cyrilzakka/clinical-trials huggingface dataset:
Non-analgesic Effects Produced by Equipotent Analgesic Doses of Sufentanil, Hydromorphone, and Oxycodone

This study aimed to investigate Non-analgesic Effects Produced by Equipotent Analgesic Doses of Sufentanil, Hydromorphone, and Oxycodone in female patients. Methods: A total of 60 patients were randomly divided into 4 groups, with 20 patients in each group. Sufentanil(0.1μg/kg), Hydromorphone(20μg/kg), or Oxycodone(60μg/kg) ,saline(10ml)was administered before anesthesia induction. Bispectral Index (BIS), Respiratory rate(RR), other non-analgesic effects at Tb (entering room), T0 (drug administration), T1 (2min), T2 (4min), T3(6min), T4(8min), T5(10min), T6(20min) were recorded.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists GradeⅠ-II;
* Patients undergo low-risk elective surgery for benign diseases (including laparoscopic ovarian cyst removal, laparoscopic tubal ligation, laparoscopic tubal drainage, breast operation, thyroid operation, etc) ;
* Aged 18-45 years;
* Body Mass Index 18-25kg/m2, weight 40-65 kilograms;
* Agreed to participate in the research

Exclusion Criteria:

* Difficult airway;
* upper respiratory tract infection within 2 weeks;
* history of allergy or long-term use of propofol and opioids;
* self-rating anxiety scale before operation indicates anxiety;
* pregnancy or lactation.
Identification the Cause of Silent Cerebral infarctiON in Healthy Subjects (ICONS)

We hypothesized that paradoxical embolism may be one of the main mechanisms of silent cerebral infarction (SCI) located outside the perforating artery territory. In the present study, we evaluated the association between SCI and paradoxical embolism detected by agitated saline transcranial Doppler (TCD) monitoring in healthy subjects without history of stroke or transient ischemic attack (TIA). We also compared the frequency and amount of paradoxical embolism between healthy subjects with SCI and acute stroke patients with presumed cryptogenic embolism or conventional stroke mechanisms.


Eligibility Criteria:
Inclusion Criteria:

Healthy subjects

* Subjects with age over 20 years
* Subjects who consecutively visited a health promotion center for a health screening examination that included routine laboratory test, cardiac work-ups (12-lead electrocardiography and/or echocardiography), and brain magnetic resonance image (MRI) and MR angiography (MRA)
* Subjects who showed silent brain infarction (SCI) which was defined as a focal hyperintensity lesion 3 mm or large in diameter in the fluid-attenuation inversion recovery (FLAIR) images without a history of a corresponding stroke or transient ischemic attack (TIA)
* Subjects who performed agitated saline transcranial Doppler (TCD) monitoring

Patients with acute stroke (both cryptogenic embolic stroke and conventional stroke mechanisms)

* Patients with age over 20 year
* Patients with focal neurologic deficits presented within 7 days of symptom onset
* Patients with acute ischemic lesions on diffusion-weighted image (DWI)
* Patients who performed agitated saline TCD monitoring

Exclusion Criteria:

Healthy subjects

* Subjects with the presence of previous history of stroke or TIA
* Subjects with the presence of dementia on history taking or mini-mental status examination
* Subjects with the presence of proximal source of embolism, including atrial fibrillation or significant (≥50%) stenosis on cervicocerebral artery on MRA or carotid Duplex
* Subjects who had SCI restricted within perforator territory (basal ganglia or pons) suggesting that microangiopathy rather than embolism could be the main mechanism of SCI
* Subjects in whom agitated saline TCD monitoring was not performed or those who had poor temporal windows

Patients with acute stroke (both cryptogenic embolic stroke and conventional stroke mechanisms)

* Patients in whom agitated saline TCD monitoring was not performed or those who had poor temporal windows
Systematic Review and Meta-Analysis on DCB vs. POBA in De-novo Femoropopliteal Disease

Restenosis is still an issue after endovascular revascularization for femoropopliteal occlusive disease. One approach to reduce the rates of restenosis and reintervention is local application of Paclitaxel with drug-coated balloon angioplasty. The purpose is to conduct a systematic review and meta-analysis of randomized-controlled trials comparing on Drug-Coated Balloon angioplasty (DCB) vs. Plain Old Balloon Angioplasty (POBA) in de-novo femoropopliteal disease.

