cyrilzakka/clinical-trials huggingface dataset:
Comparison of Midazolam or Dexmedetomidine on Epileptiform EEG During Sevoflurane Mask Induction

Induction with high sevoﬂurane concentrations may trigger epileptiform electroencephalographic activity without motor or cardiovascular manifestations in healthy patients. No other symptoms were associated in this series, and only electroencephalographic monitoring allowed the diagnosis. Midazolam and dexmedetomidine are sedatives commonly used in children before surgery. Although the mechanisms are different, both have been reported in antiepileptic effects.

This study was designed to compare the effects between intranasal midazolam or dexmedetomidine on epileptiform EEG during sevoflurane mask induction in children. Anaesthesia was induced with 8% sevoﬂurane. The patients were randomly assigned to Group A (n=15, preoperative intranasal normal saline), Group B (n=15, preoperative intranasal 0.25mg/kg midazolam), and Group C (n=15, preoperative intranasal 1μg/kg dexmedetomidine). An electroencephalogram was recorded before and during induction up to 10 min after the start of induction.


Eligibility Criteria:
Inclusion Criteria:

* ASA physical status 1-2
* Scheduled for general anesthesia

Exclusion Criteria:

* Patients with a history of neurological, mental illnes
* Patients with a history of congenital heart disease
* Patients with a history of allergies to related drugs
ADDERALL XR (Mixed Salts of a Single-entity Amphetamine) and STRATTERA ( Atomoxetine Hydrochloride) Compared to Placebo on Simulated Driving Safety and Performance and Cognitive Functioning in Adults With ADHD

Evaluate the efficacy of treatment with ADDERALL XR and STRATTERA compared to placebo on simulated driving safety and performance of young adults with ADHD as measured by Driving Safety Scores derived by the Driving Simulator.


Eligibility Criteria:
Inclusion Criteria:

* primary diagnosis of ADHD
* not naive to pharmacologic ADHD treatment
* valid driver's license with a minimum of 3 years driving experience

Exclusion Criteria:

* recent history of drug dependence or substance use disorder
* any specific cardiac condition that would, in the opinion of the investigator, require exclusion
* history of seizure in last 2 years, tic disorder or Tourette's disorder
* female subject is pregnant or lactating
Human Immunome Program

The Human Immunome Program is a large-scale, open-source effort seeking to fill a major gap in our knowledge of the immune system. The power of the immune system to fight disease lies in its ability recognize and adapt to an astonishing range of threats from viruses, parasites and bacteria to cancer cells. Underlying this ability is a vast but specific set of genes and molecular structures known as the human immunome, or the "parts list" of the immune system. This study aims to decipher the genetic sequences that make up this part list and link it to information about a person's microbiome composition and characteristics such as health history, race, and demographics over time. This information, made freely available to the public for use in research in de-identified form, will allow investigators to answer a wide variety of different questions about immune system function. This could transform how we diagnose, prevent and treat disease though the identification of new biomarkers while enabling highly targeted, computationally designed vaccines and therapies that reduce time and risk of product development.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female volunteers between the ages of 18 - 49 years of age at the time of first enrollment.
* Ability to comply: Participant willing and able to comply with the requirements of the protocol.
* Consent: Participants who have given informed consent for participation in the study

Exclusion Criteria:

Reason for exclusion throughout the entire study period:

* History of severe anemia requiring blood transfusion or current Hemoglobin \< 10g/dL.
* Currently pregnant or pregnancy within 6 months.
* Current participation in another study resulting in blood collection which exceeds 550 ml in an 8 week period or occurs more frequently than 2 times per week.
* Temperature \>101.4F
* Any condition which, in the opinion of the investigator, might interfere with study objectives.
* Any reason which, in the opinion of the investigator, adds additional risk to the patient.

