cyrilzakka/clinical-trials huggingface dataset:
The Efficacy of L-Carnitine in the Management of Acute Carbon Monoxide Poisoning

Carbon monoxide (CO) poisoning results in high morbidity and mortality worldwide. CO is described as a "silent killer" because CO is colorless, odorless, and tasteless but highly toxic. The diagnosis of acute CO poisoning depends on the history of exposure to a source of fire in a closed space along with the clinical and laboratory findings.

The pathophysiology of CO poisoning is not fully understood; however, it is proved that CO induces hypoxia by forming carboxyhemoglobin (COHb) and shifting the oxygen dissociation curve to the left. The molecular mechanisms of CO poisoning include oxidative injury through the generation of free radicals. In addition, oxygen therapy might enhance the reactive oxygen species (ROS) production and result in reperfusion injury. Free radicals could induce a serious impact on vital organs, including the heart, and brain.

L-Carnitine is an endogenous mitochondrial constituent that contributes to normal mitochondrial activities. L-Carnitine is an antioxidant with potent ROS scavenging ability. ROS-mediated pathology of CO suggests that antioxidants are potentially useful agents in the alleviation of CO toxicity. Thus, the current study will investigate the therapeutic efficacy of L-Carnitine in improving the prognosis of acute CO poisoning.

The current clinical trial will include patients with moderate and severe acute carbon monoxide poisoning according to Poisoning Severity Score.

A randomized clinical trial (phase II) will be conducted at Alexandria Main University Hospital.

The total required sample size is 72. The sample size was calculated by G power 3.1.9.4 software program depending on the primary outcome. According to these assumptions: Effect size, defined as the difference between group 1 and group 2 in the mean troponin levels at 24 hr, was calculated according to Sun et al. (2011) and was 0.657, alpha error =0.05, power of 80%, allocation ratio 1:1. A 20% expected attrition was added to the sample size to account for loss to follow-up. So, the final sample size was 72; 36 patients per group.

All patients will be subject to the following:

1. History taking:

   * Personal data: age, and sex.
   * Exposure-related data: circumstances of exposure, and time till hospitalization.
   * Past medical history.
2. Clinical assessment:

   * Glasgow coma scale, vital signs, and general examination.
   * Laboratory investigations: arterial blood gases (ABG), Carboxy hemoglobin level (COHb), and cardiac enzymes (CPK, CK-MB, Troponin).
   * Electrocardiogram (ECG).

Eligibility Criteria:
Inclusion Criteria:

* The current clinical trials will include patients with moderate and severe acute carbon monoxide poisoning according to Poisoning Severity Score.

Exclusion Criteria:

* When the diagnosis of acute carbon monoxide poisoning is unconfirmed.
* Patients with advanced cardiac and neurological diseases.
Ultrathin DES in Complex PCI Scenarios: the ULTRA a Multicenter Study

ULTRA is a multicenter, observational, retrospective registry, enrolling consecutive patients treated with ultrathin coronary DES (coronary stent with strut thickness \< 70 um) for coronary bifurcation lesions, left main disease, chronic total coronary occlusion, and in-stent restenosis regardless of their clinical presentation. Target lesion failure (TLF a composite endpoint of cardiovascular death, target vessel myocardial infarction, target lesion revascularization and definite stent thrombosis) will be the primary end point, while its single components will be the secondary ones along with all-cause death, all acute myocardial infarction (excluding peri-procedural AMI), target vessel revascularization and BARC major bleedings (BARC 3-5). Due to the retrospective, observational nature of the registry, no formal sample size estimation is required. Patients complying with detailed inclusion criteria and with a minimum follow up of 6 months will be enrolled.


Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years old
* Unprotected left main stenosis
* Bifurcation coronary stenosis (with side branch diameter ≥ 2.5 mm)
* Chronic total coronary occlusion
* In-stent restenosis

Treated with the following devices:

* Orsiro
* Mistent
* BioMime
* Supraflex Cruz

Exclusion Criteria:

* patients died during the index revascularization procedure
Evaluation of the National Treatment Program of Hepatitis C in Egypt

The aim of the study is to analyse data coming from two treatment centres of the National Treatment Program Centres of hepatitis C in Egypt

Analyse data coming from two centres of the National Treatment Program of hepatitis C in Egypt:

* 1500 patients who started treatment between April 1st 2013 and March 31st 2014 and will be seen for their week 60 visit between July 1st 2014 and June 30th 2015 (Cohort A).
* 1000 patients recruited between July 1st 2014 and estimated March 31st 2015, of which 200 are expected to be early defaulters and will be contacted by the study team (Cohort B).

