cyrilzakka/clinical-trials huggingface dataset:
Pharmacokinetic Characterization of Intramuscular Olanzapine Depot

The goals of this study are to:

Determine the blood levels of intramuscular (IM) olanzapine depot in patients at different points in time after an injection, and compare these levels to the amount of olanzapine in the blood of patients after treated by oral administration with Zyprexa (olanzapine) tablets or by intramuscular administration with Zyprexa IntraMuscular (olanzapine for injection).


Eligibility Criteria:
Inclusion Criteria:

* Patients must have schizophrenia or schizoaffective disorders.
* Each patient must have a level of understanding sufficient to complete all tests and examinations required by the protocol, and to provide informed consent.
* Patient must not have participated in a clinical trial of another investigational drug, including olanzapine, within 1 month (30 days) prior to study entry.
* Female patients must not be pregnant or breast-feeding.
* Patients must not be experiencing acute, serious, or unstable medical conditions other than schizophrenia or schizoaffective disorder.
Efficacy of Plaque Removal of a Novel Brushing Device

The purpose of this research study is to compare how a novel, automated mouthpiece-based toothbrushing device removes dental plaque compared to a manual toothbrush.

Plaque is one of the main etiological factors in dental decay and the principal etiological factor for periodontal diseases. Although toothbrushes have greatly evolved, dexterity is still the key component to an efficient cleaning routine. The primary goal is to examine 60 participants to determine the efficacy of a new powered teeth cleaning device designed to bypass the variability of individual dexterity compared with manual toothbrushing.

This is a single-blind, randomized controlled trial. Sixty pediatric patients will be recruited for the study and randomized into treatment and control groups, subdivided into primary (20), mixed (20), and permanent dentition (20). Participants will be asked to abstain from brushing, flossing, gum or mouthwash use for 24 hours prior to the study visit. Plaque will be assessed using the Turesky Modification of the Quigley-Hein Plaque Index before and after a one-time brushing with the assigned study device. A soft tissue assessment will be conducted and intraoral photos taken pre- and post-brushing.

Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 5-17
* In good general health
* Fluent in English
* Parent or guardian willing and able to provide written informed consent
* Have 16 scorable teeth (non-crown/bridge/or full amalgams)
* Have had a dental cleaning and exam in the past 24 months

Exclusion Criteria:

* Advanced periodontal disease or severe gum disease
* Mouth or teeth pain that prevents brushing in any areas
* Intraoral piercings (tongue or lip) that cannot be removed
* Non-controlled diabetes
* Any autoimmune or infectious disease or any medical condition that would delay wound healing
* Untreated visible cavities or untreated dental work
* Oral or gum surgery in the previous 2 months
* Take antibiotic premedication for dental procedures
* Undergoing or require extensive dental or orthodontic treatment
* Current smoker
* Generalized recession over 1mm
Comparison of Lens Care Regimens With a Silicone Hydrogel Lens (Emerald)

The purpose of the study is to evaluate and compare, on a daily wear basis, the performance of two contact lens care solutions when used with silicone hydrogel soft contact lenses with regards to comfort and dryness symptoms.

The purpose of the study is to evaluate and compare, on a daily wear basis, the performance of two contact lens care solutions when used with silicone hydrogel soft contact lenses with regards to comfort and dryness symptoms by observing changes within the cornea and collecting subjective ratings

Eligibility Criteria:
Inclusion Criteria:

A person is eligible for inclusion in the study if he/she:

1. Is at least 17 years of age and has full legal capacity to volunteer.
2. Has read, understood and signed an information consent letter.
3. Is willing and able to follow instructions and maintain the appointment schedule.
4. Is presently using either bi-weekly or monthly replacement lenses.
5. Has symptoms of ocular dryness as determined by specific pre-screening criteria.
6. Is correctable to a visual acuity of 6/9 or better (in each eye) with their habitual vision correction.
7. Has clear corneas and no active ocular disease.
8. Has had an ocular examination in the last two years.

