cyrilzakka/clinical-trials huggingface dataset:
Aminotransferase Trends During Prolonged Acetaminophen Dosing

The objective of this study is to monitor liver function tests (blood levels of an indicator of liver function) of healthy people taking the maximum labeled daily dose of acetaminophen compared to people taking placebo for 16 to 40 days. Those people that continue to have normal liver tests after 16 days will have completed their part of the study. People that develop abnormal liver function tests will continue taking acetaminophen or placebo, and have their liver tests monitored closely for up to an additional 24 days. This is to (1) make sure these tests return to normal and (2) determine when these tests return to normal while still taking acetaminophen or placebo. If at any time the liver tests indicate anything more than a minor increase, you would be immediately told to stop taking the study drug.

Secondary objective is to determine the proportion of subjects that have detectable acetaminophen-protein adducts after daily dosing.

Acetaminophen use is common and many consumers take 4g/day for longer than 4 days. The use of 4g/day of acetaminophen for more than 4 days causes an asymptomatic ALT elevation in some people. This elevation most likely resolves while continuing treatment, but it is possible that some individuals may go on to develop clinical liver injury. By carefully following healthy subjects who are taking the maximal daily dose of acetaminophen, we can safely determine if the ALT elevation resolves or progresses to clinical liver injury. If a subject develops clinical liver injury we can intervene before irreversible injury occurs.

Eligibility Criteria:
Inclusion Criteria:

* age 18 or older

Exclusion Criteria:

1. History of acetaminophen ingestion on any of the four days preceding study enrollment
2. Measurable serum acetaminophen level at time of enrollment
3. Viral markers of Hepatitis B or C, or viral markers of Hepatitis A with an ALT level greater than ULN during screening laboratory testing
4. Serum ALT or AST level greater than ULN at Screening or Day 0
5. Total bilirubin level greater than ULN at Screening or Day 0
6. INR level greater than ULN at Screening
7. Alkaline phosphatase level greater than ULN at Screening
8. Platelet count less than 125 10\^9/L at Screening
9. Known cholelithiasis
10. Positive pregnancy test at Screening (female participants only)
11. History of consuming more than an average of 3 alcohol containing drinks daily over the preceding 2 weeks
12. History of consuming 3 or more alcohol containing drinks on any given day during the 2 weeks prior to study enrollment
13. New prescription medication started within the previous 30 days
14. Currently taking isoniazid
15. Currently taking warfarin
16. Currently adheres to a fasting type diet as determined by self report
17. Currently has anorexia nervosa as determined by self report
18. Participant is clinically intoxicated, psychiatrically impaired or unable to give informed consent for any reason
19. Known hypersensitivity or allergy to acetaminophen
Comparison of Corneal Stromal Tissue Consumption (LATAC)

In refractive surgery, stromal ablation depth is fundamental because it determines the thickness of the residual posterior wall. The posterior wall is an essential element that guarantees the refractive stability and the long term prevention of corneal ectasia after corneal refractive surgery. A minimum thickness of more or less 300 microns is universally accepted. Its calculation is based on well-known formulas, such as Munnerlynn ones.

With the excimer laser platform last generation WaveLight® Allegretto® EX-500 of Alcon, a new treatment option called "wavefront optimized" is offered for myopia, astigmatism and hyperopia. The ablation profile has been developed to save stromal tissue consumption and to favor the quality of vision, by optimizing connections between the optical zone and the transition zone of the photoablation. Alongside the theoretical formulas, evaluation of the depth of ablation may be defined by differential ultrasonic pachymetry or by topographical analysis pre and postoperatively. The latter is currently the method of reference to assess the corneal thickness.


Eligibility Criteria:
Inclusion Criteria:

* Patients having a refractive disorder and for whom a refractive surgery is programmed.

