cyrilzakka/clinical-trials huggingface dataset:
Calcitonin Pre-treatment to Improve SPECT-CT Sensitivity

Patients with biochemically confirmed primary hyperparathyroidism and non-localizing SPECT-CT exam within the past year will be included. Subjects will be treated with calcitonin to lower calcium levels immediately prior to reimaging. The goal of this study is to determine whether lowering calcium will improve uptake/retention of sestamibi and improve sensitivity of SPECT-CT to localize parathyroid adenoma.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of primary hyperparathyroidism
* Non-localizing SPECT-CT performed within 365 days prior to consent to participate in study
* Patient desires surgical intervention for treatment of PHPT
* No contraindications to 99mTC-Sestamibi
* No contraindications to treatment with calcitonin
* Serum calcium level prior to non-localizing SPECT-CT is ≥10.5 mg/dL
* Patient consents to participate and undergo second SPECT-CT for purposes of research

Exclusion Criteria:

* Previous surgery to the neck, including resection of parathyroid tissue, except where end organ damage is present and further surgical intervention is medically necessary
* Contraindication to 99mTC-Sestamibi SPECT-CT as evidenced by allergic reaction or adverse event during index SPECT-CT
* Allergy to calcitonin
* Hypocalcemia (contraindication to calcitonin)
* Vitamin D deficiency (contraindication to calcitonin)
* Previous treatment with radioactive iodine
* New prescription of thyroid medication (levothyroxine, armour thyroid tablets, etc. must be taken at time of index scan and research scan)
* Lithium exposure within one year of SPECT-CT (index and research scans)
* Secondary hyperparathyroidism
* Benign familial hypocalciuric hypercalcemia
* Known malignancy, particularly multiple endocrine neoplasia
* New prescription of thiazide diuretic, (thiazide diuretic must have been taken at the time of index scan and second scan)
* Currently taking calcium channel blockers
* Pregnancy
Identification of Bacterial and Fungal Isolates in Patients with Sinonasal Polyps

To detect bacterial and fungal growth in patients with sinonasal polyps undergoing FESS

Chronic rhinosinusitis with nasal polyps (CRSwNP) is a disease of the nose and paranasal sinuses characterized by mucosal thickening and polyp formation¹ which are inflammatory lesions that project into the nasal airway and are typically bilateral² .Chronic rhinosinsitis with nasal ployps (CRSwNP) affects 0.5% to 4% of the population worldwide. ³ Symptoms include anterior or posterior rhinorrhea, nasal congestion, hyposmia, and/or facial pressure or pain that last for a duration of more than 12 weeks.² The cause of the sinonasal polyps is still unknown but they may be associated with several pathological conditions i.e. infection, allergic fungal sinusitis, allergy and cystic fibrosis ⁴. Many studies were based on detection of bacterial and fungal growth in sinonasal polyps , and found that preoperative bacterial culture showed growth of Staphylococcus coagulase negative (CONS) ,Staphylococcus aureus , gram -ve bacteria i.e. Pseudomonas aeruginosa , Klebsiella pneumoniae , Klebsiella ozenae and Escherichia coli⁴ . From fungi , Aspergillus species were the most commonly recovered isolates ⁵. The initial approach of management was medical treatment . Medical therapy consists of administration of intranasal or systemic steroids. Other medical treatments considered the use of antibiotics, leukotriene modifiers, and avoidance of acetylsalicylic acid. Surgical removal was performed for non-responders to medical management⁶. Functional endoscopic sinus surgery (FESS) is a minimally invasive technique in which sinus air cells and sinus ostia are opened under direct visualization. The goal of this procedure is to restore ventilation and normal functions⁷.

Eligibility Criteria:
Inclusion Criteria:

- 1. Adult patients (18 and over )

2. Patients with sinonasal polyposis confirmed with nasal endoscopy and Computed tomography and undergoing FESS

Exclusion Criteria:

* 1.Chronic rhinosinsits without nasal polyps 2. Patients below 18 years old and above 70 years old 3. Immunocompromised patient. 4. Recent administration of antibiotics or antifungal medication . 5. Unilateral nasal polyp , granuloma and tumors
Relationship Between Renal Function and Pharmacokinetics of Apixaban and Clinical Outcome of Apixaban in Thai Non-valvular Atrial Fibrillation Patients

The purpose of this study is to assess pharmacokinetics and pharmacodynamics of Apixaban and clinical outcome of Apixaban in Thai patients with nonvalvular atrial fibrillation with varying degree of creatinine clearance

This study is divided into two parts.

