cyrilzakka/clinical-trials huggingface dataset:
The Effect of Cinacalcet on Gastric Acid Output in Healthy Subjects

The purpose of this study is to determine whether cinacalcet will increase gastric acid secretion in healthy volunteers.

The calcium sensing receptor (CaSR) was originally found on parathyroid and renal cells and more recently it has been identified on cells that regulate gastric acid secretion (G cells and parietal cells). However, its role in regulating acid secretion in humans is completely unknown and is of potential importance because an acid environment in the stomach enhances intestinal calcium absorption. In this pilot project, we will stimulate the CaSR with a CaSR-agonist called cinacalcet. Our hypothesis is that activation of the CaSR will in turn increase gastric acid production in healthy volunteers.

Eligibility Criteria:
Inclusion Criteria:

* Healthy ambulatory men and postmenopausal women
* Age 45 to 70
* Avoid alcohol, antacids, H2 blockers, proton pump inhibitors, or antihistamines during the study.

Exclusion Criteria:

* Ionized Ca++ level \<4.39 mg/dl or \>5.02 mg/dl (normal reference range 4.18- 5.02).
* 24-hour UCa++ excretion \>350 mg.
* Cr \>1.3.
* AST/ALT values \>10% beyond reference range.
* Hgb level \<11.7 g/dl in women and \<13.2 g/dl in men.
* MCV level \>102 UM3.
* Basal acid output \>5 mEq/h in men and \>3.8 mEq/h in women.
* Basal acid output \<1 mEq/h in men and \<0.2 mEq/h in women.
* Age \<45 or \>70.
* Premenopausal or \<1 year post-menopause.
* Individuals following vegan diets.
* Current EtOH abuse.
* Lidocaine allergy. Medications
* Antacids
* H2 blockers
* Proton pump inhibitors
* Carafate
* Anticholinergic agents (i.e. TCA)
* Cholinergic agents
* Antihistamines in the last 3 weeks
* Cogentin
* Adrenergic blockers
* Thiazide diuretics
* Antiplatelet drugs
* Oral and Inhaled Glucocorticoids
* Bisphosphonates
* Raloxifene, Tamoxifen
* Tobacco
* EtOH during study
* rPTH
* Calcitonin
* Ketoconazole/Itraconazole
* Calcitriol
* Paricalcitol
* Drisdol, Ergocalciferol
* Phosphate binders
* Anticoagulant
* Erythromycin
* Hormone replacement therapy except vaginal estrogen creams

Exclusion Diseases

* Achlorhydria
* Pernicious anemia
* Zollinger Ellison syndrome
* Congestive heart failure
* Esophageal strictures or motility problems
* History of a GI bleed
* Prior upper GI surgery
* Malabsorption
* History of GI malignancy
* GERD, gastritis, duodenitis
* Active peptic ulcer disease
* Gallbladder disease
* Liver disease
* Pancreatitis
* Current kidney stone
* Renal disease
* Current hypoparathyroidism or hyperparathyroidism
* Moderate to Severe coronary artery disease
* Aortic aneurysm
* Seizure disorder
* Current Arrhythmia
Pneumonia Chart Review Cambodia

This study aims to answer the question of what is the burden of lower respiratory disease (pneumonia) among children ages 1 month to 5 years of age in rural Cambodia. The primary objective will be to quantify the prevalence of severe pneumonia at Chenla Children's Healthcare, a hospital in the rural town of Kratie, Cambodia. This will involve a chart review of the medical records available at Chenla Children's Healthcare.


Eligibility Criteria:
Inclusion Criteria:

* Children between the ages of 1 month and 5 years admitted to Chenla Children's Healthcare with at least one admitting diagnosis being pneumonia or bronchiolitis will be included.

Exclusion Criteria:

* Children who do not fall into the aforementioned age range and who do not have "pneumonia" or "bronchiolitis" as one of the admitted diagnoses.
A Study of LY3532226 in Healthy Participants

The main purpose of this study is to evaluate the safety and tolerability of the study drug known as LY3532226 in healthy participants. Blood tests will be performed to check how much LY3532226 gets into the bloodstream and how long it takes the body to eliminate it. This study will last approximately 8 weeks including screening period.


