cyrilzakka/clinical-trials huggingface dataset:
Oral vs IV Acetaminophen for Long-bone Fracture in Children

Intravenous (IV) acetaminophen entered the Canadian market recently and children with acute pain following a trauma are ideal candidates for the IV formulation as it may improve analgesia and consequently decrease the amount of opioids needed to achieve pain control. Due to the limited data on bioavailability, adverse effect profile and efficacy of IV versus oral acetaminophen, it is of paramount importance to generate evidence-based data to guide clinicians with a rational choice of route of administration of acetaminophen.

Therefore, we propose a pilot study to inform a future large randomized controlled trial (RCT) to compare pharmacokinetics, feasibility, preliminary effects and side effects profile of oral versus IV acetaminophen in children admitted for surgical fixation of a long-bone fracture.

Patients admitted for a long-bone fracture needing surgical fixation are generally initially treated with intranasal and/or IV opioids in association to oral acetaminophen and ibuprofen. Following surgery they are treated with a combination of morphine and acetaminophen. To address the issue of opioid epidemics, the Pediatric Orthopaedic Society of North America recommends reduction of their prescription as much as possible by promoting, among others, use of multimodal analgesia after surgery. The current proposal aims to improve post-operative pain control in children following a surgical fixation of a long-bone fracture and decrease the use of opioids through better co-analgesia. As such, this study aims to assess the pharmacokinetics (PK) and the efficacy of oral versus IV formulations of acetaminophen after surgery for long bone fractures in children.

Eligibility Criteria:
Inclusion Criteria:

* Likely to undergo surgery for a long-bone fracture
* Aged between 2-18 years (IV acetaminophen is approved for children ≥2 years)
* IV line per standard of care

Exclusion Criteria:

* Contraindication to oral drug administration
* Patients unable to take oral solution
* Known hypersensitivity or allergy to acetaminophen or any of the excipients in the IV or oral formulation
* Use of any medication known to interact with acetaminophen including, but not restricted to phenytoin and carbamazepine (1)
* Pregnancy
* Known Hepatic insufficiency or hepatic disease
* Known or diagnosed severe renal failure
* Multiple trauma (more than two long bone fractures)
* Hemodynamic or respiratory compromise
* Altered level of consciousness (Glasgow coma scale \<15)
Pharmacokinetic Study in Patients Receiving Posaconazole Therapy in Taiwan

The purpose of this study is to investigate the factors influencing pharmacokinetic and pharmacodynamic properties of new antifungal agent, posaconazole in Taiwanese patients.

Invasive fungal infection (IFI) may cause high mortality and morbidity in immune- compromised patients. Posaconazole, a new triazole antifungal agent with broad spectrum coverage, was approved for both treatment and prophylaxis of IFIs. Previous studies have demonstrated the relationship between posaconazole plasma concentration and efficacy, thus, the importance of posaconazole therapeutic drug monitoring (TDM) was gradually accepted. However, studies found inter- and intra-individual variation between concentrations, and these phenomenons were affected greatly by GI function, food intake and concomitant medication. Furthermore, there's a lack of posaconazole TDM study in Asian population.

The study was designed to describe the prescribing pattern of posaconazole, to study the relationship between concentration and clinical outcomes/ adverse events, to identify factors that influence plasma concentration, and to evaluate whether routine TDM is needed in our institution.

Eligibility Criteria:
Inclusion Criteria:

* Patients receiving posaconazole therapy
* Patients aged 13 years old or more

Exclusion Criteria:

* No posaconazole plasma concentration available
Association of the Neutrophil/Lymphocyte Ratio With Pulmonary Complications and Mortality in COVID-19 Patients

The Coronavirus Disease-19 (COVID-19) pandemic is currently a priority for health services worldwide. Unlike the Severe Acute Respiratory Syndrome-Coronavirus (SARS-CoV) epidemic in 2012, the COVID-19 shows specific alterations in the white blood cell count, accentuated in severe cases, and with respiratory failure. Among the most relevant data are both lymphopenia, thrombocytopenia, and eosinopenia. The Neutrophil Lymphocyte Index has been beneficial in the evaluation of infectious respiratory processes, showing a sensitivity similar to scales such as CURB65 (Confusion, Uremia, Respiratory rate, BP, age ≥ 65 years). Because COVID-19 infection shows alterations in the blood cell ratio, these indices may be useful in evaluating patients with COVID-19 infection.