The first part is a multiple dose pharmacokinetic and pharmacodynamics study of Apixaban in patient with stable renal function. The primary purpose of this study is to provide a clear understanding of the effect of creatinine clearance on pharmacokinetics and pharmacodynamics of Apixaban among Thai patients with nonvalvular atrial fibrillation. To assess the pharmacokinetics and pharmacodynamics of Apixaban, This study will enroll 30 subjects who meet the inclusion criteria.

The second part of this study will retrospectively determine the occurrent of clinical outcome between patients who were prescribed apixaban dose concordant and discordant to the drug leaflet. A total of 241 subjects will be recruited. The follow up period will begin from the time of initiation of apixaban until occurrent of stoke, transient ischemic attack, systemic embolism, bleeding, or death.

Eligibility Criteria:
Part I

Inclusion Criteria:

* Patients with nonvalvular atrial fibrillation
* Patients who is receiving a stable dose of apixaban for primary or secondary prevention of stroke, transient ischemic attack, and systemic embolism.

Exclusion Criteria:

* Pregnant or lactating
* End stage renal disease patients who required chronic renal replacement therapy to sustained life
* History of acute kidney injury within the previous 3 months
* Severe hepatic impairment (Child-Pugh class C)
* Any gastrointestinal disorder that could impact the absorption of study drug
* CYP3A4 Moderate/Strong Inhibitors: ketoconazole, itraconazole, voriconazole, posaconazole, ritonavir, naproxen, clarithromycin, rifampicin, phenytoin, carbamazepine, phenobarbital, diltiazem, and St.John's Wort

Part II

Inclusion Criteria:

* Patients with nonvalvular atrial fibrillation
* Patients who was prescribed apixaban for primary or secondary prevention of stroke, transient ischemic attack, and systemic embolism.

Exclusion Criteria:

* Pregnant or lactating
Elderly Sleep Disturbance Through Home Care Solution

Humans spend a third of their time on sleep. Therefore, maintaining a deep, stable and consistent sleep is very important for a good quality of life. Aging is often related to a decrease in the ability to fall asleep and maintain sleep. Getting older, various factors can worsen the normal sleep process, which is essential for restoring function and body function. Aging-related diseases, life changes, or own aging can disrupt the normal sleep cycle and seriously affect healthy aging. For example, the circadian rhythm and sleep consolidation will be broken with normal aging. These changes may lead to aging, or become part of the risk factors for diseases such as Alzheimer's disease. How to avoid disability and dementia by improving the quality of sleep to make the elderly healthy and aging, will bring huge effects to the economy, society, and health care.

From this plan, investigators will participate in an integrated plan (main plan)-" Integrating Systematic Data of Geriatric Medicine to Explore the Solution for Healthy Aging". In the main plan, 500 subjects will be enrolled. All subjects consent to provide medical record and will be tested for sarcopenia, including body composition, 4-meter walk, handgrip strength. The subjects screened sleep-affected subjects. It is estimated that 250 people will be invited for home sleep testing, such as continuous positive pressure breathing aid (CPAP) for sleep apnea (OSA) (approximately 120 subjects). For non-OSA and non-periodic limb movement disorder (PLMS) sleep problems, take a phototherapy program (about 60 subjects). The following goals are expected to be achieved:

1. Link to the main project to explore the correlation between common sleep disorders in the elderly and blood pressure, cognition, sarcopenia, metabolomics or intestinal microbiome
2. To verify the prognosis of sleep apnea and sleep disorders after intervention.