Peripheral arterial disease is the third leading entity of atherosclerosis. The femoropopliteal segment is affected in most patients. Endovascular revascularisation is one possible treatment option, but high rates of restenosis, especially in complex lesions, are a limiting factor. Bare-metal stents failed to show a long-term superiority in a Cochrane systematic review. Another approach to prevent restenosis is local delivery of an antiproliferative drug (e.g. Paclitaxel) via Drug-Coated Balloon Angioplasty. New studies did report their results since the publication of earlier meta-analyses. It's time for an up-to-date systematic review. Prior systematic reviews did not address risk of bias nor did they take differences in treatment strategy despite the used balloon catheter into consideration.Some previous reviews did compare results from different points in time, e.g. analysis of 6 months' results together with 24 months' results.

Eligibility Criteria:
Inclusion Criteria:

* Randomized controlled trials
* DCB vs. POBA
* focus on de-novo femoropopliteal lesions
* registration in a clinical trials registry
* available study protocol (either in clinical trial registry or published)

Exclusion Criteria:

* non-randomized controlled trials
* focus on below-the-knee interventions
* focus on iliac artery interventions
* focus on treatment of critical limb ischemia
* focus on treatment of in-stent restenosis
* usage of additional devices except for bare-metal stent (e.g. atherectomy)
CRQ Survey Study: Clinical Research Questionnaire of Oncology Patients - A Nationwide Survey

This is a translational, multicentre questionnaire study. The study design follows that of a cross sectional, quantitative research approach. Data collection will involve self-administered, paper-based questionnaires. The method of data collection allows for a large sample size without major expense. The questionnaires are comprised of several questions examining areas such as demographic details, cancer diagnosis, understanding of the term 'clinical trials', attitudes to personal participation in cancer clinical research and the experience of patients who previously participated in a cancer clinical trial. The study will be opened in all interested hospitals in Ireland following initiation of the study at each site. Questionnaire completion will be seen as implied informed consent and no formal consent will need to be signed by the patient. The paper-based questionnaire responses will be electronically and anonymously recorded in a computer database to facilitate analysis.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of malignancy
* Aged 18 years or older
* Ability to complete the questionnaire or independently or with the help of a friend, relative, or staff member of the oncology department

Exclusion Criteria:

* N/A
Non Invasive Ventilation in Acute Asthma

The aim of this study is to compare the efficacy of noninvasive positive pressure ventilation versus best medical therapy in patients with acute severe asthma

In the past, the mainstay of treatment for patients progressing to respiratory failure from acute asthma was intubation and mechanical ventilation. Newer strategies to prevent these intubations to prevent the inherent complications are being explored in form of various pharmacological means like heliox, magnesium sulfate etc. Non pharmacological strategies among which non invasive positive pressure ventilation (NIPPV) is one of the most challenging after showing success in patients with chronic obstructive airway disease (COPD) and cardiogenic pulmonary edema.

Data on efficacy of NIPPV in the management of AA is sparse but has the potential to improve the management of acute severe asthma. Noninvasive ventilation merits further studies in patients with AA, and some consensus panels have suggested that its widespread application in patients with asthma await such trials.The role of NIPPV is not yet clear and needs further studies and keeping this in view we planned this study to study the role of NIPPV in the management of acute asthma.