Exclusion Criteria:

A person will be excluded from the study if he/she:

1. Is an asymptomatic lens wearer.
2. Is a daily disposable contact lens wearer.
3. Is a current extended wear contact lens wearer.
4. Currently uses one of the study lens care regimens.
5. Has any clinically significant blepharitis.
6. Has undergone corneal refractive surgery.
7. Is aphakic.
8. Has any active ocular disease.
9. Has any systemic disease affecting ocular health.
10. Is using any systemic or topical medications that may affect ocular health.
11. Has known sensitivity to the diagnostic pharmaceuticals to be used in the study.
12. Is participating in any other type of clinical or research study.
Infant Feeding Practices in Transition: Breast Milk Intake, Complementary Feeding and Body Composition During Infancy

Research Aim: We assessed human milk intakes of Thai infants during the first 6 months comparing exclusive (EBF), predominant (PBF) and partial (PartBF) breastfeeding.

Methods: One-hundred and ten apparently healthy Thai lactating mother-infant pairs were followed from birth. Human milk intakes were determined at 6 weeks, 3 and 6 months, using the DTM method. Daily energy and protein intakes were assessed using 3-day non-consecutive 24-hour recalls. Socio-demographic characteristics were collected using a questionnaire. For comparisons among breastfeeding practices, one-way ANOVA with Tukey's post hoc test was used for normally distributed data, or Kruskal-Wallis Test with Mann-Whitney U Test for not normally distributed data.

Human milk intakes were comparable between the EBF and PBF infants during the first 6 months, and provided the sole source of energy and protein; infant formula largely replaced breast milk among PartBF infants.

Eligibility Criteria:
Inclusion Criteria:

* Apparently healthy women aged 20-35 year
* Had pre-pregnancy BMI in the normal range (18.5-25 kg/m2)
* Planned to breastfeed their baby for at least 6 months
* Being full term infants (gestational age 37-42 weeks) and singleton
* Had normal birth weight (2,500 - 4,000 g)
* Signed written informed consent to participate in the study

Exclusion Criteria:

* Infant: preterm; twin; low and high birth weight; congenital diseases
* Mother: chronic diseases needed to get medicine and treatment; underweight and obesity
* Mother and baby did not stay together throughout 12 months of infant age
Analysis of Lymph Node Metastasis and Tumor Deposit in the Short Gastric Mesentery Following Total Gastrectomy for Gastric Cancer

This study aims to explore lymph node metastasis in the short gastric mesentery following total gastrectomy with D2 lymphadenectomy plus complete mesogastric excision, providing evidence-based medicine for standardizing lymph node dissection in gastric cancer.

According to the 6th edition of the Japanese Gastric Cancer Treatment Guidelines; total gastrectomy with D2 lymphadenectomy includes groups No.1 to No.7, No.8a, No.9, No.11p, No.11d, and No.12a. The No.4sa group lymph nodes are defined as the lymph nodes along the short gastric vessel, No.10 group lymph nodes are defined as the lymph nodes at the splenic hilum including the lymph nodes at the roots of the short gastric arteries. In routine total gastrectomy with D2 combined with CME surgery, the standard practice involves resection of the short gastric mesentery (No.4sa group and No. 10 group). There are typically 3-4 short gastric arteries in the human body, further investigation is required to determine the lymph node metastasis rates in each short gastric mesentery. Patients undergoing total gastrectomy with D2 combined with CME will have their short gastric mesenteries anatomically separated for examination, and this aims to analyze the positive rate of lymph nodes in the short gastric mesentery and investigate the correlation between tumor location, staging, and lymph node metastasis in the short gastric mesentery.

Eligibility Criteria:
Inclusion Criteria:

1. Aged older than 18 years and younger than 85 years
2. Primary gastric adenocarcinoma confirmed by preoperative pathology result
3. cT2-4aN0-3M0 at preoperative evaluation according to the American Joint 8 Committee on Cancer (AJCC) Cancer Staging Manual 8th Edition
4. Patients who received total gastrectomy with D2 lymphadenectomy plus complete mesogastric excision
5. American Society of Anesthesiologists (ASA) class I, II, or III
6. Written informed consent

Exclusion Criteria:

1. Negative preoperative biopsy
2. Too late tumour stage or metastasis (cT4b/M1)
3. BMI\>30 kg/m2
4. previous neoadjuvant chemotherapy or radiotherapy
5. Previous upper abdominal surgery
6. Combined with other malignant diseases
7. Reject operation
Phosphate Bioavailability Hormonal Response to a Breakfast Meal in Healthy Humans

Convenience food is enhanced with phosphate additives in order to modify taste and texture and for preservation. The purpose of this study is to measure the response of phosphate-related hormones to two different types of breakfast meals that contain the same amount of phosphate but in different forms. This study is a cross-over design.