Eligibility Criteria:
Inclusion Criteria:

* Those who are willing to sign the written subject consent
* Participants who participated in the integrated project (main project) - "Integrating Systematic Data of Geriatric Medicine to Explore the Solution for Healthy Aging"
* The results of the sleep questionnaire meet one of the following:

  1. Pittsburgh Sleep Quality Scale (PSQI) \> 5 points
  2. The Self-Sleep Assessment Questionnaire (STOP-BANG) is at high risk for sleep apnea (OSA)

Exclusion Criteria:

* Patients with severe cataracts who have not received treatment, patients with color blindness and chronic skin diseases (including psoriasis, eczema), or those who are considered by the host to be unable to receive light therapy.
* Those who are unsuitable after evaluation by a physician.
The Intrathecal Morphine for Nephrectomy

To evaluate the efficacy and the safety of the intrathecal morphine injection in the open nephrectomy.

The open nephrectomy is the treatment of choice for live donor kidney transplantation and renal cell carcinoma. The incision for the nephrectomy causes severe postoperative pain. A single dose of intrathecal morphine(ITM) has been used for the postoperative pain of prostatectomy, transurethral resection of the prostate and hepatectomy. The effect of ITM for open nephrectomy has not been studied. Therefore, this prospective, randomized study will evaluate the efficacy and safety of a single 50 mcg dose of ITM added to intravenous patient controlled analgesia(IV-PCA), comparing to IV-PCA alone.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for the open nephrectomy

Exclusion Criteria:

* Patients with renal insufficiency
* Patients with coagulopathy
* History of any neurologic disorder
* History of recent infection in 2 weeks
* History of drug abuse
* Patients who cannot understand the usage of th intravenous patient-controlled analgesia
* Patients using opioids due to the chronic pain
Assessing the Impact of Dosage Frequency of Propranolol on Sleep Patterns in Patients With Infantile Hemangiomas

The purpose of this study is to assess the baseline sleep pattern disruption for patients starting oral propranolol at the standard BID dosing regimen compared to the control (timolol) group and to determine if there is a significant improvement in the sleep patterns in infants taking oral propranolol on the TID dosing regimen versus the control (timolol) group


Eligibility Criteria:
Inclusion Criteria:

* clinically diagnosed hemangiomas.
* English or Spanish speaking only

Exclusion Criteria:

* Parents who do not consent to the study.
* Significant cardiac or pulmonary disease who are unable to tolerate oral propranolol
Effects of Subanesthetic Concentrations of Isoflurane/Nitrous Oxide - 3

The purpose of this study is to conduct experiments to examine subjective and reinforcing effects of nitrous oxide. Mood altering and psychomotor effects will be tested on non-drug abusers and preference procedures will be used to assess reinforcing effects. To evaluate the acute and residual effects of subanesthetic concentrations of isoflurane/nitrous oxide combinations in healthy volunteers.


Eligibility Criteria:
Please contact site for information.
Efficacy of L-Ornithine-L-Aspartate in Cirrhotics With Hepatic Encephalopathy

The purpose of this study is to determine whether L-Ornithine L-Aspartate is effective for the improvement of Overt Hepatic Encephalopathy.

There is no effective treatment available for hepatic encephalopathy at the moment; therefore we aimed to check the efficacy and safety of L-ornithine L-aspartate(LOLA). It provides critical substrates for ureagenesis and glutamine synthesis, the two primary mechanisms by which the body rids itself of excess ammonia. Ornithine is a specific activator of ornithine carbamyl transferase and carbamylphosphate synthetase, and, in addition, is a substrate for ureagenesis. These reactions are carried out mainly in the periportal portion of the hepatic lobules. Aspartate and ornithine, after conversion to alfa-ketoglutarate, are substrates for glutamine synthesis, which is performed exclusively by a small population of perivenous hepatocytes, the so-called perivenous scavenger cells. The ammonia lowering effect resulting from the stimulation of these two basic mechanisms of ammonia detoxification has been studied in animals and was confirmed in humans in clinical trials.