Eligibility Criteria:
Inclusion Criteria:

* Age \< 18 years and \> 60 years
* Positive HCV antibodies using a third generation test
* Detectable HCV RNA by PCR
* Liver biopsy showing chronic hepatitis with either a METAVIR score F1 with elevated liver enzymes or scores F2/F3
* Naïve to treatment with PEG-IFN and RBV
* HBs antigen negative
* Prothrombin time ≥60 %, normal bilirubin, alpha-foeto protein \< 3\*normal range of the laboratory, anti-nuclear antibodies\<1/160
* Effective contraception during the treatment period; no breast-feeding
* Signed informed consent and willingness to participate in the study

Exclusion Criteria:

* Serious co-morbid conditions such as severe hypertension, heart failure, significant coronary heart disease, poorly controlled diabetes (HbA1C\>8%) , chronic obstructive pulmonary disease
* Major uncontrolled depressive illness
* Solid transplant organ (renal, heart, or lung)
* Untreated thyroid disease
* History of previous anti-HCV therapy
* Body mass index (BMI) greater than 30 kg/m²
* Known human immunodeficiency virus (HIV) coinfection: although HIV testing will not be proposed or done, patients with known HIV coinfection will not be included in the trial
* hypersensitivity to one of the two drugs (PEG-IFN, RBV)
* pregnancy or unwilling to comply with adequate contraception
* breast-feeding
* neutropenia (\<1500/mm3)
* anaemia (\<11g/dL for women ; \<12g/dL for men)
* thrombocytopenia (\<100.000/mm3)
* elevated creatinin (\>1.5mg/dL)
* concomitant liver disease other than hepatitis C (immuno-active chronic hepatitis B, autoimmune hepatitis, alcoholic liver disease, hemochromatosis, alpha-1 antitrypsin deficiency, Wilson disease)
* liver biopsy showing severe steatosis (\>66%) and steatohepatitis; decompensated cirrhosis (Child Pugh\>A); hepatocellular carcinoma, METAVIR score F4.
* TSH\>5 mU/L
REsponse to Combined SONS and ONS in Chronic Cluster HeadachE

The purpose of this study is to demonstrate the safe use of the PRIMUS System in subjects with chronic cluster headache. This is a single-centre, open label, prospective, first in human study to collect initial clinical data on the PRIMUS system for the treatment of chronic cluster headache.


Eligibility Criteria:
Main Inclusion Criteria:

* Able and willing to provide informed consent
* Documented chronic cluster headache for at least 1 year as per ICHD-3 criteria
* Attack frequency of ≥ 4 attacks per week for ≥ 4 weeks before enrolment
* Documented failure of verapamil (failure meaning ineffective, provoked unacceptable side-effects or contra-indicated)
* Stable on preventive treatment for at least two weeks prior to enrolment.
* Agree to refrain from starting new prophylactic cluster headache medication or other preventive treatments, from 4 weeks before entering the baseline period throughout the duration of the study
* MRI available (not older than 4 years prior to study enrolment) or willing to undergo an MRI to exclude structural lesions potentially causing headache
* Able and willing to complete a headache Diary

Main Exclusion Criteria:

* Any other chronic primary or secondary headache disorder, unless they can clearly differentiate them from cluster headache attacks based on the quality and associated symptoms
* Concomitant neuromodulation, except tVNS
* Previous failure to any implantable neuromodulation device for neurovascular headache
* Have an existing Active Implantable Medical Device nearby the implant location (e.g. DBS, cochlear implant, ...)
* Metal implants in the skull (e.g. skull plates, seeds) nearby the implant
* Have a pacemaker or implantable cardioverter defibrillator (ICD)
* Suboccipital infiltrations with steroids and/or local anaesthetics or use of oral steroids in the past 3 months
* Use of botulinum toxin injections in the past 12 weeks
* Calcitonin gene-related peptide inhibitors started less than 12 weeks prior to enrolment
* Women of childbearing age who are pregnant, nursing or not using contraception
Randomized Clinical Trial of Posterior Retroperitoneoscopic Adrenalectomy Versus Lateral Laparoscopic Adrenalectomy