Exclusion Criteria:

* Patient opposed to participation in the study
* Another refractive surgery technique
* Hyperopic patient
* Pregnant or lactating woman
* Patient under a measure of legal protection
* Absence of affiliation to social security or universal health coverage (CMU)
Influence of Atorvastatin on Psoriasis Severity and Endothelial Function

Patients with psoriasis seem to have increased risk for developing atherosclerosis. This may be due to the fact that psoriasis and atherosclerosis are both caused by inflammation and involvement of cells of the immune system. Atherosclerosis is frequently treated by statins (class of cholesterol lowering drugs), which lower bad cholesterol levels and also reduce inflammation. Some new evidences also suggest that therapy with statins may improve psoriasis skin disease.

The current study aims are to evaluate whether a strong statin named Atorvastatin can improve psoriatic skin disease and functioning of the arteries. The study also aims to evaluate if the activity of these two diseases are related to levels of common inflammatory biomarkers (substance in blood) and whether Atorvastatin can change their levels.


Eligibility Criteria:
Inclusion Criteria:

* Patients older than 20 years
* Patients with psoriasis of at least 3-years duration
* Current moderate to severe psoriatic disease (PASI ≥12, IGA≥3)
* Statin-naïve patients
* No history of cardiovascular disease (ischemic heart disease, peripheral vascular disease or cerebrovascular disease)
* LDL levels

  * LDL level \> 70 mg% and \< 160 mg% in low risk patients (defined as having none or a single risk factor\*)
  * LDL \> 70 mg% and \< 130 mg% in moderate risk patients (defined as the presence of 2 or more risk factors\*)
  * LDL \> 70 mg% and \< 100 mg% in patients with type II diabetes
* hsCRP ≥ 1 mg/l \* Risk factors: smoking, hypertension (blood pressure \> 140/90 or current treatment with blood pressure lowering agents, HDL \< 40 mg%, family history of premature coronary artery disease in a first degree relative younger than 45 (men) or 55 (women) and obesity (BMI ≥ 30).

Exclusion Criteria:

* Current statin therapy
* Patents with Atrial Fibrillation
* Elevated liver enzymes (\> X3 ULN)
* History of statin-induced liver enzyme elevation
* Elevated CPK levels (\> X3 ULN)
* History of myopathy including statin-induced
* Severe chronic renal failure (GFR \<30 ml/min)
* Pregnant or breast-feeding women
* Individuals at risk for poor protocol, or medication compliance
* Patients with life-expectancy of less than 2 years
* Patients who are currently participating in another clinical trial
* Other current active inflammatory and/or infectious conditions
* Sensitivity to any of atorvastatin ingredients
* Concomitant drug therapy, taken on a regular basis, which may interact with Atorvastatin
Bioavailability Study of Psilocybin in Normal Adults

The purpose of this research study is to compare an oral dose of psilocybin and an intravenous (IV) infusion of psilocybin to assess differences in how the drug is absorbed by the body, the psychedelic experience, and any side effects when taken by healthy adult participants. Participants can expect to be in the study for approximately 12 weeks.

Psilocybin, when delivered to screened and prepared participants in a controlled environment, has shown strong evidence of positive effects in treating cancer-related psychiatric distress, depression and anxiety, treatment-resistant depression, and nicotine or alcohol addiction. Psilocybin therapy is generally safe and well-tolerated when conducted under controlled conditions. Psilocybin is very rapidly transformed to the active metabolite psilocin, which is considered the active agent from psilocybin administration. Oral and IV psilocybin are expected to have similar pharmacokinetic and psychedelic effects, as well as safety profiles, while IV psilocybin will achieve more consistent blood levels than are possible with oral psilocybin.

Eligibility Criteria:
Inclusion Criteria:

* Overall healthy and medically stable, as determined by screening
* Capable of giving signed informed consent
* Negative urine pregnancy test in persons of childbearing potential

Exclusion Criteria:

