cyrilzakka/clinical-trials huggingface dataset:
A Comparison Between Propofol-Remifentanil and Midazolam-Remifentanil Sedation in the Intensive Care Unit

The purpose of this study is to compare propofol-remifentanil sedation with midazolam-remifentanil sedation in regards to extubation and weaning time, length of stay in the ICU, as well as the incidence of delirium. Primary end-points were weaning time and extubation time, and secondary end-points were the incidence of delirium and length of stay in the ICU.

With on-going emphasis on early extubation, as well as further recognition of morbidity and mortality associated with delirium, the specific sedatives and analgesics used in the ICU is an issue of interest. Recent studies have focused on comparing sedatives, but interpretations are often confounded by the fact that in most studies, different analgesics were used when comparing two sedative medications. The role of remifentanil as the main analgesic in the ICU is being recognized. Pharmacodynamic and pharmacokinetic profiles of remifentanil makes it an ideal analgesic in the ICU setting. The investigators therefore designed this randomized study to compare sedation with propofol and midazolam in a remifentanil-based sedation and analgesia.

The purpose of this study is to compare propofol-remifentanil sedation with midazolam-remifentanil sedation in regards to extubation and weaning time, length of stay in the ICU, as well as the incidence of delirium. Primary end-points were weaning time and extubation time, and secondary end-points were the incidence of delirium and length of stay in the ICU.

Eligibility Criteria:
Inclusion Criteria:

* surgical patients over 18 years old who were admitted to the ICU for postoperative ventilator care after sevoflurane-remifentanil based general anesthesia

Exclusion Criteria:

* pre-existing neurologic dysfunction (dementia)
* head trauma patients
* previous history of alcohol abuse or substance abuse
* patients who had baseline serum creatinin levels of over 2.5mg/100ml
* uncompensated liver cirrhosis
* hemorrhagic, cardiogenic, or septic shock
* pregnancy or breast feeding
* tracheostomy or extubation before ICU admission.
Obatoclax Mesylate in Samples From Young Patients With Acute Myeloid Leukemia

RATIONALE: Studying the effects of obatoclax mesylate in cell samples from patients with cancer in the laboratory may help doctors learn more about the effects of obatoclax mesylate on cancer cells. It may also help doctors identify biomarkers related to cancer.

PURPOSE: This research study is studying obatoclax mesylate in samples from young patients with acute myeloid leukemia.

OBJECTIVES:

* Determine comprehensive gene and protein expression profiles of in vitro sensitivity and resistance to obatoclax mesylate in multiple-lineage leukemia (MLL)-rearranged cell lines and primary infant acute myeloid leukemia (AML) samples.
* Define optimum in vitro combinations of obatoclax mesylate targeting pro-survival BCL-2 family proteins with cytotoxic drugs in MLL-rearranged leukemia cell lines and primary infant AML samples.
* Identify synergistic combinations based on a pharmacodynamic modeling and simulation construct.
* Determine whether combinations of obatoclax mesylate targeting pro-survival BCL-2 family proteins with cytotoxic drugs improves survival in a xenograft model of MLL-rearranged infant AML.

OUTLINE: This is a multicenter study.

Obatoclax mesylate activity is assessed via the MTT assay. A priori features of acute myeloid leukemia (AML) blasts relating to the apoptosis and ATG cell death pathways and their execution are characterized using microarray analysis and quantitative real-time (Q-RT) PCR. Gene and protein expression is described and quantified using Q-RT PCR and western blot analysis at specific time points after obatoclax mesylate exposure to identify pharmacodynamic biomarkers of activity and characterize the cell death mechanism in multiple-lineage leukemia (MLL)+ AML. The MTT assay is performed using obatoclax mesylate-cytotoxic chemotherapy combinations to determine synergy focusing on common cytotoxic drugs employed in AML treatment regimens.

Obatoclax mesylate efficacy is tested in a therapeutic NOG xenograft model of primary MLL+ infant AML.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of acute myeloid leukemia (AML)
* Cryopreserved samples from infants with AML available

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified
A Study of Tarceva (Erlotinib) and Gemcitabine in Treatment-Naive Patients With Advanced Non-Small Cell Lung Cancer.