Reason for exclusion in year 0 but not in year 1-9:

* History of known HIV infection or treatment.
* Immunosuppressive disease or use of systemic immunosuppressive therapy using drugs or cytotoxic agents including prednisone (IV, oral or inhaled) less than 6 months ago.
* History of diabetes mellitus -or a glucose (on CMP) ≥200 mg/dL.
* History of cancer including skin cancer.
* History of autoimmune disorders including but not limited to: Ulcerative colitis, Crohn's, Inflammatory Bowel Disease, Rheumatoid Arthritis, Scleroderma, Systemic lupus Erythematosus, Mixed Connective Tissue Disease, Graves, Autoimmune Thyroiditis, Hashimoto's Thyroiditis, Psoriasis, Multiple Sclerosis, Guillain-Barre Syndrome, Chronic Inflammatory demyelinating polyneuropathy, Myasthenia Gravis, Vasculitis, Alopecia areata, autoimmune hemolytic anemia, autoimmune hepatitis, dermatomyositis, idiopathic thrombocytopenic purpura, pemphigus, pernicious anemia, polyarteritis nodosa, polymyositis, Sjogren's Syndrome, Wegener's
* Severe obesity = (BMI \>40 kg/m2).
To Investigate the Efficacy and Safety of Individualized Doses of BioChaperone Insulin Lispro in Comparison to Humalog® U-100 in Patients With Type 1 Diabetes Mellitus

This is a double-blind, randomised, controlled, two period crossover phase Ib trial using an individualized standard meal with a fixed nutrient ratio in subjects with type 1 diabetes mellitus to investigate postprandial blood glucose control with BioChaperone insulin lispro compared to Humalog®. The assessments will be conducted before and after a period of multiple daily dose administrations for 14 days. The meal tolerance test will be performed on day 1-3 and on day 14 of each period. Furthermore the study aims at investigating Post-prandial glucose (PPG) profiles with BioChaperone insulin lispro and Humalog® when injected at various injection meal intervals (-15min, 0 minutes, +15 minutes).

Each subject will be randomised to a sequence of two treatments, either BioChaperone insulin lispro-Humalog® or Humalog®-Biochaperone insulin lispro, and three different sequences of injection-meal intervals. A blinded to patient continuous monitoring of glucose (CGM) will be performed during the 14 day treatment periods.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes mellitus (as diagnosed clinically) ≥ 12 months
* Treated with multiple daily insulin injections (no pump users) ≥ 12 months
* Current total daily insulin treatment \<1.2 (I)U/kg/day
* Body mass index (BMI) 18.5-28.0 kg/m² (both inclusive)
* HbA1c (N-(1-deoxy)-fructosyl-haemoglobin) ≤ 9.0% by local laboratory analysis
* Fasting C-peptide ≤ 0.30 nmol/L

Exclusion Criteria:

* Known or suspected hypersensitivity to trial products or related products
* Type 2 diabetes mellitus
* Patients using continuous subcutaneous insulin infusion (CSII)
* Previous participation in this trial. Participation is defined as randomised
* The receipt of any investigational product within 3 months prior to this trial
* Clinically significant abnormal haematology, biochemistry, lipids, or urinalysis screening tests, as judged by the Investigator considering the underlying disease
* Presence of clinically significant acute gastrointestinal symptoms (e.g. nausea, vomiting, heartburn or diarrhoea), as judged by the Investigator
* Known slowing of gastric emptying and or gastrointestinal surgery that in the opinion of the investigator might change gastrointestinal motility and food absorption
* Unusual meal habits and special diet requirements or unwillingness to eat the food provided in the trial
Optimization of the Nursing Time After the Use of Tissue Adhesives During the Chest Port Placement on Patients Treated With Chemotherapy Versus Sutures

Skin adhesive (Octyl cyanoacrylate - LIQUID BAND©) is increasingly used instead of suture for sutures on the superficial plane of the skin.

It is frequently used in children, in traumatology and in plastic surgery. Several randomized trials have shown satisfactory results of the glue compared to suture in terms of infections and scar dehiscence, and aesthetics after abdominoplasty and mammoplasty.