Eligibility Criteria:
Inclusion Criteria:

1. History of asthma of at least 1 year
2. FEV1 \< 50% of predicted (by age, height, and gender) or FEV1 \< 200 L/minute
3. Respiratory rate \> 30 breaths/min
4. All patients judged by the attending physician as having an acute attack of asthma ( Inability to speak in sentences in one breath, SaO2 \< 92% ,pulsus paradoxus \> 10 mm of Hg) -

Exclusion Criteria:

1. Smoking history of \> 10 years
2. Chronic obstructive pulmonary disease
3. Endotracheal intubation
4. Room air saturation \< 88 % or arterial PaO2 \< 55 mm of Hg
5. Hemodynamic instability defined as systolic BP \< 90 mm Hg
6. Altered state of consciousness
7. Congestive heart failure
8. Ischemic heart disease
9. Upper airway obstruction
10. Facial deformity
11. Pregnancy
12. Pulmonary infiltrates consistent with pulmonary edema or pneumonia
Effects of DHEA and Exercise in the Elderly

DHEA or dehydroepiandrosterone is a naturally occurring hormone secreted by tghe adrenal galnds. The secretion of HDEA declines with aging. DHEA is considered a food supplement and it is not regulated by the FDA. The purpose of this research is to evaluate ceratin of the biological effects of a reaplcement dose of DHEA. As you get older, DHEA levels are lower than you were younger. The replamcent dose is the dose of DHEA that will raise DHEA levesl to the levels found in young people. Anotehr purpose is to determine whether DHEA enhances the adaptations to an exercise training program.

DHEA declines dramatically with age. Low DHEA levels have been found to correlate with sarcopenia and osteopenia. It is, therefore, postulated that many physiologic changes of aging are secondary to the decline in DHEA. Thus, the objective of the proposed research is to evaluate the effect of DHEA replacement on age-related changes in body composition, muscle function and metabolism, and bone mass in healthy older adults. The specific aims are to evaluate the effects of DHEA replacement (50 mg/d) alone, or in combination with resistance exercise training on: a) lean body mass, intraabdominal fat and thigh muscle volume, and muscle protein synthesis rate b) bone mineral density (BMD) of the total body, lumbar spine, and hip and biochemical markers of bone turnover and c) insulin sensitivity. It is hypothesized that DHEA administration will have additive or synergistic effects with exercise. Healthy but sedentary subjects , aged 65-78 years old, will be randomized to receive either DHEA, 50 mg/d, or placebo and to participate in either supervised or home exercise training programs. The supervised exercise program will consist of resistance training designed to increase muscle mass, strength, and bone mass, and decrease fat mass. The goal of this research is to provide information on the potential role of DHEA replacement therapy in maintaining the physical health and functional capacity of older people

Eligibility Criteria:
Inclusion Criteria:

* 65 to 78 years old men and women

Exclusion Criteria:

* hormone therapy, history of hormone-dependent neoplasia, PSA above 2.6 ng/mL, or active serious illness, contraindications to exercise, dementia
Validation Fugl-Meyer in Italian Language (FMI)

The aim of the study is to perform a cultural validation of the Italian translation of the Fugl-Meyer Assessment scale for the upper and the lower limb on a group of post-stroke patients admitted to the neurological department at The Don Carlo Foundation.

The purpose is to validate the Italian translation of the Fugl-Meyer Assessment scale in order to allow immediate clinical use.

The Fugl-Meyer Assessment (FMA) is one of the most used and recommended assessment scales of sensorimotor function in stroke. It was introduced for the first time by Axl Fugl-Meyer and collaborators and originally published in both English and Swedish, representing the first quantitative assessment tool for the hemiplegic patient.

The FMA is a valid, reliable, responsive and most widely used standardized clinical scale for the evaluation of the degree of sensory and motor impairment of the hemiplegic patient, and to date is considered one of the most used tools worldwide. Extensive research has shown that FMA is easy to use and does not require special equipment, making it particularly suitable for different types of clinical setting around the world.

There are many currently translation and cultural validation studies of the FMA in several languages (Danish, Norwegian, Spanish, French), but an official version validated in Italian is no available to date.

This study aims to perform and develop a transcultural validation of the FMA for the upper and the lower limbs in Italian, following a methodological approach, already validated, for the process of translation and cultural adaptation, including formal involvement of the University of Gothenburg, which holds the rights on the original scale.

The translated version in Italian is tested by 3 physiotherapists admitted to the neurological department at The Don Carlo Foundation, in order to identify lingual and conceptual inconsistencies that could influence the score, the understanding, the interpretation and the cultural equivalence of the scale.