The hematological alterations in patients with COVID-19 divided into two aspects: the main ones, the global leukocyte count, and the individual counts. Most of the information about the behavior of blood counts come from cases attended in Wuhan, China. At the Zhongnan Hospital in Hubei Province, identified that the lymphocyte count was lower in critically ill patients. At the same time, the leukocyte counts were higher in deaths associated with COVID-19, this elevation being mainly of neutrophils. The lymphopenia is also a constant data in COVID-19 (47.4%), especially in cases that entered the Intensive Care Unit. As in community pneumonia, severe lymphopenia has associated with a high risk of death. A relationship between neutrophils and lymphocytes is called the Neutrophil-Lymphocyte index. This index is especially useful for predicting respiratory complications, such as for COVID-19, where mortality ranges from 2-9% compared to the 2012 epidemic (10%) or Middle East Respiratory Syndrome (37%). In Mexico, there is a high prevalence of chronic diseases that increase the risk of COVID-19 infection. This study's main objective is to identify the association of blood abnormalities on respiratory complications associated with COVID-19 infection. All data were obtained from the clinical records of patients treated by COVID-19.

Eligibility Criteria:
Inclusion Criteria:

* Patients with active COVID-19 infection

Exclusion Criteria:

* Liver failure
* Active cancer
* Chronic renal failure
* AIDS
* Pregnancy
Evaluation of Infarct Size With 3D Rotational Angiography

The size of the infarct is particularly important prognostic marker. It is clearly established that the extent of the infarct is not only correlated to mortality, but also long-term adverse events. The evaluation of the infarct size at the acute phase of the disease is therefore an essential clinical tool to adapt the immediate treatment and follow-up of patients. It is therefore crucial to have techniques that are effective, precise, reproducible, and easily performed during the acute phase to quantify the size of the infarct following angioplasty. Myocardial scintigraphy and cardiac MRI have been the standard examinations for the evaluation of infarct size. However, these exams are difficult to perform during the acute phase of the infarct owing to difficulties in monitoring unstable patients and the limited availability of the apparatus. It is for this reason that the investigators would like to investigate the rotational angiography (RA), which is comparable to a scanner in its mode of action but does not require transfer of patients as performed using the same apparatus that used for diagnostic coronarography and therapeutic angioplasty. RA is a radiological technique that uses the system employed for coronagraph, and consists rotating the fixed C-Arm around the patient and acquisition of a series of images that are then reconstituted. The investigators propose to evaluate the size of the infarct using RA in comparison with cardiac MRI (standard examination) performed as soon as possible after RA and the investigators hope to demonstrated that RA allows the measurement of an infarct as precisely as cardiac MRI.


Eligibility Criteria:
Inclusion Criteria:

* Admitted for myocardial infarction and fulfilling the following criteria:

  * Transitory or persistent ST elevation
  * Coronary occlusion (TIMI 0) treated by angioplasty or thrombotic acute stenosis treated or not by angioplasty
* Planned coronarography
* With social security coverage
* Not under any legal protection;
* The consent form signed.

Exclusion Criteria:

* Patient unconscious or confused;
* Presenting:

  * cardiogenic shock;
  * or signs of cardiac insufficiency;
  * or sustained cardiac arrhythmia;
  * or atrial fibrillation;
  * or sustained extrasystole;
  * or high degree block;
* Contraindication for MRI;
* Known history of hypersensitivity to MRI contrast agent;
* Risk of pregnancy or proven pregnancy based on interview data;
* Breast feeding;
* Patient subject to legal guardianship by a court;
* Incapacity to express consent;
* Patient not or badly understanding French.
Phase III rhu_GM-CSF + 3 Induction Regimens in Adults With Acute Non-Lymphocytic Leukemia

Phase III Study of Priming with Granulocyte-Macrophage Colony Stimulating Factor (rhu-GM-CSF) and ofThree Induction Regimens in Adult Patients (Over 55) with Acute Non-Lymphocytic Leukemia


Eligibility Criteria:
Inclusion Criteria:

* All patients with acute non-lymphocytic leukemia are eligible for the study.