In the field of port-a-cath® placement in oncology:

* The use of skin adhesive can save substantial nursing time, which makes it possible to consider the transition of this technique into routine patient management. Potential benefits include nurses managing large numbers of patients in day hospitals, and patients no longer needing a nurse for suture removal.
* Cancer and chemotherapy toxicity can alter patients' body image and view of themselves. The presence of a scar can be traumatic for some patients. The second goal of this study is to test whether the use of glue can improve the appearance of the scar following port-a-cath® placement, an area in which there are divergent results.


Eligibility Criteria:
Inclusion Criteria:

* Patient with age ≥ 18 years
* Patient followed in day hospitalization in Oncology
* Patient requiring a first CP for chemotherapy
* Patient affiliated to a healthcare system
* French-speaking patient
* Patient who has given his free, informed and express oral consent

Exclusion Criteria:

* Patient followed in the Pneumology department
* Patient treated outside the GHPSJ
* Patient with a CP for another indication than chemotherapy (nutrition, antibiotic therapy)
* Patients with comprehension problems
* Patients with behavior issues
* Pregnant women
* Patients under guardianship or curatorship
* Patients deprived of liberty
* Patients under court protection
Physiotherapy Approach for Susac Syndrome

Susac's syndrome is a rare autoimmune disorder characterised by a triad of encephalopathy (brain dysfunction), branch retinal artery occlusion (loss of vision) and sensorineural hearing loss. This study presents the case of a patient undergoing intensive physiotherapy intervention following an injury, focusing on assessments such as volume and range of motion measurements, manual muscle tests, and pain intensity evaluations using various scales.

The patient, aged 17, initially presented with severe limitations in mobility, diagnosed with Susac syndrome. Requiring assistance to walk even short distances due to fear and insecurity. Through a structured physiotherapy program spanning several months, various assessments were conducted, including manual muscle tests and circumference measurements. Significant improvements were observed for muscle function, upper and lower limb circumferences, and performance in mobility tests.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of Susac syndrome.
* Willingness and ability to participate in a 12-week intensive physiotherapy program.
* Stable medical condition that allows participation in physiotherapy without significant risks.
* Ability to provide informed consent for participation in the study.

Exclusion Criteria:

* Presence of severe comorbidities or medical conditions that would interfere with participation in physiotherapy or confound the study outcomes.
* Inability to comprehend or follow the instructions for physiotherapy exercises.
* Pregnancy, as certain physiotherapy modalities may not be suitable during pregnancy.
* Any other condition or circumstance that, in the opinion of the investigator, would compromise the safety or validity of participation in the study.
Perioperative Goal Directed Therapy in Kidney Transplantation

In literature there is a huge amount of works demonstrating the direct correlation between volemic overload or fluid deficit and hypoperfusion and the increase in the rate of major postoperative complications in patients with high cardiovascular risk and chronic renal failure candidate to kidney transplantation from cadaver. It is also widely demonstrated that in certain populations with high surgical and post-operative complications risk, the adoption of targeted haemodynamic and clinical-therapeutic management protocols is indicated. The current trend is therefore to guarantee greater precision in the intraoperative management of patients undergoing kidney transplantation from cadaver by using a specific protocol that can be framed in the recent and innovative concept of Perioperative Gold Directed Therapy (PGDT), resulting from the adoption of an advanced minimally invasive hemodynamic monitoring technology with a special sensor called FloTrac (Edwards Lifesciences), already extensively tested in an extensive case series of high perioperative risk patients underwent to major abdominal surgery, major vascular surgery, major orthopedic surgery and cardio-thoracic surgery. In the present study there will be enrolled all patients who are candidates for kidney transplant from cadaver at the University Hospital "G. Rodolico" of Catania that meet the inclusion criteria of the study and will give their informed consent to participation. The enrolled patients will be monitored for a maximum period of 7 days from transplantation. As control group there will be considered an historical cohort of patients who underwent kidney transplantation from cadaver in 2015, in which a PGDT protocol was not used, but a common hemodynamic monitoring, based on parameters such as central venous pressure and / or invasive arterial pressure, was performed according to the international guidelines.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) Classification III-IV;
* Age between 18 and 65 years;
* First kidney transplantation from cadaver;
* Absence of atrial fibrillation or severe arrhythmia;
* Informed consent.