* Have any of the following cardiovascular conditions: uncontrolled hypertension, coronary artery disease, congenital long QT syndrome, cardiac hypertrophy, cardiac ischemia, congestive heart failure, prior myocardial infarction, tachycardia, artificial heart valve, corrected QT interval (QTc) \>450 msec at screening, any other clinically significant screening ECG abnormality, or any other significant cardiovascular condition
* Presence of a gastrointestinal disease that could interfere with absorption of an orally administered drug
* Have epilepsy
* Positive urine drug test
* Prior adverse effects from psilocybin or other psychedelics that required hospitalization
* Currently taking on a regular basis (e.g., daily) any medications having a primary centrally acting serotonergic effect, including selective serotonin reuptake inhibitors (SSRIs), monoamine oxidase inhibitors (MAOIs), or serotonin-acting dietary supplements (such as 5-hydroxy-tryptophan or St. John's wort)
* Currently taking prohibited medications, including antihypertensive medications, UGT1A9 or 1A10 inhibitors (e.g., regorafenib, rifampicin, phenytoin, eltrombopag, mefenamic acid, diflunisal, niflumic acid, sorafenib, isavuconazole, deferasiroxor, ginseng), and aldehyde or alcohol dehydrogenase inhibitors (e.g,, disulfiram)
* Participation in another concurrent clinical study; or use of investigational drugs, biologics, or devices within 30 days prior to assignment of study drug administration order
* Anyone who is pregnant, lactating, or planning on becoming pregnant during the study
* Unwilling to withhold prohibited concomitant medications
The Effect of Deep Versus Moderate Muscle Relaxants in Men During and After Robotic Surgery for Prostate Cancer

The purpose of this study is to determine if there is a difference in intra-abdominal pressure which surgeons use during surgery and post-surgery pain in men who undergo robotic prostate surgery with deep neuromuscular blockade (NMB), compared with moderate NMB.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients under the age of 80
* American Society of Anesthesiologists Physical Status 1, 2, 3.
* Elective Robotic Prostatectomy
* Patient undergoing surgery at Josie Robertson Surgical Center

Exclusion Criteria:

* Age younger than 18
* Inability to provide informed consent
* Allergy to rocuronium, sugammadex, midazolam, propofol, fentanyl, lidocaine, mannitol (IV Acetaeminophen), IV Acetaminophen, Ketorolac, Morphine, Hydromorphone, Dexamethasone, Zofran, Benadryl, Compazine
* Neuromuscular disease
* Any patient with previous abdominal surgery less than or equal to 20 years prior to scheduled surgery date
* Patients with BMI\>35
* Severe renal impairment (Creatinine clearance \< 30 ml/min)
* Patient receiving Toremifene or any history of receiving Toremifene
* Chronic pain patients
* Patients receiving suboxone
* Patients receiving succinylcholine
Differentiate AVNRT from Orthodromic AVRT

To study new maneuvers to differentiate AVNRT from orthodromic AVRT including VA interval variability at tachycardia induction, SA-VA base and local VA index (difference between local VA interval, measured on the coronary sinus catheter during tachycardia and entrainment, at the site of earliest atrial activity).

The differentiation of atrioventricular nodal reentrant tachycardia (AVNRT) from atrioventricular reciprocating tachycardia (AVRT) as well as the localization of accessory pathways (APs) is necessary to guide the catheter ablation of supraventricular tachycardia (SVT). However, existing techniques may prove challenging in differentiating atypical forms of AVNRT from AVRT using a septal AP; or localizing AVRT with different septal AP insertion sites.

There are many diagnostic maneuvers during electrophysiological study eg ventriculo atrial interval (VA) during tachycardia, postpacing interval tachycardia cycle length (PPI-TCL) and stimulus atrial ventriculaoatrial interval (SA-VA). It is important to recognize that as with most diagnostic tests, no single observation or maneuver is 100% sensitive or specific. Therefore, it is important to obtain data from multiple observations and maneuvers to verify the diagnosis.

Also, utility of these techniques usually depends on the tachycardia to be sustained, however sometimes tachycardia is rapidly terminating. VA interval at initiation of tachycardia is usually variable and becomes fixed after several beats. This may be explained by differences in retrograde conduction between AVRT and AVNRT which may be better exposed at the time of tachycardia induction, So measuring the number of beats until VA becomes fixed may theoretically help in differentiating AVNRT from AVRT.