Laparoscopic adrenalectomy has become the gold standard operation for non-malignant adrenal tumors replacing open adrenalectomy. The most popular lateral transperitoneal laparoscopic adrenalectomy (LTLA) approach has been recently challenged by an increasing popularity of the posterior retroperitoneoscopic adrenalectomy (PRA) approach which is believed by many surgeons as an easy to learn, reproducible and beneficial for patients. However, this belief is not evidence-based, so far. The aim of this study is to clarify if PRA is superior to the LTLA as minimally invasive approach to small and benign adrenal tumors.

Laparoscopic adrenalectomy has replaced open adrenalectomy as the standard operation for non-malignant adrenal tumours. Thanks to the popularization of the posterior technique described by Walz and co-workers, the posterior retroperitoneal adrenalectomy (PRA) is being performed in increasing numbers worldwide. Advocates for the laparoscopic and retroperitoneoscopic approaches cite the advantages of each technique, but there is no published evidence that supports the superiority of one over the other. Most of the published literature is retrospective, with inadequate or no controls and with potential biases.

The aim of this study is to test the hypothesis that PRA is superior to the lateral transperitoneal laparoscopic adrenalectomy (LTLA) as minimally invasive approach to small and benign adrenal tumors.

For a sample size calculation an assumption was made that a 20% reduction in duration of surgery represents clinically relevant difference. To detect this, it was calculated that 24 patients would be required in each treatment arm to give the study a power of 90 per cent. Anticipating a 25% loss to follow-up, 32 patients per arm were required in the study.

Eligibility Criteria:
Inclusion Criteria:

* unilateral adrenal tumor below 7cm in diameter without suspicion for malignancy

Exclusion Criteria:

* active malignancy
* pregnancy or lactation
* age below 18 years, or above 80 years
* high-risk patients according to the American Society of Anesthesiology (ASA 4 grade or higher
* inability to comply with the scheduled follow-up protocol
Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis (INTEGUMENT-II)

This study will assess the safety and efficacy of ARQ-151 cream vs vehicle applied once a day for 4 weeks by subjects with atopic dermatitis (eczema). This is a parallel group, double blind, vehicle-controlled study in which ARQ-151 0.15% cream or vehicle is applied once daily (qd) for 4 weeks by participants with atopic dermatitis.


Eligibility Criteria:
Inclusion Criteria:

1. Participants legally competent to sign and give informed consent and, if appropriate, assent as required by local laws.
2. Males and females, ages 6 years and older at time of signing Informed Consent (Screening). Only subjects 18 years and older will be enrolled at sites located in the province of Québec in Canada.
3. Diagnosed with atopic dermatitis 6 months duration (3 months for children), as determined by the Investigator. Stable disease for the past 4 weeks with no significant flares in atopic dermatitis before screening.
4. Females of childbearing potential (FOCBP) must have a negative serum pregnancy test at Screening and a negative urine pregnancy test at Baseline/Day 1. In addition, sexually active FOCBP must agree to use at least one form of a highly effective or barrier method of contraception throughout the trial.
5. In good health as judged by the Investigator.
6. Subjects considered reliable and capable of adhering to the Protocol and visit schedule, according to the judgment of the Investigator.

Exclusion Criteria:

1. Subjects with any serious medical condition or clinically significant abnormality that would prevent study participation or place the subject at significant risk, as judged by the Investigator
2. Has unstable AD or any consistent requirement for high potency topical steroids.
3. Subjects who are unwilling to refrain from prolonged sun exposure and from using a tanning bed or other artificial light emitting devices (LEDs) for 4 weeks prior to Baseline/Day 1 and during the study.
4. Females who are pregnant, wishing to become pregnant during the study, or are breast-feeding.
5. Previous treatment with ARQ-151.
6. Subjects with a history of chronic alcohol or drug abuse within 6 months prior to Screening.
7. Parent(s)/legal guardian(s) who are unable to communicate, read, or understand the local language(s). Subjects who are unable to communicate, read or understand the local language, or who display another condition, which in the Investigator's opinion, makes them unsuitable for clinical study participation.
8. Subjects who are family members of the clinical study site, clinical study staff, or sponsor, or family members of enrolled subjects living in the same house.
Is There an Ideal Dose of Intravenous Fentanyl in the Prehospital Setting