This 2 arm study will assess the efficacy and safety of Tarceva plus gemcitabine, compared with gemcitabine alone, in the treatment of chemotherapy-naive patients with advanced non-small cell lung cancer. Patients will be randomized to receive either Tarceva 150mg po daily plus gemcitabine on days 1, 8, 15 and every 4 weeks subsequently, or with gemcitabine monotherapy. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, \>=18 years of age;
* non-small cell lung cancer, stage IIIb (with effusion) or stage IV with measurable disease ;
* ECOG PS 2;
* adequate organ function.

Exclusion Criteria:

* prior chemotherapy or systemic anti-tumor therapy;
* hypersensitivity to erlotinib;
* any condition contraindicating the use of the study medication and/or impairing the interpretation of results and/or leading to treatment-related complications.
Dexmedetomidine Infusion During Laparoscopic Adrenalectomy

The investigators planned this study to investigate the effects of dexmedetomidine administration on intraoperative hemodynamic stability in patients with pheochromocytoma.


Eligibility Criteria:
Inclusion Criteria:

1. ages of 20 and 70
2. American Society of Anesthesiologists(ASA) physical status classification I to III,
3. planned laparoscopic adrenalectomy for pheochromocytoma.

Exclusion Criteria:

1. emergency operation,
2. re-operation,
3. combined surgery with other departments,
4. body mass index (BMI) \>32 kg/m2,
5. history of arrhythmias (especially AV nodal block) and ventricular conduction abnormalities,
6. uncontrolled hypertension (diastolic blood pressure \>110mmHg)
7. bradycardia (heart rate \< 40 beats per minute),
8. history of heart failure, hepatic and/or renal failure,
9. history of cerebrovascular disease (cerebral hemorrhage, cerebral ischemia),
10. history of beta-blocker therapy, 10) history of uncontrolled psychiatric disease.
Psychological Predictors in Colorectal IBD Surgery Recovery

This is an observation pilot trial aimed to study to the association between mindfulness and other psychological factors, including both protective and risk factors, with recovery of functional ability following colorectal surgery for Inflammatory Bowel Diseases (IBD), including Crohn's disease and Ulcerative Colitis.

The chronic nature of Inflammatory Bowel Disease (IBD) leads to a significant impact on patients' lives, beyond intestinal symptoms alone. The sequelae of this can be seen in the increased rates of depression and reduced quality of life (QoL). Surgery may provide a way to effectively induce long-term symptoms remission, although there is a short postoperative transitory period whereas quality of life might decrease. Over the last years, increasing interest has been gained by perioperative recovery protocols, aiming to accelerate functional recovery and to reduce complications. Some of these protocols include an in-depth discussion with both dedicated nurses and/or surgeons to decrease surgery-associated stress reaction. Nevertheless, no one of the proposed protocols has included a psychological assessment in order to correlate it with functional recovery. We suggest that studying the psychological characteristics of the patients (with a specific focus on mindfulness) could lead to open a new research front to optimize patients' outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Patients \> 18 years old (both males and females).
* Patients diagnosed with Inflammatory Bowel Disease (Crohn's Disease or Ulcerative Colitis).
* Patients scheduled for elective open or laparoscopic surgery for curative intent.

Exclusion Criteria:

* Patients unable to give the written informed consent.
* Patients \< 18 years old.
* Patients undergoing surgery in emergency setting.
* Patients with pre-operative evidence of colorectal cancer or High Grade/Low grade dysplasia.
* Pregnant or breastfeeding patients.
* Any condition that, in the opinion of the investigator, can interfere with the study protocol (e.g. neuropsychiatric disorders or dementia)
Comparing SonoVue With Sonazoid Using CEUS-LIRADS in HCC

The new version of CEUS LI-RADS published at 2018(version 2017). In this study, the investigators aim to investigate the diagnosing performance of CEUS LI-RADS by administrating different contrast agents (SonoVue/ Sonazoid).