Although several reports have demonstrated the usefulness of the SA-VA using right ventricular (RV) apical stimulation (SA-VAapex) to distinguish AVNRT from AVRT, there remains significant overlap in the SA-VA complicating the distinction between these 2 arrhythmias.

Theoretically, stimulation from the RV basal septum (SA-VAbase) would be expected to shorten the SA interval in AVRT because atrioventricular pathways insert in the ventricular base. On the other hand, the SA-VAbase should have the opposite effect on AVNRT because the impulse must first pass from the RV base to the apex to access the right bundle.

Eligibility Criteria:
Inclusion Criteria:

* All patients with documented narrow complex supraventricular tachycardia presented to electrophysiology lab including all age and sex patients (in Assiut university cath. lab) and proved to be AVNRT or orthodromic AVRT.

Exclusion Criteria:

1. Atrial tachycardia
2. Atrial flutter.
3. Atrial fibrillation.
4. Manifest preexcitation on surface ECG -
Comparison of Hyalomatrix and Integra Wound Matrix on Burn Wounds

The purpose of this randomized, comparative study is to determine whether Hyalomatrix is as effective as IntegraTM Meshed Bilayer Wound Matrix when used in subjects who receive concurrent treatments with both products on their first and/or second degree burns located on both hands.


Eligibility Criteria:
Inclusion Criteria:

* Written consent must be obtained
* First and/or second degree burns on both hands
* Subject must be enrolled within 48 hours of the injury occurrence.

Exclusion Criteria:

* Subject is breastfeeding, pregnant, or has intentions of becoming pregnant during the course of their study participation.
* Subject has a prognosis that indicates unlikely survival past the study period.
* Subject's diagnosis indicates third degree burns.
* Subject suffers from burns sustained as a result of an electrical/chemical injury or by frostbite.
* Subject suffers from any inhalation-related burn trauma.
* Subject suffers from ongoing bone fractures.
* Subject has a known sensitivity to materials containing silicone, hyaluronan, bovine collagen, or chondroitin and/or derivatives of these products.
* Subject has received any treatment prior to study enrollment that may, in the opinion of the Investigator, affect the outcome of the study.
* Subject suffers from a medical condition that may impede wound healing, above any beyond that which would typically be expected.
Drug Risk Aversion Calculator Use to Facilitate MS Patient Self-efficacy

The investigators seek to determine if the use of a Side Effect Aversion Calculator helps patients with multiple sclerosis (MS) more comfortably and rapidly identify the disease modifying drug (DMD) that is best suited for the patient.

Settling into the use of a multiple sclerosis disease modifying drug (DMD) can seem like taking an important final examination, consisting of a single multiple choice question with 16 equally appropriate responses, having months or even years to second-guess your choice, and then getting a grade but never being told the correct answer.

Making the choice between these options can be overwhelming, leaving patients feeling both disempowered and depersonalized in the decision-making process.

In order to allow a better, more personalized, decision-making process the investigators introduce a side effect aversion calculator, which takes a patient's individual side effect aversion profile into consideration when discussing the start of a new disease modifier (initial drug, or drug switch). Subjects will be multiple sclerosis patients who have a provider-identified need for DMD initiation or DMD switch and receive their care at Duke. Recruitment goal is 100 subjects. Those randomized to "calculator arms" will be reminded that the purpose of the calculator is to facilitate the DMD choice discussion, NOT make the decision. Subjects asked to rate level of concern over adverse events (AEs) across all DMDs. Calculator multiplies subject response by the prevalence reported within DMD prescribing information. Sum of these weighted scores reveals a DMD's Total Aversion score and medication ranking by patient's specific side effect aversion profile, therefore framing discussion. Enrollment visit concludes with survey designed to collect MS clinical history, MS symptoms, medication history, medication adherence and self-efficacy. This same survey is conducted prior to subsequent three clinic visits.

Eligibility Criteria:
Inclusion Criteria:

* Be at least 18 years old
* Be able to read and speak English
* Be currently treated or starting treatment with an MS disease modifying medication

Exclusion Criteria:

* All of the inclusion criteria must be met. If they cannot be met, then they are excluded from the study
Non-Myeloablative Allogeneic Transplantation From Unrelated Donors in Multiple Myeloma

The protocol aims at reducing transplant toxicity and mortality in patients with multiple myeloma.