In a previous study the investigators evaluated the apparent efficacy and safety of intravenous fentanyl administered by ambulance personnel and found that 58.4% (CI 56.4-60.4) out of 2348 prehospital patients treated with fentanyl still experienced moderate to severe pain \[numeric rating scale (NRS, 0-10) \> 3\] at hospital arrival. The number of patients with possible fentanyl-related side effects was low.

Therefore, the aim of the present study is to explore the efficacy and safety of a liberalized pain treatment protocol for ambulance personnel (a total of 3 μg/kg per transport) compared with existing restrictive protocol (a total of 2 μg/kg per transport). The investigators hypothesize that:

* A higher proportion of patients will experience sufficient pain relief at hospital admission (NRS \< 4) using the liberalized protocol and
* There will be no differences in the proportion of potential fentanyl related side-effects are observed.

A prospective cluster-randomized trial observing proportional differences in sufficient pain relief at hospital admission (NRS \< 4) and potential fentanyl related side-effects between patients treated by ambulance personnel applying either:

* a more liberal treatment approach (a total of 3 μg/kg per transport) or
* existing treatment approach (a total of 2 μg/kg per transport).

The Ambulance stations and their affiliated ambulance personnel are stratified into 5 clusters according to size/average transports per month and randomized to either liberal or existing treatment approach within each cluster. As patients are not randomized on an individual level baseline differences between the two groups and its patients are adjusted statistically with relevant confounders on 3 overall levels:

1. Patients: Charlson Comorbidity Index Score, main overall diagnose category, inhospital surrogate measures of disease severity (intensive care unit admission and 30-day mortality).
2. Ambulance personnel: Years of experience and preinterventional cumulative fentanyl administration and
3. Ambulance stations and geographical factors: prehospital time measures and geographical distance from site of emergency to hospital.

These covariates are obtained from the Danish National Patient Registry, the Danish Civil Registration System and the electronic prehospital patient journal.

Eligibility Criteria:
Inclusion Criteria:

* Patients with acute pain treated with intravenous fentanyl by ambulance personnel

Exclusion Criteria:

* Reduced conscious level (GCS \< 15) before initiation of fentanyl treatment
* Reduced respiratory rate (\< 10/minute) before initiation of fentanyl treatment
* Patient weight \< 30 kg
* Known opioid allergy
* Women in labour
* Chronic pain conditions
Animal-Assisted Therapy in Pediatric Autism Spectrum Disorders

The purpose of this research is to evaluate the effect of animal-assisted therapy (AAT) on prosocial behavior and emotional regulation in children with developmental delay, behavioral concerns, or autism spectrum disorder. Service dog use in the pediatric population who have these concerns is increasing and more studies are indicated to determine best practice for incorporating canines into traditional therapy sessions to enhance therapeutic outcomes. The hypothesis for this study is that inclusion of the canine will enhance therapy sessions and produce a lasting effect on prosocial behavior and emotional regulation after AAT sessions have concluded.

Investigators are determining if a child's verbality affects interaction with the canine or changes the effect of animal-assisted therapy on prosocial behavior and emotional regulation in autistic children.

Eligibility Criteria:
Inclusion Criteria:

* Referred to the program for ASD diagnostic evaluation based on their development and behavior. Could have ASD, developmental delay, or behavioral concerns.

Exclusion Criteria:

* Afraid or allergic to canines
Current Practice of Patients Undergoing C-arm Procedures at the Operating Department

All x-ray systems at the MUMC+ are currently operated by radiodiagnostic technicians. This is also the case for C-arms used during surgical procedures at the OR-complex. Because a gain in time efficiency is expected (i.e. not for research related reasons), a group of OR-personnel will be in-house trained to qualify for operating C-arms in low complex procedures. The shift towards C-arm procedures performed by OR personnel has been initiated also in other hospitals as it is expected to be time saving without loss of quality. However, this is an assumption and not proven by any scientific evidence. Several aspects are interesting for scientific studies as little is known about the effects of this shift on image quality, radiation dose, time efficiency and to guarantee that there is no loss of quality for the patient.

