cyrilzakka/clinical-trials huggingface dataset:
End Tidal Anesthetic Concentration in Different Anesthesia Techniques Where Depth of Anesthesia Adjusted With Entropy

The aim of this study is to adjust the end tidal inhalation anesthetic concentration by observing the entropy value in patients who will be provided anesthesia maintenance with volatile anesthetics after applying the routine epidural anesthesia technique and to observe the end tidal volatile concentration that will provide to remain in the target entropy limits during the operation.

The hypothesis of this study is that in general anesthesia cases which is combined with thoracic epidural anesthesia (TEA), lower alveolar concentration will be required to reach the same anesthesia depth. The main aim of the study is observing and comparing the alveolar concentrations of anesthetic agents with entropy monitoring which is an anesthesia depth monitor in major abdominal surgeries where general anesthesia is combined or not with TEA.

In cases where TEA is combined with general anesthesia or not, anesthesia depth will be effectively monitored by entropy monitoring, in this way the adequate depth of anesthesia will be provided with the use of minimal volatile anesthetics and we will be able to prevent the use of large amounts of volatile anesthetics., It will be determined how much reduction in alveolar concentration is required in cases combined with TEA.

Nowadays, with the development of reliable anesthesia machines, "low-flow anesthesia" (LFA) is becoming more widespread, and its benefits on patient health, economy and ecology have been demonstrated. In LFA, the depth of anesthesia should not be too superficial or too deep during the time the alveolar concentration of volatile agent reaches equilibrium. Therefore, alveolar concentrations of volatile anesthetics are monitored in modern anesthesia machines. Some machines may also adjust the depth of anesthesia according to the alveolar concentration of the agent.

Eligibility Criteria:
Inclusion Criteria:

* undergoing major abdominal surgery
* Patients who will not undergoing operation for thoracic cavity
* Body Mass Index (BMI) between 20-30

Exclusion Criteria:

* denial of patients
* contraindications for thoracic epidural anesthesia
* patients who are FEV1/FVC \< 60
* patients with thoracic and lomber vertebrae surgery
Cannabis for Spasticity in Multiple Sclerosis

The purpose of this study is to learn if the use of inhaled cannabis (marijuana) and oral cannabinoid (dronabinol, Marinol or THC, which is an active ingredient of marijuana) is safe and effective in reducing the symptoms of spasticity and tremor in patients with secondary-progressive or primary progressive multiple sclerosis.

The treatment of MS is far from satisfactory. For acute attacks, high dose corticosteroids seem to reduce the duration of attacks and to reduce the likelihood of future attacks. Immunomodulatory agents, available in this disease over the last decade, reduce the frequency of severe attacks by about one third. The remainder of the treatments are symptomatic, aimed at reducing the disability already present.

Recent research into the CB1 and CB2 cannabinoid receptor systems suggest that cannabis may have the potential for affecting both the pathogenic mechanisms and the symptoms of MS. In light of the autoimmune hypothesis of the etiology of MS, THC could directly alter immune function in a manner that might reduce (or increase) the primary pathology of the disease.

Comparisons: Three treatment arms will be compared: 1) inhaled cannabis and oral placebo, 2) inhaled placebo and oral THC, 3) inhaled placebo and oral placebo, with the effects of these agents analyzed at thirty and sixty days.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of clinically definite multiple sclerosis as defined by Poser criteria
* Primary or secondary disease course
* Moderate or severe spasticity
* Age 21 or older

Exclusion Criteria:

* Preexisting pulmonary conditions, including poorly controlled asthma, chronic bronchitis, emphysema, bronchiectasis, and other significant pulmonary disorders
* Preexisting cardiac conditions, including ischemic heart disease, congestive heart failure, and other significant cardiac disorders
* Inability to abstain from tobacco or marijuana smoking, or use of alcohol or sedative or hypnotic medications during the duration of the study
* Past history of abuse of recreational drugs, including marijuana and alcohol in the last 12 months
* History of or currently meets DSM-IV criteria for dependence on cannabis
* Use of cannabis, marijuana, or THC in the last two weeks
* Preexisting dementia, mania, depression, or schizophrenia or other poorly controlled psychiatric illness
* Exacerbation of MS within 30 days prior to screenin visit
* Current use of cyclophosphamide, mitoxanthrone, or cladribine
* Arthritis, bony and soft tissue disorders interfering with spasticity measures
* Inability to provide informed consent
* Recent cannabis use of more than twice per week one month prior to study entry
Prognostic Value of Angio-IMR in Hypertrophic Cardiomyopathy Patients

