cyrilzakka/clinical-trials huggingface dataset:
Evaluation of the Pharmacokinetics of Caspofungin in ICU Patients

Although the pharmacokinetics of Caspofungin has been studied in healthy subjects and patients, only a few studies have been performed in critically-ill patients. In these patients several factors, including sepsis, shock, increased distribution volume, hepatic dysfunction and hypoalbuminemia may result in dramatic changes in antibiotic concentrations and pharmacokinetics. Caspofungin pharmacokinetic data is scarce and are results mainly from case series or animal studies. Thus, studies performed so far show Caspofungin trough concentrations either decreased, similar to usual value in non-critically ill patients or increased. One of these studies suggested that body weight and hypoalbuminemia may be the main factors associated with Caspofungin pharmacokinetic variability. Pharmacokinetic parameters of caspofungin in pigs with hypovolemic shock suggested the peripheral volume of distribution of caspofungin and intercompartmental clearance to be higher than in healthy animals. These results are however preliminary and cannot be extrapolated suggesting further clinical studies in human to be needed.

The primary objective of this study is to assess Caspofungin trough concentrations and pharmacokinetics in critically-ill patients requiring vasopressors.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (age \> 18 y.o)
* Either preemptive, empirical or curative prescription of Caspofungin by one of the ICUs' attending physician
* Requiring vasopressors
* Admission in one of the participating ICUs.

Exclusion Criteria:

* Pregnancy
* Lack of affiliation to the National Medical Insurance
* Previous inclusion in the study
* Inclusion in a concomitant study that may interact with the current study
Impact of Proximal Colon Retroflexion in Colorectal Cancer Screening Programme

Colorectal cancer (CRC) is the most common tumor and the second leading cause of death in the Western world. The decrease in incidence and mortality by CRC in the population undergoing screening has been observed. Colonoscopy is the recommended method for detecting tumors in early stages, as well as identifying and resecting adenomatous polyps, which are the precursor lesions of most CRCs. Colonoscopy should be of high quality to decrease incidence and mortality by CRC and avoid interval cancer. The literature shows that colonoscopy does not prevent right colon lesions in the same way as the left colon lesions, with most of the interval cancers located in the right colon. Studies published so far show an increase in the adenomas detection rate (ADT) in the right colon in the second visualization of this segment and an increase between 2 and 10% if this second examination is performed with the proximal retroflexion maneuver.Retroflexion is a safe maneuver in expert endoscopists. The aim of our study is to evaluate the ADT in the right colon by means of a second visualization by performing proximal retroflexion or second frontal visualization at random in the CCR screening population.


Eligibility Criteria:
Inclusion Criteria:

* Subjects participating in the Colorectal cancer Screening program with faecal immunological test \> 100ng / ml.
* Ages between 50-69 years.
* Adequate preparation according to the Boston scale: in right colon (score\> 2 in this section)
* Informed consent.

Exclusion Criteria:

* Refusal to give informed consent.
* Subjects with elevated colorectal cancer risk due to family history or inherited diseases of polyposis or inflammatory bowel disease
* Symptomatic subjects.
* Diverticulitis, inflammatory bowel disease or colonic stenosis during the exploration
* Inadequate preparation according to Boston cleanliness scale (score ≤ 2 in right colon)
EBUS vs EUS-B for Diagnosing Sarcoidosis

Rationale:

Endosonography with mediastinal/ hilar nodal sampling is the test of choice to diagnose sarcoidosis stage I and II - in case tissue verification of noncaseating granulomas is indicated. However, the optimal endosonographic approach (endobronchial or transoesophageal) for mediastinal nodal sampling is under discussion.

Secondly, which needle size or type provides optimal tissue sample quality for granuloma detection is unknown. The novel 25 Gauge (G) beveled ProCore needle, allows tissue acquisition of small core biopsies in addition to cytological aspirates.

Hypotheses:

1. Esophageal ultrasound guided (EUS-B) sampling of intrathoracic lymph nodes has a 14% higher granuloma detection rate compared to endobronchial ultrasound (EBUS) guided nodal sampling in patients with suspected sarcoidosis stage I/II.
2. 25G ProCore needles provide superior sample quality compared to conventional 22G needles in patients with suspected sarcoidosis stage I/II.