Exclusion Criteria:

* N/A
Intra-subject Variability Following Administrations of Activated Recombinant Human Factor VII in Haemophilia Patients in a Non-bleeding State

This trial is conducted in Asia and Europe. The aim of this trial is to evaluate the intra-subject variability of thromboelastographic parameters (TEG® and ROTEM®) following two administrations of activated recombinant human factor VII in haemophilia patients in a non bleeding state.

The TEG® parameters are: R time (Reaction Time), K time (K Time (arbitrary measurement)), a (a angle), MA (Maximum Amplitude) and LY30 (Lysis 30 min after MA) while the ROTEM® parameters are: CT (Clotting Time), CFT (Clot Formation Time), a (a angle), MCF (Maximum Clot Firmness) and LI60 (Lysis index 60 min after CT).


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of congenital haemophilia A or B with a FVIII:C (Activated Coagulation Factor VIIa Clotting activity) or FIX:C (Coagulation Factor IX Clotting activity) one stage activity, respectively, at less than 5% of normal (based on medical records) plus/minus inhibitors (a positive inhibitor status defined as 0.6 Bethesda units)
* Non-bleeding state (i.e. no clinical manifestation of active bleed) at the time of administration of trial product

Exclusion Criteria:

* Known or suspected allergy to trial product or any of its components or to related products
* Known clinically relevant coagulation disorders or insufficiencies other than congenital haemophilia A or B
* Platelet count below 50,000 platelets/mcL
* Received any haemostatic treatment (e.g. Feiba) within the last 7 days prior to administration of trial product, except for activated recombinant human factor VII
Efficacy of Wharton Jelly in Erectile Dysfunction

Efficacy of Intracavernous injection of Wharton jelly Mesenchymal stem cells for the treatment of erectile dysfunction in diabetic patients.

This study will be conducted at the Cell Therapy Center (CTC), Jordan, in which 22 male patients ranging from 25-70 years diagnosed with erectile dysfunction will be selected. This diagnosis is based on medical history, validated questionnaires, physical examinations, laboratory tests and specific diagnostic tests.

The patients are followed by clinical assessment, laboratory investigations as well as Doppler ultrasound.

The investigators hypothesize that the intracavernous injection of stem cells will facilitate the recovery of erectile function resulting in satisfying clinical outcomes in patients.

Eligibility Criteria:
Inclusion Criteria:

1. Adult male patients ranging from 25 to 70 years.
2. History of chronic erectile dysfunction for at least six months.
3. Baseline international index of erectile function (IIEF) score of \< 26.
4. Not interested or able to use phosphodiesterase type 5 inhibitor (PD5i) drug therapy and willing to forgo theses treatments for the first 6 month period following study treatment.
5. Body Mass Index between 20-30.
6. Willing to provide written informed consent, complete questionnaire, and to be available for all baseline treatment and follow up examinations required by protocol.

Exclusion Criteria:

1. Current urinary tract or bladder infection.
2. Clinical/Laboratory evidence of transmissible diseases.
3. Clinically evident penile anatomical deformities(e.g., Peyronie's disease) or history of priapism.
4. Skin irritation, infection, wound, sore or disruption in the immediate areas of skin entry for penile injection.
5. Current or previous malignancy.
6. Use of any non study treatment for erectile function within 4 weeks of study treatment.
7. Lack of willingness to continue through 6 months after study treatment.
8. Any previous penile implant or penile vascular surgery.
9. Uncontrolled hypertension or hypotension(systolic blood pressure \> 170 or \< 90 mm Hg, and diastolic blood pressure \> 100 or \< 50 mm Hg).
10. Reported unstable cardiovascular disease (e.g., unstable angina, myocardial infarction within past 6 months, cardiac failure or life-threatening arrhythmia, congestive heart failure) or symptomatic postural hypotension within 6 months before screening.
11. Bleeding or clotting disorder, use of anticoagulant therapy.
12. Lab values for complete blood count (CBC), prothrombin time (PT)/ partial thromboplastin time (PTT)/ international normalized ratio (INR), alanine aminotransferase (ALT), aspartate aminotransferase (AST) and creatinine falling outside the normal lab values.
13. Systemic autoimmune disorder.
14. Significant active systemic or localized infection.
15. Receiving immunosuppressant medications.
16. Post-radical prostatectomy.
Safety and Efficacy Study of ATGC-100 for the Treatment of Moderate to Severe Glabellar Lines in Adult Subjects