Independent radiologists from department of ultrasound will report their diagnosing results according to CEUS LI-RADS version 2017 without getting any information about patients. The researcher of this subject will collect all results and evaluated the sensitivity and specificity of CEUS LI-RADS and the diagnosing performance with different contrast agents.

Eligibility Criteria:
Inclusion Criteria:

* Patients at risk for HCC with focal liver lesion on conventional ultrasound.
* history of cirrhosis.
* historty of HBV infection.

Exclusion Criteria:

* systemic therapy with sorafenib
* pretreat lesion
* patients don't sign the informed consent.
The Significance of Peripheral Input

The investigators want to examine trigger point injections of local anesthetics, in patients with post operative neuropathic pain, determine changes in sensory disturbances such as allodynia, hyperalgesia and thermal sensitivity and examine whether trigger point injections will attenuate pain in rest and activity.

The presence of cutaneous trigger points in the surgical incision of patients with post-surgery pain has been shown in our pain clinic, all patients have persistent pain for more than 3 month and different sensory disturbances.

Examinations with trigger point injections of local anesthetics have been used to determine the influence of peripheral changes and the significance of afferent input on persistent post-surgery neuropathic pain.

In the present study the investigators will document the influence of cutaneous trigger point injections for both subjective pain experience and objective findings in the area such as allodynia, hyperalgesia and thermal sensitivity. The investigators expect reduction in spontaneous pain intensity and de-crease in peripheral sensory disturbances and will determine the significance of peripheral input in persistent neuropathic pain.

The investigators aim to investigate whether injection of local anesthesia into trigger points compared with placebo (saline) injection will attenuate pain and normalize abnormal sensations, such as hyperalgesia and allodynia. The investigators believe this to be an important investigation to understand the mechanisms behind chronic post-surgery pain.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years old
* Patients with chronic pain (daily VAS pain scores \>30 mm) for at least 3 months after knee, shoulder or foot surgery
* Patients with at least one identifiable trigger point in relation to incision from the knee, shoulder or foot surgery. A trigger point is defined as an ar-ea in relation to the incision from surgery, in which a light pressure from a cotton pin radiate pain to the nearby area, and exudes a motor reflex causing withdrawal of the leg
* A written informed consent to participate in the study after having fully understood the contents of the protocol and restrictions

Exclusion Criteria:

* Patients who cannot cooperate
* Patients who cannot understand or speak Danish.
* Patients with allergy to the drugs used in the study
* Patients in treatment with vitamin K antagonists.
* Patients with other pain conditions
* Patients with diabetes
Treatment of Plantar Keratosis With Medicinal Plant in Diabetic Patients

This study evaluates the addition of medicinal plant in the treatment of diabetic foot keratosis. Half of participants will receive medicinal plant and other half will receive a placebo.

Keratosis in feet or plantar callosity is an injury caused by friction or pressure in certain location of the skin. This is a common problem faced by diabetic patients, which usually cause subcutaneous tissue maceration, which favors bacterial invasion. It is responsible for the development of abscesses and ulcers. Ulcer is the main cause of non-traumatic amputation of the feet in diabetic patients. Treatment with medicinal plants is an ancient practice. Brazil has one of the richest floras in the world. Brazilian Ministry of Health recommends the rational use of medicinal plants and encourage the use of this practice by health professionals.

The medicinal plant used in this study is a keratolytic agent, healing, emollient, bactericide and fungicide. The purpose of this study is evaluate the effectiveness of this medicinal plant in the treatment of keratosis in diabetic patients. This study will be controlled, randomized, comparative with standard drug and double-blind. Will be included in the study 90 adult diabetic patients type 1 or 2, with keratosis, both sexes, but do not show feet ulcerated lesions. Patients will be randomised controlled trials in three groups, with 30 people in each, which will receive topical treatment with medicinal plant (treatment group, TG), salicylate 10% (salicylate group, SG) and vaseline cream (control group, CG). The treatment will be once a day, for 30 consecutive days. Numerical scores will be made of the sites with keratosis and individual areas and global measures in the first, 30th days of treatment. The results obtained will be submitted to statistical comparison. This research will follow the standards set by resolution 466/12 of the National Health Council, the Vale do Sapucaí University, for research with human beings and will be conducted in accordance with the ethical recommendations of the Declaration of Helsinki.