Study design:

Investigator initiated, randomized clinical trial. Setting: International, multicenter (university and general hospitals)

Study population:

Consecutive patients with a clinical and radiologic suspicion of sarcoidosis stage I or II and an indication for tissue verification of non-caseating granulomas are eligible for inclusion.

Intervention:

EBUS vs EUS-B, simultaneously comparing the standard vs novel ProCore needles.

Main study endpoints:

1. The granuloma detection rate of endobronchial (EBUS) guided sampling of intrathoracic lymph nodes compared to esophageal (EUS-B using the EBUS scope) guided sampling in patients with suspected sarcoidosis stage I/II.
2. Sample quality of conventional 22G vs. 25G ProCore needles in patients with suspected sarcoidosis stage I/II.


Eligibility Criteria:
Inclusion Criteria:

* Clinical and radiologic suspicion of sarcoidosis stage I (mediastinal or hilar lymphadenopathy) or stage II (lymphadenopathy and interparenchymal abnormalities)
* Indication for tissue verification of noncaseating granuloma's
* Provision of a written informed consent

Exclusion Criteria:

* Life expectancy of less than 6 months
* Obvious organ involvement of sarcoidosis with the possibility to confirm granulomas with a minimally invasive diagnostic procedure (eg skin lesion or superficial lymph node)
* Positive acid-fast bacilli sputum test
* Contra-indication for endosonography
* Pregnancy
Safety and Efficacy Study of Autologus Bone Marrow Mesenchymal Stem Cells in Multiple Sclerosis

1. Expanding and priming Bone Marrow (BM)- Mesenchymal Stem Cells (MSCs) to a clinical scale according to Good Laboratory Practice using xenogenic free media instead of the previously used FCS.
2. Assessing the safety of injecting autologous BM-MSCs to Multiple Sclerosis (MS)patients who fail to respond to conventional treatment.
3. Assessing the therapeutic benefits on the participants in the trial as per established methods.


Eligibility Criteria:
Inclusion Criteria:

* A clinical diagnosis of definite MS according to the revised McDonald Criteria.
* Expanded Disability Status Scale (EDSS) ≤ 6
* Failure of standard medical therapy
* Disease duration of at least three years prior to enrollment.

Exclusion Criteria:

* Pregnant and lactating women
* Previous treatment with immunosuppressive agents in the last 12 months prior to enrollment
* Recent MS relapse in the month prior to enrollment
* Treatment with oral or parenteral steroids for any cause in the month prior to enrollment
* Significant systemic medical disorders including cardiac, renal, hepatic, hematologic, immunologic or endocrine disorders
* Previous treatment with interferons or glatiramer acetate in the 3 months prior to enrollment
* Any contra-indication for magnetic resonance imaging (MRI) or gadolinium contrast.
* Positive serology for HIV, Hepatitis B or Hepatitis C
* Any history of malignancy or exposure to radiation at any time prior to enrollment
* Any contra-indication to lumbar puncture
* Severe cognitive impairment that would interfere with the patient's ability to understand and sign the informed consent.
Nasal Spray With Glucose Oxidase Preventing Common Cold in Pre-school Children

To investigate if use of glucosoxidas nasal spray can reduce the number of days with upper respiratory tract infections in children beyond 4 years.

Children below 4 years of age and in public day care were invited to participate in this prospective study. The children started with a visit to an ENT doctor and after inclusion the children started to spray twice daily with glucose oxidase+glucose or only saline+glucose for 3 months. During this period the parents were asked to fill in a home protocol recording upper respiratory tract symptoms as: rhinitis, cough, fever, ear ache. After 6 weeks and 12 weeks the children had scheduled visits to the ENT department, where an ENT doctor examined the throat, nasal cavity and the ear drums for otitis media. After 12 weeks of treatment a nasopharyngeal swab was taken for bacterial culture.

Eligibility Criteria:
Inclusion Criteria:

* Children below 4 years of age

Exclusion Criteria:

* None
Evaluation of the Effect of Rosuvastatin on Cisplatin-induced Nephrotoxicity and Ototoxicity

Cisplatin is an effective anti-cancer drug for the treatment of many solid tumors in humans. Although the clinical response to cisplatin chemotherapy is encouraging, the nephrotoxicity and ototoxicity of the drug makes it difficult to continue its administration in many cases.