Eligibility Criteria:
Inclusion Criteria:

* Cirrhosis, diagnosed on the basis of clinical findings, sonographic, and/or histologic basis,
* Patients \>14 years, with HE grades 1 to 4 according to West Haven Criteria,
* Hyperammonemia (fasting venous blood ammonia level \>60 µmol/l), and
* Patients with a single reversible precipitating factor of HE such as constipation, hypokalemia, urinary tract infection, respiratory tract infection, spontaneous bacterial peritonitis (SBP), dehydration, or none.

Exclusion Criteria:

* hepatocellular carcinoma,
* severe septicemia,
* active gastrointestinal bleeding,
* hepatorenal syndrome,
* acute superimposed liver injury,
* advanced cardiac or pulmonary disease and end stage renal failure,
* patients with minimal HE
* patients taking sedatives, antidepressants, or benzodiazepines and
* patients with chronic HE on metronidazole or lactulose prior to admission.
Pharmacokinetic and Safety Study of Raltegravir and Atazanavir in a Once Daily Dose Regimen in HIV-1 Infected Patients

The licensed dose of raltegravir is 400 mg twice daily with or without food. Raltegravir is metabolized predominantly through glucuronidation by UGT1A1. Atazanavir increases the plasma concentrations of raltegravir 400 mg twice daily by 72% due to inhibition of UGT 1A1.

This suggests that combined use of atazanavir and a lower dose frequency of raltegravir, once daily for example, is possible. Another reason why raltegravir most likely can be applied is that its pharmacodynamic effect is not related to Cmin but to AUC which is expected to be similar for an 800mg QD dose when compared to 400mg BD. Phase III clinical trials evaluating QD dosing of raltegravir are currently ongoing and interim results are expected to be published in mid 2009.

A regimen of atazanavir and raltegravir in combination with lamivudine or emtricitabine may be a well tolerated and effective NNRTI-, and ritonavir-sparing regimen that could be an attractive option for both first and second line (after NRTI/NNRTI failure) treatment regimens.


Eligibility Criteria:
Inclusion Criteria:

* HIV-infected as documented by positive HIV antibody test and confirmed by Western Blot.
* Subject is at least 18 years of age at the day of screening.
* Subject is able and willing to sign the Informed Consent Form prior to screening evaluations.
* HIV-1 RNA \< 40 copies/mL for at least 6 months on antiretroviral therapy.
* Subject has no history of previous virological failure or documented resistance mutations

Exclusion Criteria:

* History of sensitivity/idiosyncrasy to the drug or chemically related compounds or excipients, which may be employed in the trial.
* Relevant history or current condition that might interfere with drug absorption, distribution, metabolism or excretion.
* Inability to understand the nature and extent of the trial and the procedures required.
* Pregnant female (as confirmed by an HCG test performed less than 3 weeks before the first dose) or breast-feeding female.
* Abnormal serum transaminases determined as levels being \> 5 times upper limit of normal (see Appendix A for normal ranges of clinical laboratory values).
* Concomitant use of medications that interfere with raltegravir or atazanavir pharmacokinetics: rifampicin, irinotecan, midazolam, triazolam, ergotamine, dihydroergotamine, cisapride, pimozide, lovastatin, simvastatin, indinavir, proton pump inhibitors, H2 receptor antagonists, St. john's wort, Ginkgo Biloba, didanosine, tenofovir, efavirenz, nevirapine, antacids, clarithromycin, phenytoin, phenobarbital, carbamazepine.
* Active hepatobiliary or hepatic disease (including chronic hepatitis B infection).
* Alcohol abuse.
Evaluation of Non-invasive Measurement of Electrophysiological "HV" Interval Using a High-density and High-fidelity Signal Averaging ECG Device

His-Ventricle (HV) measurement is only obtained invasively using transvenous catheters. This kind of procedure is routinely performed but some risks of complication exist. HV interval prolongation is correlated with increased risk of occurrence of complete atrioventricular block which could lead to syncope or cardiac sudden death. A new non invasive, high density and high fidelity system (BioSemi, BioSemi B.V., Amsterdam, Netherlands) can theorically collect such electrophysiological signal using a signal averaging acquisition method. We want to assess the possibility of non invasive HV interval measurement using this new device.


Eligibility Criteria:
Inclusion Criteria:

* Patients admitted at Bordeaux University Hospital for electrophysiological study with HV measurement.