In the first meal, the participant will consume a standard convenience breakfast meal comprised of a cheese tea biscuit and two Eggo waffles. The amount of phosphorus contained in this meal is 700 mg and the majority of this phosphate would be in the form of phosphate additives. Urine and blood will be collected before and after consumption of the meal to measure how the body responds to the meal. Specifically, levels of phosphate, calcium, creatinine (measure of kidney function) and three hormones involved in phosphate regulation (parathyroid hormone, fibroblast growth factor-23 and vitamin D) will be measured in each blood sample. Creatinine, calcium and phosphate will be measured in each urine sample. The second meal will also contain 700 mg of phosphorus and similar caloric content but in a healthy breakfast meal that does not contain any phosphate additives, consisting of one cup of All-Bran breakfast cereal with milk and a piece of fruit. The same blood and urine tests will be assessed after the second meal.

Eligibility Criteria:
Inclusion Criteria

* healthy

Exclusion Criteria:

* kidney disease
Cardiorenal Interactions During Treatment of Acute Decompensated Heart Failure: Diuretics Versus Ultrafiltration

The CRUF trial is a prospective randomized monocentric trial comparing different impact of diuretics versus ultrafiltration on renal congestion, plasma refill rate, echocardiographic filling pressures, neurohormonal activation and biomarkers of Acute Kidney Injury (AKI).


Eligibility Criteria:
Inclusion Criteria:

* \>18 years old
* Severe systolic heart failure with ejection fraction \<40%
* And Hospitalisation for decompensated heart failure
* And New York Heart Association (NYHA) III or IV
* And 1 of the following:

  * Jugular vein distension\>6cm
  * Tissue Doppler mitral annulus lateral\>12 or medial\>15
  * Chest X-ray: pulmonary edema or pleural effusion

Exclusion Criteria:

* Need for inotropic or vasopressive agents
* Use of intravenous (IV) contrast media
* Acute coronary syndrome
* Need of dialysis
* Severe co-morbidity
* Contra-indications for anticoagulation
* Pregnancy
Cholesterol and CYP3A4/5 Metabolism Across Pregnancy and Postpartum

This study addresses the second aim of the grant (R01 HD0899455), which is to determine temporal changes in CYP3A4-mediated drug metabolism sequentially across pregnancy and after birth.

This study addresses the second aim of the grant (R01 HD0899455), which is to determine temporal changes in CYP3A4-mediated drug metabolism sequentially across pregnancy and after birth.

In studies with human hepatocytes, we found that serum from women in the first trimester led to the highest CYP3A4 expression compared to those from the second or third trimester or after birth. Among the hormones with elevated plasma concentrations in early pregnancy, our studies revealed that thyroid hormone enhances CYP3A4 expression in human hepatocytes. Based on the results, we hypothesized that CYP3A4-mediated drug metabolism is highest during early pregnancy (compared to the later time points of pregnancy or postpartum period) in part due to changes in thyroid hormone concentration.

To test this hypothesis, we will evaluate the conversion of endogenous cholesterol to its 4β-hydroxycholesterol metabolite, which is facilitated by CYP3A4. To assess additional factors that affect CYP3A activity, we will obtain DNA. About 75% of African Americans, but only 10-20% of people of European descent, carry the active allele CYP3A5\*1, which significantly increases the clearance of many CYP3A4/5 substrates, including the conversion of cholesterol to 4β-hydroxycholesterol.