Eligibility Criteria:
Inclusion Criteria: 70 individuals with first-ever stroke will be enrolled. Eligible subjects will be in-patients with an acute event occurred no later than 15 days from admission at the "neurological department " at the Don Carlo Gnocchi Foundation.

Exclusion Criteria:

Visual and/ or hearing deficits, amputation of the upper or lower limb, cerebellar stroke; previous strokes (relapse), cognitive decline (MMSE\<21).
Epidemiological Study on Haemophilia Care and Orthopaedic Status in Developing Countries

This study is conducted in Africa and Asia. The aim of this study is to evaluate in the participating countries the orthopaedic status and the degree of arthropathy of severe haemophilia patients in general.


Eligibility Criteria:
Inclusion Criteria:

* Patient (and/or parents or the patient's legally acceptable representative, if applicable) must give signed and dated informed consent before enrolment in the study
* Male patients at least 6 years old with diagnosis of severe congenital haemophilia A or B with or without inhibitors
* Patients receiving on demand replacement factors/bypassing agents therapy

Exclusion Criteria:

* Clinically relevant coagulation disorders other than congenital haemophilia A or B
* Patients on currently active treatment for HCV (Hepatitis C Virus) or HIV (Human Immune Deficiency Virus) infections
Glucomannan Effects on Children With Non-alcoholic Fatty Liver Disease

Non-alcoholic fatty liver disease (NAFLD) has reached epidemic proportions and is rapidly becoming the one of most common causes of chronic liver disease in children. The pathogenesis of NAFLD is generally considered the result of a series of liver injuries, commonly referred as "multi-hit" hypothesis. Insulin resistance and increased serum levels of free fatty acids (FFAs) are considered the main primary hits that lead to the excessive lipid accumulation in hepatocytes resulting in steatosis.

Has been reported that a diet rich in high-viscosity fiber improves glycemic control and lipid profile, suggesting a therapeutic potential role in the treatment of NAFLD.

Aim of this study is to evaluate the efficacy and tolerability of glucomannan in children affected by non alcoholic fatty liver disease.


Eligibility Criteria:
Inclusion Criteria:

* informed consent by parents or legal tutor
* ALT levels \<10 ULN
* hyperechogenicity at liver ultrasound examination suggestive of fatty liver
* INR \< 1,3
* Albumin \> 3 g/dl
* total bilirubin \< 2,5 mg/dl
* no previous gastrointestinal bleeding
* no previous portosystemic encephalopathy
* normal renal function
* no HIV-HCV-HDV infection
* normal cell blood count

Exclusion Criteria:

* every clinical or psychiatric disease interfering with experimentation according to investigator's evaluation
* finding of active liver disease due to other causes
* corticosteroids, immunosuppressive drugs or chemotherapy in the 2 months before of the study
* alcohol consumption
* use of drugs known to induce steatosis or to affect body weight and carbohydrate metabolism
* finding of actual or previous level of alpha-fetoprotein \> 50 ng/ml
* hepatocellular carcinoma
* diabetes mellitus type I
Evaluation of the Implementation of a Quality Improvement Program Through Morbidity and Mortality Reviews

Morbidity and mortality reviews represent an opportunity to discuss adverse events and healthcare issues. Aim is to report the first experience of implementing a standardized procedure of morbidity and mortality reviews, and assess its impact on quality improvement.

From July 2019 to December 2019, members of the surgical and intensive care unit departments designed and implemented a regular procedure of morbidity and mortality reviews. Cases of severe postoperative complications after curative resection for digestive cancer were selected to be presented by a surgical resident and discussed in an interdisciplinary conference following a standardized presentation based on an analysis tool adapted from the ALARM framework. Process was assessed by the number of morbidity and mortality reviews held, number and type of recommendations issued and implemented.