Eligibility Criteria:
Inclusion Criteria:

- diabetic patients type 1 and 2 with plantar keratosis

Exclusion Criteria:

- feet ulcerated lesions
Probiotic Efficacy in VRE Eradication

This study will evaluate the efficacy of a probiotic lactobacillus strain in eradicating VRE in non-symptomatic carriers after 4 weeks of treatment. It will also evaluate the long-term efficacy after 8,16 and 24 weeks.

With the increased number of Vancomycin-Resistant Enterococcus faecium (VRE) infected/colonized people it is evident that new treatment options are needed to reduce the number of VRE cases. One such option could be to use probiotics. We hypothesize that treatment with a probiotic lactobacillus strain can reduce the number of VRE carriers significantly. The aim is to investigate if this strain can eradicate VRE in non-symptomatic VRE-carriers measured as the number of subjects without VRE colonization at week 4.

This is a multi-center, randomized, double-blind, placebo-controlled parallel-group trial in non-symptomatic VRE-carriers.

The Trial consists of a 4 weeks intervention period followed by a 20-week follow-up period.

After patients have been confirmed as carriers of VRE, the subjects are randomized to 4 weeks' treatment with a lactobacillus probiotic strain (60 billion CFU per day) or to placebo. Subjects' VRE carrier-state is assessed at weeks 4, 8, 16 and 24, by an in-house PCR analysis. Stool samples are collected before intervention (baseline) and at week 4, 8, 16 and week 24.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with VRE colonization (positive faecal swab)
* Subjects over 18 years of age
* Provided voluntary written informed consent

Exclusion Criteria:

* Symptomatic VRE infection
* Serious immunodeficiency
* Pancreatitis
* Planned or recent intraabdominal operation within a time window of14 days)
* Parenteral nutrition
* Antibiotic treatment for VRE one month prior to inclusion
* Terminal disease with expected survival time \< 3 month
* Probiotic consumption within two weeks prior enrollment
* Pregnant
Effect of Educational Program About Preventive Care Bundle for Prevention of Ventilator Associated Pneumonia Among Newborns

This study is designed to investigate the effect of educational program for nurses about preventive care bundle for prevention of ventilator associated pneumonia among newborns.

Neonatal ventilator associated pneumonia (VAP) is a common nosocomial infection and a frequent reason for empirical antibiotic therapy in NICUs. Ventilator associated pneumonia (VAP) is defined as a nosocomial lower airway infection in intubated patients with onset after 48 h or more of invasive mechanical ventilation.Prevention of VAP has been primarily achieved by the "bundle approach"; this involves the simultaneous application of several preventive strategies for all patients.In Egypt and other developing countries, reports on the success of VAP intervention strategies, particularly among neonates, are scarce. So, it is important to conduct educational programs for nurses about VAP to decrease its incidence.

Eligibility Criteria:
Inclusion Criteria:

* Gestational age ≥34 weeks
* Intubated newborns and those expected to receive mechanical ventilation for more than 48 hours.

Exclusion Criteria:

* Newborns with diagnosis of pneumonia at the time of admission.
* Newborns developed pneumonia in the first 48 hours of mechanical ventilation.
* Newborns subjected to reintubation.
* Immunosuppressed newborns.
Long-term Remote Ischemic Preconditioning Improve the Prognosis of Myocardial Infarction Patients With Emergency Reperfusion Therapy