Eligibility Criteria:
Inclusion Criteria:

* English speaking
* Pregnant before 14w0d OR postpartum between before 18w0d
* Singleton gestation (as this will result in more consistent inter-individual measures)

Exclusion Criteria:

* Chronic use of compounds that are substrates or inhibitors of CYP3A4 inhibitors, which will interfere with the concentrations and ratio. Potent inhibitors include clarithromycin, erythromycin, diltiazem, itraconazole, ketoconazole, ritonavir, verapamil, goldenseal and grapefruit. Inducers of CYP3A4 include phenobarbital, phenytoin, rifampicin, St. John's Wort and glucocorticoids.
* Diagnosis of alcoholism or substance use.
* Covid infection or within 4 weeks of positive test due to possible effect on hepatic function
D-Dimer Determined Anticoagulation INTENSITY in Patients With Mechanical Valve Replacement

The optimal intensity of oral anticoagulation in China patients undergoing mechanical valve replacements is still controversial due to the different risk profiles of thrombophilia and bleeding in Chinese patients. Elevated D-dimer could reflect a pro-thrombogenic or prothrombotic state, and thus might be used to decide the intensity of oral anticoagulation.

This study was to evaluate whether elevated D-dimer levels could help to determine the intensity of oral anticoagulation in patients with mechanical heart valve prostheses.

Background: The optimal intensity of oral anticoagulation in China patients undergoing mechanical valve replacements is still controversial due to the different risk profiles of thrombophilia and bleeding in Chinese patients. Elevated D-dimer could reflect a pro-thrombogenic or prothrombotic state, and thus might be used to decide the intensity of oral anticoagulation.

Objective: This study was to evaluate whether elevated D-dimer levels could help to determine the intensity of oral anticoagulation in patients with mechanical heart valve prostheses.

Methods: A single-center, prospective study was performed. 748 Patients with mechanical valve replacement who had received oral anticoagulation. The patients were randomly assigned to three groups The intensity of anticoagulation for group one was standard intensity (INR:2.5-3.5). The intensity of anticoagulation for group two was kept at low intensity without adjustment (INR:1.8-2.6), and for group three , The intensity of anticoagulation maintained at low level initiatively (INR:1.8-2.6), D-dimer testing were analyzed two times at 3 month later. In case of D-dimer level elevated, adjusted the intensity of anticoagulation to standard level. The endpoint of the study was the subsequent thromboembolic and major bleeding during an average follow-up of 2 years.

Eligibility Criteria:
Inclusion Criteria:

1. age\>18years,male or female without pregnancy;
2. Suffered the mechanical valves replacement in Wuhan Asia Heart Hospital;
3. The operation type was Mitral valve replacement or Double valves replacement(aortic and mitral valve replacement).

Exclusion Criteria: Patients with following diseases within 3 months.

1. deep venous thromboembolism
2. Pulmonary embolism
3. Aortic dissection
4. stroke
5. Cerebral hemorrhage
6. Myocardial infarction
Screening an Orthopedic Population for Mildly-affected Individuals With Morquio Syndrome A and Maroteaux-Lamy Syndrome

The purpose of this study is to identify patients with Morquio syndrome type A (MPS IVA) and Maroteaux-Lamy syndrome (MPS VI) who may have been missed or misdiagnosed due to atypical clinical features, a milder course, and/or negative urine screening. We will recruit participants who have certain hip and/or joint problems that could potentially be caused by one of these two genetic conditions through a chart review process conducted at Shriners Hospital for Children in Greenville, SC. Diagnostic testing will be performed for each participant to determine if he or she is affected by one of these two conditions. Results will be disclosed to all participants and their legal guardians, and appropriate follow up will be recommended for those who are found to have abnormal results.


Eligibility Criteria:
Inclusion Criteria:

* Eligible participants must currently receive care in the Shriners Hospitals for Children system, and therefore, will be under 19 years of age.
* Eligible participants must have one of the following diagnoses: bilateral Legg-Calve-Perthes disease, bilateral hip dysplasia, multiple joint pain, unidentified skeletal dysplasia
* Eligible participants (or legal guardian) must be able and willing to sign informed consent/assent in English or Spanish.