Eligibility Criteria:
Inclusion Criteria:

* Overtly healthy males or females not of childbearing potential.
* Body mass index (BMI) within the range of 18.5 to 40 kilograms per meter squared (kg/m²), inclusive

Exclusion Criteria:

* Have a significant history of or current CV (e.g., myocardial infarction, congestive heart failure, cerebrovascular accident, venous thromboembolism), respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk while taking the study intervention; or of interfering with the interpretation of data
* Have a history of malignancy within 5 years prior to screening
* Have obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis
* Have serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>2X the upper limit of normal (ULN) or total bilirubin level (TBL) \>1.5X ULN
* Have serum triglyceride level ≥5 mmol/L (442.5 mg/dL)
* Have undergone any form of bariatric surgery
* Have received systemic or inhaled glucocorticoid therapy (excluding topical, intraarticular, and intraocular preparations); for more than 14 consecutive days within 4 weeks before screening
Impact of Intravenous Caffeine on Atrial Electrical Properties and Potential Arrythmia Induction

This "How caffeine Induces Atrial Tachyarrhythmias" trial will be a multi-center, randomized, double-blinded trial of intravenous caffeine versus placebo among patients undergoing pulmonary vein isolation procedures for Atrial Fibrillation(AF).

The mechanism by which caffeine might change cardiac electrophysiologic properties is largely unknown. Most of the prior studies conducted have evaluated the correlation based on the premise of oral consumption. One caveat among such study designs can be underreporting or overreporting the amount of caffeine ingested. To this date, no clinical trials exist that has studied the in vivo effects of caffeine to assess the atrial refractory period and conduction velocity and its potential to cause atrial or ventricular ectopy or sustained arrythmia induction including Atrial Tachycardia(AT)/Atrial Fibrillation(AF)/Ventricular Tachycardia(VT)/Ventricular Fibrillation(VF). As it is hypothesized that decreasing the atrial refractory period can render atria more prone to fibrillation. The pulmonary veins have proven integral to AF pathophysiology, the relationship between pulmonary vein electrophysiology and lifestyle factors in particular has not previously been assessed. It is also not clear if caffeine increases the risk of AF on those patients with known AF diagnosis. To bridge this gap, a randomized controlled trial is proposed to assess the effects of intravenous caffeine on atrial activity during AF ablation procedures.

Eligibility Criteria:
Inclusion Criteria:

All adult patients from 21-90 years of age with new onset Paroxysmal Atrial Fibrillation presenting in sinus rhythm or AF of recent onset (the latter confirmed by sinus rhythm documented no more than 1 week prior) undergoing AF ablation will be included in the study.

Exclusion Criteria:

Patients will be excluded if any of the following were identified:

1. History of substance abuse or alcoholism.
2. Left ventricular ejection fraction \<50%.
3. Liver dysfunction.
4. Pregnancy.
5. Inability to give informed consent.
6. Amiodarone uses within 1 month prior to procedure.
7. AAD use within 24 h prior to the procedure
8. Severe intolerance to caffeine.
Effect of Ezetimibe on Oxidized Low-density Lipoprotein (LDL) Cholesterol

Randomized study. Patients with coronary artery disease equivalent will be randomized to receive atorvastatin 40 mg/day + placebo vs. atorvastatin 40 mg/day + ezetimibe 40 mg/day. Oxidized LDL cholesterol will be measured at baseline and after 8 weeks of treatment. Hypothesis is that ezetimibe will lower oxidized LDL


Eligibility Criteria:
Inclusion Criteria:

* CAD or CAD equivalent

Exclusion Criteria:

* Prior CABG or PCI within 3 months Prior use of ezetimibe within 3 months Receiving atorvastatin 40 mg/day or 80 mg/day or any dose of rosuvastatin CHF NYHA stage \>2 Creatinin clearance \< 30 ml/min
OcuStem Nutritional Supplement in Diabetic Patients With Mild to Moderate Non-proliferative Retinopathy

The purpose of this study is to determine whether supplementation with OcuStem, a nutritional supplement, will reduce the progression of mild to moderate diabetic retinopathy.