Exclusion Criteria:

* Lack of informed consent;
* Age less that 18 or greater than 65 years;
* Atrial fibrillation and high frequency tachyarrhythmias;
* Previous transplantation from cadaver.
Virtual Reality Exposure and Respiratory Relaxation-Based Coping With Cocaine Craving in Cocaine Users

Our study main objective is to test whether virtual reality exposure could elicit cocaine craving and its physiological arousal in cocaine users. Investigators aim to compare self-reported cocaine craving, self-efficacy to cope with craving and emotional states levels in 11 voluntary and adults cocaine users in 3 consecutive 10-mins conditions: Neutral VR (virtual reality exposure to neutral stimuli), Cocaine VR (virtual reality exposure to cocaine use-related stimuli) and Relaxation (respiratory relaxation).


Eligibility Criteria:
Inclusion Criteria:

- Cocaine use within the past 28 days

Exclusion Criteria:

* Actual manic or hypomanic episode (MINI, Lecrubier and al., 1998)
* Actual psychotic episode (MINI, Lecrubier and al., 1998)
* Actual high suicidal risk (MINI, Lecrubier and al., 1998)
* Being involved in incarceration procedure
* Medical risk for safety while physiological arousal (e.g. cardiac disease)
* Disability for performing virtual reality task (e.g. blindness or deafness)
* Significant motion sickness symptoms (SSQ pre-post total score ≥ 15, Bimberg et al., 2020)
Berodual® Respimat® Solution for Inhalation in Patients With Chronic Obstructive Airways Disease

Tolerability, efficacy and handling of Berodual® Respimat® 20/50µg/dose solution for inhalation in patients with chronic obstructive airways disease in daily practice


Eligibility Criteria:
Inclusion Criteria:

* Men and women presenting with symptoms of chronic obstructive pulmonary disease
* Both previously untreated patients and patients treated previously with Berodual® or with other anti-obstructive respiratory tract agents may be included

Exclusion Criteria:

* Patients presenting with the general and specific contraindications listed in the Patient Information Leaflet and the Basic Product Information
Efficacy of Fixed-doses of Antihypertensive and Statin Drugs

The purpose of this study is to evaluate the efficacy of different fixed-dose combination of Viena II in treatment of hypertension and dyslipidemia.

* Fase II, national, multicenter, randomized, double-blind.
* Maximal duration: 8 weeks;
* 04 visits;
* Safety and efficacy evaluation.

Eligibility Criteria:
Inclusion Criteria:

* Participants of both sexes aged between 18 and 65 years;
* Participants diagnosed with uncontrolled hypertension (stage 1), according VII Brazilian Guideline of Hypertension;
* Participants diagnosed with dyslipidemia, according to the V Brazilian Guidelines on Dyslipidemia and Prevention of Atherosclerosis;
* Signed consent.

Exclusion Criteria:

* Participants with a previous diagnosis of familial hypercholesterolemia (homozygous);
* Concomitant use of angiotensin II receptor blocker (ARB) or inhibitor of angiotensin converting enzyme (ACE);
* Participants with total cholesterol (TC) above 500 mg / dL or triglyceride (TG) above 500 mg / dL;
* Participants with hypertension (stage 2 or 3) according VII Brazilian Guideline of Hypertension;
* History of congestive heart failure (CHF) functional class III or IV (NYHA);;
* Any clinical, laboratory and electrocardiographic that, in the judgment of the investigator, may interfere with the safety of research participants;
* Creatine phosphokinase (CPK) levels above the established laboratory normal range;
* Transaminases (ALT and ASL) serum above 2 times the established laboratory normal range;
* Body mass index (BMI) ≥35 kg / m²;
* Immunocompromised participants (eg.: malignancies, patients with Acquired Immunodeficiency Syndrome etc);
* Chronic use of drugs that may interact with the drugs of the study;
* History hypersensitivity to the active ingredients used in the study;
* Pregnancy or risk of pregnancy and lactating patients;
* History of alcohol abuse or illicit drug use;
* Participation in clinical trial in the year prior to this study.
Confounding Factors in the Detection of Intracranial Hemorrhage With the Infrascanner

The investigators prospectively want to use the Infrascanner in patients with ischemic stroke, patients with brain surgery, patients with brain tumors, patients with intracranial hemorrhage and patients with a normal CT scan of the brain as part of a diagnostic work-up after head trauma or headache to determine to positive and negative predictive value of the Infrascanner in these different settings.