Cisplatin nephrotoxicity occurs through several mechanisms, mainly through the transport and accumulation of cisplatin into renal epithelial cells, injury to nuclear and mitochondrial DNA, activation of multiple cell death pathways and initiation of inflammatory response. Accordingly, several experimental strategies were developed to prevent this toxicity. For example, drugs that reduced renal cisplatin accumulation such as organic cation transporter 2 (OCT2) and copper transporter (Ctr1) inhibitors, antioxidants, antiapoptotic and anti-inflammatory agents were investigated. However, many of these drugs interfered with the cytotoxic effects of cisplatin.

Statins are agents used for reducing plasma cholesterol through the inhibition of the enzyme 3- hydroxy-3- methylglutaryl coenzyme A (HMG-CoA) reductase. In addition, statins are also proven to have pleiotropic, non-lipid dependent effects. These effects include anti-inflammatory actions and reduction of oxidative stress. Based on animal studies performed, statins have been shown to reduce the nephrotoxic effects of cisplatin in rats. In addition, ongoing clinical trials are aiming to investigate the role of statins in the protection against the ototoxicity of cisplatin as well. Our aim is to assess the protective effect of statins on cisplatin-induced nephrotoxicity and ototoxicity in humans.


Eligibility Criteria:
Inclusion Criteria:

* Histologically proven lung and breast cancer patients indicated for cisplatin (4-6 cycles)
* Normal baseline serum creatinine levels
* Normal baseline audiometry
* Age between 18-70 years

Exclusion Criteria:

* Patients with more than one type of cancer
* Patients with prior chemotherapy treatment
* Treatment with statins within 12 months before assignment
* Treatment with fibrates within 4 weeks before assignment
* Pregnancy and Lactation
* Abnormal liver function tests or blood count
Adipokines and the Risk of Reflux Esophagitis

We aimed to risk faoctors for GERD and association between visceral obesity, plasma adipoline(leptin, adiponectin, IL-6, TNF-α)and development of reflux esophagitis in healthy Koreans.


Eligibility Criteria:
Inclusion Criteria:

* endoscopically proven reflux esophagitis

Exclusion Criteria:

* those with esophageal hiatal hernia, current PPI medication, upper GI operation history
Training Procedural Simulation of Nurses in Reducing Complications Related to Arteriovenous Fistula Puncture

Interest of training in procedural simulation of nurses in the reduction of complications related to arteriovenous fistula puncture in hemodialysis patients

Primary objective :

To compare the number of complications related to arteriovenous fistula (AVF)puncture before and after a complete simulation training program, on a fistula arm of procedural simulation (conceptualization of the approach + puncture + palpation + identification + use of ultrasound)

Secondary objective (s):

Compare other adverse events related to AVF puncture during a hemodialysis session

Eligibility Criteria:
Inclusion Criteria:

* Patients whose nurse is trained in hemodialysis receiving a FAV puncture in the hemodialysis unit of the nephrology department, dialysis, transplantation

Exclusion Criteria:

* Patients with AVF puncture in the emergency / withdrawal area of the nephrology department, dialysis, transplantation
Optimization of an Automated Ultrasound Cardiac Guidance Tool

Open-label, single-arm, prospective study. Subjects will undergo one session of 2D Transthoracic Echocardiogram (2D-TTE) ultrasound. The ultrasound will be performed by a trained sonographer.

The study will use a commercially available handheld imaging device (Philips Lumify transducer).

Primary Objective:

To acquire images of multiple transducer position, trajectories, and views, at different acoustic windows for capturing images and location relative to body and probe positions.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years and above.
2. Patients able to understand, read and sign the informed consent
3. Patient willing to answer a short questionnaire

Exclusion Criteria:

1. Pregnancy(females of childbearing potential will be tested with a urine pregnancy test prior to their inclusion in the study)
2. Not willing or not able to sign an inform consent
3. Physical limitation to maneuvering the probe on the body
4. Unable to lie flat for study
5. Patients experiencing a known or suspected acute cardiac event
6. Patients with severe chest wall abnormalities
7. Patients who have undergone pneumonectomy
8. Patients whose anatomy does not lend itself to echocardiography
Hypertension as a Reason for Concellation of Elective Minor Abdominal Surgery

During the anesthesia outpatient consultation, patients proposed for minor abdominal surgery, known hypertensive patients are selected.