This research study is designed to evaluate the effects of a nutritional supplement, OcuStem, on mild to moderate nonproliferative diabetic retinopathy. In this condition blood vessels in the back of the eye, an area termed the retina, are deteriorating. OcuStem contains ingredients that have previously been demonstrated in clinical trials to stimulate a type of cell, called "endothelial progenitor cells" to increase in circulation. Animal studies have shown that increasing endothelial progenitor cell numbers inhibits progression of diabetic retinopathy. The hypothesis of the study is that a 6 month course of OcuStem will reduce progression of mild to moderate diabetic retinopathy.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* One or both study eyes per subject may be enrolled.
* Diagnosis of diabetes mellitus (type 1 or type 2)
* Any one of the following will be considered to be sufficient evidence that diabetes is present:

  1. Current regular use of insulin for the treatment of diabetes
  2. Current regular use of oral anti-hyperglycemia agents for the treatment of diabetes
  3. Documented diabetes by ADA and/or WHO criteria.
* The study eye must meet the following:

  1. Presence of microaneurysms or at least mild non-proliferative diabetic retinopathy (level 20 or higher) on clinical exam.
  2. No presence of center-involved diabetic macular edema (DME) as evidenced by OCT central subfield thickness \<250 microns(or spectral domain OCT equivalent).
  3. Visual acuity light perception or better.

Exclusion Criteria:

* A current ocular condition that, in the opinion of the investigator, visual acuity might be affected now and/or may need to be treated (e.g., DME, foveal atrophy, pigment abnormalities, dense subfoveal hard exudates, nonretinal condition (cataract ), epiretinal membrane or vitro-macular traction) or during the course of the study (e.g., vein occlusion, uveitis or other ocular inflammatory disease, neovascular glaucoma, etc.).
* A history of a major ocular surgery (including vitrectomy, scleral buckle, any intraocular surgery, etc.) within prior 4 months or major ocular surgery including cataract removal anticipated within the next 4 months following enrollment.
* Pregnant Women
Timing of Morning Rounds for Postpartum Hospitalized Women

In postpartum hospitalized women, does delayed morning rounding improve patient satisfaction?

OBJECTIVE To investigate the timing of physician rounds on patient satisfaction

STUDY DESIGN Randomized, controlled, quality improvement trial

OUTCOMES Primary: score on Hospital Consumer Assessment of Healthcare Provers and Systems (HCAPS) survey

Secondary: score on Edinburgh Postnatal Depression Scale

Eligibility Criteria:
Inclusion Criteria:

* Delivered between 0600 and 0000
* Admitted to Memorial Hermann postpartum unit
* Patient managed by the University of Texas Physicians Group and/or obstetrics-gynecology residents

Exclusion Criteria:

- None
A Study of CS1001 in Subjects with Advanced Solid Tumors

This is a phase I, open-label, multiple-dose, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics and anti-tumor activity of CS1001 in subjects with advanced solid tumors.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects with metastatic or locally advanced unresectable solid tumor, who progressed following treatment with all available standard therapy, or for whom treatment is not available, not tolerated or refused.
2. ECOG performance status of 0 or 1.
3. Subjects must have at least one measurable lesion.
4. Patients with life expectancy ≥ 3 months.
5. Subject must have adequate organ function.
6. Fertile men and women of childbearing potential must agree to use an effective method of birth control from providing signed consent and for 180 days after last study drug administration.

Exclusion Criteria:

1. Known brain metastasis or other CNS metastasis that is either symptomatic or untreated.
2. Subjects with active autoimmune diseases or history of autoimmune diseases should be excluded.
3. Patients who have received prior therapies targeting PD-1, PD-L1, or CTLA-4.
4. Known history of HIV infection.
5. Subjects with active Hepatitis B or C infection.
6. Any unresolved CTCAE Grade ≥ 2 toxicities from prior anti-cancer therapy with the exception of vitiligo, alopecia.
7. Patients who have serious hypersensitive reaction to monoclonal antibodies, and have history of uncontrolled allergic asthma.
8. Known history of alcoholism or drugs abuse.
9. Subjects who received organ transplantation.
10. Known psychiatric disorders that would interfere with cooperation with the requirements of the trial.
11. Female subjects who are pregnant or breast-feeding; Male or female subjects of childbearing potential who refuse to use an effective method of birth control.

For more information regarding trial participation, please contact at cstonera@cstonepharma.com
Eziclen Drug Utilisation in Real Life Setting

The purpose of the study is to assess Eziclen/Izinova drug utilisation in the real life setting in a representative sample of the European target population.


Eligibility Criteria:
Inclusion Criteria:

* Patient eligible for a prescription of BLI800 (Eziclen®/Izinova®) as a cleansing bowel preparation in accordance with the marketing authorisation.
* Patient having provided written informed consent.