Among 13 serious complications during the study period, 10 were discussed. The "Tasks" category was activated in 90% of the cases where lack or misuse of protocols was identified in 90% of the events discussed. Test results availability or accuracy were incarnated in 30% of cases. Poor communication was a contributing factor in 60% of the cases. Written medical records were defective in 40% of the cases. From 16 recommendations for improvement emitted, 87.5% (14/16) were translated into projects and successfully implemented.

Thus, a standardized and regular procedure of morbidity and mortality reviews in a tertiary care facility in a developing country allowed a significant improvement in patient care through quality initiatives implementation. Morbidity and mortality reviews might be a strong tool for the improvement of surgical care particularly for low-mid income countries

Eligibility Criteria:
Inclusion Criteria:

* severe adverse events defined as postoperative morbidity \> 3a according to the Clavien Dindo grading system
* within the first 90 postoperative days of surgery
* Cases discussed in a morbidity and mortality review

Exclusion Criteria:

* Cases not discussed in a morbidity mortality review
Study of Obicetrapib & Ezetimibe Fixed Dose Combination on Top of Maximum Tolerated Lipid-Modifying Therapies

The study is a placebo-controlled, double-blind, randomized, phase 3 study in participants with heterozygous familial hypercholesterolemia (HeFH) and/or atherosclerotic cardiovascular disease (ASCVD) or multiple ASCVD risk factors to evaluate the efficacy, safety and tolerability of obicetrapib 10mg and ezetimibe 10mg fixed dose combination as an adjunct to diet and maximally tolerated lipid-lowering therapy.

This study will be a placebo-controlled, double-blind, randomized, phase 3 study in participants with heterozygous familial hypercholesterolemia (HeFH) and/or atherosclerotic cardiovascular disease (ASCVD) or multiple ASCVD risk factors to evaluate the efficacy, safety, and tolerability of obicetrapib as an adjunct to diet and maximally tolerated lipid-lowering therapy. The screening period for this study will take up to 14 days. Afterwards patients will be randomized 1:1:1:1 to Obicetrapib 10 mg and ezetimibe 10 mg fixed dose combination, obicetrapib 10 mg, ezetimibe 10 mg or placebo for a 84 day treatment period. After the treatment period, patients will have an end of study follow-up visit.

Eligibility Criteria:
Inclusion Criteria:

* Have underlying HeFH and/or a history of ASCVD or multiple ASCVD risk factors
* On maximally tolerated lipid-modifying therapy as an adjunct to a diet and lifestyle modifications
* LDL-C ≥ 70 mg/dL
* Triglycerides \< 500
* Estimated glomerular filtration rate ≥ 15 mL/min/1.73 m2

Exclusion Criteria:

* History of New York Heart Association (NYHA) class III or IV heart failure of left ventricular ejection fraction \<30%
* Hospitalized for heart failure within the last 5 years
* Myocardial infarction, stroke, non-elective coronary revascularization or hospitalization for unstable angina or chest pain in the last 3 months
* Uncontrolled severe hypertension
* Diagnosis of homozygous FH
* Liver disease
* HbA1c ≥ 10.0% or fasting glucose ≥ 270 mg/dL
* Thyroid-stimulating hormone \>1.5 x upper limit of normal (ULN)
* History of malignancy
* Creatinine kinase (CK) \>3 X ULN
* Alcohol abuse
* Treatment with investigational product
* Treatment with gemfibrozil or ezetimibe
* Previous participation in a trial evaluating obicetrapib
* Known allergy to study drugs, placebo or excipients in study drugs of placebo
* Other condition that would interfere with the conduct of the study
Right Hepatectomy in Patients Beyond 70 Years Old

As a consequence of the increase in life expectancy, hepato-biliary surgeons have to deal with an emerging aged population, which has a potential higher risk for complication and worse long-term outcome. The investigators will be analyzing the liver function and outcome after right or extended right hepatectomy in patients over 70 years old.


Eligibility Criteria:
Inclusion Criteria:

* Age \>= 18 years
* Elective right hepatectomy
* Elective extended right hepatectomy

Exclusion Criteria:

* Age \< 18 years
* Pregnancy
* Other type of hepatectomy
* Emergency hepatectomy