This study investigates the standard care, where radiodiagnostic technician operate the C-arms.

This study is set up such that it can serve as a baseline for a future study in which it will be assessed whether the quality of care when OR-personnel operates the C-arms is non-inferior to the standard care.

The aim of the study is to prospectively assess the standard care.

Research questions are twofold:

1. What is the current practice and current time efficiency of C-arm procedures performed by radiodiagnostic technicians?
2. What is the current quality of C-arm procedures operated by radiodiagnostic technicians?


Eligibility Criteria:
Inclusion Criteria:

* All C-arm OR-procedures performed at the OR-complex of the MUMC+;
* Type of procedure is: low complex: extremities (upper or lower), high complex: lower extremities, spinal cord (four procedure types).

Exclusion Criteria:

* No informed consent;
* Incomplete procedure information and technical parameters;
* Withdrawal of informed consent by the study patient.
Evaluating Outcomes in the Placement of Boomerang Percutaneous Device

The purpose of this study is to evaluate the safety and effectiveness of the Boomerang percutaneous closure device following diagnostic cerebral angiography or neurointerventional procedures.

Background:

Very few publications have evaluated this relatively novel percutaneous closure device.

The purpose of this study is to document our experiences using the Boomerang closure device. Several different closure devices are used in the department of Radiology. A closure device is something that is placed in the artery in the leg just prior to removing the catheters from your leg at the end of the imaging or treatment procedure that is to be performed in the Department of Radiology. The devices used are all FDA approved. This study will compare the Boomerang device (a newer FDA approved device) to the other older devices currently being used. You may not have the Boomerang device used in your procedure; however, the Boomerang device is used in almost all of our patients undergoing a neuro imaging or treatment procedure. The neuroradiologist will determine which device if any is best for you based on the size of your artery, your medical condition etc. We will only collect data about you and your procedure if the Boomerang device is used.

Eligibility Criteria:
Inclusion Criteria:

* Any patient that has a percutaneous Boomerang closure device placed after having a neuro-intervention

Exclusion Criteria:

* Patients that do not have this medical device used post procedure
Secondary Central Nervous System Lymphoma Registry - Charité

The objective of the observation is to collect and document data on treatment strategies for secondary central nervous system lymphoma (SCNSL) in routine clinical practice, whether obtained in the context of clinical trials or outside of trials. In particular, the following questions will be specified:

* What therapeutic approaches are being pursued?
* What is the clinical outcome of the various treatment options?
* What is the frequency of serious adverse events with each therapeutic approach?

The observational study is to be conducted in inpatient clinics, outpatient clinics and by oncology physicians in private practice. The investigators will be invited to participate by the Charité - CNS Lymphoma Working Group (Charité AG ZNSL) or the Competence Network Malignant Lymphomas (KML). When a patient is reported, the personal data of the physician including the patient will be recorded and compiled in the form of a list documentation.

All patients with SCNSL can and should be included in the study regardless of which therapy options are used and regardless of whether it is a first-line treatment, the treatment of a recurrence or a maintenance therapy for SCNSL. No intervention is associated with the conduct of the observational study with regard to the selection and implementation of the specific therapeutic regimen, diagnostics, and examination frequency during and after treatment.

The following information should be documented:

* Patient demographics and medical history
* Tumor extent at the time of initial diagnosis and CNS involvement
* Prior therapy
* General condition
* Therapy regimen for the CNS involvement
* Response
* Adverse drug reactions
* Tolerability of therapy: acute toxicity
* Chronic therapy toxicity, especially late neurotoxicity
* Time to treatment failure (relapse or progression)
* Death from any cause

Eligibility Criteria:
Inclusion Criteria:

• All patients with SCNSL can and should be included in the registry regardless of which treatment options are used and whether the treatment being given is first-line, recurrence, or maintenance therapy for SCNSL.

Exclusion Criteria:

• None