On the day of the procedure, we check the blood pressure figures. If the numbers are high: SBP ≥ 180 and/or PAD≥110: we start by a filling as well as a dose of 1 mg Midazolam IV and the blood pressure figures are re-evaluated. If 3 measurements blood pressure figures remain above the threshold values: Surgery is postponed and the patient will be included to group (A) for canceled. If the blood pressure figures are correct, the surgery is accepted and the patient will be included in the group (NA) for not canceled.

During the anesthesia outpatient consultation, patients proposed for minor abdominal surgery, known hypertensive patients are selected. If the blood pressure figures are balanced in the previous 12 months, they are included in the study and the anesthesiologist informs them of the study protocol and obtains their consent.

On the day of the procedure, the patient is admitted to the operating room. We begin warming the patient and carry out standard monitoring, then, we check the blood pressure figures. If the numbers are high: SBP ≥ 180 and/or PAD≥110: we start by a filling as well as a dose of 1 mg Midazolam IV and the blood pressure figures are re-evaluated. If 3 measurements blood pressure figures remain above the threshold values: Surgery is postponed and the patient will be included to group (A) for canceled. If the blood pressure figures are correct, the surgery is accepted and the patient will be included in the group (NA) for not canceled.

Eligibility Criteria:
Inclusion Criteria:

* patients aged 18 or over, consenting
* known hypertensive patients.
* Patients proposed for planned minor abdominal surgery (≤ 2 hours).

Exclusion Criteria:

* patients not premedicated (antihypertensive treatment)

Non-inclusion criteria:

* patient refusal .history of hypertensive emergency within 06 months.
Growth Hormone Replacement Therapy for Retried Professional Football Players

This is a randomized, double-blind, placebo-controlled, parallel-group trial with an open-label extension to evaluate the efficacy of growth hormone (GH) on cognitive functions of retired professional football players with growth hormone deficiency (GHD).

GHD is the most common anterior pituitary abnormality after traumatic brain injury (TBI). It can occur as a result of either direct pituitary or indirect hypothalamic injury. Sports-related repetitive head trauma might induce pituitary dysfunction, and in particular, isolated GHD. Growth hormone replacement therapy (GHRT) has long been known to have a beneficial effect on body composition and exercise capacity. However, it has recently been shown that GHRT also benefits the brain. The primary objective of the current study is to assess the effect of GH on memory, executive function and attention domains of cognitive function in GHD- professional football players with TBI. The study will also utilize the adult growth hormone deficiency assessment (AGHDA) questionnaire, quantitative electroencephalogram (QEEG) and magnetic resonance imaging (MRI) techniques, respectively, to measure the quality of life (QoL), electrical activity and structural changes in the brain that may correspond to cognitive deficits.

Eligibility Criteria:
Inclusion Criteria:

* The subject is willing to provide a signed and dated informed consent indicating that he understands the purpose and procedures required for the study and is willing to participate in the study.
* Former NFL player
* At least one year since retirement from football
* Less than 76 years of age
* Diagnosis of GHD on clinical grounds by a neurologist and an endocrinologist GHD

Exclusion Criteria:

* History of pre-existing brain disease other than concussion or TBI
* History of a premorbid disabling condition that interferes with outcome assessments
* Contraindication to GH therapy
* Type I and II Diabetes mellitus
* Active malignant disease
* Acute critical illness, heart failure, or acute respiratory failure
* Subjects who are deficient in cortisol, testosterone or thyroid at screening will be excluded until hormone abnormalities have been corrected.
A Study of HY209 in Healthy Male Volunteers for Sepsis

A randomized, double-blind, placebo-controlled single dosing, dose escalation phase I clinical trial to investigate the safety/tolerability and pharmacokinetics of HY209 after intravenous administration in healthy male volunteers

HY209, which is being developed for the treatment of sepsis, inhibits inflammation by promoting the differentiation and division of Myeloid-derived suppressor cells (MDSCs).