Coronary microvascular dysfunction (CMD) is among pathophysiological states of significance in hypertrophic cardiomyopathy (HCM). The index of microcirculatory resistance (IMR) has been recognized as an indicator of CMD and considered of important prognostic value in various conditions. The angiography-derived index of microcirculatory resistance (angio-IMR) is a novel guidewire-free method to assess IMR and proved to have favourable correlation with it. This study was designed to assess prognostic impact of CMD in HCM patients, using angio-IMR as a novel non-invasive assessment tool.

Coronary microvascular dysfunction (CMD) is among pathophysiological states of significance in hypertrophic cardiomyopathy (HCM). The index of microcirculatory resistance (IMR) has been recognized as an indicator of CMD and considered of important prognostic value in various conditions. The angiography-derived index of microcirculatory resistance (angio-IMR) is a novel guidewire-free method to assess IMR and proved to have favourable correlation with it. In this study, patients who met the inclusion criteria were collected from two centers, and the angio-IMR of three coronary arteries was measured to monitor their microcirculation. Then, explore the prognostic value of the angio-IMR of the left anterior descending artery (LAD). At the same time combined with the sum of three coronary arteries' angio-IMR, analysis of its prognostic value. In conclusion, this study was designed to assess prognostic impact of CMD in HCM patients, using angio-IMR as a novel non-invasive assessment tool.

Eligibility Criteria:
Inclusion Criteria:

1. diagnosed with hypertrophic cardiomyopathy(HCM) based on clinical guidelines
2. have qualified image for analysis of angio-IMR

Exclusion Criteria:

1）referred to hospital due to ST-segment elevation myocardial infarction(STEMI), heart failure and cardiopulmonary arrest; 2) Implantation of any DES or DCB; 3）severe valve dysfunction; 4）history of implantation of implantable cardioverter-defibrillator or pacemaker, septal myectomy or septal myocardial ablation; 5）meet the criteria of implantation of implantable cardioverter-defibrillator or pacemaker, septal myectomy or septal myocardial ablation; 6）impaired life-span expectancy due to cancer or other clinical conditions；
Cardiorespiratory Responses to a Pilates Training Session and Treadmill Walking in Healthy Adults

Low cardiorespiratory fitness is related cardiovascular and total mortality. In addition, disease risk is increased with low cardiorespiratory fitness. There is strong evidence that physical activity and cardiorespiratory fitness are associated with health variables in healthy individuals. Pilates exercises, which are the subgroups of physical activity, has become popular in recent years. Current evidence suggests that Pilates training improves body composition, respiratory muscle strength, exercise performance and quality of life. In addition to these benefits, recent evidence suggests that Pilates training can improve cardiorespiratory fitness. However, there is lack of evidence on whether practicing Pilates exercises satisfy recommendations for intensity of physical activity which improves and maintains health and cardiovascular fitness.

The primary aim of this study is to evaluate the cardiorespiratory responses during a Pilates training session, by measuring cardiorespiratory fitness through oxygen consumption and energy expenditure. The secondary aim of this study is to compare the cardiorespiratory responses during Pilates training session and treadmill walking at different speeds (3.2 kmh and 4.8 kmh).

First, resting metabolic rate will be measured. Then, the participants will be randomized to one of the two possible experimental conditions: (1) Pilates training session than treadmill walking or (2) treadmill walking than Pilates training session. Pilates session will consist of warm-up exercises (e.g. breathing, arm circle, cat and camel spinal rotation etc.) and basic mat exercises (e.g. one leg stretching, double leg stretching, the hundred, saw, rolling like a ball, swimming, pelvic curl etc.). The Pilates session will be presented to the participants via recorded video. Participants will walk on treadmill at two different speeds: 3.2 kph (2 mph) and 4.8 kph (3 mph). Participants initially will walk at pace of 3.2 kph for 10 minutes. After 30-40 minutes- rest (after returning baseline values), participants will walk on at pace of 4.8 kph for 10 minutes.


Eligibility Criteria:
Inclusion Criteria:

* Being healthy (not having any known chronic disease)
* Volunteer to participate in the study.