Infrascanner is a portable device initially designed to detect intracranial hemorrhage in battlefield traumas. Infrascanner uses near infrared spectroscopy to measure cerebral blood flow non-invasively. This is achieved by putting the device against the scalp in 4 different areas (frontal, temporal, parietal, occipital) on the left and right side and by comparing both sides.This allows for the detection of intracranial hemorrhages with a volume upwards of 3.5ml and to a depth of 2.5cm. However, little is known about the influence of other intracranial conditions that could confound the measurements of the Infrascanner (e.g. ischemic stroke, brain surgery, brain tumors,...).

Therefore, the investigators prospectively want to use the Infrascanner in patients with ischemic stroke, patients with brain surgery, patients with brain tumors, patients with intracranial hemorrhage and patients with a normal CT scan of the brain as part of a diagnostic work-up after head trauma or headache to determine the positive and negative predictive value of the Infrascanner in these different settings.

Eligibility Criteria:
Inclusion Criteria:

* Patients with ischemic stroke diagnosed by clinical examination and CT-scan
* Patients with a brain tumor diagnosed by clinical examination and CT-scan or MRI
* Patients with an intracranial hemorrhage diagnosed by clinical examination and CT-scan
* Patients that have undergone brain surgery
* Patients with a normal CT-scan of the brain after head trauma
* Patients with headache complaints and a normal CT-scan of the brain as part of their diagnostic work-up

Exclusion Criteria:

* none
Internet Administered CBT for Insomnia Comorbid With Chronic Pain

Cognitive behavioural therapy (CBT), that is designed to be short, concise and user friendly is compared to applied relaxation techniques as treatment for insomnia comorbid with chronic pain. Both treatments are administered via internet and participants are randomized to ether treatment arm.

Internet treatment with therapist support means that measurements are collected through the Internet. Participants are recruited from a specialized pain clinic for chronic pain. All patients with sleep complaints (Insomnia Severity Index \> 14) at their first visit through 2016-01-01 to 2017-07-31 are asked for participation via mail. Volunteers sign informed consent and undergo a online screening. If matching the inclusion criteria, they are contacted for a telephone interview. Subjects are assessed according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criterion for insomnia disorder, M.I.N.I. (screening for psychiatric comorbidity) and the other inclusion/exclusion criteria. The treatment, that is designed to be short, concise and user friendly as it is meant to be usable as an adjunct treatment to other main interventions for chronic pain. The treatment lasts for five weeks and focuses on the most potent CBT technics for insomnia; sleep restriction and stimulus control.

Randomization is conducted by university staff not otherwise involved in this study. Participants have equal chance to be allocated to ether CBT or applied relaxation techniques (active controls). The relaxation treatment lasts for the same amount of time (five weeks) and is designed to require similar weekly effort. Both groups fill in sleep diaries every week and weekly feedback is provided by master students supervised by clinical psychologists.

The overall hypothesis is that CBT leads to greater symptom reduction (according to the Insomnia Severity Index) compared to applied relaxation techniques.

Eligibility Criteria:
Inclusion Criteria:

* Insomnia severity index (ISI) score \> 14
* Chronic pain

Exclusion Criteria:

* Shift worker or employed as a driver, operator of dangerous equipment and such
* Sleep apnea, restless legs syndrome, narcolepsy, Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)
* Bipolar disorder, psychotic disorders, ongoing substance abuse
* Having received CBT for insomnia during the latest year
* Pregnancy
* Severe somatic disorder (such as ongoing cancer, severe neurological condition, insufficiently treated cardiac condition)
* Impaired movement to such a degree that going to bed or getting out of bed requires assistance
* Not being able read or wright in Swedish
* Not having an internet-connected computer, cellular phone or tablet