Exclusion Criteria:

* Patients under 18 years old,
* Pregnant or breastfeeding women.
Systematic Approach for the Diagnosis and Treatment of Obstructive Lung Diseases

The differential diagnosis of asthma and COPD is sometimes difficult. Recently, an overlap syndrome has been defined based on the concurrence of asthma and COPD characteristics. These characteristics are based on expert opinions and have never been investigated nor validated prospectively.

The investigators assume that the management strategy, the symptom burden and disease progression will differ between asthma, COPD and ACOS. Therefore, the study wants to establish baseline criteria for an appropriate disease definition and evaluate the potential impact on treatment and symptom control.

This study aims to test a diagnostic algorithm for obstructive airways diseases that may be used in daily practice to obtain a correct differential diagnosis and, hence, initiate an adequate therapy according to the current guidelines. The proposed algorithm will be used to categorize patients in 4 different diagnoses with specific treatment choices: asthma, obstructive asthma, overlap asthma with COPD, and COPD. The study will evaluate which tests and criteria contribute most to the diagnostic work-up and final diagnosis.

Test battery for diagnosis

* spirometry with bronchodilator reversibility testing
* bodyplethysmography: spirometry, volumes, resistance, diffusing capacity
* exhaled NO
* blood sample
* CT scan of thorax (only when obstructive spirometry)
* histamine challenge (only when spirometry is not obstructive)
* induced sputum (not for protocol interpretation)

Definition of endpoints

1. Physician based diagnosis:

   diagnosis based on clinical exam and spirometry
2. Algorithm based diagnosis:

   diagnosis based on clinical exam and test battery
3. Final standard diagnosis diagnosis based on clinical exam, test battery and clinical evolution of 1 year.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with respiratory symptoms suggestive of chronic airway disease

Exclusion Criteria:

* Subjects with an immediate need for hospitalization or a treatment of systemic glucocorticoid or long-term antibiotics
* Subjects with pregnancy
* Subjects with clinically significant cardiovascular disease that warrants intervention
* Subject with concomitant pulmonary diseases (pulmonary embolism, interstitial lung disease etc..).
Correlation Between Peripheral and Central Venous Blood Partial Pressure of Carbon Dioxide in Critical Ill Patients

Observational study to analyze correlation between partial pressure of carbon dioxide from blood obtained from peripheral and central veins


Eligibility Criteria:
Inclusion Criteria:

* All patients admitted to institutional ICU with central venous catheter in place
* Venous blood gas analysis ordered

Exclusion Criteria:

* Central venous catheter malposition
* Difficult peripheral venous access
Calibrated Diets and Human Intestinal Microflora

The main objective of the study is to realized a collection of feces in order to study the modification of the intestinal microflora according to alimentary fibres

Human intestinal tract count up to 1014 bacteria. We consider that each bacterial flora is composed of more than 500 different species among which only 20% are cultivable. Although this flora is well unknown, it is known that it play a major role in the metabolism of the eating fibers. Dysfunctions of this flora may be implied in numerous local and general pathologies.

It has been shown that probiotics and prebiotics are able to act upon the intestinal flora. On the basis of the personal real-life, it is generally considered acquired that our diet modifies this flora. However not many studies have validated this hypothesis with human normal diet (not artificially enriched with prebiotics or probiotics). The idea that our diet can modified the functioning of our intestinal flora (and so favor certain pathologies or activate recovery) is widely hypothetic.

A best knowledge of the diversity of this flora and to put at disposal tools to study it on a large scale could allow to answer this question. The demonstration that some food components could modify the composition or the functioning of this flora would have considerable consequences in medicine and food processing industry.

Eligibility Criteria:
Inclusion Criteria:

* BMI between 18,5 and 25

Exclusion Criteria:

* Antibiotherapy in the previous month
* Current Antibiotherapy
* Gastro-intestinal dysfunction
* Pregnancy, parturient and feeding woman
* Person deprived of freedom by judiciary or administrative decision, person in legal protection,
* Prebiotic and/or osmotic laxatives in the previous month
* Preparation for coloscopy in the previous month