Exclusion Criteria:

* Pregnancy
* Previous disorder/surgery history that can alter physical performance in walking or Pilates session.
Evaluation of Clinical Outcomes in an Online Teledermatology Model for the Management of Psoriasis

The purpose of this study is to determine if an asynchronous online model of teledermatology can achieve similar clinical outcomes as compared to conventional in-office care for the management of psoriasis. The investigators also aim to determine the effects of this online care model on patient quality of life as well as patient and physician satisfaction.

The investigators' hypotheses include the following:

1. Compared to in-person visits, the online care model will result in similar clinical improvement in psoriasis disease severity.
2. Compared to in-person visits, the online care model will result in similar improvements in quality of life.
3. Providers and subjects in the online group will achieve a similar level of overall satisfaction as those in the in-person group.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older at time of consent, may be men or women.
* Requiring treatment of psoriasis for medically-indicated reasons.
* Capable of giving informed consent.
* Able to have their skin imaged by themselves or by family members.

Exclusion Criteria:

* Non-English speaking individuals.
* Individuals lacking access to a digital camera and computer with internet connection.
Women Urinary Incontinence Prevalence Study (WUIPS)

The goal of this multicenter prospective and prevalence observational study is to punctually investigate and describe prevalence, predictors, quality of life and costs of Urinary Incontinence (UI) among female patients, female caregivers and female personnel in four hospitals in Northern Italy: San Raffaele hospital in Milan, San Raffaele Turro hospital in Milan, Zingonia Policlinico San Marco (BG) and Policlinico San Pietro in Ponte San Pietro (BG).

EXPECTED RESULTS

The collection of data and information through this study will aim to:

1. Understand the percentage of middle-aged women with UI.
2. Describe the socio-demographic and clinical characteristics of women with UI.
3. Identify UI predictors.
4. Describe the quality of life, social impact and costs of women with UI.

Eligibility Criteria:
INCLUSION CRITERIA

* Female sex
* Middle age (40-65 years old)
* Informed consent signed
* Comprehension of written and spoken Italian language
* Female outpatients intended for any hospital unit (outpatient clinic, day surgery and day hospital patients included) and every female caregiver respecting the previous inclusion criteria, recruited at the central admission and at the private admission of the four hospitals involved
* Female workers (healthcare professionals and administrative personnel) of the four hospitals

EXCLUSION CRITERIA

* Male sex
* Young age (\< 40 years) and older age (\> 65 years)
* Pregnant women
* Puerperium women (up to 40 days post-partum)
* Women who had undergone urinary and gynecology surgery
Laparoscopic Guided Transversus Abdominis Plane Block Versus Trocar Site Infiltration in Gynecologic Laparoscopy.

to compare between Laparoscopic Guided Transversus Abdominis Plane Block and Trocar Site Infiltration as postoperative analgesia in Gynecologic Laparoscopic surgery.

two groups of patients who are eligible for Gynecologic Laparoscopy were randomized to either Laparoscopic Guided Transversus Abdominis Plane Block or Trocar Site Infiltration at the end of the operation.

Eligibility Criteria:
Inclusion Criteria:

* patients Need Gynecologic Laparoscopy

Exclusion Criteria:

* diagnosed with chronic pain syndrome
* have a postoperative intraperitoneal drain
* necessitating alteration to laparotomy.
Analgesia in Total Hip Arthroplasty by Quadratus Lumborum Block

Patients are painful after total hip arthroplasty. These patients have significant co-morbidities. Analgesics cause significant side effects in this population. Locoregional analgesia is therefore an effective means of reducing the consumption of opioids in this surgery.

The "gold standard" of locoregional analgesia after Total Hip Arthroplasty is the femoral block. However, a new technique has recently been described: the Quadratus Lumborum Block.

The comparison of these two techniques is lacking in the literature. The comparison of the Quadratus Lumborum Block to the femoral block in Total Hip arthroplasty is important in the analgesic strategy of patients undergoing this surgery.

The aim of this study is to compare the clinical efficacy of two regional locoregional analgesia strategies in total hip replacement surgery: the ultrasound-guided Quadratus Lumborum Block and the ultrasound-guided femoral block.

This is a double-blind, randomized study in prospective inclusion with a superiority test. Two groups of patients will be compared: a group of patients with a quadratus lumborum block and a group of patients with a femoral block.

Management (quadratus lumborum block or femoral block) will be randomized. The randomization will be stratified on the type of anesthesia (spinal anesthesia and general anesthesia). Randomization will be done on the day of surgery to determine the patient's treatment group. The surgical procedure will not be modified by the participation of the patent in the study.