Exclusion Criteria:

* Patient not eligible for a prescription of BLI800 (Eziclen®/Izinova®) as a cleansing bowel preparation in accordance with the marketing authorisation. Specifically, patients in whom there is a contraindication for use of this product, including patients with congestive heart failure, severe renal insufficiency of active inflammatory bowel disease, are not eligible for inclusion in this study.
* Patient being prescribed a cleansing bowel preparation other than BLI800 (Eziclen®/Izinova®).
The Effect of Dramatization Simulation on Nursing Students' Ethical Attitudes

Nursing students face many ethical problems in their clinical practice. It is very likely that they will encounter ethical problems after graduation. For this reason, students should be given an ethical attitude before graduating. It is very difficult to gain an ethical attitude. Ethical issues, on the other hand, are very difficult to gain as they are a limited concept. Therefore, different methods should be used in teaching. Dramatization simulation is one of the teaching methods used recently. It is especially effective in making abstract concepts that are difficult to understand concrete. It is thought that students participating in a dramatized simulation will be effective in gaining ethical attitudes by recognizing ethical problems more easily. This research will be carried out to determine the effect of dramatization simulation on the ethical attitudes of nursing students.

The effect of dramatization simulation on the ethical attitudes of nursing students will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

\* Students who agreed to participate in the study

Exclusion Criteria:

* Not participating in dramatization simulation applications,
* Not participating in classroom ethical case studies
Efficacy and Safety of High Dose Vitamin D Supplementation in Patients Undergoing HSCT

Graft-versus-host-disease (GVHD) is common complication of hematopoietic stem cell transplantation. Vitamin D deficiency has been shown to be associated with increased risk of chronic GVHD in previous clinical studies. The purpose of this research is to investigate the effect of vitamin D supplementation in patients undergoing hematopoietic stem cell transplantation

Hematopoietic stem cell transplant candidates are randomized to vitamin D supplementation or usual care. Five milligrams (200,000 IU) of cholecalciferol is injected to intervention group before stem cell transplantation. Additional supplementation of cholecalciferol during follow-up period is determined according to the level of 25(OH)D3. The primary outcome is the incidence of chronic GVHD which is determined according to IBMTR criteria. The secondary outcome consists of the incidence of acute GVHD, incidence and severity of vitamin D deficiency, and serum concentration of 25(OH)D3. Study investigators expect that supplementation of vitamin D may improve the outcome of stem cell transplantation by reducing the incidence of chronic GVHD.

Eligibility Criteria:
Inclusion Criteria:

* Adults with ≥ 18 years old
* Diagnosed with hematologic maligancies
* Planned to undergo allogeneic stem cell transplantation

Exclusion Criteria:

* Hypercalcemia (ionized serum calcium level \[iCa\] \> 1.3 mmol/L, corrected serum calcium level \> 10.5 mg/dL)
* Impaired renal function (Serum creatinine ≥ 2.4 mg/dL)
* Not in complete remssion (except for myelodysplastic syndrome and myeloproliferative neoplasm)
* Consent withdrawal
* Considered inadequate under investigator's discretion
MRA and ABR as Early Predictors of Bilirubin-Induced Neurologic Dysfunction in Full-term Jaundiced Neonates

The aim of the research was to define the role of MRS and ABR as early predictors of bilirubin-induced neurologic dysfunction (BIND) in full-term neonates who required intervention (phototherapy or exchange transfusion).

Neonatal jaundice is a prevalent condition. It's typically a harmless phase that occurs as the body adjusts to bilirubin levels after birth, representing a balance between its production and elimination. When there's an increase in bilirubin production and a decrease in elimination, infants become at risk for dangerous hyperbilirubinemia, potentially leading to bilirubin encephalopathy.

The range of neurological issues caused by excessive bilirubin is referred to as bilirubin-induced neurologic dysfunction. Detecting this condition early is crucial to prevent irreversible brain damage. Some of the neurological effects include gliosis, demyelination, and interference with glutamate uptake by astrocytes in the basal ganglia. Magnetic resonance spectroscopy (MRS) is an advanced imaging technique that holds promise for identifying these metabolic changes and aiding in the diagnosis and evaluation of neonates with hyperbilirubinemia.

