Known hypersensitivity to any component of the formulation or to topical anesthetics.
3. Previous intraocular surgery, retina laser procedures or refractive surgery.
4. Myopia greater than -4.00 D spherical equivalent.
5. Hyperopia greater than +2.00 D spherical equivalent.
6. Ocular trauma within the past six months.
7. Evidence of ocular infection, inflammation, cystoid macular edema, clinically significant blepharitis or conjunctivitis, or a history of herpes simplex keratitis.
8. Ocular medication of any kind within 30 days of screening.
9. Any abnormality preventing reliable applanation tonometry of either eye.
10. Central corneal thickness less than 500 μm or greater than 600 μm.
11. Cannot demonstrate proper delivery of the eye drop.
12. Clinically significant systemic disease which might interfere with the study.
13. Participation in any investigational study within the past 30 days prior to screening.
14. Use of systemic medication that could have a substantial effect on intraocular pressure within 30 days prior to screening, or anticipated during the study.
15. Women of childbearing potential who are pregnant, nursing, planning a pregnancy, or not using a physician-supervised form of birth control for at least the last 2 months.
Effectiveness of Different Non-pharmacological Methods in Pain Management During Vaccination.

Aim: This study was conducted to determine and compare the effectiveness of different non-pharmacological methods in pain management during vaccination.

Methods: This randomized experimental study with placebo and control groups was conducted with 175 infants assigned to the ShotBlocker® (n = 35), ShotBlocker®-placebo (n = 35), sucrose (n = 35), sucrose-placebo (n = 35) and control (n = 35) groups. The pain levels of the infants were determined by blind assessors (nurses, parents, and observer) using the Neonatal Infant Pain Scale (NIPS) before and during vaccination.


Eligibility Criteria:
Inclusion Criteria:

* Born at full term
* No infection, redness, deteriorated skin integrity, or nerve damage in the area of application
* Had not undergone any clinical injection.

Exclusion Criteria:

* Infants who have applied analgesics before the vaccination
A Prospective Study on Predictive Value of Non-Invasive Atherosclerotic Measurements in Elderly Chinese

The purpose of this study is to determine whether non-invasive atherosclerotic measurements (baPWV, IMT, FMD, CACS, ABI) are valuable predictors for cardiovascular events in elderly. At inception, routine physical examination and non-invasive atherosclerotic measurements will conducted on all participants. Then they will be followed prospectively for at least 2 years. All cardiovascular and other health events will be recorded.

Cardiovascular disease is the most common cause of morbidity and mortality in the world, especially in elderly. Conventional risk factors are widely used in clinical practice, but it is inadequate and inaccurate due to no direct evaluation of artery. However, invasive method, it is difficult to be applied in atherosclerosis screening and only used in advanced institutions, is expensive and unacceptable. We are trying to assess the value of noninvasive measurements in predicting cardiovascular events.

Five invasive methods will be applied in the study, including

* brachial-ankle Pulse Wave Velocity(baPWV)
* Carotid Intimal-Medial Thickness(CIMT)
* Flow Mediated Dilation(FMD)
* Ankle-Brachial Index(ABI)
* Coronary Artery Calcification Score(CACS)

These indices represent not only different phase of atherosclerosis, but also various sections and arterial layers.

Eligibility Criteria:
Inclusion Criteria:

* Chinese, age\>=60, no gender restriction.
* To be able to apply the measurement mentioned above.
* Medical history are maintained precisely.
* Tianjin Medical University General Hospital is the participants' designated hospital by national health authority.

Exclusion Criteria:

* Systemic inflammation.
* Malignant tumor
* Chronic lung disease
* Liver disease
* Aortic aneurysm
European Real-World Registry for Use of the Ion Endoluminal System

The objective of this study is to collect collect real-world data for the Ion endoluminal system.

This is a prospective, observational, multi-center, single-arm study to collect real-world data evaluating procedural characteristics and short- and long-term clinical outcomes following the use of the CE-marked Ion endoluminal system for elective lung nodule biopsies and/or localization procedures. It is a post-market study using the device per the approved indications. All patients will be enrolled per the protocol eligibility criteria. Enrollment for this study will conclude when approximately 1,200 patients have had a nodule biopsy and/or localization procedure attempted or performed.

Eligibility Criteria:
Inclusion Criteria:

* Patient is aged 18 years or older at time of consent.
* Patient is planned to undergo a lung lesion biopsy(s) and/or localization procedure(s) utilizing the Ion endoluminal system.
* Patient is willing and able to give written informed consent for clinical study participation.

Exclusion Criteria:

* Patient is participating in an interventional research study or research study with investigational agents with an unknown safety profile that would interfere with participation in this study or study results.
* Female patient that is pregnant or breast feeding as determined by standard site practices.
* Patient is legally incapacitated or in a legal/court ordered institution or is part of a known vulnerable population, including but not limited to dependency on the sponsor, hospital or study doctor.
* Patient is not willing to comply with post-procedure study participation requirements.
* Investigator, in their professional opinion, has decided that it is in the patient's best interest to not participate in the clinical study.