Patients who would benefit from total hip replacement surgery in the Reims University Hospital and who agreed to participate in the study were included.

Eligibility Criteria:
Inclusion Criteria:

* Patients eligible for total hip replacement surgery in Reims University Hospital
* Patients agreeing to participate in the research and having signed informed consent
* between 18 yo and 95 yo
* Patients affiliated to a social security system

Exclusion Criteria:

* Patients with allergy to local anesthetics
* Patients with neuropathy
* Patients with an ASA score of 4
* Patients undergoing revision surgery for total hip arthroplasty
* Patients receiving anterior hip total hip replacement surgery
* Patients with a contraindication to the realization of the quadratus lumborum block, femoral block or spinal anesthesia (clinical coagulopathy, infection at the point of puncture ...)
* Patients refusing the proposed techniques
Myocet® in Children With Relapsed or Refractory Non-brainstem Malignant Glioma

The purpose of this study is to determine the toxicity and tolerance of Myocet® in children and adolescents with refractory or relapsed malignant glioma, with a dose diminished of 20% of the dose recommended for adults and a dose recommended for adults, administered in single dose in 1-hour perfusion each 21 days.

Other purposes are to determine the recommended dose of Myocet and to assess the response to drug. Pharmacokinetics of doxorubicin (free and encapsulated forms) and its metabolite doxorubicinol during 72 hours after Myocet administration will also be studied.


Eligibility Criteria:
Inclusion Criteria:

* Patients having received at least one cycle of chemotherapy after radiotherapy
* Patients having grade III or IV (WHO) glioma, not localized in brainstem
* Tumor measurable with magnetic resonance imaging
* Absence of other concomitant anti-cancer treatments
* Absence of chemotherapy for 4 weeks; 6 weeks if nitrosourea
* Good general health and nutritional status according to NCI-CTC scale (version 3) (appendix 6)
* Lansky score \> 50% or Karnofsky \> 50 in children older than 12 years
* Absence of organ toxicity (grade \> 2 according to NCI-CTC criteria (version 3)
* Hematology: polynuclear neutrophil count \> 1.0 x 109/l
* Hematology: platelet count \> 100 x 109/l
* Liver function: bilirubinemia \< 1.5 normal value
* Liver function: ASAT and ALAT levels \< 2.5 normal values
* Liver function: prothrombin level \> 70%
* Liver function: fibrinogen \> 1.5 g/l
* Renal function: creatinemia \< 1.5 normal value/age
* Cardiac function: EF \> 60% and/or SF \> 30%
* Signature of informed consent by patient if adolescent, by 2 parents or legal guardian if minor patient
* For patients with childbearing potential, a contraceptive method is compulsory. This contraception must be continued 6 months after Myocet treatment end
* For patients with childbearing potential, negative pregnancy test (betahCG test)

Exclusion Criteria:

* Non compliance with eligibility criteria
* Severe or life-threatening infection
* Non controlled evolutive or symptomatic intracranial hypertension
* History of Myocet treatment, but patients could be treated with anthracyclines if cardiac function is normal
* Hypersensibility to the active substance, to premixtures or one of excipients
* Pregnancy and breastfeeding
Interventional Treatment of Residual Pulmonary Hypertension in Patients After Pulmonary Thromboendarterectomy

The study evaluates the technique of non-drug treatment of residual pulmonary hypertension in patients with chronic thromboembolic pulmonary hypertension after pulmonary thromboendarterectomy.

The best strategy of treatment patients with chronic thromboembolic pulmonary hypertension is pulmonary thromboendarterectomy. In 5-30% of cases after pulmonary thromboendarterectomy residual pulmonary hypertension is persisted. The technique of radiofrequency pulmonary artery denervation in patients with idiopathic pulmonary arterial hypertension (type I) is known and was assessed during clinical investigation. In this study radiofrequency pulmonary artery denervation technique may be applied in patients with residual pulmonary hypertension after pulmonary thromboendarterectomy (type IV)

Eligibility Criteria:
Inclusion Criteria:

* presence of residual pulmonary hypertension in patients after pulmonary thromboendarterectomy according to right heart catheterization: mean pulmonary artery pressure \> 25 mm Hg or pulmonary vascular resistance \> 400 dyn x sec x cm-5