Phase I/II clinical trial will be integrated and conducted. In phase I clinical trial, subjects with moderate to severe glabellar lines at maximum frown are enrolled and safety is assessed after 12 weeks of administration of 20U of ATGC-100. In phase II clinical trial, subjects with moderate to severe glabellar lines at maximum frown are enrolled, and efficacy and safety are assessed by comparing with Botox (Allergan).


Eligibility Criteria:
Inclusion Criteria:

1. Healthy males and females aged between 19 to 65 years old
2. Subjects attaining ≥ grade 2 in the investigator's rating of the severity of glabellar line at maximum frown
3. Subjects who voluntarily signed the informed consent

Exclusion Criteria:

1. Subjects with general neuromuscular synaptic disorders
2. Presence or history of eyelid and/or ptosis
3. Subjects with noticeable facial asymmetry
4. Inability to substantially lessen glabellar frown lines even by physically spreading apart
5. Subjects who have administered the following drugs within 4 weeks prior to screening: Muscle relaxants, Anti-cholinergic agents, Benzodiazepine and similar drugs, Benzamide drugs, Tetracycline antibiotics, Lincomycin antibiotics, Aminoglycoside antibiotics
6. Subjects who are taking Anti-Coagulant and Anti-Platelet agent
7. Subjects who have taken Aspirin and NSAIDs within 7 days prior to administration of investigational drug
8. Subjects with skin disorders at the injection site
9. Subjects with previous treatment of Face Lifting, Permanent Implant, and/or Filler in glabellar region
10. Subjects with prior filler treatments which would have interfered with the evaluation of the efficacy of the study treatment
11. Any other planned facial aesthetic procedure in the glabellar area during the trial period
12. Previous treatment with botulinum toxin in the forehead within the last 5 months or any planned treatment during the study period
13. A history of drug or alcohol abuse
14. Condition including anxiety disorder, or any other significant psychiatric disorder (e.g. depression), in the investigator's opinion
Visual and Electromyography Assessments in Response to Train-of-Four Stimulation of the Ulnar Nerve

Researchers are comparing the accuracy of measuring muscle relaxation during and after surgery with a device that provides numeric value versus visual observation to count of muscle twitches or absence of them by a medical provider monitoring your anesthesia during surgery.


Eligibility Criteria:
Inclusion Criteria:

* Age \> or = 18 years old
* Patients willing to participate and provide an informed consent
* Patients undergoing an elective surgical procedure that requires use of NMBA agents administered intraoperatively.

Exclusion Criteria:

* Patients with disorders, such as stroke, carpal tunnel syndrome, broken wrist with nerve damage, Dupuytren contracture, or any similar wrist injury.
* Patients with systemic neuromuscular diseases such as myasthenia gravis
* Patients with significant organ dysfunction that can significantly affect pharmacokinetics of neuromuscular blocking and reversal agents, i.e., severe renal impairment or end-stage liver disease.
* Patients having surgery that would involve prepping the arm or leg into the sterile field
Cellular microRNA Signatures in Multiple Sclerosis

A limited number of studies on microRNA expression variation in immune cells have been reported in relapsing-remitting multiple sclerosis (RRMS). These studies have been performed mostly on a small scale and on whole blood mononuclear cells (PBMC).

In a number of cases, RRMS progresses to a severe secondary neurodegenerative form. In this context, it is important to look for biomarkers that could indicate the pathogenic activity of certain immune cell subpopulations.

SEP-MIR is a prospective, single-center, descriptive study.

Participants will be recruited among adult patients with RRMS coming for a follow-up consultation in the Neurology Department, Nervous System Diseases Pole, at the hôpital Pitié - Salpêtrière (Paris).

As this is a descriptive study, the recruitment of 20 participants (10 patients with relapsing-remitting MS and 10 patients with relapsing-remitting MS) should meet the objectives of this study.

A 50 ml blood sample will be obtained from each participant and several clinical data regarding their pathology will be collected.