Primary end points are engraftment and non-relapse mortality. Secondary end points are disease response, overall survival, progression and event free survivals. Patient eligibility criteria.

Inclusion criteria included:

* Diagnosis of Durie-Salmon stage IIA-IIIB multiple myeloma
* Age \> 18 and ≤ 65 years at the start of the donor search
* Presence of concurrent co-morbidities precluding myeloablative conditioning or refusal to undergo a conventional allogeneic transplant
* Capacity to give informed consent

Exclusion criteria included:

* Age \> 65 years
* Karnofsky performance status score \< 60%
* Progressive disease or stable disease for less than three months
* Central nervous system (CNS) involvement
* Left ventricular ejection fraction \< 35% or symptomatic heart failure
* Poorly controlled hypertension
* Pulmonary dysfunction with diffusing capacity for carbon monoxide (DLCO) \< 40% and/or need for continuous oxygen supplementation
* Abnormal liver disease with a serum bilirubin greater than twice normal or SGOT and/or SGPT greater than four times the upper limits of normal
* HIV positive patients
* Pregnancy
* Refusal to use contraceptive techniques during and for 12 months following treatment

Informed consent is obtained during study registration from each patient according to the Institutional Review Boards of the participating centers. The study is conducted according to the Declaration of Helsinki.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Durie-Salmon stage IIA-IIIB multiple myeloma
* Age \> 18 and ≤ 65 years at the start of the donor search
* Presence of concurrent co-morbidities precluding myeloablative conditioning or refusal to undergo a conventional allogeneic transplant
* Capacity to give informed consent

Exclusion Criteria:

* Age \> 65 years
* Karnofsky performance status score \< 60%
* Progressive disease or stable disease for less than three months
* Central nervous system involvement
* Left ventricular ejection fraction \< 35% or symptomatic heart failure
* Poorly controlled hypertension
* Pulmonary dysfunction with diffusing capacity for carbon monoxide (DLCO) \< 40% and/or need for continuous oxygen supplementation
* Abnormal liver disease with a serum bilirubin greater than twice normal or SGOT and/or SGPT greater than four times the upper limits of normal
* HIV positive patients
* Pregnancy
* Refusal to use contraceptive techniques during and for 12 months following treatment
Ultrasound for Confirmation of Gastric Tube Placement in Critically Ill Patients Under Invasive Mechanical Ventilation

Introduction: Data using ultrasonography to confirm correct position of the gastric tube is heterogeneous in approach sites, combination exams, and methodology.

Aim: Find the best strategy to confirm gastric tube placement to avoid immediate complication.

Method: A randomized controlled trial was initiated to compare ultrasonography and standard routine method, using non-inferiority design. The study will be conducted in one medical ICU with 59 beds at a medical center. The primary outcome is the correct rate as comparing with the chest radiography in each group. Total 190 patients is needed with estimated 10% drop-out rate.


Eligibility Criteria:
Inclusion Criteria:

* Clinical indication of nasogastric tube placement
* Age than 20 years old.

Exclusion criteria:

* Facial trauma or head-base fractures
* Esophageal or gastric resection
* Esophageal strictures or alkaline injury
* Open wound in the area to prevent ultrasonography
Modified Periostal Pocket Flap Technique

The aim of this study is to propose a modification of the original periostal pocket flap technique consisting in replacing the xenograft by a conglomerate which contains autologous bone obtained from the future implant site through biological drilling technique and PRGF (Plasma Rich in Growth Factors)

Materials and methods: 8 patients referred for implant placement and with a slight bucco-lingual (BL) width deficiency in alveolar bone were included in the study. Patients were placed dental implants and bone width was augmented by using the conglomerate mentioned above.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a favorable bone density and favorable bone length but insufficient bone width that could compromise implant placement

Exclusion Criteria:

* Smokers (\>10 cigarettes per day) and patients with severe systemic disease ( ASA III or IV - American Society of Anaesthesiology)