Bilirubin neurotoxicity particularly affects the auditory system, starting with the brainstem cochlear nuclei, followed by the auditory nerve. This damage can occur even without the classic signs of bilirubin encephalopathy and is known as auditory neuropathy spectrum disorder (ANSD). ANSD is characterized by abnormal auditory neural function, while cochlear microphonics and otoacoustic emissions remain normal.

The impact on hearing can vary from subtle issues in sound processing to complete deafness. Abnormal results in auditory brainstem response (ABR) tests can indicate the presence of acute bilirubin encephalopathy (ABE), serving as the most common and earliest sign of ABE.

Eligibility Criteria:
Inclusion Criteria:

* This study included term, appropriate for gestational age (AGA) neonates with pathological unconjugated hyperbilirubinemia who were candidates for intervention (Intensive phototherapy versus Exchange transfusion) using the American Academy of Pediatrics guidelines; 2004.

Exclusion Criteria:

1. Preterm neonates (less than 37 weeks).
2. Clinically moderate and severe acute bilirubin encephalopathy according to modified Bilirubin-induced neurologic dysfunction (BIND-M) score.
3. Neonates born with birth asphyxia and/or poor Apgar score.
4. Neonates with sepsis including CNS infection.
5. Neonates with family history of childhood hearing loss.
6. Congenital infection.
7. Chromosomal abnormalities.
8. Congenital ear anomalies associated with hearing loss or brain abnormalities including craniofacial anomalies.
9. Patients who were receiving ototoxic drugs as aminoglycosides.
10. Conjugated hyperbilirubinemia.
National Evaluation of the Adherence to Recommendations of Venous Thrombo Embolism Treatment in Cancer Patients

Treatment of venous thromboembolism in cancer patients is specific and has been validated in trials that favor the use of LMWH (Low Molecular Weight Heparin) instead of VKA (Vitamin K Antagonist) treatment during 6 months. International recommendations have diffused this option.It is necessary to evaluate the compliance of physicians to this treatment by measuring the number of patients with cancer treated with long term use of LMWH.


Eligibility Criteria:
Inclusion Criteria:

All patients with cancer present in the clinic, hospital, out patients diagnosed with a VTE during the 6 previous months. VTE can be symptomatic or asymptomatic, can be located close to a central line, and of any type (DVT, PE, SVT)

Exclusion Criteria:

* Patient already included in a trial studying antithrombotic therapy
* Patient refusing the study
* Patient under 18 and/or not competent to give informed consent
Immunogenicity and Safety of AdimFlu-S 2011-2012 in Non-Elderly Adult and Elderly Subjects

The purpose of this study is to evaluate the antibody response to each of the three influenza vaccine strains included in the licensed seasonal flu vaccine, as measured by hemagglutination inhibition (HAI) at 21 days post immunization in non-elderly and elderly subjects in compliance with the requirements of the current European Union (EU) recommendations for the evaluation of the immunogenicity for a new formulation of a licensed flu vaccine (CPMP/BWP/214/96).


Eligibility Criteria:
Inclusion Criteria:

* Males or non-pregnant females and aged ≥ 18 years;
* Willing and able to adhere to visit schedules and all study requirements;
* Subjects read and signed the study-specific informed consent.

Exclusion Criteria:

* Subject or his/her family is employed by the participated hospital;
* Subjects received 2010-2011 seasonal influenza vaccine within the previous 6 months;
* History of hypersensitivity to eggs or egg protein or similar pharmacological effects to study medication
* Personal or family history of Guillain-Barré Syndrome
* An acute febrile illness within 1 week prior to vaccination;
* Current upper respiratory illness, including the common cold or nasal congestion within 72 hours
* Subjects with influenza-like illness as defined by the presence of fever (temperature ≥ 38°C) and at least two of the following four symptoms: headache, muscle/joint aches and pains (e.g. myalgia/arthralgia), sore throat and cough
* Female subjects who are pregnant during the study
* Treatment with an investigational drug or device, or participation in a clinical study, within 3 months before consent
* Immunodeficiency, or under immunosuppressive treatment
* Receipt of any vaccine within 1 week prior to study vaccination or expected receipt between Visit 1 (study vaccination) and Visit 2 (final collection of blood samples);
* Receipt of any blood products, including immunoglobulin in the prior 3 months;
* Underlying condition in the investigators' opinion may interfere with evaluation of the vaccine