Exclusion Criteria:

* no evidence of residual pulmonary hypertension in patients after pulmonary thromboendarterectomy (mean pulmonary artery pressure \<25 m Hg).
* refusal of a patient to participate in the study.
* the presence of severe concomitant diseases of the cardiovascular system and lungs, leading to pulmonary hypertension
* the presence of other severe comorbidities that may result in death within a year.
MagicTouch Sirolimus Drug Coated Balloon Catheter for the Treatment of Coronary Lesions

The purpose of this study is to demonstrate the efficacy of MagicTouch DCB in reducing late lumen loss / suppressing neointimal tissue formation as assessed by Quantitative Coronary Angiography / Intravascular Ultrasound examination for the treatment of coronary artery lesions ranging from 3.0 mm to 3.5 mm of diameter and lesion length ≤ 15 mm.

Prospective, multicenter, randomized study designed to enroll 60 subjects with In-stent Restenosis, To demonstrate the efficacy of MagicTouch Drug-Coated Balloon in reducing late lumen loss / suppressing neointimal tissue formation as assessed by Quantitative Coronary Angiography / Intravascular Ultrasound examination for the treatment of coronary artery lesions ranging from 3.0 mm to 3.5 mm of diameter and lesion length ≤ 15 mm.

Eligibility Criteria:
Inclusion Criteria:

1. The patient must be ≥18 and ≤ 80 years of age
2. Symptomatic ischemic heart disease;
3. Acceptable candidate for Coronary Artery Bypass Graft (CABG) or Angioplasty;
4. Target lesion located in a native coronary artery
5. Target lesion (maximum length is 15 mm by visual estimate) covered by a single balloon;
6. Reference vessel diameter must be ≥3.0 to ≤ 3.5 mm by visual estimate;
7. Target lesion ≥50% and \<100% stenosed by visual estimate
8. Restenosis of initially stented main vessel.

Exclusion Criteria:

1. Pregnant or nursing patients and those who plan pregnancy in the period up to 1 year following index procedure;
2. Patient has had a known diagnosis of acute myocardial infarction (AMI) within 72 hours preceding the index procedure;
3. Lesions in bypass grafts or bifurcations
4. Any non-target vessel or lesion intended to be treated during the index procedure, which is an unprotected left main, ostial lesion, chronic total occlusion (CTO), heavily calcified, bifurcation, vein grafts, have angiographic evidence of thrombus, be anything requiring atherectomy, thrombectomy, or pre-treatment with anything other than balloon angioplasty;
5. Patient presents with cardiogenic shock;
6. Patient has extensive peripheral vascular disease that precludes safe 6 French sheath insertion
7. Unprotected left main coronary artery disease with ≥50% stenosis;
8. Totally occluded target vessel (TIMI flow 0);
9. Calcified target lesion(s) which cannot be successfully pre-dilated;
10. A significant (\>50%) stenosis proximal or distal to the target lesion that cannot be covered by same single balloon
11. Diffuse distal disease to target lesion with impaired runoff;
12. Left ventricular ejection fraction (LVEF) ≤30% (LVEF must be obtained within 1 months prior to the index procedure).
Continuous Negative External Pressure for the Treatment of Primary Snoring

The aim of this pilot study is to gain information on the ability of a continuous negative external pressure collar to safely reduce snoring in primary snorers, and if so to determine whether the reduction in snoring has benefits for both the snorer and the bed partner. This clinical trial will involve both the snorer and his or her bed partner, both of whom must qualify and provide informed consent for participation.


Eligibility Criteria:
Key Snorer Inclusion Criteria:

* BMI \<35
* if a previously done polysomnogram (PSG) is available, AHI\<5
* snoring identified by a previous PSG and/or by the bed partner

Key bed partner Inclusion criteria

* must have regularly slept with the snorer over the previous month and must plan to sleep with the snorer for the duration of the trial
* considers that the snorer's snoring is a problem
* must discontinue use of any snore-masking equipment or ear plug for at least two weeks prior to the initial visit to the study site and agree to refrain from their use for the duration of the trial

Key snorer exclusion criteria:

* sleep disturbance other than snoring
* snoring due primarily to abnormality of the nasopharynx
* use of snoring treatment during the month prior to the initial visit
* neck anatomic or skin abnormalities
* serious medical condition
* excessive drug or alcohol intake

Key bed partner exclusion criteria:

-known sleep disorder