Eligibility Criteria:
Inclusion Criteria:

* Healthy male aged from 19 to 45 at screening test
* BMI 18 kg/m2 \~ 27 kg/m2 at screening test
* Subjects found to be clinically healthy by medical history, physical examination, vital signs, electrocardiogram (ECG), and appropriate laboratory tests
* Those who must be capable of giving informed consent and willing to comply with all clinic visits and study-related procedures for the duration of study until study completion

Exclusion Criteria:

* Those who have a history of hypersensitivity or clinically significant hypersensitivity reactions to drugs (containing Taurodeoxycholate component, aspirin, antibiotics, etc.)
* Those who showed clinical symptoms suspected of acute infectious disease within 2 weeks before the first does, or whose body temperature (ear canal) measured at screening showed 38 ℃ or higher
* Those who have a clinically significant disease of liver, kidney, digestive, respiratory, endocrine, neurologic, blood/tumor, cardiovascular system history of those diseases
* Those who have a history of gastrointestinal diseases or surgery that may affect the absorption of the investigational drug
* Those who have a history of substance abuse or have tested positive for drugs of concern for misuse by urine drug screening
* Patients with the following blood pressure measured at the seat after resting for more than 5 minutes at the screening visit \[Systolic blood pressure (SBP): \< 90 mmHg or \> 150 mmHg, Diastolic blood pressure (DBP): \< 50 mmHg or \> 90 mmHg\]
* Those who participated in other clinical trials or bioequivalence within 6 months prior to the first dosing and received the drug
* Those who have donated whole blood within 2 months before the first dose or ingredient donation within 1 month or received blood transfusion within 1 month
* Those who have taken metabolic enzyme-induced and inhibitory drugs within 1 month before screening
* Those who consumed grapefruit / caffeine-containing foods within 3 days of the first dose and who cannot refrain from eating grapefruit-containing foods from 3 days before admission to discharge date
* Those who have taken specialty or herbal medicines within 2 weeks of the first dose or who have taken over-the-counter (OTC) within 1 week
* Caffeine overdose, alcohol overdose or oversmoker
* Those who have unusual eating habits or who are unable to eat the meals provided in this clinical trial
* Other investigator judged to be unsuitable as clinical subject
Acupuncture ACL (Anterior Cruciate Ligament)

Acupuncture research in regards to PONV has been fairly well established, however, studies about perioperative pain control and acupuncture are a little more murky. In 2008, a meta analysis looked at randomized controlled studies and found that while acupuncture was shown to decrease pain, there were limitations including credible placebo or sham intervention, and thus, blinding. The main purpose of this feasibility trial is to determine whether or not adequate blinding is possible in the intraoperative setting with the patient sedated.

According to the most recent survey conducted by the national center for complementary and integrative health (a branch of the National Institutes of Health) in 2007, the use of complementary alternative medicine (CAM) has increased significantly from 2002 (the previous survey). In the 2007 survey, in the United States alone, 38% percent of adults and 12% of children use some form of CAM. It has been 10 years since that survey report, there is little doubt that these numbers have only increased. According to the National Center for Health Statistics on the expenditures on CAM in 2012 - for just adults utilizing specialists, such as acupuncturists, $14.1 Billion was spent. With this increasing demand of such treatment modalities by patients, conventional practitioners will need to be, at the very least, well versed enough to recommend for or against these modalities. In addition, the current opioid epidemic is on the forefront of the public mind. Recently declared a public health emergency by the President, alternative means of postoperative pain control is a necessity and integrative medicine is a low cost, safe, and effective adjuvant/alternative

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing ACL Surgery with a participating surgeon
* English Speaking
* Patients at least 12 years old
* Planned spinal anesthesia without peripheral nerve block (rescue block is okay)

Exclusion Criteria:

* Patients under the age of 12
* Non-English speaking patients
* Patients planning on having general anesthesia
* Planned preop peripheral nerve block
* Patients with the inability to understand/follow study protocol
* Patients with pacemaker/AICD
* Non-native Ear/Previous scarring/surgical manipulation of ear
* Patients with contraindications to intra-op protocol
* Chronic pain patients
* Patients who have regularly used opioids for more than 6 weeks prior to surgery
* Patients with guages in their ears
* Patients who refuse to remove earrings/piercings prior to surgery
* Patients with nickel allergies (needles are made of nickel)