Patients with acute myocardial infarction (AMI) are in critical condition. When primary percutaneous coronary intervention (PCI) was performing, no-reflow, reperfusion injury，heart failure, heart rupture, malignant arrhythmia maybe happen. It was reported remote ischemic preconditioning (RIPC) may play an effective endogenous cardiac protection. This study will investigate whether once RIPC before primary PCI or long-term RIPC can improve AMI patients short-term and long-term (1 year) prognosis. 400 STEMI patients undergoing primary PCI were randomly divided into 3 groups: long-term RIPC group (once preoperative RIPC and once RIPC/day after PCI), preoperative RIPC group (once preoperative RIPC), control group (without RIPC). Cardiac troponin (TNI), high-sensitivity C-reactive protein (hsCRP), adenosine, vascular endothelial growth factor (VEGF), hypoxia inducible factor-1 (HIF-1), echocardiography and magnetic resonance （MR）were detected 1 day, 1 month and 1 year after PCI. Patients will be followed up by telephone at the end of one year. The major adverse cardiovascular events (MACE) include cardiovascular death, spontaneous myocardial infarction, unplanned revascularization and stroke.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18-80 years;
* ST segment elevation myocardial infarction (STEMI);
* Plan to primary percutaneous coronary intervention.

Exclusion Criteria:

* Age more than 80;
* renal failure with creatinine \>2 mg/dl;
* reject taking part in the study.
Adequacy of Pain Treatment in Radiotherapy

Aim of the study is to evaluate adequacy of pain treatment in oncologic patients, accessing to Radiotherapy Unit

Prescription of analgesic drugs is a basic topic in cancer patients, but undertreatment is common. The aim of the study is to analyse pain control and adequacy of antalgic treatments in patients coming to Radiotherapy Unit for radiation treatment.

Eligibility Criteria:
Inclusion Criteria:

- patients accessing to Radiotherapy Unit for radiation treatment (both palliative or with radical intent) with diagnosis of primitive or metastatic cancer;

Exclusion Criteria:

- Concomitant diseases that can affect reliability of collected data
COVID-19 - Multicenter Study on Nosocomial Transmission of SARS-CoV-2 Virus

Infection with the SARS-CoV-2 coronavirus strain is associated with severe morbidity and mortality estimated today from 2% to 4%. Elderly patients or patients with serious chronic conditions justifying hospitalization are particularly at risk. The risk of infection with SARS-CoV-2 during hospitalization is also substantial and increased in fragile patients. Several cases of infection among Healthcare Professionals had been reported.

The hypothesis is that similar to the corona virus agent responsible for SRAS and the influenza virus, nosocomial outbreaks of SARS-CoV-2 to be feared. Health care professionals and caregivers are populations-at-risk as they are exposed in the community and can transmit SARS-CoV-2 to hospitalized patients, and are also exposed to hospitalized patients infected with SARS-CoV-2.

Describing hospital-acquired cases and SARS-CoV-2 infection transmission chains in healthcare settings is vitally essential to achieve control of this epidemic. To improve the quality of care and patient safety, this data must be accompanied by an analysis of the impact of infection control measures. In addition, an effective infection control program is urgently required to control the spread of the virus and protect both uninfected patients who require care for other medical or surgical conditions as well as health care professionals.

The main objective of this prospective, non-interventional - observational, hospital based study in adults and children is to describe and document suspected or confirmed cases of nosocomial SARS-CoV-2 infection, the clinical spectrum and the determinants (risk factors/protective factors) at participating hospitals.

Characterization of the clinical features of the SARS-CoV-2 infection will help to identify potential sources of virus transmission as rapidly as possible and enable implementation of appropriate hygiene practices in hospitals.


Eligibility Criteria:
Inclusion Criteria:

1 ) Any adult or child or member of the nursing staff from the study participant hospital who presents an infectious syndrome including the following definition :

2) Suspect Case:

Fever above 37.8 ° C if no antipyretics are taken; And or Cough or pharyngeal pain or other symptom suggestive of respiratory infection. AND at least 1 of the following characteristics:

* return from a trip to China, or to a country in which the increase in the incidence of infections in SARS-CoV-2 has been proven;
* close contact (sharing the same place of family, professional life, same plane, etc.) with a person defined as a suspected or confirmed case;
* Occurring in an establishment having received at least one case of suspected or confirmed infection at SARS-CoV-2.

Or 3) Confirmed Case: The same clinical definitions, in addition to a positive RT-PCR-type virological diagnostic result specific to SARS-CoV-2

Exclusion Criteria:

* Anyone who does not meet the above definition.