Eligibility Criteria:
Inclusion Criteria:

* Caucasian population
* Female and male individuals with an f/m ratio of 2-4/1
* Individuals with RRMS according to the 2010 McDonald criteria for less than 15 years, with EDSS 1-6, in remission or relapse
* Participant's condition compatible with a maximum of 50 ml of blood collection
* Persons affiliated with a social security plan.

Exclusion Criteria:

* MS treatment with steroidal anti-inflammatory drugs, immunomodulators or immunosuppressants within 2 months prior to blood collection
* Persons with acute and chronic infectious disease, autoimmune/inflammatory disease or cancer other than MS
* Pregnant or lactating women
* Be under guardianship,
* Be deprived of liberty by judicial or administrative decision, or be under legal protection.
Endoscopic Ultrasound-Guided Fiducial Placement for Stereotactic Body Radiotherapy

The purpose of this research study is to evaluate placing the radiation therapy markers (Fiducial) by using an endoscopic procedure. The endoscopic procedure is called an Endoscopic Ultrasound (EUS). This is a procedure using a special endoscope that has an ultrasound on the end. The ultrasound will allow the doctor's to see where the radiation therapy markers (Fiducial) is to be placed as outlined by the Radiation Oncologist.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older,
* Scheduled to undergo fiducial placement,
* Subject must be able to give informed consent

Exclusion Criteria:

* Any contraindication to performing endoscopy,
* Participation in another research protocol that could interfere or influence the outcomes measures of the present study,
* The subject is unable/unwilling to give informed consent
To Compare Ridge Preservation Technique Using Leukocyte Platelet Rich Fibrin (L-PRF) and Freeze-dried Bone Allograft (FDBA) Layered Technique vs L-PRF/FDBA and L-PRF Alone in Influencing Quantity and Quality of New Bone Formation in Grafted Extraction Sockets

This study will evaluate the effect of Leukocyte Platelet Rich Fibrin and freeze-dried bone allograft in a layered technique on the bone quantity and quality following socket grafting in preparation for endosseous implant placement.

Pre (baseline)- and post-grafting (3 months) clinical as well as 2- and 3-dimensional radiographic measurements will be used to evaluate the dimensional ridge changes between sites grafted with L-PRF/FDBA layered technique vs. L-PRF/FDBA and L-PRF alone.

Histological analysis will be performed by a bone biopsy taken at time of surgical re-entry (after 3 months) of grafted sites to place the dental implant and assessed for differences in new bone formation between the three types of graft.

This study is a prospective, three-arm randomized trial that will evaluate and compare the bone healing following ridge preservation of extraction sockets using either L-PRF/FDBA layered technique or L-PRF/FDBA or L-PRF alone in a total of 30 patients (10 in each arm).

Qualifying participants and defects will be randomized following a computerized permutation block to receive either technique on day of surgery. Tooth extraction will be performed with a flapless minimally invasive technique, followed by socket grafting with a randomized graft.

The mineralized cortico-cancellous bone allograft that will be used in this study will be obtained from the same donor, lot and tissue bank to account for variation in age, race, gender and related healing potential of different graft sources.

Bone core biopsies will be harvested at time of implant placement 3 months following socket grafting. Bone cores will then undergo histological and histomorphometrical analyses to determine qualitative and quantitative healing differences between three treatment groups.

Clinical measurements are gathered at 2 time points (grating and implant placement) at all defects and will be compared for differences.

Cone beam computed tomography (CBCT) initial scans are conducted immediately following socket grafting and second scans obtained prior to implant placement. Virtual implant planning software will be utilized to assess and compare the 2- and 3-dimensional changes for all defects.

Eligibility Criteria:
Inclusion Criteria:

* English speaking and able to read and understand English informed consent document
* At least 18 years old.
* Must be a patient at the UAB School of Dentistry
* Patient is willing and able to comply with all steps of the study
* Hopeless single-rooted tooth planned to be replaced with a dental implant and with healthy adjacent teeth not planned for extraction.

Exclusion Criteria:

* Patients with systemic pathologies or conditions contraindicating oral surgical procedures or adversely affecting wound healing
* Pregnant women
* Patient is a poor compliance risk (i.e., poor oral hygiene, history of alcohol or drug abuse)