Exclusion Criteria:

* Participants with one or more or the above inclusion diagnoses who have a specific etiologic diagnosis will not be eligible to participate in this study.
* If we are unable to obtain the necessary specimens, the participant will be removed from the study.
Normal Reference Ranges for Urinary Metabolites and Supersaturation Indices in Pediatric Populations

The reported normal values used in diagnosing and treating pediatric kidney stone formers are based on adult values or historic data from small studies. Urinary supersaturation indices which are now described in the adult stone literature as more sensitive predictors of stone composition, and precise predictors of response to therapy, are not established in children. The goals of this prospective study are to redefine normal values for pediatric urinary metabolites and supersaturation indices based on samples from a large number of healthy children and to identify if a difference in urinary supersaturations in children is protective.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female children between the ages of 3 and 18, inclusive, of all races who are toilet trained and who can submit a 24-hour urine sample

Exclusion Criteria:

* Active urinary tract infection
* Known urologic anatomic abnormality
* Personal or first-degree relative family history of urolithiasis or metabolic abnormality known to lead to urinary stone development
* Renal insufficiency
* Inability to collect a 24-hour urine specimen
* Intake of medications known to alter the risk of stone development such as steroids or diuretics or vitamins or calcium supplementation exceeding recommended daily allowances
* Adherence to restrictive diet for medical reasons
* Inflammatory or absorptive bowel disease
Comparison of Outcome and Complications Encountered in Flapless Surgery and Immediate Loading Versus the Classical Surgical Approach and Loading After 6-8 Weeks in the Posterior Maxilla

This study is a comparison of outcome and complications encountered in flapless surgery and immediate loading versus the classical surgical approach and loading after 6-8 weeks in the posterior maxilla.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older

Exclusion Criteria:

* Smoking
* Medical risk patients
Correlation of Laparoscopic Experience and Functional Brain Activation: A PET Scan Study

The purpose of the research is to determine how practicing laparoscopic motor tasks affects the functional anatomy of the brain, and to investigate whether there is a correlation between surgical experience and functional brain activition. Additionaly, the investigators plan to use eye-tracking technology to see if the use of this technology can distinguish surgeons of various skill levels. The investigators hope that this study leads to new and effective methods of training surgical residents. All of the data will be collected at The Feinstein Institute for Medical Research, and may be used in future studies, which may or may not be related to urological diseases.


Eligibility Criteria:
Inclusion Criteria:

1. Urology resident or fellow at Long-Island Jewish Hospital
2. Urology attending surgeon with previous laparoscopic experience
3. Medical Student Research Fellow with no previous laparoscopic experience
4. Right hand dominant subjects
5. No known neorologic defect reported by the subject -

Exclusion Criteria:

1. Left-hand dominant subjects
2. Self-reported neurologic defect reported by the subject -
Growth Hormone Evaluation in the Elderly People

The aim of this study is to evaluate the growth hormone (GH) and adrenocorticotrophic hormone (ACTH) secretion in elderly without hypothalamic-pituitary disease using the glucagon stimulation test (using Glucagen® Hypokit, Novo Nordisk A/S, Denmark) and evaluate some parameters such as sarcopenia, nutritional state, bone mineral density, frailty criteria with secretion of GH.

subjects over 65 years old were recruited from the geriatric ambulatory unit of our hospital to voluntarily participate in a research study concerning the GH and ACTH axis in the elderly, which included the realization of the glucagon stimulation test as the first phase of the study.

The GST (Glucagen® Hypokit, Novo Nordisk A/S, Denmark) was the chosen test to assess both ACTH and GH release because of its few known contraindications and mild side effects. It is a provocative test to evaluate GH and ACTH axis, i.e, a diagnostic test, without therapeutic effects.

Eligibility Criteria:
Inclusion Criteria:

* elderly people above 65 years old with comorbidities peculiar to their age (such as hypertension, diabetes, dyslipidemia, parkinson disease) or without comorbidities

Exclusion Criteria:

* pituitary disease, severe acute disease, terminal renal chronic disease, active malignant cancer, the presence of any other disease that could interfere with the somatotrophic axis evaluation, and the contraindications for glucagon administration (pheochromocytoma, insulinoma and malnourishment).